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Fourth Pfizer dose better for severe than symptomatic COVID: Study
A fourth dose of the Pfizer-BioNTech vaccine is effective in reducing the short-term risk for COVID-19 infection, hospitalization, and death in people who got a third dose at least 4 months before, a large study shows.
However, Paul Offit, MD, author of an editorial accompanying the study, told this news organization, “I would argue, without fear of contradiction, that this is going to have no impact on this pandemic.”
“We are still in the midst of a zero-tolerance policy for this virus. We don’t accept mild illness and if we’re not going to accept mild illness, we think we have to boost it away, which would mean probably about two doses every year. That’s not a reasonable public health strategy,” said Dr. Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia.
Booster confusion
Results of the research out of Israel, published in the New England Journal of Medicine, make a case for a fourth booster for people 60 and over.
Researchers, led by Ori Magen, MD, Clalit Research Institute, innovation division, Clalit Health Services, Tel Aviv, analyzed data comparing 182,122 matched pairs recorded by the largest health care organization in Israel from Jan. 3 to Feb. 18, 2022. With more than 4.7 million members, Clalit Health Services covers more than half of the population of Israel.
The researchers compared outcomes in people 60 or older (average age, 72 years) who got a fourth dose with outcomes in those who had only a third dose. They individually matched people from the two groups, considering factors such as age, health status, and ethnicity.
Relative vaccine effectiveness in days 7-30 after the fourth dose was estimated to be 45% (95% confidence interval, 44%-47%) against confirmed SARS-CoV-2 infection, 55% (95% CI, 53%-58%) against symptomatic COVID-19, 68% (95% CI, 59%-74%) against hospitalization, 62% (95% CI, 50%-74%) against severe COVID, and 74% (95% CI, 50%-90%) against COVID-related death.
Several countries, including the United States, have begun offering a fourth vaccine dose for higher-risk populations in light of evidence of waning immunity after the third dose and waves of infection, driven by Omicron and its variants, in some parts of the world. But the recommended age groups differ considerably.
In the United States, for instance, the Food and Drug Administration in late March approved a fourth dose of the Pfizer or Moderna vaccine for anyone over 50 and people over 18 who have gotten a solid organ transplant or have a similar level of immune risk.
Dr. Offit pointed out that Israel offers the fourth vaccine for people 60 and over and the European Medical Association offers it for those over 80. No surprise that confusion over the fourth dose is rampant.
Booster advice
Dr. Offit offered this perspective: People who are immunocompromised could reasonably get a fourth dose, depending on the manner in which they are compromised.
“Someone who has a solid organ transplant is not the same as someone who is getting a monoclonal antibody for their rheumatoid arthritis,” Dr. Offit said, adding that people could also make a reasonable argument for the fourth dose if they are over 65 and have multiple comorbidities.
“I’m over 65,” Dr. Offit said. “I’m generally healthy. I’m not going to get a fourth dose.”
People with multiple comorbidities over age 12 could reasonably get a third dose, he said. “For everybody else – healthy people less than 65 – I would argue this is a two-dose vaccine.”
CHOP, he noted as an example, mandates the vaccine but doesn’t mandate three doses and he says that’s not unusual for hospital systems.
“How many lives are you really saving with that fourth dose? If you really want to have an effect on this pandemic, vaccinate the unvaccinated,” Dr. Offit said.
Focus on the memory cells
Dr. Offit wrote in the editorial: “Arguably, the most disappointing error surrounding the use of COVID-19 vaccines was the labeling of mild illnesses or asymptomatic infections after vaccination as ‘breakthroughs.’ As is true for all mucosal vaccines, the goal is to protect against serious illness – to keep people out of the hospital, intensive care unit, and morgue. The term ‘breakthrough,’ which implies failure, created unrealistic expectations and led to the adoption of a zero-tolerance strategy for this virus.”
Dr. Offit said that the focus should be on the memory cells, not the neutralizing antibodies.
Regarding mRNA vaccines, Dr. Offit said “the surprise of this vaccine – it surprised me and other vaccine researchers – is that with these two doses of mRNA separated by 3-4 weeks, you actually appear to have long-lived memory response.
“That’s not the history of vaccines. If you look at the inactivated polio vaccine or the inactivated hepatitis A vaccine, you really do need a 4- to 6-month interval between doses to get high frequencies of memory cells. That doesn’t appear to be the case here. It looks like two doses given close together do just that. Memory cells last for years if not, sometimes, decades.”
Neutralizing antibodies, on the other hand, protect against mild illness and their effectiveness wanes after months.
“At some point we are going to have to get used to mild illness,” Dr. Offit said.
The Centers for Disease Control and Prevention must now determine who will benefit most from booster dosing and educate the public about the limits of mucosal vaccines, Dr. Offit wrote in the editorial.
“Otherwise, a zero-tolerance strategy for mild or asymptomatic infection, which can be implemented only with frequent booster doses, will continue to mislead the public about what COVID-19 vaccines can and cannot do.”
The work was funded by the Ivan and Francesca Berkowitz Family Living Laboratory Collaboration at Harvard Medical School and Clalit Research Institute.
A version of this article first appeared on Medscape.com.
A fourth dose of the Pfizer-BioNTech vaccine is effective in reducing the short-term risk for COVID-19 infection, hospitalization, and death in people who got a third dose at least 4 months before, a large study shows.
However, Paul Offit, MD, author of an editorial accompanying the study, told this news organization, “I would argue, without fear of contradiction, that this is going to have no impact on this pandemic.”
“We are still in the midst of a zero-tolerance policy for this virus. We don’t accept mild illness and if we’re not going to accept mild illness, we think we have to boost it away, which would mean probably about two doses every year. That’s not a reasonable public health strategy,” said Dr. Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia.
Booster confusion
Results of the research out of Israel, published in the New England Journal of Medicine, make a case for a fourth booster for people 60 and over.
Researchers, led by Ori Magen, MD, Clalit Research Institute, innovation division, Clalit Health Services, Tel Aviv, analyzed data comparing 182,122 matched pairs recorded by the largest health care organization in Israel from Jan. 3 to Feb. 18, 2022. With more than 4.7 million members, Clalit Health Services covers more than half of the population of Israel.
The researchers compared outcomes in people 60 or older (average age, 72 years) who got a fourth dose with outcomes in those who had only a third dose. They individually matched people from the two groups, considering factors such as age, health status, and ethnicity.
Relative vaccine effectiveness in days 7-30 after the fourth dose was estimated to be 45% (95% confidence interval, 44%-47%) against confirmed SARS-CoV-2 infection, 55% (95% CI, 53%-58%) against symptomatic COVID-19, 68% (95% CI, 59%-74%) against hospitalization, 62% (95% CI, 50%-74%) against severe COVID, and 74% (95% CI, 50%-90%) against COVID-related death.
Several countries, including the United States, have begun offering a fourth vaccine dose for higher-risk populations in light of evidence of waning immunity after the third dose and waves of infection, driven by Omicron and its variants, in some parts of the world. But the recommended age groups differ considerably.
In the United States, for instance, the Food and Drug Administration in late March approved a fourth dose of the Pfizer or Moderna vaccine for anyone over 50 and people over 18 who have gotten a solid organ transplant or have a similar level of immune risk.
Dr. Offit pointed out that Israel offers the fourth vaccine for people 60 and over and the European Medical Association offers it for those over 80. No surprise that confusion over the fourth dose is rampant.
Booster advice
Dr. Offit offered this perspective: People who are immunocompromised could reasonably get a fourth dose, depending on the manner in which they are compromised.
“Someone who has a solid organ transplant is not the same as someone who is getting a monoclonal antibody for their rheumatoid arthritis,” Dr. Offit said, adding that people could also make a reasonable argument for the fourth dose if they are over 65 and have multiple comorbidities.
“I’m over 65,” Dr. Offit said. “I’m generally healthy. I’m not going to get a fourth dose.”
People with multiple comorbidities over age 12 could reasonably get a third dose, he said. “For everybody else – healthy people less than 65 – I would argue this is a two-dose vaccine.”
CHOP, he noted as an example, mandates the vaccine but doesn’t mandate three doses and he says that’s not unusual for hospital systems.
“How many lives are you really saving with that fourth dose? If you really want to have an effect on this pandemic, vaccinate the unvaccinated,” Dr. Offit said.
Focus on the memory cells
Dr. Offit wrote in the editorial: “Arguably, the most disappointing error surrounding the use of COVID-19 vaccines was the labeling of mild illnesses or asymptomatic infections after vaccination as ‘breakthroughs.’ As is true for all mucosal vaccines, the goal is to protect against serious illness – to keep people out of the hospital, intensive care unit, and morgue. The term ‘breakthrough,’ which implies failure, created unrealistic expectations and led to the adoption of a zero-tolerance strategy for this virus.”
Dr. Offit said that the focus should be on the memory cells, not the neutralizing antibodies.
Regarding mRNA vaccines, Dr. Offit said “the surprise of this vaccine – it surprised me and other vaccine researchers – is that with these two doses of mRNA separated by 3-4 weeks, you actually appear to have long-lived memory response.
“That’s not the history of vaccines. If you look at the inactivated polio vaccine or the inactivated hepatitis A vaccine, you really do need a 4- to 6-month interval between doses to get high frequencies of memory cells. That doesn’t appear to be the case here. It looks like two doses given close together do just that. Memory cells last for years if not, sometimes, decades.”
Neutralizing antibodies, on the other hand, protect against mild illness and their effectiveness wanes after months.
“At some point we are going to have to get used to mild illness,” Dr. Offit said.
The Centers for Disease Control and Prevention must now determine who will benefit most from booster dosing and educate the public about the limits of mucosal vaccines, Dr. Offit wrote in the editorial.
“Otherwise, a zero-tolerance strategy for mild or asymptomatic infection, which can be implemented only with frequent booster doses, will continue to mislead the public about what COVID-19 vaccines can and cannot do.”
The work was funded by the Ivan and Francesca Berkowitz Family Living Laboratory Collaboration at Harvard Medical School and Clalit Research Institute.
A version of this article first appeared on Medscape.com.
A fourth dose of the Pfizer-BioNTech vaccine is effective in reducing the short-term risk for COVID-19 infection, hospitalization, and death in people who got a third dose at least 4 months before, a large study shows.
However, Paul Offit, MD, author of an editorial accompanying the study, told this news organization, “I would argue, without fear of contradiction, that this is going to have no impact on this pandemic.”
“We are still in the midst of a zero-tolerance policy for this virus. We don’t accept mild illness and if we’re not going to accept mild illness, we think we have to boost it away, which would mean probably about two doses every year. That’s not a reasonable public health strategy,” said Dr. Offit, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia.
Booster confusion
Results of the research out of Israel, published in the New England Journal of Medicine, make a case for a fourth booster for people 60 and over.
Researchers, led by Ori Magen, MD, Clalit Research Institute, innovation division, Clalit Health Services, Tel Aviv, analyzed data comparing 182,122 matched pairs recorded by the largest health care organization in Israel from Jan. 3 to Feb. 18, 2022. With more than 4.7 million members, Clalit Health Services covers more than half of the population of Israel.
The researchers compared outcomes in people 60 or older (average age, 72 years) who got a fourth dose with outcomes in those who had only a third dose. They individually matched people from the two groups, considering factors such as age, health status, and ethnicity.
Relative vaccine effectiveness in days 7-30 after the fourth dose was estimated to be 45% (95% confidence interval, 44%-47%) against confirmed SARS-CoV-2 infection, 55% (95% CI, 53%-58%) against symptomatic COVID-19, 68% (95% CI, 59%-74%) against hospitalization, 62% (95% CI, 50%-74%) against severe COVID, and 74% (95% CI, 50%-90%) against COVID-related death.
Several countries, including the United States, have begun offering a fourth vaccine dose for higher-risk populations in light of evidence of waning immunity after the third dose and waves of infection, driven by Omicron and its variants, in some parts of the world. But the recommended age groups differ considerably.
In the United States, for instance, the Food and Drug Administration in late March approved a fourth dose of the Pfizer or Moderna vaccine for anyone over 50 and people over 18 who have gotten a solid organ transplant or have a similar level of immune risk.
Dr. Offit pointed out that Israel offers the fourth vaccine for people 60 and over and the European Medical Association offers it for those over 80. No surprise that confusion over the fourth dose is rampant.
Booster advice
Dr. Offit offered this perspective: People who are immunocompromised could reasonably get a fourth dose, depending on the manner in which they are compromised.
“Someone who has a solid organ transplant is not the same as someone who is getting a monoclonal antibody for their rheumatoid arthritis,” Dr. Offit said, adding that people could also make a reasonable argument for the fourth dose if they are over 65 and have multiple comorbidities.
“I’m over 65,” Dr. Offit said. “I’m generally healthy. I’m not going to get a fourth dose.”
People with multiple comorbidities over age 12 could reasonably get a third dose, he said. “For everybody else – healthy people less than 65 – I would argue this is a two-dose vaccine.”
CHOP, he noted as an example, mandates the vaccine but doesn’t mandate three doses and he says that’s not unusual for hospital systems.
“How many lives are you really saving with that fourth dose? If you really want to have an effect on this pandemic, vaccinate the unvaccinated,” Dr. Offit said.
Focus on the memory cells
Dr. Offit wrote in the editorial: “Arguably, the most disappointing error surrounding the use of COVID-19 vaccines was the labeling of mild illnesses or asymptomatic infections after vaccination as ‘breakthroughs.’ As is true for all mucosal vaccines, the goal is to protect against serious illness – to keep people out of the hospital, intensive care unit, and morgue. The term ‘breakthrough,’ which implies failure, created unrealistic expectations and led to the adoption of a zero-tolerance strategy for this virus.”
Dr. Offit said that the focus should be on the memory cells, not the neutralizing antibodies.
Regarding mRNA vaccines, Dr. Offit said “the surprise of this vaccine – it surprised me and other vaccine researchers – is that with these two doses of mRNA separated by 3-4 weeks, you actually appear to have long-lived memory response.
“That’s not the history of vaccines. If you look at the inactivated polio vaccine or the inactivated hepatitis A vaccine, you really do need a 4- to 6-month interval between doses to get high frequencies of memory cells. That doesn’t appear to be the case here. It looks like two doses given close together do just that. Memory cells last for years if not, sometimes, decades.”
Neutralizing antibodies, on the other hand, protect against mild illness and their effectiveness wanes after months.
“At some point we are going to have to get used to mild illness,” Dr. Offit said.
The Centers for Disease Control and Prevention must now determine who will benefit most from booster dosing and educate the public about the limits of mucosal vaccines, Dr. Offit wrote in the editorial.
“Otherwise, a zero-tolerance strategy for mild or asymptomatic infection, which can be implemented only with frequent booster doses, will continue to mislead the public about what COVID-19 vaccines can and cannot do.”
The work was funded by the Ivan and Francesca Berkowitz Family Living Laboratory Collaboration at Harvard Medical School and Clalit Research Institute.
A version of this article first appeared on Medscape.com.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
Woman who faked medical degree practiced for 3 years
Who needs medical degrees anyway?
It’s no secret that doctors make a fair chunk of change. It’s a lucrative profession, but that big fat paycheck is siloed behind long, tough years of medical school and residency. It’s not an easy path doctors walk. Or at least, it’s not supposed to be. Anything’s easy if you’re willing to lie.
That brings us to Sonia, a 31-year-old woman from northern France with a bachelor’s degree in real estate management who wasn’t bringing in enough money for her three children, at least not to her satisfaction. Naturally, the only decision was to forge some diplomas from the University of Strasbourg, as well as a certificate from the French Order of Physicians. Sonia got hired as a general practitioner by using the identities of two doctors who shared her name. She had no experience, had no idea what she was doing, and was wearing a GPS tagging bracelet for an unrelated crime, so she was quickly caught and exposed in October 2021, after, um, 3 years of fake doctoring, according to France Live.
Not to be deterred by this temporary setback, Sonia proceeded to immediately find work as an ophthalmologist, a career that requires more than 10 years of training, continuing her fraudulent medical career until recently, when she was caught again and sentenced to 3 years in prison. She did make 70,000 euros a year as a fake doctor, which isn’t exactly huge money, but certainly not bad either.
We certainly hope she’s learned her lesson about impersonating a doctor, at this point, but maybe she should just go to medical school. If not, northern France might just end up with a new endocrinologist or oncologist floating around in 3 years.
No need to ‘guess what size horse you are’
Is COVID-19 warming up for yet another surge? Maybe. That means it’s also time for the return of its remora-like follower, ivermectin. Our thanks go out to the Tennessee state legislature for bringing the proven-to-be-ineffective treatment for COVID back into our hearts and minds and emergency rooms.
Both the state House and Senate have approved a bill that allows pharmacists to dispense the antiparasitic drug without a prescription while shielding them “from any liability that could arise from dispensing ivermectin,” Nashville Public Radio reported.
The drug’s manufacturer, Merck, said over a year ago that there is “no scientific basis for a potential therapeutic effect against COVID-19 from preclinical studies … and a concerning lack of safety data.” More recently, a study published in the New England Journal of Medicine showed that ivermectin treatment had no important benefits in patients with COVID.
Last week, the bill’s Senate sponsor, Frank Niceley of Strawberry Plains, said that it was all about safety, as he explained to NPR station WPLN: “It’s a lot safer to go to your pharmacist and let him tell you how much ivermectin to take than it is to go to the co-op and guess what size horse you are.”
And on that note, here are a few more items of business that just might end up on the legislature’s calendar:
- Horses will be allowed to “share” their unused ivermectin with humans and other mammals.
- An apple a day not only keeps the doctor away, but the IRS and the FDA as well.
- Colon cleansing is more fun than humans should be allowed to have.
- TikTok videos qualify as CME.
Who needs medical degrees anyway?
It’s no secret that doctors make a fair chunk of change. It’s a lucrative profession, but that big fat paycheck is siloed behind long, tough years of medical school and residency. It’s not an easy path doctors walk. Or at least, it’s not supposed to be. Anything’s easy if you’re willing to lie.
That brings us to Sonia, a 31-year-old woman from northern France with a bachelor’s degree in real estate management who wasn’t bringing in enough money for her three children, at least not to her satisfaction. Naturally, the only decision was to forge some diplomas from the University of Strasbourg, as well as a certificate from the French Order of Physicians. Sonia got hired as a general practitioner by using the identities of two doctors who shared her name. She had no experience, had no idea what she was doing, and was wearing a GPS tagging bracelet for an unrelated crime, so she was quickly caught and exposed in October 2021, after, um, 3 years of fake doctoring, according to France Live.
Not to be deterred by this temporary setback, Sonia proceeded to immediately find work as an ophthalmologist, a career that requires more than 10 years of training, continuing her fraudulent medical career until recently, when she was caught again and sentenced to 3 years in prison. She did make 70,000 euros a year as a fake doctor, which isn’t exactly huge money, but certainly not bad either.
We certainly hope she’s learned her lesson about impersonating a doctor, at this point, but maybe she should just go to medical school. If not, northern France might just end up with a new endocrinologist or oncologist floating around in 3 years.
Speak louder, I can’t see you
With the introduction of FaceTime and the pandemic pushing work and social events to Zoom, video calls have become ubiquitous. Along the way, however, we’ve had to learn to adjust to technical difficulties. Often by yelling at the screen when the video quality is disrupted. Waving our hands and arms, speaking louder. Sound like you?
Well, a new study published in Royal Society Open Science shows that it sounds like a lot of us.
James Trujillo of the Max Planck Institute for Psycholinguistics in Nijmegen, the Netherlands, who was lead author of the paper, said on Eurekalert that “previous research has shown that speech and gestures are linked, but ours is the first to look into how visuals impact our behavior in those fields.”
He and his associates set up 40 participants in separate rooms to have conversations in pairs over a video chat. Over the course of 40 minutes, the video quality started to deteriorate from clear to extremely blurry. When the video quality was affected, participants started with gestures but as the quality continued to lessen the gestures increased and so did the decibels of their voices.
Even when the participants could barely see each other, they still gestured and their voices were even louder, positively supporting the idea that gestures and speech are a dynamically linked when it comes to communication. Even on regular phone calls, when we can’t see each other at all, people make small movements and gestures, Mr. Trujillo said.
So, the next time the Wifi is terrible and your video calls keep cutting out, don’t worry about looking foolish screaming at the computer. We’ve all been there.
Seek a doctor if standing at attention for more than 4 hours
Imbrochável. In Brazil, it means “unfloppable” or “flaccid proof.” It’s also a word that Brazilian president Jair Bolsonaro likes to use when referring to himself. Gives you a good idea of what he’s all about. Imagine his embarrassment when news recently broke about more than 30,000 pills of Viagra that had been secretly distributed to the Brazilian military.
The military offered a simple and plausible explanation: The Viagra had been prescribed to treat pulmonary hypertension. Fair, but when a Brazilian newspaper dug a little deeper, they found that this was not the case. The Viagra was, in general, being used for its, shall we say, traditional purpose.
Many Brazilians reacted poorly to the news that their tax dollars were being used to provide Brazilian soldiers with downstairs assistance, with the standard associated furor on social media. A rival politician, Ciro Gomes, who is planning on challenging the president in an upcoming election, had perhaps the best remark on the situation: “Unless they’re able to prove they’re developing some kind of secret weapon – capable of revolutionizing the international arms industry – it’ll be tough to justify the purchase of 35,000 units of a erectile dysfunction drug.”
Hmm, secret weapon. Well, a certain Russian fellow has made a bit of a thrust into world affairs recently. Does anyone know if Putin is sitting on a big Viagra stash?
Who needs medical degrees anyway?
It’s no secret that doctors make a fair chunk of change. It’s a lucrative profession, but that big fat paycheck is siloed behind long, tough years of medical school and residency. It’s not an easy path doctors walk. Or at least, it’s not supposed to be. Anything’s easy if you’re willing to lie.
That brings us to Sonia, a 31-year-old woman from northern France with a bachelor’s degree in real estate management who wasn’t bringing in enough money for her three children, at least not to her satisfaction. Naturally, the only decision was to forge some diplomas from the University of Strasbourg, as well as a certificate from the French Order of Physicians. Sonia got hired as a general practitioner by using the identities of two doctors who shared her name. She had no experience, had no idea what she was doing, and was wearing a GPS tagging bracelet for an unrelated crime, so she was quickly caught and exposed in October 2021, after, um, 3 years of fake doctoring, according to France Live.
Not to be deterred by this temporary setback, Sonia proceeded to immediately find work as an ophthalmologist, a career that requires more than 10 years of training, continuing her fraudulent medical career until recently, when she was caught again and sentenced to 3 years in prison. She did make 70,000 euros a year as a fake doctor, which isn’t exactly huge money, but certainly not bad either.
We certainly hope she’s learned her lesson about impersonating a doctor, at this point, but maybe she should just go to medical school. If not, northern France might just end up with a new endocrinologist or oncologist floating around in 3 years.
No need to ‘guess what size horse you are’
Is COVID-19 warming up for yet another surge? Maybe. That means it’s also time for the return of its remora-like follower, ivermectin. Our thanks go out to the Tennessee state legislature for bringing the proven-to-be-ineffective treatment for COVID back into our hearts and minds and emergency rooms.
Both the state House and Senate have approved a bill that allows pharmacists to dispense the antiparasitic drug without a prescription while shielding them “from any liability that could arise from dispensing ivermectin,” Nashville Public Radio reported.
The drug’s manufacturer, Merck, said over a year ago that there is “no scientific basis for a potential therapeutic effect against COVID-19 from preclinical studies … and a concerning lack of safety data.” More recently, a study published in the New England Journal of Medicine showed that ivermectin treatment had no important benefits in patients with COVID.
Last week, the bill’s Senate sponsor, Frank Niceley of Strawberry Plains, said that it was all about safety, as he explained to NPR station WPLN: “It’s a lot safer to go to your pharmacist and let him tell you how much ivermectin to take than it is to go to the co-op and guess what size horse you are.”
And on that note, here are a few more items of business that just might end up on the legislature’s calendar:
- Horses will be allowed to “share” their unused ivermectin with humans and other mammals.
- An apple a day not only keeps the doctor away, but the IRS and the FDA as well.
- Colon cleansing is more fun than humans should be allowed to have.
- TikTok videos qualify as CME.
Who needs medical degrees anyway?
It’s no secret that doctors make a fair chunk of change. It’s a lucrative profession, but that big fat paycheck is siloed behind long, tough years of medical school and residency. It’s not an easy path doctors walk. Or at least, it’s not supposed to be. Anything’s easy if you’re willing to lie.
That brings us to Sonia, a 31-year-old woman from northern France with a bachelor’s degree in real estate management who wasn’t bringing in enough money for her three children, at least not to her satisfaction. Naturally, the only decision was to forge some diplomas from the University of Strasbourg, as well as a certificate from the French Order of Physicians. Sonia got hired as a general practitioner by using the identities of two doctors who shared her name. She had no experience, had no idea what she was doing, and was wearing a GPS tagging bracelet for an unrelated crime, so she was quickly caught and exposed in October 2021, after, um, 3 years of fake doctoring, according to France Live.
Not to be deterred by this temporary setback, Sonia proceeded to immediately find work as an ophthalmologist, a career that requires more than 10 years of training, continuing her fraudulent medical career until recently, when she was caught again and sentenced to 3 years in prison. She did make 70,000 euros a year as a fake doctor, which isn’t exactly huge money, but certainly not bad either.
We certainly hope she’s learned her lesson about impersonating a doctor, at this point, but maybe she should just go to medical school. If not, northern France might just end up with a new endocrinologist or oncologist floating around in 3 years.
Speak louder, I can’t see you
With the introduction of FaceTime and the pandemic pushing work and social events to Zoom, video calls have become ubiquitous. Along the way, however, we’ve had to learn to adjust to technical difficulties. Often by yelling at the screen when the video quality is disrupted. Waving our hands and arms, speaking louder. Sound like you?
Well, a new study published in Royal Society Open Science shows that it sounds like a lot of us.
James Trujillo of the Max Planck Institute for Psycholinguistics in Nijmegen, the Netherlands, who was lead author of the paper, said on Eurekalert that “previous research has shown that speech and gestures are linked, but ours is the first to look into how visuals impact our behavior in those fields.”
He and his associates set up 40 participants in separate rooms to have conversations in pairs over a video chat. Over the course of 40 minutes, the video quality started to deteriorate from clear to extremely blurry. When the video quality was affected, participants started with gestures but as the quality continued to lessen the gestures increased and so did the decibels of their voices.
Even when the participants could barely see each other, they still gestured and their voices were even louder, positively supporting the idea that gestures and speech are a dynamically linked when it comes to communication. Even on regular phone calls, when we can’t see each other at all, people make small movements and gestures, Mr. Trujillo said.
So, the next time the Wifi is terrible and your video calls keep cutting out, don’t worry about looking foolish screaming at the computer. We’ve all been there.
Seek a doctor if standing at attention for more than 4 hours
Imbrochável. In Brazil, it means “unfloppable” or “flaccid proof.” It’s also a word that Brazilian president Jair Bolsonaro likes to use when referring to himself. Gives you a good idea of what he’s all about. Imagine his embarrassment when news recently broke about more than 30,000 pills of Viagra that had been secretly distributed to the Brazilian military.
The military offered a simple and plausible explanation: The Viagra had been prescribed to treat pulmonary hypertension. Fair, but when a Brazilian newspaper dug a little deeper, they found that this was not the case. The Viagra was, in general, being used for its, shall we say, traditional purpose.
Many Brazilians reacted poorly to the news that their tax dollars were being used to provide Brazilian soldiers with downstairs assistance, with the standard associated furor on social media. A rival politician, Ciro Gomes, who is planning on challenging the president in an upcoming election, had perhaps the best remark on the situation: “Unless they’re able to prove they’re developing some kind of secret weapon – capable of revolutionizing the international arms industry – it’ll be tough to justify the purchase of 35,000 units of a erectile dysfunction drug.”
Hmm, secret weapon. Well, a certain Russian fellow has made a bit of a thrust into world affairs recently. Does anyone know if Putin is sitting on a big Viagra stash?
Who needs medical degrees anyway?
It’s no secret that doctors make a fair chunk of change. It’s a lucrative profession, but that big fat paycheck is siloed behind long, tough years of medical school and residency. It’s not an easy path doctors walk. Or at least, it’s not supposed to be. Anything’s easy if you’re willing to lie.
That brings us to Sonia, a 31-year-old woman from northern France with a bachelor’s degree in real estate management who wasn’t bringing in enough money for her three children, at least not to her satisfaction. Naturally, the only decision was to forge some diplomas from the University of Strasbourg, as well as a certificate from the French Order of Physicians. Sonia got hired as a general practitioner by using the identities of two doctors who shared her name. She had no experience, had no idea what she was doing, and was wearing a GPS tagging bracelet for an unrelated crime, so she was quickly caught and exposed in October 2021, after, um, 3 years of fake doctoring, according to France Live.
Not to be deterred by this temporary setback, Sonia proceeded to immediately find work as an ophthalmologist, a career that requires more than 10 years of training, continuing her fraudulent medical career until recently, when she was caught again and sentenced to 3 years in prison. She did make 70,000 euros a year as a fake doctor, which isn’t exactly huge money, but certainly not bad either.
We certainly hope she’s learned her lesson about impersonating a doctor, at this point, but maybe she should just go to medical school. If not, northern France might just end up with a new endocrinologist or oncologist floating around in 3 years.
No need to ‘guess what size horse you are’
Is COVID-19 warming up for yet another surge? Maybe. That means it’s also time for the return of its remora-like follower, ivermectin. Our thanks go out to the Tennessee state legislature for bringing the proven-to-be-ineffective treatment for COVID back into our hearts and minds and emergency rooms.
Both the state House and Senate have approved a bill that allows pharmacists to dispense the antiparasitic drug without a prescription while shielding them “from any liability that could arise from dispensing ivermectin,” Nashville Public Radio reported.
The drug’s manufacturer, Merck, said over a year ago that there is “no scientific basis for a potential therapeutic effect against COVID-19 from preclinical studies … and a concerning lack of safety data.” More recently, a study published in the New England Journal of Medicine showed that ivermectin treatment had no important benefits in patients with COVID.
Last week, the bill’s Senate sponsor, Frank Niceley of Strawberry Plains, said that it was all about safety, as he explained to NPR station WPLN: “It’s a lot safer to go to your pharmacist and let him tell you how much ivermectin to take than it is to go to the co-op and guess what size horse you are.”
And on that note, here are a few more items of business that just might end up on the legislature’s calendar:
- Horses will be allowed to “share” their unused ivermectin with humans and other mammals.
- An apple a day not only keeps the doctor away, but the IRS and the FDA as well.
- Colon cleansing is more fun than humans should be allowed to have.
- TikTok videos qualify as CME.
Who needs medical degrees anyway?
It’s no secret that doctors make a fair chunk of change. It’s a lucrative profession, but that big fat paycheck is siloed behind long, tough years of medical school and residency. It’s not an easy path doctors walk. Or at least, it’s not supposed to be. Anything’s easy if you’re willing to lie.
That brings us to Sonia, a 31-year-old woman from northern France with a bachelor’s degree in real estate management who wasn’t bringing in enough money for her three children, at least not to her satisfaction. Naturally, the only decision was to forge some diplomas from the University of Strasbourg, as well as a certificate from the French Order of Physicians. Sonia got hired as a general practitioner by using the identities of two doctors who shared her name. She had no experience, had no idea what she was doing, and was wearing a GPS tagging bracelet for an unrelated crime, so she was quickly caught and exposed in October 2021, after, um, 3 years of fake doctoring, according to France Live.
Not to be deterred by this temporary setback, Sonia proceeded to immediately find work as an ophthalmologist, a career that requires more than 10 years of training, continuing her fraudulent medical career until recently, when she was caught again and sentenced to 3 years in prison. She did make 70,000 euros a year as a fake doctor, which isn’t exactly huge money, but certainly not bad either.
We certainly hope she’s learned her lesson about impersonating a doctor, at this point, but maybe she should just go to medical school. If not, northern France might just end up with a new endocrinologist or oncologist floating around in 3 years.
Speak louder, I can’t see you
With the introduction of FaceTime and the pandemic pushing work and social events to Zoom, video calls have become ubiquitous. Along the way, however, we’ve had to learn to adjust to technical difficulties. Often by yelling at the screen when the video quality is disrupted. Waving our hands and arms, speaking louder. Sound like you?
Well, a new study published in Royal Society Open Science shows that it sounds like a lot of us.
James Trujillo of the Max Planck Institute for Psycholinguistics in Nijmegen, the Netherlands, who was lead author of the paper, said on Eurekalert that “previous research has shown that speech and gestures are linked, but ours is the first to look into how visuals impact our behavior in those fields.”
He and his associates set up 40 participants in separate rooms to have conversations in pairs over a video chat. Over the course of 40 minutes, the video quality started to deteriorate from clear to extremely blurry. When the video quality was affected, participants started with gestures but as the quality continued to lessen the gestures increased and so did the decibels of their voices.
Even when the participants could barely see each other, they still gestured and their voices were even louder, positively supporting the idea that gestures and speech are a dynamically linked when it comes to communication. Even on regular phone calls, when we can’t see each other at all, people make small movements and gestures, Mr. Trujillo said.
So, the next time the Wifi is terrible and your video calls keep cutting out, don’t worry about looking foolish screaming at the computer. We’ve all been there.
Seek a doctor if standing at attention for more than 4 hours
Imbrochável. In Brazil, it means “unfloppable” or “flaccid proof.” It’s also a word that Brazilian president Jair Bolsonaro likes to use when referring to himself. Gives you a good idea of what he’s all about. Imagine his embarrassment when news recently broke about more than 30,000 pills of Viagra that had been secretly distributed to the Brazilian military.
The military offered a simple and plausible explanation: The Viagra had been prescribed to treat pulmonary hypertension. Fair, but when a Brazilian newspaper dug a little deeper, they found that this was not the case. The Viagra was, in general, being used for its, shall we say, traditional purpose.
Many Brazilians reacted poorly to the news that their tax dollars were being used to provide Brazilian soldiers with downstairs assistance, with the standard associated furor on social media. A rival politician, Ciro Gomes, who is planning on challenging the president in an upcoming election, had perhaps the best remark on the situation: “Unless they’re able to prove they’re developing some kind of secret weapon – capable of revolutionizing the international arms industry – it’ll be tough to justify the purchase of 35,000 units of a erectile dysfunction drug.”
Hmm, secret weapon. Well, a certain Russian fellow has made a bit of a thrust into world affairs recently. Does anyone know if Putin is sitting on a big Viagra stash?
Global incidence, deaths from CRC doubled over past 3 decades
, according to a new analysis of 204 countries.
However, trends in CRC incidence and deaths varied by age, region, and sex. Investigators expressed particular concern over the rising incidence rates among people younger than 50 and those living in low and middle sociodemographic index countries in Asia and Africa.
“These results provide comprehensive and comparable estimates that can inform efforts for equitable colorectal cancer control worldwide,” the authors write. However, “further research is required to understand the causes of the colorectal cancer burden in younger adults (aged less than 50 years) and the main risk factors, including obesity, physical inactivity, alcohol consumption, smoking, and an altered gut microbiome, that might have led to the rise in the colorectal cancer burden.”
The study was published online in the Lancet Gastroenterology and Hepatology.
CRC is the third leading cause of cancer deaths worldwide, but data on incidence and mortality by location, age, and sex remain less clear.
In the current Global Burden of Diseases, Injuries and Risk Factors Study, researchers evaluated age, sex, and geography-level estimates of CRC incidence, deaths, and disability-adjusted life-years (DALYs) from 204 countries between 1990 and 2019.
The authors found that cases of CRC increased by almost 2.6-fold over the 30-year study period, from 842,098 to 2.17 million. Deaths from CRC increased at a similar but slightly lower rate – rising 2.1-fold over the same period, from 518,126 to 1.09 million. DALYs also nearly doubled, going from 12.4 million in 1990 to 24.3 million in 2019.
In addition, the global age-standardized incidence rate increased from 22.2 to 26.7 per 100,000.
Overall, the age-standardized mortality rate decreased slightly, from 14.3 to 13.7 per 100,000; however, only high-middle and high sociodemographic index regions experienced a decrease; low and middle sociodemographic index regions experienced an increase. The age-standardized DALY rate also declined overall, from 308.5 per 100,000 in 1900 to 295.5 per 100,000 in 2019.
The authors further broke down CRC incidence and deaths by age, region, and sex.
Over the study period, males demonstrated greater increases in CRC incidence, deaths, and DALYs, compared with females. In 2019, the age-standardized CRC incidence rate was 1.5 times higher in males (33.1 vs 21.2 per 100,000), as was the age-standardized mortality rate (16.6 vs. 11.2 per 100,000). The age-standardized DALY rate showed a similar trend by sex – 360 versus 238 per 100,000 in males versus females.
Trends varied by age as well. CRC incidence rates increased the most in people aged 85 and older, followed by those between 20 and 49 years, while rates decreased for those between 50 and 80 years in high sociodemographic index countries.
Geography mattered too. China, the United States, and Japan demonstrated the highest number of new CRC cases across all ages and for both sexes in 2019 – 607,900 in China, 227,242 in the United States, and 160,211 in Japan.
In terms of mortality, China, the United States, and India had the highest CRC death counts: 261,777 in China, 84,026 in the United States, and 79,098 in India.
When it comes to age-standardized incidence rates, Taiwan, Monaco, and Andorra were at the top: Taiwan with 62 per 100,000 cases, Monaco with 60.7 per 100,000, and Andorra with 56.6 per 100,000.
On the other hand, Somalia, Niger, and Bangladesh had the lowest age-standardized incidence rates, 5 per 100,000 in Somalia and 5.6 per 100,000 in Niger and Bangladesh.
The highest age-standardized mortality rates occurred in Greenland, Brunei, and Hungary: 31.4 per 100,000 in Greenland, 30.3 per 100,000 in Brunei, and 28.6 per 100,000 in Hungary.
The relative contribution of different risk factors also varied by region. For example, in sub-Saharan Africa and lower-income countries in Asia, diets low in calcium and milk were the main CRC risk factors. In contrast, smoking and alcohol consumption were the main risk factors driving CRC in high-income regions.
Still, the reasons underlying some of these trends – such as the increasing incidence of CRC in patients under the age of 50 – remain uncertain. One possible explanation for this trend, the researchers point out, is the birth cohort effect, which suggests that those born in the second half of the 20th century are increasingly exposed to potentially modifiable risk factors, such as an unhealthy diet, obesity, and sedentary lifestyles.
Overall, the authors note that the data generated in this study provide an important resource for both patients and oncologists about current trends in incidence and mortality and where gaps in preventive measures may exist.
In particular, the authors conclude that “public health interventions for colorectal cancer awareness, screening, and prevention through containment of modifiable risk factors such as alcohol, smoking, unhealthy diet ... and obesity are key to stemming the tide of colorectal cancer worldwide.”
The study was funded by the Bill & Melinda Gates Foundation. The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, according to a new analysis of 204 countries.
However, trends in CRC incidence and deaths varied by age, region, and sex. Investigators expressed particular concern over the rising incidence rates among people younger than 50 and those living in low and middle sociodemographic index countries in Asia and Africa.
“These results provide comprehensive and comparable estimates that can inform efforts for equitable colorectal cancer control worldwide,” the authors write. However, “further research is required to understand the causes of the colorectal cancer burden in younger adults (aged less than 50 years) and the main risk factors, including obesity, physical inactivity, alcohol consumption, smoking, and an altered gut microbiome, that might have led to the rise in the colorectal cancer burden.”
The study was published online in the Lancet Gastroenterology and Hepatology.
CRC is the third leading cause of cancer deaths worldwide, but data on incidence and mortality by location, age, and sex remain less clear.
In the current Global Burden of Diseases, Injuries and Risk Factors Study, researchers evaluated age, sex, and geography-level estimates of CRC incidence, deaths, and disability-adjusted life-years (DALYs) from 204 countries between 1990 and 2019.
The authors found that cases of CRC increased by almost 2.6-fold over the 30-year study period, from 842,098 to 2.17 million. Deaths from CRC increased at a similar but slightly lower rate – rising 2.1-fold over the same period, from 518,126 to 1.09 million. DALYs also nearly doubled, going from 12.4 million in 1990 to 24.3 million in 2019.
In addition, the global age-standardized incidence rate increased from 22.2 to 26.7 per 100,000.
Overall, the age-standardized mortality rate decreased slightly, from 14.3 to 13.7 per 100,000; however, only high-middle and high sociodemographic index regions experienced a decrease; low and middle sociodemographic index regions experienced an increase. The age-standardized DALY rate also declined overall, from 308.5 per 100,000 in 1900 to 295.5 per 100,000 in 2019.
The authors further broke down CRC incidence and deaths by age, region, and sex.
Over the study period, males demonstrated greater increases in CRC incidence, deaths, and DALYs, compared with females. In 2019, the age-standardized CRC incidence rate was 1.5 times higher in males (33.1 vs 21.2 per 100,000), as was the age-standardized mortality rate (16.6 vs. 11.2 per 100,000). The age-standardized DALY rate showed a similar trend by sex – 360 versus 238 per 100,000 in males versus females.
Trends varied by age as well. CRC incidence rates increased the most in people aged 85 and older, followed by those between 20 and 49 years, while rates decreased for those between 50 and 80 years in high sociodemographic index countries.
Geography mattered too. China, the United States, and Japan demonstrated the highest number of new CRC cases across all ages and for both sexes in 2019 – 607,900 in China, 227,242 in the United States, and 160,211 in Japan.
In terms of mortality, China, the United States, and India had the highest CRC death counts: 261,777 in China, 84,026 in the United States, and 79,098 in India.
When it comes to age-standardized incidence rates, Taiwan, Monaco, and Andorra were at the top: Taiwan with 62 per 100,000 cases, Monaco with 60.7 per 100,000, and Andorra with 56.6 per 100,000.
On the other hand, Somalia, Niger, and Bangladesh had the lowest age-standardized incidence rates, 5 per 100,000 in Somalia and 5.6 per 100,000 in Niger and Bangladesh.
The highest age-standardized mortality rates occurred in Greenland, Brunei, and Hungary: 31.4 per 100,000 in Greenland, 30.3 per 100,000 in Brunei, and 28.6 per 100,000 in Hungary.
The relative contribution of different risk factors also varied by region. For example, in sub-Saharan Africa and lower-income countries in Asia, diets low in calcium and milk were the main CRC risk factors. In contrast, smoking and alcohol consumption were the main risk factors driving CRC in high-income regions.
Still, the reasons underlying some of these trends – such as the increasing incidence of CRC in patients under the age of 50 – remain uncertain. One possible explanation for this trend, the researchers point out, is the birth cohort effect, which suggests that those born in the second half of the 20th century are increasingly exposed to potentially modifiable risk factors, such as an unhealthy diet, obesity, and sedentary lifestyles.
Overall, the authors note that the data generated in this study provide an important resource for both patients and oncologists about current trends in incidence and mortality and where gaps in preventive measures may exist.
In particular, the authors conclude that “public health interventions for colorectal cancer awareness, screening, and prevention through containment of modifiable risk factors such as alcohol, smoking, unhealthy diet ... and obesity are key to stemming the tide of colorectal cancer worldwide.”
The study was funded by the Bill & Melinda Gates Foundation. The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, according to a new analysis of 204 countries.
However, trends in CRC incidence and deaths varied by age, region, and sex. Investigators expressed particular concern over the rising incidence rates among people younger than 50 and those living in low and middle sociodemographic index countries in Asia and Africa.
“These results provide comprehensive and comparable estimates that can inform efforts for equitable colorectal cancer control worldwide,” the authors write. However, “further research is required to understand the causes of the colorectal cancer burden in younger adults (aged less than 50 years) and the main risk factors, including obesity, physical inactivity, alcohol consumption, smoking, and an altered gut microbiome, that might have led to the rise in the colorectal cancer burden.”
The study was published online in the Lancet Gastroenterology and Hepatology.
CRC is the third leading cause of cancer deaths worldwide, but data on incidence and mortality by location, age, and sex remain less clear.
In the current Global Burden of Diseases, Injuries and Risk Factors Study, researchers evaluated age, sex, and geography-level estimates of CRC incidence, deaths, and disability-adjusted life-years (DALYs) from 204 countries between 1990 and 2019.
The authors found that cases of CRC increased by almost 2.6-fold over the 30-year study period, from 842,098 to 2.17 million. Deaths from CRC increased at a similar but slightly lower rate – rising 2.1-fold over the same period, from 518,126 to 1.09 million. DALYs also nearly doubled, going from 12.4 million in 1990 to 24.3 million in 2019.
In addition, the global age-standardized incidence rate increased from 22.2 to 26.7 per 100,000.
Overall, the age-standardized mortality rate decreased slightly, from 14.3 to 13.7 per 100,000; however, only high-middle and high sociodemographic index regions experienced a decrease; low and middle sociodemographic index regions experienced an increase. The age-standardized DALY rate also declined overall, from 308.5 per 100,000 in 1900 to 295.5 per 100,000 in 2019.
The authors further broke down CRC incidence and deaths by age, region, and sex.
Over the study period, males demonstrated greater increases in CRC incidence, deaths, and DALYs, compared with females. In 2019, the age-standardized CRC incidence rate was 1.5 times higher in males (33.1 vs 21.2 per 100,000), as was the age-standardized mortality rate (16.6 vs. 11.2 per 100,000). The age-standardized DALY rate showed a similar trend by sex – 360 versus 238 per 100,000 in males versus females.
Trends varied by age as well. CRC incidence rates increased the most in people aged 85 and older, followed by those between 20 and 49 years, while rates decreased for those between 50 and 80 years in high sociodemographic index countries.
Geography mattered too. China, the United States, and Japan demonstrated the highest number of new CRC cases across all ages and for both sexes in 2019 – 607,900 in China, 227,242 in the United States, and 160,211 in Japan.
In terms of mortality, China, the United States, and India had the highest CRC death counts: 261,777 in China, 84,026 in the United States, and 79,098 in India.
When it comes to age-standardized incidence rates, Taiwan, Monaco, and Andorra were at the top: Taiwan with 62 per 100,000 cases, Monaco with 60.7 per 100,000, and Andorra with 56.6 per 100,000.
On the other hand, Somalia, Niger, and Bangladesh had the lowest age-standardized incidence rates, 5 per 100,000 in Somalia and 5.6 per 100,000 in Niger and Bangladesh.
The highest age-standardized mortality rates occurred in Greenland, Brunei, and Hungary: 31.4 per 100,000 in Greenland, 30.3 per 100,000 in Brunei, and 28.6 per 100,000 in Hungary.
The relative contribution of different risk factors also varied by region. For example, in sub-Saharan Africa and lower-income countries in Asia, diets low in calcium and milk were the main CRC risk factors. In contrast, smoking and alcohol consumption were the main risk factors driving CRC in high-income regions.
Still, the reasons underlying some of these trends – such as the increasing incidence of CRC in patients under the age of 50 – remain uncertain. One possible explanation for this trend, the researchers point out, is the birth cohort effect, which suggests that those born in the second half of the 20th century are increasingly exposed to potentially modifiable risk factors, such as an unhealthy diet, obesity, and sedentary lifestyles.
Overall, the authors note that the data generated in this study provide an important resource for both patients and oncologists about current trends in incidence and mortality and where gaps in preventive measures may exist.
In particular, the authors conclude that “public health interventions for colorectal cancer awareness, screening, and prevention through containment of modifiable risk factors such as alcohol, smoking, unhealthy diet ... and obesity are key to stemming the tide of colorectal cancer worldwide.”
The study was funded by the Bill & Melinda Gates Foundation. The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM THE LANCET GASTROENTEROLOGY AND HEPATOLOGY
Endometriosis: Clinical Diagnosis and Empiric Treatment
Dr. Taylor: Endometriosis is a very common disease. Unfortunately, it's still widely under-recognized. It's estimated that perhaps up to 10% of reproductive age women have endometriosis, yet many are never diagnosed or diagnosed late. The average time that it takes for someone to be diagnosed is about 10 years; that is from the time they have classic symptoms of endometriosis until the time they get a definitive diagnosis and treatment.
I think it's very important that we recognize the clinical features of endometriosis. It's absolutely crucial if we want to shorten the time tom diagnosis. Often patients see multiple physicians before they get an accurate diagnosis. They're often dismissed by their early caregivers who are not very familiar with the disease.
For me, the most important feature is the pelvic pain. To identify endometriosis, I look specifically at the cyclic nature of the pelvic pain, and the progressive nature of the pelvic pain. Endometriosis is by far the most common reason that women have pelvic pain and initially it tends to be cyclic. It often starts as dysmenorrhea (painful periods), however it can progress to the point where pain occurs at times outside of menses. In fact, it can progress to the point where it's painful all the time. However, it almost always starts as dysmennorhea, and progresses.
Pelvic pain that someone had from their first menses on, i.e., from menarche, is less likely to be endometriosis than the pain that progresses and becomes worse or spreads to other times of the menstrual cycle. Endometriosis is a progressive disease, and that's one of the key distinctions in making me think somebody has endometriosis.
Most women with cyclic pelvic pain that gets worse over time, cyclic progressive pelvic pain, will have endometriosis. Those are the key features I look for.
It is also very important to recognize that endometriosis can have effects outside of the reproductive tract, can cause systemic inflammation, and impact other organ systems. Bowel and bladder dysfunction are very common. If that is cyclic and coincides with the pelvic pain, it’s very likely to be secondary to endometriosis. It's important not to get distracted or mislead into making other diagnoses.
What are some of the common symptoms and how does that impact your diagnosis evaluation?
Dr. Taylor: The most common symptom we see is that cyclic pelvic pain I just discussed. Pain, often starting as dysmenorrhea, can go on to include pain outside of the time of menses and become more than just dysmenorrhea- pain in other areas. The other common symptom is infertility. Many women with endometriosis do not have severe pain or may not have pain at all, but first present when they have trouble conceiving.
Endometriosis may be the cause of infertility. Sometimes we recognize that it's endometriosis when we do a physical exam or an ultrasound and find an endometrioma. Cyclic pelvic pain is the classic symptom we look for, and infertility is another key symptom that we shouldn't forget.
Can you talk a little bit about empiric treatment, primarily what that means and how prevalent it is in your current practice?
Dr. Taylor: I think one of the problems we have today with the treatment of endometriosis is that it doesn't get recognized and doesn't get treated right away. When we talk about emperic treatment, it's usually ruling out other potential etiologies of pain. We must ensure no one has have an infection, a tumor or other etiologies that are the cause of the pain, and not simply presume that any cyclic progressive pelvic pain is endometriosis – however most of the time it will be due to endometriosis.
Usually with a good history, physical exam, and sometimes with addition of a transvaginal ultrasound, you can rule out other etiologies of pain, and have a very good idea that this pain is related to endometriosis. Based on clinical presentation, and without needing surgery, we can make a clinical diagnosis of endometriosis.
Clinical diagnosis allows patients to have this disease recognized earlier. It allows them to get into treatment sooner and reverses this trend that we've seen of delayed recognition. This delay is especially difficult in younger women in formative years in their life, when they're in school, when they're in an early stage of their career. If they're held back because of this debilitating pain, these are critical times and opportunities they really can't completely make up.
It's very important that we recognize endometriosis early. If we require a laparoscopy to make the diagnosis, the threshold becomes very high and we don't make the diagnosis. We miss a lot of women with endometriosis and don't treat them early.
There was time when our medical options were limited, and we wanted to be sure of our diagnosis. But these days, I think we can make a clinical diagnosis knowing that we have several treatment options that are relatively easy and safe for patients. Our first line therapy-- the first thing I use when I make the clinical diagnosis of endometriosis-- the first emperic treatment I would use is an oral contraceptive.
I prefer giving the oral contraceptive in a continuous fashion, rather than in a cyclic fashion. If someone has dysmenorrhea, why have menses at all? Retrograde menstruation is the etiology of most endometriosis. If we can eliminate menstruation, potentially it may be reducing endometriosis in the long run.
A lot of women with endometriosis will not respond to progestins—a phenomenon called progestin resistance—therefore, not everyone who has endometriosis will respond to an oral contraceptive. Probably about a third of patients either will not initially respond or will develop a resistance to a progestin and fail to respond in the long-term. Still others have side effects due to progestin therapy-- breast tenderness, mood changes, or a feeling of bloating are very common progestin related side effects.
We now have agents like oral GnRH antagonists that we can use as a second line treatment for those that either don't respond to progestins or those who have side effects from a progestin, including a progestin based oral contraceptive. Additionally, in those with severe pain you may want to use something a little more aggressive.
GnRH antagonists are easy to use oral medications, with an immediate onset of action and are easily reversed. We have come a long way from when we had to use an injectable GnRH agonist as the second line therapy. We have much simpler, easy, second line medications that we can turn to that makes empiric treatment a lot easier.
In the past, when we made a surgical diagnosis it was often because we were afraid of committing them to a long course of Depo GnRH agonist treatment; we didn't use a lot of add back therapy and they had tremendous side effects and the risk of bone loss. Patients and their physicians were reluctant to use GnRH agonists.
Things have gotten a lot easier with oral contraceptives, that can be followed by GnRH antagonists, which are easy to use, simple medications that are very patient-friendly. I think we can make that clinical diagnosis. We can move to an empiric treatment, either first or second line with an oral contraceptive or a GnRH antagonist and easily treat these women without significant side effects. It is important that we advocate for women with cyclic pain, and recognize it more readily, clinically diagnosed it, and begin that empiric treatment. That paradigm really has a huge impact on women's lives.
What recent advancements have been made in diagnosing and treating endometriosis?
Dr. Taylor: I think one of the biggest things that I see improving is recognition. Hopefully, we're narrowing that long delay by closing that time gap from initial symptoms to recognition. As we see public awareness grow, patients are recognizing and looking for answers, and thinking to themselves that they may have endometriosis.
Years ago, people were embarrassed to talk about menstruation, painful menstruation, pain with intercourse, pain with bowel movements. Thankfully, we're a more open society now and we can talk about these things. Women are starting to realize that they may have a problem where it was just dismissed before or perhaps, they were embarrassed to talk about it. I think we have seen a huge advancement. Physicians, as well, are recognizing endometriosis even more than before.
I think we're also much more accepting of this clinical diagnosis paradigm and empiric treatment. A lot of that, as we just said, comes from having better, easier to use drugs available that are much more patient-friendly. The GnRH antagonist elagolix is currently available for treatment of endometriosis in the United States. There are two more GnRH antagonists in the pipeline-- relugolix, which we expect to be approved shortly, and linzagolix which is undergoing phase three clinical trials now. Hopefully, we will have several of these second line drugs, drugs which we can even use first line for severe endometriosis. Their availability is another huge advance.
I also think it is essential, that we don't put someone through surgery to recognize endometriosis. We must be better at taking a good history, doing an exam, and ultrasound when needed. You don't need a surgery to diagnose endometriosis.
However, we do still sometimes need surgery to treat endometriosis. Often, endometriosis will cause adhesions or scarring. These long-term sequelae of endometriosis can still require surgery. The medications we have available today are very good at stopping active disease. But the damage done from long-term endometriosis if we don’t treat may still require surgery. I'm hoping that the earlier we start treating people, the less damage will be done, and the less therapeutic surgeries needed. I think these changes are coming and are all very promising.
It would also be great if we had a non-invasive definitive diagnostic test. There are several of those under development, but nothing available yet. I suspect that we'll see those become available very shortly.
The other thing that we still need in the field is a treatment we can use for those women trying to get pregnant. We use in vitro fertilization, which works very well in the endometriosis population. But a medical therapy that can suppress endometriosis and allow people to try to conceive without needing IVF is something I hope for in the future. A specific endometriosis therapy that is not hormonal, that targets the specific pathophysiology of endometriosis, is something that I'd like to see developed and many of us are currently working on.
I think there is a lot coming, but we've already moved the needle a long way. The GnRH antagonists have given us much more confidence in moving forward with clinical diagnosis and empiric treatment of this disease. It's a huge boon for women's health, allowing early recognition and preventing long-term complications of endometriosis.
Dr. Taylor: Endometriosis is a very common disease. Unfortunately, it's still widely under-recognized. It's estimated that perhaps up to 10% of reproductive age women have endometriosis, yet many are never diagnosed or diagnosed late. The average time that it takes for someone to be diagnosed is about 10 years; that is from the time they have classic symptoms of endometriosis until the time they get a definitive diagnosis and treatment.
I think it's very important that we recognize the clinical features of endometriosis. It's absolutely crucial if we want to shorten the time tom diagnosis. Often patients see multiple physicians before they get an accurate diagnosis. They're often dismissed by their early caregivers who are not very familiar with the disease.
For me, the most important feature is the pelvic pain. To identify endometriosis, I look specifically at the cyclic nature of the pelvic pain, and the progressive nature of the pelvic pain. Endometriosis is by far the most common reason that women have pelvic pain and initially it tends to be cyclic. It often starts as dysmenorrhea (painful periods), however it can progress to the point where pain occurs at times outside of menses. In fact, it can progress to the point where it's painful all the time. However, it almost always starts as dysmennorhea, and progresses.
Pelvic pain that someone had from their first menses on, i.e., from menarche, is less likely to be endometriosis than the pain that progresses and becomes worse or spreads to other times of the menstrual cycle. Endometriosis is a progressive disease, and that's one of the key distinctions in making me think somebody has endometriosis.
Most women with cyclic pelvic pain that gets worse over time, cyclic progressive pelvic pain, will have endometriosis. Those are the key features I look for.
It is also very important to recognize that endometriosis can have effects outside of the reproductive tract, can cause systemic inflammation, and impact other organ systems. Bowel and bladder dysfunction are very common. If that is cyclic and coincides with the pelvic pain, it’s very likely to be secondary to endometriosis. It's important not to get distracted or mislead into making other diagnoses.
What are some of the common symptoms and how does that impact your diagnosis evaluation?
Dr. Taylor: The most common symptom we see is that cyclic pelvic pain I just discussed. Pain, often starting as dysmenorrhea, can go on to include pain outside of the time of menses and become more than just dysmenorrhea- pain in other areas. The other common symptom is infertility. Many women with endometriosis do not have severe pain or may not have pain at all, but first present when they have trouble conceiving.
Endometriosis may be the cause of infertility. Sometimes we recognize that it's endometriosis when we do a physical exam or an ultrasound and find an endometrioma. Cyclic pelvic pain is the classic symptom we look for, and infertility is another key symptom that we shouldn't forget.
Can you talk a little bit about empiric treatment, primarily what that means and how prevalent it is in your current practice?
Dr. Taylor: I think one of the problems we have today with the treatment of endometriosis is that it doesn't get recognized and doesn't get treated right away. When we talk about emperic treatment, it's usually ruling out other potential etiologies of pain. We must ensure no one has have an infection, a tumor or other etiologies that are the cause of the pain, and not simply presume that any cyclic progressive pelvic pain is endometriosis – however most of the time it will be due to endometriosis.
Usually with a good history, physical exam, and sometimes with addition of a transvaginal ultrasound, you can rule out other etiologies of pain, and have a very good idea that this pain is related to endometriosis. Based on clinical presentation, and without needing surgery, we can make a clinical diagnosis of endometriosis.
Clinical diagnosis allows patients to have this disease recognized earlier. It allows them to get into treatment sooner and reverses this trend that we've seen of delayed recognition. This delay is especially difficult in younger women in formative years in their life, when they're in school, when they're in an early stage of their career. If they're held back because of this debilitating pain, these are critical times and opportunities they really can't completely make up.
It's very important that we recognize endometriosis early. If we require a laparoscopy to make the diagnosis, the threshold becomes very high and we don't make the diagnosis. We miss a lot of women with endometriosis and don't treat them early.
There was time when our medical options were limited, and we wanted to be sure of our diagnosis. But these days, I think we can make a clinical diagnosis knowing that we have several treatment options that are relatively easy and safe for patients. Our first line therapy-- the first thing I use when I make the clinical diagnosis of endometriosis-- the first emperic treatment I would use is an oral contraceptive.
I prefer giving the oral contraceptive in a continuous fashion, rather than in a cyclic fashion. If someone has dysmenorrhea, why have menses at all? Retrograde menstruation is the etiology of most endometriosis. If we can eliminate menstruation, potentially it may be reducing endometriosis in the long run.
A lot of women with endometriosis will not respond to progestins—a phenomenon called progestin resistance—therefore, not everyone who has endometriosis will respond to an oral contraceptive. Probably about a third of patients either will not initially respond or will develop a resistance to a progestin and fail to respond in the long-term. Still others have side effects due to progestin therapy-- breast tenderness, mood changes, or a feeling of bloating are very common progestin related side effects.
We now have agents like oral GnRH antagonists that we can use as a second line treatment for those that either don't respond to progestins or those who have side effects from a progestin, including a progestin based oral contraceptive. Additionally, in those with severe pain you may want to use something a little more aggressive.
GnRH antagonists are easy to use oral medications, with an immediate onset of action and are easily reversed. We have come a long way from when we had to use an injectable GnRH agonist as the second line therapy. We have much simpler, easy, second line medications that we can turn to that makes empiric treatment a lot easier.
In the past, when we made a surgical diagnosis it was often because we were afraid of committing them to a long course of Depo GnRH agonist treatment; we didn't use a lot of add back therapy and they had tremendous side effects and the risk of bone loss. Patients and their physicians were reluctant to use GnRH agonists.
Things have gotten a lot easier with oral contraceptives, that can be followed by GnRH antagonists, which are easy to use, simple medications that are very patient-friendly. I think we can make that clinical diagnosis. We can move to an empiric treatment, either first or second line with an oral contraceptive or a GnRH antagonist and easily treat these women without significant side effects. It is important that we advocate for women with cyclic pain, and recognize it more readily, clinically diagnosed it, and begin that empiric treatment. That paradigm really has a huge impact on women's lives.
What recent advancements have been made in diagnosing and treating endometriosis?
Dr. Taylor: I think one of the biggest things that I see improving is recognition. Hopefully, we're narrowing that long delay by closing that time gap from initial symptoms to recognition. As we see public awareness grow, patients are recognizing and looking for answers, and thinking to themselves that they may have endometriosis.
Years ago, people were embarrassed to talk about menstruation, painful menstruation, pain with intercourse, pain with bowel movements. Thankfully, we're a more open society now and we can talk about these things. Women are starting to realize that they may have a problem where it was just dismissed before or perhaps, they were embarrassed to talk about it. I think we have seen a huge advancement. Physicians, as well, are recognizing endometriosis even more than before.
I think we're also much more accepting of this clinical diagnosis paradigm and empiric treatment. A lot of that, as we just said, comes from having better, easier to use drugs available that are much more patient-friendly. The GnRH antagonist elagolix is currently available for treatment of endometriosis in the United States. There are two more GnRH antagonists in the pipeline-- relugolix, which we expect to be approved shortly, and linzagolix which is undergoing phase three clinical trials now. Hopefully, we will have several of these second line drugs, drugs which we can even use first line for severe endometriosis. Their availability is another huge advance.
I also think it is essential, that we don't put someone through surgery to recognize endometriosis. We must be better at taking a good history, doing an exam, and ultrasound when needed. You don't need a surgery to diagnose endometriosis.
However, we do still sometimes need surgery to treat endometriosis. Often, endometriosis will cause adhesions or scarring. These long-term sequelae of endometriosis can still require surgery. The medications we have available today are very good at stopping active disease. But the damage done from long-term endometriosis if we don’t treat may still require surgery. I'm hoping that the earlier we start treating people, the less damage will be done, and the less therapeutic surgeries needed. I think these changes are coming and are all very promising.
It would also be great if we had a non-invasive definitive diagnostic test. There are several of those under development, but nothing available yet. I suspect that we'll see those become available very shortly.
The other thing that we still need in the field is a treatment we can use for those women trying to get pregnant. We use in vitro fertilization, which works very well in the endometriosis population. But a medical therapy that can suppress endometriosis and allow people to try to conceive without needing IVF is something I hope for in the future. A specific endometriosis therapy that is not hormonal, that targets the specific pathophysiology of endometriosis, is something that I'd like to see developed and many of us are currently working on.
I think there is a lot coming, but we've already moved the needle a long way. The GnRH antagonists have given us much more confidence in moving forward with clinical diagnosis and empiric treatment of this disease. It's a huge boon for women's health, allowing early recognition and preventing long-term complications of endometriosis.
Dr. Taylor: Endometriosis is a very common disease. Unfortunately, it's still widely under-recognized. It's estimated that perhaps up to 10% of reproductive age women have endometriosis, yet many are never diagnosed or diagnosed late. The average time that it takes for someone to be diagnosed is about 10 years; that is from the time they have classic symptoms of endometriosis until the time they get a definitive diagnosis and treatment.
I think it's very important that we recognize the clinical features of endometriosis. It's absolutely crucial if we want to shorten the time tom diagnosis. Often patients see multiple physicians before they get an accurate diagnosis. They're often dismissed by their early caregivers who are not very familiar with the disease.
For me, the most important feature is the pelvic pain. To identify endometriosis, I look specifically at the cyclic nature of the pelvic pain, and the progressive nature of the pelvic pain. Endometriosis is by far the most common reason that women have pelvic pain and initially it tends to be cyclic. It often starts as dysmenorrhea (painful periods), however it can progress to the point where pain occurs at times outside of menses. In fact, it can progress to the point where it's painful all the time. However, it almost always starts as dysmennorhea, and progresses.
Pelvic pain that someone had from their first menses on, i.e., from menarche, is less likely to be endometriosis than the pain that progresses and becomes worse or spreads to other times of the menstrual cycle. Endometriosis is a progressive disease, and that's one of the key distinctions in making me think somebody has endometriosis.
Most women with cyclic pelvic pain that gets worse over time, cyclic progressive pelvic pain, will have endometriosis. Those are the key features I look for.
It is also very important to recognize that endometriosis can have effects outside of the reproductive tract, can cause systemic inflammation, and impact other organ systems. Bowel and bladder dysfunction are very common. If that is cyclic and coincides with the pelvic pain, it’s very likely to be secondary to endometriosis. It's important not to get distracted or mislead into making other diagnoses.
What are some of the common symptoms and how does that impact your diagnosis evaluation?
Dr. Taylor: The most common symptom we see is that cyclic pelvic pain I just discussed. Pain, often starting as dysmenorrhea, can go on to include pain outside of the time of menses and become more than just dysmenorrhea- pain in other areas. The other common symptom is infertility. Many women with endometriosis do not have severe pain or may not have pain at all, but first present when they have trouble conceiving.
Endometriosis may be the cause of infertility. Sometimes we recognize that it's endometriosis when we do a physical exam or an ultrasound and find an endometrioma. Cyclic pelvic pain is the classic symptom we look for, and infertility is another key symptom that we shouldn't forget.
Can you talk a little bit about empiric treatment, primarily what that means and how prevalent it is in your current practice?
Dr. Taylor: I think one of the problems we have today with the treatment of endometriosis is that it doesn't get recognized and doesn't get treated right away. When we talk about emperic treatment, it's usually ruling out other potential etiologies of pain. We must ensure no one has have an infection, a tumor or other etiologies that are the cause of the pain, and not simply presume that any cyclic progressive pelvic pain is endometriosis – however most of the time it will be due to endometriosis.
Usually with a good history, physical exam, and sometimes with addition of a transvaginal ultrasound, you can rule out other etiologies of pain, and have a very good idea that this pain is related to endometriosis. Based on clinical presentation, and without needing surgery, we can make a clinical diagnosis of endometriosis.
Clinical diagnosis allows patients to have this disease recognized earlier. It allows them to get into treatment sooner and reverses this trend that we've seen of delayed recognition. This delay is especially difficult in younger women in formative years in their life, when they're in school, when they're in an early stage of their career. If they're held back because of this debilitating pain, these are critical times and opportunities they really can't completely make up.
It's very important that we recognize endometriosis early. If we require a laparoscopy to make the diagnosis, the threshold becomes very high and we don't make the diagnosis. We miss a lot of women with endometriosis and don't treat them early.
There was time when our medical options were limited, and we wanted to be sure of our diagnosis. But these days, I think we can make a clinical diagnosis knowing that we have several treatment options that are relatively easy and safe for patients. Our first line therapy-- the first thing I use when I make the clinical diagnosis of endometriosis-- the first emperic treatment I would use is an oral contraceptive.
I prefer giving the oral contraceptive in a continuous fashion, rather than in a cyclic fashion. If someone has dysmenorrhea, why have menses at all? Retrograde menstruation is the etiology of most endometriosis. If we can eliminate menstruation, potentially it may be reducing endometriosis in the long run.
A lot of women with endometriosis will not respond to progestins—a phenomenon called progestin resistance—therefore, not everyone who has endometriosis will respond to an oral contraceptive. Probably about a third of patients either will not initially respond or will develop a resistance to a progestin and fail to respond in the long-term. Still others have side effects due to progestin therapy-- breast tenderness, mood changes, or a feeling of bloating are very common progestin related side effects.
We now have agents like oral GnRH antagonists that we can use as a second line treatment for those that either don't respond to progestins or those who have side effects from a progestin, including a progestin based oral contraceptive. Additionally, in those with severe pain you may want to use something a little more aggressive.
GnRH antagonists are easy to use oral medications, with an immediate onset of action and are easily reversed. We have come a long way from when we had to use an injectable GnRH agonist as the second line therapy. We have much simpler, easy, second line medications that we can turn to that makes empiric treatment a lot easier.
In the past, when we made a surgical diagnosis it was often because we were afraid of committing them to a long course of Depo GnRH agonist treatment; we didn't use a lot of add back therapy and they had tremendous side effects and the risk of bone loss. Patients and their physicians were reluctant to use GnRH agonists.
Things have gotten a lot easier with oral contraceptives, that can be followed by GnRH antagonists, which are easy to use, simple medications that are very patient-friendly. I think we can make that clinical diagnosis. We can move to an empiric treatment, either first or second line with an oral contraceptive or a GnRH antagonist and easily treat these women without significant side effects. It is important that we advocate for women with cyclic pain, and recognize it more readily, clinically diagnosed it, and begin that empiric treatment. That paradigm really has a huge impact on women's lives.
What recent advancements have been made in diagnosing and treating endometriosis?
Dr. Taylor: I think one of the biggest things that I see improving is recognition. Hopefully, we're narrowing that long delay by closing that time gap from initial symptoms to recognition. As we see public awareness grow, patients are recognizing and looking for answers, and thinking to themselves that they may have endometriosis.
Years ago, people were embarrassed to talk about menstruation, painful menstruation, pain with intercourse, pain with bowel movements. Thankfully, we're a more open society now and we can talk about these things. Women are starting to realize that they may have a problem where it was just dismissed before or perhaps, they were embarrassed to talk about it. I think we have seen a huge advancement. Physicians, as well, are recognizing endometriosis even more than before.
I think we're also much more accepting of this clinical diagnosis paradigm and empiric treatment. A lot of that, as we just said, comes from having better, easier to use drugs available that are much more patient-friendly. The GnRH antagonist elagolix is currently available for treatment of endometriosis in the United States. There are two more GnRH antagonists in the pipeline-- relugolix, which we expect to be approved shortly, and linzagolix which is undergoing phase three clinical trials now. Hopefully, we will have several of these second line drugs, drugs which we can even use first line for severe endometriosis. Their availability is another huge advance.
I also think it is essential, that we don't put someone through surgery to recognize endometriosis. We must be better at taking a good history, doing an exam, and ultrasound when needed. You don't need a surgery to diagnose endometriosis.
However, we do still sometimes need surgery to treat endometriosis. Often, endometriosis will cause adhesions or scarring. These long-term sequelae of endometriosis can still require surgery. The medications we have available today are very good at stopping active disease. But the damage done from long-term endometriosis if we don’t treat may still require surgery. I'm hoping that the earlier we start treating people, the less damage will be done, and the less therapeutic surgeries needed. I think these changes are coming and are all very promising.
It would also be great if we had a non-invasive definitive diagnostic test. There are several of those under development, but nothing available yet. I suspect that we'll see those become available very shortly.
The other thing that we still need in the field is a treatment we can use for those women trying to get pregnant. We use in vitro fertilization, which works very well in the endometriosis population. But a medical therapy that can suppress endometriosis and allow people to try to conceive without needing IVF is something I hope for in the future. A specific endometriosis therapy that is not hormonal, that targets the specific pathophysiology of endometriosis, is something that I'd like to see developed and many of us are currently working on.
I think there is a lot coming, but we've already moved the needle a long way. The GnRH antagonists have given us much more confidence in moving forward with clinical diagnosis and empiric treatment of this disease. It's a huge boon for women's health, allowing early recognition and preventing long-term complications of endometriosis.
Racial and ethnic disparities persist in pregnant women with gestational diabetes
Between 2014 and 2020, the frequency of adverse pregnancy outcomes in the United States increased among women with gestational diabetes, with persisting differences in adverse outcomes by race and ethnicity, according to a report in JAMA
“[Previous] population-based studies on racial and ethnic disparities in gestational diabetes have focused on differences in the rate of diagnosis, rather than adverse pregnancy outcomes,” lead author Kartik K. Venkatesh, MD, PhD, of Ohio State University, Columbus, and colleagues explained.
The researchers conducted a cross-sectional, descriptive study to evaluate whether the frequency of adverse pregnancy outcomes with gestational diabetes changed over time and whether the risk of these outcomes differed by maternal race and ethnicity.
The data were obtained from the Centers for Disease Control and Prevention’s National Center for Health Statistics Natality Files. Exposures of interest were year of delivery, as well as race and ethnicity.
Results
The study cohort included 1,560,822 pregnant women with gestational diabetes aged 15-44 years. Among the study participants the mean age was 31 years (standard deviation, 5.5 years) and the majority were White (48%), followed by Hispanic/Latina (27%), Asian/Pacific Islander (13%), and Black (12%).
There was a significant increase in the overall frequency of transfusion (8.0%; 95% confidence interval, 3.8%-12.4%), preeclampsia or gestational hypertension (4.2%; 95% CI, 3.3%-5.2%), NICU admission (1.0%; 95% CI, 0.3%-1.7%), and preterm birth at less than 37 weeks (0.9%; 95% CI, 0.3%-1.5%) from 2014 to 2020 for these women and their infants.
In addition, there was a significant decrease in the following outcomes: macrosomia (–4.7%; 95% CI, –5.3% to –4.0%), cesarean delivery (–1.4%; 95% CI, –1.7% to –1.1%), primary cesarean delivery (–1.2%; 95% CI, –1.5% to –0.9%), and large for gestational age (–2.3%; 95% CI, –2.8% to –1.8%), but there was no significant differences in maternal ICU admission and small-for-gestational-age infants.
From 2014 through 2020, differences in adverse outcomes by race and ethnicity persisted; in comparison with Whites, Black participants were at significantly higher risk of all evaluated outcomes, except for macrosomia and large for gestational age.
Hispanic/Latina and Asian/Pacific Islander individuals were also at significantly higher risk of preterm birth, NICU admission, maternal ICU admission, and small for gestational age. Furthermore, American Indian participants were at significantly higher risk of all evaluated outcomes, except for cesarean delivery and small for gestational age.
Results in context
Health policy researcher Felicia Hill-Briggs, PhD, at the Feinstein Institutes for Medical Research in Manhasset, N.Y. commented: “Two alarming trends highlighted by this study: 1) Racial and ethnic inequities in adverse gestational diabetes outcomes; and 2) the rising rates of gestational diabetes overall – both must and can be halted.”
“Optimizing medical management of gestational diabetes, whether through improved access to diabetes care in pregnancy, behavioral interventions, and pharmacotherapy can decrease the risk of adverse pregnancy outcomes,” Dr. Venkatesh commented. “It is possible that the equitable delivery of these interventions to address glycemic control could decrease racial and ethnic disparities in adverse pregnancy outcomes among individuals with gestational diabetes.”
Dr. Venkatesh and his colleagues acknowledged that a key limitation of the study was the use of administrative data; thus, inferences on maternal care improvements could not be determined.
“Further research could focus on greater understanding of racial and ethnic differences in the management of gestational diabetes,” the researchers concluded.
This study was supported by the Care Innovation and Community Improvement Program at Ohio State University. One author reported receiving grants from the National Institutes of Health outside of this study. The other authors reported no relevant disclosures. Dr. Hill-Briggs had no relevant disclosures.
Between 2014 and 2020, the frequency of adverse pregnancy outcomes in the United States increased among women with gestational diabetes, with persisting differences in adverse outcomes by race and ethnicity, according to a report in JAMA
“[Previous] population-based studies on racial and ethnic disparities in gestational diabetes have focused on differences in the rate of diagnosis, rather than adverse pregnancy outcomes,” lead author Kartik K. Venkatesh, MD, PhD, of Ohio State University, Columbus, and colleagues explained.
The researchers conducted a cross-sectional, descriptive study to evaluate whether the frequency of adverse pregnancy outcomes with gestational diabetes changed over time and whether the risk of these outcomes differed by maternal race and ethnicity.
The data were obtained from the Centers for Disease Control and Prevention’s National Center for Health Statistics Natality Files. Exposures of interest were year of delivery, as well as race and ethnicity.
Results
The study cohort included 1,560,822 pregnant women with gestational diabetes aged 15-44 years. Among the study participants the mean age was 31 years (standard deviation, 5.5 years) and the majority were White (48%), followed by Hispanic/Latina (27%), Asian/Pacific Islander (13%), and Black (12%).
There was a significant increase in the overall frequency of transfusion (8.0%; 95% confidence interval, 3.8%-12.4%), preeclampsia or gestational hypertension (4.2%; 95% CI, 3.3%-5.2%), NICU admission (1.0%; 95% CI, 0.3%-1.7%), and preterm birth at less than 37 weeks (0.9%; 95% CI, 0.3%-1.5%) from 2014 to 2020 for these women and their infants.
In addition, there was a significant decrease in the following outcomes: macrosomia (–4.7%; 95% CI, –5.3% to –4.0%), cesarean delivery (–1.4%; 95% CI, –1.7% to –1.1%), primary cesarean delivery (–1.2%; 95% CI, –1.5% to –0.9%), and large for gestational age (–2.3%; 95% CI, –2.8% to –1.8%), but there was no significant differences in maternal ICU admission and small-for-gestational-age infants.
From 2014 through 2020, differences in adverse outcomes by race and ethnicity persisted; in comparison with Whites, Black participants were at significantly higher risk of all evaluated outcomes, except for macrosomia and large for gestational age.
Hispanic/Latina and Asian/Pacific Islander individuals were also at significantly higher risk of preterm birth, NICU admission, maternal ICU admission, and small for gestational age. Furthermore, American Indian participants were at significantly higher risk of all evaluated outcomes, except for cesarean delivery and small for gestational age.
Results in context
Health policy researcher Felicia Hill-Briggs, PhD, at the Feinstein Institutes for Medical Research in Manhasset, N.Y. commented: “Two alarming trends highlighted by this study: 1) Racial and ethnic inequities in adverse gestational diabetes outcomes; and 2) the rising rates of gestational diabetes overall – both must and can be halted.”
“Optimizing medical management of gestational diabetes, whether through improved access to diabetes care in pregnancy, behavioral interventions, and pharmacotherapy can decrease the risk of adverse pregnancy outcomes,” Dr. Venkatesh commented. “It is possible that the equitable delivery of these interventions to address glycemic control could decrease racial and ethnic disparities in adverse pregnancy outcomes among individuals with gestational diabetes.”
Dr. Venkatesh and his colleagues acknowledged that a key limitation of the study was the use of administrative data; thus, inferences on maternal care improvements could not be determined.
“Further research could focus on greater understanding of racial and ethnic differences in the management of gestational diabetes,” the researchers concluded.
This study was supported by the Care Innovation and Community Improvement Program at Ohio State University. One author reported receiving grants from the National Institutes of Health outside of this study. The other authors reported no relevant disclosures. Dr. Hill-Briggs had no relevant disclosures.
Between 2014 and 2020, the frequency of adverse pregnancy outcomes in the United States increased among women with gestational diabetes, with persisting differences in adverse outcomes by race and ethnicity, according to a report in JAMA
“[Previous] population-based studies on racial and ethnic disparities in gestational diabetes have focused on differences in the rate of diagnosis, rather than adverse pregnancy outcomes,” lead author Kartik K. Venkatesh, MD, PhD, of Ohio State University, Columbus, and colleagues explained.
The researchers conducted a cross-sectional, descriptive study to evaluate whether the frequency of adverse pregnancy outcomes with gestational diabetes changed over time and whether the risk of these outcomes differed by maternal race and ethnicity.
The data were obtained from the Centers for Disease Control and Prevention’s National Center for Health Statistics Natality Files. Exposures of interest were year of delivery, as well as race and ethnicity.
Results
The study cohort included 1,560,822 pregnant women with gestational diabetes aged 15-44 years. Among the study participants the mean age was 31 years (standard deviation, 5.5 years) and the majority were White (48%), followed by Hispanic/Latina (27%), Asian/Pacific Islander (13%), and Black (12%).
There was a significant increase in the overall frequency of transfusion (8.0%; 95% confidence interval, 3.8%-12.4%), preeclampsia or gestational hypertension (4.2%; 95% CI, 3.3%-5.2%), NICU admission (1.0%; 95% CI, 0.3%-1.7%), and preterm birth at less than 37 weeks (0.9%; 95% CI, 0.3%-1.5%) from 2014 to 2020 for these women and their infants.
In addition, there was a significant decrease in the following outcomes: macrosomia (–4.7%; 95% CI, –5.3% to –4.0%), cesarean delivery (–1.4%; 95% CI, –1.7% to –1.1%), primary cesarean delivery (–1.2%; 95% CI, –1.5% to –0.9%), and large for gestational age (–2.3%; 95% CI, –2.8% to –1.8%), but there was no significant differences in maternal ICU admission and small-for-gestational-age infants.
From 2014 through 2020, differences in adverse outcomes by race and ethnicity persisted; in comparison with Whites, Black participants were at significantly higher risk of all evaluated outcomes, except for macrosomia and large for gestational age.
Hispanic/Latina and Asian/Pacific Islander individuals were also at significantly higher risk of preterm birth, NICU admission, maternal ICU admission, and small for gestational age. Furthermore, American Indian participants were at significantly higher risk of all evaluated outcomes, except for cesarean delivery and small for gestational age.
Results in context
Health policy researcher Felicia Hill-Briggs, PhD, at the Feinstein Institutes for Medical Research in Manhasset, N.Y. commented: “Two alarming trends highlighted by this study: 1) Racial and ethnic inequities in adverse gestational diabetes outcomes; and 2) the rising rates of gestational diabetes overall – both must and can be halted.”
“Optimizing medical management of gestational diabetes, whether through improved access to diabetes care in pregnancy, behavioral interventions, and pharmacotherapy can decrease the risk of adverse pregnancy outcomes,” Dr. Venkatesh commented. “It is possible that the equitable delivery of these interventions to address glycemic control could decrease racial and ethnic disparities in adverse pregnancy outcomes among individuals with gestational diabetes.”
Dr. Venkatesh and his colleagues acknowledged that a key limitation of the study was the use of administrative data; thus, inferences on maternal care improvements could not be determined.
“Further research could focus on greater understanding of racial and ethnic differences in the management of gestational diabetes,” the researchers concluded.
This study was supported by the Care Innovation and Community Improvement Program at Ohio State University. One author reported receiving grants from the National Institutes of Health outside of this study. The other authors reported no relevant disclosures. Dr. Hill-Briggs had no relevant disclosures.
FROM JAMA
Breakthrough COVID dangerous for vaccinated cancer patients
study published in JAMA Oncology.
, according to aThe risks were highest among patients who had certain cancers and those who had received cancer treatment within the past year.
“These results emphasize the need for patients with cancer to maintain mitigation practice, especially with the emergence of different virus variants and the waning immunity of vaccines,” the study authors wrote.
Researchers at Case Western Reserve University in Cleveland analyzed electronic health record data for more than 636,000 vaccinated patients, including more than 45,000 vaccinated patients with cancer. They looked for the time trends, risks, and outcomes of breakthrough COVID-19 infections for vaccinated cancer patients in the United States between December 2020 and November 2021.
Overall, the cumulative risk of breakthrough infections in vaccinated cancer patients was 13.6%, with the highest risk for pancreatic (24.7%), liver (22.8%), lung (20.4%), and colorectal (17.5%) cancers and the lowest risk for thyroid (10.3%), endometrial (11.9%), and breast (11.9%) cancers, versus 4.9% in vaccinated patients without cancer.
Patients who had medical encounters for their cancer within the past year had a higher risk for a breakthrough infection, particularly those with breast cancer, blood cancers, colorectal cancer, bladder cancer, and pancreatic cancer.
Among patients with cancer, the overall risk for hospitalization after a breakthrough infection was 31.6%, as compared with 3.9% in those without a breakthrough infection. In addition, the risk of death was 6.7% after a breakthrough infection, as compared with 1.3% in those without a breakthrough infection.
Among patients who didn’t have cancer, the overall hospitalization risk was 25.9% in patients with a breakthrough infection, as compared with 3% in those without a breakthrough infection. The overall risk of death was 2.7% after a breakthrough infection, as compared with 0.5% in those without a breakthrough infection.
In addition, breakthrough infections continuously increased for all patients from December 2020 to November 2021, with the numbers consistently higher among patients with cancer.
“This increasing time trend may reflect waning immunity of vaccines, the emergence of different virus variants, and varied measures taken by individuals and communities over time during the pandemic,” the study authors wrote.
Vaccines are likely less protective against coronavirus infection in cancer patients, and in turn, cancer patients may be more susceptible to COVID-19 infections, the researchers wrote. As breakthrough infections continue to increase for everyone, patients with cancer will face increased risks for severe breakthroughs, hospitalization, and death, they concluded.
A version of this article first appeared on WebMD.com.
study published in JAMA Oncology.
, according to aThe risks were highest among patients who had certain cancers and those who had received cancer treatment within the past year.
“These results emphasize the need for patients with cancer to maintain mitigation practice, especially with the emergence of different virus variants and the waning immunity of vaccines,” the study authors wrote.
Researchers at Case Western Reserve University in Cleveland analyzed electronic health record data for more than 636,000 vaccinated patients, including more than 45,000 vaccinated patients with cancer. They looked for the time trends, risks, and outcomes of breakthrough COVID-19 infections for vaccinated cancer patients in the United States between December 2020 and November 2021.
Overall, the cumulative risk of breakthrough infections in vaccinated cancer patients was 13.6%, with the highest risk for pancreatic (24.7%), liver (22.8%), lung (20.4%), and colorectal (17.5%) cancers and the lowest risk for thyroid (10.3%), endometrial (11.9%), and breast (11.9%) cancers, versus 4.9% in vaccinated patients without cancer.
Patients who had medical encounters for their cancer within the past year had a higher risk for a breakthrough infection, particularly those with breast cancer, blood cancers, colorectal cancer, bladder cancer, and pancreatic cancer.
Among patients with cancer, the overall risk for hospitalization after a breakthrough infection was 31.6%, as compared with 3.9% in those without a breakthrough infection. In addition, the risk of death was 6.7% after a breakthrough infection, as compared with 1.3% in those without a breakthrough infection.
Among patients who didn’t have cancer, the overall hospitalization risk was 25.9% in patients with a breakthrough infection, as compared with 3% in those without a breakthrough infection. The overall risk of death was 2.7% after a breakthrough infection, as compared with 0.5% in those without a breakthrough infection.
In addition, breakthrough infections continuously increased for all patients from December 2020 to November 2021, with the numbers consistently higher among patients with cancer.
“This increasing time trend may reflect waning immunity of vaccines, the emergence of different virus variants, and varied measures taken by individuals and communities over time during the pandemic,” the study authors wrote.
Vaccines are likely less protective against coronavirus infection in cancer patients, and in turn, cancer patients may be more susceptible to COVID-19 infections, the researchers wrote. As breakthrough infections continue to increase for everyone, patients with cancer will face increased risks for severe breakthroughs, hospitalization, and death, they concluded.
A version of this article first appeared on WebMD.com.
study published in JAMA Oncology.
, according to aThe risks were highest among patients who had certain cancers and those who had received cancer treatment within the past year.
“These results emphasize the need for patients with cancer to maintain mitigation practice, especially with the emergence of different virus variants and the waning immunity of vaccines,” the study authors wrote.
Researchers at Case Western Reserve University in Cleveland analyzed electronic health record data for more than 636,000 vaccinated patients, including more than 45,000 vaccinated patients with cancer. They looked for the time trends, risks, and outcomes of breakthrough COVID-19 infections for vaccinated cancer patients in the United States between December 2020 and November 2021.
Overall, the cumulative risk of breakthrough infections in vaccinated cancer patients was 13.6%, with the highest risk for pancreatic (24.7%), liver (22.8%), lung (20.4%), and colorectal (17.5%) cancers and the lowest risk for thyroid (10.3%), endometrial (11.9%), and breast (11.9%) cancers, versus 4.9% in vaccinated patients without cancer.
Patients who had medical encounters for their cancer within the past year had a higher risk for a breakthrough infection, particularly those with breast cancer, blood cancers, colorectal cancer, bladder cancer, and pancreatic cancer.
Among patients with cancer, the overall risk for hospitalization after a breakthrough infection was 31.6%, as compared with 3.9% in those without a breakthrough infection. In addition, the risk of death was 6.7% after a breakthrough infection, as compared with 1.3% in those without a breakthrough infection.
Among patients who didn’t have cancer, the overall hospitalization risk was 25.9% in patients with a breakthrough infection, as compared with 3% in those without a breakthrough infection. The overall risk of death was 2.7% after a breakthrough infection, as compared with 0.5% in those without a breakthrough infection.
In addition, breakthrough infections continuously increased for all patients from December 2020 to November 2021, with the numbers consistently higher among patients with cancer.
“This increasing time trend may reflect waning immunity of vaccines, the emergence of different virus variants, and varied measures taken by individuals and communities over time during the pandemic,” the study authors wrote.
Vaccines are likely less protective against coronavirus infection in cancer patients, and in turn, cancer patients may be more susceptible to COVID-19 infections, the researchers wrote. As breakthrough infections continue to increase for everyone, patients with cancer will face increased risks for severe breakthroughs, hospitalization, and death, they concluded.
A version of this article first appeared on WebMD.com.
FROM JAMA ONCOLOGY
Meningococcal vaccine shows moderate protective effect against gonorrhea
A widely approved vaccine for meningitis may provide up to 40% protection against gonorrhea in young adults and adolescents, according to new research. This moderate efficacy paired with a targeted risk-based approach could reduce cases as well as lead to health care savings over 10 years, an additional modeling study showed.
The results – in three linked papers – were published in The Lancet Infectious Diseases.
Gonorrhea, caused by the bacterium Neisseria gonorrhoeae, is the second most commonly reported sexually transmitted infection in the United States, according to the Centers for Disease Control and Prevention. Globally, the World Health Organization estimates that there were 82.4 million new cases in people aged 15-49 in 2020. At the same time, it is becoming more difficult to treat the infection because of the increasing prevalence of drug-resistant strains of N. gonorrhoeae.
“New approaches, such as vaccination, are needed as long-term strategies to prevent gonorrhea and address the emerging threat of antimicrobial resistance,” Winston Abara, MD, PhD, Division of STD Prevention, Centers for Disease Control and Prevention, and colleagues wrote.
While there is currently no vaccine for gonorrhea, observational studies have found an association between a meningococcal serogroup B vaccine and reduced gonorrhea cases. One study in New Zealand found that people vaccinated with the MeNZB vaccine, which was produced to control an outbreak of meningococcal disease in the country, were 31% less likely to contract gonorrhea.
This cross-reactivity comes about because Neisseria meningitidis, the bacterium that can cause meningitis, is closely related to N. gonorrhoeae, Joseph Alex Duncan, MD, PhD, associate professor of medicine, Division of Infectious Diseases, University of North Carolina School of Medicine, Chapel Hill, said in an interview. He was not involved with the research. The thought is that “a large proportion of the proteins that are in the vaccine also recognize proteins from Neisseria gonorrhea, because the bacteria are so similar at the genetic level,” he said.
To see if this association was still found for the four-component serogroup B meningococcal vaccine (MenB-4C), which is now widely available, Dr. Abara and colleagues looked through health records to identify laboratory-confirmed gonorrhea and chlamydia infections in adolescents and young adults in New York City and Philadelphia. All individuals included in the analysis were age 16-23 and all infections occurred between Jan. 1, 2016, and Dec. 31, 2018. These infections were then linked to vaccination records to determine individuals’ MenB-4C vaccination status. Complete vaccination was defined as two MenB-4C doses, delivered 30-180 days apart.
The research team identified over 167,700 infections, including 18,099 gonococcal infections, 124,876 chlamydial infections, and 24,731 coinfections, among 109,737 individuals. A total of 7,692 individuals had received at least one shot of the vaccine, and 3,660 people were fully vaccinated. Full MenB-4C vaccination was estimated to be 40% protective (APR 0.60; P < .0001) against gonorrhea, and partial vaccination was 26% protective (APR 0.74; P = .0012).
“The findings of our study add to the body of evidence that demonstrates that the MenB-4C may offer cross-protection against Neisseria gonorrhoeae, and it supports feasibility of an effective gonococcal vaccine with implications for gonorrhea prevention and control,” Dr. Abara told this news organization.
A second study conducted in South Australia looked at the effectiveness of the MenB-4C vaccine against meningitis and gonorrhea as part of a vaccination program. Using infection data from the Government of South Australia and vaccination records from the Australian Immunization Register, researchers identified individuals born between Feb. 1, 1998, and Feb. 1, 2005, with a documented gonorrhea or chlamydia infection between Feb. 1, 2019, and Jan. 31, 2021. Individuals with chlamydia served as the controls to account for similar sexual behavioral risks.
The analysis included 512 individuals with 575 cases of gonorrhea and 3,140 individuals with 3,847 episodes of chlamydia. In this group, the estimated vaccine effectiveness against gonorrhea was 32.7% (95% confidence interval, 8.3-50.6) in individuals who were fully vaccinated and 32.6% (95% CI, 10.6-49.1) in those who had received at least one dose of the MenB-4C.
While these findings are “confirmatory” because they showed results similar to those in previous observational studies, they are still exciting, Dr. Duncan said. “Up until now, we really haven’t had any real progress in knowing what type of immune responses could actually be protective from the disease,” he said. “These observational studies have really reinvigorated the Neisseria gonorrhea vaccine research community.”
A vaccine with moderate efficacy – like the protection demonstrated in both studies – could lead to a significant reduction in cases, he noted. A 2015 Australian modeling study estimated that a nonwaning vaccine with 20% efficacy could reduce cases by 40% over 20 years. Focusing on vaccinating higher-risk groups could also have an “outsize impact,” said Jeanne Marrazzo, MD, director, Division of Infectious Diseases, UAB Medicine, Birmingham, Alabama, in an interview. In the third study published in The Lancet, researchers estimated the possible reduction of cases and the potential health care cost savings in England in a vaccination effort focusing on men who have sex with men (MSM) at high risk for gonorrhea infection. They predicted that a vaccine with 31% efficacy could prevent 110,200 cases in MSM and save about £8 million ($10.4 million) over 10 years.
Both Dr. Duncan and Dr. Marrazzo agreed that clinical trials are needed to tease out whether the decrease in gonorrhea cases is due to the MenB-4C vaccine or the association is incidental. There are two ongoing clinical trials, one in Australia and one in the United States. Dr. Marrazzo leads the U.S. multicenter study, which also has two locations in Bangkok. The trial will also look at whether vaccination protection varies by the location of gonococcal infection: urethra, rectum, cervix, or pharynx. The two new observational studies did not distinguish the different sites of infection.
Dr. Marrazzo’s trial has enrolled almost 500 individuals so far, with the goal of enrolling over 2,000 participants in total. She hopes to see results by late 2023. “It’s a pretty ambitious effort, but I’m hoping it will give us not only a definitive answer in terms of reduction in infection by anatomic site,” she said, but “also give us a lot of information about how the immune response works to protect you from getting gonorrhea if you do get the vaccine.”
Dr. Duncan has received research grants from the National Institutes of Health. Dr. Marrazzo leads a clinical trial of the MenB-4C vaccine sponsored by the National Institute of Allergy and Infectious Diseases.
A version of this article first appeared on Medscape.com.
A widely approved vaccine for meningitis may provide up to 40% protection against gonorrhea in young adults and adolescents, according to new research. This moderate efficacy paired with a targeted risk-based approach could reduce cases as well as lead to health care savings over 10 years, an additional modeling study showed.
The results – in three linked papers – were published in The Lancet Infectious Diseases.
Gonorrhea, caused by the bacterium Neisseria gonorrhoeae, is the second most commonly reported sexually transmitted infection in the United States, according to the Centers for Disease Control and Prevention. Globally, the World Health Organization estimates that there were 82.4 million new cases in people aged 15-49 in 2020. At the same time, it is becoming more difficult to treat the infection because of the increasing prevalence of drug-resistant strains of N. gonorrhoeae.
“New approaches, such as vaccination, are needed as long-term strategies to prevent gonorrhea and address the emerging threat of antimicrobial resistance,” Winston Abara, MD, PhD, Division of STD Prevention, Centers for Disease Control and Prevention, and colleagues wrote.
While there is currently no vaccine for gonorrhea, observational studies have found an association between a meningococcal serogroup B vaccine and reduced gonorrhea cases. One study in New Zealand found that people vaccinated with the MeNZB vaccine, which was produced to control an outbreak of meningococcal disease in the country, were 31% less likely to contract gonorrhea.
This cross-reactivity comes about because Neisseria meningitidis, the bacterium that can cause meningitis, is closely related to N. gonorrhoeae, Joseph Alex Duncan, MD, PhD, associate professor of medicine, Division of Infectious Diseases, University of North Carolina School of Medicine, Chapel Hill, said in an interview. He was not involved with the research. The thought is that “a large proportion of the proteins that are in the vaccine also recognize proteins from Neisseria gonorrhea, because the bacteria are so similar at the genetic level,” he said.
To see if this association was still found for the four-component serogroup B meningococcal vaccine (MenB-4C), which is now widely available, Dr. Abara and colleagues looked through health records to identify laboratory-confirmed gonorrhea and chlamydia infections in adolescents and young adults in New York City and Philadelphia. All individuals included in the analysis were age 16-23 and all infections occurred between Jan. 1, 2016, and Dec. 31, 2018. These infections were then linked to vaccination records to determine individuals’ MenB-4C vaccination status. Complete vaccination was defined as two MenB-4C doses, delivered 30-180 days apart.
The research team identified over 167,700 infections, including 18,099 gonococcal infections, 124,876 chlamydial infections, and 24,731 coinfections, among 109,737 individuals. A total of 7,692 individuals had received at least one shot of the vaccine, and 3,660 people were fully vaccinated. Full MenB-4C vaccination was estimated to be 40% protective (APR 0.60; P < .0001) against gonorrhea, and partial vaccination was 26% protective (APR 0.74; P = .0012).
“The findings of our study add to the body of evidence that demonstrates that the MenB-4C may offer cross-protection against Neisseria gonorrhoeae, and it supports feasibility of an effective gonococcal vaccine with implications for gonorrhea prevention and control,” Dr. Abara told this news organization.
A second study conducted in South Australia looked at the effectiveness of the MenB-4C vaccine against meningitis and gonorrhea as part of a vaccination program. Using infection data from the Government of South Australia and vaccination records from the Australian Immunization Register, researchers identified individuals born between Feb. 1, 1998, and Feb. 1, 2005, with a documented gonorrhea or chlamydia infection between Feb. 1, 2019, and Jan. 31, 2021. Individuals with chlamydia served as the controls to account for similar sexual behavioral risks.
The analysis included 512 individuals with 575 cases of gonorrhea and 3,140 individuals with 3,847 episodes of chlamydia. In this group, the estimated vaccine effectiveness against gonorrhea was 32.7% (95% confidence interval, 8.3-50.6) in individuals who were fully vaccinated and 32.6% (95% CI, 10.6-49.1) in those who had received at least one dose of the MenB-4C.
While these findings are “confirmatory” because they showed results similar to those in previous observational studies, they are still exciting, Dr. Duncan said. “Up until now, we really haven’t had any real progress in knowing what type of immune responses could actually be protective from the disease,” he said. “These observational studies have really reinvigorated the Neisseria gonorrhea vaccine research community.”
A vaccine with moderate efficacy – like the protection demonstrated in both studies – could lead to a significant reduction in cases, he noted. A 2015 Australian modeling study estimated that a nonwaning vaccine with 20% efficacy could reduce cases by 40% over 20 years. Focusing on vaccinating higher-risk groups could also have an “outsize impact,” said Jeanne Marrazzo, MD, director, Division of Infectious Diseases, UAB Medicine, Birmingham, Alabama, in an interview. In the third study published in The Lancet, researchers estimated the possible reduction of cases and the potential health care cost savings in England in a vaccination effort focusing on men who have sex with men (MSM) at high risk for gonorrhea infection. They predicted that a vaccine with 31% efficacy could prevent 110,200 cases in MSM and save about £8 million ($10.4 million) over 10 years.
Both Dr. Duncan and Dr. Marrazzo agreed that clinical trials are needed to tease out whether the decrease in gonorrhea cases is due to the MenB-4C vaccine or the association is incidental. There are two ongoing clinical trials, one in Australia and one in the United States. Dr. Marrazzo leads the U.S. multicenter study, which also has two locations in Bangkok. The trial will also look at whether vaccination protection varies by the location of gonococcal infection: urethra, rectum, cervix, or pharynx. The two new observational studies did not distinguish the different sites of infection.
Dr. Marrazzo’s trial has enrolled almost 500 individuals so far, with the goal of enrolling over 2,000 participants in total. She hopes to see results by late 2023. “It’s a pretty ambitious effort, but I’m hoping it will give us not only a definitive answer in terms of reduction in infection by anatomic site,” she said, but “also give us a lot of information about how the immune response works to protect you from getting gonorrhea if you do get the vaccine.”
Dr. Duncan has received research grants from the National Institutes of Health. Dr. Marrazzo leads a clinical trial of the MenB-4C vaccine sponsored by the National Institute of Allergy and Infectious Diseases.
A version of this article first appeared on Medscape.com.
A widely approved vaccine for meningitis may provide up to 40% protection against gonorrhea in young adults and adolescents, according to new research. This moderate efficacy paired with a targeted risk-based approach could reduce cases as well as lead to health care savings over 10 years, an additional modeling study showed.
The results – in three linked papers – were published in The Lancet Infectious Diseases.
Gonorrhea, caused by the bacterium Neisseria gonorrhoeae, is the second most commonly reported sexually transmitted infection in the United States, according to the Centers for Disease Control and Prevention. Globally, the World Health Organization estimates that there were 82.4 million new cases in people aged 15-49 in 2020. At the same time, it is becoming more difficult to treat the infection because of the increasing prevalence of drug-resistant strains of N. gonorrhoeae.
“New approaches, such as vaccination, are needed as long-term strategies to prevent gonorrhea and address the emerging threat of antimicrobial resistance,” Winston Abara, MD, PhD, Division of STD Prevention, Centers for Disease Control and Prevention, and colleagues wrote.
While there is currently no vaccine for gonorrhea, observational studies have found an association between a meningococcal serogroup B vaccine and reduced gonorrhea cases. One study in New Zealand found that people vaccinated with the MeNZB vaccine, which was produced to control an outbreak of meningococcal disease in the country, were 31% less likely to contract gonorrhea.
This cross-reactivity comes about because Neisseria meningitidis, the bacterium that can cause meningitis, is closely related to N. gonorrhoeae, Joseph Alex Duncan, MD, PhD, associate professor of medicine, Division of Infectious Diseases, University of North Carolina School of Medicine, Chapel Hill, said in an interview. He was not involved with the research. The thought is that “a large proportion of the proteins that are in the vaccine also recognize proteins from Neisseria gonorrhea, because the bacteria are so similar at the genetic level,” he said.
To see if this association was still found for the four-component serogroup B meningococcal vaccine (MenB-4C), which is now widely available, Dr. Abara and colleagues looked through health records to identify laboratory-confirmed gonorrhea and chlamydia infections in adolescents and young adults in New York City and Philadelphia. All individuals included in the analysis were age 16-23 and all infections occurred between Jan. 1, 2016, and Dec. 31, 2018. These infections were then linked to vaccination records to determine individuals’ MenB-4C vaccination status. Complete vaccination was defined as two MenB-4C doses, delivered 30-180 days apart.
The research team identified over 167,700 infections, including 18,099 gonococcal infections, 124,876 chlamydial infections, and 24,731 coinfections, among 109,737 individuals. A total of 7,692 individuals had received at least one shot of the vaccine, and 3,660 people were fully vaccinated. Full MenB-4C vaccination was estimated to be 40% protective (APR 0.60; P < .0001) against gonorrhea, and partial vaccination was 26% protective (APR 0.74; P = .0012).
“The findings of our study add to the body of evidence that demonstrates that the MenB-4C may offer cross-protection against Neisseria gonorrhoeae, and it supports feasibility of an effective gonococcal vaccine with implications for gonorrhea prevention and control,” Dr. Abara told this news organization.
A second study conducted in South Australia looked at the effectiveness of the MenB-4C vaccine against meningitis and gonorrhea as part of a vaccination program. Using infection data from the Government of South Australia and vaccination records from the Australian Immunization Register, researchers identified individuals born between Feb. 1, 1998, and Feb. 1, 2005, with a documented gonorrhea or chlamydia infection between Feb. 1, 2019, and Jan. 31, 2021. Individuals with chlamydia served as the controls to account for similar sexual behavioral risks.
The analysis included 512 individuals with 575 cases of gonorrhea and 3,140 individuals with 3,847 episodes of chlamydia. In this group, the estimated vaccine effectiveness against gonorrhea was 32.7% (95% confidence interval, 8.3-50.6) in individuals who were fully vaccinated and 32.6% (95% CI, 10.6-49.1) in those who had received at least one dose of the MenB-4C.
While these findings are “confirmatory” because they showed results similar to those in previous observational studies, they are still exciting, Dr. Duncan said. “Up until now, we really haven’t had any real progress in knowing what type of immune responses could actually be protective from the disease,” he said. “These observational studies have really reinvigorated the Neisseria gonorrhea vaccine research community.”
A vaccine with moderate efficacy – like the protection demonstrated in both studies – could lead to a significant reduction in cases, he noted. A 2015 Australian modeling study estimated that a nonwaning vaccine with 20% efficacy could reduce cases by 40% over 20 years. Focusing on vaccinating higher-risk groups could also have an “outsize impact,” said Jeanne Marrazzo, MD, director, Division of Infectious Diseases, UAB Medicine, Birmingham, Alabama, in an interview. In the third study published in The Lancet, researchers estimated the possible reduction of cases and the potential health care cost savings in England in a vaccination effort focusing on men who have sex with men (MSM) at high risk for gonorrhea infection. They predicted that a vaccine with 31% efficacy could prevent 110,200 cases in MSM and save about £8 million ($10.4 million) over 10 years.
Both Dr. Duncan and Dr. Marrazzo agreed that clinical trials are needed to tease out whether the decrease in gonorrhea cases is due to the MenB-4C vaccine or the association is incidental. There are two ongoing clinical trials, one in Australia and one in the United States. Dr. Marrazzo leads the U.S. multicenter study, which also has two locations in Bangkok. The trial will also look at whether vaccination protection varies by the location of gonococcal infection: urethra, rectum, cervix, or pharynx. The two new observational studies did not distinguish the different sites of infection.
Dr. Marrazzo’s trial has enrolled almost 500 individuals so far, with the goal of enrolling over 2,000 participants in total. She hopes to see results by late 2023. “It’s a pretty ambitious effort, but I’m hoping it will give us not only a definitive answer in terms of reduction in infection by anatomic site,” she said, but “also give us a lot of information about how the immune response works to protect you from getting gonorrhea if you do get the vaccine.”
Dr. Duncan has received research grants from the National Institutes of Health. Dr. Marrazzo leads a clinical trial of the MenB-4C vaccine sponsored by the National Institute of Allergy and Infectious Diseases.
A version of this article first appeared on Medscape.com.
FROM THE LANCET INFECTIOUS DISEASES
‘Forever chemicals’ exposures may compound diabetes risk
Women in midlife exposed to combinations of perfluoroalkyl and polyfluoroalkyl substances (PFASs), dubbed “forever and everywhere chemicals”, are at increased risk of developing diabetes, similar to the magnitude of risk associated with overweight and even greater than the risk associated with smoking, new research shows.
“This is the first study to examine the joint effect of PFAS on incident diabetes,” first author Sung Kyun Park, ScD, MPH, told this news organization.
“We showed that multiple PFAS as mixtures have larger effects than individual PFAS,” said Dr. Park, of the department of epidemiology, School of Public Health, University of Michigan, Ann Arbor.
The results suggest that, “given that 1.5 million Americans are newly diagnosed with diabetes each year in the USA, approximately 370,000 new cases of diabetes annually in the U.S. are attributable to PFAS exposure,” Dr. Park and authors note in the study, published in Diabetologia.
However, Kevin McConway, PhD, emeritus professor of applied statistics, The Open University, U.K., told the UK Science Media Centre: “[Some] doubt about cause still remains. Yes, this study does show that PFAS may increase diabetes risk in middle-aged women, but it certainly can’t rule out other explanations for its findings.”
Is there any way to reduce exposure?
PFASs, known to be ubiquitous in the environment and also often dubbed “endocrine-disrupting” chemicals, have structures similar to fatty acids. They have been detected in the blood of most people and linked to health concerns including pre-eclampsia, altered levels of liver enzymes, inflammation, and altered lipid and glucose metabolism.
Sources of PFAS exposure can run the gamut from nonstick cookware, food wrappers, and waterproof fabrics to cosmetics and even drinking water.
The authors note a recent Consumer Reports investigation of 118 food packaging products, for instance, which reported finding PFAS chemicals in the packaging of every fast-food chain and retailer examined, including Burger King, McDonald’s, and even more health-focused chains, such as Trader Joe’s.
While efforts to pressure industry to limit PFAS in products are ongoing, Dr. Park asserted that “PFAS exposure reduction at the individual-level is very limited, so a more important way is to change policies and to limit PFAS in the air, drinking water, and foods, etc.”
“It is impossible to completely avoid exposure to PFAS, but I think it is important to acknowledge such sources and change our mindset,” he said.
In terms of clinical practice, the authors add that “it is also important for clinicians to be aware of PFAS as unrecognized risk factors for diabetes and to be prepared to counsel patients in terms of sources of exposure and potential health effects.”
Prospective findings from the SWAN-MPS study
The findings come from a prospective study of 1,237 women, with a median age of 49.4 years, who were diabetes-free upon entering the Study of Women’s Health Across the Nation – Multi-Pollutant Study (SWAN-MPS) between 1999 and 2000 and followed until 2017.
Blood samples taken throughout the study were analyzed for serum concentrations of seven PFASs.
Over the study period, there were 102 cases of incident diabetes, representing a rate of 6 cases per 1,000 person-years. Type of diabetes was not determined, but given the age of study participants, most were assumed to have type 2 diabetes, Dr. Park and colleagues note.
After adjustment for key confounders including race/ethnicity, smoking status, alcohol consumption, total energy intake, physical activity, menopausal status, and body mass index (BMI), those in the highest tertile of exposure to a combination of all seven of the PFASs were significantly more likely to develop diabetes, compared with those in the lowest tertile for exposure (hazard ratio, 2.62).
This risk was greater than that seen with individual PFASs (HR, 1.36-1.85), suggesting a potential additive or synergistic effect of multiple PFASs on diabetes risk.
The association between the combined exposure to PFASs among the highest versus lowest tertile was similar to the risk of diabetes developing among those with overweight (BMI 25-< 30 kg/m2) versus normal weight (HR, 2.89) and higher than the risk among current versus never smokers (HR, 2.30).
“Our findings suggest that PFAS may be an important risk factor for diabetes that has a substantial public health impact,” the authors say.
“Given the widespread exposure to PFAS in the general population, the expected benefit of reducing exposure to these ubiquitous chemicals might be considerable,” they emphasize.
The authors have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Women in midlife exposed to combinations of perfluoroalkyl and polyfluoroalkyl substances (PFASs), dubbed “forever and everywhere chemicals”, are at increased risk of developing diabetes, similar to the magnitude of risk associated with overweight and even greater than the risk associated with smoking, new research shows.
“This is the first study to examine the joint effect of PFAS on incident diabetes,” first author Sung Kyun Park, ScD, MPH, told this news organization.
“We showed that multiple PFAS as mixtures have larger effects than individual PFAS,” said Dr. Park, of the department of epidemiology, School of Public Health, University of Michigan, Ann Arbor.
The results suggest that, “given that 1.5 million Americans are newly diagnosed with diabetes each year in the USA, approximately 370,000 new cases of diabetes annually in the U.S. are attributable to PFAS exposure,” Dr. Park and authors note in the study, published in Diabetologia.
However, Kevin McConway, PhD, emeritus professor of applied statistics, The Open University, U.K., told the UK Science Media Centre: “[Some] doubt about cause still remains. Yes, this study does show that PFAS may increase diabetes risk in middle-aged women, but it certainly can’t rule out other explanations for its findings.”
Is there any way to reduce exposure?
PFASs, known to be ubiquitous in the environment and also often dubbed “endocrine-disrupting” chemicals, have structures similar to fatty acids. They have been detected in the blood of most people and linked to health concerns including pre-eclampsia, altered levels of liver enzymes, inflammation, and altered lipid and glucose metabolism.
Sources of PFAS exposure can run the gamut from nonstick cookware, food wrappers, and waterproof fabrics to cosmetics and even drinking water.
The authors note a recent Consumer Reports investigation of 118 food packaging products, for instance, which reported finding PFAS chemicals in the packaging of every fast-food chain and retailer examined, including Burger King, McDonald’s, and even more health-focused chains, such as Trader Joe’s.
While efforts to pressure industry to limit PFAS in products are ongoing, Dr. Park asserted that “PFAS exposure reduction at the individual-level is very limited, so a more important way is to change policies and to limit PFAS in the air, drinking water, and foods, etc.”
“It is impossible to completely avoid exposure to PFAS, but I think it is important to acknowledge such sources and change our mindset,” he said.
In terms of clinical practice, the authors add that “it is also important for clinicians to be aware of PFAS as unrecognized risk factors for diabetes and to be prepared to counsel patients in terms of sources of exposure and potential health effects.”
Prospective findings from the SWAN-MPS study
The findings come from a prospective study of 1,237 women, with a median age of 49.4 years, who were diabetes-free upon entering the Study of Women’s Health Across the Nation – Multi-Pollutant Study (SWAN-MPS) between 1999 and 2000 and followed until 2017.
Blood samples taken throughout the study were analyzed for serum concentrations of seven PFASs.
Over the study period, there were 102 cases of incident diabetes, representing a rate of 6 cases per 1,000 person-years. Type of diabetes was not determined, but given the age of study participants, most were assumed to have type 2 diabetes, Dr. Park and colleagues note.
After adjustment for key confounders including race/ethnicity, smoking status, alcohol consumption, total energy intake, physical activity, menopausal status, and body mass index (BMI), those in the highest tertile of exposure to a combination of all seven of the PFASs were significantly more likely to develop diabetes, compared with those in the lowest tertile for exposure (hazard ratio, 2.62).
This risk was greater than that seen with individual PFASs (HR, 1.36-1.85), suggesting a potential additive or synergistic effect of multiple PFASs on diabetes risk.
The association between the combined exposure to PFASs among the highest versus lowest tertile was similar to the risk of diabetes developing among those with overweight (BMI 25-< 30 kg/m2) versus normal weight (HR, 2.89) and higher than the risk among current versus never smokers (HR, 2.30).
“Our findings suggest that PFAS may be an important risk factor for diabetes that has a substantial public health impact,” the authors say.
“Given the widespread exposure to PFAS in the general population, the expected benefit of reducing exposure to these ubiquitous chemicals might be considerable,” they emphasize.
The authors have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Women in midlife exposed to combinations of perfluoroalkyl and polyfluoroalkyl substances (PFASs), dubbed “forever and everywhere chemicals”, are at increased risk of developing diabetes, similar to the magnitude of risk associated with overweight and even greater than the risk associated with smoking, new research shows.
“This is the first study to examine the joint effect of PFAS on incident diabetes,” first author Sung Kyun Park, ScD, MPH, told this news organization.
“We showed that multiple PFAS as mixtures have larger effects than individual PFAS,” said Dr. Park, of the department of epidemiology, School of Public Health, University of Michigan, Ann Arbor.
The results suggest that, “given that 1.5 million Americans are newly diagnosed with diabetes each year in the USA, approximately 370,000 new cases of diabetes annually in the U.S. are attributable to PFAS exposure,” Dr. Park and authors note in the study, published in Diabetologia.
However, Kevin McConway, PhD, emeritus professor of applied statistics, The Open University, U.K., told the UK Science Media Centre: “[Some] doubt about cause still remains. Yes, this study does show that PFAS may increase diabetes risk in middle-aged women, but it certainly can’t rule out other explanations for its findings.”
Is there any way to reduce exposure?
PFASs, known to be ubiquitous in the environment and also often dubbed “endocrine-disrupting” chemicals, have structures similar to fatty acids. They have been detected in the blood of most people and linked to health concerns including pre-eclampsia, altered levels of liver enzymes, inflammation, and altered lipid and glucose metabolism.
Sources of PFAS exposure can run the gamut from nonstick cookware, food wrappers, and waterproof fabrics to cosmetics and even drinking water.
The authors note a recent Consumer Reports investigation of 118 food packaging products, for instance, which reported finding PFAS chemicals in the packaging of every fast-food chain and retailer examined, including Burger King, McDonald’s, and even more health-focused chains, such as Trader Joe’s.
While efforts to pressure industry to limit PFAS in products are ongoing, Dr. Park asserted that “PFAS exposure reduction at the individual-level is very limited, so a more important way is to change policies and to limit PFAS in the air, drinking water, and foods, etc.”
“It is impossible to completely avoid exposure to PFAS, but I think it is important to acknowledge such sources and change our mindset,” he said.
In terms of clinical practice, the authors add that “it is also important for clinicians to be aware of PFAS as unrecognized risk factors for diabetes and to be prepared to counsel patients in terms of sources of exposure and potential health effects.”
Prospective findings from the SWAN-MPS study
The findings come from a prospective study of 1,237 women, with a median age of 49.4 years, who were diabetes-free upon entering the Study of Women’s Health Across the Nation – Multi-Pollutant Study (SWAN-MPS) between 1999 and 2000 and followed until 2017.
Blood samples taken throughout the study were analyzed for serum concentrations of seven PFASs.
Over the study period, there were 102 cases of incident diabetes, representing a rate of 6 cases per 1,000 person-years. Type of diabetes was not determined, but given the age of study participants, most were assumed to have type 2 diabetes, Dr. Park and colleagues note.
After adjustment for key confounders including race/ethnicity, smoking status, alcohol consumption, total energy intake, physical activity, menopausal status, and body mass index (BMI), those in the highest tertile of exposure to a combination of all seven of the PFASs were significantly more likely to develop diabetes, compared with those in the lowest tertile for exposure (hazard ratio, 2.62).
This risk was greater than that seen with individual PFASs (HR, 1.36-1.85), suggesting a potential additive or synergistic effect of multiple PFASs on diabetes risk.
The association between the combined exposure to PFASs among the highest versus lowest tertile was similar to the risk of diabetes developing among those with overweight (BMI 25-< 30 kg/m2) versus normal weight (HR, 2.89) and higher than the risk among current versus never smokers (HR, 2.30).
“Our findings suggest that PFAS may be an important risk factor for diabetes that has a substantial public health impact,” the authors say.
“Given the widespread exposure to PFAS in the general population, the expected benefit of reducing exposure to these ubiquitous chemicals might be considerable,” they emphasize.
The authors have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM DIABETOLOGIA
Sex differences in COPD slow to be recognized, treated
When Sigmund Freud claimed that “anatomy is destiny” he was referring to anatomical sex as a determinant of personality traits. Expert consensus statements have previously offered some recommendations for managing these syndromes, but clinical data are scarce, so the present review “is intended to establish a starting point for future research,”
That notion has been widely discredited, but Freud appears to be inadvertently right in one respect: When it comes to chronic obstructive pulmonary disease (COPD), anatomy really is destiny, and sex may be as well, pulmonary researchers say.
There is a growing body of evidence to indicate that COPD affects men and women differently, and that men and women patients with COPD require different clinical management. Yet women are often underdiagnosed or misdiagnosed, partly because of poorly understood sex differences, but also because of cultural biases.
But plunging any farther into the weeds, it’s important to define terms. Although various investigators have used the terms “sex” and “gender” interchangeably, sex is the preferred term when referring to biological attributes of individual patients, while gender refers to personal identity.
These distinctions are important, contended Amik Sodhi, MBBS, MPH, from the division of allergy, pulmonology, and critical care medicine at the University of Wisconsin–Madison.
“Sex is essentially a biologic construct, so it’s got to do with the sex chromosomes, the genetics of that person, and it refers to the anatomic variations that can change susceptibility to different diseases,” she said in an interview.
An example of sex differences or “sexual dimorphism” can be found in a recent meta-analysis of sex-based genetic associations by Megan Hardin, MD, MPH from Brigham & Women’s Hospital in Boston and colleagues.
They reported that CELSR1, a gene involved in fetal lung development, was expressed more among women than among men and that a single nucleotide polymorphism in the gene was associated with COPD among women smokers, but not among men smokers.
The finding points to a potential risk locus for COPD in women, and could help shed light on sexual dimorphism in COPD, Dr. Hardin and colleagues said.
In contrast to sex, “gender is more of a psychosocial construct which can impact how diseases manifest themselves, how they are potentially managed, and what outcomes might occur for that particular disease,” Dr. Sodhi said.
She and her colleagues recently published a review of sex and gender in common lung disorders and sleep in the journal CHEST, where they wrote that the “influence of sex and gender is portrayed in epidemiological data, disease pathogenesis and pathophysiology, clinical manifestations, response to treatment, access to care, and health outcomes. Hence, sex and gender should be considered in all types of research, clinical practice and educational curricula.”
For example, as previously reported at the 2021 annual meeting of the American Thoracic Society, sex-specific differences in the severity of symptoms and prevalence of comorbidities in patients with COPD may point to different criteria for diagnosing cardiac comorbidities in women and men.
Those conclusions came from a retrospective analysis of data on 795 women and 1,251 men with GOLD (Global Initiative for Chronic Obstructive Lung Disease) class 1-3 disease.
The investigators looked at the patients’ clinical history, comorbidities, lung function, COPD Assessment Test scores, and modified Medical Research Council (mMRC) dyspnea score, and found significant differences between men and women for most functional parameters and comorbidities, and for CAT items of cough, phlegm, and energy.
In logistic regression analysis, predictors for cardiac disease in men were energy, mMRC score, smoking status, body mass index, age, and spirometric lung function, but in women only age was significantly predictive for cardiac disease.
An example of gender effects on COPD differences in men and women is the increase in cigarette advertising aimed at women in the 1960s and the advent of women-targeted brands such as Virginia Slims, which in turn lead to increased smoking rates among women. In addition, in the developing world, where the sex/gender gap in COPD is narrowing, women tend to have greater exposure to wood smoke and cooking fuels in unventilated or poorly ventilated spaces, compared with men.
Increasing incidence among women
According to the Centers for Disease Control and Prevention, chronic lower respiratory diseases, primarily COPD, were the fourth-leading cause of death in women in the United States in 2018, following only heart disease, cancer, and accidents/injuries.
And as a CDC analysis of data from the 2013 Behavioral Risk Factor Surveillance System showed, women were more likely to report being told by a physician that they had COPD than did men (6.6%, compared with 5.4%).
Dr. Sodhi and colleagues noted that, at all time points examined from 2005 to 2014, women had a higher proportion than men of COPD hospitalizations and in-hospital deaths. They also noted that female sex is associated with a threefold risk for severe early-onset COPD, and that women with COPD have lower diffusion capacity of lungs for carbon monoxide, despite having higher predicted forced expiratory volume in 1 second, compared with men.
“Historically, COPD wasn’t a disease that was so prevalent in women. It’s been in the past 20 years that the trends have changed,” said Patricia Silveyra, MSc, PhD, ATSF, associate professor of environmental and occupational health at Indiana University, Bloomington.
The increasing prevalence of COPD among women cannot be explained by smoking alone, she said in an interview.
“It used to be thought that it was because more women smoked, but actually a lot of women who don’t smoke can develop COPD, so it appears to be probably something environmental, but because it used to be a disease of older men, in the clinic there was also a bias to diagnose men with COPD, and women with asthma, so a lot of women went underdiagnosed,” Dr. Silveyra said.
In their review, Dr. Sodhi and colleagues noted that women with COPD “may be underdiagnosed as a result of having different symptoms from those classically recognized. Reasons for underdiagnosis or a delay in diagnosis may also be due to lack of a formal evaluation with spirometry, women seeking care later in the course of disease, physician bias, or associated fatigue or depression misdirecting diagnostic strategies. Underdiagnosis may be associated with psychological distress and worse health-related quality of life.”
Although the evidence is mixed, women tend to present more frequently with the chronic bronchitis phenotype of COPD, compared with the emphysema phenotype, and women tend to have greater degrees of pulmonary function impairment when exposed to tobacco smoke, even after controlling for differences in height and weight.
“For the same amount of exposure to tobacco smoke, females are likely to develop more severe airflow limitation at an earlier age than males, and have more exacerbation,” Dr. Sodhi and colleagues wrote.
Both Dr. Silveyra and Dr. Sodhi said that reason why men and women differ in their physiological reactions to smoke are still unknown.
Sex differences in drug responses
There is only limited evidence to indicate that women and men respond differently to various therapeutic agents, but what is clear is that more research into this area is needed, Dr. Sodhi and Dr. Silveyra said.
For example, among the few studies that have documented sex differences, one showed no sex differences in the efficacy of salmeterol/fluticasone combination therapy for reducing exacerbations or improving quality of life, whereas another showed that women were more likely than men to experience COPD symptoms or exacerbations after stopping inhaled corticosteroids, Dr. Sodhi and colleagues noted.
Both Dr. Sodhi and Dr. Silveyra emphasized the need for clinical trials that study the effects of sex on treatment outcomes in COPD, which could lead to better, more personalized therapeutic regimens that take sex and gender into account.
Dr. Sodhi and colleagues offered the following advice to clinicians: “Interaction with female patients should take into account that their symptoms may not conform to traditionally accepted presentations. Challenges exist for female patients at all levels of health care interaction and as clinicians we need to acknowledge the bias and willfully work toward recognition and elimination of unconscious and conscious bias. Empowering our patients to have frank discussions with their health care team when they perceive bias is another step to help promote equity.”
The review by Dr. Sodhi and colleagues was supported by grants from the National Institutes of Health. Dr. Sodhi and Dr. Silveyra reported having no conflicts of interest to disclose.
When Sigmund Freud claimed that “anatomy is destiny” he was referring to anatomical sex as a determinant of personality traits. Expert consensus statements have previously offered some recommendations for managing these syndromes, but clinical data are scarce, so the present review “is intended to establish a starting point for future research,”
That notion has been widely discredited, but Freud appears to be inadvertently right in one respect: When it comes to chronic obstructive pulmonary disease (COPD), anatomy really is destiny, and sex may be as well, pulmonary researchers say.
There is a growing body of evidence to indicate that COPD affects men and women differently, and that men and women patients with COPD require different clinical management. Yet women are often underdiagnosed or misdiagnosed, partly because of poorly understood sex differences, but also because of cultural biases.
But plunging any farther into the weeds, it’s important to define terms. Although various investigators have used the terms “sex” and “gender” interchangeably, sex is the preferred term when referring to biological attributes of individual patients, while gender refers to personal identity.
These distinctions are important, contended Amik Sodhi, MBBS, MPH, from the division of allergy, pulmonology, and critical care medicine at the University of Wisconsin–Madison.
“Sex is essentially a biologic construct, so it’s got to do with the sex chromosomes, the genetics of that person, and it refers to the anatomic variations that can change susceptibility to different diseases,” she said in an interview.
An example of sex differences or “sexual dimorphism” can be found in a recent meta-analysis of sex-based genetic associations by Megan Hardin, MD, MPH from Brigham & Women’s Hospital in Boston and colleagues.
They reported that CELSR1, a gene involved in fetal lung development, was expressed more among women than among men and that a single nucleotide polymorphism in the gene was associated with COPD among women smokers, but not among men smokers.
The finding points to a potential risk locus for COPD in women, and could help shed light on sexual dimorphism in COPD, Dr. Hardin and colleagues said.
In contrast to sex, “gender is more of a psychosocial construct which can impact how diseases manifest themselves, how they are potentially managed, and what outcomes might occur for that particular disease,” Dr. Sodhi said.
She and her colleagues recently published a review of sex and gender in common lung disorders and sleep in the journal CHEST, where they wrote that the “influence of sex and gender is portrayed in epidemiological data, disease pathogenesis and pathophysiology, clinical manifestations, response to treatment, access to care, and health outcomes. Hence, sex and gender should be considered in all types of research, clinical practice and educational curricula.”
For example, as previously reported at the 2021 annual meeting of the American Thoracic Society, sex-specific differences in the severity of symptoms and prevalence of comorbidities in patients with COPD may point to different criteria for diagnosing cardiac comorbidities in women and men.
Those conclusions came from a retrospective analysis of data on 795 women and 1,251 men with GOLD (Global Initiative for Chronic Obstructive Lung Disease) class 1-3 disease.
The investigators looked at the patients’ clinical history, comorbidities, lung function, COPD Assessment Test scores, and modified Medical Research Council (mMRC) dyspnea score, and found significant differences between men and women for most functional parameters and comorbidities, and for CAT items of cough, phlegm, and energy.
In logistic regression analysis, predictors for cardiac disease in men were energy, mMRC score, smoking status, body mass index, age, and spirometric lung function, but in women only age was significantly predictive for cardiac disease.
An example of gender effects on COPD differences in men and women is the increase in cigarette advertising aimed at women in the 1960s and the advent of women-targeted brands such as Virginia Slims, which in turn lead to increased smoking rates among women. In addition, in the developing world, where the sex/gender gap in COPD is narrowing, women tend to have greater exposure to wood smoke and cooking fuels in unventilated or poorly ventilated spaces, compared with men.
Increasing incidence among women
According to the Centers for Disease Control and Prevention, chronic lower respiratory diseases, primarily COPD, were the fourth-leading cause of death in women in the United States in 2018, following only heart disease, cancer, and accidents/injuries.
And as a CDC analysis of data from the 2013 Behavioral Risk Factor Surveillance System showed, women were more likely to report being told by a physician that they had COPD than did men (6.6%, compared with 5.4%).
Dr. Sodhi and colleagues noted that, at all time points examined from 2005 to 2014, women had a higher proportion than men of COPD hospitalizations and in-hospital deaths. They also noted that female sex is associated with a threefold risk for severe early-onset COPD, and that women with COPD have lower diffusion capacity of lungs for carbon monoxide, despite having higher predicted forced expiratory volume in 1 second, compared with men.
“Historically, COPD wasn’t a disease that was so prevalent in women. It’s been in the past 20 years that the trends have changed,” said Patricia Silveyra, MSc, PhD, ATSF, associate professor of environmental and occupational health at Indiana University, Bloomington.
The increasing prevalence of COPD among women cannot be explained by smoking alone, she said in an interview.
“It used to be thought that it was because more women smoked, but actually a lot of women who don’t smoke can develop COPD, so it appears to be probably something environmental, but because it used to be a disease of older men, in the clinic there was also a bias to diagnose men with COPD, and women with asthma, so a lot of women went underdiagnosed,” Dr. Silveyra said.
In their review, Dr. Sodhi and colleagues noted that women with COPD “may be underdiagnosed as a result of having different symptoms from those classically recognized. Reasons for underdiagnosis or a delay in diagnosis may also be due to lack of a formal evaluation with spirometry, women seeking care later in the course of disease, physician bias, or associated fatigue or depression misdirecting diagnostic strategies. Underdiagnosis may be associated with psychological distress and worse health-related quality of life.”
Although the evidence is mixed, women tend to present more frequently with the chronic bronchitis phenotype of COPD, compared with the emphysema phenotype, and women tend to have greater degrees of pulmonary function impairment when exposed to tobacco smoke, even after controlling for differences in height and weight.
“For the same amount of exposure to tobacco smoke, females are likely to develop more severe airflow limitation at an earlier age than males, and have more exacerbation,” Dr. Sodhi and colleagues wrote.
Both Dr. Silveyra and Dr. Sodhi said that reason why men and women differ in their physiological reactions to smoke are still unknown.
Sex differences in drug responses
There is only limited evidence to indicate that women and men respond differently to various therapeutic agents, but what is clear is that more research into this area is needed, Dr. Sodhi and Dr. Silveyra said.
For example, among the few studies that have documented sex differences, one showed no sex differences in the efficacy of salmeterol/fluticasone combination therapy for reducing exacerbations or improving quality of life, whereas another showed that women were more likely than men to experience COPD symptoms or exacerbations after stopping inhaled corticosteroids, Dr. Sodhi and colleagues noted.
Both Dr. Sodhi and Dr. Silveyra emphasized the need for clinical trials that study the effects of sex on treatment outcomes in COPD, which could lead to better, more personalized therapeutic regimens that take sex and gender into account.
Dr. Sodhi and colleagues offered the following advice to clinicians: “Interaction with female patients should take into account that their symptoms may not conform to traditionally accepted presentations. Challenges exist for female patients at all levels of health care interaction and as clinicians we need to acknowledge the bias and willfully work toward recognition and elimination of unconscious and conscious bias. Empowering our patients to have frank discussions with their health care team when they perceive bias is another step to help promote equity.”
The review by Dr. Sodhi and colleagues was supported by grants from the National Institutes of Health. Dr. Sodhi and Dr. Silveyra reported having no conflicts of interest to disclose.
When Sigmund Freud claimed that “anatomy is destiny” he was referring to anatomical sex as a determinant of personality traits. Expert consensus statements have previously offered some recommendations for managing these syndromes, but clinical data are scarce, so the present review “is intended to establish a starting point for future research,”
That notion has been widely discredited, but Freud appears to be inadvertently right in one respect: When it comes to chronic obstructive pulmonary disease (COPD), anatomy really is destiny, and sex may be as well, pulmonary researchers say.
There is a growing body of evidence to indicate that COPD affects men and women differently, and that men and women patients with COPD require different clinical management. Yet women are often underdiagnosed or misdiagnosed, partly because of poorly understood sex differences, but also because of cultural biases.
But plunging any farther into the weeds, it’s important to define terms. Although various investigators have used the terms “sex” and “gender” interchangeably, sex is the preferred term when referring to biological attributes of individual patients, while gender refers to personal identity.
These distinctions are important, contended Amik Sodhi, MBBS, MPH, from the division of allergy, pulmonology, and critical care medicine at the University of Wisconsin–Madison.
“Sex is essentially a biologic construct, so it’s got to do with the sex chromosomes, the genetics of that person, and it refers to the anatomic variations that can change susceptibility to different diseases,” she said in an interview.
An example of sex differences or “sexual dimorphism” can be found in a recent meta-analysis of sex-based genetic associations by Megan Hardin, MD, MPH from Brigham & Women’s Hospital in Boston and colleagues.
They reported that CELSR1, a gene involved in fetal lung development, was expressed more among women than among men and that a single nucleotide polymorphism in the gene was associated with COPD among women smokers, but not among men smokers.
The finding points to a potential risk locus for COPD in women, and could help shed light on sexual dimorphism in COPD, Dr. Hardin and colleagues said.
In contrast to sex, “gender is more of a psychosocial construct which can impact how diseases manifest themselves, how they are potentially managed, and what outcomes might occur for that particular disease,” Dr. Sodhi said.
She and her colleagues recently published a review of sex and gender in common lung disorders and sleep in the journal CHEST, where they wrote that the “influence of sex and gender is portrayed in epidemiological data, disease pathogenesis and pathophysiology, clinical manifestations, response to treatment, access to care, and health outcomes. Hence, sex and gender should be considered in all types of research, clinical practice and educational curricula.”
For example, as previously reported at the 2021 annual meeting of the American Thoracic Society, sex-specific differences in the severity of symptoms and prevalence of comorbidities in patients with COPD may point to different criteria for diagnosing cardiac comorbidities in women and men.
Those conclusions came from a retrospective analysis of data on 795 women and 1,251 men with GOLD (Global Initiative for Chronic Obstructive Lung Disease) class 1-3 disease.
The investigators looked at the patients’ clinical history, comorbidities, lung function, COPD Assessment Test scores, and modified Medical Research Council (mMRC) dyspnea score, and found significant differences between men and women for most functional parameters and comorbidities, and for CAT items of cough, phlegm, and energy.
In logistic regression analysis, predictors for cardiac disease in men were energy, mMRC score, smoking status, body mass index, age, and spirometric lung function, but in women only age was significantly predictive for cardiac disease.
An example of gender effects on COPD differences in men and women is the increase in cigarette advertising aimed at women in the 1960s and the advent of women-targeted brands such as Virginia Slims, which in turn lead to increased smoking rates among women. In addition, in the developing world, where the sex/gender gap in COPD is narrowing, women tend to have greater exposure to wood smoke and cooking fuels in unventilated or poorly ventilated spaces, compared with men.
Increasing incidence among women
According to the Centers for Disease Control and Prevention, chronic lower respiratory diseases, primarily COPD, were the fourth-leading cause of death in women in the United States in 2018, following only heart disease, cancer, and accidents/injuries.
And as a CDC analysis of data from the 2013 Behavioral Risk Factor Surveillance System showed, women were more likely to report being told by a physician that they had COPD than did men (6.6%, compared with 5.4%).
Dr. Sodhi and colleagues noted that, at all time points examined from 2005 to 2014, women had a higher proportion than men of COPD hospitalizations and in-hospital deaths. They also noted that female sex is associated with a threefold risk for severe early-onset COPD, and that women with COPD have lower diffusion capacity of lungs for carbon monoxide, despite having higher predicted forced expiratory volume in 1 second, compared with men.
“Historically, COPD wasn’t a disease that was so prevalent in women. It’s been in the past 20 years that the trends have changed,” said Patricia Silveyra, MSc, PhD, ATSF, associate professor of environmental and occupational health at Indiana University, Bloomington.
The increasing prevalence of COPD among women cannot be explained by smoking alone, she said in an interview.
“It used to be thought that it was because more women smoked, but actually a lot of women who don’t smoke can develop COPD, so it appears to be probably something environmental, but because it used to be a disease of older men, in the clinic there was also a bias to diagnose men with COPD, and women with asthma, so a lot of women went underdiagnosed,” Dr. Silveyra said.
In their review, Dr. Sodhi and colleagues noted that women with COPD “may be underdiagnosed as a result of having different symptoms from those classically recognized. Reasons for underdiagnosis or a delay in diagnosis may also be due to lack of a formal evaluation with spirometry, women seeking care later in the course of disease, physician bias, or associated fatigue or depression misdirecting diagnostic strategies. Underdiagnosis may be associated with psychological distress and worse health-related quality of life.”
Although the evidence is mixed, women tend to present more frequently with the chronic bronchitis phenotype of COPD, compared with the emphysema phenotype, and women tend to have greater degrees of pulmonary function impairment when exposed to tobacco smoke, even after controlling for differences in height and weight.
“For the same amount of exposure to tobacco smoke, females are likely to develop more severe airflow limitation at an earlier age than males, and have more exacerbation,” Dr. Sodhi and colleagues wrote.
Both Dr. Silveyra and Dr. Sodhi said that reason why men and women differ in their physiological reactions to smoke are still unknown.
Sex differences in drug responses
There is only limited evidence to indicate that women and men respond differently to various therapeutic agents, but what is clear is that more research into this area is needed, Dr. Sodhi and Dr. Silveyra said.
For example, among the few studies that have documented sex differences, one showed no sex differences in the efficacy of salmeterol/fluticasone combination therapy for reducing exacerbations or improving quality of life, whereas another showed that women were more likely than men to experience COPD symptoms or exacerbations after stopping inhaled corticosteroids, Dr. Sodhi and colleagues noted.
Both Dr. Sodhi and Dr. Silveyra emphasized the need for clinical trials that study the effects of sex on treatment outcomes in COPD, which could lead to better, more personalized therapeutic regimens that take sex and gender into account.
Dr. Sodhi and colleagues offered the following advice to clinicians: “Interaction with female patients should take into account that their symptoms may not conform to traditionally accepted presentations. Challenges exist for female patients at all levels of health care interaction and as clinicians we need to acknowledge the bias and willfully work toward recognition and elimination of unconscious and conscious bias. Empowering our patients to have frank discussions with their health care team when they perceive bias is another step to help promote equity.”
The review by Dr. Sodhi and colleagues was supported by grants from the National Institutes of Health. Dr. Sodhi and Dr. Silveyra reported having no conflicts of interest to disclose.
Contraception for women taking enzyme-inducing antiepileptics
Topiramate, introduced as an antiepileptic drug (AED), is currently most widely used for prevention of migraine headaches.
Because reproductive-aged women represent a population in which migraines are prevalent, clinicians need guidance to help women taking topiramate make sound contraceptive choices.
Several issues are relevant here. First, women who have migraines with aura should avoid estrogen-containing contraceptive pills, patches, and rings. Instead, progestin-only methods, including the contraceptive implant, may be recommended to patients with migraines.
Second, because topiramate, as with a number of other AEDs, is a teratogen, women using this medication need highly effective contraception. This consideration may also lead clinicians to recommend use of the implant in women with migraines.
Finally, topiramate, along with other AEDs (phenytoin, carbamazepine, barbiturates, primidone, and oxcarbazepine) induces hepatic enzymes, which results in reduced serum contraceptive steroid levels.
Because there is uncertainty regarding the degree to which the use of topiramate reduces serum levels of etonogestrel (the progestin released by the implant), investigators performed a prospective study to assess the pharmacokinetic impact of topiramate in women with the implant.
Ongoing users of contraceptive implants who agreed to use additional nonhormonal contraception were recruited to a 6-week study, during which they took topiramate and periodically had blood drawn.
Overall, use of topiramate was found to lower serum etonogestrel levels from baseline on a dose-related basis. At study completion, almost one-third of study participants were found to have serum progestin levels lower than the threshold associated with predictable ovulation suppression.
The results of this carefully conducted study support guidance from the Centers for Disease Control and Prevention that women seeking contraception and using topiramate or other enzyme-inducing AEDs should be encouraged to use intrauterine devices or injectable contraception. The contraceptive efficacy of these latter methods is not diminished by concomitant use of enzyme inducers.
I am Andrew Kaunitz. Please take care of yourself and each other.
Any views expressed above are the author’s own and do not necessarily reflect the views of WebMD or Medscape.
Andrew M. Kaunitz is a professor and Associate Chairman, department of obstetrics and gynecology, University of Florida, Jacksonville.
A version of this article first appeared on Medscape.com.
Topiramate, introduced as an antiepileptic drug (AED), is currently most widely used for prevention of migraine headaches.
Because reproductive-aged women represent a population in which migraines are prevalent, clinicians need guidance to help women taking topiramate make sound contraceptive choices.
Several issues are relevant here. First, women who have migraines with aura should avoid estrogen-containing contraceptive pills, patches, and rings. Instead, progestin-only methods, including the contraceptive implant, may be recommended to patients with migraines.
Second, because topiramate, as with a number of other AEDs, is a teratogen, women using this medication need highly effective contraception. This consideration may also lead clinicians to recommend use of the implant in women with migraines.
Finally, topiramate, along with other AEDs (phenytoin, carbamazepine, barbiturates, primidone, and oxcarbazepine) induces hepatic enzymes, which results in reduced serum contraceptive steroid levels.
Because there is uncertainty regarding the degree to which the use of topiramate reduces serum levels of etonogestrel (the progestin released by the implant), investigators performed a prospective study to assess the pharmacokinetic impact of topiramate in women with the implant.
Ongoing users of contraceptive implants who agreed to use additional nonhormonal contraception were recruited to a 6-week study, during which they took topiramate and periodically had blood drawn.
Overall, use of topiramate was found to lower serum etonogestrel levels from baseline on a dose-related basis. At study completion, almost one-third of study participants were found to have serum progestin levels lower than the threshold associated with predictable ovulation suppression.
The results of this carefully conducted study support guidance from the Centers for Disease Control and Prevention that women seeking contraception and using topiramate or other enzyme-inducing AEDs should be encouraged to use intrauterine devices or injectable contraception. The contraceptive efficacy of these latter methods is not diminished by concomitant use of enzyme inducers.
I am Andrew Kaunitz. Please take care of yourself and each other.
Any views expressed above are the author’s own and do not necessarily reflect the views of WebMD or Medscape.
Andrew M. Kaunitz is a professor and Associate Chairman, department of obstetrics and gynecology, University of Florida, Jacksonville.
A version of this article first appeared on Medscape.com.
Topiramate, introduced as an antiepileptic drug (AED), is currently most widely used for prevention of migraine headaches.
Because reproductive-aged women represent a population in which migraines are prevalent, clinicians need guidance to help women taking topiramate make sound contraceptive choices.
Several issues are relevant here. First, women who have migraines with aura should avoid estrogen-containing contraceptive pills, patches, and rings. Instead, progestin-only methods, including the contraceptive implant, may be recommended to patients with migraines.
Second, because topiramate, as with a number of other AEDs, is a teratogen, women using this medication need highly effective contraception. This consideration may also lead clinicians to recommend use of the implant in women with migraines.
Finally, topiramate, along with other AEDs (phenytoin, carbamazepine, barbiturates, primidone, and oxcarbazepine) induces hepatic enzymes, which results in reduced serum contraceptive steroid levels.
Because there is uncertainty regarding the degree to which the use of topiramate reduces serum levels of etonogestrel (the progestin released by the implant), investigators performed a prospective study to assess the pharmacokinetic impact of topiramate in women with the implant.
Ongoing users of contraceptive implants who agreed to use additional nonhormonal contraception were recruited to a 6-week study, during which they took topiramate and periodically had blood drawn.
Overall, use of topiramate was found to lower serum etonogestrel levels from baseline on a dose-related basis. At study completion, almost one-third of study participants were found to have serum progestin levels lower than the threshold associated with predictable ovulation suppression.
The results of this carefully conducted study support guidance from the Centers for Disease Control and Prevention that women seeking contraception and using topiramate or other enzyme-inducing AEDs should be encouraged to use intrauterine devices or injectable contraception. The contraceptive efficacy of these latter methods is not diminished by concomitant use of enzyme inducers.
I am Andrew Kaunitz. Please take care of yourself and each other.
Any views expressed above are the author’s own and do not necessarily reflect the views of WebMD or Medscape.
Andrew M. Kaunitz is a professor and Associate Chairman, department of obstetrics and gynecology, University of Florida, Jacksonville.
A version of this article first appeared on Medscape.com.