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Oncologist to insurer: ‘This denial will not stand’
“Is this really the hill you want to die on?” asked Rebecca Shatsky, MD, a medical oncologist at the University of California, San Diego.
It was Nov. 18 and Dr. Shatsky was on the phone with a retired oncologist working for the health insurance company Premera Blue Cross.
Dr. Shatsky was appealing a prior authorization denial for pembrolizumab (Keytruda) to treat her patient with stage IIIc triple-negative breast cancer (TNBC). She hoped the peer-to-peer would reverse the denial. The Food and Drug Administration had approved the immunotherapy for people with high-risk TNBC both in the neoadjuvant setting alongside chemotherapy and, in her patient’s case, as a single-agent adjuvant treatment based on data from the KEYNOTE 522 trial.
In the peer-to-peer, Dr. Shatsky laid out the evidence, but she could tell the physician wasn’t going to budge.
When she pressed him further, asking why he was denying potentially lifesaving care for her patient, he said the data on whether patients really need adjuvant pembrolizumab were not clear yet.
“The man – who was not a breast oncologist – was essentially mansplaining breast oncology to me,” she said in an interview. “I don’t need a nonexpert giving me their misinterpretation of the data.”
Dr. Shatsky informed him that this decision would not stand. She would be escalating the claim.
“I’m not going to let you get in way of my patient’s survival,” Dr. Shatsky told the physician during the peer-to-peer. “We have one shot to cure this, and if we don’t do it now, patients’ average lifespan is 17 months.”
The conversation turned a few heads in her office.
“My whole office stopped and stared. But then they clapped after they realized why I was yelling,” she tweeted later that night.
She continued: “@premera picked the wrong oncologist to mess with today. I will not be letting this go. This denial. Will. Not. Stand. An insurance company should not get to tell me how to practice medicine when Phase III RCT data and @NCCN + @ASCO guideline support my decision!”
A spokesperson for Premera said in a statement that, “while we did see many of the details about the case were posted to Twitter, we cannot comment on the specifics you noted due to privacy policies.”
The spokesperson explained that Premera has “the same goal as our provider partners: ensure our members have access to quality health care,” noting that prior authorization helps health plans evaluate the medical necessity and safety of health care services given that “15%-30% of care is unnecessary.”
“We also understand that providers may not agree with our decisions, which is why we have a robust appeals process,” the spokesperson said, suggesting Dr. Shatsky could have appealed the decision a second time.
And “if the member or provider still disagrees with Premera’s coverage decision after the initial appeal, providers can request review by a medical expert outside Premera who works for an independent review organization,” and the company “will pay for” and “abide by” that decision, the spokesperson added.
The Twitter storm
After Dr. Shatsky tweeted about her experience with Premera, she received a flood of support from the Twitterverse. The thread garnered tens of thousands of likes and hundreds of comments offering support and advice.
Several people suggested asking Merck for help accessing the drug. But Dr. Shatsky said no, “I’m tired of laying down and letting [insurance companies] win. It IS worth fighting for.”
The next morning, Dr. Shatsky got a call. It was the vice president of medical management at Premera.
“We’ve talked again, and we’ll give you the drug,” Dr. Shatsky recalled the Premera vice president saying.
The next day, Monday morning, Dr. Shatsky’s patient received her first infusion of pembrolizumab.
Although relieved, Dr. Shatsky noted that it wasn’t until she posted her experience to Twitter that Premera seemed to take notice.
Plus, “an oncologist without a strong social media following may not have gotten care approved and that’s not how medicine should work,” said Dr. Anderson, assistant professor in the department of clinical pharmacy, University of Colorado at Denver, Aurora.
Tatiana Prowell, MD, expressed similar concerns in a Nov. 20 tweet: “And sadly, the patients with cancer & an even busier, more exhausted doctor who doesn’t have a big [reach] on social media will be denied appropriate care. And that’s bank for insurers.”
But, Dr. Prowell noted sarcastically: “At least a patient with cancer had her care delayed & a dedicated OncTwitter colleague’s Physician Burnout was exacerbated.”
In this case, the prior authorization process took about a week – requiring an initial prior authorization request, an appeal after the request was denied, a peer-to-peer resulting in a second denial, and finally a tweet and a phone call from a top executive at the company.
In fact, these delays have become so common that Dr. Shatsky needs to anticipate and incorporate likely delays into her workflow.
“I learn which drugs will take a long time to get prior authorization for and then plan enough time so that my patient’s care is hopefully not delayed,” Dr. Shatsky said. “It should not be so hard to get appropriate and time-sensitive care for our patients.”
A version of this article first appeared on Medscape.com.
“Is this really the hill you want to die on?” asked Rebecca Shatsky, MD, a medical oncologist at the University of California, San Diego.
It was Nov. 18 and Dr. Shatsky was on the phone with a retired oncologist working for the health insurance company Premera Blue Cross.
Dr. Shatsky was appealing a prior authorization denial for pembrolizumab (Keytruda) to treat her patient with stage IIIc triple-negative breast cancer (TNBC). She hoped the peer-to-peer would reverse the denial. The Food and Drug Administration had approved the immunotherapy for people with high-risk TNBC both in the neoadjuvant setting alongside chemotherapy and, in her patient’s case, as a single-agent adjuvant treatment based on data from the KEYNOTE 522 trial.
In the peer-to-peer, Dr. Shatsky laid out the evidence, but she could tell the physician wasn’t going to budge.
When she pressed him further, asking why he was denying potentially lifesaving care for her patient, he said the data on whether patients really need adjuvant pembrolizumab were not clear yet.
“The man – who was not a breast oncologist – was essentially mansplaining breast oncology to me,” she said in an interview. “I don’t need a nonexpert giving me their misinterpretation of the data.”
Dr. Shatsky informed him that this decision would not stand. She would be escalating the claim.
“I’m not going to let you get in way of my patient’s survival,” Dr. Shatsky told the physician during the peer-to-peer. “We have one shot to cure this, and if we don’t do it now, patients’ average lifespan is 17 months.”
The conversation turned a few heads in her office.
“My whole office stopped and stared. But then they clapped after they realized why I was yelling,” she tweeted later that night.
She continued: “@premera picked the wrong oncologist to mess with today. I will not be letting this go. This denial. Will. Not. Stand. An insurance company should not get to tell me how to practice medicine when Phase III RCT data and @NCCN + @ASCO guideline support my decision!”
A spokesperson for Premera said in a statement that, “while we did see many of the details about the case were posted to Twitter, we cannot comment on the specifics you noted due to privacy policies.”
The spokesperson explained that Premera has “the same goal as our provider partners: ensure our members have access to quality health care,” noting that prior authorization helps health plans evaluate the medical necessity and safety of health care services given that “15%-30% of care is unnecessary.”
“We also understand that providers may not agree with our decisions, which is why we have a robust appeals process,” the spokesperson said, suggesting Dr. Shatsky could have appealed the decision a second time.
And “if the member or provider still disagrees with Premera’s coverage decision after the initial appeal, providers can request review by a medical expert outside Premera who works for an independent review organization,” and the company “will pay for” and “abide by” that decision, the spokesperson added.
The Twitter storm
After Dr. Shatsky tweeted about her experience with Premera, she received a flood of support from the Twitterverse. The thread garnered tens of thousands of likes and hundreds of comments offering support and advice.
Several people suggested asking Merck for help accessing the drug. But Dr. Shatsky said no, “I’m tired of laying down and letting [insurance companies] win. It IS worth fighting for.”
The next morning, Dr. Shatsky got a call. It was the vice president of medical management at Premera.
“We’ve talked again, and we’ll give you the drug,” Dr. Shatsky recalled the Premera vice president saying.
The next day, Monday morning, Dr. Shatsky’s patient received her first infusion of pembrolizumab.
Although relieved, Dr. Shatsky noted that it wasn’t until she posted her experience to Twitter that Premera seemed to take notice.
Plus, “an oncologist without a strong social media following may not have gotten care approved and that’s not how medicine should work,” said Dr. Anderson, assistant professor in the department of clinical pharmacy, University of Colorado at Denver, Aurora.
Tatiana Prowell, MD, expressed similar concerns in a Nov. 20 tweet: “And sadly, the patients with cancer & an even busier, more exhausted doctor who doesn’t have a big [reach] on social media will be denied appropriate care. And that’s bank for insurers.”
But, Dr. Prowell noted sarcastically: “At least a patient with cancer had her care delayed & a dedicated OncTwitter colleague’s Physician Burnout was exacerbated.”
In this case, the prior authorization process took about a week – requiring an initial prior authorization request, an appeal after the request was denied, a peer-to-peer resulting in a second denial, and finally a tweet and a phone call from a top executive at the company.
In fact, these delays have become so common that Dr. Shatsky needs to anticipate and incorporate likely delays into her workflow.
“I learn which drugs will take a long time to get prior authorization for and then plan enough time so that my patient’s care is hopefully not delayed,” Dr. Shatsky said. “It should not be so hard to get appropriate and time-sensitive care for our patients.”
A version of this article first appeared on Medscape.com.
“Is this really the hill you want to die on?” asked Rebecca Shatsky, MD, a medical oncologist at the University of California, San Diego.
It was Nov. 18 and Dr. Shatsky was on the phone with a retired oncologist working for the health insurance company Premera Blue Cross.
Dr. Shatsky was appealing a prior authorization denial for pembrolizumab (Keytruda) to treat her patient with stage IIIc triple-negative breast cancer (TNBC). She hoped the peer-to-peer would reverse the denial. The Food and Drug Administration had approved the immunotherapy for people with high-risk TNBC both in the neoadjuvant setting alongside chemotherapy and, in her patient’s case, as a single-agent adjuvant treatment based on data from the KEYNOTE 522 trial.
In the peer-to-peer, Dr. Shatsky laid out the evidence, but she could tell the physician wasn’t going to budge.
When she pressed him further, asking why he was denying potentially lifesaving care for her patient, he said the data on whether patients really need adjuvant pembrolizumab were not clear yet.
“The man – who was not a breast oncologist – was essentially mansplaining breast oncology to me,” she said in an interview. “I don’t need a nonexpert giving me their misinterpretation of the data.”
Dr. Shatsky informed him that this decision would not stand. She would be escalating the claim.
“I’m not going to let you get in way of my patient’s survival,” Dr. Shatsky told the physician during the peer-to-peer. “We have one shot to cure this, and if we don’t do it now, patients’ average lifespan is 17 months.”
The conversation turned a few heads in her office.
“My whole office stopped and stared. But then they clapped after they realized why I was yelling,” she tweeted later that night.
She continued: “@premera picked the wrong oncologist to mess with today. I will not be letting this go. This denial. Will. Not. Stand. An insurance company should not get to tell me how to practice medicine when Phase III RCT data and @NCCN + @ASCO guideline support my decision!”
A spokesperson for Premera said in a statement that, “while we did see many of the details about the case were posted to Twitter, we cannot comment on the specifics you noted due to privacy policies.”
The spokesperson explained that Premera has “the same goal as our provider partners: ensure our members have access to quality health care,” noting that prior authorization helps health plans evaluate the medical necessity and safety of health care services given that “15%-30% of care is unnecessary.”
“We also understand that providers may not agree with our decisions, which is why we have a robust appeals process,” the spokesperson said, suggesting Dr. Shatsky could have appealed the decision a second time.
And “if the member or provider still disagrees with Premera’s coverage decision after the initial appeal, providers can request review by a medical expert outside Premera who works for an independent review organization,” and the company “will pay for” and “abide by” that decision, the spokesperson added.
The Twitter storm
After Dr. Shatsky tweeted about her experience with Premera, she received a flood of support from the Twitterverse. The thread garnered tens of thousands of likes and hundreds of comments offering support and advice.
Several people suggested asking Merck for help accessing the drug. But Dr. Shatsky said no, “I’m tired of laying down and letting [insurance companies] win. It IS worth fighting for.”
The next morning, Dr. Shatsky got a call. It was the vice president of medical management at Premera.
“We’ve talked again, and we’ll give you the drug,” Dr. Shatsky recalled the Premera vice president saying.
The next day, Monday morning, Dr. Shatsky’s patient received her first infusion of pembrolizumab.
Although relieved, Dr. Shatsky noted that it wasn’t until she posted her experience to Twitter that Premera seemed to take notice.
Plus, “an oncologist without a strong social media following may not have gotten care approved and that’s not how medicine should work,” said Dr. Anderson, assistant professor in the department of clinical pharmacy, University of Colorado at Denver, Aurora.
Tatiana Prowell, MD, expressed similar concerns in a Nov. 20 tweet: “And sadly, the patients with cancer & an even busier, more exhausted doctor who doesn’t have a big [reach] on social media will be denied appropriate care. And that’s bank for insurers.”
But, Dr. Prowell noted sarcastically: “At least a patient with cancer had her care delayed & a dedicated OncTwitter colleague’s Physician Burnout was exacerbated.”
In this case, the prior authorization process took about a week – requiring an initial prior authorization request, an appeal after the request was denied, a peer-to-peer resulting in a second denial, and finally a tweet and a phone call from a top executive at the company.
In fact, these delays have become so common that Dr. Shatsky needs to anticipate and incorporate likely delays into her workflow.
“I learn which drugs will take a long time to get prior authorization for and then plan enough time so that my patient’s care is hopefully not delayed,” Dr. Shatsky said. “It should not be so hard to get appropriate and time-sensitive care for our patients.”
A version of this article first appeared on Medscape.com.
Should pediatricians fret over their falling board scores?
Few pediatricians have warm, fuzzy memories about taking their initial board exam.
But many reacted strongly when they read a recent post on Twitter by Bryan Carmody, MD, who noted that the passing rate for first-time test takers had dipped to its lowest level in 5 years – hitting 81% in 2021, down from 91% 3 years earlier.
“It’s literally an awfully written exam,” replied one person who posted. Another asked: “At what point is the exam just not reflective of clinical practice?” And, inevitably, the question of the effect of COVID-19 surfaced: “Is any of this attributable to pulling early career physicians into the pandemic?”
But Dr. Carmody, an associate professor of pediatrics at the University of Eastern Virginia Medical School, Norfolk, isn’t buying that explanation. He researched board scores for internal medicine, general surgery, and family medicine for 2021. All were stable during the same period, he said, leading him to dismiss the idea that the pandemic drove the decline. “It’s not really clear to me why other specialties wouldn’t have seen similar drops,” Dr. Carmody said.
The slip has caught the attention of the American Board of Pediatrics, according to Judy Schaechter, MD, MBA, who was chair of the department of pediatrics at the University of Miami before taking her post as president and CEO of the American Board of Pediatrics in 2021.
“So, our first question was, was this within the range of what one might expect?” Dr. Schaechter said. “Were there other factors that might have come into play?”
The board performs an extensive analysis every year before releasing scores, and it didn’t uncover any changes in the difficulty or content of the test in 2021, nor did the score that was needed to pass increase. Dr. Schaechter pointed out that the passing rate that year was not unprecedented – in 2016, it also dipped to 81%.
Dr. Schaechter said COVID-19 might have affected test takers. “Remember, pediatrics was different from any other specialty during the pandemic,” she said. The census in pediatric wards around the country dropped dramatically in the first two winters of the pandemic, leaving residents with less hands-on experience with patients and mentorship from attendings – both of which can help test-takers pass the exam.
Eyal Ben-Isaac, MD, an associate professor of the department of pediatrics at the Keck School of Medicine at the University of Southern California, Los Angeles, said residents likely suffered during the pandemic, when noon lectures and grand rounds became virtual events.
“I’m sure that clearly affected a person’s ability to sit and listen and really learn the material, as opposed to either doing it hands on or learning the material from a faculty member face to face,” Dr. Ben-Isaac said.
But how much do the didactic experiences of residency programs contribute to residents’ readiness to take the boards? Thomas Welch, MD, professor and chair emeritus of the department of pediatrics at SUNY Upstate Medical University, Syracuse, credits his own success in advancing through college, medical school, pediatric residency, and nephrology fellowship to his skill as a test taker.
He confirmed his suspicions by conducting a study that evaluated correlations between residents’ performance on the United States Medical Licensing Exam (USMLE) taken during medical school and their board scores after completing residency.
Dr. Welch said he wasn’t surprised to find that “the best predictor of one’s passing the pediatric boards was not the training program in which one worked. It was their performance on Step 2 [taken during the fourth year of medical school] of the USMLE.”
Although Dr. Ben-Isaac felt that changes in residency training opportunities might have partially explained the drop in passing rates, he agreed that other factors contribute to success on boards. As director of the pediatric residency program at Children’s Hospital of Los Angeles from 1994 to 2019, one of his first goals was to increase the pass rate of graduates. He developed a board review course for residents, revising it over time on the basis of resident feedback and adding individual coaching for residents who wanted more help.
“Without a question, it raised our board pass rate to being one of the highest in the country,” he said.
Dr. Welch said that while “being up all night with a sick child teaches you a lot about medicine and certainly makes you a better doctor, it doesn’t do anything to improve your board scores.”
None of the pediatricians was too worried about a 1-year drop in scores, and the consensus was that supporting residents with review courses and coaching on how to take multiple choice tests would raise passing rates.
“There are definitely people who are amazing clinicians who did not pass the boards on their first attempt,” Dr. Ben-Isaac said.
But Dr. Schaechter defended the importance of the examination. “Our first obligation is really to the public,” she said. The ABP’s role is to ensure that pediatricians “provide the care that parents want their kids to have.”
As Dr. Welch put it, “Would I trust someone who didn’t pass the board exam to take care of my own kid? Probably not.”
A version of this article first appeared on Medscape.com.
Few pediatricians have warm, fuzzy memories about taking their initial board exam.
But many reacted strongly when they read a recent post on Twitter by Bryan Carmody, MD, who noted that the passing rate for first-time test takers had dipped to its lowest level in 5 years – hitting 81% in 2021, down from 91% 3 years earlier.
“It’s literally an awfully written exam,” replied one person who posted. Another asked: “At what point is the exam just not reflective of clinical practice?” And, inevitably, the question of the effect of COVID-19 surfaced: “Is any of this attributable to pulling early career physicians into the pandemic?”
But Dr. Carmody, an associate professor of pediatrics at the University of Eastern Virginia Medical School, Norfolk, isn’t buying that explanation. He researched board scores for internal medicine, general surgery, and family medicine for 2021. All were stable during the same period, he said, leading him to dismiss the idea that the pandemic drove the decline. “It’s not really clear to me why other specialties wouldn’t have seen similar drops,” Dr. Carmody said.
The slip has caught the attention of the American Board of Pediatrics, according to Judy Schaechter, MD, MBA, who was chair of the department of pediatrics at the University of Miami before taking her post as president and CEO of the American Board of Pediatrics in 2021.
“So, our first question was, was this within the range of what one might expect?” Dr. Schaechter said. “Were there other factors that might have come into play?”
The board performs an extensive analysis every year before releasing scores, and it didn’t uncover any changes in the difficulty or content of the test in 2021, nor did the score that was needed to pass increase. Dr. Schaechter pointed out that the passing rate that year was not unprecedented – in 2016, it also dipped to 81%.
Dr. Schaechter said COVID-19 might have affected test takers. “Remember, pediatrics was different from any other specialty during the pandemic,” she said. The census in pediatric wards around the country dropped dramatically in the first two winters of the pandemic, leaving residents with less hands-on experience with patients and mentorship from attendings – both of which can help test-takers pass the exam.
Eyal Ben-Isaac, MD, an associate professor of the department of pediatrics at the Keck School of Medicine at the University of Southern California, Los Angeles, said residents likely suffered during the pandemic, when noon lectures and grand rounds became virtual events.
“I’m sure that clearly affected a person’s ability to sit and listen and really learn the material, as opposed to either doing it hands on or learning the material from a faculty member face to face,” Dr. Ben-Isaac said.
But how much do the didactic experiences of residency programs contribute to residents’ readiness to take the boards? Thomas Welch, MD, professor and chair emeritus of the department of pediatrics at SUNY Upstate Medical University, Syracuse, credits his own success in advancing through college, medical school, pediatric residency, and nephrology fellowship to his skill as a test taker.
He confirmed his suspicions by conducting a study that evaluated correlations between residents’ performance on the United States Medical Licensing Exam (USMLE) taken during medical school and their board scores after completing residency.
Dr. Welch said he wasn’t surprised to find that “the best predictor of one’s passing the pediatric boards was not the training program in which one worked. It was their performance on Step 2 [taken during the fourth year of medical school] of the USMLE.”
Although Dr. Ben-Isaac felt that changes in residency training opportunities might have partially explained the drop in passing rates, he agreed that other factors contribute to success on boards. As director of the pediatric residency program at Children’s Hospital of Los Angeles from 1994 to 2019, one of his first goals was to increase the pass rate of graduates. He developed a board review course for residents, revising it over time on the basis of resident feedback and adding individual coaching for residents who wanted more help.
“Without a question, it raised our board pass rate to being one of the highest in the country,” he said.
Dr. Welch said that while “being up all night with a sick child teaches you a lot about medicine and certainly makes you a better doctor, it doesn’t do anything to improve your board scores.”
None of the pediatricians was too worried about a 1-year drop in scores, and the consensus was that supporting residents with review courses and coaching on how to take multiple choice tests would raise passing rates.
“There are definitely people who are amazing clinicians who did not pass the boards on their first attempt,” Dr. Ben-Isaac said.
But Dr. Schaechter defended the importance of the examination. “Our first obligation is really to the public,” she said. The ABP’s role is to ensure that pediatricians “provide the care that parents want their kids to have.”
As Dr. Welch put it, “Would I trust someone who didn’t pass the board exam to take care of my own kid? Probably not.”
A version of this article first appeared on Medscape.com.
Few pediatricians have warm, fuzzy memories about taking their initial board exam.
But many reacted strongly when they read a recent post on Twitter by Bryan Carmody, MD, who noted that the passing rate for first-time test takers had dipped to its lowest level in 5 years – hitting 81% in 2021, down from 91% 3 years earlier.
“It’s literally an awfully written exam,” replied one person who posted. Another asked: “At what point is the exam just not reflective of clinical practice?” And, inevitably, the question of the effect of COVID-19 surfaced: “Is any of this attributable to pulling early career physicians into the pandemic?”
But Dr. Carmody, an associate professor of pediatrics at the University of Eastern Virginia Medical School, Norfolk, isn’t buying that explanation. He researched board scores for internal medicine, general surgery, and family medicine for 2021. All were stable during the same period, he said, leading him to dismiss the idea that the pandemic drove the decline. “It’s not really clear to me why other specialties wouldn’t have seen similar drops,” Dr. Carmody said.
The slip has caught the attention of the American Board of Pediatrics, according to Judy Schaechter, MD, MBA, who was chair of the department of pediatrics at the University of Miami before taking her post as president and CEO of the American Board of Pediatrics in 2021.
“So, our first question was, was this within the range of what one might expect?” Dr. Schaechter said. “Were there other factors that might have come into play?”
The board performs an extensive analysis every year before releasing scores, and it didn’t uncover any changes in the difficulty or content of the test in 2021, nor did the score that was needed to pass increase. Dr. Schaechter pointed out that the passing rate that year was not unprecedented – in 2016, it also dipped to 81%.
Dr. Schaechter said COVID-19 might have affected test takers. “Remember, pediatrics was different from any other specialty during the pandemic,” she said. The census in pediatric wards around the country dropped dramatically in the first two winters of the pandemic, leaving residents with less hands-on experience with patients and mentorship from attendings – both of which can help test-takers pass the exam.
Eyal Ben-Isaac, MD, an associate professor of the department of pediatrics at the Keck School of Medicine at the University of Southern California, Los Angeles, said residents likely suffered during the pandemic, when noon lectures and grand rounds became virtual events.
“I’m sure that clearly affected a person’s ability to sit and listen and really learn the material, as opposed to either doing it hands on or learning the material from a faculty member face to face,” Dr. Ben-Isaac said.
But how much do the didactic experiences of residency programs contribute to residents’ readiness to take the boards? Thomas Welch, MD, professor and chair emeritus of the department of pediatrics at SUNY Upstate Medical University, Syracuse, credits his own success in advancing through college, medical school, pediatric residency, and nephrology fellowship to his skill as a test taker.
He confirmed his suspicions by conducting a study that evaluated correlations between residents’ performance on the United States Medical Licensing Exam (USMLE) taken during medical school and their board scores after completing residency.
Dr. Welch said he wasn’t surprised to find that “the best predictor of one’s passing the pediatric boards was not the training program in which one worked. It was their performance on Step 2 [taken during the fourth year of medical school] of the USMLE.”
Although Dr. Ben-Isaac felt that changes in residency training opportunities might have partially explained the drop in passing rates, he agreed that other factors contribute to success on boards. As director of the pediatric residency program at Children’s Hospital of Los Angeles from 1994 to 2019, one of his first goals was to increase the pass rate of graduates. He developed a board review course for residents, revising it over time on the basis of resident feedback and adding individual coaching for residents who wanted more help.
“Without a question, it raised our board pass rate to being one of the highest in the country,” he said.
Dr. Welch said that while “being up all night with a sick child teaches you a lot about medicine and certainly makes you a better doctor, it doesn’t do anything to improve your board scores.”
None of the pediatricians was too worried about a 1-year drop in scores, and the consensus was that supporting residents with review courses and coaching on how to take multiple choice tests would raise passing rates.
“There are definitely people who are amazing clinicians who did not pass the boards on their first attempt,” Dr. Ben-Isaac said.
But Dr. Schaechter defended the importance of the examination. “Our first obligation is really to the public,” she said. The ABP’s role is to ensure that pediatricians “provide the care that parents want their kids to have.”
As Dr. Welch put it, “Would I trust someone who didn’t pass the board exam to take care of my own kid? Probably not.”
A version of this article first appeared on Medscape.com.
Teamwork guides cardio-rheumatology clinics that care for unique patient population
Clinical cardiologist Heba Wassif, MD, MPH, knows the value of working with her fellow rheumatologists, surgeons, and other clinicians to establish a care plan for her patients with cardiac conditions and autoimmune diseases.
She is the cofounder of the Cleveland Clinic’s new cardio-rheumatology program, which places an emphasis on multidisciplinary care. In her role, Dr. Wassif closely follows her patients, and if she sees any inflammation or any other condition that requires the rheumatologist, she reaches out to her colleagues to adjust medications if needed.
Collaboration with a rheumatologist was important when a patient with valvular disease was prepping for surgery. The patient was on significant immunosuppressants and the surgery had to be timed appropriately, accounting for any decreases in her immunosuppression, explained Dr. Wassif, director of inpatient clinical cardiology at Cleveland Clinic in Ohio.
Cardio-rheumatology programs are “the newest child” in a series of cardiology offshoots focusing on different populations. Cardio-oncology and cardio-obstetrics took off about 6 years ago, with cardio-rheumatology clinics and interested physicians rising in number over the last several years, Dr. Wassif noted.
The relationship between cardiovascular diseases and rheumatologic conditions is certainly recognized more often, “which means more literature is being published to discuss the link,” according to Rekha Mankad, MD, a trailblazer of this model of care. She directs the Women’s Heart Clinic at Mayo Clinic in Rochester, Minn., which was one of the earliest adopters of a cardio-rheumatology clinic.
Ten years ago, “nobody was talking about the link between rheumatologic conditions and cardiovascular disease,” Dr. Mankad said. “I’ve been asked to speak on this topic, and programs have asked me to speak about establishing cardio-rheumatology practices. So, there’s been an evolution as far as a recognition that these two conditions overlap.”
Patients have come to her independent of internal referrals, which means they have done Google searches on cardiology and rheumatology. “I think that it has made a splash, at least in the world of cardiology,” Dr. Mankad observed in an interview.
Other institutions such as NYU-Langone, Yale, Stanford, Brigham and Women’s Hospital in Boston, and Women’s College Hospital in Toronto have formed similar clinics whose focus is to address the specific needs of rheumatology patients with cardiac conditions through a teamwork approach.
Challenges of treating cardiac, rheumatologic conditions
The rise in clinics addresses the longstanding connection between autoimmune disorders and cardiac conditions.
Cardiologists have known that there is an element of inflammation that contributes to atherosclerosis, said Dr. Wassif, who has researched this topic extensively. A recent study she led found a strong association between rheumatic immune-mediated inflammatory diseases (IMIDs) and high risk of acute coronary syndrome in Medicare patients.
“This particular population has a very clear increased risk for cardiovascular conditions, including valve disease and heart failure,” she emphasized.
Patients with rheumatoid arthritis and lupus have up to a twofold and eightfold higher risk of heart disease, respectively, noted Michael S. Garshick, MD, a cardiovascular disease specialist who directs the cardio-rheumatology program at NYU-Langone Health, in New York. Cardiologists “have really developed an understanding that the immune system can impact the heart, and that there’s a need for people to understand the nuance behind how the immune system can affect them and what to do about it,” Dr. Garshick said.
Caring for patients with both afflictions comes with specific challenges. Many physicians are not well trained on managing and treating patients with these dual conditions.
The “lipid paradox,” in which lipids are reduced with active inflammation in some rheumatologic conditions, can make treatment more nuanced. In addition, the traditional ASCVD (atherosclerotic cardiovascular disease) score often underestimates the cardiovascular risk of these patients, noted cardiologist Margaret Furman, MD, MPH, assistant professor and codirector of Yale’s Cardio-Rheumatology Program, New Haven, Conn.
Newer biologic medications used to treat rheumatologic diseases can alter a patient’s lipid profile, she said in an interview.
“It can be difficult to assess each individual patient’s cardiovascular risk as their disease state and treatment can vary throughout their lifetime based on their degree of inflammation. The importance of aggressive lipid management is often underestimated,” Dr. Furman added.
Cardiology and rheumatology partnerships can address gaps in care of this unique group of patients, said Vaidehi R. Chowdhary, MBBS, MD, clinical chief of the Yale Section of Rheumatology, Allergy, and Immunology at Yale University.
“The role of the rheumatologist in this dyad is to educate patients on this risk, work toward adequate control of inflammation, and minimize use of medications that contribute to increased cardiovascular risks,” said Dr. Chowdhary, who cofounded Yale’s cardio-rheumatology program with Dr. Furman.
Cardiologists in turn can assert their knowledge about medications and their impact on lipids and inflammation, Dr. Wassif said.
Many anti-inflammatory therapies are now within the cardiologist’s purview, Dr. Garshick noted. “For example, specifically with pericarditis, there’s [Food and Drug Administration]–approved anti-inflammatories or biologics. We’re the ones who feel the most comfortable giving them right now.” Cardiologists quite often are consulted about medications that are efficacious in rheumatologic conditions but could negatively impact the cardiovascular system, such as Janus kinase inhibitors, he added.
‘Reading the tea leaves’
Each program has its own unique story. For the Cleveland Clinic, the concept of a cardio-rheumatology program began during the COVID-19 pandemic in 2020. Developing such a concept and gaining institutional acceptance is always a work in process, Dr. Wassif said. “It’s not that you decide one day that you’re going to build a center, and that center is going to come into fruition overnight. You first gauge interest within your division. Who are the individuals that are interested in this area?”
Cleveland Clinic’s center is seeking to build relations between medical disciplines while spotlighting the concept of cardio-rheumatology, said Dr. Wassif, who has been providing education within the clinic and at other health institutions to ensure that patients receive appropriate attention early.
NYU-Langone launched its program amid this heightened awareness that the immune system could affect atherosclerosis, “kind of reading of the tea leaves, so to speak,” Dr. Garshick said.
Several clinical trials served as a catalyst for this movement. “A lot of clinical cardiologists were never 100% convinced that targeting the immune system reduced cardiovascular disease,” he said. Then the CANTOS clinical trial came along and showed for the first time that a therapeutic monoclonal antibody targeting interleukin-1beta, a cytokine central to inflammatory response, could in fact reduce cardiovascular disease.
Trials like this, along with epidemiologic literature connecting the rheumatologic and the autoimmune conditions with cardiovascular disease, pushed this concept to the forefront, Dr. Garshick said.
The notion that a clinic could successfully address cardiac problems in patients with rheumatic diseases yielded promising returns at Women’s College Hospital in Toronto, according to a report presented at the 2018 American College of Rheumatology annual meeting. Researchers reported that patients with rheumatologic conditions who attended a cardio-rheumatology clinic at this center saw improvements in care. The clinic identified increased cardiovascular risk and early atherosclerosis, and 53.8% of patients altered their medications after being seen in the clinic.
A total of 39.7% and 32.1% received lipid lowering and antiplatelet therapies, respectively, and 14% received antihypertensive therapy. A small percentage were treated for heart failure or placed on lifelong anticoagulation therapy for atrial fibrillation, and one patient received a percutaneous coronary stent.
Ins and outs of the referral process
Initially designed for preventive cardiac risk assessment, Yale’s program evolved into a multidisciplinary, patient-centered approach for the management of complex cardiovascular conditions in patients with autoimmune rheumatologic diseases.
The program is open to anyone who carries a diagnosis of rheumatologic disease or has elevated inflammatory markers. “Every patient, regardless of the reason for the referral, receives a cardiovascular risk assessment,” Dr. Furman said.
Most referrals come from rheumatologists, although cardiology colleagues and pulmonologists have also sent referrals. A pulmonologist, for example, may want to rule out a cardiac cause to shortness of breath. The patient’s workup, care, and follow-up are based on the reason for referral.
“We are currently referring patients with established cardiac disease, traditional risk factors, or for better risk assessment for primary prevention of coronary artery disease,” Dr. Chowdhary said. “We communicate very frequently about medication changes, and patients are aware of goals of care from both sides.”
Dr. Furman works closely with several of the rheumatology specialists taking care of patients with rheumatoid arthritis, systemic lupus erythematosus, and scleroderma.
Rheumatology follows patients every 3-6 months or more frequently based on their disease activity.
Dr. Mankad uses her sleuthing skills at Mayo Clinic to determine what the patients need. If they come in for a preventive assessment, she looks more closely at their cardiovascular risks and may order additional imaging to look for subclinical atherosclerosis. “We’re more aggressive with statin therapy in this population because of that,” she said.
If it’s valve disease, she pays extra attention to the patients’ valves in the echocardiograms and follows them a bit more regularly than someone without a rheumatologic condition and valve disease.
For patients with heart failure signs or symptoms, “it depends on how symptomatic they are,” Dr. Mankad said. In some instances, she may look for evidence of heart failure with preserved ejection fraction in patients who have rheumatoid arthritis who happen to be short of breath. “There’s so many different manifestations that patients with rheumatologic conditions can have as far as what could be affected in the heart,” she noted.
Quite frequently, Dr. Mankad identifies subclinical disease in her patients with rheumatoid arthritis. “I’ve seen many patients whose risk scores would not dictate statin therapy. But I went looking for subclinical disease by either doing coronary assessment or carotid assessment and have found atherosclerosis that would be enough to warrant statin therapy.”
A personalized assessment to reduce cardiac risk
NYU-Langone’s program offers opportunities to educate patients about the link between cardiac and rheumatologic disease.
“Their rheumatologist or their dermatologist will say, ‘Hey, have you heard about the connection between psoriasis, psoriatic or rheumatoid arthritis, and heart disease and the risk of heart attack or stroke?’ ” Dr. Garshick said.
The patients will often say they know nothing about these connections and want to learn more about how to treat it.
“We’ll say, ‘we have someone here that can help you.’ They’ll send them to myself or other colleagues like me across the country. We’ll assess blood pressure, weight, lipids, hemoglobin A1c, and other serologic and oftentimes imaging biomarkers of cardiovascular risk.” The patients will receive a personalized assessment, listing things they can do to lower their risk, whether it’s diet, exercise, or lifestyle. “Many times it can involve medications to reduce heart disease risk,” said Dr. Garshick.
In some instances, a rheumatologist or dermatologist may be concerned about starting a patient on a specific medication for the disease such as a JAK inhibitor. “We’ll help assess their risk because there’s been a lot of literature out in the rheumatology world about the risk of JAK inhibitors and heart disease and blood clots,” said Dr. Garshick.
Dr. Garshick also sees patients with rheumatologic conditions who have a specific cardiovascular concern or complaint such as shortness of breath or chest pain. “We’ll work that up with a specific knowledge of the underlying immune condition and how that may impact their heart,” he said.
Advances in research
As they continue to see patients and devise specific care plans, developers of cardio-rheumatology programs have been supplementing their work with ongoing research.
Yale’s clinic is expanding this year to include a new attending physician, Attila Feher, MD, PhD, who has conducted research in autoimmunity and microcirculation using molecular imaging and multimodality imaging techniques. Prevalence of coronary microvascular dysfunction appears to be increased in this patient population, Dr. Furman said.
Dr. Wassif recently coauthored a paper that examined patients with underlying rheumatologic conditions who undergo valvular and aortic valve replacement. “To our surprise, there was really no difference between patients with autoimmune conditions and others with nonautoimmune conditions,” she said, adding that the study had its limitations.
Other work includes data on Medicare patients with ST- and non-ST-elevation myocardial infarctions who have an underlying autoimmune disorder. Dr. Wassif and her colleagues found that their long-term outcomes are worse than those of patients without these conditions. “It’s unclear if worse outcomes are related to complications of autoimmunity versus the extent of their underlying disease. This is a work in progress and certainly an area that is ripe for research.”
Dr. Garshick and other collaborators at NYU have been focusing on the endothelium, specifically platelet biology in patients with psoriasis, psoriatic arthritis, and lupus. “We’re about to start the same research with gout as well,” he said.
“The process we’re most interested in is understanding how these diseases impact the early stages of cholesterol. And the way we’re doing that is evaluating the vasculature, specifically the endothelium,” he said.
He has finished two clinical trials that evaluate how standard heart disease medications such as aspirin and statins impact or can potentially benefit patients with psoriasis and/or psoriatic arthritis. “We have a whole list of other trials in the pipeline with other institutions across the country.”
Through a grant, Dr. Mankad is assessing whether a PET scan could detect inflammation in the hearts of rheumatoid arthritis patients. “We’re looking to see if the reason these patients have heart failure later in life is because their heart muscle actually shows evidence of inflammation, even when they have no symptoms,” she explained.
Other tests such as echocardiogram and CT scans will be used to evaluate coronary disease in about 40-50 patients. The goal of using these multiple imaging tools is to find markers indicating that the heart is affected by rheumatoid arthritis, which may indicate a higher likelihood of developing heart failure, she said.
Clinics are popping up
Through these new clinics, some collaborations have emerged. Dr. Garshick works closely with Brigham and Women’s Hospital, which has a similar cardio-rheumatology program, run by Brittany Weber, MD, to exchange ideas, discuss challenging cases, and collaborate.
“There are a lot of clinics like us popping up across the country,” he observed. Every so often, he hears from other institutions that are interested in starting their own cardio-rheumatology programs. “They ask us: How do you start, what should we look for?”
It’s an education process for both patients and providers, Dr. Garshick emphasized. “I also think it’s a bandwidth issue. Many of our rheumatology and dermatology colleagues are acutely aware of the connection, but there may not be enough time at a clinic visit to really go in depth” with these dual conditions, he said.
NYU-Langone Health for the past several years has been holding a symposium to educate people on the cardio-rheumatology connection and treating inflammation in cardiovascular disease. This year’s symposium, held in conjunction with Brigham and Women’s Hospital, is scheduled for April 28. For more information, visit the course website: nyulmc.org/cvinflammationcme.
“What we’re trying to do is help [other institutions] get that bandwidth” to adequately help and serve these patients, he said.
Dr. Garshick has received consultant fees from Abbvie and Horizon therapeutics and an unrestricted research grant from Pfizer. No other sources had relevant financial disclosures.
Clinical cardiologist Heba Wassif, MD, MPH, knows the value of working with her fellow rheumatologists, surgeons, and other clinicians to establish a care plan for her patients with cardiac conditions and autoimmune diseases.
She is the cofounder of the Cleveland Clinic’s new cardio-rheumatology program, which places an emphasis on multidisciplinary care. In her role, Dr. Wassif closely follows her patients, and if she sees any inflammation or any other condition that requires the rheumatologist, she reaches out to her colleagues to adjust medications if needed.
Collaboration with a rheumatologist was important when a patient with valvular disease was prepping for surgery. The patient was on significant immunosuppressants and the surgery had to be timed appropriately, accounting for any decreases in her immunosuppression, explained Dr. Wassif, director of inpatient clinical cardiology at Cleveland Clinic in Ohio.
Cardio-rheumatology programs are “the newest child” in a series of cardiology offshoots focusing on different populations. Cardio-oncology and cardio-obstetrics took off about 6 years ago, with cardio-rheumatology clinics and interested physicians rising in number over the last several years, Dr. Wassif noted.
The relationship between cardiovascular diseases and rheumatologic conditions is certainly recognized more often, “which means more literature is being published to discuss the link,” according to Rekha Mankad, MD, a trailblazer of this model of care. She directs the Women’s Heart Clinic at Mayo Clinic in Rochester, Minn., which was one of the earliest adopters of a cardio-rheumatology clinic.
Ten years ago, “nobody was talking about the link between rheumatologic conditions and cardiovascular disease,” Dr. Mankad said. “I’ve been asked to speak on this topic, and programs have asked me to speak about establishing cardio-rheumatology practices. So, there’s been an evolution as far as a recognition that these two conditions overlap.”
Patients have come to her independent of internal referrals, which means they have done Google searches on cardiology and rheumatology. “I think that it has made a splash, at least in the world of cardiology,” Dr. Mankad observed in an interview.
Other institutions such as NYU-Langone, Yale, Stanford, Brigham and Women’s Hospital in Boston, and Women’s College Hospital in Toronto have formed similar clinics whose focus is to address the specific needs of rheumatology patients with cardiac conditions through a teamwork approach.
Challenges of treating cardiac, rheumatologic conditions
The rise in clinics addresses the longstanding connection between autoimmune disorders and cardiac conditions.
Cardiologists have known that there is an element of inflammation that contributes to atherosclerosis, said Dr. Wassif, who has researched this topic extensively. A recent study she led found a strong association between rheumatic immune-mediated inflammatory diseases (IMIDs) and high risk of acute coronary syndrome in Medicare patients.
“This particular population has a very clear increased risk for cardiovascular conditions, including valve disease and heart failure,” she emphasized.
Patients with rheumatoid arthritis and lupus have up to a twofold and eightfold higher risk of heart disease, respectively, noted Michael S. Garshick, MD, a cardiovascular disease specialist who directs the cardio-rheumatology program at NYU-Langone Health, in New York. Cardiologists “have really developed an understanding that the immune system can impact the heart, and that there’s a need for people to understand the nuance behind how the immune system can affect them and what to do about it,” Dr. Garshick said.
Caring for patients with both afflictions comes with specific challenges. Many physicians are not well trained on managing and treating patients with these dual conditions.
The “lipid paradox,” in which lipids are reduced with active inflammation in some rheumatologic conditions, can make treatment more nuanced. In addition, the traditional ASCVD (atherosclerotic cardiovascular disease) score often underestimates the cardiovascular risk of these patients, noted cardiologist Margaret Furman, MD, MPH, assistant professor and codirector of Yale’s Cardio-Rheumatology Program, New Haven, Conn.
Newer biologic medications used to treat rheumatologic diseases can alter a patient’s lipid profile, she said in an interview.
“It can be difficult to assess each individual patient’s cardiovascular risk as their disease state and treatment can vary throughout their lifetime based on their degree of inflammation. The importance of aggressive lipid management is often underestimated,” Dr. Furman added.
Cardiology and rheumatology partnerships can address gaps in care of this unique group of patients, said Vaidehi R. Chowdhary, MBBS, MD, clinical chief of the Yale Section of Rheumatology, Allergy, and Immunology at Yale University.
“The role of the rheumatologist in this dyad is to educate patients on this risk, work toward adequate control of inflammation, and minimize use of medications that contribute to increased cardiovascular risks,” said Dr. Chowdhary, who cofounded Yale’s cardio-rheumatology program with Dr. Furman.
Cardiologists in turn can assert their knowledge about medications and their impact on lipids and inflammation, Dr. Wassif said.
Many anti-inflammatory therapies are now within the cardiologist’s purview, Dr. Garshick noted. “For example, specifically with pericarditis, there’s [Food and Drug Administration]–approved anti-inflammatories or biologics. We’re the ones who feel the most comfortable giving them right now.” Cardiologists quite often are consulted about medications that are efficacious in rheumatologic conditions but could negatively impact the cardiovascular system, such as Janus kinase inhibitors, he added.
‘Reading the tea leaves’
Each program has its own unique story. For the Cleveland Clinic, the concept of a cardio-rheumatology program began during the COVID-19 pandemic in 2020. Developing such a concept and gaining institutional acceptance is always a work in process, Dr. Wassif said. “It’s not that you decide one day that you’re going to build a center, and that center is going to come into fruition overnight. You first gauge interest within your division. Who are the individuals that are interested in this area?”
Cleveland Clinic’s center is seeking to build relations between medical disciplines while spotlighting the concept of cardio-rheumatology, said Dr. Wassif, who has been providing education within the clinic and at other health institutions to ensure that patients receive appropriate attention early.
NYU-Langone launched its program amid this heightened awareness that the immune system could affect atherosclerosis, “kind of reading of the tea leaves, so to speak,” Dr. Garshick said.
Several clinical trials served as a catalyst for this movement. “A lot of clinical cardiologists were never 100% convinced that targeting the immune system reduced cardiovascular disease,” he said. Then the CANTOS clinical trial came along and showed for the first time that a therapeutic monoclonal antibody targeting interleukin-1beta, a cytokine central to inflammatory response, could in fact reduce cardiovascular disease.
Trials like this, along with epidemiologic literature connecting the rheumatologic and the autoimmune conditions with cardiovascular disease, pushed this concept to the forefront, Dr. Garshick said.
The notion that a clinic could successfully address cardiac problems in patients with rheumatic diseases yielded promising returns at Women’s College Hospital in Toronto, according to a report presented at the 2018 American College of Rheumatology annual meeting. Researchers reported that patients with rheumatologic conditions who attended a cardio-rheumatology clinic at this center saw improvements in care. The clinic identified increased cardiovascular risk and early atherosclerosis, and 53.8% of patients altered their medications after being seen in the clinic.
A total of 39.7% and 32.1% received lipid lowering and antiplatelet therapies, respectively, and 14% received antihypertensive therapy. A small percentage were treated for heart failure or placed on lifelong anticoagulation therapy for atrial fibrillation, and one patient received a percutaneous coronary stent.
Ins and outs of the referral process
Initially designed for preventive cardiac risk assessment, Yale’s program evolved into a multidisciplinary, patient-centered approach for the management of complex cardiovascular conditions in patients with autoimmune rheumatologic diseases.
The program is open to anyone who carries a diagnosis of rheumatologic disease or has elevated inflammatory markers. “Every patient, regardless of the reason for the referral, receives a cardiovascular risk assessment,” Dr. Furman said.
Most referrals come from rheumatologists, although cardiology colleagues and pulmonologists have also sent referrals. A pulmonologist, for example, may want to rule out a cardiac cause to shortness of breath. The patient’s workup, care, and follow-up are based on the reason for referral.
“We are currently referring patients with established cardiac disease, traditional risk factors, or for better risk assessment for primary prevention of coronary artery disease,” Dr. Chowdhary said. “We communicate very frequently about medication changes, and patients are aware of goals of care from both sides.”
Dr. Furman works closely with several of the rheumatology specialists taking care of patients with rheumatoid arthritis, systemic lupus erythematosus, and scleroderma.
Rheumatology follows patients every 3-6 months or more frequently based on their disease activity.
Dr. Mankad uses her sleuthing skills at Mayo Clinic to determine what the patients need. If they come in for a preventive assessment, she looks more closely at their cardiovascular risks and may order additional imaging to look for subclinical atherosclerosis. “We’re more aggressive with statin therapy in this population because of that,” she said.
If it’s valve disease, she pays extra attention to the patients’ valves in the echocardiograms and follows them a bit more regularly than someone without a rheumatologic condition and valve disease.
For patients with heart failure signs or symptoms, “it depends on how symptomatic they are,” Dr. Mankad said. In some instances, she may look for evidence of heart failure with preserved ejection fraction in patients who have rheumatoid arthritis who happen to be short of breath. “There’s so many different manifestations that patients with rheumatologic conditions can have as far as what could be affected in the heart,” she noted.
Quite frequently, Dr. Mankad identifies subclinical disease in her patients with rheumatoid arthritis. “I’ve seen many patients whose risk scores would not dictate statin therapy. But I went looking for subclinical disease by either doing coronary assessment or carotid assessment and have found atherosclerosis that would be enough to warrant statin therapy.”
A personalized assessment to reduce cardiac risk
NYU-Langone’s program offers opportunities to educate patients about the link between cardiac and rheumatologic disease.
“Their rheumatologist or their dermatologist will say, ‘Hey, have you heard about the connection between psoriasis, psoriatic or rheumatoid arthritis, and heart disease and the risk of heart attack or stroke?’ ” Dr. Garshick said.
The patients will often say they know nothing about these connections and want to learn more about how to treat it.
“We’ll say, ‘we have someone here that can help you.’ They’ll send them to myself or other colleagues like me across the country. We’ll assess blood pressure, weight, lipids, hemoglobin A1c, and other serologic and oftentimes imaging biomarkers of cardiovascular risk.” The patients will receive a personalized assessment, listing things they can do to lower their risk, whether it’s diet, exercise, or lifestyle. “Many times it can involve medications to reduce heart disease risk,” said Dr. Garshick.
In some instances, a rheumatologist or dermatologist may be concerned about starting a patient on a specific medication for the disease such as a JAK inhibitor. “We’ll help assess their risk because there’s been a lot of literature out in the rheumatology world about the risk of JAK inhibitors and heart disease and blood clots,” said Dr. Garshick.
Dr. Garshick also sees patients with rheumatologic conditions who have a specific cardiovascular concern or complaint such as shortness of breath or chest pain. “We’ll work that up with a specific knowledge of the underlying immune condition and how that may impact their heart,” he said.
Advances in research
As they continue to see patients and devise specific care plans, developers of cardio-rheumatology programs have been supplementing their work with ongoing research.
Yale’s clinic is expanding this year to include a new attending physician, Attila Feher, MD, PhD, who has conducted research in autoimmunity and microcirculation using molecular imaging and multimodality imaging techniques. Prevalence of coronary microvascular dysfunction appears to be increased in this patient population, Dr. Furman said.
Dr. Wassif recently coauthored a paper that examined patients with underlying rheumatologic conditions who undergo valvular and aortic valve replacement. “To our surprise, there was really no difference between patients with autoimmune conditions and others with nonautoimmune conditions,” she said, adding that the study had its limitations.
Other work includes data on Medicare patients with ST- and non-ST-elevation myocardial infarctions who have an underlying autoimmune disorder. Dr. Wassif and her colleagues found that their long-term outcomes are worse than those of patients without these conditions. “It’s unclear if worse outcomes are related to complications of autoimmunity versus the extent of their underlying disease. This is a work in progress and certainly an area that is ripe for research.”
Dr. Garshick and other collaborators at NYU have been focusing on the endothelium, specifically platelet biology in patients with psoriasis, psoriatic arthritis, and lupus. “We’re about to start the same research with gout as well,” he said.
“The process we’re most interested in is understanding how these diseases impact the early stages of cholesterol. And the way we’re doing that is evaluating the vasculature, specifically the endothelium,” he said.
He has finished two clinical trials that evaluate how standard heart disease medications such as aspirin and statins impact or can potentially benefit patients with psoriasis and/or psoriatic arthritis. “We have a whole list of other trials in the pipeline with other institutions across the country.”
Through a grant, Dr. Mankad is assessing whether a PET scan could detect inflammation in the hearts of rheumatoid arthritis patients. “We’re looking to see if the reason these patients have heart failure later in life is because their heart muscle actually shows evidence of inflammation, even when they have no symptoms,” she explained.
Other tests such as echocardiogram and CT scans will be used to evaluate coronary disease in about 40-50 patients. The goal of using these multiple imaging tools is to find markers indicating that the heart is affected by rheumatoid arthritis, which may indicate a higher likelihood of developing heart failure, she said.
Clinics are popping up
Through these new clinics, some collaborations have emerged. Dr. Garshick works closely with Brigham and Women’s Hospital, which has a similar cardio-rheumatology program, run by Brittany Weber, MD, to exchange ideas, discuss challenging cases, and collaborate.
“There are a lot of clinics like us popping up across the country,” he observed. Every so often, he hears from other institutions that are interested in starting their own cardio-rheumatology programs. “They ask us: How do you start, what should we look for?”
It’s an education process for both patients and providers, Dr. Garshick emphasized. “I also think it’s a bandwidth issue. Many of our rheumatology and dermatology colleagues are acutely aware of the connection, but there may not be enough time at a clinic visit to really go in depth” with these dual conditions, he said.
NYU-Langone Health for the past several years has been holding a symposium to educate people on the cardio-rheumatology connection and treating inflammation in cardiovascular disease. This year’s symposium, held in conjunction with Brigham and Women’s Hospital, is scheduled for April 28. For more information, visit the course website: nyulmc.org/cvinflammationcme.
“What we’re trying to do is help [other institutions] get that bandwidth” to adequately help and serve these patients, he said.
Dr. Garshick has received consultant fees from Abbvie and Horizon therapeutics and an unrestricted research grant from Pfizer. No other sources had relevant financial disclosures.
Clinical cardiologist Heba Wassif, MD, MPH, knows the value of working with her fellow rheumatologists, surgeons, and other clinicians to establish a care plan for her patients with cardiac conditions and autoimmune diseases.
She is the cofounder of the Cleveland Clinic’s new cardio-rheumatology program, which places an emphasis on multidisciplinary care. In her role, Dr. Wassif closely follows her patients, and if she sees any inflammation or any other condition that requires the rheumatologist, she reaches out to her colleagues to adjust medications if needed.
Collaboration with a rheumatologist was important when a patient with valvular disease was prepping for surgery. The patient was on significant immunosuppressants and the surgery had to be timed appropriately, accounting for any decreases in her immunosuppression, explained Dr. Wassif, director of inpatient clinical cardiology at Cleveland Clinic in Ohio.
Cardio-rheumatology programs are “the newest child” in a series of cardiology offshoots focusing on different populations. Cardio-oncology and cardio-obstetrics took off about 6 years ago, with cardio-rheumatology clinics and interested physicians rising in number over the last several years, Dr. Wassif noted.
The relationship between cardiovascular diseases and rheumatologic conditions is certainly recognized more often, “which means more literature is being published to discuss the link,” according to Rekha Mankad, MD, a trailblazer of this model of care. She directs the Women’s Heart Clinic at Mayo Clinic in Rochester, Minn., which was one of the earliest adopters of a cardio-rheumatology clinic.
Ten years ago, “nobody was talking about the link between rheumatologic conditions and cardiovascular disease,” Dr. Mankad said. “I’ve been asked to speak on this topic, and programs have asked me to speak about establishing cardio-rheumatology practices. So, there’s been an evolution as far as a recognition that these two conditions overlap.”
Patients have come to her independent of internal referrals, which means they have done Google searches on cardiology and rheumatology. “I think that it has made a splash, at least in the world of cardiology,” Dr. Mankad observed in an interview.
Other institutions such as NYU-Langone, Yale, Stanford, Brigham and Women’s Hospital in Boston, and Women’s College Hospital in Toronto have formed similar clinics whose focus is to address the specific needs of rheumatology patients with cardiac conditions through a teamwork approach.
Challenges of treating cardiac, rheumatologic conditions
The rise in clinics addresses the longstanding connection between autoimmune disorders and cardiac conditions.
Cardiologists have known that there is an element of inflammation that contributes to atherosclerosis, said Dr. Wassif, who has researched this topic extensively. A recent study she led found a strong association between rheumatic immune-mediated inflammatory diseases (IMIDs) and high risk of acute coronary syndrome in Medicare patients.
“This particular population has a very clear increased risk for cardiovascular conditions, including valve disease and heart failure,” she emphasized.
Patients with rheumatoid arthritis and lupus have up to a twofold and eightfold higher risk of heart disease, respectively, noted Michael S. Garshick, MD, a cardiovascular disease specialist who directs the cardio-rheumatology program at NYU-Langone Health, in New York. Cardiologists “have really developed an understanding that the immune system can impact the heart, and that there’s a need for people to understand the nuance behind how the immune system can affect them and what to do about it,” Dr. Garshick said.
Caring for patients with both afflictions comes with specific challenges. Many physicians are not well trained on managing and treating patients with these dual conditions.
The “lipid paradox,” in which lipids are reduced with active inflammation in some rheumatologic conditions, can make treatment more nuanced. In addition, the traditional ASCVD (atherosclerotic cardiovascular disease) score often underestimates the cardiovascular risk of these patients, noted cardiologist Margaret Furman, MD, MPH, assistant professor and codirector of Yale’s Cardio-Rheumatology Program, New Haven, Conn.
Newer biologic medications used to treat rheumatologic diseases can alter a patient’s lipid profile, she said in an interview.
“It can be difficult to assess each individual patient’s cardiovascular risk as their disease state and treatment can vary throughout their lifetime based on their degree of inflammation. The importance of aggressive lipid management is often underestimated,” Dr. Furman added.
Cardiology and rheumatology partnerships can address gaps in care of this unique group of patients, said Vaidehi R. Chowdhary, MBBS, MD, clinical chief of the Yale Section of Rheumatology, Allergy, and Immunology at Yale University.
“The role of the rheumatologist in this dyad is to educate patients on this risk, work toward adequate control of inflammation, and minimize use of medications that contribute to increased cardiovascular risks,” said Dr. Chowdhary, who cofounded Yale’s cardio-rheumatology program with Dr. Furman.
Cardiologists in turn can assert their knowledge about medications and their impact on lipids and inflammation, Dr. Wassif said.
Many anti-inflammatory therapies are now within the cardiologist’s purview, Dr. Garshick noted. “For example, specifically with pericarditis, there’s [Food and Drug Administration]–approved anti-inflammatories or biologics. We’re the ones who feel the most comfortable giving them right now.” Cardiologists quite often are consulted about medications that are efficacious in rheumatologic conditions but could negatively impact the cardiovascular system, such as Janus kinase inhibitors, he added.
‘Reading the tea leaves’
Each program has its own unique story. For the Cleveland Clinic, the concept of a cardio-rheumatology program began during the COVID-19 pandemic in 2020. Developing such a concept and gaining institutional acceptance is always a work in process, Dr. Wassif said. “It’s not that you decide one day that you’re going to build a center, and that center is going to come into fruition overnight. You first gauge interest within your division. Who are the individuals that are interested in this area?”
Cleveland Clinic’s center is seeking to build relations between medical disciplines while spotlighting the concept of cardio-rheumatology, said Dr. Wassif, who has been providing education within the clinic and at other health institutions to ensure that patients receive appropriate attention early.
NYU-Langone launched its program amid this heightened awareness that the immune system could affect atherosclerosis, “kind of reading of the tea leaves, so to speak,” Dr. Garshick said.
Several clinical trials served as a catalyst for this movement. “A lot of clinical cardiologists were never 100% convinced that targeting the immune system reduced cardiovascular disease,” he said. Then the CANTOS clinical trial came along and showed for the first time that a therapeutic monoclonal antibody targeting interleukin-1beta, a cytokine central to inflammatory response, could in fact reduce cardiovascular disease.
Trials like this, along with epidemiologic literature connecting the rheumatologic and the autoimmune conditions with cardiovascular disease, pushed this concept to the forefront, Dr. Garshick said.
The notion that a clinic could successfully address cardiac problems in patients with rheumatic diseases yielded promising returns at Women’s College Hospital in Toronto, according to a report presented at the 2018 American College of Rheumatology annual meeting. Researchers reported that patients with rheumatologic conditions who attended a cardio-rheumatology clinic at this center saw improvements in care. The clinic identified increased cardiovascular risk and early atherosclerosis, and 53.8% of patients altered their medications after being seen in the clinic.
A total of 39.7% and 32.1% received lipid lowering and antiplatelet therapies, respectively, and 14% received antihypertensive therapy. A small percentage were treated for heart failure or placed on lifelong anticoagulation therapy for atrial fibrillation, and one patient received a percutaneous coronary stent.
Ins and outs of the referral process
Initially designed for preventive cardiac risk assessment, Yale’s program evolved into a multidisciplinary, patient-centered approach for the management of complex cardiovascular conditions in patients with autoimmune rheumatologic diseases.
The program is open to anyone who carries a diagnosis of rheumatologic disease or has elevated inflammatory markers. “Every patient, regardless of the reason for the referral, receives a cardiovascular risk assessment,” Dr. Furman said.
Most referrals come from rheumatologists, although cardiology colleagues and pulmonologists have also sent referrals. A pulmonologist, for example, may want to rule out a cardiac cause to shortness of breath. The patient’s workup, care, and follow-up are based on the reason for referral.
“We are currently referring patients with established cardiac disease, traditional risk factors, or for better risk assessment for primary prevention of coronary artery disease,” Dr. Chowdhary said. “We communicate very frequently about medication changes, and patients are aware of goals of care from both sides.”
Dr. Furman works closely with several of the rheumatology specialists taking care of patients with rheumatoid arthritis, systemic lupus erythematosus, and scleroderma.
Rheumatology follows patients every 3-6 months or more frequently based on their disease activity.
Dr. Mankad uses her sleuthing skills at Mayo Clinic to determine what the patients need. If they come in for a preventive assessment, she looks more closely at their cardiovascular risks and may order additional imaging to look for subclinical atherosclerosis. “We’re more aggressive with statin therapy in this population because of that,” she said.
If it’s valve disease, she pays extra attention to the patients’ valves in the echocardiograms and follows them a bit more regularly than someone without a rheumatologic condition and valve disease.
For patients with heart failure signs or symptoms, “it depends on how symptomatic they are,” Dr. Mankad said. In some instances, she may look for evidence of heart failure with preserved ejection fraction in patients who have rheumatoid arthritis who happen to be short of breath. “There’s so many different manifestations that patients with rheumatologic conditions can have as far as what could be affected in the heart,” she noted.
Quite frequently, Dr. Mankad identifies subclinical disease in her patients with rheumatoid arthritis. “I’ve seen many patients whose risk scores would not dictate statin therapy. But I went looking for subclinical disease by either doing coronary assessment or carotid assessment and have found atherosclerosis that would be enough to warrant statin therapy.”
A personalized assessment to reduce cardiac risk
NYU-Langone’s program offers opportunities to educate patients about the link between cardiac and rheumatologic disease.
“Their rheumatologist or their dermatologist will say, ‘Hey, have you heard about the connection between psoriasis, psoriatic or rheumatoid arthritis, and heart disease and the risk of heart attack or stroke?’ ” Dr. Garshick said.
The patients will often say they know nothing about these connections and want to learn more about how to treat it.
“We’ll say, ‘we have someone here that can help you.’ They’ll send them to myself or other colleagues like me across the country. We’ll assess blood pressure, weight, lipids, hemoglobin A1c, and other serologic and oftentimes imaging biomarkers of cardiovascular risk.” The patients will receive a personalized assessment, listing things they can do to lower their risk, whether it’s diet, exercise, or lifestyle. “Many times it can involve medications to reduce heart disease risk,” said Dr. Garshick.
In some instances, a rheumatologist or dermatologist may be concerned about starting a patient on a specific medication for the disease such as a JAK inhibitor. “We’ll help assess their risk because there’s been a lot of literature out in the rheumatology world about the risk of JAK inhibitors and heart disease and blood clots,” said Dr. Garshick.
Dr. Garshick also sees patients with rheumatologic conditions who have a specific cardiovascular concern or complaint such as shortness of breath or chest pain. “We’ll work that up with a specific knowledge of the underlying immune condition and how that may impact their heart,” he said.
Advances in research
As they continue to see patients and devise specific care plans, developers of cardio-rheumatology programs have been supplementing their work with ongoing research.
Yale’s clinic is expanding this year to include a new attending physician, Attila Feher, MD, PhD, who has conducted research in autoimmunity and microcirculation using molecular imaging and multimodality imaging techniques. Prevalence of coronary microvascular dysfunction appears to be increased in this patient population, Dr. Furman said.
Dr. Wassif recently coauthored a paper that examined patients with underlying rheumatologic conditions who undergo valvular and aortic valve replacement. “To our surprise, there was really no difference between patients with autoimmune conditions and others with nonautoimmune conditions,” she said, adding that the study had its limitations.
Other work includes data on Medicare patients with ST- and non-ST-elevation myocardial infarctions who have an underlying autoimmune disorder. Dr. Wassif and her colleagues found that their long-term outcomes are worse than those of patients without these conditions. “It’s unclear if worse outcomes are related to complications of autoimmunity versus the extent of their underlying disease. This is a work in progress and certainly an area that is ripe for research.”
Dr. Garshick and other collaborators at NYU have been focusing on the endothelium, specifically platelet biology in patients with psoriasis, psoriatic arthritis, and lupus. “We’re about to start the same research with gout as well,” he said.
“The process we’re most interested in is understanding how these diseases impact the early stages of cholesterol. And the way we’re doing that is evaluating the vasculature, specifically the endothelium,” he said.
He has finished two clinical trials that evaluate how standard heart disease medications such as aspirin and statins impact or can potentially benefit patients with psoriasis and/or psoriatic arthritis. “We have a whole list of other trials in the pipeline with other institutions across the country.”
Through a grant, Dr. Mankad is assessing whether a PET scan could detect inflammation in the hearts of rheumatoid arthritis patients. “We’re looking to see if the reason these patients have heart failure later in life is because their heart muscle actually shows evidence of inflammation, even when they have no symptoms,” she explained.
Other tests such as echocardiogram and CT scans will be used to evaluate coronary disease in about 40-50 patients. The goal of using these multiple imaging tools is to find markers indicating that the heart is affected by rheumatoid arthritis, which may indicate a higher likelihood of developing heart failure, she said.
Clinics are popping up
Through these new clinics, some collaborations have emerged. Dr. Garshick works closely with Brigham and Women’s Hospital, which has a similar cardio-rheumatology program, run by Brittany Weber, MD, to exchange ideas, discuss challenging cases, and collaborate.
“There are a lot of clinics like us popping up across the country,” he observed. Every so often, he hears from other institutions that are interested in starting their own cardio-rheumatology programs. “They ask us: How do you start, what should we look for?”
It’s an education process for both patients and providers, Dr. Garshick emphasized. “I also think it’s a bandwidth issue. Many of our rheumatology and dermatology colleagues are acutely aware of the connection, but there may not be enough time at a clinic visit to really go in depth” with these dual conditions, he said.
NYU-Langone Health for the past several years has been holding a symposium to educate people on the cardio-rheumatology connection and treating inflammation in cardiovascular disease. This year’s symposium, held in conjunction with Brigham and Women’s Hospital, is scheduled for April 28. For more information, visit the course website: nyulmc.org/cvinflammationcme.
“What we’re trying to do is help [other institutions] get that bandwidth” to adequately help and serve these patients, he said.
Dr. Garshick has received consultant fees from Abbvie and Horizon therapeutics and an unrestricted research grant from Pfizer. No other sources had relevant financial disclosures.
Kids with concussions may benefit from early return to school
The timing for return to school after a concussion has been the subject of guidelines, but data on how the timing of school returns affects later symptom burdens are limited, Christopher G. Vaughan, PhD, of Children’s National Hospital, Rockville, Md., and colleagues wrote.
Examining how the timing of return to school (RTS) affects later symptoms is needed to inform early postinjury management, they said.
In the new study published in JAMA Network Open, the researchers identified 1,630 children and teens aged 5-18 years who were treated for concussions at nine Canadian pediatric EDs. The primary outcome was symptom burden at 14 days post concussion, based on the Post-Concussion Symptom Inventory (PCSI). Early RTS was defined as missing fewer than 3 days of school post concussion.
Overall, the mean number of missed school days was 3.74 (excluding weekends). When divided by age, the mean number of missed days was 2.61 for children aged 5-7 years, 3.26 for those aged 8-12 years, and 4.71 for those aged 13-18 years.
Slightly more than half (53.7%) of the participants had an early RTS of 2 missed days or fewer. Later RTS was most common in the oldest age group, followed by the middle and younger age groups.
The researchers used a propensity score–matched analysis to determine associations. At 14 days, an early RTS was associated with reduced symptoms among 8- to 12-year-olds and 13- to 18-year-olds, though not in the youngest patients aged 5-7 years. In addition, the researchers created quantiles based on initial symptom ratings.
For the youngest age group, the association between early RTS and reduced symptoms at day 14 was higher among those with lower initial symptoms.
For the two older groups, the association was higher for those with higher initial symptoms (based on the PCSI).
The findings that earlier RTS was associated with a lower symptom burden at day 14 for those with higher levels of symptoms at baseline was surprising, but the mechanisms of the timing and effect of RTS requires more study, the researchers wrote in their discussion.
The effect of early RTS on symptoms may be in part related to factors such as “the benefits of socialization, reduced stress from not missing too much school, maintaining or returning to a normal sleep-wake schedule, and returning to light to moderate physical activity (gym class and recreational activities),” the researchers noted.
Another study related to recovery and concussion recently appeared in Neurology. In that study, the authors found that those athletes who took a longer time to recover from a sports-related concussion could still return to play with additional time off, but the methods and populations differed from the current study, which focused on RTS rather than returning to play.
The current study findings were limited by several factors including the lack of randomization for RTS timing and a lack of data on the variety of potential supports and accommodations students received, the researchers noted.
However, the results were strengthened by the large size and diverse nature of the concussions, and the roughly equal representation of boys and girls, they said.
Although randomized trials are needed to determine the best timing for RTS, the current study suggests that RTS within 2 days of a concussion is associated with improved symptoms, “and may directly or indirectly promote faster recovery,” they concluded.
Early return remains feasible for most children and teens
“Return to school can be a complicated issue for children and teens with concussions,” said Caitlyn Mooney, MD, a pediatrician and specialist in sports medicine at the University of Texas Health Science Center, San Antonio, said in an interview. Although much research has focused on diagnosis and return to sport after a concussion, there has been less focus on returning to school and learning. Various issues post concussion can make schooling difficult, and students may experience trouble with vision, concentration, sleep, headaches, and more.
Despite this knowledge, studies that specifically address recommended school protocols are limited, Dr. Mooney said. “Additionally, all concussions are different; while some students will need minimal help to return and succeed in school, others may need individualized learning plans and accommodations for school.” A return to school ideally would be a team-based approach with input from the parent, patient, physician, and educators.
“The theory of cognitive rest stems from the idea that a concussion causes metabolic dysfunction in the brain, and that increasing the metabolic demands of the brain can result in symptoms and a delayed return to school,” said Dr. Mooney.
Evidence suggests that those who start resting early after a concussion improve more quickly, “but there has been ongoing discussion over the years of what is the correct balance of cognitive rest to returning to modified activity,” she said. “This has led to the current general recommendation of rest for 24-48 hours followed by a gradual return to school as tolerated.”
Although the current study is large, it is limited by the lack of randomization, Dr. Mooney noted, therefore conclusions cannot be made that the cause of the improved symptoms is a quicker return to school.
However, the results support data from previous studies, in that both of the older age groups showed less disease burden at 14 days after an earlier return to school, she said.
“With prolonged absences, adolescents get isolated at home away from friends, and they may have increased mood symptoms. Additionally, I have found a high number of my patients who do not go to school as quickly have more sleep disturbance, which seems to increase symptoms such as difficulty concentrating or headaches,” she said. “It seems like the students do benefit from a routine schedule even if they have to have some accommodations at school, especially older students who may have more stress about missing school and falling behind on schoolwork.”
The message for pediatricians is that return to school should be individualized, Dr. Mooney said.
Although the current study does not dictate the optimal return to school, the results support those of previous studies in showing that, after 1-2 days of rest, an early return does not harm children and teens and may improve symptoms in many cases, she said. “In my experience, sometimes schools find it easier to keep the student at home rather than manage rest or special accommodations,” but the current study suggests that delaying return to school may not be the right choice for many patients.
“I hope this study empowers clinicians to advocate for these students, that the right place for them is in the classroom even with rest, extra time, or other accommodations,” said Dr. Mooney.
“Each concussion should be evaluated and treated individually; there will likely be a few who may need to stay home for a longer period of time, but this study suggests that the majority of students will suffer no ill effects from returning to the normal routine after a 2-day rest,” she noted.
The study was supported by the Canadian Institutes for Health Research. Dr. Vaughan and several coauthors disclosed being authors of the Postconcussion Symptom Inventory outside of the current study. Dr. Mooney had no financial conflicts to disclose.
The timing for return to school after a concussion has been the subject of guidelines, but data on how the timing of school returns affects later symptom burdens are limited, Christopher G. Vaughan, PhD, of Children’s National Hospital, Rockville, Md., and colleagues wrote.
Examining how the timing of return to school (RTS) affects later symptoms is needed to inform early postinjury management, they said.
In the new study published in JAMA Network Open, the researchers identified 1,630 children and teens aged 5-18 years who were treated for concussions at nine Canadian pediatric EDs. The primary outcome was symptom burden at 14 days post concussion, based on the Post-Concussion Symptom Inventory (PCSI). Early RTS was defined as missing fewer than 3 days of school post concussion.
Overall, the mean number of missed school days was 3.74 (excluding weekends). When divided by age, the mean number of missed days was 2.61 for children aged 5-7 years, 3.26 for those aged 8-12 years, and 4.71 for those aged 13-18 years.
Slightly more than half (53.7%) of the participants had an early RTS of 2 missed days or fewer. Later RTS was most common in the oldest age group, followed by the middle and younger age groups.
The researchers used a propensity score–matched analysis to determine associations. At 14 days, an early RTS was associated with reduced symptoms among 8- to 12-year-olds and 13- to 18-year-olds, though not in the youngest patients aged 5-7 years. In addition, the researchers created quantiles based on initial symptom ratings.
For the youngest age group, the association between early RTS and reduced symptoms at day 14 was higher among those with lower initial symptoms.
For the two older groups, the association was higher for those with higher initial symptoms (based on the PCSI).
The findings that earlier RTS was associated with a lower symptom burden at day 14 for those with higher levels of symptoms at baseline was surprising, but the mechanisms of the timing and effect of RTS requires more study, the researchers wrote in their discussion.
The effect of early RTS on symptoms may be in part related to factors such as “the benefits of socialization, reduced stress from not missing too much school, maintaining or returning to a normal sleep-wake schedule, and returning to light to moderate physical activity (gym class and recreational activities),” the researchers noted.
Another study related to recovery and concussion recently appeared in Neurology. In that study, the authors found that those athletes who took a longer time to recover from a sports-related concussion could still return to play with additional time off, but the methods and populations differed from the current study, which focused on RTS rather than returning to play.
The current study findings were limited by several factors including the lack of randomization for RTS timing and a lack of data on the variety of potential supports and accommodations students received, the researchers noted.
However, the results were strengthened by the large size and diverse nature of the concussions, and the roughly equal representation of boys and girls, they said.
Although randomized trials are needed to determine the best timing for RTS, the current study suggests that RTS within 2 days of a concussion is associated with improved symptoms, “and may directly or indirectly promote faster recovery,” they concluded.
Early return remains feasible for most children and teens
“Return to school can be a complicated issue for children and teens with concussions,” said Caitlyn Mooney, MD, a pediatrician and specialist in sports medicine at the University of Texas Health Science Center, San Antonio, said in an interview. Although much research has focused on diagnosis and return to sport after a concussion, there has been less focus on returning to school and learning. Various issues post concussion can make schooling difficult, and students may experience trouble with vision, concentration, sleep, headaches, and more.
Despite this knowledge, studies that specifically address recommended school protocols are limited, Dr. Mooney said. “Additionally, all concussions are different; while some students will need minimal help to return and succeed in school, others may need individualized learning plans and accommodations for school.” A return to school ideally would be a team-based approach with input from the parent, patient, physician, and educators.
“The theory of cognitive rest stems from the idea that a concussion causes metabolic dysfunction in the brain, and that increasing the metabolic demands of the brain can result in symptoms and a delayed return to school,” said Dr. Mooney.
Evidence suggests that those who start resting early after a concussion improve more quickly, “but there has been ongoing discussion over the years of what is the correct balance of cognitive rest to returning to modified activity,” she said. “This has led to the current general recommendation of rest for 24-48 hours followed by a gradual return to school as tolerated.”
Although the current study is large, it is limited by the lack of randomization, Dr. Mooney noted, therefore conclusions cannot be made that the cause of the improved symptoms is a quicker return to school.
However, the results support data from previous studies, in that both of the older age groups showed less disease burden at 14 days after an earlier return to school, she said.
“With prolonged absences, adolescents get isolated at home away from friends, and they may have increased mood symptoms. Additionally, I have found a high number of my patients who do not go to school as quickly have more sleep disturbance, which seems to increase symptoms such as difficulty concentrating or headaches,” she said. “It seems like the students do benefit from a routine schedule even if they have to have some accommodations at school, especially older students who may have more stress about missing school and falling behind on schoolwork.”
The message for pediatricians is that return to school should be individualized, Dr. Mooney said.
Although the current study does not dictate the optimal return to school, the results support those of previous studies in showing that, after 1-2 days of rest, an early return does not harm children and teens and may improve symptoms in many cases, she said. “In my experience, sometimes schools find it easier to keep the student at home rather than manage rest or special accommodations,” but the current study suggests that delaying return to school may not be the right choice for many patients.
“I hope this study empowers clinicians to advocate for these students, that the right place for them is in the classroom even with rest, extra time, or other accommodations,” said Dr. Mooney.
“Each concussion should be evaluated and treated individually; there will likely be a few who may need to stay home for a longer period of time, but this study suggests that the majority of students will suffer no ill effects from returning to the normal routine after a 2-day rest,” she noted.
The study was supported by the Canadian Institutes for Health Research. Dr. Vaughan and several coauthors disclosed being authors of the Postconcussion Symptom Inventory outside of the current study. Dr. Mooney had no financial conflicts to disclose.
The timing for return to school after a concussion has been the subject of guidelines, but data on how the timing of school returns affects later symptom burdens are limited, Christopher G. Vaughan, PhD, of Children’s National Hospital, Rockville, Md., and colleagues wrote.
Examining how the timing of return to school (RTS) affects later symptoms is needed to inform early postinjury management, they said.
In the new study published in JAMA Network Open, the researchers identified 1,630 children and teens aged 5-18 years who were treated for concussions at nine Canadian pediatric EDs. The primary outcome was symptom burden at 14 days post concussion, based on the Post-Concussion Symptom Inventory (PCSI). Early RTS was defined as missing fewer than 3 days of school post concussion.
Overall, the mean number of missed school days was 3.74 (excluding weekends). When divided by age, the mean number of missed days was 2.61 for children aged 5-7 years, 3.26 for those aged 8-12 years, and 4.71 for those aged 13-18 years.
Slightly more than half (53.7%) of the participants had an early RTS of 2 missed days or fewer. Later RTS was most common in the oldest age group, followed by the middle and younger age groups.
The researchers used a propensity score–matched analysis to determine associations. At 14 days, an early RTS was associated with reduced symptoms among 8- to 12-year-olds and 13- to 18-year-olds, though not in the youngest patients aged 5-7 years. In addition, the researchers created quantiles based on initial symptom ratings.
For the youngest age group, the association between early RTS and reduced symptoms at day 14 was higher among those with lower initial symptoms.
For the two older groups, the association was higher for those with higher initial symptoms (based on the PCSI).
The findings that earlier RTS was associated with a lower symptom burden at day 14 for those with higher levels of symptoms at baseline was surprising, but the mechanisms of the timing and effect of RTS requires more study, the researchers wrote in their discussion.
The effect of early RTS on symptoms may be in part related to factors such as “the benefits of socialization, reduced stress from not missing too much school, maintaining or returning to a normal sleep-wake schedule, and returning to light to moderate physical activity (gym class and recreational activities),” the researchers noted.
Another study related to recovery and concussion recently appeared in Neurology. In that study, the authors found that those athletes who took a longer time to recover from a sports-related concussion could still return to play with additional time off, but the methods and populations differed from the current study, which focused on RTS rather than returning to play.
The current study findings were limited by several factors including the lack of randomization for RTS timing and a lack of data on the variety of potential supports and accommodations students received, the researchers noted.
However, the results were strengthened by the large size and diverse nature of the concussions, and the roughly equal representation of boys and girls, they said.
Although randomized trials are needed to determine the best timing for RTS, the current study suggests that RTS within 2 days of a concussion is associated with improved symptoms, “and may directly or indirectly promote faster recovery,” they concluded.
Early return remains feasible for most children and teens
“Return to school can be a complicated issue for children and teens with concussions,” said Caitlyn Mooney, MD, a pediatrician and specialist in sports medicine at the University of Texas Health Science Center, San Antonio, said in an interview. Although much research has focused on diagnosis and return to sport after a concussion, there has been less focus on returning to school and learning. Various issues post concussion can make schooling difficult, and students may experience trouble with vision, concentration, sleep, headaches, and more.
Despite this knowledge, studies that specifically address recommended school protocols are limited, Dr. Mooney said. “Additionally, all concussions are different; while some students will need minimal help to return and succeed in school, others may need individualized learning plans and accommodations for school.” A return to school ideally would be a team-based approach with input from the parent, patient, physician, and educators.
“The theory of cognitive rest stems from the idea that a concussion causes metabolic dysfunction in the brain, and that increasing the metabolic demands of the brain can result in symptoms and a delayed return to school,” said Dr. Mooney.
Evidence suggests that those who start resting early after a concussion improve more quickly, “but there has been ongoing discussion over the years of what is the correct balance of cognitive rest to returning to modified activity,” she said. “This has led to the current general recommendation of rest for 24-48 hours followed by a gradual return to school as tolerated.”
Although the current study is large, it is limited by the lack of randomization, Dr. Mooney noted, therefore conclusions cannot be made that the cause of the improved symptoms is a quicker return to school.
However, the results support data from previous studies, in that both of the older age groups showed less disease burden at 14 days after an earlier return to school, she said.
“With prolonged absences, adolescents get isolated at home away from friends, and they may have increased mood symptoms. Additionally, I have found a high number of my patients who do not go to school as quickly have more sleep disturbance, which seems to increase symptoms such as difficulty concentrating or headaches,” she said. “It seems like the students do benefit from a routine schedule even if they have to have some accommodations at school, especially older students who may have more stress about missing school and falling behind on schoolwork.”
The message for pediatricians is that return to school should be individualized, Dr. Mooney said.
Although the current study does not dictate the optimal return to school, the results support those of previous studies in showing that, after 1-2 days of rest, an early return does not harm children and teens and may improve symptoms in many cases, she said. “In my experience, sometimes schools find it easier to keep the student at home rather than manage rest or special accommodations,” but the current study suggests that delaying return to school may not be the right choice for many patients.
“I hope this study empowers clinicians to advocate for these students, that the right place for them is in the classroom even with rest, extra time, or other accommodations,” said Dr. Mooney.
“Each concussion should be evaluated and treated individually; there will likely be a few who may need to stay home for a longer period of time, but this study suggests that the majority of students will suffer no ill effects from returning to the normal routine after a 2-day rest,” she noted.
The study was supported by the Canadian Institutes for Health Research. Dr. Vaughan and several coauthors disclosed being authors of the Postconcussion Symptom Inventory outside of the current study. Dr. Mooney had no financial conflicts to disclose.
FROM JAMA NETWORK OPEN
Off their pricey CML meds, many thrive
When imatinib (Gleevec) appeared on the market just over 2 decades ago, it revolutionized the treatment of chronic myelogenous leukemia (CML) and transformed it from a grim diagnosis into a largely treatable form of blood cancer. New generations of tyrosine kinase inhibitors (TKIs) have continued to expand options for patients, and many can look forward to normal lifespans.
But these medications cause side effects and can be expensive. Long-term data doesn’t exist for the newer therapies, so no one knows whether they can harm patients over time. None of this is particularly unusual for medications to treat chronic illness, but now there’s a twist:
“Our focus has changed because the results of treatment are so good,” hematologist-oncologist Ehab L. Atallah, MD, of the Medical College of Wisconsin, Milwaukee, said in an interview. “We’re trying to get people off their medication.”
Still, research estimates that only 20% of patients with CML will be eligible for treatment discontinuation and benefit from it in the long term. As a result, the wide majority of patients will need to be on drugs indefinitely.
Gleevec: A new age dawns
In the early 1990s, before the era of TKIs, the 5-year relative survival rate from CML was just 27%, and the 10-year rate was only 9.5%, according to a 2008 report. “If someone showed up with CML, their only option was to go to a bone marrow transplant. About half survived the transplant, and half of those had significant complications from it,” Dr. Atallah said. According to him, just about everyone who didn’t get transplantation would go on to die.
Then came Gleevec, which received Food and Drug Administration approval in 2001. It ushered in the era of “targeted” cancer treatment by specifically killing CML cells, instead of relying on traditional chemotherapy’s carpet-bombing approach.
“Gleevec and other TKIs have revolutionized how CML is treated, and patients are now living normal lives,” hematologist-oncologist Catherine Lai, MD, MPH, of the University of Pennsylvania, Philadelphia, said in an interview.
Alan Fahnestock, a 68-year-old retired telecommunications specialist in north-central Washington state, is one of the fortunate patients.
He was diagnosed with CML in 2004 after he underwent a thoracic CT scan in light of his tobacco use. “My GP found something odd in my lungs and referred me to a pulmonologist, who couldn’t figure it out either. He transmitted blood samples to my eventual hematologist/oncologist,” Mr. Fahnestock said in an interview. “It’s not clear to me that anybody ever figured out what the ‘oddity’ was. It has since apparently gone away. But the oncologist ran all the tests and came up with CML.”
Mr. Fahnestock hadn’t noticed any symptoms, although “this is, perhaps, because I tend not to pay a lot of attention to such things, having abused my body fairly severely over the years and having been borderline anemic since I was a kid. I don’t really expect to feel great and am a bit of a fatalist: I just get on with things until I no longer can.”
His physician prescribed Gleevec. “I had no particularly notable side effects, and carried on with my life pretty much as if nothing had happened,” Mr. Fahnestock said. He stayed on the drug for almost 20 years.
CML rooted in chromosome swap
It’s not clear exactly what causes CML, although the Mayo Clinic says most cases are linked to an abnormal, extra-short “Philadelphia chromosome,” created when two chromosomes swap material. This happens after birth.
Mr. Fahnestock thinks he happened to develop a random mutation. He also wonders if his work stints in the former Soviet Union in Vladivostok, “where the Soviet nuclear submarine fleet was decomposing,” and in Kiev, Ukraine, “which is not all that far from Chernobyl,” may be responsible.
Most patients, like Mr. Fahnestock, are men. Males will account for about 5,190 of the cases diagnosed in 2023, according to the American Cancer Society, compared to 3,740 in females.
Mr. Fahnestock’s CML diagnosis came at a fairly young age, when he was in his 40s. The average patient is diagnosed at 64. But it’s not unusual that he experienced no apparent symptoms when the cancer was found. In fact, that’s the norm.
Most patients with the disease – which is diagnosed in about 8,900 patients in the United States each year – are asymptomatic or have mild symptoms, Dr. Lai said. Their disease is discovered when “an elevated white count is found on routine blood work,” she said.
“The other group of patients typically present with very elevated white blood cell counts and splenomegaly with symptoms of fatigue and other constitutional symptoms. When the WBC count is very high, it is important to rule out transformation to accelerated or blast phase and also rule out an acute leukemia.”
Polymerase chain reaction is an especially important test during diagnosis, Dr. Atallah said, since it provides baseline data about the cancer that can be tracked.
TKIs: Mainstay of treatment
Four drugs are FDA approved for initial treatment of CML: imatinib (Gleevec), the second-generation TKIs dasatinib (Sprycel) and the third-generation TKI nilotinib (Tasigna). The third-generation TKIs bosutinib (Bosulif) and ponatinib (Iclusig) are approved for use as first-line treatments for patients who cannot tolerate the other drugs or are resistant to them.
The first-in-class drug asciminib (Scemblix), approved by the FDA in 2021, is a third-line drug for patients who failed treatment with two other TKIs and certain patients with the T315I mutation.
Dr. Lai said that it’s crucial to avoid side effects as much as possible “since the goal is for patients to be compliant and take the pill every day and not miss doses.” In younger patients, “I typically choose a second-generation TKI as my first choice, since there is a higher likelihood of getting into a deep molecular remission more quickly. If treatment-free remission is something a patient is interested in, a second-generation TKI is more likely to make this happen.”
According to Dr. Atallah, about half of patients end up using more than one drug because their initial choices either don’t work or cause intolerable side effects. Nevertheless, Dr. Lai noted: “Overall, patients do extremely well if compliant with their medication.”
Exceptions include the noncompliant and patients with more aggressive disease, like an accelerated or a blast phase, she said. For the latter patients, “allogenic bone marrow transplant should be considered once the patient is in remission.”
In remission, consider drug omission
How should patients be monitored if they are doing well?
“In general, I tend to follow patients monthly for the first six months after starting therapy, to make sure they are tolerating it well and to help manage side effects,” Dr. Lai said. “After that, I follow once every three months, and then often space out visits depending on whether they hit their molecular milestones and how long they’re in remission.”
In certain cases, patients may be taken off medication. The most recent National Comprehensive Cancer Network guidelines for treatment of CML, published in 2021, say that “discontinuation of TKI therapy (with close monitoring) is feasible in carefully selected, consenting patients” with early stage CML who’ve reached remission, defined as deep molecular response (DMR) of at least MR 4.0 for at least 2 years.
The guidelines caution that disease recurrence appears in “approximately 40%-60% of patients who discontinue TKI therapy after achieving DMR experience recurrence within 12 months of treatment cessation, in some cases as early as one month after discontinuation of TKI therapy.”
Still, the guidelines add that “resumption of TKI therapy immediately after recurrence results in the achievement of DMR in almost all patients.”
Dr. Atallah said stopping medication can be especially helpful for patients who grapple with side effects such as fatigue, diarrhea, and muscle aches. Some patients who take the drugs fear losing their health insurance and facing sky-high drug expenses. In 2018, average daily TKI costs for patients with CML were over $350, a 2020 report found.
Many patients were prescribed hugely expensive second-line treatments rather than inexpensive generic imatinib, the report said, despite “no evidence that later-generation TKIs provide superior progression free or overall survival.”
Many patients, however, refuse to consider stopping their medication, Dr. Atallah said. More data about treatment-free remission is needed, and the 21 U.S. academic medical centers in the H. Jean Khoury Cure CML Consortium are gathering information about patient outcomes.
Mr. Fahnestock is a fan of treatment-free remission. He stopped taking Gleevec about 2 years ago on the advice of his physician after he reached undetectable levels of disease.
“It was sort of a nonevent, really, with no discernible physical effects beyond exacerbation of the osteoarthritis in my hands,” he said. According to him, it’s not clear if this effect is linked to his eliminating the medication.
“I also vaguely hoped I’d feel better, even though I’d never been able to nail down any deleterious side effects,” he said. “No such luck, as it happens.”
Blood work has indicated no resurgence of the disease, and Mr. Fahnestock continues to volunteer as a rural firefighter.
“In general, I’m apparently reasonably healthy for my age, despite my folly [in younger years], and firefighting requires me to stay in reasonable shape,” he said. “I’ve recently been made aware of minor kidney issues and prediabetes. But, hell, I’m genetically scheduled to croak within 5 years or so, so why worry?”
National survival statistics in CML vary by factors such as gender and age, as a 2021 study revealed, and men have worse outcomes. Still, there’s a good chance Mr. Fahnestock won’t need to worry about CML ever again.
Dr. Atallah disclosed research support from Novartis and Takeda and has served both of those firms and Bristol-Myers Squibb as a consultant advisor. Dr. Lai discloses tied with Bristol-Myers Squibb, Jazz, Genentech, Novartis, Abbvie, Daiichi Sankyo, Astellas, MacroGenics, Servier, and Taiho. Mr. Fahnestock has no disclosures.
When imatinib (Gleevec) appeared on the market just over 2 decades ago, it revolutionized the treatment of chronic myelogenous leukemia (CML) and transformed it from a grim diagnosis into a largely treatable form of blood cancer. New generations of tyrosine kinase inhibitors (TKIs) have continued to expand options for patients, and many can look forward to normal lifespans.
But these medications cause side effects and can be expensive. Long-term data doesn’t exist for the newer therapies, so no one knows whether they can harm patients over time. None of this is particularly unusual for medications to treat chronic illness, but now there’s a twist:
“Our focus has changed because the results of treatment are so good,” hematologist-oncologist Ehab L. Atallah, MD, of the Medical College of Wisconsin, Milwaukee, said in an interview. “We’re trying to get people off their medication.”
Still, research estimates that only 20% of patients with CML will be eligible for treatment discontinuation and benefit from it in the long term. As a result, the wide majority of patients will need to be on drugs indefinitely.
Gleevec: A new age dawns
In the early 1990s, before the era of TKIs, the 5-year relative survival rate from CML was just 27%, and the 10-year rate was only 9.5%, according to a 2008 report. “If someone showed up with CML, their only option was to go to a bone marrow transplant. About half survived the transplant, and half of those had significant complications from it,” Dr. Atallah said. According to him, just about everyone who didn’t get transplantation would go on to die.
Then came Gleevec, which received Food and Drug Administration approval in 2001. It ushered in the era of “targeted” cancer treatment by specifically killing CML cells, instead of relying on traditional chemotherapy’s carpet-bombing approach.
“Gleevec and other TKIs have revolutionized how CML is treated, and patients are now living normal lives,” hematologist-oncologist Catherine Lai, MD, MPH, of the University of Pennsylvania, Philadelphia, said in an interview.
Alan Fahnestock, a 68-year-old retired telecommunications specialist in north-central Washington state, is one of the fortunate patients.
He was diagnosed with CML in 2004 after he underwent a thoracic CT scan in light of his tobacco use. “My GP found something odd in my lungs and referred me to a pulmonologist, who couldn’t figure it out either. He transmitted blood samples to my eventual hematologist/oncologist,” Mr. Fahnestock said in an interview. “It’s not clear to me that anybody ever figured out what the ‘oddity’ was. It has since apparently gone away. But the oncologist ran all the tests and came up with CML.”
Mr. Fahnestock hadn’t noticed any symptoms, although “this is, perhaps, because I tend not to pay a lot of attention to such things, having abused my body fairly severely over the years and having been borderline anemic since I was a kid. I don’t really expect to feel great and am a bit of a fatalist: I just get on with things until I no longer can.”
His physician prescribed Gleevec. “I had no particularly notable side effects, and carried on with my life pretty much as if nothing had happened,” Mr. Fahnestock said. He stayed on the drug for almost 20 years.
CML rooted in chromosome swap
It’s not clear exactly what causes CML, although the Mayo Clinic says most cases are linked to an abnormal, extra-short “Philadelphia chromosome,” created when two chromosomes swap material. This happens after birth.
Mr. Fahnestock thinks he happened to develop a random mutation. He also wonders if his work stints in the former Soviet Union in Vladivostok, “where the Soviet nuclear submarine fleet was decomposing,” and in Kiev, Ukraine, “which is not all that far from Chernobyl,” may be responsible.
Most patients, like Mr. Fahnestock, are men. Males will account for about 5,190 of the cases diagnosed in 2023, according to the American Cancer Society, compared to 3,740 in females.
Mr. Fahnestock’s CML diagnosis came at a fairly young age, when he was in his 40s. The average patient is diagnosed at 64. But it’s not unusual that he experienced no apparent symptoms when the cancer was found. In fact, that’s the norm.
Most patients with the disease – which is diagnosed in about 8,900 patients in the United States each year – are asymptomatic or have mild symptoms, Dr. Lai said. Their disease is discovered when “an elevated white count is found on routine blood work,” she said.
“The other group of patients typically present with very elevated white blood cell counts and splenomegaly with symptoms of fatigue and other constitutional symptoms. When the WBC count is very high, it is important to rule out transformation to accelerated or blast phase and also rule out an acute leukemia.”
Polymerase chain reaction is an especially important test during diagnosis, Dr. Atallah said, since it provides baseline data about the cancer that can be tracked.
TKIs: Mainstay of treatment
Four drugs are FDA approved for initial treatment of CML: imatinib (Gleevec), the second-generation TKIs dasatinib (Sprycel) and the third-generation TKI nilotinib (Tasigna). The third-generation TKIs bosutinib (Bosulif) and ponatinib (Iclusig) are approved for use as first-line treatments for patients who cannot tolerate the other drugs or are resistant to them.
The first-in-class drug asciminib (Scemblix), approved by the FDA in 2021, is a third-line drug for patients who failed treatment with two other TKIs and certain patients with the T315I mutation.
Dr. Lai said that it’s crucial to avoid side effects as much as possible “since the goal is for patients to be compliant and take the pill every day and not miss doses.” In younger patients, “I typically choose a second-generation TKI as my first choice, since there is a higher likelihood of getting into a deep molecular remission more quickly. If treatment-free remission is something a patient is interested in, a second-generation TKI is more likely to make this happen.”
According to Dr. Atallah, about half of patients end up using more than one drug because their initial choices either don’t work or cause intolerable side effects. Nevertheless, Dr. Lai noted: “Overall, patients do extremely well if compliant with their medication.”
Exceptions include the noncompliant and patients with more aggressive disease, like an accelerated or a blast phase, she said. For the latter patients, “allogenic bone marrow transplant should be considered once the patient is in remission.”
In remission, consider drug omission
How should patients be monitored if they are doing well?
“In general, I tend to follow patients monthly for the first six months after starting therapy, to make sure they are tolerating it well and to help manage side effects,” Dr. Lai said. “After that, I follow once every three months, and then often space out visits depending on whether they hit their molecular milestones and how long they’re in remission.”
In certain cases, patients may be taken off medication. The most recent National Comprehensive Cancer Network guidelines for treatment of CML, published in 2021, say that “discontinuation of TKI therapy (with close monitoring) is feasible in carefully selected, consenting patients” with early stage CML who’ve reached remission, defined as deep molecular response (DMR) of at least MR 4.0 for at least 2 years.
The guidelines caution that disease recurrence appears in “approximately 40%-60% of patients who discontinue TKI therapy after achieving DMR experience recurrence within 12 months of treatment cessation, in some cases as early as one month after discontinuation of TKI therapy.”
Still, the guidelines add that “resumption of TKI therapy immediately after recurrence results in the achievement of DMR in almost all patients.”
Dr. Atallah said stopping medication can be especially helpful for patients who grapple with side effects such as fatigue, diarrhea, and muscle aches. Some patients who take the drugs fear losing their health insurance and facing sky-high drug expenses. In 2018, average daily TKI costs for patients with CML were over $350, a 2020 report found.
Many patients were prescribed hugely expensive second-line treatments rather than inexpensive generic imatinib, the report said, despite “no evidence that later-generation TKIs provide superior progression free or overall survival.”
Many patients, however, refuse to consider stopping their medication, Dr. Atallah said. More data about treatment-free remission is needed, and the 21 U.S. academic medical centers in the H. Jean Khoury Cure CML Consortium are gathering information about patient outcomes.
Mr. Fahnestock is a fan of treatment-free remission. He stopped taking Gleevec about 2 years ago on the advice of his physician after he reached undetectable levels of disease.
“It was sort of a nonevent, really, with no discernible physical effects beyond exacerbation of the osteoarthritis in my hands,” he said. According to him, it’s not clear if this effect is linked to his eliminating the medication.
“I also vaguely hoped I’d feel better, even though I’d never been able to nail down any deleterious side effects,” he said. “No such luck, as it happens.”
Blood work has indicated no resurgence of the disease, and Mr. Fahnestock continues to volunteer as a rural firefighter.
“In general, I’m apparently reasonably healthy for my age, despite my folly [in younger years], and firefighting requires me to stay in reasonable shape,” he said. “I’ve recently been made aware of minor kidney issues and prediabetes. But, hell, I’m genetically scheduled to croak within 5 years or so, so why worry?”
National survival statistics in CML vary by factors such as gender and age, as a 2021 study revealed, and men have worse outcomes. Still, there’s a good chance Mr. Fahnestock won’t need to worry about CML ever again.
Dr. Atallah disclosed research support from Novartis and Takeda and has served both of those firms and Bristol-Myers Squibb as a consultant advisor. Dr. Lai discloses tied with Bristol-Myers Squibb, Jazz, Genentech, Novartis, Abbvie, Daiichi Sankyo, Astellas, MacroGenics, Servier, and Taiho. Mr. Fahnestock has no disclosures.
When imatinib (Gleevec) appeared on the market just over 2 decades ago, it revolutionized the treatment of chronic myelogenous leukemia (CML) and transformed it from a grim diagnosis into a largely treatable form of blood cancer. New generations of tyrosine kinase inhibitors (TKIs) have continued to expand options for patients, and many can look forward to normal lifespans.
But these medications cause side effects and can be expensive. Long-term data doesn’t exist for the newer therapies, so no one knows whether they can harm patients over time. None of this is particularly unusual for medications to treat chronic illness, but now there’s a twist:
“Our focus has changed because the results of treatment are so good,” hematologist-oncologist Ehab L. Atallah, MD, of the Medical College of Wisconsin, Milwaukee, said in an interview. “We’re trying to get people off their medication.”
Still, research estimates that only 20% of patients with CML will be eligible for treatment discontinuation and benefit from it in the long term. As a result, the wide majority of patients will need to be on drugs indefinitely.
Gleevec: A new age dawns
In the early 1990s, before the era of TKIs, the 5-year relative survival rate from CML was just 27%, and the 10-year rate was only 9.5%, according to a 2008 report. “If someone showed up with CML, their only option was to go to a bone marrow transplant. About half survived the transplant, and half of those had significant complications from it,” Dr. Atallah said. According to him, just about everyone who didn’t get transplantation would go on to die.
Then came Gleevec, which received Food and Drug Administration approval in 2001. It ushered in the era of “targeted” cancer treatment by specifically killing CML cells, instead of relying on traditional chemotherapy’s carpet-bombing approach.
“Gleevec and other TKIs have revolutionized how CML is treated, and patients are now living normal lives,” hematologist-oncologist Catherine Lai, MD, MPH, of the University of Pennsylvania, Philadelphia, said in an interview.
Alan Fahnestock, a 68-year-old retired telecommunications specialist in north-central Washington state, is one of the fortunate patients.
He was diagnosed with CML in 2004 after he underwent a thoracic CT scan in light of his tobacco use. “My GP found something odd in my lungs and referred me to a pulmonologist, who couldn’t figure it out either. He transmitted blood samples to my eventual hematologist/oncologist,” Mr. Fahnestock said in an interview. “It’s not clear to me that anybody ever figured out what the ‘oddity’ was. It has since apparently gone away. But the oncologist ran all the tests and came up with CML.”
Mr. Fahnestock hadn’t noticed any symptoms, although “this is, perhaps, because I tend not to pay a lot of attention to such things, having abused my body fairly severely over the years and having been borderline anemic since I was a kid. I don’t really expect to feel great and am a bit of a fatalist: I just get on with things until I no longer can.”
His physician prescribed Gleevec. “I had no particularly notable side effects, and carried on with my life pretty much as if nothing had happened,” Mr. Fahnestock said. He stayed on the drug for almost 20 years.
CML rooted in chromosome swap
It’s not clear exactly what causes CML, although the Mayo Clinic says most cases are linked to an abnormal, extra-short “Philadelphia chromosome,” created when two chromosomes swap material. This happens after birth.
Mr. Fahnestock thinks he happened to develop a random mutation. He also wonders if his work stints in the former Soviet Union in Vladivostok, “where the Soviet nuclear submarine fleet was decomposing,” and in Kiev, Ukraine, “which is not all that far from Chernobyl,” may be responsible.
Most patients, like Mr. Fahnestock, are men. Males will account for about 5,190 of the cases diagnosed in 2023, according to the American Cancer Society, compared to 3,740 in females.
Mr. Fahnestock’s CML diagnosis came at a fairly young age, when he was in his 40s. The average patient is diagnosed at 64. But it’s not unusual that he experienced no apparent symptoms when the cancer was found. In fact, that’s the norm.
Most patients with the disease – which is diagnosed in about 8,900 patients in the United States each year – are asymptomatic or have mild symptoms, Dr. Lai said. Their disease is discovered when “an elevated white count is found on routine blood work,” she said.
“The other group of patients typically present with very elevated white blood cell counts and splenomegaly with symptoms of fatigue and other constitutional symptoms. When the WBC count is very high, it is important to rule out transformation to accelerated or blast phase and also rule out an acute leukemia.”
Polymerase chain reaction is an especially important test during diagnosis, Dr. Atallah said, since it provides baseline data about the cancer that can be tracked.
TKIs: Mainstay of treatment
Four drugs are FDA approved for initial treatment of CML: imatinib (Gleevec), the second-generation TKIs dasatinib (Sprycel) and the third-generation TKI nilotinib (Tasigna). The third-generation TKIs bosutinib (Bosulif) and ponatinib (Iclusig) are approved for use as first-line treatments for patients who cannot tolerate the other drugs or are resistant to them.
The first-in-class drug asciminib (Scemblix), approved by the FDA in 2021, is a third-line drug for patients who failed treatment with two other TKIs and certain patients with the T315I mutation.
Dr. Lai said that it’s crucial to avoid side effects as much as possible “since the goal is for patients to be compliant and take the pill every day and not miss doses.” In younger patients, “I typically choose a second-generation TKI as my first choice, since there is a higher likelihood of getting into a deep molecular remission more quickly. If treatment-free remission is something a patient is interested in, a second-generation TKI is more likely to make this happen.”
According to Dr. Atallah, about half of patients end up using more than one drug because their initial choices either don’t work or cause intolerable side effects. Nevertheless, Dr. Lai noted: “Overall, patients do extremely well if compliant with their medication.”
Exceptions include the noncompliant and patients with more aggressive disease, like an accelerated or a blast phase, she said. For the latter patients, “allogenic bone marrow transplant should be considered once the patient is in remission.”
In remission, consider drug omission
How should patients be monitored if they are doing well?
“In general, I tend to follow patients monthly for the first six months after starting therapy, to make sure they are tolerating it well and to help manage side effects,” Dr. Lai said. “After that, I follow once every three months, and then often space out visits depending on whether they hit their molecular milestones and how long they’re in remission.”
In certain cases, patients may be taken off medication. The most recent National Comprehensive Cancer Network guidelines for treatment of CML, published in 2021, say that “discontinuation of TKI therapy (with close monitoring) is feasible in carefully selected, consenting patients” with early stage CML who’ve reached remission, defined as deep molecular response (DMR) of at least MR 4.0 for at least 2 years.
The guidelines caution that disease recurrence appears in “approximately 40%-60% of patients who discontinue TKI therapy after achieving DMR experience recurrence within 12 months of treatment cessation, in some cases as early as one month after discontinuation of TKI therapy.”
Still, the guidelines add that “resumption of TKI therapy immediately after recurrence results in the achievement of DMR in almost all patients.”
Dr. Atallah said stopping medication can be especially helpful for patients who grapple with side effects such as fatigue, diarrhea, and muscle aches. Some patients who take the drugs fear losing their health insurance and facing sky-high drug expenses. In 2018, average daily TKI costs for patients with CML were over $350, a 2020 report found.
Many patients were prescribed hugely expensive second-line treatments rather than inexpensive generic imatinib, the report said, despite “no evidence that later-generation TKIs provide superior progression free or overall survival.”
Many patients, however, refuse to consider stopping their medication, Dr. Atallah said. More data about treatment-free remission is needed, and the 21 U.S. academic medical centers in the H. Jean Khoury Cure CML Consortium are gathering information about patient outcomes.
Mr. Fahnestock is a fan of treatment-free remission. He stopped taking Gleevec about 2 years ago on the advice of his physician after he reached undetectable levels of disease.
“It was sort of a nonevent, really, with no discernible physical effects beyond exacerbation of the osteoarthritis in my hands,” he said. According to him, it’s not clear if this effect is linked to his eliminating the medication.
“I also vaguely hoped I’d feel better, even though I’d never been able to nail down any deleterious side effects,” he said. “No such luck, as it happens.”
Blood work has indicated no resurgence of the disease, and Mr. Fahnestock continues to volunteer as a rural firefighter.
“In general, I’m apparently reasonably healthy for my age, despite my folly [in younger years], and firefighting requires me to stay in reasonable shape,” he said. “I’ve recently been made aware of minor kidney issues and prediabetes. But, hell, I’m genetically scheduled to croak within 5 years or so, so why worry?”
National survival statistics in CML vary by factors such as gender and age, as a 2021 study revealed, and men have worse outcomes. Still, there’s a good chance Mr. Fahnestock won’t need to worry about CML ever again.
Dr. Atallah disclosed research support from Novartis and Takeda and has served both of those firms and Bristol-Myers Squibb as a consultant advisor. Dr. Lai discloses tied with Bristol-Myers Squibb, Jazz, Genentech, Novartis, Abbvie, Daiichi Sankyo, Astellas, MacroGenics, Servier, and Taiho. Mr. Fahnestock has no disclosures.
Phil Robinson: Rheumatologist, colleague, huntsman spider rescuer
Helen Tanner remembers stealing glimpses of her husband, Philip (“Phil”) Robinson, MBChB, PhD, associate professor at the University of Queensland (Australia), catching and rehoming huge Huntsman spiders. Robinson made the extra effort because he didn’t want to hurt them; he wasn’t a big fan of the large spider with a potential leg span of 6 inches that’s commonly found in Australia, per the Australian Museum.
Robinson also relished taking his children, Eddie, 4, and Tommy, 7, on roller coaster rides, which they enjoyed, despite the experience typically giving him motion sickness, Tanner said.
“He would do anything to make the children happy,” she said. “His children meant the world to him.”
Robinson died Jan. 3 as a result of diffuse gastric adenocarcinoma, according to his wife, who added that it was a short, 2-week-long illness.
A leader of global effort to understand COVID-19 and rheumatic disease
Jinoos Yazdany, MD, MPH, chief of the division of rheumatology at Zuckerberg San Francisco General Hospital and professor of medicine at the University of California, San Francisco, described Robinson as “one of the hardest-working people I have ever known. ... [still] his deep love and dedication for his family and kids was always present.”
Robinson would wake up early, even on weekends, to lead international calls across multiple time zones, Yazdany said. “He was driven by a deep curiosity and an intense desire to generate scholarship that would help people with rheumatic diseases.”
Yazdany added that Robinson had a full research portfolio in gout and spondyloarthritis and a busy clinical practice.
She often caught glimpses of Robinson’s young children during Zoom calls. “He was also a talented baker and loved to bake with his kids, often posting pictures of his creations on social media,” Yazdany said.
A mutual colleague compiled some of Robinson’s baking successes. That includes “ ‘probably about to be locked down’ cookies” on July 17, 2021, and “Queensland lockdown cookies!!!” on July 2, 2021. Reuters reported on July 21, 2021, that Australia was witnessing an alarming increase in COVID-19 cases.
Robinson also worked his social media skills to rally support for the COVID-19 Global Rheumatology Alliance, according to an article published by his colleagues in The Rheumatologist. Yazdany collaborated with him in this effort.
Launched on March 12, 2020, the Global Rheumatology Alliance’s mission is to “collect, analyze, and disseminate information about COVID-19 and rheumatology to patients, physicians, and other relevant groups to improve the care of patients with rheumatic disease.” Robinson served as chair of governance and policy for the collaborative effort.
Inspired by a conversation on Twitter by Leonard Calabrese, DO, a rheumatologist at the Cleveland Clinic in Ohio, about an outcomes registry created by gastroenterologists specific to patients with inflammatory bowel disease, Robinson launched a discussion about a similar effort for rheumatology on Twitter, they write.
Along with colleagues and within a single Zoom conference call, Yazdany and Robinson had a plan to organize the registry, Robinson’s colleagues write.
Two projects of the Global Rheumatology Alliance are a health care provider–entered registry for providers to enter data about rheumatology patients with COVID-19 infections, and their COVID-19 Vax Survey, which is available in 12 languages, including English.
Yazdany had never met Robinson before she started working with him on the Global Rheumatology Alliance. They started chatting on Twitter, then moved to Zoom conference calls, and subsequently had weeks when they talked by phone and “emailed constantly,” she said.
“As I reflect on our initial interactions, I am struck by how brilliantly we got along and trusted each other,” Yazdany told this news organization. “We both liked to think big, believed in inclusive collaborations, and were committed to helping people with rheumatic diseases during a scary and uncertain time.”
Still, Yazdany noted that she and Phil brought different strengths to their collaborations. She brought her skills related to the technical aspects of research databases, while “Phil worked his magic in mobilizing friends and colleagues from all over the world,” she said. “He served as a wonderful leader, one whom people believed in and would follow.”
The two colleagues, who spent much of their collaborations over Zoom calls, email, and Slack, while living more than 7,000 miles apart, finally met in person at ACR Convergence 2022, which took place in Philadelphia that year. “It felt like the best kind of reunion with a dear friend,” Yazdany remembered.
A mentor who created a platform for ‘good people to do great things’
David Liew, MBBS, PhD, consultant rheumatologist and clinical pharmacologist at Austin Health in Melbourne, marveled at Robinson’s ability to “distill things simply and cleanly, with clarity but without losing detail.” Liew, who collaborated with Robinson throughout the COVID-19 pandemic, likens the experience to “jamming with [jazz musician John] Coltrane.”
“What I think was particularly remarkable was the capacity to not only have those thoughts himself, but to facilitate others to have that springboard,” said Liew, who added that Robinson “took enormous pleasure in facilitating others’ success.”
“I think the greatest joy he drew out of the COVID-19 Global Rheumatology Alliance, apart from facing up to the challenge that needed to be faced, was creating a platform for good people to do great things,” said Liew, who recalled one situation where Robinson gently challenged him. Looking back now, Liew can “now see he very clearly was laying me up, giving me the best chance to shine.”
He describes Robinson as “a deep soul who loved his wife and two sons enormously” and “a whiskey aficionado.” “[Whiskey] suited his contemplative style,” Liew recalled. “Some of my fondest conversations with him were over a whiskey, either in person or virtually, pondering the ‘big issues.’”
A ‘friend and a colleague and so much more’
Claire Barrett, MBBS, president of the Australian Rheumatology Association, described Robinson as a “friend and a colleague and so much more. ... [He was] someone who I worked, laughed, ate, drank, danced, and had fun with,” she told this news organization. They served together as volunteers for the Australian Rheumatology Association and its Queensland branch, as well as Arthritis Queensland; they were also colleagues at Metro North Hospital and Health Service in Brisbane, Queensland.
Robinson was her “go to” for insightful comment on a variety of topics, she said. That could be advice on managing a patient with difficult gout, challenging spondyloarthritis, or the best treatment for a patient with COVID-19.
“[Phil] was a friend I could ask about anything, knowing I would not be judged,” Barrett said. “His kids and our grandkids are similar ages, so we would swap stories and photos and laugh about how cute/funny/cuddly/busy/etc. they were. My heart is broken he won’t get the chance to enjoy their future and the excitement of having Phil continuing to be such an active dad.”
Tanner, Robinson’s wife, said, “he loved everything.” That included the academic side of medicine, and working out what was wrong with his patients and helping them get better. “He was dedicated to this,” she added.
“He also loved the camaraderie of the job – all the people he met and interacted with. [Phil] loved sharing his ideas for research and also discussing complex patients with colleagues. He was driven by finding the answers to problems and doing this as part of a team of researchers/clinicians. He wasn’t interested in personal success.”
Robinson received his medical degree from Otago Medical School in Dunedin, New Zealand, according to the University of Queensland. His specialty training in general and acute care medicine and rheumatology was completed in Wellington, New Zealand, and Dunedin. Robinson also achieved a PhD in human genetics at the University of Queensland Diamantina Institute and had a postdoctoral fellowship at the Queensland Brain Institute at the University of Queensland.
Before his death, he worked at the Royal Brisbane and Women’s Hospital in Herston, Queensland, and at St. Andrew’s War Memorial Hospital in Spring Hill in Brisbane.
A version of this article first appeared on Medscape.com.
Helen Tanner remembers stealing glimpses of her husband, Philip (“Phil”) Robinson, MBChB, PhD, associate professor at the University of Queensland (Australia), catching and rehoming huge Huntsman spiders. Robinson made the extra effort because he didn’t want to hurt them; he wasn’t a big fan of the large spider with a potential leg span of 6 inches that’s commonly found in Australia, per the Australian Museum.
Robinson also relished taking his children, Eddie, 4, and Tommy, 7, on roller coaster rides, which they enjoyed, despite the experience typically giving him motion sickness, Tanner said.
“He would do anything to make the children happy,” she said. “His children meant the world to him.”
Robinson died Jan. 3 as a result of diffuse gastric adenocarcinoma, according to his wife, who added that it was a short, 2-week-long illness.
A leader of global effort to understand COVID-19 and rheumatic disease
Jinoos Yazdany, MD, MPH, chief of the division of rheumatology at Zuckerberg San Francisco General Hospital and professor of medicine at the University of California, San Francisco, described Robinson as “one of the hardest-working people I have ever known. ... [still] his deep love and dedication for his family and kids was always present.”
Robinson would wake up early, even on weekends, to lead international calls across multiple time zones, Yazdany said. “He was driven by a deep curiosity and an intense desire to generate scholarship that would help people with rheumatic diseases.”
Yazdany added that Robinson had a full research portfolio in gout and spondyloarthritis and a busy clinical practice.
She often caught glimpses of Robinson’s young children during Zoom calls. “He was also a talented baker and loved to bake with his kids, often posting pictures of his creations on social media,” Yazdany said.
A mutual colleague compiled some of Robinson’s baking successes. That includes “ ‘probably about to be locked down’ cookies” on July 17, 2021, and “Queensland lockdown cookies!!!” on July 2, 2021. Reuters reported on July 21, 2021, that Australia was witnessing an alarming increase in COVID-19 cases.
Robinson also worked his social media skills to rally support for the COVID-19 Global Rheumatology Alliance, according to an article published by his colleagues in The Rheumatologist. Yazdany collaborated with him in this effort.
Launched on March 12, 2020, the Global Rheumatology Alliance’s mission is to “collect, analyze, and disseminate information about COVID-19 and rheumatology to patients, physicians, and other relevant groups to improve the care of patients with rheumatic disease.” Robinson served as chair of governance and policy for the collaborative effort.
Inspired by a conversation on Twitter by Leonard Calabrese, DO, a rheumatologist at the Cleveland Clinic in Ohio, about an outcomes registry created by gastroenterologists specific to patients with inflammatory bowel disease, Robinson launched a discussion about a similar effort for rheumatology on Twitter, they write.
Along with colleagues and within a single Zoom conference call, Yazdany and Robinson had a plan to organize the registry, Robinson’s colleagues write.
Two projects of the Global Rheumatology Alliance are a health care provider–entered registry for providers to enter data about rheumatology patients with COVID-19 infections, and their COVID-19 Vax Survey, which is available in 12 languages, including English.
Yazdany had never met Robinson before she started working with him on the Global Rheumatology Alliance. They started chatting on Twitter, then moved to Zoom conference calls, and subsequently had weeks when they talked by phone and “emailed constantly,” she said.
“As I reflect on our initial interactions, I am struck by how brilliantly we got along and trusted each other,” Yazdany told this news organization. “We both liked to think big, believed in inclusive collaborations, and were committed to helping people with rheumatic diseases during a scary and uncertain time.”
Still, Yazdany noted that she and Phil brought different strengths to their collaborations. She brought her skills related to the technical aspects of research databases, while “Phil worked his magic in mobilizing friends and colleagues from all over the world,” she said. “He served as a wonderful leader, one whom people believed in and would follow.”
The two colleagues, who spent much of their collaborations over Zoom calls, email, and Slack, while living more than 7,000 miles apart, finally met in person at ACR Convergence 2022, which took place in Philadelphia that year. “It felt like the best kind of reunion with a dear friend,” Yazdany remembered.
A mentor who created a platform for ‘good people to do great things’
David Liew, MBBS, PhD, consultant rheumatologist and clinical pharmacologist at Austin Health in Melbourne, marveled at Robinson’s ability to “distill things simply and cleanly, with clarity but without losing detail.” Liew, who collaborated with Robinson throughout the COVID-19 pandemic, likens the experience to “jamming with [jazz musician John] Coltrane.”
“What I think was particularly remarkable was the capacity to not only have those thoughts himself, but to facilitate others to have that springboard,” said Liew, who added that Robinson “took enormous pleasure in facilitating others’ success.”
“I think the greatest joy he drew out of the COVID-19 Global Rheumatology Alliance, apart from facing up to the challenge that needed to be faced, was creating a platform for good people to do great things,” said Liew, who recalled one situation where Robinson gently challenged him. Looking back now, Liew can “now see he very clearly was laying me up, giving me the best chance to shine.”
He describes Robinson as “a deep soul who loved his wife and two sons enormously” and “a whiskey aficionado.” “[Whiskey] suited his contemplative style,” Liew recalled. “Some of my fondest conversations with him were over a whiskey, either in person or virtually, pondering the ‘big issues.’”
A ‘friend and a colleague and so much more’
Claire Barrett, MBBS, president of the Australian Rheumatology Association, described Robinson as a “friend and a colleague and so much more. ... [He was] someone who I worked, laughed, ate, drank, danced, and had fun with,” she told this news organization. They served together as volunteers for the Australian Rheumatology Association and its Queensland branch, as well as Arthritis Queensland; they were also colleagues at Metro North Hospital and Health Service in Brisbane, Queensland.
Robinson was her “go to” for insightful comment on a variety of topics, she said. That could be advice on managing a patient with difficult gout, challenging spondyloarthritis, or the best treatment for a patient with COVID-19.
“[Phil] was a friend I could ask about anything, knowing I would not be judged,” Barrett said. “His kids and our grandkids are similar ages, so we would swap stories and photos and laugh about how cute/funny/cuddly/busy/etc. they were. My heart is broken he won’t get the chance to enjoy their future and the excitement of having Phil continuing to be such an active dad.”
Tanner, Robinson’s wife, said, “he loved everything.” That included the academic side of medicine, and working out what was wrong with his patients and helping them get better. “He was dedicated to this,” she added.
“He also loved the camaraderie of the job – all the people he met and interacted with. [Phil] loved sharing his ideas for research and also discussing complex patients with colleagues. He was driven by finding the answers to problems and doing this as part of a team of researchers/clinicians. He wasn’t interested in personal success.”
Robinson received his medical degree from Otago Medical School in Dunedin, New Zealand, according to the University of Queensland. His specialty training in general and acute care medicine and rheumatology was completed in Wellington, New Zealand, and Dunedin. Robinson also achieved a PhD in human genetics at the University of Queensland Diamantina Institute and had a postdoctoral fellowship at the Queensland Brain Institute at the University of Queensland.
Before his death, he worked at the Royal Brisbane and Women’s Hospital in Herston, Queensland, and at St. Andrew’s War Memorial Hospital in Spring Hill in Brisbane.
A version of this article first appeared on Medscape.com.
Helen Tanner remembers stealing glimpses of her husband, Philip (“Phil”) Robinson, MBChB, PhD, associate professor at the University of Queensland (Australia), catching and rehoming huge Huntsman spiders. Robinson made the extra effort because he didn’t want to hurt them; he wasn’t a big fan of the large spider with a potential leg span of 6 inches that’s commonly found in Australia, per the Australian Museum.
Robinson also relished taking his children, Eddie, 4, and Tommy, 7, on roller coaster rides, which they enjoyed, despite the experience typically giving him motion sickness, Tanner said.
“He would do anything to make the children happy,” she said. “His children meant the world to him.”
Robinson died Jan. 3 as a result of diffuse gastric adenocarcinoma, according to his wife, who added that it was a short, 2-week-long illness.
A leader of global effort to understand COVID-19 and rheumatic disease
Jinoos Yazdany, MD, MPH, chief of the division of rheumatology at Zuckerberg San Francisco General Hospital and professor of medicine at the University of California, San Francisco, described Robinson as “one of the hardest-working people I have ever known. ... [still] his deep love and dedication for his family and kids was always present.”
Robinson would wake up early, even on weekends, to lead international calls across multiple time zones, Yazdany said. “He was driven by a deep curiosity and an intense desire to generate scholarship that would help people with rheumatic diseases.”
Yazdany added that Robinson had a full research portfolio in gout and spondyloarthritis and a busy clinical practice.
She often caught glimpses of Robinson’s young children during Zoom calls. “He was also a talented baker and loved to bake with his kids, often posting pictures of his creations on social media,” Yazdany said.
A mutual colleague compiled some of Robinson’s baking successes. That includes “ ‘probably about to be locked down’ cookies” on July 17, 2021, and “Queensland lockdown cookies!!!” on July 2, 2021. Reuters reported on July 21, 2021, that Australia was witnessing an alarming increase in COVID-19 cases.
Robinson also worked his social media skills to rally support for the COVID-19 Global Rheumatology Alliance, according to an article published by his colleagues in The Rheumatologist. Yazdany collaborated with him in this effort.
Launched on March 12, 2020, the Global Rheumatology Alliance’s mission is to “collect, analyze, and disseminate information about COVID-19 and rheumatology to patients, physicians, and other relevant groups to improve the care of patients with rheumatic disease.” Robinson served as chair of governance and policy for the collaborative effort.
Inspired by a conversation on Twitter by Leonard Calabrese, DO, a rheumatologist at the Cleveland Clinic in Ohio, about an outcomes registry created by gastroenterologists specific to patients with inflammatory bowel disease, Robinson launched a discussion about a similar effort for rheumatology on Twitter, they write.
Along with colleagues and within a single Zoom conference call, Yazdany and Robinson had a plan to organize the registry, Robinson’s colleagues write.
Two projects of the Global Rheumatology Alliance are a health care provider–entered registry for providers to enter data about rheumatology patients with COVID-19 infections, and their COVID-19 Vax Survey, which is available in 12 languages, including English.
Yazdany had never met Robinson before she started working with him on the Global Rheumatology Alliance. They started chatting on Twitter, then moved to Zoom conference calls, and subsequently had weeks when they talked by phone and “emailed constantly,” she said.
“As I reflect on our initial interactions, I am struck by how brilliantly we got along and trusted each other,” Yazdany told this news organization. “We both liked to think big, believed in inclusive collaborations, and were committed to helping people with rheumatic diseases during a scary and uncertain time.”
Still, Yazdany noted that she and Phil brought different strengths to their collaborations. She brought her skills related to the technical aspects of research databases, while “Phil worked his magic in mobilizing friends and colleagues from all over the world,” she said. “He served as a wonderful leader, one whom people believed in and would follow.”
The two colleagues, who spent much of their collaborations over Zoom calls, email, and Slack, while living more than 7,000 miles apart, finally met in person at ACR Convergence 2022, which took place in Philadelphia that year. “It felt like the best kind of reunion with a dear friend,” Yazdany remembered.
A mentor who created a platform for ‘good people to do great things’
David Liew, MBBS, PhD, consultant rheumatologist and clinical pharmacologist at Austin Health in Melbourne, marveled at Robinson’s ability to “distill things simply and cleanly, with clarity but without losing detail.” Liew, who collaborated with Robinson throughout the COVID-19 pandemic, likens the experience to “jamming with [jazz musician John] Coltrane.”
“What I think was particularly remarkable was the capacity to not only have those thoughts himself, but to facilitate others to have that springboard,” said Liew, who added that Robinson “took enormous pleasure in facilitating others’ success.”
“I think the greatest joy he drew out of the COVID-19 Global Rheumatology Alliance, apart from facing up to the challenge that needed to be faced, was creating a platform for good people to do great things,” said Liew, who recalled one situation where Robinson gently challenged him. Looking back now, Liew can “now see he very clearly was laying me up, giving me the best chance to shine.”
He describes Robinson as “a deep soul who loved his wife and two sons enormously” and “a whiskey aficionado.” “[Whiskey] suited his contemplative style,” Liew recalled. “Some of my fondest conversations with him were over a whiskey, either in person or virtually, pondering the ‘big issues.’”
A ‘friend and a colleague and so much more’
Claire Barrett, MBBS, president of the Australian Rheumatology Association, described Robinson as a “friend and a colleague and so much more. ... [He was] someone who I worked, laughed, ate, drank, danced, and had fun with,” she told this news organization. They served together as volunteers for the Australian Rheumatology Association and its Queensland branch, as well as Arthritis Queensland; they were also colleagues at Metro North Hospital and Health Service in Brisbane, Queensland.
Robinson was her “go to” for insightful comment on a variety of topics, she said. That could be advice on managing a patient with difficult gout, challenging spondyloarthritis, or the best treatment for a patient with COVID-19.
“[Phil] was a friend I could ask about anything, knowing I would not be judged,” Barrett said. “His kids and our grandkids are similar ages, so we would swap stories and photos and laugh about how cute/funny/cuddly/busy/etc. they were. My heart is broken he won’t get the chance to enjoy their future and the excitement of having Phil continuing to be such an active dad.”
Tanner, Robinson’s wife, said, “he loved everything.” That included the academic side of medicine, and working out what was wrong with his patients and helping them get better. “He was dedicated to this,” she added.
“He also loved the camaraderie of the job – all the people he met and interacted with. [Phil] loved sharing his ideas for research and also discussing complex patients with colleagues. He was driven by finding the answers to problems and doing this as part of a team of researchers/clinicians. He wasn’t interested in personal success.”
Robinson received his medical degree from Otago Medical School in Dunedin, New Zealand, according to the University of Queensland. His specialty training in general and acute care medicine and rheumatology was completed in Wellington, New Zealand, and Dunedin. Robinson also achieved a PhD in human genetics at the University of Queensland Diamantina Institute and had a postdoctoral fellowship at the Queensland Brain Institute at the University of Queensland.
Before his death, he worked at the Royal Brisbane and Women’s Hospital in Herston, Queensland, and at St. Andrew’s War Memorial Hospital in Spring Hill in Brisbane.
A version of this article first appeared on Medscape.com.
Highly anticipated HIV vaccine fails in large trial
officials announced Wednesday.
The vaccine had been in development since 2019 and was given to 3,900 study participants through October 2022, but data shows it does not protect against HIV compared with a placebo, according to developer Janssen Pharmaceutical.
Experts estimate the failure means there won’t be another potential vaccine on the horizon for 3 to 5 years, the New York Times reported.
“It’s obviously disappointing,” Anthony Fauci, MD, former head of the National Institute of Allergy and Infectious Diseases, told MSNBC, noting that other areas of HIV treatment research are promising. “I don’t think that people should give up on the field of the HIV vaccine.”
No safety issues had been identified with the vaccine during the trial, which studied the experimental treatment in men who have sex with men or with transgender people.
There is no cure for HIV, but disease progression can be managed with existing treatments. HIV attacks the body’s immune system and destroys white blood cells, increasing the risk of other infections. More than 1.5 million people worldwide were infected with HIV in 2021 and 38.4 million people are living with the virus, according to UNAIDS.
A version of this article first appeared on WebMD.com.
officials announced Wednesday.
The vaccine had been in development since 2019 and was given to 3,900 study participants through October 2022, but data shows it does not protect against HIV compared with a placebo, according to developer Janssen Pharmaceutical.
Experts estimate the failure means there won’t be another potential vaccine on the horizon for 3 to 5 years, the New York Times reported.
“It’s obviously disappointing,” Anthony Fauci, MD, former head of the National Institute of Allergy and Infectious Diseases, told MSNBC, noting that other areas of HIV treatment research are promising. “I don’t think that people should give up on the field of the HIV vaccine.”
No safety issues had been identified with the vaccine during the trial, which studied the experimental treatment in men who have sex with men or with transgender people.
There is no cure for HIV, but disease progression can be managed with existing treatments. HIV attacks the body’s immune system and destroys white blood cells, increasing the risk of other infections. More than 1.5 million people worldwide were infected with HIV in 2021 and 38.4 million people are living with the virus, according to UNAIDS.
A version of this article first appeared on WebMD.com.
officials announced Wednesday.
The vaccine had been in development since 2019 and was given to 3,900 study participants through October 2022, but data shows it does not protect against HIV compared with a placebo, according to developer Janssen Pharmaceutical.
Experts estimate the failure means there won’t be another potential vaccine on the horizon for 3 to 5 years, the New York Times reported.
“It’s obviously disappointing,” Anthony Fauci, MD, former head of the National Institute of Allergy and Infectious Diseases, told MSNBC, noting that other areas of HIV treatment research are promising. “I don’t think that people should give up on the field of the HIV vaccine.”
No safety issues had been identified with the vaccine during the trial, which studied the experimental treatment in men who have sex with men or with transgender people.
There is no cure for HIV, but disease progression can be managed with existing treatments. HIV attacks the body’s immune system and destroys white blood cells, increasing the risk of other infections. More than 1.5 million people worldwide were infected with HIV in 2021 and 38.4 million people are living with the virus, according to UNAIDS.
A version of this article first appeared on WebMD.com.
Is it time for yet another COVID booster? It’s complicated
For some people who have received a two-dose primary series and all the recommended boosters, that could mean a sixth shot since COVID-19 vaccines became available. But is even that enough (or too much)?
At this point, no one knows for sure, but new guidance may be on the docket.
On Jan. 26, the FDA’s Vaccines and Related Biological Products Advisory Committee is meeting. On the agenda is discussion about plans for future vaccinations for COVID-19.The committee, made up of external advisers, evaluates data on vaccines and other products for the agency.
According to the FDA announcement, after the meeting, “the FDA will consider whether to recommend adjustments to the current authorizations and approvals, and the FDA will consider the most efficient and transparent process to use for selection of strains for inclusion in the primary and booster vaccines.”
From there, the CDC will take up the issue and decide on recommendations.
The issue is important, as more than 550 Americans a day are still dying from COVID-19, as of the week ending Jan. 13, the CDC reported. That’s up from 346 a day for the week ending Dec. 28.
Yet, uptake of the newest vaccine, the bivalent booster, has been slow. As of Jan. 11, just 15.9% of the population 5 years and up has gotten it; for those most vulnerable to COVID19 – those 65 and up – the number is just 39%.
COVID vaccines, 2023 and beyond
Meanwhile, infectious disease experts have widely differing views on what the vaccination landscape of 2023 and beyond should look like. Among the areas of disagreement are how effective the bivalent vaccine is, which people most need another shot, and what type of vaccine is best.
“I think we probably will need another booster,” says Peter Hotez, MD, PhD, dean of the National School of Tropical Medicine at Baylor College of Medicine, and codirector of the Center for Vaccine Development at Texas Children’s Hospital in Houston. “The question is, what is it going to be? Is it going to be the same bivalent that we just got, or will it be a new bivalent or even a trivalent?”
The trivalent booster, he suggested, might include something more protective against XBB.1.5.
The bivalent booster gives “broadened immunity” that is improved from the original booster shots, says Eric Topol, MD, founder and director of the Scripps Research Translational Institute in La Jolla, Calif., and editor-in-chief of Medscape, WebMD’s sister site for health professionals.
In his publication Ground Truths, Dr. Topol on Jan. 11 explained how new data caused him to reverse his previously skeptical view of how the FDA authorized the bivalent vaccine in September without data on how it affected humans at the time.
Paul Offit, MD, director of the Vaccine Education Center and a professor of pediatrics at the Children’s Hospital of Philadelphia, is a member of the FDA advisory committee for vaccines. He still takes a dimmer view of more bivalent booster vaccines, at least as a blanket recommendation.
While he acknowledges that boosters can help some groups – such as older adults, people with multiple health conditions, and those with compromised immune systems – he opposes a recommendation that’s population-wide.
“People who fall into those three groups do benefit,” he says, “but the recommendation is everyone over 6 months get the bivalent, and what I’m asking is, ‘Where is the data that a healthy 12-year-old boy needs a booster to stay out of the hospital?’ ”
Evolving research
“We are trying to understand how to stay one step ahead rather than several steps behind [the virus],“ says Michael Osterholm, PhD, director of the Center for Infectious Disease Research and Policy at the University of Minnesota.
Among the key questions: How well can a vaccine work against a single subvariant, when no one can say for sure what the next predominant subvariant will be?
Much more research has become available recently about the bivalent vaccine and its effectiveness, Dr. Osterholm says. “The bivalent vaccine is working as well as we could have expected,” he says, especially in high-risk people and in those over age 65. “The challenge we have is, what does that mean going forward?”
In his review, Dr. Topol concludes: “There is now more than ample, highly consistent evidence via lab studies and clinical outcomes to support the bivalent’s benefit over the original booster.”
Among other evidence, he looked at eight studies, including four that used a live virus as part of the research. Six of the eight studies showed the bivalent booster is more effective against the BA.5 variant, compared with the original booster shots. Two others showed no real difference.
“The four live virus studies offer consistent evidence of broadened immunity for the BA.5 vaccine that is improved over the original booster shots,” Dr. Topol wrote. The evidence also found the bivalent antibody response superior against XBB, he wrote.
Dr. Topol also cited CDC data that supports the benefits of the bivalent shot on hospitalization in older adults. During November, hospitalization of adults 65 and above was 2.5 times higher for those vaccinated who did not get the booster, compared to those who got the updated bivalent booster.
Boosters do matter, Dr. Offit says. “But not for all.” In a perspective published Jan. 11 in the New England Journal of Medicine – the same issue that published the two studies finding few differences between the original and bivalent – Dr. Offit wrote that boosting is best reserved for vulnerable groups.
Chasing the variants with a bivalent vaccine, he says, “has not panned out. There remains no evidence that a bivalent vaccine is any better than what we had. Please, show me the data that one is better than the other.”
Dr. Offit believes the goal should not be to prevent all symptomatic infections in healthy, young people by boosting them “with vaccines containing mRNA from strains that might disappear a few months later.”
The CDC needs to parse the data by subgroups, Dr. Offit says. “The critical question is, ‘Who gets hospitalized and who is dying? Who are they?’ ”
That data should take into account age, ethnicity, vaccine history, and other factors, Dr. Offit says, because right now, there is no great data to say, “OK, everyone gets a boost.”
Future vaccine costs
Another debate – for not only current boosters but future ones, too – centers on cost. Without congressional action to fund more vaccines, vaccine makers have suggested their prices may reach $130 a dose, compared with the average $20-per-dose cost the federal government pays now, according to a Kaiser Family Foundation report.
The government has spent more than $30 billion on COVID-19 vaccines, including the bivalent, to provide them free of charge.
The suggested price increase infuriated many. On Jan. 10, Sen. Bernie Sanders (I-Vt.), incoming chair of the Senate Committee on Health, Education, Labor and Pensions, sent a letter to Moderna CEO Stéphane Bancel, urging him to reconsider and refrain from any price increase.
“The huge increase in price that you have proposed will have a significantly negative impact on the budgets of Medicaid, Medicare and other government programs that will continue covering the vaccine without cost-sharing for patients.”
He pointed out, too, the $19 billion in profits Moderna has made over the past 2 years.
While most people with health insurance would likely still get the vaccines and booster for free, according to the Kaiser analysis, will a higher price discourage people from keeping up with recommended vaccinations, including a possible new booster?
“I think so, yes,” Dr. Hotez says, noting that vaccine reluctance is high as it is, even with free vaccinations and easy access.
“The government is balking at paying for the boosters,” he says. “I think it’s very tone deaf from the pharmaceutical companies [to increase the price]. Given all the help they’ve gotten from the American people, I think they should not be gouging at this point.”
He noted that the federal government provided not just money to the companies for the vaccines, but a “glide path” through the FDA for the vaccine approvals.
Are new, variant-specific boosters coming?
Are Moderna, Pfizer-BioNTech, and others developing more variant-specific vaccines, boosters, or other advances?
Novavax, approved in July 2022 as a primary series and in some cases as a booster, is “also developing an Omicron-containing bivalent vaccine at the direction of public health agencies,” says spokesperson Alison Chartan.
Pfizer responded: “When and if we have something to share we will let you know.”
Moderna did not respond.
A version of this article first appeared on WebMD.com.
For some people who have received a two-dose primary series and all the recommended boosters, that could mean a sixth shot since COVID-19 vaccines became available. But is even that enough (or too much)?
At this point, no one knows for sure, but new guidance may be on the docket.
On Jan. 26, the FDA’s Vaccines and Related Biological Products Advisory Committee is meeting. On the agenda is discussion about plans for future vaccinations for COVID-19.The committee, made up of external advisers, evaluates data on vaccines and other products for the agency.
According to the FDA announcement, after the meeting, “the FDA will consider whether to recommend adjustments to the current authorizations and approvals, and the FDA will consider the most efficient and transparent process to use for selection of strains for inclusion in the primary and booster vaccines.”
From there, the CDC will take up the issue and decide on recommendations.
The issue is important, as more than 550 Americans a day are still dying from COVID-19, as of the week ending Jan. 13, the CDC reported. That’s up from 346 a day for the week ending Dec. 28.
Yet, uptake of the newest vaccine, the bivalent booster, has been slow. As of Jan. 11, just 15.9% of the population 5 years and up has gotten it; for those most vulnerable to COVID19 – those 65 and up – the number is just 39%.
COVID vaccines, 2023 and beyond
Meanwhile, infectious disease experts have widely differing views on what the vaccination landscape of 2023 and beyond should look like. Among the areas of disagreement are how effective the bivalent vaccine is, which people most need another shot, and what type of vaccine is best.
“I think we probably will need another booster,” says Peter Hotez, MD, PhD, dean of the National School of Tropical Medicine at Baylor College of Medicine, and codirector of the Center for Vaccine Development at Texas Children’s Hospital in Houston. “The question is, what is it going to be? Is it going to be the same bivalent that we just got, or will it be a new bivalent or even a trivalent?”
The trivalent booster, he suggested, might include something more protective against XBB.1.5.
The bivalent booster gives “broadened immunity” that is improved from the original booster shots, says Eric Topol, MD, founder and director of the Scripps Research Translational Institute in La Jolla, Calif., and editor-in-chief of Medscape, WebMD’s sister site for health professionals.
In his publication Ground Truths, Dr. Topol on Jan. 11 explained how new data caused him to reverse his previously skeptical view of how the FDA authorized the bivalent vaccine in September without data on how it affected humans at the time.
Paul Offit, MD, director of the Vaccine Education Center and a professor of pediatrics at the Children’s Hospital of Philadelphia, is a member of the FDA advisory committee for vaccines. He still takes a dimmer view of more bivalent booster vaccines, at least as a blanket recommendation.
While he acknowledges that boosters can help some groups – such as older adults, people with multiple health conditions, and those with compromised immune systems – he opposes a recommendation that’s population-wide.
“People who fall into those three groups do benefit,” he says, “but the recommendation is everyone over 6 months get the bivalent, and what I’m asking is, ‘Where is the data that a healthy 12-year-old boy needs a booster to stay out of the hospital?’ ”
Evolving research
“We are trying to understand how to stay one step ahead rather than several steps behind [the virus],“ says Michael Osterholm, PhD, director of the Center for Infectious Disease Research and Policy at the University of Minnesota.
Among the key questions: How well can a vaccine work against a single subvariant, when no one can say for sure what the next predominant subvariant will be?
Much more research has become available recently about the bivalent vaccine and its effectiveness, Dr. Osterholm says. “The bivalent vaccine is working as well as we could have expected,” he says, especially in high-risk people and in those over age 65. “The challenge we have is, what does that mean going forward?”
In his review, Dr. Topol concludes: “There is now more than ample, highly consistent evidence via lab studies and clinical outcomes to support the bivalent’s benefit over the original booster.”
Among other evidence, he looked at eight studies, including four that used a live virus as part of the research. Six of the eight studies showed the bivalent booster is more effective against the BA.5 variant, compared with the original booster shots. Two others showed no real difference.
“The four live virus studies offer consistent evidence of broadened immunity for the BA.5 vaccine that is improved over the original booster shots,” Dr. Topol wrote. The evidence also found the bivalent antibody response superior against XBB, he wrote.
Dr. Topol also cited CDC data that supports the benefits of the bivalent shot on hospitalization in older adults. During November, hospitalization of adults 65 and above was 2.5 times higher for those vaccinated who did not get the booster, compared to those who got the updated bivalent booster.
Boosters do matter, Dr. Offit says. “But not for all.” In a perspective published Jan. 11 in the New England Journal of Medicine – the same issue that published the two studies finding few differences between the original and bivalent – Dr. Offit wrote that boosting is best reserved for vulnerable groups.
Chasing the variants with a bivalent vaccine, he says, “has not panned out. There remains no evidence that a bivalent vaccine is any better than what we had. Please, show me the data that one is better than the other.”
Dr. Offit believes the goal should not be to prevent all symptomatic infections in healthy, young people by boosting them “with vaccines containing mRNA from strains that might disappear a few months later.”
The CDC needs to parse the data by subgroups, Dr. Offit says. “The critical question is, ‘Who gets hospitalized and who is dying? Who are they?’ ”
That data should take into account age, ethnicity, vaccine history, and other factors, Dr. Offit says, because right now, there is no great data to say, “OK, everyone gets a boost.”
Future vaccine costs
Another debate – for not only current boosters but future ones, too – centers on cost. Without congressional action to fund more vaccines, vaccine makers have suggested their prices may reach $130 a dose, compared with the average $20-per-dose cost the federal government pays now, according to a Kaiser Family Foundation report.
The government has spent more than $30 billion on COVID-19 vaccines, including the bivalent, to provide them free of charge.
The suggested price increase infuriated many. On Jan. 10, Sen. Bernie Sanders (I-Vt.), incoming chair of the Senate Committee on Health, Education, Labor and Pensions, sent a letter to Moderna CEO Stéphane Bancel, urging him to reconsider and refrain from any price increase.
“The huge increase in price that you have proposed will have a significantly negative impact on the budgets of Medicaid, Medicare and other government programs that will continue covering the vaccine without cost-sharing for patients.”
He pointed out, too, the $19 billion in profits Moderna has made over the past 2 years.
While most people with health insurance would likely still get the vaccines and booster for free, according to the Kaiser analysis, will a higher price discourage people from keeping up with recommended vaccinations, including a possible new booster?
“I think so, yes,” Dr. Hotez says, noting that vaccine reluctance is high as it is, even with free vaccinations and easy access.
“The government is balking at paying for the boosters,” he says. “I think it’s very tone deaf from the pharmaceutical companies [to increase the price]. Given all the help they’ve gotten from the American people, I think they should not be gouging at this point.”
He noted that the federal government provided not just money to the companies for the vaccines, but a “glide path” through the FDA for the vaccine approvals.
Are new, variant-specific boosters coming?
Are Moderna, Pfizer-BioNTech, and others developing more variant-specific vaccines, boosters, or other advances?
Novavax, approved in July 2022 as a primary series and in some cases as a booster, is “also developing an Omicron-containing bivalent vaccine at the direction of public health agencies,” says spokesperson Alison Chartan.
Pfizer responded: “When and if we have something to share we will let you know.”
Moderna did not respond.
A version of this article first appeared on WebMD.com.
For some people who have received a two-dose primary series and all the recommended boosters, that could mean a sixth shot since COVID-19 vaccines became available. But is even that enough (or too much)?
At this point, no one knows for sure, but new guidance may be on the docket.
On Jan. 26, the FDA’s Vaccines and Related Biological Products Advisory Committee is meeting. On the agenda is discussion about plans for future vaccinations for COVID-19.The committee, made up of external advisers, evaluates data on vaccines and other products for the agency.
According to the FDA announcement, after the meeting, “the FDA will consider whether to recommend adjustments to the current authorizations and approvals, and the FDA will consider the most efficient and transparent process to use for selection of strains for inclusion in the primary and booster vaccines.”
From there, the CDC will take up the issue and decide on recommendations.
The issue is important, as more than 550 Americans a day are still dying from COVID-19, as of the week ending Jan. 13, the CDC reported. That’s up from 346 a day for the week ending Dec. 28.
Yet, uptake of the newest vaccine, the bivalent booster, has been slow. As of Jan. 11, just 15.9% of the population 5 years and up has gotten it; for those most vulnerable to COVID19 – those 65 and up – the number is just 39%.
COVID vaccines, 2023 and beyond
Meanwhile, infectious disease experts have widely differing views on what the vaccination landscape of 2023 and beyond should look like. Among the areas of disagreement are how effective the bivalent vaccine is, which people most need another shot, and what type of vaccine is best.
“I think we probably will need another booster,” says Peter Hotez, MD, PhD, dean of the National School of Tropical Medicine at Baylor College of Medicine, and codirector of the Center for Vaccine Development at Texas Children’s Hospital in Houston. “The question is, what is it going to be? Is it going to be the same bivalent that we just got, or will it be a new bivalent or even a trivalent?”
The trivalent booster, he suggested, might include something more protective against XBB.1.5.
The bivalent booster gives “broadened immunity” that is improved from the original booster shots, says Eric Topol, MD, founder and director of the Scripps Research Translational Institute in La Jolla, Calif., and editor-in-chief of Medscape, WebMD’s sister site for health professionals.
In his publication Ground Truths, Dr. Topol on Jan. 11 explained how new data caused him to reverse his previously skeptical view of how the FDA authorized the bivalent vaccine in September without data on how it affected humans at the time.
Paul Offit, MD, director of the Vaccine Education Center and a professor of pediatrics at the Children’s Hospital of Philadelphia, is a member of the FDA advisory committee for vaccines. He still takes a dimmer view of more bivalent booster vaccines, at least as a blanket recommendation.
While he acknowledges that boosters can help some groups – such as older adults, people with multiple health conditions, and those with compromised immune systems – he opposes a recommendation that’s population-wide.
“People who fall into those three groups do benefit,” he says, “but the recommendation is everyone over 6 months get the bivalent, and what I’m asking is, ‘Where is the data that a healthy 12-year-old boy needs a booster to stay out of the hospital?’ ”
Evolving research
“We are trying to understand how to stay one step ahead rather than several steps behind [the virus],“ says Michael Osterholm, PhD, director of the Center for Infectious Disease Research and Policy at the University of Minnesota.
Among the key questions: How well can a vaccine work against a single subvariant, when no one can say for sure what the next predominant subvariant will be?
Much more research has become available recently about the bivalent vaccine and its effectiveness, Dr. Osterholm says. “The bivalent vaccine is working as well as we could have expected,” he says, especially in high-risk people and in those over age 65. “The challenge we have is, what does that mean going forward?”
In his review, Dr. Topol concludes: “There is now more than ample, highly consistent evidence via lab studies and clinical outcomes to support the bivalent’s benefit over the original booster.”
Among other evidence, he looked at eight studies, including four that used a live virus as part of the research. Six of the eight studies showed the bivalent booster is more effective against the BA.5 variant, compared with the original booster shots. Two others showed no real difference.
“The four live virus studies offer consistent evidence of broadened immunity for the BA.5 vaccine that is improved over the original booster shots,” Dr. Topol wrote. The evidence also found the bivalent antibody response superior against XBB, he wrote.
Dr. Topol also cited CDC data that supports the benefits of the bivalent shot on hospitalization in older adults. During November, hospitalization of adults 65 and above was 2.5 times higher for those vaccinated who did not get the booster, compared to those who got the updated bivalent booster.
Boosters do matter, Dr. Offit says. “But not for all.” In a perspective published Jan. 11 in the New England Journal of Medicine – the same issue that published the two studies finding few differences between the original and bivalent – Dr. Offit wrote that boosting is best reserved for vulnerable groups.
Chasing the variants with a bivalent vaccine, he says, “has not panned out. There remains no evidence that a bivalent vaccine is any better than what we had. Please, show me the data that one is better than the other.”
Dr. Offit believes the goal should not be to prevent all symptomatic infections in healthy, young people by boosting them “with vaccines containing mRNA from strains that might disappear a few months later.”
The CDC needs to parse the data by subgroups, Dr. Offit says. “The critical question is, ‘Who gets hospitalized and who is dying? Who are they?’ ”
That data should take into account age, ethnicity, vaccine history, and other factors, Dr. Offit says, because right now, there is no great data to say, “OK, everyone gets a boost.”
Future vaccine costs
Another debate – for not only current boosters but future ones, too – centers on cost. Without congressional action to fund more vaccines, vaccine makers have suggested their prices may reach $130 a dose, compared with the average $20-per-dose cost the federal government pays now, according to a Kaiser Family Foundation report.
The government has spent more than $30 billion on COVID-19 vaccines, including the bivalent, to provide them free of charge.
The suggested price increase infuriated many. On Jan. 10, Sen. Bernie Sanders (I-Vt.), incoming chair of the Senate Committee on Health, Education, Labor and Pensions, sent a letter to Moderna CEO Stéphane Bancel, urging him to reconsider and refrain from any price increase.
“The huge increase in price that you have proposed will have a significantly negative impact on the budgets of Medicaid, Medicare and other government programs that will continue covering the vaccine without cost-sharing for patients.”
He pointed out, too, the $19 billion in profits Moderna has made over the past 2 years.
While most people with health insurance would likely still get the vaccines and booster for free, according to the Kaiser analysis, will a higher price discourage people from keeping up with recommended vaccinations, including a possible new booster?
“I think so, yes,” Dr. Hotez says, noting that vaccine reluctance is high as it is, even with free vaccinations and easy access.
“The government is balking at paying for the boosters,” he says. “I think it’s very tone deaf from the pharmaceutical companies [to increase the price]. Given all the help they’ve gotten from the American people, I think they should not be gouging at this point.”
He noted that the federal government provided not just money to the companies for the vaccines, but a “glide path” through the FDA for the vaccine approvals.
Are new, variant-specific boosters coming?
Are Moderna, Pfizer-BioNTech, and others developing more variant-specific vaccines, boosters, or other advances?
Novavax, approved in July 2022 as a primary series and in some cases as a booster, is “also developing an Omicron-containing bivalent vaccine at the direction of public health agencies,” says spokesperson Alison Chartan.
Pfizer responded: “When and if we have something to share we will let you know.”
Moderna did not respond.
A version of this article first appeared on WebMD.com.
Physician sues AMA for defamation over 2022 election controversy
If Willarda Edwards, MD, MBA, had won her 2022 campaign for president-elect of the American Medical Association (AMA), she would have been the second Black woman to head the group.
The lawsuit sheds light on the power dynamics of a politically potent organization that has more than 271,000 members and holds assets of $1.2 billion. The AMA president is one of the most visible figures in American medicine.
“The AMA impugned Dr. Edwards with these false charges, which destroyed her candidacy and irreparably damaged her reputation,” according to the complaint, which was filed Nov. 9, 2022, in Baltimore County Circuit Court. The case was later moved to federal court.
The AMA “previously rejected our attempt to resolve this matter without litigation,” Dr. Edwards’ attorney, Timothy Maloney, told this news organization. An AMA spokesman said the organization had no comment on Dr. Edwards’ suit.
Dr. Edwards is a past president of the National Medical Association, MedChi, the Baltimore City Medical Society, the Monumental City Medical Society, and the Sickle Cell Disease Association of America. She joined the AMA in 1994 and has served as a trustee since 2016.
As chair of the AMA Task Force on Health Equity, “she helped lead the way in consensus building and driving action that in 2019 resulted in the AMA House of Delegates establishing the AMA Center on Health Equity,” according to her AMA bio page.
‘Quid pro quo’ alleged
In June 2022, Dr. Edwards was one of three individuals running to be AMA president-elect.
According to Dr. Edwards’ complaint, she was “incorrectly advised by colleagues” that Virginia urologist William Reha, MD, had decided not to seek the AMA vice-speakership in 2023. This was important because both Dr. Edwards and Dr. Reha were in the Southeastern delegation. It could be in Dr. Edwards’ favor if Dr. Reha was not running, as it would mean one less leadership candidate from the same region.
Dr. Edwards called Dr. Reha on June 6 to discuss the matter. When they talked, Dr. Reha allegedly recorded the call without Dr. Edwards’ knowledge or permission – a felony in Maryland – and also steered her toward discussions about how his decision could benefit her campaign, according to the complaint.
The suit alleges that Dr. Reha’s questions were “clearly calculated to draw some statements by Dr. Edwards that he could use later to thwart her candidacy and to benefit her opponent.”
On June 10, at the AMA’s House of Delegates meeting in Chicago, Dr. Edwards was taken aside and questioned by members of the AMA’s Election Campaign Committee, according to the complaint. They accused her of “vote trading” but did not provide any evidence or a copy of a complaint they said had been filed against her, the suit said.
Dr. Edwards was given no opportunity to produce her own evidence or rebut the accusations, the suit alleges.
Just before the delegates started formal business on June 13, House Speaker Bruce Scott, MD, read a statement to the assembly saying that a complaint of a possible campaign violation had been filed against Dr. Edwards.
Dr. Scott told the delegates that “committee members interviewed the complainant and multiple other individuals said to have knowledge of the circumstances. In addition to conducting multiple interviews, the committee reviewed evidence that was deemed credible and corroborated that a campaign violation did in fact occur,” according to the complaint.
The supposed violation: A “quid pro quo” in which an unnamed delegation would support Dr. Edwards’ current candidacy, and the Southeastern delegation would support a future candidate from that other unnamed delegation.
Dr. Edwards was given a short opportunity to speak, in which she denied any violations.
According to a news report, Dr. Edwards said, “I’ve been in the House of Delegates for 30 years, and you know me as a process person – a person who truly believes in the process and trying to follow the complexities of our election campaign.”
The lawsuit alleges that “this defamatory conduct was repeated the next day to more than 600 delegates just minutes prior to the casting of votes, when Dr Scott repeated these allegations.”
Dr. Edwards lost the election.
AMA: Nothing more to add
The suit alleges that neither the Election Campaign Committee nor the AMA itself has made any accusers or complaints available to Dr. Edwards and that it has not provided any audio or written evidence of her alleged violation.
In July, the AMA’s Southeastern delegation told its membership, “We continue to maintain that Willarda was ‘set up’ ... The whole affair lacked any reasonable semblance of due process.”
The delegation has filed a counter claim against the AMA seeking “to address this lack of due process as well as the reputational harm” to the delegation.
The AMA said that it has nothing it can produce. “The Speaker of the House presented a verbal report to the attending delegates,” said a spokesman. “The Speaker’s report remains the only remarks from an AMA officer, and no additional remarks can be expected at this time.”
He added that there “is no official transcript of the Speaker’s report.”
A version of this article first appeared on Medscape.com.
If Willarda Edwards, MD, MBA, had won her 2022 campaign for president-elect of the American Medical Association (AMA), she would have been the second Black woman to head the group.
The lawsuit sheds light on the power dynamics of a politically potent organization that has more than 271,000 members and holds assets of $1.2 billion. The AMA president is one of the most visible figures in American medicine.
“The AMA impugned Dr. Edwards with these false charges, which destroyed her candidacy and irreparably damaged her reputation,” according to the complaint, which was filed Nov. 9, 2022, in Baltimore County Circuit Court. The case was later moved to federal court.
The AMA “previously rejected our attempt to resolve this matter without litigation,” Dr. Edwards’ attorney, Timothy Maloney, told this news organization. An AMA spokesman said the organization had no comment on Dr. Edwards’ suit.
Dr. Edwards is a past president of the National Medical Association, MedChi, the Baltimore City Medical Society, the Monumental City Medical Society, and the Sickle Cell Disease Association of America. She joined the AMA in 1994 and has served as a trustee since 2016.
As chair of the AMA Task Force on Health Equity, “she helped lead the way in consensus building and driving action that in 2019 resulted in the AMA House of Delegates establishing the AMA Center on Health Equity,” according to her AMA bio page.
‘Quid pro quo’ alleged
In June 2022, Dr. Edwards was one of three individuals running to be AMA president-elect.
According to Dr. Edwards’ complaint, she was “incorrectly advised by colleagues” that Virginia urologist William Reha, MD, had decided not to seek the AMA vice-speakership in 2023. This was important because both Dr. Edwards and Dr. Reha were in the Southeastern delegation. It could be in Dr. Edwards’ favor if Dr. Reha was not running, as it would mean one less leadership candidate from the same region.
Dr. Edwards called Dr. Reha on June 6 to discuss the matter. When they talked, Dr. Reha allegedly recorded the call without Dr. Edwards’ knowledge or permission – a felony in Maryland – and also steered her toward discussions about how his decision could benefit her campaign, according to the complaint.
The suit alleges that Dr. Reha’s questions were “clearly calculated to draw some statements by Dr. Edwards that he could use later to thwart her candidacy and to benefit her opponent.”
On June 10, at the AMA’s House of Delegates meeting in Chicago, Dr. Edwards was taken aside and questioned by members of the AMA’s Election Campaign Committee, according to the complaint. They accused her of “vote trading” but did not provide any evidence or a copy of a complaint they said had been filed against her, the suit said.
Dr. Edwards was given no opportunity to produce her own evidence or rebut the accusations, the suit alleges.
Just before the delegates started formal business on June 13, House Speaker Bruce Scott, MD, read a statement to the assembly saying that a complaint of a possible campaign violation had been filed against Dr. Edwards.
Dr. Scott told the delegates that “committee members interviewed the complainant and multiple other individuals said to have knowledge of the circumstances. In addition to conducting multiple interviews, the committee reviewed evidence that was deemed credible and corroborated that a campaign violation did in fact occur,” according to the complaint.
The supposed violation: A “quid pro quo” in which an unnamed delegation would support Dr. Edwards’ current candidacy, and the Southeastern delegation would support a future candidate from that other unnamed delegation.
Dr. Edwards was given a short opportunity to speak, in which she denied any violations.
According to a news report, Dr. Edwards said, “I’ve been in the House of Delegates for 30 years, and you know me as a process person – a person who truly believes in the process and trying to follow the complexities of our election campaign.”
The lawsuit alleges that “this defamatory conduct was repeated the next day to more than 600 delegates just minutes prior to the casting of votes, when Dr Scott repeated these allegations.”
Dr. Edwards lost the election.
AMA: Nothing more to add
The suit alleges that neither the Election Campaign Committee nor the AMA itself has made any accusers or complaints available to Dr. Edwards and that it has not provided any audio or written evidence of her alleged violation.
In July, the AMA’s Southeastern delegation told its membership, “We continue to maintain that Willarda was ‘set up’ ... The whole affair lacked any reasonable semblance of due process.”
The delegation has filed a counter claim against the AMA seeking “to address this lack of due process as well as the reputational harm” to the delegation.
The AMA said that it has nothing it can produce. “The Speaker of the House presented a verbal report to the attending delegates,” said a spokesman. “The Speaker’s report remains the only remarks from an AMA officer, and no additional remarks can be expected at this time.”
He added that there “is no official transcript of the Speaker’s report.”
A version of this article first appeared on Medscape.com.
If Willarda Edwards, MD, MBA, had won her 2022 campaign for president-elect of the American Medical Association (AMA), she would have been the second Black woman to head the group.
The lawsuit sheds light on the power dynamics of a politically potent organization that has more than 271,000 members and holds assets of $1.2 billion. The AMA president is one of the most visible figures in American medicine.
“The AMA impugned Dr. Edwards with these false charges, which destroyed her candidacy and irreparably damaged her reputation,” according to the complaint, which was filed Nov. 9, 2022, in Baltimore County Circuit Court. The case was later moved to federal court.
The AMA “previously rejected our attempt to resolve this matter without litigation,” Dr. Edwards’ attorney, Timothy Maloney, told this news organization. An AMA spokesman said the organization had no comment on Dr. Edwards’ suit.
Dr. Edwards is a past president of the National Medical Association, MedChi, the Baltimore City Medical Society, the Monumental City Medical Society, and the Sickle Cell Disease Association of America. She joined the AMA in 1994 and has served as a trustee since 2016.
As chair of the AMA Task Force on Health Equity, “she helped lead the way in consensus building and driving action that in 2019 resulted in the AMA House of Delegates establishing the AMA Center on Health Equity,” according to her AMA bio page.
‘Quid pro quo’ alleged
In June 2022, Dr. Edwards was one of three individuals running to be AMA president-elect.
According to Dr. Edwards’ complaint, she was “incorrectly advised by colleagues” that Virginia urologist William Reha, MD, had decided not to seek the AMA vice-speakership in 2023. This was important because both Dr. Edwards and Dr. Reha were in the Southeastern delegation. It could be in Dr. Edwards’ favor if Dr. Reha was not running, as it would mean one less leadership candidate from the same region.
Dr. Edwards called Dr. Reha on June 6 to discuss the matter. When they talked, Dr. Reha allegedly recorded the call without Dr. Edwards’ knowledge or permission – a felony in Maryland – and also steered her toward discussions about how his decision could benefit her campaign, according to the complaint.
The suit alleges that Dr. Reha’s questions were “clearly calculated to draw some statements by Dr. Edwards that he could use later to thwart her candidacy and to benefit her opponent.”
On June 10, at the AMA’s House of Delegates meeting in Chicago, Dr. Edwards was taken aside and questioned by members of the AMA’s Election Campaign Committee, according to the complaint. They accused her of “vote trading” but did not provide any evidence or a copy of a complaint they said had been filed against her, the suit said.
Dr. Edwards was given no opportunity to produce her own evidence or rebut the accusations, the suit alleges.
Just before the delegates started formal business on June 13, House Speaker Bruce Scott, MD, read a statement to the assembly saying that a complaint of a possible campaign violation had been filed against Dr. Edwards.
Dr. Scott told the delegates that “committee members interviewed the complainant and multiple other individuals said to have knowledge of the circumstances. In addition to conducting multiple interviews, the committee reviewed evidence that was deemed credible and corroborated that a campaign violation did in fact occur,” according to the complaint.
The supposed violation: A “quid pro quo” in which an unnamed delegation would support Dr. Edwards’ current candidacy, and the Southeastern delegation would support a future candidate from that other unnamed delegation.
Dr. Edwards was given a short opportunity to speak, in which she denied any violations.
According to a news report, Dr. Edwards said, “I’ve been in the House of Delegates for 30 years, and you know me as a process person – a person who truly believes in the process and trying to follow the complexities of our election campaign.”
The lawsuit alleges that “this defamatory conduct was repeated the next day to more than 600 delegates just minutes prior to the casting of votes, when Dr Scott repeated these allegations.”
Dr. Edwards lost the election.
AMA: Nothing more to add
The suit alleges that neither the Election Campaign Committee nor the AMA itself has made any accusers or complaints available to Dr. Edwards and that it has not provided any audio or written evidence of her alleged violation.
In July, the AMA’s Southeastern delegation told its membership, “We continue to maintain that Willarda was ‘set up’ ... The whole affair lacked any reasonable semblance of due process.”
The delegation has filed a counter claim against the AMA seeking “to address this lack of due process as well as the reputational harm” to the delegation.
The AMA said that it has nothing it can produce. “The Speaker of the House presented a verbal report to the attending delegates,” said a spokesman. “The Speaker’s report remains the only remarks from an AMA officer, and no additional remarks can be expected at this time.”
He added that there “is no official transcript of the Speaker’s report.”
A version of this article first appeared on Medscape.com.
Will your smartphone be the next doctor’s office?
A fingertip pressed against a phone’s camera lens can measure a heart rate. The microphone, kept by the bedside, can screen for sleep apnea. Even the speaker is being tapped, to monitor breathing using sonar technology.
In the best of this new world, the data is conveyed remotely to a medical professional for the convenience and comfort of the patient or, in some cases, to support a clinician without the need for costly hardware.
But using smartphones as diagnostic tools is a work in progress, experts say. Although doctors and their patients have found some real-world success in deploying the phone as a medical device, the overall potential remains unfulfilled and uncertain.
Smartphones come packed with sensors capable of monitoring a patient’s vital signs. They can help assess people for concussions, watch for atrial fibrillation, and conduct mental health wellness checks, to name the uses of a few nascent applications.
Companies and researchers eager to find medical applications for smartphone technology are tapping into modern phones’ built-in cameras and light sensors; microphones; accelerometers, which detect body movements; gyroscopes; and even speakers. The apps then use artificial intelligence software to analyze the collected sights and sounds to create an easy connection between patients and physicians. Earning potential and marketability are evidenced by the more than 350,000 digital health products available in app stores, according to a Grand View Research report.
“It’s very hard to put devices into the patient home or in the hospital, but everybody is just walking around with a cellphone that has a network connection,” said Dr. Andrew Gostine, CEO of the sensor network company Artisight. Most Americans own a smartphone, including more than 60% of people 65 and over, an increase from just 13% a decade ago, according the Pew Research Center. The COVID-19 pandemic has also pushed people to become more comfortable with virtual care.
Some of these products have sought FDA clearance to be marketed as a medical device. That way, if patients must pay to use the software, health insurers are more likely to cover at least part of the cost. Other products are designated as exempt from this regulatory process, placed in the same clinical classification as a Band-Aid. But how the agency handles AI and machine learning–based medical devices is still being adjusted to reflect software’s adaptive nature.
Ensuring accuracy and clinical validation is crucial to securing buy-in from health care providers. And many tools still need fine-tuning, said Eugene Yang, MD, a professor of medicine at the University of Washington, Seattle. Currently, Dr. Yang is testing contactless measurement of blood pressure, heart rate, and oxygen saturation gleaned remotely via Zoom camera footage of a patient’s face.
Judging these new technologies is difficult because they rely on algorithms built by machine learning and artificial intelligence to collect data, rather than the physical tools typically used in hospitals. So researchers cannot “compare apples to apples” with medical industry standards, Dr. Yang said. Failure to build in such assurances undermines the technology’s ultimate goals of easing costs and access because a doctor still must verify results.
“False positives and false negatives lead to more testing and more cost to the health care system,” he said.
Big tech companies like Google have heavily invested in researching this kind of technology, catering to clinicians and in-home caregivers, as well as consumers. Currently, in the Google Fit app, users can check their heart rate by placing their finger on the rear-facing camera lens or track their breathing rate using the front-facing camera.
“If you took the sensor out of the phone and out of a clinical device, they are probably the same thing,” said Shwetak Patel, director of health technologies at Google and a professor of electrical and computer engineering at the University of Washington.
Google’s research uses machine learning and computer vision, a field within AI based on information from visual inputs like videos or images. So instead of using a blood pressure cuff, for example, the algorithm can interpret slight visual changes to the body that serve as proxies and biosignals for a patient’s blood pressure, Mr. Patel said.
Google is also investigating the effectiveness of the built-in microphone for detecting heartbeats and murmurs and using the camera to preserve eyesight by screening for diabetic eye disease, according to information the company published last year.
The tech giant recently purchased Sound Life Sciences, a Seattle startup with an FDA-cleared sonar technology app. It uses a smart device’s speaker to bounce inaudible pulses off a patient’s body to identify movement and monitor breathing.
Binah.ai, based in Israel, is another company using the smartphone camera to calculate vital signs. Its software looks at the region around the eyes, where the skin is a bit thinner, and analyzes the light reflecting off blood vessels back to the lens. The company is wrapping up a U.S. clinical trial and marketing its wellness app directly to insurers and other health companies, said company spokesperson Mona Popilian-Yona.
The applications even reach into disciplines such as optometry and mental health:
- With the microphone, Canary Speech uses the same underlying technology as Amazon’s Alexa to analyze patients’ voices for mental health conditions. The software can integrate with telemedicine appointments and allow clinicians to screen for anxiety and depression using a library of vocal biomarkers and predictive analytics, said Henry O’Connell, the company’s CEO.
- Australia-based ResApp Health last year for its iPhone app that screens for moderate to severe obstructive sleep apnea by listening to breathing and snoring. SleepCheckRx, which will require a prescription, is minimally invasive compared with sleep studies currently used to diagnose sleep apnea. Those can cost thousands of dollars and require an array of tests.
- Brightlamp’s Reflex app is a clinical decision support tool for helping manage concussions and vision rehabilitation, among other things. Using an iPad’s or iPhone’s camera, the mobile app measures how a person’s pupils react to changes in light. Through machine learning analysis, the imagery gives practitioners data points for evaluating patients. Brightlamp sells directly to health care providers and is being used in more than 230 clinics. Clinicians pay a $400 standard annual fee per account, which is currently not covered by insurance. The Department of Defense has an ongoing clinical trial using Reflex.
In some cases, such as with the Reflex app, the data is processed directly on the phone – rather than in the cloud, Brightlamp CEO Kurtis Sluss said. By processing everything on the device, the app avoids running into privacy issues, as streaming data elsewhere requires patient consent.
But algorithms need to be trained and tested by collecting reams of data, and that is an ongoing process.
Researchers, for example, have found that some computer vision applications, like heart rate or blood pressure monitoring, can be less accurate for darker skin. Studies are underway to find better solutions.
Small algorithm glitches can also produce false alarms and frighten patients enough to keep widespread adoption out of reach. For example, Apple’s new car-crash detection feature, available on both the latest iPhone and Apple Watch, was set off when people were riding roller coasters and automatically dialed 911.
“We’re not there yet,” Dr. Yang said. “That’s the bottom line.”
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
A fingertip pressed against a phone’s camera lens can measure a heart rate. The microphone, kept by the bedside, can screen for sleep apnea. Even the speaker is being tapped, to monitor breathing using sonar technology.
In the best of this new world, the data is conveyed remotely to a medical professional for the convenience and comfort of the patient or, in some cases, to support a clinician without the need for costly hardware.
But using smartphones as diagnostic tools is a work in progress, experts say. Although doctors and their patients have found some real-world success in deploying the phone as a medical device, the overall potential remains unfulfilled and uncertain.
Smartphones come packed with sensors capable of monitoring a patient’s vital signs. They can help assess people for concussions, watch for atrial fibrillation, and conduct mental health wellness checks, to name the uses of a few nascent applications.
Companies and researchers eager to find medical applications for smartphone technology are tapping into modern phones’ built-in cameras and light sensors; microphones; accelerometers, which detect body movements; gyroscopes; and even speakers. The apps then use artificial intelligence software to analyze the collected sights and sounds to create an easy connection between patients and physicians. Earning potential and marketability are evidenced by the more than 350,000 digital health products available in app stores, according to a Grand View Research report.
“It’s very hard to put devices into the patient home or in the hospital, but everybody is just walking around with a cellphone that has a network connection,” said Dr. Andrew Gostine, CEO of the sensor network company Artisight. Most Americans own a smartphone, including more than 60% of people 65 and over, an increase from just 13% a decade ago, according the Pew Research Center. The COVID-19 pandemic has also pushed people to become more comfortable with virtual care.
Some of these products have sought FDA clearance to be marketed as a medical device. That way, if patients must pay to use the software, health insurers are more likely to cover at least part of the cost. Other products are designated as exempt from this regulatory process, placed in the same clinical classification as a Band-Aid. But how the agency handles AI and machine learning–based medical devices is still being adjusted to reflect software’s adaptive nature.
Ensuring accuracy and clinical validation is crucial to securing buy-in from health care providers. And many tools still need fine-tuning, said Eugene Yang, MD, a professor of medicine at the University of Washington, Seattle. Currently, Dr. Yang is testing contactless measurement of blood pressure, heart rate, and oxygen saturation gleaned remotely via Zoom camera footage of a patient’s face.
Judging these new technologies is difficult because they rely on algorithms built by machine learning and artificial intelligence to collect data, rather than the physical tools typically used in hospitals. So researchers cannot “compare apples to apples” with medical industry standards, Dr. Yang said. Failure to build in such assurances undermines the technology’s ultimate goals of easing costs and access because a doctor still must verify results.
“False positives and false negatives lead to more testing and more cost to the health care system,” he said.
Big tech companies like Google have heavily invested in researching this kind of technology, catering to clinicians and in-home caregivers, as well as consumers. Currently, in the Google Fit app, users can check their heart rate by placing their finger on the rear-facing camera lens or track their breathing rate using the front-facing camera.
“If you took the sensor out of the phone and out of a clinical device, they are probably the same thing,” said Shwetak Patel, director of health technologies at Google and a professor of electrical and computer engineering at the University of Washington.
Google’s research uses machine learning and computer vision, a field within AI based on information from visual inputs like videos or images. So instead of using a blood pressure cuff, for example, the algorithm can interpret slight visual changes to the body that serve as proxies and biosignals for a patient’s blood pressure, Mr. Patel said.
Google is also investigating the effectiveness of the built-in microphone for detecting heartbeats and murmurs and using the camera to preserve eyesight by screening for diabetic eye disease, according to information the company published last year.
The tech giant recently purchased Sound Life Sciences, a Seattle startup with an FDA-cleared sonar technology app. It uses a smart device’s speaker to bounce inaudible pulses off a patient’s body to identify movement and monitor breathing.
Binah.ai, based in Israel, is another company using the smartphone camera to calculate vital signs. Its software looks at the region around the eyes, where the skin is a bit thinner, and analyzes the light reflecting off blood vessels back to the lens. The company is wrapping up a U.S. clinical trial and marketing its wellness app directly to insurers and other health companies, said company spokesperson Mona Popilian-Yona.
The applications even reach into disciplines such as optometry and mental health:
- With the microphone, Canary Speech uses the same underlying technology as Amazon’s Alexa to analyze patients’ voices for mental health conditions. The software can integrate with telemedicine appointments and allow clinicians to screen for anxiety and depression using a library of vocal biomarkers and predictive analytics, said Henry O’Connell, the company’s CEO.
- Australia-based ResApp Health last year for its iPhone app that screens for moderate to severe obstructive sleep apnea by listening to breathing and snoring. SleepCheckRx, which will require a prescription, is minimally invasive compared with sleep studies currently used to diagnose sleep apnea. Those can cost thousands of dollars and require an array of tests.
- Brightlamp’s Reflex app is a clinical decision support tool for helping manage concussions and vision rehabilitation, among other things. Using an iPad’s or iPhone’s camera, the mobile app measures how a person’s pupils react to changes in light. Through machine learning analysis, the imagery gives practitioners data points for evaluating patients. Brightlamp sells directly to health care providers and is being used in more than 230 clinics. Clinicians pay a $400 standard annual fee per account, which is currently not covered by insurance. The Department of Defense has an ongoing clinical trial using Reflex.
In some cases, such as with the Reflex app, the data is processed directly on the phone – rather than in the cloud, Brightlamp CEO Kurtis Sluss said. By processing everything on the device, the app avoids running into privacy issues, as streaming data elsewhere requires patient consent.
But algorithms need to be trained and tested by collecting reams of data, and that is an ongoing process.
Researchers, for example, have found that some computer vision applications, like heart rate or blood pressure monitoring, can be less accurate for darker skin. Studies are underway to find better solutions.
Small algorithm glitches can also produce false alarms and frighten patients enough to keep widespread adoption out of reach. For example, Apple’s new car-crash detection feature, available on both the latest iPhone and Apple Watch, was set off when people were riding roller coasters and automatically dialed 911.
“We’re not there yet,” Dr. Yang said. “That’s the bottom line.”
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.
A fingertip pressed against a phone’s camera lens can measure a heart rate. The microphone, kept by the bedside, can screen for sleep apnea. Even the speaker is being tapped, to monitor breathing using sonar technology.
In the best of this new world, the data is conveyed remotely to a medical professional for the convenience and comfort of the patient or, in some cases, to support a clinician without the need for costly hardware.
But using smartphones as diagnostic tools is a work in progress, experts say. Although doctors and their patients have found some real-world success in deploying the phone as a medical device, the overall potential remains unfulfilled and uncertain.
Smartphones come packed with sensors capable of monitoring a patient’s vital signs. They can help assess people for concussions, watch for atrial fibrillation, and conduct mental health wellness checks, to name the uses of a few nascent applications.
Companies and researchers eager to find medical applications for smartphone technology are tapping into modern phones’ built-in cameras and light sensors; microphones; accelerometers, which detect body movements; gyroscopes; and even speakers. The apps then use artificial intelligence software to analyze the collected sights and sounds to create an easy connection between patients and physicians. Earning potential and marketability are evidenced by the more than 350,000 digital health products available in app stores, according to a Grand View Research report.
“It’s very hard to put devices into the patient home or in the hospital, but everybody is just walking around with a cellphone that has a network connection,” said Dr. Andrew Gostine, CEO of the sensor network company Artisight. Most Americans own a smartphone, including more than 60% of people 65 and over, an increase from just 13% a decade ago, according the Pew Research Center. The COVID-19 pandemic has also pushed people to become more comfortable with virtual care.
Some of these products have sought FDA clearance to be marketed as a medical device. That way, if patients must pay to use the software, health insurers are more likely to cover at least part of the cost. Other products are designated as exempt from this regulatory process, placed in the same clinical classification as a Band-Aid. But how the agency handles AI and machine learning–based medical devices is still being adjusted to reflect software’s adaptive nature.
Ensuring accuracy and clinical validation is crucial to securing buy-in from health care providers. And many tools still need fine-tuning, said Eugene Yang, MD, a professor of medicine at the University of Washington, Seattle. Currently, Dr. Yang is testing contactless measurement of blood pressure, heart rate, and oxygen saturation gleaned remotely via Zoom camera footage of a patient’s face.
Judging these new technologies is difficult because they rely on algorithms built by machine learning and artificial intelligence to collect data, rather than the physical tools typically used in hospitals. So researchers cannot “compare apples to apples” with medical industry standards, Dr. Yang said. Failure to build in such assurances undermines the technology’s ultimate goals of easing costs and access because a doctor still must verify results.
“False positives and false negatives lead to more testing and more cost to the health care system,” he said.
Big tech companies like Google have heavily invested in researching this kind of technology, catering to clinicians and in-home caregivers, as well as consumers. Currently, in the Google Fit app, users can check their heart rate by placing their finger on the rear-facing camera lens or track their breathing rate using the front-facing camera.
“If you took the sensor out of the phone and out of a clinical device, they are probably the same thing,” said Shwetak Patel, director of health technologies at Google and a professor of electrical and computer engineering at the University of Washington.
Google’s research uses machine learning and computer vision, a field within AI based on information from visual inputs like videos or images. So instead of using a blood pressure cuff, for example, the algorithm can interpret slight visual changes to the body that serve as proxies and biosignals for a patient’s blood pressure, Mr. Patel said.
Google is also investigating the effectiveness of the built-in microphone for detecting heartbeats and murmurs and using the camera to preserve eyesight by screening for diabetic eye disease, according to information the company published last year.
The tech giant recently purchased Sound Life Sciences, a Seattle startup with an FDA-cleared sonar technology app. It uses a smart device’s speaker to bounce inaudible pulses off a patient’s body to identify movement and monitor breathing.
Binah.ai, based in Israel, is another company using the smartphone camera to calculate vital signs. Its software looks at the region around the eyes, where the skin is a bit thinner, and analyzes the light reflecting off blood vessels back to the lens. The company is wrapping up a U.S. clinical trial and marketing its wellness app directly to insurers and other health companies, said company spokesperson Mona Popilian-Yona.
The applications even reach into disciplines such as optometry and mental health:
- With the microphone, Canary Speech uses the same underlying technology as Amazon’s Alexa to analyze patients’ voices for mental health conditions. The software can integrate with telemedicine appointments and allow clinicians to screen for anxiety and depression using a library of vocal biomarkers and predictive analytics, said Henry O’Connell, the company’s CEO.
- Australia-based ResApp Health last year for its iPhone app that screens for moderate to severe obstructive sleep apnea by listening to breathing and snoring. SleepCheckRx, which will require a prescription, is minimally invasive compared with sleep studies currently used to diagnose sleep apnea. Those can cost thousands of dollars and require an array of tests.
- Brightlamp’s Reflex app is a clinical decision support tool for helping manage concussions and vision rehabilitation, among other things. Using an iPad’s or iPhone’s camera, the mobile app measures how a person’s pupils react to changes in light. Through machine learning analysis, the imagery gives practitioners data points for evaluating patients. Brightlamp sells directly to health care providers and is being used in more than 230 clinics. Clinicians pay a $400 standard annual fee per account, which is currently not covered by insurance. The Department of Defense has an ongoing clinical trial using Reflex.
In some cases, such as with the Reflex app, the data is processed directly on the phone – rather than in the cloud, Brightlamp CEO Kurtis Sluss said. By processing everything on the device, the app avoids running into privacy issues, as streaming data elsewhere requires patient consent.
But algorithms need to be trained and tested by collecting reams of data, and that is an ongoing process.
Researchers, for example, have found that some computer vision applications, like heart rate or blood pressure monitoring, can be less accurate for darker skin. Studies are underway to find better solutions.
Small algorithm glitches can also produce false alarms and frighten patients enough to keep widespread adoption out of reach. For example, Apple’s new car-crash detection feature, available on both the latest iPhone and Apple Watch, was set off when people were riding roller coasters and automatically dialed 911.
“We’re not there yet,” Dr. Yang said. “That’s the bottom line.”
KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.