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Mifepristone freed of restrictions for the pandemic

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Tue, 08/24/2021 - 10:43

Since evidence shows that medication abortion is extremely safe, why is mifepristone so restricted? And should it be? Mifepristone, used with misoprostol for medication abortion for pregnancies up to 10 weeks’ gestation, is highly regulated in the United States. Going back to 2000, when the Food and Drug Administration approved Mifeprex (brand name of mifepristone), its access was restricted under the FDA Risk Evaluation and Mitigation Strategy (REMS).

Dr. Lindsay Dale

REMS is an FDA drug safety program, where certain medications with serious safety concerns are subject to restrictions intended to ensure that the benefits of the medication outweigh its risks. For example, the drug vigabatrin, with a side effect of permanent vision loss, is used to treat epilepsy. The REMS for vigabatrin requires counseling on the risk of vision loss and periodic vision monitoring.

The FDA claims that rare side effects of mifepristone – heavy vaginal bleeding, severe infection, and incomplete abortion – are risks that warrant the REMS, despite the known safety of medication abortion, with less than 1% of patients requiring emergency intervention for heavy vaginal bleeding or infection. The mifepristone REMS requires that the drug is dispensed in a hospital, clinic or medical office by a certified health care provider and not in a pharmacy as is the case with most prescribed medications, and that patients must read and sign the patient agreement form in the physical presence of the dispensing physician and may not receive counseling via telemedicine, for example.

Dr. Patricia Black

Since FDA approval over 20 years ago, much evidence shows that the REMS is unnecessary and creates a major obstacle to access. Many clinicians cannot meet the REMS requirements. Many women must travel great distances to obtain mifepristone or delay their abortion past the acceptable gestational age for medication abortion.

In spring 2020, at the onset of the COVID-19 pandemic, the Centers for Disease Control and Prevention issued general guidance recommending use of telemedicine to limit in-person medical visits to reduce risk of exposure to the SARS-CoV-2 virus, and to ensure access to medication abortion, the ACLU filed a federal lawsuit against the FDA to suspend the requirement for in-person mifepristone dispensing. In July 2020, a Maryland District Judge granted a preliminary injunction, preventing the FDA from enforcing the in-person dispensing requirement for the duration of the declared public health emergency, allowing telemedicine medication abortion using mail or delivery service for administration of mifepristone. All other REMS requirements remained in effect.

In January 2021, the FDA appealed, seeking to reinstate the REMS. The U.S. Supreme Court, with its conservative majority, ruled to reimpose the REMS. Following this decision, a large coalition of reproductive rights groups petitioned the Biden administration to suspend the mifepristone in-person requirement during the public health emergency of the pandemic. In April 2021, the FDA announced it would use discretion and cease to enforce the in-person dispensing requirement throughout the remainder of the public health emergency.

Dr. Eve Espey

We applaud the FDA for doing the right thing, taking the advice of numerous scientific and advocacy groups to expand access to mifepristone by at least temporarily nullifying unnecessary and burdensome restrictions that disproportionately affect people of color; young people; and people who live in rural areas, have lower incomes, and/or who are undocumented. We join the voices of numerous colleagues and organizations, including the American College of Obstetricians and Gynecologists, our premier women’s health organization, in calling for a permanent end to the mifepristone REMS.

Dr. Dale is an obstetrics and gynecology specialist in Albuquerque, N.M.; Dr. Black is an obstetrics and gynecology specialist in Albuquerque, N.M., who currently practices at the University of New Mexico Children’s Psychiatric Center, Albuquerque; and Dr. Espey is professor and chair of the department of ob.gyn. and family planning, and fellowship director at the University of New Mexico, Albuquerque.

This article was updated 8/24/21.

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Since evidence shows that medication abortion is extremely safe, why is mifepristone so restricted? And should it be? Mifepristone, used with misoprostol for medication abortion for pregnancies up to 10 weeks’ gestation, is highly regulated in the United States. Going back to 2000, when the Food and Drug Administration approved Mifeprex (brand name of mifepristone), its access was restricted under the FDA Risk Evaluation and Mitigation Strategy (REMS).

Dr. Lindsay Dale

REMS is an FDA drug safety program, where certain medications with serious safety concerns are subject to restrictions intended to ensure that the benefits of the medication outweigh its risks. For example, the drug vigabatrin, with a side effect of permanent vision loss, is used to treat epilepsy. The REMS for vigabatrin requires counseling on the risk of vision loss and periodic vision monitoring.

The FDA claims that rare side effects of mifepristone – heavy vaginal bleeding, severe infection, and incomplete abortion – are risks that warrant the REMS, despite the known safety of medication abortion, with less than 1% of patients requiring emergency intervention for heavy vaginal bleeding or infection. The mifepristone REMS requires that the drug is dispensed in a hospital, clinic or medical office by a certified health care provider and not in a pharmacy as is the case with most prescribed medications, and that patients must read and sign the patient agreement form in the physical presence of the dispensing physician and may not receive counseling via telemedicine, for example.

Dr. Patricia Black

Since FDA approval over 20 years ago, much evidence shows that the REMS is unnecessary and creates a major obstacle to access. Many clinicians cannot meet the REMS requirements. Many women must travel great distances to obtain mifepristone or delay their abortion past the acceptable gestational age for medication abortion.

In spring 2020, at the onset of the COVID-19 pandemic, the Centers for Disease Control and Prevention issued general guidance recommending use of telemedicine to limit in-person medical visits to reduce risk of exposure to the SARS-CoV-2 virus, and to ensure access to medication abortion, the ACLU filed a federal lawsuit against the FDA to suspend the requirement for in-person mifepristone dispensing. In July 2020, a Maryland District Judge granted a preliminary injunction, preventing the FDA from enforcing the in-person dispensing requirement for the duration of the declared public health emergency, allowing telemedicine medication abortion using mail or delivery service for administration of mifepristone. All other REMS requirements remained in effect.

In January 2021, the FDA appealed, seeking to reinstate the REMS. The U.S. Supreme Court, with its conservative majority, ruled to reimpose the REMS. Following this decision, a large coalition of reproductive rights groups petitioned the Biden administration to suspend the mifepristone in-person requirement during the public health emergency of the pandemic. In April 2021, the FDA announced it would use discretion and cease to enforce the in-person dispensing requirement throughout the remainder of the public health emergency.

Dr. Eve Espey

We applaud the FDA for doing the right thing, taking the advice of numerous scientific and advocacy groups to expand access to mifepristone by at least temporarily nullifying unnecessary and burdensome restrictions that disproportionately affect people of color; young people; and people who live in rural areas, have lower incomes, and/or who are undocumented. We join the voices of numerous colleagues and organizations, including the American College of Obstetricians and Gynecologists, our premier women’s health organization, in calling for a permanent end to the mifepristone REMS.

Dr. Dale is an obstetrics and gynecology specialist in Albuquerque, N.M.; Dr. Black is an obstetrics and gynecology specialist in Albuquerque, N.M., who currently practices at the University of New Mexico Children’s Psychiatric Center, Albuquerque; and Dr. Espey is professor and chair of the department of ob.gyn. and family planning, and fellowship director at the University of New Mexico, Albuquerque.

This article was updated 8/24/21.

Since evidence shows that medication abortion is extremely safe, why is mifepristone so restricted? And should it be? Mifepristone, used with misoprostol for medication abortion for pregnancies up to 10 weeks’ gestation, is highly regulated in the United States. Going back to 2000, when the Food and Drug Administration approved Mifeprex (brand name of mifepristone), its access was restricted under the FDA Risk Evaluation and Mitigation Strategy (REMS).

Dr. Lindsay Dale

REMS is an FDA drug safety program, where certain medications with serious safety concerns are subject to restrictions intended to ensure that the benefits of the medication outweigh its risks. For example, the drug vigabatrin, with a side effect of permanent vision loss, is used to treat epilepsy. The REMS for vigabatrin requires counseling on the risk of vision loss and periodic vision monitoring.

The FDA claims that rare side effects of mifepristone – heavy vaginal bleeding, severe infection, and incomplete abortion – are risks that warrant the REMS, despite the known safety of medication abortion, with less than 1% of patients requiring emergency intervention for heavy vaginal bleeding or infection. The mifepristone REMS requires that the drug is dispensed in a hospital, clinic or medical office by a certified health care provider and not in a pharmacy as is the case with most prescribed medications, and that patients must read and sign the patient agreement form in the physical presence of the dispensing physician and may not receive counseling via telemedicine, for example.

Dr. Patricia Black

Since FDA approval over 20 years ago, much evidence shows that the REMS is unnecessary and creates a major obstacle to access. Many clinicians cannot meet the REMS requirements. Many women must travel great distances to obtain mifepristone or delay their abortion past the acceptable gestational age for medication abortion.

In spring 2020, at the onset of the COVID-19 pandemic, the Centers for Disease Control and Prevention issued general guidance recommending use of telemedicine to limit in-person medical visits to reduce risk of exposure to the SARS-CoV-2 virus, and to ensure access to medication abortion, the ACLU filed a federal lawsuit against the FDA to suspend the requirement for in-person mifepristone dispensing. In July 2020, a Maryland District Judge granted a preliminary injunction, preventing the FDA from enforcing the in-person dispensing requirement for the duration of the declared public health emergency, allowing telemedicine medication abortion using mail or delivery service for administration of mifepristone. All other REMS requirements remained in effect.

In January 2021, the FDA appealed, seeking to reinstate the REMS. The U.S. Supreme Court, with its conservative majority, ruled to reimpose the REMS. Following this decision, a large coalition of reproductive rights groups petitioned the Biden administration to suspend the mifepristone in-person requirement during the public health emergency of the pandemic. In April 2021, the FDA announced it would use discretion and cease to enforce the in-person dispensing requirement throughout the remainder of the public health emergency.

Dr. Eve Espey

We applaud the FDA for doing the right thing, taking the advice of numerous scientific and advocacy groups to expand access to mifepristone by at least temporarily nullifying unnecessary and burdensome restrictions that disproportionately affect people of color; young people; and people who live in rural areas, have lower incomes, and/or who are undocumented. We join the voices of numerous colleagues and organizations, including the American College of Obstetricians and Gynecologists, our premier women’s health organization, in calling for a permanent end to the mifepristone REMS.

Dr. Dale is an obstetrics and gynecology specialist in Albuquerque, N.M.; Dr. Black is an obstetrics and gynecology specialist in Albuquerque, N.M., who currently practices at the University of New Mexico Children’s Psychiatric Center, Albuquerque; and Dr. Espey is professor and chair of the department of ob.gyn. and family planning, and fellowship director at the University of New Mexico, Albuquerque.

This article was updated 8/24/21.

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FDA fully approves Pfizer COVID-19 vaccine

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Mon, 08/30/2021 - 10:11

 

The Food and Drug Administration has granted a biological license application, more commonly known as “full approval,” to the Pfizer-BioNTech COVID-19 vaccine.

It is the first COVID-19 vaccine to be fully licensed in the United States. It will be marketed under the trade name Comirnaty. 

The approval applies to individuals ages 16 years and older. The vaccine is still available for emergency use for those ages 12-15.

The FDA’s stamp of approval is somewhat anticlimactic, following months of real-world use and millions of doses doled out to the general population. It comes after months of scrutiny by the agency of the clinical trial data.

Still, the approval puts the vaccines on firmer legal footing and is expected to spur a raft of new vaccination requirements by employers, schools, and universities. 

“The FDA approval is the gold standard,” President Joe Biden said from the White House. “Those who have been waiting for full approval should go and get your shot now.”

“It could save your life or the lives of those you love,” he said.

Biden also called on businesses to mandate COVID vaccines for their employees.

Indeed, soon after the approval was announced, Defense Secretary Lloyd Austin said the vaccines would be required for all 1.4 million active duty service members.


Public health advocates have seen full approval as an important tool to increase U.S. vaccination rates and had criticized the FDA for taking so long to grant the license. 

In a news briefing on the approval, Peter Marks, MD, director of the FDA’s Center for Biologics Evaluation and Research, said the agency had not dragged its feet.

Marks noted that his team had reviewed tens of thousands of pages of clinical trial data -- down to the level of individual patients. They also inspected clinical trial sites and manufacturing facilities, and reviewed information gathered after the vaccines were authorized for use.

“It’s been 97 days since Pfizer completed the role of its [application for approval] and the clock started, which means that we completed this in about 40% of the normal clock time for a submission of this magnitude,” he said. “People worked day and night.”

The agency resisted pressure to speed up its process, saying a thorough review was necessary to ensure public confidence.

“While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated. Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.,” acting FDA Commissioner Janet Woodcock said in a FDA news release.

Experts agreed the move would increase public confidence.

 “I don't expect a big line outside of vaccination sites this afternoon or tomorrow morning, but it will persuade some,” said William Schaffner, MD, a professor of infectious diseases at Vanderbilt University in Nashville.

A recent Kaiser Family Foundation poll found that 3 in 10 unvaccinated adults said they would be more likely to get vaccinated if the vaccines were given full approval.

More importantly, Schaffner said, the FDA’s approval would lay the groundwork for vaccine mandates. “I think those kinds of mandates are going to be necessary to get us up over 80% vaccinated.”

In granting the approval, the agency reviewed a record amount of data from more than 40,000 people who took part in clinical trials. About 12,000 recipients have been followed for at least 6 months, the agency said.

The FDA also reviewed safety data collected since it issued its emergency use authorization for the shots in December.

Based on the results from the clinical trials, the vaccine was 91% effective at preventing COVID-19 disease. But that estimate came from data collected before the Delta variant became widespread.

The most commonly reported side effects in the clinical trials were pain, redness and swelling at the injection site, fatigue, headache, muscle or joint pain, chills, and fever.

The FDA said the vaccine is effective in preventing COVID-19 and potentially serious outcomes, including hospitalization and death.

Based on safety data reviewed since the two-dose vaccine was approved, the FDA said the data demonstrates a higher risk for heart inflammation -- clinically known as myocarditis or pericarditis -- especially within 7 days after the second dose of the shots. The risk is highest for men under age 40, compared to women and older men.

The prescription information includes warnings about these risks. The FDA said the drugmakers must continue to study the risks and long-term effects on people who have myocarditis after vaccination.

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

This article was updated on 8/24/21.

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The Food and Drug Administration has granted a biological license application, more commonly known as “full approval,” to the Pfizer-BioNTech COVID-19 vaccine.

It is the first COVID-19 vaccine to be fully licensed in the United States. It will be marketed under the trade name Comirnaty. 

The approval applies to individuals ages 16 years and older. The vaccine is still available for emergency use for those ages 12-15.

The FDA’s stamp of approval is somewhat anticlimactic, following months of real-world use and millions of doses doled out to the general population. It comes after months of scrutiny by the agency of the clinical trial data.

Still, the approval puts the vaccines on firmer legal footing and is expected to spur a raft of new vaccination requirements by employers, schools, and universities. 

“The FDA approval is the gold standard,” President Joe Biden said from the White House. “Those who have been waiting for full approval should go and get your shot now.”

“It could save your life or the lives of those you love,” he said.

Biden also called on businesses to mandate COVID vaccines for their employees.

Indeed, soon after the approval was announced, Defense Secretary Lloyd Austin said the vaccines would be required for all 1.4 million active duty service members.


Public health advocates have seen full approval as an important tool to increase U.S. vaccination rates and had criticized the FDA for taking so long to grant the license. 

In a news briefing on the approval, Peter Marks, MD, director of the FDA’s Center for Biologics Evaluation and Research, said the agency had not dragged its feet.

Marks noted that his team had reviewed tens of thousands of pages of clinical trial data -- down to the level of individual patients. They also inspected clinical trial sites and manufacturing facilities, and reviewed information gathered after the vaccines were authorized for use.

“It’s been 97 days since Pfizer completed the role of its [application for approval] and the clock started, which means that we completed this in about 40% of the normal clock time for a submission of this magnitude,” he said. “People worked day and night.”

The agency resisted pressure to speed up its process, saying a thorough review was necessary to ensure public confidence.

“While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated. Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.,” acting FDA Commissioner Janet Woodcock said in a FDA news release.

Experts agreed the move would increase public confidence.

 “I don't expect a big line outside of vaccination sites this afternoon or tomorrow morning, but it will persuade some,” said William Schaffner, MD, a professor of infectious diseases at Vanderbilt University in Nashville.

A recent Kaiser Family Foundation poll found that 3 in 10 unvaccinated adults said they would be more likely to get vaccinated if the vaccines were given full approval.

More importantly, Schaffner said, the FDA’s approval would lay the groundwork for vaccine mandates. “I think those kinds of mandates are going to be necessary to get us up over 80% vaccinated.”

In granting the approval, the agency reviewed a record amount of data from more than 40,000 people who took part in clinical trials. About 12,000 recipients have been followed for at least 6 months, the agency said.

The FDA also reviewed safety data collected since it issued its emergency use authorization for the shots in December.

Based on the results from the clinical trials, the vaccine was 91% effective at preventing COVID-19 disease. But that estimate came from data collected before the Delta variant became widespread.

The most commonly reported side effects in the clinical trials were pain, redness and swelling at the injection site, fatigue, headache, muscle or joint pain, chills, and fever.

The FDA said the vaccine is effective in preventing COVID-19 and potentially serious outcomes, including hospitalization and death.

Based on safety data reviewed since the two-dose vaccine was approved, the FDA said the data demonstrates a higher risk for heart inflammation -- clinically known as myocarditis or pericarditis -- especially within 7 days after the second dose of the shots. The risk is highest for men under age 40, compared to women and older men.

The prescription information includes warnings about these risks. The FDA said the drugmakers must continue to study the risks and long-term effects on people who have myocarditis after vaccination.

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

This article was updated on 8/24/21.

 

The Food and Drug Administration has granted a biological license application, more commonly known as “full approval,” to the Pfizer-BioNTech COVID-19 vaccine.

It is the first COVID-19 vaccine to be fully licensed in the United States. It will be marketed under the trade name Comirnaty. 

The approval applies to individuals ages 16 years and older. The vaccine is still available for emergency use for those ages 12-15.

The FDA’s stamp of approval is somewhat anticlimactic, following months of real-world use and millions of doses doled out to the general population. It comes after months of scrutiny by the agency of the clinical trial data.

Still, the approval puts the vaccines on firmer legal footing and is expected to spur a raft of new vaccination requirements by employers, schools, and universities. 

“The FDA approval is the gold standard,” President Joe Biden said from the White House. “Those who have been waiting for full approval should go and get your shot now.”

“It could save your life or the lives of those you love,” he said.

Biden also called on businesses to mandate COVID vaccines for their employees.

Indeed, soon after the approval was announced, Defense Secretary Lloyd Austin said the vaccines would be required for all 1.4 million active duty service members.


Public health advocates have seen full approval as an important tool to increase U.S. vaccination rates and had criticized the FDA for taking so long to grant the license. 

In a news briefing on the approval, Peter Marks, MD, director of the FDA’s Center for Biologics Evaluation and Research, said the agency had not dragged its feet.

Marks noted that his team had reviewed tens of thousands of pages of clinical trial data -- down to the level of individual patients. They also inspected clinical trial sites and manufacturing facilities, and reviewed information gathered after the vaccines were authorized for use.

“It’s been 97 days since Pfizer completed the role of its [application for approval] and the clock started, which means that we completed this in about 40% of the normal clock time for a submission of this magnitude,” he said. “People worked day and night.”

The agency resisted pressure to speed up its process, saying a thorough review was necessary to ensure public confidence.

“While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated. Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.,” acting FDA Commissioner Janet Woodcock said in a FDA news release.

Experts agreed the move would increase public confidence.

 “I don't expect a big line outside of vaccination sites this afternoon or tomorrow morning, but it will persuade some,” said William Schaffner, MD, a professor of infectious diseases at Vanderbilt University in Nashville.

A recent Kaiser Family Foundation poll found that 3 in 10 unvaccinated adults said they would be more likely to get vaccinated if the vaccines were given full approval.

More importantly, Schaffner said, the FDA’s approval would lay the groundwork for vaccine mandates. “I think those kinds of mandates are going to be necessary to get us up over 80% vaccinated.”

In granting the approval, the agency reviewed a record amount of data from more than 40,000 people who took part in clinical trials. About 12,000 recipients have been followed for at least 6 months, the agency said.

The FDA also reviewed safety data collected since it issued its emergency use authorization for the shots in December.

Based on the results from the clinical trials, the vaccine was 91% effective at preventing COVID-19 disease. But that estimate came from data collected before the Delta variant became widespread.

The most commonly reported side effects in the clinical trials were pain, redness and swelling at the injection site, fatigue, headache, muscle or joint pain, chills, and fever.

The FDA said the vaccine is effective in preventing COVID-19 and potentially serious outcomes, including hospitalization and death.

Based on safety data reviewed since the two-dose vaccine was approved, the FDA said the data demonstrates a higher risk for heart inflammation -- clinically known as myocarditis or pericarditis -- especially within 7 days after the second dose of the shots. The risk is highest for men under age 40, compared to women and older men.

The prescription information includes warnings about these risks. The FDA said the drugmakers must continue to study the risks and long-term effects on people who have myocarditis after vaccination.

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

This article was updated on 8/24/21.

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Shouldn’t docs who spread false COVID-19 info lose their licenses?

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Thu, 08/26/2021 - 15:43

 

A tall, distinguished-looking physician in shirtsleeves and suspenders walked to the microphone at the Mt. Vernon, Ind., school board meeting on a Friday evening in early August. He launched into an impassioned, 7-minute attack on the public health establishment’s medical guidelines for COVID-19.

“The Center for Disease Control and the Indiana State [Department] of Health are giving you very bad scientific guidance,” said Daniel Stock, MD, a primary care physician with a concierge practice in Noblesville, Ind., He described himself as a “functional family medicine physician,” though he is not board certified in family medicine.

Dr. Stock told the school board members that COVID-19 vaccines are counterproductive because they make coronavirus infections worse. He claimed his treatment of “over 15” COVID-19 patients with vitamin D, ivermectin, and zinc has kept them out of the hospital, and that those treatments reduce mortality risk from the disease by 75%. (A study released in mid-August found that ivermectin is ineffective in treating COVID-19).

In response to Dr. Stock’s remarks, the state health department quickly issued a statement reaffirming that COVID-19 vaccines “are highly effective at preventing hospitalizations and deaths.” But by then, the YouTube video of Dr. Stock’s comments had garnered nearly 600,000 views as of Aug. 12 and had been shared over 10,000 times on Facebook. Opponents of COVID-19 vaccines and masking policies across the country have been citing his comments.

Across the country, state medical licensing boards and state and national medical associations are struggling with how to respond to scientifically baseless public statements about COVID-19 by some physicians such as Dr. Stock. They fear such statements are increasing public confusion and are heightening political conflict. Physicians accused of spreading false information include public officials such as Scott Atlas, MD, who served as President Donald Trump’s COVID-19 advisor, and Kentucky Sen. Rand Paul, an ophthalmologist, whose YouTube account was temporarily suspended in August after he posted a video disputing the effectiveness of masking in stopping the spread of COVID-19.

“That’s the problem – those types of viral videos of someone somewhere who thinks they know something the rest of us don’t,” lamented Jennifer Bryan, MD, board chair of the Mississippi State Medical Association. “I don’t know any good reason why a physician should be advising against vaccination. It’s appropriate for medical boards to look into those situations.”

The Federation of State Medical Boards agrees. In July, it warned that physicians who willfully spread false information about COVID-19 risk suspension or revocation of their medical license. The federation cited a “dramatic increase in the dissemination of COVID-19 vaccine misinformation and disinformation by physicians.” That’s particularly dangerous, it said, because physicians enjoy a high degree of public credibility.

Medical boards will particularly examine cases in which there is a pattern of misinformation or disinformation showing that a physician poses a continuing threat to public health, said Hank Chaudhry, DO, the federation’s CEO. In some cases, he said, boards have contacted physicians and have persuaded them to voluntarily refrain from making false public statements, without taking disciplinary action.

“Words matter,” he said. “Physicians have a really big platform, whether they realize it or not. Misinformation or disinformation in the context of COVID can not only cause harm but also death. We felt it was appropriate to remind physicians to be careful.”

Although medical leaders stress that most physicians are promoting solid science on COVID-19, the London-based Center for Countering Digital Hate, in a May report titled “The Disinformation Dozen,” named four U.S. physicians among 12 people who it said produce 65% of the misleading claims and lies about COVID-19 vaccines that abound on Facebook, Instagram, and Twitter. The leading spreader of false claims, the group said, is Joseph Mercola, MD, an Illinois-licensed osteopath living in Cape Coral, Fla. He did not respond to requests for comment.

But so far, state licensing boards and federal and state medical associations generally have been reluctant to discipline or publicly call out physicians who have spread misinformation about the causes, treatments, vaccines, and prevention strategies for COVID-19. Some of these physicians, such as Dr. Mercola, have a long history predating the COVID-19 pandemic of disseminating scientifically baseless information, often in connection with their marketing of products and services.

For instance, the Medical Licensing Board of Indiana and the state attorney general’s office, which brings medical disciplinary actions, declined to comment on Dr. Stock’s public statements at the August school board meeting. When asked about Dr. Stock, the Indiana State Medical Association, without mentioning his name, said: “We urge Hoosier physicians to share the proven facts [about public health measures recommended by the CDC and the Indiana Department of Health] with their patients and their communities.” Dr. Stock did not respond to a request for comment.

Experts say state medical boards are ill equipped and are often unwilling to address the challenge of disciplining physicians who disseminate dangerously false medical information. That enforcement gap is particularly troubling in the middle of a deadly pandemic such as this one.

“Unless you can show a harm to an individual patient, it’s pretty tough to get the boards to do much,” said Art Caplan, PhD, a professor of bioethics at New York University. “I wish they would, but they just don’t.”

That’s partly because state laws require the boards to engage in lengthy, confidential investigations and adversarial legal processes before imposing disciplinary actions. The laws generally require patients or members of the public to file a complaint before an investigation can start. Some states, however, do allow their medical boards to take rapid emergency action if a physician poses an immediate threat to patients or the public.

Another hurdle is that medical boards that seek to sanction physicians for making dangerously misleading public statements could face lawsuits alleging that such actions violate the physicians’ constitutional free speech rights or their professional autonomy.

“We have free speech, and you can get away with a lot of stuff,” said Stephen Barrett, MD, who for many years has critically documented examples of medical fraud on his website, Quackwatch. “Some doctors would sue if they were challenged by medical boards, and I’m not sure the boards would win that court fight. People have written books with advice that killed people, and I’m not aware of a single case where the author was disciplined.”

In addition, it’s not clear that U.S. physicians who are not government officials have any legal obligation – as opposed to a moral obligation – to the government or the public to promote public health, said Jonathan Moreno, PhD, a professor of medical ethics at University of Pennsylvania, Philadelphia. “Is transmitting misinformation about COVID-19 public health malpractice?” he asked. “Do we as a society see physicians having a special role as guides in an emergency? I’d like to think we do, but we don’t have a strong tradition like that in the U.S.”

But California State Sen. Richard Pan, MD, a pediatrician who represents the Sacramento area, doesn’t buy the arguments about why medical boards can’t discipline physicians for spreading misinformation. He successfully sponsored a 2019 bill that strengthens the medical board’s ability to discipline physicians who dole out medically unjustified vaccine exemptions to children.

“A medical license is a privilege. It’s an imprimatur from the state that the person is someone who upholds professional standards,” Dr. Pan said. “If someone is intentionally spreading disinformation for personal gain and that’s putting the public at risk, the medical board has a duty to act.”

There have been only a few publicly announced disciplinary actions related to COVID-19 misinformation so far.

Last December, the Oregon Medical Board, on an emergency basis, suspended the license of Steven LaTulippe, MD, of Dallas, Ore. He had publicly announced that he and his staff were not wearing masks in his clinic. In addition, he compared COVID-19 to the common cold and denied the governor’s legal authority to adopt public health protection measures. A recorded message on his office phone said he’s challenging the licensure action in court.

Last January, the Medical Board of California made Thomas Cowan, MD, of San Francisco surrender his license after Dr. Cowan posted a YouTube video, which went viral last year, that claimed that 5G Internet networks cause COVID-19. He did not respond to a request for comment.

In May, the College of Physicians and Surgeons of British Columbia reprimanded Stephen Malthouse, MD, and forbade him from speaking on issues related to COVID-19. He had written a widely circulated open letter to the province’s chief health office claiming that the pandemic was “over” and that measures to control the spread of COVID-19 were worse than the virus. He has challenged the disciplinary action in court, alleging it violates his right to free speech.

Attacking the problem from a different angle, the U.S. Federal Trade Commission has issued enforcement actions in cases in which physicians and other health care professionals engaged in deceptive business practices related to COVID-19. That approach may be applicable to a number of physicians accused of spreading COVID-19 misinformation, who allegedly have done so at least partly to sell unproven products and services to prevent or treat the disease.

In June, the FTC settled a case against Stephen Meis, MD, of Porterville, Calif. The settlement required that he stop making unsupported claims that his company’s dietary supplements effectively treat COVID-19 symptoms and that he pay $103,420 in refunds to defrauded customers.

State medical boards in the United States generally are not allowed to disclose investigations or disciplinary processes until they finalize a disciplinary action, so other investigations that have not been publicly disclosed may be pending.

A spokesperson for the Medical Board of California said the board is aware of questionable statements about COVID-19 made by several physicians and “will be looking into it.” That comment was in response to a question about statements made at a news conference last year by two Bakersfield emergency physicians, Artin Massihi, MD, and Dan Erickson, DO. They claimed that their COVID-19 testing data showed that the virus is not that dangerous. Dr. Erickson is an osteopath and is regulated by the Osteopathic Medical Board of California.

The two physicians’ news conference prompted an unusual joint statement from the American College of Emergency Medicine and the American Academy of Emergency Medicine in April 2020 declaring that they “emphatically condemn” Dr. Massihi’s and Dr. Erickson’s “reckless and untested musings.” The groups added that it appeared that the physicians issued the comments “to advance their personal financial interests without regard for the public’s health.”

Neither Dr. Massihi nor Dr. Erickson responded to a request for comment.

As for the physician dubbed by the Center for Countering Digital Hate as the world’s most influential spreader of COVID-19 misinformation on social media: No recent public complaints have been filed, and no disciplinary action has been taken against Dr. Mercola, according to a spokesman for the Illinois Department of Financial and Professional Regulation.

According to court records, Dr. Mercola faced disciplinary complaints from the Illinois board in the early 2000s for allegedly providing false and potentially harmful medical advice on his website. There is no record of any final disciplinary action taken against him.

In widely disseminated online posts, Dr. Mercola has called the COVID-19 pandemic a “scam” and said “forced vaccination” is part of a plan to re-set the global economic system. He called COVID-19 vaccines “a medical fraud,” claiming they “alter your genetic coding.” In February, the U.S. Food and Drug Administration ordered Dr. Mercola to stop saying on his website that various vitamins and dietary supplements he sells through his website are effective in preventing or treating COVID-19.

 

 

The New York Times reported in July that Dr. Mercola’s English-language Facebook page has more than 1.7 million followers, that his Spanish-language page has one million, and that he has 300,000 followers on Twitter and 400,000 on YouTube.

In August, Dr. Mercola announced that he was deleting the large archive of articles he’s written on his website but would continue to post articles every day that would be available on the site for only 48 hours. He explained his decision by saying he’s facing “blatant censorship” as part of a “McCarthyism-like attack” from “the sitting President of the United States.” He encouraged people to read his book, “The Truth about COVID-19.”

The lack of action against Dr. Mercola for his lengthy list of scientifically unfounded statements and marketing claims about COVID-19 and other medical conditions infuriates Quackwatch’s Dr. Barrett. He’s amazed that the Illinois board did not discipline Dr. Mercola despite a number of enforcement actions against him by the FTC and the FDA.

“If a doctor were to say to a patient, ‘Don’t wear a mask and don’t get vaccinated,’ the doctor would be held responsible for a bad outcome,” he said. “But if you say it to millions and as a direct result a dozen people die, shouldn’t the doctor also be held responsible for that misinformation? I think he should lose his license.”

Another of the four physicians cited in the “Disinformation Dozen” report is Sherri Tenpenny, DO, an osteopath licensed in Ohio, who has published posts on social media advocating against masking, testing, and vaccines to prevent COVID-19 infections. A spokesperson for the State Medical Board of Ohio said Dr. Tenpenny’s license expires on Oct. 1, 2021, and that any investigation would be confidential. She added that grounds for disciplinary action include “making a false, fraudulent, deceptive, or misleading statement in relation to the practice of medicine and surgery.” Dr. Tenpenny could not be reached for comment.

A third physician named in the report is Christiane Northrup, MD, an ob.gyn. formerly licensed in Maine, who has published posts advocating unproven cures for COVID-19 and claiming that vaccines increase chronic illness. Dennis Smith, executive director of the Maine Board of Licensure in Medicine, said the board received complaints about Dr. Northrup’s posts but can’t act because she withdrew her Maine license in 2015. He added that the Maine board can issue sanctions against physicians who engage in fraud, deceit, or misrepresentation or who post scientifically unfounded statements online.

The fourth physician identified in the “Disinformation Dozen” report is Rashid Buttar, DO, an osteopath practicing in Mooresville, N.C., who has claimed in social media posts that COVID-19 vaccines cause infertility and that COVID-19 tests contain living microorganisms. A spokeswoman for the North Carolina Medical Board said she could not confirm or deny the existence of any investigation of Dr. Buttar, who signed a consent order with the medical board in 2010 following charges of exorbitant fees, worthless tests and treatment, and false diagnoses. Undisclosed conditions were placed on his medical license in 2013. The spokesperson added that the board would investigate any information alleging that a physician spread false information about COVID-19.

Another physician who has caused widespread consternation over scientifically unfounded statements about COVID-19 is Simone Gold, MD, formerly an emergency department physician in Los Angeles. She founded a group called America’s Frontline Doctors, which filed a federal lawsuit in Alabama this spring to block the FDA from issuing an emergency use authorization allowing teenagers to receive COVID-19 vaccinations. She called the vaccines “an experimental biological agent whose harms are well-documented.”

Last summer, Dr. Gold and other physicians in her group held a news conference on the steps of the U.S. Supreme Court Building promoting hydroxychloroquine as a COVID-19 treatment. They declared that masks don’t work and that the virus isn’t deadly, and made other false claims. The news conference was livestreamed by conservative media outlets, was promoted on Twitter by then-President Trump and his family, and was viewed online more than 14 million times.

One of the participating physicians, Stella Immanuel, MD, of Houston, claimed in a video that went viral that she had successfully used hydroxychloroquine for more than 400 patients to cure the disease. In response, the Texas Medical Board, without naming Dr. Immanuel, warned that if it received a complaint about any physician who made a false claim about having a cure for COVID-19, it would investigate and potentially take disciplinary action.

Although no publicly known disciplinary action has been taken against Dr. Gold, she told The Washington Post last January that after participating in that July 2020 news conference, she was fired from her emergency department job at two hospitals and that she hasn’t worked as a physician since. Dr. Gold did not respond to a request for comment.

The outcome in her situation is consistent with the view of NYU’s Dr. Caplan that methods other than medical board discipline – such as action by employers, social media pressure, and reprimands from professional societies –will have to be used to hold physicians accountable for spreading COVID-19 misinformation.

“I’m disappointed to have to say it, but I don’t think medical boards are going to be effective,” he said. “We don’t know how to manage misinformation despite being in a plague. We just don’t.

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

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A tall, distinguished-looking physician in shirtsleeves and suspenders walked to the microphone at the Mt. Vernon, Ind., school board meeting on a Friday evening in early August. He launched into an impassioned, 7-minute attack on the public health establishment’s medical guidelines for COVID-19.

“The Center for Disease Control and the Indiana State [Department] of Health are giving you very bad scientific guidance,” said Daniel Stock, MD, a primary care physician with a concierge practice in Noblesville, Ind., He described himself as a “functional family medicine physician,” though he is not board certified in family medicine.

Dr. Stock told the school board members that COVID-19 vaccines are counterproductive because they make coronavirus infections worse. He claimed his treatment of “over 15” COVID-19 patients with vitamin D, ivermectin, and zinc has kept them out of the hospital, and that those treatments reduce mortality risk from the disease by 75%. (A study released in mid-August found that ivermectin is ineffective in treating COVID-19).

In response to Dr. Stock’s remarks, the state health department quickly issued a statement reaffirming that COVID-19 vaccines “are highly effective at preventing hospitalizations and deaths.” But by then, the YouTube video of Dr. Stock’s comments had garnered nearly 600,000 views as of Aug. 12 and had been shared over 10,000 times on Facebook. Opponents of COVID-19 vaccines and masking policies across the country have been citing his comments.

Across the country, state medical licensing boards and state and national medical associations are struggling with how to respond to scientifically baseless public statements about COVID-19 by some physicians such as Dr. Stock. They fear such statements are increasing public confusion and are heightening political conflict. Physicians accused of spreading false information include public officials such as Scott Atlas, MD, who served as President Donald Trump’s COVID-19 advisor, and Kentucky Sen. Rand Paul, an ophthalmologist, whose YouTube account was temporarily suspended in August after he posted a video disputing the effectiveness of masking in stopping the spread of COVID-19.

“That’s the problem – those types of viral videos of someone somewhere who thinks they know something the rest of us don’t,” lamented Jennifer Bryan, MD, board chair of the Mississippi State Medical Association. “I don’t know any good reason why a physician should be advising against vaccination. It’s appropriate for medical boards to look into those situations.”

The Federation of State Medical Boards agrees. In July, it warned that physicians who willfully spread false information about COVID-19 risk suspension or revocation of their medical license. The federation cited a “dramatic increase in the dissemination of COVID-19 vaccine misinformation and disinformation by physicians.” That’s particularly dangerous, it said, because physicians enjoy a high degree of public credibility.

Medical boards will particularly examine cases in which there is a pattern of misinformation or disinformation showing that a physician poses a continuing threat to public health, said Hank Chaudhry, DO, the federation’s CEO. In some cases, he said, boards have contacted physicians and have persuaded them to voluntarily refrain from making false public statements, without taking disciplinary action.

“Words matter,” he said. “Physicians have a really big platform, whether they realize it or not. Misinformation or disinformation in the context of COVID can not only cause harm but also death. We felt it was appropriate to remind physicians to be careful.”

Although medical leaders stress that most physicians are promoting solid science on COVID-19, the London-based Center for Countering Digital Hate, in a May report titled “The Disinformation Dozen,” named four U.S. physicians among 12 people who it said produce 65% of the misleading claims and lies about COVID-19 vaccines that abound on Facebook, Instagram, and Twitter. The leading spreader of false claims, the group said, is Joseph Mercola, MD, an Illinois-licensed osteopath living in Cape Coral, Fla. He did not respond to requests for comment.

But so far, state licensing boards and federal and state medical associations generally have been reluctant to discipline or publicly call out physicians who have spread misinformation about the causes, treatments, vaccines, and prevention strategies for COVID-19. Some of these physicians, such as Dr. Mercola, have a long history predating the COVID-19 pandemic of disseminating scientifically baseless information, often in connection with their marketing of products and services.

For instance, the Medical Licensing Board of Indiana and the state attorney general’s office, which brings medical disciplinary actions, declined to comment on Dr. Stock’s public statements at the August school board meeting. When asked about Dr. Stock, the Indiana State Medical Association, without mentioning his name, said: “We urge Hoosier physicians to share the proven facts [about public health measures recommended by the CDC and the Indiana Department of Health] with their patients and their communities.” Dr. Stock did not respond to a request for comment.

Experts say state medical boards are ill equipped and are often unwilling to address the challenge of disciplining physicians who disseminate dangerously false medical information. That enforcement gap is particularly troubling in the middle of a deadly pandemic such as this one.

“Unless you can show a harm to an individual patient, it’s pretty tough to get the boards to do much,” said Art Caplan, PhD, a professor of bioethics at New York University. “I wish they would, but they just don’t.”

That’s partly because state laws require the boards to engage in lengthy, confidential investigations and adversarial legal processes before imposing disciplinary actions. The laws generally require patients or members of the public to file a complaint before an investigation can start. Some states, however, do allow their medical boards to take rapid emergency action if a physician poses an immediate threat to patients or the public.

Another hurdle is that medical boards that seek to sanction physicians for making dangerously misleading public statements could face lawsuits alleging that such actions violate the physicians’ constitutional free speech rights or their professional autonomy.

“We have free speech, and you can get away with a lot of stuff,” said Stephen Barrett, MD, who for many years has critically documented examples of medical fraud on his website, Quackwatch. “Some doctors would sue if they were challenged by medical boards, and I’m not sure the boards would win that court fight. People have written books with advice that killed people, and I’m not aware of a single case where the author was disciplined.”

In addition, it’s not clear that U.S. physicians who are not government officials have any legal obligation – as opposed to a moral obligation – to the government or the public to promote public health, said Jonathan Moreno, PhD, a professor of medical ethics at University of Pennsylvania, Philadelphia. “Is transmitting misinformation about COVID-19 public health malpractice?” he asked. “Do we as a society see physicians having a special role as guides in an emergency? I’d like to think we do, but we don’t have a strong tradition like that in the U.S.”

But California State Sen. Richard Pan, MD, a pediatrician who represents the Sacramento area, doesn’t buy the arguments about why medical boards can’t discipline physicians for spreading misinformation. He successfully sponsored a 2019 bill that strengthens the medical board’s ability to discipline physicians who dole out medically unjustified vaccine exemptions to children.

“A medical license is a privilege. It’s an imprimatur from the state that the person is someone who upholds professional standards,” Dr. Pan said. “If someone is intentionally spreading disinformation for personal gain and that’s putting the public at risk, the medical board has a duty to act.”

There have been only a few publicly announced disciplinary actions related to COVID-19 misinformation so far.

Last December, the Oregon Medical Board, on an emergency basis, suspended the license of Steven LaTulippe, MD, of Dallas, Ore. He had publicly announced that he and his staff were not wearing masks in his clinic. In addition, he compared COVID-19 to the common cold and denied the governor’s legal authority to adopt public health protection measures. A recorded message on his office phone said he’s challenging the licensure action in court.

Last January, the Medical Board of California made Thomas Cowan, MD, of San Francisco surrender his license after Dr. Cowan posted a YouTube video, which went viral last year, that claimed that 5G Internet networks cause COVID-19. He did not respond to a request for comment.

In May, the College of Physicians and Surgeons of British Columbia reprimanded Stephen Malthouse, MD, and forbade him from speaking on issues related to COVID-19. He had written a widely circulated open letter to the province’s chief health office claiming that the pandemic was “over” and that measures to control the spread of COVID-19 were worse than the virus. He has challenged the disciplinary action in court, alleging it violates his right to free speech.

Attacking the problem from a different angle, the U.S. Federal Trade Commission has issued enforcement actions in cases in which physicians and other health care professionals engaged in deceptive business practices related to COVID-19. That approach may be applicable to a number of physicians accused of spreading COVID-19 misinformation, who allegedly have done so at least partly to sell unproven products and services to prevent or treat the disease.

In June, the FTC settled a case against Stephen Meis, MD, of Porterville, Calif. The settlement required that he stop making unsupported claims that his company’s dietary supplements effectively treat COVID-19 symptoms and that he pay $103,420 in refunds to defrauded customers.

State medical boards in the United States generally are not allowed to disclose investigations or disciplinary processes until they finalize a disciplinary action, so other investigations that have not been publicly disclosed may be pending.

A spokesperson for the Medical Board of California said the board is aware of questionable statements about COVID-19 made by several physicians and “will be looking into it.” That comment was in response to a question about statements made at a news conference last year by two Bakersfield emergency physicians, Artin Massihi, MD, and Dan Erickson, DO. They claimed that their COVID-19 testing data showed that the virus is not that dangerous. Dr. Erickson is an osteopath and is regulated by the Osteopathic Medical Board of California.

The two physicians’ news conference prompted an unusual joint statement from the American College of Emergency Medicine and the American Academy of Emergency Medicine in April 2020 declaring that they “emphatically condemn” Dr. Massihi’s and Dr. Erickson’s “reckless and untested musings.” The groups added that it appeared that the physicians issued the comments “to advance their personal financial interests without regard for the public’s health.”

Neither Dr. Massihi nor Dr. Erickson responded to a request for comment.

As for the physician dubbed by the Center for Countering Digital Hate as the world’s most influential spreader of COVID-19 misinformation on social media: No recent public complaints have been filed, and no disciplinary action has been taken against Dr. Mercola, according to a spokesman for the Illinois Department of Financial and Professional Regulation.

According to court records, Dr. Mercola faced disciplinary complaints from the Illinois board in the early 2000s for allegedly providing false and potentially harmful medical advice on his website. There is no record of any final disciplinary action taken against him.

In widely disseminated online posts, Dr. Mercola has called the COVID-19 pandemic a “scam” and said “forced vaccination” is part of a plan to re-set the global economic system. He called COVID-19 vaccines “a medical fraud,” claiming they “alter your genetic coding.” In February, the U.S. Food and Drug Administration ordered Dr. Mercola to stop saying on his website that various vitamins and dietary supplements he sells through his website are effective in preventing or treating COVID-19.

 

 

The New York Times reported in July that Dr. Mercola’s English-language Facebook page has more than 1.7 million followers, that his Spanish-language page has one million, and that he has 300,000 followers on Twitter and 400,000 on YouTube.

In August, Dr. Mercola announced that he was deleting the large archive of articles he’s written on his website but would continue to post articles every day that would be available on the site for only 48 hours. He explained his decision by saying he’s facing “blatant censorship” as part of a “McCarthyism-like attack” from “the sitting President of the United States.” He encouraged people to read his book, “The Truth about COVID-19.”

The lack of action against Dr. Mercola for his lengthy list of scientifically unfounded statements and marketing claims about COVID-19 and other medical conditions infuriates Quackwatch’s Dr. Barrett. He’s amazed that the Illinois board did not discipline Dr. Mercola despite a number of enforcement actions against him by the FTC and the FDA.

“If a doctor were to say to a patient, ‘Don’t wear a mask and don’t get vaccinated,’ the doctor would be held responsible for a bad outcome,” he said. “But if you say it to millions and as a direct result a dozen people die, shouldn’t the doctor also be held responsible for that misinformation? I think he should lose his license.”

Another of the four physicians cited in the “Disinformation Dozen” report is Sherri Tenpenny, DO, an osteopath licensed in Ohio, who has published posts on social media advocating against masking, testing, and vaccines to prevent COVID-19 infections. A spokesperson for the State Medical Board of Ohio said Dr. Tenpenny’s license expires on Oct. 1, 2021, and that any investigation would be confidential. She added that grounds for disciplinary action include “making a false, fraudulent, deceptive, or misleading statement in relation to the practice of medicine and surgery.” Dr. Tenpenny could not be reached for comment.

A third physician named in the report is Christiane Northrup, MD, an ob.gyn. formerly licensed in Maine, who has published posts advocating unproven cures for COVID-19 and claiming that vaccines increase chronic illness. Dennis Smith, executive director of the Maine Board of Licensure in Medicine, said the board received complaints about Dr. Northrup’s posts but can’t act because she withdrew her Maine license in 2015. He added that the Maine board can issue sanctions against physicians who engage in fraud, deceit, or misrepresentation or who post scientifically unfounded statements online.

The fourth physician identified in the “Disinformation Dozen” report is Rashid Buttar, DO, an osteopath practicing in Mooresville, N.C., who has claimed in social media posts that COVID-19 vaccines cause infertility and that COVID-19 tests contain living microorganisms. A spokeswoman for the North Carolina Medical Board said she could not confirm or deny the existence of any investigation of Dr. Buttar, who signed a consent order with the medical board in 2010 following charges of exorbitant fees, worthless tests and treatment, and false diagnoses. Undisclosed conditions were placed on his medical license in 2013. The spokesperson added that the board would investigate any information alleging that a physician spread false information about COVID-19.

Another physician who has caused widespread consternation over scientifically unfounded statements about COVID-19 is Simone Gold, MD, formerly an emergency department physician in Los Angeles. She founded a group called America’s Frontline Doctors, which filed a federal lawsuit in Alabama this spring to block the FDA from issuing an emergency use authorization allowing teenagers to receive COVID-19 vaccinations. She called the vaccines “an experimental biological agent whose harms are well-documented.”

Last summer, Dr. Gold and other physicians in her group held a news conference on the steps of the U.S. Supreme Court Building promoting hydroxychloroquine as a COVID-19 treatment. They declared that masks don’t work and that the virus isn’t deadly, and made other false claims. The news conference was livestreamed by conservative media outlets, was promoted on Twitter by then-President Trump and his family, and was viewed online more than 14 million times.

One of the participating physicians, Stella Immanuel, MD, of Houston, claimed in a video that went viral that she had successfully used hydroxychloroquine for more than 400 patients to cure the disease. In response, the Texas Medical Board, without naming Dr. Immanuel, warned that if it received a complaint about any physician who made a false claim about having a cure for COVID-19, it would investigate and potentially take disciplinary action.

Although no publicly known disciplinary action has been taken against Dr. Gold, she told The Washington Post last January that after participating in that July 2020 news conference, she was fired from her emergency department job at two hospitals and that she hasn’t worked as a physician since. Dr. Gold did not respond to a request for comment.

The outcome in her situation is consistent with the view of NYU’s Dr. Caplan that methods other than medical board discipline – such as action by employers, social media pressure, and reprimands from professional societies –will have to be used to hold physicians accountable for spreading COVID-19 misinformation.

“I’m disappointed to have to say it, but I don’t think medical boards are going to be effective,” he said. “We don’t know how to manage misinformation despite being in a plague. We just don’t.

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

 

A tall, distinguished-looking physician in shirtsleeves and suspenders walked to the microphone at the Mt. Vernon, Ind., school board meeting on a Friday evening in early August. He launched into an impassioned, 7-minute attack on the public health establishment’s medical guidelines for COVID-19.

“The Center for Disease Control and the Indiana State [Department] of Health are giving you very bad scientific guidance,” said Daniel Stock, MD, a primary care physician with a concierge practice in Noblesville, Ind., He described himself as a “functional family medicine physician,” though he is not board certified in family medicine.

Dr. Stock told the school board members that COVID-19 vaccines are counterproductive because they make coronavirus infections worse. He claimed his treatment of “over 15” COVID-19 patients with vitamin D, ivermectin, and zinc has kept them out of the hospital, and that those treatments reduce mortality risk from the disease by 75%. (A study released in mid-August found that ivermectin is ineffective in treating COVID-19).

In response to Dr. Stock’s remarks, the state health department quickly issued a statement reaffirming that COVID-19 vaccines “are highly effective at preventing hospitalizations and deaths.” But by then, the YouTube video of Dr. Stock’s comments had garnered nearly 600,000 views as of Aug. 12 and had been shared over 10,000 times on Facebook. Opponents of COVID-19 vaccines and masking policies across the country have been citing his comments.

Across the country, state medical licensing boards and state and national medical associations are struggling with how to respond to scientifically baseless public statements about COVID-19 by some physicians such as Dr. Stock. They fear such statements are increasing public confusion and are heightening political conflict. Physicians accused of spreading false information include public officials such as Scott Atlas, MD, who served as President Donald Trump’s COVID-19 advisor, and Kentucky Sen. Rand Paul, an ophthalmologist, whose YouTube account was temporarily suspended in August after he posted a video disputing the effectiveness of masking in stopping the spread of COVID-19.

“That’s the problem – those types of viral videos of someone somewhere who thinks they know something the rest of us don’t,” lamented Jennifer Bryan, MD, board chair of the Mississippi State Medical Association. “I don’t know any good reason why a physician should be advising against vaccination. It’s appropriate for medical boards to look into those situations.”

The Federation of State Medical Boards agrees. In July, it warned that physicians who willfully spread false information about COVID-19 risk suspension or revocation of their medical license. The federation cited a “dramatic increase in the dissemination of COVID-19 vaccine misinformation and disinformation by physicians.” That’s particularly dangerous, it said, because physicians enjoy a high degree of public credibility.

Medical boards will particularly examine cases in which there is a pattern of misinformation or disinformation showing that a physician poses a continuing threat to public health, said Hank Chaudhry, DO, the federation’s CEO. In some cases, he said, boards have contacted physicians and have persuaded them to voluntarily refrain from making false public statements, without taking disciplinary action.

“Words matter,” he said. “Physicians have a really big platform, whether they realize it or not. Misinformation or disinformation in the context of COVID can not only cause harm but also death. We felt it was appropriate to remind physicians to be careful.”

Although medical leaders stress that most physicians are promoting solid science on COVID-19, the London-based Center for Countering Digital Hate, in a May report titled “The Disinformation Dozen,” named four U.S. physicians among 12 people who it said produce 65% of the misleading claims and lies about COVID-19 vaccines that abound on Facebook, Instagram, and Twitter. The leading spreader of false claims, the group said, is Joseph Mercola, MD, an Illinois-licensed osteopath living in Cape Coral, Fla. He did not respond to requests for comment.

But so far, state licensing boards and federal and state medical associations generally have been reluctant to discipline or publicly call out physicians who have spread misinformation about the causes, treatments, vaccines, and prevention strategies for COVID-19. Some of these physicians, such as Dr. Mercola, have a long history predating the COVID-19 pandemic of disseminating scientifically baseless information, often in connection with their marketing of products and services.

For instance, the Medical Licensing Board of Indiana and the state attorney general’s office, which brings medical disciplinary actions, declined to comment on Dr. Stock’s public statements at the August school board meeting. When asked about Dr. Stock, the Indiana State Medical Association, without mentioning his name, said: “We urge Hoosier physicians to share the proven facts [about public health measures recommended by the CDC and the Indiana Department of Health] with their patients and their communities.” Dr. Stock did not respond to a request for comment.

Experts say state medical boards are ill equipped and are often unwilling to address the challenge of disciplining physicians who disseminate dangerously false medical information. That enforcement gap is particularly troubling in the middle of a deadly pandemic such as this one.

“Unless you can show a harm to an individual patient, it’s pretty tough to get the boards to do much,” said Art Caplan, PhD, a professor of bioethics at New York University. “I wish they would, but they just don’t.”

That’s partly because state laws require the boards to engage in lengthy, confidential investigations and adversarial legal processes before imposing disciplinary actions. The laws generally require patients or members of the public to file a complaint before an investigation can start. Some states, however, do allow their medical boards to take rapid emergency action if a physician poses an immediate threat to patients or the public.

Another hurdle is that medical boards that seek to sanction physicians for making dangerously misleading public statements could face lawsuits alleging that such actions violate the physicians’ constitutional free speech rights or their professional autonomy.

“We have free speech, and you can get away with a lot of stuff,” said Stephen Barrett, MD, who for many years has critically documented examples of medical fraud on his website, Quackwatch. “Some doctors would sue if they were challenged by medical boards, and I’m not sure the boards would win that court fight. People have written books with advice that killed people, and I’m not aware of a single case where the author was disciplined.”

In addition, it’s not clear that U.S. physicians who are not government officials have any legal obligation – as opposed to a moral obligation – to the government or the public to promote public health, said Jonathan Moreno, PhD, a professor of medical ethics at University of Pennsylvania, Philadelphia. “Is transmitting misinformation about COVID-19 public health malpractice?” he asked. “Do we as a society see physicians having a special role as guides in an emergency? I’d like to think we do, but we don’t have a strong tradition like that in the U.S.”

But California State Sen. Richard Pan, MD, a pediatrician who represents the Sacramento area, doesn’t buy the arguments about why medical boards can’t discipline physicians for spreading misinformation. He successfully sponsored a 2019 bill that strengthens the medical board’s ability to discipline physicians who dole out medically unjustified vaccine exemptions to children.

“A medical license is a privilege. It’s an imprimatur from the state that the person is someone who upholds professional standards,” Dr. Pan said. “If someone is intentionally spreading disinformation for personal gain and that’s putting the public at risk, the medical board has a duty to act.”

There have been only a few publicly announced disciplinary actions related to COVID-19 misinformation so far.

Last December, the Oregon Medical Board, on an emergency basis, suspended the license of Steven LaTulippe, MD, of Dallas, Ore. He had publicly announced that he and his staff were not wearing masks in his clinic. In addition, he compared COVID-19 to the common cold and denied the governor’s legal authority to adopt public health protection measures. A recorded message on his office phone said he’s challenging the licensure action in court.

Last January, the Medical Board of California made Thomas Cowan, MD, of San Francisco surrender his license after Dr. Cowan posted a YouTube video, which went viral last year, that claimed that 5G Internet networks cause COVID-19. He did not respond to a request for comment.

In May, the College of Physicians and Surgeons of British Columbia reprimanded Stephen Malthouse, MD, and forbade him from speaking on issues related to COVID-19. He had written a widely circulated open letter to the province’s chief health office claiming that the pandemic was “over” and that measures to control the spread of COVID-19 were worse than the virus. He has challenged the disciplinary action in court, alleging it violates his right to free speech.

Attacking the problem from a different angle, the U.S. Federal Trade Commission has issued enforcement actions in cases in which physicians and other health care professionals engaged in deceptive business practices related to COVID-19. That approach may be applicable to a number of physicians accused of spreading COVID-19 misinformation, who allegedly have done so at least partly to sell unproven products and services to prevent or treat the disease.

In June, the FTC settled a case against Stephen Meis, MD, of Porterville, Calif. The settlement required that he stop making unsupported claims that his company’s dietary supplements effectively treat COVID-19 symptoms and that he pay $103,420 in refunds to defrauded customers.

State medical boards in the United States generally are not allowed to disclose investigations or disciplinary processes until they finalize a disciplinary action, so other investigations that have not been publicly disclosed may be pending.

A spokesperson for the Medical Board of California said the board is aware of questionable statements about COVID-19 made by several physicians and “will be looking into it.” That comment was in response to a question about statements made at a news conference last year by two Bakersfield emergency physicians, Artin Massihi, MD, and Dan Erickson, DO. They claimed that their COVID-19 testing data showed that the virus is not that dangerous. Dr. Erickson is an osteopath and is regulated by the Osteopathic Medical Board of California.

The two physicians’ news conference prompted an unusual joint statement from the American College of Emergency Medicine and the American Academy of Emergency Medicine in April 2020 declaring that they “emphatically condemn” Dr. Massihi’s and Dr. Erickson’s “reckless and untested musings.” The groups added that it appeared that the physicians issued the comments “to advance their personal financial interests without regard for the public’s health.”

Neither Dr. Massihi nor Dr. Erickson responded to a request for comment.

As for the physician dubbed by the Center for Countering Digital Hate as the world’s most influential spreader of COVID-19 misinformation on social media: No recent public complaints have been filed, and no disciplinary action has been taken against Dr. Mercola, according to a spokesman for the Illinois Department of Financial and Professional Regulation.

According to court records, Dr. Mercola faced disciplinary complaints from the Illinois board in the early 2000s for allegedly providing false and potentially harmful medical advice on his website. There is no record of any final disciplinary action taken against him.

In widely disseminated online posts, Dr. Mercola has called the COVID-19 pandemic a “scam” and said “forced vaccination” is part of a plan to re-set the global economic system. He called COVID-19 vaccines “a medical fraud,” claiming they “alter your genetic coding.” In February, the U.S. Food and Drug Administration ordered Dr. Mercola to stop saying on his website that various vitamins and dietary supplements he sells through his website are effective in preventing or treating COVID-19.

 

 

The New York Times reported in July that Dr. Mercola’s English-language Facebook page has more than 1.7 million followers, that his Spanish-language page has one million, and that he has 300,000 followers on Twitter and 400,000 on YouTube.

In August, Dr. Mercola announced that he was deleting the large archive of articles he’s written on his website but would continue to post articles every day that would be available on the site for only 48 hours. He explained his decision by saying he’s facing “blatant censorship” as part of a “McCarthyism-like attack” from “the sitting President of the United States.” He encouraged people to read his book, “The Truth about COVID-19.”

The lack of action against Dr. Mercola for his lengthy list of scientifically unfounded statements and marketing claims about COVID-19 and other medical conditions infuriates Quackwatch’s Dr. Barrett. He’s amazed that the Illinois board did not discipline Dr. Mercola despite a number of enforcement actions against him by the FTC and the FDA.

“If a doctor were to say to a patient, ‘Don’t wear a mask and don’t get vaccinated,’ the doctor would be held responsible for a bad outcome,” he said. “But if you say it to millions and as a direct result a dozen people die, shouldn’t the doctor also be held responsible for that misinformation? I think he should lose his license.”

Another of the four physicians cited in the “Disinformation Dozen” report is Sherri Tenpenny, DO, an osteopath licensed in Ohio, who has published posts on social media advocating against masking, testing, and vaccines to prevent COVID-19 infections. A spokesperson for the State Medical Board of Ohio said Dr. Tenpenny’s license expires on Oct. 1, 2021, and that any investigation would be confidential. She added that grounds for disciplinary action include “making a false, fraudulent, deceptive, or misleading statement in relation to the practice of medicine and surgery.” Dr. Tenpenny could not be reached for comment.

A third physician named in the report is Christiane Northrup, MD, an ob.gyn. formerly licensed in Maine, who has published posts advocating unproven cures for COVID-19 and claiming that vaccines increase chronic illness. Dennis Smith, executive director of the Maine Board of Licensure in Medicine, said the board received complaints about Dr. Northrup’s posts but can’t act because she withdrew her Maine license in 2015. He added that the Maine board can issue sanctions against physicians who engage in fraud, deceit, or misrepresentation or who post scientifically unfounded statements online.

The fourth physician identified in the “Disinformation Dozen” report is Rashid Buttar, DO, an osteopath practicing in Mooresville, N.C., who has claimed in social media posts that COVID-19 vaccines cause infertility and that COVID-19 tests contain living microorganisms. A spokeswoman for the North Carolina Medical Board said she could not confirm or deny the existence of any investigation of Dr. Buttar, who signed a consent order with the medical board in 2010 following charges of exorbitant fees, worthless tests and treatment, and false diagnoses. Undisclosed conditions were placed on his medical license in 2013. The spokesperson added that the board would investigate any information alleging that a physician spread false information about COVID-19.

Another physician who has caused widespread consternation over scientifically unfounded statements about COVID-19 is Simone Gold, MD, formerly an emergency department physician in Los Angeles. She founded a group called America’s Frontline Doctors, which filed a federal lawsuit in Alabama this spring to block the FDA from issuing an emergency use authorization allowing teenagers to receive COVID-19 vaccinations. She called the vaccines “an experimental biological agent whose harms are well-documented.”

Last summer, Dr. Gold and other physicians in her group held a news conference on the steps of the U.S. Supreme Court Building promoting hydroxychloroquine as a COVID-19 treatment. They declared that masks don’t work and that the virus isn’t deadly, and made other false claims. The news conference was livestreamed by conservative media outlets, was promoted on Twitter by then-President Trump and his family, and was viewed online more than 14 million times.

One of the participating physicians, Stella Immanuel, MD, of Houston, claimed in a video that went viral that she had successfully used hydroxychloroquine for more than 400 patients to cure the disease. In response, the Texas Medical Board, without naming Dr. Immanuel, warned that if it received a complaint about any physician who made a false claim about having a cure for COVID-19, it would investigate and potentially take disciplinary action.

Although no publicly known disciplinary action has been taken against Dr. Gold, she told The Washington Post last January that after participating in that July 2020 news conference, she was fired from her emergency department job at two hospitals and that she hasn’t worked as a physician since. Dr. Gold did not respond to a request for comment.

The outcome in her situation is consistent with the view of NYU’s Dr. Caplan that methods other than medical board discipline – such as action by employers, social media pressure, and reprimands from professional societies –will have to be used to hold physicians accountable for spreading COVID-19 misinformation.

“I’m disappointed to have to say it, but I don’t think medical boards are going to be effective,” he said. “We don’t know how to manage misinformation despite being in a plague. We just don’t.

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

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Toward a clearer risk model for postpartum psychosis

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Fri, 08/20/2021 - 14:50

Postpartum depression, in many respects, has become a household term. Over the last decade, there has been increasing awareness of the importance of screening for postpartum depression, with increased systematic screening across clinical settings where care is delivered to women during pregnancy and the postpartum period. There have also been greater efforts to identify women who are suffering postpartum depression and to support them with appropriate clinical interventions, whether through psychotherapy and/or pharmacologic therapy. Clinical interventions are supplemented by the increasing awareness of the value of community-based support groups for women who are suffering from postpartum mood and anxiety disorders.

Dr. Lee S. Cohen

Despite the growing, appropriate focus on recognition and acute treatment of postpartum depression as well as assessing clinical outcomes for those who suffer from postpartum mood and anxiety disorders, less attention has been given to postpartum psychosis, the most severe form of postpartum depression. It is indeed, the least common postpartum psychiatric syndrome (1 in 1,000 births) and comes to public attention when there has been a tragedy during the acute postpartum period such as maternal suicide or infanticide. In this sense, postpartum psychosis is ironically an underappreciated clinical entity across America given its severity, the effect it has on longer-term psychiatric morbidity, and its effect on children and families.

Our group at the Center for Women’s Mental Health has been interested in postpartum psychosis for years and started the Postpartum Psychosis Project in an effort to better understand the phenomenology, course, treatment, outcome, and genomic underpinnings of postpartum psychosis. Risk factors that are well established for postpartum psychosis have been described and overwhelmingly include patients with bipolar disorder. The risk for recurrent postpartum psychosis in women who have had a previous episode is as great as 75%-90% in the absence of prophylactic intervention. With that said, we are extremely interested in understanding the etiology of postpartum psychosis. Various studies over the last 5 years have looked at a whole host of psychosocial as well as neurobiologic variables that may contribute to risk for postpartum psychosis, including dysregulation of the stress axis, heightened inflammation as well as a history of child adversity and heightened experience of stress during the perinatal period.

There have also been anecdotal reports during Virtual Rounds at the Center for Women’s Mental Health of higher recent rates of postpartum psychosis manifesting during the postpartum period. This is a clinical observation and has not been systematically studied. However, one can wonder whether the experience of the pandemic has constituted a stressor for at-risk women, tipping the scales toward women becoming ill, or whether clinicians are seeing this finding more because of our ability to observe it more within the context of the pandemic.

Precise quantification of risk for postpartum psychosis is complicated; as noted, women with bipolar disorder have a predictably high risk for getting ill during the postpartum period and many go on to have clinical courses consistent with recurrent bipolar disorder. However, there are other women who have circumscribed episodes of psychotic illness in the postpartum period who recover and are totally well without any evidence of psychiatric disorder until they have another child, at which time the risk for recurrence of postpartum psychosis is very high. Interest in developing a model of risk that could reliably predict an illness as serious as postpartum psychosis is on the minds of researchers around the world.

One recent study that highlights the multiple factors involved in risk of postpartum psychosis involved a prospective longitudinal study of a group of women who were followed across the peripartum period from the third trimester until 4 weeks postpartum. In this group, 51 women were at increased risk for postpartum psychosis based on their diagnosis of bipolar disorder, schizoaffective disorder, or a previous episode of postpartum psychosis. These women were matched with a control group with no past or current diagnosis of psychiatric disorder or family history of postpartum psychosis. The findings suggested that women at risk for postpartum psychosis who experienced a psychiatric relapse during the first 4 weeks postpartum relative to women at risk who remained well had histories of severe childhood adversity as well as biomarkers consistent with a dysregulated stress axis (a statistically higher daily cortisol level). This is consistent with other data that have implicated the complex role between psychosocial variables as well as neurobiologic variables, such as a dysregulation in the hypothalamic pituitary adrenal axis and other studies that suggest that dysregulated inflammatory status may also drive risk for postpartum psychosis (Hazelgrove K et al. Psychoneuroendocrinology. 2021 Jun. doi: 10.1016/j.psyneuen.2021.105218).

At the end of the day, postpartum psychosis is a psychiatric and obstetrical emergency. In our center, it is rare for women not to be hospitalized with this condition to ensure the safety of the mother as well as her newborn, and to also get her recompensated and functioning as quickly and as significantly as possible. However, an interesting extrapolation of the findings noted by Hazelgrove and colleagues is that it raises the question of what effective treatments might be used to mitigate risk for those at greatest risk for postpartum psychosis. For example, are there other treatments over and above the few effective ones that have been studied as prophylactic pharmacologic interventions that might mitigate risk for recurrence of an illness as serious as postpartum psychosis?

The data suggesting dysregulation of the stress axis as a predictor variable for risk in women vulnerable to postpartum psychosis opens an array of opportunities that are nonpharmacologic, such as mindfulness-based cognitive therapy or other interventions that help to modulate the stress axis. This is a terrific opportunity to have pharmacologic intervention meet nonpharmacologic intervention to potentially mitigate risk for postpartum psychosis with its attendant serious sequelae.

In our own work, where we are evaluating genomic data in an extremely well-characterized group of women with known histories of postpartum psychosis, we are interested to see if we can enhance understanding of the model of risk for postpartum psychosis by factoring in genomic underpinning, history of diagnosis, and psychosocial variables to optimally craft interventions for this population of at-risk women. This brings us one step closer to the future in women’s mental health, to the practice of “precision reproductive psychiatry,” matching interventions to specific presentations across perinatal populations.
 

Dr. Cohen is the director of the Ammon-Pinizzotto Center for Women’s Mental Health at Massachusetts General Hospital in Boston, which provides information resources and conducts clinical care and research in reproductive mental health. He has been a consultant to manufacturers of psychiatric medications. Email Dr. Cohen at [email protected].

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Postpartum depression, in many respects, has become a household term. Over the last decade, there has been increasing awareness of the importance of screening for postpartum depression, with increased systematic screening across clinical settings where care is delivered to women during pregnancy and the postpartum period. There have also been greater efforts to identify women who are suffering postpartum depression and to support them with appropriate clinical interventions, whether through psychotherapy and/or pharmacologic therapy. Clinical interventions are supplemented by the increasing awareness of the value of community-based support groups for women who are suffering from postpartum mood and anxiety disorders.

Dr. Lee S. Cohen

Despite the growing, appropriate focus on recognition and acute treatment of postpartum depression as well as assessing clinical outcomes for those who suffer from postpartum mood and anxiety disorders, less attention has been given to postpartum psychosis, the most severe form of postpartum depression. It is indeed, the least common postpartum psychiatric syndrome (1 in 1,000 births) and comes to public attention when there has been a tragedy during the acute postpartum period such as maternal suicide or infanticide. In this sense, postpartum psychosis is ironically an underappreciated clinical entity across America given its severity, the effect it has on longer-term psychiatric morbidity, and its effect on children and families.

Our group at the Center for Women’s Mental Health has been interested in postpartum psychosis for years and started the Postpartum Psychosis Project in an effort to better understand the phenomenology, course, treatment, outcome, and genomic underpinnings of postpartum psychosis. Risk factors that are well established for postpartum psychosis have been described and overwhelmingly include patients with bipolar disorder. The risk for recurrent postpartum psychosis in women who have had a previous episode is as great as 75%-90% in the absence of prophylactic intervention. With that said, we are extremely interested in understanding the etiology of postpartum psychosis. Various studies over the last 5 years have looked at a whole host of psychosocial as well as neurobiologic variables that may contribute to risk for postpartum psychosis, including dysregulation of the stress axis, heightened inflammation as well as a history of child adversity and heightened experience of stress during the perinatal period.

There have also been anecdotal reports during Virtual Rounds at the Center for Women’s Mental Health of higher recent rates of postpartum psychosis manifesting during the postpartum period. This is a clinical observation and has not been systematically studied. However, one can wonder whether the experience of the pandemic has constituted a stressor for at-risk women, tipping the scales toward women becoming ill, or whether clinicians are seeing this finding more because of our ability to observe it more within the context of the pandemic.

Precise quantification of risk for postpartum psychosis is complicated; as noted, women with bipolar disorder have a predictably high risk for getting ill during the postpartum period and many go on to have clinical courses consistent with recurrent bipolar disorder. However, there are other women who have circumscribed episodes of psychotic illness in the postpartum period who recover and are totally well without any evidence of psychiatric disorder until they have another child, at which time the risk for recurrence of postpartum psychosis is very high. Interest in developing a model of risk that could reliably predict an illness as serious as postpartum psychosis is on the minds of researchers around the world.

One recent study that highlights the multiple factors involved in risk of postpartum psychosis involved a prospective longitudinal study of a group of women who were followed across the peripartum period from the third trimester until 4 weeks postpartum. In this group, 51 women were at increased risk for postpartum psychosis based on their diagnosis of bipolar disorder, schizoaffective disorder, or a previous episode of postpartum psychosis. These women were matched with a control group with no past or current diagnosis of psychiatric disorder or family history of postpartum psychosis. The findings suggested that women at risk for postpartum psychosis who experienced a psychiatric relapse during the first 4 weeks postpartum relative to women at risk who remained well had histories of severe childhood adversity as well as biomarkers consistent with a dysregulated stress axis (a statistically higher daily cortisol level). This is consistent with other data that have implicated the complex role between psychosocial variables as well as neurobiologic variables, such as a dysregulation in the hypothalamic pituitary adrenal axis and other studies that suggest that dysregulated inflammatory status may also drive risk for postpartum psychosis (Hazelgrove K et al. Psychoneuroendocrinology. 2021 Jun. doi: 10.1016/j.psyneuen.2021.105218).

At the end of the day, postpartum psychosis is a psychiatric and obstetrical emergency. In our center, it is rare for women not to be hospitalized with this condition to ensure the safety of the mother as well as her newborn, and to also get her recompensated and functioning as quickly and as significantly as possible. However, an interesting extrapolation of the findings noted by Hazelgrove and colleagues is that it raises the question of what effective treatments might be used to mitigate risk for those at greatest risk for postpartum psychosis. For example, are there other treatments over and above the few effective ones that have been studied as prophylactic pharmacologic interventions that might mitigate risk for recurrence of an illness as serious as postpartum psychosis?

The data suggesting dysregulation of the stress axis as a predictor variable for risk in women vulnerable to postpartum psychosis opens an array of opportunities that are nonpharmacologic, such as mindfulness-based cognitive therapy or other interventions that help to modulate the stress axis. This is a terrific opportunity to have pharmacologic intervention meet nonpharmacologic intervention to potentially mitigate risk for postpartum psychosis with its attendant serious sequelae.

In our own work, where we are evaluating genomic data in an extremely well-characterized group of women with known histories of postpartum psychosis, we are interested to see if we can enhance understanding of the model of risk for postpartum psychosis by factoring in genomic underpinning, history of diagnosis, and psychosocial variables to optimally craft interventions for this population of at-risk women. This brings us one step closer to the future in women’s mental health, to the practice of “precision reproductive psychiatry,” matching interventions to specific presentations across perinatal populations.
 

Dr. Cohen is the director of the Ammon-Pinizzotto Center for Women’s Mental Health at Massachusetts General Hospital in Boston, which provides information resources and conducts clinical care and research in reproductive mental health. He has been a consultant to manufacturers of psychiatric medications. Email Dr. Cohen at [email protected].

Postpartum depression, in many respects, has become a household term. Over the last decade, there has been increasing awareness of the importance of screening for postpartum depression, with increased systematic screening across clinical settings where care is delivered to women during pregnancy and the postpartum period. There have also been greater efforts to identify women who are suffering postpartum depression and to support them with appropriate clinical interventions, whether through psychotherapy and/or pharmacologic therapy. Clinical interventions are supplemented by the increasing awareness of the value of community-based support groups for women who are suffering from postpartum mood and anxiety disorders.

Dr. Lee S. Cohen

Despite the growing, appropriate focus on recognition and acute treatment of postpartum depression as well as assessing clinical outcomes for those who suffer from postpartum mood and anxiety disorders, less attention has been given to postpartum psychosis, the most severe form of postpartum depression. It is indeed, the least common postpartum psychiatric syndrome (1 in 1,000 births) and comes to public attention when there has been a tragedy during the acute postpartum period such as maternal suicide or infanticide. In this sense, postpartum psychosis is ironically an underappreciated clinical entity across America given its severity, the effect it has on longer-term psychiatric morbidity, and its effect on children and families.

Our group at the Center for Women’s Mental Health has been interested in postpartum psychosis for years and started the Postpartum Psychosis Project in an effort to better understand the phenomenology, course, treatment, outcome, and genomic underpinnings of postpartum psychosis. Risk factors that are well established for postpartum psychosis have been described and overwhelmingly include patients with bipolar disorder. The risk for recurrent postpartum psychosis in women who have had a previous episode is as great as 75%-90% in the absence of prophylactic intervention. With that said, we are extremely interested in understanding the etiology of postpartum psychosis. Various studies over the last 5 years have looked at a whole host of psychosocial as well as neurobiologic variables that may contribute to risk for postpartum psychosis, including dysregulation of the stress axis, heightened inflammation as well as a history of child adversity and heightened experience of stress during the perinatal period.

There have also been anecdotal reports during Virtual Rounds at the Center for Women’s Mental Health of higher recent rates of postpartum psychosis manifesting during the postpartum period. This is a clinical observation and has not been systematically studied. However, one can wonder whether the experience of the pandemic has constituted a stressor for at-risk women, tipping the scales toward women becoming ill, or whether clinicians are seeing this finding more because of our ability to observe it more within the context of the pandemic.

Precise quantification of risk for postpartum psychosis is complicated; as noted, women with bipolar disorder have a predictably high risk for getting ill during the postpartum period and many go on to have clinical courses consistent with recurrent bipolar disorder. However, there are other women who have circumscribed episodes of psychotic illness in the postpartum period who recover and are totally well without any evidence of psychiatric disorder until they have another child, at which time the risk for recurrence of postpartum psychosis is very high. Interest in developing a model of risk that could reliably predict an illness as serious as postpartum psychosis is on the minds of researchers around the world.

One recent study that highlights the multiple factors involved in risk of postpartum psychosis involved a prospective longitudinal study of a group of women who were followed across the peripartum period from the third trimester until 4 weeks postpartum. In this group, 51 women were at increased risk for postpartum psychosis based on their diagnosis of bipolar disorder, schizoaffective disorder, or a previous episode of postpartum psychosis. These women were matched with a control group with no past or current diagnosis of psychiatric disorder or family history of postpartum psychosis. The findings suggested that women at risk for postpartum psychosis who experienced a psychiatric relapse during the first 4 weeks postpartum relative to women at risk who remained well had histories of severe childhood adversity as well as biomarkers consistent with a dysregulated stress axis (a statistically higher daily cortisol level). This is consistent with other data that have implicated the complex role between psychosocial variables as well as neurobiologic variables, such as a dysregulation in the hypothalamic pituitary adrenal axis and other studies that suggest that dysregulated inflammatory status may also drive risk for postpartum psychosis (Hazelgrove K et al. Psychoneuroendocrinology. 2021 Jun. doi: 10.1016/j.psyneuen.2021.105218).

At the end of the day, postpartum psychosis is a psychiatric and obstetrical emergency. In our center, it is rare for women not to be hospitalized with this condition to ensure the safety of the mother as well as her newborn, and to also get her recompensated and functioning as quickly and as significantly as possible. However, an interesting extrapolation of the findings noted by Hazelgrove and colleagues is that it raises the question of what effective treatments might be used to mitigate risk for those at greatest risk for postpartum psychosis. For example, are there other treatments over and above the few effective ones that have been studied as prophylactic pharmacologic interventions that might mitigate risk for recurrence of an illness as serious as postpartum psychosis?

The data suggesting dysregulation of the stress axis as a predictor variable for risk in women vulnerable to postpartum psychosis opens an array of opportunities that are nonpharmacologic, such as mindfulness-based cognitive therapy or other interventions that help to modulate the stress axis. This is a terrific opportunity to have pharmacologic intervention meet nonpharmacologic intervention to potentially mitigate risk for postpartum psychosis with its attendant serious sequelae.

In our own work, where we are evaluating genomic data in an extremely well-characterized group of women with known histories of postpartum psychosis, we are interested to see if we can enhance understanding of the model of risk for postpartum psychosis by factoring in genomic underpinning, history of diagnosis, and psychosocial variables to optimally craft interventions for this population of at-risk women. This brings us one step closer to the future in women’s mental health, to the practice of “precision reproductive psychiatry,” matching interventions to specific presentations across perinatal populations.
 

Dr. Cohen is the director of the Ammon-Pinizzotto Center for Women’s Mental Health at Massachusetts General Hospital in Boston, which provides information resources and conducts clinical care and research in reproductive mental health. He has been a consultant to manufacturers of psychiatric medications. Email Dr. Cohen at [email protected].

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Delta whiplash: How the new surge is affecting mental health

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Thu, 08/26/2021 - 15:43

Thanks to the rollout of the COVID-19 vaccines, more than just flowers were blooming this past spring. People came out of lockdown like bears emerging from hibernation, making plans to reunite with friends and loved ones they hadn’t seen in months. But with the tremendous surge in cases brought by the Delta variant, this summer has been anything but sunny and carefree. Case counts have once more reached prevaccination levels. In a repeat of last summer, people are canceling travel plans, and the lead-up to the new school year has become fraught and stressful.

“This whiplash is causing people to feel a variety of emotions: disappointment, uncertainty, anxiety, possibly anger and frustration,” says Vaile Wright, Ph.D., senior director of health care innovation at the American Psychological Association. “When it seemed like there was a light at the end of the tunnel, and we have the tools to overcome [the virus], and we’re not really using them, it can be hard for people to understand.”
 

The importance of hope

For decades, researchers have been digging into the crucial role hopefulness plays in mental health. The vaccine rollout, earlier than anticipated, provided a much needed burst of hope after months of bad news.

“It was a feeling of almost euphoria in June: ‘We’re going to see everybody!’” says Rachel Goldenberg, a rabbi in Jackson Heights, NY. “We have a theme for our High Holidays, and this year’s is very hopeful: Sow in tears, reap in joy. It felt like the sowing in tears part was behind us, and we were looking forward to reaping in joy. Slowly but surely, with Delta, everything has turned upside down.”

For Roxanne Hawn, a writer in Golden, Colo., vaccination offered a glimpse of something like normal life.

“I wore cute clothes. I stopped and got takeout for lunch. I bought myself flowers. I even had a little uplifting soundtrack for that time of hope and relief,” she says. “With the Delta variant, it feels like that window of normalcy closed quickly.”

Having that little bit of hope dashed can wear down even the sturdiest spirits, says Marissa King, PhD, author of “Social Chemistry: Decoding the Elements of Human Connection”.

“There was a moment when we were able to reconnect, to experience joy and the hope of being able to revitalize relationships,” she says. “The loss of that hope and the fear of being isolated again is causing so much distress.”
 

A new kind of loneliness

When the pandemic started, mom of three Julie Schwietert Collazo formed a WhatsApp group with several friends who were taking lockdown seriously. They got each other through months of isolation and celebrated the idea of reopening. Then Ms. Collazo’s oldest got COVID, just 5 weeks before her 12th birthday, and their family went back into quarantine. Her moms’ group is no longer on the same page about precautions.

“Last year we were doing it together, and it made it feel a bit easier,” she says. “As things started to normalize, everybody started thinking and moving in different directions. It feels like we’re not working through the same issues collectively like before.”

Dr. King says the feeling Ms. Collazo describes is quite common these days.

“A profound sense of loneliness comes from feeling like you’re the only one,” she says. “There’s such disagreement about the best path forward, it can feel lonely just because you think differently.”
 

 

 

An epidemic of anxiety

As the Delta variant drives case numbers back up again, worries increase as well.

“Is this ever going to end?” asks Ms. Collazo. “Is this our new reality, constantly having to order our lives around COVID?”

This uneasiness affects our well-being.

The National Center for Health Statistics and the Census Bureau have monitored the nation’s mental health via the ongoing Household Pulse Survey during the pandemic. It asks participants about their symptoms of either anxiety or depression. Throughout, more people have reported feeling anxious than depressed.

Anxiety peaked around Thanksgiving and Christmas, with nearly 38% of people reporting symptoms. The first vaccines began to roll out around that time, and anxiety levels steadily went down through the spring and early summer, dipping below 25% in late June. But those numbers have begun to creep back up – the most recent data, which goes through Aug. 2, found 27% of Americans reporting symptoms of anxiety.

“Nervous is the new normal,” says Vivian Pender, MD, president of the American Psychiatric Association. “Uncertainty makes people feel anxious.”
 

Empathy vs. anger

The way politics play into basic measures like mask-wearing and vaccination adds its own layer of stress. Physical altercations have resulted: In Los Angeles, a participant was stabbed at an antivaccination protest. At an Austin, Tex., elementary school, angry parents physically and verbally assaulted teachers who wore masks. Things have gotten so heated, the Department of Homeland Security issued a National Terrorism Advisory System bulletin last week. It warns that extremists could use new COVID-driven public health restrictions as an excuse to commit domestic terrorism.

Anger goes in the opposite direction, too, with people who’ve been following recommended procedures becoming increasingly fed up with those who flout them. Those intense emotions may not lead to violence, but they do make it harder for us to feel secure.

“It’s a public health crisis, and it’s turned into something different. When we get into us/them situations, we start to lose empathy. Empathy is important to identify solutions and work together as a community,” says Dr. Wright. “That’s what sparks the anger: the sense of ‘You aren’t doing what you’re supposed to be doing.’”
 

How to cope

Loneliness, anxiety, and anger may be swirling all around you right now. But that doesn’t make you powerless to boost your mental health. These suggestions may help:

  • Trust your gut. If your community is reopening faster than feels comfortable to you, do whatever makes your family feel safe. “Ask yourself how you’re feeling, and use your feelings to guide your decisions,” says Dr. Pender. “Get more information, then follow the science.”
  • Stop judging yourself. If you’re feeling lonely or mourning the losses COVID has brought, don’t fight it, says Wright. “Let it be an emotion that comes and goes, and try to find ways to feel connected to other people.”
  • Practice self-care. It may sound simplistic, but eating healthy foods, exercising, and getting a good night’s sleep can all contribute to a more positive 
  • Try to ease anxiety. Meditation, calming self-talk, and soothing music can all lift your spirits. Or try diaphragmatic breathing: Breathe in for 5 seconds, hold for 2, and breathe out for 5. Even squeezing a stress ball can give you a tangible sense of 
  • Take action. Both Rabbi Goldenberg and Ms. Collazo, who runs a nonprofit that works to reunite immigrant families, say helping their community helps them feel better. “To sing and lead Shabbat services, even on Zoom, to see the faces of my people, it’s very healing,” says Rabbi Goldenberg. One small thing you can do: If you have family or friends who are hesitant about vaccination, Dr. Wright suggests having gentle conversations to convince them. “You can be way more influential than a celebrity,” she says.
  • Remember you’re not alone. Whether you’re physically isolated from others or just feel like nobody else is following the same protocols as you, there are ways to feel connected. “Reach out to people you’ve been close with in the past, but you may have lost touch,” says Dr. King. “It gives you an opportunity to rekindle joy. Particularly in this moment, when a lot of people are so afraid, it’s easier to reach out to those you already know than try to meet new people.” Dr. King’s research has found it takes as few as two close connections to make people feel supported.
  • Stay in the present. Instead of stressing over what’s already happened or worrying about what might still come, just think about today. “We’ve learned a lot about the coronavirus, and we’re still learning more,” says Dr. Wright. “We don’t know what the future looks like, but it won’t be like this forever.”

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

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Thanks to the rollout of the COVID-19 vaccines, more than just flowers were blooming this past spring. People came out of lockdown like bears emerging from hibernation, making plans to reunite with friends and loved ones they hadn’t seen in months. But with the tremendous surge in cases brought by the Delta variant, this summer has been anything but sunny and carefree. Case counts have once more reached prevaccination levels. In a repeat of last summer, people are canceling travel plans, and the lead-up to the new school year has become fraught and stressful.

“This whiplash is causing people to feel a variety of emotions: disappointment, uncertainty, anxiety, possibly anger and frustration,” says Vaile Wright, Ph.D., senior director of health care innovation at the American Psychological Association. “When it seemed like there was a light at the end of the tunnel, and we have the tools to overcome [the virus], and we’re not really using them, it can be hard for people to understand.”
 

The importance of hope

For decades, researchers have been digging into the crucial role hopefulness plays in mental health. The vaccine rollout, earlier than anticipated, provided a much needed burst of hope after months of bad news.

“It was a feeling of almost euphoria in June: ‘We’re going to see everybody!’” says Rachel Goldenberg, a rabbi in Jackson Heights, NY. “We have a theme for our High Holidays, and this year’s is very hopeful: Sow in tears, reap in joy. It felt like the sowing in tears part was behind us, and we were looking forward to reaping in joy. Slowly but surely, with Delta, everything has turned upside down.”

For Roxanne Hawn, a writer in Golden, Colo., vaccination offered a glimpse of something like normal life.

“I wore cute clothes. I stopped and got takeout for lunch. I bought myself flowers. I even had a little uplifting soundtrack for that time of hope and relief,” she says. “With the Delta variant, it feels like that window of normalcy closed quickly.”

Having that little bit of hope dashed can wear down even the sturdiest spirits, says Marissa King, PhD, author of “Social Chemistry: Decoding the Elements of Human Connection”.

“There was a moment when we were able to reconnect, to experience joy and the hope of being able to revitalize relationships,” she says. “The loss of that hope and the fear of being isolated again is causing so much distress.”
 

A new kind of loneliness

When the pandemic started, mom of three Julie Schwietert Collazo formed a WhatsApp group with several friends who were taking lockdown seriously. They got each other through months of isolation and celebrated the idea of reopening. Then Ms. Collazo’s oldest got COVID, just 5 weeks before her 12th birthday, and their family went back into quarantine. Her moms’ group is no longer on the same page about precautions.

“Last year we were doing it together, and it made it feel a bit easier,” she says. “As things started to normalize, everybody started thinking and moving in different directions. It feels like we’re not working through the same issues collectively like before.”

Dr. King says the feeling Ms. Collazo describes is quite common these days.

“A profound sense of loneliness comes from feeling like you’re the only one,” she says. “There’s such disagreement about the best path forward, it can feel lonely just because you think differently.”
 

 

 

An epidemic of anxiety

As the Delta variant drives case numbers back up again, worries increase as well.

“Is this ever going to end?” asks Ms. Collazo. “Is this our new reality, constantly having to order our lives around COVID?”

This uneasiness affects our well-being.

The National Center for Health Statistics and the Census Bureau have monitored the nation’s mental health via the ongoing Household Pulse Survey during the pandemic. It asks participants about their symptoms of either anxiety or depression. Throughout, more people have reported feeling anxious than depressed.

Anxiety peaked around Thanksgiving and Christmas, with nearly 38% of people reporting symptoms. The first vaccines began to roll out around that time, and anxiety levels steadily went down through the spring and early summer, dipping below 25% in late June. But those numbers have begun to creep back up – the most recent data, which goes through Aug. 2, found 27% of Americans reporting symptoms of anxiety.

“Nervous is the new normal,” says Vivian Pender, MD, president of the American Psychiatric Association. “Uncertainty makes people feel anxious.”
 

Empathy vs. anger

The way politics play into basic measures like mask-wearing and vaccination adds its own layer of stress. Physical altercations have resulted: In Los Angeles, a participant was stabbed at an antivaccination protest. At an Austin, Tex., elementary school, angry parents physically and verbally assaulted teachers who wore masks. Things have gotten so heated, the Department of Homeland Security issued a National Terrorism Advisory System bulletin last week. It warns that extremists could use new COVID-driven public health restrictions as an excuse to commit domestic terrorism.

Anger goes in the opposite direction, too, with people who’ve been following recommended procedures becoming increasingly fed up with those who flout them. Those intense emotions may not lead to violence, but they do make it harder for us to feel secure.

“It’s a public health crisis, and it’s turned into something different. When we get into us/them situations, we start to lose empathy. Empathy is important to identify solutions and work together as a community,” says Dr. Wright. “That’s what sparks the anger: the sense of ‘You aren’t doing what you’re supposed to be doing.’”
 

How to cope

Loneliness, anxiety, and anger may be swirling all around you right now. But that doesn’t make you powerless to boost your mental health. These suggestions may help:

  • Trust your gut. If your community is reopening faster than feels comfortable to you, do whatever makes your family feel safe. “Ask yourself how you’re feeling, and use your feelings to guide your decisions,” says Dr. Pender. “Get more information, then follow the science.”
  • Stop judging yourself. If you’re feeling lonely or mourning the losses COVID has brought, don’t fight it, says Wright. “Let it be an emotion that comes and goes, and try to find ways to feel connected to other people.”
  • Practice self-care. It may sound simplistic, but eating healthy foods, exercising, and getting a good night’s sleep can all contribute to a more positive 
  • Try to ease anxiety. Meditation, calming self-talk, and soothing music can all lift your spirits. Or try diaphragmatic breathing: Breathe in for 5 seconds, hold for 2, and breathe out for 5. Even squeezing a stress ball can give you a tangible sense of 
  • Take action. Both Rabbi Goldenberg and Ms. Collazo, who runs a nonprofit that works to reunite immigrant families, say helping their community helps them feel better. “To sing and lead Shabbat services, even on Zoom, to see the faces of my people, it’s very healing,” says Rabbi Goldenberg. One small thing you can do: If you have family or friends who are hesitant about vaccination, Dr. Wright suggests having gentle conversations to convince them. “You can be way more influential than a celebrity,” she says.
  • Remember you’re not alone. Whether you’re physically isolated from others or just feel like nobody else is following the same protocols as you, there are ways to feel connected. “Reach out to people you’ve been close with in the past, but you may have lost touch,” says Dr. King. “It gives you an opportunity to rekindle joy. Particularly in this moment, when a lot of people are so afraid, it’s easier to reach out to those you already know than try to meet new people.” Dr. King’s research has found it takes as few as two close connections to make people feel supported.
  • Stay in the present. Instead of stressing over what’s already happened or worrying about what might still come, just think about today. “We’ve learned a lot about the coronavirus, and we’re still learning more,” says Dr. Wright. “We don’t know what the future looks like, but it won’t be like this forever.”

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

Thanks to the rollout of the COVID-19 vaccines, more than just flowers were blooming this past spring. People came out of lockdown like bears emerging from hibernation, making plans to reunite with friends and loved ones they hadn’t seen in months. But with the tremendous surge in cases brought by the Delta variant, this summer has been anything but sunny and carefree. Case counts have once more reached prevaccination levels. In a repeat of last summer, people are canceling travel plans, and the lead-up to the new school year has become fraught and stressful.

“This whiplash is causing people to feel a variety of emotions: disappointment, uncertainty, anxiety, possibly anger and frustration,” says Vaile Wright, Ph.D., senior director of health care innovation at the American Psychological Association. “When it seemed like there was a light at the end of the tunnel, and we have the tools to overcome [the virus], and we’re not really using them, it can be hard for people to understand.”
 

The importance of hope

For decades, researchers have been digging into the crucial role hopefulness plays in mental health. The vaccine rollout, earlier than anticipated, provided a much needed burst of hope after months of bad news.

“It was a feeling of almost euphoria in June: ‘We’re going to see everybody!’” says Rachel Goldenberg, a rabbi in Jackson Heights, NY. “We have a theme for our High Holidays, and this year’s is very hopeful: Sow in tears, reap in joy. It felt like the sowing in tears part was behind us, and we were looking forward to reaping in joy. Slowly but surely, with Delta, everything has turned upside down.”

For Roxanne Hawn, a writer in Golden, Colo., vaccination offered a glimpse of something like normal life.

“I wore cute clothes. I stopped and got takeout for lunch. I bought myself flowers. I even had a little uplifting soundtrack for that time of hope and relief,” she says. “With the Delta variant, it feels like that window of normalcy closed quickly.”

Having that little bit of hope dashed can wear down even the sturdiest spirits, says Marissa King, PhD, author of “Social Chemistry: Decoding the Elements of Human Connection”.

“There was a moment when we were able to reconnect, to experience joy and the hope of being able to revitalize relationships,” she says. “The loss of that hope and the fear of being isolated again is causing so much distress.”
 

A new kind of loneliness

When the pandemic started, mom of three Julie Schwietert Collazo formed a WhatsApp group with several friends who were taking lockdown seriously. They got each other through months of isolation and celebrated the idea of reopening. Then Ms. Collazo’s oldest got COVID, just 5 weeks before her 12th birthday, and their family went back into quarantine. Her moms’ group is no longer on the same page about precautions.

“Last year we were doing it together, and it made it feel a bit easier,” she says. “As things started to normalize, everybody started thinking and moving in different directions. It feels like we’re not working through the same issues collectively like before.”

Dr. King says the feeling Ms. Collazo describes is quite common these days.

“A profound sense of loneliness comes from feeling like you’re the only one,” she says. “There’s such disagreement about the best path forward, it can feel lonely just because you think differently.”
 

 

 

An epidemic of anxiety

As the Delta variant drives case numbers back up again, worries increase as well.

“Is this ever going to end?” asks Ms. Collazo. “Is this our new reality, constantly having to order our lives around COVID?”

This uneasiness affects our well-being.

The National Center for Health Statistics and the Census Bureau have monitored the nation’s mental health via the ongoing Household Pulse Survey during the pandemic. It asks participants about their symptoms of either anxiety or depression. Throughout, more people have reported feeling anxious than depressed.

Anxiety peaked around Thanksgiving and Christmas, with nearly 38% of people reporting symptoms. The first vaccines began to roll out around that time, and anxiety levels steadily went down through the spring and early summer, dipping below 25% in late June. But those numbers have begun to creep back up – the most recent data, which goes through Aug. 2, found 27% of Americans reporting symptoms of anxiety.

“Nervous is the new normal,” says Vivian Pender, MD, president of the American Psychiatric Association. “Uncertainty makes people feel anxious.”
 

Empathy vs. anger

The way politics play into basic measures like mask-wearing and vaccination adds its own layer of stress. Physical altercations have resulted: In Los Angeles, a participant was stabbed at an antivaccination protest. At an Austin, Tex., elementary school, angry parents physically and verbally assaulted teachers who wore masks. Things have gotten so heated, the Department of Homeland Security issued a National Terrorism Advisory System bulletin last week. It warns that extremists could use new COVID-driven public health restrictions as an excuse to commit domestic terrorism.

Anger goes in the opposite direction, too, with people who’ve been following recommended procedures becoming increasingly fed up with those who flout them. Those intense emotions may not lead to violence, but they do make it harder for us to feel secure.

“It’s a public health crisis, and it’s turned into something different. When we get into us/them situations, we start to lose empathy. Empathy is important to identify solutions and work together as a community,” says Dr. Wright. “That’s what sparks the anger: the sense of ‘You aren’t doing what you’re supposed to be doing.’”
 

How to cope

Loneliness, anxiety, and anger may be swirling all around you right now. But that doesn’t make you powerless to boost your mental health. These suggestions may help:

  • Trust your gut. If your community is reopening faster than feels comfortable to you, do whatever makes your family feel safe. “Ask yourself how you’re feeling, and use your feelings to guide your decisions,” says Dr. Pender. “Get more information, then follow the science.”
  • Stop judging yourself. If you’re feeling lonely or mourning the losses COVID has brought, don’t fight it, says Wright. “Let it be an emotion that comes and goes, and try to find ways to feel connected to other people.”
  • Practice self-care. It may sound simplistic, but eating healthy foods, exercising, and getting a good night’s sleep can all contribute to a more positive 
  • Try to ease anxiety. Meditation, calming self-talk, and soothing music can all lift your spirits. Or try diaphragmatic breathing: Breathe in for 5 seconds, hold for 2, and breathe out for 5. Even squeezing a stress ball can give you a tangible sense of 
  • Take action. Both Rabbi Goldenberg and Ms. Collazo, who runs a nonprofit that works to reunite immigrant families, say helping their community helps them feel better. “To sing and lead Shabbat services, even on Zoom, to see the faces of my people, it’s very healing,” says Rabbi Goldenberg. One small thing you can do: If you have family or friends who are hesitant about vaccination, Dr. Wright suggests having gentle conversations to convince them. “You can be way more influential than a celebrity,” she says.
  • Remember you’re not alone. Whether you’re physically isolated from others or just feel like nobody else is following the same protocols as you, there are ways to feel connected. “Reach out to people you’ve been close with in the past, but you may have lost touch,” says Dr. King. “It gives you an opportunity to rekindle joy. Particularly in this moment, when a lot of people are so afraid, it’s easier to reach out to those you already know than try to meet new people.” Dr. King’s research has found it takes as few as two close connections to make people feel supported.
  • Stay in the present. Instead of stressing over what’s already happened or worrying about what might still come, just think about today. “We’ve learned a lot about the coronavirus, and we’re still learning more,” says Dr. Wright. “We don’t know what the future looks like, but it won’t be like this forever.”

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

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How to pick the best face masks for children, according to the experts

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Thu, 08/26/2021 - 15:43

 

One essential back-to-school item for children this fall is a face mask – the Centers for Disease Control and Prevention and the American Academy of Pediatrics both recommend them – but finding one that’s actually protective for a child is not a straightforward task, as many parents can attest. 

There’s little in the way of official guidance or research to inform evidence-based recommendations on what type of face masks works best for children. 

Search for children’s face masks on Amazon and you’ll run into a smorgasbord of options: masks with three, four, or five layers, different designs, and different materials. There’s one company selling a mask it calls an m95 model, a term the company devised. 

It’s almost impossible to verify many of the claims being made by the manufacturers, or to know if they will fit your child’s face until you order some, which can get expensive.

But it’s worth looking for a good mask.  A large study of more than 1 million people being conducted online by Facebook and Carnegie Mellon University found that students who wore face masks in school had a reduced risk for testing positive for the virus and getting sick with COVID-19 symptoms. The study was published in June in the journal Science.
 

Delta more contagious

The Delta variant of the new coronavirus is much more contagious than previous versions of the virus. Studies have shown that infected people carry 1,000 times more virus in their noses and throats than with the viruses that circulated last winter and spring. They shed more viral particles into the air when they talk or yell or sing, making this COVID-19–causing virus much more transmissible than in the past.

What that means, says Kimberly Prather, PhD, an aerosol scientist and distinguished professor at the Scripps Institution of Oceanography in La Jolla, California, is that if it once took about 15 minutes of proximity to an infected person to catch the infection, that window of risk is now much shorter.

“If you believe the 15-minute magical number, now if you take 1,000 times the viral load, basically in 1 second you could inhale that same amount of virus. So it’s gone from 15 minutes to 1 second,” Dr. Prather said in an online seminar on school safety she helped to organize. 
 

A better mask

What that means is that we need to upgrade our face masks, switching away from ill-fitting fabric masks, which can offer varying degrees of protection depending on the number of layers and type of fabric that’s used, to more highly protective surgical masks or better yet, N95 respirators, which provide the highest level of filtration.

That’s harder to do for children, who have much smaller faces.

Any masks that gapes around the edges isn’t going to work well, no matter how well it filters.

“N95s are not made to fit kids. They do not come in kid sizes, so I do not recommend N95s for kids,” said Linsey Marr, an environmental engineer at Virginia Tech, who tests face masks in her lab.

Ms. Marr says parents need to consider the attributes masks in this order of priority: 

Comfort: “If your kid won’t wear it, it’s not helping at all,” she said.

Fit: “Leaks around the sides are like having a hole in your mask and aerosols carrying the virus can get right through,” Ms. Marr said.

Filtration: How well the mask blocks small particles.

One option to improve fit is to layer a fabric mask over a surgical mask. The fabric mask helps to hold the edges of the surgical mask more tightly to a person’s face.  The surgical mask creates better filtration.

Ms. Marr said KN94 or KN95 masks, which are being manufactured in China and Korea, are good choices. They offer nearly the same degree of filtration as an N95, and they fit closely to the face, to minimize leaks.
 

 

 

Check for counterfeits

The KN94 and KN95 masks for children are widely available, but Ms. Marr said parents do need to watch out for counterfeits, which don’t perform as well.

The National Institute for Occupational Safety and Health gives examples of counterfeit products here.

There’s also a type of cloth mask that has a built-in, edge-to-edge filter layer that is made for children.

“Some of these filter out more than 99% of particles and those can be very effective, if they fit well,” Ms. Marr said.

She has compiled and publicly posted a list of her recommendations for masks for children.

There’s also a new standard for face masks. It’s called ASTM F3502-21, and it’s published by an international organization that sets voluntary standards for thousands of products. To claim that a mask meets this standard, a manufacturer has to have its mask tested and demonstrate that it provides a certain level of filtration and breathability.

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

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One essential back-to-school item for children this fall is a face mask – the Centers for Disease Control and Prevention and the American Academy of Pediatrics both recommend them – but finding one that’s actually protective for a child is not a straightforward task, as many parents can attest. 

There’s little in the way of official guidance or research to inform evidence-based recommendations on what type of face masks works best for children. 

Search for children’s face masks on Amazon and you’ll run into a smorgasbord of options: masks with three, four, or five layers, different designs, and different materials. There’s one company selling a mask it calls an m95 model, a term the company devised. 

It’s almost impossible to verify many of the claims being made by the manufacturers, or to know if they will fit your child’s face until you order some, which can get expensive.

But it’s worth looking for a good mask.  A large study of more than 1 million people being conducted online by Facebook and Carnegie Mellon University found that students who wore face masks in school had a reduced risk for testing positive for the virus and getting sick with COVID-19 symptoms. The study was published in June in the journal Science.
 

Delta more contagious

The Delta variant of the new coronavirus is much more contagious than previous versions of the virus. Studies have shown that infected people carry 1,000 times more virus in their noses and throats than with the viruses that circulated last winter and spring. They shed more viral particles into the air when they talk or yell or sing, making this COVID-19–causing virus much more transmissible than in the past.

What that means, says Kimberly Prather, PhD, an aerosol scientist and distinguished professor at the Scripps Institution of Oceanography in La Jolla, California, is that if it once took about 15 minutes of proximity to an infected person to catch the infection, that window of risk is now much shorter.

“If you believe the 15-minute magical number, now if you take 1,000 times the viral load, basically in 1 second you could inhale that same amount of virus. So it’s gone from 15 minutes to 1 second,” Dr. Prather said in an online seminar on school safety she helped to organize. 
 

A better mask

What that means is that we need to upgrade our face masks, switching away from ill-fitting fabric masks, which can offer varying degrees of protection depending on the number of layers and type of fabric that’s used, to more highly protective surgical masks or better yet, N95 respirators, which provide the highest level of filtration.

That’s harder to do for children, who have much smaller faces.

Any masks that gapes around the edges isn’t going to work well, no matter how well it filters.

“N95s are not made to fit kids. They do not come in kid sizes, so I do not recommend N95s for kids,” said Linsey Marr, an environmental engineer at Virginia Tech, who tests face masks in her lab.

Ms. Marr says parents need to consider the attributes masks in this order of priority: 

Comfort: “If your kid won’t wear it, it’s not helping at all,” she said.

Fit: “Leaks around the sides are like having a hole in your mask and aerosols carrying the virus can get right through,” Ms. Marr said.

Filtration: How well the mask blocks small particles.

One option to improve fit is to layer a fabric mask over a surgical mask. The fabric mask helps to hold the edges of the surgical mask more tightly to a person’s face.  The surgical mask creates better filtration.

Ms. Marr said KN94 or KN95 masks, which are being manufactured in China and Korea, are good choices. They offer nearly the same degree of filtration as an N95, and they fit closely to the face, to minimize leaks.
 

 

 

Check for counterfeits

The KN94 and KN95 masks for children are widely available, but Ms. Marr said parents do need to watch out for counterfeits, which don’t perform as well.

The National Institute for Occupational Safety and Health gives examples of counterfeit products here.

There’s also a type of cloth mask that has a built-in, edge-to-edge filter layer that is made for children.

“Some of these filter out more than 99% of particles and those can be very effective, if they fit well,” Ms. Marr said.

She has compiled and publicly posted a list of her recommendations for masks for children.

There’s also a new standard for face masks. It’s called ASTM F3502-21, and it’s published by an international organization that sets voluntary standards for thousands of products. To claim that a mask meets this standard, a manufacturer has to have its mask tested and demonstrate that it provides a certain level of filtration and breathability.

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

 

One essential back-to-school item for children this fall is a face mask – the Centers for Disease Control and Prevention and the American Academy of Pediatrics both recommend them – but finding one that’s actually protective for a child is not a straightforward task, as many parents can attest. 

There’s little in the way of official guidance or research to inform evidence-based recommendations on what type of face masks works best for children. 

Search for children’s face masks on Amazon and you’ll run into a smorgasbord of options: masks with three, four, or five layers, different designs, and different materials. There’s one company selling a mask it calls an m95 model, a term the company devised. 

It’s almost impossible to verify many of the claims being made by the manufacturers, or to know if they will fit your child’s face until you order some, which can get expensive.

But it’s worth looking for a good mask.  A large study of more than 1 million people being conducted online by Facebook and Carnegie Mellon University found that students who wore face masks in school had a reduced risk for testing positive for the virus and getting sick with COVID-19 symptoms. The study was published in June in the journal Science.
 

Delta more contagious

The Delta variant of the new coronavirus is much more contagious than previous versions of the virus. Studies have shown that infected people carry 1,000 times more virus in their noses and throats than with the viruses that circulated last winter and spring. They shed more viral particles into the air when they talk or yell or sing, making this COVID-19–causing virus much more transmissible than in the past.

What that means, says Kimberly Prather, PhD, an aerosol scientist and distinguished professor at the Scripps Institution of Oceanography in La Jolla, California, is that if it once took about 15 minutes of proximity to an infected person to catch the infection, that window of risk is now much shorter.

“If you believe the 15-minute magical number, now if you take 1,000 times the viral load, basically in 1 second you could inhale that same amount of virus. So it’s gone from 15 minutes to 1 second,” Dr. Prather said in an online seminar on school safety she helped to organize. 
 

A better mask

What that means is that we need to upgrade our face masks, switching away from ill-fitting fabric masks, which can offer varying degrees of protection depending on the number of layers and type of fabric that’s used, to more highly protective surgical masks or better yet, N95 respirators, which provide the highest level of filtration.

That’s harder to do for children, who have much smaller faces.

Any masks that gapes around the edges isn’t going to work well, no matter how well it filters.

“N95s are not made to fit kids. They do not come in kid sizes, so I do not recommend N95s for kids,” said Linsey Marr, an environmental engineer at Virginia Tech, who tests face masks in her lab.

Ms. Marr says parents need to consider the attributes masks in this order of priority: 

Comfort: “If your kid won’t wear it, it’s not helping at all,” she said.

Fit: “Leaks around the sides are like having a hole in your mask and aerosols carrying the virus can get right through,” Ms. Marr said.

Filtration: How well the mask blocks small particles.

One option to improve fit is to layer a fabric mask over a surgical mask. The fabric mask helps to hold the edges of the surgical mask more tightly to a person’s face.  The surgical mask creates better filtration.

Ms. Marr said KN94 or KN95 masks, which are being manufactured in China and Korea, are good choices. They offer nearly the same degree of filtration as an N95, and they fit closely to the face, to minimize leaks.
 

 

 

Check for counterfeits

The KN94 and KN95 masks for children are widely available, but Ms. Marr said parents do need to watch out for counterfeits, which don’t perform as well.

The National Institute for Occupational Safety and Health gives examples of counterfeit products here.

There’s also a type of cloth mask that has a built-in, edge-to-edge filter layer that is made for children.

“Some of these filter out more than 99% of particles and those can be very effective, if they fit well,” Ms. Marr said.

She has compiled and publicly posted a list of her recommendations for masks for children.

There’s also a new standard for face masks. It’s called ASTM F3502-21, and it’s published by an international organization that sets voluntary standards for thousands of products. To claim that a mask meets this standard, a manufacturer has to have its mask tested and demonstrate that it provides a certain level of filtration and breathability.

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

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Why are boosters being given after 8 months? Experts weigh in

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Thu, 08/26/2021 - 15:43

Following the White House administration’s announcement to start booster COVID-19 vaccinations for American adults in September, experts weighed in on the evidence for choosing an 8-month cutoff, how breakthrough infections figure in, and why calling one mRNA vaccine better than the other could be misleading.

Timing came up more than once at the Aug. 18 White House briefing announcing the booster plans. Reporters asked about the start time of Sept. 20 and people waiting at least 8 months after their second mRNA vaccine dose to get a booster.

Anthony Fauci, MD, chief medical adviser to the president and director of the National Institute of Allergy and Infectious Diseases, explained that late September gives the United States time to set up the logistics.

Centers for Disease Control and Prevention Director Rochelle Walensky, MD, MPH, added that 8 months is in part based on data from Israel and other countries on the waning of vaccine effectiveness over time.

“It is possible that 8 [months] is associated with the amount of time that we’ve been able to follow large groups of people, especially those who are 65 and older,” Julie Swann, PhD, said during a subsequent media briefing sponsored by Newswise on Aug. 18. “I know that Pfizer has said that they think a booster sometime between 6 and 12 months would be reasonable.”

Dr. Swann supported the administration’s booster shots plan. She said it is important “that we continue to get people the full amount of protection if it’s recommended by CDC and ACIP [Advisory Committee on Immunization Practices] that would come from a booster shot.” Dr. Swann is department head and A. Doug Allison Distinguished Professor at North Carolina State University and an adjunct professor in the joint department of biomedical engineering at the University of North Carolina at Chapel Hill. 
 

Rising importance of breakthrough cases

Also on Aug. 18, news emerged that breakthrough cases are on the rise in seven U.S. states, likely because of the Delta variant.

These SARS-CoV-2 infections among the fully vaccinated account for 20% of cases in six of the seven states cited in a New York Times report, for example. Researchers also suggested that hospitalization and deaths associated with breakthrough cases could be higher than previously appreciated.

“It is expected that over time we will see more cases of Delta variant infections among vaccinated people. This points toward the need for booster vaccines and/or eventual modifications to the vaccine to capture new variants in the future,” Juan Wisnivesky, MD, DrPH, chief of the division of general internal medicine at Mount Sinai Health System in New York City, said during the briefing.
 

Vaccine comparisons unfair?

Following the release of a Mayo Clinic study reporting lower effectiveness of the Pfizer mRNA vaccine at 42% versus 76% for the Moderna product, some people started asking if one vaccine was better than the other.

“To begin with, the vaccines are not being compared side-by-side,” Dr. Wisnivesky said. “So we only know the effectiveness of each vaccine versus placebo, but we don’t know one versus the other.”

He added that different study designs, different populations, and other factors make direct comparisons difficult.

More evidence will be needed, Dr. Wisnivesky said, before public health officials can recommend that someone who received one mRNA vaccine switch to another for their booster shot.
 

 

 

Layering protections

Continuing to recommend masks is essential, Dr. Swann added. “With this Delta variant, it does appear that the possibility of reinfection or of a disease case breaking through vaccination can occur. So that makes it even more important to consider using nonpharmaceutical interventions while we continue to vaccinate people.”

Wearing or not wearing a mask is one of the behaviors that drive the transmission of disease, Dr. Swann said.

“What we saw across the board is that many people really wanted to go back to normal as much as they could. And we went back to normal a little bit too soon, especially given this new version of the virus that was circulating,” she said.
 

In poll, most favor boosters

A recent poll conducted by Medscape indicates that a majority of vaccinated physicians and nurses are ready and willing to take a COVID-19 booster vaccine. For example, 93% of 943 doctors and 87% of 1,680 nurses who responded want booster shots, either immediately or when they are authorized and recommended.

Among 510 WebMD readers responding to a similar poll, 82% indicated they wanted a booster shot.
 

A challenging task lies ahead

According to CDC data, as of Aug. 18, 2021, almost 169 million Americans are fully vaccinated, including the one-shot Johnson & Johnson adenovirus vaccine.

“I think it will be a challenge to get everyone who is fully vaccinated to come in for that booster,” Dr. Swann said.

Logistically speaking, Dr. Swann explained that many sites that were open for initial vaccinations, including drive-up locations and 24/7 vaccination sites, are no longer operating.

“We might see that rollout look a little bit differently. You might be able to go to your pharmacy or go to your primary care physician,” she said.

“But we may not see as many weekend events so it is going to be easier to get some people a booster than others.

“One interesting thing will also be whether a booster is effective in actually preventing you from giving a disease to someone else,” Dr. Swann said. “That could make a difference as well, because that might play into whether companies, hospitals, universities, or others require a booster.”

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

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Following the White House administration’s announcement to start booster COVID-19 vaccinations for American adults in September, experts weighed in on the evidence for choosing an 8-month cutoff, how breakthrough infections figure in, and why calling one mRNA vaccine better than the other could be misleading.

Timing came up more than once at the Aug. 18 White House briefing announcing the booster plans. Reporters asked about the start time of Sept. 20 and people waiting at least 8 months after their second mRNA vaccine dose to get a booster.

Anthony Fauci, MD, chief medical adviser to the president and director of the National Institute of Allergy and Infectious Diseases, explained that late September gives the United States time to set up the logistics.

Centers for Disease Control and Prevention Director Rochelle Walensky, MD, MPH, added that 8 months is in part based on data from Israel and other countries on the waning of vaccine effectiveness over time.

“It is possible that 8 [months] is associated with the amount of time that we’ve been able to follow large groups of people, especially those who are 65 and older,” Julie Swann, PhD, said during a subsequent media briefing sponsored by Newswise on Aug. 18. “I know that Pfizer has said that they think a booster sometime between 6 and 12 months would be reasonable.”

Dr. Swann supported the administration’s booster shots plan. She said it is important “that we continue to get people the full amount of protection if it’s recommended by CDC and ACIP [Advisory Committee on Immunization Practices] that would come from a booster shot.” Dr. Swann is department head and A. Doug Allison Distinguished Professor at North Carolina State University and an adjunct professor in the joint department of biomedical engineering at the University of North Carolina at Chapel Hill. 
 

Rising importance of breakthrough cases

Also on Aug. 18, news emerged that breakthrough cases are on the rise in seven U.S. states, likely because of the Delta variant.

These SARS-CoV-2 infections among the fully vaccinated account for 20% of cases in six of the seven states cited in a New York Times report, for example. Researchers also suggested that hospitalization and deaths associated with breakthrough cases could be higher than previously appreciated.

“It is expected that over time we will see more cases of Delta variant infections among vaccinated people. This points toward the need for booster vaccines and/or eventual modifications to the vaccine to capture new variants in the future,” Juan Wisnivesky, MD, DrPH, chief of the division of general internal medicine at Mount Sinai Health System in New York City, said during the briefing.
 

Vaccine comparisons unfair?

Following the release of a Mayo Clinic study reporting lower effectiveness of the Pfizer mRNA vaccine at 42% versus 76% for the Moderna product, some people started asking if one vaccine was better than the other.

“To begin with, the vaccines are not being compared side-by-side,” Dr. Wisnivesky said. “So we only know the effectiveness of each vaccine versus placebo, but we don’t know one versus the other.”

He added that different study designs, different populations, and other factors make direct comparisons difficult.

More evidence will be needed, Dr. Wisnivesky said, before public health officials can recommend that someone who received one mRNA vaccine switch to another for their booster shot.
 

 

 

Layering protections

Continuing to recommend masks is essential, Dr. Swann added. “With this Delta variant, it does appear that the possibility of reinfection or of a disease case breaking through vaccination can occur. So that makes it even more important to consider using nonpharmaceutical interventions while we continue to vaccinate people.”

Wearing or not wearing a mask is one of the behaviors that drive the transmission of disease, Dr. Swann said.

“What we saw across the board is that many people really wanted to go back to normal as much as they could. And we went back to normal a little bit too soon, especially given this new version of the virus that was circulating,” she said.
 

In poll, most favor boosters

A recent poll conducted by Medscape indicates that a majority of vaccinated physicians and nurses are ready and willing to take a COVID-19 booster vaccine. For example, 93% of 943 doctors and 87% of 1,680 nurses who responded want booster shots, either immediately or when they are authorized and recommended.

Among 510 WebMD readers responding to a similar poll, 82% indicated they wanted a booster shot.
 

A challenging task lies ahead

According to CDC data, as of Aug. 18, 2021, almost 169 million Americans are fully vaccinated, including the one-shot Johnson & Johnson adenovirus vaccine.

“I think it will be a challenge to get everyone who is fully vaccinated to come in for that booster,” Dr. Swann said.

Logistically speaking, Dr. Swann explained that many sites that were open for initial vaccinations, including drive-up locations and 24/7 vaccination sites, are no longer operating.

“We might see that rollout look a little bit differently. You might be able to go to your pharmacy or go to your primary care physician,” she said.

“But we may not see as many weekend events so it is going to be easier to get some people a booster than others.

“One interesting thing will also be whether a booster is effective in actually preventing you from giving a disease to someone else,” Dr. Swann said. “That could make a difference as well, because that might play into whether companies, hospitals, universities, or others require a booster.”

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

Following the White House administration’s announcement to start booster COVID-19 vaccinations for American adults in September, experts weighed in on the evidence for choosing an 8-month cutoff, how breakthrough infections figure in, and why calling one mRNA vaccine better than the other could be misleading.

Timing came up more than once at the Aug. 18 White House briefing announcing the booster plans. Reporters asked about the start time of Sept. 20 and people waiting at least 8 months after their second mRNA vaccine dose to get a booster.

Anthony Fauci, MD, chief medical adviser to the president and director of the National Institute of Allergy and Infectious Diseases, explained that late September gives the United States time to set up the logistics.

Centers for Disease Control and Prevention Director Rochelle Walensky, MD, MPH, added that 8 months is in part based on data from Israel and other countries on the waning of vaccine effectiveness over time.

“It is possible that 8 [months] is associated with the amount of time that we’ve been able to follow large groups of people, especially those who are 65 and older,” Julie Swann, PhD, said during a subsequent media briefing sponsored by Newswise on Aug. 18. “I know that Pfizer has said that they think a booster sometime between 6 and 12 months would be reasonable.”

Dr. Swann supported the administration’s booster shots plan. She said it is important “that we continue to get people the full amount of protection if it’s recommended by CDC and ACIP [Advisory Committee on Immunization Practices] that would come from a booster shot.” Dr. Swann is department head and A. Doug Allison Distinguished Professor at North Carolina State University and an adjunct professor in the joint department of biomedical engineering at the University of North Carolina at Chapel Hill. 
 

Rising importance of breakthrough cases

Also on Aug. 18, news emerged that breakthrough cases are on the rise in seven U.S. states, likely because of the Delta variant.

These SARS-CoV-2 infections among the fully vaccinated account for 20% of cases in six of the seven states cited in a New York Times report, for example. Researchers also suggested that hospitalization and deaths associated with breakthrough cases could be higher than previously appreciated.

“It is expected that over time we will see more cases of Delta variant infections among vaccinated people. This points toward the need for booster vaccines and/or eventual modifications to the vaccine to capture new variants in the future,” Juan Wisnivesky, MD, DrPH, chief of the division of general internal medicine at Mount Sinai Health System in New York City, said during the briefing.
 

Vaccine comparisons unfair?

Following the release of a Mayo Clinic study reporting lower effectiveness of the Pfizer mRNA vaccine at 42% versus 76% for the Moderna product, some people started asking if one vaccine was better than the other.

“To begin with, the vaccines are not being compared side-by-side,” Dr. Wisnivesky said. “So we only know the effectiveness of each vaccine versus placebo, but we don’t know one versus the other.”

He added that different study designs, different populations, and other factors make direct comparisons difficult.

More evidence will be needed, Dr. Wisnivesky said, before public health officials can recommend that someone who received one mRNA vaccine switch to another for their booster shot.
 

 

 

Layering protections

Continuing to recommend masks is essential, Dr. Swann added. “With this Delta variant, it does appear that the possibility of reinfection or of a disease case breaking through vaccination can occur. So that makes it even more important to consider using nonpharmaceutical interventions while we continue to vaccinate people.”

Wearing or not wearing a mask is one of the behaviors that drive the transmission of disease, Dr. Swann said.

“What we saw across the board is that many people really wanted to go back to normal as much as they could. And we went back to normal a little bit too soon, especially given this new version of the virus that was circulating,” she said.
 

In poll, most favor boosters

A recent poll conducted by Medscape indicates that a majority of vaccinated physicians and nurses are ready and willing to take a COVID-19 booster vaccine. For example, 93% of 943 doctors and 87% of 1,680 nurses who responded want booster shots, either immediately or when they are authorized and recommended.

Among 510 WebMD readers responding to a similar poll, 82% indicated they wanted a booster shot.
 

A challenging task lies ahead

According to CDC data, as of Aug. 18, 2021, almost 169 million Americans are fully vaccinated, including the one-shot Johnson & Johnson adenovirus vaccine.

“I think it will be a challenge to get everyone who is fully vaccinated to come in for that booster,” Dr. Swann said.

Logistically speaking, Dr. Swann explained that many sites that were open for initial vaccinations, including drive-up locations and 24/7 vaccination sites, are no longer operating.

“We might see that rollout look a little bit differently. You might be able to go to your pharmacy or go to your primary care physician,” she said.

“But we may not see as many weekend events so it is going to be easier to get some people a booster than others.

“One interesting thing will also be whether a booster is effective in actually preventing you from giving a disease to someone else,” Dr. Swann said. “That could make a difference as well, because that might play into whether companies, hospitals, universities, or others require a booster.”

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

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Medicinal liquor and edited mosquitoes

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Thu, 08/19/2021 - 10:45

 

Drink to your health?

Whether you drink or not, most of us can agree that liquor is not the first thing that comes to mind when looking to make health improvements. But researchers have found a small exception in something traditional.

Xvision/Moment

We’ve added buckwheat to pancakes, bread, and other baked goodies we made during the height of quarantine, but it’s also used to create a traditional liquor in some East Asian countries, where it is used medicinally.

Investigators have found that extracts in the Tartary buckwheat used to make the liquor induce autophagy, a process cells go through to remove proteins that are damaged or not needed anymore – sort of like a cellular spring cleaning.

To test this, the researchers treated liver and skin cells with Tartary buckwheat extract and looked to see how the cells responded with fluorescent markers. The results were clear.

“Treating cells with the extract stimulated the formation of autophagosomes, specialized cellular structures that carry out autophagy, and altered the location of proteins involved in regulating autophagy,” said senior author Takeshi Noda of Osaka (Japan) University.

Looking deeper, the researchers found that quercetin, a component of the buckwheat extract, had the same autophagic effect. And both the buckwheat and the quercetin gave the green light for liver cells to induce aggrephagy, the process of cleaning up protein aggregates.

Those protein aggregates in liver cells are closely linked to alcoholic liver disease, suggesting that quercetin could be a game changer in its treatment. In other words, liquor could help fix the problem that liquor started. Go figure.
 

From hospital bills to X-rated

Ralph Puglisi was an accounting manager for the University Medical Service Association (UMSA), a nonprofit that supports the massive University of South Florida health system. The association took in over $300 million in revenue in the 2019-2020 fiscal year, which is a rather large sum of money, but we’ll glide over the ethics of a “nonprofit” making a few hundred million for now.

wakila/Getty Images

Mr. Puglisi was in very close proximity to the money, generated from patient care, and he pled guilty to stealing it using UMSA credit cards. Now, that wouldn’t be LOTME worthy on its own, but what elevates this above garden-variety embezzlement is how the intrepid Mr. Puglisi chose to spend the millions he stole from the university health system: Adult entertainment.

And before you ask, he didn’t spend $11.5 million on something most people so inclined can find for free with judicious Google searches. What Mr. Puglisi actually did was invest in a website providing adult content through individual user profiles, one of which is believed to belong to his stepson’s fiancée, which brings a whole new level of sleaze to this enterprise. Over the course of 2 years, he visited her profile 2,800 times, an amount some might view as excessive.

While the vast majority of the embezzled money went to the adult website, Mr. Puglisi also used thousands of UMSA dollars to pay for travel, household improvements, rent, the works. Almost $44,000 was spent at a resort sometimes known as the happiest place on earth.

Then there’s Mr. Puglisi’s wife. Oh yes, this guy is married. He poured over $600,000 into a company he and his wife owned, which is a lot, but how much do you think went to the woman he married? Probably quite a bit. Go ahead, try to think of a number. It’s not like it was his money.

Did you guess $100 went into his wife’s PayPal account? No? Clearly you don’t understand the criminal mind. His stepson’s fiancée got millions, and his wife got a hundred. Now there are some priorities.
 

 

 

Step 1: Sit at desk. Step 2: Get in shape

Being a physician is not really a desk job, but doctors must spend a fair share of their time sitting, yes? Dealing with recalcitrant EHRs or talking on the phone to insurers or PBMs? If you are one of these physicians, or if you have patients who spend a lot of time sitting at their desks and might need to get a bit of exercise, then we’ve got a multitasking tip for you.

Mohamed Hassan/pxhere

It came to us via one of our favorite websites, Sad and Useless. It’s the site that declares itself “the most depressive humor site on the Internet” and they’re offering up the “12 Best Exercises To Do At Your Desk.” It may not sound like much, but we think that the gang at Dunder-Mifflin would approve. And besides, who couldn’t stand to burn a few calories without having to leave the chair?

We won’t spoil your fun by going through all 12 – each one comes with step-by-step instructions and a helpful illustration or GIF – but here are just a few:

  • Bending over backwards: “Agree to do something you don’t want to do. Spend twice as long as expected doing that thing. Hate yourself.”
  • Fake laughter: “Hear a joke that isn’t even remotely funny. Open your mouth and make laughing sounds.”
  • Bang your head: Feel the “pointlessness of your job overwhelm you” and then “bring your head forcefully down to your desk.”

Now, we here at LOTME are, of course [Bang!], highly skilled, professional wordsmithing humorists [Bang!], so when we tell you that this is a great workout [Bang!] … that this is a great workout [Bang!] … it’s great … uggh.

Wooooo. Feel the burn.
 

One order of mosquitoes, extra Crispr

What would it be like to have a barbecue in your backyard on a humid summer night and not get eaten alive by mosquitoes? If you’re like us, you probably thought you’d never see that day.

©TacioPhilip/Thinkstock

Mosquitoes cause itchy bites, but, more importantly, they can carry dengue, malaria, yellow fever, and Zika virus. New research shows that protection from these diseases may be possible with use of the Crispr-Cas9 gene-editing tool, which could make humans invisible to mosquitoes by taking away their light-sensing abilities and, thus, their ability to find us.

“The better we understand how they sense the human, the better we can control the mosquito in an eco-friendly manner,” Yinpeng Zhan, a postdoctoral researcher at the University of California, Santa Barbara, and the study’s lead author, told the New York Times.

After studying the mosquitoes and figuring out their hunting patterns, the researchers found that mosquitoes are attracted to dark spots more than white spots and used this to their advantage. After knocking out two of the proteins that mosquitoes need for vision – via Crispr – the little suckers could not distinguish the difference between the white and dark spots.

We’re sure mosquitoes don’t mean any harm – they’re just trying to survive and reproduce like any other species – but thanks to this new tool, gone might be the days of having to douse yourself in bug spray that smells like a mix of chemicals and melon.

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Topics
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Drink to your health?

Whether you drink or not, most of us can agree that liquor is not the first thing that comes to mind when looking to make health improvements. But researchers have found a small exception in something traditional.

Xvision/Moment

We’ve added buckwheat to pancakes, bread, and other baked goodies we made during the height of quarantine, but it’s also used to create a traditional liquor in some East Asian countries, where it is used medicinally.

Investigators have found that extracts in the Tartary buckwheat used to make the liquor induce autophagy, a process cells go through to remove proteins that are damaged or not needed anymore – sort of like a cellular spring cleaning.

To test this, the researchers treated liver and skin cells with Tartary buckwheat extract and looked to see how the cells responded with fluorescent markers. The results were clear.

“Treating cells with the extract stimulated the formation of autophagosomes, specialized cellular structures that carry out autophagy, and altered the location of proteins involved in regulating autophagy,” said senior author Takeshi Noda of Osaka (Japan) University.

Looking deeper, the researchers found that quercetin, a component of the buckwheat extract, had the same autophagic effect. And both the buckwheat and the quercetin gave the green light for liver cells to induce aggrephagy, the process of cleaning up protein aggregates.

Those protein aggregates in liver cells are closely linked to alcoholic liver disease, suggesting that quercetin could be a game changer in its treatment. In other words, liquor could help fix the problem that liquor started. Go figure.
 

From hospital bills to X-rated

Ralph Puglisi was an accounting manager for the University Medical Service Association (UMSA), a nonprofit that supports the massive University of South Florida health system. The association took in over $300 million in revenue in the 2019-2020 fiscal year, which is a rather large sum of money, but we’ll glide over the ethics of a “nonprofit” making a few hundred million for now.

wakila/Getty Images

Mr. Puglisi was in very close proximity to the money, generated from patient care, and he pled guilty to stealing it using UMSA credit cards. Now, that wouldn’t be LOTME worthy on its own, but what elevates this above garden-variety embezzlement is how the intrepid Mr. Puglisi chose to spend the millions he stole from the university health system: Adult entertainment.

And before you ask, he didn’t spend $11.5 million on something most people so inclined can find for free with judicious Google searches. What Mr. Puglisi actually did was invest in a website providing adult content through individual user profiles, one of which is believed to belong to his stepson’s fiancée, which brings a whole new level of sleaze to this enterprise. Over the course of 2 years, he visited her profile 2,800 times, an amount some might view as excessive.

While the vast majority of the embezzled money went to the adult website, Mr. Puglisi also used thousands of UMSA dollars to pay for travel, household improvements, rent, the works. Almost $44,000 was spent at a resort sometimes known as the happiest place on earth.

Then there’s Mr. Puglisi’s wife. Oh yes, this guy is married. He poured over $600,000 into a company he and his wife owned, which is a lot, but how much do you think went to the woman he married? Probably quite a bit. Go ahead, try to think of a number. It’s not like it was his money.

Did you guess $100 went into his wife’s PayPal account? No? Clearly you don’t understand the criminal mind. His stepson’s fiancée got millions, and his wife got a hundred. Now there are some priorities.
 

 

 

Step 1: Sit at desk. Step 2: Get in shape

Being a physician is not really a desk job, but doctors must spend a fair share of their time sitting, yes? Dealing with recalcitrant EHRs or talking on the phone to insurers or PBMs? If you are one of these physicians, or if you have patients who spend a lot of time sitting at their desks and might need to get a bit of exercise, then we’ve got a multitasking tip for you.

Mohamed Hassan/pxhere

It came to us via one of our favorite websites, Sad and Useless. It’s the site that declares itself “the most depressive humor site on the Internet” and they’re offering up the “12 Best Exercises To Do At Your Desk.” It may not sound like much, but we think that the gang at Dunder-Mifflin would approve. And besides, who couldn’t stand to burn a few calories without having to leave the chair?

We won’t spoil your fun by going through all 12 – each one comes with step-by-step instructions and a helpful illustration or GIF – but here are just a few:

  • Bending over backwards: “Agree to do something you don’t want to do. Spend twice as long as expected doing that thing. Hate yourself.”
  • Fake laughter: “Hear a joke that isn’t even remotely funny. Open your mouth and make laughing sounds.”
  • Bang your head: Feel the “pointlessness of your job overwhelm you” and then “bring your head forcefully down to your desk.”

Now, we here at LOTME are, of course [Bang!], highly skilled, professional wordsmithing humorists [Bang!], so when we tell you that this is a great workout [Bang!] … that this is a great workout [Bang!] … it’s great … uggh.

Wooooo. Feel the burn.
 

One order of mosquitoes, extra Crispr

What would it be like to have a barbecue in your backyard on a humid summer night and not get eaten alive by mosquitoes? If you’re like us, you probably thought you’d never see that day.

©TacioPhilip/Thinkstock

Mosquitoes cause itchy bites, but, more importantly, they can carry dengue, malaria, yellow fever, and Zika virus. New research shows that protection from these diseases may be possible with use of the Crispr-Cas9 gene-editing tool, which could make humans invisible to mosquitoes by taking away their light-sensing abilities and, thus, their ability to find us.

“The better we understand how they sense the human, the better we can control the mosquito in an eco-friendly manner,” Yinpeng Zhan, a postdoctoral researcher at the University of California, Santa Barbara, and the study’s lead author, told the New York Times.

After studying the mosquitoes and figuring out their hunting patterns, the researchers found that mosquitoes are attracted to dark spots more than white spots and used this to their advantage. After knocking out two of the proteins that mosquitoes need for vision – via Crispr – the little suckers could not distinguish the difference between the white and dark spots.

We’re sure mosquitoes don’t mean any harm – they’re just trying to survive and reproduce like any other species – but thanks to this new tool, gone might be the days of having to douse yourself in bug spray that smells like a mix of chemicals and melon.

 

Drink to your health?

Whether you drink or not, most of us can agree that liquor is not the first thing that comes to mind when looking to make health improvements. But researchers have found a small exception in something traditional.

Xvision/Moment

We’ve added buckwheat to pancakes, bread, and other baked goodies we made during the height of quarantine, but it’s also used to create a traditional liquor in some East Asian countries, where it is used medicinally.

Investigators have found that extracts in the Tartary buckwheat used to make the liquor induce autophagy, a process cells go through to remove proteins that are damaged or not needed anymore – sort of like a cellular spring cleaning.

To test this, the researchers treated liver and skin cells with Tartary buckwheat extract and looked to see how the cells responded with fluorescent markers. The results were clear.

“Treating cells with the extract stimulated the formation of autophagosomes, specialized cellular structures that carry out autophagy, and altered the location of proteins involved in regulating autophagy,” said senior author Takeshi Noda of Osaka (Japan) University.

Looking deeper, the researchers found that quercetin, a component of the buckwheat extract, had the same autophagic effect. And both the buckwheat and the quercetin gave the green light for liver cells to induce aggrephagy, the process of cleaning up protein aggregates.

Those protein aggregates in liver cells are closely linked to alcoholic liver disease, suggesting that quercetin could be a game changer in its treatment. In other words, liquor could help fix the problem that liquor started. Go figure.
 

From hospital bills to X-rated

Ralph Puglisi was an accounting manager for the University Medical Service Association (UMSA), a nonprofit that supports the massive University of South Florida health system. The association took in over $300 million in revenue in the 2019-2020 fiscal year, which is a rather large sum of money, but we’ll glide over the ethics of a “nonprofit” making a few hundred million for now.

wakila/Getty Images

Mr. Puglisi was in very close proximity to the money, generated from patient care, and he pled guilty to stealing it using UMSA credit cards. Now, that wouldn’t be LOTME worthy on its own, but what elevates this above garden-variety embezzlement is how the intrepid Mr. Puglisi chose to spend the millions he stole from the university health system: Adult entertainment.

And before you ask, he didn’t spend $11.5 million on something most people so inclined can find for free with judicious Google searches. What Mr. Puglisi actually did was invest in a website providing adult content through individual user profiles, one of which is believed to belong to his stepson’s fiancée, which brings a whole new level of sleaze to this enterprise. Over the course of 2 years, he visited her profile 2,800 times, an amount some might view as excessive.

While the vast majority of the embezzled money went to the adult website, Mr. Puglisi also used thousands of UMSA dollars to pay for travel, household improvements, rent, the works. Almost $44,000 was spent at a resort sometimes known as the happiest place on earth.

Then there’s Mr. Puglisi’s wife. Oh yes, this guy is married. He poured over $600,000 into a company he and his wife owned, which is a lot, but how much do you think went to the woman he married? Probably quite a bit. Go ahead, try to think of a number. It’s not like it was his money.

Did you guess $100 went into his wife’s PayPal account? No? Clearly you don’t understand the criminal mind. His stepson’s fiancée got millions, and his wife got a hundred. Now there are some priorities.
 

 

 

Step 1: Sit at desk. Step 2: Get in shape

Being a physician is not really a desk job, but doctors must spend a fair share of their time sitting, yes? Dealing with recalcitrant EHRs or talking on the phone to insurers or PBMs? If you are one of these physicians, or if you have patients who spend a lot of time sitting at their desks and might need to get a bit of exercise, then we’ve got a multitasking tip for you.

Mohamed Hassan/pxhere

It came to us via one of our favorite websites, Sad and Useless. It’s the site that declares itself “the most depressive humor site on the Internet” and they’re offering up the “12 Best Exercises To Do At Your Desk.” It may not sound like much, but we think that the gang at Dunder-Mifflin would approve. And besides, who couldn’t stand to burn a few calories without having to leave the chair?

We won’t spoil your fun by going through all 12 – each one comes with step-by-step instructions and a helpful illustration or GIF – but here are just a few:

  • Bending over backwards: “Agree to do something you don’t want to do. Spend twice as long as expected doing that thing. Hate yourself.”
  • Fake laughter: “Hear a joke that isn’t even remotely funny. Open your mouth and make laughing sounds.”
  • Bang your head: Feel the “pointlessness of your job overwhelm you” and then “bring your head forcefully down to your desk.”

Now, we here at LOTME are, of course [Bang!], highly skilled, professional wordsmithing humorists [Bang!], so when we tell you that this is a great workout [Bang!] … that this is a great workout [Bang!] … it’s great … uggh.

Wooooo. Feel the burn.
 

One order of mosquitoes, extra Crispr

What would it be like to have a barbecue in your backyard on a humid summer night and not get eaten alive by mosquitoes? If you’re like us, you probably thought you’d never see that day.

©TacioPhilip/Thinkstock

Mosquitoes cause itchy bites, but, more importantly, they can carry dengue, malaria, yellow fever, and Zika virus. New research shows that protection from these diseases may be possible with use of the Crispr-Cas9 gene-editing tool, which could make humans invisible to mosquitoes by taking away their light-sensing abilities and, thus, their ability to find us.

“The better we understand how they sense the human, the better we can control the mosquito in an eco-friendly manner,” Yinpeng Zhan, a postdoctoral researcher at the University of California, Santa Barbara, and the study’s lead author, told the New York Times.

After studying the mosquitoes and figuring out their hunting patterns, the researchers found that mosquitoes are attracted to dark spots more than white spots and used this to their advantage. After knocking out two of the proteins that mosquitoes need for vision – via Crispr – the little suckers could not distinguish the difference between the white and dark spots.

We’re sure mosquitoes don’t mean any harm – they’re just trying to survive and reproduce like any other species – but thanks to this new tool, gone might be the days of having to douse yourself in bug spray that smells like a mix of chemicals and melon.

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COVID-19 booster shots to start in September: Officials

Article Type
Changed
Thu, 08/26/2021 - 15:43

Booster shots to ramp up protection against COVID-19 infection are slated to begin the week of Sept. 20, the Biden administration announced at a press briefing August 18.

Those who received the Pfizer-BioNTech and Moderna vaccines would be eligible to get a booster shot 8 months after they received the second dose of those vaccines, officials said. Information on boosters for those who got the one-dose Johnson & Johnson vaccine will be forthcoming.

“We anticipate a booster will [also] likely be needed,” said U.S. Surgeon General Vivek Murthy, MD. The J&J vaccine was not available in the U.S. until March, he said, and ‘’we expect more data on J&J in the coming weeks, so that plan is coming.”

The plan for boosters for the two mRNA vaccines is pending the FDA’s conducting of an independent review and authorizing the third dose of the Moderna and Pfizer-BioNTech vaccines, as well as an advisory committee of the CDC making the recommendation.

“We know that even highly effective vaccines become less effective over time,” Dr. Murthy said. “Having reviewed the most current data, it is now our clinical judgment that the time to lay out a plan for the COVID-19 boosters is now.”

Research released Aug. 18 shows waning effectiveness of the two mRNA vaccines.

At the briefing, Dr. Murthy and others continually reassured listeners that while effectiveness against infection declines, the vaccines continue to protect against severe infections, hospitalizations, and death.

“If you are fully vaccinated, you still have a high degree of protection against the worst outcomes,” Dr. Murthy said.
 

Data driving the plan

CDC Director Rochelle Walensky, MD, cited three research studies published Aug. 18 in the CDC’s Morbidity and Mortality Weekly Report that helped to drive the decision to recommend boosters.

Analysis of nursing home COVID-19 data from the CDC’s National Healthcare Safety Network showed a significant decline in the effectiveness of the full mRNA vaccine against lab-confirmed COVID-19 infection, from 74.7% before the Delta variant (March 1-May 9, 2021) to 53% when the Delta variant became predominant in the United States. The analysis during the Delta dominant period included 85,000 weekly reports from nearly 15,000 facilities.

Another study looked at more than 10 million New York adults who had been fully vaccinated with either the Moderna, Pfizer, or J&J vaccine by July 25. During the period from May 3 to July 25, overall, the age-adjusted vaccine effectiveness against infection decreased from 91.7% to 79.8%.

Vaccine effectiveness against hospitalization remains high, another study found. An analysis of 1,129 patients who had gotten two doses of an mRNA vaccine showed vaccine effectiveness against hospitalization after 24 weeks. It was 86% at weeks 2-12 and 84% at weeks 13-24.
 

Immunologic facts

Immunologic information also points to the need for a booster, said Anthony Fauci, MD, the chief medical advisor to the president and director of the National Institute of Allergy and Infectious Diseases.

“Antibody levels decline over time,” he said, “and higher antibody levels are associated with higher efficacy of the vaccine. Higher levels of antibody may be needed to protect against Delta.”

A booster increased antibody levels by ‘’at least tenfold and possibly more,” he said. And higher levels of antibody may be required to protect against Delta. Taken together, he said, the data support the use of a booster to increase the overall level of protection.
 

 

 

Booster details

“We will make sure it is convenient and easy to get the booster shot,” said Jeff Zients, the White House COVID-19 response coordinator. As with the previous immunization, he said, the booster will be free, and no one will be asked about immigration status.

The plan for booster shots is an attempt to stay ahead of the virus, officials stressed
 

Big picture

Not everyone agrees with the booster dose idea. At a World Health Organization briefing Aug. 18, WHO’s Chief Scientist Soumya Swaminathan, MD, an Indian pediatrician, said that the right thing to do right now ‘’is to wait for the science to tell us when boosters, which groups of people, and which vaccines need boosters.”

Like others, she also broached the ‘’moral and ethical argument of giving people third doses, when they’re already well protected and while the rest of the world is waiting for their primary immunization.”

Dr. Swaminathan does see a role for boosters to protect immunocompromised people but noted that ‘’that’s a small number of people.” Widespread boosters ‘’will only lead to more variants, to more escape variants, and perhaps we’re heading into more dire situations.”



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

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Booster shots to ramp up protection against COVID-19 infection are slated to begin the week of Sept. 20, the Biden administration announced at a press briefing August 18.

Those who received the Pfizer-BioNTech and Moderna vaccines would be eligible to get a booster shot 8 months after they received the second dose of those vaccines, officials said. Information on boosters for those who got the one-dose Johnson & Johnson vaccine will be forthcoming.

“We anticipate a booster will [also] likely be needed,” said U.S. Surgeon General Vivek Murthy, MD. The J&J vaccine was not available in the U.S. until March, he said, and ‘’we expect more data on J&J in the coming weeks, so that plan is coming.”

The plan for boosters for the two mRNA vaccines is pending the FDA’s conducting of an independent review and authorizing the third dose of the Moderna and Pfizer-BioNTech vaccines, as well as an advisory committee of the CDC making the recommendation.

“We know that even highly effective vaccines become less effective over time,” Dr. Murthy said. “Having reviewed the most current data, it is now our clinical judgment that the time to lay out a plan for the COVID-19 boosters is now.”

Research released Aug. 18 shows waning effectiveness of the two mRNA vaccines.

At the briefing, Dr. Murthy and others continually reassured listeners that while effectiveness against infection declines, the vaccines continue to protect against severe infections, hospitalizations, and death.

“If you are fully vaccinated, you still have a high degree of protection against the worst outcomes,” Dr. Murthy said.
 

Data driving the plan

CDC Director Rochelle Walensky, MD, cited three research studies published Aug. 18 in the CDC’s Morbidity and Mortality Weekly Report that helped to drive the decision to recommend boosters.

Analysis of nursing home COVID-19 data from the CDC’s National Healthcare Safety Network showed a significant decline in the effectiveness of the full mRNA vaccine against lab-confirmed COVID-19 infection, from 74.7% before the Delta variant (March 1-May 9, 2021) to 53% when the Delta variant became predominant in the United States. The analysis during the Delta dominant period included 85,000 weekly reports from nearly 15,000 facilities.

Another study looked at more than 10 million New York adults who had been fully vaccinated with either the Moderna, Pfizer, or J&J vaccine by July 25. During the period from May 3 to July 25, overall, the age-adjusted vaccine effectiveness against infection decreased from 91.7% to 79.8%.

Vaccine effectiveness against hospitalization remains high, another study found. An analysis of 1,129 patients who had gotten two doses of an mRNA vaccine showed vaccine effectiveness against hospitalization after 24 weeks. It was 86% at weeks 2-12 and 84% at weeks 13-24.
 

Immunologic facts

Immunologic information also points to the need for a booster, said Anthony Fauci, MD, the chief medical advisor to the president and director of the National Institute of Allergy and Infectious Diseases.

“Antibody levels decline over time,” he said, “and higher antibody levels are associated with higher efficacy of the vaccine. Higher levels of antibody may be needed to protect against Delta.”

A booster increased antibody levels by ‘’at least tenfold and possibly more,” he said. And higher levels of antibody may be required to protect against Delta. Taken together, he said, the data support the use of a booster to increase the overall level of protection.
 

 

 

Booster details

“We will make sure it is convenient and easy to get the booster shot,” said Jeff Zients, the White House COVID-19 response coordinator. As with the previous immunization, he said, the booster will be free, and no one will be asked about immigration status.

The plan for booster shots is an attempt to stay ahead of the virus, officials stressed
 

Big picture

Not everyone agrees with the booster dose idea. At a World Health Organization briefing Aug. 18, WHO’s Chief Scientist Soumya Swaminathan, MD, an Indian pediatrician, said that the right thing to do right now ‘’is to wait for the science to tell us when boosters, which groups of people, and which vaccines need boosters.”

Like others, she also broached the ‘’moral and ethical argument of giving people third doses, when they’re already well protected and while the rest of the world is waiting for their primary immunization.”

Dr. Swaminathan does see a role for boosters to protect immunocompromised people but noted that ‘’that’s a small number of people.” Widespread boosters ‘’will only lead to more variants, to more escape variants, and perhaps we’re heading into more dire situations.”



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

Booster shots to ramp up protection against COVID-19 infection are slated to begin the week of Sept. 20, the Biden administration announced at a press briefing August 18.

Those who received the Pfizer-BioNTech and Moderna vaccines would be eligible to get a booster shot 8 months after they received the second dose of those vaccines, officials said. Information on boosters for those who got the one-dose Johnson & Johnson vaccine will be forthcoming.

“We anticipate a booster will [also] likely be needed,” said U.S. Surgeon General Vivek Murthy, MD. The J&J vaccine was not available in the U.S. until March, he said, and ‘’we expect more data on J&J in the coming weeks, so that plan is coming.”

The plan for boosters for the two mRNA vaccines is pending the FDA’s conducting of an independent review and authorizing the third dose of the Moderna and Pfizer-BioNTech vaccines, as well as an advisory committee of the CDC making the recommendation.

“We know that even highly effective vaccines become less effective over time,” Dr. Murthy said. “Having reviewed the most current data, it is now our clinical judgment that the time to lay out a plan for the COVID-19 boosters is now.”

Research released Aug. 18 shows waning effectiveness of the two mRNA vaccines.

At the briefing, Dr. Murthy and others continually reassured listeners that while effectiveness against infection declines, the vaccines continue to protect against severe infections, hospitalizations, and death.

“If you are fully vaccinated, you still have a high degree of protection against the worst outcomes,” Dr. Murthy said.
 

Data driving the plan

CDC Director Rochelle Walensky, MD, cited three research studies published Aug. 18 in the CDC’s Morbidity and Mortality Weekly Report that helped to drive the decision to recommend boosters.

Analysis of nursing home COVID-19 data from the CDC’s National Healthcare Safety Network showed a significant decline in the effectiveness of the full mRNA vaccine against lab-confirmed COVID-19 infection, from 74.7% before the Delta variant (March 1-May 9, 2021) to 53% when the Delta variant became predominant in the United States. The analysis during the Delta dominant period included 85,000 weekly reports from nearly 15,000 facilities.

Another study looked at more than 10 million New York adults who had been fully vaccinated with either the Moderna, Pfizer, or J&J vaccine by July 25. During the period from May 3 to July 25, overall, the age-adjusted vaccine effectiveness against infection decreased from 91.7% to 79.8%.

Vaccine effectiveness against hospitalization remains high, another study found. An analysis of 1,129 patients who had gotten two doses of an mRNA vaccine showed vaccine effectiveness against hospitalization after 24 weeks. It was 86% at weeks 2-12 and 84% at weeks 13-24.
 

Immunologic facts

Immunologic information also points to the need for a booster, said Anthony Fauci, MD, the chief medical advisor to the president and director of the National Institute of Allergy and Infectious Diseases.

“Antibody levels decline over time,” he said, “and higher antibody levels are associated with higher efficacy of the vaccine. Higher levels of antibody may be needed to protect against Delta.”

A booster increased antibody levels by ‘’at least tenfold and possibly more,” he said. And higher levels of antibody may be required to protect against Delta. Taken together, he said, the data support the use of a booster to increase the overall level of protection.
 

 

 

Booster details

“We will make sure it is convenient and easy to get the booster shot,” said Jeff Zients, the White House COVID-19 response coordinator. As with the previous immunization, he said, the booster will be free, and no one will be asked about immigration status.

The plan for booster shots is an attempt to stay ahead of the virus, officials stressed
 

Big picture

Not everyone agrees with the booster dose idea. At a World Health Organization briefing Aug. 18, WHO’s Chief Scientist Soumya Swaminathan, MD, an Indian pediatrician, said that the right thing to do right now ‘’is to wait for the science to tell us when boosters, which groups of people, and which vaccines need boosters.”

Like others, she also broached the ‘’moral and ethical argument of giving people third doses, when they’re already well protected and while the rest of the world is waiting for their primary immunization.”

Dr. Swaminathan does see a role for boosters to protect immunocompromised people but noted that ‘’that’s a small number of people.” Widespread boosters ‘’will only lead to more variants, to more escape variants, and perhaps we’re heading into more dire situations.”



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

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Latest data show increase in breakthrough COVID-19 cases

Article Type
Changed
Thu, 08/26/2021 - 15:43

Preliminary data from seven states suggests that breakthrough COVID-19 infections among vaccinated people may be on the rise because of the more contagious Delta variant.

Breakthrough cases accounted for about one in five newly diagnosed cases in six of the states, according to the New York Times. Hospitalizations and deaths among vaccinated people may be higher than previously thought as well.

“Remember when the early vaccine studies came out, it was like nobody gets hospitalized, nobody dies,” Robert Wachter, MD, chairman of the department of medicine at the University of California, San Francisco, said in an interview. “That clearly is not true.”

The New York Times analyzed data in seven states – California, Colorado, Massachusetts, Oregon, Utah, Vermont, and Virginia – that are tracking the most detailed information. The trends in these states may not reflect the numbers throughout the country, the newspaper reported.

Even still, the numbers back up the idea that vaccinated people may need booster shots this fall to support their earlier vaccine doses. Federal health officials are scheduled to approve the extra shots in coming weeks, potentially in September. The first people to receive booster shots will likely be health care workers and nursing home residents who took the first vaccines in December and January.

“If the chances of a breakthrough infection have gone up considerably, and I think the evidence is clear that they have, and the level of protection against severe illness is no longer as robust as it was, I think the case for boosters goes up pretty quickly,” Dr. Wachter said.

Previous analyses of breakthrough cases included data from June and earlier, the newspaper reported. But since July, COVID-19 cases have soared again because of the Delta variant, and the most recent numbers show an uptick among vaccinated people. In Los Angeles County, for instance, fully vaccinated people account for 20% of new COVID-19 cases, which is up from 11% in May, 5% in April, and 2% in March, according to a late July report from the Los Angeles County Department of Public Health.

What’s more, breakthrough infections in the seven states accounted for 12%-24% of COVID-19 hospitalizations in those states. About 8,000 breakthrough hospitalizations have been reported to the CDC. Still, the overall numbers remain low – in California, for instance, about 1,615 people have been hospitalized with breakthrough infections, which accounts for 0.007% of the state’s 22 million vaccinated people, the Times reported.

The breakthrough infections appear to be more severe among vaccinated people who are older or have weakened immune systems. About 74% of breakthrough cases are among adults 65 or older, the CDC reported.

The increase may shift how vaccinated people see their risks for infection and interact with loved ones. Public health officials have suggested that people follow some COVID-19 safety protocols again, such as wearing masks in public indoor spaces regardless of vaccination status.

As the Delta variant continues to circulate this fall, public health researchers will be researching more about breakthrough cases among vaccinated people, including whether they have prolonged symptoms and how easily they may pass the virus to others.

“I think some of us have been challenged by the numbers of clusters that we’ve seen,” Michael Osterholm, PhD, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, told this news organization.

“I think that really needs to be examined more,” he said.

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

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Preliminary data from seven states suggests that breakthrough COVID-19 infections among vaccinated people may be on the rise because of the more contagious Delta variant.

Breakthrough cases accounted for about one in five newly diagnosed cases in six of the states, according to the New York Times. Hospitalizations and deaths among vaccinated people may be higher than previously thought as well.

“Remember when the early vaccine studies came out, it was like nobody gets hospitalized, nobody dies,” Robert Wachter, MD, chairman of the department of medicine at the University of California, San Francisco, said in an interview. “That clearly is not true.”

The New York Times analyzed data in seven states – California, Colorado, Massachusetts, Oregon, Utah, Vermont, and Virginia – that are tracking the most detailed information. The trends in these states may not reflect the numbers throughout the country, the newspaper reported.

Even still, the numbers back up the idea that vaccinated people may need booster shots this fall to support their earlier vaccine doses. Federal health officials are scheduled to approve the extra shots in coming weeks, potentially in September. The first people to receive booster shots will likely be health care workers and nursing home residents who took the first vaccines in December and January.

“If the chances of a breakthrough infection have gone up considerably, and I think the evidence is clear that they have, and the level of protection against severe illness is no longer as robust as it was, I think the case for boosters goes up pretty quickly,” Dr. Wachter said.

Previous analyses of breakthrough cases included data from June and earlier, the newspaper reported. But since July, COVID-19 cases have soared again because of the Delta variant, and the most recent numbers show an uptick among vaccinated people. In Los Angeles County, for instance, fully vaccinated people account for 20% of new COVID-19 cases, which is up from 11% in May, 5% in April, and 2% in March, according to a late July report from the Los Angeles County Department of Public Health.

What’s more, breakthrough infections in the seven states accounted for 12%-24% of COVID-19 hospitalizations in those states. About 8,000 breakthrough hospitalizations have been reported to the CDC. Still, the overall numbers remain low – in California, for instance, about 1,615 people have been hospitalized with breakthrough infections, which accounts for 0.007% of the state’s 22 million vaccinated people, the Times reported.

The breakthrough infections appear to be more severe among vaccinated people who are older or have weakened immune systems. About 74% of breakthrough cases are among adults 65 or older, the CDC reported.

The increase may shift how vaccinated people see their risks for infection and interact with loved ones. Public health officials have suggested that people follow some COVID-19 safety protocols again, such as wearing masks in public indoor spaces regardless of vaccination status.

As the Delta variant continues to circulate this fall, public health researchers will be researching more about breakthrough cases among vaccinated people, including whether they have prolonged symptoms and how easily they may pass the virus to others.

“I think some of us have been challenged by the numbers of clusters that we’ve seen,” Michael Osterholm, PhD, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, told this news organization.

“I think that really needs to be examined more,” he said.

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

Preliminary data from seven states suggests that breakthrough COVID-19 infections among vaccinated people may be on the rise because of the more contagious Delta variant.

Breakthrough cases accounted for about one in five newly diagnosed cases in six of the states, according to the New York Times. Hospitalizations and deaths among vaccinated people may be higher than previously thought as well.

“Remember when the early vaccine studies came out, it was like nobody gets hospitalized, nobody dies,” Robert Wachter, MD, chairman of the department of medicine at the University of California, San Francisco, said in an interview. “That clearly is not true.”

The New York Times analyzed data in seven states – California, Colorado, Massachusetts, Oregon, Utah, Vermont, and Virginia – that are tracking the most detailed information. The trends in these states may not reflect the numbers throughout the country, the newspaper reported.

Even still, the numbers back up the idea that vaccinated people may need booster shots this fall to support their earlier vaccine doses. Federal health officials are scheduled to approve the extra shots in coming weeks, potentially in September. The first people to receive booster shots will likely be health care workers and nursing home residents who took the first vaccines in December and January.

“If the chances of a breakthrough infection have gone up considerably, and I think the evidence is clear that they have, and the level of protection against severe illness is no longer as robust as it was, I think the case for boosters goes up pretty quickly,” Dr. Wachter said.

Previous analyses of breakthrough cases included data from June and earlier, the newspaper reported. But since July, COVID-19 cases have soared again because of the Delta variant, and the most recent numbers show an uptick among vaccinated people. In Los Angeles County, for instance, fully vaccinated people account for 20% of new COVID-19 cases, which is up from 11% in May, 5% in April, and 2% in March, according to a late July report from the Los Angeles County Department of Public Health.

What’s more, breakthrough infections in the seven states accounted for 12%-24% of COVID-19 hospitalizations in those states. About 8,000 breakthrough hospitalizations have been reported to the CDC. Still, the overall numbers remain low – in California, for instance, about 1,615 people have been hospitalized with breakthrough infections, which accounts for 0.007% of the state’s 22 million vaccinated people, the Times reported.

The breakthrough infections appear to be more severe among vaccinated people who are older or have weakened immune systems. About 74% of breakthrough cases are among adults 65 or older, the CDC reported.

The increase may shift how vaccinated people see their risks for infection and interact with loved ones. Public health officials have suggested that people follow some COVID-19 safety protocols again, such as wearing masks in public indoor spaces regardless of vaccination status.

As the Delta variant continues to circulate this fall, public health researchers will be researching more about breakthrough cases among vaccinated people, including whether they have prolonged symptoms and how easily they may pass the virus to others.

“I think some of us have been challenged by the numbers of clusters that we’ve seen,” Michael Osterholm, PhD, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, told this news organization.

“I think that really needs to be examined more,” he said.

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

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