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Doctors have failed them, say those with transgender regret
In a unique Zoom conference,
The forum was convened on what was dubbed #DetransitionAwarenessDay by Genspect, a parent-based organization that seeks to put the brakes on medical transitions for children and adolescents. The group has doubts about the gender-affirming care model supported by the World Professional Association for Transgender Health, the American Medical Association, the American Academy of Pediatrics, and other medical groups.
“Affirmative” medical care is defined as treatment with puberty blockers and cross-sex hormones for those with gender dysphoria to transition to the opposite sex and is often followed by gender reassignment surgery. However, there is growing concern among many doctors and other health care professionals as to whether this is, in fact, the best way to proceed for those under aged 18, in particular, with several countries pulling back on medical treatment and instead emphasizing psychotherapy first.
The purpose of the second annual Genspect meeting was to shed light on the experiences of individuals who have detransitioned – those that identified as transgender and transitioned, but then decided to end their medical transition. People logged on from all over the United States, Canada, New Zealand, Australia, the United Kingdom, Germany, Spain, Chile, and Brazil, among other countries.
“This is a minority within a minority,” said Genspect advisor Stella O’Malley, adding that the first meeting in 2021 was held because “too many people were dismissing the stories of the detransitioners.” Ms. O’Malley is a psychotherapist, a clinical advisor to the Society for Evidence-Based Gender Medicine, and a founding member of the International Association of Therapists for Desisters and Detransitioners.
“It’s become blindingly obvious over the last year that ... ‘detrans’ is a huge part of the trans phenomenon,” said Ms. O’Malley, adding that detransitioners have been “undermined and dismissed.”
Laura Edwards-Leeper, PhD (@DrLauraEL), a prominent gender therapist who has recently expressed concern regarding adequate gatekeeping when treating youth with gender dysphoria, agreed.
She tweeted: “You simply can’t call yourself a legit gender provider if you don’t believe that detransitioners exist. As part of the informed consent process for transitioning, it is unethical to not discuss this possibility with young people.” Dr. Edwards-Leeper is professor emeritus at Pacific University in Hillsboro, Ore.
Speakers in the forum largely offered experiences, not data. They pointed out that there has been little to no study of detransition, but all testified that it was less rare than it has been portrayed by the transgender community.
Struggles with going back
“There are so many reasons why people detransition,” said Sinead Watson, aged 30, a Genspect advisor who transitioned from female to male, starting in 2015, and who decided to detransition in 2019. Citing a study by Lisa Littman, MD, MPH, published in 2021, Ms. Watson said the most common reasons for detransitioning were realizing that gender dysphoria was caused by other issues; internal homophobia; and the unbearable nature of transphobia.
Ms. Watson said the hardest part of detransitioning was admitting to herself that her transition had been a mistake. “It’s embarrassing and you feel ashamed and guilty,” she said, adding that it may mean losing friends who now regard you as a “bigot, while you’re also dealing with transition regret.”
“It’s a living hell, especially when none of your therapists or counselors will listen to you,” she said. “Detransitioning isn’t fun.”
Carol (@sourpatches2077) said she knew for a year that her transition had been a mistake.
“The biggest part was I couldn’t tell my family,” said Carol, who identifies as a lesbian. “I put them through so much. It seems ridiculous to go: ‘Oops, I made this huge [expletive] mistake,’ ” she said, describing the moment she did tell them as “devastating.”
Grace (@hormonehangover) said she remembers finally hitting a moment of “undeniability” some years after transitioning. “I accept it, I’ve ruined my life, this is wrong,” she remembers thinking. “It was devastating, but I couldn’t deny it anymore.”
Don’t trust therapists
People experiencing feelings of unease “need a therapist who will listen to them,” said Ms. Watson. When she first detransitioned, her therapists treated her badly. “They just didn’t want to speak about detransition,” she said, adding that “it was like a kick in the stomach.”
Ms. Watson said she’d like to see more training about detransition, but also on “preventative techniques,” adding that many people transition who should not. “I don’t want more detransitioners – I want less.
“In order for that to happen, we need to treat people with gender dysphoria properly,” said Ms. Watson, adding that the affirmative model is “disgusting, and that’s what needs to change.”
“I would tell somebody to not go to a therapist,” said Carol. Identifying as a butch lesbian, she felt like her therapists had pushed her into transitioning to male. “The No. 1 thing not understood by the mental health professionals is that the vast majority of homosexuals were gender-nonconforming children.” She added that this is especially true of butch lesbians.
Therapists – and doctors – also need to acknowledge both the trauma of transition and detransition, she said.
Kaiser, where she had transitioned, offered her breast reconstruction. Carol said it felt demeaning. “Like you’re Mr. Potatohead: ‘Here, we can just ... put on some new parts and you’re good to go.’ ”
“Doctors are concretizing transient obsessions,” said Helena Kerschner (@lacroicsz), quoting a chatroom user.
Ms. Kerschner gave a presentation on “fandom”: becoming obsessed with a movie, book, TV show, musician, or celebrity, spending every waking hour chatting online or writing fan fiction, or attempting to interact with the celebrity online. It’s a fantasy-dominated world and “the vast majority” of participants are teenage girls who are “identifying as trans,” in part, because they are fed a community-reinforced message that it’s better to be a boy.
Therapists and physicians who help them transition “are harming them for life based on something they would have grown out of or overcome without the permanent damage,” Ms. Kerschner added.
Doctors ‘gaslighting’ people into believing that transition is the answer
A pervasive theme during the webinar was that many people are being misdiagnosed with gender dysphoria, which may not be resolved by medical transition.
Allie, a 22-year-old who stopped taking testosterone after 1½ years, said she initially started the transition to male when she gave up trying to figure out why she could not identify with, or befriend, women, and after a childhood and adolescence spent mostly in the company of boys and being more interested in traditionally male activities.
She endured sexual abuse as a teenager and her parents divorced while she was in high school. Allie also had multiple suicide attempts and many incidents of self-harm. When she decided to transition, at age 18, she went to a private clinic and received cross-sex hormones within a few months of her first and only 30-minute consultation. “There was no explorative therapy,” she said, adding that she was never given a formal diagnosis of gender dysphoria.
For the first year, she said she was “over the freaking moon” because she felt like it was the answer. But things started to unravel while she attended university, and she attempted suicide attempt at age 20. A social worker at the school identified her symptoms – which had been the same since childhood – as autism. She then decided to cease her transition.
Another detransitioner, Laura Becker, said it took 5 years after her transition to recognize that she had undiagnosed PTSD from emotional and psychiatric abuse. Despite a history of substance abuse, self-harm, suicidal ideation, and other mental health issues, she was given testosterone and had a double mastectomy at age 20. She became fixated on gay men, which devolved into a methamphetamine- and crack-fueled relationship with a man she met on the gay dating platform Grindr.
“No one around me knew any better or knew how to help, including the medical professionals who performed the mastectomy and who casually signed off and administered my medical transition,” she said.
Once she was aware of her PTSD she started to detransition, which itself was traumatic, said Laura.
Limpida, aged 24, said he felt pushed into transitioning after seeking help at a Planned Parenthood clinic. He identified as trans at age 15 and spent years attempting to be a woman socially, but every step made him feel more miserable, he said. When he went to the clinic at age 21 to get estrogen, he said he felt like the staff was dismissive of his mental health concerns – including that he was suicidal, had substance abuse, and was severely depressed. He was told he was the “perfect candidate” for transitioning.
A year later, he said he felt worse. The nurse suggested he seek out surgery. After Limpida researched what was involved, he decided to detransition. He has since received an autism diagnosis.
Robin, also aged 24, said the idea of surgery had helped push him into detransitioning, which began in 2020 after 4 years of estrogen. He said he had always been gender nonconforming and knew he was gay at an early age. He believes that gender-nonconforming people are “gaslighted” into thinking that transitioning is the answer.
Lack of evidence-based, informed consent
Michelle Alleva, who stopped identifying as transgender in 2020 but had ceased testosterone 4 years earlier because of side effects, cited what she called a lack of evidence base for the effectiveness and safety of medical transitions.
“You need to have a really, really good evidence base in place if you’re going straight to an invasive treatment that is going to cause permanent changes to your body,” she said.
Access to medical transition used to involve more “gatekeeping” through mental health evaluations and other interventions, she said, but there has been a shift from treating what was considered a psychiatric issue to essentially affirming an identity.
“This shift was activist driven, not evidence based,” she emphasized.
Most studies showing satisfaction with transition only involve a few years of follow-up, she said. She added that the longest follow-up study of transition, published in 2011 and spanning 30 years, showed that the suicide rate 10-15 years post surgery was 20 times higher than the general population.
Studies of regret were primarily conducted before the rapid increase in the number of trans-identifying individuals, she said, which makes it hard to draw conclusions about pediatric transition. Getting estimates on this population is difficult because so many who detransition do not tell their clinicians, and many studies have short follow-up times or a high loss to follow-up.
Ms. Alleva also took issue with the notion that physicians were offering true informed consent, noting that it’s not possible to know if someone is psychologically sound if they haven’t had a thorough mental health evaluation and that there are so many unknowns with medical transition, including that many of the therapies are not approved for the uses being employed.
With regret on the rise, “we need professionals that are prepared for detransitioners,” said Ms. Alleva. “Some of us have lost trust in health care professionals as a result of our experience.”
“It’s a huge feeling of institutional betrayal,” said Grace.
A version of this article first appeared on Medscape.com.
In a unique Zoom conference,
The forum was convened on what was dubbed #DetransitionAwarenessDay by Genspect, a parent-based organization that seeks to put the brakes on medical transitions for children and adolescents. The group has doubts about the gender-affirming care model supported by the World Professional Association for Transgender Health, the American Medical Association, the American Academy of Pediatrics, and other medical groups.
“Affirmative” medical care is defined as treatment with puberty blockers and cross-sex hormones for those with gender dysphoria to transition to the opposite sex and is often followed by gender reassignment surgery. However, there is growing concern among many doctors and other health care professionals as to whether this is, in fact, the best way to proceed for those under aged 18, in particular, with several countries pulling back on medical treatment and instead emphasizing psychotherapy first.
The purpose of the second annual Genspect meeting was to shed light on the experiences of individuals who have detransitioned – those that identified as transgender and transitioned, but then decided to end their medical transition. People logged on from all over the United States, Canada, New Zealand, Australia, the United Kingdom, Germany, Spain, Chile, and Brazil, among other countries.
“This is a minority within a minority,” said Genspect advisor Stella O’Malley, adding that the first meeting in 2021 was held because “too many people were dismissing the stories of the detransitioners.” Ms. O’Malley is a psychotherapist, a clinical advisor to the Society for Evidence-Based Gender Medicine, and a founding member of the International Association of Therapists for Desisters and Detransitioners.
“It’s become blindingly obvious over the last year that ... ‘detrans’ is a huge part of the trans phenomenon,” said Ms. O’Malley, adding that detransitioners have been “undermined and dismissed.”
Laura Edwards-Leeper, PhD (@DrLauraEL), a prominent gender therapist who has recently expressed concern regarding adequate gatekeeping when treating youth with gender dysphoria, agreed.
She tweeted: “You simply can’t call yourself a legit gender provider if you don’t believe that detransitioners exist. As part of the informed consent process for transitioning, it is unethical to not discuss this possibility with young people.” Dr. Edwards-Leeper is professor emeritus at Pacific University in Hillsboro, Ore.
Speakers in the forum largely offered experiences, not data. They pointed out that there has been little to no study of detransition, but all testified that it was less rare than it has been portrayed by the transgender community.
Struggles with going back
“There are so many reasons why people detransition,” said Sinead Watson, aged 30, a Genspect advisor who transitioned from female to male, starting in 2015, and who decided to detransition in 2019. Citing a study by Lisa Littman, MD, MPH, published in 2021, Ms. Watson said the most common reasons for detransitioning were realizing that gender dysphoria was caused by other issues; internal homophobia; and the unbearable nature of transphobia.
Ms. Watson said the hardest part of detransitioning was admitting to herself that her transition had been a mistake. “It’s embarrassing and you feel ashamed and guilty,” she said, adding that it may mean losing friends who now regard you as a “bigot, while you’re also dealing with transition regret.”
“It’s a living hell, especially when none of your therapists or counselors will listen to you,” she said. “Detransitioning isn’t fun.”
Carol (@sourpatches2077) said she knew for a year that her transition had been a mistake.
“The biggest part was I couldn’t tell my family,” said Carol, who identifies as a lesbian. “I put them through so much. It seems ridiculous to go: ‘Oops, I made this huge [expletive] mistake,’ ” she said, describing the moment she did tell them as “devastating.”
Grace (@hormonehangover) said she remembers finally hitting a moment of “undeniability” some years after transitioning. “I accept it, I’ve ruined my life, this is wrong,” she remembers thinking. “It was devastating, but I couldn’t deny it anymore.”
Don’t trust therapists
People experiencing feelings of unease “need a therapist who will listen to them,” said Ms. Watson. When she first detransitioned, her therapists treated her badly. “They just didn’t want to speak about detransition,” she said, adding that “it was like a kick in the stomach.”
Ms. Watson said she’d like to see more training about detransition, but also on “preventative techniques,” adding that many people transition who should not. “I don’t want more detransitioners – I want less.
“In order for that to happen, we need to treat people with gender dysphoria properly,” said Ms. Watson, adding that the affirmative model is “disgusting, and that’s what needs to change.”
“I would tell somebody to not go to a therapist,” said Carol. Identifying as a butch lesbian, she felt like her therapists had pushed her into transitioning to male. “The No. 1 thing not understood by the mental health professionals is that the vast majority of homosexuals were gender-nonconforming children.” She added that this is especially true of butch lesbians.
Therapists – and doctors – also need to acknowledge both the trauma of transition and detransition, she said.
Kaiser, where she had transitioned, offered her breast reconstruction. Carol said it felt demeaning. “Like you’re Mr. Potatohead: ‘Here, we can just ... put on some new parts and you’re good to go.’ ”
“Doctors are concretizing transient obsessions,” said Helena Kerschner (@lacroicsz), quoting a chatroom user.
Ms. Kerschner gave a presentation on “fandom”: becoming obsessed with a movie, book, TV show, musician, or celebrity, spending every waking hour chatting online or writing fan fiction, or attempting to interact with the celebrity online. It’s a fantasy-dominated world and “the vast majority” of participants are teenage girls who are “identifying as trans,” in part, because they are fed a community-reinforced message that it’s better to be a boy.
Therapists and physicians who help them transition “are harming them for life based on something they would have grown out of or overcome without the permanent damage,” Ms. Kerschner added.
Doctors ‘gaslighting’ people into believing that transition is the answer
A pervasive theme during the webinar was that many people are being misdiagnosed with gender dysphoria, which may not be resolved by medical transition.
Allie, a 22-year-old who stopped taking testosterone after 1½ years, said she initially started the transition to male when she gave up trying to figure out why she could not identify with, or befriend, women, and after a childhood and adolescence spent mostly in the company of boys and being more interested in traditionally male activities.
She endured sexual abuse as a teenager and her parents divorced while she was in high school. Allie also had multiple suicide attempts and many incidents of self-harm. When she decided to transition, at age 18, she went to a private clinic and received cross-sex hormones within a few months of her first and only 30-minute consultation. “There was no explorative therapy,” she said, adding that she was never given a formal diagnosis of gender dysphoria.
For the first year, she said she was “over the freaking moon” because she felt like it was the answer. But things started to unravel while she attended university, and she attempted suicide attempt at age 20. A social worker at the school identified her symptoms – which had been the same since childhood – as autism. She then decided to cease her transition.
Another detransitioner, Laura Becker, said it took 5 years after her transition to recognize that she had undiagnosed PTSD from emotional and psychiatric abuse. Despite a history of substance abuse, self-harm, suicidal ideation, and other mental health issues, she was given testosterone and had a double mastectomy at age 20. She became fixated on gay men, which devolved into a methamphetamine- and crack-fueled relationship with a man she met on the gay dating platform Grindr.
“No one around me knew any better or knew how to help, including the medical professionals who performed the mastectomy and who casually signed off and administered my medical transition,” she said.
Once she was aware of her PTSD she started to detransition, which itself was traumatic, said Laura.
Limpida, aged 24, said he felt pushed into transitioning after seeking help at a Planned Parenthood clinic. He identified as trans at age 15 and spent years attempting to be a woman socially, but every step made him feel more miserable, he said. When he went to the clinic at age 21 to get estrogen, he said he felt like the staff was dismissive of his mental health concerns – including that he was suicidal, had substance abuse, and was severely depressed. He was told he was the “perfect candidate” for transitioning.
A year later, he said he felt worse. The nurse suggested he seek out surgery. After Limpida researched what was involved, he decided to detransition. He has since received an autism diagnosis.
Robin, also aged 24, said the idea of surgery had helped push him into detransitioning, which began in 2020 after 4 years of estrogen. He said he had always been gender nonconforming and knew he was gay at an early age. He believes that gender-nonconforming people are “gaslighted” into thinking that transitioning is the answer.
Lack of evidence-based, informed consent
Michelle Alleva, who stopped identifying as transgender in 2020 but had ceased testosterone 4 years earlier because of side effects, cited what she called a lack of evidence base for the effectiveness and safety of medical transitions.
“You need to have a really, really good evidence base in place if you’re going straight to an invasive treatment that is going to cause permanent changes to your body,” she said.
Access to medical transition used to involve more “gatekeeping” through mental health evaluations and other interventions, she said, but there has been a shift from treating what was considered a psychiatric issue to essentially affirming an identity.
“This shift was activist driven, not evidence based,” she emphasized.
Most studies showing satisfaction with transition only involve a few years of follow-up, she said. She added that the longest follow-up study of transition, published in 2011 and spanning 30 years, showed that the suicide rate 10-15 years post surgery was 20 times higher than the general population.
Studies of regret were primarily conducted before the rapid increase in the number of trans-identifying individuals, she said, which makes it hard to draw conclusions about pediatric transition. Getting estimates on this population is difficult because so many who detransition do not tell their clinicians, and many studies have short follow-up times or a high loss to follow-up.
Ms. Alleva also took issue with the notion that physicians were offering true informed consent, noting that it’s not possible to know if someone is psychologically sound if they haven’t had a thorough mental health evaluation and that there are so many unknowns with medical transition, including that many of the therapies are not approved for the uses being employed.
With regret on the rise, “we need professionals that are prepared for detransitioners,” said Ms. Alleva. “Some of us have lost trust in health care professionals as a result of our experience.”
“It’s a huge feeling of institutional betrayal,” said Grace.
A version of this article first appeared on Medscape.com.
In a unique Zoom conference,
The forum was convened on what was dubbed #DetransitionAwarenessDay by Genspect, a parent-based organization that seeks to put the brakes on medical transitions for children and adolescents. The group has doubts about the gender-affirming care model supported by the World Professional Association for Transgender Health, the American Medical Association, the American Academy of Pediatrics, and other medical groups.
“Affirmative” medical care is defined as treatment with puberty blockers and cross-sex hormones for those with gender dysphoria to transition to the opposite sex and is often followed by gender reassignment surgery. However, there is growing concern among many doctors and other health care professionals as to whether this is, in fact, the best way to proceed for those under aged 18, in particular, with several countries pulling back on medical treatment and instead emphasizing psychotherapy first.
The purpose of the second annual Genspect meeting was to shed light on the experiences of individuals who have detransitioned – those that identified as transgender and transitioned, but then decided to end their medical transition. People logged on from all over the United States, Canada, New Zealand, Australia, the United Kingdom, Germany, Spain, Chile, and Brazil, among other countries.
“This is a minority within a minority,” said Genspect advisor Stella O’Malley, adding that the first meeting in 2021 was held because “too many people were dismissing the stories of the detransitioners.” Ms. O’Malley is a psychotherapist, a clinical advisor to the Society for Evidence-Based Gender Medicine, and a founding member of the International Association of Therapists for Desisters and Detransitioners.
“It’s become blindingly obvious over the last year that ... ‘detrans’ is a huge part of the trans phenomenon,” said Ms. O’Malley, adding that detransitioners have been “undermined and dismissed.”
Laura Edwards-Leeper, PhD (@DrLauraEL), a prominent gender therapist who has recently expressed concern regarding adequate gatekeeping when treating youth with gender dysphoria, agreed.
She tweeted: “You simply can’t call yourself a legit gender provider if you don’t believe that detransitioners exist. As part of the informed consent process for transitioning, it is unethical to not discuss this possibility with young people.” Dr. Edwards-Leeper is professor emeritus at Pacific University in Hillsboro, Ore.
Speakers in the forum largely offered experiences, not data. They pointed out that there has been little to no study of detransition, but all testified that it was less rare than it has been portrayed by the transgender community.
Struggles with going back
“There are so many reasons why people detransition,” said Sinead Watson, aged 30, a Genspect advisor who transitioned from female to male, starting in 2015, and who decided to detransition in 2019. Citing a study by Lisa Littman, MD, MPH, published in 2021, Ms. Watson said the most common reasons for detransitioning were realizing that gender dysphoria was caused by other issues; internal homophobia; and the unbearable nature of transphobia.
Ms. Watson said the hardest part of detransitioning was admitting to herself that her transition had been a mistake. “It’s embarrassing and you feel ashamed and guilty,” she said, adding that it may mean losing friends who now regard you as a “bigot, while you’re also dealing with transition regret.”
“It’s a living hell, especially when none of your therapists or counselors will listen to you,” she said. “Detransitioning isn’t fun.”
Carol (@sourpatches2077) said she knew for a year that her transition had been a mistake.
“The biggest part was I couldn’t tell my family,” said Carol, who identifies as a lesbian. “I put them through so much. It seems ridiculous to go: ‘Oops, I made this huge [expletive] mistake,’ ” she said, describing the moment she did tell them as “devastating.”
Grace (@hormonehangover) said she remembers finally hitting a moment of “undeniability” some years after transitioning. “I accept it, I’ve ruined my life, this is wrong,” she remembers thinking. “It was devastating, but I couldn’t deny it anymore.”
Don’t trust therapists
People experiencing feelings of unease “need a therapist who will listen to them,” said Ms. Watson. When she first detransitioned, her therapists treated her badly. “They just didn’t want to speak about detransition,” she said, adding that “it was like a kick in the stomach.”
Ms. Watson said she’d like to see more training about detransition, but also on “preventative techniques,” adding that many people transition who should not. “I don’t want more detransitioners – I want less.
“In order for that to happen, we need to treat people with gender dysphoria properly,” said Ms. Watson, adding that the affirmative model is “disgusting, and that’s what needs to change.”
“I would tell somebody to not go to a therapist,” said Carol. Identifying as a butch lesbian, she felt like her therapists had pushed her into transitioning to male. “The No. 1 thing not understood by the mental health professionals is that the vast majority of homosexuals were gender-nonconforming children.” She added that this is especially true of butch lesbians.
Therapists – and doctors – also need to acknowledge both the trauma of transition and detransition, she said.
Kaiser, where she had transitioned, offered her breast reconstruction. Carol said it felt demeaning. “Like you’re Mr. Potatohead: ‘Here, we can just ... put on some new parts and you’re good to go.’ ”
“Doctors are concretizing transient obsessions,” said Helena Kerschner (@lacroicsz), quoting a chatroom user.
Ms. Kerschner gave a presentation on “fandom”: becoming obsessed with a movie, book, TV show, musician, or celebrity, spending every waking hour chatting online or writing fan fiction, or attempting to interact with the celebrity online. It’s a fantasy-dominated world and “the vast majority” of participants are teenage girls who are “identifying as trans,” in part, because they are fed a community-reinforced message that it’s better to be a boy.
Therapists and physicians who help them transition “are harming them for life based on something they would have grown out of or overcome without the permanent damage,” Ms. Kerschner added.
Doctors ‘gaslighting’ people into believing that transition is the answer
A pervasive theme during the webinar was that many people are being misdiagnosed with gender dysphoria, which may not be resolved by medical transition.
Allie, a 22-year-old who stopped taking testosterone after 1½ years, said she initially started the transition to male when she gave up trying to figure out why she could not identify with, or befriend, women, and after a childhood and adolescence spent mostly in the company of boys and being more interested in traditionally male activities.
She endured sexual abuse as a teenager and her parents divorced while she was in high school. Allie also had multiple suicide attempts and many incidents of self-harm. When she decided to transition, at age 18, she went to a private clinic and received cross-sex hormones within a few months of her first and only 30-minute consultation. “There was no explorative therapy,” she said, adding that she was never given a formal diagnosis of gender dysphoria.
For the first year, she said she was “over the freaking moon” because she felt like it was the answer. But things started to unravel while she attended university, and she attempted suicide attempt at age 20. A social worker at the school identified her symptoms – which had been the same since childhood – as autism. She then decided to cease her transition.
Another detransitioner, Laura Becker, said it took 5 years after her transition to recognize that she had undiagnosed PTSD from emotional and psychiatric abuse. Despite a history of substance abuse, self-harm, suicidal ideation, and other mental health issues, she was given testosterone and had a double mastectomy at age 20. She became fixated on gay men, which devolved into a methamphetamine- and crack-fueled relationship with a man she met on the gay dating platform Grindr.
“No one around me knew any better or knew how to help, including the medical professionals who performed the mastectomy and who casually signed off and administered my medical transition,” she said.
Once she was aware of her PTSD she started to detransition, which itself was traumatic, said Laura.
Limpida, aged 24, said he felt pushed into transitioning after seeking help at a Planned Parenthood clinic. He identified as trans at age 15 and spent years attempting to be a woman socially, but every step made him feel more miserable, he said. When he went to the clinic at age 21 to get estrogen, he said he felt like the staff was dismissive of his mental health concerns – including that he was suicidal, had substance abuse, and was severely depressed. He was told he was the “perfect candidate” for transitioning.
A year later, he said he felt worse. The nurse suggested he seek out surgery. After Limpida researched what was involved, he decided to detransition. He has since received an autism diagnosis.
Robin, also aged 24, said the idea of surgery had helped push him into detransitioning, which began in 2020 after 4 years of estrogen. He said he had always been gender nonconforming and knew he was gay at an early age. He believes that gender-nonconforming people are “gaslighted” into thinking that transitioning is the answer.
Lack of evidence-based, informed consent
Michelle Alleva, who stopped identifying as transgender in 2020 but had ceased testosterone 4 years earlier because of side effects, cited what she called a lack of evidence base for the effectiveness and safety of medical transitions.
“You need to have a really, really good evidence base in place if you’re going straight to an invasive treatment that is going to cause permanent changes to your body,” she said.
Access to medical transition used to involve more “gatekeeping” through mental health evaluations and other interventions, she said, but there has been a shift from treating what was considered a psychiatric issue to essentially affirming an identity.
“This shift was activist driven, not evidence based,” she emphasized.
Most studies showing satisfaction with transition only involve a few years of follow-up, she said. She added that the longest follow-up study of transition, published in 2011 and spanning 30 years, showed that the suicide rate 10-15 years post surgery was 20 times higher than the general population.
Studies of regret were primarily conducted before the rapid increase in the number of trans-identifying individuals, she said, which makes it hard to draw conclusions about pediatric transition. Getting estimates on this population is difficult because so many who detransition do not tell their clinicians, and many studies have short follow-up times or a high loss to follow-up.
Ms. Alleva also took issue with the notion that physicians were offering true informed consent, noting that it’s not possible to know if someone is psychologically sound if they haven’t had a thorough mental health evaluation and that there are so many unknowns with medical transition, including that many of the therapies are not approved for the uses being employed.
With regret on the rise, “we need professionals that are prepared for detransitioners,” said Ms. Alleva. “Some of us have lost trust in health care professionals as a result of our experience.”
“It’s a huge feeling of institutional betrayal,” said Grace.
A version of this article first appeared on Medscape.com.
Physician loses right leg, sues podiatrist; more
Pennsylvania Record, among other news sites, reports.
, as a story in theIn December 2020, Mario Adajar, MD, 59, an internist in Wyoming, Penn., sought treatment for his foot calluses and the chronic ulceration of his right foot.
Dr. Adajar consulted a podiatrist, who has surgical privileges at Wilkes-Barre Commonwealth Hospital. According to his complaint, Dr. Adajar made the podiatrist aware that he had type 2 diabetes and had recently undergone a kidney transplant.
Over the next several months, Adajar continued to be treated by the podiatrist who, among other things, debrided and cleaned his patient’s ulcerated right foot on multiple occasions. In June 2021, working out of the hospital’s Wound Healing Center, the podiatrist placed Dr. Adajar’s right leg in a total contact cast.
By the following day, the patient experienced what he later described as “excruciating” pain around the cast. He was also running a fever of 102.3. Taken to a local emergency department, Dr. Adajar soon went into septic shock, accompanied by both atrial fibrillation and acute hypoxic respiratory failure.
Doctors soon had a diagnosis: a gram-negative bacilli infection. Meanwhile, his right leg had become severely gangrenous, of the gas gangrene type. Nevertheless, after treatment, Dr. Adajar was discharged on June 15, 2021, and advised to continue with his follow-up, which included a referral to physical therapy. However, on July 27, 2021, doctors at Wilkes-Barre Commonwealth were forced to amputate Dr. Adajar’s right leg through the fibula and tibia.
In his suit, Dr. Adajar claims that the decision by the podiatrist and his associates to place him in a total contact cast was the direct and immediate cause of his injuries, most catastrophically the amputation of his right leg. He and his legal team are seeking damages “in excess of $50,000,” the standard language in Pennsylvania for cases likely to involve much larger awards.
Dr. Adajar, despite the loss of his right leg, continues to practice internal medicine.
Doctor wins forceps-delivery suit
Last month, a Virginia jury decided in favor of a physician accused of damaging a baby’s eye during delivery, a story in The Winchester Star reports.
In December 2015, Melissa Clements went to Winchester Medical Center, part of Valley Health, to have her baby delivered. Her doctor was ob.gyn. George F. Craft II, at the time a member of Winchester Women’s Specialists. At one point during the roughly 30-minute delivery, Dr. Craft used forceps to remove Ms. Clements’s baby, who in the process sustained facial fractures and left-eye damage.
At trial, Craft argued that a forceps delivery was justified because the baby was stuck and his patient had refused a C-section.
The attorney for the plaintiffs — which included Ms. Clements’s husband — claimed that the use of forceps was premature, as professional guidelines require that a woman in labor be allowed at least 3 hours to push on her own before forceps are employed. (The suit, initially filed in 2019, also accused Dr. Craft of failing to properly inform his patient about the risks of, and alternatives to, this form of delivery. That part of the complaint was dropped, however, prior to the recent trial.)
The jury debated just 50 minutes before deciding Dr. Craft wasn’t medically negligent in the birth of William, Ms. Clements’s now 6-year-old son, who will be forced to wear contact lenses or glasses for life, or undergo corrective surgery.
As Dr. Craft’s attorney explained at trial: “He [Dr. Craft] hoped to give her [Ms. Clements] what she wanted: a vaginal delivery. But forceps techniques can and will cause injuries, even when properly placed.”
Unsupervised PAs subject to med-mal cap, state says
The California Supreme Court ruled late last month that even unsupervised physician assistants (PAs) are protected under the state’s $250,000 cap on noneconomic damages, according to a posting on the website of the Claims Journal, among other news sites.
The ruling stems from a 2013 suit filed by Marisol Lopez, who claimed that a dermatologist, a plastic surgeon, and two PAs had misdiagnosed her child’s skin cancer. Ms. Lopez’s child, Olivia Sarinana, died in February 2014, causing her mother to amend her original claim to a wrongful-death suit.
A trial court found both the doctors and the PAs liable for negligence, awarding the plaintiff $11,200 in economic damages and $4.25 million in noneconomic damages. The court subsequently reduced that amount, however, referencing the state’s $250,000 limit on noneconomic damages, which is part of the Medical Injury Compensation Reform Act of 1975, known as MICRA.
Ms. Lopez appealed the decision, arguing that the cap shouldn’t apply to the two PAs, because neither was under a physician’s direct supervision and therefore not acting within the proper scope of practice, as defined by state law. Despite agreeing with the factual basis of Ms. Lopez’s claim — that neither PA was being supervised during the period in question — the trial court refused to wave the state cap. Ms. Lopez again appealed, and, in a split decision, the Second District Court of Appeal upheld the trial court’s decision.
At this point, attorneys for Ms. Lopez applied for, and obtained, a review before the state’s highest court. Last month, the justices weighed in, ruling that the PAs were still entitled to protection under MICRA because they “had valid delegation-of-service agreements in place.” In other words, while the two PAs had not been directly supervised by a physician, their services had been properly delegated by one.
Said Associate Justice Goodwin Liu, who wrote the opinion: “To be sure, there are reasonable policy arguments for excluding physician assistants who perform medical services without actual supervision from a cap on non-economic damages, and the Legislature is well equipped to weigh and reweigh the competing policy considerations. But our role is confined to interpreting the statute before us in the manner that comports most closely with the Legislature’s purpose in enacting MICRA.”
Despite the high-court ruling, voters may soon get a chance to amend the nearly 5-decades-old MICRA legislation. A November ballot initiative would not only adjust the cap for inflation, raising it to more than $1.2 million, but would also permit “judges and juries to waive the cap entirely for cases involving death and permanent disability.”
Medical groups have said that if either or both of these changes happen the cost of healthcare in the Golden State will surely go up.
The content contained in this article is for informational purposes only and does not constitute legal advice. Reliance on any information provided in this article is solely at your own risk.
A version of this article first appeared on Medscape.com.
Pennsylvania Record, among other news sites, reports.
, as a story in theIn December 2020, Mario Adajar, MD, 59, an internist in Wyoming, Penn., sought treatment for his foot calluses and the chronic ulceration of his right foot.
Dr. Adajar consulted a podiatrist, who has surgical privileges at Wilkes-Barre Commonwealth Hospital. According to his complaint, Dr. Adajar made the podiatrist aware that he had type 2 diabetes and had recently undergone a kidney transplant.
Over the next several months, Adajar continued to be treated by the podiatrist who, among other things, debrided and cleaned his patient’s ulcerated right foot on multiple occasions. In June 2021, working out of the hospital’s Wound Healing Center, the podiatrist placed Dr. Adajar’s right leg in a total contact cast.
By the following day, the patient experienced what he later described as “excruciating” pain around the cast. He was also running a fever of 102.3. Taken to a local emergency department, Dr. Adajar soon went into septic shock, accompanied by both atrial fibrillation and acute hypoxic respiratory failure.
Doctors soon had a diagnosis: a gram-negative bacilli infection. Meanwhile, his right leg had become severely gangrenous, of the gas gangrene type. Nevertheless, after treatment, Dr. Adajar was discharged on June 15, 2021, and advised to continue with his follow-up, which included a referral to physical therapy. However, on July 27, 2021, doctors at Wilkes-Barre Commonwealth were forced to amputate Dr. Adajar’s right leg through the fibula and tibia.
In his suit, Dr. Adajar claims that the decision by the podiatrist and his associates to place him in a total contact cast was the direct and immediate cause of his injuries, most catastrophically the amputation of his right leg. He and his legal team are seeking damages “in excess of $50,000,” the standard language in Pennsylvania for cases likely to involve much larger awards.
Dr. Adajar, despite the loss of his right leg, continues to practice internal medicine.
Doctor wins forceps-delivery suit
Last month, a Virginia jury decided in favor of a physician accused of damaging a baby’s eye during delivery, a story in The Winchester Star reports.
In December 2015, Melissa Clements went to Winchester Medical Center, part of Valley Health, to have her baby delivered. Her doctor was ob.gyn. George F. Craft II, at the time a member of Winchester Women’s Specialists. At one point during the roughly 30-minute delivery, Dr. Craft used forceps to remove Ms. Clements’s baby, who in the process sustained facial fractures and left-eye damage.
At trial, Craft argued that a forceps delivery was justified because the baby was stuck and his patient had refused a C-section.
The attorney for the plaintiffs — which included Ms. Clements’s husband — claimed that the use of forceps was premature, as professional guidelines require that a woman in labor be allowed at least 3 hours to push on her own before forceps are employed. (The suit, initially filed in 2019, also accused Dr. Craft of failing to properly inform his patient about the risks of, and alternatives to, this form of delivery. That part of the complaint was dropped, however, prior to the recent trial.)
The jury debated just 50 minutes before deciding Dr. Craft wasn’t medically negligent in the birth of William, Ms. Clements’s now 6-year-old son, who will be forced to wear contact lenses or glasses for life, or undergo corrective surgery.
As Dr. Craft’s attorney explained at trial: “He [Dr. Craft] hoped to give her [Ms. Clements] what she wanted: a vaginal delivery. But forceps techniques can and will cause injuries, even when properly placed.”
Unsupervised PAs subject to med-mal cap, state says
The California Supreme Court ruled late last month that even unsupervised physician assistants (PAs) are protected under the state’s $250,000 cap on noneconomic damages, according to a posting on the website of the Claims Journal, among other news sites.
The ruling stems from a 2013 suit filed by Marisol Lopez, who claimed that a dermatologist, a plastic surgeon, and two PAs had misdiagnosed her child’s skin cancer. Ms. Lopez’s child, Olivia Sarinana, died in February 2014, causing her mother to amend her original claim to a wrongful-death suit.
A trial court found both the doctors and the PAs liable for negligence, awarding the plaintiff $11,200 in economic damages and $4.25 million in noneconomic damages. The court subsequently reduced that amount, however, referencing the state’s $250,000 limit on noneconomic damages, which is part of the Medical Injury Compensation Reform Act of 1975, known as MICRA.
Ms. Lopez appealed the decision, arguing that the cap shouldn’t apply to the two PAs, because neither was under a physician’s direct supervision and therefore not acting within the proper scope of practice, as defined by state law. Despite agreeing with the factual basis of Ms. Lopez’s claim — that neither PA was being supervised during the period in question — the trial court refused to wave the state cap. Ms. Lopez again appealed, and, in a split decision, the Second District Court of Appeal upheld the trial court’s decision.
At this point, attorneys for Ms. Lopez applied for, and obtained, a review before the state’s highest court. Last month, the justices weighed in, ruling that the PAs were still entitled to protection under MICRA because they “had valid delegation-of-service agreements in place.” In other words, while the two PAs had not been directly supervised by a physician, their services had been properly delegated by one.
Said Associate Justice Goodwin Liu, who wrote the opinion: “To be sure, there are reasonable policy arguments for excluding physician assistants who perform medical services without actual supervision from a cap on non-economic damages, and the Legislature is well equipped to weigh and reweigh the competing policy considerations. But our role is confined to interpreting the statute before us in the manner that comports most closely with the Legislature’s purpose in enacting MICRA.”
Despite the high-court ruling, voters may soon get a chance to amend the nearly 5-decades-old MICRA legislation. A November ballot initiative would not only adjust the cap for inflation, raising it to more than $1.2 million, but would also permit “judges and juries to waive the cap entirely for cases involving death and permanent disability.”
Medical groups have said that if either or both of these changes happen the cost of healthcare in the Golden State will surely go up.
The content contained in this article is for informational purposes only and does not constitute legal advice. Reliance on any information provided in this article is solely at your own risk.
A version of this article first appeared on Medscape.com.
Pennsylvania Record, among other news sites, reports.
, as a story in theIn December 2020, Mario Adajar, MD, 59, an internist in Wyoming, Penn., sought treatment for his foot calluses and the chronic ulceration of his right foot.
Dr. Adajar consulted a podiatrist, who has surgical privileges at Wilkes-Barre Commonwealth Hospital. According to his complaint, Dr. Adajar made the podiatrist aware that he had type 2 diabetes and had recently undergone a kidney transplant.
Over the next several months, Adajar continued to be treated by the podiatrist who, among other things, debrided and cleaned his patient’s ulcerated right foot on multiple occasions. In June 2021, working out of the hospital’s Wound Healing Center, the podiatrist placed Dr. Adajar’s right leg in a total contact cast.
By the following day, the patient experienced what he later described as “excruciating” pain around the cast. He was also running a fever of 102.3. Taken to a local emergency department, Dr. Adajar soon went into septic shock, accompanied by both atrial fibrillation and acute hypoxic respiratory failure.
Doctors soon had a diagnosis: a gram-negative bacilli infection. Meanwhile, his right leg had become severely gangrenous, of the gas gangrene type. Nevertheless, after treatment, Dr. Adajar was discharged on June 15, 2021, and advised to continue with his follow-up, which included a referral to physical therapy. However, on July 27, 2021, doctors at Wilkes-Barre Commonwealth were forced to amputate Dr. Adajar’s right leg through the fibula and tibia.
In his suit, Dr. Adajar claims that the decision by the podiatrist and his associates to place him in a total contact cast was the direct and immediate cause of his injuries, most catastrophically the amputation of his right leg. He and his legal team are seeking damages “in excess of $50,000,” the standard language in Pennsylvania for cases likely to involve much larger awards.
Dr. Adajar, despite the loss of his right leg, continues to practice internal medicine.
Doctor wins forceps-delivery suit
Last month, a Virginia jury decided in favor of a physician accused of damaging a baby’s eye during delivery, a story in The Winchester Star reports.
In December 2015, Melissa Clements went to Winchester Medical Center, part of Valley Health, to have her baby delivered. Her doctor was ob.gyn. George F. Craft II, at the time a member of Winchester Women’s Specialists. At one point during the roughly 30-minute delivery, Dr. Craft used forceps to remove Ms. Clements’s baby, who in the process sustained facial fractures and left-eye damage.
At trial, Craft argued that a forceps delivery was justified because the baby was stuck and his patient had refused a C-section.
The attorney for the plaintiffs — which included Ms. Clements’s husband — claimed that the use of forceps was premature, as professional guidelines require that a woman in labor be allowed at least 3 hours to push on her own before forceps are employed. (The suit, initially filed in 2019, also accused Dr. Craft of failing to properly inform his patient about the risks of, and alternatives to, this form of delivery. That part of the complaint was dropped, however, prior to the recent trial.)
The jury debated just 50 minutes before deciding Dr. Craft wasn’t medically negligent in the birth of William, Ms. Clements’s now 6-year-old son, who will be forced to wear contact lenses or glasses for life, or undergo corrective surgery.
As Dr. Craft’s attorney explained at trial: “He [Dr. Craft] hoped to give her [Ms. Clements] what she wanted: a vaginal delivery. But forceps techniques can and will cause injuries, even when properly placed.”
Unsupervised PAs subject to med-mal cap, state says
The California Supreme Court ruled late last month that even unsupervised physician assistants (PAs) are protected under the state’s $250,000 cap on noneconomic damages, according to a posting on the website of the Claims Journal, among other news sites.
The ruling stems from a 2013 suit filed by Marisol Lopez, who claimed that a dermatologist, a plastic surgeon, and two PAs had misdiagnosed her child’s skin cancer. Ms. Lopez’s child, Olivia Sarinana, died in February 2014, causing her mother to amend her original claim to a wrongful-death suit.
A trial court found both the doctors and the PAs liable for negligence, awarding the plaintiff $11,200 in economic damages and $4.25 million in noneconomic damages. The court subsequently reduced that amount, however, referencing the state’s $250,000 limit on noneconomic damages, which is part of the Medical Injury Compensation Reform Act of 1975, known as MICRA.
Ms. Lopez appealed the decision, arguing that the cap shouldn’t apply to the two PAs, because neither was under a physician’s direct supervision and therefore not acting within the proper scope of practice, as defined by state law. Despite agreeing with the factual basis of Ms. Lopez’s claim — that neither PA was being supervised during the period in question — the trial court refused to wave the state cap. Ms. Lopez again appealed, and, in a split decision, the Second District Court of Appeal upheld the trial court’s decision.
At this point, attorneys for Ms. Lopez applied for, and obtained, a review before the state’s highest court. Last month, the justices weighed in, ruling that the PAs were still entitled to protection under MICRA because they “had valid delegation-of-service agreements in place.” In other words, while the two PAs had not been directly supervised by a physician, their services had been properly delegated by one.
Said Associate Justice Goodwin Liu, who wrote the opinion: “To be sure, there are reasonable policy arguments for excluding physician assistants who perform medical services without actual supervision from a cap on non-economic damages, and the Legislature is well equipped to weigh and reweigh the competing policy considerations. But our role is confined to interpreting the statute before us in the manner that comports most closely with the Legislature’s purpose in enacting MICRA.”
Despite the high-court ruling, voters may soon get a chance to amend the nearly 5-decades-old MICRA legislation. A November ballot initiative would not only adjust the cap for inflation, raising it to more than $1.2 million, but would also permit “judges and juries to waive the cap entirely for cases involving death and permanent disability.”
Medical groups have said that if either or both of these changes happen the cost of healthcare in the Golden State will surely go up.
The content contained in this article is for informational purposes only and does not constitute legal advice. Reliance on any information provided in this article is solely at your own risk.
A version of this article first appeared on Medscape.com.
Is cancer testing going to the dogs? Nope, ants
The oncologist’s new best friend
We know that dogs have very sensitive noses. They can track criminals and missing persons and sniff out drugs and bombs. They can even detect cancer cells … after months of training.
And then there are ants.
Cancer cells produce volatile organic compounds (VOCs), which can be sniffed out by dogs and other animals with sufficiently sophisticated olfactory senses. A group of French investigators decided to find out if Formica fusca is such an animal.
First, they placed breast cancer cells and healthy cells in a petri dish. The sample of cancer cells, however, included a sugary treat. “Over successive trials, the ants got quicker and quicker at finding the treat, indicating that they had learned to recognize the VOCs produced by the cancerous cells, using these as a beacon to guide their way to the sugary delight,” according to IFL Science.
When the researchers removed the treat, the ants still went straight for the cancer cells. Then they removed the healthy cells and substituted another type of breast cancer cell, with just one type getting the treat. They went for the cancer cells with the treat, “indicating that they were capable of distinguishing between the different cancer types based on the unique pattern of VOCs emitted by each one,” IFL Science explained.
It’s just another chapter in the eternal struggle between dogs and ants. Dogs need months of training to learn to detect cancer cells; ants can do it in 30 minutes. Over the course of a dog’s training, Fido eats more food than 10,000 ants combined. (Okay, we’re guessing here, but it’s got to be a pretty big number, right?)
Then there’s the warm and fuzzy factor. Just look at that picture. Who wouldn’t want a cutie like that curling up in the bed next to you?
Console War II: Battle of the Twitter users
Video games can be a lot of fun, provided you’re not playing something like Rock Simulator. Or Surgeon Simulator. Or Surgeon Simulator 2. Yes, those are all real games. But calling yourself a video gamer invites a certain negative connotation, and nowhere can that be better exemplified than the increasingly ridiculous console war.
For those who don’t know their video game history, back in the early 90s Nintendo and Sega were the main video game console makers. Nintendo had Mario, Sega had Sonic, and everyone had an opinion on which was best. With Sega now but a shell of its former self and Nintendo viewed as too “casual” for the true gaming connoisseur, today’s battle pits Playstation against Xbox, and fans of both consoles spend their time trying to one-up each other in increasingly silly online arguments.
That brings us nicely to a Twitter user named “Shreeveera,” who is very vocal about his love of Playstation and hatred of the Xbox. Importantly, for LOTME purposes, Shreeveera identified himself as a doctor on his profile, and in the middle of an argument, Xbox enthusiasts called his credentials into question.
At this point, most people would recognize that there are very few noteworthy console-exclusive video games in today’s world and that any argument about consoles essentially comes down to which console design you like or which company you find less distasteful, and they would step away from the Twitter argument. Shreeveera is not most people, and he decided the next logical move was to post a video of himself and an anesthetized patient about to undergo a laparoscopic cholecystectomy.
This move did prove that he was indeed a doctor, but the ethics of posting such a video with a patient in the room is a bit dubious at best. Since Shreeveera also listed the hospital he worked at, numerous Twitter users review bombed the hospital with one-star reviews. Shreeveera’s fate is unknown, but he did take down the video and removed “doctor by profession” from his profile. He also made a second video asking Twitter to stop trying to ruin his life. We’re sure that’ll go well. Twitter is known for being completely fair and reasonable.
Use your words to gain power
We live in the age of the emoji. The use of emojis in texts and emails is basically the new shorthand. It’s a fun and easy way to chat with people close to us, but a new study shows that it doesn’t help in a business setting. In fact, it may do a little damage.
The use of images such as emojis in communication or logos can make a person seem less powerful than someone who opts for written words, according to Elinor Amit, PhD, of Tel Aviv University and associates.
Participants in their study were asked to imagine shopping with a person wearing a T-shirt. Half were then shown the logo of the Red Sox baseball team and half saw the words “Red Sox.” In another scenario, they were asked to imagine attending a retreat of a company called Lotus. Then half were shown an employee wearing a shirt with an image of lotus flower and half saw the verbal logo “Lotus.” In both scenarios, the individuals wearing shirts with images were seen as less powerful than the people who wore shirts with words on them.
Why is that? In a Eurekalert statement, Dr. Amit said that “visual messages are often interpreted as a signal for desire for social proximity.” In a world with COVID-19, that could give anyone pause.
That desire for more social proximity, in turn, equals a suggested loss of power because research shows that people who want to be around other people more are less powerful than people who don’t.
With the reduced social proximity we have these days, we may want to keep things cool and lighthearted, especially in work emails with people who we’ve never met. It may be, however, that using your words to say thank you in the multitude of emails you respond to on a regular basis is better than that thumbs-up emoji. Nobody will think less of you.
Should Daylight Savings Time still be a thing?
This past week, we just experienced the spring-forward portion of Daylight Savings Time, which took an hour of sleep away from us all. Some of us may still be struggling to find our footing with the time change, but at least it’s still sunny out at 7 pm. For those who don’t really see the point of changing the clocks twice a year, there are actually some good reasons to do so.
Sen. Marco Rubio, sponsor of a bill to make the time change permanent, put it simply: “If we can get this passed, we don’t have to do this stupidity anymore.” Message received, apparently, since the measure just passed unanimously in the Senate.
It’s not clear if President Biden will approve it, though, because there’s a lot that comes into play: economic needs, seasonal depression, and safety.
“I know this is not the most important issue confronting America, but it’s one of those issues where there’s a lot of agreement,” Sen. Rubio said.
Not total agreement, though. The National Association of Convenience Stores is opposed to the bill, and Reuters noted that one witness at a recent hearing said the time change “is like living in the wrong time zone for almost eight months out of the year.”
Many people, however, seem to be leaning toward the permanent spring-forward as it gives businesses a longer window to provide entertainment in the evenings and kids are able to play outside longer after school.
Honestly, we’re leaning toward whichever one can reduce seasonal depression.
The oncologist’s new best friend
We know that dogs have very sensitive noses. They can track criminals and missing persons and sniff out drugs and bombs. They can even detect cancer cells … after months of training.
And then there are ants.
Cancer cells produce volatile organic compounds (VOCs), which can be sniffed out by dogs and other animals with sufficiently sophisticated olfactory senses. A group of French investigators decided to find out if Formica fusca is such an animal.
First, they placed breast cancer cells and healthy cells in a petri dish. The sample of cancer cells, however, included a sugary treat. “Over successive trials, the ants got quicker and quicker at finding the treat, indicating that they had learned to recognize the VOCs produced by the cancerous cells, using these as a beacon to guide their way to the sugary delight,” according to IFL Science.
When the researchers removed the treat, the ants still went straight for the cancer cells. Then they removed the healthy cells and substituted another type of breast cancer cell, with just one type getting the treat. They went for the cancer cells with the treat, “indicating that they were capable of distinguishing between the different cancer types based on the unique pattern of VOCs emitted by each one,” IFL Science explained.
It’s just another chapter in the eternal struggle between dogs and ants. Dogs need months of training to learn to detect cancer cells; ants can do it in 30 minutes. Over the course of a dog’s training, Fido eats more food than 10,000 ants combined. (Okay, we’re guessing here, but it’s got to be a pretty big number, right?)
Then there’s the warm and fuzzy factor. Just look at that picture. Who wouldn’t want a cutie like that curling up in the bed next to you?
Console War II: Battle of the Twitter users
Video games can be a lot of fun, provided you’re not playing something like Rock Simulator. Or Surgeon Simulator. Or Surgeon Simulator 2. Yes, those are all real games. But calling yourself a video gamer invites a certain negative connotation, and nowhere can that be better exemplified than the increasingly ridiculous console war.
For those who don’t know their video game history, back in the early 90s Nintendo and Sega were the main video game console makers. Nintendo had Mario, Sega had Sonic, and everyone had an opinion on which was best. With Sega now but a shell of its former self and Nintendo viewed as too “casual” for the true gaming connoisseur, today’s battle pits Playstation against Xbox, and fans of both consoles spend their time trying to one-up each other in increasingly silly online arguments.
That brings us nicely to a Twitter user named “Shreeveera,” who is very vocal about his love of Playstation and hatred of the Xbox. Importantly, for LOTME purposes, Shreeveera identified himself as a doctor on his profile, and in the middle of an argument, Xbox enthusiasts called his credentials into question.
At this point, most people would recognize that there are very few noteworthy console-exclusive video games in today’s world and that any argument about consoles essentially comes down to which console design you like or which company you find less distasteful, and they would step away from the Twitter argument. Shreeveera is not most people, and he decided the next logical move was to post a video of himself and an anesthetized patient about to undergo a laparoscopic cholecystectomy.
This move did prove that he was indeed a doctor, but the ethics of posting such a video with a patient in the room is a bit dubious at best. Since Shreeveera also listed the hospital he worked at, numerous Twitter users review bombed the hospital with one-star reviews. Shreeveera’s fate is unknown, but he did take down the video and removed “doctor by profession” from his profile. He also made a second video asking Twitter to stop trying to ruin his life. We’re sure that’ll go well. Twitter is known for being completely fair and reasonable.
Use your words to gain power
We live in the age of the emoji. The use of emojis in texts and emails is basically the new shorthand. It’s a fun and easy way to chat with people close to us, but a new study shows that it doesn’t help in a business setting. In fact, it may do a little damage.
The use of images such as emojis in communication or logos can make a person seem less powerful than someone who opts for written words, according to Elinor Amit, PhD, of Tel Aviv University and associates.
Participants in their study were asked to imagine shopping with a person wearing a T-shirt. Half were then shown the logo of the Red Sox baseball team and half saw the words “Red Sox.” In another scenario, they were asked to imagine attending a retreat of a company called Lotus. Then half were shown an employee wearing a shirt with an image of lotus flower and half saw the verbal logo “Lotus.” In both scenarios, the individuals wearing shirts with images were seen as less powerful than the people who wore shirts with words on them.
Why is that? In a Eurekalert statement, Dr. Amit said that “visual messages are often interpreted as a signal for desire for social proximity.” In a world with COVID-19, that could give anyone pause.
That desire for more social proximity, in turn, equals a suggested loss of power because research shows that people who want to be around other people more are less powerful than people who don’t.
With the reduced social proximity we have these days, we may want to keep things cool and lighthearted, especially in work emails with people who we’ve never met. It may be, however, that using your words to say thank you in the multitude of emails you respond to on a regular basis is better than that thumbs-up emoji. Nobody will think less of you.
Should Daylight Savings Time still be a thing?
This past week, we just experienced the spring-forward portion of Daylight Savings Time, which took an hour of sleep away from us all. Some of us may still be struggling to find our footing with the time change, but at least it’s still sunny out at 7 pm. For those who don’t really see the point of changing the clocks twice a year, there are actually some good reasons to do so.
Sen. Marco Rubio, sponsor of a bill to make the time change permanent, put it simply: “If we can get this passed, we don’t have to do this stupidity anymore.” Message received, apparently, since the measure just passed unanimously in the Senate.
It’s not clear if President Biden will approve it, though, because there’s a lot that comes into play: economic needs, seasonal depression, and safety.
“I know this is not the most important issue confronting America, but it’s one of those issues where there’s a lot of agreement,” Sen. Rubio said.
Not total agreement, though. The National Association of Convenience Stores is opposed to the bill, and Reuters noted that one witness at a recent hearing said the time change “is like living in the wrong time zone for almost eight months out of the year.”
Many people, however, seem to be leaning toward the permanent spring-forward as it gives businesses a longer window to provide entertainment in the evenings and kids are able to play outside longer after school.
Honestly, we’re leaning toward whichever one can reduce seasonal depression.
The oncologist’s new best friend
We know that dogs have very sensitive noses. They can track criminals and missing persons and sniff out drugs and bombs. They can even detect cancer cells … after months of training.
And then there are ants.
Cancer cells produce volatile organic compounds (VOCs), which can be sniffed out by dogs and other animals with sufficiently sophisticated olfactory senses. A group of French investigators decided to find out if Formica fusca is such an animal.
First, they placed breast cancer cells and healthy cells in a petri dish. The sample of cancer cells, however, included a sugary treat. “Over successive trials, the ants got quicker and quicker at finding the treat, indicating that they had learned to recognize the VOCs produced by the cancerous cells, using these as a beacon to guide their way to the sugary delight,” according to IFL Science.
When the researchers removed the treat, the ants still went straight for the cancer cells. Then they removed the healthy cells and substituted another type of breast cancer cell, with just one type getting the treat. They went for the cancer cells with the treat, “indicating that they were capable of distinguishing between the different cancer types based on the unique pattern of VOCs emitted by each one,” IFL Science explained.
It’s just another chapter in the eternal struggle between dogs and ants. Dogs need months of training to learn to detect cancer cells; ants can do it in 30 minutes. Over the course of a dog’s training, Fido eats more food than 10,000 ants combined. (Okay, we’re guessing here, but it’s got to be a pretty big number, right?)
Then there’s the warm and fuzzy factor. Just look at that picture. Who wouldn’t want a cutie like that curling up in the bed next to you?
Console War II: Battle of the Twitter users
Video games can be a lot of fun, provided you’re not playing something like Rock Simulator. Or Surgeon Simulator. Or Surgeon Simulator 2. Yes, those are all real games. But calling yourself a video gamer invites a certain negative connotation, and nowhere can that be better exemplified than the increasingly ridiculous console war.
For those who don’t know their video game history, back in the early 90s Nintendo and Sega were the main video game console makers. Nintendo had Mario, Sega had Sonic, and everyone had an opinion on which was best. With Sega now but a shell of its former self and Nintendo viewed as too “casual” for the true gaming connoisseur, today’s battle pits Playstation against Xbox, and fans of both consoles spend their time trying to one-up each other in increasingly silly online arguments.
That brings us nicely to a Twitter user named “Shreeveera,” who is very vocal about his love of Playstation and hatred of the Xbox. Importantly, for LOTME purposes, Shreeveera identified himself as a doctor on his profile, and in the middle of an argument, Xbox enthusiasts called his credentials into question.
At this point, most people would recognize that there are very few noteworthy console-exclusive video games in today’s world and that any argument about consoles essentially comes down to which console design you like or which company you find less distasteful, and they would step away from the Twitter argument. Shreeveera is not most people, and he decided the next logical move was to post a video of himself and an anesthetized patient about to undergo a laparoscopic cholecystectomy.
This move did prove that he was indeed a doctor, but the ethics of posting such a video with a patient in the room is a bit dubious at best. Since Shreeveera also listed the hospital he worked at, numerous Twitter users review bombed the hospital with one-star reviews. Shreeveera’s fate is unknown, but he did take down the video and removed “doctor by profession” from his profile. He also made a second video asking Twitter to stop trying to ruin his life. We’re sure that’ll go well. Twitter is known for being completely fair and reasonable.
Use your words to gain power
We live in the age of the emoji. The use of emojis in texts and emails is basically the new shorthand. It’s a fun and easy way to chat with people close to us, but a new study shows that it doesn’t help in a business setting. In fact, it may do a little damage.
The use of images such as emojis in communication or logos can make a person seem less powerful than someone who opts for written words, according to Elinor Amit, PhD, of Tel Aviv University and associates.
Participants in their study were asked to imagine shopping with a person wearing a T-shirt. Half were then shown the logo of the Red Sox baseball team and half saw the words “Red Sox.” In another scenario, they were asked to imagine attending a retreat of a company called Lotus. Then half were shown an employee wearing a shirt with an image of lotus flower and half saw the verbal logo “Lotus.” In both scenarios, the individuals wearing shirts with images were seen as less powerful than the people who wore shirts with words on them.
Why is that? In a Eurekalert statement, Dr. Amit said that “visual messages are often interpreted as a signal for desire for social proximity.” In a world with COVID-19, that could give anyone pause.
That desire for more social proximity, in turn, equals a suggested loss of power because research shows that people who want to be around other people more are less powerful than people who don’t.
With the reduced social proximity we have these days, we may want to keep things cool and lighthearted, especially in work emails with people who we’ve never met. It may be, however, that using your words to say thank you in the multitude of emails you respond to on a regular basis is better than that thumbs-up emoji. Nobody will think less of you.
Should Daylight Savings Time still be a thing?
This past week, we just experienced the spring-forward portion of Daylight Savings Time, which took an hour of sleep away from us all. Some of us may still be struggling to find our footing with the time change, but at least it’s still sunny out at 7 pm. For those who don’t really see the point of changing the clocks twice a year, there are actually some good reasons to do so.
Sen. Marco Rubio, sponsor of a bill to make the time change permanent, put it simply: “If we can get this passed, we don’t have to do this stupidity anymore.” Message received, apparently, since the measure just passed unanimously in the Senate.
It’s not clear if President Biden will approve it, though, because there’s a lot that comes into play: economic needs, seasonal depression, and safety.
“I know this is not the most important issue confronting America, but it’s one of those issues where there’s a lot of agreement,” Sen. Rubio said.
Not total agreement, though. The National Association of Convenience Stores is opposed to the bill, and Reuters noted that one witness at a recent hearing said the time change “is like living in the wrong time zone for almost eight months out of the year.”
Many people, however, seem to be leaning toward the permanent spring-forward as it gives businesses a longer window to provide entertainment in the evenings and kids are able to play outside longer after school.
Honestly, we’re leaning toward whichever one can reduce seasonal depression.
Cardiologists say rights to maternity leave violated
A survey of 323 women cardiologists who were working while they were pregnant showed that nearly 75% experienced discriminatory maternity-leave practices, some of which were likely violations of the Family and Medical Leave Act (FMLA).
More than 40% saw their salaries decreased during their year of pregnancy, 38% were required to perform extra service or call before taking maternity leave, exposing them to occupational hazards such as radiation, and 40% experienced a pregnancy complication, significantly higher than the general population and other medical specialties.
Additionally, of those who performed extra service or call, 18% were placed on bedrest before delivery, compared with 7.4% who did not perform extra service or call.
More than half of respondents reported that pregnancy negatively impacted their careers, and 42.4% said they experienced pressure to return to work and a delay in promotions, both illegal practices under the FMLA.
The survey is published in the Journal of the American College of Cardiology.
“Childbearing is difficult for women in cardiology with more than double the rate of gestational complications of the U.S. population, frequent income loss out of proportion to reduced productivity, and for nearly half, has an adverse impact on their career,” lead author Martha Gulati, MD, University of Arizona, Phoenix, said in a statement.
“While many professions struggle to create environments supportive of pregnancy and child-rearing, the prevalence of illegal behavior in cardiology is quite high and presents substantial legal risk for employers,” Dr. Gulati added.
C. Noel Bairey Merz, MD, professor of cardiology at Cedars-Sinai Smidt Heart Institute, Los Angeles, and a coauthor of the survey, told this news organization that it’s not surprising that such a situation exists, even “in this day and age.”
“I’m not surprised as a woman in cardiology myself. I was told by my training director that if I took off more than my allowed sick leave when I had my first and second children, I would have to repeat the year of training, so not surprised at all. I hear this from colleagues all the time,” Dr. Bairey Merz said.
The exchange left her feeling fearful for her career.
“Who wants to repeat a year? It pushes you back from a career standpoint, financially, everything. It also made me angry. I had a colleague who busted his leg in a motorcycle accident. He was unable to do any procedures for 16 weeks, and he didn’t have to repeat the year,” she pointed out.
The challenge that pregnancy represents is frequently cited by women as a deterrent for applying for a cardiology fellowship, Laxmi S. Mehta, MD, Ohio State University, Columbus, and colleagues wrote in an accompanying editorial.
The findings from the survey “reveal restrictive maternity leave data in a profession that has historically and currently continues to have a diversity problem,” they wrote.
“Maternity and pregnancy issues are a thing in cardiology,” Dr. Mehta said in an interview. “It’s one of the reasons why women get deterred from going into the field. It makes it challenging to choose cardiology if you perceive that the culture is negative, that it’s hard to be pregnant, or to bear children, or to take care of them post partum. It is problematic and it should not be occurring now.”
Leadership that condones such restrictive policies or even promotes them through ignorance and inaction needs to be held accountable, she added.
“We need to move forward from this negativity and make it more warm and welcoming to have families, whether you are a trainee or a practicing cardiologist, male or female. We need transparent and consistent parental leave policies and things like lactation support when a woman returns to work. That is a big issue,” Dr. Mehta said.
Having cardiovascular leaders champion the cause of adequate maternity and paternity leave are crucial to creating a newer, inclusive environment in cardiology.
As an example, Dr. Mehta recounted her own experience when she was in training 17 years ago.
“When I interviewed for a cardiology fellowship, one of the female program directors asked me if I was planning to have children, because if I did, the other fellows wouldn’t like it if they had to cover for me,” she said. “I ended up doing my fellowship where the chief of cardiology encouraged me to have children. He said: ‘Have your children during training, we will support you.’ And he did. I still had to do all of the call make-up and that stuff, but I worked in a supportive environment, and it made all the difference.”
“It’s about allyship,” she added. “You will have some people who are supportive and some who are not, but when you have the chief supporting you, you have a strong ally.”
The researchers suggest that one strategy is to temporarily replace cardiologists on maternity leave with locums, or “deepen the bench of coverage for clinical work, as is done for other absences. Given the expanding coverage of parental and family medical leaves, and awareness of these issues nationally, the need for this is likely to become less of an exception and more the rule.”
For example, nine states and Washington, D.C. now provide paid parental leave, they wrote, “and there is pending legislation in others.”
Dr. Bairey Merz and Dr. Mehta reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
A survey of 323 women cardiologists who were working while they were pregnant showed that nearly 75% experienced discriminatory maternity-leave practices, some of which were likely violations of the Family and Medical Leave Act (FMLA).
More than 40% saw their salaries decreased during their year of pregnancy, 38% were required to perform extra service or call before taking maternity leave, exposing them to occupational hazards such as radiation, and 40% experienced a pregnancy complication, significantly higher than the general population and other medical specialties.
Additionally, of those who performed extra service or call, 18% were placed on bedrest before delivery, compared with 7.4% who did not perform extra service or call.
More than half of respondents reported that pregnancy negatively impacted their careers, and 42.4% said they experienced pressure to return to work and a delay in promotions, both illegal practices under the FMLA.
The survey is published in the Journal of the American College of Cardiology.
“Childbearing is difficult for women in cardiology with more than double the rate of gestational complications of the U.S. population, frequent income loss out of proportion to reduced productivity, and for nearly half, has an adverse impact on their career,” lead author Martha Gulati, MD, University of Arizona, Phoenix, said in a statement.
“While many professions struggle to create environments supportive of pregnancy and child-rearing, the prevalence of illegal behavior in cardiology is quite high and presents substantial legal risk for employers,” Dr. Gulati added.
C. Noel Bairey Merz, MD, professor of cardiology at Cedars-Sinai Smidt Heart Institute, Los Angeles, and a coauthor of the survey, told this news organization that it’s not surprising that such a situation exists, even “in this day and age.”
“I’m not surprised as a woman in cardiology myself. I was told by my training director that if I took off more than my allowed sick leave when I had my first and second children, I would have to repeat the year of training, so not surprised at all. I hear this from colleagues all the time,” Dr. Bairey Merz said.
The exchange left her feeling fearful for her career.
“Who wants to repeat a year? It pushes you back from a career standpoint, financially, everything. It also made me angry. I had a colleague who busted his leg in a motorcycle accident. He was unable to do any procedures for 16 weeks, and he didn’t have to repeat the year,” she pointed out.
The challenge that pregnancy represents is frequently cited by women as a deterrent for applying for a cardiology fellowship, Laxmi S. Mehta, MD, Ohio State University, Columbus, and colleagues wrote in an accompanying editorial.
The findings from the survey “reveal restrictive maternity leave data in a profession that has historically and currently continues to have a diversity problem,” they wrote.
“Maternity and pregnancy issues are a thing in cardiology,” Dr. Mehta said in an interview. “It’s one of the reasons why women get deterred from going into the field. It makes it challenging to choose cardiology if you perceive that the culture is negative, that it’s hard to be pregnant, or to bear children, or to take care of them post partum. It is problematic and it should not be occurring now.”
Leadership that condones such restrictive policies or even promotes them through ignorance and inaction needs to be held accountable, she added.
“We need to move forward from this negativity and make it more warm and welcoming to have families, whether you are a trainee or a practicing cardiologist, male or female. We need transparent and consistent parental leave policies and things like lactation support when a woman returns to work. That is a big issue,” Dr. Mehta said.
Having cardiovascular leaders champion the cause of adequate maternity and paternity leave are crucial to creating a newer, inclusive environment in cardiology.
As an example, Dr. Mehta recounted her own experience when she was in training 17 years ago.
“When I interviewed for a cardiology fellowship, one of the female program directors asked me if I was planning to have children, because if I did, the other fellows wouldn’t like it if they had to cover for me,” she said. “I ended up doing my fellowship where the chief of cardiology encouraged me to have children. He said: ‘Have your children during training, we will support you.’ And he did. I still had to do all of the call make-up and that stuff, but I worked in a supportive environment, and it made all the difference.”
“It’s about allyship,” she added. “You will have some people who are supportive and some who are not, but when you have the chief supporting you, you have a strong ally.”
The researchers suggest that one strategy is to temporarily replace cardiologists on maternity leave with locums, or “deepen the bench of coverage for clinical work, as is done for other absences. Given the expanding coverage of parental and family medical leaves, and awareness of these issues nationally, the need for this is likely to become less of an exception and more the rule.”
For example, nine states and Washington, D.C. now provide paid parental leave, they wrote, “and there is pending legislation in others.”
Dr. Bairey Merz and Dr. Mehta reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
A survey of 323 women cardiologists who were working while they were pregnant showed that nearly 75% experienced discriminatory maternity-leave practices, some of which were likely violations of the Family and Medical Leave Act (FMLA).
More than 40% saw their salaries decreased during their year of pregnancy, 38% were required to perform extra service or call before taking maternity leave, exposing them to occupational hazards such as radiation, and 40% experienced a pregnancy complication, significantly higher than the general population and other medical specialties.
Additionally, of those who performed extra service or call, 18% were placed on bedrest before delivery, compared with 7.4% who did not perform extra service or call.
More than half of respondents reported that pregnancy negatively impacted their careers, and 42.4% said they experienced pressure to return to work and a delay in promotions, both illegal practices under the FMLA.
The survey is published in the Journal of the American College of Cardiology.
“Childbearing is difficult for women in cardiology with more than double the rate of gestational complications of the U.S. population, frequent income loss out of proportion to reduced productivity, and for nearly half, has an adverse impact on their career,” lead author Martha Gulati, MD, University of Arizona, Phoenix, said in a statement.
“While many professions struggle to create environments supportive of pregnancy and child-rearing, the prevalence of illegal behavior in cardiology is quite high and presents substantial legal risk for employers,” Dr. Gulati added.
C. Noel Bairey Merz, MD, professor of cardiology at Cedars-Sinai Smidt Heart Institute, Los Angeles, and a coauthor of the survey, told this news organization that it’s not surprising that such a situation exists, even “in this day and age.”
“I’m not surprised as a woman in cardiology myself. I was told by my training director that if I took off more than my allowed sick leave when I had my first and second children, I would have to repeat the year of training, so not surprised at all. I hear this from colleagues all the time,” Dr. Bairey Merz said.
The exchange left her feeling fearful for her career.
“Who wants to repeat a year? It pushes you back from a career standpoint, financially, everything. It also made me angry. I had a colleague who busted his leg in a motorcycle accident. He was unable to do any procedures for 16 weeks, and he didn’t have to repeat the year,” she pointed out.
The challenge that pregnancy represents is frequently cited by women as a deterrent for applying for a cardiology fellowship, Laxmi S. Mehta, MD, Ohio State University, Columbus, and colleagues wrote in an accompanying editorial.
The findings from the survey “reveal restrictive maternity leave data in a profession that has historically and currently continues to have a diversity problem,” they wrote.
“Maternity and pregnancy issues are a thing in cardiology,” Dr. Mehta said in an interview. “It’s one of the reasons why women get deterred from going into the field. It makes it challenging to choose cardiology if you perceive that the culture is negative, that it’s hard to be pregnant, or to bear children, or to take care of them post partum. It is problematic and it should not be occurring now.”
Leadership that condones such restrictive policies or even promotes them through ignorance and inaction needs to be held accountable, she added.
“We need to move forward from this negativity and make it more warm and welcoming to have families, whether you are a trainee or a practicing cardiologist, male or female. We need transparent and consistent parental leave policies and things like lactation support when a woman returns to work. That is a big issue,” Dr. Mehta said.
Having cardiovascular leaders champion the cause of adequate maternity and paternity leave are crucial to creating a newer, inclusive environment in cardiology.
As an example, Dr. Mehta recounted her own experience when she was in training 17 years ago.
“When I interviewed for a cardiology fellowship, one of the female program directors asked me if I was planning to have children, because if I did, the other fellows wouldn’t like it if they had to cover for me,” she said. “I ended up doing my fellowship where the chief of cardiology encouraged me to have children. He said: ‘Have your children during training, we will support you.’ And he did. I still had to do all of the call make-up and that stuff, but I worked in a supportive environment, and it made all the difference.”
“It’s about allyship,” she added. “You will have some people who are supportive and some who are not, but when you have the chief supporting you, you have a strong ally.”
The researchers suggest that one strategy is to temporarily replace cardiologists on maternity leave with locums, or “deepen the bench of coverage for clinical work, as is done for other absences. Given the expanding coverage of parental and family medical leaves, and awareness of these issues nationally, the need for this is likely to become less of an exception and more the rule.”
For example, nine states and Washington, D.C. now provide paid parental leave, they wrote, “and there is pending legislation in others.”
Dr. Bairey Merz and Dr. Mehta reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM THE JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY
Insurance mandates drive genetic testing and sex selection in IVF
The use of preimplantation genetic tests (PGT) in in vitro fertilization cycles, including tests for nonmedical sex selection, increased significantly in states without mandated insurance coverage, based on data from a study of 300,000 IVF cycles.
Previous studies have shown associations between IVF insurance coverage and various IVF practice patterns, but trends in genetic testing according to state-mandated insurance have not been explored, Bronwyn S. Bedrick, MD, of Johns Hopkins University, Baltimore, and colleagues wrote.
“Preimplantation genetic testing was introduced into clinical practice to prevent transmission of genetic disease and to improve uptake of single embryo transfer, but in the real world there are many potential applications,” corresponding author Emily Jungheim, MD, of Northwestern University, Chicago, said in an interview. “We wanted to know how PGT is being applied given that its use is on the rise.”
In a study published in Obstetrics & Gynecology, the researchers analyzed genetic testing in deidentified autologous, nonbanking IVF cycles from 2014 to 2016 obtained through the Society for Assisted Reproductive Technology Clinic Outcome Reporting System (SART CORS). The data set included 301,465 IVF cycles and 224,235 unique patients over the 3-year study period. Of these, 78,578 cycles (26%) used PGT, and overall, the proportion of IVF cycles using PGT approximately doubled, from 17% in 2014 to 34% in 2016 – a significant increase over time (risk ratio, 1.37). As of 2021, 13 states had mandates that health insurance include IVF costs.
In states with insurance mandates versus nonmandated states, the proportion of any PGT was 28.8% vs. 19.6%, and the probability was 32% lower in states with mandates (RR. 0.68; P < .001).
Aneuploidy was the most common indication for PGT, and accounted for 60% of the cycles; however, the number of cycles using PGT for elective sex selection increased from 1,314 cycles in 2014 to 2,184 in 2016 (approximately 66% increase).
In a multivariate analysis, IVF cycles for elective sex selection was 56% lower in states with mandates, compared with those without (RR, 0.44; P < .001).
In addition, cycles involving nonmedical sex selection were significantly more likely to result in male offspring, the researchers said.
“The increase in the number of cycles using elective sex selection seen in this study may reflect the growing number of clinics offering [PGT] for nonmedical sex selection as well as increasing public awareness of preimplantation genetic testing,” the researchers wrote.
However, the socioeconomic characteristics of women may play a role in the use of PGT, as those living in states with no mandate must be able pay the cost of IVF procedures, as well as the cost of PGT if desired, they noted.
“Because fertility centers may offer patients the choice to select the sex of their embryo after preimplantation genetic testing, this may in effect permit elective sex selection,” the researchers said. The shift in the male-female sex ratio in these cases “is concerning given the implications for future social demographics as IVF and preimplantation genetic testing utilization increase, and the negative effect outcomes could have on medical insurance policy and allocation of resources for medically indicated IVF and preimplantation genetic testing.”
The study findings were limited by several factors including the lack of clinic identifiers and lack of data characteristics including, race, ethnicity, and previous live births, the researchers noted. Other limitations included a lack of data on the sex preferences of the couple, and whether the sex of the embryo was known, and whether male and female embryos were transferred. Also, no states have mandates to cover PGT, and the limited study period may not generalize to current practices.
However, the study strengths include the large size and comprehensive database, and have implications for future policies and expansion of insurance coverage for infertility treatment and for preventing transmission of genetic diseases, they said.
Be mindful of consequences of testing
In an interview, Dr. Jungheim said she was surprised by some of the findings. “I thought we would see that PGT-A utilization was lower in states without mandates given the already high cost of IVF for patients paying out of pocket. I was also surprised to see that more males were born after PGT-A; it suggests that overall, patients using PGT-A favor males.
“For clinicians, we need to be mindful of the long-term impact of our practices,” she emphasized. “Shifting the sex ratio in favor of one sex or the other is an unintended consequence of IVF with PGT-A that can have negative implications for future generations.”
In the study, the researchers proposed a revision to the American Society for Reproductive Medicine Ethics Committee opinion on sex selection to provide guidance in keeping with ASRM’s mission of “accessible, ethical, and quality reproductive care for every person.”
However, “even if the ASRM Ethics Committee Opinion was revised, it’s up to clinicians to decide what they are comfortable with,” said Dr. Jungheim. “When patients are paying out of pocket for expensive treatments that require emotional investment and time, it can be difficult to keep medical decision making strictly evidence based.” Improved insurance coverage and access to fertility care may help with some of these decisions, but more real-world evidence is needed.
Let’s talk about sex (selection)
The study findings are both “novel and sobering,” and enhance the current body of evidence of associations between state insurance mandates and IVF outcomes, Jennifer Eaton, MD, of Brown University, Providence, R.I., wrote in an accompanying editorial.
“The association between mandate status and elective sex selection is particularly eye-opening,” said Dr. Eaton. The overall increased use of PGT for sex selection does not account for sex selection as part of testing for aneuploidy. In fact, “patients with euploid embryos of both sexes are frequently given the opportunity to select which embryo to transfer.”
The current study provides “compelling evidence that it is time to revisit the ethical dilemma of elective sex selection in the United States,” Dr. Eaton emphasized. The current ASRM guidance states that IVF clinics are not obligated to provide or refuse to provide nonmedically indicated methods of sex selection, but in light of the current study and other studies, a revision to the existing ASRM Ethics Committee opinion is needed.
The study received no outside funding. Neither the researchers nor Dr. Eaton had any financial conflicts to disclose.
The use of preimplantation genetic tests (PGT) in in vitro fertilization cycles, including tests for nonmedical sex selection, increased significantly in states without mandated insurance coverage, based on data from a study of 300,000 IVF cycles.
Previous studies have shown associations between IVF insurance coverage and various IVF practice patterns, but trends in genetic testing according to state-mandated insurance have not been explored, Bronwyn S. Bedrick, MD, of Johns Hopkins University, Baltimore, and colleagues wrote.
“Preimplantation genetic testing was introduced into clinical practice to prevent transmission of genetic disease and to improve uptake of single embryo transfer, but in the real world there are many potential applications,” corresponding author Emily Jungheim, MD, of Northwestern University, Chicago, said in an interview. “We wanted to know how PGT is being applied given that its use is on the rise.”
In a study published in Obstetrics & Gynecology, the researchers analyzed genetic testing in deidentified autologous, nonbanking IVF cycles from 2014 to 2016 obtained through the Society for Assisted Reproductive Technology Clinic Outcome Reporting System (SART CORS). The data set included 301,465 IVF cycles and 224,235 unique patients over the 3-year study period. Of these, 78,578 cycles (26%) used PGT, and overall, the proportion of IVF cycles using PGT approximately doubled, from 17% in 2014 to 34% in 2016 – a significant increase over time (risk ratio, 1.37). As of 2021, 13 states had mandates that health insurance include IVF costs.
In states with insurance mandates versus nonmandated states, the proportion of any PGT was 28.8% vs. 19.6%, and the probability was 32% lower in states with mandates (RR. 0.68; P < .001).
Aneuploidy was the most common indication for PGT, and accounted for 60% of the cycles; however, the number of cycles using PGT for elective sex selection increased from 1,314 cycles in 2014 to 2,184 in 2016 (approximately 66% increase).
In a multivariate analysis, IVF cycles for elective sex selection was 56% lower in states with mandates, compared with those without (RR, 0.44; P < .001).
In addition, cycles involving nonmedical sex selection were significantly more likely to result in male offspring, the researchers said.
“The increase in the number of cycles using elective sex selection seen in this study may reflect the growing number of clinics offering [PGT] for nonmedical sex selection as well as increasing public awareness of preimplantation genetic testing,” the researchers wrote.
However, the socioeconomic characteristics of women may play a role in the use of PGT, as those living in states with no mandate must be able pay the cost of IVF procedures, as well as the cost of PGT if desired, they noted.
“Because fertility centers may offer patients the choice to select the sex of their embryo after preimplantation genetic testing, this may in effect permit elective sex selection,” the researchers said. The shift in the male-female sex ratio in these cases “is concerning given the implications for future social demographics as IVF and preimplantation genetic testing utilization increase, and the negative effect outcomes could have on medical insurance policy and allocation of resources for medically indicated IVF and preimplantation genetic testing.”
The study findings were limited by several factors including the lack of clinic identifiers and lack of data characteristics including, race, ethnicity, and previous live births, the researchers noted. Other limitations included a lack of data on the sex preferences of the couple, and whether the sex of the embryo was known, and whether male and female embryos were transferred. Also, no states have mandates to cover PGT, and the limited study period may not generalize to current practices.
However, the study strengths include the large size and comprehensive database, and have implications for future policies and expansion of insurance coverage for infertility treatment and for preventing transmission of genetic diseases, they said.
Be mindful of consequences of testing
In an interview, Dr. Jungheim said she was surprised by some of the findings. “I thought we would see that PGT-A utilization was lower in states without mandates given the already high cost of IVF for patients paying out of pocket. I was also surprised to see that more males were born after PGT-A; it suggests that overall, patients using PGT-A favor males.
“For clinicians, we need to be mindful of the long-term impact of our practices,” she emphasized. “Shifting the sex ratio in favor of one sex or the other is an unintended consequence of IVF with PGT-A that can have negative implications for future generations.”
In the study, the researchers proposed a revision to the American Society for Reproductive Medicine Ethics Committee opinion on sex selection to provide guidance in keeping with ASRM’s mission of “accessible, ethical, and quality reproductive care for every person.”
However, “even if the ASRM Ethics Committee Opinion was revised, it’s up to clinicians to decide what they are comfortable with,” said Dr. Jungheim. “When patients are paying out of pocket for expensive treatments that require emotional investment and time, it can be difficult to keep medical decision making strictly evidence based.” Improved insurance coverage and access to fertility care may help with some of these decisions, but more real-world evidence is needed.
Let’s talk about sex (selection)
The study findings are both “novel and sobering,” and enhance the current body of evidence of associations between state insurance mandates and IVF outcomes, Jennifer Eaton, MD, of Brown University, Providence, R.I., wrote in an accompanying editorial.
“The association between mandate status and elective sex selection is particularly eye-opening,” said Dr. Eaton. The overall increased use of PGT for sex selection does not account for sex selection as part of testing for aneuploidy. In fact, “patients with euploid embryos of both sexes are frequently given the opportunity to select which embryo to transfer.”
The current study provides “compelling evidence that it is time to revisit the ethical dilemma of elective sex selection in the United States,” Dr. Eaton emphasized. The current ASRM guidance states that IVF clinics are not obligated to provide or refuse to provide nonmedically indicated methods of sex selection, but in light of the current study and other studies, a revision to the existing ASRM Ethics Committee opinion is needed.
The study received no outside funding. Neither the researchers nor Dr. Eaton had any financial conflicts to disclose.
The use of preimplantation genetic tests (PGT) in in vitro fertilization cycles, including tests for nonmedical sex selection, increased significantly in states without mandated insurance coverage, based on data from a study of 300,000 IVF cycles.
Previous studies have shown associations between IVF insurance coverage and various IVF practice patterns, but trends in genetic testing according to state-mandated insurance have not been explored, Bronwyn S. Bedrick, MD, of Johns Hopkins University, Baltimore, and colleagues wrote.
“Preimplantation genetic testing was introduced into clinical practice to prevent transmission of genetic disease and to improve uptake of single embryo transfer, but in the real world there are many potential applications,” corresponding author Emily Jungheim, MD, of Northwestern University, Chicago, said in an interview. “We wanted to know how PGT is being applied given that its use is on the rise.”
In a study published in Obstetrics & Gynecology, the researchers analyzed genetic testing in deidentified autologous, nonbanking IVF cycles from 2014 to 2016 obtained through the Society for Assisted Reproductive Technology Clinic Outcome Reporting System (SART CORS). The data set included 301,465 IVF cycles and 224,235 unique patients over the 3-year study period. Of these, 78,578 cycles (26%) used PGT, and overall, the proportion of IVF cycles using PGT approximately doubled, from 17% in 2014 to 34% in 2016 – a significant increase over time (risk ratio, 1.37). As of 2021, 13 states had mandates that health insurance include IVF costs.
In states with insurance mandates versus nonmandated states, the proportion of any PGT was 28.8% vs. 19.6%, and the probability was 32% lower in states with mandates (RR. 0.68; P < .001).
Aneuploidy was the most common indication for PGT, and accounted for 60% of the cycles; however, the number of cycles using PGT for elective sex selection increased from 1,314 cycles in 2014 to 2,184 in 2016 (approximately 66% increase).
In a multivariate analysis, IVF cycles for elective sex selection was 56% lower in states with mandates, compared with those without (RR, 0.44; P < .001).
In addition, cycles involving nonmedical sex selection were significantly more likely to result in male offspring, the researchers said.
“The increase in the number of cycles using elective sex selection seen in this study may reflect the growing number of clinics offering [PGT] for nonmedical sex selection as well as increasing public awareness of preimplantation genetic testing,” the researchers wrote.
However, the socioeconomic characteristics of women may play a role in the use of PGT, as those living in states with no mandate must be able pay the cost of IVF procedures, as well as the cost of PGT if desired, they noted.
“Because fertility centers may offer patients the choice to select the sex of their embryo after preimplantation genetic testing, this may in effect permit elective sex selection,” the researchers said. The shift in the male-female sex ratio in these cases “is concerning given the implications for future social demographics as IVF and preimplantation genetic testing utilization increase, and the negative effect outcomes could have on medical insurance policy and allocation of resources for medically indicated IVF and preimplantation genetic testing.”
The study findings were limited by several factors including the lack of clinic identifiers and lack of data characteristics including, race, ethnicity, and previous live births, the researchers noted. Other limitations included a lack of data on the sex preferences of the couple, and whether the sex of the embryo was known, and whether male and female embryos were transferred. Also, no states have mandates to cover PGT, and the limited study period may not generalize to current practices.
However, the study strengths include the large size and comprehensive database, and have implications for future policies and expansion of insurance coverage for infertility treatment and for preventing transmission of genetic diseases, they said.
Be mindful of consequences of testing
In an interview, Dr. Jungheim said she was surprised by some of the findings. “I thought we would see that PGT-A utilization was lower in states without mandates given the already high cost of IVF for patients paying out of pocket. I was also surprised to see that more males were born after PGT-A; it suggests that overall, patients using PGT-A favor males.
“For clinicians, we need to be mindful of the long-term impact of our practices,” she emphasized. “Shifting the sex ratio in favor of one sex or the other is an unintended consequence of IVF with PGT-A that can have negative implications for future generations.”
In the study, the researchers proposed a revision to the American Society for Reproductive Medicine Ethics Committee opinion on sex selection to provide guidance in keeping with ASRM’s mission of “accessible, ethical, and quality reproductive care for every person.”
However, “even if the ASRM Ethics Committee Opinion was revised, it’s up to clinicians to decide what they are comfortable with,” said Dr. Jungheim. “When patients are paying out of pocket for expensive treatments that require emotional investment and time, it can be difficult to keep medical decision making strictly evidence based.” Improved insurance coverage and access to fertility care may help with some of these decisions, but more real-world evidence is needed.
Let’s talk about sex (selection)
The study findings are both “novel and sobering,” and enhance the current body of evidence of associations between state insurance mandates and IVF outcomes, Jennifer Eaton, MD, of Brown University, Providence, R.I., wrote in an accompanying editorial.
“The association between mandate status and elective sex selection is particularly eye-opening,” said Dr. Eaton. The overall increased use of PGT for sex selection does not account for sex selection as part of testing for aneuploidy. In fact, “patients with euploid embryos of both sexes are frequently given the opportunity to select which embryo to transfer.”
The current study provides “compelling evidence that it is time to revisit the ethical dilemma of elective sex selection in the United States,” Dr. Eaton emphasized. The current ASRM guidance states that IVF clinics are not obligated to provide or refuse to provide nonmedically indicated methods of sex selection, but in light of the current study and other studies, a revision to the existing ASRM Ethics Committee opinion is needed.
The study received no outside funding. Neither the researchers nor Dr. Eaton had any financial conflicts to disclose.
FROM OBSTETRICS & GYNECOLOGY
Study: Majority of research on homeopathic remedies unpublished or unregistered
Homeopathy is a form of alternative medicine based on the concept that increasing dilution of a substance leads to a stronger treatment effect.
The authors of the new paper, published in BMJ Evidence-Based Medicine, also found that a quarter of the 90 randomized published trials on homeopathic remedies they analyzed changed their results before publication.
The benefits of homeopathy touted in studies may be greatly exaggerated, suggest the authors, Gerald Gartlehner, MD, of Danube University, Krems, Austria, and colleagues.
The results raise awareness that published homeopathy trials represent a limited proportion of research, skewed toward favorable results, they wrote.
“This likely affects the validity of the body of evidence of homeopathic literature and may substantially overestimate the true treatment effect of homeopathic remedies,” they concluded.
Homeopathy as practiced today was developed approximately 200 years ago in Germany, and despite ongoing debate about its effectiveness, it remains a popular alternative to conventional medicine in many developed countries, the authors noted.
According to the National Institutes of Health, homeopathy is based on the idea of “like cures like,” meaning that a disease can be cured with a substance that produces similar symptoms in healthy people, and the “law of minimum dose,” meaning that a lower dose of medication will be more effective. “Many homeopathic products are so diluted that no molecules of the original substance remain,” according to the NIH.
Homeopathy is not subject to most regulatory requirements, so assessment of effectiveness of homeopathic remedies is limited to published data, the researchers said. “When no information is publicly available about the majority of homeopathic trials, sound conclusions about the efficacy and the risks of using homeopathic medicinal products for treating health conditions are impossible,” they wrote.
Study methods and findings
The researchers examined 17 trial registries for studies involving homeopathic remedies conducted since 2002.
The registries included clinicaltrials.gov, the EU Clinical Trials Register, and the International Clinical Trials Registry Platform up to April 2019 to identify registered homeopathy trials.
To determine whether registered trials were published and to identify trials that were published but unregistered, the researchers examined PubMed, the Allied and Complementary Medicine Database, Embase, and Google Scholar up to April 2021.
They found that approximately 38% of registered trials of homeopathy were never published, and 53% of the published randomized, controlled trials (RCTs) were not registered. Notably, 25% of the trials that were registered and published showed primary outcomes that were changed compared with the registry.
The number of registered homeopathy trials increased significantly over the past 5 years, but approximately one-third (30%) of trials published during the last 5 years were not registered, they said. In a meta-analysis, unregistered RCTs showed significantly greater treatment effects than registered RCTs, with standardized mean differences of –0.53 and –0.14, respectively.
The study findings were limited by several factors including the potential for missed records of studies not covered by the registries searched. Other limitations include the analysis of pooled data from homeopathic treatments that may not generalize to personalized homeopathy, and the exclusion of trials labeled as terminated or suspended.
Proceed with caution before recommending use of homeopathic remedies, says expert
Linda Girgis, MD, noted that prior to reading this report she had known that most homeopathic remedies didn’t have any evidence of being effective, and that, therefore, the results validated her understanding of the findings of studies of homeopathy.
The study is especially important at this time in the wake of the COVID-19 pandemic, Dr. Girgis, a family physician in private practice in South River, N.J., said in an interview.
“Many people are promoting treatments that don’t have any evidence that they are effective, and more people are turning to homeopathic treatments not knowing the risks and assuming they are safe,” she continued. “Many people are taking advantage of this and trying to cash in on this with ill-proven remedies.”
Homeopathic remedies become especially harmful when patients think they can use them instead of traditional medicine, she added.
Noting that some homeopathic remedies have been studied and show some evidence that they work, Dr. Girgis said there may be a role for certain ones in primary care.
“An example would be black cohosh or primrose oil for perimenopausal hot flashes. This could be a good alternative when you want to avoid hormonal supplements,” she said.
At the same time, Dr. Girgis advised clinicians to be cautious about suggesting homeopathic remedies to patients.
“Homeopathy seems to be a good money maker if you sell these products. However, you are not protected from liability and can be found more liable for prescribing off-label treatments or those not [Food and Drug Administration] approved,” Dr. Girgis said. Her general message to clinicians: Stick with evidence-based medicine.
Her message to patients who might want to pursue homeopathic remedies is that just because something is “homeopathic” or natural doesn’t mean that it is safe.
“There are some [homeopathic] products that have caused liver damage or other problems,” she explained. “Also, these remedies can interact with other medications.”
The study received no outside funding. The researchers and Dr. Girgis had no financial conflicts to disclose.
Homeopathy is a form of alternative medicine based on the concept that increasing dilution of a substance leads to a stronger treatment effect.
The authors of the new paper, published in BMJ Evidence-Based Medicine, also found that a quarter of the 90 randomized published trials on homeopathic remedies they analyzed changed their results before publication.
The benefits of homeopathy touted in studies may be greatly exaggerated, suggest the authors, Gerald Gartlehner, MD, of Danube University, Krems, Austria, and colleagues.
The results raise awareness that published homeopathy trials represent a limited proportion of research, skewed toward favorable results, they wrote.
“This likely affects the validity of the body of evidence of homeopathic literature and may substantially overestimate the true treatment effect of homeopathic remedies,” they concluded.
Homeopathy as practiced today was developed approximately 200 years ago in Germany, and despite ongoing debate about its effectiveness, it remains a popular alternative to conventional medicine in many developed countries, the authors noted.
According to the National Institutes of Health, homeopathy is based on the idea of “like cures like,” meaning that a disease can be cured with a substance that produces similar symptoms in healthy people, and the “law of minimum dose,” meaning that a lower dose of medication will be more effective. “Many homeopathic products are so diluted that no molecules of the original substance remain,” according to the NIH.
Homeopathy is not subject to most regulatory requirements, so assessment of effectiveness of homeopathic remedies is limited to published data, the researchers said. “When no information is publicly available about the majority of homeopathic trials, sound conclusions about the efficacy and the risks of using homeopathic medicinal products for treating health conditions are impossible,” they wrote.
Study methods and findings
The researchers examined 17 trial registries for studies involving homeopathic remedies conducted since 2002.
The registries included clinicaltrials.gov, the EU Clinical Trials Register, and the International Clinical Trials Registry Platform up to April 2019 to identify registered homeopathy trials.
To determine whether registered trials were published and to identify trials that were published but unregistered, the researchers examined PubMed, the Allied and Complementary Medicine Database, Embase, and Google Scholar up to April 2021.
They found that approximately 38% of registered trials of homeopathy were never published, and 53% of the published randomized, controlled trials (RCTs) were not registered. Notably, 25% of the trials that were registered and published showed primary outcomes that were changed compared with the registry.
The number of registered homeopathy trials increased significantly over the past 5 years, but approximately one-third (30%) of trials published during the last 5 years were not registered, they said. In a meta-analysis, unregistered RCTs showed significantly greater treatment effects than registered RCTs, with standardized mean differences of –0.53 and –0.14, respectively.
The study findings were limited by several factors including the potential for missed records of studies not covered by the registries searched. Other limitations include the analysis of pooled data from homeopathic treatments that may not generalize to personalized homeopathy, and the exclusion of trials labeled as terminated or suspended.
Proceed with caution before recommending use of homeopathic remedies, says expert
Linda Girgis, MD, noted that prior to reading this report she had known that most homeopathic remedies didn’t have any evidence of being effective, and that, therefore, the results validated her understanding of the findings of studies of homeopathy.
The study is especially important at this time in the wake of the COVID-19 pandemic, Dr. Girgis, a family physician in private practice in South River, N.J., said in an interview.
“Many people are promoting treatments that don’t have any evidence that they are effective, and more people are turning to homeopathic treatments not knowing the risks and assuming they are safe,” she continued. “Many people are taking advantage of this and trying to cash in on this with ill-proven remedies.”
Homeopathic remedies become especially harmful when patients think they can use them instead of traditional medicine, she added.
Noting that some homeopathic remedies have been studied and show some evidence that they work, Dr. Girgis said there may be a role for certain ones in primary care.
“An example would be black cohosh or primrose oil for perimenopausal hot flashes. This could be a good alternative when you want to avoid hormonal supplements,” she said.
At the same time, Dr. Girgis advised clinicians to be cautious about suggesting homeopathic remedies to patients.
“Homeopathy seems to be a good money maker if you sell these products. However, you are not protected from liability and can be found more liable for prescribing off-label treatments or those not [Food and Drug Administration] approved,” Dr. Girgis said. Her general message to clinicians: Stick with evidence-based medicine.
Her message to patients who might want to pursue homeopathic remedies is that just because something is “homeopathic” or natural doesn’t mean that it is safe.
“There are some [homeopathic] products that have caused liver damage or other problems,” she explained. “Also, these remedies can interact with other medications.”
The study received no outside funding. The researchers and Dr. Girgis had no financial conflicts to disclose.
Homeopathy is a form of alternative medicine based on the concept that increasing dilution of a substance leads to a stronger treatment effect.
The authors of the new paper, published in BMJ Evidence-Based Medicine, also found that a quarter of the 90 randomized published trials on homeopathic remedies they analyzed changed their results before publication.
The benefits of homeopathy touted in studies may be greatly exaggerated, suggest the authors, Gerald Gartlehner, MD, of Danube University, Krems, Austria, and colleagues.
The results raise awareness that published homeopathy trials represent a limited proportion of research, skewed toward favorable results, they wrote.
“This likely affects the validity of the body of evidence of homeopathic literature and may substantially overestimate the true treatment effect of homeopathic remedies,” they concluded.
Homeopathy as practiced today was developed approximately 200 years ago in Germany, and despite ongoing debate about its effectiveness, it remains a popular alternative to conventional medicine in many developed countries, the authors noted.
According to the National Institutes of Health, homeopathy is based on the idea of “like cures like,” meaning that a disease can be cured with a substance that produces similar symptoms in healthy people, and the “law of minimum dose,” meaning that a lower dose of medication will be more effective. “Many homeopathic products are so diluted that no molecules of the original substance remain,” according to the NIH.
Homeopathy is not subject to most regulatory requirements, so assessment of effectiveness of homeopathic remedies is limited to published data, the researchers said. “When no information is publicly available about the majority of homeopathic trials, sound conclusions about the efficacy and the risks of using homeopathic medicinal products for treating health conditions are impossible,” they wrote.
Study methods and findings
The researchers examined 17 trial registries for studies involving homeopathic remedies conducted since 2002.
The registries included clinicaltrials.gov, the EU Clinical Trials Register, and the International Clinical Trials Registry Platform up to April 2019 to identify registered homeopathy trials.
To determine whether registered trials were published and to identify trials that were published but unregistered, the researchers examined PubMed, the Allied and Complementary Medicine Database, Embase, and Google Scholar up to April 2021.
They found that approximately 38% of registered trials of homeopathy were never published, and 53% of the published randomized, controlled trials (RCTs) were not registered. Notably, 25% of the trials that were registered and published showed primary outcomes that were changed compared with the registry.
The number of registered homeopathy trials increased significantly over the past 5 years, but approximately one-third (30%) of trials published during the last 5 years were not registered, they said. In a meta-analysis, unregistered RCTs showed significantly greater treatment effects than registered RCTs, with standardized mean differences of –0.53 and –0.14, respectively.
The study findings were limited by several factors including the potential for missed records of studies not covered by the registries searched. Other limitations include the analysis of pooled data from homeopathic treatments that may not generalize to personalized homeopathy, and the exclusion of trials labeled as terminated or suspended.
Proceed with caution before recommending use of homeopathic remedies, says expert
Linda Girgis, MD, noted that prior to reading this report she had known that most homeopathic remedies didn’t have any evidence of being effective, and that, therefore, the results validated her understanding of the findings of studies of homeopathy.
The study is especially important at this time in the wake of the COVID-19 pandemic, Dr. Girgis, a family physician in private practice in South River, N.J., said in an interview.
“Many people are promoting treatments that don’t have any evidence that they are effective, and more people are turning to homeopathic treatments not knowing the risks and assuming they are safe,” she continued. “Many people are taking advantage of this and trying to cash in on this with ill-proven remedies.”
Homeopathic remedies become especially harmful when patients think they can use them instead of traditional medicine, she added.
Noting that some homeopathic remedies have been studied and show some evidence that they work, Dr. Girgis said there may be a role for certain ones in primary care.
“An example would be black cohosh or primrose oil for perimenopausal hot flashes. This could be a good alternative when you want to avoid hormonal supplements,” she said.
At the same time, Dr. Girgis advised clinicians to be cautious about suggesting homeopathic remedies to patients.
“Homeopathy seems to be a good money maker if you sell these products. However, you are not protected from liability and can be found more liable for prescribing off-label treatments or those not [Food and Drug Administration] approved,” Dr. Girgis said. Her general message to clinicians: Stick with evidence-based medicine.
Her message to patients who might want to pursue homeopathic remedies is that just because something is “homeopathic” or natural doesn’t mean that it is safe.
“There are some [homeopathic] products that have caused liver damage or other problems,” she explained. “Also, these remedies can interact with other medications.”
The study received no outside funding. The researchers and Dr. Girgis had no financial conflicts to disclose.
FROM BMJ EVIDENCE BASED MEDICINE
Genomic analysis reveals possible role of AMH in PCOS infertility
A genomic study has revealed new insights into the function of anti-Müllerian hormone (AMH) in the context of reproductive biology and fertility.
Insights into the physiological, and potentially therapeutic, function were identified based on data from single-cell RNA sequencing, derived from transcriptomic analysis and immunolabeling of antral follicles.
“The specific contribution of elevated AMH to the molecular pathology of polycystic ovary syndrome (PCOS) and its defining clinical features is unclear, as no study, to date, has examined the effect of chronically elevated AMH in an experimentally controlled in vivo model,” study author Limor Man, MD, of Weill Cornell Medicine, New York, and colleagues wrote. The group’s findings were published in Science Advances.
The researchers used ovarian cortical xenografts with cotransplantation of engineered endothelial cells to examine the effect of chronic paracrine AMH stimulus on human folliculogenesis.
They cotransplanted human ovarian cortex with control or AMH-expressing endothelial cells in immunocompromised mice and recovered antral follicles for purification and subsequent analysis. Overall, 38 antral follicles were observed (19 control and 19 AMH) at long-term intervals, defined as intervals greater than 10 weeks.
The researchers found that long-term xenografts showed an accelerated growth rate in the setting of chronically elevated AMH and exhibited a molecular signature indicative of more advanced stages of follicle maturation, including that of luteinization.
In mice, exogenous AMH follicles showed a decreased ratio of primordial to growing follicles and antral follicles of increased diameter.
In addition, transcriptomic and immunolabeling analyses revealed that chronic high AMH had a marked influence on the growth and transcriptomic signature of antral-stage follicles, with a universal increase in factors related to the synthesis and/or metabolism of cholesterol and sex steroid hormones, as well as early expression of factors often seen at later stages of folliculogenesis.
“These data decouple elevated AMH from the metabolic and hyperandrogenic conditions that define PCOS and suggest that chronically elevated AMH induces a molecular cascade that contributes, at least in part, to the anovulatory phenotype in these patients,” the researchers wrote.
Furthermore, they found evidence to suggest that chronic high AMH can induce expression of the luteinizing hormone receptor at earlier stages of folliculogenesis, thereby worsening the disruptive effect of elevated luteinizing hormone from the pituitary.
“[These] findings underscore the broad influence of AMH on transcriptional activity and maturation state of follicles and support an independent role for dysregulation of AMH signaling in driving anovulation in women with PCOS,” they wrote.
While these findings are intriguing, the researchers cautioned against drawing conclusions from the study since elevated AMH is almost always seen in combination with one or more symptomatic hallmarks in PCOS.
“Despite [some] limitations, [our] analysis provides a deep and high-resolution examination of AMH action on human folliculogenesis and suggests a prominent effect on antral follicle maturation,” they explained.
Expert perspective
“From age 25, AMH levels begin their decline until reaching undetectable levels at menopause,” Mark P. Trolice, MD, director of the IVF Center in Winter Park, Fla., and professor of obstetrics and gynecology at the University of Central Florida, Orlando, said in an interview. “Women with PCOS experience a chronic and frustrating pathophysiologic problem whose origins and mechanism have evaded researchers for decades.
“As AMH elevations in utero may contribute to fetal susceptibility to PCOS, this study provides another potential link by suggesting that chronically elevated AMH induces anovulation,” he added. “We await, with great anticipation, future clinical studies to potentially further illustrate the apparent and intriguing role of AMH in the development of PCOS.”
This study was supported by the Queenie Victorina Neri Scholarship and a Research Grant from the American Society for Reproductive Medicine. One author reported financial relationships with Oviva Therapeutics; no other conflicts of interest were reported.
A genomic study has revealed new insights into the function of anti-Müllerian hormone (AMH) in the context of reproductive biology and fertility.
Insights into the physiological, and potentially therapeutic, function were identified based on data from single-cell RNA sequencing, derived from transcriptomic analysis and immunolabeling of antral follicles.
“The specific contribution of elevated AMH to the molecular pathology of polycystic ovary syndrome (PCOS) and its defining clinical features is unclear, as no study, to date, has examined the effect of chronically elevated AMH in an experimentally controlled in vivo model,” study author Limor Man, MD, of Weill Cornell Medicine, New York, and colleagues wrote. The group’s findings were published in Science Advances.
The researchers used ovarian cortical xenografts with cotransplantation of engineered endothelial cells to examine the effect of chronic paracrine AMH stimulus on human folliculogenesis.
They cotransplanted human ovarian cortex with control or AMH-expressing endothelial cells in immunocompromised mice and recovered antral follicles for purification and subsequent analysis. Overall, 38 antral follicles were observed (19 control and 19 AMH) at long-term intervals, defined as intervals greater than 10 weeks.
The researchers found that long-term xenografts showed an accelerated growth rate in the setting of chronically elevated AMH and exhibited a molecular signature indicative of more advanced stages of follicle maturation, including that of luteinization.
In mice, exogenous AMH follicles showed a decreased ratio of primordial to growing follicles and antral follicles of increased diameter.
In addition, transcriptomic and immunolabeling analyses revealed that chronic high AMH had a marked influence on the growth and transcriptomic signature of antral-stage follicles, with a universal increase in factors related to the synthesis and/or metabolism of cholesterol and sex steroid hormones, as well as early expression of factors often seen at later stages of folliculogenesis.
“These data decouple elevated AMH from the metabolic and hyperandrogenic conditions that define PCOS and suggest that chronically elevated AMH induces a molecular cascade that contributes, at least in part, to the anovulatory phenotype in these patients,” the researchers wrote.
Furthermore, they found evidence to suggest that chronic high AMH can induce expression of the luteinizing hormone receptor at earlier stages of folliculogenesis, thereby worsening the disruptive effect of elevated luteinizing hormone from the pituitary.
“[These] findings underscore the broad influence of AMH on transcriptional activity and maturation state of follicles and support an independent role for dysregulation of AMH signaling in driving anovulation in women with PCOS,” they wrote.
While these findings are intriguing, the researchers cautioned against drawing conclusions from the study since elevated AMH is almost always seen in combination with one or more symptomatic hallmarks in PCOS.
“Despite [some] limitations, [our] analysis provides a deep and high-resolution examination of AMH action on human folliculogenesis and suggests a prominent effect on antral follicle maturation,” they explained.
Expert perspective
“From age 25, AMH levels begin their decline until reaching undetectable levels at menopause,” Mark P. Trolice, MD, director of the IVF Center in Winter Park, Fla., and professor of obstetrics and gynecology at the University of Central Florida, Orlando, said in an interview. “Women with PCOS experience a chronic and frustrating pathophysiologic problem whose origins and mechanism have evaded researchers for decades.
“As AMH elevations in utero may contribute to fetal susceptibility to PCOS, this study provides another potential link by suggesting that chronically elevated AMH induces anovulation,” he added. “We await, with great anticipation, future clinical studies to potentially further illustrate the apparent and intriguing role of AMH in the development of PCOS.”
This study was supported by the Queenie Victorina Neri Scholarship and a Research Grant from the American Society for Reproductive Medicine. One author reported financial relationships with Oviva Therapeutics; no other conflicts of interest were reported.
A genomic study has revealed new insights into the function of anti-Müllerian hormone (AMH) in the context of reproductive biology and fertility.
Insights into the physiological, and potentially therapeutic, function were identified based on data from single-cell RNA sequencing, derived from transcriptomic analysis and immunolabeling of antral follicles.
“The specific contribution of elevated AMH to the molecular pathology of polycystic ovary syndrome (PCOS) and its defining clinical features is unclear, as no study, to date, has examined the effect of chronically elevated AMH in an experimentally controlled in vivo model,” study author Limor Man, MD, of Weill Cornell Medicine, New York, and colleagues wrote. The group’s findings were published in Science Advances.
The researchers used ovarian cortical xenografts with cotransplantation of engineered endothelial cells to examine the effect of chronic paracrine AMH stimulus on human folliculogenesis.
They cotransplanted human ovarian cortex with control or AMH-expressing endothelial cells in immunocompromised mice and recovered antral follicles for purification and subsequent analysis. Overall, 38 antral follicles were observed (19 control and 19 AMH) at long-term intervals, defined as intervals greater than 10 weeks.
The researchers found that long-term xenografts showed an accelerated growth rate in the setting of chronically elevated AMH and exhibited a molecular signature indicative of more advanced stages of follicle maturation, including that of luteinization.
In mice, exogenous AMH follicles showed a decreased ratio of primordial to growing follicles and antral follicles of increased diameter.
In addition, transcriptomic and immunolabeling analyses revealed that chronic high AMH had a marked influence on the growth and transcriptomic signature of antral-stage follicles, with a universal increase in factors related to the synthesis and/or metabolism of cholesterol and sex steroid hormones, as well as early expression of factors often seen at later stages of folliculogenesis.
“These data decouple elevated AMH from the metabolic and hyperandrogenic conditions that define PCOS and suggest that chronically elevated AMH induces a molecular cascade that contributes, at least in part, to the anovulatory phenotype in these patients,” the researchers wrote.
Furthermore, they found evidence to suggest that chronic high AMH can induce expression of the luteinizing hormone receptor at earlier stages of folliculogenesis, thereby worsening the disruptive effect of elevated luteinizing hormone from the pituitary.
“[These] findings underscore the broad influence of AMH on transcriptional activity and maturation state of follicles and support an independent role for dysregulation of AMH signaling in driving anovulation in women with PCOS,” they wrote.
While these findings are intriguing, the researchers cautioned against drawing conclusions from the study since elevated AMH is almost always seen in combination with one or more symptomatic hallmarks in PCOS.
“Despite [some] limitations, [our] analysis provides a deep and high-resolution examination of AMH action on human folliculogenesis and suggests a prominent effect on antral follicle maturation,” they explained.
Expert perspective
“From age 25, AMH levels begin their decline until reaching undetectable levels at menopause,” Mark P. Trolice, MD, director of the IVF Center in Winter Park, Fla., and professor of obstetrics and gynecology at the University of Central Florida, Orlando, said in an interview. “Women with PCOS experience a chronic and frustrating pathophysiologic problem whose origins and mechanism have evaded researchers for decades.
“As AMH elevations in utero may contribute to fetal susceptibility to PCOS, this study provides another potential link by suggesting that chronically elevated AMH induces anovulation,” he added. “We await, with great anticipation, future clinical studies to potentially further illustrate the apparent and intriguing role of AMH in the development of PCOS.”
This study was supported by the Queenie Victorina Neri Scholarship and a Research Grant from the American Society for Reproductive Medicine. One author reported financial relationships with Oviva Therapeutics; no other conflicts of interest were reported.
FROM SCIENCE ADVANCES
Selling your practice
My previous column on practice valuation prompted a number of questions on the mechanics of selling a private practice. As usual, I cannot hope to cover this complex topic comprehensively in only 750 words, but here are the basics.
A generation ago, the sale of a medical practice was much like the sale of any other business: A retiring physician would sell his or her practice to a young doctor and the practice would continue on as before. Occasionally, that still happens, but changes in the business of medicine – most significantly the growth of managed care – have had a big impact on the way medical practices are bought and sold.
For one thing, there are far fewer solo practitioners these days, and polls indicate that most young physicians intend to continue that trend.
.For another, because the rules governing such sales have become so numbingly complex, the services of expert (and expensive) third parties are essential.
While these issues may complicate matters, there is still a market for the sale of medical practices. However, you must do everything possible to ensure you identify the best possible buyer and structure the best deal.
The first hurdle is the accurate valuation of your practice, which was covered in some detail in my last column. Briefly, for the protection of both parties, it is important that the appraisal be done by an experienced and neutral financial consultant, that all techniques used in the valuation be divulged and explained, and that documentation be supplied to support the conclusions reached.
Keep in mind that the valuation will not necessarily equal the purchase price; other factors may need to be considered before a final price can be agreed upon. Keep in mind, too, that there may be legal constraints on the purchase price. For example, if the buyer is a nonprofit corporation such as a hospital or HMO, by law it cannot pay in excess of fair market value for the practice – which may rule out any valuation of “good will.” In some states, the purchase of private practices by hospitals is prohibited altogether – so you might need to consider a long-term lease rather than a sale.
Once a value has been agreed upon, you must consider how the transaction will be structured. The most popular structures include purchase of assets, purchase of corporate stock, and merger.
Many buyers prefer to purchase assets, because it allows them to pick and choose only those items that have value to them. This can leave you with a bunch of “odd lot” assets to dispose of. But depending on the circumstances, an asset sale may still be to your advantage.
Sellers typically prefer to sell stock, because it allows them to sell their entire practice, which is often worth more than the sum of its parts, and often provides tax advantages.
The third option, merger, continues to grow in popularity and is a column subject in itself, and I will address it separately next month.
Tax issues must always be considered. Most private practices are corporations, and the sale of corporate stock will result in a long-term capital gain that will be taxed – currently at 15%-20%. As the saying goes, it’s not what you earn, it’s what you keep. So it may benefit you to accept a slightly lower price if the sale can be structured to provide significantly lower tax treatment. However, any gain that does not qualify as a long-term capital gain will be taxed as regular income – currently in the 32%-37% percent range – plus a Social Security tax of about 15%.
Payment in installments is a popular way to defer taxes, since they are incurred on each installment as it is paid; but such payments may be mistaken by the IRS for payments for referrals, which is illegal. And there is always the problem of making certain all payments are eventually made.
You may wish to continue working at the practice as an employee for an agreed-upon period of time, and this is often to the buyer’s advantage as well. Transitioning to new ownership in stages often maximizes the value of the business by improving patient retention, and allows patients to become accustomed to the transition. However, care must be taken, with the aid of good legal advice, to structure such an arrangement in a way that minimizes concerns of fraud and abuse.
Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].
My previous column on practice valuation prompted a number of questions on the mechanics of selling a private practice. As usual, I cannot hope to cover this complex topic comprehensively in only 750 words, but here are the basics.
A generation ago, the sale of a medical practice was much like the sale of any other business: A retiring physician would sell his or her practice to a young doctor and the practice would continue on as before. Occasionally, that still happens, but changes in the business of medicine – most significantly the growth of managed care – have had a big impact on the way medical practices are bought and sold.
For one thing, there are far fewer solo practitioners these days, and polls indicate that most young physicians intend to continue that trend.
.For another, because the rules governing such sales have become so numbingly complex, the services of expert (and expensive) third parties are essential.
While these issues may complicate matters, there is still a market for the sale of medical practices. However, you must do everything possible to ensure you identify the best possible buyer and structure the best deal.
The first hurdle is the accurate valuation of your practice, which was covered in some detail in my last column. Briefly, for the protection of both parties, it is important that the appraisal be done by an experienced and neutral financial consultant, that all techniques used in the valuation be divulged and explained, and that documentation be supplied to support the conclusions reached.
Keep in mind that the valuation will not necessarily equal the purchase price; other factors may need to be considered before a final price can be agreed upon. Keep in mind, too, that there may be legal constraints on the purchase price. For example, if the buyer is a nonprofit corporation such as a hospital or HMO, by law it cannot pay in excess of fair market value for the practice – which may rule out any valuation of “good will.” In some states, the purchase of private practices by hospitals is prohibited altogether – so you might need to consider a long-term lease rather than a sale.
Once a value has been agreed upon, you must consider how the transaction will be structured. The most popular structures include purchase of assets, purchase of corporate stock, and merger.
Many buyers prefer to purchase assets, because it allows them to pick and choose only those items that have value to them. This can leave you with a bunch of “odd lot” assets to dispose of. But depending on the circumstances, an asset sale may still be to your advantage.
Sellers typically prefer to sell stock, because it allows them to sell their entire practice, which is often worth more than the sum of its parts, and often provides tax advantages.
The third option, merger, continues to grow in popularity and is a column subject in itself, and I will address it separately next month.
Tax issues must always be considered. Most private practices are corporations, and the sale of corporate stock will result in a long-term capital gain that will be taxed – currently at 15%-20%. As the saying goes, it’s not what you earn, it’s what you keep. So it may benefit you to accept a slightly lower price if the sale can be structured to provide significantly lower tax treatment. However, any gain that does not qualify as a long-term capital gain will be taxed as regular income – currently in the 32%-37% percent range – plus a Social Security tax of about 15%.
Payment in installments is a popular way to defer taxes, since they are incurred on each installment as it is paid; but such payments may be mistaken by the IRS for payments for referrals, which is illegal. And there is always the problem of making certain all payments are eventually made.
You may wish to continue working at the practice as an employee for an agreed-upon period of time, and this is often to the buyer’s advantage as well. Transitioning to new ownership in stages often maximizes the value of the business by improving patient retention, and allows patients to become accustomed to the transition. However, care must be taken, with the aid of good legal advice, to structure such an arrangement in a way that minimizes concerns of fraud and abuse.
Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].
My previous column on practice valuation prompted a number of questions on the mechanics of selling a private practice. As usual, I cannot hope to cover this complex topic comprehensively in only 750 words, but here are the basics.
A generation ago, the sale of a medical practice was much like the sale of any other business: A retiring physician would sell his or her practice to a young doctor and the practice would continue on as before. Occasionally, that still happens, but changes in the business of medicine – most significantly the growth of managed care – have had a big impact on the way medical practices are bought and sold.
For one thing, there are far fewer solo practitioners these days, and polls indicate that most young physicians intend to continue that trend.
.For another, because the rules governing such sales have become so numbingly complex, the services of expert (and expensive) third parties are essential.
While these issues may complicate matters, there is still a market for the sale of medical practices. However, you must do everything possible to ensure you identify the best possible buyer and structure the best deal.
The first hurdle is the accurate valuation of your practice, which was covered in some detail in my last column. Briefly, for the protection of both parties, it is important that the appraisal be done by an experienced and neutral financial consultant, that all techniques used in the valuation be divulged and explained, and that documentation be supplied to support the conclusions reached.
Keep in mind that the valuation will not necessarily equal the purchase price; other factors may need to be considered before a final price can be agreed upon. Keep in mind, too, that there may be legal constraints on the purchase price. For example, if the buyer is a nonprofit corporation such as a hospital or HMO, by law it cannot pay in excess of fair market value for the practice – which may rule out any valuation of “good will.” In some states, the purchase of private practices by hospitals is prohibited altogether – so you might need to consider a long-term lease rather than a sale.
Once a value has been agreed upon, you must consider how the transaction will be structured. The most popular structures include purchase of assets, purchase of corporate stock, and merger.
Many buyers prefer to purchase assets, because it allows them to pick and choose only those items that have value to them. This can leave you with a bunch of “odd lot” assets to dispose of. But depending on the circumstances, an asset sale may still be to your advantage.
Sellers typically prefer to sell stock, because it allows them to sell their entire practice, which is often worth more than the sum of its parts, and often provides tax advantages.
The third option, merger, continues to grow in popularity and is a column subject in itself, and I will address it separately next month.
Tax issues must always be considered. Most private practices are corporations, and the sale of corporate stock will result in a long-term capital gain that will be taxed – currently at 15%-20%. As the saying goes, it’s not what you earn, it’s what you keep. So it may benefit you to accept a slightly lower price if the sale can be structured to provide significantly lower tax treatment. However, any gain that does not qualify as a long-term capital gain will be taxed as regular income – currently in the 32%-37% percent range – plus a Social Security tax of about 15%.
Payment in installments is a popular way to defer taxes, since they are incurred on each installment as it is paid; but such payments may be mistaken by the IRS for payments for referrals, which is illegal. And there is always the problem of making certain all payments are eventually made.
You may wish to continue working at the practice as an employee for an agreed-upon period of time, and this is often to the buyer’s advantage as well. Transitioning to new ownership in stages often maximizes the value of the business by improving patient retention, and allows patients to become accustomed to the transition. However, care must be taken, with the aid of good legal advice, to structure such an arrangement in a way that minimizes concerns of fraud and abuse.
Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].
FDA approves first PARP inhibitor for early BRCA+ breast cancer
BRCA+ breast cancer
Specifically, the new approval is for the adjuvant treatment of adult patients with high-risk early-stage HER2-negative, BRCA-mutated breast cancer who have completed chemotherapy and local treatment.
The FDA also approved BRACAnalysis CDx (Myriad Genetics), a companion diagnostic test to identify patients who may benefit from olaparib.
The latest approval was based on phase 3 OlympiA trial results, which showed a 42% improvement in invasive and distant disease-free survival with olaparib in comparison with placebo. Data from OlympiaA and other clinical studies also confirm BRACAnalysis CDx as “an effective test for patients deciding on their best treatment options,” Myriad Genetics noted in a press release.
The OlympiA results, as reported by this news organization, were presented during the plenary session of the American Society of Clinical Oncology 2021 annual meeting and were published in the New England Journal of Medicine.
Those findings prompted an ASCO “rapid recommendation” updating of ASCO’s 2020 guidelines for the management of hereditary breast cancer.
The latest results from OlympiA show that olaparib reduced the risk of death by 32% (hazard ratio, 0.68) in comparison with placebo, according to a company press release announcing the approval. Overall survival data are slated for presentation at a European Society for Medical Oncology Virtual Plenary session on March 16, 2022.
A version of this article first appeared on Medscape.com.
Specifically, the new approval is for the adjuvant treatment of adult patients with high-risk early-stage HER2-negative, BRCA-mutated breast cancer who have completed chemotherapy and local treatment.
The FDA also approved BRACAnalysis CDx (Myriad Genetics), a companion diagnostic test to identify patients who may benefit from olaparib.
The latest approval was based on phase 3 OlympiA trial results, which showed a 42% improvement in invasive and distant disease-free survival with olaparib in comparison with placebo. Data from OlympiaA and other clinical studies also confirm BRACAnalysis CDx as “an effective test for patients deciding on their best treatment options,” Myriad Genetics noted in a press release.
The OlympiA results, as reported by this news organization, were presented during the plenary session of the American Society of Clinical Oncology 2021 annual meeting and were published in the New England Journal of Medicine.
Those findings prompted an ASCO “rapid recommendation” updating of ASCO’s 2020 guidelines for the management of hereditary breast cancer.
The latest results from OlympiA show that olaparib reduced the risk of death by 32% (hazard ratio, 0.68) in comparison with placebo, according to a company press release announcing the approval. Overall survival data are slated for presentation at a European Society for Medical Oncology Virtual Plenary session on March 16, 2022.
A version of this article first appeared on Medscape.com.
Specifically, the new approval is for the adjuvant treatment of adult patients with high-risk early-stage HER2-negative, BRCA-mutated breast cancer who have completed chemotherapy and local treatment.
The FDA also approved BRACAnalysis CDx (Myriad Genetics), a companion diagnostic test to identify patients who may benefit from olaparib.
The latest approval was based on phase 3 OlympiA trial results, which showed a 42% improvement in invasive and distant disease-free survival with olaparib in comparison with placebo. Data from OlympiaA and other clinical studies also confirm BRACAnalysis CDx as “an effective test for patients deciding on their best treatment options,” Myriad Genetics noted in a press release.
The OlympiA results, as reported by this news organization, were presented during the plenary session of the American Society of Clinical Oncology 2021 annual meeting and were published in the New England Journal of Medicine.
Those findings prompted an ASCO “rapid recommendation” updating of ASCO’s 2020 guidelines for the management of hereditary breast cancer.
The latest results from OlympiA show that olaparib reduced the risk of death by 32% (hazard ratio, 0.68) in comparison with placebo, according to a company press release announcing the approval. Overall survival data are slated for presentation at a European Society for Medical Oncology Virtual Plenary session on March 16, 2022.
A version of this article first appeared on Medscape.com.
BRCA+ breast cancer
BRCA+ breast cancer
Air trapping common in patients with long COVID
, according to a prospective study that compared 100 COVID-19 survivors who had persistent symptoms and 106 healthy control persons.
“Something is going on in the distal airways related to either inflammation or fibrosis that is giving us a signal of air trapping,” noted senior author Alejandro P. Comellas, MD, in a press release. The study was stimulated by reports from University of Iowa clinicians noting that many patients with initial SARS-CoV-2 infection who were either hospitalized or were treated in the ambulatory setting later reported shortness of breath and other respiratory symptoms indicative of chronic lung disease.
Study results
Investigators classified patients (mean age, 48 years; 66 women) with post-acute sequelae of COVID-19 according to whether they were ambulatory (67%), hospitalized (17%), or required treatment in the intensive care unit (16%). They then compared CT findings of patients who had COVID-19 and persistent symptoms with those of a healthy control group.
COVID-19 severity did not affect the percentage of cases of lung with air trapping among these patients. Air trapping occurred at rates of 25.4% among ambulatory patients, 34.6% in hospitalized patients, and in 27.3% of those requiring intensive care (P = .10). The percentage of lungs affected by air trapping in ambulatory participants was sharply and significantly higher than in healthy controls (25.4% vs. 7.2%; P < .001). Also, air trapping persisted; it was still present in 8 of 9 participants who underwent imaging more than 200 days post diagnosis.
Qualitative analysis of chest CT images showed that the most common imaging abnormality was air trapping (58%); ground glass opacities (GGOs) were found in 51% (46/91), note Dr. Comellas and coauthors. This suggests ongoing lung inflammation, edema, or fibrosis. These symptoms are often observed during acute COVID-19, frequently in an organizing pneumonia pattern, and have been shown to persist for months after infection in survivors of severe disease. The mean percentage of total lung classified as having regional GGOs on chest CT scans was 13.2% and 28.7%, respectively, in the hospitalized and ICU groups, both very much higher than in the ambulatory group, at 3.7% (P < .001 for both). Among healthy controls, the GGO rate on chest CT was only 0.06% (P < .001).
In addition, air trapping correlated with the ratio of residual volume to total lung capacity (r = 0.6; P < .001) but not with spirometry results. In fact, the investigators did not observe airflow obstruction by spirometry in any group, suggesting that air trapping in these patients involves only small rather than large airways and that these small airways contribute little to total airway resistance. Only when a large percentage, perhaps 75% or more, of all small airways are obstructed will spirometry pick up small airways disease, the authors observe.
Continuing disease
The findings taken together suggest that functional small airways disease and air trapping are a consequence of SARS-CoV-2 infection, according to Dr. Comellas. “If a portion of patients continues to have small airways disease, then we need to think about the mechanisms behind it,” he said. “It could be something related to inflammation that’s reversible, or it may be something related to a scar that is irreversible, and then we need to look at ways to prevent further progression of the disease.” Furthermore, “studies aimed at determining the natural history of functional small airways disease in patients with post-acute sequelae of COVID-19 and the biological mechanisms that underlie these findings are urgently needed to identify therapeutic and preventative interventions,” Dr. Comellas, professor of internal medicine at Carver College of Medicine, University of Iowa, Iowa City, concluded.
The study limitations, the authors state, include the fact that theirs was a single-center study that enrolled participants infected early during the COVID-19 pandemic and did not include patients with Delta or Omicron variants, thus limiting the generalizability of the findings.
The study was published in Radiology.
The reported findings “indicate a long-term impact on bronchiolar obstruction,” states Brett M. Elicker, MD, professor of clinical radiology, University of California, San Francisco, in an accompanying editorial . Because collagen may be absorbed for months after an acute insult, it is not entirely clear whether the abnormalities seen in the current study will be permanent. He said further, “the presence of ground glass opacity and/or fibrosis on CT were most common in the patients admitted to the ICU and likely correspond to post-organizing pneumonia and/or post-diffuse alveolar damage fibrosis.”
Dr. Elicker also pointed out that organizing pneumonia is especially common among patients with COVID-19 and is usually highly steroid-responsive. The opacities improve or resolve with treatment, but sometimes residual fibrosis occurs. “Longer-term studies assessing the clinical and imaging manifestations 1-2 years after the initial infection are needed to fully ascertain the permanent manifestations of post-COVID fibrosis.”
The study was supported by grants from the National Institutes of Health. The authors and Dr. Elicker have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, according to a prospective study that compared 100 COVID-19 survivors who had persistent symptoms and 106 healthy control persons.
“Something is going on in the distal airways related to either inflammation or fibrosis that is giving us a signal of air trapping,” noted senior author Alejandro P. Comellas, MD, in a press release. The study was stimulated by reports from University of Iowa clinicians noting that many patients with initial SARS-CoV-2 infection who were either hospitalized or were treated in the ambulatory setting later reported shortness of breath and other respiratory symptoms indicative of chronic lung disease.
Study results
Investigators classified patients (mean age, 48 years; 66 women) with post-acute sequelae of COVID-19 according to whether they were ambulatory (67%), hospitalized (17%), or required treatment in the intensive care unit (16%). They then compared CT findings of patients who had COVID-19 and persistent symptoms with those of a healthy control group.
COVID-19 severity did not affect the percentage of cases of lung with air trapping among these patients. Air trapping occurred at rates of 25.4% among ambulatory patients, 34.6% in hospitalized patients, and in 27.3% of those requiring intensive care (P = .10). The percentage of lungs affected by air trapping in ambulatory participants was sharply and significantly higher than in healthy controls (25.4% vs. 7.2%; P < .001). Also, air trapping persisted; it was still present in 8 of 9 participants who underwent imaging more than 200 days post diagnosis.
Qualitative analysis of chest CT images showed that the most common imaging abnormality was air trapping (58%); ground glass opacities (GGOs) were found in 51% (46/91), note Dr. Comellas and coauthors. This suggests ongoing lung inflammation, edema, or fibrosis. These symptoms are often observed during acute COVID-19, frequently in an organizing pneumonia pattern, and have been shown to persist for months after infection in survivors of severe disease. The mean percentage of total lung classified as having regional GGOs on chest CT scans was 13.2% and 28.7%, respectively, in the hospitalized and ICU groups, both very much higher than in the ambulatory group, at 3.7% (P < .001 for both). Among healthy controls, the GGO rate on chest CT was only 0.06% (P < .001).
In addition, air trapping correlated with the ratio of residual volume to total lung capacity (r = 0.6; P < .001) but not with spirometry results. In fact, the investigators did not observe airflow obstruction by spirometry in any group, suggesting that air trapping in these patients involves only small rather than large airways and that these small airways contribute little to total airway resistance. Only when a large percentage, perhaps 75% or more, of all small airways are obstructed will spirometry pick up small airways disease, the authors observe.
Continuing disease
The findings taken together suggest that functional small airways disease and air trapping are a consequence of SARS-CoV-2 infection, according to Dr. Comellas. “If a portion of patients continues to have small airways disease, then we need to think about the mechanisms behind it,” he said. “It could be something related to inflammation that’s reversible, or it may be something related to a scar that is irreversible, and then we need to look at ways to prevent further progression of the disease.” Furthermore, “studies aimed at determining the natural history of functional small airways disease in patients with post-acute sequelae of COVID-19 and the biological mechanisms that underlie these findings are urgently needed to identify therapeutic and preventative interventions,” Dr. Comellas, professor of internal medicine at Carver College of Medicine, University of Iowa, Iowa City, concluded.
The study limitations, the authors state, include the fact that theirs was a single-center study that enrolled participants infected early during the COVID-19 pandemic and did not include patients with Delta or Omicron variants, thus limiting the generalizability of the findings.
The study was published in Radiology.
The reported findings “indicate a long-term impact on bronchiolar obstruction,” states Brett M. Elicker, MD, professor of clinical radiology, University of California, San Francisco, in an accompanying editorial . Because collagen may be absorbed for months after an acute insult, it is not entirely clear whether the abnormalities seen in the current study will be permanent. He said further, “the presence of ground glass opacity and/or fibrosis on CT were most common in the patients admitted to the ICU and likely correspond to post-organizing pneumonia and/or post-diffuse alveolar damage fibrosis.”
Dr. Elicker also pointed out that organizing pneumonia is especially common among patients with COVID-19 and is usually highly steroid-responsive. The opacities improve or resolve with treatment, but sometimes residual fibrosis occurs. “Longer-term studies assessing the clinical and imaging manifestations 1-2 years after the initial infection are needed to fully ascertain the permanent manifestations of post-COVID fibrosis.”
The study was supported by grants from the National Institutes of Health. The authors and Dr. Elicker have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, according to a prospective study that compared 100 COVID-19 survivors who had persistent symptoms and 106 healthy control persons.
“Something is going on in the distal airways related to either inflammation or fibrosis that is giving us a signal of air trapping,” noted senior author Alejandro P. Comellas, MD, in a press release. The study was stimulated by reports from University of Iowa clinicians noting that many patients with initial SARS-CoV-2 infection who were either hospitalized or were treated in the ambulatory setting later reported shortness of breath and other respiratory symptoms indicative of chronic lung disease.
Study results
Investigators classified patients (mean age, 48 years; 66 women) with post-acute sequelae of COVID-19 according to whether they were ambulatory (67%), hospitalized (17%), or required treatment in the intensive care unit (16%). They then compared CT findings of patients who had COVID-19 and persistent symptoms with those of a healthy control group.
COVID-19 severity did not affect the percentage of cases of lung with air trapping among these patients. Air trapping occurred at rates of 25.4% among ambulatory patients, 34.6% in hospitalized patients, and in 27.3% of those requiring intensive care (P = .10). The percentage of lungs affected by air trapping in ambulatory participants was sharply and significantly higher than in healthy controls (25.4% vs. 7.2%; P < .001). Also, air trapping persisted; it was still present in 8 of 9 participants who underwent imaging more than 200 days post diagnosis.
Qualitative analysis of chest CT images showed that the most common imaging abnormality was air trapping (58%); ground glass opacities (GGOs) were found in 51% (46/91), note Dr. Comellas and coauthors. This suggests ongoing lung inflammation, edema, or fibrosis. These symptoms are often observed during acute COVID-19, frequently in an organizing pneumonia pattern, and have been shown to persist for months after infection in survivors of severe disease. The mean percentage of total lung classified as having regional GGOs on chest CT scans was 13.2% and 28.7%, respectively, in the hospitalized and ICU groups, both very much higher than in the ambulatory group, at 3.7% (P < .001 for both). Among healthy controls, the GGO rate on chest CT was only 0.06% (P < .001).
In addition, air trapping correlated with the ratio of residual volume to total lung capacity (r = 0.6; P < .001) but not with spirometry results. In fact, the investigators did not observe airflow obstruction by spirometry in any group, suggesting that air trapping in these patients involves only small rather than large airways and that these small airways contribute little to total airway resistance. Only when a large percentage, perhaps 75% or more, of all small airways are obstructed will spirometry pick up small airways disease, the authors observe.
Continuing disease
The findings taken together suggest that functional small airways disease and air trapping are a consequence of SARS-CoV-2 infection, according to Dr. Comellas. “If a portion of patients continues to have small airways disease, then we need to think about the mechanisms behind it,” he said. “It could be something related to inflammation that’s reversible, or it may be something related to a scar that is irreversible, and then we need to look at ways to prevent further progression of the disease.” Furthermore, “studies aimed at determining the natural history of functional small airways disease in patients with post-acute sequelae of COVID-19 and the biological mechanisms that underlie these findings are urgently needed to identify therapeutic and preventative interventions,” Dr. Comellas, professor of internal medicine at Carver College of Medicine, University of Iowa, Iowa City, concluded.
The study limitations, the authors state, include the fact that theirs was a single-center study that enrolled participants infected early during the COVID-19 pandemic and did not include patients with Delta or Omicron variants, thus limiting the generalizability of the findings.
The study was published in Radiology.
The reported findings “indicate a long-term impact on bronchiolar obstruction,” states Brett M. Elicker, MD, professor of clinical radiology, University of California, San Francisco, in an accompanying editorial . Because collagen may be absorbed for months after an acute insult, it is not entirely clear whether the abnormalities seen in the current study will be permanent. He said further, “the presence of ground glass opacity and/or fibrosis on CT were most common in the patients admitted to the ICU and likely correspond to post-organizing pneumonia and/or post-diffuse alveolar damage fibrosis.”
Dr. Elicker also pointed out that organizing pneumonia is especially common among patients with COVID-19 and is usually highly steroid-responsive. The opacities improve or resolve with treatment, but sometimes residual fibrosis occurs. “Longer-term studies assessing the clinical and imaging manifestations 1-2 years after the initial infection are needed to fully ascertain the permanent manifestations of post-COVID fibrosis.”
The study was supported by grants from the National Institutes of Health. The authors and Dr. Elicker have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM RADIOLOGY