MDedge Infectious Disease

TOPLINE:

Although the combination of fecal microbiota transplantation (FMT) with bezlotoxumab was well-tolerated in patients with inflammatory bowel disease (IBD) and recurrent Clostridioides difficile infection (CDI), there›s no clear benefit to using both vs FMT alone.

METHODOLOGY:

• Researchers conducted a randomized placebo-controlled trial among 61 patients with IBD (20 with Crohn’s disease and 41 with ulcerative colitis) who had two or more episodes of CDI.
• All participants received a single colonoscopic FMT from a universal stool bank and were randomly assigned to receive a single bezlotoxumab infusion or placebo infusion before or at the time of the FMT.
• Patients were measured for CDI recurrence, defined as presence of diarrhea and positive glutamate dehydrogenase and enzyme immunoassay toxin test results, up to week 8 after treatment.
• Researchers also looked at C difficile decolonization, defined as absence of diarrhea and negative polymerase chain reaction (PCR) test results, and changes in IBD disease activity through week 12.

TAKEAWAY:

• Five participants (8%) had a CDI recurrence, including four who received bezlotoxumab and one who received placebo (13% vs 3%).
• Although participants in the treatment arm had higher odds of CDI recurrence, the difference wasn’t statistically significant.
• More patients who received bezlotoxumab were decolonized compared to placebo, both at week 1 (82% vs 68%) and week 12 (83% vs 72%), though the difference wasn’t statistically significant.
• There weren’t any significant differences in IBD outcomes, although there were higher rates of IBD improvement among those who received bezlotoxumab (56% vs 46%).

IN PRACTICE:

“As bezlotoxumab can be used to prevent recurrence in high-risk patients during their first episode of CDI, it may be more appropriate to use these therapies early and sequentially,” the study authors wrote.

SOURCE:

The study, with first author Jessica R. Allegretti, MD, MPH, from Brigham and Women’s Hospital, Boston, Massachusetts, was published online on March 19 in the American Journal of Gastroenterology.

LIMITATIONS:

The study was limited by the sample size and inclusion of PCR-only testing for the qualifying episode.

DISCLOSURES:

The trial was funded by an investigator-initiated grant from Merck Sharpe and Dohme. Several authors reported consultancy fees, research grants, and advisory board member roles with numerous pharmaceutical companies.

A version of this article appeared on Medscape.com.

TOPLINE:

Although the combination of fecal microbiota transplantation (FMT) with bezlotoxumab was well-tolerated in patients with inflammatory bowel disease (IBD) and recurrent Clostridioides difficile infection (CDI), there›s no clear benefit to using both vs FMT alone.

METHODOLOGY:

• Researchers conducted a randomized placebo-controlled trial among 61 patients with IBD (20 with Crohn’s disease and 41 with ulcerative colitis) who had two or more episodes of CDI.
• All participants received a single colonoscopic FMT from a universal stool bank and were randomly assigned to receive a single bezlotoxumab infusion or placebo infusion before or at the time of the FMT.
• Patients were measured for CDI recurrence, defined as presence of diarrhea and positive glutamate dehydrogenase and enzyme immunoassay toxin test results, up to week 8 after treatment.
• Researchers also looked at C difficile decolonization, defined as absence of diarrhea and negative polymerase chain reaction (PCR) test results, and changes in IBD disease activity through week 12.

TAKEAWAY:

• Five participants (8%) had a CDI recurrence, including four who received bezlotoxumab and one who received placebo (13% vs 3%).
• Although participants in the treatment arm had higher odds of CDI recurrence, the difference wasn’t statistically significant.
• More patients who received bezlotoxumab were decolonized compared to placebo, both at week 1 (82% vs 68%) and week 12 (83% vs 72%), though the difference wasn’t statistically significant.
• There weren’t any significant differences in IBD outcomes, although there were higher rates of IBD improvement among those who received bezlotoxumab (56% vs 46%).

IN PRACTICE:

“As bezlotoxumab can be used to prevent recurrence in high-risk patients during their first episode of CDI, it may be more appropriate to use these therapies early and sequentially,” the study authors wrote.

SOURCE:

The study, with first author Jessica R. Allegretti, MD, MPH, from Brigham and Women’s Hospital, Boston, Massachusetts, was published online on March 19 in the American Journal of Gastroenterology.

LIMITATIONS:

The study was limited by the sample size and inclusion of PCR-only testing for the qualifying episode.

DISCLOSURES:

The trial was funded by an investigator-initiated grant from Merck Sharpe and Dohme. Several authors reported consultancy fees, research grants, and advisory board member roles with numerous pharmaceutical companies.

A version of this article appeared on Medscape.com.

TOPLINE:

Although the combination of fecal microbiota transplantation (FMT) with bezlotoxumab was well-tolerated in patients with inflammatory bowel disease (IBD) and recurrent Clostridioides difficile infection (CDI), there›s no clear benefit to using both vs FMT alone.

METHODOLOGY:

• Researchers conducted a randomized placebo-controlled trial among 61 patients with IBD (20 with Crohn’s disease and 41 with ulcerative colitis) who had two or more episodes of CDI.
• All participants received a single colonoscopic FMT from a universal stool bank and were randomly assigned to receive a single bezlotoxumab infusion or placebo infusion before or at the time of the FMT.
• Patients were measured for CDI recurrence, defined as presence of diarrhea and positive glutamate dehydrogenase and enzyme immunoassay toxin test results, up to week 8 after treatment.
• Researchers also looked at C difficile decolonization, defined as absence of diarrhea and negative polymerase chain reaction (PCR) test results, and changes in IBD disease activity through week 12.

TAKEAWAY:

• Five participants (8%) had a CDI recurrence, including four who received bezlotoxumab and one who received placebo (13% vs 3%).
• Although participants in the treatment arm had higher odds of CDI recurrence, the difference wasn’t statistically significant.
• More patients who received bezlotoxumab were decolonized compared to placebo, both at week 1 (82% vs 68%) and week 12 (83% vs 72%), though the difference wasn’t statistically significant.
• There weren’t any significant differences in IBD outcomes, although there were higher rates of IBD improvement among those who received bezlotoxumab (56% vs 46%).

IN PRACTICE:

“As bezlotoxumab can be used to prevent recurrence in high-risk patients during their first episode of CDI, it may be more appropriate to use these therapies early and sequentially,” the study authors wrote.

SOURCE:

The study, with first author Jessica R. Allegretti, MD, MPH, from Brigham and Women’s Hospital, Boston, Massachusetts, was published online on March 19 in the American Journal of Gastroenterology.

LIMITATIONS:

The study was limited by the sample size and inclusion of PCR-only testing for the qualifying episode.

DISCLOSURES:

The trial was funded by an investigator-initiated grant from Merck Sharpe and Dohme. Several authors reported consultancy fees, research grants, and advisory board member roles with numerous pharmaceutical companies.

A version of this article appeared on Medscape.com.

Nonprofit hospitals created largely to serve the poor are adding concierge physician practices, charging patients annual membership fees of $2,000 or more for easier access to their doctors.

It’s a trend that began decades ago with physician practices. Thousands of doctors have shifted to the concierge model, in which they can increase their income while decreasing their patient load.

Northwestern Medicine in Chicago, Penn Medicine in Philadelphia, University Hospitals in the Cleveland area, and Baptist Health in Miami are among the large hospital systems offering concierge physician services. The fees, which can exceed $4,000 a year, are in addition to copayments, deductibles, and other charges not paid by patients’ insurance plans.

Critics of concierge medicine say the practice exacerbates primary care shortages, ensuring access only for the affluent, while driving up health care costs. But for tax-exempt hospitals, the financial benefits can be twofold. Concierge fees provide new revenue directly and serve as a tool to help recruit and retain physicians. Those doctors then provide lucrative referrals of their well-heeled patients to the hospitals that employ them.

“Hospitals are attracted to physicians that offer concierge services because their patients do not come with bad debts or a need for charity care, and most of them have private insurance which pays the hospital very well,” said Gerard Anderson, a hospital finance expert at Johns Hopkins University.

“They are the ideal patient, from the hospitals’ perspective.”

Concierge physicians typically limit their practices to a few hundred patients, compared with a couple of thousand for a traditional primary care doctor, so they can promise immediate access and longer visits.

“Every time we see these models expand, we are contracting the availability of primary care doctors for the general population,” said Jewel Mullen, associate dean for health equity at the University of Texas-Austin’s Dell Medical School. The former Connecticut health commissioner said concierge doctors join large hospital systems because of the institutions’ reputations, while hospitals sign up concierge physicians to ensure referrals to specialists and inpatient care. “It helps hospitals secure a bigger piece of their market,” she said.

Concierge physicians typically promise same-day or next-day appointments. Many provide patients their mobile phone number.

Aaron Klein, who oversees the concierge physician practices at Baptist Health, said the program was initially intended to serve donors.

“High-end donors wanted to make sure they have doctors to care for them,” he said.

Baptist opened its concierge program in 2019 and now has three practices across South Florida, where patients pay $2,500 a year.

“My philosophy is: It’s better to give world-class care to a few hundred patients rather than provide inadequate care to a few thousand patients,” Klein said.

Concierge physician practices started more than 20 years ago, mainly in upscale areas such as Boca Raton, Florida, and La Jolla, California. They catered mostly to wealthy retirees willing to pay extra for better physician access. Some of the first physician practices to enter the business were backed by private equity firms.

One of the largest, Boca Raton-based MDVIP, has more than 1,100 physicians and more than 390,000 patients. It was started in 2000, and since 2014 private equity firms have owned a majority stake in the company.

Some concierge physicians say their more attentive care means healthier patients. A study published last year by researchers at the University of California-Berkeley and University of Pennsylvania found no impact on mortality rates. What the study did find: higher costs.

Using Medicare claims data, the researchers found that concierge medicine enrollment corresponded with a 30%-50% increase in total health care spending by patients.

For hospitals, “this is an extension of them consolidating the market,” said Adam Leive, a study co-author and an assistant professor of public policy at UC Berkeley. Inova Health Care Services in Fairfax, Virginia, one of the state’s largest tax-exempt hospital chains, employs 18 concierge doctors, who each handle no more than 400 patients. Those patients pay $2,200 a year for the privilege.

George Salem, 70, of McLean, Virginia, has been a patient in Inova’s concierge practice for several years along with his wife. Earlier this year he slammed his finger in a hotel door, he said. As soon as he got home, he called his physician, who saw him immediately and stitched up the wound. He said he sees his doctor about 10 to 12 times a year.

“I loved my internist before, but it was impossible to get to see him,” Salem said. Immediate access to his doctor “very much gives me peace of mind,” he said.

Craig Cheifetz, a vice president at Inova who oversees the concierge program, said the hospital system took interest in the model after MDVIP began moving aggressively into the Washington, D.C., suburbs about a decade ago. Today, Inova’s program has 6,000 patients.

Cheifetz disputes the charge that concierge physician programs exacerbate primary care shortages. The model keeps doctors who were considering retiring early in the business with a lighter caseload, he said. And the fees amount to no more than a few dollars a day — about what some people spend on coffee, he said.

“Inova has an incredible primary care network for those who can’t afford the concierge care,” he said. “We are still providing all that is necessary in primary care for those who need it.”

Some hospitals are starting concierge physician practices far from their home locations. For example, Tampa General Hospital in Florida last year opened a concierge practice in upper-middle-class Palm Beach Gardens, a roughly three-hour drive from Tampa. Mount Sinai Health System in New York runs a concierge physician practice in West Palm Beach.

NCH Healthcare System in Naples, Florida, employs 12 concierge physicians who treat about 3,000 patients total. “We found a need in this community for those who wanted a more personalized health care experience,” said James Brinkert, regional administrator for the system. Members pay an annual fee of at least $3,500.

NCH patients whose doctors convert to concierge and who don’t want to pay the membership fee are referred to other primary care practices or to urgent care, Brinkert said.

KFF Health News  is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about  KFF .

Nonprofit hospitals created largely to serve the poor are adding concierge physician practices, charging patients annual membership fees of $2,000 or more for easier access to their doctors.

It’s a trend that began decades ago with physician practices. Thousands of doctors have shifted to the concierge model, in which they can increase their income while decreasing their patient load.

Northwestern Medicine in Chicago, Penn Medicine in Philadelphia, University Hospitals in the Cleveland area, and Baptist Health in Miami are among the large hospital systems offering concierge physician services. The fees, which can exceed $4,000 a year, are in addition to copayments, deductibles, and other charges not paid by patients’ insurance plans.

Critics of concierge medicine say the practice exacerbates primary care shortages, ensuring access only for the affluent, while driving up health care costs. But for tax-exempt hospitals, the financial benefits can be twofold. Concierge fees provide new revenue directly and serve as a tool to help recruit and retain physicians. Those doctors then provide lucrative referrals of their well-heeled patients to the hospitals that employ them.

“Hospitals are attracted to physicians that offer concierge services because their patients do not come with bad debts or a need for charity care, and most of them have private insurance which pays the hospital very well,” said Gerard Anderson, a hospital finance expert at Johns Hopkins University.

“They are the ideal patient, from the hospitals’ perspective.”

Concierge physicians typically limit their practices to a few hundred patients, compared with a couple of thousand for a traditional primary care doctor, so they can promise immediate access and longer visits.

“Every time we see these models expand, we are contracting the availability of primary care doctors for the general population,” said Jewel Mullen, associate dean for health equity at the University of Texas-Austin’s Dell Medical School. The former Connecticut health commissioner said concierge doctors join large hospital systems because of the institutions’ reputations, while hospitals sign up concierge physicians to ensure referrals to specialists and inpatient care. “It helps hospitals secure a bigger piece of their market,” she said.

Concierge physicians typically promise same-day or next-day appointments. Many provide patients their mobile phone number.

Aaron Klein, who oversees the concierge physician practices at Baptist Health, said the program was initially intended to serve donors.

“High-end donors wanted to make sure they have doctors to care for them,” he said.

Baptist opened its concierge program in 2019 and now has three practices across South Florida, where patients pay $2,500 a year.

“My philosophy is: It’s better to give world-class care to a few hundred patients rather than provide inadequate care to a few thousand patients,” Klein said.

Concierge physician practices started more than 20 years ago, mainly in upscale areas such as Boca Raton, Florida, and La Jolla, California. They catered mostly to wealthy retirees willing to pay extra for better physician access. Some of the first physician practices to enter the business were backed by private equity firms.

One of the largest, Boca Raton-based MDVIP, has more than 1,100 physicians and more than 390,000 patients. It was started in 2000, and since 2014 private equity firms have owned a majority stake in the company.

Some concierge physicians say their more attentive care means healthier patients. A study published last year by researchers at the University of California-Berkeley and University of Pennsylvania found no impact on mortality rates. What the study did find: higher costs.

Using Medicare claims data, the researchers found that concierge medicine enrollment corresponded with a 30%-50% increase in total health care spending by patients.

For hospitals, “this is an extension of them consolidating the market,” said Adam Leive, a study co-author and an assistant professor of public policy at UC Berkeley. Inova Health Care Services in Fairfax, Virginia, one of the state’s largest tax-exempt hospital chains, employs 18 concierge doctors, who each handle no more than 400 patients. Those patients pay $2,200 a year for the privilege.

George Salem, 70, of McLean, Virginia, has been a patient in Inova’s concierge practice for several years along with his wife. Earlier this year he slammed his finger in a hotel door, he said. As soon as he got home, he called his physician, who saw him immediately and stitched up the wound. He said he sees his doctor about 10 to 12 times a year.

“I loved my internist before, but it was impossible to get to see him,” Salem said. Immediate access to his doctor “very much gives me peace of mind,” he said.

Craig Cheifetz, a vice president at Inova who oversees the concierge program, said the hospital system took interest in the model after MDVIP began moving aggressively into the Washington, D.C., suburbs about a decade ago. Today, Inova’s program has 6,000 patients.

Cheifetz disputes the charge that concierge physician programs exacerbate primary care shortages. The model keeps doctors who were considering retiring early in the business with a lighter caseload, he said. And the fees amount to no more than a few dollars a day — about what some people spend on coffee, he said.

“Inova has an incredible primary care network for those who can’t afford the concierge care,” he said. “We are still providing all that is necessary in primary care for those who need it.”

Some hospitals are starting concierge physician practices far from their home locations. For example, Tampa General Hospital in Florida last year opened a concierge practice in upper-middle-class Palm Beach Gardens, a roughly three-hour drive from Tampa. Mount Sinai Health System in New York runs a concierge physician practice in West Palm Beach.

NCH Healthcare System in Naples, Florida, employs 12 concierge physicians who treat about 3,000 patients total. “We found a need in this community for those who wanted a more personalized health care experience,” said James Brinkert, regional administrator for the system. Members pay an annual fee of at least $3,500.

NCH patients whose doctors convert to concierge and who don’t want to pay the membership fee are referred to other primary care practices or to urgent care, Brinkert said.

KFF Health News  is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about  KFF .

Nonprofit hospitals created largely to serve the poor are adding concierge physician practices, charging patients annual membership fees of $2,000 or more for easier access to their doctors.

It’s a trend that began decades ago with physician practices. Thousands of doctors have shifted to the concierge model, in which they can increase their income while decreasing their patient load.

Northwestern Medicine in Chicago, Penn Medicine in Philadelphia, University Hospitals in the Cleveland area, and Baptist Health in Miami are among the large hospital systems offering concierge physician services. The fees, which can exceed $4,000 a year, are in addition to copayments, deductibles, and other charges not paid by patients’ insurance plans.

Critics of concierge medicine say the practice exacerbates primary care shortages, ensuring access only for the affluent, while driving up health care costs. But for tax-exempt hospitals, the financial benefits can be twofold. Concierge fees provide new revenue directly and serve as a tool to help recruit and retain physicians. Those doctors then provide lucrative referrals of their well-heeled patients to the hospitals that employ them.

“Hospitals are attracted to physicians that offer concierge services because their patients do not come with bad debts or a need for charity care, and most of them have private insurance which pays the hospital very well,” said Gerard Anderson, a hospital finance expert at Johns Hopkins University.

“They are the ideal patient, from the hospitals’ perspective.”

Concierge physicians typically limit their practices to a few hundred patients, compared with a couple of thousand for a traditional primary care doctor, so they can promise immediate access and longer visits.

“Every time we see these models expand, we are contracting the availability of primary care doctors for the general population,” said Jewel Mullen, associate dean for health equity at the University of Texas-Austin’s Dell Medical School. The former Connecticut health commissioner said concierge doctors join large hospital systems because of the institutions’ reputations, while hospitals sign up concierge physicians to ensure referrals to specialists and inpatient care. “It helps hospitals secure a bigger piece of their market,” she said.

Concierge physicians typically promise same-day or next-day appointments. Many provide patients their mobile phone number.

Aaron Klein, who oversees the concierge physician practices at Baptist Health, said the program was initially intended to serve donors.

“High-end donors wanted to make sure they have doctors to care for them,” he said.

Baptist opened its concierge program in 2019 and now has three practices across South Florida, where patients pay $2,500 a year.

“My philosophy is: It’s better to give world-class care to a few hundred patients rather than provide inadequate care to a few thousand patients,” Klein said.

Concierge physician practices started more than 20 years ago, mainly in upscale areas such as Boca Raton, Florida, and La Jolla, California. They catered mostly to wealthy retirees willing to pay extra for better physician access. Some of the first physician practices to enter the business were backed by private equity firms.

One of the largest, Boca Raton-based MDVIP, has more than 1,100 physicians and more than 390,000 patients. It was started in 2000, and since 2014 private equity firms have owned a majority stake in the company.

Some concierge physicians say their more attentive care means healthier patients. A study published last year by researchers at the University of California-Berkeley and University of Pennsylvania found no impact on mortality rates. What the study did find: higher costs.

Using Medicare claims data, the researchers found that concierge medicine enrollment corresponded with a 30%-50% increase in total health care spending by patients.

For hospitals, “this is an extension of them consolidating the market,” said Adam Leive, a study co-author and an assistant professor of public policy at UC Berkeley. Inova Health Care Services in Fairfax, Virginia, one of the state’s largest tax-exempt hospital chains, employs 18 concierge doctors, who each handle no more than 400 patients. Those patients pay $2,200 a year for the privilege.

George Salem, 70, of McLean, Virginia, has been a patient in Inova’s concierge practice for several years along with his wife. Earlier this year he slammed his finger in a hotel door, he said. As soon as he got home, he called his physician, who saw him immediately and stitched up the wound. He said he sees his doctor about 10 to 12 times a year.

“I loved my internist before, but it was impossible to get to see him,” Salem said. Immediate access to his doctor “very much gives me peace of mind,” he said.

Craig Cheifetz, a vice president at Inova who oversees the concierge program, said the hospital system took interest in the model after MDVIP began moving aggressively into the Washington, D.C., suburbs about a decade ago. Today, Inova’s program has 6,000 patients.

Cheifetz disputes the charge that concierge physician programs exacerbate primary care shortages. The model keeps doctors who were considering retiring early in the business with a lighter caseload, he said. And the fees amount to no more than a few dollars a day — about what some people spend on coffee, he said.

“Inova has an incredible primary care network for those who can’t afford the concierge care,” he said. “We are still providing all that is necessary in primary care for those who need it.”

Some hospitals are starting concierge physician practices far from their home locations. For example, Tampa General Hospital in Florida last year opened a concierge practice in upper-middle-class Palm Beach Gardens, a roughly three-hour drive from Tampa. Mount Sinai Health System in New York runs a concierge physician practice in West Palm Beach.

NCH Healthcare System in Naples, Florida, employs 12 concierge physicians who treat about 3,000 patients total. “We found a need in this community for those who wanted a more personalized health care experience,” said James Brinkert, regional administrator for the system. Members pay an annual fee of at least $3,500.

NCH patients whose doctors convert to concierge and who don’t want to pay the membership fee are referred to other primary care practices or to urgent care, Brinkert said.

KFF Health News  is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about  KFF .

The Epstein-Barr virus (EBV) is our constant companion, infecting an estimated 90%-95% of adults. Many of us are first infected as children, when the germ may trigger cold and flu symptoms. EBV also causes mononucleosis, or kissing disease, a glandular fever that has afflicted generations of amorous young people.

Post infection, EBV settles in for the long haul and remains in the body until death. It’s thought to be largely innocuous, but EBV is now implicated as a cause of several types of cancer — including lymphoma and nasopharyngeal tumors – and multiple sclerosis (MS). In 2022, a landmark study in Science suggested that previous EBV infection is the primary cause of MS.

While there aren’t many implications for current treatment, greater insight into the origin story of MS may eventually help neurologists better diagnose and treat patients, experts said. The goal is to uncover clues that “can help us understand MS a little bit better and reveal insights that could lead to new disease-modifying therapy,” Bruce Bebo, PhD, executive vice president of research with the National MS Society, said in an interview.
 

EBV Boosts MS Risk 32-Fold

EBV was first linked to MS back in 1981. For the 2022 study, researchers at the Harvard T.H. Chan School of Public Health and Harvard Medical School, Boston, analyzed blood serum from 10 million active-duty members of the US military. They focused on 801 recruits with MS and matched them with more than 1500 controls. All but one of those with MS had been infected with EBV; infection appeared to boost the risk for MS 32-fold (95% CI, 4.3-245.3; P < .001).

Neurologist and associate professor Michael Levy, MD, PhD, of Harvard Medical School and Massachusetts General Hospital, said in an interview that the findings are “groundbreaking” and confirm that EBV is “likely the primary cause of MS.”

According to Dr. Levy, there are two main theories about why EBV causes MS. The first hypothesis, known as the “molecular mimicry” theory, suggests that “EBV is a trigger of MS, possibly when the immune system mistakes a viral protein for a myelin protein and then attacks myelin,” Dr. Levy said. In MS, the immune system attacks the protective myelin sheath and the axons it insulates.

“After that point, the virus is not necessary to maintain the disease state and eradicating the virus likely won’t have much effect since the immune response is already triggered,” he said.

The second theory is that “EBV is a driver of MS where there is an ongoing, lifelong immunological response to EBV that continuously causes damage in the central nervous system [CNS]. In theory, if we could eradicate the virus, the destructive immune response could also resolve. Thus, an EBV antiviral treatment could potentially treat and maybe cure MS,” Dr. Levy explained, noting that “removing the pathogenic antigen may be a more effective strategy than removing the immune response.”

However, “we don’t yet know which hypothesis is correct,” he said. But “there is preliminary evidence in favor of each one.”
 

‘Additional Fuses Must Be Ignited’

It’s also unclear why most people infected with EBV do not develop MS. It appears that “additional fuses must be ignited,” for MS to take hold, according to a commentary accompanying the landmark 2022 study.

“As far as clinical implications, knowing whether a patient has a medical or family history of mononucleosis may be a small clue, a small piece of evidence, to help with diagnosis,” Dr. Bebo said.

He agreed with Dr. Levy that an antiviral could be a promising approach “If the problem in MS is a dysfunctional immune response to EBV.”

Natalia Drosu, MD, PhD, a postdoctoral fellow at Harvard-MIT Biomedical Engineering Center, said that a clinical trial of a non-immunosuppressive antiviral targeting EBV in patients with MS would be a crucial step toward better understanding the MS-EBV connection. “If we learn that antivirals are effective in MS, we should develop non-immunosuppressive therapies for patients with MS as soon as possible,” she said.

Stanford University’s Lawrence Steinman, MD, professor of neurology and neurological sciences, pediatrics, and genetics, who coauthored the commentary on the original Science paper, agreed that it’s worth investigating whether antiviral therapies targeting EBV will benefit patients who already have MS. But he cautioned against clinicians experimenting on their own outside of a research study. “You’d want to use the right antiviral and a properly designed trial,” he said.
 

Antivirals May Place a Crucial Role in MS Control

While there are no approved therapies for EBV, several MS disease-modifying therapies have anti-EBV effects, Dr. Levy said, citing anti-CD20 therapy as a clear example. It depletes B cells from the circulation, and it depletes EBV because the virus lives in the B-cell compartment. “Some MS treatments may be inadvertent EBV antivirals,” he said.

Researchers are also thinking about how they might exploit the MS-EBV link to prevent MS from developing in the first place, but there are uncertainties on that front too.

Conceivably, there may be some way to intervene in patients to treat EBV and prevent MS, such as a unique treatment for infectious mononucleosis (IM), Dr. Levy said.

Researchers are especially intrigued by signs that the timing of infection may play a role, with people infected with EBV via IM after early childhood at especially a high risk of developing MS. A 2022 German study calculated that people who developed IM were almost twice as likely as those who didn’t to develop MS within 10 years, although the risks in both groups were very small. Subgroup analysis revealed the strongest association between IM and MS was in the group infected between age 14 and 20 years (hazard ratio, 3.52; 95% CI, 1.00-12.37). They also saw a stronger association in men than in women.

The authors of a 2023 review in Clinical & Translational Immunology wrote that “further understanding of IM may be critical in solving the mystery” of EBV’s role in MS.

Dr. Levy said this line of questioning is important. “In theory, if we can tell who is prone to develop MS or whose immune system might be reacting to EBV to cause MS, we can intervene early to prevent neurological manifestations.”

However, “remember that while most of the world gets EBV infections, only 1 in 1000 will get MS. So, it might not be feasible to test everyone before neurological manifestations occur,” he said.
 

More Questions to Answer About EBV and MS

Researchers hope to answer several questions moving forward. For one, why is EBV uniquely connected to MS? “You would think that if there were cross-reactivity to myelin, there are many viruses that could cause MS. But the association seems to be very restricted to EBV,” Dr. Levy said. “It is probably due to the fact that EBV is one of the only human viruses that can infect B cells, which play important roles in controlling immune responses.”

The molecular mimicry theory also opens up a potential treatment pathway.

A 2022 study reported “high-affinity molecular mimicry between the EBV transcription factor EBV nuclear antigen 1 (EBNA1) and the central nervous system protein glial cell adhesion molecule (GlialCAM)”. Antibodies against EBNA1 and GlialCAM are prevalent in patients with MS. In a mouse model of MS, the researchers showed that EBNA1 immunization exacerbates disease. The authors wrote that “Our results provide a mechanistic link for the association between MS and EBV and could guide the development of new MS therapies.”
 

Could an EBV Vaccine Be the Answer?

On the prevention front, perhaps the most obvious question is whether an EBV vaccine could eliminate MS for good?

Dr. Bebo, from the National MS Society, said it will be important to determine which kind of vaccine is best. Is it one that neutralizes infection with EBV? Or is it enough to simply prevent clinical manifestations?

Both types of vaccines are in development, and at least two clinical trials are now in the works. The National Institute of Allergy and Infectious Diseases is sponsoring a phase 1 study of an adjuvanted EBV gp350-Ferritin nanoparticle vaccine. Forty subjects aged 18-29 years will take part: 20 with EBV and 20 who are not infected. The study is expected to end in 2025.

There is also a phase 1 placebo-controlled study in progress testing an EBV vaccine based on mRNA-1189 in 422 subjects aged 12-30 years. This trial is also due to end in 2025.

“This is very exciting, but it may take a decade or two to determine whether a vaccine is effective at preventing MS,” Dr. Levy said.

Dr. Levy, Dr. Steinman, Dr. Drosu, and Dr. Bebo had no disclosures.
 

A version of this article appeared on Medscape.com.

The Epstein-Barr virus (EBV) is our constant companion, infecting an estimated 90%-95% of adults. Many of us are first infected as children, when the germ may trigger cold and flu symptoms. EBV also causes mononucleosis, or kissing disease, a glandular fever that has afflicted generations of amorous young people.

Post infection, EBV settles in for the long haul and remains in the body until death. It’s thought to be largely innocuous, but EBV is now implicated as a cause of several types of cancer — including lymphoma and nasopharyngeal tumors – and multiple sclerosis (MS). In 2022, a landmark study in Science suggested that previous EBV infection is the primary cause of MS.

While there aren’t many implications for current treatment, greater insight into the origin story of MS may eventually help neurologists better diagnose and treat patients, experts said. The goal is to uncover clues that “can help us understand MS a little bit better and reveal insights that could lead to new disease-modifying therapy,” Bruce Bebo, PhD, executive vice president of research with the National MS Society, said in an interview.
 

EBV Boosts MS Risk 32-Fold

EBV was first linked to MS back in 1981. For the 2022 study, researchers at the Harvard T.H. Chan School of Public Health and Harvard Medical School, Boston, analyzed blood serum from 10 million active-duty members of the US military. They focused on 801 recruits with MS and matched them with more than 1500 controls. All but one of those with MS had been infected with EBV; infection appeared to boost the risk for MS 32-fold (95% CI, 4.3-245.3; P < .001).

Neurologist and associate professor Michael Levy, MD, PhD, of Harvard Medical School and Massachusetts General Hospital, said in an interview that the findings are “groundbreaking” and confirm that EBV is “likely the primary cause of MS.”

According to Dr. Levy, there are two main theories about why EBV causes MS. The first hypothesis, known as the “molecular mimicry” theory, suggests that “EBV is a trigger of MS, possibly when the immune system mistakes a viral protein for a myelin protein and then attacks myelin,” Dr. Levy said. In MS, the immune system attacks the protective myelin sheath and the axons it insulates.

“After that point, the virus is not necessary to maintain the disease state and eradicating the virus likely won’t have much effect since the immune response is already triggered,” he said.

The second theory is that “EBV is a driver of MS where there is an ongoing, lifelong immunological response to EBV that continuously causes damage in the central nervous system [CNS]. In theory, if we could eradicate the virus, the destructive immune response could also resolve. Thus, an EBV antiviral treatment could potentially treat and maybe cure MS,” Dr. Levy explained, noting that “removing the pathogenic antigen may be a more effective strategy than removing the immune response.”

However, “we don’t yet know which hypothesis is correct,” he said. But “there is preliminary evidence in favor of each one.”
 

‘Additional Fuses Must Be Ignited’

It’s also unclear why most people infected with EBV do not develop MS. It appears that “additional fuses must be ignited,” for MS to take hold, according to a commentary accompanying the landmark 2022 study.

“As far as clinical implications, knowing whether a patient has a medical or family history of mononucleosis may be a small clue, a small piece of evidence, to help with diagnosis,” Dr. Bebo said.

He agreed with Dr. Levy that an antiviral could be a promising approach “If the problem in MS is a dysfunctional immune response to EBV.”

Natalia Drosu, MD, PhD, a postdoctoral fellow at Harvard-MIT Biomedical Engineering Center, said that a clinical trial of a non-immunosuppressive antiviral targeting EBV in patients with MS would be a crucial step toward better understanding the MS-EBV connection. “If we learn that antivirals are effective in MS, we should develop non-immunosuppressive therapies for patients with MS as soon as possible,” she said.

Stanford University’s Lawrence Steinman, MD, professor of neurology and neurological sciences, pediatrics, and genetics, who coauthored the commentary on the original Science paper, agreed that it’s worth investigating whether antiviral therapies targeting EBV will benefit patients who already have MS. But he cautioned against clinicians experimenting on their own outside of a research study. “You’d want to use the right antiviral and a properly designed trial,” he said.
 

Antivirals May Place a Crucial Role in MS Control

While there are no approved therapies for EBV, several MS disease-modifying therapies have anti-EBV effects, Dr. Levy said, citing anti-CD20 therapy as a clear example. It depletes B cells from the circulation, and it depletes EBV because the virus lives in the B-cell compartment. “Some MS treatments may be inadvertent EBV antivirals,” he said.

Researchers are also thinking about how they might exploit the MS-EBV link to prevent MS from developing in the first place, but there are uncertainties on that front too.

Conceivably, there may be some way to intervene in patients to treat EBV and prevent MS, such as a unique treatment for infectious mononucleosis (IM), Dr. Levy said.

Researchers are especially intrigued by signs that the timing of infection may play a role, with people infected with EBV via IM after early childhood at especially a high risk of developing MS. A 2022 German study calculated that people who developed IM were almost twice as likely as those who didn’t to develop MS within 10 years, although the risks in both groups were very small. Subgroup analysis revealed the strongest association between IM and MS was in the group infected between age 14 and 20 years (hazard ratio, 3.52; 95% CI, 1.00-12.37). They also saw a stronger association in men than in women.

The authors of a 2023 review in Clinical & Translational Immunology wrote that “further understanding of IM may be critical in solving the mystery” of EBV’s role in MS.

Dr. Levy said this line of questioning is important. “In theory, if we can tell who is prone to develop MS or whose immune system might be reacting to EBV to cause MS, we can intervene early to prevent neurological manifestations.”

However, “remember that while most of the world gets EBV infections, only 1 in 1000 will get MS. So, it might not be feasible to test everyone before neurological manifestations occur,” he said.
 

More Questions to Answer About EBV and MS

Researchers hope to answer several questions moving forward. For one, why is EBV uniquely connected to MS? “You would think that if there were cross-reactivity to myelin, there are many viruses that could cause MS. But the association seems to be very restricted to EBV,” Dr. Levy said. “It is probably due to the fact that EBV is one of the only human viruses that can infect B cells, which play important roles in controlling immune responses.”

The molecular mimicry theory also opens up a potential treatment pathway.

A 2022 study reported “high-affinity molecular mimicry between the EBV transcription factor EBV nuclear antigen 1 (EBNA1) and the central nervous system protein glial cell adhesion molecule (GlialCAM)”. Antibodies against EBNA1 and GlialCAM are prevalent in patients with MS. In a mouse model of MS, the researchers showed that EBNA1 immunization exacerbates disease. The authors wrote that “Our results provide a mechanistic link for the association between MS and EBV and could guide the development of new MS therapies.”
 

Could an EBV Vaccine Be the Answer?

On the prevention front, perhaps the most obvious question is whether an EBV vaccine could eliminate MS for good?

Dr. Bebo, from the National MS Society, said it will be important to determine which kind of vaccine is best. Is it one that neutralizes infection with EBV? Or is it enough to simply prevent clinical manifestations?

Both types of vaccines are in development, and at least two clinical trials are now in the works. The National Institute of Allergy and Infectious Diseases is sponsoring a phase 1 study of an adjuvanted EBV gp350-Ferritin nanoparticle vaccine. Forty subjects aged 18-29 years will take part: 20 with EBV and 20 who are not infected. The study is expected to end in 2025.

There is also a phase 1 placebo-controlled study in progress testing an EBV vaccine based on mRNA-1189 in 422 subjects aged 12-30 years. This trial is also due to end in 2025.

“This is very exciting, but it may take a decade or two to determine whether a vaccine is effective at preventing MS,” Dr. Levy said.

Dr. Levy, Dr. Steinman, Dr. Drosu, and Dr. Bebo had no disclosures.
 

A version of this article appeared on Medscape.com.

The Epstein-Barr virus (EBV) is our constant companion, infecting an estimated 90%-95% of adults. Many of us are first infected as children, when the germ may trigger cold and flu symptoms. EBV also causes mononucleosis, or kissing disease, a glandular fever that has afflicted generations of amorous young people.

Post infection, EBV settles in for the long haul and remains in the body until death. It’s thought to be largely innocuous, but EBV is now implicated as a cause of several types of cancer — including lymphoma and nasopharyngeal tumors – and multiple sclerosis (MS). In 2022, a landmark study in Science suggested that previous EBV infection is the primary cause of MS.

While there aren’t many implications for current treatment, greater insight into the origin story of MS may eventually help neurologists better diagnose and treat patients, experts said. The goal is to uncover clues that “can help us understand MS a little bit better and reveal insights that could lead to new disease-modifying therapy,” Bruce Bebo, PhD, executive vice president of research with the National MS Society, said in an interview.
 

EBV Boosts MS Risk 32-Fold

EBV was first linked to MS back in 1981. For the 2022 study, researchers at the Harvard T.H. Chan School of Public Health and Harvard Medical School, Boston, analyzed blood serum from 10 million active-duty members of the US military. They focused on 801 recruits with MS and matched them with more than 1500 controls. All but one of those with MS had been infected with EBV; infection appeared to boost the risk for MS 32-fold (95% CI, 4.3-245.3; P < .001).

Neurologist and associate professor Michael Levy, MD, PhD, of Harvard Medical School and Massachusetts General Hospital, said in an interview that the findings are “groundbreaking” and confirm that EBV is “likely the primary cause of MS.”

According to Dr. Levy, there are two main theories about why EBV causes MS. The first hypothesis, known as the “molecular mimicry” theory, suggests that “EBV is a trigger of MS, possibly when the immune system mistakes a viral protein for a myelin protein and then attacks myelin,” Dr. Levy said. In MS, the immune system attacks the protective myelin sheath and the axons it insulates.

“After that point, the virus is not necessary to maintain the disease state and eradicating the virus likely won’t have much effect since the immune response is already triggered,” he said.

The second theory is that “EBV is a driver of MS where there is an ongoing, lifelong immunological response to EBV that continuously causes damage in the central nervous system [CNS]. In theory, if we could eradicate the virus, the destructive immune response could also resolve. Thus, an EBV antiviral treatment could potentially treat and maybe cure MS,” Dr. Levy explained, noting that “removing the pathogenic antigen may be a more effective strategy than removing the immune response.”

However, “we don’t yet know which hypothesis is correct,” he said. But “there is preliminary evidence in favor of each one.”
 

‘Additional Fuses Must Be Ignited’

It’s also unclear why most people infected with EBV do not develop MS. It appears that “additional fuses must be ignited,” for MS to take hold, according to a commentary accompanying the landmark 2022 study.

“As far as clinical implications, knowing whether a patient has a medical or family history of mononucleosis may be a small clue, a small piece of evidence, to help with diagnosis,” Dr. Bebo said.

He agreed with Dr. Levy that an antiviral could be a promising approach “If the problem in MS is a dysfunctional immune response to EBV.”

Natalia Drosu, MD, PhD, a postdoctoral fellow at Harvard-MIT Biomedical Engineering Center, said that a clinical trial of a non-immunosuppressive antiviral targeting EBV in patients with MS would be a crucial step toward better understanding the MS-EBV connection. “If we learn that antivirals are effective in MS, we should develop non-immunosuppressive therapies for patients with MS as soon as possible,” she said.

Stanford University’s Lawrence Steinman, MD, professor of neurology and neurological sciences, pediatrics, and genetics, who coauthored the commentary on the original Science paper, agreed that it’s worth investigating whether antiviral therapies targeting EBV will benefit patients who already have MS. But he cautioned against clinicians experimenting on their own outside of a research study. “You’d want to use the right antiviral and a properly designed trial,” he said.
 

Antivirals May Place a Crucial Role in MS Control

While there are no approved therapies for EBV, several MS disease-modifying therapies have anti-EBV effects, Dr. Levy said, citing anti-CD20 therapy as a clear example. It depletes B cells from the circulation, and it depletes EBV because the virus lives in the B-cell compartment. “Some MS treatments may be inadvertent EBV antivirals,” he said.

Researchers are also thinking about how they might exploit the MS-EBV link to prevent MS from developing in the first place, but there are uncertainties on that front too.

Conceivably, there may be some way to intervene in patients to treat EBV and prevent MS, such as a unique treatment for infectious mononucleosis (IM), Dr. Levy said.

Researchers are especially intrigued by signs that the timing of infection may play a role, with people infected with EBV via IM after early childhood at especially a high risk of developing MS. A 2022 German study calculated that people who developed IM were almost twice as likely as those who didn’t to develop MS within 10 years, although the risks in both groups were very small. Subgroup analysis revealed the strongest association between IM and MS was in the group infected between age 14 and 20 years (hazard ratio, 3.52; 95% CI, 1.00-12.37). They also saw a stronger association in men than in women.

The authors of a 2023 review in Clinical & Translational Immunology wrote that “further understanding of IM may be critical in solving the mystery” of EBV’s role in MS.

Dr. Levy said this line of questioning is important. “In theory, if we can tell who is prone to develop MS or whose immune system might be reacting to EBV to cause MS, we can intervene early to prevent neurological manifestations.”

However, “remember that while most of the world gets EBV infections, only 1 in 1000 will get MS. So, it might not be feasible to test everyone before neurological manifestations occur,” he said.
 

More Questions to Answer About EBV and MS

Researchers hope to answer several questions moving forward. For one, why is EBV uniquely connected to MS? “You would think that if there were cross-reactivity to myelin, there are many viruses that could cause MS. But the association seems to be very restricted to EBV,” Dr. Levy said. “It is probably due to the fact that EBV is one of the only human viruses that can infect B cells, which play important roles in controlling immune responses.”

The molecular mimicry theory also opens up a potential treatment pathway.

A 2022 study reported “high-affinity molecular mimicry between the EBV transcription factor EBV nuclear antigen 1 (EBNA1) and the central nervous system protein glial cell adhesion molecule (GlialCAM)”. Antibodies against EBNA1 and GlialCAM are prevalent in patients with MS. In a mouse model of MS, the researchers showed that EBNA1 immunization exacerbates disease. The authors wrote that “Our results provide a mechanistic link for the association between MS and EBV and could guide the development of new MS therapies.”
 

Could an EBV Vaccine Be the Answer?

On the prevention front, perhaps the most obvious question is whether an EBV vaccine could eliminate MS for good?

Dr. Bebo, from the National MS Society, said it will be important to determine which kind of vaccine is best. Is it one that neutralizes infection with EBV? Or is it enough to simply prevent clinical manifestations?

Both types of vaccines are in development, and at least two clinical trials are now in the works. The National Institute of Allergy and Infectious Diseases is sponsoring a phase 1 study of an adjuvanted EBV gp350-Ferritin nanoparticle vaccine. Forty subjects aged 18-29 years will take part: 20 with EBV and 20 who are not infected. The study is expected to end in 2025.

There is also a phase 1 placebo-controlled study in progress testing an EBV vaccine based on mRNA-1189 in 422 subjects aged 12-30 years. This trial is also due to end in 2025.

“This is very exciting, but it may take a decade or two to determine whether a vaccine is effective at preventing MS,” Dr. Levy said.

Dr. Levy, Dr. Steinman, Dr. Drosu, and Dr. Bebo had no disclosures.
 

A version of this article appeared on Medscape.com.

A review of the federal Open Payments database found that the pharmaceutical and medical device industry paid physicians $12.1 billion over nearly a decade.

Almost two thirds of eligible physicians — 826,313 doctors — received a payment from a drug or device maker from 2013 to 2022, according to a study published online in JAMA on March 28. Overall, the median payment was $48 per physician.

Orthopedists received the largest amount of payments in aggregate, $1.3 billion, followed by neurologists and psychiatrists at $1.2 billion and cardiologists at $1.29 billion.

Geriatric and nuclear medicine specialists and trauma and pediatric surgeons received the least amount of money in aggregate, and the mean amount paid to a pediatric surgeon in the top 0.1% was just $338,183 over the 9-year study period.

Excluding 2013 (the database was established in August that year), the total value of payments was highest in 2019 at $1.6 billion, up from $1.34 billion in 2014. It was lowest in 2020, the peak year of the COVID-19 pandemic, but dipped to $864 billion that year and rebounded to $1.28 billion in 2022, wrote the authors.

The Open Payments database, administered by the Centers for Medicare & Medicaid Services, requires drug and device makers and group purchasing organizations to report payments made to physicians, including for consulting services, speaking fees, food and beverages, travel and lodging, education, gifts, grants, and honoraria.

The database was created to shed light on these payments, which have been linked in multiple studies to more prescribing of a particular drug or more use of a particular device.

The JAMA review appeared to show that with the exception of the pandemic year, the relationships have more or less stayed the same since Open Payments began.

“There’s been no sea change, no massive shift in how these interactions are happening,” said Deborah C. Marshall, MD, assistant professor in the Department of Radiation Oncology at the Icahn School of Medicine at Mount Sinai in New York City, who has studied industry payments.

“There’s no suggestion that anything is really changing other than that’s there is transparency,” said Robert Steinbrook, MD, director of the Health Research Group at Public Citizen.

Still, Dr. Steinbrook told this news organization, “it’s better to know this than to not know this.”

The unchanging nature of industry-physician relationships “suggests that to reduce the volume and magnitude of payments, more would need to be done,” he said.

“Really, this should be banned. Doctors should not be allowed to get gifts from pharmaceutical companies,” said Adriane Fugh-Berman, MD, professor of pharmacology and physiology at Georgetown University, and director of PharmedOut, a Georgetown-based project that advances evidence-based prescribing and educates healthcare professionals about pharmaceutical marketing practices.

“The interactions wouldn’t be happening unless there was a purpose for them,” said Dr. Marshall. The relationships are “built with intention,” Dr. Marshall told this news organization.
 

Top Earners Range From $195,000 to $4.8 Million

Payments to the median physician over the study period ranged from $0 to $2339, but the mean payment to top earners — those in the top 0.1% — ranged from $194,933 for hospitalists to $4.8 million for orthopedic specialists.

Overall, the median payment was $48 per physician.

But small dollar amounts should not be discounted — even if it’s just a $25-catered lunch — said Aaron Mitchell, MD, a medical oncologist and assistant attending physician at Memorial Sloan Kettering Cancer Center in New York City who has studied industry-physician relationships. “The influence is not just in the dollar value,” Dr. Mitchell told this news organization. “It’s about the time listening to and the time in personal contact with industry representatives that these dollars are a marker for,” he said.

“There’s no such thing as a free lunch,” agreed Dr. Marshall. It’s “pretty well established” that lower-value payments do have influence, which is why academic institutions have established policies that limit gifts and meals and other payments from industry, she said.

Dr. Fugh-Berman said, “the size of the gift doesn’t really matter,” adding that research she conducted had shown that “accepting a meal increased not only the expense of the prescriptions that Medicare physicians wrote but also the number of prescriptions.”
 

Payments Mostly for High-Dollar Products

The top 25 drugs and devices that were related to industry payments tended to be high-cost brand-name products.

The top drug was Janssen’s Xarelto, an anticoagulant first approved in 2011 that costs about $600 a month, according to GoodRx. The drug has had annual sales of $4-$6 billion.

Xarelto was followed by Eliquis, another anticoagulant; Humira, used for a variety of autoimmune conditions including plaque psoriasis, rheumatoid arthritis, Crohn’s disease, and ulcerative colitis; Invokana, Jardiance, and Farxiga, all for type 2 diabetes.

The top medical devices included the da Vinci Surgical System, Mako SmartRobotics, CoreValve Evolut, Natrelle Implants, and Impella, a heart pump that received a US Food and Drug Administration (FDA) warning that it was associated with a heightened risk for death.
 

Industry Influence May Lead to Higher Cost, Poor Quality Care

Multiple studies have shown that payments to physicians tend to lead to increased prescribing and, often, higher costs for Medicare, a health system, or patients.

“I’m sure there are still a lot of physicians out there who think they’re getting away with something, that they can take meals, or they can take consulting fees and not be influenced, but there’s overwhelming data showing that it always influences you,” said Dr. Fugh-Berman.

One study in 2020 that used the Open Payments database found that physicians increase prescribing of the drugs for which they receive payment in the months just after the payment. The authors also showed that physicians who are paid prescribe lower-quality drugs following the payment, “although the magnitude is small and unlikely to be clinically significant.”

Dr. Marshall said that more studies are needed to determine whether quality of care is being affected when a physician prescribes a drug after an industry payment.

For now, there seems to be little appetite among physicians to give up the payments, said Dr. Marshall and others.

Physicians in some specialties see the payments as “an implicit statement about their value,” said Dr. Marshall.

In oncology, having received a lot of payments “gets worn more as a badge of honor,” said Dr. Mitchell.

The clinicians believe that “by collaborating with industry we are providing scientific expertise to help develop the next generation of technology and cures,” Dr. Mitchell said, adding that they see the payments “as a mark of their impact.”

Among the JAMA study authors, Joseph S. Ross, MD, reported that he is a deputy editor of JAMA but was not involved in decisions regarding acceptance of the manuscript or its review. Dr. Ross also reported receiving grants from the FDA, Johnson and Johnson, the Medical Devices Innovation Consortium, the Agency for Healthcare Research and Quality, and the National Heart, Lung, and Blood Institute. He was an expert witness in a qui tam suit alleging violations of the False Claims Act and Anti-Kickback Statute against Biogen that was settled in 2022. Dr. Steinbrook, Dr. Marshall, and Dr. Mitchell reported no relevant financial relationships. Dr. Fugh-Berman reported being an expert witness for plaintiffs in complaints about drug and device marketing practices.

A version of this article appeared on Medscape.com.

A review of the federal Open Payments database found that the pharmaceutical and medical device industry paid physicians $12.1 billion over nearly a decade.

Almost two thirds of eligible physicians — 826,313 doctors — received a payment from a drug or device maker from 2013 to 2022, according to a study published online in JAMA on March 28. Overall, the median payment was $48 per physician.

Orthopedists received the largest amount of payments in aggregate, $1.3 billion, followed by neurologists and psychiatrists at $1.2 billion and cardiologists at $1.29 billion.

Geriatric and nuclear medicine specialists and trauma and pediatric surgeons received the least amount of money in aggregate, and the mean amount paid to a pediatric surgeon in the top 0.1% was just $338,183 over the 9-year study period.

Excluding 2013 (the database was established in August that year), the total value of payments was highest in 2019 at $1.6 billion, up from $1.34 billion in 2014. It was lowest in 2020, the peak year of the COVID-19 pandemic, but dipped to $864 billion that year and rebounded to $1.28 billion in 2022, wrote the authors.

The Open Payments database, administered by the Centers for Medicare & Medicaid Services, requires drug and device makers and group purchasing organizations to report payments made to physicians, including for consulting services, speaking fees, food and beverages, travel and lodging, education, gifts, grants, and honoraria.

The database was created to shed light on these payments, which have been linked in multiple studies to more prescribing of a particular drug or more use of a particular device.

The JAMA review appeared to show that with the exception of the pandemic year, the relationships have more or less stayed the same since Open Payments began.

“There’s been no sea change, no massive shift in how these interactions are happening,” said Deborah C. Marshall, MD, assistant professor in the Department of Radiation Oncology at the Icahn School of Medicine at Mount Sinai in New York City, who has studied industry payments.

“There’s no suggestion that anything is really changing other than that’s there is transparency,” said Robert Steinbrook, MD, director of the Health Research Group at Public Citizen.

Still, Dr. Steinbrook told this news organization, “it’s better to know this than to not know this.”

The unchanging nature of industry-physician relationships “suggests that to reduce the volume and magnitude of payments, more would need to be done,” he said.

“Really, this should be banned. Doctors should not be allowed to get gifts from pharmaceutical companies,” said Adriane Fugh-Berman, MD, professor of pharmacology and physiology at Georgetown University, and director of PharmedOut, a Georgetown-based project that advances evidence-based prescribing and educates healthcare professionals about pharmaceutical marketing practices.

“The interactions wouldn’t be happening unless there was a purpose for them,” said Dr. Marshall. The relationships are “built with intention,” Dr. Marshall told this news organization.
 

Top Earners Range From $195,000 to $4.8 Million

Payments to the median physician over the study period ranged from $0 to $2339, but the mean payment to top earners — those in the top 0.1% — ranged from $194,933 for hospitalists to $4.8 million for orthopedic specialists.

Overall, the median payment was $48 per physician.

But small dollar amounts should not be discounted — even if it’s just a $25-catered lunch — said Aaron Mitchell, MD, a medical oncologist and assistant attending physician at Memorial Sloan Kettering Cancer Center in New York City who has studied industry-physician relationships. “The influence is not just in the dollar value,” Dr. Mitchell told this news organization. “It’s about the time listening to and the time in personal contact with industry representatives that these dollars are a marker for,” he said.

“There’s no such thing as a free lunch,” agreed Dr. Marshall. It’s “pretty well established” that lower-value payments do have influence, which is why academic institutions have established policies that limit gifts and meals and other payments from industry, she said.

Dr. Fugh-Berman said, “the size of the gift doesn’t really matter,” adding that research she conducted had shown that “accepting a meal increased not only the expense of the prescriptions that Medicare physicians wrote but also the number of prescriptions.”
 

Payments Mostly for High-Dollar Products

The top 25 drugs and devices that were related to industry payments tended to be high-cost brand-name products.

The top drug was Janssen’s Xarelto, an anticoagulant first approved in 2011 that costs about $600 a month, according to GoodRx. The drug has had annual sales of $4-$6 billion.

Xarelto was followed by Eliquis, another anticoagulant; Humira, used for a variety of autoimmune conditions including plaque psoriasis, rheumatoid arthritis, Crohn’s disease, and ulcerative colitis; Invokana, Jardiance, and Farxiga, all for type 2 diabetes.

The top medical devices included the da Vinci Surgical System, Mako SmartRobotics, CoreValve Evolut, Natrelle Implants, and Impella, a heart pump that received a US Food and Drug Administration (FDA) warning that it was associated with a heightened risk for death.
 

Industry Influence May Lead to Higher Cost, Poor Quality Care

Multiple studies have shown that payments to physicians tend to lead to increased prescribing and, often, higher costs for Medicare, a health system, or patients.

“I’m sure there are still a lot of physicians out there who think they’re getting away with something, that they can take meals, or they can take consulting fees and not be influenced, but there’s overwhelming data showing that it always influences you,” said Dr. Fugh-Berman.

One study in 2020 that used the Open Payments database found that physicians increase prescribing of the drugs for which they receive payment in the months just after the payment. The authors also showed that physicians who are paid prescribe lower-quality drugs following the payment, “although the magnitude is small and unlikely to be clinically significant.”

Dr. Marshall said that more studies are needed to determine whether quality of care is being affected when a physician prescribes a drug after an industry payment.

For now, there seems to be little appetite among physicians to give up the payments, said Dr. Marshall and others.

Physicians in some specialties see the payments as “an implicit statement about their value,” said Dr. Marshall.

In oncology, having received a lot of payments “gets worn more as a badge of honor,” said Dr. Mitchell.

The clinicians believe that “by collaborating with industry we are providing scientific expertise to help develop the next generation of technology and cures,” Dr. Mitchell said, adding that they see the payments “as a mark of their impact.”

Among the JAMA study authors, Joseph S. Ross, MD, reported that he is a deputy editor of JAMA but was not involved in decisions regarding acceptance of the manuscript or its review. Dr. Ross also reported receiving grants from the FDA, Johnson and Johnson, the Medical Devices Innovation Consortium, the Agency for Healthcare Research and Quality, and the National Heart, Lung, and Blood Institute. He was an expert witness in a qui tam suit alleging violations of the False Claims Act and Anti-Kickback Statute against Biogen that was settled in 2022. Dr. Steinbrook, Dr. Marshall, and Dr. Mitchell reported no relevant financial relationships. Dr. Fugh-Berman reported being an expert witness for plaintiffs in complaints about drug and device marketing practices.

A version of this article appeared on Medscape.com.

A review of the federal Open Payments database found that the pharmaceutical and medical device industry paid physicians $12.1 billion over nearly a decade.

Almost two thirds of eligible physicians — 826,313 doctors — received a payment from a drug or device maker from 2013 to 2022, according to a study published online in JAMA on March 28. Overall, the median payment was $48 per physician.

Orthopedists received the largest amount of payments in aggregate, $1.3 billion, followed by neurologists and psychiatrists at $1.2 billion and cardiologists at $1.29 billion.

Geriatric and nuclear medicine specialists and trauma and pediatric surgeons received the least amount of money in aggregate, and the mean amount paid to a pediatric surgeon in the top 0.1% was just $338,183 over the 9-year study period.

Excluding 2013 (the database was established in August that year), the total value of payments was highest in 2019 at $1.6 billion, up from $1.34 billion in 2014. It was lowest in 2020, the peak year of the COVID-19 pandemic, but dipped to $864 billion that year and rebounded to $1.28 billion in 2022, wrote the authors.

The Open Payments database, administered by the Centers for Medicare & Medicaid Services, requires drug and device makers and group purchasing organizations to report payments made to physicians, including for consulting services, speaking fees, food and beverages, travel and lodging, education, gifts, grants, and honoraria.

The database was created to shed light on these payments, which have been linked in multiple studies to more prescribing of a particular drug or more use of a particular device.

The JAMA review appeared to show that with the exception of the pandemic year, the relationships have more or less stayed the same since Open Payments began.

“There’s been no sea change, no massive shift in how these interactions are happening,” said Deborah C. Marshall, MD, assistant professor in the Department of Radiation Oncology at the Icahn School of Medicine at Mount Sinai in New York City, who has studied industry payments.

“There’s no suggestion that anything is really changing other than that’s there is transparency,” said Robert Steinbrook, MD, director of the Health Research Group at Public Citizen.

Still, Dr. Steinbrook told this news organization, “it’s better to know this than to not know this.”

The unchanging nature of industry-physician relationships “suggests that to reduce the volume and magnitude of payments, more would need to be done,” he said.

“Really, this should be banned. Doctors should not be allowed to get gifts from pharmaceutical companies,” said Adriane Fugh-Berman, MD, professor of pharmacology and physiology at Georgetown University, and director of PharmedOut, a Georgetown-based project that advances evidence-based prescribing and educates healthcare professionals about pharmaceutical marketing practices.

“The interactions wouldn’t be happening unless there was a purpose for them,” said Dr. Marshall. The relationships are “built with intention,” Dr. Marshall told this news organization.
 

Top Earners Range From $195,000 to $4.8 Million

Payments to the median physician over the study period ranged from $0 to $2339, but the mean payment to top earners — those in the top 0.1% — ranged from $194,933 for hospitalists to $4.8 million for orthopedic specialists.

Overall, the median payment was $48 per physician.

But small dollar amounts should not be discounted — even if it’s just a $25-catered lunch — said Aaron Mitchell, MD, a medical oncologist and assistant attending physician at Memorial Sloan Kettering Cancer Center in New York City who has studied industry-physician relationships. “The influence is not just in the dollar value,” Dr. Mitchell told this news organization. “It’s about the time listening to and the time in personal contact with industry representatives that these dollars are a marker for,” he said.

“There’s no such thing as a free lunch,” agreed Dr. Marshall. It’s “pretty well established” that lower-value payments do have influence, which is why academic institutions have established policies that limit gifts and meals and other payments from industry, she said.

Dr. Fugh-Berman said, “the size of the gift doesn’t really matter,” adding that research she conducted had shown that “accepting a meal increased not only the expense of the prescriptions that Medicare physicians wrote but also the number of prescriptions.”
 

Payments Mostly for High-Dollar Products

The top 25 drugs and devices that were related to industry payments tended to be high-cost brand-name products.

The top drug was Janssen’s Xarelto, an anticoagulant first approved in 2011 that costs about $600 a month, according to GoodRx. The drug has had annual sales of $4-$6 billion.

Xarelto was followed by Eliquis, another anticoagulant; Humira, used for a variety of autoimmune conditions including plaque psoriasis, rheumatoid arthritis, Crohn’s disease, and ulcerative colitis; Invokana, Jardiance, and Farxiga, all for type 2 diabetes.

The top medical devices included the da Vinci Surgical System, Mako SmartRobotics, CoreValve Evolut, Natrelle Implants, and Impella, a heart pump that received a US Food and Drug Administration (FDA) warning that it was associated with a heightened risk for death.
 

Industry Influence May Lead to Higher Cost, Poor Quality Care

Multiple studies have shown that payments to physicians tend to lead to increased prescribing and, often, higher costs for Medicare, a health system, or patients.

“I’m sure there are still a lot of physicians out there who think they’re getting away with something, that they can take meals, or they can take consulting fees and not be influenced, but there’s overwhelming data showing that it always influences you,” said Dr. Fugh-Berman.

One study in 2020 that used the Open Payments database found that physicians increase prescribing of the drugs for which they receive payment in the months just after the payment. The authors also showed that physicians who are paid prescribe lower-quality drugs following the payment, “although the magnitude is small and unlikely to be clinically significant.”

Dr. Marshall said that more studies are needed to determine whether quality of care is being affected when a physician prescribes a drug after an industry payment.

For now, there seems to be little appetite among physicians to give up the payments, said Dr. Marshall and others.

Physicians in some specialties see the payments as “an implicit statement about their value,” said Dr. Marshall.

In oncology, having received a lot of payments “gets worn more as a badge of honor,” said Dr. Mitchell.

The clinicians believe that “by collaborating with industry we are providing scientific expertise to help develop the next generation of technology and cures,” Dr. Mitchell said, adding that they see the payments “as a mark of their impact.”

Among the JAMA study authors, Joseph S. Ross, MD, reported that he is a deputy editor of JAMA but was not involved in decisions regarding acceptance of the manuscript or its review. Dr. Ross also reported receiving grants from the FDA, Johnson and Johnson, the Medical Devices Innovation Consortium, the Agency for Healthcare Research and Quality, and the National Heart, Lung, and Blood Institute. He was an expert witness in a qui tam suit alleging violations of the False Claims Act and Anti-Kickback Statute against Biogen that was settled in 2022. Dr. Steinbrook, Dr. Marshall, and Dr. Mitchell reported no relevant financial relationships. Dr. Fugh-Berman reported being an expert witness for plaintiffs in complaints about drug and device marketing practices.

A version of this article appeared on Medscape.com.

Short-term exposure to high outdoor temperatures is associated with an increased inflammatory response and reduction in infection-fighting cells, new research showed.

In this study, blood work from volunteers was examined for immune biomarkers, and the findings mapped against environmental data.

“With rising global temperatures, the association between heat exposure and a temporarily weakened response from the immune system is a concern because temperature and humidity are known to be important environmental drivers of infectious, airborne disease transmission,” lead author Daniel W. Riggs, PhD, with the Christina Lee Brown Envirome Institute, University of Louisville in Louisville, Kentucky, said in a news release.

“In this study, even exposure to relatively modest increases in temperature were associated with acute changes in immune system functioning indexed by low-grade inflammation known to be linked to cardiovascular disorders, as well as potential secondary effects on the ability to optimally protect against infection,” said Rosalind J. Wright, MD, MPH, who wasn’t involved in the study.

“Further elucidation of the effects of both acute and more prolonged heat exposures (heat waves) on immune signaling will be important given potential broad health implications beyond the heart,” said Dr. Wright, dean of public health and professor and chair, Department of Public Health, Mount Sinai Health System.

The study was presented at the American Heart Association (AHA) Epidemiology and Prevention | Lifestyle and Cardiometabolic Scientific Sessions 2024.

High Temps Hard on Multiple Organs

Extreme-heat events have been shown to increase mortality, and excessive deaths due to heat waves are overwhelmingly cardiovascular in origin. Many prior studies only considered ambient temperature, which fails to capture the actual heat stress experienced by individuals, Dr. Riggs and colleagues wrote.

They designed their study to gauge how short-term heat exposures are related to markers of inflammation and the immune response.

They recruited 624 adults (mean age 49 years, 59% women) from a neighborhood in Louisville during the summer months, when median temperatures over 24 hours were 24.5 °C (76 °F).

They obtained blood samples to measure circulating cytokines and immune cells during clinic visits. Heat metrics, collected on the same day as blood draws, included 24-hour averages of temperature, net effective temperature, and the Universal Thermal Climate Index (UTCI), a metric that incorporates temperature, humidity, wind speed, and ultraviolet radiation, to determine the physiological comfort of the human body under specific weather conditions.

The results were adjusted for multiple factors, including sex, age, race, education, body mass index, smoking status, anti-inflammatory medication use, and daily air pollution (PM 2.5).

In adjusted analyses, for every five-degree increase in UTCI, there was an increase in levels of several inflammatory markers, including monocytes (4.2%), eosinophils (9.5%), natural killer T cells (9.9%), and tumor necrosis factor-alpha (7.0%) and a decrease in infection-fighting B cells (−6.8%).

Study Raises Important Questions

“We’re finding that heat is associated with health effects across a wide range of organ systems and outcomes, but this study helps start to get at the ‘how,’” said Perry E. Sheffield, MD, MPH, with the Departments of Pediatrics and Environmental Medicine and Public Health, Icahn School of Medicine at Mount Sinai in New York City, who wasn’t involved in the study.

Dr. Sheffield said the study raises “important questions like, Does the timing of heat exposure matter (going in and out of air-conditioned spaces for example)? and Could some people be more vulnerable than others based on things like what they eat, whether they exercise, or their genetics?”

The study comes on the heels of a report released earlier this month from the World Meteorological Organization noting that climate change indicators reached record levels in 2023.

“The most critical challenges facing medicine are occurring at the intersection of climate and health, underscoring the urgent need to understand how climate-related factors, such as exposure to more extreme temperatures, shift key regulatory systems in our bodies to contribute to disease,” Dr. Wright told this news organization.

The study was supported by grants from the National Institute of Environmental Health Sciences. Dr. Riggs, Dr. Wright, and Sheffield had no relevant disclosures.

A version of this article appeared on Medscape.com.

Short-term exposure to high outdoor temperatures is associated with an increased inflammatory response and reduction in infection-fighting cells, new research showed.

In this study, blood work from volunteers was examined for immune biomarkers, and the findings mapped against environmental data.

“With rising global temperatures, the association between heat exposure and a temporarily weakened response from the immune system is a concern because temperature and humidity are known to be important environmental drivers of infectious, airborne disease transmission,” lead author Daniel W. Riggs, PhD, with the Christina Lee Brown Envirome Institute, University of Louisville in Louisville, Kentucky, said in a news release.

“In this study, even exposure to relatively modest increases in temperature were associated with acute changes in immune system functioning indexed by low-grade inflammation known to be linked to cardiovascular disorders, as well as potential secondary effects on the ability to optimally protect against infection,” said Rosalind J. Wright, MD, MPH, who wasn’t involved in the study.

“Further elucidation of the effects of both acute and more prolonged heat exposures (heat waves) on immune signaling will be important given potential broad health implications beyond the heart,” said Dr. Wright, dean of public health and professor and chair, Department of Public Health, Mount Sinai Health System.

The study was presented at the American Heart Association (AHA) Epidemiology and Prevention | Lifestyle and Cardiometabolic Scientific Sessions 2024.

High Temps Hard on Multiple Organs

Extreme-heat events have been shown to increase mortality, and excessive deaths due to heat waves are overwhelmingly cardiovascular in origin. Many prior studies only considered ambient temperature, which fails to capture the actual heat stress experienced by individuals, Dr. Riggs and colleagues wrote.

They designed their study to gauge how short-term heat exposures are related to markers of inflammation and the immune response.

They recruited 624 adults (mean age 49 years, 59% women) from a neighborhood in Louisville during the summer months, when median temperatures over 24 hours were 24.5 °C (76 °F).

They obtained blood samples to measure circulating cytokines and immune cells during clinic visits. Heat metrics, collected on the same day as blood draws, included 24-hour averages of temperature, net effective temperature, and the Universal Thermal Climate Index (UTCI), a metric that incorporates temperature, humidity, wind speed, and ultraviolet radiation, to determine the physiological comfort of the human body under specific weather conditions.

The results were adjusted for multiple factors, including sex, age, race, education, body mass index, smoking status, anti-inflammatory medication use, and daily air pollution (PM 2.5).

In adjusted analyses, for every five-degree increase in UTCI, there was an increase in levels of several inflammatory markers, including monocytes (4.2%), eosinophils (9.5%), natural killer T cells (9.9%), and tumor necrosis factor-alpha (7.0%) and a decrease in infection-fighting B cells (−6.8%).

Study Raises Important Questions

“We’re finding that heat is associated with health effects across a wide range of organ systems and outcomes, but this study helps start to get at the ‘how,’” said Perry E. Sheffield, MD, MPH, with the Departments of Pediatrics and Environmental Medicine and Public Health, Icahn School of Medicine at Mount Sinai in New York City, who wasn’t involved in the study.

Dr. Sheffield said the study raises “important questions like, Does the timing of heat exposure matter (going in and out of air-conditioned spaces for example)? and Could some people be more vulnerable than others based on things like what they eat, whether they exercise, or their genetics?”

The study comes on the heels of a report released earlier this month from the World Meteorological Organization noting that climate change indicators reached record levels in 2023.

“The most critical challenges facing medicine are occurring at the intersection of climate and health, underscoring the urgent need to understand how climate-related factors, such as exposure to more extreme temperatures, shift key regulatory systems in our bodies to contribute to disease,” Dr. Wright told this news organization.

The study was supported by grants from the National Institute of Environmental Health Sciences. Dr. Riggs, Dr. Wright, and Sheffield had no relevant disclosures.

A version of this article appeared on Medscape.com.

Short-term exposure to high outdoor temperatures is associated with an increased inflammatory response and reduction in infection-fighting cells, new research showed.

In this study, blood work from volunteers was examined for immune biomarkers, and the findings mapped against environmental data.

“With rising global temperatures, the association between heat exposure and a temporarily weakened response from the immune system is a concern because temperature and humidity are known to be important environmental drivers of infectious, airborne disease transmission,” lead author Daniel W. Riggs, PhD, with the Christina Lee Brown Envirome Institute, University of Louisville in Louisville, Kentucky, said in a news release.

“In this study, even exposure to relatively modest increases in temperature were associated with acute changes in immune system functioning indexed by low-grade inflammation known to be linked to cardiovascular disorders, as well as potential secondary effects on the ability to optimally protect against infection,” said Rosalind J. Wright, MD, MPH, who wasn’t involved in the study.

“Further elucidation of the effects of both acute and more prolonged heat exposures (heat waves) on immune signaling will be important given potential broad health implications beyond the heart,” said Dr. Wright, dean of public health and professor and chair, Department of Public Health, Mount Sinai Health System.

The study was presented at the American Heart Association (AHA) Epidemiology and Prevention | Lifestyle and Cardiometabolic Scientific Sessions 2024.

High Temps Hard on Multiple Organs

Extreme-heat events have been shown to increase mortality, and excessive deaths due to heat waves are overwhelmingly cardiovascular in origin. Many prior studies only considered ambient temperature, which fails to capture the actual heat stress experienced by individuals, Dr. Riggs and colleagues wrote.

They designed their study to gauge how short-term heat exposures are related to markers of inflammation and the immune response.

They recruited 624 adults (mean age 49 years, 59% women) from a neighborhood in Louisville during the summer months, when median temperatures over 24 hours were 24.5 °C (76 °F).

They obtained blood samples to measure circulating cytokines and immune cells during clinic visits. Heat metrics, collected on the same day as blood draws, included 24-hour averages of temperature, net effective temperature, and the Universal Thermal Climate Index (UTCI), a metric that incorporates temperature, humidity, wind speed, and ultraviolet radiation, to determine the physiological comfort of the human body under specific weather conditions.

The results were adjusted for multiple factors, including sex, age, race, education, body mass index, smoking status, anti-inflammatory medication use, and daily air pollution (PM 2.5).

In adjusted analyses, for every five-degree increase in UTCI, there was an increase in levels of several inflammatory markers, including monocytes (4.2%), eosinophils (9.5%), natural killer T cells (9.9%), and tumor necrosis factor-alpha (7.0%) and a decrease in infection-fighting B cells (−6.8%).

Study Raises Important Questions

“We’re finding that heat is associated with health effects across a wide range of organ systems and outcomes, but this study helps start to get at the ‘how,’” said Perry E. Sheffield, MD, MPH, with the Departments of Pediatrics and Environmental Medicine and Public Health, Icahn School of Medicine at Mount Sinai in New York City, who wasn’t involved in the study.

Dr. Sheffield said the study raises “important questions like, Does the timing of heat exposure matter (going in and out of air-conditioned spaces for example)? and Could some people be more vulnerable than others based on things like what they eat, whether they exercise, or their genetics?”

The study comes on the heels of a report released earlier this month from the World Meteorological Organization noting that climate change indicators reached record levels in 2023.

“The most critical challenges facing medicine are occurring at the intersection of climate and health, underscoring the urgent need to understand how climate-related factors, such as exposure to more extreme temperatures, shift key regulatory systems in our bodies to contribute to disease,” Dr. Wright told this news organization.

The study was supported by grants from the National Institute of Environmental Health Sciences. Dr. Riggs, Dr. Wright, and Sheffield had no relevant disclosures.

A version of this article appeared on Medscape.com.

Experts worry a recent rise in long COVID cases — fueled by a spike in winter holiday infections and a decline in masking and other measures — could continue into this year.

A sudden rise in long COVID in January has persisted into a second month. About 17.6% of those surveyed by the Census Bureau in January said they have experienced long COVID. The number for February was 17.4.

Compare these new numbers to October 2023 and earlier, when long COVID numbers hovered between 14% and 15% of the US adult population as far back as June 2022.

The Census Bureau and the Centers for Disease Control and Prevention (CDC) regularly query about 70,000 people as part of its ongoing Pulse Survey.

It’s Not Just the Federal Numbers

Independently, advocates, researchers, and clinicians also reported seeing an increase in the number of people who have developed long COVID after a second or third infection.

John Baratta, MD, who runs the COVID Recovery Clinic at the University of North Carolina, said the increase is related to a higher rate of acute cases in the fall and winter of 2023.

In January, the percentage of North Carolinians reporting ever having had long COVD jumped from 12.5% to 20.2% in January and fell to 16.8% in February.

At the same time, many cases are either undetected or unreported by people who tested positive for COVID-19 at home or are not aware they have had it.

Hannah Davis, a member of the Patient-Led Research Collaborative, also linked the increase in long COVID to the wave of new infections at the end of 2023 and the start of 2024.

“It’s absolutely real,” she said via email. “There have been many new cases in the past few months, and we see those new folks in our communities as well.”

Wastewater Remains the Best Indicator

“This results in many cases of COVID flying under the radar,” Dr. Baratta said. “However, we do know from the wastewater monitoring that there was a pretty substantial rise.”

Testing wastewater for COVID levels is becoming one of the most reliable measures of estimating infection, he said. Nationally, viral measure of wastewater followed a similar path: The viral rate started creeping up in October and peaked on December 30, according to CDC measures.

RNA extracted from concentrated wastewater samples offer a good measure of SARS-CoV-2 in the community. In North Carolina and elsewhere, the state measures the virus by calculating gene copies in wastewater per capita — how many for each resident. For most of 2023, North Carolina reported fewer than 10 million viral gene copies per state resident. In late July, that number shot up to 25 million and reached 71 million per capita in March 2023 before starting to go down.

Repeat Infections, Vaccine Apathy Driving Numbers

Dr. Baratta said COVID remains a problem in rural areas. In Maine, wastewater virus counts have been much higher than the national average. There, the percentage of people who reported currently experiencing long COVID rose from 5.7% in October to 9.2% in January. The percentage reporting ever experiencing long COVID rose from 13.8% to 21% in that period.

Other factors play a role. Dr. Baratta said he is seeing patients with long COVID who have refused the vaccine or developed long COVID after a second or third infection.

He said he thinks that attitudes toward the pandemic have resulted in relaxed protection and prevention efforts.

“There is low booster vaccination rate and additional masking is utilized less that before,” he said. About 20% of the population has received the latest vaccine booster, according to the Kaiser Family Foundation.

The increase in long COVID has many causes including “infection, reinfection (eg, people getting COVID after a second, third, or fourth infection), low vaccination rates, waning immunity, and decline in the use of antivirals (such as Paxlovid),” said Ziyad Al-Aly, MD, chief of research at Veterans Affairs St. Louis Health Care and clinical epidemiologist at Washington University in St. Louis, St. Louis, Missouri.

“All of these could contribute to the rise in burden of long COVID,” he said.

Not all states reported an increase. Massachusetts and Hawaii saw long COVD rates drop slightly, according to the CDC.

A version of this article appeared on Medscape.com.

Experts worry a recent rise in long COVID cases — fueled by a spike in winter holiday infections and a decline in masking and other measures — could continue into this year.

A sudden rise in long COVID in January has persisted into a second month. About 17.6% of those surveyed by the Census Bureau in January said they have experienced long COVID. The number for February was 17.4.

Compare these new numbers to October 2023 and earlier, when long COVID numbers hovered between 14% and 15% of the US adult population as far back as June 2022.

The Census Bureau and the Centers for Disease Control and Prevention (CDC) regularly query about 70,000 people as part of its ongoing Pulse Survey.

It’s Not Just the Federal Numbers

Independently, advocates, researchers, and clinicians also reported seeing an increase in the number of people who have developed long COVID after a second or third infection.

John Baratta, MD, who runs the COVID Recovery Clinic at the University of North Carolina, said the increase is related to a higher rate of acute cases in the fall and winter of 2023.

In January, the percentage of North Carolinians reporting ever having had long COVD jumped from 12.5% to 20.2% in January and fell to 16.8% in February.

At the same time, many cases are either undetected or unreported by people who tested positive for COVID-19 at home or are not aware they have had it.

Hannah Davis, a member of the Patient-Led Research Collaborative, also linked the increase in long COVID to the wave of new infections at the end of 2023 and the start of 2024.

“It’s absolutely real,” she said via email. “There have been many new cases in the past few months, and we see those new folks in our communities as well.”

Wastewater Remains the Best Indicator

“This results in many cases of COVID flying under the radar,” Dr. Baratta said. “However, we do know from the wastewater monitoring that there was a pretty substantial rise.”

Testing wastewater for COVID levels is becoming one of the most reliable measures of estimating infection, he said. Nationally, viral measure of wastewater followed a similar path: The viral rate started creeping up in October and peaked on December 30, according to CDC measures.

RNA extracted from concentrated wastewater samples offer a good measure of SARS-CoV-2 in the community. In North Carolina and elsewhere, the state measures the virus by calculating gene copies in wastewater per capita — how many for each resident. For most of 2023, North Carolina reported fewer than 10 million viral gene copies per state resident. In late July, that number shot up to 25 million and reached 71 million per capita in March 2023 before starting to go down.

Repeat Infections, Vaccine Apathy Driving Numbers

Dr. Baratta said COVID remains a problem in rural areas. In Maine, wastewater virus counts have been much higher than the national average. There, the percentage of people who reported currently experiencing long COVID rose from 5.7% in October to 9.2% in January. The percentage reporting ever experiencing long COVID rose from 13.8% to 21% in that period.

Other factors play a role. Dr. Baratta said he is seeing patients with long COVID who have refused the vaccine or developed long COVID after a second or third infection.

He said he thinks that attitudes toward the pandemic have resulted in relaxed protection and prevention efforts.

“There is low booster vaccination rate and additional masking is utilized less that before,” he said. About 20% of the population has received the latest vaccine booster, according to the Kaiser Family Foundation.

The increase in long COVID has many causes including “infection, reinfection (eg, people getting COVID after a second, third, or fourth infection), low vaccination rates, waning immunity, and decline in the use of antivirals (such as Paxlovid),” said Ziyad Al-Aly, MD, chief of research at Veterans Affairs St. Louis Health Care and clinical epidemiologist at Washington University in St. Louis, St. Louis, Missouri.

“All of these could contribute to the rise in burden of long COVID,” he said.

Not all states reported an increase. Massachusetts and Hawaii saw long COVD rates drop slightly, according to the CDC.

A version of this article appeared on Medscape.com.

Experts worry a recent rise in long COVID cases — fueled by a spike in winter holiday infections and a decline in masking and other measures — could continue into this year.

A sudden rise in long COVID in January has persisted into a second month. About 17.6% of those surveyed by the Census Bureau in January said they have experienced long COVID. The number for February was 17.4.

Compare these new numbers to October 2023 and earlier, when long COVID numbers hovered between 14% and 15% of the US adult population as far back as June 2022.

The Census Bureau and the Centers for Disease Control and Prevention (CDC) regularly query about 70,000 people as part of its ongoing Pulse Survey.

It’s Not Just the Federal Numbers

Independently, advocates, researchers, and clinicians also reported seeing an increase in the number of people who have developed long COVID after a second or third infection.

John Baratta, MD, who runs the COVID Recovery Clinic at the University of North Carolina, said the increase is related to a higher rate of acute cases in the fall and winter of 2023.

In January, the percentage of North Carolinians reporting ever having had long COVD jumped from 12.5% to 20.2% in January and fell to 16.8% in February.

At the same time, many cases are either undetected or unreported by people who tested positive for COVID-19 at home or are not aware they have had it.

Hannah Davis, a member of the Patient-Led Research Collaborative, also linked the increase in long COVID to the wave of new infections at the end of 2023 and the start of 2024.

“It’s absolutely real,” she said via email. “There have been many new cases in the past few months, and we see those new folks in our communities as well.”

Wastewater Remains the Best Indicator

“This results in many cases of COVID flying under the radar,” Dr. Baratta said. “However, we do know from the wastewater monitoring that there was a pretty substantial rise.”

Testing wastewater for COVID levels is becoming one of the most reliable measures of estimating infection, he said. Nationally, viral measure of wastewater followed a similar path: The viral rate started creeping up in October and peaked on December 30, according to CDC measures.

RNA extracted from concentrated wastewater samples offer a good measure of SARS-CoV-2 in the community. In North Carolina and elsewhere, the state measures the virus by calculating gene copies in wastewater per capita — how many for each resident. For most of 2023, North Carolina reported fewer than 10 million viral gene copies per state resident. In late July, that number shot up to 25 million and reached 71 million per capita in March 2023 before starting to go down.

Repeat Infections, Vaccine Apathy Driving Numbers

Dr. Baratta said COVID remains a problem in rural areas. In Maine, wastewater virus counts have been much higher than the national average. There, the percentage of people who reported currently experiencing long COVID rose from 5.7% in October to 9.2% in January. The percentage reporting ever experiencing long COVID rose from 13.8% to 21% in that period.

Other factors play a role. Dr. Baratta said he is seeing patients with long COVID who have refused the vaccine or developed long COVID after a second or third infection.

He said he thinks that attitudes toward the pandemic have resulted in relaxed protection and prevention efforts.

“There is low booster vaccination rate and additional masking is utilized less that before,” he said. About 20% of the population has received the latest vaccine booster, according to the Kaiser Family Foundation.

The increase in long COVID has many causes including “infection, reinfection (eg, people getting COVID after a second, third, or fourth infection), low vaccination rates, waning immunity, and decline in the use of antivirals (such as Paxlovid),” said Ziyad Al-Aly, MD, chief of research at Veterans Affairs St. Louis Health Care and clinical epidemiologist at Washington University in St. Louis, St. Louis, Missouri.

“All of these could contribute to the rise in burden of long COVID,” he said.

Not all states reported an increase. Massachusetts and Hawaii saw long COVD rates drop slightly, according to the CDC.

A version of this article appeared on Medscape.com.

TOPLINE:

A study involving more than 260,000 patients found that neither text messages nor reminders in patient portals significantly increased rates of influenza vaccination.

METHODOLOGY:

• The study was conducted from September 2022 to April 2023 in the University of California, Los Angeles (UCLA) health system, involving 262,085 patients across 79 primary care practices.
• Patients were randomly assigned to one of three groups: A control group that received usual care, a group that received reminders through the patient portal, and a group that received reminders via text message.
• The primary outcome was the influenza vaccination rate by April 30, 2023, including vaccinations from pharmacies and other sources.

TAKEAWAY:

• Neither intervention significantly improved influenza vaccination rates, which remained around 47% for all the groups.
• Preappointment text reminders appeared to have a slight effect on unvaccinated patients who had scheduled appointments, suggesting potential for targeted use in this population, according to the researchers.

IN PRACTICE:

“Health systems should consider the potential opportunity costs of sending reminders for influenza vaccination and may decide on other, more intensive interventions, such as improving access to vaccinations (eg, Saturday or after-hour clinics) or communication training for clinicians to address vaccine hesitancy,” the authors of the study wrote.

SOURCE:

The study was led by Peter G. Szilagyi, MD, MPH, with the Department of Pediatrics at UCLA Mattel Children’s Hospital, University of California, Los Angeles. It was published online in JAMA Internal Medicine.

LIMITATIONS:

The study was confined to a single health system and did not assess patients’ reasons for not getting vaccinated.

DISCLOSURES:

The study was supported by grants from the National Institutes of Health. Coauthors disclosed financial ties to pharmacy and pharmaceutical companies and the Pediatric Infectious Disease Society.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

A version of this article appeared on Medscape.com.

TOPLINE:

A study involving more than 260,000 patients found that neither text messages nor reminders in patient portals significantly increased rates of influenza vaccination.

METHODOLOGY:

• The study was conducted from September 2022 to April 2023 in the University of California, Los Angeles (UCLA) health system, involving 262,085 patients across 79 primary care practices.
• Patients were randomly assigned to one of three groups: A control group that received usual care, a group that received reminders through the patient portal, and a group that received reminders via text message.
• The primary outcome was the influenza vaccination rate by April 30, 2023, including vaccinations from pharmacies and other sources.

TAKEAWAY:

• Neither intervention significantly improved influenza vaccination rates, which remained around 47% for all the groups.
• Preappointment text reminders appeared to have a slight effect on unvaccinated patients who had scheduled appointments, suggesting potential for targeted use in this population, according to the researchers.

IN PRACTICE:

“Health systems should consider the potential opportunity costs of sending reminders for influenza vaccination and may decide on other, more intensive interventions, such as improving access to vaccinations (eg, Saturday or after-hour clinics) or communication training for clinicians to address vaccine hesitancy,” the authors of the study wrote.

SOURCE:

The study was led by Peter G. Szilagyi, MD, MPH, with the Department of Pediatrics at UCLA Mattel Children’s Hospital, University of California, Los Angeles. It was published online in JAMA Internal Medicine.

LIMITATIONS:

The study was confined to a single health system and did not assess patients’ reasons for not getting vaccinated.

DISCLOSURES:

The study was supported by grants from the National Institutes of Health. Coauthors disclosed financial ties to pharmacy and pharmaceutical companies and the Pediatric Infectious Disease Society.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

A version of this article appeared on Medscape.com.

TOPLINE:

A study involving more than 260,000 patients found that neither text messages nor reminders in patient portals significantly increased rates of influenza vaccination.

METHODOLOGY:

• The study was conducted from September 2022 to April 2023 in the University of California, Los Angeles (UCLA) health system, involving 262,085 patients across 79 primary care practices.
• Patients were randomly assigned to one of three groups: A control group that received usual care, a group that received reminders through the patient portal, and a group that received reminders via text message.
• The primary outcome was the influenza vaccination rate by April 30, 2023, including vaccinations from pharmacies and other sources.

TAKEAWAY:

• Neither intervention significantly improved influenza vaccination rates, which remained around 47% for all the groups.
• Preappointment text reminders appeared to have a slight effect on unvaccinated patients who had scheduled appointments, suggesting potential for targeted use in this population, according to the researchers.

IN PRACTICE:

“Health systems should consider the potential opportunity costs of sending reminders for influenza vaccination and may decide on other, more intensive interventions, such as improving access to vaccinations (eg, Saturday or after-hour clinics) or communication training for clinicians to address vaccine hesitancy,” the authors of the study wrote.

SOURCE:

The study was led by Peter G. Szilagyi, MD, MPH, with the Department of Pediatrics at UCLA Mattel Children’s Hospital, University of California, Los Angeles. It was published online in JAMA Internal Medicine.

LIMITATIONS:

The study was confined to a single health system and did not assess patients’ reasons for not getting vaccinated.

DISCLOSURES:

The study was supported by grants from the National Institutes of Health. Coauthors disclosed financial ties to pharmacy and pharmaceutical companies and the Pediatric Infectious Disease Society.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

A version of this article appeared on Medscape.com.

Data from the Minnesota Department of Health (MDH) underscore the often poor reliability of a clinical diagnosis of varicella (chickenpox) in children without laboratory test confirmation, according to a report featured in the Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report.

Only about half of clinically diagnosed varicella cases — cases diagnosed by examining rashes without laboratory testing — were positive for the varicella-zoster virus (VZV), suggesting lab testing is important to avoid consequences such as children being kept out of school longer than necessary.

Clinical diagnosis continues to be the primary method for diagnosing varicella, said authors of the report, led by Alison Ruprecht, MPH, a state epidemiologist with the MDH. But the signs and symptoms of those who have received the varicella vaccine (including fewer skin lesions, mostly maculopapular) make it difficult to diagnose.
 

Minnesota Offers Free Tests

In December 2016, the MDH expanded polymerase chain reaction (PCR) laboratory testing for varicella in the state. The program reached out to clinicians through newsletters, webinars, advisories, and conferences describing the importance of lab testing when clinicians suspect a patient’s rash is varicella. The department also offered free testing at MDH Public Health Laboratory (PHL) through an agreement with the CDC and follow-up, if needed, with clinicians on testing practices.

MDH also provided specimen collection kits (containing a collection swab for vesicular fluid and slides for collection of scabs or scraping of maculopapular lesions) to clinics. Free testing was available for people with suspected varicella, including those who had been clinically diagnosed, or people who self-reported suspected varicella or whose school or child care reported the suspected cases. In addition to testing for varicella, MDH-PHL performed PCR testing for herpes simplex virus 1 (HSV-1), herpes simplex virus 2 (HSV-2), and enterovirus on all samples.

The state then saw lab-confirmed varicella cases double from 17% (235 of 1,426) during January 2013–November 2016 to 36% (619 of 1,717) during December 2016–March 2023 (P < .001).

During December 2016–March 2023, MDH-PHL tested specimens for 420 patients with suspected varicella; the median patient age was 5 years (range = 0-68 years). Of those, 23% provided specimens collected at home.
 

Clinical Diagnosis Versus Lab Test Confirmation

The researchers found that among 208 patients receiving a clinical diagnosis of varicella after only examination at a medical facility, fewer than half (45%) had positive varicella-zoster virus (VZV) lab test results. VZV detection was 66% lower in those who received varicella vaccine compared with those who did not.

The researchers acknowledged that outreach, at-home specimen collection, and free testing likely increased lab testing numbers.

They added that, “This increase in varicella testing likely also contributed to an increase in appropriate clinical management and school exclusion recommendations for suspect varicella cases.

“Clinicians should incorporate routine laboratory testing whenever varicella is suspected,” the researchers wrote. “Public health and school health professionals should emphasize the importance of laboratory confirmation in their recommendations to clinicians and parents.”
 

Presentation May Also Be Different in Immunocompromised

Sam Dominguez, MD, infectious disease specialist at Children’s Colorado in Aurora, who was not part of the research, said in addition to presentation being harder to recognize in those who are vaccinated, varicella is harder to diagnose in the immunocompromised population, where the rash may not be as prominent or more localized or appear in any number of atypical presentations.

In addition, he said, clinicians don’t see many cases these days. “Providers aren’t as familiar with what varicella looks like, especially younger providers who weren’t trained in the prevaccination era,” he said.

Cost is often an issue with lab testing as well as turn-around time and access, he said, and those factors can be barriers.

Dr. Dominguez said some classic presentations are easily diagnosed as varicella. “If you have a normal, healthy kid, who you’re seeing in the outpatient world who presents with a very classic rash for chickenpox, I don’t think laboratory testing is necessarily warranted in that scenario.”

But when clinicians aren’t confident in their diagnosis, “I think in those scenarios, testing can be very helpful in terms of management from a treatment standpoint as well as a potential infection control standpoint,” he said.

The authors reported no relevant financial relationships. Dr. Dominguez is a consultant for diagnostic companies Karius and BioFire. He has grant support from Pfizer and BioFire.

Data from the Minnesota Department of Health (MDH) underscore the often poor reliability of a clinical diagnosis of varicella (chickenpox) in children without laboratory test confirmation, according to a report featured in the Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report.

Only about half of clinically diagnosed varicella cases — cases diagnosed by examining rashes without laboratory testing — were positive for the varicella-zoster virus (VZV), suggesting lab testing is important to avoid consequences such as children being kept out of school longer than necessary.

Clinical diagnosis continues to be the primary method for diagnosing varicella, said authors of the report, led by Alison Ruprecht, MPH, a state epidemiologist with the MDH. But the signs and symptoms of those who have received the varicella vaccine (including fewer skin lesions, mostly maculopapular) make it difficult to diagnose.
 

Minnesota Offers Free Tests

In December 2016, the MDH expanded polymerase chain reaction (PCR) laboratory testing for varicella in the state. The program reached out to clinicians through newsletters, webinars, advisories, and conferences describing the importance of lab testing when clinicians suspect a patient’s rash is varicella. The department also offered free testing at MDH Public Health Laboratory (PHL) through an agreement with the CDC and follow-up, if needed, with clinicians on testing practices.

MDH also provided specimen collection kits (containing a collection swab for vesicular fluid and slides for collection of scabs or scraping of maculopapular lesions) to clinics. Free testing was available for people with suspected varicella, including those who had been clinically diagnosed, or people who self-reported suspected varicella or whose school or child care reported the suspected cases. In addition to testing for varicella, MDH-PHL performed PCR testing for herpes simplex virus 1 (HSV-1), herpes simplex virus 2 (HSV-2), and enterovirus on all samples.

The state then saw lab-confirmed varicella cases double from 17% (235 of 1,426) during January 2013–November 2016 to 36% (619 of 1,717) during December 2016–March 2023 (P < .001).

During December 2016–March 2023, MDH-PHL tested specimens for 420 patients with suspected varicella; the median patient age was 5 years (range = 0-68 years). Of those, 23% provided specimens collected at home.
 

Clinical Diagnosis Versus Lab Test Confirmation

The researchers found that among 208 patients receiving a clinical diagnosis of varicella after only examination at a medical facility, fewer than half (45%) had positive varicella-zoster virus (VZV) lab test results. VZV detection was 66% lower in those who received varicella vaccine compared with those who did not.

The researchers acknowledged that outreach, at-home specimen collection, and free testing likely increased lab testing numbers.

They added that, “This increase in varicella testing likely also contributed to an increase in appropriate clinical management and school exclusion recommendations for suspect varicella cases.

“Clinicians should incorporate routine laboratory testing whenever varicella is suspected,” the researchers wrote. “Public health and school health professionals should emphasize the importance of laboratory confirmation in their recommendations to clinicians and parents.”
 

Presentation May Also Be Different in Immunocompromised

Sam Dominguez, MD, infectious disease specialist at Children’s Colorado in Aurora, who was not part of the research, said in addition to presentation being harder to recognize in those who are vaccinated, varicella is harder to diagnose in the immunocompromised population, where the rash may not be as prominent or more localized or appear in any number of atypical presentations.

In addition, he said, clinicians don’t see many cases these days. “Providers aren’t as familiar with what varicella looks like, especially younger providers who weren’t trained in the prevaccination era,” he said.

Cost is often an issue with lab testing as well as turn-around time and access, he said, and those factors can be barriers.

Dr. Dominguez said some classic presentations are easily diagnosed as varicella. “If you have a normal, healthy kid, who you’re seeing in the outpatient world who presents with a very classic rash for chickenpox, I don’t think laboratory testing is necessarily warranted in that scenario.”

But when clinicians aren’t confident in their diagnosis, “I think in those scenarios, testing can be very helpful in terms of management from a treatment standpoint as well as a potential infection control standpoint,” he said.

The authors reported no relevant financial relationships. Dr. Dominguez is a consultant for diagnostic companies Karius and BioFire. He has grant support from Pfizer and BioFire.

Data from the Minnesota Department of Health (MDH) underscore the often poor reliability of a clinical diagnosis of varicella (chickenpox) in children without laboratory test confirmation, according to a report featured in the Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report.

Only about half of clinically diagnosed varicella cases — cases diagnosed by examining rashes without laboratory testing — were positive for the varicella-zoster virus (VZV), suggesting lab testing is important to avoid consequences such as children being kept out of school longer than necessary.

Clinical diagnosis continues to be the primary method for diagnosing varicella, said authors of the report, led by Alison Ruprecht, MPH, a state epidemiologist with the MDH. But the signs and symptoms of those who have received the varicella vaccine (including fewer skin lesions, mostly maculopapular) make it difficult to diagnose.
 

Minnesota Offers Free Tests

In December 2016, the MDH expanded polymerase chain reaction (PCR) laboratory testing for varicella in the state. The program reached out to clinicians through newsletters, webinars, advisories, and conferences describing the importance of lab testing when clinicians suspect a patient’s rash is varicella. The department also offered free testing at MDH Public Health Laboratory (PHL) through an agreement with the CDC and follow-up, if needed, with clinicians on testing practices.

MDH also provided specimen collection kits (containing a collection swab for vesicular fluid and slides for collection of scabs or scraping of maculopapular lesions) to clinics. Free testing was available for people with suspected varicella, including those who had been clinically diagnosed, or people who self-reported suspected varicella or whose school or child care reported the suspected cases. In addition to testing for varicella, MDH-PHL performed PCR testing for herpes simplex virus 1 (HSV-1), herpes simplex virus 2 (HSV-2), and enterovirus on all samples.

The state then saw lab-confirmed varicella cases double from 17% (235 of 1,426) during January 2013–November 2016 to 36% (619 of 1,717) during December 2016–March 2023 (P < .001).

During December 2016–March 2023, MDH-PHL tested specimens for 420 patients with suspected varicella; the median patient age was 5 years (range = 0-68 years). Of those, 23% provided specimens collected at home.
 

Clinical Diagnosis Versus Lab Test Confirmation

The researchers found that among 208 patients receiving a clinical diagnosis of varicella after only examination at a medical facility, fewer than half (45%) had positive varicella-zoster virus (VZV) lab test results. VZV detection was 66% lower in those who received varicella vaccine compared with those who did not.

The researchers acknowledged that outreach, at-home specimen collection, and free testing likely increased lab testing numbers.

They added that, “This increase in varicella testing likely also contributed to an increase in appropriate clinical management and school exclusion recommendations for suspect varicella cases.

“Clinicians should incorporate routine laboratory testing whenever varicella is suspected,” the researchers wrote. “Public health and school health professionals should emphasize the importance of laboratory confirmation in their recommendations to clinicians and parents.”
 

Presentation May Also Be Different in Immunocompromised

Sam Dominguez, MD, infectious disease specialist at Children’s Colorado in Aurora, who was not part of the research, said in addition to presentation being harder to recognize in those who are vaccinated, varicella is harder to diagnose in the immunocompromised population, where the rash may not be as prominent or more localized or appear in any number of atypical presentations.

In addition, he said, clinicians don’t see many cases these days. “Providers aren’t as familiar with what varicella looks like, especially younger providers who weren’t trained in the prevaccination era,” he said.

Cost is often an issue with lab testing as well as turn-around time and access, he said, and those factors can be barriers.

Dr. Dominguez said some classic presentations are easily diagnosed as varicella. “If you have a normal, healthy kid, who you’re seeing in the outpatient world who presents with a very classic rash for chickenpox, I don’t think laboratory testing is necessarily warranted in that scenario.”

But when clinicians aren’t confident in their diagnosis, “I think in those scenarios, testing can be very helpful in terms of management from a treatment standpoint as well as a potential infection control standpoint,” he said.

The authors reported no relevant financial relationships. Dr. Dominguez is a consultant for diagnostic companies Karius and BioFire. He has grant support from Pfizer and BioFire.

TOPLINE:

Receipt of the bivalent COVID-19 vaccine was not associated with an increased stroke risk in the first 6 weeks after vaccination with either the Pfizer or Moderna vaccines, a new study of Medicare beneficiaries showed.

METHODOLOGY:

• The analysis included 5.4 million people age ≥ 65 years who received either the Pfizer-BioNTech COVID-19 bivalent vaccine or the Moderna bivalent vaccine, or the Pfizer vaccine and a high-dose or adjuvanted concomitant influenza vaccine (ie, administered on the same day).
• A total of 11,001 of the cohort experienced a stroke in the first 90 days after vaccination.
• The main outcome was stroke risk (nonhemorrhagic stroke, transient ischemic attack [TIA], or hemorrhagic stroke) during the 1- to 21-day or 22- to 42-day window after vaccination vs the 43- to 90-day control window.
• The mean age of participants was 74 years, and 56% were female.

TAKEAWAY:

• There was no statistically significant association with either brand of the COVID-19 bivalent vaccine or any of the stroke outcomes during the 1- to 21-day or 22- to 42-day risk window compared with the 43- to 90-day control window (incidence rate ratio [IRR] range, 0.72-1.12).
• Vaccination with COVID-19 bivalent vaccine plus a high-dose or adjuvanted influenza vaccine (n = 4596) was associated with a significantly greater risk for nonhemorrhagic stroke 22-42 days after vaccination with Pfizer-BioNTech (IRR, 1.20; risk difference/100,000 doses, 3.13) and an increase in TIA risk 1-21 days after vaccination with Moderna (IRR, 1.35; risk difference/100,000 doses, 3.33).
• There was a significant association between vaccination with a high-dose or adjuvanted influenza vaccine (n = 21,345) and nonhemorrhagic stroke 22-42 days after vaccination (IRR, 1.09; risk difference/100,000 doses, 1.65).

IN PRACTICE:

“The clinical significance of the risk of stroke after vaccination must be carefully considered together with the significant benefits of receiving an influenza vaccination,” the authors wrote. “Because the framework of the current self-controlled case series study does not compare the populations who were vaccinated vs those who were unvaccinated, it does not account for the reduced rate of severe influenza after vaccination. More studies are needed to better understand the association between high-dose or adjuvanted influenza vaccination and stroke.”

SOURCE:

Yun Lu, PhD, of the Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, was the lead and corresponding author of the study. It was published online on March 19 in JAMA.

LIMITATIONS:

Some stroke cases may have been missed or misclassified. The study included only vaccinated individuals — a population considered to have health-seeking behaviors — which may limit the generalizability of the findings. The study was conducted using COVID-19 bivalent vaccines, which are no longer available.

DISCLOSURES:

This work was funded by the US Food and Drug Administration through an interagency agreement with the Centers for Medicare & Medicaid Services. Dr. Lu reported no relevant financial relationships. The other authors’ disclosures are listed in the original paper.

A version of this article appeared on Medscape.com.

TOPLINE:

Receipt of the bivalent COVID-19 vaccine was not associated with an increased stroke risk in the first 6 weeks after vaccination with either the Pfizer or Moderna vaccines, a new study of Medicare beneficiaries showed.

METHODOLOGY:

• The analysis included 5.4 million people age ≥ 65 years who received either the Pfizer-BioNTech COVID-19 bivalent vaccine or the Moderna bivalent vaccine, or the Pfizer vaccine and a high-dose or adjuvanted concomitant influenza vaccine (ie, administered on the same day).
• A total of 11,001 of the cohort experienced a stroke in the first 90 days after vaccination.
• The main outcome was stroke risk (nonhemorrhagic stroke, transient ischemic attack [TIA], or hemorrhagic stroke) during the 1- to 21-day or 22- to 42-day window after vaccination vs the 43- to 90-day control window.
• The mean age of participants was 74 years, and 56% were female.

TAKEAWAY:

• There was no statistically significant association with either brand of the COVID-19 bivalent vaccine or any of the stroke outcomes during the 1- to 21-day or 22- to 42-day risk window compared with the 43- to 90-day control window (incidence rate ratio [IRR] range, 0.72-1.12).
• Vaccination with COVID-19 bivalent vaccine plus a high-dose or adjuvanted influenza vaccine (n = 4596) was associated with a significantly greater risk for nonhemorrhagic stroke 22-42 days after vaccination with Pfizer-BioNTech (IRR, 1.20; risk difference/100,000 doses, 3.13) and an increase in TIA risk 1-21 days after vaccination with Moderna (IRR, 1.35; risk difference/100,000 doses, 3.33).
• There was a significant association between vaccination with a high-dose or adjuvanted influenza vaccine (n = 21,345) and nonhemorrhagic stroke 22-42 days after vaccination (IRR, 1.09; risk difference/100,000 doses, 1.65).

IN PRACTICE:

“The clinical significance of the risk of stroke after vaccination must be carefully considered together with the significant benefits of receiving an influenza vaccination,” the authors wrote. “Because the framework of the current self-controlled case series study does not compare the populations who were vaccinated vs those who were unvaccinated, it does not account for the reduced rate of severe influenza after vaccination. More studies are needed to better understand the association between high-dose or adjuvanted influenza vaccination and stroke.”

SOURCE:

Yun Lu, PhD, of the Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, was the lead and corresponding author of the study. It was published online on March 19 in JAMA.

LIMITATIONS:

Some stroke cases may have been missed or misclassified. The study included only vaccinated individuals — a population considered to have health-seeking behaviors — which may limit the generalizability of the findings. The study was conducted using COVID-19 bivalent vaccines, which are no longer available.

DISCLOSURES:

This work was funded by the US Food and Drug Administration through an interagency agreement with the Centers for Medicare & Medicaid Services. Dr. Lu reported no relevant financial relationships. The other authors’ disclosures are listed in the original paper.

A version of this article appeared on Medscape.com.

TOPLINE:

Receipt of the bivalent COVID-19 vaccine was not associated with an increased stroke risk in the first 6 weeks after vaccination with either the Pfizer or Moderna vaccines, a new study of Medicare beneficiaries showed.

METHODOLOGY:

• The analysis included 5.4 million people age ≥ 65 years who received either the Pfizer-BioNTech COVID-19 bivalent vaccine or the Moderna bivalent vaccine, or the Pfizer vaccine and a high-dose or adjuvanted concomitant influenza vaccine (ie, administered on the same day).
• A total of 11,001 of the cohort experienced a stroke in the first 90 days after vaccination.
• The main outcome was stroke risk (nonhemorrhagic stroke, transient ischemic attack [TIA], or hemorrhagic stroke) during the 1- to 21-day or 22- to 42-day window after vaccination vs the 43- to 90-day control window.
• The mean age of participants was 74 years, and 56% were female.

TAKEAWAY:

• There was no statistically significant association with either brand of the COVID-19 bivalent vaccine or any of the stroke outcomes during the 1- to 21-day or 22- to 42-day risk window compared with the 43- to 90-day control window (incidence rate ratio [IRR] range, 0.72-1.12).
• Vaccination with COVID-19 bivalent vaccine plus a high-dose or adjuvanted influenza vaccine (n = 4596) was associated with a significantly greater risk for nonhemorrhagic stroke 22-42 days after vaccination with Pfizer-BioNTech (IRR, 1.20; risk difference/100,000 doses, 3.13) and an increase in TIA risk 1-21 days after vaccination with Moderna (IRR, 1.35; risk difference/100,000 doses, 3.33).
• There was a significant association between vaccination with a high-dose or adjuvanted influenza vaccine (n = 21,345) and nonhemorrhagic stroke 22-42 days after vaccination (IRR, 1.09; risk difference/100,000 doses, 1.65).

IN PRACTICE:

“The clinical significance of the risk of stroke after vaccination must be carefully considered together with the significant benefits of receiving an influenza vaccination,” the authors wrote. “Because the framework of the current self-controlled case series study does not compare the populations who were vaccinated vs those who were unvaccinated, it does not account for the reduced rate of severe influenza after vaccination. More studies are needed to better understand the association between high-dose or adjuvanted influenza vaccination and stroke.”

SOURCE:

Yun Lu, PhD, of the Center for Biologics Evaluation and Research, US Food and Drug Administration, Silver Spring, Maryland, was the lead and corresponding author of the study. It was published online on March 19 in JAMA.

LIMITATIONS:

Some stroke cases may have been missed or misclassified. The study included only vaccinated individuals — a population considered to have health-seeking behaviors — which may limit the generalizability of the findings. The study was conducted using COVID-19 bivalent vaccines, which are no longer available.

DISCLOSURES:

This work was funded by the US Food and Drug Administration through an interagency agreement with the Centers for Medicare & Medicaid Services. Dr. Lu reported no relevant financial relationships. The other authors’ disclosures are listed in the original paper.

A version of this article appeared on Medscape.com.

Please note that this is a commentary, an opinion piece: my opinion. The statements here do not necessarily represent those of this news organization or any of the myriad people or institutions that comprise this corner of the human universe.

Some days, speaking as a long-time physician and editor, I wish that there were no such things as race or ethnicity or even geographic origin for that matter. We can’t get away from sex, gender, disability, age, or culture. I’m not sure about religion. I wish people were just people.

But race is deeply embedded in the American experience — an almost invisible but inevitable presence in all of our thoughts and expressions about human activities.

In medical education (for eons it seems) the student has been taught to mention race in the first sentence of a given patient presentation, along with age and sex. In human epidemiologic research, race is almost always a studied variable. In clinical and basic medical research, looking at the impact of race on this, that, or the other is commonplace. “Mixed race not otherwise specified” is ubiquitous in the United States yet blithely ignored by most who tally these statistics. Race is rarely gene-specific. It is more of a social and cultural construct but with plainly visible overt phenotypic markers — an almost infinite mix of daily reality.

Our country, and much of Western civilization in 2024, is based on the principle that all men are created equal, although the originators of that notion were unaware of their own “equity-challenged” situation.

Many organizations, in and out of government, are now understanding, developing, and implementing programs (and thought/language patterns) to socialize diversity, equity, and inclusion (known as DEI) into their culture. It should not be surprising that many who prefer the status quo are not happy with the pressure from this movement and are using whatever methods are available to them to prevent full DEI. Such it always is.

The trusty Copilot from Bing provides these definitions:

• Diversity refers to the presence of variety within the organizational workforce. This includes aspects such as gender, culture, ethnicity, religion, disability, age, and opinion.
• Equity encompasses concepts of fairness and justice. It involves fair compensation, substantive equality, and addressing societal disparities. Equity also considers unique circumstances and adjusts treatment to achieve equal outcomes.
• Inclusion focuses on creating an organizational culture where all employees feel heard, fostering a sense of belonging and integration.

I am more than proud that my old domain of peer-reviewed, primary source, medical (and science) journals is taking a leading role in this noble, necessary, and long overdue movement for medicine.

As the central repository and transmitter of new medical information, including scientific studies, clinical medicine reports, ethics measures, and education, medical journals (including those deemed prestigious) have historically been among the worst offenders in perpetuating non-DEI objectives in their leadership, staffing, focus, instructions for authors, style manuals, and published materials.

This issue came to a head in March 2021 when a JAMA podcast about racism in American medicine was followed by this promotional tweet: “No physician is racist, so how can there be structural racism in health care?”

Reactions and actions were rapid, strong, and decisive. After an interregnum at JAMA, a new editor in chief, Kirsten Bibbins-Domingo, PhD, MD, MAS, was named. She and her large staff of editors and editorial board members from the multijournal JAMA Network joined a worldwide movement of (currently) 56 publishing organizations representing 15,000 journals called the Joint Commitment for Action on Inclusion and Diversity in Publishing.

A recent JAMA editorial with 29 authors describes the entire commitment initiative of publishers-editors. It reports JAMA Network data from 2023 and 2024 from surveys of 455 editors (a 91% response rate) about their own gender (five choices), ethnic origins or geographic ancestry (13 choices), and race (eight choices), demonstrating considerable progress toward DEI goals. The survey’s complex multinational classifications may not jibe with the categorizations used in some countries (too bad that “mixed” is not “mixed in” — a missed opportunity).

This encouraging movement will not fix it all. But when people of certain groups are represented at the table, that point of view is far more likely to make it into the lexicon, language, and omnipresent work products, potentially changing cultural norms. Even the measurement of movement related to disparity in healthcare is marred by frequent variations of data accuracy. More consistency in what to measure can help a lot, and the medical literature can be very influential.

A personal anecdote: When I was a professor at UC Davis in 1978, Allan Bakke, MD, was my student. Some of you will remember the saga of affirmative action on admissions, which was just revisited in the light of a recent decision by the US Supreme Court.

Back in 1978, the dean at UC Davis told me that he kept two file folders on the admission processes in different desk drawers. One categorized all applicants and enrollees by race, and the other did not. Depending on who came to visit and ask questions, he would choose one or the other file to share once he figured out what they were looking for (this is not a joke).

The strength of the current active political pushback against the entire DEI movement has deep roots and should not be underestimated. There will be a lot of to-ing and fro-ing.

French writer Victor Hugo is credited with stating, “There is nothing as powerful as an idea whose time has come.” A majority of Americans, physicians, and other healthcare professionals believe in basic fairness. The time for DEI in all aspects of medicine is now.

Dr. Lundberg, editor in chief of Cancer Commons, disclosed having no relevant financial relationships.

A version of this article appeared on Medscape.com.

Please note that this is a commentary, an opinion piece: my opinion. The statements here do not necessarily represent those of this news organization or any of the myriad people or institutions that comprise this corner of the human universe.

Some days, speaking as a long-time physician and editor, I wish that there were no such things as race or ethnicity or even geographic origin for that matter. We can’t get away from sex, gender, disability, age, or culture. I’m not sure about religion. I wish people were just people.

But race is deeply embedded in the American experience — an almost invisible but inevitable presence in all of our thoughts and expressions about human activities.

In medical education (for eons it seems) the student has been taught to mention race in the first sentence of a given patient presentation, along with age and sex. In human epidemiologic research, race is almost always a studied variable. In clinical and basic medical research, looking at the impact of race on this, that, or the other is commonplace. “Mixed race not otherwise specified” is ubiquitous in the United States yet blithely ignored by most who tally these statistics. Race is rarely gene-specific. It is more of a social and cultural construct but with plainly visible overt phenotypic markers — an almost infinite mix of daily reality.

Our country, and much of Western civilization in 2024, is based on the principle that all men are created equal, although the originators of that notion were unaware of their own “equity-challenged” situation.

Many organizations, in and out of government, are now understanding, developing, and implementing programs (and thought/language patterns) to socialize diversity, equity, and inclusion (known as DEI) into their culture. It should not be surprising that many who prefer the status quo are not happy with the pressure from this movement and are using whatever methods are available to them to prevent full DEI. Such it always is.

The trusty Copilot from Bing provides these definitions:

• Diversity refers to the presence of variety within the organizational workforce. This includes aspects such as gender, culture, ethnicity, religion, disability, age, and opinion.
• Equity encompasses concepts of fairness and justice. It involves fair compensation, substantive equality, and addressing societal disparities. Equity also considers unique circumstances and adjusts treatment to achieve equal outcomes.
• Inclusion focuses on creating an organizational culture where all employees feel heard, fostering a sense of belonging and integration.

I am more than proud that my old domain of peer-reviewed, primary source, medical (and science) journals is taking a leading role in this noble, necessary, and long overdue movement for medicine.

As the central repository and transmitter of new medical information, including scientific studies, clinical medicine reports, ethics measures, and education, medical journals (including those deemed prestigious) have historically been among the worst offenders in perpetuating non-DEI objectives in their leadership, staffing, focus, instructions for authors, style manuals, and published materials.

This issue came to a head in March 2021 when a JAMA podcast about racism in American medicine was followed by this promotional tweet: “No physician is racist, so how can there be structural racism in health care?”

Reactions and actions were rapid, strong, and decisive. After an interregnum at JAMA, a new editor in chief, Kirsten Bibbins-Domingo, PhD, MD, MAS, was named. She and her large staff of editors and editorial board members from the multijournal JAMA Network joined a worldwide movement of (currently) 56 publishing organizations representing 15,000 journals called the Joint Commitment for Action on Inclusion and Diversity in Publishing.

A recent JAMA editorial with 29 authors describes the entire commitment initiative of publishers-editors. It reports JAMA Network data from 2023 and 2024 from surveys of 455 editors (a 91% response rate) about their own gender (five choices), ethnic origins or geographic ancestry (13 choices), and race (eight choices), demonstrating considerable progress toward DEI goals. The survey’s complex multinational classifications may not jibe with the categorizations used in some countries (too bad that “mixed” is not “mixed in” — a missed opportunity).

This encouraging movement will not fix it all. But when people of certain groups are represented at the table, that point of view is far more likely to make it into the lexicon, language, and omnipresent work products, potentially changing cultural norms. Even the measurement of movement related to disparity in healthcare is marred by frequent variations of data accuracy. More consistency in what to measure can help a lot, and the medical literature can be very influential.

A personal anecdote: When I was a professor at UC Davis in 1978, Allan Bakke, MD, was my student. Some of you will remember the saga of affirmative action on admissions, which was just revisited in the light of a recent decision by the US Supreme Court.

Back in 1978, the dean at UC Davis told me that he kept two file folders on the admission processes in different desk drawers. One categorized all applicants and enrollees by race, and the other did not. Depending on who came to visit and ask questions, he would choose one or the other file to share once he figured out what they were looking for (this is not a joke).

The strength of the current active political pushback against the entire DEI movement has deep roots and should not be underestimated. There will be a lot of to-ing and fro-ing.

French writer Victor Hugo is credited with stating, “There is nothing as powerful as an idea whose time has come.” A majority of Americans, physicians, and other healthcare professionals believe in basic fairness. The time for DEI in all aspects of medicine is now.

Dr. Lundberg, editor in chief of Cancer Commons, disclosed having no relevant financial relationships.

A version of this article appeared on Medscape.com.

Please note that this is a commentary, an opinion piece: my opinion. The statements here do not necessarily represent those of this news organization or any of the myriad people or institutions that comprise this corner of the human universe.

Some days, speaking as a long-time physician and editor, I wish that there were no such things as race or ethnicity or even geographic origin for that matter. We can’t get away from sex, gender, disability, age, or culture. I’m not sure about religion. I wish people were just people.

But race is deeply embedded in the American experience — an almost invisible but inevitable presence in all of our thoughts and expressions about human activities.

In medical education (for eons it seems) the student has been taught to mention race in the first sentence of a given patient presentation, along with age and sex. In human epidemiologic research, race is almost always a studied variable. In clinical and basic medical research, looking at the impact of race on this, that, or the other is commonplace. “Mixed race not otherwise specified” is ubiquitous in the United States yet blithely ignored by most who tally these statistics. Race is rarely gene-specific. It is more of a social and cultural construct but with plainly visible overt phenotypic markers — an almost infinite mix of daily reality.

Our country, and much of Western civilization in 2024, is based on the principle that all men are created equal, although the originators of that notion were unaware of their own “equity-challenged” situation.

Many organizations, in and out of government, are now understanding, developing, and implementing programs (and thought/language patterns) to socialize diversity, equity, and inclusion (known as DEI) into their culture. It should not be surprising that many who prefer the status quo are not happy with the pressure from this movement and are using whatever methods are available to them to prevent full DEI. Such it always is.

The trusty Copilot from Bing provides these definitions:

• Diversity refers to the presence of variety within the organizational workforce. This includes aspects such as gender, culture, ethnicity, religion, disability, age, and opinion.
• Equity encompasses concepts of fairness and justice. It involves fair compensation, substantive equality, and addressing societal disparities. Equity also considers unique circumstances and adjusts treatment to achieve equal outcomes.
• Inclusion focuses on creating an organizational culture where all employees feel heard, fostering a sense of belonging and integration.

I am more than proud that my old domain of peer-reviewed, primary source, medical (and science) journals is taking a leading role in this noble, necessary, and long overdue movement for medicine.

As the central repository and transmitter of new medical information, including scientific studies, clinical medicine reports, ethics measures, and education, medical journals (including those deemed prestigious) have historically been among the worst offenders in perpetuating non-DEI objectives in their leadership, staffing, focus, instructions for authors, style manuals, and published materials.

This issue came to a head in March 2021 when a JAMA podcast about racism in American medicine was followed by this promotional tweet: “No physician is racist, so how can there be structural racism in health care?”

Reactions and actions were rapid, strong, and decisive. After an interregnum at JAMA, a new editor in chief, Kirsten Bibbins-Domingo, PhD, MD, MAS, was named. She and her large staff of editors and editorial board members from the multijournal JAMA Network joined a worldwide movement of (currently) 56 publishing organizations representing 15,000 journals called the Joint Commitment for Action on Inclusion and Diversity in Publishing.

A recent JAMA editorial with 29 authors describes the entire commitment initiative of publishers-editors. It reports JAMA Network data from 2023 and 2024 from surveys of 455 editors (a 91% response rate) about their own gender (five choices), ethnic origins or geographic ancestry (13 choices), and race (eight choices), demonstrating considerable progress toward DEI goals. The survey’s complex multinational classifications may not jibe with the categorizations used in some countries (too bad that “mixed” is not “mixed in” — a missed opportunity).

This encouraging movement will not fix it all. But when people of certain groups are represented at the table, that point of view is far more likely to make it into the lexicon, language, and omnipresent work products, potentially changing cultural norms. Even the measurement of movement related to disparity in healthcare is marred by frequent variations of data accuracy. More consistency in what to measure can help a lot, and the medical literature can be very influential.

A personal anecdote: When I was a professor at UC Davis in 1978, Allan Bakke, MD, was my student. Some of you will remember the saga of affirmative action on admissions, which was just revisited in the light of a recent decision by the US Supreme Court.

Back in 1978, the dean at UC Davis told me that he kept two file folders on the admission processes in different desk drawers. One categorized all applicants and enrollees by race, and the other did not. Depending on who came to visit and ask questions, he would choose one or the other file to share once he figured out what they were looking for (this is not a joke).

The strength of the current active political pushback against the entire DEI movement has deep roots and should not be underestimated. There will be a lot of to-ing and fro-ing.

French writer Victor Hugo is credited with stating, “There is nothing as powerful as an idea whose time has come.” A majority of Americans, physicians, and other healthcare professionals believe in basic fairness. The time for DEI in all aspects of medicine is now.

Dr. Lundberg, editor in chief of Cancer Commons, disclosed having no relevant financial relationships.

A version of this article appeared on Medscape.com.