Ob.Gyn. News

As three federal agencies investigate how private equity ownership and consolidation of healthcare organizations affects patient care and costs, physicians are giving them an earful.

“Before I retired, I could already see the damage private equity was doing to hospitals and medical practices. Well-regarded physician groups were being bought and the respected doctors and staff forced out to squeeze out profit for the buyers. Hospital-based physicians were being hit especially hard,” wrote Rhonda Wright, MD, of Brookhaven, Georgia. 

“Now, the rot is setting in for emergency rooms. One in four ERs is now (under-)staffed by private equity firms. This is leading to longer wait times, deterioration in patient care, and higher bills,” Dr. Wright continued. “Private equity takeover of medicine must be stopped. All such deals should be strictly regulated and should be heavily scrutinized, if not barred altogether. Our health depends upon it!”

The federal government is accepting public comments like Dr. Wright’s through June 5 and has even set up a website (healthycompetition.gov) to make it easier to file complaints against health organizations possibly violating antitrust laws.

The US Department of Justice’s Antitrust Division, the Federal Trade Commission (FTC), and the Department of Health and Human Services want to hear from physicians and the public about how private equity firms’ investments in healthcare entities, such as hospitals, nursing homes, or specialty service providers, affect patients and healthcare workers. The investigation will also evaluate how market pricing, competition, and referral patterns change when practices and hospitals are acquired by health systems or insurers.

Maintaining competition in the provider and payer markets benefits healthcare workers through higher pay, while patients can access quality care at lower prices, the joint request for information said. However, consolidation and mergers — potentially driven by private equity’s entry into the market — can diminish these benefits.

Investigating private equity and consolidation in medicine is part of the Biden Administration’s focus on lowering medical and prescription drug costs and strengthening competition in healthcare. The FTC’s vote last week to ban noncompete agreements, which business groups have vowed to challenge in court, falls under the same initiative.

Alexandra Nicole Thran, MD, FACEP, president of the Vermont Chapter of the American College of Emergency Physicians, said that the private equity business model is problematic because it ties physicians’ wages to patient satisfaction and the number of patients they see per hour. 

A Connecticut primary care physician expressed similar sentiments. “Physicians are being forced into a system where corporations provide financial incentives and punitive policies to direct healthcare decisions towards a profitable aim,” said Eric Schwaber, MD. 

While a majority of comments criticized the role of private equity and consolidation, some reflected a more positive view. 

“Private equity helps make healthcare more efficient and effective. It brings needed operational and managerial expertise to allow for better patient care,” said Reenie Abraham, MD, an associate professor in the Department of Internal Medicine at University of Texas Southwestern Medical Center, Dallas. The University of Texas is facing a lawsuit involving the liability status of its physicians who work for a private equity-backed hospital partly owned by the university.

Several public comments point to the increasing market influence UnitedHealth Group (UHG) and other payers have obtained through recent acquisitions. Retired emergency room physician Scott Davis, MD, said that the “astronomical” rate of burnout among providers has been exacerbated by “the economic takeover of the healthcare system by…United Healthcare [and] private equity groups who put profits over anything else.”  

The healthcare conglomerate employs approximately 10% of active US physicians, including many through its subsidiary, Optum Health, which provides primary, urgent, and surgical care. UHG has also invested heavily in acquiring physician practices to advance its value-based care model.

“If a publicly traded private insurance or private equity company is interested in their short-term quarterly profits or stock price, there is little interest in the…effective management of chronic disease, other than that which fulfills a ‘value-based’ metric,” wrote Kenneth Dolkart, MD, FACP, clinical assistant professor at the Dartmouth Geisel School of Medicine in Hanover, New Hampshire. 

Sarah Ealy, a revenue cycle professional, commented that payers like UHG have outsized bargaining power when negotiating rates with providers. “In many states, United Healthcare and its subsidiaries pay a lower reimbursement rate than state Medicaid plans — these rates are nearly 50% of the breakeven per-visit rate that practices need to keep the lights on.”

Another comment ties the recent cyberattack on UHG-owned Change Healthcare to private equity ownership and “healthcare behemoths buying up practices and data.”

“The ramrodding of consolidation and private oversight with little to no barriers to foreign intrusions…is a testament to how ill prepared [the] US market is to private equity healthcare takeovers,” said SW Dermatology Practice LLC. 

The agencies request comments from all health market participants, including physicians, nurses, employers, administrators, and patients.

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

As three federal agencies investigate how private equity ownership and consolidation of healthcare organizations affects patient care and costs, physicians are giving them an earful.

“Before I retired, I could already see the damage private equity was doing to hospitals and medical practices. Well-regarded physician groups were being bought and the respected doctors and staff forced out to squeeze out profit for the buyers. Hospital-based physicians were being hit especially hard,” wrote Rhonda Wright, MD, of Brookhaven, Georgia. 

“Now, the rot is setting in for emergency rooms. One in four ERs is now (under-)staffed by private equity firms. This is leading to longer wait times, deterioration in patient care, and higher bills,” Dr. Wright continued. “Private equity takeover of medicine must be stopped. All such deals should be strictly regulated and should be heavily scrutinized, if not barred altogether. Our health depends upon it!”

The federal government is accepting public comments like Dr. Wright’s through June 5 and has even set up a website (healthycompetition.gov) to make it easier to file complaints against health organizations possibly violating antitrust laws.

The US Department of Justice’s Antitrust Division, the Federal Trade Commission (FTC), and the Department of Health and Human Services want to hear from physicians and the public about how private equity firms’ investments in healthcare entities, such as hospitals, nursing homes, or specialty service providers, affect patients and healthcare workers. The investigation will also evaluate how market pricing, competition, and referral patterns change when practices and hospitals are acquired by health systems or insurers.

Maintaining competition in the provider and payer markets benefits healthcare workers through higher pay, while patients can access quality care at lower prices, the joint request for information said. However, consolidation and mergers — potentially driven by private equity’s entry into the market — can diminish these benefits.

Investigating private equity and consolidation in medicine is part of the Biden Administration’s focus on lowering medical and prescription drug costs and strengthening competition in healthcare. The FTC’s vote last week to ban noncompete agreements, which business groups have vowed to challenge in court, falls under the same initiative.

Alexandra Nicole Thran, MD, FACEP, president of the Vermont Chapter of the American College of Emergency Physicians, said that the private equity business model is problematic because it ties physicians’ wages to patient satisfaction and the number of patients they see per hour. 

A Connecticut primary care physician expressed similar sentiments. “Physicians are being forced into a system where corporations provide financial incentives and punitive policies to direct healthcare decisions towards a profitable aim,” said Eric Schwaber, MD. 

While a majority of comments criticized the role of private equity and consolidation, some reflected a more positive view. 

“Private equity helps make healthcare more efficient and effective. It brings needed operational and managerial expertise to allow for better patient care,” said Reenie Abraham, MD, an associate professor in the Department of Internal Medicine at University of Texas Southwestern Medical Center, Dallas. The University of Texas is facing a lawsuit involving the liability status of its physicians who work for a private equity-backed hospital partly owned by the university.

Several public comments point to the increasing market influence UnitedHealth Group (UHG) and other payers have obtained through recent acquisitions. Retired emergency room physician Scott Davis, MD, said that the “astronomical” rate of burnout among providers has been exacerbated by “the economic takeover of the healthcare system by…United Healthcare [and] private equity groups who put profits over anything else.”  

The healthcare conglomerate employs approximately 10% of active US physicians, including many through its subsidiary, Optum Health, which provides primary, urgent, and surgical care. UHG has also invested heavily in acquiring physician practices to advance its value-based care model.

“If a publicly traded private insurance or private equity company is interested in their short-term quarterly profits or stock price, there is little interest in the…effective management of chronic disease, other than that which fulfills a ‘value-based’ metric,” wrote Kenneth Dolkart, MD, FACP, clinical assistant professor at the Dartmouth Geisel School of Medicine in Hanover, New Hampshire. 

Sarah Ealy, a revenue cycle professional, commented that payers like UHG have outsized bargaining power when negotiating rates with providers. “In many states, United Healthcare and its subsidiaries pay a lower reimbursement rate than state Medicaid plans — these rates are nearly 50% of the breakeven per-visit rate that practices need to keep the lights on.”

Another comment ties the recent cyberattack on UHG-owned Change Healthcare to private equity ownership and “healthcare behemoths buying up practices and data.”

“The ramrodding of consolidation and private oversight with little to no barriers to foreign intrusions…is a testament to how ill prepared [the] US market is to private equity healthcare takeovers,” said SW Dermatology Practice LLC. 

The agencies request comments from all health market participants, including physicians, nurses, employers, administrators, and patients.

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

As three federal agencies investigate how private equity ownership and consolidation of healthcare organizations affects patient care and costs, physicians are giving them an earful.

“Before I retired, I could already see the damage private equity was doing to hospitals and medical practices. Well-regarded physician groups were being bought and the respected doctors and staff forced out to squeeze out profit for the buyers. Hospital-based physicians were being hit especially hard,” wrote Rhonda Wright, MD, of Brookhaven, Georgia. 

“Now, the rot is setting in for emergency rooms. One in four ERs is now (under-)staffed by private equity firms. This is leading to longer wait times, deterioration in patient care, and higher bills,” Dr. Wright continued. “Private equity takeover of medicine must be stopped. All such deals should be strictly regulated and should be heavily scrutinized, if not barred altogether. Our health depends upon it!”

The federal government is accepting public comments like Dr. Wright’s through June 5 and has even set up a website (healthycompetition.gov) to make it easier to file complaints against health organizations possibly violating antitrust laws.

The US Department of Justice’s Antitrust Division, the Federal Trade Commission (FTC), and the Department of Health and Human Services want to hear from physicians and the public about how private equity firms’ investments in healthcare entities, such as hospitals, nursing homes, or specialty service providers, affect patients and healthcare workers. The investigation will also evaluate how market pricing, competition, and referral patterns change when practices and hospitals are acquired by health systems or insurers.

Maintaining competition in the provider and payer markets benefits healthcare workers through higher pay, while patients can access quality care at lower prices, the joint request for information said. However, consolidation and mergers — potentially driven by private equity’s entry into the market — can diminish these benefits.

Investigating private equity and consolidation in medicine is part of the Biden Administration’s focus on lowering medical and prescription drug costs and strengthening competition in healthcare. The FTC’s vote last week to ban noncompete agreements, which business groups have vowed to challenge in court, falls under the same initiative.

Alexandra Nicole Thran, MD, FACEP, president of the Vermont Chapter of the American College of Emergency Physicians, said that the private equity business model is problematic because it ties physicians’ wages to patient satisfaction and the number of patients they see per hour. 

A Connecticut primary care physician expressed similar sentiments. “Physicians are being forced into a system where corporations provide financial incentives and punitive policies to direct healthcare decisions towards a profitable aim,” said Eric Schwaber, MD. 

While a majority of comments criticized the role of private equity and consolidation, some reflected a more positive view. 

“Private equity helps make healthcare more efficient and effective. It brings needed operational and managerial expertise to allow for better patient care,” said Reenie Abraham, MD, an associate professor in the Department of Internal Medicine at University of Texas Southwestern Medical Center, Dallas. The University of Texas is facing a lawsuit involving the liability status of its physicians who work for a private equity-backed hospital partly owned by the university.

Several public comments point to the increasing market influence UnitedHealth Group (UHG) and other payers have obtained through recent acquisitions. Retired emergency room physician Scott Davis, MD, said that the “astronomical” rate of burnout among providers has been exacerbated by “the economic takeover of the healthcare system by…United Healthcare [and] private equity groups who put profits over anything else.”  

The healthcare conglomerate employs approximately 10% of active US physicians, including many through its subsidiary, Optum Health, which provides primary, urgent, and surgical care. UHG has also invested heavily in acquiring physician practices to advance its value-based care model.

“If a publicly traded private insurance or private equity company is interested in their short-term quarterly profits or stock price, there is little interest in the…effective management of chronic disease, other than that which fulfills a ‘value-based’ metric,” wrote Kenneth Dolkart, MD, FACP, clinical assistant professor at the Dartmouth Geisel School of Medicine in Hanover, New Hampshire. 

Sarah Ealy, a revenue cycle professional, commented that payers like UHG have outsized bargaining power when negotiating rates with providers. “In many states, United Healthcare and its subsidiaries pay a lower reimbursement rate than state Medicaid plans — these rates are nearly 50% of the breakeven per-visit rate that practices need to keep the lights on.”

Another comment ties the recent cyberattack on UHG-owned Change Healthcare to private equity ownership and “healthcare behemoths buying up practices and data.”

“The ramrodding of consolidation and private oversight with little to no barriers to foreign intrusions…is a testament to how ill prepared [the] US market is to private equity healthcare takeovers,” said SW Dermatology Practice LLC. 

The agencies request comments from all health market participants, including physicians, nurses, employers, administrators, and patients.

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

Health-related social needs and medical financial hardship are associated with increased risk of mortality in adult cancer survivors, based on data from more than 10,000 individuals.

Little is known about the specific association between health-related social needs (HRSNs) and mortality risk even though HRSNs, defined as challenges in affording food, housing, and other necessities of daily living, are potential challenges for cancer survivors, wrote Zhiyuan Zheng, PhD, of the American Cancer Society, Atlanta, and colleagues.

A 2020 study by Dr. Zheng and colleagues published in the Journal of the National Comprehensive Cancer Network (NCCN) showed that food insecurity and financial worries had a negative impact on cancer survivorship. In the new study, published in Cancer, the researchers identified cancer survivors using the 2013-2018 National Health Interview Survey (NHIS) and the NHIS Mortality File through December 31, 2019. The researchers examined mortality using the data from the Centers for Disease Control and Prevention’s National Death Index (NDI) through December 31, 2019, which links to the National Health Interview Survey Data used in the study.

Individuals’ HRSNs were categorized into three groups: severe, moderate, and minor/none. HRSNs included food insecurity and nonmedical financial concerns, such as housing costs (rent, mortgage). Medical financial hardship included material, psychological, and behavioral domains and was divided into three groups: 2-3 domains, 1 domain, or 0 domains.
 

What Are the Potential Financial Implications of this Research?

The high costs of cancer care often cause medical financial hardships for cancer survivors, and expenses also may cause psychological distress and nonmedical financial hardship as survivors try to make ends meet while facing medical bills, wrote Dr. Zheng and colleagues.

Policy makers are increasingly interested in adding HRSNs to insurance coverage; recent guidance from the Centers for Medicare & Medicaid Services (CMS) allows individual states to apply to provide nutrition and housing supports through state Medicaid programs, according to authors of a 2023 article published in JAMA Health Forum.

The new study adds to the understanding of how HRSNs impact people with cancer by examining the association with mortality risk, Yelak Biru, MSc, president and chief executive officer of the International Myeloma Foundation, said in an interview.

“This is a key area of study for addressing the disparities in treatments and outcomes that result in inequities,” said Mr. Biru, a patient advocate and multiple myeloma survivor who was not involved in the study.
 

What Does the New Study Show?

The new study characterized HRSNs in 5,855 adult cancer survivors aged 18-64 years and 5,918 aged 65-79 years. In the 18- to 64-year-old group, 25.5% reported moderate levels of HRSNs, and 18.3% reported severe HRSNs. In patients aged 65-79 years, 15.6% and 6.6% reported moderate HRSNs and severe HRSNs, respectively.

Severe HRSN was significantly associated with higher mortality risk in an adjusted analysis in patients aged 18-64 years (hazard ratio 2.00, P < .001).

Among adults aged 65-79 years, severe HRSN was not associated with higher mortality risk; however, in this older age group, those with 2-3 domains of medical financial hardship had significantly increased mortality risk compared with adults aged 65-79 years with zero domains of medical financial hardship (HR 1.58, P = .007).

Although the findings that HRSNs were associated with increased mortality risk, especially in the younger group, were not surprising, they serve as a call to action to address how HRSNs are contributing to cancer mortality, Mr. Biru said in an interview. “HRSNs, like food or housing insecurity, can lead to patients being unable to undergo the best treatment approach for their cancer,” he said.
 

What Are the Limitations and Research Gaps?

The study findings were limited by several factors including the use of self-reports to measure medical financial hardship, food insecurity, and nonmedical financial concerns in the NHIS, the researchers wrote in their discussion. More research with longer follow-up time beyond 1-5 years is needed, wrote Dr. Zheng and colleagues.

Studies also are needed to illustrate how patient navigation can help prevent patients from falling through the cracks with regard to social needs and financial hardships, Mr. Biru told this news organization.

Other areas for research include how addressing social needs affects health outcomes and whether programs designed to address social needs are effective, he said.

“Finally, qualitative research is needed to capture the lived experiences of cancer survivors facing these challenges. This knowledge can inform the development of more patient-centered interventions and policies that effectively address the social determinants of health and improve overall outcomes for all cancer survivors,” Mr. Biru said.
 

What Is the Takeaway Message for Clinicians?

HRSNs and financial hardship are significantly associated with increased risk of mortality in adult cancer survivors, Dr. Zheng and colleagues concluded. Looking ahead, comprehensive assessment of HRSNs and financial hardship may help clinicians connect patients with relevant services to mitigate the social and financial impacts of cancer, they wrote.

“The takeaway message for oncologists in practice is that addressing [HRSNs] and financial hardship is crucial for providing comprehensive and equitable cancer care,” Mr. Biru said during his interview.

“The impact of social determinants of health on cancer outcomes cannot be ignored, and oncologists play a vital role in identifying and addressing these needs,” he said. Sensitive, discussion-based screenings are needed to identify core needs such as food and transportation, but clinicians also can consider broader social factors and work with a team to connect patients to appropriate resources, he added.

“By recognizing the importance of HRSN screening and taking proactive steps to address these needs, oncologists can contribute to improving health outcomes, reducing healthcare disparities, and providing more equitable cancer care for their patients,” he said.
 

What Other Guidance Is Available?

“High-quality cancer care requires treating the whole person; measuring and addressing anything in their life that could result in poorer health outcomes is a key component of comprehensive care,” Mr. Biru emphasized.

In September 2023, the National Comprehensive Cancer Network (NCCN) convened a working group cochaired by Mr. Biru that developed recommendations for how oncology practices should routinely measure HRSNs (NCCN.org/social-needs).

“The working group proposed that every cancer patient be assessed for food, transportation access, and financial and housing security at least once a year, and be reassessed at every care transition point as well,” Mr. Biru said. Such screenings should include follow-up to connect patients with services to address any HRSNs they are experiencing, he added.

Lead author Dr. Zheng is employed by the American Cancer Society, which as a nonprofit receives funds from the public through fundraising and contributions, as well as some support from corporations and industry to support its mission programs and services. Mr. Biru had no financial conflicts to disclose.

Health-related social needs and medical financial hardship are associated with increased risk of mortality in adult cancer survivors, based on data from more than 10,000 individuals.

Little is known about the specific association between health-related social needs (HRSNs) and mortality risk even though HRSNs, defined as challenges in affording food, housing, and other necessities of daily living, are potential challenges for cancer survivors, wrote Zhiyuan Zheng, PhD, of the American Cancer Society, Atlanta, and colleagues.

A 2020 study by Dr. Zheng and colleagues published in the Journal of the National Comprehensive Cancer Network (NCCN) showed that food insecurity and financial worries had a negative impact on cancer survivorship. In the new study, published in Cancer, the researchers identified cancer survivors using the 2013-2018 National Health Interview Survey (NHIS) and the NHIS Mortality File through December 31, 2019. The researchers examined mortality using the data from the Centers for Disease Control and Prevention’s National Death Index (NDI) through December 31, 2019, which links to the National Health Interview Survey Data used in the study.

Individuals’ HRSNs were categorized into three groups: severe, moderate, and minor/none. HRSNs included food insecurity and nonmedical financial concerns, such as housing costs (rent, mortgage). Medical financial hardship included material, psychological, and behavioral domains and was divided into three groups: 2-3 domains, 1 domain, or 0 domains.
 

What Are the Potential Financial Implications of this Research?

The high costs of cancer care often cause medical financial hardships for cancer survivors, and expenses also may cause psychological distress and nonmedical financial hardship as survivors try to make ends meet while facing medical bills, wrote Dr. Zheng and colleagues.

Policy makers are increasingly interested in adding HRSNs to insurance coverage; recent guidance from the Centers for Medicare & Medicaid Services (CMS) allows individual states to apply to provide nutrition and housing supports through state Medicaid programs, according to authors of a 2023 article published in JAMA Health Forum.

The new study adds to the understanding of how HRSNs impact people with cancer by examining the association with mortality risk, Yelak Biru, MSc, president and chief executive officer of the International Myeloma Foundation, said in an interview.

“This is a key area of study for addressing the disparities in treatments and outcomes that result in inequities,” said Mr. Biru, a patient advocate and multiple myeloma survivor who was not involved in the study.
 

What Does the New Study Show?

The new study characterized HRSNs in 5,855 adult cancer survivors aged 18-64 years and 5,918 aged 65-79 years. In the 18- to 64-year-old group, 25.5% reported moderate levels of HRSNs, and 18.3% reported severe HRSNs. In patients aged 65-79 years, 15.6% and 6.6% reported moderate HRSNs and severe HRSNs, respectively.

Severe HRSN was significantly associated with higher mortality risk in an adjusted analysis in patients aged 18-64 years (hazard ratio 2.00, P < .001).

Among adults aged 65-79 years, severe HRSN was not associated with higher mortality risk; however, in this older age group, those with 2-3 domains of medical financial hardship had significantly increased mortality risk compared with adults aged 65-79 years with zero domains of medical financial hardship (HR 1.58, P = .007).

Although the findings that HRSNs were associated with increased mortality risk, especially in the younger group, were not surprising, they serve as a call to action to address how HRSNs are contributing to cancer mortality, Mr. Biru said in an interview. “HRSNs, like food or housing insecurity, can lead to patients being unable to undergo the best treatment approach for their cancer,” he said.
 

What Are the Limitations and Research Gaps?

The study findings were limited by several factors including the use of self-reports to measure medical financial hardship, food insecurity, and nonmedical financial concerns in the NHIS, the researchers wrote in their discussion. More research with longer follow-up time beyond 1-5 years is needed, wrote Dr. Zheng and colleagues.

Studies also are needed to illustrate how patient navigation can help prevent patients from falling through the cracks with regard to social needs and financial hardships, Mr. Biru told this news organization.

Other areas for research include how addressing social needs affects health outcomes and whether programs designed to address social needs are effective, he said.

“Finally, qualitative research is needed to capture the lived experiences of cancer survivors facing these challenges. This knowledge can inform the development of more patient-centered interventions and policies that effectively address the social determinants of health and improve overall outcomes for all cancer survivors,” Mr. Biru said.
 

What Is the Takeaway Message for Clinicians?

HRSNs and financial hardship are significantly associated with increased risk of mortality in adult cancer survivors, Dr. Zheng and colleagues concluded. Looking ahead, comprehensive assessment of HRSNs and financial hardship may help clinicians connect patients with relevant services to mitigate the social and financial impacts of cancer, they wrote.

“The takeaway message for oncologists in practice is that addressing [HRSNs] and financial hardship is crucial for providing comprehensive and equitable cancer care,” Mr. Biru said during his interview.

“The impact of social determinants of health on cancer outcomes cannot be ignored, and oncologists play a vital role in identifying and addressing these needs,” he said. Sensitive, discussion-based screenings are needed to identify core needs such as food and transportation, but clinicians also can consider broader social factors and work with a team to connect patients to appropriate resources, he added.

“By recognizing the importance of HRSN screening and taking proactive steps to address these needs, oncologists can contribute to improving health outcomes, reducing healthcare disparities, and providing more equitable cancer care for their patients,” he said.
 

What Other Guidance Is Available?

“High-quality cancer care requires treating the whole person; measuring and addressing anything in their life that could result in poorer health outcomes is a key component of comprehensive care,” Mr. Biru emphasized.

In September 2023, the National Comprehensive Cancer Network (NCCN) convened a working group cochaired by Mr. Biru that developed recommendations for how oncology practices should routinely measure HRSNs (NCCN.org/social-needs).

“The working group proposed that every cancer patient be assessed for food, transportation access, and financial and housing security at least once a year, and be reassessed at every care transition point as well,” Mr. Biru said. Such screenings should include follow-up to connect patients with services to address any HRSNs they are experiencing, he added.

Lead author Dr. Zheng is employed by the American Cancer Society, which as a nonprofit receives funds from the public through fundraising and contributions, as well as some support from corporations and industry to support its mission programs and services. Mr. Biru had no financial conflicts to disclose.

Health-related social needs and medical financial hardship are associated with increased risk of mortality in adult cancer survivors, based on data from more than 10,000 individuals.

Little is known about the specific association between health-related social needs (HRSNs) and mortality risk even though HRSNs, defined as challenges in affording food, housing, and other necessities of daily living, are potential challenges for cancer survivors, wrote Zhiyuan Zheng, PhD, of the American Cancer Society, Atlanta, and colleagues.

A 2020 study by Dr. Zheng and colleagues published in the Journal of the National Comprehensive Cancer Network (NCCN) showed that food insecurity and financial worries had a negative impact on cancer survivorship. In the new study, published in Cancer, the researchers identified cancer survivors using the 2013-2018 National Health Interview Survey (NHIS) and the NHIS Mortality File through December 31, 2019. The researchers examined mortality using the data from the Centers for Disease Control and Prevention’s National Death Index (NDI) through December 31, 2019, which links to the National Health Interview Survey Data used in the study.

Individuals’ HRSNs were categorized into three groups: severe, moderate, and minor/none. HRSNs included food insecurity and nonmedical financial concerns, such as housing costs (rent, mortgage). Medical financial hardship included material, psychological, and behavioral domains and was divided into three groups: 2-3 domains, 1 domain, or 0 domains.
 

What Are the Potential Financial Implications of this Research?

The high costs of cancer care often cause medical financial hardships for cancer survivors, and expenses also may cause psychological distress and nonmedical financial hardship as survivors try to make ends meet while facing medical bills, wrote Dr. Zheng and colleagues.

Policy makers are increasingly interested in adding HRSNs to insurance coverage; recent guidance from the Centers for Medicare & Medicaid Services (CMS) allows individual states to apply to provide nutrition and housing supports through state Medicaid programs, according to authors of a 2023 article published in JAMA Health Forum.

The new study adds to the understanding of how HRSNs impact people with cancer by examining the association with mortality risk, Yelak Biru, MSc, president and chief executive officer of the International Myeloma Foundation, said in an interview.

“This is a key area of study for addressing the disparities in treatments and outcomes that result in inequities,” said Mr. Biru, a patient advocate and multiple myeloma survivor who was not involved in the study.
 

What Does the New Study Show?

The new study characterized HRSNs in 5,855 adult cancer survivors aged 18-64 years and 5,918 aged 65-79 years. In the 18- to 64-year-old group, 25.5% reported moderate levels of HRSNs, and 18.3% reported severe HRSNs. In patients aged 65-79 years, 15.6% and 6.6% reported moderate HRSNs and severe HRSNs, respectively.

Severe HRSN was significantly associated with higher mortality risk in an adjusted analysis in patients aged 18-64 years (hazard ratio 2.00, P < .001).

Among adults aged 65-79 years, severe HRSN was not associated with higher mortality risk; however, in this older age group, those with 2-3 domains of medical financial hardship had significantly increased mortality risk compared with adults aged 65-79 years with zero domains of medical financial hardship (HR 1.58, P = .007).

Although the findings that HRSNs were associated with increased mortality risk, especially in the younger group, were not surprising, they serve as a call to action to address how HRSNs are contributing to cancer mortality, Mr. Biru said in an interview. “HRSNs, like food or housing insecurity, can lead to patients being unable to undergo the best treatment approach for their cancer,” he said.
 

What Are the Limitations and Research Gaps?

The study findings were limited by several factors including the use of self-reports to measure medical financial hardship, food insecurity, and nonmedical financial concerns in the NHIS, the researchers wrote in their discussion. More research with longer follow-up time beyond 1-5 years is needed, wrote Dr. Zheng and colleagues.

Studies also are needed to illustrate how patient navigation can help prevent patients from falling through the cracks with regard to social needs and financial hardships, Mr. Biru told this news organization.

Other areas for research include how addressing social needs affects health outcomes and whether programs designed to address social needs are effective, he said.

“Finally, qualitative research is needed to capture the lived experiences of cancer survivors facing these challenges. This knowledge can inform the development of more patient-centered interventions and policies that effectively address the social determinants of health and improve overall outcomes for all cancer survivors,” Mr. Biru said.
 

What Is the Takeaway Message for Clinicians?

HRSNs and financial hardship are significantly associated with increased risk of mortality in adult cancer survivors, Dr. Zheng and colleagues concluded. Looking ahead, comprehensive assessment of HRSNs and financial hardship may help clinicians connect patients with relevant services to mitigate the social and financial impacts of cancer, they wrote.

“The takeaway message for oncologists in practice is that addressing [HRSNs] and financial hardship is crucial for providing comprehensive and equitable cancer care,” Mr. Biru said during his interview.

“The impact of social determinants of health on cancer outcomes cannot be ignored, and oncologists play a vital role in identifying and addressing these needs,” he said. Sensitive, discussion-based screenings are needed to identify core needs such as food and transportation, but clinicians also can consider broader social factors and work with a team to connect patients to appropriate resources, he added.

“By recognizing the importance of HRSN screening and taking proactive steps to address these needs, oncologists can contribute to improving health outcomes, reducing healthcare disparities, and providing more equitable cancer care for their patients,” he said.
 

What Other Guidance Is Available?

“High-quality cancer care requires treating the whole person; measuring and addressing anything in their life that could result in poorer health outcomes is a key component of comprehensive care,” Mr. Biru emphasized.

In September 2023, the National Comprehensive Cancer Network (NCCN) convened a working group cochaired by Mr. Biru that developed recommendations for how oncology practices should routinely measure HRSNs (NCCN.org/social-needs).

“The working group proposed that every cancer patient be assessed for food, transportation access, and financial and housing security at least once a year, and be reassessed at every care transition point as well,” Mr. Biru said. Such screenings should include follow-up to connect patients with services to address any HRSNs they are experiencing, he added.

Lead author Dr. Zheng is employed by the American Cancer Society, which as a nonprofit receives funds from the public through fundraising and contributions, as well as some support from corporations and industry to support its mission programs and services. Mr. Biru had no financial conflicts to disclose.

In 2020, the American Cancer Society (ACS) updated its cervical screening guidelines, proposing two major changes: start cervical cancer screening at age 25, rather than 21, and perform primary human papillomavirus (HPV) testing, instead of a Pap test. 

But a recent survey, published earlier this year, found that few clinicians are following these ACS recommendations. And the reasons are multifaceted.

First, healthcare providers in the US may be unsure how to reconcile conflicting cervical cancer screening guidelines from another major organization — the US Preventive Services Task Force (USPSTF), which published guidelines in 2018. 

Although the ACS guidelines are based on an analysis of the latest evidence, 

the recommendations challenge those from the USPSTF, which dictates insurance coverage in the US. Last year, the American College of Obstetricians and Gynecologists (ACOG) aligned its guidelines with those from the USPSTF.

The USPSTF recommends average-risk individuals start Pap, not HPV, testing at age 21, and broadens the options to primary HPV testing, Pap testing, or both together starting at age 30. The ACS, on the other hand, says primary HPV testing is the preferred screening approach from the start, which should be age 25. 

Because the ACS guidelines marked a notable departure from prevailing practice, a team of researchers from five US universities decided to find out if anyone was following them. 

The results, published in the journal Cancer in March, revealed that most healthcare providers had not changed practice.

Lead author Rebecca Perkins, MD, MSc, and colleagues found that, among the 70 respondents, few were starting screening at age 25, and none had switched to primary HPV testing. 

The survey then probed clinicians’ willingness to adopt the ACS guidelines as well as their reservations and barriers to doing so. 

Notably, more than half of the survey participants said they would be willing to adopt the ACS guidelines if the best evidence supported the changes and other professional medical organizations endorsed them.

On the age change, participants highlighted a range of benefits to moving to a later screening age, including that earlier screening may not be valuable and delaying screening could reduce overtreatment. 

One participant noted: “We know that cervical cancer is usually a slow‐growing, long‐term progressive disease that does not typically show up that early in life, and we also know that, if infected, oftentimes their immune system can fight off the virus. So, it sounds reasonable at first glance [to delay screening to age 25 years].” 

Others, however, brought up barriers to initiating screening at age 25. Some mentioned that later screening may not work for high‐risk populations and others voiced concerns about missing high‐grade precancer or cancer. “It’s not unusual for us to see women in their early 20s that have already had 10 or 15 partners. … a lot of them smoke too … they just have a lot of bad habits that put them at more risk,” one respondent noted.

On the HPV vs Pap testing front, many participants described a growing confidence in HPV tests after trying co-testing. One participant said, “Honestly, I do look more at the HPV results than the cytology. I put more faith in knowing what their HPV status is than anything.” 

The main barriers to primary HPV testing, however, included lack of autonomy when working in a large health system, concerns about the efficacy of HPV testing, and a belief that cytology was valuable.

Some clinicians were worried about missing high-grade lesions or cancer. One healthcare provider said, “My only concern with primary HPV screening is occasionally you will pick up endometrial abnormalities on a Pap that you’re not going to pick up with HPV screening.”

Logistics and finances also played a role in clinicians’ hesitancy to switch to the ACS recommendation. Labs that could handle primary HPV tests were not available to some participants, and lack of insurance coverage was a barrier for others. One respondent noted, for instance, that his institution has a “cytology infrastructure that already exists in the lab and I can’t really see them switching.” 

Many survey respondents also said they were waiting for endorsement from organizations, such as ACOG and USPSTF. “We run by the USPSTF and … ACOG. We don’t run by the ACS guidelines,” one person said. 

Finally, some participants were not aware of the ACS recommendations at all or the data behind them but said they would be willing to change to primary HPV testing in the future. 

Overall, Dr. Perkins said she was happy to see that more than half of the respondents would be willing to shift to the ACS screening guidelines, but noted that many remain reluctant to do so until the USPSTF and ACOG change their guidelines. 

“It’s really just a matter of the USPSTF and ACOG endorsing” the ACS guidelines, said Dr. Perkins, professor of obstetrics and gynecology at Boston University. 

The USPSTF is currently updating its cervical screening guidelines, which could potentially help reconcile this discord between the guidelines and close the gaps in practice patterns. 

The USPSTF’s review of the evidence, which led to the 2018 guidelines, did highlight the effectiveness of HPV testing. The review authors concluded that “the evidence was consistent across trials” that primary, high-risk HPV screening increased detection of grade 3 or worse cervical intraepithelial neoplasia in the initial round of screening “by as much as 2 to 3 times when compared with cytology.”

However, Joy Melnikow, MD, MPH, first author on the USPSTF evidence review, explained that the reviewers factored in access to HPV testing when making their final recommendations.

“The consideration was making sure that a recommendation could be inclusive of all providers and all populations and not restricting access for clinics that couldn’t afford or didn’t have the machine to do [HPV testing],” Dr. Melnikow, director of the Center for Healthcare Policy and Research and professor of family and community medicine at the University of California Davis, told this news organization.

The ACS, however, did not consider potential access problems in its analysis of the evidence.

Although the ACS evidence is “excellent,” Dr. Perkins said, “it’s really just a matter of the USPSTF and ACOG endorsing that, and then it seems like a lot of people are willing to make the change.”

Dr. Perkins reports no relevant financial relationships.

A version of this article appeared on Medscape.com.

In 2020, the American Cancer Society (ACS) updated its cervical screening guidelines, proposing two major changes: start cervical cancer screening at age 25, rather than 21, and perform primary human papillomavirus (HPV) testing, instead of a Pap test. 

But a recent survey, published earlier this year, found that few clinicians are following these ACS recommendations. And the reasons are multifaceted.

First, healthcare providers in the US may be unsure how to reconcile conflicting cervical cancer screening guidelines from another major organization — the US Preventive Services Task Force (USPSTF), which published guidelines in 2018. 

Although the ACS guidelines are based on an analysis of the latest evidence, 

the recommendations challenge those from the USPSTF, which dictates insurance coverage in the US. Last year, the American College of Obstetricians and Gynecologists (ACOG) aligned its guidelines with those from the USPSTF.

The USPSTF recommends average-risk individuals start Pap, not HPV, testing at age 21, and broadens the options to primary HPV testing, Pap testing, or both together starting at age 30. The ACS, on the other hand, says primary HPV testing is the preferred screening approach from the start, which should be age 25. 

Because the ACS guidelines marked a notable departure from prevailing practice, a team of researchers from five US universities decided to find out if anyone was following them. 

The results, published in the journal Cancer in March, revealed that most healthcare providers had not changed practice.

Lead author Rebecca Perkins, MD, MSc, and colleagues found that, among the 70 respondents, few were starting screening at age 25, and none had switched to primary HPV testing. 

The survey then probed clinicians’ willingness to adopt the ACS guidelines as well as their reservations and barriers to doing so. 

Notably, more than half of the survey participants said they would be willing to adopt the ACS guidelines if the best evidence supported the changes and other professional medical organizations endorsed them.

On the age change, participants highlighted a range of benefits to moving to a later screening age, including that earlier screening may not be valuable and delaying screening could reduce overtreatment. 

One participant noted: “We know that cervical cancer is usually a slow‐growing, long‐term progressive disease that does not typically show up that early in life, and we also know that, if infected, oftentimes their immune system can fight off the virus. So, it sounds reasonable at first glance [to delay screening to age 25 years].” 

Others, however, brought up barriers to initiating screening at age 25. Some mentioned that later screening may not work for high‐risk populations and others voiced concerns about missing high‐grade precancer or cancer. “It’s not unusual for us to see women in their early 20s that have already had 10 or 15 partners. … a lot of them smoke too … they just have a lot of bad habits that put them at more risk,” one respondent noted.

On the HPV vs Pap testing front, many participants described a growing confidence in HPV tests after trying co-testing. One participant said, “Honestly, I do look more at the HPV results than the cytology. I put more faith in knowing what their HPV status is than anything.” 

The main barriers to primary HPV testing, however, included lack of autonomy when working in a large health system, concerns about the efficacy of HPV testing, and a belief that cytology was valuable.

Some clinicians were worried about missing high-grade lesions or cancer. One healthcare provider said, “My only concern with primary HPV screening is occasionally you will pick up endometrial abnormalities on a Pap that you’re not going to pick up with HPV screening.”

Logistics and finances also played a role in clinicians’ hesitancy to switch to the ACS recommendation. Labs that could handle primary HPV tests were not available to some participants, and lack of insurance coverage was a barrier for others. One respondent noted, for instance, that his institution has a “cytology infrastructure that already exists in the lab and I can’t really see them switching.” 

Many survey respondents also said they were waiting for endorsement from organizations, such as ACOG and USPSTF. “We run by the USPSTF and … ACOG. We don’t run by the ACS guidelines,” one person said. 

Finally, some participants were not aware of the ACS recommendations at all or the data behind them but said they would be willing to change to primary HPV testing in the future. 

Overall, Dr. Perkins said she was happy to see that more than half of the respondents would be willing to shift to the ACS screening guidelines, but noted that many remain reluctant to do so until the USPSTF and ACOG change their guidelines. 

“It’s really just a matter of the USPSTF and ACOG endorsing” the ACS guidelines, said Dr. Perkins, professor of obstetrics and gynecology at Boston University. 

The USPSTF is currently updating its cervical screening guidelines, which could potentially help reconcile this discord between the guidelines and close the gaps in practice patterns. 

The USPSTF’s review of the evidence, which led to the 2018 guidelines, did highlight the effectiveness of HPV testing. The review authors concluded that “the evidence was consistent across trials” that primary, high-risk HPV screening increased detection of grade 3 or worse cervical intraepithelial neoplasia in the initial round of screening “by as much as 2 to 3 times when compared with cytology.”

However, Joy Melnikow, MD, MPH, first author on the USPSTF evidence review, explained that the reviewers factored in access to HPV testing when making their final recommendations.

“The consideration was making sure that a recommendation could be inclusive of all providers and all populations and not restricting access for clinics that couldn’t afford or didn’t have the machine to do [HPV testing],” Dr. Melnikow, director of the Center for Healthcare Policy and Research and professor of family and community medicine at the University of California Davis, told this news organization.

The ACS, however, did not consider potential access problems in its analysis of the evidence.

Although the ACS evidence is “excellent,” Dr. Perkins said, “it’s really just a matter of the USPSTF and ACOG endorsing that, and then it seems like a lot of people are willing to make the change.”

Dr. Perkins reports no relevant financial relationships.

A version of this article appeared on Medscape.com.

In 2020, the American Cancer Society (ACS) updated its cervical screening guidelines, proposing two major changes: start cervical cancer screening at age 25, rather than 21, and perform primary human papillomavirus (HPV) testing, instead of a Pap test. 

But a recent survey, published earlier this year, found that few clinicians are following these ACS recommendations. And the reasons are multifaceted.

First, healthcare providers in the US may be unsure how to reconcile conflicting cervical cancer screening guidelines from another major organization — the US Preventive Services Task Force (USPSTF), which published guidelines in 2018. 

Although the ACS guidelines are based on an analysis of the latest evidence, 

the recommendations challenge those from the USPSTF, which dictates insurance coverage in the US. Last year, the American College of Obstetricians and Gynecologists (ACOG) aligned its guidelines with those from the USPSTF.

The USPSTF recommends average-risk individuals start Pap, not HPV, testing at age 21, and broadens the options to primary HPV testing, Pap testing, or both together starting at age 30. The ACS, on the other hand, says primary HPV testing is the preferred screening approach from the start, which should be age 25. 

Because the ACS guidelines marked a notable departure from prevailing practice, a team of researchers from five US universities decided to find out if anyone was following them. 

The results, published in the journal Cancer in March, revealed that most healthcare providers had not changed practice.

Lead author Rebecca Perkins, MD, MSc, and colleagues found that, among the 70 respondents, few were starting screening at age 25, and none had switched to primary HPV testing. 

The survey then probed clinicians’ willingness to adopt the ACS guidelines as well as their reservations and barriers to doing so. 

Notably, more than half of the survey participants said they would be willing to adopt the ACS guidelines if the best evidence supported the changes and other professional medical organizations endorsed them.

On the age change, participants highlighted a range of benefits to moving to a later screening age, including that earlier screening may not be valuable and delaying screening could reduce overtreatment. 

One participant noted: “We know that cervical cancer is usually a slow‐growing, long‐term progressive disease that does not typically show up that early in life, and we also know that, if infected, oftentimes their immune system can fight off the virus. So, it sounds reasonable at first glance [to delay screening to age 25 years].” 

Others, however, brought up barriers to initiating screening at age 25. Some mentioned that later screening may not work for high‐risk populations and others voiced concerns about missing high‐grade precancer or cancer. “It’s not unusual for us to see women in their early 20s that have already had 10 or 15 partners. … a lot of them smoke too … they just have a lot of bad habits that put them at more risk,” one respondent noted.

On the HPV vs Pap testing front, many participants described a growing confidence in HPV tests after trying co-testing. One participant said, “Honestly, I do look more at the HPV results than the cytology. I put more faith in knowing what their HPV status is than anything.” 

The main barriers to primary HPV testing, however, included lack of autonomy when working in a large health system, concerns about the efficacy of HPV testing, and a belief that cytology was valuable.

Some clinicians were worried about missing high-grade lesions or cancer. One healthcare provider said, “My only concern with primary HPV screening is occasionally you will pick up endometrial abnormalities on a Pap that you’re not going to pick up with HPV screening.”

Logistics and finances also played a role in clinicians’ hesitancy to switch to the ACS recommendation. Labs that could handle primary HPV tests were not available to some participants, and lack of insurance coverage was a barrier for others. One respondent noted, for instance, that his institution has a “cytology infrastructure that already exists in the lab and I can’t really see them switching.” 

Many survey respondents also said they were waiting for endorsement from organizations, such as ACOG and USPSTF. “We run by the USPSTF and … ACOG. We don’t run by the ACS guidelines,” one person said. 

Finally, some participants were not aware of the ACS recommendations at all or the data behind them but said they would be willing to change to primary HPV testing in the future. 

Overall, Dr. Perkins said she was happy to see that more than half of the respondents would be willing to shift to the ACS screening guidelines, but noted that many remain reluctant to do so until the USPSTF and ACOG change their guidelines. 

“It’s really just a matter of the USPSTF and ACOG endorsing” the ACS guidelines, said Dr. Perkins, professor of obstetrics and gynecology at Boston University. 

The USPSTF is currently updating its cervical screening guidelines, which could potentially help reconcile this discord between the guidelines and close the gaps in practice patterns. 

The USPSTF’s review of the evidence, which led to the 2018 guidelines, did highlight the effectiveness of HPV testing. The review authors concluded that “the evidence was consistent across trials” that primary, high-risk HPV screening increased detection of grade 3 or worse cervical intraepithelial neoplasia in the initial round of screening “by as much as 2 to 3 times when compared with cytology.”

However, Joy Melnikow, MD, MPH, first author on the USPSTF evidence review, explained that the reviewers factored in access to HPV testing when making their final recommendations.

“The consideration was making sure that a recommendation could be inclusive of all providers and all populations and not restricting access for clinics that couldn’t afford or didn’t have the machine to do [HPV testing],” Dr. Melnikow, director of the Center for Healthcare Policy and Research and professor of family and community medicine at the University of California Davis, told this news organization.

The ACS, however, did not consider potential access problems in its analysis of the evidence.

Although the ACS evidence is “excellent,” Dr. Perkins said, “it’s really just a matter of the USPSTF and ACOG endorsing that, and then it seems like a lot of people are willing to make the change.”

Dr. Perkins reports no relevant financial relationships.

A version of this article appeared on Medscape.com.

SAN DIEGO — British investigators have demonstrated a “potentially curative” neoadjuvant regimen for early-stage germline BRCA 1/2–mutated breast cancer.

In a small trial, 39 patients randomized to the regimen — a combination of standard chemotherapy with the poly(ADP-ribose)polymerase (PARP) inhibitor olaparib — were alive at 3 years vs 39 of 45 (87%) randomized to chemotherapy alone.

“A remarkable 100% of patients were still alive at 36 months, which is a significant landmark for these patients,” said chief investigator Jean Abraham, PhD, a breast oncologist at the University of Cambridge, England, who presented the findings at the American Association for Cancer Research annual meeting.

It’s a “small but very powerful signal” of “what could be a potentially curative regimen that definitely does need to be confirmed in a larger study,” Dr. Abraham added.

The study, a part of the PARTNER trial, included 84 patients with T1-2 tumors of any hormone status. Just over 70% in both arms had BRCA 1 mutations, and the rest had BRCA 2 mutations.

Past attempts at combining chemotherapy with PARP inhibitors have been hampered by excess bone marrow toxicity. To counter the problem, patients randomized to the combination therapy received olaparib 48 hours after carboplatin to give their bone marrow a chance to recover.

The median age was 38 years in the control group and 47 years in the olaparib arm. A greater proportion of patients in the control arm (42% vs 23%) had axillary node involvement.

Overall, patients received neoadjuvant carboplatin on day 1 and paclitaxel on days 1, 8, and 15 every 3 weeks for four cycles, followed by anthracycline every 3 weeks for three cycles. In the study arm, olaparib 150 mg was administered twice daily starting on day 3 continuing to day 14 during the first four cycles. Almost 90% of patients received at least 80% of their planned olaparib dose.

Despite the delay in olaparib dosing, 56.4% of patients in the combination arm required a transfusion vs 48.9% with chemotherapy alone.

At a median follow-up of 40.7 months, 96% of patients in the combination arm demonstrated event-free survival, with one patient relapsing, vs 80% in the chemotherapy-alone group, with nine patients relapsing.

In the final analysis, 64% of patients who received olaparib had a pathological complete response compared with almost 70% in the chemotherapy group, though the difference was not statistically significant.

The trial was stopped short at 50% enrollment after the data monitoring safety committee determined that olaparib add-on was unlikely to improve pathological complete response rates, the trial’s primary endpoint.

However, pathological complete response rates did not appear to affect overall survival.

“It didn’t seem to matter whether you had a non-pathological complete response, you still survived 100%” with the combination, Dr. Abraham said, adding that this is not the first study to show a disconnect between response rates and survival.

Perhaps, this disconnect could be due to “doomed cells” that look like residual disease but are, in fact, dying and unable to metastasize, she said.

No patients in the combination arm and two in the control arm received olaparib, immunotherapy, or capecitabine after surgery. Both control participants relapsed, and one died.

Toxicity was more severe for patients in the combination arm. More patients who received olaparib (76.9%) experienced a grade 3 or worse adverse event vs 60% of patients in the control arm.

Study discussant Hope S. Rugo, MD, a breast oncologist at the University of California San Francisco, highlighted a few limitations and remaining questions.

First, “this is a very small population, so small differences in the biology of the tumor, the patients, and even stage that we can’t assess in the neoadjuvant setting could make a difference that would affect event-free and overall survival,” she said.

Second, two patients with pathological complete responses relapsed in the control arm and died, “which is quite unusual,” Dr. Rugo said. “Patients who achieve a pathological complete response generally have an excellent outcome.”

Dr. Rugo noted that “gap sequencing doesn’t appear to avoid the toxicity of PARP inhibitors.”

However, she said, “the efficacy results are intriguing” and would need confirmation in a larger randomized trial, perhaps with newer, more selective PARP inhibitors.

The work was funded by AstraZeneca, maker of olaparib. Researchers included AstraZeneca employees. Dr. Abraham is an adviser to and disclosed grants, travel costs, and honoraria from the company. Dr. Rugo disclosed research funding from AstraZeneca and other companies.

A version of this article appeared on Medscape.com.

SAN DIEGO — British investigators have demonstrated a “potentially curative” neoadjuvant regimen for early-stage germline BRCA 1/2–mutated breast cancer.

In a small trial, 39 patients randomized to the regimen — a combination of standard chemotherapy with the poly(ADP-ribose)polymerase (PARP) inhibitor olaparib — were alive at 3 years vs 39 of 45 (87%) randomized to chemotherapy alone.

“A remarkable 100% of patients were still alive at 36 months, which is a significant landmark for these patients,” said chief investigator Jean Abraham, PhD, a breast oncologist at the University of Cambridge, England, who presented the findings at the American Association for Cancer Research annual meeting.

It’s a “small but very powerful signal” of “what could be a potentially curative regimen that definitely does need to be confirmed in a larger study,” Dr. Abraham added.

The study, a part of the PARTNER trial, included 84 patients with T1-2 tumors of any hormone status. Just over 70% in both arms had BRCA 1 mutations, and the rest had BRCA 2 mutations.

Past attempts at combining chemotherapy with PARP inhibitors have been hampered by excess bone marrow toxicity. To counter the problem, patients randomized to the combination therapy received olaparib 48 hours after carboplatin to give their bone marrow a chance to recover.

The median age was 38 years in the control group and 47 years in the olaparib arm. A greater proportion of patients in the control arm (42% vs 23%) had axillary node involvement.

Overall, patients received neoadjuvant carboplatin on day 1 and paclitaxel on days 1, 8, and 15 every 3 weeks for four cycles, followed by anthracycline every 3 weeks for three cycles. In the study arm, olaparib 150 mg was administered twice daily starting on day 3 continuing to day 14 during the first four cycles. Almost 90% of patients received at least 80% of their planned olaparib dose.

Despite the delay in olaparib dosing, 56.4% of patients in the combination arm required a transfusion vs 48.9% with chemotherapy alone.

At a median follow-up of 40.7 months, 96% of patients in the combination arm demonstrated event-free survival, with one patient relapsing, vs 80% in the chemotherapy-alone group, with nine patients relapsing.

In the final analysis, 64% of patients who received olaparib had a pathological complete response compared with almost 70% in the chemotherapy group, though the difference was not statistically significant.

The trial was stopped short at 50% enrollment after the data monitoring safety committee determined that olaparib add-on was unlikely to improve pathological complete response rates, the trial’s primary endpoint.

However, pathological complete response rates did not appear to affect overall survival.

“It didn’t seem to matter whether you had a non-pathological complete response, you still survived 100%” with the combination, Dr. Abraham said, adding that this is not the first study to show a disconnect between response rates and survival.

Perhaps, this disconnect could be due to “doomed cells” that look like residual disease but are, in fact, dying and unable to metastasize, she said.

No patients in the combination arm and two in the control arm received olaparib, immunotherapy, or capecitabine after surgery. Both control participants relapsed, and one died.

Toxicity was more severe for patients in the combination arm. More patients who received olaparib (76.9%) experienced a grade 3 or worse adverse event vs 60% of patients in the control arm.

Study discussant Hope S. Rugo, MD, a breast oncologist at the University of California San Francisco, highlighted a few limitations and remaining questions.

First, “this is a very small population, so small differences in the biology of the tumor, the patients, and even stage that we can’t assess in the neoadjuvant setting could make a difference that would affect event-free and overall survival,” she said.

Second, two patients with pathological complete responses relapsed in the control arm and died, “which is quite unusual,” Dr. Rugo said. “Patients who achieve a pathological complete response generally have an excellent outcome.”

Dr. Rugo noted that “gap sequencing doesn’t appear to avoid the toxicity of PARP inhibitors.”

However, she said, “the efficacy results are intriguing” and would need confirmation in a larger randomized trial, perhaps with newer, more selective PARP inhibitors.

The work was funded by AstraZeneca, maker of olaparib. Researchers included AstraZeneca employees. Dr. Abraham is an adviser to and disclosed grants, travel costs, and honoraria from the company. Dr. Rugo disclosed research funding from AstraZeneca and other companies.

A version of this article appeared on Medscape.com.

SAN DIEGO — British investigators have demonstrated a “potentially curative” neoadjuvant regimen for early-stage germline BRCA 1/2–mutated breast cancer.

In a small trial, 39 patients randomized to the regimen — a combination of standard chemotherapy with the poly(ADP-ribose)polymerase (PARP) inhibitor olaparib — were alive at 3 years vs 39 of 45 (87%) randomized to chemotherapy alone.

“A remarkable 100% of patients were still alive at 36 months, which is a significant landmark for these patients,” said chief investigator Jean Abraham, PhD, a breast oncologist at the University of Cambridge, England, who presented the findings at the American Association for Cancer Research annual meeting.

It’s a “small but very powerful signal” of “what could be a potentially curative regimen that definitely does need to be confirmed in a larger study,” Dr. Abraham added.

The study, a part of the PARTNER trial, included 84 patients with T1-2 tumors of any hormone status. Just over 70% in both arms had BRCA 1 mutations, and the rest had BRCA 2 mutations.

Past attempts at combining chemotherapy with PARP inhibitors have been hampered by excess bone marrow toxicity. To counter the problem, patients randomized to the combination therapy received olaparib 48 hours after carboplatin to give their bone marrow a chance to recover.

The median age was 38 years in the control group and 47 years in the olaparib arm. A greater proportion of patients in the control arm (42% vs 23%) had axillary node involvement.

Overall, patients received neoadjuvant carboplatin on day 1 and paclitaxel on days 1, 8, and 15 every 3 weeks for four cycles, followed by anthracycline every 3 weeks for three cycles. In the study arm, olaparib 150 mg was administered twice daily starting on day 3 continuing to day 14 during the first four cycles. Almost 90% of patients received at least 80% of their planned olaparib dose.

Despite the delay in olaparib dosing, 56.4% of patients in the combination arm required a transfusion vs 48.9% with chemotherapy alone.

At a median follow-up of 40.7 months, 96% of patients in the combination arm demonstrated event-free survival, with one patient relapsing, vs 80% in the chemotherapy-alone group, with nine patients relapsing.

In the final analysis, 64% of patients who received olaparib had a pathological complete response compared with almost 70% in the chemotherapy group, though the difference was not statistically significant.

The trial was stopped short at 50% enrollment after the data monitoring safety committee determined that olaparib add-on was unlikely to improve pathological complete response rates, the trial’s primary endpoint.

However, pathological complete response rates did not appear to affect overall survival.

“It didn’t seem to matter whether you had a non-pathological complete response, you still survived 100%” with the combination, Dr. Abraham said, adding that this is not the first study to show a disconnect between response rates and survival.

Perhaps, this disconnect could be due to “doomed cells” that look like residual disease but are, in fact, dying and unable to metastasize, she said.

No patients in the combination arm and two in the control arm received olaparib, immunotherapy, or capecitabine after surgery. Both control participants relapsed, and one died.

Toxicity was more severe for patients in the combination arm. More patients who received olaparib (76.9%) experienced a grade 3 or worse adverse event vs 60% of patients in the control arm.

Study discussant Hope S. Rugo, MD, a breast oncologist at the University of California San Francisco, highlighted a few limitations and remaining questions.

First, “this is a very small population, so small differences in the biology of the tumor, the patients, and even stage that we can’t assess in the neoadjuvant setting could make a difference that would affect event-free and overall survival,” she said.

Second, two patients with pathological complete responses relapsed in the control arm and died, “which is quite unusual,” Dr. Rugo said. “Patients who achieve a pathological complete response generally have an excellent outcome.”

Dr. Rugo noted that “gap sequencing doesn’t appear to avoid the toxicity of PARP inhibitors.”

However, she said, “the efficacy results are intriguing” and would need confirmation in a larger randomized trial, perhaps with newer, more selective PARP inhibitors.

The work was funded by AstraZeneca, maker of olaparib. Researchers included AstraZeneca employees. Dr. Abraham is an adviser to and disclosed grants, travel costs, and honoraria from the company. Dr. Rugo disclosed research funding from AstraZeneca and other companies.

A version of this article appeared on Medscape.com.

Insane hours and work-driven burnout are increasingly pernicious forces in medical workplaces. They apparently also are helping steer more physicians toward locum tenens, or temporary, assignments.

In its “2024 Survey of Locum Tenens Physicians and Advanced Practice Professionals,” Coppell, Texas–based staffing firm AMN Healthcare asked doctors, nurse practitioners, and physician assistants why they chose locum tenens work.

Morsa Images/DigitalVision/Getty Images

The reason chosen most often is improving work hours. Eighty-six percent of respondents said that was the “most important” or a “moderately important” factor. Next was addressing work burnout (80% of respondents), followed by unhappiness with compensation (75%), and dissatisfaction with being a full-time employee (71%).

“During the COVID pandemic, healthcare professionals began to rethink how, when, and where they work,” said Jeff Decker, president of AMN Healthcare’s physician solutions division, adding that he estimates about 52,000 US physicians now work on a locum tenens basis.

“Locum tenens offers relief from the long, inflexible work hours and onerous bureaucratic duties that often cause dissatisfaction and burnout among physicians and other healthcare providers.”

These feelings of dissatisfaction dovetail with findings in recent reports by this news organization based on surveys of physicians about burnout and employment. For example:

• Forty-nine percent of physicians acknowledged feeling burned out, up from 42% 6 years earlier.
• Eighty-three percent of doctors attributed their burnout and/or depression to the job entirely or most of the time.
• Flexibility in work schedules was one of the improvements chosen most often as a potential aid to burnout.
• The leading reasons cited for burnout were the number of bureaucratic tasks and too many hours at work.

Trying Locum Tenens Early in Career

According to AMN Healthcare, 81% of the physicians and APPs in its latest survey said they started taking locum tenens assignments immediately after finishing medical training or in mid-career. Only 19% waited until after retiring from medicine compared with 36% in AMN Healthcare’s 2016 survey.

In the 2024 report, a strong plurality of respondents (47%) said they found locum tenens work more satisfying than permanent healthcare employment. Twelve percent said the opposite, and 30% found the choices about equal.

Even so, it doesn’t appear that locum tenens represents a permanent career path for many. About as many (45%) of physicians and APPs said they would return to full-time employment if progress were made with conditions like hours and burnout, as said they would not (43%).

“Many physicians and other healthcare professionals feel they are being pushed from permanent positions by unsatisfactory work conditions,” Mr. Decker said. “To get them back, employers should offer practice conditions that appeal to today’s providers.”

A version of this article appeared on Medscape.com.

Insane hours and work-driven burnout are increasingly pernicious forces in medical workplaces. They apparently also are helping steer more physicians toward locum tenens, or temporary, assignments.

In its “2024 Survey of Locum Tenens Physicians and Advanced Practice Professionals,” Coppell, Texas–based staffing firm AMN Healthcare asked doctors, nurse practitioners, and physician assistants why they chose locum tenens work.

Morsa Images/DigitalVision/Getty Images

The reason chosen most often is improving work hours. Eighty-six percent of respondents said that was the “most important” or a “moderately important” factor. Next was addressing work burnout (80% of respondents), followed by unhappiness with compensation (75%), and dissatisfaction with being a full-time employee (71%).

“During the COVID pandemic, healthcare professionals began to rethink how, when, and where they work,” said Jeff Decker, president of AMN Healthcare’s physician solutions division, adding that he estimates about 52,000 US physicians now work on a locum tenens basis.

“Locum tenens offers relief from the long, inflexible work hours and onerous bureaucratic duties that often cause dissatisfaction and burnout among physicians and other healthcare providers.”

These feelings of dissatisfaction dovetail with findings in recent reports by this news organization based on surveys of physicians about burnout and employment. For example:

• Forty-nine percent of physicians acknowledged feeling burned out, up from 42% 6 years earlier.
• Eighty-three percent of doctors attributed their burnout and/or depression to the job entirely or most of the time.
• Flexibility in work schedules was one of the improvements chosen most often as a potential aid to burnout.
• The leading reasons cited for burnout were the number of bureaucratic tasks and too many hours at work.

Trying Locum Tenens Early in Career

According to AMN Healthcare, 81% of the physicians and APPs in its latest survey said they started taking locum tenens assignments immediately after finishing medical training or in mid-career. Only 19% waited until after retiring from medicine compared with 36% in AMN Healthcare’s 2016 survey.

In the 2024 report, a strong plurality of respondents (47%) said they found locum tenens work more satisfying than permanent healthcare employment. Twelve percent said the opposite, and 30% found the choices about equal.

Even so, it doesn’t appear that locum tenens represents a permanent career path for many. About as many (45%) of physicians and APPs said they would return to full-time employment if progress were made with conditions like hours and burnout, as said they would not (43%).

“Many physicians and other healthcare professionals feel they are being pushed from permanent positions by unsatisfactory work conditions,” Mr. Decker said. “To get them back, employers should offer practice conditions that appeal to today’s providers.”

A version of this article appeared on Medscape.com.

Insane hours and work-driven burnout are increasingly pernicious forces in medical workplaces. They apparently also are helping steer more physicians toward locum tenens, or temporary, assignments.

In its “2024 Survey of Locum Tenens Physicians and Advanced Practice Professionals,” Coppell, Texas–based staffing firm AMN Healthcare asked doctors, nurse practitioners, and physician assistants why they chose locum tenens work.

Morsa Images/DigitalVision/Getty Images

The reason chosen most often is improving work hours. Eighty-six percent of respondents said that was the “most important” or a “moderately important” factor. Next was addressing work burnout (80% of respondents), followed by unhappiness with compensation (75%), and dissatisfaction with being a full-time employee (71%).

“During the COVID pandemic, healthcare professionals began to rethink how, when, and where they work,” said Jeff Decker, president of AMN Healthcare’s physician solutions division, adding that he estimates about 52,000 US physicians now work on a locum tenens basis.

“Locum tenens offers relief from the long, inflexible work hours and onerous bureaucratic duties that often cause dissatisfaction and burnout among physicians and other healthcare providers.”

These feelings of dissatisfaction dovetail with findings in recent reports by this news organization based on surveys of physicians about burnout and employment. For example:

• Forty-nine percent of physicians acknowledged feeling burned out, up from 42% 6 years earlier.
• Eighty-three percent of doctors attributed their burnout and/or depression to the job entirely or most of the time.
• Flexibility in work schedules was one of the improvements chosen most often as a potential aid to burnout.
• The leading reasons cited for burnout were the number of bureaucratic tasks and too many hours at work.

Trying Locum Tenens Early in Career

According to AMN Healthcare, 81% of the physicians and APPs in its latest survey said they started taking locum tenens assignments immediately after finishing medical training or in mid-career. Only 19% waited until after retiring from medicine compared with 36% in AMN Healthcare’s 2016 survey.

In the 2024 report, a strong plurality of respondents (47%) said they found locum tenens work more satisfying than permanent healthcare employment. Twelve percent said the opposite, and 30% found the choices about equal.

Even so, it doesn’t appear that locum tenens represents a permanent career path for many. About as many (45%) of physicians and APPs said they would return to full-time employment if progress were made with conditions like hours and burnout, as said they would not (43%).

“Many physicians and other healthcare professionals feel they are being pushed from permanent positions by unsatisfactory work conditions,” Mr. Decker said. “To get them back, employers should offer practice conditions that appeal to today’s providers.”

A version of this article appeared on Medscape.com.

Urinary tract infections are among the most common bacterial infections. They can be painful, require antibiotic treatments, and recur in 20%-30% of cases. With the risk for the emergence or increase of resistance to antibiotics, it is important to search for potential therapeutic alternatives to treat or prevent urinary tract infections.

The MV140 Vaccine

The MV140 vaccine is produced by the Spanish pharmaceutical company Immunotek. MV140, known as Uromune, consists of a suspension of whole heat-inactivated bacteria in glycerol, sodium chloride, an artificial pineapple flavor, and water. It includes equal percentages of strains from four bacterial species (V121 Escherichia coli, V113 Klebsiella pneumoniae, V125 Enterococcus faecalis, and V127 Proteus vulgaris). MV140 is administered sublingually by spraying two 100-µL doses daily for 3 months.

The vaccine is in phase 2-3 of development. It is available under special access programs outside of marketing authorization in 26 countries, including Spain, Portugal, the United Kingdom, Lithuania, the Netherlands, Sweden, Norway, Australia, New Zealand, and Chile. Recently, MV140 was approved in Mexico and the Dominican Republic and submitted to Health Canada for registration.

A randomized study published in 2022 showed the vaccine›s efficacy in preventing urinary tract infections over 9 months. In total, 240 women with a urinary tract infection received MV140 for either 3 or 6 months or a placebo for 6 months. The primary outcome was the number of urinary tract infection episodes during the 9-month study period after vaccination.

In this pivotal study, MV140 administration for 3 and 6 months was associated with a significant reduction in the median number of urinary tract infection episodes, from 3.0 to 0.0 compared with the placebo during the 9-month efficacy period. The median time to the first urinary tract infection after 3 months of treatment was 275.0 days in the MV140 groups compared with 48.0 days in the placebo group.

Nine-Year Follow-Up

On April 6 at the 2024 congress of The European Association of Urology, urologists from the Royal Berkshire NHS Foundation Trust presented the results of a study evaluating the MV140 vaccine spray for long-term prevention of bacterial urinary tract infections.

This was a prospective cohort study involving 89 participants (72 women and 17 men) older than 18 years with recurrent urinary tract infections who received a course of MV140 for 3 months. Participants had no urinary tract infection when offered the vaccine and had no other urinary abnormalities (such as tumors, stones, or kidney infections).

Postvaccination follow-up was conducted over a 9-year period, during which researchers analyzed the data from the electronic health records of their initial cohort. They queried participants about the occurrence of urinary tract infections since receiving the vaccine and about potential related side effects. Thus, the results were self-reported.

Long-Term Efficacy 

In this cohort, 48 participants (59%) reported having no infections during the 9-year follow-up. In the cohort of 89 participants, the average period without infection was 54.7 months (4.5 years; 56.7 months for women and 44.3 months for men). No vaccine-related side effects were observed.

The study’s limitations included the small number of participants and the collection of self-reported data. Furthermore, all cases were simple urinary tract infections without complications.

The authors concluded that “9 years after first receiving the sublingual spray MV140 vaccine, 54% of participants remained free from urinary tract infection.” For them, “this vaccine is safe in the long-term, and our participants reported fewer urinary tract infections and, if any, they were less severe.”

Vaccination could thus be an alternative to antibiotic treatments and could help combat the emergence of antibiotic resistance. The full study results should be published by the end of 2024.

Other studies are planned to evaluate the efficacy and safety of the MV140 vaccine in older patients residing in long-term care homes, in children suffering from acute urinary tract infections, and in adults suffering from complicated acute urinary tract infections (for example, patients with a catheter or with a neurogenic bladder). 
 

This story was translated from JIM, which is part of the Medscape Professional Network, 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.

Urinary tract infections are among the most common bacterial infections. They can be painful, require antibiotic treatments, and recur in 20%-30% of cases. With the risk for the emergence or increase of resistance to antibiotics, it is important to search for potential therapeutic alternatives to treat or prevent urinary tract infections.

The MV140 Vaccine

The MV140 vaccine is produced by the Spanish pharmaceutical company Immunotek. MV140, known as Uromune, consists of a suspension of whole heat-inactivated bacteria in glycerol, sodium chloride, an artificial pineapple flavor, and water. It includes equal percentages of strains from four bacterial species (V121 Escherichia coli, V113 Klebsiella pneumoniae, V125 Enterococcus faecalis, and V127 Proteus vulgaris). MV140 is administered sublingually by spraying two 100-µL doses daily for 3 months.

The vaccine is in phase 2-3 of development. It is available under special access programs outside of marketing authorization in 26 countries, including Spain, Portugal, the United Kingdom, Lithuania, the Netherlands, Sweden, Norway, Australia, New Zealand, and Chile. Recently, MV140 was approved in Mexico and the Dominican Republic and submitted to Health Canada for registration.

A randomized study published in 2022 showed the vaccine›s efficacy in preventing urinary tract infections over 9 months. In total, 240 women with a urinary tract infection received MV140 for either 3 or 6 months or a placebo for 6 months. The primary outcome was the number of urinary tract infection episodes during the 9-month study period after vaccination.

In this pivotal study, MV140 administration for 3 and 6 months was associated with a significant reduction in the median number of urinary tract infection episodes, from 3.0 to 0.0 compared with the placebo during the 9-month efficacy period. The median time to the first urinary tract infection after 3 months of treatment was 275.0 days in the MV140 groups compared with 48.0 days in the placebo group.

Nine-Year Follow-Up

On April 6 at the 2024 congress of The European Association of Urology, urologists from the Royal Berkshire NHS Foundation Trust presented the results of a study evaluating the MV140 vaccine spray for long-term prevention of bacterial urinary tract infections.

This was a prospective cohort study involving 89 participants (72 women and 17 men) older than 18 years with recurrent urinary tract infections who received a course of MV140 for 3 months. Participants had no urinary tract infection when offered the vaccine and had no other urinary abnormalities (such as tumors, stones, or kidney infections).

Postvaccination follow-up was conducted over a 9-year period, during which researchers analyzed the data from the electronic health records of their initial cohort. They queried participants about the occurrence of urinary tract infections since receiving the vaccine and about potential related side effects. Thus, the results were self-reported.

Long-Term Efficacy 

In this cohort, 48 participants (59%) reported having no infections during the 9-year follow-up. In the cohort of 89 participants, the average period without infection was 54.7 months (4.5 years; 56.7 months for women and 44.3 months for men). No vaccine-related side effects were observed.

The study’s limitations included the small number of participants and the collection of self-reported data. Furthermore, all cases were simple urinary tract infections without complications.

The authors concluded that “9 years after first receiving the sublingual spray MV140 vaccine, 54% of participants remained free from urinary tract infection.” For them, “this vaccine is safe in the long-term, and our participants reported fewer urinary tract infections and, if any, they were less severe.”

Vaccination could thus be an alternative to antibiotic treatments and could help combat the emergence of antibiotic resistance. The full study results should be published by the end of 2024.

Other studies are planned to evaluate the efficacy and safety of the MV140 vaccine in older patients residing in long-term care homes, in children suffering from acute urinary tract infections, and in adults suffering from complicated acute urinary tract infections (for example, patients with a catheter or with a neurogenic bladder). 
 

This story was translated from JIM, which is part of the Medscape Professional Network, 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.

Urinary tract infections are among the most common bacterial infections. They can be painful, require antibiotic treatments, and recur in 20%-30% of cases. With the risk for the emergence or increase of resistance to antibiotics, it is important to search for potential therapeutic alternatives to treat or prevent urinary tract infections.

The MV140 Vaccine

The MV140 vaccine is produced by the Spanish pharmaceutical company Immunotek. MV140, known as Uromune, consists of a suspension of whole heat-inactivated bacteria in glycerol, sodium chloride, an artificial pineapple flavor, and water. It includes equal percentages of strains from four bacterial species (V121 Escherichia coli, V113 Klebsiella pneumoniae, V125 Enterococcus faecalis, and V127 Proteus vulgaris). MV140 is administered sublingually by spraying two 100-µL doses daily for 3 months.

The vaccine is in phase 2-3 of development. It is available under special access programs outside of marketing authorization in 26 countries, including Spain, Portugal, the United Kingdom, Lithuania, the Netherlands, Sweden, Norway, Australia, New Zealand, and Chile. Recently, MV140 was approved in Mexico and the Dominican Republic and submitted to Health Canada for registration.

A randomized study published in 2022 showed the vaccine›s efficacy in preventing urinary tract infections over 9 months. In total, 240 women with a urinary tract infection received MV140 for either 3 or 6 months or a placebo for 6 months. The primary outcome was the number of urinary tract infection episodes during the 9-month study period after vaccination.

In this pivotal study, MV140 administration for 3 and 6 months was associated with a significant reduction in the median number of urinary tract infection episodes, from 3.0 to 0.0 compared with the placebo during the 9-month efficacy period. The median time to the first urinary tract infection after 3 months of treatment was 275.0 days in the MV140 groups compared with 48.0 days in the placebo group.

Nine-Year Follow-Up

On April 6 at the 2024 congress of The European Association of Urology, urologists from the Royal Berkshire NHS Foundation Trust presented the results of a study evaluating the MV140 vaccine spray for long-term prevention of bacterial urinary tract infections.

This was a prospective cohort study involving 89 participants (72 women and 17 men) older than 18 years with recurrent urinary tract infections who received a course of MV140 for 3 months. Participants had no urinary tract infection when offered the vaccine and had no other urinary abnormalities (such as tumors, stones, or kidney infections).

Postvaccination follow-up was conducted over a 9-year period, during which researchers analyzed the data from the electronic health records of their initial cohort. They queried participants about the occurrence of urinary tract infections since receiving the vaccine and about potential related side effects. Thus, the results were self-reported.

Long-Term Efficacy 

In this cohort, 48 participants (59%) reported having no infections during the 9-year follow-up. In the cohort of 89 participants, the average period without infection was 54.7 months (4.5 years; 56.7 months for women and 44.3 months for men). No vaccine-related side effects were observed.

The study’s limitations included the small number of participants and the collection of self-reported data. Furthermore, all cases were simple urinary tract infections without complications.

The authors concluded that “9 years after first receiving the sublingual spray MV140 vaccine, 54% of participants remained free from urinary tract infection.” For them, “this vaccine is safe in the long-term, and our participants reported fewer urinary tract infections and, if any, they were less severe.”

Vaccination could thus be an alternative to antibiotic treatments and could help combat the emergence of antibiotic resistance. The full study results should be published by the end of 2024.

Other studies are planned to evaluate the efficacy and safety of the MV140 vaccine in older patients residing in long-term care homes, in children suffering from acute urinary tract infections, and in adults suffering from complicated acute urinary tract infections (for example, patients with a catheter or with a neurogenic bladder). 
 

This story was translated from JIM, which is part of the Medscape Professional Network, 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.

Medical innovations don’t happen overnight — but in today’s digital world, they happen pretty fast. Some are advancing faster than you think.

We’re not talking theory or hoped-for breakthroughs in the next decade. These technologies are already a reality for many doctors and expected to grow rapidly in the next 1-3 years.

Are you ready? Let’s find out.

1. Artificial Intelligence (AI) Medical Scribes

You may already be using this or, at the very least, have heard about it.

Physician burnout is a growing problem, with many doctors spending 2 hours on paperwork for every hour with patients. But some doctors, such as Gregory Ator, MD, chief medical informatics officer at the University of Kansas Medical Center, Kansas City, Kansas, have found a better way.

“I have been using it for 9 months now, and it truly is a life changer,” Dr. Ator said of Abridge, an AI helper that transcribes and summarizes his conversations with patients. “Now, I go into the room, place my phone just about anywhere, and I can just listen.” He estimated that the tech saves him between 3 and 10 minutes per patient. “At 20 patients a day, that saves me around 2 hours,” he said.

Bonus: Patients “get a doctor’s full attention instead of just looking at the top of his head while they play with the computer,” Dr. Ator said. “I have yet to have a patient who didn’t think that was a positive thing.”

Several companies are already selling these AI devices, including Ambience Healthcare, Augmedix, Nuance, and Suki, and they offer more than just transcriptions, said John D. Halamka, MD, president of Mayo Clinic Platform, who oversees Mayo’s adoption of AI. They also generate notes for treatment and billing and update data in the electronic health record.

“It’s preparation of documentation based on ambient listening of doctor-patient conversations,” Dr. Halamka explained. “I’m very optimistic about the use of emerging AI technologies to enable every clinician to practice at the top of their license.”

Patricia Garcia, MD, associate clinical information officer for ambulatory care at Stanford Health Care, has spent much of the last year co-running the medical center’s pilot program for AI scribes, and she’s so impressed with the technology that she “expects it’ll become more widely available as an option for any clinician that wants to use it in the next 12-18 months.”

2. Three-Dimensional (3D) Printing

Although 3D-printed organs may not happen anytime soon, the future is here for some 3D-printed prosthetics and implants — everything from dentures to spinal implants to prosthetic fingers and noses.

“In the next few years, I see rapid growth in the use of 3D printing technology across orthopedic surgery,” said Rishin J. Kadakia, MD, an orthopedic surgeon in Atlanta. “It’s becoming more common not just at large academic institutions. More and more providers will turn to using 3D printing technology to help tackle challenging cases that previously did not have good solutions.”

Dr. Kadakia has experienced this firsthand with his patients at the Emory Orthopaedics & Spine Center. One female patient developed talar avascular necrosis due to a bone break she’d sustained in a serious car crash. An ankle and subtalar joint fusion would repair the damage but limit her mobility and change her gait. So instead, in August of 2021, Dr. Kadakia and fellow orthopedic surgeon Jason Bariteau, MD, created for her a 3D-printed cobalt chrome talus implant.

“It provided an opportunity for her to keep her ankle’s range of motion, and also mobilize faster than with a subtalar and ankle joint fusion,” said Dr. Kadakia.

The technology is also playing a role in customized medical devices — patient-specific tools for greater precision — and 3D-printed anatomical models, built to the exact specifications of individual patients. Mayo Clinic already has 3D modeling units in three states, and other hospitals are following suit. The models not only help doctors prepare for complicated surgeries but also can dramatically cut down on costs. A 2021 study from Durham University reported that 3D models helped reduce surgery time by between 1.5 and 2.5 hours in lengthy procedures.

3. Drones

For patients who can’t make it to a pharmacy to pick up their prescriptions, either because of distance or lack of transportation, drones — which can deliver medications onto a customer’s back yard or front porch — offer a compelling solution.

Several companies and hospitals are already experimenting with drones, like WellSpan Health in Pennsylvania, Amazon Pharmacy, and the Cleveland Clinic, which announced a partnership with drone delivery company Zipline and plans to begin prescription deliveries across Northeast Ohio by 2025.

Healthcare systems are just beginning to explore the potential of drone deliveries, for everything from lab samples to medical and surgical supplies — even defibrillators that could arrive at an ailing patient’s front door before an emergency medical technician arrives.

“For many providers, when you take a sample from a patient, that sample waits around for hours until a courier picks up all of the facility’s samples and drives them to an outside facility for processing,” said Hillary Brendzel, head of Zipline’s US Healthcare Practice.

According to a 2022 survey from American Nurse Journal, 71% of nurses said that medical courier delays and errors negatively affected their ability to provide patient care. But with drone delivery, “lab samples can be sent for processing immediately, on-demand, resulting in faster diagnosis, treatment, and ultimately better outcomes,” said Ms. Brendzel.

4. Portable Ultrasound

Within the next 2 years, portable ultrasound — pocket-sized devices that connect to a smartphone or tablet — will become the “21st-century stethoscope,” said Abhilash Hareendranathan, PhD, assistant professor in the Department of Radiology and Diagnostic Imaging at the University of Alberta, in Edmonton, Alberta, Canada.

AI can make these devices easy to use, allowing clinicians with minimal imaging training to capture clear images and understand the results. Dr. Hareendranathan developed the Ultrasound Arm Injury Detection tool, a portable ultrasound that uses AI to detect fracture.

“We plan to introduce this technology in emergency departments, where it could be used by triage nurses to perform quick examinations to detect fractures of the wrist, elbow, or shoulder,” he said.

More pocket-sized scanners like these could “reshape the way diagnostic care is provided in rural and remote communities,” Dr. Hareendranathan said, and will “reduce wait times in crowded emergency departments.” Bill Gates believes enough in portable ultrasound that last September, the Bill & Melinda Gates Foundation granted $44 million to GE HealthCare to develop the technology for under-resourced communities.

5. Virtual Reality (VR)

When RelieVRx became the first US Food and Drug Administration (FDA)–approved VR therapy for chronic back pain in 2021, the technology was used in just a handful of Veterans Affairs (VA) facilities. But today, thousands of VR headsets have been deployed to more than 160 VA medical centers and clinics across the country.

“The VR experiences encompass pain neuroscience education, mindfulness, pleasant and relaxing distraction, and key skills to calm the nervous system,” said Beth Darnall, PhD, director of the Stanford Pain Relief Innovations Lab, who helped design the RelieVRx. She expects VR to go mainstream soon, not just because of increasing evidence that it works but also thanks to the Centers for Medicare & Medicaid Services, which recently issued a Healthcare Common Procedure Coding System code for VR. “This billing infrastructure will encourage adoption and uptake,” she said.

Hundreds of hospitals across the United States have already adopted the technology, for everything from childbirth pain to wound debridement, said Josh Sackman, the president and cofounder of AppliedVR, the company that developed RelieVRx.

“Over the next few years, we may see hundreds more deploy unique applications [for VR] that can handle multiple clinical indications,” he said. “Given the modality’s ability to scale and reduce reliance on pharmacological interventions, it has the power to improve the cost and quality of care.”

Hospital systems like Geisinger and Cedars-Sinai are already finding unique ways to implement the technology, he said, like using VR to reduce “scanxiety” during imaging service.

Other VR innovations are already being introduced, from the Smileyscope, a VR device for children that’s been proven to lessen the pain of a blood draw or intravenous insertion (it was cleared by the FDA last November) to several VR platforms launched by Cedars-Sinai in recent months, for applications that range from gastrointestinal issues to mental health therapy. “There may already be a thousand hospitals using VR in some capacity,” said Brennan Spiegel, MD, director of Health Services Research at Cedars-Sinai.

A version of this article appeared on Medscape.com.

Medical innovations don’t happen overnight — but in today’s digital world, they happen pretty fast. Some are advancing faster than you think.

We’re not talking theory or hoped-for breakthroughs in the next decade. These technologies are already a reality for many doctors and expected to grow rapidly in the next 1-3 years.

Are you ready? Let’s find out.

1. Artificial Intelligence (AI) Medical Scribes

You may already be using this or, at the very least, have heard about it.

Physician burnout is a growing problem, with many doctors spending 2 hours on paperwork for every hour with patients. But some doctors, such as Gregory Ator, MD, chief medical informatics officer at the University of Kansas Medical Center, Kansas City, Kansas, have found a better way.

“I have been using it for 9 months now, and it truly is a life changer,” Dr. Ator said of Abridge, an AI helper that transcribes and summarizes his conversations with patients. “Now, I go into the room, place my phone just about anywhere, and I can just listen.” He estimated that the tech saves him between 3 and 10 minutes per patient. “At 20 patients a day, that saves me around 2 hours,” he said.

Bonus: Patients “get a doctor’s full attention instead of just looking at the top of his head while they play with the computer,” Dr. Ator said. “I have yet to have a patient who didn’t think that was a positive thing.”

Several companies are already selling these AI devices, including Ambience Healthcare, Augmedix, Nuance, and Suki, and they offer more than just transcriptions, said John D. Halamka, MD, president of Mayo Clinic Platform, who oversees Mayo’s adoption of AI. They also generate notes for treatment and billing and update data in the electronic health record.

“It’s preparation of documentation based on ambient listening of doctor-patient conversations,” Dr. Halamka explained. “I’m very optimistic about the use of emerging AI technologies to enable every clinician to practice at the top of their license.”

Patricia Garcia, MD, associate clinical information officer for ambulatory care at Stanford Health Care, has spent much of the last year co-running the medical center’s pilot program for AI scribes, and she’s so impressed with the technology that she “expects it’ll become more widely available as an option for any clinician that wants to use it in the next 12-18 months.”

2. Three-Dimensional (3D) Printing

Although 3D-printed organs may not happen anytime soon, the future is here for some 3D-printed prosthetics and implants — everything from dentures to spinal implants to prosthetic fingers and noses.

“In the next few years, I see rapid growth in the use of 3D printing technology across orthopedic surgery,” said Rishin J. Kadakia, MD, an orthopedic surgeon in Atlanta. “It’s becoming more common not just at large academic institutions. More and more providers will turn to using 3D printing technology to help tackle challenging cases that previously did not have good solutions.”

Dr. Kadakia has experienced this firsthand with his patients at the Emory Orthopaedics & Spine Center. One female patient developed talar avascular necrosis due to a bone break she’d sustained in a serious car crash. An ankle and subtalar joint fusion would repair the damage but limit her mobility and change her gait. So instead, in August of 2021, Dr. Kadakia and fellow orthopedic surgeon Jason Bariteau, MD, created for her a 3D-printed cobalt chrome talus implant.

“It provided an opportunity for her to keep her ankle’s range of motion, and also mobilize faster than with a subtalar and ankle joint fusion,” said Dr. Kadakia.

The technology is also playing a role in customized medical devices — patient-specific tools for greater precision — and 3D-printed anatomical models, built to the exact specifications of individual patients. Mayo Clinic already has 3D modeling units in three states, and other hospitals are following suit. The models not only help doctors prepare for complicated surgeries but also can dramatically cut down on costs. A 2021 study from Durham University reported that 3D models helped reduce surgery time by between 1.5 and 2.5 hours in lengthy procedures.

3. Drones

For patients who can’t make it to a pharmacy to pick up their prescriptions, either because of distance or lack of transportation, drones — which can deliver medications onto a customer’s back yard or front porch — offer a compelling solution.

Several companies and hospitals are already experimenting with drones, like WellSpan Health in Pennsylvania, Amazon Pharmacy, and the Cleveland Clinic, which announced a partnership with drone delivery company Zipline and plans to begin prescription deliveries across Northeast Ohio by 2025.

Healthcare systems are just beginning to explore the potential of drone deliveries, for everything from lab samples to medical and surgical supplies — even defibrillators that could arrive at an ailing patient’s front door before an emergency medical technician arrives.

“For many providers, when you take a sample from a patient, that sample waits around for hours until a courier picks up all of the facility’s samples and drives them to an outside facility for processing,” said Hillary Brendzel, head of Zipline’s US Healthcare Practice.

According to a 2022 survey from American Nurse Journal, 71% of nurses said that medical courier delays and errors negatively affected their ability to provide patient care. But with drone delivery, “lab samples can be sent for processing immediately, on-demand, resulting in faster diagnosis, treatment, and ultimately better outcomes,” said Ms. Brendzel.

4. Portable Ultrasound

Within the next 2 years, portable ultrasound — pocket-sized devices that connect to a smartphone or tablet — will become the “21st-century stethoscope,” said Abhilash Hareendranathan, PhD, assistant professor in the Department of Radiology and Diagnostic Imaging at the University of Alberta, in Edmonton, Alberta, Canada.

AI can make these devices easy to use, allowing clinicians with minimal imaging training to capture clear images and understand the results. Dr. Hareendranathan developed the Ultrasound Arm Injury Detection tool, a portable ultrasound that uses AI to detect fracture.

“We plan to introduce this technology in emergency departments, where it could be used by triage nurses to perform quick examinations to detect fractures of the wrist, elbow, or shoulder,” he said.

More pocket-sized scanners like these could “reshape the way diagnostic care is provided in rural and remote communities,” Dr. Hareendranathan said, and will “reduce wait times in crowded emergency departments.” Bill Gates believes enough in portable ultrasound that last September, the Bill & Melinda Gates Foundation granted $44 million to GE HealthCare to develop the technology for under-resourced communities.

5. Virtual Reality (VR)

When RelieVRx became the first US Food and Drug Administration (FDA)–approved VR therapy for chronic back pain in 2021, the technology was used in just a handful of Veterans Affairs (VA) facilities. But today, thousands of VR headsets have been deployed to more than 160 VA medical centers and clinics across the country.

“The VR experiences encompass pain neuroscience education, mindfulness, pleasant and relaxing distraction, and key skills to calm the nervous system,” said Beth Darnall, PhD, director of the Stanford Pain Relief Innovations Lab, who helped design the RelieVRx. She expects VR to go mainstream soon, not just because of increasing evidence that it works but also thanks to the Centers for Medicare & Medicaid Services, which recently issued a Healthcare Common Procedure Coding System code for VR. “This billing infrastructure will encourage adoption and uptake,” she said.

Hundreds of hospitals across the United States have already adopted the technology, for everything from childbirth pain to wound debridement, said Josh Sackman, the president and cofounder of AppliedVR, the company that developed RelieVRx.

“Over the next few years, we may see hundreds more deploy unique applications [for VR] that can handle multiple clinical indications,” he said. “Given the modality’s ability to scale and reduce reliance on pharmacological interventions, it has the power to improve the cost and quality of care.”

Hospital systems like Geisinger and Cedars-Sinai are already finding unique ways to implement the technology, he said, like using VR to reduce “scanxiety” during imaging service.

Other VR innovations are already being introduced, from the Smileyscope, a VR device for children that’s been proven to lessen the pain of a blood draw or intravenous insertion (it was cleared by the FDA last November) to several VR platforms launched by Cedars-Sinai in recent months, for applications that range from gastrointestinal issues to mental health therapy. “There may already be a thousand hospitals using VR in some capacity,” said Brennan Spiegel, MD, director of Health Services Research at Cedars-Sinai.

A version of this article appeared on Medscape.com.

Medical innovations don’t happen overnight — but in today’s digital world, they happen pretty fast. Some are advancing faster than you think.

We’re not talking theory or hoped-for breakthroughs in the next decade. These technologies are already a reality for many doctors and expected to grow rapidly in the next 1-3 years.

Are you ready? Let’s find out.

1. Artificial Intelligence (AI) Medical Scribes

You may already be using this or, at the very least, have heard about it.

Physician burnout is a growing problem, with many doctors spending 2 hours on paperwork for every hour with patients. But some doctors, such as Gregory Ator, MD, chief medical informatics officer at the University of Kansas Medical Center, Kansas City, Kansas, have found a better way.

“I have been using it for 9 months now, and it truly is a life changer,” Dr. Ator said of Abridge, an AI helper that transcribes and summarizes his conversations with patients. “Now, I go into the room, place my phone just about anywhere, and I can just listen.” He estimated that the tech saves him between 3 and 10 minutes per patient. “At 20 patients a day, that saves me around 2 hours,” he said.

Bonus: Patients “get a doctor’s full attention instead of just looking at the top of his head while they play with the computer,” Dr. Ator said. “I have yet to have a patient who didn’t think that was a positive thing.”

Several companies are already selling these AI devices, including Ambience Healthcare, Augmedix, Nuance, and Suki, and they offer more than just transcriptions, said John D. Halamka, MD, president of Mayo Clinic Platform, who oversees Mayo’s adoption of AI. They also generate notes for treatment and billing and update data in the electronic health record.

“It’s preparation of documentation based on ambient listening of doctor-patient conversations,” Dr. Halamka explained. “I’m very optimistic about the use of emerging AI technologies to enable every clinician to practice at the top of their license.”

Patricia Garcia, MD, associate clinical information officer for ambulatory care at Stanford Health Care, has spent much of the last year co-running the medical center’s pilot program for AI scribes, and she’s so impressed with the technology that she “expects it’ll become more widely available as an option for any clinician that wants to use it in the next 12-18 months.”

2. Three-Dimensional (3D) Printing

Although 3D-printed organs may not happen anytime soon, the future is here for some 3D-printed prosthetics and implants — everything from dentures to spinal implants to prosthetic fingers and noses.

“In the next few years, I see rapid growth in the use of 3D printing technology across orthopedic surgery,” said Rishin J. Kadakia, MD, an orthopedic surgeon in Atlanta. “It’s becoming more common not just at large academic institutions. More and more providers will turn to using 3D printing technology to help tackle challenging cases that previously did not have good solutions.”

Dr. Kadakia has experienced this firsthand with his patients at the Emory Orthopaedics & Spine Center. One female patient developed talar avascular necrosis due to a bone break she’d sustained in a serious car crash. An ankle and subtalar joint fusion would repair the damage but limit her mobility and change her gait. So instead, in August of 2021, Dr. Kadakia and fellow orthopedic surgeon Jason Bariteau, MD, created for her a 3D-printed cobalt chrome talus implant.

“It provided an opportunity for her to keep her ankle’s range of motion, and also mobilize faster than with a subtalar and ankle joint fusion,” said Dr. Kadakia.

The technology is also playing a role in customized medical devices — patient-specific tools for greater precision — and 3D-printed anatomical models, built to the exact specifications of individual patients. Mayo Clinic already has 3D modeling units in three states, and other hospitals are following suit. The models not only help doctors prepare for complicated surgeries but also can dramatically cut down on costs. A 2021 study from Durham University reported that 3D models helped reduce surgery time by between 1.5 and 2.5 hours in lengthy procedures.

3. Drones

For patients who can’t make it to a pharmacy to pick up their prescriptions, either because of distance or lack of transportation, drones — which can deliver medications onto a customer’s back yard or front porch — offer a compelling solution.

Several companies and hospitals are already experimenting with drones, like WellSpan Health in Pennsylvania, Amazon Pharmacy, and the Cleveland Clinic, which announced a partnership with drone delivery company Zipline and plans to begin prescription deliveries across Northeast Ohio by 2025.

Healthcare systems are just beginning to explore the potential of drone deliveries, for everything from lab samples to medical and surgical supplies — even defibrillators that could arrive at an ailing patient’s front door before an emergency medical technician arrives.

“For many providers, when you take a sample from a patient, that sample waits around for hours until a courier picks up all of the facility’s samples and drives them to an outside facility for processing,” said Hillary Brendzel, head of Zipline’s US Healthcare Practice.

According to a 2022 survey from American Nurse Journal, 71% of nurses said that medical courier delays and errors negatively affected their ability to provide patient care. But with drone delivery, “lab samples can be sent for processing immediately, on-demand, resulting in faster diagnosis, treatment, and ultimately better outcomes,” said Ms. Brendzel.

4. Portable Ultrasound

Within the next 2 years, portable ultrasound — pocket-sized devices that connect to a smartphone or tablet — will become the “21st-century stethoscope,” said Abhilash Hareendranathan, PhD, assistant professor in the Department of Radiology and Diagnostic Imaging at the University of Alberta, in Edmonton, Alberta, Canada.

AI can make these devices easy to use, allowing clinicians with minimal imaging training to capture clear images and understand the results. Dr. Hareendranathan developed the Ultrasound Arm Injury Detection tool, a portable ultrasound that uses AI to detect fracture.

“We plan to introduce this technology in emergency departments, where it could be used by triage nurses to perform quick examinations to detect fractures of the wrist, elbow, or shoulder,” he said.

More pocket-sized scanners like these could “reshape the way diagnostic care is provided in rural and remote communities,” Dr. Hareendranathan said, and will “reduce wait times in crowded emergency departments.” Bill Gates believes enough in portable ultrasound that last September, the Bill & Melinda Gates Foundation granted $44 million to GE HealthCare to develop the technology for under-resourced communities.

5. Virtual Reality (VR)

When RelieVRx became the first US Food and Drug Administration (FDA)–approved VR therapy for chronic back pain in 2021, the technology was used in just a handful of Veterans Affairs (VA) facilities. But today, thousands of VR headsets have been deployed to more than 160 VA medical centers and clinics across the country.

“The VR experiences encompass pain neuroscience education, mindfulness, pleasant and relaxing distraction, and key skills to calm the nervous system,” said Beth Darnall, PhD, director of the Stanford Pain Relief Innovations Lab, who helped design the RelieVRx. She expects VR to go mainstream soon, not just because of increasing evidence that it works but also thanks to the Centers for Medicare & Medicaid Services, which recently issued a Healthcare Common Procedure Coding System code for VR. “This billing infrastructure will encourage adoption and uptake,” she said.

Hundreds of hospitals across the United States have already adopted the technology, for everything from childbirth pain to wound debridement, said Josh Sackman, the president and cofounder of AppliedVR, the company that developed RelieVRx.

“Over the next few years, we may see hundreds more deploy unique applications [for VR] that can handle multiple clinical indications,” he said. “Given the modality’s ability to scale and reduce reliance on pharmacological interventions, it has the power to improve the cost and quality of care.”

Hospital systems like Geisinger and Cedars-Sinai are already finding unique ways to implement the technology, he said, like using VR to reduce “scanxiety” during imaging service.

Other VR innovations are already being introduced, from the Smileyscope, a VR device for children that’s been proven to lessen the pain of a blood draw or intravenous insertion (it was cleared by the FDA last November) to several VR platforms launched by Cedars-Sinai in recent months, for applications that range from gastrointestinal issues to mental health therapy. “There may already be a thousand hospitals using VR in some capacity,” said Brennan Spiegel, MD, director of Health Services Research at Cedars-Sinai.

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) has approved a new treatment for uncomplicated urinary tract infections (UTIs). 

The agency on April 24 approved pivmecillinam tablets to treat women aged 18 years or older with UTIs caused by bacteria susceptible to the drug.

The beta-lactam antibiotic already is approved in Europe and has been used for more than 40 years outside of the United States to treat infections, according to the drug’s manufacturer, Utility Therapeutics. 

The drug is an aminopenicillin that rapidly converts to mecillinam, according to the company, which is marketing the medication as Pivya. 

Pivmecillinam is intended to treat UTIs caused by susceptible isolates of Escherichia coli, Proteus mirabilis, and Staphylococcus saprophyticus. 

Researchers studied the treatment in three clinical trials. One study found women who received the new antibiotic were more likely to have resolution of symptoms and a reduction in bacteria in urine compared with placebo (62% vs 10%). Similar results were seen in a trial that used ibuprofen as the comparator (66% vs 22%). 

In a third study that assessed two oral antibacterial drugs, 72% of women who received pivmecillinam and 76% who received the other drug achieved resolution of symptoms and a reduction in bacteria, according to the FDA. 

The most common side effects of pivmecillinam include nausea and diarrhea.

About half of all women will experience at least one UTI in their lifetime, and the infections are one the top reasons for antibiotic prescriptions, the FDA noted. 

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) has approved a new treatment for uncomplicated urinary tract infections (UTIs). 

The agency on April 24 approved pivmecillinam tablets to treat women aged 18 years or older with UTIs caused by bacteria susceptible to the drug.

The beta-lactam antibiotic already is approved in Europe and has been used for more than 40 years outside of the United States to treat infections, according to the drug’s manufacturer, Utility Therapeutics. 

The drug is an aminopenicillin that rapidly converts to mecillinam, according to the company, which is marketing the medication as Pivya. 

Pivmecillinam is intended to treat UTIs caused by susceptible isolates of Escherichia coli, Proteus mirabilis, and Staphylococcus saprophyticus. 

Researchers studied the treatment in three clinical trials. One study found women who received the new antibiotic were more likely to have resolution of symptoms and a reduction in bacteria in urine compared with placebo (62% vs 10%). Similar results were seen in a trial that used ibuprofen as the comparator (66% vs 22%). 

In a third study that assessed two oral antibacterial drugs, 72% of women who received pivmecillinam and 76% who received the other drug achieved resolution of symptoms and a reduction in bacteria, according to the FDA. 

The most common side effects of pivmecillinam include nausea and diarrhea.

About half of all women will experience at least one UTI in their lifetime, and the infections are one the top reasons for antibiotic prescriptions, the FDA noted. 

A version of this article appeared on Medscape.com.

The US Food and Drug Administration (FDA) has approved a new treatment for uncomplicated urinary tract infections (UTIs). 

The agency on April 24 approved pivmecillinam tablets to treat women aged 18 years or older with UTIs caused by bacteria susceptible to the drug.

The beta-lactam antibiotic already is approved in Europe and has been used for more than 40 years outside of the United States to treat infections, according to the drug’s manufacturer, Utility Therapeutics. 

The drug is an aminopenicillin that rapidly converts to mecillinam, according to the company, which is marketing the medication as Pivya. 

Pivmecillinam is intended to treat UTIs caused by susceptible isolates of Escherichia coli, Proteus mirabilis, and Staphylococcus saprophyticus. 

Researchers studied the treatment in three clinical trials. One study found women who received the new antibiotic were more likely to have resolution of symptoms and a reduction in bacteria in urine compared with placebo (62% vs 10%). Similar results were seen in a trial that used ibuprofen as the comparator (66% vs 22%). 

In a third study that assessed two oral antibacterial drugs, 72% of women who received pivmecillinam and 76% who received the other drug achieved resolution of symptoms and a reduction in bacteria, according to the FDA. 

The most common side effects of pivmecillinam include nausea and diarrhea.

About half of all women will experience at least one UTI in their lifetime, and the infections are one the top reasons for antibiotic prescriptions, the FDA noted. 

A version of this article appeared on Medscape.com.

Women who are considered to be at average risk for breast cancer should have mammograms every other year starting at age 40 years until age 74, according to the latest recommendations from the US Preventive Services Task Force (USPSTF).

In its updated recommendations published April 30 in JAMA, the USPSTF also made an urgent call to address reasons why Black women are more likely to die from breast cancer than are White women and pressed for more research to address persisting questions about how best to screen for cancer in dense breasts, which about 40% of women have. The USPSTF highlighted evidence gaps on the benefits and harms of continuing mammography after age 75 years as well.

The updated USPSTF recommendations were first unveiled last year in a draft version. 

In 2016, the task force recommended biennial mammograms for women starting 10 years later, at age 50 years, while stressing a need for clinicians and patients to weigh the risks and benefits of screening for those in their 40s. 

The shift to a general recommendation to start at age 40 years is based on a broad review of available data on mammography, including modeling from Cancer Intervention and Surveillance Modeling Network (CISNET).

Alongside the USPSTF report, JAMA published three separate editorials — a reflection of the controversy that these breast cancer screening recommendations often generate. 

In one editorial, published in JAMA Network Open, Lydia E. Pace, MD, MPH, and Nancy L. Keating, MD, MPH, highlighted that though screening earlier will prevent more deaths from breast cancer, it will also lead to more false positive findings and increase rates of overdiagnosis. 

Dr. Pace and Dr. Keating explained that the modeling study commissioned by the USPSTF estimated that screening every 2 years starting at age 40 years would avoid an additional 1.3 breast cancer deaths compared with screening at age 50 years. Among Black women, screening every 2 years starting at age 40 years would avert an extra 1.8 breast cancer deaths per 1000 people screened. 

However, the model also found that screening every 2 years starting at age 40 years would lead to more false positive tests — a rate of about 8.5% vs 7.8% for those starting at age 50.

“Given mammography screening’s modest benefits, we feel that all women — and particularly those aged 40 to 49 years —should be counseled about the benefits and harms of mammography and supported in deciding whether the balance of benefits to harms fits with their priorities and values,” wrote Dr. Pace and Dr. Keating, who specialize in internal medicine.

In a second editorial, in JAMA, Joann G. Elmore, MD, MPH, of UCLA, and Christoph I. Lee, MD, MS, of the University of Washington, Seattle, noted that the revised recommendations “shed light on 2 major issues that demand greater attention: addressing health inequities related to breast cancer outcomes and ensuring benefits for all women amid rapid screening technological advancements.” 

The USPSTF’s decision to recommend an earlier start age for routine mammography was partly intended to begin to address the fact that Black women are about 40% more likely to die from breast cancer than are White women.

“Despite greater absolute benefits of screening for Black women, the modeling study and systematic review underscore that mammography’s benefits (ie, breast cancer deaths averted) are modest for both Black women and the general population,” wrote Dr. Elmore and Dr. Lee.

The editorialists also cautioned against adopting artificial intelligence (AI) support tools too rapidly, criticizing the USPSTF for overlooking this “pressing issue.” 

“While AI algorithms show promise for enhancing cancer detection, their impact on patient outcomes and the balance between benefit and harms remain uncertain,” the editorialists wrote.

In a third editorial, in JAMA Oncology, Wendie A. Berg, MD, PhD, a radiologist at the University of Pittsburgh, argued that though the updated recommendations are “an important step forward,” they don’t go far enough.

Dr. Berg, for instance, noted her surprise “ to see the USPSTF recommendation only for biennial, rather than annual, screening among women aged 40 to 74 years.”

Compared with no screening, annual screening would reduce rates of breast cancer mortality (35.2%) more than biennial (28.4%) screening does among women aged 40-74 years, according to the CISNET modeling that informed the USPSTF’s decision.

Plus, Dr. Berg noted, regular risk assessments should begin at age 25 years “to identify women at high risk who should start annual MRI screenings.”

The American College of Radiology (ACR) offered similar views in a statement, saying the recommendations “do not go far enough to save more women’s lives.” It urged a more aggressive screening schedule, which starts at age 40 years but occurs annually vs biennially and continues past age 74 years. Like Dr. Berg, the ACR advocated for breast cancer risk assessments to begin at age 25 years.

The American Cancer Society also recommended annual mammography screening, starting as early as age 40 years in average-risk women, with high-risk women receiving a breast MRI and a mammogram every year starting at age 30 years.