Ob.Gyn. News

Editor’s Note: Sadly, this is the last column in the Master Class Obstetrics series. This award-winning column has been part of Ob.Gyn. News for 20 years. The deep discussion of cutting-edge topics in obstetrics by specialists and researchers will be missed as will the leadership and curation of topics by Dr. E. Albert Reece.
 

Introduction: The Need for Increased Vigilance About Maternal Immunization

Viruses are becoming increasingly prevalent in our world and the consequences of viral infections are implicated in a growing number of disease states. It is well established that certain cancers are caused by viruses and it is increasingly evident that viral infections can trigger the development of chronic illness. In pregnant women, viruses such as cytomegalovirus can cause infection in utero and lead to long-term impairments for the baby.

Likewise, it appears that the virulence of viruses is increasing, whether it be the respiratory syncytial virus (RSV) in children or the severe acute respiratory syndrome (SARS) coronaviruses in adults. Clearly, our environment is changing, with increases in population growth and urbanization, for instance, and an intensification of climate change and its effects. Viruses are part of this changing background.

Dr. Reece is the former Dean of Medicine & University Executive VP, and The Distinguished University and Endowed Professor & Director of the Center for Advanced Research Training and Innovation (CARTI) at the University of Maryland School of Medicine, as well as senior scientist at the Center for Birth Defects Research.

The alarming decline in maternal immunization rates that occurred in the wake of the COVID-19 pandemic means that, now more than ever, we must fully embrace our responsibility to recommend immunizations in pregnancy and to communicate what is known about their efficacy and safety. Data show that vaccination rates drop when we do not offer vaccines in our offices, so whenever possible, we should administer them as well.

The ob.gyn. is the patient’s most trusted person in pregnancy. When patients decline or express hesitancy about vaccines, it is incumbent upon us to ask why. Oftentimes, we can identify areas in which patients lack knowledge or have misperceptions and we can successfully educate the patient or change their perspective or misunderstanding concerning the importance of vaccination for themselves and their babies. (See Table 1.) We can also successfully address concerns about safety.

Dr. Riley

New York Presbyterian

Counseling About Influenza and COVID-19 Vaccination

The COVID-19 pandemic took a toll on vaccination interest/receptivity broadly in pregnant and nonpregnant people. Among pregnant individuals, influenza vaccination coverage declined from 71% in the 2019-2020 influenza season to 56% in the 2021-2022 season, according to data from the Centers for Disease Control and Prevention’s Vaccine Safety Datalink.⁴ Coverage for the 2022-2023 and 2023-2024 influenza seasons was even worse: well under 50%.⁵

Fewer pregnant women have received updated COVID-19 vaccines. Only 13% of pregnant persons overall received the updated 2023-2024 COVID-19 booster vaccine (through March 30, 2024), according to the CDC.⁶

Maternal immunization for influenza has been recommended in the United States since 2004 (part of the recommendation that everyone over the age of 6 months receive an annual flu vaccine), and flu vaccines have been given to millions of pregnant women, but the H1N1 pandemic of 2009 reinforced its value as a priority for prenatal care. Most of the women who became severely ill from the H1N1 virus were young and healthy, without co-existing conditions known to increase risk.⁷

It became clearer during the H1N1 pandemic that pregnancy itself — which is associated with physiologic changes such as decreased lung capacity, increased nasal congestion and changes in the immune system – is its own significant risk factor for severe illness from the influenza virus. This increased risk applies to COVID-19 as well.

As COVID-19 has become endemic, with hospitalizations and deaths not reaching the levels of previous surges — and with mask-wearing and other preventive measures having declined — patients understandably have become more complacent. Some patients are vaccine deniers, but in my practice, these patients are a much smaller group than those who believe COVID-19 “is no big deal,” especially if they have had infections recently.

This is why it’s important to actively listen to concerns and to ask patients who decline a vaccination why they are hesitant. Blanket messages about vaccine efficacy and safety are the first step, but individualized, more pointed conversations based on the patient’s personal experiences and beliefs have become increasingly important.

I routinely tell pregnant patients about the risks of COVID-19 and I explain that it has been difficult to predict who will develop severe illness. Sometimes more conversation is needed. For those who are still hesitant or who tell me they feel protected by a recent infection, for instance, I provide more detail on the unique risks of pregnancy — the fact that “pregnancy is different” — and that natural immunity wanes while the protection afforded by immunization is believed to last longer. Many women are also concerned about the safety of the COVID-19 vaccine, so having safety data at your fingertips is helpful. (See Table 2.)

Dr. Riley

Counseling About RSV Vaccination

Importantly, for the 2024-2025 RSV season, the maternal RSV vaccine (Abrysvo, Pfizer) is recommended only for pregnant women who did not receive the vaccine during the 2023-2024 season. When more research is done and more data are obtained showing how long the immune response persists post vaccination, it may be that the US Food and Drug Administration (FDA) will approve the maternal RSV vaccine for use in every pregnancy.

The later timing of the vaccination recommendation — 32-36 weeks’ gestation — reflects a conservative approach taken by the FDA in response to data from one of the pivotal trials showing a numerical trend toward more preterm deliveries among vaccinated compared with unvaccinated patients. This imbalance in the original trial, which administered the vaccine during 24-36 weeks of gestation, was seen only in low-income countries with no temporal association, however.

In our experience at two Weill Cornell Medical College–associated hospitals we did not see this trend. Our cohort study of almost 3000 pregnant patients who delivered at 32 weeks’ gestation or later found no increased risk of preterm birth among the 35% of patients who received the RSV vaccine during the 2023-2024 RSV season. We also did not see any difference in preeclampsia, in contrast with original trial data that showed a signal for increased risk.¹¹

When fewer than 2 weeks have elapsed between maternal vaccination and delivery, the monoclonal antibody nirsevimab is recommended for the newborn — ideally before the newborn leaves the hospital. Nirsevimab is also recommended for newborns of mothers who decline vaccination or were not candidates (e.g. vaccinated in a previous pregnancy), or when there is concern about the adequacy of the maternal immune response to the vaccine (e.g. in cases of immunosuppression).

While there was a limited supply of the monoclonal antibody last year, limitations are not expected this year, especially after October.

The ultimate goal is that patients choose the vaccine or the immunoglobulin, given the severity of RSV disease. Patient preferences should be considered. However, given that it takes 2 weeks after vaccination for protection to build up, I stress to patients that if they’ve vaccinated themselves, their newborn will leave the hospital with protection. If nirsevimab is relied upon, I explain, their newborn may not be protected for some period of time.
 

Take-home Messages

• When patients decline or are hesitant about vaccines, ask why. Listen actively, and work to correct misperceptions and knowledge gaps.
• Whenever possible, offer vaccines in your practice. Vaccination rates drop when this does not occur.
• COVID-vaccine safety is backed by many studies showing no increase in birth defects, preterm delivery, miscarriage, or stillbirth.
• Pregnant women are more likely to have severe illness from the influenza and SARS-CoV-2 viruses. Vaccines can prevent severe illness and can protect the newborn as well as the mother.
• Recommend/administer the maternal RSV vaccine at 32-36 weeks’ gestation in women who did not receive the vaccine in the 2023-2024 season. If mothers aren’t eligible their babies should be offered nirsevimab.

Dr. Riley is the Given Foundation Professor and Chair of Obstetrics and Gynecology at Weill Cornell Medicine and the obstetrician and gynecologist-in-chief at New York Presbyterian Hospital. She disclosed that she has provided one-time consultations to Pfizer (Abrysvo RSV vaccine) and GSK (cytomegalovirus vaccine), and is providing consultant education on CMV for Moderna. She is chair of ACOG’s task force on immunization and emerging infectious diseases, serves on the medical advisory board for MAVEN, and serves as an editor or editorial board member for several medical publications.



References

1. ACOG Committee Opinion No. 741: Maternal Immunization. Obstet Gynecol. 2018;131(6):e214-e217.

2. Centers for Disease Control and Prevention. COVID-19 Vaccination for People Who are Pregnant or Breastfeeding. https://www.cdc.gov/covid/vaccines/pregnant-or-breastfeeding.html.

3. ACOG Practice Advisory on Maternal Respiratory Syncytial Virus Vaccination, September 2023. (Updated August 2024).4. Irving S et al. Open Forum Infect Dis. 2023;10(Suppl 2):ofad500.1002.

5. Flu Vaccination Dashboard, CDC, National Center for Immunization and Respiratory Diseases.

6. Weekly COVID-19 Vaccination Dashboard, CDC. https://www.cdc.gov/covidvaxview/weekly-dashboard/index.html

7. Louie JK et al. N Engl J Med. 2010;362:27-35. 8. Ciapponi A et al. Vaccine. 2021;39(40):5891-908.

9. Prasad S et al. Nature Communications. 2022;13:2414. 10. Fleming-Dutra KE et al. Obstet Gynecol Clin North Am 2023;50(2):279-97. 11. Mouen S et al. JAMA Network Open 2024;7(7):e2419268.

Editor’s Note: Sadly, this is the last column in the Master Class Obstetrics series. This award-winning column has been part of Ob.Gyn. News for 20 years. The deep discussion of cutting-edge topics in obstetrics by specialists and researchers will be missed as will the leadership and curation of topics by Dr. E. Albert Reece.
 

Introduction: The Need for Increased Vigilance About Maternal Immunization

Viruses are becoming increasingly prevalent in our world and the consequences of viral infections are implicated in a growing number of disease states. It is well established that certain cancers are caused by viruses and it is increasingly evident that viral infections can trigger the development of chronic illness. In pregnant women, viruses such as cytomegalovirus can cause infection in utero and lead to long-term impairments for the baby.

Likewise, it appears that the virulence of viruses is increasing, whether it be the respiratory syncytial virus (RSV) in children or the severe acute respiratory syndrome (SARS) coronaviruses in adults. Clearly, our environment is changing, with increases in population growth and urbanization, for instance, and an intensification of climate change and its effects. Viruses are part of this changing background.

Dr. Reece is the former Dean of Medicine & University Executive VP, and The Distinguished University and Endowed Professor & Director of the Center for Advanced Research Training and Innovation (CARTI) at the University of Maryland School of Medicine, as well as senior scientist at the Center for Birth Defects Research.

The alarming decline in maternal immunization rates that occurred in the wake of the COVID-19 pandemic means that, now more than ever, we must fully embrace our responsibility to recommend immunizations in pregnancy and to communicate what is known about their efficacy and safety. Data show that vaccination rates drop when we do not offer vaccines in our offices, so whenever possible, we should administer them as well.

The ob.gyn. is the patient’s most trusted person in pregnancy. When patients decline or express hesitancy about vaccines, it is incumbent upon us to ask why. Oftentimes, we can identify areas in which patients lack knowledge or have misperceptions and we can successfully educate the patient or change their perspective or misunderstanding concerning the importance of vaccination for themselves and their babies. (See Table 1.) We can also successfully address concerns about safety.

Dr. Riley

New York Presbyterian

Counseling About Influenza and COVID-19 Vaccination

The COVID-19 pandemic took a toll on vaccination interest/receptivity broadly in pregnant and nonpregnant people. Among pregnant individuals, influenza vaccination coverage declined from 71% in the 2019-2020 influenza season to 56% in the 2021-2022 season, according to data from the Centers for Disease Control and Prevention’s Vaccine Safety Datalink.⁴ Coverage for the 2022-2023 and 2023-2024 influenza seasons was even worse: well under 50%.⁵

Fewer pregnant women have received updated COVID-19 vaccines. Only 13% of pregnant persons overall received the updated 2023-2024 COVID-19 booster vaccine (through March 30, 2024), according to the CDC.⁶

Maternal immunization for influenza has been recommended in the United States since 2004 (part of the recommendation that everyone over the age of 6 months receive an annual flu vaccine), and flu vaccines have been given to millions of pregnant women, but the H1N1 pandemic of 2009 reinforced its value as a priority for prenatal care. Most of the women who became severely ill from the H1N1 virus were young and healthy, without co-existing conditions known to increase risk.⁷

It became clearer during the H1N1 pandemic that pregnancy itself — which is associated with physiologic changes such as decreased lung capacity, increased nasal congestion and changes in the immune system – is its own significant risk factor for severe illness from the influenza virus. This increased risk applies to COVID-19 as well.

As COVID-19 has become endemic, with hospitalizations and deaths not reaching the levels of previous surges — and with mask-wearing and other preventive measures having declined — patients understandably have become more complacent. Some patients are vaccine deniers, but in my practice, these patients are a much smaller group than those who believe COVID-19 “is no big deal,” especially if they have had infections recently.

This is why it’s important to actively listen to concerns and to ask patients who decline a vaccination why they are hesitant. Blanket messages about vaccine efficacy and safety are the first step, but individualized, more pointed conversations based on the patient’s personal experiences and beliefs have become increasingly important.

I routinely tell pregnant patients about the risks of COVID-19 and I explain that it has been difficult to predict who will develop severe illness. Sometimes more conversation is needed. For those who are still hesitant or who tell me they feel protected by a recent infection, for instance, I provide more detail on the unique risks of pregnancy — the fact that “pregnancy is different” — and that natural immunity wanes while the protection afforded by immunization is believed to last longer. Many women are also concerned about the safety of the COVID-19 vaccine, so having safety data at your fingertips is helpful. (See Table 2.)

Dr. Riley

Counseling About RSV Vaccination

Importantly, for the 2024-2025 RSV season, the maternal RSV vaccine (Abrysvo, Pfizer) is recommended only for pregnant women who did not receive the vaccine during the 2023-2024 season. When more research is done and more data are obtained showing how long the immune response persists post vaccination, it may be that the US Food and Drug Administration (FDA) will approve the maternal RSV vaccine for use in every pregnancy.

The later timing of the vaccination recommendation — 32-36 weeks’ gestation — reflects a conservative approach taken by the FDA in response to data from one of the pivotal trials showing a numerical trend toward more preterm deliveries among vaccinated compared with unvaccinated patients. This imbalance in the original trial, which administered the vaccine during 24-36 weeks of gestation, was seen only in low-income countries with no temporal association, however.

In our experience at two Weill Cornell Medical College–associated hospitals we did not see this trend. Our cohort study of almost 3000 pregnant patients who delivered at 32 weeks’ gestation or later found no increased risk of preterm birth among the 35% of patients who received the RSV vaccine during the 2023-2024 RSV season. We also did not see any difference in preeclampsia, in contrast with original trial data that showed a signal for increased risk.¹¹

When fewer than 2 weeks have elapsed between maternal vaccination and delivery, the monoclonal antibody nirsevimab is recommended for the newborn — ideally before the newborn leaves the hospital. Nirsevimab is also recommended for newborns of mothers who decline vaccination or were not candidates (e.g. vaccinated in a previous pregnancy), or when there is concern about the adequacy of the maternal immune response to the vaccine (e.g. in cases of immunosuppression).

While there was a limited supply of the monoclonal antibody last year, limitations are not expected this year, especially after October.

The ultimate goal is that patients choose the vaccine or the immunoglobulin, given the severity of RSV disease. Patient preferences should be considered. However, given that it takes 2 weeks after vaccination for protection to build up, I stress to patients that if they’ve vaccinated themselves, their newborn will leave the hospital with protection. If nirsevimab is relied upon, I explain, their newborn may not be protected for some period of time.
 

Take-home Messages

• When patients decline or are hesitant about vaccines, ask why. Listen actively, and work to correct misperceptions and knowledge gaps.
• Whenever possible, offer vaccines in your practice. Vaccination rates drop when this does not occur.
• COVID-vaccine safety is backed by many studies showing no increase in birth defects, preterm delivery, miscarriage, or stillbirth.
• Pregnant women are more likely to have severe illness from the influenza and SARS-CoV-2 viruses. Vaccines can prevent severe illness and can protect the newborn as well as the mother.
• Recommend/administer the maternal RSV vaccine at 32-36 weeks’ gestation in women who did not receive the vaccine in the 2023-2024 season. If mothers aren’t eligible their babies should be offered nirsevimab.

Dr. Riley is the Given Foundation Professor and Chair of Obstetrics and Gynecology at Weill Cornell Medicine and the obstetrician and gynecologist-in-chief at New York Presbyterian Hospital. She disclosed that she has provided one-time consultations to Pfizer (Abrysvo RSV vaccine) and GSK (cytomegalovirus vaccine), and is providing consultant education on CMV for Moderna. She is chair of ACOG’s task force on immunization and emerging infectious diseases, serves on the medical advisory board for MAVEN, and serves as an editor or editorial board member for several medical publications.



References

1. ACOG Committee Opinion No. 741: Maternal Immunization. Obstet Gynecol. 2018;131(6):e214-e217.

2. Centers for Disease Control and Prevention. COVID-19 Vaccination for People Who are Pregnant or Breastfeeding. https://www.cdc.gov/covid/vaccines/pregnant-or-breastfeeding.html.

3. ACOG Practice Advisory on Maternal Respiratory Syncytial Virus Vaccination, September 2023. (Updated August 2024).4. Irving S et al. Open Forum Infect Dis. 2023;10(Suppl 2):ofad500.1002.

5. Flu Vaccination Dashboard, CDC, National Center for Immunization and Respiratory Diseases.

6. Weekly COVID-19 Vaccination Dashboard, CDC. https://www.cdc.gov/covidvaxview/weekly-dashboard/index.html

7. Louie JK et al. N Engl J Med. 2010;362:27-35. 8. Ciapponi A et al. Vaccine. 2021;39(40):5891-908.

9. Prasad S et al. Nature Communications. 2022;13:2414. 10. Fleming-Dutra KE et al. Obstet Gynecol Clin North Am 2023;50(2):279-97. 11. Mouen S et al. JAMA Network Open 2024;7(7):e2419268.

Editor’s Note: Sadly, this is the last column in the Master Class Obstetrics series. This award-winning column has been part of Ob.Gyn. News for 20 years. The deep discussion of cutting-edge topics in obstetrics by specialists and researchers will be missed as will the leadership and curation of topics by Dr. E. Albert Reece.
 

Introduction: The Need for Increased Vigilance About Maternal Immunization

Viruses are becoming increasingly prevalent in our world and the consequences of viral infections are implicated in a growing number of disease states. It is well established that certain cancers are caused by viruses and it is increasingly evident that viral infections can trigger the development of chronic illness. In pregnant women, viruses such as cytomegalovirus can cause infection in utero and lead to long-term impairments for the baby.

Likewise, it appears that the virulence of viruses is increasing, whether it be the respiratory syncytial virus (RSV) in children or the severe acute respiratory syndrome (SARS) coronaviruses in adults. Clearly, our environment is changing, with increases in population growth and urbanization, for instance, and an intensification of climate change and its effects. Viruses are part of this changing background.

Dr. Reece is the former Dean of Medicine & University Executive VP, and The Distinguished University and Endowed Professor & Director of the Center for Advanced Research Training and Innovation (CARTI) at the University of Maryland School of Medicine, as well as senior scientist at the Center for Birth Defects Research.

The alarming decline in maternal immunization rates that occurred in the wake of the COVID-19 pandemic means that, now more than ever, we must fully embrace our responsibility to recommend immunizations in pregnancy and to communicate what is known about their efficacy and safety. Data show that vaccination rates drop when we do not offer vaccines in our offices, so whenever possible, we should administer them as well.

The ob.gyn. is the patient’s most trusted person in pregnancy. When patients decline or express hesitancy about vaccines, it is incumbent upon us to ask why. Oftentimes, we can identify areas in which patients lack knowledge or have misperceptions and we can successfully educate the patient or change their perspective or misunderstanding concerning the importance of vaccination for themselves and their babies. (See Table 1.) We can also successfully address concerns about safety.

Dr. Riley

New York Presbyterian

Counseling About Influenza and COVID-19 Vaccination

The COVID-19 pandemic took a toll on vaccination interest/receptivity broadly in pregnant and nonpregnant people. Among pregnant individuals, influenza vaccination coverage declined from 71% in the 2019-2020 influenza season to 56% in the 2021-2022 season, according to data from the Centers for Disease Control and Prevention’s Vaccine Safety Datalink.⁴ Coverage for the 2022-2023 and 2023-2024 influenza seasons was even worse: well under 50%.⁵

Fewer pregnant women have received updated COVID-19 vaccines. Only 13% of pregnant persons overall received the updated 2023-2024 COVID-19 booster vaccine (through March 30, 2024), according to the CDC.⁶

Maternal immunization for influenza has been recommended in the United States since 2004 (part of the recommendation that everyone over the age of 6 months receive an annual flu vaccine), and flu vaccines have been given to millions of pregnant women, but the H1N1 pandemic of 2009 reinforced its value as a priority for prenatal care. Most of the women who became severely ill from the H1N1 virus were young and healthy, without co-existing conditions known to increase risk.⁷

It became clearer during the H1N1 pandemic that pregnancy itself — which is associated with physiologic changes such as decreased lung capacity, increased nasal congestion and changes in the immune system – is its own significant risk factor for severe illness from the influenza virus. This increased risk applies to COVID-19 as well.

As COVID-19 has become endemic, with hospitalizations and deaths not reaching the levels of previous surges — and with mask-wearing and other preventive measures having declined — patients understandably have become more complacent. Some patients are vaccine deniers, but in my practice, these patients are a much smaller group than those who believe COVID-19 “is no big deal,” especially if they have had infections recently.

This is why it’s important to actively listen to concerns and to ask patients who decline a vaccination why they are hesitant. Blanket messages about vaccine efficacy and safety are the first step, but individualized, more pointed conversations based on the patient’s personal experiences and beliefs have become increasingly important.

I routinely tell pregnant patients about the risks of COVID-19 and I explain that it has been difficult to predict who will develop severe illness. Sometimes more conversation is needed. For those who are still hesitant or who tell me they feel protected by a recent infection, for instance, I provide more detail on the unique risks of pregnancy — the fact that “pregnancy is different” — and that natural immunity wanes while the protection afforded by immunization is believed to last longer. Many women are also concerned about the safety of the COVID-19 vaccine, so having safety data at your fingertips is helpful. (See Table 2.)

Dr. Riley

Counseling About RSV Vaccination

Importantly, for the 2024-2025 RSV season, the maternal RSV vaccine (Abrysvo, Pfizer) is recommended only for pregnant women who did not receive the vaccine during the 2023-2024 season. When more research is done and more data are obtained showing how long the immune response persists post vaccination, it may be that the US Food and Drug Administration (FDA) will approve the maternal RSV vaccine for use in every pregnancy.

The later timing of the vaccination recommendation — 32-36 weeks’ gestation — reflects a conservative approach taken by the FDA in response to data from one of the pivotal trials showing a numerical trend toward more preterm deliveries among vaccinated compared with unvaccinated patients. This imbalance in the original trial, which administered the vaccine during 24-36 weeks of gestation, was seen only in low-income countries with no temporal association, however.

In our experience at two Weill Cornell Medical College–associated hospitals we did not see this trend. Our cohort study of almost 3000 pregnant patients who delivered at 32 weeks’ gestation or later found no increased risk of preterm birth among the 35% of patients who received the RSV vaccine during the 2023-2024 RSV season. We also did not see any difference in preeclampsia, in contrast with original trial data that showed a signal for increased risk.¹¹

When fewer than 2 weeks have elapsed between maternal vaccination and delivery, the monoclonal antibody nirsevimab is recommended for the newborn — ideally before the newborn leaves the hospital. Nirsevimab is also recommended for newborns of mothers who decline vaccination or were not candidates (e.g. vaccinated in a previous pregnancy), or when there is concern about the adequacy of the maternal immune response to the vaccine (e.g. in cases of immunosuppression).

While there was a limited supply of the monoclonal antibody last year, limitations are not expected this year, especially after October.

The ultimate goal is that patients choose the vaccine or the immunoglobulin, given the severity of RSV disease. Patient preferences should be considered. However, given that it takes 2 weeks after vaccination for protection to build up, I stress to patients that if they’ve vaccinated themselves, their newborn will leave the hospital with protection. If nirsevimab is relied upon, I explain, their newborn may not be protected for some period of time.
 

Take-home Messages

• When patients decline or are hesitant about vaccines, ask why. Listen actively, and work to correct misperceptions and knowledge gaps.
• Whenever possible, offer vaccines in your practice. Vaccination rates drop when this does not occur.
• COVID-vaccine safety is backed by many studies showing no increase in birth defects, preterm delivery, miscarriage, or stillbirth.
• Pregnant women are more likely to have severe illness from the influenza and SARS-CoV-2 viruses. Vaccines can prevent severe illness and can protect the newborn as well as the mother.
• Recommend/administer the maternal RSV vaccine at 32-36 weeks’ gestation in women who did not receive the vaccine in the 2023-2024 season. If mothers aren’t eligible their babies should be offered nirsevimab.

Dr. Riley is the Given Foundation Professor and Chair of Obstetrics and Gynecology at Weill Cornell Medicine and the obstetrician and gynecologist-in-chief at New York Presbyterian Hospital. She disclosed that she has provided one-time consultations to Pfizer (Abrysvo RSV vaccine) and GSK (cytomegalovirus vaccine), and is providing consultant education on CMV for Moderna. She is chair of ACOG’s task force on immunization and emerging infectious diseases, serves on the medical advisory board for MAVEN, and serves as an editor or editorial board member for several medical publications.



References

1. ACOG Committee Opinion No. 741: Maternal Immunization. Obstet Gynecol. 2018;131(6):e214-e217.

2. Centers for Disease Control and Prevention. COVID-19 Vaccination for People Who are Pregnant or Breastfeeding. https://www.cdc.gov/covid/vaccines/pregnant-or-breastfeeding.html.

3. ACOG Practice Advisory on Maternal Respiratory Syncytial Virus Vaccination, September 2023. (Updated August 2024).4. Irving S et al. Open Forum Infect Dis. 2023;10(Suppl 2):ofad500.1002.

5. Flu Vaccination Dashboard, CDC, National Center for Immunization and Respiratory Diseases.

6. Weekly COVID-19 Vaccination Dashboard, CDC. https://www.cdc.gov/covidvaxview/weekly-dashboard/index.html

7. Louie JK et al. N Engl J Med. 2010;362:27-35. 8. Ciapponi A et al. Vaccine. 2021;39(40):5891-908.

9. Prasad S et al. Nature Communications. 2022;13:2414. 10. Fleming-Dutra KE et al. Obstet Gynecol Clin North Am 2023;50(2):279-97. 11. Mouen S et al. JAMA Network Open 2024;7(7):e2419268.

Thanks to the continuously improving treatment options for cancer, the number of cancer survivors is increasing, and a large proportion of survivors is confronted with the long-term effects of cancer treatment. Especially for young patients, the question of the impact of therapy on fertility arises.

Dose adjustment or modification of the treatment regimen can achieve a lot. But experts at the congress of the European Society for Medical Oncology (ESMO) 2024 noted that knowledge about newer treatment options like immunotherapies is still insufficient.
 

Therapy Selection

The question of preserving fertility must be considered when deciding on the appropriate treatment, said Matteo Lambertini, MD, PhD, medical oncology consultant at the University of Genoa in Genoa, Italy. A patient’s age, the type of therapy, and the dose are crucial in determining whether or how much fertility is affected. “Preserving fertility is also an aim of cancer therapy,” he said.

Lambertini, who is also a member of the ESMO Guideline Group on fertility preservation in cancer patients, referred to the 2020 ESMO guidelines, which list the gonadotoxicity of a substance depending on the treatment regimen and the patient’s age.

Isabelle Demeestere, MD, PhD, director of the research lab for human reproduction at the Erasmus Hospital of the Free University of Brussels in Brussels, Belgium, pointed out the limitations of general guidelines. “Therapies change over time, and a classification must be updated regularly.”

Knowledge gaps related to well-known therapies and many novel options persist. “For many FDA-approved medications, there are either no fertility data or only preclinical data available,” she added.
 

Chemotherapies and Immunotherapies

Chemotherapies with alkylating or platinum-containing substances are known for their effects on oocytes, follicle maturation, and spermatogenesis, said Demeestere.

Chemotherapy is gonadotoxic and leads to a temporary decrease in sperm quality or temporary azoospermia in men.

These effects, however, can lead to permanent azoospermia and endocrine disorders, depending on the dose, duration, or combination with radiation, said Demeestere.

Cryopreservation of sperm should always be performed before starting treatment. For high-risk patients who are prepubertal, samples of testicular tissue are taken.

In women, chemotherapy affects primordial follicles and follicle maturation through DNA damage. This process results in severe or temporary amenorrhea, a temporary or permanent decrease in egg reserve, and ultimately premature egg insufficiency.

Novel immunotherapies also influence fertility, presumably through interactions of the immune system with the reproductive organs. But insufficient data are available, according to Lambertini, who emphasized that “these data are urgently needed, especially for young patients with cancer.”

In a mouse model, immune checkpoint inhibitors affected ovarian function, and the inflammatory reaction in humans can affect fertility. No long-term data are available for women yet, however, explained Demeestere. The effects of other therapeutics such as PARP, CDK4/6, or tyrosine kinase inhibitors, as well as monoclonal antibodies like trastuzumab, are only seen sporadically.

In the PENELOPE-B phase 3 study, the CDK4/6 inhibitor palbociclib did not affect ovarian function, even though the cyclin-dependent kinases play an important role in mitotic arrest, said Demeestere.
 

Adjusting the Regimen

In a PET-guided approach, Demeestere’s research team investigated the effects of dose reduction or adjustment of the treatment regimen of procarbazine and cyclophosphamide on the fertility of patients younger than 45 years with advanced Hodgkin lymphoma.

By regularly controlling tumor growth with PET, the treatment could be adjusted so that the effect on egg reserve or spermatogenesis was significantly reduced and loss of fertility could be prevented.

During the 5-year follow-up period, the ovarian function of participating women was assessed by the serum concentration of follicle-stimulating hormone (FSH), estradiol, and anti-Müllerian hormone (AMH) to evaluate egg reserve. In men, testicular function was assessed at the beginning of the study. At the end of treatment, sperm analysis and FSH and testosterone levels were checked.

Demeestere and colleagues demonstrated that dose reduction or altering the treatment regimen for patients who responded early to treatment (determined by PET-guided monitoring) reduced the risk for gonadotoxicity from 46% to 14.5%. That is, the risk was reduced by more than half.

FSH and AMH correlated with the patient’s age and the dose of the alkylating agent. In men, sperm parameters recovered after dose or agent adjustment compared with the unchanged treatment regimen.

Newer results from the PHERGain study in women with early human epidermal growth factor receptor 2–positive breast cancer also provided hope, according to Demeestere. Under PET-guided control, chemotherapy could be reduced.
 

More Data Needed

The new treatment options pose a challenge to preserving fertility during cancer treatment, said Demeestere.

For new targeted therapies, uniform recommendations cannot be issued because of the lack of data and varying treatment durations. Still, the new therapies are safer than chemotherapy.

The need to collect data on fertility and long-term effects in cancer survivors in clinical studies is also reflected in the literature, according to Demeestere. “There are more review articles on this topic than clinical studies.”
 

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

Thanks to the continuously improving treatment options for cancer, the number of cancer survivors is increasing, and a large proportion of survivors is confronted with the long-term effects of cancer treatment. Especially for young patients, the question of the impact of therapy on fertility arises.

Dose adjustment or modification of the treatment regimen can achieve a lot. But experts at the congress of the European Society for Medical Oncology (ESMO) 2024 noted that knowledge about newer treatment options like immunotherapies is still insufficient.
 

Therapy Selection

The question of preserving fertility must be considered when deciding on the appropriate treatment, said Matteo Lambertini, MD, PhD, medical oncology consultant at the University of Genoa in Genoa, Italy. A patient’s age, the type of therapy, and the dose are crucial in determining whether or how much fertility is affected. “Preserving fertility is also an aim of cancer therapy,” he said.

Lambertini, who is also a member of the ESMO Guideline Group on fertility preservation in cancer patients, referred to the 2020 ESMO guidelines, which list the gonadotoxicity of a substance depending on the treatment regimen and the patient’s age.

Isabelle Demeestere, MD, PhD, director of the research lab for human reproduction at the Erasmus Hospital of the Free University of Brussels in Brussels, Belgium, pointed out the limitations of general guidelines. “Therapies change over time, and a classification must be updated regularly.”

Knowledge gaps related to well-known therapies and many novel options persist. “For many FDA-approved medications, there are either no fertility data or only preclinical data available,” she added.
 

Chemotherapies and Immunotherapies

Chemotherapies with alkylating or platinum-containing substances are known for their effects on oocytes, follicle maturation, and spermatogenesis, said Demeestere.

Chemotherapy is gonadotoxic and leads to a temporary decrease in sperm quality or temporary azoospermia in men.

These effects, however, can lead to permanent azoospermia and endocrine disorders, depending on the dose, duration, or combination with radiation, said Demeestere.

Cryopreservation of sperm should always be performed before starting treatment. For high-risk patients who are prepubertal, samples of testicular tissue are taken.

In women, chemotherapy affects primordial follicles and follicle maturation through DNA damage. This process results in severe or temporary amenorrhea, a temporary or permanent decrease in egg reserve, and ultimately premature egg insufficiency.

Novel immunotherapies also influence fertility, presumably through interactions of the immune system with the reproductive organs. But insufficient data are available, according to Lambertini, who emphasized that “these data are urgently needed, especially for young patients with cancer.”

In a mouse model, immune checkpoint inhibitors affected ovarian function, and the inflammatory reaction in humans can affect fertility. No long-term data are available for women yet, however, explained Demeestere. The effects of other therapeutics such as PARP, CDK4/6, or tyrosine kinase inhibitors, as well as monoclonal antibodies like trastuzumab, are only seen sporadically.

In the PENELOPE-B phase 3 study, the CDK4/6 inhibitor palbociclib did not affect ovarian function, even though the cyclin-dependent kinases play an important role in mitotic arrest, said Demeestere.
 

Adjusting the Regimen

In a PET-guided approach, Demeestere’s research team investigated the effects of dose reduction or adjustment of the treatment regimen of procarbazine and cyclophosphamide on the fertility of patients younger than 45 years with advanced Hodgkin lymphoma.

By regularly controlling tumor growth with PET, the treatment could be adjusted so that the effect on egg reserve or spermatogenesis was significantly reduced and loss of fertility could be prevented.

During the 5-year follow-up period, the ovarian function of participating women was assessed by the serum concentration of follicle-stimulating hormone (FSH), estradiol, and anti-Müllerian hormone (AMH) to evaluate egg reserve. In men, testicular function was assessed at the beginning of the study. At the end of treatment, sperm analysis and FSH and testosterone levels were checked.

Demeestere and colleagues demonstrated that dose reduction or altering the treatment regimen for patients who responded early to treatment (determined by PET-guided monitoring) reduced the risk for gonadotoxicity from 46% to 14.5%. That is, the risk was reduced by more than half.

FSH and AMH correlated with the patient’s age and the dose of the alkylating agent. In men, sperm parameters recovered after dose or agent adjustment compared with the unchanged treatment regimen.

Newer results from the PHERGain study in women with early human epidermal growth factor receptor 2–positive breast cancer also provided hope, according to Demeestere. Under PET-guided control, chemotherapy could be reduced.
 

More Data Needed

The new treatment options pose a challenge to preserving fertility during cancer treatment, said Demeestere.

For new targeted therapies, uniform recommendations cannot be issued because of the lack of data and varying treatment durations. Still, the new therapies are safer than chemotherapy.

The need to collect data on fertility and long-term effects in cancer survivors in clinical studies is also reflected in the literature, according to Demeestere. “There are more review articles on this topic than clinical studies.”
 

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

Thanks to the continuously improving treatment options for cancer, the number of cancer survivors is increasing, and a large proportion of survivors is confronted with the long-term effects of cancer treatment. Especially for young patients, the question of the impact of therapy on fertility arises.

Dose adjustment or modification of the treatment regimen can achieve a lot. But experts at the congress of the European Society for Medical Oncology (ESMO) 2024 noted that knowledge about newer treatment options like immunotherapies is still insufficient.
 

Therapy Selection

The question of preserving fertility must be considered when deciding on the appropriate treatment, said Matteo Lambertini, MD, PhD, medical oncology consultant at the University of Genoa in Genoa, Italy. A patient’s age, the type of therapy, and the dose are crucial in determining whether or how much fertility is affected. “Preserving fertility is also an aim of cancer therapy,” he said.

Lambertini, who is also a member of the ESMO Guideline Group on fertility preservation in cancer patients, referred to the 2020 ESMO guidelines, which list the gonadotoxicity of a substance depending on the treatment regimen and the patient’s age.

Isabelle Demeestere, MD, PhD, director of the research lab for human reproduction at the Erasmus Hospital of the Free University of Brussels in Brussels, Belgium, pointed out the limitations of general guidelines. “Therapies change over time, and a classification must be updated regularly.”

Knowledge gaps related to well-known therapies and many novel options persist. “For many FDA-approved medications, there are either no fertility data or only preclinical data available,” she added.
 

Chemotherapies and Immunotherapies

Chemotherapies with alkylating or platinum-containing substances are known for their effects on oocytes, follicle maturation, and spermatogenesis, said Demeestere.

Chemotherapy is gonadotoxic and leads to a temporary decrease in sperm quality or temporary azoospermia in men.

These effects, however, can lead to permanent azoospermia and endocrine disorders, depending on the dose, duration, or combination with radiation, said Demeestere.

Cryopreservation of sperm should always be performed before starting treatment. For high-risk patients who are prepubertal, samples of testicular tissue are taken.

In women, chemotherapy affects primordial follicles and follicle maturation through DNA damage. This process results in severe or temporary amenorrhea, a temporary or permanent decrease in egg reserve, and ultimately premature egg insufficiency.

Novel immunotherapies also influence fertility, presumably through interactions of the immune system with the reproductive organs. But insufficient data are available, according to Lambertini, who emphasized that “these data are urgently needed, especially for young patients with cancer.”

In a mouse model, immune checkpoint inhibitors affected ovarian function, and the inflammatory reaction in humans can affect fertility. No long-term data are available for women yet, however, explained Demeestere. The effects of other therapeutics such as PARP, CDK4/6, or tyrosine kinase inhibitors, as well as monoclonal antibodies like trastuzumab, are only seen sporadically.

In the PENELOPE-B phase 3 study, the CDK4/6 inhibitor palbociclib did not affect ovarian function, even though the cyclin-dependent kinases play an important role in mitotic arrest, said Demeestere.
 

Adjusting the Regimen

In a PET-guided approach, Demeestere’s research team investigated the effects of dose reduction or adjustment of the treatment regimen of procarbazine and cyclophosphamide on the fertility of patients younger than 45 years with advanced Hodgkin lymphoma.

By regularly controlling tumor growth with PET, the treatment could be adjusted so that the effect on egg reserve or spermatogenesis was significantly reduced and loss of fertility could be prevented.

During the 5-year follow-up period, the ovarian function of participating women was assessed by the serum concentration of follicle-stimulating hormone (FSH), estradiol, and anti-Müllerian hormone (AMH) to evaluate egg reserve. In men, testicular function was assessed at the beginning of the study. At the end of treatment, sperm analysis and FSH and testosterone levels were checked.

Demeestere and colleagues demonstrated that dose reduction or altering the treatment regimen for patients who responded early to treatment (determined by PET-guided monitoring) reduced the risk for gonadotoxicity from 46% to 14.5%. That is, the risk was reduced by more than half.

FSH and AMH correlated with the patient’s age and the dose of the alkylating agent. In men, sperm parameters recovered after dose or agent adjustment compared with the unchanged treatment regimen.

Newer results from the PHERGain study in women with early human epidermal growth factor receptor 2–positive breast cancer also provided hope, according to Demeestere. Under PET-guided control, chemotherapy could be reduced.
 

More Data Needed

The new treatment options pose a challenge to preserving fertility during cancer treatment, said Demeestere.

For new targeted therapies, uniform recommendations cannot be issued because of the lack of data and varying treatment durations. Still, the new therapies are safer than chemotherapy.

The need to collect data on fertility and long-term effects in cancer survivors in clinical studies is also reflected in the literature, according to Demeestere. “There are more review articles on this topic than clinical studies.”
 

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

The peer-review process, which is used by scientific journals to validate legitimate research, is now under legal scrutiny. The US District Court for the Southern District of New York will soon rule on whether scientific publishers have compromised this system for profit. In mid-September, University of California, Los Angeles neuroscientist Lucina Uddin filed a class action lawsuit against six leading academic publishers — Elsevier, Wolters Kluwer, Wiley, Sage Publications, Taylor & Francis, and Springer Nature — accusing them of violating antitrust laws and obstructing academic research.

The lawsuit targets several long-standing practices in scientific publishing, including the lack of compensation for peer reviewers, restrictions that require submitting to only one journal at a time, and bans on sharing manuscripts under review. Uddin’s complaint argues that these practices contribute to inefficiencies in the review process, thus delaying the publication of critical discoveries, which could hinder research, clinical advancements, and the development of new medical treatments.

The suit also noted that these publishers generated $10 billion in revenue in 2023 in peer-reviewed journals. However, the complaint seemingly overlooks the widespread practice of preprint repositories, where many manuscripts are shared while awaiting peer review.
 

Flawed Reviews

A growing number of studies have highlighted subpar or unethical behaviors among reviewers, who are supposed to adhere to the highest standards of methodological rigor, both in conducting research and reviewing work for journals. One recent study published in Scientometrics in August examined 263 reviews from 37 journals across various disciplines and found alarming patterns of duplication. Many of the reviews contained identical or highly similar language. Some reviewers were found to be suggesting that the authors expand their bibliographies to include the reviewers’ own work, thus inflating their citation counts.

As María Ángeles Oviedo-García from the University of Seville in Spain, pointed out: “The analysis of 263 review reports shows a pattern of vague, repetitive statements — often identical or very similar — along with coercive citations, ultimately resulting in misleading reviews.”

Experts in research integrity and ethics argue that while issues persist, the integrity of scientific research is improving. Increasing research and public disclosure reflect a heightened awareness of problems long overlooked.

“There is indeed a problem with research reliability, but it’s not as widespread or severe as some portray,” said Daniele Fanelli, a metascientist at the London School of Economics and Political Science in England. Speaking to this news organization, Fanelli, who has been studying scientific misconduct for about 20 years, noted that while his early work left him disillusioned, further research has replaced his cynicism with what he describes as healthy skepticism and a more optimistic outlook. Fanelli also collaborates with the Luxembourg Agency for Research Integrity and the Advisory Committee on Research Ethics and Bioethics at the Italian National Research Council (CNR), where he helped develop the first research integrity guidelines.
 

Lack of Awareness

A recurring challenge is the difficulty in distinguishing between honest mistakes and intentional misconduct. “This is why greater investment in education is essential,” said Daniel Pizzolato, European Network of Research Ethics Committees, Bonn, Germany, and the Centre for Biomedical Ethics and Law, KU Leuven in Belgium.

While Pizzolato acknowledged that institutions such as the CNR in Italy provide a positive example, awareness of research integrity is generally still lacking across much of Europe, and there are few offices dedicated to promoting research integrity. However, he pointed to promising developments in other countries. “In France and Denmark, researchers are required to be familiar with integrity norms because codes of conduct have legal standing. Some major international funding bodies like the European Molecular Biology Organization are making participation in research integrity courses a condition for receiving grants.”

Pizzolato remains optimistic. “There is a growing willingness to move past this impasse,” he said.

A recent study published in The Journal of Clinical Epidemiology reveals troubling gaps in how retracted biomedical articles are flagged and cited. Led by Caitlin Bakkera, Department of Epidemiology, Maastricht University, Maastricht, the Netherlands, the research sought to determine whether articles retracted because of errors or fraud were properly flagged across various databases.

The results were concerning: Less than 5% of retracted articles had consistent retraction notices across all databases that hosted them, and less than 50% of citations referenced the retraction. None of the 414 retraction notices analyzed met best-practice guidelines for completeness. Bakkera and colleagues warned that these shortcomings threaten the integrity of public health research.
 

Fanelli’s Perspective

Despite the concerns, Fanelli remains calm. “Science is based on debate and a perspective called organized skepticism, which helps reveal the truth,” he explained. “While there is often excessive skepticism today, the overall quality of clinical trials is improving.

“It’s important to remember that reliable results take time and shouldn’t depend on the outcome of a single study. It’s essential to consider the broader context, the history of the research field, and potential conflicts of interest, both financial and otherwise. Biomedical research requires constant updates,” he concluded.

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

The peer-review process, which is used by scientific journals to validate legitimate research, is now under legal scrutiny. The US District Court for the Southern District of New York will soon rule on whether scientific publishers have compromised this system for profit. In mid-September, University of California, Los Angeles neuroscientist Lucina Uddin filed a class action lawsuit against six leading academic publishers — Elsevier, Wolters Kluwer, Wiley, Sage Publications, Taylor & Francis, and Springer Nature — accusing them of violating antitrust laws and obstructing academic research.

The lawsuit targets several long-standing practices in scientific publishing, including the lack of compensation for peer reviewers, restrictions that require submitting to only one journal at a time, and bans on sharing manuscripts under review. Uddin’s complaint argues that these practices contribute to inefficiencies in the review process, thus delaying the publication of critical discoveries, which could hinder research, clinical advancements, and the development of new medical treatments.

The suit also noted that these publishers generated $10 billion in revenue in 2023 in peer-reviewed journals. However, the complaint seemingly overlooks the widespread practice of preprint repositories, where many manuscripts are shared while awaiting peer review.
 

Flawed Reviews

A growing number of studies have highlighted subpar or unethical behaviors among reviewers, who are supposed to adhere to the highest standards of methodological rigor, both in conducting research and reviewing work for journals. One recent study published in Scientometrics in August examined 263 reviews from 37 journals across various disciplines and found alarming patterns of duplication. Many of the reviews contained identical or highly similar language. Some reviewers were found to be suggesting that the authors expand their bibliographies to include the reviewers’ own work, thus inflating their citation counts.

As María Ángeles Oviedo-García from the University of Seville in Spain, pointed out: “The analysis of 263 review reports shows a pattern of vague, repetitive statements — often identical or very similar — along with coercive citations, ultimately resulting in misleading reviews.”

Experts in research integrity and ethics argue that while issues persist, the integrity of scientific research is improving. Increasing research and public disclosure reflect a heightened awareness of problems long overlooked.

“There is indeed a problem with research reliability, but it’s not as widespread or severe as some portray,” said Daniele Fanelli, a metascientist at the London School of Economics and Political Science in England. Speaking to this news organization, Fanelli, who has been studying scientific misconduct for about 20 years, noted that while his early work left him disillusioned, further research has replaced his cynicism with what he describes as healthy skepticism and a more optimistic outlook. Fanelli also collaborates with the Luxembourg Agency for Research Integrity and the Advisory Committee on Research Ethics and Bioethics at the Italian National Research Council (CNR), where he helped develop the first research integrity guidelines.
 

Lack of Awareness

A recurring challenge is the difficulty in distinguishing between honest mistakes and intentional misconduct. “This is why greater investment in education is essential,” said Daniel Pizzolato, European Network of Research Ethics Committees, Bonn, Germany, and the Centre for Biomedical Ethics and Law, KU Leuven in Belgium.

While Pizzolato acknowledged that institutions such as the CNR in Italy provide a positive example, awareness of research integrity is generally still lacking across much of Europe, and there are few offices dedicated to promoting research integrity. However, he pointed to promising developments in other countries. “In France and Denmark, researchers are required to be familiar with integrity norms because codes of conduct have legal standing. Some major international funding bodies like the European Molecular Biology Organization are making participation in research integrity courses a condition for receiving grants.”

Pizzolato remains optimistic. “There is a growing willingness to move past this impasse,” he said.

A recent study published in The Journal of Clinical Epidemiology reveals troubling gaps in how retracted biomedical articles are flagged and cited. Led by Caitlin Bakkera, Department of Epidemiology, Maastricht University, Maastricht, the Netherlands, the research sought to determine whether articles retracted because of errors or fraud were properly flagged across various databases.

The results were concerning: Less than 5% of retracted articles had consistent retraction notices across all databases that hosted them, and less than 50% of citations referenced the retraction. None of the 414 retraction notices analyzed met best-practice guidelines for completeness. Bakkera and colleagues warned that these shortcomings threaten the integrity of public health research.
 

Fanelli’s Perspective

Despite the concerns, Fanelli remains calm. “Science is based on debate and a perspective called organized skepticism, which helps reveal the truth,” he explained. “While there is often excessive skepticism today, the overall quality of clinical trials is improving.

“It’s important to remember that reliable results take time and shouldn’t depend on the outcome of a single study. It’s essential to consider the broader context, the history of the research field, and potential conflicts of interest, both financial and otherwise. Biomedical research requires constant updates,” he concluded.

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

The peer-review process, which is used by scientific journals to validate legitimate research, is now under legal scrutiny. The US District Court for the Southern District of New York will soon rule on whether scientific publishers have compromised this system for profit. In mid-September, University of California, Los Angeles neuroscientist Lucina Uddin filed a class action lawsuit against six leading academic publishers — Elsevier, Wolters Kluwer, Wiley, Sage Publications, Taylor & Francis, and Springer Nature — accusing them of violating antitrust laws and obstructing academic research.

The lawsuit targets several long-standing practices in scientific publishing, including the lack of compensation for peer reviewers, restrictions that require submitting to only one journal at a time, and bans on sharing manuscripts under review. Uddin’s complaint argues that these practices contribute to inefficiencies in the review process, thus delaying the publication of critical discoveries, which could hinder research, clinical advancements, and the development of new medical treatments.

The suit also noted that these publishers generated $10 billion in revenue in 2023 in peer-reviewed journals. However, the complaint seemingly overlooks the widespread practice of preprint repositories, where many manuscripts are shared while awaiting peer review.
 

Flawed Reviews

A growing number of studies have highlighted subpar or unethical behaviors among reviewers, who are supposed to adhere to the highest standards of methodological rigor, both in conducting research and reviewing work for journals. One recent study published in Scientometrics in August examined 263 reviews from 37 journals across various disciplines and found alarming patterns of duplication. Many of the reviews contained identical or highly similar language. Some reviewers were found to be suggesting that the authors expand their bibliographies to include the reviewers’ own work, thus inflating their citation counts.

As María Ángeles Oviedo-García from the University of Seville in Spain, pointed out: “The analysis of 263 review reports shows a pattern of vague, repetitive statements — often identical or very similar — along with coercive citations, ultimately resulting in misleading reviews.”

Experts in research integrity and ethics argue that while issues persist, the integrity of scientific research is improving. Increasing research and public disclosure reflect a heightened awareness of problems long overlooked.

“There is indeed a problem with research reliability, but it’s not as widespread or severe as some portray,” said Daniele Fanelli, a metascientist at the London School of Economics and Political Science in England. Speaking to this news organization, Fanelli, who has been studying scientific misconduct for about 20 years, noted that while his early work left him disillusioned, further research has replaced his cynicism with what he describes as healthy skepticism and a more optimistic outlook. Fanelli also collaborates with the Luxembourg Agency for Research Integrity and the Advisory Committee on Research Ethics and Bioethics at the Italian National Research Council (CNR), where he helped develop the first research integrity guidelines.
 

Lack of Awareness

A recurring challenge is the difficulty in distinguishing between honest mistakes and intentional misconduct. “This is why greater investment in education is essential,” said Daniel Pizzolato, European Network of Research Ethics Committees, Bonn, Germany, and the Centre for Biomedical Ethics and Law, KU Leuven in Belgium.

While Pizzolato acknowledged that institutions such as the CNR in Italy provide a positive example, awareness of research integrity is generally still lacking across much of Europe, and there are few offices dedicated to promoting research integrity. However, he pointed to promising developments in other countries. “In France and Denmark, researchers are required to be familiar with integrity norms because codes of conduct have legal standing. Some major international funding bodies like the European Molecular Biology Organization are making participation in research integrity courses a condition for receiving grants.”

Pizzolato remains optimistic. “There is a growing willingness to move past this impasse,” he said.

A recent study published in The Journal of Clinical Epidemiology reveals troubling gaps in how retracted biomedical articles are flagged and cited. Led by Caitlin Bakkera, Department of Epidemiology, Maastricht University, Maastricht, the Netherlands, the research sought to determine whether articles retracted because of errors or fraud were properly flagged across various databases.

The results were concerning: Less than 5% of retracted articles had consistent retraction notices across all databases that hosted them, and less than 50% of citations referenced the retraction. None of the 414 retraction notices analyzed met best-practice guidelines for completeness. Bakkera and colleagues warned that these shortcomings threaten the integrity of public health research.
 

Fanelli’s Perspective

Despite the concerns, Fanelli remains calm. “Science is based on debate and a perspective called organized skepticism, which helps reveal the truth,” he explained. “While there is often excessive skepticism today, the overall quality of clinical trials is improving.

“It’s important to remember that reliable results take time and shouldn’t depend on the outcome of a single study. It’s essential to consider the broader context, the history of the research field, and potential conflicts of interest, both financial and otherwise. Biomedical research requires constant updates,” he concluded.

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

TOPLINE:

Gestational supplementation of 1000 IU/d cholecalciferol (vitamin D3) from early pregnancy until delivery increases the bone mineral content, bone mineral density (BMD), and bone mineral apparent density in children at age 6-7 years.

METHODOLOGY:

• The double-blinded, placebo-controlled MAVIDOS trial of gestational vitamin D supplementation previously showed increased BMD at age 4 years (but no difference at birth), and it is unclear how the effect may persist or change over time.
• In the original trial, researchers randomized 1134 pregnant women with singleton pregnancy from three UK hospitals from 2008 to 2014, and the 723 children born to mothers recruited in Southampton were invited to continue in offspring follow-up.
• Mothers were randomly assigned to receive either 1000-IU/d vitamin D or placebo from 14-17 weeks’ gestation until delivery; women in the placebo arm could take up to 400-IU/d vitamin D.
• In this post hoc analysis, among 454 children who were followed up at age 6-7 years, 447 had a usable whole body and lumbar spine dual-energy x-ray absorptiometry scan (placebo group: n = 216; 48% boys; 98% White mothers and vitamin D group: n = 231; 56% boys; 96% White mothers).
• Offspring follow-up measures at birth and 4 and 6-7 years were bone area, bone mineral content, BMD, and bone mineral apparent density, derived from a dual-energy x-ray absorptiometry scan of whole body less head (WBLH), as well as fat and lean mass.

TAKEAWAY:

• The effect of gestational vitamin D supplementation on bone outcomes in children was similar at ages 4 and 6-7 years.
• At age 6-7 years, gestational vitamin D supplementation resulted in higher WBLH bone mineral content (0.15 SD; 95% CI, 0.04-0.26) and BMD (0.18 SD; 95% CI, 0.06-0.31) than placebo.
• The WBLH bone mineral apparent density (0.18 SD; 95% CI, 0.04-0.32) was also higher in the vitamin D group.
• The lean mass was greater in the vitamin D group (0.09 SD; 95% CI, 0.00-0.17) than in the placebo group.

IN PRACTICE:

“These findings suggest that pregnancy vitamin D supplementation may be an important population health strategy to improve bone health,” the authors wrote.

SOURCE:

This study was led by Rebecca J. Moon, PhD, MRC Lifecourse Epidemiology Centre, University of Southampton, Southampton General Hospital, England. It was published online in The American Journal of Clinical Nutrition.

LIMITATIONS: 

Only individuals with baseline vitamin D levels of 25-100 nmol/L were eligible, excluding those with severe deficiency who might have benefited the most from supplementation. The participants were mostly White and well-educated, commonly overweight, which may have limited generalizability to other populations. Only 47% of the original cohort participated in the follow-up phase. Differences in maternal age, smoking status, and education between participants who remained in the study and those who did not may have introduced bias and affected generalizability.

DISCLOSURES:

The study was supported by Versus Arthritis UK, Medical Research Council, Bupa Foundation, and National Institute for Health and Care Research, Southampton Biomedical Research Centre, and other sources. Some authors disclosed receiving travel reimbursement, speaker or lecture fees, honoraria, research funding, or personal or consultancy fees from Alliance for Better Bone Health and various pharmaceutical, biotechnology, medical device, healthcare, and food and nutrition companies outside the submitted work.

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:

Gestational supplementation of 1000 IU/d cholecalciferol (vitamin D3) from early pregnancy until delivery increases the bone mineral content, bone mineral density (BMD), and bone mineral apparent density in children at age 6-7 years.

METHODOLOGY:

• The double-blinded, placebo-controlled MAVIDOS trial of gestational vitamin D supplementation previously showed increased BMD at age 4 years (but no difference at birth), and it is unclear how the effect may persist or change over time.
• In the original trial, researchers randomized 1134 pregnant women with singleton pregnancy from three UK hospitals from 2008 to 2014, and the 723 children born to mothers recruited in Southampton were invited to continue in offspring follow-up.
• Mothers were randomly assigned to receive either 1000-IU/d vitamin D or placebo from 14-17 weeks’ gestation until delivery; women in the placebo arm could take up to 400-IU/d vitamin D.
• In this post hoc analysis, among 454 children who were followed up at age 6-7 years, 447 had a usable whole body and lumbar spine dual-energy x-ray absorptiometry scan (placebo group: n = 216; 48% boys; 98% White mothers and vitamin D group: n = 231; 56% boys; 96% White mothers).
• Offspring follow-up measures at birth and 4 and 6-7 years were bone area, bone mineral content, BMD, and bone mineral apparent density, derived from a dual-energy x-ray absorptiometry scan of whole body less head (WBLH), as well as fat and lean mass.

TAKEAWAY:

• The effect of gestational vitamin D supplementation on bone outcomes in children was similar at ages 4 and 6-7 years.
• At age 6-7 years, gestational vitamin D supplementation resulted in higher WBLH bone mineral content (0.15 SD; 95% CI, 0.04-0.26) and BMD (0.18 SD; 95% CI, 0.06-0.31) than placebo.
• The WBLH bone mineral apparent density (0.18 SD; 95% CI, 0.04-0.32) was also higher in the vitamin D group.
• The lean mass was greater in the vitamin D group (0.09 SD; 95% CI, 0.00-0.17) than in the placebo group.

IN PRACTICE:

“These findings suggest that pregnancy vitamin D supplementation may be an important population health strategy to improve bone health,” the authors wrote.

SOURCE:

This study was led by Rebecca J. Moon, PhD, MRC Lifecourse Epidemiology Centre, University of Southampton, Southampton General Hospital, England. It was published online in The American Journal of Clinical Nutrition.

LIMITATIONS: 

Only individuals with baseline vitamin D levels of 25-100 nmol/L were eligible, excluding those with severe deficiency who might have benefited the most from supplementation. The participants were mostly White and well-educated, commonly overweight, which may have limited generalizability to other populations. Only 47% of the original cohort participated in the follow-up phase. Differences in maternal age, smoking status, and education between participants who remained in the study and those who did not may have introduced bias and affected generalizability.

DISCLOSURES:

The study was supported by Versus Arthritis UK, Medical Research Council, Bupa Foundation, and National Institute for Health and Care Research, Southampton Biomedical Research Centre, and other sources. Some authors disclosed receiving travel reimbursement, speaker or lecture fees, honoraria, research funding, or personal or consultancy fees from Alliance for Better Bone Health and various pharmaceutical, biotechnology, medical device, healthcare, and food and nutrition companies outside the submitted work.

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:

Gestational supplementation of 1000 IU/d cholecalciferol (vitamin D3) from early pregnancy until delivery increases the bone mineral content, bone mineral density (BMD), and bone mineral apparent density in children at age 6-7 years.

METHODOLOGY:

• The double-blinded, placebo-controlled MAVIDOS trial of gestational vitamin D supplementation previously showed increased BMD at age 4 years (but no difference at birth), and it is unclear how the effect may persist or change over time.
• In the original trial, researchers randomized 1134 pregnant women with singleton pregnancy from three UK hospitals from 2008 to 2014, and the 723 children born to mothers recruited in Southampton were invited to continue in offspring follow-up.
• Mothers were randomly assigned to receive either 1000-IU/d vitamin D or placebo from 14-17 weeks’ gestation until delivery; women in the placebo arm could take up to 400-IU/d vitamin D.
• In this post hoc analysis, among 454 children who were followed up at age 6-7 years, 447 had a usable whole body and lumbar spine dual-energy x-ray absorptiometry scan (placebo group: n = 216; 48% boys; 98% White mothers and vitamin D group: n = 231; 56% boys; 96% White mothers).
• Offspring follow-up measures at birth and 4 and 6-7 years were bone area, bone mineral content, BMD, and bone mineral apparent density, derived from a dual-energy x-ray absorptiometry scan of whole body less head (WBLH), as well as fat and lean mass.

TAKEAWAY:

• The effect of gestational vitamin D supplementation on bone outcomes in children was similar at ages 4 and 6-7 years.
• At age 6-7 years, gestational vitamin D supplementation resulted in higher WBLH bone mineral content (0.15 SD; 95% CI, 0.04-0.26) and BMD (0.18 SD; 95% CI, 0.06-0.31) than placebo.
• The WBLH bone mineral apparent density (0.18 SD; 95% CI, 0.04-0.32) was also higher in the vitamin D group.
• The lean mass was greater in the vitamin D group (0.09 SD; 95% CI, 0.00-0.17) than in the placebo group.

IN PRACTICE:

“These findings suggest that pregnancy vitamin D supplementation may be an important population health strategy to improve bone health,” the authors wrote.

SOURCE:

This study was led by Rebecca J. Moon, PhD, MRC Lifecourse Epidemiology Centre, University of Southampton, Southampton General Hospital, England. It was published online in The American Journal of Clinical Nutrition.

LIMITATIONS: 

Only individuals with baseline vitamin D levels of 25-100 nmol/L were eligible, excluding those with severe deficiency who might have benefited the most from supplementation. The participants were mostly White and well-educated, commonly overweight, which may have limited generalizability to other populations. Only 47% of the original cohort participated in the follow-up phase. Differences in maternal age, smoking status, and education between participants who remained in the study and those who did not may have introduced bias and affected generalizability.

DISCLOSURES:

The study was supported by Versus Arthritis UK, Medical Research Council, Bupa Foundation, and National Institute for Health and Care Research, Southampton Biomedical Research Centre, and other sources. Some authors disclosed receiving travel reimbursement, speaker or lecture fees, honoraria, research funding, or personal or consultancy fees from Alliance for Better Bone Health and various pharmaceutical, biotechnology, medical device, healthcare, and food and nutrition companies outside the submitted work.

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.

Breast cancer incidence has been on the rise, particularly among White women under age 50, but breast cancer deaths — for some, but not all, populations — have been steadily decreasing, according to a biennial update from the American Cancer Society (ACS).

The ACS update, which underscores the persistence of racial and ethnic disparities in breast cancer incidence and outcomes, noted an overall 1% annual increase in breast cancer incidence from 2012 to 2021. The additional cases were largely composed of localized-stage and hormone receptor (HR)–positive disease, which generally have better prognoses than more advanced and HR–negative disease.

Deaths from breast cancer, however, declined from 1989 to 2022, with an overall drop of 44%. That percentage drop “translates to almost 518,000 fewer women dying from breast cancer in the United States during this time,” Angela N. Giaquinto and ACS colleagues noted in the report, published in CA: A Cancer Journal for Clinicians.

“This progress is the result of advances in treatment and earlier detection through screening,” the authors wrote, while stressing that “these interventions have not been disseminated equally.”

The ACS also published an educational companion — Breast Cancer Facts & Figures 2024-2025 — that provides additional insights about trends in breast cancer and steps needed to bolster prevention, detection, and treatment advances.
 

Incidence and Mortality

Although the overall annual increase in breast cancer incidence from 2012 to 2021 was 1%, the increase was steeper among women under age 50, at 1.4% annually vs 0.7% among those aged 50 or older.

Asian American/Pacific Islander women had the greatest increases in breast cancer incidence among both age groups, with a 2.7% annual increase for those aged under 50 and a 2.5% increase for those aged 50 or older. This group, however, had the second lowest breast cancer rate in 2000 at 57.4 cases per 100,000 persons, but the highest rate in 2021 at 86.3 cases per 100,000, alongside White women (86.4 cases per 100,000). Black women were not far behind at 81.5 cases per 100,000.

Black women were least likely to be diagnosed with localized-stage breast cancer and most likely to be diagnosed with distant-stage or unstaged cancer, with American Indian/Alaska Native women not far behind.

Despite the rising incidence of breast cancer, death rates from the disease have gone down considerably overall from about 33 deaths per 100,000 women in 1989 to 19 deaths per 100,000 in 2022.

However, not all women have experienced these survival gains equally, Ms. Giaquinto and colleagues noted.

Since 1990, the mortality rate has remained unchanged among American Indian/Alaska Native women. Black women, however, have experienced a 38% higher mortality rate than White women, despite having a 5% lower incidence of breast cancer.

In fact, Black women have the lowest survival of any racial and ethnic group for every breast cancer subtype and stage of disease except localized disease.

Additional key findings from the report:

• In 2024, an estimated 310,720 new invasive breast cancers and 56,500 cases of ductal carcinoma in situ will be diagnosed among women in the United States, and an additional 2790 cases will be diagnosed in men.
• On the mortality front, in 2024, approximately 42,250 women are expected to die of breast cancer; 530 breast cancer deaths are anticipated in men.
• As for the lifetime risk for breast cancer, approximately one in eight women in the United States (13.1%) will be diagnosed with invasive breast cancer; 1 in 43 (2.3%) will die from the disease.
• The 5-year relative survival rate for breast cancer is 91%, but that drops to 86% at 10 years and 81% at 15 years.
• The 5-year relative survival rate is over 99% for breast cancer diagnosed at a localized stage but drops to 87% for regional-stage and 32% for distant-stage disease.
• American Indian/Alaska Native women have a 10% lower breast cancer incidence than White women but 6% higher mortality.

Similar to the ACS report, a recent study published in JAMA Network Open reported rising breast cancer incidence among US women aged 20-49 years of different races in different age groups over the past 2 decades.

The increased incidence of breast cancer in younger women “is an area of concern and an area where we really need to spend more effort trying to understand why,” said lead study author and breast surgeon Adetunji T. Toriola, MD, PhD, MPH, of Washington University in St Louis, Missouri.

Although reproductive and lifestyle factors, such as weight gain, diet, and physical activity, may contribute to the growing breast cancer incidence in younger women — and preliminary findings from Dr. Toriola’s own research suggest that reproductive factors may be a particularly strong driver — environmental factors, including exposure to forever chemicals, may also play a role.

Early-life factors, such as exposure to toxins, remain an underexplored area, Dr. Toriola noted, stressing the importance of teasing out the long-term effects of environmental exposures in puberty and during adolescence.

Overall, the trends observed both in this study and the ACS report highlight the need for enhanced prevention efforts that address racial disparities as well as the rising incidence in young women, said Dr. Toriola, also professor of surgery at the Washington University Institute of Public Health, St Louis.

For now, Dr. Toriola urges women to “engage with mammographic screening as soon as qualified” as per guidelines. Women at average risk should go for screening beginning at age 40, and those with a family history or other risk factors should talk to their physician about earlier screening, he said.

Ms. Giaquinto is employed by the ACS, which receives grants from private and corporate foundations, including foundations associated with companies in the health sector, for research outside of the submitted work. Dr. Toriola reported having no disclosures.

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

Breast cancer incidence has been on the rise, particularly among White women under age 50, but breast cancer deaths — for some, but not all, populations — have been steadily decreasing, according to a biennial update from the American Cancer Society (ACS).

The ACS update, which underscores the persistence of racial and ethnic disparities in breast cancer incidence and outcomes, noted an overall 1% annual increase in breast cancer incidence from 2012 to 2021. The additional cases were largely composed of localized-stage and hormone receptor (HR)–positive disease, which generally have better prognoses than more advanced and HR–negative disease.

Deaths from breast cancer, however, declined from 1989 to 2022, with an overall drop of 44%. That percentage drop “translates to almost 518,000 fewer women dying from breast cancer in the United States during this time,” Angela N. Giaquinto and ACS colleagues noted in the report, published in CA: A Cancer Journal for Clinicians.

“This progress is the result of advances in treatment and earlier detection through screening,” the authors wrote, while stressing that “these interventions have not been disseminated equally.”

The ACS also published an educational companion — Breast Cancer Facts & Figures 2024-2025 — that provides additional insights about trends in breast cancer and steps needed to bolster prevention, detection, and treatment advances.
 

Incidence and Mortality

Although the overall annual increase in breast cancer incidence from 2012 to 2021 was 1%, the increase was steeper among women under age 50, at 1.4% annually vs 0.7% among those aged 50 or older.

Asian American/Pacific Islander women had the greatest increases in breast cancer incidence among both age groups, with a 2.7% annual increase for those aged under 50 and a 2.5% increase for those aged 50 or older. This group, however, had the second lowest breast cancer rate in 2000 at 57.4 cases per 100,000 persons, but the highest rate in 2021 at 86.3 cases per 100,000, alongside White women (86.4 cases per 100,000). Black women were not far behind at 81.5 cases per 100,000.

Black women were least likely to be diagnosed with localized-stage breast cancer and most likely to be diagnosed with distant-stage or unstaged cancer, with American Indian/Alaska Native women not far behind.

Despite the rising incidence of breast cancer, death rates from the disease have gone down considerably overall from about 33 deaths per 100,000 women in 1989 to 19 deaths per 100,000 in 2022.

However, not all women have experienced these survival gains equally, Ms. Giaquinto and colleagues noted.

Since 1990, the mortality rate has remained unchanged among American Indian/Alaska Native women. Black women, however, have experienced a 38% higher mortality rate than White women, despite having a 5% lower incidence of breast cancer.

In fact, Black women have the lowest survival of any racial and ethnic group for every breast cancer subtype and stage of disease except localized disease.

Additional key findings from the report:

• In 2024, an estimated 310,720 new invasive breast cancers and 56,500 cases of ductal carcinoma in situ will be diagnosed among women in the United States, and an additional 2790 cases will be diagnosed in men.
• On the mortality front, in 2024, approximately 42,250 women are expected to die of breast cancer; 530 breast cancer deaths are anticipated in men.
• As for the lifetime risk for breast cancer, approximately one in eight women in the United States (13.1%) will be diagnosed with invasive breast cancer; 1 in 43 (2.3%) will die from the disease.
• The 5-year relative survival rate for breast cancer is 91%, but that drops to 86% at 10 years and 81% at 15 years.
• The 5-year relative survival rate is over 99% for breast cancer diagnosed at a localized stage but drops to 87% for regional-stage and 32% for distant-stage disease.
• American Indian/Alaska Native women have a 10% lower breast cancer incidence than White women but 6% higher mortality.

Similar to the ACS report, a recent study published in JAMA Network Open reported rising breast cancer incidence among US women aged 20-49 years of different races in different age groups over the past 2 decades.

The increased incidence of breast cancer in younger women “is an area of concern and an area where we really need to spend more effort trying to understand why,” said lead study author and breast surgeon Adetunji T. Toriola, MD, PhD, MPH, of Washington University in St Louis, Missouri.

Although reproductive and lifestyle factors, such as weight gain, diet, and physical activity, may contribute to the growing breast cancer incidence in younger women — and preliminary findings from Dr. Toriola’s own research suggest that reproductive factors may be a particularly strong driver — environmental factors, including exposure to forever chemicals, may also play a role.

Early-life factors, such as exposure to toxins, remain an underexplored area, Dr. Toriola noted, stressing the importance of teasing out the long-term effects of environmental exposures in puberty and during adolescence.

Overall, the trends observed both in this study and the ACS report highlight the need for enhanced prevention efforts that address racial disparities as well as the rising incidence in young women, said Dr. Toriola, also professor of surgery at the Washington University Institute of Public Health, St Louis.

For now, Dr. Toriola urges women to “engage with mammographic screening as soon as qualified” as per guidelines. Women at average risk should go for screening beginning at age 40, and those with a family history or other risk factors should talk to their physician about earlier screening, he said.

Ms. Giaquinto is employed by the ACS, which receives grants from private and corporate foundations, including foundations associated with companies in the health sector, for research outside of the submitted work. Dr. Toriola reported having no disclosures.

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

Breast cancer incidence has been on the rise, particularly among White women under age 50, but breast cancer deaths — for some, but not all, populations — have been steadily decreasing, according to a biennial update from the American Cancer Society (ACS).

The ACS update, which underscores the persistence of racial and ethnic disparities in breast cancer incidence and outcomes, noted an overall 1% annual increase in breast cancer incidence from 2012 to 2021. The additional cases were largely composed of localized-stage and hormone receptor (HR)–positive disease, which generally have better prognoses than more advanced and HR–negative disease.

Deaths from breast cancer, however, declined from 1989 to 2022, with an overall drop of 44%. That percentage drop “translates to almost 518,000 fewer women dying from breast cancer in the United States during this time,” Angela N. Giaquinto and ACS colleagues noted in the report, published in CA: A Cancer Journal for Clinicians.

“This progress is the result of advances in treatment and earlier detection through screening,” the authors wrote, while stressing that “these interventions have not been disseminated equally.”

The ACS also published an educational companion — Breast Cancer Facts & Figures 2024-2025 — that provides additional insights about trends in breast cancer and steps needed to bolster prevention, detection, and treatment advances.
 

Incidence and Mortality

Although the overall annual increase in breast cancer incidence from 2012 to 2021 was 1%, the increase was steeper among women under age 50, at 1.4% annually vs 0.7% among those aged 50 or older.

Asian American/Pacific Islander women had the greatest increases in breast cancer incidence among both age groups, with a 2.7% annual increase for those aged under 50 and a 2.5% increase for those aged 50 or older. This group, however, had the second lowest breast cancer rate in 2000 at 57.4 cases per 100,000 persons, but the highest rate in 2021 at 86.3 cases per 100,000, alongside White women (86.4 cases per 100,000). Black women were not far behind at 81.5 cases per 100,000.

Black women were least likely to be diagnosed with localized-stage breast cancer and most likely to be diagnosed with distant-stage or unstaged cancer, with American Indian/Alaska Native women not far behind.

Despite the rising incidence of breast cancer, death rates from the disease have gone down considerably overall from about 33 deaths per 100,000 women in 1989 to 19 deaths per 100,000 in 2022.

However, not all women have experienced these survival gains equally, Ms. Giaquinto and colleagues noted.

Since 1990, the mortality rate has remained unchanged among American Indian/Alaska Native women. Black women, however, have experienced a 38% higher mortality rate than White women, despite having a 5% lower incidence of breast cancer.

In fact, Black women have the lowest survival of any racial and ethnic group for every breast cancer subtype and stage of disease except localized disease.

Additional key findings from the report:

• In 2024, an estimated 310,720 new invasive breast cancers and 56,500 cases of ductal carcinoma in situ will be diagnosed among women in the United States, and an additional 2790 cases will be diagnosed in men.
• On the mortality front, in 2024, approximately 42,250 women are expected to die of breast cancer; 530 breast cancer deaths are anticipated in men.
• As for the lifetime risk for breast cancer, approximately one in eight women in the United States (13.1%) will be diagnosed with invasive breast cancer; 1 in 43 (2.3%) will die from the disease.
• The 5-year relative survival rate for breast cancer is 91%, but that drops to 86% at 10 years and 81% at 15 years.
• The 5-year relative survival rate is over 99% for breast cancer diagnosed at a localized stage but drops to 87% for regional-stage and 32% for distant-stage disease.
• American Indian/Alaska Native women have a 10% lower breast cancer incidence than White women but 6% higher mortality.

Similar to the ACS report, a recent study published in JAMA Network Open reported rising breast cancer incidence among US women aged 20-49 years of different races in different age groups over the past 2 decades.

The increased incidence of breast cancer in younger women “is an area of concern and an area where we really need to spend more effort trying to understand why,” said lead study author and breast surgeon Adetunji T. Toriola, MD, PhD, MPH, of Washington University in St Louis, Missouri.

Although reproductive and lifestyle factors, such as weight gain, diet, and physical activity, may contribute to the growing breast cancer incidence in younger women — and preliminary findings from Dr. Toriola’s own research suggest that reproductive factors may be a particularly strong driver — environmental factors, including exposure to forever chemicals, may also play a role.

Early-life factors, such as exposure to toxins, remain an underexplored area, Dr. Toriola noted, stressing the importance of teasing out the long-term effects of environmental exposures in puberty and during adolescence.

Overall, the trends observed both in this study and the ACS report highlight the need for enhanced prevention efforts that address racial disparities as well as the rising incidence in young women, said Dr. Toriola, also professor of surgery at the Washington University Institute of Public Health, St Louis.

For now, Dr. Toriola urges women to “engage with mammographic screening as soon as qualified” as per guidelines. Women at average risk should go for screening beginning at age 40, and those with a family history or other risk factors should talk to their physician about earlier screening, he said.

Ms. Giaquinto is employed by the ACS, which receives grants from private and corporate foundations, including foundations associated with companies in the health sector, for research outside of the submitted work. Dr. Toriola reported having no disclosures.

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

Summary:

In this segment, the speaker discusses how AI is revolutionizing the drug repurposing process. Previously, drug repurposing was limited by manual research on individual diseases and drugs. With AI, scientists can now analyze a vast array of drugs and diseases simultaneously, generating a ranking system based on the likelihood of success. The Center for Cytokine Storm Treatment and Laboratory, along with the platform Every Cure, uses AI to score 3000 drugs against 18,000 diseases. This platform dramatically reduces the time and resources required for drug repurposing, enabling predictions that can be tested in a fraction of the time.
 

Key Takeaways:

AI is accelerating the drug repurposing process, offering faster and more comprehensive analysis of possible drug-disease matches.

The AI-based platform assigns a likelihood score to each potential match, streamlining the process for testing and validation.

The ability to analyze global biomedical knowledge in 24 hours is unprecedented, reducing research costs and increasing the speed of drug discovery.
 

Our Editors Also Recommend: 

AI’s Drug Revolution, Part 1: Faster Trials and Approvals

From AI to Obesity Drugs to Soaring Costs: Medscape Hot Topics in the Medical Profession Report 2024

AI Voice Analysis for Diabetes Screening Shows Promise

To see the full event recording, click here.
 

A version of this article appeared on Medscape.com.

Summary:

In this segment, the speaker discusses how AI is revolutionizing the drug repurposing process. Previously, drug repurposing was limited by manual research on individual diseases and drugs. With AI, scientists can now analyze a vast array of drugs and diseases simultaneously, generating a ranking system based on the likelihood of success. The Center for Cytokine Storm Treatment and Laboratory, along with the platform Every Cure, uses AI to score 3000 drugs against 18,000 diseases. This platform dramatically reduces the time and resources required for drug repurposing, enabling predictions that can be tested in a fraction of the time.
 

Key Takeaways:

AI is accelerating the drug repurposing process, offering faster and more comprehensive analysis of possible drug-disease matches.

The AI-based platform assigns a likelihood score to each potential match, streamlining the process for testing and validation.

The ability to analyze global biomedical knowledge in 24 hours is unprecedented, reducing research costs and increasing the speed of drug discovery.
 

Our Editors Also Recommend: 

AI’s Drug Revolution, Part 1: Faster Trials and Approvals

From AI to Obesity Drugs to Soaring Costs: Medscape Hot Topics in the Medical Profession Report 2024

AI Voice Analysis for Diabetes Screening Shows Promise

To see the full event recording, click here.
 

A version of this article appeared on Medscape.com.

Summary:

In this segment, the speaker discusses how AI is revolutionizing the drug repurposing process. Previously, drug repurposing was limited by manual research on individual diseases and drugs. With AI, scientists can now analyze a vast array of drugs and diseases simultaneously, generating a ranking system based on the likelihood of success. The Center for Cytokine Storm Treatment and Laboratory, along with the platform Every Cure, uses AI to score 3000 drugs against 18,000 diseases. This platform dramatically reduces the time and resources required for drug repurposing, enabling predictions that can be tested in a fraction of the time.
 

Key Takeaways:

AI is accelerating the drug repurposing process, offering faster and more comprehensive analysis of possible drug-disease matches.

The AI-based platform assigns a likelihood score to each potential match, streamlining the process for testing and validation.

The ability to analyze global biomedical knowledge in 24 hours is unprecedented, reducing research costs and increasing the speed of drug discovery.
 

Our Editors Also Recommend: 

AI’s Drug Revolution, Part 1: Faster Trials and Approvals

From AI to Obesity Drugs to Soaring Costs: Medscape Hot Topics in the Medical Profession Report 2024

AI Voice Analysis for Diabetes Screening Shows Promise

To see the full event recording, click here.
 

A version of this article appeared on Medscape.com.

Some breast cancer types are more likely than others to recur. Researchers have known this for more than a decade.

But they have long wondered why.

“How did those tumor types arise?” said Christina Curtis, PhD, a professor of medicine, genetics and biomedical data science at Stanford University in California. “They’re all breast cancers. They’re all estrogen receptor positive. But these groups are different. When did they become different, and how is that determined?”

Dr. Curtis and colleagues are finally starting to answer these questions. They recently broke new ground in a study linking differences in cancer-related genes to disease subtype and aggressiveness.

Dr. Curtis and colleagues found that, like fingers molding clay, the genes you’re born with can coax the immune system into shape. DNA inherited from our parents is known as the germline genome. It affects whether the immune system attacks or retreats when confronted with variations that may lead to breast cancer.

“It turns out, the germline genome sculpts tumor evolution,” said Dr. Curtis.

The study is part of a growing effort to understand “precancer” — the critical period after cells have started to grow abnormally but before they’ve developed into cancer — a research trend that could trigger a decisive shift in how cancer treatments are realized. Therapeutics could be designed on the basis of the biology of these precancerous cells.

While biotech start-ups push new tests to catch cancer early, researchers like Dr. Curtis hope to stop cancer before it even starts.

“This is a really exciting area of research,” said Susan Domchek, MD, executive director of the Basser Center for BRCA at the University of Pennsylvania, Philadelphia, who was not involved in the study. “What we hope for is that, over time, we’re going to have more and more biologically driven interception.”
 

‘We’re Basically Unearthing the Dark Matter of the Human Genome’

Of course, we already have mechanical ways of heading off cancer, like having a precancerous polyp removed. But for the Stanford researchers, biologic interception is the goal. They hope to figure out how to use the immune system to stop the cancer.

In their study, they looked at DNA variabilities known as somatic aberrations or single-nucleotide protein sequences (SNPs). The HER2 gene, for example, can contain SNPs — possibly affecting how the HER2 protein regulates breast cell growth and division.

“There’s been a huge effort through genomewide association studies to link SNPs to cancer outcomes and risk,” Dr. Curtis said.

Focusing on people with a genetic predisposition for breast cancer, Dr. Curtis used machine learning to show that these variabilities can occur in specific epitopes (protein features that can trigger an immune response).

They also found that heightened variability can show up in a region of the genome called the human leukocyte antigen (HLA). Each HLA molecule can contain many epitopes.

“We developed a whole new algorithm to compute this ‘germline epitope burden,’ ” Dr. Curtis said. “We’re basically unearthing the dark matter of the human genome to ask about the interplay between SNPs and HLA class one presentation.”

These aberration-rich regions can grab the immune system’s attention. Sometimes the immune system identifies and eradicates those epitopes.

In that case: “I have immunosurveillance. I’ve cured my cancer,” said Nora Disis, PhD, director of the Cancer Vaccine Institute and a professor of medicine at the University of Washington, Seattle. Dr. Disis was not involved in the study.

But other times, the immune system finds a way around the high “epitope burden,” and the tumors become more aggressive and immunosuppressive. That’s when cancer forms.

This suggests a “critical juncture between preinvasive and invasive disease,” Dr. Curtis said.

And that “critical juncture” may very well be the optimal time for intervention.
 

The Precancer Push

Stanford’s findings add information to prior biomarkers and may provide a way to identify “bad-acting tumors” from a simple blood draw measuring germline epitope burden, Dr. Curtis said. Looking further ahead, “this also reveals a new source of epitopes that might be immunogenic and might be informative for the development of vaccines.”

Many labs are trying to understand the biology of precancer and exploring possible vaccines.

The National Cancer Institute’s Human Tumor Atlas Network is building three-dimensional models of the evolution from precancerous to advanced disease. And researchers at the Cancer Vaccine Institute at the University of Washington are developing a vaccine for a precancerous lesion linked to many ovarian cancers.

Dr. Domchek’s research explores whether breast cancers caused by mutations in the BRCA 1 and 2 genes can be intercepted at very early stages. In a clinical trial of healthy people with those mutations, Dr. Domchek and colleagues are attempting to “rev up the immune system to tackle telomerase,” an enzyme that’s over-expressed in 95% of cancers. The hope is for this experimental vaccine to lower their risk of developing cancer.

At the Fred Hutch Cancer Center, Seattle, Ming Yu, PhD, is studying how senescent cells affect immune cells in precancer. As cells age and stop dividing, she said, they can accumulate and create a “tumor-promoting microenvironment” in older people.

Dr. Yu has found that the antiaging drug rapamycin can eliminate those “zombie cells” in mice. She’s studying whether the “cleanup” can help prevent cancer and expects results in a few months.

In the years and decades to come, all of this could lead to a new era in cancer treatment.

“Most drug development starts with people with advanced cancer and then goes into the earlier and earlier spaces,” said Dr. Domchek. “But it may be that we’re thinking about it all wrong and that you really have to understand the unique biology of early lesions to go after them.”

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

Some breast cancer types are more likely than others to recur. Researchers have known this for more than a decade.

But they have long wondered why.

“How did those tumor types arise?” said Christina Curtis, PhD, a professor of medicine, genetics and biomedical data science at Stanford University in California. “They’re all breast cancers. They’re all estrogen receptor positive. But these groups are different. When did they become different, and how is that determined?”

Dr. Curtis and colleagues are finally starting to answer these questions. They recently broke new ground in a study linking differences in cancer-related genes to disease subtype and aggressiveness.

Dr. Curtis and colleagues found that, like fingers molding clay, the genes you’re born with can coax the immune system into shape. DNA inherited from our parents is known as the germline genome. It affects whether the immune system attacks or retreats when confronted with variations that may lead to breast cancer.

“It turns out, the germline genome sculpts tumor evolution,” said Dr. Curtis.

The study is part of a growing effort to understand “precancer” — the critical period after cells have started to grow abnormally but before they’ve developed into cancer — a research trend that could trigger a decisive shift in how cancer treatments are realized. Therapeutics could be designed on the basis of the biology of these precancerous cells.

While biotech start-ups push new tests to catch cancer early, researchers like Dr. Curtis hope to stop cancer before it even starts.

“This is a really exciting area of research,” said Susan Domchek, MD, executive director of the Basser Center for BRCA at the University of Pennsylvania, Philadelphia, who was not involved in the study. “What we hope for is that, over time, we’re going to have more and more biologically driven interception.”
 

‘We’re Basically Unearthing the Dark Matter of the Human Genome’

Of course, we already have mechanical ways of heading off cancer, like having a precancerous polyp removed. But for the Stanford researchers, biologic interception is the goal. They hope to figure out how to use the immune system to stop the cancer.

In their study, they looked at DNA variabilities known as somatic aberrations or single-nucleotide protein sequences (SNPs). The HER2 gene, for example, can contain SNPs — possibly affecting how the HER2 protein regulates breast cell growth and division.

“There’s been a huge effort through genomewide association studies to link SNPs to cancer outcomes and risk,” Dr. Curtis said.

Focusing on people with a genetic predisposition for breast cancer, Dr. Curtis used machine learning to show that these variabilities can occur in specific epitopes (protein features that can trigger an immune response).

They also found that heightened variability can show up in a region of the genome called the human leukocyte antigen (HLA). Each HLA molecule can contain many epitopes.

“We developed a whole new algorithm to compute this ‘germline epitope burden,’ ” Dr. Curtis said. “We’re basically unearthing the dark matter of the human genome to ask about the interplay between SNPs and HLA class one presentation.”

These aberration-rich regions can grab the immune system’s attention. Sometimes the immune system identifies and eradicates those epitopes.

In that case: “I have immunosurveillance. I’ve cured my cancer,” said Nora Disis, PhD, director of the Cancer Vaccine Institute and a professor of medicine at the University of Washington, Seattle. Dr. Disis was not involved in the study.

But other times, the immune system finds a way around the high “epitope burden,” and the tumors become more aggressive and immunosuppressive. That’s when cancer forms.

This suggests a “critical juncture between preinvasive and invasive disease,” Dr. Curtis said.

And that “critical juncture” may very well be the optimal time for intervention.
 

The Precancer Push

Stanford’s findings add information to prior biomarkers and may provide a way to identify “bad-acting tumors” from a simple blood draw measuring germline epitope burden, Dr. Curtis said. Looking further ahead, “this also reveals a new source of epitopes that might be immunogenic and might be informative for the development of vaccines.”

Many labs are trying to understand the biology of precancer and exploring possible vaccines.

The National Cancer Institute’s Human Tumor Atlas Network is building three-dimensional models of the evolution from precancerous to advanced disease. And researchers at the Cancer Vaccine Institute at the University of Washington are developing a vaccine for a precancerous lesion linked to many ovarian cancers.

Dr. Domchek’s research explores whether breast cancers caused by mutations in the BRCA 1 and 2 genes can be intercepted at very early stages. In a clinical trial of healthy people with those mutations, Dr. Domchek and colleagues are attempting to “rev up the immune system to tackle telomerase,” an enzyme that’s over-expressed in 95% of cancers. The hope is for this experimental vaccine to lower their risk of developing cancer.

At the Fred Hutch Cancer Center, Seattle, Ming Yu, PhD, is studying how senescent cells affect immune cells in precancer. As cells age and stop dividing, she said, they can accumulate and create a “tumor-promoting microenvironment” in older people.

Dr. Yu has found that the antiaging drug rapamycin can eliminate those “zombie cells” in mice. She’s studying whether the “cleanup” can help prevent cancer and expects results in a few months.

In the years and decades to come, all of this could lead to a new era in cancer treatment.

“Most drug development starts with people with advanced cancer and then goes into the earlier and earlier spaces,” said Dr. Domchek. “But it may be that we’re thinking about it all wrong and that you really have to understand the unique biology of early lesions to go after them.”

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

Some breast cancer types are more likely than others to recur. Researchers have known this for more than a decade.

But they have long wondered why.

“How did those tumor types arise?” said Christina Curtis, PhD, a professor of medicine, genetics and biomedical data science at Stanford University in California. “They’re all breast cancers. They’re all estrogen receptor positive. But these groups are different. When did they become different, and how is that determined?”

Dr. Curtis and colleagues are finally starting to answer these questions. They recently broke new ground in a study linking differences in cancer-related genes to disease subtype and aggressiveness.

Dr. Curtis and colleagues found that, like fingers molding clay, the genes you’re born with can coax the immune system into shape. DNA inherited from our parents is known as the germline genome. It affects whether the immune system attacks or retreats when confronted with variations that may lead to breast cancer.

“It turns out, the germline genome sculpts tumor evolution,” said Dr. Curtis.

The study is part of a growing effort to understand “precancer” — the critical period after cells have started to grow abnormally but before they’ve developed into cancer — a research trend that could trigger a decisive shift in how cancer treatments are realized. Therapeutics could be designed on the basis of the biology of these precancerous cells.

While biotech start-ups push new tests to catch cancer early, researchers like Dr. Curtis hope to stop cancer before it even starts.

“This is a really exciting area of research,” said Susan Domchek, MD, executive director of the Basser Center for BRCA at the University of Pennsylvania, Philadelphia, who was not involved in the study. “What we hope for is that, over time, we’re going to have more and more biologically driven interception.”
 

‘We’re Basically Unearthing the Dark Matter of the Human Genome’

Of course, we already have mechanical ways of heading off cancer, like having a precancerous polyp removed. But for the Stanford researchers, biologic interception is the goal. They hope to figure out how to use the immune system to stop the cancer.

In their study, they looked at DNA variabilities known as somatic aberrations or single-nucleotide protein sequences (SNPs). The HER2 gene, for example, can contain SNPs — possibly affecting how the HER2 protein regulates breast cell growth and division.

“There’s been a huge effort through genomewide association studies to link SNPs to cancer outcomes and risk,” Dr. Curtis said.

Focusing on people with a genetic predisposition for breast cancer, Dr. Curtis used machine learning to show that these variabilities can occur in specific epitopes (protein features that can trigger an immune response).

They also found that heightened variability can show up in a region of the genome called the human leukocyte antigen (HLA). Each HLA molecule can contain many epitopes.

“We developed a whole new algorithm to compute this ‘germline epitope burden,’ ” Dr. Curtis said. “We’re basically unearthing the dark matter of the human genome to ask about the interplay between SNPs and HLA class one presentation.”

These aberration-rich regions can grab the immune system’s attention. Sometimes the immune system identifies and eradicates those epitopes.

In that case: “I have immunosurveillance. I’ve cured my cancer,” said Nora Disis, PhD, director of the Cancer Vaccine Institute and a professor of medicine at the University of Washington, Seattle. Dr. Disis was not involved in the study.

But other times, the immune system finds a way around the high “epitope burden,” and the tumors become more aggressive and immunosuppressive. That’s when cancer forms.

This suggests a “critical juncture between preinvasive and invasive disease,” Dr. Curtis said.

And that “critical juncture” may very well be the optimal time for intervention.
 

The Precancer Push

Stanford’s findings add information to prior biomarkers and may provide a way to identify “bad-acting tumors” from a simple blood draw measuring germline epitope burden, Dr. Curtis said. Looking further ahead, “this also reveals a new source of epitopes that might be immunogenic and might be informative for the development of vaccines.”

Many labs are trying to understand the biology of precancer and exploring possible vaccines.

The National Cancer Institute’s Human Tumor Atlas Network is building three-dimensional models of the evolution from precancerous to advanced disease. And researchers at the Cancer Vaccine Institute at the University of Washington are developing a vaccine for a precancerous lesion linked to many ovarian cancers.

Dr. Domchek’s research explores whether breast cancers caused by mutations in the BRCA 1 and 2 genes can be intercepted at very early stages. In a clinical trial of healthy people with those mutations, Dr. Domchek and colleagues are attempting to “rev up the immune system to tackle telomerase,” an enzyme that’s over-expressed in 95% of cancers. The hope is for this experimental vaccine to lower their risk of developing cancer.

At the Fred Hutch Cancer Center, Seattle, Ming Yu, PhD, is studying how senescent cells affect immune cells in precancer. As cells age and stop dividing, she said, they can accumulate and create a “tumor-promoting microenvironment” in older people.

Dr. Yu has found that the antiaging drug rapamycin can eliminate those “zombie cells” in mice. She’s studying whether the “cleanup” can help prevent cancer and expects results in a few months.

In the years and decades to come, all of this could lead to a new era in cancer treatment.

“Most drug development starts with people with advanced cancer and then goes into the earlier and earlier spaces,” said Dr. Domchek. “But it may be that we’re thinking about it all wrong and that you really have to understand the unique biology of early lesions to go after them.”

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

Before the 350 residents finalized their union contract at the University of Vermont (UVM) Medical Center, Burlington, in 2022, Jesse Mostoller, DO, now a third-year pathology resident, recalls hearing about another resident at the hospital who resorted to moonlighting as an Uber driver to make ends meet.

“In Vermont, rent and childcare are expensive,” said Dr. Mostoller, adding that, thanks to union bargaining, first-year residents at UVM are now paid $71,000 per year instead of $61,000. In addition, residents now receive $1800 per year for food (up from $200-$300 annually) and a $1800 annual fund to help pay for board exams that can be carried over for 2 years. “When we were negotiating, the biggest item on our list of demands was to help alleviate the financial pressure residents have been facing for years.”

The UVM residents’ collective bargaining also includes a cap on working hours so that residents don’t work 80 hours a week, paid parental leave, affordable housing, and funds for education and wellness.

These are some of the most common challenges that are faced by residents all over the country, said A. Taylor Walker, MD, MPH, family medicine chief physician at Tufts University School of Medicine/Cambridge Health Alliance in Boston, Massachusetts, and national president of the Committee of Interns and Residents (CIR), which is part of the Service Employees International Union.

For these reasons, residents at Montefiore Medical Center, Stanford Health Care, George Washington University, and the University of Pennsylvania have recently voted to unionize, according to Dr. Walker.

And while there are several small local unions that have picked up residents at local hospitals, CIR is the largest union of physicians in the United States, with a total of 33,000 residents and fellows across the country (15% of the staff at more than 60 hospitals nationwide).

“We’ve doubled in size in the last 4 years,” said Dr. Walker. “The reason is that we’re in a national reckoning on the corporatization of American medicine and the way in which graduate medical education is rooted in a cycle of exploitation that doesn’t center on the health, well-being, or safety of our doctors and ultimately negatively affects our patients.”

Here’s what residents are fighting for — right now.
 

Adequate Parental Leave

Christopher Domanski, MD, a first-year resident in psychiatry at California Pacific Medical Center (CPMC) in San Francisco, is also a new dad to a 5-month-old son and is currently in the sixth week of parental leave. One goal of CPMC’s union, started a year and a half ago, is to expand parental leave to 8 weeks.

“I started as a resident here in mid-June, but the fight with CPMC leaders has been going on for a year and a half,” Dr. Domanski said. “It can feel very frustrating because many times there’s no budge in the conversations we want to have.”

Contract negotiations here continue to be slow — and arduous.

“It goes back and forth,” said Dr. Domanski, who makes about $75,000 a year. “Sometimes they listen to our proposals, but they deny the vast majority or make a paltry increase in salary or time off. It goes like this: We’ll have a negotiation; we’ll talk about it, and then they say, ‘we’re not comfortable doing this’ and it stalls again.”

If a resident hasn’t started a family yet, access to fertility benefits and reproductive healthcare is paramount because most residents are in their 20s and 30s, Dr. Walker said.

“Our reproductive futures are really hindered by what care we have access to and what care is covered,” she added. “We don’t make enough money to pay for reproductive care out of pocket.”
 

Fair Pay

In Boston, the residents at Mass General Brigham certified their union in June 2023, but they still don’t have a contract.

“When I applied for a residency in September 2023, I spoke to the folks here, and I was basically under the impression that we would have a contract by the time I matched,” said Madison Masters, MD, a resident in internal medicine. “We are not there.”

This timeline isn’t unusual — the 1400 Penn Medicine residents who unionized in 2023 only recently secured a tentative union contract at the end of September, and at Stanford, the process to ratify their first contract took 13 months.

Still, the salary issue remains frustrating as resident compensation doesn’t line up with the cost of living or the amount of work residents do, said Dr. Masters, who says starting salaries at Mass General Brigham are $78,500 plus a $10,000 stipend for housing.

“There’s been a long tradition of underpaying residents — we’re treated like trainees, but we’re also a primary labor force,” Dr. Masters said, adding that nurse practitioners and physician assistants are paid almost twice as much as residents — some make $120,000 per year or more, while the salary range for residents nationwide is $49,000-$65,000 per year.

“Every time we discuss the contract and talk about a financial package, they offer a 1.5% raise for the next 3 years while we had asked for closer to 8%,” Dr. Masters said. “Then, when they come back for the next bargaining session, they go up a quarter of a percent each time. Recently, they said we will need to go to a mediator to try and resolve this.”
 

Adequate Healthcare

The biggest — and perhaps the most shocking — ask is for robust health insurance coverage.

“At my hospital, they’re telling us to get Amazon One Medical for health insurance,” Dr. Masters said. “They’re saying it’s hard for anyone to get primary care coverage here.”

Inadequate health insurance is a big issue, as burnout among residents and fellows remains a problem. At UVM, a $10,000 annual wellness stipend has helped address some of these issues. Even so, union members at UVM are planning to return to the table within 18 months to continue their collective bargaining.

The ability to access mental health services anywhere you want is also critical for residents, Dr. Walker said.

“If you can only go to a therapist at your own institution, there is a hesitation to utilize that specialist if that’s even offered,” Dr. Walker said. “Do you want to go to therapy with a colleague? Probably not.”

Ultimately, the residents we spoke to are committed to fighting for their workplace rights — no matter how time-consuming or difficult this has been.

“No administration wants us to have to have a union, but it’s necessary,” Dr. Mostoller said. “As an individual, you don’t have leverage to get a seat at the table, but now we have a seat at the table. We have a wonderful contract, but we’re going to keep fighting to make it even better.”

Paving the way for future residents is a key motivator, too.

“There’s this idea of leaving the campsite cleaner than you found it,” Dr. Mostoller told this news organization. “It’s the same thing here — we’re trying to fix this so that the next generation of residents won’t have to.”

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

Before the 350 residents finalized their union contract at the University of Vermont (UVM) Medical Center, Burlington, in 2022, Jesse Mostoller, DO, now a third-year pathology resident, recalls hearing about another resident at the hospital who resorted to moonlighting as an Uber driver to make ends meet.

“In Vermont, rent and childcare are expensive,” said Dr. Mostoller, adding that, thanks to union bargaining, first-year residents at UVM are now paid $71,000 per year instead of $61,000. In addition, residents now receive $1800 per year for food (up from $200-$300 annually) and a $1800 annual fund to help pay for board exams that can be carried over for 2 years. “When we were negotiating, the biggest item on our list of demands was to help alleviate the financial pressure residents have been facing for years.”

The UVM residents’ collective bargaining also includes a cap on working hours so that residents don’t work 80 hours a week, paid parental leave, affordable housing, and funds for education and wellness.

These are some of the most common challenges that are faced by residents all over the country, said A. Taylor Walker, MD, MPH, family medicine chief physician at Tufts University School of Medicine/Cambridge Health Alliance in Boston, Massachusetts, and national president of the Committee of Interns and Residents (CIR), which is part of the Service Employees International Union.

For these reasons, residents at Montefiore Medical Center, Stanford Health Care, George Washington University, and the University of Pennsylvania have recently voted to unionize, according to Dr. Walker.

And while there are several small local unions that have picked up residents at local hospitals, CIR is the largest union of physicians in the United States, with a total of 33,000 residents and fellows across the country (15% of the staff at more than 60 hospitals nationwide).

“We’ve doubled in size in the last 4 years,” said Dr. Walker. “The reason is that we’re in a national reckoning on the corporatization of American medicine and the way in which graduate medical education is rooted in a cycle of exploitation that doesn’t center on the health, well-being, or safety of our doctors and ultimately negatively affects our patients.”

Here’s what residents are fighting for — right now.
 

Adequate Parental Leave

Christopher Domanski, MD, a first-year resident in psychiatry at California Pacific Medical Center (CPMC) in San Francisco, is also a new dad to a 5-month-old son and is currently in the sixth week of parental leave. One goal of CPMC’s union, started a year and a half ago, is to expand parental leave to 8 weeks.

“I started as a resident here in mid-June, but the fight with CPMC leaders has been going on for a year and a half,” Dr. Domanski said. “It can feel very frustrating because many times there’s no budge in the conversations we want to have.”

Contract negotiations here continue to be slow — and arduous.

“It goes back and forth,” said Dr. Domanski, who makes about $75,000 a year. “Sometimes they listen to our proposals, but they deny the vast majority or make a paltry increase in salary or time off. It goes like this: We’ll have a negotiation; we’ll talk about it, and then they say, ‘we’re not comfortable doing this’ and it stalls again.”

If a resident hasn’t started a family yet, access to fertility benefits and reproductive healthcare is paramount because most residents are in their 20s and 30s, Dr. Walker said.

“Our reproductive futures are really hindered by what care we have access to and what care is covered,” she added. “We don’t make enough money to pay for reproductive care out of pocket.”
 

Fair Pay

In Boston, the residents at Mass General Brigham certified their union in June 2023, but they still don’t have a contract.

“When I applied for a residency in September 2023, I spoke to the folks here, and I was basically under the impression that we would have a contract by the time I matched,” said Madison Masters, MD, a resident in internal medicine. “We are not there.”

This timeline isn’t unusual — the 1400 Penn Medicine residents who unionized in 2023 only recently secured a tentative union contract at the end of September, and at Stanford, the process to ratify their first contract took 13 months.

Still, the salary issue remains frustrating as resident compensation doesn’t line up with the cost of living or the amount of work residents do, said Dr. Masters, who says starting salaries at Mass General Brigham are $78,500 plus a $10,000 stipend for housing.

“There’s been a long tradition of underpaying residents — we’re treated like trainees, but we’re also a primary labor force,” Dr. Masters said, adding that nurse practitioners and physician assistants are paid almost twice as much as residents — some make $120,000 per year or more, while the salary range for residents nationwide is $49,000-$65,000 per year.

“Every time we discuss the contract and talk about a financial package, they offer a 1.5% raise for the next 3 years while we had asked for closer to 8%,” Dr. Masters said. “Then, when they come back for the next bargaining session, they go up a quarter of a percent each time. Recently, they said we will need to go to a mediator to try and resolve this.”
 

Adequate Healthcare

The biggest — and perhaps the most shocking — ask is for robust health insurance coverage.

“At my hospital, they’re telling us to get Amazon One Medical for health insurance,” Dr. Masters said. “They’re saying it’s hard for anyone to get primary care coverage here.”

Inadequate health insurance is a big issue, as burnout among residents and fellows remains a problem. At UVM, a $10,000 annual wellness stipend has helped address some of these issues. Even so, union members at UVM are planning to return to the table within 18 months to continue their collective bargaining.

The ability to access mental health services anywhere you want is also critical for residents, Dr. Walker said.

“If you can only go to a therapist at your own institution, there is a hesitation to utilize that specialist if that’s even offered,” Dr. Walker said. “Do you want to go to therapy with a colleague? Probably not.”

Ultimately, the residents we spoke to are committed to fighting for their workplace rights — no matter how time-consuming or difficult this has been.

“No administration wants us to have to have a union, but it’s necessary,” Dr. Mostoller said. “As an individual, you don’t have leverage to get a seat at the table, but now we have a seat at the table. We have a wonderful contract, but we’re going to keep fighting to make it even better.”

Paving the way for future residents is a key motivator, too.

“There’s this idea of leaving the campsite cleaner than you found it,” Dr. Mostoller told this news organization. “It’s the same thing here — we’re trying to fix this so that the next generation of residents won’t have to.”

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

Before the 350 residents finalized their union contract at the University of Vermont (UVM) Medical Center, Burlington, in 2022, Jesse Mostoller, DO, now a third-year pathology resident, recalls hearing about another resident at the hospital who resorted to moonlighting as an Uber driver to make ends meet.

“In Vermont, rent and childcare are expensive,” said Dr. Mostoller, adding that, thanks to union bargaining, first-year residents at UVM are now paid $71,000 per year instead of $61,000. In addition, residents now receive $1800 per year for food (up from $200-$300 annually) and a $1800 annual fund to help pay for board exams that can be carried over for 2 years. “When we were negotiating, the biggest item on our list of demands was to help alleviate the financial pressure residents have been facing for years.”

The UVM residents’ collective bargaining also includes a cap on working hours so that residents don’t work 80 hours a week, paid parental leave, affordable housing, and funds for education and wellness.

These are some of the most common challenges that are faced by residents all over the country, said A. Taylor Walker, MD, MPH, family medicine chief physician at Tufts University School of Medicine/Cambridge Health Alliance in Boston, Massachusetts, and national president of the Committee of Interns and Residents (CIR), which is part of the Service Employees International Union.

For these reasons, residents at Montefiore Medical Center, Stanford Health Care, George Washington University, and the University of Pennsylvania have recently voted to unionize, according to Dr. Walker.

And while there are several small local unions that have picked up residents at local hospitals, CIR is the largest union of physicians in the United States, with a total of 33,000 residents and fellows across the country (15% of the staff at more than 60 hospitals nationwide).

“We’ve doubled in size in the last 4 years,” said Dr. Walker. “The reason is that we’re in a national reckoning on the corporatization of American medicine and the way in which graduate medical education is rooted in a cycle of exploitation that doesn’t center on the health, well-being, or safety of our doctors and ultimately negatively affects our patients.”

Here’s what residents are fighting for — right now.
 

Adequate Parental Leave

Christopher Domanski, MD, a first-year resident in psychiatry at California Pacific Medical Center (CPMC) in San Francisco, is also a new dad to a 5-month-old son and is currently in the sixth week of parental leave. One goal of CPMC’s union, started a year and a half ago, is to expand parental leave to 8 weeks.

“I started as a resident here in mid-June, but the fight with CPMC leaders has been going on for a year and a half,” Dr. Domanski said. “It can feel very frustrating because many times there’s no budge in the conversations we want to have.”

Contract negotiations here continue to be slow — and arduous.

“It goes back and forth,” said Dr. Domanski, who makes about $75,000 a year. “Sometimes they listen to our proposals, but they deny the vast majority or make a paltry increase in salary or time off. It goes like this: We’ll have a negotiation; we’ll talk about it, and then they say, ‘we’re not comfortable doing this’ and it stalls again.”

If a resident hasn’t started a family yet, access to fertility benefits and reproductive healthcare is paramount because most residents are in their 20s and 30s, Dr. Walker said.

“Our reproductive futures are really hindered by what care we have access to and what care is covered,” she added. “We don’t make enough money to pay for reproductive care out of pocket.”
 

Fair Pay

In Boston, the residents at Mass General Brigham certified their union in June 2023, but they still don’t have a contract.

“When I applied for a residency in September 2023, I spoke to the folks here, and I was basically under the impression that we would have a contract by the time I matched,” said Madison Masters, MD, a resident in internal medicine. “We are not there.”

This timeline isn’t unusual — the 1400 Penn Medicine residents who unionized in 2023 only recently secured a tentative union contract at the end of September, and at Stanford, the process to ratify their first contract took 13 months.

Still, the salary issue remains frustrating as resident compensation doesn’t line up with the cost of living or the amount of work residents do, said Dr. Masters, who says starting salaries at Mass General Brigham are $78,500 plus a $10,000 stipend for housing.

“There’s been a long tradition of underpaying residents — we’re treated like trainees, but we’re also a primary labor force,” Dr. Masters said, adding that nurse practitioners and physician assistants are paid almost twice as much as residents — some make $120,000 per year or more, while the salary range for residents nationwide is $49,000-$65,000 per year.

“Every time we discuss the contract and talk about a financial package, they offer a 1.5% raise for the next 3 years while we had asked for closer to 8%,” Dr. Masters said. “Then, when they come back for the next bargaining session, they go up a quarter of a percent each time. Recently, they said we will need to go to a mediator to try and resolve this.”
 

Adequate Healthcare

The biggest — and perhaps the most shocking — ask is for robust health insurance coverage.

“At my hospital, they’re telling us to get Amazon One Medical for health insurance,” Dr. Masters said. “They’re saying it’s hard for anyone to get primary care coverage here.”

Inadequate health insurance is a big issue, as burnout among residents and fellows remains a problem. At UVM, a $10,000 annual wellness stipend has helped address some of these issues. Even so, union members at UVM are planning to return to the table within 18 months to continue their collective bargaining.

The ability to access mental health services anywhere you want is also critical for residents, Dr. Walker said.

“If you can only go to a therapist at your own institution, there is a hesitation to utilize that specialist if that’s even offered,” Dr. Walker said. “Do you want to go to therapy with a colleague? Probably not.”

Ultimately, the residents we spoke to are committed to fighting for their workplace rights — no matter how time-consuming or difficult this has been.

“No administration wants us to have to have a union, but it’s necessary,” Dr. Mostoller said. “As an individual, you don’t have leverage to get a seat at the table, but now we have a seat at the table. We have a wonderful contract, but we’re going to keep fighting to make it even better.”

Paving the way for future residents is a key motivator, too.

“There’s this idea of leaving the campsite cleaner than you found it,” Dr. Mostoller told this news organization. “It’s the same thing here — we’re trying to fix this so that the next generation of residents won’t have to.”

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