Ob.Gyn. News

TOPLINE:

Young and adult children of mothers with type 1 diabetes are almost half as likely be diagnosed with this condition compared with those with affected fathers, even with a similar genetic risk score. 

METHODOLOGY:

• Individuals with a family history of type 1 diabetes face 8-15 times higher risk for this condition than the general population, with the risk of inheritance from mothers with type 1 diabetes being about half that of fathers with type 1 diabetes; however, it is unclear if the effect continues past childhood and what is responsible for the difference in risk.
• Researchers performed a meta-analysis across five cohort studies involving 11,475 individuals diagnosed with type 1 diabetes aged 0-88 years to evaluate if maternal type 1 diabetes conferred relative protection only to young children.
• They compared the proportion of individuals with type 1 diabetes with affected fathers versus mothers and explored if this comparison was altered by the age at diagnosis and the timing of parental diagnosis relative to the birth of the offspring.
• Lastly, the inherited genetic risk for type 1 diabetes was compared between those with affected mothers versus fathers using a risk score composed of more than 60 different gene variants associated with type 1 diabetes.

TAKEAWAY:

• Individuals with type 1 diabetes were almost twice as likely to have a father with the condition than a mother (odds ratio, 1.79; P < .0001).
• The protective effect of maternal diabetes was seen regardless of whether the individuals were diagnosed with type 1 diabetes before or after age 18 years (P < .0001).
• Maternal diabetes was linked to a lower risk for type 1 diabetes in children only if the mother had type 1 diabetes during pregnancy.
• The genetic risk score for type 1 diabetes was not significantly different between those with affected fathers versus mothers (P = .31).

IN PRACTICE:

“Understanding why having a mother compared with a father with type 1 diabetes offers a relative protection against type 1 diabetes could help us develop new ways to prevent type 1 diabetes, such as treatments that mimic some of the protective elements from mothers,” study author Lowri Allen, MBChB, said in a news release.

SOURCE:

The study was led by Dr. Allen from the Diabetes Research Group, Cardiff University, Cardiff, Wales, and was published as an early release from the annual meeting of the European Association for the Study of Diabetes. 

LIMITATIONS:

This abstract did not discuss any limitations. The number of individuals and parents with type 1 diabetes in the meta-analysis was not disclosed. The baseline risk for type 1 diabetes among individuals with a mother, father, or both or no parent with type 1 diabetes was not disclosed. The number of people with type 1 diabetes under and over age 18 was not disclosed, nor were the numbers of mothers and fathers with type 1 diabetes. The relative risk in individuals having no parent with type 1 diabetes was not disclosed. Moreover, the race and ethnicity of the study populations were not disclosed. 

DISCLOSURES:

The Wellcome Trust supported this study. The authors declared no relevant conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Young and adult children of mothers with type 1 diabetes are almost half as likely be diagnosed with this condition compared with those with affected fathers, even with a similar genetic risk score. 

METHODOLOGY:

• Individuals with a family history of type 1 diabetes face 8-15 times higher risk for this condition than the general population, with the risk of inheritance from mothers with type 1 diabetes being about half that of fathers with type 1 diabetes; however, it is unclear if the effect continues past childhood and what is responsible for the difference in risk.
• Researchers performed a meta-analysis across five cohort studies involving 11,475 individuals diagnosed with type 1 diabetes aged 0-88 years to evaluate if maternal type 1 diabetes conferred relative protection only to young children.
• They compared the proportion of individuals with type 1 diabetes with affected fathers versus mothers and explored if this comparison was altered by the age at diagnosis and the timing of parental diagnosis relative to the birth of the offspring.
• Lastly, the inherited genetic risk for type 1 diabetes was compared between those with affected mothers versus fathers using a risk score composed of more than 60 different gene variants associated with type 1 diabetes.

TAKEAWAY:

• Individuals with type 1 diabetes were almost twice as likely to have a father with the condition than a mother (odds ratio, 1.79; P < .0001).
• The protective effect of maternal diabetes was seen regardless of whether the individuals were diagnosed with type 1 diabetes before or after age 18 years (P < .0001).
• Maternal diabetes was linked to a lower risk for type 1 diabetes in children only if the mother had type 1 diabetes during pregnancy.
• The genetic risk score for type 1 diabetes was not significantly different between those with affected fathers versus mothers (P = .31).

IN PRACTICE:

“Understanding why having a mother compared with a father with type 1 diabetes offers a relative protection against type 1 diabetes could help us develop new ways to prevent type 1 diabetes, such as treatments that mimic some of the protective elements from mothers,” study author Lowri Allen, MBChB, said in a news release.

SOURCE:

The study was led by Dr. Allen from the Diabetes Research Group, Cardiff University, Cardiff, Wales, and was published as an early release from the annual meeting of the European Association for the Study of Diabetes. 

LIMITATIONS:

This abstract did not discuss any limitations. The number of individuals and parents with type 1 diabetes in the meta-analysis was not disclosed. The baseline risk for type 1 diabetes among individuals with a mother, father, or both or no parent with type 1 diabetes was not disclosed. The number of people with type 1 diabetes under and over age 18 was not disclosed, nor were the numbers of mothers and fathers with type 1 diabetes. The relative risk in individuals having no parent with type 1 diabetes was not disclosed. Moreover, the race and ethnicity of the study populations were not disclosed. 

DISCLOSURES:

The Wellcome Trust supported this study. The authors declared no relevant conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Young and adult children of mothers with type 1 diabetes are almost half as likely be diagnosed with this condition compared with those with affected fathers, even with a similar genetic risk score. 

METHODOLOGY:

• Individuals with a family history of type 1 diabetes face 8-15 times higher risk for this condition than the general population, with the risk of inheritance from mothers with type 1 diabetes being about half that of fathers with type 1 diabetes; however, it is unclear if the effect continues past childhood and what is responsible for the difference in risk.
• Researchers performed a meta-analysis across five cohort studies involving 11,475 individuals diagnosed with type 1 diabetes aged 0-88 years to evaluate if maternal type 1 diabetes conferred relative protection only to young children.
• They compared the proportion of individuals with type 1 diabetes with affected fathers versus mothers and explored if this comparison was altered by the age at diagnosis and the timing of parental diagnosis relative to the birth of the offspring.
• Lastly, the inherited genetic risk for type 1 diabetes was compared between those with affected mothers versus fathers using a risk score composed of more than 60 different gene variants associated with type 1 diabetes.

TAKEAWAY:

• Individuals with type 1 diabetes were almost twice as likely to have a father with the condition than a mother (odds ratio, 1.79; P < .0001).
• The protective effect of maternal diabetes was seen regardless of whether the individuals were diagnosed with type 1 diabetes before or after age 18 years (P < .0001).
• Maternal diabetes was linked to a lower risk for type 1 diabetes in children only if the mother had type 1 diabetes during pregnancy.
• The genetic risk score for type 1 diabetes was not significantly different between those with affected fathers versus mothers (P = .31).

IN PRACTICE:

“Understanding why having a mother compared with a father with type 1 diabetes offers a relative protection against type 1 diabetes could help us develop new ways to prevent type 1 diabetes, such as treatments that mimic some of the protective elements from mothers,” study author Lowri Allen, MBChB, said in a news release.

SOURCE:

The study was led by Dr. Allen from the Diabetes Research Group, Cardiff University, Cardiff, Wales, and was published as an early release from the annual meeting of the European Association for the Study of Diabetes. 

LIMITATIONS:

This abstract did not discuss any limitations. The number of individuals and parents with type 1 diabetes in the meta-analysis was not disclosed. The baseline risk for type 1 diabetes among individuals with a mother, father, or both or no parent with type 1 diabetes was not disclosed. The number of people with type 1 diabetes under and over age 18 was not disclosed, nor were the numbers of mothers and fathers with type 1 diabetes. The relative risk in individuals having no parent with type 1 diabetes was not disclosed. Moreover, the race and ethnicity of the study populations were not disclosed. 

DISCLOSURES:

The Wellcome Trust supported this study. The authors declared no relevant conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

A study found significant associations between melasma and several comorbidities, including hypertension and hormonal contraception use, which were the most common.

METHODOLOGY:

• Melasma predominantly affects young women of color and often worsens in hyperestrogen states; understanding the association with comorbidities can improve surveillance and treatment strategies.
• Researchers evaluated 41,283 patients with melasma (mean age, 48.8 years; 93% women) from the TriNetX database and an equal number of matched control individuals.
• The main outcome was comorbidities including allergic rhinitis, atopic dermatitis, anticonvulsants, diabetes, hormonal contraceptives, hypothyroidism, hypertension, lupus, rosacea, skin cancer, and malignancy.

TAKEAWAY:

• Among those with melasma, 25% had hypertension and 24% used hormonal contraception, the two most commonly associated risk factors identified.
• Rosacea (odds ratio [OR], 5.1), atopic dermatitis (OR, 3.3), lupus (OR, 2.5), history of skin cancer (OR, 2.5), and history of internal malignancy (OR, 2.1) were associated with the highest risk of developing melasma (P < .01 for all).
• Asian (OR, 2.0; P < .01) and “other/unknown” races (OR, 1.7; P < .01) and Hispanic ethnicity (OR, 1.3; P < .01) were also significantly associated with melasma, while the odds were slightly lower among White, Black/African American, and “not Hispanic” groups (ORs, 0.8; P < .01 for all groups).

IN PRACTICE:

“Understanding the potential associations between these risk factors and melasma will better improve the management and monitoring of the most susceptible patients,” the authors wrote.

SOURCE:

The study, led by Ajay N. Sharma, MD, MBA, of the Department of Dermatology at the University of California, Irvine, was published online in Journal of Drugs in Dermatology.

LIMITATIONS:

The study limitations included the retrospective design, potential misclassification of diagnoses, and the inability to establish causality.

DISCLOSURES:

The study did not disclose any funding sources. The authors declared no conflicts of interest.

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

TOPLINE:

A study found significant associations between melasma and several comorbidities, including hypertension and hormonal contraception use, which were the most common.

METHODOLOGY:

• Melasma predominantly affects young women of color and often worsens in hyperestrogen states; understanding the association with comorbidities can improve surveillance and treatment strategies.
• Researchers evaluated 41,283 patients with melasma (mean age, 48.8 years; 93% women) from the TriNetX database and an equal number of matched control individuals.
• The main outcome was comorbidities including allergic rhinitis, atopic dermatitis, anticonvulsants, diabetes, hormonal contraceptives, hypothyroidism, hypertension, lupus, rosacea, skin cancer, and malignancy.

TAKEAWAY:

• Among those with melasma, 25% had hypertension and 24% used hormonal contraception, the two most commonly associated risk factors identified.
• Rosacea (odds ratio [OR], 5.1), atopic dermatitis (OR, 3.3), lupus (OR, 2.5), history of skin cancer (OR, 2.5), and history of internal malignancy (OR, 2.1) were associated with the highest risk of developing melasma (P < .01 for all).
• Asian (OR, 2.0; P < .01) and “other/unknown” races (OR, 1.7; P < .01) and Hispanic ethnicity (OR, 1.3; P < .01) were also significantly associated with melasma, while the odds were slightly lower among White, Black/African American, and “not Hispanic” groups (ORs, 0.8; P < .01 for all groups).

IN PRACTICE:

“Understanding the potential associations between these risk factors and melasma will better improve the management and monitoring of the most susceptible patients,” the authors wrote.

SOURCE:

The study, led by Ajay N. Sharma, MD, MBA, of the Department of Dermatology at the University of California, Irvine, was published online in Journal of Drugs in Dermatology.

LIMITATIONS:

The study limitations included the retrospective design, potential misclassification of diagnoses, and the inability to establish causality.

DISCLOSURES:

The study did not disclose any funding sources. The authors declared no conflicts of interest.

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

TOPLINE:

A study found significant associations between melasma and several comorbidities, including hypertension and hormonal contraception use, which were the most common.

METHODOLOGY:

• Melasma predominantly affects young women of color and often worsens in hyperestrogen states; understanding the association with comorbidities can improve surveillance and treatment strategies.
• Researchers evaluated 41,283 patients with melasma (mean age, 48.8 years; 93% women) from the TriNetX database and an equal number of matched control individuals.
• The main outcome was comorbidities including allergic rhinitis, atopic dermatitis, anticonvulsants, diabetes, hormonal contraceptives, hypothyroidism, hypertension, lupus, rosacea, skin cancer, and malignancy.

TAKEAWAY:

• Among those with melasma, 25% had hypertension and 24% used hormonal contraception, the two most commonly associated risk factors identified.
• Rosacea (odds ratio [OR], 5.1), atopic dermatitis (OR, 3.3), lupus (OR, 2.5), history of skin cancer (OR, 2.5), and history of internal malignancy (OR, 2.1) were associated with the highest risk of developing melasma (P < .01 for all).
• Asian (OR, 2.0; P < .01) and “other/unknown” races (OR, 1.7; P < .01) and Hispanic ethnicity (OR, 1.3; P < .01) were also significantly associated with melasma, while the odds were slightly lower among White, Black/African American, and “not Hispanic” groups (ORs, 0.8; P < .01 for all groups).

IN PRACTICE:

“Understanding the potential associations between these risk factors and melasma will better improve the management and monitoring of the most susceptible patients,” the authors wrote.

SOURCE:

The study, led by Ajay N. Sharma, MD, MBA, of the Department of Dermatology at the University of California, Irvine, was published online in Journal of Drugs in Dermatology.

LIMITATIONS:

The study limitations included the retrospective design, potential misclassification of diagnoses, and the inability to establish causality.

DISCLOSURES:

The study did not disclose any funding sources. The authors declared no conflicts of interest.

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.

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 [email protected].

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 [email protected].

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 [email protected].

Strapped for cash and searching for new profits, Tennessee-based Erlanger Health System illegally paid excessive salaries to physicians in exchange for patient referrals, the US government alleged in a federal lawsuit.

Erlanger changed its compensation model to entice revenue-generating doctors, paying some two to three times the median salary for their specialty, according to the complaint. 

The physicians in turn referred numerous patients to Erlanger, and the health system submitted claims to Medicare for the referred services in violation of the Stark Law, according to the suit, filed in US District Court for the Western District of North Carolina. 

The government’s complaint “serves as a warning” to healthcare providers who try to boost profits through improper financial arrangements with referring physicians, said Tamala E. Miles, Special Agent in Charge for the US Department of Health and Human Services (HHS) Office of Inspector General (OIG).

In a statement provided to this news organization, Erlanger denied the allegations and said it would “vigorously” defend the lawsuit. 

“Erlanger paid physicians based on amounts that outside experts advised was fair market value,” Erlanger officials said in the statement. “Erlanger did not pay for referrals. A complete picture of the facts will demonstrate that the allegations lack merit and tell a very different story than what the government now claims.”

The Erlanger case is a reminder to physicians to consult their own knowledgeable advisors when considering financial arrangements with hospitals, said William Sarraille, JD, adjunct professor for the University of Maryland Francis King Carey School of Law in Baltimore and a regulatory consultant. 

“There is a tendency by physicians when contracting ... to rely on [hospitals’] perceived compliance and legal expertise,” Mr. Sarraille told this news organization. “This case illustrates the risks in doing so. Sometimes bigger doesn’t translate into more sophisticated or more effective from a compliance perspective.” 
 

Stark Law Prohibits Kickbacks

The Stark Law prohibits hospitals from billing the Centers for Medicare & Medicaid Services (CMS) for services referred by a physician with whom the hospital has an improper financial relationship.

CMS paid Erlanger about $27.8 million for claims stemming from the improper financial arrangements, the government contends. 

“HHS-OIG will continue to investigate such deals to prevent financial arrangements that could compromise impartial medical judgment, increase healthcare costs, and erode public trust in the healthcare system,” Ms. Miles said in a statement. 
 

Suit: Health System’s Money Woes Led to Illegal Arrangements

Erlanger’s financial troubles allegedly started after a previous run-in with the US government over false claims. 

In 2005, Erlanger Health System agreed to pay the government $40 million to resolve allegations that it knowingly submitted false claims to Medicare, according to the government’s complaint. At the time, Erlanger entered into a Corporate Integrity Agreement (CIA) with the OIG that required Erlanger to put controls in place to ensure its financial relationships did not violate the Stark Law. 

Erlanger’s agreement with OIG ended in 2010. Over the next 3 years, the health system lost nearly $32 million and in fiscal year 2013, had only 65 days of cash on hand, according to the government’s lawsuit. 

Beginning in 2013, Erlanger allegedly implemented a strategy to increase profits by employing more physicians, particularly specialists from competing hospitals whose patients would need costly hospital stays, according to the complaint. 

Once hired, Erlanger’s physicians were expected to treat patients at Erlanger’s hospitals and refer them to other providers within the health system, the suit claims. Erlanger also relaxed or eliminated the oversight and controls on physician compensation put in place under the CIA. For example, Erlanger’s CEO signed some compensation contracts before its chief compliance officer could review them and no longer allowed the compliance officer to vote on whether to approve compensation arrangements, according to the complaint. 

Erlanger also changed its compensation model to include large salaries for medical director and academic positions and allegedly paid such salaries to physicians without ensuring the required work was performed. As a result, Erlanger physicians with profitable referrals were among the highest paid in the nation for their specialties, the government claims. For example, according to the complaint:

• Erlanger paid an electrophysiologist an annual clinical salary of $816,701, a medical director salary of $101,080, an academic salary of $59,322, and a productivity incentive based on work relative value units (wRVUs). The medical director and academic salaries paid were near the 90th percentile of comparable salaries in the specialty.
• The health system paid a neurosurgeon a base salary of $654,735, a productivity incentive based on wRVUs, and payments for excess call coverage ranging from $400 to $1000 per 24-hour shift. In 2016, the neurosurgeon made $500,000 in excess call payments.
• Erlanger paid a cardiothoracic surgeon a base clinical salary of $1,070,000, a sign-on bonus of $150,000, a retention bonus of $100,000 (payable in the 4th year of the contract), and a program incentive of up to $150,000 per year.

In addition, Erlanger ignored patient safety concerns about some of its high revenue-generating physicians, the government claims. 

For instance, Erlanger received multiple complaints that a cardiothoracic surgeon was misusing an expensive form of life support in which pumps and oxygenators take over heart and lung function. Overuse of the equipment prolonged patients’ hospital stays and increased the hospital fees generated by the surgeon, according to the complaint. Staff also raised concerns about the cardiothoracic surgeon’s patient outcomes. 

But Erlanger disregarded the concerns and in 2018, increased the cardiothoracic surgeon’s retention bonus from $100,000 to $250,000, the suit alleges. A year later, the health system increased his base salary from $1,070,000 to $1,195,000.

Health care compensation and billing consultants alerted Erlanger that it was overpaying salaries and handing out bonuses based on measures that overstated the work physicians were performing, but Erlanger ignored the warnings, according to the complaint. 

Administrators allegedly resisted efforts by the chief compliance officer to hire an outside consultant to review its compensation models. Erlanger fired the compliance officer in 2019. 

The former chief compliance officer and another administrator filed a whistleblower lawsuit against Erlanger in 2021. The two administrators are relators in the government’s July 2024 lawsuit. 
 

How to Protect Yourself From Illegal Hospital Deals

The Erlanger case is the latest in a series of recent complaints by the federal government involving financial arrangements between hospitals and physicians.

In December 2023, Indianapolis-based Community Health Network Inc. agreed to pay the government $345 million to resolve claims that it paid physicians above fair market value and awarded bonuses tied to referrals in violation of the Stark Law. 

Also in 2023, Saginaw, Michigan–based Covenant HealthCare and two physicians paid the government $69 million to settle allegations that administrators engaged in improper financial arrangements with referring physicians and a physician-owned investment group. In another 2023 case, Massachusetts Eye and Ear in Boston agreed to pay $5.7 million to resolve claims that some of its physician compensation plans violated the Stark Law. 

Before you enter into a financial arrangement with a hospital, it’s also important to examine what percentile the aggregate compensation would reflect, law professor Mr. Sarraille said. The Erlanger case highlights federal officials’ suspicion of compensation, in aggregate, that exceeds the 90th percentile and increased attention to compensation that exceeds the 75th percentile, he said. 

To research compensation levels, doctors can review the Medical Group Management Association’s annual compensation report or search its compensation data. 

Before signing any contracts, Mr. Sarraille suggests, physicians should also consider whether the hospital shares the same values. Ask physicians at the hospital what they have to say about the hospital’s culture, vision, and values. Have physicians left the hospital after their practices were acquired? Consider speaking with them to learn why. 

Keep in mind that a doctor’s reputation could be impacted by a compliance complaint, regardless of whether it’s directed at the hospital and not the employed physician, Mr. Sarraille said. 

“The [Erlanger] complaint focuses on the compensation of specific, named physicians saying they were wildly overcompensated,” he said. “The implication is that they sold their referral power in exchange for a pay day. It’s a bad look, no matter how the case evolves from here.” 

Physicians could also face their own liability risk under the Stark Law and False Claims Act, depending on the circumstances. In the event of related quality-of-care issues, medical liability could come into play, Mr. Sarraille noted. In such cases, plaintiffs’ attorneys may see an opportunity to boost their claims with allegations that the patient harm was a function of “chasing compensation dollars,” Mr. Sarraille said. 

“Where that happens, plaintiff lawyers see the potential for crippling punitive damages, which might not be covered by an insurer,” he said.

A version of this article appeared on Medscape.com.

Strapped for cash and searching for new profits, Tennessee-based Erlanger Health System illegally paid excessive salaries to physicians in exchange for patient referrals, the US government alleged in a federal lawsuit.

Erlanger changed its compensation model to entice revenue-generating doctors, paying some two to three times the median salary for their specialty, according to the complaint. 

The physicians in turn referred numerous patients to Erlanger, and the health system submitted claims to Medicare for the referred services in violation of the Stark Law, according to the suit, filed in US District Court for the Western District of North Carolina. 

The government’s complaint “serves as a warning” to healthcare providers who try to boost profits through improper financial arrangements with referring physicians, said Tamala E. Miles, Special Agent in Charge for the US Department of Health and Human Services (HHS) Office of Inspector General (OIG).

In a statement provided to this news organization, Erlanger denied the allegations and said it would “vigorously” defend the lawsuit. 

“Erlanger paid physicians based on amounts that outside experts advised was fair market value,” Erlanger officials said in the statement. “Erlanger did not pay for referrals. A complete picture of the facts will demonstrate that the allegations lack merit and tell a very different story than what the government now claims.”

The Erlanger case is a reminder to physicians to consult their own knowledgeable advisors when considering financial arrangements with hospitals, said William Sarraille, JD, adjunct professor for the University of Maryland Francis King Carey School of Law in Baltimore and a regulatory consultant. 

“There is a tendency by physicians when contracting ... to rely on [hospitals’] perceived compliance and legal expertise,” Mr. Sarraille told this news organization. “This case illustrates the risks in doing so. Sometimes bigger doesn’t translate into more sophisticated or more effective from a compliance perspective.” 
 

Stark Law Prohibits Kickbacks

The Stark Law prohibits hospitals from billing the Centers for Medicare & Medicaid Services (CMS) for services referred by a physician with whom the hospital has an improper financial relationship.

CMS paid Erlanger about $27.8 million for claims stemming from the improper financial arrangements, the government contends. 

“HHS-OIG will continue to investigate such deals to prevent financial arrangements that could compromise impartial medical judgment, increase healthcare costs, and erode public trust in the healthcare system,” Ms. Miles said in a statement. 
 

Suit: Health System’s Money Woes Led to Illegal Arrangements

Erlanger’s financial troubles allegedly started after a previous run-in with the US government over false claims. 

In 2005, Erlanger Health System agreed to pay the government $40 million to resolve allegations that it knowingly submitted false claims to Medicare, according to the government’s complaint. At the time, Erlanger entered into a Corporate Integrity Agreement (CIA) with the OIG that required Erlanger to put controls in place to ensure its financial relationships did not violate the Stark Law. 

Erlanger’s agreement with OIG ended in 2010. Over the next 3 years, the health system lost nearly $32 million and in fiscal year 2013, had only 65 days of cash on hand, according to the government’s lawsuit. 

Beginning in 2013, Erlanger allegedly implemented a strategy to increase profits by employing more physicians, particularly specialists from competing hospitals whose patients would need costly hospital stays, according to the complaint. 

Once hired, Erlanger’s physicians were expected to treat patients at Erlanger’s hospitals and refer them to other providers within the health system, the suit claims. Erlanger also relaxed or eliminated the oversight and controls on physician compensation put in place under the CIA. For example, Erlanger’s CEO signed some compensation contracts before its chief compliance officer could review them and no longer allowed the compliance officer to vote on whether to approve compensation arrangements, according to the complaint. 

Erlanger also changed its compensation model to include large salaries for medical director and academic positions and allegedly paid such salaries to physicians without ensuring the required work was performed. As a result, Erlanger physicians with profitable referrals were among the highest paid in the nation for their specialties, the government claims. For example, according to the complaint:

• Erlanger paid an electrophysiologist an annual clinical salary of $816,701, a medical director salary of $101,080, an academic salary of $59,322, and a productivity incentive based on work relative value units (wRVUs). The medical director and academic salaries paid were near the 90th percentile of comparable salaries in the specialty.
• The health system paid a neurosurgeon a base salary of $654,735, a productivity incentive based on wRVUs, and payments for excess call coverage ranging from $400 to $1000 per 24-hour shift. In 2016, the neurosurgeon made $500,000 in excess call payments.
• Erlanger paid a cardiothoracic surgeon a base clinical salary of $1,070,000, a sign-on bonus of $150,000, a retention bonus of $100,000 (payable in the 4th year of the contract), and a program incentive of up to $150,000 per year.

In addition, Erlanger ignored patient safety concerns about some of its high revenue-generating physicians, the government claims. 

For instance, Erlanger received multiple complaints that a cardiothoracic surgeon was misusing an expensive form of life support in which pumps and oxygenators take over heart and lung function. Overuse of the equipment prolonged patients’ hospital stays and increased the hospital fees generated by the surgeon, according to the complaint. Staff also raised concerns about the cardiothoracic surgeon’s patient outcomes. 

But Erlanger disregarded the concerns and in 2018, increased the cardiothoracic surgeon’s retention bonus from $100,000 to $250,000, the suit alleges. A year later, the health system increased his base salary from $1,070,000 to $1,195,000.

Health care compensation and billing consultants alerted Erlanger that it was overpaying salaries and handing out bonuses based on measures that overstated the work physicians were performing, but Erlanger ignored the warnings, according to the complaint. 

Administrators allegedly resisted efforts by the chief compliance officer to hire an outside consultant to review its compensation models. Erlanger fired the compliance officer in 2019. 

The former chief compliance officer and another administrator filed a whistleblower lawsuit against Erlanger in 2021. The two administrators are relators in the government’s July 2024 lawsuit. 
 

How to Protect Yourself From Illegal Hospital Deals

The Erlanger case is the latest in a series of recent complaints by the federal government involving financial arrangements between hospitals and physicians.

In December 2023, Indianapolis-based Community Health Network Inc. agreed to pay the government $345 million to resolve claims that it paid physicians above fair market value and awarded bonuses tied to referrals in violation of the Stark Law. 

Also in 2023, Saginaw, Michigan–based Covenant HealthCare and two physicians paid the government $69 million to settle allegations that administrators engaged in improper financial arrangements with referring physicians and a physician-owned investment group. In another 2023 case, Massachusetts Eye and Ear in Boston agreed to pay $5.7 million to resolve claims that some of its physician compensation plans violated the Stark Law. 

Before you enter into a financial arrangement with a hospital, it’s also important to examine what percentile the aggregate compensation would reflect, law professor Mr. Sarraille said. The Erlanger case highlights federal officials’ suspicion of compensation, in aggregate, that exceeds the 90th percentile and increased attention to compensation that exceeds the 75th percentile, he said. 

To research compensation levels, doctors can review the Medical Group Management Association’s annual compensation report or search its compensation data. 

Before signing any contracts, Mr. Sarraille suggests, physicians should also consider whether the hospital shares the same values. Ask physicians at the hospital what they have to say about the hospital’s culture, vision, and values. Have physicians left the hospital after their practices were acquired? Consider speaking with them to learn why. 

Keep in mind that a doctor’s reputation could be impacted by a compliance complaint, regardless of whether it’s directed at the hospital and not the employed physician, Mr. Sarraille said. 

“The [Erlanger] complaint focuses on the compensation of specific, named physicians saying they were wildly overcompensated,” he said. “The implication is that they sold their referral power in exchange for a pay day. It’s a bad look, no matter how the case evolves from here.” 

Physicians could also face their own liability risk under the Stark Law and False Claims Act, depending on the circumstances. In the event of related quality-of-care issues, medical liability could come into play, Mr. Sarraille noted. In such cases, plaintiffs’ attorneys may see an opportunity to boost their claims with allegations that the patient harm was a function of “chasing compensation dollars,” Mr. Sarraille said. 

“Where that happens, plaintiff lawyers see the potential for crippling punitive damages, which might not be covered by an insurer,” he said.

A version of this article appeared on Medscape.com.

Strapped for cash and searching for new profits, Tennessee-based Erlanger Health System illegally paid excessive salaries to physicians in exchange for patient referrals, the US government alleged in a federal lawsuit.

Erlanger changed its compensation model to entice revenue-generating doctors, paying some two to three times the median salary for their specialty, according to the complaint. 

The physicians in turn referred numerous patients to Erlanger, and the health system submitted claims to Medicare for the referred services in violation of the Stark Law, according to the suit, filed in US District Court for the Western District of North Carolina. 

The government’s complaint “serves as a warning” to healthcare providers who try to boost profits through improper financial arrangements with referring physicians, said Tamala E. Miles, Special Agent in Charge for the US Department of Health and Human Services (HHS) Office of Inspector General (OIG).

In a statement provided to this news organization, Erlanger denied the allegations and said it would “vigorously” defend the lawsuit. 

“Erlanger paid physicians based on amounts that outside experts advised was fair market value,” Erlanger officials said in the statement. “Erlanger did not pay for referrals. A complete picture of the facts will demonstrate that the allegations lack merit and tell a very different story than what the government now claims.”

The Erlanger case is a reminder to physicians to consult their own knowledgeable advisors when considering financial arrangements with hospitals, said William Sarraille, JD, adjunct professor for the University of Maryland Francis King Carey School of Law in Baltimore and a regulatory consultant. 

“There is a tendency by physicians when contracting ... to rely on [hospitals’] perceived compliance and legal expertise,” Mr. Sarraille told this news organization. “This case illustrates the risks in doing so. Sometimes bigger doesn’t translate into more sophisticated or more effective from a compliance perspective.” 
 

Stark Law Prohibits Kickbacks

The Stark Law prohibits hospitals from billing the Centers for Medicare & Medicaid Services (CMS) for services referred by a physician with whom the hospital has an improper financial relationship.

CMS paid Erlanger about $27.8 million for claims stemming from the improper financial arrangements, the government contends. 

“HHS-OIG will continue to investigate such deals to prevent financial arrangements that could compromise impartial medical judgment, increase healthcare costs, and erode public trust in the healthcare system,” Ms. Miles said in a statement. 
 

Suit: Health System’s Money Woes Led to Illegal Arrangements

Erlanger’s financial troubles allegedly started after a previous run-in with the US government over false claims. 

In 2005, Erlanger Health System agreed to pay the government $40 million to resolve allegations that it knowingly submitted false claims to Medicare, according to the government’s complaint. At the time, Erlanger entered into a Corporate Integrity Agreement (CIA) with the OIG that required Erlanger to put controls in place to ensure its financial relationships did not violate the Stark Law. 

Erlanger’s agreement with OIG ended in 2010. Over the next 3 years, the health system lost nearly $32 million and in fiscal year 2013, had only 65 days of cash on hand, according to the government’s lawsuit. 

Beginning in 2013, Erlanger allegedly implemented a strategy to increase profits by employing more physicians, particularly specialists from competing hospitals whose patients would need costly hospital stays, according to the complaint. 

Once hired, Erlanger’s physicians were expected to treat patients at Erlanger’s hospitals and refer them to other providers within the health system, the suit claims. Erlanger also relaxed or eliminated the oversight and controls on physician compensation put in place under the CIA. For example, Erlanger’s CEO signed some compensation contracts before its chief compliance officer could review them and no longer allowed the compliance officer to vote on whether to approve compensation arrangements, according to the complaint. 

Erlanger also changed its compensation model to include large salaries for medical director and academic positions and allegedly paid such salaries to physicians without ensuring the required work was performed. As a result, Erlanger physicians with profitable referrals were among the highest paid in the nation for their specialties, the government claims. For example, according to the complaint:

• Erlanger paid an electrophysiologist an annual clinical salary of $816,701, a medical director salary of $101,080, an academic salary of $59,322, and a productivity incentive based on work relative value units (wRVUs). The medical director and academic salaries paid were near the 90th percentile of comparable salaries in the specialty.
• The health system paid a neurosurgeon a base salary of $654,735, a productivity incentive based on wRVUs, and payments for excess call coverage ranging from $400 to $1000 per 24-hour shift. In 2016, the neurosurgeon made $500,000 in excess call payments.
• Erlanger paid a cardiothoracic surgeon a base clinical salary of $1,070,000, a sign-on bonus of $150,000, a retention bonus of $100,000 (payable in the 4th year of the contract), and a program incentive of up to $150,000 per year.

In addition, Erlanger ignored patient safety concerns about some of its high revenue-generating physicians, the government claims. 

For instance, Erlanger received multiple complaints that a cardiothoracic surgeon was misusing an expensive form of life support in which pumps and oxygenators take over heart and lung function. Overuse of the equipment prolonged patients’ hospital stays and increased the hospital fees generated by the surgeon, according to the complaint. Staff also raised concerns about the cardiothoracic surgeon’s patient outcomes. 

But Erlanger disregarded the concerns and in 2018, increased the cardiothoracic surgeon’s retention bonus from $100,000 to $250,000, the suit alleges. A year later, the health system increased his base salary from $1,070,000 to $1,195,000.

Health care compensation and billing consultants alerted Erlanger that it was overpaying salaries and handing out bonuses based on measures that overstated the work physicians were performing, but Erlanger ignored the warnings, according to the complaint. 

Administrators allegedly resisted efforts by the chief compliance officer to hire an outside consultant to review its compensation models. Erlanger fired the compliance officer in 2019. 

The former chief compliance officer and another administrator filed a whistleblower lawsuit against Erlanger in 2021. The two administrators are relators in the government’s July 2024 lawsuit. 
 

How to Protect Yourself From Illegal Hospital Deals

The Erlanger case is the latest in a series of recent complaints by the federal government involving financial arrangements between hospitals and physicians.

In December 2023, Indianapolis-based Community Health Network Inc. agreed to pay the government $345 million to resolve claims that it paid physicians above fair market value and awarded bonuses tied to referrals in violation of the Stark Law. 

Also in 2023, Saginaw, Michigan–based Covenant HealthCare and two physicians paid the government $69 million to settle allegations that administrators engaged in improper financial arrangements with referring physicians and a physician-owned investment group. In another 2023 case, Massachusetts Eye and Ear in Boston agreed to pay $5.7 million to resolve claims that some of its physician compensation plans violated the Stark Law. 

Before you enter into a financial arrangement with a hospital, it’s also important to examine what percentile the aggregate compensation would reflect, law professor Mr. Sarraille said. The Erlanger case highlights federal officials’ suspicion of compensation, in aggregate, that exceeds the 90th percentile and increased attention to compensation that exceeds the 75th percentile, he said. 

To research compensation levels, doctors can review the Medical Group Management Association’s annual compensation report or search its compensation data. 

Before signing any contracts, Mr. Sarraille suggests, physicians should also consider whether the hospital shares the same values. Ask physicians at the hospital what they have to say about the hospital’s culture, vision, and values. Have physicians left the hospital after their practices were acquired? Consider speaking with them to learn why. 

Keep in mind that a doctor’s reputation could be impacted by a compliance complaint, regardless of whether it’s directed at the hospital and not the employed physician, Mr. Sarraille said. 

“The [Erlanger] complaint focuses on the compensation of specific, named physicians saying they were wildly overcompensated,” he said. “The implication is that they sold their referral power in exchange for a pay day. It’s a bad look, no matter how the case evolves from here.” 

Physicians could also face their own liability risk under the Stark Law and False Claims Act, depending on the circumstances. In the event of related quality-of-care issues, medical liability could come into play, Mr. Sarraille noted. In such cases, plaintiffs’ attorneys may see an opportunity to boost their claims with allegations that the patient harm was a function of “chasing compensation dollars,” Mr. Sarraille said. 

“Where that happens, plaintiff lawyers see the potential for crippling punitive damages, which might not be covered by an insurer,” he said.

A version of this article appeared on Medscape.com.

In a case that spotlights the importance of comprehensive financial controls in medical offices, a leading New York City emergency medicine physician stands accused of using his business credit card to steal nearly $1.5 million from his clinical practice and spend it on cash advances, personal travel, lavish pet services, and more.

Michael Lucchesi, MD, who had served as chairman of Emergency Medicine at SUNY Downstate Medical Center in New York City, was arraigned on July 9 and pleaded not guilty. Dr. Lucchesi’s attorney, Earl Ward, did not respond to messages from this news organization, but he told the New York Post that “the funds he used were not stolen funds.”

Dr. Lucchesi, who’s in his late 60s, faces nine counts of first- and second-degree grand larceny, first-degree falsifying business records, and third-degree criminal tax fraud. According to a press statement from the district attorney of Kings County, which encompasses the borough of Brooklyn, Dr. Lucchesi is accused of using his clinical practice’s business card for cash advances (about $115,000), high-end pet care ($176,000), personal travel ($348,000), gym membership and personal training ($109,000), catering ($52,000), tuition payments for his children ($46,000), and other expenses such as online shopping, flowers, liquor, and electronics.

Most of the alleged pet care spending — $120,000 — went to the Green Leaf Pet Resort, which has two locations in New Jersey, including one with “56 acres of nature and lots of tail wagging.” Some of the alleged spending on gym membership was at the New York Sports Clubs chain, where monthly membership tops out at $139.99.

The alleged spending occurred between 2016 and 2023 and was discovered by SUNY Downstate during an audit. Dr. Lucchesi reportedly left his position at the hospital, where he made $399,712 in 2022 as a professor, according to public records.

“As a high-ranking doctor at this vital healthcare institution, this defendant was entrusted with access to significant funds, which he allegedly exploited, stealing more than 1 million dollars to pay for a lavish lifestyle,” District Attorney Eric Gonzalez said in a statement.

SUNY Downstate is in a fight for its life amid efforts by New York Governor Kathy Hochul to shut it down. According to The New York Times, it is the only state-run hospital in New York City.

Dr. Lucchesi, who had previously served as the hospital’s chief medical officer and acting head, was released without bail. His next court date is September 25, 2024.
 

Size of Alleged Theft Is ‘Very Unusual’

David P. Weber, JD, DBA, a professor and fraud specialist at Salisbury University, Salisbury, Maryland, told this news organization that the fraudulent use of a business or purchase credit card is a form of embezzlement and “one of the most frequently seen types of frauds against organizations.”

William J. Kresse, JD, MSA, CPA/CFF, who studies fraud at Governors State University in University Park, Illinois, noted in an interview with this news organization that the high amount of alleged fraud in this case is “very unusual,” as is the period it is said to have occurred (over 6 years).

Mr. Kresse highlighted a 2024 report by the Association of Certified Fraud Examiners, which found that the median fraud loss in healthcare, on the basis of 117 cases, is $100,000. The most common form of fraud in the industry is corruption (47%), followed by billing (38%), noncash theft such as inventory (22%), and expense reimbursement (21%).

The details of the current case suggest that “SUNY Downstate had weak or insufficient internal controls to prevent this type of fraud,” Salisbury University’s Mr. Weber said. “However, research also makes clear that the tenure and position of the perpetrator play a significant role in the size of the fraud. Internal controls are supposed to apply to all employees, but the higher in the organization the perpetrator is, the easier it can be to engage in fraud.”
 

Even Small Medical Offices Can Act to Prevent Fraud

What can be done to prevent this kind of fraud? “Each employee should be required to submit actual receipts or scanned copies, and the reimbursement requests should be reviewed and inputted by a separate department or office of the organization to ensure that the expenses are legitimate,” Mr. Weber said. “In addition, all credit card statements should be available for review by the organization either simultaneously with the bill going to the employee or available for audit or review at any time without notification to the employee. Expenses that are in certain categories should be prohibited automatically and coded to the card so such a charge is rejected by the credit card bank.”

Smaller businesses — like many medical practices — may not have the manpower to handle these roles. In that case, Mr. Weber said, “The key is segregation or separation of duties. The bookkeeper cannot be the person receiving the bank statements, the payments from patients, and the invoices from vendors. There needs to be at least one other person in the loop to have some level of control.”

One strategy, he said, “is that the practice should institute a policy that only the doctor or owner of the practice can receive the mail, not the bookkeeper. Even if the practice leader does not actually review the bank statements, simply opening them before handing them off to the bookkeeper can provide a level of deterrence [since] the employee may get caught if someone else is reviewing the bank statements.”
 

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

In a case that spotlights the importance of comprehensive financial controls in medical offices, a leading New York City emergency medicine physician stands accused of using his business credit card to steal nearly $1.5 million from his clinical practice and spend it on cash advances, personal travel, lavish pet services, and more.

Michael Lucchesi, MD, who had served as chairman of Emergency Medicine at SUNY Downstate Medical Center in New York City, was arraigned on July 9 and pleaded not guilty. Dr. Lucchesi’s attorney, Earl Ward, did not respond to messages from this news organization, but he told the New York Post that “the funds he used were not stolen funds.”

Dr. Lucchesi, who’s in his late 60s, faces nine counts of first- and second-degree grand larceny, first-degree falsifying business records, and third-degree criminal tax fraud. According to a press statement from the district attorney of Kings County, which encompasses the borough of Brooklyn, Dr. Lucchesi is accused of using his clinical practice’s business card for cash advances (about $115,000), high-end pet care ($176,000), personal travel ($348,000), gym membership and personal training ($109,000), catering ($52,000), tuition payments for his children ($46,000), and other expenses such as online shopping, flowers, liquor, and electronics.

Most of the alleged pet care spending — $120,000 — went to the Green Leaf Pet Resort, which has two locations in New Jersey, including one with “56 acres of nature and lots of tail wagging.” Some of the alleged spending on gym membership was at the New York Sports Clubs chain, where monthly membership tops out at $139.99.

The alleged spending occurred between 2016 and 2023 and was discovered by SUNY Downstate during an audit. Dr. Lucchesi reportedly left his position at the hospital, where he made $399,712 in 2022 as a professor, according to public records.

“As a high-ranking doctor at this vital healthcare institution, this defendant was entrusted with access to significant funds, which he allegedly exploited, stealing more than 1 million dollars to pay for a lavish lifestyle,” District Attorney Eric Gonzalez said in a statement.

SUNY Downstate is in a fight for its life amid efforts by New York Governor Kathy Hochul to shut it down. According to The New York Times, it is the only state-run hospital in New York City.

Dr. Lucchesi, who had previously served as the hospital’s chief medical officer and acting head, was released without bail. His next court date is September 25, 2024.
 

Size of Alleged Theft Is ‘Very Unusual’

David P. Weber, JD, DBA, a professor and fraud specialist at Salisbury University, Salisbury, Maryland, told this news organization that the fraudulent use of a business or purchase credit card is a form of embezzlement and “one of the most frequently seen types of frauds against organizations.”

William J. Kresse, JD, MSA, CPA/CFF, who studies fraud at Governors State University in University Park, Illinois, noted in an interview with this news organization that the high amount of alleged fraud in this case is “very unusual,” as is the period it is said to have occurred (over 6 years).

Mr. Kresse highlighted a 2024 report by the Association of Certified Fraud Examiners, which found that the median fraud loss in healthcare, on the basis of 117 cases, is $100,000. The most common form of fraud in the industry is corruption (47%), followed by billing (38%), noncash theft such as inventory (22%), and expense reimbursement (21%).

The details of the current case suggest that “SUNY Downstate had weak or insufficient internal controls to prevent this type of fraud,” Salisbury University’s Mr. Weber said. “However, research also makes clear that the tenure and position of the perpetrator play a significant role in the size of the fraud. Internal controls are supposed to apply to all employees, but the higher in the organization the perpetrator is, the easier it can be to engage in fraud.”
 

Even Small Medical Offices Can Act to Prevent Fraud

What can be done to prevent this kind of fraud? “Each employee should be required to submit actual receipts or scanned copies, and the reimbursement requests should be reviewed and inputted by a separate department or office of the organization to ensure that the expenses are legitimate,” Mr. Weber said. “In addition, all credit card statements should be available for review by the organization either simultaneously with the bill going to the employee or available for audit or review at any time without notification to the employee. Expenses that are in certain categories should be prohibited automatically and coded to the card so such a charge is rejected by the credit card bank.”

Smaller businesses — like many medical practices — may not have the manpower to handle these roles. In that case, Mr. Weber said, “The key is segregation or separation of duties. The bookkeeper cannot be the person receiving the bank statements, the payments from patients, and the invoices from vendors. There needs to be at least one other person in the loop to have some level of control.”

One strategy, he said, “is that the practice should institute a policy that only the doctor or owner of the practice can receive the mail, not the bookkeeper. Even if the practice leader does not actually review the bank statements, simply opening them before handing them off to the bookkeeper can provide a level of deterrence [since] the employee may get caught if someone else is reviewing the bank statements.”
 

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

In a case that spotlights the importance of comprehensive financial controls in medical offices, a leading New York City emergency medicine physician stands accused of using his business credit card to steal nearly $1.5 million from his clinical practice and spend it on cash advances, personal travel, lavish pet services, and more.

Michael Lucchesi, MD, who had served as chairman of Emergency Medicine at SUNY Downstate Medical Center in New York City, was arraigned on July 9 and pleaded not guilty. Dr. Lucchesi’s attorney, Earl Ward, did not respond to messages from this news organization, but he told the New York Post that “the funds he used were not stolen funds.”

Dr. Lucchesi, who’s in his late 60s, faces nine counts of first- and second-degree grand larceny, first-degree falsifying business records, and third-degree criminal tax fraud. According to a press statement from the district attorney of Kings County, which encompasses the borough of Brooklyn, Dr. Lucchesi is accused of using his clinical practice’s business card for cash advances (about $115,000), high-end pet care ($176,000), personal travel ($348,000), gym membership and personal training ($109,000), catering ($52,000), tuition payments for his children ($46,000), and other expenses such as online shopping, flowers, liquor, and electronics.

Most of the alleged pet care spending — $120,000 — went to the Green Leaf Pet Resort, which has two locations in New Jersey, including one with “56 acres of nature and lots of tail wagging.” Some of the alleged spending on gym membership was at the New York Sports Clubs chain, where monthly membership tops out at $139.99.

The alleged spending occurred between 2016 and 2023 and was discovered by SUNY Downstate during an audit. Dr. Lucchesi reportedly left his position at the hospital, where he made $399,712 in 2022 as a professor, according to public records.

“As a high-ranking doctor at this vital healthcare institution, this defendant was entrusted with access to significant funds, which he allegedly exploited, stealing more than 1 million dollars to pay for a lavish lifestyle,” District Attorney Eric Gonzalez said in a statement.

SUNY Downstate is in a fight for its life amid efforts by New York Governor Kathy Hochul to shut it down. According to The New York Times, it is the only state-run hospital in New York City.

Dr. Lucchesi, who had previously served as the hospital’s chief medical officer and acting head, was released without bail. His next court date is September 25, 2024.
 

Size of Alleged Theft Is ‘Very Unusual’

David P. Weber, JD, DBA, a professor and fraud specialist at Salisbury University, Salisbury, Maryland, told this news organization that the fraudulent use of a business or purchase credit card is a form of embezzlement and “one of the most frequently seen types of frauds against organizations.”

William J. Kresse, JD, MSA, CPA/CFF, who studies fraud at Governors State University in University Park, Illinois, noted in an interview with this news organization that the high amount of alleged fraud in this case is “very unusual,” as is the period it is said to have occurred (over 6 years).

Mr. Kresse highlighted a 2024 report by the Association of Certified Fraud Examiners, which found that the median fraud loss in healthcare, on the basis of 117 cases, is $100,000. The most common form of fraud in the industry is corruption (47%), followed by billing (38%), noncash theft such as inventory (22%), and expense reimbursement (21%).

The details of the current case suggest that “SUNY Downstate had weak or insufficient internal controls to prevent this type of fraud,” Salisbury University’s Mr. Weber said. “However, research also makes clear that the tenure and position of the perpetrator play a significant role in the size of the fraud. Internal controls are supposed to apply to all employees, but the higher in the organization the perpetrator is, the easier it can be to engage in fraud.”
 

Even Small Medical Offices Can Act to Prevent Fraud

What can be done to prevent this kind of fraud? “Each employee should be required to submit actual receipts or scanned copies, and the reimbursement requests should be reviewed and inputted by a separate department or office of the organization to ensure that the expenses are legitimate,” Mr. Weber said. “In addition, all credit card statements should be available for review by the organization either simultaneously with the bill going to the employee or available for audit or review at any time without notification to the employee. Expenses that are in certain categories should be prohibited automatically and coded to the card so such a charge is rejected by the credit card bank.”

Smaller businesses — like many medical practices — may not have the manpower to handle these roles. In that case, Mr. Weber said, “The key is segregation or separation of duties. The bookkeeper cannot be the person receiving the bank statements, the payments from patients, and the invoices from vendors. There needs to be at least one other person in the loop to have some level of control.”

One strategy, he said, “is that the practice should institute a policy that only the doctor or owner of the practice can receive the mail, not the bookkeeper. Even if the practice leader does not actually review the bank statements, simply opening them before handing them off to the bookkeeper can provide a level of deterrence [since] the employee may get caught if someone else is reviewing the bank statements.”
 

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

The US Food and Drug Administration (FDA) has approved afamitresgene autoleucel (afami-cel) (Tecelra, Adaptimmune LLC) to treat advanced synovial sarcoma. 

Afami-cel — the first engineered cell therapy for a solid tumor — is indicated specifically for adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are positive for several human leukocyte antigens (HLAs), and whose tumors express melanoma-associated antigen A4, as determined by FDA-authorized companion diagnostic devices.

The single-dose treatment targets solid tumors expressing melanoma-associated antigen A4, a protein highly expressed in synovial sarcoma.

Synovial sarcoma is a rare form of cancer, which affects about 1000 people in the US each year. Malignant cells develop and form a tumor in soft tissues, often in the extremities. 

“Adults with metastatic synovial sarcoma, a life-threatening form of cancer, often face limited treatment options in addition to the risk of cancer spread or recurrence,” Nicole Verdun, MD, director of the Office of Therapeutic Products in the FDA’s Center for Biologics Evaluation and Research, said in the agency press release announcing the approval. “Today’s approval represents a significant milestone in the development of an innovative, safe and effective therapy for patients with this rare but potentially fatal disease.”

T-cell receptor therapy, like chimeric antigen receptor (CAR) T-cell (CAR-T) therapy, involves altering patient T cells to fight cancer. While CAR-T therapy inserts an artificial receptor to target a specific surface protein on cancer cells, the T-cell receptor therapy modifies existing receptors to recognize an array of antigens on the surface of cancer cells — a promising strategy for targeting solid tumors. 

The accelerated approval of afami-cel was based on the phase 2 SPEARHEAD-1 trial in 44 patients with synovial sarcoma who received a single infusion of the therapy. The trial had enrolled 52 patients, but 8 did not receive afami-cel, including 3 who died and 1 who withdrew. 

According to the FDA announcement, the overall response rate was 43.2%, with a median time to response of 4.9 weeks. The median duration of response was 6 months (95% CI, 4.6 months to not reached). Among patients who responded, 39% had a duration of response of 12 months or longer.

“These results suggest that a one-time treatment with afami-cel has the potential to extend life while allowing responders to go off chemotherapy,” said lead investigator Sandra D’Angelo, MD, a sarcoma specialist at Memorial Sloan Kettering Cancer Center in New York City, in a company press release.

The prescribing information includes a boxed warning for serious or fatal cytokine release syndrome.

The most common nonlaboratory adverse reactions, occurring in at least 20% of patients, included cytokine release syndrome, nausea, vomiting, fatigue, infections, pyrexia, constipation, dyspnea, tachycardia, hypotension, diarrhea, and edema. The most common grade 3 or 4 laboratory abnormalities, occurring in at least 20% of patients, included decreased lymphocyte count, neutrophil count, white cell blood count, red blood cell, and platelet count.

The recommended dose is between 2.68x109 to 10x109 MAGE-A4 T-cell receptor–positive T-cells. The FDA notice specifies not using a leukodepleting filter or prophylactic systemic corticosteroids.

The list price for the one-time therapy is $727,000, according to Fierce Pharma.
 

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

The US Food and Drug Administration (FDA) has approved afamitresgene autoleucel (afami-cel) (Tecelra, Adaptimmune LLC) to treat advanced synovial sarcoma. 

Afami-cel — the first engineered cell therapy for a solid tumor — is indicated specifically for adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are positive for several human leukocyte antigens (HLAs), and whose tumors express melanoma-associated antigen A4, as determined by FDA-authorized companion diagnostic devices.

The single-dose treatment targets solid tumors expressing melanoma-associated antigen A4, a protein highly expressed in synovial sarcoma.

Synovial sarcoma is a rare form of cancer, which affects about 1000 people in the US each year. Malignant cells develop and form a tumor in soft tissues, often in the extremities. 

“Adults with metastatic synovial sarcoma, a life-threatening form of cancer, often face limited treatment options in addition to the risk of cancer spread or recurrence,” Nicole Verdun, MD, director of the Office of Therapeutic Products in the FDA’s Center for Biologics Evaluation and Research, said in the agency press release announcing the approval. “Today’s approval represents a significant milestone in the development of an innovative, safe and effective therapy for patients with this rare but potentially fatal disease.”

T-cell receptor therapy, like chimeric antigen receptor (CAR) T-cell (CAR-T) therapy, involves altering patient T cells to fight cancer. While CAR-T therapy inserts an artificial receptor to target a specific surface protein on cancer cells, the T-cell receptor therapy modifies existing receptors to recognize an array of antigens on the surface of cancer cells — a promising strategy for targeting solid tumors. 

The accelerated approval of afami-cel was based on the phase 2 SPEARHEAD-1 trial in 44 patients with synovial sarcoma who received a single infusion of the therapy. The trial had enrolled 52 patients, but 8 did not receive afami-cel, including 3 who died and 1 who withdrew. 

According to the FDA announcement, the overall response rate was 43.2%, with a median time to response of 4.9 weeks. The median duration of response was 6 months (95% CI, 4.6 months to not reached). Among patients who responded, 39% had a duration of response of 12 months or longer.

“These results suggest that a one-time treatment with afami-cel has the potential to extend life while allowing responders to go off chemotherapy,” said lead investigator Sandra D’Angelo, MD, a sarcoma specialist at Memorial Sloan Kettering Cancer Center in New York City, in a company press release.

The prescribing information includes a boxed warning for serious or fatal cytokine release syndrome.

The most common nonlaboratory adverse reactions, occurring in at least 20% of patients, included cytokine release syndrome, nausea, vomiting, fatigue, infections, pyrexia, constipation, dyspnea, tachycardia, hypotension, diarrhea, and edema. The most common grade 3 or 4 laboratory abnormalities, occurring in at least 20% of patients, included decreased lymphocyte count, neutrophil count, white cell blood count, red blood cell, and platelet count.

The recommended dose is between 2.68x109 to 10x109 MAGE-A4 T-cell receptor–positive T-cells. The FDA notice specifies not using a leukodepleting filter or prophylactic systemic corticosteroids.

The list price for the one-time therapy is $727,000, according to Fierce Pharma.
 

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

The US Food and Drug Administration (FDA) has approved afamitresgene autoleucel (afami-cel) (Tecelra, Adaptimmune LLC) to treat advanced synovial sarcoma. 

Afami-cel — the first engineered cell therapy for a solid tumor — is indicated specifically for adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are positive for several human leukocyte antigens (HLAs), and whose tumors express melanoma-associated antigen A4, as determined by FDA-authorized companion diagnostic devices.

The single-dose treatment targets solid tumors expressing melanoma-associated antigen A4, a protein highly expressed in synovial sarcoma.

Synovial sarcoma is a rare form of cancer, which affects about 1000 people in the US each year. Malignant cells develop and form a tumor in soft tissues, often in the extremities. 

“Adults with metastatic synovial sarcoma, a life-threatening form of cancer, often face limited treatment options in addition to the risk of cancer spread or recurrence,” Nicole Verdun, MD, director of the Office of Therapeutic Products in the FDA’s Center for Biologics Evaluation and Research, said in the agency press release announcing the approval. “Today’s approval represents a significant milestone in the development of an innovative, safe and effective therapy for patients with this rare but potentially fatal disease.”

T-cell receptor therapy, like chimeric antigen receptor (CAR) T-cell (CAR-T) therapy, involves altering patient T cells to fight cancer. While CAR-T therapy inserts an artificial receptor to target a specific surface protein on cancer cells, the T-cell receptor therapy modifies existing receptors to recognize an array of antigens on the surface of cancer cells — a promising strategy for targeting solid tumors. 

The accelerated approval of afami-cel was based on the phase 2 SPEARHEAD-1 trial in 44 patients with synovial sarcoma who received a single infusion of the therapy. The trial had enrolled 52 patients, but 8 did not receive afami-cel, including 3 who died and 1 who withdrew. 

According to the FDA announcement, the overall response rate was 43.2%, with a median time to response of 4.9 weeks. The median duration of response was 6 months (95% CI, 4.6 months to not reached). Among patients who responded, 39% had a duration of response of 12 months or longer.

“These results suggest that a one-time treatment with afami-cel has the potential to extend life while allowing responders to go off chemotherapy,” said lead investigator Sandra D’Angelo, MD, a sarcoma specialist at Memorial Sloan Kettering Cancer Center in New York City, in a company press release.

The prescribing information includes a boxed warning for serious or fatal cytokine release syndrome.

The most common nonlaboratory adverse reactions, occurring in at least 20% of patients, included cytokine release syndrome, nausea, vomiting, fatigue, infections, pyrexia, constipation, dyspnea, tachycardia, hypotension, diarrhea, and edema. The most common grade 3 or 4 laboratory abnormalities, occurring in at least 20% of patients, included decreased lymphocyte count, neutrophil count, white cell blood count, red blood cell, and platelet count.

The recommended dose is between 2.68x109 to 10x109 MAGE-A4 T-cell receptor–positive T-cells. The FDA notice specifies not using a leukodepleting filter or prophylactic systemic corticosteroids.

The list price for the one-time therapy is $727,000, according to Fierce Pharma.
 

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

The US Food and Drug Administration (FDA) has expanded the approval of dostarlimab-gxly (Jemperli, GSK) in conjunction with carboplatin and paclitaxel, followed by single-agent dostarlimab-gxly, for adults with primary advanced or recurrent endometrial cancer.

Prior FDA approval of the combination was granted for adults with primary advanced or recurrent endometrial cancer that was mismatch repair deficient (dMMR) or microsatellite instability–high (MSI-H).

The expanded approval, granted following a priority review, was based on efficacy and safety demonstrated in the randomized, controlled, multicenter RUBY trial, which included 494 patients who were randomized to receive the dostarlimab-gxly regimen or placebo plus carboplatin and paclitaxel, followed by placebo.

Researchers observed a significant improvement in median overall survival with treatment vs placebo in the overall population — 44.6 vs 28.2 months, respectively (hazard ratio [HR], 0.69). Median progression-free survival was also significantly better in the treatment vs placebo group — 11.8 vs 7.9 months, respectively (HR, 0.64).

“Today’s expanded approval will offer even more patients the opportunity for improved outcomes,” Matthew Powell, MD, of Washington University School of Medicine, and principal investigator on the RUBY trial, said in a press release. “This is the only immuno-oncology treatment regimen that has shown a statistically significant overall survival benefit for the full patient population, which is a meaningful step forward in treating this challenging cancer.”

Adverse reactions occurring in at least 20% of patients receiving dostarlimab-gxly include anemia, increased creatinine levels, peripheral neuropathy, decreased white blood cell counts, fatigue, nausea, alopecia, low platelet counts, increased glucose levels, lymphopenia, neutropenia, liver function test abnormalities, arthralgia, rash, constipation, diarrhea, decreased albumin levels, abdominal pain, dyspnea, decreased appetite, increased amylase levels, urinary tract infection, and vomiting. Immune-mediated adverse reactions with dostarlimab-gxly were similar to those previously reported.

The recommended dostarlimab-gxly dose, according to the full prescribing information, is 500 mg every 3 weeks for six cycles administered before carboplatin and paclitaxel if given on the same day, followed by 1000 mg monotherapy every 6 weeks until disease progression or unacceptable toxicity, or up to 3 years.
 

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

The US Food and Drug Administration (FDA) has expanded the approval of dostarlimab-gxly (Jemperli, GSK) in conjunction with carboplatin and paclitaxel, followed by single-agent dostarlimab-gxly, for adults with primary advanced or recurrent endometrial cancer.

Prior FDA approval of the combination was granted for adults with primary advanced or recurrent endometrial cancer that was mismatch repair deficient (dMMR) or microsatellite instability–high (MSI-H).

The expanded approval, granted following a priority review, was based on efficacy and safety demonstrated in the randomized, controlled, multicenter RUBY trial, which included 494 patients who were randomized to receive the dostarlimab-gxly regimen or placebo plus carboplatin and paclitaxel, followed by placebo.

Researchers observed a significant improvement in median overall survival with treatment vs placebo in the overall population — 44.6 vs 28.2 months, respectively (hazard ratio [HR], 0.69). Median progression-free survival was also significantly better in the treatment vs placebo group — 11.8 vs 7.9 months, respectively (HR, 0.64).

“Today’s expanded approval will offer even more patients the opportunity for improved outcomes,” Matthew Powell, MD, of Washington University School of Medicine, and principal investigator on the RUBY trial, said in a press release. “This is the only immuno-oncology treatment regimen that has shown a statistically significant overall survival benefit for the full patient population, which is a meaningful step forward in treating this challenging cancer.”

Adverse reactions occurring in at least 20% of patients receiving dostarlimab-gxly include anemia, increased creatinine levels, peripheral neuropathy, decreased white blood cell counts, fatigue, nausea, alopecia, low platelet counts, increased glucose levels, lymphopenia, neutropenia, liver function test abnormalities, arthralgia, rash, constipation, diarrhea, decreased albumin levels, abdominal pain, dyspnea, decreased appetite, increased amylase levels, urinary tract infection, and vomiting. Immune-mediated adverse reactions with dostarlimab-gxly were similar to those previously reported.

The recommended dostarlimab-gxly dose, according to the full prescribing information, is 500 mg every 3 weeks for six cycles administered before carboplatin and paclitaxel if given on the same day, followed by 1000 mg monotherapy every 6 weeks until disease progression or unacceptable toxicity, or up to 3 years.
 

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

The US Food and Drug Administration (FDA) has expanded the approval of dostarlimab-gxly (Jemperli, GSK) in conjunction with carboplatin and paclitaxel, followed by single-agent dostarlimab-gxly, for adults with primary advanced or recurrent endometrial cancer.

Prior FDA approval of the combination was granted for adults with primary advanced or recurrent endometrial cancer that was mismatch repair deficient (dMMR) or microsatellite instability–high (MSI-H).

The expanded approval, granted following a priority review, was based on efficacy and safety demonstrated in the randomized, controlled, multicenter RUBY trial, which included 494 patients who were randomized to receive the dostarlimab-gxly regimen or placebo plus carboplatin and paclitaxel, followed by placebo.

Researchers observed a significant improvement in median overall survival with treatment vs placebo in the overall population — 44.6 vs 28.2 months, respectively (hazard ratio [HR], 0.69). Median progression-free survival was also significantly better in the treatment vs placebo group — 11.8 vs 7.9 months, respectively (HR, 0.64).

“Today’s expanded approval will offer even more patients the opportunity for improved outcomes,” Matthew Powell, MD, of Washington University School of Medicine, and principal investigator on the RUBY trial, said in a press release. “This is the only immuno-oncology treatment regimen that has shown a statistically significant overall survival benefit for the full patient population, which is a meaningful step forward in treating this challenging cancer.”

Adverse reactions occurring in at least 20% of patients receiving dostarlimab-gxly include anemia, increased creatinine levels, peripheral neuropathy, decreased white blood cell counts, fatigue, nausea, alopecia, low platelet counts, increased glucose levels, lymphopenia, neutropenia, liver function test abnormalities, arthralgia, rash, constipation, diarrhea, decreased albumin levels, abdominal pain, dyspnea, decreased appetite, increased amylase levels, urinary tract infection, and vomiting. Immune-mediated adverse reactions with dostarlimab-gxly were similar to those previously reported.

The recommended dostarlimab-gxly dose, according to the full prescribing information, is 500 mg every 3 weeks for six cycles administered before carboplatin and paclitaxel if given on the same day, followed by 1000 mg monotherapy every 6 weeks until disease progression or unacceptable toxicity, or up to 3 years.
 

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

TOPLINE:

Oncologists show significant variability in prescribing systemic cancer therapies in the last 30 days of life. Patients treated by oncologists in the top quartile for end-of-life prescribing behavior were almost four and a half times more likely to receive end-of-life therapy than those treated by these specialists in the bottom quartile.

METHODOLOGY:

• Researchers analyzed data from the Surveillance, Epidemiology, and End Results (SEER)-Medicare database, focusing on patients who died of cancer between 2012 and 2017.
• A total of 17,609 patients with breast, lung, colorectal, or prostate cancer were included, treated by 960 oncologists across 388 practices.
• Patients were required to have had at least one systemic cancer therapy claim in the last 180 days of life, with the treating oncologist identified on the basis of the therapy claim closest to the time of death.
• The study used multilevel models to estimate oncologists’ rates of providing cancer therapy in the last 30 days of life, adjusting for patient characteristics and practice variation.
• Functional status was assessed on the basis of paid claims for durable medical equipment in the last 60 months of life, with scores categorized as 0, 1, ≥ 2, or unknown.

TAKEAWAY:

• Oncologists in the 95th percentile for high end-of-life prescribing behavior had a 45% adjusted rate of treating patients in the last 30 days of life, compared with 17% among those in the 5th percentile.
• Patients treated by high end-of-life prescribing oncologists had over four times higher odds of receiving systemic therapy in the last 30 days of life (odds ratio [OR], 4.42; 95% CI, 4.00-4.89).
• Higher end-of-life prescribing oncologists also had a higher proportion of patients hospitalized in the last 30 days of life than low prescribers (58% vs 51.9%).
• No significant association was found between oncologist prescribing behavior and patient race or ethnicity, except for Black patients who had lower odds of receiving treatment (OR, 0.77; P < .001).

IN PRACTICE:

“Given calls to rein in overutilization of end-of-life six to eight cancer therapies, our findings highlight an underappreciated area for further research: How treatment discontinuation before death is shaped by oncologists’ unique treatment propensities. Elucidating the reasons for this remarkable variability in oncologist treatment behavior could inform efforts to reduce end-of-life cancer treatment overutilization,” wrote the authors of the study.

SOURCE:

The study was led by Login S. George, PhD, Institute for Health, Health Care Policy and Aging Research, Rutgers University in New Brunswick, New Jersey. It was published online in Cancer.

LIMITATIONS:

The study’s reliance on SEER-Medicare data may limit the generalizability of the findings to patients with Medicare Advantage, private insurance, or Medicaid, as well as younger patients. The lack of data on patient preferences and other health characteristics could confound the results. The study focused on systemic therapies and may not be generalizable to other treatments such as clinical trial drugs, oral therapies, surgery, or radiation. The data from 2012 to 2017 may not reflect more recent trends in cancer treatment.

DISCLOSURES:

The study was supported by grants from the National Cancer Institute and the Rutgers Cancer Institute of New Jersey. George disclosed receiving grants from these organizations. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Oncologists show significant variability in prescribing systemic cancer therapies in the last 30 days of life. Patients treated by oncologists in the top quartile for end-of-life prescribing behavior were almost four and a half times more likely to receive end-of-life therapy than those treated by these specialists in the bottom quartile.

METHODOLOGY:

• Researchers analyzed data from the Surveillance, Epidemiology, and End Results (SEER)-Medicare database, focusing on patients who died of cancer between 2012 and 2017.
• A total of 17,609 patients with breast, lung, colorectal, or prostate cancer were included, treated by 960 oncologists across 388 practices.
• Patients were required to have had at least one systemic cancer therapy claim in the last 180 days of life, with the treating oncologist identified on the basis of the therapy claim closest to the time of death.
• The study used multilevel models to estimate oncologists’ rates of providing cancer therapy in the last 30 days of life, adjusting for patient characteristics and practice variation.
• Functional status was assessed on the basis of paid claims for durable medical equipment in the last 60 months of life, with scores categorized as 0, 1, ≥ 2, or unknown.

TAKEAWAY:

• Oncologists in the 95th percentile for high end-of-life prescribing behavior had a 45% adjusted rate of treating patients in the last 30 days of life, compared with 17% among those in the 5th percentile.
• Patients treated by high end-of-life prescribing oncologists had over four times higher odds of receiving systemic therapy in the last 30 days of life (odds ratio [OR], 4.42; 95% CI, 4.00-4.89).
• Higher end-of-life prescribing oncologists also had a higher proportion of patients hospitalized in the last 30 days of life than low prescribers (58% vs 51.9%).
• No significant association was found between oncologist prescribing behavior and patient race or ethnicity, except for Black patients who had lower odds of receiving treatment (OR, 0.77; P < .001).

IN PRACTICE:

“Given calls to rein in overutilization of end-of-life six to eight cancer therapies, our findings highlight an underappreciated area for further research: How treatment discontinuation before death is shaped by oncologists’ unique treatment propensities. Elucidating the reasons for this remarkable variability in oncologist treatment behavior could inform efforts to reduce end-of-life cancer treatment overutilization,” wrote the authors of the study.

SOURCE:

The study was led by Login S. George, PhD, Institute for Health, Health Care Policy and Aging Research, Rutgers University in New Brunswick, New Jersey. It was published online in Cancer.

LIMITATIONS:

The study’s reliance on SEER-Medicare data may limit the generalizability of the findings to patients with Medicare Advantage, private insurance, or Medicaid, as well as younger patients. The lack of data on patient preferences and other health characteristics could confound the results. The study focused on systemic therapies and may not be generalizable to other treatments such as clinical trial drugs, oral therapies, surgery, or radiation. The data from 2012 to 2017 may not reflect more recent trends in cancer treatment.

DISCLOSURES:

The study was supported by grants from the National Cancer Institute and the Rutgers Cancer Institute of New Jersey. George disclosed receiving grants from these organizations. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Oncologists show significant variability in prescribing systemic cancer therapies in the last 30 days of life. Patients treated by oncologists in the top quartile for end-of-life prescribing behavior were almost four and a half times more likely to receive end-of-life therapy than those treated by these specialists in the bottom quartile.

METHODOLOGY:

• Researchers analyzed data from the Surveillance, Epidemiology, and End Results (SEER)-Medicare database, focusing on patients who died of cancer between 2012 and 2017.
• A total of 17,609 patients with breast, lung, colorectal, or prostate cancer were included, treated by 960 oncologists across 388 practices.
• Patients were required to have had at least one systemic cancer therapy claim in the last 180 days of life, with the treating oncologist identified on the basis of the therapy claim closest to the time of death.
• The study used multilevel models to estimate oncologists’ rates of providing cancer therapy in the last 30 days of life, adjusting for patient characteristics and practice variation.
• Functional status was assessed on the basis of paid claims for durable medical equipment in the last 60 months of life, with scores categorized as 0, 1, ≥ 2, or unknown.

TAKEAWAY:

• Oncologists in the 95th percentile for high end-of-life prescribing behavior had a 45% adjusted rate of treating patients in the last 30 days of life, compared with 17% among those in the 5th percentile.
• Patients treated by high end-of-life prescribing oncologists had over four times higher odds of receiving systemic therapy in the last 30 days of life (odds ratio [OR], 4.42; 95% CI, 4.00-4.89).
• Higher end-of-life prescribing oncologists also had a higher proportion of patients hospitalized in the last 30 days of life than low prescribers (58% vs 51.9%).
• No significant association was found between oncologist prescribing behavior and patient race or ethnicity, except for Black patients who had lower odds of receiving treatment (OR, 0.77; P < .001).

IN PRACTICE:

“Given calls to rein in overutilization of end-of-life six to eight cancer therapies, our findings highlight an underappreciated area for further research: How treatment discontinuation before death is shaped by oncologists’ unique treatment propensities. Elucidating the reasons for this remarkable variability in oncologist treatment behavior could inform efforts to reduce end-of-life cancer treatment overutilization,” wrote the authors of the study.

SOURCE:

The study was led by Login S. George, PhD, Institute for Health, Health Care Policy and Aging Research, Rutgers University in New Brunswick, New Jersey. It was published online in Cancer.

LIMITATIONS:

The study’s reliance on SEER-Medicare data may limit the generalizability of the findings to patients with Medicare Advantage, private insurance, or Medicaid, as well as younger patients. The lack of data on patient preferences and other health characteristics could confound the results. The study focused on systemic therapies and may not be generalizable to other treatments such as clinical trial drugs, oral therapies, surgery, or radiation. The data from 2012 to 2017 may not reflect more recent trends in cancer treatment.

DISCLOSURES:

The study was supported by grants from the National Cancer Institute and the Rutgers Cancer Institute of New Jersey. George disclosed receiving grants from these organizations. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

More than 5% of cases of sudden infant death may be linked to maternal obesity, new research showed.

“When a parent has a child that dies of sudden unexplained infant death [SUID], it’s extremely devastating,” said Jan-Marino Ramirez, PhD, the Zain Nadella Endowed Chair in Pediatric Neurosciences at the University of Washington, Seattle, and director of the Center for Integrative Brain Research at Seattle Children’s Hospital. “And the most devastating problem is that there’s no clear answer. Understanding the mechanisms will help parents understand.”

The study was published online in JAMA Pediatrics.

In the United States, approximately 3500 cases of SUID are reported yearly. After educational campaigns in the 1990s demonstrating safe infant sleep positions, rates of these fatalities dropped but have since plateaued.
 

Maternal Obesity During Pregnancy

Rates of maternal obesity are increasing globally, and more than half of women of reproductive age are overweight or obese.

“Maternal obesity before pregnancy affects placental development, gene expression, and has long-term implications,” said Patrick Catalano, MD, a professor in residence at the Departments of Reproductive Endocrinology and Obstetrics and Gynecology at Massachusetts General Hospital and Harvard Medical School in Boston.

Maternal obesity is a well-documented risk factor for adverse outcomes of pregnancy including stillbirth, preterm birth, and admission to the neonatal intensive care unit. Swedish researchers in 2014 reported maternal obesity was linked to an increase in infant mortality that increased with body mass index (BMI), but that study did not look specifically at SUID.

For their new study, Dr. Ramirez and colleagues looked at data from all live births in the United States from 2015 to 2019 recorded by the Centers for Disease Control and Prevention and the National Center for Health Statistics. Of the 18,857,694 live births occurring at 28 weeks of gestation or later, 16,545 infants died of a sudden, unexplained cause.

Rates of SUID in babies born to mothers with obesity increased in a statistically significant, dose-dependent manner relative to normal weight mothers. The unadjusted absolute risks for SUID were 0.74 cases per 1000 births for normal weight mothers, 0.99 cases at BMIs between 30 and 35, 1.17 cases at BMIs between 35 and 40, and 1.47 instances at BMI ≥ 40.

After adjustment for maternal age, race, ethnicity, and level of education, the adjusted odds ratio for a case of SUID was 1.39 among women with the highest levels of obesity (95% CI, 1.31-1.47), according to the researchers.

While the study revealed an association between maternal obesity and SUID, the basis for this connection remains unknown, the investigators noted. One possibility for the link is that obesity increases the risk for obstructive sleep apnea, which can result in intermittent hypoxia. That, in turn, causes oxidative stress, which may possibly have effects on the fetus causing effects that eventually lead to SUID in the infant.

An accompanying editorial by Jacqueline Maya, MD; Marie-France Hivert, MD, MMSc; and Lydia Shook, MD, from the Massachusetts General Hospital and Harvard Medical School, suggested that the SUID is unlikely directly influenced by high maternal BMI but rather by the metabolic concerns related to obesity such as inflammation, insulin resistance, and abnormal lipid metabolism. Epigenetics may also play a role.

“We believe the evidence for this study of an association between prepregnancy obesity and SUID is a call to action for the scientific and medical community to better understand the complex interplay of biological, social, and behavioral factors that may lead to SUID, a devastating complication that no family should experience,” the authors of the editorial wrote.

Dr. Ramirez stressed the importance of not initiating guilt because there are many factors in SUID such as genetics that cannot be controlled.

“We are far from saying a baby died because you were obese; that’s an important message to parents,” he said. What he sees as important, rather, is using this new research to elucidate further mechanisms that may allow for more targeted interventions: “If we discover that it’s due to, for example, sleep apnea, that’s something we can prevent.”

The researchers reported no conflicts of interest.

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

More than 5% of cases of sudden infant death may be linked to maternal obesity, new research showed.

“When a parent has a child that dies of sudden unexplained infant death [SUID], it’s extremely devastating,” said Jan-Marino Ramirez, PhD, the Zain Nadella Endowed Chair in Pediatric Neurosciences at the University of Washington, Seattle, and director of the Center for Integrative Brain Research at Seattle Children’s Hospital. “And the most devastating problem is that there’s no clear answer. Understanding the mechanisms will help parents understand.”

The study was published online in JAMA Pediatrics.

In the United States, approximately 3500 cases of SUID are reported yearly. After educational campaigns in the 1990s demonstrating safe infant sleep positions, rates of these fatalities dropped but have since plateaued.
 

Maternal Obesity During Pregnancy

Rates of maternal obesity are increasing globally, and more than half of women of reproductive age are overweight or obese.

“Maternal obesity before pregnancy affects placental development, gene expression, and has long-term implications,” said Patrick Catalano, MD, a professor in residence at the Departments of Reproductive Endocrinology and Obstetrics and Gynecology at Massachusetts General Hospital and Harvard Medical School in Boston.

Maternal obesity is a well-documented risk factor for adverse outcomes of pregnancy including stillbirth, preterm birth, and admission to the neonatal intensive care unit. Swedish researchers in 2014 reported maternal obesity was linked to an increase in infant mortality that increased with body mass index (BMI), but that study did not look specifically at SUID.

For their new study, Dr. Ramirez and colleagues looked at data from all live births in the United States from 2015 to 2019 recorded by the Centers for Disease Control and Prevention and the National Center for Health Statistics. Of the 18,857,694 live births occurring at 28 weeks of gestation or later, 16,545 infants died of a sudden, unexplained cause.

Rates of SUID in babies born to mothers with obesity increased in a statistically significant, dose-dependent manner relative to normal weight mothers. The unadjusted absolute risks for SUID were 0.74 cases per 1000 births for normal weight mothers, 0.99 cases at BMIs between 30 and 35, 1.17 cases at BMIs between 35 and 40, and 1.47 instances at BMI ≥ 40.

After adjustment for maternal age, race, ethnicity, and level of education, the adjusted odds ratio for a case of SUID was 1.39 among women with the highest levels of obesity (95% CI, 1.31-1.47), according to the researchers.

While the study revealed an association between maternal obesity and SUID, the basis for this connection remains unknown, the investigators noted. One possibility for the link is that obesity increases the risk for obstructive sleep apnea, which can result in intermittent hypoxia. That, in turn, causes oxidative stress, which may possibly have effects on the fetus causing effects that eventually lead to SUID in the infant.

An accompanying editorial by Jacqueline Maya, MD; Marie-France Hivert, MD, MMSc; and Lydia Shook, MD, from the Massachusetts General Hospital and Harvard Medical School, suggested that the SUID is unlikely directly influenced by high maternal BMI but rather by the metabolic concerns related to obesity such as inflammation, insulin resistance, and abnormal lipid metabolism. Epigenetics may also play a role.

“We believe the evidence for this study of an association between prepregnancy obesity and SUID is a call to action for the scientific and medical community to better understand the complex interplay of biological, social, and behavioral factors that may lead to SUID, a devastating complication that no family should experience,” the authors of the editorial wrote.

Dr. Ramirez stressed the importance of not initiating guilt because there are many factors in SUID such as genetics that cannot be controlled.

“We are far from saying a baby died because you were obese; that’s an important message to parents,” he said. What he sees as important, rather, is using this new research to elucidate further mechanisms that may allow for more targeted interventions: “If we discover that it’s due to, for example, sleep apnea, that’s something we can prevent.”

The researchers reported no conflicts of interest.

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

More than 5% of cases of sudden infant death may be linked to maternal obesity, new research showed.

“When a parent has a child that dies of sudden unexplained infant death [SUID], it’s extremely devastating,” said Jan-Marino Ramirez, PhD, the Zain Nadella Endowed Chair in Pediatric Neurosciences at the University of Washington, Seattle, and director of the Center for Integrative Brain Research at Seattle Children’s Hospital. “And the most devastating problem is that there’s no clear answer. Understanding the mechanisms will help parents understand.”

The study was published online in JAMA Pediatrics.

In the United States, approximately 3500 cases of SUID are reported yearly. After educational campaigns in the 1990s demonstrating safe infant sleep positions, rates of these fatalities dropped but have since plateaued.
 

Maternal Obesity During Pregnancy

Rates of maternal obesity are increasing globally, and more than half of women of reproductive age are overweight or obese.

“Maternal obesity before pregnancy affects placental development, gene expression, and has long-term implications,” said Patrick Catalano, MD, a professor in residence at the Departments of Reproductive Endocrinology and Obstetrics and Gynecology at Massachusetts General Hospital and Harvard Medical School in Boston.

Maternal obesity is a well-documented risk factor for adverse outcomes of pregnancy including stillbirth, preterm birth, and admission to the neonatal intensive care unit. Swedish researchers in 2014 reported maternal obesity was linked to an increase in infant mortality that increased with body mass index (BMI), but that study did not look specifically at SUID.

For their new study, Dr. Ramirez and colleagues looked at data from all live births in the United States from 2015 to 2019 recorded by the Centers for Disease Control and Prevention and the National Center for Health Statistics. Of the 18,857,694 live births occurring at 28 weeks of gestation or later, 16,545 infants died of a sudden, unexplained cause.

Rates of SUID in babies born to mothers with obesity increased in a statistically significant, dose-dependent manner relative to normal weight mothers. The unadjusted absolute risks for SUID were 0.74 cases per 1000 births for normal weight mothers, 0.99 cases at BMIs between 30 and 35, 1.17 cases at BMIs between 35 and 40, and 1.47 instances at BMI ≥ 40.

After adjustment for maternal age, race, ethnicity, and level of education, the adjusted odds ratio for a case of SUID was 1.39 among women with the highest levels of obesity (95% CI, 1.31-1.47), according to the researchers.

While the study revealed an association between maternal obesity and SUID, the basis for this connection remains unknown, the investigators noted. One possibility for the link is that obesity increases the risk for obstructive sleep apnea, which can result in intermittent hypoxia. That, in turn, causes oxidative stress, which may possibly have effects on the fetus causing effects that eventually lead to SUID in the infant.

An accompanying editorial by Jacqueline Maya, MD; Marie-France Hivert, MD, MMSc; and Lydia Shook, MD, from the Massachusetts General Hospital and Harvard Medical School, suggested that the SUID is unlikely directly influenced by high maternal BMI but rather by the metabolic concerns related to obesity such as inflammation, insulin resistance, and abnormal lipid metabolism. Epigenetics may also play a role.

“We believe the evidence for this study of an association between prepregnancy obesity and SUID is a call to action for the scientific and medical community to better understand the complex interplay of biological, social, and behavioral factors that may lead to SUID, a devastating complication that no family should experience,” the authors of the editorial wrote.

Dr. Ramirez stressed the importance of not initiating guilt because there are many factors in SUID such as genetics that cannot be controlled.

“We are far from saying a baby died because you were obese; that’s an important message to parents,” he said. What he sees as important, rather, is using this new research to elucidate further mechanisms that may allow for more targeted interventions: “If we discover that it’s due to, for example, sleep apnea, that’s something we can prevent.”

The researchers reported no conflicts of interest.