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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.

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 Food and Drug Administration has approved inclisiran (Leqvio) as an adjunct to statins for further reduction of LDL cholesterol levels, the drug’s developer, Novartis, announced on Dec. 22, 2021.

The first-in-class small interfering RNA (siRNA) agent is also novel among peer drug therapies for its administration by injection initially, at 3 months, and thereafter twice per year.

Inclisiran is indicated for use atop maximally tolerated statins in adults with clinical cardiovascular disease or in patients with heterozygous familial hypercholesterolemia, the company reported.

Such patients who received inclisiran, compared with placebo, in the ORION-9, ORION-10, and ORION-11 randomized trials on which the FDA approval was based showed LDL-C reductions exceeding 50% over 1-2 years.

The drug works by “silencing” RNA involved in synthesis of PCSK9, which has a role in controlling the number of LDL cholesterol cell-surface receptors, a unique mechanism of action among available treatments for dyslipidemia.

Novartis, the company said, “has obtained global rights to develop, manufacture, and commercialize Leqvio under a license and collaboration agreement with Alnylam Pharmaceuticals.”

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

The Food and Drug Administration has approved inclisiran (Leqvio) as an adjunct to statins for further reduction of LDL cholesterol levels, the drug’s developer, Novartis, announced on Dec. 22, 2021.

The first-in-class small interfering RNA (siRNA) agent is also novel among peer drug therapies for its administration by injection initially, at 3 months, and thereafter twice per year.

Inclisiran is indicated for use atop maximally tolerated statins in adults with clinical cardiovascular disease or in patients with heterozygous familial hypercholesterolemia, the company reported.

Such patients who received inclisiran, compared with placebo, in the ORION-9, ORION-10, and ORION-11 randomized trials on which the FDA approval was based showed LDL-C reductions exceeding 50% over 1-2 years.

The drug works by “silencing” RNA involved in synthesis of PCSK9, which has a role in controlling the number of LDL cholesterol cell-surface receptors, a unique mechanism of action among available treatments for dyslipidemia.

Novartis, the company said, “has obtained global rights to develop, manufacture, and commercialize Leqvio under a license and collaboration agreement with Alnylam Pharmaceuticals.”

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

The Food and Drug Administration has approved inclisiran (Leqvio) as an adjunct to statins for further reduction of LDL cholesterol levels, the drug’s developer, Novartis, announced on Dec. 22, 2021.

The first-in-class small interfering RNA (siRNA) agent is also novel among peer drug therapies for its administration by injection initially, at 3 months, and thereafter twice per year.

Inclisiran is indicated for use atop maximally tolerated statins in adults with clinical cardiovascular disease or in patients with heterozygous familial hypercholesterolemia, the company reported.

Such patients who received inclisiran, compared with placebo, in the ORION-9, ORION-10, and ORION-11 randomized trials on which the FDA approval was based showed LDL-C reductions exceeding 50% over 1-2 years.

The drug works by “silencing” RNA involved in synthesis of PCSK9, which has a role in controlling the number of LDL cholesterol cell-surface receptors, a unique mechanism of action among available treatments for dyslipidemia.

Novartis, the company said, “has obtained global rights to develop, manufacture, and commercialize Leqvio under a license and collaboration agreement with Alnylam Pharmaceuticals.”

A version of this article first appeared on Medscape.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.

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.

Interrogating the cardiac implantable electronic device (CIED) after death can yield important information about critical device malfunction, premortem abnormalities, and the mechanism and timing of death, a new study suggests.

Postmortem CIED interrogation is “richly informative” in assisting both cardiac and forensic investigations and “should be considered for select patients with CIEDs undergoing autopsy,” say Elizabeth Paratz, MBBS, department of cardiology, Baker Heart and Diabetes Institute, Prahran, Australia, and colleagues.

Their study results were published online in JACC: Clinical Electrophysiology. 

Cause of death revealed in half of cases

They reviewed CIED interrogations in 260 deceased individuals undergoing medicolegal investigation of sudden death (162 patients) or unexplained death (98 patients) by the Victorian Institute of Forensic Medicine between 2005 and 2020.

Roughly two-thirds were male (68.8%) and their median age was 72.8 years; 202 patients had pacemakers, 56 had defibrillators, and 2 had loop recorders. The cause of death was cardiac in 79.6% of cases.

Postmortem CIED interrogation was successful in 98.5% cases and directly informed cause of death in 131 cases (50.4%), with fatal ventricular arrhythmias identified in 121 patients.

CIED interrogation assisted in determining the cause of death in 63.6% of cases of sudden death and 28.6% of nonsudden death cases.

In 20 cases (7.7%), CIED interrogation uncovered potential device malfunction. Issues included failure to appropriately treat ventricular arrhythmias in 13 cases; lead issues in 3 cases, including 2 cases resulting in failure to treat ventricular arrhythmias; as well as battery depletion in 6 cases.

In 72 patients (27.7%), the device recorded abnormalities in the 30 days before death. These abnormalities included nonsustained ventricular tachycardia in 26 cases, rapid atrial fibrillation in 17, elective replacement indicator or end-of-life status in 22, intrathoracic impedance alarms or lead issues in 3 each, and therapy delivered in 1 instance.

“In several cases, the absence of an arrhythmia carried medicolegal implications: For example, in eight fatal motor vehicle accident cases, only one patient had a ventricular arrhythmia documented on their CIED,” Dr. Paratz and colleagues report.

And in six cases in which the patient was found dead after a prolonged period, CIED interrogation determined time of death. And in one case, CIED interrogation was the primary means of identifying the patient.

Still, postmortem CIED interrogation remains uncommon, the study team notes.

They point to a 2007 survey of Chicago morticians that found roughly 370 CIEDs were explanted per year prior to cremation, but only 4% of morticians had ever returned a CIED to the manufacturer for analysis.

“Encouraging postmortem interrogation of CIEDs may assist in postmarketing surveillance for critical faults, as well as in providing an electrophysiological appraisal of terminal rhythms and device responses in a variety of physiological scenarios,” the researchers say.

The study had no commercial funding. Dr. Paratz is supported by a National Health and Medical Research Council/National Heart Foundation cofunded Postgraduate Scholarship, Royal Australasian College of Physicians JJ Billings Scholarship, and PSA Insurance Cardiovascular Scholarship. The authors have disclosed no relevant financial relationships.

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

Interrogating the cardiac implantable electronic device (CIED) after death can yield important information about critical device malfunction, premortem abnormalities, and the mechanism and timing of death, a new study suggests.

Postmortem CIED interrogation is “richly informative” in assisting both cardiac and forensic investigations and “should be considered for select patients with CIEDs undergoing autopsy,” say Elizabeth Paratz, MBBS, department of cardiology, Baker Heart and Diabetes Institute, Prahran, Australia, and colleagues.

Their study results were published online in JACC: Clinical Electrophysiology. 

Cause of death revealed in half of cases

They reviewed CIED interrogations in 260 deceased individuals undergoing medicolegal investigation of sudden death (162 patients) or unexplained death (98 patients) by the Victorian Institute of Forensic Medicine between 2005 and 2020.

Roughly two-thirds were male (68.8%) and their median age was 72.8 years; 202 patients had pacemakers, 56 had defibrillators, and 2 had loop recorders. The cause of death was cardiac in 79.6% of cases.

Postmortem CIED interrogation was successful in 98.5% cases and directly informed cause of death in 131 cases (50.4%), with fatal ventricular arrhythmias identified in 121 patients.

CIED interrogation assisted in determining the cause of death in 63.6% of cases of sudden death and 28.6% of nonsudden death cases.

In 20 cases (7.7%), CIED interrogation uncovered potential device malfunction. Issues included failure to appropriately treat ventricular arrhythmias in 13 cases; lead issues in 3 cases, including 2 cases resulting in failure to treat ventricular arrhythmias; as well as battery depletion in 6 cases.

In 72 patients (27.7%), the device recorded abnormalities in the 30 days before death. These abnormalities included nonsustained ventricular tachycardia in 26 cases, rapid atrial fibrillation in 17, elective replacement indicator or end-of-life status in 22, intrathoracic impedance alarms or lead issues in 3 each, and therapy delivered in 1 instance.

“In several cases, the absence of an arrhythmia carried medicolegal implications: For example, in eight fatal motor vehicle accident cases, only one patient had a ventricular arrhythmia documented on their CIED,” Dr. Paratz and colleagues report.

And in six cases in which the patient was found dead after a prolonged period, CIED interrogation determined time of death. And in one case, CIED interrogation was the primary means of identifying the patient.

Still, postmortem CIED interrogation remains uncommon, the study team notes.

They point to a 2007 survey of Chicago morticians that found roughly 370 CIEDs were explanted per year prior to cremation, but only 4% of morticians had ever returned a CIED to the manufacturer for analysis.

“Encouraging postmortem interrogation of CIEDs may assist in postmarketing surveillance for critical faults, as well as in providing an electrophysiological appraisal of terminal rhythms and device responses in a variety of physiological scenarios,” the researchers say.

The study had no commercial funding. Dr. Paratz is supported by a National Health and Medical Research Council/National Heart Foundation cofunded Postgraduate Scholarship, Royal Australasian College of Physicians JJ Billings Scholarship, and PSA Insurance Cardiovascular Scholarship. The authors have disclosed no relevant financial relationships.

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

Interrogating the cardiac implantable electronic device (CIED) after death can yield important information about critical device malfunction, premortem abnormalities, and the mechanism and timing of death, a new study suggests.

Postmortem CIED interrogation is “richly informative” in assisting both cardiac and forensic investigations and “should be considered for select patients with CIEDs undergoing autopsy,” say Elizabeth Paratz, MBBS, department of cardiology, Baker Heart and Diabetes Institute, Prahran, Australia, and colleagues.

Their study results were published online in JACC: Clinical Electrophysiology. 

Cause of death revealed in half of cases

They reviewed CIED interrogations in 260 deceased individuals undergoing medicolegal investigation of sudden death (162 patients) or unexplained death (98 patients) by the Victorian Institute of Forensic Medicine between 2005 and 2020.

Roughly two-thirds were male (68.8%) and their median age was 72.8 years; 202 patients had pacemakers, 56 had defibrillators, and 2 had loop recorders. The cause of death was cardiac in 79.6% of cases.

Postmortem CIED interrogation was successful in 98.5% cases and directly informed cause of death in 131 cases (50.4%), with fatal ventricular arrhythmias identified in 121 patients.

CIED interrogation assisted in determining the cause of death in 63.6% of cases of sudden death and 28.6% of nonsudden death cases.

In 20 cases (7.7%), CIED interrogation uncovered potential device malfunction. Issues included failure to appropriately treat ventricular arrhythmias in 13 cases; lead issues in 3 cases, including 2 cases resulting in failure to treat ventricular arrhythmias; as well as battery depletion in 6 cases.

In 72 patients (27.7%), the device recorded abnormalities in the 30 days before death. These abnormalities included nonsustained ventricular tachycardia in 26 cases, rapid atrial fibrillation in 17, elective replacement indicator or end-of-life status in 22, intrathoracic impedance alarms or lead issues in 3 each, and therapy delivered in 1 instance.

“In several cases, the absence of an arrhythmia carried medicolegal implications: For example, in eight fatal motor vehicle accident cases, only one patient had a ventricular arrhythmia documented on their CIED,” Dr. Paratz and colleagues report.

And in six cases in which the patient was found dead after a prolonged period, CIED interrogation determined time of death. And in one case, CIED interrogation was the primary means of identifying the patient.

Still, postmortem CIED interrogation remains uncommon, the study team notes.

They point to a 2007 survey of Chicago morticians that found roughly 370 CIEDs were explanted per year prior to cremation, but only 4% of morticians had ever returned a CIED to the manufacturer for analysis.

“Encouraging postmortem interrogation of CIEDs may assist in postmarketing surveillance for critical faults, as well as in providing an electrophysiological appraisal of terminal rhythms and device responses in a variety of physiological scenarios,” the researchers say.

The study had no commercial funding. Dr. Paratz is supported by a National Health and Medical Research Council/National Heart Foundation cofunded Postgraduate Scholarship, Royal Australasian College of Physicians JJ Billings Scholarship, and PSA Insurance Cardiovascular Scholarship. The authors have disclosed no relevant financial relationships.

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

The drumbeat of U.S. recalls continues for various lots of extended-release metformin because of contamination with unacceptably high levels of a nitrosamine that pose a cancer risk.

On Dec. 28, 2021, Viona Pharmaceuticals voluntarily recalled 33 lots of metformin hydrochloride extended-release tablets, USP 750 mg to the retail level, as a precautionary measure, because of possible contamination with N-nitrosodimethylamine (NDMA).

Metformin is used as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus. Patients who have received impacted lots of metformin are advised to continue taking their medication and contact their physician for advice regarding an alternative treatment

The product can be identified as white to off-white, capsule shaped, uncoated tablets, debossed with “Z,” “C” on one side and “20” on the other side, and come in bottles of 100 tablets, which have been distributed nationwide. The 33 batch numbers are listed in a company statement.

The affected product was manufactured by Cadila Healthcare, Ahmedabad, India, for U.S. distribution by Viona.

In its statement, Viona said: “NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.”

This recall is being conducted “with the knowledge of the U.S. Food and Drug Administration,” it added.

Consumers with questions regarding this recall can contact the recall processor Eversana Life Science Services by phone at 1-888-304-5022, option 1; Monday-Friday, 8:00 a.m.–7:00 p.m. CT. Customers with medical-related questions who wish to report an adverse event or quality issues about the products being recalled should contact Viona Pharmaceuticals by phone at 888-304-5011, Monday-Friday, 8:30 p.m.–5:30 p.m., EST.
 

Latest in a long line of metformin recalls

This is the second time in 2021 that Viona has voluntarily recalled extended-release metformin tablets, 750 mg, because of potential contamination with NDMA. It recalled two lots in June, as reported by this news organization.

And in January 2021, Nostrum Laboratories recalled another lot of metformin extended-release 750-mg tablets, following on from a prior recall in November 2020.

These recalls follows 258 distinct U.S. lot recalls tracked by the FDA during the past 2 years because of unacceptably high NDMA levels in lots of metformin hydrochloride extended-release tablets.

The FDA has issued several statements about NDMA contamination of metformin formulations over the past 2 years, including a review of the methods used to detect NDMA and a summary of the information the agency had collected on excessive levels of NDMA in metformin.

According to the FDA’s 2020 summary, the agency has not yet determined how or why high levels of NDMA turn up so often in multiple batches of metformin hydrochloride extended-release tablets. However, published research attributed the contamination to certain methods of manufacturing metformin tablets.

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

The drumbeat of U.S. recalls continues for various lots of extended-release metformin because of contamination with unacceptably high levels of a nitrosamine that pose a cancer risk.

On Dec. 28, 2021, Viona Pharmaceuticals voluntarily recalled 33 lots of metformin hydrochloride extended-release tablets, USP 750 mg to the retail level, as a precautionary measure, because of possible contamination with N-nitrosodimethylamine (NDMA).

Metformin is used as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus. Patients who have received impacted lots of metformin are advised to continue taking their medication and contact their physician for advice regarding an alternative treatment

The product can be identified as white to off-white, capsule shaped, uncoated tablets, debossed with “Z,” “C” on one side and “20” on the other side, and come in bottles of 100 tablets, which have been distributed nationwide. The 33 batch numbers are listed in a company statement.

The affected product was manufactured by Cadila Healthcare, Ahmedabad, India, for U.S. distribution by Viona.

In its statement, Viona said: “NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.”

This recall is being conducted “with the knowledge of the U.S. Food and Drug Administration,” it added.

Consumers with questions regarding this recall can contact the recall processor Eversana Life Science Services by phone at 1-888-304-5022, option 1; Monday-Friday, 8:00 a.m.–7:00 p.m. CT. Customers with medical-related questions who wish to report an adverse event or quality issues about the products being recalled should contact Viona Pharmaceuticals by phone at 888-304-5011, Monday-Friday, 8:30 p.m.–5:30 p.m., EST.
 

Latest in a long line of metformin recalls

This is the second time in 2021 that Viona has voluntarily recalled extended-release metformin tablets, 750 mg, because of potential contamination with NDMA. It recalled two lots in June, as reported by this news organization.

And in January 2021, Nostrum Laboratories recalled another lot of metformin extended-release 750-mg tablets, following on from a prior recall in November 2020.

These recalls follows 258 distinct U.S. lot recalls tracked by the FDA during the past 2 years because of unacceptably high NDMA levels in lots of metformin hydrochloride extended-release tablets.

The FDA has issued several statements about NDMA contamination of metformin formulations over the past 2 years, including a review of the methods used to detect NDMA and a summary of the information the agency had collected on excessive levels of NDMA in metformin.

According to the FDA’s 2020 summary, the agency has not yet determined how or why high levels of NDMA turn up so often in multiple batches of metformin hydrochloride extended-release tablets. However, published research attributed the contamination to certain methods of manufacturing metformin tablets.

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

The drumbeat of U.S. recalls continues for various lots of extended-release metformin because of contamination with unacceptably high levels of a nitrosamine that pose a cancer risk.

On Dec. 28, 2021, Viona Pharmaceuticals voluntarily recalled 33 lots of metformin hydrochloride extended-release tablets, USP 750 mg to the retail level, as a precautionary measure, because of possible contamination with N-nitrosodimethylamine (NDMA).

Metformin is used as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus. Patients who have received impacted lots of metformin are advised to continue taking their medication and contact their physician for advice regarding an alternative treatment

The product can be identified as white to off-white, capsule shaped, uncoated tablets, debossed with “Z,” “C” on one side and “20” on the other side, and come in bottles of 100 tablets, which have been distributed nationwide. The 33 batch numbers are listed in a company statement.

The affected product was manufactured by Cadila Healthcare, Ahmedabad, India, for U.S. distribution by Viona.

In its statement, Viona said: “NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.”

This recall is being conducted “with the knowledge of the U.S. Food and Drug Administration,” it added.

Consumers with questions regarding this recall can contact the recall processor Eversana Life Science Services by phone at 1-888-304-5022, option 1; Monday-Friday, 8:00 a.m.–7:00 p.m. CT. Customers with medical-related questions who wish to report an adverse event or quality issues about the products being recalled should contact Viona Pharmaceuticals by phone at 888-304-5011, Monday-Friday, 8:30 p.m.–5:30 p.m., EST.
 

Latest in a long line of metformin recalls

This is the second time in 2021 that Viona has voluntarily recalled extended-release metformin tablets, 750 mg, because of potential contamination with NDMA. It recalled two lots in June, as reported by this news organization.

And in January 2021, Nostrum Laboratories recalled another lot of metformin extended-release 750-mg tablets, following on from a prior recall in November 2020.

These recalls follows 258 distinct U.S. lot recalls tracked by the FDA during the past 2 years because of unacceptably high NDMA levels in lots of metformin hydrochloride extended-release tablets.

The FDA has issued several statements about NDMA contamination of metformin formulations over the past 2 years, including a review of the methods used to detect NDMA and a summary of the information the agency had collected on excessive levels of NDMA in metformin.

According to the FDA’s 2020 summary, the agency has not yet determined how or why high levels of NDMA turn up so often in multiple batches of metformin hydrochloride extended-release tablets. However, published research attributed the contamination to certain methods of manufacturing metformin tablets.

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.

The ongoing COVID-19 pandemic was the biggest medical news or event of 2021, according to an overwhelming 84% of 987 of our readers who answered a recent Medscape Medical News poll. Perhaps no surprise there.

Coming in distant second, at 26%, was the new law requiring that patients be granted electronic access to clinical notes. The controversial Food and Drug Administration approval of aducanumab (Aduhelm, Biogen/Eisai) to treat Alzheimer’s disease was next, cited by almost 16% when asked what they would remember most about 2021.

Coming in at 10% or less were the permanent end to the Step 2 Clinical Skills test, the JAMA deputy editor resignation over controversial comments, and an “other” option that allowed for write-in responses.

It should be noted respondents could choose up to three answers to this and other questions in this survey, except for questions about profession and specialty.
 

Exciting news in 2021

Widespread availability of COVID-19 vaccines was the No. 1 response – chosen by 85% – when asked what medical news or events excited them in 2021.

FDA clearance of a 5-minute test for early dementia was selected by 22%, followed by almost 16% citing approval in October 2021 of abemaciclib (Verzenio, Lilly) “described as the first advance for early breast cancer in 20 years.”

The resignation of JAMA editors over a podcast on race rounded out the list of exciting medical news or events – coming in fourth at 11%. A total 5% of readers chose “other” and were asked to specify what news or events excited them in 2021.
 

A frustrating year?

Medscape also asked readers what medical news or events frustrated them in 2021. A majority, 81%, chose COVID-19 vaccine hesitancy or refusal. Almost one-third, 31%, chose the effect of climate change on health worldwide.

Some of the most memorable news or events of 2021 were also selected as frustrating by readers. For example, 22% were frustrated by the law requiring that patients be granted electronic access to clinical notes, followed by 19% who referred to the aducanumab approval in June. Furthermore, about 12% selected the JAMA resignations.
 

A shocking survey question

Asked what medical news or event from 2021 shocked readers, COVID-19 vaccine hesitancy or refusal was the most common answer, at 69%.

The U.S. Preventive Services Task Force ruling out aspirin in people over age 60 for primary prevention of cardiovascular disease shocked 36% of respondents.

Coming in third and fourth on the survey were the two JAMA editors resigning after a podcast on race, chosen by 19%, and the demise of the Step 2 Clinical Skills test, selected by 18%.

Interestingly, almost 96% of respondents were physicians. Less than 1% were residents, physician assistants, or nurses. Respondents also represented a wide range of specialties. From a list of 29 possible specialties, including “other,” family medicine, internal medicine, and psychiatry were the most common.

For more on the year that was 2021, see the Medscape Year in Medicine 2021: News That Made a Difference slideshow. Read Medscape’s full Year in Medicine report.

Wondering what stood out most to our readers in 2020? Here is a story about the results of a similar survey 1 year ago.

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

The ongoing COVID-19 pandemic was the biggest medical news or event of 2021, according to an overwhelming 84% of 987 of our readers who answered a recent Medscape Medical News poll. Perhaps no surprise there.

Coming in distant second, at 26%, was the new law requiring that patients be granted electronic access to clinical notes. The controversial Food and Drug Administration approval of aducanumab (Aduhelm, Biogen/Eisai) to treat Alzheimer’s disease was next, cited by almost 16% when asked what they would remember most about 2021.

Coming in at 10% or less were the permanent end to the Step 2 Clinical Skills test, the JAMA deputy editor resignation over controversial comments, and an “other” option that allowed for write-in responses.

It should be noted respondents could choose up to three answers to this and other questions in this survey, except for questions about profession and specialty.
 

Exciting news in 2021

Widespread availability of COVID-19 vaccines was the No. 1 response – chosen by 85% – when asked what medical news or events excited them in 2021.

FDA clearance of a 5-minute test for early dementia was selected by 22%, followed by almost 16% citing approval in October 2021 of abemaciclib (Verzenio, Lilly) “described as the first advance for early breast cancer in 20 years.”

The resignation of JAMA editors over a podcast on race rounded out the list of exciting medical news or events – coming in fourth at 11%. A total 5% of readers chose “other” and were asked to specify what news or events excited them in 2021.
 

A frustrating year?

Medscape also asked readers what medical news or events frustrated them in 2021. A majority, 81%, chose COVID-19 vaccine hesitancy or refusal. Almost one-third, 31%, chose the effect of climate change on health worldwide.

Some of the most memorable news or events of 2021 were also selected as frustrating by readers. For example, 22% were frustrated by the law requiring that patients be granted electronic access to clinical notes, followed by 19% who referred to the aducanumab approval in June. Furthermore, about 12% selected the JAMA resignations.
 

A shocking survey question

Asked what medical news or event from 2021 shocked readers, COVID-19 vaccine hesitancy or refusal was the most common answer, at 69%.

The U.S. Preventive Services Task Force ruling out aspirin in people over age 60 for primary prevention of cardiovascular disease shocked 36% of respondents.

Coming in third and fourth on the survey were the two JAMA editors resigning after a podcast on race, chosen by 19%, and the demise of the Step 2 Clinical Skills test, selected by 18%.

Interestingly, almost 96% of respondents were physicians. Less than 1% were residents, physician assistants, or nurses. Respondents also represented a wide range of specialties. From a list of 29 possible specialties, including “other,” family medicine, internal medicine, and psychiatry were the most common.

For more on the year that was 2021, see the Medscape Year in Medicine 2021: News That Made a Difference slideshow. Read Medscape’s full Year in Medicine report.

Wondering what stood out most to our readers in 2020? Here is a story about the results of a similar survey 1 year ago.

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

The ongoing COVID-19 pandemic was the biggest medical news or event of 2021, according to an overwhelming 84% of 987 of our readers who answered a recent Medscape Medical News poll. Perhaps no surprise there.

Coming in distant second, at 26%, was the new law requiring that patients be granted electronic access to clinical notes. The controversial Food and Drug Administration approval of aducanumab (Aduhelm, Biogen/Eisai) to treat Alzheimer’s disease was next, cited by almost 16% when asked what they would remember most about 2021.

Coming in at 10% or less were the permanent end to the Step 2 Clinical Skills test, the JAMA deputy editor resignation over controversial comments, and an “other” option that allowed for write-in responses.

It should be noted respondents could choose up to three answers to this and other questions in this survey, except for questions about profession and specialty.
 

Exciting news in 2021

Widespread availability of COVID-19 vaccines was the No. 1 response – chosen by 85% – when asked what medical news or events excited them in 2021.

FDA clearance of a 5-minute test for early dementia was selected by 22%, followed by almost 16% citing approval in October 2021 of abemaciclib (Verzenio, Lilly) “described as the first advance for early breast cancer in 20 years.”

The resignation of JAMA editors over a podcast on race rounded out the list of exciting medical news or events – coming in fourth at 11%. A total 5% of readers chose “other” and were asked to specify what news or events excited them in 2021.
 

A frustrating year?

Medscape also asked readers what medical news or events frustrated them in 2021. A majority, 81%, chose COVID-19 vaccine hesitancy or refusal. Almost one-third, 31%, chose the effect of climate change on health worldwide.

Some of the most memorable news or events of 2021 were also selected as frustrating by readers. For example, 22% were frustrated by the law requiring that patients be granted electronic access to clinical notes, followed by 19% who referred to the aducanumab approval in June. Furthermore, about 12% selected the JAMA resignations.
 

A shocking survey question

Asked what medical news or event from 2021 shocked readers, COVID-19 vaccine hesitancy or refusal was the most common answer, at 69%.

The U.S. Preventive Services Task Force ruling out aspirin in people over age 60 for primary prevention of cardiovascular disease shocked 36% of respondents.

Coming in third and fourth on the survey were the two JAMA editors resigning after a podcast on race, chosen by 19%, and the demise of the Step 2 Clinical Skills test, selected by 18%.

Interestingly, almost 96% of respondents were physicians. Less than 1% were residents, physician assistants, or nurses. Respondents also represented a wide range of specialties. From a list of 29 possible specialties, including “other,” family medicine, internal medicine, and psychiatry were the most common.

For more on the year that was 2021, see the Medscape Year in Medicine 2021: News That Made a Difference slideshow. Read Medscape’s full Year in Medicine report.

Wondering what stood out most to our readers in 2020? Here is a story about the results of a similar survey 1 year ago.

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