Pediatric News

It’s a true Goldilocks debate: A week after the Centers for Disease Control and Prevention updated its COVID-19 isolation and quarantine guidelines – lowering isolation time – health care experts continued to debate the changes, with some calling them suitable, some saying they’re “reckless,” and at least one expert saying they’re “right in the middle.”

The controversy may lead to more updates. On Jan. 2, Anthony S. Fauci, MD, President Joe Biden’s chief medical adviser, said on CNN’s State of the Union that he anticipates further clarification of the guidelines soon.

Sparking the most debate: Infected people are not told to test before leaving isolation, the vaccinated and unvaccinated who are exposed are given some of the same advice, and the mask advice is not specific enough.

As issued on Dec. 27, the guidelines for the general public recommend:

• Anyone who tests positive should stay home and isolate for 5 days (instead of 10) and if the person has no symptoms or the symptoms resolve after 5 days, leaving the house is okay. A mask should be worn around others for 5 more days. In the event of a fever, the person must stay home until it resolves.
• If people are exposed to someone infected with COVID-19 and they have been boosted, finished the primary series of either the Pfizer or Moderna vaccine within the past 6 months, or finished the primary series of the Johnson & Johnson vaccine within the past 2 months, they should wear a mask around others for 10 days and, if possible, test on day 5. However, if symptoms develop, they should get a test and stay home.
• If people are exposed to someone infected with COVID-19 and they are unvaccinated or are more than 6 months out from their second dose of the Pfizer or Moderna vaccine (or more than 2 months after the J&J vaccine) and not boosted, they should quarantine for 5 days and then wear a mask for 5 more days. If quarantine is impossible, a mask should be worn for 10 days. A test on day 5 is suggested if possible. If symptoms occur, they should quarantine and test.

On social media and in interviews with this news organization, public health experts expressed an array of opinions.

A tweet from Eric Topol, MD, editor-in-chief of Medscape, posted the day after the new guidelines came out, had an empty box and this: “The data that support the new @CDCgov 5 day isolation period without a negative test.”

In a tweet on Jan. 2, Ashish K. Jha, MD, MPH, dean of the Brown University School of Public Health, said: “Hearing that CDC considering adding testing to isolation guidelines. That would be great. I’ve been arguing for a while that serial negative antigen tests provide a lot of confidence that someone is not contagious.”

Michael Mina, MD, PhD, chief science officer of eMed, a digital point-of-care platform enabling at-home diagnostic testing, tweeted: “CDC’s new guidance to drop isolation of positives to 5 days without a negative test is reckless. Some [people] stay infectious 3 days, some 12. I absolutely don’t want to sit next to someone who turned [positive] 5 days ago and hasn’t tested Neg. Test Neg to leave isolation early is just smart.”

Paul Offit, MD, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia and an infectious disease specialist, disagrees. Typically, he said, an infected person sheds virus for 7 days. 

“If you are asymptomatic, the chances that you are shedding a significant amount of virus is very, very small,” he said in an interview.
 

Under debate

Testing: While many public health experts say a recommendation to test before leaving isolation is needed, CDC Director Rochelle Walensky, MD, explained testing was not recommended before leaving isolation because PCR testing can stay positive up to 12 weeks after a person is first infected with COVID-19.

Asked why there was not a recommendation for a rapid antigen test before leaving isolation, Dr. Walensky told CNN that it is not known how these tests perform at the end of infection and that the tests are not Food and Drug Administration–authorized for that purpose.

And while the guidelines suggest that those exposed – whether they are boosted, vaccinated, or not – should test on day 5 if possible, that recommendation should be stronger, some said. “At the very least recommend a test in those who can get it done,” said Dr. Topol.

However, making that recommendation is difficult when experts know how difficult it is for people to obtain tests now, William Schaffner, MD, professor of preventive medicine and an infectious disease specialist at Vanderbilt University, Nashville, Tenn., said in an interview.

“I am sure this was intensely debated,” Dr. Schaffner said of the recommendation on testing.

Vaccination status categories: Amesh Adalja, MD, senior scholar at the Johns Hopkins Center for Health Security, Baltimore, questioned the scientific basis behind treating the fully vaccinated (with two mRNA or one J&J vaccine) who are exposed ‘’as the equivalent of the unvaccinated when it comes to the quarantine requirement since the fully vaccinated are protected against what matters.”

Dr. Topol agreed: Guidelines “should be different for vaccinated versus unvaccinated.”

The recommendations for the exposed should definitely be simpler, Dr. Offit said. “I think it would be much simpler to just say, ‘If you are exposed, mask for 10 days,’ “ regardless of vaccination status.

Masks: The guidelines should also be more specific about the type of masks, Dr. Topol said. They should spell out that the masks need to be N95 or KN95, he said.

Science-driven or economy-driven? Was the guidance changed due more to concerns about the economy than to scientific information about infection and transmission? “It was,” Dr. Topol said.

Dr. Adalja sees it differently. “While it is true that this updated guidance will help the economy, it is based on a scientific foundation and should have been issued much earlier than it was.”
 

Tough decisions

The agency is walking a tightrope, Dr. Schaffner said, adding that he is in general agreement with what the CDC is trying to do. “The tightrope is between the public health ideal and trying to determine what will be acceptable,’’ he said.

The revised guidelines are more practical than before, others said. “The goal is harm reduction and many people just don’t do any isolation if they are faced with a 10-day period,” Dr. Adalja said.

Before issuing the new guidance, the CDC looked at the accumulating science and also took into account stresses on the health care system and other factors, Dr. Schaffner said. “Is it perfect?” Dr. Schaffner said of the new guideline. “No. Is it carefree? No. It’s right in the middle.”

Dr. Schaffner does think the messages about the new recommendations and how they were decided upon could have been communicated better, and in a more understandable manner. Some experts, for instance, led with the economy and the need for people to return to work and school when explaining the guidelines and then brought up the science behind the revisions.

That order should have been reversed, Dr. Schaffner said.

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

It’s a true Goldilocks debate: A week after the Centers for Disease Control and Prevention updated its COVID-19 isolation and quarantine guidelines – lowering isolation time – health care experts continued to debate the changes, with some calling them suitable, some saying they’re “reckless,” and at least one expert saying they’re “right in the middle.”

The controversy may lead to more updates. On Jan. 2, Anthony S. Fauci, MD, President Joe Biden’s chief medical adviser, said on CNN’s State of the Union that he anticipates further clarification of the guidelines soon.

Sparking the most debate: Infected people are not told to test before leaving isolation, the vaccinated and unvaccinated who are exposed are given some of the same advice, and the mask advice is not specific enough.

As issued on Dec. 27, the guidelines for the general public recommend:

• Anyone who tests positive should stay home and isolate for 5 days (instead of 10) and if the person has no symptoms or the symptoms resolve after 5 days, leaving the house is okay. A mask should be worn around others for 5 more days. In the event of a fever, the person must stay home until it resolves.
• If people are exposed to someone infected with COVID-19 and they have been boosted, finished the primary series of either the Pfizer or Moderna vaccine within the past 6 months, or finished the primary series of the Johnson & Johnson vaccine within the past 2 months, they should wear a mask around others for 10 days and, if possible, test on day 5. However, if symptoms develop, they should get a test and stay home.
• If people are exposed to someone infected with COVID-19 and they are unvaccinated or are more than 6 months out from their second dose of the Pfizer or Moderna vaccine (or more than 2 months after the J&J vaccine) and not boosted, they should quarantine for 5 days and then wear a mask for 5 more days. If quarantine is impossible, a mask should be worn for 10 days. A test on day 5 is suggested if possible. If symptoms occur, they should quarantine and test.

On social media and in interviews with this news organization, public health experts expressed an array of opinions.

A tweet from Eric Topol, MD, editor-in-chief of Medscape, posted the day after the new guidelines came out, had an empty box and this: “The data that support the new @CDCgov 5 day isolation period without a negative test.”

In a tweet on Jan. 2, Ashish K. Jha, MD, MPH, dean of the Brown University School of Public Health, said: “Hearing that CDC considering adding testing to isolation guidelines. That would be great. I’ve been arguing for a while that serial negative antigen tests provide a lot of confidence that someone is not contagious.”

Michael Mina, MD, PhD, chief science officer of eMed, a digital point-of-care platform enabling at-home diagnostic testing, tweeted: “CDC’s new guidance to drop isolation of positives to 5 days without a negative test is reckless. Some [people] stay infectious 3 days, some 12. I absolutely don’t want to sit next to someone who turned [positive] 5 days ago and hasn’t tested Neg. Test Neg to leave isolation early is just smart.”

Paul Offit, MD, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia and an infectious disease specialist, disagrees. Typically, he said, an infected person sheds virus for 7 days. 

“If you are asymptomatic, the chances that you are shedding a significant amount of virus is very, very small,” he said in an interview.
 

Under debate

Testing: While many public health experts say a recommendation to test before leaving isolation is needed, CDC Director Rochelle Walensky, MD, explained testing was not recommended before leaving isolation because PCR testing can stay positive up to 12 weeks after a person is first infected with COVID-19.

Asked why there was not a recommendation for a rapid antigen test before leaving isolation, Dr. Walensky told CNN that it is not known how these tests perform at the end of infection and that the tests are not Food and Drug Administration–authorized for that purpose.

And while the guidelines suggest that those exposed – whether they are boosted, vaccinated, or not – should test on day 5 if possible, that recommendation should be stronger, some said. “At the very least recommend a test in those who can get it done,” said Dr. Topol.

However, making that recommendation is difficult when experts know how difficult it is for people to obtain tests now, William Schaffner, MD, professor of preventive medicine and an infectious disease specialist at Vanderbilt University, Nashville, Tenn., said in an interview.

“I am sure this was intensely debated,” Dr. Schaffner said of the recommendation on testing.

Vaccination status categories: Amesh Adalja, MD, senior scholar at the Johns Hopkins Center for Health Security, Baltimore, questioned the scientific basis behind treating the fully vaccinated (with two mRNA or one J&J vaccine) who are exposed ‘’as the equivalent of the unvaccinated when it comes to the quarantine requirement since the fully vaccinated are protected against what matters.”

Dr. Topol agreed: Guidelines “should be different for vaccinated versus unvaccinated.”

The recommendations for the exposed should definitely be simpler, Dr. Offit said. “I think it would be much simpler to just say, ‘If you are exposed, mask for 10 days,’ “ regardless of vaccination status.

Masks: The guidelines should also be more specific about the type of masks, Dr. Topol said. They should spell out that the masks need to be N95 or KN95, he said.

Science-driven or economy-driven? Was the guidance changed due more to concerns about the economy than to scientific information about infection and transmission? “It was,” Dr. Topol said.

Dr. Adalja sees it differently. “While it is true that this updated guidance will help the economy, it is based on a scientific foundation and should have been issued much earlier than it was.”
 

Tough decisions

The agency is walking a tightrope, Dr. Schaffner said, adding that he is in general agreement with what the CDC is trying to do. “The tightrope is between the public health ideal and trying to determine what will be acceptable,’’ he said.

The revised guidelines are more practical than before, others said. “The goal is harm reduction and many people just don’t do any isolation if they are faced with a 10-day period,” Dr. Adalja said.

Before issuing the new guidance, the CDC looked at the accumulating science and also took into account stresses on the health care system and other factors, Dr. Schaffner said. “Is it perfect?” Dr. Schaffner said of the new guideline. “No. Is it carefree? No. It’s right in the middle.”

Dr. Schaffner does think the messages about the new recommendations and how they were decided upon could have been communicated better, and in a more understandable manner. Some experts, for instance, led with the economy and the need for people to return to work and school when explaining the guidelines and then brought up the science behind the revisions.

That order should have been reversed, Dr. Schaffner said.

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

It’s a true Goldilocks debate: A week after the Centers for Disease Control and Prevention updated its COVID-19 isolation and quarantine guidelines – lowering isolation time – health care experts continued to debate the changes, with some calling them suitable, some saying they’re “reckless,” and at least one expert saying they’re “right in the middle.”

The controversy may lead to more updates. On Jan. 2, Anthony S. Fauci, MD, President Joe Biden’s chief medical adviser, said on CNN’s State of the Union that he anticipates further clarification of the guidelines soon.

Sparking the most debate: Infected people are not told to test before leaving isolation, the vaccinated and unvaccinated who are exposed are given some of the same advice, and the mask advice is not specific enough.

As issued on Dec. 27, the guidelines for the general public recommend:

• Anyone who tests positive should stay home and isolate for 5 days (instead of 10) and if the person has no symptoms or the symptoms resolve after 5 days, leaving the house is okay. A mask should be worn around others for 5 more days. In the event of a fever, the person must stay home until it resolves.
• If people are exposed to someone infected with COVID-19 and they have been boosted, finished the primary series of either the Pfizer or Moderna vaccine within the past 6 months, or finished the primary series of the Johnson & Johnson vaccine within the past 2 months, they should wear a mask around others for 10 days and, if possible, test on day 5. However, if symptoms develop, they should get a test and stay home.
• If people are exposed to someone infected with COVID-19 and they are unvaccinated or are more than 6 months out from their second dose of the Pfizer or Moderna vaccine (or more than 2 months after the J&J vaccine) and not boosted, they should quarantine for 5 days and then wear a mask for 5 more days. If quarantine is impossible, a mask should be worn for 10 days. A test on day 5 is suggested if possible. If symptoms occur, they should quarantine and test.

On social media and in interviews with this news organization, public health experts expressed an array of opinions.

A tweet from Eric Topol, MD, editor-in-chief of Medscape, posted the day after the new guidelines came out, had an empty box and this: “The data that support the new @CDCgov 5 day isolation period without a negative test.”

In a tweet on Jan. 2, Ashish K. Jha, MD, MPH, dean of the Brown University School of Public Health, said: “Hearing that CDC considering adding testing to isolation guidelines. That would be great. I’ve been arguing for a while that serial negative antigen tests provide a lot of confidence that someone is not contagious.”

Michael Mina, MD, PhD, chief science officer of eMed, a digital point-of-care platform enabling at-home diagnostic testing, tweeted: “CDC’s new guidance to drop isolation of positives to 5 days without a negative test is reckless. Some [people] stay infectious 3 days, some 12. I absolutely don’t want to sit next to someone who turned [positive] 5 days ago and hasn’t tested Neg. Test Neg to leave isolation early is just smart.”

Paul Offit, MD, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia and an infectious disease specialist, disagrees. Typically, he said, an infected person sheds virus for 7 days. 

“If you are asymptomatic, the chances that you are shedding a significant amount of virus is very, very small,” he said in an interview.
 

Under debate

Testing: While many public health experts say a recommendation to test before leaving isolation is needed, CDC Director Rochelle Walensky, MD, explained testing was not recommended before leaving isolation because PCR testing can stay positive up to 12 weeks after a person is first infected with COVID-19.

Asked why there was not a recommendation for a rapid antigen test before leaving isolation, Dr. Walensky told CNN that it is not known how these tests perform at the end of infection and that the tests are not Food and Drug Administration–authorized for that purpose.

And while the guidelines suggest that those exposed – whether they are boosted, vaccinated, or not – should test on day 5 if possible, that recommendation should be stronger, some said. “At the very least recommend a test in those who can get it done,” said Dr. Topol.

However, making that recommendation is difficult when experts know how difficult it is for people to obtain tests now, William Schaffner, MD, professor of preventive medicine and an infectious disease specialist at Vanderbilt University, Nashville, Tenn., said in an interview.

“I am sure this was intensely debated,” Dr. Schaffner said of the recommendation on testing.

Vaccination status categories: Amesh Adalja, MD, senior scholar at the Johns Hopkins Center for Health Security, Baltimore, questioned the scientific basis behind treating the fully vaccinated (with two mRNA or one J&J vaccine) who are exposed ‘’as the equivalent of the unvaccinated when it comes to the quarantine requirement since the fully vaccinated are protected against what matters.”

Dr. Topol agreed: Guidelines “should be different for vaccinated versus unvaccinated.”

The recommendations for the exposed should definitely be simpler, Dr. Offit said. “I think it would be much simpler to just say, ‘If you are exposed, mask for 10 days,’ “ regardless of vaccination status.

Masks: The guidelines should also be more specific about the type of masks, Dr. Topol said. They should spell out that the masks need to be N95 or KN95, he said.

Science-driven or economy-driven? Was the guidance changed due more to concerns about the economy than to scientific information about infection and transmission? “It was,” Dr. Topol said.

Dr. Adalja sees it differently. “While it is true that this updated guidance will help the economy, it is based on a scientific foundation and should have been issued much earlier than it was.”
 

Tough decisions

The agency is walking a tightrope, Dr. Schaffner said, adding that he is in general agreement with what the CDC is trying to do. “The tightrope is between the public health ideal and trying to determine what will be acceptable,’’ he said.

The revised guidelines are more practical than before, others said. “The goal is harm reduction and many people just don’t do any isolation if they are faced with a 10-day period,” Dr. Adalja said.

Before issuing the new guidance, the CDC looked at the accumulating science and also took into account stresses on the health care system and other factors, Dr. Schaffner said. “Is it perfect?” Dr. Schaffner said of the new guideline. “No. Is it carefree? No. It’s right in the middle.”

Dr. Schaffner does think the messages about the new recommendations and how they were decided upon could have been communicated better, and in a more understandable manner. Some experts, for instance, led with the economy and the need for people to return to work and school when explaining the guidelines and then brought up the science behind the revisions.

That order should have been reversed, Dr. Schaffner said.

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

Maria Trent, MD, MPH, was studying ways clinicians can leverage technology to care for adolescents years before COVID-19 exposed the challenges and advantages of telehealth.

Dr. Trent, a pediatrician and adolescent medicine specialist and professor of pediatrics at Johns Hopkins University, Baltimore, has long believed that the phones in her patients’ pockets have the potential to improve the sexual health of youth. The pandemic has only made that view stronger.

“They’re a generation that’s really wired and online,” Dr. Trent told this news organization. “I think that we can meet them in that space.”

Her research has incorporated texting, apps, and videos. Out of necessity, technology increasingly became part of patient care during the pandemic. “We had to stretch our ability to do some basic triage and assessments of patients online,” Dr. Trent said.

Even when clinics are closed, doctors might be able to provide initial care remotely, such as writing prescriptions to manage symptoms or directing patients to a lab for testing.

Telemedicine could allow a clinician to guide a teenager who thinks they might be pregnant to take a store-bought test and avoid possible exposure to COVID-19 in the ED, for instance.

But doctors have concerns about the legal and practical limits of privacy and confidentiality. Who else is at home listening to a phone conversation? Are parents accessing the patient’s online portal? Will parents receive an explanation of benefits that lists testing for a sexually transmitted infection, or see a testing kit that is delivered to their home?

When a young patient needs in-person care, transportation can be a barrier. And then there’s the matter of clinicians being able to bill for telehealth services.

Practices are learning how to navigate these issues, and relevant laws vary by state.

“I think this is going to become part of standard practice,” Dr. Trent said. “I think we have to do the hard work to make sure that it’s safe, that it’s accessible, and that it is actually improving care.”
 

Texts, apps, videos

In one early study, Dr. Trent and colleagues found that showing adolescents with pelvic inflammatory disease a 6-minute video may improve treatment rates for their sexual partners.

Another study provided preliminary evidence that text messaging support might improve clinic attendance for moderately long-acting reversible contraception.

A third trial showed that adolescents and young adults with pelvic inflammatory disease who were randomly assigned to receive text-message prompts to take their medications and provide information about the doses they consumed had greater decreases in Neisseria gonorrhoeae and Chlamydia trachomatis infections, compared with patients who received standard care.

Dr. Trent and coinvestigators are assessing a technology-based intervention for youth with HIV, in which patients can use an app to submit videos of themselves taking antiretroviral therapy and report any side effects. The technology provides a way to monitor patients remotely and support them between visits, she said.
 

Will pandemic-driven options remain?

In 2020, Laura D. Lindberg, PhD, principal research scientist at the Guttmacher Institute in New York, and coauthors discussed the possible ramifications of the pandemic on the sexual and reproductive health of adolescents and young adults.

If telemedicine options driven by COVID-19 are here to stay, adolescents and young adults could be “the age group most likely to continue that approach rather than returning to traditional in-person visits,” the researchers wrote. “Innovations in health care service provision, such as use of telemedicine and obtaining contraceptives and STI testing by mail, will help expand access to [sexual and reproductive health] care for young people.”

At the 2021 annual conference of the American Academy of Pediatrics, Dr. Trent described telehealth as a viable way to provide sexual and reproductive health care to adolescents and young adults, including anticipatory guidance, contraception counseling, coordination of follow-up care and testing, and connecting patients to resources.

Her presentation cited several websites that can help patients receive testing for STIs, including Yes Means Test, the Centers for Disease Control and Prevention’s GetTested page, and I Want the Kit. Planned Parenthood has telehealth options, and the Kaiser Family Foundation compiled information about 26 online platforms that were providing contraception or STI services.
 

Who else is in the room?

“There’s only so much time in the day and so many patients you can see, regardless of whether you have telehealth or not,” said David L. Bell, MD, MPH, president of the Society for Adolescent Health and Medicine and a coauthor of the Perspectives on Sexual and Reproductive Health paper. In addition, “you never know who else is in the room” with the patient on the other end, added Dr. Bell, a professor of population and family health and pediatrics at the Columbia University Medical Center and medical director of the Young Men’s Clinic, both in New York.

In some respects, young patients may not be able to participate in telehealth visits the same way they would in a medical office, Dr. Trent acknowledged. Encouraging the use of headphones is one way to help protect confidentiality when talking with patients who are at home and might not be alone.

But if patients are able to find a private space for remote visits, they might be more open than usual. In that way, telemedicine could provide additional opportunities to address issues like substance use disorders and mental health, as well, she said.

“Then, if they need something, we have to problem solve,” Dr. Trent said. Next steps may involve engaging a parent or getting the patient to a lab or the clinic.
 

Sex ed may be lacking

The Perspectives article also raised concerns that the pandemic might exacerbate shortcomings in sex education, which already may have been lacking.

“Before the pandemic, schools were a key source of formal sex education for young people,” the authors wrote. “Sex education, which was already limited in many areas of the country, has likely not been included in the national shift to online learning. Even when in-person schooling resumes, missed sex education instruction is unlikely to be made up, given the modest attention it received prior to the pandemic.”

A recently published study in the Journal of Adolescent Health indicates that American teenagers currently receive less formal sex education than they did 25 years ago, with “troubling” inequities by race.

Researchers surveyed adolescents about what they had learned about topics such as how to say no to sex, methods of birth control and where to get them, and STIs.

Dr. Lindberg and Leslie M. Kantor, PhD, MPH, professor and chair of the department of urban-global public health at Rutgers University, Newark, N.J., conducted the analysis.

“Pediatricians and other health care providers that work with children and adolescents have a critical role to play in providing information about sexuality to both the patients and to the parents,” said Dr. Kantor, who also coauthored the Perspectives article with Dr. Lindberg and Dr. Bell. The new research “shows that doctors play an even more critical role, because they can’t assume that their patients are going to get the information that they need in a timely way from schools.”

By age 15, 21% of girls and 20% of boys have had sexual intercourse at least once, according to data from the 2015-2017 National Survey of Family Growth. By age 17, the percentages were 53% of girls and 48% of boys. By age 20, the percentages were 79% of women and 77% of men. The CDC’s 2021 guidelines on treatment and screening for STIs note that prevalence rates of certain infections – such as chlamydia and gonorrhea in females – are highest among adolescents and young adults.

Those trends underscore the importance of counseling on sexual health that clinicians can provide, but time constraints may limit how much they can discuss in a single session with a patient. To cover all topics that are important to parents and patients, doctors may need to discuss sexual and reproductive health sooner and more frequently.

Young people are getting more and more explicit information from their phones and media, yet educators are giving them less information to navigate these topics and learn what’s real, Dr. Kantor said. That mismatch can be toxic. In a December 2021 interview with Howard Stern, the pop star Billie Eilish said she started watching pornography at about age 11 and frequently watched videos that were violent. “I think it really destroyed my brain and I feel incredibly devastated that I was exposed to so much porn,” Ms. Eilish told Mr. Stern.

Researchers and a psychologist told CNN that the singer’s story may be typical. It also highlights a need to be aware of kids’ online activities and to have conversations about how pornography may not depict healthy interactions, they said.

Beyond discussing a plan for preventing pregnancy and STIs, Dr. Kantor encouraged discussions about what constitutes healthy relationships, as well as check-ins about intimate partner violence and how romantic relationships are going.

“I think for pediatricians and for parents, it’s a muscle,” she said. “As you bring up these topics more, listen, and respond, you get more comfortable with it.”

Dr. Trent has served as an advisory board member on a sexual health council for Trojan (Church & Dwight Company) and has received research funding from Hologic and research supplies from SpeeDx. Dr. Bell has received funds from the Merck Foundation, Merck, and Gilead. Dr. Kantor had no disclosures.

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

Maria Trent, MD, MPH, was studying ways clinicians can leverage technology to care for adolescents years before COVID-19 exposed the challenges and advantages of telehealth.

Dr. Trent, a pediatrician and adolescent medicine specialist and professor of pediatrics at Johns Hopkins University, Baltimore, has long believed that the phones in her patients’ pockets have the potential to improve the sexual health of youth. The pandemic has only made that view stronger.

“They’re a generation that’s really wired and online,” Dr. Trent told this news organization. “I think that we can meet them in that space.”

Her research has incorporated texting, apps, and videos. Out of necessity, technology increasingly became part of patient care during the pandemic. “We had to stretch our ability to do some basic triage and assessments of patients online,” Dr. Trent said.

Even when clinics are closed, doctors might be able to provide initial care remotely, such as writing prescriptions to manage symptoms or directing patients to a lab for testing.

Telemedicine could allow a clinician to guide a teenager who thinks they might be pregnant to take a store-bought test and avoid possible exposure to COVID-19 in the ED, for instance.

But doctors have concerns about the legal and practical limits of privacy and confidentiality. Who else is at home listening to a phone conversation? Are parents accessing the patient’s online portal? Will parents receive an explanation of benefits that lists testing for a sexually transmitted infection, or see a testing kit that is delivered to their home?

When a young patient needs in-person care, transportation can be a barrier. And then there’s the matter of clinicians being able to bill for telehealth services.

Practices are learning how to navigate these issues, and relevant laws vary by state.

“I think this is going to become part of standard practice,” Dr. Trent said. “I think we have to do the hard work to make sure that it’s safe, that it’s accessible, and that it is actually improving care.”
 

Texts, apps, videos

In one early study, Dr. Trent and colleagues found that showing adolescents with pelvic inflammatory disease a 6-minute video may improve treatment rates for their sexual partners.

Another study provided preliminary evidence that text messaging support might improve clinic attendance for moderately long-acting reversible contraception.

A third trial showed that adolescents and young adults with pelvic inflammatory disease who were randomly assigned to receive text-message prompts to take their medications and provide information about the doses they consumed had greater decreases in Neisseria gonorrhoeae and Chlamydia trachomatis infections, compared with patients who received standard care.

Dr. Trent and coinvestigators are assessing a technology-based intervention for youth with HIV, in which patients can use an app to submit videos of themselves taking antiretroviral therapy and report any side effects. The technology provides a way to monitor patients remotely and support them between visits, she said.
 

Will pandemic-driven options remain?

In 2020, Laura D. Lindberg, PhD, principal research scientist at the Guttmacher Institute in New York, and coauthors discussed the possible ramifications of the pandemic on the sexual and reproductive health of adolescents and young adults.

If telemedicine options driven by COVID-19 are here to stay, adolescents and young adults could be “the age group most likely to continue that approach rather than returning to traditional in-person visits,” the researchers wrote. “Innovations in health care service provision, such as use of telemedicine and obtaining contraceptives and STI testing by mail, will help expand access to [sexual and reproductive health] care for young people.”

At the 2021 annual conference of the American Academy of Pediatrics, Dr. Trent described telehealth as a viable way to provide sexual and reproductive health care to adolescents and young adults, including anticipatory guidance, contraception counseling, coordination of follow-up care and testing, and connecting patients to resources.

Her presentation cited several websites that can help patients receive testing for STIs, including Yes Means Test, the Centers for Disease Control and Prevention’s GetTested page, and I Want the Kit. Planned Parenthood has telehealth options, and the Kaiser Family Foundation compiled information about 26 online platforms that were providing contraception or STI services.
 

Who else is in the room?

“There’s only so much time in the day and so many patients you can see, regardless of whether you have telehealth or not,” said David L. Bell, MD, MPH, president of the Society for Adolescent Health and Medicine and a coauthor of the Perspectives on Sexual and Reproductive Health paper. In addition, “you never know who else is in the room” with the patient on the other end, added Dr. Bell, a professor of population and family health and pediatrics at the Columbia University Medical Center and medical director of the Young Men’s Clinic, both in New York.

In some respects, young patients may not be able to participate in telehealth visits the same way they would in a medical office, Dr. Trent acknowledged. Encouraging the use of headphones is one way to help protect confidentiality when talking with patients who are at home and might not be alone.

But if patients are able to find a private space for remote visits, they might be more open than usual. In that way, telemedicine could provide additional opportunities to address issues like substance use disorders and mental health, as well, she said.

“Then, if they need something, we have to problem solve,” Dr. Trent said. Next steps may involve engaging a parent or getting the patient to a lab or the clinic.
 

Sex ed may be lacking

The Perspectives article also raised concerns that the pandemic might exacerbate shortcomings in sex education, which already may have been lacking.

“Before the pandemic, schools were a key source of formal sex education for young people,” the authors wrote. “Sex education, which was already limited in many areas of the country, has likely not been included in the national shift to online learning. Even when in-person schooling resumes, missed sex education instruction is unlikely to be made up, given the modest attention it received prior to the pandemic.”

A recently published study in the Journal of Adolescent Health indicates that American teenagers currently receive less formal sex education than they did 25 years ago, with “troubling” inequities by race.

Researchers surveyed adolescents about what they had learned about topics such as how to say no to sex, methods of birth control and where to get them, and STIs.

Dr. Lindberg and Leslie M. Kantor, PhD, MPH, professor and chair of the department of urban-global public health at Rutgers University, Newark, N.J., conducted the analysis.

“Pediatricians and other health care providers that work with children and adolescents have a critical role to play in providing information about sexuality to both the patients and to the parents,” said Dr. Kantor, who also coauthored the Perspectives article with Dr. Lindberg and Dr. Bell. The new research “shows that doctors play an even more critical role, because they can’t assume that their patients are going to get the information that they need in a timely way from schools.”

By age 15, 21% of girls and 20% of boys have had sexual intercourse at least once, according to data from the 2015-2017 National Survey of Family Growth. By age 17, the percentages were 53% of girls and 48% of boys. By age 20, the percentages were 79% of women and 77% of men. The CDC’s 2021 guidelines on treatment and screening for STIs note that prevalence rates of certain infections – such as chlamydia and gonorrhea in females – are highest among adolescents and young adults.

Those trends underscore the importance of counseling on sexual health that clinicians can provide, but time constraints may limit how much they can discuss in a single session with a patient. To cover all topics that are important to parents and patients, doctors may need to discuss sexual and reproductive health sooner and more frequently.

Young people are getting more and more explicit information from their phones and media, yet educators are giving them less information to navigate these topics and learn what’s real, Dr. Kantor said. That mismatch can be toxic. In a December 2021 interview with Howard Stern, the pop star Billie Eilish said she started watching pornography at about age 11 and frequently watched videos that were violent. “I think it really destroyed my brain and I feel incredibly devastated that I was exposed to so much porn,” Ms. Eilish told Mr. Stern.

Researchers and a psychologist told CNN that the singer’s story may be typical. It also highlights a need to be aware of kids’ online activities and to have conversations about how pornography may not depict healthy interactions, they said.

Beyond discussing a plan for preventing pregnancy and STIs, Dr. Kantor encouraged discussions about what constitutes healthy relationships, as well as check-ins about intimate partner violence and how romantic relationships are going.

“I think for pediatricians and for parents, it’s a muscle,” she said. “As you bring up these topics more, listen, and respond, you get more comfortable with it.”

Dr. Trent has served as an advisory board member on a sexual health council for Trojan (Church & Dwight Company) and has received research funding from Hologic and research supplies from SpeeDx. Dr. Bell has received funds from the Merck Foundation, Merck, and Gilead. Dr. Kantor had no disclosures.

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

Maria Trent, MD, MPH, was studying ways clinicians can leverage technology to care for adolescents years before COVID-19 exposed the challenges and advantages of telehealth.

Dr. Trent, a pediatrician and adolescent medicine specialist and professor of pediatrics at Johns Hopkins University, Baltimore, has long believed that the phones in her patients’ pockets have the potential to improve the sexual health of youth. The pandemic has only made that view stronger.

“They’re a generation that’s really wired and online,” Dr. Trent told this news organization. “I think that we can meet them in that space.”

Her research has incorporated texting, apps, and videos. Out of necessity, technology increasingly became part of patient care during the pandemic. “We had to stretch our ability to do some basic triage and assessments of patients online,” Dr. Trent said.

Even when clinics are closed, doctors might be able to provide initial care remotely, such as writing prescriptions to manage symptoms or directing patients to a lab for testing.

Telemedicine could allow a clinician to guide a teenager who thinks they might be pregnant to take a store-bought test and avoid possible exposure to COVID-19 in the ED, for instance.

But doctors have concerns about the legal and practical limits of privacy and confidentiality. Who else is at home listening to a phone conversation? Are parents accessing the patient’s online portal? Will parents receive an explanation of benefits that lists testing for a sexually transmitted infection, or see a testing kit that is delivered to their home?

When a young patient needs in-person care, transportation can be a barrier. And then there’s the matter of clinicians being able to bill for telehealth services.

Practices are learning how to navigate these issues, and relevant laws vary by state.

“I think this is going to become part of standard practice,” Dr. Trent said. “I think we have to do the hard work to make sure that it’s safe, that it’s accessible, and that it is actually improving care.”
 

Texts, apps, videos

In one early study, Dr. Trent and colleagues found that showing adolescents with pelvic inflammatory disease a 6-minute video may improve treatment rates for their sexual partners.

Another study provided preliminary evidence that text messaging support might improve clinic attendance for moderately long-acting reversible contraception.

A third trial showed that adolescents and young adults with pelvic inflammatory disease who were randomly assigned to receive text-message prompts to take their medications and provide information about the doses they consumed had greater decreases in Neisseria gonorrhoeae and Chlamydia trachomatis infections, compared with patients who received standard care.

Dr. Trent and coinvestigators are assessing a technology-based intervention for youth with HIV, in which patients can use an app to submit videos of themselves taking antiretroviral therapy and report any side effects. The technology provides a way to monitor patients remotely and support them between visits, she said.
 

Will pandemic-driven options remain?

In 2020, Laura D. Lindberg, PhD, principal research scientist at the Guttmacher Institute in New York, and coauthors discussed the possible ramifications of the pandemic on the sexual and reproductive health of adolescents and young adults.

If telemedicine options driven by COVID-19 are here to stay, adolescents and young adults could be “the age group most likely to continue that approach rather than returning to traditional in-person visits,” the researchers wrote. “Innovations in health care service provision, such as use of telemedicine and obtaining contraceptives and STI testing by mail, will help expand access to [sexual and reproductive health] care for young people.”

At the 2021 annual conference of the American Academy of Pediatrics, Dr. Trent described telehealth as a viable way to provide sexual and reproductive health care to adolescents and young adults, including anticipatory guidance, contraception counseling, coordination of follow-up care and testing, and connecting patients to resources.

Her presentation cited several websites that can help patients receive testing for STIs, including Yes Means Test, the Centers for Disease Control and Prevention’s GetTested page, and I Want the Kit. Planned Parenthood has telehealth options, and the Kaiser Family Foundation compiled information about 26 online platforms that were providing contraception or STI services.
 

Who else is in the room?

“There’s only so much time in the day and so many patients you can see, regardless of whether you have telehealth or not,” said David L. Bell, MD, MPH, president of the Society for Adolescent Health and Medicine and a coauthor of the Perspectives on Sexual and Reproductive Health paper. In addition, “you never know who else is in the room” with the patient on the other end, added Dr. Bell, a professor of population and family health and pediatrics at the Columbia University Medical Center and medical director of the Young Men’s Clinic, both in New York.

In some respects, young patients may not be able to participate in telehealth visits the same way they would in a medical office, Dr. Trent acknowledged. Encouraging the use of headphones is one way to help protect confidentiality when talking with patients who are at home and might not be alone.

But if patients are able to find a private space for remote visits, they might be more open than usual. In that way, telemedicine could provide additional opportunities to address issues like substance use disorders and mental health, as well, she said.

“Then, if they need something, we have to problem solve,” Dr. Trent said. Next steps may involve engaging a parent or getting the patient to a lab or the clinic.
 

Sex ed may be lacking

The Perspectives article also raised concerns that the pandemic might exacerbate shortcomings in sex education, which already may have been lacking.

“Before the pandemic, schools were a key source of formal sex education for young people,” the authors wrote. “Sex education, which was already limited in many areas of the country, has likely not been included in the national shift to online learning. Even when in-person schooling resumes, missed sex education instruction is unlikely to be made up, given the modest attention it received prior to the pandemic.”

A recently published study in the Journal of Adolescent Health indicates that American teenagers currently receive less formal sex education than they did 25 years ago, with “troubling” inequities by race.

Researchers surveyed adolescents about what they had learned about topics such as how to say no to sex, methods of birth control and where to get them, and STIs.

Dr. Lindberg and Leslie M. Kantor, PhD, MPH, professor and chair of the department of urban-global public health at Rutgers University, Newark, N.J., conducted the analysis.

“Pediatricians and other health care providers that work with children and adolescents have a critical role to play in providing information about sexuality to both the patients and to the parents,” said Dr. Kantor, who also coauthored the Perspectives article with Dr. Lindberg and Dr. Bell. The new research “shows that doctors play an even more critical role, because they can’t assume that their patients are going to get the information that they need in a timely way from schools.”

By age 15, 21% of girls and 20% of boys have had sexual intercourse at least once, according to data from the 2015-2017 National Survey of Family Growth. By age 17, the percentages were 53% of girls and 48% of boys. By age 20, the percentages were 79% of women and 77% of men. The CDC’s 2021 guidelines on treatment and screening for STIs note that prevalence rates of certain infections – such as chlamydia and gonorrhea in females – are highest among adolescents and young adults.

Those trends underscore the importance of counseling on sexual health that clinicians can provide, but time constraints may limit how much they can discuss in a single session with a patient. To cover all topics that are important to parents and patients, doctors may need to discuss sexual and reproductive health sooner and more frequently.

Young people are getting more and more explicit information from their phones and media, yet educators are giving them less information to navigate these topics and learn what’s real, Dr. Kantor said. That mismatch can be toxic. In a December 2021 interview with Howard Stern, the pop star Billie Eilish said she started watching pornography at about age 11 and frequently watched videos that were violent. “I think it really destroyed my brain and I feel incredibly devastated that I was exposed to so much porn,” Ms. Eilish told Mr. Stern.

Researchers and a psychologist told CNN that the singer’s story may be typical. It also highlights a need to be aware of kids’ online activities and to have conversations about how pornography may not depict healthy interactions, they said.

Beyond discussing a plan for preventing pregnancy and STIs, Dr. Kantor encouraged discussions about what constitutes healthy relationships, as well as check-ins about intimate partner violence and how romantic relationships are going.

“I think for pediatricians and for parents, it’s a muscle,” she said. “As you bring up these topics more, listen, and respond, you get more comfortable with it.”

Dr. Trent has served as an advisory board member on a sexual health council for Trojan (Church & Dwight Company) and has received research funding from Hologic and research supplies from SpeeDx. Dr. Bell has received funds from the Merck Foundation, Merck, and Gilead. Dr. Kantor had no disclosures.

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

A COVID-19 outbreak has occurred at one of the most remote places on earth – the Princess Elisabeth Polar Station in Antarctica.

Two-thirds of the 25 workers have tested positive at the station, despite all of them being fully vaccinated and going through several testing stages before being allowed entrance, the Belgium publication Le Soir reported.

So far, all the cases are mild at the station, which is owned by Belgium and operated by a private group: the International Polar Foundation.

The first case was discovered Dec. 14 among a group that arrived a week earlier in Antarctica, Le Soir reported. The first three people to test positive evacuated Dec. 23, Le Soir said, but the virus continued to spread among the remaining workers at the base.

Le Soir, citing a virologist, said the Omicron variant probably caused the outbreak, because the crew made its last stop in South Africa before arriving in Antarctica.

New arrivals to the station have been put on hold until the outbreak is brought under control, and one of the missions planned for the base has been postponed, Le Soir said.

“The situation isn’t dramatic,” Joseph Cheek, a project manager for the International Polar Foundation, told the BBC. “While it has been an inconvenience to have to quarantine certain members of the staff who caught the virus, it hasn’t significantly affected our work at the station overall.”

The BBC said there was another COVID outbreak in Antarctica about a year ago at the Bernardo O’Higgins research station operated by Chile.

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

A COVID-19 outbreak has occurred at one of the most remote places on earth – the Princess Elisabeth Polar Station in Antarctica.

Two-thirds of the 25 workers have tested positive at the station, despite all of them being fully vaccinated and going through several testing stages before being allowed entrance, the Belgium publication Le Soir reported.

So far, all the cases are mild at the station, which is owned by Belgium and operated by a private group: the International Polar Foundation.

The first case was discovered Dec. 14 among a group that arrived a week earlier in Antarctica, Le Soir reported. The first three people to test positive evacuated Dec. 23, Le Soir said, but the virus continued to spread among the remaining workers at the base.

Le Soir, citing a virologist, said the Omicron variant probably caused the outbreak, because the crew made its last stop in South Africa before arriving in Antarctica.

New arrivals to the station have been put on hold until the outbreak is brought under control, and one of the missions planned for the base has been postponed, Le Soir said.

“The situation isn’t dramatic,” Joseph Cheek, a project manager for the International Polar Foundation, told the BBC. “While it has been an inconvenience to have to quarantine certain members of the staff who caught the virus, it hasn’t significantly affected our work at the station overall.”

The BBC said there was another COVID outbreak in Antarctica about a year ago at the Bernardo O’Higgins research station operated by Chile.

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

A COVID-19 outbreak has occurred at one of the most remote places on earth – the Princess Elisabeth Polar Station in Antarctica.

Two-thirds of the 25 workers have tested positive at the station, despite all of them being fully vaccinated and going through several testing stages before being allowed entrance, the Belgium publication Le Soir reported.

So far, all the cases are mild at the station, which is owned by Belgium and operated by a private group: the International Polar Foundation.

The first case was discovered Dec. 14 among a group that arrived a week earlier in Antarctica, Le Soir reported. The first three people to test positive evacuated Dec. 23, Le Soir said, but the virus continued to spread among the remaining workers at the base.

Le Soir, citing a virologist, said the Omicron variant probably caused the outbreak, because the crew made its last stop in South Africa before arriving in Antarctica.

New arrivals to the station have been put on hold until the outbreak is brought under control, and one of the missions planned for the base has been postponed, Le Soir said.

“The situation isn’t dramatic,” Joseph Cheek, a project manager for the International Polar Foundation, told the BBC. “While it has been an inconvenience to have to quarantine certain members of the staff who caught the virus, it hasn’t significantly affected our work at the station overall.”

The BBC said there was another COVID outbreak in Antarctica about a year ago at the Bernardo O’Higgins research station operated by Chile.

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

The CDC has released two studies that showed vaccine safety for ages 5-11 and emphasized the importance of vaccinating children against the coronavirus to prevent serious illness and hospitalization.

In one study published in the Morbidity and Mortality Weekly Report, researchers found that serious problems were rare among children who had received the Pfizer vaccine.

In another study, researchers looked at hundreds of pediatric hospitalizations from the summer and found that nearly all of children who developed severe COVID-19 weren’t fully vaccinated.

“This study demonstrates that unvaccinated children hospitalized for COVID-19 could experience severe disease and reinforces the importance of vaccination of all eligible children to provide individual protection and to protect those who are not yet eligible to be vaccinated,” the authors of the second study wrote.

Nearly 9 million doses of the Pfizer vaccine have been given to children aged 5-11 in the United States so far, according to The New York Times. By mid-December, or about 6 weeks after the age group became eligible for vaccination in October, the CDC said it had received very few reports of serious problems.

CDC researchers evaluated reports received from doctors and the public, including survey responses from parents and guardians of about 43,000 children between ages 5 and 11. Many children reported nonserious events such as pain at the injection site, fatigue, or a headache, especially after the second dose.

Among more than 4,100 adverse event reports received in November and December, 100 were for serious events, with the most common being fever or vomiting.

The CDC had received 11 verified reports of myocarditis, or inflammation of the heart muscle, which has been noted as a rare side effect of the vaccine among boys and men between ages 12 and 29. Among those, seven children had already recovered and four were still recovering at the time of the report.

The CDC received reports of two deaths – girls who were aged 5 and 6 – who had chronic medical conditions and were in “fragile health” before their shots. The agency said that no data suggested a “causal association between death and vaccination.”

The CDC also received some reports that children between ages 5 and 11 received the larger vaccine dose meant for older children and adults. Most reports said that the children didn’t experience any problems after an incorrect dose.

In a separate study about pediatric hospitalizations, CDC researchers looked at more than 700 children under age 18 who were hospitalized for COVID-19 in July and August at six children’s hospitals in Arkansas, Florida, Illinois, Louisiana, Texas, and Washington, D.C.

Researchers found that only one of the 272 vaccine-eligible patients between ages 12 and 17 had been fully vaccinated, and 12 were partially vaccinated.

In addition, about two-thirds of the hospitalized children between ages 12 and 17 had an underlying condition, with obesity being the most common. About one-third of children under age 5 had more than one viral infection.

Overall, about 30% of the children had to be treated in intensive care units, and 15% needed invasive medical ventilation, CDC researchers found. Nearly 3% had multisystem inflammatory syndrome in children, or MIS-C, which is a rare but serious inflammatory condition associated with COVID-19.

Among all the children hospitalized with COVID-19, about 1.5% died.

“Few vaccine-eligible patients hospitalized for COVID-19 were vaccinated, highlighting the importance of vaccination for those aged ≥5 years and other prevention strategies to protect children and adolescents from COVID-19, particularly those with underlying medical conditions,” study authors wrote.

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

The CDC has released two studies that showed vaccine safety for ages 5-11 and emphasized the importance of vaccinating children against the coronavirus to prevent serious illness and hospitalization.

In one study published in the Morbidity and Mortality Weekly Report, researchers found that serious problems were rare among children who had received the Pfizer vaccine.

In another study, researchers looked at hundreds of pediatric hospitalizations from the summer and found that nearly all of children who developed severe COVID-19 weren’t fully vaccinated.

“This study demonstrates that unvaccinated children hospitalized for COVID-19 could experience severe disease and reinforces the importance of vaccination of all eligible children to provide individual protection and to protect those who are not yet eligible to be vaccinated,” the authors of the second study wrote.

Nearly 9 million doses of the Pfizer vaccine have been given to children aged 5-11 in the United States so far, according to The New York Times. By mid-December, or about 6 weeks after the age group became eligible for vaccination in October, the CDC said it had received very few reports of serious problems.

CDC researchers evaluated reports received from doctors and the public, including survey responses from parents and guardians of about 43,000 children between ages 5 and 11. Many children reported nonserious events such as pain at the injection site, fatigue, or a headache, especially after the second dose.

Among more than 4,100 adverse event reports received in November and December, 100 were for serious events, with the most common being fever or vomiting.

The CDC had received 11 verified reports of myocarditis, or inflammation of the heart muscle, which has been noted as a rare side effect of the vaccine among boys and men between ages 12 and 29. Among those, seven children had already recovered and four were still recovering at the time of the report.

The CDC received reports of two deaths – girls who were aged 5 and 6 – who had chronic medical conditions and were in “fragile health” before their shots. The agency said that no data suggested a “causal association between death and vaccination.”

The CDC also received some reports that children between ages 5 and 11 received the larger vaccine dose meant for older children and adults. Most reports said that the children didn’t experience any problems after an incorrect dose.

In a separate study about pediatric hospitalizations, CDC researchers looked at more than 700 children under age 18 who were hospitalized for COVID-19 in July and August at six children’s hospitals in Arkansas, Florida, Illinois, Louisiana, Texas, and Washington, D.C.

Researchers found that only one of the 272 vaccine-eligible patients between ages 12 and 17 had been fully vaccinated, and 12 were partially vaccinated.

In addition, about two-thirds of the hospitalized children between ages 12 and 17 had an underlying condition, with obesity being the most common. About one-third of children under age 5 had more than one viral infection.

Overall, about 30% of the children had to be treated in intensive care units, and 15% needed invasive medical ventilation, CDC researchers found. Nearly 3% had multisystem inflammatory syndrome in children, or MIS-C, which is a rare but serious inflammatory condition associated with COVID-19.

Among all the children hospitalized with COVID-19, about 1.5% died.

“Few vaccine-eligible patients hospitalized for COVID-19 were vaccinated, highlighting the importance of vaccination for those aged ≥5 years and other prevention strategies to protect children and adolescents from COVID-19, particularly those with underlying medical conditions,” study authors wrote.

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

The CDC has released two studies that showed vaccine safety for ages 5-11 and emphasized the importance of vaccinating children against the coronavirus to prevent serious illness and hospitalization.

In one study published in the Morbidity and Mortality Weekly Report, researchers found that serious problems were rare among children who had received the Pfizer vaccine.

In another study, researchers looked at hundreds of pediatric hospitalizations from the summer and found that nearly all of children who developed severe COVID-19 weren’t fully vaccinated.

“This study demonstrates that unvaccinated children hospitalized for COVID-19 could experience severe disease and reinforces the importance of vaccination of all eligible children to provide individual protection and to protect those who are not yet eligible to be vaccinated,” the authors of the second study wrote.

Nearly 9 million doses of the Pfizer vaccine have been given to children aged 5-11 in the United States so far, according to The New York Times. By mid-December, or about 6 weeks after the age group became eligible for vaccination in October, the CDC said it had received very few reports of serious problems.

CDC researchers evaluated reports received from doctors and the public, including survey responses from parents and guardians of about 43,000 children between ages 5 and 11. Many children reported nonserious events such as pain at the injection site, fatigue, or a headache, especially after the second dose.

Among more than 4,100 adverse event reports received in November and December, 100 were for serious events, with the most common being fever or vomiting.

The CDC had received 11 verified reports of myocarditis, or inflammation of the heart muscle, which has been noted as a rare side effect of the vaccine among boys and men between ages 12 and 29. Among those, seven children had already recovered and four were still recovering at the time of the report.

The CDC received reports of two deaths – girls who were aged 5 and 6 – who had chronic medical conditions and were in “fragile health” before their shots. The agency said that no data suggested a “causal association between death and vaccination.”

The CDC also received some reports that children between ages 5 and 11 received the larger vaccine dose meant for older children and adults. Most reports said that the children didn’t experience any problems after an incorrect dose.

In a separate study about pediatric hospitalizations, CDC researchers looked at more than 700 children under age 18 who were hospitalized for COVID-19 in July and August at six children’s hospitals in Arkansas, Florida, Illinois, Louisiana, Texas, and Washington, D.C.

Researchers found that only one of the 272 vaccine-eligible patients between ages 12 and 17 had been fully vaccinated, and 12 were partially vaccinated.

In addition, about two-thirds of the hospitalized children between ages 12 and 17 had an underlying condition, with obesity being the most common. About one-third of children under age 5 had more than one viral infection.

Overall, about 30% of the children had to be treated in intensive care units, and 15% needed invasive medical ventilation, CDC researchers found. Nearly 3% had multisystem inflammatory syndrome in children, or MIS-C, which is a rare but serious inflammatory condition associated with COVID-19.

Among all the children hospitalized with COVID-19, about 1.5% died.

“Few vaccine-eligible patients hospitalized for COVID-19 were vaccinated, highlighting the importance of vaccination for those aged ≥5 years and other prevention strategies to protect children and adolescents from COVID-19, particularly those with underlying medical conditions,” study authors wrote.

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

The Food and Drug Administration on Jan. 3 authorized the first COVID-19 vaccine booster dose for American adolescents ages 12 to 15.

Besides updating the authorization for the Pfizer COVID-19 vaccine, the agency also shortened the recommended time between a second dose and the booster to 5 months or more, based on new evidence. In addition, a third primary series dose is now authorized for certain immunocompromised children 5 years to 11 years old. Full details are available in an FDA news release.

The amended emergency use authorization (EUA) only applies to the Pfizer vaccine, said acting FDA Commissioner Janet Woodcock, MD.

“Just to make sure every everyone is clear on this, right now: If you got [Johnson & Johnson’s one-dose vaccine], you get a booster after 2 months. If you got Moderna, you can get a booster at 6 months or beyond,” she said during a media briefing.

What is new, she said, is “if you got Pfizer as your primary series, you can get a booster at 5 months or beyond.”
 

A lower risk of myocarditis?

Asked about concerns about the risk of myocarditis with vaccination in the 12- to 15-year age group, Dr. Woodcock said they expect it would be “extremely rare with the third dose.”

“We have the real-world evidence from the Israeli experience to help us with that analysis,” she said.

The data so far consistently points to a higher risk of myocarditis after a second mRNA vaccine dose among males, from teenagers to 30-year-olds, with a peak at about 16 to 17 years of age, Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said during the media call.

The risk of myocarditis is about 2 to 3 times higher after a second vaccine dose, compared to a booster shot, Dr. Marks said, based on available data. It may be related to the closer dose timing of the second dose versus a third, he added.

“The inference here is that on the risk of myocarditis with third doses in the 12- to 15-year age range is likely to be quite acceptable,” he said.

Dr. Marks also pointed out that most cases of myocarditis clear up quickly.

“We’re not seeing long-lasting effects. That’s not to say that we don’t care about this and that it’s not important,” he said.

“But what it is saying is that in the setting of a tremendous number of Omicron and Delta cases in this country, the potential benefits of getting vaccinated in this age group outweigh that risk,” Dr. Marks said. “We can look at that risk-benefit and still feel comfortable.”

He said that “the really overwhelming majority of these cases, 98%, have been mild” -- shown by a 1-day median hospital stay.

Even so, the FDA plans to continue monitoring for the risk of myocarditis “very closely,” he said.

Interestingly, swollen underarm lymph nodes were seen more frequently after the booster dose than after the second dose of a two-dose primary series, the FDA said.

Reducing the time between primary vaccination with the Pfizer vaccine -- two initial doses -- and the booster shot from 6 months to 5 months is based on decreasing efficacy data that the drugmaker submitted to the FDA.

The 5-month interval was evaluated in a study from Israel published Dec. 21 in the New England Journal of Medicine .
 

Mixing and matching vaccines

Less clear at the moment is guidance about boosters for people who opted to mix and match their primary vaccine series.

“There was a mix-and-match study that was done which showed that in some cases, the mixing and matching … of an adenoviral record vaccine and an mRNA vaccine seem to give a very good immune response,” Dr. Marks said.

Once more data comes in on mixing and matching, “we’ll analyze them and then potentially make recommendations,” he said.
 

‘It’s not too late’

No federal government media briefing on COVID-19 would be complete without a plea for the unvaccinated to get immunized.

“We’re talking a lot about boosters right now, but it’s not too late for those who have not gotten a vaccine to get a vaccine,” Dr. Marks said, referring to the tens of millions of Americans who remain unvaccinated at the beginning of 2022.

“We know from our previous studies that even a single dose of the vaccine -- and probably two doses -- can help prevent the worst outcomes from COVID-19, including hospitalization and death.”

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

The Food and Drug Administration on Jan. 3 authorized the first COVID-19 vaccine booster dose for American adolescents ages 12 to 15.

Besides updating the authorization for the Pfizer COVID-19 vaccine, the agency also shortened the recommended time between a second dose and the booster to 5 months or more, based on new evidence. In addition, a third primary series dose is now authorized for certain immunocompromised children 5 years to 11 years old. Full details are available in an FDA news release.

The amended emergency use authorization (EUA) only applies to the Pfizer vaccine, said acting FDA Commissioner Janet Woodcock, MD.

“Just to make sure every everyone is clear on this, right now: If you got [Johnson & Johnson’s one-dose vaccine], you get a booster after 2 months. If you got Moderna, you can get a booster at 6 months or beyond,” she said during a media briefing.

What is new, she said, is “if you got Pfizer as your primary series, you can get a booster at 5 months or beyond.”
 

A lower risk of myocarditis?

Asked about concerns about the risk of myocarditis with vaccination in the 12- to 15-year age group, Dr. Woodcock said they expect it would be “extremely rare with the third dose.”

“We have the real-world evidence from the Israeli experience to help us with that analysis,” she said.

The data so far consistently points to a higher risk of myocarditis after a second mRNA vaccine dose among males, from teenagers to 30-year-olds, with a peak at about 16 to 17 years of age, Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said during the media call.

The risk of myocarditis is about 2 to 3 times higher after a second vaccine dose, compared to a booster shot, Dr. Marks said, based on available data. It may be related to the closer dose timing of the second dose versus a third, he added.

“The inference here is that on the risk of myocarditis with third doses in the 12- to 15-year age range is likely to be quite acceptable,” he said.

Dr. Marks also pointed out that most cases of myocarditis clear up quickly.

“We’re not seeing long-lasting effects. That’s not to say that we don’t care about this and that it’s not important,” he said.

“But what it is saying is that in the setting of a tremendous number of Omicron and Delta cases in this country, the potential benefits of getting vaccinated in this age group outweigh that risk,” Dr. Marks said. “We can look at that risk-benefit and still feel comfortable.”

He said that “the really overwhelming majority of these cases, 98%, have been mild” -- shown by a 1-day median hospital stay.

Even so, the FDA plans to continue monitoring for the risk of myocarditis “very closely,” he said.

Interestingly, swollen underarm lymph nodes were seen more frequently after the booster dose than after the second dose of a two-dose primary series, the FDA said.

Reducing the time between primary vaccination with the Pfizer vaccine -- two initial doses -- and the booster shot from 6 months to 5 months is based on decreasing efficacy data that the drugmaker submitted to the FDA.

The 5-month interval was evaluated in a study from Israel published Dec. 21 in the New England Journal of Medicine .
 

Mixing and matching vaccines

Less clear at the moment is guidance about boosters for people who opted to mix and match their primary vaccine series.

“There was a mix-and-match study that was done which showed that in some cases, the mixing and matching … of an adenoviral record vaccine and an mRNA vaccine seem to give a very good immune response,” Dr. Marks said.

Once more data comes in on mixing and matching, “we’ll analyze them and then potentially make recommendations,” he said.
 

‘It’s not too late’

No federal government media briefing on COVID-19 would be complete without a plea for the unvaccinated to get immunized.

“We’re talking a lot about boosters right now, but it’s not too late for those who have not gotten a vaccine to get a vaccine,” Dr. Marks said, referring to the tens of millions of Americans who remain unvaccinated at the beginning of 2022.

“We know from our previous studies that even a single dose of the vaccine -- and probably two doses -- can help prevent the worst outcomes from COVID-19, including hospitalization and death.”

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

The Food and Drug Administration on Jan. 3 authorized the first COVID-19 vaccine booster dose for American adolescents ages 12 to 15.

Besides updating the authorization for the Pfizer COVID-19 vaccine, the agency also shortened the recommended time between a second dose and the booster to 5 months or more, based on new evidence. In addition, a third primary series dose is now authorized for certain immunocompromised children 5 years to 11 years old. Full details are available in an FDA news release.

The amended emergency use authorization (EUA) only applies to the Pfizer vaccine, said acting FDA Commissioner Janet Woodcock, MD.

“Just to make sure every everyone is clear on this, right now: If you got [Johnson & Johnson’s one-dose vaccine], you get a booster after 2 months. If you got Moderna, you can get a booster at 6 months or beyond,” she said during a media briefing.

What is new, she said, is “if you got Pfizer as your primary series, you can get a booster at 5 months or beyond.”
 

A lower risk of myocarditis?

Asked about concerns about the risk of myocarditis with vaccination in the 12- to 15-year age group, Dr. Woodcock said they expect it would be “extremely rare with the third dose.”

“We have the real-world evidence from the Israeli experience to help us with that analysis,” she said.

The data so far consistently points to a higher risk of myocarditis after a second mRNA vaccine dose among males, from teenagers to 30-year-olds, with a peak at about 16 to 17 years of age, Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, said during the media call.

The risk of myocarditis is about 2 to 3 times higher after a second vaccine dose, compared to a booster shot, Dr. Marks said, based on available data. It may be related to the closer dose timing of the second dose versus a third, he added.

“The inference here is that on the risk of myocarditis with third doses in the 12- to 15-year age range is likely to be quite acceptable,” he said.

Dr. Marks also pointed out that most cases of myocarditis clear up quickly.

“We’re not seeing long-lasting effects. That’s not to say that we don’t care about this and that it’s not important,” he said.

“But what it is saying is that in the setting of a tremendous number of Omicron and Delta cases in this country, the potential benefits of getting vaccinated in this age group outweigh that risk,” Dr. Marks said. “We can look at that risk-benefit and still feel comfortable.”

He said that “the really overwhelming majority of these cases, 98%, have been mild” -- shown by a 1-day median hospital stay.

Even so, the FDA plans to continue monitoring for the risk of myocarditis “very closely,” he said.

Interestingly, swollen underarm lymph nodes were seen more frequently after the booster dose than after the second dose of a two-dose primary series, the FDA said.

Reducing the time between primary vaccination with the Pfizer vaccine -- two initial doses -- and the booster shot from 6 months to 5 months is based on decreasing efficacy data that the drugmaker submitted to the FDA.

The 5-month interval was evaluated in a study from Israel published Dec. 21 in the New England Journal of Medicine .
 

Mixing and matching vaccines

Less clear at the moment is guidance about boosters for people who opted to mix and match their primary vaccine series.

“There was a mix-and-match study that was done which showed that in some cases, the mixing and matching … of an adenoviral record vaccine and an mRNA vaccine seem to give a very good immune response,” Dr. Marks said.

Once more data comes in on mixing and matching, “we’ll analyze them and then potentially make recommendations,” he said.
 

‘It’s not too late’

No federal government media briefing on COVID-19 would be complete without a plea for the unvaccinated to get immunized.

“We’re talking a lot about boosters right now, but it’s not too late for those who have not gotten a vaccine to get a vaccine,” Dr. Marks said, referring to the tens of millions of Americans who remain unvaccinated at the beginning of 2022.

“We know from our previous studies that even a single dose of the vaccine -- and probably two doses -- can help prevent the worst outcomes from COVID-19, including hospitalization and death.”

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

As the United States enters a third year of the COVID-19 pandemic, case numbers are higher than ever and disrupting businesses, travel plans, and school schedules.

The United States is reporting a 7-day average of more than 386,000 cases after several record-breaking days, according to the data tracker by the New York Times. The United States surpassed 585,000 cases on Dec. 30, setting a new record before the New Year’s holiday.

New York, Washington, D.C., and other states along the East Coast are leading the national surge. New York reported more than 85,000 new cases on the last day of 2021, marking the highest 1-day total in the state since the pandemic began.

“As we fight the winter surge, we need to keep the most vulnerable among us in mind – do what you can to keep others in your community safe from COVID-19,” New York Gov. Kathy Hochul said in a statement on Jan. 1, 2022.

“Wear a mask, wash your hands, and take advantage of the best tool we have at our disposal – the vaccine,” she said.

The 2021 winter surge in the United States peaked around Jan. 12, which may suggest that the country has a week or so before the current wave reaches its height and begins to drop, the newspaper reported.

In the meantime, people are dealing with disruptions as they return from holiday travel and begin the new year. Airlines canceled more than 2,700 flights on Jan. 1 and more than 1,900 flights on Jan. 2, bringing the total since Christmas Eve to more than 14,000 canceled flights.

About half of cancellations were connected to wintry weather at key airline hubs in Chicago and Denver, the newspaper reported, as well as ongoing flight crew shortages caused by the Omicron variant.

More disruptions could continue, the Federal Aviation Administration warned, as an increasing number of its air-traffic control employees test positive for COVID-19.

“To maintain safety, traffic volumes at some facilities could be reduced, which might result in delays during busy periods,” an FAA spokesman told The Wall Street Journal.

The current COVID-19 surge will also affect businesses and schools as the new year begins. A growing number of universities are opting to start the next semester with remote instruction.

American University, Duke University, and Michigan State University announced in recent days that they would delay in-person classes to slow the spread of the coronavirus on campus. They will begin classes online on Jan. 10 and return to campus the following week or later.

“I realize that students prefer to be in person, and so do I. But it is important that we do so in a safe manner,” Samuel Stanley Jr., MD, president of Michigan State University, said in a statement on New Year’s Eve.

K-12 school districts are deciding how to adapt as well. Some districts are bringing back mask requirements, and some are ramping up testing. Others are moving to remote learning – and signaling the need for flexibility as the Omicron variant brings new surprises.

“Change has been the only constant in this fight,” Roger Leon, the superintendent for Newark (N.J.) Public Schools, wrote in a note to parents. He announced on Dec. 30, 2021, that students would learn remotely for at least the first 2 weeks of the new year.

This continues “to be a brutal, relentless, and ruthless virus that rears its ugly head at inopportune times,” he said.

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

As the United States enters a third year of the COVID-19 pandemic, case numbers are higher than ever and disrupting businesses, travel plans, and school schedules.

The United States is reporting a 7-day average of more than 386,000 cases after several record-breaking days, according to the data tracker by the New York Times. The United States surpassed 585,000 cases on Dec. 30, setting a new record before the New Year’s holiday.

New York, Washington, D.C., and other states along the East Coast are leading the national surge. New York reported more than 85,000 new cases on the last day of 2021, marking the highest 1-day total in the state since the pandemic began.

“As we fight the winter surge, we need to keep the most vulnerable among us in mind – do what you can to keep others in your community safe from COVID-19,” New York Gov. Kathy Hochul said in a statement on Jan. 1, 2022.

“Wear a mask, wash your hands, and take advantage of the best tool we have at our disposal – the vaccine,” she said.

The 2021 winter surge in the United States peaked around Jan. 12, which may suggest that the country has a week or so before the current wave reaches its height and begins to drop, the newspaper reported.

In the meantime, people are dealing with disruptions as they return from holiday travel and begin the new year. Airlines canceled more than 2,700 flights on Jan. 1 and more than 1,900 flights on Jan. 2, bringing the total since Christmas Eve to more than 14,000 canceled flights.

About half of cancellations were connected to wintry weather at key airline hubs in Chicago and Denver, the newspaper reported, as well as ongoing flight crew shortages caused by the Omicron variant.

More disruptions could continue, the Federal Aviation Administration warned, as an increasing number of its air-traffic control employees test positive for COVID-19.

“To maintain safety, traffic volumes at some facilities could be reduced, which might result in delays during busy periods,” an FAA spokesman told The Wall Street Journal.

The current COVID-19 surge will also affect businesses and schools as the new year begins. A growing number of universities are opting to start the next semester with remote instruction.

American University, Duke University, and Michigan State University announced in recent days that they would delay in-person classes to slow the spread of the coronavirus on campus. They will begin classes online on Jan. 10 and return to campus the following week or later.

“I realize that students prefer to be in person, and so do I. But it is important that we do so in a safe manner,” Samuel Stanley Jr., MD, president of Michigan State University, said in a statement on New Year’s Eve.

K-12 school districts are deciding how to adapt as well. Some districts are bringing back mask requirements, and some are ramping up testing. Others are moving to remote learning – and signaling the need for flexibility as the Omicron variant brings new surprises.

“Change has been the only constant in this fight,” Roger Leon, the superintendent for Newark (N.J.) Public Schools, wrote in a note to parents. He announced on Dec. 30, 2021, that students would learn remotely for at least the first 2 weeks of the new year.

This continues “to be a brutal, relentless, and ruthless virus that rears its ugly head at inopportune times,” he said.

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

As the United States enters a third year of the COVID-19 pandemic, case numbers are higher than ever and disrupting businesses, travel plans, and school schedules.

The United States is reporting a 7-day average of more than 386,000 cases after several record-breaking days, according to the data tracker by the New York Times. The United States surpassed 585,000 cases on Dec. 30, setting a new record before the New Year’s holiday.

New York, Washington, D.C., and other states along the East Coast are leading the national surge. New York reported more than 85,000 new cases on the last day of 2021, marking the highest 1-day total in the state since the pandemic began.

“As we fight the winter surge, we need to keep the most vulnerable among us in mind – do what you can to keep others in your community safe from COVID-19,” New York Gov. Kathy Hochul said in a statement on Jan. 1, 2022.

“Wear a mask, wash your hands, and take advantage of the best tool we have at our disposal – the vaccine,” she said.

The 2021 winter surge in the United States peaked around Jan. 12, which may suggest that the country has a week or so before the current wave reaches its height and begins to drop, the newspaper reported.

In the meantime, people are dealing with disruptions as they return from holiday travel and begin the new year. Airlines canceled more than 2,700 flights on Jan. 1 and more than 1,900 flights on Jan. 2, bringing the total since Christmas Eve to more than 14,000 canceled flights.

About half of cancellations were connected to wintry weather at key airline hubs in Chicago and Denver, the newspaper reported, as well as ongoing flight crew shortages caused by the Omicron variant.

More disruptions could continue, the Federal Aviation Administration warned, as an increasing number of its air-traffic control employees test positive for COVID-19.

“To maintain safety, traffic volumes at some facilities could be reduced, which might result in delays during busy periods,” an FAA spokesman told The Wall Street Journal.

The current COVID-19 surge will also affect businesses and schools as the new year begins. A growing number of universities are opting to start the next semester with remote instruction.

American University, Duke University, and Michigan State University announced in recent days that they would delay in-person classes to slow the spread of the coronavirus on campus. They will begin classes online on Jan. 10 and return to campus the following week or later.

“I realize that students prefer to be in person, and so do I. But it is important that we do so in a safe manner,” Samuel Stanley Jr., MD, president of Michigan State University, said in a statement on New Year’s Eve.

K-12 school districts are deciding how to adapt as well. Some districts are bringing back mask requirements, and some are ramping up testing. Others are moving to remote learning – and signaling the need for flexibility as the Omicron variant brings new surprises.

“Change has been the only constant in this fight,” Roger Leon, the superintendent for Newark (N.J.) Public Schools, wrote in a note to parents. He announced on Dec. 30, 2021, that students would learn remotely for at least the first 2 weeks of the new year.

This continues “to be a brutal, relentless, and ruthless virus that rears its ugly head at inopportune times,” he said.

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

A global study led by researchers at University College London, published Dec. 30, 2021, in the New England Journal of Medicine, found that a regimen based on a once-a-day small dolutegravir tablet was more effective at suppressing HIV than standard treatments. Dolutegravir suppresses HIV by inhibiting integrase, an enzyme that the virus needs to replicate.

The pill-based regimen, which researchers described as easier to take than standard treatment, reduced the chances of treatment failure among children aged 3-18 years by about 40%, compared with other treatments. Dolutegravir is already used for the suppression of HIV in adults.

“About 1.8 million children live with HIV but they have had limited treatment options, with medicines that taste unpalatable, that need to be taken twice a day, or that come in large pills that are difficult to swallow” said lead author Anna Turkova, MD, from the MRC clinical trials unit at UCL. “Dolutegravir is given in small tablets usually once a day and the baby pills can be dispersed in water, meaning it’s a lot easier for young children to take. This is important in encouraging uptake of the treatment and adherence to it over many years.

“Sadly, only about half of children living with HIV are currently receiving treatment, and those who are not treated face high risks of impaired immunity and worsening health.”
 

Study details

The randomized controlled trial, called ODYSSEY, involved more than 700 children from 29 clinical centers located in Africa, Europe, and Asia. The children were given either dolutegravir or standard anti-HIV drugs, and were followed up for at least 2 years.

The study showed that 14% of children receiving dolutegravir experienced treatment failure over 2 years, compared with 22% of those receiving standard treatment. Treatment failure was deemed to occur if measurable virus appeared in the blood or if the child had symptoms of HIV-related illness.

“Our findings provide strong evidence for the global rollout of dolutegravir for children with HIV,” said Diana Gibb, MD, also from the MRC clinical trials unit at UCL, principal investigator of the trial and one of the senior authors of the paper.

“Medical treatments for children often lag woefully behind those of adults because of the separate formulations and studies that are needed,” she added. “With the evidence from ODYSSEY which used simplified dosing of both adult and baby pills, this treatment gap has been reduced and we hope that countries can quickly scale up access to children globally.”
 

Simplified dosing

“Simplifying the dosing is crucial,” concurred Cissy Kityo Mutuluuza, MD, from the Joint Clinical Research Centre in Uganda, the country enrolling most children in the trial. “Older children being able to take the same tablets as adults immediately opens access to dolutegravir for the majority of children living with HIV. It greatly simplifies procurement for national health systems in low- and middle-income countries, and lowers costs.”

Evidence from adults shows dolutegravir has a high genetic barrier to resistance, meaning viruses are less likely to become resistant to it over time. This was confirmed in the ODYSSEY trial, with much less resistance occurring among children and adolescents on dolutegravir-based treatment. In addition, past studies of the drug have shown that it may be associated with weight gain in adults, but the findings were reassuring for children. Those given dolutegravir gained on average 1 kg more and grew 1 cm higher over the study period, indicating better growth rather than abnormal weight gain.

Early findings from the trial have informed new guidance by the World Health Organization, recommending the use of dolutegravir for children.

The study was sponsored by the Penta Foundation, an international independent research network, and funded by specialist pharmaceutical company ViiV Healthcare.

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

A global study led by researchers at University College London, published Dec. 30, 2021, in the New England Journal of Medicine, found that a regimen based on a once-a-day small dolutegravir tablet was more effective at suppressing HIV than standard treatments. Dolutegravir suppresses HIV by inhibiting integrase, an enzyme that the virus needs to replicate.

The pill-based regimen, which researchers described as easier to take than standard treatment, reduced the chances of treatment failure among children aged 3-18 years by about 40%, compared with other treatments. Dolutegravir is already used for the suppression of HIV in adults.

“About 1.8 million children live with HIV but they have had limited treatment options, with medicines that taste unpalatable, that need to be taken twice a day, or that come in large pills that are difficult to swallow” said lead author Anna Turkova, MD, from the MRC clinical trials unit at UCL. “Dolutegravir is given in small tablets usually once a day and the baby pills can be dispersed in water, meaning it’s a lot easier for young children to take. This is important in encouraging uptake of the treatment and adherence to it over many years.

“Sadly, only about half of children living with HIV are currently receiving treatment, and those who are not treated face high risks of impaired immunity and worsening health.”
 

Study details

The randomized controlled trial, called ODYSSEY, involved more than 700 children from 29 clinical centers located in Africa, Europe, and Asia. The children were given either dolutegravir or standard anti-HIV drugs, and were followed up for at least 2 years.

The study showed that 14% of children receiving dolutegravir experienced treatment failure over 2 years, compared with 22% of those receiving standard treatment. Treatment failure was deemed to occur if measurable virus appeared in the blood or if the child had symptoms of HIV-related illness.

“Our findings provide strong evidence for the global rollout of dolutegravir for children with HIV,” said Diana Gibb, MD, also from the MRC clinical trials unit at UCL, principal investigator of the trial and one of the senior authors of the paper.

“Medical treatments for children often lag woefully behind those of adults because of the separate formulations and studies that are needed,” she added. “With the evidence from ODYSSEY which used simplified dosing of both adult and baby pills, this treatment gap has been reduced and we hope that countries can quickly scale up access to children globally.”
 

Simplified dosing

“Simplifying the dosing is crucial,” concurred Cissy Kityo Mutuluuza, MD, from the Joint Clinical Research Centre in Uganda, the country enrolling most children in the trial. “Older children being able to take the same tablets as adults immediately opens access to dolutegravir for the majority of children living with HIV. It greatly simplifies procurement for national health systems in low- and middle-income countries, and lowers costs.”

Evidence from adults shows dolutegravir has a high genetic barrier to resistance, meaning viruses are less likely to become resistant to it over time. This was confirmed in the ODYSSEY trial, with much less resistance occurring among children and adolescents on dolutegravir-based treatment. In addition, past studies of the drug have shown that it may be associated with weight gain in adults, but the findings were reassuring for children. Those given dolutegravir gained on average 1 kg more and grew 1 cm higher over the study period, indicating better growth rather than abnormal weight gain.

Early findings from the trial have informed new guidance by the World Health Organization, recommending the use of dolutegravir for children.

The study was sponsored by the Penta Foundation, an international independent research network, and funded by specialist pharmaceutical company ViiV Healthcare.

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

A global study led by researchers at University College London, published Dec. 30, 2021, in the New England Journal of Medicine, found that a regimen based on a once-a-day small dolutegravir tablet was more effective at suppressing HIV than standard treatments. Dolutegravir suppresses HIV by inhibiting integrase, an enzyme that the virus needs to replicate.

The pill-based regimen, which researchers described as easier to take than standard treatment, reduced the chances of treatment failure among children aged 3-18 years by about 40%, compared with other treatments. Dolutegravir is already used for the suppression of HIV in adults.

“About 1.8 million children live with HIV but they have had limited treatment options, with medicines that taste unpalatable, that need to be taken twice a day, or that come in large pills that are difficult to swallow” said lead author Anna Turkova, MD, from the MRC clinical trials unit at UCL. “Dolutegravir is given in small tablets usually once a day and the baby pills can be dispersed in water, meaning it’s a lot easier for young children to take. This is important in encouraging uptake of the treatment and adherence to it over many years.

“Sadly, only about half of children living with HIV are currently receiving treatment, and those who are not treated face high risks of impaired immunity and worsening health.”
 

Study details

The randomized controlled trial, called ODYSSEY, involved more than 700 children from 29 clinical centers located in Africa, Europe, and Asia. The children were given either dolutegravir or standard anti-HIV drugs, and were followed up for at least 2 years.

The study showed that 14% of children receiving dolutegravir experienced treatment failure over 2 years, compared with 22% of those receiving standard treatment. Treatment failure was deemed to occur if measurable virus appeared in the blood or if the child had symptoms of HIV-related illness.

“Our findings provide strong evidence for the global rollout of dolutegravir for children with HIV,” said Diana Gibb, MD, also from the MRC clinical trials unit at UCL, principal investigator of the trial and one of the senior authors of the paper.

“Medical treatments for children often lag woefully behind those of adults because of the separate formulations and studies that are needed,” she added. “With the evidence from ODYSSEY which used simplified dosing of both adult and baby pills, this treatment gap has been reduced and we hope that countries can quickly scale up access to children globally.”
 

Simplified dosing

“Simplifying the dosing is crucial,” concurred Cissy Kityo Mutuluuza, MD, from the Joint Clinical Research Centre in Uganda, the country enrolling most children in the trial. “Older children being able to take the same tablets as adults immediately opens access to dolutegravir for the majority of children living with HIV. It greatly simplifies procurement for national health systems in low- and middle-income countries, and lowers costs.”

Evidence from adults shows dolutegravir has a high genetic barrier to resistance, meaning viruses are less likely to become resistant to it over time. This was confirmed in the ODYSSEY trial, with much less resistance occurring among children and adolescents on dolutegravir-based treatment. In addition, past studies of the drug have shown that it may be associated with weight gain in adults, but the findings were reassuring for children. Those given dolutegravir gained on average 1 kg more and grew 1 cm higher over the study period, indicating better growth rather than abnormal weight gain.

Early findings from the trial have informed new guidance by the World Health Organization, recommending the use of dolutegravir for children.

The study was sponsored by the Penta Foundation, an international independent research network, and funded by specialist pharmaceutical company ViiV Healthcare.

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

Older Canadian schoolchildren who spent the most time looking at screens during the COVID-19 pandemic experienced higher levels of anxiety and depression, while their younger counterparts had more conduct problems, researchers have found. However, the study doesn’t definitively prove that screen time is harmful, and an expert challenged the conclusions.

Still, the findings highlight the potential harms of excessive screen time, especially in the context of pandemic-era virtual learning. Clinicians “really need to advocate for policies that would be protective for children to reduce their screen time and social isolation and increase their involvement with school, sports, and academic activities,” Catherine S. Birken, MD, a pediatrician at the University of Toronto and study coauthor said in an interview.

The study appeared Dec. 28, 2021, in the journal JAMA Network Open (doi: 10.1001/jamanetworkopen.2021.40875).

Dr. Birken and colleagues launched the study to examine whether heightened levels of screen time during the pandemic disrupted mental health in kids. In particular, they wanted to break down different types of screen time, such as virtual learning, watching television, and playing video games.

“The bulk of the literature is supportive of a strong relationship between screen time and mental health symptoms like anxiety,” Dr. Birken said.

For the study, the researchers surveyed parents to track the screen time of 2,026 children between May 2020 and April 2021.

In a cohort of 532 younger children (average age, 5.9 years; 52% male; 58% of European ancestry), the researchers linked each extra daily hour of TV or use of digital media to worse behavior, as measured by the Strengths and Difficulties Questionnaire: 0.22 in an adjusted model for children aged 2-4;(95% confidence interval, 0.10-0.35; P < .001) and 0.07 in an adjusted model in those aged 4 and older (95% CI, 0.02-0.11; P = .007).

However, the researchers observed no statistically significant links to more anxiety/depression or hyperactivity/inattention in this group of children.

Among 1,494 older kids (mean age, 11.3; 57% male; 58% of European ancestry), researchers linked greater daily use of TV or digital media to higher levels of depression symptoms in a dose-dependent relationship, Dr. Birken said (1 hour: beta, 0.21; 95% CI, –1.28 to 0.78; 2-3 hours: beta, 1.81; 95% CI, 0.29-3.33; 4-5 hours: beta, 2.80; 95% CI, 1.15-4.44; 6-8 hours: beta, 5.16; 95% CI, 3.32-7.01; 9 hours: beta, 5.42; 95% CI, 3.30-7.54; overall P < .001).

“Similarly, higher TV or digital media time per day was associated with higher levels of anxiety symptoms,” the researchers reported. “TV or digital media time per day was also significantly associated with differences in symptoms of irritability, inattention, and hyperactivity/inattention.”

More time spent learning virtually was associated with higher levels of depression and anxiety in both groups of children, according to the researchers. Whether this finding reflects an effect of screens themselves or because the children most exposed to virtual learning may also have been the most exposed to the stressful disruptiveness of the pandemic is unclear.

The researchers also found “insufficient evidence” to link more virtual learning to irritability, inattention and hyperactivity, inattention, and hyperactivity/impulsivity in adjusted models.

Video chatting did not appear to have a protective effect, Dr. Birken said. The researchers also specifically analyzed children with autism and found no link between more screen time and various mental health/conduct problems.

Is it possible that kids with more anxiety, depression, and isolation simply turn to screens because they’re anxious, depressed, and isolated? Dr. Birken said the researchers adjusted the findings to account for previous mental health problems. And she noted that the study linked more pandemic-era virtual learning to more depression/anxiety. It’s “hard to imagine” how more mental health problems would cause more virtual learning.
 

Bad news or bad stats?

Chris Ferguson, PhD, a professor of psychology at Stetson University. DeLand, Fla., who studies screen time, criticized the study in an interview. “The observed effects are so tiny, it’s impossible to know if they are real or a false-positive artifact common to social science research,” he said. “Ultimately, this study is better evidence about how many scholars are bad at statistics than anything having to do with kids and screens.”

Dr. Ferguson said that the results may be confounded because kids turn to screens to reduce their anxiety. “For the most part, screens were a godsend during COVID-19,” he said. “They helped kids stay inside and gave them something to do while social distancing and allowed them to keep in touch with friends and families. Honestly, what else were we expecting kids to do, stare at the wallpaper?”

Children with depression and anxiety often retreat into screens or books to escape the unpleasantries of real life. “That doesn’t mean the screens or books are the culprits,” he said.

Instead of focusing on screen time, Dr. Ferguson suggested parents consider these factors: “Keeping in mind not every kid is a genius, is your kid doing about as well in school as you’d expect, given their natural ability? Are they getting at least some exercise every day? Are they getting adequate sleep? Are they able to socialize with friends in some context, either in real life or online? Are they happy?”

The study was funded by the Canadian Institutes of Health Research, the Center for Brain & Mental Health at The Hospital for Sick Children, the Ontario Ministry of Health, and the Miner’s Lamp Innovation Fund in Prevention and Early Detection of Severe Mental Illness at the University of Toronto. The study authors reported various financial relationships. Dr. Ferguson reported no relevant financial conflicts of interest.

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

Older Canadian schoolchildren who spent the most time looking at screens during the COVID-19 pandemic experienced higher levels of anxiety and depression, while their younger counterparts had more conduct problems, researchers have found. However, the study doesn’t definitively prove that screen time is harmful, and an expert challenged the conclusions.

Still, the findings highlight the potential harms of excessive screen time, especially in the context of pandemic-era virtual learning. Clinicians “really need to advocate for policies that would be protective for children to reduce their screen time and social isolation and increase their involvement with school, sports, and academic activities,” Catherine S. Birken, MD, a pediatrician at the University of Toronto and study coauthor said in an interview.

The study appeared Dec. 28, 2021, in the journal JAMA Network Open (doi: 10.1001/jamanetworkopen.2021.40875).

Dr. Birken and colleagues launched the study to examine whether heightened levels of screen time during the pandemic disrupted mental health in kids. In particular, they wanted to break down different types of screen time, such as virtual learning, watching television, and playing video games.

“The bulk of the literature is supportive of a strong relationship between screen time and mental health symptoms like anxiety,” Dr. Birken said.

For the study, the researchers surveyed parents to track the screen time of 2,026 children between May 2020 and April 2021.

In a cohort of 532 younger children (average age, 5.9 years; 52% male; 58% of European ancestry), the researchers linked each extra daily hour of TV or use of digital media to worse behavior, as measured by the Strengths and Difficulties Questionnaire: 0.22 in an adjusted model for children aged 2-4;(95% confidence interval, 0.10-0.35; P < .001) and 0.07 in an adjusted model in those aged 4 and older (95% CI, 0.02-0.11; P = .007).

However, the researchers observed no statistically significant links to more anxiety/depression or hyperactivity/inattention in this group of children.

Among 1,494 older kids (mean age, 11.3; 57% male; 58% of European ancestry), researchers linked greater daily use of TV or digital media to higher levels of depression symptoms in a dose-dependent relationship, Dr. Birken said (1 hour: beta, 0.21; 95% CI, –1.28 to 0.78; 2-3 hours: beta, 1.81; 95% CI, 0.29-3.33; 4-5 hours: beta, 2.80; 95% CI, 1.15-4.44; 6-8 hours: beta, 5.16; 95% CI, 3.32-7.01; 9 hours: beta, 5.42; 95% CI, 3.30-7.54; overall P < .001).

“Similarly, higher TV or digital media time per day was associated with higher levels of anxiety symptoms,” the researchers reported. “TV or digital media time per day was also significantly associated with differences in symptoms of irritability, inattention, and hyperactivity/inattention.”

More time spent learning virtually was associated with higher levels of depression and anxiety in both groups of children, according to the researchers. Whether this finding reflects an effect of screens themselves or because the children most exposed to virtual learning may also have been the most exposed to the stressful disruptiveness of the pandemic is unclear.

The researchers also found “insufficient evidence” to link more virtual learning to irritability, inattention and hyperactivity, inattention, and hyperactivity/impulsivity in adjusted models.

Video chatting did not appear to have a protective effect, Dr. Birken said. The researchers also specifically analyzed children with autism and found no link between more screen time and various mental health/conduct problems.

Is it possible that kids with more anxiety, depression, and isolation simply turn to screens because they’re anxious, depressed, and isolated? Dr. Birken said the researchers adjusted the findings to account for previous mental health problems. And she noted that the study linked more pandemic-era virtual learning to more depression/anxiety. It’s “hard to imagine” how more mental health problems would cause more virtual learning.
 

Bad news or bad stats?

Chris Ferguson, PhD, a professor of psychology at Stetson University. DeLand, Fla., who studies screen time, criticized the study in an interview. “The observed effects are so tiny, it’s impossible to know if they are real or a false-positive artifact common to social science research,” he said. “Ultimately, this study is better evidence about how many scholars are bad at statistics than anything having to do with kids and screens.”

Dr. Ferguson said that the results may be confounded because kids turn to screens to reduce their anxiety. “For the most part, screens were a godsend during COVID-19,” he said. “They helped kids stay inside and gave them something to do while social distancing and allowed them to keep in touch with friends and families. Honestly, what else were we expecting kids to do, stare at the wallpaper?”

Children with depression and anxiety often retreat into screens or books to escape the unpleasantries of real life. “That doesn’t mean the screens or books are the culprits,” he said.

Instead of focusing on screen time, Dr. Ferguson suggested parents consider these factors: “Keeping in mind not every kid is a genius, is your kid doing about as well in school as you’d expect, given their natural ability? Are they getting at least some exercise every day? Are they getting adequate sleep? Are they able to socialize with friends in some context, either in real life or online? Are they happy?”

The study was funded by the Canadian Institutes of Health Research, the Center for Brain & Mental Health at The Hospital for Sick Children, the Ontario Ministry of Health, and the Miner’s Lamp Innovation Fund in Prevention and Early Detection of Severe Mental Illness at the University of Toronto. The study authors reported various financial relationships. Dr. Ferguson reported no relevant financial conflicts of interest.

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

Older Canadian schoolchildren who spent the most time looking at screens during the COVID-19 pandemic experienced higher levels of anxiety and depression, while their younger counterparts had more conduct problems, researchers have found. However, the study doesn’t definitively prove that screen time is harmful, and an expert challenged the conclusions.

Still, the findings highlight the potential harms of excessive screen time, especially in the context of pandemic-era virtual learning. Clinicians “really need to advocate for policies that would be protective for children to reduce their screen time and social isolation and increase their involvement with school, sports, and academic activities,” Catherine S. Birken, MD, a pediatrician at the University of Toronto and study coauthor said in an interview.

The study appeared Dec. 28, 2021, in the journal JAMA Network Open (doi: 10.1001/jamanetworkopen.2021.40875).

Dr. Birken and colleagues launched the study to examine whether heightened levels of screen time during the pandemic disrupted mental health in kids. In particular, they wanted to break down different types of screen time, such as virtual learning, watching television, and playing video games.

“The bulk of the literature is supportive of a strong relationship between screen time and mental health symptoms like anxiety,” Dr. Birken said.

For the study, the researchers surveyed parents to track the screen time of 2,026 children between May 2020 and April 2021.

In a cohort of 532 younger children (average age, 5.9 years; 52% male; 58% of European ancestry), the researchers linked each extra daily hour of TV or use of digital media to worse behavior, as measured by the Strengths and Difficulties Questionnaire: 0.22 in an adjusted model for children aged 2-4;(95% confidence interval, 0.10-0.35; P < .001) and 0.07 in an adjusted model in those aged 4 and older (95% CI, 0.02-0.11; P = .007).

However, the researchers observed no statistically significant links to more anxiety/depression or hyperactivity/inattention in this group of children.

Among 1,494 older kids (mean age, 11.3; 57% male; 58% of European ancestry), researchers linked greater daily use of TV or digital media to higher levels of depression symptoms in a dose-dependent relationship, Dr. Birken said (1 hour: beta, 0.21; 95% CI, –1.28 to 0.78; 2-3 hours: beta, 1.81; 95% CI, 0.29-3.33; 4-5 hours: beta, 2.80; 95% CI, 1.15-4.44; 6-8 hours: beta, 5.16; 95% CI, 3.32-7.01; 9 hours: beta, 5.42; 95% CI, 3.30-7.54; overall P < .001).

“Similarly, higher TV or digital media time per day was associated with higher levels of anxiety symptoms,” the researchers reported. “TV or digital media time per day was also significantly associated with differences in symptoms of irritability, inattention, and hyperactivity/inattention.”

More time spent learning virtually was associated with higher levels of depression and anxiety in both groups of children, according to the researchers. Whether this finding reflects an effect of screens themselves or because the children most exposed to virtual learning may also have been the most exposed to the stressful disruptiveness of the pandemic is unclear.

The researchers also found “insufficient evidence” to link more virtual learning to irritability, inattention and hyperactivity, inattention, and hyperactivity/impulsivity in adjusted models.

Video chatting did not appear to have a protective effect, Dr. Birken said. The researchers also specifically analyzed children with autism and found no link between more screen time and various mental health/conduct problems.

Is it possible that kids with more anxiety, depression, and isolation simply turn to screens because they’re anxious, depressed, and isolated? Dr. Birken said the researchers adjusted the findings to account for previous mental health problems. And she noted that the study linked more pandemic-era virtual learning to more depression/anxiety. It’s “hard to imagine” how more mental health problems would cause more virtual learning.
 

Bad news or bad stats?

Chris Ferguson, PhD, a professor of psychology at Stetson University. DeLand, Fla., who studies screen time, criticized the study in an interview. “The observed effects are so tiny, it’s impossible to know if they are real or a false-positive artifact common to social science research,” he said. “Ultimately, this study is better evidence about how many scholars are bad at statistics than anything having to do with kids and screens.”

Dr. Ferguson said that the results may be confounded because kids turn to screens to reduce their anxiety. “For the most part, screens were a godsend during COVID-19,” he said. “They helped kids stay inside and gave them something to do while social distancing and allowed them to keep in touch with friends and families. Honestly, what else were we expecting kids to do, stare at the wallpaper?”

Children with depression and anxiety often retreat into screens or books to escape the unpleasantries of real life. “That doesn’t mean the screens or books are the culprits,” he said.

Instead of focusing on screen time, Dr. Ferguson suggested parents consider these factors: “Keeping in mind not every kid is a genius, is your kid doing about as well in school as you’d expect, given their natural ability? Are they getting at least some exercise every day? Are they getting adequate sleep? Are they able to socialize with friends in some context, either in real life or online? Are they happy?”

The study was funded by the Canadian Institutes of Health Research, the Center for Brain & Mental Health at The Hospital for Sick Children, the Ontario Ministry of Health, and the Miner’s Lamp Innovation Fund in Prevention and Early Detection of Severe Mental Illness at the University of Toronto. The study authors reported various financial relationships. Dr. Ferguson reported no relevant financial conflicts of interest.

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

Federal officials will allow some flexibility in meeting new requirements on covering the costs of clinical trials for people enrolled in Medicaid, seeking to accommodate states where legislatures will not meet in time to make needed changes in rules.

Congress in 2020 ordered U.S. states to have their Medicaid programs cover expenses related to participation in certain clinical trials, a move that was hailed by the American Society of Clinical Oncology (ASCO) and other groups as a boost to trials as well as to patients with serious illness who have lower incomes.

The mandate went into effect on Jan. 1, but the Centers for Medicare & Medicaid Services will allow accommodations in terms of implementation time for states that have not yet been able to make needed legislative changes, Daniel Tsai, deputy administrator and director of the Center for Medicaid and CHIP Services, wrote in a Dec. 7 letter. Mr. Tsai’s letter doesn’t mention specific states. The CMS did not immediately respond to a request seeking information on the states expected to apply for waivers.

Medicaid has in recent years been a rare large U.S. insurance program that does not cover the costs of clinical trials. The Affordable Care Act of 2010 mandated this coverage for people in private insurance plans. The federal government in 2000 decided that Medicare would do so.

‘A hidden opportunity’

A perspective article last May in the New England Journal of Medicine referred to the new Medicaid mandate on clinical trials as a “hidden opportunity,” referring to its genesis as an add-on in a massive federal spending package enacted in December 2020.

In the article, Samuel U. Takvorian, MD, MSHP, of the University of Pennsylvania, Philadelphia, and coauthors noted that rates of participation in clinical trials remain low for racial and ethnic minority groups, due in part to the lack of Medicaid coverage.

“For example, non-Hispanic White patients are nearly twice as likely as Black patients and three times as likely as Hispanic patients to enroll in cancer clinical trials – a gap that has widened over time,” Dr. Takvorian and coauthors wrote. “Inequities in enrollment have also manifested during the COVID-19 pandemic, which has disproportionately affected non-White patients, without their commensurate representation in trials of COVID-19 therapeutics.”

In October, researchers from the Arthur G. James Cancer Hospital and Ohio State University, Columbus, published results of a retrospective study of patients with stage I-IV pancreatic cancer that also found inequities in enrollment. Mariam F. Eskander, MD, MPH, and coauthors reported what they found by examining records for 1,127 patients (0.4%) enrolled in clinical trials and 301,340 (99.6%) who did not enroll. They found that enrollment in trials increased over the study period, but not for Black patients or patients on Medicaid.

In an interview, Dr. Eskander said the new Medicaid policy will remove a major obstacle to participation in clinical trials. An oncologist, Dr. Eskander said she is looking forward to being able to help more of her patients get access to experimental medicines and treatments.

But that may not be enough to draw more people with low incomes into these studies, said Dr. Eskander, who is now at Rutgers Cancer Institute of New Jersey in New Brunswick. She urges greater use of patient navigators to help people on Medicaid understand the resources available to them, as well as broad use of Medicaid’s nonemergency medical transportation (NEMT) benefit.

“Some patients will be offered clinical trial enrollment and some will accept, but I really worry about the challenges low-income people face with things like transportation and getting time off work,” she said.

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

Federal officials will allow some flexibility in meeting new requirements on covering the costs of clinical trials for people enrolled in Medicaid, seeking to accommodate states where legislatures will not meet in time to make needed changes in rules.

Congress in 2020 ordered U.S. states to have their Medicaid programs cover expenses related to participation in certain clinical trials, a move that was hailed by the American Society of Clinical Oncology (ASCO) and other groups as a boost to trials as well as to patients with serious illness who have lower incomes.

The mandate went into effect on Jan. 1, but the Centers for Medicare & Medicaid Services will allow accommodations in terms of implementation time for states that have not yet been able to make needed legislative changes, Daniel Tsai, deputy administrator and director of the Center for Medicaid and CHIP Services, wrote in a Dec. 7 letter. Mr. Tsai’s letter doesn’t mention specific states. The CMS did not immediately respond to a request seeking information on the states expected to apply for waivers.

Medicaid has in recent years been a rare large U.S. insurance program that does not cover the costs of clinical trials. The Affordable Care Act of 2010 mandated this coverage for people in private insurance plans. The federal government in 2000 decided that Medicare would do so.

‘A hidden opportunity’

A perspective article last May in the New England Journal of Medicine referred to the new Medicaid mandate on clinical trials as a “hidden opportunity,” referring to its genesis as an add-on in a massive federal spending package enacted in December 2020.

In the article, Samuel U. Takvorian, MD, MSHP, of the University of Pennsylvania, Philadelphia, and coauthors noted that rates of participation in clinical trials remain low for racial and ethnic minority groups, due in part to the lack of Medicaid coverage.

“For example, non-Hispanic White patients are nearly twice as likely as Black patients and three times as likely as Hispanic patients to enroll in cancer clinical trials – a gap that has widened over time,” Dr. Takvorian and coauthors wrote. “Inequities in enrollment have also manifested during the COVID-19 pandemic, which has disproportionately affected non-White patients, without their commensurate representation in trials of COVID-19 therapeutics.”

In October, researchers from the Arthur G. James Cancer Hospital and Ohio State University, Columbus, published results of a retrospective study of patients with stage I-IV pancreatic cancer that also found inequities in enrollment. Mariam F. Eskander, MD, MPH, and coauthors reported what they found by examining records for 1,127 patients (0.4%) enrolled in clinical trials and 301,340 (99.6%) who did not enroll. They found that enrollment in trials increased over the study period, but not for Black patients or patients on Medicaid.

In an interview, Dr. Eskander said the new Medicaid policy will remove a major obstacle to participation in clinical trials. An oncologist, Dr. Eskander said she is looking forward to being able to help more of her patients get access to experimental medicines and treatments.

But that may not be enough to draw more people with low incomes into these studies, said Dr. Eskander, who is now at Rutgers Cancer Institute of New Jersey in New Brunswick. She urges greater use of patient navigators to help people on Medicaid understand the resources available to them, as well as broad use of Medicaid’s nonemergency medical transportation (NEMT) benefit.

“Some patients will be offered clinical trial enrollment and some will accept, but I really worry about the challenges low-income people face with things like transportation and getting time off work,” she said.

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

Federal officials will allow some flexibility in meeting new requirements on covering the costs of clinical trials for people enrolled in Medicaid, seeking to accommodate states where legislatures will not meet in time to make needed changes in rules.

Congress in 2020 ordered U.S. states to have their Medicaid programs cover expenses related to participation in certain clinical trials, a move that was hailed by the American Society of Clinical Oncology (ASCO) and other groups as a boost to trials as well as to patients with serious illness who have lower incomes.

The mandate went into effect on Jan. 1, but the Centers for Medicare & Medicaid Services will allow accommodations in terms of implementation time for states that have not yet been able to make needed legislative changes, Daniel Tsai, deputy administrator and director of the Center for Medicaid and CHIP Services, wrote in a Dec. 7 letter. Mr. Tsai’s letter doesn’t mention specific states. The CMS did not immediately respond to a request seeking information on the states expected to apply for waivers.

Medicaid has in recent years been a rare large U.S. insurance program that does not cover the costs of clinical trials. The Affordable Care Act of 2010 mandated this coverage for people in private insurance plans. The federal government in 2000 decided that Medicare would do so.

‘A hidden opportunity’

A perspective article last May in the New England Journal of Medicine referred to the new Medicaid mandate on clinical trials as a “hidden opportunity,” referring to its genesis as an add-on in a massive federal spending package enacted in December 2020.

In the article, Samuel U. Takvorian, MD, MSHP, of the University of Pennsylvania, Philadelphia, and coauthors noted that rates of participation in clinical trials remain low for racial and ethnic minority groups, due in part to the lack of Medicaid coverage.

“For example, non-Hispanic White patients are nearly twice as likely as Black patients and three times as likely as Hispanic patients to enroll in cancer clinical trials – a gap that has widened over time,” Dr. Takvorian and coauthors wrote. “Inequities in enrollment have also manifested during the COVID-19 pandemic, which has disproportionately affected non-White patients, without their commensurate representation in trials of COVID-19 therapeutics.”

In October, researchers from the Arthur G. James Cancer Hospital and Ohio State University, Columbus, published results of a retrospective study of patients with stage I-IV pancreatic cancer that also found inequities in enrollment. Mariam F. Eskander, MD, MPH, and coauthors reported what they found by examining records for 1,127 patients (0.4%) enrolled in clinical trials and 301,340 (99.6%) who did not enroll. They found that enrollment in trials increased over the study period, but not for Black patients or patients on Medicaid.

In an interview, Dr. Eskander said the new Medicaid policy will remove a major obstacle to participation in clinical trials. An oncologist, Dr. Eskander said she is looking forward to being able to help more of her patients get access to experimental medicines and treatments.

But that may not be enough to draw more people with low incomes into these studies, said Dr. Eskander, who is now at Rutgers Cancer Institute of New Jersey in New Brunswick. She urges greater use of patient navigators to help people on Medicaid understand the resources available to them, as well as broad use of Medicaid’s nonemergency medical transportation (NEMT) benefit.

“Some patients will be offered clinical trial enrollment and some will accept, but I really worry about the challenges low-income people face with things like transportation and getting time off work,” she said.

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

It was a freezing December day, and two young brothers were playing outside near a swimming pool when the younger boy, a 3-year-old toddler, fell into the water.

The 7-year-old immediately jumped into the pool to save his brother and was able to pull the toddler to the pool steps where the boy’s head was above water. But the icy temperatures overcame the older brother and he drifted underwater.

“Despite being at the forefront of medicine, what we don’t understand often exceeds what we do understand,” said Harley Rotbart, MD, author of “Miracles We Have Seen” (Health Communications: Deerfield Beach, Fla., 2016).

Paramedics arrived to find both boys unconscious and rushed them to the Children’s Hospital of Philadelphia. The younger boy regained consciousness in the ICU and recovered. The 7-year-old, however, was unresponsive and remained in a coma, said Dr. Rotbart a pediatrician and author based in Denver.

Family members stayed at the boy’s bedside and prayed. But after several weeks, the child’s condition remained unchanged. His parents began to discuss ending life support and organ donation. Then late one night, as Dr. Rotbart sat reading to the unconscious patient, the little boy squeezed his hand. In disbelief, Dr. Rotbart told all of his colleagues about the squeeze the next morning. Everyone attributed the movement to an involuntary muscle spasm, he said. After all, every test and scan showed the boy had no brain function.

But later that day, the child grasped another staff member’s hand. Shortly after that, he squeezed in response to a command. Dr. Rotbart and his staff were stunned, but cautious about feeling too much hope. 

Days later, the child opened his eyes. Then, he smiled. His parents were overjoyed. 

“When he walked out of the hospital more than 2 months after the near-drowning and his heroic rescue of his little brother, we all cheered and cried,” Dr. Rotbart wrote in his book. “We cried many times in the weeks preceding, and I still cry whenever I recall this story.”

The experience, which happened years ago when Dr. Rotbart was a trainee, has stayed with the pediatrician his entire career. 

“His awakening was seemingly impossible – and then it happened,” Dr. Rotbart said. “Despite being at the forefront of medicine and science, what we don’t understand often exceeds what we do understand. And even when we think we understand, we are frequently proven wrong.”

For many, Dr. Rotbart’s experience raises questions about the existence of medical miracles. Although the term can have different definitions, a “medical miracle” generally refers to an unexpected recovery despite a dire prognosis. Frequently, the phrase has a religious connotation and is used to describe a supernatural or paranormal healing.

Do physicians believe in medical miracles? The answers are diverse.

“I have no doubt that extraordinary outcomes happen where patients who are overwhelmingly expected not to survive, do,” says Eric Beam, MD, a hospitalist based in San Diego. “That’s one of the reasons we choose our words very carefully in our conversations with patients and their families and remember that nothing is 0%, and nothing is 100%. But doctors tend to treat situations that are 99.9% as absolute. I don’t think you can practice medicine with the hope or expectation that every case you see has the potential to beat the odds – or be a medical miracle.”
 

Disappearing cancer hailed as ‘miracle’

In 2003, physicians projected that Joseph Rick, 40, had just a few months to live. His mucosal melanoma had spread throughout his body, progressing even after several surgeries, radiation therapy, and a combination of chemotherapy agents, recalled Antoni Ribas, MD, PhD, an oncologist and director of the tumor immunology program at Jonsson Comprehensive Cancer Center in Los Angeles.

Mr. Rick’s melanoma had spread to his intestines with traces on his stomach and bladder. Tumors were present on his liver, lungs, and pancreas. Rick bought a grave and prepared for the worst, he recounted in a Cancer Research Institute video. But his fate took a turn when he enrolled in an experimental drug trial in December 2003. The phase 1 trial was for a new immune modulating antibody, called an anti–CTLA-4 antibody, said Dr. Ribas, who conducted the trial. 

Over the next few weeks and months, all areas of Rick’s melanoma metastases disappeared. By 2009, he was in remission. He has lived the rest of his life with no evidence of melanoma, according to Dr. Ribas.

Mr. Rick’s case has been referenced throughout literature and news stories as a “medical miracle” and a “cancer miracle.”

Does Dr. Ribas think the case was a medical miracle?

“The response in Joseph Rick was what happened in 10%-15% of patients who received anti-CTLA-4 therapy,” Dr. Ribas said. “These were not miracles. These patients responded because their immune system trying to attack the cancer had been stuck at the CTLA-4 checkpoint. Blocking this checkpoint allowed their immune system to proceed to attack and kill cancer cells anywhere in the body.”

The scientific basis of this therapy was work by University of Texas MD Anderson Cancer Center immunologist James Allison, PhD, that had been done 5 years earlier in mouse models, where giving an anti–CTLA-4 antibody to mice allowed them to reject several implanted cancers, Dr. Ribas explained. Dr. Allison received the 2018 Nobel Prize in Physiology or Medicine for this work, subsequently opening the door for what we now call “immune checkpoint blockade therapy for cancer.” Dr. Ribas added.

“We tend to call miracles good things that we do not understand how they happened,” Dr. Ribas said. “From the human observation perspective, there have been plenty of medical miracles. However, each one has a specific biological mechanism that led to improvement in a patient. In cancer treatment, early studies using the immune system resulted in occasional patients having tumor responses and long-term benefits.

“With the increased understanding of how the immune system interacts with cancers, which is based on remarkable progress in understanding how the immune system works generated over the past several decades, these ‘miracles’ become specific mechanisms leading to response to cancer, which can then be replicated in other patients.”
 

Patient defies odds after 45 minutes without heartbeat

Florida ob.gyn. Michael Fleischer, MD, had just performed a routine repeat cesarean birth, delivering a healthy baby girl. His patient, Ruby, had a history of high blood pressure but medication taken during the pregnancy had kept her levels stabilized.

In the waiting room, Dr. Fleischer informed Ruby’s large family of the good news. He was planning to head home early that day when he heard his name being called over the hospital’s loudspeaker. Ruby had stopped breathing.

“The anesthesiologist was with her and had immediately intubated her,” Dr. Fleischer said. “We checked to make sure there was no problems or bleeding from the C-section, but everything was completely fine. However, we couldn’t keep her blood pressure stable.”

Dr. Fleischer suspected the respiratory arrest was caused by either an amniotic fluid embolism or a pulmonary embolism. Intubation continued and physicians gave Ruby medication to stabilize her blood pressure. Then suddenly, Ruby’s heart stopped.

Dr. Fleischer and other doctors began compressions, which they continued for 30 minutes. They shocked Ruby with defibrillator paddles multiple times, but there was no change.

“I was already thinking, this is hopeless, there’s nothing we can do,” he said. “The writing is on the wall. She’s going to die.”

Dr. Fleischer spoke to Ruby’s family and explained the tragic turn of events. Relatives were distraught and tearfully visited Ruby to say their goodbyes. They prayed and cried. Eventually, physicians ceased compressions. Ruby had gone 45 minutes without a pulse. The EKG was still showing some irregularity, FDr. leischer said, but no rhythm. Physicians kept Ruby intubated as they waited for the background electrical activity to fade. As they watched the screen in anguish, there was suddenly a blip on the heart rate monitor. Then another and another. Within seconds, Ruby’s heart went back into sinus rhythm.

“We were in disbelief,” Dr. Fleischer said. “We did some tests and put her in the ICU, and she was fine. Usually, after doing compressions on anyone, you’d have bruising or broken ribs. She had nothing. She just woke up and said: ‘What am I doing here? Let me go see my baby.’ ”

Ruby fully recovered, and 3 days later, she went home with her newborn.

While the recovery was unbelievable, Dr. Fleischer stopped short of calling it a medical miracle. There were scientific contributors to her survival: she was immediately intubated when she stopped breathing and compressions were started as soon as her heart stopped.

However, Dr. Fleischer said the fact that lifesaving measures had ended, and Ruby revived on her own was indeed, miraculous.

“It wasn’t like we were doing compressions and brought her back,” he said. “I can scientifically explain things in my mind, except for that. That when we finally stopped and took our hands off her, that’s when something changed. That’s when she came back.”
 

How do ‘medical miracles’ impact physicians?

When Dr. Rotbart was writing his book, which includes physician essays from across the world, he was struck by how many of the events happened decades earlier.

“This is another testament to the powerful impact these experiences have on those witnessing them,” he said. “In many cases, physicians describing events occurring years ago noted that those early memories served to give them hope as they encountered new, seemingly hopeless cases in subsequent years. Some contributors wrote that the ‘miracle experience’ actually directed them in their choice of specialty and has influenced much of their professional decision-making throughout their careers. Others draw on those miraculous moments at times when they themselves feel hopeless in the face of adversity and tragedy.”

Dr. Fleischer said that, although Ruby’s story has stayed with him, his mindset or practice style didn’t necessarily change after the experience.

“I’m not sure if it’s affected me because I haven’t been in that situation again,” he said. “I’m in the middle. I would never rule out anything, but I’m not going to base how I practice on the hope for a medical miracle.”

In a recent opinion piece for the New York Times, pulmonary and critical care physician, Daniela Lamas, MD, wrote about the sometimes negative effects of miracle cases on physicians. Such experiences for instance, can lead to a greater drive to beat the odds in future cases, which can sometimes lead to false hope, protracted critical care admissions, and futile procedures. 

“After all, in most cases in the ICU, our initial prognoses are correct,” she wrote. “So there’s a risk to standing at the bedside, thinking about that one patient who made it home despite our predictions. We can give that experience too much weight in influencing our decisions and recommendations.”

Dr. Beam said unexpected outcomes – particularly in the age of COVID-19 – can certainly make physicians think differently about life-sustaining measures and when to discuss end-of-life care with family members. In his own practice, Dr. Beam has encountered unexpected COVID recoveries. Now, he generally gives extremely ill COVID patients a little more time to see if their bodies recover.

“It remains true that people who are really sick with COVID, who are on ventilated or who are requiring a lot of up respiratory support, they don’t do well on average,” he said. “But it is [also] true that there are a handful of people who get to that point and do come back to 80% or 90% of where they were. It makes you think twice.”
 

What to do when parents hope for a miracle

In his palliative care practice, Nashville, Tenn., surgeon Myrick Shinall Jr., MD, PhD, regularly encounters families and patients who wish for a medical miracle. 

“It happens pretty often from a palliative care perspective,” he said. “What I have experienced the most is a patient with a severe brain injury who we don’t believe is recoverable. The medical team is discussing with the family that it is probably time to discontinue the ventilator. In those situations, families will often talk about wanting us to continue on [our life-sustaining efforts] in the hopes that a miracle will happen.”

Dr. Shinall and Trevor Bibler, PhD, recently authored two articles about best practices for responding to patients who hope for a miracle. The first one, published in the American Journal of Bioethics, is directed toward bioethicists; the second article, in the Journal of Pain and Symptom Management, targets clinicians.

A primary takeaway from the papers is that health professionals should recognize that hope for a miracle may mean different things to different people, said Dr. Bibler, an ethicist and assistant professor at Baylor College of Medicine, Houston. Some patients may have an innocuous hope for a miracle without a religious connotation, whereas others may have a firm conviction in their idea of God, their spirituality, and a concrete vision of the miracle.

“To hear that a family or patient is hoping for a miracle, one shouldn’t assume they already know what the patient or the family might mean by that,” Dr. Bibler said. “If a patient were to say, ‘I hope for a miracle,’ you might ask: ‘What do you mean by a miracle?’ Health professionals should feel empowered to ask that question.”

Health care professionals should explore a patient’s hope for a miracle, be nonjudgmental, ask clarifying questions, restate what the patient has said, and delve into the patient’s world view on death and dying, according to Dr. Bibler’s analyses. In some cases, it may be helpful to include a chaplain or the presence of a theology outsider in discussions. 

When his patients and their families raise the subject of miracles, Dr. Shinall said he inquires what a miracle would look like in their opinion and tries to gauge how much of the assertion is a general hope compared with a firm belief. 

“I try to work with them to make sure they understand doctors’ decisions and recommendations are based on what we know and can predict from our medical experience,” he said. “And that there’s nothing we’re going to do to prevent a miracle from happening, but that that can’t be our medical plan – to wait for a miracle.”

Despite the many patients and families Dr. Shinall has encountered who hope for a miracle, he has never experienced a case that he would describe as a medical miracle, he said. 

Dr. Rotbart believes all physicians struggle with finding balance in how far to push in hope of a miracle and when to let go.

“Miracles, whether they happen to us, or we hear of them from colleagues or we read about them, should humble us as physicians,” he said. “I have come to believe that what we don’t know or don’t understand about medicine, medical miracles, or life in general, isn‘t necessarily cause for fear, and can even be reason for hope.

“Medicine has come a long way since Hippocrates’ theory of The Four Humors and The Four Temperaments, yet we still have much to learn about the workings of the human body. As physicians, we should take comfort in how much we don’t know because that allows us to share hope with our patients and, occasionally, makes medical miracles possible.”

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

It was a freezing December day, and two young brothers were playing outside near a swimming pool when the younger boy, a 3-year-old toddler, fell into the water.

The 7-year-old immediately jumped into the pool to save his brother and was able to pull the toddler to the pool steps where the boy’s head was above water. But the icy temperatures overcame the older brother and he drifted underwater.

“Despite being at the forefront of medicine, what we don’t understand often exceeds what we do understand,” said Harley Rotbart, MD, author of “Miracles We Have Seen” (Health Communications: Deerfield Beach, Fla., 2016).

Paramedics arrived to find both boys unconscious and rushed them to the Children’s Hospital of Philadelphia. The younger boy regained consciousness in the ICU and recovered. The 7-year-old, however, was unresponsive and remained in a coma, said Dr. Rotbart a pediatrician and author based in Denver.

Family members stayed at the boy’s bedside and prayed. But after several weeks, the child’s condition remained unchanged. His parents began to discuss ending life support and organ donation. Then late one night, as Dr. Rotbart sat reading to the unconscious patient, the little boy squeezed his hand. In disbelief, Dr. Rotbart told all of his colleagues about the squeeze the next morning. Everyone attributed the movement to an involuntary muscle spasm, he said. After all, every test and scan showed the boy had no brain function.

But later that day, the child grasped another staff member’s hand. Shortly after that, he squeezed in response to a command. Dr. Rotbart and his staff were stunned, but cautious about feeling too much hope. 

Days later, the child opened his eyes. Then, he smiled. His parents were overjoyed. 

“When he walked out of the hospital more than 2 months after the near-drowning and his heroic rescue of his little brother, we all cheered and cried,” Dr. Rotbart wrote in his book. “We cried many times in the weeks preceding, and I still cry whenever I recall this story.”

The experience, which happened years ago when Dr. Rotbart was a trainee, has stayed with the pediatrician his entire career. 

“His awakening was seemingly impossible – and then it happened,” Dr. Rotbart said. “Despite being at the forefront of medicine and science, what we don’t understand often exceeds what we do understand. And even when we think we understand, we are frequently proven wrong.”

For many, Dr. Rotbart’s experience raises questions about the existence of medical miracles. Although the term can have different definitions, a “medical miracle” generally refers to an unexpected recovery despite a dire prognosis. Frequently, the phrase has a religious connotation and is used to describe a supernatural or paranormal healing.

Do physicians believe in medical miracles? The answers are diverse.

“I have no doubt that extraordinary outcomes happen where patients who are overwhelmingly expected not to survive, do,” says Eric Beam, MD, a hospitalist based in San Diego. “That’s one of the reasons we choose our words very carefully in our conversations with patients and their families and remember that nothing is 0%, and nothing is 100%. But doctors tend to treat situations that are 99.9% as absolute. I don’t think you can practice medicine with the hope or expectation that every case you see has the potential to beat the odds – or be a medical miracle.”
 

Disappearing cancer hailed as ‘miracle’

In 2003, physicians projected that Joseph Rick, 40, had just a few months to live. His mucosal melanoma had spread throughout his body, progressing even after several surgeries, radiation therapy, and a combination of chemotherapy agents, recalled Antoni Ribas, MD, PhD, an oncologist and director of the tumor immunology program at Jonsson Comprehensive Cancer Center in Los Angeles.

Mr. Rick’s melanoma had spread to his intestines with traces on his stomach and bladder. Tumors were present on his liver, lungs, and pancreas. Rick bought a grave and prepared for the worst, he recounted in a Cancer Research Institute video. But his fate took a turn when he enrolled in an experimental drug trial in December 2003. The phase 1 trial was for a new immune modulating antibody, called an anti–CTLA-4 antibody, said Dr. Ribas, who conducted the trial. 

Over the next few weeks and months, all areas of Rick’s melanoma metastases disappeared. By 2009, he was in remission. He has lived the rest of his life with no evidence of melanoma, according to Dr. Ribas.

Mr. Rick’s case has been referenced throughout literature and news stories as a “medical miracle” and a “cancer miracle.”

Does Dr. Ribas think the case was a medical miracle?

“The response in Joseph Rick was what happened in 10%-15% of patients who received anti-CTLA-4 therapy,” Dr. Ribas said. “These were not miracles. These patients responded because their immune system trying to attack the cancer had been stuck at the CTLA-4 checkpoint. Blocking this checkpoint allowed their immune system to proceed to attack and kill cancer cells anywhere in the body.”

The scientific basis of this therapy was work by University of Texas MD Anderson Cancer Center immunologist James Allison, PhD, that had been done 5 years earlier in mouse models, where giving an anti–CTLA-4 antibody to mice allowed them to reject several implanted cancers, Dr. Ribas explained. Dr. Allison received the 2018 Nobel Prize in Physiology or Medicine for this work, subsequently opening the door for what we now call “immune checkpoint blockade therapy for cancer.” Dr. Ribas added.

“We tend to call miracles good things that we do not understand how they happened,” Dr. Ribas said. “From the human observation perspective, there have been plenty of medical miracles. However, each one has a specific biological mechanism that led to improvement in a patient. In cancer treatment, early studies using the immune system resulted in occasional patients having tumor responses and long-term benefits.

“With the increased understanding of how the immune system interacts with cancers, which is based on remarkable progress in understanding how the immune system works generated over the past several decades, these ‘miracles’ become specific mechanisms leading to response to cancer, which can then be replicated in other patients.”
 

Patient defies odds after 45 minutes without heartbeat

Florida ob.gyn. Michael Fleischer, MD, had just performed a routine repeat cesarean birth, delivering a healthy baby girl. His patient, Ruby, had a history of high blood pressure but medication taken during the pregnancy had kept her levels stabilized.

In the waiting room, Dr. Fleischer informed Ruby’s large family of the good news. He was planning to head home early that day when he heard his name being called over the hospital’s loudspeaker. Ruby had stopped breathing.

“The anesthesiologist was with her and had immediately intubated her,” Dr. Fleischer said. “We checked to make sure there was no problems or bleeding from the C-section, but everything was completely fine. However, we couldn’t keep her blood pressure stable.”

Dr. Fleischer suspected the respiratory arrest was caused by either an amniotic fluid embolism or a pulmonary embolism. Intubation continued and physicians gave Ruby medication to stabilize her blood pressure. Then suddenly, Ruby’s heart stopped.

Dr. Fleischer and other doctors began compressions, which they continued for 30 minutes. They shocked Ruby with defibrillator paddles multiple times, but there was no change.

“I was already thinking, this is hopeless, there’s nothing we can do,” he said. “The writing is on the wall. She’s going to die.”

Dr. Fleischer spoke to Ruby’s family and explained the tragic turn of events. Relatives were distraught and tearfully visited Ruby to say their goodbyes. They prayed and cried. Eventually, physicians ceased compressions. Ruby had gone 45 minutes without a pulse. The EKG was still showing some irregularity, FDr. leischer said, but no rhythm. Physicians kept Ruby intubated as they waited for the background electrical activity to fade. As they watched the screen in anguish, there was suddenly a blip on the heart rate monitor. Then another and another. Within seconds, Ruby’s heart went back into sinus rhythm.

“We were in disbelief,” Dr. Fleischer said. “We did some tests and put her in the ICU, and she was fine. Usually, after doing compressions on anyone, you’d have bruising or broken ribs. She had nothing. She just woke up and said: ‘What am I doing here? Let me go see my baby.’ ”

Ruby fully recovered, and 3 days later, she went home with her newborn.

While the recovery was unbelievable, Dr. Fleischer stopped short of calling it a medical miracle. There were scientific contributors to her survival: she was immediately intubated when she stopped breathing and compressions were started as soon as her heart stopped.

However, Dr. Fleischer said the fact that lifesaving measures had ended, and Ruby revived on her own was indeed, miraculous.

“It wasn’t like we were doing compressions and brought her back,” he said. “I can scientifically explain things in my mind, except for that. That when we finally stopped and took our hands off her, that’s when something changed. That’s when she came back.”
 

How do ‘medical miracles’ impact physicians?

When Dr. Rotbart was writing his book, which includes physician essays from across the world, he was struck by how many of the events happened decades earlier.

“This is another testament to the powerful impact these experiences have on those witnessing them,” he said. “In many cases, physicians describing events occurring years ago noted that those early memories served to give them hope as they encountered new, seemingly hopeless cases in subsequent years. Some contributors wrote that the ‘miracle experience’ actually directed them in their choice of specialty and has influenced much of their professional decision-making throughout their careers. Others draw on those miraculous moments at times when they themselves feel hopeless in the face of adversity and tragedy.”

Dr. Fleischer said that, although Ruby’s story has stayed with him, his mindset or practice style didn’t necessarily change after the experience.

“I’m not sure if it’s affected me because I haven’t been in that situation again,” he said. “I’m in the middle. I would never rule out anything, but I’m not going to base how I practice on the hope for a medical miracle.”

In a recent opinion piece for the New York Times, pulmonary and critical care physician, Daniela Lamas, MD, wrote about the sometimes negative effects of miracle cases on physicians. Such experiences for instance, can lead to a greater drive to beat the odds in future cases, which can sometimes lead to false hope, protracted critical care admissions, and futile procedures. 

“After all, in most cases in the ICU, our initial prognoses are correct,” she wrote. “So there’s a risk to standing at the bedside, thinking about that one patient who made it home despite our predictions. We can give that experience too much weight in influencing our decisions and recommendations.”

Dr. Beam said unexpected outcomes – particularly in the age of COVID-19 – can certainly make physicians think differently about life-sustaining measures and when to discuss end-of-life care with family members. In his own practice, Dr. Beam has encountered unexpected COVID recoveries. Now, he generally gives extremely ill COVID patients a little more time to see if their bodies recover.

“It remains true that people who are really sick with COVID, who are on ventilated or who are requiring a lot of up respiratory support, they don’t do well on average,” he said. “But it is [also] true that there are a handful of people who get to that point and do come back to 80% or 90% of where they were. It makes you think twice.”
 

What to do when parents hope for a miracle

In his palliative care practice, Nashville, Tenn., surgeon Myrick Shinall Jr., MD, PhD, regularly encounters families and patients who wish for a medical miracle. 

“It happens pretty often from a palliative care perspective,” he said. “What I have experienced the most is a patient with a severe brain injury who we don’t believe is recoverable. The medical team is discussing with the family that it is probably time to discontinue the ventilator. In those situations, families will often talk about wanting us to continue on [our life-sustaining efforts] in the hopes that a miracle will happen.”

Dr. Shinall and Trevor Bibler, PhD, recently authored two articles about best practices for responding to patients who hope for a miracle. The first one, published in the American Journal of Bioethics, is directed toward bioethicists; the second article, in the Journal of Pain and Symptom Management, targets clinicians.

A primary takeaway from the papers is that health professionals should recognize that hope for a miracle may mean different things to different people, said Dr. Bibler, an ethicist and assistant professor at Baylor College of Medicine, Houston. Some patients may have an innocuous hope for a miracle without a religious connotation, whereas others may have a firm conviction in their idea of God, their spirituality, and a concrete vision of the miracle.

“To hear that a family or patient is hoping for a miracle, one shouldn’t assume they already know what the patient or the family might mean by that,” Dr. Bibler said. “If a patient were to say, ‘I hope for a miracle,’ you might ask: ‘What do you mean by a miracle?’ Health professionals should feel empowered to ask that question.”

Health care professionals should explore a patient’s hope for a miracle, be nonjudgmental, ask clarifying questions, restate what the patient has said, and delve into the patient’s world view on death and dying, according to Dr. Bibler’s analyses. In some cases, it may be helpful to include a chaplain or the presence of a theology outsider in discussions. 

When his patients and their families raise the subject of miracles, Dr. Shinall said he inquires what a miracle would look like in their opinion and tries to gauge how much of the assertion is a general hope compared with a firm belief. 

“I try to work with them to make sure they understand doctors’ decisions and recommendations are based on what we know and can predict from our medical experience,” he said. “And that there’s nothing we’re going to do to prevent a miracle from happening, but that that can’t be our medical plan – to wait for a miracle.”

Despite the many patients and families Dr. Shinall has encountered who hope for a miracle, he has never experienced a case that he would describe as a medical miracle, he said. 

Dr. Rotbart believes all physicians struggle with finding balance in how far to push in hope of a miracle and when to let go.

“Miracles, whether they happen to us, or we hear of them from colleagues or we read about them, should humble us as physicians,” he said. “I have come to believe that what we don’t know or don’t understand about medicine, medical miracles, or life in general, isn‘t necessarily cause for fear, and can even be reason for hope.

“Medicine has come a long way since Hippocrates’ theory of The Four Humors and The Four Temperaments, yet we still have much to learn about the workings of the human body. As physicians, we should take comfort in how much we don’t know because that allows us to share hope with our patients and, occasionally, makes medical miracles possible.”

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

It was a freezing December day, and two young brothers were playing outside near a swimming pool when the younger boy, a 3-year-old toddler, fell into the water.

The 7-year-old immediately jumped into the pool to save his brother and was able to pull the toddler to the pool steps where the boy’s head was above water. But the icy temperatures overcame the older brother and he drifted underwater.

“Despite being at the forefront of medicine, what we don’t understand often exceeds what we do understand,” said Harley Rotbart, MD, author of “Miracles We Have Seen” (Health Communications: Deerfield Beach, Fla., 2016).

Paramedics arrived to find both boys unconscious and rushed them to the Children’s Hospital of Philadelphia. The younger boy regained consciousness in the ICU and recovered. The 7-year-old, however, was unresponsive and remained in a coma, said Dr. Rotbart a pediatrician and author based in Denver.

Family members stayed at the boy’s bedside and prayed. But after several weeks, the child’s condition remained unchanged. His parents began to discuss ending life support and organ donation. Then late one night, as Dr. Rotbart sat reading to the unconscious patient, the little boy squeezed his hand. In disbelief, Dr. Rotbart told all of his colleagues about the squeeze the next morning. Everyone attributed the movement to an involuntary muscle spasm, he said. After all, every test and scan showed the boy had no brain function.

But later that day, the child grasped another staff member’s hand. Shortly after that, he squeezed in response to a command. Dr. Rotbart and his staff were stunned, but cautious about feeling too much hope. 

Days later, the child opened his eyes. Then, he smiled. His parents were overjoyed. 

“When he walked out of the hospital more than 2 months after the near-drowning and his heroic rescue of his little brother, we all cheered and cried,” Dr. Rotbart wrote in his book. “We cried many times in the weeks preceding, and I still cry whenever I recall this story.”

The experience, which happened years ago when Dr. Rotbart was a trainee, has stayed with the pediatrician his entire career. 

“His awakening was seemingly impossible – and then it happened,” Dr. Rotbart said. “Despite being at the forefront of medicine and science, what we don’t understand often exceeds what we do understand. And even when we think we understand, we are frequently proven wrong.”

For many, Dr. Rotbart’s experience raises questions about the existence of medical miracles. Although the term can have different definitions, a “medical miracle” generally refers to an unexpected recovery despite a dire prognosis. Frequently, the phrase has a religious connotation and is used to describe a supernatural or paranormal healing.

Do physicians believe in medical miracles? The answers are diverse.

“I have no doubt that extraordinary outcomes happen where patients who are overwhelmingly expected not to survive, do,” says Eric Beam, MD, a hospitalist based in San Diego. “That’s one of the reasons we choose our words very carefully in our conversations with patients and their families and remember that nothing is 0%, and nothing is 100%. But doctors tend to treat situations that are 99.9% as absolute. I don’t think you can practice medicine with the hope or expectation that every case you see has the potential to beat the odds – or be a medical miracle.”
 

Disappearing cancer hailed as ‘miracle’

In 2003, physicians projected that Joseph Rick, 40, had just a few months to live. His mucosal melanoma had spread throughout his body, progressing even after several surgeries, radiation therapy, and a combination of chemotherapy agents, recalled Antoni Ribas, MD, PhD, an oncologist and director of the tumor immunology program at Jonsson Comprehensive Cancer Center in Los Angeles.

Mr. Rick’s melanoma had spread to his intestines with traces on his stomach and bladder. Tumors were present on his liver, lungs, and pancreas. Rick bought a grave and prepared for the worst, he recounted in a Cancer Research Institute video. But his fate took a turn when he enrolled in an experimental drug trial in December 2003. The phase 1 trial was for a new immune modulating antibody, called an anti–CTLA-4 antibody, said Dr. Ribas, who conducted the trial. 

Over the next few weeks and months, all areas of Rick’s melanoma metastases disappeared. By 2009, he was in remission. He has lived the rest of his life with no evidence of melanoma, according to Dr. Ribas.

Mr. Rick’s case has been referenced throughout literature and news stories as a “medical miracle” and a “cancer miracle.”

Does Dr. Ribas think the case was a medical miracle?

“The response in Joseph Rick was what happened in 10%-15% of patients who received anti-CTLA-4 therapy,” Dr. Ribas said. “These were not miracles. These patients responded because their immune system trying to attack the cancer had been stuck at the CTLA-4 checkpoint. Blocking this checkpoint allowed their immune system to proceed to attack and kill cancer cells anywhere in the body.”

The scientific basis of this therapy was work by University of Texas MD Anderson Cancer Center immunologist James Allison, PhD, that had been done 5 years earlier in mouse models, where giving an anti–CTLA-4 antibody to mice allowed them to reject several implanted cancers, Dr. Ribas explained. Dr. Allison received the 2018 Nobel Prize in Physiology or Medicine for this work, subsequently opening the door for what we now call “immune checkpoint blockade therapy for cancer.” Dr. Ribas added.

“We tend to call miracles good things that we do not understand how they happened,” Dr. Ribas said. “From the human observation perspective, there have been plenty of medical miracles. However, each one has a specific biological mechanism that led to improvement in a patient. In cancer treatment, early studies using the immune system resulted in occasional patients having tumor responses and long-term benefits.

“With the increased understanding of how the immune system interacts with cancers, which is based on remarkable progress in understanding how the immune system works generated over the past several decades, these ‘miracles’ become specific mechanisms leading to response to cancer, which can then be replicated in other patients.”
 

Patient defies odds after 45 minutes without heartbeat

Florida ob.gyn. Michael Fleischer, MD, had just performed a routine repeat cesarean birth, delivering a healthy baby girl. His patient, Ruby, had a history of high blood pressure but medication taken during the pregnancy had kept her levels stabilized.

In the waiting room, Dr. Fleischer informed Ruby’s large family of the good news. He was planning to head home early that day when he heard his name being called over the hospital’s loudspeaker. Ruby had stopped breathing.

“The anesthesiologist was with her and had immediately intubated her,” Dr. Fleischer said. “We checked to make sure there was no problems or bleeding from the C-section, but everything was completely fine. However, we couldn’t keep her blood pressure stable.”

Dr. Fleischer suspected the respiratory arrest was caused by either an amniotic fluid embolism or a pulmonary embolism. Intubation continued and physicians gave Ruby medication to stabilize her blood pressure. Then suddenly, Ruby’s heart stopped.

Dr. Fleischer and other doctors began compressions, which they continued for 30 minutes. They shocked Ruby with defibrillator paddles multiple times, but there was no change.

“I was already thinking, this is hopeless, there’s nothing we can do,” he said. “The writing is on the wall. She’s going to die.”

Dr. Fleischer spoke to Ruby’s family and explained the tragic turn of events. Relatives were distraught and tearfully visited Ruby to say their goodbyes. They prayed and cried. Eventually, physicians ceased compressions. Ruby had gone 45 minutes without a pulse. The EKG was still showing some irregularity, FDr. leischer said, but no rhythm. Physicians kept Ruby intubated as they waited for the background electrical activity to fade. As they watched the screen in anguish, there was suddenly a blip on the heart rate monitor. Then another and another. Within seconds, Ruby’s heart went back into sinus rhythm.

“We were in disbelief,” Dr. Fleischer said. “We did some tests and put her in the ICU, and she was fine. Usually, after doing compressions on anyone, you’d have bruising or broken ribs. She had nothing. She just woke up and said: ‘What am I doing here? Let me go see my baby.’ ”

Ruby fully recovered, and 3 days later, she went home with her newborn.

While the recovery was unbelievable, Dr. Fleischer stopped short of calling it a medical miracle. There were scientific contributors to her survival: she was immediately intubated when she stopped breathing and compressions were started as soon as her heart stopped.

However, Dr. Fleischer said the fact that lifesaving measures had ended, and Ruby revived on her own was indeed, miraculous.

“It wasn’t like we were doing compressions and brought her back,” he said. “I can scientifically explain things in my mind, except for that. That when we finally stopped and took our hands off her, that’s when something changed. That’s when she came back.”
 

How do ‘medical miracles’ impact physicians?

When Dr. Rotbart was writing his book, which includes physician essays from across the world, he was struck by how many of the events happened decades earlier.

“This is another testament to the powerful impact these experiences have on those witnessing them,” he said. “In many cases, physicians describing events occurring years ago noted that those early memories served to give them hope as they encountered new, seemingly hopeless cases in subsequent years. Some contributors wrote that the ‘miracle experience’ actually directed them in their choice of specialty and has influenced much of their professional decision-making throughout their careers. Others draw on those miraculous moments at times when they themselves feel hopeless in the face of adversity and tragedy.”

Dr. Fleischer said that, although Ruby’s story has stayed with him, his mindset or practice style didn’t necessarily change after the experience.

“I’m not sure if it’s affected me because I haven’t been in that situation again,” he said. “I’m in the middle. I would never rule out anything, but I’m not going to base how I practice on the hope for a medical miracle.”

In a recent opinion piece for the New York Times, pulmonary and critical care physician, Daniela Lamas, MD, wrote about the sometimes negative effects of miracle cases on physicians. Such experiences for instance, can lead to a greater drive to beat the odds in future cases, which can sometimes lead to false hope, protracted critical care admissions, and futile procedures. 

“After all, in most cases in the ICU, our initial prognoses are correct,” she wrote. “So there’s a risk to standing at the bedside, thinking about that one patient who made it home despite our predictions. We can give that experience too much weight in influencing our decisions and recommendations.”

Dr. Beam said unexpected outcomes – particularly in the age of COVID-19 – can certainly make physicians think differently about life-sustaining measures and when to discuss end-of-life care with family members. In his own practice, Dr. Beam has encountered unexpected COVID recoveries. Now, he generally gives extremely ill COVID patients a little more time to see if their bodies recover.

“It remains true that people who are really sick with COVID, who are on ventilated or who are requiring a lot of up respiratory support, they don’t do well on average,” he said. “But it is [also] true that there are a handful of people who get to that point and do come back to 80% or 90% of where they were. It makes you think twice.”
 

What to do when parents hope for a miracle

In his palliative care practice, Nashville, Tenn., surgeon Myrick Shinall Jr., MD, PhD, regularly encounters families and patients who wish for a medical miracle. 

“It happens pretty often from a palliative care perspective,” he said. “What I have experienced the most is a patient with a severe brain injury who we don’t believe is recoverable. The medical team is discussing with the family that it is probably time to discontinue the ventilator. In those situations, families will often talk about wanting us to continue on [our life-sustaining efforts] in the hopes that a miracle will happen.”

Dr. Shinall and Trevor Bibler, PhD, recently authored two articles about best practices for responding to patients who hope for a miracle. The first one, published in the American Journal of Bioethics, is directed toward bioethicists; the second article, in the Journal of Pain and Symptom Management, targets clinicians.

A primary takeaway from the papers is that health professionals should recognize that hope for a miracle may mean different things to different people, said Dr. Bibler, an ethicist and assistant professor at Baylor College of Medicine, Houston. Some patients may have an innocuous hope for a miracle without a religious connotation, whereas others may have a firm conviction in their idea of God, their spirituality, and a concrete vision of the miracle.

“To hear that a family or patient is hoping for a miracle, one shouldn’t assume they already know what the patient or the family might mean by that,” Dr. Bibler said. “If a patient were to say, ‘I hope for a miracle,’ you might ask: ‘What do you mean by a miracle?’ Health professionals should feel empowered to ask that question.”

Health care professionals should explore a patient’s hope for a miracle, be nonjudgmental, ask clarifying questions, restate what the patient has said, and delve into the patient’s world view on death and dying, according to Dr. Bibler’s analyses. In some cases, it may be helpful to include a chaplain or the presence of a theology outsider in discussions. 

When his patients and their families raise the subject of miracles, Dr. Shinall said he inquires what a miracle would look like in their opinion and tries to gauge how much of the assertion is a general hope compared with a firm belief. 

“I try to work with them to make sure they understand doctors’ decisions and recommendations are based on what we know and can predict from our medical experience,” he said. “And that there’s nothing we’re going to do to prevent a miracle from happening, but that that can’t be our medical plan – to wait for a miracle.”

Despite the many patients and families Dr. Shinall has encountered who hope for a miracle, he has never experienced a case that he would describe as a medical miracle, he said. 

Dr. Rotbart believes all physicians struggle with finding balance in how far to push in hope of a miracle and when to let go.

“Miracles, whether they happen to us, or we hear of them from colleagues or we read about them, should humble us as physicians,” he said. “I have come to believe that what we don’t know or don’t understand about medicine, medical miracles, or life in general, isn‘t necessarily cause for fear, and can even be reason for hope.

“Medicine has come a long way since Hippocrates’ theory of The Four Humors and The Four Temperaments, yet we still have much to learn about the workings of the human body. As physicians, we should take comfort in how much we don’t know because that allows us to share hope with our patients and, occasionally, makes medical miracles possible.”

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