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azzed
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bullturds
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cocaine
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cocainees
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crackwhore
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cum
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cumsluted
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cunthunterer
cunthunteres
cunthuntering
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cunthunters
cunting
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cuntlicked
cuntlicker
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dagos
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damn
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damneder
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dickbag
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dickbags
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dickdippered
dickdipperer
dickdipperes
dickdippering
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dicker
dickes
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dickfaceed
dickfaceer
dickfacees
dickfaceing
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dickflippered
dickflipperer
dickflipperes
dickflippering
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dickheaded
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dickheadser
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dingleed
dingleer
dinglees
dingleing
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dipship
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dipshipes
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dizzyed
dizzyer
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dizzying
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dizzys
doggiestyleed
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dopeyer
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drunker
drunkes
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dumass
dumassed
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dumasses
dumassing
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dumasss
dumbass
dumbassed
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dumbassing
dumbassly
dumbasss
dummy
dummyed
dummyer
dummyes
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dyke
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dykeer
dykees
dykeing
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erotic
eroticed
eroticer
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erotics
extacy
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extacying
extacyly
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extasy
extasyed
extasyer
extasyes
extasying
extasyly
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facked
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faged
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fagged
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faggoted
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fagoted
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faiged
faiger
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faigts
fannybandit
fannybandited
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fannybandits
farted
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fartknockered
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fartly
farts
felch
felched
felcher
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fellateer
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fellateing
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fellatio
fellatioed
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feltched
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floozy
floozyed
floozyer
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foad
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freexes
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friggaer
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fuckined
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fuckinged
fuckinger
fuckinges
fuckinging
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fuckings
fuckining
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texarkana
Low HPV Vaccination in the United States Is a Public Health ‘Failure’
This transcript has been edited for clarity.
I would like to briefly discuss what I consider to be a very discouraging report and one that I believe we as an oncology society and, quite frankly, as a medical community need to deal with.
The manuscript I’m referring to is from the United States Department of Health and Human Services, titled, “Human Papillomavirus Vaccination Coverage in Children Ages 9-17 Years: United States, 2022.” This particular analysis looked at the coverage of both men and women — young boys and young girls, I would say — receiving at least one dose of the recommended human papillomavirus (HPV) vaccination.
Since 2006, girls have been recommended to receive HPV vaccination; for boys, it’s been since 2011. Certainly, the time period that we’re considering falls within the recommendations based on overwhelmingly positive data. Now, today, still, the recommendation is for more than one vaccine. Obviously, there may be evidence in the future that a single vaccination may be acceptable or appropriate. But today, it’s more than one.
In this particular analysis, they were looking at just a single vaccination. The vaccines have targeted young individuals, both male and female children aged 11-12 years, but it’s certainly acceptable to look starting at age 9.
What is the bottom line? At least one dose of the HPV vaccination was given to 38.6% of children aged 9-17 years in 2022. We are talking about a cancer-preventive vaccine, which on the basis of population-based data in the United States, but also in other countries, is incredibly effective in preventing HPV-associated cancers. This not only includes cervical cancer, but also a large percentage of head and neck cancers.
For this vaccine, which is incredibly safe and incredibly effective, in this country, only 38.6% have received even a single dose. It is noted that the individuals with private insurance had a higher rate, at 41.5%, than individuals with no insurance, at only 20.7%.
In my opinion, this is clearly a failure of our public health establishment at all levels. My own focus has been in gynecologic cancers. I’ve seen young women with advanced cervical cancer, and this is a disease we can prevent. Yet, this is where we are.
For those of you who are interested in cancer prevention or public health, I think this is a very sobering statistic. It’s my plea and my hope that we can, as a society, somehow do something about it.
I thank you for listening. I would encourage you to think about this question if you’re in this area.
Dr. Markman, professor, Department of Medical Oncology and Therapeutics Research, City of Hope, Duarte, California, and president of Medicine & Science, City of Hope Atlanta, Chicago, and Phoenix, disclosed ties with GlaxoSmithKline and AstraZeneca.
A version of this article appeared on Medscape.com.
This transcript has been edited for clarity.
I would like to briefly discuss what I consider to be a very discouraging report and one that I believe we as an oncology society and, quite frankly, as a medical community need to deal with.
The manuscript I’m referring to is from the United States Department of Health and Human Services, titled, “Human Papillomavirus Vaccination Coverage in Children Ages 9-17 Years: United States, 2022.” This particular analysis looked at the coverage of both men and women — young boys and young girls, I would say — receiving at least one dose of the recommended human papillomavirus (HPV) vaccination.
Since 2006, girls have been recommended to receive HPV vaccination; for boys, it’s been since 2011. Certainly, the time period that we’re considering falls within the recommendations based on overwhelmingly positive data. Now, today, still, the recommendation is for more than one vaccine. Obviously, there may be evidence in the future that a single vaccination may be acceptable or appropriate. But today, it’s more than one.
In this particular analysis, they were looking at just a single vaccination. The vaccines have targeted young individuals, both male and female children aged 11-12 years, but it’s certainly acceptable to look starting at age 9.
What is the bottom line? At least one dose of the HPV vaccination was given to 38.6% of children aged 9-17 years in 2022. We are talking about a cancer-preventive vaccine, which on the basis of population-based data in the United States, but also in other countries, is incredibly effective in preventing HPV-associated cancers. This not only includes cervical cancer, but also a large percentage of head and neck cancers.
For this vaccine, which is incredibly safe and incredibly effective, in this country, only 38.6% have received even a single dose. It is noted that the individuals with private insurance had a higher rate, at 41.5%, than individuals with no insurance, at only 20.7%.
In my opinion, this is clearly a failure of our public health establishment at all levels. My own focus has been in gynecologic cancers. I’ve seen young women with advanced cervical cancer, and this is a disease we can prevent. Yet, this is where we are.
For those of you who are interested in cancer prevention or public health, I think this is a very sobering statistic. It’s my plea and my hope that we can, as a society, somehow do something about it.
I thank you for listening. I would encourage you to think about this question if you’re in this area.
Dr. Markman, professor, Department of Medical Oncology and Therapeutics Research, City of Hope, Duarte, California, and president of Medicine & Science, City of Hope Atlanta, Chicago, and Phoenix, disclosed ties with GlaxoSmithKline and AstraZeneca.
A version of this article appeared on Medscape.com.
This transcript has been edited for clarity.
I would like to briefly discuss what I consider to be a very discouraging report and one that I believe we as an oncology society and, quite frankly, as a medical community need to deal with.
The manuscript I’m referring to is from the United States Department of Health and Human Services, titled, “Human Papillomavirus Vaccination Coverage in Children Ages 9-17 Years: United States, 2022.” This particular analysis looked at the coverage of both men and women — young boys and young girls, I would say — receiving at least one dose of the recommended human papillomavirus (HPV) vaccination.
Since 2006, girls have been recommended to receive HPV vaccination; for boys, it’s been since 2011. Certainly, the time period that we’re considering falls within the recommendations based on overwhelmingly positive data. Now, today, still, the recommendation is for more than one vaccine. Obviously, there may be evidence in the future that a single vaccination may be acceptable or appropriate. But today, it’s more than one.
In this particular analysis, they were looking at just a single vaccination. The vaccines have targeted young individuals, both male and female children aged 11-12 years, but it’s certainly acceptable to look starting at age 9.
What is the bottom line? At least one dose of the HPV vaccination was given to 38.6% of children aged 9-17 years in 2022. We are talking about a cancer-preventive vaccine, which on the basis of population-based data in the United States, but also in other countries, is incredibly effective in preventing HPV-associated cancers. This not only includes cervical cancer, but also a large percentage of head and neck cancers.
For this vaccine, which is incredibly safe and incredibly effective, in this country, only 38.6% have received even a single dose. It is noted that the individuals with private insurance had a higher rate, at 41.5%, than individuals with no insurance, at only 20.7%.
In my opinion, this is clearly a failure of our public health establishment at all levels. My own focus has been in gynecologic cancers. I’ve seen young women with advanced cervical cancer, and this is a disease we can prevent. Yet, this is where we are.
For those of you who are interested in cancer prevention or public health, I think this is a very sobering statistic. It’s my plea and my hope that we can, as a society, somehow do something about it.
I thank you for listening. I would encourage you to think about this question if you’re in this area.
Dr. Markman, professor, Department of Medical Oncology and Therapeutics Research, City of Hope, Duarte, California, and president of Medicine & Science, City of Hope Atlanta, Chicago, and Phoenix, disclosed ties with GlaxoSmithKline and AstraZeneca.
A version of this article appeared on Medscape.com.
Gender and Sports: Can Science Enable Fair Competition?
The allegations against Algerian boxer Imane Khelif at the Paris Olympics raised the questions of intersexuality and its implications in competitive sports. This news organization has decided to delve into the topic to assist doctors who suspect a similar condition in their patients. No certain clinical data about Ms. Khelif have been made public, so this article does not concern the boxer but rather takes inspiration from the media controversy.
What Is Intersexuality?
Intersexuality encompasses a spectrum of variations in sexual development that lead to the simultaneous presence of typical male and female characteristics. As reiterated by the United Nations Office of the High Commissioner for Human Rights, the medical definition does not affect the patient’s self-identification of gender or sexual orientation.
“The percentage of people who fall within the intersexuality spectrum is less than 0.5 per thousand of the general population, but there are no precise statistics, given the difficulty of definition,” said Roberto Lala, MD, pediatric endocrinologist and president of the Federation of Rare Childhood Diseases.
Indeed, there is not only a strict definition of intersexuality that involves a significant presence of these mixed physical characteristics in a way that conditions the self-image of the subject but also a broad definition, said Dr. Lala. “For example, clitoral hypertrophy in a female otherwise conforming to the female gender, which does not raise doubts about identity,” he said.
Chromosomes, Genes, and Hormones
testosterone and other factors. For this to happen, testosterone must be produced during embryonic development, and it must function properly,” said Paolo Moghetti, full professor of endocrinology at the University of Verona, Italy.
The protein encoded by SRY, which is located on the Y chromosome, determines the development of the testicles from undifferentiated tissue of the embryonic gonads. The testicles of the embryo then produce testosterone. The absence of the Y chromosome is a common characteristic of most female individuals. However, there are individuals with a female phenotype who have X and Y chromosomes but lack SRY or have a variant of it that is not entirely functional.
Numerous other chromosomal or genetic variations can lead to alterations in sexual differentiation. “In phenotypically male adult subjects (with a chromosomal makeup of 46XY) with complete androgen insensitivity (so-called Morris syndrome), testosterone levels in the blood are elevated, above normal even for a male, but the hormone is totally ineffective, and the phenotype is totally female at birth, with completely female development of secondary sexual characteristics at puberty,” said Dr. Moghetti.
This means that affected individuals have well-developed breasts and a complete lack or extremely reduced presence of hair, including underarm and pubic hair. Menstruation is also completely absent because there is no uterus, and there are testes, not visible because they are considered in the abdomen.
“There are syndromes that are currently considered congenital but not genetic, of which a genetic origin will probably be identified in the future,” said Dr. Lala.
Some variations in sexual development can be diagnosed prenatally, such as an alteration of the number of sex chromosomes or a discordance between the morphologic characteristics highlighted by ultrasound and the genotype detected by amniocentesis. Some variations are evident at birth because of atypical anatomical characteristics. Others are diagnosed during puberty or later in adulthood, in the presence of infertility. The Italian National Institute of Health details these variations on its website, describing the characteristics that determine diagnosis and treatment.
Pathologies or Variations?
Some anomalies in sexual development negatively affect the patient’s physical health. One example is congenital adrenal hyperplasia. “It results from an inherited defect of the adrenal glands, which reduces cortisol production while increasing testosterone production,” said Dr. Lala. “In addition to the appearance of male characteristics in females, in more severe forms, it carries the risk of collapse and shock and requires pharmacological treatment.” It is undoubtedly a pathology.
Other variations in sexual characteristics do not affect the patient’s physical health negatively. They may, however, have a psychologic effect, sometimes a significant one, because of the lack of social acceptance of a person who cannot be classified within the binary classification of sexes.
“Conditions in which mixed male and female aspects are clearly evident have been and are still pathologized by the family, the treating physician, and society,” said Dr. Lala. “In the late 1970s, when a child was born with intersexual anatomical characteristics, it was common practice to surgically intervene, making them female, because it was technically easier.”
Over the years, patients who, as they grew up, were dissatisfied with the solution adopted at birth began to make their voices heard, Dr. Lala added. Scientific societies and international organizations have spoken out against subjecting intersexual newborns to surgical interventions that are not medically necessary. “Nowadays, decisions are made on a case-by-case basis, taking into account the families’ wishes. Interventions are justified with medical reasons, which are often very nuanced,” Dr. Lala concluded.
Implications for Sports
Traditionally, athletes participating in competitions in certain sports have been divided into male and female categories to ensure a certain equity and uniformity in performance. Over the years, the emergence of new information about sexual development has made it necessary to update the criteria used in this division.
The main factor responsible for the performance diversity between males and females is the action of testosterone on the male and female organism. “Testosterone has important effects on muscle mass and enhances training results,” said Dr. Moghetti. “As a demonstration of this fact, before puberty, the best performances in athletics or swimming by males and females are similar, then males gain a significant advantage of around 10%-20%.”
A few years ago, the World Athletics Federation conducted widespread screening of athletes participating in its world championships. “It identified a small group of individuals with potentially abnormal testosterone levels for the female sex,” said Dr. Moghetti. “Some were found to be doping, others had genetic defects, and for some, an interpretation was not even possible.”
Some of the individuals had a male genotype but a defect in 5-alpha-reductase, an enzyme essential for the formation of male genitals and hair growth. An athlete with these characteristics, assigned female sex at birth, has a male level of testosterone that stimulates the accumulation of muscle mass, Dr. Moghetti explained. Therefore, the individual has a considerable advantage in performances influenced by this hormone.
“In the end, the Federation decided to set limits on the testosterone levels of athletes participating in certain types of races, especially those in middle distance, that appeared to be more sensitive to differences in hormone levels,” said Dr. Moghetti. “The limitation does not apply to athletes with Morris syndrome, ie, with a male genotype and complete resistance to testosterone, for whom the high level of this hormone does not provide any advantage.” Given the complexity of the problem, he hopes for a case-by-case policy that considers the needs of patients with genetic alterations and those of athletes who have to compete with them.
Not the First Time
A recent incident underscored the difficulty of regulating such complex issues. The World Athletics Federation excluded South African middle-distance runner Caster Semenya from competitions years ago because of excessively high testosterone levels.
“The Federation’s regulations recommend that athletes in these cases reduce hormone levels to values below the threshold of 5 nmol/L of blood for a period of at least 6 months before the race by using hormonal contraceptives. The use of such drugs does not pose a health risk, as they are substances normally taken by women for contraception purposes,” said Amelia Filippelli, a pharmacologist at the University of Salerno in Italy. The South African middle-distance runner refused the drug and appealed to the Court of Arbitration for Sport and later to the Swiss Federal Court. Both rejected her appeal. Finally, Ms. Semenya appealed to the European Court of Human Rights, which in 2023 recognized a violation of her rights but does not have the authority to order a change in the Federation’s regulations.
Beyond the ideologic positions of nonexperts, therefore, the issue is still the subject of debate in the scientific community, which is evaluating not only its medical aspects but also its ethical implications.
This story was translated from Univadis Italy, which is part of the Medscape professional network, using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
The allegations against Algerian boxer Imane Khelif at the Paris Olympics raised the questions of intersexuality and its implications in competitive sports. This news organization has decided to delve into the topic to assist doctors who suspect a similar condition in their patients. No certain clinical data about Ms. Khelif have been made public, so this article does not concern the boxer but rather takes inspiration from the media controversy.
What Is Intersexuality?
Intersexuality encompasses a spectrum of variations in sexual development that lead to the simultaneous presence of typical male and female characteristics. As reiterated by the United Nations Office of the High Commissioner for Human Rights, the medical definition does not affect the patient’s self-identification of gender or sexual orientation.
“The percentage of people who fall within the intersexuality spectrum is less than 0.5 per thousand of the general population, but there are no precise statistics, given the difficulty of definition,” said Roberto Lala, MD, pediatric endocrinologist and president of the Federation of Rare Childhood Diseases.
Indeed, there is not only a strict definition of intersexuality that involves a significant presence of these mixed physical characteristics in a way that conditions the self-image of the subject but also a broad definition, said Dr. Lala. “For example, clitoral hypertrophy in a female otherwise conforming to the female gender, which does not raise doubts about identity,” he said.
Chromosomes, Genes, and Hormones
testosterone and other factors. For this to happen, testosterone must be produced during embryonic development, and it must function properly,” said Paolo Moghetti, full professor of endocrinology at the University of Verona, Italy.
The protein encoded by SRY, which is located on the Y chromosome, determines the development of the testicles from undifferentiated tissue of the embryonic gonads. The testicles of the embryo then produce testosterone. The absence of the Y chromosome is a common characteristic of most female individuals. However, there are individuals with a female phenotype who have X and Y chromosomes but lack SRY or have a variant of it that is not entirely functional.
Numerous other chromosomal or genetic variations can lead to alterations in sexual differentiation. “In phenotypically male adult subjects (with a chromosomal makeup of 46XY) with complete androgen insensitivity (so-called Morris syndrome), testosterone levels in the blood are elevated, above normal even for a male, but the hormone is totally ineffective, and the phenotype is totally female at birth, with completely female development of secondary sexual characteristics at puberty,” said Dr. Moghetti.
This means that affected individuals have well-developed breasts and a complete lack or extremely reduced presence of hair, including underarm and pubic hair. Menstruation is also completely absent because there is no uterus, and there are testes, not visible because they are considered in the abdomen.
“There are syndromes that are currently considered congenital but not genetic, of which a genetic origin will probably be identified in the future,” said Dr. Lala.
Some variations in sexual development can be diagnosed prenatally, such as an alteration of the number of sex chromosomes or a discordance between the morphologic characteristics highlighted by ultrasound and the genotype detected by amniocentesis. Some variations are evident at birth because of atypical anatomical characteristics. Others are diagnosed during puberty or later in adulthood, in the presence of infertility. The Italian National Institute of Health details these variations on its website, describing the characteristics that determine diagnosis and treatment.
Pathologies or Variations?
Some anomalies in sexual development negatively affect the patient’s physical health. One example is congenital adrenal hyperplasia. “It results from an inherited defect of the adrenal glands, which reduces cortisol production while increasing testosterone production,” said Dr. Lala. “In addition to the appearance of male characteristics in females, in more severe forms, it carries the risk of collapse and shock and requires pharmacological treatment.” It is undoubtedly a pathology.
Other variations in sexual characteristics do not affect the patient’s physical health negatively. They may, however, have a psychologic effect, sometimes a significant one, because of the lack of social acceptance of a person who cannot be classified within the binary classification of sexes.
“Conditions in which mixed male and female aspects are clearly evident have been and are still pathologized by the family, the treating physician, and society,” said Dr. Lala. “In the late 1970s, when a child was born with intersexual anatomical characteristics, it was common practice to surgically intervene, making them female, because it was technically easier.”
Over the years, patients who, as they grew up, were dissatisfied with the solution adopted at birth began to make their voices heard, Dr. Lala added. Scientific societies and international organizations have spoken out against subjecting intersexual newborns to surgical interventions that are not medically necessary. “Nowadays, decisions are made on a case-by-case basis, taking into account the families’ wishes. Interventions are justified with medical reasons, which are often very nuanced,” Dr. Lala concluded.
Implications for Sports
Traditionally, athletes participating in competitions in certain sports have been divided into male and female categories to ensure a certain equity and uniformity in performance. Over the years, the emergence of new information about sexual development has made it necessary to update the criteria used in this division.
The main factor responsible for the performance diversity between males and females is the action of testosterone on the male and female organism. “Testosterone has important effects on muscle mass and enhances training results,” said Dr. Moghetti. “As a demonstration of this fact, before puberty, the best performances in athletics or swimming by males and females are similar, then males gain a significant advantage of around 10%-20%.”
A few years ago, the World Athletics Federation conducted widespread screening of athletes participating in its world championships. “It identified a small group of individuals with potentially abnormal testosterone levels for the female sex,” said Dr. Moghetti. “Some were found to be doping, others had genetic defects, and for some, an interpretation was not even possible.”
Some of the individuals had a male genotype but a defect in 5-alpha-reductase, an enzyme essential for the formation of male genitals and hair growth. An athlete with these characteristics, assigned female sex at birth, has a male level of testosterone that stimulates the accumulation of muscle mass, Dr. Moghetti explained. Therefore, the individual has a considerable advantage in performances influenced by this hormone.
“In the end, the Federation decided to set limits on the testosterone levels of athletes participating in certain types of races, especially those in middle distance, that appeared to be more sensitive to differences in hormone levels,” said Dr. Moghetti. “The limitation does not apply to athletes with Morris syndrome, ie, with a male genotype and complete resistance to testosterone, for whom the high level of this hormone does not provide any advantage.” Given the complexity of the problem, he hopes for a case-by-case policy that considers the needs of patients with genetic alterations and those of athletes who have to compete with them.
Not the First Time
A recent incident underscored the difficulty of regulating such complex issues. The World Athletics Federation excluded South African middle-distance runner Caster Semenya from competitions years ago because of excessively high testosterone levels.
“The Federation’s regulations recommend that athletes in these cases reduce hormone levels to values below the threshold of 5 nmol/L of blood for a period of at least 6 months before the race by using hormonal contraceptives. The use of such drugs does not pose a health risk, as they are substances normally taken by women for contraception purposes,” said Amelia Filippelli, a pharmacologist at the University of Salerno in Italy. The South African middle-distance runner refused the drug and appealed to the Court of Arbitration for Sport and later to the Swiss Federal Court. Both rejected her appeal. Finally, Ms. Semenya appealed to the European Court of Human Rights, which in 2023 recognized a violation of her rights but does not have the authority to order a change in the Federation’s regulations.
Beyond the ideologic positions of nonexperts, therefore, the issue is still the subject of debate in the scientific community, which is evaluating not only its medical aspects but also its ethical implications.
This story was translated from Univadis Italy, which is part of the Medscape professional network, using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
The allegations against Algerian boxer Imane Khelif at the Paris Olympics raised the questions of intersexuality and its implications in competitive sports. This news organization has decided to delve into the topic to assist doctors who suspect a similar condition in their patients. No certain clinical data about Ms. Khelif have been made public, so this article does not concern the boxer but rather takes inspiration from the media controversy.
What Is Intersexuality?
Intersexuality encompasses a spectrum of variations in sexual development that lead to the simultaneous presence of typical male and female characteristics. As reiterated by the United Nations Office of the High Commissioner for Human Rights, the medical definition does not affect the patient’s self-identification of gender or sexual orientation.
“The percentage of people who fall within the intersexuality spectrum is less than 0.5 per thousand of the general population, but there are no precise statistics, given the difficulty of definition,” said Roberto Lala, MD, pediatric endocrinologist and president of the Federation of Rare Childhood Diseases.
Indeed, there is not only a strict definition of intersexuality that involves a significant presence of these mixed physical characteristics in a way that conditions the self-image of the subject but also a broad definition, said Dr. Lala. “For example, clitoral hypertrophy in a female otherwise conforming to the female gender, which does not raise doubts about identity,” he said.
Chromosomes, Genes, and Hormones
testosterone and other factors. For this to happen, testosterone must be produced during embryonic development, and it must function properly,” said Paolo Moghetti, full professor of endocrinology at the University of Verona, Italy.
The protein encoded by SRY, which is located on the Y chromosome, determines the development of the testicles from undifferentiated tissue of the embryonic gonads. The testicles of the embryo then produce testosterone. The absence of the Y chromosome is a common characteristic of most female individuals. However, there are individuals with a female phenotype who have X and Y chromosomes but lack SRY or have a variant of it that is not entirely functional.
Numerous other chromosomal or genetic variations can lead to alterations in sexual differentiation. “In phenotypically male adult subjects (with a chromosomal makeup of 46XY) with complete androgen insensitivity (so-called Morris syndrome), testosterone levels in the blood are elevated, above normal even for a male, but the hormone is totally ineffective, and the phenotype is totally female at birth, with completely female development of secondary sexual characteristics at puberty,” said Dr. Moghetti.
This means that affected individuals have well-developed breasts and a complete lack or extremely reduced presence of hair, including underarm and pubic hair. Menstruation is also completely absent because there is no uterus, and there are testes, not visible because they are considered in the abdomen.
“There are syndromes that are currently considered congenital but not genetic, of which a genetic origin will probably be identified in the future,” said Dr. Lala.
Some variations in sexual development can be diagnosed prenatally, such as an alteration of the number of sex chromosomes or a discordance between the morphologic characteristics highlighted by ultrasound and the genotype detected by amniocentesis. Some variations are evident at birth because of atypical anatomical characteristics. Others are diagnosed during puberty or later in adulthood, in the presence of infertility. The Italian National Institute of Health details these variations on its website, describing the characteristics that determine diagnosis and treatment.
Pathologies or Variations?
Some anomalies in sexual development negatively affect the patient’s physical health. One example is congenital adrenal hyperplasia. “It results from an inherited defect of the adrenal glands, which reduces cortisol production while increasing testosterone production,” said Dr. Lala. “In addition to the appearance of male characteristics in females, in more severe forms, it carries the risk of collapse and shock and requires pharmacological treatment.” It is undoubtedly a pathology.
Other variations in sexual characteristics do not affect the patient’s physical health negatively. They may, however, have a psychologic effect, sometimes a significant one, because of the lack of social acceptance of a person who cannot be classified within the binary classification of sexes.
“Conditions in which mixed male and female aspects are clearly evident have been and are still pathologized by the family, the treating physician, and society,” said Dr. Lala. “In the late 1970s, when a child was born with intersexual anatomical characteristics, it was common practice to surgically intervene, making them female, because it was technically easier.”
Over the years, patients who, as they grew up, were dissatisfied with the solution adopted at birth began to make their voices heard, Dr. Lala added. Scientific societies and international organizations have spoken out against subjecting intersexual newborns to surgical interventions that are not medically necessary. “Nowadays, decisions are made on a case-by-case basis, taking into account the families’ wishes. Interventions are justified with medical reasons, which are often very nuanced,” Dr. Lala concluded.
Implications for Sports
Traditionally, athletes participating in competitions in certain sports have been divided into male and female categories to ensure a certain equity and uniformity in performance. Over the years, the emergence of new information about sexual development has made it necessary to update the criteria used in this division.
The main factor responsible for the performance diversity between males and females is the action of testosterone on the male and female organism. “Testosterone has important effects on muscle mass and enhances training results,” said Dr. Moghetti. “As a demonstration of this fact, before puberty, the best performances in athletics or swimming by males and females are similar, then males gain a significant advantage of around 10%-20%.”
A few years ago, the World Athletics Federation conducted widespread screening of athletes participating in its world championships. “It identified a small group of individuals with potentially abnormal testosterone levels for the female sex,” said Dr. Moghetti. “Some were found to be doping, others had genetic defects, and for some, an interpretation was not even possible.”
Some of the individuals had a male genotype but a defect in 5-alpha-reductase, an enzyme essential for the formation of male genitals and hair growth. An athlete with these characteristics, assigned female sex at birth, has a male level of testosterone that stimulates the accumulation of muscle mass, Dr. Moghetti explained. Therefore, the individual has a considerable advantage in performances influenced by this hormone.
“In the end, the Federation decided to set limits on the testosterone levels of athletes participating in certain types of races, especially those in middle distance, that appeared to be more sensitive to differences in hormone levels,” said Dr. Moghetti. “The limitation does not apply to athletes with Morris syndrome, ie, with a male genotype and complete resistance to testosterone, for whom the high level of this hormone does not provide any advantage.” Given the complexity of the problem, he hopes for a case-by-case policy that considers the needs of patients with genetic alterations and those of athletes who have to compete with them.
Not the First Time
A recent incident underscored the difficulty of regulating such complex issues. The World Athletics Federation excluded South African middle-distance runner Caster Semenya from competitions years ago because of excessively high testosterone levels.
“The Federation’s regulations recommend that athletes in these cases reduce hormone levels to values below the threshold of 5 nmol/L of blood for a period of at least 6 months before the race by using hormonal contraceptives. The use of such drugs does not pose a health risk, as they are substances normally taken by women for contraception purposes,” said Amelia Filippelli, a pharmacologist at the University of Salerno in Italy. The South African middle-distance runner refused the drug and appealed to the Court of Arbitration for Sport and later to the Swiss Federal Court. Both rejected her appeal. Finally, Ms. Semenya appealed to the European Court of Human Rights, which in 2023 recognized a violation of her rights but does not have the authority to order a change in the Federation’s regulations.
Beyond the ideologic positions of nonexperts, therefore, the issue is still the subject of debate in the scientific community, which is evaluating not only its medical aspects but also its ethical implications.
This story was translated from Univadis Italy, which is part of the Medscape professional network, using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
Uterus Transplants in Women With Uterine-Factor Infertility Show High Rate of Live Births
TOPLINE:
Uterus transplants in women with absolute uterine-factor infertility resulted in a 70% success rate of women later giving birth.
METHODOLOGY:
- The study included 20 women with uterine-factor infertility, a condition in which women do not have a uterus or have one that is not functional; each patient had at least one functioning ovary and uterine abnormalities.
- All patients underwent womb transplantation at a large US specialized care center between 2016 and 2019.
- The transplant was performed using grafts from 18 living donors and two deceased donors.
- Patients received anti-rejection medication until the transplanted uterus was removed following one or two live births or graft failure.
- Researchers measured uterus graft survival and subsequent live births.
TAKEAWAY:
- Out of the 20 participants, 14 (70%) had successful uterus transplants and all 14 gave birth to at least one healthy infant.
- Half of the successful pregnancies had complications, which included gestational hypertension (14%), cervical insufficiency (14%), and preterm labor (14%).
- None of the 16 live-born infants had congenital malformations, and no developmental delays were observed as of May 2024.
- Four of the 18 living donors experienced grade 3 complications, including ureteral obstruction and thermal injury to the ureters.
IN PRACTICE:
“Uterus transplant was technically feasible and was associated with a high live birth rate following successful graft survival,” wrote the authors of the study. “Adverse events were common, with medical and surgical risks affecting recipients as well as donors.”
SOURCE:
The study was led by Giuliano Testa, MD, MBA, of Baylor University Medical Center in Dallas, Texas, and was published online in JAMA Network.
LIMITATIONS:
The findings are based on data from a single center. The sample size was small. The high cost of uterus transplants limits generalizability.
DISCLOSURES:
No disclosures were reported.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
Uterus transplants in women with absolute uterine-factor infertility resulted in a 70% success rate of women later giving birth.
METHODOLOGY:
- The study included 20 women with uterine-factor infertility, a condition in which women do not have a uterus or have one that is not functional; each patient had at least one functioning ovary and uterine abnormalities.
- All patients underwent womb transplantation at a large US specialized care center between 2016 and 2019.
- The transplant was performed using grafts from 18 living donors and two deceased donors.
- Patients received anti-rejection medication until the transplanted uterus was removed following one or two live births or graft failure.
- Researchers measured uterus graft survival and subsequent live births.
TAKEAWAY:
- Out of the 20 participants, 14 (70%) had successful uterus transplants and all 14 gave birth to at least one healthy infant.
- Half of the successful pregnancies had complications, which included gestational hypertension (14%), cervical insufficiency (14%), and preterm labor (14%).
- None of the 16 live-born infants had congenital malformations, and no developmental delays were observed as of May 2024.
- Four of the 18 living donors experienced grade 3 complications, including ureteral obstruction and thermal injury to the ureters.
IN PRACTICE:
“Uterus transplant was technically feasible and was associated with a high live birth rate following successful graft survival,” wrote the authors of the study. “Adverse events were common, with medical and surgical risks affecting recipients as well as donors.”
SOURCE:
The study was led by Giuliano Testa, MD, MBA, of Baylor University Medical Center in Dallas, Texas, and was published online in JAMA Network.
LIMITATIONS:
The findings are based on data from a single center. The sample size was small. The high cost of uterus transplants limits generalizability.
DISCLOSURES:
No disclosures were reported.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
Uterus transplants in women with absolute uterine-factor infertility resulted in a 70% success rate of women later giving birth.
METHODOLOGY:
- The study included 20 women with uterine-factor infertility, a condition in which women do not have a uterus or have one that is not functional; each patient had at least one functioning ovary and uterine abnormalities.
- All patients underwent womb transplantation at a large US specialized care center between 2016 and 2019.
- The transplant was performed using grafts from 18 living donors and two deceased donors.
- Patients received anti-rejection medication until the transplanted uterus was removed following one or two live births or graft failure.
- Researchers measured uterus graft survival and subsequent live births.
TAKEAWAY:
- Out of the 20 participants, 14 (70%) had successful uterus transplants and all 14 gave birth to at least one healthy infant.
- Half of the successful pregnancies had complications, which included gestational hypertension (14%), cervical insufficiency (14%), and preterm labor (14%).
- None of the 16 live-born infants had congenital malformations, and no developmental delays were observed as of May 2024.
- Four of the 18 living donors experienced grade 3 complications, including ureteral obstruction and thermal injury to the ureters.
IN PRACTICE:
“Uterus transplant was technically feasible and was associated with a high live birth rate following successful graft survival,” wrote the authors of the study. “Adverse events were common, with medical and surgical risks affecting recipients as well as donors.”
SOURCE:
The study was led by Giuliano Testa, MD, MBA, of Baylor University Medical Center in Dallas, Texas, and was published online in JAMA Network.
LIMITATIONS:
The findings are based on data from a single center. The sample size was small. The high cost of uterus transplants limits generalizability.
DISCLOSURES:
No disclosures were reported.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
Rural Women Face Greater Challenges in Perimenopause
Women in the perimenopausal period who live in rural areas have a higher prevalence of symptoms typical of this period and a poorer health-related quality of life than women living in urban areas, according to a cross-sectional study that was conducted in Spain.
Cristina Llaneza Suárez, a specialist in family and community medicine and the lead author of the study, told this news organization that women living in rural areas face greater difficulties with access to healthcare services, employment, and transportation and a heavier burden of caregiving. She mentioned that these barriers “can represent an added challenge during the perimenopausal stage, when significant life changes generally occur for all women.” The challenges may lead to “poorer health-related quality of life during perimenopause, compared with women living in urban areas.”
The research group led by Dr. Llaneza aimed to test the hypothesis that sociodemographic characteristics influence symptoms and quality of life in women in perimenopause. They enrolled 270 women aged 45-55 years from eight autonomous communities in Spain who had variability in their menstrual cycles (lasting more than 7 days or amenorrhea greater than 60 days but less than a year).
This cross-sectional study was conducted from December 2019 to April 2023, using the short version of the Cervantes scale to assess health-related quality of life and the Beck Depression Inventory to evaluate associated depressive symptoms.
Among the main findings of the study was that sociocultural factors can influence the perception of perimenopausal symptoms. Living in rural areas has a negative effect on health-related quality of life scales, and this finding is consistent with those of previous studies conducted on women in India, Turkey, Poland, and Peru.
In addition, the selected sample of women experiencing changes in their menstrual cycles and residing in rural areas showed a high prevalence of hot flashes (70% overall and 80% in rural areas) and a poorer quality of life in women with obesity.
“It is striking that, although there is a worse perception of quality of life during perimenopause in women living in rural areas, the proportion of women experiencing some degree of depressive symptoms, according to the Beck inventory, was similar to that of women residing in urban areas,” said Dr. Llaneza. She noted that “no worse scores were observed in sexuality or in the couple relationship.”
Rural Physicians’ Role
Women in the perimenopausal period face significant challenges resulting from inadequate access to healthcare services and limited awareness about menopause. In many countries, this topic is still taboo, both in the family environment and in workplaces and health centers.
Dr. Llaneza mentioned that when she began her training as a primary care physician in a rural population, she witnessed firsthand some of the barriers that women in this age group face, such as limited access to healthcare due to a lack of public transportation. She added that, coupled with this challenge, “there are no regular public transport services that allow independent access for patients, and many [women] lack a driver’s license, making them dependent on others to receive healthcare.” Another important point that she identified was the lack of health education in rural populations, which leads to a minimization of perimenopausal symptoms and causes delays in prevention and early detection.
According to the World Health Organization, healthcare professionals often lack the necessary training to recognize and treat the symptoms of perimenopause and postmenopause. This situation, coupled with the limited attention given to the sexual well-being of menopausal women, contributes to gynecological problems and risks for sexually transmitted infections in this population. The absence of specific health policies and funding for menopause exacerbates the situation, particularly in regions where other health needs compete for limited resources.
Dr. Llaneza noted that primary care physicians in rural areas are responsible for leading primary prevention actions through community interventions that contribute to improving health. Community physicians in rural areas have a lower patient load than urban physicians do. Therefore, “this allows for a more thorough management and closer monitoring of these conditions, which highlights the importance of prevention of perimenopausal symptoms and community education,” she said.
An important goal in improving the quality of life of women in the perimenopausal period is reducing symptoms. Hormone replacement therapy is the cornerstone of treatment, along with nonhormonal therapies such as the use of isoflavones. However, the aforementioned barriers lead to a delay in initiating effective treatment.
Dr. Llaneza added that the main limitation that she encountered during her clinical practice in rural areas regarding the initiation of hormonal therapy was “the reluctance of certain professionals to start it, as they consider that these drugs should be prescribed by menopause specialists because of potential side effects and the increased risk for developing breast cancer.”
Call for Training
Dr. Llaneza and her research team emphasized the need for further research on new drugs for controlling vasomotor symptoms, expressing their interest in conducting additional studies. “We would like to conduct a study on the use of these therapies in perimenopausal and postmenopausal women residing in rural areas.
“We believe that our data may be of interest to healthcare authorities seeking to combat population exodus in rural areas,” they wrote. In addition, they recommended additional training for rural primary care physicians on perimenopause and menopause topics regarding prevention, management, and access, as well as further awareness about preventing depressive symptoms in this population.
Dr. Llaneza declared that she has no relevant financial relationships.
This story was translated from the Medscape Spanish edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
Women in the perimenopausal period who live in rural areas have a higher prevalence of symptoms typical of this period and a poorer health-related quality of life than women living in urban areas, according to a cross-sectional study that was conducted in Spain.
Cristina Llaneza Suárez, a specialist in family and community medicine and the lead author of the study, told this news organization that women living in rural areas face greater difficulties with access to healthcare services, employment, and transportation and a heavier burden of caregiving. She mentioned that these barriers “can represent an added challenge during the perimenopausal stage, when significant life changes generally occur for all women.” The challenges may lead to “poorer health-related quality of life during perimenopause, compared with women living in urban areas.”
The research group led by Dr. Llaneza aimed to test the hypothesis that sociodemographic characteristics influence symptoms and quality of life in women in perimenopause. They enrolled 270 women aged 45-55 years from eight autonomous communities in Spain who had variability in their menstrual cycles (lasting more than 7 days or amenorrhea greater than 60 days but less than a year).
This cross-sectional study was conducted from December 2019 to April 2023, using the short version of the Cervantes scale to assess health-related quality of life and the Beck Depression Inventory to evaluate associated depressive symptoms.
Among the main findings of the study was that sociocultural factors can influence the perception of perimenopausal symptoms. Living in rural areas has a negative effect on health-related quality of life scales, and this finding is consistent with those of previous studies conducted on women in India, Turkey, Poland, and Peru.
In addition, the selected sample of women experiencing changes in their menstrual cycles and residing in rural areas showed a high prevalence of hot flashes (70% overall and 80% in rural areas) and a poorer quality of life in women with obesity.
“It is striking that, although there is a worse perception of quality of life during perimenopause in women living in rural areas, the proportion of women experiencing some degree of depressive symptoms, according to the Beck inventory, was similar to that of women residing in urban areas,” said Dr. Llaneza. She noted that “no worse scores were observed in sexuality or in the couple relationship.”
Rural Physicians’ Role
Women in the perimenopausal period face significant challenges resulting from inadequate access to healthcare services and limited awareness about menopause. In many countries, this topic is still taboo, both in the family environment and in workplaces and health centers.
Dr. Llaneza mentioned that when she began her training as a primary care physician in a rural population, she witnessed firsthand some of the barriers that women in this age group face, such as limited access to healthcare due to a lack of public transportation. She added that, coupled with this challenge, “there are no regular public transport services that allow independent access for patients, and many [women] lack a driver’s license, making them dependent on others to receive healthcare.” Another important point that she identified was the lack of health education in rural populations, which leads to a minimization of perimenopausal symptoms and causes delays in prevention and early detection.
According to the World Health Organization, healthcare professionals often lack the necessary training to recognize and treat the symptoms of perimenopause and postmenopause. This situation, coupled with the limited attention given to the sexual well-being of menopausal women, contributes to gynecological problems and risks for sexually transmitted infections in this population. The absence of specific health policies and funding for menopause exacerbates the situation, particularly in regions where other health needs compete for limited resources.
Dr. Llaneza noted that primary care physicians in rural areas are responsible for leading primary prevention actions through community interventions that contribute to improving health. Community physicians in rural areas have a lower patient load than urban physicians do. Therefore, “this allows for a more thorough management and closer monitoring of these conditions, which highlights the importance of prevention of perimenopausal symptoms and community education,” she said.
An important goal in improving the quality of life of women in the perimenopausal period is reducing symptoms. Hormone replacement therapy is the cornerstone of treatment, along with nonhormonal therapies such as the use of isoflavones. However, the aforementioned barriers lead to a delay in initiating effective treatment.
Dr. Llaneza added that the main limitation that she encountered during her clinical practice in rural areas regarding the initiation of hormonal therapy was “the reluctance of certain professionals to start it, as they consider that these drugs should be prescribed by menopause specialists because of potential side effects and the increased risk for developing breast cancer.”
Call for Training
Dr. Llaneza and her research team emphasized the need for further research on new drugs for controlling vasomotor symptoms, expressing their interest in conducting additional studies. “We would like to conduct a study on the use of these therapies in perimenopausal and postmenopausal women residing in rural areas.
“We believe that our data may be of interest to healthcare authorities seeking to combat population exodus in rural areas,” they wrote. In addition, they recommended additional training for rural primary care physicians on perimenopause and menopause topics regarding prevention, management, and access, as well as further awareness about preventing depressive symptoms in this population.
Dr. Llaneza declared that she has no relevant financial relationships.
This story was translated from the Medscape Spanish edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
Women in the perimenopausal period who live in rural areas have a higher prevalence of symptoms typical of this period and a poorer health-related quality of life than women living in urban areas, according to a cross-sectional study that was conducted in Spain.
Cristina Llaneza Suárez, a specialist in family and community medicine and the lead author of the study, told this news organization that women living in rural areas face greater difficulties with access to healthcare services, employment, and transportation and a heavier burden of caregiving. She mentioned that these barriers “can represent an added challenge during the perimenopausal stage, when significant life changes generally occur for all women.” The challenges may lead to “poorer health-related quality of life during perimenopause, compared with women living in urban areas.”
The research group led by Dr. Llaneza aimed to test the hypothesis that sociodemographic characteristics influence symptoms and quality of life in women in perimenopause. They enrolled 270 women aged 45-55 years from eight autonomous communities in Spain who had variability in their menstrual cycles (lasting more than 7 days or amenorrhea greater than 60 days but less than a year).
This cross-sectional study was conducted from December 2019 to April 2023, using the short version of the Cervantes scale to assess health-related quality of life and the Beck Depression Inventory to evaluate associated depressive symptoms.
Among the main findings of the study was that sociocultural factors can influence the perception of perimenopausal symptoms. Living in rural areas has a negative effect on health-related quality of life scales, and this finding is consistent with those of previous studies conducted on women in India, Turkey, Poland, and Peru.
In addition, the selected sample of women experiencing changes in their menstrual cycles and residing in rural areas showed a high prevalence of hot flashes (70% overall and 80% in rural areas) and a poorer quality of life in women with obesity.
“It is striking that, although there is a worse perception of quality of life during perimenopause in women living in rural areas, the proportion of women experiencing some degree of depressive symptoms, according to the Beck inventory, was similar to that of women residing in urban areas,” said Dr. Llaneza. She noted that “no worse scores were observed in sexuality or in the couple relationship.”
Rural Physicians’ Role
Women in the perimenopausal period face significant challenges resulting from inadequate access to healthcare services and limited awareness about menopause. In many countries, this topic is still taboo, both in the family environment and in workplaces and health centers.
Dr. Llaneza mentioned that when she began her training as a primary care physician in a rural population, she witnessed firsthand some of the barriers that women in this age group face, such as limited access to healthcare due to a lack of public transportation. She added that, coupled with this challenge, “there are no regular public transport services that allow independent access for patients, and many [women] lack a driver’s license, making them dependent on others to receive healthcare.” Another important point that she identified was the lack of health education in rural populations, which leads to a minimization of perimenopausal symptoms and causes delays in prevention and early detection.
According to the World Health Organization, healthcare professionals often lack the necessary training to recognize and treat the symptoms of perimenopause and postmenopause. This situation, coupled with the limited attention given to the sexual well-being of menopausal women, contributes to gynecological problems and risks for sexually transmitted infections in this population. The absence of specific health policies and funding for menopause exacerbates the situation, particularly in regions where other health needs compete for limited resources.
Dr. Llaneza noted that primary care physicians in rural areas are responsible for leading primary prevention actions through community interventions that contribute to improving health. Community physicians in rural areas have a lower patient load than urban physicians do. Therefore, “this allows for a more thorough management and closer monitoring of these conditions, which highlights the importance of prevention of perimenopausal symptoms and community education,” she said.
An important goal in improving the quality of life of women in the perimenopausal period is reducing symptoms. Hormone replacement therapy is the cornerstone of treatment, along with nonhormonal therapies such as the use of isoflavones. However, the aforementioned barriers lead to a delay in initiating effective treatment.
Dr. Llaneza added that the main limitation that she encountered during her clinical practice in rural areas regarding the initiation of hormonal therapy was “the reluctance of certain professionals to start it, as they consider that these drugs should be prescribed by menopause specialists because of potential side effects and the increased risk for developing breast cancer.”
Call for Training
Dr. Llaneza and her research team emphasized the need for further research on new drugs for controlling vasomotor symptoms, expressing their interest in conducting additional studies. “We would like to conduct a study on the use of these therapies in perimenopausal and postmenopausal women residing in rural areas.
“We believe that our data may be of interest to healthcare authorities seeking to combat population exodus in rural areas,” they wrote. In addition, they recommended additional training for rural primary care physicians on perimenopause and menopause topics regarding prevention, management, and access, as well as further awareness about preventing depressive symptoms in this population.
Dr. Llaneza declared that she has no relevant financial relationships.
This story was translated from the Medscape Spanish edition using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
Doctors Are Seeking Professional Coaches More Often. Here’s Why
When Andrea Austin, MD, an emergency medicine specialist, left the military in 2020, she knew the adjustment to civilian life and practice might be difficult. To help smooth the transition, she reached out to a physician mentor who also had a professional coaching certificate. After a conversation, Dr. Austin signed up for 6 months of career coaching.
It was time well spent, according to Dr. Austin, who today is a coach herself. “It was really the first time I had the ability to choose what I wanted to do, and that required a mindset shift,” she explains. “A big part of coaching is helping physicians discover their agency so that they can make the best career choices.”
Physicians have long lacked the coaching resources typically made available to corporate executives. But that’s changing. In today’s high-pressure environment, where doctors are burning out at a rapid pace, coaching can sometimes be an avenue to staying in the field, especially if that coach is a fellow physician who understands what you’re facing.
With a physician shortage that the Association of American Medical Colleges expects to hit 86,000 in the next decade or so, coaching could be a stone worth turning over. A 2024 report in JAMA Network Open found that coaching provided by physician peers led to a significant reduction in interpersonal disengagement and burnout.
“What I think is exciting about coaching is that it allows you to better understand yourself and know your strengths and weaknesses,” said Dr. Austin. “It might seem simple, but many ‘soft skills’ aren’t considered mainstream in medicine. Coaching allows us to understand them and ourselves better.”
Why Are Doctors Using Coaches?
Although it’s hard to put a number on how many physicians are turning to coaches, the number of coaches available for doctors is growing rapidly. The American Medical Women’s Association maintains a database of physician coaches. According to deputy director Jodi Godfrey, MS, RDN, the number of members who have added coaching to their skill set has tripled in the past 4 years. “Many cite burnout as the reason they sought coaching support, and then they decided to go on to get certified in coaching.”
The pandemic is one reason physician coaching has grown, said Elizabeth Esparaz, MD, an ophthalmologist and physician coach. “Since the pandemic, the word ‘burnout’ is thrown around a good deal.” And the causes are clear. “Doctors are facing longer hours, they must make split-second decisions, they’re multitasking, and they have less support staff.”
Among her coaching clients, Dr. Austin has noticed other common struggles: fears of litigation, time scarcity with patients, declining reimbursement that hasn’t kept up with inflation, and loss of autonomy because of the corporatization of healthcare.
Coaching, Dr. Esparaz believes, can be an antidote to many of these issues. “Coaches help doctors see their strengths and find better ways of applying them,” she said. “We help them move forward, and also see their blind spots.”
Clarity, Goals, and Making the Right Choices
Physician coaching comes in a variety of flavors — some one on one, and others in the form of group sessions. All, however, serve the purpose of helping physicians gain career clarity. “Sometimes clients realize their job may not be working for them, but that there are things they can do to change that without having to leave the field,” said Jattu Senesie, MD, a former ob.gyn. who is now a physician coach.
Dr. Esparaz works with doctors to establish SMART goals: specific, measurable, attainable, realistic, and time based. She gave the example of learning how to set boundaries. “If a physician is asked to create a presentation for work, I encourage them to ask for compensation or administrative time before committing to unpaid tasks.”
Another big issue: charting. It’s increasingly burdensome, and many doctors find it encroaching on their home lives. “If we can identify a problem like that, we can come up with a strategy for mitigating it,” Dr. Esparaz said. This might include setting a goal of getting 80% of charting completed immediately after the patient encounter on the busiest clinic day of the week. The client tests the experiment and then revisits it with the coach to discuss what worked and what didn’t, refining the process until it has freed up the physician’s home life.
The younger generation of doctors often struggles with career choices, too, because it’s the first time they are without structure, said Dr. Senesie. There’s med school and residency, which puts a framework around every move a doctor makes. But once they become attending physicians, the choices are endless. “Coaching can help them find a new structure and systems that will allow them to thrive.”
Although mentoring has been a well-embraced concept for decades, it “hits a wall,” at some point in terms of what it can offer, Dr. Austin said. That’s where coaching can take over. “There’s a point where a mentor cannot help someone self-actualize. As a coach, you don’t need to know everything about a doctor’s life, but you can help them learn to ask themselves the right questions to solve problems.”
Should You Stay or Should You Go?
Dr. Austin’s approach begins with the premise that healthcare today is challenging and dysfunctional — but doctors still have agency. She has worked with clients on the verge of leaving the field and helped them find their way back.
“They have a light bulb moment and open up to the idea that they have much to give still,” she said. “We take an inventory to help them better communicate their needs and make changes, and I help them connect to their values. Sometimes that exercise allows them to reframe their current work environment.”
Not every doctor who goes through coaching remains in the field. But “that’s the exception, not the rule,” Dr. Austin said. And that’s okay. “If that’s the outcome, coaching probably helped them get to that point faster, and with an informed decision.”
Dr. Senesie has been coaching for about a decade, and in that time, she’s seen a shift that goes beyond figuring out career goals. “Doctors are more aware of the need for well-being today. The pandemic made it impossible to ignore what doesn’t work for us. When I work with clients, we look for ways to make the job more tenable.”
According to Dr. Senesie, younger doctors are looking for that balance at the outset. “They want to be physicians, but they also want a life,” she said. “It’s a challenge for them because in addition to that mindset, they’re also coming out with more debt than older generations. They want out from underneath that.”
When It’s Time to Find a Physician Coach
Wondering whether coaching is right for you? Consider these symptoms:
- You need help setting boundaries at work.
- You feel like you’re sacrificing your own well-being for your job.
- You’re using maladaptive strategies to cope with the stress at work.
- You’ve reached a point where you are considering leaving the field.
If you’re interested in finding a physician coach, there are several places to begin your search, word of mouth being one of them. “Conferences and social media can also expose you to coaches,” suggested Dr. Esparaz. There are different methods and approaches to coaching. So, as you research, “make sure the coach you choose has techniques and a framework that fit what you’re after.”
Dr. Austin warned that it is an unregulated industry, so buyer beware. To ensure you’re getting an accredited physician coach, look for people who have obtained an International Coach Federation (ICF) accreditation. These coaches will hold an associate certified coach credential, which requires at least 60 hours of coaching-specific training approved by the ICF, in addition to other assessments and education.
Ensure that the coach you choose is within your budget. “There are some people charging astronomical rates out there,” Dr. Austin said. “If you’re burned out or struggling, it can be easy to reach for your credit card.”
Dr. Austin also cautioned doctors seeking a coach to avoid promises that sound too good to be true. Some coaching can have a gaslighting quality to it, she warned, “suggesting it can allow you to endure any environment.” But positive self-talk alone won’t cure an abusive or discriminatory situation. “If a client describes a toxic work environment,” the coach has an “ethical imperative” to help that person protect themselves.
A Side Gig or a New Career Path
After Dr. Austin’s experience with her coach, she made the choice to continue as an emergency physician part-time while starting her own coaching business. “It’s important for me personally to keep in touch with what’s happening on the ground, but I have no judgment for anyone who chooses to leave clinical practice to become a coach.”
When Dr. Senesie looks back on her own struggles as a clinician, she recognizes the state of burnout she was in 10 years ago. “I knew there was an issue, but I didn’t have the mindset to find a way to make it work,” she said. “I left the field when I was at my depths of burnout, which is generally not the best way to go about it.”
Guidance might have allowed her to take into account other avenues and helped her remain in the field, said Dr. Senesie. She has since learned that “there are many ways to practice medicine, and the way we’ve gone about it traditionally has worked for some, but not necessarily for everyone.”
There may be more possibilities than you think. By helping you assess your path and make meaningful changes, a physician coach might be the key to remaining in the field you love.
A version of this article first appeared on Medscape.com.
When Andrea Austin, MD, an emergency medicine specialist, left the military in 2020, she knew the adjustment to civilian life and practice might be difficult. To help smooth the transition, she reached out to a physician mentor who also had a professional coaching certificate. After a conversation, Dr. Austin signed up for 6 months of career coaching.
It was time well spent, according to Dr. Austin, who today is a coach herself. “It was really the first time I had the ability to choose what I wanted to do, and that required a mindset shift,” she explains. “A big part of coaching is helping physicians discover their agency so that they can make the best career choices.”
Physicians have long lacked the coaching resources typically made available to corporate executives. But that’s changing. In today’s high-pressure environment, where doctors are burning out at a rapid pace, coaching can sometimes be an avenue to staying in the field, especially if that coach is a fellow physician who understands what you’re facing.
With a physician shortage that the Association of American Medical Colleges expects to hit 86,000 in the next decade or so, coaching could be a stone worth turning over. A 2024 report in JAMA Network Open found that coaching provided by physician peers led to a significant reduction in interpersonal disengagement and burnout.
“What I think is exciting about coaching is that it allows you to better understand yourself and know your strengths and weaknesses,” said Dr. Austin. “It might seem simple, but many ‘soft skills’ aren’t considered mainstream in medicine. Coaching allows us to understand them and ourselves better.”
Why Are Doctors Using Coaches?
Although it’s hard to put a number on how many physicians are turning to coaches, the number of coaches available for doctors is growing rapidly. The American Medical Women’s Association maintains a database of physician coaches. According to deputy director Jodi Godfrey, MS, RDN, the number of members who have added coaching to their skill set has tripled in the past 4 years. “Many cite burnout as the reason they sought coaching support, and then they decided to go on to get certified in coaching.”
The pandemic is one reason physician coaching has grown, said Elizabeth Esparaz, MD, an ophthalmologist and physician coach. “Since the pandemic, the word ‘burnout’ is thrown around a good deal.” And the causes are clear. “Doctors are facing longer hours, they must make split-second decisions, they’re multitasking, and they have less support staff.”
Among her coaching clients, Dr. Austin has noticed other common struggles: fears of litigation, time scarcity with patients, declining reimbursement that hasn’t kept up with inflation, and loss of autonomy because of the corporatization of healthcare.
Coaching, Dr. Esparaz believes, can be an antidote to many of these issues. “Coaches help doctors see their strengths and find better ways of applying them,” she said. “We help them move forward, and also see their blind spots.”
Clarity, Goals, and Making the Right Choices
Physician coaching comes in a variety of flavors — some one on one, and others in the form of group sessions. All, however, serve the purpose of helping physicians gain career clarity. “Sometimes clients realize their job may not be working for them, but that there are things they can do to change that without having to leave the field,” said Jattu Senesie, MD, a former ob.gyn. who is now a physician coach.
Dr. Esparaz works with doctors to establish SMART goals: specific, measurable, attainable, realistic, and time based. She gave the example of learning how to set boundaries. “If a physician is asked to create a presentation for work, I encourage them to ask for compensation or administrative time before committing to unpaid tasks.”
Another big issue: charting. It’s increasingly burdensome, and many doctors find it encroaching on their home lives. “If we can identify a problem like that, we can come up with a strategy for mitigating it,” Dr. Esparaz said. This might include setting a goal of getting 80% of charting completed immediately after the patient encounter on the busiest clinic day of the week. The client tests the experiment and then revisits it with the coach to discuss what worked and what didn’t, refining the process until it has freed up the physician’s home life.
The younger generation of doctors often struggles with career choices, too, because it’s the first time they are without structure, said Dr. Senesie. There’s med school and residency, which puts a framework around every move a doctor makes. But once they become attending physicians, the choices are endless. “Coaching can help them find a new structure and systems that will allow them to thrive.”
Although mentoring has been a well-embraced concept for decades, it “hits a wall,” at some point in terms of what it can offer, Dr. Austin said. That’s where coaching can take over. “There’s a point where a mentor cannot help someone self-actualize. As a coach, you don’t need to know everything about a doctor’s life, but you can help them learn to ask themselves the right questions to solve problems.”
Should You Stay or Should You Go?
Dr. Austin’s approach begins with the premise that healthcare today is challenging and dysfunctional — but doctors still have agency. She has worked with clients on the verge of leaving the field and helped them find their way back.
“They have a light bulb moment and open up to the idea that they have much to give still,” she said. “We take an inventory to help them better communicate their needs and make changes, and I help them connect to their values. Sometimes that exercise allows them to reframe their current work environment.”
Not every doctor who goes through coaching remains in the field. But “that’s the exception, not the rule,” Dr. Austin said. And that’s okay. “If that’s the outcome, coaching probably helped them get to that point faster, and with an informed decision.”
Dr. Senesie has been coaching for about a decade, and in that time, she’s seen a shift that goes beyond figuring out career goals. “Doctors are more aware of the need for well-being today. The pandemic made it impossible to ignore what doesn’t work for us. When I work with clients, we look for ways to make the job more tenable.”
According to Dr. Senesie, younger doctors are looking for that balance at the outset. “They want to be physicians, but they also want a life,” she said. “It’s a challenge for them because in addition to that mindset, they’re also coming out with more debt than older generations. They want out from underneath that.”
When It’s Time to Find a Physician Coach
Wondering whether coaching is right for you? Consider these symptoms:
- You need help setting boundaries at work.
- You feel like you’re sacrificing your own well-being for your job.
- You’re using maladaptive strategies to cope with the stress at work.
- You’ve reached a point where you are considering leaving the field.
If you’re interested in finding a physician coach, there are several places to begin your search, word of mouth being one of them. “Conferences and social media can also expose you to coaches,” suggested Dr. Esparaz. There are different methods and approaches to coaching. So, as you research, “make sure the coach you choose has techniques and a framework that fit what you’re after.”
Dr. Austin warned that it is an unregulated industry, so buyer beware. To ensure you’re getting an accredited physician coach, look for people who have obtained an International Coach Federation (ICF) accreditation. These coaches will hold an associate certified coach credential, which requires at least 60 hours of coaching-specific training approved by the ICF, in addition to other assessments and education.
Ensure that the coach you choose is within your budget. “There are some people charging astronomical rates out there,” Dr. Austin said. “If you’re burned out or struggling, it can be easy to reach for your credit card.”
Dr. Austin also cautioned doctors seeking a coach to avoid promises that sound too good to be true. Some coaching can have a gaslighting quality to it, she warned, “suggesting it can allow you to endure any environment.” But positive self-talk alone won’t cure an abusive or discriminatory situation. “If a client describes a toxic work environment,” the coach has an “ethical imperative” to help that person protect themselves.
A Side Gig or a New Career Path
After Dr. Austin’s experience with her coach, she made the choice to continue as an emergency physician part-time while starting her own coaching business. “It’s important for me personally to keep in touch with what’s happening on the ground, but I have no judgment for anyone who chooses to leave clinical practice to become a coach.”
When Dr. Senesie looks back on her own struggles as a clinician, she recognizes the state of burnout she was in 10 years ago. “I knew there was an issue, but I didn’t have the mindset to find a way to make it work,” she said. “I left the field when I was at my depths of burnout, which is generally not the best way to go about it.”
Guidance might have allowed her to take into account other avenues and helped her remain in the field, said Dr. Senesie. She has since learned that “there are many ways to practice medicine, and the way we’ve gone about it traditionally has worked for some, but not necessarily for everyone.”
There may be more possibilities than you think. By helping you assess your path and make meaningful changes, a physician coach might be the key to remaining in the field you love.
A version of this article first appeared on Medscape.com.
When Andrea Austin, MD, an emergency medicine specialist, left the military in 2020, she knew the adjustment to civilian life and practice might be difficult. To help smooth the transition, she reached out to a physician mentor who also had a professional coaching certificate. After a conversation, Dr. Austin signed up for 6 months of career coaching.
It was time well spent, according to Dr. Austin, who today is a coach herself. “It was really the first time I had the ability to choose what I wanted to do, and that required a mindset shift,” she explains. “A big part of coaching is helping physicians discover their agency so that they can make the best career choices.”
Physicians have long lacked the coaching resources typically made available to corporate executives. But that’s changing. In today’s high-pressure environment, where doctors are burning out at a rapid pace, coaching can sometimes be an avenue to staying in the field, especially if that coach is a fellow physician who understands what you’re facing.
With a physician shortage that the Association of American Medical Colleges expects to hit 86,000 in the next decade or so, coaching could be a stone worth turning over. A 2024 report in JAMA Network Open found that coaching provided by physician peers led to a significant reduction in interpersonal disengagement and burnout.
“What I think is exciting about coaching is that it allows you to better understand yourself and know your strengths and weaknesses,” said Dr. Austin. “It might seem simple, but many ‘soft skills’ aren’t considered mainstream in medicine. Coaching allows us to understand them and ourselves better.”
Why Are Doctors Using Coaches?
Although it’s hard to put a number on how many physicians are turning to coaches, the number of coaches available for doctors is growing rapidly. The American Medical Women’s Association maintains a database of physician coaches. According to deputy director Jodi Godfrey, MS, RDN, the number of members who have added coaching to their skill set has tripled in the past 4 years. “Many cite burnout as the reason they sought coaching support, and then they decided to go on to get certified in coaching.”
The pandemic is one reason physician coaching has grown, said Elizabeth Esparaz, MD, an ophthalmologist and physician coach. “Since the pandemic, the word ‘burnout’ is thrown around a good deal.” And the causes are clear. “Doctors are facing longer hours, they must make split-second decisions, they’re multitasking, and they have less support staff.”
Among her coaching clients, Dr. Austin has noticed other common struggles: fears of litigation, time scarcity with patients, declining reimbursement that hasn’t kept up with inflation, and loss of autonomy because of the corporatization of healthcare.
Coaching, Dr. Esparaz believes, can be an antidote to many of these issues. “Coaches help doctors see their strengths and find better ways of applying them,” she said. “We help them move forward, and also see their blind spots.”
Clarity, Goals, and Making the Right Choices
Physician coaching comes in a variety of flavors — some one on one, and others in the form of group sessions. All, however, serve the purpose of helping physicians gain career clarity. “Sometimes clients realize their job may not be working for them, but that there are things they can do to change that without having to leave the field,” said Jattu Senesie, MD, a former ob.gyn. who is now a physician coach.
Dr. Esparaz works with doctors to establish SMART goals: specific, measurable, attainable, realistic, and time based. She gave the example of learning how to set boundaries. “If a physician is asked to create a presentation for work, I encourage them to ask for compensation or administrative time before committing to unpaid tasks.”
Another big issue: charting. It’s increasingly burdensome, and many doctors find it encroaching on their home lives. “If we can identify a problem like that, we can come up with a strategy for mitigating it,” Dr. Esparaz said. This might include setting a goal of getting 80% of charting completed immediately after the patient encounter on the busiest clinic day of the week. The client tests the experiment and then revisits it with the coach to discuss what worked and what didn’t, refining the process until it has freed up the physician’s home life.
The younger generation of doctors often struggles with career choices, too, because it’s the first time they are without structure, said Dr. Senesie. There’s med school and residency, which puts a framework around every move a doctor makes. But once they become attending physicians, the choices are endless. “Coaching can help them find a new structure and systems that will allow them to thrive.”
Although mentoring has been a well-embraced concept for decades, it “hits a wall,” at some point in terms of what it can offer, Dr. Austin said. That’s where coaching can take over. “There’s a point where a mentor cannot help someone self-actualize. As a coach, you don’t need to know everything about a doctor’s life, but you can help them learn to ask themselves the right questions to solve problems.”
Should You Stay or Should You Go?
Dr. Austin’s approach begins with the premise that healthcare today is challenging and dysfunctional — but doctors still have agency. She has worked with clients on the verge of leaving the field and helped them find their way back.
“They have a light bulb moment and open up to the idea that they have much to give still,” she said. “We take an inventory to help them better communicate their needs and make changes, and I help them connect to their values. Sometimes that exercise allows them to reframe their current work environment.”
Not every doctor who goes through coaching remains in the field. But “that’s the exception, not the rule,” Dr. Austin said. And that’s okay. “If that’s the outcome, coaching probably helped them get to that point faster, and with an informed decision.”
Dr. Senesie has been coaching for about a decade, and in that time, she’s seen a shift that goes beyond figuring out career goals. “Doctors are more aware of the need for well-being today. The pandemic made it impossible to ignore what doesn’t work for us. When I work with clients, we look for ways to make the job more tenable.”
According to Dr. Senesie, younger doctors are looking for that balance at the outset. “They want to be physicians, but they also want a life,” she said. “It’s a challenge for them because in addition to that mindset, they’re also coming out with more debt than older generations. They want out from underneath that.”
When It’s Time to Find a Physician Coach
Wondering whether coaching is right for you? Consider these symptoms:
- You need help setting boundaries at work.
- You feel like you’re sacrificing your own well-being for your job.
- You’re using maladaptive strategies to cope with the stress at work.
- You’ve reached a point where you are considering leaving the field.
If you’re interested in finding a physician coach, there are several places to begin your search, word of mouth being one of them. “Conferences and social media can also expose you to coaches,” suggested Dr. Esparaz. There are different methods and approaches to coaching. So, as you research, “make sure the coach you choose has techniques and a framework that fit what you’re after.”
Dr. Austin warned that it is an unregulated industry, so buyer beware. To ensure you’re getting an accredited physician coach, look for people who have obtained an International Coach Federation (ICF) accreditation. These coaches will hold an associate certified coach credential, which requires at least 60 hours of coaching-specific training approved by the ICF, in addition to other assessments and education.
Ensure that the coach you choose is within your budget. “There are some people charging astronomical rates out there,” Dr. Austin said. “If you’re burned out or struggling, it can be easy to reach for your credit card.”
Dr. Austin also cautioned doctors seeking a coach to avoid promises that sound too good to be true. Some coaching can have a gaslighting quality to it, she warned, “suggesting it can allow you to endure any environment.” But positive self-talk alone won’t cure an abusive or discriminatory situation. “If a client describes a toxic work environment,” the coach has an “ethical imperative” to help that person protect themselves.
A Side Gig or a New Career Path
After Dr. Austin’s experience with her coach, she made the choice to continue as an emergency physician part-time while starting her own coaching business. “It’s important for me personally to keep in touch with what’s happening on the ground, but I have no judgment for anyone who chooses to leave clinical practice to become a coach.”
When Dr. Senesie looks back on her own struggles as a clinician, she recognizes the state of burnout she was in 10 years ago. “I knew there was an issue, but I didn’t have the mindset to find a way to make it work,” she said. “I left the field when I was at my depths of burnout, which is generally not the best way to go about it.”
Guidance might have allowed her to take into account other avenues and helped her remain in the field, said Dr. Senesie. She has since learned that “there are many ways to practice medicine, and the way we’ve gone about it traditionally has worked for some, but not necessarily for everyone.”
There may be more possibilities than you think. By helping you assess your path and make meaningful changes, a physician coach might be the key to remaining in the field you love.
A version of this article first appeared on Medscape.com.
Breast Cancer Index Predicts Benefit of Ovarian Function Suppression in Premenopausal Women
TOPLINE:
Women with BCI HOXB13/IL17BR ratio (BCI[H/I])–low tumors showed significant benefit from OFS, whereas those with BCI(H/I)-high tumors did not.
METHODOLOGY:
- Researchers conducted a prospective-retrospective translational study using tumor tissue samples from 1,718 premenopausal women with hormone receptor–positive early-stage breast cancer.
- Participants were randomly assigned to receive 5 years of tamoxifen alone, tamoxifen plus OFS, or exemestane plus OFS.
- BCI testing was performed on RNA extracted from formalin-fixed paraffin-embedded tumor specimens, blinded to clinical data and outcomes.
- The primary endpoints were breast cancer–free interval (BCFI) and distant recurrence-free interval (DRFI), with a median follow-up time of 12 years.
- Settings spanned multiple centers internationally, and data were collected from December 2003 to April 2021, analyzed from May 2022 to October 2022.
TAKEAWAY:
- According to the authors, patients with BCI(H/I)-low tumors exhibited a 12-year absolute benefit in BCFI of 11.6% from exemestane plus OFS (hazard ratio [HR], 0.48; 95% CI, 0.33-0.71) and 7.3% from tamoxifen plus OFS (HR, 0.69; 95% CI, 0.48-0.97), relative to tamoxifen alone.
- Patients with BCI(H/I)-high tumors did not derive significant benefit from either exemestane plus OFS (absolute benefit, -0.4%; HR, 1.03; 95% CI, 0.70-1.53) or tamoxifen plus OFS (absolute benefit, -1.2%; HR, 1.05; 95% CI, 0.72-1.54), compared with tamoxifen alone.
- In the ERBB2-negative subgroup, patients with BCI(H/I)-low tumors experienced a 12-year absolute benefit of 13.2% in BCFI from exemestane plus OFS (HR, 0.39; 95% CI, 0.25-0.60) and 7.4% from tamoxifen plus OFS (HR, 0.64; 95% CI, 0.44-0.93), compared with tamoxifen alone.
- BCI continuous index was significantly prognostic in the subgroup for DRFI (n = 1110; P =.004), with 12-year DRFI of 95.9%, 90.8%, and 86.3% in BCI low-risk, intermediate-risk, and high-risk cases of cancer than had not spread to nearly lymph nodes (N0 cancers), respectively.
IN PRACTICE:
“This investigation suggests a potential clinical use of BCI(H/I) results, adding to their use to identify patients most likely to benefit from extended endocrine therapy, as proven in multiple studies, although in the extended endocrine validation studies, it was the BCI(H/I)-high group that derived the greatest benefit,” wrote the authors of the study.
SOURCE:
The study was led by Ruth M. O’Regan, MD, University of Rochester Department of Medicine in Rochester, New York. It was published online on August 15, in JAMA Oncology.
LIMITATIONS:
The study’s retrospective nature may introduce biases despite the prospective statistical analysis plan. The sample size for certain clinical subgroups might be too small to definitively confirm the predictive value of BCI(H/I) for OFS benefit. The generalizability of the findings may be limited due to the specific population studied. Further validation in other patient cohorts is necessary to confirm these findings.
DISCLOSURES:
Dr. O’Regan disclosed receiving personal fees from Pfizer and Gilead DSMB, grants from Puma, and nonfinancial support from Novartis. Additional disclosures are noted in the original article.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
Women with BCI HOXB13/IL17BR ratio (BCI[H/I])–low tumors showed significant benefit from OFS, whereas those with BCI(H/I)-high tumors did not.
METHODOLOGY:
- Researchers conducted a prospective-retrospective translational study using tumor tissue samples from 1,718 premenopausal women with hormone receptor–positive early-stage breast cancer.
- Participants were randomly assigned to receive 5 years of tamoxifen alone, tamoxifen plus OFS, or exemestane plus OFS.
- BCI testing was performed on RNA extracted from formalin-fixed paraffin-embedded tumor specimens, blinded to clinical data and outcomes.
- The primary endpoints were breast cancer–free interval (BCFI) and distant recurrence-free interval (DRFI), with a median follow-up time of 12 years.
- Settings spanned multiple centers internationally, and data were collected from December 2003 to April 2021, analyzed from May 2022 to October 2022.
TAKEAWAY:
- According to the authors, patients with BCI(H/I)-low tumors exhibited a 12-year absolute benefit in BCFI of 11.6% from exemestane plus OFS (hazard ratio [HR], 0.48; 95% CI, 0.33-0.71) and 7.3% from tamoxifen plus OFS (HR, 0.69; 95% CI, 0.48-0.97), relative to tamoxifen alone.
- Patients with BCI(H/I)-high tumors did not derive significant benefit from either exemestane plus OFS (absolute benefit, -0.4%; HR, 1.03; 95% CI, 0.70-1.53) or tamoxifen plus OFS (absolute benefit, -1.2%; HR, 1.05; 95% CI, 0.72-1.54), compared with tamoxifen alone.
- In the ERBB2-negative subgroup, patients with BCI(H/I)-low tumors experienced a 12-year absolute benefit of 13.2% in BCFI from exemestane plus OFS (HR, 0.39; 95% CI, 0.25-0.60) and 7.4% from tamoxifen plus OFS (HR, 0.64; 95% CI, 0.44-0.93), compared with tamoxifen alone.
- BCI continuous index was significantly prognostic in the subgroup for DRFI (n = 1110; P =.004), with 12-year DRFI of 95.9%, 90.8%, and 86.3% in BCI low-risk, intermediate-risk, and high-risk cases of cancer than had not spread to nearly lymph nodes (N0 cancers), respectively.
IN PRACTICE:
“This investigation suggests a potential clinical use of BCI(H/I) results, adding to their use to identify patients most likely to benefit from extended endocrine therapy, as proven in multiple studies, although in the extended endocrine validation studies, it was the BCI(H/I)-high group that derived the greatest benefit,” wrote the authors of the study.
SOURCE:
The study was led by Ruth M. O’Regan, MD, University of Rochester Department of Medicine in Rochester, New York. It was published online on August 15, in JAMA Oncology.
LIMITATIONS:
The study’s retrospective nature may introduce biases despite the prospective statistical analysis plan. The sample size for certain clinical subgroups might be too small to definitively confirm the predictive value of BCI(H/I) for OFS benefit. The generalizability of the findings may be limited due to the specific population studied. Further validation in other patient cohorts is necessary to confirm these findings.
DISCLOSURES:
Dr. O’Regan disclosed receiving personal fees from Pfizer and Gilead DSMB, grants from Puma, and nonfinancial support from Novartis. Additional disclosures are noted in the original article.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
Women with BCI HOXB13/IL17BR ratio (BCI[H/I])–low tumors showed significant benefit from OFS, whereas those with BCI(H/I)-high tumors did not.
METHODOLOGY:
- Researchers conducted a prospective-retrospective translational study using tumor tissue samples from 1,718 premenopausal women with hormone receptor–positive early-stage breast cancer.
- Participants were randomly assigned to receive 5 years of tamoxifen alone, tamoxifen plus OFS, or exemestane plus OFS.
- BCI testing was performed on RNA extracted from formalin-fixed paraffin-embedded tumor specimens, blinded to clinical data and outcomes.
- The primary endpoints were breast cancer–free interval (BCFI) and distant recurrence-free interval (DRFI), with a median follow-up time of 12 years.
- Settings spanned multiple centers internationally, and data were collected from December 2003 to April 2021, analyzed from May 2022 to October 2022.
TAKEAWAY:
- According to the authors, patients with BCI(H/I)-low tumors exhibited a 12-year absolute benefit in BCFI of 11.6% from exemestane plus OFS (hazard ratio [HR], 0.48; 95% CI, 0.33-0.71) and 7.3% from tamoxifen plus OFS (HR, 0.69; 95% CI, 0.48-0.97), relative to tamoxifen alone.
- Patients with BCI(H/I)-high tumors did not derive significant benefit from either exemestane plus OFS (absolute benefit, -0.4%; HR, 1.03; 95% CI, 0.70-1.53) or tamoxifen plus OFS (absolute benefit, -1.2%; HR, 1.05; 95% CI, 0.72-1.54), compared with tamoxifen alone.
- In the ERBB2-negative subgroup, patients with BCI(H/I)-low tumors experienced a 12-year absolute benefit of 13.2% in BCFI from exemestane plus OFS (HR, 0.39; 95% CI, 0.25-0.60) and 7.4% from tamoxifen plus OFS (HR, 0.64; 95% CI, 0.44-0.93), compared with tamoxifen alone.
- BCI continuous index was significantly prognostic in the subgroup for DRFI (n = 1110; P =.004), with 12-year DRFI of 95.9%, 90.8%, and 86.3% in BCI low-risk, intermediate-risk, and high-risk cases of cancer than had not spread to nearly lymph nodes (N0 cancers), respectively.
IN PRACTICE:
“This investigation suggests a potential clinical use of BCI(H/I) results, adding to their use to identify patients most likely to benefit from extended endocrine therapy, as proven in multiple studies, although in the extended endocrine validation studies, it was the BCI(H/I)-high group that derived the greatest benefit,” wrote the authors of the study.
SOURCE:
The study was led by Ruth M. O’Regan, MD, University of Rochester Department of Medicine in Rochester, New York. It was published online on August 15, in JAMA Oncology.
LIMITATIONS:
The study’s retrospective nature may introduce biases despite the prospective statistical analysis plan. The sample size for certain clinical subgroups might be too small to definitively confirm the predictive value of BCI(H/I) for OFS benefit. The generalizability of the findings may be limited due to the specific population studied. Further validation in other patient cohorts is necessary to confirm these findings.
DISCLOSURES:
Dr. O’Regan disclosed receiving personal fees from Pfizer and Gilead DSMB, grants from Puma, and nonfinancial support from Novartis. Additional disclosures are noted in the original article.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
Radiation Therapy Underused After Nipple-Sparing Mastectomy
TOPLINE:
METHODOLOGY:
- Nipple-sparing mastectomy has become increasingly popular for treating early-stage breast cancer given the cosmetic and functional benefits of the procedure. However, appropriate use of adjuvant radiation therapy following nipple-sparing mastectomy has not been characterized.
- Researchers compared outcomes and appropriate uses of radiation therapy among 624,075 women diagnosed with cT1-3N0M0 invasive ductal or lobular breast cancer between 2004 and 2017 who underwent breast-conserving surgery (n = 611,907; median age, 63 years) or nipple-sparing mastectomy (n = 12,168; median age, 50 years).
- The researchers compared the rates of postoperative radiation therapy for two standard indications — positive margins and pathologic node involvement — in patients who had breast-conserving surgery or nipple-sparing mastectomy.
- The team also compared overall survival outcomes in patients with positive margins and node involvement.
TAKEAWAY:
- Patients who had nipple-sparing surgery had higher rates of positive margins (4.5% vs 3.7%; P < .001) and, on multivariable analysis, a 15% higher risk for positive margins compared with those who had breast-conserving surgery (odds ratio [OR], 1.15; P = .005).
- Similarly, patients who had nipple-sparing surgery had significantly higher rates of node involvement compared with those who had breast-conserving surgery (22.5% vs 13.5%) and, on multivariable analysis, an 8% higher risk for node involvement (OR, 1.08; P < .001).
- Despite higher rates of positive margins and node involvement in the nipple-sparing surgery group, these patients were significantly less likely than those in the breast-conserving surgery group to receive adjuvant radiation therapy (OR, 0.07). Overall, only 17.2% of patients who underwent nipple-sparing mastectomy received postoperative radiation therapy compared with 83.3% of those undergoing breast-conserving surgery — an almost fivefold difference (P < .001).
- In the overall study sample, overall survival in the two surgical groups did not differ significantly among patients with positive margins (OR, 0.62; 95% CI, 0.30-1.31; P = .21) and those with node involvement (OR, 1.01; 95% CI, 0.80-1.28; P = .93).
IN PRACTICE:
The researchers emphasized that although overall survival outcomes were comparable in the two surgery groups, the “current standard indications and guidelines for post-mastectomy radiation are not being appropriately” used after nipple-sparing mastectomy.
SOURCE:
The study, led by Wesley J. Talcott, MD, MBA, Department of Radiation Medicine, Northwell Health, New York City, was published online in Advances in Radiation Oncology.
LIMITATIONS:
Data on locoregional recurrence, cause-specific mortality, and all pathologic details were not available. The relatively short median follow-up period might not capture differences in the long-term survival outcomes.
DISCLOSURES:
The study did not receive any funding support. The authors disclosed no conflicts of interest.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- Nipple-sparing mastectomy has become increasingly popular for treating early-stage breast cancer given the cosmetic and functional benefits of the procedure. However, appropriate use of adjuvant radiation therapy following nipple-sparing mastectomy has not been characterized.
- Researchers compared outcomes and appropriate uses of radiation therapy among 624,075 women diagnosed with cT1-3N0M0 invasive ductal or lobular breast cancer between 2004 and 2017 who underwent breast-conserving surgery (n = 611,907; median age, 63 years) or nipple-sparing mastectomy (n = 12,168; median age, 50 years).
- The researchers compared the rates of postoperative radiation therapy for two standard indications — positive margins and pathologic node involvement — in patients who had breast-conserving surgery or nipple-sparing mastectomy.
- The team also compared overall survival outcomes in patients with positive margins and node involvement.
TAKEAWAY:
- Patients who had nipple-sparing surgery had higher rates of positive margins (4.5% vs 3.7%; P < .001) and, on multivariable analysis, a 15% higher risk for positive margins compared with those who had breast-conserving surgery (odds ratio [OR], 1.15; P = .005).
- Similarly, patients who had nipple-sparing surgery had significantly higher rates of node involvement compared with those who had breast-conserving surgery (22.5% vs 13.5%) and, on multivariable analysis, an 8% higher risk for node involvement (OR, 1.08; P < .001).
- Despite higher rates of positive margins and node involvement in the nipple-sparing surgery group, these patients were significantly less likely than those in the breast-conserving surgery group to receive adjuvant radiation therapy (OR, 0.07). Overall, only 17.2% of patients who underwent nipple-sparing mastectomy received postoperative radiation therapy compared with 83.3% of those undergoing breast-conserving surgery — an almost fivefold difference (P < .001).
- In the overall study sample, overall survival in the two surgical groups did not differ significantly among patients with positive margins (OR, 0.62; 95% CI, 0.30-1.31; P = .21) and those with node involvement (OR, 1.01; 95% CI, 0.80-1.28; P = .93).
IN PRACTICE:
The researchers emphasized that although overall survival outcomes were comparable in the two surgery groups, the “current standard indications and guidelines for post-mastectomy radiation are not being appropriately” used after nipple-sparing mastectomy.
SOURCE:
The study, led by Wesley J. Talcott, MD, MBA, Department of Radiation Medicine, Northwell Health, New York City, was published online in Advances in Radiation Oncology.
LIMITATIONS:
Data on locoregional recurrence, cause-specific mortality, and all pathologic details were not available. The relatively short median follow-up period might not capture differences in the long-term survival outcomes.
DISCLOSURES:
The study did not receive any funding support. The authors disclosed no conflicts of interest.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- Nipple-sparing mastectomy has become increasingly popular for treating early-stage breast cancer given the cosmetic and functional benefits of the procedure. However, appropriate use of adjuvant radiation therapy following nipple-sparing mastectomy has not been characterized.
- Researchers compared outcomes and appropriate uses of radiation therapy among 624,075 women diagnosed with cT1-3N0M0 invasive ductal or lobular breast cancer between 2004 and 2017 who underwent breast-conserving surgery (n = 611,907; median age, 63 years) or nipple-sparing mastectomy (n = 12,168; median age, 50 years).
- The researchers compared the rates of postoperative radiation therapy for two standard indications — positive margins and pathologic node involvement — in patients who had breast-conserving surgery or nipple-sparing mastectomy.
- The team also compared overall survival outcomes in patients with positive margins and node involvement.
TAKEAWAY:
- Patients who had nipple-sparing surgery had higher rates of positive margins (4.5% vs 3.7%; P < .001) and, on multivariable analysis, a 15% higher risk for positive margins compared with those who had breast-conserving surgery (odds ratio [OR], 1.15; P = .005).
- Similarly, patients who had nipple-sparing surgery had significantly higher rates of node involvement compared with those who had breast-conserving surgery (22.5% vs 13.5%) and, on multivariable analysis, an 8% higher risk for node involvement (OR, 1.08; P < .001).
- Despite higher rates of positive margins and node involvement in the nipple-sparing surgery group, these patients were significantly less likely than those in the breast-conserving surgery group to receive adjuvant radiation therapy (OR, 0.07). Overall, only 17.2% of patients who underwent nipple-sparing mastectomy received postoperative radiation therapy compared with 83.3% of those undergoing breast-conserving surgery — an almost fivefold difference (P < .001).
- In the overall study sample, overall survival in the two surgical groups did not differ significantly among patients with positive margins (OR, 0.62; 95% CI, 0.30-1.31; P = .21) and those with node involvement (OR, 1.01; 95% CI, 0.80-1.28; P = .93).
IN PRACTICE:
The researchers emphasized that although overall survival outcomes were comparable in the two surgery groups, the “current standard indications and guidelines for post-mastectomy radiation are not being appropriately” used after nipple-sparing mastectomy.
SOURCE:
The study, led by Wesley J. Talcott, MD, MBA, Department of Radiation Medicine, Northwell Health, New York City, was published online in Advances in Radiation Oncology.
LIMITATIONS:
Data on locoregional recurrence, cause-specific mortality, and all pathologic details were not available. The relatively short median follow-up period might not capture differences in the long-term survival outcomes.
DISCLOSURES:
The study did not receive any funding support. The authors disclosed no conflicts of interest.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
BRCA Mutations in Men: Important but Often Overlooked
BRCA1 and BRCA2 pathogenic variants carry well-known associations with breast and ovarian cancers in women, which has led to robust clinical guidelines for early genetic testing and risk-reduction strategies.
Male carriers of BRCA1/2 pathogenic variants also face an increased risk for cancer, particularly of the prostate, pancreas, and breast.
However, men often fly under the radar.
“Most people (including their clinicians) are unaware of their carrier status,” Heather Cheng, MD, PhD, with University of Washington, Seattle, and colleagues explained in a comprehensive review on the subject, published in JAMA Oncology. Most are also unaware of “the associated cancer risks, and management recommendations” for BRCA carriers.
The testing gap in males may exist, in part, because of a “general lack of awareness” that BRCA gene mutations can be passed down to children from both the mother and father, Elisa Port, MD, chief of breast surgery for the Mount Sinai Health System in New York City, told this news organization.
A daughter can inherit a mutated BRCA gene that puts her at risk for breast or ovarian cancer from her mother’s or father’s family and, similarly, a son can inherit a mutated BRCA gene from either side of the family that puts him at an increased risk for developing prostate and other cancers, explained Dr. Port, director of the Center of Excellence for Breast Cancer at The Tisch Cancer Institute at Mount Sinai.
Considering family history and genetics on both sides of the family is important when assessing cancer risk in men and women, Dr. Port said.
BRCA Mutations in Men: What’s the Risk?
Although fewer than 1% of all breast cancers occur in men, when men do carry a BRCA mutation, their risk for breast cancer can increase considerably. The lifetime risk for breast cancer can be as high as 9% in male BRCA2 carriers and up to 1.2% in BRCA1 carriers.
BRCA1/2 mutations also put men at increased risk for pancreatic and prostate cancers.
For pancreatic cancer, male BRCA1 carriers have a nearly twofold increased risk compared with the general population, with a lifetime risk of 3%. BRCA2 carriers have a three- to nearly eightfold increased risk, with a lifetime risk up to 7%.
Male BRCA1 carriers face a nearly fourfold increased risk of developing prostate cancer and an absolute lifetime risk of 15%-45%. Male BRCA2 carriers have a five- to ninefold increased risk for prostate cancer, with an absolute lifetime risk between 27% and 60%.
When to Test, When to Screen?
Despite the increased risk for several cancers associated with BRCA mutations, many men are not offered genetic testing.
BRCA1/2 genetic testing in men is “ultra-important but underutilized and is an evolving unmet need that the field needs to address,” Kai Tsao, MD MS, medical director of the Medical Oncology Prostate Cancer Program at Mount Sinai in New York City, told this news organization.
For men considering genetic testing, in Dr. Tsao’s experience, barriers may include fear that insurance may not cover the test and that a positive test may increase insurance premiums, as well as concerns about what the test result may mean for them and their family.
Even for confirmed BRCA carriers, cancer screening guidelines for men vary.
For breast screening in men, there’s limited data to inform guidelines. The National Cancer Center Network currently recommends breast awareness and teaching self-examination starting at age 35 and recommends men with BRCA variants consider yearly mammograms starting at age 50, or 10 years before the earliest male breast cancer diagnosis in the family.
Data show that screening mammography in men at high-risk for breast cancer yields similar cancer detection rates in men and women, “suggesting mammography screening may be valuable in male BRCA carriers,” the review authors noted. And, in a recent study of men with BRCA1/2 pathogenic variants, most (71%) recommended for screening mammography completed their screening.
The European Society for Medical Oncology (ESMO) has similar screening recommendations but focuses only on men with BRCA2 mutations and suggests breast ultrasonography as well as mammography as a screening option.
The larger “issue is the general population doesn’t think of breast cancer when they think of men, which may delay seeking medical attention,” said Melissa Fana, MD, of NYU Grossman Long Island School of Medicine and NYU Langone Health, who wasn’t involved in the review.
For pancreatic cancer, guidelines suggest BRCA1/2 carriers be screened for pancreatic cancer starting at age 50, or 10 years before the earliest known pancreatic cancer in the family, although the guidelines vary on the role family history should play.
And for prostate cancer, current guidelines recommend male BRCA carriers begin prostate-specific antigen screening between age 40 and 45 years, although recommendations on screening intervals and start age vary. ESMO recommendations are similar but only apply to BRCA2 carriers.
A male patient with a BRCA1/2 variant is typically referred for genetic counseling as well, Dr. Tsao explained. But “the challenge is that we don’t have a very good healthcare infrastructure right now” to follow through with that, he added. “Oftentimes a patient will wait many months or even more than a year for a genetic counseling appointment.”
To help improve these issues, Mount Sinai recently launched a comprehensive BRCA program for men and women that offers genetic testing and counseling for patients and family members.
Overall, identifying more male BRCA1/2 carriers will “maximize opportunities for cancer early detection, targeted risk management, and cancer treatment for males, along with facilitating opportunities for risk reduction and prevention in their family members, thereby decreasing the burden of hereditary cancer,” Dr. Cheng and colleagues concluded.
Support for the review was provided in part by BRCA Research and Cure Alliance and the Men & BRCA Program at the Basser Center for BRCA. Cheng reported grants from Promontory Pharmaceutics, Medivation, Sanofi, Janssen, royalties from UpToDate, nonfinancial support from Color Health, personal fees from AstraZeneca, BRCA Research and Cure Alliance (CureBRCA) outside the submitted work. Dr. Port, Dr. Tsao, and Dr. Fana had no conflicts of interest.
A version of this article first appeared on Medscape.com.
BRCA1 and BRCA2 pathogenic variants carry well-known associations with breast and ovarian cancers in women, which has led to robust clinical guidelines for early genetic testing and risk-reduction strategies.
Male carriers of BRCA1/2 pathogenic variants also face an increased risk for cancer, particularly of the prostate, pancreas, and breast.
However, men often fly under the radar.
“Most people (including their clinicians) are unaware of their carrier status,” Heather Cheng, MD, PhD, with University of Washington, Seattle, and colleagues explained in a comprehensive review on the subject, published in JAMA Oncology. Most are also unaware of “the associated cancer risks, and management recommendations” for BRCA carriers.
The testing gap in males may exist, in part, because of a “general lack of awareness” that BRCA gene mutations can be passed down to children from both the mother and father, Elisa Port, MD, chief of breast surgery for the Mount Sinai Health System in New York City, told this news organization.
A daughter can inherit a mutated BRCA gene that puts her at risk for breast or ovarian cancer from her mother’s or father’s family and, similarly, a son can inherit a mutated BRCA gene from either side of the family that puts him at an increased risk for developing prostate and other cancers, explained Dr. Port, director of the Center of Excellence for Breast Cancer at The Tisch Cancer Institute at Mount Sinai.
Considering family history and genetics on both sides of the family is important when assessing cancer risk in men and women, Dr. Port said.
BRCA Mutations in Men: What’s the Risk?
Although fewer than 1% of all breast cancers occur in men, when men do carry a BRCA mutation, their risk for breast cancer can increase considerably. The lifetime risk for breast cancer can be as high as 9% in male BRCA2 carriers and up to 1.2% in BRCA1 carriers.
BRCA1/2 mutations also put men at increased risk for pancreatic and prostate cancers.
For pancreatic cancer, male BRCA1 carriers have a nearly twofold increased risk compared with the general population, with a lifetime risk of 3%. BRCA2 carriers have a three- to nearly eightfold increased risk, with a lifetime risk up to 7%.
Male BRCA1 carriers face a nearly fourfold increased risk of developing prostate cancer and an absolute lifetime risk of 15%-45%. Male BRCA2 carriers have a five- to ninefold increased risk for prostate cancer, with an absolute lifetime risk between 27% and 60%.
When to Test, When to Screen?
Despite the increased risk for several cancers associated with BRCA mutations, many men are not offered genetic testing.
BRCA1/2 genetic testing in men is “ultra-important but underutilized and is an evolving unmet need that the field needs to address,” Kai Tsao, MD MS, medical director of the Medical Oncology Prostate Cancer Program at Mount Sinai in New York City, told this news organization.
For men considering genetic testing, in Dr. Tsao’s experience, barriers may include fear that insurance may not cover the test and that a positive test may increase insurance premiums, as well as concerns about what the test result may mean for them and their family.
Even for confirmed BRCA carriers, cancer screening guidelines for men vary.
For breast screening in men, there’s limited data to inform guidelines. The National Cancer Center Network currently recommends breast awareness and teaching self-examination starting at age 35 and recommends men with BRCA variants consider yearly mammograms starting at age 50, or 10 years before the earliest male breast cancer diagnosis in the family.
Data show that screening mammography in men at high-risk for breast cancer yields similar cancer detection rates in men and women, “suggesting mammography screening may be valuable in male BRCA carriers,” the review authors noted. And, in a recent study of men with BRCA1/2 pathogenic variants, most (71%) recommended for screening mammography completed their screening.
The European Society for Medical Oncology (ESMO) has similar screening recommendations but focuses only on men with BRCA2 mutations and suggests breast ultrasonography as well as mammography as a screening option.
The larger “issue is the general population doesn’t think of breast cancer when they think of men, which may delay seeking medical attention,” said Melissa Fana, MD, of NYU Grossman Long Island School of Medicine and NYU Langone Health, who wasn’t involved in the review.
For pancreatic cancer, guidelines suggest BRCA1/2 carriers be screened for pancreatic cancer starting at age 50, or 10 years before the earliest known pancreatic cancer in the family, although the guidelines vary on the role family history should play.
And for prostate cancer, current guidelines recommend male BRCA carriers begin prostate-specific antigen screening between age 40 and 45 years, although recommendations on screening intervals and start age vary. ESMO recommendations are similar but only apply to BRCA2 carriers.
A male patient with a BRCA1/2 variant is typically referred for genetic counseling as well, Dr. Tsao explained. But “the challenge is that we don’t have a very good healthcare infrastructure right now” to follow through with that, he added. “Oftentimes a patient will wait many months or even more than a year for a genetic counseling appointment.”
To help improve these issues, Mount Sinai recently launched a comprehensive BRCA program for men and women that offers genetic testing and counseling for patients and family members.
Overall, identifying more male BRCA1/2 carriers will “maximize opportunities for cancer early detection, targeted risk management, and cancer treatment for males, along with facilitating opportunities for risk reduction and prevention in their family members, thereby decreasing the burden of hereditary cancer,” Dr. Cheng and colleagues concluded.
Support for the review was provided in part by BRCA Research and Cure Alliance and the Men & BRCA Program at the Basser Center for BRCA. Cheng reported grants from Promontory Pharmaceutics, Medivation, Sanofi, Janssen, royalties from UpToDate, nonfinancial support from Color Health, personal fees from AstraZeneca, BRCA Research and Cure Alliance (CureBRCA) outside the submitted work. Dr. Port, Dr. Tsao, and Dr. Fana had no conflicts of interest.
A version of this article first appeared on Medscape.com.
BRCA1 and BRCA2 pathogenic variants carry well-known associations with breast and ovarian cancers in women, which has led to robust clinical guidelines for early genetic testing and risk-reduction strategies.
Male carriers of BRCA1/2 pathogenic variants also face an increased risk for cancer, particularly of the prostate, pancreas, and breast.
However, men often fly under the radar.
“Most people (including their clinicians) are unaware of their carrier status,” Heather Cheng, MD, PhD, with University of Washington, Seattle, and colleagues explained in a comprehensive review on the subject, published in JAMA Oncology. Most are also unaware of “the associated cancer risks, and management recommendations” for BRCA carriers.
The testing gap in males may exist, in part, because of a “general lack of awareness” that BRCA gene mutations can be passed down to children from both the mother and father, Elisa Port, MD, chief of breast surgery for the Mount Sinai Health System in New York City, told this news organization.
A daughter can inherit a mutated BRCA gene that puts her at risk for breast or ovarian cancer from her mother’s or father’s family and, similarly, a son can inherit a mutated BRCA gene from either side of the family that puts him at an increased risk for developing prostate and other cancers, explained Dr. Port, director of the Center of Excellence for Breast Cancer at The Tisch Cancer Institute at Mount Sinai.
Considering family history and genetics on both sides of the family is important when assessing cancer risk in men and women, Dr. Port said.
BRCA Mutations in Men: What’s the Risk?
Although fewer than 1% of all breast cancers occur in men, when men do carry a BRCA mutation, their risk for breast cancer can increase considerably. The lifetime risk for breast cancer can be as high as 9% in male BRCA2 carriers and up to 1.2% in BRCA1 carriers.
BRCA1/2 mutations also put men at increased risk for pancreatic and prostate cancers.
For pancreatic cancer, male BRCA1 carriers have a nearly twofold increased risk compared with the general population, with a lifetime risk of 3%. BRCA2 carriers have a three- to nearly eightfold increased risk, with a lifetime risk up to 7%.
Male BRCA1 carriers face a nearly fourfold increased risk of developing prostate cancer and an absolute lifetime risk of 15%-45%. Male BRCA2 carriers have a five- to ninefold increased risk for prostate cancer, with an absolute lifetime risk between 27% and 60%.
When to Test, When to Screen?
Despite the increased risk for several cancers associated with BRCA mutations, many men are not offered genetic testing.
BRCA1/2 genetic testing in men is “ultra-important but underutilized and is an evolving unmet need that the field needs to address,” Kai Tsao, MD MS, medical director of the Medical Oncology Prostate Cancer Program at Mount Sinai in New York City, told this news organization.
For men considering genetic testing, in Dr. Tsao’s experience, barriers may include fear that insurance may not cover the test and that a positive test may increase insurance premiums, as well as concerns about what the test result may mean for them and their family.
Even for confirmed BRCA carriers, cancer screening guidelines for men vary.
For breast screening in men, there’s limited data to inform guidelines. The National Cancer Center Network currently recommends breast awareness and teaching self-examination starting at age 35 and recommends men with BRCA variants consider yearly mammograms starting at age 50, or 10 years before the earliest male breast cancer diagnosis in the family.
Data show that screening mammography in men at high-risk for breast cancer yields similar cancer detection rates in men and women, “suggesting mammography screening may be valuable in male BRCA carriers,” the review authors noted. And, in a recent study of men with BRCA1/2 pathogenic variants, most (71%) recommended for screening mammography completed their screening.
The European Society for Medical Oncology (ESMO) has similar screening recommendations but focuses only on men with BRCA2 mutations and suggests breast ultrasonography as well as mammography as a screening option.
The larger “issue is the general population doesn’t think of breast cancer when they think of men, which may delay seeking medical attention,” said Melissa Fana, MD, of NYU Grossman Long Island School of Medicine and NYU Langone Health, who wasn’t involved in the review.
For pancreatic cancer, guidelines suggest BRCA1/2 carriers be screened for pancreatic cancer starting at age 50, or 10 years before the earliest known pancreatic cancer in the family, although the guidelines vary on the role family history should play.
And for prostate cancer, current guidelines recommend male BRCA carriers begin prostate-specific antigen screening between age 40 and 45 years, although recommendations on screening intervals and start age vary. ESMO recommendations are similar but only apply to BRCA2 carriers.
A male patient with a BRCA1/2 variant is typically referred for genetic counseling as well, Dr. Tsao explained. But “the challenge is that we don’t have a very good healthcare infrastructure right now” to follow through with that, he added. “Oftentimes a patient will wait many months or even more than a year for a genetic counseling appointment.”
To help improve these issues, Mount Sinai recently launched a comprehensive BRCA program for men and women that offers genetic testing and counseling for patients and family members.
Overall, identifying more male BRCA1/2 carriers will “maximize opportunities for cancer early detection, targeted risk management, and cancer treatment for males, along with facilitating opportunities for risk reduction and prevention in their family members, thereby decreasing the burden of hereditary cancer,” Dr. Cheng and colleagues concluded.
Support for the review was provided in part by BRCA Research and Cure Alliance and the Men & BRCA Program at the Basser Center for BRCA. Cheng reported grants from Promontory Pharmaceutics, Medivation, Sanofi, Janssen, royalties from UpToDate, nonfinancial support from Color Health, personal fees from AstraZeneca, BRCA Research and Cure Alliance (CureBRCA) outside the submitted work. Dr. Port, Dr. Tsao, and Dr. Fana had no conflicts of interest.
A version of this article first appeared on Medscape.com.
FTC Interim Report on Pharmacy Middlemen Is First Step of Many Needed in Addressing Drug Costs, Access
Rising consolidation among pharmacy benefit managers (PBMs) allows the companies to profit at the expense of patients and independent pharmacists. That’s the conclusion of a recent Federal Trade Commission (FTC) report on interim findings from the agency’s ongoing investigation of PBMs.
Lawmakers are increasingly scrutinizing the industry amid growing concern among physicians and consumers about how PBMs exploit their market dominance. The top six PBMs managed 94% of US drug claims in 2023, with the majority handled by the industry’s three giants: CVS Caremark, Cigna’s Express Scripts, and United Healthcare’s OptumRx.
PBMs manage prescription drug benefits for health insurers, Medicare Part D drug plans, and large employers. They act as middlemen between health insurers and pharmacies, developing formularies of covered drugs and promising savings from the discounts and rebates they negotiate with drugmakers.
The FTC’s interim report found that the giant PBMs often exercise significant control over what drugs are available and at what price and which pharmacies patients can use to access their prescribed medications. Consumers suffer as a result, the report concluded.
Madelaine A. Feldman, MD, vice president for advocacy and government affairs for the Coalition of State Rheumatology Organizations, shared her perspective on the FTC report in an email Q&A with this news organization. She is affiliated with The Rheumatology Group, based in Metairie, Louisiana.
Dr. Feldman has long tracked the PBM industry and appeared as a witness before influential government panels, including the House Energy and Commerce Committee. She has highlighted for lawmakers the challenges physicians face in helping patients get needed medicines.
For example, she shared cases of PBMs steering patients toward the more expensive of three widely used rheumatoid arthritis medicines that have a similar mechanism of action, the Janus kinase (JAK) inhibitors, Dr. Feldman said.
One of the drugs cost roughly half of the other two — about $30,000 per year vs $65,000-$70,000. Yet only the two expensive drugs were included in the PBM formulary. As a result, the cheapest drug holds only a sliver of market share; the remainder is dominated by the two expensive products, she told the House Oversight and Accountability Committee in 2021.
This Q&A has been edited for length and clarity.
What would you want federal and state policymakers to do in response to the FTC’s report?
I think Congress needs to clearly delineate the differences between anticompetitive pharmacy issues, drug pricing issues, and their effect on formulary construction issues.
Lawmakers should demand more transparency and consider legislation that would remove perverse incentives that prompt PBMs to choose higher priced drugs for their formularies.
That may require other regulatory or legislative actions to ensure lower prices (not higher kickbacks) are incentivized. Ultimately, in order to gain true competition within the health insurance business, these oligopolies of multiple businesses need to be broken up. Anything less seems to be nibbling around the edges and allows the Big Three to continue their “whack-a mole” in circumventing piecemeal regulatory and legislative policies.
You’ve followed PBM practices closely for many years. Was there anything in this interim FTC report that surprised you?
Though not surprised, I am glad that it was released because it had been a year in investigation and there were many requests for some type of substantive report.
Two things that are missing that I feel are paramount are investigating how the three big PBMs are causing physical harm to patients as a result of the profit component in formulary construction and the profound financial impact of hidden PBM profit centers in self-insured employer health plans.
What we have seen over the years is the result of the perverse incentives for the PBMs to prefer the most profitable medications on their formularies.
They use utilization management tools such as step therapy, nonmedical switching, and exclusions to maintain their formularies’ profitability. These tools have been shown to delay and deny the proper care of patients, resulting in not just monetary but physical harm as well.
I would think the physical harm done to patients in manipulating the formularies should be addressed in this report as well and, in fact, may be the most important aspect of consumer protection of this issue.
In terms of the FTC’s mission to not “unduly burden” legitimate business, I would like to see the sector of self-insured employers addressed.
The report details how PBMs steer prescriptions to their affiliated pharmacies. The FTC says that can push smaller pharmacies out of the market, ultimately leading to higher costs and lower quality services for people. What’s your perspective?
Having more community pharmacies is better than having less. We are seeing more “pharmacy deserts” in rural areas as a result of many community pharmacies having to close.
The FTC voted 4-1 to allow staff to issue the interim report, with Commissioner Melissa Holyoak voting no. And some FTC commissioners seem divided on the usefulness of the report. Why?
Commissioner Holyoak states the “the Report leaves us without a better understanding of the competition concerns surrounding PBMs or how consumers are impacted by PBM practices.”
I do agree with her that the harm to patients’ medical status was not even addressed as far as I could tell in this report. There are multiple news articles and reports on the harms inflicted upon patients by the UM tools that drive the construction of ever changing formularies, all based on contracting with manufacturers that result in the highest profit for the PBM.
Holyoak also states, “Among other critical conclusions, the Report does not address the seemingly contradictory conclusions in the 2005 Report that PBMs, including vertically owned PBMs, generated cost savings for consumers.”
That may be true, but in 2005, the rise of PBMs was just beginning and the huge vertical and horizontal integration had yet to begin. Also, 2005 was still in the beginning of the biologic drug deluge, which did create competition to get on the formulary. Since then, PBMs have done nothing to control the rise in prices but instead, apparently have used the competition to get higher price concessions from manufacturers based on a percentage of the list price to line their pockets.
Commissioner Ferguson agreed with releasing the report but he had many issues with this report including the lack of PBM response.
I do agree with him that the FTC should have used some type of “force” to get the information they needed from the PBMs. The Big Three are known for obfuscation and delaying providing information to legislative and regulatory agencies.
A version of this article appeared on Medscape.com.
Rising consolidation among pharmacy benefit managers (PBMs) allows the companies to profit at the expense of patients and independent pharmacists. That’s the conclusion of a recent Federal Trade Commission (FTC) report on interim findings from the agency’s ongoing investigation of PBMs.
Lawmakers are increasingly scrutinizing the industry amid growing concern among physicians and consumers about how PBMs exploit their market dominance. The top six PBMs managed 94% of US drug claims in 2023, with the majority handled by the industry’s three giants: CVS Caremark, Cigna’s Express Scripts, and United Healthcare’s OptumRx.
PBMs manage prescription drug benefits for health insurers, Medicare Part D drug plans, and large employers. They act as middlemen between health insurers and pharmacies, developing formularies of covered drugs and promising savings from the discounts and rebates they negotiate with drugmakers.
The FTC’s interim report found that the giant PBMs often exercise significant control over what drugs are available and at what price and which pharmacies patients can use to access their prescribed medications. Consumers suffer as a result, the report concluded.
Madelaine A. Feldman, MD, vice president for advocacy and government affairs for the Coalition of State Rheumatology Organizations, shared her perspective on the FTC report in an email Q&A with this news organization. She is affiliated with The Rheumatology Group, based in Metairie, Louisiana.
Dr. Feldman has long tracked the PBM industry and appeared as a witness before influential government panels, including the House Energy and Commerce Committee. She has highlighted for lawmakers the challenges physicians face in helping patients get needed medicines.
For example, she shared cases of PBMs steering patients toward the more expensive of three widely used rheumatoid arthritis medicines that have a similar mechanism of action, the Janus kinase (JAK) inhibitors, Dr. Feldman said.
One of the drugs cost roughly half of the other two — about $30,000 per year vs $65,000-$70,000. Yet only the two expensive drugs were included in the PBM formulary. As a result, the cheapest drug holds only a sliver of market share; the remainder is dominated by the two expensive products, she told the House Oversight and Accountability Committee in 2021.
This Q&A has been edited for length and clarity.
What would you want federal and state policymakers to do in response to the FTC’s report?
I think Congress needs to clearly delineate the differences between anticompetitive pharmacy issues, drug pricing issues, and their effect on formulary construction issues.
Lawmakers should demand more transparency and consider legislation that would remove perverse incentives that prompt PBMs to choose higher priced drugs for their formularies.
That may require other regulatory or legislative actions to ensure lower prices (not higher kickbacks) are incentivized. Ultimately, in order to gain true competition within the health insurance business, these oligopolies of multiple businesses need to be broken up. Anything less seems to be nibbling around the edges and allows the Big Three to continue their “whack-a mole” in circumventing piecemeal regulatory and legislative policies.
You’ve followed PBM practices closely for many years. Was there anything in this interim FTC report that surprised you?
Though not surprised, I am glad that it was released because it had been a year in investigation and there were many requests for some type of substantive report.
Two things that are missing that I feel are paramount are investigating how the three big PBMs are causing physical harm to patients as a result of the profit component in formulary construction and the profound financial impact of hidden PBM profit centers in self-insured employer health plans.
What we have seen over the years is the result of the perverse incentives for the PBMs to prefer the most profitable medications on their formularies.
They use utilization management tools such as step therapy, nonmedical switching, and exclusions to maintain their formularies’ profitability. These tools have been shown to delay and deny the proper care of patients, resulting in not just monetary but physical harm as well.
I would think the physical harm done to patients in manipulating the formularies should be addressed in this report as well and, in fact, may be the most important aspect of consumer protection of this issue.
In terms of the FTC’s mission to not “unduly burden” legitimate business, I would like to see the sector of self-insured employers addressed.
The report details how PBMs steer prescriptions to their affiliated pharmacies. The FTC says that can push smaller pharmacies out of the market, ultimately leading to higher costs and lower quality services for people. What’s your perspective?
Having more community pharmacies is better than having less. We are seeing more “pharmacy deserts” in rural areas as a result of many community pharmacies having to close.
The FTC voted 4-1 to allow staff to issue the interim report, with Commissioner Melissa Holyoak voting no. And some FTC commissioners seem divided on the usefulness of the report. Why?
Commissioner Holyoak states the “the Report leaves us without a better understanding of the competition concerns surrounding PBMs or how consumers are impacted by PBM practices.”
I do agree with her that the harm to patients’ medical status was not even addressed as far as I could tell in this report. There are multiple news articles and reports on the harms inflicted upon patients by the UM tools that drive the construction of ever changing formularies, all based on contracting with manufacturers that result in the highest profit for the PBM.
Holyoak also states, “Among other critical conclusions, the Report does not address the seemingly contradictory conclusions in the 2005 Report that PBMs, including vertically owned PBMs, generated cost savings for consumers.”
That may be true, but in 2005, the rise of PBMs was just beginning and the huge vertical and horizontal integration had yet to begin. Also, 2005 was still in the beginning of the biologic drug deluge, which did create competition to get on the formulary. Since then, PBMs have done nothing to control the rise in prices but instead, apparently have used the competition to get higher price concessions from manufacturers based on a percentage of the list price to line their pockets.
Commissioner Ferguson agreed with releasing the report but he had many issues with this report including the lack of PBM response.
I do agree with him that the FTC should have used some type of “force” to get the information they needed from the PBMs. The Big Three are known for obfuscation and delaying providing information to legislative and regulatory agencies.
A version of this article appeared on Medscape.com.
Rising consolidation among pharmacy benefit managers (PBMs) allows the companies to profit at the expense of patients and independent pharmacists. That’s the conclusion of a recent Federal Trade Commission (FTC) report on interim findings from the agency’s ongoing investigation of PBMs.
Lawmakers are increasingly scrutinizing the industry amid growing concern among physicians and consumers about how PBMs exploit their market dominance. The top six PBMs managed 94% of US drug claims in 2023, with the majority handled by the industry’s three giants: CVS Caremark, Cigna’s Express Scripts, and United Healthcare’s OptumRx.
PBMs manage prescription drug benefits for health insurers, Medicare Part D drug plans, and large employers. They act as middlemen between health insurers and pharmacies, developing formularies of covered drugs and promising savings from the discounts and rebates they negotiate with drugmakers.
The FTC’s interim report found that the giant PBMs often exercise significant control over what drugs are available and at what price and which pharmacies patients can use to access their prescribed medications. Consumers suffer as a result, the report concluded.
Madelaine A. Feldman, MD, vice president for advocacy and government affairs for the Coalition of State Rheumatology Organizations, shared her perspective on the FTC report in an email Q&A with this news organization. She is affiliated with The Rheumatology Group, based in Metairie, Louisiana.
Dr. Feldman has long tracked the PBM industry and appeared as a witness before influential government panels, including the House Energy and Commerce Committee. She has highlighted for lawmakers the challenges physicians face in helping patients get needed medicines.
For example, she shared cases of PBMs steering patients toward the more expensive of three widely used rheumatoid arthritis medicines that have a similar mechanism of action, the Janus kinase (JAK) inhibitors, Dr. Feldman said.
One of the drugs cost roughly half of the other two — about $30,000 per year vs $65,000-$70,000. Yet only the two expensive drugs were included in the PBM formulary. As a result, the cheapest drug holds only a sliver of market share; the remainder is dominated by the two expensive products, she told the House Oversight and Accountability Committee in 2021.
This Q&A has been edited for length and clarity.
What would you want federal and state policymakers to do in response to the FTC’s report?
I think Congress needs to clearly delineate the differences between anticompetitive pharmacy issues, drug pricing issues, and their effect on formulary construction issues.
Lawmakers should demand more transparency and consider legislation that would remove perverse incentives that prompt PBMs to choose higher priced drugs for their formularies.
That may require other regulatory or legislative actions to ensure lower prices (not higher kickbacks) are incentivized. Ultimately, in order to gain true competition within the health insurance business, these oligopolies of multiple businesses need to be broken up. Anything less seems to be nibbling around the edges and allows the Big Three to continue their “whack-a mole” in circumventing piecemeal regulatory and legislative policies.
You’ve followed PBM practices closely for many years. Was there anything in this interim FTC report that surprised you?
Though not surprised, I am glad that it was released because it had been a year in investigation and there were many requests for some type of substantive report.
Two things that are missing that I feel are paramount are investigating how the three big PBMs are causing physical harm to patients as a result of the profit component in formulary construction and the profound financial impact of hidden PBM profit centers in self-insured employer health plans.
What we have seen over the years is the result of the perverse incentives for the PBMs to prefer the most profitable medications on their formularies.
They use utilization management tools such as step therapy, nonmedical switching, and exclusions to maintain their formularies’ profitability. These tools have been shown to delay and deny the proper care of patients, resulting in not just monetary but physical harm as well.
I would think the physical harm done to patients in manipulating the formularies should be addressed in this report as well and, in fact, may be the most important aspect of consumer protection of this issue.
In terms of the FTC’s mission to not “unduly burden” legitimate business, I would like to see the sector of self-insured employers addressed.
The report details how PBMs steer prescriptions to their affiliated pharmacies. The FTC says that can push smaller pharmacies out of the market, ultimately leading to higher costs and lower quality services for people. What’s your perspective?
Having more community pharmacies is better than having less. We are seeing more “pharmacy deserts” in rural areas as a result of many community pharmacies having to close.
The FTC voted 4-1 to allow staff to issue the interim report, with Commissioner Melissa Holyoak voting no. And some FTC commissioners seem divided on the usefulness of the report. Why?
Commissioner Holyoak states the “the Report leaves us without a better understanding of the competition concerns surrounding PBMs or how consumers are impacted by PBM practices.”
I do agree with her that the harm to patients’ medical status was not even addressed as far as I could tell in this report. There are multiple news articles and reports on the harms inflicted upon patients by the UM tools that drive the construction of ever changing formularies, all based on contracting with manufacturers that result in the highest profit for the PBM.
Holyoak also states, “Among other critical conclusions, the Report does not address the seemingly contradictory conclusions in the 2005 Report that PBMs, including vertically owned PBMs, generated cost savings for consumers.”
That may be true, but in 2005, the rise of PBMs was just beginning and the huge vertical and horizontal integration had yet to begin. Also, 2005 was still in the beginning of the biologic drug deluge, which did create competition to get on the formulary. Since then, PBMs have done nothing to control the rise in prices but instead, apparently have used the competition to get higher price concessions from manufacturers based on a percentage of the list price to line their pockets.
Commissioner Ferguson agreed with releasing the report but he had many issues with this report including the lack of PBM response.
I do agree with him that the FTC should have used some type of “force” to get the information they needed from the PBMs. The Big Three are known for obfuscation and delaying providing information to legislative and regulatory agencies.
A version of this article appeared on Medscape.com.
CBD Use in Pregnant People Double That of Nonpregnant Counterparts
Pregnant women in a large North American sample reported nearly double the rate of cannabidiol (CBD) use compared with nonpregnant women, new data published in a research letter in Obstetrics & Gynecology indicates.
Healthcare providers should be aware of the high rate of CBD use in pregnancy, especially as legal use of cannabis is increasing faster than evidence on outcomes for exposed offspring, note the researchers, led by Devika Bhatia, MD, from the Department of Psychiatry, Colorado School of Medicine, University of Colorado Anschutz Medical Campus in Aurora.
In an accompanying editorial, Torri D. Metz, MD, MS, deputy editor for obstetrics for Obstetrics & Gynecology, writes that the study “is critically important.” She points out that pregnant individuals may perceive that CBD is a safe drug to use in pregnancy, despite there being essentially no data examining whether or not this is the case.
Large Dataset From United States and Canada
Researchers used data from the International Cannabis Policy Study (2019-2021), a repeated cross-sectional survey of people aged 16-65 years in the United States and Canada. There were 66,457 women in the sample, including 1096 pregnant women.
Particularly concerning, the authors write, is the prenatal use of CBD-only products. Those products are advertised to contain only CBD, rather than tetrahydrocannabinol (THC). They point out CBD-only products are often legal in North America and often marketed as supplements.
The prevalence of CBD-only use in pregnant women in the study was 20.4% compared with 11.3% among nonpregnant women, P < .001. The top reason for use by pregnant women was anxiety (58.4%). Other top reasons included depression (40.3%), posttraumatic stress disorder (32.1%), pain (52.3%), headache (35.6%), and nausea or vomiting (31.9%).
“Nonpregnant women were significantly more likely to report using CBD for pain, sleep, general well-being, and ‘other’ physical or mental health reasons, or to not use CBD for mental health,” the authors write, adding that the reasons for CBD use highlight drivers that may be important to address in treating pregnant patients.
Provider Endorsement in Some Cases
Dr. Metz, associate professor of obstetrics and gynecology with the University of Utah Health in Salt Lake City, says in some cases women may be getting endorsement of CBD use from their provider or at least implied support when CBD is prescribed. In the study, pregnant women had 2.33 times greater adjusted odds of having a CBD prescription than nonpregnant women (95% confidence interval, 1.27-2.88).
She points to another cross-sectional study of more than 10,000 participants using PRAMS (Pregnancy Risk Assessment Monitoring System) data that found that “from 2017 to 2019, 63% of pregnant women reported that they were not told to avoid cannabis use in pregnancy, and 8% noted that they were advised to use cannabis by their prenatal care practitioner.”
The American College of Obstetricians and Gynecologists recommends against prescribing cannabis products for pregnant or lactating women.
Studies that have explored THC and its metabolites have shown “a consistent association between cannabis use and decreased fetal growth,” Dr. Metz noted. “There also remain persistent concerns about the long-term neurodevelopmental effects of maternal cannabis use on the fetus and, subsequently, the newborn.”
Limitations of the study include the self-reported responses and participants’ ability to accurately distinguish between CBD-only and THC-containing products.
Because self-reports of CBD use in pregnancy may be drastically underestimated and nonreliable, Dr. Metz writes, development of blood and urine screens to help detect CBD product use “will be helpful in moving the field forward.”
Study senior author David Hammond, PhD, has been a paid expert witness on behalf of public health authorities in response to legal challenges from the cannabis, tobacco, vaping, and food industries. Other authors did not report any potential conflicts. Dr. Metz reports personal fees from Pfizer, and grants from Pfizer for her role as a site principal investigator for SARS-CoV-2 vaccination and for her role as a site PI for RSV vaccination in pregnancy study.
Pregnant women in a large North American sample reported nearly double the rate of cannabidiol (CBD) use compared with nonpregnant women, new data published in a research letter in Obstetrics & Gynecology indicates.
Healthcare providers should be aware of the high rate of CBD use in pregnancy, especially as legal use of cannabis is increasing faster than evidence on outcomes for exposed offspring, note the researchers, led by Devika Bhatia, MD, from the Department of Psychiatry, Colorado School of Medicine, University of Colorado Anschutz Medical Campus in Aurora.
In an accompanying editorial, Torri D. Metz, MD, MS, deputy editor for obstetrics for Obstetrics & Gynecology, writes that the study “is critically important.” She points out that pregnant individuals may perceive that CBD is a safe drug to use in pregnancy, despite there being essentially no data examining whether or not this is the case.
Large Dataset From United States and Canada
Researchers used data from the International Cannabis Policy Study (2019-2021), a repeated cross-sectional survey of people aged 16-65 years in the United States and Canada. There were 66,457 women in the sample, including 1096 pregnant women.
Particularly concerning, the authors write, is the prenatal use of CBD-only products. Those products are advertised to contain only CBD, rather than tetrahydrocannabinol (THC). They point out CBD-only products are often legal in North America and often marketed as supplements.
The prevalence of CBD-only use in pregnant women in the study was 20.4% compared with 11.3% among nonpregnant women, P < .001. The top reason for use by pregnant women was anxiety (58.4%). Other top reasons included depression (40.3%), posttraumatic stress disorder (32.1%), pain (52.3%), headache (35.6%), and nausea or vomiting (31.9%).
“Nonpregnant women were significantly more likely to report using CBD for pain, sleep, general well-being, and ‘other’ physical or mental health reasons, or to not use CBD for mental health,” the authors write, adding that the reasons for CBD use highlight drivers that may be important to address in treating pregnant patients.
Provider Endorsement in Some Cases
Dr. Metz, associate professor of obstetrics and gynecology with the University of Utah Health in Salt Lake City, says in some cases women may be getting endorsement of CBD use from their provider or at least implied support when CBD is prescribed. In the study, pregnant women had 2.33 times greater adjusted odds of having a CBD prescription than nonpregnant women (95% confidence interval, 1.27-2.88).
She points to another cross-sectional study of more than 10,000 participants using PRAMS (Pregnancy Risk Assessment Monitoring System) data that found that “from 2017 to 2019, 63% of pregnant women reported that they were not told to avoid cannabis use in pregnancy, and 8% noted that they were advised to use cannabis by their prenatal care practitioner.”
The American College of Obstetricians and Gynecologists recommends against prescribing cannabis products for pregnant or lactating women.
Studies that have explored THC and its metabolites have shown “a consistent association between cannabis use and decreased fetal growth,” Dr. Metz noted. “There also remain persistent concerns about the long-term neurodevelopmental effects of maternal cannabis use on the fetus and, subsequently, the newborn.”
Limitations of the study include the self-reported responses and participants’ ability to accurately distinguish between CBD-only and THC-containing products.
Because self-reports of CBD use in pregnancy may be drastically underestimated and nonreliable, Dr. Metz writes, development of blood and urine screens to help detect CBD product use “will be helpful in moving the field forward.”
Study senior author David Hammond, PhD, has been a paid expert witness on behalf of public health authorities in response to legal challenges from the cannabis, tobacco, vaping, and food industries. Other authors did not report any potential conflicts. Dr. Metz reports personal fees from Pfizer, and grants from Pfizer for her role as a site principal investigator for SARS-CoV-2 vaccination and for her role as a site PI for RSV vaccination in pregnancy study.
Pregnant women in a large North American sample reported nearly double the rate of cannabidiol (CBD) use compared with nonpregnant women, new data published in a research letter in Obstetrics & Gynecology indicates.
Healthcare providers should be aware of the high rate of CBD use in pregnancy, especially as legal use of cannabis is increasing faster than evidence on outcomes for exposed offspring, note the researchers, led by Devika Bhatia, MD, from the Department of Psychiatry, Colorado School of Medicine, University of Colorado Anschutz Medical Campus in Aurora.
In an accompanying editorial, Torri D. Metz, MD, MS, deputy editor for obstetrics for Obstetrics & Gynecology, writes that the study “is critically important.” She points out that pregnant individuals may perceive that CBD is a safe drug to use in pregnancy, despite there being essentially no data examining whether or not this is the case.
Large Dataset From United States and Canada
Researchers used data from the International Cannabis Policy Study (2019-2021), a repeated cross-sectional survey of people aged 16-65 years in the United States and Canada. There were 66,457 women in the sample, including 1096 pregnant women.
Particularly concerning, the authors write, is the prenatal use of CBD-only products. Those products are advertised to contain only CBD, rather than tetrahydrocannabinol (THC). They point out CBD-only products are often legal in North America and often marketed as supplements.
The prevalence of CBD-only use in pregnant women in the study was 20.4% compared with 11.3% among nonpregnant women, P < .001. The top reason for use by pregnant women was anxiety (58.4%). Other top reasons included depression (40.3%), posttraumatic stress disorder (32.1%), pain (52.3%), headache (35.6%), and nausea or vomiting (31.9%).
“Nonpregnant women were significantly more likely to report using CBD for pain, sleep, general well-being, and ‘other’ physical or mental health reasons, or to not use CBD for mental health,” the authors write, adding that the reasons for CBD use highlight drivers that may be important to address in treating pregnant patients.
Provider Endorsement in Some Cases
Dr. Metz, associate professor of obstetrics and gynecology with the University of Utah Health in Salt Lake City, says in some cases women may be getting endorsement of CBD use from their provider or at least implied support when CBD is prescribed. In the study, pregnant women had 2.33 times greater adjusted odds of having a CBD prescription than nonpregnant women (95% confidence interval, 1.27-2.88).
She points to another cross-sectional study of more than 10,000 participants using PRAMS (Pregnancy Risk Assessment Monitoring System) data that found that “from 2017 to 2019, 63% of pregnant women reported that they were not told to avoid cannabis use in pregnancy, and 8% noted that they were advised to use cannabis by their prenatal care practitioner.”
The American College of Obstetricians and Gynecologists recommends against prescribing cannabis products for pregnant or lactating women.
Studies that have explored THC and its metabolites have shown “a consistent association between cannabis use and decreased fetal growth,” Dr. Metz noted. “There also remain persistent concerns about the long-term neurodevelopmental effects of maternal cannabis use on the fetus and, subsequently, the newborn.”
Limitations of the study include the self-reported responses and participants’ ability to accurately distinguish between CBD-only and THC-containing products.
Because self-reports of CBD use in pregnancy may be drastically underestimated and nonreliable, Dr. Metz writes, development of blood and urine screens to help detect CBD product use “will be helpful in moving the field forward.”
Study senior author David Hammond, PhD, has been a paid expert witness on behalf of public health authorities in response to legal challenges from the cannabis, tobacco, vaping, and food industries. Other authors did not report any potential conflicts. Dr. Metz reports personal fees from Pfizer, and grants from Pfizer for her role as a site principal investigator for SARS-CoV-2 vaccination and for her role as a site PI for RSV vaccination in pregnancy study.
FROM OBSTETRICS & GYNECOLOGY