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Customizing pre-CAR T chemotherapy could improve ALL patient outcomes
The findings, if validated in a prospective study, could help cut the rate of relapses after initial response to CAR T-cell therapy, which currently approaches 50%, the investigators noted.
In 152 pediatric and young adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL) who underwent CD-19-directed CAR T-cell therapy after cyclophosphamide/fludarabine lymphodepleting chemotherapy, estimated fludarabine exposure was associated with cumulative incidence of relapse (CIR) and a composite endpoint that included loss of B-cell aplasia (BCA) or relapse, Vanessa Fabrizio, MD, and colleagues found.
Dr. Fabrizio, a pediatric hematologist and oncologist at Children’s Hospital Colorado and the University of Colorado Cancer Center in Aurora, was a fellow at Memorial Sloan Kettering (MSK) Cancer Center during the study.
Optimal fludarabine exposure was identified by the investigators as an area under the curve (AUC) of at least 13.8 mg*hr/L. The fludarabine exposure AUC was calculated for each patient by using a validated pharmacokinetics population model.
Multivariable analyses controlling for baseline patient factors and fludarabine exposure showed that patients without optimal exposure had a 2.5-fold higher CIR (hazard ratio, 2.45), and a twofold higher risk of relapse or loss of BCA (HR, 1.96), compared with those who had optimal fludarabine exposure, they reported.
High pre-infusion disease burden was associated with an increased risk of relapse and death (HRs, 2.66 and 4.77, respectively), they said.
The study was published online Nov. 17 in Blood Advances.
“We know that [with] fludarabine ... everyone’s body clears it differently,” principal investigator Kevin J. Curran, MD, said in an interview.
Factors affecting clearance include kidney function and weight, and it is simple to determine the optimal dose based on these factors and apply that in practice, said Dr. Curran, a pediatric oncologist and assistant attending physician specializing in cellular therapy at MSK Kids.
In fact, in prior studies, optimal fludarabine exposure in patients undergoing allogeneic hematopoietic cell transplantation has been shown to “decrease nonrelapse mortality due to improved immune reconstitution and subsequently improve survival,” he and his colleagues wrote, explaining the rationale for the study.
The participants, who were part of the Pediatric Real-World CAR Consortium (PRWCC), had a median age of 12.5 years, and 131 of 152 (86%) responded to CAR T-cell therapy. The 12-month OS was 75.1%, the 12-month CIR was 36.4%, and 67% of patients had optimal fludarabine exposure, the authors said.
The findings indeed suggest that one way to improve outcomes without changing the actual cell therapy is to tailor the lymphodepleting therapy prior to CAR T-cell therapy, said Dr. Curran.
“That’s what this does. It’s exciting because cell therapy is very effective [in terms of] initial response, but what we don’t like is the durability of the response,” he said “The next step is to prove it in a prospective study.”
A phase 2 study looking at personalized dosing, as opposed to the standard 30 mg/m2 that most patients receive, is planned for 2022, he noted.
The study was supported by a St Baldrick’s/Stand Up 2 Cancer Pediatric Dream Team Translational Cancer Research Grant, the Virginia and D.K. Ludwig Fund for Cancer Research, and a National Cancer Institute Cancer Center Support Grant. Dr. Curran has served as a consultant for Novartis and Mesoblast, and received research funding from Novartis and Celgene. Dr. Fabrizio reported having no disclosures.
The findings, if validated in a prospective study, could help cut the rate of relapses after initial response to CAR T-cell therapy, which currently approaches 50%, the investigators noted.
In 152 pediatric and young adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL) who underwent CD-19-directed CAR T-cell therapy after cyclophosphamide/fludarabine lymphodepleting chemotherapy, estimated fludarabine exposure was associated with cumulative incidence of relapse (CIR) and a composite endpoint that included loss of B-cell aplasia (BCA) or relapse, Vanessa Fabrizio, MD, and colleagues found.
Dr. Fabrizio, a pediatric hematologist and oncologist at Children’s Hospital Colorado and the University of Colorado Cancer Center in Aurora, was a fellow at Memorial Sloan Kettering (MSK) Cancer Center during the study.
Optimal fludarabine exposure was identified by the investigators as an area under the curve (AUC) of at least 13.8 mg*hr/L. The fludarabine exposure AUC was calculated for each patient by using a validated pharmacokinetics population model.
Multivariable analyses controlling for baseline patient factors and fludarabine exposure showed that patients without optimal exposure had a 2.5-fold higher CIR (hazard ratio, 2.45), and a twofold higher risk of relapse or loss of BCA (HR, 1.96), compared with those who had optimal fludarabine exposure, they reported.
High pre-infusion disease burden was associated with an increased risk of relapse and death (HRs, 2.66 and 4.77, respectively), they said.
The study was published online Nov. 17 in Blood Advances.
“We know that [with] fludarabine ... everyone’s body clears it differently,” principal investigator Kevin J. Curran, MD, said in an interview.
Factors affecting clearance include kidney function and weight, and it is simple to determine the optimal dose based on these factors and apply that in practice, said Dr. Curran, a pediatric oncologist and assistant attending physician specializing in cellular therapy at MSK Kids.
In fact, in prior studies, optimal fludarabine exposure in patients undergoing allogeneic hematopoietic cell transplantation has been shown to “decrease nonrelapse mortality due to improved immune reconstitution and subsequently improve survival,” he and his colleagues wrote, explaining the rationale for the study.
The participants, who were part of the Pediatric Real-World CAR Consortium (PRWCC), had a median age of 12.5 years, and 131 of 152 (86%) responded to CAR T-cell therapy. The 12-month OS was 75.1%, the 12-month CIR was 36.4%, and 67% of patients had optimal fludarabine exposure, the authors said.
The findings indeed suggest that one way to improve outcomes without changing the actual cell therapy is to tailor the lymphodepleting therapy prior to CAR T-cell therapy, said Dr. Curran.
“That’s what this does. It’s exciting because cell therapy is very effective [in terms of] initial response, but what we don’t like is the durability of the response,” he said “The next step is to prove it in a prospective study.”
A phase 2 study looking at personalized dosing, as opposed to the standard 30 mg/m2 that most patients receive, is planned for 2022, he noted.
The study was supported by a St Baldrick’s/Stand Up 2 Cancer Pediatric Dream Team Translational Cancer Research Grant, the Virginia and D.K. Ludwig Fund for Cancer Research, and a National Cancer Institute Cancer Center Support Grant. Dr. Curran has served as a consultant for Novartis and Mesoblast, and received research funding from Novartis and Celgene. Dr. Fabrizio reported having no disclosures.
The findings, if validated in a prospective study, could help cut the rate of relapses after initial response to CAR T-cell therapy, which currently approaches 50%, the investigators noted.
In 152 pediatric and young adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL) who underwent CD-19-directed CAR T-cell therapy after cyclophosphamide/fludarabine lymphodepleting chemotherapy, estimated fludarabine exposure was associated with cumulative incidence of relapse (CIR) and a composite endpoint that included loss of B-cell aplasia (BCA) or relapse, Vanessa Fabrizio, MD, and colleagues found.
Dr. Fabrizio, a pediatric hematologist and oncologist at Children’s Hospital Colorado and the University of Colorado Cancer Center in Aurora, was a fellow at Memorial Sloan Kettering (MSK) Cancer Center during the study.
Optimal fludarabine exposure was identified by the investigators as an area under the curve (AUC) of at least 13.8 mg*hr/L. The fludarabine exposure AUC was calculated for each patient by using a validated pharmacokinetics population model.
Multivariable analyses controlling for baseline patient factors and fludarabine exposure showed that patients without optimal exposure had a 2.5-fold higher CIR (hazard ratio, 2.45), and a twofold higher risk of relapse or loss of BCA (HR, 1.96), compared with those who had optimal fludarabine exposure, they reported.
High pre-infusion disease burden was associated with an increased risk of relapse and death (HRs, 2.66 and 4.77, respectively), they said.
The study was published online Nov. 17 in Blood Advances.
“We know that [with] fludarabine ... everyone’s body clears it differently,” principal investigator Kevin J. Curran, MD, said in an interview.
Factors affecting clearance include kidney function and weight, and it is simple to determine the optimal dose based on these factors and apply that in practice, said Dr. Curran, a pediatric oncologist and assistant attending physician specializing in cellular therapy at MSK Kids.
In fact, in prior studies, optimal fludarabine exposure in patients undergoing allogeneic hematopoietic cell transplantation has been shown to “decrease nonrelapse mortality due to improved immune reconstitution and subsequently improve survival,” he and his colleagues wrote, explaining the rationale for the study.
The participants, who were part of the Pediatric Real-World CAR Consortium (PRWCC), had a median age of 12.5 years, and 131 of 152 (86%) responded to CAR T-cell therapy. The 12-month OS was 75.1%, the 12-month CIR was 36.4%, and 67% of patients had optimal fludarabine exposure, the authors said.
The findings indeed suggest that one way to improve outcomes without changing the actual cell therapy is to tailor the lymphodepleting therapy prior to CAR T-cell therapy, said Dr. Curran.
“That’s what this does. It’s exciting because cell therapy is very effective [in terms of] initial response, but what we don’t like is the durability of the response,” he said “The next step is to prove it in a prospective study.”
A phase 2 study looking at personalized dosing, as opposed to the standard 30 mg/m2 that most patients receive, is planned for 2022, he noted.
The study was supported by a St Baldrick’s/Stand Up 2 Cancer Pediatric Dream Team Translational Cancer Research Grant, the Virginia and D.K. Ludwig Fund for Cancer Research, and a National Cancer Institute Cancer Center Support Grant. Dr. Curran has served as a consultant for Novartis and Mesoblast, and received research funding from Novartis and Celgene. Dr. Fabrizio reported having no disclosures.
FROM BLOOD ADVANCES
FDA authorizes Pfizer boosters for 16- and 17-year-olds
, clearing the way for millions of teenagers to get a third dose of vaccine starting 6 months after their second dose.
The FDA said it was basing its emergency authorization of boosters for 16- and 17-year-olds on data from 200 individuals who were 18-55 years of age when they received a booster dose. They are requiring Pfizer to collect data on safety in postauthorization studies.
“The FDA has determined that the benefits of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine or Comirnaty outweigh the risks of myocarditis and pericarditis in individuals 16 and 17 years of age to provide continued protection against COVID-19 and the associated serious consequences that can occur including hospitalization and death,” the agency said in a news release.
Israel has been giving booster doses of Pfizer’s vaccine to everyone 12 and up since late August. Data from that country show that myocarditis cases continue to be very rare, even in younger age groups, and are mild and temporary.
The authorization comes as the effectiveness of the current vaccines against the new Omicron variant has become a point of intense scientific inquiry.
Early studies suggest that booster doses may be necessary to keep Omicron at bay, at least until new variant-specific vaccines are ready next spring.
Current evidence suggests that the protection of the vaccines is holding up well against severe disease and death, at least with Delta and early iterations of the virus.
How well they will do against Omicron, and how severe Omicron infections may be for different age groups, remain open questions.
On Dec. 8, the World Health Organization urged countries not to wait for all the science to come in, but to act now to contain any potential threat.
The first pieces of evidence on Omicron suggest that it is highly contagious, perhaps even more than Delta, though early reports suggest symptoms caused by this version of the new coronavirus may be less severe than in previous waves. Experts have cautioned that the true severity of Omicron infections isn’t yet known, since the first cases have been detected in younger people, who tend to have milder COVID-19 symptoms than those of adults and seniors.
“Vaccination and getting a booster when eligible, along with other preventive measures like masking and avoiding large crowds and poorly ventilated spaces, remain our most effective methods for fighting COVID-19,” Acting FDA Commissioner Janet Woodcock, MD, said in a news release. “As people gather indoors with family and friends for the holidays, we can’t let up on all the preventive public health measures that we have been taking during the pandemic. With both the Delta and Omicron variants continuing to spread, vaccination remains the best protection against COVID-19.”
In mid-November, the FDA authorized boosters of the Pfizer vaccine for all individuals 18 and older, but the agency held off on expanding the use of boosters for younger age groups, partly because they have the highest risk of myocarditis, a very rare side effect.
Myocarditis cases seem to be temporary, with patients making a full recovery, though they need to be monitored in the hospital. The risk of myocarditis with a COVID-19 infection is many times higher than it is from a vaccine.
There have been little data to support the need for boosters in this age group, because children and teens tend to experience milder COVID-19 disease, though they are still at risk for post–COVID-19 complications such as long COVID and a delayed reaction to the virus called Post Acute Sequelae of SARS-CoV2 Infection among Children, or PAS-C.
All that changed with the arrival of Omicron.
A version of this article first appeared on WebMD.com.
, clearing the way for millions of teenagers to get a third dose of vaccine starting 6 months after their second dose.
The FDA said it was basing its emergency authorization of boosters for 16- and 17-year-olds on data from 200 individuals who were 18-55 years of age when they received a booster dose. They are requiring Pfizer to collect data on safety in postauthorization studies.
“The FDA has determined that the benefits of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine or Comirnaty outweigh the risks of myocarditis and pericarditis in individuals 16 and 17 years of age to provide continued protection against COVID-19 and the associated serious consequences that can occur including hospitalization and death,” the agency said in a news release.
Israel has been giving booster doses of Pfizer’s vaccine to everyone 12 and up since late August. Data from that country show that myocarditis cases continue to be very rare, even in younger age groups, and are mild and temporary.
The authorization comes as the effectiveness of the current vaccines against the new Omicron variant has become a point of intense scientific inquiry.
Early studies suggest that booster doses may be necessary to keep Omicron at bay, at least until new variant-specific vaccines are ready next spring.
Current evidence suggests that the protection of the vaccines is holding up well against severe disease and death, at least with Delta and early iterations of the virus.
How well they will do against Omicron, and how severe Omicron infections may be for different age groups, remain open questions.
On Dec. 8, the World Health Organization urged countries not to wait for all the science to come in, but to act now to contain any potential threat.
The first pieces of evidence on Omicron suggest that it is highly contagious, perhaps even more than Delta, though early reports suggest symptoms caused by this version of the new coronavirus may be less severe than in previous waves. Experts have cautioned that the true severity of Omicron infections isn’t yet known, since the first cases have been detected in younger people, who tend to have milder COVID-19 symptoms than those of adults and seniors.
“Vaccination and getting a booster when eligible, along with other preventive measures like masking and avoiding large crowds and poorly ventilated spaces, remain our most effective methods for fighting COVID-19,” Acting FDA Commissioner Janet Woodcock, MD, said in a news release. “As people gather indoors with family and friends for the holidays, we can’t let up on all the preventive public health measures that we have been taking during the pandemic. With both the Delta and Omicron variants continuing to spread, vaccination remains the best protection against COVID-19.”
In mid-November, the FDA authorized boosters of the Pfizer vaccine for all individuals 18 and older, but the agency held off on expanding the use of boosters for younger age groups, partly because they have the highest risk of myocarditis, a very rare side effect.
Myocarditis cases seem to be temporary, with patients making a full recovery, though they need to be monitored in the hospital. The risk of myocarditis with a COVID-19 infection is many times higher than it is from a vaccine.
There have been little data to support the need for boosters in this age group, because children and teens tend to experience milder COVID-19 disease, though they are still at risk for post–COVID-19 complications such as long COVID and a delayed reaction to the virus called Post Acute Sequelae of SARS-CoV2 Infection among Children, or PAS-C.
All that changed with the arrival of Omicron.
A version of this article first appeared on WebMD.com.
, clearing the way for millions of teenagers to get a third dose of vaccine starting 6 months after their second dose.
The FDA said it was basing its emergency authorization of boosters for 16- and 17-year-olds on data from 200 individuals who were 18-55 years of age when they received a booster dose. They are requiring Pfizer to collect data on safety in postauthorization studies.
“The FDA has determined that the benefits of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine or Comirnaty outweigh the risks of myocarditis and pericarditis in individuals 16 and 17 years of age to provide continued protection against COVID-19 and the associated serious consequences that can occur including hospitalization and death,” the agency said in a news release.
Israel has been giving booster doses of Pfizer’s vaccine to everyone 12 and up since late August. Data from that country show that myocarditis cases continue to be very rare, even in younger age groups, and are mild and temporary.
The authorization comes as the effectiveness of the current vaccines against the new Omicron variant has become a point of intense scientific inquiry.
Early studies suggest that booster doses may be necessary to keep Omicron at bay, at least until new variant-specific vaccines are ready next spring.
Current evidence suggests that the protection of the vaccines is holding up well against severe disease and death, at least with Delta and early iterations of the virus.
How well they will do against Omicron, and how severe Omicron infections may be for different age groups, remain open questions.
On Dec. 8, the World Health Organization urged countries not to wait for all the science to come in, but to act now to contain any potential threat.
The first pieces of evidence on Omicron suggest that it is highly contagious, perhaps even more than Delta, though early reports suggest symptoms caused by this version of the new coronavirus may be less severe than in previous waves. Experts have cautioned that the true severity of Omicron infections isn’t yet known, since the first cases have been detected in younger people, who tend to have milder COVID-19 symptoms than those of adults and seniors.
“Vaccination and getting a booster when eligible, along with other preventive measures like masking and avoiding large crowds and poorly ventilated spaces, remain our most effective methods for fighting COVID-19,” Acting FDA Commissioner Janet Woodcock, MD, said in a news release. “As people gather indoors with family and friends for the holidays, we can’t let up on all the preventive public health measures that we have been taking during the pandemic. With both the Delta and Omicron variants continuing to spread, vaccination remains the best protection against COVID-19.”
In mid-November, the FDA authorized boosters of the Pfizer vaccine for all individuals 18 and older, but the agency held off on expanding the use of boosters for younger age groups, partly because they have the highest risk of myocarditis, a very rare side effect.
Myocarditis cases seem to be temporary, with patients making a full recovery, though they need to be monitored in the hospital. The risk of myocarditis with a COVID-19 infection is many times higher than it is from a vaccine.
There have been little data to support the need for boosters in this age group, because children and teens tend to experience milder COVID-19 disease, though they are still at risk for post–COVID-19 complications such as long COVID and a delayed reaction to the virus called Post Acute Sequelae of SARS-CoV2 Infection among Children, or PAS-C.
All that changed with the arrival of Omicron.
A version of this article first appeared on WebMD.com.
Medical board stops warning docs against giving false COVID information
Under pressure from Republican state lawmakers, t
The board’s 7-3 vote on December 7 to delete the statement followed repeated threats by a powerful state House Republican to dissolve the board and appoint all new members if it did not immediately take it down.
The Tennessee board’s statement was a verbatim restatement of a warning to physicians issued by the Federation of State Medical Boards in July. The federation cited a “dramatic increase” in dissemination of misinformation and disinformation about the COVID-19 vaccine by physicians. It said that’s dangerous because physicians enjoy a high degree of public credibility.
Across the country, state medical licensing boards and state and national medical associations and specialty boards are struggling with how to respond to scientifically baseless public statements about COVID-19 by some physicians, which they say are increasing public confusion, political conflict, and preventable illnesses and deaths.
There have been only a small number of disciplinary actions by medical boards against physicians for spreading false COVID-19 information. Critics say the boards have been weak in responding to these dangerous violations of medical standards. As an example, they cite the State Medical Board of Ohio’s September renewal of the medical license of Sherri Tenpenny, DO, who had previously testified before Ohio lawmakers that COVID-19 vaccines magnetize their recipients and “interface” with cell phone towers.
“I’m not satisfied with what medical boards have done, and we are ramping up our efforts to press the boards to hold these physicians accountable,” said Nick Sawyer, MD, an emergency physician in Sacramento, Calif., who heads a group of healthcare professionals called No License for Disinformation.
Still, Tennessee board members insisted that the board’s policy of disciplining physicians who disseminate false information about COVID-19 vaccinations remains in effect, because state law empowers the board to take action against doctors whose unprofessional behavior endangers the public.
“COVID misinformation and disinformation has caused undue loss of life and jobs and other incalculable loss in our society,” said Melanie Blake, MD, MBA, a Chattanooga internist who’s president of the board. “Physicians have a responsibility to uphold their oath and put forward consensus-driven medical principles.”
But state Rep. John Ragan, the Republican co-chairman of the Joint Government Operations Committee, told the Tennessean newspaper that deleting the statement from the board’s website was equivalent to rescinding the policy. Ragan, who identifies himself as a business consultant and retired Air Force pilot, did not respond to a request for comment for this article.
Blake acknowledged that removing the statement from the board’s website has the potential to confuse Tennessee physicians. And the pressure from GOP lawmakers, who overwhelmingly control the Tennessee legislature, could discourage investigations and disciplinary actions against physicians who allegedly spread COVID-19 misinformation, she added. “It’s hard for me to answer whether this puts a chill on us,” she said.
In September, the Tennessee board, besides approving the general statement that physicians who spread COVID-19 disinformation could face licensure action, also directed the State Department of Health to prioritize investigations of physicians who spread outrageous claims. The board cited statements such as the vaccines are poisonous, cause infertility, contain microchips, or magnetize the body.
In response, the Tennessee General Assembly passed a bill in late October prohibiting the board from implementing any disciplinary process regarding the prescribing of “medication for COVID-19” without review and approval by Ragan’s committee. It’s not clear whether that language covers vaccines.
Last summer, in a similar move, Ragan threatened to dissolve the State Department of Health because its top vaccination official wrote a letter to medical providers explaining that state law allowed them to give COVID-19 vaccinations to minors older than 14 without parental consent. That official, Michelle Fiscus, MD, was fired in July.
Republican Sen. Richard Briggs, MD, a cardiothoracic surgeon who voted against the October legislation affecting COVID-related disciplinary actions, criticized his GOP colleagues’ interference in the medical board’s licensure decisions. “The mission of the board is to protect the health and safety of Tennessee citizens, and this was in complete conflict with that mission,” he said.
The Federation of State Medical Boards similarly condemned the Tennessee lawmakers’ moves. “The FSMB strongly opposes restricting a board’s authority to evaluate the standard of care and assess potential risk for patient harm,” a spokesman said. “Any interference, politically motivated or otherwise, is unhelpful and dangerous.”
But Arthur Caplan, PhD, a professor of bioethics at NYU School of Medicine, doubts that state medical boards are up to the task of policing disinformation spread by physicians. That’s because they ultimately are under the control of elected state officials, who may force the boards to base policy on ideology rather than science.
He said medical board members in Florida and another GOP-controlled state have told him they do not want to pursue disciplinary actions against physicians for COVID-19 misinformation for fear of political backlash.
Michele Heisler, MD, medical director of Physicians for Human Rights, agreed that the Tennessee situation highlights the looming political threat to the independence of state medical boards. She urged other medical organizations, particularly medical specialty boards, to step in.
“As a profession, we need to take a stance against this,” said Heisler, who’s a professor of internal medicine and public health at the University of Michigan. “Our credibility as physicians is at stake.”
A version of this article first appeared on Medscape.com.
Under pressure from Republican state lawmakers, t
The board’s 7-3 vote on December 7 to delete the statement followed repeated threats by a powerful state House Republican to dissolve the board and appoint all new members if it did not immediately take it down.
The Tennessee board’s statement was a verbatim restatement of a warning to physicians issued by the Federation of State Medical Boards in July. The federation cited a “dramatic increase” in dissemination of misinformation and disinformation about the COVID-19 vaccine by physicians. It said that’s dangerous because physicians enjoy a high degree of public credibility.
Across the country, state medical licensing boards and state and national medical associations and specialty boards are struggling with how to respond to scientifically baseless public statements about COVID-19 by some physicians, which they say are increasing public confusion, political conflict, and preventable illnesses and deaths.
There have been only a small number of disciplinary actions by medical boards against physicians for spreading false COVID-19 information. Critics say the boards have been weak in responding to these dangerous violations of medical standards. As an example, they cite the State Medical Board of Ohio’s September renewal of the medical license of Sherri Tenpenny, DO, who had previously testified before Ohio lawmakers that COVID-19 vaccines magnetize their recipients and “interface” with cell phone towers.
“I’m not satisfied with what medical boards have done, and we are ramping up our efforts to press the boards to hold these physicians accountable,” said Nick Sawyer, MD, an emergency physician in Sacramento, Calif., who heads a group of healthcare professionals called No License for Disinformation.
Still, Tennessee board members insisted that the board’s policy of disciplining physicians who disseminate false information about COVID-19 vaccinations remains in effect, because state law empowers the board to take action against doctors whose unprofessional behavior endangers the public.
“COVID misinformation and disinformation has caused undue loss of life and jobs and other incalculable loss in our society,” said Melanie Blake, MD, MBA, a Chattanooga internist who’s president of the board. “Physicians have a responsibility to uphold their oath and put forward consensus-driven medical principles.”
But state Rep. John Ragan, the Republican co-chairman of the Joint Government Operations Committee, told the Tennessean newspaper that deleting the statement from the board’s website was equivalent to rescinding the policy. Ragan, who identifies himself as a business consultant and retired Air Force pilot, did not respond to a request for comment for this article.
Blake acknowledged that removing the statement from the board’s website has the potential to confuse Tennessee physicians. And the pressure from GOP lawmakers, who overwhelmingly control the Tennessee legislature, could discourage investigations and disciplinary actions against physicians who allegedly spread COVID-19 misinformation, she added. “It’s hard for me to answer whether this puts a chill on us,” she said.
In September, the Tennessee board, besides approving the general statement that physicians who spread COVID-19 disinformation could face licensure action, also directed the State Department of Health to prioritize investigations of physicians who spread outrageous claims. The board cited statements such as the vaccines are poisonous, cause infertility, contain microchips, or magnetize the body.
In response, the Tennessee General Assembly passed a bill in late October prohibiting the board from implementing any disciplinary process regarding the prescribing of “medication for COVID-19” without review and approval by Ragan’s committee. It’s not clear whether that language covers vaccines.
Last summer, in a similar move, Ragan threatened to dissolve the State Department of Health because its top vaccination official wrote a letter to medical providers explaining that state law allowed them to give COVID-19 vaccinations to minors older than 14 without parental consent. That official, Michelle Fiscus, MD, was fired in July.
Republican Sen. Richard Briggs, MD, a cardiothoracic surgeon who voted against the October legislation affecting COVID-related disciplinary actions, criticized his GOP colleagues’ interference in the medical board’s licensure decisions. “The mission of the board is to protect the health and safety of Tennessee citizens, and this was in complete conflict with that mission,” he said.
The Federation of State Medical Boards similarly condemned the Tennessee lawmakers’ moves. “The FSMB strongly opposes restricting a board’s authority to evaluate the standard of care and assess potential risk for patient harm,” a spokesman said. “Any interference, politically motivated or otherwise, is unhelpful and dangerous.”
But Arthur Caplan, PhD, a professor of bioethics at NYU School of Medicine, doubts that state medical boards are up to the task of policing disinformation spread by physicians. That’s because they ultimately are under the control of elected state officials, who may force the boards to base policy on ideology rather than science.
He said medical board members in Florida and another GOP-controlled state have told him they do not want to pursue disciplinary actions against physicians for COVID-19 misinformation for fear of political backlash.
Michele Heisler, MD, medical director of Physicians for Human Rights, agreed that the Tennessee situation highlights the looming political threat to the independence of state medical boards. She urged other medical organizations, particularly medical specialty boards, to step in.
“As a profession, we need to take a stance against this,” said Heisler, who’s a professor of internal medicine and public health at the University of Michigan. “Our credibility as physicians is at stake.”
A version of this article first appeared on Medscape.com.
Under pressure from Republican state lawmakers, t
The board’s 7-3 vote on December 7 to delete the statement followed repeated threats by a powerful state House Republican to dissolve the board and appoint all new members if it did not immediately take it down.
The Tennessee board’s statement was a verbatim restatement of a warning to physicians issued by the Federation of State Medical Boards in July. The federation cited a “dramatic increase” in dissemination of misinformation and disinformation about the COVID-19 vaccine by physicians. It said that’s dangerous because physicians enjoy a high degree of public credibility.
Across the country, state medical licensing boards and state and national medical associations and specialty boards are struggling with how to respond to scientifically baseless public statements about COVID-19 by some physicians, which they say are increasing public confusion, political conflict, and preventable illnesses and deaths.
There have been only a small number of disciplinary actions by medical boards against physicians for spreading false COVID-19 information. Critics say the boards have been weak in responding to these dangerous violations of medical standards. As an example, they cite the State Medical Board of Ohio’s September renewal of the medical license of Sherri Tenpenny, DO, who had previously testified before Ohio lawmakers that COVID-19 vaccines magnetize their recipients and “interface” with cell phone towers.
“I’m not satisfied with what medical boards have done, and we are ramping up our efforts to press the boards to hold these physicians accountable,” said Nick Sawyer, MD, an emergency physician in Sacramento, Calif., who heads a group of healthcare professionals called No License for Disinformation.
Still, Tennessee board members insisted that the board’s policy of disciplining physicians who disseminate false information about COVID-19 vaccinations remains in effect, because state law empowers the board to take action against doctors whose unprofessional behavior endangers the public.
“COVID misinformation and disinformation has caused undue loss of life and jobs and other incalculable loss in our society,” said Melanie Blake, MD, MBA, a Chattanooga internist who’s president of the board. “Physicians have a responsibility to uphold their oath and put forward consensus-driven medical principles.”
But state Rep. John Ragan, the Republican co-chairman of the Joint Government Operations Committee, told the Tennessean newspaper that deleting the statement from the board’s website was equivalent to rescinding the policy. Ragan, who identifies himself as a business consultant and retired Air Force pilot, did not respond to a request for comment for this article.
Blake acknowledged that removing the statement from the board’s website has the potential to confuse Tennessee physicians. And the pressure from GOP lawmakers, who overwhelmingly control the Tennessee legislature, could discourage investigations and disciplinary actions against physicians who allegedly spread COVID-19 misinformation, she added. “It’s hard for me to answer whether this puts a chill on us,” she said.
In September, the Tennessee board, besides approving the general statement that physicians who spread COVID-19 disinformation could face licensure action, also directed the State Department of Health to prioritize investigations of physicians who spread outrageous claims. The board cited statements such as the vaccines are poisonous, cause infertility, contain microchips, or magnetize the body.
In response, the Tennessee General Assembly passed a bill in late October prohibiting the board from implementing any disciplinary process regarding the prescribing of “medication for COVID-19” without review and approval by Ragan’s committee. It’s not clear whether that language covers vaccines.
Last summer, in a similar move, Ragan threatened to dissolve the State Department of Health because its top vaccination official wrote a letter to medical providers explaining that state law allowed them to give COVID-19 vaccinations to minors older than 14 without parental consent. That official, Michelle Fiscus, MD, was fired in July.
Republican Sen. Richard Briggs, MD, a cardiothoracic surgeon who voted against the October legislation affecting COVID-related disciplinary actions, criticized his GOP colleagues’ interference in the medical board’s licensure decisions. “The mission of the board is to protect the health and safety of Tennessee citizens, and this was in complete conflict with that mission,” he said.
The Federation of State Medical Boards similarly condemned the Tennessee lawmakers’ moves. “The FSMB strongly opposes restricting a board’s authority to evaluate the standard of care and assess potential risk for patient harm,” a spokesman said. “Any interference, politically motivated or otherwise, is unhelpful and dangerous.”
But Arthur Caplan, PhD, a professor of bioethics at NYU School of Medicine, doubts that state medical boards are up to the task of policing disinformation spread by physicians. That’s because they ultimately are under the control of elected state officials, who may force the boards to base policy on ideology rather than science.
He said medical board members in Florida and another GOP-controlled state have told him they do not want to pursue disciplinary actions against physicians for COVID-19 misinformation for fear of political backlash.
Michele Heisler, MD, medical director of Physicians for Human Rights, agreed that the Tennessee situation highlights the looming political threat to the independence of state medical boards. She urged other medical organizations, particularly medical specialty boards, to step in.
“As a profession, we need to take a stance against this,” said Heisler, who’s a professor of internal medicine and public health at the University of Michigan. “Our credibility as physicians is at stake.”
A version of this article first appeared on Medscape.com.
AMA, hospital group sue federal government over surprise billing law
which tilts toward using prevailing rates paid for services.
The American Hospital Association and American Medical Association said they will ask the U.S. District Court for the District of Columbia to try to prevent implementation of certain provisions of new federal rules on surprise bills. This court is often a venue for fights over federal rules. Also joining the suit are Nevada-based Renown Health, UMass Memorial Health, and two physicians based in North Carolina, AHA and AMA said.
Federal agencies, including the Department of Health & Human Services, in September had unveiled the rule on surprise medical bills that will take effect Jan. 1.
Under this rule, a key benchmark for payment disputes would be the qualifying payment amount (QPA), which is pegged to median contracted rates. In the dispute-resolution process outlined in the rule, there is a presumption that the QPA is the appropriate out-of-network rate.
The rule allows for exceptions in which the independent mediating organization handling the payment dispute resolution has “credible information” as to why the QPA is materially different from the appropriate out-of-network rate.
In the view of the federal agencies that issued the rule, this approach “encourages predictable outcomes,” which likely would reduce the number of disputes that go through the resolution process while also “providing equitable and clear standards” for cases to appropriately deviate from QPA. HHS was joined in issuing the rule by the Treasury and Labor Departments and the Office of Personnel Management.
AMA and AHA disagree with their view, seeing this approach as a boon for insurers at the expense of physicians and hospitals.
In a press release, they said the rule’s approach to surprise billing would “all but ensure that hospitals, physicians, and other providers will routinely be undercompensated by commercial insurers, and patients will have fewer choices for access to in-network services.”
The rule is part of the implementation of a federal law passed in December 2020, known as the No Surprises Act. In their statement, AHA and AMA said their legal challenge would not prevent “core patient protections’’ of that law from moving forward.
“No patient should fear receiving a surprise medical bill,” Rick Pollack, AHA president and chief executive, said in the statement. “That is why hospitals and health systems supported the No Surprises Act to protect patients and keep them out of the middle of disputes between providers and insurers. Congress carefully crafted the law with a balanced, patient-friendly approach and it should be implemented as intended.”
AMA President Gerald E. Harmon, MD, added the approach used in the rule on surprise billing could create “an unsustainable situation for physicians.”
“Our legal challenge urges regulators to ensure there is a fair and meaningful process to resolve disputes between health care providers and insurance companies,” Dr. Harmon said.
AHA and AMA included with their statement a link to a November letter from more than 150 members of Congress, who also objected to the approach taken in designing the independent dispute-resolution (IDR) process.
“This directive establishes a de facto benchmark rate, making the median in-network rate the default factor considered in the IDR process. This approach is contrary to statute and could incentivize insurance companies to set artificially low payment rates, which would narrow provider networks and jeopardize patient access to care – the exact opposite of the goal of the law,” wrote the members of Congress, including Rep. Raul Ruiz, MD, a California Democrat, and Rep. Larry Bucshon, MD, an Indiana Republican.
A version of this article first appeared on Medscape.com.
which tilts toward using prevailing rates paid for services.
The American Hospital Association and American Medical Association said they will ask the U.S. District Court for the District of Columbia to try to prevent implementation of certain provisions of new federal rules on surprise bills. This court is often a venue for fights over federal rules. Also joining the suit are Nevada-based Renown Health, UMass Memorial Health, and two physicians based in North Carolina, AHA and AMA said.
Federal agencies, including the Department of Health & Human Services, in September had unveiled the rule on surprise medical bills that will take effect Jan. 1.
Under this rule, a key benchmark for payment disputes would be the qualifying payment amount (QPA), which is pegged to median contracted rates. In the dispute-resolution process outlined in the rule, there is a presumption that the QPA is the appropriate out-of-network rate.
The rule allows for exceptions in which the independent mediating organization handling the payment dispute resolution has “credible information” as to why the QPA is materially different from the appropriate out-of-network rate.
In the view of the federal agencies that issued the rule, this approach “encourages predictable outcomes,” which likely would reduce the number of disputes that go through the resolution process while also “providing equitable and clear standards” for cases to appropriately deviate from QPA. HHS was joined in issuing the rule by the Treasury and Labor Departments and the Office of Personnel Management.
AMA and AHA disagree with their view, seeing this approach as a boon for insurers at the expense of physicians and hospitals.
In a press release, they said the rule’s approach to surprise billing would “all but ensure that hospitals, physicians, and other providers will routinely be undercompensated by commercial insurers, and patients will have fewer choices for access to in-network services.”
The rule is part of the implementation of a federal law passed in December 2020, known as the No Surprises Act. In their statement, AHA and AMA said their legal challenge would not prevent “core patient protections’’ of that law from moving forward.
“No patient should fear receiving a surprise medical bill,” Rick Pollack, AHA president and chief executive, said in the statement. “That is why hospitals and health systems supported the No Surprises Act to protect patients and keep them out of the middle of disputes between providers and insurers. Congress carefully crafted the law with a balanced, patient-friendly approach and it should be implemented as intended.”
AMA President Gerald E. Harmon, MD, added the approach used in the rule on surprise billing could create “an unsustainable situation for physicians.”
“Our legal challenge urges regulators to ensure there is a fair and meaningful process to resolve disputes between health care providers and insurance companies,” Dr. Harmon said.
AHA and AMA included with their statement a link to a November letter from more than 150 members of Congress, who also objected to the approach taken in designing the independent dispute-resolution (IDR) process.
“This directive establishes a de facto benchmark rate, making the median in-network rate the default factor considered in the IDR process. This approach is contrary to statute and could incentivize insurance companies to set artificially low payment rates, which would narrow provider networks and jeopardize patient access to care – the exact opposite of the goal of the law,” wrote the members of Congress, including Rep. Raul Ruiz, MD, a California Democrat, and Rep. Larry Bucshon, MD, an Indiana Republican.
A version of this article first appeared on Medscape.com.
which tilts toward using prevailing rates paid for services.
The American Hospital Association and American Medical Association said they will ask the U.S. District Court for the District of Columbia to try to prevent implementation of certain provisions of new federal rules on surprise bills. This court is often a venue for fights over federal rules. Also joining the suit are Nevada-based Renown Health, UMass Memorial Health, and two physicians based in North Carolina, AHA and AMA said.
Federal agencies, including the Department of Health & Human Services, in September had unveiled the rule on surprise medical bills that will take effect Jan. 1.
Under this rule, a key benchmark for payment disputes would be the qualifying payment amount (QPA), which is pegged to median contracted rates. In the dispute-resolution process outlined in the rule, there is a presumption that the QPA is the appropriate out-of-network rate.
The rule allows for exceptions in which the independent mediating organization handling the payment dispute resolution has “credible information” as to why the QPA is materially different from the appropriate out-of-network rate.
In the view of the federal agencies that issued the rule, this approach “encourages predictable outcomes,” which likely would reduce the number of disputes that go through the resolution process while also “providing equitable and clear standards” for cases to appropriately deviate from QPA. HHS was joined in issuing the rule by the Treasury and Labor Departments and the Office of Personnel Management.
AMA and AHA disagree with their view, seeing this approach as a boon for insurers at the expense of physicians and hospitals.
In a press release, they said the rule’s approach to surprise billing would “all but ensure that hospitals, physicians, and other providers will routinely be undercompensated by commercial insurers, and patients will have fewer choices for access to in-network services.”
The rule is part of the implementation of a federal law passed in December 2020, known as the No Surprises Act. In their statement, AHA and AMA said their legal challenge would not prevent “core patient protections’’ of that law from moving forward.
“No patient should fear receiving a surprise medical bill,” Rick Pollack, AHA president and chief executive, said in the statement. “That is why hospitals and health systems supported the No Surprises Act to protect patients and keep them out of the middle of disputes between providers and insurers. Congress carefully crafted the law with a balanced, patient-friendly approach and it should be implemented as intended.”
AMA President Gerald E. Harmon, MD, added the approach used in the rule on surprise billing could create “an unsustainable situation for physicians.”
“Our legal challenge urges regulators to ensure there is a fair and meaningful process to resolve disputes between health care providers and insurance companies,” Dr. Harmon said.
AHA and AMA included with their statement a link to a November letter from more than 150 members of Congress, who also objected to the approach taken in designing the independent dispute-resolution (IDR) process.
“This directive establishes a de facto benchmark rate, making the median in-network rate the default factor considered in the IDR process. This approach is contrary to statute and could incentivize insurance companies to set artificially low payment rates, which would narrow provider networks and jeopardize patient access to care – the exact opposite of the goal of the law,” wrote the members of Congress, including Rep. Raul Ruiz, MD, a California Democrat, and Rep. Larry Bucshon, MD, an Indiana Republican.
A version of this article first appeared on Medscape.com.
Risk for severe COVID-19 and death plummets with Pfizer booster
Both studies were completed before the advent of the Omicron variant.
In one study that included data on more than 4 million patients, led by Yinon M. Bar-On, MSc, of the Weizmann Institute of Science in Rehovot, Israel, the rate of confirmed SARS-CoV-2 infection was lower in the booster group than in the nonbooster group by a factor of about 10.
This was true across all five age groups studied (range among the groups [starting with age 16], 9.0-17.2).
The risk for severe COVID-19 in the primary analysis decreased in the booster group by a factor of 17.9 (95% confidence interval, 15.1-21.2), among those aged 60 years or older. Risk for severe illness in those ages 40-59 was lower by a factor of 21.7 (95% CI, 10.6-44.2).
Among the 60 and older age group, risk for death was also reduced by a factor of 14.7 (95% CI, 10.0-21.4).
Researchers analyzed data for the period from July 30 to Oct. 10, 2021, from the Israel Ministry of Health database on 4.69 million people at least 16 years old who had received two Pfizer doses at least 5 months earlier.
In the main analysis, the researchers compared the rates of confirmed COVID-19, severe disease, and death among those who had gotten a booster at least 12 days earlier with the rates in a nonbooster group.
The authors wrote: “Booster vaccination programs may provide a way to control transmission without costly social-distancing measures and quarantines. Our findings provide evidence for the short-term effectiveness of the booster dose against the currently dominant Delta variant in persons 16 years of age or older.”
Death risk down by 90%
A second study, led by Ronen Arbel, PhD, with the community medical services division, Clalit Health Services (CHS), Tel Aviv, which included more than 800,000 participants, also found mortality risk was greatly reduced among those who received the booster compared with those who didn’t get the booster.
Participants aged 50 years or older who received a booster at least 5 months after a second Pfizer dose had 90% lower mortality risk because of COVID-19 than participants who did not get the booster.
The adjusted hazard ratio for death as a result of COVID-19 in the booster group, as compared with the nonbooster group, was 0.10 (95% CI, 0.07-0.14; P < .001). Of the 843,208 eligible participants, 758,118 (90%) received the booster during the 54-day study period.
The study included all CHS members who were aged 50 years or older on the study start date and had received two Pfizer doses at least 5 months earlier. CHS covers about 52% of the Israeli population and is the largest of four health care organizations in Israel that provide mandatory health care.
The authors noted that, although the study period was only 54 days (Aug. 6–Sept. 29), during that time “the incidence of COVID-19 in Israel was one of the highest in the world.”
The authors of both original articles pointed out that the studies are limited by short time periods and that longer-term studies are needed to see how the booster shots stand up to known and future variants, such as Omicron.
None of the authors involved in both studies reported relevant financial relationships.
A version of this article first appeared on Medscape.com.
Both studies were completed before the advent of the Omicron variant.
In one study that included data on more than 4 million patients, led by Yinon M. Bar-On, MSc, of the Weizmann Institute of Science in Rehovot, Israel, the rate of confirmed SARS-CoV-2 infection was lower in the booster group than in the nonbooster group by a factor of about 10.
This was true across all five age groups studied (range among the groups [starting with age 16], 9.0-17.2).
The risk for severe COVID-19 in the primary analysis decreased in the booster group by a factor of 17.9 (95% confidence interval, 15.1-21.2), among those aged 60 years or older. Risk for severe illness in those ages 40-59 was lower by a factor of 21.7 (95% CI, 10.6-44.2).
Among the 60 and older age group, risk for death was also reduced by a factor of 14.7 (95% CI, 10.0-21.4).
Researchers analyzed data for the period from July 30 to Oct. 10, 2021, from the Israel Ministry of Health database on 4.69 million people at least 16 years old who had received two Pfizer doses at least 5 months earlier.
In the main analysis, the researchers compared the rates of confirmed COVID-19, severe disease, and death among those who had gotten a booster at least 12 days earlier with the rates in a nonbooster group.
The authors wrote: “Booster vaccination programs may provide a way to control transmission without costly social-distancing measures and quarantines. Our findings provide evidence for the short-term effectiveness of the booster dose against the currently dominant Delta variant in persons 16 years of age or older.”
Death risk down by 90%
A second study, led by Ronen Arbel, PhD, with the community medical services division, Clalit Health Services (CHS), Tel Aviv, which included more than 800,000 participants, also found mortality risk was greatly reduced among those who received the booster compared with those who didn’t get the booster.
Participants aged 50 years or older who received a booster at least 5 months after a second Pfizer dose had 90% lower mortality risk because of COVID-19 than participants who did not get the booster.
The adjusted hazard ratio for death as a result of COVID-19 in the booster group, as compared with the nonbooster group, was 0.10 (95% CI, 0.07-0.14; P < .001). Of the 843,208 eligible participants, 758,118 (90%) received the booster during the 54-day study period.
The study included all CHS members who were aged 50 years or older on the study start date and had received two Pfizer doses at least 5 months earlier. CHS covers about 52% of the Israeli population and is the largest of four health care organizations in Israel that provide mandatory health care.
The authors noted that, although the study period was only 54 days (Aug. 6–Sept. 29), during that time “the incidence of COVID-19 in Israel was one of the highest in the world.”
The authors of both original articles pointed out that the studies are limited by short time periods and that longer-term studies are needed to see how the booster shots stand up to known and future variants, such as Omicron.
None of the authors involved in both studies reported relevant financial relationships.
A version of this article first appeared on Medscape.com.
Both studies were completed before the advent of the Omicron variant.
In one study that included data on more than 4 million patients, led by Yinon M. Bar-On, MSc, of the Weizmann Institute of Science in Rehovot, Israel, the rate of confirmed SARS-CoV-2 infection was lower in the booster group than in the nonbooster group by a factor of about 10.
This was true across all five age groups studied (range among the groups [starting with age 16], 9.0-17.2).
The risk for severe COVID-19 in the primary analysis decreased in the booster group by a factor of 17.9 (95% confidence interval, 15.1-21.2), among those aged 60 years or older. Risk for severe illness in those ages 40-59 was lower by a factor of 21.7 (95% CI, 10.6-44.2).
Among the 60 and older age group, risk for death was also reduced by a factor of 14.7 (95% CI, 10.0-21.4).
Researchers analyzed data for the period from July 30 to Oct. 10, 2021, from the Israel Ministry of Health database on 4.69 million people at least 16 years old who had received two Pfizer doses at least 5 months earlier.
In the main analysis, the researchers compared the rates of confirmed COVID-19, severe disease, and death among those who had gotten a booster at least 12 days earlier with the rates in a nonbooster group.
The authors wrote: “Booster vaccination programs may provide a way to control transmission without costly social-distancing measures and quarantines. Our findings provide evidence for the short-term effectiveness of the booster dose against the currently dominant Delta variant in persons 16 years of age or older.”
Death risk down by 90%
A second study, led by Ronen Arbel, PhD, with the community medical services division, Clalit Health Services (CHS), Tel Aviv, which included more than 800,000 participants, also found mortality risk was greatly reduced among those who received the booster compared with those who didn’t get the booster.
Participants aged 50 years or older who received a booster at least 5 months after a second Pfizer dose had 90% lower mortality risk because of COVID-19 than participants who did not get the booster.
The adjusted hazard ratio for death as a result of COVID-19 in the booster group, as compared with the nonbooster group, was 0.10 (95% CI, 0.07-0.14; P < .001). Of the 843,208 eligible participants, 758,118 (90%) received the booster during the 54-day study period.
The study included all CHS members who were aged 50 years or older on the study start date and had received two Pfizer doses at least 5 months earlier. CHS covers about 52% of the Israeli population and is the largest of four health care organizations in Israel that provide mandatory health care.
The authors noted that, although the study period was only 54 days (Aug. 6–Sept. 29), during that time “the incidence of COVID-19 in Israel was one of the highest in the world.”
The authors of both original articles pointed out that the studies are limited by short time periods and that longer-term studies are needed to see how the booster shots stand up to known and future variants, such as Omicron.
None of the authors involved in both studies reported relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
Underinsurance rises among U.S. children
The proportion of U.S. children who are underinsured for health care increased by 3.4% from 2016 to 2019, reflecting approximately 2.4 million underinsured children, based on data from the National Survey of Children’s Health.
Children with inconsistent or inadequate medical coverage are more likely to forgo medical care, including preventive well-child visits, and to have unmet medical needs such as prescription medications, Justin Yu, MD, of the Children’s Hospital of Pittsburgh, and colleagues wrote. Although the American Academy of Pediatrics and the Healthy People 2030 guidelines have endorsed increasing the proportion of children with adequate coverage, recent studies suggest that advances in insuring children in the wake of the Affordable Care Act have stalled, and trends in child insurance have not been well described, the researchers said.
In a study published in Pediatrics, the researchers reviewed data from the combined 2016-2019 datasets of the National Survey of Children’s Health, a survey funded by the Maternal and Child Health Bureau of the Health Resources and Services Administration.
Adequate insurance was defined as a composite with three questions; whether the benefits “usually” or “always” meet the child’s needs; the benefits “usually” or “always” allow the child to see needed providers; and whether out-of-pocket expenses are either absent or “usually” or “always” reasonable.
Overall, the proportion of children with underinsurance increased from 30.6% in 2016 to 34.0% in 2019.
Underinsurance was significantly associated with increased health complexity and private insurance, with adjusted odds ratios of 1.9 and 3.5, respectively. In addition, underinsurance was significantly associated with child age of 6 years or older, non-Black racial identity, U.S. nonnative status, and a family income of at least 100% above the Federal Poverty Level. Notably, underinsurance grew significantly among White children living in “middle-income” families, the researchers said.
The increase in underinsurance was driven primarily by increased insurance inadequacy, which rose from 24.8% to 27.9% over the study period. The increase in insurance inadequacy was described primarily as unreasonable out-of-pocket medical expenses, according to the survey respondents.
The study findings were limited by several factors including the inability to show causality or to describe changes in outcomes for individual children, the researchers noted. Other limitations include the reliance on parent reports and the lack of a definitive definition of underinsurance.
However, the results highlight the ongoing problem of underinsurance in children, and the need to address the factors that contribute to inadequate insurance for children, the researchers said.
“Our data, demonstrating a shift from public to private insurance that is more likely to be inadequate, in conjunction with existing literature linking Medicaid/CHIP [Children’s Health Insurance Program] coverage with improved access to medical care as well as improved long-term outcomes in adulthood, should give policy makers and payers pause as they contemplate strategies to improve child health,” they concluded.
Nationwide action needed to fight underinsurance
The authors should be commended for highlighting the disturbing trend in underinsurance among children in the United States, Tim Joos, MD, a Seattle-based clinician with a combination internal medicine/pediatrics practice, said in an interview.
“With the passage of the Affordable Care Act, the population of uninsured and underinsured had shrunk quite a bit, but in the past few years, the numbers are growing again. This population has often been called the working poor; the vast majority are legal residents who make too much to qualify for Medicaid/CHIP programs, and whose employers don’t offer affordable robust health care coverage,” Dr. Joos said.
“These families have to make the risky decisions of how much of the family budget to spend on insurance plans, often to the detriment of their own and their children’s health,” he explained. “If you believe the old adage about ‘an ounce of prevention,’ then the money we spend on preserving the health of our children will more than pay for itself in benefits of increased productivity and health care savings in the 1-2 decades later when they reach adulthood. It is time for us as a nation to come up with a more comprehensive baseline coverage for all pediatric patients and take away any barriers for families to access basic health care for children.”
The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Joos had no financial conflicts to disclose and serves on the editorial advisory board of Pediatric News.
The proportion of U.S. children who are underinsured for health care increased by 3.4% from 2016 to 2019, reflecting approximately 2.4 million underinsured children, based on data from the National Survey of Children’s Health.
Children with inconsistent or inadequate medical coverage are more likely to forgo medical care, including preventive well-child visits, and to have unmet medical needs such as prescription medications, Justin Yu, MD, of the Children’s Hospital of Pittsburgh, and colleagues wrote. Although the American Academy of Pediatrics and the Healthy People 2030 guidelines have endorsed increasing the proportion of children with adequate coverage, recent studies suggest that advances in insuring children in the wake of the Affordable Care Act have stalled, and trends in child insurance have not been well described, the researchers said.
In a study published in Pediatrics, the researchers reviewed data from the combined 2016-2019 datasets of the National Survey of Children’s Health, a survey funded by the Maternal and Child Health Bureau of the Health Resources and Services Administration.
Adequate insurance was defined as a composite with three questions; whether the benefits “usually” or “always” meet the child’s needs; the benefits “usually” or “always” allow the child to see needed providers; and whether out-of-pocket expenses are either absent or “usually” or “always” reasonable.
Overall, the proportion of children with underinsurance increased from 30.6% in 2016 to 34.0% in 2019.
Underinsurance was significantly associated with increased health complexity and private insurance, with adjusted odds ratios of 1.9 and 3.5, respectively. In addition, underinsurance was significantly associated with child age of 6 years or older, non-Black racial identity, U.S. nonnative status, and a family income of at least 100% above the Federal Poverty Level. Notably, underinsurance grew significantly among White children living in “middle-income” families, the researchers said.
The increase in underinsurance was driven primarily by increased insurance inadequacy, which rose from 24.8% to 27.9% over the study period. The increase in insurance inadequacy was described primarily as unreasonable out-of-pocket medical expenses, according to the survey respondents.
The study findings were limited by several factors including the inability to show causality or to describe changes in outcomes for individual children, the researchers noted. Other limitations include the reliance on parent reports and the lack of a definitive definition of underinsurance.
However, the results highlight the ongoing problem of underinsurance in children, and the need to address the factors that contribute to inadequate insurance for children, the researchers said.
“Our data, demonstrating a shift from public to private insurance that is more likely to be inadequate, in conjunction with existing literature linking Medicaid/CHIP [Children’s Health Insurance Program] coverage with improved access to medical care as well as improved long-term outcomes in adulthood, should give policy makers and payers pause as they contemplate strategies to improve child health,” they concluded.
Nationwide action needed to fight underinsurance
The authors should be commended for highlighting the disturbing trend in underinsurance among children in the United States, Tim Joos, MD, a Seattle-based clinician with a combination internal medicine/pediatrics practice, said in an interview.
“With the passage of the Affordable Care Act, the population of uninsured and underinsured had shrunk quite a bit, but in the past few years, the numbers are growing again. This population has often been called the working poor; the vast majority are legal residents who make too much to qualify for Medicaid/CHIP programs, and whose employers don’t offer affordable robust health care coverage,” Dr. Joos said.
“These families have to make the risky decisions of how much of the family budget to spend on insurance plans, often to the detriment of their own and their children’s health,” he explained. “If you believe the old adage about ‘an ounce of prevention,’ then the money we spend on preserving the health of our children will more than pay for itself in benefits of increased productivity and health care savings in the 1-2 decades later when they reach adulthood. It is time for us as a nation to come up with a more comprehensive baseline coverage for all pediatric patients and take away any barriers for families to access basic health care for children.”
The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Joos had no financial conflicts to disclose and serves on the editorial advisory board of Pediatric News.
The proportion of U.S. children who are underinsured for health care increased by 3.4% from 2016 to 2019, reflecting approximately 2.4 million underinsured children, based on data from the National Survey of Children’s Health.
Children with inconsistent or inadequate medical coverage are more likely to forgo medical care, including preventive well-child visits, and to have unmet medical needs such as prescription medications, Justin Yu, MD, of the Children’s Hospital of Pittsburgh, and colleagues wrote. Although the American Academy of Pediatrics and the Healthy People 2030 guidelines have endorsed increasing the proportion of children with adequate coverage, recent studies suggest that advances in insuring children in the wake of the Affordable Care Act have stalled, and trends in child insurance have not been well described, the researchers said.
In a study published in Pediatrics, the researchers reviewed data from the combined 2016-2019 datasets of the National Survey of Children’s Health, a survey funded by the Maternal and Child Health Bureau of the Health Resources and Services Administration.
Adequate insurance was defined as a composite with three questions; whether the benefits “usually” or “always” meet the child’s needs; the benefits “usually” or “always” allow the child to see needed providers; and whether out-of-pocket expenses are either absent or “usually” or “always” reasonable.
Overall, the proportion of children with underinsurance increased from 30.6% in 2016 to 34.0% in 2019.
Underinsurance was significantly associated with increased health complexity and private insurance, with adjusted odds ratios of 1.9 and 3.5, respectively. In addition, underinsurance was significantly associated with child age of 6 years or older, non-Black racial identity, U.S. nonnative status, and a family income of at least 100% above the Federal Poverty Level. Notably, underinsurance grew significantly among White children living in “middle-income” families, the researchers said.
The increase in underinsurance was driven primarily by increased insurance inadequacy, which rose from 24.8% to 27.9% over the study period. The increase in insurance inadequacy was described primarily as unreasonable out-of-pocket medical expenses, according to the survey respondents.
The study findings were limited by several factors including the inability to show causality or to describe changes in outcomes for individual children, the researchers noted. Other limitations include the reliance on parent reports and the lack of a definitive definition of underinsurance.
However, the results highlight the ongoing problem of underinsurance in children, and the need to address the factors that contribute to inadequate insurance for children, the researchers said.
“Our data, demonstrating a shift from public to private insurance that is more likely to be inadequate, in conjunction with existing literature linking Medicaid/CHIP [Children’s Health Insurance Program] coverage with improved access to medical care as well as improved long-term outcomes in adulthood, should give policy makers and payers pause as they contemplate strategies to improve child health,” they concluded.
Nationwide action needed to fight underinsurance
The authors should be commended for highlighting the disturbing trend in underinsurance among children in the United States, Tim Joos, MD, a Seattle-based clinician with a combination internal medicine/pediatrics practice, said in an interview.
“With the passage of the Affordable Care Act, the population of uninsured and underinsured had shrunk quite a bit, but in the past few years, the numbers are growing again. This population has often been called the working poor; the vast majority are legal residents who make too much to qualify for Medicaid/CHIP programs, and whose employers don’t offer affordable robust health care coverage,” Dr. Joos said.
“These families have to make the risky decisions of how much of the family budget to spend on insurance plans, often to the detriment of their own and their children’s health,” he explained. “If you believe the old adage about ‘an ounce of prevention,’ then the money we spend on preserving the health of our children will more than pay for itself in benefits of increased productivity and health care savings in the 1-2 decades later when they reach adulthood. It is time for us as a nation to come up with a more comprehensive baseline coverage for all pediatric patients and take away any barriers for families to access basic health care for children.”
The study received no outside funding. The researchers had no financial conflicts to disclose. Dr. Joos had no financial conflicts to disclose and serves on the editorial advisory board of Pediatric News.
FROM PEDIATRICS
Mumps: Sometimes forgotten but not gone
The 7-year-old boy sat at the edge of a stretcher in the emergency department, looking miserable, as his mother recounted his symptoms to a senior resident physician on duty. Low-grade fever, fatigue, and myalgias prompted rapid SARS-CoV-2 testing at his school. That test, as well as a repeat test at the pediatrician’s office, were negative. A triage protocol in the emergency department prompted a third test, which was also negative.
“Everyone has told me that it’s likely just a different virus,” the mother said. “But then his cheek started to swell. Have you ever seen anything like this?”
The boy turned his head, revealing a diffuse swelling that extended down his right cheek to the angle of his jaw.
“Only in textbooks,” the resident physician responded.
It is a credit to our national immunization program that most practicing clinicians have never actually seen a case of mumps. Before vaccination was introduced in 1967, infection in childhood was nearly universal. Unilateral or bilateral tender swelling of the parotid gland is the typical clinical finding. Low-grade fever, myalgias, decreased appetite, malaise, and headache may precede parotid swelling in some patients. Other patients infected with mumps may have only respiratory symptoms, and some may have no symptoms at all.
Two doses of measles-mumps-rubella vaccine have been recommended for children in the United States since 1989, with the first dose administered at 12-15 months of age. According to data collected through the National Immunization Survey, more than 92% of children in the United States receive at least one dose of measles-mumps-rubella vaccine by 24 months of age. The vaccine is immunogenic, with 94% of recipients developing measurable mumps antibody (range, 89%-97%). The vaccine has been a public health success: Overall, mumps cases declined more than 99% between 1967 and 2005.
But in the mid-2000s, mumps cases started to rise again, with more than 28,000 reported between 2007 and 2019. Annual cases ranged from 229 to 6,369 and while large, localized outbreaks have contributed to peak years, mumps has been reported from all 50 states and the District of Columbia. According to a recently published paper in Pediatrics, nearly a third of these cases occurred in children <18 years of age and most had been appropriately immunized for age.
Of the 9,172 cases reported in children, 5,461 or 60% occurred between 2015 and 2019. Of these, 55% were in boys. While cases occurred in children of all ages, 54% were in children 11-17 years of age, and 33% were in children 5-10 years of age. Non-Hispanic Asian and/or Pacific Islander children accounted for 38% of cases. Only 2% of cases were associated with international travel and were presumed to have been acquired outside the United States
The reason for the increase in mumps cases in recent years is not well understood. Outbreaks in fully immunized college students have prompted concern about poor B-cell memory after vaccination resulting in waning immunity over time. In the past, antibodies against mumps were boosted by exposure to wild-type mumps virus but such exposures have become fortunately rare for most of us. Cases in recently immunized children suggest there is more to the story. Notably, there is a mismatch between the genotype A mumps virus contained in the current MMR and MMRV vaccines and the genotype G virus currently circulating in the United States.
With the onset of the pandemic and implementation of mitigation measures to prevent the spread of COVID-19, circulation of some common respiratory viruses, including respiratory syncytial virus and influenza, was sharply curtailed. Mumps continued to circulate, albeit at reduced levels, with 616 cases reported in 2020. In 2021, 30 states and jurisdictions reported 139 cases through Dec. 1.
Clinicians should suspect mumps in all cases of parotitis, regardless of an individual’s age, vaccination status, or travel history. Laboratory testing is required to distinguish mumps from other infectious and noninfectious causes of parotitis. Infectious causes include gram-positive and gram-negative bacterial infection, as well as other viral infections, including Epstein-Barr virus, coxsackie viruses, parainfluenza, and rarely, influenza. Case reports also describe parotitis coincident with SARS-CoV-2 infection.
When parotitis has been present for 3 days or less, a buccal swab for RT-PCR should be obtained, massaging the parotid gland for 30 seconds before specimen collection. When parotitis has been present for >3 days, a mumps Immunoglobulin M serum antibody should be collected in addition to the buccal swab PCR. A negative IgM does not exclude the possibility of infection, especially in immunized individuals. Mumps is a nationally notifiable disease, and all confirmed and suspect cases should be reported to the state or local health department.
Back in the emergency department, the mother was counseled about the potential diagnosis of mumps and the need for her son to isolate at home for 5 days after the onset of the parotid swelling. She was also educated about potential complications of mumps, including orchitis, aseptic meningitis and encephalitis, and hearing loss. Fortunately, complications are less common in individuals who have been immunized, and orchitis rarely occurs in prepubertal boys.
The resident physician also confirmed that other members of the household had been appropriately immunized for age. While the MMR vaccine does not prevent illness in those already infected with mumps and is not indicated as postexposure prophylaxis, providing vaccine to those not already immunized can protect against future exposures. A third dose of MMR vaccine is only indicated in the setting of an outbreak and when specifically recommended by public health authorities for those deemed to be in a high-risk group. Additional information about mumps is available at www.cdc.gov/mumps/hcp.html#report.
Dr. Bryant is a pediatrician specializing in infectious diseases at the University of Louisville (Ky.) and Norton Children’s Hospital, also in Louisville. She said she had no relevant financial disclosures. Email her at [email protected].
The 7-year-old boy sat at the edge of a stretcher in the emergency department, looking miserable, as his mother recounted his symptoms to a senior resident physician on duty. Low-grade fever, fatigue, and myalgias prompted rapid SARS-CoV-2 testing at his school. That test, as well as a repeat test at the pediatrician’s office, were negative. A triage protocol in the emergency department prompted a third test, which was also negative.
“Everyone has told me that it’s likely just a different virus,” the mother said. “But then his cheek started to swell. Have you ever seen anything like this?”
The boy turned his head, revealing a diffuse swelling that extended down his right cheek to the angle of his jaw.
“Only in textbooks,” the resident physician responded.
It is a credit to our national immunization program that most practicing clinicians have never actually seen a case of mumps. Before vaccination was introduced in 1967, infection in childhood was nearly universal. Unilateral or bilateral tender swelling of the parotid gland is the typical clinical finding. Low-grade fever, myalgias, decreased appetite, malaise, and headache may precede parotid swelling in some patients. Other patients infected with mumps may have only respiratory symptoms, and some may have no symptoms at all.
Two doses of measles-mumps-rubella vaccine have been recommended for children in the United States since 1989, with the first dose administered at 12-15 months of age. According to data collected through the National Immunization Survey, more than 92% of children in the United States receive at least one dose of measles-mumps-rubella vaccine by 24 months of age. The vaccine is immunogenic, with 94% of recipients developing measurable mumps antibody (range, 89%-97%). The vaccine has been a public health success: Overall, mumps cases declined more than 99% between 1967 and 2005.
But in the mid-2000s, mumps cases started to rise again, with more than 28,000 reported between 2007 and 2019. Annual cases ranged from 229 to 6,369 and while large, localized outbreaks have contributed to peak years, mumps has been reported from all 50 states and the District of Columbia. According to a recently published paper in Pediatrics, nearly a third of these cases occurred in children <18 years of age and most had been appropriately immunized for age.
Of the 9,172 cases reported in children, 5,461 or 60% occurred between 2015 and 2019. Of these, 55% were in boys. While cases occurred in children of all ages, 54% were in children 11-17 years of age, and 33% were in children 5-10 years of age. Non-Hispanic Asian and/or Pacific Islander children accounted for 38% of cases. Only 2% of cases were associated with international travel and were presumed to have been acquired outside the United States
The reason for the increase in mumps cases in recent years is not well understood. Outbreaks in fully immunized college students have prompted concern about poor B-cell memory after vaccination resulting in waning immunity over time. In the past, antibodies against mumps were boosted by exposure to wild-type mumps virus but such exposures have become fortunately rare for most of us. Cases in recently immunized children suggest there is more to the story. Notably, there is a mismatch between the genotype A mumps virus contained in the current MMR and MMRV vaccines and the genotype G virus currently circulating in the United States.
With the onset of the pandemic and implementation of mitigation measures to prevent the spread of COVID-19, circulation of some common respiratory viruses, including respiratory syncytial virus and influenza, was sharply curtailed. Mumps continued to circulate, albeit at reduced levels, with 616 cases reported in 2020. In 2021, 30 states and jurisdictions reported 139 cases through Dec. 1.
Clinicians should suspect mumps in all cases of parotitis, regardless of an individual’s age, vaccination status, or travel history. Laboratory testing is required to distinguish mumps from other infectious and noninfectious causes of parotitis. Infectious causes include gram-positive and gram-negative bacterial infection, as well as other viral infections, including Epstein-Barr virus, coxsackie viruses, parainfluenza, and rarely, influenza. Case reports also describe parotitis coincident with SARS-CoV-2 infection.
When parotitis has been present for 3 days or less, a buccal swab for RT-PCR should be obtained, massaging the parotid gland for 30 seconds before specimen collection. When parotitis has been present for >3 days, a mumps Immunoglobulin M serum antibody should be collected in addition to the buccal swab PCR. A negative IgM does not exclude the possibility of infection, especially in immunized individuals. Mumps is a nationally notifiable disease, and all confirmed and suspect cases should be reported to the state or local health department.
Back in the emergency department, the mother was counseled about the potential diagnosis of mumps and the need for her son to isolate at home for 5 days after the onset of the parotid swelling. She was also educated about potential complications of mumps, including orchitis, aseptic meningitis and encephalitis, and hearing loss. Fortunately, complications are less common in individuals who have been immunized, and orchitis rarely occurs in prepubertal boys.
The resident physician also confirmed that other members of the household had been appropriately immunized for age. While the MMR vaccine does not prevent illness in those already infected with mumps and is not indicated as postexposure prophylaxis, providing vaccine to those not already immunized can protect against future exposures. A third dose of MMR vaccine is only indicated in the setting of an outbreak and when specifically recommended by public health authorities for those deemed to be in a high-risk group. Additional information about mumps is available at www.cdc.gov/mumps/hcp.html#report.
Dr. Bryant is a pediatrician specializing in infectious diseases at the University of Louisville (Ky.) and Norton Children’s Hospital, also in Louisville. She said she had no relevant financial disclosures. Email her at [email protected].
The 7-year-old boy sat at the edge of a stretcher in the emergency department, looking miserable, as his mother recounted his symptoms to a senior resident physician on duty. Low-grade fever, fatigue, and myalgias prompted rapid SARS-CoV-2 testing at his school. That test, as well as a repeat test at the pediatrician’s office, were negative. A triage protocol in the emergency department prompted a third test, which was also negative.
“Everyone has told me that it’s likely just a different virus,” the mother said. “But then his cheek started to swell. Have you ever seen anything like this?”
The boy turned his head, revealing a diffuse swelling that extended down his right cheek to the angle of his jaw.
“Only in textbooks,” the resident physician responded.
It is a credit to our national immunization program that most practicing clinicians have never actually seen a case of mumps. Before vaccination was introduced in 1967, infection in childhood was nearly universal. Unilateral or bilateral tender swelling of the parotid gland is the typical clinical finding. Low-grade fever, myalgias, decreased appetite, malaise, and headache may precede parotid swelling in some patients. Other patients infected with mumps may have only respiratory symptoms, and some may have no symptoms at all.
Two doses of measles-mumps-rubella vaccine have been recommended for children in the United States since 1989, with the first dose administered at 12-15 months of age. According to data collected through the National Immunization Survey, more than 92% of children in the United States receive at least one dose of measles-mumps-rubella vaccine by 24 months of age. The vaccine is immunogenic, with 94% of recipients developing measurable mumps antibody (range, 89%-97%). The vaccine has been a public health success: Overall, mumps cases declined more than 99% between 1967 and 2005.
But in the mid-2000s, mumps cases started to rise again, with more than 28,000 reported between 2007 and 2019. Annual cases ranged from 229 to 6,369 and while large, localized outbreaks have contributed to peak years, mumps has been reported from all 50 states and the District of Columbia. According to a recently published paper in Pediatrics, nearly a third of these cases occurred in children <18 years of age and most had been appropriately immunized for age.
Of the 9,172 cases reported in children, 5,461 or 60% occurred between 2015 and 2019. Of these, 55% were in boys. While cases occurred in children of all ages, 54% were in children 11-17 years of age, and 33% were in children 5-10 years of age. Non-Hispanic Asian and/or Pacific Islander children accounted for 38% of cases. Only 2% of cases were associated with international travel and were presumed to have been acquired outside the United States
The reason for the increase in mumps cases in recent years is not well understood. Outbreaks in fully immunized college students have prompted concern about poor B-cell memory after vaccination resulting in waning immunity over time. In the past, antibodies against mumps were boosted by exposure to wild-type mumps virus but such exposures have become fortunately rare for most of us. Cases in recently immunized children suggest there is more to the story. Notably, there is a mismatch between the genotype A mumps virus contained in the current MMR and MMRV vaccines and the genotype G virus currently circulating in the United States.
With the onset of the pandemic and implementation of mitigation measures to prevent the spread of COVID-19, circulation of some common respiratory viruses, including respiratory syncytial virus and influenza, was sharply curtailed. Mumps continued to circulate, albeit at reduced levels, with 616 cases reported in 2020. In 2021, 30 states and jurisdictions reported 139 cases through Dec. 1.
Clinicians should suspect mumps in all cases of parotitis, regardless of an individual’s age, vaccination status, or travel history. Laboratory testing is required to distinguish mumps from other infectious and noninfectious causes of parotitis. Infectious causes include gram-positive and gram-negative bacterial infection, as well as other viral infections, including Epstein-Barr virus, coxsackie viruses, parainfluenza, and rarely, influenza. Case reports also describe parotitis coincident with SARS-CoV-2 infection.
When parotitis has been present for 3 days or less, a buccal swab for RT-PCR should be obtained, massaging the parotid gland for 30 seconds before specimen collection. When parotitis has been present for >3 days, a mumps Immunoglobulin M serum antibody should be collected in addition to the buccal swab PCR. A negative IgM does not exclude the possibility of infection, especially in immunized individuals. Mumps is a nationally notifiable disease, and all confirmed and suspect cases should be reported to the state or local health department.
Back in the emergency department, the mother was counseled about the potential diagnosis of mumps and the need for her son to isolate at home for 5 days after the onset of the parotid swelling. She was also educated about potential complications of mumps, including orchitis, aseptic meningitis and encephalitis, and hearing loss. Fortunately, complications are less common in individuals who have been immunized, and orchitis rarely occurs in prepubertal boys.
The resident physician also confirmed that other members of the household had been appropriately immunized for age. While the MMR vaccine does not prevent illness in those already infected with mumps and is not indicated as postexposure prophylaxis, providing vaccine to those not already immunized can protect against future exposures. A third dose of MMR vaccine is only indicated in the setting of an outbreak and when specifically recommended by public health authorities for those deemed to be in a high-risk group. Additional information about mumps is available at www.cdc.gov/mumps/hcp.html#report.
Dr. Bryant is a pediatrician specializing in infectious diseases at the University of Louisville (Ky.) and Norton Children’s Hospital, also in Louisville. She said she had no relevant financial disclosures. Email her at [email protected].
Should ‘advanced maternal age’ be redefined? Study suggests benefits.
Pregnant women who were at or above the advanced maternal age (AMA) cutoff of 35 years on their due date received significantly more prenatal care, resulting in a slight decline in perinatal mortality, compared with women who were just a few months younger, according to a new study published in JAMA Health Forum. The findings “suggest that clinicians use the cutoff as a heuristic in their clinical recommendations and service provision,” noted lead author Caroline K. Geiger, PhD, who was a PhD student at Harvard University in Cambridge, Mass., during the course of the study, and now works as an associate health economist at Genentech in San Francisco. She and her coauthors suggest a slightly younger AMA cutoff might be beneficial. “Our results suggest that 3.9 perinatal deaths per 1,000 deliveries in this age range could be averted if patients just a few months younger than the AMA cutoff received similar care to those older than the cutoff,” they wrote. “Although the risk of adverse outcomes increases with maternal age, individuals 4 months older or younger than 35 years should not have different underlying risks.”
The cross-sectional study used a national sample of 51,290 commercially insured individuals who were pregnant between 2008 and 2019 and had delivery dates within 120 days of their 35th birthday. Just over half (50.9%) of the individuals were aged 34.7-34.9 years on their expected delivery date – just below the AMA cutoff – while 49.1% were just over the cutoff at age 35.0-35.3 years. A total of 4.7% had multiple gestation, 4.8% had pregestational diabetes, 4.4% had chronic hypertension, and 9.7% had obesity. There was also a subgroup analysis among individuals with low-risk pregnancy (defined as singleton, with no pregestational diabetes, chronic hypertension, or obesity) because they were less likely to have indications for additional prenatal care.
Although there was a slight, nonstatistically significant increase in the overall number of ob.gyn. visits at the AMA cutoff, compared with below it, the percentage of individuals with any maternal-fetal medicine visit increased by 4.27 percentage points (P < .001) at the cutoff. Additionally, while there was a “modest” increase in total ultrasounds (P = .006), there was a significant increase in detailed ultrasounds (P < .001) at the cutoff, and a “substantial” increase in antepartum surveillance (P < .001), the authors reported.
The AMA designation was associated with a 0.39 percentage-point decline in perinatal mortality (P = .04), “however, there were no significant changes in the proportion of individuals with severe maternal morbidity or with preterm birth or low birth weight at age 35 years,” they wrote.
In the subgroup analysis of low-risk pregnancies, “prenatal care services increased substantially at the 35-year cutoff, and in all cases, the increases at age 35 years for this group were larger than for the full sample,” they noted, adding that there was also a “substantially larger” decline in perinatal mortality at the AMA cutoff (P = .002), compared with the full sample.
The authors noted the need for more rigorous evidence on the value and effect of prenatal care guidelines on pregnancy outcomes. “Although pregnancy-related risks increase with maternal age, there is no known abrupt biological increase in underlying risk precisely at age 35 years,” they wrote, adding that “much of the content of prenatal care guidelines has persisted for decades without strong causal evidence to demonstrate its value.”
Their words echo those of Alex F. Peahl, MD, an ob.gyn. and assistant professor at the Institute for Healthcare Policy and Innovation, at the University of Michigan, in Ann Arbor, MI. In a recent review, Dr. Peahl and her colleague Joel D. Howell, MD, PhD, from the same university (Am J Obstet Gynecol. 2021 Apr;224[4]:339-47), note that the COVID-19 pandemic forced a much-needed rethink of prenatal care and its delivery. A look through the history of prenatal care shows “we have treated visit frequency and modality as fixed boxes, into which we must fit an ever-changing set of care recommendations,” they wrote. “We do not have data to support a specific prenatal visit schedule, recommended number of telemedicine visits, or specifications of additional services, and we never have. However, one thing is clear: we are long overdue for new prenatal care delivery guidelines in the United States.”
But when reached for comment on the new study Dr. Peahl cautioned that its conclusions are “limited and warrant future investigation. … While increased prenatal services may explain the improvement in outcomes, several other explanations should be considered,” she told this publication. “Perhaps, maternity care professional behavior differs for patients who are over the age of 35, resulting in increased caution in interpreting test results and symptoms; perhaps patients are more routinely induced at 39 weeks, limiting stillbirth rate; or perhaps patients are more hypervigilant when given the diagnosis of AMA.”
Priya Rajan, MD, agreed that while the paper showed an association between intensified antenatal interventions and decreased perinatal mortality, it did not show a causal relationship. “The study did not include information on other important factors that are also associated with perinatal risk,” noted Dr. Rajan, who is an associate professor in the department of ob.gyn. at Northwestern University in Chicago. Yet, she acknowledged that the findings “support what many clinicians know, which is that age 35 isn’t some tipping point; rather, obstetric risk is influenced by a range of factors, of which age may be one. This study, particularly when considered in the context of other studies and articles we have seen recently, confirms the need for us to rethink how we care for people during pregnancy and post partum. This includes delving further into understanding what aspects of the prenatal care that we provide have the biggest impact for both maternal and perinatal adverse outcomes.”
The study was supported by grant DGE1745303 from the National Science Foundation Graduate Research Fellowship Program. Dr. Geiger reported being a PhD student during the conduction of the study, but had no other disclosures. Dr. Peahl will soon be a consultant for Maven Clinic. Dr. Rajan had no relevant disclosures.
Pregnant women who were at or above the advanced maternal age (AMA) cutoff of 35 years on their due date received significantly more prenatal care, resulting in a slight decline in perinatal mortality, compared with women who were just a few months younger, according to a new study published in JAMA Health Forum. The findings “suggest that clinicians use the cutoff as a heuristic in their clinical recommendations and service provision,” noted lead author Caroline K. Geiger, PhD, who was a PhD student at Harvard University in Cambridge, Mass., during the course of the study, and now works as an associate health economist at Genentech in San Francisco. She and her coauthors suggest a slightly younger AMA cutoff might be beneficial. “Our results suggest that 3.9 perinatal deaths per 1,000 deliveries in this age range could be averted if patients just a few months younger than the AMA cutoff received similar care to those older than the cutoff,” they wrote. “Although the risk of adverse outcomes increases with maternal age, individuals 4 months older or younger than 35 years should not have different underlying risks.”
The cross-sectional study used a national sample of 51,290 commercially insured individuals who were pregnant between 2008 and 2019 and had delivery dates within 120 days of their 35th birthday. Just over half (50.9%) of the individuals were aged 34.7-34.9 years on their expected delivery date – just below the AMA cutoff – while 49.1% were just over the cutoff at age 35.0-35.3 years. A total of 4.7% had multiple gestation, 4.8% had pregestational diabetes, 4.4% had chronic hypertension, and 9.7% had obesity. There was also a subgroup analysis among individuals with low-risk pregnancy (defined as singleton, with no pregestational diabetes, chronic hypertension, or obesity) because they were less likely to have indications for additional prenatal care.
Although there was a slight, nonstatistically significant increase in the overall number of ob.gyn. visits at the AMA cutoff, compared with below it, the percentage of individuals with any maternal-fetal medicine visit increased by 4.27 percentage points (P < .001) at the cutoff. Additionally, while there was a “modest” increase in total ultrasounds (P = .006), there was a significant increase in detailed ultrasounds (P < .001) at the cutoff, and a “substantial” increase in antepartum surveillance (P < .001), the authors reported.
The AMA designation was associated with a 0.39 percentage-point decline in perinatal mortality (P = .04), “however, there were no significant changes in the proportion of individuals with severe maternal morbidity or with preterm birth or low birth weight at age 35 years,” they wrote.
In the subgroup analysis of low-risk pregnancies, “prenatal care services increased substantially at the 35-year cutoff, and in all cases, the increases at age 35 years for this group were larger than for the full sample,” they noted, adding that there was also a “substantially larger” decline in perinatal mortality at the AMA cutoff (P = .002), compared with the full sample.
The authors noted the need for more rigorous evidence on the value and effect of prenatal care guidelines on pregnancy outcomes. “Although pregnancy-related risks increase with maternal age, there is no known abrupt biological increase in underlying risk precisely at age 35 years,” they wrote, adding that “much of the content of prenatal care guidelines has persisted for decades without strong causal evidence to demonstrate its value.”
Their words echo those of Alex F. Peahl, MD, an ob.gyn. and assistant professor at the Institute for Healthcare Policy and Innovation, at the University of Michigan, in Ann Arbor, MI. In a recent review, Dr. Peahl and her colleague Joel D. Howell, MD, PhD, from the same university (Am J Obstet Gynecol. 2021 Apr;224[4]:339-47), note that the COVID-19 pandemic forced a much-needed rethink of prenatal care and its delivery. A look through the history of prenatal care shows “we have treated visit frequency and modality as fixed boxes, into which we must fit an ever-changing set of care recommendations,” they wrote. “We do not have data to support a specific prenatal visit schedule, recommended number of telemedicine visits, or specifications of additional services, and we never have. However, one thing is clear: we are long overdue for new prenatal care delivery guidelines in the United States.”
But when reached for comment on the new study Dr. Peahl cautioned that its conclusions are “limited and warrant future investigation. … While increased prenatal services may explain the improvement in outcomes, several other explanations should be considered,” she told this publication. “Perhaps, maternity care professional behavior differs for patients who are over the age of 35, resulting in increased caution in interpreting test results and symptoms; perhaps patients are more routinely induced at 39 weeks, limiting stillbirth rate; or perhaps patients are more hypervigilant when given the diagnosis of AMA.”
Priya Rajan, MD, agreed that while the paper showed an association between intensified antenatal interventions and decreased perinatal mortality, it did not show a causal relationship. “The study did not include information on other important factors that are also associated with perinatal risk,” noted Dr. Rajan, who is an associate professor in the department of ob.gyn. at Northwestern University in Chicago. Yet, she acknowledged that the findings “support what many clinicians know, which is that age 35 isn’t some tipping point; rather, obstetric risk is influenced by a range of factors, of which age may be one. This study, particularly when considered in the context of other studies and articles we have seen recently, confirms the need for us to rethink how we care for people during pregnancy and post partum. This includes delving further into understanding what aspects of the prenatal care that we provide have the biggest impact for both maternal and perinatal adverse outcomes.”
The study was supported by grant DGE1745303 from the National Science Foundation Graduate Research Fellowship Program. Dr. Geiger reported being a PhD student during the conduction of the study, but had no other disclosures. Dr. Peahl will soon be a consultant for Maven Clinic. Dr. Rajan had no relevant disclosures.
Pregnant women who were at or above the advanced maternal age (AMA) cutoff of 35 years on their due date received significantly more prenatal care, resulting in a slight decline in perinatal mortality, compared with women who were just a few months younger, according to a new study published in JAMA Health Forum. The findings “suggest that clinicians use the cutoff as a heuristic in their clinical recommendations and service provision,” noted lead author Caroline K. Geiger, PhD, who was a PhD student at Harvard University in Cambridge, Mass., during the course of the study, and now works as an associate health economist at Genentech in San Francisco. She and her coauthors suggest a slightly younger AMA cutoff might be beneficial. “Our results suggest that 3.9 perinatal deaths per 1,000 deliveries in this age range could be averted if patients just a few months younger than the AMA cutoff received similar care to those older than the cutoff,” they wrote. “Although the risk of adverse outcomes increases with maternal age, individuals 4 months older or younger than 35 years should not have different underlying risks.”
The cross-sectional study used a national sample of 51,290 commercially insured individuals who were pregnant between 2008 and 2019 and had delivery dates within 120 days of their 35th birthday. Just over half (50.9%) of the individuals were aged 34.7-34.9 years on their expected delivery date – just below the AMA cutoff – while 49.1% were just over the cutoff at age 35.0-35.3 years. A total of 4.7% had multiple gestation, 4.8% had pregestational diabetes, 4.4% had chronic hypertension, and 9.7% had obesity. There was also a subgroup analysis among individuals with low-risk pregnancy (defined as singleton, with no pregestational diabetes, chronic hypertension, or obesity) because they were less likely to have indications for additional prenatal care.
Although there was a slight, nonstatistically significant increase in the overall number of ob.gyn. visits at the AMA cutoff, compared with below it, the percentage of individuals with any maternal-fetal medicine visit increased by 4.27 percentage points (P < .001) at the cutoff. Additionally, while there was a “modest” increase in total ultrasounds (P = .006), there was a significant increase in detailed ultrasounds (P < .001) at the cutoff, and a “substantial” increase in antepartum surveillance (P < .001), the authors reported.
The AMA designation was associated with a 0.39 percentage-point decline in perinatal mortality (P = .04), “however, there were no significant changes in the proportion of individuals with severe maternal morbidity or with preterm birth or low birth weight at age 35 years,” they wrote.
In the subgroup analysis of low-risk pregnancies, “prenatal care services increased substantially at the 35-year cutoff, and in all cases, the increases at age 35 years for this group were larger than for the full sample,” they noted, adding that there was also a “substantially larger” decline in perinatal mortality at the AMA cutoff (P = .002), compared with the full sample.
The authors noted the need for more rigorous evidence on the value and effect of prenatal care guidelines on pregnancy outcomes. “Although pregnancy-related risks increase with maternal age, there is no known abrupt biological increase in underlying risk precisely at age 35 years,” they wrote, adding that “much of the content of prenatal care guidelines has persisted for decades without strong causal evidence to demonstrate its value.”
Their words echo those of Alex F. Peahl, MD, an ob.gyn. and assistant professor at the Institute for Healthcare Policy and Innovation, at the University of Michigan, in Ann Arbor, MI. In a recent review, Dr. Peahl and her colleague Joel D. Howell, MD, PhD, from the same university (Am J Obstet Gynecol. 2021 Apr;224[4]:339-47), note that the COVID-19 pandemic forced a much-needed rethink of prenatal care and its delivery. A look through the history of prenatal care shows “we have treated visit frequency and modality as fixed boxes, into which we must fit an ever-changing set of care recommendations,” they wrote. “We do not have data to support a specific prenatal visit schedule, recommended number of telemedicine visits, or specifications of additional services, and we never have. However, one thing is clear: we are long overdue for new prenatal care delivery guidelines in the United States.”
But when reached for comment on the new study Dr. Peahl cautioned that its conclusions are “limited and warrant future investigation. … While increased prenatal services may explain the improvement in outcomes, several other explanations should be considered,” she told this publication. “Perhaps, maternity care professional behavior differs for patients who are over the age of 35, resulting in increased caution in interpreting test results and symptoms; perhaps patients are more routinely induced at 39 weeks, limiting stillbirth rate; or perhaps patients are more hypervigilant when given the diagnosis of AMA.”
Priya Rajan, MD, agreed that while the paper showed an association between intensified antenatal interventions and decreased perinatal mortality, it did not show a causal relationship. “The study did not include information on other important factors that are also associated with perinatal risk,” noted Dr. Rajan, who is an associate professor in the department of ob.gyn. at Northwestern University in Chicago. Yet, she acknowledged that the findings “support what many clinicians know, which is that age 35 isn’t some tipping point; rather, obstetric risk is influenced by a range of factors, of which age may be one. This study, particularly when considered in the context of other studies and articles we have seen recently, confirms the need for us to rethink how we care for people during pregnancy and post partum. This includes delving further into understanding what aspects of the prenatal care that we provide have the biggest impact for both maternal and perinatal adverse outcomes.”
The study was supported by grant DGE1745303 from the National Science Foundation Graduate Research Fellowship Program. Dr. Geiger reported being a PhD student during the conduction of the study, but had no other disclosures. Dr. Peahl will soon be a consultant for Maven Clinic. Dr. Rajan had no relevant disclosures.
JAMA HEALTH FORUM
TikTok trends: Do or diet, plan ‘c,' garlic where?
The year is rapidly approaching an end, and with it, we can perhaps look forward to better and brighter days in 2022. With daylight savings, seasonal depression, and cold and flu season making a comeback as temperatures across the Northern Hemisphere drop,
The good: doctor reveals the truth about dieting
Chisom Ikeji, MD, is a critical care clinical fellow at the University of Pittsburgh Medical Center and on TikTok under the username @drchizmd. In a TikTok with almost 200,000 views and over 18,000 likes, Dr. Ikeji explains to all New Year’s resolution-makers that dieting isn’t all it’s cracked up to be. “Dieting leads to perpetually losing weight and gaining weight on a cycle,” she says, “so that your body never really settles at its set point weight.”
Celebrities and your friends who drink lemon water in the morning may tout all sorts of fad diets and some of them might even work. But Dr. Ikeji explains that diets with gimmicks don’t have lasting power and create cycles of losing and gaining weight. Additionally, associating “points” with foods, or separating them into “good” or “bad” categories, encourages habits that can lead to disordered eating.
The best way to keep weight off is to make actual lifestyle changes that stick. In contrast, going back to dieting every year (the rapid cycle of losing and gaining weight is called “yo-yo” dieting) can have a bad impact on your health, including increased risk of heart disease and metabolism issues.
“The best thing you can do for your body, and to help you lose weight, is to stop dieting,” Dr. Ikeji says. “Incorporate whole foods into your diet and make sure you move your body. If you don’t, you’ll be chasing that diet into your 80s and feeling guilty over a piece of cake forever. That’s no way to live life.”
The bad: vitamin C contraceptive
In this TikTok, user @itsdiosa reveals her contraception hack for anyone with a uterus who may be having unprotected sex. She claims that for those who forget to take the Plan B pill, vitamin C is a worthwhile substitute in preventing unwanted pregnancy. She recommends taking four or five vitamin C tablets a day for a few days for the return of a normal period.
Not surprisingly, Vitamin C isn’t safe or reliable and doesn’t have studies to back up @itsdiosa’s claim. If anything, all you’ll get from taking too much vitamin C is diarrhea and a stomachache.
Karan Rajan, MBBS, from Imperial College London and the University of Sunderland in the United Kingdom, responded to the TikTok to confirm that this claim isn’t backed up by science.
“Vitamin C doesn’t start or stop a period. Period,” he commented on the video.
The ugly: garlic sinus decongestant
Now this one went viral one went viral with over 5.2 million likes. In this TikTok, @hwannah5 and her boyfriend try out a trend that involves putting a clove of peeled garlic in each nostril in order to clear up congestion. The bubbles of ooey gooey snot coming out of her boyfriend’s nose certainly make it seem like it’s working, but what’s really going on?
This is hardly new; people have been putting strange things in nasal rinses for some time now and garlic is a tried-and-true favorite. Garlic does have some medically valid uses. These studies have shown that garlic taken orally may improve insulin in people with diabetes, slightly lower cholesterol, and reduce blood pressure in people with hypertension. When it comes to home remedies, people have historically used garlic as an antiseptic, antibacterial, and antifungal agent, though these claims are not widely supported by research. But taking a garlic supplement and sticking raw garlic up your nose are two very different things.
New York-based board-certified dermatologist Whitney Bowe, MD, weighed in on the viral trend.
In her own reaction video, she explained: “Guys, this is actually not safe. What’s happening is the garlic is actually triggering something called contact dermatitis and the mucosa is trying to protect itself by secreting tons of mucus. It’s creating swelling.”
For those tempted by this smelly “remedy,” a few drops of essential oil in a steamy shower is a much more pleasant (and significantly less gross) way to treat congestion.
A version of this article first appeared on Medscape.com.
The year is rapidly approaching an end, and with it, we can perhaps look forward to better and brighter days in 2022. With daylight savings, seasonal depression, and cold and flu season making a comeback as temperatures across the Northern Hemisphere drop,
The good: doctor reveals the truth about dieting
Chisom Ikeji, MD, is a critical care clinical fellow at the University of Pittsburgh Medical Center and on TikTok under the username @drchizmd. In a TikTok with almost 200,000 views and over 18,000 likes, Dr. Ikeji explains to all New Year’s resolution-makers that dieting isn’t all it’s cracked up to be. “Dieting leads to perpetually losing weight and gaining weight on a cycle,” she says, “so that your body never really settles at its set point weight.”
Celebrities and your friends who drink lemon water in the morning may tout all sorts of fad diets and some of them might even work. But Dr. Ikeji explains that diets with gimmicks don’t have lasting power and create cycles of losing and gaining weight. Additionally, associating “points” with foods, or separating them into “good” or “bad” categories, encourages habits that can lead to disordered eating.
The best way to keep weight off is to make actual lifestyle changes that stick. In contrast, going back to dieting every year (the rapid cycle of losing and gaining weight is called “yo-yo” dieting) can have a bad impact on your health, including increased risk of heart disease and metabolism issues.
“The best thing you can do for your body, and to help you lose weight, is to stop dieting,” Dr. Ikeji says. “Incorporate whole foods into your diet and make sure you move your body. If you don’t, you’ll be chasing that diet into your 80s and feeling guilty over a piece of cake forever. That’s no way to live life.”
The bad: vitamin C contraceptive
In this TikTok, user @itsdiosa reveals her contraception hack for anyone with a uterus who may be having unprotected sex. She claims that for those who forget to take the Plan B pill, vitamin C is a worthwhile substitute in preventing unwanted pregnancy. She recommends taking four or five vitamin C tablets a day for a few days for the return of a normal period.
Not surprisingly, Vitamin C isn’t safe or reliable and doesn’t have studies to back up @itsdiosa’s claim. If anything, all you’ll get from taking too much vitamin C is diarrhea and a stomachache.
Karan Rajan, MBBS, from Imperial College London and the University of Sunderland in the United Kingdom, responded to the TikTok to confirm that this claim isn’t backed up by science.
“Vitamin C doesn’t start or stop a period. Period,” he commented on the video.
The ugly: garlic sinus decongestant
Now this one went viral one went viral with over 5.2 million likes. In this TikTok, @hwannah5 and her boyfriend try out a trend that involves putting a clove of peeled garlic in each nostril in order to clear up congestion. The bubbles of ooey gooey snot coming out of her boyfriend’s nose certainly make it seem like it’s working, but what’s really going on?
This is hardly new; people have been putting strange things in nasal rinses for some time now and garlic is a tried-and-true favorite. Garlic does have some medically valid uses. These studies have shown that garlic taken orally may improve insulin in people with diabetes, slightly lower cholesterol, and reduce blood pressure in people with hypertension. When it comes to home remedies, people have historically used garlic as an antiseptic, antibacterial, and antifungal agent, though these claims are not widely supported by research. But taking a garlic supplement and sticking raw garlic up your nose are two very different things.
New York-based board-certified dermatologist Whitney Bowe, MD, weighed in on the viral trend.
In her own reaction video, she explained: “Guys, this is actually not safe. What’s happening is the garlic is actually triggering something called contact dermatitis and the mucosa is trying to protect itself by secreting tons of mucus. It’s creating swelling.”
For those tempted by this smelly “remedy,” a few drops of essential oil in a steamy shower is a much more pleasant (and significantly less gross) way to treat congestion.
A version of this article first appeared on Medscape.com.
The year is rapidly approaching an end, and with it, we can perhaps look forward to better and brighter days in 2022. With daylight savings, seasonal depression, and cold and flu season making a comeback as temperatures across the Northern Hemisphere drop,
The good: doctor reveals the truth about dieting
Chisom Ikeji, MD, is a critical care clinical fellow at the University of Pittsburgh Medical Center and on TikTok under the username @drchizmd. In a TikTok with almost 200,000 views and over 18,000 likes, Dr. Ikeji explains to all New Year’s resolution-makers that dieting isn’t all it’s cracked up to be. “Dieting leads to perpetually losing weight and gaining weight on a cycle,” she says, “so that your body never really settles at its set point weight.”
Celebrities and your friends who drink lemon water in the morning may tout all sorts of fad diets and some of them might even work. But Dr. Ikeji explains that diets with gimmicks don’t have lasting power and create cycles of losing and gaining weight. Additionally, associating “points” with foods, or separating them into “good” or “bad” categories, encourages habits that can lead to disordered eating.
The best way to keep weight off is to make actual lifestyle changes that stick. In contrast, going back to dieting every year (the rapid cycle of losing and gaining weight is called “yo-yo” dieting) can have a bad impact on your health, including increased risk of heart disease and metabolism issues.
“The best thing you can do for your body, and to help you lose weight, is to stop dieting,” Dr. Ikeji says. “Incorporate whole foods into your diet and make sure you move your body. If you don’t, you’ll be chasing that diet into your 80s and feeling guilty over a piece of cake forever. That’s no way to live life.”
The bad: vitamin C contraceptive
In this TikTok, user @itsdiosa reveals her contraception hack for anyone with a uterus who may be having unprotected sex. She claims that for those who forget to take the Plan B pill, vitamin C is a worthwhile substitute in preventing unwanted pregnancy. She recommends taking four or five vitamin C tablets a day for a few days for the return of a normal period.
Not surprisingly, Vitamin C isn’t safe or reliable and doesn’t have studies to back up @itsdiosa’s claim. If anything, all you’ll get from taking too much vitamin C is diarrhea and a stomachache.
Karan Rajan, MBBS, from Imperial College London and the University of Sunderland in the United Kingdom, responded to the TikTok to confirm that this claim isn’t backed up by science.
“Vitamin C doesn’t start or stop a period. Period,” he commented on the video.
The ugly: garlic sinus decongestant
Now this one went viral one went viral with over 5.2 million likes. In this TikTok, @hwannah5 and her boyfriend try out a trend that involves putting a clove of peeled garlic in each nostril in order to clear up congestion. The bubbles of ooey gooey snot coming out of her boyfriend’s nose certainly make it seem like it’s working, but what’s really going on?
This is hardly new; people have been putting strange things in nasal rinses for some time now and garlic is a tried-and-true favorite. Garlic does have some medically valid uses. These studies have shown that garlic taken orally may improve insulin in people with diabetes, slightly lower cholesterol, and reduce blood pressure in people with hypertension. When it comes to home remedies, people have historically used garlic as an antiseptic, antibacterial, and antifungal agent, though these claims are not widely supported by research. But taking a garlic supplement and sticking raw garlic up your nose are two very different things.
New York-based board-certified dermatologist Whitney Bowe, MD, weighed in on the viral trend.
In her own reaction video, she explained: “Guys, this is actually not safe. What’s happening is the garlic is actually triggering something called contact dermatitis and the mucosa is trying to protect itself by secreting tons of mucus. It’s creating swelling.”
For those tempted by this smelly “remedy,” a few drops of essential oil in a steamy shower is a much more pleasant (and significantly less gross) way to treat congestion.
A version of this article first appeared on Medscape.com.
New HIV PrEP guidelines call for clinicians to talk to patients about HIV prevention meds
Starting Dec. 8, the Centers for Disease Control and Prevention recommends all clinicians talk to their sexually active adolescent and adult patients about HIV pre-exposure prophylaxis (PrEP) at least once and prescribe the prevention pills to anyone who asks for them, whether or not you understand their need for it.
“PrEP is a part of good primary care,” Demetre Daskalakis, MD, CDC’s director of the division of HIV/AIDS prevention, said in an interview. “Listening to people and what they need, as opposed to assessing what you think they need, is a seismic shift in how PrEP should be offered.”
The expanded recommendation comes as part of the 2021 update to the U.S. Public Health Service’s PrEP prescribing guidelines. It’s the third iteration since the Food and Drug Administration approved the first HIV prevention pill in 2012, and the first to include guidance on how to prescribe and monitor an injectable version of PrEP, which the FDA may approve as early as December 2021.
There are currently two pills, Truvada (emtricitabine/tenofovir disoproxil fumarate, Gilead Sciences and generic) and Descovy (emtricitabine/tenofovir alafenamide, Gilead Sciences). The pills have been found to be up to 99% effective in preventing HIV acquisition. The new injectable cabotegravir appears to be even more effective.
The broadened guidance is part of an effort from the country’s top health officials to expand PrEP prescribing from infectious disease specialists and sexual health clinics to health care professionals, including gynecologists, internal medicine physicians, and family practice clinicians. It appears to be necessary. In 2020, just 25% of the 1.2 million Americans who could benefit from PrEP were taking it, according to CDC data.
But those rates belie stark disparities in PrEP use by race and gender. The vast majority of those using PrEP are White Americans and men. About 66% of White Americans who could benefit from PrEP used it in 2020, and more than a quarter of the men who could benefit used it. By contrast, just 16% of Latinx people who could benefit had a prescription. And fewer than 1 in 10 Black Americans, who make up nearly half of those with indications for PrEP, had a prescription. The same was true for the women who could benefit.
Researchers and data from early PrEP demonstration projects have documented that clinicians are less likely to refer or prescribe the HIV prevention pills to Black people, especially the Black cisgender and transgender women and same-gender-loving men who bear the disproportionate burden of new cases in the United States, as well as fail to prescribe the medication to people who inject drugs.
Normalizing PrEP in primary care
When Courtney Sherman, DNP, APRN, first heard about PrEP in the early 2010s, she joked that her reaction was: “You’re ridiculous. You’re making that up. That’s not real.”
Ms. Sherman is now launching a tele-PrEP program from CAN Community Health, a nonprofit network of community health centers in southern Florida. The tele-PrEP program is meant to serve people in Florida and beyond, to increase access to the pill in areas with few health care professionals, or clinicians unwilling to prescribe it.
“When I go other places, I can’t do what I do for a living without getting some sort of bizarre comment or look,” she said. But the looks don’t just come from family, friends, or her children’s teachers. They come from colleagues, too. “What I’ve learned is that anybody – anybody – can be impacted [by HIV] and the illusion that ‘those people who live over there do things that me and my kind don’t do’ is just garbage.”
That’s the PrEP stigma that the universal PrEP counseling in the guidelines is meant to override, said Dr. Daskalakis. Going forward, he said that informing people about PrEP should be treated as normally as counseling people about smoking.
“You can change the blank: You talk to all adolescents and adults about not smoking,” he said. “This is: ‘Tell adolescents and adults about ways you can prevent HIV, and PrEP is one of them.’ ”
The guidelines also simplify for monitoring lab levels for the current daily pills, checking creatinine clearance levels twice a year in people older than age 50 and once a year in those younger than 50 taking the oral pills. Dr. Daskalakis said that should ease the burden of monitoring PrEP patients for health care professionals with busy caseloads.
It’s a move that drew praise from Shawnika Hull, PhD, assistant professor of health communications at Rutgers University, New Brunswick, N.J.. Dr. Hull’s recent data showed that clinicians who espoused more biased racial views were also less likely to prescribe PrEP to Black women who asked for it.
“Public health practitioners and scientists have been advocating for this as a strategy, as one way to address several ongoing barriers to PrEP specifically but also equity in PrEP,” said Dr. Hull. “This sort of universal provision of information is really an important strategy to try to undo some of the deeply intertwined barriers to uptake.”
‘Don’t grill them’
The updated guidelines keep the number and proportion of Americans who could benefit from PrEP the same: 1.2 million Americans, with nearly half of those Black. And the reasons people would qualify for PrEP remain the same: inconsistent condom use, sharing injection drug equipment, and a STI diagnosis in the last 6 months. There are also 57 jurisdictions, including seven rural states, where dating and having sex carries an increased risk of acquiring HIV because of high rates of untreated HIV in the community.
That’s why the other big change in the update is guidance to prescribe PrEP to whoever asks for it, whether the patient divulges their risk or not. Or as Dr. Daskalakis puts it: “If someone asks for PrEP, don’t grill them.”
There are lots of reasons that someone might ask for PrEP without divulging their risk behaviors, said Dr. Daskalakis, who was an infectious disease doctor in New York back in 2012 (and a member of the FDA committee) when the first pill for PrEP was approved. He said he’s seen this particularly with women who ask about it. Asking for PrEP ends up being an “ice breaker” to discussing the woman’s sexual and injection drug use history, which can then improve the kinds of tests and vaccinations clinicians suggest for her.
“So many women will open the door and say, ‘I want to do this,’ and not necessarily want to go into the details,” he said. “Now, will they go into the details later? Absolutely. That’s how you create trust and connection.”
A mandate and a guideline
Leisha McKinley-Beach, MPH, a member of the U.S. Women and PrEP Working Group, has been urging greater funding and mandates to expand PrEP to women since the first pill was approved. And still, Ms. McKinley-Beach said she recently met a woman who worked for a community group scheduling PrEP appointments for gay men. But the woman didn’t know that she, too, could take it.
The American Academy of Family Physicians recommends health care professionals offer PrEP to those who can benefit. The American College of Obstetricians and Gynecologists have a 2014 committee opinion stating that PrEP “may be a useful tool for women at highest risk of HIV acquisition.”
But the ACOG opinion is not a recommendation, stating that it “should not be construed as dictating an exclusive course of treatment or procedure to be followed.” Ms. McKinley-Beach said she hopes that the new CDC guidelines will prompt ACOG and other professional organizations to issue statements to include PrEP education in all health assessments. A spokesperson for ACOG said that the organization had not seen the new CDC guidelines and had no statement on them, but pointed out that the 2014 committee opinion is one of the “highest level of documents we produce.
“We have failed for nearly a decade to raise awareness that PrEP is also a prevention strategy for women,” Ms. McKinley-Beach said in an interview. “In many ways, we’re still back in 2012 as it relates to women.”
Dr. Hull reported having done previous research funded by Gilead Sciences and having received consulting fees from Gilead Sciences in 2018. Ms. McKinley-Beach reported receiving honoraria from ViiV Healthcare. Ms. Sherman and Dr. Daskalakis disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Starting Dec. 8, the Centers for Disease Control and Prevention recommends all clinicians talk to their sexually active adolescent and adult patients about HIV pre-exposure prophylaxis (PrEP) at least once and prescribe the prevention pills to anyone who asks for them, whether or not you understand their need for it.
“PrEP is a part of good primary care,” Demetre Daskalakis, MD, CDC’s director of the division of HIV/AIDS prevention, said in an interview. “Listening to people and what they need, as opposed to assessing what you think they need, is a seismic shift in how PrEP should be offered.”
The expanded recommendation comes as part of the 2021 update to the U.S. Public Health Service’s PrEP prescribing guidelines. It’s the third iteration since the Food and Drug Administration approved the first HIV prevention pill in 2012, and the first to include guidance on how to prescribe and monitor an injectable version of PrEP, which the FDA may approve as early as December 2021.
There are currently two pills, Truvada (emtricitabine/tenofovir disoproxil fumarate, Gilead Sciences and generic) and Descovy (emtricitabine/tenofovir alafenamide, Gilead Sciences). The pills have been found to be up to 99% effective in preventing HIV acquisition. The new injectable cabotegravir appears to be even more effective.
The broadened guidance is part of an effort from the country’s top health officials to expand PrEP prescribing from infectious disease specialists and sexual health clinics to health care professionals, including gynecologists, internal medicine physicians, and family practice clinicians. It appears to be necessary. In 2020, just 25% of the 1.2 million Americans who could benefit from PrEP were taking it, according to CDC data.
But those rates belie stark disparities in PrEP use by race and gender. The vast majority of those using PrEP are White Americans and men. About 66% of White Americans who could benefit from PrEP used it in 2020, and more than a quarter of the men who could benefit used it. By contrast, just 16% of Latinx people who could benefit had a prescription. And fewer than 1 in 10 Black Americans, who make up nearly half of those with indications for PrEP, had a prescription. The same was true for the women who could benefit.
Researchers and data from early PrEP demonstration projects have documented that clinicians are less likely to refer or prescribe the HIV prevention pills to Black people, especially the Black cisgender and transgender women and same-gender-loving men who bear the disproportionate burden of new cases in the United States, as well as fail to prescribe the medication to people who inject drugs.
Normalizing PrEP in primary care
When Courtney Sherman, DNP, APRN, first heard about PrEP in the early 2010s, she joked that her reaction was: “You’re ridiculous. You’re making that up. That’s not real.”
Ms. Sherman is now launching a tele-PrEP program from CAN Community Health, a nonprofit network of community health centers in southern Florida. The tele-PrEP program is meant to serve people in Florida and beyond, to increase access to the pill in areas with few health care professionals, or clinicians unwilling to prescribe it.
“When I go other places, I can’t do what I do for a living without getting some sort of bizarre comment or look,” she said. But the looks don’t just come from family, friends, or her children’s teachers. They come from colleagues, too. “What I’ve learned is that anybody – anybody – can be impacted [by HIV] and the illusion that ‘those people who live over there do things that me and my kind don’t do’ is just garbage.”
That’s the PrEP stigma that the universal PrEP counseling in the guidelines is meant to override, said Dr. Daskalakis. Going forward, he said that informing people about PrEP should be treated as normally as counseling people about smoking.
“You can change the blank: You talk to all adolescents and adults about not smoking,” he said. “This is: ‘Tell adolescents and adults about ways you can prevent HIV, and PrEP is one of them.’ ”
The guidelines also simplify for monitoring lab levels for the current daily pills, checking creatinine clearance levels twice a year in people older than age 50 and once a year in those younger than 50 taking the oral pills. Dr. Daskalakis said that should ease the burden of monitoring PrEP patients for health care professionals with busy caseloads.
It’s a move that drew praise from Shawnika Hull, PhD, assistant professor of health communications at Rutgers University, New Brunswick, N.J.. Dr. Hull’s recent data showed that clinicians who espoused more biased racial views were also less likely to prescribe PrEP to Black women who asked for it.
“Public health practitioners and scientists have been advocating for this as a strategy, as one way to address several ongoing barriers to PrEP specifically but also equity in PrEP,” said Dr. Hull. “This sort of universal provision of information is really an important strategy to try to undo some of the deeply intertwined barriers to uptake.”
‘Don’t grill them’
The updated guidelines keep the number and proportion of Americans who could benefit from PrEP the same: 1.2 million Americans, with nearly half of those Black. And the reasons people would qualify for PrEP remain the same: inconsistent condom use, sharing injection drug equipment, and a STI diagnosis in the last 6 months. There are also 57 jurisdictions, including seven rural states, where dating and having sex carries an increased risk of acquiring HIV because of high rates of untreated HIV in the community.
That’s why the other big change in the update is guidance to prescribe PrEP to whoever asks for it, whether the patient divulges their risk or not. Or as Dr. Daskalakis puts it: “If someone asks for PrEP, don’t grill them.”
There are lots of reasons that someone might ask for PrEP without divulging their risk behaviors, said Dr. Daskalakis, who was an infectious disease doctor in New York back in 2012 (and a member of the FDA committee) when the first pill for PrEP was approved. He said he’s seen this particularly with women who ask about it. Asking for PrEP ends up being an “ice breaker” to discussing the woman’s sexual and injection drug use history, which can then improve the kinds of tests and vaccinations clinicians suggest for her.
“So many women will open the door and say, ‘I want to do this,’ and not necessarily want to go into the details,” he said. “Now, will they go into the details later? Absolutely. That’s how you create trust and connection.”
A mandate and a guideline
Leisha McKinley-Beach, MPH, a member of the U.S. Women and PrEP Working Group, has been urging greater funding and mandates to expand PrEP to women since the first pill was approved. And still, Ms. McKinley-Beach said she recently met a woman who worked for a community group scheduling PrEP appointments for gay men. But the woman didn’t know that she, too, could take it.
The American Academy of Family Physicians recommends health care professionals offer PrEP to those who can benefit. The American College of Obstetricians and Gynecologists have a 2014 committee opinion stating that PrEP “may be a useful tool for women at highest risk of HIV acquisition.”
But the ACOG opinion is not a recommendation, stating that it “should not be construed as dictating an exclusive course of treatment or procedure to be followed.” Ms. McKinley-Beach said she hopes that the new CDC guidelines will prompt ACOG and other professional organizations to issue statements to include PrEP education in all health assessments. A spokesperson for ACOG said that the organization had not seen the new CDC guidelines and had no statement on them, but pointed out that the 2014 committee opinion is one of the “highest level of documents we produce.
“We have failed for nearly a decade to raise awareness that PrEP is also a prevention strategy for women,” Ms. McKinley-Beach said in an interview. “In many ways, we’re still back in 2012 as it relates to women.”
Dr. Hull reported having done previous research funded by Gilead Sciences and having received consulting fees from Gilead Sciences in 2018. Ms. McKinley-Beach reported receiving honoraria from ViiV Healthcare. Ms. Sherman and Dr. Daskalakis disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Starting Dec. 8, the Centers for Disease Control and Prevention recommends all clinicians talk to their sexually active adolescent and adult patients about HIV pre-exposure prophylaxis (PrEP) at least once and prescribe the prevention pills to anyone who asks for them, whether or not you understand their need for it.
“PrEP is a part of good primary care,” Demetre Daskalakis, MD, CDC’s director of the division of HIV/AIDS prevention, said in an interview. “Listening to people and what they need, as opposed to assessing what you think they need, is a seismic shift in how PrEP should be offered.”
The expanded recommendation comes as part of the 2021 update to the U.S. Public Health Service’s PrEP prescribing guidelines. It’s the third iteration since the Food and Drug Administration approved the first HIV prevention pill in 2012, and the first to include guidance on how to prescribe and monitor an injectable version of PrEP, which the FDA may approve as early as December 2021.
There are currently two pills, Truvada (emtricitabine/tenofovir disoproxil fumarate, Gilead Sciences and generic) and Descovy (emtricitabine/tenofovir alafenamide, Gilead Sciences). The pills have been found to be up to 99% effective in preventing HIV acquisition. The new injectable cabotegravir appears to be even more effective.
The broadened guidance is part of an effort from the country’s top health officials to expand PrEP prescribing from infectious disease specialists and sexual health clinics to health care professionals, including gynecologists, internal medicine physicians, and family practice clinicians. It appears to be necessary. In 2020, just 25% of the 1.2 million Americans who could benefit from PrEP were taking it, according to CDC data.
But those rates belie stark disparities in PrEP use by race and gender. The vast majority of those using PrEP are White Americans and men. About 66% of White Americans who could benefit from PrEP used it in 2020, and more than a quarter of the men who could benefit used it. By contrast, just 16% of Latinx people who could benefit had a prescription. And fewer than 1 in 10 Black Americans, who make up nearly half of those with indications for PrEP, had a prescription. The same was true for the women who could benefit.
Researchers and data from early PrEP demonstration projects have documented that clinicians are less likely to refer or prescribe the HIV prevention pills to Black people, especially the Black cisgender and transgender women and same-gender-loving men who bear the disproportionate burden of new cases in the United States, as well as fail to prescribe the medication to people who inject drugs.
Normalizing PrEP in primary care
When Courtney Sherman, DNP, APRN, first heard about PrEP in the early 2010s, she joked that her reaction was: “You’re ridiculous. You’re making that up. That’s not real.”
Ms. Sherman is now launching a tele-PrEP program from CAN Community Health, a nonprofit network of community health centers in southern Florida. The tele-PrEP program is meant to serve people in Florida and beyond, to increase access to the pill in areas with few health care professionals, or clinicians unwilling to prescribe it.
“When I go other places, I can’t do what I do for a living without getting some sort of bizarre comment or look,” she said. But the looks don’t just come from family, friends, or her children’s teachers. They come from colleagues, too. “What I’ve learned is that anybody – anybody – can be impacted [by HIV] and the illusion that ‘those people who live over there do things that me and my kind don’t do’ is just garbage.”
That’s the PrEP stigma that the universal PrEP counseling in the guidelines is meant to override, said Dr. Daskalakis. Going forward, he said that informing people about PrEP should be treated as normally as counseling people about smoking.
“You can change the blank: You talk to all adolescents and adults about not smoking,” he said. “This is: ‘Tell adolescents and adults about ways you can prevent HIV, and PrEP is one of them.’ ”
The guidelines also simplify for monitoring lab levels for the current daily pills, checking creatinine clearance levels twice a year in people older than age 50 and once a year in those younger than 50 taking the oral pills. Dr. Daskalakis said that should ease the burden of monitoring PrEP patients for health care professionals with busy caseloads.
It’s a move that drew praise from Shawnika Hull, PhD, assistant professor of health communications at Rutgers University, New Brunswick, N.J.. Dr. Hull’s recent data showed that clinicians who espoused more biased racial views were also less likely to prescribe PrEP to Black women who asked for it.
“Public health practitioners and scientists have been advocating for this as a strategy, as one way to address several ongoing barriers to PrEP specifically but also equity in PrEP,” said Dr. Hull. “This sort of universal provision of information is really an important strategy to try to undo some of the deeply intertwined barriers to uptake.”
‘Don’t grill them’
The updated guidelines keep the number and proportion of Americans who could benefit from PrEP the same: 1.2 million Americans, with nearly half of those Black. And the reasons people would qualify for PrEP remain the same: inconsistent condom use, sharing injection drug equipment, and a STI diagnosis in the last 6 months. There are also 57 jurisdictions, including seven rural states, where dating and having sex carries an increased risk of acquiring HIV because of high rates of untreated HIV in the community.
That’s why the other big change in the update is guidance to prescribe PrEP to whoever asks for it, whether the patient divulges their risk or not. Or as Dr. Daskalakis puts it: “If someone asks for PrEP, don’t grill them.”
There are lots of reasons that someone might ask for PrEP without divulging their risk behaviors, said Dr. Daskalakis, who was an infectious disease doctor in New York back in 2012 (and a member of the FDA committee) when the first pill for PrEP was approved. He said he’s seen this particularly with women who ask about it. Asking for PrEP ends up being an “ice breaker” to discussing the woman’s sexual and injection drug use history, which can then improve the kinds of tests and vaccinations clinicians suggest for her.
“So many women will open the door and say, ‘I want to do this,’ and not necessarily want to go into the details,” he said. “Now, will they go into the details later? Absolutely. That’s how you create trust and connection.”
A mandate and a guideline
Leisha McKinley-Beach, MPH, a member of the U.S. Women and PrEP Working Group, has been urging greater funding and mandates to expand PrEP to women since the first pill was approved. And still, Ms. McKinley-Beach said she recently met a woman who worked for a community group scheduling PrEP appointments for gay men. But the woman didn’t know that she, too, could take it.
The American Academy of Family Physicians recommends health care professionals offer PrEP to those who can benefit. The American College of Obstetricians and Gynecologists have a 2014 committee opinion stating that PrEP “may be a useful tool for women at highest risk of HIV acquisition.”
But the ACOG opinion is not a recommendation, stating that it “should not be construed as dictating an exclusive course of treatment or procedure to be followed.” Ms. McKinley-Beach said she hopes that the new CDC guidelines will prompt ACOG and other professional organizations to issue statements to include PrEP education in all health assessments. A spokesperson for ACOG said that the organization had not seen the new CDC guidelines and had no statement on them, but pointed out that the 2014 committee opinion is one of the “highest level of documents we produce.
“We have failed for nearly a decade to raise awareness that PrEP is also a prevention strategy for women,” Ms. McKinley-Beach said in an interview. “In many ways, we’re still back in 2012 as it relates to women.”
Dr. Hull reported having done previous research funded by Gilead Sciences and having received consulting fees from Gilead Sciences in 2018. Ms. McKinley-Beach reported receiving honoraria from ViiV Healthcare. Ms. Sherman and Dr. Daskalakis disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.