AVAHO

The United States Food and Drug Administration (FDA) has approved bevacizumab-nwgd (Jobevne, Biocon Biologics Ltd), a biosimilar to bevacizumab (Avastin, Genentech), for intravenous use across multiple cancer types.

Approval was based on “a comprehensive package of comparative pharmacokinetic, safety, efficacy, nonclinical, structural, analytical and functional data, which confirmed the Jobevne is highly similar to Avastin,” according to a Biocon Biologics Ltd press release. 

“The data demonstrated that there were no clinically meaningful differences between Jobevne and Avastin in terms of pharmacokinetics, safety, efficacy, and immunogenicity,” the company stated.

The biosimilar agent is indicated as part of various combinations for the treatment of metastatic colorectal cancer, certain types of non-squamous non–small cell lung cancer, recurrent glioblastoma, metastatic renal cell carcinoma, certain advanced cervical cancers, and epithelial ovarian, fallopian tube, or primary peritoneal cancers, the company noted.

The agent is not indicated for adjuvant treatment of colon cancer, according to the press release, which includes detailed information about the indications, as well as a list of warnings and precautions.

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

The United States Food and Drug Administration (FDA) has approved bevacizumab-nwgd (Jobevne, Biocon Biologics Ltd), a biosimilar to bevacizumab (Avastin, Genentech), for intravenous use across multiple cancer types.

Approval was based on “a comprehensive package of comparative pharmacokinetic, safety, efficacy, nonclinical, structural, analytical and functional data, which confirmed the Jobevne is highly similar to Avastin,” according to a Biocon Biologics Ltd press release. 

“The data demonstrated that there were no clinically meaningful differences between Jobevne and Avastin in terms of pharmacokinetics, safety, efficacy, and immunogenicity,” the company stated.

The biosimilar agent is indicated as part of various combinations for the treatment of metastatic colorectal cancer, certain types of non-squamous non–small cell lung cancer, recurrent glioblastoma, metastatic renal cell carcinoma, certain advanced cervical cancers, and epithelial ovarian, fallopian tube, or primary peritoneal cancers, the company noted.

The agent is not indicated for adjuvant treatment of colon cancer, according to the press release, which includes detailed information about the indications, as well as a list of warnings and precautions.

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

The United States Food and Drug Administration (FDA) has approved bevacizumab-nwgd (Jobevne, Biocon Biologics Ltd), a biosimilar to bevacizumab (Avastin, Genentech), for intravenous use across multiple cancer types.

Approval was based on “a comprehensive package of comparative pharmacokinetic, safety, efficacy, nonclinical, structural, analytical and functional data, which confirmed the Jobevne is highly similar to Avastin,” according to a Biocon Biologics Ltd press release. 

“The data demonstrated that there were no clinically meaningful differences between Jobevne and Avastin in terms of pharmacokinetics, safety, efficacy, and immunogenicity,” the company stated.

The biosimilar agent is indicated as part of various combinations for the treatment of metastatic colorectal cancer, certain types of non-squamous non–small cell lung cancer, recurrent glioblastoma, metastatic renal cell carcinoma, certain advanced cervical cancers, and epithelial ovarian, fallopian tube, or primary peritoneal cancers, the company noted.

The agent is not indicated for adjuvant treatment of colon cancer, according to the press release, which includes detailed information about the indications, as well as a list of warnings and precautions.

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

Adam DuVall, MD, MPH, is a rare medical oncologist who trained in both adult and pediatric hematology/oncology.

This distinction, which DuVall said he shares with only a handful of oncologists in the world, matches his role at University of Chicago (UChicago) Medicine, Chicago. Since joining UChicago in 2020, DuVall has helped expand its Adolescent and Young Adult (AYA) Oncology Program, which aims to provide comprehensive, one-stop care and support for patients with cancer aged from 15 to 39 years.

Started in 2012, the program is one of the oldest in a growing array of initiatives nationwide that seek to address the specific psychosocial and other support needs of patients with cancer who fall into the gap between young children and the older patients who more typically have cancer. Along with DuVall and other oncologists, UChicago’s AYA Program offers dedicated nurse practitioners, social workers, psychologists, a physical therapist, and a program administrator. A community health worker, who does home visits, helps patients coordinate travel, works with their insurance, and generally navigates the medical system, DuVall added.

The program receives about 1500-2000 visits a year, according to DuVall. What the young adult population with cancer has in common that distinguishes it from other age cohorts, he said, are its members’ particular psychosocial needs. “Going through adolescence and young adulthood without cancer, there’s plenty of things that are hard,” DuVall observed. “Put cancer on top of that, and it impacts every aspect of life.”

‘Millennials Have Higher Risk’

The proliferation of AYA programs comes as more and more studies have been published recently showing that young adults are increasingly getting cancer.

According to American Cancer Society research published in December in The Lancet Oncology, incidence rates of colorectal cancer (CRC) among young adults aged 25-49 years rose in the decade through 2017 in more than half of the 50 countries and territories examined. For the past 5 years studied, the incidence rate of early-onset CRC was highest in Australia, Puerto Rico, New Zealand, the United States, and South Korea. At the same time, the study found, rates among older adults in all of those places except South Korea were stable or declining.

Hyuna Sung, PhD, the study’s lead author, said, “Research has shown that Gen X and millennials have higher risk of multiple types of cancer compared to the older generations.”

Some of the cancers found to be increasing among younger adults are linked to “excess body obesity,” Sung said, including not only CRC but also cancers of the uterine corpus, gallbladder, kidney, pancreas, breast, and stomach cardia, as well as myeloma. Early onset of cancers not linked to obesity, such as testicular cancer and small intestinal cancer, has also been shown to be on the rise, Sung noted.

As cancer rates among young adults have risen, nonprofits have stepped in to help medical institutions open programs geared to their needs. Teen Cancer America, founded by members of rock band The Who, has partnered with 64 hospitals in 36 cities to develop AYA-focused programs, funding 85 hospital positions, according to a spokesperson. The Los Angeles–based nonprofit has also provided free consultation to 130 hospitals without formally providing a grant, the spokesperson said.

A map on Teen Cancer America’s website illustrates the nationwide spread of AYA programs, from UCLA Santa Monica Medical Center to Memorial Sloan Kettering Cancer Center in New York City, with more in between.

‘Setting Them Up for a Life of Meaning’

Michael Roth, MD, co-director of the AYA Program at the University of Texas MD Anderson Cancer Center in Houston, likes to say, “If you’ve seen one AYA Program, you’ve seen one AYA Program.”

In other words, offerings vary. “Most centers do not have comprehensive AYA programs,” Roth said, noting that at many sites the AYA Program might consist of oncofertility support. “That said, programs are doing the best they can, knowing that the AYA population is growing exponentially globally.”

Almost 90,000 AYA patients are diagnosed with cancer each year, and 85% will be at least 5-year survivors, Roth said. There are more than 2 million survivors of AYA cancer, he added, and if the median age of diagnosis is 30, they can live five decades beyond their cancer treatment. “Their life matters,” Roth said. “It matters during treatment. Their life after cancer matters.”

The AYA Program at MD Anderson began in 2017, and it sees more than 2000 AYAs diagnosed with cancer every year, according to Roth. The program is designed to complement the care that patients with cancer aged from 15 to 39 years or older may already be receiving from their primary treatment teams. New patients see a medical provider, a social worker, and a vocational counselor for discussions about their needs and concerns, and they have access to a nutritionist and genetic counselor.

The program offers psychosocial and supportive care for patients who may be facing challenges with school, work, relationships, having young children, and mental health, Roth said. Along with assessments and counseling around fertility risks and genetic predisposition, MD Anderson also provides patients in the program with a long-term survivorship plan.

“It’s not just increasing cures,” Roth observed. “We’re also setting them up for a life of meaning and happiness and productivity and health.”

Almost 40% of visits to the program are conducted virtually, according to Roth. “Our goal is to meet the patients where they are,” he said. “We want to be convenient, not be a burden.”

‘The Face of Cancer Has Changed’

Patients with AYA cancer diagnoses may be finishing up school or starting a job, developing their body image and sexual identity, or caring for young children or older parents.

“They feel incredibly isolated,” said Ann LaCasce, MD, MMSc, co-director of the Center for Adolescent and Young Adult Oncology at Dana-Farber Cancer Institute in Boston. “They go into the cancer center or their community practice, and everyone is double, triple their age.”

Last year, Dana-Farber opened a Young Adult Lounge meant for patients aged 18 years or older to be able to relax and, if they wish, interact between appointments. “When you talk to these patients, they want to meet each other,” LaCasce said. “They want to share experiences.”

The Young Adults With Cancer Program at Vanderbilt-Ingram Cancer Center in Nashville, Tennessee, opened its doors in 2019. It recently hired an interim nurse navigator, said Cathy Eng, MD, FACP, FASCO, director of the Program, which concentrates on patients aged 25-45 years.

“The face of cancer has changed,” Eng said.

She advises other oncologists to talk to their young adult patients as much as possible. “Really talk to them as an individual and see what other needs they have,” she said. “Even if they don’t tell you the first time, ask them the second time, ask them the third time.”

Christopher Cann, MD, executive director of the Young Adult Cancer Program at Fox Chase Cancer Center in Philadelphia, did his fellowship under Eng. He joined Fox Chase in 2023, and the Young Adult Cancer Program started accepting patients around the end of last year, zeroing in on patients aged 18-39 years.

Following the implementation of a new best practice advisory that pops up in the medical records system, he said, oncofertility referrals increased by 400% within 6 months.

“My hope is that if every institution throughout the country can have a young adult program, even something small like this can provide a large impact for patients,” Cann said.

The University of North Carolina (UNC) AYA Cancer Program, part of the Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, formed in 2015. It has expanded into a team of about 12 including a nurse practitioner, fertility counselor, and psychologist, said Jacob Stein, MD, MPH, the program’s AYA oncology liaison. UNC sees about 400 AYA patients with cancer annually, and the program interacts with slightly more than 100 of them, according to Stein.

“Our program has taken a very different approach, to target services, contact, and engagement with AYAs who we perceive to be at the highest need, either clinically or socially, for support,” he said.

Stein was the lead author on research presented last year at the ASCO Quality Care Symposium in San Francisco finding that patients engaged in the program were more likely to participate in clinical trials and received higher rates of fertility preservation and palliative care than AYA patients at UNC without program contact.

Andrew Smitherman, MD, MS, medical director of the UNC AYA Cancer Center Program, said the AYA field has grown impressively since a progress review group was started in 2005, which was backed by the National Cancer Institute and LIVESTRONG Young Adult Alliance. The group developed recommendations to address AYA oncology nationwide, in hopes of acting as a catalyst for future initiatives. Clearly, others caring for patients with cancer heard the message.

“If a colleague comes to me and says, ‘Where do I start, how do I make this change at my institution,’ I usually lead with changing the culture,” Smitherman said. “Educating hospital leadership about the importance of this population, educating colleagues, finding partners. And then start thinking about ways to make structural changes, like creating space. That’s worked really well for us.”

DuVall, Sung, Roth, LaCasce, Eng, Cann, Stein, and Smitherman declared no conflicts of interest.

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

Adam DuVall, MD, MPH, is a rare medical oncologist who trained in both adult and pediatric hematology/oncology.

This distinction, which DuVall said he shares with only a handful of oncologists in the world, matches his role at University of Chicago (UChicago) Medicine, Chicago. Since joining UChicago in 2020, DuVall has helped expand its Adolescent and Young Adult (AYA) Oncology Program, which aims to provide comprehensive, one-stop care and support for patients with cancer aged from 15 to 39 years.

Started in 2012, the program is one of the oldest in a growing array of initiatives nationwide that seek to address the specific psychosocial and other support needs of patients with cancer who fall into the gap between young children and the older patients who more typically have cancer. Along with DuVall and other oncologists, UChicago’s AYA Program offers dedicated nurse practitioners, social workers, psychologists, a physical therapist, and a program administrator. A community health worker, who does home visits, helps patients coordinate travel, works with their insurance, and generally navigates the medical system, DuVall added.

The program receives about 1500-2000 visits a year, according to DuVall. What the young adult population with cancer has in common that distinguishes it from other age cohorts, he said, are its members’ particular psychosocial needs. “Going through adolescence and young adulthood without cancer, there’s plenty of things that are hard,” DuVall observed. “Put cancer on top of that, and it impacts every aspect of life.”

‘Millennials Have Higher Risk’

The proliferation of AYA programs comes as more and more studies have been published recently showing that young adults are increasingly getting cancer.

According to American Cancer Society research published in December in The Lancet Oncology, incidence rates of colorectal cancer (CRC) among young adults aged 25-49 years rose in the decade through 2017 in more than half of the 50 countries and territories examined. For the past 5 years studied, the incidence rate of early-onset CRC was highest in Australia, Puerto Rico, New Zealand, the United States, and South Korea. At the same time, the study found, rates among older adults in all of those places except South Korea were stable or declining.

Hyuna Sung, PhD, the study’s lead author, said, “Research has shown that Gen X and millennials have higher risk of multiple types of cancer compared to the older generations.”

Some of the cancers found to be increasing among younger adults are linked to “excess body obesity,” Sung said, including not only CRC but also cancers of the uterine corpus, gallbladder, kidney, pancreas, breast, and stomach cardia, as well as myeloma. Early onset of cancers not linked to obesity, such as testicular cancer and small intestinal cancer, has also been shown to be on the rise, Sung noted.

As cancer rates among young adults have risen, nonprofits have stepped in to help medical institutions open programs geared to their needs. Teen Cancer America, founded by members of rock band The Who, has partnered with 64 hospitals in 36 cities to develop AYA-focused programs, funding 85 hospital positions, according to a spokesperson. The Los Angeles–based nonprofit has also provided free consultation to 130 hospitals without formally providing a grant, the spokesperson said.

A map on Teen Cancer America’s website illustrates the nationwide spread of AYA programs, from UCLA Santa Monica Medical Center to Memorial Sloan Kettering Cancer Center in New York City, with more in between.

‘Setting Them Up for a Life of Meaning’

Michael Roth, MD, co-director of the AYA Program at the University of Texas MD Anderson Cancer Center in Houston, likes to say, “If you’ve seen one AYA Program, you’ve seen one AYA Program.”

In other words, offerings vary. “Most centers do not have comprehensive AYA programs,” Roth said, noting that at many sites the AYA Program might consist of oncofertility support. “That said, programs are doing the best they can, knowing that the AYA population is growing exponentially globally.”

Almost 90,000 AYA patients are diagnosed with cancer each year, and 85% will be at least 5-year survivors, Roth said. There are more than 2 million survivors of AYA cancer, he added, and if the median age of diagnosis is 30, they can live five decades beyond their cancer treatment. “Their life matters,” Roth said. “It matters during treatment. Their life after cancer matters.”

The AYA Program at MD Anderson began in 2017, and it sees more than 2000 AYAs diagnosed with cancer every year, according to Roth. The program is designed to complement the care that patients with cancer aged from 15 to 39 years or older may already be receiving from their primary treatment teams. New patients see a medical provider, a social worker, and a vocational counselor for discussions about their needs and concerns, and they have access to a nutritionist and genetic counselor.

The program offers psychosocial and supportive care for patients who may be facing challenges with school, work, relationships, having young children, and mental health, Roth said. Along with assessments and counseling around fertility risks and genetic predisposition, MD Anderson also provides patients in the program with a long-term survivorship plan.

“It’s not just increasing cures,” Roth observed. “We’re also setting them up for a life of meaning and happiness and productivity and health.”

Almost 40% of visits to the program are conducted virtually, according to Roth. “Our goal is to meet the patients where they are,” he said. “We want to be convenient, not be a burden.”

‘The Face of Cancer Has Changed’

Patients with AYA cancer diagnoses may be finishing up school or starting a job, developing their body image and sexual identity, or caring for young children or older parents.

“They feel incredibly isolated,” said Ann LaCasce, MD, MMSc, co-director of the Center for Adolescent and Young Adult Oncology at Dana-Farber Cancer Institute in Boston. “They go into the cancer center or their community practice, and everyone is double, triple their age.”

Last year, Dana-Farber opened a Young Adult Lounge meant for patients aged 18 years or older to be able to relax and, if they wish, interact between appointments. “When you talk to these patients, they want to meet each other,” LaCasce said. “They want to share experiences.”

The Young Adults With Cancer Program at Vanderbilt-Ingram Cancer Center in Nashville, Tennessee, opened its doors in 2019. It recently hired an interim nurse navigator, said Cathy Eng, MD, FACP, FASCO, director of the Program, which concentrates on patients aged 25-45 years.

“The face of cancer has changed,” Eng said.

She advises other oncologists to talk to their young adult patients as much as possible. “Really talk to them as an individual and see what other needs they have,” she said. “Even if they don’t tell you the first time, ask them the second time, ask them the third time.”

Christopher Cann, MD, executive director of the Young Adult Cancer Program at Fox Chase Cancer Center in Philadelphia, did his fellowship under Eng. He joined Fox Chase in 2023, and the Young Adult Cancer Program started accepting patients around the end of last year, zeroing in on patients aged 18-39 years.

Following the implementation of a new best practice advisory that pops up in the medical records system, he said, oncofertility referrals increased by 400% within 6 months.

“My hope is that if every institution throughout the country can have a young adult program, even something small like this can provide a large impact for patients,” Cann said.

The University of North Carolina (UNC) AYA Cancer Program, part of the Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, formed in 2015. It has expanded into a team of about 12 including a nurse practitioner, fertility counselor, and psychologist, said Jacob Stein, MD, MPH, the program’s AYA oncology liaison. UNC sees about 400 AYA patients with cancer annually, and the program interacts with slightly more than 100 of them, according to Stein.

“Our program has taken a very different approach, to target services, contact, and engagement with AYAs who we perceive to be at the highest need, either clinically or socially, for support,” he said.

Stein was the lead author on research presented last year at the ASCO Quality Care Symposium in San Francisco finding that patients engaged in the program were more likely to participate in clinical trials and received higher rates of fertility preservation and palliative care than AYA patients at UNC without program contact.

Andrew Smitherman, MD, MS, medical director of the UNC AYA Cancer Center Program, said the AYA field has grown impressively since a progress review group was started in 2005, which was backed by the National Cancer Institute and LIVESTRONG Young Adult Alliance. The group developed recommendations to address AYA oncology nationwide, in hopes of acting as a catalyst for future initiatives. Clearly, others caring for patients with cancer heard the message.

“If a colleague comes to me and says, ‘Where do I start, how do I make this change at my institution,’ I usually lead with changing the culture,” Smitherman said. “Educating hospital leadership about the importance of this population, educating colleagues, finding partners. And then start thinking about ways to make structural changes, like creating space. That’s worked really well for us.”

DuVall, Sung, Roth, LaCasce, Eng, Cann, Stein, and Smitherman declared no conflicts of interest.

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

Adam DuVall, MD, MPH, is a rare medical oncologist who trained in both adult and pediatric hematology/oncology.

This distinction, which DuVall said he shares with only a handful of oncologists in the world, matches his role at University of Chicago (UChicago) Medicine, Chicago. Since joining UChicago in 2020, DuVall has helped expand its Adolescent and Young Adult (AYA) Oncology Program, which aims to provide comprehensive, one-stop care and support for patients with cancer aged from 15 to 39 years.

Started in 2012, the program is one of the oldest in a growing array of initiatives nationwide that seek to address the specific psychosocial and other support needs of patients with cancer who fall into the gap between young children and the older patients who more typically have cancer. Along with DuVall and other oncologists, UChicago’s AYA Program offers dedicated nurse practitioners, social workers, psychologists, a physical therapist, and a program administrator. A community health worker, who does home visits, helps patients coordinate travel, works with their insurance, and generally navigates the medical system, DuVall added.

The program receives about 1500-2000 visits a year, according to DuVall. What the young adult population with cancer has in common that distinguishes it from other age cohorts, he said, are its members’ particular psychosocial needs. “Going through adolescence and young adulthood without cancer, there’s plenty of things that are hard,” DuVall observed. “Put cancer on top of that, and it impacts every aspect of life.”

‘Millennials Have Higher Risk’

The proliferation of AYA programs comes as more and more studies have been published recently showing that young adults are increasingly getting cancer.

According to American Cancer Society research published in December in The Lancet Oncology, incidence rates of colorectal cancer (CRC) among young adults aged 25-49 years rose in the decade through 2017 in more than half of the 50 countries and territories examined. For the past 5 years studied, the incidence rate of early-onset CRC was highest in Australia, Puerto Rico, New Zealand, the United States, and South Korea. At the same time, the study found, rates among older adults in all of those places except South Korea were stable or declining.

Hyuna Sung, PhD, the study’s lead author, said, “Research has shown that Gen X and millennials have higher risk of multiple types of cancer compared to the older generations.”

Some of the cancers found to be increasing among younger adults are linked to “excess body obesity,” Sung said, including not only CRC but also cancers of the uterine corpus, gallbladder, kidney, pancreas, breast, and stomach cardia, as well as myeloma. Early onset of cancers not linked to obesity, such as testicular cancer and small intestinal cancer, has also been shown to be on the rise, Sung noted.

As cancer rates among young adults have risen, nonprofits have stepped in to help medical institutions open programs geared to their needs. Teen Cancer America, founded by members of rock band The Who, has partnered with 64 hospitals in 36 cities to develop AYA-focused programs, funding 85 hospital positions, according to a spokesperson. The Los Angeles–based nonprofit has also provided free consultation to 130 hospitals without formally providing a grant, the spokesperson said.

A map on Teen Cancer America’s website illustrates the nationwide spread of AYA programs, from UCLA Santa Monica Medical Center to Memorial Sloan Kettering Cancer Center in New York City, with more in between.

‘Setting Them Up for a Life of Meaning’

Michael Roth, MD, co-director of the AYA Program at the University of Texas MD Anderson Cancer Center in Houston, likes to say, “If you’ve seen one AYA Program, you’ve seen one AYA Program.”

In other words, offerings vary. “Most centers do not have comprehensive AYA programs,” Roth said, noting that at many sites the AYA Program might consist of oncofertility support. “That said, programs are doing the best they can, knowing that the AYA population is growing exponentially globally.”

Almost 90,000 AYA patients are diagnosed with cancer each year, and 85% will be at least 5-year survivors, Roth said. There are more than 2 million survivors of AYA cancer, he added, and if the median age of diagnosis is 30, they can live five decades beyond their cancer treatment. “Their life matters,” Roth said. “It matters during treatment. Their life after cancer matters.”

The AYA Program at MD Anderson began in 2017, and it sees more than 2000 AYAs diagnosed with cancer every year, according to Roth. The program is designed to complement the care that patients with cancer aged from 15 to 39 years or older may already be receiving from their primary treatment teams. New patients see a medical provider, a social worker, and a vocational counselor for discussions about their needs and concerns, and they have access to a nutritionist and genetic counselor.

The program offers psychosocial and supportive care for patients who may be facing challenges with school, work, relationships, having young children, and mental health, Roth said. Along with assessments and counseling around fertility risks and genetic predisposition, MD Anderson also provides patients in the program with a long-term survivorship plan.

“It’s not just increasing cures,” Roth observed. “We’re also setting them up for a life of meaning and happiness and productivity and health.”

Almost 40% of visits to the program are conducted virtually, according to Roth. “Our goal is to meet the patients where they are,” he said. “We want to be convenient, not be a burden.”

‘The Face of Cancer Has Changed’

Patients with AYA cancer diagnoses may be finishing up school or starting a job, developing their body image and sexual identity, or caring for young children or older parents.

“They feel incredibly isolated,” said Ann LaCasce, MD, MMSc, co-director of the Center for Adolescent and Young Adult Oncology at Dana-Farber Cancer Institute in Boston. “They go into the cancer center or their community practice, and everyone is double, triple their age.”

Last year, Dana-Farber opened a Young Adult Lounge meant for patients aged 18 years or older to be able to relax and, if they wish, interact between appointments. “When you talk to these patients, they want to meet each other,” LaCasce said. “They want to share experiences.”

The Young Adults With Cancer Program at Vanderbilt-Ingram Cancer Center in Nashville, Tennessee, opened its doors in 2019. It recently hired an interim nurse navigator, said Cathy Eng, MD, FACP, FASCO, director of the Program, which concentrates on patients aged 25-45 years.

“The face of cancer has changed,” Eng said.

She advises other oncologists to talk to their young adult patients as much as possible. “Really talk to them as an individual and see what other needs they have,” she said. “Even if they don’t tell you the first time, ask them the second time, ask them the third time.”

Christopher Cann, MD, executive director of the Young Adult Cancer Program at Fox Chase Cancer Center in Philadelphia, did his fellowship under Eng. He joined Fox Chase in 2023, and the Young Adult Cancer Program started accepting patients around the end of last year, zeroing in on patients aged 18-39 years.

Following the implementation of a new best practice advisory that pops up in the medical records system, he said, oncofertility referrals increased by 400% within 6 months.

“My hope is that if every institution throughout the country can have a young adult program, even something small like this can provide a large impact for patients,” Cann said.

The University of North Carolina (UNC) AYA Cancer Program, part of the Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, formed in 2015. It has expanded into a team of about 12 including a nurse practitioner, fertility counselor, and psychologist, said Jacob Stein, MD, MPH, the program’s AYA oncology liaison. UNC sees about 400 AYA patients with cancer annually, and the program interacts with slightly more than 100 of them, according to Stein.

“Our program has taken a very different approach, to target services, contact, and engagement with AYAs who we perceive to be at the highest need, either clinically or socially, for support,” he said.

Stein was the lead author on research presented last year at the ASCO Quality Care Symposium in San Francisco finding that patients engaged in the program were more likely to participate in clinical trials and received higher rates of fertility preservation and palliative care than AYA patients at UNC without program contact.

Andrew Smitherman, MD, MS, medical director of the UNC AYA Cancer Center Program, said the AYA field has grown impressively since a progress review group was started in 2005, which was backed by the National Cancer Institute and LIVESTRONG Young Adult Alliance. The group developed recommendations to address AYA oncology nationwide, in hopes of acting as a catalyst for future initiatives. Clearly, others caring for patients with cancer heard the message.

“If a colleague comes to me and says, ‘Where do I start, how do I make this change at my institution,’ I usually lead with changing the culture,” Smitherman said. “Educating hospital leadership about the importance of this population, educating colleagues, finding partners. And then start thinking about ways to make structural changes, like creating space. That’s worked really well for us.”

DuVall, Sung, Roth, LaCasce, Eng, Cann, Stein, and Smitherman declared no conflicts of interest.

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

The US Food and Drug Administration (FDA) has approved nivolumab (Opdivo, Bristol Myers Squibb) with ipilimumab (Yervoy, Bristol Myers Squibb) as a first-line treatment for adults with unresectable or metastatic hepatocellular carcinoma (HCC). 

The decision, which follows the FDA’s 2020 accelerated approval in the second-line setting for advanced HCC and adds to the list of other indications for the combination therapy, was based on efficacy demonstrated in the randomized, open-label CHECKMATE-9DW trial. The trial enrolled 668 patients with unresectable or metastatic HCC and no prior systemic therapy for advanced disease, according to the FDA approval notice. 

Median overall survival, the primary outcome measure, was 23.7 months in those randomized to receive nivolumab + ipilimumab, compared with 20.6 months in those randomized to receive investigators’ choice of lenvatinib or sorafenib (hazard ratio, 0.79). The overall response rate was 36.1% vs 13.2% in the arms, respectively.

Those in the treatment arm received 1 mg/kg intravenous (IV) nivolumab with 3 mg/kg IV ipilimumab every 3 weeks for up to four doses, followed by single-agent IV nivolumab at 480 mg every 4 weeks. Those in the control arm received either 8 or 12 mg lenvatinib daily or 400 mg sorafenib twice daily until disease progression or unacceptable toxicity, according to early results from the trial, which were presented at the 2024 American Society of Clinical Oncology meeting. 

Adverse reactions occurring in more than 20% of patients included rash, pruritus, fatigue, and diarrhea.

The recommended nivolumab dose for this indication is 1 mg/kg with 3 mg/kg ipilimumab given intravenously every 3 weeks for up to four doses, followed by 240 mg nivolumab every 2 weeks or 480 mg nivolumab every 4 weeks. Full prescribing information will be available at Drugs@FDA.

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

The US Food and Drug Administration (FDA) has approved nivolumab (Opdivo, Bristol Myers Squibb) with ipilimumab (Yervoy, Bristol Myers Squibb) as a first-line treatment for adults with unresectable or metastatic hepatocellular carcinoma (HCC). 

The decision, which follows the FDA’s 2020 accelerated approval in the second-line setting for advanced HCC and adds to the list of other indications for the combination therapy, was based on efficacy demonstrated in the randomized, open-label CHECKMATE-9DW trial. The trial enrolled 668 patients with unresectable or metastatic HCC and no prior systemic therapy for advanced disease, according to the FDA approval notice. 

Median overall survival, the primary outcome measure, was 23.7 months in those randomized to receive nivolumab + ipilimumab, compared with 20.6 months in those randomized to receive investigators’ choice of lenvatinib or sorafenib (hazard ratio, 0.79). The overall response rate was 36.1% vs 13.2% in the arms, respectively.

Those in the treatment arm received 1 mg/kg intravenous (IV) nivolumab with 3 mg/kg IV ipilimumab every 3 weeks for up to four doses, followed by single-agent IV nivolumab at 480 mg every 4 weeks. Those in the control arm received either 8 or 12 mg lenvatinib daily or 400 mg sorafenib twice daily until disease progression or unacceptable toxicity, according to early results from the trial, which were presented at the 2024 American Society of Clinical Oncology meeting. 

Adverse reactions occurring in more than 20% of patients included rash, pruritus, fatigue, and diarrhea.

The recommended nivolumab dose for this indication is 1 mg/kg with 3 mg/kg ipilimumab given intravenously every 3 weeks for up to four doses, followed by 240 mg nivolumab every 2 weeks or 480 mg nivolumab every 4 weeks. Full prescribing information will be available at Drugs@FDA.

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

The US Food and Drug Administration (FDA) has approved nivolumab (Opdivo, Bristol Myers Squibb) with ipilimumab (Yervoy, Bristol Myers Squibb) as a first-line treatment for adults with unresectable or metastatic hepatocellular carcinoma (HCC). 

The decision, which follows the FDA’s 2020 accelerated approval in the second-line setting for advanced HCC and adds to the list of other indications for the combination therapy, was based on efficacy demonstrated in the randomized, open-label CHECKMATE-9DW trial. The trial enrolled 668 patients with unresectable or metastatic HCC and no prior systemic therapy for advanced disease, according to the FDA approval notice. 

Median overall survival, the primary outcome measure, was 23.7 months in those randomized to receive nivolumab + ipilimumab, compared with 20.6 months in those randomized to receive investigators’ choice of lenvatinib or sorafenib (hazard ratio, 0.79). The overall response rate was 36.1% vs 13.2% in the arms, respectively.

Those in the treatment arm received 1 mg/kg intravenous (IV) nivolumab with 3 mg/kg IV ipilimumab every 3 weeks for up to four doses, followed by single-agent IV nivolumab at 480 mg every 4 weeks. Those in the control arm received either 8 or 12 mg lenvatinib daily or 400 mg sorafenib twice daily until disease progression or unacceptable toxicity, according to early results from the trial, which were presented at the 2024 American Society of Clinical Oncology meeting. 

Adverse reactions occurring in more than 20% of patients included rash, pruritus, fatigue, and diarrhea.

The recommended nivolumab dose for this indication is 1 mg/kg with 3 mg/kg ipilimumab given intravenously every 3 weeks for up to four doses, followed by 240 mg nivolumab every 2 weeks or 480 mg nivolumab every 4 weeks. Full prescribing information will be available at Drugs@FDA.

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

One patient, a 39-year-old woman, went to a dermatologist seeking care for fluid-filled blisters over the backs of her hands and arms. Another patient, a 56-year-old man, sought care from his general practitioner owing to fatigue.

Their presentations were quite different, but the two patients shared one thing in common: iron overload. Both ended up in the care of hematologists who diagnosed their conditions as porphyria cutanea tarda (PCT) and hemochromatosis, respectively.

A pair of hematologists discussed the treatment of these disorders at the American Society of Hematology (ASH) 2024 Annual Meeting and in reports in Hematology: American Society of Hematology Education Program. Here’s a look at the guidance they provided.

 

Porphyria Cutanea Tarda: Skin Trouble

Testing revealed that the female patient had a highly elevated porphyrin levels: Her urine uroporphyrin was 3959  nmol/L (normal, < 30 nmol/L) and plasma uroporphyrin was 2.0 µg/dL (normal, < 1.0  µg/dL). Her serum ferritin level was also high, at 420 ng/mL (normal, < 200 ng/mL).

Rebecca Karp Leaf, MD, of Massachusetts General Hospital and Harvard Medical School, diagnosed her with PCT, a disorder of heme biosynthesis that often presents with skin manifestations.

As co-founder and co-director of the Boston hospital’s Porphyria Center, Karp Leaf is a leading expert in PCT, a rare disease that affects 5-10 people per 100,000. In addition to speaking at the ASH meeting in December, she described PCT in a December 2024 article in Hematology: American Society of Hematology Education Program. 

PCT is caused by inhibition of an enzyme in heme biosynthesis and leads to accumulation of porphyrins in the liver and plasma, Karp Leaf said. Through a complex process, excess of iron leads to inhibition of the enzyme, which leads to a buildup of toxic porphyrins, she said. The condition causes painless, blistering lesions on sun-exposed skin, scarring, skin fragility, dark urine, and liver disease. 

PCT most commonly occurs in middle age after the age of 40 and affects men more than women. “It’s the only porphyria that can occur absent a genetic variant,” she said, and 75% of cases have no genetic component. 

 

Options for Treatment Include Antivirals and Phlebotomy

Risk factors for PCT include alcohol use, smoking, exogenous estrogen, hepatitis, and HIV mutations. 

In regard to treatment, “modification of risk factors can be variably helpful: alcohol and smoking cessation, stopping exogenous estrogen, sun-protective clothing, and steroid-containing creams for lesions,” Karp Leaf said. “Most patients typically require further therapy to reduce liver porphyrins.”

Urine and plasma tests can help with diagnosis, she said. In patients with hepatitis C (HCV), “direct-acting antivirals can actually lead to resolution of PCT without any other therapy. We suspect that with effective antiviral treatment for HCV, the incidence of PCT will really go down.”

Therapeutic phlebotomy — blood removal — is another option. “It’s one of my favorite therapies because you don’t have to give somebody a drug. You can just take out iron,” Karp Leaf said. “Typically, we’ll start with venesection of 450 ccs of whole blood every 2 weeks, We target a ferritin level of 20 [ng/mL] but permit it up to 50 [ng/mL], or a little bit higher.”

The treatment leads to resolution of blisters in about 2-3 months, she said, and normalization of porphyrins by 13 months. Patients typically require about 6-8 treatments, she said. 

Another option is iron chelation, iron removal via medicine, “but it’s expensive, has side effects, and is really not recommended if other treatments are available,” she said. 

 

Hydroxychloroquine Can Be Helpful Too

Low-dose hydroxychloroquine can also be effective at 100 mg twice a week, “much lower than what we use in autoimmune disease,” Karp Leaf said. “We suspect that it’s taken up by the hepatic lysosomes and causes release of porphyrins. It causes clinical remission in about 6 months.”

However, higher doses can lead to liver injury, and the drug’s use is limited in end-stage kidney disease since porphyrins are excreted in the urine. These patients are especially difficult to treat, she said.

In the case of the 39-year-old patient, Karp Leaf recommended that the woman reduce her alcohol intake and begin using a copper intrauterine device for contraception instead of a combined oral contraceptive pill, which allowed her to undergo phlebotomy.

“She needed about eight sessions of therapeutic phlebotomy to achieve a ferritin of 30 [ng/mL], and her lesions resolved in 6 months,” Karp Leaf said. “Her plasma porphyrins resolved by 12 months. Her liver biochemistries were a bit elevated, and they subsequently normalized.”

Karp Leaf said she sees the patient about once a year. 

 

Hemochromatosis: It’s (Probably) a Family Affair

In an adjoining presentation at ASH and in a December 2024 article in Hematology: American Society of Hematology Education Program, hematologist Domenico Girelli, MD, PhD, with the University of Verona, Italy, told colleagues about the 56-year-old male patient with fatigue. He also had a mildly enlarged liver, hyperferritinemia (890  µg/L vs normal value < 300 µg/L) and a mildly increased alanine aminotransferase level (46 U/L vs normal value < 40 U/L).

The patient was diagnosed with hemochromatosis, a genetic disorder caused by mutations that leads to increased transferrin saturation, Girelli said. 

“By definition, hemochromatosis is characterized by the absence of signs of a primary red blood cell disorder — different from other disorders like transfusion iron overload or iron-loading anemias,” he said. 

It’s also important to consider other possible causes of hyperferritinemia, because most cases of the symptom aren’t related to iron overload, he said. “A careful clinical history and a few laboratory parameters including transferrin saturation are generally sufficient for the differential diagnosis.”

As Girelli noted, “hemochromatosis can have a wide clinical spectrum ranging from mild to severe forms, which are strongly influenced by the co-presence of risk factors like alcohol [use], blood transfusion, and genetic factors captured by polygenic risk score.”

 

In Many Cases, Hemochromatosis Can Be Successfully Treated

According to Girelli, it’s important to understand the disease stage, because this information can predict the probability of advanced liver fibrosis, which can be a sign of a worse prognosis.

“The strongest clinical predictors of advanced liver fibrosis are ferritin higher than 1000 [µg/L] and the presence of arthropathy [joint disease],” he said. “If both are absent and the patient is asymptomatic, there is no need for further investigation. If both are present, further investigation — including cardiac MRI and full endocrine profile — are indicated. Liver biopsy may be indicated only in uncertain cases.”

Fortunately, “most patients are diagnosed in preclinical or early stage, and their prognosis is excellent, with a normal life expectancy,” he said 

Phlebotomy remains the standard of care for hemochromatosis in uncomplicated cases. “It is safe, cheap, well-tolerated, and significantly reduces mortality and morbidity, especially when it is started before the development of cirrhosis,” he said. 

 

Family Members Should Be Tested for Genetic Traits

It’s important to advise patients prior to phlebotomy to avoid undercooked seafood and wound contact with sea water because of the risk for sepsis due to the pathogen Vibrio vulnificus, Girelli said. 

And it’s a good idea to test family members to see if they share a genetic risk for hemochromatosis, he said. The 56-year-old patient’s brother turned out to also have genetic risk, and his iron levels were very high. He had recently been diagnosed with seronegative arthritis that could be classified as secondary to hemochromatosis.

For management, Girelli said, patients should minimize or avoid alcohol consumption, eat a healthy diet, and avoid vitamin C and iron supplements even in multivitamin compounds. Patients should be encouraged to exercise and maintain an ideal weight. 

The 56-year-old patient fared well, reaching a ferritin target of 50 mg/mL after multiple phlebotomy procedures that removed nearly 5 g of iron.

The patient tolerated the treatment and his fatigue resolved, Girelli said. “The maintenance treatment consisted of 3 phlebotomies per year. The patient remained asymptomatic and was eventually enrolled as a regular blood donor.”

Karp Leaf disclosed relationships with Alnylam, Recordati, and Disc Medicine. She is a member of the Porphyrias Consortium, part of the Rare Diseases Clinical Research Network, funded by the National Institutes of Health and led by the National Center for Advancing Translational Sciences (NCATS). The consortium is funded by NCATS and the National Institute of Diabetes and Digestive and Kidney Diseases. Girelli had no disclosures.

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

One patient, a 39-year-old woman, went to a dermatologist seeking care for fluid-filled blisters over the backs of her hands and arms. Another patient, a 56-year-old man, sought care from his general practitioner owing to fatigue.

Their presentations were quite different, but the two patients shared one thing in common: iron overload. Both ended up in the care of hematologists who diagnosed their conditions as porphyria cutanea tarda (PCT) and hemochromatosis, respectively.

A pair of hematologists discussed the treatment of these disorders at the American Society of Hematology (ASH) 2024 Annual Meeting and in reports in Hematology: American Society of Hematology Education Program. Here’s a look at the guidance they provided.

 

Porphyria Cutanea Tarda: Skin Trouble

Testing revealed that the female patient had a highly elevated porphyrin levels: Her urine uroporphyrin was 3959  nmol/L (normal, < 30 nmol/L) and plasma uroporphyrin was 2.0 µg/dL (normal, < 1.0  µg/dL). Her serum ferritin level was also high, at 420 ng/mL (normal, < 200 ng/mL).

Rebecca Karp Leaf, MD, of Massachusetts General Hospital and Harvard Medical School, diagnosed her with PCT, a disorder of heme biosynthesis that often presents with skin manifestations.

As co-founder and co-director of the Boston hospital’s Porphyria Center, Karp Leaf is a leading expert in PCT, a rare disease that affects 5-10 people per 100,000. In addition to speaking at the ASH meeting in December, she described PCT in a December 2024 article in Hematology: American Society of Hematology Education Program. 

PCT is caused by inhibition of an enzyme in heme biosynthesis and leads to accumulation of porphyrins in the liver and plasma, Karp Leaf said. Through a complex process, excess of iron leads to inhibition of the enzyme, which leads to a buildup of toxic porphyrins, she said. The condition causes painless, blistering lesions on sun-exposed skin, scarring, skin fragility, dark urine, and liver disease. 

PCT most commonly occurs in middle age after the age of 40 and affects men more than women. “It’s the only porphyria that can occur absent a genetic variant,” she said, and 75% of cases have no genetic component. 

 

Options for Treatment Include Antivirals and Phlebotomy

Risk factors for PCT include alcohol use, smoking, exogenous estrogen, hepatitis, and HIV mutations. 

In regard to treatment, “modification of risk factors can be variably helpful: alcohol and smoking cessation, stopping exogenous estrogen, sun-protective clothing, and steroid-containing creams for lesions,” Karp Leaf said. “Most patients typically require further therapy to reduce liver porphyrins.”

Urine and plasma tests can help with diagnosis, she said. In patients with hepatitis C (HCV), “direct-acting antivirals can actually lead to resolution of PCT without any other therapy. We suspect that with effective antiviral treatment for HCV, the incidence of PCT will really go down.”

Therapeutic phlebotomy — blood removal — is another option. “It’s one of my favorite therapies because you don’t have to give somebody a drug. You can just take out iron,” Karp Leaf said. “Typically, we’ll start with venesection of 450 ccs of whole blood every 2 weeks, We target a ferritin level of 20 [ng/mL] but permit it up to 50 [ng/mL], or a little bit higher.”

The treatment leads to resolution of blisters in about 2-3 months, she said, and normalization of porphyrins by 13 months. Patients typically require about 6-8 treatments, she said. 

Another option is iron chelation, iron removal via medicine, “but it’s expensive, has side effects, and is really not recommended if other treatments are available,” she said. 

 

Hydroxychloroquine Can Be Helpful Too

Low-dose hydroxychloroquine can also be effective at 100 mg twice a week, “much lower than what we use in autoimmune disease,” Karp Leaf said. “We suspect that it’s taken up by the hepatic lysosomes and causes release of porphyrins. It causes clinical remission in about 6 months.”

However, higher doses can lead to liver injury, and the drug’s use is limited in end-stage kidney disease since porphyrins are excreted in the urine. These patients are especially difficult to treat, she said.

In the case of the 39-year-old patient, Karp Leaf recommended that the woman reduce her alcohol intake and begin using a copper intrauterine device for contraception instead of a combined oral contraceptive pill, which allowed her to undergo phlebotomy.

“She needed about eight sessions of therapeutic phlebotomy to achieve a ferritin of 30 [ng/mL], and her lesions resolved in 6 months,” Karp Leaf said. “Her plasma porphyrins resolved by 12 months. Her liver biochemistries were a bit elevated, and they subsequently normalized.”

Karp Leaf said she sees the patient about once a year. 

 

Hemochromatosis: It’s (Probably) a Family Affair

In an adjoining presentation at ASH and in a December 2024 article in Hematology: American Society of Hematology Education Program, hematologist Domenico Girelli, MD, PhD, with the University of Verona, Italy, told colleagues about the 56-year-old male patient with fatigue. He also had a mildly enlarged liver, hyperferritinemia (890  µg/L vs normal value < 300 µg/L) and a mildly increased alanine aminotransferase level (46 U/L vs normal value < 40 U/L).

The patient was diagnosed with hemochromatosis, a genetic disorder caused by mutations that leads to increased transferrin saturation, Girelli said. 

“By definition, hemochromatosis is characterized by the absence of signs of a primary red blood cell disorder — different from other disorders like transfusion iron overload or iron-loading anemias,” he said. 

It’s also important to consider other possible causes of hyperferritinemia, because most cases of the symptom aren’t related to iron overload, he said. “A careful clinical history and a few laboratory parameters including transferrin saturation are generally sufficient for the differential diagnosis.”

As Girelli noted, “hemochromatosis can have a wide clinical spectrum ranging from mild to severe forms, which are strongly influenced by the co-presence of risk factors like alcohol [use], blood transfusion, and genetic factors captured by polygenic risk score.”

 

In Many Cases, Hemochromatosis Can Be Successfully Treated

According to Girelli, it’s important to understand the disease stage, because this information can predict the probability of advanced liver fibrosis, which can be a sign of a worse prognosis.

“The strongest clinical predictors of advanced liver fibrosis are ferritin higher than 1000 [µg/L] and the presence of arthropathy [joint disease],” he said. “If both are absent and the patient is asymptomatic, there is no need for further investigation. If both are present, further investigation — including cardiac MRI and full endocrine profile — are indicated. Liver biopsy may be indicated only in uncertain cases.”

Fortunately, “most patients are diagnosed in preclinical or early stage, and their prognosis is excellent, with a normal life expectancy,” he said 

Phlebotomy remains the standard of care for hemochromatosis in uncomplicated cases. “It is safe, cheap, well-tolerated, and significantly reduces mortality and morbidity, especially when it is started before the development of cirrhosis,” he said. 

 

Family Members Should Be Tested for Genetic Traits

It’s important to advise patients prior to phlebotomy to avoid undercooked seafood and wound contact with sea water because of the risk for sepsis due to the pathogen Vibrio vulnificus, Girelli said. 

And it’s a good idea to test family members to see if they share a genetic risk for hemochromatosis, he said. The 56-year-old patient’s brother turned out to also have genetic risk, and his iron levels were very high. He had recently been diagnosed with seronegative arthritis that could be classified as secondary to hemochromatosis.

For management, Girelli said, patients should minimize or avoid alcohol consumption, eat a healthy diet, and avoid vitamin C and iron supplements even in multivitamin compounds. Patients should be encouraged to exercise and maintain an ideal weight. 

The 56-year-old patient fared well, reaching a ferritin target of 50 mg/mL after multiple phlebotomy procedures that removed nearly 5 g of iron.

The patient tolerated the treatment and his fatigue resolved, Girelli said. “The maintenance treatment consisted of 3 phlebotomies per year. The patient remained asymptomatic and was eventually enrolled as a regular blood donor.”

Karp Leaf disclosed relationships with Alnylam, Recordati, and Disc Medicine. She is a member of the Porphyrias Consortium, part of the Rare Diseases Clinical Research Network, funded by the National Institutes of Health and led by the National Center for Advancing Translational Sciences (NCATS). The consortium is funded by NCATS and the National Institute of Diabetes and Digestive and Kidney Diseases. Girelli had no disclosures.

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

One patient, a 39-year-old woman, went to a dermatologist seeking care for fluid-filled blisters over the backs of her hands and arms. Another patient, a 56-year-old man, sought care from his general practitioner owing to fatigue.

Their presentations were quite different, but the two patients shared one thing in common: iron overload. Both ended up in the care of hematologists who diagnosed their conditions as porphyria cutanea tarda (PCT) and hemochromatosis, respectively.

A pair of hematologists discussed the treatment of these disorders at the American Society of Hematology (ASH) 2024 Annual Meeting and in reports in Hematology: American Society of Hematology Education Program. Here’s a look at the guidance they provided.

 

Porphyria Cutanea Tarda: Skin Trouble

Testing revealed that the female patient had a highly elevated porphyrin levels: Her urine uroporphyrin was 3959  nmol/L (normal, < 30 nmol/L) and plasma uroporphyrin was 2.0 µg/dL (normal, < 1.0  µg/dL). Her serum ferritin level was also high, at 420 ng/mL (normal, < 200 ng/mL).

Rebecca Karp Leaf, MD, of Massachusetts General Hospital and Harvard Medical School, diagnosed her with PCT, a disorder of heme biosynthesis that often presents with skin manifestations.

As co-founder and co-director of the Boston hospital’s Porphyria Center, Karp Leaf is a leading expert in PCT, a rare disease that affects 5-10 people per 100,000. In addition to speaking at the ASH meeting in December, she described PCT in a December 2024 article in Hematology: American Society of Hematology Education Program. 

PCT is caused by inhibition of an enzyme in heme biosynthesis and leads to accumulation of porphyrins in the liver and plasma, Karp Leaf said. Through a complex process, excess of iron leads to inhibition of the enzyme, which leads to a buildup of toxic porphyrins, she said. The condition causes painless, blistering lesions on sun-exposed skin, scarring, skin fragility, dark urine, and liver disease. 

PCT most commonly occurs in middle age after the age of 40 and affects men more than women. “It’s the only porphyria that can occur absent a genetic variant,” she said, and 75% of cases have no genetic component. 

 

Options for Treatment Include Antivirals and Phlebotomy

Risk factors for PCT include alcohol use, smoking, exogenous estrogen, hepatitis, and HIV mutations. 

In regard to treatment, “modification of risk factors can be variably helpful: alcohol and smoking cessation, stopping exogenous estrogen, sun-protective clothing, and steroid-containing creams for lesions,” Karp Leaf said. “Most patients typically require further therapy to reduce liver porphyrins.”

Urine and plasma tests can help with diagnosis, she said. In patients with hepatitis C (HCV), “direct-acting antivirals can actually lead to resolution of PCT without any other therapy. We suspect that with effective antiviral treatment for HCV, the incidence of PCT will really go down.”

Therapeutic phlebotomy — blood removal — is another option. “It’s one of my favorite therapies because you don’t have to give somebody a drug. You can just take out iron,” Karp Leaf said. “Typically, we’ll start with venesection of 450 ccs of whole blood every 2 weeks, We target a ferritin level of 20 [ng/mL] but permit it up to 50 [ng/mL], or a little bit higher.”

The treatment leads to resolution of blisters in about 2-3 months, she said, and normalization of porphyrins by 13 months. Patients typically require about 6-8 treatments, she said. 

Another option is iron chelation, iron removal via medicine, “but it’s expensive, has side effects, and is really not recommended if other treatments are available,” she said. 

 

Hydroxychloroquine Can Be Helpful Too

Low-dose hydroxychloroquine can also be effective at 100 mg twice a week, “much lower than what we use in autoimmune disease,” Karp Leaf said. “We suspect that it’s taken up by the hepatic lysosomes and causes release of porphyrins. It causes clinical remission in about 6 months.”

However, higher doses can lead to liver injury, and the drug’s use is limited in end-stage kidney disease since porphyrins are excreted in the urine. These patients are especially difficult to treat, she said.

In the case of the 39-year-old patient, Karp Leaf recommended that the woman reduce her alcohol intake and begin using a copper intrauterine device for contraception instead of a combined oral contraceptive pill, which allowed her to undergo phlebotomy.

“She needed about eight sessions of therapeutic phlebotomy to achieve a ferritin of 30 [ng/mL], and her lesions resolved in 6 months,” Karp Leaf said. “Her plasma porphyrins resolved by 12 months. Her liver biochemistries were a bit elevated, and they subsequently normalized.”

Karp Leaf said she sees the patient about once a year. 

 

Hemochromatosis: It’s (Probably) a Family Affair

In an adjoining presentation at ASH and in a December 2024 article in Hematology: American Society of Hematology Education Program, hematologist Domenico Girelli, MD, PhD, with the University of Verona, Italy, told colleagues about the 56-year-old male patient with fatigue. He also had a mildly enlarged liver, hyperferritinemia (890  µg/L vs normal value < 300 µg/L) and a mildly increased alanine aminotransferase level (46 U/L vs normal value < 40 U/L).

The patient was diagnosed with hemochromatosis, a genetic disorder caused by mutations that leads to increased transferrin saturation, Girelli said. 

“By definition, hemochromatosis is characterized by the absence of signs of a primary red blood cell disorder — different from other disorders like transfusion iron overload or iron-loading anemias,” he said. 

It’s also important to consider other possible causes of hyperferritinemia, because most cases of the symptom aren’t related to iron overload, he said. “A careful clinical history and a few laboratory parameters including transferrin saturation are generally sufficient for the differential diagnosis.”

As Girelli noted, “hemochromatosis can have a wide clinical spectrum ranging from mild to severe forms, which are strongly influenced by the co-presence of risk factors like alcohol [use], blood transfusion, and genetic factors captured by polygenic risk score.”

 

In Many Cases, Hemochromatosis Can Be Successfully Treated

According to Girelli, it’s important to understand the disease stage, because this information can predict the probability of advanced liver fibrosis, which can be a sign of a worse prognosis.

“The strongest clinical predictors of advanced liver fibrosis are ferritin higher than 1000 [µg/L] and the presence of arthropathy [joint disease],” he said. “If both are absent and the patient is asymptomatic, there is no need for further investigation. If both are present, further investigation — including cardiac MRI and full endocrine profile — are indicated. Liver biopsy may be indicated only in uncertain cases.”

Fortunately, “most patients are diagnosed in preclinical or early stage, and their prognosis is excellent, with a normal life expectancy,” he said 

Phlebotomy remains the standard of care for hemochromatosis in uncomplicated cases. “It is safe, cheap, well-tolerated, and significantly reduces mortality and morbidity, especially when it is started before the development of cirrhosis,” he said. 

 

Family Members Should Be Tested for Genetic Traits

It’s important to advise patients prior to phlebotomy to avoid undercooked seafood and wound contact with sea water because of the risk for sepsis due to the pathogen Vibrio vulnificus, Girelli said. 

And it’s a good idea to test family members to see if they share a genetic risk for hemochromatosis, he said. The 56-year-old patient’s brother turned out to also have genetic risk, and his iron levels were very high. He had recently been diagnosed with seronegative arthritis that could be classified as secondary to hemochromatosis.

For management, Girelli said, patients should minimize or avoid alcohol consumption, eat a healthy diet, and avoid vitamin C and iron supplements even in multivitamin compounds. Patients should be encouraged to exercise and maintain an ideal weight. 

The 56-year-old patient fared well, reaching a ferritin target of 50 mg/mL after multiple phlebotomy procedures that removed nearly 5 g of iron.

The patient tolerated the treatment and his fatigue resolved, Girelli said. “The maintenance treatment consisted of 3 phlebotomies per year. The patient remained asymptomatic and was eventually enrolled as a regular blood donor.”

Karp Leaf disclosed relationships with Alnylam, Recordati, and Disc Medicine. She is a member of the Porphyrias Consortium, part of the Rare Diseases Clinical Research Network, funded by the National Institutes of Health and led by the National Center for Advancing Translational Sciences (NCATS). The consortium is funded by NCATS and the National Institute of Diabetes and Digestive and Kidney Diseases. Girelli had no disclosures.

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

A noninvasive clinicopathologic and gene expression profiling (CP-GEP)–based tool, the Merlin assay, shows promise for identifying recurrence risks in patients with early-stage melanoma who do not undergo sentinel lymph node biopsy (SNLB).

This was the conclusion of a retrospective analysis of a large cohort of patients with stage I/II disease, reported by Teresa Amaral, MD, PhD, at the 11th World Congress of Melanoma and 21st European Association of Dermato-Oncology Congress 2025.

Of 930 patients included in the study, the assay identified 879 as having a low risk for recurrence and 51 as having high risk for recurrence. The overall 5-year recurrence-free survival (RFS), distant metastasis-free survival (DMFS) and melanoma-specific survival (MSS) rates were 90.9%, 96.9%, and 97.5%, respectively.

The corresponding rates among those stratified by the assay as having low vs high recurrence risk, respectively, were 94.6% and 26.6% for RFS (hazard ratio [HR], 25.08), 98.6% vs 62.1% for DMFS (HR, 35.39), and 99.4% vs 61.7% for MSS (HR, 71.05), said Amaral, during her presentation at the meeting.

Of 16 melanoma-specific deaths, 12 were stratified as high risk for recurrence by the CP-GEP assay, said Amaral, head of the Skin Cancer Clinical Trials Center at the University of Tübingen, Tübingen, Germany, and first author of the study.

Study participants had stages IA-IIC melanoma, 41% were women, and median age was 64 years. Median melanoma thickness was 0.5 mm, and 94% were not ulcerated. 

No systemic treatment options currently exist for patients with this early-stage disease, the author said.

The CP-GEP model, initially developed by the Mayo Clinic and SkylineDx BV to predict the positivity of SNLB, has been validated in multiple studies.

Amaral and her colleagues previously demonstrated the ability of the CP-GEP model to stratify patients with stages I-II disease as having low or high risk for recurrence — including in a small number of patients without SNLB. Those findings are confirmed in this larger population of patients who did not undergo SNLB, she said.

SkylineDx announced the findings in a press release stating the results validate the prognostic power of the Merlin assay for “identifying tumors at high risk for relapse that would otherwise be missed by traditional clinical and pathological evaluation.”

SNLB is the gold standard for nodal assessment for staging cutaneous melanoma. More than 80% of patients who undergo SNLB are negative for nodal metastases, but most patients who relapse or die from their melanoma are initially stratified by SNLB as having low-risk early-stage disease, Amaral explained. This suggests “SNLB is not enough,” she noted.

The findings suggest that CP-GEP has the potential to risk stratify patients with early-stage melanoma that did not undergo SLNB and help select those who can forgo SLNB, she said.

Without another means of assessing risk, patients considered low risk based on SNLB are closely followed, the author explained.

“If we could identify the very low-risk patient and then allocate the resources to the very high-risk patients who really need a more detailed and more tailored approach…we would be doing a favor to our patients,” the author concluded.

Amaral disclosed personal financial relationships with Delcath, Philogen, Bristol Myers Squibb, NeraCare, Novartis, Pierre Fabre, CeCaVa, and MedTrix.

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

A noninvasive clinicopathologic and gene expression profiling (CP-GEP)–based tool, the Merlin assay, shows promise for identifying recurrence risks in patients with early-stage melanoma who do not undergo sentinel lymph node biopsy (SNLB).

This was the conclusion of a retrospective analysis of a large cohort of patients with stage I/II disease, reported by Teresa Amaral, MD, PhD, at the 11th World Congress of Melanoma and 21st European Association of Dermato-Oncology Congress 2025.

Of 930 patients included in the study, the assay identified 879 as having a low risk for recurrence and 51 as having high risk for recurrence. The overall 5-year recurrence-free survival (RFS), distant metastasis-free survival (DMFS) and melanoma-specific survival (MSS) rates were 90.9%, 96.9%, and 97.5%, respectively.

The corresponding rates among those stratified by the assay as having low vs high recurrence risk, respectively, were 94.6% and 26.6% for RFS (hazard ratio [HR], 25.08), 98.6% vs 62.1% for DMFS (HR, 35.39), and 99.4% vs 61.7% for MSS (HR, 71.05), said Amaral, during her presentation at the meeting.

Of 16 melanoma-specific deaths, 12 were stratified as high risk for recurrence by the CP-GEP assay, said Amaral, head of the Skin Cancer Clinical Trials Center at the University of Tübingen, Tübingen, Germany, and first author of the study.

Study participants had stages IA-IIC melanoma, 41% were women, and median age was 64 years. Median melanoma thickness was 0.5 mm, and 94% were not ulcerated. 

No systemic treatment options currently exist for patients with this early-stage disease, the author said.

The CP-GEP model, initially developed by the Mayo Clinic and SkylineDx BV to predict the positivity of SNLB, has been validated in multiple studies.

Amaral and her colleagues previously demonstrated the ability of the CP-GEP model to stratify patients with stages I-II disease as having low or high risk for recurrence — including in a small number of patients without SNLB. Those findings are confirmed in this larger population of patients who did not undergo SNLB, she said.

SkylineDx announced the findings in a press release stating the results validate the prognostic power of the Merlin assay for “identifying tumors at high risk for relapse that would otherwise be missed by traditional clinical and pathological evaluation.”

SNLB is the gold standard for nodal assessment for staging cutaneous melanoma. More than 80% of patients who undergo SNLB are negative for nodal metastases, but most patients who relapse or die from their melanoma are initially stratified by SNLB as having low-risk early-stage disease, Amaral explained. This suggests “SNLB is not enough,” she noted.

The findings suggest that CP-GEP has the potential to risk stratify patients with early-stage melanoma that did not undergo SLNB and help select those who can forgo SLNB, she said.

Without another means of assessing risk, patients considered low risk based on SNLB are closely followed, the author explained.

“If we could identify the very low-risk patient and then allocate the resources to the very high-risk patients who really need a more detailed and more tailored approach…we would be doing a favor to our patients,” the author concluded.

Amaral disclosed personal financial relationships with Delcath, Philogen, Bristol Myers Squibb, NeraCare, Novartis, Pierre Fabre, CeCaVa, and MedTrix.

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

A noninvasive clinicopathologic and gene expression profiling (CP-GEP)–based tool, the Merlin assay, shows promise for identifying recurrence risks in patients with early-stage melanoma who do not undergo sentinel lymph node biopsy (SNLB).

This was the conclusion of a retrospective analysis of a large cohort of patients with stage I/II disease, reported by Teresa Amaral, MD, PhD, at the 11th World Congress of Melanoma and 21st European Association of Dermato-Oncology Congress 2025.

Of 930 patients included in the study, the assay identified 879 as having a low risk for recurrence and 51 as having high risk for recurrence. The overall 5-year recurrence-free survival (RFS), distant metastasis-free survival (DMFS) and melanoma-specific survival (MSS) rates were 90.9%, 96.9%, and 97.5%, respectively.

The corresponding rates among those stratified by the assay as having low vs high recurrence risk, respectively, were 94.6% and 26.6% for RFS (hazard ratio [HR], 25.08), 98.6% vs 62.1% for DMFS (HR, 35.39), and 99.4% vs 61.7% for MSS (HR, 71.05), said Amaral, during her presentation at the meeting.

Of 16 melanoma-specific deaths, 12 were stratified as high risk for recurrence by the CP-GEP assay, said Amaral, head of the Skin Cancer Clinical Trials Center at the University of Tübingen, Tübingen, Germany, and first author of the study.

Study participants had stages IA-IIC melanoma, 41% were women, and median age was 64 years. Median melanoma thickness was 0.5 mm, and 94% were not ulcerated. 

No systemic treatment options currently exist for patients with this early-stage disease, the author said.

The CP-GEP model, initially developed by the Mayo Clinic and SkylineDx BV to predict the positivity of SNLB, has been validated in multiple studies.

Amaral and her colleagues previously demonstrated the ability of the CP-GEP model to stratify patients with stages I-II disease as having low or high risk for recurrence — including in a small number of patients without SNLB. Those findings are confirmed in this larger population of patients who did not undergo SNLB, she said.

SkylineDx announced the findings in a press release stating the results validate the prognostic power of the Merlin assay for “identifying tumors at high risk for relapse that would otherwise be missed by traditional clinical and pathological evaluation.”

SNLB is the gold standard for nodal assessment for staging cutaneous melanoma. More than 80% of patients who undergo SNLB are negative for nodal metastases, but most patients who relapse or die from their melanoma are initially stratified by SNLB as having low-risk early-stage disease, Amaral explained. This suggests “SNLB is not enough,” she noted.

The findings suggest that CP-GEP has the potential to risk stratify patients with early-stage melanoma that did not undergo SLNB and help select those who can forgo SLNB, she said.

Without another means of assessing risk, patients considered low risk based on SNLB are closely followed, the author explained.

“If we could identify the very low-risk patient and then allocate the resources to the very high-risk patients who really need a more detailed and more tailored approach…we would be doing a favor to our patients,” the author concluded.

Amaral disclosed personal financial relationships with Delcath, Philogen, Bristol Myers Squibb, NeraCare, Novartis, Pierre Fabre, CeCaVa, and MedTrix.

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

Whatever’s ailing you, a vacation might just be the cure. Yes, getting away can improve your health, according to research published in in 2023. It might help combat symptoms of aging, suggested a 2024 study in Journal of Travel Research. But it could also have even more powerful psychological and physical benefits, transforming your life before you pack a bag and long after you return home.

This news organization spoke with two healthcare professionals who believe in the healing power of travel. They shared which personal “diagnoses” they have successfully treated with faraway places and how this therapy might work for you.

Stacey Funt, MD, NBC-HWC, a radiologist at Northwell Health in Long Island, New York, started the boutique wellness adventure travel company, LH Adventure Travel, in 2023. Funt curates and leads small groups to destinations like Peru, Guatemala, Morocco, and Italy. Each tour incorporates tenets of lifestyle medicine, including healthy eating, movement, stress management, and community building.

Kiya Thompson, RN, a surgical trauma nurse for 20 years, was similarly inspired to share her passion for travel. She is now a certified family travel coach who helps parents plan meaningful trips through her company, LuckyBucky, LLC.



Dx: Self-Esteem Deficiency / Rx: Vivaldi in Venice

In June 2015, Thompson found herself at an all-time low. As a nurse, she felt confident that she was “built for the adrenaline rush and could take on anything.” But outside the trauma center, Thompson felt inadequate, her self-esteem eroded by years of abusive relationships. “The daily hardships of my personal life, combined with the mental fortitude it took to endure the demands of caring for the sickest of the sick, were incredibly weighty,” she recalled. 

To escape, Thompson booked her first solo trip: 3 weeks in Italy. But days after she arrived, she felt the need to “escape her escape.” On a bus in Naples, she was pick-pocketed. The man she had been dating before her trip stopped responding to her messages. In her hotel room in Venice, she felt “lost, alone, and helpless.”

One evening, Thompson attended a small orchestral performance of Vivaldi’s “The Four Seasons” in a centuries-old church. The music triggered memories of her Italian grandparents at whose home she’d listened to the same piece.

“A switch flipped, and I changed my whole outlook,” she remembers.

During the concert, she reflected on strangers who had shown her kindness and care. A Canadian man who gave her €50 after her wallet was stolen. A friend-of-a-friend who showed her around Rome. The clerk at her Venice hotel who had offered her a hug.

“In the wake of experiencing the worst of people, I’d experienced so much more of the best of people; strangers who were willing to go above and beyond to help me,” Thompson said.

When Thompson returned home, she brought her new mindset along. “ My ability to problem-solve my way through a solo trip that presented unexpected hardships empowered me,” she explained. “I learned I was much more capable than I’d thought.”



Dx: Wilderness Phobia / Rx: A Safari in Tanzania

On an evening in the mid-1990s, Funt was alone in a tent on a budget camping safari in Tanzania. Animals roared threateningly outside the thin walls. Earlier that day, a vulture had ripped a sandwich out of her hands. Funt was frightened to the core. Worrying that she’d be the next meal for the local wildlife, she started to sob. “This was as raw as I had ever gotten at that point in my life,” she said.

Suddenly, Funt said her brain shifted into problem-solving mode. She made one small decision: To switch to a different Jeep for the next day’s excursion. Having made a seemingly insignificant choice, she felt calmer and no longer like a victim. It brought control. Instead of worrying, she began looking forward to the wildlife she would see.

In the morning, in the new Jeep, she befriended a nurse from Canada. Together, they visited the Maasai Mara tribe and nearby pubs, meeting members of the community.

“It was the most exciting experience of my life,” Funt said. “And it had started with me crying.”



Dx: Parenting-itis / Rx: A Mountain Getaway 

As Thompson pointed out, sometimes the destination is secondary to the intension behind a trip. And the quality of the time away matters more than how long you can stay. After becoming parents 4 years ago, Thompson and her husband hadn’t traveled alone together. Like many parents of young children, they were short on time to relax and reconnect as a couple.

So Thompson planned a weekend trip to an isolated cabin in the Massanutten Mountain Range within the George Washington National Forest, about a 2-hour drive from their Washington, DC, area home.

“We put our devices away and focused on being completely present with one another,” said Thompson. The couple took a walk in the woods, where “all we could hear were drops of water from the snowmelt, the crunch of the snow beneath our feet, and the occasional bird looking for food,” she recalled. “There were no cars, no other people. It was quiet, calm, and incredibly peaceful.”

Whether sitting by the fire, soaking in the outdoor hot tub, or playing card games, “our conversation didn’t surround what we’d have for dinner or who would do baths and bedtime with whom,” Thompson said. “We didn’t talk about work, upcoming commitments, or items on our to-do lists.” The getaway was so refreshing, the couple intend to repeat the trip each year.



Dx: Persistent Grief / Rx: Hiking and Hinduism in Nepal

Nearly 3 years ago, Funt experienced a 2-month period where both of her kids left for college and both her father and father-in-law passed away. Besieged by grief, she found herself questioning whether her best years were behind her. She was also grappling with her mortality, because she was then approaching 59, the age at which her own mother had died. So Funt decided to go trekking in Nepal. “I am a traveler — it’s what I do,” she said.

Having the trip to prepare for changed Funt’s whole outlook, she remembers. Throwing herself into the planning helped her transcend her grief. But being in Nepal was even more impactful. She and her husband spent hours trekking through majestic mountain ranges, which “touched their souls.” At a crematorium, they learned about Hindu beliefs on death, which helped them with the grieving process.

The trip “lifted me so high up on so many levels and brought me back to my authentic self,” Funt said. On her flight home from Kathmandu, she decided to start her travel business.

“I needed something else [in addition to radiology] to put my passion, heart, and creativity into, and it would be another way of doing service,” she explained.



Dx: Couch Potato Syndrome / Rx: Planning an Adventure 

Like all of us, Funt knows exercise is important for health. But that knowledge alone doesn’t motivate her to move, she admitted. What does get her off the couch is scheduling an active trip — and then training for it. “When I have a goal tied to my values of adventure, connection, and community, fear will set in if I don’t start to move,” she said. It was after booking her Nepal trip (which included an 8-mile, 3000-foot trek) that Funt started getting in shape.

Travel has motivated Funt’s clients in similar ways. Last year, 8 months before one of her Morocco trips, Funt spoke over Zoom with a woman who’d just enrolled. This woman told her she’d signed up in order to commit to her health.

By the time Funt saw her again, on day 1 of the trip, the woman had lost 50 pounds. “It was the greatest transformation,” Funt recalled. “On the trip, she was the first one up the mountain and beamed the whole time. It was beautiful to watch her reclaim her power, body, and life.”

 

Getting Lost — Finding Inspiration

Since Thompson’s trip to Italy, she has traveled extensively, visiting nearly 25 countries. “Traveling inspired me to continue exploring the world and myself,” she said.

Since leading her first trip to Morocco in 2023, Funt said she’s received more letters of appreciation from her clients than her patients. The results from this type of travel therapy can be dramatic.

After a trip with Funt, one burned-out physician decided that she needed to find a job with a better work-life balance. An empty nester realized the “feeling of belonging and community” on the trip was what had been missing in her “regular” life. After returning home, she began rekindling relationships with old friends.

To many, a vacation is a treat. But, as Funt and Thompson have learned firsthand, it can also be a prescription — for ennui, sadness, loneliness, and all the physical issues that come with them. Sometimes, going far away helps you come home to yourself.

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

Whatever’s ailing you, a vacation might just be the cure. Yes, getting away can improve your health, according to research published in in 2023. It might help combat symptoms of aging, suggested a 2024 study in Journal of Travel Research. But it could also have even more powerful psychological and physical benefits, transforming your life before you pack a bag and long after you return home.

This news organization spoke with two healthcare professionals who believe in the healing power of travel. They shared which personal “diagnoses” they have successfully treated with faraway places and how this therapy might work for you.

Stacey Funt, MD, NBC-HWC, a radiologist at Northwell Health in Long Island, New York, started the boutique wellness adventure travel company, LH Adventure Travel, in 2023. Funt curates and leads small groups to destinations like Peru, Guatemala, Morocco, and Italy. Each tour incorporates tenets of lifestyle medicine, including healthy eating, movement, stress management, and community building.

Kiya Thompson, RN, a surgical trauma nurse for 20 years, was similarly inspired to share her passion for travel. She is now a certified family travel coach who helps parents plan meaningful trips through her company, LuckyBucky, LLC.



Dx: Self-Esteem Deficiency / Rx: Vivaldi in Venice

In June 2015, Thompson found herself at an all-time low. As a nurse, she felt confident that she was “built for the adrenaline rush and could take on anything.” But outside the trauma center, Thompson felt inadequate, her self-esteem eroded by years of abusive relationships. “The daily hardships of my personal life, combined with the mental fortitude it took to endure the demands of caring for the sickest of the sick, were incredibly weighty,” she recalled. 

To escape, Thompson booked her first solo trip: 3 weeks in Italy. But days after she arrived, she felt the need to “escape her escape.” On a bus in Naples, she was pick-pocketed. The man she had been dating before her trip stopped responding to her messages. In her hotel room in Venice, she felt “lost, alone, and helpless.”

One evening, Thompson attended a small orchestral performance of Vivaldi’s “The Four Seasons” in a centuries-old church. The music triggered memories of her Italian grandparents at whose home she’d listened to the same piece.

“A switch flipped, and I changed my whole outlook,” she remembers.

During the concert, she reflected on strangers who had shown her kindness and care. A Canadian man who gave her €50 after her wallet was stolen. A friend-of-a-friend who showed her around Rome. The clerk at her Venice hotel who had offered her a hug.

“In the wake of experiencing the worst of people, I’d experienced so much more of the best of people; strangers who were willing to go above and beyond to help me,” Thompson said.

When Thompson returned home, she brought her new mindset along. “ My ability to problem-solve my way through a solo trip that presented unexpected hardships empowered me,” she explained. “I learned I was much more capable than I’d thought.”



Dx: Wilderness Phobia / Rx: A Safari in Tanzania

On an evening in the mid-1990s, Funt was alone in a tent on a budget camping safari in Tanzania. Animals roared threateningly outside the thin walls. Earlier that day, a vulture had ripped a sandwich out of her hands. Funt was frightened to the core. Worrying that she’d be the next meal for the local wildlife, she started to sob. “This was as raw as I had ever gotten at that point in my life,” she said.

Suddenly, Funt said her brain shifted into problem-solving mode. She made one small decision: To switch to a different Jeep for the next day’s excursion. Having made a seemingly insignificant choice, she felt calmer and no longer like a victim. It brought control. Instead of worrying, she began looking forward to the wildlife she would see.

In the morning, in the new Jeep, she befriended a nurse from Canada. Together, they visited the Maasai Mara tribe and nearby pubs, meeting members of the community.

“It was the most exciting experience of my life,” Funt said. “And it had started with me crying.”



Dx: Parenting-itis / Rx: A Mountain Getaway 

As Thompson pointed out, sometimes the destination is secondary to the intension behind a trip. And the quality of the time away matters more than how long you can stay. After becoming parents 4 years ago, Thompson and her husband hadn’t traveled alone together. Like many parents of young children, they were short on time to relax and reconnect as a couple.

So Thompson planned a weekend trip to an isolated cabin in the Massanutten Mountain Range within the George Washington National Forest, about a 2-hour drive from their Washington, DC, area home.

“We put our devices away and focused on being completely present with one another,” said Thompson. The couple took a walk in the woods, where “all we could hear were drops of water from the snowmelt, the crunch of the snow beneath our feet, and the occasional bird looking for food,” she recalled. “There were no cars, no other people. It was quiet, calm, and incredibly peaceful.”

Whether sitting by the fire, soaking in the outdoor hot tub, or playing card games, “our conversation didn’t surround what we’d have for dinner or who would do baths and bedtime with whom,” Thompson said. “We didn’t talk about work, upcoming commitments, or items on our to-do lists.” The getaway was so refreshing, the couple intend to repeat the trip each year.



Dx: Persistent Grief / Rx: Hiking and Hinduism in Nepal

Nearly 3 years ago, Funt experienced a 2-month period where both of her kids left for college and both her father and father-in-law passed away. Besieged by grief, she found herself questioning whether her best years were behind her. She was also grappling with her mortality, because she was then approaching 59, the age at which her own mother had died. So Funt decided to go trekking in Nepal. “I am a traveler — it’s what I do,” she said.

Having the trip to prepare for changed Funt’s whole outlook, she remembers. Throwing herself into the planning helped her transcend her grief. But being in Nepal was even more impactful. She and her husband spent hours trekking through majestic mountain ranges, which “touched their souls.” At a crematorium, they learned about Hindu beliefs on death, which helped them with the grieving process.

The trip “lifted me so high up on so many levels and brought me back to my authentic self,” Funt said. On her flight home from Kathmandu, she decided to start her travel business.

“I needed something else [in addition to radiology] to put my passion, heart, and creativity into, and it would be another way of doing service,” she explained.



Dx: Couch Potato Syndrome / Rx: Planning an Adventure 

Like all of us, Funt knows exercise is important for health. But that knowledge alone doesn’t motivate her to move, she admitted. What does get her off the couch is scheduling an active trip — and then training for it. “When I have a goal tied to my values of adventure, connection, and community, fear will set in if I don’t start to move,” she said. It was after booking her Nepal trip (which included an 8-mile, 3000-foot trek) that Funt started getting in shape.

Travel has motivated Funt’s clients in similar ways. Last year, 8 months before one of her Morocco trips, Funt spoke over Zoom with a woman who’d just enrolled. This woman told her she’d signed up in order to commit to her health.

By the time Funt saw her again, on day 1 of the trip, the woman had lost 50 pounds. “It was the greatest transformation,” Funt recalled. “On the trip, she was the first one up the mountain and beamed the whole time. It was beautiful to watch her reclaim her power, body, and life.”

 

Getting Lost — Finding Inspiration

Since Thompson’s trip to Italy, she has traveled extensively, visiting nearly 25 countries. “Traveling inspired me to continue exploring the world and myself,” she said.

Since leading her first trip to Morocco in 2023, Funt said she’s received more letters of appreciation from her clients than her patients. The results from this type of travel therapy can be dramatic.

After a trip with Funt, one burned-out physician decided that she needed to find a job with a better work-life balance. An empty nester realized the “feeling of belonging and community” on the trip was what had been missing in her “regular” life. After returning home, she began rekindling relationships with old friends.

To many, a vacation is a treat. But, as Funt and Thompson have learned firsthand, it can also be a prescription — for ennui, sadness, loneliness, and all the physical issues that come with them. Sometimes, going far away helps you come home to yourself.

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

Whatever’s ailing you, a vacation might just be the cure. Yes, getting away can improve your health, according to research published in in 2023. It might help combat symptoms of aging, suggested a 2024 study in Journal of Travel Research. But it could also have even more powerful psychological and physical benefits, transforming your life before you pack a bag and long after you return home.

This news organization spoke with two healthcare professionals who believe in the healing power of travel. They shared which personal “diagnoses” they have successfully treated with faraway places and how this therapy might work for you.

Stacey Funt, MD, NBC-HWC, a radiologist at Northwell Health in Long Island, New York, started the boutique wellness adventure travel company, LH Adventure Travel, in 2023. Funt curates and leads small groups to destinations like Peru, Guatemala, Morocco, and Italy. Each tour incorporates tenets of lifestyle medicine, including healthy eating, movement, stress management, and community building.

Kiya Thompson, RN, a surgical trauma nurse for 20 years, was similarly inspired to share her passion for travel. She is now a certified family travel coach who helps parents plan meaningful trips through her company, LuckyBucky, LLC.



Dx: Self-Esteem Deficiency / Rx: Vivaldi in Venice

In June 2015, Thompson found herself at an all-time low. As a nurse, she felt confident that she was “built for the adrenaline rush and could take on anything.” But outside the trauma center, Thompson felt inadequate, her self-esteem eroded by years of abusive relationships. “The daily hardships of my personal life, combined with the mental fortitude it took to endure the demands of caring for the sickest of the sick, were incredibly weighty,” she recalled. 

To escape, Thompson booked her first solo trip: 3 weeks in Italy. But days after she arrived, she felt the need to “escape her escape.” On a bus in Naples, she was pick-pocketed. The man she had been dating before her trip stopped responding to her messages. In her hotel room in Venice, she felt “lost, alone, and helpless.”

One evening, Thompson attended a small orchestral performance of Vivaldi’s “The Four Seasons” in a centuries-old church. The music triggered memories of her Italian grandparents at whose home she’d listened to the same piece.

“A switch flipped, and I changed my whole outlook,” she remembers.

During the concert, she reflected on strangers who had shown her kindness and care. A Canadian man who gave her €50 after her wallet was stolen. A friend-of-a-friend who showed her around Rome. The clerk at her Venice hotel who had offered her a hug.

“In the wake of experiencing the worst of people, I’d experienced so much more of the best of people; strangers who were willing to go above and beyond to help me,” Thompson said.

When Thompson returned home, she brought her new mindset along. “ My ability to problem-solve my way through a solo trip that presented unexpected hardships empowered me,” she explained. “I learned I was much more capable than I’d thought.”



Dx: Wilderness Phobia / Rx: A Safari in Tanzania

On an evening in the mid-1990s, Funt was alone in a tent on a budget camping safari in Tanzania. Animals roared threateningly outside the thin walls. Earlier that day, a vulture had ripped a sandwich out of her hands. Funt was frightened to the core. Worrying that she’d be the next meal for the local wildlife, she started to sob. “This was as raw as I had ever gotten at that point in my life,” she said.

Suddenly, Funt said her brain shifted into problem-solving mode. She made one small decision: To switch to a different Jeep for the next day’s excursion. Having made a seemingly insignificant choice, she felt calmer and no longer like a victim. It brought control. Instead of worrying, she began looking forward to the wildlife she would see.

In the morning, in the new Jeep, she befriended a nurse from Canada. Together, they visited the Maasai Mara tribe and nearby pubs, meeting members of the community.

“It was the most exciting experience of my life,” Funt said. “And it had started with me crying.”



Dx: Parenting-itis / Rx: A Mountain Getaway 

As Thompson pointed out, sometimes the destination is secondary to the intension behind a trip. And the quality of the time away matters more than how long you can stay. After becoming parents 4 years ago, Thompson and her husband hadn’t traveled alone together. Like many parents of young children, they were short on time to relax and reconnect as a couple.

So Thompson planned a weekend trip to an isolated cabin in the Massanutten Mountain Range within the George Washington National Forest, about a 2-hour drive from their Washington, DC, area home.

“We put our devices away and focused on being completely present with one another,” said Thompson. The couple took a walk in the woods, where “all we could hear were drops of water from the snowmelt, the crunch of the snow beneath our feet, and the occasional bird looking for food,” she recalled. “There were no cars, no other people. It was quiet, calm, and incredibly peaceful.”

Whether sitting by the fire, soaking in the outdoor hot tub, or playing card games, “our conversation didn’t surround what we’d have for dinner or who would do baths and bedtime with whom,” Thompson said. “We didn’t talk about work, upcoming commitments, or items on our to-do lists.” The getaway was so refreshing, the couple intend to repeat the trip each year.



Dx: Persistent Grief / Rx: Hiking and Hinduism in Nepal

Nearly 3 years ago, Funt experienced a 2-month period where both of her kids left for college and both her father and father-in-law passed away. Besieged by grief, she found herself questioning whether her best years were behind her. She was also grappling with her mortality, because she was then approaching 59, the age at which her own mother had died. So Funt decided to go trekking in Nepal. “I am a traveler — it’s what I do,” she said.

Having the trip to prepare for changed Funt’s whole outlook, she remembers. Throwing herself into the planning helped her transcend her grief. But being in Nepal was even more impactful. She and her husband spent hours trekking through majestic mountain ranges, which “touched their souls.” At a crematorium, they learned about Hindu beliefs on death, which helped them with the grieving process.

The trip “lifted me so high up on so many levels and brought me back to my authentic self,” Funt said. On her flight home from Kathmandu, she decided to start her travel business.

“I needed something else [in addition to radiology] to put my passion, heart, and creativity into, and it would be another way of doing service,” she explained.



Dx: Couch Potato Syndrome / Rx: Planning an Adventure 

Like all of us, Funt knows exercise is important for health. But that knowledge alone doesn’t motivate her to move, she admitted. What does get her off the couch is scheduling an active trip — and then training for it. “When I have a goal tied to my values of adventure, connection, and community, fear will set in if I don’t start to move,” she said. It was after booking her Nepal trip (which included an 8-mile, 3000-foot trek) that Funt started getting in shape.

Travel has motivated Funt’s clients in similar ways. Last year, 8 months before one of her Morocco trips, Funt spoke over Zoom with a woman who’d just enrolled. This woman told her she’d signed up in order to commit to her health.

By the time Funt saw her again, on day 1 of the trip, the woman had lost 50 pounds. “It was the greatest transformation,” Funt recalled. “On the trip, she was the first one up the mountain and beamed the whole time. It was beautiful to watch her reclaim her power, body, and life.”

 

Getting Lost — Finding Inspiration

Since Thompson’s trip to Italy, she has traveled extensively, visiting nearly 25 countries. “Traveling inspired me to continue exploring the world and myself,” she said.

Since leading her first trip to Morocco in 2023, Funt said she’s received more letters of appreciation from her clients than her patients. The results from this type of travel therapy can be dramatic.

After a trip with Funt, one burned-out physician decided that she needed to find a job with a better work-life balance. An empty nester realized the “feeling of belonging and community” on the trip was what had been missing in her “regular” life. After returning home, she began rekindling relationships with old friends.

To many, a vacation is a treat. But, as Funt and Thompson have learned firsthand, it can also be a prescription — for ennui, sadness, loneliness, and all the physical issues that come with them. Sometimes, going far away helps you come home to yourself.

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

On March 27, Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. said he planned to cut about 10,000 full-time jobs from the department in a sweeping “reorganization.” Less than a week later, the reduction in force (RIF) notifications were sent out, and in the very early hours of April 1, hundreds of employees found themselves locked out from their offices, often so abruptly their belongings were left behind. 

Most affected employees were told they would be placed on administrative leave; some were told to continue working until they can hand off their duties but they would be formally separated on June 2. Many of the email RIF notifications used the recommended wording provided by the US Office of Personnel Management: “This RIF action does not reflect directly on your service, performance, or conduct.” The HHS workforce is expected to be reduced from 82,000 full-time employees to 62,000. 

"The Trump Administration has launched an unprecedented attack on the federal health workforce," said House Energy and Commerce Committee Ranking Member Frank Pallone, Jr. (D-NJ), during an oversight and investigations hearing on medical device technology and cybersecurity.

The cuts in personnel and programs are broad and deep, and touch every aspect of public health. Alzheimer’s disease programs are being eliminated, measles vaccine clinics are being shuttered, and tuberculosis, HIV prevention, and cancer research are being stalled. A Reddit thread for RIF notices from HHS employees had nearly 750 postings, suggesting a broad cross-section of individuals and departments had received them. 

Secretary Kennedy stated the layoffs and restructuring will save $1.8 billion a year. “We aren’t just reducing bureaucratic sprawl," he said in a statement. "We are realigning the organization with its core mission and our new priorities in reversing the chronic disease epidemic.” On the social platform X, Kennedy acknowledged, “This will be a painful period for HHS.”

Entire offices devoted to Freedom of Information Act-related requests, communications, and human resources were also shut down, according to multiple reports.

The agency's 28 divisions will be reformatted into a “new, unified entity” of 15 divisions—the Administration for a Healthy America, or AHA, aimed at carrying out Kennedy's “Make America Healthy Again” agenda. The AHA will include the Substance Abuse and Mental Health Services Administration (SAMHSA), the Agency for Toxic Substances and Disease Registry, and the National Institute for Occupational Safety and Health. The Administration for Community Living's functions will shift into the Centers for Medicare and Medicaid Services, the Administration for Children and Families, and the Assistant Secretary for Planning and Evaluation (ASPE). ASPE will be combined with the Agency for Health Research and Quality into the Office of Strategy

 “This centralization,” HHS says, “will improve coordination of health resources for low-income Americans and will focus on areas including, Primary Care, Maternal and Child Health, Mental Health, Environmental Health, HIV/AIDS, and Workforce development.”

US Food and Drug Administration

An estimated 3500 full-time FDA employees are expected to receive RIF notices. The agency said reductions will not affect drug, medical device, or food reviewers or inspectors. 

Politico spoke with fired employees on condition of anonymity. According to them, Dr. Peter Stein, director of the FDA Office of New Drugs (OND), was let go. The policy office inside of OND was also eliminated. Another top FDA regulator, Dr. Brian King, the director of the Center for Tobacco Products (CTP), was placed on administrative leave, according to an email sent to his staff and obtained by Politico. “I encourage you to hold your heads high and never compromise the guiding tenets that CTP has held dear since its inception,” King wrote in the email to his staff. “We obeyed the law. We followed the science. We told the truth.” 

Julie Tierney, who was recently elevated to acting director of the FDA Center for Biologics Evaluation and Research, according to an agency website, was also placed on administrative leave, according to 2 people familiar with the decision. The FDA Office of Strategic Programs, including its director, Sridhar Mantha, has been completely shuttered. Mantha cochaired the Artificial Intelligence (AI) Council at the Center for Drug Evaluation and Research (CDER), which helped develop policy around AI use in drug development and assisted the FDA in using AI internally.

Centers for Disease Control and Prevention

About 2400 CDC employees are expected to receive RIF notices. According to Government Executive, the National Institute for Occupational Safety and Health (NIOSH) sustained more than one-third of the cuts at CDC. About 80% of the 1100 employees at the institute were laid off, including its director and deputy director. An HHS letter to a labor union said about 185 NIOSH employees would be let go in just the Morgantown, W. Va., location. However, NIOSH is apparently slated to be part of the newly created AHA.

Other layoffs hit the National Center for Chronic Disease Prevention and Health Promotion; National Center for Injury Prevention and Control; the National Center for HIV, Viral Hepatitis, STD, and Tuberculosis Prevention; the Global Health Center; the National Center on Birth Defects and Developmental Disabilities; and the National Center for Environmental Health. Two sources familiar with the firings said the Office on Smoking and Health was eliminated. The Administration for Strategic Preparedness and Response, currently part of the US Public Health Service, will move to the CDC. 

A compensation program for employees who developed cancer due to radiation exposure while working for the federal government was also eliminated. Similarly, a national registry that tracks rates of cancer among firefighters was cut. One employee said NIOSH laid off veterinarians despite the bureau having laboratory animals that need care. 

National Institutes of Health 

NIH will lose 1200 employees, due to "centralizing” procurement, human resources, and communications across its 27 institutes and centers. According to the employees who spoke with Politico, scientists were also targeted, including National Institute of Nursing Research Director Shannon Zenk; National Institute of Child Health and Human Development Director Diana Bianchi; Emily Erbelding, who leads the Division of Microbiology and Infectious Diseases at National Institutes of Allergy and Infectious Diseases; and National Institute on Minority Health and Health Disparities Director Eliseo Pérez-Stable. National Institute of Allergy and Infectious Diseases Director Jeanne Marrazzo, who replaced Anthony Fauci, was also put on leave.

In his “welcome” email to staff, the new NIH director, Dr. Jay Bhattacharya, wrote: “I recognize that I am joining NIH at a time of tremendous change. Every inch of the federal government is under scrutiny—and NIH is not exempt. These reductions in the workforce will have a profound impact on key NIH administrative functions, including communications, legislative affairs, procurement, and human resources, and will require an entirely new approach to how we carry them out.”

Deep Cuts at Other HHS Agencies

As many as 500 to 600 people were let go at the Health Resource and Services Administration (HRSA). Its Bureau of Primary Health Care, which oversees the national network of health care centers that collectively provide care to 31 million people, was “severely impacted,” and the agency lost much of its regional staff, according to an article in Government Executive. “This will have an enormous impact on the program and viability of health centers,” an HRSA employee said. 

About 50% of the nearly 900 SAMHSA employees were laid off and its 10 regional offices were closed. SAMHSA will be “hamstrung for data,” according to an agency employee, who added contracts may be cut en masse due the departure of the contract management staff. They added that even if funding remains for the agency, the support systems for grantees were being decimated.

More than 800 people lost their jobs at the CDER, according to an official who was laid off; this part of the agency had around 6,000 employees before the cuts.

Indian Health Service

The IHS offers a rare bright spot. Although it was also in line for massive cuts, it has been spared, for now. According to a statement emailed to Native News Online, Secretary Kennedy said the Trump administration intends to prioritize the IHS.

“The Indian Health Service has always been treated as the redheaded stepchild at HHS,” Secretary Kennedy wrote. “My father often complained that IHS was chronically understaffed and underfunded. President Trump wants me to rectify this sad history. Indians suffer at the highest level of chronic disease of any demographic. IHS will be a priority over the next 4 years. President Trump wants me to end the chronic disease epidemic beginning in Indian country.”

March layoffs that had been announced for 1000 IHS employees were rescinded.

“We can confirm the layoffs were rescinded thanks at least in part to advocacy by the many Tribal organizations,” a spokesperson for the National Indian Health Board told Native News Online.

In fact, top career executives across the department are now being offered reassignments to the IHS, which employees must accept to keep their jobs. One executive who received the offer told Native News Online that no details on positions or location were provided, and they doubted that everyone who got such a notice would ultimately be matched to a suitable position. 

"Streamline the Agency"

The dramatic actions at HHS were not unexpected. In fact, employees had been in an unsettling limbo since Kennedy was appointed Secretary, not knowing when the axe would fall, or where, or on whom. Kennedy, when describing the restructuring plans, said, “We're going to streamline our agency and eliminate the redundancies and invite everyone to align behind a simple, bold mission. I want every HHS employee to wake up every morning asking themselves, ‘What can I do to restore American Health?’ I want to empower everyone in the HHS family to have a sense of purpose and pride and a sense of personal agency and responsibility to this larger goal.”

“The FDA as we've known it is finished,” Dr. Robert M. Califf, who served as FDA commissioner twice, wrote on LinkedIn. In an interview with CNN, Califf said he was dismayed to see how federal workers were being treated. 

“This is a sad and inhumane way to treat people,” he said. “It’s different when you’re a company and you’re out of money and you can’t pay people, but the federal government can pay people and do things in an orderly, respectful fashion—and not have them end up in line trying to get to work and have their badges not work as a way to fire them.” 

But the fired HHS employees aren’t the only ones who will bear the brunt of the cuts. “Today’s announcement is not just a restructuring of the Department of Health and Human Services. It is a catastrophe for the health care of every American,” Senator Ed Markey (D-MA) said in a press briefing.

Calling the cuts “a recipe for disaster,” former CDC director Tom Frieden said, “[Secretary] Kennedy claims that health care services will not be harmed by the dramatic downsizing, but he is wrong, and everyone who is paying any attention knows it.”

Senators Bill Cassidy (R-LA) and Bernie Sanders (I-VT), of the Senate Health, Education, Labor, and Pensions Committee, announced Tuesday that they were inviting Kennedy to a hearing April 10 about the restructuring of HHS. “This will be a good opportunity,” Cassidy said in a statement, “for him to set the record straight and speak to the goals, structure and benefits of the proposed reorganization.”

On March 27, Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. said he planned to cut about 10,000 full-time jobs from the department in a sweeping “reorganization.” Less than a week later, the reduction in force (RIF) notifications were sent out, and in the very early hours of April 1, hundreds of employees found themselves locked out from their offices, often so abruptly their belongings were left behind. 

Most affected employees were told they would be placed on administrative leave; some were told to continue working until they can hand off their duties but they would be formally separated on June 2. Many of the email RIF notifications used the recommended wording provided by the US Office of Personnel Management: “This RIF action does not reflect directly on your service, performance, or conduct.” The HHS workforce is expected to be reduced from 82,000 full-time employees to 62,000. 

"The Trump Administration has launched an unprecedented attack on the federal health workforce," said House Energy and Commerce Committee Ranking Member Frank Pallone, Jr. (D-NJ), during an oversight and investigations hearing on medical device technology and cybersecurity.

The cuts in personnel and programs are broad and deep, and touch every aspect of public health. Alzheimer’s disease programs are being eliminated, measles vaccine clinics are being shuttered, and tuberculosis, HIV prevention, and cancer research are being stalled. A Reddit thread for RIF notices from HHS employees had nearly 750 postings, suggesting a broad cross-section of individuals and departments had received them. 

Secretary Kennedy stated the layoffs and restructuring will save $1.8 billion a year. “We aren’t just reducing bureaucratic sprawl," he said in a statement. "We are realigning the organization with its core mission and our new priorities in reversing the chronic disease epidemic.” On the social platform X, Kennedy acknowledged, “This will be a painful period for HHS.”

Entire offices devoted to Freedom of Information Act-related requests, communications, and human resources were also shut down, according to multiple reports.

The agency's 28 divisions will be reformatted into a “new, unified entity” of 15 divisions—the Administration for a Healthy America, or AHA, aimed at carrying out Kennedy's “Make America Healthy Again” agenda. The AHA will include the Substance Abuse and Mental Health Services Administration (SAMHSA), the Agency for Toxic Substances and Disease Registry, and the National Institute for Occupational Safety and Health. The Administration for Community Living's functions will shift into the Centers for Medicare and Medicaid Services, the Administration for Children and Families, and the Assistant Secretary for Planning and Evaluation (ASPE). ASPE will be combined with the Agency for Health Research and Quality into the Office of Strategy

 “This centralization,” HHS says, “will improve coordination of health resources for low-income Americans and will focus on areas including, Primary Care, Maternal and Child Health, Mental Health, Environmental Health, HIV/AIDS, and Workforce development.”

US Food and Drug Administration

An estimated 3500 full-time FDA employees are expected to receive RIF notices. The agency said reductions will not affect drug, medical device, or food reviewers or inspectors. 

Politico spoke with fired employees on condition of anonymity. According to them, Dr. Peter Stein, director of the FDA Office of New Drugs (OND), was let go. The policy office inside of OND was also eliminated. Another top FDA regulator, Dr. Brian King, the director of the Center for Tobacco Products (CTP), was placed on administrative leave, according to an email sent to his staff and obtained by Politico. “I encourage you to hold your heads high and never compromise the guiding tenets that CTP has held dear since its inception,” King wrote in the email to his staff. “We obeyed the law. We followed the science. We told the truth.” 

Julie Tierney, who was recently elevated to acting director of the FDA Center for Biologics Evaluation and Research, according to an agency website, was also placed on administrative leave, according to 2 people familiar with the decision. The FDA Office of Strategic Programs, including its director, Sridhar Mantha, has been completely shuttered. Mantha cochaired the Artificial Intelligence (AI) Council at the Center for Drug Evaluation and Research (CDER), which helped develop policy around AI use in drug development and assisted the FDA in using AI internally.

Centers for Disease Control and Prevention

About 2400 CDC employees are expected to receive RIF notices. According to Government Executive, the National Institute for Occupational Safety and Health (NIOSH) sustained more than one-third of the cuts at CDC. About 80% of the 1100 employees at the institute were laid off, including its director and deputy director. An HHS letter to a labor union said about 185 NIOSH employees would be let go in just the Morgantown, W. Va., location. However, NIOSH is apparently slated to be part of the newly created AHA.

Other layoffs hit the National Center for Chronic Disease Prevention and Health Promotion; National Center for Injury Prevention and Control; the National Center for HIV, Viral Hepatitis, STD, and Tuberculosis Prevention; the Global Health Center; the National Center on Birth Defects and Developmental Disabilities; and the National Center for Environmental Health. Two sources familiar with the firings said the Office on Smoking and Health was eliminated. The Administration for Strategic Preparedness and Response, currently part of the US Public Health Service, will move to the CDC. 

A compensation program for employees who developed cancer due to radiation exposure while working for the federal government was also eliminated. Similarly, a national registry that tracks rates of cancer among firefighters was cut. One employee said NIOSH laid off veterinarians despite the bureau having laboratory animals that need care. 

National Institutes of Health 

NIH will lose 1200 employees, due to "centralizing” procurement, human resources, and communications across its 27 institutes and centers. According to the employees who spoke with Politico, scientists were also targeted, including National Institute of Nursing Research Director Shannon Zenk; National Institute of Child Health and Human Development Director Diana Bianchi; Emily Erbelding, who leads the Division of Microbiology and Infectious Diseases at National Institutes of Allergy and Infectious Diseases; and National Institute on Minority Health and Health Disparities Director Eliseo Pérez-Stable. National Institute of Allergy and Infectious Diseases Director Jeanne Marrazzo, who replaced Anthony Fauci, was also put on leave.

In his “welcome” email to staff, the new NIH director, Dr. Jay Bhattacharya, wrote: “I recognize that I am joining NIH at a time of tremendous change. Every inch of the federal government is under scrutiny—and NIH is not exempt. These reductions in the workforce will have a profound impact on key NIH administrative functions, including communications, legislative affairs, procurement, and human resources, and will require an entirely new approach to how we carry them out.”

Deep Cuts at Other HHS Agencies

As many as 500 to 600 people were let go at the Health Resource and Services Administration (HRSA). Its Bureau of Primary Health Care, which oversees the national network of health care centers that collectively provide care to 31 million people, was “severely impacted,” and the agency lost much of its regional staff, according to an article in Government Executive. “This will have an enormous impact on the program and viability of health centers,” an HRSA employee said. 

About 50% of the nearly 900 SAMHSA employees were laid off and its 10 regional offices were closed. SAMHSA will be “hamstrung for data,” according to an agency employee, who added contracts may be cut en masse due the departure of the contract management staff. They added that even if funding remains for the agency, the support systems for grantees were being decimated.

More than 800 people lost their jobs at the CDER, according to an official who was laid off; this part of the agency had around 6,000 employees before the cuts.

Indian Health Service

The IHS offers a rare bright spot. Although it was also in line for massive cuts, it has been spared, for now. According to a statement emailed to Native News Online, Secretary Kennedy said the Trump administration intends to prioritize the IHS.

“The Indian Health Service has always been treated as the redheaded stepchild at HHS,” Secretary Kennedy wrote. “My father often complained that IHS was chronically understaffed and underfunded. President Trump wants me to rectify this sad history. Indians suffer at the highest level of chronic disease of any demographic. IHS will be a priority over the next 4 years. President Trump wants me to end the chronic disease epidemic beginning in Indian country.”

March layoffs that had been announced for 1000 IHS employees were rescinded.

“We can confirm the layoffs were rescinded thanks at least in part to advocacy by the many Tribal organizations,” a spokesperson for the National Indian Health Board told Native News Online.

In fact, top career executives across the department are now being offered reassignments to the IHS, which employees must accept to keep their jobs. One executive who received the offer told Native News Online that no details on positions or location were provided, and they doubted that everyone who got such a notice would ultimately be matched to a suitable position. 

"Streamline the Agency"

The dramatic actions at HHS were not unexpected. In fact, employees had been in an unsettling limbo since Kennedy was appointed Secretary, not knowing when the axe would fall, or where, or on whom. Kennedy, when describing the restructuring plans, said, “We're going to streamline our agency and eliminate the redundancies and invite everyone to align behind a simple, bold mission. I want every HHS employee to wake up every morning asking themselves, ‘What can I do to restore American Health?’ I want to empower everyone in the HHS family to have a sense of purpose and pride and a sense of personal agency and responsibility to this larger goal.”

“The FDA as we've known it is finished,” Dr. Robert M. Califf, who served as FDA commissioner twice, wrote on LinkedIn. In an interview with CNN, Califf said he was dismayed to see how federal workers were being treated. 

“This is a sad and inhumane way to treat people,” he said. “It’s different when you’re a company and you’re out of money and you can’t pay people, but the federal government can pay people and do things in an orderly, respectful fashion—and not have them end up in line trying to get to work and have their badges not work as a way to fire them.” 

But the fired HHS employees aren’t the only ones who will bear the brunt of the cuts. “Today’s announcement is not just a restructuring of the Department of Health and Human Services. It is a catastrophe for the health care of every American,” Senator Ed Markey (D-MA) said in a press briefing.

Calling the cuts “a recipe for disaster,” former CDC director Tom Frieden said, “[Secretary] Kennedy claims that health care services will not be harmed by the dramatic downsizing, but he is wrong, and everyone who is paying any attention knows it.”

Senators Bill Cassidy (R-LA) and Bernie Sanders (I-VT), of the Senate Health, Education, Labor, and Pensions Committee, announced Tuesday that they were inviting Kennedy to a hearing April 10 about the restructuring of HHS. “This will be a good opportunity,” Cassidy said in a statement, “for him to set the record straight and speak to the goals, structure and benefits of the proposed reorganization.”

On March 27, Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. said he planned to cut about 10,000 full-time jobs from the department in a sweeping “reorganization.” Less than a week later, the reduction in force (RIF) notifications were sent out, and in the very early hours of April 1, hundreds of employees found themselves locked out from their offices, often so abruptly their belongings were left behind. 

Most affected employees were told they would be placed on administrative leave; some were told to continue working until they can hand off their duties but they would be formally separated on June 2. Many of the email RIF notifications used the recommended wording provided by the US Office of Personnel Management: “This RIF action does not reflect directly on your service, performance, or conduct.” The HHS workforce is expected to be reduced from 82,000 full-time employees to 62,000. 

"The Trump Administration has launched an unprecedented attack on the federal health workforce," said House Energy and Commerce Committee Ranking Member Frank Pallone, Jr. (D-NJ), during an oversight and investigations hearing on medical device technology and cybersecurity.

The cuts in personnel and programs are broad and deep, and touch every aspect of public health. Alzheimer’s disease programs are being eliminated, measles vaccine clinics are being shuttered, and tuberculosis, HIV prevention, and cancer research are being stalled. A Reddit thread for RIF notices from HHS employees had nearly 750 postings, suggesting a broad cross-section of individuals and departments had received them. 

Secretary Kennedy stated the layoffs and restructuring will save $1.8 billion a year. “We aren’t just reducing bureaucratic sprawl," he said in a statement. "We are realigning the organization with its core mission and our new priorities in reversing the chronic disease epidemic.” On the social platform X, Kennedy acknowledged, “This will be a painful period for HHS.”

Entire offices devoted to Freedom of Information Act-related requests, communications, and human resources were also shut down, according to multiple reports.

The agency's 28 divisions will be reformatted into a “new, unified entity” of 15 divisions—the Administration for a Healthy America, or AHA, aimed at carrying out Kennedy's “Make America Healthy Again” agenda. The AHA will include the Substance Abuse and Mental Health Services Administration (SAMHSA), the Agency for Toxic Substances and Disease Registry, and the National Institute for Occupational Safety and Health. The Administration for Community Living's functions will shift into the Centers for Medicare and Medicaid Services, the Administration for Children and Families, and the Assistant Secretary for Planning and Evaluation (ASPE). ASPE will be combined with the Agency for Health Research and Quality into the Office of Strategy

 “This centralization,” HHS says, “will improve coordination of health resources for low-income Americans and will focus on areas including, Primary Care, Maternal and Child Health, Mental Health, Environmental Health, HIV/AIDS, and Workforce development.”

US Food and Drug Administration

An estimated 3500 full-time FDA employees are expected to receive RIF notices. The agency said reductions will not affect drug, medical device, or food reviewers or inspectors. 

Politico spoke with fired employees on condition of anonymity. According to them, Dr. Peter Stein, director of the FDA Office of New Drugs (OND), was let go. The policy office inside of OND was also eliminated. Another top FDA regulator, Dr. Brian King, the director of the Center for Tobacco Products (CTP), was placed on administrative leave, according to an email sent to his staff and obtained by Politico. “I encourage you to hold your heads high and never compromise the guiding tenets that CTP has held dear since its inception,” King wrote in the email to his staff. “We obeyed the law. We followed the science. We told the truth.” 

Julie Tierney, who was recently elevated to acting director of the FDA Center for Biologics Evaluation and Research, according to an agency website, was also placed on administrative leave, according to 2 people familiar with the decision. The FDA Office of Strategic Programs, including its director, Sridhar Mantha, has been completely shuttered. Mantha cochaired the Artificial Intelligence (AI) Council at the Center for Drug Evaluation and Research (CDER), which helped develop policy around AI use in drug development and assisted the FDA in using AI internally.

Centers for Disease Control and Prevention

About 2400 CDC employees are expected to receive RIF notices. According to Government Executive, the National Institute for Occupational Safety and Health (NIOSH) sustained more than one-third of the cuts at CDC. About 80% of the 1100 employees at the institute were laid off, including its director and deputy director. An HHS letter to a labor union said about 185 NIOSH employees would be let go in just the Morgantown, W. Va., location. However, NIOSH is apparently slated to be part of the newly created AHA.

Other layoffs hit the National Center for Chronic Disease Prevention and Health Promotion; National Center for Injury Prevention and Control; the National Center for HIV, Viral Hepatitis, STD, and Tuberculosis Prevention; the Global Health Center; the National Center on Birth Defects and Developmental Disabilities; and the National Center for Environmental Health. Two sources familiar with the firings said the Office on Smoking and Health was eliminated. The Administration for Strategic Preparedness and Response, currently part of the US Public Health Service, will move to the CDC. 

A compensation program for employees who developed cancer due to radiation exposure while working for the federal government was also eliminated. Similarly, a national registry that tracks rates of cancer among firefighters was cut. One employee said NIOSH laid off veterinarians despite the bureau having laboratory animals that need care. 

National Institutes of Health 

NIH will lose 1200 employees, due to "centralizing” procurement, human resources, and communications across its 27 institutes and centers. According to the employees who spoke with Politico, scientists were also targeted, including National Institute of Nursing Research Director Shannon Zenk; National Institute of Child Health and Human Development Director Diana Bianchi; Emily Erbelding, who leads the Division of Microbiology and Infectious Diseases at National Institutes of Allergy and Infectious Diseases; and National Institute on Minority Health and Health Disparities Director Eliseo Pérez-Stable. National Institute of Allergy and Infectious Diseases Director Jeanne Marrazzo, who replaced Anthony Fauci, was also put on leave.

In his “welcome” email to staff, the new NIH director, Dr. Jay Bhattacharya, wrote: “I recognize that I am joining NIH at a time of tremendous change. Every inch of the federal government is under scrutiny—and NIH is not exempt. These reductions in the workforce will have a profound impact on key NIH administrative functions, including communications, legislative affairs, procurement, and human resources, and will require an entirely new approach to how we carry them out.”

Deep Cuts at Other HHS Agencies

As many as 500 to 600 people were let go at the Health Resource and Services Administration (HRSA). Its Bureau of Primary Health Care, which oversees the national network of health care centers that collectively provide care to 31 million people, was “severely impacted,” and the agency lost much of its regional staff, according to an article in Government Executive. “This will have an enormous impact on the program and viability of health centers,” an HRSA employee said. 

About 50% of the nearly 900 SAMHSA employees were laid off and its 10 regional offices were closed. SAMHSA will be “hamstrung for data,” according to an agency employee, who added contracts may be cut en masse due the departure of the contract management staff. They added that even if funding remains for the agency, the support systems for grantees were being decimated.

More than 800 people lost their jobs at the CDER, according to an official who was laid off; this part of the agency had around 6,000 employees before the cuts.

Indian Health Service

The IHS offers a rare bright spot. Although it was also in line for massive cuts, it has been spared, for now. According to a statement emailed to Native News Online, Secretary Kennedy said the Trump administration intends to prioritize the IHS.

“The Indian Health Service has always been treated as the redheaded stepchild at HHS,” Secretary Kennedy wrote. “My father often complained that IHS was chronically understaffed and underfunded. President Trump wants me to rectify this sad history. Indians suffer at the highest level of chronic disease of any demographic. IHS will be a priority over the next 4 years. President Trump wants me to end the chronic disease epidemic beginning in Indian country.”

March layoffs that had been announced for 1000 IHS employees were rescinded.

“We can confirm the layoffs were rescinded thanks at least in part to advocacy by the many Tribal organizations,” a spokesperson for the National Indian Health Board told Native News Online.

In fact, top career executives across the department are now being offered reassignments to the IHS, which employees must accept to keep their jobs. One executive who received the offer told Native News Online that no details on positions or location were provided, and they doubted that everyone who got such a notice would ultimately be matched to a suitable position. 

"Streamline the Agency"

The dramatic actions at HHS were not unexpected. In fact, employees had been in an unsettling limbo since Kennedy was appointed Secretary, not knowing when the axe would fall, or where, or on whom. Kennedy, when describing the restructuring plans, said, “We're going to streamline our agency and eliminate the redundancies and invite everyone to align behind a simple, bold mission. I want every HHS employee to wake up every morning asking themselves, ‘What can I do to restore American Health?’ I want to empower everyone in the HHS family to have a sense of purpose and pride and a sense of personal agency and responsibility to this larger goal.”

“The FDA as we've known it is finished,” Dr. Robert M. Califf, who served as FDA commissioner twice, wrote on LinkedIn. In an interview with CNN, Califf said he was dismayed to see how federal workers were being treated. 

“This is a sad and inhumane way to treat people,” he said. “It’s different when you’re a company and you’re out of money and you can’t pay people, but the federal government can pay people and do things in an orderly, respectful fashion—and not have them end up in line trying to get to work and have their badges not work as a way to fire them.” 

But the fired HHS employees aren’t the only ones who will bear the brunt of the cuts. “Today’s announcement is not just a restructuring of the Department of Health and Human Services. It is a catastrophe for the health care of every American,” Senator Ed Markey (D-MA) said in a press briefing.

Calling the cuts “a recipe for disaster,” former CDC director Tom Frieden said, “[Secretary] Kennedy claims that health care services will not be harmed by the dramatic downsizing, but he is wrong, and everyone who is paying any attention knows it.”

Senators Bill Cassidy (R-LA) and Bernie Sanders (I-VT), of the Senate Health, Education, Labor, and Pensions Committee, announced Tuesday that they were inviting Kennedy to a hearing April 10 about the restructuring of HHS. “This will be a good opportunity,” Cassidy said in a statement, “for him to set the record straight and speak to the goals, structure and benefits of the proposed reorganization.”

The United States Food and Drug Administration (FDA) has expanded the approval for lutetium Lu 177 vipivotide tetraxetan (Pluvicto, Novartis) to include adults with prostate-specific membrane antigen (PSMA)–positive metastatic castration-resistant prostate cancer (mCRPC), who have received androgen receptor pathway inhibitor (ARPI) therapy and are considered appropriate to delay taxane-based chemotherapy.

The radioligand therapeutic agent was previously approved for the treatment of PSMA-positive mCRPC in patients who have already received ARPI therapy and taxane-based chemotherapy. Approval for the expanded indication was based on efficacy demonstrated in the randomized, open-label, phase 3 PSMAfore trial.

Treatment in 468 patients who progressed on one ARPI and who were deemed appropriate for delay of taxane-based chemotherapy was associated with improved radiographic progression-free survival (rPFS) and overall survival (OS) vs a different ARPI.

Patients were randomized 1:1 to receive lutetium Lu 177 vipivotide tetraxetan (7.4 GBq [200 mCi] every 6 weeks for six doses) or to receive a different ARPI, according to a statement from the FDA. Those who progressed on the new ARPI were allowed to cross over to the experimental therapy arm after progression, and 60% did so.

Median rPFS was 9.3 vs 5.6 months in the experimental and control arms, respectively (hazard ratio [HR], 0.41). Median OS durations were 24.5 and 23.1 months, respectively (HR, 0.91), but the difference in OS did not reach statistical significance.

Adverse reactions were consistent with the known safety profile of lutetium Lu 177 vipivotide tetraxetan, which includes possible radiation exposure, myelosuppression, and renal toxicity.

The recommended dose, according to prescribing information, is 7.4 GBq (200 mCi) administered intravenously every 6 weeks for six doses or until disease progression or unacceptable toxicity.

“The earlier indication for Pluvicto could really change our treatment paradigms for patients with mCRPC. It offers a targeted therapy that better delays disease progression compared to a second ARPI,” Michael Morris, MD, of Memorial Sloan Kettering Cancer Center, New York, and the principal investigator of the study in the United States stated in a Novartis press release. “This approval is a significant step forward and should open the doorway to a therapy that has clear clinical advantages for the patient with mCRPC who has progressed on one ARPI and has not received chemotherapy.”

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

The United States Food and Drug Administration (FDA) has expanded the approval for lutetium Lu 177 vipivotide tetraxetan (Pluvicto, Novartis) to include adults with prostate-specific membrane antigen (PSMA)–positive metastatic castration-resistant prostate cancer (mCRPC), who have received androgen receptor pathway inhibitor (ARPI) therapy and are considered appropriate to delay taxane-based chemotherapy.

The radioligand therapeutic agent was previously approved for the treatment of PSMA-positive mCRPC in patients who have already received ARPI therapy and taxane-based chemotherapy. Approval for the expanded indication was based on efficacy demonstrated in the randomized, open-label, phase 3 PSMAfore trial.

Treatment in 468 patients who progressed on one ARPI and who were deemed appropriate for delay of taxane-based chemotherapy was associated with improved radiographic progression-free survival (rPFS) and overall survival (OS) vs a different ARPI.

Patients were randomized 1:1 to receive lutetium Lu 177 vipivotide tetraxetan (7.4 GBq [200 mCi] every 6 weeks for six doses) or to receive a different ARPI, according to a statement from the FDA. Those who progressed on the new ARPI were allowed to cross over to the experimental therapy arm after progression, and 60% did so.

Median rPFS was 9.3 vs 5.6 months in the experimental and control arms, respectively (hazard ratio [HR], 0.41). Median OS durations were 24.5 and 23.1 months, respectively (HR, 0.91), but the difference in OS did not reach statistical significance.

Adverse reactions were consistent with the known safety profile of lutetium Lu 177 vipivotide tetraxetan, which includes possible radiation exposure, myelosuppression, and renal toxicity.

The recommended dose, according to prescribing information, is 7.4 GBq (200 mCi) administered intravenously every 6 weeks for six doses or until disease progression or unacceptable toxicity.

“The earlier indication for Pluvicto could really change our treatment paradigms for patients with mCRPC. It offers a targeted therapy that better delays disease progression compared to a second ARPI,” Michael Morris, MD, of Memorial Sloan Kettering Cancer Center, New York, and the principal investigator of the study in the United States stated in a Novartis press release. “This approval is a significant step forward and should open the doorway to a therapy that has clear clinical advantages for the patient with mCRPC who has progressed on one ARPI and has not received chemotherapy.”

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

The United States Food and Drug Administration (FDA) has expanded the approval for lutetium Lu 177 vipivotide tetraxetan (Pluvicto, Novartis) to include adults with prostate-specific membrane antigen (PSMA)–positive metastatic castration-resistant prostate cancer (mCRPC), who have received androgen receptor pathway inhibitor (ARPI) therapy and are considered appropriate to delay taxane-based chemotherapy.

The radioligand therapeutic agent was previously approved for the treatment of PSMA-positive mCRPC in patients who have already received ARPI therapy and taxane-based chemotherapy. Approval for the expanded indication was based on efficacy demonstrated in the randomized, open-label, phase 3 PSMAfore trial.

Treatment in 468 patients who progressed on one ARPI and who were deemed appropriate for delay of taxane-based chemotherapy was associated with improved radiographic progression-free survival (rPFS) and overall survival (OS) vs a different ARPI.

Patients were randomized 1:1 to receive lutetium Lu 177 vipivotide tetraxetan (7.4 GBq [200 mCi] every 6 weeks for six doses) or to receive a different ARPI, according to a statement from the FDA. Those who progressed on the new ARPI were allowed to cross over to the experimental therapy arm after progression, and 60% did so.

Median rPFS was 9.3 vs 5.6 months in the experimental and control arms, respectively (hazard ratio [HR], 0.41). Median OS durations were 24.5 and 23.1 months, respectively (HR, 0.91), but the difference in OS did not reach statistical significance.

Adverse reactions were consistent with the known safety profile of lutetium Lu 177 vipivotide tetraxetan, which includes possible radiation exposure, myelosuppression, and renal toxicity.

The recommended dose, according to prescribing information, is 7.4 GBq (200 mCi) administered intravenously every 6 weeks for six doses or until disease progression or unacceptable toxicity.

“The earlier indication for Pluvicto could really change our treatment paradigms for patients with mCRPC. It offers a targeted therapy that better delays disease progression compared to a second ARPI,” Michael Morris, MD, of Memorial Sloan Kettering Cancer Center, New York, and the principal investigator of the study in the United States stated in a Novartis press release. “This approval is a significant step forward and should open the doorway to a therapy that has clear clinical advantages for the patient with mCRPC who has progressed on one ARPI and has not received chemotherapy.”

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