Clinical Psychiatry News

At its November meeting, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) voted against Biogen’s controversial Alzheimer’s drug aducanumab (Aduhelm), making it highly unlikely the drug will be recommended for approval at its December meeting.

In a news release issued Nov. 17, Biogen said the company received a “negative trend vote” on the aducanumab marketing authorization application in Europe.

“While we are disappointed with the trend vote, we strongly believe in the strength of our data and that aducanumab has the potential to make a positive and meaningful difference for people and families affected by Alzheimer’s disease [AD],” Priya Singhal, MD, MPH, head of global safety and regulatory sciences and interim head of research and development at Biogen, said in the release.

The EMA committee is expected to adopt a formal opinion on the marketing application at its December meeting (Dec. 13-16, 2021).

“Biogen will continue to engage with the EMA and CHMP as it considers next steps towards the goal of providing access to aducanumab to patients in Europe,” the company said.

At the recent Clinical Trials on Alzheimer’s Disease conference, Biogen announced new phase 3 findings that “provide further evidence of aducanumab’s effect on lowering amyloid beta plaque and downstream tau pathology, the two defining pathologies of Alzheimer’s disease,” the company said.
 

No clinically meaningful effect

In a statement from the nonprofit U.K. Science Media Centre, Prof. Robert Howard, from University College London, said the result of the CHMP vote “is absolutely the decision that we should have expected from the EMA’s expert advisory panel and is consistent with the FDA’s [U.S. Food and Drug Administration’s] Advisory Committee who voted unanimously 12 months ago against approval of aducanumab because of a lack of demonstrable efficacy in the pivotal phase 3 trials ENGAGE and EMERGE.”

“The FDA’s accelerated approval of aducanumab, solely on the grounds that it was reasonable to expect that reduction in amyloid would lead to improvement in the course of Alzheimer’s disease, despite all the evidence indicating no meaningful correlation between amyloid reduction and symptom improvement, has been highly controversial and has called into question the impartiality of the FDA and its staff,” Prof. Howard noted.

He anticipates that when the EMA panel meets in December they will not grant a license to aducanumab.

“Aducanumab is a treatment without convincing efficacy, with serious associated adverse effects and a high financial cost. On the basis of the available evidence and in the best interests of people with Alzheimer’s disease, their families and those who care for them, EMA and MHRA [Medicines and Healthcare products Regulatory Agency] should not approve a license for aducanumab,” Prof. Howard said.

Also weighing in, David Thomas, head of policy at Alzheimer’s Research UK, said the need for new AD treatments is “urgent,” but added that “it’s vital that regulators judge that any new treatment is safe and effective.”

“Results of aducanumab’s phase 3 trials, EMERGE and ENGAGE, have sparked much debate among the research community about how to judge the effectiveness of any new Alzheimer’s treatment,” Mr. Thomas noted.

“The FDA’s approval of aducanumab in the U.S. was based on the drug’s ability to clear the hallmark Alzheimer’s protein amyloid from the brain. As part of this approval the regulator now requires further trials to be carried out to ensure that aducanumab brings long-term improvement to people’s memory, thinking and day-to-day lives,” Mr. Thomas said.

EMA is now undertaking its own review of the data and “it’s important that we wait for the committee’s official recommendation, which is expected next month. In the meantime, we must continue to work at pace to ensure researchers are developing a broad pipeline of potential new treatments for diseases like Alzheimer’s, and that health systems like the NHS [National Health Service] will be ready to deliver them in the years ahead,” he added.
 

‘Reckless’ FDA decision

In related news, the Centers for Medicare and Medicaid Services (CMS) has announced that the Medicare Part B standard premium would rise to $170 per month for all enrollees, a 15% spike over the 2021 premium level.

“All Part B Medicare beneficiaries soon will be forced to bear significant financial burden as a direct result of the FDA’s reckless decision to approve aducanumab, a drug that has not been proven to provide any clinically meaningful benefit to Alzheimer’s patients but nevertheless carries an indefensible annual price tag set by Biogen at $56,000 per year for just the drug alone,” Michael Carome, MD, director of Public Citizen’s Health Research Group, said in a statement.

“To protect the many Medicare beneficiaries who cannot afford the unacceptable 15% jump in Part B premiums, CMS must promptly announce that it will exclude aducanumab from coverage under the Medicare program until there is definitive evidence that the drug provides substantial evidence of cognitive benefit to Alzheimer’s disease patients,” Dr. Carome said.

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

At its November meeting, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) voted against Biogen’s controversial Alzheimer’s drug aducanumab (Aduhelm), making it highly unlikely the drug will be recommended for approval at its December meeting.

In a news release issued Nov. 17, Biogen said the company received a “negative trend vote” on the aducanumab marketing authorization application in Europe.

“While we are disappointed with the trend vote, we strongly believe in the strength of our data and that aducanumab has the potential to make a positive and meaningful difference for people and families affected by Alzheimer’s disease [AD],” Priya Singhal, MD, MPH, head of global safety and regulatory sciences and interim head of research and development at Biogen, said in the release.

The EMA committee is expected to adopt a formal opinion on the marketing application at its December meeting (Dec. 13-16, 2021).

“Biogen will continue to engage with the EMA and CHMP as it considers next steps towards the goal of providing access to aducanumab to patients in Europe,” the company said.

At the recent Clinical Trials on Alzheimer’s Disease conference, Biogen announced new phase 3 findings that “provide further evidence of aducanumab’s effect on lowering amyloid beta plaque and downstream tau pathology, the two defining pathologies of Alzheimer’s disease,” the company said.
 

No clinically meaningful effect

In a statement from the nonprofit U.K. Science Media Centre, Prof. Robert Howard, from University College London, said the result of the CHMP vote “is absolutely the decision that we should have expected from the EMA’s expert advisory panel and is consistent with the FDA’s [U.S. Food and Drug Administration’s] Advisory Committee who voted unanimously 12 months ago against approval of aducanumab because of a lack of demonstrable efficacy in the pivotal phase 3 trials ENGAGE and EMERGE.”

“The FDA’s accelerated approval of aducanumab, solely on the grounds that it was reasonable to expect that reduction in amyloid would lead to improvement in the course of Alzheimer’s disease, despite all the evidence indicating no meaningful correlation between amyloid reduction and symptom improvement, has been highly controversial and has called into question the impartiality of the FDA and its staff,” Prof. Howard noted.

He anticipates that when the EMA panel meets in December they will not grant a license to aducanumab.

“Aducanumab is a treatment without convincing efficacy, with serious associated adverse effects and a high financial cost. On the basis of the available evidence and in the best interests of people with Alzheimer’s disease, their families and those who care for them, EMA and MHRA [Medicines and Healthcare products Regulatory Agency] should not approve a license for aducanumab,” Prof. Howard said.

Also weighing in, David Thomas, head of policy at Alzheimer’s Research UK, said the need for new AD treatments is “urgent,” but added that “it’s vital that regulators judge that any new treatment is safe and effective.”

“Results of aducanumab’s phase 3 trials, EMERGE and ENGAGE, have sparked much debate among the research community about how to judge the effectiveness of any new Alzheimer’s treatment,” Mr. Thomas noted.

“The FDA’s approval of aducanumab in the U.S. was based on the drug’s ability to clear the hallmark Alzheimer’s protein amyloid from the brain. As part of this approval the regulator now requires further trials to be carried out to ensure that aducanumab brings long-term improvement to people’s memory, thinking and day-to-day lives,” Mr. Thomas said.

EMA is now undertaking its own review of the data and “it’s important that we wait for the committee’s official recommendation, which is expected next month. In the meantime, we must continue to work at pace to ensure researchers are developing a broad pipeline of potential new treatments for diseases like Alzheimer’s, and that health systems like the NHS [National Health Service] will be ready to deliver them in the years ahead,” he added.
 

‘Reckless’ FDA decision

In related news, the Centers for Medicare and Medicaid Services (CMS) has announced that the Medicare Part B standard premium would rise to $170 per month for all enrollees, a 15% spike over the 2021 premium level.

“All Part B Medicare beneficiaries soon will be forced to bear significant financial burden as a direct result of the FDA’s reckless decision to approve aducanumab, a drug that has not been proven to provide any clinically meaningful benefit to Alzheimer’s patients but nevertheless carries an indefensible annual price tag set by Biogen at $56,000 per year for just the drug alone,” Michael Carome, MD, director of Public Citizen’s Health Research Group, said in a statement.

“To protect the many Medicare beneficiaries who cannot afford the unacceptable 15% jump in Part B premiums, CMS must promptly announce that it will exclude aducanumab from coverage under the Medicare program until there is definitive evidence that the drug provides substantial evidence of cognitive benefit to Alzheimer’s disease patients,” Dr. Carome said.

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

At its November meeting, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) voted against Biogen’s controversial Alzheimer’s drug aducanumab (Aduhelm), making it highly unlikely the drug will be recommended for approval at its December meeting.

In a news release issued Nov. 17, Biogen said the company received a “negative trend vote” on the aducanumab marketing authorization application in Europe.

“While we are disappointed with the trend vote, we strongly believe in the strength of our data and that aducanumab has the potential to make a positive and meaningful difference for people and families affected by Alzheimer’s disease [AD],” Priya Singhal, MD, MPH, head of global safety and regulatory sciences and interim head of research and development at Biogen, said in the release.

The EMA committee is expected to adopt a formal opinion on the marketing application at its December meeting (Dec. 13-16, 2021).

“Biogen will continue to engage with the EMA and CHMP as it considers next steps towards the goal of providing access to aducanumab to patients in Europe,” the company said.

At the recent Clinical Trials on Alzheimer’s Disease conference, Biogen announced new phase 3 findings that “provide further evidence of aducanumab’s effect on lowering amyloid beta plaque and downstream tau pathology, the two defining pathologies of Alzheimer’s disease,” the company said.
 

No clinically meaningful effect

In a statement from the nonprofit U.K. Science Media Centre, Prof. Robert Howard, from University College London, said the result of the CHMP vote “is absolutely the decision that we should have expected from the EMA’s expert advisory panel and is consistent with the FDA’s [U.S. Food and Drug Administration’s] Advisory Committee who voted unanimously 12 months ago against approval of aducanumab because of a lack of demonstrable efficacy in the pivotal phase 3 trials ENGAGE and EMERGE.”

“The FDA’s accelerated approval of aducanumab, solely on the grounds that it was reasonable to expect that reduction in amyloid would lead to improvement in the course of Alzheimer’s disease, despite all the evidence indicating no meaningful correlation between amyloid reduction and symptom improvement, has been highly controversial and has called into question the impartiality of the FDA and its staff,” Prof. Howard noted.

He anticipates that when the EMA panel meets in December they will not grant a license to aducanumab.

“Aducanumab is a treatment without convincing efficacy, with serious associated adverse effects and a high financial cost. On the basis of the available evidence and in the best interests of people with Alzheimer’s disease, their families and those who care for them, EMA and MHRA [Medicines and Healthcare products Regulatory Agency] should not approve a license for aducanumab,” Prof. Howard said.

Also weighing in, David Thomas, head of policy at Alzheimer’s Research UK, said the need for new AD treatments is “urgent,” but added that “it’s vital that regulators judge that any new treatment is safe and effective.”

“Results of aducanumab’s phase 3 trials, EMERGE and ENGAGE, have sparked much debate among the research community about how to judge the effectiveness of any new Alzheimer’s treatment,” Mr. Thomas noted.

“The FDA’s approval of aducanumab in the U.S. was based on the drug’s ability to clear the hallmark Alzheimer’s protein amyloid from the brain. As part of this approval the regulator now requires further trials to be carried out to ensure that aducanumab brings long-term improvement to people’s memory, thinking and day-to-day lives,” Mr. Thomas said.

EMA is now undertaking its own review of the data and “it’s important that we wait for the committee’s official recommendation, which is expected next month. In the meantime, we must continue to work at pace to ensure researchers are developing a broad pipeline of potential new treatments for diseases like Alzheimer’s, and that health systems like the NHS [National Health Service] will be ready to deliver them in the years ahead,” he added.
 

‘Reckless’ FDA decision

In related news, the Centers for Medicare and Medicaid Services (CMS) has announced that the Medicare Part B standard premium would rise to $170 per month for all enrollees, a 15% spike over the 2021 premium level.

“All Part B Medicare beneficiaries soon will be forced to bear significant financial burden as a direct result of the FDA’s reckless decision to approve aducanumab, a drug that has not been proven to provide any clinically meaningful benefit to Alzheimer’s patients but nevertheless carries an indefensible annual price tag set by Biogen at $56,000 per year for just the drug alone,” Michael Carome, MD, director of Public Citizen’s Health Research Group, said in a statement.

“To protect the many Medicare beneficiaries who cannot afford the unacceptable 15% jump in Part B premiums, CMS must promptly announce that it will exclude aducanumab from coverage under the Medicare program until there is definitive evidence that the drug provides substantial evidence of cognitive benefit to Alzheimer’s disease patients,” Dr. Carome said.

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

The Centers for Disease Control and Prevention reported that an estimated 100,306 Americans died from drug overdoses during the period from April 2020 to April 2021, a 28.5% increase from the previous year.

Deaths in some states rose even more precipitously. Vermont saw an almost 70% increase, and drug overdose deaths in West Virginia increased by 62%. Many states, including Alabama, California, Kansas, Kentucky, Louisiana, Tennessee, and Washington, had a 45%-50% rise in overdose deaths.

The data released by the CDC was provisional, as there is generally a lag between a reported overdose and confirmation of the death to the National Vital Statistics System. The agency uses statistical models that render the counts almost 100% accurate, the CDC says.

The vast majority (73,757) of overdose deaths involved opioids – with most of those (62,338) involving synthetic opioids such as fentanyl. Federal officials said that one American died every 5 minutes from an overdose, or 265 a day.

“We have to acknowledge what this is – it is a crisis,” Department of Health & Human Services Secretary Xavier Becerra told reporters on a call.

“As much as the numbers speak so vividly, they don’t tell the whole story. We see it in the faces of grieving families and all those overworked caregivers. You hear it every time you get that panicked 911 phone call, you read it in obituaries of sons and daughters who left us way too soon,” Mr. Becerra said.

Rahul Gupta, MD, director of the White House Office of National Drug Control Policy, said that “this is unacceptable, and it requires an unprecedented response.”

Dr. Gupta, who noted that he has a waiver to treat substance use disorder patients with buprenorphine, said he’s seen “first-hand the heartbreak of the overdose epidemic,” adding that, with 23 years in practice, “I’ve learned that an overdose is a cry for help and for far too many people that cry goes unanswered.”

Both Mr. Becerra and Dr. Gupta called on Congress to pass President Joe Biden’s fiscal 2022 budget request, noting that it calls for $41 billion – a $669 million increase from fiscal year 2021 – to go to agencies working on drug interdiction and substance use prevention, treatment, and recovery support. 

Dr. Gupta also announced that the administration was releasing a model law that could be used by state legislatures to help standardize policies on making the overdose antidote naloxone more accessible. Currently, such policies are a patchwork across the nation.

In addition, the federal government is newly supporting harm reduction, Mr. Becerra said. This means federal money can be used by clinics and outreach programs to buy fentanyl test strips, which they can then distribute to drug users.

“It’s important for Americans to have the ability to make sure that they can test for fentanyl in the substance,” Dr. Gupta said.
 

Fake pills, fentanyl a huge issue

Federal officials said that both fentanyl and methamphetamine are contributing to rising numbers of fatalities.

“Drug cartels in Mexico are mass-producing fentanyl and methamphetamine largely sourced from chemicals in China and they are distributing these substances throughout the United States,” Anne Milgram, administrator of the Drug Enforcement Administration, said on the call.

Ms. Milgram said the agency had seized 12,000 pounds of fentanyl in 2021, enough to provide every American with a lethal dose. Fentanyl is also mixed in with cocaine, heroin, methamphetamine, and marijuana – often in counterfeit pills, Ms. Milgram said.

The DEA and other law enforcement agencies have seized more than 14 million such pills in 2021. “These types of pills are easily accessible today on social media and e-commerce platforms, Ms. Milgram said.

“Drug dealers are now in our homes,” she said. “Wherever there is a smart phone or a computer, a dealer is one click away,” Ms. Milgram said.

National Institute on Drug Abuse Director Nora D. Volkow, MD, said that dealers will continue to push both fentanyl and methamphetamine because they are among the most addictive substances. They also are more profitable because they don’t require cultivation and harvesting, she said on the call.

Dr. Volkow also noted that naloxone is not as effective in reversing fentanyl overdoses because fentanyl is more potent than heroin and other opioids, and “it gets into the brain extremely rapidly.”

Ongoing research is aimed at developing a faster delivery mechanism and a longer-lasting formulation to counter overdoses, Dr. Volkow said.

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

The Centers for Disease Control and Prevention reported that an estimated 100,306 Americans died from drug overdoses during the period from April 2020 to April 2021, a 28.5% increase from the previous year.

Deaths in some states rose even more precipitously. Vermont saw an almost 70% increase, and drug overdose deaths in West Virginia increased by 62%. Many states, including Alabama, California, Kansas, Kentucky, Louisiana, Tennessee, and Washington, had a 45%-50% rise in overdose deaths.

The data released by the CDC was provisional, as there is generally a lag between a reported overdose and confirmation of the death to the National Vital Statistics System. The agency uses statistical models that render the counts almost 100% accurate, the CDC says.

The vast majority (73,757) of overdose deaths involved opioids – with most of those (62,338) involving synthetic opioids such as fentanyl. Federal officials said that one American died every 5 minutes from an overdose, or 265 a day.

“We have to acknowledge what this is – it is a crisis,” Department of Health & Human Services Secretary Xavier Becerra told reporters on a call.

“As much as the numbers speak so vividly, they don’t tell the whole story. We see it in the faces of grieving families and all those overworked caregivers. You hear it every time you get that panicked 911 phone call, you read it in obituaries of sons and daughters who left us way too soon,” Mr. Becerra said.

Rahul Gupta, MD, director of the White House Office of National Drug Control Policy, said that “this is unacceptable, and it requires an unprecedented response.”

Dr. Gupta, who noted that he has a waiver to treat substance use disorder patients with buprenorphine, said he’s seen “first-hand the heartbreak of the overdose epidemic,” adding that, with 23 years in practice, “I’ve learned that an overdose is a cry for help and for far too many people that cry goes unanswered.”

Both Mr. Becerra and Dr. Gupta called on Congress to pass President Joe Biden’s fiscal 2022 budget request, noting that it calls for $41 billion – a $669 million increase from fiscal year 2021 – to go to agencies working on drug interdiction and substance use prevention, treatment, and recovery support. 

Dr. Gupta also announced that the administration was releasing a model law that could be used by state legislatures to help standardize policies on making the overdose antidote naloxone more accessible. Currently, such policies are a patchwork across the nation.

In addition, the federal government is newly supporting harm reduction, Mr. Becerra said. This means federal money can be used by clinics and outreach programs to buy fentanyl test strips, which they can then distribute to drug users.

“It’s important for Americans to have the ability to make sure that they can test for fentanyl in the substance,” Dr. Gupta said.
 

Fake pills, fentanyl a huge issue

Federal officials said that both fentanyl and methamphetamine are contributing to rising numbers of fatalities.

“Drug cartels in Mexico are mass-producing fentanyl and methamphetamine largely sourced from chemicals in China and they are distributing these substances throughout the United States,” Anne Milgram, administrator of the Drug Enforcement Administration, said on the call.

Ms. Milgram said the agency had seized 12,000 pounds of fentanyl in 2021, enough to provide every American with a lethal dose. Fentanyl is also mixed in with cocaine, heroin, methamphetamine, and marijuana – often in counterfeit pills, Ms. Milgram said.

The DEA and other law enforcement agencies have seized more than 14 million such pills in 2021. “These types of pills are easily accessible today on social media and e-commerce platforms, Ms. Milgram said.

“Drug dealers are now in our homes,” she said. “Wherever there is a smart phone or a computer, a dealer is one click away,” Ms. Milgram said.

National Institute on Drug Abuse Director Nora D. Volkow, MD, said that dealers will continue to push both fentanyl and methamphetamine because they are among the most addictive substances. They also are more profitable because they don’t require cultivation and harvesting, she said on the call.

Dr. Volkow also noted that naloxone is not as effective in reversing fentanyl overdoses because fentanyl is more potent than heroin and other opioids, and “it gets into the brain extremely rapidly.”

Ongoing research is aimed at developing a faster delivery mechanism and a longer-lasting formulation to counter overdoses, Dr. Volkow said.

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

The Centers for Disease Control and Prevention reported that an estimated 100,306 Americans died from drug overdoses during the period from April 2020 to April 2021, a 28.5% increase from the previous year.

Deaths in some states rose even more precipitously. Vermont saw an almost 70% increase, and drug overdose deaths in West Virginia increased by 62%. Many states, including Alabama, California, Kansas, Kentucky, Louisiana, Tennessee, and Washington, had a 45%-50% rise in overdose deaths.

The data released by the CDC was provisional, as there is generally a lag between a reported overdose and confirmation of the death to the National Vital Statistics System. The agency uses statistical models that render the counts almost 100% accurate, the CDC says.

The vast majority (73,757) of overdose deaths involved opioids – with most of those (62,338) involving synthetic opioids such as fentanyl. Federal officials said that one American died every 5 minutes from an overdose, or 265 a day.

“We have to acknowledge what this is – it is a crisis,” Department of Health & Human Services Secretary Xavier Becerra told reporters on a call.

“As much as the numbers speak so vividly, they don’t tell the whole story. We see it in the faces of grieving families and all those overworked caregivers. You hear it every time you get that panicked 911 phone call, you read it in obituaries of sons and daughters who left us way too soon,” Mr. Becerra said.

Rahul Gupta, MD, director of the White House Office of National Drug Control Policy, said that “this is unacceptable, and it requires an unprecedented response.”

Dr. Gupta, who noted that he has a waiver to treat substance use disorder patients with buprenorphine, said he’s seen “first-hand the heartbreak of the overdose epidemic,” adding that, with 23 years in practice, “I’ve learned that an overdose is a cry for help and for far too many people that cry goes unanswered.”

Both Mr. Becerra and Dr. Gupta called on Congress to pass President Joe Biden’s fiscal 2022 budget request, noting that it calls for $41 billion – a $669 million increase from fiscal year 2021 – to go to agencies working on drug interdiction and substance use prevention, treatment, and recovery support. 

Dr. Gupta also announced that the administration was releasing a model law that could be used by state legislatures to help standardize policies on making the overdose antidote naloxone more accessible. Currently, such policies are a patchwork across the nation.

In addition, the federal government is newly supporting harm reduction, Mr. Becerra said. This means federal money can be used by clinics and outreach programs to buy fentanyl test strips, which they can then distribute to drug users.

“It’s important for Americans to have the ability to make sure that they can test for fentanyl in the substance,” Dr. Gupta said.
 

Fake pills, fentanyl a huge issue

Federal officials said that both fentanyl and methamphetamine are contributing to rising numbers of fatalities.

“Drug cartels in Mexico are mass-producing fentanyl and methamphetamine largely sourced from chemicals in China and they are distributing these substances throughout the United States,” Anne Milgram, administrator of the Drug Enforcement Administration, said on the call.

Ms. Milgram said the agency had seized 12,000 pounds of fentanyl in 2021, enough to provide every American with a lethal dose. Fentanyl is also mixed in with cocaine, heroin, methamphetamine, and marijuana – often in counterfeit pills, Ms. Milgram said.

The DEA and other law enforcement agencies have seized more than 14 million such pills in 2021. “These types of pills are easily accessible today on social media and e-commerce platforms, Ms. Milgram said.

“Drug dealers are now in our homes,” she said. “Wherever there is a smart phone or a computer, a dealer is one click away,” Ms. Milgram said.

National Institute on Drug Abuse Director Nora D. Volkow, MD, said that dealers will continue to push both fentanyl and methamphetamine because they are among the most addictive substances. They also are more profitable because they don’t require cultivation and harvesting, she said on the call.

Dr. Volkow also noted that naloxone is not as effective in reversing fentanyl overdoses because fentanyl is more potent than heroin and other opioids, and “it gets into the brain extremely rapidly.”

Ongoing research is aimed at developing a faster delivery mechanism and a longer-lasting formulation to counter overdoses, Dr. Volkow said.

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

Deer, COVID, how?

Usually humans cannot get close enough to a deer to really be face-to-face, so it’s easy to question how on Earth deer are contracting COVID-19. Well, stranger things have happened, and honestly, we’ve just stopped questioning most of them.

petemeade/PxHere

Exhibit A comes to us from a Penn State University study: Eighty percent of deer sampled in Iowa in December 2020 and January 2021 – as part of the state’s chronic wasting disease surveillance program – were found to be positive for COVID-19.

A statement from the university said that “white-tailed deer may be a reservoir for the virus to continually circulate and raise concerns about the emergence of new strains that may prove a threat to wildlife and, possibly, to humans.” The investigators also suggested that deer probably caught the virus from humans and then transmitted it to other deer.

If you or someone you know is a hunter or a white-tailed deer, it’s best to proceed with caution. There’s no evidence that COVID-19 has jumped from deer to humans, but hunters should wear masks and gloves while working with deer, worrying not just about the deer’s face, but also … you know, the gastrointestinal parts, Robert Salata, MD, of University Hospitals Cleveland Medical Center, told Syracuse.com. It also shouldn’t be too risky to eat venison, he said, just make sure the meat is cooked thoroughly.

The more you know!
 

The neurological super powers of grandma are real

What is it about grandmothers that makes them seem almost magical at times? They somehow always know how you feel. And they can almost always tell when something is wrong. They also seem to be the biggest ally a child will have against his or her parents.

Mark Edward Atkinson/Tracey Lee

So what makes these super matriarchs? The answer is in the brain.

Apparently there’s a function in the brains of grandmothers geared toward “emotional empathy.” James Rilling, PhD, of Emory University, lead author of a recent study focused on looking at the brain function of grandmothers, suggested that they’re neurologically tapped into feeling how their grandchildren feel: “If their grandchild is smiling, they’re feeling the child’s joy. And if their grandchild is crying, they’re feeling the child’s pain and distress.”

And then there’s the cute factor. Never underestimate a child’s ability to manipulate his or her grandmother’s brain.

So how do the researchers know this? Functional MRI showed more brain activity in the parts of the brain that deal with emotional empathy and movement in the participating grandmas when shown pictures of their grandchildren. Images of their own adult children lit up areas more associated with cognitive empathy. So less emotional and more mental/logical understanding.

Kids, don’t tell Mom about the secret midnight snacks with grandma. She wouldn’t get it.

Then there’s the grandmother hypothesis, which suggests that women tend to live longer to provide some kind of evolutionary benefit to their children and grandchildren. Evidence also exists that children with positive engagement from their grandmothers tend to have better social and academic outcomes, behavior, and physical health.

A lot of credit on how children turn out, of course, goes to parents, but more can be said about grandmas. Don’t let the age and freshly baked cookies fool you. They have neurologic superpowers within.
 

Brain cleanup on aisle 5

You’ve got your local grocery store down. You know the ins and outs; you know where everything is. Last week you did your trip in record time. This week, however, you have to stop at a different store. Same chain, but a different location. You stroll in, confidently walk toward the first aisle for your fruits and veggies, and ... it’s all ice cream. Oops.

Max Pixel

There’s a lot we don’t understand about the brain, including how it remembers familiar environments to avoid confusion. Or why it fails to do so, as with our grocery store example. However, thanks to a study from the University of Arizona, we may have an answer.

For the experiment, a group of participants watched a video tour of three virtual cities. Those cities were very similar, being laid out in basically identical fashion. Stores could be found in the same places, but the identity of those stores varied. Some stores were in all three cities, some were in two, and some were unique. Participants were asked to memorize the layouts, and those who got things more than 80% correct ran through the test again, only this time their brain activity was monitored through MRI.

In general, brain activity was similar for the participants; after all, they were recalling similar environments. However, when asked about stores that appeared in multiple cities, brain activity varied dramatically. This indicated to the researchers that the brain was recalling shared stores as if they were more dissimilar than two completely disparate and unique stores, a concept often known to brain scientists as “repulsion.” It also indicates that the memories regarding shared environments are stored in the prefrontal cortex, not the hippocampus, which typically handles memory.

The researchers plan to apply this information to questions about diseases such as Alzheimer’s, so the next time you get turned around in a weirdly unfamiliar grocery store, just think: “It’s okay, I’m helping to solve a terrible brain disease.”
 

The real endgame: Friction is the winner

Spoiler alert! If you haven’t seen “Avengers: Infinity War” yet, we’re about to ruin it for you.

Georgia Tech

For those still with us, here’s the spoiler: Thanos would not have been able to snap his fingers while wearing the Infinity Gauntlet.

Saad Bhamla, PhD, of Georgia Tech University’s school of chemical and biomolecular engineering, had been studying powerful and ultrafast motions in living organisms along with several colleagues before the movie came out in 2018, and when they saw the finger-snapping scene it got them wondering.

Being scientists of course, they had no choice. They got out their high-speed imaging equipment, automated image processing software, and dynamic force sensors and analyzed finger snaps, paying close attention to friction by covering fingers with “different materials, including metallic thimbles to simulate the effects of trying to snap while wearing a metallic gauntlet, much like Thanos,” according to a statement on Eurekalert.

With finger snaps, it’s all about the rotational velocity. The angular acceleration involved is the fastest ever measured in a human, with a professional baseball pitcher’s throwing arm a distant second.

Dr. Bhamla’s reaction to their work explains why scientists are the ones doing science. “When I first saw the data, I jumped out of my chair,” he said in the written statement.

Rotational velocities dropped dramatically when the friction-reducing thimbles were used, so there was no snap. Which means that billions and billions of fictional lives could have been saved if the filmmakers had just talked to the right scientist.

That scientist, clearly, is Dr. Bhamla, who said that “this is the only scientific project in my lab in which we could snap our fingers and get data.”

Deer, COVID, how?

Usually humans cannot get close enough to a deer to really be face-to-face, so it’s easy to question how on Earth deer are contracting COVID-19. Well, stranger things have happened, and honestly, we’ve just stopped questioning most of them.

petemeade/PxHere

Exhibit A comes to us from a Penn State University study: Eighty percent of deer sampled in Iowa in December 2020 and January 2021 – as part of the state’s chronic wasting disease surveillance program – were found to be positive for COVID-19.

A statement from the university said that “white-tailed deer may be a reservoir for the virus to continually circulate and raise concerns about the emergence of new strains that may prove a threat to wildlife and, possibly, to humans.” The investigators also suggested that deer probably caught the virus from humans and then transmitted it to other deer.

If you or someone you know is a hunter or a white-tailed deer, it’s best to proceed with caution. There’s no evidence that COVID-19 has jumped from deer to humans, but hunters should wear masks and gloves while working with deer, worrying not just about the deer’s face, but also … you know, the gastrointestinal parts, Robert Salata, MD, of University Hospitals Cleveland Medical Center, told Syracuse.com. It also shouldn’t be too risky to eat venison, he said, just make sure the meat is cooked thoroughly.

The more you know!
 

The neurological super powers of grandma are real

What is it about grandmothers that makes them seem almost magical at times? They somehow always know how you feel. And they can almost always tell when something is wrong. They also seem to be the biggest ally a child will have against his or her parents.

Mark Edward Atkinson/Tracey Lee

So what makes these super matriarchs? The answer is in the brain.

Apparently there’s a function in the brains of grandmothers geared toward “emotional empathy.” James Rilling, PhD, of Emory University, lead author of a recent study focused on looking at the brain function of grandmothers, suggested that they’re neurologically tapped into feeling how their grandchildren feel: “If their grandchild is smiling, they’re feeling the child’s joy. And if their grandchild is crying, they’re feeling the child’s pain and distress.”

And then there’s the cute factor. Never underestimate a child’s ability to manipulate his or her grandmother’s brain.

So how do the researchers know this? Functional MRI showed more brain activity in the parts of the brain that deal with emotional empathy and movement in the participating grandmas when shown pictures of their grandchildren. Images of their own adult children lit up areas more associated with cognitive empathy. So less emotional and more mental/logical understanding.

Kids, don’t tell Mom about the secret midnight snacks with grandma. She wouldn’t get it.

Then there’s the grandmother hypothesis, which suggests that women tend to live longer to provide some kind of evolutionary benefit to their children and grandchildren. Evidence also exists that children with positive engagement from their grandmothers tend to have better social and academic outcomes, behavior, and physical health.

A lot of credit on how children turn out, of course, goes to parents, but more can be said about grandmas. Don’t let the age and freshly baked cookies fool you. They have neurologic superpowers within.
 

Brain cleanup on aisle 5

You’ve got your local grocery store down. You know the ins and outs; you know where everything is. Last week you did your trip in record time. This week, however, you have to stop at a different store. Same chain, but a different location. You stroll in, confidently walk toward the first aisle for your fruits and veggies, and ... it’s all ice cream. Oops.

Max Pixel

There’s a lot we don’t understand about the brain, including how it remembers familiar environments to avoid confusion. Or why it fails to do so, as with our grocery store example. However, thanks to a study from the University of Arizona, we may have an answer.

For the experiment, a group of participants watched a video tour of three virtual cities. Those cities were very similar, being laid out in basically identical fashion. Stores could be found in the same places, but the identity of those stores varied. Some stores were in all three cities, some were in two, and some were unique. Participants were asked to memorize the layouts, and those who got things more than 80% correct ran through the test again, only this time their brain activity was monitored through MRI.

In general, brain activity was similar for the participants; after all, they were recalling similar environments. However, when asked about stores that appeared in multiple cities, brain activity varied dramatically. This indicated to the researchers that the brain was recalling shared stores as if they were more dissimilar than two completely disparate and unique stores, a concept often known to brain scientists as “repulsion.” It also indicates that the memories regarding shared environments are stored in the prefrontal cortex, not the hippocampus, which typically handles memory.

The researchers plan to apply this information to questions about diseases such as Alzheimer’s, so the next time you get turned around in a weirdly unfamiliar grocery store, just think: “It’s okay, I’m helping to solve a terrible brain disease.”
 

The real endgame: Friction is the winner

Spoiler alert! If you haven’t seen “Avengers: Infinity War” yet, we’re about to ruin it for you.

Georgia Tech

For those still with us, here’s the spoiler: Thanos would not have been able to snap his fingers while wearing the Infinity Gauntlet.

Saad Bhamla, PhD, of Georgia Tech University’s school of chemical and biomolecular engineering, had been studying powerful and ultrafast motions in living organisms along with several colleagues before the movie came out in 2018, and when they saw the finger-snapping scene it got them wondering.

Being scientists of course, they had no choice. They got out their high-speed imaging equipment, automated image processing software, and dynamic force sensors and analyzed finger snaps, paying close attention to friction by covering fingers with “different materials, including metallic thimbles to simulate the effects of trying to snap while wearing a metallic gauntlet, much like Thanos,” according to a statement on Eurekalert.

With finger snaps, it’s all about the rotational velocity. The angular acceleration involved is the fastest ever measured in a human, with a professional baseball pitcher’s throwing arm a distant second.

Dr. Bhamla’s reaction to their work explains why scientists are the ones doing science. “When I first saw the data, I jumped out of my chair,” he said in the written statement.

Rotational velocities dropped dramatically when the friction-reducing thimbles were used, so there was no snap. Which means that billions and billions of fictional lives could have been saved if the filmmakers had just talked to the right scientist.

That scientist, clearly, is Dr. Bhamla, who said that “this is the only scientific project in my lab in which we could snap our fingers and get data.”

Deer, COVID, how?

Usually humans cannot get close enough to a deer to really be face-to-face, so it’s easy to question how on Earth deer are contracting COVID-19. Well, stranger things have happened, and honestly, we’ve just stopped questioning most of them.

petemeade/PxHere

Exhibit A comes to us from a Penn State University study: Eighty percent of deer sampled in Iowa in December 2020 and January 2021 – as part of the state’s chronic wasting disease surveillance program – were found to be positive for COVID-19.

A statement from the university said that “white-tailed deer may be a reservoir for the virus to continually circulate and raise concerns about the emergence of new strains that may prove a threat to wildlife and, possibly, to humans.” The investigators also suggested that deer probably caught the virus from humans and then transmitted it to other deer.

If you or someone you know is a hunter or a white-tailed deer, it’s best to proceed with caution. There’s no evidence that COVID-19 has jumped from deer to humans, but hunters should wear masks and gloves while working with deer, worrying not just about the deer’s face, but also … you know, the gastrointestinal parts, Robert Salata, MD, of University Hospitals Cleveland Medical Center, told Syracuse.com. It also shouldn’t be too risky to eat venison, he said, just make sure the meat is cooked thoroughly.

The more you know!
 

The neurological super powers of grandma are real

What is it about grandmothers that makes them seem almost magical at times? They somehow always know how you feel. And they can almost always tell when something is wrong. They also seem to be the biggest ally a child will have against his or her parents.

Mark Edward Atkinson/Tracey Lee

So what makes these super matriarchs? The answer is in the brain.

Apparently there’s a function in the brains of grandmothers geared toward “emotional empathy.” James Rilling, PhD, of Emory University, lead author of a recent study focused on looking at the brain function of grandmothers, suggested that they’re neurologically tapped into feeling how their grandchildren feel: “If their grandchild is smiling, they’re feeling the child’s joy. And if their grandchild is crying, they’re feeling the child’s pain and distress.”

And then there’s the cute factor. Never underestimate a child’s ability to manipulate his or her grandmother’s brain.

So how do the researchers know this? Functional MRI showed more brain activity in the parts of the brain that deal with emotional empathy and movement in the participating grandmas when shown pictures of their grandchildren. Images of their own adult children lit up areas more associated with cognitive empathy. So less emotional and more mental/logical understanding.

Kids, don’t tell Mom about the secret midnight snacks with grandma. She wouldn’t get it.

Then there’s the grandmother hypothesis, which suggests that women tend to live longer to provide some kind of evolutionary benefit to their children and grandchildren. Evidence also exists that children with positive engagement from their grandmothers tend to have better social and academic outcomes, behavior, and physical health.

A lot of credit on how children turn out, of course, goes to parents, but more can be said about grandmas. Don’t let the age and freshly baked cookies fool you. They have neurologic superpowers within.
 

Brain cleanup on aisle 5

You’ve got your local grocery store down. You know the ins and outs; you know where everything is. Last week you did your trip in record time. This week, however, you have to stop at a different store. Same chain, but a different location. You stroll in, confidently walk toward the first aisle for your fruits and veggies, and ... it’s all ice cream. Oops.

Max Pixel

There’s a lot we don’t understand about the brain, including how it remembers familiar environments to avoid confusion. Or why it fails to do so, as with our grocery store example. However, thanks to a study from the University of Arizona, we may have an answer.

For the experiment, a group of participants watched a video tour of three virtual cities. Those cities were very similar, being laid out in basically identical fashion. Stores could be found in the same places, but the identity of those stores varied. Some stores were in all three cities, some were in two, and some were unique. Participants were asked to memorize the layouts, and those who got things more than 80% correct ran through the test again, only this time their brain activity was monitored through MRI.

In general, brain activity was similar for the participants; after all, they were recalling similar environments. However, when asked about stores that appeared in multiple cities, brain activity varied dramatically. This indicated to the researchers that the brain was recalling shared stores as if they were more dissimilar than two completely disparate and unique stores, a concept often known to brain scientists as “repulsion.” It also indicates that the memories regarding shared environments are stored in the prefrontal cortex, not the hippocampus, which typically handles memory.

The researchers plan to apply this information to questions about diseases such as Alzheimer’s, so the next time you get turned around in a weirdly unfamiliar grocery store, just think: “It’s okay, I’m helping to solve a terrible brain disease.”
 

The real endgame: Friction is the winner

Spoiler alert! If you haven’t seen “Avengers: Infinity War” yet, we’re about to ruin it for you.

Georgia Tech

For those still with us, here’s the spoiler: Thanos would not have been able to snap his fingers while wearing the Infinity Gauntlet.

Saad Bhamla, PhD, of Georgia Tech University’s school of chemical and biomolecular engineering, had been studying powerful and ultrafast motions in living organisms along with several colleagues before the movie came out in 2018, and when they saw the finger-snapping scene it got them wondering.

Being scientists of course, they had no choice. They got out their high-speed imaging equipment, automated image processing software, and dynamic force sensors and analyzed finger snaps, paying close attention to friction by covering fingers with “different materials, including metallic thimbles to simulate the effects of trying to snap while wearing a metallic gauntlet, much like Thanos,” according to a statement on Eurekalert.

With finger snaps, it’s all about the rotational velocity. The angular acceleration involved is the fastest ever measured in a human, with a professional baseball pitcher’s throwing arm a distant second.

Dr. Bhamla’s reaction to their work explains why scientists are the ones doing science. “When I first saw the data, I jumped out of my chair,” he said in the written statement.

Rotational velocities dropped dramatically when the friction-reducing thimbles were used, so there was no snap. Which means that billions and billions of fictional lives could have been saved if the filmmakers had just talked to the right scientist.

That scientist, clearly, is Dr. Bhamla, who said that “this is the only scientific project in my lab in which we could snap our fingers and get data.”

Drinking coffee or tea is associated with reduced risk for stroke and dementia, with the biggest benefit associated with consuming both beverages, new research suggests.

amenic181/Getty Images

Investigators found that individuals who drank two to three cups of coffee and two to three cups of tea per day had a 30% decrease in incidence of stroke and a 28% lower risk for dementia compared with those who did not.

“From a public health perspective, because regular tea and coffee drinkers comprise such a large proportion of the population and because these beverages tend to be consumed habitually throughout adult life, even small potential health benefits or risks associated with tea and coffee intake may have important public health implications,” the investigators wrote.

The study was published online Nov. 16 in PLOS Medicine.
 

Synergistic effect?

Whereas earlier studies have shown significant health benefits from moderate coffee and tea intake separately, few have examined the effect of drinking both.

Researchers enrolled 365,682 participants from the UK Biobank for the analysis of coffee and tea consumption and stroke and dementia risk and 13,352 participants for the analysis of poststroke dementia.

During a median follow-up of 11.4 years, 2.8% of participants experienced a stroke and 1.4% developed dementia.

After adjustment for confounders, stroke risk was 10% lower in those who drank a half-cup to a cup of coffee per day (P < .001) and 8% lower in those who had more than two cups a day (P = .009). Tea drinkers who had more than two cups a day saw a 16% reduction in stroke (P < .001).

Those who drank both coffee and tea during the day saw the greatest benefit. Drinking two to three cups of coffee and two to three cups of tea lowered stroke risk by 32% (P < .001) and dementia risk by 28% (P = .002).

Drinking both beverages offered significantly greater benefits than drinking just coffee or tea alone, with an 11% lower risk for stroke (P < .001), an 8% lower risk for dementia (P = .001), and 18% lower risk for vascular dementia (P = .001).

Among those participants who experienced a stroke during the follow-up period, drinking two to three cups of coffee was associated with 20% lower risk for poststroke dementia (P = .044), and for those who drank both coffee and tea (half to one cup of coffee and two to three cups of tea per day) the risk for poststroke dementia was lowered by 50% (P =.006).

There was no significant association between coffee and tea consumption and risk for hemorrhagic stroke or Alzheimer’s disease.

The study was funded by the National Natural Science Foundation of China. The authors have disclosed no relevant financial relationships.

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

Drinking coffee or tea is associated with reduced risk for stroke and dementia, with the biggest benefit associated with consuming both beverages, new research suggests.

amenic181/Getty Images

Investigators found that individuals who drank two to three cups of coffee and two to three cups of tea per day had a 30% decrease in incidence of stroke and a 28% lower risk for dementia compared with those who did not.

“From a public health perspective, because regular tea and coffee drinkers comprise such a large proportion of the population and because these beverages tend to be consumed habitually throughout adult life, even small potential health benefits or risks associated with tea and coffee intake may have important public health implications,” the investigators wrote.

The study was published online Nov. 16 in PLOS Medicine.
 

Synergistic effect?

Whereas earlier studies have shown significant health benefits from moderate coffee and tea intake separately, few have examined the effect of drinking both.

Researchers enrolled 365,682 participants from the UK Biobank for the analysis of coffee and tea consumption and stroke and dementia risk and 13,352 participants for the analysis of poststroke dementia.

During a median follow-up of 11.4 years, 2.8% of participants experienced a stroke and 1.4% developed dementia.

After adjustment for confounders, stroke risk was 10% lower in those who drank a half-cup to a cup of coffee per day (P < .001) and 8% lower in those who had more than two cups a day (P = .009). Tea drinkers who had more than two cups a day saw a 16% reduction in stroke (P < .001).

Those who drank both coffee and tea during the day saw the greatest benefit. Drinking two to three cups of coffee and two to three cups of tea lowered stroke risk by 32% (P < .001) and dementia risk by 28% (P = .002).

Drinking both beverages offered significantly greater benefits than drinking just coffee or tea alone, with an 11% lower risk for stroke (P < .001), an 8% lower risk for dementia (P = .001), and 18% lower risk for vascular dementia (P = .001).

Among those participants who experienced a stroke during the follow-up period, drinking two to three cups of coffee was associated with 20% lower risk for poststroke dementia (P = .044), and for those who drank both coffee and tea (half to one cup of coffee and two to three cups of tea per day) the risk for poststroke dementia was lowered by 50% (P =.006).

There was no significant association between coffee and tea consumption and risk for hemorrhagic stroke or Alzheimer’s disease.

The study was funded by the National Natural Science Foundation of China. The authors have disclosed no relevant financial relationships.

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

Drinking coffee or tea is associated with reduced risk for stroke and dementia, with the biggest benefit associated with consuming both beverages, new research suggests.

amenic181/Getty Images

Investigators found that individuals who drank two to three cups of coffee and two to three cups of tea per day had a 30% decrease in incidence of stroke and a 28% lower risk for dementia compared with those who did not.

“From a public health perspective, because regular tea and coffee drinkers comprise such a large proportion of the population and because these beverages tend to be consumed habitually throughout adult life, even small potential health benefits or risks associated with tea and coffee intake may have important public health implications,” the investigators wrote.

The study was published online Nov. 16 in PLOS Medicine.
 

Synergistic effect?

Whereas earlier studies have shown significant health benefits from moderate coffee and tea intake separately, few have examined the effect of drinking both.

Researchers enrolled 365,682 participants from the UK Biobank for the analysis of coffee and tea consumption and stroke and dementia risk and 13,352 participants for the analysis of poststroke dementia.

During a median follow-up of 11.4 years, 2.8% of participants experienced a stroke and 1.4% developed dementia.

After adjustment for confounders, stroke risk was 10% lower in those who drank a half-cup to a cup of coffee per day (P < .001) and 8% lower in those who had more than two cups a day (P = .009). Tea drinkers who had more than two cups a day saw a 16% reduction in stroke (P < .001).

Those who drank both coffee and tea during the day saw the greatest benefit. Drinking two to three cups of coffee and two to three cups of tea lowered stroke risk by 32% (P < .001) and dementia risk by 28% (P = .002).

Drinking both beverages offered significantly greater benefits than drinking just coffee or tea alone, with an 11% lower risk for stroke (P < .001), an 8% lower risk for dementia (P = .001), and 18% lower risk for vascular dementia (P = .001).

Among those participants who experienced a stroke during the follow-up period, drinking two to three cups of coffee was associated with 20% lower risk for poststroke dementia (P = .044), and for those who drank both coffee and tea (half to one cup of coffee and two to three cups of tea per day) the risk for poststroke dementia was lowered by 50% (P =.006).

There was no significant association between coffee and tea consumption and risk for hemorrhagic stroke or Alzheimer’s disease.

The study was funded by the National Natural Science Foundation of China. The authors have disclosed no relevant financial relationships.

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

A regimen of daily, low-dose aspirin failed to produce a significant reduction in the incidence of dementia or cognitive impairment in ASCEND, a randomized, multicenter trial with more than 15,000 people with diabetes followed for an average of more than 9 years, but the results hinted at enough of a benefit to warrant further study, some experts said.

jimdeli/Fotolia

A second metric used a broader outcome definition that tracked EHR entries for not only dementia but also diagnoses of cognitive impairment, delirium, confusion, prescription of dementia medications, and referral to a memory clinic or geriatric psychiatry. The third assessment was a cognitive-function test given to participants at the end of follow-up, but only 58% of enrolled participants completed this part of the study, and it’s also possible that some subjects missed this assessment because of dementia onset. These limitations hamper clear interpretation of this third metric, Dr. Armitage said.

The main findings for the other two, more reliable measures of incident dementia or cognitive deterioration showed a nonsignificant 9% relative risk reduction linked with aspirin use compared with placebo for the more inclusive endpoint, and a nonsignificant 11% relative risk reduction with aspirin using the narrow definition for dementia only, she reported. The third method, a directly administered assessment of dementia and cognition, also showed a small, nonsignificant effect from daily aspirin use relative to placebo.

Results can’t rule out modest aspirin effect

Dr. Armitage highlighted that the two more reliable measures both appeared to rule out risk for neurologic harm from aspirin because the upper limit of the 95% confidence interval for relative effect reached only 1.02 using the broad outcomes, and 1.06 for the narrower endpoint of dementia only. On the other hand, focus on the low end of the 95% confidence interval suggested potentially meaningful benefits, with a possible reduction by aspirin in events relative to placebo of as much as 19% by the broad outcome definition and by 25% with the narrow definition.

“Even if it was only a 15% relative risk reduction, that would be important,” given the high dementia incidence worldwide, Dr. Armitage said during a press briefing. “It’s entirely possible, with our results, that a modest benefit exists.”

This take on the findings won some support. Further studies with more people, longer follow-up, and perhaps enrolling a more selected, higher risk cohort may better address potential neurologic benefit from aspirin, suggested Amytis Towfighi, MD, a stroke neurologist and professor of neurology at the University of Southern California, Los Angeles, and a designated discussant for the report.

The result “was rather encouraging. I was a little surprised” by the findings, commented Chrystie M. Ballantyne, MD, professor and director of the Center for Cardiometabolic Disease Prevention at Baylor College of Medicine, Houston, also a discussant.

The results “don’t mean that no one benefits from aspirin. Perhaps certain people at risk would benefit from dementia protection. It’s an open question,” commented Erin D. Michos, MD, director of Women’s Cardiovascular Health at Johns Hopkins Medicine, Baltimore.

Evidence against routine, widespread primary prevention with aspirin

ASCEND had the primary goal of assessing a daily, 100-mg aspirin dose for its safety and efficacy for preventing vascular events such as MIs and ischemic strokes in 15,480 people with diabetes who were at least 40 years old at enrollment and had no history of cardiovascular disease. The main results came out in 2018 and showed that while aspirin produced a significant benefit by reducing thrombotic events, it also resulted in significantly more major bleeding events compared with placebo, and overall the magnitude of benefit roughly matched magnitude of risk.

These findings, along with similar results from two other high-profile aspirin studies reported at about the same time (ASPREE, and ARRIVE), led to recommendations from groups like the U.S. Preventive Services Task Force and from the American College of Cardiology and American Heart Association that caution against widespread, routine aspirin use for primary prevention of atherosclerotic cardiovascular disease events in most adults.

The groups instead endorsed a tailored strategy of targeting aspirin to people with a higher than average risk for ischemic thrombotic events and a lower than average bleeding risk. (The most recent aspirin recommendations from the USPSTF, currently in draft form, substantially curtail aspirin’s appropriate use, eliminating it in those over age 60 years.)

However, experts and prevailing practice recommendations continue to endorse routine aspirin use for secondary prevention in patients with an established history of cardiovascular disease.

The new findings reported by Dr. Armitage came from additional analyses of dementia and cognitive impairment overlaid on the main ASCEND outcome analyses. ASCEND actively treated and followed study participants for an average of 7.4 years, then researchers tracked further dementia outcomes based on medical-record entries for an average of another 1.8 years.

ASCEND received partial funding or support from Abbott, Bayer, Mylan, and Solvay. Dr. Armitage had no disclosures. Dr. Towfighi, Dr. Khera, and Dr. Michos had no disclosures. Dr. Ballantyne has had financial relationships with numerous companies.

mzoler@mdedge.com

A regimen of daily, low-dose aspirin failed to produce a significant reduction in the incidence of dementia or cognitive impairment in ASCEND, a randomized, multicenter trial with more than 15,000 people with diabetes followed for an average of more than 9 years, but the results hinted at enough of a benefit to warrant further study, some experts said.

jimdeli/Fotolia

A second metric used a broader outcome definition that tracked EHR entries for not only dementia but also diagnoses of cognitive impairment, delirium, confusion, prescription of dementia medications, and referral to a memory clinic or geriatric psychiatry. The third assessment was a cognitive-function test given to participants at the end of follow-up, but only 58% of enrolled participants completed this part of the study, and it’s also possible that some subjects missed this assessment because of dementia onset. These limitations hamper clear interpretation of this third metric, Dr. Armitage said.

The main findings for the other two, more reliable measures of incident dementia or cognitive deterioration showed a nonsignificant 9% relative risk reduction linked with aspirin use compared with placebo for the more inclusive endpoint, and a nonsignificant 11% relative risk reduction with aspirin using the narrow definition for dementia only, she reported. The third method, a directly administered assessment of dementia and cognition, also showed a small, nonsignificant effect from daily aspirin use relative to placebo.

Results can’t rule out modest aspirin effect

Dr. Armitage highlighted that the two more reliable measures both appeared to rule out risk for neurologic harm from aspirin because the upper limit of the 95% confidence interval for relative effect reached only 1.02 using the broad outcomes, and 1.06 for the narrower endpoint of dementia only. On the other hand, focus on the low end of the 95% confidence interval suggested potentially meaningful benefits, with a possible reduction by aspirin in events relative to placebo of as much as 19% by the broad outcome definition and by 25% with the narrow definition.

“Even if it was only a 15% relative risk reduction, that would be important,” given the high dementia incidence worldwide, Dr. Armitage said during a press briefing. “It’s entirely possible, with our results, that a modest benefit exists.”

This take on the findings won some support. Further studies with more people, longer follow-up, and perhaps enrolling a more selected, higher risk cohort may better address potential neurologic benefit from aspirin, suggested Amytis Towfighi, MD, a stroke neurologist and professor of neurology at the University of Southern California, Los Angeles, and a designated discussant for the report.

The result “was rather encouraging. I was a little surprised” by the findings, commented Chrystie M. Ballantyne, MD, professor and director of the Center for Cardiometabolic Disease Prevention at Baylor College of Medicine, Houston, also a discussant.

The results “don’t mean that no one benefits from aspirin. Perhaps certain people at risk would benefit from dementia protection. It’s an open question,” commented Erin D. Michos, MD, director of Women’s Cardiovascular Health at Johns Hopkins Medicine, Baltimore.

Evidence against routine, widespread primary prevention with aspirin

ASCEND had the primary goal of assessing a daily, 100-mg aspirin dose for its safety and efficacy for preventing vascular events such as MIs and ischemic strokes in 15,480 people with diabetes who were at least 40 years old at enrollment and had no history of cardiovascular disease. The main results came out in 2018 and showed that while aspirin produced a significant benefit by reducing thrombotic events, it also resulted in significantly more major bleeding events compared with placebo, and overall the magnitude of benefit roughly matched magnitude of risk.

These findings, along with similar results from two other high-profile aspirin studies reported at about the same time (ASPREE, and ARRIVE), led to recommendations from groups like the U.S. Preventive Services Task Force and from the American College of Cardiology and American Heart Association that caution against widespread, routine aspirin use for primary prevention of atherosclerotic cardiovascular disease events in most adults.

The groups instead endorsed a tailored strategy of targeting aspirin to people with a higher than average risk for ischemic thrombotic events and a lower than average bleeding risk. (The most recent aspirin recommendations from the USPSTF, currently in draft form, substantially curtail aspirin’s appropriate use, eliminating it in those over age 60 years.)

However, experts and prevailing practice recommendations continue to endorse routine aspirin use for secondary prevention in patients with an established history of cardiovascular disease.

The new findings reported by Dr. Armitage came from additional analyses of dementia and cognitive impairment overlaid on the main ASCEND outcome analyses. ASCEND actively treated and followed study participants for an average of 7.4 years, then researchers tracked further dementia outcomes based on medical-record entries for an average of another 1.8 years.

ASCEND received partial funding or support from Abbott, Bayer, Mylan, and Solvay. Dr. Armitage had no disclosures. Dr. Towfighi, Dr. Khera, and Dr. Michos had no disclosures. Dr. Ballantyne has had financial relationships with numerous companies.

mzoler@mdedge.com

A regimen of daily, low-dose aspirin failed to produce a significant reduction in the incidence of dementia or cognitive impairment in ASCEND, a randomized, multicenter trial with more than 15,000 people with diabetes followed for an average of more than 9 years, but the results hinted at enough of a benefit to warrant further study, some experts said.

jimdeli/Fotolia

A second metric used a broader outcome definition that tracked EHR entries for not only dementia but also diagnoses of cognitive impairment, delirium, confusion, prescription of dementia medications, and referral to a memory clinic or geriatric psychiatry. The third assessment was a cognitive-function test given to participants at the end of follow-up, but only 58% of enrolled participants completed this part of the study, and it’s also possible that some subjects missed this assessment because of dementia onset. These limitations hamper clear interpretation of this third metric, Dr. Armitage said.

The main findings for the other two, more reliable measures of incident dementia or cognitive deterioration showed a nonsignificant 9% relative risk reduction linked with aspirin use compared with placebo for the more inclusive endpoint, and a nonsignificant 11% relative risk reduction with aspirin using the narrow definition for dementia only, she reported. The third method, a directly administered assessment of dementia and cognition, also showed a small, nonsignificant effect from daily aspirin use relative to placebo.

Results can’t rule out modest aspirin effect

Dr. Armitage highlighted that the two more reliable measures both appeared to rule out risk for neurologic harm from aspirin because the upper limit of the 95% confidence interval for relative effect reached only 1.02 using the broad outcomes, and 1.06 for the narrower endpoint of dementia only. On the other hand, focus on the low end of the 95% confidence interval suggested potentially meaningful benefits, with a possible reduction by aspirin in events relative to placebo of as much as 19% by the broad outcome definition and by 25% with the narrow definition.

“Even if it was only a 15% relative risk reduction, that would be important,” given the high dementia incidence worldwide, Dr. Armitage said during a press briefing. “It’s entirely possible, with our results, that a modest benefit exists.”

This take on the findings won some support. Further studies with more people, longer follow-up, and perhaps enrolling a more selected, higher risk cohort may better address potential neurologic benefit from aspirin, suggested Amytis Towfighi, MD, a stroke neurologist and professor of neurology at the University of Southern California, Los Angeles, and a designated discussant for the report.

The result “was rather encouraging. I was a little surprised” by the findings, commented Chrystie M. Ballantyne, MD, professor and director of the Center for Cardiometabolic Disease Prevention at Baylor College of Medicine, Houston, also a discussant.

The results “don’t mean that no one benefits from aspirin. Perhaps certain people at risk would benefit from dementia protection. It’s an open question,” commented Erin D. Michos, MD, director of Women’s Cardiovascular Health at Johns Hopkins Medicine, Baltimore.

Evidence against routine, widespread primary prevention with aspirin

ASCEND had the primary goal of assessing a daily, 100-mg aspirin dose for its safety and efficacy for preventing vascular events such as MIs and ischemic strokes in 15,480 people with diabetes who were at least 40 years old at enrollment and had no history of cardiovascular disease. The main results came out in 2018 and showed that while aspirin produced a significant benefit by reducing thrombotic events, it also resulted in significantly more major bleeding events compared with placebo, and overall the magnitude of benefit roughly matched magnitude of risk.

These findings, along with similar results from two other high-profile aspirin studies reported at about the same time (ASPREE, and ARRIVE), led to recommendations from groups like the U.S. Preventive Services Task Force and from the American College of Cardiology and American Heart Association that caution against widespread, routine aspirin use for primary prevention of atherosclerotic cardiovascular disease events in most adults.

The groups instead endorsed a tailored strategy of targeting aspirin to people with a higher than average risk for ischemic thrombotic events and a lower than average bleeding risk. (The most recent aspirin recommendations from the USPSTF, currently in draft form, substantially curtail aspirin’s appropriate use, eliminating it in those over age 60 years.)

However, experts and prevailing practice recommendations continue to endorse routine aspirin use for secondary prevention in patients with an established history of cardiovascular disease.

The new findings reported by Dr. Armitage came from additional analyses of dementia and cognitive impairment overlaid on the main ASCEND outcome analyses. ASCEND actively treated and followed study participants for an average of 7.4 years, then researchers tracked further dementia outcomes based on medical-record entries for an average of another 1.8 years.

ASCEND received partial funding or support from Abbott, Bayer, Mylan, and Solvay. Dr. Armitage had no disclosures. Dr. Towfighi, Dr. Khera, and Dr. Michos had no disclosures. Dr. Ballantyne has had financial relationships with numerous companies.

mzoler@mdedge.com

If you are a psychiatrist who has done a public lecture in the past year, you likely encountered the question, “What about Britney’s conservatorship?” Many psychiatrists are far removed from conservatorship evaluations, doing the different yet still important work of alleviating mental suffering without paddling in the controversial waters of involuntary treatment. Others judiciously hide behind the veil of the prudent Goldwater Rule in avoiding such discussions altogether. Regardless of whether psychiatry attempts to stay out of such affairs publicly, our field remains intimately involved in the process itself. This can lead to negative views of psychiatry among the public – that of a medical specialty with ulterior motives operating at the behest of the state.

Some psychiatrists simplistically advocate against any form of involuntary treatment.¹ In many ways, this may appear noble. However, the reality of mental illness, with its potential harm to self and others, introduces the potential for dire consequences of such a position. If society is unwilling to accept behavior that may lead to harm, but psychiatry is unwilling to intervene, then other avenues of restricting such behavior will emerge. Those avenues traditionally have included conscription of law enforcement and the incarceration of patients with mental illness.

Yet, therein lies the conundrum of Ms. Spears and other celebrities on conservatorship. At face value, they do not appear to require conservatorship. We do not think it violates the Goldwater Rule to render this observation. In fact, it may reassure the public if the American Psychiatric Association, as well as individual psychiatrists, were more open about the goal, intent, and limitations of conservatorships.

The process of establishing conservatorships is not driven solely by mental health professionals. Rather, conservatorship laws permit society to enact, through psychiatrists, its desire to alleviate behaviors considered unacceptable in the context of mental illness.

In California, it has resulted in our famous or infamous “5150,” which asks psychiatrists to comment on the danger to self, danger to others, and grave disability of our patients. It can be helpful to frame these criteria regarding the relationship between society and our patients. The criteria of danger to self represents society’s wish to intervene in cases of patients with imminent intent of self-harm, operating under the presumption that a suicide can be prevented. Danger to others represents the societal angst, at times exaggerated,² about people with mental illness perpetuating homicides, especially when off their medication. Grave disability represents public shame at the thought of persons so lost to mental illness they are unable to provide for themselves or even accept food, clothing, and shelter.

While an involuntary hold is necessary at times, working against our patients engenders revolting feelings. We often rationalize involuntary holds as illustrative of sincere compassion for our patients’ suffering and an attempt to lift them out of such tragic conditions. Our patients regularly do not feel our compassion when we are making an argument in a hearing for the restriction of their rights. They see our efforts as an attempt to lock them away “for their own good” because of society’s discomfort with homelessness. As such, we wonder whether our role becomes one of doctors for society, prescribing a treatment for the emotional distress of the community, and at times for ourselves, rather than that of the patient.

One may be perplexed as to how a celebrity could be considered gravely disabled. Celebrities generally have enough income to afford food, clothing, and shelter. One could justifiably ask why an individual with no history of violence would be considered a danger to others. Similarly, one may wonder how, in the absence of any reported attempts to engage in self-harm, with no visible marks of self-harm, someone is determined to be a danger to himself or herself. The bafflement on the part of one on the outside of these determinations can be sharply contrasted by the desperation felt by family members whose loved ones with mental illness appear to meet those criteria yet are consistently turned away by mental health programs and hospitals.

Not uncommonly, it is families advocating for involuntary hospitalization – while lamenting our strict criteria – that prevent doctors from intervening until some tragic fate befalls their loved ones. They criticize what they consider to be too-stringent mental health laws and are infuriated by seemingly obtuse insurance policies limiting care to patients. Most of our colleagues working with those who have severe mental illness share the frustration of these families over the scarcity of psychiatry beds. Therefore, it is particularly shocking when the most mediatized story about conservatorship is not about how hard it is to obtain. The story is about a singer who was seemingly safe, caring for herself, and yet still ended up on a conservatorship.

We wonder whether there is a question of magnitude. Are homeless patients more difficult to place on conservatorship because society sees a lesser stake? One could argue that Ms. Spears and other celebrities would have so much to lose in a single episode of mental illness. A week with mania or psychosis could cause irreparable damage to their persona, opportunity for employment, and their fortune. On the contrary, many of our patients on conservatorship have little to their names, and no one keeping up on their reputation. Triers of facts should ask themselves about the nature of their motivations. Envy, a desire to live vicariously through celebrities, or even less ethical motivations – such as a desire to control and exert authority over those individuals – can influence our decisions.

Throughout the past year, when asked about Ms. Spears, we have pointed out the obvious – she seemingly has a life incompatible with meeting criteria for a psychiatric conservatorship. We have outlined the role, history, and limitations of psychiatric conservatorship. We have shared how such cases are often approached, when required for our own patients or when asked by the court to do so. We have discussed the significant oversight of the system, including the public conservator’s office, which frequently refuses petitions outright. There are hearing officers, who, in the early stages of this process, weigh our case against that of the patients, aided by passionately driven patient advocates. There is the public defender’s office, which, at least in San Diego, vigorously defends the rights of those with mental illness. Most importantly, there are judges who adjudicate those cases with diligence and humility.

As the story has continued to be in the news, we have had numerous conversations about Ms. Spears’ conservatorship with colleagues sharing strong opinions on her case. Many of these colleagues do not have forensic practices and we inevitably find ourselves responding along the lines of, “It is easy to say this, but quite a different thing to prove it in court.” It is hard not to imagine testifying in such a high-profile conservatorship case; testifying, in front of jurors, about a celebrity who may have engaged in what some considered to be unusual behavior.

Conservatorship laws are not about the minutia or criteria of a specific mental health disorder. Patients do not meet criteria for conservatorship by having a certain number of delusional thoughts or a specific type of hallucination. Patients meet criteria for conservatorship because of state-enacted laws based on social factors – such as danger and self-care – the population wishes to treat, even if against the will of those treated. Under this light, one must recognize that a conservatorship trial is not just about mental illness but about how society wants to care for human beings. Psychiatric illness itself is not grounds for conservatorship. Oftentimes, severely ill patients win a hearing for grave disability by simply accepting a referral for housing, showing up to court clothed, and eating the meals provided at the hospital.

With understanding that these laws pertain specifically to behaviors resulting from mental illness that society finds unacceptable, the narrative of a celebrity conservatorship can be considered differently. The stories of celebrities being used and abused by deleterious beings and deleterious conditions have become a genre. Paul Prenter’s treatment of Freddie Mercury documented in the 2018 movie “Bohemian Rhapsody” and John Reid’s alleged betrayal of Elton John, who was suffering from a substance use disorder, documented in the 2019 movie “Rocketman,” are recent examples, among many.

Imagine yourself, as a juror, deciding on the fate of a celebrity. Would you require them to have lost all property, including the clothing on their backs, before intervening? Consider the next time you hear of a celebrity swindled from his or her fortune in a time of crisis and whether it would have been righteous to prevent it. We personally have, at times, argued for restraint in psychiatry’s desire to have more power. This concern extends not only to our ability to control people, but also our ability to force them into being subjected to psychotropic medications with well-known side effects.

At the same time, we remain cognizant of the magnified impact of adverse outcomes on public figures. John Hinckley Jr. did not attempt to murder a bystander; he attempted to kill the president of the United States when he shot at President Ronald Reagan in 1981. That incident led to considerable changes in our laws about insanity. More recently, society was particularly affected by Tom Hanks’ COVID-19 diagnosis. Mr. Hanks’ illness led to scientifically measurable changes in the public’s beliefs regarding the pandemic.³

On the other hand, and of equal importance to the desire to protect public figures from adverse events, is the risk that those same laws intended to protect will harm. From unsanitary asylums to disproportionate placements of minorities on psychiatric holds, we are concerned with unbridled control in the hands of those meant to cure and care. Sadly, there is also a cinematic genre of unprincipled and detrimental mental health treatment, from Brian Wilson’s treatment by his psychologist documented in “Love & Mercy,” to the upcoming “The Shrink Next Door,” featuring a psychiatrist swindling his patient.

With this additional understanding and analysis, we now ask our colleagues what it would take for them to intervene. Would a celebrity losing $100,000,000 because of mental illness constitute a form of grave disability despite remaining dressed? Would a celebrity engaging in significant drug use constitute a form of self-harm despite still recording albums? Would a celebrity failing to fulfill a social commitment to others, including children, constitute a form of harm to others? Those are not trivial questions to answer, and we are glad the Goldwater Rule reminds us of the limitations of speculating on people we do not know.

Nonetheless, the question of conservatorship is more complex than simply saying: “They make money; they have clothes on; this is absurd.” While this may be a catchy, compelling, and relevant argument, when confronted with a more complete narrative, triers of facts may feel compelled to intervene because, in the end, conservatorship laws are about what society is willing to accept rather than an enumeration of psychiatric symptoms.

Dr. Badre is a clinical and forensic psychiatrist in San Diego. He holds teaching positions at the University of California, San Diego, and the University of San Diego. He teaches medical education, psychopharmacology, ethics in psychiatry, and correctional care. Dr. Badre can be reached at his website, BadreMD.com. Dr. Compton is a psychiatry resident at University of California, San Diego. His background includes medical education, mental health advocacy, work with underserved populations, and brain cancer research.

References

1. Badre N et al. “Coercion and the critical psychiatrist.” In Critical Psychiatry. Springer, Cham, 2019. doi: 10.1007/97-3-030-02732-2_7.

2. Barnes SS and Badre N. Psychiatr Serv. 2016 Jul 1;67(7)784-6.

3. Myrick JG and Willoughby JF. Health Commun. 2021 Jan 14;1-9.

If you are a psychiatrist who has done a public lecture in the past year, you likely encountered the question, “What about Britney’s conservatorship?” Many psychiatrists are far removed from conservatorship evaluations, doing the different yet still important work of alleviating mental suffering without paddling in the controversial waters of involuntary treatment. Others judiciously hide behind the veil of the prudent Goldwater Rule in avoiding such discussions altogether. Regardless of whether psychiatry attempts to stay out of such affairs publicly, our field remains intimately involved in the process itself. This can lead to negative views of psychiatry among the public – that of a medical specialty with ulterior motives operating at the behest of the state.

Some psychiatrists simplistically advocate against any form of involuntary treatment.¹ In many ways, this may appear noble. However, the reality of mental illness, with its potential harm to self and others, introduces the potential for dire consequences of such a position. If society is unwilling to accept behavior that may lead to harm, but psychiatry is unwilling to intervene, then other avenues of restricting such behavior will emerge. Those avenues traditionally have included conscription of law enforcement and the incarceration of patients with mental illness.

Yet, therein lies the conundrum of Ms. Spears and other celebrities on conservatorship. At face value, they do not appear to require conservatorship. We do not think it violates the Goldwater Rule to render this observation. In fact, it may reassure the public if the American Psychiatric Association, as well as individual psychiatrists, were more open about the goal, intent, and limitations of conservatorships.

The process of establishing conservatorships is not driven solely by mental health professionals. Rather, conservatorship laws permit society to enact, through psychiatrists, its desire to alleviate behaviors considered unacceptable in the context of mental illness.

In California, it has resulted in our famous or infamous “5150,” which asks psychiatrists to comment on the danger to self, danger to others, and grave disability of our patients. It can be helpful to frame these criteria regarding the relationship between society and our patients. The criteria of danger to self represents society’s wish to intervene in cases of patients with imminent intent of self-harm, operating under the presumption that a suicide can be prevented. Danger to others represents the societal angst, at times exaggerated,² about people with mental illness perpetuating homicides, especially when off their medication. Grave disability represents public shame at the thought of persons so lost to mental illness they are unable to provide for themselves or even accept food, clothing, and shelter.

While an involuntary hold is necessary at times, working against our patients engenders revolting feelings. We often rationalize involuntary holds as illustrative of sincere compassion for our patients’ suffering and an attempt to lift them out of such tragic conditions. Our patients regularly do not feel our compassion when we are making an argument in a hearing for the restriction of their rights. They see our efforts as an attempt to lock them away “for their own good” because of society’s discomfort with homelessness. As such, we wonder whether our role becomes one of doctors for society, prescribing a treatment for the emotional distress of the community, and at times for ourselves, rather than that of the patient.

One may be perplexed as to how a celebrity could be considered gravely disabled. Celebrities generally have enough income to afford food, clothing, and shelter. One could justifiably ask why an individual with no history of violence would be considered a danger to others. Similarly, one may wonder how, in the absence of any reported attempts to engage in self-harm, with no visible marks of self-harm, someone is determined to be a danger to himself or herself. The bafflement on the part of one on the outside of these determinations can be sharply contrasted by the desperation felt by family members whose loved ones with mental illness appear to meet those criteria yet are consistently turned away by mental health programs and hospitals.

Not uncommonly, it is families advocating for involuntary hospitalization – while lamenting our strict criteria – that prevent doctors from intervening until some tragic fate befalls their loved ones. They criticize what they consider to be too-stringent mental health laws and are infuriated by seemingly obtuse insurance policies limiting care to patients. Most of our colleagues working with those who have severe mental illness share the frustration of these families over the scarcity of psychiatry beds. Therefore, it is particularly shocking when the most mediatized story about conservatorship is not about how hard it is to obtain. The story is about a singer who was seemingly safe, caring for herself, and yet still ended up on a conservatorship.

We wonder whether there is a question of magnitude. Are homeless patients more difficult to place on conservatorship because society sees a lesser stake? One could argue that Ms. Spears and other celebrities would have so much to lose in a single episode of mental illness. A week with mania or psychosis could cause irreparable damage to their persona, opportunity for employment, and their fortune. On the contrary, many of our patients on conservatorship have little to their names, and no one keeping up on their reputation. Triers of facts should ask themselves about the nature of their motivations. Envy, a desire to live vicariously through celebrities, or even less ethical motivations – such as a desire to control and exert authority over those individuals – can influence our decisions.

Throughout the past year, when asked about Ms. Spears, we have pointed out the obvious – she seemingly has a life incompatible with meeting criteria for a psychiatric conservatorship. We have outlined the role, history, and limitations of psychiatric conservatorship. We have shared how such cases are often approached, when required for our own patients or when asked by the court to do so. We have discussed the significant oversight of the system, including the public conservator’s office, which frequently refuses petitions outright. There are hearing officers, who, in the early stages of this process, weigh our case against that of the patients, aided by passionately driven patient advocates. There is the public defender’s office, which, at least in San Diego, vigorously defends the rights of those with mental illness. Most importantly, there are judges who adjudicate those cases with diligence and humility.

As the story has continued to be in the news, we have had numerous conversations about Ms. Spears’ conservatorship with colleagues sharing strong opinions on her case. Many of these colleagues do not have forensic practices and we inevitably find ourselves responding along the lines of, “It is easy to say this, but quite a different thing to prove it in court.” It is hard not to imagine testifying in such a high-profile conservatorship case; testifying, in front of jurors, about a celebrity who may have engaged in what some considered to be unusual behavior.

Conservatorship laws are not about the minutia or criteria of a specific mental health disorder. Patients do not meet criteria for conservatorship by having a certain number of delusional thoughts or a specific type of hallucination. Patients meet criteria for conservatorship because of state-enacted laws based on social factors – such as danger and self-care – the population wishes to treat, even if against the will of those treated. Under this light, one must recognize that a conservatorship trial is not just about mental illness but about how society wants to care for human beings. Psychiatric illness itself is not grounds for conservatorship. Oftentimes, severely ill patients win a hearing for grave disability by simply accepting a referral for housing, showing up to court clothed, and eating the meals provided at the hospital.

With understanding that these laws pertain specifically to behaviors resulting from mental illness that society finds unacceptable, the narrative of a celebrity conservatorship can be considered differently. The stories of celebrities being used and abused by deleterious beings and deleterious conditions have become a genre. Paul Prenter’s treatment of Freddie Mercury documented in the 2018 movie “Bohemian Rhapsody” and John Reid’s alleged betrayal of Elton John, who was suffering from a substance use disorder, documented in the 2019 movie “Rocketman,” are recent examples, among many.

Imagine yourself, as a juror, deciding on the fate of a celebrity. Would you require them to have lost all property, including the clothing on their backs, before intervening? Consider the next time you hear of a celebrity swindled from his or her fortune in a time of crisis and whether it would have been righteous to prevent it. We personally have, at times, argued for restraint in psychiatry’s desire to have more power. This concern extends not only to our ability to control people, but also our ability to force them into being subjected to psychotropic medications with well-known side effects.

At the same time, we remain cognizant of the magnified impact of adverse outcomes on public figures. John Hinckley Jr. did not attempt to murder a bystander; he attempted to kill the president of the United States when he shot at President Ronald Reagan in 1981. That incident led to considerable changes in our laws about insanity. More recently, society was particularly affected by Tom Hanks’ COVID-19 diagnosis. Mr. Hanks’ illness led to scientifically measurable changes in the public’s beliefs regarding the pandemic.³

On the other hand, and of equal importance to the desire to protect public figures from adverse events, is the risk that those same laws intended to protect will harm. From unsanitary asylums to disproportionate placements of minorities on psychiatric holds, we are concerned with unbridled control in the hands of those meant to cure and care. Sadly, there is also a cinematic genre of unprincipled and detrimental mental health treatment, from Brian Wilson’s treatment by his psychologist documented in “Love & Mercy,” to the upcoming “The Shrink Next Door,” featuring a psychiatrist swindling his patient.

With this additional understanding and analysis, we now ask our colleagues what it would take for them to intervene. Would a celebrity losing $100,000,000 because of mental illness constitute a form of grave disability despite remaining dressed? Would a celebrity engaging in significant drug use constitute a form of self-harm despite still recording albums? Would a celebrity failing to fulfill a social commitment to others, including children, constitute a form of harm to others? Those are not trivial questions to answer, and we are glad the Goldwater Rule reminds us of the limitations of speculating on people we do not know.

Nonetheless, the question of conservatorship is more complex than simply saying: “They make money; they have clothes on; this is absurd.” While this may be a catchy, compelling, and relevant argument, when confronted with a more complete narrative, triers of facts may feel compelled to intervene because, in the end, conservatorship laws are about what society is willing to accept rather than an enumeration of psychiatric symptoms.

Dr. Badre is a clinical and forensic psychiatrist in San Diego. He holds teaching positions at the University of California, San Diego, and the University of San Diego. He teaches medical education, psychopharmacology, ethics in psychiatry, and correctional care. Dr. Badre can be reached at his website, BadreMD.com. Dr. Compton is a psychiatry resident at University of California, San Diego. His background includes medical education, mental health advocacy, work with underserved populations, and brain cancer research.

References

1. Badre N et al. “Coercion and the critical psychiatrist.” In Critical Psychiatry. Springer, Cham, 2019. doi: 10.1007/97-3-030-02732-2_7.

2. Barnes SS and Badre N. Psychiatr Serv. 2016 Jul 1;67(7)784-6.

3. Myrick JG and Willoughby JF. Health Commun. 2021 Jan 14;1-9.

If you are a psychiatrist who has done a public lecture in the past year, you likely encountered the question, “What about Britney’s conservatorship?” Many psychiatrists are far removed from conservatorship evaluations, doing the different yet still important work of alleviating mental suffering without paddling in the controversial waters of involuntary treatment. Others judiciously hide behind the veil of the prudent Goldwater Rule in avoiding such discussions altogether. Regardless of whether psychiatry attempts to stay out of such affairs publicly, our field remains intimately involved in the process itself. This can lead to negative views of psychiatry among the public – that of a medical specialty with ulterior motives operating at the behest of the state.

Some psychiatrists simplistically advocate against any form of involuntary treatment.¹ In many ways, this may appear noble. However, the reality of mental illness, with its potential harm to self and others, introduces the potential for dire consequences of such a position. If society is unwilling to accept behavior that may lead to harm, but psychiatry is unwilling to intervene, then other avenues of restricting such behavior will emerge. Those avenues traditionally have included conscription of law enforcement and the incarceration of patients with mental illness.

Yet, therein lies the conundrum of Ms. Spears and other celebrities on conservatorship. At face value, they do not appear to require conservatorship. We do not think it violates the Goldwater Rule to render this observation. In fact, it may reassure the public if the American Psychiatric Association, as well as individual psychiatrists, were more open about the goal, intent, and limitations of conservatorships.

The process of establishing conservatorships is not driven solely by mental health professionals. Rather, conservatorship laws permit society to enact, through psychiatrists, its desire to alleviate behaviors considered unacceptable in the context of mental illness.

In California, it has resulted in our famous or infamous “5150,” which asks psychiatrists to comment on the danger to self, danger to others, and grave disability of our patients. It can be helpful to frame these criteria regarding the relationship between society and our patients. The criteria of danger to self represents society’s wish to intervene in cases of patients with imminent intent of self-harm, operating under the presumption that a suicide can be prevented. Danger to others represents the societal angst, at times exaggerated,² about people with mental illness perpetuating homicides, especially when off their medication. Grave disability represents public shame at the thought of persons so lost to mental illness they are unable to provide for themselves or even accept food, clothing, and shelter.

While an involuntary hold is necessary at times, working against our patients engenders revolting feelings. We often rationalize involuntary holds as illustrative of sincere compassion for our patients’ suffering and an attempt to lift them out of such tragic conditions. Our patients regularly do not feel our compassion when we are making an argument in a hearing for the restriction of their rights. They see our efforts as an attempt to lock them away “for their own good” because of society’s discomfort with homelessness. As such, we wonder whether our role becomes one of doctors for society, prescribing a treatment for the emotional distress of the community, and at times for ourselves, rather than that of the patient.

One may be perplexed as to how a celebrity could be considered gravely disabled. Celebrities generally have enough income to afford food, clothing, and shelter. One could justifiably ask why an individual with no history of violence would be considered a danger to others. Similarly, one may wonder how, in the absence of any reported attempts to engage in self-harm, with no visible marks of self-harm, someone is determined to be a danger to himself or herself. The bafflement on the part of one on the outside of these determinations can be sharply contrasted by the desperation felt by family members whose loved ones with mental illness appear to meet those criteria yet are consistently turned away by mental health programs and hospitals.

Not uncommonly, it is families advocating for involuntary hospitalization – while lamenting our strict criteria – that prevent doctors from intervening until some tragic fate befalls their loved ones. They criticize what they consider to be too-stringent mental health laws and are infuriated by seemingly obtuse insurance policies limiting care to patients. Most of our colleagues working with those who have severe mental illness share the frustration of these families over the scarcity of psychiatry beds. Therefore, it is particularly shocking when the most mediatized story about conservatorship is not about how hard it is to obtain. The story is about a singer who was seemingly safe, caring for herself, and yet still ended up on a conservatorship.

We wonder whether there is a question of magnitude. Are homeless patients more difficult to place on conservatorship because society sees a lesser stake? One could argue that Ms. Spears and other celebrities would have so much to lose in a single episode of mental illness. A week with mania or psychosis could cause irreparable damage to their persona, opportunity for employment, and their fortune. On the contrary, many of our patients on conservatorship have little to their names, and no one keeping up on their reputation. Triers of facts should ask themselves about the nature of their motivations. Envy, a desire to live vicariously through celebrities, or even less ethical motivations – such as a desire to control and exert authority over those individuals – can influence our decisions.

Throughout the past year, when asked about Ms. Spears, we have pointed out the obvious – she seemingly has a life incompatible with meeting criteria for a psychiatric conservatorship. We have outlined the role, history, and limitations of psychiatric conservatorship. We have shared how such cases are often approached, when required for our own patients or when asked by the court to do so. We have discussed the significant oversight of the system, including the public conservator’s office, which frequently refuses petitions outright. There are hearing officers, who, in the early stages of this process, weigh our case against that of the patients, aided by passionately driven patient advocates. There is the public defender’s office, which, at least in San Diego, vigorously defends the rights of those with mental illness. Most importantly, there are judges who adjudicate those cases with diligence and humility.

As the story has continued to be in the news, we have had numerous conversations about Ms. Spears’ conservatorship with colleagues sharing strong opinions on her case. Many of these colleagues do not have forensic practices and we inevitably find ourselves responding along the lines of, “It is easy to say this, but quite a different thing to prove it in court.” It is hard not to imagine testifying in such a high-profile conservatorship case; testifying, in front of jurors, about a celebrity who may have engaged in what some considered to be unusual behavior.

Conservatorship laws are not about the minutia or criteria of a specific mental health disorder. Patients do not meet criteria for conservatorship by having a certain number of delusional thoughts or a specific type of hallucination. Patients meet criteria for conservatorship because of state-enacted laws based on social factors – such as danger and self-care – the population wishes to treat, even if against the will of those treated. Under this light, one must recognize that a conservatorship trial is not just about mental illness but about how society wants to care for human beings. Psychiatric illness itself is not grounds for conservatorship. Oftentimes, severely ill patients win a hearing for grave disability by simply accepting a referral for housing, showing up to court clothed, and eating the meals provided at the hospital.

With understanding that these laws pertain specifically to behaviors resulting from mental illness that society finds unacceptable, the narrative of a celebrity conservatorship can be considered differently. The stories of celebrities being used and abused by deleterious beings and deleterious conditions have become a genre. Paul Prenter’s treatment of Freddie Mercury documented in the 2018 movie “Bohemian Rhapsody” and John Reid’s alleged betrayal of Elton John, who was suffering from a substance use disorder, documented in the 2019 movie “Rocketman,” are recent examples, among many.

Imagine yourself, as a juror, deciding on the fate of a celebrity. Would you require them to have lost all property, including the clothing on their backs, before intervening? Consider the next time you hear of a celebrity swindled from his or her fortune in a time of crisis and whether it would have been righteous to prevent it. We personally have, at times, argued for restraint in psychiatry’s desire to have more power. This concern extends not only to our ability to control people, but also our ability to force them into being subjected to psychotropic medications with well-known side effects.

At the same time, we remain cognizant of the magnified impact of adverse outcomes on public figures. John Hinckley Jr. did not attempt to murder a bystander; he attempted to kill the president of the United States when he shot at President Ronald Reagan in 1981. That incident led to considerable changes in our laws about insanity. More recently, society was particularly affected by Tom Hanks’ COVID-19 diagnosis. Mr. Hanks’ illness led to scientifically measurable changes in the public’s beliefs regarding the pandemic.³

On the other hand, and of equal importance to the desire to protect public figures from adverse events, is the risk that those same laws intended to protect will harm. From unsanitary asylums to disproportionate placements of minorities on psychiatric holds, we are concerned with unbridled control in the hands of those meant to cure and care. Sadly, there is also a cinematic genre of unprincipled and detrimental mental health treatment, from Brian Wilson’s treatment by his psychologist documented in “Love & Mercy,” to the upcoming “The Shrink Next Door,” featuring a psychiatrist swindling his patient.

With this additional understanding and analysis, we now ask our colleagues what it would take for them to intervene. Would a celebrity losing $100,000,000 because of mental illness constitute a form of grave disability despite remaining dressed? Would a celebrity engaging in significant drug use constitute a form of self-harm despite still recording albums? Would a celebrity failing to fulfill a social commitment to others, including children, constitute a form of harm to others? Those are not trivial questions to answer, and we are glad the Goldwater Rule reminds us of the limitations of speculating on people we do not know.

Nonetheless, the question of conservatorship is more complex than simply saying: “They make money; they have clothes on; this is absurd.” While this may be a catchy, compelling, and relevant argument, when confronted with a more complete narrative, triers of facts may feel compelled to intervene because, in the end, conservatorship laws are about what society is willing to accept rather than an enumeration of psychiatric symptoms.

Dr. Badre is a clinical and forensic psychiatrist in San Diego. He holds teaching positions at the University of California, San Diego, and the University of San Diego. He teaches medical education, psychopharmacology, ethics in psychiatry, and correctional care. Dr. Badre can be reached at his website, BadreMD.com. Dr. Compton is a psychiatry resident at University of California, San Diego. His background includes medical education, mental health advocacy, work with underserved populations, and brain cancer research.

References

1. Badre N et al. “Coercion and the critical psychiatrist.” In Critical Psychiatry. Springer, Cham, 2019. doi: 10.1007/97-3-030-02732-2_7.

2. Barnes SS and Badre N. Psychiatr Serv. 2016 Jul 1;67(7)784-6.

3. Myrick JG and Willoughby JF. Health Commun. 2021 Jan 14;1-9.

A majority of healthy preschoolers were able to recognize emotions shown in static pictures of adults with and without face masks, based on data from a cross-sectional study of 276 children.

Some are concerned about the effects of adults working in preschools wearing face masks on the ability of young children to learn to recognize emotions, study author Juliane Schneider, MD, of University Hospital Lausanne (Switzerland), and colleagues wrote. Previous studies using photographs of faces with digitally added masks have suggested that young children’s emotional recognition was worse with masked faces.

In the study published in JAMA Pediatrics, the researchers tested the impact of masks on the ability of preschool children to identify joy, anger, and sadness. The study included 135 girls and 141 boys aged 36-72 months with a mean age of 52.4 months. The tests were conducted at nine daycare centers.

Children were shown photographs of 15 actors (5 men and 10 women) with and without surgical face masks. The total data set included 90 pictures illustrating joy, anger, and sadness. The children were shown the pictures at random, and they could either name the emotion, point to a card with emoticons showing the three emotions, or respond “I don’t know” or “quit the experiment.” Test sessions lasted approximately 7 minutes per child. Effect sizes were calculated using X² and Cramer V tests.

Overall, 68.8% of the children correctly identified the emotion portrayed; the correct response rate was 70.6% for faces without face masks and 66.9% for those with face masks. Correct recognition of joy was significantly higher for faces without masks than for those with masks (94.8% vs. 87.3), as was correct recognition of sadness (54.1% vs. 48.9%; P < .001 for both). Recognition of anger was not significantly different for unmasked and masked faces (62.2% vs. 64.6%, P = .10).

No significant differences in correct responses appeared between boys and girls and the rate of correct responses increased significantly with age. The rates of “I don’t know,” and “quit the experiment” responses were 3.1% and 2.2%, respectively. In an analysis of incorrect responses, approximately 25% of the children confused anger and sadness, and 21% misidentified joy for images of anger or sadness.

“Overall, participants in this study, who had been exposed to face masks for nearly a year, recognized emotions on pictures better than has been reported in previous research, even with face masks,” the researchers wrote.

The study findings were limited by several factors including the use of static pictures versus real individuals, which limits generalizability, and the lack of data on children with developmental issues, the researchers noted.

Despite relatively small differences and weak effect size (Cramer V scores of 0.2 or less for all), the results show a stronger recognition of emotion, compared with other studies, and highlight the importance of investigating the impact of face masks on other aspects of child development as the COVID-19 pandemic persists, the researchers concluded.

The study received no outside funding. The researchers had no relevant financial conflicts to disclose.

A majority of healthy preschoolers were able to recognize emotions shown in static pictures of adults with and without face masks, based on data from a cross-sectional study of 276 children.

Some are concerned about the effects of adults working in preschools wearing face masks on the ability of young children to learn to recognize emotions, study author Juliane Schneider, MD, of University Hospital Lausanne (Switzerland), and colleagues wrote. Previous studies using photographs of faces with digitally added masks have suggested that young children’s emotional recognition was worse with masked faces.

In the study published in JAMA Pediatrics, the researchers tested the impact of masks on the ability of preschool children to identify joy, anger, and sadness. The study included 135 girls and 141 boys aged 36-72 months with a mean age of 52.4 months. The tests were conducted at nine daycare centers.

Children were shown photographs of 15 actors (5 men and 10 women) with and without surgical face masks. The total data set included 90 pictures illustrating joy, anger, and sadness. The children were shown the pictures at random, and they could either name the emotion, point to a card with emoticons showing the three emotions, or respond “I don’t know” or “quit the experiment.” Test sessions lasted approximately 7 minutes per child. Effect sizes were calculated using X² and Cramer V tests.

Overall, 68.8% of the children correctly identified the emotion portrayed; the correct response rate was 70.6% for faces without face masks and 66.9% for those with face masks. Correct recognition of joy was significantly higher for faces without masks than for those with masks (94.8% vs. 87.3), as was correct recognition of sadness (54.1% vs. 48.9%; P < .001 for both). Recognition of anger was not significantly different for unmasked and masked faces (62.2% vs. 64.6%, P = .10).

No significant differences in correct responses appeared between boys and girls and the rate of correct responses increased significantly with age. The rates of “I don’t know,” and “quit the experiment” responses were 3.1% and 2.2%, respectively. In an analysis of incorrect responses, approximately 25% of the children confused anger and sadness, and 21% misidentified joy for images of anger or sadness.

“Overall, participants in this study, who had been exposed to face masks for nearly a year, recognized emotions on pictures better than has been reported in previous research, even with face masks,” the researchers wrote.

The study findings were limited by several factors including the use of static pictures versus real individuals, which limits generalizability, and the lack of data on children with developmental issues, the researchers noted.

Despite relatively small differences and weak effect size (Cramer V scores of 0.2 or less for all), the results show a stronger recognition of emotion, compared with other studies, and highlight the importance of investigating the impact of face masks on other aspects of child development as the COVID-19 pandemic persists, the researchers concluded.

The study received no outside funding. The researchers had no relevant financial conflicts to disclose.

A majority of healthy preschoolers were able to recognize emotions shown in static pictures of adults with and without face masks, based on data from a cross-sectional study of 276 children.

Some are concerned about the effects of adults working in preschools wearing face masks on the ability of young children to learn to recognize emotions, study author Juliane Schneider, MD, of University Hospital Lausanne (Switzerland), and colleagues wrote. Previous studies using photographs of faces with digitally added masks have suggested that young children’s emotional recognition was worse with masked faces.

In the study published in JAMA Pediatrics, the researchers tested the impact of masks on the ability of preschool children to identify joy, anger, and sadness. The study included 135 girls and 141 boys aged 36-72 months with a mean age of 52.4 months. The tests were conducted at nine daycare centers.

Children were shown photographs of 15 actors (5 men and 10 women) with and without surgical face masks. The total data set included 90 pictures illustrating joy, anger, and sadness. The children were shown the pictures at random, and they could either name the emotion, point to a card with emoticons showing the three emotions, or respond “I don’t know” or “quit the experiment.” Test sessions lasted approximately 7 minutes per child. Effect sizes were calculated using X² and Cramer V tests.

Overall, 68.8% of the children correctly identified the emotion portrayed; the correct response rate was 70.6% for faces without face masks and 66.9% for those with face masks. Correct recognition of joy was significantly higher for faces without masks than for those with masks (94.8% vs. 87.3), as was correct recognition of sadness (54.1% vs. 48.9%; P < .001 for both). Recognition of anger was not significantly different for unmasked and masked faces (62.2% vs. 64.6%, P = .10).

No significant differences in correct responses appeared between boys and girls and the rate of correct responses increased significantly with age. The rates of “I don’t know,” and “quit the experiment” responses were 3.1% and 2.2%, respectively. In an analysis of incorrect responses, approximately 25% of the children confused anger and sadness, and 21% misidentified joy for images of anger or sadness.

“Overall, participants in this study, who had been exposed to face masks for nearly a year, recognized emotions on pictures better than has been reported in previous research, even with face masks,” the researchers wrote.

The study findings were limited by several factors including the use of static pictures versus real individuals, which limits generalizability, and the lack of data on children with developmental issues, the researchers noted.

Despite relatively small differences and weak effect size (Cramer V scores of 0.2 or less for all), the results show a stronger recognition of emotion, compared with other studies, and highlight the importance of investigating the impact of face masks on other aspects of child development as the COVID-19 pandemic persists, the researchers concluded.

The study received no outside funding. The researchers had no relevant financial conflicts to disclose.

On Nov. 12, president Joe Biden said he will nominate Robert Califf, MD, to be commissioner of the U.S. Food and Drug Administration, the top U.S. regulator of drugs and medical devices.

Dr. Califf, a cardiologist, served as FDA chief in the Obama administration, leading the agency from Feb. 2016 to Jan. 2017.

The coming nomination ends nearly 11 months of speculation over Mr. Biden’s pick to the lead the agency during the ongoing pandemic. Janet Woodcock, MD, an FDA veteran, has been serving as acting commissioner. The White House faced a Tuesday deadline to make a nomination or see Dr. Woodcock’s tenure as acting chief expire under federal law.

The initial reaction to the idea of Dr. Califf’s return to the FDA drew mixed reactions.

The nonprofit watchdog Public Citizen issued a statement about its opposition to the potential nomination of Dr. Califf. Michael Carome, MD, director of Public Citizen’s Health Research Group, said the United States “desperately needs an FDA leader who will reverse the decades-long trend in which the agency’s relationship with the pharmaceutical and medical-device industries has grown dangerously cozier – resulting in regulatory capture of the agency by industry.”

But the idea of Dr. Califf returning to the FDA pleased Harlan Krumholz, MD, a cardiologist who has been a leader in outcomes research.

Dr. Krumholz tweeted that the Biden administration likely was testing the reaction to a possible Dr. Califf nomination before making it official. “I realize that this is being floated and not officially announced ... but the nomination of [Califf] just makes so much sense,” Dr. Krumholz tweeted. Dr. Califf’s “expertise as a researcher, policymaker, clinician are unparalleled. In a time of partisanship, he should be a slam-dunk confirmation.”

Dr. Califf’s 2016 Senate confirmation process was marked by dissent from several Democrats who questioned his ties to industry. But the chamber voted 89-4 to confirm him.

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

On Nov. 12, president Joe Biden said he will nominate Robert Califf, MD, to be commissioner of the U.S. Food and Drug Administration, the top U.S. regulator of drugs and medical devices.

Dr. Califf, a cardiologist, served as FDA chief in the Obama administration, leading the agency from Feb. 2016 to Jan. 2017.

The coming nomination ends nearly 11 months of speculation over Mr. Biden’s pick to the lead the agency during the ongoing pandemic. Janet Woodcock, MD, an FDA veteran, has been serving as acting commissioner. The White House faced a Tuesday deadline to make a nomination or see Dr. Woodcock’s tenure as acting chief expire under federal law.

The initial reaction to the idea of Dr. Califf’s return to the FDA drew mixed reactions.

The nonprofit watchdog Public Citizen issued a statement about its opposition to the potential nomination of Dr. Califf. Michael Carome, MD, director of Public Citizen’s Health Research Group, said the United States “desperately needs an FDA leader who will reverse the decades-long trend in which the agency’s relationship with the pharmaceutical and medical-device industries has grown dangerously cozier – resulting in regulatory capture of the agency by industry.”

But the idea of Dr. Califf returning to the FDA pleased Harlan Krumholz, MD, a cardiologist who has been a leader in outcomes research.

Dr. Krumholz tweeted that the Biden administration likely was testing the reaction to a possible Dr. Califf nomination before making it official. “I realize that this is being floated and not officially announced ... but the nomination of [Califf] just makes so much sense,” Dr. Krumholz tweeted. Dr. Califf’s “expertise as a researcher, policymaker, clinician are unparalleled. In a time of partisanship, he should be a slam-dunk confirmation.”

Dr. Califf’s 2016 Senate confirmation process was marked by dissent from several Democrats who questioned his ties to industry. But the chamber voted 89-4 to confirm him.

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

On Nov. 12, president Joe Biden said he will nominate Robert Califf, MD, to be commissioner of the U.S. Food and Drug Administration, the top U.S. regulator of drugs and medical devices.

Dr. Califf, a cardiologist, served as FDA chief in the Obama administration, leading the agency from Feb. 2016 to Jan. 2017.

The coming nomination ends nearly 11 months of speculation over Mr. Biden’s pick to the lead the agency during the ongoing pandemic. Janet Woodcock, MD, an FDA veteran, has been serving as acting commissioner. The White House faced a Tuesday deadline to make a nomination or see Dr. Woodcock’s tenure as acting chief expire under federal law.

The initial reaction to the idea of Dr. Califf’s return to the FDA drew mixed reactions.

The nonprofit watchdog Public Citizen issued a statement about its opposition to the potential nomination of Dr. Califf. Michael Carome, MD, director of Public Citizen’s Health Research Group, said the United States “desperately needs an FDA leader who will reverse the decades-long trend in which the agency’s relationship with the pharmaceutical and medical-device industries has grown dangerously cozier – resulting in regulatory capture of the agency by industry.”

But the idea of Dr. Califf returning to the FDA pleased Harlan Krumholz, MD, a cardiologist who has been a leader in outcomes research.

Dr. Krumholz tweeted that the Biden administration likely was testing the reaction to a possible Dr. Califf nomination before making it official. “I realize that this is being floated and not officially announced ... but the nomination of [Califf] just makes so much sense,” Dr. Krumholz tweeted. Dr. Califf’s “expertise as a researcher, policymaker, clinician are unparalleled. In a time of partisanship, he should be a slam-dunk confirmation.”

Dr. Califf’s 2016 Senate confirmation process was marked by dissent from several Democrats who questioned his ties to industry. But the chamber voted 89-4 to confirm him.

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

Despite objections from the American Psychiatric Association and other national groups, federal regulators are sticking to the Nov. 15 deadline for the modified clozapine risk evaluation and mitigation strategy (REMS) program.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

The modifications will require all those who prescribe and dispense clozapine to be recertified. Prescribers and pharmacies who fail to be certified by this date will no longer be able to prescribe/dispense the drug. In addition, clinicians must re-enroll all patients who are currently taking the medication.

Clozapine is used to treat schizophrenia that is not well controlled with standard antipsychotics. It is also prescribed to patients with recurrent suicidal behavior associated with schizophrenia or schizoaffective disorder.

Although it is highly effective in some patients, it also carries serious risks. Specifically, it can decrease the neutrophil count, which can lead to severe neutropenia, serious infections, and death. As a result, those taking the drug must undergo regular absolute neutrophil count (ANC) monitoring. Clozapine REMS is intended to maximize the benefits of the drug and minimize risk.

The U.S. Food and Drug Administration first announced modifications to the program in July. Under the new rules, pharmacies will no longer be permitted to use telecommunication verification, also known as the switch system, to verify safe use conditions. Instead, the authorization to dispense will be obtained either through the contact center or online via the REMS website.

Furthermore, a new patient status form (PFS) will be used to document absolute ANC monitoring for all outpatients and the form must be submitted monthly.

In addition to the APA, opponents of the new recertification rules include the College of Psychiatric and Neurologic Pharmacists, the National Council for Mental Wellbeing, the National Association of State Mental Health Program Directors, the National Alliance on Mental Illness, the American Psychiatric Nurses Association, and the American Pharmacists Association.

No more access to patient data

Among other concerns, the coalition argues the new requirements will make it more difficult for clinicians to access data on patients’ previous clozapine history. Many clinicians depend on these data, which were maintained in the earlier REMS and in previous manufacturer-maintained clozapine monitoring systems.

The FDA told this news organization in a statement that the Clozapine Products Manufacturers’ Group “was not able to incorporate this data into the modified REMS database because of technical reasons. The new REMS contact center will have access to the historical data should a health care provider need the information,” the FDA said.

The FDA could not immediately provide this news organization with more detail on the nature of the “technical reasons” cited as a cause for the new hurdle that prevents clinicians from accessing these previously available data.

In a September letter to the FDA, the coalition pushed back, writing that it is “unreasonable to deny prescribers of this data that they entered. Furthermore, the lack of historical data could result in harm to patients in some circumstances.”

The coalition asked the FDA to intervene and ask the drug’s manufacturers to reinstate prescriber access to the information.

In a response to questions on this issue from this news organization, the FDA said in a written response the historical data had not been lost, but would be maintained “for record-keeping purposes.”

The FDA also said agency officials met on Oct. 10 with members of the professional organizations who authored the letter to hear their concerns about the clozapine REMS program. The CPMG, which has the responsibility for implementing the REMS, was also represented at the meeting, the FDA said.

“Based on concerns raised by stakeholders, the CPMG has recently begun to address some of the concerns raised in the letter including updating the prescriber/prescriber designee relationship and enrollment process to allow for a designee to be affiliated with multiple prescribers,” the FDA told this news organization.

“The recent updates also enable prescriber designees to self-enroll/create credentials, send affiliation requests to prescribers, and attest/perform functions on behalf of prescribers. It is our understanding that the CPMG is disseminating this information to stakeholders,” the agency added.

Bigger burden, bad timing

In an interview, Robert Cotes, MD, who serves as a member of the clinical expert team for Serious Mental Illness Adviser, a joint initiative of the APA and the Substance Abuse and Mental Health Services Administration, said the changes to the clozapine REMS will likely increase the administrative burden on clinicians.

In the letter to the FDA, the APA and other groups in the coalition expressed concern about patient status forms, which are five pages long. The coalition has requested that the FDA develop a form where clinicians can submit monitoring results on multiple patients at one time, with PDF forms presented in a fillable format.

“The concern is that if the workflows become more laborious for people, it could result in treatment interruptions for individuals on clozapine or potentially it may steer prescribers away from using clozapine for people who may need it,” said Dr. Cotes.

Also commenting for this news organization, Raymond C. Love, PharmD, professor and vice chair at the University of Maryland School of Pharmacy, Baltimore, emphasized the poor timing of the switch to a new clozapine REMS.

“Pharmacies are overloaded right now due to COVID tests and influenza and COVID boosters and COVID vaccinations for kids,” making it a tough time to manage the demands of the clozapine REMS re-enrollment, he said.

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

Despite objections from the American Psychiatric Association and other national groups, federal regulators are sticking to the Nov. 15 deadline for the modified clozapine risk evaluation and mitigation strategy (REMS) program.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

The modifications will require all those who prescribe and dispense clozapine to be recertified. Prescribers and pharmacies who fail to be certified by this date will no longer be able to prescribe/dispense the drug. In addition, clinicians must re-enroll all patients who are currently taking the medication.

Clozapine is used to treat schizophrenia that is not well controlled with standard antipsychotics. It is also prescribed to patients with recurrent suicidal behavior associated with schizophrenia or schizoaffective disorder.

Although it is highly effective in some patients, it also carries serious risks. Specifically, it can decrease the neutrophil count, which can lead to severe neutropenia, serious infections, and death. As a result, those taking the drug must undergo regular absolute neutrophil count (ANC) monitoring. Clozapine REMS is intended to maximize the benefits of the drug and minimize risk.

The U.S. Food and Drug Administration first announced modifications to the program in July. Under the new rules, pharmacies will no longer be permitted to use telecommunication verification, also known as the switch system, to verify safe use conditions. Instead, the authorization to dispense will be obtained either through the contact center or online via the REMS website.

Furthermore, a new patient status form (PFS) will be used to document absolute ANC monitoring for all outpatients and the form must be submitted monthly.

In addition to the APA, opponents of the new recertification rules include the College of Psychiatric and Neurologic Pharmacists, the National Council for Mental Wellbeing, the National Association of State Mental Health Program Directors, the National Alliance on Mental Illness, the American Psychiatric Nurses Association, and the American Pharmacists Association.

No more access to patient data

Among other concerns, the coalition argues the new requirements will make it more difficult for clinicians to access data on patients’ previous clozapine history. Many clinicians depend on these data, which were maintained in the earlier REMS and in previous manufacturer-maintained clozapine monitoring systems.

The FDA told this news organization in a statement that the Clozapine Products Manufacturers’ Group “was not able to incorporate this data into the modified REMS database because of technical reasons. The new REMS contact center will have access to the historical data should a health care provider need the information,” the FDA said.

The FDA could not immediately provide this news organization with more detail on the nature of the “technical reasons” cited as a cause for the new hurdle that prevents clinicians from accessing these previously available data.

In a September letter to the FDA, the coalition pushed back, writing that it is “unreasonable to deny prescribers of this data that they entered. Furthermore, the lack of historical data could result in harm to patients in some circumstances.”

The coalition asked the FDA to intervene and ask the drug’s manufacturers to reinstate prescriber access to the information.

In a response to questions on this issue from this news organization, the FDA said in a written response the historical data had not been lost, but would be maintained “for record-keeping purposes.”

The FDA also said agency officials met on Oct. 10 with members of the professional organizations who authored the letter to hear their concerns about the clozapine REMS program. The CPMG, which has the responsibility for implementing the REMS, was also represented at the meeting, the FDA said.

“Based on concerns raised by stakeholders, the CPMG has recently begun to address some of the concerns raised in the letter including updating the prescriber/prescriber designee relationship and enrollment process to allow for a designee to be affiliated with multiple prescribers,” the FDA told this news organization.

“The recent updates also enable prescriber designees to self-enroll/create credentials, send affiliation requests to prescribers, and attest/perform functions on behalf of prescribers. It is our understanding that the CPMG is disseminating this information to stakeholders,” the agency added.

Bigger burden, bad timing

In an interview, Robert Cotes, MD, who serves as a member of the clinical expert team for Serious Mental Illness Adviser, a joint initiative of the APA and the Substance Abuse and Mental Health Services Administration, said the changes to the clozapine REMS will likely increase the administrative burden on clinicians.

In the letter to the FDA, the APA and other groups in the coalition expressed concern about patient status forms, which are five pages long. The coalition has requested that the FDA develop a form where clinicians can submit monitoring results on multiple patients at one time, with PDF forms presented in a fillable format.

“The concern is that if the workflows become more laborious for people, it could result in treatment interruptions for individuals on clozapine or potentially it may steer prescribers away from using clozapine for people who may need it,” said Dr. Cotes.

Also commenting for this news organization, Raymond C. Love, PharmD, professor and vice chair at the University of Maryland School of Pharmacy, Baltimore, emphasized the poor timing of the switch to a new clozapine REMS.

“Pharmacies are overloaded right now due to COVID tests and influenza and COVID boosters and COVID vaccinations for kids,” making it a tough time to manage the demands of the clozapine REMS re-enrollment, he said.

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

Despite objections from the American Psychiatric Association and other national groups, federal regulators are sticking to the Nov. 15 deadline for the modified clozapine risk evaluation and mitigation strategy (REMS) program.

Wikimedia Commons/FitzColinGerald/ Creative Commons License

The modifications will require all those who prescribe and dispense clozapine to be recertified. Prescribers and pharmacies who fail to be certified by this date will no longer be able to prescribe/dispense the drug. In addition, clinicians must re-enroll all patients who are currently taking the medication.

Clozapine is used to treat schizophrenia that is not well controlled with standard antipsychotics. It is also prescribed to patients with recurrent suicidal behavior associated with schizophrenia or schizoaffective disorder.

Although it is highly effective in some patients, it also carries serious risks. Specifically, it can decrease the neutrophil count, which can lead to severe neutropenia, serious infections, and death. As a result, those taking the drug must undergo regular absolute neutrophil count (ANC) monitoring. Clozapine REMS is intended to maximize the benefits of the drug and minimize risk.

The U.S. Food and Drug Administration first announced modifications to the program in July. Under the new rules, pharmacies will no longer be permitted to use telecommunication verification, also known as the switch system, to verify safe use conditions. Instead, the authorization to dispense will be obtained either through the contact center or online via the REMS website.

Furthermore, a new patient status form (PFS) will be used to document absolute ANC monitoring for all outpatients and the form must be submitted monthly.

In addition to the APA, opponents of the new recertification rules include the College of Psychiatric and Neurologic Pharmacists, the National Council for Mental Wellbeing, the National Association of State Mental Health Program Directors, the National Alliance on Mental Illness, the American Psychiatric Nurses Association, and the American Pharmacists Association.

No more access to patient data

Among other concerns, the coalition argues the new requirements will make it more difficult for clinicians to access data on patients’ previous clozapine history. Many clinicians depend on these data, which were maintained in the earlier REMS and in previous manufacturer-maintained clozapine monitoring systems.

The FDA told this news organization in a statement that the Clozapine Products Manufacturers’ Group “was not able to incorporate this data into the modified REMS database because of technical reasons. The new REMS contact center will have access to the historical data should a health care provider need the information,” the FDA said.

The FDA could not immediately provide this news organization with more detail on the nature of the “technical reasons” cited as a cause for the new hurdle that prevents clinicians from accessing these previously available data.

In a September letter to the FDA, the coalition pushed back, writing that it is “unreasonable to deny prescribers of this data that they entered. Furthermore, the lack of historical data could result in harm to patients in some circumstances.”

The coalition asked the FDA to intervene and ask the drug’s manufacturers to reinstate prescriber access to the information.

In a response to questions on this issue from this news organization, the FDA said in a written response the historical data had not been lost, but would be maintained “for record-keeping purposes.”

The FDA also said agency officials met on Oct. 10 with members of the professional organizations who authored the letter to hear their concerns about the clozapine REMS program. The CPMG, which has the responsibility for implementing the REMS, was also represented at the meeting, the FDA said.

“Based on concerns raised by stakeholders, the CPMG has recently begun to address some of the concerns raised in the letter including updating the prescriber/prescriber designee relationship and enrollment process to allow for a designee to be affiliated with multiple prescribers,” the FDA told this news organization.

“The recent updates also enable prescriber designees to self-enroll/create credentials, send affiliation requests to prescribers, and attest/perform functions on behalf of prescribers. It is our understanding that the CPMG is disseminating this information to stakeholders,” the agency added.

Bigger burden, bad timing

In an interview, Robert Cotes, MD, who serves as a member of the clinical expert team for Serious Mental Illness Adviser, a joint initiative of the APA and the Substance Abuse and Mental Health Services Administration, said the changes to the clozapine REMS will likely increase the administrative burden on clinicians.

In the letter to the FDA, the APA and other groups in the coalition expressed concern about patient status forms, which are five pages long. The coalition has requested that the FDA develop a form where clinicians can submit monitoring results on multiple patients at one time, with PDF forms presented in a fillable format.

“The concern is that if the workflows become more laborious for people, it could result in treatment interruptions for individuals on clozapine or potentially it may steer prescribers away from using clozapine for people who may need it,” said Dr. Cotes.

Also commenting for this news organization, Raymond C. Love, PharmD, professor and vice chair at the University of Maryland School of Pharmacy, Baltimore, emphasized the poor timing of the switch to a new clozapine REMS.

“Pharmacies are overloaded right now due to COVID tests and influenza and COVID boosters and COVID vaccinations for kids,” making it a tough time to manage the demands of the clozapine REMS re-enrollment, he said.

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

COVID-19 has been difficult for parents trying to balance careers, home life, and keeping their loved ones safe. A new study indicates that, not only are physicians not immune to these stressors, but the long-term effects could be devastating for health care overall.

Juanmonino/Getty Images

In a study published Nov. 11, 2021, in JAMA Network Open , researchers found that stresses to work/life balance and family life caused by the pandemic have differed among men and women physicians. Women physicians have borne more of the burden, and the consequences could reach far beyond home.

Physicians and other health care workers have been at the front lines of the COVID-19 pandemic, and their work lives have been the focus of a lot of attention in the media and by researchers. Their family lives, not so much. But physicians have families, and the pandemic has upended almost everything about their lives, particularly where work life and home life intersect. School and day care closures, working from home, working extra hours, or working less – all of these changes have consequences on family life and the mental health of parents who are also physicians.

Findings from a Medscape survey published in early 2021 indicate that more female physicians than male physicians were either “conflicted” or “very conflicted” as parents because of work demands (42% vs. 23%) nearly 6 months into the pandemic.

In the current study, researchers from the University of Michigan, Harvard University, and the Medical University of South Carolina teamed up to investigate gender differences in how work/family factors affected the mental health of early-career physician parents in the United States during the first year of the COVID-19 pandemic. The results suggest that the pandemic has increased gender disparity and added disproportionately to the burden of female physicians.
 

Managing the household falls mostly on moms

Participants were physicians enrolled in the Intern Health Study, a longitudinal study that regularly surveys medical interns in the United States to assess stress and mood. When researchers compared survey results from before the onset of the pandemic (2018) with later results (2020), they found a striking gender difference in how the pandemic has changed family and work duties for physicians.

The authors of the study pointed out that previous research had found that female physicians take on a greater share of household and childcare duties than male physicians. The current study found that their share had increased with the pandemic. Physician moms are now 30 times more likely to be in charge of these tasks than physician dads.

In families in which both parents were physicians, none of the men said they took the primary role in managing the extra demands caused by the pandemic. In addition, women were twice as likely as men to work primarily from home and to work reduced hours.

The extra stress seems to be taking a toll on women physicians. In the 2020 survey, physician mothers had higher scores for anxiety and depression symptoms, compared with men. Notably, the 2018 survey did not show a significant difference in depression scores between men and women. Nor were there significant differences in depression and anxiety scores between women and men who were not parents or in reports of work/family conflict before and after the pandemic.

In general, the results indicate that the pandemic has only widened the gender gap between women and men physicians when it comes to managing family life and dealing with the stresses of maintaining a suitable work-life balance.
 

‘Long-term repercussions’ for gender equity in medicine

Although these are serious problems for women physicians and their families, the effects go beyond the home and beyond individuals. Even before the pandemic, women in medicine struggled for parity in career advancement and opportunities as well as in pay, and this new setback could make those challenges even greater.

“Even short-term adjustments can have serious long-term repercussions as they may lead to lower earnings and negatively impact opportunities for promotion, further exacerbating gender inequalities in compensation and advancement,” the study’s authors wrote.

The potential damage extends to the entire profession and the health care system itself. The profession is already struggling to retain young female physicians, and this situation is likely to make that problem worse and have long-term consequences. Citing data showing that female physicians spend more time with patients and that their patients may have better outcomes, the authors wrote that the consequences of losing more early-career female physicians “could be devastating to the U.S. health care system, particularly in the context of a global pandemic and an impending physician shortage.”

The sample size was small (276 U.S. physicians), and the study relied on self-reported data. The findings suggest that more research on this topic is needed, especially research that includes other demographic factors, such as sexual orientation and ethnicity. The authors recommend that institutional and public policymakers take into account the effects of the pandemic on physician mothers to ensure that recent gains in gender equity for women physicians do not fall victim to COVID-19.

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

COVID-19 has been difficult for parents trying to balance careers, home life, and keeping their loved ones safe. A new study indicates that, not only are physicians not immune to these stressors, but the long-term effects could be devastating for health care overall.

Juanmonino/Getty Images

In a study published Nov. 11, 2021, in JAMA Network Open , researchers found that stresses to work/life balance and family life caused by the pandemic have differed among men and women physicians. Women physicians have borne more of the burden, and the consequences could reach far beyond home.

Physicians and other health care workers have been at the front lines of the COVID-19 pandemic, and their work lives have been the focus of a lot of attention in the media and by researchers. Their family lives, not so much. But physicians have families, and the pandemic has upended almost everything about their lives, particularly where work life and home life intersect. School and day care closures, working from home, working extra hours, or working less – all of these changes have consequences on family life and the mental health of parents who are also physicians.

Findings from a Medscape survey published in early 2021 indicate that more female physicians than male physicians were either “conflicted” or “very conflicted” as parents because of work demands (42% vs. 23%) nearly 6 months into the pandemic.

In the current study, researchers from the University of Michigan, Harvard University, and the Medical University of South Carolina teamed up to investigate gender differences in how work/family factors affected the mental health of early-career physician parents in the United States during the first year of the COVID-19 pandemic. The results suggest that the pandemic has increased gender disparity and added disproportionately to the burden of female physicians.
 

Managing the household falls mostly on moms

Participants were physicians enrolled in the Intern Health Study, a longitudinal study that regularly surveys medical interns in the United States to assess stress and mood. When researchers compared survey results from before the onset of the pandemic (2018) with later results (2020), they found a striking gender difference in how the pandemic has changed family and work duties for physicians.

The authors of the study pointed out that previous research had found that female physicians take on a greater share of household and childcare duties than male physicians. The current study found that their share had increased with the pandemic. Physician moms are now 30 times more likely to be in charge of these tasks than physician dads.

In families in which both parents were physicians, none of the men said they took the primary role in managing the extra demands caused by the pandemic. In addition, women were twice as likely as men to work primarily from home and to work reduced hours.

The extra stress seems to be taking a toll on women physicians. In the 2020 survey, physician mothers had higher scores for anxiety and depression symptoms, compared with men. Notably, the 2018 survey did not show a significant difference in depression scores between men and women. Nor were there significant differences in depression and anxiety scores between women and men who were not parents or in reports of work/family conflict before and after the pandemic.

In general, the results indicate that the pandemic has only widened the gender gap between women and men physicians when it comes to managing family life and dealing with the stresses of maintaining a suitable work-life balance.
 

‘Long-term repercussions’ for gender equity in medicine

Although these are serious problems for women physicians and their families, the effects go beyond the home and beyond individuals. Even before the pandemic, women in medicine struggled for parity in career advancement and opportunities as well as in pay, and this new setback could make those challenges even greater.

“Even short-term adjustments can have serious long-term repercussions as they may lead to lower earnings and negatively impact opportunities for promotion, further exacerbating gender inequalities in compensation and advancement,” the study’s authors wrote.

The potential damage extends to the entire profession and the health care system itself. The profession is already struggling to retain young female physicians, and this situation is likely to make that problem worse and have long-term consequences. Citing data showing that female physicians spend more time with patients and that their patients may have better outcomes, the authors wrote that the consequences of losing more early-career female physicians “could be devastating to the U.S. health care system, particularly in the context of a global pandemic and an impending physician shortage.”

The sample size was small (276 U.S. physicians), and the study relied on self-reported data. The findings suggest that more research on this topic is needed, especially research that includes other demographic factors, such as sexual orientation and ethnicity. The authors recommend that institutional and public policymakers take into account the effects of the pandemic on physician mothers to ensure that recent gains in gender equity for women physicians do not fall victim to COVID-19.

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

COVID-19 has been difficult for parents trying to balance careers, home life, and keeping their loved ones safe. A new study indicates that, not only are physicians not immune to these stressors, but the long-term effects could be devastating for health care overall.

Juanmonino/Getty Images

In a study published Nov. 11, 2021, in JAMA Network Open , researchers found that stresses to work/life balance and family life caused by the pandemic have differed among men and women physicians. Women physicians have borne more of the burden, and the consequences could reach far beyond home.

Physicians and other health care workers have been at the front lines of the COVID-19 pandemic, and their work lives have been the focus of a lot of attention in the media and by researchers. Their family lives, not so much. But physicians have families, and the pandemic has upended almost everything about their lives, particularly where work life and home life intersect. School and day care closures, working from home, working extra hours, or working less – all of these changes have consequences on family life and the mental health of parents who are also physicians.

Findings from a Medscape survey published in early 2021 indicate that more female physicians than male physicians were either “conflicted” or “very conflicted” as parents because of work demands (42% vs. 23%) nearly 6 months into the pandemic.

In the current study, researchers from the University of Michigan, Harvard University, and the Medical University of South Carolina teamed up to investigate gender differences in how work/family factors affected the mental health of early-career physician parents in the United States during the first year of the COVID-19 pandemic. The results suggest that the pandemic has increased gender disparity and added disproportionately to the burden of female physicians.
 

Managing the household falls mostly on moms

Participants were physicians enrolled in the Intern Health Study, a longitudinal study that regularly surveys medical interns in the United States to assess stress and mood. When researchers compared survey results from before the onset of the pandemic (2018) with later results (2020), they found a striking gender difference in how the pandemic has changed family and work duties for physicians.

The authors of the study pointed out that previous research had found that female physicians take on a greater share of household and childcare duties than male physicians. The current study found that their share had increased with the pandemic. Physician moms are now 30 times more likely to be in charge of these tasks than physician dads.

In families in which both parents were physicians, none of the men said they took the primary role in managing the extra demands caused by the pandemic. In addition, women were twice as likely as men to work primarily from home and to work reduced hours.

The extra stress seems to be taking a toll on women physicians. In the 2020 survey, physician mothers had higher scores for anxiety and depression symptoms, compared with men. Notably, the 2018 survey did not show a significant difference in depression scores between men and women. Nor were there significant differences in depression and anxiety scores between women and men who were not parents or in reports of work/family conflict before and after the pandemic.

In general, the results indicate that the pandemic has only widened the gender gap between women and men physicians when it comes to managing family life and dealing with the stresses of maintaining a suitable work-life balance.
 

‘Long-term repercussions’ for gender equity in medicine

Although these are serious problems for women physicians and their families, the effects go beyond the home and beyond individuals. Even before the pandemic, women in medicine struggled for parity in career advancement and opportunities as well as in pay, and this new setback could make those challenges even greater.

“Even short-term adjustments can have serious long-term repercussions as they may lead to lower earnings and negatively impact opportunities for promotion, further exacerbating gender inequalities in compensation and advancement,” the study’s authors wrote.

The potential damage extends to the entire profession and the health care system itself. The profession is already struggling to retain young female physicians, and this situation is likely to make that problem worse and have long-term consequences. Citing data showing that female physicians spend more time with patients and that their patients may have better outcomes, the authors wrote that the consequences of losing more early-career female physicians “could be devastating to the U.S. health care system, particularly in the context of a global pandemic and an impending physician shortage.”

The sample size was small (276 U.S. physicians), and the study relied on self-reported data. The findings suggest that more research on this topic is needed, especially research that includes other demographic factors, such as sexual orientation and ethnicity. The authors recommend that institutional and public policymakers take into account the effects of the pandemic on physician mothers to ensure that recent gains in gender equity for women physicians do not fall victim to COVID-19.

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