Neurology Reviews

Some 30% of health care personnel who worked at the thousands of hospitals in the United States were still not fully vaccinated against COVID-19 as of mid-September, according to a new survey by the Centers for Disease Control and Prevention.

The snapshot in time – Jan. 20, 2021 to Sept. 15, 2021 – is based on voluntary weekly reports from hospitals. Only about 48% of the 5,085 hospitals in the U.S. Health and Human Services department’s Unified Hospital Data Surveillance System reported data on vaccination coverage during the period, and, after validation checks, the study included reports from 2,086 facilities, or just 41% of all hospitals, covering 3.35 million workers.

Overall, the number who were fully vaccinated rose from 36.1% in Jan. 2021 to 60.2% in April 2021, and then crept slowly up to 70% by Sept. 15, the CDC researchers reported in the American Journal of Infection Control.

The slowdown among hospital workers seems to mirror the same decline as in the general population.  

Arjun Srinivasan, MD, associate director for health care–associated infection prevention programs at the CDC, said the decline in part may be the result of misinformation.

Health care personnel “are not fully immune from vaccine misinformation,” he said, adding that such misinformation “is contributing to decreased vaccine uptake among non–health care personnel.”

“The take-home message is that there is a lot of work to do in health care settings in order to get all of our health care personnel vaccinated,” Dr. Srinivasan told this news organization. “We need them to be vaccinated to protect themselves. It is also really important that we as health care personnel get vaccinated to protect our patients.”
 

Vaccine mandates

The analysis shows that workers were more likely to be vaccinated if they worked at a children’s hospital (77%), lived in metropolitan counties (71%), or worked in a hospital with lower cumulative admissions of COVID-19 patients, or lower cumulative COVID-19 cases.

The odds of being fully vaccinated were lower if the surrounding community had lower vaccination coverage. Workers in non-metropolitan counties (63.3%) and in rural counties (65.1%) were also less likely to be fully vaccinated, as well as those who were in critical access hospitals (64%) or long-term acute care hospitals (68.8%).

Surveys have shown that health care personnel who are vaccine-hesitant cited concerns they had about vaccine efficacy, adverse effects, the speed of vaccine development, and lack of full Food and Drug Administration approval, the study authors noted. In addition, many reported low trust in the government.

A Medscape survey this past April found that 25% of health care workers said they did not plan to be fully vaccinated. Some 40% of the 9,349 workers who responded said that employers should never require a COVID-19 vaccine for clinicians.

But the Centers for Medicare & Medicaid Services is attempting to require all health care facilities that receive Medicare or Medicaid payment to vaccinate workers. All eligible staff must receive the first dose of a two-dose COVID-19 vaccine or a one-dose vaccine by Dec. 6, and a second dose by Jan. 4, 2022. The policy allows exemptions based on recognized medical conditions or religious beliefs.

Some hospitals and health systems and various states and cities have already begun implementing vaccine mandates. Northwell Health in New York, for instance, lost 1,400 workers (evenly split between clinical and nonclinical staff), or 2% of its 77,000 employees, as a result of the state’s mandate.

Northwell’s workforce is now considered 100% vaccinated, a hospital spokesman said in an interview. In addition, “we have allowed for team members who changed their minds and presented proof of vaccination to return,” said the spokesman, adding that “a couple of hundred employees have done just that.”

Ten states sued the Biden administration recently, aiming to stop the health care worker vaccine mandate. Other challenges to vaccine mandates have generally been unsuccessful. The U.S. Supreme Court, for example, in October declined to hear a challenge to Maine’s mandate for health care workers, even though it did not allow religious exemptions, according to the Washington Post.

“The courts seem to agree that health care personnel are different, and could be subject to these mandates,” said Dr. Srinivasan.

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

Some 30% of health care personnel who worked at the thousands of hospitals in the United States were still not fully vaccinated against COVID-19 as of mid-September, according to a new survey by the Centers for Disease Control and Prevention.

The snapshot in time – Jan. 20, 2021 to Sept. 15, 2021 – is based on voluntary weekly reports from hospitals. Only about 48% of the 5,085 hospitals in the U.S. Health and Human Services department’s Unified Hospital Data Surveillance System reported data on vaccination coverage during the period, and, after validation checks, the study included reports from 2,086 facilities, or just 41% of all hospitals, covering 3.35 million workers.

Overall, the number who were fully vaccinated rose from 36.1% in Jan. 2021 to 60.2% in April 2021, and then crept slowly up to 70% by Sept. 15, the CDC researchers reported in the American Journal of Infection Control.

The slowdown among hospital workers seems to mirror the same decline as in the general population.  

Arjun Srinivasan, MD, associate director for health care–associated infection prevention programs at the CDC, said the decline in part may be the result of misinformation.

Health care personnel “are not fully immune from vaccine misinformation,” he said, adding that such misinformation “is contributing to decreased vaccine uptake among non–health care personnel.”

“The take-home message is that there is a lot of work to do in health care settings in order to get all of our health care personnel vaccinated,” Dr. Srinivasan told this news organization. “We need them to be vaccinated to protect themselves. It is also really important that we as health care personnel get vaccinated to protect our patients.”
 

Vaccine mandates

The analysis shows that workers were more likely to be vaccinated if they worked at a children’s hospital (77%), lived in metropolitan counties (71%), or worked in a hospital with lower cumulative admissions of COVID-19 patients, or lower cumulative COVID-19 cases.

The odds of being fully vaccinated were lower if the surrounding community had lower vaccination coverage. Workers in non-metropolitan counties (63.3%) and in rural counties (65.1%) were also less likely to be fully vaccinated, as well as those who were in critical access hospitals (64%) or long-term acute care hospitals (68.8%).

Surveys have shown that health care personnel who are vaccine-hesitant cited concerns they had about vaccine efficacy, adverse effects, the speed of vaccine development, and lack of full Food and Drug Administration approval, the study authors noted. In addition, many reported low trust in the government.

A Medscape survey this past April found that 25% of health care workers said they did not plan to be fully vaccinated. Some 40% of the 9,349 workers who responded said that employers should never require a COVID-19 vaccine for clinicians.

But the Centers for Medicare & Medicaid Services is attempting to require all health care facilities that receive Medicare or Medicaid payment to vaccinate workers. All eligible staff must receive the first dose of a two-dose COVID-19 vaccine or a one-dose vaccine by Dec. 6, and a second dose by Jan. 4, 2022. The policy allows exemptions based on recognized medical conditions or religious beliefs.

Some hospitals and health systems and various states and cities have already begun implementing vaccine mandates. Northwell Health in New York, for instance, lost 1,400 workers (evenly split between clinical and nonclinical staff), or 2% of its 77,000 employees, as a result of the state’s mandate.

Northwell’s workforce is now considered 100% vaccinated, a hospital spokesman said in an interview. In addition, “we have allowed for team members who changed their minds and presented proof of vaccination to return,” said the spokesman, adding that “a couple of hundred employees have done just that.”

Ten states sued the Biden administration recently, aiming to stop the health care worker vaccine mandate. Other challenges to vaccine mandates have generally been unsuccessful. The U.S. Supreme Court, for example, in October declined to hear a challenge to Maine’s mandate for health care workers, even though it did not allow religious exemptions, according to the Washington Post.

“The courts seem to agree that health care personnel are different, and could be subject to these mandates,” said Dr. Srinivasan.

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

Some 30% of health care personnel who worked at the thousands of hospitals in the United States were still not fully vaccinated against COVID-19 as of mid-September, according to a new survey by the Centers for Disease Control and Prevention.

The snapshot in time – Jan. 20, 2021 to Sept. 15, 2021 – is based on voluntary weekly reports from hospitals. Only about 48% of the 5,085 hospitals in the U.S. Health and Human Services department’s Unified Hospital Data Surveillance System reported data on vaccination coverage during the period, and, after validation checks, the study included reports from 2,086 facilities, or just 41% of all hospitals, covering 3.35 million workers.

Overall, the number who were fully vaccinated rose from 36.1% in Jan. 2021 to 60.2% in April 2021, and then crept slowly up to 70% by Sept. 15, the CDC researchers reported in the American Journal of Infection Control.

The slowdown among hospital workers seems to mirror the same decline as in the general population.  

Arjun Srinivasan, MD, associate director for health care–associated infection prevention programs at the CDC, said the decline in part may be the result of misinformation.

Health care personnel “are not fully immune from vaccine misinformation,” he said, adding that such misinformation “is contributing to decreased vaccine uptake among non–health care personnel.”

“The take-home message is that there is a lot of work to do in health care settings in order to get all of our health care personnel vaccinated,” Dr. Srinivasan told this news organization. “We need them to be vaccinated to protect themselves. It is also really important that we as health care personnel get vaccinated to protect our patients.”
 

Vaccine mandates

The analysis shows that workers were more likely to be vaccinated if they worked at a children’s hospital (77%), lived in metropolitan counties (71%), or worked in a hospital with lower cumulative admissions of COVID-19 patients, or lower cumulative COVID-19 cases.

The odds of being fully vaccinated were lower if the surrounding community had lower vaccination coverage. Workers in non-metropolitan counties (63.3%) and in rural counties (65.1%) were also less likely to be fully vaccinated, as well as those who were in critical access hospitals (64%) or long-term acute care hospitals (68.8%).

Surveys have shown that health care personnel who are vaccine-hesitant cited concerns they had about vaccine efficacy, adverse effects, the speed of vaccine development, and lack of full Food and Drug Administration approval, the study authors noted. In addition, many reported low trust in the government.

A Medscape survey this past April found that 25% of health care workers said they did not plan to be fully vaccinated. Some 40% of the 9,349 workers who responded said that employers should never require a COVID-19 vaccine for clinicians.

But the Centers for Medicare & Medicaid Services is attempting to require all health care facilities that receive Medicare or Medicaid payment to vaccinate workers. All eligible staff must receive the first dose of a two-dose COVID-19 vaccine or a one-dose vaccine by Dec. 6, and a second dose by Jan. 4, 2022. The policy allows exemptions based on recognized medical conditions or religious beliefs.

Some hospitals and health systems and various states and cities have already begun implementing vaccine mandates. Northwell Health in New York, for instance, lost 1,400 workers (evenly split between clinical and nonclinical staff), or 2% of its 77,000 employees, as a result of the state’s mandate.

Northwell’s workforce is now considered 100% vaccinated, a hospital spokesman said in an interview. In addition, “we have allowed for team members who changed their minds and presented proof of vaccination to return,” said the spokesman, adding that “a couple of hundred employees have done just that.”

Ten states sued the Biden administration recently, aiming to stop the health care worker vaccine mandate. Other challenges to vaccine mandates have generally been unsuccessful. The U.S. Supreme Court, for example, in October declined to hear a challenge to Maine’s mandate for health care workers, even though it did not allow religious exemptions, according to the Washington Post.

“The courts seem to agree that health care personnel are different, and could be subject to these mandates,” said Dr. Srinivasan.

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

Medical practices will likely have to confront a doctor at some point who treats staff badly or is too impaired to practice safely. Knowing what to say and do can lead to a positive outcome for the physician involved and the organization.

Misbehaving and impaired physicians put their organizations at risk, which can lead to malpractice/patient injury lawsuits, labor law and harassment claims, and a damaged reputation through negative social media reviews, said Debra Phairas, MBA, president of Practice and Liability Consultants LLC, at the annual meeting of the Medical Group Management Association (MGMA) .

“Verbal harassment or bullying claims can result in large dollar awards against the organizations that knew about the behavior and did nothing to stop it. Organizations can be sued for that,” says Ms. Phairas.

She recalls a doctor who called a female doctor “an entitled bitch” and the administrator “incompetent” in front of other staff. “He would pick on one department manager at every meeting and humiliate them in front of the others,” says Ms. Phairas.

After working with a human resources (HR) attorney and conducting independent reviews, they used a strategy Ms. Phairas calls her “3 C’s” for dealing with disruptive doctors.
 

Confront, correct, and/or counsel

The three C’s can work individually or together, depending on the doctor’s situation. Confronting a physician can start with an informal discussion; correcting can involve seeking a written apology that directly addresses the problem or sending a letter of admonition; and coaching or counseling can be offered. If the doctor resists those efforts, practice administrators can issue a final letter of warning and then suspend or terminate the physician, says Ms. Phairas.

Sometimes having a conversation with a disruptive doctor about the risks and consequences is enough to change the offending behavior, says Ms. Phairas.

She recalled being asked by a medical group to meet with a physician who she says was “snapping the bra straps of medical assistants in the hall — everyone there was horrified. I told him that’s not appropriate, that he was placing everyone at risk and they will terminate him if he didn’t stop. I asked for his commitment to stop, and he agreed,” says Ms. Phairas.

She also recommends implementing these strategies to prevent and deal with disruptive physicians:

• Implement a code of conduct and share it during interviews;
• Have zero tolerance policies and procedures for documenting behavior;
• Get advice from a good employment attorney;
• Implement written performance improvement plans;
• Provide resources to change the behavior;
• Follow through with suspension and termination; and
• Add to shareholder agreements a clause stating that partners/shareholders can gently ask or insist that the physician obtain counseling or help.

Getting impaired doctors help

Doctors can be impaired through substance abuse, a serious medical illness, mental illness, or age-related deterioration.

Life events such as divorce or the death of a spouse, child, or a physician partner can affect a doctor’s mental health. “In those cases, you need to have the courage to say you’re really depressed and we all agree you need to get help,” says Ms. Phairas.

She recalls one occasion in which a practice administration staff member could not locate a doctor whose patients were waiting to be seen. “He was so devastated from his divorce that he had crawled into a ball beneath his desk. She had to coax him out and tell him that they were worried about him and he needed to get help.”

Another reason doctors may not be performing well may be because of an undiagnosed medical illness. Doctors in an orthopedic group were mad at another partner who had slowed down and couldn’t help pay the expenses. “They were ready to terminate him when he went to the doctor and learned he had colon cancer,” says Ms. Phairas.

Ms. Phairas recommends that practices update their partner shareholder agreements regularly with the following:

• Include “fit for duty” examinations, especially after age 65.
• Insist that a physician be evaluated by a doctor outside the practice. The doctor may be one that they agree upon or one chosen by the local medical society president.
• Include in the agreement the clause, “Partners and employees will be subject to review for impairment due to matters including but not limited to age-related, physical, or mental conditions.”
• Establish a voting mechanism for terminating a physician.

Aging doctors who won’t retire

Some doctors have retired early because of COVID, whereas others are staying on because they are feeling financial pressures — they lost a lot of money last year and need to make up for it, says Ms. Phairas.

She warned that administrators have to be careful in dealing with older doctors because of age discrimination laws.

Doctors may not notice they are declining mentally until it becomes a problem. Ms. Phairas recalls an internist senior partner who started behaving erratically when he was 78 years old. “He wrote himself a $25,000 check from the organization’s funds without telling his partners, left a patient he should have been watching and she fell over and sued the practice, and the staff started noticing that he was forgetting or not doing things,” says Ms. Phairas.

She sought guidance from a good HR attorney and involved a malpractice attorney. She then met with the senior partner. “I reminded him of his Hippocratic Oath that he took when he became a doctor and told him that his actions were harming patients. I pleaded with him that it was time to retire. He didn’t.”

Because this physician wouldn’t retire, the practice referred to their updated shareholder agreement, which stated that they could insist that the physician undergo a neuropsychiatric assessment from a certified specialist. He didn’t pass the evaluation, which then provided evidence of his declining cognitive skills.

“All the doctors, myself, and the HR attorney talked to him about this and laid out all the facts. It was hard to say these things, but he listened and left. We went through the termination process to protect the practice and avoid litigation. The malpractice insurer also refused to renew his policy,” says Ms. Phairas.

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

Medical practices will likely have to confront a doctor at some point who treats staff badly or is too impaired to practice safely. Knowing what to say and do can lead to a positive outcome for the physician involved and the organization.

Misbehaving and impaired physicians put their organizations at risk, which can lead to malpractice/patient injury lawsuits, labor law and harassment claims, and a damaged reputation through negative social media reviews, said Debra Phairas, MBA, president of Practice and Liability Consultants LLC, at the annual meeting of the Medical Group Management Association (MGMA) .

“Verbal harassment or bullying claims can result in large dollar awards against the organizations that knew about the behavior and did nothing to stop it. Organizations can be sued for that,” says Ms. Phairas.

She recalls a doctor who called a female doctor “an entitled bitch” and the administrator “incompetent” in front of other staff. “He would pick on one department manager at every meeting and humiliate them in front of the others,” says Ms. Phairas.

After working with a human resources (HR) attorney and conducting independent reviews, they used a strategy Ms. Phairas calls her “3 C’s” for dealing with disruptive doctors.
 

Confront, correct, and/or counsel

The three C’s can work individually or together, depending on the doctor’s situation. Confronting a physician can start with an informal discussion; correcting can involve seeking a written apology that directly addresses the problem or sending a letter of admonition; and coaching or counseling can be offered. If the doctor resists those efforts, practice administrators can issue a final letter of warning and then suspend or terminate the physician, says Ms. Phairas.

Sometimes having a conversation with a disruptive doctor about the risks and consequences is enough to change the offending behavior, says Ms. Phairas.

She recalled being asked by a medical group to meet with a physician who she says was “snapping the bra straps of medical assistants in the hall — everyone there was horrified. I told him that’s not appropriate, that he was placing everyone at risk and they will terminate him if he didn’t stop. I asked for his commitment to stop, and he agreed,” says Ms. Phairas.

She also recommends implementing these strategies to prevent and deal with disruptive physicians:

• Implement a code of conduct and share it during interviews;
• Have zero tolerance policies and procedures for documenting behavior;
• Get advice from a good employment attorney;
• Implement written performance improvement plans;
• Provide resources to change the behavior;
• Follow through with suspension and termination; and
• Add to shareholder agreements a clause stating that partners/shareholders can gently ask or insist that the physician obtain counseling or help.

Getting impaired doctors help

Doctors can be impaired through substance abuse, a serious medical illness, mental illness, or age-related deterioration.

Life events such as divorce or the death of a spouse, child, or a physician partner can affect a doctor’s mental health. “In those cases, you need to have the courage to say you’re really depressed and we all agree you need to get help,” says Ms. Phairas.

She recalls one occasion in which a practice administration staff member could not locate a doctor whose patients were waiting to be seen. “He was so devastated from his divorce that he had crawled into a ball beneath his desk. She had to coax him out and tell him that they were worried about him and he needed to get help.”

Another reason doctors may not be performing well may be because of an undiagnosed medical illness. Doctors in an orthopedic group were mad at another partner who had slowed down and couldn’t help pay the expenses. “They were ready to terminate him when he went to the doctor and learned he had colon cancer,” says Ms. Phairas.

Ms. Phairas recommends that practices update their partner shareholder agreements regularly with the following:

• Include “fit for duty” examinations, especially after age 65.
• Insist that a physician be evaluated by a doctor outside the practice. The doctor may be one that they agree upon or one chosen by the local medical society president.
• Include in the agreement the clause, “Partners and employees will be subject to review for impairment due to matters including but not limited to age-related, physical, or mental conditions.”
• Establish a voting mechanism for terminating a physician.

Aging doctors who won’t retire

Some doctors have retired early because of COVID, whereas others are staying on because they are feeling financial pressures — they lost a lot of money last year and need to make up for it, says Ms. Phairas.

She warned that administrators have to be careful in dealing with older doctors because of age discrimination laws.

Doctors may not notice they are declining mentally until it becomes a problem. Ms. Phairas recalls an internist senior partner who started behaving erratically when he was 78 years old. “He wrote himself a $25,000 check from the organization’s funds without telling his partners, left a patient he should have been watching and she fell over and sued the practice, and the staff started noticing that he was forgetting or not doing things,” says Ms. Phairas.

She sought guidance from a good HR attorney and involved a malpractice attorney. She then met with the senior partner. “I reminded him of his Hippocratic Oath that he took when he became a doctor and told him that his actions were harming patients. I pleaded with him that it was time to retire. He didn’t.”

Because this physician wouldn’t retire, the practice referred to their updated shareholder agreement, which stated that they could insist that the physician undergo a neuropsychiatric assessment from a certified specialist. He didn’t pass the evaluation, which then provided evidence of his declining cognitive skills.

“All the doctors, myself, and the HR attorney talked to him about this and laid out all the facts. It was hard to say these things, but he listened and left. We went through the termination process to protect the practice and avoid litigation. The malpractice insurer also refused to renew his policy,” says Ms. Phairas.

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

Medical practices will likely have to confront a doctor at some point who treats staff badly or is too impaired to practice safely. Knowing what to say and do can lead to a positive outcome for the physician involved and the organization.

Misbehaving and impaired physicians put their organizations at risk, which can lead to malpractice/patient injury lawsuits, labor law and harassment claims, and a damaged reputation through negative social media reviews, said Debra Phairas, MBA, president of Practice and Liability Consultants LLC, at the annual meeting of the Medical Group Management Association (MGMA) .

“Verbal harassment or bullying claims can result in large dollar awards against the organizations that knew about the behavior and did nothing to stop it. Organizations can be sued for that,” says Ms. Phairas.

She recalls a doctor who called a female doctor “an entitled bitch” and the administrator “incompetent” in front of other staff. “He would pick on one department manager at every meeting and humiliate them in front of the others,” says Ms. Phairas.

After working with a human resources (HR) attorney and conducting independent reviews, they used a strategy Ms. Phairas calls her “3 C’s” for dealing with disruptive doctors.
 

Confront, correct, and/or counsel

The three C’s can work individually or together, depending on the doctor’s situation. Confronting a physician can start with an informal discussion; correcting can involve seeking a written apology that directly addresses the problem or sending a letter of admonition; and coaching or counseling can be offered. If the doctor resists those efforts, practice administrators can issue a final letter of warning and then suspend or terminate the physician, says Ms. Phairas.

Sometimes having a conversation with a disruptive doctor about the risks and consequences is enough to change the offending behavior, says Ms. Phairas.

She recalled being asked by a medical group to meet with a physician who she says was “snapping the bra straps of medical assistants in the hall — everyone there was horrified. I told him that’s not appropriate, that he was placing everyone at risk and they will terminate him if he didn’t stop. I asked for his commitment to stop, and he agreed,” says Ms. Phairas.

She also recommends implementing these strategies to prevent and deal with disruptive physicians:

• Implement a code of conduct and share it during interviews;
• Have zero tolerance policies and procedures for documenting behavior;
• Get advice from a good employment attorney;
• Implement written performance improvement plans;
• Provide resources to change the behavior;
• Follow through with suspension and termination; and
• Add to shareholder agreements a clause stating that partners/shareholders can gently ask or insist that the physician obtain counseling or help.

Getting impaired doctors help

Doctors can be impaired through substance abuse, a serious medical illness, mental illness, or age-related deterioration.

Life events such as divorce or the death of a spouse, child, or a physician partner can affect a doctor’s mental health. “In those cases, you need to have the courage to say you’re really depressed and we all agree you need to get help,” says Ms. Phairas.

She recalls one occasion in which a practice administration staff member could not locate a doctor whose patients were waiting to be seen. “He was so devastated from his divorce that he had crawled into a ball beneath his desk. She had to coax him out and tell him that they were worried about him and he needed to get help.”

Another reason doctors may not be performing well may be because of an undiagnosed medical illness. Doctors in an orthopedic group were mad at another partner who had slowed down and couldn’t help pay the expenses. “They were ready to terminate him when he went to the doctor and learned he had colon cancer,” says Ms. Phairas.

Ms. Phairas recommends that practices update their partner shareholder agreements regularly with the following:

• Include “fit for duty” examinations, especially after age 65.
• Insist that a physician be evaluated by a doctor outside the practice. The doctor may be one that they agree upon or one chosen by the local medical society president.
• Include in the agreement the clause, “Partners and employees will be subject to review for impairment due to matters including but not limited to age-related, physical, or mental conditions.”
• Establish a voting mechanism for terminating a physician.

Aging doctors who won’t retire

Some doctors have retired early because of COVID, whereas others are staying on because they are feeling financial pressures — they lost a lot of money last year and need to make up for it, says Ms. Phairas.

She warned that administrators have to be careful in dealing with older doctors because of age discrimination laws.

Doctors may not notice they are declining mentally until it becomes a problem. Ms. Phairas recalls an internist senior partner who started behaving erratically when he was 78 years old. “He wrote himself a $25,000 check from the organization’s funds without telling his partners, left a patient he should have been watching and she fell over and sued the practice, and the staff started noticing that he was forgetting or not doing things,” says Ms. Phairas.

She sought guidance from a good HR attorney and involved a malpractice attorney. She then met with the senior partner. “I reminded him of his Hippocratic Oath that he took when he became a doctor and told him that his actions were harming patients. I pleaded with him that it was time to retire. He didn’t.”

Because this physician wouldn’t retire, the practice referred to their updated shareholder agreement, which stated that they could insist that the physician undergo a neuropsychiatric assessment from a certified specialist. He didn’t pass the evaluation, which then provided evidence of his declining cognitive skills.

“All the doctors, myself, and the HR attorney talked to him about this and laid out all the facts. It was hard to say these things, but he listened and left. We went through the termination process to protect the practice and avoid litigation. The malpractice insurer also refused to renew his policy,” says Ms. Phairas.

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

The Food and Drug Administration has given the green light to third, or booster doses of the Pfizer and Moderna vaccines for everyone over the age of 18, ahead of the busy winter holiday season.

“Authorizing the use of a single booster dose of either the Moderna or Pfizer-BioNTech COVID-19 vaccine for individuals 18 years of age and older helps to provide continued protection against COVID-19, including the serious consequences that can occur, such as hospitalization and death,” said acting FDA Commissioner Janet Woodcock, MD, in an FDA press statement.

The Center for Disease Control and Prevention’s Advisory Committee on Immunization Practices will meet on Nov. 19 to review the science supporting a more widespread need for booster doses, and is expected to vote on official recommendations for their use in the United States. The CDC director must then sign off on the panel’s recommendations.

“As soon as the FDA reviews those data and provides an authorization, we at CDC will act swiftly,” Rochelle P. Walensky, MD, MPH, said at a recent White House briefing.

Several states – including Louisiana, Maine, and Colorado – have already authorized boosters for all adults as cases rise in Europe and across the Western and Northeastern regions of the United States.

FDA officials said they hoped that widening eligibility for boosters would cut down on confusion for people and hopefully speed uptake of the shots.

“Streamlining the eligibility criteria and making booster doses available to all individuals 18 years of age and older will also help to eliminate confusion about who may receive a booster dose and ensure booster doses are available to all who may need one,” said Peter Marks, MD, PhD, who heads the FDA’s Center for Biologics Evaluation and Research.

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

The Food and Drug Administration has given the green light to third, or booster doses of the Pfizer and Moderna vaccines for everyone over the age of 18, ahead of the busy winter holiday season.

“Authorizing the use of a single booster dose of either the Moderna or Pfizer-BioNTech COVID-19 vaccine for individuals 18 years of age and older helps to provide continued protection against COVID-19, including the serious consequences that can occur, such as hospitalization and death,” said acting FDA Commissioner Janet Woodcock, MD, in an FDA press statement.

The Center for Disease Control and Prevention’s Advisory Committee on Immunization Practices will meet on Nov. 19 to review the science supporting a more widespread need for booster doses, and is expected to vote on official recommendations for their use in the United States. The CDC director must then sign off on the panel’s recommendations.

“As soon as the FDA reviews those data and provides an authorization, we at CDC will act swiftly,” Rochelle P. Walensky, MD, MPH, said at a recent White House briefing.

Several states – including Louisiana, Maine, and Colorado – have already authorized boosters for all adults as cases rise in Europe and across the Western and Northeastern regions of the United States.

FDA officials said they hoped that widening eligibility for boosters would cut down on confusion for people and hopefully speed uptake of the shots.

“Streamlining the eligibility criteria and making booster doses available to all individuals 18 years of age and older will also help to eliminate confusion about who may receive a booster dose and ensure booster doses are available to all who may need one,” said Peter Marks, MD, PhD, who heads the FDA’s Center for Biologics Evaluation and Research.

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

The Food and Drug Administration has given the green light to third, or booster doses of the Pfizer and Moderna vaccines for everyone over the age of 18, ahead of the busy winter holiday season.

“Authorizing the use of a single booster dose of either the Moderna or Pfizer-BioNTech COVID-19 vaccine for individuals 18 years of age and older helps to provide continued protection against COVID-19, including the serious consequences that can occur, such as hospitalization and death,” said acting FDA Commissioner Janet Woodcock, MD, in an FDA press statement.

The Center for Disease Control and Prevention’s Advisory Committee on Immunization Practices will meet on Nov. 19 to review the science supporting a more widespread need for booster doses, and is expected to vote on official recommendations for their use in the United States. The CDC director must then sign off on the panel’s recommendations.

“As soon as the FDA reviews those data and provides an authorization, we at CDC will act swiftly,” Rochelle P. Walensky, MD, MPH, said at a recent White House briefing.

Several states – including Louisiana, Maine, and Colorado – have already authorized boosters for all adults as cases rise in Europe and across the Western and Northeastern regions of the United States.

FDA officials said they hoped that widening eligibility for boosters would cut down on confusion for people and hopefully speed uptake of the shots.

“Streamlining the eligibility criteria and making booster doses available to all individuals 18 years of age and older will also help to eliminate confusion about who may receive a booster dose and ensure booster doses are available to all who may need one,” said Peter Marks, MD, PhD, who heads the FDA’s Center for Biologics Evaluation and Research.

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

Erenumab, a calcitonin-gene related peptide receptor (CGRP) inhibitor, is more tolerable and effective than topiramate for treating patients with migraine, according to data from almost 800 patients in the first head-to-head trial of its kind.

The findings suggest that erenumab may help overcome longstanding issues with migraine medication adherence, and additional supportive data may alter treatment sequencing, reported lead author Uwe Reuter, MD, professor at Charité Universitätsmedizin Berlin, and colleagues.

“So far, no study has been done in order to compare the efficacy of a monoclonal antibody targeting the CGRP pathway to that of a standard of care oral preventive drug,” the investigators wrote in Cephalalgia.

The phase 4 HER-MES trial aimed to address this knowledge gap by enrolling 777 adult patients with a history of migraine. All patients reported migraine with or without aura for at least 1 year prior to screening. At baseline, most patients (65%) reported 8-14 migraine days per months, followed by 4-7 days (24.0%), and at least 15 days (11.0%). No patients had previously received topiramate or a CGRP-targeting agent.

“HER-MES includes a broad migraine population with two-thirds of the patients in the high-frequency migraine spectrum,” the investigators noted. “Despite a mean disease duration of about 20 years, almost 60% of the patients had not received previous prophylactic treatment, which underlines the long-standing problem of undertreatment in migraine.”

The trial had a double-dummy design; patients were randomized in a 1:1 ratio to receive either subcutaneous erenumab (70 or 140 mg/month) plus oral placebo, or oral topiramate (50-100 mg/day) plus subcutaneous placebo. The topiramate dose was uptitrated over the first 6 weeks. Treatments were given for a total of 24 weeks or until discontinuation due to adverse events, which was the primary endpoint. The secondary endpoint was efficacy over months 4-6, defined as at least 50% reduction in monthly migraine days, compared with baseline. Other patient-reported outcomes were also evaluated.

After 24 weeks, 95.1% of patients were still enrolled in the trial. Discontinuations due to adverse events were almost four times as common in the topiramate group than the erenumab group (38.9% vs. 10.6%; odds ratio [OR], 0.19; confidence interval, 0.13-0.27; P less than .001). Efficacy findings followed suit, with 55.4% of patients in the erenumab group reporting at least 50% reduction in monthly migraine days, compared with 31.2% of patients in the topiramate group (OR, 2.76; 95% CI, 2.06-3.71; P less than.001).

Erenumab significantly improved monthly migraine days, headache impact test (HIT-6) scores, and short form health survey version (SF-35v2) scores, including physical and mental components (P less than .001 for all).

Safety profiles aligned with previous findings.

“Compared to topiramate, treatment with erenumab has a superior tolerability profile and a significantly higher efficacy,” the investigators concluded. “HER-MES supports the potential of erenumab in overcoming issues of low adherence in clinical practice observed with topiramate, lessening migraine burden, and improving quality of life in a broad migraine population.”
 

Superior tolerability

Commenting on the study, Alan Rapoport, MD, clinical professor of neurology at the University of California, Los Angeles, and editor-in-chief of Neurology Reviews, said this is “a very important, very well conducted trial that documents what many of us already suspected; erenumab clearly has better tolerability than topiramate as well as better efficacy.”

Dr. Rapoport, a past president of the International Headache Society, said the study highlights an area of unmet need in neurology practice.

“Despite most patients in the trial having chronic headaches for 20 years, 60% of them had never received preventive treatment,” he said, noting that this reflects current practice in the United States.

Dr. Rapoport said primary care providers in the United States prescribe preventive migraine medications to 10%-15% of eligible patients. Prescribing rates for general neurologists are slightly higher, he said, ranging from 35% to 40%, while headache specialists prescribe 70%-90% of the time.

“How can we improve this situation?” Dr. Rapoport asked. “For years we have tried to improve it with education, but we need to do a better job. We need to educate our primary care physicians in more practical ways. We have to teach them how to make a diagnosis of high frequency migraine and chronic migraine and strongly suggest that those patients be put on appropriate preventive medications.”

Barriers to care may be systemic, according to Dr. Rapoport.

“One issue in the U.S. is that patients with commercial insurance are almost always required to fail two or three categories of older oral preventive migraine medications before they can get a monoclonal antibody or gepants for prevention,” he said. “It would be good if we could change that system so that patients that absolutely need the better tolerated, more effective preventive medications could get them sooner rather than later. This will help them feel and function better, with less pain, and eventually bring down the cost of migraine therapy.”

While Dr. Reuter and colleagues concluded that revised treatment sequencing may be warranted after more trials show similar results, Dr. Rapoport suggested that “this was such a large, well-performed, 6-month study with few dropouts, that further trials to confirm these findings are unnecessary, in my opinion.”

The HER-MES trial was funded by Novartis. Dr. Reuter and colleagues disclosed additional relationships with Eli Lilly, Teva Pharmaceutical, Allergan, and others. Dr. Rapoport was involved in early topiramate trials for prevention and migraine, and is a speaker for Amgen.

Erenumab, a calcitonin-gene related peptide receptor (CGRP) inhibitor, is more tolerable and effective than topiramate for treating patients with migraine, according to data from almost 800 patients in the first head-to-head trial of its kind.

The findings suggest that erenumab may help overcome longstanding issues with migraine medication adherence, and additional supportive data may alter treatment sequencing, reported lead author Uwe Reuter, MD, professor at Charité Universitätsmedizin Berlin, and colleagues.

“So far, no study has been done in order to compare the efficacy of a monoclonal antibody targeting the CGRP pathway to that of a standard of care oral preventive drug,” the investigators wrote in Cephalalgia.

The phase 4 HER-MES trial aimed to address this knowledge gap by enrolling 777 adult patients with a history of migraine. All patients reported migraine with or without aura for at least 1 year prior to screening. At baseline, most patients (65%) reported 8-14 migraine days per months, followed by 4-7 days (24.0%), and at least 15 days (11.0%). No patients had previously received topiramate or a CGRP-targeting agent.

“HER-MES includes a broad migraine population with two-thirds of the patients in the high-frequency migraine spectrum,” the investigators noted. “Despite a mean disease duration of about 20 years, almost 60% of the patients had not received previous prophylactic treatment, which underlines the long-standing problem of undertreatment in migraine.”

The trial had a double-dummy design; patients were randomized in a 1:1 ratio to receive either subcutaneous erenumab (70 or 140 mg/month) plus oral placebo, or oral topiramate (50-100 mg/day) plus subcutaneous placebo. The topiramate dose was uptitrated over the first 6 weeks. Treatments were given for a total of 24 weeks or until discontinuation due to adverse events, which was the primary endpoint. The secondary endpoint was efficacy over months 4-6, defined as at least 50% reduction in monthly migraine days, compared with baseline. Other patient-reported outcomes were also evaluated.

After 24 weeks, 95.1% of patients were still enrolled in the trial. Discontinuations due to adverse events were almost four times as common in the topiramate group than the erenumab group (38.9% vs. 10.6%; odds ratio [OR], 0.19; confidence interval, 0.13-0.27; P less than .001). Efficacy findings followed suit, with 55.4% of patients in the erenumab group reporting at least 50% reduction in monthly migraine days, compared with 31.2% of patients in the topiramate group (OR, 2.76; 95% CI, 2.06-3.71; P less than.001).

Erenumab significantly improved monthly migraine days, headache impact test (HIT-6) scores, and short form health survey version (SF-35v2) scores, including physical and mental components (P less than .001 for all).

Safety profiles aligned with previous findings.

“Compared to topiramate, treatment with erenumab has a superior tolerability profile and a significantly higher efficacy,” the investigators concluded. “HER-MES supports the potential of erenumab in overcoming issues of low adherence in clinical practice observed with topiramate, lessening migraine burden, and improving quality of life in a broad migraine population.”
 

Superior tolerability

Commenting on the study, Alan Rapoport, MD, clinical professor of neurology at the University of California, Los Angeles, and editor-in-chief of Neurology Reviews, said this is “a very important, very well conducted trial that documents what many of us already suspected; erenumab clearly has better tolerability than topiramate as well as better efficacy.”

Dr. Rapoport, a past president of the International Headache Society, said the study highlights an area of unmet need in neurology practice.

“Despite most patients in the trial having chronic headaches for 20 years, 60% of them had never received preventive treatment,” he said, noting that this reflects current practice in the United States.

Dr. Rapoport said primary care providers in the United States prescribe preventive migraine medications to 10%-15% of eligible patients. Prescribing rates for general neurologists are slightly higher, he said, ranging from 35% to 40%, while headache specialists prescribe 70%-90% of the time.

“How can we improve this situation?” Dr. Rapoport asked. “For years we have tried to improve it with education, but we need to do a better job. We need to educate our primary care physicians in more practical ways. We have to teach them how to make a diagnosis of high frequency migraine and chronic migraine and strongly suggest that those patients be put on appropriate preventive medications.”

Barriers to care may be systemic, according to Dr. Rapoport.

“One issue in the U.S. is that patients with commercial insurance are almost always required to fail two or three categories of older oral preventive migraine medications before they can get a monoclonal antibody or gepants for prevention,” he said. “It would be good if we could change that system so that patients that absolutely need the better tolerated, more effective preventive medications could get them sooner rather than later. This will help them feel and function better, with less pain, and eventually bring down the cost of migraine therapy.”

While Dr. Reuter and colleagues concluded that revised treatment sequencing may be warranted after more trials show similar results, Dr. Rapoport suggested that “this was such a large, well-performed, 6-month study with few dropouts, that further trials to confirm these findings are unnecessary, in my opinion.”

The HER-MES trial was funded by Novartis. Dr. Reuter and colleagues disclosed additional relationships with Eli Lilly, Teva Pharmaceutical, Allergan, and others. Dr. Rapoport was involved in early topiramate trials for prevention and migraine, and is a speaker for Amgen.

Erenumab, a calcitonin-gene related peptide receptor (CGRP) inhibitor, is more tolerable and effective than topiramate for treating patients with migraine, according to data from almost 800 patients in the first head-to-head trial of its kind.

The findings suggest that erenumab may help overcome longstanding issues with migraine medication adherence, and additional supportive data may alter treatment sequencing, reported lead author Uwe Reuter, MD, professor at Charité Universitätsmedizin Berlin, and colleagues.

“So far, no study has been done in order to compare the efficacy of a monoclonal antibody targeting the CGRP pathway to that of a standard of care oral preventive drug,” the investigators wrote in Cephalalgia.

The phase 4 HER-MES trial aimed to address this knowledge gap by enrolling 777 adult patients with a history of migraine. All patients reported migraine with or without aura for at least 1 year prior to screening. At baseline, most patients (65%) reported 8-14 migraine days per months, followed by 4-7 days (24.0%), and at least 15 days (11.0%). No patients had previously received topiramate or a CGRP-targeting agent.

“HER-MES includes a broad migraine population with two-thirds of the patients in the high-frequency migraine spectrum,” the investigators noted. “Despite a mean disease duration of about 20 years, almost 60% of the patients had not received previous prophylactic treatment, which underlines the long-standing problem of undertreatment in migraine.”

The trial had a double-dummy design; patients were randomized in a 1:1 ratio to receive either subcutaneous erenumab (70 or 140 mg/month) plus oral placebo, or oral topiramate (50-100 mg/day) plus subcutaneous placebo. The topiramate dose was uptitrated over the first 6 weeks. Treatments were given for a total of 24 weeks or until discontinuation due to adverse events, which was the primary endpoint. The secondary endpoint was efficacy over months 4-6, defined as at least 50% reduction in monthly migraine days, compared with baseline. Other patient-reported outcomes were also evaluated.

After 24 weeks, 95.1% of patients were still enrolled in the trial. Discontinuations due to adverse events were almost four times as common in the topiramate group than the erenumab group (38.9% vs. 10.6%; odds ratio [OR], 0.19; confidence interval, 0.13-0.27; P less than .001). Efficacy findings followed suit, with 55.4% of patients in the erenumab group reporting at least 50% reduction in monthly migraine days, compared with 31.2% of patients in the topiramate group (OR, 2.76; 95% CI, 2.06-3.71; P less than.001).

Erenumab significantly improved monthly migraine days, headache impact test (HIT-6) scores, and short form health survey version (SF-35v2) scores, including physical and mental components (P less than .001 for all).

Safety profiles aligned with previous findings.

“Compared to topiramate, treatment with erenumab has a superior tolerability profile and a significantly higher efficacy,” the investigators concluded. “HER-MES supports the potential of erenumab in overcoming issues of low adherence in clinical practice observed with topiramate, lessening migraine burden, and improving quality of life in a broad migraine population.”
 

Superior tolerability

Commenting on the study, Alan Rapoport, MD, clinical professor of neurology at the University of California, Los Angeles, and editor-in-chief of Neurology Reviews, said this is “a very important, very well conducted trial that documents what many of us already suspected; erenumab clearly has better tolerability than topiramate as well as better efficacy.”

Dr. Rapoport, a past president of the International Headache Society, said the study highlights an area of unmet need in neurology practice.

“Despite most patients in the trial having chronic headaches for 20 years, 60% of them had never received preventive treatment,” he said, noting that this reflects current practice in the United States.

Dr. Rapoport said primary care providers in the United States prescribe preventive migraine medications to 10%-15% of eligible patients. Prescribing rates for general neurologists are slightly higher, he said, ranging from 35% to 40%, while headache specialists prescribe 70%-90% of the time.

“How can we improve this situation?” Dr. Rapoport asked. “For years we have tried to improve it with education, but we need to do a better job. We need to educate our primary care physicians in more practical ways. We have to teach them how to make a diagnosis of high frequency migraine and chronic migraine and strongly suggest that those patients be put on appropriate preventive medications.”

Barriers to care may be systemic, according to Dr. Rapoport.

“One issue in the U.S. is that patients with commercial insurance are almost always required to fail two or three categories of older oral preventive migraine medications before they can get a monoclonal antibody or gepants for prevention,” he said. “It would be good if we could change that system so that patients that absolutely need the better tolerated, more effective preventive medications could get them sooner rather than later. This will help them feel and function better, with less pain, and eventually bring down the cost of migraine therapy.”

While Dr. Reuter and colleagues concluded that revised treatment sequencing may be warranted after more trials show similar results, Dr. Rapoport suggested that “this was such a large, well-performed, 6-month study with few dropouts, that further trials to confirm these findings are unnecessary, in my opinion.”

The HER-MES trial was funded by Novartis. Dr. Reuter and colleagues disclosed additional relationships with Eli Lilly, Teva Pharmaceutical, Allergan, and others. Dr. Rapoport was involved in early topiramate trials for prevention and migraine, and is a speaker for Amgen.

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.

Most cases of new daily persistent headache (NDPH) are moderate to severe and many feature characteristics often associated with migraine, according to a new retrospective chart review.

“Future prospective studies are needed to better understand this disabling disorder,” wrote Randolph W. Evans, MD, of Baylor College of Medicine of Houston, and Dana P. Turner, PhD, of Massachusetts General Hospital and Harvard Medical School in Boston. Their study was published Oct. 28 in Headache.

To categorize the infrequently reported clinical features of NDPH, the researchers launched a retrospective study of patients who were provisionally diagnosed with NDPH by Dr. Evans at an outpatient clinic in Houston from Sept. 1, 2011, to Feb. 28, 2020. Of the 328 patients whose diagnosis ultimately matched the ICHD-3 criteria, the average age at onset was 40.3 years (range 12-87 years). Approximately 70% were White, and nearly 66% were women. Two hundred and sixty were diagnosed with the migraine phenotype and 68 were diagnosed with the tension-type phenotype.
 

Key features

The median duration of NDPH at the time of the initial consult with Dr. Evans was 0.7 years, and it was 1.9 years at the time of the last visit. Almost 33% of patients with the migraine phenotype had a history of episodic migraine compared with 16.2% with the tension-type phenotype. Headaches were side-locked unilateral in 8.5% (n = 28) of all patients, and 3.6% (n = 12) had a thunderclap onset.

The most common clinical features across all patients included noise sensitivity (72.1%), light sensitivity (71%), moderate pain at the time of initial consult (57.9%), pressure pain (54.9%), and throbbing pain (50.9%). Nausea was reported in 157 patients and vomiting was reported in 48 patients, all of whom were in the migraine phenotype group. Thunderclap onset was far more prevalent in the migraine phenotype group (11 patients) compared with the tension-type phenotype group (1 patient), as was vertigo (19 patients compared with 1) and visual aura (21 compared with 0).

The top precipitating factors across all patients included stressful life events (20.4%), an antecedent upper respiratory infection or flu-like illness (10.1%), and antecedent extracranial surgery (1.5%). Exacerbating or aggravating factors were far more prevalent in the migraine phenotype group compared with the tension-type phenotype group, with stress (14.6% vs. 5.9%), bright or flashing light (10.4% vs. 1.5%), loud noise (8.5% vs. 0%), and lack of sleep (6.5% vs. 4.4%) leading the way.

The months with the most onsets were June (8.5%), January (7.6%), and February (7.6%); there was no clear seasonal or cyclical variation. The most common prognostic type across all patients was persisting (refractory) at 93%, followed by remitting (self-limiting) at 4.3% and relapsing-remitting at 2.7%.
 

Unlocking a medical mystery

“This is the largest case review study ever published on NDPH, especially because most people think it’s a fairly rare disorder when it’s actually not,” Herbert G. Markley, MD, of the New England Regional Headache Center in Worcester, Mass., said in an interview.

“The thing people need to understand is that they may have a lot of these patients in their practice and not realize it,” he added. “They keep trying one medication after another, and the patients are giving up, and the doctors are giving up. It’s terrible. We don’t know what causes it, and we don’t know how to treat it. It’s one of the biggest mysteries left in medical science.”

“My idea about this condition, and this is shared by others, is that NDPH is not a diagnosis that describes a cohesive group of patients but rather a group of people who share certain features,” Morris Levin, MD, director of the Headache Center at the University of California, San Francisco, said in an interview. “And they would be better served if this diagnosis was split into different categories.”

While praising Dr. Evans and Dr. Turner for their categorization and classification work, Dr. Levin asked, “Let’s say you diagnose someone with NDPH; does that in any way help you with management of this person? The answer is no. Some might say, ‘If you put the patients in the migraine phenotype group, then you can use migraine treatments.’ My point would be: then call it migraine.

“I believe another way to approach NDPH might be to create subcategories of migraine and tension-type headaches,” he added. “A migraine that is either intermittent or nonexistent suddenly becomes daily. That could be a subcategory; rather than being called NDPH, call it ‘new persistent chronic migraine.’ Or ‘new persistent chronic tension-type headache.’ Perhaps that would serve us better in terms of grasping the underlying mechanisms and the best treatment for these patients.”

Along the same lines, Dr. Markley echoed Dr. Evans’ call for more prospective studies and more research on possible medication, hoping to fuel further understanding of this debilitating disorder.

“I think this will be a landmark study for people to look back on,” he said, “especially for anyone going into the headache specialty who has never heard of this type of headache and keeps wondering why they can’t help certain patients, no matter how many medications they try.”

The authors acknowledged their study’s limitations, including its single-center nature and the data abstraction process being performed by just one person. They added, however, that Dr. Evans is a “very experienced researcher with more than 30 years of experience in headache medicine who was abstracting his own patients, data that were very familiar to him.”

Dr. Evans and Dr. Turner declared no potential conflicts of interest.

Most cases of new daily persistent headache (NDPH) are moderate to severe and many feature characteristics often associated with migraine, according to a new retrospective chart review.

“Future prospective studies are needed to better understand this disabling disorder,” wrote Randolph W. Evans, MD, of Baylor College of Medicine of Houston, and Dana P. Turner, PhD, of Massachusetts General Hospital and Harvard Medical School in Boston. Their study was published Oct. 28 in Headache.

To categorize the infrequently reported clinical features of NDPH, the researchers launched a retrospective study of patients who were provisionally diagnosed with NDPH by Dr. Evans at an outpatient clinic in Houston from Sept. 1, 2011, to Feb. 28, 2020. Of the 328 patients whose diagnosis ultimately matched the ICHD-3 criteria, the average age at onset was 40.3 years (range 12-87 years). Approximately 70% were White, and nearly 66% were women. Two hundred and sixty were diagnosed with the migraine phenotype and 68 were diagnosed with the tension-type phenotype.
 

Key features

The median duration of NDPH at the time of the initial consult with Dr. Evans was 0.7 years, and it was 1.9 years at the time of the last visit. Almost 33% of patients with the migraine phenotype had a history of episodic migraine compared with 16.2% with the tension-type phenotype. Headaches were side-locked unilateral in 8.5% (n = 28) of all patients, and 3.6% (n = 12) had a thunderclap onset.

The most common clinical features across all patients included noise sensitivity (72.1%), light sensitivity (71%), moderate pain at the time of initial consult (57.9%), pressure pain (54.9%), and throbbing pain (50.9%). Nausea was reported in 157 patients and vomiting was reported in 48 patients, all of whom were in the migraine phenotype group. Thunderclap onset was far more prevalent in the migraine phenotype group (11 patients) compared with the tension-type phenotype group (1 patient), as was vertigo (19 patients compared with 1) and visual aura (21 compared with 0).

The top precipitating factors across all patients included stressful life events (20.4%), an antecedent upper respiratory infection or flu-like illness (10.1%), and antecedent extracranial surgery (1.5%). Exacerbating or aggravating factors were far more prevalent in the migraine phenotype group compared with the tension-type phenotype group, with stress (14.6% vs. 5.9%), bright or flashing light (10.4% vs. 1.5%), loud noise (8.5% vs. 0%), and lack of sleep (6.5% vs. 4.4%) leading the way.

The months with the most onsets were June (8.5%), January (7.6%), and February (7.6%); there was no clear seasonal or cyclical variation. The most common prognostic type across all patients was persisting (refractory) at 93%, followed by remitting (self-limiting) at 4.3% and relapsing-remitting at 2.7%.
 

Unlocking a medical mystery

“This is the largest case review study ever published on NDPH, especially because most people think it’s a fairly rare disorder when it’s actually not,” Herbert G. Markley, MD, of the New England Regional Headache Center in Worcester, Mass., said in an interview.

“The thing people need to understand is that they may have a lot of these patients in their practice and not realize it,” he added. “They keep trying one medication after another, and the patients are giving up, and the doctors are giving up. It’s terrible. We don’t know what causes it, and we don’t know how to treat it. It’s one of the biggest mysteries left in medical science.”

“My idea about this condition, and this is shared by others, is that NDPH is not a diagnosis that describes a cohesive group of patients but rather a group of people who share certain features,” Morris Levin, MD, director of the Headache Center at the University of California, San Francisco, said in an interview. “And they would be better served if this diagnosis was split into different categories.”

While praising Dr. Evans and Dr. Turner for their categorization and classification work, Dr. Levin asked, “Let’s say you diagnose someone with NDPH; does that in any way help you with management of this person? The answer is no. Some might say, ‘If you put the patients in the migraine phenotype group, then you can use migraine treatments.’ My point would be: then call it migraine.

“I believe another way to approach NDPH might be to create subcategories of migraine and tension-type headaches,” he added. “A migraine that is either intermittent or nonexistent suddenly becomes daily. That could be a subcategory; rather than being called NDPH, call it ‘new persistent chronic migraine.’ Or ‘new persistent chronic tension-type headache.’ Perhaps that would serve us better in terms of grasping the underlying mechanisms and the best treatment for these patients.”

Along the same lines, Dr. Markley echoed Dr. Evans’ call for more prospective studies and more research on possible medication, hoping to fuel further understanding of this debilitating disorder.

“I think this will be a landmark study for people to look back on,” he said, “especially for anyone going into the headache specialty who has never heard of this type of headache and keeps wondering why they can’t help certain patients, no matter how many medications they try.”

The authors acknowledged their study’s limitations, including its single-center nature and the data abstraction process being performed by just one person. They added, however, that Dr. Evans is a “very experienced researcher with more than 30 years of experience in headache medicine who was abstracting his own patients, data that were very familiar to him.”

Dr. Evans and Dr. Turner declared no potential conflicts of interest.

Most cases of new daily persistent headache (NDPH) are moderate to severe and many feature characteristics often associated with migraine, according to a new retrospective chart review.

“Future prospective studies are needed to better understand this disabling disorder,” wrote Randolph W. Evans, MD, of Baylor College of Medicine of Houston, and Dana P. Turner, PhD, of Massachusetts General Hospital and Harvard Medical School in Boston. Their study was published Oct. 28 in Headache.

To categorize the infrequently reported clinical features of NDPH, the researchers launched a retrospective study of patients who were provisionally diagnosed with NDPH by Dr. Evans at an outpatient clinic in Houston from Sept. 1, 2011, to Feb. 28, 2020. Of the 328 patients whose diagnosis ultimately matched the ICHD-3 criteria, the average age at onset was 40.3 years (range 12-87 years). Approximately 70% were White, and nearly 66% were women. Two hundred and sixty were diagnosed with the migraine phenotype and 68 were diagnosed with the tension-type phenotype.
 

Key features

The median duration of NDPH at the time of the initial consult with Dr. Evans was 0.7 years, and it was 1.9 years at the time of the last visit. Almost 33% of patients with the migraine phenotype had a history of episodic migraine compared with 16.2% with the tension-type phenotype. Headaches were side-locked unilateral in 8.5% (n = 28) of all patients, and 3.6% (n = 12) had a thunderclap onset.

The most common clinical features across all patients included noise sensitivity (72.1%), light sensitivity (71%), moderate pain at the time of initial consult (57.9%), pressure pain (54.9%), and throbbing pain (50.9%). Nausea was reported in 157 patients and vomiting was reported in 48 patients, all of whom were in the migraine phenotype group. Thunderclap onset was far more prevalent in the migraine phenotype group (11 patients) compared with the tension-type phenotype group (1 patient), as was vertigo (19 patients compared with 1) and visual aura (21 compared with 0).

The top precipitating factors across all patients included stressful life events (20.4%), an antecedent upper respiratory infection or flu-like illness (10.1%), and antecedent extracranial surgery (1.5%). Exacerbating or aggravating factors were far more prevalent in the migraine phenotype group compared with the tension-type phenotype group, with stress (14.6% vs. 5.9%), bright or flashing light (10.4% vs. 1.5%), loud noise (8.5% vs. 0%), and lack of sleep (6.5% vs. 4.4%) leading the way.

The months with the most onsets were June (8.5%), January (7.6%), and February (7.6%); there was no clear seasonal or cyclical variation. The most common prognostic type across all patients was persisting (refractory) at 93%, followed by remitting (self-limiting) at 4.3% and relapsing-remitting at 2.7%.
 

Unlocking a medical mystery

“This is the largest case review study ever published on NDPH, especially because most people think it’s a fairly rare disorder when it’s actually not,” Herbert G. Markley, MD, of the New England Regional Headache Center in Worcester, Mass., said in an interview.

“The thing people need to understand is that they may have a lot of these patients in their practice and not realize it,” he added. “They keep trying one medication after another, and the patients are giving up, and the doctors are giving up. It’s terrible. We don’t know what causes it, and we don’t know how to treat it. It’s one of the biggest mysteries left in medical science.”

“My idea about this condition, and this is shared by others, is that NDPH is not a diagnosis that describes a cohesive group of patients but rather a group of people who share certain features,” Morris Levin, MD, director of the Headache Center at the University of California, San Francisco, said in an interview. “And they would be better served if this diagnosis was split into different categories.”

While praising Dr. Evans and Dr. Turner for their categorization and classification work, Dr. Levin asked, “Let’s say you diagnose someone with NDPH; does that in any way help you with management of this person? The answer is no. Some might say, ‘If you put the patients in the migraine phenotype group, then you can use migraine treatments.’ My point would be: then call it migraine.

“I believe another way to approach NDPH might be to create subcategories of migraine and tension-type headaches,” he added. “A migraine that is either intermittent or nonexistent suddenly becomes daily. That could be a subcategory; rather than being called NDPH, call it ‘new persistent chronic migraine.’ Or ‘new persistent chronic tension-type headache.’ Perhaps that would serve us better in terms of grasping the underlying mechanisms and the best treatment for these patients.”

Along the same lines, Dr. Markley echoed Dr. Evans’ call for more prospective studies and more research on possible medication, hoping to fuel further understanding of this debilitating disorder.

“I think this will be a landmark study for people to look back on,” he said, “especially for anyone going into the headache specialty who has never heard of this type of headache and keeps wondering why they can’t help certain patients, no matter how many medications they try.”

The authors acknowledged their study’s limitations, including its single-center nature and the data abstraction process being performed by just one person. They added, however, that Dr. Evans is a “very experienced researcher with more than 30 years of experience in headache medicine who was abstracting his own patients, data that were very familiar to him.”

Dr. Evans and Dr. Turner declared no potential conflicts of interest.

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.”

One of the stranger casualties of the COVID pandemic was my inpatient neurology career.

In the mid-90s, as a resident, I gave tissue plasminogen activator (tPA) one night to the first patient my institution registered in the study that got it approved by the Food and Drug Administration. Our director of stroke gave me a bottle of champagne the next day to thank me. That was where my career in acute inpatient neurology began.

Like many docs of my age, my hospital work has been dwindling with time, and was down to just 1-2 weekends a month in a small three-doc rotation. Not much, but it still made for some busy weekends.

The first wave of mass quarantining happened to fall just as our quarterly schedule was ending. In fact, I’d been working on writing it up for the next quarter when things began.

But then, in the course of a few days, one of us decided to retire early, and the other doc and I couldn’t agree on how to handle the rotation with only two people (somewhat naively, I told him the whole COVID thing would be over in 2-3 months; obviously I was WAY wrong).

So I finished up my last scheduled hospital call, figuring I’d be back in a few months.

So far that hasn’t happened. I’m now 17 months out since the last time I rounded on hospital patients.

And I don’t miss it at all.

This surprises me. I mean, we all start out, in medical school and residency, immersed in the hospital. It’s where the action is. Rounding, checking tests results, talking to patients, families, and nurses is ingrained into us. When I started in 1998 I hustled between four hospitals and enjoyed it (the work, not the driving).

Now I realize that my inpatient days are probably behind me, and I’m not bothered by it. That’s not to say I may not go back. Circumstances change, so, as before, I try to keep up on both inpatient and outpatient neurologic care and developments.

But for now, I’m happier without it. My weekends are my own. I don’t dread the Friday afternoon switchover where new consults suddenly start showing up on my cell phone. I don’t have to worry about running in at 2:00 a.m. to decide tPA or not tPA. My wife and I don’t have to take separate cars to go out to dinner, just in case I have to leave.

I’m sure I’ve lost some revenue because of it, but in the overall downturn of the pandemic it’s hard to know how much.

But I do know that I’ve gained time at home. With my wife, my kids, my dogs, and even just myself. My start and stop times on weekdays, and now plans for weekends, are now more predictable.

At some point those things are worth the money lost, and I’m happy to take them.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

One of the stranger casualties of the COVID pandemic was my inpatient neurology career.

In the mid-90s, as a resident, I gave tissue plasminogen activator (tPA) one night to the first patient my institution registered in the study that got it approved by the Food and Drug Administration. Our director of stroke gave me a bottle of champagne the next day to thank me. That was where my career in acute inpatient neurology began.

Like many docs of my age, my hospital work has been dwindling with time, and was down to just 1-2 weekends a month in a small three-doc rotation. Not much, but it still made for some busy weekends.

The first wave of mass quarantining happened to fall just as our quarterly schedule was ending. In fact, I’d been working on writing it up for the next quarter when things began.

But then, in the course of a few days, one of us decided to retire early, and the other doc and I couldn’t agree on how to handle the rotation with only two people (somewhat naively, I told him the whole COVID thing would be over in 2-3 months; obviously I was WAY wrong).

So I finished up my last scheduled hospital call, figuring I’d be back in a few months.

So far that hasn’t happened. I’m now 17 months out since the last time I rounded on hospital patients.

And I don’t miss it at all.

This surprises me. I mean, we all start out, in medical school and residency, immersed in the hospital. It’s where the action is. Rounding, checking tests results, talking to patients, families, and nurses is ingrained into us. When I started in 1998 I hustled between four hospitals and enjoyed it (the work, not the driving).

Now I realize that my inpatient days are probably behind me, and I’m not bothered by it. That’s not to say I may not go back. Circumstances change, so, as before, I try to keep up on both inpatient and outpatient neurologic care and developments.

But for now, I’m happier without it. My weekends are my own. I don’t dread the Friday afternoon switchover where new consults suddenly start showing up on my cell phone. I don’t have to worry about running in at 2:00 a.m. to decide tPA or not tPA. My wife and I don’t have to take separate cars to go out to dinner, just in case I have to leave.

I’m sure I’ve lost some revenue because of it, but in the overall downturn of the pandemic it’s hard to know how much.

But I do know that I’ve gained time at home. With my wife, my kids, my dogs, and even just myself. My start and stop times on weekdays, and now plans for weekends, are now more predictable.

At some point those things are worth the money lost, and I’m happy to take them.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

One of the stranger casualties of the COVID pandemic was my inpatient neurology career.

In the mid-90s, as a resident, I gave tissue plasminogen activator (tPA) one night to the first patient my institution registered in the study that got it approved by the Food and Drug Administration. Our director of stroke gave me a bottle of champagne the next day to thank me. That was where my career in acute inpatient neurology began.

Like many docs of my age, my hospital work has been dwindling with time, and was down to just 1-2 weekends a month in a small three-doc rotation. Not much, but it still made for some busy weekends.

The first wave of mass quarantining happened to fall just as our quarterly schedule was ending. In fact, I’d been working on writing it up for the next quarter when things began.

But then, in the course of a few days, one of us decided to retire early, and the other doc and I couldn’t agree on how to handle the rotation with only two people (somewhat naively, I told him the whole COVID thing would be over in 2-3 months; obviously I was WAY wrong).

So I finished up my last scheduled hospital call, figuring I’d be back in a few months.

So far that hasn’t happened. I’m now 17 months out since the last time I rounded on hospital patients.

And I don’t miss it at all.

This surprises me. I mean, we all start out, in medical school and residency, immersed in the hospital. It’s where the action is. Rounding, checking tests results, talking to patients, families, and nurses is ingrained into us. When I started in 1998 I hustled between four hospitals and enjoyed it (the work, not the driving).

Now I realize that my inpatient days are probably behind me, and I’m not bothered by it. That’s not to say I may not go back. Circumstances change, so, as before, I try to keep up on both inpatient and outpatient neurologic care and developments.

But for now, I’m happier without it. My weekends are my own. I don’t dread the Friday afternoon switchover where new consults suddenly start showing up on my cell phone. I don’t have to worry about running in at 2:00 a.m. to decide tPA or not tPA. My wife and I don’t have to take separate cars to go out to dinner, just in case I have to leave.

I’m sure I’ve lost some revenue because of it, but in the overall downturn of the pandemic it’s hard to know how much.

But I do know that I’ve gained time at home. With my wife, my kids, my dogs, and even just myself. My start and stop times on weekdays, and now plans for weekends, are now more predictable.

At some point those things are worth the money lost, and I’m happy to take them.

Dr. Block has a solo neurology practice in Scottsdale, Ariz.

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.

The experimental monoclonal antibody bentracimab, which reverses the antiplatelet effects of ticagrelor, appears to be heading toward regulatory approval, on the basis of an interim analysis of the phase 3 REVERSE-IT trial.

“Rates of effective hemostasis were adjudicated as good or excellent in more than 90% of cases with no drug-related serious adverse events or allergic or infusion-related reactions,” reported Deepak L. Bhatt, MD, at the American Heart Association scientific sessions.

The interim analysis of this nonrandomized, single-arm study was requested by the Food and Drug Administration, which is considering a conditional accelerated approval of bentracimab (formerly PB2452) if efficacy and safety are established.

Upon administration, bentracimab binds to free ticagrelor so that ticagrelor cannot bind to the P2Y12 platelet receptor. This interrupts one of the key steps in the pathway of platelet aggregation.

REVERSE-IT is still enrolling patients. This interim analysis was conducted with the first 150 patients who met eligibility criteria and were treated. Of these, 142 patients were enrolled for an urgent surgical indication and 8 for a major bleeding indication. After some exclusions for lack of urgency and reclassifications following adjudication, there were 113 surgical cases and 9 major bleeding patients evaluable for hemostasis.
 

Platelet function assays test reversal

On the primary reversal endpoint, which was restoration of activity on the proprietary platelet function assays Verify Now and PRUTest, a rapid restoration of platelet function was achieved in both surgical and major-bleeding patients. Platelet reactivity climbed to near normal levels within 10 minutes of administration, and peak effects were sustained through the first 24 hours after administration.

On the basis of the platelet function assays, the pattern of response to bentracimab was “very similar in the surgical and bleeding patients,” reported Dr. Bhatt, executive director of interventional cardiovascular programs at Brigham and Women’s Health, Boston.

The effect was also consistent across a broad array of prespecified subgroups, including stratifications by age, renal function, time from last dose of ticagrelor, race, and the presence of comorbidities, such as diabetes, renal dysfunction, hypertension, and history of MI.
 

Hemostasis documented in all but one patient

Adjudicated hemostasis was achieved in 100% of the 113 urgent surgical patients evaluated. In the nine major bleeding patients, six achieved excellent hemostasis and one achieved good hemostasis. One had poor hemostasis, and one was unevaluable.

Platelet rebound following bentracimab administration, measured by mean platelet volume, was not observed.

There were no serious adverse events, allergic reactions, or serious infusion-related reactions associated with the administration of bentracimab, Dr. Bhatt said.

While Dr. Bhatt acknowledged that the number of patients in the major-bleeding subgroup was small, he noted that the reduction in platelet reactivity relative to baseline was still significant. In addition, he characterized urgent surgery as “an excellent model of bleeding” and pointed out the consistency of results in the surgical and major-bleeding groups.

The interim results are also consistent with phase 1 data published 2 years ago, and with the subsequent phase 2 studies. All of these data are now under regulatory review both in the United States and in Europe, according to Dr. Bhatt.
 

No good current options for reversal

Evidence of efficacy and safety is encouraging, because current options for urgently reversing ticagrelor are “disappointing,” according to the invited discussant Gilles Montalescot, MD, PhD, professor of cardiology, Pitié-Salpêtrière Hôpital, Paris.

“Platelet transfusion has some value for clopidogrel and prasugrel, but it does not work for ticagrelor,” said Dr. Montalescot, referring to two other P2Y12 inhibitors. Substantiating the need for a reversal agent, he identified several other strategies that have proven ineffective, such as desmopressin and sorbent hemadsorption.

Overall, Dr. Montalescot acknowledged the need for a highly effective ticagrelor reversal agent, but he did have some criticisms of REVERSE-IT. For one, he was not convinced about the design.

“What was unethical in having a control group?” he asked, suggesting that it was feasible and would have addressed issues of relative efficacy and safety.

For example, the authors concluded that none of the thrombotic events were likely to be treatment related, but “four events occurred immediately after reversal without an alternate explanation,” Dr. Montalescot pointed out. “Was this a signal or background noise?”

Nevertheless, he agreed that the interim phase 3 data are consistent with the previously reported phase 2 studies, and he reiterated that a strategy to reverse ticagrelor’s effects is an important unmet need.

Dr. Bhatt has a financial relationship with a large number of pharmaceutical companies, including PhaseBio, which provided funding for the REVERSE-IT trial. Dr. Montalescot reported financial relationships with Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Boston Scientific, Bristol-Myers Squibb, Cell-Prothera, CSL-Behring, Europa, Idorsia, Servicer, Medtronic, Merck Sharpe & Dohme, Novartis, Pfizer, Quantum Genomics, and Sanofi-Aventis.
 

The experimental monoclonal antibody bentracimab, which reverses the antiplatelet effects of ticagrelor, appears to be heading toward regulatory approval, on the basis of an interim analysis of the phase 3 REVERSE-IT trial.

“Rates of effective hemostasis were adjudicated as good or excellent in more than 90% of cases with no drug-related serious adverse events or allergic or infusion-related reactions,” reported Deepak L. Bhatt, MD, at the American Heart Association scientific sessions.

The interim analysis of this nonrandomized, single-arm study was requested by the Food and Drug Administration, which is considering a conditional accelerated approval of bentracimab (formerly PB2452) if efficacy and safety are established.

Upon administration, bentracimab binds to free ticagrelor so that ticagrelor cannot bind to the P2Y12 platelet receptor. This interrupts one of the key steps in the pathway of platelet aggregation.

REVERSE-IT is still enrolling patients. This interim analysis was conducted with the first 150 patients who met eligibility criteria and were treated. Of these, 142 patients were enrolled for an urgent surgical indication and 8 for a major bleeding indication. After some exclusions for lack of urgency and reclassifications following adjudication, there were 113 surgical cases and 9 major bleeding patients evaluable for hemostasis.
 

Platelet function assays test reversal

On the primary reversal endpoint, which was restoration of activity on the proprietary platelet function assays Verify Now and PRUTest, a rapid restoration of platelet function was achieved in both surgical and major-bleeding patients. Platelet reactivity climbed to near normal levels within 10 minutes of administration, and peak effects were sustained through the first 24 hours after administration.

On the basis of the platelet function assays, the pattern of response to bentracimab was “very similar in the surgical and bleeding patients,” reported Dr. Bhatt, executive director of interventional cardiovascular programs at Brigham and Women’s Health, Boston.

The effect was also consistent across a broad array of prespecified subgroups, including stratifications by age, renal function, time from last dose of ticagrelor, race, and the presence of comorbidities, such as diabetes, renal dysfunction, hypertension, and history of MI.
 

Hemostasis documented in all but one patient

Adjudicated hemostasis was achieved in 100% of the 113 urgent surgical patients evaluated. In the nine major bleeding patients, six achieved excellent hemostasis and one achieved good hemostasis. One had poor hemostasis, and one was unevaluable.

Platelet rebound following bentracimab administration, measured by mean platelet volume, was not observed.

There were no serious adverse events, allergic reactions, or serious infusion-related reactions associated with the administration of bentracimab, Dr. Bhatt said.

While Dr. Bhatt acknowledged that the number of patients in the major-bleeding subgroup was small, he noted that the reduction in platelet reactivity relative to baseline was still significant. In addition, he characterized urgent surgery as “an excellent model of bleeding” and pointed out the consistency of results in the surgical and major-bleeding groups.

The interim results are also consistent with phase 1 data published 2 years ago, and with the subsequent phase 2 studies. All of these data are now under regulatory review both in the United States and in Europe, according to Dr. Bhatt.
 

No good current options for reversal

Evidence of efficacy and safety is encouraging, because current options for urgently reversing ticagrelor are “disappointing,” according to the invited discussant Gilles Montalescot, MD, PhD, professor of cardiology, Pitié-Salpêtrière Hôpital, Paris.

“Platelet transfusion has some value for clopidogrel and prasugrel, but it does not work for ticagrelor,” said Dr. Montalescot, referring to two other P2Y12 inhibitors. Substantiating the need for a reversal agent, he identified several other strategies that have proven ineffective, such as desmopressin and sorbent hemadsorption.

Overall, Dr. Montalescot acknowledged the need for a highly effective ticagrelor reversal agent, but he did have some criticisms of REVERSE-IT. For one, he was not convinced about the design.

“What was unethical in having a control group?” he asked, suggesting that it was feasible and would have addressed issues of relative efficacy and safety.

For example, the authors concluded that none of the thrombotic events were likely to be treatment related, but “four events occurred immediately after reversal without an alternate explanation,” Dr. Montalescot pointed out. “Was this a signal or background noise?”

Nevertheless, he agreed that the interim phase 3 data are consistent with the previously reported phase 2 studies, and he reiterated that a strategy to reverse ticagrelor’s effects is an important unmet need.

Dr. Bhatt has a financial relationship with a large number of pharmaceutical companies, including PhaseBio, which provided funding for the REVERSE-IT trial. Dr. Montalescot reported financial relationships with Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Boston Scientific, Bristol-Myers Squibb, Cell-Prothera, CSL-Behring, Europa, Idorsia, Servicer, Medtronic, Merck Sharpe & Dohme, Novartis, Pfizer, Quantum Genomics, and Sanofi-Aventis.
 

The experimental monoclonal antibody bentracimab, which reverses the antiplatelet effects of ticagrelor, appears to be heading toward regulatory approval, on the basis of an interim analysis of the phase 3 REVERSE-IT trial.

“Rates of effective hemostasis were adjudicated as good or excellent in more than 90% of cases with no drug-related serious adverse events or allergic or infusion-related reactions,” reported Deepak L. Bhatt, MD, at the American Heart Association scientific sessions.

The interim analysis of this nonrandomized, single-arm study was requested by the Food and Drug Administration, which is considering a conditional accelerated approval of bentracimab (formerly PB2452) if efficacy and safety are established.

Upon administration, bentracimab binds to free ticagrelor so that ticagrelor cannot bind to the P2Y12 platelet receptor. This interrupts one of the key steps in the pathway of platelet aggregation.

REVERSE-IT is still enrolling patients. This interim analysis was conducted with the first 150 patients who met eligibility criteria and were treated. Of these, 142 patients were enrolled for an urgent surgical indication and 8 for a major bleeding indication. After some exclusions for lack of urgency and reclassifications following adjudication, there were 113 surgical cases and 9 major bleeding patients evaluable for hemostasis.
 

Platelet function assays test reversal

On the primary reversal endpoint, which was restoration of activity on the proprietary platelet function assays Verify Now and PRUTest, a rapid restoration of platelet function was achieved in both surgical and major-bleeding patients. Platelet reactivity climbed to near normal levels within 10 minutes of administration, and peak effects were sustained through the first 24 hours after administration.

On the basis of the platelet function assays, the pattern of response to bentracimab was “very similar in the surgical and bleeding patients,” reported Dr. Bhatt, executive director of interventional cardiovascular programs at Brigham and Women’s Health, Boston.

The effect was also consistent across a broad array of prespecified subgroups, including stratifications by age, renal function, time from last dose of ticagrelor, race, and the presence of comorbidities, such as diabetes, renal dysfunction, hypertension, and history of MI.
 

Hemostasis documented in all but one patient

Adjudicated hemostasis was achieved in 100% of the 113 urgent surgical patients evaluated. In the nine major bleeding patients, six achieved excellent hemostasis and one achieved good hemostasis. One had poor hemostasis, and one was unevaluable.

Platelet rebound following bentracimab administration, measured by mean platelet volume, was not observed.

There were no serious adverse events, allergic reactions, or serious infusion-related reactions associated with the administration of bentracimab, Dr. Bhatt said.

While Dr. Bhatt acknowledged that the number of patients in the major-bleeding subgroup was small, he noted that the reduction in platelet reactivity relative to baseline was still significant. In addition, he characterized urgent surgery as “an excellent model of bleeding” and pointed out the consistency of results in the surgical and major-bleeding groups.

The interim results are also consistent with phase 1 data published 2 years ago, and with the subsequent phase 2 studies. All of these data are now under regulatory review both in the United States and in Europe, according to Dr. Bhatt.
 

No good current options for reversal

Evidence of efficacy and safety is encouraging, because current options for urgently reversing ticagrelor are “disappointing,” according to the invited discussant Gilles Montalescot, MD, PhD, professor of cardiology, Pitié-Salpêtrière Hôpital, Paris.

“Platelet transfusion has some value for clopidogrel and prasugrel, but it does not work for ticagrelor,” said Dr. Montalescot, referring to two other P2Y12 inhibitors. Substantiating the need for a reversal agent, he identified several other strategies that have proven ineffective, such as desmopressin and sorbent hemadsorption.

Overall, Dr. Montalescot acknowledged the need for a highly effective ticagrelor reversal agent, but he did have some criticisms of REVERSE-IT. For one, he was not convinced about the design.

“What was unethical in having a control group?” he asked, suggesting that it was feasible and would have addressed issues of relative efficacy and safety.

For example, the authors concluded that none of the thrombotic events were likely to be treatment related, but “four events occurred immediately after reversal without an alternate explanation,” Dr. Montalescot pointed out. “Was this a signal or background noise?”

Nevertheless, he agreed that the interim phase 3 data are consistent with the previously reported phase 2 studies, and he reiterated that a strategy to reverse ticagrelor’s effects is an important unmet need.

Dr. Bhatt has a financial relationship with a large number of pharmaceutical companies, including PhaseBio, which provided funding for the REVERSE-IT trial. Dr. Montalescot reported financial relationships with Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Boston Scientific, Bristol-Myers Squibb, Cell-Prothera, CSL-Behring, Europa, Idorsia, Servicer, Medtronic, Merck Sharpe & Dohme, Novartis, Pfizer, Quantum Genomics, and Sanofi-Aventis.