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Rivaroxaban’s single daily dose may lead to higher bleeding risk than other DOACs
The results, which were published in the Annals of Internal Medicine, could help guide DOAC selection for high-risk groups with a prior history of peptic ulcer disease or major GI bleeding, said lead study authors Arnar Bragi Ingason, MD and Einar S. Björnsson, MD, PhD, in an email.
DOACs treat conditions such as atrial fibrillation, venous thromboembolism, and ischemic stroke and are known to cause GI bleeding. Previous studies have suggested that rivaroxaban poses a higher GI-bleeding risk than other DOACs.
These studies, which used large administrative databases, “had an inherent risk of selection bias due to insurance status, age, and comorbidities due to their origin from insurance/administrative databases. In addition, they lacked phenotypic details on GI bleeding events,” said Dr. Björnsson and Dr. Ingason, who are both of Landspitali University Hospital, Reykjavik, Iceland,
Daily dosage may exacerbate risk
Rivaroxaban is administered as a single daily dose, compared with apixaban’s and dabigatran’s twice-daily regimens. “We hypothesized that this may lead to a greater variance in drug plasma concentration, making these patients more susceptible to GI bleeding,” the lead authors said.
Using data from the Icelandic Medicine Registry, a national database of outpatient prescription information, they compared rates of GI bleeding among new users of apixaban, dabigatran, and rivaroxaban from 2014 to 2019. Overall, 5,868 patients receiving one of the DOACs took part in the study. Among these participants, 3,217 received rivaroxaban, 2,157 received apixaban, and 494 received dabigatran. The researchers used inverse probability weighting, Kaplan–Meier survival estimates, and Cox regression to compare GI bleeding.
Compared with dabigatran, rivaroxaban was associated with a 63%-104% higher overall risk for GI bleeding and 39%-95% higher risk for major GI bleeding. Rivaroxaban also had a 40%-42% higher overall risk for GI bleeding and 49%-50% higher risk for major GI bleeding, compared with apixaban.
The investigators were surprised by the low rate of upper GI bleeding for dabigatran, compared with the other two drugs. “However, these results must be interpreted in the context that the dabigatran group was relatively small,” said Dr. Björnsson and Dr. Ingason via email.
Overall, the study cohort was small, compared with previous registry studies.
Investigators also did not account for account for socioeconomic status or lifestyle factors, such as alcohol consumption or smoking. “However, because the cost of all DOACs is similar in Iceland, selection bias due to socioeconomic status is unlikely,” the investigators reported in their paper. “We are currently working on comparing the rates of thromboembolisms and overall major bleeding events between the drugs,” the lead authors said.
Clinicians should consider location of bleeding
Though retrospective, the study by Ingason et. al. “is likely as close as is feasible to a randomized trial as is possible,” said Don C. Rockey, MD, a professor of medicine at the Medical University of South Carolina, Charleston, in an interview.
“From the clinician’s perspective, it is important to take away that there may be differences among the DOACs in terms of where in the GI tract the bleeding occurs,” said Dr. Rockey. In the study, the greatest differences appeared to be in the upper GI tract, with rivaroxaban outpacing apixaban and dabigatran. In patients who are at risk for upper GI bleeding, it may be reasonable to consider use of dabigatran or apixaban, he suggested.
“A limitation of the study is that it is likely underpowered overall,” said Dr. Rockey. It also wasn’t clear how many deaths occurred either directly from GI bleeding or as a complication of GI bleeding, he said.The study also didn’t differentiate major bleeding among DOACs specifically in the upper or lower GI tract, Dr. Rockey added.
Other studies yield similar results
Dr. Ingason and Dr. Björnsson said their work complements previous studies, and Neena S. Abraham, MD, MSc , who has conducted a similar investigation to the new study, agreed with that statement.
Data from the last 4 years overwhelmingly show that rivaroxaban is most likely to cause GI bleeding, said Dr. Abraham, professor of medicine and a consultant with Mayo Clinic’s division of gastroenterology and hepatology, in an interview.
A comparative safety study Dr. Abraham coauthored in 2017 of rivaroxaban, apixaban, and dabigatran in a much larger U.S. cohort of 372,380 patients revealed that rivaroxaban had the worst GI bleeding profile. Apixaban was 66% safer than rivaroxaban and 64% safer than dabigatran to prevent gastrointestinal bleeding.
“I believe our group was the first to conduct this study and show clinically significant differences in GI safety of the available direct oral anticoagulants,” she said. Other investigators have since published similar results, and the topic of the new study needs no further investigation, according to Dr. Abraham.
“It is time for physicians to choose a better choice when prescribing a direct oral anticoagulant to their atrial fibrillation patients, and that choice is not rivaroxaban,” she said.
The Icelandic Centre for Research and the Landspítali University Hospital Research Fund provided funds for this study. Dr. Ingason, Dr. Björnsson, Dr. Rockey, and Dr. Abraham reported no disclosures.
The results, which were published in the Annals of Internal Medicine, could help guide DOAC selection for high-risk groups with a prior history of peptic ulcer disease or major GI bleeding, said lead study authors Arnar Bragi Ingason, MD and Einar S. Björnsson, MD, PhD, in an email.
DOACs treat conditions such as atrial fibrillation, venous thromboembolism, and ischemic stroke and are known to cause GI bleeding. Previous studies have suggested that rivaroxaban poses a higher GI-bleeding risk than other DOACs.
These studies, which used large administrative databases, “had an inherent risk of selection bias due to insurance status, age, and comorbidities due to their origin from insurance/administrative databases. In addition, they lacked phenotypic details on GI bleeding events,” said Dr. Björnsson and Dr. Ingason, who are both of Landspitali University Hospital, Reykjavik, Iceland,
Daily dosage may exacerbate risk
Rivaroxaban is administered as a single daily dose, compared with apixaban’s and dabigatran’s twice-daily regimens. “We hypothesized that this may lead to a greater variance in drug plasma concentration, making these patients more susceptible to GI bleeding,” the lead authors said.
Using data from the Icelandic Medicine Registry, a national database of outpatient prescription information, they compared rates of GI bleeding among new users of apixaban, dabigatran, and rivaroxaban from 2014 to 2019. Overall, 5,868 patients receiving one of the DOACs took part in the study. Among these participants, 3,217 received rivaroxaban, 2,157 received apixaban, and 494 received dabigatran. The researchers used inverse probability weighting, Kaplan–Meier survival estimates, and Cox regression to compare GI bleeding.
Compared with dabigatran, rivaroxaban was associated with a 63%-104% higher overall risk for GI bleeding and 39%-95% higher risk for major GI bleeding. Rivaroxaban also had a 40%-42% higher overall risk for GI bleeding and 49%-50% higher risk for major GI bleeding, compared with apixaban.
The investigators were surprised by the low rate of upper GI bleeding for dabigatran, compared with the other two drugs. “However, these results must be interpreted in the context that the dabigatran group was relatively small,” said Dr. Björnsson and Dr. Ingason via email.
Overall, the study cohort was small, compared with previous registry studies.
Investigators also did not account for account for socioeconomic status or lifestyle factors, such as alcohol consumption or smoking. “However, because the cost of all DOACs is similar in Iceland, selection bias due to socioeconomic status is unlikely,” the investigators reported in their paper. “We are currently working on comparing the rates of thromboembolisms and overall major bleeding events between the drugs,” the lead authors said.
Clinicians should consider location of bleeding
Though retrospective, the study by Ingason et. al. “is likely as close as is feasible to a randomized trial as is possible,” said Don C. Rockey, MD, a professor of medicine at the Medical University of South Carolina, Charleston, in an interview.
“From the clinician’s perspective, it is important to take away that there may be differences among the DOACs in terms of where in the GI tract the bleeding occurs,” said Dr. Rockey. In the study, the greatest differences appeared to be in the upper GI tract, with rivaroxaban outpacing apixaban and dabigatran. In patients who are at risk for upper GI bleeding, it may be reasonable to consider use of dabigatran or apixaban, he suggested.
“A limitation of the study is that it is likely underpowered overall,” said Dr. Rockey. It also wasn’t clear how many deaths occurred either directly from GI bleeding or as a complication of GI bleeding, he said.The study also didn’t differentiate major bleeding among DOACs specifically in the upper or lower GI tract, Dr. Rockey added.
Other studies yield similar results
Dr. Ingason and Dr. Björnsson said their work complements previous studies, and Neena S. Abraham, MD, MSc , who has conducted a similar investigation to the new study, agreed with that statement.
Data from the last 4 years overwhelmingly show that rivaroxaban is most likely to cause GI bleeding, said Dr. Abraham, professor of medicine and a consultant with Mayo Clinic’s division of gastroenterology and hepatology, in an interview.
A comparative safety study Dr. Abraham coauthored in 2017 of rivaroxaban, apixaban, and dabigatran in a much larger U.S. cohort of 372,380 patients revealed that rivaroxaban had the worst GI bleeding profile. Apixaban was 66% safer than rivaroxaban and 64% safer than dabigatran to prevent gastrointestinal bleeding.
“I believe our group was the first to conduct this study and show clinically significant differences in GI safety of the available direct oral anticoagulants,” she said. Other investigators have since published similar results, and the topic of the new study needs no further investigation, according to Dr. Abraham.
“It is time for physicians to choose a better choice when prescribing a direct oral anticoagulant to their atrial fibrillation patients, and that choice is not rivaroxaban,” she said.
The Icelandic Centre for Research and the Landspítali University Hospital Research Fund provided funds for this study. Dr. Ingason, Dr. Björnsson, Dr. Rockey, and Dr. Abraham reported no disclosures.
The results, which were published in the Annals of Internal Medicine, could help guide DOAC selection for high-risk groups with a prior history of peptic ulcer disease or major GI bleeding, said lead study authors Arnar Bragi Ingason, MD and Einar S. Björnsson, MD, PhD, in an email.
DOACs treat conditions such as atrial fibrillation, venous thromboembolism, and ischemic stroke and are known to cause GI bleeding. Previous studies have suggested that rivaroxaban poses a higher GI-bleeding risk than other DOACs.
These studies, which used large administrative databases, “had an inherent risk of selection bias due to insurance status, age, and comorbidities due to their origin from insurance/administrative databases. In addition, they lacked phenotypic details on GI bleeding events,” said Dr. Björnsson and Dr. Ingason, who are both of Landspitali University Hospital, Reykjavik, Iceland,
Daily dosage may exacerbate risk
Rivaroxaban is administered as a single daily dose, compared with apixaban’s and dabigatran’s twice-daily regimens. “We hypothesized that this may lead to a greater variance in drug plasma concentration, making these patients more susceptible to GI bleeding,” the lead authors said.
Using data from the Icelandic Medicine Registry, a national database of outpatient prescription information, they compared rates of GI bleeding among new users of apixaban, dabigatran, and rivaroxaban from 2014 to 2019. Overall, 5,868 patients receiving one of the DOACs took part in the study. Among these participants, 3,217 received rivaroxaban, 2,157 received apixaban, and 494 received dabigatran. The researchers used inverse probability weighting, Kaplan–Meier survival estimates, and Cox regression to compare GI bleeding.
Compared with dabigatran, rivaroxaban was associated with a 63%-104% higher overall risk for GI bleeding and 39%-95% higher risk for major GI bleeding. Rivaroxaban also had a 40%-42% higher overall risk for GI bleeding and 49%-50% higher risk for major GI bleeding, compared with apixaban.
The investigators were surprised by the low rate of upper GI bleeding for dabigatran, compared with the other two drugs. “However, these results must be interpreted in the context that the dabigatran group was relatively small,” said Dr. Björnsson and Dr. Ingason via email.
Overall, the study cohort was small, compared with previous registry studies.
Investigators also did not account for account for socioeconomic status or lifestyle factors, such as alcohol consumption or smoking. “However, because the cost of all DOACs is similar in Iceland, selection bias due to socioeconomic status is unlikely,” the investigators reported in their paper. “We are currently working on comparing the rates of thromboembolisms and overall major bleeding events between the drugs,” the lead authors said.
Clinicians should consider location of bleeding
Though retrospective, the study by Ingason et. al. “is likely as close as is feasible to a randomized trial as is possible,” said Don C. Rockey, MD, a professor of medicine at the Medical University of South Carolina, Charleston, in an interview.
“From the clinician’s perspective, it is important to take away that there may be differences among the DOACs in terms of where in the GI tract the bleeding occurs,” said Dr. Rockey. In the study, the greatest differences appeared to be in the upper GI tract, with rivaroxaban outpacing apixaban and dabigatran. In patients who are at risk for upper GI bleeding, it may be reasonable to consider use of dabigatran or apixaban, he suggested.
“A limitation of the study is that it is likely underpowered overall,” said Dr. Rockey. It also wasn’t clear how many deaths occurred either directly from GI bleeding or as a complication of GI bleeding, he said.The study also didn’t differentiate major bleeding among DOACs specifically in the upper or lower GI tract, Dr. Rockey added.
Other studies yield similar results
Dr. Ingason and Dr. Björnsson said their work complements previous studies, and Neena S. Abraham, MD, MSc , who has conducted a similar investigation to the new study, agreed with that statement.
Data from the last 4 years overwhelmingly show that rivaroxaban is most likely to cause GI bleeding, said Dr. Abraham, professor of medicine and a consultant with Mayo Clinic’s division of gastroenterology and hepatology, in an interview.
A comparative safety study Dr. Abraham coauthored in 2017 of rivaroxaban, apixaban, and dabigatran in a much larger U.S. cohort of 372,380 patients revealed that rivaroxaban had the worst GI bleeding profile. Apixaban was 66% safer than rivaroxaban and 64% safer than dabigatran to prevent gastrointestinal bleeding.
“I believe our group was the first to conduct this study and show clinically significant differences in GI safety of the available direct oral anticoagulants,” she said. Other investigators have since published similar results, and the topic of the new study needs no further investigation, according to Dr. Abraham.
“It is time for physicians to choose a better choice when prescribing a direct oral anticoagulant to their atrial fibrillation patients, and that choice is not rivaroxaban,” she said.
The Icelandic Centre for Research and the Landspítali University Hospital Research Fund provided funds for this study. Dr. Ingason, Dr. Björnsson, Dr. Rockey, and Dr. Abraham reported no disclosures.
FROM ANNALS OF INTERNAL MEDICINE
An MD and a health care exec sued their employers for fraud: What happened?
James Taylor, MD, a former physician director of coding and medical director of revenue cycle at Kaiser’s Colorado Permanente Medical Group, just wanted Kaiser to do the right thing and stop submitting false claims to Medicare Advantage.
Dr. Taylor, who describes himself as tenacious to a fault, says he waited 7 years to file his lawsuit because he thought he could convince Kaiser to fix the coding problems on their end. He alternated between optimism and despair as Kaiser’s management supported some solutions only to shut them down later.
Finally, Dr. Taylor had had enough – the stress was getting to him, and his job was on the line.
As a last resort, he consulted a law firm that specializes in whistle-blower cases. Soon afterward, they filed a civil lawsuit in Colorado.
“My wife says that I have a justice gene – she can tell when it’s vibrating because I get amazed, not because people do wrong things, which they do all the time, but to that scale where it’s millions of dollars, and they’re being smug and acting like a bully. They thought they would never get caught and just kept going and even ramped it up in some situations,” says Dr. Taylor.
Several other whistle-blowers filed five lawsuits also alleging that Kaiser knew it was committing Medicare Advantage fraud amounting to tens of millions of dollars. The U.S. Department of Justice (DoJ) announced in July that it will join the six lawsuits and that it would file its complaint by late October.
Martin Mansukhani, a former regional CFO for Prime Health Care, was out of the country when the CEO signed a multimillion dollar contract with a cardiologist that went into effect immediately. At first, he tried to make the agreement work financially but then realized there were serious problems with the contract. He consulted a law firm, which confirmed that this was a kickback scheme in which the cardiologist was being overpaid in exchange for referring patients to Prime hospitals. The attorneys filed his whistle-blower lawsuit in 2017.
“My goal in filing the lawsuit was to get the company to stop these business practices,” says Mr. Mansukhani.
For being a whistle-blower, Mr. Mansukhani will receive nearly $10 million from the $37 settlement the DoJ negotiated. The False Claims Act entitles whistle-blowers to receive a higher reward (25% to 30%) when the DoJ doesn’t join a case than when it does (15% to 25%).
His lawsuit alleges that Prime Health Care, a hospital chain in California, its CEO, Prem Reddy, MD, and cardiologist Siva Arunasalam, MD, violated the federal Anti-Kickback Statute and the Stark Law, which generally make it illegal for anyone to offer or to provide something of value in exchange for a referral for a federal health care service. The suit also alleges that Prime had engaged in fraudulent billing practices.
The most challenging aspect was the decision to file the case. “It was a big-time commitment to pull together the evidence and to spend time interviewing law firms to determine who would best represent me, before I chose Phillips & Cohen,” says Mr. Mansukhani.
When management fails to listen
Dr. Taylor loved working at Kaiser Colorado and used to joke that he had job security as director of revenue cycle because doctors don’t like mixing business with medicine. He earned less money than when he was a family physician but “loved the lifestyle because it gave me time to spend with my wife and two young children.”
He was well thought of by the medical group – they elected him to serve on its board of directors for 4 years (2009-2013), during which time he served 2 years as chairman. They also sent him to Harvard’s executive leadership program.
As a certified risk adjustment coder and EPIC (the electronic medical records system that Kaiser used at that time) certified physician builder, Dr. Taylor had the expertise to recognize problems and fix them.
The audits that Kaiser and Dr. Taylor conducted showed high rates of errors for conditions related to cancer, stroke, and vascular disease.
“I hired a physician to review thousands of stroke codes and catch the false ones and created a filter in EPIC that weeded out incorrect codes before they were submitted,” Dr. Taylor says.
But these changes didn’t last because Kaiser managers would cancel or defund them, says Dr. Taylor. “That’s why I stayed for so many years. I would make one change and it would go very well and then they would shut it down. I would think, ‘This is great, they’re listening,’ but then it was gone. If all that had happened at once, I would have left immediately, but it was over time,” says Dr. Taylor.
He informed Kaiser Colorado’s upper management and its national organization about the problems, but he got nowhere.
Becoming a target
Dr. Taylor’s efforts to stop Kaiser from submitting false diagnosis codes didn’t sit well with the CFO.
Things came to a head in 2014 when Dr. Taylor discovered that a board meeting had been called to push him out of the company. “They said I failed a work improvement plan and that was why they needed to get me out.
“When they started saying that I was part of the problem after all the work I had done to keep their noses clean, I couldn’t tolerate it any longer. That’s when I filed the lawsuit,” says Dr. Taylor.
The stress from the “chaos and craziness” was also starting to affect his health, and he was worried that Kaiser would damage his reputation further.
He resigned in 2015. “I left 14 months before being fully vested in their retirement program.”
Employer retaliation?
Prime first sidelined and then fired Mr. Mansukhani (not for cause) in 2017 just before he filed his lawsuit. It offered him only 30 days of severance pay, which he didn’t accept. He didn’t think his firing was in retaliation for being a whistle-blower because his relationship with the chief operating officer had soured long before, in 2013, and the lawsuit was sealed.
At the time, he owned a nursing home in England that was doing well financially. He worried whether “Prime would try to retaliate against me in the U.K. I was a senior executive in a fairly high-profile position in the health care sector, and lots of informal networks exist,” says Mr. Mansukhani. But that never happened.
He found a new job right away. “At that stage of my life, I was 53 years old, and I wasn’t looking for another job. But College Healthcare in California offered me one as the CFO, which I accepted,” says Mr. Mansukhani.
Did it ruin his career?
Dr. Taylor also found a new job right away as chief medical officer of Colorado Access, where he trained practitioners on the Medicare Advantage model and documentation standards required by the Centers for Medicare & Medicaid Services (CMS). He is now an independent consultant with Principled Advantage.
Dr. Taylor’s lawsuit was filed under the False Claims Act, which requires that court documents be kept confidential (“sealed”) for at least 60 days while the DoJ investigates the case. Judges often extend that time frame.
In Dr. Taylor’s case, it took 7 years for the DoJ to unseal the documents. “The bad news is the wheels of justice turned really slowly. The good news was that I could seek employment and not have them worry about hiring a whistle-blower. As much as I didn’t like it, it was truly a blessing in disguise,” he says.
Dr. Taylor doesn’t know what the outcome of his case against Kaiser will be. When it was unsealed recently, he worried that local TV stations would show up at his doorstep and hound him or that Kaiser’s administrators would try to dig up dirt on him, which hasn’t happened.
He has no regrets about filing the lawsuit and feels vindicated because the managers/administrators who didn’t support him have been fired, including the CFO “who threw the biggest obstacles at me and defunded my work,” says Dr. Taylor.
The DoJ’s recent decision to join the consolidated whistle-blower case “was an indication that I was correct that Kaiser wasn’t doing what they should have been doing. You can’t have dishonest scales – if you’re purposely cheating the government to get promotions, more bonuses, that’s just wrong.”
Kaiser Permanente declined to comment on Dr. Taylor’s allegations and referred to its statement. “We are confident that Kaiser Permanente is compliant with Medicare Advantage program requirements, and we intend to strongly defend against the lawsuits alleging otherwise.”
“Our medical record documentation and risk adjustment diagnosis data submitted to the Centers for Medicare & Medicaid Services comply with applicable laws and Medicare Advantage program requirements. Our policies and practices represent well-reasoned and good-faith interpretations of sometimes vague and incomplete guidance from CMS,” according to the statement.
Did it make a difference?
When the government settles whistle-blower cases, the defendants usually admit no liability or wrongdoing, which some whistle-blowers find frustrating.
“I think the company was hurt by the lawsuit. It may make them think twice about doing this again,” says Mr. Mansukhani. However, he is cynical about whether the culture will change.
As part of its settlement, Prime agreed to amend its current corporate integrity agreement (CIA) from a previous 2018 settlement to include testing on physician compensation arrangements.
CIAs are standard monitoring agreements in the health care industry, and Prime asserts that it remains in full compliance, according to its statement.
Prime Health Care and Arunasalam did not respond to several interview requests. A statement from Prime in July says, “The settled matters related to an isolated, single physician practice in Southern California between 2015-2017 and billing of forty-five implantable device claims. The allegations did not involve patient care, but instead related to the valuation of a physician practice and the appropriate documentation for a limited number of implant claims totaling approximately $200,000. As soon as these matters were identified, Prime conducted an exhaustive internal review, fully cooperated with the DOJ, and negotiated a mutually acceptable resolution.”
A version of this article first appeared on Medscape.com.
James Taylor, MD, a former physician director of coding and medical director of revenue cycle at Kaiser’s Colorado Permanente Medical Group, just wanted Kaiser to do the right thing and stop submitting false claims to Medicare Advantage.
Dr. Taylor, who describes himself as tenacious to a fault, says he waited 7 years to file his lawsuit because he thought he could convince Kaiser to fix the coding problems on their end. He alternated between optimism and despair as Kaiser’s management supported some solutions only to shut them down later.
Finally, Dr. Taylor had had enough – the stress was getting to him, and his job was on the line.
As a last resort, he consulted a law firm that specializes in whistle-blower cases. Soon afterward, they filed a civil lawsuit in Colorado.
“My wife says that I have a justice gene – she can tell when it’s vibrating because I get amazed, not because people do wrong things, which they do all the time, but to that scale where it’s millions of dollars, and they’re being smug and acting like a bully. They thought they would never get caught and just kept going and even ramped it up in some situations,” says Dr. Taylor.
Several other whistle-blowers filed five lawsuits also alleging that Kaiser knew it was committing Medicare Advantage fraud amounting to tens of millions of dollars. The U.S. Department of Justice (DoJ) announced in July that it will join the six lawsuits and that it would file its complaint by late October.
Martin Mansukhani, a former regional CFO for Prime Health Care, was out of the country when the CEO signed a multimillion dollar contract with a cardiologist that went into effect immediately. At first, he tried to make the agreement work financially but then realized there were serious problems with the contract. He consulted a law firm, which confirmed that this was a kickback scheme in which the cardiologist was being overpaid in exchange for referring patients to Prime hospitals. The attorneys filed his whistle-blower lawsuit in 2017.
“My goal in filing the lawsuit was to get the company to stop these business practices,” says Mr. Mansukhani.
For being a whistle-blower, Mr. Mansukhani will receive nearly $10 million from the $37 settlement the DoJ negotiated. The False Claims Act entitles whistle-blowers to receive a higher reward (25% to 30%) when the DoJ doesn’t join a case than when it does (15% to 25%).
His lawsuit alleges that Prime Health Care, a hospital chain in California, its CEO, Prem Reddy, MD, and cardiologist Siva Arunasalam, MD, violated the federal Anti-Kickback Statute and the Stark Law, which generally make it illegal for anyone to offer or to provide something of value in exchange for a referral for a federal health care service. The suit also alleges that Prime had engaged in fraudulent billing practices.
The most challenging aspect was the decision to file the case. “It was a big-time commitment to pull together the evidence and to spend time interviewing law firms to determine who would best represent me, before I chose Phillips & Cohen,” says Mr. Mansukhani.
When management fails to listen
Dr. Taylor loved working at Kaiser Colorado and used to joke that he had job security as director of revenue cycle because doctors don’t like mixing business with medicine. He earned less money than when he was a family physician but “loved the lifestyle because it gave me time to spend with my wife and two young children.”
He was well thought of by the medical group – they elected him to serve on its board of directors for 4 years (2009-2013), during which time he served 2 years as chairman. They also sent him to Harvard’s executive leadership program.
As a certified risk adjustment coder and EPIC (the electronic medical records system that Kaiser used at that time) certified physician builder, Dr. Taylor had the expertise to recognize problems and fix them.
The audits that Kaiser and Dr. Taylor conducted showed high rates of errors for conditions related to cancer, stroke, and vascular disease.
“I hired a physician to review thousands of stroke codes and catch the false ones and created a filter in EPIC that weeded out incorrect codes before they were submitted,” Dr. Taylor says.
But these changes didn’t last because Kaiser managers would cancel or defund them, says Dr. Taylor. “That’s why I stayed for so many years. I would make one change and it would go very well and then they would shut it down. I would think, ‘This is great, they’re listening,’ but then it was gone. If all that had happened at once, I would have left immediately, but it was over time,” says Dr. Taylor.
He informed Kaiser Colorado’s upper management and its national organization about the problems, but he got nowhere.
Becoming a target
Dr. Taylor’s efforts to stop Kaiser from submitting false diagnosis codes didn’t sit well with the CFO.
Things came to a head in 2014 when Dr. Taylor discovered that a board meeting had been called to push him out of the company. “They said I failed a work improvement plan and that was why they needed to get me out.
“When they started saying that I was part of the problem after all the work I had done to keep their noses clean, I couldn’t tolerate it any longer. That’s when I filed the lawsuit,” says Dr. Taylor.
The stress from the “chaos and craziness” was also starting to affect his health, and he was worried that Kaiser would damage his reputation further.
He resigned in 2015. “I left 14 months before being fully vested in their retirement program.”
Employer retaliation?
Prime first sidelined and then fired Mr. Mansukhani (not for cause) in 2017 just before he filed his lawsuit. It offered him only 30 days of severance pay, which he didn’t accept. He didn’t think his firing was in retaliation for being a whistle-blower because his relationship with the chief operating officer had soured long before, in 2013, and the lawsuit was sealed.
At the time, he owned a nursing home in England that was doing well financially. He worried whether “Prime would try to retaliate against me in the U.K. I was a senior executive in a fairly high-profile position in the health care sector, and lots of informal networks exist,” says Mr. Mansukhani. But that never happened.
He found a new job right away. “At that stage of my life, I was 53 years old, and I wasn’t looking for another job. But College Healthcare in California offered me one as the CFO, which I accepted,” says Mr. Mansukhani.
Did it ruin his career?
Dr. Taylor also found a new job right away as chief medical officer of Colorado Access, where he trained practitioners on the Medicare Advantage model and documentation standards required by the Centers for Medicare & Medicaid Services (CMS). He is now an independent consultant with Principled Advantage.
Dr. Taylor’s lawsuit was filed under the False Claims Act, which requires that court documents be kept confidential (“sealed”) for at least 60 days while the DoJ investigates the case. Judges often extend that time frame.
In Dr. Taylor’s case, it took 7 years for the DoJ to unseal the documents. “The bad news is the wheels of justice turned really slowly. The good news was that I could seek employment and not have them worry about hiring a whistle-blower. As much as I didn’t like it, it was truly a blessing in disguise,” he says.
Dr. Taylor doesn’t know what the outcome of his case against Kaiser will be. When it was unsealed recently, he worried that local TV stations would show up at his doorstep and hound him or that Kaiser’s administrators would try to dig up dirt on him, which hasn’t happened.
He has no regrets about filing the lawsuit and feels vindicated because the managers/administrators who didn’t support him have been fired, including the CFO “who threw the biggest obstacles at me and defunded my work,” says Dr. Taylor.
The DoJ’s recent decision to join the consolidated whistle-blower case “was an indication that I was correct that Kaiser wasn’t doing what they should have been doing. You can’t have dishonest scales – if you’re purposely cheating the government to get promotions, more bonuses, that’s just wrong.”
Kaiser Permanente declined to comment on Dr. Taylor’s allegations and referred to its statement. “We are confident that Kaiser Permanente is compliant with Medicare Advantage program requirements, and we intend to strongly defend against the lawsuits alleging otherwise.”
“Our medical record documentation and risk adjustment diagnosis data submitted to the Centers for Medicare & Medicaid Services comply with applicable laws and Medicare Advantage program requirements. Our policies and practices represent well-reasoned and good-faith interpretations of sometimes vague and incomplete guidance from CMS,” according to the statement.
Did it make a difference?
When the government settles whistle-blower cases, the defendants usually admit no liability or wrongdoing, which some whistle-blowers find frustrating.
“I think the company was hurt by the lawsuit. It may make them think twice about doing this again,” says Mr. Mansukhani. However, he is cynical about whether the culture will change.
As part of its settlement, Prime agreed to amend its current corporate integrity agreement (CIA) from a previous 2018 settlement to include testing on physician compensation arrangements.
CIAs are standard monitoring agreements in the health care industry, and Prime asserts that it remains in full compliance, according to its statement.
Prime Health Care and Arunasalam did not respond to several interview requests. A statement from Prime in July says, “The settled matters related to an isolated, single physician practice in Southern California between 2015-2017 and billing of forty-five implantable device claims. The allegations did not involve patient care, but instead related to the valuation of a physician practice and the appropriate documentation for a limited number of implant claims totaling approximately $200,000. As soon as these matters were identified, Prime conducted an exhaustive internal review, fully cooperated with the DOJ, and negotiated a mutually acceptable resolution.”
A version of this article first appeared on Medscape.com.
James Taylor, MD, a former physician director of coding and medical director of revenue cycle at Kaiser’s Colorado Permanente Medical Group, just wanted Kaiser to do the right thing and stop submitting false claims to Medicare Advantage.
Dr. Taylor, who describes himself as tenacious to a fault, says he waited 7 years to file his lawsuit because he thought he could convince Kaiser to fix the coding problems on their end. He alternated between optimism and despair as Kaiser’s management supported some solutions only to shut them down later.
Finally, Dr. Taylor had had enough – the stress was getting to him, and his job was on the line.
As a last resort, he consulted a law firm that specializes in whistle-blower cases. Soon afterward, they filed a civil lawsuit in Colorado.
“My wife says that I have a justice gene – she can tell when it’s vibrating because I get amazed, not because people do wrong things, which they do all the time, but to that scale where it’s millions of dollars, and they’re being smug and acting like a bully. They thought they would never get caught and just kept going and even ramped it up in some situations,” says Dr. Taylor.
Several other whistle-blowers filed five lawsuits also alleging that Kaiser knew it was committing Medicare Advantage fraud amounting to tens of millions of dollars. The U.S. Department of Justice (DoJ) announced in July that it will join the six lawsuits and that it would file its complaint by late October.
Martin Mansukhani, a former regional CFO for Prime Health Care, was out of the country when the CEO signed a multimillion dollar contract with a cardiologist that went into effect immediately. At first, he tried to make the agreement work financially but then realized there were serious problems with the contract. He consulted a law firm, which confirmed that this was a kickback scheme in which the cardiologist was being overpaid in exchange for referring patients to Prime hospitals. The attorneys filed his whistle-blower lawsuit in 2017.
“My goal in filing the lawsuit was to get the company to stop these business practices,” says Mr. Mansukhani.
For being a whistle-blower, Mr. Mansukhani will receive nearly $10 million from the $37 settlement the DoJ negotiated. The False Claims Act entitles whistle-blowers to receive a higher reward (25% to 30%) when the DoJ doesn’t join a case than when it does (15% to 25%).
His lawsuit alleges that Prime Health Care, a hospital chain in California, its CEO, Prem Reddy, MD, and cardiologist Siva Arunasalam, MD, violated the federal Anti-Kickback Statute and the Stark Law, which generally make it illegal for anyone to offer or to provide something of value in exchange for a referral for a federal health care service. The suit also alleges that Prime had engaged in fraudulent billing practices.
The most challenging aspect was the decision to file the case. “It was a big-time commitment to pull together the evidence and to spend time interviewing law firms to determine who would best represent me, before I chose Phillips & Cohen,” says Mr. Mansukhani.
When management fails to listen
Dr. Taylor loved working at Kaiser Colorado and used to joke that he had job security as director of revenue cycle because doctors don’t like mixing business with medicine. He earned less money than when he was a family physician but “loved the lifestyle because it gave me time to spend with my wife and two young children.”
He was well thought of by the medical group – they elected him to serve on its board of directors for 4 years (2009-2013), during which time he served 2 years as chairman. They also sent him to Harvard’s executive leadership program.
As a certified risk adjustment coder and EPIC (the electronic medical records system that Kaiser used at that time) certified physician builder, Dr. Taylor had the expertise to recognize problems and fix them.
The audits that Kaiser and Dr. Taylor conducted showed high rates of errors for conditions related to cancer, stroke, and vascular disease.
“I hired a physician to review thousands of stroke codes and catch the false ones and created a filter in EPIC that weeded out incorrect codes before they were submitted,” Dr. Taylor says.
But these changes didn’t last because Kaiser managers would cancel or defund them, says Dr. Taylor. “That’s why I stayed for so many years. I would make one change and it would go very well and then they would shut it down. I would think, ‘This is great, they’re listening,’ but then it was gone. If all that had happened at once, I would have left immediately, but it was over time,” says Dr. Taylor.
He informed Kaiser Colorado’s upper management and its national organization about the problems, but he got nowhere.
Becoming a target
Dr. Taylor’s efforts to stop Kaiser from submitting false diagnosis codes didn’t sit well with the CFO.
Things came to a head in 2014 when Dr. Taylor discovered that a board meeting had been called to push him out of the company. “They said I failed a work improvement plan and that was why they needed to get me out.
“When they started saying that I was part of the problem after all the work I had done to keep their noses clean, I couldn’t tolerate it any longer. That’s when I filed the lawsuit,” says Dr. Taylor.
The stress from the “chaos and craziness” was also starting to affect his health, and he was worried that Kaiser would damage his reputation further.
He resigned in 2015. “I left 14 months before being fully vested in their retirement program.”
Employer retaliation?
Prime first sidelined and then fired Mr. Mansukhani (not for cause) in 2017 just before he filed his lawsuit. It offered him only 30 days of severance pay, which he didn’t accept. He didn’t think his firing was in retaliation for being a whistle-blower because his relationship with the chief operating officer had soured long before, in 2013, and the lawsuit was sealed.
At the time, he owned a nursing home in England that was doing well financially. He worried whether “Prime would try to retaliate against me in the U.K. I was a senior executive in a fairly high-profile position in the health care sector, and lots of informal networks exist,” says Mr. Mansukhani. But that never happened.
He found a new job right away. “At that stage of my life, I was 53 years old, and I wasn’t looking for another job. But College Healthcare in California offered me one as the CFO, which I accepted,” says Mr. Mansukhani.
Did it ruin his career?
Dr. Taylor also found a new job right away as chief medical officer of Colorado Access, where he trained practitioners on the Medicare Advantage model and documentation standards required by the Centers for Medicare & Medicaid Services (CMS). He is now an independent consultant with Principled Advantage.
Dr. Taylor’s lawsuit was filed under the False Claims Act, which requires that court documents be kept confidential (“sealed”) for at least 60 days while the DoJ investigates the case. Judges often extend that time frame.
In Dr. Taylor’s case, it took 7 years for the DoJ to unseal the documents. “The bad news is the wheels of justice turned really slowly. The good news was that I could seek employment and not have them worry about hiring a whistle-blower. As much as I didn’t like it, it was truly a blessing in disguise,” he says.
Dr. Taylor doesn’t know what the outcome of his case against Kaiser will be. When it was unsealed recently, he worried that local TV stations would show up at his doorstep and hound him or that Kaiser’s administrators would try to dig up dirt on him, which hasn’t happened.
He has no regrets about filing the lawsuit and feels vindicated because the managers/administrators who didn’t support him have been fired, including the CFO “who threw the biggest obstacles at me and defunded my work,” says Dr. Taylor.
The DoJ’s recent decision to join the consolidated whistle-blower case “was an indication that I was correct that Kaiser wasn’t doing what they should have been doing. You can’t have dishonest scales – if you’re purposely cheating the government to get promotions, more bonuses, that’s just wrong.”
Kaiser Permanente declined to comment on Dr. Taylor’s allegations and referred to its statement. “We are confident that Kaiser Permanente is compliant with Medicare Advantage program requirements, and we intend to strongly defend against the lawsuits alleging otherwise.”
“Our medical record documentation and risk adjustment diagnosis data submitted to the Centers for Medicare & Medicaid Services comply with applicable laws and Medicare Advantage program requirements. Our policies and practices represent well-reasoned and good-faith interpretations of sometimes vague and incomplete guidance from CMS,” according to the statement.
Did it make a difference?
When the government settles whistle-blower cases, the defendants usually admit no liability or wrongdoing, which some whistle-blowers find frustrating.
“I think the company was hurt by the lawsuit. It may make them think twice about doing this again,” says Mr. Mansukhani. However, he is cynical about whether the culture will change.
As part of its settlement, Prime agreed to amend its current corporate integrity agreement (CIA) from a previous 2018 settlement to include testing on physician compensation arrangements.
CIAs are standard monitoring agreements in the health care industry, and Prime asserts that it remains in full compliance, according to its statement.
Prime Health Care and Arunasalam did not respond to several interview requests. A statement from Prime in July says, “The settled matters related to an isolated, single physician practice in Southern California between 2015-2017 and billing of forty-five implantable device claims. The allegations did not involve patient care, but instead related to the valuation of a physician practice and the appropriate documentation for a limited number of implant claims totaling approximately $200,000. As soon as these matters were identified, Prime conducted an exhaustive internal review, fully cooperated with the DOJ, and negotiated a mutually acceptable resolution.”
A version of this article first appeared on Medscape.com.
Major insurers running billions of dollars behind on payments to hospitals and doctors
Anthem Blue Cross, the country’s second-biggest health insurance company, is behind on billions of dollars in payments owed to hospitals and doctors because of onerous new reimbursement rules, computer problems and mishandled claims, say hospital officials in multiple states.
Anthem, like other big insurers, is using the COVID-19 crisis as cover to institute “egregious” policies that harm patients and pinch hospital finances, said Molly Smith, group vice president at the American Hospital Association. “There’s this sense of ‘Everyone’s distracted. We can get this through.’ ”
Hospitals are also dealing with a spike in retroactive claims denials by UnitedHealthcare, the biggest health insurer, for ED care, the AHA said.
Hospitals say it is hurting their finances as many cope with COVID surges – even after the industry has received tens of billions of dollars in emergency assistance from the federal government.
“We recognize there have been some challenges” to prompt payments caused by claims-processing changes and “a new set of dynamics” amid the pandemic, Anthem spokesperson Colin Manning said in an email. “We apologize for any delays or inconvenience this may have caused.”
Virginia law requires insurers to pay claims within 40 days. In a Sept. 24 letter to state insurance regulators, VCU Health, a system that operates a large teaching hospital in Richmond associated with Virginia Commonwealth University, said Anthem owes it $385 million. More than 40% of the claims are more than 90 days old, VCU said.
For all Virginia hospitals, Anthem’s late, unpaid claims amount to “hundreds of millions of dollars,” the Virginia Hospital and Healthcare Association said in a June 23 letter to state regulators.
Nationwide, the payment delays “are creating an untenable situation,” the American Hospital Association said in a Sept. 9 letter to Anthem CEO Gail Boudreaux. “Patients are facing greater hurdles to accessing care; clinicians are burning out on unnecessary administrative tasks; and the system is straining to finance the personnel and supplies” needed to fight Covid.
Complaints about Anthem extend “from sea to shining sea, from New Hampshire to California,” AHA CEO Rick Pollack told KHN.
Substantial payment delays can be seen on Anthem’s books. On June 30, 2019, before the pandemic, 43% of the insurer’s medical bills for that quarter were unpaid, according to regulatory filings. Two years later that figure had risen to 53% – a difference of $2.5 billion.
Anthem profits were $4.6 billion in 2020 and $3.5 billion in the first half of 2021.
Alexis Thurber, who lives near Seattle, was insured by Anthem when she got an $18,192 hospital bill in May for radiation therapy that doctors said was essential to treat her breast cancer.
The treatments were “experimental” and “not medically necessary,” Anthem said, according to Ms. Thurber. She spent much of the summer trying to get the insurer to pay up – placing two dozen phone calls, spending hours on hold, sending multiple emails and enduring unmeasurable stress and worry. It finally covered the claim months later.
“It’s so egregious. It’s a game they’re playing,” said Ms. Thurber, 51, whose cancer was diagnosed in November. “Trying to get true help was impossible.”
Privacy rules prevent Anthem from commenting on Ms. Thurber’s case, said Anthem spokesperson Colin Manning.
When insurers fail to promptly pay medical bills, patients are left in the lurch. They might first get a notice saying payment is pending or denied. A hospital might bill them for treatment they thought would be covered. Hospitals and doctors often sue patients whose insurance didn’t pay up.
Hospitals point to a variety of Anthem practices contributing to payment delays or denials, including new layers of document requirements, prior-authorization hurdles for routine procedures and requirements that doctors themselves – not support staffers – speak to insurance gatekeepers. “This requires providers to literally leave the patient[’s] bedside to get on the phone with Anthem,” AHA said in its letter.
Anthem often hinders coverage for outpatient surgery, specialty pharmacy and other services in health systems listed as in network, amounting to a “bait and switch” on Anthem members, AHA officials said.
“Demanding that patients be treated outside of the hospital setting, against the advice of the patient’s in-network treating physician, appears to be motivated by a desire to drive up Empire’s profits,” the Greater New York Hospital Association wrote in an April letter to Empire Blue Cross, which is owned by Anthem.
Anthem officials pushed back in a recent letter to the AHA, saying the insurer’s changing rules are intended partly to control excessive prices charged by hospitals for specialty drugs and nonemergency surgery, screening and diagnostic procedures.
Severe problems with Anthem’s new claims management system surfaced months ago and “persist without meaningful improvement,” AHA said in its letter.
Claims have gotten lost in Anthem’s computers, and in some cases VCU Health has had to print medical records and mail them to get paid, VCU said in its letter. The cash slowdown imposes “an unmanageable disruption that threatens to undermine our financial footing,” VCU said.
United denied $31,557 in claims for Emily Long’s care after she was struck in June by a motorcycle in New York City. She needed surgery to repair a fractured cheekbone. United said there was a lack of documentation for “medical necessity” – an “incredibly aggravating” response on top of the distress of the accident, Ms. Long said.
The Brooklyn hospital that treated Ms. Long was “paid appropriately under her plan and within the required time frame,” said United spokesperson Maria Gordon Shydlo. “The facility has the right to appeal the decision.”
United’s unpaid claims came to 54% as of June 30, about the same level as 2 years previously.
When Erin Conlisk initially had trouble gaining approval for a piece of medical equipment for her elderly father this summer, United employees told her the insurer’s entire prior-authorization database had gone down for weeks, said Ms. Conlisk, who lives in California.
“There was a brief issue with our prior-authorization process in mid-July, which was resolved quickly,” Gordon Shydlo said.
When asked by Wall Street analysts about the payment backups, Anthem executives said it partly reflects their decision to increase financial reserves amid the health crisis.
“Really a ton of uncertainty associated with this environment,” John Gallina, the company’s chief financial officer, said on a conference call in July. “We’ve tried to be extremely prudent and conservative in our approach.”
During the pandemic, hospitals have benefited from two extraordinary cash infusions. They and other medical providers have received more than $100 billion through the CARES Act of 2020 and the American Rescue Plan of 2021. Last year United, Anthem and other insurers accelerated billions in hospital reimbursements.
The federal payments enriched many of the biggest, wealthiest systems while poorer hospitals serving low-income patients and rural areas struggled.
Those are the systems most hurt now by insurer payment delays, hospital officials said. Federal relief funds “have been a lifeline, but they don’t make people whole in terms of the losses from increased expenses and lost revenue as a result of the COVID experience,” Mr. Pollack said.
Several health systems declined to comment about claims payment delays or didn’t respond to a reporter’s queries. Among individual hospitals “there is a deep fear of talking on the record about your largest business partner,” AHA’s Ms. Smith said.
Alexis Thurber worried she might have to pay her $18,192 radiation bill herself, and she’s not confident her Anthem policy will do a better job next time of covering the cost of her care.
“It makes me not want to go to the doctor anymore,” she said. “I’m scared to get another mammogram because you can’t rely on it.”
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.
Anthem Blue Cross, the country’s second-biggest health insurance company, is behind on billions of dollars in payments owed to hospitals and doctors because of onerous new reimbursement rules, computer problems and mishandled claims, say hospital officials in multiple states.
Anthem, like other big insurers, is using the COVID-19 crisis as cover to institute “egregious” policies that harm patients and pinch hospital finances, said Molly Smith, group vice president at the American Hospital Association. “There’s this sense of ‘Everyone’s distracted. We can get this through.’ ”
Hospitals are also dealing with a spike in retroactive claims denials by UnitedHealthcare, the biggest health insurer, for ED care, the AHA said.
Hospitals say it is hurting their finances as many cope with COVID surges – even after the industry has received tens of billions of dollars in emergency assistance from the federal government.
“We recognize there have been some challenges” to prompt payments caused by claims-processing changes and “a new set of dynamics” amid the pandemic, Anthem spokesperson Colin Manning said in an email. “We apologize for any delays or inconvenience this may have caused.”
Virginia law requires insurers to pay claims within 40 days. In a Sept. 24 letter to state insurance regulators, VCU Health, a system that operates a large teaching hospital in Richmond associated with Virginia Commonwealth University, said Anthem owes it $385 million. More than 40% of the claims are more than 90 days old, VCU said.
For all Virginia hospitals, Anthem’s late, unpaid claims amount to “hundreds of millions of dollars,” the Virginia Hospital and Healthcare Association said in a June 23 letter to state regulators.
Nationwide, the payment delays “are creating an untenable situation,” the American Hospital Association said in a Sept. 9 letter to Anthem CEO Gail Boudreaux. “Patients are facing greater hurdles to accessing care; clinicians are burning out on unnecessary administrative tasks; and the system is straining to finance the personnel and supplies” needed to fight Covid.
Complaints about Anthem extend “from sea to shining sea, from New Hampshire to California,” AHA CEO Rick Pollack told KHN.
Substantial payment delays can be seen on Anthem’s books. On June 30, 2019, before the pandemic, 43% of the insurer’s medical bills for that quarter were unpaid, according to regulatory filings. Two years later that figure had risen to 53% – a difference of $2.5 billion.
Anthem profits were $4.6 billion in 2020 and $3.5 billion in the first half of 2021.
Alexis Thurber, who lives near Seattle, was insured by Anthem when she got an $18,192 hospital bill in May for radiation therapy that doctors said was essential to treat her breast cancer.
The treatments were “experimental” and “not medically necessary,” Anthem said, according to Ms. Thurber. She spent much of the summer trying to get the insurer to pay up – placing two dozen phone calls, spending hours on hold, sending multiple emails and enduring unmeasurable stress and worry. It finally covered the claim months later.
“It’s so egregious. It’s a game they’re playing,” said Ms. Thurber, 51, whose cancer was diagnosed in November. “Trying to get true help was impossible.”
Privacy rules prevent Anthem from commenting on Ms. Thurber’s case, said Anthem spokesperson Colin Manning.
When insurers fail to promptly pay medical bills, patients are left in the lurch. They might first get a notice saying payment is pending or denied. A hospital might bill them for treatment they thought would be covered. Hospitals and doctors often sue patients whose insurance didn’t pay up.
Hospitals point to a variety of Anthem practices contributing to payment delays or denials, including new layers of document requirements, prior-authorization hurdles for routine procedures and requirements that doctors themselves – not support staffers – speak to insurance gatekeepers. “This requires providers to literally leave the patient[’s] bedside to get on the phone with Anthem,” AHA said in its letter.
Anthem often hinders coverage for outpatient surgery, specialty pharmacy and other services in health systems listed as in network, amounting to a “bait and switch” on Anthem members, AHA officials said.
“Demanding that patients be treated outside of the hospital setting, against the advice of the patient’s in-network treating physician, appears to be motivated by a desire to drive up Empire’s profits,” the Greater New York Hospital Association wrote in an April letter to Empire Blue Cross, which is owned by Anthem.
Anthem officials pushed back in a recent letter to the AHA, saying the insurer’s changing rules are intended partly to control excessive prices charged by hospitals for specialty drugs and nonemergency surgery, screening and diagnostic procedures.
Severe problems with Anthem’s new claims management system surfaced months ago and “persist without meaningful improvement,” AHA said in its letter.
Claims have gotten lost in Anthem’s computers, and in some cases VCU Health has had to print medical records and mail them to get paid, VCU said in its letter. The cash slowdown imposes “an unmanageable disruption that threatens to undermine our financial footing,” VCU said.
United denied $31,557 in claims for Emily Long’s care after she was struck in June by a motorcycle in New York City. She needed surgery to repair a fractured cheekbone. United said there was a lack of documentation for “medical necessity” – an “incredibly aggravating” response on top of the distress of the accident, Ms. Long said.
The Brooklyn hospital that treated Ms. Long was “paid appropriately under her plan and within the required time frame,” said United spokesperson Maria Gordon Shydlo. “The facility has the right to appeal the decision.”
United’s unpaid claims came to 54% as of June 30, about the same level as 2 years previously.
When Erin Conlisk initially had trouble gaining approval for a piece of medical equipment for her elderly father this summer, United employees told her the insurer’s entire prior-authorization database had gone down for weeks, said Ms. Conlisk, who lives in California.
“There was a brief issue with our prior-authorization process in mid-July, which was resolved quickly,” Gordon Shydlo said.
When asked by Wall Street analysts about the payment backups, Anthem executives said it partly reflects their decision to increase financial reserves amid the health crisis.
“Really a ton of uncertainty associated with this environment,” John Gallina, the company’s chief financial officer, said on a conference call in July. “We’ve tried to be extremely prudent and conservative in our approach.”
During the pandemic, hospitals have benefited from two extraordinary cash infusions. They and other medical providers have received more than $100 billion through the CARES Act of 2020 and the American Rescue Plan of 2021. Last year United, Anthem and other insurers accelerated billions in hospital reimbursements.
The federal payments enriched many of the biggest, wealthiest systems while poorer hospitals serving low-income patients and rural areas struggled.
Those are the systems most hurt now by insurer payment delays, hospital officials said. Federal relief funds “have been a lifeline, but they don’t make people whole in terms of the losses from increased expenses and lost revenue as a result of the COVID experience,” Mr. Pollack said.
Several health systems declined to comment about claims payment delays or didn’t respond to a reporter’s queries. Among individual hospitals “there is a deep fear of talking on the record about your largest business partner,” AHA’s Ms. Smith said.
Alexis Thurber worried she might have to pay her $18,192 radiation bill herself, and she’s not confident her Anthem policy will do a better job next time of covering the cost of her care.
“It makes me not want to go to the doctor anymore,” she said. “I’m scared to get another mammogram because you can’t rely on it.”
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.
Anthem Blue Cross, the country’s second-biggest health insurance company, is behind on billions of dollars in payments owed to hospitals and doctors because of onerous new reimbursement rules, computer problems and mishandled claims, say hospital officials in multiple states.
Anthem, like other big insurers, is using the COVID-19 crisis as cover to institute “egregious” policies that harm patients and pinch hospital finances, said Molly Smith, group vice president at the American Hospital Association. “There’s this sense of ‘Everyone’s distracted. We can get this through.’ ”
Hospitals are also dealing with a spike in retroactive claims denials by UnitedHealthcare, the biggest health insurer, for ED care, the AHA said.
Hospitals say it is hurting their finances as many cope with COVID surges – even after the industry has received tens of billions of dollars in emergency assistance from the federal government.
“We recognize there have been some challenges” to prompt payments caused by claims-processing changes and “a new set of dynamics” amid the pandemic, Anthem spokesperson Colin Manning said in an email. “We apologize for any delays or inconvenience this may have caused.”
Virginia law requires insurers to pay claims within 40 days. In a Sept. 24 letter to state insurance regulators, VCU Health, a system that operates a large teaching hospital in Richmond associated with Virginia Commonwealth University, said Anthem owes it $385 million. More than 40% of the claims are more than 90 days old, VCU said.
For all Virginia hospitals, Anthem’s late, unpaid claims amount to “hundreds of millions of dollars,” the Virginia Hospital and Healthcare Association said in a June 23 letter to state regulators.
Nationwide, the payment delays “are creating an untenable situation,” the American Hospital Association said in a Sept. 9 letter to Anthem CEO Gail Boudreaux. “Patients are facing greater hurdles to accessing care; clinicians are burning out on unnecessary administrative tasks; and the system is straining to finance the personnel and supplies” needed to fight Covid.
Complaints about Anthem extend “from sea to shining sea, from New Hampshire to California,” AHA CEO Rick Pollack told KHN.
Substantial payment delays can be seen on Anthem’s books. On June 30, 2019, before the pandemic, 43% of the insurer’s medical bills for that quarter were unpaid, according to regulatory filings. Two years later that figure had risen to 53% – a difference of $2.5 billion.
Anthem profits were $4.6 billion in 2020 and $3.5 billion in the first half of 2021.
Alexis Thurber, who lives near Seattle, was insured by Anthem when she got an $18,192 hospital bill in May for radiation therapy that doctors said was essential to treat her breast cancer.
The treatments were “experimental” and “not medically necessary,” Anthem said, according to Ms. Thurber. She spent much of the summer trying to get the insurer to pay up – placing two dozen phone calls, spending hours on hold, sending multiple emails and enduring unmeasurable stress and worry. It finally covered the claim months later.
“It’s so egregious. It’s a game they’re playing,” said Ms. Thurber, 51, whose cancer was diagnosed in November. “Trying to get true help was impossible.”
Privacy rules prevent Anthem from commenting on Ms. Thurber’s case, said Anthem spokesperson Colin Manning.
When insurers fail to promptly pay medical bills, patients are left in the lurch. They might first get a notice saying payment is pending or denied. A hospital might bill them for treatment they thought would be covered. Hospitals and doctors often sue patients whose insurance didn’t pay up.
Hospitals point to a variety of Anthem practices contributing to payment delays or denials, including new layers of document requirements, prior-authorization hurdles for routine procedures and requirements that doctors themselves – not support staffers – speak to insurance gatekeepers. “This requires providers to literally leave the patient[’s] bedside to get on the phone with Anthem,” AHA said in its letter.
Anthem often hinders coverage for outpatient surgery, specialty pharmacy and other services in health systems listed as in network, amounting to a “bait and switch” on Anthem members, AHA officials said.
“Demanding that patients be treated outside of the hospital setting, against the advice of the patient’s in-network treating physician, appears to be motivated by a desire to drive up Empire’s profits,” the Greater New York Hospital Association wrote in an April letter to Empire Blue Cross, which is owned by Anthem.
Anthem officials pushed back in a recent letter to the AHA, saying the insurer’s changing rules are intended partly to control excessive prices charged by hospitals for specialty drugs and nonemergency surgery, screening and diagnostic procedures.
Severe problems with Anthem’s new claims management system surfaced months ago and “persist without meaningful improvement,” AHA said in its letter.
Claims have gotten lost in Anthem’s computers, and in some cases VCU Health has had to print medical records and mail them to get paid, VCU said in its letter. The cash slowdown imposes “an unmanageable disruption that threatens to undermine our financial footing,” VCU said.
United denied $31,557 in claims for Emily Long’s care after she was struck in June by a motorcycle in New York City. She needed surgery to repair a fractured cheekbone. United said there was a lack of documentation for “medical necessity” – an “incredibly aggravating” response on top of the distress of the accident, Ms. Long said.
The Brooklyn hospital that treated Ms. Long was “paid appropriately under her plan and within the required time frame,” said United spokesperson Maria Gordon Shydlo. “The facility has the right to appeal the decision.”
United’s unpaid claims came to 54% as of June 30, about the same level as 2 years previously.
When Erin Conlisk initially had trouble gaining approval for a piece of medical equipment for her elderly father this summer, United employees told her the insurer’s entire prior-authorization database had gone down for weeks, said Ms. Conlisk, who lives in California.
“There was a brief issue with our prior-authorization process in mid-July, which was resolved quickly,” Gordon Shydlo said.
When asked by Wall Street analysts about the payment backups, Anthem executives said it partly reflects their decision to increase financial reserves amid the health crisis.
“Really a ton of uncertainty associated with this environment,” John Gallina, the company’s chief financial officer, said on a conference call in July. “We’ve tried to be extremely prudent and conservative in our approach.”
During the pandemic, hospitals have benefited from two extraordinary cash infusions. They and other medical providers have received more than $100 billion through the CARES Act of 2020 and the American Rescue Plan of 2021. Last year United, Anthem and other insurers accelerated billions in hospital reimbursements.
The federal payments enriched many of the biggest, wealthiest systems while poorer hospitals serving low-income patients and rural areas struggled.
Those are the systems most hurt now by insurer payment delays, hospital officials said. Federal relief funds “have been a lifeline, but they don’t make people whole in terms of the losses from increased expenses and lost revenue as a result of the COVID experience,” Mr. Pollack said.
Several health systems declined to comment about claims payment delays or didn’t respond to a reporter’s queries. Among individual hospitals “there is a deep fear of talking on the record about your largest business partner,” AHA’s Ms. Smith said.
Alexis Thurber worried she might have to pay her $18,192 radiation bill herself, and she’s not confident her Anthem policy will do a better job next time of covering the cost of her care.
“It makes me not want to go to the doctor anymore,” she said. “I’m scared to get another mammogram because you can’t rely on it.”
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.
Web of antimicrobials doesn’t hold water
Music plus mushrooms equals therapy
Magic mushrooms have been used recreationally and medicinally for thousands of years, but researchers have found adding music could be a game changer in antidepressant treatment.
The ingredient that makes these mushrooms so magical is psilocybin. It works well for the clinical treatment of mental health conditions and some forms of depression because the “trip” can be contained to one work day, making it easy to administer under supervision. With the accompaniment of music, scientists have found that psilocybin evokes emotion.
This recent study, presented at the European College of Neuropsychopharmacology Congress in Lisbon, tested participants’ emotional response to music before and after the psilocybin. Ketanserin, an antihypertensive drug, was used to test against the effects of psilocybin. The scientist played Mozart and Elgar and found that participants on psilocybin had an emotional response increase of 60%. That response was even greater, compared with ketanserin, which actually lessened the emotional response to music.
“This shows that combination of psilocybin and music has a strong emotional effect, and we believe that this will be important for the therapeutic application of psychedelics if they are approved for clinical use,” said lead researcher Dea Siggaard Stenbæk of the University of Copenhagen.
Professor David J. Nutt of Imperial College in London, who was not involved in the study, said that it supports the use of music for treatment efficacy with psychedelics and suggested that the next step is to “optimise this approach probably through individualising and personalising music tracks in therapy.”
Cue the 1960s LSD music montage.
Chicken ‘white striping is not a disease’
Have you ever sliced open a new pack of chicken breasts to start dinner and noticed white fatty lines running through the chicken? Maybe you thought it was just some extra fat to trim off, but the Humane League calls it “white striping disease.”
Chicken is the No. 1 meat consumed by Americans, so it’s not surprising that chickens are factory farmed and raised to be ready for slaughter quickly, according to CBSNews.com, which reported that the Humane League claims white striping is found in 70% of the chicken in popular grocery stores. The league expressed concern for the chickens’ welfare as they are bred to grow bigger quickly, which is causing the white striping and increasing the fat content of the meat by as much as 224%.
The National Chicken Council told CBS that the league’s findings were unscientific. A spokesperson said, “White striping is not a disease. It is a quality factor in chicken breast meat caused by deposits of fat in the muscle during the bird’s growth and development.” He went on to say that severe white striping happens in 3%-6% of birds, which are mostly used in further processed products, not in chicken breast packages.
Somehow, that’s not making us feel any better.
The itsy bitsy spider lets us all down
Most people do not like spiders. That’s too bad, because spiders are generally nothing but helpful little creatures that prey upon annoying flies and other pests. Then there’s the silk they produce. The ancient Romans used it to treat conditions such as warts and skin lesions. Spiders wrap their eggs in silk to protect them from harmful bacteria.
Of course, we can hardly trust the medical opinions of people from 2,000 years ago, but modern-day studies have not definitively proved whether or not spider silk has any antimicrobial properties.
To settle the matter once and for all, researchers from Denmark built a silk-harvesting machine using the most famous of Danish inventions: Legos. The contraption, sort of a paddle wheel, pulled the silk from several different species of spider pinned down by the researchers. The silk was then tested against three different bacteria species, including good old Escherichia coli.
Unfortunately for our spider friends, their silk has no antimicrobial activity. The researchers suspected that any such activity seen in previous studies was actually caused by improper control for the solvents used to extract the silk; those solvents can have antimicrobial properties on their own. As for protecting their eggs, rather than killing bacteria, the silk likely provides a physical barrier alone.
It is bad news for spiders on the benefit-to-humanity front, but look at the bright side: If their silk had antimicrobial activity, we’d have to start farming them to acquire more silk. And that’s no good. Spiders deserve to roam free, hunt as they please, and drop down on your head from the ceiling.
Anxiety and allergies: Cause, effect, confusion
We’re big fans of science, but as longtime, totally impartial (Science rules!) observers of science’s medical realm, we can see that the day-to-day process of practicing the scientific method occasionally gets a bit messy. And no, we’re not talking about COVID-19.
We’re talking allergies. We’re talking mental health. We’re talking allergic disease and mental health.
We’re talking about a pair of press releases we came across during our never-ending search for material to educate, entertain, and astound our fabulously wonderful and loyal readers. (We say that, of course, in the most impartial way possible.)
The first release was titled, “Allergies including asthma and hay fever not linked to mental health traits” and covered research from the University of Bristol (England). The investigators were trying to determine if “allergic diseases actually causes mental health traits including anxiety, depression, bipolar disorder, and schizophrenia, or vice versa,” according to the release.
What they found, however, was “little evidence of a causal relationship between the onset of allergic disease and mental health.” Again, this is the press release talking.
The second release seemed to suggest the exact opposite: “Study uncovers link between allergies and mental health conditions.” That got our attention. A little more reading revealed that “people with asthma, atopic dermatitis, and hay fever also had a higher likelihood of having depression, anxiety, bipolar disorder, or neuroticism.”
One of the investigators was quoted as saying, “Establishing whether allergic disease causes mental health problems, or vice versa, is important to ensure that resources and treatment strategies are targeted appropriately.”
Did you notice the “vice versa”? Did you notice that it appeared in quotes from both releases? We did, so we took a closer look at the source. The second release covered a group of investigators from the University of Bristol – the same group, and the same study, in fact, as the first one.
So there you have it. One study, two press releases, and one confused journalist. Thank you, science.
Music plus mushrooms equals therapy
Magic mushrooms have been used recreationally and medicinally for thousands of years, but researchers have found adding music could be a game changer in antidepressant treatment.
The ingredient that makes these mushrooms so magical is psilocybin. It works well for the clinical treatment of mental health conditions and some forms of depression because the “trip” can be contained to one work day, making it easy to administer under supervision. With the accompaniment of music, scientists have found that psilocybin evokes emotion.
This recent study, presented at the European College of Neuropsychopharmacology Congress in Lisbon, tested participants’ emotional response to music before and after the psilocybin. Ketanserin, an antihypertensive drug, was used to test against the effects of psilocybin. The scientist played Mozart and Elgar and found that participants on psilocybin had an emotional response increase of 60%. That response was even greater, compared with ketanserin, which actually lessened the emotional response to music.
“This shows that combination of psilocybin and music has a strong emotional effect, and we believe that this will be important for the therapeutic application of psychedelics if they are approved for clinical use,” said lead researcher Dea Siggaard Stenbæk of the University of Copenhagen.
Professor David J. Nutt of Imperial College in London, who was not involved in the study, said that it supports the use of music for treatment efficacy with psychedelics and suggested that the next step is to “optimise this approach probably through individualising and personalising music tracks in therapy.”
Cue the 1960s LSD music montage.
Chicken ‘white striping is not a disease’
Have you ever sliced open a new pack of chicken breasts to start dinner and noticed white fatty lines running through the chicken? Maybe you thought it was just some extra fat to trim off, but the Humane League calls it “white striping disease.”
Chicken is the No. 1 meat consumed by Americans, so it’s not surprising that chickens are factory farmed and raised to be ready for slaughter quickly, according to CBSNews.com, which reported that the Humane League claims white striping is found in 70% of the chicken in popular grocery stores. The league expressed concern for the chickens’ welfare as they are bred to grow bigger quickly, which is causing the white striping and increasing the fat content of the meat by as much as 224%.
The National Chicken Council told CBS that the league’s findings were unscientific. A spokesperson said, “White striping is not a disease. It is a quality factor in chicken breast meat caused by deposits of fat in the muscle during the bird’s growth and development.” He went on to say that severe white striping happens in 3%-6% of birds, which are mostly used in further processed products, not in chicken breast packages.
Somehow, that’s not making us feel any better.
The itsy bitsy spider lets us all down
Most people do not like spiders. That’s too bad, because spiders are generally nothing but helpful little creatures that prey upon annoying flies and other pests. Then there’s the silk they produce. The ancient Romans used it to treat conditions such as warts and skin lesions. Spiders wrap their eggs in silk to protect them from harmful bacteria.
Of course, we can hardly trust the medical opinions of people from 2,000 years ago, but modern-day studies have not definitively proved whether or not spider silk has any antimicrobial properties.
To settle the matter once and for all, researchers from Denmark built a silk-harvesting machine using the most famous of Danish inventions: Legos. The contraption, sort of a paddle wheel, pulled the silk from several different species of spider pinned down by the researchers. The silk was then tested against three different bacteria species, including good old Escherichia coli.
Unfortunately for our spider friends, their silk has no antimicrobial activity. The researchers suspected that any such activity seen in previous studies was actually caused by improper control for the solvents used to extract the silk; those solvents can have antimicrobial properties on their own. As for protecting their eggs, rather than killing bacteria, the silk likely provides a physical barrier alone.
It is bad news for spiders on the benefit-to-humanity front, but look at the bright side: If their silk had antimicrobial activity, we’d have to start farming them to acquire more silk. And that’s no good. Spiders deserve to roam free, hunt as they please, and drop down on your head from the ceiling.
Anxiety and allergies: Cause, effect, confusion
We’re big fans of science, but as longtime, totally impartial (Science rules!) observers of science’s medical realm, we can see that the day-to-day process of practicing the scientific method occasionally gets a bit messy. And no, we’re not talking about COVID-19.
We’re talking allergies. We’re talking mental health. We’re talking allergic disease and mental health.
We’re talking about a pair of press releases we came across during our never-ending search for material to educate, entertain, and astound our fabulously wonderful and loyal readers. (We say that, of course, in the most impartial way possible.)
The first release was titled, “Allergies including asthma and hay fever not linked to mental health traits” and covered research from the University of Bristol (England). The investigators were trying to determine if “allergic diseases actually causes mental health traits including anxiety, depression, bipolar disorder, and schizophrenia, or vice versa,” according to the release.
What they found, however, was “little evidence of a causal relationship between the onset of allergic disease and mental health.” Again, this is the press release talking.
The second release seemed to suggest the exact opposite: “Study uncovers link between allergies and mental health conditions.” That got our attention. A little more reading revealed that “people with asthma, atopic dermatitis, and hay fever also had a higher likelihood of having depression, anxiety, bipolar disorder, or neuroticism.”
One of the investigators was quoted as saying, “Establishing whether allergic disease causes mental health problems, or vice versa, is important to ensure that resources and treatment strategies are targeted appropriately.”
Did you notice the “vice versa”? Did you notice that it appeared in quotes from both releases? We did, so we took a closer look at the source. The second release covered a group of investigators from the University of Bristol – the same group, and the same study, in fact, as the first one.
So there you have it. One study, two press releases, and one confused journalist. Thank you, science.
Music plus mushrooms equals therapy
Magic mushrooms have been used recreationally and medicinally for thousands of years, but researchers have found adding music could be a game changer in antidepressant treatment.
The ingredient that makes these mushrooms so magical is psilocybin. It works well for the clinical treatment of mental health conditions and some forms of depression because the “trip” can be contained to one work day, making it easy to administer under supervision. With the accompaniment of music, scientists have found that psilocybin evokes emotion.
This recent study, presented at the European College of Neuropsychopharmacology Congress in Lisbon, tested participants’ emotional response to music before and after the psilocybin. Ketanserin, an antihypertensive drug, was used to test against the effects of psilocybin. The scientist played Mozart and Elgar and found that participants on psilocybin had an emotional response increase of 60%. That response was even greater, compared with ketanserin, which actually lessened the emotional response to music.
“This shows that combination of psilocybin and music has a strong emotional effect, and we believe that this will be important for the therapeutic application of psychedelics if they are approved for clinical use,” said lead researcher Dea Siggaard Stenbæk of the University of Copenhagen.
Professor David J. Nutt of Imperial College in London, who was not involved in the study, said that it supports the use of music for treatment efficacy with psychedelics and suggested that the next step is to “optimise this approach probably through individualising and personalising music tracks in therapy.”
Cue the 1960s LSD music montage.
Chicken ‘white striping is not a disease’
Have you ever sliced open a new pack of chicken breasts to start dinner and noticed white fatty lines running through the chicken? Maybe you thought it was just some extra fat to trim off, but the Humane League calls it “white striping disease.”
Chicken is the No. 1 meat consumed by Americans, so it’s not surprising that chickens are factory farmed and raised to be ready for slaughter quickly, according to CBSNews.com, which reported that the Humane League claims white striping is found in 70% of the chicken in popular grocery stores. The league expressed concern for the chickens’ welfare as they are bred to grow bigger quickly, which is causing the white striping and increasing the fat content of the meat by as much as 224%.
The National Chicken Council told CBS that the league’s findings were unscientific. A spokesperson said, “White striping is not a disease. It is a quality factor in chicken breast meat caused by deposits of fat in the muscle during the bird’s growth and development.” He went on to say that severe white striping happens in 3%-6% of birds, which are mostly used in further processed products, not in chicken breast packages.
Somehow, that’s not making us feel any better.
The itsy bitsy spider lets us all down
Most people do not like spiders. That’s too bad, because spiders are generally nothing but helpful little creatures that prey upon annoying flies and other pests. Then there’s the silk they produce. The ancient Romans used it to treat conditions such as warts and skin lesions. Spiders wrap their eggs in silk to protect them from harmful bacteria.
Of course, we can hardly trust the medical opinions of people from 2,000 years ago, but modern-day studies have not definitively proved whether or not spider silk has any antimicrobial properties.
To settle the matter once and for all, researchers from Denmark built a silk-harvesting machine using the most famous of Danish inventions: Legos. The contraption, sort of a paddle wheel, pulled the silk from several different species of spider pinned down by the researchers. The silk was then tested against three different bacteria species, including good old Escherichia coli.
Unfortunately for our spider friends, their silk has no antimicrobial activity. The researchers suspected that any such activity seen in previous studies was actually caused by improper control for the solvents used to extract the silk; those solvents can have antimicrobial properties on their own. As for protecting their eggs, rather than killing bacteria, the silk likely provides a physical barrier alone.
It is bad news for spiders on the benefit-to-humanity front, but look at the bright side: If their silk had antimicrobial activity, we’d have to start farming them to acquire more silk. And that’s no good. Spiders deserve to roam free, hunt as they please, and drop down on your head from the ceiling.
Anxiety and allergies: Cause, effect, confusion
We’re big fans of science, but as longtime, totally impartial (Science rules!) observers of science’s medical realm, we can see that the day-to-day process of practicing the scientific method occasionally gets a bit messy. And no, we’re not talking about COVID-19.
We’re talking allergies. We’re talking mental health. We’re talking allergic disease and mental health.
We’re talking about a pair of press releases we came across during our never-ending search for material to educate, entertain, and astound our fabulously wonderful and loyal readers. (We say that, of course, in the most impartial way possible.)
The first release was titled, “Allergies including asthma and hay fever not linked to mental health traits” and covered research from the University of Bristol (England). The investigators were trying to determine if “allergic diseases actually causes mental health traits including anxiety, depression, bipolar disorder, and schizophrenia, or vice versa,” according to the release.
What they found, however, was “little evidence of a causal relationship between the onset of allergic disease and mental health.” Again, this is the press release talking.
The second release seemed to suggest the exact opposite: “Study uncovers link between allergies and mental health conditions.” That got our attention. A little more reading revealed that “people with asthma, atopic dermatitis, and hay fever also had a higher likelihood of having depression, anxiety, bipolar disorder, or neuroticism.”
One of the investigators was quoted as saying, “Establishing whether allergic disease causes mental health problems, or vice versa, is important to ensure that resources and treatment strategies are targeted appropriately.”
Did you notice the “vice versa”? Did you notice that it appeared in quotes from both releases? We did, so we took a closer look at the source. The second release covered a group of investigators from the University of Bristol – the same group, and the same study, in fact, as the first one.
So there you have it. One study, two press releases, and one confused journalist. Thank you, science.
Racism a strong factor in Black women’s high rate of premature births, study finds
Dr. Paula Braveman, director of the Center on Social Disparities in Health at the University of California, San Francisco, says her latest research revealed an “astounding” level of evidence that racism is a decisive “upstream” cause of higher rates of preterm birth among Black women.
The tipping point for Dr. Paula Braveman came when a longtime patient of hers at a community clinic in San Francisco’s Mission District slipped past the front desk and knocked on her office door to say goodbye. He wouldn’t be coming to the clinic anymore, he told her, because he could no longer afford it.
It was a decisive moment for Dr. Braveman, who decided she wanted not only to heal ailing patients but also to advocate for policies that would help them be healthier when they arrived at her clinic. In the nearly four decades since, Dr. Braveman has dedicated herself to studying the “social determinants of health” – how the spaces where we live, work, play and learn, and the relationships we have in those places influence how healthy we are.
As director of the Center on Social Disparities in Health at the University of California, San Francisco, Dr. Braveman has studied the link between neighborhood wealth and children’s health, and how access to insurance influences prenatal care. A longtime advocate of translating research into policy, she has collaborated on major health initiatives with the health department in San Francisco, the federal Centers for Disease Control and Prevention, and the World Health Organization.
Dr. Braveman has a particular interest in maternal and infant health. Her latest research reviews what’s known about the persistent gap in preterm birth rates between Black and White women in the United States. Black women are about 1.6 times as likely as White women to give birth more than three weeks before the due date. That statistic bears alarming and costly health consequences, as infants born prematurely are at higher risk for breathing, heart, and brain abnormalities, among other complications.
Dr. Braveman coauthored the review with a group of experts convened by the March of Dimes that included geneticists, clinicians, epidemiologists, biomedical experts, and neurologists. They examined more than two dozen suspected causes of preterm births – including quality of prenatal care, environmental toxics, chronic stress, poverty and obesity – and determined that racism, directly or indirectly, best explained the racial disparities in preterm birth rates.
(Note: In the review, the authors make extensive use of the terms “upstream” and “downstream” to describe what determines people’s health. A downstream risk is the condition or factor most directly responsible for a health outcome, while an upstream factor is what causes or fuels the downstream risk – and often what needs to change to prevent someone from becoming sick. For example, a person living near drinking water polluted with toxic chemicals might get sick from drinking the water. The downstream fix would be telling individuals to use filters. The upstream solution would be to stop the dumping of toxic chemicals.)
KHN spoke with Dr. Braveman about the study and its findings. The excerpts have been edited for length and style.
Q: You have been studying the issue of preterm birth and racial disparities for so long. Were there any findings from this review that surprised you?
The process of systematically going through all of the risk factors that are written about in the literature and then seeing how the story of racism was an upstream determinant for virtually all of them. That was kind of astounding.
The other thing that was very impressive: When we looked at the idea that genetic factors could be the cause of the Black-White disparity in preterm birth. The genetics experts in the group, and there were three or four of them, concluded from the evidence that genetic factors might influence the disparity in preterm birth, but at most the effect would be very small, very small indeed. This could not account for the greater rate of preterm birth among Black women compared to White women.
Q: You were looking to identify not just what causes preterm birth but also to explain racial differences in rates of preterm birth. Are there examples of factors that can influence preterm birth that don’t explain racial disparities?
It does look like there are genetic components to preterm birth, but they don’t explain the Black-White disparity in preterm birth. Another example is having an early elective C-section. That’s one of the problems contributing to avoidable preterm birth, but it doesn’t look like that’s really contributing to the Black-White disparity in preterm birth.
Q: You and your colleagues listed exactly one upstream cause of preterm birth: racism. How would you characterize the certainty that racism is a decisive upstream cause of higher rates of preterm birth among Black women?
It makes me think of this saying: A randomized clinical trial wouldn’t be necessary to give certainty about the importance of having a parachute on if you jump from a plane. To me, at this point, it is close to that.
Going through that paper – and we worked on that paper over a three- or four-year period, so there was a lot of time to think about it – I don’t see how the evidence that we have could be explained otherwise.
Q: What did you learn about how a mother’s broader lifetime experience of racism might affect birth outcomes versus what she experienced within the medical establishment during pregnancy?
There were many ways that experiencing racial discrimination would affect a woman’s pregnancy, but one major way would be through pathways and biological mechanisms involved in stress and stress physiology. In neuroscience, what’s been clear is that a chronic stressor seems to be more damaging to health than an acute stressor.
So it doesn’t make much sense to be looking only during pregnancy. But that’s where most of that research has been done: stress during pregnancy and racial discrimination, and its role in birth outcomes. Very few studies have looked at experiences of racial discrimination across the life course.
My colleagues and I have published a paper where we asked African American women about their experiences of racism, and we didn’t even define what we meant. Women did not talk a lot about the experiences of racism during pregnancy from their medical providers; they talked about the lifetime experience and particularly experiences going back to childhood. And they talked about having to worry, and constant vigilance, so that even if they’re not experiencing an incident, their antennae have to be out to be prepared in case an incident does occur.
Putting all of it together with what we know about stress physiology, I would put my money on the lifetime experiences being so much more important than experiences during pregnancy. There isn’t enough known about preterm birth, but from what is known, inflammation is involved, immune dysfunction, and that’s what stress leads to. The neuroscientists have shown us that chronic stress produces inflammation and immune system dysfunction.
Q: What policies do you think are most important at this stage for reducing preterm birth for Black women?
I wish I could just say one policy or two policies, but I think it does get back to the need to dismantle racism in our society. In all of its manifestations. That’s unfortunate, not to be able to say, “Oh, here, I have this magic bullet, and if you just go with that, that will solve the problem.”
If you take the conclusions of this study seriously, you say, well, policies to just go after these downstream factors are not going to work. It’s up to the upstream investment in trying to achieve a more equitable and less racist society. Ultimately, I think that’s the take-home, and it’s a tall, tall order.
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.
Dr. Paula Braveman, director of the Center on Social Disparities in Health at the University of California, San Francisco, says her latest research revealed an “astounding” level of evidence that racism is a decisive “upstream” cause of higher rates of preterm birth among Black women.
The tipping point for Dr. Paula Braveman came when a longtime patient of hers at a community clinic in San Francisco’s Mission District slipped past the front desk and knocked on her office door to say goodbye. He wouldn’t be coming to the clinic anymore, he told her, because he could no longer afford it.
It was a decisive moment for Dr. Braveman, who decided she wanted not only to heal ailing patients but also to advocate for policies that would help them be healthier when they arrived at her clinic. In the nearly four decades since, Dr. Braveman has dedicated herself to studying the “social determinants of health” – how the spaces where we live, work, play and learn, and the relationships we have in those places influence how healthy we are.
As director of the Center on Social Disparities in Health at the University of California, San Francisco, Dr. Braveman has studied the link between neighborhood wealth and children’s health, and how access to insurance influences prenatal care. A longtime advocate of translating research into policy, she has collaborated on major health initiatives with the health department in San Francisco, the federal Centers for Disease Control and Prevention, and the World Health Organization.
Dr. Braveman has a particular interest in maternal and infant health. Her latest research reviews what’s known about the persistent gap in preterm birth rates between Black and White women in the United States. Black women are about 1.6 times as likely as White women to give birth more than three weeks before the due date. That statistic bears alarming and costly health consequences, as infants born prematurely are at higher risk for breathing, heart, and brain abnormalities, among other complications.
Dr. Braveman coauthored the review with a group of experts convened by the March of Dimes that included geneticists, clinicians, epidemiologists, biomedical experts, and neurologists. They examined more than two dozen suspected causes of preterm births – including quality of prenatal care, environmental toxics, chronic stress, poverty and obesity – and determined that racism, directly or indirectly, best explained the racial disparities in preterm birth rates.
(Note: In the review, the authors make extensive use of the terms “upstream” and “downstream” to describe what determines people’s health. A downstream risk is the condition or factor most directly responsible for a health outcome, while an upstream factor is what causes or fuels the downstream risk – and often what needs to change to prevent someone from becoming sick. For example, a person living near drinking water polluted with toxic chemicals might get sick from drinking the water. The downstream fix would be telling individuals to use filters. The upstream solution would be to stop the dumping of toxic chemicals.)
KHN spoke with Dr. Braveman about the study and its findings. The excerpts have been edited for length and style.
Q: You have been studying the issue of preterm birth and racial disparities for so long. Were there any findings from this review that surprised you?
The process of systematically going through all of the risk factors that are written about in the literature and then seeing how the story of racism was an upstream determinant for virtually all of them. That was kind of astounding.
The other thing that was very impressive: When we looked at the idea that genetic factors could be the cause of the Black-White disparity in preterm birth. The genetics experts in the group, and there were three or four of them, concluded from the evidence that genetic factors might influence the disparity in preterm birth, but at most the effect would be very small, very small indeed. This could not account for the greater rate of preterm birth among Black women compared to White women.
Q: You were looking to identify not just what causes preterm birth but also to explain racial differences in rates of preterm birth. Are there examples of factors that can influence preterm birth that don’t explain racial disparities?
It does look like there are genetic components to preterm birth, but they don’t explain the Black-White disparity in preterm birth. Another example is having an early elective C-section. That’s one of the problems contributing to avoidable preterm birth, but it doesn’t look like that’s really contributing to the Black-White disparity in preterm birth.
Q: You and your colleagues listed exactly one upstream cause of preterm birth: racism. How would you characterize the certainty that racism is a decisive upstream cause of higher rates of preterm birth among Black women?
It makes me think of this saying: A randomized clinical trial wouldn’t be necessary to give certainty about the importance of having a parachute on if you jump from a plane. To me, at this point, it is close to that.
Going through that paper – and we worked on that paper over a three- or four-year period, so there was a lot of time to think about it – I don’t see how the evidence that we have could be explained otherwise.
Q: What did you learn about how a mother’s broader lifetime experience of racism might affect birth outcomes versus what she experienced within the medical establishment during pregnancy?
There were many ways that experiencing racial discrimination would affect a woman’s pregnancy, but one major way would be through pathways and biological mechanisms involved in stress and stress physiology. In neuroscience, what’s been clear is that a chronic stressor seems to be more damaging to health than an acute stressor.
So it doesn’t make much sense to be looking only during pregnancy. But that’s where most of that research has been done: stress during pregnancy and racial discrimination, and its role in birth outcomes. Very few studies have looked at experiences of racial discrimination across the life course.
My colleagues and I have published a paper where we asked African American women about their experiences of racism, and we didn’t even define what we meant. Women did not talk a lot about the experiences of racism during pregnancy from their medical providers; they talked about the lifetime experience and particularly experiences going back to childhood. And they talked about having to worry, and constant vigilance, so that even if they’re not experiencing an incident, their antennae have to be out to be prepared in case an incident does occur.
Putting all of it together with what we know about stress physiology, I would put my money on the lifetime experiences being so much more important than experiences during pregnancy. There isn’t enough known about preterm birth, but from what is known, inflammation is involved, immune dysfunction, and that’s what stress leads to. The neuroscientists have shown us that chronic stress produces inflammation and immune system dysfunction.
Q: What policies do you think are most important at this stage for reducing preterm birth for Black women?
I wish I could just say one policy or two policies, but I think it does get back to the need to dismantle racism in our society. In all of its manifestations. That’s unfortunate, not to be able to say, “Oh, here, I have this magic bullet, and if you just go with that, that will solve the problem.”
If you take the conclusions of this study seriously, you say, well, policies to just go after these downstream factors are not going to work. It’s up to the upstream investment in trying to achieve a more equitable and less racist society. Ultimately, I think that’s the take-home, and it’s a tall, tall order.
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.
Dr. Paula Braveman, director of the Center on Social Disparities in Health at the University of California, San Francisco, says her latest research revealed an “astounding” level of evidence that racism is a decisive “upstream” cause of higher rates of preterm birth among Black women.
The tipping point for Dr. Paula Braveman came when a longtime patient of hers at a community clinic in San Francisco’s Mission District slipped past the front desk and knocked on her office door to say goodbye. He wouldn’t be coming to the clinic anymore, he told her, because he could no longer afford it.
It was a decisive moment for Dr. Braveman, who decided she wanted not only to heal ailing patients but also to advocate for policies that would help them be healthier when they arrived at her clinic. In the nearly four decades since, Dr. Braveman has dedicated herself to studying the “social determinants of health” – how the spaces where we live, work, play and learn, and the relationships we have in those places influence how healthy we are.
As director of the Center on Social Disparities in Health at the University of California, San Francisco, Dr. Braveman has studied the link between neighborhood wealth and children’s health, and how access to insurance influences prenatal care. A longtime advocate of translating research into policy, she has collaborated on major health initiatives with the health department in San Francisco, the federal Centers for Disease Control and Prevention, and the World Health Organization.
Dr. Braveman has a particular interest in maternal and infant health. Her latest research reviews what’s known about the persistent gap in preterm birth rates between Black and White women in the United States. Black women are about 1.6 times as likely as White women to give birth more than three weeks before the due date. That statistic bears alarming and costly health consequences, as infants born prematurely are at higher risk for breathing, heart, and brain abnormalities, among other complications.
Dr. Braveman coauthored the review with a group of experts convened by the March of Dimes that included geneticists, clinicians, epidemiologists, biomedical experts, and neurologists. They examined more than two dozen suspected causes of preterm births – including quality of prenatal care, environmental toxics, chronic stress, poverty and obesity – and determined that racism, directly or indirectly, best explained the racial disparities in preterm birth rates.
(Note: In the review, the authors make extensive use of the terms “upstream” and “downstream” to describe what determines people’s health. A downstream risk is the condition or factor most directly responsible for a health outcome, while an upstream factor is what causes or fuels the downstream risk – and often what needs to change to prevent someone from becoming sick. For example, a person living near drinking water polluted with toxic chemicals might get sick from drinking the water. The downstream fix would be telling individuals to use filters. The upstream solution would be to stop the dumping of toxic chemicals.)
KHN spoke with Dr. Braveman about the study and its findings. The excerpts have been edited for length and style.
Q: You have been studying the issue of preterm birth and racial disparities for so long. Were there any findings from this review that surprised you?
The process of systematically going through all of the risk factors that are written about in the literature and then seeing how the story of racism was an upstream determinant for virtually all of them. That was kind of astounding.
The other thing that was very impressive: When we looked at the idea that genetic factors could be the cause of the Black-White disparity in preterm birth. The genetics experts in the group, and there were three or four of them, concluded from the evidence that genetic factors might influence the disparity in preterm birth, but at most the effect would be very small, very small indeed. This could not account for the greater rate of preterm birth among Black women compared to White women.
Q: You were looking to identify not just what causes preterm birth but also to explain racial differences in rates of preterm birth. Are there examples of factors that can influence preterm birth that don’t explain racial disparities?
It does look like there are genetic components to preterm birth, but they don’t explain the Black-White disparity in preterm birth. Another example is having an early elective C-section. That’s one of the problems contributing to avoidable preterm birth, but it doesn’t look like that’s really contributing to the Black-White disparity in preterm birth.
Q: You and your colleagues listed exactly one upstream cause of preterm birth: racism. How would you characterize the certainty that racism is a decisive upstream cause of higher rates of preterm birth among Black women?
It makes me think of this saying: A randomized clinical trial wouldn’t be necessary to give certainty about the importance of having a parachute on if you jump from a plane. To me, at this point, it is close to that.
Going through that paper – and we worked on that paper over a three- or four-year period, so there was a lot of time to think about it – I don’t see how the evidence that we have could be explained otherwise.
Q: What did you learn about how a mother’s broader lifetime experience of racism might affect birth outcomes versus what she experienced within the medical establishment during pregnancy?
There were many ways that experiencing racial discrimination would affect a woman’s pregnancy, but one major way would be through pathways and biological mechanisms involved in stress and stress physiology. In neuroscience, what’s been clear is that a chronic stressor seems to be more damaging to health than an acute stressor.
So it doesn’t make much sense to be looking only during pregnancy. But that’s where most of that research has been done: stress during pregnancy and racial discrimination, and its role in birth outcomes. Very few studies have looked at experiences of racial discrimination across the life course.
My colleagues and I have published a paper where we asked African American women about their experiences of racism, and we didn’t even define what we meant. Women did not talk a lot about the experiences of racism during pregnancy from their medical providers; they talked about the lifetime experience and particularly experiences going back to childhood. And they talked about having to worry, and constant vigilance, so that even if they’re not experiencing an incident, their antennae have to be out to be prepared in case an incident does occur.
Putting all of it together with what we know about stress physiology, I would put my money on the lifetime experiences being so much more important than experiences during pregnancy. There isn’t enough known about preterm birth, but from what is known, inflammation is involved, immune dysfunction, and that’s what stress leads to. The neuroscientists have shown us that chronic stress produces inflammation and immune system dysfunction.
Q: What policies do you think are most important at this stage for reducing preterm birth for Black women?
I wish I could just say one policy or two policies, but I think it does get back to the need to dismantle racism in our society. In all of its manifestations. That’s unfortunate, not to be able to say, “Oh, here, I have this magic bullet, and if you just go with that, that will solve the problem.”
If you take the conclusions of this study seriously, you say, well, policies to just go after these downstream factors are not going to work. It’s up to the upstream investment in trying to achieve a more equitable and less racist society. Ultimately, I think that’s the take-home, and it’s a tall, tall order.
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.
Med student’s skills put to the test saving life of accident victim
Third-year medical student Liz Groesbeck was like other excited Las Vegas Raiders fans recently headed to the first full-capacity game in the new Allegiant Stadium since the team moved to “Sin City.” She was in an Uber on a first date just blocks from the game that would pit her Raiders against the Seattle Seahawks when she saw a man on the ground and people gathered around him.
Abandoning her keys, cellphone, and date in the Uber, Ms. Groesbeck popped out to see if she could help. The Uber had been stuck in traffic, so Ms. Groesbeck thought she’d still be able to jump back in the car if she wasn’t needed.
Then she heard screams. “That didn’t concern me. People scream whenever anything unexpected happens,” said the 28-year-old student from the Kirk Kerkorian School of Medicine at the University of Nevada, Las Vegas (UNLV). But the screams were only a small indication of what she would discover on closer inspection. The arm of the middle-aged man lying on the ground was detached. An abandoned gold SUV remained on the curb nearby. It would turn out to be a hit-and-run of pedestrians by a driver later charged by police with DUI.
“I was one of the first people there,” Ms. Groesbeck recounted for this news organization. “I knew this guy did not just fall. I told someone to call EMS and I got someone to take his wife somewhere else [away from the bloody scene]. She was obviously very distraught. …At a couple of points she was hysterical.”
Next, Ms. Groesbeck, who, ironically, had finished her emergency general surgery rotation the day before, focused on the patient. Kneeling beside him, she determined that the immediate priorities were to stop the bleeding and clear his airway. “He was barely breathing,” she recounted. Another student who Ms. Groesbeck believes was pursuing a medical degree — there wasn’t time for formal introductions — offered to help, along with bystanders headed to the game.
“The crowd was very energetic. It was a beautiful thing.” Ms. Groesbeck cited the spirit of saving lives that developed from the October 1, 2017, Las Vegas country music festival shooting. “People are very willing to try to help others in any way they can.”
MS. Groesbeck, leading the effort, asked for belts, “and bystanders immediately provided that,” and the other student followed Ms. Groesbeck’s directions to apply tourniquets with the help of those around her. With the blood loss being stemmed, Ms. Groesbeck’s next priority was making sure the patient could breathe.
Appealing for clothing to clear the man’s airway, “five shirts were handed in a circle to me.” She only needed one jersey to scoop the blood out of his mouth manually to free his airway.
She overruled well-meaning suggestions to lay the man on his side — which she was concerned could paralyze him — or use a straw to help him breathe. “I did not want to stick anything down his throat.” Meanwhile, there was so much traffic that night around Allegiant Stadium that when the ambulance couldn’t get any closer the firefighters and paramedics exited the vehicle and ran to the scene.
From training to practice
The decisions Ms. Groesbeck made until they could arrive called upon her years of training to be a doctor, and specifically an EMT certification course she had to pass before beginning medical school, she said.
She credits the life-saving methods she learned in that course to Douglas Fraser, MD, FACS, associate professor of surgery at UNLV and University Medical Center (UMC) trauma medical director. He happened to be the attending physician when the accident victim was admitted to the hospital that night in critical condition. The man’s wife also was injured, but not to the extent of her husband.
Dr. Fraser said he didn’t know at the time that his student had been involved in saving the man’s life until Ms. Groesbeck reached out to say thanks for teaching her what to do in an emergency. “I [first] was overly impressed that she did that. Students are so busy; they move after they graduate or finish their rotations. You don’t get to see them time and time again; your short time with them could have a lasting impact and that is my goal,” Dr. Fraser told this news organization.
“They rarely thank you or reflect back. It renewed my sense that I want to teach more, to see the positive impact it had on Elizabeth” and other students, he said.
In terms of the emergency situation she navigated, Dr. Fraser said he was very proud of his student, but was also concerned she could have gotten hurt herself in the middle of a busy intersection. “She was selfless and put herself in harm’s way to help someone.” He also noted it was the first time he knew of a student putting her skills to the test so soon after learning them. “It was a good outcome and she truly provided lifesaving care to this victim.”
He attributed her training to the Stop the Bleed program, which began after the Sandy Hook tragedy in 2012. UNLV requires new med students to complete the American College of Surgeons’ first aid program to learn how to stop the bleeding of a severely injured person by applying tourniquets and pressure. “You have to stop the bleeding right away…and look to see whether their airway is open and if it’s not, open their airway or you won’t have a patient very long. I know she did that. These are the two most important lifesaving skills that she did.”
Medical students are often called upon as doctors by their family and friends, Dr. Fraser continued. “Everyone looks to you. It can happen on an airplane; you can be anywhere. She heard a person was in need and jumped to action and was able to use the training her school provided and was able to put it to good use.”
Not her first call to action
Just the week before the incident, Ms. Groesbeck was on clinical rotations at UMC helping in the emergency and operating rooms. “She was always very engaged and mature beyond her years,” Dr. Fraser said. “She definitely had that ‘it’ factor. She was sincere with patients and their families and performed well in the operating room. …She was very comfortable around the patients; very comfortable in stressful situations.”
He added, “I look forward to her participating in trauma surgery rotations in the near future.”
In the meantime, Ms. Groesbeck was pleased to learn that the man she saved survived and thrilled to be part of that effort. As of press time, he had not contacted her. Nor has the other student who helped save his life.
“A lot of people stepped up and donated their time to help. He got lucky on a very unlucky day,” Ms. Groesbeck said.
She recalled a previous accident victim years ago who wasn’t as lucky. On the way to pick up her white coat for the ceremony before her first year of medical school, she came upon a car that had flipped upside down. “It sheared the roof away. I checked on the restrained passenger. He was partially scalped. The windows were broken and I climbed in next to him.” This time, she used her own shirt to hold pressure on the wound. “He, unfortunately did not make it.” There was nothing she could have done, she was told.
“That one got me mentally. Very graphic imaging was stuck in my head,” Ms. Groesbeck said. With a masters in neuroscience, she was accustomed to seeing the brain, “but not like this. I felt sad he passed in such a violent way.” So the more recent life-saving experience was redemptive, she said. “I’ve been through hell and back.”
And she’s still on track to become the doctor she envisioned as a child, mummifying her cats with gauze wraps and covering her little sister with adhesive bandages. “It felt good knowing what I could do,” Ms. Groesbeck said. “I’m glad this [man] made it. He got lucky and he could go home to his family. I was not positive when he left in the ambulance. It was a huge relief.”
Of her role in the episode and her future career ambitions, Ms. Groesbeck noted: “We are studying all the time. It’s not very rewarding. But this, not thinking but having sprung into action, doing the right thing and he could go home to his family a week later. It’s things like this that make the endless hours of studying worth it. I feel like I accomplished something.”
A version of this article first appeared on Medscape.com.
Third-year medical student Liz Groesbeck was like other excited Las Vegas Raiders fans recently headed to the first full-capacity game in the new Allegiant Stadium since the team moved to “Sin City.” She was in an Uber on a first date just blocks from the game that would pit her Raiders against the Seattle Seahawks when she saw a man on the ground and people gathered around him.
Abandoning her keys, cellphone, and date in the Uber, Ms. Groesbeck popped out to see if she could help. The Uber had been stuck in traffic, so Ms. Groesbeck thought she’d still be able to jump back in the car if she wasn’t needed.
Then she heard screams. “That didn’t concern me. People scream whenever anything unexpected happens,” said the 28-year-old student from the Kirk Kerkorian School of Medicine at the University of Nevada, Las Vegas (UNLV). But the screams were only a small indication of what she would discover on closer inspection. The arm of the middle-aged man lying on the ground was detached. An abandoned gold SUV remained on the curb nearby. It would turn out to be a hit-and-run of pedestrians by a driver later charged by police with DUI.
“I was one of the first people there,” Ms. Groesbeck recounted for this news organization. “I knew this guy did not just fall. I told someone to call EMS and I got someone to take his wife somewhere else [away from the bloody scene]. She was obviously very distraught. …At a couple of points she was hysterical.”
Next, Ms. Groesbeck, who, ironically, had finished her emergency general surgery rotation the day before, focused on the patient. Kneeling beside him, she determined that the immediate priorities were to stop the bleeding and clear his airway. “He was barely breathing,” she recounted. Another student who Ms. Groesbeck believes was pursuing a medical degree — there wasn’t time for formal introductions — offered to help, along with bystanders headed to the game.
“The crowd was very energetic. It was a beautiful thing.” Ms. Groesbeck cited the spirit of saving lives that developed from the October 1, 2017, Las Vegas country music festival shooting. “People are very willing to try to help others in any way they can.”
MS. Groesbeck, leading the effort, asked for belts, “and bystanders immediately provided that,” and the other student followed Ms. Groesbeck’s directions to apply tourniquets with the help of those around her. With the blood loss being stemmed, Ms. Groesbeck’s next priority was making sure the patient could breathe.
Appealing for clothing to clear the man’s airway, “five shirts were handed in a circle to me.” She only needed one jersey to scoop the blood out of his mouth manually to free his airway.
She overruled well-meaning suggestions to lay the man on his side — which she was concerned could paralyze him — or use a straw to help him breathe. “I did not want to stick anything down his throat.” Meanwhile, there was so much traffic that night around Allegiant Stadium that when the ambulance couldn’t get any closer the firefighters and paramedics exited the vehicle and ran to the scene.
From training to practice
The decisions Ms. Groesbeck made until they could arrive called upon her years of training to be a doctor, and specifically an EMT certification course she had to pass before beginning medical school, she said.
She credits the life-saving methods she learned in that course to Douglas Fraser, MD, FACS, associate professor of surgery at UNLV and University Medical Center (UMC) trauma medical director. He happened to be the attending physician when the accident victim was admitted to the hospital that night in critical condition. The man’s wife also was injured, but not to the extent of her husband.
Dr. Fraser said he didn’t know at the time that his student had been involved in saving the man’s life until Ms. Groesbeck reached out to say thanks for teaching her what to do in an emergency. “I [first] was overly impressed that she did that. Students are so busy; they move after they graduate or finish their rotations. You don’t get to see them time and time again; your short time with them could have a lasting impact and that is my goal,” Dr. Fraser told this news organization.
“They rarely thank you or reflect back. It renewed my sense that I want to teach more, to see the positive impact it had on Elizabeth” and other students, he said.
In terms of the emergency situation she navigated, Dr. Fraser said he was very proud of his student, but was also concerned she could have gotten hurt herself in the middle of a busy intersection. “She was selfless and put herself in harm’s way to help someone.” He also noted it was the first time he knew of a student putting her skills to the test so soon after learning them. “It was a good outcome and she truly provided lifesaving care to this victim.”
He attributed her training to the Stop the Bleed program, which began after the Sandy Hook tragedy in 2012. UNLV requires new med students to complete the American College of Surgeons’ first aid program to learn how to stop the bleeding of a severely injured person by applying tourniquets and pressure. “You have to stop the bleeding right away…and look to see whether their airway is open and if it’s not, open their airway or you won’t have a patient very long. I know she did that. These are the two most important lifesaving skills that she did.”
Medical students are often called upon as doctors by their family and friends, Dr. Fraser continued. “Everyone looks to you. It can happen on an airplane; you can be anywhere. She heard a person was in need and jumped to action and was able to use the training her school provided and was able to put it to good use.”
Not her first call to action
Just the week before the incident, Ms. Groesbeck was on clinical rotations at UMC helping in the emergency and operating rooms. “She was always very engaged and mature beyond her years,” Dr. Fraser said. “She definitely had that ‘it’ factor. She was sincere with patients and their families and performed well in the operating room. …She was very comfortable around the patients; very comfortable in stressful situations.”
He added, “I look forward to her participating in trauma surgery rotations in the near future.”
In the meantime, Ms. Groesbeck was pleased to learn that the man she saved survived and thrilled to be part of that effort. As of press time, he had not contacted her. Nor has the other student who helped save his life.
“A lot of people stepped up and donated their time to help. He got lucky on a very unlucky day,” Ms. Groesbeck said.
She recalled a previous accident victim years ago who wasn’t as lucky. On the way to pick up her white coat for the ceremony before her first year of medical school, she came upon a car that had flipped upside down. “It sheared the roof away. I checked on the restrained passenger. He was partially scalped. The windows were broken and I climbed in next to him.” This time, she used her own shirt to hold pressure on the wound. “He, unfortunately did not make it.” There was nothing she could have done, she was told.
“That one got me mentally. Very graphic imaging was stuck in my head,” Ms. Groesbeck said. With a masters in neuroscience, she was accustomed to seeing the brain, “but not like this. I felt sad he passed in such a violent way.” So the more recent life-saving experience was redemptive, she said. “I’ve been through hell and back.”
And she’s still on track to become the doctor she envisioned as a child, mummifying her cats with gauze wraps and covering her little sister with adhesive bandages. “It felt good knowing what I could do,” Ms. Groesbeck said. “I’m glad this [man] made it. He got lucky and he could go home to his family. I was not positive when he left in the ambulance. It was a huge relief.”
Of her role in the episode and her future career ambitions, Ms. Groesbeck noted: “We are studying all the time. It’s not very rewarding. But this, not thinking but having sprung into action, doing the right thing and he could go home to his family a week later. It’s things like this that make the endless hours of studying worth it. I feel like I accomplished something.”
A version of this article first appeared on Medscape.com.
Third-year medical student Liz Groesbeck was like other excited Las Vegas Raiders fans recently headed to the first full-capacity game in the new Allegiant Stadium since the team moved to “Sin City.” She was in an Uber on a first date just blocks from the game that would pit her Raiders against the Seattle Seahawks when she saw a man on the ground and people gathered around him.
Abandoning her keys, cellphone, and date in the Uber, Ms. Groesbeck popped out to see if she could help. The Uber had been stuck in traffic, so Ms. Groesbeck thought she’d still be able to jump back in the car if she wasn’t needed.
Then she heard screams. “That didn’t concern me. People scream whenever anything unexpected happens,” said the 28-year-old student from the Kirk Kerkorian School of Medicine at the University of Nevada, Las Vegas (UNLV). But the screams were only a small indication of what she would discover on closer inspection. The arm of the middle-aged man lying on the ground was detached. An abandoned gold SUV remained on the curb nearby. It would turn out to be a hit-and-run of pedestrians by a driver later charged by police with DUI.
“I was one of the first people there,” Ms. Groesbeck recounted for this news organization. “I knew this guy did not just fall. I told someone to call EMS and I got someone to take his wife somewhere else [away from the bloody scene]. She was obviously very distraught. …At a couple of points she was hysterical.”
Next, Ms. Groesbeck, who, ironically, had finished her emergency general surgery rotation the day before, focused on the patient. Kneeling beside him, she determined that the immediate priorities were to stop the bleeding and clear his airway. “He was barely breathing,” she recounted. Another student who Ms. Groesbeck believes was pursuing a medical degree — there wasn’t time for formal introductions — offered to help, along with bystanders headed to the game.
“The crowd was very energetic. It was a beautiful thing.” Ms. Groesbeck cited the spirit of saving lives that developed from the October 1, 2017, Las Vegas country music festival shooting. “People are very willing to try to help others in any way they can.”
MS. Groesbeck, leading the effort, asked for belts, “and bystanders immediately provided that,” and the other student followed Ms. Groesbeck’s directions to apply tourniquets with the help of those around her. With the blood loss being stemmed, Ms. Groesbeck’s next priority was making sure the patient could breathe.
Appealing for clothing to clear the man’s airway, “five shirts were handed in a circle to me.” She only needed one jersey to scoop the blood out of his mouth manually to free his airway.
She overruled well-meaning suggestions to lay the man on his side — which she was concerned could paralyze him — or use a straw to help him breathe. “I did not want to stick anything down his throat.” Meanwhile, there was so much traffic that night around Allegiant Stadium that when the ambulance couldn’t get any closer the firefighters and paramedics exited the vehicle and ran to the scene.
From training to practice
The decisions Ms. Groesbeck made until they could arrive called upon her years of training to be a doctor, and specifically an EMT certification course she had to pass before beginning medical school, she said.
She credits the life-saving methods she learned in that course to Douglas Fraser, MD, FACS, associate professor of surgery at UNLV and University Medical Center (UMC) trauma medical director. He happened to be the attending physician when the accident victim was admitted to the hospital that night in critical condition. The man’s wife also was injured, but not to the extent of her husband.
Dr. Fraser said he didn’t know at the time that his student had been involved in saving the man’s life until Ms. Groesbeck reached out to say thanks for teaching her what to do in an emergency. “I [first] was overly impressed that she did that. Students are so busy; they move after they graduate or finish their rotations. You don’t get to see them time and time again; your short time with them could have a lasting impact and that is my goal,” Dr. Fraser told this news organization.
“They rarely thank you or reflect back. It renewed my sense that I want to teach more, to see the positive impact it had on Elizabeth” and other students, he said.
In terms of the emergency situation she navigated, Dr. Fraser said he was very proud of his student, but was also concerned she could have gotten hurt herself in the middle of a busy intersection. “She was selfless and put herself in harm’s way to help someone.” He also noted it was the first time he knew of a student putting her skills to the test so soon after learning them. “It was a good outcome and she truly provided lifesaving care to this victim.”
He attributed her training to the Stop the Bleed program, which began after the Sandy Hook tragedy in 2012. UNLV requires new med students to complete the American College of Surgeons’ first aid program to learn how to stop the bleeding of a severely injured person by applying tourniquets and pressure. “You have to stop the bleeding right away…and look to see whether their airway is open and if it’s not, open their airway or you won’t have a patient very long. I know she did that. These are the two most important lifesaving skills that she did.”
Medical students are often called upon as doctors by their family and friends, Dr. Fraser continued. “Everyone looks to you. It can happen on an airplane; you can be anywhere. She heard a person was in need and jumped to action and was able to use the training her school provided and was able to put it to good use.”
Not her first call to action
Just the week before the incident, Ms. Groesbeck was on clinical rotations at UMC helping in the emergency and operating rooms. “She was always very engaged and mature beyond her years,” Dr. Fraser said. “She definitely had that ‘it’ factor. She was sincere with patients and their families and performed well in the operating room. …She was very comfortable around the patients; very comfortable in stressful situations.”
He added, “I look forward to her participating in trauma surgery rotations in the near future.”
In the meantime, Ms. Groesbeck was pleased to learn that the man she saved survived and thrilled to be part of that effort. As of press time, he had not contacted her. Nor has the other student who helped save his life.
“A lot of people stepped up and donated their time to help. He got lucky on a very unlucky day,” Ms. Groesbeck said.
She recalled a previous accident victim years ago who wasn’t as lucky. On the way to pick up her white coat for the ceremony before her first year of medical school, she came upon a car that had flipped upside down. “It sheared the roof away. I checked on the restrained passenger. He was partially scalped. The windows were broken and I climbed in next to him.” This time, she used her own shirt to hold pressure on the wound. “He, unfortunately did not make it.” There was nothing she could have done, she was told.
“That one got me mentally. Very graphic imaging was stuck in my head,” Ms. Groesbeck said. With a masters in neuroscience, she was accustomed to seeing the brain, “but not like this. I felt sad he passed in such a violent way.” So the more recent life-saving experience was redemptive, she said. “I’ve been through hell and back.”
And she’s still on track to become the doctor she envisioned as a child, mummifying her cats with gauze wraps and covering her little sister with adhesive bandages. “It felt good knowing what I could do,” Ms. Groesbeck said. “I’m glad this [man] made it. He got lucky and he could go home to his family. I was not positive when he left in the ambulance. It was a huge relief.”
Of her role in the episode and her future career ambitions, Ms. Groesbeck noted: “We are studying all the time. It’s not very rewarding. But this, not thinking but having sprung into action, doing the right thing and he could go home to his family a week later. It’s things like this that make the endless hours of studying worth it. I feel like I accomplished something.”
A version of this article first appeared on Medscape.com.
Vaccine holdouts embrace COVID antibody treatment, mystifying doctors
Houston architect Lanson Jones is one of the nearly 80 million Americans who refuse to get a COVID-19 vaccine, arguing the shots are experimental, were rushed to market, may cause side effects, and aren’t all fully approved by federal officials.
But when he contracted COVID in September, he didn’t hesitate to seek treatment with monoclonal antibodies -- a year-old, laboratory-created therapy no less experimental than the vaccines that is not fully approved by the FDA and can also cause rare side effects.
“I haven’t done the shot because I hear a lot -- a lot -- of information about what are some of the effects of these vaccines and how it’s really not being reported, and I just felt I didn’t want to put something in me that has some question,” says Mr. Jones, 65.
“But with this monoclonal antibody treatment, I didn’t hesitate. I had no doubt in my mind -- not even one ounce of doubt about it. Not one person said, ‘Oh, well some people have had a reaction to it.’”
Mr. Jones, who was treated at Houston Methodist Hospital, is one of more than a million Americans who have received antibody IVs after getting the virus.
Those numbers are growing, with the federal government recently taking over distribution of the supplies of the drugs, which are limited in many states.
The treatment has been effective against COVID, in helping patients recover, stay out of the hospital, or die from the illness.
But what doctors and public health experts say is most surprising is that , as well.
“I think it’s irrational, quite frankly, if you have to boil it down to one word,” says Howard Huang, MD, who heads up Houston Methodist’s infusion program, which is providing up to 900 doses a week. “It really doesn’t make any sense on multiple levels.”
For one thing, he says, the FDA has just granted full approval for the COVID vaccine produced by Pfizer and BioNTech, upgrading its status from its emergency use authorization (EUA). Many experts expect the FDA to grant similar full approvals to the Moderna vaccine and possibly the Johnson and Johnson shot, which currently have EUA designations.
Many vaccine holdouts have cited the EUA status of the COVID vaccines -- one step shy of full approval -- as a reason they don’t trust the shot. But the antibody treatments have also been granted only EUA approval, which hasn’t stopped vaccine-resistant Americans from seeking them.
“So, they’re refusing an FDA-approved and tested [vaccine], and then they’re seeking something that’s still under an FDA EUA,” says Dr. Huang. “I just don’t get it. I really don’t.”
Amesh Adalja, MD, an emerging infectious diseases specialist with the Johns Hopkins University Center for Health Security, calls it “paradoxical” thinking for vaccine holdouts to refuse a shot that boosts your natural antibodies to prevent COVID, but take an antibody drug to treat it after infection.
“I don’t understand it, I can’t,” he says. “But the pandemic has been politicized and … I think consistency is not something to expect from people who are thinking about this irrationally [and] for people engaging in these conspiracies about the vaccine.
“I do think the fact that people like Joe Rogan and Gov. Abbot and Donald Trump received the monoclonal antibodies does probably play a role in some of the thinking in some of these individuals.”
Terry Scoggin, CEO of Titus Regional Medical Center in Mount Pleasant, Tex., says even the hospital’s doctors have been shocked by the demand for the new therapy among unvaccinated Texans.
“It’s mind-blowing that there’s been such resistance to the vaccine, but that demand for the monoclonal antibodies is so high,” he says, noting only 47% of adults in the region have received at least one dose of the shot. That’s far below CDC estimates that say 75.2% of American adults have received one shot, while 64.7% are fully vaccinated.
“But our doctors believe in the monoclonal antibodies, so it’s a trust factor -- they trust our community physicians,” Mr. Scoggin says. “I’ve never put the two and two together about the fear of the vaccine vs. [lack of fear] of the treatment. But it’s really interesting.”
Treatments effective, costly
Like the COVID vaccines given to nearly 214 million Americans, the antibody treatments taken by more than 1 million in the United States are highly effective and cause only rare (and usually minor) side effects.
Federal health officials say the infusions have helped keep the U.S. death toll -- now about 2,000 per day-- from soaring even higher, even as vaccine hesitancy persists, particularly in Southern states.
The FDA first authorized monoclonal antibody drugs in November 2020 -- just weeks before the vaccines were approved. But their popularity has soared as the Delta variant of the virus that causes COVID-19 has surged in recent months.
Clinical trials show that the drugs can cut COVID-related hospitalization or death in high-risk patients by as much as 70%-80%. They also can prevent infection in healthy people who have been exposed to an infected person, according to research published this month in The New England Journal of Medicine.
Monoclonal antibodies have been used for decades to treat cancer, autoimmune disorders, and other diseases, with the FDA approving nearly 100 such treatments since 1994.
The FDA has granted EUA approvals to four antibody treatments for COVID-19.
A two-antibody drug combination from Regeneron -- containing casirivimab and imdevimab -- has been shown to reduce the risk of hospitalization and death by 70% in people infected with COVID. Sotrovimab, made by GlaxoSmithKline and Vir, has had similar results.
The FDA approved a third treatment -- Eli Lilly’s combination of bamlanivimab and etesevimab -- in 2020, but the agency recommended against its use earlier this year after it proved ineffective against the Delta variant. The combination came back on the market in late August, but only in states where fewer than 5% of COVID infections are from strains, such as Delta, that are resistant to the treatment.
In June, the FDA authorized a fourth drug combination, Genentech’s tocilizumab, for people already hospitalized with COVID. But it is only moderately effective against the disease.
Lab-made monoclonal antibodies mimic the antibodies the body makes to fight viruses and illnesses. They work by targeting the spike protein on the surface of the virus. COVID vaccines work by priming the body’s immune system to recognize this very same spike protein and block it from entering your body’s cells, preventing infection.
Antibody treatments are given as an IV to treat an infection but can also be given as shots into the belly for people who have been exposed to the virus but have not yet been sickened by it, Dr. Huang says.
Timing is critical, he says, noting antibodies are most effective when given in the first few days after symptoms emerge.
Demands, concerns on the rise
Orders for monoclonal antibodies have skyrocketed in recent weeks -- to 168,000 doses per week in late August, up from 27,000 in July. The Biden administration, which has been covering the cost of the treatment for most patients, took over its distribution as well this week.
But experts foresee potential problems as patient demand increases.
Federal officials have already warned states of potential shortages ahead. Only about 2.4 million monoclonal antibody doses have been shipped nationally so far, less than half of which have been administered.
More supplies are on the way, with the federal government recently buying another 1.8 million doses for delivery in the months ahead. But for now, some hospitals are uncertain of supplies and are already struggling to meet the demand for the treatments.
Seven Southern states account for 70% of orders: Texas, Alabama, Florida, Mississippi, Tennessee, Georgia, and Louisiana. Those states have among the nation’s lowest vaccine rates and highest infection numbers.
Florida officials said the state’s latest weekly allotment left clinics 41,000 doses short of what they need. Tennessee has begun limiting treatments for unvaccinated patients to give priority to those most at risk of dying from COVID. And in Texas, elective surgeries have been postponed to make room for COVID-19 patients at some hospitals, as operating room nurses have been enlisted to give IVs.
Some strong proponents of monoclonal antibody treatments have been frustrated by Republican governors who are scrambling to push and deliver them, while opposing vaccine and mask mandates.
Raising vaccination rates, scientists say, would make the antibody treatments unnecessary in many cases.
Experts also note the drugs are far more costly than the vaccines -- with a price tag of about $2,100 for each IV, compared to $20-$40 for the shot.
“When you’re talking about just the cost to society as a whole -- turning down a [vaccine] that costs a couple dozen dollars for therapies that cost thousands of dollars -- it just doesn’t make any sense,” says Dr. Huang.
“And the tragedy is that a lot of these infections right now are preventable. It’s not like the pre-vaccine days, when we didn’t have anything better. And for these people, it’s just hard to justify that line of thinking. And so, the challenge is changing people’s minds. And that’s really been the difficult thing.”
In addition, the treatments take 90 minutes to administer, taxing health care workers in hard-hit states that have been slammed by the influx of patients.
Beyond these issues, Dr. Huang cites other public health costs of people choosing treatment over vaccination. The vaccine protects others because it limits transmission of the virus. By contrast, a single antibody IV helps only that patient and does not keep people from infecting others or becoming reinfected, requiring another IV.
“Getting the vaccine helps people beyond yourself; it helps the community, too,” he notes. “There’s just a strong argument for getting the vaccine. I obviously have a very biased opinion, but I would hope I have more of a scientific or expert opinion, but that doesn’t seem to matter these days.”
Vaccine resistance still remains for some
Seth Thurman, an IT technician from Mount Pleasant, Tex., acknowledges he was hesitant to get the vaccine at first because he felt it was fast-tracked, “experimental,” might cause unknown side effects, was developed quickly, and was being pushed by government officials.
“I shared the same sentiments as a lot of other people [as] some of the reasons why I might have been hesitant in the beginning to get the vaccine, says Mr. Thurman, 47. “A lot of people don’t trust what’s out there, maybe what the government is pushing, so I was taking a wait-and-see approach.”
In August, he relented and received the first of the two-shot Moderna vaccine. But several weeks later, he developed COVID and took his doctor’s advice to receive antibody therapy at Titus Regional Medical Center.
The results were almost immediate.
“I noticed within just a few hours of getting that infusion I was feeling better,” he says. “And by the next day, I was feeling great. No more temperature and no cough and no loss of taste and smell. And today, I’m 100%.”
Having had COVID convinced him of the importance of getting the vaccine, and he plans to get the second dose of the shot after the prescribed 90-day waiting period.
But Mr. Jones, the Houston architect, remains unconvinced, even after suffering what he describes as a “horrible” experience with COVID.
“It’s something I’m still thinking about,” he says of the vaccine. “But I can’t imagine that there wouldn’t be some sort of side effects from something that was developed so fast and had not gone through 4 or 5 years of vetting or trials. So that kind of just leaves doubt in my mind.
“And it’s just so weird that something so personal has become so public -- like people’s medical decisions now are on the front page of The New York Times. When did we think something like that would ever happen?”
The quick results of his treatment were so “remarkable” that he’d recommend it to anyone without hesitation, he says.
“If my story can help people be willing to seek out this infusion and take it early on in their COVID experience, I think it would not only save lives and keep people out of our hospitals and not overwhelm our hospital systems,” he says.
Dr. Huang agrees that the IV therapy is a great “fallback option” for people who’ve been infected, who have weakened immune systems, or can’t receive the vaccine for other health reasons. But for most people, he argues, the vaccine is the best way to go. That’s why Houston Methodist advises the shot for every patient like Mr. Jones, who’s been treated for COVID.
“Getting the vaccine is the way to go for the vast number of people,” he says.
Frederick Thurmond, MD, who oversees COVID-related care at Titus Regional Medical Center, believes it will take more than just doctors’ recommendations to move some patients to get the vaccine. The only thing that will motivate some will be contracting COVID, or knowing someone who does, he says.
“It’s clear that at least here in Texas, I swear man, you tell people they need to do something, and they just say, ‘Well, then I’m NOT going to do it,’” he says. “But once you’ve got COVID, the game becomes a whole lot more serious. And I think most people in the U.S. know someone who’s died from COVID at this point.”
Dr. Thurmond says that for some patients, stubborn resistance to legitimate medical advice persists -- on the vaccine and even treatment -- even after infection.
“We have seen more than one person avoid any medical care whatsoever after they knew they had COVID,” he says. “They languish in private and eventually come to the emergency room extremely sick and doing things with little to no medical value -- such as taking a friend’s hydroxychloroquine, random antibiotics, a horse de-worming dose of ivermectin, and gargling with Betadine and even bleach.”
But most of his patients who have the IV therapy take his advice to get the vaccine afterward.
“The only way to end the pandemic is to vaccinate everybody,” he says.
Dr. Adalja agrees.
“The monoclonal antibodies work, they are great drugs, so I think it is appropriate to praise them,” says Dr. Adalja, who’s given them to his own patients. “But it’s not appropriate to use them as an alternative to vaccination or to think, you know, don’t worry about the getting the vaccine because if you get infected and get the monoclonal antibodies to get through this -- that’s not the way to approach it.
He also worries about what he calls “dark-age mentalities” that have fueled the anti-vaccine movement, which has sought to heighten fears of modern medicine and doctors.
“The anti-vaccine movement has really capitalized on COVID-19, and it’s really a much more virulent form of the anti-vaccine movement than what we’ve seen with measles and other diseases in the past,” he notes. “And I think it’s going to be very difficult to contend with in the future, because no one thought we’d be battling the anti-vaccine movement this late in the pandemic.”
The biggest takeaway?
“When it comes to an infectious disease, prevention is always much better than treatment,” Dr. Adalja says. “If you don’t even need to get to the treatment stage because you prevent people from getting infected, that’s the goal.”
A version of this article first appeared on WebMD.com.
Houston architect Lanson Jones is one of the nearly 80 million Americans who refuse to get a COVID-19 vaccine, arguing the shots are experimental, were rushed to market, may cause side effects, and aren’t all fully approved by federal officials.
But when he contracted COVID in September, he didn’t hesitate to seek treatment with monoclonal antibodies -- a year-old, laboratory-created therapy no less experimental than the vaccines that is not fully approved by the FDA and can also cause rare side effects.
“I haven’t done the shot because I hear a lot -- a lot -- of information about what are some of the effects of these vaccines and how it’s really not being reported, and I just felt I didn’t want to put something in me that has some question,” says Mr. Jones, 65.
“But with this monoclonal antibody treatment, I didn’t hesitate. I had no doubt in my mind -- not even one ounce of doubt about it. Not one person said, ‘Oh, well some people have had a reaction to it.’”
Mr. Jones, who was treated at Houston Methodist Hospital, is one of more than a million Americans who have received antibody IVs after getting the virus.
Those numbers are growing, with the federal government recently taking over distribution of the supplies of the drugs, which are limited in many states.
The treatment has been effective against COVID, in helping patients recover, stay out of the hospital, or die from the illness.
But what doctors and public health experts say is most surprising is that , as well.
“I think it’s irrational, quite frankly, if you have to boil it down to one word,” says Howard Huang, MD, who heads up Houston Methodist’s infusion program, which is providing up to 900 doses a week. “It really doesn’t make any sense on multiple levels.”
For one thing, he says, the FDA has just granted full approval for the COVID vaccine produced by Pfizer and BioNTech, upgrading its status from its emergency use authorization (EUA). Many experts expect the FDA to grant similar full approvals to the Moderna vaccine and possibly the Johnson and Johnson shot, which currently have EUA designations.
Many vaccine holdouts have cited the EUA status of the COVID vaccines -- one step shy of full approval -- as a reason they don’t trust the shot. But the antibody treatments have also been granted only EUA approval, which hasn’t stopped vaccine-resistant Americans from seeking them.
“So, they’re refusing an FDA-approved and tested [vaccine], and then they’re seeking something that’s still under an FDA EUA,” says Dr. Huang. “I just don’t get it. I really don’t.”
Amesh Adalja, MD, an emerging infectious diseases specialist with the Johns Hopkins University Center for Health Security, calls it “paradoxical” thinking for vaccine holdouts to refuse a shot that boosts your natural antibodies to prevent COVID, but take an antibody drug to treat it after infection.
“I don’t understand it, I can’t,” he says. “But the pandemic has been politicized and … I think consistency is not something to expect from people who are thinking about this irrationally [and] for people engaging in these conspiracies about the vaccine.
“I do think the fact that people like Joe Rogan and Gov. Abbot and Donald Trump received the monoclonal antibodies does probably play a role in some of the thinking in some of these individuals.”
Terry Scoggin, CEO of Titus Regional Medical Center in Mount Pleasant, Tex., says even the hospital’s doctors have been shocked by the demand for the new therapy among unvaccinated Texans.
“It’s mind-blowing that there’s been such resistance to the vaccine, but that demand for the monoclonal antibodies is so high,” he says, noting only 47% of adults in the region have received at least one dose of the shot. That’s far below CDC estimates that say 75.2% of American adults have received one shot, while 64.7% are fully vaccinated.
“But our doctors believe in the monoclonal antibodies, so it’s a trust factor -- they trust our community physicians,” Mr. Scoggin says. “I’ve never put the two and two together about the fear of the vaccine vs. [lack of fear] of the treatment. But it’s really interesting.”
Treatments effective, costly
Like the COVID vaccines given to nearly 214 million Americans, the antibody treatments taken by more than 1 million in the United States are highly effective and cause only rare (and usually minor) side effects.
Federal health officials say the infusions have helped keep the U.S. death toll -- now about 2,000 per day-- from soaring even higher, even as vaccine hesitancy persists, particularly in Southern states.
The FDA first authorized monoclonal antibody drugs in November 2020 -- just weeks before the vaccines were approved. But their popularity has soared as the Delta variant of the virus that causes COVID-19 has surged in recent months.
Clinical trials show that the drugs can cut COVID-related hospitalization or death in high-risk patients by as much as 70%-80%. They also can prevent infection in healthy people who have been exposed to an infected person, according to research published this month in The New England Journal of Medicine.
Monoclonal antibodies have been used for decades to treat cancer, autoimmune disorders, and other diseases, with the FDA approving nearly 100 such treatments since 1994.
The FDA has granted EUA approvals to four antibody treatments for COVID-19.
A two-antibody drug combination from Regeneron -- containing casirivimab and imdevimab -- has been shown to reduce the risk of hospitalization and death by 70% in people infected with COVID. Sotrovimab, made by GlaxoSmithKline and Vir, has had similar results.
The FDA approved a third treatment -- Eli Lilly’s combination of bamlanivimab and etesevimab -- in 2020, but the agency recommended against its use earlier this year after it proved ineffective against the Delta variant. The combination came back on the market in late August, but only in states where fewer than 5% of COVID infections are from strains, such as Delta, that are resistant to the treatment.
In June, the FDA authorized a fourth drug combination, Genentech’s tocilizumab, for people already hospitalized with COVID. But it is only moderately effective against the disease.
Lab-made monoclonal antibodies mimic the antibodies the body makes to fight viruses and illnesses. They work by targeting the spike protein on the surface of the virus. COVID vaccines work by priming the body’s immune system to recognize this very same spike protein and block it from entering your body’s cells, preventing infection.
Antibody treatments are given as an IV to treat an infection but can also be given as shots into the belly for people who have been exposed to the virus but have not yet been sickened by it, Dr. Huang says.
Timing is critical, he says, noting antibodies are most effective when given in the first few days after symptoms emerge.
Demands, concerns on the rise
Orders for monoclonal antibodies have skyrocketed in recent weeks -- to 168,000 doses per week in late August, up from 27,000 in July. The Biden administration, which has been covering the cost of the treatment for most patients, took over its distribution as well this week.
But experts foresee potential problems as patient demand increases.
Federal officials have already warned states of potential shortages ahead. Only about 2.4 million monoclonal antibody doses have been shipped nationally so far, less than half of which have been administered.
More supplies are on the way, with the federal government recently buying another 1.8 million doses for delivery in the months ahead. But for now, some hospitals are uncertain of supplies and are already struggling to meet the demand for the treatments.
Seven Southern states account for 70% of orders: Texas, Alabama, Florida, Mississippi, Tennessee, Georgia, and Louisiana. Those states have among the nation’s lowest vaccine rates and highest infection numbers.
Florida officials said the state’s latest weekly allotment left clinics 41,000 doses short of what they need. Tennessee has begun limiting treatments for unvaccinated patients to give priority to those most at risk of dying from COVID. And in Texas, elective surgeries have been postponed to make room for COVID-19 patients at some hospitals, as operating room nurses have been enlisted to give IVs.
Some strong proponents of monoclonal antibody treatments have been frustrated by Republican governors who are scrambling to push and deliver them, while opposing vaccine and mask mandates.
Raising vaccination rates, scientists say, would make the antibody treatments unnecessary in many cases.
Experts also note the drugs are far more costly than the vaccines -- with a price tag of about $2,100 for each IV, compared to $20-$40 for the shot.
“When you’re talking about just the cost to society as a whole -- turning down a [vaccine] that costs a couple dozen dollars for therapies that cost thousands of dollars -- it just doesn’t make any sense,” says Dr. Huang.
“And the tragedy is that a lot of these infections right now are preventable. It’s not like the pre-vaccine days, when we didn’t have anything better. And for these people, it’s just hard to justify that line of thinking. And so, the challenge is changing people’s minds. And that’s really been the difficult thing.”
In addition, the treatments take 90 minutes to administer, taxing health care workers in hard-hit states that have been slammed by the influx of patients.
Beyond these issues, Dr. Huang cites other public health costs of people choosing treatment over vaccination. The vaccine protects others because it limits transmission of the virus. By contrast, a single antibody IV helps only that patient and does not keep people from infecting others or becoming reinfected, requiring another IV.
“Getting the vaccine helps people beyond yourself; it helps the community, too,” he notes. “There’s just a strong argument for getting the vaccine. I obviously have a very biased opinion, but I would hope I have more of a scientific or expert opinion, but that doesn’t seem to matter these days.”
Vaccine resistance still remains for some
Seth Thurman, an IT technician from Mount Pleasant, Tex., acknowledges he was hesitant to get the vaccine at first because he felt it was fast-tracked, “experimental,” might cause unknown side effects, was developed quickly, and was being pushed by government officials.
“I shared the same sentiments as a lot of other people [as] some of the reasons why I might have been hesitant in the beginning to get the vaccine, says Mr. Thurman, 47. “A lot of people don’t trust what’s out there, maybe what the government is pushing, so I was taking a wait-and-see approach.”
In August, he relented and received the first of the two-shot Moderna vaccine. But several weeks later, he developed COVID and took his doctor’s advice to receive antibody therapy at Titus Regional Medical Center.
The results were almost immediate.
“I noticed within just a few hours of getting that infusion I was feeling better,” he says. “And by the next day, I was feeling great. No more temperature and no cough and no loss of taste and smell. And today, I’m 100%.”
Having had COVID convinced him of the importance of getting the vaccine, and he plans to get the second dose of the shot after the prescribed 90-day waiting period.
But Mr. Jones, the Houston architect, remains unconvinced, even after suffering what he describes as a “horrible” experience with COVID.
“It’s something I’m still thinking about,” he says of the vaccine. “But I can’t imagine that there wouldn’t be some sort of side effects from something that was developed so fast and had not gone through 4 or 5 years of vetting or trials. So that kind of just leaves doubt in my mind.
“And it’s just so weird that something so personal has become so public -- like people’s medical decisions now are on the front page of The New York Times. When did we think something like that would ever happen?”
The quick results of his treatment were so “remarkable” that he’d recommend it to anyone without hesitation, he says.
“If my story can help people be willing to seek out this infusion and take it early on in their COVID experience, I think it would not only save lives and keep people out of our hospitals and not overwhelm our hospital systems,” he says.
Dr. Huang agrees that the IV therapy is a great “fallback option” for people who’ve been infected, who have weakened immune systems, or can’t receive the vaccine for other health reasons. But for most people, he argues, the vaccine is the best way to go. That’s why Houston Methodist advises the shot for every patient like Mr. Jones, who’s been treated for COVID.
“Getting the vaccine is the way to go for the vast number of people,” he says.
Frederick Thurmond, MD, who oversees COVID-related care at Titus Regional Medical Center, believes it will take more than just doctors’ recommendations to move some patients to get the vaccine. The only thing that will motivate some will be contracting COVID, or knowing someone who does, he says.
“It’s clear that at least here in Texas, I swear man, you tell people they need to do something, and they just say, ‘Well, then I’m NOT going to do it,’” he says. “But once you’ve got COVID, the game becomes a whole lot more serious. And I think most people in the U.S. know someone who’s died from COVID at this point.”
Dr. Thurmond says that for some patients, stubborn resistance to legitimate medical advice persists -- on the vaccine and even treatment -- even after infection.
“We have seen more than one person avoid any medical care whatsoever after they knew they had COVID,” he says. “They languish in private and eventually come to the emergency room extremely sick and doing things with little to no medical value -- such as taking a friend’s hydroxychloroquine, random antibiotics, a horse de-worming dose of ivermectin, and gargling with Betadine and even bleach.”
But most of his patients who have the IV therapy take his advice to get the vaccine afterward.
“The only way to end the pandemic is to vaccinate everybody,” he says.
Dr. Adalja agrees.
“The monoclonal antibodies work, they are great drugs, so I think it is appropriate to praise them,” says Dr. Adalja, who’s given them to his own patients. “But it’s not appropriate to use them as an alternative to vaccination or to think, you know, don’t worry about the getting the vaccine because if you get infected and get the monoclonal antibodies to get through this -- that’s not the way to approach it.
He also worries about what he calls “dark-age mentalities” that have fueled the anti-vaccine movement, which has sought to heighten fears of modern medicine and doctors.
“The anti-vaccine movement has really capitalized on COVID-19, and it’s really a much more virulent form of the anti-vaccine movement than what we’ve seen with measles and other diseases in the past,” he notes. “And I think it’s going to be very difficult to contend with in the future, because no one thought we’d be battling the anti-vaccine movement this late in the pandemic.”
The biggest takeaway?
“When it comes to an infectious disease, prevention is always much better than treatment,” Dr. Adalja says. “If you don’t even need to get to the treatment stage because you prevent people from getting infected, that’s the goal.”
A version of this article first appeared on WebMD.com.
Houston architect Lanson Jones is one of the nearly 80 million Americans who refuse to get a COVID-19 vaccine, arguing the shots are experimental, were rushed to market, may cause side effects, and aren’t all fully approved by federal officials.
But when he contracted COVID in September, he didn’t hesitate to seek treatment with monoclonal antibodies -- a year-old, laboratory-created therapy no less experimental than the vaccines that is not fully approved by the FDA and can also cause rare side effects.
“I haven’t done the shot because I hear a lot -- a lot -- of information about what are some of the effects of these vaccines and how it’s really not being reported, and I just felt I didn’t want to put something in me that has some question,” says Mr. Jones, 65.
“But with this monoclonal antibody treatment, I didn’t hesitate. I had no doubt in my mind -- not even one ounce of doubt about it. Not one person said, ‘Oh, well some people have had a reaction to it.’”
Mr. Jones, who was treated at Houston Methodist Hospital, is one of more than a million Americans who have received antibody IVs after getting the virus.
Those numbers are growing, with the federal government recently taking over distribution of the supplies of the drugs, which are limited in many states.
The treatment has been effective against COVID, in helping patients recover, stay out of the hospital, or die from the illness.
But what doctors and public health experts say is most surprising is that , as well.
“I think it’s irrational, quite frankly, if you have to boil it down to one word,” says Howard Huang, MD, who heads up Houston Methodist’s infusion program, which is providing up to 900 doses a week. “It really doesn’t make any sense on multiple levels.”
For one thing, he says, the FDA has just granted full approval for the COVID vaccine produced by Pfizer and BioNTech, upgrading its status from its emergency use authorization (EUA). Many experts expect the FDA to grant similar full approvals to the Moderna vaccine and possibly the Johnson and Johnson shot, which currently have EUA designations.
Many vaccine holdouts have cited the EUA status of the COVID vaccines -- one step shy of full approval -- as a reason they don’t trust the shot. But the antibody treatments have also been granted only EUA approval, which hasn’t stopped vaccine-resistant Americans from seeking them.
“So, they’re refusing an FDA-approved and tested [vaccine], and then they’re seeking something that’s still under an FDA EUA,” says Dr. Huang. “I just don’t get it. I really don’t.”
Amesh Adalja, MD, an emerging infectious diseases specialist with the Johns Hopkins University Center for Health Security, calls it “paradoxical” thinking for vaccine holdouts to refuse a shot that boosts your natural antibodies to prevent COVID, but take an antibody drug to treat it after infection.
“I don’t understand it, I can’t,” he says. “But the pandemic has been politicized and … I think consistency is not something to expect from people who are thinking about this irrationally [and] for people engaging in these conspiracies about the vaccine.
“I do think the fact that people like Joe Rogan and Gov. Abbot and Donald Trump received the monoclonal antibodies does probably play a role in some of the thinking in some of these individuals.”
Terry Scoggin, CEO of Titus Regional Medical Center in Mount Pleasant, Tex., says even the hospital’s doctors have been shocked by the demand for the new therapy among unvaccinated Texans.
“It’s mind-blowing that there’s been such resistance to the vaccine, but that demand for the monoclonal antibodies is so high,” he says, noting only 47% of adults in the region have received at least one dose of the shot. That’s far below CDC estimates that say 75.2% of American adults have received one shot, while 64.7% are fully vaccinated.
“But our doctors believe in the monoclonal antibodies, so it’s a trust factor -- they trust our community physicians,” Mr. Scoggin says. “I’ve never put the two and two together about the fear of the vaccine vs. [lack of fear] of the treatment. But it’s really interesting.”
Treatments effective, costly
Like the COVID vaccines given to nearly 214 million Americans, the antibody treatments taken by more than 1 million in the United States are highly effective and cause only rare (and usually minor) side effects.
Federal health officials say the infusions have helped keep the U.S. death toll -- now about 2,000 per day-- from soaring even higher, even as vaccine hesitancy persists, particularly in Southern states.
The FDA first authorized monoclonal antibody drugs in November 2020 -- just weeks before the vaccines were approved. But their popularity has soared as the Delta variant of the virus that causes COVID-19 has surged in recent months.
Clinical trials show that the drugs can cut COVID-related hospitalization or death in high-risk patients by as much as 70%-80%. They also can prevent infection in healthy people who have been exposed to an infected person, according to research published this month in The New England Journal of Medicine.
Monoclonal antibodies have been used for decades to treat cancer, autoimmune disorders, and other diseases, with the FDA approving nearly 100 such treatments since 1994.
The FDA has granted EUA approvals to four antibody treatments for COVID-19.
A two-antibody drug combination from Regeneron -- containing casirivimab and imdevimab -- has been shown to reduce the risk of hospitalization and death by 70% in people infected with COVID. Sotrovimab, made by GlaxoSmithKline and Vir, has had similar results.
The FDA approved a third treatment -- Eli Lilly’s combination of bamlanivimab and etesevimab -- in 2020, but the agency recommended against its use earlier this year after it proved ineffective against the Delta variant. The combination came back on the market in late August, but only in states where fewer than 5% of COVID infections are from strains, such as Delta, that are resistant to the treatment.
In June, the FDA authorized a fourth drug combination, Genentech’s tocilizumab, for people already hospitalized with COVID. But it is only moderately effective against the disease.
Lab-made monoclonal antibodies mimic the antibodies the body makes to fight viruses and illnesses. They work by targeting the spike protein on the surface of the virus. COVID vaccines work by priming the body’s immune system to recognize this very same spike protein and block it from entering your body’s cells, preventing infection.
Antibody treatments are given as an IV to treat an infection but can also be given as shots into the belly for people who have been exposed to the virus but have not yet been sickened by it, Dr. Huang says.
Timing is critical, he says, noting antibodies are most effective when given in the first few days after symptoms emerge.
Demands, concerns on the rise
Orders for monoclonal antibodies have skyrocketed in recent weeks -- to 168,000 doses per week in late August, up from 27,000 in July. The Biden administration, which has been covering the cost of the treatment for most patients, took over its distribution as well this week.
But experts foresee potential problems as patient demand increases.
Federal officials have already warned states of potential shortages ahead. Only about 2.4 million monoclonal antibody doses have been shipped nationally so far, less than half of which have been administered.
More supplies are on the way, with the federal government recently buying another 1.8 million doses for delivery in the months ahead. But for now, some hospitals are uncertain of supplies and are already struggling to meet the demand for the treatments.
Seven Southern states account for 70% of orders: Texas, Alabama, Florida, Mississippi, Tennessee, Georgia, and Louisiana. Those states have among the nation’s lowest vaccine rates and highest infection numbers.
Florida officials said the state’s latest weekly allotment left clinics 41,000 doses short of what they need. Tennessee has begun limiting treatments for unvaccinated patients to give priority to those most at risk of dying from COVID. And in Texas, elective surgeries have been postponed to make room for COVID-19 patients at some hospitals, as operating room nurses have been enlisted to give IVs.
Some strong proponents of monoclonal antibody treatments have been frustrated by Republican governors who are scrambling to push and deliver them, while opposing vaccine and mask mandates.
Raising vaccination rates, scientists say, would make the antibody treatments unnecessary in many cases.
Experts also note the drugs are far more costly than the vaccines -- with a price tag of about $2,100 for each IV, compared to $20-$40 for the shot.
“When you’re talking about just the cost to society as a whole -- turning down a [vaccine] that costs a couple dozen dollars for therapies that cost thousands of dollars -- it just doesn’t make any sense,” says Dr. Huang.
“And the tragedy is that a lot of these infections right now are preventable. It’s not like the pre-vaccine days, when we didn’t have anything better. And for these people, it’s just hard to justify that line of thinking. And so, the challenge is changing people’s minds. And that’s really been the difficult thing.”
In addition, the treatments take 90 minutes to administer, taxing health care workers in hard-hit states that have been slammed by the influx of patients.
Beyond these issues, Dr. Huang cites other public health costs of people choosing treatment over vaccination. The vaccine protects others because it limits transmission of the virus. By contrast, a single antibody IV helps only that patient and does not keep people from infecting others or becoming reinfected, requiring another IV.
“Getting the vaccine helps people beyond yourself; it helps the community, too,” he notes. “There’s just a strong argument for getting the vaccine. I obviously have a very biased opinion, but I would hope I have more of a scientific or expert opinion, but that doesn’t seem to matter these days.”
Vaccine resistance still remains for some
Seth Thurman, an IT technician from Mount Pleasant, Tex., acknowledges he was hesitant to get the vaccine at first because he felt it was fast-tracked, “experimental,” might cause unknown side effects, was developed quickly, and was being pushed by government officials.
“I shared the same sentiments as a lot of other people [as] some of the reasons why I might have been hesitant in the beginning to get the vaccine, says Mr. Thurman, 47. “A lot of people don’t trust what’s out there, maybe what the government is pushing, so I was taking a wait-and-see approach.”
In August, he relented and received the first of the two-shot Moderna vaccine. But several weeks later, he developed COVID and took his doctor’s advice to receive antibody therapy at Titus Regional Medical Center.
The results were almost immediate.
“I noticed within just a few hours of getting that infusion I was feeling better,” he says. “And by the next day, I was feeling great. No more temperature and no cough and no loss of taste and smell. And today, I’m 100%.”
Having had COVID convinced him of the importance of getting the vaccine, and he plans to get the second dose of the shot after the prescribed 90-day waiting period.
But Mr. Jones, the Houston architect, remains unconvinced, even after suffering what he describes as a “horrible” experience with COVID.
“It’s something I’m still thinking about,” he says of the vaccine. “But I can’t imagine that there wouldn’t be some sort of side effects from something that was developed so fast and had not gone through 4 or 5 years of vetting or trials. So that kind of just leaves doubt in my mind.
“And it’s just so weird that something so personal has become so public -- like people’s medical decisions now are on the front page of The New York Times. When did we think something like that would ever happen?”
The quick results of his treatment were so “remarkable” that he’d recommend it to anyone without hesitation, he says.
“If my story can help people be willing to seek out this infusion and take it early on in their COVID experience, I think it would not only save lives and keep people out of our hospitals and not overwhelm our hospital systems,” he says.
Dr. Huang agrees that the IV therapy is a great “fallback option” for people who’ve been infected, who have weakened immune systems, or can’t receive the vaccine for other health reasons. But for most people, he argues, the vaccine is the best way to go. That’s why Houston Methodist advises the shot for every patient like Mr. Jones, who’s been treated for COVID.
“Getting the vaccine is the way to go for the vast number of people,” he says.
Frederick Thurmond, MD, who oversees COVID-related care at Titus Regional Medical Center, believes it will take more than just doctors’ recommendations to move some patients to get the vaccine. The only thing that will motivate some will be contracting COVID, or knowing someone who does, he says.
“It’s clear that at least here in Texas, I swear man, you tell people they need to do something, and they just say, ‘Well, then I’m NOT going to do it,’” he says. “But once you’ve got COVID, the game becomes a whole lot more serious. And I think most people in the U.S. know someone who’s died from COVID at this point.”
Dr. Thurmond says that for some patients, stubborn resistance to legitimate medical advice persists -- on the vaccine and even treatment -- even after infection.
“We have seen more than one person avoid any medical care whatsoever after they knew they had COVID,” he says. “They languish in private and eventually come to the emergency room extremely sick and doing things with little to no medical value -- such as taking a friend’s hydroxychloroquine, random antibiotics, a horse de-worming dose of ivermectin, and gargling with Betadine and even bleach.”
But most of his patients who have the IV therapy take his advice to get the vaccine afterward.
“The only way to end the pandemic is to vaccinate everybody,” he says.
Dr. Adalja agrees.
“The monoclonal antibodies work, they are great drugs, so I think it is appropriate to praise them,” says Dr. Adalja, who’s given them to his own patients. “But it’s not appropriate to use them as an alternative to vaccination or to think, you know, don’t worry about the getting the vaccine because if you get infected and get the monoclonal antibodies to get through this -- that’s not the way to approach it.
He also worries about what he calls “dark-age mentalities” that have fueled the anti-vaccine movement, which has sought to heighten fears of modern medicine and doctors.
“The anti-vaccine movement has really capitalized on COVID-19, and it’s really a much more virulent form of the anti-vaccine movement than what we’ve seen with measles and other diseases in the past,” he notes. “And I think it’s going to be very difficult to contend with in the future, because no one thought we’d be battling the anti-vaccine movement this late in the pandemic.”
The biggest takeaway?
“When it comes to an infectious disease, prevention is always much better than treatment,” Dr. Adalja says. “If you don’t even need to get to the treatment stage because you prevent people from getting infected, that’s the goal.”
A version of this article first appeared on WebMD.com.
Opioid prescribing mapped: Alabama highest, New York lowest
Medicare beneficiaries in Alabama were more likely to get a prescription for an opioid than in any other state in 2019, based on newly released data.
That year, opioids represented 6.48% of all drug claims for part D enrollees in the state, just ahead of Utah at 6.41%. Idaho, at 6.07%, was the only other state with an opioid prescribing rate over 6%, while Oklahoma came in at an even 6.0%, according to the latest update of the Centers for Medicare & Medicaid Services’ dataset.
The lowest rate in 2019 belonged to New York, where 2.51% of drug claims, including original prescriptions and refills, involved an opioid. Rhode Island was next at 2.87%, followed by New Jersey (3.23%), Massachusetts (3.26%), and North Dakota (3.39%),
Altogether, Medicare part D processed 1.5 billion drug claims in 2019, of which 66.1 million, or 4.41%, involved opioids. Both of the opioid numbers were down from 2018, when opioids represented 4.68% (70.2 million) of the 1.5 billion total claims, and from 2014, when opioids were involved in 5.73% (81,026,831) of the 1.41 billion drug claims, the CMS data show. That works out to 5.77% fewer opioids in 2019, compared with 2014, despite the increase in total volume.
from 2014 to 2019, with Hawaii showing the smallest decline as it slipped 0.41 percentage points from 3.9% to 3.49%, according to the CMS.
In 2019, part D beneficiaries in Vermont were the most likely to receive a long-acting opioid, which accounted for 20.14% of all opioid prescriptions in the state, while Kentucky had the lowest share of prescriptions written for long-acting forms at 6.41%. The national average was 11.02%, dropping from 11.79% in 2018 and 12.75% in 2014, the CMS reported.
Medicare beneficiaries in Alabama were more likely to get a prescription for an opioid than in any other state in 2019, based on newly released data.
That year, opioids represented 6.48% of all drug claims for part D enrollees in the state, just ahead of Utah at 6.41%. Idaho, at 6.07%, was the only other state with an opioid prescribing rate over 6%, while Oklahoma came in at an even 6.0%, according to the latest update of the Centers for Medicare & Medicaid Services’ dataset.
The lowest rate in 2019 belonged to New York, where 2.51% of drug claims, including original prescriptions and refills, involved an opioid. Rhode Island was next at 2.87%, followed by New Jersey (3.23%), Massachusetts (3.26%), and North Dakota (3.39%),
Altogether, Medicare part D processed 1.5 billion drug claims in 2019, of which 66.1 million, or 4.41%, involved opioids. Both of the opioid numbers were down from 2018, when opioids represented 4.68% (70.2 million) of the 1.5 billion total claims, and from 2014, when opioids were involved in 5.73% (81,026,831) of the 1.41 billion drug claims, the CMS data show. That works out to 5.77% fewer opioids in 2019, compared with 2014, despite the increase in total volume.
from 2014 to 2019, with Hawaii showing the smallest decline as it slipped 0.41 percentage points from 3.9% to 3.49%, according to the CMS.
In 2019, part D beneficiaries in Vermont were the most likely to receive a long-acting opioid, which accounted for 20.14% of all opioid prescriptions in the state, while Kentucky had the lowest share of prescriptions written for long-acting forms at 6.41%. The national average was 11.02%, dropping from 11.79% in 2018 and 12.75% in 2014, the CMS reported.
Medicare beneficiaries in Alabama were more likely to get a prescription for an opioid than in any other state in 2019, based on newly released data.
That year, opioids represented 6.48% of all drug claims for part D enrollees in the state, just ahead of Utah at 6.41%. Idaho, at 6.07%, was the only other state with an opioid prescribing rate over 6%, while Oklahoma came in at an even 6.0%, according to the latest update of the Centers for Medicare & Medicaid Services’ dataset.
The lowest rate in 2019 belonged to New York, where 2.51% of drug claims, including original prescriptions and refills, involved an opioid. Rhode Island was next at 2.87%, followed by New Jersey (3.23%), Massachusetts (3.26%), and North Dakota (3.39%),
Altogether, Medicare part D processed 1.5 billion drug claims in 2019, of which 66.1 million, or 4.41%, involved opioids. Both of the opioid numbers were down from 2018, when opioids represented 4.68% (70.2 million) of the 1.5 billion total claims, and from 2014, when opioids were involved in 5.73% (81,026,831) of the 1.41 billion drug claims, the CMS data show. That works out to 5.77% fewer opioids in 2019, compared with 2014, despite the increase in total volume.
from 2014 to 2019, with Hawaii showing the smallest decline as it slipped 0.41 percentage points from 3.9% to 3.49%, according to the CMS.
In 2019, part D beneficiaries in Vermont were the most likely to receive a long-acting opioid, which accounted for 20.14% of all opioid prescriptions in the state, while Kentucky had the lowest share of prescriptions written for long-acting forms at 6.41%. The national average was 11.02%, dropping from 11.79% in 2018 and 12.75% in 2014, the CMS reported.
NIAMS director reflects on her mentors, spotlights research projects underway
After many years at the University of California, San Francisco, Lindsey A. Criswell, MD, MPH, DSc, began a new chapter in February 2021 as the director of the National Institute of Arthritis and Musculoskeletal and Skin Disease, part of the National Institutes of Health. NIH Director Francis S. Collins, MD, PhD, selected her for the post.
“Dr. Criswell has rich experience as a clinician, researcher, and administrator,” Dr. Collins said in a prepared statement. “Her ability to oversee the research program of one of the country’s top research-intensive medical schools, and her expertise in autoimmune diseases, including rheumatoid arthritis and lupus, make her well positioned to direct NIAMS.” Dr. Criswell, a rheumatologist, was named a full professor of medicine at UCSF in 2007 and had served as vice chancellor of research at the university since 2017. She has authored more than 250 peer-reviewed scientific papers, and her efforts have contributed to the identification of more than 30 genes linked to autoimmune disorders. In her first media interview, Dr. Criswell opens up about her mentors, operational challenges posed by the COVID-19 pandemic, and highlights many NIAMS research projects underway.
Who inspired you most early in your career as a physician scientist? I have had great opportunities to work with fabulous mentors. Wallace (Wally) Epstein, MD, was my mentor when I was a rheumatology fellow and junior faculty member at UCSF. He was broadly admired for the breadth of his experience as a clinician and a researcher, and he was noteworthy at that time for his strong support for women and students of color. One of the many things I appreciated about him was his diverse range of interests outside of work, which included cello playing and woodworking.
Another mentor was Ephraim (Eph) Engleman, MD, the first academic rheumatologist in California. Eph continued to see patients beyond the age of 100. Perhaps his most important contributions were his efforts towards advocacy for funding for research and education in rheumatology. A prodigy violinist, he too had a broad range of personal interests.
What research into the genetics and epidemiology of human autoimmune disease that you have been a part of has most surprised you, in term of its ultimate clinical impact? Some of my most rewarding and impactful work has focused on the shared genetic basis of autoimmune diseases. We’ve identified dozens of genes that contribute to the risk and outcome of rheumatoid arthritis, lupus, and other autoimmune disorders. These discoveries regarding shared genes and pathways among such a diverse set of conditions have helped to inform optimal therapeutic target and treatment strategies across multiple diseases. For example, exploration of RA genes and pathways has revealed that approved agents for other conditions, such as cancer, may be appropriately repurposed for the treatment of RA. These are critical observations that have the potential to dramatically accelerate progress in developing new therapies for autoimmune diseases, such as RA.
Did you have much interaction with Stephen I. Katz, MD, PhD, your longtime predecessor who passed away unexpectedly in 2018? If so, what do you remember most about him? I regret that I had very little interaction with Steve, but I am well aware of the impact he had on NIAMS, NIH, and the research enterprise overall. He inspired so many people in a personal way, and I am energized by the legacy that he left behind.
What are your goals for the early part of your tenure as the new director of NIAMS? An important goal is getting to know the NIAMS community and expanding my knowledge of the Institute’s musculoskeletal and skin portfolios. I am also conducting outreach to Institute/Center directors and other NIH leadership to increase opportunities for input and advice. In doing this, I am identifying shared research interests, best practices, and potential partners for possible future collaborations. Another important goal is to increase NIAMS’ visibility within and beyond NIH. Ultimately, I want to contribute to the great work of the Institute and improve the lives of people with rheumatic, musculoskeletal, and skin diseases.
How would you characterize your management style? I like to lead with a flat hierarchy and work collectively to address opportunities and challenges. I value team building and tend to tap a variety of perspectives and expertise at all levels to achieve consensus, where possible.
The Accelerating Medicines Partnership (AMP) program was launched in 2014, with projects in three disease areas including the autoimmune disorders RA and lupus. What are some recent highlights from this program with respect to RA and lupus? AMP RA/SLE was dedicated to identifying promising therapeutic targets for RA and systemic lupus erythematosus. AMP-funded researchers have applied cutting-edge technologies to study cells from the synovial tissues of the joints of people with RA, and from the kidneys of people with lupus nephritis. In 2014, studying tissues in patients where the disease is active was a novel approach, since most research was conducted in mouse models or human blood samples.
The AMP RA/SLE Network developed a rich dataset that is available to the research community. Investigators are now using the data to facilitate RA and lupus research. For example, using AMP data, NIAMS-supported researchers identified potential biomarkers that could help predict an imminent RA flare. Work from another NIAMS-supported group suggests that targeting the regulatory transcription factor HIF-1, which drives inflammation and tissue damage, might be an effective approach for treating renal injury in lupus.
The data generated are accessible to the scientific community through two NIH websites: the database of Genotypes and Phenotypes (dbGaP) and the Immunology Database and Analysis Portal (IMMPORT).
Given the success of AMP RA/SLE, NIH plans to launch an “AMP 2.0” later in 2021. The AMP Autoimmune and Immune-Mediated Diseases (AMP AIM) program will provide an opportunity to leverage the accomplishments of AMP RA/SLE to new conditions, including psoriatic spectrum diseases and Sjögren’s syndrome.
What are some recent highlights from NIAMS-supported research in skin diseases? NIAMS-supported investigators continue to make significant strides in our understanding of skin biology and disease. For example, researchers recently demonstrated that imiquimod, a drug used to treat precancerous skin lesions, can help mouse ear wounds heal without scarring.
Another team addressed the safety and potential benefit of Staphylococcus hominis A9, a bacterium isolated from healthy human skin, as a topical therapy for atopic dermatitis.
Moving forward, AMP AIM will refine and extend the single-cell analysis of tissues to additional diseases, including psoriasis, setting the stage for the discovery of new therapeutic targets for the disease.
How has the COVID-19 pandemic changed the landscape of research, at least for the short term? This is a once-in-a-century pandemic that none of us were fully prepared for. We understand that it has been particularly challenging for women scientists, scientists with young children, and trainees and junior faculty who are at critically important and vulnerable stages of their careers. There isn’t a lab or clinical setting that hasn’t been negatively impacted in some way.
During the pandemic, the NIH instituted administrative flexibilities to support the grantee community, including extensions in time. In addition, the agency has issued several funding opportunities specific to COVID-19, some of which involve NIAMS participation.
What is NIAMS doing to help early/young investigators as well as female investigators and those from minority groups? Structural racism in biomedical research is a heightened concern. Earlier this year, Dr. Collins established the UNITE initiative to address structural racism and promote racial equity and inclusion at the NIH and within the larger biomedical community that we support. NIAMS is fully committed to this effort. One example is the Diversity Supplement Program, which is designed to attract and encourage eligible individuals from underrepresented populations to research careers.
Early-stage investigators are another top priority. In a tribute to the beloved former NIAMS director, NIH recently established the Stephen I. Katz Early Stage Investigator Research Grant Program. The R01 award provides support for a project unrelated to an early investigator’s area of postdoctoral study. (No preliminary data are allowed.) This award mechanism is a unique opportunity for early-stage investigators to take their research in a completely new direction.
Managing work and family life is an important concern, particularly for female investigators. Many NIH grant awards allow for reimbursement of actual, allowable costs incurred for childcare and parental leave. The NIH is exploring initiatives to promote research continuity and retention of eligible investigators facing major life events, such as pregnancy, childbirth, and adoption, at vulnerable career stages.
Who inspires you most in your work today? I am inspired by the ongoing struggles of our patients, junior investigators, and by the committed staff members on my team.
After many years at the University of California, San Francisco, Lindsey A. Criswell, MD, MPH, DSc, began a new chapter in February 2021 as the director of the National Institute of Arthritis and Musculoskeletal and Skin Disease, part of the National Institutes of Health. NIH Director Francis S. Collins, MD, PhD, selected her for the post.
“Dr. Criswell has rich experience as a clinician, researcher, and administrator,” Dr. Collins said in a prepared statement. “Her ability to oversee the research program of one of the country’s top research-intensive medical schools, and her expertise in autoimmune diseases, including rheumatoid arthritis and lupus, make her well positioned to direct NIAMS.” Dr. Criswell, a rheumatologist, was named a full professor of medicine at UCSF in 2007 and had served as vice chancellor of research at the university since 2017. She has authored more than 250 peer-reviewed scientific papers, and her efforts have contributed to the identification of more than 30 genes linked to autoimmune disorders. In her first media interview, Dr. Criswell opens up about her mentors, operational challenges posed by the COVID-19 pandemic, and highlights many NIAMS research projects underway.
Who inspired you most early in your career as a physician scientist? I have had great opportunities to work with fabulous mentors. Wallace (Wally) Epstein, MD, was my mentor when I was a rheumatology fellow and junior faculty member at UCSF. He was broadly admired for the breadth of his experience as a clinician and a researcher, and he was noteworthy at that time for his strong support for women and students of color. One of the many things I appreciated about him was his diverse range of interests outside of work, which included cello playing and woodworking.
Another mentor was Ephraim (Eph) Engleman, MD, the first academic rheumatologist in California. Eph continued to see patients beyond the age of 100. Perhaps his most important contributions were his efforts towards advocacy for funding for research and education in rheumatology. A prodigy violinist, he too had a broad range of personal interests.
What research into the genetics and epidemiology of human autoimmune disease that you have been a part of has most surprised you, in term of its ultimate clinical impact? Some of my most rewarding and impactful work has focused on the shared genetic basis of autoimmune diseases. We’ve identified dozens of genes that contribute to the risk and outcome of rheumatoid arthritis, lupus, and other autoimmune disorders. These discoveries regarding shared genes and pathways among such a diverse set of conditions have helped to inform optimal therapeutic target and treatment strategies across multiple diseases. For example, exploration of RA genes and pathways has revealed that approved agents for other conditions, such as cancer, may be appropriately repurposed for the treatment of RA. These are critical observations that have the potential to dramatically accelerate progress in developing new therapies for autoimmune diseases, such as RA.
Did you have much interaction with Stephen I. Katz, MD, PhD, your longtime predecessor who passed away unexpectedly in 2018? If so, what do you remember most about him? I regret that I had very little interaction with Steve, but I am well aware of the impact he had on NIAMS, NIH, and the research enterprise overall. He inspired so many people in a personal way, and I am energized by the legacy that he left behind.
What are your goals for the early part of your tenure as the new director of NIAMS? An important goal is getting to know the NIAMS community and expanding my knowledge of the Institute’s musculoskeletal and skin portfolios. I am also conducting outreach to Institute/Center directors and other NIH leadership to increase opportunities for input and advice. In doing this, I am identifying shared research interests, best practices, and potential partners for possible future collaborations. Another important goal is to increase NIAMS’ visibility within and beyond NIH. Ultimately, I want to contribute to the great work of the Institute and improve the lives of people with rheumatic, musculoskeletal, and skin diseases.
How would you characterize your management style? I like to lead with a flat hierarchy and work collectively to address opportunities and challenges. I value team building and tend to tap a variety of perspectives and expertise at all levels to achieve consensus, where possible.
The Accelerating Medicines Partnership (AMP) program was launched in 2014, with projects in three disease areas including the autoimmune disorders RA and lupus. What are some recent highlights from this program with respect to RA and lupus? AMP RA/SLE was dedicated to identifying promising therapeutic targets for RA and systemic lupus erythematosus. AMP-funded researchers have applied cutting-edge technologies to study cells from the synovial tissues of the joints of people with RA, and from the kidneys of people with lupus nephritis. In 2014, studying tissues in patients where the disease is active was a novel approach, since most research was conducted in mouse models or human blood samples.
The AMP RA/SLE Network developed a rich dataset that is available to the research community. Investigators are now using the data to facilitate RA and lupus research. For example, using AMP data, NIAMS-supported researchers identified potential biomarkers that could help predict an imminent RA flare. Work from another NIAMS-supported group suggests that targeting the regulatory transcription factor HIF-1, which drives inflammation and tissue damage, might be an effective approach for treating renal injury in lupus.
The data generated are accessible to the scientific community through two NIH websites: the database of Genotypes and Phenotypes (dbGaP) and the Immunology Database and Analysis Portal (IMMPORT).
Given the success of AMP RA/SLE, NIH plans to launch an “AMP 2.0” later in 2021. The AMP Autoimmune and Immune-Mediated Diseases (AMP AIM) program will provide an opportunity to leverage the accomplishments of AMP RA/SLE to new conditions, including psoriatic spectrum diseases and Sjögren’s syndrome.
What are some recent highlights from NIAMS-supported research in skin diseases? NIAMS-supported investigators continue to make significant strides in our understanding of skin biology and disease. For example, researchers recently demonstrated that imiquimod, a drug used to treat precancerous skin lesions, can help mouse ear wounds heal without scarring.
Another team addressed the safety and potential benefit of Staphylococcus hominis A9, a bacterium isolated from healthy human skin, as a topical therapy for atopic dermatitis.
Moving forward, AMP AIM will refine and extend the single-cell analysis of tissues to additional diseases, including psoriasis, setting the stage for the discovery of new therapeutic targets for the disease.
How has the COVID-19 pandemic changed the landscape of research, at least for the short term? This is a once-in-a-century pandemic that none of us were fully prepared for. We understand that it has been particularly challenging for women scientists, scientists with young children, and trainees and junior faculty who are at critically important and vulnerable stages of their careers. There isn’t a lab or clinical setting that hasn’t been negatively impacted in some way.
During the pandemic, the NIH instituted administrative flexibilities to support the grantee community, including extensions in time. In addition, the agency has issued several funding opportunities specific to COVID-19, some of which involve NIAMS participation.
What is NIAMS doing to help early/young investigators as well as female investigators and those from minority groups? Structural racism in biomedical research is a heightened concern. Earlier this year, Dr. Collins established the UNITE initiative to address structural racism and promote racial equity and inclusion at the NIH and within the larger biomedical community that we support. NIAMS is fully committed to this effort. One example is the Diversity Supplement Program, which is designed to attract and encourage eligible individuals from underrepresented populations to research careers.
Early-stage investigators are another top priority. In a tribute to the beloved former NIAMS director, NIH recently established the Stephen I. Katz Early Stage Investigator Research Grant Program. The R01 award provides support for a project unrelated to an early investigator’s area of postdoctoral study. (No preliminary data are allowed.) This award mechanism is a unique opportunity for early-stage investigators to take their research in a completely new direction.
Managing work and family life is an important concern, particularly for female investigators. Many NIH grant awards allow for reimbursement of actual, allowable costs incurred for childcare and parental leave. The NIH is exploring initiatives to promote research continuity and retention of eligible investigators facing major life events, such as pregnancy, childbirth, and adoption, at vulnerable career stages.
Who inspires you most in your work today? I am inspired by the ongoing struggles of our patients, junior investigators, and by the committed staff members on my team.
After many years at the University of California, San Francisco, Lindsey A. Criswell, MD, MPH, DSc, began a new chapter in February 2021 as the director of the National Institute of Arthritis and Musculoskeletal and Skin Disease, part of the National Institutes of Health. NIH Director Francis S. Collins, MD, PhD, selected her for the post.
“Dr. Criswell has rich experience as a clinician, researcher, and administrator,” Dr. Collins said in a prepared statement. “Her ability to oversee the research program of one of the country’s top research-intensive medical schools, and her expertise in autoimmune diseases, including rheumatoid arthritis and lupus, make her well positioned to direct NIAMS.” Dr. Criswell, a rheumatologist, was named a full professor of medicine at UCSF in 2007 and had served as vice chancellor of research at the university since 2017. She has authored more than 250 peer-reviewed scientific papers, and her efforts have contributed to the identification of more than 30 genes linked to autoimmune disorders. In her first media interview, Dr. Criswell opens up about her mentors, operational challenges posed by the COVID-19 pandemic, and highlights many NIAMS research projects underway.
Who inspired you most early in your career as a physician scientist? I have had great opportunities to work with fabulous mentors. Wallace (Wally) Epstein, MD, was my mentor when I was a rheumatology fellow and junior faculty member at UCSF. He was broadly admired for the breadth of his experience as a clinician and a researcher, and he was noteworthy at that time for his strong support for women and students of color. One of the many things I appreciated about him was his diverse range of interests outside of work, which included cello playing and woodworking.
Another mentor was Ephraim (Eph) Engleman, MD, the first academic rheumatologist in California. Eph continued to see patients beyond the age of 100. Perhaps his most important contributions were his efforts towards advocacy for funding for research and education in rheumatology. A prodigy violinist, he too had a broad range of personal interests.
What research into the genetics and epidemiology of human autoimmune disease that you have been a part of has most surprised you, in term of its ultimate clinical impact? Some of my most rewarding and impactful work has focused on the shared genetic basis of autoimmune diseases. We’ve identified dozens of genes that contribute to the risk and outcome of rheumatoid arthritis, lupus, and other autoimmune disorders. These discoveries regarding shared genes and pathways among such a diverse set of conditions have helped to inform optimal therapeutic target and treatment strategies across multiple diseases. For example, exploration of RA genes and pathways has revealed that approved agents for other conditions, such as cancer, may be appropriately repurposed for the treatment of RA. These are critical observations that have the potential to dramatically accelerate progress in developing new therapies for autoimmune diseases, such as RA.
Did you have much interaction with Stephen I. Katz, MD, PhD, your longtime predecessor who passed away unexpectedly in 2018? If so, what do you remember most about him? I regret that I had very little interaction with Steve, but I am well aware of the impact he had on NIAMS, NIH, and the research enterprise overall. He inspired so many people in a personal way, and I am energized by the legacy that he left behind.
What are your goals for the early part of your tenure as the new director of NIAMS? An important goal is getting to know the NIAMS community and expanding my knowledge of the Institute’s musculoskeletal and skin portfolios. I am also conducting outreach to Institute/Center directors and other NIH leadership to increase opportunities for input and advice. In doing this, I am identifying shared research interests, best practices, and potential partners for possible future collaborations. Another important goal is to increase NIAMS’ visibility within and beyond NIH. Ultimately, I want to contribute to the great work of the Institute and improve the lives of people with rheumatic, musculoskeletal, and skin diseases.
How would you characterize your management style? I like to lead with a flat hierarchy and work collectively to address opportunities and challenges. I value team building and tend to tap a variety of perspectives and expertise at all levels to achieve consensus, where possible.
The Accelerating Medicines Partnership (AMP) program was launched in 2014, with projects in three disease areas including the autoimmune disorders RA and lupus. What are some recent highlights from this program with respect to RA and lupus? AMP RA/SLE was dedicated to identifying promising therapeutic targets for RA and systemic lupus erythematosus. AMP-funded researchers have applied cutting-edge technologies to study cells from the synovial tissues of the joints of people with RA, and from the kidneys of people with lupus nephritis. In 2014, studying tissues in patients where the disease is active was a novel approach, since most research was conducted in mouse models or human blood samples.
The AMP RA/SLE Network developed a rich dataset that is available to the research community. Investigators are now using the data to facilitate RA and lupus research. For example, using AMP data, NIAMS-supported researchers identified potential biomarkers that could help predict an imminent RA flare. Work from another NIAMS-supported group suggests that targeting the regulatory transcription factor HIF-1, which drives inflammation and tissue damage, might be an effective approach for treating renal injury in lupus.
The data generated are accessible to the scientific community through two NIH websites: the database of Genotypes and Phenotypes (dbGaP) and the Immunology Database and Analysis Portal (IMMPORT).
Given the success of AMP RA/SLE, NIH plans to launch an “AMP 2.0” later in 2021. The AMP Autoimmune and Immune-Mediated Diseases (AMP AIM) program will provide an opportunity to leverage the accomplishments of AMP RA/SLE to new conditions, including psoriatic spectrum diseases and Sjögren’s syndrome.
What are some recent highlights from NIAMS-supported research in skin diseases? NIAMS-supported investigators continue to make significant strides in our understanding of skin biology and disease. For example, researchers recently demonstrated that imiquimod, a drug used to treat precancerous skin lesions, can help mouse ear wounds heal without scarring.
Another team addressed the safety and potential benefit of Staphylococcus hominis A9, a bacterium isolated from healthy human skin, as a topical therapy for atopic dermatitis.
Moving forward, AMP AIM will refine and extend the single-cell analysis of tissues to additional diseases, including psoriasis, setting the stage for the discovery of new therapeutic targets for the disease.
How has the COVID-19 pandemic changed the landscape of research, at least for the short term? This is a once-in-a-century pandemic that none of us were fully prepared for. We understand that it has been particularly challenging for women scientists, scientists with young children, and trainees and junior faculty who are at critically important and vulnerable stages of their careers. There isn’t a lab or clinical setting that hasn’t been negatively impacted in some way.
During the pandemic, the NIH instituted administrative flexibilities to support the grantee community, including extensions in time. In addition, the agency has issued several funding opportunities specific to COVID-19, some of which involve NIAMS participation.
What is NIAMS doing to help early/young investigators as well as female investigators and those from minority groups? Structural racism in biomedical research is a heightened concern. Earlier this year, Dr. Collins established the UNITE initiative to address structural racism and promote racial equity and inclusion at the NIH and within the larger biomedical community that we support. NIAMS is fully committed to this effort. One example is the Diversity Supplement Program, which is designed to attract and encourage eligible individuals from underrepresented populations to research careers.
Early-stage investigators are another top priority. In a tribute to the beloved former NIAMS director, NIH recently established the Stephen I. Katz Early Stage Investigator Research Grant Program. The R01 award provides support for a project unrelated to an early investigator’s area of postdoctoral study. (No preliminary data are allowed.) This award mechanism is a unique opportunity for early-stage investigators to take their research in a completely new direction.
Managing work and family life is an important concern, particularly for female investigators. Many NIH grant awards allow for reimbursement of actual, allowable costs incurred for childcare and parental leave. The NIH is exploring initiatives to promote research continuity and retention of eligible investigators facing major life events, such as pregnancy, childbirth, and adoption, at vulnerable career stages.
Who inspires you most in your work today? I am inspired by the ongoing struggles of our patients, junior investigators, and by the committed staff members on my team.
New data illustrate pandemic pivot to telehealth by patients, physicians
Telehealth use, although much higher than before the COVID-19 pandemic, accounted for less than 20% of weekly outpatient visits 6 months into the pandemic, according to a new report from the American Medical Association. Ten percent of weekly visits were conducted via videoconferencing, and 8.1% of visits were conducted using the telephone.
Those figures may overstate the true level of telehealth use in fall 2020. A study by the Commonwealth Fund, Harvard University, Boston, and Phreesia found that in December of that year, only 8% of outpatient visits involved the use of telemedicine – and that was up from 6% in October. In contrast to the AMA results, which came from its 2020 benchmark survey of physicians, the Commonwealth Fund study used data from practice management systems and an online patient registration platform, as well as electronic health record data.
A more recent survey of hospital executives found that as of September 2021, hospital telehealth visits had leveled off at 10% to 20% of appointments. Similarly, a McKinsey survey in July showed that telehealth encounters made up 13% to 17% of evaluation and management visits across all specialties.
Big jump during pandemic
The AMA report offers a wealth of data on how physicians use telehealth and the differences between specialties in this area.
The report found that 70.3% of physicians worked in practices that used videoconferencing to provide patient visits in September 2020, compared to 14.3% of physicians in September 2018. Sixty-seven percent of physicians worked in practices that used telephone visits (the comparable figure for 2018 was unavailable).
Overall, 79% of physicians worked in a practice that used telehealth, compared to 25% in 2018.
Not every doctor in practices that utilized telehealth conducted virtual visits. In contrast to the 70.3% of doctors who were in practices that had video visits, only 59.1% of the respondents had personally conducted a videoconferencing visit in the previous week. The average numbers of weekly video and telephone visits per physician were 9.9 and 7.6, respectively, including those who did none.
There were big differences in virtual visit use among specialties as well. Eighty-five percent of psychiatrists were in practices that provided online appointments, according to the AMA survey, and three-quarters of primary care physicians said their practices offered telehealth appointments. Pediatricians were much less likely than family practice/general practice physicians (FPs/GPs) or general internists to do so.
The practices of many medical specialists were also highly likely to provide telehealth. Over 75% of practices in cardiology, endocrinology/diabetes, gastroenterology, nephrology, and neurology offered telehealth visits. About 88% of hematologists/oncologists offered video visits. Far fewer surgeons reported that their practice used virtual visits; the exceptions were urologists and dermatologists, 87% of whose practices used telehealth.
How telehealth was used
Across all specialties, 58% of physicians said clinicians in their practices used it to diagnose or treat patients; 59.2%, to manage patients with chronic disease; 50.4%, to provide acute care; and 34.3%, to provide preventive care.
Seventy-two percent of FP/GP and pediatric practices used telehealth to diagnose or treat patients. Just 64.9% of internists said their practices did so, and only 61.9% of them said their practices provided acute care via telehealth, versus 70% of FPs/GPs and pediatricians.
Among medical specialties, endocrinologists/diabetes physicians were those most likely to report the practice-level use of telehealth to diagnose or treat patients (71.9%), manage patients with chronic disease (92.1%), and provide preventive care (52.6%).
Significantly, 33% of medical specialists said their practices used remote patient monitoring. This finding was driven by high rates of use among cardiology practices (63.3%) and endocrinology practices (41.6%). Overall, the practice-level use of remote patient monitoring rose from 10.4% of practices in 2018 to 19.9% in 2020.
Virtual consults with peers
Some practices used telehealth to enable physicians to consult with colleagues. Twelve percent of respondents said their practices used telehealth to seek a second opinion from a health care professional in 2020, compared to 6.9% in 2018. Formal consultations via telehealth were also increasingly common: 17.2% of doctors said their practices did this in 2020, compared to 11.3% in 2018.
Also of note, 22.4% of physicians said their practices used telehealth for after-hours care or night calls in 2020, versus 9.9% in 2018.
The AMA report credited telehealth and expanded coverage and payment rules for enabling physician practices to keep their revenue streams positive and their practices open. However, the Commonwealth Fund study found “a substantial cumulative reduction in visits across all specialties over the course of the pandemic in 2020.” These ranged from a drop of 27% in pediatric visits to a decline of 8% in rheumatology visits during the period from March to December 2020.
A version of this article first appeared on Medscape.com.
Telehealth use, although much higher than before the COVID-19 pandemic, accounted for less than 20% of weekly outpatient visits 6 months into the pandemic, according to a new report from the American Medical Association. Ten percent of weekly visits were conducted via videoconferencing, and 8.1% of visits were conducted using the telephone.
Those figures may overstate the true level of telehealth use in fall 2020. A study by the Commonwealth Fund, Harvard University, Boston, and Phreesia found that in December of that year, only 8% of outpatient visits involved the use of telemedicine – and that was up from 6% in October. In contrast to the AMA results, which came from its 2020 benchmark survey of physicians, the Commonwealth Fund study used data from practice management systems and an online patient registration platform, as well as electronic health record data.
A more recent survey of hospital executives found that as of September 2021, hospital telehealth visits had leveled off at 10% to 20% of appointments. Similarly, a McKinsey survey in July showed that telehealth encounters made up 13% to 17% of evaluation and management visits across all specialties.
Big jump during pandemic
The AMA report offers a wealth of data on how physicians use telehealth and the differences between specialties in this area.
The report found that 70.3% of physicians worked in practices that used videoconferencing to provide patient visits in September 2020, compared to 14.3% of physicians in September 2018. Sixty-seven percent of physicians worked in practices that used telephone visits (the comparable figure for 2018 was unavailable).
Overall, 79% of physicians worked in a practice that used telehealth, compared to 25% in 2018.
Not every doctor in practices that utilized telehealth conducted virtual visits. In contrast to the 70.3% of doctors who were in practices that had video visits, only 59.1% of the respondents had personally conducted a videoconferencing visit in the previous week. The average numbers of weekly video and telephone visits per physician were 9.9 and 7.6, respectively, including those who did none.
There were big differences in virtual visit use among specialties as well. Eighty-five percent of psychiatrists were in practices that provided online appointments, according to the AMA survey, and three-quarters of primary care physicians said their practices offered telehealth appointments. Pediatricians were much less likely than family practice/general practice physicians (FPs/GPs) or general internists to do so.
The practices of many medical specialists were also highly likely to provide telehealth. Over 75% of practices in cardiology, endocrinology/diabetes, gastroenterology, nephrology, and neurology offered telehealth visits. About 88% of hematologists/oncologists offered video visits. Far fewer surgeons reported that their practice used virtual visits; the exceptions were urologists and dermatologists, 87% of whose practices used telehealth.
How telehealth was used
Across all specialties, 58% of physicians said clinicians in their practices used it to diagnose or treat patients; 59.2%, to manage patients with chronic disease; 50.4%, to provide acute care; and 34.3%, to provide preventive care.
Seventy-two percent of FP/GP and pediatric practices used telehealth to diagnose or treat patients. Just 64.9% of internists said their practices did so, and only 61.9% of them said their practices provided acute care via telehealth, versus 70% of FPs/GPs and pediatricians.
Among medical specialties, endocrinologists/diabetes physicians were those most likely to report the practice-level use of telehealth to diagnose or treat patients (71.9%), manage patients with chronic disease (92.1%), and provide preventive care (52.6%).
Significantly, 33% of medical specialists said their practices used remote patient monitoring. This finding was driven by high rates of use among cardiology practices (63.3%) and endocrinology practices (41.6%). Overall, the practice-level use of remote patient monitoring rose from 10.4% of practices in 2018 to 19.9% in 2020.
Virtual consults with peers
Some practices used telehealth to enable physicians to consult with colleagues. Twelve percent of respondents said their practices used telehealth to seek a second opinion from a health care professional in 2020, compared to 6.9% in 2018. Formal consultations via telehealth were also increasingly common: 17.2% of doctors said their practices did this in 2020, compared to 11.3% in 2018.
Also of note, 22.4% of physicians said their practices used telehealth for after-hours care or night calls in 2020, versus 9.9% in 2018.
The AMA report credited telehealth and expanded coverage and payment rules for enabling physician practices to keep their revenue streams positive and their practices open. However, the Commonwealth Fund study found “a substantial cumulative reduction in visits across all specialties over the course of the pandemic in 2020.” These ranged from a drop of 27% in pediatric visits to a decline of 8% in rheumatology visits during the period from March to December 2020.
A version of this article first appeared on Medscape.com.
Telehealth use, although much higher than before the COVID-19 pandemic, accounted for less than 20% of weekly outpatient visits 6 months into the pandemic, according to a new report from the American Medical Association. Ten percent of weekly visits were conducted via videoconferencing, and 8.1% of visits were conducted using the telephone.
Those figures may overstate the true level of telehealth use in fall 2020. A study by the Commonwealth Fund, Harvard University, Boston, and Phreesia found that in December of that year, only 8% of outpatient visits involved the use of telemedicine – and that was up from 6% in October. In contrast to the AMA results, which came from its 2020 benchmark survey of physicians, the Commonwealth Fund study used data from practice management systems and an online patient registration platform, as well as electronic health record data.
A more recent survey of hospital executives found that as of September 2021, hospital telehealth visits had leveled off at 10% to 20% of appointments. Similarly, a McKinsey survey in July showed that telehealth encounters made up 13% to 17% of evaluation and management visits across all specialties.
Big jump during pandemic
The AMA report offers a wealth of data on how physicians use telehealth and the differences between specialties in this area.
The report found that 70.3% of physicians worked in practices that used videoconferencing to provide patient visits in September 2020, compared to 14.3% of physicians in September 2018. Sixty-seven percent of physicians worked in practices that used telephone visits (the comparable figure for 2018 was unavailable).
Overall, 79% of physicians worked in a practice that used telehealth, compared to 25% in 2018.
Not every doctor in practices that utilized telehealth conducted virtual visits. In contrast to the 70.3% of doctors who were in practices that had video visits, only 59.1% of the respondents had personally conducted a videoconferencing visit in the previous week. The average numbers of weekly video and telephone visits per physician were 9.9 and 7.6, respectively, including those who did none.
There were big differences in virtual visit use among specialties as well. Eighty-five percent of psychiatrists were in practices that provided online appointments, according to the AMA survey, and three-quarters of primary care physicians said their practices offered telehealth appointments. Pediatricians were much less likely than family practice/general practice physicians (FPs/GPs) or general internists to do so.
The practices of many medical specialists were also highly likely to provide telehealth. Over 75% of practices in cardiology, endocrinology/diabetes, gastroenterology, nephrology, and neurology offered telehealth visits. About 88% of hematologists/oncologists offered video visits. Far fewer surgeons reported that their practice used virtual visits; the exceptions were urologists and dermatologists, 87% of whose practices used telehealth.
How telehealth was used
Across all specialties, 58% of physicians said clinicians in their practices used it to diagnose or treat patients; 59.2%, to manage patients with chronic disease; 50.4%, to provide acute care; and 34.3%, to provide preventive care.
Seventy-two percent of FP/GP and pediatric practices used telehealth to diagnose or treat patients. Just 64.9% of internists said their practices did so, and only 61.9% of them said their practices provided acute care via telehealth, versus 70% of FPs/GPs and pediatricians.
Among medical specialties, endocrinologists/diabetes physicians were those most likely to report the practice-level use of telehealth to diagnose or treat patients (71.9%), manage patients with chronic disease (92.1%), and provide preventive care (52.6%).
Significantly, 33% of medical specialists said their practices used remote patient monitoring. This finding was driven by high rates of use among cardiology practices (63.3%) and endocrinology practices (41.6%). Overall, the practice-level use of remote patient monitoring rose from 10.4% of practices in 2018 to 19.9% in 2020.
Virtual consults with peers
Some practices used telehealth to enable physicians to consult with colleagues. Twelve percent of respondents said their practices used telehealth to seek a second opinion from a health care professional in 2020, compared to 6.9% in 2018. Formal consultations via telehealth were also increasingly common: 17.2% of doctors said their practices did this in 2020, compared to 11.3% in 2018.
Also of note, 22.4% of physicians said their practices used telehealth for after-hours care or night calls in 2020, versus 9.9% in 2018.
The AMA report credited telehealth and expanded coverage and payment rules for enabling physician practices to keep their revenue streams positive and their practices open. However, the Commonwealth Fund study found “a substantial cumulative reduction in visits across all specialties over the course of the pandemic in 2020.” These ranged from a drop of 27% in pediatric visits to a decline of 8% in rheumatology visits during the period from March to December 2020.
A version of this article first appeared on Medscape.com.