Opinion

This transcript has been edited for clarity. 

Lawyers have the saying, “Bad facts make for bad cases; bad cases make for bad laws.” What we’re seeing, I fear, all too often in discussions about reproductive rights, reproductive behavior, and attempts to regulate and legislate with respect to abortion and contraception are many bad facts.

I do think it’s important that science and medicine speak up in local settings and every opportunity they have, not so much to say what government should do or to say whether they think a particular law is good or bad, but certainly to get the facts straight in their role as doctors, sometimes as scientists, and as caregivers.

Bad facts are making many bad policies in the reproductive behavior space. For example, there are many people, mainly on the conservative side, who are saying things like intrauterine devices, emergency contraception, and even birth control cause abortions. That is simply not true.

There are interventions that prevent fertilization from occurring. There are also interventions that prevent implantation from occurring. Neither of those are abortions. If an embryo has not implanted into a womb, it is not, by any biological definition, a pregnancy. 

In situations where a barrier method or something else prevents sperm and egg from meeting or if there is an agent that prevents an egg from implanting, these are facts that legislators, the public, and even your patients need to understand if they’re going to make sound policy about access to methods used to control reproduction.

Similarly, you can see debates about whether embryos are deserving of rights. An Alabama court has ruled that embryos are tiny children. A court can say what it wishes in terms of legal status, but it shouldn’t be deviating from the facts. 

The facts are clear. Embryos outside of a uterus implanted are not babies. They are not children. At most, an embryo in a dish might be considered, let’s say, a possible person. Once it implants in a uterus, it may become a potential person because it then still has a failure rate, postimplantation, of not becoming a baby that’s very high. Approximately 40%-50% of such embryos are genetically flawed and aren’t going to be able to turn into a child.

The notion that every embryo, whether it’s stored in a tank or sitting in a dish, is somehow a tiny child, factually is just not true. You can’t make good policy if you ignore the facts. People may wish to protect embryos. They may wish to restrict in vitro fertilization. They may wish to have people implant any embryo that is created and mandate that it has to happen because they don’t want any tiny children not to be brought to term.

Factually, they’re operating outside the realm of what biology and medicine know. There’s no tiny baby, no homunculus, or no preformed baby inside an embryo. An egg that simply fails to implant is not technically even a pregnancy. 

I think all of us have an obligation when we’re in disputes, wherever they occur, whether we’re fighting about laws, having an argument with the neighbors, or speaking to younger high school students or even patients, we need to try to make clear the facts about what we know about eggs, how birth control works, and embryos and their failure rate. 

We also have to be clear about the significance of saying the facts have to guide public policy. I think the facts should, but unfortunately, I don’t think that’s always been true in recent years. As efforts heat up to intervene more with things like contraception, getting the facts straight becomes even more important and more of a duty for those who know best.

Dr. Caplan is director, Division of Medical Ethics, New York University Langone Medical Center, New York. He served as a director, officer, partner, employee, adviser, consultant, or trustee for Johnson & Johnson’s Panel for Compassionate Drug Use (unpaid position). He is a contributing author and adviser for Medscape.

A version of this article first appeared on Medscape.com.

This transcript has been edited for clarity. 

Lawyers have the saying, “Bad facts make for bad cases; bad cases make for bad laws.” What we’re seeing, I fear, all too often in discussions about reproductive rights, reproductive behavior, and attempts to regulate and legislate with respect to abortion and contraception are many bad facts.

I do think it’s important that science and medicine speak up in local settings and every opportunity they have, not so much to say what government should do or to say whether they think a particular law is good or bad, but certainly to get the facts straight in their role as doctors, sometimes as scientists, and as caregivers.

Bad facts are making many bad policies in the reproductive behavior space. For example, there are many people, mainly on the conservative side, who are saying things like intrauterine devices, emergency contraception, and even birth control cause abortions. That is simply not true.

There are interventions that prevent fertilization from occurring. There are also interventions that prevent implantation from occurring. Neither of those are abortions. If an embryo has not implanted into a womb, it is not, by any biological definition, a pregnancy. 

In situations where a barrier method or something else prevents sperm and egg from meeting or if there is an agent that prevents an egg from implanting, these are facts that legislators, the public, and even your patients need to understand if they’re going to make sound policy about access to methods used to control reproduction.

Similarly, you can see debates about whether embryos are deserving of rights. An Alabama court has ruled that embryos are tiny children. A court can say what it wishes in terms of legal status, but it shouldn’t be deviating from the facts. 

The facts are clear. Embryos outside of a uterus implanted are not babies. They are not children. At most, an embryo in a dish might be considered, let’s say, a possible person. Once it implants in a uterus, it may become a potential person because it then still has a failure rate, postimplantation, of not becoming a baby that’s very high. Approximately 40%-50% of such embryos are genetically flawed and aren’t going to be able to turn into a child.

The notion that every embryo, whether it’s stored in a tank or sitting in a dish, is somehow a tiny child, factually is just not true. You can’t make good policy if you ignore the facts. People may wish to protect embryos. They may wish to restrict in vitro fertilization. They may wish to have people implant any embryo that is created and mandate that it has to happen because they don’t want any tiny children not to be brought to term.

Factually, they’re operating outside the realm of what biology and medicine know. There’s no tiny baby, no homunculus, or no preformed baby inside an embryo. An egg that simply fails to implant is not technically even a pregnancy. 

I think all of us have an obligation when we’re in disputes, wherever they occur, whether we’re fighting about laws, having an argument with the neighbors, or speaking to younger high school students or even patients, we need to try to make clear the facts about what we know about eggs, how birth control works, and embryos and their failure rate. 

We also have to be clear about the significance of saying the facts have to guide public policy. I think the facts should, but unfortunately, I don’t think that’s always been true in recent years. As efforts heat up to intervene more with things like contraception, getting the facts straight becomes even more important and more of a duty for those who know best.

Dr. Caplan is director, Division of Medical Ethics, New York University Langone Medical Center, New York. He served as a director, officer, partner, employee, adviser, consultant, or trustee for Johnson & Johnson’s Panel for Compassionate Drug Use (unpaid position). He is a contributing author and adviser for Medscape.

A version of this article first appeared on Medscape.com.

This transcript has been edited for clarity. 

Lawyers have the saying, “Bad facts make for bad cases; bad cases make for bad laws.” What we’re seeing, I fear, all too often in discussions about reproductive rights, reproductive behavior, and attempts to regulate and legislate with respect to abortion and contraception are many bad facts.

I do think it’s important that science and medicine speak up in local settings and every opportunity they have, not so much to say what government should do or to say whether they think a particular law is good or bad, but certainly to get the facts straight in their role as doctors, sometimes as scientists, and as caregivers.

Bad facts are making many bad policies in the reproductive behavior space. For example, there are many people, mainly on the conservative side, who are saying things like intrauterine devices, emergency contraception, and even birth control cause abortions. That is simply not true.

There are interventions that prevent fertilization from occurring. There are also interventions that prevent implantation from occurring. Neither of those are abortions. If an embryo has not implanted into a womb, it is not, by any biological definition, a pregnancy. 

In situations where a barrier method or something else prevents sperm and egg from meeting or if there is an agent that prevents an egg from implanting, these are facts that legislators, the public, and even your patients need to understand if they’re going to make sound policy about access to methods used to control reproduction.

Similarly, you can see debates about whether embryos are deserving of rights. An Alabama court has ruled that embryos are tiny children. A court can say what it wishes in terms of legal status, but it shouldn’t be deviating from the facts. 

The facts are clear. Embryos outside of a uterus implanted are not babies. They are not children. At most, an embryo in a dish might be considered, let’s say, a possible person. Once it implants in a uterus, it may become a potential person because it then still has a failure rate, postimplantation, of not becoming a baby that’s very high. Approximately 40%-50% of such embryos are genetically flawed and aren’t going to be able to turn into a child.

The notion that every embryo, whether it’s stored in a tank or sitting in a dish, is somehow a tiny child, factually is just not true. You can’t make good policy if you ignore the facts. People may wish to protect embryos. They may wish to restrict in vitro fertilization. They may wish to have people implant any embryo that is created and mandate that it has to happen because they don’t want any tiny children not to be brought to term.

Factually, they’re operating outside the realm of what biology and medicine know. There’s no tiny baby, no homunculus, or no preformed baby inside an embryo. An egg that simply fails to implant is not technically even a pregnancy. 

I think all of us have an obligation when we’re in disputes, wherever they occur, whether we’re fighting about laws, having an argument with the neighbors, or speaking to younger high school students or even patients, we need to try to make clear the facts about what we know about eggs, how birth control works, and embryos and their failure rate. 

We also have to be clear about the significance of saying the facts have to guide public policy. I think the facts should, but unfortunately, I don’t think that’s always been true in recent years. As efforts heat up to intervene more with things like contraception, getting the facts straight becomes even more important and more of a duty for those who know best.

Dr. Caplan is director, Division of Medical Ethics, New York University Langone Medical Center, New York. He served as a director, officer, partner, employee, adviser, consultant, or trustee for Johnson & Johnson’s Panel for Compassionate Drug Use (unpaid position). He is a contributing author and adviser for Medscape.

A version of this article first appeared on Medscape.com.

While there may be some lactation consultants who disagree, in my experience counseling women attempting to breastfeed is more art than science. Well before the American Academy of Pediatrics (AAP) began to offer mini courses on breastfeeding for practitioners I was left to help new mothers based on watching my wife nurse our three children and what scraps of common sense I could sweep up off the floor.

Using my own benchmarks of success I would say I did a decent job with dyads who sought my help. I began by accepting that even under optimal conditions, not every woman and/or child can successfully breastfeed. None of the infants died or was hospitalized with dehydration. A few may have required some additional phototherapy, but they all completed infancy in good shape. On the maternal side I am sure there were a few mothers who had lingering feelings of inadequacy because they had “failed” at breastfeeding. But, for the most part, I think I succeeded in helping new mothers remain as mentally healthy as they could be given the rigors of motherhood. At least I gave it my best shot.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at pdnews@mdedge.com.

While there may be some lactation consultants who disagree, in my experience counseling women attempting to breastfeed is more art than science. Well before the American Academy of Pediatrics (AAP) began to offer mini courses on breastfeeding for practitioners I was left to help new mothers based on watching my wife nurse our three children and what scraps of common sense I could sweep up off the floor.

Using my own benchmarks of success I would say I did a decent job with dyads who sought my help. I began by accepting that even under optimal conditions, not every woman and/or child can successfully breastfeed. None of the infants died or was hospitalized with dehydration. A few may have required some additional phototherapy, but they all completed infancy in good shape. On the maternal side I am sure there were a few mothers who had lingering feelings of inadequacy because they had “failed” at breastfeeding. But, for the most part, I think I succeeded in helping new mothers remain as mentally healthy as they could be given the rigors of motherhood. At least I gave it my best shot.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at pdnews@mdedge.com.

While there may be some lactation consultants who disagree, in my experience counseling women attempting to breastfeed is more art than science. Well before the American Academy of Pediatrics (AAP) began to offer mini courses on breastfeeding for practitioners I was left to help new mothers based on watching my wife nurse our three children and what scraps of common sense I could sweep up off the floor.

Using my own benchmarks of success I would say I did a decent job with dyads who sought my help. I began by accepting that even under optimal conditions, not every woman and/or child can successfully breastfeed. None of the infants died or was hospitalized with dehydration. A few may have required some additional phototherapy, but they all completed infancy in good shape. On the maternal side I am sure there were a few mothers who had lingering feelings of inadequacy because they had “failed” at breastfeeding. But, for the most part, I think I succeeded in helping new mothers remain as mentally healthy as they could be given the rigors of motherhood. At least I gave it my best shot.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at pdnews@mdedge.com.

A 25-year-old man comes in with a pulled muscle. You ask if he has anything else to discuss. Sheepishly, he says he is concerned about his use of pornography. 

A 45-year-old woman struggling with depression finds herself persistently seeking sex outside the bounds of her long-term relationship. Her partner is threatening to leave. She is devastated and tells you she doesn’t understand her own behavior. 

Do these patients have some form of sex addiction? How should a primary care clinician intervene? Is a referral to a 12-step program for sex addiction the right choice? What other options exist? Is a diagnosis — let alone treatment — possible or appropriate? 
 

‘Who Are You Calling “Abnormal” ’?

Normal is not a meaningful concept in human sexual behavior. To quote the sex therapist Marty Klein, PhD: “Normal is just a setting on the dryer.” 

The same goes among partners: What is “normal” for one person in a sexual relationship may discomfit another. In partnerships, we have differences around all sorts of issues, from finances to parenting to how to load the dishwasher. Why should sex, sexual desire, and sexual frequency be different? 

Remember: Shame, fear, and secrecy often play a role in perpetuating behaviors that cause distress. Helping our patients accept and embrace their whole selves can provide important healing, relief from anxiety, and may even help them regulate their actions. Feeling less shame, fear, and secrecy may facilitate safer choices about sex, as well as testing and treatment for sexually transmitted infections.

The International Classification of Diseases-11 includes compulsive sexual behavior disorder (CSBD)as an attempt to create consensus around a complicated, and hotly debated, problem to facilitate diagnosis and research. Syndromes similar to CSBD have had many names: “hypersexual disorder,” “sexual addiction,” “sexual compulsivity,” and “out-of-control sexual behavior.” A sizable cohort of the sexuality research community casts doubt on whether CSBD is even a discrete diagnosis. 

According to the ICD-11, CSBD is characterized by “intense, repetitive sexual impulses or urges that are experienced as irresistible or uncontrollable” and result in significant distress or functional impairment.

This diagnosis has several important rule-outs. First, paraphilias, defined as a set of nonconsensual sexual behaviors and interests, are excluded. Another is that distress exclusively related to moral judgment or social disapproval is not sufficient for a diagnosis of CSBD. Finally, the diagnosis hinges on distress and does not rely on frequency of any type of sexual behavior. Some people experience significant distress over behaviors in which they engage infrequently, whereas others may have no distress from activities in which they engage quite frequently. 

In one study from Germany, 5% of men and 3% of women met criteria for CSBD. A small US study found the number to be 10% and 7%, respectively. The diagnosis is not simple. Compulsive sexual behavior can be secondary to other mental health or medical conditions. Behaviors sometimes confused with CSBD can result from neurologic diseases, such as frontal brain lesions or frontotemporal dementia, as well as the use of substances and medications that enhance dopaminergic activity. 

Impaired control over sexual impulses occurs in manic and hypomanic episodes. Compulsive sexual behavior frequently co-occurs with mood disorders, obsessive-compulsive disorder, attention-deficit/hyperactivity disorder, and substance use disorders. Those meeting criteria for CSBD may engage in sexual behaviors as a way of coping with depression, anxiety, boredom, loneliness, or other negative affective states.  

The diagnosis of CSBD may be useful for clinicians. However, many, perhaps most, patients who present with concerns about their sexual behavior will fail to meet most criteria for CSBD. Their problem is of shorter duration, related to morality, external disapproval, lack of sexual health information, and anxiety about diverse erotic interests. It may be helpful for them to understand that they are not in the grip of a lifelong disorder but are experiencing common life challenges. 

Societal concerns about sexually explicit media, often called pornography, are complex, conflicting, and catastrophizing. Some studies indicate that sexually explicit media are positive for both individual and relational sexual satisfaction; other studies have found negative effects on sexual function. Concerns about pornography often are conflated with taboos about solo sexual activity. Ironically, use of pornography is associated with fear of addiction to pornography, creating a spiral of negative self-perception. 

Consequences of sexual behavior may induce distress, even if a person doesn’t meet criteria for CSBD, such as potential dissolution of a marriage, loss of a job, excessive spending, sexually transmitted infections, other health concerns, and even legal problems. Sexual behavior might not be the central issue but rather an offshoot of relational distress, a mental health disorder, or a dysfunctional coping style. 

Guilt and shame can act as potent contributors to maintaining the behaviors as well as promoting secrecy around them. Sexual medicine experts recommend avoiding interventions that increase the experience of discrimination and stigma and avoiding the pathologization of the behaviors of sexually diverse individuals. As in so many aspects of medical care, we must walk in our patients’ shoes and avoid imposing on them our own moral or religious values. 
 

What Can a Primary Care Provider Do?  

When a patient is concerned about sexual behavior that feels out of control, primary care providers have an important role in evaluating for neurologic disease or side effects related to the use of medication or other substances, and facilitating psychiatric assessment to evaluate for mental health comorbidities, past trauma, and associated attachment disorders. 

Our patients need resources to tease out the individual and relational problems that may arise. Seek out well-trained sex therapy colleagues in your community. The American Association of Sexuality Educators, Counselors, and Therapists (AASECT) is one certifying body in the United States for sex therapy. 

Because of the heterogeneity of those who present with out-of-control sexual behavior, no one treatment fits all. Twelve-step programs, especially those with a focus on sexual “abstinence,” may not be the best choice. Many psychotherapeutic modalities are effective and often focus on addressing underlying or unrecognized mental health concerns, provide training on self-regulation and urge management, and relationship skills. Most important, the therapist needs to be sexologically informed and aware of their own biases around sexuality. Medical treatments are not recommended without concurrent psychological intervention. 

Relational sex therapy can help couples create clear relational agreements that work for both parties (or, in polyamorous relationships, everyone involved). Relational distress also may be a stimulus for individual psychotherapy. 

Back to these two patients. 

The 25-year-old could be counseled that use of sexually explicit media and solo sex are not inherently bad or damaging. When used for pleasure and enjoyment, they do not lead to problems with partnered sex or cause sexual dysfunction. Counseling him to move toward social engagement and life goals, rather than away from pornography, may be all that is necessary. 

Our second patient probably will need more intensive treatment, including medication management for her mood and referral to a certified sex therapist who has expertise in working with out-of-control sexual behavior. When she returns to see you in follow-up, she ideally expresses reduced shame, more autonomy, and renewed connection to her values, and she is keeping her relational agreements without sacrificing her sexual needs. 
 

Dr. Kranz is medical director, Rochester Center for Sexual Wellness; assistant professor of Clinical Family Medicine and Obstetrics and Gynecology, University of Rochester Medical Center, Rochester, New York. Dr. Kranz has disclosed no relevant financial relationships. Dr. Rosen is director of Behavioral Health, Rochester Center for Sexual Wellness, Rochester, New York. He has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

A 25-year-old man comes in with a pulled muscle. You ask if he has anything else to discuss. Sheepishly, he says he is concerned about his use of pornography. 

A 45-year-old woman struggling with depression finds herself persistently seeking sex outside the bounds of her long-term relationship. Her partner is threatening to leave. She is devastated and tells you she doesn’t understand her own behavior. 

Do these patients have some form of sex addiction? How should a primary care clinician intervene? Is a referral to a 12-step program for sex addiction the right choice? What other options exist? Is a diagnosis — let alone treatment — possible or appropriate? 
 

‘Who Are You Calling “Abnormal” ’?

Normal is not a meaningful concept in human sexual behavior. To quote the sex therapist Marty Klein, PhD: “Normal is just a setting on the dryer.” 

The same goes among partners: What is “normal” for one person in a sexual relationship may discomfit another. In partnerships, we have differences around all sorts of issues, from finances to parenting to how to load the dishwasher. Why should sex, sexual desire, and sexual frequency be different? 

Remember: Shame, fear, and secrecy often play a role in perpetuating behaviors that cause distress. Helping our patients accept and embrace their whole selves can provide important healing, relief from anxiety, and may even help them regulate their actions. Feeling less shame, fear, and secrecy may facilitate safer choices about sex, as well as testing and treatment for sexually transmitted infections.

The International Classification of Diseases-11 includes compulsive sexual behavior disorder (CSBD)as an attempt to create consensus around a complicated, and hotly debated, problem to facilitate diagnosis and research. Syndromes similar to CSBD have had many names: “hypersexual disorder,” “sexual addiction,” “sexual compulsivity,” and “out-of-control sexual behavior.” A sizable cohort of the sexuality research community casts doubt on whether CSBD is even a discrete diagnosis. 

According to the ICD-11, CSBD is characterized by “intense, repetitive sexual impulses or urges that are experienced as irresistible or uncontrollable” and result in significant distress or functional impairment.

This diagnosis has several important rule-outs. First, paraphilias, defined as a set of nonconsensual sexual behaviors and interests, are excluded. Another is that distress exclusively related to moral judgment or social disapproval is not sufficient for a diagnosis of CSBD. Finally, the diagnosis hinges on distress and does not rely on frequency of any type of sexual behavior. Some people experience significant distress over behaviors in which they engage infrequently, whereas others may have no distress from activities in which they engage quite frequently. 

In one study from Germany, 5% of men and 3% of women met criteria for CSBD. A small US study found the number to be 10% and 7%, respectively. The diagnosis is not simple. Compulsive sexual behavior can be secondary to other mental health or medical conditions. Behaviors sometimes confused with CSBD can result from neurologic diseases, such as frontal brain lesions or frontotemporal dementia, as well as the use of substances and medications that enhance dopaminergic activity. 

Impaired control over sexual impulses occurs in manic and hypomanic episodes. Compulsive sexual behavior frequently co-occurs with mood disorders, obsessive-compulsive disorder, attention-deficit/hyperactivity disorder, and substance use disorders. Those meeting criteria for CSBD may engage in sexual behaviors as a way of coping with depression, anxiety, boredom, loneliness, or other negative affective states.  

The diagnosis of CSBD may be useful for clinicians. However, many, perhaps most, patients who present with concerns about their sexual behavior will fail to meet most criteria for CSBD. Their problem is of shorter duration, related to morality, external disapproval, lack of sexual health information, and anxiety about diverse erotic interests. It may be helpful for them to understand that they are not in the grip of a lifelong disorder but are experiencing common life challenges. 

Societal concerns about sexually explicit media, often called pornography, are complex, conflicting, and catastrophizing. Some studies indicate that sexually explicit media are positive for both individual and relational sexual satisfaction; other studies have found negative effects on sexual function. Concerns about pornography often are conflated with taboos about solo sexual activity. Ironically, use of pornography is associated with fear of addiction to pornography, creating a spiral of negative self-perception. 

Consequences of sexual behavior may induce distress, even if a person doesn’t meet criteria for CSBD, such as potential dissolution of a marriage, loss of a job, excessive spending, sexually transmitted infections, other health concerns, and even legal problems. Sexual behavior might not be the central issue but rather an offshoot of relational distress, a mental health disorder, or a dysfunctional coping style. 

Guilt and shame can act as potent contributors to maintaining the behaviors as well as promoting secrecy around them. Sexual medicine experts recommend avoiding interventions that increase the experience of discrimination and stigma and avoiding the pathologization of the behaviors of sexually diverse individuals. As in so many aspects of medical care, we must walk in our patients’ shoes and avoid imposing on them our own moral or religious values. 
 

What Can a Primary Care Provider Do?  

When a patient is concerned about sexual behavior that feels out of control, primary care providers have an important role in evaluating for neurologic disease or side effects related to the use of medication or other substances, and facilitating psychiatric assessment to evaluate for mental health comorbidities, past trauma, and associated attachment disorders. 

Our patients need resources to tease out the individual and relational problems that may arise. Seek out well-trained sex therapy colleagues in your community. The American Association of Sexuality Educators, Counselors, and Therapists (AASECT) is one certifying body in the United States for sex therapy. 

Because of the heterogeneity of those who present with out-of-control sexual behavior, no one treatment fits all. Twelve-step programs, especially those with a focus on sexual “abstinence,” may not be the best choice. Many psychotherapeutic modalities are effective and often focus on addressing underlying or unrecognized mental health concerns, provide training on self-regulation and urge management, and relationship skills. Most important, the therapist needs to be sexologically informed and aware of their own biases around sexuality. Medical treatments are not recommended without concurrent psychological intervention. 

Relational sex therapy can help couples create clear relational agreements that work for both parties (or, in polyamorous relationships, everyone involved). Relational distress also may be a stimulus for individual psychotherapy. 

Back to these two patients. 

The 25-year-old could be counseled that use of sexually explicit media and solo sex are not inherently bad or damaging. When used for pleasure and enjoyment, they do not lead to problems with partnered sex or cause sexual dysfunction. Counseling him to move toward social engagement and life goals, rather than away from pornography, may be all that is necessary. 

Our second patient probably will need more intensive treatment, including medication management for her mood and referral to a certified sex therapist who has expertise in working with out-of-control sexual behavior. When she returns to see you in follow-up, she ideally expresses reduced shame, more autonomy, and renewed connection to her values, and she is keeping her relational agreements without sacrificing her sexual needs. 
 

Dr. Kranz is medical director, Rochester Center for Sexual Wellness; assistant professor of Clinical Family Medicine and Obstetrics and Gynecology, University of Rochester Medical Center, Rochester, New York. Dr. Kranz has disclosed no relevant financial relationships. Dr. Rosen is director of Behavioral Health, Rochester Center for Sexual Wellness, Rochester, New York. He has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

A 25-year-old man comes in with a pulled muscle. You ask if he has anything else to discuss. Sheepishly, he says he is concerned about his use of pornography. 

A 45-year-old woman struggling with depression finds herself persistently seeking sex outside the bounds of her long-term relationship. Her partner is threatening to leave. She is devastated and tells you she doesn’t understand her own behavior. 

Do these patients have some form of sex addiction? How should a primary care clinician intervene? Is a referral to a 12-step program for sex addiction the right choice? What other options exist? Is a diagnosis — let alone treatment — possible or appropriate? 
 

‘Who Are You Calling “Abnormal” ’?

Normal is not a meaningful concept in human sexual behavior. To quote the sex therapist Marty Klein, PhD: “Normal is just a setting on the dryer.” 

The same goes among partners: What is “normal” for one person in a sexual relationship may discomfit another. In partnerships, we have differences around all sorts of issues, from finances to parenting to how to load the dishwasher. Why should sex, sexual desire, and sexual frequency be different? 

Remember: Shame, fear, and secrecy often play a role in perpetuating behaviors that cause distress. Helping our patients accept and embrace their whole selves can provide important healing, relief from anxiety, and may even help them regulate their actions. Feeling less shame, fear, and secrecy may facilitate safer choices about sex, as well as testing and treatment for sexually transmitted infections.

The International Classification of Diseases-11 includes compulsive sexual behavior disorder (CSBD)as an attempt to create consensus around a complicated, and hotly debated, problem to facilitate diagnosis and research. Syndromes similar to CSBD have had many names: “hypersexual disorder,” “sexual addiction,” “sexual compulsivity,” and “out-of-control sexual behavior.” A sizable cohort of the sexuality research community casts doubt on whether CSBD is even a discrete diagnosis. 

According to the ICD-11, CSBD is characterized by “intense, repetitive sexual impulses or urges that are experienced as irresistible or uncontrollable” and result in significant distress or functional impairment.

This diagnosis has several important rule-outs. First, paraphilias, defined as a set of nonconsensual sexual behaviors and interests, are excluded. Another is that distress exclusively related to moral judgment or social disapproval is not sufficient for a diagnosis of CSBD. Finally, the diagnosis hinges on distress and does not rely on frequency of any type of sexual behavior. Some people experience significant distress over behaviors in which they engage infrequently, whereas others may have no distress from activities in which they engage quite frequently. 

In one study from Germany, 5% of men and 3% of women met criteria for CSBD. A small US study found the number to be 10% and 7%, respectively. The diagnosis is not simple. Compulsive sexual behavior can be secondary to other mental health or medical conditions. Behaviors sometimes confused with CSBD can result from neurologic diseases, such as frontal brain lesions or frontotemporal dementia, as well as the use of substances and medications that enhance dopaminergic activity. 

Impaired control over sexual impulses occurs in manic and hypomanic episodes. Compulsive sexual behavior frequently co-occurs with mood disorders, obsessive-compulsive disorder, attention-deficit/hyperactivity disorder, and substance use disorders. Those meeting criteria for CSBD may engage in sexual behaviors as a way of coping with depression, anxiety, boredom, loneliness, or other negative affective states.  

The diagnosis of CSBD may be useful for clinicians. However, many, perhaps most, patients who present with concerns about their sexual behavior will fail to meet most criteria for CSBD. Their problem is of shorter duration, related to morality, external disapproval, lack of sexual health information, and anxiety about diverse erotic interests. It may be helpful for them to understand that they are not in the grip of a lifelong disorder but are experiencing common life challenges. 

Societal concerns about sexually explicit media, often called pornography, are complex, conflicting, and catastrophizing. Some studies indicate that sexually explicit media are positive for both individual and relational sexual satisfaction; other studies have found negative effects on sexual function. Concerns about pornography often are conflated with taboos about solo sexual activity. Ironically, use of pornography is associated with fear of addiction to pornography, creating a spiral of negative self-perception. 

Consequences of sexual behavior may induce distress, even if a person doesn’t meet criteria for CSBD, such as potential dissolution of a marriage, loss of a job, excessive spending, sexually transmitted infections, other health concerns, and even legal problems. Sexual behavior might not be the central issue but rather an offshoot of relational distress, a mental health disorder, or a dysfunctional coping style. 

Guilt and shame can act as potent contributors to maintaining the behaviors as well as promoting secrecy around them. Sexual medicine experts recommend avoiding interventions that increase the experience of discrimination and stigma and avoiding the pathologization of the behaviors of sexually diverse individuals. As in so many aspects of medical care, we must walk in our patients’ shoes and avoid imposing on them our own moral or religious values. 
 

What Can a Primary Care Provider Do?  

When a patient is concerned about sexual behavior that feels out of control, primary care providers have an important role in evaluating for neurologic disease or side effects related to the use of medication or other substances, and facilitating psychiatric assessment to evaluate for mental health comorbidities, past trauma, and associated attachment disorders. 

Our patients need resources to tease out the individual and relational problems that may arise. Seek out well-trained sex therapy colleagues in your community. The American Association of Sexuality Educators, Counselors, and Therapists (AASECT) is one certifying body in the United States for sex therapy. 

Because of the heterogeneity of those who present with out-of-control sexual behavior, no one treatment fits all. Twelve-step programs, especially those with a focus on sexual “abstinence,” may not be the best choice. Many psychotherapeutic modalities are effective and often focus on addressing underlying or unrecognized mental health concerns, provide training on self-regulation and urge management, and relationship skills. Most important, the therapist needs to be sexologically informed and aware of their own biases around sexuality. Medical treatments are not recommended without concurrent psychological intervention. 

Relational sex therapy can help couples create clear relational agreements that work for both parties (or, in polyamorous relationships, everyone involved). Relational distress also may be a stimulus for individual psychotherapy. 

Back to these two patients. 

The 25-year-old could be counseled that use of sexually explicit media and solo sex are not inherently bad or damaging. When used for pleasure and enjoyment, they do not lead to problems with partnered sex or cause sexual dysfunction. Counseling him to move toward social engagement and life goals, rather than away from pornography, may be all that is necessary. 

Our second patient probably will need more intensive treatment, including medication management for her mood and referral to a certified sex therapist who has expertise in working with out-of-control sexual behavior. When she returns to see you in follow-up, she ideally expresses reduced shame, more autonomy, and renewed connection to her values, and she is keeping her relational agreements without sacrificing her sexual needs. 
 

Dr. Kranz is medical director, Rochester Center for Sexual Wellness; assistant professor of Clinical Family Medicine and Obstetrics and Gynecology, University of Rochester Medical Center, Rochester, New York. Dr. Kranz has disclosed no relevant financial relationships. Dr. Rosen is director of Behavioral Health, Rochester Center for Sexual Wellness, Rochester, New York. He has disclosed no relevant financial relationships.

A version of this article appeared on Medscape.com.

Dear Friends,

This issue of The New Gastroenterologist marks my first year completed as faculty. It has been both the best year and the HARDEST year. I celebrated many successes, felt intellectually and emotionally drained by difficult and complicated cases, and learned that there is so much more I still do not know. But that’s the beauty of our field — we are constantly learning to be better physicians for our patients. To trainees and my fellow gastroenterologists in practice, never stop asking questions!

In this issue’s “In Focus,” Dr. Rajan Singh and Dr. Baharak Moshiree describe a practical approach to patients with bloating by evaluating and investigating the pathophysiology and etiology of bloating, such as food intolerances, visceral hypersensitivity, pelvic floor dysfunction, abdominophrenic dyssynergia, gut dysmotility, and small intestinal bacterial overgrowth, as well as treatment management. In the “Short Clinical Review” section, Dr. Ahmad Bazarbashi and his colleagues review when to refer complex polyps to an advanced endoscopist and the different techniques of advanced tissue resection, including endoscopic mucosal resection, endoscopic submucosal dissection, submucosal tunneling endoscopic resection, and full thickness resection.

Locum practices have become more popular among gastroenterologists. Dr. Catherine Bartholomew is a retired professor of medicine who was chief of gastroenterology at an academic institution, and is now working as a GI locum after retirement. She details what a locum tenens is, the role of the company, being an independent contractor, and the benefits.

Navigating and negotiating maternity and paternity leave may be challenging in private practice. Dr. Marybeth Spanarkel gives her opinion on the nuances of maternity/paternity leave in private practices, what it may mean financially, and things to inquire of the practice if planning to have children.

As we move from joining non-traditional practices and navigating family planning with private practices, Dr. Vasu Appalaneni shares her experiences with financial planning for retirement. She describes ways to financially plan a retirement, but also to consider aspects that affect financial well-being during retirement, including healthcare coverage, lifestyle and traveling, legal and estate, professional development, and emotional and social support.

If you are interested in contributing or have ideas for future TNG topics, please contact me (tjudy@wustl.edu) or Danielle Kiefer (dkiefer@gastro.org), communications/managing editor of TNG.

Until next time, I leave you with a historical fun fact because we would not be where we are not without appreciating where we were: The first colonic polypectomy using an electrosurgical snare was performed by Dr. Hiromi Shinya at Beth Israel Medical Center in New York City, in 1969.
 

Yours truly,

Judy A. Trieu, MD, MPH

Editor-in-Chief

Interventional Endoscopy, Division of Gastroenterology

Washington University in St. Louis

Dear Friends,

This issue of The New Gastroenterologist marks my first year completed as faculty. It has been both the best year and the HARDEST year. I celebrated many successes, felt intellectually and emotionally drained by difficult and complicated cases, and learned that there is so much more I still do not know. But that’s the beauty of our field — we are constantly learning to be better physicians for our patients. To trainees and my fellow gastroenterologists in practice, never stop asking questions!

In this issue’s “In Focus,” Dr. Rajan Singh and Dr. Baharak Moshiree describe a practical approach to patients with bloating by evaluating and investigating the pathophysiology and etiology of bloating, such as food intolerances, visceral hypersensitivity, pelvic floor dysfunction, abdominophrenic dyssynergia, gut dysmotility, and small intestinal bacterial overgrowth, as well as treatment management. In the “Short Clinical Review” section, Dr. Ahmad Bazarbashi and his colleagues review when to refer complex polyps to an advanced endoscopist and the different techniques of advanced tissue resection, including endoscopic mucosal resection, endoscopic submucosal dissection, submucosal tunneling endoscopic resection, and full thickness resection.

Locum practices have become more popular among gastroenterologists. Dr. Catherine Bartholomew is a retired professor of medicine who was chief of gastroenterology at an academic institution, and is now working as a GI locum after retirement. She details what a locum tenens is, the role of the company, being an independent contractor, and the benefits.

Navigating and negotiating maternity and paternity leave may be challenging in private practice. Dr. Marybeth Spanarkel gives her opinion on the nuances of maternity/paternity leave in private practices, what it may mean financially, and things to inquire of the practice if planning to have children.

As we move from joining non-traditional practices and navigating family planning with private practices, Dr. Vasu Appalaneni shares her experiences with financial planning for retirement. She describes ways to financially plan a retirement, but also to consider aspects that affect financial well-being during retirement, including healthcare coverage, lifestyle and traveling, legal and estate, professional development, and emotional and social support.

If you are interested in contributing or have ideas for future TNG topics, please contact me (tjudy@wustl.edu) or Danielle Kiefer (dkiefer@gastro.org), communications/managing editor of TNG.

Until next time, I leave you with a historical fun fact because we would not be where we are not without appreciating where we were: The first colonic polypectomy using an electrosurgical snare was performed by Dr. Hiromi Shinya at Beth Israel Medical Center in New York City, in 1969.
 

Yours truly,

Judy A. Trieu, MD, MPH

Editor-in-Chief

Interventional Endoscopy, Division of Gastroenterology

Washington University in St. Louis

Dear Friends,

This issue of The New Gastroenterologist marks my first year completed as faculty. It has been both the best year and the HARDEST year. I celebrated many successes, felt intellectually and emotionally drained by difficult and complicated cases, and learned that there is so much more I still do not know. But that’s the beauty of our field — we are constantly learning to be better physicians for our patients. To trainees and my fellow gastroenterologists in practice, never stop asking questions!

In this issue’s “In Focus,” Dr. Rajan Singh and Dr. Baharak Moshiree describe a practical approach to patients with bloating by evaluating and investigating the pathophysiology and etiology of bloating, such as food intolerances, visceral hypersensitivity, pelvic floor dysfunction, abdominophrenic dyssynergia, gut dysmotility, and small intestinal bacterial overgrowth, as well as treatment management. In the “Short Clinical Review” section, Dr. Ahmad Bazarbashi and his colleagues review when to refer complex polyps to an advanced endoscopist and the different techniques of advanced tissue resection, including endoscopic mucosal resection, endoscopic submucosal dissection, submucosal tunneling endoscopic resection, and full thickness resection.

Locum practices have become more popular among gastroenterologists. Dr. Catherine Bartholomew is a retired professor of medicine who was chief of gastroenterology at an academic institution, and is now working as a GI locum after retirement. She details what a locum tenens is, the role of the company, being an independent contractor, and the benefits.

Navigating and negotiating maternity and paternity leave may be challenging in private practice. Dr. Marybeth Spanarkel gives her opinion on the nuances of maternity/paternity leave in private practices, what it may mean financially, and things to inquire of the practice if planning to have children.

As we move from joining non-traditional practices and navigating family planning with private practices, Dr. Vasu Appalaneni shares her experiences with financial planning for retirement. She describes ways to financially plan a retirement, but also to consider aspects that affect financial well-being during retirement, including healthcare coverage, lifestyle and traveling, legal and estate, professional development, and emotional and social support.

If you are interested in contributing or have ideas for future TNG topics, please contact me (tjudy@wustl.edu) or Danielle Kiefer (dkiefer@gastro.org), communications/managing editor of TNG.

Until next time, I leave you with a historical fun fact because we would not be where we are not without appreciating where we were: The first colonic polypectomy using an electrosurgical snare was performed by Dr. Hiromi Shinya at Beth Israel Medical Center in New York City, in 1969.
 

Yours truly,

Judy A. Trieu, MD, MPH

Editor-in-Chief

Interventional Endoscopy, Division of Gastroenterology

Washington University in St. Louis

This transcript has been edited for clarity. 

Hi. I’m Art Caplan. I’m at the Division of Medical Ethics at New York University Grossman School of Medicine in New York City. 

There are many things screwy with our healthcare system. Many of you [reading] this are dealing with bureaucracy, paperwork, all sorts of constraints, restraints, and requirements that sometimes make the practice of medicine, or even nursing, difficult.

I don’t think I’ve seen anything screwier, from a moral point of view, than the system we have that allows for preauthorization by third-party payers, or insurers, in order to give care to patients. It’s pretty clear that a third-party payer has a conflict of interest. It’s simple: They don’t want to spend money.

Their goal as profit-making companies is to reduce what it is that they’re going to authorize. That clearly is driving how the preauthorization process works. We’re not getting a neutral review by third parties of the appropriateness of treatment recommendations or somebody saying, this is the standard of care and this is what ought to happen.

We’re letting the people who have the pocketbooks and the wallets have prior approval of what the doctor thinks is correct. That is really not the way to practice medicine. 

We now have more evidence about what really is going on. A doctor was recently interviewed by ProPublica and said that she had worked for Cigna as a reviewer. Basically, the message she got from that insurer was to speed it up, go fast, and basically “deny, deny, deny” when she got requests. Those are her words, not mine.

We get a peek under the tent of how this works, and Dr. Day is basically saying she had to leave because she just didn’t feel that it was evidence-driven. It was driven by concerns about who’s going to lose money or make money.

If you want to check to see whether something is appropriate, the question becomes, who ought to do prior review? 

Who does it now? Sometimes doctors. Sometimes nurses who aren’t in the specialty where the request is coming in for preapproval. I’ve even seen situations where some companies use nurses in other countries, such as the Philippines, to do preapproval. They send them information, like a clip, to use to deny things that basically is boilerplate language, whatever the request is.

Looming up now, some insurers are starting to think, well, maybe artificial intelligence could do it. Just review the written request, trigger certain responses on the part of the artificial intelligence — it can deny the claims just as well as a human — and maybe it’s even cheaper to set up that system for the insurer.

This is ethically nuts. We need to have a system where doctors’ judgments drive what patients get. You listen to doctors, as I do, about preapproval access and they say patients sometimes give up trying to get what they think is needed. Continuity of care is interrupted if they have to keep making requests all the time.

There are adverse events when the thing that the doctor thought was most appropriate isn’t approved and something else is used that is less safe or less efficacious. It isn’t in patient interest to have the person with the wallet saying, this is what we think you need, and then having unqualified people or even automated intelligence with no accountability and no transparency get involved in preauthorization.

This system costs us money because middlemen are doing all this work. It basically becomes one of the huge scandals, in my view, of our health system, that doctors don’t ultimately decide what the patient needs. A preauthorizing third party or robot, without transparency, without accountability, and behind closed doors second-guesses what’s going on.

I’m Art Caplan at the Division of Medical Ethics at the New York University Grossman School of Medicine.

Arthur L. Caplan, Director, Division of Medical Ethics, New York University Langone Medical Center, New York, New York, has disclosed the following relevant financial relationships: Served as a director, officer, partner, employee, advisor, consultant, or trustee for Johnson & Johnson’s Panel for Compassionate Drug Use (unpaid position). Serves as a contributing author and advisor for Medscape.

A version of this article first appeared on Medscape.com.

This transcript has been edited for clarity. 

Hi. I’m Art Caplan. I’m at the Division of Medical Ethics at New York University Grossman School of Medicine in New York City. 

There are many things screwy with our healthcare system. Many of you [reading] this are dealing with bureaucracy, paperwork, all sorts of constraints, restraints, and requirements that sometimes make the practice of medicine, or even nursing, difficult.

I don’t think I’ve seen anything screwier, from a moral point of view, than the system we have that allows for preauthorization by third-party payers, or insurers, in order to give care to patients. It’s pretty clear that a third-party payer has a conflict of interest. It’s simple: They don’t want to spend money.

Their goal as profit-making companies is to reduce what it is that they’re going to authorize. That clearly is driving how the preauthorization process works. We’re not getting a neutral review by third parties of the appropriateness of treatment recommendations or somebody saying, this is the standard of care and this is what ought to happen.

We’re letting the people who have the pocketbooks and the wallets have prior approval of what the doctor thinks is correct. That is really not the way to practice medicine. 

We now have more evidence about what really is going on. A doctor was recently interviewed by ProPublica and said that she had worked for Cigna as a reviewer. Basically, the message she got from that insurer was to speed it up, go fast, and basically “deny, deny, deny” when she got requests. Those are her words, not mine.

We get a peek under the tent of how this works, and Dr. Day is basically saying she had to leave because she just didn’t feel that it was evidence-driven. It was driven by concerns about who’s going to lose money or make money.

If you want to check to see whether something is appropriate, the question becomes, who ought to do prior review? 

Who does it now? Sometimes doctors. Sometimes nurses who aren’t in the specialty where the request is coming in for preapproval. I’ve even seen situations where some companies use nurses in other countries, such as the Philippines, to do preapproval. They send them information, like a clip, to use to deny things that basically is boilerplate language, whatever the request is.

Looming up now, some insurers are starting to think, well, maybe artificial intelligence could do it. Just review the written request, trigger certain responses on the part of the artificial intelligence — it can deny the claims just as well as a human — and maybe it’s even cheaper to set up that system for the insurer.

This is ethically nuts. We need to have a system where doctors’ judgments drive what patients get. You listen to doctors, as I do, about preapproval access and they say patients sometimes give up trying to get what they think is needed. Continuity of care is interrupted if they have to keep making requests all the time.

There are adverse events when the thing that the doctor thought was most appropriate isn’t approved and something else is used that is less safe or less efficacious. It isn’t in patient interest to have the person with the wallet saying, this is what we think you need, and then having unqualified people or even automated intelligence with no accountability and no transparency get involved in preauthorization.

This system costs us money because middlemen are doing all this work. It basically becomes one of the huge scandals, in my view, of our health system, that doctors don’t ultimately decide what the patient needs. A preauthorizing third party or robot, without transparency, without accountability, and behind closed doors second-guesses what’s going on.

I’m Art Caplan at the Division of Medical Ethics at the New York University Grossman School of Medicine.

Arthur L. Caplan, Director, Division of Medical Ethics, New York University Langone Medical Center, New York, New York, has disclosed the following relevant financial relationships: Served as a director, officer, partner, employee, advisor, consultant, or trustee for Johnson & Johnson’s Panel for Compassionate Drug Use (unpaid position). Serves as a contributing author and advisor for Medscape.

A version of this article first appeared on Medscape.com.

This transcript has been edited for clarity. 

Hi. I’m Art Caplan. I’m at the Division of Medical Ethics at New York University Grossman School of Medicine in New York City. 

There are many things screwy with our healthcare system. Many of you [reading] this are dealing with bureaucracy, paperwork, all sorts of constraints, restraints, and requirements that sometimes make the practice of medicine, or even nursing, difficult.

I don’t think I’ve seen anything screwier, from a moral point of view, than the system we have that allows for preauthorization by third-party payers, or insurers, in order to give care to patients. It’s pretty clear that a third-party payer has a conflict of interest. It’s simple: They don’t want to spend money.

Their goal as profit-making companies is to reduce what it is that they’re going to authorize. That clearly is driving how the preauthorization process works. We’re not getting a neutral review by third parties of the appropriateness of treatment recommendations or somebody saying, this is the standard of care and this is what ought to happen.

We’re letting the people who have the pocketbooks and the wallets have prior approval of what the doctor thinks is correct. That is really not the way to practice medicine. 

We now have more evidence about what really is going on. A doctor was recently interviewed by ProPublica and said that she had worked for Cigna as a reviewer. Basically, the message she got from that insurer was to speed it up, go fast, and basically “deny, deny, deny” when she got requests. Those are her words, not mine.

We get a peek under the tent of how this works, and Dr. Day is basically saying she had to leave because she just didn’t feel that it was evidence-driven. It was driven by concerns about who’s going to lose money or make money.

If you want to check to see whether something is appropriate, the question becomes, who ought to do prior review? 

Who does it now? Sometimes doctors. Sometimes nurses who aren’t in the specialty where the request is coming in for preapproval. I’ve even seen situations where some companies use nurses in other countries, such as the Philippines, to do preapproval. They send them information, like a clip, to use to deny things that basically is boilerplate language, whatever the request is.

Looming up now, some insurers are starting to think, well, maybe artificial intelligence could do it. Just review the written request, trigger certain responses on the part of the artificial intelligence — it can deny the claims just as well as a human — and maybe it’s even cheaper to set up that system for the insurer.

This is ethically nuts. We need to have a system where doctors’ judgments drive what patients get. You listen to doctors, as I do, about preapproval access and they say patients sometimes give up trying to get what they think is needed. Continuity of care is interrupted if they have to keep making requests all the time.

There are adverse events when the thing that the doctor thought was most appropriate isn’t approved and something else is used that is less safe or less efficacious. It isn’t in patient interest to have the person with the wallet saying, this is what we think you need, and then having unqualified people or even automated intelligence with no accountability and no transparency get involved in preauthorization.

This system costs us money because middlemen are doing all this work. It basically becomes one of the huge scandals, in my view, of our health system, that doctors don’t ultimately decide what the patient needs. A preauthorizing third party or robot, without transparency, without accountability, and behind closed doors second-guesses what’s going on.

I’m Art Caplan at the Division of Medical Ethics at the New York University Grossman School of Medicine.

Arthur L. Caplan, Director, Division of Medical Ethics, New York University Langone Medical Center, New York, New York, has disclosed the following relevant financial relationships: Served as a director, officer, partner, employee, advisor, consultant, or trustee for Johnson & Johnson’s Panel for Compassionate Drug Use (unpaid position). Serves as a contributing author and advisor for Medscape.

A version of this article first appeared on Medscape.com.

A recent survey by the Pew Research Center has found that among adults younger than 50, the percentage who say they are unlikely to have children rose from 37% to 47%. With this trend freshly etched in my consciousness, I stumbled across an interview with Anastasia Berg, an assistant professor of philosophy at the University of California, Irvine. Professor Berg and Rachel Wiseman have just published What Are Children For? On Ambivalence and Choice. How could a pediatrician with time on his hands ignore a provocative title like that?

I was immediately drawn to Professor Berg’s observations about the “concerns, anxieties, and lines of reasoning people encounter when considering whether or not they should have children.” Prior to the 1960s, motherhood seemed to just be a natural progression from marriage. That’s the way my wife and I approached it when we had our first child while I was in my last year of medical school in 1971. There was no discussion of the pros and cons, except maybe that financially waiting until the eve of my first professional paycheck seemed to make sense.

However, as Professor Berg points out, from the 1960s up until well into the 1980s, as feminist thought gained a higher profile, there were anti-motherhood factions. There were others who wanted to see motherhood reformed and adapted so it “could once again be a legitimate source of meaning and value in life.” However, both camps agreed that the choice to have children was a decision that “women should make completely on their own.”

Now, well into the new millennium, we are looking at a completely different landscape. In the past, having children was woven into the fabric of human life in which we had a past, a present, and a role in creating the future. Professor Berg observes that currently, having children is often considered a project, not unlike our other projects such as “career choice or travel plans.” What are the pluses and minuses?

The Pew Survey found that 60% of adults younger than 50 who don’t have children said that not having children made it less difficult to be successful and have an active social life. Many felt that being a parent would improve the chances of having someone to care for you as you aged.

When my wife and I considered the financial costs of motherhood more than 50 years ago, our calculation was primarily about the timing. The decision to have a second child focused our concern around our ability to balance our attention between two siblings. A third child just sorta happened without any discussion.

Professor Berg echoes the Pew findings when she observes that currently woman are considering the cost in terms of their identities. Will motherhood transform me? Will there be a cost not only to my career but also to all the associations, interests, and activities I have accumulated? These costs are likely to be greater the longer the decision to have a child is put off. She adds that viewing motherhood as a transformation can make the decision to have children scarier than it needs to be. My wife and I, at age 26 and 27, were still in the early stages of building our identities. My wife had a 2-year college degree and no career plans on the horizon. Having a child was one of those things that was built into who we became.

But to compare our experiences in the 1970s to the realities of the first quarter of the 21st century ignores the concerns facing today’s adults who are facing the cloud of uncertainty hanging over all of us. Despite their claims to fix the situation, both sides of the political spectrum are leveraging fear to gain our support. Even climate change skeptics must have some concern in the spate of natural disasters we are experiencing. Not to mention the pandemic. Anxiety in this country is at an all time high. Optimism doesn’t seem to fit into today’s journalists’ lexicon, as they chose to focus on conflict instead of cooperation. It’s hard to question any adult who harbors serious doubts on taking on the challenge of parenthood and bringing a child into a world that feels unsettled.

However, based on her research and her own experience as a parent, Professor Berg offers some advice. She encourages people to think and discuss the decision to have children earlier in their life trajectory, before they have made decisions that may eventually limit their options. Second, she discourages making a list of pros and cons. Finally, she advises taking a long view and ask yourself whether you “choose to take a direct part in ushering in the next generation.”

Sounds like advice that will optimize the chances of making the good decision about having a child. I’m just thankful to have lived at time and in a situation when having child was just the thing most married couples did.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at pdnews@mdedge.com.

A recent survey by the Pew Research Center has found that among adults younger than 50, the percentage who say they are unlikely to have children rose from 37% to 47%. With this trend freshly etched in my consciousness, I stumbled across an interview with Anastasia Berg, an assistant professor of philosophy at the University of California, Irvine. Professor Berg and Rachel Wiseman have just published What Are Children For? On Ambivalence and Choice. How could a pediatrician with time on his hands ignore a provocative title like that?

I was immediately drawn to Professor Berg’s observations about the “concerns, anxieties, and lines of reasoning people encounter when considering whether or not they should have children.” Prior to the 1960s, motherhood seemed to just be a natural progression from marriage. That’s the way my wife and I approached it when we had our first child while I was in my last year of medical school in 1971. There was no discussion of the pros and cons, except maybe that financially waiting until the eve of my first professional paycheck seemed to make sense.

However, as Professor Berg points out, from the 1960s up until well into the 1980s, as feminist thought gained a higher profile, there were anti-motherhood factions. There were others who wanted to see motherhood reformed and adapted so it “could once again be a legitimate source of meaning and value in life.” However, both camps agreed that the choice to have children was a decision that “women should make completely on their own.”

Now, well into the new millennium, we are looking at a completely different landscape. In the past, having children was woven into the fabric of human life in which we had a past, a present, and a role in creating the future. Professor Berg observes that currently, having children is often considered a project, not unlike our other projects such as “career choice or travel plans.” What are the pluses and minuses?

The Pew Survey found that 60% of adults younger than 50 who don’t have children said that not having children made it less difficult to be successful and have an active social life. Many felt that being a parent would improve the chances of having someone to care for you as you aged.

When my wife and I considered the financial costs of motherhood more than 50 years ago, our calculation was primarily about the timing. The decision to have a second child focused our concern around our ability to balance our attention between two siblings. A third child just sorta happened without any discussion.

Professor Berg echoes the Pew findings when she observes that currently woman are considering the cost in terms of their identities. Will motherhood transform me? Will there be a cost not only to my career but also to all the associations, interests, and activities I have accumulated? These costs are likely to be greater the longer the decision to have a child is put off. She adds that viewing motherhood as a transformation can make the decision to have children scarier than it needs to be. My wife and I, at age 26 and 27, were still in the early stages of building our identities. My wife had a 2-year college degree and no career plans on the horizon. Having a child was one of those things that was built into who we became.

But to compare our experiences in the 1970s to the realities of the first quarter of the 21st century ignores the concerns facing today’s adults who are facing the cloud of uncertainty hanging over all of us. Despite their claims to fix the situation, both sides of the political spectrum are leveraging fear to gain our support. Even climate change skeptics must have some concern in the spate of natural disasters we are experiencing. Not to mention the pandemic. Anxiety in this country is at an all time high. Optimism doesn’t seem to fit into today’s journalists’ lexicon, as they chose to focus on conflict instead of cooperation. It’s hard to question any adult who harbors serious doubts on taking on the challenge of parenthood and bringing a child into a world that feels unsettled.

However, based on her research and her own experience as a parent, Professor Berg offers some advice. She encourages people to think and discuss the decision to have children earlier in their life trajectory, before they have made decisions that may eventually limit their options. Second, she discourages making a list of pros and cons. Finally, she advises taking a long view and ask yourself whether you “choose to take a direct part in ushering in the next generation.”

Sounds like advice that will optimize the chances of making the good decision about having a child. I’m just thankful to have lived at time and in a situation when having child was just the thing most married couples did.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at pdnews@mdedge.com.

A recent survey by the Pew Research Center has found that among adults younger than 50, the percentage who say they are unlikely to have children rose from 37% to 47%. With this trend freshly etched in my consciousness, I stumbled across an interview with Anastasia Berg, an assistant professor of philosophy at the University of California, Irvine. Professor Berg and Rachel Wiseman have just published What Are Children For? On Ambivalence and Choice. How could a pediatrician with time on his hands ignore a provocative title like that?

I was immediately drawn to Professor Berg’s observations about the “concerns, anxieties, and lines of reasoning people encounter when considering whether or not they should have children.” Prior to the 1960s, motherhood seemed to just be a natural progression from marriage. That’s the way my wife and I approached it when we had our first child while I was in my last year of medical school in 1971. There was no discussion of the pros and cons, except maybe that financially waiting until the eve of my first professional paycheck seemed to make sense.

However, as Professor Berg points out, from the 1960s up until well into the 1980s, as feminist thought gained a higher profile, there were anti-motherhood factions. There were others who wanted to see motherhood reformed and adapted so it “could once again be a legitimate source of meaning and value in life.” However, both camps agreed that the choice to have children was a decision that “women should make completely on their own.”

Now, well into the new millennium, we are looking at a completely different landscape. In the past, having children was woven into the fabric of human life in which we had a past, a present, and a role in creating the future. Professor Berg observes that currently, having children is often considered a project, not unlike our other projects such as “career choice or travel plans.” What are the pluses and minuses?

The Pew Survey found that 60% of adults younger than 50 who don’t have children said that not having children made it less difficult to be successful and have an active social life. Many felt that being a parent would improve the chances of having someone to care for you as you aged.

When my wife and I considered the financial costs of motherhood more than 50 years ago, our calculation was primarily about the timing. The decision to have a second child focused our concern around our ability to balance our attention between two siblings. A third child just sorta happened without any discussion.

Professor Berg echoes the Pew findings when she observes that currently woman are considering the cost in terms of their identities. Will motherhood transform me? Will there be a cost not only to my career but also to all the associations, interests, and activities I have accumulated? These costs are likely to be greater the longer the decision to have a child is put off. She adds that viewing motherhood as a transformation can make the decision to have children scarier than it needs to be. My wife and I, at age 26 and 27, were still in the early stages of building our identities. My wife had a 2-year college degree and no career plans on the horizon. Having a child was one of those things that was built into who we became.

But to compare our experiences in the 1970s to the realities of the first quarter of the 21st century ignores the concerns facing today’s adults who are facing the cloud of uncertainty hanging over all of us. Despite their claims to fix the situation, both sides of the political spectrum are leveraging fear to gain our support. Even climate change skeptics must have some concern in the spate of natural disasters we are experiencing. Not to mention the pandemic. Anxiety in this country is at an all time high. Optimism doesn’t seem to fit into today’s journalists’ lexicon, as they chose to focus on conflict instead of cooperation. It’s hard to question any adult who harbors serious doubts on taking on the challenge of parenthood and bringing a child into a world that feels unsettled.

However, based on her research and her own experience as a parent, Professor Berg offers some advice. She encourages people to think and discuss the decision to have children earlier in their life trajectory, before they have made decisions that may eventually limit their options. Second, she discourages making a list of pros and cons. Finally, she advises taking a long view and ask yourself whether you “choose to take a direct part in ushering in the next generation.”

Sounds like advice that will optimize the chances of making the good decision about having a child. I’m just thankful to have lived at time and in a situation when having child was just the thing most married couples did.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at pdnews@mdedge.com.

I need a hobby. Any suggestions?

Due to the annual summertime slowdown, I find myself with less to do and catch up on during weekends. My kids are grown. Nowadays, when I have free time, I have no idea what to do with myself.

That’s not to say I don’t do things to relax. Jigsaw puzzles, reading P.G. Wodehouse ... but there’s only so long I can sit there, maybe 30 minutes, before I get bored. Then I go back to my desk, check email, log in to see if any prescription refills need to be addressed ...

I look online for ideas. No, I don’t want to collect things. Or start gardening. Or learn an instrument. Or paint. Or take up photography. The last thing I want is a hobby that involves a significant financial outlay for stuff I may be selling on eBay in 3 months.

Dr. Block has a solo neurology practice in Scottsdale, Arizona.

I need a hobby. Any suggestions?

Due to the annual summertime slowdown, I find myself with less to do and catch up on during weekends. My kids are grown. Nowadays, when I have free time, I have no idea what to do with myself.

That’s not to say I don’t do things to relax. Jigsaw puzzles, reading P.G. Wodehouse ... but there’s only so long I can sit there, maybe 30 minutes, before I get bored. Then I go back to my desk, check email, log in to see if any prescription refills need to be addressed ...

I look online for ideas. No, I don’t want to collect things. Or start gardening. Or learn an instrument. Or paint. Or take up photography. The last thing I want is a hobby that involves a significant financial outlay for stuff I may be selling on eBay in 3 months.

Dr. Block has a solo neurology practice in Scottsdale, Arizona.

I need a hobby. Any suggestions?

Due to the annual summertime slowdown, I find myself with less to do and catch up on during weekends. My kids are grown. Nowadays, when I have free time, I have no idea what to do with myself.

That’s not to say I don’t do things to relax. Jigsaw puzzles, reading P.G. Wodehouse ... but there’s only so long I can sit there, maybe 30 minutes, before I get bored. Then I go back to my desk, check email, log in to see if any prescription refills need to be addressed ...

I look online for ideas. No, I don’t want to collect things. Or start gardening. Or learn an instrument. Or paint. Or take up photography. The last thing I want is a hobby that involves a significant financial outlay for stuff I may be selling on eBay in 3 months.

Dr. Block has a solo neurology practice in Scottsdale, Arizona.

Recently, a patient of mine was hospitalized with chest pain. She was diagnosed with an acute coronary syndrome and started on a statin in addition to a beta-blocker, aspirin, and clopidogrel. After discharge, she had symptoms of dizziness and recurrent chest pain and her first thought was to stop the statin because she believed that her symptoms were statin-related side effects. I will cover a few areas where I think that there are some misunderstandings about statins.

Statins Are Not Bad For the Liver

When lovastatin first became available for prescription in the 1980s, frequent monitoring of transaminases was recommended. Patients and healthcare professionals became accustomed to frequent liver tests to monitor for statin toxicity, and to this day, some healthcare professionals still obtain liver function tests for this purpose.

But is there a reason to do this? Pfeffer and colleagues reported on the results of over 112,000 people enrolled in the West of Scotland Coronary Protection trial and found that the percentage of patients with any abnormal liver function test was similar (> 3 times the upper limit of normal for ALT) for patients taking pravastatin (1.4%) and for patients taking placebo (1.4%).¹ A panel of liver experts concurred that statin-associated transaminase elevations were not indicative of liver damage or dysfunction.² Furthermore, they noted that chronic liver disease and compensated cirrhosis were not contraindications to statin use.

In a small study, use of low-dose atorvastatin in patients with nonalcoholic steatohepatitis improved transaminase values in 75% of patients and liver steatosis and nonalcoholic fatty liver disease activity scores were significantly improved on biopsy in most of the patients.³ The US Food and Drug Administration (FDA) removed the recommendation for routine regular monitoring of liver function for patients on statins in 2012.⁴

Statins Do Not Cause Muscle Pain in Most Patients

Most muscle pain occurring in patients on statins is not due to the statin although patient concerns about muscle pain are common. In a meta-analysis of 19 large statin trials, 27.1% of participants treated with a statin reported at least one episode of muscle pain or weakness during a median of 4.3 years, compared with 26.6% of participants treated with placebo.⁵ Muscle pain for any reason is common, and patients on statins may stop therapy because of the symptoms.

Cohen and colleagues performed a survey of past and current statin users, asking about muscle symptoms.⁶ Muscle-related side effects were reported by 60% of former statin users and 25% of current users.

Herrett and colleagues performed an extensive series of n-of-1 trials involving 200 patients who had stopped or were considering stopping statins because of muscle symptoms.⁷ Participants received either 2-month blocks of atorvastatin 20 mg or 2-month blocks of placebo, six times. They rated their muscle symptoms on a visual analogue scale at the end of each block. There was no difference in muscle symptom scores between the statin and placebo periods.

Wood and colleagues took it a step further when they planned an n-of-1 trial that included statin, placebo, and no treatment.⁸ Each participant received four bottles of atorvastatin 20 mg, four bottles of placebo, and four empty bottles. Each month they used treatment from the bottles based on a random sequence and reported daily symptom scores. The mean symptom intensity score was 8.0 during no-tablet months, 15.4 during placebo months (P < .001, compared with no-tablet months), and 16.3 during statin months (P < .001, compared with no-tablet months; P = .39, compared with placebo).
 

Statins Are Likely Helpful In the Very Elderly

Should we be using statins for primary prevention in our very old patients? For many years the answer was generally “no” on the basis of a lack of evidence. Patients in their 80s often were not included in clinical trials. The much used American Heart Association risk calculator stops at age 79. Given the prevalence of coronary artery disease in patients as they reach their 80s, wouldn’t primary prevention really be secondary prevention? Xu and colleagues in a recent study compared outcomes for patients who were treated with statins for primary prevention with a group who were not. In the patients aged 75-84 there was a risk reduction for major cardiovascular events of 1.2% over 5 years, and for those 85 and older the risk reduction was 4.4%. Importantly, there were no significantly increased risks for myopathies and liver dysfunction in either age group.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. He is a member of the editorial advisory board of Internal Medicine News. Dr. Paauw has no conflicts to disclose. Contact him at imnews@mdedge.com.

References

1. Pfeffer MA et al. Circulation. 2002;105(20):2341-6.

2. Cohen DE et al. Am J Cardiol. 2006;97(8A):77C-81C.

3. Hyogo H et al. Metabolism. 2008;57(12):1711-8.

4. FDA Drug Safety Communication: Important safety label changes to cholesterol-lowering statin drugs. 2012 Feb 28.

5. Cholesterol Treatment Trialists’ Collaboration. Lancet. 2022;400(10355):832-45.

6. Cohen JD et al. J Clin Lipidol. 2012;6(3):208-15.

7. Herrett E et al. BMJ. 2021 Feb 24;372:n1355.

8. Wood FA et al. N Engl J Med. 2020;383(22):2182-4.

9. Xu W et al. Ann Intern Med. 2024;177(6):701-10.

Recently, a patient of mine was hospitalized with chest pain. She was diagnosed with an acute coronary syndrome and started on a statin in addition to a beta-blocker, aspirin, and clopidogrel. After discharge, she had symptoms of dizziness and recurrent chest pain and her first thought was to stop the statin because she believed that her symptoms were statin-related side effects. I will cover a few areas where I think that there are some misunderstandings about statins.

Statins Are Not Bad For the Liver

When lovastatin first became available for prescription in the 1980s, frequent monitoring of transaminases was recommended. Patients and healthcare professionals became accustomed to frequent liver tests to monitor for statin toxicity, and to this day, some healthcare professionals still obtain liver function tests for this purpose.

But is there a reason to do this? Pfeffer and colleagues reported on the results of over 112,000 people enrolled in the West of Scotland Coronary Protection trial and found that the percentage of patients with any abnormal liver function test was similar (> 3 times the upper limit of normal for ALT) for patients taking pravastatin (1.4%) and for patients taking placebo (1.4%).¹ A panel of liver experts concurred that statin-associated transaminase elevations were not indicative of liver damage or dysfunction.² Furthermore, they noted that chronic liver disease and compensated cirrhosis were not contraindications to statin use.

In a small study, use of low-dose atorvastatin in patients with nonalcoholic steatohepatitis improved transaminase values in 75% of patients and liver steatosis and nonalcoholic fatty liver disease activity scores were significantly improved on biopsy in most of the patients.³ The US Food and Drug Administration (FDA) removed the recommendation for routine regular monitoring of liver function for patients on statins in 2012.⁴

Statins Do Not Cause Muscle Pain in Most Patients

Most muscle pain occurring in patients on statins is not due to the statin although patient concerns about muscle pain are common. In a meta-analysis of 19 large statin trials, 27.1% of participants treated with a statin reported at least one episode of muscle pain or weakness during a median of 4.3 years, compared with 26.6% of participants treated with placebo.⁵ Muscle pain for any reason is common, and patients on statins may stop therapy because of the symptoms.

Cohen and colleagues performed a survey of past and current statin users, asking about muscle symptoms.⁶ Muscle-related side effects were reported by 60% of former statin users and 25% of current users.

Herrett and colleagues performed an extensive series of n-of-1 trials involving 200 patients who had stopped or were considering stopping statins because of muscle symptoms.⁷ Participants received either 2-month blocks of atorvastatin 20 mg or 2-month blocks of placebo, six times. They rated their muscle symptoms on a visual analogue scale at the end of each block. There was no difference in muscle symptom scores between the statin and placebo periods.

Wood and colleagues took it a step further when they planned an n-of-1 trial that included statin, placebo, and no treatment.⁸ Each participant received four bottles of atorvastatin 20 mg, four bottles of placebo, and four empty bottles. Each month they used treatment from the bottles based on a random sequence and reported daily symptom scores. The mean symptom intensity score was 8.0 during no-tablet months, 15.4 during placebo months (P < .001, compared with no-tablet months), and 16.3 during statin months (P < .001, compared with no-tablet months; P = .39, compared with placebo).
 

Statins Are Likely Helpful In the Very Elderly

Should we be using statins for primary prevention in our very old patients? For many years the answer was generally “no” on the basis of a lack of evidence. Patients in their 80s often were not included in clinical trials. The much used American Heart Association risk calculator stops at age 79. Given the prevalence of coronary artery disease in patients as they reach their 80s, wouldn’t primary prevention really be secondary prevention? Xu and colleagues in a recent study compared outcomes for patients who were treated with statins for primary prevention with a group who were not. In the patients aged 75-84 there was a risk reduction for major cardiovascular events of 1.2% over 5 years, and for those 85 and older the risk reduction was 4.4%. Importantly, there were no significantly increased risks for myopathies and liver dysfunction in either age group.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. He is a member of the editorial advisory board of Internal Medicine News. Dr. Paauw has no conflicts to disclose. Contact him at imnews@mdedge.com.

References

1. Pfeffer MA et al. Circulation. 2002;105(20):2341-6.

2. Cohen DE et al. Am J Cardiol. 2006;97(8A):77C-81C.

3. Hyogo H et al. Metabolism. 2008;57(12):1711-8.

4. FDA Drug Safety Communication: Important safety label changes to cholesterol-lowering statin drugs. 2012 Feb 28.

5. Cholesterol Treatment Trialists’ Collaboration. Lancet. 2022;400(10355):832-45.

6. Cohen JD et al. J Clin Lipidol. 2012;6(3):208-15.

7. Herrett E et al. BMJ. 2021 Feb 24;372:n1355.

8. Wood FA et al. N Engl J Med. 2020;383(22):2182-4.

9. Xu W et al. Ann Intern Med. 2024;177(6):701-10.

Recently, a patient of mine was hospitalized with chest pain. She was diagnosed with an acute coronary syndrome and started on a statin in addition to a beta-blocker, aspirin, and clopidogrel. After discharge, she had symptoms of dizziness and recurrent chest pain and her first thought was to stop the statin because she believed that her symptoms were statin-related side effects. I will cover a few areas where I think that there are some misunderstandings about statins.

Statins Are Not Bad For the Liver

When lovastatin first became available for prescription in the 1980s, frequent monitoring of transaminases was recommended. Patients and healthcare professionals became accustomed to frequent liver tests to monitor for statin toxicity, and to this day, some healthcare professionals still obtain liver function tests for this purpose.

But is there a reason to do this? Pfeffer and colleagues reported on the results of over 112,000 people enrolled in the West of Scotland Coronary Protection trial and found that the percentage of patients with any abnormal liver function test was similar (> 3 times the upper limit of normal for ALT) for patients taking pravastatin (1.4%) and for patients taking placebo (1.4%).¹ A panel of liver experts concurred that statin-associated transaminase elevations were not indicative of liver damage or dysfunction.² Furthermore, they noted that chronic liver disease and compensated cirrhosis were not contraindications to statin use.

In a small study, use of low-dose atorvastatin in patients with nonalcoholic steatohepatitis improved transaminase values in 75% of patients and liver steatosis and nonalcoholic fatty liver disease activity scores were significantly improved on biopsy in most of the patients.³ The US Food and Drug Administration (FDA) removed the recommendation for routine regular monitoring of liver function for patients on statins in 2012.⁴

Statins Do Not Cause Muscle Pain in Most Patients

Most muscle pain occurring in patients on statins is not due to the statin although patient concerns about muscle pain are common. In a meta-analysis of 19 large statin trials, 27.1% of participants treated with a statin reported at least one episode of muscle pain or weakness during a median of 4.3 years, compared with 26.6% of participants treated with placebo.⁵ Muscle pain for any reason is common, and patients on statins may stop therapy because of the symptoms.

Cohen and colleagues performed a survey of past and current statin users, asking about muscle symptoms.⁶ Muscle-related side effects were reported by 60% of former statin users and 25% of current users.

Herrett and colleagues performed an extensive series of n-of-1 trials involving 200 patients who had stopped or were considering stopping statins because of muscle symptoms.⁷ Participants received either 2-month blocks of atorvastatin 20 mg or 2-month blocks of placebo, six times. They rated their muscle symptoms on a visual analogue scale at the end of each block. There was no difference in muscle symptom scores between the statin and placebo periods.

Wood and colleagues took it a step further when they planned an n-of-1 trial that included statin, placebo, and no treatment.⁸ Each participant received four bottles of atorvastatin 20 mg, four bottles of placebo, and four empty bottles. Each month they used treatment from the bottles based on a random sequence and reported daily symptom scores. The mean symptom intensity score was 8.0 during no-tablet months, 15.4 during placebo months (P < .001, compared with no-tablet months), and 16.3 during statin months (P < .001, compared with no-tablet months; P = .39, compared with placebo).
 

Statins Are Likely Helpful In the Very Elderly

Should we be using statins for primary prevention in our very old patients? For many years the answer was generally “no” on the basis of a lack of evidence. Patients in their 80s often were not included in clinical trials. The much used American Heart Association risk calculator stops at age 79. Given the prevalence of coronary artery disease in patients as they reach their 80s, wouldn’t primary prevention really be secondary prevention? Xu and colleagues in a recent study compared outcomes for patients who were treated with statins for primary prevention with a group who were not. In the patients aged 75-84 there was a risk reduction for major cardiovascular events of 1.2% over 5 years, and for those 85 and older the risk reduction was 4.4%. Importantly, there were no significantly increased risks for myopathies and liver dysfunction in either age group.

Dr. Paauw is professor of medicine in the division of general internal medicine at the University of Washington, Seattle, and he serves as third-year medical student clerkship director at the University of Washington. He is a member of the editorial advisory board of Internal Medicine News. Dr. Paauw has no conflicts to disclose. Contact him at imnews@mdedge.com.

References

1. Pfeffer MA et al. Circulation. 2002;105(20):2341-6.

2. Cohen DE et al. Am J Cardiol. 2006;97(8A):77C-81C.

3. Hyogo H et al. Metabolism. 2008;57(12):1711-8.

4. FDA Drug Safety Communication: Important safety label changes to cholesterol-lowering statin drugs. 2012 Feb 28.

5. Cholesterol Treatment Trialists’ Collaboration. Lancet. 2022;400(10355):832-45.

6. Cohen JD et al. J Clin Lipidol. 2012;6(3):208-15.

7. Herrett E et al. BMJ. 2021 Feb 24;372:n1355.

8. Wood FA et al. N Engl J Med. 2020;383(22):2182-4.

9. Xu W et al. Ann Intern Med. 2024;177(6):701-10.

Patients are overdosing on compounded semaglutide due to errors in measuring and self-administering the drug and due to clinicians miscalculating doses that may differ from US Food and Drug Administration (FDA)–approved products.

The FDA published an alert on July 26 after receiving reports of dosing errors involving compounded semaglutide injectable products dispensed in multidose vials. Adverse events included gastrointestinal effects, fainting, dehydration, headache, gallstones, and acute pancreatitis. Some patients required hospitalization.
 

Why the Risks?

FDA-approved semaglutide injectable products are dosed in milligrams, have standard concentrations, and are currently only available in prefilled pens.

Compounded semaglutide products may differ from approved products in ways that contribute to potential errors — for example, in multidose vials and prefilled syringes. In addition, product concentrations may vary depending on the compounder, and even a single compounder may offer multiple concentrations of semaglutide.

Instructions for a compounded drug, if provided, may tell users to administer semaglutide injections in “units,” the volume of which may vary depending on the concentration — rather than in milligrams. In some instances, patients received syringes significantly larger than the prescribed volume.
 

Common Errors

The FDA has received reports related to patients mistakenly taking more than the prescribed dose from a multidose vial — sometimes 5-20 times more than the intended dose.

Several reports described clinicians incorrectly calculating the intended dose when converting from milligrams to units or milliliters. In one case, a patient couldn’t get clarity on dosing instructions from the telemedicine provider who prescribed the compounded semaglutide, leading the patient to search online for medical advice. This resulted in the patient taking five times the intended dose.

In another example, one clinician prescribed 20 units instead of two units, affecting three patients who, after receiving 10 times the intended dose, experienced nausea and vomiting.

Another clinician, who also takes semaglutide himself, tried to recalculate his own dose in units and ended up self-administering a dose 10 times higher than intended.

The FDA previously warned about potential risks from the use of compounded drugs during a shortage as is the case with semaglutide. While compounded drugs can “sometimes” be helpful, according to the agency, “compounded drugs pose a higher risk to patients than FDA-approved drugs because compounded drugs do not undergo FDA premarket review for safety, effectiveness, or quality.”

Patients are overdosing on compounded semaglutide due to errors in measuring and self-administering the drug and due to clinicians miscalculating doses that may differ from US Food and Drug Administration (FDA)–approved products.

The FDA published an alert on July 26 after receiving reports of dosing errors involving compounded semaglutide injectable products dispensed in multidose vials. Adverse events included gastrointestinal effects, fainting, dehydration, headache, gallstones, and acute pancreatitis. Some patients required hospitalization.
 

Why the Risks?

FDA-approved semaglutide injectable products are dosed in milligrams, have standard concentrations, and are currently only available in prefilled pens.

Compounded semaglutide products may differ from approved products in ways that contribute to potential errors — for example, in multidose vials and prefilled syringes. In addition, product concentrations may vary depending on the compounder, and even a single compounder may offer multiple concentrations of semaglutide.

Instructions for a compounded drug, if provided, may tell users to administer semaglutide injections in “units,” the volume of which may vary depending on the concentration — rather than in milligrams. In some instances, patients received syringes significantly larger than the prescribed volume.
 

Common Errors

The FDA has received reports related to patients mistakenly taking more than the prescribed dose from a multidose vial — sometimes 5-20 times more than the intended dose.

Several reports described clinicians incorrectly calculating the intended dose when converting from milligrams to units or milliliters. In one case, a patient couldn’t get clarity on dosing instructions from the telemedicine provider who prescribed the compounded semaglutide, leading the patient to search online for medical advice. This resulted in the patient taking five times the intended dose.

In another example, one clinician prescribed 20 units instead of two units, affecting three patients who, after receiving 10 times the intended dose, experienced nausea and vomiting.

Another clinician, who also takes semaglutide himself, tried to recalculate his own dose in units and ended up self-administering a dose 10 times higher than intended.

The FDA previously warned about potential risks from the use of compounded drugs during a shortage as is the case with semaglutide. While compounded drugs can “sometimes” be helpful, according to the agency, “compounded drugs pose a higher risk to patients than FDA-approved drugs because compounded drugs do not undergo FDA premarket review for safety, effectiveness, or quality.”

Patients are overdosing on compounded semaglutide due to errors in measuring and self-administering the drug and due to clinicians miscalculating doses that may differ from US Food and Drug Administration (FDA)–approved products.

The FDA published an alert on July 26 after receiving reports of dosing errors involving compounded semaglutide injectable products dispensed in multidose vials. Adverse events included gastrointestinal effects, fainting, dehydration, headache, gallstones, and acute pancreatitis. Some patients required hospitalization.
 

Why the Risks?

FDA-approved semaglutide injectable products are dosed in milligrams, have standard concentrations, and are currently only available in prefilled pens.

Compounded semaglutide products may differ from approved products in ways that contribute to potential errors — for example, in multidose vials and prefilled syringes. In addition, product concentrations may vary depending on the compounder, and even a single compounder may offer multiple concentrations of semaglutide.

Instructions for a compounded drug, if provided, may tell users to administer semaglutide injections in “units,” the volume of which may vary depending on the concentration — rather than in milligrams. In some instances, patients received syringes significantly larger than the prescribed volume.
 

Common Errors

The FDA has received reports related to patients mistakenly taking more than the prescribed dose from a multidose vial — sometimes 5-20 times more than the intended dose.

Several reports described clinicians incorrectly calculating the intended dose when converting from milligrams to units or milliliters. In one case, a patient couldn’t get clarity on dosing instructions from the telemedicine provider who prescribed the compounded semaglutide, leading the patient to search online for medical advice. This resulted in the patient taking five times the intended dose.

In another example, one clinician prescribed 20 units instead of two units, affecting three patients who, after receiving 10 times the intended dose, experienced nausea and vomiting.

Another clinician, who also takes semaglutide himself, tried to recalculate his own dose in units and ended up self-administering a dose 10 times higher than intended.

The FDA previously warned about potential risks from the use of compounded drugs during a shortage as is the case with semaglutide. While compounded drugs can “sometimes” be helpful, according to the agency, “compounded drugs pose a higher risk to patients than FDA-approved drugs because compounded drugs do not undergo FDA premarket review for safety, effectiveness, or quality.”

This transcript has been edited for clarity.

Tardive dyskinesia is a chronic, potentially irreversible, hyperkinetic movement disorder. And the challenge with tardive dyskinesia is that it’s underdiagnosed and undertreated. With the expanded use of dopamine receptor–blocking agents, there are about 7.5 million Americans who are now exposed and at risk for tardive dyskinesia.

It’s thought that about 500,000-750,000 of these patients may in fact have tardive dyskinesia, but only 15% are treated. So why are people not being treated for tardive dyskinesia? Well, there are a number of possible answers.

Until a few years ago, there were no Food and Drug Administration (FDA)–approved treatments for tardive dyskinesia, and these antipsychotic medications that the patients were taking, in many cases, were potentially lifesaving drugs, so they couldn’t simply be stopped. As a result of that, I think physicians developed a certain psychic blindness to identifying tardive dyskinesia, because it was their drugs that were causing the disease and yet they couldn’t be stopped. So, there really wasn’t much they could do in terms of making the diagnosis.

In addition, they were trained that tardive dyskinesia doesn’t have much impact on patients. But we now know, through surveys and other studies, that tardive dyskinesia can have a tremendous impact on patients and on your ability to treat the patient’s underlying mental health issues. It’s estimated that 50% of patients with tardive dyskinesia actually reduce the amount of antipsychotic medication they’re taking on their own, and about 40% may in fact stop their antipsychotic medication altogether.

Thirty-five percent of patients stopped seeing their doctor after they developed tardive dyskinesia, and about 20% of patients actually told other patients not to take their antipsychotic medication. So, tardive dyskinesia is impacting your ability to treat patients. In addition, it impacts the patients themselves. Nearly three out of four patients with tardive dyskinesia said, in surveys, that it caused severe impact on their psychosocial functioning.

It also impacted caregivers, with 70% of caregivers saying that the patients with tardive dyskinesia made them more anxious and limited them socially. So, we have this tremendous impact from tardive dyskinesia.

In addition, physicians sometimes don’t identify tardive dyskinesia correctly. They mistake it for another movement disorder: drug-induced parkinsonism. Or it falls under the rubric of extrapyramidal symptoms (EPS), and they were trained that you treat EPS with benztropine. The challenge with that is that benztropine is only indicated for acute dystonia or for drug-induced parkinsonism. It actually makes tardive dyskinesia worse. And, in the product insert for benztropine, it’s recommended that it should not be used in tardive dyskinesia. So if you have a patient whom you suspect has tardive dyskinesia, you have to discontinue the benztropine. That’s a really important first step.

And then, what else should you do? There are now two FDA-approved treatments for tardive dyskinesia. These are valbenazine and deutetrabenazine. Both of these drugs have been demonstrated in large double-blind, placebo-controlled studies to reduce tardive dyskinesia, as measured by the Abnormal Involuntary Movement Scale, by about 30%. These drugs have been demonstrated to be safe and well tolerated, with the main side effect being somnolence.

Some people can also develop parkinsonism. Why could there be Parkinsonism? This is because vesicular monoamine transporter 2 (VMAT2) inhibitors work by reducing the amount of dopamine that can be packaged in the presynaptic neuron. That means that less dopamine is available to the synapse, and this reduces movement. The American Psychiatric Association has issued guidelines for the treatment of tardive dyskinesia and has said that moderate to severe tardive dyskinesia should be treated first-line with VMAT2 inhibitors and that mild tardive dyskinesia should also be treated with VMAT2 inhibitors if the tardive dyskinesia is impacting the patient.

Given the impact that tardive dyskinesia has on patients and caregivers, and the physician’s ability to treat these patients’ mental health issues, we need to become aggressive and treat the tardive dyskinesia so that patients can improve and be able to have their movements treated without impacting their underlying mental health issues.

Daniel Kremens, professor, Department of Neurology, Sidney Kimmel Medical College, Thomas Jefferson University, codirector, Parkinson’s Disease and Movement Disorders Division, Jack and Vickie Farber Center for Neuroscience, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, has disclosed relevant financial relationships with Teva Pharmaceuticals, AbbVie, Merz, Allergan, Bial, Cerevel, Amneal, Acadia, Supernus, Adamas, Acorda, Kyowa Kirin, and Neurocrine.

A version of this article first appeared on Medscape.com.

This transcript has been edited for clarity.

Tardive dyskinesia is a chronic, potentially irreversible, hyperkinetic movement disorder. And the challenge with tardive dyskinesia is that it’s underdiagnosed and undertreated. With the expanded use of dopamine receptor–blocking agents, there are about 7.5 million Americans who are now exposed and at risk for tardive dyskinesia.

It’s thought that about 500,000-750,000 of these patients may in fact have tardive dyskinesia, but only 15% are treated. So why are people not being treated for tardive dyskinesia? Well, there are a number of possible answers.

Until a few years ago, there were no Food and Drug Administration (FDA)–approved treatments for tardive dyskinesia, and these antipsychotic medications that the patients were taking, in many cases, were potentially lifesaving drugs, so they couldn’t simply be stopped. As a result of that, I think physicians developed a certain psychic blindness to identifying tardive dyskinesia, because it was their drugs that were causing the disease and yet they couldn’t be stopped. So, there really wasn’t much they could do in terms of making the diagnosis.

In addition, they were trained that tardive dyskinesia doesn’t have much impact on patients. But we now know, through surveys and other studies, that tardive dyskinesia can have a tremendous impact on patients and on your ability to treat the patient’s underlying mental health issues. It’s estimated that 50% of patients with tardive dyskinesia actually reduce the amount of antipsychotic medication they’re taking on their own, and about 40% may in fact stop their antipsychotic medication altogether.

Thirty-five percent of patients stopped seeing their doctor after they developed tardive dyskinesia, and about 20% of patients actually told other patients not to take their antipsychotic medication. So, tardive dyskinesia is impacting your ability to treat patients. In addition, it impacts the patients themselves. Nearly three out of four patients with tardive dyskinesia said, in surveys, that it caused severe impact on their psychosocial functioning.

It also impacted caregivers, with 70% of caregivers saying that the patients with tardive dyskinesia made them more anxious and limited them socially. So, we have this tremendous impact from tardive dyskinesia.

In addition, physicians sometimes don’t identify tardive dyskinesia correctly. They mistake it for another movement disorder: drug-induced parkinsonism. Or it falls under the rubric of extrapyramidal symptoms (EPS), and they were trained that you treat EPS with benztropine. The challenge with that is that benztropine is only indicated for acute dystonia or for drug-induced parkinsonism. It actually makes tardive dyskinesia worse. And, in the product insert for benztropine, it’s recommended that it should not be used in tardive dyskinesia. So if you have a patient whom you suspect has tardive dyskinesia, you have to discontinue the benztropine. That’s a really important first step.

And then, what else should you do? There are now two FDA-approved treatments for tardive dyskinesia. These are valbenazine and deutetrabenazine. Both of these drugs have been demonstrated in large double-blind, placebo-controlled studies to reduce tardive dyskinesia, as measured by the Abnormal Involuntary Movement Scale, by about 30%. These drugs have been demonstrated to be safe and well tolerated, with the main side effect being somnolence.

Some people can also develop parkinsonism. Why could there be Parkinsonism? This is because vesicular monoamine transporter 2 (VMAT2) inhibitors work by reducing the amount of dopamine that can be packaged in the presynaptic neuron. That means that less dopamine is available to the synapse, and this reduces movement. The American Psychiatric Association has issued guidelines for the treatment of tardive dyskinesia and has said that moderate to severe tardive dyskinesia should be treated first-line with VMAT2 inhibitors and that mild tardive dyskinesia should also be treated with VMAT2 inhibitors if the tardive dyskinesia is impacting the patient.

Given the impact that tardive dyskinesia has on patients and caregivers, and the physician’s ability to treat these patients’ mental health issues, we need to become aggressive and treat the tardive dyskinesia so that patients can improve and be able to have their movements treated without impacting their underlying mental health issues.

Daniel Kremens, professor, Department of Neurology, Sidney Kimmel Medical College, Thomas Jefferson University, codirector, Parkinson’s Disease and Movement Disorders Division, Jack and Vickie Farber Center for Neuroscience, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, has disclosed relevant financial relationships with Teva Pharmaceuticals, AbbVie, Merz, Allergan, Bial, Cerevel, Amneal, Acadia, Supernus, Adamas, Acorda, Kyowa Kirin, and Neurocrine.

A version of this article first appeared on Medscape.com.

This transcript has been edited for clarity.

Tardive dyskinesia is a chronic, potentially irreversible, hyperkinetic movement disorder. And the challenge with tardive dyskinesia is that it’s underdiagnosed and undertreated. With the expanded use of dopamine receptor–blocking agents, there are about 7.5 million Americans who are now exposed and at risk for tardive dyskinesia.

It’s thought that about 500,000-750,000 of these patients may in fact have tardive dyskinesia, but only 15% are treated. So why are people not being treated for tardive dyskinesia? Well, there are a number of possible answers.

Until a few years ago, there were no Food and Drug Administration (FDA)–approved treatments for tardive dyskinesia, and these antipsychotic medications that the patients were taking, in many cases, were potentially lifesaving drugs, so they couldn’t simply be stopped. As a result of that, I think physicians developed a certain psychic blindness to identifying tardive dyskinesia, because it was their drugs that were causing the disease and yet they couldn’t be stopped. So, there really wasn’t much they could do in terms of making the diagnosis.

In addition, they were trained that tardive dyskinesia doesn’t have much impact on patients. But we now know, through surveys and other studies, that tardive dyskinesia can have a tremendous impact on patients and on your ability to treat the patient’s underlying mental health issues. It’s estimated that 50% of patients with tardive dyskinesia actually reduce the amount of antipsychotic medication they’re taking on their own, and about 40% may in fact stop their antipsychotic medication altogether.

Thirty-five percent of patients stopped seeing their doctor after they developed tardive dyskinesia, and about 20% of patients actually told other patients not to take their antipsychotic medication. So, tardive dyskinesia is impacting your ability to treat patients. In addition, it impacts the patients themselves. Nearly three out of four patients with tardive dyskinesia said, in surveys, that it caused severe impact on their psychosocial functioning.

It also impacted caregivers, with 70% of caregivers saying that the patients with tardive dyskinesia made them more anxious and limited them socially. So, we have this tremendous impact from tardive dyskinesia.

In addition, physicians sometimes don’t identify tardive dyskinesia correctly. They mistake it for another movement disorder: drug-induced parkinsonism. Or it falls under the rubric of extrapyramidal symptoms (EPS), and they were trained that you treat EPS with benztropine. The challenge with that is that benztropine is only indicated for acute dystonia or for drug-induced parkinsonism. It actually makes tardive dyskinesia worse. And, in the product insert for benztropine, it’s recommended that it should not be used in tardive dyskinesia. So if you have a patient whom you suspect has tardive dyskinesia, you have to discontinue the benztropine. That’s a really important first step.

And then, what else should you do? There are now two FDA-approved treatments for tardive dyskinesia. These are valbenazine and deutetrabenazine. Both of these drugs have been demonstrated in large double-blind, placebo-controlled studies to reduce tardive dyskinesia, as measured by the Abnormal Involuntary Movement Scale, by about 30%. These drugs have been demonstrated to be safe and well tolerated, with the main side effect being somnolence.

Some people can also develop parkinsonism. Why could there be Parkinsonism? This is because vesicular monoamine transporter 2 (VMAT2) inhibitors work by reducing the amount of dopamine that can be packaged in the presynaptic neuron. That means that less dopamine is available to the synapse, and this reduces movement. The American Psychiatric Association has issued guidelines for the treatment of tardive dyskinesia and has said that moderate to severe tardive dyskinesia should be treated first-line with VMAT2 inhibitors and that mild tardive dyskinesia should also be treated with VMAT2 inhibitors if the tardive dyskinesia is impacting the patient.

Given the impact that tardive dyskinesia has on patients and caregivers, and the physician’s ability to treat these patients’ mental health issues, we need to become aggressive and treat the tardive dyskinesia so that patients can improve and be able to have their movements treated without impacting their underlying mental health issues.

Daniel Kremens, professor, Department of Neurology, Sidney Kimmel Medical College, Thomas Jefferson University, codirector, Parkinson’s Disease and Movement Disorders Division, Jack and Vickie Farber Center for Neuroscience, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania, has disclosed relevant financial relationships with Teva Pharmaceuticals, AbbVie, Merz, Allergan, Bial, Cerevel, Amneal, Acadia, Supernus, Adamas, Acorda, Kyowa Kirin, and Neurocrine.

A version of this article first appeared on Medscape.com.