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Patient visits post COVID-19

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Has telemedicine found its footing?

When Alexander Graham Bell invented the telephone, he accomplished something that many telegraph devotees never thought possible: the synchronous, bidirectional transmission of voice over electrical lines.

verbaska_studio/Getty Images

This was an incredible milestone in the advancement of mankind and enabled true revolutions in commerce, scientific collaboration, and human interaction. But Mr. Bell knew his invention didn’t represent the final advancement in telecommunication; he was quite prescient in imagining a day when individuals could see each other while speaking on the phone.

Many years later, what was once only a dream is now commonplace, and children growing up today can’t imagine a world where apps such as FaceTime and Skype don’t exist. Until recently, however, the medical community has been slow to adopt the idea of video interactions. This has dramatically changed because of the pandemic and the need for social distancing. It appears that telemedicine has found its footing, but whether it will remain popular once patients feel safe going to see their doctors in person again remains to be seen. This month, we’ll examine a few key issues that will determine the future of virtual medical visits.
 

Collect calling

The pandemic has wrought both human and economic casualties. With fear, job loss, and regulations leading to decreased spending, many large and small businesses have been and will continue to be unable to survive. Companies, including Brooks Brothers, Hertz, Lord and Taylor, GNC, and J.C. Penney, have declared bankruptcy.1 Medical practices and hospitals have taken cuts to their bottom line, and we’ve heard of many physician groups that have had to enact substantial salary cuts or even lay off providers – something previously unheard of. Recent months have demonstrated the health care community’s commitment to put patients first, but we simply cannot survive if we aren’t adequately reimbursed. Traditionally, this has been a significant roadblock toward the widespread adoption of telemedicine.

Until the pandemic, virtual visits were paid for by a very small number of insurance carriers, often at a decreased rate and in limited circumstances. In most cases, these visits were not reimbursed at all. Thankfully, shortly after the coronavirus hit our shores, Medicare and Medicaid changed their policies, offering equal payment for video and in-person patient encounters. Most private insurers have followed suit, but the commitment to this payment parity appears – thus far – to be temporary. It is unclear that the financial support of telemedicine will continue post COVID-19, and this has many physicians feeling uncomfortable. In the meantime, many patients have come to prefer virtual visits, appreciating the convenience and efficiency.

Physicians don’t always have the same experience. Telemedicine can be technically challenging and take just as much – or sometimes more – time to navigate and document. Unless they are reimbursed equitably, providers will be forced to limit their use of virtual visits or not offer them at all. This leads to another issue: reliability.
 

‘Can you hear me now?’

Over the past several months, we have had the opportunity to use telemedicine firsthand and have spoken to many other physicians and patients about their experiences with it. The reports are all quite consistent: Most have had generally positive things to say. Still, some common concerns emerge when diving a bit deeper. Most notably are complaints about usability and reliability of the software.

While there are large telemedicine companies that have developed world-class cross-platform products, many in use today are proprietary and EHR dependent. As a result, the quality varies widely. Many EHR vendors were caught completely off guard by the sudden demand for telemedicine and are playing catch-up as they develop their own virtual visit platforms. While these vendor-developed platforms promise tight integration with patient records, some have significant shortcomings in stability when taxed under high utilization, including choppy video and garbled voice. This simply won’t do if telemedicine is to survive. It is incumbent on software developers and health care providers to invest in high-quality, reliable platforms on which to build their virtual visit offerings. This will ensure a more rapid adoption and the “staying power” of the new technology.
 

Dialing ‘0’ for the operator

Once seen as a “novelty” offered by only a small number of medical providers, virtual visits now represent a significant and ever-increasing percentage of patient encounters. The technology therefore must be easy to use. Given confidentiality and documentation requirements, along with the broad variety of available computing platforms and devices (e.g., PC, Mac, iOS, and Android), the process is often far from problem free. Patients may need help downloading apps, setting up webcams, or registering for the service. Providers may face issues with Internet connectivity or EHR-related delays.

Dr. Chris Notte and Dr. Neil Skolnik

It is critical that help be available to make the connection seamless and the experience a positive one. We are fortunate to work for a health care institution that has made this a priority, dedicating a team of individuals to provide real-time support to patients and clinicians. Small independent practices may not have this luxury, but we would encourage all providers to engage with their telemedicine or EHR vendors to determine what resources are available when problems arise, as they undoubtedly will.
 

Answering the call

Like the invention of the telephone, the advent of telemedicine is another milestone on the journey toward better communication with our patients, and it appears to be here to stay. Virtual visits won’t completely replace in-person care, nor minimize the benefit of human interaction, but they will continue to play an important role in the care continuum. By addressing the above concerns, we’ll lay a solid foundation for success and create a positive experience for physicians and patients alike.

Dr. Notte is a family physician and chief medical officer of Abington (Pa.) Hospital–Jefferson Health. Follow him on Twitter (@doctornotte). Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington (Pa.) Hospital–Jefferson Health. They have no conflicts related to the content of this piece.

Reference

1. A running list of companies that have filed for bankruptcy during the coronavirus pandemic. Fortune.

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Has telemedicine found its footing?

Has telemedicine found its footing?

When Alexander Graham Bell invented the telephone, he accomplished something that many telegraph devotees never thought possible: the synchronous, bidirectional transmission of voice over electrical lines.

verbaska_studio/Getty Images

This was an incredible milestone in the advancement of mankind and enabled true revolutions in commerce, scientific collaboration, and human interaction. But Mr. Bell knew his invention didn’t represent the final advancement in telecommunication; he was quite prescient in imagining a day when individuals could see each other while speaking on the phone.

Many years later, what was once only a dream is now commonplace, and children growing up today can’t imagine a world where apps such as FaceTime and Skype don’t exist. Until recently, however, the medical community has been slow to adopt the idea of video interactions. This has dramatically changed because of the pandemic and the need for social distancing. It appears that telemedicine has found its footing, but whether it will remain popular once patients feel safe going to see their doctors in person again remains to be seen. This month, we’ll examine a few key issues that will determine the future of virtual medical visits.
 

Collect calling

The pandemic has wrought both human and economic casualties. With fear, job loss, and regulations leading to decreased spending, many large and small businesses have been and will continue to be unable to survive. Companies, including Brooks Brothers, Hertz, Lord and Taylor, GNC, and J.C. Penney, have declared bankruptcy.1 Medical practices and hospitals have taken cuts to their bottom line, and we’ve heard of many physician groups that have had to enact substantial salary cuts or even lay off providers – something previously unheard of. Recent months have demonstrated the health care community’s commitment to put patients first, but we simply cannot survive if we aren’t adequately reimbursed. Traditionally, this has been a significant roadblock toward the widespread adoption of telemedicine.

Until the pandemic, virtual visits were paid for by a very small number of insurance carriers, often at a decreased rate and in limited circumstances. In most cases, these visits were not reimbursed at all. Thankfully, shortly after the coronavirus hit our shores, Medicare and Medicaid changed their policies, offering equal payment for video and in-person patient encounters. Most private insurers have followed suit, but the commitment to this payment parity appears – thus far – to be temporary. It is unclear that the financial support of telemedicine will continue post COVID-19, and this has many physicians feeling uncomfortable. In the meantime, many patients have come to prefer virtual visits, appreciating the convenience and efficiency.

Physicians don’t always have the same experience. Telemedicine can be technically challenging and take just as much – or sometimes more – time to navigate and document. Unless they are reimbursed equitably, providers will be forced to limit their use of virtual visits or not offer them at all. This leads to another issue: reliability.
 

‘Can you hear me now?’

Over the past several months, we have had the opportunity to use telemedicine firsthand and have spoken to many other physicians and patients about their experiences with it. The reports are all quite consistent: Most have had generally positive things to say. Still, some common concerns emerge when diving a bit deeper. Most notably are complaints about usability and reliability of the software.

While there are large telemedicine companies that have developed world-class cross-platform products, many in use today are proprietary and EHR dependent. As a result, the quality varies widely. Many EHR vendors were caught completely off guard by the sudden demand for telemedicine and are playing catch-up as they develop their own virtual visit platforms. While these vendor-developed platforms promise tight integration with patient records, some have significant shortcomings in stability when taxed under high utilization, including choppy video and garbled voice. This simply won’t do if telemedicine is to survive. It is incumbent on software developers and health care providers to invest in high-quality, reliable platforms on which to build their virtual visit offerings. This will ensure a more rapid adoption and the “staying power” of the new technology.
 

Dialing ‘0’ for the operator

Once seen as a “novelty” offered by only a small number of medical providers, virtual visits now represent a significant and ever-increasing percentage of patient encounters. The technology therefore must be easy to use. Given confidentiality and documentation requirements, along with the broad variety of available computing platforms and devices (e.g., PC, Mac, iOS, and Android), the process is often far from problem free. Patients may need help downloading apps, setting up webcams, or registering for the service. Providers may face issues with Internet connectivity or EHR-related delays.

Dr. Chris Notte and Dr. Neil Skolnik

It is critical that help be available to make the connection seamless and the experience a positive one. We are fortunate to work for a health care institution that has made this a priority, dedicating a team of individuals to provide real-time support to patients and clinicians. Small independent practices may not have this luxury, but we would encourage all providers to engage with their telemedicine or EHR vendors to determine what resources are available when problems arise, as they undoubtedly will.
 

Answering the call

Like the invention of the telephone, the advent of telemedicine is another milestone on the journey toward better communication with our patients, and it appears to be here to stay. Virtual visits won’t completely replace in-person care, nor minimize the benefit of human interaction, but they will continue to play an important role in the care continuum. By addressing the above concerns, we’ll lay a solid foundation for success and create a positive experience for physicians and patients alike.

Dr. Notte is a family physician and chief medical officer of Abington (Pa.) Hospital–Jefferson Health. Follow him on Twitter (@doctornotte). Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington (Pa.) Hospital–Jefferson Health. They have no conflicts related to the content of this piece.

Reference

1. A running list of companies that have filed for bankruptcy during the coronavirus pandemic. Fortune.

When Alexander Graham Bell invented the telephone, he accomplished something that many telegraph devotees never thought possible: the synchronous, bidirectional transmission of voice over electrical lines.

verbaska_studio/Getty Images

This was an incredible milestone in the advancement of mankind and enabled true revolutions in commerce, scientific collaboration, and human interaction. But Mr. Bell knew his invention didn’t represent the final advancement in telecommunication; he was quite prescient in imagining a day when individuals could see each other while speaking on the phone.

Many years later, what was once only a dream is now commonplace, and children growing up today can’t imagine a world where apps such as FaceTime and Skype don’t exist. Until recently, however, the medical community has been slow to adopt the idea of video interactions. This has dramatically changed because of the pandemic and the need for social distancing. It appears that telemedicine has found its footing, but whether it will remain popular once patients feel safe going to see their doctors in person again remains to be seen. This month, we’ll examine a few key issues that will determine the future of virtual medical visits.
 

Collect calling

The pandemic has wrought both human and economic casualties. With fear, job loss, and regulations leading to decreased spending, many large and small businesses have been and will continue to be unable to survive. Companies, including Brooks Brothers, Hertz, Lord and Taylor, GNC, and J.C. Penney, have declared bankruptcy.1 Medical practices and hospitals have taken cuts to their bottom line, and we’ve heard of many physician groups that have had to enact substantial salary cuts or even lay off providers – something previously unheard of. Recent months have demonstrated the health care community’s commitment to put patients first, but we simply cannot survive if we aren’t adequately reimbursed. Traditionally, this has been a significant roadblock toward the widespread adoption of telemedicine.

Until the pandemic, virtual visits were paid for by a very small number of insurance carriers, often at a decreased rate and in limited circumstances. In most cases, these visits were not reimbursed at all. Thankfully, shortly after the coronavirus hit our shores, Medicare and Medicaid changed their policies, offering equal payment for video and in-person patient encounters. Most private insurers have followed suit, but the commitment to this payment parity appears – thus far – to be temporary. It is unclear that the financial support of telemedicine will continue post COVID-19, and this has many physicians feeling uncomfortable. In the meantime, many patients have come to prefer virtual visits, appreciating the convenience and efficiency.

Physicians don’t always have the same experience. Telemedicine can be technically challenging and take just as much – or sometimes more – time to navigate and document. Unless they are reimbursed equitably, providers will be forced to limit their use of virtual visits or not offer them at all. This leads to another issue: reliability.
 

‘Can you hear me now?’

Over the past several months, we have had the opportunity to use telemedicine firsthand and have spoken to many other physicians and patients about their experiences with it. The reports are all quite consistent: Most have had generally positive things to say. Still, some common concerns emerge when diving a bit deeper. Most notably are complaints about usability and reliability of the software.

While there are large telemedicine companies that have developed world-class cross-platform products, many in use today are proprietary and EHR dependent. As a result, the quality varies widely. Many EHR vendors were caught completely off guard by the sudden demand for telemedicine and are playing catch-up as they develop their own virtual visit platforms. While these vendor-developed platforms promise tight integration with patient records, some have significant shortcomings in stability when taxed under high utilization, including choppy video and garbled voice. This simply won’t do if telemedicine is to survive. It is incumbent on software developers and health care providers to invest in high-quality, reliable platforms on which to build their virtual visit offerings. This will ensure a more rapid adoption and the “staying power” of the new technology.
 

Dialing ‘0’ for the operator

Once seen as a “novelty” offered by only a small number of medical providers, virtual visits now represent a significant and ever-increasing percentage of patient encounters. The technology therefore must be easy to use. Given confidentiality and documentation requirements, along with the broad variety of available computing platforms and devices (e.g., PC, Mac, iOS, and Android), the process is often far from problem free. Patients may need help downloading apps, setting up webcams, or registering for the service. Providers may face issues with Internet connectivity or EHR-related delays.

Dr. Chris Notte and Dr. Neil Skolnik

It is critical that help be available to make the connection seamless and the experience a positive one. We are fortunate to work for a health care institution that has made this a priority, dedicating a team of individuals to provide real-time support to patients and clinicians. Small independent practices may not have this luxury, but we would encourage all providers to engage with their telemedicine or EHR vendors to determine what resources are available when problems arise, as they undoubtedly will.
 

Answering the call

Like the invention of the telephone, the advent of telemedicine is another milestone on the journey toward better communication with our patients, and it appears to be here to stay. Virtual visits won’t completely replace in-person care, nor minimize the benefit of human interaction, but they will continue to play an important role in the care continuum. By addressing the above concerns, we’ll lay a solid foundation for success and create a positive experience for physicians and patients alike.

Dr. Notte is a family physician and chief medical officer of Abington (Pa.) Hospital–Jefferson Health. Follow him on Twitter (@doctornotte). Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington (Pa.) Hospital–Jefferson Health. They have no conflicts related to the content of this piece.

Reference

1. A running list of companies that have filed for bankruptcy during the coronavirus pandemic. Fortune.

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Swab, spit, stay home? College coronavirus testing plans are all over the map

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Thu, 08/26/2021 - 16:01

Yousuf El-Jayyousi, a junior engineering student at the University of Missouri, wanted guidance and reassurance that it would be safe to go back to school for the fall semester. He tuned into a pair of online town halls organized by the university hoping to find that.

He did not.

Christine Herman/Illinois Public Media
University of Illinois graduate student Kristen Muñoz submits her saliva sample for COVID-19 testing on the Urbana-Champaign campus. 

What he got instead from those town halls last month was encouragement to return to class at the institution affectionately known as Mizzou. The university, in Columbia, would be testing only people with symptoms, and at that point, the university said people who test positive off campus were under no obligation to inform the school.

“It feels like the university doesn’t really care whether we get sick or not,” said El-Jayyousi, who is scheduled for two in-person classes, and lives at home with his parents and 90-year-old grandmother.

He’s seen the studies from researchers at Yale and Harvard that suggest testing needs to be much more widespread. He asked his instructors if he could join lectures remotely once classes begin Monday. One was considering it; the other rejected it.

“It was kind of very dismissive, like ‘so what?’ ” El-Jayyousi said.

But it’s an enormous “so what?” packed with fear and unknowns for Jayyousi and some 20 million other students enrolled in some level of postsecondary education in America, if they are not already online only.

As with the uncoordinated and chaotic national response to the COVID-19 pandemic, higher education has no clear guidance or set of standards to adhere to from the federal government or anywhere else. Policies for reentry onto campuses that were abruptly shut in March are all over the map.

Hundreds Undecided

According to the College Crisis Initiative, or C2i, a project of Davidson College that monitors how higher ed is responding to the pandemic, there is nothing resembling a common approach. Of 2,958 institutions it follows, 151 were planning to open fully online, 729 were mostly online and 433 were taking a hybrid approach. Just 75 schools were insisting on students attending fully in person, and 614 were aiming to be primarily in-person. Some 800 others were still deciding, just weeks before instruction was to start.

The decisions often have little correlation with the public health advisories in the region. Mizzou, which is in an area with recent COVID spikes, is holding some in-person instruction and has nearly 7,000 students signed up to live in dorms and other university-owned housing. Harvard, in a region with extremely low rates of viral spread, has opted to go all online and allowed students to defer a year.

The specific circumstances colleges and universities face are as much determined by local fiscal and political dictates as by medicine and epidemiology. It is often unclear who is making the call. So it’s every student for herself to chart these unknown waters, even as students (or their families) have written tuition checks for tens of thousands of dollars and signed leases for campus and off-campus housing.

And the risks – health, educational and financial – boomerang back on individual students: Two weeks after University of North Carolina students, as instructed, returned to the flagship campus in Chapel Hill with the promise of at least some in-person learning, all classes went online. Early outbreaks surged from a few students to more than 130 in a matter of days. Most undergrads have about a week to clear out of their dorms.

“It’s really tough,” said neuroscience major Luke Lawless, 20. “Chapel Hill is an amazing place, and as a senior it’s tough to know that my time’s running out – and the virus only adds to that.”
 

 

 

Location, location, location

C2i’s creator, Davidson education Assistant Professor Chris Marsicano, said the extreme diversity of approaches comes from the sheer diversity of schools, the penchant of many to follow the leads of more prestigious peers, and local politics.

“Some states have very strong and stringent mask requirements. Some have stronger stay-at-home orders. Others are sort of leaving it up to localities. So the confluence of politics, institutional isomorphism – that imitation – and different needs that the institutions have are driving the differences,” Marsicano said.

Location matters a lot, too, Marsicano said, pointing to schools like George Washington University and Boston University in urban settings where the environment is beyond the control of the school, versus a place like the University of the South in remote, rural Sewanee, Tennessee, where 90% of students will return to campus.

“It’s a lot easier to control an outbreak if you are a fairly isolated college campus than if you are in the middle of a city,” Marsicano said.

Student behavior is another wild card, Marsicano said, since even the best plans will fail if college kids “do something stupid, like have a massive frat party without masks.”

“You’ve got student affairs professionals across the country who are screaming at the top of their lungs, ‘We can’t control student behavior when they go off campus’” Marsicano said.

Another factor is a vacuum at the federal level. Although the Department of Education says Secretary Betsy DeVos has held dozens of calls with governors and state education superintendents, there’s no sign of an attempt to offer unified guidance to colleges beyond a webpage that links to relaxed regulatory requirements and anodyne fact sheets from the Centers for Disease Control and Prevention on preventing viral spread.

Even the money that the department notes it has dispensed – $30 billion from Congress’ CARES Act – is weighted toward K-12 schools, with about $13 billion for higher education, including student aid.

The U.S. Senate adjourned last week until Sept. 8, having never taken up a House-passed relief package that included some $30 billion for higher education. A trio of Democratic senators, including Sen. Elizabeth Warren, is calling for national reporting standards on college campuses.
 

No benchmarks

Campus communities with very different levels of contagion are making opposite calls about in-person learning. Mizzou’s Boone County has seen more than 1,400 confirmed COVID cases after a spike in mid-July. According to the Harvard Global Health Institute’s COVID risk map, Boone has accelerated spread, with 14 infections per day per 100,000 people. The institute advises stay-at-home orders or rigorous testing and tracing at such rates of infection. Two neighboring counties were in the red zone recently, with more than 25 cases per day per 100,000 people. Mizzou has left it up to deans whether classes will meet in person, making a strong argument for face-to-face instruction.

Meanwhile, Columbia University in New York City opted for all online instruction, even though the rate of infection there is a comparatively low 3.8 cases per day per 100,000 people.

Administrators at Mizzou considered and rejected mandatory testing. “All that does is provide one a snapshot of the situation,” University of Missouri system President Mun Choi said in one of the town halls.

Mizzou has an in-house team that will carry out case investigation and contact tracing with the local health department. This week, following questions from the press and pressure from the public, the university announced students will be required to report any positive COVID test to the school.
 

 

Who do you test? When?

CDC guidance for higher education suggests there’s not enough data to know whether testing everyone is effective, but some influential researchers, such as those at Harvard and Yale, disagree.

“This virus is subject to silent spreading and asymptomatic spreading, and it’s very hard to play catch-up,” said Yale professor David Paltiel, who studies public health policy. “And so thinking that you can keep your campus safe by simply waiting until students develop symptoms before acting, I think, is a very dangerous game.”

Simulation models conducted by Paltiel and his colleagues show that, of all the factors university administrators can control – including the sensitivity and specificity of COVID-19 tests – the frequency of testing is most important.

He’s “painfully aware” that testing everyone on campus every few days sets a very high bar – logistically, financially, behaviorally – that may be beyond what most schools can reach. But he says the consequences of reopening campuses without those measures are severe, not just for students, but for vulnerable populations among school workers and in the surrounding community.

“You really have to ask yourself whether you have any business reopening if you’re not going to commit to an aggressive program of high-frequency testing,” he said.
 

The fighting – and testing – Illini

Some institutions that desperately want students to return to campus are backing the goal with a maximal approach to safety and testing.

About a 4-hour drive east along the interstates from Mizzou is the University of Illinois at Urbana-Champaign, whose sports teams are known as the Fighting Illini.

Weeks ago, large white tents with signs reading “Walk-Up COVID-19 Testing” have popped up across campus; there students take a simple saliva test.

“This seems to be a lot easier than sticking a cotton swab up your nose,” graduate student Kristen Muñoz said after collecting a bit of her saliva in a plastic tube and sealing it in a bag labeled “Biohazard.”

In just a few hours, she got back her result: negative.

The school plans to offer free tests to the 50,000 students expected to return this month, as well as some 11,000 faculty and staff members.

“The exciting thing is, because we can test up to 10,000 per day, it allows the scientist to do what’s really the best for trying to protect the community as opposed to having to cut corners, because of the limitations of the testing,” said University of Illinois chemist Martin Burke, who helped develop the campus’s saliva test, which received emergency use authorization from the federal Food and Drug Administration this week.

The test is similar to one designed by Yale and funded by the NBA that cleared the FDA hurdle just before the Illinois test. Both Yale and Illinois hope aggressive testing will allow most undergraduate students to live on campus, even though most classes will be online.

University of Illinois epidemiologist Becky Smith said they are following data that suggest campuses need to test everyone every few days because the virus is not detectable in infected people for 3 or 4 days.

“But about two days after that, your infectiousness peaks,” she said. “So, we have a very small window of time in which to catch people before they have done most of the infection that they’re going to be doing.”

Campus officials accepted Smith’s recommendation that all faculty, staffers and students participating in any on-campus activities be required to get tested twice a week.

Illinois can do that because its test is convenient and not invasive, which spares the campus from using as much personal protective equipment as the more invasive tests require, Burke said. And on-site analysis avoids backlogs at public health and commercial labs.
 

 

 

Muddled in the middle

Most other colleges fall somewhere between the approaches of Mizzou and the University of Illinois, and many of their students still are uncertain how their fall semester will go.

At the University of Southern California, a private campus of about 48,500 students in Los Angeles, officials had hoped to have about 20% of classes in person – but the county government scaled that back, insisting on tougher rules for reopening than the statewide standards.

If students eventually are allowed back, they will have to show a recent coronavirus test result that they obtained on their own, said Dr. Sarah Van Orman, chief health officer of USC Student Health.

They will be asked to do daily health assessments, such as fever checks, and those who have been exposed to the virus or show symptoms will receive a rapid test, with about a 24-hour turnaround through the university medical center’s lab. “We believe it is really important to have very rapid access to those results,” Van Orman said.

At California State University – the nation’s largest 4-year system, with 23 campuses and nearly a half-million students – officials decided back in May to move nearly all its fall courses online.

“The first priority was really the health and safety of all of the campus community,” said Mike Uhlenkamp, spokesperson for the CSU Chancellor’s Office. About 10% of CSU students are expected to attend some in-person classes, such as nursing lab courses, fine art and dance classes, and some graduate classes.

Uhlenkamp said testing protocols are being left up to each campus, though all are required to follow local safety guidelines. And without a medical campus in the system, CSU campuses do not have the same capacity to take charge of their own testing, as the University of Illinois is doing.

For students who know they won’t be on campus this fall, there is regret at lost social experiences, networking and hands-on learning so important to college.

But the certainty also brings relief.

“I don’t think I would want to be indoors with a group of, you know, even just a handful of people, even if we have masks on,” said Haley Gray, a 28-year-old graduate student at the University of California-Berkeley starting the second year of her journalism program.

She knows she won’t have access to Berkeley’s advanced media labs or the collaborative sessions students experience there. And she said she realized the other day she probably won’t just sit around the student lounge and strike up unexpected friendships.

“That’s a pretty big bummer but, you know, I think overall we’re all just doing our best, and given the circumstances, I feel pretty OK about it,” she said.

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente. This story is part of a partnership that includes KBIA, Illinois Public Media, Side Effects Public Media, NPR and Kaiser Health News. 

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Yousuf El-Jayyousi, a junior engineering student at the University of Missouri, wanted guidance and reassurance that it would be safe to go back to school for the fall semester. He tuned into a pair of online town halls organized by the university hoping to find that.

He did not.

Christine Herman/Illinois Public Media
University of Illinois graduate student Kristen Muñoz submits her saliva sample for COVID-19 testing on the Urbana-Champaign campus. 

What he got instead from those town halls last month was encouragement to return to class at the institution affectionately known as Mizzou. The university, in Columbia, would be testing only people with symptoms, and at that point, the university said people who test positive off campus were under no obligation to inform the school.

“It feels like the university doesn’t really care whether we get sick or not,” said El-Jayyousi, who is scheduled for two in-person classes, and lives at home with his parents and 90-year-old grandmother.

He’s seen the studies from researchers at Yale and Harvard that suggest testing needs to be much more widespread. He asked his instructors if he could join lectures remotely once classes begin Monday. One was considering it; the other rejected it.

“It was kind of very dismissive, like ‘so what?’ ” El-Jayyousi said.

But it’s an enormous “so what?” packed with fear and unknowns for Jayyousi and some 20 million other students enrolled in some level of postsecondary education in America, if they are not already online only.

As with the uncoordinated and chaotic national response to the COVID-19 pandemic, higher education has no clear guidance or set of standards to adhere to from the federal government or anywhere else. Policies for reentry onto campuses that were abruptly shut in March are all over the map.

Hundreds Undecided

According to the College Crisis Initiative, or C2i, a project of Davidson College that monitors how higher ed is responding to the pandemic, there is nothing resembling a common approach. Of 2,958 institutions it follows, 151 were planning to open fully online, 729 were mostly online and 433 were taking a hybrid approach. Just 75 schools were insisting on students attending fully in person, and 614 were aiming to be primarily in-person. Some 800 others were still deciding, just weeks before instruction was to start.

The decisions often have little correlation with the public health advisories in the region. Mizzou, which is in an area with recent COVID spikes, is holding some in-person instruction and has nearly 7,000 students signed up to live in dorms and other university-owned housing. Harvard, in a region with extremely low rates of viral spread, has opted to go all online and allowed students to defer a year.

The specific circumstances colleges and universities face are as much determined by local fiscal and political dictates as by medicine and epidemiology. It is often unclear who is making the call. So it’s every student for herself to chart these unknown waters, even as students (or their families) have written tuition checks for tens of thousands of dollars and signed leases for campus and off-campus housing.

And the risks – health, educational and financial – boomerang back on individual students: Two weeks after University of North Carolina students, as instructed, returned to the flagship campus in Chapel Hill with the promise of at least some in-person learning, all classes went online. Early outbreaks surged from a few students to more than 130 in a matter of days. Most undergrads have about a week to clear out of their dorms.

“It’s really tough,” said neuroscience major Luke Lawless, 20. “Chapel Hill is an amazing place, and as a senior it’s tough to know that my time’s running out – and the virus only adds to that.”
 

 

 

Location, location, location

C2i’s creator, Davidson education Assistant Professor Chris Marsicano, said the extreme diversity of approaches comes from the sheer diversity of schools, the penchant of many to follow the leads of more prestigious peers, and local politics.

“Some states have very strong and stringent mask requirements. Some have stronger stay-at-home orders. Others are sort of leaving it up to localities. So the confluence of politics, institutional isomorphism – that imitation – and different needs that the institutions have are driving the differences,” Marsicano said.

Location matters a lot, too, Marsicano said, pointing to schools like George Washington University and Boston University in urban settings where the environment is beyond the control of the school, versus a place like the University of the South in remote, rural Sewanee, Tennessee, where 90% of students will return to campus.

“It’s a lot easier to control an outbreak if you are a fairly isolated college campus than if you are in the middle of a city,” Marsicano said.

Student behavior is another wild card, Marsicano said, since even the best plans will fail if college kids “do something stupid, like have a massive frat party without masks.”

“You’ve got student affairs professionals across the country who are screaming at the top of their lungs, ‘We can’t control student behavior when they go off campus’” Marsicano said.

Another factor is a vacuum at the federal level. Although the Department of Education says Secretary Betsy DeVos has held dozens of calls with governors and state education superintendents, there’s no sign of an attempt to offer unified guidance to colleges beyond a webpage that links to relaxed regulatory requirements and anodyne fact sheets from the Centers for Disease Control and Prevention on preventing viral spread.

Even the money that the department notes it has dispensed – $30 billion from Congress’ CARES Act – is weighted toward K-12 schools, with about $13 billion for higher education, including student aid.

The U.S. Senate adjourned last week until Sept. 8, having never taken up a House-passed relief package that included some $30 billion for higher education. A trio of Democratic senators, including Sen. Elizabeth Warren, is calling for national reporting standards on college campuses.
 

No benchmarks

Campus communities with very different levels of contagion are making opposite calls about in-person learning. Mizzou’s Boone County has seen more than 1,400 confirmed COVID cases after a spike in mid-July. According to the Harvard Global Health Institute’s COVID risk map, Boone has accelerated spread, with 14 infections per day per 100,000 people. The institute advises stay-at-home orders or rigorous testing and tracing at such rates of infection. Two neighboring counties were in the red zone recently, with more than 25 cases per day per 100,000 people. Mizzou has left it up to deans whether classes will meet in person, making a strong argument for face-to-face instruction.

Meanwhile, Columbia University in New York City opted for all online instruction, even though the rate of infection there is a comparatively low 3.8 cases per day per 100,000 people.

Administrators at Mizzou considered and rejected mandatory testing. “All that does is provide one a snapshot of the situation,” University of Missouri system President Mun Choi said in one of the town halls.

Mizzou has an in-house team that will carry out case investigation and contact tracing with the local health department. This week, following questions from the press and pressure from the public, the university announced students will be required to report any positive COVID test to the school.
 

 

Who do you test? When?

CDC guidance for higher education suggests there’s not enough data to know whether testing everyone is effective, but some influential researchers, such as those at Harvard and Yale, disagree.

“This virus is subject to silent spreading and asymptomatic spreading, and it’s very hard to play catch-up,” said Yale professor David Paltiel, who studies public health policy. “And so thinking that you can keep your campus safe by simply waiting until students develop symptoms before acting, I think, is a very dangerous game.”

Simulation models conducted by Paltiel and his colleagues show that, of all the factors university administrators can control – including the sensitivity and specificity of COVID-19 tests – the frequency of testing is most important.

He’s “painfully aware” that testing everyone on campus every few days sets a very high bar – logistically, financially, behaviorally – that may be beyond what most schools can reach. But he says the consequences of reopening campuses without those measures are severe, not just for students, but for vulnerable populations among school workers and in the surrounding community.

“You really have to ask yourself whether you have any business reopening if you’re not going to commit to an aggressive program of high-frequency testing,” he said.
 

The fighting – and testing – Illini

Some institutions that desperately want students to return to campus are backing the goal with a maximal approach to safety and testing.

About a 4-hour drive east along the interstates from Mizzou is the University of Illinois at Urbana-Champaign, whose sports teams are known as the Fighting Illini.

Weeks ago, large white tents with signs reading “Walk-Up COVID-19 Testing” have popped up across campus; there students take a simple saliva test.

“This seems to be a lot easier than sticking a cotton swab up your nose,” graduate student Kristen Muñoz said after collecting a bit of her saliva in a plastic tube and sealing it in a bag labeled “Biohazard.”

In just a few hours, she got back her result: negative.

The school plans to offer free tests to the 50,000 students expected to return this month, as well as some 11,000 faculty and staff members.

“The exciting thing is, because we can test up to 10,000 per day, it allows the scientist to do what’s really the best for trying to protect the community as opposed to having to cut corners, because of the limitations of the testing,” said University of Illinois chemist Martin Burke, who helped develop the campus’s saliva test, which received emergency use authorization from the federal Food and Drug Administration this week.

The test is similar to one designed by Yale and funded by the NBA that cleared the FDA hurdle just before the Illinois test. Both Yale and Illinois hope aggressive testing will allow most undergraduate students to live on campus, even though most classes will be online.

University of Illinois epidemiologist Becky Smith said they are following data that suggest campuses need to test everyone every few days because the virus is not detectable in infected people for 3 or 4 days.

“But about two days after that, your infectiousness peaks,” she said. “So, we have a very small window of time in which to catch people before they have done most of the infection that they’re going to be doing.”

Campus officials accepted Smith’s recommendation that all faculty, staffers and students participating in any on-campus activities be required to get tested twice a week.

Illinois can do that because its test is convenient and not invasive, which spares the campus from using as much personal protective equipment as the more invasive tests require, Burke said. And on-site analysis avoids backlogs at public health and commercial labs.
 

 

 

Muddled in the middle

Most other colleges fall somewhere between the approaches of Mizzou and the University of Illinois, and many of their students still are uncertain how their fall semester will go.

At the University of Southern California, a private campus of about 48,500 students in Los Angeles, officials had hoped to have about 20% of classes in person – but the county government scaled that back, insisting on tougher rules for reopening than the statewide standards.

If students eventually are allowed back, they will have to show a recent coronavirus test result that they obtained on their own, said Dr. Sarah Van Orman, chief health officer of USC Student Health.

They will be asked to do daily health assessments, such as fever checks, and those who have been exposed to the virus or show symptoms will receive a rapid test, with about a 24-hour turnaround through the university medical center’s lab. “We believe it is really important to have very rapid access to those results,” Van Orman said.

At California State University – the nation’s largest 4-year system, with 23 campuses and nearly a half-million students – officials decided back in May to move nearly all its fall courses online.

“The first priority was really the health and safety of all of the campus community,” said Mike Uhlenkamp, spokesperson for the CSU Chancellor’s Office. About 10% of CSU students are expected to attend some in-person classes, such as nursing lab courses, fine art and dance classes, and some graduate classes.

Uhlenkamp said testing protocols are being left up to each campus, though all are required to follow local safety guidelines. And without a medical campus in the system, CSU campuses do not have the same capacity to take charge of their own testing, as the University of Illinois is doing.

For students who know they won’t be on campus this fall, there is regret at lost social experiences, networking and hands-on learning so important to college.

But the certainty also brings relief.

“I don’t think I would want to be indoors with a group of, you know, even just a handful of people, even if we have masks on,” said Haley Gray, a 28-year-old graduate student at the University of California-Berkeley starting the second year of her journalism program.

She knows she won’t have access to Berkeley’s advanced media labs or the collaborative sessions students experience there. And she said she realized the other day she probably won’t just sit around the student lounge and strike up unexpected friendships.

“That’s a pretty big bummer but, you know, I think overall we’re all just doing our best, and given the circumstances, I feel pretty OK about it,” she said.

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente. This story is part of a partnership that includes KBIA, Illinois Public Media, Side Effects Public Media, NPR and Kaiser Health News. 

Yousuf El-Jayyousi, a junior engineering student at the University of Missouri, wanted guidance and reassurance that it would be safe to go back to school for the fall semester. He tuned into a pair of online town halls organized by the university hoping to find that.

He did not.

Christine Herman/Illinois Public Media
University of Illinois graduate student Kristen Muñoz submits her saliva sample for COVID-19 testing on the Urbana-Champaign campus. 

What he got instead from those town halls last month was encouragement to return to class at the institution affectionately known as Mizzou. The university, in Columbia, would be testing only people with symptoms, and at that point, the university said people who test positive off campus were under no obligation to inform the school.

“It feels like the university doesn’t really care whether we get sick or not,” said El-Jayyousi, who is scheduled for two in-person classes, and lives at home with his parents and 90-year-old grandmother.

He’s seen the studies from researchers at Yale and Harvard that suggest testing needs to be much more widespread. He asked his instructors if he could join lectures remotely once classes begin Monday. One was considering it; the other rejected it.

“It was kind of very dismissive, like ‘so what?’ ” El-Jayyousi said.

But it’s an enormous “so what?” packed with fear and unknowns for Jayyousi and some 20 million other students enrolled in some level of postsecondary education in America, if they are not already online only.

As with the uncoordinated and chaotic national response to the COVID-19 pandemic, higher education has no clear guidance or set of standards to adhere to from the federal government or anywhere else. Policies for reentry onto campuses that were abruptly shut in March are all over the map.

Hundreds Undecided

According to the College Crisis Initiative, or C2i, a project of Davidson College that monitors how higher ed is responding to the pandemic, there is nothing resembling a common approach. Of 2,958 institutions it follows, 151 were planning to open fully online, 729 were mostly online and 433 were taking a hybrid approach. Just 75 schools were insisting on students attending fully in person, and 614 were aiming to be primarily in-person. Some 800 others were still deciding, just weeks before instruction was to start.

The decisions often have little correlation with the public health advisories in the region. Mizzou, which is in an area with recent COVID spikes, is holding some in-person instruction and has nearly 7,000 students signed up to live in dorms and other university-owned housing. Harvard, in a region with extremely low rates of viral spread, has opted to go all online and allowed students to defer a year.

The specific circumstances colleges and universities face are as much determined by local fiscal and political dictates as by medicine and epidemiology. It is often unclear who is making the call. So it’s every student for herself to chart these unknown waters, even as students (or their families) have written tuition checks for tens of thousands of dollars and signed leases for campus and off-campus housing.

And the risks – health, educational and financial – boomerang back on individual students: Two weeks after University of North Carolina students, as instructed, returned to the flagship campus in Chapel Hill with the promise of at least some in-person learning, all classes went online. Early outbreaks surged from a few students to more than 130 in a matter of days. Most undergrads have about a week to clear out of their dorms.

“It’s really tough,” said neuroscience major Luke Lawless, 20. “Chapel Hill is an amazing place, and as a senior it’s tough to know that my time’s running out – and the virus only adds to that.”
 

 

 

Location, location, location

C2i’s creator, Davidson education Assistant Professor Chris Marsicano, said the extreme diversity of approaches comes from the sheer diversity of schools, the penchant of many to follow the leads of more prestigious peers, and local politics.

“Some states have very strong and stringent mask requirements. Some have stronger stay-at-home orders. Others are sort of leaving it up to localities. So the confluence of politics, institutional isomorphism – that imitation – and different needs that the institutions have are driving the differences,” Marsicano said.

Location matters a lot, too, Marsicano said, pointing to schools like George Washington University and Boston University in urban settings where the environment is beyond the control of the school, versus a place like the University of the South in remote, rural Sewanee, Tennessee, where 90% of students will return to campus.

“It’s a lot easier to control an outbreak if you are a fairly isolated college campus than if you are in the middle of a city,” Marsicano said.

Student behavior is another wild card, Marsicano said, since even the best plans will fail if college kids “do something stupid, like have a massive frat party without masks.”

“You’ve got student affairs professionals across the country who are screaming at the top of their lungs, ‘We can’t control student behavior when they go off campus’” Marsicano said.

Another factor is a vacuum at the federal level. Although the Department of Education says Secretary Betsy DeVos has held dozens of calls with governors and state education superintendents, there’s no sign of an attempt to offer unified guidance to colleges beyond a webpage that links to relaxed regulatory requirements and anodyne fact sheets from the Centers for Disease Control and Prevention on preventing viral spread.

Even the money that the department notes it has dispensed – $30 billion from Congress’ CARES Act – is weighted toward K-12 schools, with about $13 billion for higher education, including student aid.

The U.S. Senate adjourned last week until Sept. 8, having never taken up a House-passed relief package that included some $30 billion for higher education. A trio of Democratic senators, including Sen. Elizabeth Warren, is calling for national reporting standards on college campuses.
 

No benchmarks

Campus communities with very different levels of contagion are making opposite calls about in-person learning. Mizzou’s Boone County has seen more than 1,400 confirmed COVID cases after a spike in mid-July. According to the Harvard Global Health Institute’s COVID risk map, Boone has accelerated spread, with 14 infections per day per 100,000 people. The institute advises stay-at-home orders or rigorous testing and tracing at such rates of infection. Two neighboring counties were in the red zone recently, with more than 25 cases per day per 100,000 people. Mizzou has left it up to deans whether classes will meet in person, making a strong argument for face-to-face instruction.

Meanwhile, Columbia University in New York City opted for all online instruction, even though the rate of infection there is a comparatively low 3.8 cases per day per 100,000 people.

Administrators at Mizzou considered and rejected mandatory testing. “All that does is provide one a snapshot of the situation,” University of Missouri system President Mun Choi said in one of the town halls.

Mizzou has an in-house team that will carry out case investigation and contact tracing with the local health department. This week, following questions from the press and pressure from the public, the university announced students will be required to report any positive COVID test to the school.
 

 

Who do you test? When?

CDC guidance for higher education suggests there’s not enough data to know whether testing everyone is effective, but some influential researchers, such as those at Harvard and Yale, disagree.

“This virus is subject to silent spreading and asymptomatic spreading, and it’s very hard to play catch-up,” said Yale professor David Paltiel, who studies public health policy. “And so thinking that you can keep your campus safe by simply waiting until students develop symptoms before acting, I think, is a very dangerous game.”

Simulation models conducted by Paltiel and his colleagues show that, of all the factors university administrators can control – including the sensitivity and specificity of COVID-19 tests – the frequency of testing is most important.

He’s “painfully aware” that testing everyone on campus every few days sets a very high bar – logistically, financially, behaviorally – that may be beyond what most schools can reach. But he says the consequences of reopening campuses without those measures are severe, not just for students, but for vulnerable populations among school workers and in the surrounding community.

“You really have to ask yourself whether you have any business reopening if you’re not going to commit to an aggressive program of high-frequency testing,” he said.
 

The fighting – and testing – Illini

Some institutions that desperately want students to return to campus are backing the goal with a maximal approach to safety and testing.

About a 4-hour drive east along the interstates from Mizzou is the University of Illinois at Urbana-Champaign, whose sports teams are known as the Fighting Illini.

Weeks ago, large white tents with signs reading “Walk-Up COVID-19 Testing” have popped up across campus; there students take a simple saliva test.

“This seems to be a lot easier than sticking a cotton swab up your nose,” graduate student Kristen Muñoz said after collecting a bit of her saliva in a plastic tube and sealing it in a bag labeled “Biohazard.”

In just a few hours, she got back her result: negative.

The school plans to offer free tests to the 50,000 students expected to return this month, as well as some 11,000 faculty and staff members.

“The exciting thing is, because we can test up to 10,000 per day, it allows the scientist to do what’s really the best for trying to protect the community as opposed to having to cut corners, because of the limitations of the testing,” said University of Illinois chemist Martin Burke, who helped develop the campus’s saliva test, which received emergency use authorization from the federal Food and Drug Administration this week.

The test is similar to one designed by Yale and funded by the NBA that cleared the FDA hurdle just before the Illinois test. Both Yale and Illinois hope aggressive testing will allow most undergraduate students to live on campus, even though most classes will be online.

University of Illinois epidemiologist Becky Smith said they are following data that suggest campuses need to test everyone every few days because the virus is not detectable in infected people for 3 or 4 days.

“But about two days after that, your infectiousness peaks,” she said. “So, we have a very small window of time in which to catch people before they have done most of the infection that they’re going to be doing.”

Campus officials accepted Smith’s recommendation that all faculty, staffers and students participating in any on-campus activities be required to get tested twice a week.

Illinois can do that because its test is convenient and not invasive, which spares the campus from using as much personal protective equipment as the more invasive tests require, Burke said. And on-site analysis avoids backlogs at public health and commercial labs.
 

 

 

Muddled in the middle

Most other colleges fall somewhere between the approaches of Mizzou and the University of Illinois, and many of their students still are uncertain how their fall semester will go.

At the University of Southern California, a private campus of about 48,500 students in Los Angeles, officials had hoped to have about 20% of classes in person – but the county government scaled that back, insisting on tougher rules for reopening than the statewide standards.

If students eventually are allowed back, they will have to show a recent coronavirus test result that they obtained on their own, said Dr. Sarah Van Orman, chief health officer of USC Student Health.

They will be asked to do daily health assessments, such as fever checks, and those who have been exposed to the virus or show symptoms will receive a rapid test, with about a 24-hour turnaround through the university medical center’s lab. “We believe it is really important to have very rapid access to those results,” Van Orman said.

At California State University – the nation’s largest 4-year system, with 23 campuses and nearly a half-million students – officials decided back in May to move nearly all its fall courses online.

“The first priority was really the health and safety of all of the campus community,” said Mike Uhlenkamp, spokesperson for the CSU Chancellor’s Office. About 10% of CSU students are expected to attend some in-person classes, such as nursing lab courses, fine art and dance classes, and some graduate classes.

Uhlenkamp said testing protocols are being left up to each campus, though all are required to follow local safety guidelines. And without a medical campus in the system, CSU campuses do not have the same capacity to take charge of their own testing, as the University of Illinois is doing.

For students who know they won’t be on campus this fall, there is regret at lost social experiences, networking and hands-on learning so important to college.

But the certainty also brings relief.

“I don’t think I would want to be indoors with a group of, you know, even just a handful of people, even if we have masks on,” said Haley Gray, a 28-year-old graduate student at the University of California-Berkeley starting the second year of her journalism program.

She knows she won’t have access to Berkeley’s advanced media labs or the collaborative sessions students experience there. And she said she realized the other day she probably won’t just sit around the student lounge and strike up unexpected friendships.

“That’s a pretty big bummer but, you know, I think overall we’re all just doing our best, and given the circumstances, I feel pretty OK about it,” she said.

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente. This story is part of a partnership that includes KBIA, Illinois Public Media, Side Effects Public Media, NPR and Kaiser Health News. 

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Biologic responses to metal implants: Dermatologic implications

Article Type
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Fri, 08/21/2020 - 10:34

Hypersensitivity to implantable devices, albeit rare, is a growing problem. Cutaneous and noncutaneous reactions can occur secondary to metals and metal alloys, according to a report on biological responses to metal implants released by the Food and Drug Administration in September 2019. Large controlled studies are lacking, and the FDA has initiated extensive postmarketing reviews of certain metal implants in response to safety concerns. Further research is needed on the composition of these implants, the diverse spectrum of metals used, the physical environment in which they are implanted, and the immune response associated with implants.

Dr. Lily Talakoub

Local and systemic type IV hypersensitivity reactions can result from exposure to metal ions, which are thought to act as haptens and bind to proteins. The hapten-protein complex acts as the antigen for the T cell. Additionally, both acute and chronic inflammatory responses secondary to wound healing and foreign body reactions can occur. Neutrophils and macrophages elicit a tissue response, which can cause aseptic infection, loosening of joints, and tissue damage. Furthermore, corrosion of metal implants can lead to release of metal ions, which can have genotoxic and carcinogenic effects.

Clinical and subclinical effects of implantable devices depend on the device itself, the composition of the device, the tissue type, and an individual’s immune characteristics. Metal debris released from implants can activate innate and adaptive immune responses through a variety of different mechanisms, depending on the implant type and in what tissues the implant is placed. In the case of orthopedic implants, the most common implants, osteoclasts can sense metal and induce proinflammatory cytokines, which can result in corrosion and uptake of metal particles. Metal devices used in the central nervous system, such as intracerebral electrodes, can cause inflammatory responses leading to tissue encapsulation of electrodes. Corrosion of electrodes and release of metal ions can also impede ion channels in the CNS, blocking critical neuron-signaling pathways. Inflammatory reactions surrounding cardiac and vascular implants containing metal activate coagulation cascades, resulting in endothelial injury and activation of thrombi.

Despite the commonly used term “metal allergy” that delineates a type IV hypersensitivity reaction, reports in the literature supports the existence of both innate and adaptive immune responses to metal implanted in tissues. The recommended terminology is “adverse reactions to metal debris.” The clinical presentation may not be straightforward or easily attributed to the implant. Diagnostic tools are limited and may not detect a causal relationship.

Dr. Naissan O. Wesley

Clinical symptoms can range from local rashes and pruritus to cardiac damage, depression, vertigo, and neurologic symptoms; autoimmune/autoinflammatory reactions including chronic fatigue and autoimmune-like systemic symptoms, such as joint pain, headaches, and hair loss, have also been reported in association with implants containing metal. In addition to pruritus, dermatologic manifestations can include erythema, edema, papules, vesicles, as well as systemic hypersensitivity reactions. Typically, cutaneous reactions usually present within 2 days to 24 months of implantation and may be considered surgical-site infections. Although these reactions can be treated with topical or oral corticosteroids, removal of the device is frequently needed for complete clearance.

In clinical practice, it has been frustrating that potential adverse reactions to metal implants are often overlooked because they are thought to be so rare. There are case series documenting metal implant hypersensitivity, but the actual prevalence of hypersensitivity or autoinflammatory reactions is not known. Testing methods are often inaccurate; therefore, identification of at-risk individuals and management of symptomatic patients with implants is important.

The 2016 American Contact Dermatitis Society guidelines do not recommend preimplantation patch testing unless there is a suspected metal allergy. However, patch testing cannot identify the extent of corrosion, autoinflammatory reactions, and foreign body reactions that can occur.

We must keep an open mind in patients who have implanted devices and have unusual or otherwise undefined symptoms. Often, the symptoms do not directly correspond to the site of implantation and the only way to discern whether the implant is the cause and to treat symptoms is removal of the implanted device.

Dr. Wesley and Dr. Talakoub are cocontributors to this column. Dr. Wesley practices dermatology in Beverly Hills, Calif. Dr. Talakoub is in private practice in McLean, Va. This month’s column is by Dr. Talakoub. Write to them at [email protected]. They had no relevant disclosures.

 

References

Food and Drug Administration. Biological Responses to Metal Implants. 2019 Sep. https://www.fda.gov/media/131150/download.

Atwater AR, Reeder M. Cutis. 2020 Feb;105(2):68-70.

Schalock PC et al. Dermatitis. Sep-Oct 2016;27(5):241-7.

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Hypersensitivity to implantable devices, albeit rare, is a growing problem. Cutaneous and noncutaneous reactions can occur secondary to metals and metal alloys, according to a report on biological responses to metal implants released by the Food and Drug Administration in September 2019. Large controlled studies are lacking, and the FDA has initiated extensive postmarketing reviews of certain metal implants in response to safety concerns. Further research is needed on the composition of these implants, the diverse spectrum of metals used, the physical environment in which they are implanted, and the immune response associated with implants.

Dr. Lily Talakoub

Local and systemic type IV hypersensitivity reactions can result from exposure to metal ions, which are thought to act as haptens and bind to proteins. The hapten-protein complex acts as the antigen for the T cell. Additionally, both acute and chronic inflammatory responses secondary to wound healing and foreign body reactions can occur. Neutrophils and macrophages elicit a tissue response, which can cause aseptic infection, loosening of joints, and tissue damage. Furthermore, corrosion of metal implants can lead to release of metal ions, which can have genotoxic and carcinogenic effects.

Clinical and subclinical effects of implantable devices depend on the device itself, the composition of the device, the tissue type, and an individual’s immune characteristics. Metal debris released from implants can activate innate and adaptive immune responses through a variety of different mechanisms, depending on the implant type and in what tissues the implant is placed. In the case of orthopedic implants, the most common implants, osteoclasts can sense metal and induce proinflammatory cytokines, which can result in corrosion and uptake of metal particles. Metal devices used in the central nervous system, such as intracerebral electrodes, can cause inflammatory responses leading to tissue encapsulation of electrodes. Corrosion of electrodes and release of metal ions can also impede ion channels in the CNS, blocking critical neuron-signaling pathways. Inflammatory reactions surrounding cardiac and vascular implants containing metal activate coagulation cascades, resulting in endothelial injury and activation of thrombi.

Despite the commonly used term “metal allergy” that delineates a type IV hypersensitivity reaction, reports in the literature supports the existence of both innate and adaptive immune responses to metal implanted in tissues. The recommended terminology is “adverse reactions to metal debris.” The clinical presentation may not be straightforward or easily attributed to the implant. Diagnostic tools are limited and may not detect a causal relationship.

Dr. Naissan O. Wesley

Clinical symptoms can range from local rashes and pruritus to cardiac damage, depression, vertigo, and neurologic symptoms; autoimmune/autoinflammatory reactions including chronic fatigue and autoimmune-like systemic symptoms, such as joint pain, headaches, and hair loss, have also been reported in association with implants containing metal. In addition to pruritus, dermatologic manifestations can include erythema, edema, papules, vesicles, as well as systemic hypersensitivity reactions. Typically, cutaneous reactions usually present within 2 days to 24 months of implantation and may be considered surgical-site infections. Although these reactions can be treated with topical or oral corticosteroids, removal of the device is frequently needed for complete clearance.

In clinical practice, it has been frustrating that potential adverse reactions to metal implants are often overlooked because they are thought to be so rare. There are case series documenting metal implant hypersensitivity, but the actual prevalence of hypersensitivity or autoinflammatory reactions is not known. Testing methods are often inaccurate; therefore, identification of at-risk individuals and management of symptomatic patients with implants is important.

The 2016 American Contact Dermatitis Society guidelines do not recommend preimplantation patch testing unless there is a suspected metal allergy. However, patch testing cannot identify the extent of corrosion, autoinflammatory reactions, and foreign body reactions that can occur.

We must keep an open mind in patients who have implanted devices and have unusual or otherwise undefined symptoms. Often, the symptoms do not directly correspond to the site of implantation and the only way to discern whether the implant is the cause and to treat symptoms is removal of the implanted device.

Dr. Wesley and Dr. Talakoub are cocontributors to this column. Dr. Wesley practices dermatology in Beverly Hills, Calif. Dr. Talakoub is in private practice in McLean, Va. This month’s column is by Dr. Talakoub. Write to them at [email protected]. They had no relevant disclosures.

 

References

Food and Drug Administration. Biological Responses to Metal Implants. 2019 Sep. https://www.fda.gov/media/131150/download.

Atwater AR, Reeder M. Cutis. 2020 Feb;105(2):68-70.

Schalock PC et al. Dermatitis. Sep-Oct 2016;27(5):241-7.

Hypersensitivity to implantable devices, albeit rare, is a growing problem. Cutaneous and noncutaneous reactions can occur secondary to metals and metal alloys, according to a report on biological responses to metal implants released by the Food and Drug Administration in September 2019. Large controlled studies are lacking, and the FDA has initiated extensive postmarketing reviews of certain metal implants in response to safety concerns. Further research is needed on the composition of these implants, the diverse spectrum of metals used, the physical environment in which they are implanted, and the immune response associated with implants.

Dr. Lily Talakoub

Local and systemic type IV hypersensitivity reactions can result from exposure to metal ions, which are thought to act as haptens and bind to proteins. The hapten-protein complex acts as the antigen for the T cell. Additionally, both acute and chronic inflammatory responses secondary to wound healing and foreign body reactions can occur. Neutrophils and macrophages elicit a tissue response, which can cause aseptic infection, loosening of joints, and tissue damage. Furthermore, corrosion of metal implants can lead to release of metal ions, which can have genotoxic and carcinogenic effects.

Clinical and subclinical effects of implantable devices depend on the device itself, the composition of the device, the tissue type, and an individual’s immune characteristics. Metal debris released from implants can activate innate and adaptive immune responses through a variety of different mechanisms, depending on the implant type and in what tissues the implant is placed. In the case of orthopedic implants, the most common implants, osteoclasts can sense metal and induce proinflammatory cytokines, which can result in corrosion and uptake of metal particles. Metal devices used in the central nervous system, such as intracerebral electrodes, can cause inflammatory responses leading to tissue encapsulation of electrodes. Corrosion of electrodes and release of metal ions can also impede ion channels in the CNS, blocking critical neuron-signaling pathways. Inflammatory reactions surrounding cardiac and vascular implants containing metal activate coagulation cascades, resulting in endothelial injury and activation of thrombi.

Despite the commonly used term “metal allergy” that delineates a type IV hypersensitivity reaction, reports in the literature supports the existence of both innate and adaptive immune responses to metal implanted in tissues. The recommended terminology is “adverse reactions to metal debris.” The clinical presentation may not be straightforward or easily attributed to the implant. Diagnostic tools are limited and may not detect a causal relationship.

Dr. Naissan O. Wesley

Clinical symptoms can range from local rashes and pruritus to cardiac damage, depression, vertigo, and neurologic symptoms; autoimmune/autoinflammatory reactions including chronic fatigue and autoimmune-like systemic symptoms, such as joint pain, headaches, and hair loss, have also been reported in association with implants containing metal. In addition to pruritus, dermatologic manifestations can include erythema, edema, papules, vesicles, as well as systemic hypersensitivity reactions. Typically, cutaneous reactions usually present within 2 days to 24 months of implantation and may be considered surgical-site infections. Although these reactions can be treated with topical or oral corticosteroids, removal of the device is frequently needed for complete clearance.

In clinical practice, it has been frustrating that potential adverse reactions to metal implants are often overlooked because they are thought to be so rare. There are case series documenting metal implant hypersensitivity, but the actual prevalence of hypersensitivity or autoinflammatory reactions is not known. Testing methods are often inaccurate; therefore, identification of at-risk individuals and management of symptomatic patients with implants is important.

The 2016 American Contact Dermatitis Society guidelines do not recommend preimplantation patch testing unless there is a suspected metal allergy. However, patch testing cannot identify the extent of corrosion, autoinflammatory reactions, and foreign body reactions that can occur.

We must keep an open mind in patients who have implanted devices and have unusual or otherwise undefined symptoms. Often, the symptoms do not directly correspond to the site of implantation and the only way to discern whether the implant is the cause and to treat symptoms is removal of the implanted device.

Dr. Wesley and Dr. Talakoub are cocontributors to this column. Dr. Wesley practices dermatology in Beverly Hills, Calif. Dr. Talakoub is in private practice in McLean, Va. This month’s column is by Dr. Talakoub. Write to them at [email protected]. They had no relevant disclosures.

 

References

Food and Drug Administration. Biological Responses to Metal Implants. 2019 Sep. https://www.fda.gov/media/131150/download.

Atwater AR, Reeder M. Cutis. 2020 Feb;105(2):68-70.

Schalock PC et al. Dermatitis. Sep-Oct 2016;27(5):241-7.

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NBA star Mason Plumlee on COVID and life inside the Orlando ‘bubble’

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Editor’s Note: This transcript from the August 20 episode of the Blood & Cancer podcast has been edited for clarity. Click this link to listen to the full episode.

David Henry, MD: Welcome to this Blood & Cancer podcast. I’m your host, Dr. David Henry. This podcast airs on Thursday morning each week. This interview and others are archived with show notes from our residents at Pennsylvania Hospital at this link.

Each week we interview key opinion leaders involved in various aspects of blood and cancer. Today, we have a different kind of key opinion leader, as I have the privilege of interviewing Mason Plumlee, a forward with the National Basketball Association’s (NBA) Denver Nuggets. Mason was a first round pick in the NBA, a gold medalist for the U.S. men’s national team, and NBA All-Rookie first team honoree. He’s one of the top playmaking forwards in the country, if not the world, in my opinion. In his four-year college career at Duke University, he helped lead the Blue Devils to a National Collegiate Athletic Association (NCAA) championship and twice earned All-America first team academic honors at Duke. So he’s not just a basketball star, but an academic star as well. Mason, thanks so much for taking some time out from the bubble in Florida to talk with us today.
 

Mason Plumlee: Thanks for having me on. I’m happy to be here.

Henry: Beginning in March, the NBA didn’t know what to do about the COVID pandemic but finally decided to put you professional players in a ‘bubble.’ What did you have to go through to get there? You, your teammates, coaches, trainers, etc. And what’s the ongoing plan to be sure you continue to be safe?

Plumlee: Back to when the season shut down in March, the NBA shut down the practice facilities at the same time. Most people went home. I went back to Indiana. And then, as the idea of this bubble came up and the NBA formalized a plan to start the season again, players started to go back to market. I went back to Denver and was working out there.

About two weeks before we were scheduled to arrive in Orlando, they started testing us every other day. They used the deep nasal swab as well as the throat swab. But they were also taking two to three blood tests in that time period. You needed a certain number of consecutive negative tests before they would allow you to fly on the team plane down to Orlando. So there was an incredible amount of testing in the market. Once you got to Orlando, you went into a 48-hour quarantine. You had to have two negative tests with 48 hours between them before you could leave your hotel room.

Since then, it’s been quite strict down here. And although it’s annoying in a lot of ways, I think it’s one of the reasons our league has been able to pull this off. We’ve had no positive tests within the bubble and we are tested every day. A company called BioReference Laboratories has a setup in one of the meeting rooms here, and it’s like clockwork—we go in, we get our tests. One of my teammates missed a test and they made him stay in his room until he could get another test and get the results, so he missed a game because of that.
 

Henry: During this bubble time, no one has tested positive—players, coaches, staff?

Plumlee: Correct.

Henry: That’s incredible, and it’s allowed those of us who want to watch the NBA and those of you who are in it professionally to continue the sport. It must be a real nuisance for you and your family and friends, because no one can visit you, right?

Plumlee: Right. There’s no visitation. We had one false positive. It was our media relations person and the actions they took when that positive test came in -- they quarantined him in his room and interviewed everybody he had talked to; they tested anyone who had any interaction with him and those people had to go into quarantine. They’re on top of things down here. In addition to the testing, we each have a pulse oximeter and a thermometer, and we use these to check in everyday on an app. So, they’re getting all the insight they need. After the first round of the playoffs, they’re going to open the bubble to friends and family, but those friends and family will be subject to all the same protocols that we were coming in and once they’re here as well.

Henry: I’m sure you’ve heard about the Broadway star [Nick Cordero] who was healthy and suddenly got sick, lost a leg, and then lost his life. There have been some heart attacks that surprised us. Have your colleagues—players, coaches, etc.—been worried? Or are they thinking, what’s the big deal? Has the sense of how serious this is permeated through this sport?

Plumlee: The NBA is one of the groups that has heightened the understanding and awareness of this by shutting down. I think a lot of people were moving forward as is, and then, when the NBA decided to cancel the season, it let the world know, look, this is to be taken seriously.

Henry: A couple of players did test positive early on.

Plumlee: Exactly. A couple of people tested positive. I think at the outset, the unknown is always scarier. As we’ve learned more about the virus, the guys have become more comfortable. You know, I tested positive back in March. At the time, a loss of taste and smell was not a reported symptom.

Henry: And you had that?

Plumlee: I did have that, but I didn’t know what to think. More research has come out and we have a better understanding of that. I think most of the players are comfortable with the virus. We’re at a time in our lives where we’re healthy, we’re active, and we should be able to fight it off. We know the numbers for our age group. Even still, I think nobody wants to get it. Nobody wants to have to go through it. So why chance it?

Henry: Hats off to you and your sport. Other sports such as Major League Baseball haven’t been quite so successful. Of course, they’re wrestling with the players testing positive, and this has stopped games this season.

I was looking over your background prior to the interview and learned that your mother and father have been involved in the medical arena. Can you tell us about that and how it’s rubbed off on you?

 

 

Plumlee: Definitely. My mom is a pharmacist, so I spent a lot of time as a kid going to see her at work. And my dad is general counsel for an orthopedic company. My hometown is Warsaw, Ind. Some people refer to it as the “Orthopedic Capital of the World.” Zimmer Biomet is headquartered there. DePuy Synthes is there. Medtronic has offices there, as well as a lot of cottage businesses that support the orthopedic industry. In my hometown, the rock star was Dane Miller, who founded Biomet. I have no formal education in medicine or health care, but I’ve seen the impact of it. From my parents and some cousins, uncles who are doctors and surgeons, it’s been interesting to see their work and learn about what’s the latest and greatest in health care.

Henry: What’s so nice about you in particular is, with that background of interests from your family and your celebrity and accomplishments in professional basketball, you have used that to explore and promote ways to make progress in health care and help others who are less fortunate. For example, you’re involved in a telehealth platform for all-in-one practice management; affordable telehealth for pediatrics; health benefits for small businesses; prior authorization—if you can help with prior authorization, we will be in the stands for you at every game because it’s the bane of our existence; radiotherapy; and probably from mom’s background, pharmacy benefit management. Pick any of those you’d like to talk about, and tell us about your involvement and how it’s going.

Plumlee: My ticket into the arena is investment. Nobody’s calling me, asking for my expertise. But a lot of these visionary founders need financial support, and that’s where I get involved. Then also, with the celebrity angle from being an athlete, sometimes you can open doors for a start-up founder that they may not be able to open themselves.

I’m happy to speak about any of those companies. I am excited about the relaxed regulation that’s come from the pandemic; not that it’s like the Wild West out here, but I think it has allowed companies to implement solutions or think about problems in a way that they couldn’t before the pandemic. Take the prior authorization play, for example, and a company called Banjo Health, with one of my favorite founders, a guy named Saar Mahna. Medicare mandates that you turn around prior authorizations within three days. This company has an artificial intelligence and machine-learning play on prior authorizations that can deliver on that.

So efficiencies, things that increase access or affordability, better outcomes, those are the things that attract me. I lean on other people for the due diligence. The pediatric play that you referenced is a company called Blueberry Pediatrics. You have a monthly subscription for $15 that can be reimbursed by Medicaid. They send two devices to your home—an otoscope and an oximeter. The company is live in Florida right now, and it’s diverting a ton of emergency room (ER) visits. From home, for $15 a month, a mom has an otoscope and an oximeter, and she can chat or video conference with a pediatrician. There’s no additional fee. So that’s saving everyone time and saving the system money. Those are the kinds of things I’m attracted to.

Henry: You’ve touched on a couple of hot button issues for us. In oncology, unfortunately, most of our patients have pain. I am mystified every time I try to get a narcotic or a strong painkiller for a patient on a Friday night and I’m told it requires prior authorization and they’ll open up again on Monday. Well, that’s insane. These patients need something right away. So if you have a special interest in helping all of us with prior authorization, the artificial intelligence is a no brainer. If this kind of computer algorithm could happen overnight, that would be wonderful.

You mentioned the ER. Many people go to the ER as a default. They don’t know what else to do. In the COVID era, we’re trying to dial that down because we want to be able to see the sickest and have the non-sick get care elsewhere. If this particular person or people don’t know what to do, they go to the ER, it costs money, takes a lot of time, and others who may be sick are diverted from care. Families worry terribly about their children, so a device for mom and access to a pediatrician for $15 a month is another wonderful idea. These are both very interesting. Another company is in the pharmacy benefit management (PBM) space. Anything you could say about how that works?
 

Plumlee: I can give an overview of how I look at this as an investor in the PBM space. Three companies control about 75% of a multibillion dollar market. Several initiatives have been pursued politically to provide transparent pricing between these PBMs and pharmaceutical companies, and a lot of people are pointing fingers, but ultimately, drug prices just keep going up. Everybody knows it.

A couple of start-up founders are really set on bringing a competitive marketplace back to the pharmacy benefit manager. As an investor, when you see three people controlling a market, and you have small or medium PBMs that depend on aggregators to get competitive pricing with those big three, you get interested. It’s an interesting industry. My feeling is that somebody is going to disrupt it and bring competition back to that space. Ultimately, drug prices will come down because it’s not sustainable. The insurance companies just accommodate whatever the drug pricing is. If the drug prices go up, your premiums go up. I think these new companies will be level-setting.
 

Henry: In my world of oncology, we’re just a little more than halfway through 2020 and we’ve had five, six, seven new drugs approved. They all will be very expensive. One of the nicer things that’s happening and may help to tamp this down involves biosimilars. When you go to CVS or Rite Aid, you go down the aspirin aisle and see the generics, and they’re identical to the brand name aspirin. Well, these very complex molecules we used to treat cancer are antibodies or proteins, and they’re made in nature’s factories called cells. They’re not identical to the brand name drugs, but they’re called biosimilars. They work exactly the same as the branded drugs with exactly the same safety–our U.S. FDA has done a nice job of vetting that, to be sure. X, Y, Z Company has copied the brand drug after the patent expires. They were hoping for about a 30% discount in price but we’re seeing more like 15%. Nothing’s ever easy. So you make a very good point. This is not sustainable and the competition will be wonderful to tamp down these prices.

 

 

Plumlee: My hope is that those biosimilars and generics get placement in these formularies because the formularies are what’s valuable to the drug manufacturers. But they have to accommodate what the Big Three want in the PBM space. To me, making things affordable and accessible is what a lot of these startups are trying to do. And hopefully they will win.

Henry: What have you been going through, in terms of COVID? Have you recovered fully? Have your taste and smell returned, and you’re back to normal?

Plumlee: I’m all good. It caught me off guard but the symptoms weren’t too intense. For me, it was less than a flu, but more than a cold. And I’m all good today.

Henry: We’re so glad and wish you the best of luck.

Dr. Henry is a clinical professor of medicine at the University of Pennsylvania and vice chairman of the department of medicine at Pennsylvania Hospital in Philadelphia and the host of the Blood & Cancer podcast. He has no relevant financial conflicts.

Mr. Plumlee is a board advisor to both Formsense and the Prysm Institute and a board observer with Voiceitt.

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Editor’s Note: This transcript from the August 20 episode of the Blood & Cancer podcast has been edited for clarity. Click this link to listen to the full episode.

David Henry, MD: Welcome to this Blood & Cancer podcast. I’m your host, Dr. David Henry. This podcast airs on Thursday morning each week. This interview and others are archived with show notes from our residents at Pennsylvania Hospital at this link.

Each week we interview key opinion leaders involved in various aspects of blood and cancer. Today, we have a different kind of key opinion leader, as I have the privilege of interviewing Mason Plumlee, a forward with the National Basketball Association’s (NBA) Denver Nuggets. Mason was a first round pick in the NBA, a gold medalist for the U.S. men’s national team, and NBA All-Rookie first team honoree. He’s one of the top playmaking forwards in the country, if not the world, in my opinion. In his four-year college career at Duke University, he helped lead the Blue Devils to a National Collegiate Athletic Association (NCAA) championship and twice earned All-America first team academic honors at Duke. So he’s not just a basketball star, but an academic star as well. Mason, thanks so much for taking some time out from the bubble in Florida to talk with us today.
 

Mason Plumlee: Thanks for having me on. I’m happy to be here.

Henry: Beginning in March, the NBA didn’t know what to do about the COVID pandemic but finally decided to put you professional players in a ‘bubble.’ What did you have to go through to get there? You, your teammates, coaches, trainers, etc. And what’s the ongoing plan to be sure you continue to be safe?

Plumlee: Back to when the season shut down in March, the NBA shut down the practice facilities at the same time. Most people went home. I went back to Indiana. And then, as the idea of this bubble came up and the NBA formalized a plan to start the season again, players started to go back to market. I went back to Denver and was working out there.

About two weeks before we were scheduled to arrive in Orlando, they started testing us every other day. They used the deep nasal swab as well as the throat swab. But they were also taking two to three blood tests in that time period. You needed a certain number of consecutive negative tests before they would allow you to fly on the team plane down to Orlando. So there was an incredible amount of testing in the market. Once you got to Orlando, you went into a 48-hour quarantine. You had to have two negative tests with 48 hours between them before you could leave your hotel room.

Since then, it’s been quite strict down here. And although it’s annoying in a lot of ways, I think it’s one of the reasons our league has been able to pull this off. We’ve had no positive tests within the bubble and we are tested every day. A company called BioReference Laboratories has a setup in one of the meeting rooms here, and it’s like clockwork—we go in, we get our tests. One of my teammates missed a test and they made him stay in his room until he could get another test and get the results, so he missed a game because of that.
 

Henry: During this bubble time, no one has tested positive—players, coaches, staff?

Plumlee: Correct.

Henry: That’s incredible, and it’s allowed those of us who want to watch the NBA and those of you who are in it professionally to continue the sport. It must be a real nuisance for you and your family and friends, because no one can visit you, right?

Plumlee: Right. There’s no visitation. We had one false positive. It was our media relations person and the actions they took when that positive test came in -- they quarantined him in his room and interviewed everybody he had talked to; they tested anyone who had any interaction with him and those people had to go into quarantine. They’re on top of things down here. In addition to the testing, we each have a pulse oximeter and a thermometer, and we use these to check in everyday on an app. So, they’re getting all the insight they need. After the first round of the playoffs, they’re going to open the bubble to friends and family, but those friends and family will be subject to all the same protocols that we were coming in and once they’re here as well.

Henry: I’m sure you’ve heard about the Broadway star [Nick Cordero] who was healthy and suddenly got sick, lost a leg, and then lost his life. There have been some heart attacks that surprised us. Have your colleagues—players, coaches, etc.—been worried? Or are they thinking, what’s the big deal? Has the sense of how serious this is permeated through this sport?

Plumlee: The NBA is one of the groups that has heightened the understanding and awareness of this by shutting down. I think a lot of people were moving forward as is, and then, when the NBA decided to cancel the season, it let the world know, look, this is to be taken seriously.

Henry: A couple of players did test positive early on.

Plumlee: Exactly. A couple of people tested positive. I think at the outset, the unknown is always scarier. As we’ve learned more about the virus, the guys have become more comfortable. You know, I tested positive back in March. At the time, a loss of taste and smell was not a reported symptom.

Henry: And you had that?

Plumlee: I did have that, but I didn’t know what to think. More research has come out and we have a better understanding of that. I think most of the players are comfortable with the virus. We’re at a time in our lives where we’re healthy, we’re active, and we should be able to fight it off. We know the numbers for our age group. Even still, I think nobody wants to get it. Nobody wants to have to go through it. So why chance it?

Henry: Hats off to you and your sport. Other sports such as Major League Baseball haven’t been quite so successful. Of course, they’re wrestling with the players testing positive, and this has stopped games this season.

I was looking over your background prior to the interview and learned that your mother and father have been involved in the medical arena. Can you tell us about that and how it’s rubbed off on you?

 

 

Plumlee: Definitely. My mom is a pharmacist, so I spent a lot of time as a kid going to see her at work. And my dad is general counsel for an orthopedic company. My hometown is Warsaw, Ind. Some people refer to it as the “Orthopedic Capital of the World.” Zimmer Biomet is headquartered there. DePuy Synthes is there. Medtronic has offices there, as well as a lot of cottage businesses that support the orthopedic industry. In my hometown, the rock star was Dane Miller, who founded Biomet. I have no formal education in medicine or health care, but I’ve seen the impact of it. From my parents and some cousins, uncles who are doctors and surgeons, it’s been interesting to see their work and learn about what’s the latest and greatest in health care.

Henry: What’s so nice about you in particular is, with that background of interests from your family and your celebrity and accomplishments in professional basketball, you have used that to explore and promote ways to make progress in health care and help others who are less fortunate. For example, you’re involved in a telehealth platform for all-in-one practice management; affordable telehealth for pediatrics; health benefits for small businesses; prior authorization—if you can help with prior authorization, we will be in the stands for you at every game because it’s the bane of our existence; radiotherapy; and probably from mom’s background, pharmacy benefit management. Pick any of those you’d like to talk about, and tell us about your involvement and how it’s going.

Plumlee: My ticket into the arena is investment. Nobody’s calling me, asking for my expertise. But a lot of these visionary founders need financial support, and that’s where I get involved. Then also, with the celebrity angle from being an athlete, sometimes you can open doors for a start-up founder that they may not be able to open themselves.

I’m happy to speak about any of those companies. I am excited about the relaxed regulation that’s come from the pandemic; not that it’s like the Wild West out here, but I think it has allowed companies to implement solutions or think about problems in a way that they couldn’t before the pandemic. Take the prior authorization play, for example, and a company called Banjo Health, with one of my favorite founders, a guy named Saar Mahna. Medicare mandates that you turn around prior authorizations within three days. This company has an artificial intelligence and machine-learning play on prior authorizations that can deliver on that.

So efficiencies, things that increase access or affordability, better outcomes, those are the things that attract me. I lean on other people for the due diligence. The pediatric play that you referenced is a company called Blueberry Pediatrics. You have a monthly subscription for $15 that can be reimbursed by Medicaid. They send two devices to your home—an otoscope and an oximeter. The company is live in Florida right now, and it’s diverting a ton of emergency room (ER) visits. From home, for $15 a month, a mom has an otoscope and an oximeter, and she can chat or video conference with a pediatrician. There’s no additional fee. So that’s saving everyone time and saving the system money. Those are the kinds of things I’m attracted to.

Henry: You’ve touched on a couple of hot button issues for us. In oncology, unfortunately, most of our patients have pain. I am mystified every time I try to get a narcotic or a strong painkiller for a patient on a Friday night and I’m told it requires prior authorization and they’ll open up again on Monday. Well, that’s insane. These patients need something right away. So if you have a special interest in helping all of us with prior authorization, the artificial intelligence is a no brainer. If this kind of computer algorithm could happen overnight, that would be wonderful.

You mentioned the ER. Many people go to the ER as a default. They don’t know what else to do. In the COVID era, we’re trying to dial that down because we want to be able to see the sickest and have the non-sick get care elsewhere. If this particular person or people don’t know what to do, they go to the ER, it costs money, takes a lot of time, and others who may be sick are diverted from care. Families worry terribly about their children, so a device for mom and access to a pediatrician for $15 a month is another wonderful idea. These are both very interesting. Another company is in the pharmacy benefit management (PBM) space. Anything you could say about how that works?
 

Plumlee: I can give an overview of how I look at this as an investor in the PBM space. Three companies control about 75% of a multibillion dollar market. Several initiatives have been pursued politically to provide transparent pricing between these PBMs and pharmaceutical companies, and a lot of people are pointing fingers, but ultimately, drug prices just keep going up. Everybody knows it.

A couple of start-up founders are really set on bringing a competitive marketplace back to the pharmacy benefit manager. As an investor, when you see three people controlling a market, and you have small or medium PBMs that depend on aggregators to get competitive pricing with those big three, you get interested. It’s an interesting industry. My feeling is that somebody is going to disrupt it and bring competition back to that space. Ultimately, drug prices will come down because it’s not sustainable. The insurance companies just accommodate whatever the drug pricing is. If the drug prices go up, your premiums go up. I think these new companies will be level-setting.
 

Henry: In my world of oncology, we’re just a little more than halfway through 2020 and we’ve had five, six, seven new drugs approved. They all will be very expensive. One of the nicer things that’s happening and may help to tamp this down involves biosimilars. When you go to CVS or Rite Aid, you go down the aspirin aisle and see the generics, and they’re identical to the brand name aspirin. Well, these very complex molecules we used to treat cancer are antibodies or proteins, and they’re made in nature’s factories called cells. They’re not identical to the brand name drugs, but they’re called biosimilars. They work exactly the same as the branded drugs with exactly the same safety–our U.S. FDA has done a nice job of vetting that, to be sure. X, Y, Z Company has copied the brand drug after the patent expires. They were hoping for about a 30% discount in price but we’re seeing more like 15%. Nothing’s ever easy. So you make a very good point. This is not sustainable and the competition will be wonderful to tamp down these prices.

 

 

Plumlee: My hope is that those biosimilars and generics get placement in these formularies because the formularies are what’s valuable to the drug manufacturers. But they have to accommodate what the Big Three want in the PBM space. To me, making things affordable and accessible is what a lot of these startups are trying to do. And hopefully they will win.

Henry: What have you been going through, in terms of COVID? Have you recovered fully? Have your taste and smell returned, and you’re back to normal?

Plumlee: I’m all good. It caught me off guard but the symptoms weren’t too intense. For me, it was less than a flu, but more than a cold. And I’m all good today.

Henry: We’re so glad and wish you the best of luck.

Dr. Henry is a clinical professor of medicine at the University of Pennsylvania and vice chairman of the department of medicine at Pennsylvania Hospital in Philadelphia and the host of the Blood & Cancer podcast. He has no relevant financial conflicts.

Mr. Plumlee is a board advisor to both Formsense and the Prysm Institute and a board observer with Voiceitt.

Editor’s Note: This transcript from the August 20 episode of the Blood & Cancer podcast has been edited for clarity. Click this link to listen to the full episode.

David Henry, MD: Welcome to this Blood & Cancer podcast. I’m your host, Dr. David Henry. This podcast airs on Thursday morning each week. This interview and others are archived with show notes from our residents at Pennsylvania Hospital at this link.

Each week we interview key opinion leaders involved in various aspects of blood and cancer. Today, we have a different kind of key opinion leader, as I have the privilege of interviewing Mason Plumlee, a forward with the National Basketball Association’s (NBA) Denver Nuggets. Mason was a first round pick in the NBA, a gold medalist for the U.S. men’s national team, and NBA All-Rookie first team honoree. He’s one of the top playmaking forwards in the country, if not the world, in my opinion. In his four-year college career at Duke University, he helped lead the Blue Devils to a National Collegiate Athletic Association (NCAA) championship and twice earned All-America first team academic honors at Duke. So he’s not just a basketball star, but an academic star as well. Mason, thanks so much for taking some time out from the bubble in Florida to talk with us today.
 

Mason Plumlee: Thanks for having me on. I’m happy to be here.

Henry: Beginning in March, the NBA didn’t know what to do about the COVID pandemic but finally decided to put you professional players in a ‘bubble.’ What did you have to go through to get there? You, your teammates, coaches, trainers, etc. And what’s the ongoing plan to be sure you continue to be safe?

Plumlee: Back to when the season shut down in March, the NBA shut down the practice facilities at the same time. Most people went home. I went back to Indiana. And then, as the idea of this bubble came up and the NBA formalized a plan to start the season again, players started to go back to market. I went back to Denver and was working out there.

About two weeks before we were scheduled to arrive in Orlando, they started testing us every other day. They used the deep nasal swab as well as the throat swab. But they were also taking two to three blood tests in that time period. You needed a certain number of consecutive negative tests before they would allow you to fly on the team plane down to Orlando. So there was an incredible amount of testing in the market. Once you got to Orlando, you went into a 48-hour quarantine. You had to have two negative tests with 48 hours between them before you could leave your hotel room.

Since then, it’s been quite strict down here. And although it’s annoying in a lot of ways, I think it’s one of the reasons our league has been able to pull this off. We’ve had no positive tests within the bubble and we are tested every day. A company called BioReference Laboratories has a setup in one of the meeting rooms here, and it’s like clockwork—we go in, we get our tests. One of my teammates missed a test and they made him stay in his room until he could get another test and get the results, so he missed a game because of that.
 

Henry: During this bubble time, no one has tested positive—players, coaches, staff?

Plumlee: Correct.

Henry: That’s incredible, and it’s allowed those of us who want to watch the NBA and those of you who are in it professionally to continue the sport. It must be a real nuisance for you and your family and friends, because no one can visit you, right?

Plumlee: Right. There’s no visitation. We had one false positive. It was our media relations person and the actions they took when that positive test came in -- they quarantined him in his room and interviewed everybody he had talked to; they tested anyone who had any interaction with him and those people had to go into quarantine. They’re on top of things down here. In addition to the testing, we each have a pulse oximeter and a thermometer, and we use these to check in everyday on an app. So, they’re getting all the insight they need. After the first round of the playoffs, they’re going to open the bubble to friends and family, but those friends and family will be subject to all the same protocols that we were coming in and once they’re here as well.

Henry: I’m sure you’ve heard about the Broadway star [Nick Cordero] who was healthy and suddenly got sick, lost a leg, and then lost his life. There have been some heart attacks that surprised us. Have your colleagues—players, coaches, etc.—been worried? Or are they thinking, what’s the big deal? Has the sense of how serious this is permeated through this sport?

Plumlee: The NBA is one of the groups that has heightened the understanding and awareness of this by shutting down. I think a lot of people were moving forward as is, and then, when the NBA decided to cancel the season, it let the world know, look, this is to be taken seriously.

Henry: A couple of players did test positive early on.

Plumlee: Exactly. A couple of people tested positive. I think at the outset, the unknown is always scarier. As we’ve learned more about the virus, the guys have become more comfortable. You know, I tested positive back in March. At the time, a loss of taste and smell was not a reported symptom.

Henry: And you had that?

Plumlee: I did have that, but I didn’t know what to think. More research has come out and we have a better understanding of that. I think most of the players are comfortable with the virus. We’re at a time in our lives where we’re healthy, we’re active, and we should be able to fight it off. We know the numbers for our age group. Even still, I think nobody wants to get it. Nobody wants to have to go through it. So why chance it?

Henry: Hats off to you and your sport. Other sports such as Major League Baseball haven’t been quite so successful. Of course, they’re wrestling with the players testing positive, and this has stopped games this season.

I was looking over your background prior to the interview and learned that your mother and father have been involved in the medical arena. Can you tell us about that and how it’s rubbed off on you?

 

 

Plumlee: Definitely. My mom is a pharmacist, so I spent a lot of time as a kid going to see her at work. And my dad is general counsel for an orthopedic company. My hometown is Warsaw, Ind. Some people refer to it as the “Orthopedic Capital of the World.” Zimmer Biomet is headquartered there. DePuy Synthes is there. Medtronic has offices there, as well as a lot of cottage businesses that support the orthopedic industry. In my hometown, the rock star was Dane Miller, who founded Biomet. I have no formal education in medicine or health care, but I’ve seen the impact of it. From my parents and some cousins, uncles who are doctors and surgeons, it’s been interesting to see their work and learn about what’s the latest and greatest in health care.

Henry: What’s so nice about you in particular is, with that background of interests from your family and your celebrity and accomplishments in professional basketball, you have used that to explore and promote ways to make progress in health care and help others who are less fortunate. For example, you’re involved in a telehealth platform for all-in-one practice management; affordable telehealth for pediatrics; health benefits for small businesses; prior authorization—if you can help with prior authorization, we will be in the stands for you at every game because it’s the bane of our existence; radiotherapy; and probably from mom’s background, pharmacy benefit management. Pick any of those you’d like to talk about, and tell us about your involvement and how it’s going.

Plumlee: My ticket into the arena is investment. Nobody’s calling me, asking for my expertise. But a lot of these visionary founders need financial support, and that’s where I get involved. Then also, with the celebrity angle from being an athlete, sometimes you can open doors for a start-up founder that they may not be able to open themselves.

I’m happy to speak about any of those companies. I am excited about the relaxed regulation that’s come from the pandemic; not that it’s like the Wild West out here, but I think it has allowed companies to implement solutions or think about problems in a way that they couldn’t before the pandemic. Take the prior authorization play, for example, and a company called Banjo Health, with one of my favorite founders, a guy named Saar Mahna. Medicare mandates that you turn around prior authorizations within three days. This company has an artificial intelligence and machine-learning play on prior authorizations that can deliver on that.

So efficiencies, things that increase access or affordability, better outcomes, those are the things that attract me. I lean on other people for the due diligence. The pediatric play that you referenced is a company called Blueberry Pediatrics. You have a monthly subscription for $15 that can be reimbursed by Medicaid. They send two devices to your home—an otoscope and an oximeter. The company is live in Florida right now, and it’s diverting a ton of emergency room (ER) visits. From home, for $15 a month, a mom has an otoscope and an oximeter, and she can chat or video conference with a pediatrician. There’s no additional fee. So that’s saving everyone time and saving the system money. Those are the kinds of things I’m attracted to.

Henry: You’ve touched on a couple of hot button issues for us. In oncology, unfortunately, most of our patients have pain. I am mystified every time I try to get a narcotic or a strong painkiller for a patient on a Friday night and I’m told it requires prior authorization and they’ll open up again on Monday. Well, that’s insane. These patients need something right away. So if you have a special interest in helping all of us with prior authorization, the artificial intelligence is a no brainer. If this kind of computer algorithm could happen overnight, that would be wonderful.

You mentioned the ER. Many people go to the ER as a default. They don’t know what else to do. In the COVID era, we’re trying to dial that down because we want to be able to see the sickest and have the non-sick get care elsewhere. If this particular person or people don’t know what to do, they go to the ER, it costs money, takes a lot of time, and others who may be sick are diverted from care. Families worry terribly about their children, so a device for mom and access to a pediatrician for $15 a month is another wonderful idea. These are both very interesting. Another company is in the pharmacy benefit management (PBM) space. Anything you could say about how that works?
 

Plumlee: I can give an overview of how I look at this as an investor in the PBM space. Three companies control about 75% of a multibillion dollar market. Several initiatives have been pursued politically to provide transparent pricing between these PBMs and pharmaceutical companies, and a lot of people are pointing fingers, but ultimately, drug prices just keep going up. Everybody knows it.

A couple of start-up founders are really set on bringing a competitive marketplace back to the pharmacy benefit manager. As an investor, when you see three people controlling a market, and you have small or medium PBMs that depend on aggregators to get competitive pricing with those big three, you get interested. It’s an interesting industry. My feeling is that somebody is going to disrupt it and bring competition back to that space. Ultimately, drug prices will come down because it’s not sustainable. The insurance companies just accommodate whatever the drug pricing is. If the drug prices go up, your premiums go up. I think these new companies will be level-setting.
 

Henry: In my world of oncology, we’re just a little more than halfway through 2020 and we’ve had five, six, seven new drugs approved. They all will be very expensive. One of the nicer things that’s happening and may help to tamp this down involves biosimilars. When you go to CVS or Rite Aid, you go down the aspirin aisle and see the generics, and they’re identical to the brand name aspirin. Well, these very complex molecules we used to treat cancer are antibodies or proteins, and they’re made in nature’s factories called cells. They’re not identical to the brand name drugs, but they’re called biosimilars. They work exactly the same as the branded drugs with exactly the same safety–our U.S. FDA has done a nice job of vetting that, to be sure. X, Y, Z Company has copied the brand drug after the patent expires. They were hoping for about a 30% discount in price but we’re seeing more like 15%. Nothing’s ever easy. So you make a very good point. This is not sustainable and the competition will be wonderful to tamp down these prices.

 

 

Plumlee: My hope is that those biosimilars and generics get placement in these formularies because the formularies are what’s valuable to the drug manufacturers. But they have to accommodate what the Big Three want in the PBM space. To me, making things affordable and accessible is what a lot of these startups are trying to do. And hopefully they will win.

Henry: What have you been going through, in terms of COVID? Have you recovered fully? Have your taste and smell returned, and you’re back to normal?

Plumlee: I’m all good. It caught me off guard but the symptoms weren’t too intense. For me, it was less than a flu, but more than a cold. And I’m all good today.

Henry: We’re so glad and wish you the best of luck.

Dr. Henry is a clinical professor of medicine at the University of Pennsylvania and vice chairman of the department of medicine at Pennsylvania Hospital in Philadelphia and the host of the Blood & Cancer podcast. He has no relevant financial conflicts.

Mr. Plumlee is a board advisor to both Formsense and the Prysm Institute and a board observer with Voiceitt.

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Age, smoking among leading cancer risk factors for SLE patients

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Thu, 12/15/2022 - 17:35

A new study has quantified cancer risk factors in patients with systemic lupus erythematosus, including smoking and the use of certain medications.

“As expected, older age was associated with cancer overall, as well as with the most common cancer subtypes,” wrote Sasha Bernatsky, MD, PhD, of McGill University, Montreal, and coauthors. The study was published in Arthritis Care & Research.

To determine the risk of cancer in people with clinically confirmed incident systemic lupus erythematosus (SLE), the researchers analyzed data from 1,668 newly diagnosed lupus patients with at least one follow-up visit. All patients were enrolled in the Systemic Lupus International Collaborating Clinics inception cohort from across 33 different centers in North America, Europe, and Asia. A total of 89% (n = 1,480) were women, and 49% (n = 824) were white. The average follow-up period was 9 years.

Of the 1,668 SLE patients, 65 developed some type of cancer. The cancers included 15 breast;, 10 nonmelanoma skin; 7 lung; 6 hematologic, 6 prostate; 5 melanoma; 3 cervical; 3 renal; 2 gastric; 2 head and neck; 2 thyroid; and 1 rectal, sarcoma, thymoma, or uterine. No patient had more than one type, and the mean age of the cancer patients at time of SLE diagnosis was 45.6 (standard deviation, 14.5).



Almost half of the 65 cancers occurred in past or current smokers, including all of the lung cancers, while only 33% of patients without cancers smoked prior to baseline. After univariate analysis, characteristics associated with a higher risk of all cancers included older age at SLE diagnosis (adjusted hazard ratio, 1.05; 95% confidence interval, 1.03-1.06), White race/ethnicity (aHR 1.34; 95% CI, 0.76-2.37), and smoking (aHR 1.21; 95% CI, 0.73-2.01).

After multivariate analysis, the two characteristics most associated with increased cancer risk were older age at SLE diagnosis and being male. The analyses also confirmed that older age was a risk factor for breast cancer (aHR 1.06; 95% CI, 1.02-1.10) and nonmelanoma skin cancer (aHR, 1.06; 95% CI, 1.02-1.11), while use of antimalarial drugs was associated with a lower risk of both breast (aHR, 0.28; 95% CI, 0.09-0.90) and nonmelanoma skin (aHR, 0.23; 95% CI, 0.05-0.95) cancers. For lung cancer, the highest risk factor was smoking 15 or more cigarettes a day (aHR, 6.64; 95% CI, 1.43-30.9); for hematologic cancers, it was being in the top quartile of SLE disease activity (aHR, 7.14; 95% CI, 1.13-45.3).

The authors acknowledged their study’s limitations, including the small number of cancers overall and purposefully not comparing cancer risk in SLE patients with risk in the general population. Although their methods – “physicians recording events at annual visits, confirmed by review of charts” – were recognized as very suitable for the current analysis, they noted that a broader comparison would “potentially be problematic due to differential misclassification error” in cancer registry data.

Two of the study’s authors reported potential conflicts of interest, including receiving grants and consulting and personal fees from various pharmaceutical companies. No other potential conflicts were reported.

SOURCE: Bernatsky S et al. Arthritis Care Res. 2020 Aug 19. doi: 10.1002/acr.24425.

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A new study has quantified cancer risk factors in patients with systemic lupus erythematosus, including smoking and the use of certain medications.

“As expected, older age was associated with cancer overall, as well as with the most common cancer subtypes,” wrote Sasha Bernatsky, MD, PhD, of McGill University, Montreal, and coauthors. The study was published in Arthritis Care & Research.

To determine the risk of cancer in people with clinically confirmed incident systemic lupus erythematosus (SLE), the researchers analyzed data from 1,668 newly diagnosed lupus patients with at least one follow-up visit. All patients were enrolled in the Systemic Lupus International Collaborating Clinics inception cohort from across 33 different centers in North America, Europe, and Asia. A total of 89% (n = 1,480) were women, and 49% (n = 824) were white. The average follow-up period was 9 years.

Of the 1,668 SLE patients, 65 developed some type of cancer. The cancers included 15 breast;, 10 nonmelanoma skin; 7 lung; 6 hematologic, 6 prostate; 5 melanoma; 3 cervical; 3 renal; 2 gastric; 2 head and neck; 2 thyroid; and 1 rectal, sarcoma, thymoma, or uterine. No patient had more than one type, and the mean age of the cancer patients at time of SLE diagnosis was 45.6 (standard deviation, 14.5).



Almost half of the 65 cancers occurred in past or current smokers, including all of the lung cancers, while only 33% of patients without cancers smoked prior to baseline. After univariate analysis, characteristics associated with a higher risk of all cancers included older age at SLE diagnosis (adjusted hazard ratio, 1.05; 95% confidence interval, 1.03-1.06), White race/ethnicity (aHR 1.34; 95% CI, 0.76-2.37), and smoking (aHR 1.21; 95% CI, 0.73-2.01).

After multivariate analysis, the two characteristics most associated with increased cancer risk were older age at SLE diagnosis and being male. The analyses also confirmed that older age was a risk factor for breast cancer (aHR 1.06; 95% CI, 1.02-1.10) and nonmelanoma skin cancer (aHR, 1.06; 95% CI, 1.02-1.11), while use of antimalarial drugs was associated with a lower risk of both breast (aHR, 0.28; 95% CI, 0.09-0.90) and nonmelanoma skin (aHR, 0.23; 95% CI, 0.05-0.95) cancers. For lung cancer, the highest risk factor was smoking 15 or more cigarettes a day (aHR, 6.64; 95% CI, 1.43-30.9); for hematologic cancers, it was being in the top quartile of SLE disease activity (aHR, 7.14; 95% CI, 1.13-45.3).

The authors acknowledged their study’s limitations, including the small number of cancers overall and purposefully not comparing cancer risk in SLE patients with risk in the general population. Although their methods – “physicians recording events at annual visits, confirmed by review of charts” – were recognized as very suitable for the current analysis, they noted that a broader comparison would “potentially be problematic due to differential misclassification error” in cancer registry data.

Two of the study’s authors reported potential conflicts of interest, including receiving grants and consulting and personal fees from various pharmaceutical companies. No other potential conflicts were reported.

SOURCE: Bernatsky S et al. Arthritis Care Res. 2020 Aug 19. doi: 10.1002/acr.24425.

A new study has quantified cancer risk factors in patients with systemic lupus erythematosus, including smoking and the use of certain medications.

“As expected, older age was associated with cancer overall, as well as with the most common cancer subtypes,” wrote Sasha Bernatsky, MD, PhD, of McGill University, Montreal, and coauthors. The study was published in Arthritis Care & Research.

To determine the risk of cancer in people with clinically confirmed incident systemic lupus erythematosus (SLE), the researchers analyzed data from 1,668 newly diagnosed lupus patients with at least one follow-up visit. All patients were enrolled in the Systemic Lupus International Collaborating Clinics inception cohort from across 33 different centers in North America, Europe, and Asia. A total of 89% (n = 1,480) were women, and 49% (n = 824) were white. The average follow-up period was 9 years.

Of the 1,668 SLE patients, 65 developed some type of cancer. The cancers included 15 breast;, 10 nonmelanoma skin; 7 lung; 6 hematologic, 6 prostate; 5 melanoma; 3 cervical; 3 renal; 2 gastric; 2 head and neck; 2 thyroid; and 1 rectal, sarcoma, thymoma, or uterine. No patient had more than one type, and the mean age of the cancer patients at time of SLE diagnosis was 45.6 (standard deviation, 14.5).



Almost half of the 65 cancers occurred in past or current smokers, including all of the lung cancers, while only 33% of patients without cancers smoked prior to baseline. After univariate analysis, characteristics associated with a higher risk of all cancers included older age at SLE diagnosis (adjusted hazard ratio, 1.05; 95% confidence interval, 1.03-1.06), White race/ethnicity (aHR 1.34; 95% CI, 0.76-2.37), and smoking (aHR 1.21; 95% CI, 0.73-2.01).

After multivariate analysis, the two characteristics most associated with increased cancer risk were older age at SLE diagnosis and being male. The analyses also confirmed that older age was a risk factor for breast cancer (aHR 1.06; 95% CI, 1.02-1.10) and nonmelanoma skin cancer (aHR, 1.06; 95% CI, 1.02-1.11), while use of antimalarial drugs was associated with a lower risk of both breast (aHR, 0.28; 95% CI, 0.09-0.90) and nonmelanoma skin (aHR, 0.23; 95% CI, 0.05-0.95) cancers. For lung cancer, the highest risk factor was smoking 15 or more cigarettes a day (aHR, 6.64; 95% CI, 1.43-30.9); for hematologic cancers, it was being in the top quartile of SLE disease activity (aHR, 7.14; 95% CI, 1.13-45.3).

The authors acknowledged their study’s limitations, including the small number of cancers overall and purposefully not comparing cancer risk in SLE patients with risk in the general population. Although their methods – “physicians recording events at annual visits, confirmed by review of charts” – were recognized as very suitable for the current analysis, they noted that a broader comparison would “potentially be problematic due to differential misclassification error” in cancer registry data.

Two of the study’s authors reported potential conflicts of interest, including receiving grants and consulting and personal fees from various pharmaceutical companies. No other potential conflicts were reported.

SOURCE: Bernatsky S et al. Arthritis Care Res. 2020 Aug 19. doi: 10.1002/acr.24425.

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COVID-19 plans put to test as firefighters crowd camps for peak wildfire season

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Thu, 08/26/2021 - 16:01

Jon Paul was leery entering his first wildfire camp of the year late last month to fight three lightning-caused fires scorching parts of a Northern California forest that hadn’t burned in 40 years.

Courtesy of U.S. Forest Service
Firefighters wear face masks at a morning briefing on the Bighorn Fire, north of Tucson, Ariz., on June 22, 2020. COVID-prevention protocols – based on guidelines from the Centers for Disease Control and Prevention – are recommended for wildfire camps.

The 54-year-old engine captain from southern Oregon knew from experience that these crowded, grimy camps can be breeding grounds for norovirus and a respiratory illness that firefighters call the “camp crud” in a normal year. He wondered what the coronavirus would do in the tent cities where hundreds of men and women eat, sleep, wash, and spend their downtime between shifts.

Mr. Paul thought about his immunocompromised wife and his 84-year-old mother back home. Then he joined the approximately 1,300 people spread across the Modoc National Forest who would provide a major test for the COVID-prevention measures that had been developed for wildland firefighters.

“We’re still first responders and we have that responsibility to go and deal with these emergencies,” he said in a recent interview. “I don’t scare easy, but I’m very wary and concerned about my surroundings. I’m still going to work and do my job.”

Mr. Paul is one of thousands of firefighters from across the United States battling dozens of wildfires burning throughout the West. It’s an inherently dangerous job that now carries the additional risk of COVID-19 transmission. Any outbreak that ripples through a camp could easily sideline crews and spread the virus across multiple fires – and back to communities across the country – as personnel transfer in and out of “hot zones” and return home.

Though most firefighters are young and fit, some will inevitably fall ill in these remote makeshift communities of shared showers and portable toilets, where medical care can be limited. The pollutants in the smoke they breathe daily also make them more susceptible to COVID-19 and can worsen the effects of the disease, according to the Centers for Disease Control and Prevention.

Also, one suspected or positive case in a camp will mean many other firefighters will need to be quarantined, unable to work. The worst-case scenario is that multiple outbreaks could hamstring the nation’s ability to respond as wildfire season peaks in August, the hottest and driest month of the year in the western United States.

The number of acres burned so far this year is below the 10-year average, but the fire outlook for August is above average in nine states, according to the National Interagency Fire Center. Twenty-two large fires were ignited on Monday alone after lightning storms passed through the Northwest.

A study published this month by researchers at Colorado State University and the U.S. Forest Service’s Rocky Mountain Research Station concluded that COVID outbreaks “could be a serious threat to the firefighting mission” and urged vigilant social distancing and screening measures in the camps.

“If simultaneous fires incurred outbreaks, the entire wildland response system could be stressed substantially, with a large portion of the workforce quarantined,” the study’s authors wrote.

This spring, the National Wildfire Coordinating Group’s Fire Management Board wrote – and has since been updating – protocols to prevent the spread of COVID-19 in fire camps, based on CDC guidelines. Though they can be adapted by managers at different fires and even by individual team, they center on some key recommendations, including the following:

  • Firefighters should be screened for fever and other COVID symptoms when they arrive at camp.
  • Every crew should insulate itself as a “module of one” for the fire season and limit interactions with other crews.
  • Firefighters should maintain social distancing and wear face coverings when social distancing isn’t possible. Smaller satellite camps, known as spike camps, can be built to ensure enough space.
  • Shared areas should be regularly cleaned and disinfected, and sharing tools and radios should be minimized.

The guidance does not include routine testing of newly arrived firefighters – a practice used for athletes at training camps and students returning to college campuses.

The Fire Management Board’s Wildland Fire Medical and Public Health Advisory Team wrote in a July 2 memo that it “does not recommend utilizing universal COVID-19 laboratory testing as a standalone risk mitigation or screening measure among wildland firefighters.” Rather, the group recommends testing an individual and directly exposed coworkers, saying that approach is in line with CDC guidance.

The lack of testing capacity and long turnaround times are factors, according to Forest Service spokesperson Dan Hottle.

The exception is Alaska, where firefighters are tested upon arrival at the airport and are quarantined in a hotel while awaiting results, which come within 24 hours, Mr. Hottle said.

Fire crews responding to early-season fires in the spring had some problems adjusting to the new protocols, according to assessments written by fire leaders and compiled by the Wildland Fire Lessons Learned Center.

Shawn Faiella, superintendent of the interagency “hotshot crew” – so named because they work the most challenging or “hottest” parts of wildfires – based at Montana’s Lolo National Forest, questioned the need to wear masks inside vehicles and the safety of bringing extra vehicles to space out firefighters traveling to a blaze. Parking extra vehicles at the scene of a fire is difficult in tight dirt roads – and would be dangerous if evacuations are necessary, he wrote.

“It’s damn tough to take these practices to the fire line,” Mr. Faiella wrote after his team responded to a 40-acre Montana fire in April.

One recommendation that fire managers say has been particularly effective is the “module of one” concept requiring crews to eat and sleep together in isolation for the entire fire season.

“Whoever came up with it, it is working,” said Mike Goicoechea, the Montana-based incident commander for the Forest Service’s Northern Region Type 1 team, which manages the nation’s largest and most complex wildfires and natural disasters. “Somebody may test positive, and you end up having to take that module out of service for 14 days. But the nice part is you’re not taking out a whole camp. ... It’s just that module.”

The total number of positive COVID cases among wildland firefighters among the various federal, state, local, and tribal agencies is not being tracked. Each fire agency has its own system for tracking and reporting COVID-19, said Jessica Gardetto, a spokesperson for the Bureau of Land Management (BLM) and the National Interagency Fire Center in Idaho.

The largest wildland firefighting agency is the Department of Agriculture’s Forest Service, with 10,000 firefighters. Another major agency is the Department of the Interior, which BLM is part of and which had more than 3,500 full-time fire employees last year. As of the first week of August, 111 Forest Service firefighters and 40 BLM firefighters (who work underneath the broader Interior Department agency) had tested positive for COVID-19, according to officials for the respective agencies.

“Considering we’ve now been experiencing fire activity for several months, this number is surprisingly low if you think about the thousands of fire personnel who’ve been suppressing wildfires this summer,” Ms. Gardetto said.

Mr. Goicoechea and his Montana team traveled north of Tucson, Arizona, on June 22 to manage a rapidly spreading fire in the Santa Catalina Mountains that required 1,200 responders at its peak. Within 2 days of the team’s arrival, his managers were overwhelmed by calls from firefighters worried or with questions about preventing the spread of COVID-19 or carrying the virus home to their families.

In an unusual move, Mr. Goicoechea called upon Montana physician – and former National Park Service ranger with wildfire experience – Harry Sibold, MD, to join the team. Physicians are rarely, if ever, part of a wildfire camp’s medical team, Mr. Goicoechea said.

Dr. Sibold gave regular coronavirus updates during morning briefings, consulted with local health officials, soothed firefighters worried about bringing the virus home to their families, and advised fire managers on how to handle scenarios that might come up.

But Dr. Sibold said he wasn’t optimistic at the beginning about keeping the coronavirus in check in a large camp in Pima County, which has the second-highest number of confirmed cases in Arizona, at the time a national COVID-19 hot spot. “I quite firmly expected that we might have two or three outbreaks,” he said.

There were no positive cases during the team’s 2-week deployment, just three or four cases in which a firefighter showed symptoms but tested negative for the virus. After the Montana team returned home, nine firefighters at the Arizona fire from other units tested positive, Mr. Goicoechea said. Contact tracers notified the Montana team, some of whom were tested. All tests returned negative.

“I can’t say enough about having that doctor to help,” Mr. Goicoechea said, suggesting other teams might consider doing the same. “We’re not the experts in a pandemic. We’re the experts with fire.”

That early success will be tested as the number of fires increases across the West, along with the number of firefighters responding to them. There were more than 15,000 firefighters and support personnel assigned to fires across the nation as of mid-August, and the success of those COVID-19 prevention protocols depend largely on them.

Mr. Paul, the Oregon firefighter, said that the guidelines were followed closely in camp, but less so out on the fire line. It also appeared to him that younger firefighters were less likely to follow the masking and social-distancing rules than the veterans like him. That worried him as he realized it wouldn’t take much to spark an outbreak that could sideline crews and cripple the ability to respond to a fire.

“We’re outside, so it definitely helps with mitigation and makes it simpler to social distance,” Mr. Paul said. “But I think if there’s a mistake made, it could happen.”

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.

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Jon Paul was leery entering his first wildfire camp of the year late last month to fight three lightning-caused fires scorching parts of a Northern California forest that hadn’t burned in 40 years.

Courtesy of U.S. Forest Service
Firefighters wear face masks at a morning briefing on the Bighorn Fire, north of Tucson, Ariz., on June 22, 2020. COVID-prevention protocols – based on guidelines from the Centers for Disease Control and Prevention – are recommended for wildfire camps.

The 54-year-old engine captain from southern Oregon knew from experience that these crowded, grimy camps can be breeding grounds for norovirus and a respiratory illness that firefighters call the “camp crud” in a normal year. He wondered what the coronavirus would do in the tent cities where hundreds of men and women eat, sleep, wash, and spend their downtime between shifts.

Mr. Paul thought about his immunocompromised wife and his 84-year-old mother back home. Then he joined the approximately 1,300 people spread across the Modoc National Forest who would provide a major test for the COVID-prevention measures that had been developed for wildland firefighters.

“We’re still first responders and we have that responsibility to go and deal with these emergencies,” he said in a recent interview. “I don’t scare easy, but I’m very wary and concerned about my surroundings. I’m still going to work and do my job.”

Mr. Paul is one of thousands of firefighters from across the United States battling dozens of wildfires burning throughout the West. It’s an inherently dangerous job that now carries the additional risk of COVID-19 transmission. Any outbreak that ripples through a camp could easily sideline crews and spread the virus across multiple fires – and back to communities across the country – as personnel transfer in and out of “hot zones” and return home.

Though most firefighters are young and fit, some will inevitably fall ill in these remote makeshift communities of shared showers and portable toilets, where medical care can be limited. The pollutants in the smoke they breathe daily also make them more susceptible to COVID-19 and can worsen the effects of the disease, according to the Centers for Disease Control and Prevention.

Also, one suspected or positive case in a camp will mean many other firefighters will need to be quarantined, unable to work. The worst-case scenario is that multiple outbreaks could hamstring the nation’s ability to respond as wildfire season peaks in August, the hottest and driest month of the year in the western United States.

The number of acres burned so far this year is below the 10-year average, but the fire outlook for August is above average in nine states, according to the National Interagency Fire Center. Twenty-two large fires were ignited on Monday alone after lightning storms passed through the Northwest.

A study published this month by researchers at Colorado State University and the U.S. Forest Service’s Rocky Mountain Research Station concluded that COVID outbreaks “could be a serious threat to the firefighting mission” and urged vigilant social distancing and screening measures in the camps.

“If simultaneous fires incurred outbreaks, the entire wildland response system could be stressed substantially, with a large portion of the workforce quarantined,” the study’s authors wrote.

This spring, the National Wildfire Coordinating Group’s Fire Management Board wrote – and has since been updating – protocols to prevent the spread of COVID-19 in fire camps, based on CDC guidelines. Though they can be adapted by managers at different fires and even by individual team, they center on some key recommendations, including the following:

  • Firefighters should be screened for fever and other COVID symptoms when they arrive at camp.
  • Every crew should insulate itself as a “module of one” for the fire season and limit interactions with other crews.
  • Firefighters should maintain social distancing and wear face coverings when social distancing isn’t possible. Smaller satellite camps, known as spike camps, can be built to ensure enough space.
  • Shared areas should be regularly cleaned and disinfected, and sharing tools and radios should be minimized.

The guidance does not include routine testing of newly arrived firefighters – a practice used for athletes at training camps and students returning to college campuses.

The Fire Management Board’s Wildland Fire Medical and Public Health Advisory Team wrote in a July 2 memo that it “does not recommend utilizing universal COVID-19 laboratory testing as a standalone risk mitigation or screening measure among wildland firefighters.” Rather, the group recommends testing an individual and directly exposed coworkers, saying that approach is in line with CDC guidance.

The lack of testing capacity and long turnaround times are factors, according to Forest Service spokesperson Dan Hottle.

The exception is Alaska, where firefighters are tested upon arrival at the airport and are quarantined in a hotel while awaiting results, which come within 24 hours, Mr. Hottle said.

Fire crews responding to early-season fires in the spring had some problems adjusting to the new protocols, according to assessments written by fire leaders and compiled by the Wildland Fire Lessons Learned Center.

Shawn Faiella, superintendent of the interagency “hotshot crew” – so named because they work the most challenging or “hottest” parts of wildfires – based at Montana’s Lolo National Forest, questioned the need to wear masks inside vehicles and the safety of bringing extra vehicles to space out firefighters traveling to a blaze. Parking extra vehicles at the scene of a fire is difficult in tight dirt roads – and would be dangerous if evacuations are necessary, he wrote.

“It’s damn tough to take these practices to the fire line,” Mr. Faiella wrote after his team responded to a 40-acre Montana fire in April.

One recommendation that fire managers say has been particularly effective is the “module of one” concept requiring crews to eat and sleep together in isolation for the entire fire season.

“Whoever came up with it, it is working,” said Mike Goicoechea, the Montana-based incident commander for the Forest Service’s Northern Region Type 1 team, which manages the nation’s largest and most complex wildfires and natural disasters. “Somebody may test positive, and you end up having to take that module out of service for 14 days. But the nice part is you’re not taking out a whole camp. ... It’s just that module.”

The total number of positive COVID cases among wildland firefighters among the various federal, state, local, and tribal agencies is not being tracked. Each fire agency has its own system for tracking and reporting COVID-19, said Jessica Gardetto, a spokesperson for the Bureau of Land Management (BLM) and the National Interagency Fire Center in Idaho.

The largest wildland firefighting agency is the Department of Agriculture’s Forest Service, with 10,000 firefighters. Another major agency is the Department of the Interior, which BLM is part of and which had more than 3,500 full-time fire employees last year. As of the first week of August, 111 Forest Service firefighters and 40 BLM firefighters (who work underneath the broader Interior Department agency) had tested positive for COVID-19, according to officials for the respective agencies.

“Considering we’ve now been experiencing fire activity for several months, this number is surprisingly low if you think about the thousands of fire personnel who’ve been suppressing wildfires this summer,” Ms. Gardetto said.

Mr. Goicoechea and his Montana team traveled north of Tucson, Arizona, on June 22 to manage a rapidly spreading fire in the Santa Catalina Mountains that required 1,200 responders at its peak. Within 2 days of the team’s arrival, his managers were overwhelmed by calls from firefighters worried or with questions about preventing the spread of COVID-19 or carrying the virus home to their families.

In an unusual move, Mr. Goicoechea called upon Montana physician – and former National Park Service ranger with wildfire experience – Harry Sibold, MD, to join the team. Physicians are rarely, if ever, part of a wildfire camp’s medical team, Mr. Goicoechea said.

Dr. Sibold gave regular coronavirus updates during morning briefings, consulted with local health officials, soothed firefighters worried about bringing the virus home to their families, and advised fire managers on how to handle scenarios that might come up.

But Dr. Sibold said he wasn’t optimistic at the beginning about keeping the coronavirus in check in a large camp in Pima County, which has the second-highest number of confirmed cases in Arizona, at the time a national COVID-19 hot spot. “I quite firmly expected that we might have two or three outbreaks,” he said.

There were no positive cases during the team’s 2-week deployment, just three or four cases in which a firefighter showed symptoms but tested negative for the virus. After the Montana team returned home, nine firefighters at the Arizona fire from other units tested positive, Mr. Goicoechea said. Contact tracers notified the Montana team, some of whom were tested. All tests returned negative.

“I can’t say enough about having that doctor to help,” Mr. Goicoechea said, suggesting other teams might consider doing the same. “We’re not the experts in a pandemic. We’re the experts with fire.”

That early success will be tested as the number of fires increases across the West, along with the number of firefighters responding to them. There were more than 15,000 firefighters and support personnel assigned to fires across the nation as of mid-August, and the success of those COVID-19 prevention protocols depend largely on them.

Mr. Paul, the Oregon firefighter, said that the guidelines were followed closely in camp, but less so out on the fire line. It also appeared to him that younger firefighters were less likely to follow the masking and social-distancing rules than the veterans like him. That worried him as he realized it wouldn’t take much to spark an outbreak that could sideline crews and cripple the ability to respond to a fire.

“We’re outside, so it definitely helps with mitigation and makes it simpler to social distance,” Mr. Paul said. “But I think if there’s a mistake made, it could happen.”

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.

Jon Paul was leery entering his first wildfire camp of the year late last month to fight three lightning-caused fires scorching parts of a Northern California forest that hadn’t burned in 40 years.

Courtesy of U.S. Forest Service
Firefighters wear face masks at a morning briefing on the Bighorn Fire, north of Tucson, Ariz., on June 22, 2020. COVID-prevention protocols – based on guidelines from the Centers for Disease Control and Prevention – are recommended for wildfire camps.

The 54-year-old engine captain from southern Oregon knew from experience that these crowded, grimy camps can be breeding grounds for norovirus and a respiratory illness that firefighters call the “camp crud” in a normal year. He wondered what the coronavirus would do in the tent cities where hundreds of men and women eat, sleep, wash, and spend their downtime between shifts.

Mr. Paul thought about his immunocompromised wife and his 84-year-old mother back home. Then he joined the approximately 1,300 people spread across the Modoc National Forest who would provide a major test for the COVID-prevention measures that had been developed for wildland firefighters.

“We’re still first responders and we have that responsibility to go and deal with these emergencies,” he said in a recent interview. “I don’t scare easy, but I’m very wary and concerned about my surroundings. I’m still going to work and do my job.”

Mr. Paul is one of thousands of firefighters from across the United States battling dozens of wildfires burning throughout the West. It’s an inherently dangerous job that now carries the additional risk of COVID-19 transmission. Any outbreak that ripples through a camp could easily sideline crews and spread the virus across multiple fires – and back to communities across the country – as personnel transfer in and out of “hot zones” and return home.

Though most firefighters are young and fit, some will inevitably fall ill in these remote makeshift communities of shared showers and portable toilets, where medical care can be limited. The pollutants in the smoke they breathe daily also make them more susceptible to COVID-19 and can worsen the effects of the disease, according to the Centers for Disease Control and Prevention.

Also, one suspected or positive case in a camp will mean many other firefighters will need to be quarantined, unable to work. The worst-case scenario is that multiple outbreaks could hamstring the nation’s ability to respond as wildfire season peaks in August, the hottest and driest month of the year in the western United States.

The number of acres burned so far this year is below the 10-year average, but the fire outlook for August is above average in nine states, according to the National Interagency Fire Center. Twenty-two large fires were ignited on Monday alone after lightning storms passed through the Northwest.

A study published this month by researchers at Colorado State University and the U.S. Forest Service’s Rocky Mountain Research Station concluded that COVID outbreaks “could be a serious threat to the firefighting mission” and urged vigilant social distancing and screening measures in the camps.

“If simultaneous fires incurred outbreaks, the entire wildland response system could be stressed substantially, with a large portion of the workforce quarantined,” the study’s authors wrote.

This spring, the National Wildfire Coordinating Group’s Fire Management Board wrote – and has since been updating – protocols to prevent the spread of COVID-19 in fire camps, based on CDC guidelines. Though they can be adapted by managers at different fires and even by individual team, they center on some key recommendations, including the following:

  • Firefighters should be screened for fever and other COVID symptoms when they arrive at camp.
  • Every crew should insulate itself as a “module of one” for the fire season and limit interactions with other crews.
  • Firefighters should maintain social distancing and wear face coverings when social distancing isn’t possible. Smaller satellite camps, known as spike camps, can be built to ensure enough space.
  • Shared areas should be regularly cleaned and disinfected, and sharing tools and radios should be minimized.

The guidance does not include routine testing of newly arrived firefighters – a practice used for athletes at training camps and students returning to college campuses.

The Fire Management Board’s Wildland Fire Medical and Public Health Advisory Team wrote in a July 2 memo that it “does not recommend utilizing universal COVID-19 laboratory testing as a standalone risk mitigation or screening measure among wildland firefighters.” Rather, the group recommends testing an individual and directly exposed coworkers, saying that approach is in line with CDC guidance.

The lack of testing capacity and long turnaround times are factors, according to Forest Service spokesperson Dan Hottle.

The exception is Alaska, where firefighters are tested upon arrival at the airport and are quarantined in a hotel while awaiting results, which come within 24 hours, Mr. Hottle said.

Fire crews responding to early-season fires in the spring had some problems adjusting to the new protocols, according to assessments written by fire leaders and compiled by the Wildland Fire Lessons Learned Center.

Shawn Faiella, superintendent of the interagency “hotshot crew” – so named because they work the most challenging or “hottest” parts of wildfires – based at Montana’s Lolo National Forest, questioned the need to wear masks inside vehicles and the safety of bringing extra vehicles to space out firefighters traveling to a blaze. Parking extra vehicles at the scene of a fire is difficult in tight dirt roads – and would be dangerous if evacuations are necessary, he wrote.

“It’s damn tough to take these practices to the fire line,” Mr. Faiella wrote after his team responded to a 40-acre Montana fire in April.

One recommendation that fire managers say has been particularly effective is the “module of one” concept requiring crews to eat and sleep together in isolation for the entire fire season.

“Whoever came up with it, it is working,” said Mike Goicoechea, the Montana-based incident commander for the Forest Service’s Northern Region Type 1 team, which manages the nation’s largest and most complex wildfires and natural disasters. “Somebody may test positive, and you end up having to take that module out of service for 14 days. But the nice part is you’re not taking out a whole camp. ... It’s just that module.”

The total number of positive COVID cases among wildland firefighters among the various federal, state, local, and tribal agencies is not being tracked. Each fire agency has its own system for tracking and reporting COVID-19, said Jessica Gardetto, a spokesperson for the Bureau of Land Management (BLM) and the National Interagency Fire Center in Idaho.

The largest wildland firefighting agency is the Department of Agriculture’s Forest Service, with 10,000 firefighters. Another major agency is the Department of the Interior, which BLM is part of and which had more than 3,500 full-time fire employees last year. As of the first week of August, 111 Forest Service firefighters and 40 BLM firefighters (who work underneath the broader Interior Department agency) had tested positive for COVID-19, according to officials for the respective agencies.

“Considering we’ve now been experiencing fire activity for several months, this number is surprisingly low if you think about the thousands of fire personnel who’ve been suppressing wildfires this summer,” Ms. Gardetto said.

Mr. Goicoechea and his Montana team traveled north of Tucson, Arizona, on June 22 to manage a rapidly spreading fire in the Santa Catalina Mountains that required 1,200 responders at its peak. Within 2 days of the team’s arrival, his managers were overwhelmed by calls from firefighters worried or with questions about preventing the spread of COVID-19 or carrying the virus home to their families.

In an unusual move, Mr. Goicoechea called upon Montana physician – and former National Park Service ranger with wildfire experience – Harry Sibold, MD, to join the team. Physicians are rarely, if ever, part of a wildfire camp’s medical team, Mr. Goicoechea said.

Dr. Sibold gave regular coronavirus updates during morning briefings, consulted with local health officials, soothed firefighters worried about bringing the virus home to their families, and advised fire managers on how to handle scenarios that might come up.

But Dr. Sibold said he wasn’t optimistic at the beginning about keeping the coronavirus in check in a large camp in Pima County, which has the second-highest number of confirmed cases in Arizona, at the time a national COVID-19 hot spot. “I quite firmly expected that we might have two or three outbreaks,” he said.

There were no positive cases during the team’s 2-week deployment, just three or four cases in which a firefighter showed symptoms but tested negative for the virus. After the Montana team returned home, nine firefighters at the Arizona fire from other units tested positive, Mr. Goicoechea said. Contact tracers notified the Montana team, some of whom were tested. All tests returned negative.

“I can’t say enough about having that doctor to help,” Mr. Goicoechea said, suggesting other teams might consider doing the same. “We’re not the experts in a pandemic. We’re the experts with fire.”

That early success will be tested as the number of fires increases across the West, along with the number of firefighters responding to them. There were more than 15,000 firefighters and support personnel assigned to fires across the nation as of mid-August, and the success of those COVID-19 prevention protocols depend largely on them.

Mr. Paul, the Oregon firefighter, said that the guidelines were followed closely in camp, but less so out on the fire line. It also appeared to him that younger firefighters were less likely to follow the masking and social-distancing rules than the veterans like him. That worried him as he realized it wouldn’t take much to spark an outbreak that could sideline crews and cripple the ability to respond to a fire.

“We’re outside, so it definitely helps with mitigation and makes it simpler to social distance,” Mr. Paul said. “But I think if there’s a mistake made, it could happen.”

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.

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Hospitalists confront administrative, financial challenges of COVID-19 crisis

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Thu, 08/26/2021 - 16:01

Hospitalists nationwide have put in longer hours, played new clinical roles, and stretched beyond their medical specialty and comfort level to meet their hospital’s COVID-19 care demands. Can they expect some kind of financial recognition – perhaps in the form of “hazard pay” for going above and beyond – even though their institutions are experiencing negative financial fallout from the crisis?

Dr. Ron Greeno

Hospitals in regions experiencing a COVID-19 surge have limited elective procedures, discouraged non–COVID-19 admissions, and essentially entered crisis management mode. Other facilities in less hard-hit communities are also standing by, with reduced hospital census, smaller caseloads and less work to do, while trying to prepare their bottom lines for lower demand.

“This crisis has put most hospitals in financial jeopardy and that is likely to trickle down to all employees – including hospitalists,” said Ron Greeno, MD, FCCP, MHM, a past president of SHM and the society’s current senior advisor for government affairs. “But it’s not like hospitals could or would forgo an effective hospitalist program today. Hospitalists will be important players in defining the hospital’s future direction post crisis.”

That doesn’t mean tighter financials, caps on annual salary increases, or higher productivity expectations won’t be part of future conversations between hospital administrators and their hospitalists, Dr. Greeno said. Administrators are starting to look ahead to the post–COVID-19 era even as numbers of cases and rates of growth continue to rise in various regions, and Dr. Greeno sees a lot of uncertainty ahead.

Even prior to the crisis, he noted, hospital margins had been falling, while the cost of labor, including hospitalist labor, was going up. That was pointing toward an inevitable collision, which has only intensified with the new financial crisis facing hospitals – created by SARS-CoV-2 and by policies such as shutting down elective surgeries in anticipation of a COVID-19 patient surge that, for some institutions, may never come.

Dr. Brian Harte

Brian Harte, MD, MHM, president of Cleveland Clinic Akron General and a past president of SHM, said that the Cleveland Clinic system has been planning since January its response to the coming crisis. “Governor Mike DeWine and the state Department of Health led the way in flattening the curve in Ohio. We engaged our hospitalists in brainstorming solutions. They have been excellent partners,” he said.

Approaching the crisis with a sense of urgency from the outset, the Cleveland Clinic built a COVID-19 surge team and incident command structure, with nursing, infectious diseases, critical care and hospital medicine represented. “We used that time to get ready for what was coming. We worked on streamlining consultant work flows.”

But utilization numbers are off in almost every service line, Dr. Harte said. “It has forced us to look at things we’ve always talked about, including greater use of telemedicine and exploring other ways of caring for patients, such as increased use of evening hours.”

Cleveland Clinic contracts with Sound Physicians of Tacoma, Wash., for its hospitalist coverage. “We have an excellent working relationship with Sound at the local, regional, and national levels, with common goals for quality and utilization. We tried to involve our hospitalists as early as possible in planning. We needed them to step in and role model and lead the way,” Dr. Harte said, for everybody’s anxiety levels.

“We’re still in the process of understanding the long-term financial impact of the epidemic,” Dr. Harte added. “But at this point I see no reason to think our relationship with our hospitalists needs to change. We’re the stewards of long-term finances. We’ll need to keep a close eye on this. But we’re committed to working through this together.”

Hazard pay for frontline health care workers was included in the COVID-19 relief package assembled in mid-May by Democrats in the House of Representatives. The $3 trillion HEROES Act includes $200 billion to award hazard pay to essential workers, including those in the health field, but Senate Majority Leader Mitch McConnell (R-Ky.) declared the legislation “dead on arrival” in the Senate.

Supplementary hazard payments made by hospitals to their hospitalists as a reward for sacrifices they made in the crisis is an interesting question, Dr. Greeno noted, and it’s definitely on the table at some hospitals. “But I think it is going to be a tough ask in these times.”

Dr. Harte said he has not offered nor been asked about hazard pay for hospitalists. Cleveland Clinic Akron General made a strategic decision that hazard pay was not going to be part of its response to the pandemic. Other hospital administrators interviewed for this article concur.

 

 

Hospitals respond to the fiscal crisis

Hospitals in other parts of the country also report significant fiscal fallout from the COVID-19 crisis, with predictions that 100 or more hospitals may be forced to close. Jeff Dye, president of the New Mexico Hospital Association, told the Albuquerque Journal on May 1 that hospitals in his state have been squeezed on all sides by increased costs, patients delaying routine care, and public health orders restricting elective surgeries. New Mexico hospitals, especially in rural areas, face incredible financial strain.

The University of Virginia Medical Center, Charlottesville, recently announced 20% reductions in total compensation for its providers through July 31, along with suspension of retirement contributions. Those changes won’t affect team members caring for COVID-19 patients. And the Spectrum Health Medical Group of 15 hospitals in western Michigan, according to Michigan Public Radio, told its doctors they either needed to sign “contract addendums” giving the system more control over their hours – or face a 25% pay cut, or worse.

Cheyenne (Wyo.) Regional Medical Center issued a statement April 24 that it expected losses of $10 million for the month of April. “CRMC, like every other hospital in Wyoming, is certainly feeling the financial impact that COVID-19 is having,” CEO Tim Thornell told the Cowboy State Daily on April 24. That includes a 30% reduction in inpatient care and 50% reduction in outpatient care, while the hospital has only had a handful of COVID-19 patients at any time. Capital projects are now on hold, overtime is limited, and a hiring freeze is in effect.

“We’re certainly prepared for a larger surge, which hasn’t come yet,” Mr. Thornell said in an interview. CRMC’s ICU was split to create a nine-bed dedicated COVID-19 unit. Intensivists see most of the critical care patients, while the hospital’s 15 directly-employed hospitalists are treating all of the non-ICU COVID-19 patients. “Among themselves, the hospitalists volunteered who would work on the unit. We’ve been fortunate enough to have enough volunteers and enough PPE [personal protective equipment],” he said.

Preparing for the COVID-19 pandemic has strengthened the medical center’s relationship with its hospitalists, Mr. Thornell explained. “Hospitalists are key to our operations, involved in so much that happens here. We’re trying to staff to volume with decreased utilization. We’ve scaled back, which only makes fiscal sense. Now, how do we reinfuse patients back into the mix? Our hospitalists are paid by the number of shifts, and as you distribute shift reductions over 15 providers, it shouldn’t be an intolerable burden.” But two open hospitalist positions have not been filled, he noted.

CRMC is trying to approach these changes with a Lean perspective, Mr. Thornell said. “We had already adopted a Lean program, but this has been a chance to go through a life-altering circumstance using the tools of Lean planning and applying them instantaneously.”
 

Providers step up

At Emory Healthcare in Atlanta, a major center for COVID-19 cases, communication has been essential in the crisis, said Bryce Gartland, MD, SFHM, Emory’s hospital group president and cochief of clinical operations. “Our group was prepared for a significant influx of patients. Like every other institution, we made the decision to postpone elective care, with a resulting plummet in volume,” he said.

Dr. Bryce Gartland

As COVID-19 patients entered the Emory system, frontline hospitalists stepped up to care for those patients. “We’ve had ample providers in terms of clinical care. We guaranteed our physicians’ base compensation. They have flexed teams up and down as needed.” Advanced practice professionals also stepped up to bridge gaps.

With regard to the return of volumes of non–COVID-19 patients, the jury’s still out, Dr. Gartland said. “None of us has a crystal ball, and there are tremendous variables and decision points that will have significant impact. We have started to see numbers of time-sensitive and essential cases increase as of the first week of May.”

What lies ahead will likely include some rightsizing to future volumes. On top of that, the broader economic pressures on hospitals from high rates of unemployment, uninsured patients, bad debt, and charity care will push health care systems to significantly address costs and infrastructure, he said. “We’re still early in planning, and striving to maintain flexibility and nimbleness, given the uncertainties to this early understanding of our new normal. No hospital is immune from the financial impact. We’ll see and hear about more of these conversations in the months ahead.”

But the experience has also generated some positives, Dr. Gartland noted. “Things like telehealth, which we’ve been talking about for years but previously faced barriers to widespread adoption.” Now with COVID-19, the federal government issued waivers, and barriers – both internal and external – came down. “With telehealth, what will the role and deployment of hospitalists look like in this new model? How will traditional productivity expectations change, or the numbers and types of providers? This will make the relationship and partnership between hospitalist groups and hospital administrators ever more important as we consider the evolution toward new care models.”

Dr. Gartland said that “one of the great things about hospital medicine as a field is its flexibility and adaptability. Where there have been gaps, hospitalists were quick to step in. As long as hospital medicine continues to embrace those kinds of behaviors, it will be successful.” But if the conversation with hospitals is just about money, it will be harder, he acknowledged. “Where there is this kind of disruption in our usual way of doing things, there are also tremendous opportunities for care model innovation. I would encourage hospitalist groups to try to be true value partners.”

Command center mode

Like other physicians in hospital C-suites, Chad Whelan MD, FACP, SFHM, chief executive officer of Banner–University Medicine in Tucson, Ariz., led his two hospitals into command center mode when the crisis hit, planning for a surge of COVID-19 cases that could overwhelm hospital capacity.

Dr. Chad T. Whelan

“In terms of our hospitalists, we leaned in to them hard in the beginning, preparing them to supervise other physicians who came in to help if needed,” he said. “Our [non–COVID-19] census is down, revenues are down, and the implications are enormous – like nothing we’ve ever seen before.”

“We’re fortunate that we’re part of the Banner health system. We made a decision that we would essentially keep our physicians financially protected through this crisis,” Dr. Whelan said. “In return, we called on them to step up and be on the front lines and to put in enormous hours for planning. We asked them to consider: How could you contribute if the surge comes?”

He affirmed that hospital medicine has been a major part of his medical center’s planning and implementation. “I’ve been overwhelmed by the degree to which the entire delivery team has rallied around the pandemic, with everybody saying they want to keep people safe and be part of the solution. We have always had hospitalist leaders at the table as we’ve planned our response and as decisions were made,” said Dr. Whelan, a practicing hospitalist and teaching service attending since 2000 until he assumed his current executive position in Arizona 18 months ago.

“While we have kept people whole during the immediate crisis, we have acknowledged that we don’t know what our recovery will look like. What if [non–COVID-19] volume doesn’t return? That keeps me awake at night,” he said. “I have talked to our physician leadership in hospital medicine and more broadly. We need to ask ourselves many questions, including: do we have the right levels of staffing? Is this the time to consider alternate models of staffing, for example, advanced practice providers? And does the compensation plan need adjustments?”

Dr. Whelan thinks that the COVID-19 crisis is an opportunity for hospital medicine to more rapidly explore different models and to ask what additional value hospitalists can bring to the care model. “For example, what would it mean to redefine the hospitalist’s scope of practice as an acute medicine specialist, not defined by the hospital’s four walls?” he noted.

“One of the reasons our smaller hospital reached capacity with COVID-19 patients was the skilled nursing facility located a few hundred feet away that turned into a hot spot. If we had imported the hospital medicine model virtually into that SNF early on, could there have been a different scenario? Have we thought through what that would have even looked like?” Dr. Whelan asked.

He challenges the hospital medicine field, once it gets to the other side of this crisis, to not fall back on old way of doing things. “Instead, let’s use this time to create a better model today,” he said. “That’s what we’re trying to do at a system level at Banner, with our hospital medicine groups partnering with the hospital. I want to see our hospitalists create and thrive in that new model.”

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Hospitalists nationwide have put in longer hours, played new clinical roles, and stretched beyond their medical specialty and comfort level to meet their hospital’s COVID-19 care demands. Can they expect some kind of financial recognition – perhaps in the form of “hazard pay” for going above and beyond – even though their institutions are experiencing negative financial fallout from the crisis?

Dr. Ron Greeno

Hospitals in regions experiencing a COVID-19 surge have limited elective procedures, discouraged non–COVID-19 admissions, and essentially entered crisis management mode. Other facilities in less hard-hit communities are also standing by, with reduced hospital census, smaller caseloads and less work to do, while trying to prepare their bottom lines for lower demand.

“This crisis has put most hospitals in financial jeopardy and that is likely to trickle down to all employees – including hospitalists,” said Ron Greeno, MD, FCCP, MHM, a past president of SHM and the society’s current senior advisor for government affairs. “But it’s not like hospitals could or would forgo an effective hospitalist program today. Hospitalists will be important players in defining the hospital’s future direction post crisis.”

That doesn’t mean tighter financials, caps on annual salary increases, or higher productivity expectations won’t be part of future conversations between hospital administrators and their hospitalists, Dr. Greeno said. Administrators are starting to look ahead to the post–COVID-19 era even as numbers of cases and rates of growth continue to rise in various regions, and Dr. Greeno sees a lot of uncertainty ahead.

Even prior to the crisis, he noted, hospital margins had been falling, while the cost of labor, including hospitalist labor, was going up. That was pointing toward an inevitable collision, which has only intensified with the new financial crisis facing hospitals – created by SARS-CoV-2 and by policies such as shutting down elective surgeries in anticipation of a COVID-19 patient surge that, for some institutions, may never come.

Dr. Brian Harte

Brian Harte, MD, MHM, president of Cleveland Clinic Akron General and a past president of SHM, said that the Cleveland Clinic system has been planning since January its response to the coming crisis. “Governor Mike DeWine and the state Department of Health led the way in flattening the curve in Ohio. We engaged our hospitalists in brainstorming solutions. They have been excellent partners,” he said.

Approaching the crisis with a sense of urgency from the outset, the Cleveland Clinic built a COVID-19 surge team and incident command structure, with nursing, infectious diseases, critical care and hospital medicine represented. “We used that time to get ready for what was coming. We worked on streamlining consultant work flows.”

But utilization numbers are off in almost every service line, Dr. Harte said. “It has forced us to look at things we’ve always talked about, including greater use of telemedicine and exploring other ways of caring for patients, such as increased use of evening hours.”

Cleveland Clinic contracts with Sound Physicians of Tacoma, Wash., for its hospitalist coverage. “We have an excellent working relationship with Sound at the local, regional, and national levels, with common goals for quality and utilization. We tried to involve our hospitalists as early as possible in planning. We needed them to step in and role model and lead the way,” Dr. Harte said, for everybody’s anxiety levels.

“We’re still in the process of understanding the long-term financial impact of the epidemic,” Dr. Harte added. “But at this point I see no reason to think our relationship with our hospitalists needs to change. We’re the stewards of long-term finances. We’ll need to keep a close eye on this. But we’re committed to working through this together.”

Hazard pay for frontline health care workers was included in the COVID-19 relief package assembled in mid-May by Democrats in the House of Representatives. The $3 trillion HEROES Act includes $200 billion to award hazard pay to essential workers, including those in the health field, but Senate Majority Leader Mitch McConnell (R-Ky.) declared the legislation “dead on arrival” in the Senate.

Supplementary hazard payments made by hospitals to their hospitalists as a reward for sacrifices they made in the crisis is an interesting question, Dr. Greeno noted, and it’s definitely on the table at some hospitals. “But I think it is going to be a tough ask in these times.”

Dr. Harte said he has not offered nor been asked about hazard pay for hospitalists. Cleveland Clinic Akron General made a strategic decision that hazard pay was not going to be part of its response to the pandemic. Other hospital administrators interviewed for this article concur.

 

 

Hospitals respond to the fiscal crisis

Hospitals in other parts of the country also report significant fiscal fallout from the COVID-19 crisis, with predictions that 100 or more hospitals may be forced to close. Jeff Dye, president of the New Mexico Hospital Association, told the Albuquerque Journal on May 1 that hospitals in his state have been squeezed on all sides by increased costs, patients delaying routine care, and public health orders restricting elective surgeries. New Mexico hospitals, especially in rural areas, face incredible financial strain.

The University of Virginia Medical Center, Charlottesville, recently announced 20% reductions in total compensation for its providers through July 31, along with suspension of retirement contributions. Those changes won’t affect team members caring for COVID-19 patients. And the Spectrum Health Medical Group of 15 hospitals in western Michigan, according to Michigan Public Radio, told its doctors they either needed to sign “contract addendums” giving the system more control over their hours – or face a 25% pay cut, or worse.

Cheyenne (Wyo.) Regional Medical Center issued a statement April 24 that it expected losses of $10 million for the month of April. “CRMC, like every other hospital in Wyoming, is certainly feeling the financial impact that COVID-19 is having,” CEO Tim Thornell told the Cowboy State Daily on April 24. That includes a 30% reduction in inpatient care and 50% reduction in outpatient care, while the hospital has only had a handful of COVID-19 patients at any time. Capital projects are now on hold, overtime is limited, and a hiring freeze is in effect.

“We’re certainly prepared for a larger surge, which hasn’t come yet,” Mr. Thornell said in an interview. CRMC’s ICU was split to create a nine-bed dedicated COVID-19 unit. Intensivists see most of the critical care patients, while the hospital’s 15 directly-employed hospitalists are treating all of the non-ICU COVID-19 patients. “Among themselves, the hospitalists volunteered who would work on the unit. We’ve been fortunate enough to have enough volunteers and enough PPE [personal protective equipment],” he said.

Preparing for the COVID-19 pandemic has strengthened the medical center’s relationship with its hospitalists, Mr. Thornell explained. “Hospitalists are key to our operations, involved in so much that happens here. We’re trying to staff to volume with decreased utilization. We’ve scaled back, which only makes fiscal sense. Now, how do we reinfuse patients back into the mix? Our hospitalists are paid by the number of shifts, and as you distribute shift reductions over 15 providers, it shouldn’t be an intolerable burden.” But two open hospitalist positions have not been filled, he noted.

CRMC is trying to approach these changes with a Lean perspective, Mr. Thornell said. “We had already adopted a Lean program, but this has been a chance to go through a life-altering circumstance using the tools of Lean planning and applying them instantaneously.”
 

Providers step up

At Emory Healthcare in Atlanta, a major center for COVID-19 cases, communication has been essential in the crisis, said Bryce Gartland, MD, SFHM, Emory’s hospital group president and cochief of clinical operations. “Our group was prepared for a significant influx of patients. Like every other institution, we made the decision to postpone elective care, with a resulting plummet in volume,” he said.

Dr. Bryce Gartland

As COVID-19 patients entered the Emory system, frontline hospitalists stepped up to care for those patients. “We’ve had ample providers in terms of clinical care. We guaranteed our physicians’ base compensation. They have flexed teams up and down as needed.” Advanced practice professionals also stepped up to bridge gaps.

With regard to the return of volumes of non–COVID-19 patients, the jury’s still out, Dr. Gartland said. “None of us has a crystal ball, and there are tremendous variables and decision points that will have significant impact. We have started to see numbers of time-sensitive and essential cases increase as of the first week of May.”

What lies ahead will likely include some rightsizing to future volumes. On top of that, the broader economic pressures on hospitals from high rates of unemployment, uninsured patients, bad debt, and charity care will push health care systems to significantly address costs and infrastructure, he said. “We’re still early in planning, and striving to maintain flexibility and nimbleness, given the uncertainties to this early understanding of our new normal. No hospital is immune from the financial impact. We’ll see and hear about more of these conversations in the months ahead.”

But the experience has also generated some positives, Dr. Gartland noted. “Things like telehealth, which we’ve been talking about for years but previously faced barriers to widespread adoption.” Now with COVID-19, the federal government issued waivers, and barriers – both internal and external – came down. “With telehealth, what will the role and deployment of hospitalists look like in this new model? How will traditional productivity expectations change, or the numbers and types of providers? This will make the relationship and partnership between hospitalist groups and hospital administrators ever more important as we consider the evolution toward new care models.”

Dr. Gartland said that “one of the great things about hospital medicine as a field is its flexibility and adaptability. Where there have been gaps, hospitalists were quick to step in. As long as hospital medicine continues to embrace those kinds of behaviors, it will be successful.” But if the conversation with hospitals is just about money, it will be harder, he acknowledged. “Where there is this kind of disruption in our usual way of doing things, there are also tremendous opportunities for care model innovation. I would encourage hospitalist groups to try to be true value partners.”

Command center mode

Like other physicians in hospital C-suites, Chad Whelan MD, FACP, SFHM, chief executive officer of Banner–University Medicine in Tucson, Ariz., led his two hospitals into command center mode when the crisis hit, planning for a surge of COVID-19 cases that could overwhelm hospital capacity.

Dr. Chad T. Whelan

“In terms of our hospitalists, we leaned in to them hard in the beginning, preparing them to supervise other physicians who came in to help if needed,” he said. “Our [non–COVID-19] census is down, revenues are down, and the implications are enormous – like nothing we’ve ever seen before.”

“We’re fortunate that we’re part of the Banner health system. We made a decision that we would essentially keep our physicians financially protected through this crisis,” Dr. Whelan said. “In return, we called on them to step up and be on the front lines and to put in enormous hours for planning. We asked them to consider: How could you contribute if the surge comes?”

He affirmed that hospital medicine has been a major part of his medical center’s planning and implementation. “I’ve been overwhelmed by the degree to which the entire delivery team has rallied around the pandemic, with everybody saying they want to keep people safe and be part of the solution. We have always had hospitalist leaders at the table as we’ve planned our response and as decisions were made,” said Dr. Whelan, a practicing hospitalist and teaching service attending since 2000 until he assumed his current executive position in Arizona 18 months ago.

“While we have kept people whole during the immediate crisis, we have acknowledged that we don’t know what our recovery will look like. What if [non–COVID-19] volume doesn’t return? That keeps me awake at night,” he said. “I have talked to our physician leadership in hospital medicine and more broadly. We need to ask ourselves many questions, including: do we have the right levels of staffing? Is this the time to consider alternate models of staffing, for example, advanced practice providers? And does the compensation plan need adjustments?”

Dr. Whelan thinks that the COVID-19 crisis is an opportunity for hospital medicine to more rapidly explore different models and to ask what additional value hospitalists can bring to the care model. “For example, what would it mean to redefine the hospitalist’s scope of practice as an acute medicine specialist, not defined by the hospital’s four walls?” he noted.

“One of the reasons our smaller hospital reached capacity with COVID-19 patients was the skilled nursing facility located a few hundred feet away that turned into a hot spot. If we had imported the hospital medicine model virtually into that SNF early on, could there have been a different scenario? Have we thought through what that would have even looked like?” Dr. Whelan asked.

He challenges the hospital medicine field, once it gets to the other side of this crisis, to not fall back on old way of doing things. “Instead, let’s use this time to create a better model today,” he said. “That’s what we’re trying to do at a system level at Banner, with our hospital medicine groups partnering with the hospital. I want to see our hospitalists create and thrive in that new model.”

Hospitalists nationwide have put in longer hours, played new clinical roles, and stretched beyond their medical specialty and comfort level to meet their hospital’s COVID-19 care demands. Can they expect some kind of financial recognition – perhaps in the form of “hazard pay” for going above and beyond – even though their institutions are experiencing negative financial fallout from the crisis?

Dr. Ron Greeno

Hospitals in regions experiencing a COVID-19 surge have limited elective procedures, discouraged non–COVID-19 admissions, and essentially entered crisis management mode. Other facilities in less hard-hit communities are also standing by, with reduced hospital census, smaller caseloads and less work to do, while trying to prepare their bottom lines for lower demand.

“This crisis has put most hospitals in financial jeopardy and that is likely to trickle down to all employees – including hospitalists,” said Ron Greeno, MD, FCCP, MHM, a past president of SHM and the society’s current senior advisor for government affairs. “But it’s not like hospitals could or would forgo an effective hospitalist program today. Hospitalists will be important players in defining the hospital’s future direction post crisis.”

That doesn’t mean tighter financials, caps on annual salary increases, or higher productivity expectations won’t be part of future conversations between hospital administrators and their hospitalists, Dr. Greeno said. Administrators are starting to look ahead to the post–COVID-19 era even as numbers of cases and rates of growth continue to rise in various regions, and Dr. Greeno sees a lot of uncertainty ahead.

Even prior to the crisis, he noted, hospital margins had been falling, while the cost of labor, including hospitalist labor, was going up. That was pointing toward an inevitable collision, which has only intensified with the new financial crisis facing hospitals – created by SARS-CoV-2 and by policies such as shutting down elective surgeries in anticipation of a COVID-19 patient surge that, for some institutions, may never come.

Dr. Brian Harte

Brian Harte, MD, MHM, president of Cleveland Clinic Akron General and a past president of SHM, said that the Cleveland Clinic system has been planning since January its response to the coming crisis. “Governor Mike DeWine and the state Department of Health led the way in flattening the curve in Ohio. We engaged our hospitalists in brainstorming solutions. They have been excellent partners,” he said.

Approaching the crisis with a sense of urgency from the outset, the Cleveland Clinic built a COVID-19 surge team and incident command structure, with nursing, infectious diseases, critical care and hospital medicine represented. “We used that time to get ready for what was coming. We worked on streamlining consultant work flows.”

But utilization numbers are off in almost every service line, Dr. Harte said. “It has forced us to look at things we’ve always talked about, including greater use of telemedicine and exploring other ways of caring for patients, such as increased use of evening hours.”

Cleveland Clinic contracts with Sound Physicians of Tacoma, Wash., for its hospitalist coverage. “We have an excellent working relationship with Sound at the local, regional, and national levels, with common goals for quality and utilization. We tried to involve our hospitalists as early as possible in planning. We needed them to step in and role model and lead the way,” Dr. Harte said, for everybody’s anxiety levels.

“We’re still in the process of understanding the long-term financial impact of the epidemic,” Dr. Harte added. “But at this point I see no reason to think our relationship with our hospitalists needs to change. We’re the stewards of long-term finances. We’ll need to keep a close eye on this. But we’re committed to working through this together.”

Hazard pay for frontline health care workers was included in the COVID-19 relief package assembled in mid-May by Democrats in the House of Representatives. The $3 trillion HEROES Act includes $200 billion to award hazard pay to essential workers, including those in the health field, but Senate Majority Leader Mitch McConnell (R-Ky.) declared the legislation “dead on arrival” in the Senate.

Supplementary hazard payments made by hospitals to their hospitalists as a reward for sacrifices they made in the crisis is an interesting question, Dr. Greeno noted, and it’s definitely on the table at some hospitals. “But I think it is going to be a tough ask in these times.”

Dr. Harte said he has not offered nor been asked about hazard pay for hospitalists. Cleveland Clinic Akron General made a strategic decision that hazard pay was not going to be part of its response to the pandemic. Other hospital administrators interviewed for this article concur.

 

 

Hospitals respond to the fiscal crisis

Hospitals in other parts of the country also report significant fiscal fallout from the COVID-19 crisis, with predictions that 100 or more hospitals may be forced to close. Jeff Dye, president of the New Mexico Hospital Association, told the Albuquerque Journal on May 1 that hospitals in his state have been squeezed on all sides by increased costs, patients delaying routine care, and public health orders restricting elective surgeries. New Mexico hospitals, especially in rural areas, face incredible financial strain.

The University of Virginia Medical Center, Charlottesville, recently announced 20% reductions in total compensation for its providers through July 31, along with suspension of retirement contributions. Those changes won’t affect team members caring for COVID-19 patients. And the Spectrum Health Medical Group of 15 hospitals in western Michigan, according to Michigan Public Radio, told its doctors they either needed to sign “contract addendums” giving the system more control over their hours – or face a 25% pay cut, or worse.

Cheyenne (Wyo.) Regional Medical Center issued a statement April 24 that it expected losses of $10 million for the month of April. “CRMC, like every other hospital in Wyoming, is certainly feeling the financial impact that COVID-19 is having,” CEO Tim Thornell told the Cowboy State Daily on April 24. That includes a 30% reduction in inpatient care and 50% reduction in outpatient care, while the hospital has only had a handful of COVID-19 patients at any time. Capital projects are now on hold, overtime is limited, and a hiring freeze is in effect.

“We’re certainly prepared for a larger surge, which hasn’t come yet,” Mr. Thornell said in an interview. CRMC’s ICU was split to create a nine-bed dedicated COVID-19 unit. Intensivists see most of the critical care patients, while the hospital’s 15 directly-employed hospitalists are treating all of the non-ICU COVID-19 patients. “Among themselves, the hospitalists volunteered who would work on the unit. We’ve been fortunate enough to have enough volunteers and enough PPE [personal protective equipment],” he said.

Preparing for the COVID-19 pandemic has strengthened the medical center’s relationship with its hospitalists, Mr. Thornell explained. “Hospitalists are key to our operations, involved in so much that happens here. We’re trying to staff to volume with decreased utilization. We’ve scaled back, which only makes fiscal sense. Now, how do we reinfuse patients back into the mix? Our hospitalists are paid by the number of shifts, and as you distribute shift reductions over 15 providers, it shouldn’t be an intolerable burden.” But two open hospitalist positions have not been filled, he noted.

CRMC is trying to approach these changes with a Lean perspective, Mr. Thornell said. “We had already adopted a Lean program, but this has been a chance to go through a life-altering circumstance using the tools of Lean planning and applying them instantaneously.”
 

Providers step up

At Emory Healthcare in Atlanta, a major center for COVID-19 cases, communication has been essential in the crisis, said Bryce Gartland, MD, SFHM, Emory’s hospital group president and cochief of clinical operations. “Our group was prepared for a significant influx of patients. Like every other institution, we made the decision to postpone elective care, with a resulting plummet in volume,” he said.

Dr. Bryce Gartland

As COVID-19 patients entered the Emory system, frontline hospitalists stepped up to care for those patients. “We’ve had ample providers in terms of clinical care. We guaranteed our physicians’ base compensation. They have flexed teams up and down as needed.” Advanced practice professionals also stepped up to bridge gaps.

With regard to the return of volumes of non–COVID-19 patients, the jury’s still out, Dr. Gartland said. “None of us has a crystal ball, and there are tremendous variables and decision points that will have significant impact. We have started to see numbers of time-sensitive and essential cases increase as of the first week of May.”

What lies ahead will likely include some rightsizing to future volumes. On top of that, the broader economic pressures on hospitals from high rates of unemployment, uninsured patients, bad debt, and charity care will push health care systems to significantly address costs and infrastructure, he said. “We’re still early in planning, and striving to maintain flexibility and nimbleness, given the uncertainties to this early understanding of our new normal. No hospital is immune from the financial impact. We’ll see and hear about more of these conversations in the months ahead.”

But the experience has also generated some positives, Dr. Gartland noted. “Things like telehealth, which we’ve been talking about for years but previously faced barriers to widespread adoption.” Now with COVID-19, the federal government issued waivers, and barriers – both internal and external – came down. “With telehealth, what will the role and deployment of hospitalists look like in this new model? How will traditional productivity expectations change, or the numbers and types of providers? This will make the relationship and partnership between hospitalist groups and hospital administrators ever more important as we consider the evolution toward new care models.”

Dr. Gartland said that “one of the great things about hospital medicine as a field is its flexibility and adaptability. Where there have been gaps, hospitalists were quick to step in. As long as hospital medicine continues to embrace those kinds of behaviors, it will be successful.” But if the conversation with hospitals is just about money, it will be harder, he acknowledged. “Where there is this kind of disruption in our usual way of doing things, there are also tremendous opportunities for care model innovation. I would encourage hospitalist groups to try to be true value partners.”

Command center mode

Like other physicians in hospital C-suites, Chad Whelan MD, FACP, SFHM, chief executive officer of Banner–University Medicine in Tucson, Ariz., led his two hospitals into command center mode when the crisis hit, planning for a surge of COVID-19 cases that could overwhelm hospital capacity.

Dr. Chad T. Whelan

“In terms of our hospitalists, we leaned in to them hard in the beginning, preparing them to supervise other physicians who came in to help if needed,” he said. “Our [non–COVID-19] census is down, revenues are down, and the implications are enormous – like nothing we’ve ever seen before.”

“We’re fortunate that we’re part of the Banner health system. We made a decision that we would essentially keep our physicians financially protected through this crisis,” Dr. Whelan said. “In return, we called on them to step up and be on the front lines and to put in enormous hours for planning. We asked them to consider: How could you contribute if the surge comes?”

He affirmed that hospital medicine has been a major part of his medical center’s planning and implementation. “I’ve been overwhelmed by the degree to which the entire delivery team has rallied around the pandemic, with everybody saying they want to keep people safe and be part of the solution. We have always had hospitalist leaders at the table as we’ve planned our response and as decisions were made,” said Dr. Whelan, a practicing hospitalist and teaching service attending since 2000 until he assumed his current executive position in Arizona 18 months ago.

“While we have kept people whole during the immediate crisis, we have acknowledged that we don’t know what our recovery will look like. What if [non–COVID-19] volume doesn’t return? That keeps me awake at night,” he said. “I have talked to our physician leadership in hospital medicine and more broadly. We need to ask ourselves many questions, including: do we have the right levels of staffing? Is this the time to consider alternate models of staffing, for example, advanced practice providers? And does the compensation plan need adjustments?”

Dr. Whelan thinks that the COVID-19 crisis is an opportunity for hospital medicine to more rapidly explore different models and to ask what additional value hospitalists can bring to the care model. “For example, what would it mean to redefine the hospitalist’s scope of practice as an acute medicine specialist, not defined by the hospital’s four walls?” he noted.

“One of the reasons our smaller hospital reached capacity with COVID-19 patients was the skilled nursing facility located a few hundred feet away that turned into a hot spot. If we had imported the hospital medicine model virtually into that SNF early on, could there have been a different scenario? Have we thought through what that would have even looked like?” Dr. Whelan asked.

He challenges the hospital medicine field, once it gets to the other side of this crisis, to not fall back on old way of doing things. “Instead, let’s use this time to create a better model today,” he said. “That’s what we’re trying to do at a system level at Banner, with our hospital medicine groups partnering with the hospital. I want to see our hospitalists create and thrive in that new model.”

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A 36-year-old presents with a mildly pruritic rash consisting of pink papules on his hand

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Majocchi granuloma (MG), a clinical variant of tinea corporis, is also known as fungal folliculitis and tinea incognito. MG is a dermatophytic folliculitis that classically presents as folliculocentric plaque, in which there are papules, pustules, and nodules, usually found on the lower leg and almost exclusively in adults.1 Wrists are commonly affected as well.

Kevin Hakimi, University of California, San Diego School of Medicine


MG is typically caused by mechanical disruption of hair follicles that allows fungi to penetrate deep into dermal tissue.2 Quite often, the source of infection is typically the patient’s skin or nails. Associated risk factors include longstanding fungal infection, shaving or other cutaneous trauma, topical steroids, and immunosuppressive therapy.3,4 Although MG can be caused by other fungal species, it is most often caused by Trichophyton rubrum or Trichophyton tonsurans.1 There are two types of MG, the perifollicular papular form, which is localized and typically occurs in healthy individuals, and the deep subcutaneous plaque or nodular forms that usually occur in immunocompromised individuals.5

MG is an important clinical manifestation to be familiar with because of the increase in the numbers of solid-organ transplants and patients on immunosuppressive therapies. These patients are highly predisposed to opportunistic infections with aggressive clinical courses and will usually require prolonged treatment as relapses are common.3,5
Dr. Brooke Sateesh

Tissue culture and skin biopsy are often needed to establish the diagnosis. If a topical antifungal has been used, KOH (potassium hydroxide) and culture may be negative. This patient’s tissue culture was positive for T. rubrum. The histopathology revealed hyperkeratosis and acanthosis with focal parakeratosis and a lymphohistiocytic infiltrate in the dermis. On PAS (Periodic acid–Schiff ) stain, PAS-positive hyphae were identified in the keratin layer, confirming a diagnosis of tinea infection.
 

First line treatment includes systemic antifungals such as griseofulvin, ketoconazole, itraconazole, and terbinafine. Duration of therapy is typically 4-8 weeks or until all lesions are cleared.3,5
 

This case and photo were submitted by Mr. Hakimi of University of California San Diego School of Medicine and Dr. Sateesh of San Diego Family Dermatology. Donna Bilu Martin, MD, edited the column.

Dr. Donna Bilu Martin

Dr. Bilu Martin is a board-certified dermatologist in private practice at Premier Dermatology, MD, in Aventura, Fla. More diagnostic cases are available at mdedge.com/dermatology. To submit a case for possible publication, send an email to [email protected].

References

1.“Fitzpatrick’s Dermatology in General Medicine” (New York: McGraw-Hill Medical, 2012).

2. Bonifaz A et al. Gac Med Mex. Sep-Oct 2008;144(5):427-33.

3. Romero FA et al. Transpl Infect Dis. 2011 Aug;13(4):424-3. doi:10.1111/j.1399-3062.2010.00596.x

4. Chou WY, Hsu CJ. Medicine (Baltimore). 2016 Jan;95(2):e2245. doi: 10.1097/MD.0000000000002245.

5. Ilkit M et al. Med Mycol. 2102 Jul;50(5):449-57.

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Majocchi granuloma (MG), a clinical variant of tinea corporis, is also known as fungal folliculitis and tinea incognito. MG is a dermatophytic folliculitis that classically presents as folliculocentric plaque, in which there are papules, pustules, and nodules, usually found on the lower leg and almost exclusively in adults.1 Wrists are commonly affected as well.

Kevin Hakimi, University of California, San Diego School of Medicine


MG is typically caused by mechanical disruption of hair follicles that allows fungi to penetrate deep into dermal tissue.2 Quite often, the source of infection is typically the patient’s skin or nails. Associated risk factors include longstanding fungal infection, shaving or other cutaneous trauma, topical steroids, and immunosuppressive therapy.3,4 Although MG can be caused by other fungal species, it is most often caused by Trichophyton rubrum or Trichophyton tonsurans.1 There are two types of MG, the perifollicular papular form, which is localized and typically occurs in healthy individuals, and the deep subcutaneous plaque or nodular forms that usually occur in immunocompromised individuals.5

MG is an important clinical manifestation to be familiar with because of the increase in the numbers of solid-organ transplants and patients on immunosuppressive therapies. These patients are highly predisposed to opportunistic infections with aggressive clinical courses and will usually require prolonged treatment as relapses are common.3,5
Dr. Brooke Sateesh

Tissue culture and skin biopsy are often needed to establish the diagnosis. If a topical antifungal has been used, KOH (potassium hydroxide) and culture may be negative. This patient’s tissue culture was positive for T. rubrum. The histopathology revealed hyperkeratosis and acanthosis with focal parakeratosis and a lymphohistiocytic infiltrate in the dermis. On PAS (Periodic acid–Schiff ) stain, PAS-positive hyphae were identified in the keratin layer, confirming a diagnosis of tinea infection.
 

First line treatment includes systemic antifungals such as griseofulvin, ketoconazole, itraconazole, and terbinafine. Duration of therapy is typically 4-8 weeks or until all lesions are cleared.3,5
 

This case and photo were submitted by Mr. Hakimi of University of California San Diego School of Medicine and Dr. Sateesh of San Diego Family Dermatology. Donna Bilu Martin, MD, edited the column.

Dr. Donna Bilu Martin

Dr. Bilu Martin is a board-certified dermatologist in private practice at Premier Dermatology, MD, in Aventura, Fla. More diagnostic cases are available at mdedge.com/dermatology. To submit a case for possible publication, send an email to [email protected].

References

1.“Fitzpatrick’s Dermatology in General Medicine” (New York: McGraw-Hill Medical, 2012).

2. Bonifaz A et al. Gac Med Mex. Sep-Oct 2008;144(5):427-33.

3. Romero FA et al. Transpl Infect Dis. 2011 Aug;13(4):424-3. doi:10.1111/j.1399-3062.2010.00596.x

4. Chou WY, Hsu CJ. Medicine (Baltimore). 2016 Jan;95(2):e2245. doi: 10.1097/MD.0000000000002245.

5. Ilkit M et al. Med Mycol. 2102 Jul;50(5):449-57.

Majocchi granuloma (MG), a clinical variant of tinea corporis, is also known as fungal folliculitis and tinea incognito. MG is a dermatophytic folliculitis that classically presents as folliculocentric plaque, in which there are papules, pustules, and nodules, usually found on the lower leg and almost exclusively in adults.1 Wrists are commonly affected as well.

Kevin Hakimi, University of California, San Diego School of Medicine


MG is typically caused by mechanical disruption of hair follicles that allows fungi to penetrate deep into dermal tissue.2 Quite often, the source of infection is typically the patient’s skin or nails. Associated risk factors include longstanding fungal infection, shaving or other cutaneous trauma, topical steroids, and immunosuppressive therapy.3,4 Although MG can be caused by other fungal species, it is most often caused by Trichophyton rubrum or Trichophyton tonsurans.1 There are two types of MG, the perifollicular papular form, which is localized and typically occurs in healthy individuals, and the deep subcutaneous plaque or nodular forms that usually occur in immunocompromised individuals.5

MG is an important clinical manifestation to be familiar with because of the increase in the numbers of solid-organ transplants and patients on immunosuppressive therapies. These patients are highly predisposed to opportunistic infections with aggressive clinical courses and will usually require prolonged treatment as relapses are common.3,5
Dr. Brooke Sateesh

Tissue culture and skin biopsy are often needed to establish the diagnosis. If a topical antifungal has been used, KOH (potassium hydroxide) and culture may be negative. This patient’s tissue culture was positive for T. rubrum. The histopathology revealed hyperkeratosis and acanthosis with focal parakeratosis and a lymphohistiocytic infiltrate in the dermis. On PAS (Periodic acid–Schiff ) stain, PAS-positive hyphae were identified in the keratin layer, confirming a diagnosis of tinea infection.
 

First line treatment includes systemic antifungals such as griseofulvin, ketoconazole, itraconazole, and terbinafine. Duration of therapy is typically 4-8 weeks or until all lesions are cleared.3,5
 

This case and photo were submitted by Mr. Hakimi of University of California San Diego School of Medicine and Dr. Sateesh of San Diego Family Dermatology. Donna Bilu Martin, MD, edited the column.

Dr. Donna Bilu Martin

Dr. Bilu Martin is a board-certified dermatologist in private practice at Premier Dermatology, MD, in Aventura, Fla. More diagnostic cases are available at mdedge.com/dermatology. To submit a case for possible publication, send an email to [email protected].

References

1.“Fitzpatrick’s Dermatology in General Medicine” (New York: McGraw-Hill Medical, 2012).

2. Bonifaz A et al. Gac Med Mex. Sep-Oct 2008;144(5):427-33.

3. Romero FA et al. Transpl Infect Dis. 2011 Aug;13(4):424-3. doi:10.1111/j.1399-3062.2010.00596.x

4. Chou WY, Hsu CJ. Medicine (Baltimore). 2016 Jan;95(2):e2245. doi: 10.1097/MD.0000000000002245.

5. Ilkit M et al. Med Mycol. 2102 Jul;50(5):449-57.

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A 36-year-old male with a history of treated hepatitis C presented with a mildly pruritic rash consisting of pink papules on his right hand for 2 months. Over a 2-month course, he had multiple treatments, including intralesional triamcinolone, oral fluconazole, fluocinonide lotion, doxycycline, and methylprednisolone (a Medrol Dosepak). The patient works in construction and has an aquarium with a turtle at home. A biopsy for hematoxylin and eosin (H&E) and tissue culture were performed.

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Humira topped drug-revenue list for 2019

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Tue, 02/07/2023 - 16:48

Humira outsold all other drugs in 2019 in terms of revenue as cytokine inhibitor medications earned their way to three of the first four spots on the pharmaceutical best-seller list, according to a new analysis from the IQVIA Institute for Human Data Science.

Sales of Humira (adalimumab) amounted to $21.4 billion before discounting, Murray Aitken, the institute’s executive director, and associates wrote in their analysis. That’s more than double the total of the anticoagulant Eliquis (apixaban), which brought in $9.9 billion in its last year before generic forms became available.

The next two spots were filled by the tumor necrosis factor inhibitor Enbrel (etanercept) with $8.1 billion in sales and the interleukin 12/23 inhibitor Stelara (ustekinumab) with sales totaling $6.6 billion, followed by the chemotherapy drug Keytruda (pembrolizumab) close behind after racking up $6.5 billion in sales, the researchers reported.

Total nondiscounted spending on all drugs in the U.S. market came to $511 billion in 2019, an increase of 5.7% over the $484 billion spent in 2018, based on data from the July 2020 IQVIA National Sales Perspectives.



These figures are “not adjusted for estimates of off-invoice discounts and rebates,” the authors noted, but they include “prescription and insulin products sold into chain and independent pharmacies, food store pharmacies, mail service pharmacies, long-term care facilities, hospitals, clinics, and other institutional settings.”

Those “discounts and rebates” do exist, however, and they can add up. Drug sales for 2019, “after deducting negotiated rebates, discounts, and other forms of price concessions, such as patient coupons or vouchers that offset out-of-pocket costs,” were $235 billion less than overall nondiscounted spending, the report noted.

Now that we’ve shown you the money, let’s take a quick look at volume. The leading drugs by number of dispensed prescriptions in 2019 were, not surprisingly, quite different. First, with 118 million prescriptions, was atorvastatin, followed by levothyroxine (113 million), lisinopril (96), amlodipine (89), and metoprolol (85), Mr. Aitken and associates reported.

Altogether, over 4.2 billion prescriptions were dispensed last year, with a couple of caveats: 90-day and 30-day fills were both counted as one prescription, and OTC drugs were not included, they pointed out.

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Humira outsold all other drugs in 2019 in terms of revenue as cytokine inhibitor medications earned their way to three of the first four spots on the pharmaceutical best-seller list, according to a new analysis from the IQVIA Institute for Human Data Science.

Sales of Humira (adalimumab) amounted to $21.4 billion before discounting, Murray Aitken, the institute’s executive director, and associates wrote in their analysis. That’s more than double the total of the anticoagulant Eliquis (apixaban), which brought in $9.9 billion in its last year before generic forms became available.

The next two spots were filled by the tumor necrosis factor inhibitor Enbrel (etanercept) with $8.1 billion in sales and the interleukin 12/23 inhibitor Stelara (ustekinumab) with sales totaling $6.6 billion, followed by the chemotherapy drug Keytruda (pembrolizumab) close behind after racking up $6.5 billion in sales, the researchers reported.

Total nondiscounted spending on all drugs in the U.S. market came to $511 billion in 2019, an increase of 5.7% over the $484 billion spent in 2018, based on data from the July 2020 IQVIA National Sales Perspectives.



These figures are “not adjusted for estimates of off-invoice discounts and rebates,” the authors noted, but they include “prescription and insulin products sold into chain and independent pharmacies, food store pharmacies, mail service pharmacies, long-term care facilities, hospitals, clinics, and other institutional settings.”

Those “discounts and rebates” do exist, however, and they can add up. Drug sales for 2019, “after deducting negotiated rebates, discounts, and other forms of price concessions, such as patient coupons or vouchers that offset out-of-pocket costs,” were $235 billion less than overall nondiscounted spending, the report noted.

Now that we’ve shown you the money, let’s take a quick look at volume. The leading drugs by number of dispensed prescriptions in 2019 were, not surprisingly, quite different. First, with 118 million prescriptions, was atorvastatin, followed by levothyroxine (113 million), lisinopril (96), amlodipine (89), and metoprolol (85), Mr. Aitken and associates reported.

Altogether, over 4.2 billion prescriptions were dispensed last year, with a couple of caveats: 90-day and 30-day fills were both counted as one prescription, and OTC drugs were not included, they pointed out.

Humira outsold all other drugs in 2019 in terms of revenue as cytokine inhibitor medications earned their way to three of the first four spots on the pharmaceutical best-seller list, according to a new analysis from the IQVIA Institute for Human Data Science.

Sales of Humira (adalimumab) amounted to $21.4 billion before discounting, Murray Aitken, the institute’s executive director, and associates wrote in their analysis. That’s more than double the total of the anticoagulant Eliquis (apixaban), which brought in $9.9 billion in its last year before generic forms became available.

The next two spots were filled by the tumor necrosis factor inhibitor Enbrel (etanercept) with $8.1 billion in sales and the interleukin 12/23 inhibitor Stelara (ustekinumab) with sales totaling $6.6 billion, followed by the chemotherapy drug Keytruda (pembrolizumab) close behind after racking up $6.5 billion in sales, the researchers reported.

Total nondiscounted spending on all drugs in the U.S. market came to $511 billion in 2019, an increase of 5.7% over the $484 billion spent in 2018, based on data from the July 2020 IQVIA National Sales Perspectives.



These figures are “not adjusted for estimates of off-invoice discounts and rebates,” the authors noted, but they include “prescription and insulin products sold into chain and independent pharmacies, food store pharmacies, mail service pharmacies, long-term care facilities, hospitals, clinics, and other institutional settings.”

Those “discounts and rebates” do exist, however, and they can add up. Drug sales for 2019, “after deducting negotiated rebates, discounts, and other forms of price concessions, such as patient coupons or vouchers that offset out-of-pocket costs,” were $235 billion less than overall nondiscounted spending, the report noted.

Now that we’ve shown you the money, let’s take a quick look at volume. The leading drugs by number of dispensed prescriptions in 2019 were, not surprisingly, quite different. First, with 118 million prescriptions, was atorvastatin, followed by levothyroxine (113 million), lisinopril (96), amlodipine (89), and metoprolol (85), Mr. Aitken and associates reported.

Altogether, over 4.2 billion prescriptions were dispensed last year, with a couple of caveats: 90-day and 30-day fills were both counted as one prescription, and OTC drugs were not included, they pointed out.

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Oleander extract for COVID-19? That’s a hard ‘no’ experts say

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Thu, 08/26/2021 - 16:01

Oleandrin, a toxic cardiac glycoside found in the poisonous oleander plant, is making headlines as a potential treatment for COVID-19, raising concerns that uninformed people may eat the leaves of the plant and become ill or die.

CANCER CIFTCI/Getty Images

“Though renowned for its beauty and use in landscaping, this Mediterranean shrub is responsible for cases of accidental poisoning across the globe. All parts of the plant are poisonous,” Cassandra Quave, PhD, ethnobotanist and herbarium curator at Emory University, Atlanta, cautioned in an article in The Conversation, an independent, not-for-profit publication.

Oleandrin has properties similar to digoxin; the onset of toxicity occurs several hours after consumption.

The first symptoms of oleandrin poisoning may be gastrointestinal, such as nausea, vomiting, abdominal pain, diarrhea (which may contain blood), and loss of appetite.

After these first symptoms, the heart may be affected by tachyarrhythmia, bradyarrhythmia, premature ventricular contractions, or atrioventricular blockage. Xanthopsia (yellow vision), a burning sensation in the eyes, paralysis of the gastrointestinal tract, and respiratory symptoms may also occur.

Oleandrin poisoning may affect the central nervous system, as evidenced by drowsiness, tremors, seizures, collapse, and coma leading to death. When applied to the skin, oleander sap can cause skin irritations and allergic reactions characterized by dermatitis.

Diagnosis of oleandrin poisoning is mainly made on the basis of a description of the plant, how much of it was ingested, how much time has elapsed since ingestion, and symptoms. Confirmation of oleandrin in blood involves fluorescence polarization immunoassay, digoxin immunoassay, or liquid chromatography-electrospray tandem mass spectrometry.

Neither oleander nor oleandrin is approved by regulatory agencies as a prescription drug or dietary supplement.
 

In vitro study

Oleandrin for COVID-19 made headlines after President Trump met in the Oval Office with Andrew Whitney, vice chairman and director of Phoenix Biotechnology, along with Housing and Urban Development Secretary Ben Carson, MD, and MyPillow founder/CEO Mike Lindell, a strong supporter of Trump and an investor in the biotech company, to learn about oleandrin, which Whitney called a “cure” for COVID-19, Axios reported.

In an in vitro study, researchers from Phoenix Biotechnology and the University of Texas Medical Branch, Galveston, tested oleandrin against SARS-CoV-2 in cultured Vero cells.

“When administered both before and after virus infection, nanogram doses of oleandrin significantly inhibited replication by 45 to 3000-fold,” the researchers said in an article posted on bioRxiv, a free online archive and distribution service for unpublished preprints in the life sciences. The study has not been peer reviewed.

On the basis of these in vitro findings, the researchers said the plant extract has “potential to prevent disease and virus spread in persons recently exposed to SARS-CoV-2, as well as to prevent severe disease in persons at high risk.”

But it’s a far cry from test tube to human, one expert cautioned.

“This is an understatement: Care must be taken when inferring potential therapeutic benefits from in vitro antiviral effects,” Harlan Krumholz, MD, cardiologist and director, Yale New Haven Hospital Center for Outcomes Research and Evaluation, New Haven, Connecticut, told Medscape Medical News.

“There is a chasm between a single in vitro study and any use in humans outside of a protocol. People should be cautioned about that distance and the need [to] avoid such remedies unless part of a credible research project,” said Krumholz.

Yet Lindell told Axios that, in the Oval Office meeting, Trump expressed enthusiasm for the Food and Drug Administration to allow oleandrin to be marketed as a dietary supplement or approved for COVID-19.

“This is really just nonsense and a distraction,” Jonathan Reiner, MD, of George Washington University Medical Center, Washington, DC, said on CNN.

This article first appeared on Medscape.com.

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Oleandrin, a toxic cardiac glycoside found in the poisonous oleander plant, is making headlines as a potential treatment for COVID-19, raising concerns that uninformed people may eat the leaves of the plant and become ill or die.

CANCER CIFTCI/Getty Images

“Though renowned for its beauty and use in landscaping, this Mediterranean shrub is responsible for cases of accidental poisoning across the globe. All parts of the plant are poisonous,” Cassandra Quave, PhD, ethnobotanist and herbarium curator at Emory University, Atlanta, cautioned in an article in The Conversation, an independent, not-for-profit publication.

Oleandrin has properties similar to digoxin; the onset of toxicity occurs several hours after consumption.

The first symptoms of oleandrin poisoning may be gastrointestinal, such as nausea, vomiting, abdominal pain, diarrhea (which may contain blood), and loss of appetite.

After these first symptoms, the heart may be affected by tachyarrhythmia, bradyarrhythmia, premature ventricular contractions, or atrioventricular blockage. Xanthopsia (yellow vision), a burning sensation in the eyes, paralysis of the gastrointestinal tract, and respiratory symptoms may also occur.

Oleandrin poisoning may affect the central nervous system, as evidenced by drowsiness, tremors, seizures, collapse, and coma leading to death. When applied to the skin, oleander sap can cause skin irritations and allergic reactions characterized by dermatitis.

Diagnosis of oleandrin poisoning is mainly made on the basis of a description of the plant, how much of it was ingested, how much time has elapsed since ingestion, and symptoms. Confirmation of oleandrin in blood involves fluorescence polarization immunoassay, digoxin immunoassay, or liquid chromatography-electrospray tandem mass spectrometry.

Neither oleander nor oleandrin is approved by regulatory agencies as a prescription drug or dietary supplement.
 

In vitro study

Oleandrin for COVID-19 made headlines after President Trump met in the Oval Office with Andrew Whitney, vice chairman and director of Phoenix Biotechnology, along with Housing and Urban Development Secretary Ben Carson, MD, and MyPillow founder/CEO Mike Lindell, a strong supporter of Trump and an investor in the biotech company, to learn about oleandrin, which Whitney called a “cure” for COVID-19, Axios reported.

In an in vitro study, researchers from Phoenix Biotechnology and the University of Texas Medical Branch, Galveston, tested oleandrin against SARS-CoV-2 in cultured Vero cells.

“When administered both before and after virus infection, nanogram doses of oleandrin significantly inhibited replication by 45 to 3000-fold,” the researchers said in an article posted on bioRxiv, a free online archive and distribution service for unpublished preprints in the life sciences. The study has not been peer reviewed.

On the basis of these in vitro findings, the researchers said the plant extract has “potential to prevent disease and virus spread in persons recently exposed to SARS-CoV-2, as well as to prevent severe disease in persons at high risk.”

But it’s a far cry from test tube to human, one expert cautioned.

“This is an understatement: Care must be taken when inferring potential therapeutic benefits from in vitro antiviral effects,” Harlan Krumholz, MD, cardiologist and director, Yale New Haven Hospital Center for Outcomes Research and Evaluation, New Haven, Connecticut, told Medscape Medical News.

“There is a chasm between a single in vitro study and any use in humans outside of a protocol. People should be cautioned about that distance and the need [to] avoid such remedies unless part of a credible research project,” said Krumholz.

Yet Lindell told Axios that, in the Oval Office meeting, Trump expressed enthusiasm for the Food and Drug Administration to allow oleandrin to be marketed as a dietary supplement or approved for COVID-19.

“This is really just nonsense and a distraction,” Jonathan Reiner, MD, of George Washington University Medical Center, Washington, DC, said on CNN.

This article first appeared on Medscape.com.

Oleandrin, a toxic cardiac glycoside found in the poisonous oleander plant, is making headlines as a potential treatment for COVID-19, raising concerns that uninformed people may eat the leaves of the plant and become ill or die.

CANCER CIFTCI/Getty Images

“Though renowned for its beauty and use in landscaping, this Mediterranean shrub is responsible for cases of accidental poisoning across the globe. All parts of the plant are poisonous,” Cassandra Quave, PhD, ethnobotanist and herbarium curator at Emory University, Atlanta, cautioned in an article in The Conversation, an independent, not-for-profit publication.

Oleandrin has properties similar to digoxin; the onset of toxicity occurs several hours after consumption.

The first symptoms of oleandrin poisoning may be gastrointestinal, such as nausea, vomiting, abdominal pain, diarrhea (which may contain blood), and loss of appetite.

After these first symptoms, the heart may be affected by tachyarrhythmia, bradyarrhythmia, premature ventricular contractions, or atrioventricular blockage. Xanthopsia (yellow vision), a burning sensation in the eyes, paralysis of the gastrointestinal tract, and respiratory symptoms may also occur.

Oleandrin poisoning may affect the central nervous system, as evidenced by drowsiness, tremors, seizures, collapse, and coma leading to death. When applied to the skin, oleander sap can cause skin irritations and allergic reactions characterized by dermatitis.

Diagnosis of oleandrin poisoning is mainly made on the basis of a description of the plant, how much of it was ingested, how much time has elapsed since ingestion, and symptoms. Confirmation of oleandrin in blood involves fluorescence polarization immunoassay, digoxin immunoassay, or liquid chromatography-electrospray tandem mass spectrometry.

Neither oleander nor oleandrin is approved by regulatory agencies as a prescription drug or dietary supplement.
 

In vitro study

Oleandrin for COVID-19 made headlines after President Trump met in the Oval Office with Andrew Whitney, vice chairman and director of Phoenix Biotechnology, along with Housing and Urban Development Secretary Ben Carson, MD, and MyPillow founder/CEO Mike Lindell, a strong supporter of Trump and an investor in the biotech company, to learn about oleandrin, which Whitney called a “cure” for COVID-19, Axios reported.

In an in vitro study, researchers from Phoenix Biotechnology and the University of Texas Medical Branch, Galveston, tested oleandrin against SARS-CoV-2 in cultured Vero cells.

“When administered both before and after virus infection, nanogram doses of oleandrin significantly inhibited replication by 45 to 3000-fold,” the researchers said in an article posted on bioRxiv, a free online archive and distribution service for unpublished preprints in the life sciences. The study has not been peer reviewed.

On the basis of these in vitro findings, the researchers said the plant extract has “potential to prevent disease and virus spread in persons recently exposed to SARS-CoV-2, as well as to prevent severe disease in persons at high risk.”

But it’s a far cry from test tube to human, one expert cautioned.

“This is an understatement: Care must be taken when inferring potential therapeutic benefits from in vitro antiviral effects,” Harlan Krumholz, MD, cardiologist and director, Yale New Haven Hospital Center for Outcomes Research and Evaluation, New Haven, Connecticut, told Medscape Medical News.

“There is a chasm between a single in vitro study and any use in humans outside of a protocol. People should be cautioned about that distance and the need [to] avoid such remedies unless part of a credible research project,” said Krumholz.

Yet Lindell told Axios that, in the Oval Office meeting, Trump expressed enthusiasm for the Food and Drug Administration to allow oleandrin to be marketed as a dietary supplement or approved for COVID-19.

“This is really just nonsense and a distraction,” Jonathan Reiner, MD, of George Washington University Medical Center, Washington, DC, said on CNN.

This article first appeared on Medscape.com.

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