Ob.Gyn. News

Heartland virus (HRTV), an emerging infection first detected in lone star ticks in Missouri in 2009, has spread to lone star ticks in Georgia, a study published in Emerging Infectious Diseases reports.

HRTV disease is transmitted by the bite of an infected Amblyomma americanum tick, named “lone star” because of the silver-white spot on the female scutum (back).

“By … sampling … in an area with reported exposure to HRTV in wildlife and humans and testing for infection in thousands of ticks from multiple sites and physiologic stages, we confirmed the presence of HRTV in Georgia,” the authors write.

“This information about the expanding geographic range of lone star ticks, combined with increased human presence in tick-infested habitats, can be used to improve strategies for preventing tick bites and to alert physicians about this emerging tickborne virus infection,” a press release by the Centers for Disease Control and Prevention notes.
 

Persistent field and lab work led to HRTV discovery in Georgia

The search for infected lone star ticks began after a retroactive analysis confirmed that a person who died in Georgia in 2005 from an unidentified illness was infected with HRTV. A subsequent analysis of serum samples collected earlier from local white-tailed deer showed that the deer had been exposed to HRTV since at least 2001, according to a press release by Emory University.

These discoveries prompted local researchers to investigate whether lone star ticks in rural, woodsy central Georgia were carrying HRTV.

Lead study author Yamila Romer, MD, an infectious disease clinician and microbiologist in the department of environmental sciences at Emory University in Atlanta, and her colleagues collected samples of ticks in 2018 at 26 sites near the location of the patient who died and the seropositive deer. In 2019, they focused their collections on the two sites that had provided the most ticks in 2018.

From April to October in both years, the research team visited sites weekly to swish white flannel flags through underbrush. They picked off adult and nymph Amblyomma americanum ticks, placed them into vials, and transported them to their lab. They sorted 9,294 ticks by sex, life stage, and collection site. Then they crushed the ticks and extracted their RNA.

To confirm viral infection, the team tested RNA extracted from cell culture supernatants using a real-time polymerase chain reaction test specific for HRTV.

In the three pools of ticks that tested positive for HRTV, the researchers found a minimum infection rate of 0.46/1,000 ticks, suggesting that about 1 of every 2,000 ticks carried HRTV. They sequenced the genome of the three isolates and found that the genomes were similar to one another but were very different from the genomes from HRTV samples taken outside Georgia.

Catherine A. Hill, PhD, a professor of entomology and vector biology and the interim head of the department of entomology at Purdue University in West Lafayette, Ind., was impressed with the researchers’ discovery.

“Heartland virus is difficult to detect,” she said in an email. “The prevalence of human cases is low, and the virus appears to be present at very low levels in populations of lone star tick. The investigators went to some lengths to survey for the virus, collect, and process thousands of ticks – and they found the needle in the haystack.” Dr. Hill was not involved in the study.
 

Georgia data help researchers monitor HRTV spread

HRTV was first identified in 2009 in Missouri in two people hospitalized with fever, muscle pain, diarrhea, and low white blood cell and platelet counts. Researchers traced the infections to lone star ticks, and they found antibodies to the virus in blood samples from deer and other wild mammals.

According to the CDC, U.S. cases of tick-borne diseases more than doubled between 2004 and 2016. As of January 2021, more than 50 human cases of HRTV disease had been reported in 11 Midwestern and Southeastern states: Arkansas, Georgia, Illinois, Indiana, Iowa, Kansas, Kentucky, Missouri, North Carolina, Oklahoma, and Tennessee.
 

Precautions, signs, symptoms, testing, and treatment

“The lone star tick is aggressive and will actively seek out a human host to bite,” Dr. Hill noted.

She recommends that health care providers advise patients to avoid tick habitat, wear protective clothing, apply repellants, know the signs and symptoms of tick-borne disease, and seek immediate medical care if they become ill.

Common symptoms of HRTV disease include fatigue, fever, nausea, diarrhea, and anorexia. Treatment is supportive. Many patients have been hospitalized, and some with comorbidities have died.

HRTV infection is rarely tested for, and the disease burden is unknown. With no commercial tests available in the United States, the CDC performs molecular and serologic testing for HRTV infection. The agency advises doctors to contact their state health department if they suspect a patient may have HRTV disease.
 

Further research is needed

Samantha M. Wisely, PhD, a professor of wildlife ecology and the director of the Cervidae Health Research Initiative at the University of Florida in Gainesville, was not surprised by the study finding.

“The more we look for heartland virus, the more places we find it,” Dr. Wisely told this news organization in an email.

“Little is known about which wildlife play a role in maintaining the virus on the landscape,” said Dr. Wisely, who was not involved in the study. “White-tailed deer have been shown to produce antibodies, meaning they have been exposed to the virus, but no one has actually found the virus in a wildlife species.”

The whole-genome sequencing of the virus was particularly important, Dr. Wisely explained. “Whole-genome data allow researchers to better understand viral evolution, pathogenicity, and viral dynamics across space and time – how it is evolving.”

The study was supported by a grant from the Emory University Research Council. The authors, Dr. Wisely, and Dr. Hill have disclosed no relevant financial relationships.

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

Heartland virus (HRTV), an emerging infection first detected in lone star ticks in Missouri in 2009, has spread to lone star ticks in Georgia, a study published in Emerging Infectious Diseases reports.

HRTV disease is transmitted by the bite of an infected Amblyomma americanum tick, named “lone star” because of the silver-white spot on the female scutum (back).

“By … sampling … in an area with reported exposure to HRTV in wildlife and humans and testing for infection in thousands of ticks from multiple sites and physiologic stages, we confirmed the presence of HRTV in Georgia,” the authors write.

“This information about the expanding geographic range of lone star ticks, combined with increased human presence in tick-infested habitats, can be used to improve strategies for preventing tick bites and to alert physicians about this emerging tickborne virus infection,” a press release by the Centers for Disease Control and Prevention notes.
 

Persistent field and lab work led to HRTV discovery in Georgia

The search for infected lone star ticks began after a retroactive analysis confirmed that a person who died in Georgia in 2005 from an unidentified illness was infected with HRTV. A subsequent analysis of serum samples collected earlier from local white-tailed deer showed that the deer had been exposed to HRTV since at least 2001, according to a press release by Emory University.

These discoveries prompted local researchers to investigate whether lone star ticks in rural, woodsy central Georgia were carrying HRTV.

Lead study author Yamila Romer, MD, an infectious disease clinician and microbiologist in the department of environmental sciences at Emory University in Atlanta, and her colleagues collected samples of ticks in 2018 at 26 sites near the location of the patient who died and the seropositive deer. In 2019, they focused their collections on the two sites that had provided the most ticks in 2018.

From April to October in both years, the research team visited sites weekly to swish white flannel flags through underbrush. They picked off adult and nymph Amblyomma americanum ticks, placed them into vials, and transported them to their lab. They sorted 9,294 ticks by sex, life stage, and collection site. Then they crushed the ticks and extracted their RNA.

To confirm viral infection, the team tested RNA extracted from cell culture supernatants using a real-time polymerase chain reaction test specific for HRTV.

In the three pools of ticks that tested positive for HRTV, the researchers found a minimum infection rate of 0.46/1,000 ticks, suggesting that about 1 of every 2,000 ticks carried HRTV. They sequenced the genome of the three isolates and found that the genomes were similar to one another but were very different from the genomes from HRTV samples taken outside Georgia.

Catherine A. Hill, PhD, a professor of entomology and vector biology and the interim head of the department of entomology at Purdue University in West Lafayette, Ind., was impressed with the researchers’ discovery.

“Heartland virus is difficult to detect,” she said in an email. “The prevalence of human cases is low, and the virus appears to be present at very low levels in populations of lone star tick. The investigators went to some lengths to survey for the virus, collect, and process thousands of ticks – and they found the needle in the haystack.” Dr. Hill was not involved in the study.
 

Georgia data help researchers monitor HRTV spread

HRTV was first identified in 2009 in Missouri in two people hospitalized with fever, muscle pain, diarrhea, and low white blood cell and platelet counts. Researchers traced the infections to lone star ticks, and they found antibodies to the virus in blood samples from deer and other wild mammals.

According to the CDC, U.S. cases of tick-borne diseases more than doubled between 2004 and 2016. As of January 2021, more than 50 human cases of HRTV disease had been reported in 11 Midwestern and Southeastern states: Arkansas, Georgia, Illinois, Indiana, Iowa, Kansas, Kentucky, Missouri, North Carolina, Oklahoma, and Tennessee.
 

Precautions, signs, symptoms, testing, and treatment

“The lone star tick is aggressive and will actively seek out a human host to bite,” Dr. Hill noted.

She recommends that health care providers advise patients to avoid tick habitat, wear protective clothing, apply repellants, know the signs and symptoms of tick-borne disease, and seek immediate medical care if they become ill.

Common symptoms of HRTV disease include fatigue, fever, nausea, diarrhea, and anorexia. Treatment is supportive. Many patients have been hospitalized, and some with comorbidities have died.

HRTV infection is rarely tested for, and the disease burden is unknown. With no commercial tests available in the United States, the CDC performs molecular and serologic testing for HRTV infection. The agency advises doctors to contact their state health department if they suspect a patient may have HRTV disease.
 

Further research is needed

Samantha M. Wisely, PhD, a professor of wildlife ecology and the director of the Cervidae Health Research Initiative at the University of Florida in Gainesville, was not surprised by the study finding.

“The more we look for heartland virus, the more places we find it,” Dr. Wisely told this news organization in an email.

“Little is known about which wildlife play a role in maintaining the virus on the landscape,” said Dr. Wisely, who was not involved in the study. “White-tailed deer have been shown to produce antibodies, meaning they have been exposed to the virus, but no one has actually found the virus in a wildlife species.”

The whole-genome sequencing of the virus was particularly important, Dr. Wisely explained. “Whole-genome data allow researchers to better understand viral evolution, pathogenicity, and viral dynamics across space and time – how it is evolving.”

The study was supported by a grant from the Emory University Research Council. The authors, Dr. Wisely, and Dr. Hill have disclosed no relevant financial relationships.

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

Heartland virus (HRTV), an emerging infection first detected in lone star ticks in Missouri in 2009, has spread to lone star ticks in Georgia, a study published in Emerging Infectious Diseases reports.

HRTV disease is transmitted by the bite of an infected Amblyomma americanum tick, named “lone star” because of the silver-white spot on the female scutum (back).

“By … sampling … in an area with reported exposure to HRTV in wildlife and humans and testing for infection in thousands of ticks from multiple sites and physiologic stages, we confirmed the presence of HRTV in Georgia,” the authors write.

“This information about the expanding geographic range of lone star ticks, combined with increased human presence in tick-infested habitats, can be used to improve strategies for preventing tick bites and to alert physicians about this emerging tickborne virus infection,” a press release by the Centers for Disease Control and Prevention notes.
 

Persistent field and lab work led to HRTV discovery in Georgia

The search for infected lone star ticks began after a retroactive analysis confirmed that a person who died in Georgia in 2005 from an unidentified illness was infected with HRTV. A subsequent analysis of serum samples collected earlier from local white-tailed deer showed that the deer had been exposed to HRTV since at least 2001, according to a press release by Emory University.

These discoveries prompted local researchers to investigate whether lone star ticks in rural, woodsy central Georgia were carrying HRTV.

Lead study author Yamila Romer, MD, an infectious disease clinician and microbiologist in the department of environmental sciences at Emory University in Atlanta, and her colleagues collected samples of ticks in 2018 at 26 sites near the location of the patient who died and the seropositive deer. In 2019, they focused their collections on the two sites that had provided the most ticks in 2018.

From April to October in both years, the research team visited sites weekly to swish white flannel flags through underbrush. They picked off adult and nymph Amblyomma americanum ticks, placed them into vials, and transported them to their lab. They sorted 9,294 ticks by sex, life stage, and collection site. Then they crushed the ticks and extracted their RNA.

To confirm viral infection, the team tested RNA extracted from cell culture supernatants using a real-time polymerase chain reaction test specific for HRTV.

In the three pools of ticks that tested positive for HRTV, the researchers found a minimum infection rate of 0.46/1,000 ticks, suggesting that about 1 of every 2,000 ticks carried HRTV. They sequenced the genome of the three isolates and found that the genomes were similar to one another but were very different from the genomes from HRTV samples taken outside Georgia.

Catherine A. Hill, PhD, a professor of entomology and vector biology and the interim head of the department of entomology at Purdue University in West Lafayette, Ind., was impressed with the researchers’ discovery.

“Heartland virus is difficult to detect,” she said in an email. “The prevalence of human cases is low, and the virus appears to be present at very low levels in populations of lone star tick. The investigators went to some lengths to survey for the virus, collect, and process thousands of ticks – and they found the needle in the haystack.” Dr. Hill was not involved in the study.
 

Georgia data help researchers monitor HRTV spread

HRTV was first identified in 2009 in Missouri in two people hospitalized with fever, muscle pain, diarrhea, and low white blood cell and platelet counts. Researchers traced the infections to lone star ticks, and they found antibodies to the virus in blood samples from deer and other wild mammals.

According to the CDC, U.S. cases of tick-borne diseases more than doubled between 2004 and 2016. As of January 2021, more than 50 human cases of HRTV disease had been reported in 11 Midwestern and Southeastern states: Arkansas, Georgia, Illinois, Indiana, Iowa, Kansas, Kentucky, Missouri, North Carolina, Oklahoma, and Tennessee.
 

Precautions, signs, symptoms, testing, and treatment

“The lone star tick is aggressive and will actively seek out a human host to bite,” Dr. Hill noted.

She recommends that health care providers advise patients to avoid tick habitat, wear protective clothing, apply repellants, know the signs and symptoms of tick-borne disease, and seek immediate medical care if they become ill.

Common symptoms of HRTV disease include fatigue, fever, nausea, diarrhea, and anorexia. Treatment is supportive. Many patients have been hospitalized, and some with comorbidities have died.

HRTV infection is rarely tested for, and the disease burden is unknown. With no commercial tests available in the United States, the CDC performs molecular and serologic testing for HRTV infection. The agency advises doctors to contact their state health department if they suspect a patient may have HRTV disease.
 

Further research is needed

Samantha M. Wisely, PhD, a professor of wildlife ecology and the director of the Cervidae Health Research Initiative at the University of Florida in Gainesville, was not surprised by the study finding.

“The more we look for heartland virus, the more places we find it,” Dr. Wisely told this news organization in an email.

“Little is known about which wildlife play a role in maintaining the virus on the landscape,” said Dr. Wisely, who was not involved in the study. “White-tailed deer have been shown to produce antibodies, meaning they have been exposed to the virus, but no one has actually found the virus in a wildlife species.”

The whole-genome sequencing of the virus was particularly important, Dr. Wisely explained. “Whole-genome data allow researchers to better understand viral evolution, pathogenicity, and viral dynamics across space and time – how it is evolving.”

The study was supported by a grant from the Emory University Research Council. The authors, Dr. Wisely, and Dr. Hill have disclosed no relevant financial relationships.

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

A cell phone rings in a red-brick bungalow in a village in India. A woman on the other end of the phone tells Ms. SK, a community health worker, that menstruation has started. Ms. SK guns her scooter through the dusty streets for 15 minutes in 30° C (86° F) heat.

A 32-year-old woman, waiting in the shade of a blue corrugated-iron roof, hands over a green polythene bag. Ms. SK whisks the package to the local health center and tucks it into a –20° C freezer. The following week, it will ride in dry ice to the National Institute for Research in Reproductive and Child Health Laboratory in Mumbai for human papillomavirus (HPV) testing.

The two women are participants in the world’s first community-based validation trial of cervical screening using menstrual pads.

This moment in rural India at first glance appears to have little relevance to wealthy countries such as the United States.

However, public health officials in both countries are trying to solve the same problem: how to prevent unnecessary deaths from cervical cancer by reaching women who have never or rarely been screened.

The United States has more in common with India than it may care to admit.

“In the U.S., we still have pockets of disparities that actually have incidence rates [of cervical cancer] comparable to many low- and middle-income countries,” said Vikrant Sahasrabuddhe, MBBS, DrPh, MPH, of the National Cancer Institute, where he heads the HPV and cervical cancer prevention clinical research program for the National Institutes of Health.

The incidence of cervical cancer in India is approximately 19 per 100,000 women. For the past 15 years incidence in the United States has stalled at approximately 7 per 100,000.

In India, there are no organized screening programs and most cervical cancer is regional or distant metastatic at diagnosis.

In the United States, 52% of new cases are advanced, and half of these are among women who have never or rarely been screened.

“There is a critical need for new strategies to reach this population,” Dr. Sahasrabuddhe said. “We absolutely have to do something out of the box creatively.”

Almost all cervical cancers are triggered by HPV, most commonly high-risk HPV-16 and HPV-18, although there are more than 200 types. HPV testing is taking over from cytology (Papanicolaou test) for secondary prevention of cervical cancer.

The trial of screening for HPV in menstrual pads that is ongoing in India was the brainchild of Atul Budukh, PhD, a government public health researcher and professor at the Centre for Cancer Epidemiology, Tata Memorial Centre, Mumbai.

Dr. Budukh’s eyes were opened to the scale of the problem when he participated in a cluster-randomized trial funded by the Bill and Melinda Gates Foundation. The study, published in 2009 in the New England Journal of Medicine, involved 131,746 rural women in the Osmanabad district of India.

A team of researchers from India and France compared outcomes for women over 8 years after cervical screening by HPV, cytology, or visual inspection with acetic acid. The control group was usual care, where women were advised how to seek screening at local hospitals. Women who screened positive were referred for colposcopy, biopsy, and treatment.

Over the 8-year follow-up, advanced cervical cancer was found in twice as many women left to their own devices, compared with women who had HPV testing during the study (82 vs. 39; hazard ratio for HPV, 0.47; 95% confidence interval, 0.32-0.69).

Similarly, cervical cancer deaths in the control group were nearly two times higher than among the women who were screened for HPV in the study (64 vs. 34; HR for HPV, 0.52; 95% CI, 0.33-0.83).

The study proved that rural Indian women were dying unnecessarily because they weren’t seeking cervical screening. And education wasn’t the problem.

“When we go and educate [a rural woman] about ... risk factors and the need to undergo screening, she understands it very well,” said Dr. Budukh. “She is ready to come but her priority is her bread and butter – she will lose her daily wages.”

Dr. Budukh and his team negotiated with local employers so that women could come to screening clinics, but they soon realized this wasn’t scalable.

One year after the NEJM publication, Dr. Budukh found what he was looking for.

A team of Hong Kong clinicians, headed by Sze Chuen Cesar Wong of the Hong Kong Cancer Institute, published a paper in 2010 in the Journal of Clinical Microbiology showing that menstrual pads provide reliable HPV results in women with and without cervical disease.

The Hong Kong team tested sanitary napkins for HPV from 235 of their patients with cervical intraepithelial neoplasia or condyloma acuminatum before and after treatment. Samples were compared with those from 323 women without cervical disease; for HPV in sanitary napkins the sensitivity was 82.8%, specificity was 93.1%, and positive and negative predictive values were 90% and 87.9%, respectively.

The authors pointed out that menstrual pad testing was the only truly noninvasive approach to HPV screening versus the other self-sampling methods such as tampons and cytobrushes. Also, these self-sampling tests require specialized liquid-based transport media. A menstrual pad needs only a plastic bag.

Dr. Budukh had his at-home solution for the hard-working rural women of India.

With funding from the Indian government, Dr. Budukh’s team put together a validation trial that ran from 2013 to 2016 in 18 rural villages in two separate districts: Ahmednagar and Pune.

Local health workers went house to house to recruit women and get family buy-in for this culturally delicate project. Participants were instructed to use their regular sanitary protection – most commonly a washable cloth – and told to call the health worker on the first day of menstruation. Health workers gave each woman a Ziploc bag for the pad and, for privacy, an outer polythene sac.

In Ahmednagar, all women who provided their pad also got screened with Hybrid Capture 2 (HC2; Qiagen) by a mobile screening unit. In Pune, only the positive cases underwent HC2. Screening was also extended to anyone who requested it, but these people were not included in the final analysis.

Genomic DNA was extracted from three 5 mm–sized punches in the pad using a commercial kit, QIAamp DNA Micro, and the quality and purity of the DNA checked by Implen NanoPhotometer.

The team followed the same protocol for PCR HPV assay as the team from Hong Kong.

The results were published in the European Journal of Cancer Prevention in 2018.

The concordance rate for a positive result between the menstrual pad sample and conventional HPV sampling was 98.8% for Ahmednagar and 95.2% for samples from Pune. The sensitivity for the first study was 83% and the specificity 99% – similar to that for the women in Hong Kong. The second study had lower sensitivity and specificity (67% and 88%), partly because of poor storage as a result of frequent power cuts.

The total cost per woman was $30.78.

“I was very excited when we saw the results,” Dr. Budukh recalled. “That day I couldn’t sleep ... such a wonderful result! I was excited to start the next phase immediately.”

Dr. Budukh has applied to the Indian government for funding for a larger trial involving 3,000 women. If successful, he hopes such evidence would be sufficient to convince the Indian government to make menstrual pad screening standard procedure for the 390 million women who live in India’s countryside.

Testing never-screened women for cervical cancer using menstrual pads appears to be relatively reliable, convenient, private, noninvasive, and incredibly cheap.

So who else has tried it?

The first published account of HPV in menstrual blood was a 2003 study by Tommy Tong and colleagues at the Princess Margaret Hospital in Hong Kong. The authors heralded, with lamentable optimism, “a new paradigm in cervical cancer screening.”

In the following 20 years, just six more studies appeared: two from Dr. Budukh’s field trial in India and four from hospital-based pilot studies in Hong Kong (in 2010 and 2018), South Korea (in 2016), and mainland China (in 2021). All these studies, although small, were published in top-flight journals and demonstrate high concordance between conventional high-risk HPV testing and menstrual-blood tests.

This news organization tried to find a U.S. thought-leader who had heard of the approach.

Elizabeth Fontham, MPH, DrPh, is the founding dean of the school of public health at Louisiana State University Health Center in New Orleans, and president of the American Cancer Society. Dr. Fontham said in an email that she had “no plans to evaluate the impact related to menstrual pads, but perhaps others have looked into that.”

Joy Melnikow, MD, MPH, was first author on the evidence synthesis driving the current cervical cancer screening recommendations from the U.S. Preventive Services Task Force. When asked about menstrual pad testing for HPV, she said she had “not heard of it before.”

The USPSTF guidelines don’t mention sanitary pads but acknowledge that “self-collection may be one strategy for increasing screening rates among populations where they are currently low.”

The USPSTF methodology excludes data from countries that don’t match the United States on the Human Development Index “or [are] not applicable to U.S. clinical settings or populations.” (Presumably, data from Hong Kong and South Korea would qualify; Indian data would not.)

Dr. Sahasrabuddhe of the NCI hadn’t heard of menstrual pad testing either, but he has a different explanation for lack of interest in this approach – or, indeed, any form of self-sampling for cervical cancer screening – in the United States.

“We have not seen movement happen in this space for years. ... If there is one intervention that we can simplify, that still has not been made widely available, it is self-sampling ... [but] we don’t have [Food and Drug Administration] approval for it,” Dr. Sahasrabuddhe said.

“Our system, at least in the U.S., is based on industry manufacturers seeking an approval for a particular way of collection and then clinicians and clinical-guideline bodies signing on. ... For a lot of reasons industry has shied away over the past several years, so far, at least, on seeking approval for self-sampling-based approaches,” he commented.

Dr. Sahasrabuddhe aims to change that. He heads a new NCI-led initiative called “The Last Mile,” a nationwide clinical trial supported by federal agencies, industry partners, and professional societies. The goal is to validate self-sampled HPV testing as non-inferior to specimens collected by providers. The team is currently finalizing the methodology of the study, so Dr. Sahasrabuddhe could not share the self-sampling methods that will be on trial, nor the industry partners who have signed up.

The following tests are approved in the United States for physician-collected HPV screening: Hybrid Capture 2, used in the Indian studies (Qiagen); cobas HPV (Roche); Aptima (Hologic); Cervista (Hologic); and Onclarity (Becton Dickinson).

Dr. Sahasrabuddhe said that, while a sanitary pad in a Ziploc bag is unlikely to make the grade for The Last Mile study, he doesn’t totally dismiss their potential and said the NCI is always open to new ideas.

“We are not supporting anybody specifically for menstrual pad-based collection device development,” Dr. Sahasrabuddhe said, “But if they fulfill other criteria for a small business–based grant application, they absolutely are welcome to apply for NCI funding for this.”

Said Dr. Melnikow: “Pre-COVID, the head of [the World Health Organization] said that we could eliminate cervical cancer from the globe and that we have the tools to do that now. And he’s right.”

Dr. Budukh, Dr. Melnikow, and Dr. Sahasrabuddhe disclosed no relevant financial relationships.

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

A cell phone rings in a red-brick bungalow in a village in India. A woman on the other end of the phone tells Ms. SK, a community health worker, that menstruation has started. Ms. SK guns her scooter through the dusty streets for 15 minutes in 30° C (86° F) heat.

A 32-year-old woman, waiting in the shade of a blue corrugated-iron roof, hands over a green polythene bag. Ms. SK whisks the package to the local health center and tucks it into a –20° C freezer. The following week, it will ride in dry ice to the National Institute for Research in Reproductive and Child Health Laboratory in Mumbai for human papillomavirus (HPV) testing.

The two women are participants in the world’s first community-based validation trial of cervical screening using menstrual pads.

This moment in rural India at first glance appears to have little relevance to wealthy countries such as the United States.

However, public health officials in both countries are trying to solve the same problem: how to prevent unnecessary deaths from cervical cancer by reaching women who have never or rarely been screened.

The United States has more in common with India than it may care to admit.

“In the U.S., we still have pockets of disparities that actually have incidence rates [of cervical cancer] comparable to many low- and middle-income countries,” said Vikrant Sahasrabuddhe, MBBS, DrPh, MPH, of the National Cancer Institute, where he heads the HPV and cervical cancer prevention clinical research program for the National Institutes of Health.

The incidence of cervical cancer in India is approximately 19 per 100,000 women. For the past 15 years incidence in the United States has stalled at approximately 7 per 100,000.

In India, there are no organized screening programs and most cervical cancer is regional or distant metastatic at diagnosis.

In the United States, 52% of new cases are advanced, and half of these are among women who have never or rarely been screened.

“There is a critical need for new strategies to reach this population,” Dr. Sahasrabuddhe said. “We absolutely have to do something out of the box creatively.”

Almost all cervical cancers are triggered by HPV, most commonly high-risk HPV-16 and HPV-18, although there are more than 200 types. HPV testing is taking over from cytology (Papanicolaou test) for secondary prevention of cervical cancer.

The trial of screening for HPV in menstrual pads that is ongoing in India was the brainchild of Atul Budukh, PhD, a government public health researcher and professor at the Centre for Cancer Epidemiology, Tata Memorial Centre, Mumbai.

Dr. Budukh’s eyes were opened to the scale of the problem when he participated in a cluster-randomized trial funded by the Bill and Melinda Gates Foundation. The study, published in 2009 in the New England Journal of Medicine, involved 131,746 rural women in the Osmanabad district of India.

A team of researchers from India and France compared outcomes for women over 8 years after cervical screening by HPV, cytology, or visual inspection with acetic acid. The control group was usual care, where women were advised how to seek screening at local hospitals. Women who screened positive were referred for colposcopy, biopsy, and treatment.

Over the 8-year follow-up, advanced cervical cancer was found in twice as many women left to their own devices, compared with women who had HPV testing during the study (82 vs. 39; hazard ratio for HPV, 0.47; 95% confidence interval, 0.32-0.69).

Similarly, cervical cancer deaths in the control group were nearly two times higher than among the women who were screened for HPV in the study (64 vs. 34; HR for HPV, 0.52; 95% CI, 0.33-0.83).

The study proved that rural Indian women were dying unnecessarily because they weren’t seeking cervical screening. And education wasn’t the problem.

“When we go and educate [a rural woman] about ... risk factors and the need to undergo screening, she understands it very well,” said Dr. Budukh. “She is ready to come but her priority is her bread and butter – she will lose her daily wages.”

Dr. Budukh and his team negotiated with local employers so that women could come to screening clinics, but they soon realized this wasn’t scalable.

One year after the NEJM publication, Dr. Budukh found what he was looking for.

A team of Hong Kong clinicians, headed by Sze Chuen Cesar Wong of the Hong Kong Cancer Institute, published a paper in 2010 in the Journal of Clinical Microbiology showing that menstrual pads provide reliable HPV results in women with and without cervical disease.

The Hong Kong team tested sanitary napkins for HPV from 235 of their patients with cervical intraepithelial neoplasia or condyloma acuminatum before and after treatment. Samples were compared with those from 323 women without cervical disease; for HPV in sanitary napkins the sensitivity was 82.8%, specificity was 93.1%, and positive and negative predictive values were 90% and 87.9%, respectively.

The authors pointed out that menstrual pad testing was the only truly noninvasive approach to HPV screening versus the other self-sampling methods such as tampons and cytobrushes. Also, these self-sampling tests require specialized liquid-based transport media. A menstrual pad needs only a plastic bag.

Dr. Budukh had his at-home solution for the hard-working rural women of India.

With funding from the Indian government, Dr. Budukh’s team put together a validation trial that ran from 2013 to 2016 in 18 rural villages in two separate districts: Ahmednagar and Pune.

Local health workers went house to house to recruit women and get family buy-in for this culturally delicate project. Participants were instructed to use their regular sanitary protection – most commonly a washable cloth – and told to call the health worker on the first day of menstruation. Health workers gave each woman a Ziploc bag for the pad and, for privacy, an outer polythene sac.

In Ahmednagar, all women who provided their pad also got screened with Hybrid Capture 2 (HC2; Qiagen) by a mobile screening unit. In Pune, only the positive cases underwent HC2. Screening was also extended to anyone who requested it, but these people were not included in the final analysis.

Genomic DNA was extracted from three 5 mm–sized punches in the pad using a commercial kit, QIAamp DNA Micro, and the quality and purity of the DNA checked by Implen NanoPhotometer.

The team followed the same protocol for PCR HPV assay as the team from Hong Kong.

The results were published in the European Journal of Cancer Prevention in 2018.

The concordance rate for a positive result between the menstrual pad sample and conventional HPV sampling was 98.8% for Ahmednagar and 95.2% for samples from Pune. The sensitivity for the first study was 83% and the specificity 99% – similar to that for the women in Hong Kong. The second study had lower sensitivity and specificity (67% and 88%), partly because of poor storage as a result of frequent power cuts.

The total cost per woman was $30.78.

“I was very excited when we saw the results,” Dr. Budukh recalled. “That day I couldn’t sleep ... such a wonderful result! I was excited to start the next phase immediately.”

Dr. Budukh has applied to the Indian government for funding for a larger trial involving 3,000 women. If successful, he hopes such evidence would be sufficient to convince the Indian government to make menstrual pad screening standard procedure for the 390 million women who live in India’s countryside.

Testing never-screened women for cervical cancer using menstrual pads appears to be relatively reliable, convenient, private, noninvasive, and incredibly cheap.

So who else has tried it?

The first published account of HPV in menstrual blood was a 2003 study by Tommy Tong and colleagues at the Princess Margaret Hospital in Hong Kong. The authors heralded, with lamentable optimism, “a new paradigm in cervical cancer screening.”

In the following 20 years, just six more studies appeared: two from Dr. Budukh’s field trial in India and four from hospital-based pilot studies in Hong Kong (in 2010 and 2018), South Korea (in 2016), and mainland China (in 2021). All these studies, although small, were published in top-flight journals and demonstrate high concordance between conventional high-risk HPV testing and menstrual-blood tests.

This news organization tried to find a U.S. thought-leader who had heard of the approach.

Elizabeth Fontham, MPH, DrPh, is the founding dean of the school of public health at Louisiana State University Health Center in New Orleans, and president of the American Cancer Society. Dr. Fontham said in an email that she had “no plans to evaluate the impact related to menstrual pads, but perhaps others have looked into that.”

Joy Melnikow, MD, MPH, was first author on the evidence synthesis driving the current cervical cancer screening recommendations from the U.S. Preventive Services Task Force. When asked about menstrual pad testing for HPV, she said she had “not heard of it before.”

The USPSTF guidelines don’t mention sanitary pads but acknowledge that “self-collection may be one strategy for increasing screening rates among populations where they are currently low.”

The USPSTF methodology excludes data from countries that don’t match the United States on the Human Development Index “or [are] not applicable to U.S. clinical settings or populations.” (Presumably, data from Hong Kong and South Korea would qualify; Indian data would not.)

Dr. Sahasrabuddhe of the NCI hadn’t heard of menstrual pad testing either, but he has a different explanation for lack of interest in this approach – or, indeed, any form of self-sampling for cervical cancer screening – in the United States.

“We have not seen movement happen in this space for years. ... If there is one intervention that we can simplify, that still has not been made widely available, it is self-sampling ... [but] we don’t have [Food and Drug Administration] approval for it,” Dr. Sahasrabuddhe said.

“Our system, at least in the U.S., is based on industry manufacturers seeking an approval for a particular way of collection and then clinicians and clinical-guideline bodies signing on. ... For a lot of reasons industry has shied away over the past several years, so far, at least, on seeking approval for self-sampling-based approaches,” he commented.

Dr. Sahasrabuddhe aims to change that. He heads a new NCI-led initiative called “The Last Mile,” a nationwide clinical trial supported by federal agencies, industry partners, and professional societies. The goal is to validate self-sampled HPV testing as non-inferior to specimens collected by providers. The team is currently finalizing the methodology of the study, so Dr. Sahasrabuddhe could not share the self-sampling methods that will be on trial, nor the industry partners who have signed up.

The following tests are approved in the United States for physician-collected HPV screening: Hybrid Capture 2, used in the Indian studies (Qiagen); cobas HPV (Roche); Aptima (Hologic); Cervista (Hologic); and Onclarity (Becton Dickinson).

Dr. Sahasrabuddhe said that, while a sanitary pad in a Ziploc bag is unlikely to make the grade for The Last Mile study, he doesn’t totally dismiss their potential and said the NCI is always open to new ideas.

“We are not supporting anybody specifically for menstrual pad-based collection device development,” Dr. Sahasrabuddhe said, “But if they fulfill other criteria for a small business–based grant application, they absolutely are welcome to apply for NCI funding for this.”

Said Dr. Melnikow: “Pre-COVID, the head of [the World Health Organization] said that we could eliminate cervical cancer from the globe and that we have the tools to do that now. And he’s right.”

Dr. Budukh, Dr. Melnikow, and Dr. Sahasrabuddhe disclosed no relevant financial relationships.

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

A cell phone rings in a red-brick bungalow in a village in India. A woman on the other end of the phone tells Ms. SK, a community health worker, that menstruation has started. Ms. SK guns her scooter through the dusty streets for 15 minutes in 30° C (86° F) heat.

A 32-year-old woman, waiting in the shade of a blue corrugated-iron roof, hands over a green polythene bag. Ms. SK whisks the package to the local health center and tucks it into a –20° C freezer. The following week, it will ride in dry ice to the National Institute for Research in Reproductive and Child Health Laboratory in Mumbai for human papillomavirus (HPV) testing.

The two women are participants in the world’s first community-based validation trial of cervical screening using menstrual pads.

This moment in rural India at first glance appears to have little relevance to wealthy countries such as the United States.

However, public health officials in both countries are trying to solve the same problem: how to prevent unnecessary deaths from cervical cancer by reaching women who have never or rarely been screened.

The United States has more in common with India than it may care to admit.

“In the U.S., we still have pockets of disparities that actually have incidence rates [of cervical cancer] comparable to many low- and middle-income countries,” said Vikrant Sahasrabuddhe, MBBS, DrPh, MPH, of the National Cancer Institute, where he heads the HPV and cervical cancer prevention clinical research program for the National Institutes of Health.

The incidence of cervical cancer in India is approximately 19 per 100,000 women. For the past 15 years incidence in the United States has stalled at approximately 7 per 100,000.

In India, there are no organized screening programs and most cervical cancer is regional or distant metastatic at diagnosis.

In the United States, 52% of new cases are advanced, and half of these are among women who have never or rarely been screened.

“There is a critical need for new strategies to reach this population,” Dr. Sahasrabuddhe said. “We absolutely have to do something out of the box creatively.”

Almost all cervical cancers are triggered by HPV, most commonly high-risk HPV-16 and HPV-18, although there are more than 200 types. HPV testing is taking over from cytology (Papanicolaou test) for secondary prevention of cervical cancer.

The trial of screening for HPV in menstrual pads that is ongoing in India was the brainchild of Atul Budukh, PhD, a government public health researcher and professor at the Centre for Cancer Epidemiology, Tata Memorial Centre, Mumbai.

Dr. Budukh’s eyes were opened to the scale of the problem when he participated in a cluster-randomized trial funded by the Bill and Melinda Gates Foundation. The study, published in 2009 in the New England Journal of Medicine, involved 131,746 rural women in the Osmanabad district of India.

A team of researchers from India and France compared outcomes for women over 8 years after cervical screening by HPV, cytology, or visual inspection with acetic acid. The control group was usual care, where women were advised how to seek screening at local hospitals. Women who screened positive were referred for colposcopy, biopsy, and treatment.

Over the 8-year follow-up, advanced cervical cancer was found in twice as many women left to their own devices, compared with women who had HPV testing during the study (82 vs. 39; hazard ratio for HPV, 0.47; 95% confidence interval, 0.32-0.69).

Similarly, cervical cancer deaths in the control group were nearly two times higher than among the women who were screened for HPV in the study (64 vs. 34; HR for HPV, 0.52; 95% CI, 0.33-0.83).

The study proved that rural Indian women were dying unnecessarily because they weren’t seeking cervical screening. And education wasn’t the problem.

“When we go and educate [a rural woman] about ... risk factors and the need to undergo screening, she understands it very well,” said Dr. Budukh. “She is ready to come but her priority is her bread and butter – she will lose her daily wages.”

Dr. Budukh and his team negotiated with local employers so that women could come to screening clinics, but they soon realized this wasn’t scalable.

One year after the NEJM publication, Dr. Budukh found what he was looking for.

A team of Hong Kong clinicians, headed by Sze Chuen Cesar Wong of the Hong Kong Cancer Institute, published a paper in 2010 in the Journal of Clinical Microbiology showing that menstrual pads provide reliable HPV results in women with and without cervical disease.

The Hong Kong team tested sanitary napkins for HPV from 235 of their patients with cervical intraepithelial neoplasia or condyloma acuminatum before and after treatment. Samples were compared with those from 323 women without cervical disease; for HPV in sanitary napkins the sensitivity was 82.8%, specificity was 93.1%, and positive and negative predictive values were 90% and 87.9%, respectively.

The authors pointed out that menstrual pad testing was the only truly noninvasive approach to HPV screening versus the other self-sampling methods such as tampons and cytobrushes. Also, these self-sampling tests require specialized liquid-based transport media. A menstrual pad needs only a plastic bag.

Dr. Budukh had his at-home solution for the hard-working rural women of India.

With funding from the Indian government, Dr. Budukh’s team put together a validation trial that ran from 2013 to 2016 in 18 rural villages in two separate districts: Ahmednagar and Pune.

Local health workers went house to house to recruit women and get family buy-in for this culturally delicate project. Participants were instructed to use their regular sanitary protection – most commonly a washable cloth – and told to call the health worker on the first day of menstruation. Health workers gave each woman a Ziploc bag for the pad and, for privacy, an outer polythene sac.

In Ahmednagar, all women who provided their pad also got screened with Hybrid Capture 2 (HC2; Qiagen) by a mobile screening unit. In Pune, only the positive cases underwent HC2. Screening was also extended to anyone who requested it, but these people were not included in the final analysis.

Genomic DNA was extracted from three 5 mm–sized punches in the pad using a commercial kit, QIAamp DNA Micro, and the quality and purity of the DNA checked by Implen NanoPhotometer.

The team followed the same protocol for PCR HPV assay as the team from Hong Kong.

The results were published in the European Journal of Cancer Prevention in 2018.

The concordance rate for a positive result between the menstrual pad sample and conventional HPV sampling was 98.8% for Ahmednagar and 95.2% for samples from Pune. The sensitivity for the first study was 83% and the specificity 99% – similar to that for the women in Hong Kong. The second study had lower sensitivity and specificity (67% and 88%), partly because of poor storage as a result of frequent power cuts.

The total cost per woman was $30.78.

“I was very excited when we saw the results,” Dr. Budukh recalled. “That day I couldn’t sleep ... such a wonderful result! I was excited to start the next phase immediately.”

Dr. Budukh has applied to the Indian government for funding for a larger trial involving 3,000 women. If successful, he hopes such evidence would be sufficient to convince the Indian government to make menstrual pad screening standard procedure for the 390 million women who live in India’s countryside.

Testing never-screened women for cervical cancer using menstrual pads appears to be relatively reliable, convenient, private, noninvasive, and incredibly cheap.

So who else has tried it?

The first published account of HPV in menstrual blood was a 2003 study by Tommy Tong and colleagues at the Princess Margaret Hospital in Hong Kong. The authors heralded, with lamentable optimism, “a new paradigm in cervical cancer screening.”

In the following 20 years, just six more studies appeared: two from Dr. Budukh’s field trial in India and four from hospital-based pilot studies in Hong Kong (in 2010 and 2018), South Korea (in 2016), and mainland China (in 2021). All these studies, although small, were published in top-flight journals and demonstrate high concordance between conventional high-risk HPV testing and menstrual-blood tests.

This news organization tried to find a U.S. thought-leader who had heard of the approach.

Elizabeth Fontham, MPH, DrPh, is the founding dean of the school of public health at Louisiana State University Health Center in New Orleans, and president of the American Cancer Society. Dr. Fontham said in an email that she had “no plans to evaluate the impact related to menstrual pads, but perhaps others have looked into that.”

Joy Melnikow, MD, MPH, was first author on the evidence synthesis driving the current cervical cancer screening recommendations from the U.S. Preventive Services Task Force. When asked about menstrual pad testing for HPV, she said she had “not heard of it before.”

The USPSTF guidelines don’t mention sanitary pads but acknowledge that “self-collection may be one strategy for increasing screening rates among populations where they are currently low.”

The USPSTF methodology excludes data from countries that don’t match the United States on the Human Development Index “or [are] not applicable to U.S. clinical settings or populations.” (Presumably, data from Hong Kong and South Korea would qualify; Indian data would not.)

Dr. Sahasrabuddhe of the NCI hadn’t heard of menstrual pad testing either, but he has a different explanation for lack of interest in this approach – or, indeed, any form of self-sampling for cervical cancer screening – in the United States.

“We have not seen movement happen in this space for years. ... If there is one intervention that we can simplify, that still has not been made widely available, it is self-sampling ... [but] we don’t have [Food and Drug Administration] approval for it,” Dr. Sahasrabuddhe said.

“Our system, at least in the U.S., is based on industry manufacturers seeking an approval for a particular way of collection and then clinicians and clinical-guideline bodies signing on. ... For a lot of reasons industry has shied away over the past several years, so far, at least, on seeking approval for self-sampling-based approaches,” he commented.

Dr. Sahasrabuddhe aims to change that. He heads a new NCI-led initiative called “The Last Mile,” a nationwide clinical trial supported by federal agencies, industry partners, and professional societies. The goal is to validate self-sampled HPV testing as non-inferior to specimens collected by providers. The team is currently finalizing the methodology of the study, so Dr. Sahasrabuddhe could not share the self-sampling methods that will be on trial, nor the industry partners who have signed up.

The following tests are approved in the United States for physician-collected HPV screening: Hybrid Capture 2, used in the Indian studies (Qiagen); cobas HPV (Roche); Aptima (Hologic); Cervista (Hologic); and Onclarity (Becton Dickinson).

Dr. Sahasrabuddhe said that, while a sanitary pad in a Ziploc bag is unlikely to make the grade for The Last Mile study, he doesn’t totally dismiss their potential and said the NCI is always open to new ideas.

“We are not supporting anybody specifically for menstrual pad-based collection device development,” Dr. Sahasrabuddhe said, “But if they fulfill other criteria for a small business–based grant application, they absolutely are welcome to apply for NCI funding for this.”

Said Dr. Melnikow: “Pre-COVID, the head of [the World Health Organization] said that we could eliminate cervical cancer from the globe and that we have the tools to do that now. And he’s right.”

Dr. Budukh, Dr. Melnikow, and Dr. Sahasrabuddhe disclosed no relevant financial relationships.

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

Difficult economic times and the unpredictable consequences of health care reform are making an increasing number of solo practitioners and small private groups very nervous. Yet, many balk at the prospect of selling to private equity companies. I have received many inquiries about other protective options, such as merging two or more small practices into one larger entity.

Merging offers many benefits: Better overall management, centralized and efficient billing and collection, group purchasing discounts, and reduced overhead, among others; but careful planning, and a written agreement, are essential. If you are considering such an option, here are some things to think about.

You should begin with an evaluation and comparison of the separate groups’ respective finances. This should include a history of production, collections, overhead, and liabilities. Basically, you want to locate and identify all assets and liabilities that will be combined into the new group. One area of immediate importance is Medicare participation. Which members now currently participate and which do not? Since the new group will need to have a single position, all of the physicians must agree on that issue.

Who will be in charge? Not every physician is a qualified manager. The manager should be the physician who is willing to spend the time it takes to sign checks, interact with the administrator, and ensure that other matters such as filing tax returns and approving minor purchases arc carried out properly.

What is the compensation formula? Compensation arrangements should be based on each physician’s current financial data and the goals of the practice. Will everyone be paid only for what they do individually, or will revenue be shared equally? I favor a combination, so productivity is rewarded but your income doesn’t drop to zero when you take time off.

Which practices have a retirement plan and which do not? Will you keep your retirement plans separate, or combine them? If the latter, you will have to agree on the terms of the new plan, which can be the same or different from any of the existing plans. You’ll probably need some legal guidance to insure that assets from existing plans can be transferred into a new plan without tax issues. You may also have to address the problem of physicians who currently do not have a plan who, for whatever reason, may not want to be forced into making retirement plan contributions.

The often-problematic issue of employees and their salaries needs to be addressed, to decide which employees will be needed in the new group, and to determine a salary structure. Each practice’s policies related to vacation, sick leave, and other such issues should be reviewed, and an overall policy for the new group developed.

Other common sticking points are issues related to facilities. If the practices intend to consolidate into one location, the physicians must decide which of the specific assets of each practice will be contributed to the new entity. Ideally, each party brings an equal amount of assets to the table, but in the real world that is hardly ever the case. Physicians whose assets are to be used generally want to be compensated, and those who have to dispose of or store assets are in a quandary. The solution to this predicament will vary depending on the circumstances of each merger. One alternative is to agree that any inequalities will be compensated at the other end, in the form of buyout value; that is, physicians contributing more assets will receive larger buyouts when they leave or retire than those contributing less.

Buyouts should be addressed in advance as well. You must decide when a buyout would occur – usually in the event of retirement, death, disability, or withdrawal (voluntary or involuntary) – how the buyout amount will be calculated, and how it will be paid. Then, you must agree on how a buyout amount will be valued. Remember that any buyout calculated at “appraised value” is a problem, because the buyout amount remains a mystery until an appraisal is performed. If the appraised value ends up being too high, the remaining owners may refuse to pay it. I suggest having an actuary create a formula, so that the buyout figure can be calculated at any time. This area, especially, is where you need experienced, competent legal advice.

Noncompete provisions are always a difficult issue, mostly because they are so hard (and expensive) to enforce. An increasingly popular alternative is, once again, to deal with it at the other end, with a buyout penalty. An unhappy partner can leave, and compete, but at the cost of a substantially reduced buyout. This permits competition, but discourages it; and it compensates the remaining partners.

These are only some of the pivotal business and legal issues that must be settled in advance. A little planning and negotiation can prevent a lot of grief, regret, and legal expenses in the future. I’ll discuss some other, more complicated merger options in my next column.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

Difficult economic times and the unpredictable consequences of health care reform are making an increasing number of solo practitioners and small private groups very nervous. Yet, many balk at the prospect of selling to private equity companies. I have received many inquiries about other protective options, such as merging two or more small practices into one larger entity.

Merging offers many benefits: Better overall management, centralized and efficient billing and collection, group purchasing discounts, and reduced overhead, among others; but careful planning, and a written agreement, are essential. If you are considering such an option, here are some things to think about.

You should begin with an evaluation and comparison of the separate groups’ respective finances. This should include a history of production, collections, overhead, and liabilities. Basically, you want to locate and identify all assets and liabilities that will be combined into the new group. One area of immediate importance is Medicare participation. Which members now currently participate and which do not? Since the new group will need to have a single position, all of the physicians must agree on that issue.

Who will be in charge? Not every physician is a qualified manager. The manager should be the physician who is willing to spend the time it takes to sign checks, interact with the administrator, and ensure that other matters such as filing tax returns and approving minor purchases arc carried out properly.

What is the compensation formula? Compensation arrangements should be based on each physician’s current financial data and the goals of the practice. Will everyone be paid only for what they do individually, or will revenue be shared equally? I favor a combination, so productivity is rewarded but your income doesn’t drop to zero when you take time off.

Which practices have a retirement plan and which do not? Will you keep your retirement plans separate, or combine them? If the latter, you will have to agree on the terms of the new plan, which can be the same or different from any of the existing plans. You’ll probably need some legal guidance to insure that assets from existing plans can be transferred into a new plan without tax issues. You may also have to address the problem of physicians who currently do not have a plan who, for whatever reason, may not want to be forced into making retirement plan contributions.

The often-problematic issue of employees and their salaries needs to be addressed, to decide which employees will be needed in the new group, and to determine a salary structure. Each practice’s policies related to vacation, sick leave, and other such issues should be reviewed, and an overall policy for the new group developed.

Other common sticking points are issues related to facilities. If the practices intend to consolidate into one location, the physicians must decide which of the specific assets of each practice will be contributed to the new entity. Ideally, each party brings an equal amount of assets to the table, but in the real world that is hardly ever the case. Physicians whose assets are to be used generally want to be compensated, and those who have to dispose of or store assets are in a quandary. The solution to this predicament will vary depending on the circumstances of each merger. One alternative is to agree that any inequalities will be compensated at the other end, in the form of buyout value; that is, physicians contributing more assets will receive larger buyouts when they leave or retire than those contributing less.

Buyouts should be addressed in advance as well. You must decide when a buyout would occur – usually in the event of retirement, death, disability, or withdrawal (voluntary or involuntary) – how the buyout amount will be calculated, and how it will be paid. Then, you must agree on how a buyout amount will be valued. Remember that any buyout calculated at “appraised value” is a problem, because the buyout amount remains a mystery until an appraisal is performed. If the appraised value ends up being too high, the remaining owners may refuse to pay it. I suggest having an actuary create a formula, so that the buyout figure can be calculated at any time. This area, especially, is where you need experienced, competent legal advice.

Noncompete provisions are always a difficult issue, mostly because they are so hard (and expensive) to enforce. An increasingly popular alternative is, once again, to deal with it at the other end, with a buyout penalty. An unhappy partner can leave, and compete, but at the cost of a substantially reduced buyout. This permits competition, but discourages it; and it compensates the remaining partners.

These are only some of the pivotal business and legal issues that must be settled in advance. A little planning and negotiation can prevent a lot of grief, regret, and legal expenses in the future. I’ll discuss some other, more complicated merger options in my next column.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

Difficult economic times and the unpredictable consequences of health care reform are making an increasing number of solo practitioners and small private groups very nervous. Yet, many balk at the prospect of selling to private equity companies. I have received many inquiries about other protective options, such as merging two or more small practices into one larger entity.

Merging offers many benefits: Better overall management, centralized and efficient billing and collection, group purchasing discounts, and reduced overhead, among others; but careful planning, and a written agreement, are essential. If you are considering such an option, here are some things to think about.

You should begin with an evaluation and comparison of the separate groups’ respective finances. This should include a history of production, collections, overhead, and liabilities. Basically, you want to locate and identify all assets and liabilities that will be combined into the new group. One area of immediate importance is Medicare participation. Which members now currently participate and which do not? Since the new group will need to have a single position, all of the physicians must agree on that issue.

Who will be in charge? Not every physician is a qualified manager. The manager should be the physician who is willing to spend the time it takes to sign checks, interact with the administrator, and ensure that other matters such as filing tax returns and approving minor purchases arc carried out properly.

What is the compensation formula? Compensation arrangements should be based on each physician’s current financial data and the goals of the practice. Will everyone be paid only for what they do individually, or will revenue be shared equally? I favor a combination, so productivity is rewarded but your income doesn’t drop to zero when you take time off.

Which practices have a retirement plan and which do not? Will you keep your retirement plans separate, or combine them? If the latter, you will have to agree on the terms of the new plan, which can be the same or different from any of the existing plans. You’ll probably need some legal guidance to insure that assets from existing plans can be transferred into a new plan without tax issues. You may also have to address the problem of physicians who currently do not have a plan who, for whatever reason, may not want to be forced into making retirement plan contributions.

The often-problematic issue of employees and their salaries needs to be addressed, to decide which employees will be needed in the new group, and to determine a salary structure. Each practice’s policies related to vacation, sick leave, and other such issues should be reviewed, and an overall policy for the new group developed.

Other common sticking points are issues related to facilities. If the practices intend to consolidate into one location, the physicians must decide which of the specific assets of each practice will be contributed to the new entity. Ideally, each party brings an equal amount of assets to the table, but in the real world that is hardly ever the case. Physicians whose assets are to be used generally want to be compensated, and those who have to dispose of or store assets are in a quandary. The solution to this predicament will vary depending on the circumstances of each merger. One alternative is to agree that any inequalities will be compensated at the other end, in the form of buyout value; that is, physicians contributing more assets will receive larger buyouts when they leave or retire than those contributing less.

Buyouts should be addressed in advance as well. You must decide when a buyout would occur – usually in the event of retirement, death, disability, or withdrawal (voluntary or involuntary) – how the buyout amount will be calculated, and how it will be paid. Then, you must agree on how a buyout amount will be valued. Remember that any buyout calculated at “appraised value” is a problem, because the buyout amount remains a mystery until an appraisal is performed. If the appraised value ends up being too high, the remaining owners may refuse to pay it. I suggest having an actuary create a formula, so that the buyout figure can be calculated at any time. This area, especially, is where you need experienced, competent legal advice.

Noncompete provisions are always a difficult issue, mostly because they are so hard (and expensive) to enforce. An increasingly popular alternative is, once again, to deal with it at the other end, with a buyout penalty. An unhappy partner can leave, and compete, but at the cost of a substantially reduced buyout. This permits competition, but discourages it; and it compensates the remaining partners.

These are only some of the pivotal business and legal issues that must be settled in advance. A little planning and negotiation can prevent a lot of grief, regret, and legal expenses in the future. I’ll discuss some other, more complicated merger options in my next column.

Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].

During the first year of the pandemic, at least four people in Michigan were infected with a coronavirus variant that has been found in mink.

The cluster, which previously included three cases, marks the first known instance of likely animal-to-human “spillover” of the virus in the United States, according to the New York Times. All four people fully recovered.

Two of the infected people were employees of a mink farm in Michigan that had an outbreak in October 2020. The other two people didn’t have known links to the farm, which may mean that the coronavirus variant among mink may have been circulating more widely among residents in that area during that time.

Virus samples from all four people contained two mutations that may show signs of an adaptation to mink. The mutations have also been documented in farmed mink in Europe and people with connections to those farms.

“This, in addition to the mink farmworkers testing positive for COVID-19 after the mink herd had begun experiencing illness and increased mortality, suggests that the most likely hypothesis is that the workers were infected after contact with mink on the farm,” Casey Barton Behravesh, DVM, who directs the Centers for Disease Control and Prevention’s One Health Office, told the newspaper.

But researchers are unable to prove the cause, she noted.

“Because there are few genetic sequences available from the communities around the farm, it is impossible to know for sure whether the mutations came from mink on the farm or were already circulating in the community,” she said.

In August 2020, the U.S. Department of Agriculture announced the first confirmed COVID-19 case in mink at farms in Utah, followed by a case in Wisconsin. Worldwide, the coronavirus has been detected in mink on farms in the Netherlands, Denmark, Poland, and Spain.

In early October 2020, Michigan officials announced that the coronavirus had been detected in mink on a local farm. Several of the animals had died. The CDC helped to investigate the outbreak by collecting samples from animals, farmworkers, and residents in the community.

By March 2021, the CDC had updated its website to note that a “small number of people” had contracted a coronavirus variant that “contained unique mink-related mutations.”

In April 2021, the Detroit Free Press and the Documenting COVID-19 project first reported on the first three cases – two farmworkers and a taxidermist who didn’t have a connection to the mink farm. This week, the news outlets reported an update that the fourth case was the taxidermist’s wife.

Earlier this month, National Geographic first reported on the fourth human case based on government documents about the mink farm outbreak.

Overall, animal-to-human transmission is rare, but the CDC is continuing to monitor potential coronavirus cases in wildlife, livestock, and zoo animals for new variants and virus reservoirs, the Times reported.

“These results highlight the importance of routinely studying the genetic material of SARS-CoV-2 in susceptible animal populations like mink, as well as in people,” the CDC wrote.

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

During the first year of the pandemic, at least four people in Michigan were infected with a coronavirus variant that has been found in mink.

The cluster, which previously included three cases, marks the first known instance of likely animal-to-human “spillover” of the virus in the United States, according to the New York Times. All four people fully recovered.

Two of the infected people were employees of a mink farm in Michigan that had an outbreak in October 2020. The other two people didn’t have known links to the farm, which may mean that the coronavirus variant among mink may have been circulating more widely among residents in that area during that time.

Virus samples from all four people contained two mutations that may show signs of an adaptation to mink. The mutations have also been documented in farmed mink in Europe and people with connections to those farms.

“This, in addition to the mink farmworkers testing positive for COVID-19 after the mink herd had begun experiencing illness and increased mortality, suggests that the most likely hypothesis is that the workers were infected after contact with mink on the farm,” Casey Barton Behravesh, DVM, who directs the Centers for Disease Control and Prevention’s One Health Office, told the newspaper.

But researchers are unable to prove the cause, she noted.

“Because there are few genetic sequences available from the communities around the farm, it is impossible to know for sure whether the mutations came from mink on the farm or were already circulating in the community,” she said.

In August 2020, the U.S. Department of Agriculture announced the first confirmed COVID-19 case in mink at farms in Utah, followed by a case in Wisconsin. Worldwide, the coronavirus has been detected in mink on farms in the Netherlands, Denmark, Poland, and Spain.

In early October 2020, Michigan officials announced that the coronavirus had been detected in mink on a local farm. Several of the animals had died. The CDC helped to investigate the outbreak by collecting samples from animals, farmworkers, and residents in the community.

By March 2021, the CDC had updated its website to note that a “small number of people” had contracted a coronavirus variant that “contained unique mink-related mutations.”

In April 2021, the Detroit Free Press and the Documenting COVID-19 project first reported on the first three cases – two farmworkers and a taxidermist who didn’t have a connection to the mink farm. This week, the news outlets reported an update that the fourth case was the taxidermist’s wife.

Earlier this month, National Geographic first reported on the fourth human case based on government documents about the mink farm outbreak.

Overall, animal-to-human transmission is rare, but the CDC is continuing to monitor potential coronavirus cases in wildlife, livestock, and zoo animals for new variants and virus reservoirs, the Times reported.

“These results highlight the importance of routinely studying the genetic material of SARS-CoV-2 in susceptible animal populations like mink, as well as in people,” the CDC wrote.

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

During the first year of the pandemic, at least four people in Michigan were infected with a coronavirus variant that has been found in mink.

The cluster, which previously included three cases, marks the first known instance of likely animal-to-human “spillover” of the virus in the United States, according to the New York Times. All four people fully recovered.

Two of the infected people were employees of a mink farm in Michigan that had an outbreak in October 2020. The other two people didn’t have known links to the farm, which may mean that the coronavirus variant among mink may have been circulating more widely among residents in that area during that time.

Virus samples from all four people contained two mutations that may show signs of an adaptation to mink. The mutations have also been documented in farmed mink in Europe and people with connections to those farms.

“This, in addition to the mink farmworkers testing positive for COVID-19 after the mink herd had begun experiencing illness and increased mortality, suggests that the most likely hypothesis is that the workers were infected after contact with mink on the farm,” Casey Barton Behravesh, DVM, who directs the Centers for Disease Control and Prevention’s One Health Office, told the newspaper.

But researchers are unable to prove the cause, she noted.

“Because there are few genetic sequences available from the communities around the farm, it is impossible to know for sure whether the mutations came from mink on the farm or were already circulating in the community,” she said.

In August 2020, the U.S. Department of Agriculture announced the first confirmed COVID-19 case in mink at farms in Utah, followed by a case in Wisconsin. Worldwide, the coronavirus has been detected in mink on farms in the Netherlands, Denmark, Poland, and Spain.

In early October 2020, Michigan officials announced that the coronavirus had been detected in mink on a local farm. Several of the animals had died. The CDC helped to investigate the outbreak by collecting samples from animals, farmworkers, and residents in the community.

By March 2021, the CDC had updated its website to note that a “small number of people” had contracted a coronavirus variant that “contained unique mink-related mutations.”

In April 2021, the Detroit Free Press and the Documenting COVID-19 project first reported on the first three cases – two farmworkers and a taxidermist who didn’t have a connection to the mink farm. This week, the news outlets reported an update that the fourth case was the taxidermist’s wife.

Earlier this month, National Geographic first reported on the fourth human case based on government documents about the mink farm outbreak.

Overall, animal-to-human transmission is rare, but the CDC is continuing to monitor potential coronavirus cases in wildlife, livestock, and zoo animals for new variants and virus reservoirs, the Times reported.

“These results highlight the importance of routinely studying the genetic material of SARS-CoV-2 in susceptible animal populations like mink, as well as in people,” the CDC wrote.

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

Emotional or sexual abuse in childhood may increase risk of multiple sclerosis (MS) in women, and risk may increase further with exposure to multiple kinds of abuse, according to the first prospective cohort study of its kind.

More research is needed to uncover underlying mechanisms of action, according to lead author Karine Eid, MD, a PhD candidate at Haukeland University Hospital, Bergen, Norway, and colleagues.

“Trauma and stressful life events have been associated with an increased risk of autoimmune disorders,” the investigators wrote in the Journal Of Neurology, Neurosurgery, & Psychiatry. “Whether adverse events in childhood can have an impact on MS susceptibility is not known.”

The present study recruited participants from the Norwegian Mother, Father and Child cohort, a population consisting of Norwegian women who were pregnant from 1999 to 2008. Of the 77,997 participating women, 14,477 reported emotional, sexual, and/or physical abuse in childhood, while the remaining 63,520 women reported no abuse. After a mean follow-up of 13 years, 300 women were diagnosed with MS, among whom 24% reported a history of childhood abuse, compared with 19% among women who did not develop MS.

To look for associations between childhood abuse and risk of MS, the investigators used a Cox model adjusted for confounders and mediators, including smoking, obesity, adult socioeconomic factors, and childhood social status. The model revealed that emotional abuse increased the risk of MS by 40% (hazard ratio [HR] 1.40; 95% confidence interval [CI], 1.03-1.90), and sexual abuse increased the risk of MS by 65% (HR 1.65; 95% CI, 1.13-2.39).

Although physical abuse alone did not significantly increase risk of MS (HR 1.31; 95% CI, 0.83-2.06), it did contribute to a dose-response relationship when women were exposed to more than one type of childhood abuse. Women exposed to two out of three abuse categories had a 66% increased risk of MS (HR 1.66; 95% CI, 1.04-2.67), whereas women exposed to all three types of abuse had the highest risk of MS, at 93% (HR 1.93; 95% CI, 1.02-3.67).

Dr. Eid and colleagues noted that their findings are supported by previous retrospective research, and discussed possible mechanisms of action.

“The increased risk of MS after exposure to childhood sexual and emotional abuse may have a biological explanation,” they wrote. “Childhood abuse can cause dysregulation of the hypothalamic-pituitary-adrenal axis, lead to oxidative stress, and induce a proinflammatory state decades into adulthood. Psychological stress has been shown to disrupt the blood-brain barrier and cause epigenetic changes that may increase the risk of neurodegenerative disorders, including MS.

“The underlying mechanisms behind this association should be investigated further,” they concluded.
 

Study findings should guide interventions

Commenting on the research, Ruth Ann Marrie, MD, PhD, professor of medicine and community health sciences and director of the multiple sclerosis clinic at Max Rady College of Medicine, Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, said that the present study “has several strengths compared to prior studies – including that it is prospective and the sample size.”

Dr. Marrie, who was not involved in the study, advised clinicians in the field to take note of the findings, as patients with a history of abuse may need unique interventions.

“Providers need to recognize the higher prevalence of childhood maltreatment in people with MS,” Dr. Marrie said in an interview. “These findings dovetail with others that suggest that adverse childhood experiences are associated with increased mental health concerns and pain catastrophizing in people with MS. Affected individuals may benefit from additional psychological supports and trauma-informed care.”

Tiffany Joy Braley, MD, associate professor of neurology, and Carri Polick, RN and PhD candidate at the school of nursing, University of Michigan, Ann Arbor, who published a case report last year highlighting the importance of evaluating stress exposure in MS, suggested that the findings should guide interventions at both a system and patient level.

“Although a cause-and-effect relationship cannot be established by the current study, these and related findings should be considered in the context of system level and policy interventions that address links between environment and health care disparities,” they said in a joint, written comment. “Given recent impetus to provide trauma-informed health care, these data could be particularly informative in neurological conditions which are associated with high mental health comorbidity. Traumatic stress screening practices could lead to referrals for appropriate support services and more personalized health care.”

While several mechanisms have been proposed to explain the link between traumatic stress and MS, more work is needed in this area, they added.

This knowledge gap was acknowledged by Dr. Marrie.

“Our understanding of the etiology of MS remains incomplete,” Dr. Marrie said. “We still need a better understanding of mechanisms by which adverse childhood experiences lead to MS, how they interact with other risk factors for MS (beyond smoking and obesity), and whether there are any interventions that can mitigate the risk of developing MS that is associated with adverse childhood experiences.”

The investigators disclosed relationships with Novartis, Biogen, Merck, and others. Dr. Marrie receives research support from the Canadian Institutes of Health Research, the National Multiple Sclerosis Society, MS Society of Canada, the Consortium of Multiple Sclerosis Centers, Crohn’s and Colitis Canada, Research Manitoba, and the Arthritis Society; she has no pharmaceutical support. Dr. Braley and Ms. Polick reported no conflicts of interest.

Emotional or sexual abuse in childhood may increase risk of multiple sclerosis (MS) in women, and risk may increase further with exposure to multiple kinds of abuse, according to the first prospective cohort study of its kind.

More research is needed to uncover underlying mechanisms of action, according to lead author Karine Eid, MD, a PhD candidate at Haukeland University Hospital, Bergen, Norway, and colleagues.

“Trauma and stressful life events have been associated with an increased risk of autoimmune disorders,” the investigators wrote in the Journal Of Neurology, Neurosurgery, & Psychiatry. “Whether adverse events in childhood can have an impact on MS susceptibility is not known.”

The present study recruited participants from the Norwegian Mother, Father and Child cohort, a population consisting of Norwegian women who were pregnant from 1999 to 2008. Of the 77,997 participating women, 14,477 reported emotional, sexual, and/or physical abuse in childhood, while the remaining 63,520 women reported no abuse. After a mean follow-up of 13 years, 300 women were diagnosed with MS, among whom 24% reported a history of childhood abuse, compared with 19% among women who did not develop MS.

To look for associations between childhood abuse and risk of MS, the investigators used a Cox model adjusted for confounders and mediators, including smoking, obesity, adult socioeconomic factors, and childhood social status. The model revealed that emotional abuse increased the risk of MS by 40% (hazard ratio [HR] 1.40; 95% confidence interval [CI], 1.03-1.90), and sexual abuse increased the risk of MS by 65% (HR 1.65; 95% CI, 1.13-2.39).

Although physical abuse alone did not significantly increase risk of MS (HR 1.31; 95% CI, 0.83-2.06), it did contribute to a dose-response relationship when women were exposed to more than one type of childhood abuse. Women exposed to two out of three abuse categories had a 66% increased risk of MS (HR 1.66; 95% CI, 1.04-2.67), whereas women exposed to all three types of abuse had the highest risk of MS, at 93% (HR 1.93; 95% CI, 1.02-3.67).

Dr. Eid and colleagues noted that their findings are supported by previous retrospective research, and discussed possible mechanisms of action.

“The increased risk of MS after exposure to childhood sexual and emotional abuse may have a biological explanation,” they wrote. “Childhood abuse can cause dysregulation of the hypothalamic-pituitary-adrenal axis, lead to oxidative stress, and induce a proinflammatory state decades into adulthood. Psychological stress has been shown to disrupt the blood-brain barrier and cause epigenetic changes that may increase the risk of neurodegenerative disorders, including MS.

“The underlying mechanisms behind this association should be investigated further,” they concluded.
 

Study findings should guide interventions

Commenting on the research, Ruth Ann Marrie, MD, PhD, professor of medicine and community health sciences and director of the multiple sclerosis clinic at Max Rady College of Medicine, Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, said that the present study “has several strengths compared to prior studies – including that it is prospective and the sample size.”

Dr. Marrie, who was not involved in the study, advised clinicians in the field to take note of the findings, as patients with a history of abuse may need unique interventions.

“Providers need to recognize the higher prevalence of childhood maltreatment in people with MS,” Dr. Marrie said in an interview. “These findings dovetail with others that suggest that adverse childhood experiences are associated with increased mental health concerns and pain catastrophizing in people with MS. Affected individuals may benefit from additional psychological supports and trauma-informed care.”

Tiffany Joy Braley, MD, associate professor of neurology, and Carri Polick, RN and PhD candidate at the school of nursing, University of Michigan, Ann Arbor, who published a case report last year highlighting the importance of evaluating stress exposure in MS, suggested that the findings should guide interventions at both a system and patient level.

“Although a cause-and-effect relationship cannot be established by the current study, these and related findings should be considered in the context of system level and policy interventions that address links between environment and health care disparities,” they said in a joint, written comment. “Given recent impetus to provide trauma-informed health care, these data could be particularly informative in neurological conditions which are associated with high mental health comorbidity. Traumatic stress screening practices could lead to referrals for appropriate support services and more personalized health care.”

While several mechanisms have been proposed to explain the link between traumatic stress and MS, more work is needed in this area, they added.

This knowledge gap was acknowledged by Dr. Marrie.

“Our understanding of the etiology of MS remains incomplete,” Dr. Marrie said. “We still need a better understanding of mechanisms by which adverse childhood experiences lead to MS, how they interact with other risk factors for MS (beyond smoking and obesity), and whether there are any interventions that can mitigate the risk of developing MS that is associated with adverse childhood experiences.”

The investigators disclosed relationships with Novartis, Biogen, Merck, and others. Dr. Marrie receives research support from the Canadian Institutes of Health Research, the National Multiple Sclerosis Society, MS Society of Canada, the Consortium of Multiple Sclerosis Centers, Crohn’s and Colitis Canada, Research Manitoba, and the Arthritis Society; she has no pharmaceutical support. Dr. Braley and Ms. Polick reported no conflicts of interest.

Emotional or sexual abuse in childhood may increase risk of multiple sclerosis (MS) in women, and risk may increase further with exposure to multiple kinds of abuse, according to the first prospective cohort study of its kind.

More research is needed to uncover underlying mechanisms of action, according to lead author Karine Eid, MD, a PhD candidate at Haukeland University Hospital, Bergen, Norway, and colleagues.

“Trauma and stressful life events have been associated with an increased risk of autoimmune disorders,” the investigators wrote in the Journal Of Neurology, Neurosurgery, & Psychiatry. “Whether adverse events in childhood can have an impact on MS susceptibility is not known.”

The present study recruited participants from the Norwegian Mother, Father and Child cohort, a population consisting of Norwegian women who were pregnant from 1999 to 2008. Of the 77,997 participating women, 14,477 reported emotional, sexual, and/or physical abuse in childhood, while the remaining 63,520 women reported no abuse. After a mean follow-up of 13 years, 300 women were diagnosed with MS, among whom 24% reported a history of childhood abuse, compared with 19% among women who did not develop MS.

To look for associations between childhood abuse and risk of MS, the investigators used a Cox model adjusted for confounders and mediators, including smoking, obesity, adult socioeconomic factors, and childhood social status. The model revealed that emotional abuse increased the risk of MS by 40% (hazard ratio [HR] 1.40; 95% confidence interval [CI], 1.03-1.90), and sexual abuse increased the risk of MS by 65% (HR 1.65; 95% CI, 1.13-2.39).

Although physical abuse alone did not significantly increase risk of MS (HR 1.31; 95% CI, 0.83-2.06), it did contribute to a dose-response relationship when women were exposed to more than one type of childhood abuse. Women exposed to two out of three abuse categories had a 66% increased risk of MS (HR 1.66; 95% CI, 1.04-2.67), whereas women exposed to all three types of abuse had the highest risk of MS, at 93% (HR 1.93; 95% CI, 1.02-3.67).

Dr. Eid and colleagues noted that their findings are supported by previous retrospective research, and discussed possible mechanisms of action.

“The increased risk of MS after exposure to childhood sexual and emotional abuse may have a biological explanation,” they wrote. “Childhood abuse can cause dysregulation of the hypothalamic-pituitary-adrenal axis, lead to oxidative stress, and induce a proinflammatory state decades into adulthood. Psychological stress has been shown to disrupt the blood-brain barrier and cause epigenetic changes that may increase the risk of neurodegenerative disorders, including MS.

“The underlying mechanisms behind this association should be investigated further,” they concluded.
 

Study findings should guide interventions

Commenting on the research, Ruth Ann Marrie, MD, PhD, professor of medicine and community health sciences and director of the multiple sclerosis clinic at Max Rady College of Medicine, Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, said that the present study “has several strengths compared to prior studies – including that it is prospective and the sample size.”

Dr. Marrie, who was not involved in the study, advised clinicians in the field to take note of the findings, as patients with a history of abuse may need unique interventions.

“Providers need to recognize the higher prevalence of childhood maltreatment in people with MS,” Dr. Marrie said in an interview. “These findings dovetail with others that suggest that adverse childhood experiences are associated with increased mental health concerns and pain catastrophizing in people with MS. Affected individuals may benefit from additional psychological supports and trauma-informed care.”

Tiffany Joy Braley, MD, associate professor of neurology, and Carri Polick, RN and PhD candidate at the school of nursing, University of Michigan, Ann Arbor, who published a case report last year highlighting the importance of evaluating stress exposure in MS, suggested that the findings should guide interventions at both a system and patient level.

“Although a cause-and-effect relationship cannot be established by the current study, these and related findings should be considered in the context of system level and policy interventions that address links between environment and health care disparities,” they said in a joint, written comment. “Given recent impetus to provide trauma-informed health care, these data could be particularly informative in neurological conditions which are associated with high mental health comorbidity. Traumatic stress screening practices could lead to referrals for appropriate support services and more personalized health care.”

While several mechanisms have been proposed to explain the link between traumatic stress and MS, more work is needed in this area, they added.

This knowledge gap was acknowledged by Dr. Marrie.

“Our understanding of the etiology of MS remains incomplete,” Dr. Marrie said. “We still need a better understanding of mechanisms by which adverse childhood experiences lead to MS, how they interact with other risk factors for MS (beyond smoking and obesity), and whether there are any interventions that can mitigate the risk of developing MS that is associated with adverse childhood experiences.”

The investigators disclosed relationships with Novartis, Biogen, Merck, and others. Dr. Marrie receives research support from the Canadian Institutes of Health Research, the National Multiple Sclerosis Society, MS Society of Canada, the Consortium of Multiple Sclerosis Centers, Crohn’s and Colitis Canada, Research Manitoba, and the Arthritis Society; she has no pharmaceutical support. Dr. Braley and Ms. Polick reported no conflicts of interest.

Across the country, taxes unite us. Not that we all share the same, rather that we all have to do them. It was recently tax weekend in our house: The Saturday and Sunday that cap off weeks of hunting and gathering faded receipts and sorting through reams of credit card bills to find all the dollars we spent on work. The task is more tedious than all the Wednesdays of taking out trash bins combined, and equally as exciting. But wait, that’s not all.

This weekend I’ve been chatting with bots from a solar company trying to solve our drop in energy production and sat on terminal hold with apparently one person who answers the phone for Amazon. There’s also an homeowner’s association meeting to prepare for and research to be done on ceiling fans.

“Life admin” is a crisp phrase coined by Elizabeth Emens, JD, PhD, that captures the never-ending to-do list that comes with running a household. An accomplished law professor at Columbia University, New York, Dr. Emens noticed the negative impact this life admin has on our quality of life. Reading her book, “Life Admin: How I Learned to Do Less, Do Better, and Live More” (New York: HarperOne, 2019), your eyes widen as she magically makes salient all this hidden work that is stealing our time. Life admin, kidmin, mom and dadmin, just rattling them off feels like donning x-ray glasses allowing us to see how much work we do outside of our work. As doctors, I would add “family house calls,” as a contributing factor: Random family and friends who want to talk for a minute about their knee replacement or what drug the ICU should give Uncle Larry who is fighting COVID. (I only know ivermectin, but it would only help if he just had scabies).

By all accounts, the amount of life admin is growing insidiously, worsened by the great pandemic. There are events to plan and reply to, more DIY customer service to fix your own problems, more work to find a VRBO for a weekend getaway at the beach. (There are none on the entire coast of California this summer, so I just saved you time there. You’re welcome.)

There is no good time to do this work and combined with the heavy burden of our responsibilities as physicians, it can feel like fuel feeding the burnout fire.

Dr. Emens has some top tips to help. First up, know your admin type. Are you a super doer, reluctant doer, admin denier, or admin avoider? I’m mostly in the avoider quadrant, dropping into reluctant doer when consequences loom. Next, choose strategies that fit you. Instead of avoiding, there are some things I might deflect. For example, When your aunt in Peoria asks where she can get a COVID test, you can use LMGTFY.com to generate a link that will show them how to use Google to help with their question. Dr. Emens is joking, but the point rang true. We can lighten the load a bit if we delegate or push back the excessive or undue requests. For some tasks, we’d be better off paying someone to take it over. Last tip here, try doing life admin with a partner, be it spouse, friend, or colleague. This is particularly useful when your partner is a super doer, as mine is. Not only can they make the work lighter, but also less dreary.

We physicians are focused on fixing physician burnout. Maybe we should also be looking at what happens in the “second shift” at home. Tax season is over, but will be back soon.

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected]

Across the country, taxes unite us. Not that we all share the same, rather that we all have to do them. It was recently tax weekend in our house: The Saturday and Sunday that cap off weeks of hunting and gathering faded receipts and sorting through reams of credit card bills to find all the dollars we spent on work. The task is more tedious than all the Wednesdays of taking out trash bins combined, and equally as exciting. But wait, that’s not all.

This weekend I’ve been chatting with bots from a solar company trying to solve our drop in energy production and sat on terminal hold with apparently one person who answers the phone for Amazon. There’s also an homeowner’s association meeting to prepare for and research to be done on ceiling fans.

“Life admin” is a crisp phrase coined by Elizabeth Emens, JD, PhD, that captures the never-ending to-do list that comes with running a household. An accomplished law professor at Columbia University, New York, Dr. Emens noticed the negative impact this life admin has on our quality of life. Reading her book, “Life Admin: How I Learned to Do Less, Do Better, and Live More” (New York: HarperOne, 2019), your eyes widen as she magically makes salient all this hidden work that is stealing our time. Life admin, kidmin, mom and dadmin, just rattling them off feels like donning x-ray glasses allowing us to see how much work we do outside of our work. As doctors, I would add “family house calls,” as a contributing factor: Random family and friends who want to talk for a minute about their knee replacement or what drug the ICU should give Uncle Larry who is fighting COVID. (I only know ivermectin, but it would only help if he just had scabies).

By all accounts, the amount of life admin is growing insidiously, worsened by the great pandemic. There are events to plan and reply to, more DIY customer service to fix your own problems, more work to find a VRBO for a weekend getaway at the beach. (There are none on the entire coast of California this summer, so I just saved you time there. You’re welcome.)

There is no good time to do this work and combined with the heavy burden of our responsibilities as physicians, it can feel like fuel feeding the burnout fire.

Dr. Emens has some top tips to help. First up, know your admin type. Are you a super doer, reluctant doer, admin denier, or admin avoider? I’m mostly in the avoider quadrant, dropping into reluctant doer when consequences loom. Next, choose strategies that fit you. Instead of avoiding, there are some things I might deflect. For example, When your aunt in Peoria asks where she can get a COVID test, you can use LMGTFY.com to generate a link that will show them how to use Google to help with their question. Dr. Emens is joking, but the point rang true. We can lighten the load a bit if we delegate or push back the excessive or undue requests. For some tasks, we’d be better off paying someone to take it over. Last tip here, try doing life admin with a partner, be it spouse, friend, or colleague. This is particularly useful when your partner is a super doer, as mine is. Not only can they make the work lighter, but also less dreary.

We physicians are focused on fixing physician burnout. Maybe we should also be looking at what happens in the “second shift” at home. Tax season is over, but will be back soon.

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected]

Across the country, taxes unite us. Not that we all share the same, rather that we all have to do them. It was recently tax weekend in our house: The Saturday and Sunday that cap off weeks of hunting and gathering faded receipts and sorting through reams of credit card bills to find all the dollars we spent on work. The task is more tedious than all the Wednesdays of taking out trash bins combined, and equally as exciting. But wait, that’s not all.

This weekend I’ve been chatting with bots from a solar company trying to solve our drop in energy production and sat on terminal hold with apparently one person who answers the phone for Amazon. There’s also an homeowner’s association meeting to prepare for and research to be done on ceiling fans.

“Life admin” is a crisp phrase coined by Elizabeth Emens, JD, PhD, that captures the never-ending to-do list that comes with running a household. An accomplished law professor at Columbia University, New York, Dr. Emens noticed the negative impact this life admin has on our quality of life. Reading her book, “Life Admin: How I Learned to Do Less, Do Better, and Live More” (New York: HarperOne, 2019), your eyes widen as she magically makes salient all this hidden work that is stealing our time. Life admin, kidmin, mom and dadmin, just rattling them off feels like donning x-ray glasses allowing us to see how much work we do outside of our work. As doctors, I would add “family house calls,” as a contributing factor: Random family and friends who want to talk for a minute about their knee replacement or what drug the ICU should give Uncle Larry who is fighting COVID. (I only know ivermectin, but it would only help if he just had scabies).

By all accounts, the amount of life admin is growing insidiously, worsened by the great pandemic. There are events to plan and reply to, more DIY customer service to fix your own problems, more work to find a VRBO for a weekend getaway at the beach. (There are none on the entire coast of California this summer, so I just saved you time there. You’re welcome.)

There is no good time to do this work and combined with the heavy burden of our responsibilities as physicians, it can feel like fuel feeding the burnout fire.

Dr. Emens has some top tips to help. First up, know your admin type. Are you a super doer, reluctant doer, admin denier, or admin avoider? I’m mostly in the avoider quadrant, dropping into reluctant doer when consequences loom. Next, choose strategies that fit you. Instead of avoiding, there are some things I might deflect. For example, When your aunt in Peoria asks where she can get a COVID test, you can use LMGTFY.com to generate a link that will show them how to use Google to help with their question. Dr. Emens is joking, but the point rang true. We can lighten the load a bit if we delegate or push back the excessive or undue requests. For some tasks, we’d be better off paying someone to take it over. Last tip here, try doing life admin with a partner, be it spouse, friend, or colleague. This is particularly useful when your partner is a super doer, as mine is. Not only can they make the work lighter, but also less dreary.

We physicians are focused on fixing physician burnout. Maybe we should also be looking at what happens in the “second shift” at home. Tax season is over, but will be back soon.

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected]

Although it disputed the allegations, Saint James School of Medicine has settled a complaint with the Federal Trade Commission that the school used deceptive marketing tactics to lure students. The complaint referenced the school’s medical license exam test pass rate and residency matches along with violations of rules that protect consumers, including those dealing with credit contracts.

The school, based in the Caribbean with operations in Illinois, agreed to pay $1.2 million toward refunds and debt cancellation for students harmed by the marketing in the past 5 years.

“While we strongly disagree with the FTC’s approach to this matter, we did not want a lengthy legal process to distract from our mission of providing a quality medical education at an affordable cost,” Kaushik Guha, executive vice president of the parent of the school, Human Resources Development Services, said in a YouTube statement posted on the school’s website.

“Saint James lured students by lying about their chances of success,” Samuel Levine, director of the FTC’s Bureau of Consumer Protection, said in a press release. The settlement agreement was with HRDS, which bills itself as providing students from “non-traditional backgrounds the opportunity to pursue a medical degree and practice in the U.S. or Canada,” according to the school’s statement.

The complaint alleges that, since at least April 2018, the school, HRDS, and its operator Mr. Guha has lured students using “phony claims about the standardized test pass rate and students’ residency or job prospects. They lured consumers with false guarantees of student success at passing a critical medical school standardized test, the United States Medical Licensing Examination Step 1 Exam.”

For example, a brochure distributed at open houses claimed a first-time Step 1 pass rate of about 96.8%. The brochure further claimed: “Saint James is the first and only medical school to offer a USMLE Step 1 Pass Guarantee,” according to the FTC complaint.

The FTC said the USMLE rate is lower than touted and lower than reported by other U.S. and Canadian medical schools. “Since 2017, only 35% of Saint James students who have completed the necessary coursework to take the USMLE Step 1 exam passed the test.”

The school also misrepresented the residency match rate as “the same” as American medical schools, according to the complaint. For example, the school instructed telemarketers to tell consumers that the match rate for the school’s students was 85%-90%. The school stated on its website that the residency match rate for Saint James students was 83%. “In fact, the match rate for SJSM students is lower than touted and lower than that reported by U.S. medical schools. Since 2018, defendants’ average match rate has been 63%.”

The FTC also claims the school used illegal credit contracts when marketing financing for tuition and living expenses for students. “The financing contracts contained language attempting to waive consumers’ rights under federal law and omit legally mandated disclosures.”

Saint James’ tuition ranges from about $6,650 to $9,859 per trimester, depending on campus and course study, the complaint states. Between 2016 and 2020, about 1,300 students were enrolled each year in Saint James’ schools. Students who attended the schools between 2016 and 2022 are eligible for a refund under the settlement.

Saint James is required to notify consumers whose debts are being canceled through Delta Financial Solutions, Saint James’ financing partner. The debt will also be deleted from consumers’ credit reports.

“We have chosen to settle with the FTC over its allegations that disclosures on our website and in Delta’s loan agreements were insufficient,” Mr. Guha stated on the school website. “However, we have added additional language and clarifications any time the USMLE pass rate and placement rates are mentioned.”

He said he hopes the school will be “an industry leader for transparency and accountability” and that the school’s “efforts will lead to lasting change throughout the for-profit educational industry.”

Mr. Guha added that more than 600 of the school’s alumni are serving as doctors, including many “working to bridge the health equity gap in underserved areas in North America.”

The FTC has been cracking down on deceptive practices by for-profit institutions. In October, the FTC put 70 for-profit colleges on notice that it would investigate false promises the schools make about their graduates’ job prospects, expected earnings, and other educational outcomes and would levy significant financial penalties against violators. Saint James was not on that list, which included several of the largest for-profit universities in the nation, including Capella University, DeVry University, Strayer University, and Walden University.

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

Although it disputed the allegations, Saint James School of Medicine has settled a complaint with the Federal Trade Commission that the school used deceptive marketing tactics to lure students. The complaint referenced the school’s medical license exam test pass rate and residency matches along with violations of rules that protect consumers, including those dealing with credit contracts.

The school, based in the Caribbean with operations in Illinois, agreed to pay $1.2 million toward refunds and debt cancellation for students harmed by the marketing in the past 5 years.

“While we strongly disagree with the FTC’s approach to this matter, we did not want a lengthy legal process to distract from our mission of providing a quality medical education at an affordable cost,” Kaushik Guha, executive vice president of the parent of the school, Human Resources Development Services, said in a YouTube statement posted on the school’s website.

“Saint James lured students by lying about their chances of success,” Samuel Levine, director of the FTC’s Bureau of Consumer Protection, said in a press release. The settlement agreement was with HRDS, which bills itself as providing students from “non-traditional backgrounds the opportunity to pursue a medical degree and practice in the U.S. or Canada,” according to the school’s statement.

The complaint alleges that, since at least April 2018, the school, HRDS, and its operator Mr. Guha has lured students using “phony claims about the standardized test pass rate and students’ residency or job prospects. They lured consumers with false guarantees of student success at passing a critical medical school standardized test, the United States Medical Licensing Examination Step 1 Exam.”

For example, a brochure distributed at open houses claimed a first-time Step 1 pass rate of about 96.8%. The brochure further claimed: “Saint James is the first and only medical school to offer a USMLE Step 1 Pass Guarantee,” according to the FTC complaint.

The FTC said the USMLE rate is lower than touted and lower than reported by other U.S. and Canadian medical schools. “Since 2017, only 35% of Saint James students who have completed the necessary coursework to take the USMLE Step 1 exam passed the test.”

The school also misrepresented the residency match rate as “the same” as American medical schools, according to the complaint. For example, the school instructed telemarketers to tell consumers that the match rate for the school’s students was 85%-90%. The school stated on its website that the residency match rate for Saint James students was 83%. “In fact, the match rate for SJSM students is lower than touted and lower than that reported by U.S. medical schools. Since 2018, defendants’ average match rate has been 63%.”

The FTC also claims the school used illegal credit contracts when marketing financing for tuition and living expenses for students. “The financing contracts contained language attempting to waive consumers’ rights under federal law and omit legally mandated disclosures.”

Saint James’ tuition ranges from about $6,650 to $9,859 per trimester, depending on campus and course study, the complaint states. Between 2016 and 2020, about 1,300 students were enrolled each year in Saint James’ schools. Students who attended the schools between 2016 and 2022 are eligible for a refund under the settlement.

Saint James is required to notify consumers whose debts are being canceled through Delta Financial Solutions, Saint James’ financing partner. The debt will also be deleted from consumers’ credit reports.

“We have chosen to settle with the FTC over its allegations that disclosures on our website and in Delta’s loan agreements were insufficient,” Mr. Guha stated on the school website. “However, we have added additional language and clarifications any time the USMLE pass rate and placement rates are mentioned.”

He said he hopes the school will be “an industry leader for transparency and accountability” and that the school’s “efforts will lead to lasting change throughout the for-profit educational industry.”

Mr. Guha added that more than 600 of the school’s alumni are serving as doctors, including many “working to bridge the health equity gap in underserved areas in North America.”

The FTC has been cracking down on deceptive practices by for-profit institutions. In October, the FTC put 70 for-profit colleges on notice that it would investigate false promises the schools make about their graduates’ job prospects, expected earnings, and other educational outcomes and would levy significant financial penalties against violators. Saint James was not on that list, which included several of the largest for-profit universities in the nation, including Capella University, DeVry University, Strayer University, and Walden University.

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

Although it disputed the allegations, Saint James School of Medicine has settled a complaint with the Federal Trade Commission that the school used deceptive marketing tactics to lure students. The complaint referenced the school’s medical license exam test pass rate and residency matches along with violations of rules that protect consumers, including those dealing with credit contracts.

The school, based in the Caribbean with operations in Illinois, agreed to pay $1.2 million toward refunds and debt cancellation for students harmed by the marketing in the past 5 years.

“While we strongly disagree with the FTC’s approach to this matter, we did not want a lengthy legal process to distract from our mission of providing a quality medical education at an affordable cost,” Kaushik Guha, executive vice president of the parent of the school, Human Resources Development Services, said in a YouTube statement posted on the school’s website.

“Saint James lured students by lying about their chances of success,” Samuel Levine, director of the FTC’s Bureau of Consumer Protection, said in a press release. The settlement agreement was with HRDS, which bills itself as providing students from “non-traditional backgrounds the opportunity to pursue a medical degree and practice in the U.S. or Canada,” according to the school’s statement.

The complaint alleges that, since at least April 2018, the school, HRDS, and its operator Mr. Guha has lured students using “phony claims about the standardized test pass rate and students’ residency or job prospects. They lured consumers with false guarantees of student success at passing a critical medical school standardized test, the United States Medical Licensing Examination Step 1 Exam.”

For example, a brochure distributed at open houses claimed a first-time Step 1 pass rate of about 96.8%. The brochure further claimed: “Saint James is the first and only medical school to offer a USMLE Step 1 Pass Guarantee,” according to the FTC complaint.

The FTC said the USMLE rate is lower than touted and lower than reported by other U.S. and Canadian medical schools. “Since 2017, only 35% of Saint James students who have completed the necessary coursework to take the USMLE Step 1 exam passed the test.”

The school also misrepresented the residency match rate as “the same” as American medical schools, according to the complaint. For example, the school instructed telemarketers to tell consumers that the match rate for the school’s students was 85%-90%. The school stated on its website that the residency match rate for Saint James students was 83%. “In fact, the match rate for SJSM students is lower than touted and lower than that reported by U.S. medical schools. Since 2018, defendants’ average match rate has been 63%.”

The FTC also claims the school used illegal credit contracts when marketing financing for tuition and living expenses for students. “The financing contracts contained language attempting to waive consumers’ rights under federal law and omit legally mandated disclosures.”

Saint James’ tuition ranges from about $6,650 to $9,859 per trimester, depending on campus and course study, the complaint states. Between 2016 and 2020, about 1,300 students were enrolled each year in Saint James’ schools. Students who attended the schools between 2016 and 2022 are eligible for a refund under the settlement.

Saint James is required to notify consumers whose debts are being canceled through Delta Financial Solutions, Saint James’ financing partner. The debt will also be deleted from consumers’ credit reports.

“We have chosen to settle with the FTC over its allegations that disclosures on our website and in Delta’s loan agreements were insufficient,” Mr. Guha stated on the school website. “However, we have added additional language and clarifications any time the USMLE pass rate and placement rates are mentioned.”

He said he hopes the school will be “an industry leader for transparency and accountability” and that the school’s “efforts will lead to lasting change throughout the for-profit educational industry.”

Mr. Guha added that more than 600 of the school’s alumni are serving as doctors, including many “working to bridge the health equity gap in underserved areas in North America.”

The FTC has been cracking down on deceptive practices by for-profit institutions. In October, the FTC put 70 for-profit colleges on notice that it would investigate false promises the schools make about their graduates’ job prospects, expected earnings, and other educational outcomes and would levy significant financial penalties against violators. Saint James was not on that list, which included several of the largest for-profit universities in the nation, including Capella University, DeVry University, Strayer University, and Walden University.

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

A federal judge in Florida has struck down the Biden administration’s mandate that travelers on airlines, buses, trains, and other public transit wear masks.

The mandate, enacted in February 2021, is unconstitutional because Congress never granted the Centers for Disease Control and Prevention the power to create such a requirement, U.S. District Judge Kathryn Kimball Mizelle said in her order issued April 18.

“Congress addressed whether the CDC may enact preventative measures that condition the interstate travel of an entire population to CDC dictates. It may not,” the order says.

While the government argued that the definition of “sanitation” in federal law allows it to create travel restrictions like the use of masks, Judge Mizelle disagreed.

“A power to improve ‘sanitation’ would easily extend to requiring vaccinations against COVID-19, the seasonal flu, or other diseases. Or to mandatory social distancing, coughing-into-elbows, and daily multivitamins,” she wrote.

The Biden administration has extended the mask mandate several times since it was first announced. Most recently, the mandate was extended last week and was set to end May 3.

The rule has been alternately praised and criticized by airlines, pilots, and flight attendants. Lawsuits have been filed over the mandate, but Judge Mizelle ruled in favor of two people and the Health Freedom Defense Fund, who filed suit in July 2021.

It is not yet clear if the Biden administration will appeal the decision.

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

A federal judge in Florida has struck down the Biden administration’s mandate that travelers on airlines, buses, trains, and other public transit wear masks.

The mandate, enacted in February 2021, is unconstitutional because Congress never granted the Centers for Disease Control and Prevention the power to create such a requirement, U.S. District Judge Kathryn Kimball Mizelle said in her order issued April 18.

“Congress addressed whether the CDC may enact preventative measures that condition the interstate travel of an entire population to CDC dictates. It may not,” the order says.

While the government argued that the definition of “sanitation” in federal law allows it to create travel restrictions like the use of masks, Judge Mizelle disagreed.

“A power to improve ‘sanitation’ would easily extend to requiring vaccinations against COVID-19, the seasonal flu, or other diseases. Or to mandatory social distancing, coughing-into-elbows, and daily multivitamins,” she wrote.

The Biden administration has extended the mask mandate several times since it was first announced. Most recently, the mandate was extended last week and was set to end May 3.

The rule has been alternately praised and criticized by airlines, pilots, and flight attendants. Lawsuits have been filed over the mandate, but Judge Mizelle ruled in favor of two people and the Health Freedom Defense Fund, who filed suit in July 2021.

It is not yet clear if the Biden administration will appeal the decision.

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

A federal judge in Florida has struck down the Biden administration’s mandate that travelers on airlines, buses, trains, and other public transit wear masks.

The mandate, enacted in February 2021, is unconstitutional because Congress never granted the Centers for Disease Control and Prevention the power to create such a requirement, U.S. District Judge Kathryn Kimball Mizelle said in her order issued April 18.

“Congress addressed whether the CDC may enact preventative measures that condition the interstate travel of an entire population to CDC dictates. It may not,” the order says.

While the government argued that the definition of “sanitation” in federal law allows it to create travel restrictions like the use of masks, Judge Mizelle disagreed.

“A power to improve ‘sanitation’ would easily extend to requiring vaccinations against COVID-19, the seasonal flu, or other diseases. Or to mandatory social distancing, coughing-into-elbows, and daily multivitamins,” she wrote.

The Biden administration has extended the mask mandate several times since it was first announced. Most recently, the mandate was extended last week and was set to end May 3.

The rule has been alternately praised and criticized by airlines, pilots, and flight attendants. Lawsuits have been filed over the mandate, but Judge Mizelle ruled in favor of two people and the Health Freedom Defense Fund, who filed suit in July 2021.

It is not yet clear if the Biden administration will appeal the decision.

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

More than one in seven patients with breast cancer saw their financial status deteriorate within the first years after their diagnosis, a new study found. Factors like disease severity and treatment type didn’t seem to have an impact on financial status.

The findings, presented at the annual meeting of the American Association for Cancer Research, were unexpected. “We were surprised that we did not find that patients who received more aggressive therapies were more likely to experience worsening financial concerns,” said corresponding author and medical oncologist Kathryn J. Ruddy, MD, of the Mayo Clinici in Rochester, Minn.

The study was undertaken to understand the financial stress facing patients with breast cancer. The question was whether individual or disease factors, or both, were at play.

The study is based on results from the Mayo Clinic Breast Disease Registry, a prospective cohort of patient who were at Mayo Clinic Rochester. Participants answered questions about their finances at baseline and then again at annual follow-ups.

Researchers examined survey findings from 1,957 patients (mean age 58.5, 99.1% female, 95.4% White, 54.9% bachelor degree or higher) who answered questions at least twice from 2015-2020. The average time between diagnosis and the most recent follow-up was 25.6 months.

Of the 1,957 patients, 357 (18.2%) said their finances deteriorated as measured by a 1 point or higher decline on a 10-point scale.

There was no statistically significant link between deteriorating finances and age, race, employment status, stage of cancer at diagnosis, type of cancer, or treatment type. There was a slight link between deteriorating finances and reporting that they were in the category of “pay bills, no money for special things” near diagnosis.

Other research has suggested that breast cancer may not disrupt finances to a large extent, at least early on. Earlier in 2022, Stanford (Calif.) University researchers reported the results of a survey of 273 breast and gynecologic cancer patients who were surveyed about their finances at a mean of 3.4 years after diagnosis. While one-third said their cancer caused career changes, the study described overall financial toxicity as mild.

In regard to limitations, the subject population of the new study is overwhelmingly White, and the finances were self-reported by those who participated in the survey. Also, “because our participants were recruited at a tertiary medical center, there were relatively financially secure at baseline,” Dr. Ruddy said. “More financial hardship would be expected in a more financially diverse population.”

In an interview, Cathy Bradley, PhD, associate dean for research at the University of Colorado at Denver and deputy director of the University of Colorado Cancer Center, both in Aurora, praised the study as “an important start toward assessing financial burden in the clinic. Having more universal assessments in the clinic would remove stigma.”

She cautioned about interpreting a seemingly low number of patients whose financial situation worsened. “This was for a single site where there is a high rate of health insurance either through Medicare or Medicaid. There may be some selection bias as well given that Mayo may attract a wealthier patient population. Most women completed treatment and may not have been on long-term therapies.”

Moving forward, Dr. Ruddy said, “we hope to study cost of oncologic care in more geographically and financially diverse populations with breast cancer and other cancers.”

The study was funded by the Breast Cancer Research Foundation and National Cancer Institute. The study authors and Dr. Ruddy report no relevant disclosures.