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Much work to be done in optimizing treatment for transgender children
ORLANDO – Janet Y. Lee, MD, MPH, said at the annual meeting of the American Society for Bone and Mineral Research.
According to a report from The Williams Institute in 2017, there were approximately 150,000 youth in the United States who identified as transgender, and among studies that measured transgender identity among youth, the percentage who identified as transgender ranged between 1.3% and 3.2% (Herman J et al. “Age of Individuals who Identify as Transgender in the United States.” Los Angeles: The Williams Institute, January 2017).
“If you’ve not seen one of these patients yet, you probably will in your career,” said Dr. Lee of the University of California, San Francisco.
At UCSF, Dr. Lee said the focus of care for transgender youth in early childhood to late childhood is on school resources and social transition, with puberty blockers such as gonadotropin-releasing hormone agents (GnRHa) beginning in late childhood and early puberty at Tanner stage 2. When patients reach early puberty and move to late puberty and adulthood, they usually begin gender-affirming sex hormones such as testosterone for masculinizing hormone therapy or estrogen and spironolactone or bicalutamide for feminizing hormone therapy in transgender women, and consideration of fertility preservation is undertaken. In adulthood, patients can begin gender-affirming surgery.
Dr. Lee said the specific timing of gender-affirming sex hormones is controversial and “seems to be a moving target in our field.” The average age to begin gender-affirming sex hormones at UCSF is 14 years old, but sometimes younger, said Dr. Lee. There also is a question of when to start gender-affirming sex hormones in gender diverse youth. “[They] may not want full adult doses of testosterone or full adult doses of estradiol,” said Dr. Lee. “It’s been very challenging to figure out [appropriate] treatment for these youth.”
In Europe, some studies have shown transwomen have lower bone mineral density (BMD) scores at baseline even after 2.5 years to 5 years of treatment with estradiol, compared with male reference standards. A study by Vlot et al. found transwomen had lower bone turnover markers and bone mineral apparent density in cohorts younger than 15 years old, compared with cohorts 15 years or older (Bone. 2017 Feb. doi: 10.1016/j.bone.2016.11.008).
As in the case of when to start gender-affirming sex hormones, how to approach treatment for gender diverse youth who have a low baseline BMD but are eligible for puberty blockers is debated. “We could go into a whole other talk about this because we have many [patients] who present with low baseline BMD,” said Dr. Lee. “We have to figure out a way to apply treatment without impairing their bone.”
Other questions that have yet to be answered are what dual x-ray absorptiometry standards to be used for transgender individuals and how body composition and height growth are affected by gender-affirming medical therapy, which is currently “really modeled after hypergonadic children,” said Dr. Lee.
Results from a National Institutes of Health–funded longitudinal observational study of transgender youth at UCSF, Children’s Hospital Los Angeles, Boston Children’s Hospital, and Ann & Robert H. Lurie Children’s Hospital of Chicago is currently examining the effect of using gender-affirming medical treatment for patients in early and late puberty and assessing factors such as mental health, psychological well-being, and bone health measures such as dual x-ray absorptiometry and quantitative computed tomography, as well as investigating dietary intake, physical activity and exercise, and vitamin D status. Preliminary findings from the study have shown low BMD z-scores in designated males at birth when compared with designated females at birth, with suboptimal dietary calcium intake in both designated males and designated females.
Dr. Lee reported no relevant conflicts of interest.
ORLANDO – Janet Y. Lee, MD, MPH, said at the annual meeting of the American Society for Bone and Mineral Research.
According to a report from The Williams Institute in 2017, there were approximately 150,000 youth in the United States who identified as transgender, and among studies that measured transgender identity among youth, the percentage who identified as transgender ranged between 1.3% and 3.2% (Herman J et al. “Age of Individuals who Identify as Transgender in the United States.” Los Angeles: The Williams Institute, January 2017).
“If you’ve not seen one of these patients yet, you probably will in your career,” said Dr. Lee of the University of California, San Francisco.
At UCSF, Dr. Lee said the focus of care for transgender youth in early childhood to late childhood is on school resources and social transition, with puberty blockers such as gonadotropin-releasing hormone agents (GnRHa) beginning in late childhood and early puberty at Tanner stage 2. When patients reach early puberty and move to late puberty and adulthood, they usually begin gender-affirming sex hormones such as testosterone for masculinizing hormone therapy or estrogen and spironolactone or bicalutamide for feminizing hormone therapy in transgender women, and consideration of fertility preservation is undertaken. In adulthood, patients can begin gender-affirming surgery.
Dr. Lee said the specific timing of gender-affirming sex hormones is controversial and “seems to be a moving target in our field.” The average age to begin gender-affirming sex hormones at UCSF is 14 years old, but sometimes younger, said Dr. Lee. There also is a question of when to start gender-affirming sex hormones in gender diverse youth. “[They] may not want full adult doses of testosterone or full adult doses of estradiol,” said Dr. Lee. “It’s been very challenging to figure out [appropriate] treatment for these youth.”
In Europe, some studies have shown transwomen have lower bone mineral density (BMD) scores at baseline even after 2.5 years to 5 years of treatment with estradiol, compared with male reference standards. A study by Vlot et al. found transwomen had lower bone turnover markers and bone mineral apparent density in cohorts younger than 15 years old, compared with cohorts 15 years or older (Bone. 2017 Feb. doi: 10.1016/j.bone.2016.11.008).
As in the case of when to start gender-affirming sex hormones, how to approach treatment for gender diverse youth who have a low baseline BMD but are eligible for puberty blockers is debated. “We could go into a whole other talk about this because we have many [patients] who present with low baseline BMD,” said Dr. Lee. “We have to figure out a way to apply treatment without impairing their bone.”
Other questions that have yet to be answered are what dual x-ray absorptiometry standards to be used for transgender individuals and how body composition and height growth are affected by gender-affirming medical therapy, which is currently “really modeled after hypergonadic children,” said Dr. Lee.
Results from a National Institutes of Health–funded longitudinal observational study of transgender youth at UCSF, Children’s Hospital Los Angeles, Boston Children’s Hospital, and Ann & Robert H. Lurie Children’s Hospital of Chicago is currently examining the effect of using gender-affirming medical treatment for patients in early and late puberty and assessing factors such as mental health, psychological well-being, and bone health measures such as dual x-ray absorptiometry and quantitative computed tomography, as well as investigating dietary intake, physical activity and exercise, and vitamin D status. Preliminary findings from the study have shown low BMD z-scores in designated males at birth when compared with designated females at birth, with suboptimal dietary calcium intake in both designated males and designated females.
Dr. Lee reported no relevant conflicts of interest.
ORLANDO – Janet Y. Lee, MD, MPH, said at the annual meeting of the American Society for Bone and Mineral Research.
According to a report from The Williams Institute in 2017, there were approximately 150,000 youth in the United States who identified as transgender, and among studies that measured transgender identity among youth, the percentage who identified as transgender ranged between 1.3% and 3.2% (Herman J et al. “Age of Individuals who Identify as Transgender in the United States.” Los Angeles: The Williams Institute, January 2017).
“If you’ve not seen one of these patients yet, you probably will in your career,” said Dr. Lee of the University of California, San Francisco.
At UCSF, Dr. Lee said the focus of care for transgender youth in early childhood to late childhood is on school resources and social transition, with puberty blockers such as gonadotropin-releasing hormone agents (GnRHa) beginning in late childhood and early puberty at Tanner stage 2. When patients reach early puberty and move to late puberty and adulthood, they usually begin gender-affirming sex hormones such as testosterone for masculinizing hormone therapy or estrogen and spironolactone or bicalutamide for feminizing hormone therapy in transgender women, and consideration of fertility preservation is undertaken. In adulthood, patients can begin gender-affirming surgery.
Dr. Lee said the specific timing of gender-affirming sex hormones is controversial and “seems to be a moving target in our field.” The average age to begin gender-affirming sex hormones at UCSF is 14 years old, but sometimes younger, said Dr. Lee. There also is a question of when to start gender-affirming sex hormones in gender diverse youth. “[They] may not want full adult doses of testosterone or full adult doses of estradiol,” said Dr. Lee. “It’s been very challenging to figure out [appropriate] treatment for these youth.”
In Europe, some studies have shown transwomen have lower bone mineral density (BMD) scores at baseline even after 2.5 years to 5 years of treatment with estradiol, compared with male reference standards. A study by Vlot et al. found transwomen had lower bone turnover markers and bone mineral apparent density in cohorts younger than 15 years old, compared with cohorts 15 years or older (Bone. 2017 Feb. doi: 10.1016/j.bone.2016.11.008).
As in the case of when to start gender-affirming sex hormones, how to approach treatment for gender diverse youth who have a low baseline BMD but are eligible for puberty blockers is debated. “We could go into a whole other talk about this because we have many [patients] who present with low baseline BMD,” said Dr. Lee. “We have to figure out a way to apply treatment without impairing their bone.”
Other questions that have yet to be answered are what dual x-ray absorptiometry standards to be used for transgender individuals and how body composition and height growth are affected by gender-affirming medical therapy, which is currently “really modeled after hypergonadic children,” said Dr. Lee.
Results from a National Institutes of Health–funded longitudinal observational study of transgender youth at UCSF, Children’s Hospital Los Angeles, Boston Children’s Hospital, and Ann & Robert H. Lurie Children’s Hospital of Chicago is currently examining the effect of using gender-affirming medical treatment for patients in early and late puberty and assessing factors such as mental health, psychological well-being, and bone health measures such as dual x-ray absorptiometry and quantitative computed tomography, as well as investigating dietary intake, physical activity and exercise, and vitamin D status. Preliminary findings from the study have shown low BMD z-scores in designated males at birth when compared with designated females at birth, with suboptimal dietary calcium intake in both designated males and designated females.
Dr. Lee reported no relevant conflicts of interest.
EXPERT ANALYSIS FROM ASBMR 2019
Meeting the obstetrical needs of trans and gender nonconforming patients
Like their cisgender counterparts, transgender and gender nonconforming patients (trans patients) may reach a point in their lives where they want to build their own families. This may be achieved through adoption, alternative insemination with donor sperm, or assisted reproductive treatment with donor sperm or egg, cryopreserved sperm or egg, or surrogacy.1 Obstetricians can provide more equitable care to trans individuals by acknowledging these needs and providing gender-inclusive counseling and guidance.
The American Society for Reproductive Medicine recommends that medical providers counsel patients about the potential effects of medical transitioning on their fertility prior to the initiation of hormonal or surgical therapies.2 Patients should be educated about options for fertility preservation and reproduction since exogenous hormones and gonadectomy impact fertility.3 A referral to a fertility specialist should be placed for patients interested in oocyte or sperm cryopreservation, embryo cryopreservation, or ovarian tissue cryopreservation.2
If a trans patient presents to the obstetrician/gynecologist for preconception counseling after undergoing medical gender transition, they should be offered evidence-based guidance based on an organ inventory (surgical history with documentation of natal sex organs still in situ). A biologic pregnancy may be a fertility option for a patient who has a vagina, uterus, fallopian tubes, and ovaries and is not currently using testosterone. Gender-affirming testosterone therapy suppresses ovulation and causes amenorrhea in most patients, although this is often reversible once the exogenous hormone is discontinued.2 When the patient is ovulating on their own or undergoes ovulation induction, conception may be achieved via the same methods used with cisgender couples: Sperm is obtained from a partner or donor, followed by intercourse if the patient is comfortable with this, intrauterine insemination (IUI), or in vitro fertilization (IVF).
Conversely, a trans patient with a penis and testicles who has already undergone medical gender affirmation with estrogen should be counseled that prior exposure to estrogen may have caused irreversible testicular damage, making assisted reproductive treatment more challenging if sperm had not been cryopreserved prior to starting gender-affirming hormone therapy.2 If spermatogenesis is successful or sperm was previously cryopreserved, the next step in reproductive counseling for these patients centers on finding gestational carriers and egg donors if the patient does not already have a partner who is willing or able to carry the child. At this point in time, uterine transplantation has not been attempted in a trans patient and therefore is not considered a viable fertility option.
The trans patient who becomes pregnant will encounter physical changes that may trigger underlying gender dysphoria. One study found that transgender men who experience pregnancy exhibited varying degrees of gender dysphoria.4 Obstetrician/gynecologists should have an awareness about the possibility of heightened gender dysphoria and sensitively approach prenatal visits by avoiding triggering language or using inappropriate pronouns. Simply asking a trans patient about preferred pronouns and terminology for body parts can be the difference between a negative and positive pregnancy experience. For example, a transman may prefer a different term for vagina/vulva/cervix. This is especially important at the time of delivery, when exams may become more frequent for the patient. However, inclusive prenatal care starts from the first prenatal visit when the patient checks in and continues all the way through the doctor/patient experience. All office staff should be trained to use preferred names and pronouns and gender-neutral restrooms should be easily accessible. Likewise, waiting rooms should include visible support for the LGBTQ (lesbian, gay, bisexual, transgender and queer or questioning) patient population.
The anatomy ultrasound and “gender reveal” during the pregnancy and at the time of delivery can understandably also be a sensitive subject for a pregnant trans patient. Previous cultural practice has been to describe the gender of the fetus at the anatomy ultrasound, when in fact, gender can only be self-determined by an individual many years after birth. What the anatomy ultrasound does convey is the appearance of external genitalia to help predict the assigned sex. As obstetrician/gynecologists who practice evidence-based medicine, we are encouraged to challenge the cultural norm of announcing the gender of the baby at time of ultrasound and at time of birth. We should focus instead on conveying what objective information we do know. After the infant is born, we know the sex they are assigned based on the what external reproductive organs are seen.
In the postpartum period, trans patients who successfully carried a pregnancy may choose to feed their infant with their own human milk. For some trans patients, breastfeeding may be referred to as chestfeeding, since this terminology is more gender neutral. Having prior chest masculinization surgery does not exclude a transmasculine patient from lactating, although milk production may vary. Patients should be counseled that there is limited data on the safety of testosterone use while lactating.1 We found only one case report of induced lactation in a nonpuerperal transfeminine patient.5 In addition to addressing infant feeding concerns, obstetrician/gynecologists should counsel postpartum trans patients about contraceptive options and screen for perinatal mood disorders, especially those patients with a history of mood disorders before pregnancy.
Ultimately, trans patients seeking fertility options and obstetrical care have a right to obtain reliable information and access gender-inclusive treatment from their obstetrician/gynecologists. Each family makeup is unique and should be respected by all health care professionals taking care of the patient. As obstetrician/gynecologists, it is our duty to coordinate and advocate for the equitable care of our trans patients who want to grow their families.
Dr. Joyner is an assistant professor at Emory University, Atlanta, and is the director of gynecologic services in the Gender Center at Grady Memorial Hospital in Atlanta. Dr. Joyner identifies as a cisgender female and uses she/hers/her as her personal pronouns. Dr. Katie Riddle is an ob.gyn. in Connecticut who is passionate about LGBTQ health care. She recently completed her residency in Ann Arbor, Mich. Dr. Riddle identifies as a cisgender female and uses she/hers/her as her personal pronouns. Dr. Joyner and Dr. Riddle said they had no financial disclosures. Email them at [email protected].
References
1. Viloria RP. “Reproductive Health and Obstetric Care in Transgender Patients.” Fenway Health.
2. Amato P. “Fertility options for transgender persons.” University of California, San Francisco Transgender Care and Treatment Guidelines. 2016 Jun 17.
3. Fertil Steril. 2015 Nov. doi: 10.1016/j.fertnstert.2015.08.021.
4. Obstet Gynecol. 2014. doi: 10.1097/AOG.0000000000000540.
5. Transgend Health. 2018 Jan 1. doi: 10.1089/trgh.2017.0044.
Like their cisgender counterparts, transgender and gender nonconforming patients (trans patients) may reach a point in their lives where they want to build their own families. This may be achieved through adoption, alternative insemination with donor sperm, or assisted reproductive treatment with donor sperm or egg, cryopreserved sperm or egg, or surrogacy.1 Obstetricians can provide more equitable care to trans individuals by acknowledging these needs and providing gender-inclusive counseling and guidance.
The American Society for Reproductive Medicine recommends that medical providers counsel patients about the potential effects of medical transitioning on their fertility prior to the initiation of hormonal or surgical therapies.2 Patients should be educated about options for fertility preservation and reproduction since exogenous hormones and gonadectomy impact fertility.3 A referral to a fertility specialist should be placed for patients interested in oocyte or sperm cryopreservation, embryo cryopreservation, or ovarian tissue cryopreservation.2
If a trans patient presents to the obstetrician/gynecologist for preconception counseling after undergoing medical gender transition, they should be offered evidence-based guidance based on an organ inventory (surgical history with documentation of natal sex organs still in situ). A biologic pregnancy may be a fertility option for a patient who has a vagina, uterus, fallopian tubes, and ovaries and is not currently using testosterone. Gender-affirming testosterone therapy suppresses ovulation and causes amenorrhea in most patients, although this is often reversible once the exogenous hormone is discontinued.2 When the patient is ovulating on their own or undergoes ovulation induction, conception may be achieved via the same methods used with cisgender couples: Sperm is obtained from a partner or donor, followed by intercourse if the patient is comfortable with this, intrauterine insemination (IUI), or in vitro fertilization (IVF).
Conversely, a trans patient with a penis and testicles who has already undergone medical gender affirmation with estrogen should be counseled that prior exposure to estrogen may have caused irreversible testicular damage, making assisted reproductive treatment more challenging if sperm had not been cryopreserved prior to starting gender-affirming hormone therapy.2 If spermatogenesis is successful or sperm was previously cryopreserved, the next step in reproductive counseling for these patients centers on finding gestational carriers and egg donors if the patient does not already have a partner who is willing or able to carry the child. At this point in time, uterine transplantation has not been attempted in a trans patient and therefore is not considered a viable fertility option.
The trans patient who becomes pregnant will encounter physical changes that may trigger underlying gender dysphoria. One study found that transgender men who experience pregnancy exhibited varying degrees of gender dysphoria.4 Obstetrician/gynecologists should have an awareness about the possibility of heightened gender dysphoria and sensitively approach prenatal visits by avoiding triggering language or using inappropriate pronouns. Simply asking a trans patient about preferred pronouns and terminology for body parts can be the difference between a negative and positive pregnancy experience. For example, a transman may prefer a different term for vagina/vulva/cervix. This is especially important at the time of delivery, when exams may become more frequent for the patient. However, inclusive prenatal care starts from the first prenatal visit when the patient checks in and continues all the way through the doctor/patient experience. All office staff should be trained to use preferred names and pronouns and gender-neutral restrooms should be easily accessible. Likewise, waiting rooms should include visible support for the LGBTQ (lesbian, gay, bisexual, transgender and queer or questioning) patient population.
The anatomy ultrasound and “gender reveal” during the pregnancy and at the time of delivery can understandably also be a sensitive subject for a pregnant trans patient. Previous cultural practice has been to describe the gender of the fetus at the anatomy ultrasound, when in fact, gender can only be self-determined by an individual many years after birth. What the anatomy ultrasound does convey is the appearance of external genitalia to help predict the assigned sex. As obstetrician/gynecologists who practice evidence-based medicine, we are encouraged to challenge the cultural norm of announcing the gender of the baby at time of ultrasound and at time of birth. We should focus instead on conveying what objective information we do know. After the infant is born, we know the sex they are assigned based on the what external reproductive organs are seen.
In the postpartum period, trans patients who successfully carried a pregnancy may choose to feed their infant with their own human milk. For some trans patients, breastfeeding may be referred to as chestfeeding, since this terminology is more gender neutral. Having prior chest masculinization surgery does not exclude a transmasculine patient from lactating, although milk production may vary. Patients should be counseled that there is limited data on the safety of testosterone use while lactating.1 We found only one case report of induced lactation in a nonpuerperal transfeminine patient.5 In addition to addressing infant feeding concerns, obstetrician/gynecologists should counsel postpartum trans patients about contraceptive options and screen for perinatal mood disorders, especially those patients with a history of mood disorders before pregnancy.
Ultimately, trans patients seeking fertility options and obstetrical care have a right to obtain reliable information and access gender-inclusive treatment from their obstetrician/gynecologists. Each family makeup is unique and should be respected by all health care professionals taking care of the patient. As obstetrician/gynecologists, it is our duty to coordinate and advocate for the equitable care of our trans patients who want to grow their families.
Dr. Joyner is an assistant professor at Emory University, Atlanta, and is the director of gynecologic services in the Gender Center at Grady Memorial Hospital in Atlanta. Dr. Joyner identifies as a cisgender female and uses she/hers/her as her personal pronouns. Dr. Katie Riddle is an ob.gyn. in Connecticut who is passionate about LGBTQ health care. She recently completed her residency in Ann Arbor, Mich. Dr. Riddle identifies as a cisgender female and uses she/hers/her as her personal pronouns. Dr. Joyner and Dr. Riddle said they had no financial disclosures. Email them at [email protected].
References
1. Viloria RP. “Reproductive Health and Obstetric Care in Transgender Patients.” Fenway Health.
2. Amato P. “Fertility options for transgender persons.” University of California, San Francisco Transgender Care and Treatment Guidelines. 2016 Jun 17.
3. Fertil Steril. 2015 Nov. doi: 10.1016/j.fertnstert.2015.08.021.
4. Obstet Gynecol. 2014. doi: 10.1097/AOG.0000000000000540.
5. Transgend Health. 2018 Jan 1. doi: 10.1089/trgh.2017.0044.
Like their cisgender counterparts, transgender and gender nonconforming patients (trans patients) may reach a point in their lives where they want to build their own families. This may be achieved through adoption, alternative insemination with donor sperm, or assisted reproductive treatment with donor sperm or egg, cryopreserved sperm or egg, or surrogacy.1 Obstetricians can provide more equitable care to trans individuals by acknowledging these needs and providing gender-inclusive counseling and guidance.
The American Society for Reproductive Medicine recommends that medical providers counsel patients about the potential effects of medical transitioning on their fertility prior to the initiation of hormonal or surgical therapies.2 Patients should be educated about options for fertility preservation and reproduction since exogenous hormones and gonadectomy impact fertility.3 A referral to a fertility specialist should be placed for patients interested in oocyte or sperm cryopreservation, embryo cryopreservation, or ovarian tissue cryopreservation.2
If a trans patient presents to the obstetrician/gynecologist for preconception counseling after undergoing medical gender transition, they should be offered evidence-based guidance based on an organ inventory (surgical history with documentation of natal sex organs still in situ). A biologic pregnancy may be a fertility option for a patient who has a vagina, uterus, fallopian tubes, and ovaries and is not currently using testosterone. Gender-affirming testosterone therapy suppresses ovulation and causes amenorrhea in most patients, although this is often reversible once the exogenous hormone is discontinued.2 When the patient is ovulating on their own or undergoes ovulation induction, conception may be achieved via the same methods used with cisgender couples: Sperm is obtained from a partner or donor, followed by intercourse if the patient is comfortable with this, intrauterine insemination (IUI), or in vitro fertilization (IVF).
Conversely, a trans patient with a penis and testicles who has already undergone medical gender affirmation with estrogen should be counseled that prior exposure to estrogen may have caused irreversible testicular damage, making assisted reproductive treatment more challenging if sperm had not been cryopreserved prior to starting gender-affirming hormone therapy.2 If spermatogenesis is successful or sperm was previously cryopreserved, the next step in reproductive counseling for these patients centers on finding gestational carriers and egg donors if the patient does not already have a partner who is willing or able to carry the child. At this point in time, uterine transplantation has not been attempted in a trans patient and therefore is not considered a viable fertility option.
The trans patient who becomes pregnant will encounter physical changes that may trigger underlying gender dysphoria. One study found that transgender men who experience pregnancy exhibited varying degrees of gender dysphoria.4 Obstetrician/gynecologists should have an awareness about the possibility of heightened gender dysphoria and sensitively approach prenatal visits by avoiding triggering language or using inappropriate pronouns. Simply asking a trans patient about preferred pronouns and terminology for body parts can be the difference between a negative and positive pregnancy experience. For example, a transman may prefer a different term for vagina/vulva/cervix. This is especially important at the time of delivery, when exams may become more frequent for the patient. However, inclusive prenatal care starts from the first prenatal visit when the patient checks in and continues all the way through the doctor/patient experience. All office staff should be trained to use preferred names and pronouns and gender-neutral restrooms should be easily accessible. Likewise, waiting rooms should include visible support for the LGBTQ (lesbian, gay, bisexual, transgender and queer or questioning) patient population.
The anatomy ultrasound and “gender reveal” during the pregnancy and at the time of delivery can understandably also be a sensitive subject for a pregnant trans patient. Previous cultural practice has been to describe the gender of the fetus at the anatomy ultrasound, when in fact, gender can only be self-determined by an individual many years after birth. What the anatomy ultrasound does convey is the appearance of external genitalia to help predict the assigned sex. As obstetrician/gynecologists who practice evidence-based medicine, we are encouraged to challenge the cultural norm of announcing the gender of the baby at time of ultrasound and at time of birth. We should focus instead on conveying what objective information we do know. After the infant is born, we know the sex they are assigned based on the what external reproductive organs are seen.
In the postpartum period, trans patients who successfully carried a pregnancy may choose to feed their infant with their own human milk. For some trans patients, breastfeeding may be referred to as chestfeeding, since this terminology is more gender neutral. Having prior chest masculinization surgery does not exclude a transmasculine patient from lactating, although milk production may vary. Patients should be counseled that there is limited data on the safety of testosterone use while lactating.1 We found only one case report of induced lactation in a nonpuerperal transfeminine patient.5 In addition to addressing infant feeding concerns, obstetrician/gynecologists should counsel postpartum trans patients about contraceptive options and screen for perinatal mood disorders, especially those patients with a history of mood disorders before pregnancy.
Ultimately, trans patients seeking fertility options and obstetrical care have a right to obtain reliable information and access gender-inclusive treatment from their obstetrician/gynecologists. Each family makeup is unique and should be respected by all health care professionals taking care of the patient. As obstetrician/gynecologists, it is our duty to coordinate and advocate for the equitable care of our trans patients who want to grow their families.
Dr. Joyner is an assistant professor at Emory University, Atlanta, and is the director of gynecologic services in the Gender Center at Grady Memorial Hospital in Atlanta. Dr. Joyner identifies as a cisgender female and uses she/hers/her as her personal pronouns. Dr. Katie Riddle is an ob.gyn. in Connecticut who is passionate about LGBTQ health care. She recently completed her residency in Ann Arbor, Mich. Dr. Riddle identifies as a cisgender female and uses she/hers/her as her personal pronouns. Dr. Joyner and Dr. Riddle said they had no financial disclosures. Email them at [email protected].
References
1. Viloria RP. “Reproductive Health and Obstetric Care in Transgender Patients.” Fenway Health.
2. Amato P. “Fertility options for transgender persons.” University of California, San Francisco Transgender Care and Treatment Guidelines. 2016 Jun 17.
3. Fertil Steril. 2015 Nov. doi: 10.1016/j.fertnstert.2015.08.021.
4. Obstet Gynecol. 2014. doi: 10.1097/AOG.0000000000000540.
5. Transgend Health. 2018 Jan 1. doi: 10.1089/trgh.2017.0044.
My patient tells me that they are transgender – now what?
I am privileged to work in a university hospital system where I have access to colleagues with expertise in LGBT health; however, medical providers in the community may not enjoy such resources. Many transgender and gender-diverse (TGD) youth now are seeking help from their community primary care providers to affirm their gender identity, but many community primary care providers do not have the luxury of referring these patients to an expert in gender-affirming care when their TGD patients express the desire to affirm their gender through medical and surgical means. This is even more difficult if the nearest referral center is hundreds of miles away. Nevertheless, 
If a TGD youth discloses their gender identity to you, it is critical that you make the patient feel safe and supported. Showing support is important in maintaining rapport between you and the patient. Furthermore, you may be one of the very few adults in the child’s life whom they can trust.
First of all, thank them. For many TGD patients, disclosing their gender identity to a health care provider can be a herculean task. They may have spent many hours trying to find the right words to say to disclose an important aspect of themselves to you. They also probably spent a fair amount of time worrying about whether or not you would react positively to this disclosure. This fear is reasonable. About one-fifth of transgender people have reported being kicked out of a medical practice because of their disclosure of their gender identity.1
Secondly, assure the TGD patient that your treatment would be no different from the care provided for other patients. Discrimination from a health care provider has frequently been reported by TGD patients1 and is expected from this population.2 By emphasizing this, you have signaled to them that you are committed to treating them with dignity and respect. Furthermore, signal your commitment to this treatment by making the clinic a safe and welcoming place for LGBT youth. Several resources exist that can help with this. The American Medical Association provides a good example on how to draft a nondiscrimination statement that can be posted in waiting areas;3 the Fenway Institute has a good example of an intake form that is LGBT friendly.4
In addition, a good way to help affirm their gender identity is to tell them that being transgender or gender-diverse is normal and healthy. Many times, TGD youth will hear narratives that gender diversity is pathological or aberrant; however, hearing that they are healthy and normal, especially from a health care provider, can make a powerful impact on feeling supported and affirmed.
Furthermore, inform your TGD youth of their right to confidentiality. Many TGD youth may not be out to their parents, and you may be the first person to whom they disclosed their gender identity. This is especially helpful if you describe their right to and the limits of confidentiality (e.g., suicidality) at the beginning of the visit. Assurance of confidentiality is a vital reason adolescents and young adults seek health care from a medical provider,5 and the same can be said of TGD youth; however, keep in mind that if they do desire to transition using cross-sex hormones or surgery, parental permission is required.
If they are not out to their parents and they are planning to come out to their parents, offer to be there when they do. Having someone to support the child – someone who is a medical provider – can add to the sense of legitimacy that what the child is experiencing is normal and healthy. Providing guidance on how parents can support their TGD child is essential for successful affirmation, and some suggestions can be found in an LGBT Youth Consult column I wrote titled, “Guidance for parents of LGBT youth.”
If you practice in a location where the nearest expert in gender-affirming care can be hundreds of miles away, educate yourself on gender-affirming care. Several guidelines are available. The World Professional Society for Transgender Standards of Care (SOC) focuses on the mental health aspects of gender-affirming care. The SOC recommends, but no longer requires, letters from a mental health therapist to start gender-affirming medical treatments and does allow for a discussion between you and the patient on the risks, benefits, alternatives, unknowns, limitations of treatment, and risks of not treating (i.e., obtaining informed consent) as the threshold for hormone therapy.6 This approach, known as the “informed consent model,” can be helpful in expanding health care access for TGD youth. Furthermore, there’s the Endocrine Society Clinical Practice Guidelines7 and the University of California, San Francisco, Guidelines,8 which focus on the medical aspects of gender-affirming care, such as when to start pubertal blockers and dosing for cross-sex hormones. Finally, there are resources that allow providers to consult an expert remotely for more complicated cases. Transline is a transgender medical consultation service staffed by medical providers with expertise in gender-affirming care. Providers can learn more about this valuable service on the website: http://project-health.org/transline/.
Working in a major medical center is not necessary in providing gender-affirming care to TGD youth. Being respectful, supportive, and having the willingness to learn are the minimal requirements. Resources are available to help guide you on the more technical aspects of gender-affirming care. Maintaining a supportive environment and using these resources will help you expand health care access for this population.
Dr. Montano is an assistant professor of pediatrics at the University of Pittsburgh and an adolescent medicine physician at Children’s Hospital of Pittsburgh of UPMC. Email him at [email protected].
References
1. Injustice at every turn: A report of the national transgender discrimination survey (National Center for Transgender Equality and National Gay and Lesbian Task Force, 2011).
2. Psychol Bull. 2003 Sep;129(5):674-97.
3. “Creating an LGBTQ-friendly practice,” American Medical Association.
4. Fenway Health Client Registration Form.
5. JAMA. 1993 Mar 17;269(11):1404-7.
6. Int J Transgenderism 2012;13:165-232.
7. J Clin Endocrinol Metab. 2017 Nov 1;102(11):3869-903.
8. “Guidelines for the Primary and Gender-Affirming Care of Transgender and Gender Nonbinary People,” 2nd edition (San Francisco, CA: University of California, San Francisco, June 17, 2016).
I am privileged to work in a university hospital system where I have access to colleagues with expertise in LGBT health; however, medical providers in the community may not enjoy such resources. Many transgender and gender-diverse (TGD) youth now are seeking help from their community primary care providers to affirm their gender identity, but many community primary care providers do not have the luxury of referring these patients to an expert in gender-affirming care when their TGD patients express the desire to affirm their gender through medical and surgical means. This is even more difficult if the nearest referral center is hundreds of miles away. Nevertheless,
If a TGD youth discloses their gender identity to you, it is critical that you make the patient feel safe and supported. Showing support is important in maintaining rapport between you and the patient. Furthermore, you may be one of the very few adults in the child’s life whom they can trust.
First of all, thank them. For many TGD patients, disclosing their gender identity to a health care provider can be a herculean task. They may have spent many hours trying to find the right words to say to disclose an important aspect of themselves to you. They also probably spent a fair amount of time worrying about whether or not you would react positively to this disclosure. This fear is reasonable. About one-fifth of transgender people have reported being kicked out of a medical practice because of their disclosure of their gender identity.1
Secondly, assure the TGD patient that your treatment would be no different from the care provided for other patients. Discrimination from a health care provider has frequently been reported by TGD patients1 and is expected from this population.2 By emphasizing this, you have signaled to them that you are committed to treating them with dignity and respect. Furthermore, signal your commitment to this treatment by making the clinic a safe and welcoming place for LGBT youth. Several resources exist that can help with this. The American Medical Association provides a good example on how to draft a nondiscrimination statement that can be posted in waiting areas;3 the Fenway Institute has a good example of an intake form that is LGBT friendly.4
In addition, a good way to help affirm their gender identity is to tell them that being transgender or gender-diverse is normal and healthy. Many times, TGD youth will hear narratives that gender diversity is pathological or aberrant; however, hearing that they are healthy and normal, especially from a health care provider, can make a powerful impact on feeling supported and affirmed.
Furthermore, inform your TGD youth of their right to confidentiality. Many TGD youth may not be out to their parents, and you may be the first person to whom they disclosed their gender identity. This is especially helpful if you describe their right to and the limits of confidentiality (e.g., suicidality) at the beginning of the visit. Assurance of confidentiality is a vital reason adolescents and young adults seek health care from a medical provider,5 and the same can be said of TGD youth; however, keep in mind that if they do desire to transition using cross-sex hormones or surgery, parental permission is required.
If they are not out to their parents and they are planning to come out to their parents, offer to be there when they do. Having someone to support the child – someone who is a medical provider – can add to the sense of legitimacy that what the child is experiencing is normal and healthy. Providing guidance on how parents can support their TGD child is essential for successful affirmation, and some suggestions can be found in an LGBT Youth Consult column I wrote titled, “Guidance for parents of LGBT youth.”
If you practice in a location where the nearest expert in gender-affirming care can be hundreds of miles away, educate yourself on gender-affirming care. Several guidelines are available. The World Professional Society for Transgender Standards of Care (SOC) focuses on the mental health aspects of gender-affirming care. The SOC recommends, but no longer requires, letters from a mental health therapist to start gender-affirming medical treatments and does allow for a discussion between you and the patient on the risks, benefits, alternatives, unknowns, limitations of treatment, and risks of not treating (i.e., obtaining informed consent) as the threshold for hormone therapy.6 This approach, known as the “informed consent model,” can be helpful in expanding health care access for TGD youth. Furthermore, there’s the Endocrine Society Clinical Practice Guidelines7 and the University of California, San Francisco, Guidelines,8 which focus on the medical aspects of gender-affirming care, such as when to start pubertal blockers and dosing for cross-sex hormones. Finally, there are resources that allow providers to consult an expert remotely for more complicated cases. Transline is a transgender medical consultation service staffed by medical providers with expertise in gender-affirming care. Providers can learn more about this valuable service on the website: http://project-health.org/transline/.
Working in a major medical center is not necessary in providing gender-affirming care to TGD youth. Being respectful, supportive, and having the willingness to learn are the minimal requirements. Resources are available to help guide you on the more technical aspects of gender-affirming care. Maintaining a supportive environment and using these resources will help you expand health care access for this population.
Dr. Montano is an assistant professor of pediatrics at the University of Pittsburgh and an adolescent medicine physician at Children’s Hospital of Pittsburgh of UPMC. Email him at [email protected].
References
1. Injustice at every turn: A report of the national transgender discrimination survey (National Center for Transgender Equality and National Gay and Lesbian Task Force, 2011).
2. Psychol Bull. 2003 Sep;129(5):674-97.
3. “Creating an LGBTQ-friendly practice,” American Medical Association.
4. Fenway Health Client Registration Form.
5. JAMA. 1993 Mar 17;269(11):1404-7.
6. Int J Transgenderism 2012;13:165-232.
7. J Clin Endocrinol Metab. 2017 Nov 1;102(11):3869-903.
8. “Guidelines for the Primary and Gender-Affirming Care of Transgender and Gender Nonbinary People,” 2nd edition (San Francisco, CA: University of California, San Francisco, June 17, 2016).
I am privileged to work in a university hospital system where I have access to colleagues with expertise in LGBT health; however, medical providers in the community may not enjoy such resources. Many transgender and gender-diverse (TGD) youth now are seeking help from their community primary care providers to affirm their gender identity, but many community primary care providers do not have the luxury of referring these patients to an expert in gender-affirming care when their TGD patients express the desire to affirm their gender through medical and surgical means. This is even more difficult if the nearest referral center is hundreds of miles away. Nevertheless,
If a TGD youth discloses their gender identity to you, it is critical that you make the patient feel safe and supported. Showing support is important in maintaining rapport between you and the patient. Furthermore, you may be one of the very few adults in the child’s life whom they can trust.
First of all, thank them. For many TGD patients, disclosing their gender identity to a health care provider can be a herculean task. They may have spent many hours trying to find the right words to say to disclose an important aspect of themselves to you. They also probably spent a fair amount of time worrying about whether or not you would react positively to this disclosure. This fear is reasonable. About one-fifth of transgender people have reported being kicked out of a medical practice because of their disclosure of their gender identity.1
Secondly, assure the TGD patient that your treatment would be no different from the care provided for other patients. Discrimination from a health care provider has frequently been reported by TGD patients1 and is expected from this population.2 By emphasizing this, you have signaled to them that you are committed to treating them with dignity and respect. Furthermore, signal your commitment to this treatment by making the clinic a safe and welcoming place for LGBT youth. Several resources exist that can help with this. The American Medical Association provides a good example on how to draft a nondiscrimination statement that can be posted in waiting areas;3 the Fenway Institute has a good example of an intake form that is LGBT friendly.4
In addition, a good way to help affirm their gender identity is to tell them that being transgender or gender-diverse is normal and healthy. Many times, TGD youth will hear narratives that gender diversity is pathological or aberrant; however, hearing that they are healthy and normal, especially from a health care provider, can make a powerful impact on feeling supported and affirmed.
Furthermore, inform your TGD youth of their right to confidentiality. Many TGD youth may not be out to their parents, and you may be the first person to whom they disclosed their gender identity. This is especially helpful if you describe their right to and the limits of confidentiality (e.g., suicidality) at the beginning of the visit. Assurance of confidentiality is a vital reason adolescents and young adults seek health care from a medical provider,5 and the same can be said of TGD youth; however, keep in mind that if they do desire to transition using cross-sex hormones or surgery, parental permission is required.
If they are not out to their parents and they are planning to come out to their parents, offer to be there when they do. Having someone to support the child – someone who is a medical provider – can add to the sense of legitimacy that what the child is experiencing is normal and healthy. Providing guidance on how parents can support their TGD child is essential for successful affirmation, and some suggestions can be found in an LGBT Youth Consult column I wrote titled, “Guidance for parents of LGBT youth.”
If you practice in a location where the nearest expert in gender-affirming care can be hundreds of miles away, educate yourself on gender-affirming care. Several guidelines are available. The World Professional Society for Transgender Standards of Care (SOC) focuses on the mental health aspects of gender-affirming care. The SOC recommends, but no longer requires, letters from a mental health therapist to start gender-affirming medical treatments and does allow for a discussion between you and the patient on the risks, benefits, alternatives, unknowns, limitations of treatment, and risks of not treating (i.e., obtaining informed consent) as the threshold for hormone therapy.6 This approach, known as the “informed consent model,” can be helpful in expanding health care access for TGD youth. Furthermore, there’s the Endocrine Society Clinical Practice Guidelines7 and the University of California, San Francisco, Guidelines,8 which focus on the medical aspects of gender-affirming care, such as when to start pubertal blockers and dosing for cross-sex hormones. Finally, there are resources that allow providers to consult an expert remotely for more complicated cases. Transline is a transgender medical consultation service staffed by medical providers with expertise in gender-affirming care. Providers can learn more about this valuable service on the website: http://project-health.org/transline/.
Working in a major medical center is not necessary in providing gender-affirming care to TGD youth. Being respectful, supportive, and having the willingness to learn are the minimal requirements. Resources are available to help guide you on the more technical aspects of gender-affirming care. Maintaining a supportive environment and using these resources will help you expand health care access for this population.
Dr. Montano is an assistant professor of pediatrics at the University of Pittsburgh and an adolescent medicine physician at Children’s Hospital of Pittsburgh of UPMC. Email him at [email protected].
References
1. Injustice at every turn: A report of the national transgender discrimination survey (National Center for Transgender Equality and National Gay and Lesbian Task Force, 2011).
2. Psychol Bull. 2003 Sep;129(5):674-97.
3. “Creating an LGBTQ-friendly practice,” American Medical Association.
4. Fenway Health Client Registration Form.
5. JAMA. 1993 Mar 17;269(11):1404-7.
6. Int J Transgenderism 2012;13:165-232.
7. J Clin Endocrinol Metab. 2017 Nov 1;102(11):3869-903.
8. “Guidelines for the Primary and Gender-Affirming Care of Transgender and Gender Nonbinary People,” 2nd edition (San Francisco, CA: University of California, San Francisco, June 17, 2016).
Supporting our gender-diverse patients
CASE Patient has adverse effects from halted estrogen pills
JR twists her hands nervously as you step into the room. “They stopped my hormones,” she sighs as you pull up her lab results.
JR recently had been admitted to an inpatient cardiology unit for several days for a heart failure exacerbation. Her ankles are still swollen beneath her floral print skirt, but she is breathing much easier now. She is back at your primary care office, hoping to get clearance to restart her estrogen pills.
JR reports having mood swings and terrible nightmares while not taking her hormones, which she has been taking for more than 3 years. She hesitates before sharing, “One of the doctors kept asking me questions about my sex life that had nothing to do with my heart condition. I don’t want to go back there.”
Providing compassionate and comprehensive care to gender-nonconforming individuals is challenging for a multitude of reasons, from clinician ignorance to systemic discrimination. About 33% of transgender patients reported being harassed, denied care, or even being assaulted when seeking health care, while 23% reported avoiding going to the doctor altogether when sick or injured out of fear of discrimination.1
Unfortunately, now, further increases to barriers to care may be put in place. In late May of this year, the Department of Health and Human Services (HHS) proposed new regulations that would reverse previous regulations granted through section 1557 of the Affordable Care Act (ACA)—the Health Care Rights Law—which affirmed the rights of gender nonbinary persons to medical care. Among the proposed changes is the elimination of protections against discrimination in health care based on gender identity.2 The proposed regulation changes come on the heels of a federal court case, which seeks to declare that hospital systems may turn away patients based on gender identity.3
Unraveling rights afforded under the ACA
The Health Care Rights Law was passed under the ACA; it prohibits discrimination based on race, color, national origin, sex, age, and disability in health programs and activities receiving federal financial assistance. Multiple lower courts have supported that the rights of transgender individuals is included within these protections against discrimination on the basis of sex.4 These court rulings not only have ensured the ability of gender-diverse individuals to access care but also have enforced insurance coverage of therapies for gender dysphoria. It was only in 2014 that Medicaid began providing coverage for gender-affirming surgeries and eliminating language that such procedures were “experimental” or “cosmetic.” The 2016 passage of the ACA mandated that private insurance companies follow suit. Unfortunately, the recent proposed regulation changes to the Health Care Rights Law may spark a reversal from insurance companies as well. Such a setback would affect gender-diverse individuals’ hormone treatments as well as their ability to access a full spectrum of care within the health care system.
Continue to: ACOG urges nondiscriminatory practices...
ACOG urges nondiscriminatory practices
The proposed regulation changes to the Health Care Rights Law are from the Conscience and Religious Freedom Division of the HHS Office for Civil Rights, which was established in 2018 and has been advocating for the rights of health care providers to refuse to treat patients based on their own religious beliefs.5 We argue, however, that providing care to persons of varying backgrounds is not an assault on our individual liberties but rather a privilege as providers. As obstetrician-gynecologists, it may be easy to only consider cis-gendered women our responsibility. But our field also emphasizes individual empowerment above all else—we fight every day for our patients’ rights to contraception, fertility, pregnancy, parenthood, and sexual freedoms. Let us continue speaking up for the rights of all those who need gynecologic care, regardless of the pronouns they use.
“The American College of Obstetricians and Gynecologists urges health care providers to foster nondiscriminatory practices and policies to increase identification and to facilitate quality health care for transgender individuals, both in assisting with the transition if desired as well as providing long-term preventive health care.”6
We urge you to take action
- Reach out to your local representatives about protecting transgender health access
- Educate yourself on the unique needs of transgender individuals
- Read personal accounts
- Share your personal story
- Find referring providers near your practice
- 2015 US Transgender Survey. December 2016. https://www.transequality.org/sites/default/files/docs/USTS-Full-Report-FINAL.PDF. Accessed August 30, 2019.
- Musumeci M, Kates J, Dawson J, et al. HHS’ proposed changes to non-discrimination regulations under ACA section 1557. July 1, 2019. https://www.kff.org/disparities-policy/issue-brief/hhss-proposed-changes-to-non-discrimination-regulations-under-aca-section-1557/. Accessed August 30, 2019.
- Franciscan Alliance v. Burwell. ACLU website. https://www.aclu.org/cases/franciscan-alliance-v-burwell. Accessed August 30, 2019.
- Pear R. Trump plan would cut back health care protections for transgender people. April 21, 2018. https://www.nytimes.com/2018/04/21/us/politics/trump-transgender-health-care.html. Accessed August 30, 2019.
- U.S. Department of Health and Human Services. HHS announces new conscience and religious freedom division. January 18, 2018. https://www.hhs.gov/about/news/2018/01/18/hhs-ocr-announces-new-conscience-and-religious-freedom-division.html. Accessed August 30, 2019.
- American College of Obstetricians and Gynecologists Committee on Health Care for Underserved Women. Committee Opinion no. 512: health care for transgender individuals. Obstet Gynecol. 2011;118:1454–1458.
CASE Patient has adverse effects from halted estrogen pills
JR twists her hands nervously as you step into the room. “They stopped my hormones,” she sighs as you pull up her lab results.
JR recently had been admitted to an inpatient cardiology unit for several days for a heart failure exacerbation. Her ankles are still swollen beneath her floral print skirt, but she is breathing much easier now. She is back at your primary care office, hoping to get clearance to restart her estrogen pills.
JR reports having mood swings and terrible nightmares while not taking her hormones, which she has been taking for more than 3 years. She hesitates before sharing, “One of the doctors kept asking me questions about my sex life that had nothing to do with my heart condition. I don’t want to go back there.”
Providing compassionate and comprehensive care to gender-nonconforming individuals is challenging for a multitude of reasons, from clinician ignorance to systemic discrimination. About 33% of transgender patients reported being harassed, denied care, or even being assaulted when seeking health care, while 23% reported avoiding going to the doctor altogether when sick or injured out of fear of discrimination.1
Unfortunately, now, further increases to barriers to care may be put in place. In late May of this year, the Department of Health and Human Services (HHS) proposed new regulations that would reverse previous regulations granted through section 1557 of the Affordable Care Act (ACA)—the Health Care Rights Law—which affirmed the rights of gender nonbinary persons to medical care. Among the proposed changes is the elimination of protections against discrimination in health care based on gender identity.2 The proposed regulation changes come on the heels of a federal court case, which seeks to declare that hospital systems may turn away patients based on gender identity.3
Unraveling rights afforded under the ACA
The Health Care Rights Law was passed under the ACA; it prohibits discrimination based on race, color, national origin, sex, age, and disability in health programs and activities receiving federal financial assistance. Multiple lower courts have supported that the rights of transgender individuals is included within these protections against discrimination on the basis of sex.4 These court rulings not only have ensured the ability of gender-diverse individuals to access care but also have enforced insurance coverage of therapies for gender dysphoria. It was only in 2014 that Medicaid began providing coverage for gender-affirming surgeries and eliminating language that such procedures were “experimental” or “cosmetic.” The 2016 passage of the ACA mandated that private insurance companies follow suit. Unfortunately, the recent proposed regulation changes to the Health Care Rights Law may spark a reversal from insurance companies as well. Such a setback would affect gender-diverse individuals’ hormone treatments as well as their ability to access a full spectrum of care within the health care system.
Continue to: ACOG urges nondiscriminatory practices...
ACOG urges nondiscriminatory practices
The proposed regulation changes to the Health Care Rights Law are from the Conscience and Religious Freedom Division of the HHS Office for Civil Rights, which was established in 2018 and has been advocating for the rights of health care providers to refuse to treat patients based on their own religious beliefs.5 We argue, however, that providing care to persons of varying backgrounds is not an assault on our individual liberties but rather a privilege as providers. As obstetrician-gynecologists, it may be easy to only consider cis-gendered women our responsibility. But our field also emphasizes individual empowerment above all else—we fight every day for our patients’ rights to contraception, fertility, pregnancy, parenthood, and sexual freedoms. Let us continue speaking up for the rights of all those who need gynecologic care, regardless of the pronouns they use.
“The American College of Obstetricians and Gynecologists urges health care providers to foster nondiscriminatory practices and policies to increase identification and to facilitate quality health care for transgender individuals, both in assisting with the transition if desired as well as providing long-term preventive health care.”6
We urge you to take action
- Reach out to your local representatives about protecting transgender health access
- Educate yourself on the unique needs of transgender individuals
- Read personal accounts
- Share your personal story
- Find referring providers near your practice
CASE Patient has adverse effects from halted estrogen pills
JR twists her hands nervously as you step into the room. “They stopped my hormones,” she sighs as you pull up her lab results.
JR recently had been admitted to an inpatient cardiology unit for several days for a heart failure exacerbation. Her ankles are still swollen beneath her floral print skirt, but she is breathing much easier now. She is back at your primary care office, hoping to get clearance to restart her estrogen pills.
JR reports having mood swings and terrible nightmares while not taking her hormones, which she has been taking for more than 3 years. She hesitates before sharing, “One of the doctors kept asking me questions about my sex life that had nothing to do with my heart condition. I don’t want to go back there.”
Providing compassionate and comprehensive care to gender-nonconforming individuals is challenging for a multitude of reasons, from clinician ignorance to systemic discrimination. About 33% of transgender patients reported being harassed, denied care, or even being assaulted when seeking health care, while 23% reported avoiding going to the doctor altogether when sick or injured out of fear of discrimination.1
Unfortunately, now, further increases to barriers to care may be put in place. In late May of this year, the Department of Health and Human Services (HHS) proposed new regulations that would reverse previous regulations granted through section 1557 of the Affordable Care Act (ACA)—the Health Care Rights Law—which affirmed the rights of gender nonbinary persons to medical care. Among the proposed changes is the elimination of protections against discrimination in health care based on gender identity.2 The proposed regulation changes come on the heels of a federal court case, which seeks to declare that hospital systems may turn away patients based on gender identity.3
Unraveling rights afforded under the ACA
The Health Care Rights Law was passed under the ACA; it prohibits discrimination based on race, color, national origin, sex, age, and disability in health programs and activities receiving federal financial assistance. Multiple lower courts have supported that the rights of transgender individuals is included within these protections against discrimination on the basis of sex.4 These court rulings not only have ensured the ability of gender-diverse individuals to access care but also have enforced insurance coverage of therapies for gender dysphoria. It was only in 2014 that Medicaid began providing coverage for gender-affirming surgeries and eliminating language that such procedures were “experimental” or “cosmetic.” The 2016 passage of the ACA mandated that private insurance companies follow suit. Unfortunately, the recent proposed regulation changes to the Health Care Rights Law may spark a reversal from insurance companies as well. Such a setback would affect gender-diverse individuals’ hormone treatments as well as their ability to access a full spectrum of care within the health care system.
Continue to: ACOG urges nondiscriminatory practices...
ACOG urges nondiscriminatory practices
The proposed regulation changes to the Health Care Rights Law are from the Conscience and Religious Freedom Division of the HHS Office for Civil Rights, which was established in 2018 and has been advocating for the rights of health care providers to refuse to treat patients based on their own religious beliefs.5 We argue, however, that providing care to persons of varying backgrounds is not an assault on our individual liberties but rather a privilege as providers. As obstetrician-gynecologists, it may be easy to only consider cis-gendered women our responsibility. But our field also emphasizes individual empowerment above all else—we fight every day for our patients’ rights to contraception, fertility, pregnancy, parenthood, and sexual freedoms. Let us continue speaking up for the rights of all those who need gynecologic care, regardless of the pronouns they use.
“The American College of Obstetricians and Gynecologists urges health care providers to foster nondiscriminatory practices and policies to increase identification and to facilitate quality health care for transgender individuals, both in assisting with the transition if desired as well as providing long-term preventive health care.”6
We urge you to take action
- Reach out to your local representatives about protecting transgender health access
- Educate yourself on the unique needs of transgender individuals
- Read personal accounts
- Share your personal story
- Find referring providers near your practice
- 2015 US Transgender Survey. December 2016. https://www.transequality.org/sites/default/files/docs/USTS-Full-Report-FINAL.PDF. Accessed August 30, 2019.
- Musumeci M, Kates J, Dawson J, et al. HHS’ proposed changes to non-discrimination regulations under ACA section 1557. July 1, 2019. https://www.kff.org/disparities-policy/issue-brief/hhss-proposed-changes-to-non-discrimination-regulations-under-aca-section-1557/. Accessed August 30, 2019.
- Franciscan Alliance v. Burwell. ACLU website. https://www.aclu.org/cases/franciscan-alliance-v-burwell. Accessed August 30, 2019.
- Pear R. Trump plan would cut back health care protections for transgender people. April 21, 2018. https://www.nytimes.com/2018/04/21/us/politics/trump-transgender-health-care.html. Accessed August 30, 2019.
- U.S. Department of Health and Human Services. HHS announces new conscience and religious freedom division. January 18, 2018. https://www.hhs.gov/about/news/2018/01/18/hhs-ocr-announces-new-conscience-and-religious-freedom-division.html. Accessed August 30, 2019.
- American College of Obstetricians and Gynecologists Committee on Health Care for Underserved Women. Committee Opinion no. 512: health care for transgender individuals. Obstet Gynecol. 2011;118:1454–1458.
- 2015 US Transgender Survey. December 2016. https://www.transequality.org/sites/default/files/docs/USTS-Full-Report-FINAL.PDF. Accessed August 30, 2019.
- Musumeci M, Kates J, Dawson J, et al. HHS’ proposed changes to non-discrimination regulations under ACA section 1557. July 1, 2019. https://www.kff.org/disparities-policy/issue-brief/hhss-proposed-changes-to-non-discrimination-regulations-under-aca-section-1557/. Accessed August 30, 2019.
- Franciscan Alliance v. Burwell. ACLU website. https://www.aclu.org/cases/franciscan-alliance-v-burwell. Accessed August 30, 2019.
- Pear R. Trump plan would cut back health care protections for transgender people. April 21, 2018. https://www.nytimes.com/2018/04/21/us/politics/trump-transgender-health-care.html. Accessed August 30, 2019.
- U.S. Department of Health and Human Services. HHS announces new conscience and religious freedom division. January 18, 2018. https://www.hhs.gov/about/news/2018/01/18/hhs-ocr-announces-new-conscience-and-religious-freedom-division.html. Accessed August 30, 2019.
- American College of Obstetricians and Gynecologists Committee on Health Care for Underserved Women. Committee Opinion no. 512: health care for transgender individuals. Obstet Gynecol. 2011;118:1454–1458.
FDA panel backs Descovy as HIV PrEP for men and transgender women who have sex with men
The Food and Drug Administration’s Antimicrobial Drugs Advisory Committee backed the fixed dose combination of emtricitabine and tenofovir alafenamide (TAF; Descovy, Gilead) for pre-exposure prophylaxis (PrEP) against HIV for men and transgender women who have sex with men.
In a discussion after a 16-2 vote, committee members cited analysis by the study’s sponsor and the FDA showing efficacy and a generally good safety profile in the DISCOVER trial, the single new clinical trial conducted to support TAF’s use for pre-exposure prophylaxis (PrEP).
However, this trial included no cisgender women; the sponsor asked for approval based primarily on extrapolation from the DISCOVER results and previous results with tenofovir disoproxil fumarate (TDF) in cisgender women. Both formulations of tenofovir are prodrugs and converted to tenofovir diphosphate intracellularly in peripheral blood mononuclear cells, though many aspects of their pharmacokinetics differ.
The committee voted 10-8 against the proposition that these data supported an indication of TAF for PrEP in cisgender women, in a narrowly worded question from the FDA.
Many members who voted on either side of the question had strongly worded reservations about the lack of data for cisgender women. Said committee chair Lindsey R. Baden, MD, director of the infectious disease service at Dana-Farber Cancer Institute, Boston, who voted against the indication for cisgender women, “We’ve failed women. To be at this point and not have the data to guide decision-making is a shame on all of us.”
Ighovwerha Ofotokun, MD, who voted yes, concurred: “I agree it is a terrible failure that the agency, as well as the sponsor, would come to this committee with a lack of data on women.” But for Dr. Ofotokun, a professor of infectious diseases at Emory University, Atlanta, not including cisgender women in the approval was a distasteful proposition. “Creating a two-tier prevention and treatment hierarchy would not be helpful. We should remind ourselves that there are more women living with HIV in the world than there are men, and the risk of new HIV infection is higher among women than among men, if you look at this globally,” he said.
“I find it disrespectful and an issue of research equity. Women deserve the same quality of data about the safety and efficacy of the drugs they are exposed to that men get and that is not the situation we find ourselves in at the moment,” said Dawn K. Smith, MD, MPH, a lead scientist at the Centers for Disease Control and Prevention (CDC), Atlanta, who voted against approval for cisgender women.
Michael Green, MD, MPH, professor of pediatrics, surgery and clinical and translational science at the University of Pittsburgh, echoed the frustration of many committee members when he said, “I voted yes, almost abstained, then almost voted no.” He, along with all who voted yes, emphasized the importance of mandatory postmarketing studies in cisgender women to ensure efficacy data are obtained.
Transgender women made up only about 1% of the DISCOVER population, a fact that also gave many committee members pause.
If TAF is approved, labeling and package materials should be clear that the data support only noninferiority, not superiority, compared with TDF, said several advisory committee members who voted for approval for men and transgender women who have sex with men. “My expectation of this approval is that it should be marketed responsibly from the perspective of not creating these disparities and having Truvada be a drug for poor people and Descovy be a drug for rich people,” said Demetre Dasklalakis, MD, assistant commissioner of the Bureau of HIV/AIDS Prevention and Control at the city of New York’s Department of Health and Hygiene, and of the Icahn School of Medicine at Mount Sinai, N.Y. Truvada is slated to be offered as a generic drug in 2020, according to a Securities and Exchange Commission filing by Gilead Sciences.
The CDC reported earlier in 2019 that rates of new HIV infections have plateaued in recent years. Uptake of PrEP has been particularly low among at-risk members of minority populations, in rural areas, and in the South, according to a CDC report.
The DISCOVER trial is a 96-week ongoing trial to test TAF’s noninferiority to a fixed-drug combination of emcitrabine and tenofovir dimethyl fumarate (TDF; Truvada, Gilead) for PrEP. Both drugs are already approved to treat HIV infection, and TDF is approved for PrEP. Non-inferiority was preestablished at a rate ratio of HIV incidence of 1.62 (TAF:TDF) between the two study arms.
DISCOVER has enrolled 5,387 men and transgender women who have sex with men and are deemed at high risk for HIV, and found an incidence rate ratio of 0.47, with the upper bound of the confidence interval at 1.15. Since this figure was less than the prespecified noninferiority margin, both Gilead presenters and the FDA agreed, TAF’s noninferiority for efficacy was established.
Characteristics were similar between patients in the TAF arm (N = 2,694) and the TDF arm (N = 2,693). About 60% of patients in each arm reported having receptive anal sex with at least two partners in the previous 12 weeks, and recent rectal gonorrhea, syphilis, and chlamydia rates were 9-13% at baseline. Two thirds of participants reported recreational drug use, and about one in four reported binge drinking.
Sexual behavior and sexually transmitted infection rates continued generally unchanged from baseline during the study period.
The median age was 34 years, and most participants (84%) were white. Black participants made up 9% of the study population, and about 25% were of Hispanic or Latin ethnic origin.
Known decreases in bone mineral density occur with TDF; these were not seen with TAF, and bone mineral density increased while on TAF for the DISCOVER population aged 19-25 years.
Renal biomarkers of concern with TDF included two proteins linked with proximal tubule dysfunction, as well as estimated glomerular filtration rate. According to the sponsor’s analysis, eGFR fell by 2.3 mL/min for the TAF group, compared with a 1.8 mL/min rise while on TDF (P less than .001). Changes of similar statistical significance were seen for proximal tubular proteinuria. Also, improvements were seen in renal measures for the subset of patients enrolled who were on TDF PrEP at baseline but switched to TAF, in a prespecified subgroup analysis.
However, patients who were on TDF had a significant decrease in total cholesterol and both low- and high-density lipoprotein cholesterol compared with those on TAF, who had minimal changes or slight increases in lipids (P less than .001 for all). Triglycerides rose for those on TAF and remained unchanged for those on TDF (P = .002).
The PrEP indication sought by Gilead includes adults and adolescents, defined as those who weigh more than 35 kg. A nonvoting question put before the committee asked whether the totality of tenofovir data supported an indication of TAF for cisgender men who have insertive vaginal sex; though this extrapolation didn’t give the committee as much pause as the request for approval in cisgender women, they cited similar concerns and noted that cervicovaginal mucosa are different in many ways from rectal mucosa.
The study included no cisgender women, for a host of reasons cited by the sponsor and the FDA. These included high nonadherence rates among this population, relatively lower HIV infection rates among cisgender women in the United States, and mixed efficacy results in previous tenofovir clinical trials; the latter point made establishing a noninferiority margin problematic, according to the FDA.
For Dr. Baden, “The optics of approval for population A but not for population B are problematic.” Speaking to both the sponsor and the FDA, he said, “Everyone agrees there needs to be actual data. Please do the study as quickly as possible.” What’s needed is the collective will to make it happen, he added: “I don’t accept that it’s too big, too hard, too difficult.”
The FDA usually follows the recommendations of its advisory committees.
This article was updated 8/8/19.
The Food and Drug Administration’s Antimicrobial Drugs Advisory Committee backed the fixed dose combination of emtricitabine and tenofovir alafenamide (TAF; Descovy, Gilead) for pre-exposure prophylaxis (PrEP) against HIV for men and transgender women who have sex with men.
In a discussion after a 16-2 vote, committee members cited analysis by the study’s sponsor and the FDA showing efficacy and a generally good safety profile in the DISCOVER trial, the single new clinical trial conducted to support TAF’s use for pre-exposure prophylaxis (PrEP).
However, this trial included no cisgender women; the sponsor asked for approval based primarily on extrapolation from the DISCOVER results and previous results with tenofovir disoproxil fumarate (TDF) in cisgender women. Both formulations of tenofovir are prodrugs and converted to tenofovir diphosphate intracellularly in peripheral blood mononuclear cells, though many aspects of their pharmacokinetics differ.
The committee voted 10-8 against the proposition that these data supported an indication of TAF for PrEP in cisgender women, in a narrowly worded question from the FDA.
Many members who voted on either side of the question had strongly worded reservations about the lack of data for cisgender women. Said committee chair Lindsey R. Baden, MD, director of the infectious disease service at Dana-Farber Cancer Institute, Boston, who voted against the indication for cisgender women, “We’ve failed women. To be at this point and not have the data to guide decision-making is a shame on all of us.”
Ighovwerha Ofotokun, MD, who voted yes, concurred: “I agree it is a terrible failure that the agency, as well as the sponsor, would come to this committee with a lack of data on women.” But for Dr. Ofotokun, a professor of infectious diseases at Emory University, Atlanta, not including cisgender women in the approval was a distasteful proposition. “Creating a two-tier prevention and treatment hierarchy would not be helpful. We should remind ourselves that there are more women living with HIV in the world than there are men, and the risk of new HIV infection is higher among women than among men, if you look at this globally,” he said.
“I find it disrespectful and an issue of research equity. Women deserve the same quality of data about the safety and efficacy of the drugs they are exposed to that men get and that is not the situation we find ourselves in at the moment,” said Dawn K. Smith, MD, MPH, a lead scientist at the Centers for Disease Control and Prevention (CDC), Atlanta, who voted against approval for cisgender women.
Michael Green, MD, MPH, professor of pediatrics, surgery and clinical and translational science at the University of Pittsburgh, echoed the frustration of many committee members when he said, “I voted yes, almost abstained, then almost voted no.” He, along with all who voted yes, emphasized the importance of mandatory postmarketing studies in cisgender women to ensure efficacy data are obtained.
Transgender women made up only about 1% of the DISCOVER population, a fact that also gave many committee members pause.
If TAF is approved, labeling and package materials should be clear that the data support only noninferiority, not superiority, compared with TDF, said several advisory committee members who voted for approval for men and transgender women who have sex with men. “My expectation of this approval is that it should be marketed responsibly from the perspective of not creating these disparities and having Truvada be a drug for poor people and Descovy be a drug for rich people,” said Demetre Dasklalakis, MD, assistant commissioner of the Bureau of HIV/AIDS Prevention and Control at the city of New York’s Department of Health and Hygiene, and of the Icahn School of Medicine at Mount Sinai, N.Y. Truvada is slated to be offered as a generic drug in 2020, according to a Securities and Exchange Commission filing by Gilead Sciences.
The CDC reported earlier in 2019 that rates of new HIV infections have plateaued in recent years. Uptake of PrEP has been particularly low among at-risk members of minority populations, in rural areas, and in the South, according to a CDC report.
The DISCOVER trial is a 96-week ongoing trial to test TAF’s noninferiority to a fixed-drug combination of emcitrabine and tenofovir dimethyl fumarate (TDF; Truvada, Gilead) for PrEP. Both drugs are already approved to treat HIV infection, and TDF is approved for PrEP. Non-inferiority was preestablished at a rate ratio of HIV incidence of 1.62 (TAF:TDF) between the two study arms.
DISCOVER has enrolled 5,387 men and transgender women who have sex with men and are deemed at high risk for HIV, and found an incidence rate ratio of 0.47, with the upper bound of the confidence interval at 1.15. Since this figure was less than the prespecified noninferiority margin, both Gilead presenters and the FDA agreed, TAF’s noninferiority for efficacy was established.
Characteristics were similar between patients in the TAF arm (N = 2,694) and the TDF arm (N = 2,693). About 60% of patients in each arm reported having receptive anal sex with at least two partners in the previous 12 weeks, and recent rectal gonorrhea, syphilis, and chlamydia rates were 9-13% at baseline. Two thirds of participants reported recreational drug use, and about one in four reported binge drinking.
Sexual behavior and sexually transmitted infection rates continued generally unchanged from baseline during the study period.
The median age was 34 years, and most participants (84%) were white. Black participants made up 9% of the study population, and about 25% were of Hispanic or Latin ethnic origin.
Known decreases in bone mineral density occur with TDF; these were not seen with TAF, and bone mineral density increased while on TAF for the DISCOVER population aged 19-25 years.
Renal biomarkers of concern with TDF included two proteins linked with proximal tubule dysfunction, as well as estimated glomerular filtration rate. According to the sponsor’s analysis, eGFR fell by 2.3 mL/min for the TAF group, compared with a 1.8 mL/min rise while on TDF (P less than .001). Changes of similar statistical significance were seen for proximal tubular proteinuria. Also, improvements were seen in renal measures for the subset of patients enrolled who were on TDF PrEP at baseline but switched to TAF, in a prespecified subgroup analysis.
However, patients who were on TDF had a significant decrease in total cholesterol and both low- and high-density lipoprotein cholesterol compared with those on TAF, who had minimal changes or slight increases in lipids (P less than .001 for all). Triglycerides rose for those on TAF and remained unchanged for those on TDF (P = .002).
The PrEP indication sought by Gilead includes adults and adolescents, defined as those who weigh more than 35 kg. A nonvoting question put before the committee asked whether the totality of tenofovir data supported an indication of TAF for cisgender men who have insertive vaginal sex; though this extrapolation didn’t give the committee as much pause as the request for approval in cisgender women, they cited similar concerns and noted that cervicovaginal mucosa are different in many ways from rectal mucosa.
The study included no cisgender women, for a host of reasons cited by the sponsor and the FDA. These included high nonadherence rates among this population, relatively lower HIV infection rates among cisgender women in the United States, and mixed efficacy results in previous tenofovir clinical trials; the latter point made establishing a noninferiority margin problematic, according to the FDA.
For Dr. Baden, “The optics of approval for population A but not for population B are problematic.” Speaking to both the sponsor and the FDA, he said, “Everyone agrees there needs to be actual data. Please do the study as quickly as possible.” What’s needed is the collective will to make it happen, he added: “I don’t accept that it’s too big, too hard, too difficult.”
The FDA usually follows the recommendations of its advisory committees.
This article was updated 8/8/19.
The Food and Drug Administration’s Antimicrobial Drugs Advisory Committee backed the fixed dose combination of emtricitabine and tenofovir alafenamide (TAF; Descovy, Gilead) for pre-exposure prophylaxis (PrEP) against HIV for men and transgender women who have sex with men.
In a discussion after a 16-2 vote, committee members cited analysis by the study’s sponsor and the FDA showing efficacy and a generally good safety profile in the DISCOVER trial, the single new clinical trial conducted to support TAF’s use for pre-exposure prophylaxis (PrEP).
However, this trial included no cisgender women; the sponsor asked for approval based primarily on extrapolation from the DISCOVER results and previous results with tenofovir disoproxil fumarate (TDF) in cisgender women. Both formulations of tenofovir are prodrugs and converted to tenofovir diphosphate intracellularly in peripheral blood mononuclear cells, though many aspects of their pharmacokinetics differ.
The committee voted 10-8 against the proposition that these data supported an indication of TAF for PrEP in cisgender women, in a narrowly worded question from the FDA.
Many members who voted on either side of the question had strongly worded reservations about the lack of data for cisgender women. Said committee chair Lindsey R. Baden, MD, director of the infectious disease service at Dana-Farber Cancer Institute, Boston, who voted against the indication for cisgender women, “We’ve failed women. To be at this point and not have the data to guide decision-making is a shame on all of us.”
Ighovwerha Ofotokun, MD, who voted yes, concurred: “I agree it is a terrible failure that the agency, as well as the sponsor, would come to this committee with a lack of data on women.” But for Dr. Ofotokun, a professor of infectious diseases at Emory University, Atlanta, not including cisgender women in the approval was a distasteful proposition. “Creating a two-tier prevention and treatment hierarchy would not be helpful. We should remind ourselves that there are more women living with HIV in the world than there are men, and the risk of new HIV infection is higher among women than among men, if you look at this globally,” he said.
“I find it disrespectful and an issue of research equity. Women deserve the same quality of data about the safety and efficacy of the drugs they are exposed to that men get and that is not the situation we find ourselves in at the moment,” said Dawn K. Smith, MD, MPH, a lead scientist at the Centers for Disease Control and Prevention (CDC), Atlanta, who voted against approval for cisgender women.
Michael Green, MD, MPH, professor of pediatrics, surgery and clinical and translational science at the University of Pittsburgh, echoed the frustration of many committee members when he said, “I voted yes, almost abstained, then almost voted no.” He, along with all who voted yes, emphasized the importance of mandatory postmarketing studies in cisgender women to ensure efficacy data are obtained.
Transgender women made up only about 1% of the DISCOVER population, a fact that also gave many committee members pause.
If TAF is approved, labeling and package materials should be clear that the data support only noninferiority, not superiority, compared with TDF, said several advisory committee members who voted for approval for men and transgender women who have sex with men. “My expectation of this approval is that it should be marketed responsibly from the perspective of not creating these disparities and having Truvada be a drug for poor people and Descovy be a drug for rich people,” said Demetre Dasklalakis, MD, assistant commissioner of the Bureau of HIV/AIDS Prevention and Control at the city of New York’s Department of Health and Hygiene, and of the Icahn School of Medicine at Mount Sinai, N.Y. Truvada is slated to be offered as a generic drug in 2020, according to a Securities and Exchange Commission filing by Gilead Sciences.
The CDC reported earlier in 2019 that rates of new HIV infections have plateaued in recent years. Uptake of PrEP has been particularly low among at-risk members of minority populations, in rural areas, and in the South, according to a CDC report.
The DISCOVER trial is a 96-week ongoing trial to test TAF’s noninferiority to a fixed-drug combination of emcitrabine and tenofovir dimethyl fumarate (TDF; Truvada, Gilead) for PrEP. Both drugs are already approved to treat HIV infection, and TDF is approved for PrEP. Non-inferiority was preestablished at a rate ratio of HIV incidence of 1.62 (TAF:TDF) between the two study arms.
DISCOVER has enrolled 5,387 men and transgender women who have sex with men and are deemed at high risk for HIV, and found an incidence rate ratio of 0.47, with the upper bound of the confidence interval at 1.15. Since this figure was less than the prespecified noninferiority margin, both Gilead presenters and the FDA agreed, TAF’s noninferiority for efficacy was established.
Characteristics were similar between patients in the TAF arm (N = 2,694) and the TDF arm (N = 2,693). About 60% of patients in each arm reported having receptive anal sex with at least two partners in the previous 12 weeks, and recent rectal gonorrhea, syphilis, and chlamydia rates were 9-13% at baseline. Two thirds of participants reported recreational drug use, and about one in four reported binge drinking.
Sexual behavior and sexually transmitted infection rates continued generally unchanged from baseline during the study period.
The median age was 34 years, and most participants (84%) were white. Black participants made up 9% of the study population, and about 25% were of Hispanic or Latin ethnic origin.
Known decreases in bone mineral density occur with TDF; these were not seen with TAF, and bone mineral density increased while on TAF for the DISCOVER population aged 19-25 years.
Renal biomarkers of concern with TDF included two proteins linked with proximal tubule dysfunction, as well as estimated glomerular filtration rate. According to the sponsor’s analysis, eGFR fell by 2.3 mL/min for the TAF group, compared with a 1.8 mL/min rise while on TDF (P less than .001). Changes of similar statistical significance were seen for proximal tubular proteinuria. Also, improvements were seen in renal measures for the subset of patients enrolled who were on TDF PrEP at baseline but switched to TAF, in a prespecified subgroup analysis.
However, patients who were on TDF had a significant decrease in total cholesterol and both low- and high-density lipoprotein cholesterol compared with those on TAF, who had minimal changes or slight increases in lipids (P less than .001 for all). Triglycerides rose for those on TAF and remained unchanged for those on TDF (P = .002).
The PrEP indication sought by Gilead includes adults and adolescents, defined as those who weigh more than 35 kg. A nonvoting question put before the committee asked whether the totality of tenofovir data supported an indication of TAF for cisgender men who have insertive vaginal sex; though this extrapolation didn’t give the committee as much pause as the request for approval in cisgender women, they cited similar concerns and noted that cervicovaginal mucosa are different in many ways from rectal mucosa.
The study included no cisgender women, for a host of reasons cited by the sponsor and the FDA. These included high nonadherence rates among this population, relatively lower HIV infection rates among cisgender women in the United States, and mixed efficacy results in previous tenofovir clinical trials; the latter point made establishing a noninferiority margin problematic, according to the FDA.
For Dr. Baden, “The optics of approval for population A but not for population B are problematic.” Speaking to both the sponsor and the FDA, he said, “Everyone agrees there needs to be actual data. Please do the study as quickly as possible.” What’s needed is the collective will to make it happen, he added: “I don’t accept that it’s too big, too hard, too difficult.”
The FDA usually follows the recommendations of its advisory committees.
This article was updated 8/8/19.
FROM AN FDA ADVISORY COMMITTEE MEETING
Semen cryopreservation viable for young transgender patients in small study
as transgender women, according to results of a small retrospective cohort study.
The lack of data on this topic, however, makes it difficult to determine how long an individual must be off gender-affirming therapy before spermatogenesis resumes, if it resumes, and what the long-term effects of gender-affirming therapy are.
“This information is critical to address as part of a multidisciplinary fertility discussion with youth and their guardians so that an informed decision can be made regarding fertility preservation use,” wrote Emily P. Barnard, DO, of UPMC Magee-Womens Hospital in Pittsburgh and her associates.
The researchers retrospectively collected data on transgender patients who sought fertility preservation between 2015 and 2018.
The 11 white transgender women (sex assigned male at birth) who followed up on adolescent medicine or pediatric endocrinology referrals for fertility preservation received their consultations between ages 16 and 24, with 19 years having been the median age at which they occurred. Gender dysphoria onset happened at a median age of 12 for the patients, who were evaluated for it at a median age of 17.
All but one patient submitted at least one semen sample, and eight ultimately cryopreserved their semen.
The eight samples from gender-affirming therapy–naive patients had abnormal morphology, with the median morphology having been 6% versus the normal range of greater than 13.0%. Otherwise, the samples collected were normal, but the authors noted that established semen analysis parameters don’t exist for adolescents and young adults.
All eight patients who had their semen cryopreserved, began gonadotropin-releasing hormone (GnRH) agonist therapy after cryopreservation, and four of those patients concurrently began taking estradiol.
One patient had already been taking intramuscular leuprolide acetate every 6 months and discontinued it to attempt fertility preservation. Spermatogenesis returned after 5 months of azoospermia, albeit with abnormal morphology (9%).
Another patient had been taking spironolactone and estradiol for 26 months before ceasing therapy to attempt fertility preservation. She remained azoospermic 4 months after stopping therapy and then moved forward with an orchiectomy.
“For many transgender patients, the potential need to discontinue GnRH agonist or gender-affirming therapy to allow for resumption of spermatogenesis may be a significant barrier to pursuing fertility preservation because cessation of therapy may result in exacerbation of gender dysphoria and progression of undesired male secondary sex characteristics,” the researchers wrote. “For individuals for whom this risk is not acceptable or if azoospermia is noted on semen analysis, there are several alternate options, including electroejaculation, testicular sperm extraction, and testicular tissue cryopreservation,” they continued. Electroejaculation with a transrectal probe is an option particularly for those who cannot masturbate or feel uncomfortable doing so, the authors explained.
For those who have not previously received gender-affirming therapy, the fertility preservation “process can be completed quickly, with collections occurring every 2 to 3 days to preserve several samples before initiating GnRH agonist or gender-affirming therapy,” they concluded.
SOURCE: Barnard EP et al. Pediatrics. 2019 Aug 5. doi: 10.1542/peds.2018-3943.
The lack of long-term data on various gender-affirming medical interventions, particularly hormone therapies, for transgender adolescents and young adults has led professional medical organizations to recommend patients receive fertility counseling before beginning any such therapies.
Yet few data exist on fertility preservation either. The study by Barnard et al. is the first to examine semen cryopreservation outcomes in adolescents and young adults assigned male at birth and asserting a female gender identity.
“There is often urgency to start medical affirming interventions (MAI) among transgender and gender-diverse adolescents and young adults (TGD-AYA) due to gender dysphoria and related psychological sequelae,” wrote Jason Rafferty, MD, MPH, in an accompanying editorial. “However, starting MAI immediately and delaying fertility services may lead to increased overall morbidity for some patients.”
Although multiple professional organizations recommend fertility counseling before MAI initiation, many transgender patients are not following this advice. Dr. Rafferty noted one study found only 20% of TGD-AYA discussed fertility with their physicians before beginning MAI, and only 13% discussed possible effects of MAI on fertility – yet 60% wanted to learn more.
“Barnard et al. review data suggesting TGD-AYA have low interest in fertility services, but many TGD-AYA questioned whether this may later change,” Dr. Rafferty wrote. “After starting MAIs, TGD-AYA report being more emotionally capable of considering future parenting because of increasing comfort with their bodies and romantic relationships.”
Various barriers also exist for TGD-AYA interested in fertility services, such as cost, lack of insurance coverage, low availability of services, increased dysphoria from the procedures, stereotypes, stigma, and interest in starting MAI as soon as possible.
“Under a reproductive justice framework, autonomy around family planning is a right that should not be limited by structural or systemic barriers,” Dr. Rafferty wrote. “Overall, there is a clinical and ethical imperative to better understand and provide access to fertility services for TGD-AYA.”
Jason Rafferty, MD, MPH, is a pediatrician and child psychiatrist who practices at the gender and sexuality clinic in Riverside and at the Adolescent Healthcare Center at Hasbro Children’s Hospital in Providence, R.I. His comments are summarized from an accompanying editorial (Pediatrics 2019 Aug 5. doi: 10.1542/peds.2019-2000).
The lack of long-term data on various gender-affirming medical interventions, particularly hormone therapies, for transgender adolescents and young adults has led professional medical organizations to recommend patients receive fertility counseling before beginning any such therapies.
Yet few data exist on fertility preservation either. The study by Barnard et al. is the first to examine semen cryopreservation outcomes in adolescents and young adults assigned male at birth and asserting a female gender identity.
“There is often urgency to start medical affirming interventions (MAI) among transgender and gender-diverse adolescents and young adults (TGD-AYA) due to gender dysphoria and related psychological sequelae,” wrote Jason Rafferty, MD, MPH, in an accompanying editorial. “However, starting MAI immediately and delaying fertility services may lead to increased overall morbidity for some patients.”
Although multiple professional organizations recommend fertility counseling before MAI initiation, many transgender patients are not following this advice. Dr. Rafferty noted one study found only 20% of TGD-AYA discussed fertility with their physicians before beginning MAI, and only 13% discussed possible effects of MAI on fertility – yet 60% wanted to learn more.
“Barnard et al. review data suggesting TGD-AYA have low interest in fertility services, but many TGD-AYA questioned whether this may later change,” Dr. Rafferty wrote. “After starting MAIs, TGD-AYA report being more emotionally capable of considering future parenting because of increasing comfort with their bodies and romantic relationships.”
Various barriers also exist for TGD-AYA interested in fertility services, such as cost, lack of insurance coverage, low availability of services, increased dysphoria from the procedures, stereotypes, stigma, and interest in starting MAI as soon as possible.
“Under a reproductive justice framework, autonomy around family planning is a right that should not be limited by structural or systemic barriers,” Dr. Rafferty wrote. “Overall, there is a clinical and ethical imperative to better understand and provide access to fertility services for TGD-AYA.”
Jason Rafferty, MD, MPH, is a pediatrician and child psychiatrist who practices at the gender and sexuality clinic in Riverside and at the Adolescent Healthcare Center at Hasbro Children’s Hospital in Providence, R.I. His comments are summarized from an accompanying editorial (Pediatrics 2019 Aug 5. doi: 10.1542/peds.2019-2000).
The lack of long-term data on various gender-affirming medical interventions, particularly hormone therapies, for transgender adolescents and young adults has led professional medical organizations to recommend patients receive fertility counseling before beginning any such therapies.
Yet few data exist on fertility preservation either. The study by Barnard et al. is the first to examine semen cryopreservation outcomes in adolescents and young adults assigned male at birth and asserting a female gender identity.
“There is often urgency to start medical affirming interventions (MAI) among transgender and gender-diverse adolescents and young adults (TGD-AYA) due to gender dysphoria and related psychological sequelae,” wrote Jason Rafferty, MD, MPH, in an accompanying editorial. “However, starting MAI immediately and delaying fertility services may lead to increased overall morbidity for some patients.”
Although multiple professional organizations recommend fertility counseling before MAI initiation, many transgender patients are not following this advice. Dr. Rafferty noted one study found only 20% of TGD-AYA discussed fertility with their physicians before beginning MAI, and only 13% discussed possible effects of MAI on fertility – yet 60% wanted to learn more.
“Barnard et al. review data suggesting TGD-AYA have low interest in fertility services, but many TGD-AYA questioned whether this may later change,” Dr. Rafferty wrote. “After starting MAIs, TGD-AYA report being more emotionally capable of considering future parenting because of increasing comfort with their bodies and romantic relationships.”
Various barriers also exist for TGD-AYA interested in fertility services, such as cost, lack of insurance coverage, low availability of services, increased dysphoria from the procedures, stereotypes, stigma, and interest in starting MAI as soon as possible.
“Under a reproductive justice framework, autonomy around family planning is a right that should not be limited by structural or systemic barriers,” Dr. Rafferty wrote. “Overall, there is a clinical and ethical imperative to better understand and provide access to fertility services for TGD-AYA.”
Jason Rafferty, MD, MPH, is a pediatrician and child psychiatrist who practices at the gender and sexuality clinic in Riverside and at the Adolescent Healthcare Center at Hasbro Children’s Hospital in Providence, R.I. His comments are summarized from an accompanying editorial (Pediatrics 2019 Aug 5. doi: 10.1542/peds.2019-2000).
as transgender women, according to results of a small retrospective cohort study.
The lack of data on this topic, however, makes it difficult to determine how long an individual must be off gender-affirming therapy before spermatogenesis resumes, if it resumes, and what the long-term effects of gender-affirming therapy are.
“This information is critical to address as part of a multidisciplinary fertility discussion with youth and their guardians so that an informed decision can be made regarding fertility preservation use,” wrote Emily P. Barnard, DO, of UPMC Magee-Womens Hospital in Pittsburgh and her associates.
The researchers retrospectively collected data on transgender patients who sought fertility preservation between 2015 and 2018.
The 11 white transgender women (sex assigned male at birth) who followed up on adolescent medicine or pediatric endocrinology referrals for fertility preservation received their consultations between ages 16 and 24, with 19 years having been the median age at which they occurred. Gender dysphoria onset happened at a median age of 12 for the patients, who were evaluated for it at a median age of 17.
All but one patient submitted at least one semen sample, and eight ultimately cryopreserved their semen.
The eight samples from gender-affirming therapy–naive patients had abnormal morphology, with the median morphology having been 6% versus the normal range of greater than 13.0%. Otherwise, the samples collected were normal, but the authors noted that established semen analysis parameters don’t exist for adolescents and young adults.
All eight patients who had their semen cryopreserved, began gonadotropin-releasing hormone (GnRH) agonist therapy after cryopreservation, and four of those patients concurrently began taking estradiol.
One patient had already been taking intramuscular leuprolide acetate every 6 months and discontinued it to attempt fertility preservation. Spermatogenesis returned after 5 months of azoospermia, albeit with abnormal morphology (9%).
Another patient had been taking spironolactone and estradiol for 26 months before ceasing therapy to attempt fertility preservation. She remained azoospermic 4 months after stopping therapy and then moved forward with an orchiectomy.
“For many transgender patients, the potential need to discontinue GnRH agonist or gender-affirming therapy to allow for resumption of spermatogenesis may be a significant barrier to pursuing fertility preservation because cessation of therapy may result in exacerbation of gender dysphoria and progression of undesired male secondary sex characteristics,” the researchers wrote. “For individuals for whom this risk is not acceptable or if azoospermia is noted on semen analysis, there are several alternate options, including electroejaculation, testicular sperm extraction, and testicular tissue cryopreservation,” they continued. Electroejaculation with a transrectal probe is an option particularly for those who cannot masturbate or feel uncomfortable doing so, the authors explained.
For those who have not previously received gender-affirming therapy, the fertility preservation “process can be completed quickly, with collections occurring every 2 to 3 days to preserve several samples before initiating GnRH agonist or gender-affirming therapy,” they concluded.
SOURCE: Barnard EP et al. Pediatrics. 2019 Aug 5. doi: 10.1542/peds.2018-3943.
as transgender women, according to results of a small retrospective cohort study.
The lack of data on this topic, however, makes it difficult to determine how long an individual must be off gender-affirming therapy before spermatogenesis resumes, if it resumes, and what the long-term effects of gender-affirming therapy are.
“This information is critical to address as part of a multidisciplinary fertility discussion with youth and their guardians so that an informed decision can be made regarding fertility preservation use,” wrote Emily P. Barnard, DO, of UPMC Magee-Womens Hospital in Pittsburgh and her associates.
The researchers retrospectively collected data on transgender patients who sought fertility preservation between 2015 and 2018.
The 11 white transgender women (sex assigned male at birth) who followed up on adolescent medicine or pediatric endocrinology referrals for fertility preservation received their consultations between ages 16 and 24, with 19 years having been the median age at which they occurred. Gender dysphoria onset happened at a median age of 12 for the patients, who were evaluated for it at a median age of 17.
All but one patient submitted at least one semen sample, and eight ultimately cryopreserved their semen.
The eight samples from gender-affirming therapy–naive patients had abnormal morphology, with the median morphology having been 6% versus the normal range of greater than 13.0%. Otherwise, the samples collected were normal, but the authors noted that established semen analysis parameters don’t exist for adolescents and young adults.
All eight patients who had their semen cryopreserved, began gonadotropin-releasing hormone (GnRH) agonist therapy after cryopreservation, and four of those patients concurrently began taking estradiol.
One patient had already been taking intramuscular leuprolide acetate every 6 months and discontinued it to attempt fertility preservation. Spermatogenesis returned after 5 months of azoospermia, albeit with abnormal morphology (9%).
Another patient had been taking spironolactone and estradiol for 26 months before ceasing therapy to attempt fertility preservation. She remained azoospermic 4 months after stopping therapy and then moved forward with an orchiectomy.
“For many transgender patients, the potential need to discontinue GnRH agonist or gender-affirming therapy to allow for resumption of spermatogenesis may be a significant barrier to pursuing fertility preservation because cessation of therapy may result in exacerbation of gender dysphoria and progression of undesired male secondary sex characteristics,” the researchers wrote. “For individuals for whom this risk is not acceptable or if azoospermia is noted on semen analysis, there are several alternate options, including electroejaculation, testicular sperm extraction, and testicular tissue cryopreservation,” they continued. Electroejaculation with a transrectal probe is an option particularly for those who cannot masturbate or feel uncomfortable doing so, the authors explained.
For those who have not previously received gender-affirming therapy, the fertility preservation “process can be completed quickly, with collections occurring every 2 to 3 days to preserve several samples before initiating GnRH agonist or gender-affirming therapy,” they concluded.
SOURCE: Barnard EP et al. Pediatrics. 2019 Aug 5. doi: 10.1542/peds.2018-3943.
FROM PEDIATRICS
Insomnia common among transgender college students
SAN ANTONIO – Compared with their cisgender counterparts, , results from a large national population-based survey showed.
“That was a stronger association than we expected,” one of the study’s researchers, Lisa B. Matlen, MD, said during an interview at the annual meeting of the Associated Professional Sleep Societies.
According to Dr. Matlen, a fellow in the division of sleep medicine at the University of Michigan, Ann Arbor, the transgender population is “extremely understudied” when it comes to research on sleep disturbances. In an effort to examine the prevalence of sleep disturbances and the association between transgender identity and sleep disturbances among transgender college students in the United States, she and her colleagues drew from the 2016 and 2017 American College Health Association National College Health Assessment II, a confidential, voluntary, electronically administered survey of college and university students. In all, 224,233 students were polled, and the researchers analyzed their responses to questions about gender identity, sleep symptoms, and diagnoses.
The mean age of the respondents was 23 years, and most (82%) were undergraduate students. Of the 224,233 students, 3,471 (1.6%) self-identified as transgender. More than half of the transgender population (61.9%) was white, 10.6% were Hispanic/Latino, 10.5% were Asian or Pacific Islander, 6.3% were biracial or multiracial, 4.6% were black, and the rest were from other ethnicities. Compared with cisgender students, transgender students had increased odds of sleep disturbances (odds ratio, 1.6), not feeling well rested on 4 or more days per week (OR, 1.8), going to bed early on 3 or more days per week due to sleepiness (OR, 1.3), and having insomnia 3 or more days per week (OR, 1.7). In addition, transgender students were nearly three times more likely to have an insomnia diagnosis and treatment, compared with their cisgender counterparts (OR, 2.9).
Dr. Matlen acknowledged certain limitations of the study, including the fact that it drew from a population-based sample and that the survey was based on self-reported information. The study’s first author was Ronald R. Gavidia Romero, MD. The researchers reported having no financial disclosures.
SAN ANTONIO – Compared with their cisgender counterparts, , results from a large national population-based survey showed.
“That was a stronger association than we expected,” one of the study’s researchers, Lisa B. Matlen, MD, said during an interview at the annual meeting of the Associated Professional Sleep Societies.
According to Dr. Matlen, a fellow in the division of sleep medicine at the University of Michigan, Ann Arbor, the transgender population is “extremely understudied” when it comes to research on sleep disturbances. In an effort to examine the prevalence of sleep disturbances and the association between transgender identity and sleep disturbances among transgender college students in the United States, she and her colleagues drew from the 2016 and 2017 American College Health Association National College Health Assessment II, a confidential, voluntary, electronically administered survey of college and university students. In all, 224,233 students were polled, and the researchers analyzed their responses to questions about gender identity, sleep symptoms, and diagnoses.
The mean age of the respondents was 23 years, and most (82%) were undergraduate students. Of the 224,233 students, 3,471 (1.6%) self-identified as transgender. More than half of the transgender population (61.9%) was white, 10.6% were Hispanic/Latino, 10.5% were Asian or Pacific Islander, 6.3% were biracial or multiracial, 4.6% were black, and the rest were from other ethnicities. Compared with cisgender students, transgender students had increased odds of sleep disturbances (odds ratio, 1.6), not feeling well rested on 4 or more days per week (OR, 1.8), going to bed early on 3 or more days per week due to sleepiness (OR, 1.3), and having insomnia 3 or more days per week (OR, 1.7). In addition, transgender students were nearly three times more likely to have an insomnia diagnosis and treatment, compared with their cisgender counterparts (OR, 2.9).
Dr. Matlen acknowledged certain limitations of the study, including the fact that it drew from a population-based sample and that the survey was based on self-reported information. The study’s first author was Ronald R. Gavidia Romero, MD. The researchers reported having no financial disclosures.
SAN ANTONIO – Compared with their cisgender counterparts, , results from a large national population-based survey showed.
“That was a stronger association than we expected,” one of the study’s researchers, Lisa B. Matlen, MD, said during an interview at the annual meeting of the Associated Professional Sleep Societies.
According to Dr. Matlen, a fellow in the division of sleep medicine at the University of Michigan, Ann Arbor, the transgender population is “extremely understudied” when it comes to research on sleep disturbances. In an effort to examine the prevalence of sleep disturbances and the association between transgender identity and sleep disturbances among transgender college students in the United States, she and her colleagues drew from the 2016 and 2017 American College Health Association National College Health Assessment II, a confidential, voluntary, electronically administered survey of college and university students. In all, 224,233 students were polled, and the researchers analyzed their responses to questions about gender identity, sleep symptoms, and diagnoses.
The mean age of the respondents was 23 years, and most (82%) were undergraduate students. Of the 224,233 students, 3,471 (1.6%) self-identified as transgender. More than half of the transgender population (61.9%) was white, 10.6% were Hispanic/Latino, 10.5% were Asian or Pacific Islander, 6.3% were biracial or multiracial, 4.6% were black, and the rest were from other ethnicities. Compared with cisgender students, transgender students had increased odds of sleep disturbances (odds ratio, 1.6), not feeling well rested on 4 or more days per week (OR, 1.8), going to bed early on 3 or more days per week due to sleepiness (OR, 1.3), and having insomnia 3 or more days per week (OR, 1.7). In addition, transgender students were nearly three times more likely to have an insomnia diagnosis and treatment, compared with their cisgender counterparts (OR, 2.9).
Dr. Matlen acknowledged certain limitations of the study, including the fact that it drew from a population-based sample and that the survey was based on self-reported information. The study’s first author was Ronald R. Gavidia Romero, MD. The researchers reported having no financial disclosures.
REPORTING FROM SLEEP 2019
Trump administration plans to repeal transgender health care protections
In a proposed rule issued May 24, the U.S. Department of Health & Human Services outlined its plan to repeal an Obama-era policy that banned health care providers from discriminating against transgender patients. As part of the Affordable Care Act, Congress had directed HHS to apply existing civil rights and health care regulations to the health law exchanges, including rules that were consistent with Title IX, the federal law that prohibits discrimination on the basis of sex in federally funded programs. The Obama administration’s interpretation of this directive barred health care providers from denying care to transgender patients based on gender identify, defined as a patient’s “internal sense of being male, female, neither, or a combination of male and female.”
Repealing the transgender protections in the antidiscrimination policy will make the regulation more consistent with Title IX, according to HHS. In addition, revoking other provisions in the Obama-era policy associated with non–English speaking patients will reduce regulatory costs for unnecessary paperwork by $3.2 billion, according to a statement from the HHS.
“When Congress prohibited sex discrimination, it did so according to the plain meaning of the term, and we are making our regulations conform,” said Roger Severino, director of the HHS’s Office for Civil Rights, in the statement. “The American people want vigorous protection of civil rights and faithfulness to the text of the laws passed by their representatives. The proposed rule would accomplish both goals.”
In addressing the reasoning for the proposal, Mr. Severino noted two court decisions that have found the Obama-era policy unlawful. In 2016, the U.S. District Court for the Northern District of Texas temporarily barred the protections from being enacted, ruling that HHS had adopted an erroneous interpretation of “sex” under Title IX, and that the regulation was arbitrary and capricious for failing to incorporate Title IX’s religious and abortion exemptions. The U.S. District Court for the District of North Dakota agreed in a subsequent decision. Since the preliminary bans against the provisions, HHS has not enforced the protections. Removal of the discrimination protections for transgender patients would conform with the courts’ plain understanding of federal sex discrimination laws, according to HHS.
HHS emphasized that the proposed rule is not intended to remove any protections provided by Congress or to restrict states’ ability to enact health care discrimination protections that exceed Title IX requirements. Rather, the proposed rule would ensure that Title IX and corresponding regulations “follow the will of Congress with respect to the states by not expanding Title IX’s definition of ‘sex’ beyond the statutory bounds,” according to the proposed rule.
In addition to removing the transgender protections, the HHS also proposed to eliminate provisions under the Obama-era policy that required health care literature to be translated into 15 languages. The proposed revisions would eliminate $3.2 billion in unneeded paperwork burdens imposed by the translations, according to the agency. Mr. Severino indicated that the money saved could be used to more effectively address individual needs of non–English speakers such as by providing increased access to translators and interpreters.
The American College of Physicians expressed concern about the agency’s move to rewrite the discrimination rule.
“ACP believes that discrimination against patients, including those who identify as lesbian, gay, bisexual, and transgender (LGBT), creates social stigma that has been linked to negative physical and mental health outcomes, including anxiety, suicide, and substance or alcohol abuse,” ACP President Robert McLean, MD, said in a statement. “ACP strongly urges the administration to withdraw their proposal, and instead, make meaningful policy changes that will ensure nondiscrimination in health care against all patients, regardless of their sexual orientation, gender or gender identity, disability, or proficiency in the English language.”
In a proposed rule issued May 24, the U.S. Department of Health & Human Services outlined its plan to repeal an Obama-era policy that banned health care providers from discriminating against transgender patients. As part of the Affordable Care Act, Congress had directed HHS to apply existing civil rights and health care regulations to the health law exchanges, including rules that were consistent with Title IX, the federal law that prohibits discrimination on the basis of sex in federally funded programs. The Obama administration’s interpretation of this directive barred health care providers from denying care to transgender patients based on gender identify, defined as a patient’s “internal sense of being male, female, neither, or a combination of male and female.”
Repealing the transgender protections in the antidiscrimination policy will make the regulation more consistent with Title IX, according to HHS. In addition, revoking other provisions in the Obama-era policy associated with non–English speaking patients will reduce regulatory costs for unnecessary paperwork by $3.2 billion, according to a statement from the HHS.
“When Congress prohibited sex discrimination, it did so according to the plain meaning of the term, and we are making our regulations conform,” said Roger Severino, director of the HHS’s Office for Civil Rights, in the statement. “The American people want vigorous protection of civil rights and faithfulness to the text of the laws passed by their representatives. The proposed rule would accomplish both goals.”
In addressing the reasoning for the proposal, Mr. Severino noted two court decisions that have found the Obama-era policy unlawful. In 2016, the U.S. District Court for the Northern District of Texas temporarily barred the protections from being enacted, ruling that HHS had adopted an erroneous interpretation of “sex” under Title IX, and that the regulation was arbitrary and capricious for failing to incorporate Title IX’s religious and abortion exemptions. The U.S. District Court for the District of North Dakota agreed in a subsequent decision. Since the preliminary bans against the provisions, HHS has not enforced the protections. Removal of the discrimination protections for transgender patients would conform with the courts’ plain understanding of federal sex discrimination laws, according to HHS.
HHS emphasized that the proposed rule is not intended to remove any protections provided by Congress or to restrict states’ ability to enact health care discrimination protections that exceed Title IX requirements. Rather, the proposed rule would ensure that Title IX and corresponding regulations “follow the will of Congress with respect to the states by not expanding Title IX’s definition of ‘sex’ beyond the statutory bounds,” according to the proposed rule.
In addition to removing the transgender protections, the HHS also proposed to eliminate provisions under the Obama-era policy that required health care literature to be translated into 15 languages. The proposed revisions would eliminate $3.2 billion in unneeded paperwork burdens imposed by the translations, according to the agency. Mr. Severino indicated that the money saved could be used to more effectively address individual needs of non–English speakers such as by providing increased access to translators and interpreters.
The American College of Physicians expressed concern about the agency’s move to rewrite the discrimination rule.
“ACP believes that discrimination against patients, including those who identify as lesbian, gay, bisexual, and transgender (LGBT), creates social stigma that has been linked to negative physical and mental health outcomes, including anxiety, suicide, and substance or alcohol abuse,” ACP President Robert McLean, MD, said in a statement. “ACP strongly urges the administration to withdraw their proposal, and instead, make meaningful policy changes that will ensure nondiscrimination in health care against all patients, regardless of their sexual orientation, gender or gender identity, disability, or proficiency in the English language.”
In a proposed rule issued May 24, the U.S. Department of Health & Human Services outlined its plan to repeal an Obama-era policy that banned health care providers from discriminating against transgender patients. As part of the Affordable Care Act, Congress had directed HHS to apply existing civil rights and health care regulations to the health law exchanges, including rules that were consistent with Title IX, the federal law that prohibits discrimination on the basis of sex in federally funded programs. The Obama administration’s interpretation of this directive barred health care providers from denying care to transgender patients based on gender identify, defined as a patient’s “internal sense of being male, female, neither, or a combination of male and female.”
Repealing the transgender protections in the antidiscrimination policy will make the regulation more consistent with Title IX, according to HHS. In addition, revoking other provisions in the Obama-era policy associated with non–English speaking patients will reduce regulatory costs for unnecessary paperwork by $3.2 billion, according to a statement from the HHS.
“When Congress prohibited sex discrimination, it did so according to the plain meaning of the term, and we are making our regulations conform,” said Roger Severino, director of the HHS’s Office for Civil Rights, in the statement. “The American people want vigorous protection of civil rights and faithfulness to the text of the laws passed by their representatives. The proposed rule would accomplish both goals.”
In addressing the reasoning for the proposal, Mr. Severino noted two court decisions that have found the Obama-era policy unlawful. In 2016, the U.S. District Court for the Northern District of Texas temporarily barred the protections from being enacted, ruling that HHS had adopted an erroneous interpretation of “sex” under Title IX, and that the regulation was arbitrary and capricious for failing to incorporate Title IX’s religious and abortion exemptions. The U.S. District Court for the District of North Dakota agreed in a subsequent decision. Since the preliminary bans against the provisions, HHS has not enforced the protections. Removal of the discrimination protections for transgender patients would conform with the courts’ plain understanding of federal sex discrimination laws, according to HHS.
HHS emphasized that the proposed rule is not intended to remove any protections provided by Congress or to restrict states’ ability to enact health care discrimination protections that exceed Title IX requirements. Rather, the proposed rule would ensure that Title IX and corresponding regulations “follow the will of Congress with respect to the states by not expanding Title IX’s definition of ‘sex’ beyond the statutory bounds,” according to the proposed rule.
In addition to removing the transgender protections, the HHS also proposed to eliminate provisions under the Obama-era policy that required health care literature to be translated into 15 languages. The proposed revisions would eliminate $3.2 billion in unneeded paperwork burdens imposed by the translations, according to the agency. Mr. Severino indicated that the money saved could be used to more effectively address individual needs of non–English speakers such as by providing increased access to translators and interpreters.
The American College of Physicians expressed concern about the agency’s move to rewrite the discrimination rule.
“ACP believes that discrimination against patients, including those who identify as lesbian, gay, bisexual, and transgender (LGBT), creates social stigma that has been linked to negative physical and mental health outcomes, including anxiety, suicide, and substance or alcohol abuse,” ACP President Robert McLean, MD, said in a statement. “ACP strongly urges the administration to withdraw their proposal, and instead, make meaningful policy changes that will ensure nondiscrimination in health care against all patients, regardless of their sexual orientation, gender or gender identity, disability, or proficiency in the English language.”
Addressing the sexual and reproductive health needs of trans and gender nonconforming patients
Separating gender identity from sexual identity to allow for more comprehensive history-taking
Grouping the term “transgender” in the abbreviation LGBT (lesbian, gay, bisexual, transgender) has historically been empowering for trans and gender nonconforming (GNC) persons. However, it also has contributed to the misunderstanding that gender identity is interchangeable with sexual identity. This common misconception can be a barrier to trans and GNC patients seeking care from ob.gyns. for their reproductive health needs.
By definition, gender identity refers to an internal experience of one’s gender, of one’s self.1 While gender identity has social implications, it ultimately is something that a person experiences independently of interactions with others. By contrast, sexual orientation has an explicitly relational underpinning because sexual orientation involves attraction to others. The distinction between gender identity and sexual orientation is similar to an internal-versus-external, or a self-versus-other dichotomy. A further nuance to add is that sexual behavior does not always reflect sexual orientation, and sexual behavior can vary along a wide spectrum when gender identity is added to the equation.
Overall, When approaching a sexual history with any patient, but especially a transgender or GNC patient, providers should think deeply about what information is medically relevant.2 The purpose of a sexual history is to identify behaviors that contribute to health risk, including pregnancy, sexually transmitted infection, and social problems such as sex-trafficking or intimate partner violence. The health care provider’s job is to ask questions that will uncover these risk factors.
With the advent of a more inclusive attitude toward gay and lesbian partnership, many providers already have learned to collect the sexual history without assuming the gender of a person’s sexual contacts. Still, when a provider is taking the sexual history, gender often is inappropriately used as proxy for the type of sex that a patient may be having. For example, a provider asking a cisgender woman about her sexual activity may ask, “how many sexual partners have you had in the last year?” But then, the provider may follow-up her response of “three sexual partners in the last year” by asking “men, women, or both?” By asking a patient if the patient’s sexual partners are “men, women, or both,” providers fail to accurately elucidate the risk factors that they are actually seeking when taking a sexual history. The cisgender woman from the above scenario may reply that she has been sleeping only with women for the last year, but if the sexual partners are transgender women, aka a woman who was assigned male at birth and therefore still may use her penis/testes for sexual purposes, then the patient actually may be at risk for pregnancy and may also have a different risk factor profile for sexually transmitted infections than if the patient were sexually active with cisgender women.
A different approach to using gender in taking the sexual history is to speak plainly about which sex organs come into contact during sexual activity. When patients identify as transgender or GNC, a provider first should start by asking them what language they would like providers to use when discussing sex organs.3 One example is that many trans men, both those who have undergone mastectomy as well as those who have not, may not use the word “breasts” to describe their “chests.” This distinction may make the difference between gaining and losing the trust of a trans/GNC patient in your clinic. After identifying how a patient would like to refer to sex organs, a provider can continue by asking which of the patient’s sex partners’ organs come into contact with the patient’s organs during sexual activity. Alternatively, starting with an even more broad line of questioning may be best for some patients, such as “how do you like to have sex?”
Carefully identifying the type of sex and what sex organs are involved has concrete medical implications. Patients assigned female at birth who are on hormone therapy with testosterone may need supportive care if they continue to use their vaginas in sexual encounters because testosterone can lead to a relatively hypoestrogenic state. Patients assigned male at birth who have undergone vaginoplasty procedures may need counseling about how to use and support their neovaginas as well as adjusted testing for dysplasia. Patients assigned female at birth who want to avoid pregnancy may need a nuanced consultation regarding contraception. These are just a few examples of how obstetrician-gynecologists can better support the sexual health of their trans/GNC patients by having an accurate understanding of how a trans/GNC person has sex.
Dr. Joyner is an assistant professor at Emory University, Atlanta, and is the director of gynecologic services in the Gender Center at Grady Memorial Hospital in Atlanta. Dr. Joyner identifies as a cisgender female and uses she/hers/her as her personal pronouns. Dr. Joey Bahng is a PGY-1 resident physician in Emory University’s gynecology & obstetrics residency program. Dr. Bahng identifies as nonbinary and uses they/them/their as their personal pronouns. Dr. Bahng and Dr. Joyner reported no relevant financial disclosures
References
1. Sexual orientation and gender identity definitions. Human Rights Campaign.
2. Taking a sexual history from transgender people. Transforming Health at the Centers for Disease Control and Prevention.
3. Sexual health history: Talking sex with gender non-conforming and trans patients. National LGBT Health Education Center at The Fenway Institute.
Separating gender identity from sexual identity to allow for more comprehensive history-taking
Separating gender identity from sexual identity to allow for more comprehensive history-taking
Grouping the term “transgender” in the abbreviation LGBT (lesbian, gay, bisexual, transgender) has historically been empowering for trans and gender nonconforming (GNC) persons. However, it also has contributed to the misunderstanding that gender identity is interchangeable with sexual identity. This common misconception can be a barrier to trans and GNC patients seeking care from ob.gyns. for their reproductive health needs.
By definition, gender identity refers to an internal experience of one’s gender, of one’s self.1 While gender identity has social implications, it ultimately is something that a person experiences independently of interactions with others. By contrast, sexual orientation has an explicitly relational underpinning because sexual orientation involves attraction to others. The distinction between gender identity and sexual orientation is similar to an internal-versus-external, or a self-versus-other dichotomy. A further nuance to add is that sexual behavior does not always reflect sexual orientation, and sexual behavior can vary along a wide spectrum when gender identity is added to the equation.
Overall, When approaching a sexual history with any patient, but especially a transgender or GNC patient, providers should think deeply about what information is medically relevant.2 The purpose of a sexual history is to identify behaviors that contribute to health risk, including pregnancy, sexually transmitted infection, and social problems such as sex-trafficking or intimate partner violence. The health care provider’s job is to ask questions that will uncover these risk factors.
With the advent of a more inclusive attitude toward gay and lesbian partnership, many providers already have learned to collect the sexual history without assuming the gender of a person’s sexual contacts. Still, when a provider is taking the sexual history, gender often is inappropriately used as proxy for the type of sex that a patient may be having. For example, a provider asking a cisgender woman about her sexual activity may ask, “how many sexual partners have you had in the last year?” But then, the provider may follow-up her response of “three sexual partners in the last year” by asking “men, women, or both?” By asking a patient if the patient’s sexual partners are “men, women, or both,” providers fail to accurately elucidate the risk factors that they are actually seeking when taking a sexual history. The cisgender woman from the above scenario may reply that she has been sleeping only with women for the last year, but if the sexual partners are transgender women, aka a woman who was assigned male at birth and therefore still may use her penis/testes for sexual purposes, then the patient actually may be at risk for pregnancy and may also have a different risk factor profile for sexually transmitted infections than if the patient were sexually active with cisgender women.
A different approach to using gender in taking the sexual history is to speak plainly about which sex organs come into contact during sexual activity. When patients identify as transgender or GNC, a provider first should start by asking them what language they would like providers to use when discussing sex organs.3 One example is that many trans men, both those who have undergone mastectomy as well as those who have not, may not use the word “breasts” to describe their “chests.” This distinction may make the difference between gaining and losing the trust of a trans/GNC patient in your clinic. After identifying how a patient would like to refer to sex organs, a provider can continue by asking which of the patient’s sex partners’ organs come into contact with the patient’s organs during sexual activity. Alternatively, starting with an even more broad line of questioning may be best for some patients, such as “how do you like to have sex?”
Carefully identifying the type of sex and what sex organs are involved has concrete medical implications. Patients assigned female at birth who are on hormone therapy with testosterone may need supportive care if they continue to use their vaginas in sexual encounters because testosterone can lead to a relatively hypoestrogenic state. Patients assigned male at birth who have undergone vaginoplasty procedures may need counseling about how to use and support their neovaginas as well as adjusted testing for dysplasia. Patients assigned female at birth who want to avoid pregnancy may need a nuanced consultation regarding contraception. These are just a few examples of how obstetrician-gynecologists can better support the sexual health of their trans/GNC patients by having an accurate understanding of how a trans/GNC person has sex.
Dr. Joyner is an assistant professor at Emory University, Atlanta, and is the director of gynecologic services in the Gender Center at Grady Memorial Hospital in Atlanta. Dr. Joyner identifies as a cisgender female and uses she/hers/her as her personal pronouns. Dr. Joey Bahng is a PGY-1 resident physician in Emory University’s gynecology & obstetrics residency program. Dr. Bahng identifies as nonbinary and uses they/them/their as their personal pronouns. Dr. Bahng and Dr. Joyner reported no relevant financial disclosures
References
1. Sexual orientation and gender identity definitions. Human Rights Campaign.
2. Taking a sexual history from transgender people. Transforming Health at the Centers for Disease Control and Prevention.
3. Sexual health history: Talking sex with gender non-conforming and trans patients. National LGBT Health Education Center at The Fenway Institute.
Grouping the term “transgender” in the abbreviation LGBT (lesbian, gay, bisexual, transgender) has historically been empowering for trans and gender nonconforming (GNC) persons. However, it also has contributed to the misunderstanding that gender identity is interchangeable with sexual identity. This common misconception can be a barrier to trans and GNC patients seeking care from ob.gyns. for their reproductive health needs.
By definition, gender identity refers to an internal experience of one’s gender, of one’s self.1 While gender identity has social implications, it ultimately is something that a person experiences independently of interactions with others. By contrast, sexual orientation has an explicitly relational underpinning because sexual orientation involves attraction to others. The distinction between gender identity and sexual orientation is similar to an internal-versus-external, or a self-versus-other dichotomy. A further nuance to add is that sexual behavior does not always reflect sexual orientation, and sexual behavior can vary along a wide spectrum when gender identity is added to the equation.
Overall, When approaching a sexual history with any patient, but especially a transgender or GNC patient, providers should think deeply about what information is medically relevant.2 The purpose of a sexual history is to identify behaviors that contribute to health risk, including pregnancy, sexually transmitted infection, and social problems such as sex-trafficking or intimate partner violence. The health care provider’s job is to ask questions that will uncover these risk factors.
With the advent of a more inclusive attitude toward gay and lesbian partnership, many providers already have learned to collect the sexual history without assuming the gender of a person’s sexual contacts. Still, when a provider is taking the sexual history, gender often is inappropriately used as proxy for the type of sex that a patient may be having. For example, a provider asking a cisgender woman about her sexual activity may ask, “how many sexual partners have you had in the last year?” But then, the provider may follow-up her response of “three sexual partners in the last year” by asking “men, women, or both?” By asking a patient if the patient’s sexual partners are “men, women, or both,” providers fail to accurately elucidate the risk factors that they are actually seeking when taking a sexual history. The cisgender woman from the above scenario may reply that she has been sleeping only with women for the last year, but if the sexual partners are transgender women, aka a woman who was assigned male at birth and therefore still may use her penis/testes for sexual purposes, then the patient actually may be at risk for pregnancy and may also have a different risk factor profile for sexually transmitted infections than if the patient were sexually active with cisgender women.
A different approach to using gender in taking the sexual history is to speak plainly about which sex organs come into contact during sexual activity. When patients identify as transgender or GNC, a provider first should start by asking them what language they would like providers to use when discussing sex organs.3 One example is that many trans men, both those who have undergone mastectomy as well as those who have not, may not use the word “breasts” to describe their “chests.” This distinction may make the difference between gaining and losing the trust of a trans/GNC patient in your clinic. After identifying how a patient would like to refer to sex organs, a provider can continue by asking which of the patient’s sex partners’ organs come into contact with the patient’s organs during sexual activity. Alternatively, starting with an even more broad line of questioning may be best for some patients, such as “how do you like to have sex?”
Carefully identifying the type of sex and what sex organs are involved has concrete medical implications. Patients assigned female at birth who are on hormone therapy with testosterone may need supportive care if they continue to use their vaginas in sexual encounters because testosterone can lead to a relatively hypoestrogenic state. Patients assigned male at birth who have undergone vaginoplasty procedures may need counseling about how to use and support their neovaginas as well as adjusted testing for dysplasia. Patients assigned female at birth who want to avoid pregnancy may need a nuanced consultation regarding contraception. These are just a few examples of how obstetrician-gynecologists can better support the sexual health of their trans/GNC patients by having an accurate understanding of how a trans/GNC person has sex.
Dr. Joyner is an assistant professor at Emory University, Atlanta, and is the director of gynecologic services in the Gender Center at Grady Memorial Hospital in Atlanta. Dr. Joyner identifies as a cisgender female and uses she/hers/her as her personal pronouns. Dr. Joey Bahng is a PGY-1 resident physician in Emory University’s gynecology & obstetrics residency program. Dr. Bahng identifies as nonbinary and uses they/them/their as their personal pronouns. Dr. Bahng and Dr. Joyner reported no relevant financial disclosures
References
1. Sexual orientation and gender identity definitions. Human Rights Campaign.
2. Taking a sexual history from transgender people. Transforming Health at the Centers for Disease Control and Prevention.
3. Sexual health history: Talking sex with gender non-conforming and trans patients. National LGBT Health Education Center at The Fenway Institute.
Hormone use linked to hair loss in transgender adults
Gender-affirming hormone use was significantly associated with reports of androgenetic alopecia in transgender men, based on data from a survey of 991 individuals.
Given the importance of hair in body image and gender identity, hair concerns are important to the quality of life of gender-minority individuals, wrote Dustin Marks, of Massachusetts General Hospital, Boston, and colleagues.
To explore the impact of hormone use on hair loss in gender-minority patients, the researchers conducted a web-based survey of transgender individuals aged 18 years and older, who self-identified as gender minority. Participants were invited based on profiles on Facebook, YouTube, and Instagram. The findings were published in a research letter in the British Journal of Dermatology.
The 991 survey respondents included 59% transmen, 31% transwomen, and 9% gender nonbinary or gender queer. The average age of the participants was 33 years; 79% were white, 89% had medical insurance, and 91% reported using gender-affirming hormones.
Overall, 65% of transwomen, 43% of transmen, and 35% of nonbinary individuals reported scalp hair loss or thinning. Scalp hair loss was significantly more common among transmen on masculinizing hormones compared to transmen not on hormones (45% vs. 17%). Scalp hair loss was not significantly different between transwomen on feminizing hormones and those not on hormones.
The transwomen who reported scalp hair loss and were on hormones reported significantly less severe Sinclair grades, compared with transwomen with scalp hair loss and were not on hormones. By contrast, transmen and nonbinary individuals on testosterone reported significantly more hair loss (using Hamilton-Norwood and Sinclair scores) between a baseline before hormone use and their present state of hormone use.
The findings support the impact of testosterone use on androgenic alopecia (AGA) in gender-minority patients similar to the established role of testosterone in male pattern hair loss overall, the researchers wrote.
“Some transmen, moreover, may view AGA as a wanted masculine trait, while others seek dermatologic evaluation and treatment for their hair loss,” they noted. By contrast, some transwomen may find AGA especially distressing. In this study, AGA scores were stable for transwomen, which suggests that feminizing hormones may be enough to stabilize hair loss in these patients.
The study was limited by several factors including use of a convenience sample study population without cisgender controls, lack of data on the duration of hormone use, and specific focus on AGE, the researchers noted.
“Mindful of these limitations, clinicians should appreciate the impact of gender-affirming hormones on androgenetic alopecia severity and continue to address the hair concerns of each patient individually,” they wrote.
The researchers had no financial conflicts to disclose, and no sources of study funding were reported.
SOURCE: Marks D et al. Br J Dermatol. 2019 May 3. doi: 10.1111/bjd.18099.
Gender-affirming hormone use was significantly associated with reports of androgenetic alopecia in transgender men, based on data from a survey of 991 individuals.
Given the importance of hair in body image and gender identity, hair concerns are important to the quality of life of gender-minority individuals, wrote Dustin Marks, of Massachusetts General Hospital, Boston, and colleagues.
To explore the impact of hormone use on hair loss in gender-minority patients, the researchers conducted a web-based survey of transgender individuals aged 18 years and older, who self-identified as gender minority. Participants were invited based on profiles on Facebook, YouTube, and Instagram. The findings were published in a research letter in the British Journal of Dermatology.
The 991 survey respondents included 59% transmen, 31% transwomen, and 9% gender nonbinary or gender queer. The average age of the participants was 33 years; 79% were white, 89% had medical insurance, and 91% reported using gender-affirming hormones.
Overall, 65% of transwomen, 43% of transmen, and 35% of nonbinary individuals reported scalp hair loss or thinning. Scalp hair loss was significantly more common among transmen on masculinizing hormones compared to transmen not on hormones (45% vs. 17%). Scalp hair loss was not significantly different between transwomen on feminizing hormones and those not on hormones.
The transwomen who reported scalp hair loss and were on hormones reported significantly less severe Sinclair grades, compared with transwomen with scalp hair loss and were not on hormones. By contrast, transmen and nonbinary individuals on testosterone reported significantly more hair loss (using Hamilton-Norwood and Sinclair scores) between a baseline before hormone use and their present state of hormone use.
The findings support the impact of testosterone use on androgenic alopecia (AGA) in gender-minority patients similar to the established role of testosterone in male pattern hair loss overall, the researchers wrote.
“Some transmen, moreover, may view AGA as a wanted masculine trait, while others seek dermatologic evaluation and treatment for their hair loss,” they noted. By contrast, some transwomen may find AGA especially distressing. In this study, AGA scores were stable for transwomen, which suggests that feminizing hormones may be enough to stabilize hair loss in these patients.
The study was limited by several factors including use of a convenience sample study population without cisgender controls, lack of data on the duration of hormone use, and specific focus on AGE, the researchers noted.
“Mindful of these limitations, clinicians should appreciate the impact of gender-affirming hormones on androgenetic alopecia severity and continue to address the hair concerns of each patient individually,” they wrote.
The researchers had no financial conflicts to disclose, and no sources of study funding were reported.
SOURCE: Marks D et al. Br J Dermatol. 2019 May 3. doi: 10.1111/bjd.18099.
Gender-affirming hormone use was significantly associated with reports of androgenetic alopecia in transgender men, based on data from a survey of 991 individuals.
Given the importance of hair in body image and gender identity, hair concerns are important to the quality of life of gender-minority individuals, wrote Dustin Marks, of Massachusetts General Hospital, Boston, and colleagues.
To explore the impact of hormone use on hair loss in gender-minority patients, the researchers conducted a web-based survey of transgender individuals aged 18 years and older, who self-identified as gender minority. Participants were invited based on profiles on Facebook, YouTube, and Instagram. The findings were published in a research letter in the British Journal of Dermatology.
The 991 survey respondents included 59% transmen, 31% transwomen, and 9% gender nonbinary or gender queer. The average age of the participants was 33 years; 79% were white, 89% had medical insurance, and 91% reported using gender-affirming hormones.
Overall, 65% of transwomen, 43% of transmen, and 35% of nonbinary individuals reported scalp hair loss or thinning. Scalp hair loss was significantly more common among transmen on masculinizing hormones compared to transmen not on hormones (45% vs. 17%). Scalp hair loss was not significantly different between transwomen on feminizing hormones and those not on hormones.
The transwomen who reported scalp hair loss and were on hormones reported significantly less severe Sinclair grades, compared with transwomen with scalp hair loss and were not on hormones. By contrast, transmen and nonbinary individuals on testosterone reported significantly more hair loss (using Hamilton-Norwood and Sinclair scores) between a baseline before hormone use and their present state of hormone use.
The findings support the impact of testosterone use on androgenic alopecia (AGA) in gender-minority patients similar to the established role of testosterone in male pattern hair loss overall, the researchers wrote.
“Some transmen, moreover, may view AGA as a wanted masculine trait, while others seek dermatologic evaluation and treatment for their hair loss,” they noted. By contrast, some transwomen may find AGA especially distressing. In this study, AGA scores were stable for transwomen, which suggests that feminizing hormones may be enough to stabilize hair loss in these patients.
The study was limited by several factors including use of a convenience sample study population without cisgender controls, lack of data on the duration of hormone use, and specific focus on AGE, the researchers noted.
“Mindful of these limitations, clinicians should appreciate the impact of gender-affirming hormones on androgenetic alopecia severity and continue to address the hair concerns of each patient individually,” they wrote.
The researchers had no financial conflicts to disclose, and no sources of study funding were reported.
SOURCE: Marks D et al. Br J Dermatol. 2019 May 3. doi: 10.1111/bjd.18099.
FROM THE BRITISH JOURNAL OF DERMATOLOGY
Key clinical point: Use of hormone therapy had a significant impact on scalp and hair loss in trans men who used masculinizing hormones.
Major finding: Scalp hair loss or hair thinning was reported by 65% of trans women, 43% of trans men, and 35% of nonbinary individuals.
Study details: The data come from a cross-sectional study including 991 adults self-identifying as gender minorities.
Disclosures: The researchers had no financial conflicts to disclose, and no sources of study funding were reported.
Source: Marks D et al. Br J Dermatol. 2019 May 3. doi: 10.1111/bjd.18099.