This article is part of a series from Medscape on vaping.

Every day, Sonia Sharma, PA, meets people like Natalie H., who is trying to quit vaping.

Natalie, a member of the nicotine addiction support group at the University of California San Francisco’s Fontana Tobacco Treatment Center, switched from traditional cigarettes to vaping but found the electronic version just as addictive and eventually decided to quit using nicotine completely.

“I went from being an occasional cigarette smoker, a few a month, to a daily vaper,” said Natalie, who preferred not to give her last name to protect her privacy. “Vaping made my nicotine addiction worse, not better.”

“We have people tell us they vape before their feet hit the ground in the morning,” said Ms. Sharma, who coleads Natalie’s support group at UCSF. Ms. Sharma has met individuals who had smoked four to five cigarettes a day, switched to e-cigarettes to quit smoking, then vaped the equivalent of a pack a day. Others had switched to vapes to quit but ended up both vaping and smoking again. And others picked up vaping without ever smoking. They want to quit, she said, but are not sure how.

Researchers from the National Institutes of Health in 2020 reported that 5.6 million  adults in the United States vaped. A little over 57% of people said they started using e-cigarettes to quit smoking traditional cigarettes. Another study in 2021 based on survey data found that about 60% of e-cigarette users wanted to quit their vaping habit. 

Vaping has been marketed as a way to help people kick their smoking habit. Research is inconclusive on this claim. But unlike cessation tools like nicotine gums or lozenges, using vapes for cessation is uncharted territory. Vapers lack guidance for how to use the devices to quit, and they have even less direction on what to do if they develop an addiction to the vapes themselves.
 

A new addiction?

Monica Hanna, MPH, assistant director of the Nicotine and Tobacco Recovery Program at RWJBarnabas Health’s Institute for Prevention and Recovery in New Jersey, said she has witnessed a higher level of nicotine addiction in the vapers with whom she has worked.

“When someone takes a hit from a vaping device, it doesn’t generate the burn it would from traditional tobacco,” Ms. Hanna said. “This causes people to take a deeper pull, and when they take a deeper pull, they establish a higher level of nicotine dependence over time.” 

A 2019 study of nearly 900 people published in the New England Journal of Medicine found that smokers who used vapes for cessation were twice as likely to have quit smoking cigarettes as those who used other nicotine replacement therapy. However, 80% of people who switched to vaping were using e-cigarettes a year after they tried to quit smoking.

Given that potential for addiction, Nancy Rigotti, MD, director of Massachusetts General Hospital’s Tobacco Research and Treatment Center in Boston, said patients must use vapes “properly” for cessation. That means giving up smoking completely and quitting vapes as soon as patients are sure they will not go back to smoking tobacco.

“We are going to need to help these people to stop vaping,” said Dr. Rigotti, who is working with Achieve Life Sciences, a pharmaceutical company developing a prescription drug to treat nicotine addiction from vapes and cigarettes.

And many nicotine users who have tried vaping to quit smoking end up becoming dual users.

“It’s important to stress that health benefits [of switching to vaping] only occur if the switch to vapes is complete and permanent. So far, that appears difficult to do for most people who smoke, and in my anecdotal experience it has not worked,” said J. Taylor Hays, MD, the former medical director of Mayo Clinic’s Nicotine Dependence Center in Rochester, Minn.

Besides challenges in communicating the current evidence, no established method exists to help vapers quit, according to Nigar Nargis, PhD, senior scientific director of tobacco control research at the American Cancer Society. 

“There are some experimental methods like using social interventions, counseling, and some educational campaigns,” Dr. Nargis said. “[Little] progress has been done in terms of clinical interventions.”

Unlike cessation products such as gum or a nicotine patch, which have clear recommendations for duration of use, similar guidelines don’t exist for vapes, in part because the U.S. Food and Drug Administration hasn’t yet granted approval of vapes as cessation products.

Alex Clark, the CEO of Consumer Advocates for Smoke-free Alternatives Association, a nonprofit group that supports vaping, said people could vape for longer and still benefit from making the switch from traditional cigarettes.

“The most important thing is that people start replacing cigarettes with a smoke-free product and continue until they’ve completely switched,” said Mr. Clark, whose group accepts donations from the e-cigarette industry. “Following switching, people are encouraged to continue with the product for as long as they feel necessary.”

But 2013 guidelines from the FDA advised makers of nicotine-replacement therapies – including gums, patches, and lozenges – to include labeling that advises users to complete treatment. According to the agency, if a person feels like they “need to use [the NRT product] for a longer period to keep from smoking, talk to your health care provider.”

Dr. Hays, who is now an emeritus professor at the Mayo Clinic, said he would not recommend patients try vaping as a cessation device given the availability of more proven techniques such as patches and gums. If a patient insists, vaping could be considered under the medical guidance of a cessation professional. He also advised people purchase products only from large tobacco companies that are likely to have “reasonable quality control.” Hundreds of vaping devices are on the market, and they are not all equivalent, he said.

But when an e-cigarette user wants to quit vaping, guidance might boil down to using traditional tobacco cessation methods like gums and lozenges because few tools exist to help people with a vaping-specific addiction.

The long-term health outcomes of vaping are also unclear, and decades will pass before scientists are able to make conclusions, according to Thomas Eissenberg, PhD, codirector of Virginia Commonwealth University’s Center for the Study of Tobacco Products in Richmond.

“I don’t think anyone knows what the long-term effects of heated propylene glycol and vegetable glycerin and flavors intended as food ingredients are, especially when these compounds are inhaled hundreds of times a day, week after week, year after year,” Dr. Eissenberg said.

Dr. Rigotti reported that she receives no funding from the tobacco or e-cigarette industry. She is working with Achieve Life Sciences to develop a tool for vaping cessation. Dr. Eissenberg, Ms. Hanna, Dr. Hays, Dr. Nargis, and Ms. Sharma reported no funding from the tobacco or e-cigarette industry.

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

This article is part of a series from Medscape on vaping.

Every day, Sonia Sharma, PA, meets people like Natalie H., who is trying to quit vaping.

Natalie, a member of the nicotine addiction support group at the University of California San Francisco’s Fontana Tobacco Treatment Center, switched from traditional cigarettes to vaping but found the electronic version just as addictive and eventually decided to quit using nicotine completely.

“I went from being an occasional cigarette smoker, a few a month, to a daily vaper,” said Natalie, who preferred not to give her last name to protect her privacy. “Vaping made my nicotine addiction worse, not better.”

“We have people tell us they vape before their feet hit the ground in the morning,” said Ms. Sharma, who coleads Natalie’s support group at UCSF. Ms. Sharma has met individuals who had smoked four to five cigarettes a day, switched to e-cigarettes to quit smoking, then vaped the equivalent of a pack a day. Others had switched to vapes to quit but ended up both vaping and smoking again. And others picked up vaping without ever smoking. They want to quit, she said, but are not sure how.

Researchers from the National Institutes of Health in 2020 reported that 5.6 million  adults in the United States vaped. A little over 57% of people said they started using e-cigarettes to quit smoking traditional cigarettes. Another study in 2021 based on survey data found that about 60% of e-cigarette users wanted to quit their vaping habit. 

Vaping has been marketed as a way to help people kick their smoking habit. Research is inconclusive on this claim. But unlike cessation tools like nicotine gums or lozenges, using vapes for cessation is uncharted territory. Vapers lack guidance for how to use the devices to quit, and they have even less direction on what to do if they develop an addiction to the vapes themselves.
 

A new addiction?

Monica Hanna, MPH, assistant director of the Nicotine and Tobacco Recovery Program at RWJBarnabas Health’s Institute for Prevention and Recovery in New Jersey, said she has witnessed a higher level of nicotine addiction in the vapers with whom she has worked.

“When someone takes a hit from a vaping device, it doesn’t generate the burn it would from traditional tobacco,” Ms. Hanna said. “This causes people to take a deeper pull, and when they take a deeper pull, they establish a higher level of nicotine dependence over time.” 

A 2019 study of nearly 900 people published in the New England Journal of Medicine found that smokers who used vapes for cessation were twice as likely to have quit smoking cigarettes as those who used other nicotine replacement therapy. However, 80% of people who switched to vaping were using e-cigarettes a year after they tried to quit smoking.

Given that potential for addiction, Nancy Rigotti, MD, director of Massachusetts General Hospital’s Tobacco Research and Treatment Center in Boston, said patients must use vapes “properly” for cessation. That means giving up smoking completely and quitting vapes as soon as patients are sure they will not go back to smoking tobacco.

“We are going to need to help these people to stop vaping,” said Dr. Rigotti, who is working with Achieve Life Sciences, a pharmaceutical company developing a prescription drug to treat nicotine addiction from vapes and cigarettes.

And many nicotine users who have tried vaping to quit smoking end up becoming dual users.

“It’s important to stress that health benefits [of switching to vaping] only occur if the switch to vapes is complete and permanent. So far, that appears difficult to do for most people who smoke, and in my anecdotal experience it has not worked,” said J. Taylor Hays, MD, the former medical director of Mayo Clinic’s Nicotine Dependence Center in Rochester, Minn.

Besides challenges in communicating the current evidence, no established method exists to help vapers quit, according to Nigar Nargis, PhD, senior scientific director of tobacco control research at the American Cancer Society. 

“There are some experimental methods like using social interventions, counseling, and some educational campaigns,” Dr. Nargis said. “[Little] progress has been done in terms of clinical interventions.”

Unlike cessation products such as gum or a nicotine patch, which have clear recommendations for duration of use, similar guidelines don’t exist for vapes, in part because the U.S. Food and Drug Administration hasn’t yet granted approval of vapes as cessation products.

Alex Clark, the CEO of Consumer Advocates for Smoke-free Alternatives Association, a nonprofit group that supports vaping, said people could vape for longer and still benefit from making the switch from traditional cigarettes.

“The most important thing is that people start replacing cigarettes with a smoke-free product and continue until they’ve completely switched,” said Mr. Clark, whose group accepts donations from the e-cigarette industry. “Following switching, people are encouraged to continue with the product for as long as they feel necessary.”

But 2013 guidelines from the FDA advised makers of nicotine-replacement therapies – including gums, patches, and lozenges – to include labeling that advises users to complete treatment. According to the agency, if a person feels like they “need to use [the NRT product] for a longer period to keep from smoking, talk to your health care provider.”

Dr. Hays, who is now an emeritus professor at the Mayo Clinic, said he would not recommend patients try vaping as a cessation device given the availability of more proven techniques such as patches and gums. If a patient insists, vaping could be considered under the medical guidance of a cessation professional. He also advised people purchase products only from large tobacco companies that are likely to have “reasonable quality control.” Hundreds of vaping devices are on the market, and they are not all equivalent, he said.

But when an e-cigarette user wants to quit vaping, guidance might boil down to using traditional tobacco cessation methods like gums and lozenges because few tools exist to help people with a vaping-specific addiction.

The long-term health outcomes of vaping are also unclear, and decades will pass before scientists are able to make conclusions, according to Thomas Eissenberg, PhD, codirector of Virginia Commonwealth University’s Center for the Study of Tobacco Products in Richmond.

“I don’t think anyone knows what the long-term effects of heated propylene glycol and vegetable glycerin and flavors intended as food ingredients are, especially when these compounds are inhaled hundreds of times a day, week after week, year after year,” Dr. Eissenberg said.

Dr. Rigotti reported that she receives no funding from the tobacco or e-cigarette industry. She is working with Achieve Life Sciences to develop a tool for vaping cessation. Dr. Eissenberg, Ms. Hanna, Dr. Hays, Dr. Nargis, and Ms. Sharma reported no funding from the tobacco or e-cigarette industry.

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

This article is part of a series from Medscape on vaping.

Every day, Sonia Sharma, PA, meets people like Natalie H., who is trying to quit vaping.

Natalie, a member of the nicotine addiction support group at the University of California San Francisco’s Fontana Tobacco Treatment Center, switched from traditional cigarettes to vaping but found the electronic version just as addictive and eventually decided to quit using nicotine completely.

“I went from being an occasional cigarette smoker, a few a month, to a daily vaper,” said Natalie, who preferred not to give her last name to protect her privacy. “Vaping made my nicotine addiction worse, not better.”

“We have people tell us they vape before their feet hit the ground in the morning,” said Ms. Sharma, who coleads Natalie’s support group at UCSF. Ms. Sharma has met individuals who had smoked four to five cigarettes a day, switched to e-cigarettes to quit smoking, then vaped the equivalent of a pack a day. Others had switched to vapes to quit but ended up both vaping and smoking again. And others picked up vaping without ever smoking. They want to quit, she said, but are not sure how.

Researchers from the National Institutes of Health in 2020 reported that 5.6 million  adults in the United States vaped. A little over 57% of people said they started using e-cigarettes to quit smoking traditional cigarettes. Another study in 2021 based on survey data found that about 60% of e-cigarette users wanted to quit their vaping habit. 

Vaping has been marketed as a way to help people kick their smoking habit. Research is inconclusive on this claim. But unlike cessation tools like nicotine gums or lozenges, using vapes for cessation is uncharted territory. Vapers lack guidance for how to use the devices to quit, and they have even less direction on what to do if they develop an addiction to the vapes themselves.
 

A new addiction?

Monica Hanna, MPH, assistant director of the Nicotine and Tobacco Recovery Program at RWJBarnabas Health’s Institute for Prevention and Recovery in New Jersey, said she has witnessed a higher level of nicotine addiction in the vapers with whom she has worked.

“When someone takes a hit from a vaping device, it doesn’t generate the burn it would from traditional tobacco,” Ms. Hanna said. “This causes people to take a deeper pull, and when they take a deeper pull, they establish a higher level of nicotine dependence over time.” 

A 2019 study of nearly 900 people published in the New England Journal of Medicine found that smokers who used vapes for cessation were twice as likely to have quit smoking cigarettes as those who used other nicotine replacement therapy. However, 80% of people who switched to vaping were using e-cigarettes a year after they tried to quit smoking.

Given that potential for addiction, Nancy Rigotti, MD, director of Massachusetts General Hospital’s Tobacco Research and Treatment Center in Boston, said patients must use vapes “properly” for cessation. That means giving up smoking completely and quitting vapes as soon as patients are sure they will not go back to smoking tobacco.

“We are going to need to help these people to stop vaping,” said Dr. Rigotti, who is working with Achieve Life Sciences, a pharmaceutical company developing a prescription drug to treat nicotine addiction from vapes and cigarettes.

And many nicotine users who have tried vaping to quit smoking end up becoming dual users.

“It’s important to stress that health benefits [of switching to vaping] only occur if the switch to vapes is complete and permanent. So far, that appears difficult to do for most people who smoke, and in my anecdotal experience it has not worked,” said J. Taylor Hays, MD, the former medical director of Mayo Clinic’s Nicotine Dependence Center in Rochester, Minn.

Besides challenges in communicating the current evidence, no established method exists to help vapers quit, according to Nigar Nargis, PhD, senior scientific director of tobacco control research at the American Cancer Society. 

“There are some experimental methods like using social interventions, counseling, and some educational campaigns,” Dr. Nargis said. “[Little] progress has been done in terms of clinical interventions.”

Unlike cessation products such as gum or a nicotine patch, which have clear recommendations for duration of use, similar guidelines don’t exist for vapes, in part because the U.S. Food and Drug Administration hasn’t yet granted approval of vapes as cessation products.

Alex Clark, the CEO of Consumer Advocates for Smoke-free Alternatives Association, a nonprofit group that supports vaping, said people could vape for longer and still benefit from making the switch from traditional cigarettes.

“The most important thing is that people start replacing cigarettes with a smoke-free product and continue until they’ve completely switched,” said Mr. Clark, whose group accepts donations from the e-cigarette industry. “Following switching, people are encouraged to continue with the product for as long as they feel necessary.”

But 2013 guidelines from the FDA advised makers of nicotine-replacement therapies – including gums, patches, and lozenges – to include labeling that advises users to complete treatment. According to the agency, if a person feels like they “need to use [the NRT product] for a longer period to keep from smoking, talk to your health care provider.”

Dr. Hays, who is now an emeritus professor at the Mayo Clinic, said he would not recommend patients try vaping as a cessation device given the availability of more proven techniques such as patches and gums. If a patient insists, vaping could be considered under the medical guidance of a cessation professional. He also advised people purchase products only from large tobacco companies that are likely to have “reasonable quality control.” Hundreds of vaping devices are on the market, and they are not all equivalent, he said.

But when an e-cigarette user wants to quit vaping, guidance might boil down to using traditional tobacco cessation methods like gums and lozenges because few tools exist to help people with a vaping-specific addiction.

The long-term health outcomes of vaping are also unclear, and decades will pass before scientists are able to make conclusions, according to Thomas Eissenberg, PhD, codirector of Virginia Commonwealth University’s Center for the Study of Tobacco Products in Richmond.

“I don’t think anyone knows what the long-term effects of heated propylene glycol and vegetable glycerin and flavors intended as food ingredients are, especially when these compounds are inhaled hundreds of times a day, week after week, year after year,” Dr. Eissenberg said.

Dr. Rigotti reported that she receives no funding from the tobacco or e-cigarette industry. She is working with Achieve Life Sciences to develop a tool for vaping cessation. Dr. Eissenberg, Ms. Hanna, Dr. Hays, Dr. Nargis, and Ms. Sharma reported no funding from the tobacco or e-cigarette industry.

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

Women harboring BRCA1/2 gene mutations are at high risk for breast cancer, and thus it’s recommended they undergo annual breast MRI screening in addition to mammogram screening.
 

However, some women are finding that their insurer is refusing to cover the cost of the MRI.

A new study exploring this issue was presented at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer.

“Despite guidelines supporting annual breast MRI for screening in patients with gBRCA1/2, insurance denials were present in 11% of patients,” said lead author Sushmita Gordhandas, MD, a gynecologic oncology fellow at Memorial Sloan Kettering Cancer Center, New York. “In a high-resource setting, up to 14% of patients who were denied coverage did not undergo recommended MRI screening.”

She also pointed out that the rate of denials was rising. “Compared to 2020, there were significantly more denials, and denials on appeal, in 2021,” Dr. Gordhandas said. “This suggested worsening barriers and added burden on health care systems.”

The addition of MRI to mammography is a standard recommendation for women with BRCA mutations, she pointed out, as it has been shown improve detection of early disease and decrease interval cancer development.

An expert not involved in the study noted that the recommendation for annual MRI screening in women at high risk for breast cancer is “substantiated by many publications, including multiple prospective clinical trials.”

Linda Moy, MD, a radiologist at NYU Langone’s Perlmutter Cancer Center and professor of radiology at NYU Grossman School of Medicine, both in New York, noted that the American Cancer Society’s Guidelines for screening breast MRI recommends annual breast MRI in women with a lifetime risk of greater than 20% – which includes women who are BRCA carriers – and recommends the screening begins at age 30.

“The lifetime breast cancer risk is 72% among BRCA1 and 69% among BRCA2 carriers,” she said, adding that the “American College of Radiology also recommends for BRCA carriers to undergo annual screening MRI at age 30.”

The National Comprehensive Cancer Network recommends that women at high risk for breast cancer undergo a mammogram and breast MRI every year starting at age 25 to 40, depending on the type of gene mutation, noted Dr. Gordhandas. “These guidelines are consistent with those from American College of Obstetricians and Gynecologists, the American Cancer Society, and the American College of Radiology.”
 

Denials increased over time

For the study, Dr. Gordhandas and colleagues looked at the frequency of insurance denials for indicated breast MRI screening in women with germline BRCA1/2 pathogenic variants, and also looked at recent trends in denials over time.

The cohort comprised 682 women with BRCA1/2 gene mutations who were followed in a specialized high-risk breast cancer clinic, and who had breast MRIs ordered from 2020 to 2021. They were then cross-referenced with a database of insurance denials. Radiology records were also accessed to determine if screening breast MRIs had been performed in 2020 and 2021, and rates of MRI denials and results after appeals were determined. The rates between the 2 years were then compared.

The team found that overall, 73 women (11%) had an MRI denied. The median age of women who received a denial was 38 years, whereas those who had it approved was 44 years. “Patients with denials were significantly younger and more likely to be in the Medicaid population,” said Dr. Gordhandas.

In 2020, 29 breast MRIs (5%) were denied, and on appeal, 8 (28%) were denied and 21 (72%) approved. The number of denials rose in 2021 but approvals remained the same; 45 breast MRIs were denied (8%); on appeal, 23 (51%) were denied, and 22 (49%) approved.

Thus, noted the authors, there were significantly more denials in 2021 as compared with 2020 (P = .044), and the denials in 2021 denials were statistically more likely to be denied on appeal (P = .045).

Among the women whose coverage was denied, four (14%) in 2020 and five (11%) in 2021 did not have an MRI screening performed. And within this group, 17 women (2.5%) received a diagnosis of cancer; 12 (1.8%) had invasive carcinoma, and 5 (0.7%) had ductal carcinoma in situ (DCIS). One patient with DCIS had an MRI denial prior to receiving her diagnosis.

“The top reasons given for denials were that they were outside the approved time frame, authorization on file for a similar study, and that the clinician failed to show medical necessity,” she explained.

Additional data are needed to establish a trend. “We are working to increase the approval time frame, which is currently 45 days, and provide resources for the patient to deal with denials,” Dr. Gordhandas added. “We also have to advocate for updates to [U.S. Preventive Services Task Force] screening recommendations in high-risk patients.”

Dr. Gordhandas reported no relevant financial relationships.

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

Women harboring BRCA1/2 gene mutations are at high risk for breast cancer, and thus it’s recommended they undergo annual breast MRI screening in addition to mammogram screening.
 

However, some women are finding that their insurer is refusing to cover the cost of the MRI.

A new study exploring this issue was presented at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer.

“Despite guidelines supporting annual breast MRI for screening in patients with gBRCA1/2, insurance denials were present in 11% of patients,” said lead author Sushmita Gordhandas, MD, a gynecologic oncology fellow at Memorial Sloan Kettering Cancer Center, New York. “In a high-resource setting, up to 14% of patients who were denied coverage did not undergo recommended MRI screening.”

She also pointed out that the rate of denials was rising. “Compared to 2020, there were significantly more denials, and denials on appeal, in 2021,” Dr. Gordhandas said. “This suggested worsening barriers and added burden on health care systems.”

The addition of MRI to mammography is a standard recommendation for women with BRCA mutations, she pointed out, as it has been shown improve detection of early disease and decrease interval cancer development.

An expert not involved in the study noted that the recommendation for annual MRI screening in women at high risk for breast cancer is “substantiated by many publications, including multiple prospective clinical trials.”

Linda Moy, MD, a radiologist at NYU Langone’s Perlmutter Cancer Center and professor of radiology at NYU Grossman School of Medicine, both in New York, noted that the American Cancer Society’s Guidelines for screening breast MRI recommends annual breast MRI in women with a lifetime risk of greater than 20% – which includes women who are BRCA carriers – and recommends the screening begins at age 30.

“The lifetime breast cancer risk is 72% among BRCA1 and 69% among BRCA2 carriers,” she said, adding that the “American College of Radiology also recommends for BRCA carriers to undergo annual screening MRI at age 30.”

The National Comprehensive Cancer Network recommends that women at high risk for breast cancer undergo a mammogram and breast MRI every year starting at age 25 to 40, depending on the type of gene mutation, noted Dr. Gordhandas. “These guidelines are consistent with those from American College of Obstetricians and Gynecologists, the American Cancer Society, and the American College of Radiology.”
 

Denials increased over time

For the study, Dr. Gordhandas and colleagues looked at the frequency of insurance denials for indicated breast MRI screening in women with germline BRCA1/2 pathogenic variants, and also looked at recent trends in denials over time.

The cohort comprised 682 women with BRCA1/2 gene mutations who were followed in a specialized high-risk breast cancer clinic, and who had breast MRIs ordered from 2020 to 2021. They were then cross-referenced with a database of insurance denials. Radiology records were also accessed to determine if screening breast MRIs had been performed in 2020 and 2021, and rates of MRI denials and results after appeals were determined. The rates between the 2 years were then compared.

The team found that overall, 73 women (11%) had an MRI denied. The median age of women who received a denial was 38 years, whereas those who had it approved was 44 years. “Patients with denials were significantly younger and more likely to be in the Medicaid population,” said Dr. Gordhandas.

In 2020, 29 breast MRIs (5%) were denied, and on appeal, 8 (28%) were denied and 21 (72%) approved. The number of denials rose in 2021 but approvals remained the same; 45 breast MRIs were denied (8%); on appeal, 23 (51%) were denied, and 22 (49%) approved.

Thus, noted the authors, there were significantly more denials in 2021 as compared with 2020 (P = .044), and the denials in 2021 denials were statistically more likely to be denied on appeal (P = .045).

Among the women whose coverage was denied, four (14%) in 2020 and five (11%) in 2021 did not have an MRI screening performed. And within this group, 17 women (2.5%) received a diagnosis of cancer; 12 (1.8%) had invasive carcinoma, and 5 (0.7%) had ductal carcinoma in situ (DCIS). One patient with DCIS had an MRI denial prior to receiving her diagnosis.

“The top reasons given for denials were that they were outside the approved time frame, authorization on file for a similar study, and that the clinician failed to show medical necessity,” she explained.

Additional data are needed to establish a trend. “We are working to increase the approval time frame, which is currently 45 days, and provide resources for the patient to deal with denials,” Dr. Gordhandas added. “We also have to advocate for updates to [U.S. Preventive Services Task Force] screening recommendations in high-risk patients.”

Dr. Gordhandas reported no relevant financial relationships.

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

Women harboring BRCA1/2 gene mutations are at high risk for breast cancer, and thus it’s recommended they undergo annual breast MRI screening in addition to mammogram screening.
 

However, some women are finding that their insurer is refusing to cover the cost of the MRI.

A new study exploring this issue was presented at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer.

“Despite guidelines supporting annual breast MRI for screening in patients with gBRCA1/2, insurance denials were present in 11% of patients,” said lead author Sushmita Gordhandas, MD, a gynecologic oncology fellow at Memorial Sloan Kettering Cancer Center, New York. “In a high-resource setting, up to 14% of patients who were denied coverage did not undergo recommended MRI screening.”

She also pointed out that the rate of denials was rising. “Compared to 2020, there were significantly more denials, and denials on appeal, in 2021,” Dr. Gordhandas said. “This suggested worsening barriers and added burden on health care systems.”

The addition of MRI to mammography is a standard recommendation for women with BRCA mutations, she pointed out, as it has been shown improve detection of early disease and decrease interval cancer development.

An expert not involved in the study noted that the recommendation for annual MRI screening in women at high risk for breast cancer is “substantiated by many publications, including multiple prospective clinical trials.”

Linda Moy, MD, a radiologist at NYU Langone’s Perlmutter Cancer Center and professor of radiology at NYU Grossman School of Medicine, both in New York, noted that the American Cancer Society’s Guidelines for screening breast MRI recommends annual breast MRI in women with a lifetime risk of greater than 20% – which includes women who are BRCA carriers – and recommends the screening begins at age 30.

“The lifetime breast cancer risk is 72% among BRCA1 and 69% among BRCA2 carriers,” she said, adding that the “American College of Radiology also recommends for BRCA carriers to undergo annual screening MRI at age 30.”

The National Comprehensive Cancer Network recommends that women at high risk for breast cancer undergo a mammogram and breast MRI every year starting at age 25 to 40, depending on the type of gene mutation, noted Dr. Gordhandas. “These guidelines are consistent with those from American College of Obstetricians and Gynecologists, the American Cancer Society, and the American College of Radiology.”
 

Denials increased over time

For the study, Dr. Gordhandas and colleagues looked at the frequency of insurance denials for indicated breast MRI screening in women with germline BRCA1/2 pathogenic variants, and also looked at recent trends in denials over time.

The cohort comprised 682 women with BRCA1/2 gene mutations who were followed in a specialized high-risk breast cancer clinic, and who had breast MRIs ordered from 2020 to 2021. They were then cross-referenced with a database of insurance denials. Radiology records were also accessed to determine if screening breast MRIs had been performed in 2020 and 2021, and rates of MRI denials and results after appeals were determined. The rates between the 2 years were then compared.

The team found that overall, 73 women (11%) had an MRI denied. The median age of women who received a denial was 38 years, whereas those who had it approved was 44 years. “Patients with denials were significantly younger and more likely to be in the Medicaid population,” said Dr. Gordhandas.

In 2020, 29 breast MRIs (5%) were denied, and on appeal, 8 (28%) were denied and 21 (72%) approved. The number of denials rose in 2021 but approvals remained the same; 45 breast MRIs were denied (8%); on appeal, 23 (51%) were denied, and 22 (49%) approved.

Thus, noted the authors, there were significantly more denials in 2021 as compared with 2020 (P = .044), and the denials in 2021 denials were statistically more likely to be denied on appeal (P = .045).

Among the women whose coverage was denied, four (14%) in 2020 and five (11%) in 2021 did not have an MRI screening performed. And within this group, 17 women (2.5%) received a diagnosis of cancer; 12 (1.8%) had invasive carcinoma, and 5 (0.7%) had ductal carcinoma in situ (DCIS). One patient with DCIS had an MRI denial prior to receiving her diagnosis.

“The top reasons given for denials were that they were outside the approved time frame, authorization on file for a similar study, and that the clinician failed to show medical necessity,” she explained.

Additional data are needed to establish a trend. “We are working to increase the approval time frame, which is currently 45 days, and provide resources for the patient to deal with denials,” Dr. Gordhandas added. “We also have to advocate for updates to [U.S. Preventive Services Task Force] screening recommendations in high-risk patients.”

Dr. Gordhandas reported no relevant financial relationships.

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

Jake Warn calls vaping “a toxic artificial love.”

Jake, of Winslow, Maine, was 16 years old when he began vaping. Unlike cigarettes, vaping can be odorless, and its smoke leaves no trace, which allowed him and his friends to use the devices in school bathrooms without fear of being caught.

He would use an entire cartridge containing the vape liquid, the equivalent of smoking one pack of tobacco cigarettes, within 1 school day. By the fall semester of his first year in college, Jake said his use had increased even more.

“It got pricey, so that’s when I really started to notice” the extent of his dependency, he said recently.

Vaping rates among teenagers in Maine doubled from 15.3% to 28.7% between 2017 and 2019, while Jake was in high school. In 2021, 11% of high schoolers across the nation said they regularly smoked e-cigarettes, and an estimated 28% have ever tried the devices, according to the Centers for Disease Control and Prevention.

The Food and Drug Administration classifies e-cigarettes as a tobacco product because many contain nicotine, which comes from tobacco. Like Jake, the habit is likely to carry into adulthood for many who start in their teenage years, experts say.

Electronic nicotine delivery systems (ENDS) such as vapes have been touted by their manufacturers and by some in the medical field as a healthier alternative to cigarettes and as a method to help smokers give up the habit.

But, that’s not how Jake – who had never used combustible cigarettes – picked up vaping, or how he sold the idea to his mother.

“It’s all organic and natural flavoring, it’s just flavored water,” Mary Lou Warn recalled her son saying to her. She researched the health effects of vaping but didn’t find much online. “I knew they were dangerous because you don’t put anything in your lungs that isn’t fresh air.”

A determined athlete in high school, Jake found that his asthma worsened as he transitioned to college, especially when he ran a track meet or during a soccer game.

Mrs. Warn noticed changes off the field, too.

“He was coughing constantly, he wasn’t sleeping well, he wasn’t eating well,” she said. “I knew the addiction was taking over.”

Vaping irritated Jake’s throat, and he would get nosebleeds that he couldn’t stop, she added.

Since Mrs. Warn first looked into the effects of e-cigarettes on respiratory health back in 2017, many studies have been conducted of the short-term health outcomes for first-time smokers who never used combustible tobacco products. Studies suggest that vaping may worsen bronchitis and asthma, raise blood pressure, interfere with brain development in young users, suppress the immune system, and increase the risk of developing a chronic lung disease (Am J Prev Med. 2020 Feb;58[2]:182-90). Studies of mice and cell cultures have found that the vapor or extracts from vapes damage the chemical structure of DNA.

Still, the limited number of long-term human studies has made it hard to know what the health outcomes of e-cigarette users will be in the future. Conclusive studies linking commercial cigarette use to deaths from heart disease and cancer didn’t emerge until the mid-1950s, decades after manufacturers began mass production and marketing in the early 20th century.

Years could pass before researchers gain a clearer understanding of the health implications of long-term e-cigarette use, according to Nigar Nargis, PhD, senior scientific director of tobacco control research at the American Cancer Society.

“There hasn’t been any such study to establish the direct link from ENDS to cancer, but it is understood that it [vaping] may promote the development of cancer and lung damage and inflammation,” Dr. Nargis said.

For decades, advocates built awareness of the harms of tobacco use, which led to a sharp decline in tobacco-related illnesses such as lung cancer. But Hilary Schneider, Maine’s director of government relations for the ACS Cancer Action Network, said she fears the uptick in the use of vapes – especially among those who never smoked or those who use both combustible cigarettes and e-cigarettes – may reverse declines in the rates of smoking-relating diseases.

Multiple studies suggest that inhaling chemicals found in e-cigarettes – including nicotine-carrying aerosols – can damage arteries and inflame and injure the lungs.

Vapes “basically have created a pediatric tobacco-use epidemic,” Ms. Schneider said. “What we’re seeing is unprecedented tobacco use rates, higher rates than we’ve seen in decades.”

One reason many young people start vaping is the attraction to flavors, which range from classic menthol to fruits and sweets. A handful of states have enacted bans or restrictions on the sale of flavored vapes.

“It’s new, and it’s just been marketed in a way that we’re really fighting the false narrative put out there by makers of these products that are trying to make them appealing to kids,” said Rachel Boykan, MD, clinical professor of pediatrics and attending physician at Stony Brook (N.Y.) Children’s Hospital.

The flavor Red Bull, in particular, hooked Jake. And though he wasn’t aware of it at the time, nicotine packed into the pods may have kept him from quitting: The average nicotine concentration in e-cigarettes more than doubled from 2013 to 2018, according to a study by the Truth Initiative and the CDC.

The immediate risks of nicotine on the developing brain are well documented. Studies suggest that nicotine – which is found in ENDS products – may affect adolescents’ ability to learn, remember, and maintain attention.

But many adolescents and young adults who use e-cigarettes say that vaping helps alleviate anxiety and keep them attentive, which adds to the complexity of their dependency, according to Dr. Boykan.

Nicotine “actually interrupts neural circuits, that it can be associated with more anxiety, depression, attention to learning, and susceptibility to other addictive substances,” she said. “That is enough to make it very scary.”

Jake also said a social environment in which so many of his friends vaped also made it difficult for him to quit.

“You’re hanging out with your friends at night, and all of them are using it, and you’re trying not to,” he said.

Jake eventually took a semester off from college for an unrelated surgery. He moved home, away from his vaping classmates. He eventually transferred to a different college and lived at home, where no one vaped and where he wasn’t allowed to smoke in the house, he said.

“He came home and we took him to a doctor, and they didn’t know quite how to handle kids and addiction to e-cigarettes,” Mrs. Warn said.

Not fully understanding the long-term health implications of e-cigarette use has precluded many clinicians from offering clear messaging on the risk of vaping to current and potential users.

“It’s taken pediatricians time to ask the right questions and recognize nicotine addiction” from vaping, said Dr. Boykan, who serves as chair of the Section on Nicotine and Tobacco Prevention and Treatment of the American Academy of Pediatrics. “It’s just hit us so fast.”

But once pediatricians do identify a nicotine dependency, it can be difficult to treat, Dr. Boykan said. Many pediatricians now recognize that e-cigarette addiction may occur in children as early as middle school.

“We don’t have a lot of evidence-based treatments for kids to recommend,” Dr. Boykan said.
 

Will vaping be a ‘phase?’

Aware of his vaping dependency and the possible risks to his long-term health, Jake, now 23, said he’s lessened his use, compared with his college days, but still struggles to kick the habit for good.

“I’d like to not be able to use all the time, not to feel the urge,” Jake said. “But I think over time it’ll just kind of phase out.”

But his mother said quitting may not be that simple.

“This will be a lifelong journey,” she said. “When I think of who he is, addiction is something he will always have. It’s a part of him now.”

Dr. Boykan, Ms. Schneider, and Dr. Nardis reported no relevant financial disclosures.

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

Jake Warn calls vaping “a toxic artificial love.”

Jake, of Winslow, Maine, was 16 years old when he began vaping. Unlike cigarettes, vaping can be odorless, and its smoke leaves no trace, which allowed him and his friends to use the devices in school bathrooms without fear of being caught.

He would use an entire cartridge containing the vape liquid, the equivalent of smoking one pack of tobacco cigarettes, within 1 school day. By the fall semester of his first year in college, Jake said his use had increased even more.

“It got pricey, so that’s when I really started to notice” the extent of his dependency, he said recently.

Vaping rates among teenagers in Maine doubled from 15.3% to 28.7% between 2017 and 2019, while Jake was in high school. In 2021, 11% of high schoolers across the nation said they regularly smoked e-cigarettes, and an estimated 28% have ever tried the devices, according to the Centers for Disease Control and Prevention.

The Food and Drug Administration classifies e-cigarettes as a tobacco product because many contain nicotine, which comes from tobacco. Like Jake, the habit is likely to carry into adulthood for many who start in their teenage years, experts say.

Electronic nicotine delivery systems (ENDS) such as vapes have been touted by their manufacturers and by some in the medical field as a healthier alternative to cigarettes and as a method to help smokers give up the habit.

But, that’s not how Jake – who had never used combustible cigarettes – picked up vaping, or how he sold the idea to his mother.

“It’s all organic and natural flavoring, it’s just flavored water,” Mary Lou Warn recalled her son saying to her. She researched the health effects of vaping but didn’t find much online. “I knew they were dangerous because you don’t put anything in your lungs that isn’t fresh air.”

A determined athlete in high school, Jake found that his asthma worsened as he transitioned to college, especially when he ran a track meet or during a soccer game.

Mrs. Warn noticed changes off the field, too.

“He was coughing constantly, he wasn’t sleeping well, he wasn’t eating well,” she said. “I knew the addiction was taking over.”

Vaping irritated Jake’s throat, and he would get nosebleeds that he couldn’t stop, she added.

Since Mrs. Warn first looked into the effects of e-cigarettes on respiratory health back in 2017, many studies have been conducted of the short-term health outcomes for first-time smokers who never used combustible tobacco products. Studies suggest that vaping may worsen bronchitis and asthma, raise blood pressure, interfere with brain development in young users, suppress the immune system, and increase the risk of developing a chronic lung disease (Am J Prev Med. 2020 Feb;58[2]:182-90). Studies of mice and cell cultures have found that the vapor or extracts from vapes damage the chemical structure of DNA.

Still, the limited number of long-term human studies has made it hard to know what the health outcomes of e-cigarette users will be in the future. Conclusive studies linking commercial cigarette use to deaths from heart disease and cancer didn’t emerge until the mid-1950s, decades after manufacturers began mass production and marketing in the early 20th century.

Years could pass before researchers gain a clearer understanding of the health implications of long-term e-cigarette use, according to Nigar Nargis, PhD, senior scientific director of tobacco control research at the American Cancer Society.

“There hasn’t been any such study to establish the direct link from ENDS to cancer, but it is understood that it [vaping] may promote the development of cancer and lung damage and inflammation,” Dr. Nargis said.

For decades, advocates built awareness of the harms of tobacco use, which led to a sharp decline in tobacco-related illnesses such as lung cancer. But Hilary Schneider, Maine’s director of government relations for the ACS Cancer Action Network, said she fears the uptick in the use of vapes – especially among those who never smoked or those who use both combustible cigarettes and e-cigarettes – may reverse declines in the rates of smoking-relating diseases.

Multiple studies suggest that inhaling chemicals found in e-cigarettes – including nicotine-carrying aerosols – can damage arteries and inflame and injure the lungs.

Vapes “basically have created a pediatric tobacco-use epidemic,” Ms. Schneider said. “What we’re seeing is unprecedented tobacco use rates, higher rates than we’ve seen in decades.”

One reason many young people start vaping is the attraction to flavors, which range from classic menthol to fruits and sweets. A handful of states have enacted bans or restrictions on the sale of flavored vapes.

“It’s new, and it’s just been marketed in a way that we’re really fighting the false narrative put out there by makers of these products that are trying to make them appealing to kids,” said Rachel Boykan, MD, clinical professor of pediatrics and attending physician at Stony Brook (N.Y.) Children’s Hospital.

The flavor Red Bull, in particular, hooked Jake. And though he wasn’t aware of it at the time, nicotine packed into the pods may have kept him from quitting: The average nicotine concentration in e-cigarettes more than doubled from 2013 to 2018, according to a study by the Truth Initiative and the CDC.

The immediate risks of nicotine on the developing brain are well documented. Studies suggest that nicotine – which is found in ENDS products – may affect adolescents’ ability to learn, remember, and maintain attention.

But many adolescents and young adults who use e-cigarettes say that vaping helps alleviate anxiety and keep them attentive, which adds to the complexity of their dependency, according to Dr. Boykan.

Nicotine “actually interrupts neural circuits, that it can be associated with more anxiety, depression, attention to learning, and susceptibility to other addictive substances,” she said. “That is enough to make it very scary.”

Jake also said a social environment in which so many of his friends vaped also made it difficult for him to quit.

“You’re hanging out with your friends at night, and all of them are using it, and you’re trying not to,” he said.

Jake eventually took a semester off from college for an unrelated surgery. He moved home, away from his vaping classmates. He eventually transferred to a different college and lived at home, where no one vaped and where he wasn’t allowed to smoke in the house, he said.

“He came home and we took him to a doctor, and they didn’t know quite how to handle kids and addiction to e-cigarettes,” Mrs. Warn said.

Not fully understanding the long-term health implications of e-cigarette use has precluded many clinicians from offering clear messaging on the risk of vaping to current and potential users.

“It’s taken pediatricians time to ask the right questions and recognize nicotine addiction” from vaping, said Dr. Boykan, who serves as chair of the Section on Nicotine and Tobacco Prevention and Treatment of the American Academy of Pediatrics. “It’s just hit us so fast.”

But once pediatricians do identify a nicotine dependency, it can be difficult to treat, Dr. Boykan said. Many pediatricians now recognize that e-cigarette addiction may occur in children as early as middle school.

“We don’t have a lot of evidence-based treatments for kids to recommend,” Dr. Boykan said.
 

Will vaping be a ‘phase?’

Aware of his vaping dependency and the possible risks to his long-term health, Jake, now 23, said he’s lessened his use, compared with his college days, but still struggles to kick the habit for good.

“I’d like to not be able to use all the time, not to feel the urge,” Jake said. “But I think over time it’ll just kind of phase out.”

But his mother said quitting may not be that simple.

“This will be a lifelong journey,” she said. “When I think of who he is, addiction is something he will always have. It’s a part of him now.”

Dr. Boykan, Ms. Schneider, and Dr. Nardis reported no relevant financial disclosures.

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

Jake Warn calls vaping “a toxic artificial love.”

Jake, of Winslow, Maine, was 16 years old when he began vaping. Unlike cigarettes, vaping can be odorless, and its smoke leaves no trace, which allowed him and his friends to use the devices in school bathrooms without fear of being caught.

He would use an entire cartridge containing the vape liquid, the equivalent of smoking one pack of tobacco cigarettes, within 1 school day. By the fall semester of his first year in college, Jake said his use had increased even more.

“It got pricey, so that’s when I really started to notice” the extent of his dependency, he said recently.

Vaping rates among teenagers in Maine doubled from 15.3% to 28.7% between 2017 and 2019, while Jake was in high school. In 2021, 11% of high schoolers across the nation said they regularly smoked e-cigarettes, and an estimated 28% have ever tried the devices, according to the Centers for Disease Control and Prevention.

The Food and Drug Administration classifies e-cigarettes as a tobacco product because many contain nicotine, which comes from tobacco. Like Jake, the habit is likely to carry into adulthood for many who start in their teenage years, experts say.

Electronic nicotine delivery systems (ENDS) such as vapes have been touted by their manufacturers and by some in the medical field as a healthier alternative to cigarettes and as a method to help smokers give up the habit.

But, that’s not how Jake – who had never used combustible cigarettes – picked up vaping, or how he sold the idea to his mother.

“It’s all organic and natural flavoring, it’s just flavored water,” Mary Lou Warn recalled her son saying to her. She researched the health effects of vaping but didn’t find much online. “I knew they were dangerous because you don’t put anything in your lungs that isn’t fresh air.”

A determined athlete in high school, Jake found that his asthma worsened as he transitioned to college, especially when he ran a track meet or during a soccer game.

Mrs. Warn noticed changes off the field, too.

“He was coughing constantly, he wasn’t sleeping well, he wasn’t eating well,” she said. “I knew the addiction was taking over.”

Vaping irritated Jake’s throat, and he would get nosebleeds that he couldn’t stop, she added.

Since Mrs. Warn first looked into the effects of e-cigarettes on respiratory health back in 2017, many studies have been conducted of the short-term health outcomes for first-time smokers who never used combustible tobacco products. Studies suggest that vaping may worsen bronchitis and asthma, raise blood pressure, interfere with brain development in young users, suppress the immune system, and increase the risk of developing a chronic lung disease (Am J Prev Med. 2020 Feb;58[2]:182-90). Studies of mice and cell cultures have found that the vapor or extracts from vapes damage the chemical structure of DNA.

Still, the limited number of long-term human studies has made it hard to know what the health outcomes of e-cigarette users will be in the future. Conclusive studies linking commercial cigarette use to deaths from heart disease and cancer didn’t emerge until the mid-1950s, decades after manufacturers began mass production and marketing in the early 20th century.

Years could pass before researchers gain a clearer understanding of the health implications of long-term e-cigarette use, according to Nigar Nargis, PhD, senior scientific director of tobacco control research at the American Cancer Society.

“There hasn’t been any such study to establish the direct link from ENDS to cancer, but it is understood that it [vaping] may promote the development of cancer and lung damage and inflammation,” Dr. Nargis said.

For decades, advocates built awareness of the harms of tobacco use, which led to a sharp decline in tobacco-related illnesses such as lung cancer. But Hilary Schneider, Maine’s director of government relations for the ACS Cancer Action Network, said she fears the uptick in the use of vapes – especially among those who never smoked or those who use both combustible cigarettes and e-cigarettes – may reverse declines in the rates of smoking-relating diseases.

Multiple studies suggest that inhaling chemicals found in e-cigarettes – including nicotine-carrying aerosols – can damage arteries and inflame and injure the lungs.

Vapes “basically have created a pediatric tobacco-use epidemic,” Ms. Schneider said. “What we’re seeing is unprecedented tobacco use rates, higher rates than we’ve seen in decades.”

One reason many young people start vaping is the attraction to flavors, which range from classic menthol to fruits and sweets. A handful of states have enacted bans or restrictions on the sale of flavored vapes.

“It’s new, and it’s just been marketed in a way that we’re really fighting the false narrative put out there by makers of these products that are trying to make them appealing to kids,” said Rachel Boykan, MD, clinical professor of pediatrics and attending physician at Stony Brook (N.Y.) Children’s Hospital.

The flavor Red Bull, in particular, hooked Jake. And though he wasn’t aware of it at the time, nicotine packed into the pods may have kept him from quitting: The average nicotine concentration in e-cigarettes more than doubled from 2013 to 2018, according to a study by the Truth Initiative and the CDC.

The immediate risks of nicotine on the developing brain are well documented. Studies suggest that nicotine – which is found in ENDS products – may affect adolescents’ ability to learn, remember, and maintain attention.

But many adolescents and young adults who use e-cigarettes say that vaping helps alleviate anxiety and keep them attentive, which adds to the complexity of their dependency, according to Dr. Boykan.

Nicotine “actually interrupts neural circuits, that it can be associated with more anxiety, depression, attention to learning, and susceptibility to other addictive substances,” she said. “That is enough to make it very scary.”

Jake also said a social environment in which so many of his friends vaped also made it difficult for him to quit.

“You’re hanging out with your friends at night, and all of them are using it, and you’re trying not to,” he said.

Jake eventually took a semester off from college for an unrelated surgery. He moved home, away from his vaping classmates. He eventually transferred to a different college and lived at home, where no one vaped and where he wasn’t allowed to smoke in the house, he said.

“He came home and we took him to a doctor, and they didn’t know quite how to handle kids and addiction to e-cigarettes,” Mrs. Warn said.

Not fully understanding the long-term health implications of e-cigarette use has precluded many clinicians from offering clear messaging on the risk of vaping to current and potential users.

“It’s taken pediatricians time to ask the right questions and recognize nicotine addiction” from vaping, said Dr. Boykan, who serves as chair of the Section on Nicotine and Tobacco Prevention and Treatment of the American Academy of Pediatrics. “It’s just hit us so fast.”

But once pediatricians do identify a nicotine dependency, it can be difficult to treat, Dr. Boykan said. Many pediatricians now recognize that e-cigarette addiction may occur in children as early as middle school.

“We don’t have a lot of evidence-based treatments for kids to recommend,” Dr. Boykan said.
 

Will vaping be a ‘phase?’

Aware of his vaping dependency and the possible risks to his long-term health, Jake, now 23, said he’s lessened his use, compared with his college days, but still struggles to kick the habit for good.

“I’d like to not be able to use all the time, not to feel the urge,” Jake said. “But I think over time it’ll just kind of phase out.”

But his mother said quitting may not be that simple.

“This will be a lifelong journey,” she said. “When I think of who he is, addiction is something he will always have. It’s a part of him now.”

Dr. Boykan, Ms. Schneider, and Dr. Nardis reported no relevant financial disclosures.

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

An alpha-synuclein seed amplification assay (αSyn-SAA) accurately identifies people with Parkinson’s disease, as well as those at risk for Parkinson’s disease and those with early, prodromal symptoms, and provides information on molecular subtypes, new research indicates.

“Identifying an effective biomarker for Parkinson’s disease pathology could have profound implications for the way we treat the condition, potentially making it possible to diagnose people earlier, identify the best treatments for different subsets of patients, and speed up clinical trials,” the study’s co-lead author Andrew Siderowf, MD, of the University of Pennsylvania, Philadelphia, said in a news release.

“Our findings suggest that the αSyn-SAA technique is highly accurate at detecting the biomarker for Parkinson’s disease regardless of the clinical features, making it possible to accurately diagnose the disease in patients at early stages,” added co-lead author Luis Concha-Marambio, PhD, director of research and development at Amprion, San Diego, Calif.

The study was published online in The Lancet Neurology.
 

‘New era’ in Parkinson’s disease

The researchers assessed the usefulness of αSyn-SAA in a cross-sectional analysis of 1,123 participants in the Parkinson’s Progression Markers Initiative (PPMI) cohort from 33 participating academic neurology outpatient practices in 12 countries.

The cohort included individuals with sporadic Parkinson’s disease from LRRK2 or GBA variants, healthy controls, individuals with clinical syndromes prodromal to Parkinson’s disease (rapid eye movement sleep behavior disorder [RBD] or hyposmia), and nonmanifesting carriers of LRRK2 and GBA variants. Cerebrospinal fluid (CSF) samples from each participant were analyzed using αSyn-SAA.

Overall, αSyn-SAA differentiated Parkinson’s disease from healthy controls with 87.7% sensitivity and 96.3% specificity.

Sensitivity of the assay varied across subgroups based on genetic and clinical features. Among genetic Parkinson’s disease subgroups, sensitivity was highest for GBA Parkinson’s disease (95.9%), followed by sporadic Parkinson’s disease (93.3%), and lowest for LRRK2 Parkinson’s disease (67.5%). Among clinical features, hyposmia was the most robust predictor of a positive assay result.

Among all Parkinson’s disease cases with hyposmia, the sensitivity of the assay was 97.2%, compared with 63.0% for Parkinson’s disease without olfactory dysfunction. Combining genetic and clinical features, the sensitivity of positive αSyn-SAA in sporadic Parkinson’s disease with olfactory deficit was 98.6%, compared with 78.3% in sporadic Parkinson’s disease without hyposmia. Most prodromal participants (86%) with RBD and hyposmia had positive αSyn-SAA results, indicating they had α-synuclein aggregates despite not yet being diagnosed with Parkinson’s disease.

Among those recruited based on their loss of smell, 89% (16 of 18 participants) had positive αSyn-SAA results. Similarly, in those with RBD, positive αSyn-SAA results were present in 85% of cases (28 of 33). No other clinical features were associated with a positive αSyn-SAA result.

In participants who carried LRRK2 or GBA variants but had no Parkinson’s disease diagnosis or prodromal symptoms (nonmanifesting carriers), 9% (14 of 159) and 7% (11 of 151), respectively, had positive αSyn-SAA results.

To date, this is the largest analysis of α-Syn-SAA for the biochemical diagnosis of Parkinson’s disease, the researchers said.

The results show that the assay classifies people with Parkinson’s disease with “high sensitivity and specificity, provides information about molecular heterogeneity, and detects prodromal individuals before diagnosis,” they wrote.

“These findings suggest a crucial role for the α-synuclein SAA in therapeutic development, both to identify pathologically defined subgroups of people with Parkinson’s disease and to establish biomarker-defined at-risk cohorts,” they added.

Amprion has commercialized the assay (SYNTap test), which can be ordered online.
 

‘Seminal development’

The authors of an accompanying editorial noted the study “lays the foundation for a biological diagnosis” of Parkinson’s disease. “We have entered a new era of biomarker and treatment development for Parkinson’s disease. The possibility of detecting a misfolded α-synuclein, the pathological hallmark of Parkinson’s disease, by employing an SSA, is a seminal development,” wrote Daniela Berg, MD, PhD, and Christine Klein, MD, with University Hospital Schleswig-Holstein, Germany.

“However, to fully leverage the enormous potential of the α-synuclein seed amplification, the test would have to be performed in blood rather than the CSF, a less invasive approach that has proven to be viable,” they added.

“Although the blood-based method needs to be further elaborated for scalability, α-synuclein SAA is a game changer in Parkinson’s disease diagnostics, research, and treatment trials,” they concluded.

The study was funded by The Michael J. Fox Foundation for Parkinson’s Research and a consortium of more than 40 private and philanthropic partners. Dr. Siderowf has declared consulting for Merck and Parkinson Study Group, and receiving honoraria from Bial. A full list of author disclosures is available with the original article. Dr. Berg and Dr. Klein have reported no relevant financial relationships.
 

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

An alpha-synuclein seed amplification assay (αSyn-SAA) accurately identifies people with Parkinson’s disease, as well as those at risk for Parkinson’s disease and those with early, prodromal symptoms, and provides information on molecular subtypes, new research indicates.

“Identifying an effective biomarker for Parkinson’s disease pathology could have profound implications for the way we treat the condition, potentially making it possible to diagnose people earlier, identify the best treatments for different subsets of patients, and speed up clinical trials,” the study’s co-lead author Andrew Siderowf, MD, of the University of Pennsylvania, Philadelphia, said in a news release.

“Our findings suggest that the αSyn-SAA technique is highly accurate at detecting the biomarker for Parkinson’s disease regardless of the clinical features, making it possible to accurately diagnose the disease in patients at early stages,” added co-lead author Luis Concha-Marambio, PhD, director of research and development at Amprion, San Diego, Calif.

The study was published online in The Lancet Neurology.
 

‘New era’ in Parkinson’s disease

The researchers assessed the usefulness of αSyn-SAA in a cross-sectional analysis of 1,123 participants in the Parkinson’s Progression Markers Initiative (PPMI) cohort from 33 participating academic neurology outpatient practices in 12 countries.

The cohort included individuals with sporadic Parkinson’s disease from LRRK2 or GBA variants, healthy controls, individuals with clinical syndromes prodromal to Parkinson’s disease (rapid eye movement sleep behavior disorder [RBD] or hyposmia), and nonmanifesting carriers of LRRK2 and GBA variants. Cerebrospinal fluid (CSF) samples from each participant were analyzed using αSyn-SAA.

Overall, αSyn-SAA differentiated Parkinson’s disease from healthy controls with 87.7% sensitivity and 96.3% specificity.

Sensitivity of the assay varied across subgroups based on genetic and clinical features. Among genetic Parkinson’s disease subgroups, sensitivity was highest for GBA Parkinson’s disease (95.9%), followed by sporadic Parkinson’s disease (93.3%), and lowest for LRRK2 Parkinson’s disease (67.5%). Among clinical features, hyposmia was the most robust predictor of a positive assay result.

Among all Parkinson’s disease cases with hyposmia, the sensitivity of the assay was 97.2%, compared with 63.0% for Parkinson’s disease without olfactory dysfunction. Combining genetic and clinical features, the sensitivity of positive αSyn-SAA in sporadic Parkinson’s disease with olfactory deficit was 98.6%, compared with 78.3% in sporadic Parkinson’s disease without hyposmia. Most prodromal participants (86%) with RBD and hyposmia had positive αSyn-SAA results, indicating they had α-synuclein aggregates despite not yet being diagnosed with Parkinson’s disease.

Among those recruited based on their loss of smell, 89% (16 of 18 participants) had positive αSyn-SAA results. Similarly, in those with RBD, positive αSyn-SAA results were present in 85% of cases (28 of 33). No other clinical features were associated with a positive αSyn-SAA result.

In participants who carried LRRK2 or GBA variants but had no Parkinson’s disease diagnosis or prodromal symptoms (nonmanifesting carriers), 9% (14 of 159) and 7% (11 of 151), respectively, had positive αSyn-SAA results.

To date, this is the largest analysis of α-Syn-SAA for the biochemical diagnosis of Parkinson’s disease, the researchers said.

The results show that the assay classifies people with Parkinson’s disease with “high sensitivity and specificity, provides information about molecular heterogeneity, and detects prodromal individuals before diagnosis,” they wrote.

“These findings suggest a crucial role for the α-synuclein SAA in therapeutic development, both to identify pathologically defined subgroups of people with Parkinson’s disease and to establish biomarker-defined at-risk cohorts,” they added.

Amprion has commercialized the assay (SYNTap test), which can be ordered online.
 

‘Seminal development’

The authors of an accompanying editorial noted the study “lays the foundation for a biological diagnosis” of Parkinson’s disease. “We have entered a new era of biomarker and treatment development for Parkinson’s disease. The possibility of detecting a misfolded α-synuclein, the pathological hallmark of Parkinson’s disease, by employing an SSA, is a seminal development,” wrote Daniela Berg, MD, PhD, and Christine Klein, MD, with University Hospital Schleswig-Holstein, Germany.

“However, to fully leverage the enormous potential of the α-synuclein seed amplification, the test would have to be performed in blood rather than the CSF, a less invasive approach that has proven to be viable,” they added.

“Although the blood-based method needs to be further elaborated for scalability, α-synuclein SAA is a game changer in Parkinson’s disease diagnostics, research, and treatment trials,” they concluded.

The study was funded by The Michael J. Fox Foundation for Parkinson’s Research and a consortium of more than 40 private and philanthropic partners. Dr. Siderowf has declared consulting for Merck and Parkinson Study Group, and receiving honoraria from Bial. A full list of author disclosures is available with the original article. Dr. Berg and Dr. Klein have reported no relevant financial relationships.
 

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

An alpha-synuclein seed amplification assay (αSyn-SAA) accurately identifies people with Parkinson’s disease, as well as those at risk for Parkinson’s disease and those with early, prodromal symptoms, and provides information on molecular subtypes, new research indicates.

“Identifying an effective biomarker for Parkinson’s disease pathology could have profound implications for the way we treat the condition, potentially making it possible to diagnose people earlier, identify the best treatments for different subsets of patients, and speed up clinical trials,” the study’s co-lead author Andrew Siderowf, MD, of the University of Pennsylvania, Philadelphia, said in a news release.

“Our findings suggest that the αSyn-SAA technique is highly accurate at detecting the biomarker for Parkinson’s disease regardless of the clinical features, making it possible to accurately diagnose the disease in patients at early stages,” added co-lead author Luis Concha-Marambio, PhD, director of research and development at Amprion, San Diego, Calif.

The study was published online in The Lancet Neurology.
 

‘New era’ in Parkinson’s disease

The researchers assessed the usefulness of αSyn-SAA in a cross-sectional analysis of 1,123 participants in the Parkinson’s Progression Markers Initiative (PPMI) cohort from 33 participating academic neurology outpatient practices in 12 countries.

The cohort included individuals with sporadic Parkinson’s disease from LRRK2 or GBA variants, healthy controls, individuals with clinical syndromes prodromal to Parkinson’s disease (rapid eye movement sleep behavior disorder [RBD] or hyposmia), and nonmanifesting carriers of LRRK2 and GBA variants. Cerebrospinal fluid (CSF) samples from each participant were analyzed using αSyn-SAA.

Overall, αSyn-SAA differentiated Parkinson’s disease from healthy controls with 87.7% sensitivity and 96.3% specificity.

Sensitivity of the assay varied across subgroups based on genetic and clinical features. Among genetic Parkinson’s disease subgroups, sensitivity was highest for GBA Parkinson’s disease (95.9%), followed by sporadic Parkinson’s disease (93.3%), and lowest for LRRK2 Parkinson’s disease (67.5%). Among clinical features, hyposmia was the most robust predictor of a positive assay result.

Among all Parkinson’s disease cases with hyposmia, the sensitivity of the assay was 97.2%, compared with 63.0% for Parkinson’s disease without olfactory dysfunction. Combining genetic and clinical features, the sensitivity of positive αSyn-SAA in sporadic Parkinson’s disease with olfactory deficit was 98.6%, compared with 78.3% in sporadic Parkinson’s disease without hyposmia. Most prodromal participants (86%) with RBD and hyposmia had positive αSyn-SAA results, indicating they had α-synuclein aggregates despite not yet being diagnosed with Parkinson’s disease.

Among those recruited based on their loss of smell, 89% (16 of 18 participants) had positive αSyn-SAA results. Similarly, in those with RBD, positive αSyn-SAA results were present in 85% of cases (28 of 33). No other clinical features were associated with a positive αSyn-SAA result.

In participants who carried LRRK2 or GBA variants but had no Parkinson’s disease diagnosis or prodromal symptoms (nonmanifesting carriers), 9% (14 of 159) and 7% (11 of 151), respectively, had positive αSyn-SAA results.

To date, this is the largest analysis of α-Syn-SAA for the biochemical diagnosis of Parkinson’s disease, the researchers said.

The results show that the assay classifies people with Parkinson’s disease with “high sensitivity and specificity, provides information about molecular heterogeneity, and detects prodromal individuals before diagnosis,” they wrote.

“These findings suggest a crucial role for the α-synuclein SAA in therapeutic development, both to identify pathologically defined subgroups of people with Parkinson’s disease and to establish biomarker-defined at-risk cohorts,” they added.

Amprion has commercialized the assay (SYNTap test), which can be ordered online.
 

‘Seminal development’

The authors of an accompanying editorial noted the study “lays the foundation for a biological diagnosis” of Parkinson’s disease. “We have entered a new era of biomarker and treatment development for Parkinson’s disease. The possibility of detecting a misfolded α-synuclein, the pathological hallmark of Parkinson’s disease, by employing an SSA, is a seminal development,” wrote Daniela Berg, MD, PhD, and Christine Klein, MD, with University Hospital Schleswig-Holstein, Germany.

“However, to fully leverage the enormous potential of the α-synuclein seed amplification, the test would have to be performed in blood rather than the CSF, a less invasive approach that has proven to be viable,” they added.

“Although the blood-based method needs to be further elaborated for scalability, α-synuclein SAA is a game changer in Parkinson’s disease diagnostics, research, and treatment trials,” they concluded.

The study was funded by The Michael J. Fox Foundation for Parkinson’s Research and a consortium of more than 40 private and philanthropic partners. Dr. Siderowf has declared consulting for Merck and Parkinson Study Group, and receiving honoraria from Bial. A full list of author disclosures is available with the original article. Dr. Berg and Dr. Klein have reported no relevant financial relationships.
 

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

Food insecurity is linked to a more rapid decline in executive function in older adults, a new study shows.

The findings were reported just weeks after a pandemic-era expansion in Supplemental Nutrition Assistance Program benefits ended, leading to less food assistance for about 5 million people over age 60 who participate in the program.

“Even though we found only a very small association between food insecurity and executive function, it’s still meaningful, because food insecurity is something we can prevent,” lead investigator Boeun Kim, PhD, MPH, RN, postdoctoral fellow at Johns Hopkins University School of Nursing, Baltimore, told this news organization.

The findings were published online  in JAMA Network Open.
 

National data

The number of Americans over 60 with food insecurity has more than doubled since 2007, with an estimated 5.2 million older adults reporting food insecurity in 2020.

Prior studies have linked malnutrition and food insecurity to a decline in cognitive function. Participating in food assistance programs such as SNAP is associated with slower memory decline in older adults.

However, to date, there has been no longitudinal study that has used data from a nationally representative sample of older Americans, which, Dr. Kim said, could limit generalizability of the findings.

To address that issue, investigators analyzed data from 3,037 participants in the National Health and Aging Trends Study, which includes community dwellers age 65 and older who receive Medicare.

Participants reported food insecurity over 7 years, from 2012 to 2019. Data on immediate memory, delayed memory, and executive function were from 2013 to 2020.

Food insecurity was defined as going without groceries due to limited ability or social support; a lack of hot meals related to functional limitation or no help; going without eating because of the inability to feed oneself or no available support; skipping meals due to insufficient food or money; or skipping meals for 5 days or more.

Immediate and delayed recall were assessed using a 10-item word-list memory task, and executive function was measured using a clock drawing test. Each year’s cognitive functions were linked to the prior year’s food insecurity data.

Over 7 years, 417 people, or 12.1%, experienced food insecurity at least once.

Those with food insecurity were more likely to be older, female, part of racial and ethnic minority groups, living alone, obese, and have a lower income and educational attainment, depressive symptoms, social isolation and disability, compared with those without food insecurity.

After adjusting for age, sex, race/ethnicity, educational level, income, marital status, body mass index, functional disability, social isolation, and other potential confounders, researchers found that food insecurity was associated with a more rapid decline in executive function (mean difference in annual change in executive function score, −0.04; 95% confidence interval, −0.09 to −0.003).

Food insecurity was not associated with baseline cognitive function scores or changes in immediate or delayed recall.

“Clinicians should be aware of the experience of food insecurity and the higher risk of cognitive decline so maybe they could do universal screening and refer people with food insecurity to programs that can help them access nutritious meals,” Dr. Kim said.
 

A sign of other problems?

Thomas Vidic, MD, said food insecurity often goes hand-in-hand with lack of medication adherence, lack of regular medical care, and a host of other issues. Dr. Vidic is a neurologist at the Elkhart Clinic, Ind., and an adjunct clinical professor of neurology at Indiana University.

“When a person has food insecurity, they likely have other problems, and they’re going to degenerate faster,” said Dr. Vidic, who was not part of the study. “This is one important component, and it’s one more way of getting a handle on people who are failing.”

Dr. Vidic, who has dealt with the issue of food insecurity with his own patients, said he suspects the self-report nature of the study may hide the true scale of the problem.

“I suspect the numbers might actually be higher,” he said, adding that the study fills a gap in the literature with a large, nationally representative sample.

“We’re looking for issues to help with the elderly as far as what can we do to keep dementia from progressing,” he said. “There are some things that make sense, but we’ve never had this kind of data before.”

The study was funded by the National Institute on Aging. Dr. Kim and Dr. Vidic have reported no relevant financial relationships.

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

Food insecurity is linked to a more rapid decline in executive function in older adults, a new study shows.

The findings were reported just weeks after a pandemic-era expansion in Supplemental Nutrition Assistance Program benefits ended, leading to less food assistance for about 5 million people over age 60 who participate in the program.

“Even though we found only a very small association between food insecurity and executive function, it’s still meaningful, because food insecurity is something we can prevent,” lead investigator Boeun Kim, PhD, MPH, RN, postdoctoral fellow at Johns Hopkins University School of Nursing, Baltimore, told this news organization.

The findings were published online  in JAMA Network Open.
 

National data

The number of Americans over 60 with food insecurity has more than doubled since 2007, with an estimated 5.2 million older adults reporting food insecurity in 2020.

Prior studies have linked malnutrition and food insecurity to a decline in cognitive function. Participating in food assistance programs such as SNAP is associated with slower memory decline in older adults.

However, to date, there has been no longitudinal study that has used data from a nationally representative sample of older Americans, which, Dr. Kim said, could limit generalizability of the findings.

To address that issue, investigators analyzed data from 3,037 participants in the National Health and Aging Trends Study, which includes community dwellers age 65 and older who receive Medicare.

Participants reported food insecurity over 7 years, from 2012 to 2019. Data on immediate memory, delayed memory, and executive function were from 2013 to 2020.

Food insecurity was defined as going without groceries due to limited ability or social support; a lack of hot meals related to functional limitation or no help; going without eating because of the inability to feed oneself or no available support; skipping meals due to insufficient food or money; or skipping meals for 5 days or more.

Immediate and delayed recall were assessed using a 10-item word-list memory task, and executive function was measured using a clock drawing test. Each year’s cognitive functions were linked to the prior year’s food insecurity data.

Over 7 years, 417 people, or 12.1%, experienced food insecurity at least once.

Those with food insecurity were more likely to be older, female, part of racial and ethnic minority groups, living alone, obese, and have a lower income and educational attainment, depressive symptoms, social isolation and disability, compared with those without food insecurity.

After adjusting for age, sex, race/ethnicity, educational level, income, marital status, body mass index, functional disability, social isolation, and other potential confounders, researchers found that food insecurity was associated with a more rapid decline in executive function (mean difference in annual change in executive function score, −0.04; 95% confidence interval, −0.09 to −0.003).

Food insecurity was not associated with baseline cognitive function scores or changes in immediate or delayed recall.

“Clinicians should be aware of the experience of food insecurity and the higher risk of cognitive decline so maybe they could do universal screening and refer people with food insecurity to programs that can help them access nutritious meals,” Dr. Kim said.
 

A sign of other problems?

Thomas Vidic, MD, said food insecurity often goes hand-in-hand with lack of medication adherence, lack of regular medical care, and a host of other issues. Dr. Vidic is a neurologist at the Elkhart Clinic, Ind., and an adjunct clinical professor of neurology at Indiana University.

“When a person has food insecurity, they likely have other problems, and they’re going to degenerate faster,” said Dr. Vidic, who was not part of the study. “This is one important component, and it’s one more way of getting a handle on people who are failing.”

Dr. Vidic, who has dealt with the issue of food insecurity with his own patients, said he suspects the self-report nature of the study may hide the true scale of the problem.

“I suspect the numbers might actually be higher,” he said, adding that the study fills a gap in the literature with a large, nationally representative sample.

“We’re looking for issues to help with the elderly as far as what can we do to keep dementia from progressing,” he said. “There are some things that make sense, but we’ve never had this kind of data before.”

The study was funded by the National Institute on Aging. Dr. Kim and Dr. Vidic have reported no relevant financial relationships.

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

Food insecurity is linked to a more rapid decline in executive function in older adults, a new study shows.

The findings were reported just weeks after a pandemic-era expansion in Supplemental Nutrition Assistance Program benefits ended, leading to less food assistance for about 5 million people over age 60 who participate in the program.

“Even though we found only a very small association between food insecurity and executive function, it’s still meaningful, because food insecurity is something we can prevent,” lead investigator Boeun Kim, PhD, MPH, RN, postdoctoral fellow at Johns Hopkins University School of Nursing, Baltimore, told this news organization.

The findings were published online  in JAMA Network Open.
 

National data

The number of Americans over 60 with food insecurity has more than doubled since 2007, with an estimated 5.2 million older adults reporting food insecurity in 2020.

Prior studies have linked malnutrition and food insecurity to a decline in cognitive function. Participating in food assistance programs such as SNAP is associated with slower memory decline in older adults.

However, to date, there has been no longitudinal study that has used data from a nationally representative sample of older Americans, which, Dr. Kim said, could limit generalizability of the findings.

To address that issue, investigators analyzed data from 3,037 participants in the National Health and Aging Trends Study, which includes community dwellers age 65 and older who receive Medicare.

Participants reported food insecurity over 7 years, from 2012 to 2019. Data on immediate memory, delayed memory, and executive function were from 2013 to 2020.

Food insecurity was defined as going without groceries due to limited ability or social support; a lack of hot meals related to functional limitation or no help; going without eating because of the inability to feed oneself or no available support; skipping meals due to insufficient food or money; or skipping meals for 5 days or more.

Immediate and delayed recall were assessed using a 10-item word-list memory task, and executive function was measured using a clock drawing test. Each year’s cognitive functions were linked to the prior year’s food insecurity data.

Over 7 years, 417 people, or 12.1%, experienced food insecurity at least once.

Those with food insecurity were more likely to be older, female, part of racial and ethnic minority groups, living alone, obese, and have a lower income and educational attainment, depressive symptoms, social isolation and disability, compared with those without food insecurity.

After adjusting for age, sex, race/ethnicity, educational level, income, marital status, body mass index, functional disability, social isolation, and other potential confounders, researchers found that food insecurity was associated with a more rapid decline in executive function (mean difference in annual change in executive function score, −0.04; 95% confidence interval, −0.09 to −0.003).

Food insecurity was not associated with baseline cognitive function scores or changes in immediate or delayed recall.

“Clinicians should be aware of the experience of food insecurity and the higher risk of cognitive decline so maybe they could do universal screening and refer people with food insecurity to programs that can help them access nutritious meals,” Dr. Kim said.
 

A sign of other problems?

Thomas Vidic, MD, said food insecurity often goes hand-in-hand with lack of medication adherence, lack of regular medical care, and a host of other issues. Dr. Vidic is a neurologist at the Elkhart Clinic, Ind., and an adjunct clinical professor of neurology at Indiana University.

“When a person has food insecurity, they likely have other problems, and they’re going to degenerate faster,” said Dr. Vidic, who was not part of the study. “This is one important component, and it’s one more way of getting a handle on people who are failing.”

Dr. Vidic, who has dealt with the issue of food insecurity with his own patients, said he suspects the self-report nature of the study may hide the true scale of the problem.

“I suspect the numbers might actually be higher,” he said, adding that the study fills a gap in the literature with a large, nationally representative sample.

“We’re looking for issues to help with the elderly as far as what can we do to keep dementia from progressing,” he said. “There are some things that make sense, but we’ve never had this kind of data before.”

The study was funded by the National Institute on Aging. Dr. Kim and Dr. Vidic have reported no relevant financial relationships.

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

Findings from a landmark clinical trial in pediatric Crohn’s disease show a clear benefit of adding methotrexate to treatment with the tumor necrosis factor inhibitor (TNFi) adalimumab (Humira) but not to infliximab therapy.

Children initiating treatment with adalimumab plus a low dose of methotrexate experienced a twofold reduction in treatment failure, note the authors of the largest, double-blind, randomized trial to date in pediatric Crohn’s disease. However, children initiating infliximab, another TNFi, had similar outcomes with or without methotrexate.

“We believe these results are practice-changing,” said principal investigator Michael Kappelman, MD, MPH, professor of pediatrics at University of North Carolina, Chapel Hill.

All patients with pediatric Crohn’s disease starting on adalimumab and their parents should be informed that combining the drug with low-dose oral methotrexate improves treatment effectiveness, he said.

“Those without contraindications should be offered combination therapy, and shared decision-making should be incorporated into final treatment decisions. In contrast, most patients starting infliximab are not likely to experience added benefits from low-dose oral methotrexate,” Dr. Kappelman added.

The study was published online  in Gastroenterology and will be presented in early May at Digestive Disease Week® 2023.

Impactful study

“This is an important study, published in a very high-ranking journal, that will have a huge impact on how we practice,” said Jacob Kurowski, MD, department of pediatric gastroenterology, hepatology, and nutrition, Cleveland Clinic Children’s, who wasn’t involved in the study.

Treatment with a TNFi, including infliximab and adalimumab, is a mainstay of pediatric Crohn’s disease therapy. However, not all patients achieve remission, and many lose response over time.

The current trial compared the effectiveness and safety of adding a low-dose of oral methotrexate to adalimumab or infliximab versus TNFi therapy alone in 297 children with Crohn’s disease.

The mean age was 13.9 years, and about two-thirds were boys. None had a prior history of TNFi therapy.

Participants initiating infliximab or adalimumab were randomly allocated (1:1) to oral methotrexate or placebo. Of them, 110 infliximab initiators and 46 adalimumab initiators received methotrexate, while 102 infliximab initiators and 39 adalimumab initiators were given placebo. Methotrexate was administered as a weekly dose of 15 mg for children weighing 40 kg or more, 12.5 mg for children 30 to less than 40 kg, and 10 mg for children 20 to less than 30 kg. All participants received pretreatment with ondansetron 4 mg (or placebo) to prevent nausea and folic acid (1 mg per day). Participants were followed for 12-36 months.

The primary outcome was a failure to achieve or maintain steroid-free remission defined by occurrence of any of the following.

• Short Pediatric Crohn’s Disease Activity Index score of less than 15 by week 26
• Failure to complete a steroid taper by week 16
• SPCDAI score of 15 or higher as a result of active Crohn’s disease at two or more consecutive visits beyond week 26
• Hospitalization or surgery for Crohn’s disease beyond week 26
• Use of corticosteroids for Crohn’s disease for 10 or more weeks cumulatively beyond week 16
• Discontinuation of anti-TNF and/or study drug for lack of effectiveness or toxicity

Overall, 88 of 297 children (30%) experienced treatment failure, including 57 of 212 (27%) on infliximab and 31 of 85 (36%) on adalimumab. Overall, 40 of 156 children (26%) on combination therapy and 48 of 141 (34%) on monotherapy experienced treatment failure.

Kaplan Meier analysis of the overall population showed a nonsignificant trend toward lower event rates with combination therapy (hazard ratio, 0.69; 95% confidence interval, 0.45-1.05; P = .08).

After stratification by TNFi, there was no difference in time to treatment failure among infliximab initiators between combination and monotherapy (HR, 0.93; 95% CI, 0.55-1.56; P = .78). In contrast, among adalimumab initiators, combination therapy was significantly associated with a longer time to treatment failure (HR, 0.40; 95% CI, 0.19-0.81; P = .01).

There was a nonsignificant trend toward lower development of anti-drug antibodies with combination therapy (risk ratio, 0.72 with infliximab and 0.71 with adalimumab). This trend is in line with adult studies and adds substantially to the pediatric literature on this topic, the researchers noted.

No differences in patient-reported outcomes were observed. There were slightly more adverse events with combination therapy, as expected, but fewer serious adverse events.
 

Shared decision-making

Dr. Kappelman noted that the study was not designed to answer the question of which is better – adalimumab plus methotrexate or infliximab alone. “This is an area for future research. At this point, we believe it is an individualized decision, and appropriate counseling is needed to support shared decision-making,” he said.

Nor was the trial designed to evaluate the role of proactive therapeutic drug monitoring. However, proactive TDM is endorsed in the ImproveCareNow Model IBD Care guidelines and was considered standard of care at the 35 study sites.

The findings “suggest strong consideration of using combination therapy for pediatric Crohn’s disease patients initiating adalimumab but not infliximab,” Dr. Kappelman and colleagues said.

“Dissemination and implementation of these findings should lead to improved outcomes in this patient population, including consideration of de-implementation of combination therapy in infliximab treated patients,” they added.

The decision about which approach to use is still very dependent on patients and their providers, Dr. Kurowski said.

“The study shows that you can safely use infliximab as monotherapy, with low risk of antibody formation, while utilizing proactive therapeutic drug monitoring and dose optimization. The study also shows that adalimumab in combination with low-dose methotrexate can be strongly considered when needed.”

The researchers’ standardization of methotrexate doses by weight “is another significant contribution and provides a guide for clinicians,” Dr. Kurowski added.

The study was funded by grants from the Patient-Centered Outcomes Research Institute, the Helmsley Charitable Trust, and National Institute of Arthritis and Musculoskeletal and Skin Diseases. Dr. Kappelman has consulted for AbbVie, Janssen, Pfizer, Takeda, and Lilly; holds shares in Johnson & Johnson; and has received research support from Pfizer, Takeda, Janssen, AbbVie, Lilly, Genentech, Boehringer Ingelheim, Bristol-Myers Squibb, Celtrion, and Arena Pharmaceuticals. Dr. Kurowski reports no relevant financial relationships.

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

Findings from a landmark clinical trial in pediatric Crohn’s disease show a clear benefit of adding methotrexate to treatment with the tumor necrosis factor inhibitor (TNFi) adalimumab (Humira) but not to infliximab therapy.

Children initiating treatment with adalimumab plus a low dose of methotrexate experienced a twofold reduction in treatment failure, note the authors of the largest, double-blind, randomized trial to date in pediatric Crohn’s disease. However, children initiating infliximab, another TNFi, had similar outcomes with or without methotrexate.

“We believe these results are practice-changing,” said principal investigator Michael Kappelman, MD, MPH, professor of pediatrics at University of North Carolina, Chapel Hill.

All patients with pediatric Crohn’s disease starting on adalimumab and their parents should be informed that combining the drug with low-dose oral methotrexate improves treatment effectiveness, he said.

“Those without contraindications should be offered combination therapy, and shared decision-making should be incorporated into final treatment decisions. In contrast, most patients starting infliximab are not likely to experience added benefits from low-dose oral methotrexate,” Dr. Kappelman added.

The study was published online  in Gastroenterology and will be presented in early May at Digestive Disease Week® 2023.

Impactful study

“This is an important study, published in a very high-ranking journal, that will have a huge impact on how we practice,” said Jacob Kurowski, MD, department of pediatric gastroenterology, hepatology, and nutrition, Cleveland Clinic Children’s, who wasn’t involved in the study.

Treatment with a TNFi, including infliximab and adalimumab, is a mainstay of pediatric Crohn’s disease therapy. However, not all patients achieve remission, and many lose response over time.

The current trial compared the effectiveness and safety of adding a low-dose of oral methotrexate to adalimumab or infliximab versus TNFi therapy alone in 297 children with Crohn’s disease.

The mean age was 13.9 years, and about two-thirds were boys. None had a prior history of TNFi therapy.

Participants initiating infliximab or adalimumab were randomly allocated (1:1) to oral methotrexate or placebo. Of them, 110 infliximab initiators and 46 adalimumab initiators received methotrexate, while 102 infliximab initiators and 39 adalimumab initiators were given placebo. Methotrexate was administered as a weekly dose of 15 mg for children weighing 40 kg or more, 12.5 mg for children 30 to less than 40 kg, and 10 mg for children 20 to less than 30 kg. All participants received pretreatment with ondansetron 4 mg (or placebo) to prevent nausea and folic acid (1 mg per day). Participants were followed for 12-36 months.

The primary outcome was a failure to achieve or maintain steroid-free remission defined by occurrence of any of the following.

• Short Pediatric Crohn’s Disease Activity Index score of less than 15 by week 26
• Failure to complete a steroid taper by week 16
• SPCDAI score of 15 or higher as a result of active Crohn’s disease at two or more consecutive visits beyond week 26
• Hospitalization or surgery for Crohn’s disease beyond week 26
• Use of corticosteroids for Crohn’s disease for 10 or more weeks cumulatively beyond week 16
• Discontinuation of anti-TNF and/or study drug for lack of effectiveness or toxicity

Overall, 88 of 297 children (30%) experienced treatment failure, including 57 of 212 (27%) on infliximab and 31 of 85 (36%) on adalimumab. Overall, 40 of 156 children (26%) on combination therapy and 48 of 141 (34%) on monotherapy experienced treatment failure.

Kaplan Meier analysis of the overall population showed a nonsignificant trend toward lower event rates with combination therapy (hazard ratio, 0.69; 95% confidence interval, 0.45-1.05; P = .08).

After stratification by TNFi, there was no difference in time to treatment failure among infliximab initiators between combination and monotherapy (HR, 0.93; 95% CI, 0.55-1.56; P = .78). In contrast, among adalimumab initiators, combination therapy was significantly associated with a longer time to treatment failure (HR, 0.40; 95% CI, 0.19-0.81; P = .01).

There was a nonsignificant trend toward lower development of anti-drug antibodies with combination therapy (risk ratio, 0.72 with infliximab and 0.71 with adalimumab). This trend is in line with adult studies and adds substantially to the pediatric literature on this topic, the researchers noted.

No differences in patient-reported outcomes were observed. There were slightly more adverse events with combination therapy, as expected, but fewer serious adverse events.
 

Shared decision-making

Dr. Kappelman noted that the study was not designed to answer the question of which is better – adalimumab plus methotrexate or infliximab alone. “This is an area for future research. At this point, we believe it is an individualized decision, and appropriate counseling is needed to support shared decision-making,” he said.

Nor was the trial designed to evaluate the role of proactive therapeutic drug monitoring. However, proactive TDM is endorsed in the ImproveCareNow Model IBD Care guidelines and was considered standard of care at the 35 study sites.

The findings “suggest strong consideration of using combination therapy for pediatric Crohn’s disease patients initiating adalimumab but not infliximab,” Dr. Kappelman and colleagues said.

“Dissemination and implementation of these findings should lead to improved outcomes in this patient population, including consideration of de-implementation of combination therapy in infliximab treated patients,” they added.

The decision about which approach to use is still very dependent on patients and their providers, Dr. Kurowski said.

“The study shows that you can safely use infliximab as monotherapy, with low risk of antibody formation, while utilizing proactive therapeutic drug monitoring and dose optimization. The study also shows that adalimumab in combination with low-dose methotrexate can be strongly considered when needed.”

The researchers’ standardization of methotrexate doses by weight “is another significant contribution and provides a guide for clinicians,” Dr. Kurowski added.

The study was funded by grants from the Patient-Centered Outcomes Research Institute, the Helmsley Charitable Trust, and National Institute of Arthritis and Musculoskeletal and Skin Diseases. Dr. Kappelman has consulted for AbbVie, Janssen, Pfizer, Takeda, and Lilly; holds shares in Johnson & Johnson; and has received research support from Pfizer, Takeda, Janssen, AbbVie, Lilly, Genentech, Boehringer Ingelheim, Bristol-Myers Squibb, Celtrion, and Arena Pharmaceuticals. Dr. Kurowski reports no relevant financial relationships.

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

Findings from a landmark clinical trial in pediatric Crohn’s disease show a clear benefit of adding methotrexate to treatment with the tumor necrosis factor inhibitor (TNFi) adalimumab (Humira) but not to infliximab therapy.

Children initiating treatment with adalimumab plus a low dose of methotrexate experienced a twofold reduction in treatment failure, note the authors of the largest, double-blind, randomized trial to date in pediatric Crohn’s disease. However, children initiating infliximab, another TNFi, had similar outcomes with or without methotrexate.

“We believe these results are practice-changing,” said principal investigator Michael Kappelman, MD, MPH, professor of pediatrics at University of North Carolina, Chapel Hill.

All patients with pediatric Crohn’s disease starting on adalimumab and their parents should be informed that combining the drug with low-dose oral methotrexate improves treatment effectiveness, he said.

“Those without contraindications should be offered combination therapy, and shared decision-making should be incorporated into final treatment decisions. In contrast, most patients starting infliximab are not likely to experience added benefits from low-dose oral methotrexate,” Dr. Kappelman added.

The study was published online  in Gastroenterology and will be presented in early May at Digestive Disease Week® 2023.

Impactful study

“This is an important study, published in a very high-ranking journal, that will have a huge impact on how we practice,” said Jacob Kurowski, MD, department of pediatric gastroenterology, hepatology, and nutrition, Cleveland Clinic Children’s, who wasn’t involved in the study.

Treatment with a TNFi, including infliximab and adalimumab, is a mainstay of pediatric Crohn’s disease therapy. However, not all patients achieve remission, and many lose response over time.

The current trial compared the effectiveness and safety of adding a low-dose of oral methotrexate to adalimumab or infliximab versus TNFi therapy alone in 297 children with Crohn’s disease.

The mean age was 13.9 years, and about two-thirds were boys. None had a prior history of TNFi therapy.

Participants initiating infliximab or adalimumab were randomly allocated (1:1) to oral methotrexate or placebo. Of them, 110 infliximab initiators and 46 adalimumab initiators received methotrexate, while 102 infliximab initiators and 39 adalimumab initiators were given placebo. Methotrexate was administered as a weekly dose of 15 mg for children weighing 40 kg or more, 12.5 mg for children 30 to less than 40 kg, and 10 mg for children 20 to less than 30 kg. All participants received pretreatment with ondansetron 4 mg (or placebo) to prevent nausea and folic acid (1 mg per day). Participants were followed for 12-36 months.

The primary outcome was a failure to achieve or maintain steroid-free remission defined by occurrence of any of the following.

• Short Pediatric Crohn’s Disease Activity Index score of less than 15 by week 26
• Failure to complete a steroid taper by week 16
• SPCDAI score of 15 or higher as a result of active Crohn’s disease at two or more consecutive visits beyond week 26
• Hospitalization or surgery for Crohn’s disease beyond week 26
• Use of corticosteroids for Crohn’s disease for 10 or more weeks cumulatively beyond week 16
• Discontinuation of anti-TNF and/or study drug for lack of effectiveness or toxicity

Overall, 88 of 297 children (30%) experienced treatment failure, including 57 of 212 (27%) on infliximab and 31 of 85 (36%) on adalimumab. Overall, 40 of 156 children (26%) on combination therapy and 48 of 141 (34%) on monotherapy experienced treatment failure.

Kaplan Meier analysis of the overall population showed a nonsignificant trend toward lower event rates with combination therapy (hazard ratio, 0.69; 95% confidence interval, 0.45-1.05; P = .08).

After stratification by TNFi, there was no difference in time to treatment failure among infliximab initiators between combination and monotherapy (HR, 0.93; 95% CI, 0.55-1.56; P = .78). In contrast, among adalimumab initiators, combination therapy was significantly associated with a longer time to treatment failure (HR, 0.40; 95% CI, 0.19-0.81; P = .01).

There was a nonsignificant trend toward lower development of anti-drug antibodies with combination therapy (risk ratio, 0.72 with infliximab and 0.71 with adalimumab). This trend is in line with adult studies and adds substantially to the pediatric literature on this topic, the researchers noted.

No differences in patient-reported outcomes were observed. There were slightly more adverse events with combination therapy, as expected, but fewer serious adverse events.
 

Shared decision-making

Dr. Kappelman noted that the study was not designed to answer the question of which is better – adalimumab plus methotrexate or infliximab alone. “This is an area for future research. At this point, we believe it is an individualized decision, and appropriate counseling is needed to support shared decision-making,” he said.

Nor was the trial designed to evaluate the role of proactive therapeutic drug monitoring. However, proactive TDM is endorsed in the ImproveCareNow Model IBD Care guidelines and was considered standard of care at the 35 study sites.

The findings “suggest strong consideration of using combination therapy for pediatric Crohn’s disease patients initiating adalimumab but not infliximab,” Dr. Kappelman and colleagues said.

“Dissemination and implementation of these findings should lead to improved outcomes in this patient population, including consideration of de-implementation of combination therapy in infliximab treated patients,” they added.

The decision about which approach to use is still very dependent on patients and their providers, Dr. Kurowski said.

“The study shows that you can safely use infliximab as monotherapy, with low risk of antibody formation, while utilizing proactive therapeutic drug monitoring and dose optimization. The study also shows that adalimumab in combination with low-dose methotrexate can be strongly considered when needed.”

The researchers’ standardization of methotrexate doses by weight “is another significant contribution and provides a guide for clinicians,” Dr. Kurowski added.

The study was funded by grants from the Patient-Centered Outcomes Research Institute, the Helmsley Charitable Trust, and National Institute of Arthritis and Musculoskeletal and Skin Diseases. Dr. Kappelman has consulted for AbbVie, Janssen, Pfizer, Takeda, and Lilly; holds shares in Johnson & Johnson; and has received research support from Pfizer, Takeda, Janssen, AbbVie, Lilly, Genentech, Boehringer Ingelheim, Bristol-Myers Squibb, Celtrion, and Arena Pharmaceuticals. Dr. Kurowski reports no relevant financial relationships.

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

Early parathyroidectomy within 1 year of diagnosis of primary hyperparathyroidism (PHPT) did not reduce the risk of a sustained decline in kidney function, measured by a decline in estimated glomerular filtration rate (eGFR) of at least 50%, compared with observation (no surgery) in adults aged 60 and older.

Early parathyroidectomy was, however, associated with a reduced adjusted risk of this decline in kidney function in patients with newly diagnosed PHPT who were younger than age 60.

The findings, based on data from close to 43,000 veterans, were published online in Annals of Internal Medicine.

“The important takeaway from our study is that for older adults [age 60 or older] with primary hyperparathyroidism, preservation of kidney function should not be a primary consideration when making decisions about whether to undergo parathyroidectomy,” lead author Carolyn D. Seib, MD, told this news organization.

“It is important that physicians also discuss with their patients the potential long-term benefits of parathyroidectomy related to a reduced risk of fractures, kidney stones, and cardiovascular disease, and improved quality of life, in addition to the need for lifelong surveillance if surgery is declined, weighing these against an individual patient’s risk of surgery,” said Dr. Seib, a surgeon at Palo Alto (Calif.) VA Medical Center.

“However, in patients younger than 60, early parathyroidectomy may prevent progression to chronic kidney disease (CKD) and should be more strongly considered,” she noted.

Parathyroidectomy, she observed, is a low-risk outpatient surgery for most adults.

“Potential complications of surgery include temporary or permanent hoarseness, hypoparathyroidism (low postoperative parathyroid function), bleeding requiring return to the operating room, and complications related to general anesthesia, all of which are rare,” said Dr. Seib.

“Surgery by a high-volume surgeon is associated with a reduced risk of complications, so patients should seek out an experienced parathyroid surgeon,” she emphasized.  

Moreover, parathyroidectomy is the only treatment for primary hyperparathyroidism.
 

Does parathyroidectomy slow loss of kidney function?

Multidisciplinary guidelines recommend parathyroidectomy, at least in part to mitigate the risk for, and effects related to, the progression of CKD in patients with PHPT and an eGFR below 60 mL/min per 1.73 m², the researchers wrote.

However, whether parathyroidectomy slows the loss of kidney function in adults with PHPT is not clear.

Guidelines also state that “observation for PHPT disease progression can be considered when patients have no obvious end organ damage (i.e., eGFR > 60 mL/min per 1.73 m², normal bone mineral density, and no history of kidney stones or fractures),” Dr. Seib noted.  

To address the evidence gap, the researchers emulated a randomized target trial using observational data.

In this type of study, Dr. Seib explained, “although patients aren’t randomly assigned to a treatment, complex statistical methods are used to adjust for baseline confounders in an attempt to emulate random treatment assignment and account for bias that may affect the timing of when patients receive treatment.”

Using national Veterans Health Administration data, researchers identified 43,697 veterans with a new biochemical diagnosis of PHPT, defined as elevated parathyroid hormone (> 65 ng/mL) within 6 months of an elevated serum calcium level (> 32.55 mmol/L or >10.2 mg/dL), from 2000 to 2019.

Of these patients, 3,804 underwent parathyroidectomy within 1 year of diagnosis of PHPT, and 39,893 did not, and instead, a watchful waiting approach was adopted.

To be included in the analysis, patients had to have an eGFR above 30 mL/min per 1.73 m² for 12 months before PHPT diagnosis to exclude secondary or tertiary hyperparathyroidism.

The primary outcome was a sustained decline in eGFR of at least 50% from baseline.

In the overall cohort, patients had a mean pretreatment eGFR of 71.8 mL/min per 1.73 m². The mean age of patients was 67, 88% were men, and 68% were White.

After a median follow-up of 4.9 years, 6.7% of the patients had a decline in eGFR of at least 50%.

The cumulative incidence of this decline in eGFR was 5.1% at 5 years and 10.8% at 10 years in patients who had had early parathyroidectomy compared with 5.1% and 12.0%, respectively, in patients who did not undergo surgery.

In the overall population, the risk of at least a 50% decline in eGFR was similar in the early parathyroidectomy group versus the observation group (adjusted hazard ratio [HR], 0.98, 95% confidence interval [CI], 0.82-1.16).

However, diving deeper showed that parathyroidectomy was associated with a reduced risk of the primary outcome among patients younger than 60 years (adjusted HR, 0.75, 95% CI, 0.59-0.93) but not among those aged 60 or older (adjusted HR, 1.08, 95% CI, 0.87-1.34).

“When participating in shared decision-making for older adults [age 60 and older] with PHPT, clinicians should not consider parathyroidectomy for potential benefits of preservation of kidney function,” the researchers reiterated.

“For younger patients, clinicians should discuss the potential benefit of parathyroidectomy to reduce the risk for CKD and associated complications in adults with PHPT,” they concluded.

The study was funded by the National Institute on Aging. The authors reported no relevant financial relationships.

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

Early parathyroidectomy within 1 year of diagnosis of primary hyperparathyroidism (PHPT) did not reduce the risk of a sustained decline in kidney function, measured by a decline in estimated glomerular filtration rate (eGFR) of at least 50%, compared with observation (no surgery) in adults aged 60 and older.

Early parathyroidectomy was, however, associated with a reduced adjusted risk of this decline in kidney function in patients with newly diagnosed PHPT who were younger than age 60.

The findings, based on data from close to 43,000 veterans, were published online in Annals of Internal Medicine.

“The important takeaway from our study is that for older adults [age 60 or older] with primary hyperparathyroidism, preservation of kidney function should not be a primary consideration when making decisions about whether to undergo parathyroidectomy,” lead author Carolyn D. Seib, MD, told this news organization.

“It is important that physicians also discuss with their patients the potential long-term benefits of parathyroidectomy related to a reduced risk of fractures, kidney stones, and cardiovascular disease, and improved quality of life, in addition to the need for lifelong surveillance if surgery is declined, weighing these against an individual patient’s risk of surgery,” said Dr. Seib, a surgeon at Palo Alto (Calif.) VA Medical Center.

“However, in patients younger than 60, early parathyroidectomy may prevent progression to chronic kidney disease (CKD) and should be more strongly considered,” she noted.

Parathyroidectomy, she observed, is a low-risk outpatient surgery for most adults.

“Potential complications of surgery include temporary or permanent hoarseness, hypoparathyroidism (low postoperative parathyroid function), bleeding requiring return to the operating room, and complications related to general anesthesia, all of which are rare,” said Dr. Seib.

“Surgery by a high-volume surgeon is associated with a reduced risk of complications, so patients should seek out an experienced parathyroid surgeon,” she emphasized.  

Moreover, parathyroidectomy is the only treatment for primary hyperparathyroidism.
 

Does parathyroidectomy slow loss of kidney function?

Multidisciplinary guidelines recommend parathyroidectomy, at least in part to mitigate the risk for, and effects related to, the progression of CKD in patients with PHPT and an eGFR below 60 mL/min per 1.73 m², the researchers wrote.

However, whether parathyroidectomy slows the loss of kidney function in adults with PHPT is not clear.

Guidelines also state that “observation for PHPT disease progression can be considered when patients have no obvious end organ damage (i.e., eGFR > 60 mL/min per 1.73 m², normal bone mineral density, and no history of kidney stones or fractures),” Dr. Seib noted.  

To address the evidence gap, the researchers emulated a randomized target trial using observational data.

In this type of study, Dr. Seib explained, “although patients aren’t randomly assigned to a treatment, complex statistical methods are used to adjust for baseline confounders in an attempt to emulate random treatment assignment and account for bias that may affect the timing of when patients receive treatment.”

Using national Veterans Health Administration data, researchers identified 43,697 veterans with a new biochemical diagnosis of PHPT, defined as elevated parathyroid hormone (> 65 ng/mL) within 6 months of an elevated serum calcium level (> 32.55 mmol/L or >10.2 mg/dL), from 2000 to 2019.

Of these patients, 3,804 underwent parathyroidectomy within 1 year of diagnosis of PHPT, and 39,893 did not, and instead, a watchful waiting approach was adopted.

To be included in the analysis, patients had to have an eGFR above 30 mL/min per 1.73 m² for 12 months before PHPT diagnosis to exclude secondary or tertiary hyperparathyroidism.

The primary outcome was a sustained decline in eGFR of at least 50% from baseline.

In the overall cohort, patients had a mean pretreatment eGFR of 71.8 mL/min per 1.73 m². The mean age of patients was 67, 88% were men, and 68% were White.

After a median follow-up of 4.9 years, 6.7% of the patients had a decline in eGFR of at least 50%.

The cumulative incidence of this decline in eGFR was 5.1% at 5 years and 10.8% at 10 years in patients who had had early parathyroidectomy compared with 5.1% and 12.0%, respectively, in patients who did not undergo surgery.

In the overall population, the risk of at least a 50% decline in eGFR was similar in the early parathyroidectomy group versus the observation group (adjusted hazard ratio [HR], 0.98, 95% confidence interval [CI], 0.82-1.16).

However, diving deeper showed that parathyroidectomy was associated with a reduced risk of the primary outcome among patients younger than 60 years (adjusted HR, 0.75, 95% CI, 0.59-0.93) but not among those aged 60 or older (adjusted HR, 1.08, 95% CI, 0.87-1.34).

“When participating in shared decision-making for older adults [age 60 and older] with PHPT, clinicians should not consider parathyroidectomy for potential benefits of preservation of kidney function,” the researchers reiterated.

“For younger patients, clinicians should discuss the potential benefit of parathyroidectomy to reduce the risk for CKD and associated complications in adults with PHPT,” they concluded.

The study was funded by the National Institute on Aging. The authors reported no relevant financial relationships.

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

Early parathyroidectomy within 1 year of diagnosis of primary hyperparathyroidism (PHPT) did not reduce the risk of a sustained decline in kidney function, measured by a decline in estimated glomerular filtration rate (eGFR) of at least 50%, compared with observation (no surgery) in adults aged 60 and older.

Early parathyroidectomy was, however, associated with a reduced adjusted risk of this decline in kidney function in patients with newly diagnosed PHPT who were younger than age 60.

The findings, based on data from close to 43,000 veterans, were published online in Annals of Internal Medicine.

“The important takeaway from our study is that for older adults [age 60 or older] with primary hyperparathyroidism, preservation of kidney function should not be a primary consideration when making decisions about whether to undergo parathyroidectomy,” lead author Carolyn D. Seib, MD, told this news organization.

“It is important that physicians also discuss with their patients the potential long-term benefits of parathyroidectomy related to a reduced risk of fractures, kidney stones, and cardiovascular disease, and improved quality of life, in addition to the need for lifelong surveillance if surgery is declined, weighing these against an individual patient’s risk of surgery,” said Dr. Seib, a surgeon at Palo Alto (Calif.) VA Medical Center.

“However, in patients younger than 60, early parathyroidectomy may prevent progression to chronic kidney disease (CKD) and should be more strongly considered,” she noted.

Parathyroidectomy, she observed, is a low-risk outpatient surgery for most adults.

“Potential complications of surgery include temporary or permanent hoarseness, hypoparathyroidism (low postoperative parathyroid function), bleeding requiring return to the operating room, and complications related to general anesthesia, all of which are rare,” said Dr. Seib.

“Surgery by a high-volume surgeon is associated with a reduced risk of complications, so patients should seek out an experienced parathyroid surgeon,” she emphasized.  

Moreover, parathyroidectomy is the only treatment for primary hyperparathyroidism.
 

Does parathyroidectomy slow loss of kidney function?

Multidisciplinary guidelines recommend parathyroidectomy, at least in part to mitigate the risk for, and effects related to, the progression of CKD in patients with PHPT and an eGFR below 60 mL/min per 1.73 m², the researchers wrote.

However, whether parathyroidectomy slows the loss of kidney function in adults with PHPT is not clear.

Guidelines also state that “observation for PHPT disease progression can be considered when patients have no obvious end organ damage (i.e., eGFR > 60 mL/min per 1.73 m², normal bone mineral density, and no history of kidney stones or fractures),” Dr. Seib noted.  

To address the evidence gap, the researchers emulated a randomized target trial using observational data.

In this type of study, Dr. Seib explained, “although patients aren’t randomly assigned to a treatment, complex statistical methods are used to adjust for baseline confounders in an attempt to emulate random treatment assignment and account for bias that may affect the timing of when patients receive treatment.”

Using national Veterans Health Administration data, researchers identified 43,697 veterans with a new biochemical diagnosis of PHPT, defined as elevated parathyroid hormone (> 65 ng/mL) within 6 months of an elevated serum calcium level (> 32.55 mmol/L or >10.2 mg/dL), from 2000 to 2019.

Of these patients, 3,804 underwent parathyroidectomy within 1 year of diagnosis of PHPT, and 39,893 did not, and instead, a watchful waiting approach was adopted.

To be included in the analysis, patients had to have an eGFR above 30 mL/min per 1.73 m² for 12 months before PHPT diagnosis to exclude secondary or tertiary hyperparathyroidism.

The primary outcome was a sustained decline in eGFR of at least 50% from baseline.

In the overall cohort, patients had a mean pretreatment eGFR of 71.8 mL/min per 1.73 m². The mean age of patients was 67, 88% were men, and 68% were White.

After a median follow-up of 4.9 years, 6.7% of the patients had a decline in eGFR of at least 50%.

The cumulative incidence of this decline in eGFR was 5.1% at 5 years and 10.8% at 10 years in patients who had had early parathyroidectomy compared with 5.1% and 12.0%, respectively, in patients who did not undergo surgery.

In the overall population, the risk of at least a 50% decline in eGFR was similar in the early parathyroidectomy group versus the observation group (adjusted hazard ratio [HR], 0.98, 95% confidence interval [CI], 0.82-1.16).

However, diving deeper showed that parathyroidectomy was associated with a reduced risk of the primary outcome among patients younger than 60 years (adjusted HR, 0.75, 95% CI, 0.59-0.93) but not among those aged 60 or older (adjusted HR, 1.08, 95% CI, 0.87-1.34).

“When participating in shared decision-making for older adults [age 60 and older] with PHPT, clinicians should not consider parathyroidectomy for potential benefits of preservation of kidney function,” the researchers reiterated.

“For younger patients, clinicians should discuss the potential benefit of parathyroidectomy to reduce the risk for CKD and associated complications in adults with PHPT,” they concluded.

The study was funded by the National Institute on Aging. The authors reported no relevant financial relationships.

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

Case: “Where’s my mommy?”

A 13-year-old girl “D” appeared lifeless in her hospital bed, swallowed by tubes, gauze, and crisp white sheets. She seemed fragile next to the giant machines beeping all around her, as they churned and groaned to keep her alive. She was in the pediatric intensive care unit, a place she had only seen once or twice on TV. Her sleeping mother lay next to her in an uncomfortable-looking recliner chair, curled up in a ball. She abruptly woke up when I walked into the room, doing her best to wipe away 5 days’ worth of worry and sadness from her exhausted face. She saw “Child Psychiatrist” written on my hospital badge, desperately searching my face for answers or a sign of hope.

Her daughter – a straight-A middle school student who loved Taylor Swift and soccer – had overdosed on Tylenol after discovering that she did not make the cheerleading team. I reported that her daughter’s liver enzymes were finally trending down and that she would likely not require a liver transplant. She would survive. As tears welled up in this mother’s eyes, I heard a faint whisper from across the room. “Where’s my mommy?” D was awake and frantically searching the room for her mother, someone who could soothe her in this living nightmare. As the two embraced, I felt tears well up in my eyes as I couldn’t help but think of my own 3-year-old daughter at home. How could I protect her from the sadness and despair that this little girl was feeling? How can we collectively protect every little girl from wanting to end their life?

CDC data: Teen girls need help now

The latest biennial Centers for Disease Control and Prevention Youth Risk Behavior Survey, administered in the fall of 2021, resulted in alarming data showing that mental health has worsened for all adolescents, but especially for girls. The survey was administered to more than 17,000 students in 152 public and private schools throughout the United States, showing that “America’s teen girls are engulfed in a growing wave of sadness, violence, and trauma.”¹ In particular, rates of sadness, suicidal ideation, suicide attempts, and mental health crisis ED visits among girls are the highest reported in a decade. Nearly 60% of girls felt persistent sadness or hopelessness during the past year, double the rate of boys. More than 25% of girls made a suicide plan; this percentage increased 60% over the past 10 years. Alarmingly, ED visits for suicide attempts for girls increased more than 50% in the past 2 years alone.

Even before the COVID-19 pandemic, experts were sounding the alarm on the growing rates of anxiety and depression in U.S. youth. The pandemic-driven isolation, lack of social connection, and missing of major milestones did not help the situation and only deepened the cracks in a faulty mental health care system. Further, civil unrest and social upheaval in the United States felt – and continues to feel – chaotic and unpredictable. For teens, the current cultural climate represents their not-too-distant future as adults, causing worry and anxiety.

In addition to securing their futures through performance in school and extracurricular activities, teenagers are forming their identities. Establishing a personal identity is a difficult task for all teens, though teenage girls face uniquely difficult challenges in our current society. In particular, teenage girls are expected to conform their behaviors to fit societal expectations that may clash with their desires and self-conceptualization. This conflict is further complicated by heightened beauty standards, online hate and competition, academic pressure, and self-doubt. CDC data show that girls experience sexual harassment and cyberbullying at roughly twice the rate of their male counterparts. Girls also experience higher levels of sexual violence and bullying. Alarmingly, 14% of girls reported being forced to have sex at some point in their lives. The sad truth is that, for every 10 teenage girls you know, at least one of them, and probably more, has likely been raped.
 

A call to action for providers

As providers, what can we do about these alarming statistics? It’s easy to become overwhelmed by data on a national level. However, regardless of our current clinical practice situation, we cannot lose sight of the humanity behind these numbers. Five extra minutes of truly listening to our patients, normalizing conversations about mental health, and looking for mental health warning signs (that is, increased isolation, declining function in school, maladaptive coping skills such as self-injurious behavior or substance use) can mean the difference between life and death.

As pediatric providers, formally screening for suicide risk is critical. Specifically, the American Academy of Pediatrics recommends that all youth aged 12 years or older be screened for suicide risk.² In addition to asking families to reduce access to lethal means, it is important to utilize suicide-specific screeners to prevent suicide attempts and deaths in the pediatric community. Pediatric providers must feel prepared to counsel patients and families on suicide prevention and, if this skill set is underdeveloped, appropriate referrals and support must be provided.

At the same time, it is important to note the larger context. This national tragedy has been long-standing and further accelerated by the social isolation and stress of the pandemic. Madigan and colleagues recently showed that the lack of a social outlet resulting from COVID-19 caused an increase in screen time among all children.³ As a result, many teen girls turned to social media to recreate these social connections online.⁴ This dependence on social media for validation has contributed to increased rates of depression by intensifying unrealistic body standards, comparisons, and competition among peers.⁵ However, recent pediatric partnership programs have improved mental health access, reduced ED visits, and increased primary care physician’s comfort with managing mental health concerns.⁶ These programs are called Child Psychiatry Access Programs (CPAPs) and utilize a collaborative care model through which primary care clinicians consult with child and adolescent psychiatrists. CPAPs, while not the entire solution, offer a major step in the right direction toward tackling this mental health crisis in a sustainable, collaborative, and effective way.

As students return to in-person learning, connectedness at school is a powerful protective factor against depression and anxiety. We must infuse resources and support into our schools and teachers, as they stand on the front lines for our children. Specifically, bolstering schools with school counselors and appropriate mental health support staff will help rescue teachers from burnout while also explicitly identifying mental health care as a priority. Finally, modeling positive behavior for families and identifying safe adults at school can help at-risk youth feel more connected. To achieve meaningful improvement in children’s mental health, it is crucial to collaboratively remodel broken systems to ensure that all children are supported early, effectively, and equitably.

Dr. Richards is assistant clinical professor in the department of psychiatry and biobehavioral sciences, program director of the child and adolescent psychiatry fellowship, and associate medical director of the perinatal program at the UCLA Semel Institute for Neuroscience and Human Behavior in Los Angeles.
 

References

1. Centers for Disease Control and Prevention. YRBSS Data Summary & Trends. 2023 Feb 13. https://www.cdc.gov/healthyyouth/data/yrbs/yrbs_data_summary_and_trends.htm

2. American Academy of Pediatrics. Screening for Suicide Risk in Clinical Practice. 2023 Feb 22. https://www.aap.org/en/patient-care/blueprint-for-youth-suicide-prevention/strategies-for-clinical-settings-for-youth-suicide-prevention/screening-for-suicide-risk-in-clinical-practice/

3. Madigan S et al. JAMA Pediatr. 2022;176(12):1188-98. doi: 10.1001/JAMAPEDIATRICS.2022.4116

4. Pew Research Center. Teens, Social Media and Technology 2022. 2022 Aug 10. https://www.pewresearch.org/internet/2022/08/10/teens-social-media-and-technology-2022/

5. Hunt MG et al. J Social Clin Psychology. 2018;37(10):751-68. doi: 10.1521/JSCP.2018.37.10.751

6. Godoy L et al. J Pediatr Health Care. 2022 Dec 16. doi: 10.1016/j.pedhc.2022.11.009.

Case: “Where’s my mommy?”

A 13-year-old girl “D” appeared lifeless in her hospital bed, swallowed by tubes, gauze, and crisp white sheets. She seemed fragile next to the giant machines beeping all around her, as they churned and groaned to keep her alive. She was in the pediatric intensive care unit, a place she had only seen once or twice on TV. Her sleeping mother lay next to her in an uncomfortable-looking recliner chair, curled up in a ball. She abruptly woke up when I walked into the room, doing her best to wipe away 5 days’ worth of worry and sadness from her exhausted face. She saw “Child Psychiatrist” written on my hospital badge, desperately searching my face for answers or a sign of hope.

Her daughter – a straight-A middle school student who loved Taylor Swift and soccer – had overdosed on Tylenol after discovering that she did not make the cheerleading team. I reported that her daughter’s liver enzymes were finally trending down and that she would likely not require a liver transplant. She would survive. As tears welled up in this mother’s eyes, I heard a faint whisper from across the room. “Where’s my mommy?” D was awake and frantically searching the room for her mother, someone who could soothe her in this living nightmare. As the two embraced, I felt tears well up in my eyes as I couldn’t help but think of my own 3-year-old daughter at home. How could I protect her from the sadness and despair that this little girl was feeling? How can we collectively protect every little girl from wanting to end their life?

CDC data: Teen girls need help now

The latest biennial Centers for Disease Control and Prevention Youth Risk Behavior Survey, administered in the fall of 2021, resulted in alarming data showing that mental health has worsened for all adolescents, but especially for girls. The survey was administered to more than 17,000 students in 152 public and private schools throughout the United States, showing that “America’s teen girls are engulfed in a growing wave of sadness, violence, and trauma.”¹ In particular, rates of sadness, suicidal ideation, suicide attempts, and mental health crisis ED visits among girls are the highest reported in a decade. Nearly 60% of girls felt persistent sadness or hopelessness during the past year, double the rate of boys. More than 25% of girls made a suicide plan; this percentage increased 60% over the past 10 years. Alarmingly, ED visits for suicide attempts for girls increased more than 50% in the past 2 years alone.

Even before the COVID-19 pandemic, experts were sounding the alarm on the growing rates of anxiety and depression in U.S. youth. The pandemic-driven isolation, lack of social connection, and missing of major milestones did not help the situation and only deepened the cracks in a faulty mental health care system. Further, civil unrest and social upheaval in the United States felt – and continues to feel – chaotic and unpredictable. For teens, the current cultural climate represents their not-too-distant future as adults, causing worry and anxiety.

In addition to securing their futures through performance in school and extracurricular activities, teenagers are forming their identities. Establishing a personal identity is a difficult task for all teens, though teenage girls face uniquely difficult challenges in our current society. In particular, teenage girls are expected to conform their behaviors to fit societal expectations that may clash with their desires and self-conceptualization. This conflict is further complicated by heightened beauty standards, online hate and competition, academic pressure, and self-doubt. CDC data show that girls experience sexual harassment and cyberbullying at roughly twice the rate of their male counterparts. Girls also experience higher levels of sexual violence and bullying. Alarmingly, 14% of girls reported being forced to have sex at some point in their lives. The sad truth is that, for every 10 teenage girls you know, at least one of them, and probably more, has likely been raped.
 

A call to action for providers

As providers, what can we do about these alarming statistics? It’s easy to become overwhelmed by data on a national level. However, regardless of our current clinical practice situation, we cannot lose sight of the humanity behind these numbers. Five extra minutes of truly listening to our patients, normalizing conversations about mental health, and looking for mental health warning signs (that is, increased isolation, declining function in school, maladaptive coping skills such as self-injurious behavior or substance use) can mean the difference between life and death.

As pediatric providers, formally screening for suicide risk is critical. Specifically, the American Academy of Pediatrics recommends that all youth aged 12 years or older be screened for suicide risk.² In addition to asking families to reduce access to lethal means, it is important to utilize suicide-specific screeners to prevent suicide attempts and deaths in the pediatric community. Pediatric providers must feel prepared to counsel patients and families on suicide prevention and, if this skill set is underdeveloped, appropriate referrals and support must be provided.

At the same time, it is important to note the larger context. This national tragedy has been long-standing and further accelerated by the social isolation and stress of the pandemic. Madigan and colleagues recently showed that the lack of a social outlet resulting from COVID-19 caused an increase in screen time among all children.³ As a result, many teen girls turned to social media to recreate these social connections online.⁴ This dependence on social media for validation has contributed to increased rates of depression by intensifying unrealistic body standards, comparisons, and competition among peers.⁵ However, recent pediatric partnership programs have improved mental health access, reduced ED visits, and increased primary care physician’s comfort with managing mental health concerns.⁶ These programs are called Child Psychiatry Access Programs (CPAPs) and utilize a collaborative care model through which primary care clinicians consult with child and adolescent psychiatrists. CPAPs, while not the entire solution, offer a major step in the right direction toward tackling this mental health crisis in a sustainable, collaborative, and effective way.

As students return to in-person learning, connectedness at school is a powerful protective factor against depression and anxiety. We must infuse resources and support into our schools and teachers, as they stand on the front lines for our children. Specifically, bolstering schools with school counselors and appropriate mental health support staff will help rescue teachers from burnout while also explicitly identifying mental health care as a priority. Finally, modeling positive behavior for families and identifying safe adults at school can help at-risk youth feel more connected. To achieve meaningful improvement in children’s mental health, it is crucial to collaboratively remodel broken systems to ensure that all children are supported early, effectively, and equitably.

Dr. Richards is assistant clinical professor in the department of psychiatry and biobehavioral sciences, program director of the child and adolescent psychiatry fellowship, and associate medical director of the perinatal program at the UCLA Semel Institute for Neuroscience and Human Behavior in Los Angeles.
 

References

1. Centers for Disease Control and Prevention. YRBSS Data Summary & Trends. 2023 Feb 13. https://www.cdc.gov/healthyyouth/data/yrbs/yrbs_data_summary_and_trends.htm

2. American Academy of Pediatrics. Screening for Suicide Risk in Clinical Practice. 2023 Feb 22. https://www.aap.org/en/patient-care/blueprint-for-youth-suicide-prevention/strategies-for-clinical-settings-for-youth-suicide-prevention/screening-for-suicide-risk-in-clinical-practice/

3. Madigan S et al. JAMA Pediatr. 2022;176(12):1188-98. doi: 10.1001/JAMAPEDIATRICS.2022.4116

4. Pew Research Center. Teens, Social Media and Technology 2022. 2022 Aug 10. https://www.pewresearch.org/internet/2022/08/10/teens-social-media-and-technology-2022/

5. Hunt MG et al. J Social Clin Psychology. 2018;37(10):751-68. doi: 10.1521/JSCP.2018.37.10.751

6. Godoy L et al. J Pediatr Health Care. 2022 Dec 16. doi: 10.1016/j.pedhc.2022.11.009.

Case: “Where’s my mommy?”

A 13-year-old girl “D” appeared lifeless in her hospital bed, swallowed by tubes, gauze, and crisp white sheets. She seemed fragile next to the giant machines beeping all around her, as they churned and groaned to keep her alive. She was in the pediatric intensive care unit, a place she had only seen once or twice on TV. Her sleeping mother lay next to her in an uncomfortable-looking recliner chair, curled up in a ball. She abruptly woke up when I walked into the room, doing her best to wipe away 5 days’ worth of worry and sadness from her exhausted face. She saw “Child Psychiatrist” written on my hospital badge, desperately searching my face for answers or a sign of hope.

Her daughter – a straight-A middle school student who loved Taylor Swift and soccer – had overdosed on Tylenol after discovering that she did not make the cheerleading team. I reported that her daughter’s liver enzymes were finally trending down and that she would likely not require a liver transplant. She would survive. As tears welled up in this mother’s eyes, I heard a faint whisper from across the room. “Where’s my mommy?” D was awake and frantically searching the room for her mother, someone who could soothe her in this living nightmare. As the two embraced, I felt tears well up in my eyes as I couldn’t help but think of my own 3-year-old daughter at home. How could I protect her from the sadness and despair that this little girl was feeling? How can we collectively protect every little girl from wanting to end their life?

CDC data: Teen girls need help now

The latest biennial Centers for Disease Control and Prevention Youth Risk Behavior Survey, administered in the fall of 2021, resulted in alarming data showing that mental health has worsened for all adolescents, but especially for girls. The survey was administered to more than 17,000 students in 152 public and private schools throughout the United States, showing that “America’s teen girls are engulfed in a growing wave of sadness, violence, and trauma.”¹ In particular, rates of sadness, suicidal ideation, suicide attempts, and mental health crisis ED visits among girls are the highest reported in a decade. Nearly 60% of girls felt persistent sadness or hopelessness during the past year, double the rate of boys. More than 25% of girls made a suicide plan; this percentage increased 60% over the past 10 years. Alarmingly, ED visits for suicide attempts for girls increased more than 50% in the past 2 years alone.

Even before the COVID-19 pandemic, experts were sounding the alarm on the growing rates of anxiety and depression in U.S. youth. The pandemic-driven isolation, lack of social connection, and missing of major milestones did not help the situation and only deepened the cracks in a faulty mental health care system. Further, civil unrest and social upheaval in the United States felt – and continues to feel – chaotic and unpredictable. For teens, the current cultural climate represents their not-too-distant future as adults, causing worry and anxiety.

In addition to securing their futures through performance in school and extracurricular activities, teenagers are forming their identities. Establishing a personal identity is a difficult task for all teens, though teenage girls face uniquely difficult challenges in our current society. In particular, teenage girls are expected to conform their behaviors to fit societal expectations that may clash with their desires and self-conceptualization. This conflict is further complicated by heightened beauty standards, online hate and competition, academic pressure, and self-doubt. CDC data show that girls experience sexual harassment and cyberbullying at roughly twice the rate of their male counterparts. Girls also experience higher levels of sexual violence and bullying. Alarmingly, 14% of girls reported being forced to have sex at some point in their lives. The sad truth is that, for every 10 teenage girls you know, at least one of them, and probably more, has likely been raped.
 

A call to action for providers

As providers, what can we do about these alarming statistics? It’s easy to become overwhelmed by data on a national level. However, regardless of our current clinical practice situation, we cannot lose sight of the humanity behind these numbers. Five extra minutes of truly listening to our patients, normalizing conversations about mental health, and looking for mental health warning signs (that is, increased isolation, declining function in school, maladaptive coping skills such as self-injurious behavior or substance use) can mean the difference between life and death.

As pediatric providers, formally screening for suicide risk is critical. Specifically, the American Academy of Pediatrics recommends that all youth aged 12 years or older be screened for suicide risk.² In addition to asking families to reduce access to lethal means, it is important to utilize suicide-specific screeners to prevent suicide attempts and deaths in the pediatric community. Pediatric providers must feel prepared to counsel patients and families on suicide prevention and, if this skill set is underdeveloped, appropriate referrals and support must be provided.

At the same time, it is important to note the larger context. This national tragedy has been long-standing and further accelerated by the social isolation and stress of the pandemic. Madigan and colleagues recently showed that the lack of a social outlet resulting from COVID-19 caused an increase in screen time among all children.³ As a result, many teen girls turned to social media to recreate these social connections online.⁴ This dependence on social media for validation has contributed to increased rates of depression by intensifying unrealistic body standards, comparisons, and competition among peers.⁵ However, recent pediatric partnership programs have improved mental health access, reduced ED visits, and increased primary care physician’s comfort with managing mental health concerns.⁶ These programs are called Child Psychiatry Access Programs (CPAPs) and utilize a collaborative care model through which primary care clinicians consult with child and adolescent psychiatrists. CPAPs, while not the entire solution, offer a major step in the right direction toward tackling this mental health crisis in a sustainable, collaborative, and effective way.

As students return to in-person learning, connectedness at school is a powerful protective factor against depression and anxiety. We must infuse resources and support into our schools and teachers, as they stand on the front lines for our children. Specifically, bolstering schools with school counselors and appropriate mental health support staff will help rescue teachers from burnout while also explicitly identifying mental health care as a priority. Finally, modeling positive behavior for families and identifying safe adults at school can help at-risk youth feel more connected. To achieve meaningful improvement in children’s mental health, it is crucial to collaboratively remodel broken systems to ensure that all children are supported early, effectively, and equitably.

Dr. Richards is assistant clinical professor in the department of psychiatry and biobehavioral sciences, program director of the child and adolescent psychiatry fellowship, and associate medical director of the perinatal program at the UCLA Semel Institute for Neuroscience and Human Behavior in Los Angeles.
 

References

1. Centers for Disease Control and Prevention. YRBSS Data Summary & Trends. 2023 Feb 13. https://www.cdc.gov/healthyyouth/data/yrbs/yrbs_data_summary_and_trends.htm

2. American Academy of Pediatrics. Screening for Suicide Risk in Clinical Practice. 2023 Feb 22. https://www.aap.org/en/patient-care/blueprint-for-youth-suicide-prevention/strategies-for-clinical-settings-for-youth-suicide-prevention/screening-for-suicide-risk-in-clinical-practice/

3. Madigan S et al. JAMA Pediatr. 2022;176(12):1188-98. doi: 10.1001/JAMAPEDIATRICS.2022.4116

4. Pew Research Center. Teens, Social Media and Technology 2022. 2022 Aug 10. https://www.pewresearch.org/internet/2022/08/10/teens-social-media-and-technology-2022/

5. Hunt MG et al. J Social Clin Psychology. 2018;37(10):751-68. doi: 10.1521/JSCP.2018.37.10.751

6. Godoy L et al. J Pediatr Health Care. 2022 Dec 16. doi: 10.1016/j.pedhc.2022.11.009.

The number of sentinel events in hospitals in the United States increased by 19% from 2021 to 2022, on the basis of new data from The Joint Commission.

Reporting sentinel events to The Joint Commission began in 1996 as a way to help health care organizations improve safety. The annual review is based on an aggregate database of reports analyzed each year, according to the review authors.

The Joint Commission defines a sentinel event as a patient safety event (not primarily related to the natural course of the patient’s illness or underlying condition) that reaches a patient and results in death, permanent harm (regardless of severity), or severe harm (regardless of duration).

Some of the specific events deemed sentinel include patient suicide while under care in a health care setting, unanticipated death of a full-term infant, homicide of any patient or staff member while on site at a health care organization, any intrapartum maternal death, severe maternal morbidity, sexual abuse or assault of any patient undergoing care in the health care setting, sexual abuse or assault of any staff member providing care, and physical assault of any patient or staff member in the health care setting.

Additional events considered sentinel are related to treatments and procedures. These include surgery in the wrong site; wrong patient or wrong procedure for a given patient; administration of blood or blood products incompatible with the patient that results in death, permanent harm, or severe harm; severe neonatal hyperbilirubinemia; and patient falls.

A total of 1,441 sentinel events were reported in 2022. Patient falls accounted for the majority (42%) of these events, continuing a trend in increasing rates of patient falls from previous years. Falls considered sentinel events were those resulting in any fracture, surgery, casting or traction, consultation or comfort care for neurologic or internal injury, the need for blood products, or death or permanent harm as a result of injuries sustained in the fall. The leading sentinel event types after falls included delay in treatment, unintended retention of a foreign object, and wrong surgery (6% for each). Other sentinel event types in the top 10 accounted for 5% or less of reports: suicide (5%), assault/rape/sexual assault/homicide (4%), fire/burns (3%), perinatal events (2%), self-harm (2%), and medication management (2%).

Overall, 20% of the 2022 events resulted in patient death, 6% in permanent harm or loss of function, 44% in severe temporary harm, and 13% in a need for additional care or an extended hospital stay.

The most common events that led to patient death were suicide (24%), treatment delays (21%), and patient falls (11%). Patient falls also accounted for nearly two-thirds of the events resulting in severe temporary harm (62%).

Most of the events (88%) occurred in hospital settings; of these, the most common were falls (45%), followed by the retention of foreign objects and incorrect surgeries (7% and 6%, respectively). Overall, 90% of sentinel events were reported by the health care organizations; the remaining 10% were reported by patients, families, or employees (current or former).

“Failures in communication, teamwork, and consistently following policies were leading causes for reported sentinel events,” the authors wrote. However, reporting sentinel events is voluntary; therefore “no conclusions should be drawn about the actual relative frequency of events or trends in events over time,” they noted.
 

Increased reporting may not reflect increased occurrence

“It is important to clarify that The Joint Commission saw an increase in reporting of sentinel events; whether this is indicative of an actual increase in occurrence of sentinel events across the country or not is difficult to say, as the reporting is voluntary,” said Haytham Kaafarani, MD, MPH, chief patient safety officer and medical director for The Joint Commission, in an interview.

“However, this is the highest number reported to The Joint Commission since the inception of the sentinel event policy: there were 547 health care organizations that reported sentinel events in 2022, compared to 500 in 2021 and 423 in 2020,” Dr. Kaafarani said. “Having said that, based on published literature, the COVID-19 pandemic stressed our health care systems in many ways including but not limited to staff shortage in times of increased needs, worsening of mental health conditions, and delay in presentation of non–COVID-related medical conditions during the pandemic,” he noted.

Dr. Kaafarani said that The Joint Commission was not surprised by the type of sentinel events reported, which has remained consistent with previous years.

However, The Joint Commission was surprised by the significant increase in the number of reported events, he said. “Since reporting is voluntarily, we welcome the increase in reporting of sentinel events, as it helps The Joint Commission better understand the patient safety landscape across the country, and better helps health care organizations during their difficult times.”

Based on the latest information, “The Joint Commission encourages health care organizations to create research that is focused on preventing patient falls in hospitals,” said Dr. Kaafarani. “With staff shortages reported within many health care organizations, it is now more essential than ever to establish systematic interventions to prevent patient falls and resultant harm.”

The review authors report no relevant financial relationships.

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

The number of sentinel events in hospitals in the United States increased by 19% from 2021 to 2022, on the basis of new data from The Joint Commission.

Reporting sentinel events to The Joint Commission began in 1996 as a way to help health care organizations improve safety. The annual review is based on an aggregate database of reports analyzed each year, according to the review authors.

The Joint Commission defines a sentinel event as a patient safety event (not primarily related to the natural course of the patient’s illness or underlying condition) that reaches a patient and results in death, permanent harm (regardless of severity), or severe harm (regardless of duration).

Some of the specific events deemed sentinel include patient suicide while under care in a health care setting, unanticipated death of a full-term infant, homicide of any patient or staff member while on site at a health care organization, any intrapartum maternal death, severe maternal morbidity, sexual abuse or assault of any patient undergoing care in the health care setting, sexual abuse or assault of any staff member providing care, and physical assault of any patient or staff member in the health care setting.

Additional events considered sentinel are related to treatments and procedures. These include surgery in the wrong site; wrong patient or wrong procedure for a given patient; administration of blood or blood products incompatible with the patient that results in death, permanent harm, or severe harm; severe neonatal hyperbilirubinemia; and patient falls.

A total of 1,441 sentinel events were reported in 2022. Patient falls accounted for the majority (42%) of these events, continuing a trend in increasing rates of patient falls from previous years. Falls considered sentinel events were those resulting in any fracture, surgery, casting or traction, consultation or comfort care for neurologic or internal injury, the need for blood products, or death or permanent harm as a result of injuries sustained in the fall. The leading sentinel event types after falls included delay in treatment, unintended retention of a foreign object, and wrong surgery (6% for each). Other sentinel event types in the top 10 accounted for 5% or less of reports: suicide (5%), assault/rape/sexual assault/homicide (4%), fire/burns (3%), perinatal events (2%), self-harm (2%), and medication management (2%).

Overall, 20% of the 2022 events resulted in patient death, 6% in permanent harm or loss of function, 44% in severe temporary harm, and 13% in a need for additional care or an extended hospital stay.

The most common events that led to patient death were suicide (24%), treatment delays (21%), and patient falls (11%). Patient falls also accounted for nearly two-thirds of the events resulting in severe temporary harm (62%).

Most of the events (88%) occurred in hospital settings; of these, the most common were falls (45%), followed by the retention of foreign objects and incorrect surgeries (7% and 6%, respectively). Overall, 90% of sentinel events were reported by the health care organizations; the remaining 10% were reported by patients, families, or employees (current or former).

“Failures in communication, teamwork, and consistently following policies were leading causes for reported sentinel events,” the authors wrote. However, reporting sentinel events is voluntary; therefore “no conclusions should be drawn about the actual relative frequency of events or trends in events over time,” they noted.
 

Increased reporting may not reflect increased occurrence

“It is important to clarify that The Joint Commission saw an increase in reporting of sentinel events; whether this is indicative of an actual increase in occurrence of sentinel events across the country or not is difficult to say, as the reporting is voluntary,” said Haytham Kaafarani, MD, MPH, chief patient safety officer and medical director for The Joint Commission, in an interview.

“However, this is the highest number reported to The Joint Commission since the inception of the sentinel event policy: there were 547 health care organizations that reported sentinel events in 2022, compared to 500 in 2021 and 423 in 2020,” Dr. Kaafarani said. “Having said that, based on published literature, the COVID-19 pandemic stressed our health care systems in many ways including but not limited to staff shortage in times of increased needs, worsening of mental health conditions, and delay in presentation of non–COVID-related medical conditions during the pandemic,” he noted.

Dr. Kaafarani said that The Joint Commission was not surprised by the type of sentinel events reported, which has remained consistent with previous years.

However, The Joint Commission was surprised by the significant increase in the number of reported events, he said. “Since reporting is voluntarily, we welcome the increase in reporting of sentinel events, as it helps The Joint Commission better understand the patient safety landscape across the country, and better helps health care organizations during their difficult times.”

Based on the latest information, “The Joint Commission encourages health care organizations to create research that is focused on preventing patient falls in hospitals,” said Dr. Kaafarani. “With staff shortages reported within many health care organizations, it is now more essential than ever to establish systematic interventions to prevent patient falls and resultant harm.”

The review authors report no relevant financial relationships.

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

The number of sentinel events in hospitals in the United States increased by 19% from 2021 to 2022, on the basis of new data from The Joint Commission.

Reporting sentinel events to The Joint Commission began in 1996 as a way to help health care organizations improve safety. The annual review is based on an aggregate database of reports analyzed each year, according to the review authors.

The Joint Commission defines a sentinel event as a patient safety event (not primarily related to the natural course of the patient’s illness or underlying condition) that reaches a patient and results in death, permanent harm (regardless of severity), or severe harm (regardless of duration).

Some of the specific events deemed sentinel include patient suicide while under care in a health care setting, unanticipated death of a full-term infant, homicide of any patient or staff member while on site at a health care organization, any intrapartum maternal death, severe maternal morbidity, sexual abuse or assault of any patient undergoing care in the health care setting, sexual abuse or assault of any staff member providing care, and physical assault of any patient or staff member in the health care setting.

Additional events considered sentinel are related to treatments and procedures. These include surgery in the wrong site; wrong patient or wrong procedure for a given patient; administration of blood or blood products incompatible with the patient that results in death, permanent harm, or severe harm; severe neonatal hyperbilirubinemia; and patient falls.

A total of 1,441 sentinel events were reported in 2022. Patient falls accounted for the majority (42%) of these events, continuing a trend in increasing rates of patient falls from previous years. Falls considered sentinel events were those resulting in any fracture, surgery, casting or traction, consultation or comfort care for neurologic or internal injury, the need for blood products, or death or permanent harm as a result of injuries sustained in the fall. The leading sentinel event types after falls included delay in treatment, unintended retention of a foreign object, and wrong surgery (6% for each). Other sentinel event types in the top 10 accounted for 5% or less of reports: suicide (5%), assault/rape/sexual assault/homicide (4%), fire/burns (3%), perinatal events (2%), self-harm (2%), and medication management (2%).

Overall, 20% of the 2022 events resulted in patient death, 6% in permanent harm or loss of function, 44% in severe temporary harm, and 13% in a need for additional care or an extended hospital stay.

The most common events that led to patient death were suicide (24%), treatment delays (21%), and patient falls (11%). Patient falls also accounted for nearly two-thirds of the events resulting in severe temporary harm (62%).

Most of the events (88%) occurred in hospital settings; of these, the most common were falls (45%), followed by the retention of foreign objects and incorrect surgeries (7% and 6%, respectively). Overall, 90% of sentinel events were reported by the health care organizations; the remaining 10% were reported by patients, families, or employees (current or former).

“Failures in communication, teamwork, and consistently following policies were leading causes for reported sentinel events,” the authors wrote. However, reporting sentinel events is voluntary; therefore “no conclusions should be drawn about the actual relative frequency of events or trends in events over time,” they noted.
 

Increased reporting may not reflect increased occurrence

“It is important to clarify that The Joint Commission saw an increase in reporting of sentinel events; whether this is indicative of an actual increase in occurrence of sentinel events across the country or not is difficult to say, as the reporting is voluntary,” said Haytham Kaafarani, MD, MPH, chief patient safety officer and medical director for The Joint Commission, in an interview.

“However, this is the highest number reported to The Joint Commission since the inception of the sentinel event policy: there were 547 health care organizations that reported sentinel events in 2022, compared to 500 in 2021 and 423 in 2020,” Dr. Kaafarani said. “Having said that, based on published literature, the COVID-19 pandemic stressed our health care systems in many ways including but not limited to staff shortage in times of increased needs, worsening of mental health conditions, and delay in presentation of non–COVID-related medical conditions during the pandemic,” he noted.

Dr. Kaafarani said that The Joint Commission was not surprised by the type of sentinel events reported, which has remained consistent with previous years.

However, The Joint Commission was surprised by the significant increase in the number of reported events, he said. “Since reporting is voluntarily, we welcome the increase in reporting of sentinel events, as it helps The Joint Commission better understand the patient safety landscape across the country, and better helps health care organizations during their difficult times.”

Based on the latest information, “The Joint Commission encourages health care organizations to create research that is focused on preventing patient falls in hospitals,” said Dr. Kaafarani. “With staff shortages reported within many health care organizations, it is now more essential than ever to establish systematic interventions to prevent patient falls and resultant harm.”

The review authors report no relevant financial relationships.

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

I imagine I am not alone when I tell you that my blood pressure rises every time I receive an email from CoverMyMeds, or worse, a phone call from a patient to tell me the pharmacist says I need to call their insurance company to get a medication authorized. Prior authorizations (PAs) are the bane of every physician’s existence.

Pharmacy benefit managers (PBMs) and insurers determine what treatment patients may have without regulation, accountability, liability, or transparency. They ask providers to jump through hoops, and no one oversees the placement of these hoops. The process puts patients at risk and sucks the joy from the practice of medicine.

In fall 2021, the legislative committee of the Maryland Psychiatric Society, with the help of Kathy Orellana and Tim Clement from the American Psychiatric Association, drafted a bill to modify the use of PAs. Unfortunately, the bill died in committee during the 2022 Maryland General Assembly legislative session.

Robert Herman, MD, who helped draft the initial legislation, was delighted when he learned that MedChi, the Maryland State Medical Society, had taken the proposed legislation and expanded it. “It was everything we wished for and more,” Dr. Herman said.

During this year’s legislative session, House Bill 305/Senate Bill 308, Health Insurance – Utilization Review – Revisions, was sponsored by 19 delegates and two senators. Fifty medical associations, including dentists and physical therapists, endorsed the bill. Many people, including Dr. Herman, testified before the Health and Government Operations Committee on Feb. 16.

Delegate Kenneth Kerr introduced the legislation to the committee.

“Before I begin, let me make two points. First, the bill does not do away with prior authorization or other utilization review techniques; rather, it tries to make a more balanced approach for both patients and physicians by attempting to reduce the volume that’s subject to prior authorization, by increasing transparency and communication, and by studying how the process can be improved overall. Second, we have over 50 organizations representing health care providers and patient advocacy organizations supporting this legislation. This is a systemic issue across the entire spectrum of healthcare,” said Mr. Kerr.

Mr. Kerr went on to say there were 81,143 denials for treatment in 2021. The three areas with the highest rate of denials were pharmacy, dental, and the combination of labs and radiology.

He further noted that, when consumers filed a complaint with the Maryland Insurance Administration, 72.4% of denials were reversed in 2022.

“This resulted in more benefits that could have, and should have, been given to the patient at the first request. These reversals indicate there is a problem,” Mr. Kerr said. He discussed increased administrative costs, the enormous workload burden this incurs, and the problem of burnout among medical providers.

The proposed legislation includes a ban on PA requirements for generic medications, for dose changes of previously authorized medication, and ends the requirement for yearly authorizations. It requires that a physician of the same specialty be on the panel that denies care and shortens the time periods allowed for responses and appeals.

Testimony began with those supporting the legislation. Doctors highlighted the harm inflicted on their patients by the PA process. An oncologist spoke of how it took weeks to get approval for chemotherapy for a patient with an aggressive cancer, a gastroenterologist discussed a patient who became ill and lost her job when successful treatment for inflammatory bowel disease was stopped while she waited for the yearly medication reapproval, and another physician told of a patient who died of an exacerbation of obstructive lung disease, also while awaiting a yearly reapproval for an effective medication.

A dentist spoke about how he was not authorized to place a crown on a patient’s tooth. Instead, he was instructed to try a filling first, and when the filling failed, he was told he would not be authorized to work on the same tooth twice in one year.

A physical therapist testified that PA was required every two to four sessions, and each request took up half of a session – a significant portion of time that was not used for treatment.

Three people testified in opposition to the bill. Matthew Celantano, executive director of the League of Life and Health Insurers of Maryland, called the legislation “drastic” and testified that the cost would be prohibitive.

“From our end, it’s important for you to hear that prior authorization is care coordination. It’s protection that keeps [patients] safe, but helps control skyrocketing health care costs,” said Mr. Celantano.

Deb Rivkin, vice president of government affairs for CareFirst Blue Cross Blue Shield, testified in favor of using better technology. She cited legislation under consideration in Virginia that would give clinicians more information about the specific medications that require PAs, price information, and real-time authorizations.

Finally, representing the Pharmaceutical Care Management Association, Heather Cascone testified about PAs for generic medications. Her testimony focused on prior authorization for generic medications. She claimed that “... by allowing unrestricted dispensing of generic drugs, or an override based on the subjective opinion of the prescriber, prior authorization can protect patients from drugs with a safety risk; they can catch things like drug-disease contraindications, dosage errors, pregnancy-related contraindications, and a variety of cost-savings protections.”

I found this testimony particularly difficult because the “protector” is generally not a physician and has neither seen, nor examined, the patient. The implication that patients need protection from their doctors who would be unaware aware that they are pregnant, or are ill, was offensive. It also implies that PBMs are lax by not requiring PA on all medications, ignoring the fact that patients often bypass such denials by paying out of pocket for treatment.

If this had been a high school debate, there would be no doubt the enthusiasm for the bill for HB305 was strong, the committee chair was eager, and the arguments in favor of the legislation robust. There are no public minutes for the subsequent meetings with stakeholders, and I was somewhat heartbroken to learn that once again, the bill died in committee.

Annette Hanson, MD, chair of the MPS legislative committee, remains optimistic for the future. “Since then, the APA [American Psychiatric Association] has taken our bill and used it as model legislation now being offered to other district branches. MPS has created something that is going to spread across the country. Change may be slow, but it is not inevitable. And when it happens, I want you to remember that it started here,” she said.

However, the pressure is on. A recent ProPublica article documented how Cigna rejects claims by the batch without ever reviewing them. Soon after that piece was published, it was announced that several of the large insurers, including Cigna, would be cutting back on PA demands. It remains to be seen whether this is a token move to placate legislators, and whether it will provide meaningful relief to physicians and patients. I remain skeptical.

In the meantime, physicians’ ability to help their patients remains compromised and administrative tasks consume valuable time. I have started to wonder whether there may be some other way to push this issue to action. PA is about cost containment, but perhaps there are other ways to economize.

Why do medications cost less in other countries? Why does a medication cost hundreds of dollars more at one pharmacy versus another? Why do medicines sometimes have a copay that is two or three times higher than the cash price? Why do some covered medications have copays of thousands of dollars a year? I wonder if physicians shouldn’t come together and collectively agree not to comply and refuse to complete PAs in organized rebellion.

The fear, of course, is that such an endeavor would hurt patients, but if we all agreed in concert, then for better or for worse, something would have to give. The existing system is already hurting everyone, and physicians, by agreeing to play this awful game, are complicit in letting insurers dictate the care our patients receive.

Dinah Miller, MD, is a coauthor of Committed: The Battle Over Involuntary Psychiatric Care (Johns Hopkins University Press, 2016) and has a private practice and is an assistant professor of psychiatry and behavioral sciences at Johns Hopkins in Baltimore.

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

I imagine I am not alone when I tell you that my blood pressure rises every time I receive an email from CoverMyMeds, or worse, a phone call from a patient to tell me the pharmacist says I need to call their insurance company to get a medication authorized. Prior authorizations (PAs) are the bane of every physician’s existence.

Pharmacy benefit managers (PBMs) and insurers determine what treatment patients may have without regulation, accountability, liability, or transparency. They ask providers to jump through hoops, and no one oversees the placement of these hoops. The process puts patients at risk and sucks the joy from the practice of medicine.

In fall 2021, the legislative committee of the Maryland Psychiatric Society, with the help of Kathy Orellana and Tim Clement from the American Psychiatric Association, drafted a bill to modify the use of PAs. Unfortunately, the bill died in committee during the 2022 Maryland General Assembly legislative session.

Robert Herman, MD, who helped draft the initial legislation, was delighted when he learned that MedChi, the Maryland State Medical Society, had taken the proposed legislation and expanded it. “It was everything we wished for and more,” Dr. Herman said.

During this year’s legislative session, House Bill 305/Senate Bill 308, Health Insurance – Utilization Review – Revisions, was sponsored by 19 delegates and two senators. Fifty medical associations, including dentists and physical therapists, endorsed the bill. Many people, including Dr. Herman, testified before the Health and Government Operations Committee on Feb. 16.

Delegate Kenneth Kerr introduced the legislation to the committee.

“Before I begin, let me make two points. First, the bill does not do away with prior authorization or other utilization review techniques; rather, it tries to make a more balanced approach for both patients and physicians by attempting to reduce the volume that’s subject to prior authorization, by increasing transparency and communication, and by studying how the process can be improved overall. Second, we have over 50 organizations representing health care providers and patient advocacy organizations supporting this legislation. This is a systemic issue across the entire spectrum of healthcare,” said Mr. Kerr.

Mr. Kerr went on to say there were 81,143 denials for treatment in 2021. The three areas with the highest rate of denials were pharmacy, dental, and the combination of labs and radiology.

He further noted that, when consumers filed a complaint with the Maryland Insurance Administration, 72.4% of denials were reversed in 2022.

“This resulted in more benefits that could have, and should have, been given to the patient at the first request. These reversals indicate there is a problem,” Mr. Kerr said. He discussed increased administrative costs, the enormous workload burden this incurs, and the problem of burnout among medical providers.

The proposed legislation includes a ban on PA requirements for generic medications, for dose changes of previously authorized medication, and ends the requirement for yearly authorizations. It requires that a physician of the same specialty be on the panel that denies care and shortens the time periods allowed for responses and appeals.

Testimony began with those supporting the legislation. Doctors highlighted the harm inflicted on their patients by the PA process. An oncologist spoke of how it took weeks to get approval for chemotherapy for a patient with an aggressive cancer, a gastroenterologist discussed a patient who became ill and lost her job when successful treatment for inflammatory bowel disease was stopped while she waited for the yearly medication reapproval, and another physician told of a patient who died of an exacerbation of obstructive lung disease, also while awaiting a yearly reapproval for an effective medication.

A dentist spoke about how he was not authorized to place a crown on a patient’s tooth. Instead, he was instructed to try a filling first, and when the filling failed, he was told he would not be authorized to work on the same tooth twice in one year.

A physical therapist testified that PA was required every two to four sessions, and each request took up half of a session – a significant portion of time that was not used for treatment.

Three people testified in opposition to the bill. Matthew Celantano, executive director of the League of Life and Health Insurers of Maryland, called the legislation “drastic” and testified that the cost would be prohibitive.

“From our end, it’s important for you to hear that prior authorization is care coordination. It’s protection that keeps [patients] safe, but helps control skyrocketing health care costs,” said Mr. Celantano.

Deb Rivkin, vice president of government affairs for CareFirst Blue Cross Blue Shield, testified in favor of using better technology. She cited legislation under consideration in Virginia that would give clinicians more information about the specific medications that require PAs, price information, and real-time authorizations.

Finally, representing the Pharmaceutical Care Management Association, Heather Cascone testified about PAs for generic medications. Her testimony focused on prior authorization for generic medications. She claimed that “... by allowing unrestricted dispensing of generic drugs, or an override based on the subjective opinion of the prescriber, prior authorization can protect patients from drugs with a safety risk; they can catch things like drug-disease contraindications, dosage errors, pregnancy-related contraindications, and a variety of cost-savings protections.”

I found this testimony particularly difficult because the “protector” is generally not a physician and has neither seen, nor examined, the patient. The implication that patients need protection from their doctors who would be unaware aware that they are pregnant, or are ill, was offensive. It also implies that PBMs are lax by not requiring PA on all medications, ignoring the fact that patients often bypass such denials by paying out of pocket for treatment.

If this had been a high school debate, there would be no doubt the enthusiasm for the bill for HB305 was strong, the committee chair was eager, and the arguments in favor of the legislation robust. There are no public minutes for the subsequent meetings with stakeholders, and I was somewhat heartbroken to learn that once again, the bill died in committee.

Annette Hanson, MD, chair of the MPS legislative committee, remains optimistic for the future. “Since then, the APA [American Psychiatric Association] has taken our bill and used it as model legislation now being offered to other district branches. MPS has created something that is going to spread across the country. Change may be slow, but it is not inevitable. And when it happens, I want you to remember that it started here,” she said.

However, the pressure is on. A recent ProPublica article documented how Cigna rejects claims by the batch without ever reviewing them. Soon after that piece was published, it was announced that several of the large insurers, including Cigna, would be cutting back on PA demands. It remains to be seen whether this is a token move to placate legislators, and whether it will provide meaningful relief to physicians and patients. I remain skeptical.

In the meantime, physicians’ ability to help their patients remains compromised and administrative tasks consume valuable time. I have started to wonder whether there may be some other way to push this issue to action. PA is about cost containment, but perhaps there are other ways to economize.

Why do medications cost less in other countries? Why does a medication cost hundreds of dollars more at one pharmacy versus another? Why do medicines sometimes have a copay that is two or three times higher than the cash price? Why do some covered medications have copays of thousands of dollars a year? I wonder if physicians shouldn’t come together and collectively agree not to comply and refuse to complete PAs in organized rebellion.

The fear, of course, is that such an endeavor would hurt patients, but if we all agreed in concert, then for better or for worse, something would have to give. The existing system is already hurting everyone, and physicians, by agreeing to play this awful game, are complicit in letting insurers dictate the care our patients receive.

Dinah Miller, MD, is a coauthor of Committed: The Battle Over Involuntary Psychiatric Care (Johns Hopkins University Press, 2016) and has a private practice and is an assistant professor of psychiatry and behavioral sciences at Johns Hopkins in Baltimore.

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

I imagine I am not alone when I tell you that my blood pressure rises every time I receive an email from CoverMyMeds, or worse, a phone call from a patient to tell me the pharmacist says I need to call their insurance company to get a medication authorized. Prior authorizations (PAs) are the bane of every physician’s existence.

Pharmacy benefit managers (PBMs) and insurers determine what treatment patients may have without regulation, accountability, liability, or transparency. They ask providers to jump through hoops, and no one oversees the placement of these hoops. The process puts patients at risk and sucks the joy from the practice of medicine.

In fall 2021, the legislative committee of the Maryland Psychiatric Society, with the help of Kathy Orellana and Tim Clement from the American Psychiatric Association, drafted a bill to modify the use of PAs. Unfortunately, the bill died in committee during the 2022 Maryland General Assembly legislative session.

Robert Herman, MD, who helped draft the initial legislation, was delighted when he learned that MedChi, the Maryland State Medical Society, had taken the proposed legislation and expanded it. “It was everything we wished for and more,” Dr. Herman said.

During this year’s legislative session, House Bill 305/Senate Bill 308, Health Insurance – Utilization Review – Revisions, was sponsored by 19 delegates and two senators. Fifty medical associations, including dentists and physical therapists, endorsed the bill. Many people, including Dr. Herman, testified before the Health and Government Operations Committee on Feb. 16.

Delegate Kenneth Kerr introduced the legislation to the committee.

“Before I begin, let me make two points. First, the bill does not do away with prior authorization or other utilization review techniques; rather, it tries to make a more balanced approach for both patients and physicians by attempting to reduce the volume that’s subject to prior authorization, by increasing transparency and communication, and by studying how the process can be improved overall. Second, we have over 50 organizations representing health care providers and patient advocacy organizations supporting this legislation. This is a systemic issue across the entire spectrum of healthcare,” said Mr. Kerr.

Mr. Kerr went on to say there were 81,143 denials for treatment in 2021. The three areas with the highest rate of denials were pharmacy, dental, and the combination of labs and radiology.

He further noted that, when consumers filed a complaint with the Maryland Insurance Administration, 72.4% of denials were reversed in 2022.

“This resulted in more benefits that could have, and should have, been given to the patient at the first request. These reversals indicate there is a problem,” Mr. Kerr said. He discussed increased administrative costs, the enormous workload burden this incurs, and the problem of burnout among medical providers.

The proposed legislation includes a ban on PA requirements for generic medications, for dose changes of previously authorized medication, and ends the requirement for yearly authorizations. It requires that a physician of the same specialty be on the panel that denies care and shortens the time periods allowed for responses and appeals.

Testimony began with those supporting the legislation. Doctors highlighted the harm inflicted on their patients by the PA process. An oncologist spoke of how it took weeks to get approval for chemotherapy for a patient with an aggressive cancer, a gastroenterologist discussed a patient who became ill and lost her job when successful treatment for inflammatory bowel disease was stopped while she waited for the yearly medication reapproval, and another physician told of a patient who died of an exacerbation of obstructive lung disease, also while awaiting a yearly reapproval for an effective medication.

A dentist spoke about how he was not authorized to place a crown on a patient’s tooth. Instead, he was instructed to try a filling first, and when the filling failed, he was told he would not be authorized to work on the same tooth twice in one year.

A physical therapist testified that PA was required every two to four sessions, and each request took up half of a session – a significant portion of time that was not used for treatment.

Three people testified in opposition to the bill. Matthew Celantano, executive director of the League of Life and Health Insurers of Maryland, called the legislation “drastic” and testified that the cost would be prohibitive.

“From our end, it’s important for you to hear that prior authorization is care coordination. It’s protection that keeps [patients] safe, but helps control skyrocketing health care costs,” said Mr. Celantano.

Deb Rivkin, vice president of government affairs for CareFirst Blue Cross Blue Shield, testified in favor of using better technology. She cited legislation under consideration in Virginia that would give clinicians more information about the specific medications that require PAs, price information, and real-time authorizations.

Finally, representing the Pharmaceutical Care Management Association, Heather Cascone testified about PAs for generic medications. Her testimony focused on prior authorization for generic medications. She claimed that “... by allowing unrestricted dispensing of generic drugs, or an override based on the subjective opinion of the prescriber, prior authorization can protect patients from drugs with a safety risk; they can catch things like drug-disease contraindications, dosage errors, pregnancy-related contraindications, and a variety of cost-savings protections.”

I found this testimony particularly difficult because the “protector” is generally not a physician and has neither seen, nor examined, the patient. The implication that patients need protection from their doctors who would be unaware aware that they are pregnant, or are ill, was offensive. It also implies that PBMs are lax by not requiring PA on all medications, ignoring the fact that patients often bypass such denials by paying out of pocket for treatment.

If this had been a high school debate, there would be no doubt the enthusiasm for the bill for HB305 was strong, the committee chair was eager, and the arguments in favor of the legislation robust. There are no public minutes for the subsequent meetings with stakeholders, and I was somewhat heartbroken to learn that once again, the bill died in committee.

Annette Hanson, MD, chair of the MPS legislative committee, remains optimistic for the future. “Since then, the APA [American Psychiatric Association] has taken our bill and used it as model legislation now being offered to other district branches. MPS has created something that is going to spread across the country. Change may be slow, but it is not inevitable. And when it happens, I want you to remember that it started here,” she said.

However, the pressure is on. A recent ProPublica article documented how Cigna rejects claims by the batch without ever reviewing them. Soon after that piece was published, it was announced that several of the large insurers, including Cigna, would be cutting back on PA demands. It remains to be seen whether this is a token move to placate legislators, and whether it will provide meaningful relief to physicians and patients. I remain skeptical.

In the meantime, physicians’ ability to help their patients remains compromised and administrative tasks consume valuable time. I have started to wonder whether there may be some other way to push this issue to action. PA is about cost containment, but perhaps there are other ways to economize.

Why do medications cost less in other countries? Why does a medication cost hundreds of dollars more at one pharmacy versus another? Why do medicines sometimes have a copay that is two or three times higher than the cash price? Why do some covered medications have copays of thousands of dollars a year? I wonder if physicians shouldn’t come together and collectively agree not to comply and refuse to complete PAs in organized rebellion.

The fear, of course, is that such an endeavor would hurt patients, but if we all agreed in concert, then for better or for worse, something would have to give. The existing system is already hurting everyone, and physicians, by agreeing to play this awful game, are complicit in letting insurers dictate the care our patients receive.

Dinah Miller, MD, is a coauthor of Committed: The Battle Over Involuntary Psychiatric Care (Johns Hopkins University Press, 2016) and has a private practice and is an assistant professor of psychiatry and behavioral sciences at Johns Hopkins in Baltimore.

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