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CDC panel lists reasons to get second COVID booster
The Centers for Disease Control and Prevention is considering what to tell the public about second booster shots with mRNA vaccinations for COVID-19.
The U.S. Food and Drug Administration in March authorized a second booster dose of either the Pfizer-BioNTech or the Moderna COVID-19 vaccines for people aged 50 and older and certain immunocompromised adults, even though many top infectious disease experts questioned the need before the agency’s decision.
In a meeting April 20, the CDC asked its Advisory Committee on Immunization Practices to discuss second booster shots, but did not ask the group of experts to vote on formal recommendations.
Instead,
ACIP member Beth Bell, MD, MPH, of the University of Washington, Seattle, said she’s concerned about the potential for “booster fatigue.”
“A vaccination program that’s going to require boosting large proportions of the population every 4-6 months is really not sustainable and probably not something that most people want to participate in,” she said.
The benefit of additional COVID-19 shots for now appears to be smaller than what people get from the initial doses, Dr. Bell said.
Earlier in the meeting, CDC staff presented estimates about how well the COVID-19 vaccines work to prevent one case of hospitalization from the disease over 4 months among people aged 50 and older.
The major gain in preventing hospitalizations occurs with the first vaccination series and then wanes, the CDC said.
It appears that one hospitalization is prevented for every 135 people who get the first round of COVID-19 vaccinations. But it takes 674 people getting a first booster dose to prevent one hospitalization. A second booster prevents one hospitalization for every 1,205 people vaccinated.
Dr. Bell said she’s concerned about considering additional doses for “smaller and smaller return and creating an impression that we don’t have a very effective vaccination program,” even though the CDC’s data show a clear benefit.
Reasons to get a second booster
Elisha Hall, PhD, RD, of the CDC presented slides with some factors to help determine the urgency for a person to get a second booster:
- Having certain underlying medical conditions that increase the risk of severe COVID-19 illness.
- Being moderately or severely immunocompromised.
- Living with someone who is immunocompromised, at increased risk for severe disease, or who cannot be vaccinated because of age or contraindication.
- Being at increased risk of exposure to SARS-CoV-2, the virus that causes COVID-19, such as through occupational, institutional, or other activities (e.g., travel or large gatherings).
- Living or working in an area where there is a medium or high level of COVID-19 in the community.
In contrast, people might want to wait if they had been infected with SARS-CoV-2 within the past 3 months, Dr. Hall said in her presentation. Another reason for delay might be a concern that a booster dose may be more important later in the year.
The experts also addressed public confusion over boosters. For the Pfizer and Moderna mRNA vaccines, a second booster is a fourth dose, but for those who received the one-shot J&J vaccine, the second booster is a third dose.
Going forward, it may be easier to refer to subsequent doses as “annual boosters,” the CDC’s Sara Oliver, MD, MSPH, told the panel. It will be important to keep language about subsequent vaccinations clear and easy for the public to follow, she said.
Dr. Oliver also said there’s already been a drop-off in the acceptance of second rounds of COVID-19 vaccinations. CDC data show that 77% of people in the United States have had at least one dose of a COVID-19 vaccine, but only 66% of the population is fully vaccinated, and only 45% have had a first booster dose.
In her presentation, Dr. Oliver said the top priority in COVID-19 vaccination efforts remains initial vaccinations for people who haven’t gotten them.
Kids younger than 5
During the public comment session of the CDC meeting, several people called on the FDA to move quickly to expand authorization of COVID-19 vaccines to children aged 5 years and younger.
“We know that many parents and caregivers and health care providers are anxious to have COVID vaccines available” for young children, said Doran Fink, MD, PhD, a deputy director of the FDA’s vaccines division.
He said the agency is working to be ready to authorize the shots for young children while it awaits research results from the manufacturers.
A version of this article first appeared on WebMD.com.
The Centers for Disease Control and Prevention is considering what to tell the public about second booster shots with mRNA vaccinations for COVID-19.
The U.S. Food and Drug Administration in March authorized a second booster dose of either the Pfizer-BioNTech or the Moderna COVID-19 vaccines for people aged 50 and older and certain immunocompromised adults, even though many top infectious disease experts questioned the need before the agency’s decision.
In a meeting April 20, the CDC asked its Advisory Committee on Immunization Practices to discuss second booster shots, but did not ask the group of experts to vote on formal recommendations.
Instead,
ACIP member Beth Bell, MD, MPH, of the University of Washington, Seattle, said she’s concerned about the potential for “booster fatigue.”
“A vaccination program that’s going to require boosting large proportions of the population every 4-6 months is really not sustainable and probably not something that most people want to participate in,” she said.
The benefit of additional COVID-19 shots for now appears to be smaller than what people get from the initial doses, Dr. Bell said.
Earlier in the meeting, CDC staff presented estimates about how well the COVID-19 vaccines work to prevent one case of hospitalization from the disease over 4 months among people aged 50 and older.
The major gain in preventing hospitalizations occurs with the first vaccination series and then wanes, the CDC said.
It appears that one hospitalization is prevented for every 135 people who get the first round of COVID-19 vaccinations. But it takes 674 people getting a first booster dose to prevent one hospitalization. A second booster prevents one hospitalization for every 1,205 people vaccinated.
Dr. Bell said she’s concerned about considering additional doses for “smaller and smaller return and creating an impression that we don’t have a very effective vaccination program,” even though the CDC’s data show a clear benefit.
Reasons to get a second booster
Elisha Hall, PhD, RD, of the CDC presented slides with some factors to help determine the urgency for a person to get a second booster:
- Having certain underlying medical conditions that increase the risk of severe COVID-19 illness.
- Being moderately or severely immunocompromised.
- Living with someone who is immunocompromised, at increased risk for severe disease, or who cannot be vaccinated because of age or contraindication.
- Being at increased risk of exposure to SARS-CoV-2, the virus that causes COVID-19, such as through occupational, institutional, or other activities (e.g., travel or large gatherings).
- Living or working in an area where there is a medium or high level of COVID-19 in the community.
In contrast, people might want to wait if they had been infected with SARS-CoV-2 within the past 3 months, Dr. Hall said in her presentation. Another reason for delay might be a concern that a booster dose may be more important later in the year.
The experts also addressed public confusion over boosters. For the Pfizer and Moderna mRNA vaccines, a second booster is a fourth dose, but for those who received the one-shot J&J vaccine, the second booster is a third dose.
Going forward, it may be easier to refer to subsequent doses as “annual boosters,” the CDC’s Sara Oliver, MD, MSPH, told the panel. It will be important to keep language about subsequent vaccinations clear and easy for the public to follow, she said.
Dr. Oliver also said there’s already been a drop-off in the acceptance of second rounds of COVID-19 vaccinations. CDC data show that 77% of people in the United States have had at least one dose of a COVID-19 vaccine, but only 66% of the population is fully vaccinated, and only 45% have had a first booster dose.
In her presentation, Dr. Oliver said the top priority in COVID-19 vaccination efforts remains initial vaccinations for people who haven’t gotten them.
Kids younger than 5
During the public comment session of the CDC meeting, several people called on the FDA to move quickly to expand authorization of COVID-19 vaccines to children aged 5 years and younger.
“We know that many parents and caregivers and health care providers are anxious to have COVID vaccines available” for young children, said Doran Fink, MD, PhD, a deputy director of the FDA’s vaccines division.
He said the agency is working to be ready to authorize the shots for young children while it awaits research results from the manufacturers.
A version of this article first appeared on WebMD.com.
The Centers for Disease Control and Prevention is considering what to tell the public about second booster shots with mRNA vaccinations for COVID-19.
The U.S. Food and Drug Administration in March authorized a second booster dose of either the Pfizer-BioNTech or the Moderna COVID-19 vaccines for people aged 50 and older and certain immunocompromised adults, even though many top infectious disease experts questioned the need before the agency’s decision.
In a meeting April 20, the CDC asked its Advisory Committee on Immunization Practices to discuss second booster shots, but did not ask the group of experts to vote on formal recommendations.
Instead,
ACIP member Beth Bell, MD, MPH, of the University of Washington, Seattle, said she’s concerned about the potential for “booster fatigue.”
“A vaccination program that’s going to require boosting large proportions of the population every 4-6 months is really not sustainable and probably not something that most people want to participate in,” she said.
The benefit of additional COVID-19 shots for now appears to be smaller than what people get from the initial doses, Dr. Bell said.
Earlier in the meeting, CDC staff presented estimates about how well the COVID-19 vaccines work to prevent one case of hospitalization from the disease over 4 months among people aged 50 and older.
The major gain in preventing hospitalizations occurs with the first vaccination series and then wanes, the CDC said.
It appears that one hospitalization is prevented for every 135 people who get the first round of COVID-19 vaccinations. But it takes 674 people getting a first booster dose to prevent one hospitalization. A second booster prevents one hospitalization for every 1,205 people vaccinated.
Dr. Bell said she’s concerned about considering additional doses for “smaller and smaller return and creating an impression that we don’t have a very effective vaccination program,” even though the CDC’s data show a clear benefit.
Reasons to get a second booster
Elisha Hall, PhD, RD, of the CDC presented slides with some factors to help determine the urgency for a person to get a second booster:
- Having certain underlying medical conditions that increase the risk of severe COVID-19 illness.
- Being moderately or severely immunocompromised.
- Living with someone who is immunocompromised, at increased risk for severe disease, or who cannot be vaccinated because of age or contraindication.
- Being at increased risk of exposure to SARS-CoV-2, the virus that causes COVID-19, such as through occupational, institutional, or other activities (e.g., travel or large gatherings).
- Living or working in an area where there is a medium or high level of COVID-19 in the community.
In contrast, people might want to wait if they had been infected with SARS-CoV-2 within the past 3 months, Dr. Hall said in her presentation. Another reason for delay might be a concern that a booster dose may be more important later in the year.
The experts also addressed public confusion over boosters. For the Pfizer and Moderna mRNA vaccines, a second booster is a fourth dose, but for those who received the one-shot J&J vaccine, the second booster is a third dose.
Going forward, it may be easier to refer to subsequent doses as “annual boosters,” the CDC’s Sara Oliver, MD, MSPH, told the panel. It will be important to keep language about subsequent vaccinations clear and easy for the public to follow, she said.
Dr. Oliver also said there’s already been a drop-off in the acceptance of second rounds of COVID-19 vaccinations. CDC data show that 77% of people in the United States have had at least one dose of a COVID-19 vaccine, but only 66% of the population is fully vaccinated, and only 45% have had a first booster dose.
In her presentation, Dr. Oliver said the top priority in COVID-19 vaccination efforts remains initial vaccinations for people who haven’t gotten them.
Kids younger than 5
During the public comment session of the CDC meeting, several people called on the FDA to move quickly to expand authorization of COVID-19 vaccines to children aged 5 years and younger.
“We know that many parents and caregivers and health care providers are anxious to have COVID vaccines available” for young children, said Doran Fink, MD, PhD, a deputy director of the FDA’s vaccines division.
He said the agency is working to be ready to authorize the shots for young children while it awaits research results from the manufacturers.
A version of this article first appeared on WebMD.com.
RaDonda Vaught: Victim, felon, or both?
For 4 and a half years, I have followed the RaDonda Vaught medication error that led to the unfortunate death of a human being. I am not alone. Nurses across the country have followed the case with anxiety and fear, knowing a guilty verdict might have the potential to challenge basic tenets of care.
According to Kaiser Health News, nurses are “raging and quitting” following the announcement of a guilty verdict for two felonies: criminally negligent homicide and gross neglect of an impaired adult.
Thousands of nurses have claimed they could arrive in Nashville, Tenn., on May 13, the day Ms. Vaught is to be sentenced, to protest the conviction. Others have stated they believe justice is being conducted, as their sympathies lie with the victim, Charlene Murphey, who died 12 hours after being unable to draw breath, paralyzed from the inadvertent dose of vecuronium given intravenously by her nurse.
How should we feel as clinicians? according to sentencing guidelines?
My belief is that it is understandable to feel passionately about this case, including what it could mean to an era of “just culture” that nursing organizations have promoted. The concept of just culture looks at medication/nursing errors as opportunities for growth to avoid future errors, not as scenarios for punitive action. With the guilty verdict in Ms. Vaught’s case, nurses (and facilities) fear that nurses will avoid coming forward after mistakes, leading to cover-ups and a culture perspective.
Will nurses be hesitant to report errors (especially significant errors) that lead to patient harm? Will we fear retribution and reprisal for being truthful?
I believe that Ms. Vaught’s criminal case has changed little in the political landscape of caregiving. Before you let loose with a loud expletive (or two), hear me out.
When a patient dies from unintentional harm, someone must be held accountable. Society needs a scapegoat, and unfortunately, excrement slides downhill to the lowest common denominator, which may be the nurse. Initially, Ms. Vaught was contacted by her state licensing board (Tennessee) and informed there would be no professional repercussions for her mistake. That decision did not hold. She was later indicted criminally for the death of her patient. She also had her nursing license revoked.
Why? The hospital where she worked was threatened with Medicare reprisal if systemic issues were not addressed following the incident; for example, a bar-coding device was not available for Ms. Vaught to use prior to administering the vecuronium, and paralytic agents were stored unsafely in a Pyxis MedStation, readily available for any nurse to obtain via override.
In fact, the number of overrides performed by all nurses caring for Ms. Murphey in the days leading to her death was alarming, leading reviewers to assume that time to acquire medication for inpatients was a problem.
Ms. Vaught herself, stating the obvious on talk shows, said she should not have performed an override, that the situation was “not an emergency” and she should have taken time to check that Versed (midazolam) was available by the generic name and not the “VE” she entered as a search mechanism into the machine. She also stated she was “distracted” by a trainee assigned to her at the time.
We have all been there, feeling rushed to perform a task under stressful situations, skipping safety guidelines to sedate a patient while radiology is waiting. Someone is always on our a**, waiting to get to the next task, the next patient, the next admission, the next pseudo-emergency called nursing workload.
It never ends.
Which is why I wish to emphasize what the Ms. Vaught guilty verdict really means for nurses.
It means we must never forget that our actions have the potential to harm, even kill, our patients.
We must never forget that repercussions and reprisal may occur, whether personal guilt that may prove more damaging than the prison sentence Ms. Vaught might receive, or problems that could result if nurses attempt to hide or subvert medication issues.
In Ms. Vaught’s case, she did not document the medication that had been given to Ms. Murphey, facts the prosecution seized on to proclaim her guilt. Why? We can only guess at this point. But her claims of truthfulness need to be balanced by what occurred, and the facts are that she did not document the error after administering vecuronium that night.
When reflecting on this verdict, we need to remember a patient died, and she did so horribly, being unable to draw breath. This should never happen during our watch, ever, and as clinicians, we need to be vigilant.
In summary, protest if you believe justice has been too harsh or unfair, and that nurses may be fearful as a result. But please spare a moment to realize that someone should protest for Ms. Murphey as well. We cannot bring her back, nor can we right the system issues that may have led to her death.
But we should protest for safer systems, for improved staffing, for a need to catch our collective breaths, and a day to work and nurture patients when someone is not constantly on our a**. Only then will nurses be protected from unjust reprisal, from needing to be the lowest common denominator of guilt.
Ms. Goodman is a researcher and consultant in Libertyville, Ill. She disclosed no conflicts of interest.
A version of this article first appeared on Medscape.com.
For 4 and a half years, I have followed the RaDonda Vaught medication error that led to the unfortunate death of a human being. I am not alone. Nurses across the country have followed the case with anxiety and fear, knowing a guilty verdict might have the potential to challenge basic tenets of care.
According to Kaiser Health News, nurses are “raging and quitting” following the announcement of a guilty verdict for two felonies: criminally negligent homicide and gross neglect of an impaired adult.
Thousands of nurses have claimed they could arrive in Nashville, Tenn., on May 13, the day Ms. Vaught is to be sentenced, to protest the conviction. Others have stated they believe justice is being conducted, as their sympathies lie with the victim, Charlene Murphey, who died 12 hours after being unable to draw breath, paralyzed from the inadvertent dose of vecuronium given intravenously by her nurse.
How should we feel as clinicians? according to sentencing guidelines?
My belief is that it is understandable to feel passionately about this case, including what it could mean to an era of “just culture” that nursing organizations have promoted. The concept of just culture looks at medication/nursing errors as opportunities for growth to avoid future errors, not as scenarios for punitive action. With the guilty verdict in Ms. Vaught’s case, nurses (and facilities) fear that nurses will avoid coming forward after mistakes, leading to cover-ups and a culture perspective.
Will nurses be hesitant to report errors (especially significant errors) that lead to patient harm? Will we fear retribution and reprisal for being truthful?
I believe that Ms. Vaught’s criminal case has changed little in the political landscape of caregiving. Before you let loose with a loud expletive (or two), hear me out.
When a patient dies from unintentional harm, someone must be held accountable. Society needs a scapegoat, and unfortunately, excrement slides downhill to the lowest common denominator, which may be the nurse. Initially, Ms. Vaught was contacted by her state licensing board (Tennessee) and informed there would be no professional repercussions for her mistake. That decision did not hold. She was later indicted criminally for the death of her patient. She also had her nursing license revoked.
Why? The hospital where she worked was threatened with Medicare reprisal if systemic issues were not addressed following the incident; for example, a bar-coding device was not available for Ms. Vaught to use prior to administering the vecuronium, and paralytic agents were stored unsafely in a Pyxis MedStation, readily available for any nurse to obtain via override.
In fact, the number of overrides performed by all nurses caring for Ms. Murphey in the days leading to her death was alarming, leading reviewers to assume that time to acquire medication for inpatients was a problem.
Ms. Vaught herself, stating the obvious on talk shows, said she should not have performed an override, that the situation was “not an emergency” and she should have taken time to check that Versed (midazolam) was available by the generic name and not the “VE” she entered as a search mechanism into the machine. She also stated she was “distracted” by a trainee assigned to her at the time.
We have all been there, feeling rushed to perform a task under stressful situations, skipping safety guidelines to sedate a patient while radiology is waiting. Someone is always on our a**, waiting to get to the next task, the next patient, the next admission, the next pseudo-emergency called nursing workload.
It never ends.
Which is why I wish to emphasize what the Ms. Vaught guilty verdict really means for nurses.
It means we must never forget that our actions have the potential to harm, even kill, our patients.
We must never forget that repercussions and reprisal may occur, whether personal guilt that may prove more damaging than the prison sentence Ms. Vaught might receive, or problems that could result if nurses attempt to hide or subvert medication issues.
In Ms. Vaught’s case, she did not document the medication that had been given to Ms. Murphey, facts the prosecution seized on to proclaim her guilt. Why? We can only guess at this point. But her claims of truthfulness need to be balanced by what occurred, and the facts are that she did not document the error after administering vecuronium that night.
When reflecting on this verdict, we need to remember a patient died, and she did so horribly, being unable to draw breath. This should never happen during our watch, ever, and as clinicians, we need to be vigilant.
In summary, protest if you believe justice has been too harsh or unfair, and that nurses may be fearful as a result. But please spare a moment to realize that someone should protest for Ms. Murphey as well. We cannot bring her back, nor can we right the system issues that may have led to her death.
But we should protest for safer systems, for improved staffing, for a need to catch our collective breaths, and a day to work and nurture patients when someone is not constantly on our a**. Only then will nurses be protected from unjust reprisal, from needing to be the lowest common denominator of guilt.
Ms. Goodman is a researcher and consultant in Libertyville, Ill. She disclosed no conflicts of interest.
A version of this article first appeared on Medscape.com.
For 4 and a half years, I have followed the RaDonda Vaught medication error that led to the unfortunate death of a human being. I am not alone. Nurses across the country have followed the case with anxiety and fear, knowing a guilty verdict might have the potential to challenge basic tenets of care.
According to Kaiser Health News, nurses are “raging and quitting” following the announcement of a guilty verdict for two felonies: criminally negligent homicide and gross neglect of an impaired adult.
Thousands of nurses have claimed they could arrive in Nashville, Tenn., on May 13, the day Ms. Vaught is to be sentenced, to protest the conviction. Others have stated they believe justice is being conducted, as their sympathies lie with the victim, Charlene Murphey, who died 12 hours after being unable to draw breath, paralyzed from the inadvertent dose of vecuronium given intravenously by her nurse.
How should we feel as clinicians? according to sentencing guidelines?
My belief is that it is understandable to feel passionately about this case, including what it could mean to an era of “just culture” that nursing organizations have promoted. The concept of just culture looks at medication/nursing errors as opportunities for growth to avoid future errors, not as scenarios for punitive action. With the guilty verdict in Ms. Vaught’s case, nurses (and facilities) fear that nurses will avoid coming forward after mistakes, leading to cover-ups and a culture perspective.
Will nurses be hesitant to report errors (especially significant errors) that lead to patient harm? Will we fear retribution and reprisal for being truthful?
I believe that Ms. Vaught’s criminal case has changed little in the political landscape of caregiving. Before you let loose with a loud expletive (or two), hear me out.
When a patient dies from unintentional harm, someone must be held accountable. Society needs a scapegoat, and unfortunately, excrement slides downhill to the lowest common denominator, which may be the nurse. Initially, Ms. Vaught was contacted by her state licensing board (Tennessee) and informed there would be no professional repercussions for her mistake. That decision did not hold. She was later indicted criminally for the death of her patient. She also had her nursing license revoked.
Why? The hospital where she worked was threatened with Medicare reprisal if systemic issues were not addressed following the incident; for example, a bar-coding device was not available for Ms. Vaught to use prior to administering the vecuronium, and paralytic agents were stored unsafely in a Pyxis MedStation, readily available for any nurse to obtain via override.
In fact, the number of overrides performed by all nurses caring for Ms. Murphey in the days leading to her death was alarming, leading reviewers to assume that time to acquire medication for inpatients was a problem.
Ms. Vaught herself, stating the obvious on talk shows, said she should not have performed an override, that the situation was “not an emergency” and she should have taken time to check that Versed (midazolam) was available by the generic name and not the “VE” she entered as a search mechanism into the machine. She also stated she was “distracted” by a trainee assigned to her at the time.
We have all been there, feeling rushed to perform a task under stressful situations, skipping safety guidelines to sedate a patient while radiology is waiting. Someone is always on our a**, waiting to get to the next task, the next patient, the next admission, the next pseudo-emergency called nursing workload.
It never ends.
Which is why I wish to emphasize what the Ms. Vaught guilty verdict really means for nurses.
It means we must never forget that our actions have the potential to harm, even kill, our patients.
We must never forget that repercussions and reprisal may occur, whether personal guilt that may prove more damaging than the prison sentence Ms. Vaught might receive, or problems that could result if nurses attempt to hide or subvert medication issues.
In Ms. Vaught’s case, she did not document the medication that had been given to Ms. Murphey, facts the prosecution seized on to proclaim her guilt. Why? We can only guess at this point. But her claims of truthfulness need to be balanced by what occurred, and the facts are that she did not document the error after administering vecuronium that night.
When reflecting on this verdict, we need to remember a patient died, and she did so horribly, being unable to draw breath. This should never happen during our watch, ever, and as clinicians, we need to be vigilant.
In summary, protest if you believe justice has been too harsh or unfair, and that nurses may be fearful as a result. But please spare a moment to realize that someone should protest for Ms. Murphey as well. We cannot bring her back, nor can we right the system issues that may have led to her death.
But we should protest for safer systems, for improved staffing, for a need to catch our collective breaths, and a day to work and nurture patients when someone is not constantly on our a**. Only then will nurses be protected from unjust reprisal, from needing to be the lowest common denominator of guilt.
Ms. Goodman is a researcher and consultant in Libertyville, Ill. She disclosed no conflicts of interest.
A version of this article first appeared on Medscape.com.
30% of COVID patients in study developed long COVID
University of California, Los Angeles, researchers said in a study published in the Journal of General Internal Medicine.
The UCLA researchers studied 1,038 people enrolled in the UCLA COVID Ambulatory Program between April 2020 and February 2021 and found that 309 developed long COVID.
A long-COVID diagnosis came if a patient answering a questionnaire reported persistent symptoms 60-90 days after they were infected or hospitalized. The most persistent symptoms were fatigue (31%) and shortness of breath (15%) in hospitalized participants. Among outpatients, 16% reported losing sense of smell.
The study’s findings differ from earlier research. The University of California, Davis, for example, estimated that 10% of COVID-19 patients develop long-haul symptoms. A 2021 study from Penn State University found that more than half of worldwide COVID-19 patients would develop long COVID.
Part of the discrepancy can blamed on the fact there is no official, widely accepted definition of long COVID. The Centers for Disease Control and Prevention has said it means patients who experience “new, returning, or ongoing health problems 4 or more weeks after an initial infection” the coronavirus. The UCLA study, meanwhile, included patients still having symptoms 60-90 days after infection.
Still, the UCLA research team looked at demographics and clinical characteristics in an attempt to develop effective treatments.
People with a history of hospitalization, diabetes, and higher body mass index were most likely to develop long COVID, the researchers said. The kind of insurance the patients had also seemed to be a factor, though the researchers didn’t offer a reason why.
“Surprisingly, patients with commercial insurance had double the likelihood of developing [long COVID] compared to patients with Medicaid,” they wrote. “This association will be important to explore further to understand if insurance status in this group is representing unmeasured demographic factors or exposures.”
Older age and socioeconomic status were not associated with long COVID in the study – a surprise because those characteristics are often linked with severe illness and higher risk of death from COVID-19.
Weaknesses in the study included the subjective nature of how patients rated their symptoms and the limited number of symptoms evaluated.
“This study illustrates the need to follow diverse patient populations ... to understand the long COVID disease trajectory and evaluate how individual factors such as preexisting comorbidities, sociodemographic factors, vaccination status and virus variant type affect type and persistence of long COVID symptoms,” said Sun Yoo, MD, health sciences assistant clinical professor at UCLA.
A version of this article first appeared on WebMD.com.
University of California, Los Angeles, researchers said in a study published in the Journal of General Internal Medicine.
The UCLA researchers studied 1,038 people enrolled in the UCLA COVID Ambulatory Program between April 2020 and February 2021 and found that 309 developed long COVID.
A long-COVID diagnosis came if a patient answering a questionnaire reported persistent symptoms 60-90 days after they were infected or hospitalized. The most persistent symptoms were fatigue (31%) and shortness of breath (15%) in hospitalized participants. Among outpatients, 16% reported losing sense of smell.
The study’s findings differ from earlier research. The University of California, Davis, for example, estimated that 10% of COVID-19 patients develop long-haul symptoms. A 2021 study from Penn State University found that more than half of worldwide COVID-19 patients would develop long COVID.
Part of the discrepancy can blamed on the fact there is no official, widely accepted definition of long COVID. The Centers for Disease Control and Prevention has said it means patients who experience “new, returning, or ongoing health problems 4 or more weeks after an initial infection” the coronavirus. The UCLA study, meanwhile, included patients still having symptoms 60-90 days after infection.
Still, the UCLA research team looked at demographics and clinical characteristics in an attempt to develop effective treatments.
People with a history of hospitalization, diabetes, and higher body mass index were most likely to develop long COVID, the researchers said. The kind of insurance the patients had also seemed to be a factor, though the researchers didn’t offer a reason why.
“Surprisingly, patients with commercial insurance had double the likelihood of developing [long COVID] compared to patients with Medicaid,” they wrote. “This association will be important to explore further to understand if insurance status in this group is representing unmeasured demographic factors or exposures.”
Older age and socioeconomic status were not associated with long COVID in the study – a surprise because those characteristics are often linked with severe illness and higher risk of death from COVID-19.
Weaknesses in the study included the subjective nature of how patients rated their symptoms and the limited number of symptoms evaluated.
“This study illustrates the need to follow diverse patient populations ... to understand the long COVID disease trajectory and evaluate how individual factors such as preexisting comorbidities, sociodemographic factors, vaccination status and virus variant type affect type and persistence of long COVID symptoms,” said Sun Yoo, MD, health sciences assistant clinical professor at UCLA.
A version of this article first appeared on WebMD.com.
University of California, Los Angeles, researchers said in a study published in the Journal of General Internal Medicine.
The UCLA researchers studied 1,038 people enrolled in the UCLA COVID Ambulatory Program between April 2020 and February 2021 and found that 309 developed long COVID.
A long-COVID diagnosis came if a patient answering a questionnaire reported persistent symptoms 60-90 days after they were infected or hospitalized. The most persistent symptoms were fatigue (31%) and shortness of breath (15%) in hospitalized participants. Among outpatients, 16% reported losing sense of smell.
The study’s findings differ from earlier research. The University of California, Davis, for example, estimated that 10% of COVID-19 patients develop long-haul symptoms. A 2021 study from Penn State University found that more than half of worldwide COVID-19 patients would develop long COVID.
Part of the discrepancy can blamed on the fact there is no official, widely accepted definition of long COVID. The Centers for Disease Control and Prevention has said it means patients who experience “new, returning, or ongoing health problems 4 or more weeks after an initial infection” the coronavirus. The UCLA study, meanwhile, included patients still having symptoms 60-90 days after infection.
Still, the UCLA research team looked at demographics and clinical characteristics in an attempt to develop effective treatments.
People with a history of hospitalization, diabetes, and higher body mass index were most likely to develop long COVID, the researchers said. The kind of insurance the patients had also seemed to be a factor, though the researchers didn’t offer a reason why.
“Surprisingly, patients with commercial insurance had double the likelihood of developing [long COVID] compared to patients with Medicaid,” they wrote. “This association will be important to explore further to understand if insurance status in this group is representing unmeasured demographic factors or exposures.”
Older age and socioeconomic status were not associated with long COVID in the study – a surprise because those characteristics are often linked with severe illness and higher risk of death from COVID-19.
Weaknesses in the study included the subjective nature of how patients rated their symptoms and the limited number of symptoms evaluated.
“This study illustrates the need to follow diverse patient populations ... to understand the long COVID disease trajectory and evaluate how individual factors such as preexisting comorbidities, sociodemographic factors, vaccination status and virus variant type affect type and persistence of long COVID symptoms,” said Sun Yoo, MD, health sciences assistant clinical professor at UCLA.
A version of this article first appeared on WebMD.com.
FROM THE JOURNAL OF GENERAL INTERNAL MEDICINE
The Empire strikes out against one physician’s homemade star fighter
The force is with Ukraine, always
Of all the things we could want from Star Wars, a lightsaber is at the top of the list. And someone is working on that. But second is probably the iconic X-wing. It was used to blow up the Death Star after all: Who wouldn’t want one?
A real-life star fighter may be outside our technological capabilities, but Dr. Akaki Lekiachvili of Atlanta has done the next best thing and constructed a two-thirds scale model to encourage kids to enter the sciences and, with the advent of the war in Ukraine, raise money for medical supplies to assist doctors in the embattled country. Perhaps unsurprisingly, Dr. Lekiachvili, originally from Georgia (the country, former Soviet republic, and previous target of Russian aggression in 2008), takes a dim view toward the invasion of Ukraine: “Russia is like the Evil Empire and Ukraine the Rebel Alliance.”
It’s been a long road finishing the X-Wing, as Dr. Lekiachvili started the project in 2016 and spent $60,000 on it, posting numerous updates on social media over that time, even attracting the attention of Luke Skywalker himself, actor Mark Hamill. Now that he’s done, he’s brought his model out to the public multiple times, delighting kids and adults alike. It can’t fly, but it has an engine and wheels so it can move, the wings can lock into attack position, the thrusters light up, and the voices of Obi-Wan Kenobi and R2-D2 guide children along as they sit in the cockpit.
Dr. Lekiachvili hopes to auction off his creation to a collector and donate the proceeds to Ukrainian charities, and we’re sure he’ll receive far more than the $60,000 he spent building his masterpiece. Now, if you’ll excuse us, we’re off to raid our bank accounts. We have a Death Star to destroy.
I’m a doctor, not a hologram
Telemedicine got a big boost during the early phase of the pandemic when hospitals and medical offices were off limits to anyone without COVID-19, but things have cooled off, telemedically speaking, since then. Well, NASA may have heated them up again. Or maybe it was Starfleet. Hmm, wait a second while we check. … No, it was NASA.
The space agency used the Microsoft Hololens Kinect camera and a personal computer with custom software from Aexa Aerospace to “holoport” NASA flight surgeon Josef Schmid up to the International Space Station, where he had a conversation with European Space Agency astronaut Thomas Pesquet, who wore an augmented reality headset that allowed him to see, hear, and interact with a 3D representation of the earthbound medical provider.
“Holoportation has been in use since at least 2016 by Microsoft, but this is the first use in such an extreme and remote environment such as space,” NASA said in a recent written statement, noting that the extreme house call took place on Oct. 8, 2021.
They seem to be forgetting about Star Trek, but we’ll let them slide on that one. Anyway, NASA didn’t share any details of the medical holoconversation – which may have strained the limits of HIPAA’s portability provisions – but Dr. Schmid described it as “a brand-new way of human exploration, where our human entity is able to travel off the planet. Our physical body is not there, but our human entity absolutely is there.”
Boldly doctoring where no doctor has gone before, you might say. You also might notice from the photo that Dr. Schmid went full Trekkie with a genuine Vulcan salute. Live long and prosper, Dr. Schmid. Live long and prosper.
Add electricity for umami
Salt makes everything taste better. Unfortunately, excess salt can cause problems for our bodies down the line, starting with high blood pressure and continuing on to heart disease and strokes. So how do we enjoy our deliciously salty foods without putting ourselves at risk? One answer may be electricity.
Researchers at Meiji University in Tokyo partnered with food and beverage maker Kirin to develop a set of electric chopsticks to boost the taste of salt in foods without the extra sodium. According to codeveloper and Meiji University professor Homei Miyashita, the device, worn like a watch with a wire attached to one of the chopsticks, “uses a weak electrical current to transmit sodium ions from food, through the chopsticks, to the mouth where they create a sense of saltines,” Reuters said.
In a country like Japan, where a lot of food is made with heavily sodium-based ingredients like miso and soy sauce, the average adult consumes 10 g of salt a day. That’s twice the recommended amount proposed by the World Health Organization. To not sacrifice bland food for better health, this device, which enhances the saltiness of the food consumed by 1.5 times, offers a fairly easy solution to a big public health crisis.
The chopsticks were tested by giving participants reduced-sodium miso soup. They told the researchers that the food was improved in “richness, sweetness, and overall tastiness,” the Guardian said.
Worried about having something electric in your mouth? Don’t worry. Kirin said in a statement that the electricity is very weak and not enough to affect the body.
The chopsticks are still in a prototype stage, but you may be able to get your pair as soon as next year. Until then, maybe be a little mindful of the salt.
Pet poop works in mysterious ways
We usually see it as a burden when our pets poop and pee in the house, but those bodily excretions may be able to tell us something about cancer-causing toxins running rampant in our homes.
Those toxins, known as aromatic amines, can be found in tobacco smoke and dyes used in make-up, textiles, and plastics. “Our findings suggest that pets are coming into contact with aromatic amines that leach from products in their household environment,” lead author Sridhar Chinthakindi, PhD, of NYU Langone Health, said in a statement from the university. “As these substances have been tied to bladder, colorectal, and other forms of cancer, our results may help explain why so many dogs and cats develop such diseases.”
Tobacco smoke was not the main source of the aromatic amines found in the poop and urine, but 70% of dogs and 80% of cats had these chemicals in their waste. The researchers looked for 30 types of aromatic amines plus nicotine in the sample and found 8. The chemical concentrations were much higher in cats than in dogs, possibly because of differences in exposure and metabolism between the two species, they suggested.
“If [pets] are getting exposed to toxins in our homes, then we had better take a closer look at our own exposure,” said senior author Kurunthachalam Kannan, PhD, of NYU Langone.
So the next time your pet poops or pees in the house, don’t get mad. Maybe they’re just trying to help you out by supplying some easy-to-collect samples.
The force is with Ukraine, always
Of all the things we could want from Star Wars, a lightsaber is at the top of the list. And someone is working on that. But second is probably the iconic X-wing. It was used to blow up the Death Star after all: Who wouldn’t want one?
A real-life star fighter may be outside our technological capabilities, but Dr. Akaki Lekiachvili of Atlanta has done the next best thing and constructed a two-thirds scale model to encourage kids to enter the sciences and, with the advent of the war in Ukraine, raise money for medical supplies to assist doctors in the embattled country. Perhaps unsurprisingly, Dr. Lekiachvili, originally from Georgia (the country, former Soviet republic, and previous target of Russian aggression in 2008), takes a dim view toward the invasion of Ukraine: “Russia is like the Evil Empire and Ukraine the Rebel Alliance.”
It’s been a long road finishing the X-Wing, as Dr. Lekiachvili started the project in 2016 and spent $60,000 on it, posting numerous updates on social media over that time, even attracting the attention of Luke Skywalker himself, actor Mark Hamill. Now that he’s done, he’s brought his model out to the public multiple times, delighting kids and adults alike. It can’t fly, but it has an engine and wheels so it can move, the wings can lock into attack position, the thrusters light up, and the voices of Obi-Wan Kenobi and R2-D2 guide children along as they sit in the cockpit.
Dr. Lekiachvili hopes to auction off his creation to a collector and donate the proceeds to Ukrainian charities, and we’re sure he’ll receive far more than the $60,000 he spent building his masterpiece. Now, if you’ll excuse us, we’re off to raid our bank accounts. We have a Death Star to destroy.
I’m a doctor, not a hologram
Telemedicine got a big boost during the early phase of the pandemic when hospitals and medical offices were off limits to anyone without COVID-19, but things have cooled off, telemedically speaking, since then. Well, NASA may have heated them up again. Or maybe it was Starfleet. Hmm, wait a second while we check. … No, it was NASA.
The space agency used the Microsoft Hololens Kinect camera and a personal computer with custom software from Aexa Aerospace to “holoport” NASA flight surgeon Josef Schmid up to the International Space Station, where he had a conversation with European Space Agency astronaut Thomas Pesquet, who wore an augmented reality headset that allowed him to see, hear, and interact with a 3D representation of the earthbound medical provider.
“Holoportation has been in use since at least 2016 by Microsoft, but this is the first use in such an extreme and remote environment such as space,” NASA said in a recent written statement, noting that the extreme house call took place on Oct. 8, 2021.
They seem to be forgetting about Star Trek, but we’ll let them slide on that one. Anyway, NASA didn’t share any details of the medical holoconversation – which may have strained the limits of HIPAA’s portability provisions – but Dr. Schmid described it as “a brand-new way of human exploration, where our human entity is able to travel off the planet. Our physical body is not there, but our human entity absolutely is there.”
Boldly doctoring where no doctor has gone before, you might say. You also might notice from the photo that Dr. Schmid went full Trekkie with a genuine Vulcan salute. Live long and prosper, Dr. Schmid. Live long and prosper.
Add electricity for umami
Salt makes everything taste better. Unfortunately, excess salt can cause problems for our bodies down the line, starting with high blood pressure and continuing on to heart disease and strokes. So how do we enjoy our deliciously salty foods without putting ourselves at risk? One answer may be electricity.
Researchers at Meiji University in Tokyo partnered with food and beverage maker Kirin to develop a set of electric chopsticks to boost the taste of salt in foods without the extra sodium. According to codeveloper and Meiji University professor Homei Miyashita, the device, worn like a watch with a wire attached to one of the chopsticks, “uses a weak electrical current to transmit sodium ions from food, through the chopsticks, to the mouth where they create a sense of saltines,” Reuters said.
In a country like Japan, where a lot of food is made with heavily sodium-based ingredients like miso and soy sauce, the average adult consumes 10 g of salt a day. That’s twice the recommended amount proposed by the World Health Organization. To not sacrifice bland food for better health, this device, which enhances the saltiness of the food consumed by 1.5 times, offers a fairly easy solution to a big public health crisis.
The chopsticks were tested by giving participants reduced-sodium miso soup. They told the researchers that the food was improved in “richness, sweetness, and overall tastiness,” the Guardian said.
Worried about having something electric in your mouth? Don’t worry. Kirin said in a statement that the electricity is very weak and not enough to affect the body.
The chopsticks are still in a prototype stage, but you may be able to get your pair as soon as next year. Until then, maybe be a little mindful of the salt.
Pet poop works in mysterious ways
We usually see it as a burden when our pets poop and pee in the house, but those bodily excretions may be able to tell us something about cancer-causing toxins running rampant in our homes.
Those toxins, known as aromatic amines, can be found in tobacco smoke and dyes used in make-up, textiles, and plastics. “Our findings suggest that pets are coming into contact with aromatic amines that leach from products in their household environment,” lead author Sridhar Chinthakindi, PhD, of NYU Langone Health, said in a statement from the university. “As these substances have been tied to bladder, colorectal, and other forms of cancer, our results may help explain why so many dogs and cats develop such diseases.”
Tobacco smoke was not the main source of the aromatic amines found in the poop and urine, but 70% of dogs and 80% of cats had these chemicals in their waste. The researchers looked for 30 types of aromatic amines plus nicotine in the sample and found 8. The chemical concentrations were much higher in cats than in dogs, possibly because of differences in exposure and metabolism between the two species, they suggested.
“If [pets] are getting exposed to toxins in our homes, then we had better take a closer look at our own exposure,” said senior author Kurunthachalam Kannan, PhD, of NYU Langone.
So the next time your pet poops or pees in the house, don’t get mad. Maybe they’re just trying to help you out by supplying some easy-to-collect samples.
The force is with Ukraine, always
Of all the things we could want from Star Wars, a lightsaber is at the top of the list. And someone is working on that. But second is probably the iconic X-wing. It was used to blow up the Death Star after all: Who wouldn’t want one?
A real-life star fighter may be outside our technological capabilities, but Dr. Akaki Lekiachvili of Atlanta has done the next best thing and constructed a two-thirds scale model to encourage kids to enter the sciences and, with the advent of the war in Ukraine, raise money for medical supplies to assist doctors in the embattled country. Perhaps unsurprisingly, Dr. Lekiachvili, originally from Georgia (the country, former Soviet republic, and previous target of Russian aggression in 2008), takes a dim view toward the invasion of Ukraine: “Russia is like the Evil Empire and Ukraine the Rebel Alliance.”
It’s been a long road finishing the X-Wing, as Dr. Lekiachvili started the project in 2016 and spent $60,000 on it, posting numerous updates on social media over that time, even attracting the attention of Luke Skywalker himself, actor Mark Hamill. Now that he’s done, he’s brought his model out to the public multiple times, delighting kids and adults alike. It can’t fly, but it has an engine and wheels so it can move, the wings can lock into attack position, the thrusters light up, and the voices of Obi-Wan Kenobi and R2-D2 guide children along as they sit in the cockpit.
Dr. Lekiachvili hopes to auction off his creation to a collector and donate the proceeds to Ukrainian charities, and we’re sure he’ll receive far more than the $60,000 he spent building his masterpiece. Now, if you’ll excuse us, we’re off to raid our bank accounts. We have a Death Star to destroy.
I’m a doctor, not a hologram
Telemedicine got a big boost during the early phase of the pandemic when hospitals and medical offices were off limits to anyone without COVID-19, but things have cooled off, telemedically speaking, since then. Well, NASA may have heated them up again. Or maybe it was Starfleet. Hmm, wait a second while we check. … No, it was NASA.
The space agency used the Microsoft Hololens Kinect camera and a personal computer with custom software from Aexa Aerospace to “holoport” NASA flight surgeon Josef Schmid up to the International Space Station, where he had a conversation with European Space Agency astronaut Thomas Pesquet, who wore an augmented reality headset that allowed him to see, hear, and interact with a 3D representation of the earthbound medical provider.
“Holoportation has been in use since at least 2016 by Microsoft, but this is the first use in such an extreme and remote environment such as space,” NASA said in a recent written statement, noting that the extreme house call took place on Oct. 8, 2021.
They seem to be forgetting about Star Trek, but we’ll let them slide on that one. Anyway, NASA didn’t share any details of the medical holoconversation – which may have strained the limits of HIPAA’s portability provisions – but Dr. Schmid described it as “a brand-new way of human exploration, where our human entity is able to travel off the planet. Our physical body is not there, but our human entity absolutely is there.”
Boldly doctoring where no doctor has gone before, you might say. You also might notice from the photo that Dr. Schmid went full Trekkie with a genuine Vulcan salute. Live long and prosper, Dr. Schmid. Live long and prosper.
Add electricity for umami
Salt makes everything taste better. Unfortunately, excess salt can cause problems for our bodies down the line, starting with high blood pressure and continuing on to heart disease and strokes. So how do we enjoy our deliciously salty foods without putting ourselves at risk? One answer may be electricity.
Researchers at Meiji University in Tokyo partnered with food and beverage maker Kirin to develop a set of electric chopsticks to boost the taste of salt in foods without the extra sodium. According to codeveloper and Meiji University professor Homei Miyashita, the device, worn like a watch with a wire attached to one of the chopsticks, “uses a weak electrical current to transmit sodium ions from food, through the chopsticks, to the mouth where they create a sense of saltines,” Reuters said.
In a country like Japan, where a lot of food is made with heavily sodium-based ingredients like miso and soy sauce, the average adult consumes 10 g of salt a day. That’s twice the recommended amount proposed by the World Health Organization. To not sacrifice bland food for better health, this device, which enhances the saltiness of the food consumed by 1.5 times, offers a fairly easy solution to a big public health crisis.
The chopsticks were tested by giving participants reduced-sodium miso soup. They told the researchers that the food was improved in “richness, sweetness, and overall tastiness,” the Guardian said.
Worried about having something electric in your mouth? Don’t worry. Kirin said in a statement that the electricity is very weak and not enough to affect the body.
The chopsticks are still in a prototype stage, but you may be able to get your pair as soon as next year. Until then, maybe be a little mindful of the salt.
Pet poop works in mysterious ways
We usually see it as a burden when our pets poop and pee in the house, but those bodily excretions may be able to tell us something about cancer-causing toxins running rampant in our homes.
Those toxins, known as aromatic amines, can be found in tobacco smoke and dyes used in make-up, textiles, and plastics. “Our findings suggest that pets are coming into contact with aromatic amines that leach from products in their household environment,” lead author Sridhar Chinthakindi, PhD, of NYU Langone Health, said in a statement from the university. “As these substances have been tied to bladder, colorectal, and other forms of cancer, our results may help explain why so many dogs and cats develop such diseases.”
Tobacco smoke was not the main source of the aromatic amines found in the poop and urine, but 70% of dogs and 80% of cats had these chemicals in their waste. The researchers looked for 30 types of aromatic amines plus nicotine in the sample and found 8. The chemical concentrations were much higher in cats than in dogs, possibly because of differences in exposure and metabolism between the two species, they suggested.
“If [pets] are getting exposed to toxins in our homes, then we had better take a closer look at our own exposure,” said senior author Kurunthachalam Kannan, PhD, of NYU Langone.
So the next time your pet poops or pees in the house, don’t get mad. Maybe they’re just trying to help you out by supplying some easy-to-collect samples.
FDA warns companies selling OTC skin lighteners
The as the active ingredient, and don’t meet the requirements to be sold legally over the counter. The letters were dated April 13.
The 12 products with hydroquinone are “unapproved drugs and are not generally recognized as safe and effective” (abbreviated as GRASE), the FDA said.
Among the side effects associated with hydroquinone products reported to the FDA are skin rashes, facial swelling, and skin discoloration or ochronosis. The discoloration can be permanent, the FDA said. The lighteners are marketed for use on age or dark spots on the skin associated with melasma.
Tri-Luma, a prescription product for the treatment of moderate to severe melasma of the face, is the only FDA-approved drug containing hydroquinone, according to the FDA. It contains 4% hydroquinone and two other ingredients. It is meant to be used under the supervision of a health care professional. Tri-Luma is indicated for up to 8 weeks of treatment for moderate to severe melasma of the face. The OTC products contain up to 2%. (Generic versions of 4% hydroquinone are available by prescription, dermatologists said.)
“Hydroquinone is a very effective medication, and that’s exactly what it is, a medication,” said Lily Talakoub, MD, a dermatologist in McLean, Va., who supports the FDA action. “It’s very effective and very safe to use in the right hands, but when it is overused or used in the wrong situation, it can cause problems.” Those problems often occur, she said, when there is no health care professional overseeing the use of the OTC products, and when people use them over the long term.
The FDA action to ban the OTC products is “very appropriate,” said dermatologist Pooja Sodha, MD, assistant professor and director of the Center for Laser and Cosmetic Dermatology at George Washington University, Washington. “We know patients pick this up [an OTC product] and use it without physician oversight.” When patients use the products longer than is appropriate, which is also common, it can worsen the initial skin issue, she said.
The action follows reforms finalized under the CARES Act (Coronavirus Aid, Relief and Economic Security Act), which included not only COVID-19 response efforts but also updated the method in which certain OTC drugs are regulated. Manufacturers of the skin lightening products that don’t have FDA approval had been told to remove the products from the market by September 2020.
The recent letters were sent to a dozen companies still marketing their products without an FDA new drug approval. The agency asked the companies to take prompt action and respond with 15 days, stating what they have done to correct the violations.
The 12 companies are AMBI Enterprises, Clinical Formula, Elements Brands Inc., Genomma Lab USA, Intilight/Dr Thomas Balshi, M&M Beauty and Wellness, Neoteric Cosmetics/Scott’s Liquid Gold, Skin Authority, Skin Pro, Skin PS Brands, True Earth Health Products, and Ultimark Products.
Health care professionals and consumers can report adverse reactions associated with these products to the FDA’s MedWatch Adverse Event Reporting program.
A version of this article first appeared on Medscape.com.
The as the active ingredient, and don’t meet the requirements to be sold legally over the counter. The letters were dated April 13.
The 12 products with hydroquinone are “unapproved drugs and are not generally recognized as safe and effective” (abbreviated as GRASE), the FDA said.
Among the side effects associated with hydroquinone products reported to the FDA are skin rashes, facial swelling, and skin discoloration or ochronosis. The discoloration can be permanent, the FDA said. The lighteners are marketed for use on age or dark spots on the skin associated with melasma.
Tri-Luma, a prescription product for the treatment of moderate to severe melasma of the face, is the only FDA-approved drug containing hydroquinone, according to the FDA. It contains 4% hydroquinone and two other ingredients. It is meant to be used under the supervision of a health care professional. Tri-Luma is indicated for up to 8 weeks of treatment for moderate to severe melasma of the face. The OTC products contain up to 2%. (Generic versions of 4% hydroquinone are available by prescription, dermatologists said.)
“Hydroquinone is a very effective medication, and that’s exactly what it is, a medication,” said Lily Talakoub, MD, a dermatologist in McLean, Va., who supports the FDA action. “It’s very effective and very safe to use in the right hands, but when it is overused or used in the wrong situation, it can cause problems.” Those problems often occur, she said, when there is no health care professional overseeing the use of the OTC products, and when people use them over the long term.
The FDA action to ban the OTC products is “very appropriate,” said dermatologist Pooja Sodha, MD, assistant professor and director of the Center for Laser and Cosmetic Dermatology at George Washington University, Washington. “We know patients pick this up [an OTC product] and use it without physician oversight.” When patients use the products longer than is appropriate, which is also common, it can worsen the initial skin issue, she said.
The action follows reforms finalized under the CARES Act (Coronavirus Aid, Relief and Economic Security Act), which included not only COVID-19 response efforts but also updated the method in which certain OTC drugs are regulated. Manufacturers of the skin lightening products that don’t have FDA approval had been told to remove the products from the market by September 2020.
The recent letters were sent to a dozen companies still marketing their products without an FDA new drug approval. The agency asked the companies to take prompt action and respond with 15 days, stating what they have done to correct the violations.
The 12 companies are AMBI Enterprises, Clinical Formula, Elements Brands Inc., Genomma Lab USA, Intilight/Dr Thomas Balshi, M&M Beauty and Wellness, Neoteric Cosmetics/Scott’s Liquid Gold, Skin Authority, Skin Pro, Skin PS Brands, True Earth Health Products, and Ultimark Products.
Health care professionals and consumers can report adverse reactions associated with these products to the FDA’s MedWatch Adverse Event Reporting program.
A version of this article first appeared on Medscape.com.
The as the active ingredient, and don’t meet the requirements to be sold legally over the counter. The letters were dated April 13.
The 12 products with hydroquinone are “unapproved drugs and are not generally recognized as safe and effective” (abbreviated as GRASE), the FDA said.
Among the side effects associated with hydroquinone products reported to the FDA are skin rashes, facial swelling, and skin discoloration or ochronosis. The discoloration can be permanent, the FDA said. The lighteners are marketed for use on age or dark spots on the skin associated with melasma.
Tri-Luma, a prescription product for the treatment of moderate to severe melasma of the face, is the only FDA-approved drug containing hydroquinone, according to the FDA. It contains 4% hydroquinone and two other ingredients. It is meant to be used under the supervision of a health care professional. Tri-Luma is indicated for up to 8 weeks of treatment for moderate to severe melasma of the face. The OTC products contain up to 2%. (Generic versions of 4% hydroquinone are available by prescription, dermatologists said.)
“Hydroquinone is a very effective medication, and that’s exactly what it is, a medication,” said Lily Talakoub, MD, a dermatologist in McLean, Va., who supports the FDA action. “It’s very effective and very safe to use in the right hands, but when it is overused or used in the wrong situation, it can cause problems.” Those problems often occur, she said, when there is no health care professional overseeing the use of the OTC products, and when people use them over the long term.
The FDA action to ban the OTC products is “very appropriate,” said dermatologist Pooja Sodha, MD, assistant professor and director of the Center for Laser and Cosmetic Dermatology at George Washington University, Washington. “We know patients pick this up [an OTC product] and use it without physician oversight.” When patients use the products longer than is appropriate, which is also common, it can worsen the initial skin issue, she said.
The action follows reforms finalized under the CARES Act (Coronavirus Aid, Relief and Economic Security Act), which included not only COVID-19 response efforts but also updated the method in which certain OTC drugs are regulated. Manufacturers of the skin lightening products that don’t have FDA approval had been told to remove the products from the market by September 2020.
The recent letters were sent to a dozen companies still marketing their products without an FDA new drug approval. The agency asked the companies to take prompt action and respond with 15 days, stating what they have done to correct the violations.
The 12 companies are AMBI Enterprises, Clinical Formula, Elements Brands Inc., Genomma Lab USA, Intilight/Dr Thomas Balshi, M&M Beauty and Wellness, Neoteric Cosmetics/Scott’s Liquid Gold, Skin Authority, Skin Pro, Skin PS Brands, True Earth Health Products, and Ultimark Products.
Health care professionals and consumers can report adverse reactions associated with these products to the FDA’s MedWatch Adverse Event Reporting program.
A version of this article first appeared on Medscape.com.
Hormones after cancer: Are they safe?
The impact of a gynecologic cancer diagnosis reaches beyond the obvious side effects of surgery, chemotherapy, and radiation. Many of our patients experience the quality-of-life–limiting side effects of abrupt hormone withdrawal as a consequence of our treatments. Assumptions are common, by both patients and providers, that hormonal therapy is unsafe after a gynecologic cancer diagnosis and that it is associated with an increased risk for recurrence. This sentiment likely originates from the fallout of the Womens’ Health Initiative (WHI) studies which showed an increased risk of breast cancer among users of combined estrogen and progesterone therapy.1 While this may be true for breast cancer risk, when initiated early, hormonal therapy is safe, even beneficial, for many patients with a history of gynecologic cancer, and can significantly improve their quality of life in addition to reducing all-cause mortality and incidence of osteoporosis, dementia, and cardiovascular disease.2
Premenopausal women undergoing surgery for endometrial cancer or preinvasive hyperplasia should be considered for ovarian preservation at the time of surgery. This strategy has been shown to be safe and not associated with an increased risk of recurrence. If oophorectomy is performed, hormonal therapy has been shown to be a safe remedy to the side effects of surgical menopause and the deleterious acceleration of bone loss and cardiovascular aging. The safety of hormone therapy for early-stage endometrial cancer has been thoroughly studied, including in a randomized controlled trial of more than 1,200 patients.3 This study showed no difference in the recurrence rate in users when compared with nonusers.
While hormone therapy is safe, from an oncologic standpoint, for women with a history of early-stage endometrial cancer other risks must also be considered. Given the association between endometrial cancer and obesity, these patients are at higher risk for venous thromboembolic (VTE) events, more so with the addition of exogenous hormone therapy. While not an overt contraindication to hormone prescription, obese patients who are prescribed these agents should be counseled regarding their risks for VTE.
The subgroup of patients with endometrial cancer in whom hormones should not be prescribed are those with advanced or recurrent disease. It is common for these tumors to express estrogen receptors, as evidenced by the responsiveness of these tumors to progesterone and antiestrogen treatments. Therefore, there is a theoretical risk for progression while using estrogen. In addition, as stated above, the risk of VTE is particularly elevated for women with metastatic malignancy receiving systemic therapies.
Cervical cancer commonly affects women of premenopausal age; therefore, early ovarian failure is particularly deleterious for this group of patients. Early-stage cervical cancer is most commonly treated with radical or extrafascial hysterectomy. Oophorectomy is not obligatory for the majority of these cases, and can be omitted in pre-, or perimenopausal patients to prevent surgical menopause. Ovarian metastases have been reported in cases of cervical adenocarcinoma, which led to the concern that ovarian preservation was not safe for this histology. However, recent data dispute this concern. A contemporary retrospective series of 105 patients with cervical adenocarcinoma identified no significant difference in overall survival when comparing those who had undergone ovarian preservation versus bilateral salpingo-oophorectomy.4
Ovarian preservation during cervical cancer surgery may not be enough to prevent early menopause. Approximately 20% of cervical cancer patients may require postoperative radiation for high- or intermediate-risk disease (such as positive lymph nodes, or adverse features in the tumor). For these women, ovarian ablation results, even if the ovaries were preserved at the time of surgery. Transposition of the ovaries to a location outside of the potential radiation fields is a strategy to mitigate this risk. To achieve this, the preserved ovaries and their vascular pedicles are skeletonized. The ovaries are then sutured to the paracolic gutter peritoneum or similar location above the pelvic brim, taking care to ensure that the vascular pedicle is not compromised or twisted. Placement of radio-opaque surgical clips on the caudad aspect of the transposed ovary aids in their identification by radiation oncologists when planning their treatment fields.
Ovarian transposition is most commonly used for women who are undergoing definitive surgery for cervical cancer. However, this strategy can also be used as a lead-in procedure for young women with advanced cervical cancer in whom definitive chemoradiation is planned. If the ovaries cannot be spared or moved out of “harm’s way” for premenopausal women undergoing treatment with definitive radiation, hormone therapy may be necessary and is safe for patients with cervical cancer, including those with adenocarcinoma. If the patient has not undergone hysterectomy, a regimen that includes a combination of estrogen and progesterone is necessary to avoid carcinogenic effects of unopposed estrogen on an intact endometrium, even after radiation has ablated those tissues.
When ovarian and fallopian cancers arise in premenopausal patients and appear confined to a single adnexa, contralateral ovarian preservation can be considered. However, for advanced disease, this is usually not possible or appropriate. Given that most ovarian cancers arise in a postmenopausal population, these patients may be preexisting users of hormone therapy. The data, including a randomized controlled trial, would suggest that it is safe to continue to use hormone therapy during or following a diagnosis of ovarian, fallopian tube, or primary peritoneal cancer and that it is not associated with worse outcomes from their cancer.5
Once again, patients should be carefully counseled about the additive risks for VTE that come from metastatic ovarian cancer, surgery via laparotomy, and exogenous hormonal therapy. However, these patients need not be subjected to an abrupt transition to menopause, because level I evidence suggests that these therapies are not associated with worse oncologic outcomes. All patients with ovarian, fallopian tube, and primary peritoneal cancer should receive genetic testing, and if deleterious mutations are found in BRCA 1 or 2 genes indicating an elevated risk for breast cancer, decision making regarding continued exogenous hormonal therapy is complicated. The most contemporary data, including long-term follow-up from the Women’s Health Initiative clinical trials, do not suggest an increased risk for breast cancer with estrogen-only preparations of hormone therapy.6 Given that most women with gynecologic cancers have undergone hysterectomy as part of their treatment, these estrogen-only preparations are appropriate for most.
For patients with rare tumors, such as endometrial stromal tumors or uterine leiomyosarcoma, the safety of exogenous hormone therapy should be dictated by the receptor profile of their particular cancer. Many of these cancers express estrogen receptors; therefore, current guidelines recommend against the use of hormones after these diagnoses when estrogen receptors are expressed.
Gynecologic cancer treatments induce many toxicities with long-term deleterious effects on quality of life. Use of hormones to mitigate the symptoms of menopause is an important tool in the toolkit for gynecologists. Assumptions should not be made that hormonal therapies are always unsafe for all of these patients. It is important to closely evaluate the patient’s tumor and other risk factors before withholding potentially valuable therapies.
Dr. Rossi is assistant professor in the division of gynecologic oncology at the University of North Carolina at Chapel Hill. She has no relevant financial disclosures. Email her at [email protected].
References
1. Chlebowski R et al. JAMA. 2010 Oct 20;304(15):1684-92.
2. Sinno AK et al. Gynecol Oncol. 2020;157(2):303-6.
3. Barakat et al. J Clin Oncol. 2006;24(4):587-92.
4. Hu Jun et al. J Obstet Gynaecol. 2017 Nov;37(8):1065-9.
5. Eeles R et al. J Clin Oncol. 2015 Dec 10;33(35):4138-44.
6. Chlebowski R et al. JAMA Jul 28 2020;324(4):369-80.
The impact of a gynecologic cancer diagnosis reaches beyond the obvious side effects of surgery, chemotherapy, and radiation. Many of our patients experience the quality-of-life–limiting side effects of abrupt hormone withdrawal as a consequence of our treatments. Assumptions are common, by both patients and providers, that hormonal therapy is unsafe after a gynecologic cancer diagnosis and that it is associated with an increased risk for recurrence. This sentiment likely originates from the fallout of the Womens’ Health Initiative (WHI) studies which showed an increased risk of breast cancer among users of combined estrogen and progesterone therapy.1 While this may be true for breast cancer risk, when initiated early, hormonal therapy is safe, even beneficial, for many patients with a history of gynecologic cancer, and can significantly improve their quality of life in addition to reducing all-cause mortality and incidence of osteoporosis, dementia, and cardiovascular disease.2
Premenopausal women undergoing surgery for endometrial cancer or preinvasive hyperplasia should be considered for ovarian preservation at the time of surgery. This strategy has been shown to be safe and not associated with an increased risk of recurrence. If oophorectomy is performed, hormonal therapy has been shown to be a safe remedy to the side effects of surgical menopause and the deleterious acceleration of bone loss and cardiovascular aging. The safety of hormone therapy for early-stage endometrial cancer has been thoroughly studied, including in a randomized controlled trial of more than 1,200 patients.3 This study showed no difference in the recurrence rate in users when compared with nonusers.
While hormone therapy is safe, from an oncologic standpoint, for women with a history of early-stage endometrial cancer other risks must also be considered. Given the association between endometrial cancer and obesity, these patients are at higher risk for venous thromboembolic (VTE) events, more so with the addition of exogenous hormone therapy. While not an overt contraindication to hormone prescription, obese patients who are prescribed these agents should be counseled regarding their risks for VTE.
The subgroup of patients with endometrial cancer in whom hormones should not be prescribed are those with advanced or recurrent disease. It is common for these tumors to express estrogen receptors, as evidenced by the responsiveness of these tumors to progesterone and antiestrogen treatments. Therefore, there is a theoretical risk for progression while using estrogen. In addition, as stated above, the risk of VTE is particularly elevated for women with metastatic malignancy receiving systemic therapies.
Cervical cancer commonly affects women of premenopausal age; therefore, early ovarian failure is particularly deleterious for this group of patients. Early-stage cervical cancer is most commonly treated with radical or extrafascial hysterectomy. Oophorectomy is not obligatory for the majority of these cases, and can be omitted in pre-, or perimenopausal patients to prevent surgical menopause. Ovarian metastases have been reported in cases of cervical adenocarcinoma, which led to the concern that ovarian preservation was not safe for this histology. However, recent data dispute this concern. A contemporary retrospective series of 105 patients with cervical adenocarcinoma identified no significant difference in overall survival when comparing those who had undergone ovarian preservation versus bilateral salpingo-oophorectomy.4
Ovarian preservation during cervical cancer surgery may not be enough to prevent early menopause. Approximately 20% of cervical cancer patients may require postoperative radiation for high- or intermediate-risk disease (such as positive lymph nodes, or adverse features in the tumor). For these women, ovarian ablation results, even if the ovaries were preserved at the time of surgery. Transposition of the ovaries to a location outside of the potential radiation fields is a strategy to mitigate this risk. To achieve this, the preserved ovaries and their vascular pedicles are skeletonized. The ovaries are then sutured to the paracolic gutter peritoneum or similar location above the pelvic brim, taking care to ensure that the vascular pedicle is not compromised or twisted. Placement of radio-opaque surgical clips on the caudad aspect of the transposed ovary aids in their identification by radiation oncologists when planning their treatment fields.
Ovarian transposition is most commonly used for women who are undergoing definitive surgery for cervical cancer. However, this strategy can also be used as a lead-in procedure for young women with advanced cervical cancer in whom definitive chemoradiation is planned. If the ovaries cannot be spared or moved out of “harm’s way” for premenopausal women undergoing treatment with definitive radiation, hormone therapy may be necessary and is safe for patients with cervical cancer, including those with adenocarcinoma. If the patient has not undergone hysterectomy, a regimen that includes a combination of estrogen and progesterone is necessary to avoid carcinogenic effects of unopposed estrogen on an intact endometrium, even after radiation has ablated those tissues.
When ovarian and fallopian cancers arise in premenopausal patients and appear confined to a single adnexa, contralateral ovarian preservation can be considered. However, for advanced disease, this is usually not possible or appropriate. Given that most ovarian cancers arise in a postmenopausal population, these patients may be preexisting users of hormone therapy. The data, including a randomized controlled trial, would suggest that it is safe to continue to use hormone therapy during or following a diagnosis of ovarian, fallopian tube, or primary peritoneal cancer and that it is not associated with worse outcomes from their cancer.5
Once again, patients should be carefully counseled about the additive risks for VTE that come from metastatic ovarian cancer, surgery via laparotomy, and exogenous hormonal therapy. However, these patients need not be subjected to an abrupt transition to menopause, because level I evidence suggests that these therapies are not associated with worse oncologic outcomes. All patients with ovarian, fallopian tube, and primary peritoneal cancer should receive genetic testing, and if deleterious mutations are found in BRCA 1 or 2 genes indicating an elevated risk for breast cancer, decision making regarding continued exogenous hormonal therapy is complicated. The most contemporary data, including long-term follow-up from the Women’s Health Initiative clinical trials, do not suggest an increased risk for breast cancer with estrogen-only preparations of hormone therapy.6 Given that most women with gynecologic cancers have undergone hysterectomy as part of their treatment, these estrogen-only preparations are appropriate for most.
For patients with rare tumors, such as endometrial stromal tumors or uterine leiomyosarcoma, the safety of exogenous hormone therapy should be dictated by the receptor profile of their particular cancer. Many of these cancers express estrogen receptors; therefore, current guidelines recommend against the use of hormones after these diagnoses when estrogen receptors are expressed.
Gynecologic cancer treatments induce many toxicities with long-term deleterious effects on quality of life. Use of hormones to mitigate the symptoms of menopause is an important tool in the toolkit for gynecologists. Assumptions should not be made that hormonal therapies are always unsafe for all of these patients. It is important to closely evaluate the patient’s tumor and other risk factors before withholding potentially valuable therapies.
Dr. Rossi is assistant professor in the division of gynecologic oncology at the University of North Carolina at Chapel Hill. She has no relevant financial disclosures. Email her at [email protected].
References
1. Chlebowski R et al. JAMA. 2010 Oct 20;304(15):1684-92.
2. Sinno AK et al. Gynecol Oncol. 2020;157(2):303-6.
3. Barakat et al. J Clin Oncol. 2006;24(4):587-92.
4. Hu Jun et al. J Obstet Gynaecol. 2017 Nov;37(8):1065-9.
5. Eeles R et al. J Clin Oncol. 2015 Dec 10;33(35):4138-44.
6. Chlebowski R et al. JAMA Jul 28 2020;324(4):369-80.
The impact of a gynecologic cancer diagnosis reaches beyond the obvious side effects of surgery, chemotherapy, and radiation. Many of our patients experience the quality-of-life–limiting side effects of abrupt hormone withdrawal as a consequence of our treatments. Assumptions are common, by both patients and providers, that hormonal therapy is unsafe after a gynecologic cancer diagnosis and that it is associated with an increased risk for recurrence. This sentiment likely originates from the fallout of the Womens’ Health Initiative (WHI) studies which showed an increased risk of breast cancer among users of combined estrogen and progesterone therapy.1 While this may be true for breast cancer risk, when initiated early, hormonal therapy is safe, even beneficial, for many patients with a history of gynecologic cancer, and can significantly improve their quality of life in addition to reducing all-cause mortality and incidence of osteoporosis, dementia, and cardiovascular disease.2
Premenopausal women undergoing surgery for endometrial cancer or preinvasive hyperplasia should be considered for ovarian preservation at the time of surgery. This strategy has been shown to be safe and not associated with an increased risk of recurrence. If oophorectomy is performed, hormonal therapy has been shown to be a safe remedy to the side effects of surgical menopause and the deleterious acceleration of bone loss and cardiovascular aging. The safety of hormone therapy for early-stage endometrial cancer has been thoroughly studied, including in a randomized controlled trial of more than 1,200 patients.3 This study showed no difference in the recurrence rate in users when compared with nonusers.
While hormone therapy is safe, from an oncologic standpoint, for women with a history of early-stage endometrial cancer other risks must also be considered. Given the association between endometrial cancer and obesity, these patients are at higher risk for venous thromboembolic (VTE) events, more so with the addition of exogenous hormone therapy. While not an overt contraindication to hormone prescription, obese patients who are prescribed these agents should be counseled regarding their risks for VTE.
The subgroup of patients with endometrial cancer in whom hormones should not be prescribed are those with advanced or recurrent disease. It is common for these tumors to express estrogen receptors, as evidenced by the responsiveness of these tumors to progesterone and antiestrogen treatments. Therefore, there is a theoretical risk for progression while using estrogen. In addition, as stated above, the risk of VTE is particularly elevated for women with metastatic malignancy receiving systemic therapies.
Cervical cancer commonly affects women of premenopausal age; therefore, early ovarian failure is particularly deleterious for this group of patients. Early-stage cervical cancer is most commonly treated with radical or extrafascial hysterectomy. Oophorectomy is not obligatory for the majority of these cases, and can be omitted in pre-, or perimenopausal patients to prevent surgical menopause. Ovarian metastases have been reported in cases of cervical adenocarcinoma, which led to the concern that ovarian preservation was not safe for this histology. However, recent data dispute this concern. A contemporary retrospective series of 105 patients with cervical adenocarcinoma identified no significant difference in overall survival when comparing those who had undergone ovarian preservation versus bilateral salpingo-oophorectomy.4
Ovarian preservation during cervical cancer surgery may not be enough to prevent early menopause. Approximately 20% of cervical cancer patients may require postoperative radiation for high- or intermediate-risk disease (such as positive lymph nodes, or adverse features in the tumor). For these women, ovarian ablation results, even if the ovaries were preserved at the time of surgery. Transposition of the ovaries to a location outside of the potential radiation fields is a strategy to mitigate this risk. To achieve this, the preserved ovaries and their vascular pedicles are skeletonized. The ovaries are then sutured to the paracolic gutter peritoneum or similar location above the pelvic brim, taking care to ensure that the vascular pedicle is not compromised or twisted. Placement of radio-opaque surgical clips on the caudad aspect of the transposed ovary aids in their identification by radiation oncologists when planning their treatment fields.
Ovarian transposition is most commonly used for women who are undergoing definitive surgery for cervical cancer. However, this strategy can also be used as a lead-in procedure for young women with advanced cervical cancer in whom definitive chemoradiation is planned. If the ovaries cannot be spared or moved out of “harm’s way” for premenopausal women undergoing treatment with definitive radiation, hormone therapy may be necessary and is safe for patients with cervical cancer, including those with adenocarcinoma. If the patient has not undergone hysterectomy, a regimen that includes a combination of estrogen and progesterone is necessary to avoid carcinogenic effects of unopposed estrogen on an intact endometrium, even after radiation has ablated those tissues.
When ovarian and fallopian cancers arise in premenopausal patients and appear confined to a single adnexa, contralateral ovarian preservation can be considered. However, for advanced disease, this is usually not possible or appropriate. Given that most ovarian cancers arise in a postmenopausal population, these patients may be preexisting users of hormone therapy. The data, including a randomized controlled trial, would suggest that it is safe to continue to use hormone therapy during or following a diagnosis of ovarian, fallopian tube, or primary peritoneal cancer and that it is not associated with worse outcomes from their cancer.5
Once again, patients should be carefully counseled about the additive risks for VTE that come from metastatic ovarian cancer, surgery via laparotomy, and exogenous hormonal therapy. However, these patients need not be subjected to an abrupt transition to menopause, because level I evidence suggests that these therapies are not associated with worse oncologic outcomes. All patients with ovarian, fallopian tube, and primary peritoneal cancer should receive genetic testing, and if deleterious mutations are found in BRCA 1 or 2 genes indicating an elevated risk for breast cancer, decision making regarding continued exogenous hormonal therapy is complicated. The most contemporary data, including long-term follow-up from the Women’s Health Initiative clinical trials, do not suggest an increased risk for breast cancer with estrogen-only preparations of hormone therapy.6 Given that most women with gynecologic cancers have undergone hysterectomy as part of their treatment, these estrogen-only preparations are appropriate for most.
For patients with rare tumors, such as endometrial stromal tumors or uterine leiomyosarcoma, the safety of exogenous hormone therapy should be dictated by the receptor profile of their particular cancer. Many of these cancers express estrogen receptors; therefore, current guidelines recommend against the use of hormones after these diagnoses when estrogen receptors are expressed.
Gynecologic cancer treatments induce many toxicities with long-term deleterious effects on quality of life. Use of hormones to mitigate the symptoms of menopause is an important tool in the toolkit for gynecologists. Assumptions should not be made that hormonal therapies are always unsafe for all of these patients. It is important to closely evaluate the patient’s tumor and other risk factors before withholding potentially valuable therapies.
Dr. Rossi is assistant professor in the division of gynecologic oncology at the University of North Carolina at Chapel Hill. She has no relevant financial disclosures. Email her at [email protected].
References
1. Chlebowski R et al. JAMA. 2010 Oct 20;304(15):1684-92.
2. Sinno AK et al. Gynecol Oncol. 2020;157(2):303-6.
3. Barakat et al. J Clin Oncol. 2006;24(4):587-92.
4. Hu Jun et al. J Obstet Gynaecol. 2017 Nov;37(8):1065-9.
5. Eeles R et al. J Clin Oncol. 2015 Dec 10;33(35):4138-44.
6. Chlebowski R et al. JAMA Jul 28 2020;324(4):369-80.
Fetuses suffer the effects of poverty in the womb
Poverty is known to be associated with poor health outcomes throughout life. Now, new research has shown that, from as early as the second trimester of pregnancy, fetuses are already feeling the effects of poverty.
“There is a well-recognized health inequality where quality and duration of life are lower among the most poor. This divide is present both within and between countries,” said Steve Turner, who led the study.
Given the association of poverty and low birth weight, the authors of the new multi-national study, published in the Journal of Epidemiology and Community Health, hypothesized that “individuals from highest household income compared to those with lowest household income will have increased fetal size in the second and third trimester and birth.”
For their study, researchers from the University of Aberdeen gathered details of ante-natal and birth size – second and third trimester fetal ultrasound measurements of estimated fetal weight, biparietal diameter, and femur length, as well as birth measurements of weight, occipitofrontal circumference, and crown heel length – from eight cohorts that included 21,714 individuals from nations including Scotland, England, Saudi Arabia, the U.S., Netherlands, Spain, Norway, Sweden, and France.
They then related these to household income, taking into account other factors, including mother’s age, height, number of other children, and smoking, analyzing the data using cross-sectional two-stage individual patient data analyses and a longitudinal one-stage individual patient data analysis.
Household income closely related to birth size
The authors found that higher household income was associated with larger fetal head size and weight but not length, from the second half of pregnancy, compared with lowest household income. They said that their results argue for “a relationship where household income is closely related to birth size.”
The results showed that, across the countries studied, babies were smaller at birth if they came from a lower income household, and this discrepancy in size was already apparent at 20 weeks gestation.
“This is the first time that size differences have been found at such an early stage of development,” the authors said, “and also the first time it has been compared across continents.”
Professor Turner pointed out that “what this study shows is that the inequality, as seen by reduced size in fetal life, is present long before birth, and this poverty gap widens between twenty weeks gestation and birth.”
He added: “Basically, regardless of whether you live in Saudi, the U.S., or Europe, and accounting for things that might affect fetal growth, if your parents are poor, you will be smaller before birth and at birth compared to if your parents were not poor.”
Increase engagement with pregnant mothers living in poverty
He emphasized how this was problematic, as small size before and after birth puts an individual at “increased risk for many serious illnesses in later life.”
The authors hope that this study will encourage health care providers to recognize the health risks associated with lower income for mothers and their unborn children and to provide more support and guidance to mitigate the risks.
They said, “interventions aimed at softening the impact of poverty on pregnant mothers could reduce incidence of small for gestational age and the associated burden of excessive morbidity and mortality throughout the life course.”
Professor Turner described how the mechanisms that drive this inequity may be explained by pregnant mothers from poor households having difficulty in accessing or engaging with antenatal care.
“We would like to see health care providers around the world strive to increase engagement with pregnant mothers living in poverty,” he said. “This engagement will reward all of society by putting unborn children on a trajectory to longer and healthier lives.”
A version of this article first appeared on Medscape UK.
Poverty is known to be associated with poor health outcomes throughout life. Now, new research has shown that, from as early as the second trimester of pregnancy, fetuses are already feeling the effects of poverty.
“There is a well-recognized health inequality where quality and duration of life are lower among the most poor. This divide is present both within and between countries,” said Steve Turner, who led the study.
Given the association of poverty and low birth weight, the authors of the new multi-national study, published in the Journal of Epidemiology and Community Health, hypothesized that “individuals from highest household income compared to those with lowest household income will have increased fetal size in the second and third trimester and birth.”
For their study, researchers from the University of Aberdeen gathered details of ante-natal and birth size – second and third trimester fetal ultrasound measurements of estimated fetal weight, biparietal diameter, and femur length, as well as birth measurements of weight, occipitofrontal circumference, and crown heel length – from eight cohorts that included 21,714 individuals from nations including Scotland, England, Saudi Arabia, the U.S., Netherlands, Spain, Norway, Sweden, and France.
They then related these to household income, taking into account other factors, including mother’s age, height, number of other children, and smoking, analyzing the data using cross-sectional two-stage individual patient data analyses and a longitudinal one-stage individual patient data analysis.
Household income closely related to birth size
The authors found that higher household income was associated with larger fetal head size and weight but not length, from the second half of pregnancy, compared with lowest household income. They said that their results argue for “a relationship where household income is closely related to birth size.”
The results showed that, across the countries studied, babies were smaller at birth if they came from a lower income household, and this discrepancy in size was already apparent at 20 weeks gestation.
“This is the first time that size differences have been found at such an early stage of development,” the authors said, “and also the first time it has been compared across continents.”
Professor Turner pointed out that “what this study shows is that the inequality, as seen by reduced size in fetal life, is present long before birth, and this poverty gap widens between twenty weeks gestation and birth.”
He added: “Basically, regardless of whether you live in Saudi, the U.S., or Europe, and accounting for things that might affect fetal growth, if your parents are poor, you will be smaller before birth and at birth compared to if your parents were not poor.”
Increase engagement with pregnant mothers living in poverty
He emphasized how this was problematic, as small size before and after birth puts an individual at “increased risk for many serious illnesses in later life.”
The authors hope that this study will encourage health care providers to recognize the health risks associated with lower income for mothers and their unborn children and to provide more support and guidance to mitigate the risks.
They said, “interventions aimed at softening the impact of poverty on pregnant mothers could reduce incidence of small for gestational age and the associated burden of excessive morbidity and mortality throughout the life course.”
Professor Turner described how the mechanisms that drive this inequity may be explained by pregnant mothers from poor households having difficulty in accessing or engaging with antenatal care.
“We would like to see health care providers around the world strive to increase engagement with pregnant mothers living in poverty,” he said. “This engagement will reward all of society by putting unborn children on a trajectory to longer and healthier lives.”
A version of this article first appeared on Medscape UK.
Poverty is known to be associated with poor health outcomes throughout life. Now, new research has shown that, from as early as the second trimester of pregnancy, fetuses are already feeling the effects of poverty.
“There is a well-recognized health inequality where quality and duration of life are lower among the most poor. This divide is present both within and between countries,” said Steve Turner, who led the study.
Given the association of poverty and low birth weight, the authors of the new multi-national study, published in the Journal of Epidemiology and Community Health, hypothesized that “individuals from highest household income compared to those with lowest household income will have increased fetal size in the second and third trimester and birth.”
For their study, researchers from the University of Aberdeen gathered details of ante-natal and birth size – second and third trimester fetal ultrasound measurements of estimated fetal weight, biparietal diameter, and femur length, as well as birth measurements of weight, occipitofrontal circumference, and crown heel length – from eight cohorts that included 21,714 individuals from nations including Scotland, England, Saudi Arabia, the U.S., Netherlands, Spain, Norway, Sweden, and France.
They then related these to household income, taking into account other factors, including mother’s age, height, number of other children, and smoking, analyzing the data using cross-sectional two-stage individual patient data analyses and a longitudinal one-stage individual patient data analysis.
Household income closely related to birth size
The authors found that higher household income was associated with larger fetal head size and weight but not length, from the second half of pregnancy, compared with lowest household income. They said that their results argue for “a relationship where household income is closely related to birth size.”
The results showed that, across the countries studied, babies were smaller at birth if they came from a lower income household, and this discrepancy in size was already apparent at 20 weeks gestation.
“This is the first time that size differences have been found at such an early stage of development,” the authors said, “and also the first time it has been compared across continents.”
Professor Turner pointed out that “what this study shows is that the inequality, as seen by reduced size in fetal life, is present long before birth, and this poverty gap widens between twenty weeks gestation and birth.”
He added: “Basically, regardless of whether you live in Saudi, the U.S., or Europe, and accounting for things that might affect fetal growth, if your parents are poor, you will be smaller before birth and at birth compared to if your parents were not poor.”
Increase engagement with pregnant mothers living in poverty
He emphasized how this was problematic, as small size before and after birth puts an individual at “increased risk for many serious illnesses in later life.”
The authors hope that this study will encourage health care providers to recognize the health risks associated with lower income for mothers and their unborn children and to provide more support and guidance to mitigate the risks.
They said, “interventions aimed at softening the impact of poverty on pregnant mothers could reduce incidence of small for gestational age and the associated burden of excessive morbidity and mortality throughout the life course.”
Professor Turner described how the mechanisms that drive this inequity may be explained by pregnant mothers from poor households having difficulty in accessing or engaging with antenatal care.
“We would like to see health care providers around the world strive to increase engagement with pregnant mothers living in poverty,” he said. “This engagement will reward all of society by putting unborn children on a trajectory to longer and healthier lives.”
A version of this article first appeared on Medscape UK.
FROM THE JOURNAL OF EPIDEMIOLOGY AND COMMUNITY HEALTH
Emerging tick-borne pathogen has spread to state of Georgia
Heartland virus (HRTV), an emerging infection first detected in lone star ticks in Missouri in 2009, has spread to lone star ticks in Georgia, a study published in Emerging Infectious Diseases reports.
HRTV disease is transmitted by the bite of an infected Amblyomma americanum tick, named “lone star” because of the silver-white spot on the female scutum (back).
“By … sampling … in an area with reported exposure to HRTV in wildlife and humans and testing for infection in thousands of ticks from multiple sites and physiologic stages, we confirmed the presence of HRTV in Georgia,” the authors write.
“This information about the expanding geographic range of lone star ticks, combined with increased human presence in tick-infested habitats, can be used to improve strategies for preventing tick bites and to alert physicians about this emerging tickborne virus infection,” a press release by the Centers for Disease Control and Prevention notes.
Persistent field and lab work led to HRTV discovery in Georgia
The search for infected lone star ticks began after a retroactive analysis confirmed that a person who died in Georgia in 2005 from an unidentified illness was infected with HRTV. A subsequent analysis of serum samples collected earlier from local white-tailed deer showed that the deer had been exposed to HRTV since at least 2001, according to a press release by Emory University.
These discoveries prompted local researchers to investigate whether lone star ticks in rural, woodsy central Georgia were carrying HRTV.
Lead study author Yamila Romer, MD, an infectious disease clinician and microbiologist in the department of environmental sciences at Emory University in Atlanta, and her colleagues collected samples of ticks in 2018 at 26 sites near the location of the patient who died and the seropositive deer. In 2019, they focused their collections on the two sites that had provided the most ticks in 2018.
From April to October in both years, the research team visited sites weekly to swish white flannel flags through underbrush. They picked off adult and nymph Amblyomma americanum ticks, placed them into vials, and transported them to their lab. They sorted 9,294 ticks by sex, life stage, and collection site. Then they crushed the ticks and extracted their RNA.
To confirm viral infection, the team tested RNA extracted from cell culture supernatants using a real-time polymerase chain reaction test specific for HRTV.
In the three pools of ticks that tested positive for HRTV, the researchers found a minimum infection rate of 0.46/1,000 ticks, suggesting that about 1 of every 2,000 ticks carried HRTV. They sequenced the genome of the three isolates and found that the genomes were similar to one another but were very different from the genomes from HRTV samples taken outside Georgia.
Catherine A. Hill, PhD, a professor of entomology and vector biology and the interim head of the department of entomology at Purdue University in West Lafayette, Ind., was impressed with the researchers’ discovery.
“Heartland virus is difficult to detect,” she said in an email. “The prevalence of human cases is low, and the virus appears to be present at very low levels in populations of lone star tick. The investigators went to some lengths to survey for the virus, collect, and process thousands of ticks – and they found the needle in the haystack.” Dr. Hill was not involved in the study.
Georgia data help researchers monitor HRTV spread
HRTV was first identified in 2009 in Missouri in two people hospitalized with fever, muscle pain, diarrhea, and low white blood cell and platelet counts. Researchers traced the infections to lone star ticks, and they found antibodies to the virus in blood samples from deer and other wild mammals.
According to the CDC, U.S. cases of tick-borne diseases more than doubled between 2004 and 2016. As of January 2021, more than 50 human cases of HRTV disease had been reported in 11 Midwestern and Southeastern states: Arkansas, Georgia, Illinois, Indiana, Iowa, Kansas, Kentucky, Missouri, North Carolina, Oklahoma, and Tennessee.
Precautions, signs, symptoms, testing, and treatment
“The lone star tick is aggressive and will actively seek out a human host to bite,” Dr. Hill noted.
She recommends that health care providers advise patients to avoid tick habitat, wear protective clothing, apply repellants, know the signs and symptoms of tick-borne disease, and seek immediate medical care if they become ill.
Common symptoms of HRTV disease include fatigue, fever, nausea, diarrhea, and anorexia. Treatment is supportive. Many patients have been hospitalized, and some with comorbidities have died.
HRTV infection is rarely tested for, and the disease burden is unknown. With no commercial tests available in the United States, the CDC performs molecular and serologic testing for HRTV infection. The agency advises doctors to contact their state health department if they suspect a patient may have HRTV disease.
Further research is needed
Samantha M. Wisely, PhD, a professor of wildlife ecology and the director of the Cervidae Health Research Initiative at the University of Florida in Gainesville, was not surprised by the study finding.
“The more we look for heartland virus, the more places we find it,” Dr. Wisely told this news organization in an email.
“Little is known about which wildlife play a role in maintaining the virus on the landscape,” said Dr. Wisely, who was not involved in the study. “White-tailed deer have been shown to produce antibodies, meaning they have been exposed to the virus, but no one has actually found the virus in a wildlife species.”
The whole-genome sequencing of the virus was particularly important, Dr. Wisely explained. “Whole-genome data allow researchers to better understand viral evolution, pathogenicity, and viral dynamics across space and time – how it is evolving.”
The study was supported by a grant from the Emory University Research Council. The authors, Dr. Wisely, and Dr. Hill have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Heartland virus (HRTV), an emerging infection first detected in lone star ticks in Missouri in 2009, has spread to lone star ticks in Georgia, a study published in Emerging Infectious Diseases reports.
HRTV disease is transmitted by the bite of an infected Amblyomma americanum tick, named “lone star” because of the silver-white spot on the female scutum (back).
“By … sampling … in an area with reported exposure to HRTV in wildlife and humans and testing for infection in thousands of ticks from multiple sites and physiologic stages, we confirmed the presence of HRTV in Georgia,” the authors write.
“This information about the expanding geographic range of lone star ticks, combined with increased human presence in tick-infested habitats, can be used to improve strategies for preventing tick bites and to alert physicians about this emerging tickborne virus infection,” a press release by the Centers for Disease Control and Prevention notes.
Persistent field and lab work led to HRTV discovery in Georgia
The search for infected lone star ticks began after a retroactive analysis confirmed that a person who died in Georgia in 2005 from an unidentified illness was infected with HRTV. A subsequent analysis of serum samples collected earlier from local white-tailed deer showed that the deer had been exposed to HRTV since at least 2001, according to a press release by Emory University.
These discoveries prompted local researchers to investigate whether lone star ticks in rural, woodsy central Georgia were carrying HRTV.
Lead study author Yamila Romer, MD, an infectious disease clinician and microbiologist in the department of environmental sciences at Emory University in Atlanta, and her colleagues collected samples of ticks in 2018 at 26 sites near the location of the patient who died and the seropositive deer. In 2019, they focused their collections on the two sites that had provided the most ticks in 2018.
From April to October in both years, the research team visited sites weekly to swish white flannel flags through underbrush. They picked off adult and nymph Amblyomma americanum ticks, placed them into vials, and transported them to their lab. They sorted 9,294 ticks by sex, life stage, and collection site. Then they crushed the ticks and extracted their RNA.
To confirm viral infection, the team tested RNA extracted from cell culture supernatants using a real-time polymerase chain reaction test specific for HRTV.
In the three pools of ticks that tested positive for HRTV, the researchers found a minimum infection rate of 0.46/1,000 ticks, suggesting that about 1 of every 2,000 ticks carried HRTV. They sequenced the genome of the three isolates and found that the genomes were similar to one another but were very different from the genomes from HRTV samples taken outside Georgia.
Catherine A. Hill, PhD, a professor of entomology and vector biology and the interim head of the department of entomology at Purdue University in West Lafayette, Ind., was impressed with the researchers’ discovery.
“Heartland virus is difficult to detect,” she said in an email. “The prevalence of human cases is low, and the virus appears to be present at very low levels in populations of lone star tick. The investigators went to some lengths to survey for the virus, collect, and process thousands of ticks – and they found the needle in the haystack.” Dr. Hill was not involved in the study.
Georgia data help researchers monitor HRTV spread
HRTV was first identified in 2009 in Missouri in two people hospitalized with fever, muscle pain, diarrhea, and low white blood cell and platelet counts. Researchers traced the infections to lone star ticks, and they found antibodies to the virus in blood samples from deer and other wild mammals.
According to the CDC, U.S. cases of tick-borne diseases more than doubled between 2004 and 2016. As of January 2021, more than 50 human cases of HRTV disease had been reported in 11 Midwestern and Southeastern states: Arkansas, Georgia, Illinois, Indiana, Iowa, Kansas, Kentucky, Missouri, North Carolina, Oklahoma, and Tennessee.
Precautions, signs, symptoms, testing, and treatment
“The lone star tick is aggressive and will actively seek out a human host to bite,” Dr. Hill noted.
She recommends that health care providers advise patients to avoid tick habitat, wear protective clothing, apply repellants, know the signs and symptoms of tick-borne disease, and seek immediate medical care if they become ill.
Common symptoms of HRTV disease include fatigue, fever, nausea, diarrhea, and anorexia. Treatment is supportive. Many patients have been hospitalized, and some with comorbidities have died.
HRTV infection is rarely tested for, and the disease burden is unknown. With no commercial tests available in the United States, the CDC performs molecular and serologic testing for HRTV infection. The agency advises doctors to contact their state health department if they suspect a patient may have HRTV disease.
Further research is needed
Samantha M. Wisely, PhD, a professor of wildlife ecology and the director of the Cervidae Health Research Initiative at the University of Florida in Gainesville, was not surprised by the study finding.
“The more we look for heartland virus, the more places we find it,” Dr. Wisely told this news organization in an email.
“Little is known about which wildlife play a role in maintaining the virus on the landscape,” said Dr. Wisely, who was not involved in the study. “White-tailed deer have been shown to produce antibodies, meaning they have been exposed to the virus, but no one has actually found the virus in a wildlife species.”
The whole-genome sequencing of the virus was particularly important, Dr. Wisely explained. “Whole-genome data allow researchers to better understand viral evolution, pathogenicity, and viral dynamics across space and time – how it is evolving.”
The study was supported by a grant from the Emory University Research Council. The authors, Dr. Wisely, and Dr. Hill have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Heartland virus (HRTV), an emerging infection first detected in lone star ticks in Missouri in 2009, has spread to lone star ticks in Georgia, a study published in Emerging Infectious Diseases reports.
HRTV disease is transmitted by the bite of an infected Amblyomma americanum tick, named “lone star” because of the silver-white spot on the female scutum (back).
“By … sampling … in an area with reported exposure to HRTV in wildlife and humans and testing for infection in thousands of ticks from multiple sites and physiologic stages, we confirmed the presence of HRTV in Georgia,” the authors write.
“This information about the expanding geographic range of lone star ticks, combined with increased human presence in tick-infested habitats, can be used to improve strategies for preventing tick bites and to alert physicians about this emerging tickborne virus infection,” a press release by the Centers for Disease Control and Prevention notes.
Persistent field and lab work led to HRTV discovery in Georgia
The search for infected lone star ticks began after a retroactive analysis confirmed that a person who died in Georgia in 2005 from an unidentified illness was infected with HRTV. A subsequent analysis of serum samples collected earlier from local white-tailed deer showed that the deer had been exposed to HRTV since at least 2001, according to a press release by Emory University.
These discoveries prompted local researchers to investigate whether lone star ticks in rural, woodsy central Georgia were carrying HRTV.
Lead study author Yamila Romer, MD, an infectious disease clinician and microbiologist in the department of environmental sciences at Emory University in Atlanta, and her colleagues collected samples of ticks in 2018 at 26 sites near the location of the patient who died and the seropositive deer. In 2019, they focused their collections on the two sites that had provided the most ticks in 2018.
From April to October in both years, the research team visited sites weekly to swish white flannel flags through underbrush. They picked off adult and nymph Amblyomma americanum ticks, placed them into vials, and transported them to their lab. They sorted 9,294 ticks by sex, life stage, and collection site. Then they crushed the ticks and extracted their RNA.
To confirm viral infection, the team tested RNA extracted from cell culture supernatants using a real-time polymerase chain reaction test specific for HRTV.
In the three pools of ticks that tested positive for HRTV, the researchers found a minimum infection rate of 0.46/1,000 ticks, suggesting that about 1 of every 2,000 ticks carried HRTV. They sequenced the genome of the three isolates and found that the genomes were similar to one another but were very different from the genomes from HRTV samples taken outside Georgia.
Catherine A. Hill, PhD, a professor of entomology and vector biology and the interim head of the department of entomology at Purdue University in West Lafayette, Ind., was impressed with the researchers’ discovery.
“Heartland virus is difficult to detect,” she said in an email. “The prevalence of human cases is low, and the virus appears to be present at very low levels in populations of lone star tick. The investigators went to some lengths to survey for the virus, collect, and process thousands of ticks – and they found the needle in the haystack.” Dr. Hill was not involved in the study.
Georgia data help researchers monitor HRTV spread
HRTV was first identified in 2009 in Missouri in two people hospitalized with fever, muscle pain, diarrhea, and low white blood cell and platelet counts. Researchers traced the infections to lone star ticks, and they found antibodies to the virus in blood samples from deer and other wild mammals.
According to the CDC, U.S. cases of tick-borne diseases more than doubled between 2004 and 2016. As of January 2021, more than 50 human cases of HRTV disease had been reported in 11 Midwestern and Southeastern states: Arkansas, Georgia, Illinois, Indiana, Iowa, Kansas, Kentucky, Missouri, North Carolina, Oklahoma, and Tennessee.
Precautions, signs, symptoms, testing, and treatment
“The lone star tick is aggressive and will actively seek out a human host to bite,” Dr. Hill noted.
She recommends that health care providers advise patients to avoid tick habitat, wear protective clothing, apply repellants, know the signs and symptoms of tick-borne disease, and seek immediate medical care if they become ill.
Common symptoms of HRTV disease include fatigue, fever, nausea, diarrhea, and anorexia. Treatment is supportive. Many patients have been hospitalized, and some with comorbidities have died.
HRTV infection is rarely tested for, and the disease burden is unknown. With no commercial tests available in the United States, the CDC performs molecular and serologic testing for HRTV infection. The agency advises doctors to contact their state health department if they suspect a patient may have HRTV disease.
Further research is needed
Samantha M. Wisely, PhD, a professor of wildlife ecology and the director of the Cervidae Health Research Initiative at the University of Florida in Gainesville, was not surprised by the study finding.
“The more we look for heartland virus, the more places we find it,” Dr. Wisely told this news organization in an email.
“Little is known about which wildlife play a role in maintaining the virus on the landscape,” said Dr. Wisely, who was not involved in the study. “White-tailed deer have been shown to produce antibodies, meaning they have been exposed to the virus, but no one has actually found the virus in a wildlife species.”
The whole-genome sequencing of the virus was particularly important, Dr. Wisely explained. “Whole-genome data allow researchers to better understand viral evolution, pathogenicity, and viral dynamics across space and time – how it is evolving.”
The study was supported by a grant from the Emory University Research Council. The authors, Dr. Wisely, and Dr. Hill have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM EMERGING INFECTIOUS DISEASES
Cheap and noninvasive: Detecting HPV in sanitary pads
A cell phone rings in a red-brick bungalow in a village in India. A woman on the other end of the phone tells Ms. SK, a community health worker, that menstruation has started. Ms. SK guns her scooter through the dusty streets for 15 minutes in 30° C (86° F) heat.
A 32-year-old woman, waiting in the shade of a blue corrugated-iron roof, hands over a green polythene bag. Ms. SK whisks the package to the local health center and tucks it into a –20° C freezer. The following week, it will ride in dry ice to the National Institute for Research in Reproductive and Child Health Laboratory in Mumbai for human papillomavirus (HPV) testing.
This moment in rural India at first glance appears to have little relevance to wealthy countries such as the United States.
However, public health officials in both countries are trying to solve the same problem: how to prevent unnecessary deaths from cervical cancer by reaching women who have never or rarely been screened.
The United States has more in common with India than it may care to admit.
“In the U.S., we still have pockets of disparities that actually have incidence rates [of cervical cancer] comparable to many low- and middle-income countries,” said Vikrant Sahasrabuddhe, MBBS, DrPh, MPH, of the National Cancer Institute, where he heads the HPV and cervical cancer prevention clinical research program for the National Institutes of Health.
The incidence of cervical cancer in India is approximately 19 per 100,000 women. For the past 15 years incidence in the United States has stalled at approximately 7 per 100,000.
In India, there are no organized screening programs and most cervical cancer is regional or distant metastatic at diagnosis.
In the United States, 52% of new cases are advanced, and half of these are among women who have never or rarely been screened.
“There is a critical need for new strategies to reach this population,” Dr. Sahasrabuddhe said. “We absolutely have to do something out of the box creatively.”
Almost all cervical cancers are triggered by HPV, most commonly high-risk HPV-16 and HPV-18, although there are more than 200 types. HPV testing is taking over from cytology (Papanicolaou test) for secondary prevention of cervical cancer.
The trial of screening for HPV in menstrual pads that is ongoing in India was the brainchild of Atul Budukh, PhD, a government public health researcher and professor at the Centre for Cancer Epidemiology, Tata Memorial Centre, Mumbai.
Dr. Budukh’s eyes were opened to the scale of the problem when he participated in a cluster-randomized trial funded by the Bill and Melinda Gates Foundation. The study, published in 2009 in the New England Journal of Medicine, involved 131,746 rural women in the Osmanabad district of India.
A team of researchers from India and France compared outcomes for women over 8 years after cervical screening by HPV, cytology, or visual inspection with acetic acid. The control group was usual care, where women were advised how to seek screening at local hospitals. Women who screened positive were referred for colposcopy, biopsy, and treatment.
Over the 8-year follow-up, advanced cervical cancer was found in twice as many women left to their own devices, compared with women who had HPV testing during the study (82 vs. 39; hazard ratio for HPV, 0.47; 95% confidence interval, 0.32-0.69).
Similarly, cervical cancer deaths in the control group were nearly two times higher than among the women who were screened for HPV in the study (64 vs. 34; HR for HPV, 0.52; 95% CI, 0.33-0.83).
The study proved that rural Indian women were dying unnecessarily because they weren’t seeking cervical screening. And education wasn’t the problem.
“When we go and educate [a rural woman] about ... risk factors and the need to undergo screening, she understands it very well,” said Dr. Budukh. “She is ready to come but her priority is her bread and butter – she will lose her daily wages.”
Dr. Budukh and his team negotiated with local employers so that women could come to screening clinics, but they soon realized this wasn’t scalable.
One year after the NEJM publication, Dr. Budukh found what he was looking for.
A team of Hong Kong clinicians, headed by Sze Chuen Cesar Wong of the Hong Kong Cancer Institute, published a paper in 2010 in the Journal of Clinical Microbiology showing that menstrual pads provide reliable HPV results in women with and without cervical disease.
The Hong Kong team tested sanitary napkins for HPV from 235 of their patients with cervical intraepithelial neoplasia or condyloma acuminatum before and after treatment. Samples were compared with those from 323 women without cervical disease; for HPV in sanitary napkins the sensitivity was 82.8%, specificity was 93.1%, and positive and negative predictive values were 90% and 87.9%, respectively.
The authors pointed out that menstrual pad testing was the only truly noninvasive approach to HPV screening versus the other self-sampling methods such as tampons and cytobrushes. Also, these self-sampling tests require specialized liquid-based transport media. A menstrual pad needs only a plastic bag.
Dr. Budukh had his at-home solution for the hard-working rural women of India.
With funding from the Indian government, Dr. Budukh’s team put together a validation trial that ran from 2013 to 2016 in 18 rural villages in two separate districts: Ahmednagar and Pune.
Local health workers went house to house to recruit women and get family buy-in for this culturally delicate project. Participants were instructed to use their regular sanitary protection – most commonly a washable cloth – and told to call the health worker on the first day of menstruation. Health workers gave each woman a Ziploc bag for the pad and, for privacy, an outer polythene sac.
In Ahmednagar, all women who provided their pad also got screened with Hybrid Capture 2 (HC2; Qiagen) by a mobile screening unit. In Pune, only the positive cases underwent HC2. Screening was also extended to anyone who requested it, but these people were not included in the final analysis.
Genomic DNA was extracted from three 5 mm–sized punches in the pad using a commercial kit, QIAamp DNA Micro, and the quality and purity of the DNA checked by Implen NanoPhotometer.
The team followed the same protocol for PCR HPV assay as the team from Hong Kong.
The results were published in the European Journal of Cancer Prevention in 2018.
The concordance rate for a positive result between the menstrual pad sample and conventional HPV sampling was 98.8% for Ahmednagar and 95.2% for samples from Pune. The sensitivity for the first study was 83% and the specificity 99% – similar to that for the women in Hong Kong. The second study had lower sensitivity and specificity (67% and 88%), partly because of poor storage as a result of frequent power cuts.
The total cost per woman was $30.78.
“I was very excited when we saw the results,” Dr. Budukh recalled. “That day I couldn’t sleep ... such a wonderful result! I was excited to start the next phase immediately.”
Dr. Budukh has applied to the Indian government for funding for a larger trial involving 3,000 women. If successful, he hopes such evidence would be sufficient to convince the Indian government to make menstrual pad screening standard procedure for the 390 million women who live in India’s countryside.
Testing never-screened women for cervical cancer using menstrual pads appears to be relatively reliable, convenient, private, noninvasive, and incredibly cheap.
So who else has tried it?
The first published account of HPV in menstrual blood was a 2003 study by Tommy Tong and colleagues at the Princess Margaret Hospital in Hong Kong. The authors heralded, with lamentable optimism, “a new paradigm in cervical cancer screening.”
In the following 20 years, just six more studies appeared: two from Dr. Budukh’s field trial in India and four from hospital-based pilot studies in Hong Kong (in 2010 and 2018), South Korea (in 2016), and mainland China (in 2021). All these studies, although small, were published in top-flight journals and demonstrate high concordance between conventional high-risk HPV testing and menstrual-blood tests.
This news organization tried to find a U.S. thought-leader who had heard of the approach.
Elizabeth Fontham, MPH, DrPh, is the founding dean of the school of public health at Louisiana State University Health Center in New Orleans, and president of the American Cancer Society. Dr. Fontham said in an email that she had “no plans to evaluate the impact related to menstrual pads, but perhaps others have looked into that.”
Joy Melnikow, MD, MPH, was first author on the evidence synthesis driving the current cervical cancer screening recommendations from the U.S. Preventive Services Task Force. When asked about menstrual pad testing for HPV, she said she had “not heard of it before.”
The USPSTF guidelines don’t mention sanitary pads but acknowledge that “self-collection may be one strategy for increasing screening rates among populations where they are currently low.”
The USPSTF methodology excludes data from countries that don’t match the United States on the Human Development Index “or [are] not applicable to U.S. clinical settings or populations.” (Presumably, data from Hong Kong and South Korea would qualify; Indian data would not.)
Dr. Sahasrabuddhe of the NCI hadn’t heard of menstrual pad testing either, but he has a different explanation for lack of interest in this approach – or, indeed, any form of self-sampling for cervical cancer screening – in the United States.
“We have not seen movement happen in this space for years. ... If there is one intervention that we can simplify, that still has not been made widely available, it is self-sampling ... [but] we don’t have [Food and Drug Administration] approval for it,” Dr. Sahasrabuddhe said.
“Our system, at least in the U.S., is based on industry manufacturers seeking an approval for a particular way of collection and then clinicians and clinical-guideline bodies signing on. ... For a lot of reasons industry has shied away over the past several years, so far, at least, on seeking approval for self-sampling-based approaches,” he commented.
Dr. Sahasrabuddhe aims to change that. He heads a new NCI-led initiative called “The Last Mile,” a nationwide clinical trial supported by federal agencies, industry partners, and professional societies. The goal is to validate self-sampled HPV testing as non-inferior to specimens collected by providers. The team is currently finalizing the methodology of the study, so Dr. Sahasrabuddhe could not share the self-sampling methods that will be on trial, nor the industry partners who have signed up.
The following tests are approved in the United States for physician-collected HPV screening: Hybrid Capture 2, used in the Indian studies (Qiagen); cobas HPV (Roche); Aptima (Hologic); Cervista (Hologic); and Onclarity (Becton Dickinson).
Dr. Sahasrabuddhe said that, while a sanitary pad in a Ziploc bag is unlikely to make the grade for The Last Mile study, he doesn’t totally dismiss their potential and said the NCI is always open to new ideas.
“We are not supporting anybody specifically for menstrual pad-based collection device development,” Dr. Sahasrabuddhe said, “But if they fulfill other criteria for a small business–based grant application, they absolutely are welcome to apply for NCI funding for this.”
Said Dr. Melnikow: “Pre-COVID, the head of [the World Health Organization] said that we could eliminate cervical cancer from the globe and that we have the tools to do that now. And he’s right.”
Dr. Budukh, Dr. Melnikow, and Dr. Sahasrabuddhe disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
A cell phone rings in a red-brick bungalow in a village in India. A woman on the other end of the phone tells Ms. SK, a community health worker, that menstruation has started. Ms. SK guns her scooter through the dusty streets for 15 minutes in 30° C (86° F) heat.
A 32-year-old woman, waiting in the shade of a blue corrugated-iron roof, hands over a green polythene bag. Ms. SK whisks the package to the local health center and tucks it into a –20° C freezer. The following week, it will ride in dry ice to the National Institute for Research in Reproductive and Child Health Laboratory in Mumbai for human papillomavirus (HPV) testing.
This moment in rural India at first glance appears to have little relevance to wealthy countries such as the United States.
However, public health officials in both countries are trying to solve the same problem: how to prevent unnecessary deaths from cervical cancer by reaching women who have never or rarely been screened.
The United States has more in common with India than it may care to admit.
“In the U.S., we still have pockets of disparities that actually have incidence rates [of cervical cancer] comparable to many low- and middle-income countries,” said Vikrant Sahasrabuddhe, MBBS, DrPh, MPH, of the National Cancer Institute, where he heads the HPV and cervical cancer prevention clinical research program for the National Institutes of Health.
The incidence of cervical cancer in India is approximately 19 per 100,000 women. For the past 15 years incidence in the United States has stalled at approximately 7 per 100,000.
In India, there are no organized screening programs and most cervical cancer is regional or distant metastatic at diagnosis.
In the United States, 52% of new cases are advanced, and half of these are among women who have never or rarely been screened.
“There is a critical need for new strategies to reach this population,” Dr. Sahasrabuddhe said. “We absolutely have to do something out of the box creatively.”
Almost all cervical cancers are triggered by HPV, most commonly high-risk HPV-16 and HPV-18, although there are more than 200 types. HPV testing is taking over from cytology (Papanicolaou test) for secondary prevention of cervical cancer.
The trial of screening for HPV in menstrual pads that is ongoing in India was the brainchild of Atul Budukh, PhD, a government public health researcher and professor at the Centre for Cancer Epidemiology, Tata Memorial Centre, Mumbai.
Dr. Budukh’s eyes were opened to the scale of the problem when he participated in a cluster-randomized trial funded by the Bill and Melinda Gates Foundation. The study, published in 2009 in the New England Journal of Medicine, involved 131,746 rural women in the Osmanabad district of India.
A team of researchers from India and France compared outcomes for women over 8 years after cervical screening by HPV, cytology, or visual inspection with acetic acid. The control group was usual care, where women were advised how to seek screening at local hospitals. Women who screened positive were referred for colposcopy, biopsy, and treatment.
Over the 8-year follow-up, advanced cervical cancer was found in twice as many women left to their own devices, compared with women who had HPV testing during the study (82 vs. 39; hazard ratio for HPV, 0.47; 95% confidence interval, 0.32-0.69).
Similarly, cervical cancer deaths in the control group were nearly two times higher than among the women who were screened for HPV in the study (64 vs. 34; HR for HPV, 0.52; 95% CI, 0.33-0.83).
The study proved that rural Indian women were dying unnecessarily because they weren’t seeking cervical screening. And education wasn’t the problem.
“When we go and educate [a rural woman] about ... risk factors and the need to undergo screening, she understands it very well,” said Dr. Budukh. “She is ready to come but her priority is her bread and butter – she will lose her daily wages.”
Dr. Budukh and his team negotiated with local employers so that women could come to screening clinics, but they soon realized this wasn’t scalable.
One year after the NEJM publication, Dr. Budukh found what he was looking for.
A team of Hong Kong clinicians, headed by Sze Chuen Cesar Wong of the Hong Kong Cancer Institute, published a paper in 2010 in the Journal of Clinical Microbiology showing that menstrual pads provide reliable HPV results in women with and without cervical disease.
The Hong Kong team tested sanitary napkins for HPV from 235 of their patients with cervical intraepithelial neoplasia or condyloma acuminatum before and after treatment. Samples were compared with those from 323 women without cervical disease; for HPV in sanitary napkins the sensitivity was 82.8%, specificity was 93.1%, and positive and negative predictive values were 90% and 87.9%, respectively.
The authors pointed out that menstrual pad testing was the only truly noninvasive approach to HPV screening versus the other self-sampling methods such as tampons and cytobrushes. Also, these self-sampling tests require specialized liquid-based transport media. A menstrual pad needs only a plastic bag.
Dr. Budukh had his at-home solution for the hard-working rural women of India.
With funding from the Indian government, Dr. Budukh’s team put together a validation trial that ran from 2013 to 2016 in 18 rural villages in two separate districts: Ahmednagar and Pune.
Local health workers went house to house to recruit women and get family buy-in for this culturally delicate project. Participants were instructed to use their regular sanitary protection – most commonly a washable cloth – and told to call the health worker on the first day of menstruation. Health workers gave each woman a Ziploc bag for the pad and, for privacy, an outer polythene sac.
In Ahmednagar, all women who provided their pad also got screened with Hybrid Capture 2 (HC2; Qiagen) by a mobile screening unit. In Pune, only the positive cases underwent HC2. Screening was also extended to anyone who requested it, but these people were not included in the final analysis.
Genomic DNA was extracted from three 5 mm–sized punches in the pad using a commercial kit, QIAamp DNA Micro, and the quality and purity of the DNA checked by Implen NanoPhotometer.
The team followed the same protocol for PCR HPV assay as the team from Hong Kong.
The results were published in the European Journal of Cancer Prevention in 2018.
The concordance rate for a positive result between the menstrual pad sample and conventional HPV sampling was 98.8% for Ahmednagar and 95.2% for samples from Pune. The sensitivity for the first study was 83% and the specificity 99% – similar to that for the women in Hong Kong. The second study had lower sensitivity and specificity (67% and 88%), partly because of poor storage as a result of frequent power cuts.
The total cost per woman was $30.78.
“I was very excited when we saw the results,” Dr. Budukh recalled. “That day I couldn’t sleep ... such a wonderful result! I was excited to start the next phase immediately.”
Dr. Budukh has applied to the Indian government for funding for a larger trial involving 3,000 women. If successful, he hopes such evidence would be sufficient to convince the Indian government to make menstrual pad screening standard procedure for the 390 million women who live in India’s countryside.
Testing never-screened women for cervical cancer using menstrual pads appears to be relatively reliable, convenient, private, noninvasive, and incredibly cheap.
So who else has tried it?
The first published account of HPV in menstrual blood was a 2003 study by Tommy Tong and colleagues at the Princess Margaret Hospital in Hong Kong. The authors heralded, with lamentable optimism, “a new paradigm in cervical cancer screening.”
In the following 20 years, just six more studies appeared: two from Dr. Budukh’s field trial in India and four from hospital-based pilot studies in Hong Kong (in 2010 and 2018), South Korea (in 2016), and mainland China (in 2021). All these studies, although small, were published in top-flight journals and demonstrate high concordance between conventional high-risk HPV testing and menstrual-blood tests.
This news organization tried to find a U.S. thought-leader who had heard of the approach.
Elizabeth Fontham, MPH, DrPh, is the founding dean of the school of public health at Louisiana State University Health Center in New Orleans, and president of the American Cancer Society. Dr. Fontham said in an email that she had “no plans to evaluate the impact related to menstrual pads, but perhaps others have looked into that.”
Joy Melnikow, MD, MPH, was first author on the evidence synthesis driving the current cervical cancer screening recommendations from the U.S. Preventive Services Task Force. When asked about menstrual pad testing for HPV, she said she had “not heard of it before.”
The USPSTF guidelines don’t mention sanitary pads but acknowledge that “self-collection may be one strategy for increasing screening rates among populations where they are currently low.”
The USPSTF methodology excludes data from countries that don’t match the United States on the Human Development Index “or [are] not applicable to U.S. clinical settings or populations.” (Presumably, data from Hong Kong and South Korea would qualify; Indian data would not.)
Dr. Sahasrabuddhe of the NCI hadn’t heard of menstrual pad testing either, but he has a different explanation for lack of interest in this approach – or, indeed, any form of self-sampling for cervical cancer screening – in the United States.
“We have not seen movement happen in this space for years. ... If there is one intervention that we can simplify, that still has not been made widely available, it is self-sampling ... [but] we don’t have [Food and Drug Administration] approval for it,” Dr. Sahasrabuddhe said.
“Our system, at least in the U.S., is based on industry manufacturers seeking an approval for a particular way of collection and then clinicians and clinical-guideline bodies signing on. ... For a lot of reasons industry has shied away over the past several years, so far, at least, on seeking approval for self-sampling-based approaches,” he commented.
Dr. Sahasrabuddhe aims to change that. He heads a new NCI-led initiative called “The Last Mile,” a nationwide clinical trial supported by federal agencies, industry partners, and professional societies. The goal is to validate self-sampled HPV testing as non-inferior to specimens collected by providers. The team is currently finalizing the methodology of the study, so Dr. Sahasrabuddhe could not share the self-sampling methods that will be on trial, nor the industry partners who have signed up.
The following tests are approved in the United States for physician-collected HPV screening: Hybrid Capture 2, used in the Indian studies (Qiagen); cobas HPV (Roche); Aptima (Hologic); Cervista (Hologic); and Onclarity (Becton Dickinson).
Dr. Sahasrabuddhe said that, while a sanitary pad in a Ziploc bag is unlikely to make the grade for The Last Mile study, he doesn’t totally dismiss their potential and said the NCI is always open to new ideas.
“We are not supporting anybody specifically for menstrual pad-based collection device development,” Dr. Sahasrabuddhe said, “But if they fulfill other criteria for a small business–based grant application, they absolutely are welcome to apply for NCI funding for this.”
Said Dr. Melnikow: “Pre-COVID, the head of [the World Health Organization] said that we could eliminate cervical cancer from the globe and that we have the tools to do that now. And he’s right.”
Dr. Budukh, Dr. Melnikow, and Dr. Sahasrabuddhe disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
A cell phone rings in a red-brick bungalow in a village in India. A woman on the other end of the phone tells Ms. SK, a community health worker, that menstruation has started. Ms. SK guns her scooter through the dusty streets for 15 minutes in 30° C (86° F) heat.
A 32-year-old woman, waiting in the shade of a blue corrugated-iron roof, hands over a green polythene bag. Ms. SK whisks the package to the local health center and tucks it into a –20° C freezer. The following week, it will ride in dry ice to the National Institute for Research in Reproductive and Child Health Laboratory in Mumbai for human papillomavirus (HPV) testing.
This moment in rural India at first glance appears to have little relevance to wealthy countries such as the United States.
However, public health officials in both countries are trying to solve the same problem: how to prevent unnecessary deaths from cervical cancer by reaching women who have never or rarely been screened.
The United States has more in common with India than it may care to admit.
“In the U.S., we still have pockets of disparities that actually have incidence rates [of cervical cancer] comparable to many low- and middle-income countries,” said Vikrant Sahasrabuddhe, MBBS, DrPh, MPH, of the National Cancer Institute, where he heads the HPV and cervical cancer prevention clinical research program for the National Institutes of Health.
The incidence of cervical cancer in India is approximately 19 per 100,000 women. For the past 15 years incidence in the United States has stalled at approximately 7 per 100,000.
In India, there are no organized screening programs and most cervical cancer is regional or distant metastatic at diagnosis.
In the United States, 52% of new cases are advanced, and half of these are among women who have never or rarely been screened.
“There is a critical need for new strategies to reach this population,” Dr. Sahasrabuddhe said. “We absolutely have to do something out of the box creatively.”
Almost all cervical cancers are triggered by HPV, most commonly high-risk HPV-16 and HPV-18, although there are more than 200 types. HPV testing is taking over from cytology (Papanicolaou test) for secondary prevention of cervical cancer.
The trial of screening for HPV in menstrual pads that is ongoing in India was the brainchild of Atul Budukh, PhD, a government public health researcher and professor at the Centre for Cancer Epidemiology, Tata Memorial Centre, Mumbai.
Dr. Budukh’s eyes were opened to the scale of the problem when he participated in a cluster-randomized trial funded by the Bill and Melinda Gates Foundation. The study, published in 2009 in the New England Journal of Medicine, involved 131,746 rural women in the Osmanabad district of India.
A team of researchers from India and France compared outcomes for women over 8 years after cervical screening by HPV, cytology, or visual inspection with acetic acid. The control group was usual care, where women were advised how to seek screening at local hospitals. Women who screened positive were referred for colposcopy, biopsy, and treatment.
Over the 8-year follow-up, advanced cervical cancer was found in twice as many women left to their own devices, compared with women who had HPV testing during the study (82 vs. 39; hazard ratio for HPV, 0.47; 95% confidence interval, 0.32-0.69).
Similarly, cervical cancer deaths in the control group were nearly two times higher than among the women who were screened for HPV in the study (64 vs. 34; HR for HPV, 0.52; 95% CI, 0.33-0.83).
The study proved that rural Indian women were dying unnecessarily because they weren’t seeking cervical screening. And education wasn’t the problem.
“When we go and educate [a rural woman] about ... risk factors and the need to undergo screening, she understands it very well,” said Dr. Budukh. “She is ready to come but her priority is her bread and butter – she will lose her daily wages.”
Dr. Budukh and his team negotiated with local employers so that women could come to screening clinics, but they soon realized this wasn’t scalable.
One year after the NEJM publication, Dr. Budukh found what he was looking for.
A team of Hong Kong clinicians, headed by Sze Chuen Cesar Wong of the Hong Kong Cancer Institute, published a paper in 2010 in the Journal of Clinical Microbiology showing that menstrual pads provide reliable HPV results in women with and without cervical disease.
The Hong Kong team tested sanitary napkins for HPV from 235 of their patients with cervical intraepithelial neoplasia or condyloma acuminatum before and after treatment. Samples were compared with those from 323 women without cervical disease; for HPV in sanitary napkins the sensitivity was 82.8%, specificity was 93.1%, and positive and negative predictive values were 90% and 87.9%, respectively.
The authors pointed out that menstrual pad testing was the only truly noninvasive approach to HPV screening versus the other self-sampling methods such as tampons and cytobrushes. Also, these self-sampling tests require specialized liquid-based transport media. A menstrual pad needs only a plastic bag.
Dr. Budukh had his at-home solution for the hard-working rural women of India.
With funding from the Indian government, Dr. Budukh’s team put together a validation trial that ran from 2013 to 2016 in 18 rural villages in two separate districts: Ahmednagar and Pune.
Local health workers went house to house to recruit women and get family buy-in for this culturally delicate project. Participants were instructed to use their regular sanitary protection – most commonly a washable cloth – and told to call the health worker on the first day of menstruation. Health workers gave each woman a Ziploc bag for the pad and, for privacy, an outer polythene sac.
In Ahmednagar, all women who provided their pad also got screened with Hybrid Capture 2 (HC2; Qiagen) by a mobile screening unit. In Pune, only the positive cases underwent HC2. Screening was also extended to anyone who requested it, but these people were not included in the final analysis.
Genomic DNA was extracted from three 5 mm–sized punches in the pad using a commercial kit, QIAamp DNA Micro, and the quality and purity of the DNA checked by Implen NanoPhotometer.
The team followed the same protocol for PCR HPV assay as the team from Hong Kong.
The results were published in the European Journal of Cancer Prevention in 2018.
The concordance rate for a positive result between the menstrual pad sample and conventional HPV sampling was 98.8% for Ahmednagar and 95.2% for samples from Pune. The sensitivity for the first study was 83% and the specificity 99% – similar to that for the women in Hong Kong. The second study had lower sensitivity and specificity (67% and 88%), partly because of poor storage as a result of frequent power cuts.
The total cost per woman was $30.78.
“I was very excited when we saw the results,” Dr. Budukh recalled. “That day I couldn’t sleep ... such a wonderful result! I was excited to start the next phase immediately.”
Dr. Budukh has applied to the Indian government for funding for a larger trial involving 3,000 women. If successful, he hopes such evidence would be sufficient to convince the Indian government to make menstrual pad screening standard procedure for the 390 million women who live in India’s countryside.
Testing never-screened women for cervical cancer using menstrual pads appears to be relatively reliable, convenient, private, noninvasive, and incredibly cheap.
So who else has tried it?
The first published account of HPV in menstrual blood was a 2003 study by Tommy Tong and colleagues at the Princess Margaret Hospital in Hong Kong. The authors heralded, with lamentable optimism, “a new paradigm in cervical cancer screening.”
In the following 20 years, just six more studies appeared: two from Dr. Budukh’s field trial in India and four from hospital-based pilot studies in Hong Kong (in 2010 and 2018), South Korea (in 2016), and mainland China (in 2021). All these studies, although small, were published in top-flight journals and demonstrate high concordance between conventional high-risk HPV testing and menstrual-blood tests.
This news organization tried to find a U.S. thought-leader who had heard of the approach.
Elizabeth Fontham, MPH, DrPh, is the founding dean of the school of public health at Louisiana State University Health Center in New Orleans, and president of the American Cancer Society. Dr. Fontham said in an email that she had “no plans to evaluate the impact related to menstrual pads, but perhaps others have looked into that.”
Joy Melnikow, MD, MPH, was first author on the evidence synthesis driving the current cervical cancer screening recommendations from the U.S. Preventive Services Task Force. When asked about menstrual pad testing for HPV, she said she had “not heard of it before.”
The USPSTF guidelines don’t mention sanitary pads but acknowledge that “self-collection may be one strategy for increasing screening rates among populations where they are currently low.”
The USPSTF methodology excludes data from countries that don’t match the United States on the Human Development Index “or [are] not applicable to U.S. clinical settings or populations.” (Presumably, data from Hong Kong and South Korea would qualify; Indian data would not.)
Dr. Sahasrabuddhe of the NCI hadn’t heard of menstrual pad testing either, but he has a different explanation for lack of interest in this approach – or, indeed, any form of self-sampling for cervical cancer screening – in the United States.
“We have not seen movement happen in this space for years. ... If there is one intervention that we can simplify, that still has not been made widely available, it is self-sampling ... [but] we don’t have [Food and Drug Administration] approval for it,” Dr. Sahasrabuddhe said.
“Our system, at least in the U.S., is based on industry manufacturers seeking an approval for a particular way of collection and then clinicians and clinical-guideline bodies signing on. ... For a lot of reasons industry has shied away over the past several years, so far, at least, on seeking approval for self-sampling-based approaches,” he commented.
Dr. Sahasrabuddhe aims to change that. He heads a new NCI-led initiative called “The Last Mile,” a nationwide clinical trial supported by federal agencies, industry partners, and professional societies. The goal is to validate self-sampled HPV testing as non-inferior to specimens collected by providers. The team is currently finalizing the methodology of the study, so Dr. Sahasrabuddhe could not share the self-sampling methods that will be on trial, nor the industry partners who have signed up.
The following tests are approved in the United States for physician-collected HPV screening: Hybrid Capture 2, used in the Indian studies (Qiagen); cobas HPV (Roche); Aptima (Hologic); Cervista (Hologic); and Onclarity (Becton Dickinson).
Dr. Sahasrabuddhe said that, while a sanitary pad in a Ziploc bag is unlikely to make the grade for The Last Mile study, he doesn’t totally dismiss their potential and said the NCI is always open to new ideas.
“We are not supporting anybody specifically for menstrual pad-based collection device development,” Dr. Sahasrabuddhe said, “But if they fulfill other criteria for a small business–based grant application, they absolutely are welcome to apply for NCI funding for this.”
Said Dr. Melnikow: “Pre-COVID, the head of [the World Health Organization] said that we could eliminate cervical cancer from the globe and that we have the tools to do that now. And he’s right.”
Dr. Budukh, Dr. Melnikow, and Dr. Sahasrabuddhe disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
What are the reasons to use the Gail risk assessment model?
Text copyright DenseBreast-info.org.
Answer
B. The Gail risk model1-3 is used to predict 5-year and lifetime risks of developing invasive breast cancer, and to identify women who may benefit from risk-reducing medications such as tamoxifen. The Gail model should not be used to determine risk for purposes of screening magnetic resonance imaging (MRI)4 (or genetic testing).
Breast cancer risk models are used to stratify patients into risk categories to facilitate personalized screening and surveillance plans for clinical management. Several breast cancer risk assessment tools have been developed that include different combinations of known risk factors and are used for the following purposes:
1. To identify women who may benefit from risk-reducing medications. The Gail model is used to determine risk for purposes of advising on use of risk-reducing medications. Any woman with a 5-year risk ≥1.67% by the Gail model may be considered for treatment with tamoxifen (pre or postmenopausal), raloxifene (postmenopausal), or aromatase inhibitors (postmenopausal).5
In the National Surgical Adjuvant Breast and Bowel Project (NSABP) P1 study,6 women at increased risk for breast cancer were defined as follows:
- age 35 to 59 years with at least a 1.66% 5-year risk for developing breast cancer by the Gail model
- personal history of lobular carcinoma in situ (LCIS)
- age over 60 years.
More than 13,000 such women were randomly assigned to receive tamoxifen or placebo daily for 5 years. Tamoxifen reduced the risk of invasive breast cancer by 49% and reduced the risk of noninvasive cancer by 50% compared with placebo. The reduced risk of breast cancer was only seen for estrogen-receptor–expressing tumors. There was a 2.5-fold increase in risk of endometrial cancer in women taking tamoxifen and a decrease in hip and spine fracture risk. Blood clots causing stroke and deep vein thrombosis are increased in women taking tamoxifen.7,8
2. To identify women who may carry a pathogenic mutation in BRCA1 or BRCA2. Some models (eg, Tyrer-Cuzick [IBIS],9 Penn II,10 BOADICEA,11 and BRCAPRO12) estimate the probability of a BRCA1/2 mutation; however, most testing guidelines are now criterion based (eg, National Comprehensive Cancer Network [NCCN]) as opposed to probability based. In practical terms, clinical decision making around genetic testing is rarely based on a priori probabilities.
3. To identify women who meet criteria for high-risk screening MRI. Current American Cancer Society (ACS) guidelines4 recommend annual screening MRI, in addition to mammography, beginning by age 25 to 30 in women who have a lifetime risk of breast cancer ≥20%. Any of the models used to predict risk of a pathogenic mutation (Tyrer-Cuzick [IBIS], Penn II, BOADICEA, BRCAPRO),or the Claus model,13 but not the Gail model, can be used to estimate lifetime risk for purposes of screening MRI guidelines. The ACS and NCCN guidelines specifically recommend against using the Gail model to determine risk for purposes of MRI screening or risk of pathogenic mutation, as it does not include detailed family history such as age at diagnosis or second-degree relatives.
ACS and NCCN guidelines also recommend annual screening MRI beginning by age 25, with the addition of mammography beginning at age 30, in women who are known to carry pathogenic mutations in BRCA1 or BRCA2 (unless the woman has had bilateral mastectomy), and in women who are first-degree relatives of known mutation carriers but who are themselves untested.14
Women who are known to carry or are first-degree untested relatives of individuals with less common disease-causing mutations (such as those associated with Li-Fraumeni syndrome, Bannayan-Riley-Ruvalcaba syndrome, hereditary diffuse gastric cancer, Peutz-Jeghers syndrome, Cowden syndrome, Neurofibromatosis type 1, or Fanconi anemia) are also recommended for annual screening MRI beginning between ages 20-35, depending on the mutation.14 Women with known pathogenic mutations in ATM, CHEK2, or NBN should consider annual MRI starting at age 40 or 5-10 years before the earliest known breast cancer in the family (whichever comes first).
Finally, women with prior chest radiation therapy (such as for Hodgkin disease) between ages 10 and 30 are at high risk for developing breast cancer,4,15,16 with risk similar in magnitude to pathogenic BRCA1 or BRCA2 carriers. These women are also recommended for annual screening MRI starting at age 25 or 8 years after the chest radiation therapy, whichever is later.
Currently the Tyrer-Cuzick Model (IBIS) version 817 and the Breast Cancer Surveillance Consortium (BCSC) models18 include breast density in risk calculations; the Gail, Penn II, and Claus models do not include breast density.
Adding polygenic risk scores based on single nucleotide polymorphisms to traditional comprehensive risk models such as the Tyrer-Cuzick model has been shown to improve model performance.19 In addition, artificial intelligence is being used to identify textural and other findings beyond breast density on mammograms that predict increased risk. Such information, which is complementary to the Tyrer-Cuzick model (v.8),20 has more accurately identified high-risk patients than the Tyrer-Cuzick v8 risk model and prior deep learning models.21
In a study from the Karolinska Institute, a model that included computer-aided detection of microcalcifications and masses in addition to other traditional risk factors (including breast density) successfully identified women who would develop interval or advanced cancer in the 2 years after a normal mammogram and improved short-term (2-to-3-year) risk assessment over TyrerCuzick (v.7) or Gail models.22 This model proved more accurate than traditional risk models and can augment genetic/family history to help identify women who should and, importantly, who should not, have supplemental screening after 2D mammography. Risk models that include detailed family history should be used rather than the Gail model to identify women who meet high risk criteria for MRI screening. Research also supports the benefits of MRI in women with dense breasts who are not otherwise considered “high risk,” and while not widely available, lower cost, abbreviated MRI protocols have been validated for all women with dense breasts.23 For more details on risk models, including a risk models table with live links to commonly used breast cancer risk assessment tools, visit https://densebreast-info .org/for-providers/risk-model-tutorial/. ●
For more information, visit medically sourced DenseBreastinfo.org. Comprehensive resources include a free CME opportunity, Dense Breasts and Supplemental Screening.
- The Breast Cancer Risk Assessment Tool. https://bcrisktool .cancer.gov/calculator.html. Accessed March 15, 2022.
- Gail MH, Brinton LA, Byar DP, et al. Projecting individualized probabilities of developing breast cancer for white females who are being examined annually. J Natl Cancer Inst. 1989;81:1879-1886.
- Gail MH, Costantino JP, Pee D, et al. Projecting individualized absolute invasive breast cancer risk in African American women. J Natl Cancer Inst. 2007;99:1782-1792.
- Saslow D, Boetes C, Burke W, et al. American Cancer Society guidelines for breast screening with MRI as an adjunct to mammography. CA Cancer J Clin. 2007;57:75-89.
- Network NCC. Breast Cancer Risk Reduction (Version 1.2022). https://www.nccn.org/professionals/physician_gls /pdf/breast_risk.pdf. Published 2022. Accessed February 8, 2022.
- Fisher B, Costantino JP, Wickerham DL, et al. Tamoxifen for prevention of breast cancer: report of the National Surgical Adjuvant Breast and Bowel Project P-1 Study. J Natl Cancer Inst. 1998;90:1371-1388.
- Fisher B, Costantino JP, Wickerham DL, et al. Tamoxifen for the prevention of breast cancer: current status of the National Surgical Adjuvant Breast and Bowel Project P-1 study. J Natl Cancer Inst. 2005;97:1652-1662.
- Hernandez RK, Sorensen HT, Pedersen L, et al. Tamoxifen
treatment and risk of deep venous thrombosis and pulmonary embolism: a Danish population-based cohort study. Cancer. 2009;115:4442-4449. - Tyrer J, Duffy SW, Cuzick J. A breast cancer prediction model incorporating familial and personal risk factors. Stat Med. 2004;23:1111-1130.
- Panchal SM, Ennis M, Canon S, et al. Selecting a BRCA risk assessment model for use in a familial cancer clinic. BMC Med Genet. 2008;9:116.
- Antoniou AC, Pharoah PP, Smith P, et al. The BOADICEA model of genetic susceptibility to breast and ovarian cancer. Br J Cancer. 2004;91:1580-1590.
- Berry DA, Iversen ES, Jr., Gudbjartsson DF, et al. BRCAPRO validation, sensitivity of genetic testing of BRCA1/BRCA2, and prevalence of other breast cancer susceptibility genes.
J Clin Oncol. 2002;20:2701-2712. - Claus EB, Risch N, Thompson WD. Autosomal dominant inheritance of early-onset breast cancer. Implications for risk prediction. Cancer. 1994;73:643-651.
- Network NCC. Genetic/Familial High-Risk Assessment: Breast, Ovarian, and Pancreatic (Version 1.2022). https:// www.nccn.org/professionals/physician_gls/pdf/genetics _bop.pdf. Accessed February 9, 2022.
- Monticciolo DL, Newell MS, Moy L, et al. Breast cancer screening in women at higher-than-average risk: recommendations from the ACR. J Am Coll Radiol. 2018;15(3 Pt A):408-414.
- Oeffinger KC, Ford JS, Moskowitz CS, et al. Breast cancer surveillance practices among women previously treated with chest radiation for a childhood cancer. JAMA. 2009;301: 404-414.
- Brentnall AR, Cuzick J, Buist DSM, et al. Long-term accuracy of breast cancer risk assessment combining classic risk factors and breast density. JAMA Oncol. 2018;4:e180174.
- Tice JA, Cummings SR, Smith-Bindman R, et al. Using clinical factors and mammographic breast density to estimate breast cancer risk: development and validation of a new predictive model. Ann Intern Med. 2008;148:337-347.
- Brentnall AR, van Veen EM, Harkness EF, et al. A case-control evaluation of 143 single nucleotide polymorphisms for breast cancer risk stratification with classical factors and mammographic density. Int J Cancer. 2020;146:2122-2129.
- Yala A, Lehman C, Schuster T, et al. A deep learning mammography-based model for improved breast cancer risk prediction. Radiology. 2019;292:60-66.
- Yala A, Mikhael PG, Strand F, et al. Toward robust mammography-based models for breast cancer risk. Sci Transl Med. 2021;13.
- Eriksson M, Czene K, Pawitan Y, et al. A clinical model for identifying the short-term risk of breast cancer. Breast Cancer Res. 2017;19:29.
- Comstock CE, Gatsonis C, Newstead GM, et al. Comparison of abbreviated breast MRI vs digital breast tomosynthesis for breast cancer detection among women with dense breasts undergoing screening. JAMA. 2020;323:746-756.
Text copyright DenseBreast-info.org.
Answer
B. The Gail risk model1-3 is used to predict 5-year and lifetime risks of developing invasive breast cancer, and to identify women who may benefit from risk-reducing medications such as tamoxifen. The Gail model should not be used to determine risk for purposes of screening magnetic resonance imaging (MRI)4 (or genetic testing).
Breast cancer risk models are used to stratify patients into risk categories to facilitate personalized screening and surveillance plans for clinical management. Several breast cancer risk assessment tools have been developed that include different combinations of known risk factors and are used for the following purposes:
1. To identify women who may benefit from risk-reducing medications. The Gail model is used to determine risk for purposes of advising on use of risk-reducing medications. Any woman with a 5-year risk ≥1.67% by the Gail model may be considered for treatment with tamoxifen (pre or postmenopausal), raloxifene (postmenopausal), or aromatase inhibitors (postmenopausal).5
In the National Surgical Adjuvant Breast and Bowel Project (NSABP) P1 study,6 women at increased risk for breast cancer were defined as follows:
- age 35 to 59 years with at least a 1.66% 5-year risk for developing breast cancer by the Gail model
- personal history of lobular carcinoma in situ (LCIS)
- age over 60 years.
More than 13,000 such women were randomly assigned to receive tamoxifen or placebo daily for 5 years. Tamoxifen reduced the risk of invasive breast cancer by 49% and reduced the risk of noninvasive cancer by 50% compared with placebo. The reduced risk of breast cancer was only seen for estrogen-receptor–expressing tumors. There was a 2.5-fold increase in risk of endometrial cancer in women taking tamoxifen and a decrease in hip and spine fracture risk. Blood clots causing stroke and deep vein thrombosis are increased in women taking tamoxifen.7,8
2. To identify women who may carry a pathogenic mutation in BRCA1 or BRCA2. Some models (eg, Tyrer-Cuzick [IBIS],9 Penn II,10 BOADICEA,11 and BRCAPRO12) estimate the probability of a BRCA1/2 mutation; however, most testing guidelines are now criterion based (eg, National Comprehensive Cancer Network [NCCN]) as opposed to probability based. In practical terms, clinical decision making around genetic testing is rarely based on a priori probabilities.
3. To identify women who meet criteria for high-risk screening MRI. Current American Cancer Society (ACS) guidelines4 recommend annual screening MRI, in addition to mammography, beginning by age 25 to 30 in women who have a lifetime risk of breast cancer ≥20%. Any of the models used to predict risk of a pathogenic mutation (Tyrer-Cuzick [IBIS], Penn II, BOADICEA, BRCAPRO),or the Claus model,13 but not the Gail model, can be used to estimate lifetime risk for purposes of screening MRI guidelines. The ACS and NCCN guidelines specifically recommend against using the Gail model to determine risk for purposes of MRI screening or risk of pathogenic mutation, as it does not include detailed family history such as age at diagnosis or second-degree relatives.
ACS and NCCN guidelines also recommend annual screening MRI beginning by age 25, with the addition of mammography beginning at age 30, in women who are known to carry pathogenic mutations in BRCA1 or BRCA2 (unless the woman has had bilateral mastectomy), and in women who are first-degree relatives of known mutation carriers but who are themselves untested.14
Women who are known to carry or are first-degree untested relatives of individuals with less common disease-causing mutations (such as those associated with Li-Fraumeni syndrome, Bannayan-Riley-Ruvalcaba syndrome, hereditary diffuse gastric cancer, Peutz-Jeghers syndrome, Cowden syndrome, Neurofibromatosis type 1, or Fanconi anemia) are also recommended for annual screening MRI beginning between ages 20-35, depending on the mutation.14 Women with known pathogenic mutations in ATM, CHEK2, or NBN should consider annual MRI starting at age 40 or 5-10 years before the earliest known breast cancer in the family (whichever comes first).
Finally, women with prior chest radiation therapy (such as for Hodgkin disease) between ages 10 and 30 are at high risk for developing breast cancer,4,15,16 with risk similar in magnitude to pathogenic BRCA1 or BRCA2 carriers. These women are also recommended for annual screening MRI starting at age 25 or 8 years after the chest radiation therapy, whichever is later.
Currently the Tyrer-Cuzick Model (IBIS) version 817 and the Breast Cancer Surveillance Consortium (BCSC) models18 include breast density in risk calculations; the Gail, Penn II, and Claus models do not include breast density.
Adding polygenic risk scores based on single nucleotide polymorphisms to traditional comprehensive risk models such as the Tyrer-Cuzick model has been shown to improve model performance.19 In addition, artificial intelligence is being used to identify textural and other findings beyond breast density on mammograms that predict increased risk. Such information, which is complementary to the Tyrer-Cuzick model (v.8),20 has more accurately identified high-risk patients than the Tyrer-Cuzick v8 risk model and prior deep learning models.21
In a study from the Karolinska Institute, a model that included computer-aided detection of microcalcifications and masses in addition to other traditional risk factors (including breast density) successfully identified women who would develop interval or advanced cancer in the 2 years after a normal mammogram and improved short-term (2-to-3-year) risk assessment over TyrerCuzick (v.7) or Gail models.22 This model proved more accurate than traditional risk models and can augment genetic/family history to help identify women who should and, importantly, who should not, have supplemental screening after 2D mammography. Risk models that include detailed family history should be used rather than the Gail model to identify women who meet high risk criteria for MRI screening. Research also supports the benefits of MRI in women with dense breasts who are not otherwise considered “high risk,” and while not widely available, lower cost, abbreviated MRI protocols have been validated for all women with dense breasts.23 For more details on risk models, including a risk models table with live links to commonly used breast cancer risk assessment tools, visit https://densebreast-info .org/for-providers/risk-model-tutorial/. ●
For more information, visit medically sourced DenseBreastinfo.org. Comprehensive resources include a free CME opportunity, Dense Breasts and Supplemental Screening.
Text copyright DenseBreast-info.org.
Answer
B. The Gail risk model1-3 is used to predict 5-year and lifetime risks of developing invasive breast cancer, and to identify women who may benefit from risk-reducing medications such as tamoxifen. The Gail model should not be used to determine risk for purposes of screening magnetic resonance imaging (MRI)4 (or genetic testing).
Breast cancer risk models are used to stratify patients into risk categories to facilitate personalized screening and surveillance plans for clinical management. Several breast cancer risk assessment tools have been developed that include different combinations of known risk factors and are used for the following purposes:
1. To identify women who may benefit from risk-reducing medications. The Gail model is used to determine risk for purposes of advising on use of risk-reducing medications. Any woman with a 5-year risk ≥1.67% by the Gail model may be considered for treatment with tamoxifen (pre or postmenopausal), raloxifene (postmenopausal), or aromatase inhibitors (postmenopausal).5
In the National Surgical Adjuvant Breast and Bowel Project (NSABP) P1 study,6 women at increased risk for breast cancer were defined as follows:
- age 35 to 59 years with at least a 1.66% 5-year risk for developing breast cancer by the Gail model
- personal history of lobular carcinoma in situ (LCIS)
- age over 60 years.
More than 13,000 such women were randomly assigned to receive tamoxifen or placebo daily for 5 years. Tamoxifen reduced the risk of invasive breast cancer by 49% and reduced the risk of noninvasive cancer by 50% compared with placebo. The reduced risk of breast cancer was only seen for estrogen-receptor–expressing tumors. There was a 2.5-fold increase in risk of endometrial cancer in women taking tamoxifen and a decrease in hip and spine fracture risk. Blood clots causing stroke and deep vein thrombosis are increased in women taking tamoxifen.7,8
2. To identify women who may carry a pathogenic mutation in BRCA1 or BRCA2. Some models (eg, Tyrer-Cuzick [IBIS],9 Penn II,10 BOADICEA,11 and BRCAPRO12) estimate the probability of a BRCA1/2 mutation; however, most testing guidelines are now criterion based (eg, National Comprehensive Cancer Network [NCCN]) as opposed to probability based. In practical terms, clinical decision making around genetic testing is rarely based on a priori probabilities.
3. To identify women who meet criteria for high-risk screening MRI. Current American Cancer Society (ACS) guidelines4 recommend annual screening MRI, in addition to mammography, beginning by age 25 to 30 in women who have a lifetime risk of breast cancer ≥20%. Any of the models used to predict risk of a pathogenic mutation (Tyrer-Cuzick [IBIS], Penn II, BOADICEA, BRCAPRO),or the Claus model,13 but not the Gail model, can be used to estimate lifetime risk for purposes of screening MRI guidelines. The ACS and NCCN guidelines specifically recommend against using the Gail model to determine risk for purposes of MRI screening or risk of pathogenic mutation, as it does not include detailed family history such as age at diagnosis or second-degree relatives.
ACS and NCCN guidelines also recommend annual screening MRI beginning by age 25, with the addition of mammography beginning at age 30, in women who are known to carry pathogenic mutations in BRCA1 or BRCA2 (unless the woman has had bilateral mastectomy), and in women who are first-degree relatives of known mutation carriers but who are themselves untested.14
Women who are known to carry or are first-degree untested relatives of individuals with less common disease-causing mutations (such as those associated with Li-Fraumeni syndrome, Bannayan-Riley-Ruvalcaba syndrome, hereditary diffuse gastric cancer, Peutz-Jeghers syndrome, Cowden syndrome, Neurofibromatosis type 1, or Fanconi anemia) are also recommended for annual screening MRI beginning between ages 20-35, depending on the mutation.14 Women with known pathogenic mutations in ATM, CHEK2, or NBN should consider annual MRI starting at age 40 or 5-10 years before the earliest known breast cancer in the family (whichever comes first).
Finally, women with prior chest radiation therapy (such as for Hodgkin disease) between ages 10 and 30 are at high risk for developing breast cancer,4,15,16 with risk similar in magnitude to pathogenic BRCA1 or BRCA2 carriers. These women are also recommended for annual screening MRI starting at age 25 or 8 years after the chest radiation therapy, whichever is later.
Currently the Tyrer-Cuzick Model (IBIS) version 817 and the Breast Cancer Surveillance Consortium (BCSC) models18 include breast density in risk calculations; the Gail, Penn II, and Claus models do not include breast density.
Adding polygenic risk scores based on single nucleotide polymorphisms to traditional comprehensive risk models such as the Tyrer-Cuzick model has been shown to improve model performance.19 In addition, artificial intelligence is being used to identify textural and other findings beyond breast density on mammograms that predict increased risk. Such information, which is complementary to the Tyrer-Cuzick model (v.8),20 has more accurately identified high-risk patients than the Tyrer-Cuzick v8 risk model and prior deep learning models.21
In a study from the Karolinska Institute, a model that included computer-aided detection of microcalcifications and masses in addition to other traditional risk factors (including breast density) successfully identified women who would develop interval or advanced cancer in the 2 years after a normal mammogram and improved short-term (2-to-3-year) risk assessment over TyrerCuzick (v.7) or Gail models.22 This model proved more accurate than traditional risk models and can augment genetic/family history to help identify women who should and, importantly, who should not, have supplemental screening after 2D mammography. Risk models that include detailed family history should be used rather than the Gail model to identify women who meet high risk criteria for MRI screening. Research also supports the benefits of MRI in women with dense breasts who are not otherwise considered “high risk,” and while not widely available, lower cost, abbreviated MRI protocols have been validated for all women with dense breasts.23 For more details on risk models, including a risk models table with live links to commonly used breast cancer risk assessment tools, visit https://densebreast-info .org/for-providers/risk-model-tutorial/. ●
For more information, visit medically sourced DenseBreastinfo.org. Comprehensive resources include a free CME opportunity, Dense Breasts and Supplemental Screening.
- The Breast Cancer Risk Assessment Tool. https://bcrisktool .cancer.gov/calculator.html. Accessed March 15, 2022.
- Gail MH, Brinton LA, Byar DP, et al. Projecting individualized probabilities of developing breast cancer for white females who are being examined annually. J Natl Cancer Inst. 1989;81:1879-1886.
- Gail MH, Costantino JP, Pee D, et al. Projecting individualized absolute invasive breast cancer risk in African American women. J Natl Cancer Inst. 2007;99:1782-1792.
- Saslow D, Boetes C, Burke W, et al. American Cancer Society guidelines for breast screening with MRI as an adjunct to mammography. CA Cancer J Clin. 2007;57:75-89.
- Network NCC. Breast Cancer Risk Reduction (Version 1.2022). https://www.nccn.org/professionals/physician_gls /pdf/breast_risk.pdf. Published 2022. Accessed February 8, 2022.
- Fisher B, Costantino JP, Wickerham DL, et al. Tamoxifen for prevention of breast cancer: report of the National Surgical Adjuvant Breast and Bowel Project P-1 Study. J Natl Cancer Inst. 1998;90:1371-1388.
- Fisher B, Costantino JP, Wickerham DL, et al. Tamoxifen for the prevention of breast cancer: current status of the National Surgical Adjuvant Breast and Bowel Project P-1 study. J Natl Cancer Inst. 2005;97:1652-1662.
- Hernandez RK, Sorensen HT, Pedersen L, et al. Tamoxifen
treatment and risk of deep venous thrombosis and pulmonary embolism: a Danish population-based cohort study. Cancer. 2009;115:4442-4449. - Tyrer J, Duffy SW, Cuzick J. A breast cancer prediction model incorporating familial and personal risk factors. Stat Med. 2004;23:1111-1130.
- Panchal SM, Ennis M, Canon S, et al. Selecting a BRCA risk assessment model for use in a familial cancer clinic. BMC Med Genet. 2008;9:116.
- Antoniou AC, Pharoah PP, Smith P, et al. The BOADICEA model of genetic susceptibility to breast and ovarian cancer. Br J Cancer. 2004;91:1580-1590.
- Berry DA, Iversen ES, Jr., Gudbjartsson DF, et al. BRCAPRO validation, sensitivity of genetic testing of BRCA1/BRCA2, and prevalence of other breast cancer susceptibility genes.
J Clin Oncol. 2002;20:2701-2712. - Claus EB, Risch N, Thompson WD. Autosomal dominant inheritance of early-onset breast cancer. Implications for risk prediction. Cancer. 1994;73:643-651.
- Network NCC. Genetic/Familial High-Risk Assessment: Breast, Ovarian, and Pancreatic (Version 1.2022). https:// www.nccn.org/professionals/physician_gls/pdf/genetics _bop.pdf. Accessed February 9, 2022.
- Monticciolo DL, Newell MS, Moy L, et al. Breast cancer screening in women at higher-than-average risk: recommendations from the ACR. J Am Coll Radiol. 2018;15(3 Pt A):408-414.
- Oeffinger KC, Ford JS, Moskowitz CS, et al. Breast cancer surveillance practices among women previously treated with chest radiation for a childhood cancer. JAMA. 2009;301: 404-414.
- Brentnall AR, Cuzick J, Buist DSM, et al. Long-term accuracy of breast cancer risk assessment combining classic risk factors and breast density. JAMA Oncol. 2018;4:e180174.
- Tice JA, Cummings SR, Smith-Bindman R, et al. Using clinical factors and mammographic breast density to estimate breast cancer risk: development and validation of a new predictive model. Ann Intern Med. 2008;148:337-347.
- Brentnall AR, van Veen EM, Harkness EF, et al. A case-control evaluation of 143 single nucleotide polymorphisms for breast cancer risk stratification with classical factors and mammographic density. Int J Cancer. 2020;146:2122-2129.
- Yala A, Lehman C, Schuster T, et al. A deep learning mammography-based model for improved breast cancer risk prediction. Radiology. 2019;292:60-66.
- Yala A, Mikhael PG, Strand F, et al. Toward robust mammography-based models for breast cancer risk. Sci Transl Med. 2021;13.
- Eriksson M, Czene K, Pawitan Y, et al. A clinical model for identifying the short-term risk of breast cancer. Breast Cancer Res. 2017;19:29.
- Comstock CE, Gatsonis C, Newstead GM, et al. Comparison of abbreviated breast MRI vs digital breast tomosynthesis for breast cancer detection among women with dense breasts undergoing screening. JAMA. 2020;323:746-756.
- The Breast Cancer Risk Assessment Tool. https://bcrisktool .cancer.gov/calculator.html. Accessed March 15, 2022.
- Gail MH, Brinton LA, Byar DP, et al. Projecting individualized probabilities of developing breast cancer for white females who are being examined annually. J Natl Cancer Inst. 1989;81:1879-1886.
- Gail MH, Costantino JP, Pee D, et al. Projecting individualized absolute invasive breast cancer risk in African American women. J Natl Cancer Inst. 2007;99:1782-1792.
- Saslow D, Boetes C, Burke W, et al. American Cancer Society guidelines for breast screening with MRI as an adjunct to mammography. CA Cancer J Clin. 2007;57:75-89.
- Network NCC. Breast Cancer Risk Reduction (Version 1.2022). https://www.nccn.org/professionals/physician_gls /pdf/breast_risk.pdf. Published 2022. Accessed February 8, 2022.
- Fisher B, Costantino JP, Wickerham DL, et al. Tamoxifen for prevention of breast cancer: report of the National Surgical Adjuvant Breast and Bowel Project P-1 Study. J Natl Cancer Inst. 1998;90:1371-1388.
- Fisher B, Costantino JP, Wickerham DL, et al. Tamoxifen for the prevention of breast cancer: current status of the National Surgical Adjuvant Breast and Bowel Project P-1 study. J Natl Cancer Inst. 2005;97:1652-1662.
- Hernandez RK, Sorensen HT, Pedersen L, et al. Tamoxifen
treatment and risk of deep venous thrombosis and pulmonary embolism: a Danish population-based cohort study. Cancer. 2009;115:4442-4449. - Tyrer J, Duffy SW, Cuzick J. A breast cancer prediction model incorporating familial and personal risk factors. Stat Med. 2004;23:1111-1130.
- Panchal SM, Ennis M, Canon S, et al. Selecting a BRCA risk assessment model for use in a familial cancer clinic. BMC Med Genet. 2008;9:116.
- Antoniou AC, Pharoah PP, Smith P, et al. The BOADICEA model of genetic susceptibility to breast and ovarian cancer. Br J Cancer. 2004;91:1580-1590.
- Berry DA, Iversen ES, Jr., Gudbjartsson DF, et al. BRCAPRO validation, sensitivity of genetic testing of BRCA1/BRCA2, and prevalence of other breast cancer susceptibility genes.
J Clin Oncol. 2002;20:2701-2712. - Claus EB, Risch N, Thompson WD. Autosomal dominant inheritance of early-onset breast cancer. Implications for risk prediction. Cancer. 1994;73:643-651.
- Network NCC. Genetic/Familial High-Risk Assessment: Breast, Ovarian, and Pancreatic (Version 1.2022). https:// www.nccn.org/professionals/physician_gls/pdf/genetics _bop.pdf. Accessed February 9, 2022.
- Monticciolo DL, Newell MS, Moy L, et al. Breast cancer screening in women at higher-than-average risk: recommendations from the ACR. J Am Coll Radiol. 2018;15(3 Pt A):408-414.
- Oeffinger KC, Ford JS, Moskowitz CS, et al. Breast cancer surveillance practices among women previously treated with chest radiation for a childhood cancer. JAMA. 2009;301: 404-414.
- Brentnall AR, Cuzick J, Buist DSM, et al. Long-term accuracy of breast cancer risk assessment combining classic risk factors and breast density. JAMA Oncol. 2018;4:e180174.
- Tice JA, Cummings SR, Smith-Bindman R, et al. Using clinical factors and mammographic breast density to estimate breast cancer risk: development and validation of a new predictive model. Ann Intern Med. 2008;148:337-347.
- Brentnall AR, van Veen EM, Harkness EF, et al. A case-control evaluation of 143 single nucleotide polymorphisms for breast cancer risk stratification with classical factors and mammographic density. Int J Cancer. 2020;146:2122-2129.
- Yala A, Lehman C, Schuster T, et al. A deep learning mammography-based model for improved breast cancer risk prediction. Radiology. 2019;292:60-66.
- Yala A, Mikhael PG, Strand F, et al. Toward robust mammography-based models for breast cancer risk. Sci Transl Med. 2021;13.
- Eriksson M, Czene K, Pawitan Y, et al. A clinical model for identifying the short-term risk of breast cancer. Breast Cancer Res. 2017;19:29.
- Comstock CE, Gatsonis C, Newstead GM, et al. Comparison of abbreviated breast MRI vs digital breast tomosynthesis for breast cancer detection among women with dense breasts undergoing screening. JAMA. 2020;323:746-756.
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