Califf plans work on opioids, accelerated approvals on return to FDA

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Robert M. Califf, MD, plans to take a close look at federal policies on opioid prescriptions in his expected second turn as the top U.S. regulator of medical products, as well as keep closer tabs on the performance of drugs cleared with accelerated approvals.

Catherine Hackett/Frontline Medical News
Dr. Robert M. Califf

Dr. Califf on Tuesday fielded questions at a Senate hearing about his nomination by President Joe Biden to serve as administrator of the U.S. Food and Drug Administration, a role in which he served in the Obama administration. He also spoke about the need to bolster the nation’s ability to maintain an adequate supply of key medical products, including drugs.

Members of the Senate Health, Education, Labor and Pensions Committee, which is handling Dr. Califf’s nomination, were largely cordial and supportive during the hearing. Sen. Patty Murray (D-Wash.), the committee chair, and the panel’s top Republican, Sen. Richard Burr of North Carolina, addressed Dr. Califf during the hearing as if he would soon serve again as the FDA’s leader. Both were among the senators who voted 89-4 to confirm Dr. Califf in a February 2016 vote.

Dr. Califf “was previously confirmed to lead FDA in an overwhelming bipartisan vote, and I look forward to working with him again to ensure FDA continues to protect families across the country, uphold the gold standard of safety and effectiveness, and put science and data first,” Sen. Murray said.

Less enthusiastic about Dr. Califf was Sen. Bernie Sanders (I-VT), who was among the seven senators who did not vote on Dr. Califf’s nomination in 2016.

Sen. Sanders objected in 2016 to Dr. Califf’s ties to the pharmaceutical industry, and he did so again Tuesday. A noted leader in conducting clinical trials, Dr. Califf has worked with many drugmakers. But at the hearing, Dr. Califf said he concurs with Sen. Sanders on an idea strongly opposed by the pharmaceutical industry.

In response to Sen. Sanders’ question, Dr. Califf said he already is “on record as being in favor of Medicare negotiating with the industry on prices.”

The FDA would not take direct part in negotiations, as this work would be handled by the Centers for Medicare & Medicaid Services. Democrats want to give Medicare some negotiating authority through their sweeping Build Back Better Act.

People in the United States are dismayed over both the cost of prescription drugs and the widespread distribution of prescription painkillers that helped fuel the current opioid epidemic, Sen. Sanders told Dr. Califf. Many people will be concerned about an FDA commissioner who has benefited from close ties to the industry, Sen. Sanders said.

“How are they going to believe that you’re going to be an independent and strong voice against this enormously powerful, special interest?” Sen. Sanders asked.

“I’m totally with you on the concept that the price of pharmaceuticals is way too high in this country,” Dr. Califf said in reply.

Dr. Califf was paid $2.7 million in salary and bonus by Verily Life Sciences, the biomedical research organization operated by Alphabet, parent company of Google, according to his federal financial disclosure. He also reported holding board positions with pharmaceutical companies AmyriAD and Centessa Pharmaceuticals.

Bloomberg Government reported that Dr. Califf has ties to about 16 other research organizations and biotech companies. Bloomberg Government also said that, in his earlier FDA service, Dr. Califf kept a whiteboard in his office that listed all the activities and projects that required his recusal, citing as a source Howard Sklamberg, who was a deputy commissioner under Dr. Califf.

“He was very, very, very careful,” Mr. Sklamberg, who’s now an attorney at Arnold & Porter LLP, told Bloomberg Government.
 

 

 

‘Work to do’ on opioids

Senators looped back repeatedly to the topic of opioids during Dr. Califf’s hearing, reflecting deep concerns about the FDA’s efforts to warn of the risks of prescription painkillers.

There were an estimated 100,306 drug overdose deaths in the United States in the 12 months ending in April, an increase of 28.5% from the 78,056 deaths during the same period the year before, according to the Centers for Disease Control and Prevention.

Dr. Califf said he plans to focus on what information the FDA conveys to the public about the risks of prescription painkillers, including a look at what the labels for these products say.

“I am committed to do a comprehensive review of the status of opioids, early in my tenure,” Dr. Califf said.

Dr. Califf indicated that physicians are still too quick to provide excess doses of these medicines, despite years of efforts to restrain their use. He said he knows relatives who were given 30-day prescriptions for opioids after minor surgery.

“So I know we have work to do,” Dr. Califf said.

Concerns about the FDA’s previous work in managing opioids has led to protests from a few Democratic senators about the prospect of President Biden nominating the acting FDA commissioner, Janet Woodcock, MD, for the permanent post.

At the hearing, Sen. Ben Ray Luján (D-NM) raised the case of the FDA’s approval of the powerful Zohydro painkiller. The agency approved that drug despite an 11-2 vote against it by the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee.



Sen. Luján asked Dr. Califf what he would do if an FDA advisory committee voted “overwhelmingly” against recommending approval of a medicine, as happened in the Zohydro case.

While not mentioned by Sen. Luján in this exchange during the hearing with Dr. Califf, the FDA staff’s rejection of recommendations of advisory committees has been a growing concern among researchers.

The agency last year approved aducanumab (Aduhelm, Biogen), a drug for Alzheimer’s disease, dismissing the advice of its Peripheral and Central Nervous System Drugs Advisory Committee. That decision triggered the resignation of several members of the panel. The FDA staff also earlier rejected the conclusion the majority of members of the same advisory committee offered in 2016 on eteplirsen (Exondys 51, Sarepta), a drug for Duchenne muscular dystrophy.

Dr. Califf told Sen. Luján he had done recent research into how often the FDA staff does not concur with the recommendations of an advisory committee. He said the FDA takes a different course of action in about 25% of cases. In about three-quarters of those cases, the FDA staff opts for a “more stringent” approach regarding allowing the public access to the drug, as opposed to a more generous one as seen in the Zohydro, Aduhelm, and Exondys 51 cases.

Still, Dr. Califf said that when there’s an 11-2 advisory committee vote against recommendation of a product, “the leaders at FDA really need to take a close look” at what’s happening.

Question on accelerated approvals

The FDA’s approval of aducanumab drew attention to a debate already underway about conditional clearances known as accelerated approvals.

The FDA has used this path since the 1990s to speed access to drugs for serious conditions. The trade-off for early access is that the agency sometimes makes the wrong call based on initial findings, and clears a medicine later found not to benefit patients as expected.

The FDA’s cancer division is in the midst of public efforts to address cases where drugmakers have not been able to deliver studies that support accelerated approvals of their oncology drugs. In addition, the Office of Inspector General of the U.S. Department of Health & Human Services announced in August that it is reviewing the FDA’s handling of the accelerated approval process.

At Tuesday’s hearing, Sen. Burr grilled Dr. Califf about how he would respond to calls to change how the FDA handles the accelerated-approval process.

“Can you commit to me and to patients who may rely on cutting-edge treatments that you will not support efforts to narrow this pathway or raise the bar for drugs to be approved under those pathways?” Burr asked Califf.

Dr. Califf responded by saying he was “a fan of accelerated approval – for the right conditions.”

Earlier, in his opening statement, Dr. Califf had said his mother benefited directly from the accelerated approval of new drugs for multiple myeloma. Dr. Califf told Sen. Burr that he had spent “countless hours with patient groups” and understands the need to speed the approval of medicines for serious diseases.

But the FDA also has to make sure it holds up its end of the bargain struck with accelerated approvals. This involves checking on how these medicines work once they are marketed.

“We’re accepting that there’s more uncertainty,” Dr. Califf said. “That means we’ve got to have a better system to evaluate these products as they’re used on the market. And I think there are ways that we can do that now. Technology is making this possible in ways that it just was not possible before.”
 

Worries about the medical supply chain

Sen. Susan Collins (R-Maine) asked Dr. Califf about the vulnerability of the U.S. medical system to disruptions of the supply chain. She raised concerns about China’s dominance in antibiotic manufacturing as an example. She asked if Congress could do more to encourage domestic manufacturing of medical supplies, such as by offering tax incentives.

Dr. Califf told Sen. Collins he shared her concern about the U.S. manufacturing of ingredients used in both branded and generic drugs. He said he recently has served on a committee of the National Academy of Medicine that is examining supply chain issues.

This committee will soon release a report with specific recommendations, Dr. Califf said.

“We don’t have enough competitive entities in what’s become sort of a commodity business” of drug manufacturing, Dr. Califf said. “So we need a number of steps to make the system more resilient.”

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

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Robert M. Califf, MD, plans to take a close look at federal policies on opioid prescriptions in his expected second turn as the top U.S. regulator of medical products, as well as keep closer tabs on the performance of drugs cleared with accelerated approvals.

Catherine Hackett/Frontline Medical News
Dr. Robert M. Califf

Dr. Califf on Tuesday fielded questions at a Senate hearing about his nomination by President Joe Biden to serve as administrator of the U.S. Food and Drug Administration, a role in which he served in the Obama administration. He also spoke about the need to bolster the nation’s ability to maintain an adequate supply of key medical products, including drugs.

Members of the Senate Health, Education, Labor and Pensions Committee, which is handling Dr. Califf’s nomination, were largely cordial and supportive during the hearing. Sen. Patty Murray (D-Wash.), the committee chair, and the panel’s top Republican, Sen. Richard Burr of North Carolina, addressed Dr. Califf during the hearing as if he would soon serve again as the FDA’s leader. Both were among the senators who voted 89-4 to confirm Dr. Califf in a February 2016 vote.

Dr. Califf “was previously confirmed to lead FDA in an overwhelming bipartisan vote, and I look forward to working with him again to ensure FDA continues to protect families across the country, uphold the gold standard of safety and effectiveness, and put science and data first,” Sen. Murray said.

Less enthusiastic about Dr. Califf was Sen. Bernie Sanders (I-VT), who was among the seven senators who did not vote on Dr. Califf’s nomination in 2016.

Sen. Sanders objected in 2016 to Dr. Califf’s ties to the pharmaceutical industry, and he did so again Tuesday. A noted leader in conducting clinical trials, Dr. Califf has worked with many drugmakers. But at the hearing, Dr. Califf said he concurs with Sen. Sanders on an idea strongly opposed by the pharmaceutical industry.

In response to Sen. Sanders’ question, Dr. Califf said he already is “on record as being in favor of Medicare negotiating with the industry on prices.”

The FDA would not take direct part in negotiations, as this work would be handled by the Centers for Medicare & Medicaid Services. Democrats want to give Medicare some negotiating authority through their sweeping Build Back Better Act.

People in the United States are dismayed over both the cost of prescription drugs and the widespread distribution of prescription painkillers that helped fuel the current opioid epidemic, Sen. Sanders told Dr. Califf. Many people will be concerned about an FDA commissioner who has benefited from close ties to the industry, Sen. Sanders said.

“How are they going to believe that you’re going to be an independent and strong voice against this enormously powerful, special interest?” Sen. Sanders asked.

“I’m totally with you on the concept that the price of pharmaceuticals is way too high in this country,” Dr. Califf said in reply.

Dr. Califf was paid $2.7 million in salary and bonus by Verily Life Sciences, the biomedical research organization operated by Alphabet, parent company of Google, according to his federal financial disclosure. He also reported holding board positions with pharmaceutical companies AmyriAD and Centessa Pharmaceuticals.

Bloomberg Government reported that Dr. Califf has ties to about 16 other research organizations and biotech companies. Bloomberg Government also said that, in his earlier FDA service, Dr. Califf kept a whiteboard in his office that listed all the activities and projects that required his recusal, citing as a source Howard Sklamberg, who was a deputy commissioner under Dr. Califf.

“He was very, very, very careful,” Mr. Sklamberg, who’s now an attorney at Arnold & Porter LLP, told Bloomberg Government.
 

 

 

‘Work to do’ on opioids

Senators looped back repeatedly to the topic of opioids during Dr. Califf’s hearing, reflecting deep concerns about the FDA’s efforts to warn of the risks of prescription painkillers.

There were an estimated 100,306 drug overdose deaths in the United States in the 12 months ending in April, an increase of 28.5% from the 78,056 deaths during the same period the year before, according to the Centers for Disease Control and Prevention.

Dr. Califf said he plans to focus on what information the FDA conveys to the public about the risks of prescription painkillers, including a look at what the labels for these products say.

“I am committed to do a comprehensive review of the status of opioids, early in my tenure,” Dr. Califf said.

Dr. Califf indicated that physicians are still too quick to provide excess doses of these medicines, despite years of efforts to restrain their use. He said he knows relatives who were given 30-day prescriptions for opioids after minor surgery.

“So I know we have work to do,” Dr. Califf said.

Concerns about the FDA’s previous work in managing opioids has led to protests from a few Democratic senators about the prospect of President Biden nominating the acting FDA commissioner, Janet Woodcock, MD, for the permanent post.

At the hearing, Sen. Ben Ray Luján (D-NM) raised the case of the FDA’s approval of the powerful Zohydro painkiller. The agency approved that drug despite an 11-2 vote against it by the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee.



Sen. Luján asked Dr. Califf what he would do if an FDA advisory committee voted “overwhelmingly” against recommending approval of a medicine, as happened in the Zohydro case.

While not mentioned by Sen. Luján in this exchange during the hearing with Dr. Califf, the FDA staff’s rejection of recommendations of advisory committees has been a growing concern among researchers.

The agency last year approved aducanumab (Aduhelm, Biogen), a drug for Alzheimer’s disease, dismissing the advice of its Peripheral and Central Nervous System Drugs Advisory Committee. That decision triggered the resignation of several members of the panel. The FDA staff also earlier rejected the conclusion the majority of members of the same advisory committee offered in 2016 on eteplirsen (Exondys 51, Sarepta), a drug for Duchenne muscular dystrophy.

Dr. Califf told Sen. Luján he had done recent research into how often the FDA staff does not concur with the recommendations of an advisory committee. He said the FDA takes a different course of action in about 25% of cases. In about three-quarters of those cases, the FDA staff opts for a “more stringent” approach regarding allowing the public access to the drug, as opposed to a more generous one as seen in the Zohydro, Aduhelm, and Exondys 51 cases.

Still, Dr. Califf said that when there’s an 11-2 advisory committee vote against recommendation of a product, “the leaders at FDA really need to take a close look” at what’s happening.

Question on accelerated approvals

The FDA’s approval of aducanumab drew attention to a debate already underway about conditional clearances known as accelerated approvals.

The FDA has used this path since the 1990s to speed access to drugs for serious conditions. The trade-off for early access is that the agency sometimes makes the wrong call based on initial findings, and clears a medicine later found not to benefit patients as expected.

The FDA’s cancer division is in the midst of public efforts to address cases where drugmakers have not been able to deliver studies that support accelerated approvals of their oncology drugs. In addition, the Office of Inspector General of the U.S. Department of Health & Human Services announced in August that it is reviewing the FDA’s handling of the accelerated approval process.

At Tuesday’s hearing, Sen. Burr grilled Dr. Califf about how he would respond to calls to change how the FDA handles the accelerated-approval process.

“Can you commit to me and to patients who may rely on cutting-edge treatments that you will not support efforts to narrow this pathway or raise the bar for drugs to be approved under those pathways?” Burr asked Califf.

Dr. Califf responded by saying he was “a fan of accelerated approval – for the right conditions.”

Earlier, in his opening statement, Dr. Califf had said his mother benefited directly from the accelerated approval of new drugs for multiple myeloma. Dr. Califf told Sen. Burr that he had spent “countless hours with patient groups” and understands the need to speed the approval of medicines for serious diseases.

But the FDA also has to make sure it holds up its end of the bargain struck with accelerated approvals. This involves checking on how these medicines work once they are marketed.

“We’re accepting that there’s more uncertainty,” Dr. Califf said. “That means we’ve got to have a better system to evaluate these products as they’re used on the market. And I think there are ways that we can do that now. Technology is making this possible in ways that it just was not possible before.”
 

Worries about the medical supply chain

Sen. Susan Collins (R-Maine) asked Dr. Califf about the vulnerability of the U.S. medical system to disruptions of the supply chain. She raised concerns about China’s dominance in antibiotic manufacturing as an example. She asked if Congress could do more to encourage domestic manufacturing of medical supplies, such as by offering tax incentives.

Dr. Califf told Sen. Collins he shared her concern about the U.S. manufacturing of ingredients used in both branded and generic drugs. He said he recently has served on a committee of the National Academy of Medicine that is examining supply chain issues.

This committee will soon release a report with specific recommendations, Dr. Califf said.

“We don’t have enough competitive entities in what’s become sort of a commodity business” of drug manufacturing, Dr. Califf said. “So we need a number of steps to make the system more resilient.”

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

Robert M. Califf, MD, plans to take a close look at federal policies on opioid prescriptions in his expected second turn as the top U.S. regulator of medical products, as well as keep closer tabs on the performance of drugs cleared with accelerated approvals.

Catherine Hackett/Frontline Medical News
Dr. Robert M. Califf

Dr. Califf on Tuesday fielded questions at a Senate hearing about his nomination by President Joe Biden to serve as administrator of the U.S. Food and Drug Administration, a role in which he served in the Obama administration. He also spoke about the need to bolster the nation’s ability to maintain an adequate supply of key medical products, including drugs.

Members of the Senate Health, Education, Labor and Pensions Committee, which is handling Dr. Califf’s nomination, were largely cordial and supportive during the hearing. Sen. Patty Murray (D-Wash.), the committee chair, and the panel’s top Republican, Sen. Richard Burr of North Carolina, addressed Dr. Califf during the hearing as if he would soon serve again as the FDA’s leader. Both were among the senators who voted 89-4 to confirm Dr. Califf in a February 2016 vote.

Dr. Califf “was previously confirmed to lead FDA in an overwhelming bipartisan vote, and I look forward to working with him again to ensure FDA continues to protect families across the country, uphold the gold standard of safety and effectiveness, and put science and data first,” Sen. Murray said.

Less enthusiastic about Dr. Califf was Sen. Bernie Sanders (I-VT), who was among the seven senators who did not vote on Dr. Califf’s nomination in 2016.

Sen. Sanders objected in 2016 to Dr. Califf’s ties to the pharmaceutical industry, and he did so again Tuesday. A noted leader in conducting clinical trials, Dr. Califf has worked with many drugmakers. But at the hearing, Dr. Califf said he concurs with Sen. Sanders on an idea strongly opposed by the pharmaceutical industry.

In response to Sen. Sanders’ question, Dr. Califf said he already is “on record as being in favor of Medicare negotiating with the industry on prices.”

The FDA would not take direct part in negotiations, as this work would be handled by the Centers for Medicare & Medicaid Services. Democrats want to give Medicare some negotiating authority through their sweeping Build Back Better Act.

People in the United States are dismayed over both the cost of prescription drugs and the widespread distribution of prescription painkillers that helped fuel the current opioid epidemic, Sen. Sanders told Dr. Califf. Many people will be concerned about an FDA commissioner who has benefited from close ties to the industry, Sen. Sanders said.

“How are they going to believe that you’re going to be an independent and strong voice against this enormously powerful, special interest?” Sen. Sanders asked.

“I’m totally with you on the concept that the price of pharmaceuticals is way too high in this country,” Dr. Califf said in reply.

Dr. Califf was paid $2.7 million in salary and bonus by Verily Life Sciences, the biomedical research organization operated by Alphabet, parent company of Google, according to his federal financial disclosure. He also reported holding board positions with pharmaceutical companies AmyriAD and Centessa Pharmaceuticals.

Bloomberg Government reported that Dr. Califf has ties to about 16 other research organizations and biotech companies. Bloomberg Government also said that, in his earlier FDA service, Dr. Califf kept a whiteboard in his office that listed all the activities and projects that required his recusal, citing as a source Howard Sklamberg, who was a deputy commissioner under Dr. Califf.

“He was very, very, very careful,” Mr. Sklamberg, who’s now an attorney at Arnold & Porter LLP, told Bloomberg Government.
 

 

 

‘Work to do’ on opioids

Senators looped back repeatedly to the topic of opioids during Dr. Califf’s hearing, reflecting deep concerns about the FDA’s efforts to warn of the risks of prescription painkillers.

There were an estimated 100,306 drug overdose deaths in the United States in the 12 months ending in April, an increase of 28.5% from the 78,056 deaths during the same period the year before, according to the Centers for Disease Control and Prevention.

Dr. Califf said he plans to focus on what information the FDA conveys to the public about the risks of prescription painkillers, including a look at what the labels for these products say.

“I am committed to do a comprehensive review of the status of opioids, early in my tenure,” Dr. Califf said.

Dr. Califf indicated that physicians are still too quick to provide excess doses of these medicines, despite years of efforts to restrain their use. He said he knows relatives who were given 30-day prescriptions for opioids after minor surgery.

“So I know we have work to do,” Dr. Califf said.

Concerns about the FDA’s previous work in managing opioids has led to protests from a few Democratic senators about the prospect of President Biden nominating the acting FDA commissioner, Janet Woodcock, MD, for the permanent post.

At the hearing, Sen. Ben Ray Luján (D-NM) raised the case of the FDA’s approval of the powerful Zohydro painkiller. The agency approved that drug despite an 11-2 vote against it by the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee.



Sen. Luján asked Dr. Califf what he would do if an FDA advisory committee voted “overwhelmingly” against recommending approval of a medicine, as happened in the Zohydro case.

While not mentioned by Sen. Luján in this exchange during the hearing with Dr. Califf, the FDA staff’s rejection of recommendations of advisory committees has been a growing concern among researchers.

The agency last year approved aducanumab (Aduhelm, Biogen), a drug for Alzheimer’s disease, dismissing the advice of its Peripheral and Central Nervous System Drugs Advisory Committee. That decision triggered the resignation of several members of the panel. The FDA staff also earlier rejected the conclusion the majority of members of the same advisory committee offered in 2016 on eteplirsen (Exondys 51, Sarepta), a drug for Duchenne muscular dystrophy.

Dr. Califf told Sen. Luján he had done recent research into how often the FDA staff does not concur with the recommendations of an advisory committee. He said the FDA takes a different course of action in about 25% of cases. In about three-quarters of those cases, the FDA staff opts for a “more stringent” approach regarding allowing the public access to the drug, as opposed to a more generous one as seen in the Zohydro, Aduhelm, and Exondys 51 cases.

Still, Dr. Califf said that when there’s an 11-2 advisory committee vote against recommendation of a product, “the leaders at FDA really need to take a close look” at what’s happening.

Question on accelerated approvals

The FDA’s approval of aducanumab drew attention to a debate already underway about conditional clearances known as accelerated approvals.

The FDA has used this path since the 1990s to speed access to drugs for serious conditions. The trade-off for early access is that the agency sometimes makes the wrong call based on initial findings, and clears a medicine later found not to benefit patients as expected.

The FDA’s cancer division is in the midst of public efforts to address cases where drugmakers have not been able to deliver studies that support accelerated approvals of their oncology drugs. In addition, the Office of Inspector General of the U.S. Department of Health & Human Services announced in August that it is reviewing the FDA’s handling of the accelerated approval process.

At Tuesday’s hearing, Sen. Burr grilled Dr. Califf about how he would respond to calls to change how the FDA handles the accelerated-approval process.

“Can you commit to me and to patients who may rely on cutting-edge treatments that you will not support efforts to narrow this pathway or raise the bar for drugs to be approved under those pathways?” Burr asked Califf.

Dr. Califf responded by saying he was “a fan of accelerated approval – for the right conditions.”

Earlier, in his opening statement, Dr. Califf had said his mother benefited directly from the accelerated approval of new drugs for multiple myeloma. Dr. Califf told Sen. Burr that he had spent “countless hours with patient groups” and understands the need to speed the approval of medicines for serious diseases.

But the FDA also has to make sure it holds up its end of the bargain struck with accelerated approvals. This involves checking on how these medicines work once they are marketed.

“We’re accepting that there’s more uncertainty,” Dr. Califf said. “That means we’ve got to have a better system to evaluate these products as they’re used on the market. And I think there are ways that we can do that now. Technology is making this possible in ways that it just was not possible before.”
 

Worries about the medical supply chain

Sen. Susan Collins (R-Maine) asked Dr. Califf about the vulnerability of the U.S. medical system to disruptions of the supply chain. She raised concerns about China’s dominance in antibiotic manufacturing as an example. She asked if Congress could do more to encourage domestic manufacturing of medical supplies, such as by offering tax incentives.

Dr. Califf told Sen. Collins he shared her concern about the U.S. manufacturing of ingredients used in both branded and generic drugs. He said he recently has served on a committee of the National Academy of Medicine that is examining supply chain issues.

This committee will soon release a report with specific recommendations, Dr. Califf said.

“We don’t have enough competitive entities in what’s become sort of a commodity business” of drug manufacturing, Dr. Califf said. “So we need a number of steps to make the system more resilient.”

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

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Delays in cancer referral, diagnosis linked with morbidities

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People with multiple preexisting chronic conditions experience a longer wait to receive a diagnosis of cancer and are more likely to be referred to an emergency department for their cancer, according to new research.

These findings are based on a retrospective study of data from 11,716 cancer patients from the United Kingdom’s National Cancer Diagnosis Audit – an initiative that aimed to better understand the journey of cancer patients from primary care to diagnosis. Three-quarters of the study participants had at least one morbidity in their primary care record, according to the authors of the new research, which was published in Family Practice (2021 Nov 30. doi: 10.1093/fampra/cmab139).

In their analysis of all of the patient data, Minjoung M. Koo and colleagues found that the median time between first presenting to a primary care physician with cancer symptoms and being referred to a specialist was 5 days. For all patients studied, the median time to receiving a cancer diagnosis was 42 days, the investigators wrote.

Patients with multiple morbidities were 26% more likely to have their cancer diagnosed at least 60 days after the initial primary care consultation than were those without morbidities (95% confidence interval, 1.10-1.45). This was true after adjustment for confounders, including morbidity, sex, age, and cancer. Similarly, those with a Charlson score of 3 or above – signifying more severe comorbidities – had a 19% greater odds of being diagnosed more than 60 days after presenting to primary care (95% CI, 1.01-1.40)
 

Older adults ‘less likely to be screen-detected’

Dr. Fran Boyle, professor of medical oncology at the University of Sydney, Australia, said it wasn’t clear from the study whether people with multiple comorbidities may have symptoms that cloud the diagnostic process, or whether short primary care consultations may not allow for enough time to manage multiple issues.

“Older adults typically have more comorbidities, and they are less likely to be screen-detected; for example, breast cancer screening and bowel cancer screening typically stop after 75,” said Dr. Boyle, director of Patricia Ritchie Centre for Cancer Care and Research at Sydney’s Mater Hospital.

Dr. Boyle pointed to a recent systematic review in Australian rural oncology that suggested that patients with more comorbidities tend to be offered less intense treatment, and have higher operative mortality and morbidity, which can contribute to less effective therapy.
 

Referral delays seen in multiple patient groups

Ms. Koo, from the University College London and the National Disease Registration Service in the United Kingdom, and coauthors noted a nonsignificant trend toward increased intervals between primary care consultation and referral or diagnosis even in patients with one or more comorbidities.

A higher burden of comorbidities also meant patients were more likely to have more than one primary care consultation before being referred to a specialist. Those with three or more comorbidities were 21% more likely to have at least three consultations before referral, compared with patients with no comorbidities (95% CI, 1.05-1.40, P = .010).

Overall, 60% of the participants in the study experienced at least one investigation into whether they had cancer by a primary care clinician before being referred to a specialist.
 

 

 

Morbidities linked with emergency referral

The study also saw an association between morbidities and the likelihood of receiving an emergency referral. Those with three or more morbidities were 60% more likely to have an emergency referral than were those with no comorbidities. Those with a Charlson score of three or above were 61% more likely to be referred to an emergency department.

“The greater likelihood of clinical complexity or acute deterior­ation among individuals with multiple or severe chronic conditions means that an emergency referral may be clinically appropriate,” the authors wrote.

Commenting on the findings, Dr. Diane M. Harper, professor of family medicine at the University of Michigan, Ann Arbor, said primary care patients often have multiple chronic illnesses, and the relationship between the physician and patients determines how quickly symptoms of cancer are explored.

“What this work cannot explore is the quality of discussions between the physician and the patient, nor can it explore how the decision to go to the ED was made,” said Dr. Harper, president of the North American Primary Care Research Group. “Exploring these data would provide important information to the physician-patient dyad.”
 

Diagnostic difficulty might have been at play, according to authors

The investigators didn’t find any evidence of an interaction between cancer site, number of morbidities, and referral or diagnostic time, except in cases of colorectal cancer, where patients with multiple morbidities were more likely to experience a longer wait between primary care consultation and diagnosis.

The authors observed that diagnostic difficulty of the cancer might have been at play here, given that colorectal cancer can have a broad symptom signature.

“This was less often observed among patients diagnosed with a cancer that had a narrow symptom signature (“easy” diagnostic difficulty, e.g. breast cancer) or a broad symptom signature of mostly low PPVs (“hard” diagnostic difficulty, e.g. brain cancer),” they wrote.

The authors concluded that “it is reasonable to sug­gest that both improvement efforts and future research in this field should target patients with multiple or severe morbidity, and explore the reasons for prolonged diagnostic intervals in specialist care.”

The study was supported by Cancer Research UK. The authors and experts interviewed for this piece did not declare having any conflicts of interest.

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People with multiple preexisting chronic conditions experience a longer wait to receive a diagnosis of cancer and are more likely to be referred to an emergency department for their cancer, according to new research.

These findings are based on a retrospective study of data from 11,716 cancer patients from the United Kingdom’s National Cancer Diagnosis Audit – an initiative that aimed to better understand the journey of cancer patients from primary care to diagnosis. Three-quarters of the study participants had at least one morbidity in their primary care record, according to the authors of the new research, which was published in Family Practice (2021 Nov 30. doi: 10.1093/fampra/cmab139).

In their analysis of all of the patient data, Minjoung M. Koo and colleagues found that the median time between first presenting to a primary care physician with cancer symptoms and being referred to a specialist was 5 days. For all patients studied, the median time to receiving a cancer diagnosis was 42 days, the investigators wrote.

Patients with multiple morbidities were 26% more likely to have their cancer diagnosed at least 60 days after the initial primary care consultation than were those without morbidities (95% confidence interval, 1.10-1.45). This was true after adjustment for confounders, including morbidity, sex, age, and cancer. Similarly, those with a Charlson score of 3 or above – signifying more severe comorbidities – had a 19% greater odds of being diagnosed more than 60 days after presenting to primary care (95% CI, 1.01-1.40)
 

Older adults ‘less likely to be screen-detected’

Dr. Fran Boyle, professor of medical oncology at the University of Sydney, Australia, said it wasn’t clear from the study whether people with multiple comorbidities may have symptoms that cloud the diagnostic process, or whether short primary care consultations may not allow for enough time to manage multiple issues.

“Older adults typically have more comorbidities, and they are less likely to be screen-detected; for example, breast cancer screening and bowel cancer screening typically stop after 75,” said Dr. Boyle, director of Patricia Ritchie Centre for Cancer Care and Research at Sydney’s Mater Hospital.

Dr. Boyle pointed to a recent systematic review in Australian rural oncology that suggested that patients with more comorbidities tend to be offered less intense treatment, and have higher operative mortality and morbidity, which can contribute to less effective therapy.
 

Referral delays seen in multiple patient groups

Ms. Koo, from the University College London and the National Disease Registration Service in the United Kingdom, and coauthors noted a nonsignificant trend toward increased intervals between primary care consultation and referral or diagnosis even in patients with one or more comorbidities.

A higher burden of comorbidities also meant patients were more likely to have more than one primary care consultation before being referred to a specialist. Those with three or more comorbidities were 21% more likely to have at least three consultations before referral, compared with patients with no comorbidities (95% CI, 1.05-1.40, P = .010).

Overall, 60% of the participants in the study experienced at least one investigation into whether they had cancer by a primary care clinician before being referred to a specialist.
 

 

 

Morbidities linked with emergency referral

The study also saw an association between morbidities and the likelihood of receiving an emergency referral. Those with three or more morbidities were 60% more likely to have an emergency referral than were those with no comorbidities. Those with a Charlson score of three or above were 61% more likely to be referred to an emergency department.

“The greater likelihood of clinical complexity or acute deterior­ation among individuals with multiple or severe chronic conditions means that an emergency referral may be clinically appropriate,” the authors wrote.

Commenting on the findings, Dr. Diane M. Harper, professor of family medicine at the University of Michigan, Ann Arbor, said primary care patients often have multiple chronic illnesses, and the relationship between the physician and patients determines how quickly symptoms of cancer are explored.

“What this work cannot explore is the quality of discussions between the physician and the patient, nor can it explore how the decision to go to the ED was made,” said Dr. Harper, president of the North American Primary Care Research Group. “Exploring these data would provide important information to the physician-patient dyad.”
 

Diagnostic difficulty might have been at play, according to authors

The investigators didn’t find any evidence of an interaction between cancer site, number of morbidities, and referral or diagnostic time, except in cases of colorectal cancer, where patients with multiple morbidities were more likely to experience a longer wait between primary care consultation and diagnosis.

The authors observed that diagnostic difficulty of the cancer might have been at play here, given that colorectal cancer can have a broad symptom signature.

“This was less often observed among patients diagnosed with a cancer that had a narrow symptom signature (“easy” diagnostic difficulty, e.g. breast cancer) or a broad symptom signature of mostly low PPVs (“hard” diagnostic difficulty, e.g. brain cancer),” they wrote.

The authors concluded that “it is reasonable to sug­gest that both improvement efforts and future research in this field should target patients with multiple or severe morbidity, and explore the reasons for prolonged diagnostic intervals in specialist care.”

The study was supported by Cancer Research UK. The authors and experts interviewed for this piece did not declare having any conflicts of interest.

People with multiple preexisting chronic conditions experience a longer wait to receive a diagnosis of cancer and are more likely to be referred to an emergency department for their cancer, according to new research.

These findings are based on a retrospective study of data from 11,716 cancer patients from the United Kingdom’s National Cancer Diagnosis Audit – an initiative that aimed to better understand the journey of cancer patients from primary care to diagnosis. Three-quarters of the study participants had at least one morbidity in their primary care record, according to the authors of the new research, which was published in Family Practice (2021 Nov 30. doi: 10.1093/fampra/cmab139).

In their analysis of all of the patient data, Minjoung M. Koo and colleagues found that the median time between first presenting to a primary care physician with cancer symptoms and being referred to a specialist was 5 days. For all patients studied, the median time to receiving a cancer diagnosis was 42 days, the investigators wrote.

Patients with multiple morbidities were 26% more likely to have their cancer diagnosed at least 60 days after the initial primary care consultation than were those without morbidities (95% confidence interval, 1.10-1.45). This was true after adjustment for confounders, including morbidity, sex, age, and cancer. Similarly, those with a Charlson score of 3 or above – signifying more severe comorbidities – had a 19% greater odds of being diagnosed more than 60 days after presenting to primary care (95% CI, 1.01-1.40)
 

Older adults ‘less likely to be screen-detected’

Dr. Fran Boyle, professor of medical oncology at the University of Sydney, Australia, said it wasn’t clear from the study whether people with multiple comorbidities may have symptoms that cloud the diagnostic process, or whether short primary care consultations may not allow for enough time to manage multiple issues.

“Older adults typically have more comorbidities, and they are less likely to be screen-detected; for example, breast cancer screening and bowel cancer screening typically stop after 75,” said Dr. Boyle, director of Patricia Ritchie Centre for Cancer Care and Research at Sydney’s Mater Hospital.

Dr. Boyle pointed to a recent systematic review in Australian rural oncology that suggested that patients with more comorbidities tend to be offered less intense treatment, and have higher operative mortality and morbidity, which can contribute to less effective therapy.
 

Referral delays seen in multiple patient groups

Ms. Koo, from the University College London and the National Disease Registration Service in the United Kingdom, and coauthors noted a nonsignificant trend toward increased intervals between primary care consultation and referral or diagnosis even in patients with one or more comorbidities.

A higher burden of comorbidities also meant patients were more likely to have more than one primary care consultation before being referred to a specialist. Those with three or more comorbidities were 21% more likely to have at least three consultations before referral, compared with patients with no comorbidities (95% CI, 1.05-1.40, P = .010).

Overall, 60% of the participants in the study experienced at least one investigation into whether they had cancer by a primary care clinician before being referred to a specialist.
 

 

 

Morbidities linked with emergency referral

The study also saw an association between morbidities and the likelihood of receiving an emergency referral. Those with three or more morbidities were 60% more likely to have an emergency referral than were those with no comorbidities. Those with a Charlson score of three or above were 61% more likely to be referred to an emergency department.

“The greater likelihood of clinical complexity or acute deterior­ation among individuals with multiple or severe chronic conditions means that an emergency referral may be clinically appropriate,” the authors wrote.

Commenting on the findings, Dr. Diane M. Harper, professor of family medicine at the University of Michigan, Ann Arbor, said primary care patients often have multiple chronic illnesses, and the relationship between the physician and patients determines how quickly symptoms of cancer are explored.

“What this work cannot explore is the quality of discussions between the physician and the patient, nor can it explore how the decision to go to the ED was made,” said Dr. Harper, president of the North American Primary Care Research Group. “Exploring these data would provide important information to the physician-patient dyad.”
 

Diagnostic difficulty might have been at play, according to authors

The investigators didn’t find any evidence of an interaction between cancer site, number of morbidities, and referral or diagnostic time, except in cases of colorectal cancer, where patients with multiple morbidities were more likely to experience a longer wait between primary care consultation and diagnosis.

The authors observed that diagnostic difficulty of the cancer might have been at play here, given that colorectal cancer can have a broad symptom signature.

“This was less often observed among patients diagnosed with a cancer that had a narrow symptom signature (“easy” diagnostic difficulty, e.g. breast cancer) or a broad symptom signature of mostly low PPVs (“hard” diagnostic difficulty, e.g. brain cancer),” they wrote.

The authors concluded that “it is reasonable to sug­gest that both improvement efforts and future research in this field should target patients with multiple or severe morbidity, and explore the reasons for prolonged diagnostic intervals in specialist care.”

The study was supported by Cancer Research UK. The authors and experts interviewed for this piece did not declare having any conflicts of interest.

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A case-based framework for de-escalating conflict

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Hospital medicine can be a demanding and fast-paced environment where resources are stretched thin, with both clinicians and patients stressed. A hospitalist’s role is dynamic, serving as an advocate, leader, or role model while working with interdisciplinary and diverse teams for the welfare of the patient. This constellation of pressures makes a degree of conflict inevitable.

Dr. Rachna Rawal

Often, an unexpected scenario can render the hospitalist uncertain and yet the hospitalist’s response can escalate or deescalate conflict. The multiple roles that a hospitalist represents may buckle to the single role of advocating for themselves, a colleague, or a patient in a tense scenario. When this happens, many hospitalists feel disempowered to respond.

De-escalation is a practical skill that involves being calm, respectful, and open minded toward the other person, while also maintaining boundaries. Here we provide case-based tips and skills that highlight the role for de-escalation.

Questions to ask yourself in midst of conflict:

  • How did the problematic behavior make you feel?
  • What will be your approach in handling this?
  • When should you address this?
  • What is the outcome you are hoping to achieve?
  • What is the outcome the other person is hoping to achieve?

Case 1

There is a female physician rounding with your team. Introductions were made at the start of a patient encounter. The patient repeatedly calls the female physician by her first name and refers to a male colleague as “doctor.”

Commentary: This scenario is commonly encountered by women who are physicians. They may be mistaken for the nurse, a technician, or a housekeeper. This exacerbates inequality and impostor syndrome as women can feel unheard, undervalued, and not recognized for their expertise and achievements. It can be challenging for a woman to reaffirm herself as she worries that the patient will not respect her or will think that she is being aggressive.

Dr. Alison K. Ashford


Approach: It is vital to interject by firmly reintroducing the female physician by her correct title. If you are the subject of this scenario, you may interject by firmly reintroducing yourself. If the patient or a colleague continues to refer to her by her first name, it is appropriate to say, “Please call her Dr. XYZ.” There is likely another female colleague or trainee nearby that will view this scenario as a model for setting boundaries.

To prevent similar future situations, consistently refer to all peers by their title in front of patients and peers in all professional settings (such as lectures, luncheons, etc.) to establish this as a cultural norm. Also, utilize hospital badges that clearly display roles in large letters.
 

Case 2

During sign out from a colleague, the colleague repeatedly refers to a patient hospitalized with sickle cell disease as a “frequent flyer” and “drug seeker,” and then remarks, “you know how these patients are.”

Commentary: A situation like this raises concerns about bias and stereotyping. Everyone has implicit bias. Recognizing and acknowledging when implicit bias affects objectivity in patient care is vital to providing appropriate care. It can be intimidating to broach this subject with a colleague as it may cause the colleague to become defensive and uncomfortable as revealing another person’s bias can be difficult. But physicians owe it to a patient’s wellbeing to remain objective and to prevent future colleagues from providing subpar care as a result.

Dr. Nicole Lee


Approach: In this case, saying, “Sometimes my previous experiences can affect my thinking. Will you explain what behaviors the patient has shown this admission that are concerning to you? This will allow me to grasp the complexity of the situation.” Another strategy is to share that there are new recommendations for how to use language about patients with sickle cell disease and patients who require opioids as a part of their treatment plan. Your hospitalist group could have a journal club on how bias affects patients and about the best practices in the care of people with sickle cell disease. A next step could be to build a quality improvement project to review the care of patients hospitalized for sickle cell disease or opioid use.
 

Case 3

You are conducting bedside rounds with your team. Your intern, a person of color, begins to present. The patient interjects by requesting that the intern leave as he “does not want a foreigner taking care” of him.

Dr. Eileen Barrett

Commentary: Requests like this can be shocking. The team leader has a responsibility to immediately act to ensure the psychological safety of the team. Ideally, your response should set firm boundaries and expectations that support the learner as a valued and respected clinician and allow the intern to complete the presentation. In this scenario, regardless of the response the patient takes, it is vital to maintain a safe environment for the trainee. It is crucial to debrief with the team immediately after as an exchange of thoughts and emotions in a safe space can allow for everyone to feel welcome. Additionally, this debrief can provide insights to the team leader of how to address similar situations in the future. The opportunity to allow the intern to no longer follow the patient should be offered, and if the intern opts to no longer follow the patient, accommodations should be made.

Approach: “This physician is a member of the medical team, and we are all working together to provide you with the best care. Everyone on this team is an equal. We value diversity of our team members as it allows us to take care of all our patients. We respect you and expect respect for each member of the team. If you feel that you are unable to respect our team members right now, we will leave for now and return later.” To ensure the patient is provided with appropriate care, be sure to debrief with the patient’s nurse.
 

Conclusion

These scenarios represent some of the many complex interpersonal challenges hospitalists encounter. These approaches are suggestions that are open to improvement as de-escalation of a conflict is a critical and evolving skill and practice.

For more tips on managing conflict, consider reading “Crucial Conversations by Kerry Patterson and colleagues. These skills can provide the tools we need to recenter ourselves when we are in the midst of these challenging situations.
 

Dr. Rawal is clinical assistant professor of medicine at the University of Pittsburgh Medical Center. Dr. Ashford is assistant professor and program director in the department of internal medicine/pediatrics at the University of Nebraska Medical Center, Omaha. Dr. Lee and Dr. Barrett are based in the department of internal medicine, University of New Mexico School of Medicine, Albuquerque. This article is sponsored by the SHM Physicians in Training (PIT) committee, which submits quarterly content to The Hospitalist on topics relevant to trainees and early career hospitalists.
 

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Hospital medicine can be a demanding and fast-paced environment where resources are stretched thin, with both clinicians and patients stressed. A hospitalist’s role is dynamic, serving as an advocate, leader, or role model while working with interdisciplinary and diverse teams for the welfare of the patient. This constellation of pressures makes a degree of conflict inevitable.

Dr. Rachna Rawal

Often, an unexpected scenario can render the hospitalist uncertain and yet the hospitalist’s response can escalate or deescalate conflict. The multiple roles that a hospitalist represents may buckle to the single role of advocating for themselves, a colleague, or a patient in a tense scenario. When this happens, many hospitalists feel disempowered to respond.

De-escalation is a practical skill that involves being calm, respectful, and open minded toward the other person, while also maintaining boundaries. Here we provide case-based tips and skills that highlight the role for de-escalation.

Questions to ask yourself in midst of conflict:

  • How did the problematic behavior make you feel?
  • What will be your approach in handling this?
  • When should you address this?
  • What is the outcome you are hoping to achieve?
  • What is the outcome the other person is hoping to achieve?

Case 1

There is a female physician rounding with your team. Introductions were made at the start of a patient encounter. The patient repeatedly calls the female physician by her first name and refers to a male colleague as “doctor.”

Commentary: This scenario is commonly encountered by women who are physicians. They may be mistaken for the nurse, a technician, or a housekeeper. This exacerbates inequality and impostor syndrome as women can feel unheard, undervalued, and not recognized for their expertise and achievements. It can be challenging for a woman to reaffirm herself as she worries that the patient will not respect her or will think that she is being aggressive.

Dr. Alison K. Ashford


Approach: It is vital to interject by firmly reintroducing the female physician by her correct title. If you are the subject of this scenario, you may interject by firmly reintroducing yourself. If the patient or a colleague continues to refer to her by her first name, it is appropriate to say, “Please call her Dr. XYZ.” There is likely another female colleague or trainee nearby that will view this scenario as a model for setting boundaries.

To prevent similar future situations, consistently refer to all peers by their title in front of patients and peers in all professional settings (such as lectures, luncheons, etc.) to establish this as a cultural norm. Also, utilize hospital badges that clearly display roles in large letters.
 

Case 2

During sign out from a colleague, the colleague repeatedly refers to a patient hospitalized with sickle cell disease as a “frequent flyer” and “drug seeker,” and then remarks, “you know how these patients are.”

Commentary: A situation like this raises concerns about bias and stereotyping. Everyone has implicit bias. Recognizing and acknowledging when implicit bias affects objectivity in patient care is vital to providing appropriate care. It can be intimidating to broach this subject with a colleague as it may cause the colleague to become defensive and uncomfortable as revealing another person’s bias can be difficult. But physicians owe it to a patient’s wellbeing to remain objective and to prevent future colleagues from providing subpar care as a result.

Dr. Nicole Lee


Approach: In this case, saying, “Sometimes my previous experiences can affect my thinking. Will you explain what behaviors the patient has shown this admission that are concerning to you? This will allow me to grasp the complexity of the situation.” Another strategy is to share that there are new recommendations for how to use language about patients with sickle cell disease and patients who require opioids as a part of their treatment plan. Your hospitalist group could have a journal club on how bias affects patients and about the best practices in the care of people with sickle cell disease. A next step could be to build a quality improvement project to review the care of patients hospitalized for sickle cell disease or opioid use.
 

Case 3

You are conducting bedside rounds with your team. Your intern, a person of color, begins to present. The patient interjects by requesting that the intern leave as he “does not want a foreigner taking care” of him.

Dr. Eileen Barrett

Commentary: Requests like this can be shocking. The team leader has a responsibility to immediately act to ensure the psychological safety of the team. Ideally, your response should set firm boundaries and expectations that support the learner as a valued and respected clinician and allow the intern to complete the presentation. In this scenario, regardless of the response the patient takes, it is vital to maintain a safe environment for the trainee. It is crucial to debrief with the team immediately after as an exchange of thoughts and emotions in a safe space can allow for everyone to feel welcome. Additionally, this debrief can provide insights to the team leader of how to address similar situations in the future. The opportunity to allow the intern to no longer follow the patient should be offered, and if the intern opts to no longer follow the patient, accommodations should be made.

Approach: “This physician is a member of the medical team, and we are all working together to provide you with the best care. Everyone on this team is an equal. We value diversity of our team members as it allows us to take care of all our patients. We respect you and expect respect for each member of the team. If you feel that you are unable to respect our team members right now, we will leave for now and return later.” To ensure the patient is provided with appropriate care, be sure to debrief with the patient’s nurse.
 

Conclusion

These scenarios represent some of the many complex interpersonal challenges hospitalists encounter. These approaches are suggestions that are open to improvement as de-escalation of a conflict is a critical and evolving skill and practice.

For more tips on managing conflict, consider reading “Crucial Conversations by Kerry Patterson and colleagues. These skills can provide the tools we need to recenter ourselves when we are in the midst of these challenging situations.
 

Dr. Rawal is clinical assistant professor of medicine at the University of Pittsburgh Medical Center. Dr. Ashford is assistant professor and program director in the department of internal medicine/pediatrics at the University of Nebraska Medical Center, Omaha. Dr. Lee and Dr. Barrett are based in the department of internal medicine, University of New Mexico School of Medicine, Albuquerque. This article is sponsored by the SHM Physicians in Training (PIT) committee, which submits quarterly content to The Hospitalist on topics relevant to trainees and early career hospitalists.
 

Hospital medicine can be a demanding and fast-paced environment where resources are stretched thin, with both clinicians and patients stressed. A hospitalist’s role is dynamic, serving as an advocate, leader, or role model while working with interdisciplinary and diverse teams for the welfare of the patient. This constellation of pressures makes a degree of conflict inevitable.

Dr. Rachna Rawal

Often, an unexpected scenario can render the hospitalist uncertain and yet the hospitalist’s response can escalate or deescalate conflict. The multiple roles that a hospitalist represents may buckle to the single role of advocating for themselves, a colleague, or a patient in a tense scenario. When this happens, many hospitalists feel disempowered to respond.

De-escalation is a practical skill that involves being calm, respectful, and open minded toward the other person, while also maintaining boundaries. Here we provide case-based tips and skills that highlight the role for de-escalation.

Questions to ask yourself in midst of conflict:

  • How did the problematic behavior make you feel?
  • What will be your approach in handling this?
  • When should you address this?
  • What is the outcome you are hoping to achieve?
  • What is the outcome the other person is hoping to achieve?

Case 1

There is a female physician rounding with your team. Introductions were made at the start of a patient encounter. The patient repeatedly calls the female physician by her first name and refers to a male colleague as “doctor.”

Commentary: This scenario is commonly encountered by women who are physicians. They may be mistaken for the nurse, a technician, or a housekeeper. This exacerbates inequality and impostor syndrome as women can feel unheard, undervalued, and not recognized for their expertise and achievements. It can be challenging for a woman to reaffirm herself as she worries that the patient will not respect her or will think that she is being aggressive.

Dr. Alison K. Ashford


Approach: It is vital to interject by firmly reintroducing the female physician by her correct title. If you are the subject of this scenario, you may interject by firmly reintroducing yourself. If the patient or a colleague continues to refer to her by her first name, it is appropriate to say, “Please call her Dr. XYZ.” There is likely another female colleague or trainee nearby that will view this scenario as a model for setting boundaries.

To prevent similar future situations, consistently refer to all peers by their title in front of patients and peers in all professional settings (such as lectures, luncheons, etc.) to establish this as a cultural norm. Also, utilize hospital badges that clearly display roles in large letters.
 

Case 2

During sign out from a colleague, the colleague repeatedly refers to a patient hospitalized with sickle cell disease as a “frequent flyer” and “drug seeker,” and then remarks, “you know how these patients are.”

Commentary: A situation like this raises concerns about bias and stereotyping. Everyone has implicit bias. Recognizing and acknowledging when implicit bias affects objectivity in patient care is vital to providing appropriate care. It can be intimidating to broach this subject with a colleague as it may cause the colleague to become defensive and uncomfortable as revealing another person’s bias can be difficult. But physicians owe it to a patient’s wellbeing to remain objective and to prevent future colleagues from providing subpar care as a result.

Dr. Nicole Lee


Approach: In this case, saying, “Sometimes my previous experiences can affect my thinking. Will you explain what behaviors the patient has shown this admission that are concerning to you? This will allow me to grasp the complexity of the situation.” Another strategy is to share that there are new recommendations for how to use language about patients with sickle cell disease and patients who require opioids as a part of their treatment plan. Your hospitalist group could have a journal club on how bias affects patients and about the best practices in the care of people with sickle cell disease. A next step could be to build a quality improvement project to review the care of patients hospitalized for sickle cell disease or opioid use.
 

Case 3

You are conducting bedside rounds with your team. Your intern, a person of color, begins to present. The patient interjects by requesting that the intern leave as he “does not want a foreigner taking care” of him.

Dr. Eileen Barrett

Commentary: Requests like this can be shocking. The team leader has a responsibility to immediately act to ensure the psychological safety of the team. Ideally, your response should set firm boundaries and expectations that support the learner as a valued and respected clinician and allow the intern to complete the presentation. In this scenario, regardless of the response the patient takes, it is vital to maintain a safe environment for the trainee. It is crucial to debrief with the team immediately after as an exchange of thoughts and emotions in a safe space can allow for everyone to feel welcome. Additionally, this debrief can provide insights to the team leader of how to address similar situations in the future. The opportunity to allow the intern to no longer follow the patient should be offered, and if the intern opts to no longer follow the patient, accommodations should be made.

Approach: “This physician is a member of the medical team, and we are all working together to provide you with the best care. Everyone on this team is an equal. We value diversity of our team members as it allows us to take care of all our patients. We respect you and expect respect for each member of the team. If you feel that you are unable to respect our team members right now, we will leave for now and return later.” To ensure the patient is provided with appropriate care, be sure to debrief with the patient’s nurse.
 

Conclusion

These scenarios represent some of the many complex interpersonal challenges hospitalists encounter. These approaches are suggestions that are open to improvement as de-escalation of a conflict is a critical and evolving skill and practice.

For more tips on managing conflict, consider reading “Crucial Conversations by Kerry Patterson and colleagues. These skills can provide the tools we need to recenter ourselves when we are in the midst of these challenging situations.
 

Dr. Rawal is clinical assistant professor of medicine at the University of Pittsburgh Medical Center. Dr. Ashford is assistant professor and program director in the department of internal medicine/pediatrics at the University of Nebraska Medical Center, Omaha. Dr. Lee and Dr. Barrett are based in the department of internal medicine, University of New Mexico School of Medicine, Albuquerque. This article is sponsored by the SHM Physicians in Training (PIT) committee, which submits quarterly content to The Hospitalist on topics relevant to trainees and early career hospitalists.
 

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Electrocuted by 11,000 volts, now a triple amputee ... and an MD

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Bruce “BJ” Miller Jr., a 19-year-old Princeton (N.J.) University sophomore, was horsing around with friends near a train track in 1990 when they spotted a parked commuter train. They decided to climb over the train, and Mr. Miller was first up the ladder.

Courtesy BJ Miller
Friends visit BJ Miller in the hospital shortly after he was electrocuted.
Suddenly, electricity from the nearby powerlines arched to Mr. Miller’s metal watch, shooting 11,000 volts of electricity through his body.

An explosion ripped through the air, and Mr. Miller was thrown on top of the train, his body smoking. His petrified friends called for an ambulance.

Clinging to life, Mr. Miller was airlifted to the burn unit at Saint Barnabas Medical Center in Livingston, N.J..

Physicians saved Mr. Miller’s life, but they had to amputate both of his legs below the knees and his left arm below the elbow.

“With electricity, you burn from the inside out,” said Mr. Miller, now 50. “The voltage enters your body – in my case, the wrist – and runs around internally until it finds a way out. That is often the lower extremities as the ground tends to ground the current, but not always. In my case, the current tried to come through my chest – which is also burned and required skin grafting – but not enough to spare my legs. I think I had a half-dozen or so surgeries over the first month or 2 at the hospital.”
 

Waking up to a new body

Mr. Miller doesn’t remember much about the accident, but he recalls waking up a few days later in the ICU and feeling the need to use the bathroom. Disoriented, Mr. Miller pulled off his ventilator, climbed out of bed, and tried to walk forward, unaware of his injuries. His feet and legs had not yet been amputated. When the catheter line ran out of slack, he collapsed.

“Eventually, a nurse came rushing in, responding to the ventilator alarm bells going off,” Mr. Miller said. “My dad wasn’t far behind. It became clear to me then that this was not a dream and [I realized] what had happened and why I was in the hospital.” 

For months, Mr. Miller lived in the burn unit, undergoing countless skin grafts and surgeries. Because viable and nonviable tissue take time to be revealed after burns, surgeons take the minimum amount of tissue during each operation to give damaged tissue a chance to heal, he explained. In Mr. Miller’s case, his feet were amputated first, and later, his legs.

“In those early days from the hospital bed, my mind turned to issues related to identity,” he said. “What do I do with myself? What is the meaning of my life now? I was challenged in those ways. I had to think through who I was, and who I wanted to become.”

Mr. Miller eventually moved to the Rehabilitation Institute of Chicago (now called The Shirley Ryan AbilityLab), where he started the grueling process of rebuilding his strength and learning to walk on prosthetic legs.

“Any one day was filled with a mix of optimism and good fight and 5 minutes later, exasperation, frustration, tons of pain, and insecurity about my body,” he said. “My family and friends held the gate for me in a way, but a lot of the work was up to me. I had to believe that I deserved this love, that I wanted to be alive, and that there was still something here for me.”

Courtesy BJ Miller
BJ Miller lifts weights in the gym during physical therapy.

Mr. Miller didn’t have to look far for inspiration. His mom had lived with polio for most of her life and acquired post-polio syndrome as she grew older, he said. When he was a child, his mom walked with crutches, and she became wheelchair-dependent by the time he was a teenager. 

After the first surgery to amputate his feet, Mr. Miller and his mom shared a deep discussion about his joining the ranks of “the disabled,” and how their connection was now even stronger.

“In this way, the injuries unlocked even more experiences to share between us, and more love to feel, and therefore some early sense of gain to complement all the losses happening,” he said. “She had taught me so much about living with disability and had given me all the tools I needed to refashion my sense of self.”
 

 

 

From burn patient to medical student

After returning to Princeton University and finishing his undergraduate degree, Mr. Miller decided to go into medicine. He wanted to use his experience to help patients and find ways to improve weaknesses in the health care system, he said. But he made a deal with himself that he wouldn’t become a doctor for the sake of becoming one; he would enter the vocation only if he could do the work and enjoy the job.

“I wasn’t sure if I could do it,” he said. “There weren’t a lot of triple amputees to point to, to say whether this was even mechanically possible, to get through the training. The medical institutions I spoke with knew they had some obligation by law to protect me, but there’s also an obligation that I need to be able to fulfill the competencies. This was uncharted water.”

Because his greatest physical challenge was standing for long periods, instructors at the University of California, San Francisco, made accommodations to alleviate the strain. His clinical rotations for example, were organized near his home to limit the need for travel. On surgical rotations, he was allowed to sit on a stool.

Medical training progressed smoothly until Mr. Miller completed a rotation in his chosen specialty, rehabilitation medicine. He didn’t enjoy it. The passion and meaning he hoped to find was missing. Disillusioned, and with his final year in medical school coming to an end, Mr. Miller dropped out of the Match program. Around the same time, his sister, Lisa, died by suicide.

“My whole family life was in shambles,” he said. “I felt like, ‘I can’t even help my sister, how am I going to help other people?’ ”

Mr. Miller earned his MD and moved to his parents’ home in Milwaukee after his sister’s death. He was close to giving up on medicine, but his deans convinced him to do a post-doc internship. It was as an intern at the Medical College of Wisconsin, Milwaukee, that he completed an elective in palliative care. 

“I fell immediately in love with it the first day,” he said. “This was a field devoted to working with things you can’t change and dealing with a lack of control, what it’s like to live with these diagnoses. This was a place where I could dig into my experience and share that with patients and families. This was a place where my life story had something to offer.”
 

Creating a new form of palliative care

Dr. Miller went on to complete a fellowship at Harvard Medical School, Boston, in hospice and palliative medicine. He became a palliative care physician at UCSF Health, and later directed the Zen Hospice Project, a nonprofit dedicated to teaching mindfulness-based caregiving for professionals, family members, and caregivers.

Courtesy BJ Miller
Dr. BJ Miller waits before a recent speaking event with his dog, Maysie.

Gayle Kojimoto, a program manager who worked with Dr. Miller at UCSF’s outpatient palliative care clinic for cancer patients, said Miller was a favorite among patients because of his authenticity and his ability to make them feel understood.

“Patients love him because he is 100% present with them,” said Ms. Kojimoto. “They feel like he can understand their suffering better than other docs. He’s open to hearing about their suffering, when others may not be, and he doesn’t judge them. Many patients have said that seeing him is better than seeing a therapist.”

In 2020, Dr. Miller cofounded Mettle Health, a first-of-its-kind company that aims to reframe the way people think about their well-being as it relates to chronic and serious illness. Mettle Health’s care team provides consultations on a range of topics, including practical, emotional, and existential issues. No physician referrals are needed.

When the pandemic started, Dr. Miller said he and his colleagues felt the moment was ripe for bringing palliative care online to increase access, while decreasing caregiver and clinician burnout.

“We set up Mettle Health as an online palliative care counseling and coaching business and we pulled it out of the healthcare system so that whether you’re a patient or a caregiver you don’t need to satisfy some insurance need to get this kind of care,” he said. “We also realized there are enough people writing prescriptions. The medical piece is relatively well tended to; it’s the psychosocial and spiritual issues, and the existential issues, that are so underdeveloped. We are a social service, not a medical service, and this allows us to complement existing structures of care rather than compete with them.”

Having Dr. Miller as a leader for Mettle Health is a huge driver for why people seek out the company, said Sonya Dolan, director of operations and cofounder of Mettle Health.

“His approach to working with patients, caregivers, and clinicians is something I think sets us apart and makes us special,” she said. “His way of thinking about serious illness and death and dying is incredibly unique and he has a way of talking about and humanizing something that’s scary for a lot of us.”
 

 

 

‘Surprised by how much I can still do’

Since the accident, Dr. Miller has come a long way in navigating his physical limitations. In the early years, Dr. Miller said he was determined to do as many activities as he still could. He skied, biked, and pushed himself to stand for long periods on his prosthetic legs.  

“For years, I would force myself to do these things just to prove I could, but not really enjoy them,” he said. “I’d get out on the dance floor or put myself out in vulnerable social situations where I might fall. It was kind of brutal and difficult. But at about year 5 or so, I became much more at ease with myself and more at peace with myself.”

Today, Dr. Miller’s prosthetics make nearly all ambulatory activities possible, but he concentrates on the activities that bring him joy.

“Probably the thing I can still do that surprises people most, including myself, is riding a motorcycle,” he said. “As for my upper body, I’m thoroughly used to living with only one hand and I continue to be surprised at how much I can still do. With enough time and experimentation, I can usually find a way to do what I need/want to do. It took me awhile to figure out how to clap! Now I just pound my chest for the same effect!”

Dr. Miller is an animal-lover and said his pets and nature are a large part of his self-care. His dog Maysie travels nearly everywhere with him and his cats, the Muffin Man and Darkness, enjoy making guest appearances on his Zoom calls. The physician frequently visits the desert in southern Utah and said he loves the arts, architecture, and design.

Dr. Miller’s advice for others who are disabled and want to go into medicine? Live out loud with your truths and be open about your disabilities. Too often, disabled individuals hide their disabilities, lie about them, or shield the world from their story, he said. 

“These are rich, ripe experiences that are incredibly valuable to someone who wants to go out and be of service in the world,” he said. “We should be proud of our experiences as disabled people. The creativity we’ve had to exercise, the workarounds we’ve had to employ, these should not be points of embarrassment, but points of pride. Anyone who wants to pursue clinical training of any kind should use these experiences explicitly. These are sources of strength, not something to be forgiven or tolerated or accommodated.” 

The same goes for physicians who do not have disabilities but who have lived through hardship, pain, struggle, or adversity, he emphasized.

“Find a way to learn from them, find a way to own them,” he said. “Use them as a source of strength and the rest of the world will respond to you differently.”

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

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Bruce “BJ” Miller Jr., a 19-year-old Princeton (N.J.) University sophomore, was horsing around with friends near a train track in 1990 when they spotted a parked commuter train. They decided to climb over the train, and Mr. Miller was first up the ladder.

Courtesy BJ Miller
Friends visit BJ Miller in the hospital shortly after he was electrocuted.
Suddenly, electricity from the nearby powerlines arched to Mr. Miller’s metal watch, shooting 11,000 volts of electricity through his body.

An explosion ripped through the air, and Mr. Miller was thrown on top of the train, his body smoking. His petrified friends called for an ambulance.

Clinging to life, Mr. Miller was airlifted to the burn unit at Saint Barnabas Medical Center in Livingston, N.J..

Physicians saved Mr. Miller’s life, but they had to amputate both of his legs below the knees and his left arm below the elbow.

“With electricity, you burn from the inside out,” said Mr. Miller, now 50. “The voltage enters your body – in my case, the wrist – and runs around internally until it finds a way out. That is often the lower extremities as the ground tends to ground the current, but not always. In my case, the current tried to come through my chest – which is also burned and required skin grafting – but not enough to spare my legs. I think I had a half-dozen or so surgeries over the first month or 2 at the hospital.”
 

Waking up to a new body

Mr. Miller doesn’t remember much about the accident, but he recalls waking up a few days later in the ICU and feeling the need to use the bathroom. Disoriented, Mr. Miller pulled off his ventilator, climbed out of bed, and tried to walk forward, unaware of his injuries. His feet and legs had not yet been amputated. When the catheter line ran out of slack, he collapsed.

“Eventually, a nurse came rushing in, responding to the ventilator alarm bells going off,” Mr. Miller said. “My dad wasn’t far behind. It became clear to me then that this was not a dream and [I realized] what had happened and why I was in the hospital.” 

For months, Mr. Miller lived in the burn unit, undergoing countless skin grafts and surgeries. Because viable and nonviable tissue take time to be revealed after burns, surgeons take the minimum amount of tissue during each operation to give damaged tissue a chance to heal, he explained. In Mr. Miller’s case, his feet were amputated first, and later, his legs.

“In those early days from the hospital bed, my mind turned to issues related to identity,” he said. “What do I do with myself? What is the meaning of my life now? I was challenged in those ways. I had to think through who I was, and who I wanted to become.”

Mr. Miller eventually moved to the Rehabilitation Institute of Chicago (now called The Shirley Ryan AbilityLab), where he started the grueling process of rebuilding his strength and learning to walk on prosthetic legs.

“Any one day was filled with a mix of optimism and good fight and 5 minutes later, exasperation, frustration, tons of pain, and insecurity about my body,” he said. “My family and friends held the gate for me in a way, but a lot of the work was up to me. I had to believe that I deserved this love, that I wanted to be alive, and that there was still something here for me.”

Courtesy BJ Miller
BJ Miller lifts weights in the gym during physical therapy.

Mr. Miller didn’t have to look far for inspiration. His mom had lived with polio for most of her life and acquired post-polio syndrome as she grew older, he said. When he was a child, his mom walked with crutches, and she became wheelchair-dependent by the time he was a teenager. 

After the first surgery to amputate his feet, Mr. Miller and his mom shared a deep discussion about his joining the ranks of “the disabled,” and how their connection was now even stronger.

“In this way, the injuries unlocked even more experiences to share between us, and more love to feel, and therefore some early sense of gain to complement all the losses happening,” he said. “She had taught me so much about living with disability and had given me all the tools I needed to refashion my sense of self.”
 

 

 

From burn patient to medical student

After returning to Princeton University and finishing his undergraduate degree, Mr. Miller decided to go into medicine. He wanted to use his experience to help patients and find ways to improve weaknesses in the health care system, he said. But he made a deal with himself that he wouldn’t become a doctor for the sake of becoming one; he would enter the vocation only if he could do the work and enjoy the job.

“I wasn’t sure if I could do it,” he said. “There weren’t a lot of triple amputees to point to, to say whether this was even mechanically possible, to get through the training. The medical institutions I spoke with knew they had some obligation by law to protect me, but there’s also an obligation that I need to be able to fulfill the competencies. This was uncharted water.”

Because his greatest physical challenge was standing for long periods, instructors at the University of California, San Francisco, made accommodations to alleviate the strain. His clinical rotations for example, were organized near his home to limit the need for travel. On surgical rotations, he was allowed to sit on a stool.

Medical training progressed smoothly until Mr. Miller completed a rotation in his chosen specialty, rehabilitation medicine. He didn’t enjoy it. The passion and meaning he hoped to find was missing. Disillusioned, and with his final year in medical school coming to an end, Mr. Miller dropped out of the Match program. Around the same time, his sister, Lisa, died by suicide.

“My whole family life was in shambles,” he said. “I felt like, ‘I can’t even help my sister, how am I going to help other people?’ ”

Mr. Miller earned his MD and moved to his parents’ home in Milwaukee after his sister’s death. He was close to giving up on medicine, but his deans convinced him to do a post-doc internship. It was as an intern at the Medical College of Wisconsin, Milwaukee, that he completed an elective in palliative care. 

“I fell immediately in love with it the first day,” he said. “This was a field devoted to working with things you can’t change and dealing with a lack of control, what it’s like to live with these diagnoses. This was a place where I could dig into my experience and share that with patients and families. This was a place where my life story had something to offer.”
 

Creating a new form of palliative care

Dr. Miller went on to complete a fellowship at Harvard Medical School, Boston, in hospice and palliative medicine. He became a palliative care physician at UCSF Health, and later directed the Zen Hospice Project, a nonprofit dedicated to teaching mindfulness-based caregiving for professionals, family members, and caregivers.

Courtesy BJ Miller
Dr. BJ Miller waits before a recent speaking event with his dog, Maysie.

Gayle Kojimoto, a program manager who worked with Dr. Miller at UCSF’s outpatient palliative care clinic for cancer patients, said Miller was a favorite among patients because of his authenticity and his ability to make them feel understood.

“Patients love him because he is 100% present with them,” said Ms. Kojimoto. “They feel like he can understand their suffering better than other docs. He’s open to hearing about their suffering, when others may not be, and he doesn’t judge them. Many patients have said that seeing him is better than seeing a therapist.”

In 2020, Dr. Miller cofounded Mettle Health, a first-of-its-kind company that aims to reframe the way people think about their well-being as it relates to chronic and serious illness. Mettle Health’s care team provides consultations on a range of topics, including practical, emotional, and existential issues. No physician referrals are needed.

When the pandemic started, Dr. Miller said he and his colleagues felt the moment was ripe for bringing palliative care online to increase access, while decreasing caregiver and clinician burnout.

“We set up Mettle Health as an online palliative care counseling and coaching business and we pulled it out of the healthcare system so that whether you’re a patient or a caregiver you don’t need to satisfy some insurance need to get this kind of care,” he said. “We also realized there are enough people writing prescriptions. The medical piece is relatively well tended to; it’s the psychosocial and spiritual issues, and the existential issues, that are so underdeveloped. We are a social service, not a medical service, and this allows us to complement existing structures of care rather than compete with them.”

Having Dr. Miller as a leader for Mettle Health is a huge driver for why people seek out the company, said Sonya Dolan, director of operations and cofounder of Mettle Health.

“His approach to working with patients, caregivers, and clinicians is something I think sets us apart and makes us special,” she said. “His way of thinking about serious illness and death and dying is incredibly unique and he has a way of talking about and humanizing something that’s scary for a lot of us.”
 

 

 

‘Surprised by how much I can still do’

Since the accident, Dr. Miller has come a long way in navigating his physical limitations. In the early years, Dr. Miller said he was determined to do as many activities as he still could. He skied, biked, and pushed himself to stand for long periods on his prosthetic legs.  

“For years, I would force myself to do these things just to prove I could, but not really enjoy them,” he said. “I’d get out on the dance floor or put myself out in vulnerable social situations where I might fall. It was kind of brutal and difficult. But at about year 5 or so, I became much more at ease with myself and more at peace with myself.”

Today, Dr. Miller’s prosthetics make nearly all ambulatory activities possible, but he concentrates on the activities that bring him joy.

“Probably the thing I can still do that surprises people most, including myself, is riding a motorcycle,” he said. “As for my upper body, I’m thoroughly used to living with only one hand and I continue to be surprised at how much I can still do. With enough time and experimentation, I can usually find a way to do what I need/want to do. It took me awhile to figure out how to clap! Now I just pound my chest for the same effect!”

Dr. Miller is an animal-lover and said his pets and nature are a large part of his self-care. His dog Maysie travels nearly everywhere with him and his cats, the Muffin Man and Darkness, enjoy making guest appearances on his Zoom calls. The physician frequently visits the desert in southern Utah and said he loves the arts, architecture, and design.

Dr. Miller’s advice for others who are disabled and want to go into medicine? Live out loud with your truths and be open about your disabilities. Too often, disabled individuals hide their disabilities, lie about them, or shield the world from their story, he said. 

“These are rich, ripe experiences that are incredibly valuable to someone who wants to go out and be of service in the world,” he said. “We should be proud of our experiences as disabled people. The creativity we’ve had to exercise, the workarounds we’ve had to employ, these should not be points of embarrassment, but points of pride. Anyone who wants to pursue clinical training of any kind should use these experiences explicitly. These are sources of strength, not something to be forgiven or tolerated or accommodated.” 

The same goes for physicians who do not have disabilities but who have lived through hardship, pain, struggle, or adversity, he emphasized.

“Find a way to learn from them, find a way to own them,” he said. “Use them as a source of strength and the rest of the world will respond to you differently.”

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

Bruce “BJ” Miller Jr., a 19-year-old Princeton (N.J.) University sophomore, was horsing around with friends near a train track in 1990 when they spotted a parked commuter train. They decided to climb over the train, and Mr. Miller was first up the ladder.

Courtesy BJ Miller
Friends visit BJ Miller in the hospital shortly after he was electrocuted.
Suddenly, electricity from the nearby powerlines arched to Mr. Miller’s metal watch, shooting 11,000 volts of electricity through his body.

An explosion ripped through the air, and Mr. Miller was thrown on top of the train, his body smoking. His petrified friends called for an ambulance.

Clinging to life, Mr. Miller was airlifted to the burn unit at Saint Barnabas Medical Center in Livingston, N.J..

Physicians saved Mr. Miller’s life, but they had to amputate both of his legs below the knees and his left arm below the elbow.

“With electricity, you burn from the inside out,” said Mr. Miller, now 50. “The voltage enters your body – in my case, the wrist – and runs around internally until it finds a way out. That is often the lower extremities as the ground tends to ground the current, but not always. In my case, the current tried to come through my chest – which is also burned and required skin grafting – but not enough to spare my legs. I think I had a half-dozen or so surgeries over the first month or 2 at the hospital.”
 

Waking up to a new body

Mr. Miller doesn’t remember much about the accident, but he recalls waking up a few days later in the ICU and feeling the need to use the bathroom. Disoriented, Mr. Miller pulled off his ventilator, climbed out of bed, and tried to walk forward, unaware of his injuries. His feet and legs had not yet been amputated. When the catheter line ran out of slack, he collapsed.

“Eventually, a nurse came rushing in, responding to the ventilator alarm bells going off,” Mr. Miller said. “My dad wasn’t far behind. It became clear to me then that this was not a dream and [I realized] what had happened and why I was in the hospital.” 

For months, Mr. Miller lived in the burn unit, undergoing countless skin grafts and surgeries. Because viable and nonviable tissue take time to be revealed after burns, surgeons take the minimum amount of tissue during each operation to give damaged tissue a chance to heal, he explained. In Mr. Miller’s case, his feet were amputated first, and later, his legs.

“In those early days from the hospital bed, my mind turned to issues related to identity,” he said. “What do I do with myself? What is the meaning of my life now? I was challenged in those ways. I had to think through who I was, and who I wanted to become.”

Mr. Miller eventually moved to the Rehabilitation Institute of Chicago (now called The Shirley Ryan AbilityLab), where he started the grueling process of rebuilding his strength and learning to walk on prosthetic legs.

“Any one day was filled with a mix of optimism and good fight and 5 minutes later, exasperation, frustration, tons of pain, and insecurity about my body,” he said. “My family and friends held the gate for me in a way, but a lot of the work was up to me. I had to believe that I deserved this love, that I wanted to be alive, and that there was still something here for me.”

Courtesy BJ Miller
BJ Miller lifts weights in the gym during physical therapy.

Mr. Miller didn’t have to look far for inspiration. His mom had lived with polio for most of her life and acquired post-polio syndrome as she grew older, he said. When he was a child, his mom walked with crutches, and she became wheelchair-dependent by the time he was a teenager. 

After the first surgery to amputate his feet, Mr. Miller and his mom shared a deep discussion about his joining the ranks of “the disabled,” and how their connection was now even stronger.

“In this way, the injuries unlocked even more experiences to share between us, and more love to feel, and therefore some early sense of gain to complement all the losses happening,” he said. “She had taught me so much about living with disability and had given me all the tools I needed to refashion my sense of self.”
 

 

 

From burn patient to medical student

After returning to Princeton University and finishing his undergraduate degree, Mr. Miller decided to go into medicine. He wanted to use his experience to help patients and find ways to improve weaknesses in the health care system, he said. But he made a deal with himself that he wouldn’t become a doctor for the sake of becoming one; he would enter the vocation only if he could do the work and enjoy the job.

“I wasn’t sure if I could do it,” he said. “There weren’t a lot of triple amputees to point to, to say whether this was even mechanically possible, to get through the training. The medical institutions I spoke with knew they had some obligation by law to protect me, but there’s also an obligation that I need to be able to fulfill the competencies. This was uncharted water.”

Because his greatest physical challenge was standing for long periods, instructors at the University of California, San Francisco, made accommodations to alleviate the strain. His clinical rotations for example, were organized near his home to limit the need for travel. On surgical rotations, he was allowed to sit on a stool.

Medical training progressed smoothly until Mr. Miller completed a rotation in his chosen specialty, rehabilitation medicine. He didn’t enjoy it. The passion and meaning he hoped to find was missing. Disillusioned, and with his final year in medical school coming to an end, Mr. Miller dropped out of the Match program. Around the same time, his sister, Lisa, died by suicide.

“My whole family life was in shambles,” he said. “I felt like, ‘I can’t even help my sister, how am I going to help other people?’ ”

Mr. Miller earned his MD and moved to his parents’ home in Milwaukee after his sister’s death. He was close to giving up on medicine, but his deans convinced him to do a post-doc internship. It was as an intern at the Medical College of Wisconsin, Milwaukee, that he completed an elective in palliative care. 

“I fell immediately in love with it the first day,” he said. “This was a field devoted to working with things you can’t change and dealing with a lack of control, what it’s like to live with these diagnoses. This was a place where I could dig into my experience and share that with patients and families. This was a place where my life story had something to offer.”
 

Creating a new form of palliative care

Dr. Miller went on to complete a fellowship at Harvard Medical School, Boston, in hospice and palliative medicine. He became a palliative care physician at UCSF Health, and later directed the Zen Hospice Project, a nonprofit dedicated to teaching mindfulness-based caregiving for professionals, family members, and caregivers.

Courtesy BJ Miller
Dr. BJ Miller waits before a recent speaking event with his dog, Maysie.

Gayle Kojimoto, a program manager who worked with Dr. Miller at UCSF’s outpatient palliative care clinic for cancer patients, said Miller was a favorite among patients because of his authenticity and his ability to make them feel understood.

“Patients love him because he is 100% present with them,” said Ms. Kojimoto. “They feel like he can understand their suffering better than other docs. He’s open to hearing about their suffering, when others may not be, and he doesn’t judge them. Many patients have said that seeing him is better than seeing a therapist.”

In 2020, Dr. Miller cofounded Mettle Health, a first-of-its-kind company that aims to reframe the way people think about their well-being as it relates to chronic and serious illness. Mettle Health’s care team provides consultations on a range of topics, including practical, emotional, and existential issues. No physician referrals are needed.

When the pandemic started, Dr. Miller said he and his colleagues felt the moment was ripe for bringing palliative care online to increase access, while decreasing caregiver and clinician burnout.

“We set up Mettle Health as an online palliative care counseling and coaching business and we pulled it out of the healthcare system so that whether you’re a patient or a caregiver you don’t need to satisfy some insurance need to get this kind of care,” he said. “We also realized there are enough people writing prescriptions. The medical piece is relatively well tended to; it’s the psychosocial and spiritual issues, and the existential issues, that are so underdeveloped. We are a social service, not a medical service, and this allows us to complement existing structures of care rather than compete with them.”

Having Dr. Miller as a leader for Mettle Health is a huge driver for why people seek out the company, said Sonya Dolan, director of operations and cofounder of Mettle Health.

“His approach to working with patients, caregivers, and clinicians is something I think sets us apart and makes us special,” she said. “His way of thinking about serious illness and death and dying is incredibly unique and he has a way of talking about and humanizing something that’s scary for a lot of us.”
 

 

 

‘Surprised by how much I can still do’

Since the accident, Dr. Miller has come a long way in navigating his physical limitations. In the early years, Dr. Miller said he was determined to do as many activities as he still could. He skied, biked, and pushed himself to stand for long periods on his prosthetic legs.  

“For years, I would force myself to do these things just to prove I could, but not really enjoy them,” he said. “I’d get out on the dance floor or put myself out in vulnerable social situations where I might fall. It was kind of brutal and difficult. But at about year 5 or so, I became much more at ease with myself and more at peace with myself.”

Today, Dr. Miller’s prosthetics make nearly all ambulatory activities possible, but he concentrates on the activities that bring him joy.

“Probably the thing I can still do that surprises people most, including myself, is riding a motorcycle,” he said. “As for my upper body, I’m thoroughly used to living with only one hand and I continue to be surprised at how much I can still do. With enough time and experimentation, I can usually find a way to do what I need/want to do. It took me awhile to figure out how to clap! Now I just pound my chest for the same effect!”

Dr. Miller is an animal-lover and said his pets and nature are a large part of his self-care. His dog Maysie travels nearly everywhere with him and his cats, the Muffin Man and Darkness, enjoy making guest appearances on his Zoom calls. The physician frequently visits the desert in southern Utah and said he loves the arts, architecture, and design.

Dr. Miller’s advice for others who are disabled and want to go into medicine? Live out loud with your truths and be open about your disabilities. Too often, disabled individuals hide their disabilities, lie about them, or shield the world from their story, he said. 

“These are rich, ripe experiences that are incredibly valuable to someone who wants to go out and be of service in the world,” he said. “We should be proud of our experiences as disabled people. The creativity we’ve had to exercise, the workarounds we’ve had to employ, these should not be points of embarrassment, but points of pride. Anyone who wants to pursue clinical training of any kind should use these experiences explicitly. These are sources of strength, not something to be forgiven or tolerated or accommodated.” 

The same goes for physicians who do not have disabilities but who have lived through hardship, pain, struggle, or adversity, he emphasized.

“Find a way to learn from them, find a way to own them,” he said. “Use them as a source of strength and the rest of the world will respond to you differently.”

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

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Yoga effective adjunct therapy in recurrent vasovagal syncope

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Changed

Yoga added to conventional therapy for vasovagal syncope (VVS), when patients faint after a sudden drop in heart rate and blood pressure, can reduce symptoms and improve quality of life, new research suggests. 

AndiP/pixabay.com

A small, open-label trial conducted in New Delhi showed that participants practicing yoga reported an improvement in VVS symptoms after only 6 weeks, with a reduction of 1.82 events at 12 months. All those practicing yoga also showed significantly improved quality of life (QoL) scores by the end of the trial.

“Yoga as add-on therapy in VVS is superior to medical therapy in reducing syncopal and presyncopal events and in improving the QoL,” report Gautam Sharma, MD, DM, Centre for Integrative Medicine and Research, All India Institute of Medical Sciences, New Delhi, and colleagues. “It may be useful to integrate a cost-effective and safe intervention such as yoga into the management of VVS.”

Results of the LIVE-Yoga study were published online in JACC: Clinical Electrophysiology.

Vasovagal syncope is a common and non–life-threatening condition, but given the severity and frequency of recurrence it can result in significant deterioration in a patient’s quality of life, the authors note. “Existing management therapies have been largely ineffective,” they write.

Recent trials have suggested some efficacy for yoga in diseases of autonomic imbalance, suggesting a possible use in VVS. To find out, the researchers enrolled adults with VVS between the ages of 15-70 years who had a positive head-up tilt test (HUTT) and at least two syncope or presyncope events within 3 months of enrollment. They also needed to be willing and able to practice yoga. Those with structural heart disease, accelerated hypertension, and underlying neurologic disorders were not included in the study.

A total of 55 patients were randomly assigned to receive either a specialized yoga training program in addition to guideline-based therapy, or guideline-based therapy alone. Standard care included physical counterpressure maneuvers, avoidance of known triggers, increased salt and water intake, and drug therapy or pacing at the discretion of the treating physician.

The primary outcome was a composite of the number of episodes of syncope and presyncope at 12 months.    

Secondary outcomes including QoL, assessed using the World Health Organization Quality of Life Brief Field questionnaire (WHOQoL-BREF) and the Syncope Functional Status Questionnaire (SFSQ) at 12 months, a head-up tilt test, and heart rate variability at 6 weeks.

For the first 2 weeks, patients in the intervention group were enrolled in eight supervised yoga sessions conducted at the Centre for Integrative Medicine and Research at the All India Institute of Medical Sciences. For the remainder of the trial, they continued a daily yoga practice at home at least 5 days a week.

The yoga module created for participants was designed with a view to the pathophysiology of VVS and featured postures, breathing, and relaxation techniques. Yoga classes were taught by qualified therapists under the guidance of physicians.

In addition to a booklet with a pictorial of the yoga regimen, participants received twice-monthly calls from the yoga center to encourage compliance. Results show that all participants adhered to their yoga routine for more than 80% of the 12-month trial.

At 12 months, the mean number of syncopal or presyncopal events was 0.7 ± 0.7 with the yoga intervention versus 2.52 ± 1.93 among patients in the control arm (P < .05). The reduction in events started as early as 6 weeks and continued to separate out to 12 months, the researchers note.

Thirteen of 30 (43.3%) intervention patients and 4 of 25 (16%) control patients remained event-free at 12 months, a statistically significant difference (P = .02). There was a trend toward fewer positive head-up tilt tests between groups that did not reach significance, and there was no difference in heart rate variability at 6 weeks.

No adverse events as a result of the yoga practice were reported, and no patient started drug therapy or received pacing therapy during the trial, they note.

The researchers point out that yoga postures can enhance vascular and muscle tone, especially in the lower limbs.

“Yoga breathing and relaxation techniques have been shown to increase vagal tone and improve autonomic balance, which could potentially curtail the sympathetic overdrive phase and interrupt the activation of the c-mechanoreceptors, which is a critical step in the syncope cascade,” they note.

“We postulate that positive effects of yoga in this study could be related to a multidimensional effect of this intervention acting through both central and peripheral mechanisms, including physical, psychological, and autonomic pathways,” the authors conclude.
 

 

 

Comprehensive regimen

Dhanunjaya Lakkireddy, MD, medical director for the Kansas City Heart Rhythm Institute, Overland Park, Kansas, says these results are in line with previous research indicating the benefits of yoga in improving cardiovascular function.

“All of this clearly shows that when you [include] a systematic diet of yoga for a reasonable amount of time to improve the plasticity of parasympathetic inputs into the chest and thereby the cardiovascular system ... you can help patients to improve their symptoms,” he said in an interview.  

He already prescribes yoga in his own practice as part of a comprehensive therapeutic regimen, he said. “We have a handful of practitioners all around the city who work with us,” Dr. Lakkireddy said.

Both he and the study authors point the economic burden of VVS both in management and in loss of patient productivity. “A low-cost intervention in the form of yoga, which essentially requires only a mat, can reduce both direct and indirect costs significantly,” note the authors.

The trial was supported under the extramural research (EMR) scheme by the Ministry of AYUSH, Government of India. The authors have disclosed no relevant financial relationships.

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

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Yoga added to conventional therapy for vasovagal syncope (VVS), when patients faint after a sudden drop in heart rate and blood pressure, can reduce symptoms and improve quality of life, new research suggests. 

AndiP/pixabay.com

A small, open-label trial conducted in New Delhi showed that participants practicing yoga reported an improvement in VVS symptoms after only 6 weeks, with a reduction of 1.82 events at 12 months. All those practicing yoga also showed significantly improved quality of life (QoL) scores by the end of the trial.

“Yoga as add-on therapy in VVS is superior to medical therapy in reducing syncopal and presyncopal events and in improving the QoL,” report Gautam Sharma, MD, DM, Centre for Integrative Medicine and Research, All India Institute of Medical Sciences, New Delhi, and colleagues. “It may be useful to integrate a cost-effective and safe intervention such as yoga into the management of VVS.”

Results of the LIVE-Yoga study were published online in JACC: Clinical Electrophysiology.

Vasovagal syncope is a common and non–life-threatening condition, but given the severity and frequency of recurrence it can result in significant deterioration in a patient’s quality of life, the authors note. “Existing management therapies have been largely ineffective,” they write.

Recent trials have suggested some efficacy for yoga in diseases of autonomic imbalance, suggesting a possible use in VVS. To find out, the researchers enrolled adults with VVS between the ages of 15-70 years who had a positive head-up tilt test (HUTT) and at least two syncope or presyncope events within 3 months of enrollment. They also needed to be willing and able to practice yoga. Those with structural heart disease, accelerated hypertension, and underlying neurologic disorders were not included in the study.

A total of 55 patients were randomly assigned to receive either a specialized yoga training program in addition to guideline-based therapy, or guideline-based therapy alone. Standard care included physical counterpressure maneuvers, avoidance of known triggers, increased salt and water intake, and drug therapy or pacing at the discretion of the treating physician.

The primary outcome was a composite of the number of episodes of syncope and presyncope at 12 months.    

Secondary outcomes including QoL, assessed using the World Health Organization Quality of Life Brief Field questionnaire (WHOQoL-BREF) and the Syncope Functional Status Questionnaire (SFSQ) at 12 months, a head-up tilt test, and heart rate variability at 6 weeks.

For the first 2 weeks, patients in the intervention group were enrolled in eight supervised yoga sessions conducted at the Centre for Integrative Medicine and Research at the All India Institute of Medical Sciences. For the remainder of the trial, they continued a daily yoga practice at home at least 5 days a week.

The yoga module created for participants was designed with a view to the pathophysiology of VVS and featured postures, breathing, and relaxation techniques. Yoga classes were taught by qualified therapists under the guidance of physicians.

In addition to a booklet with a pictorial of the yoga regimen, participants received twice-monthly calls from the yoga center to encourage compliance. Results show that all participants adhered to their yoga routine for more than 80% of the 12-month trial.

At 12 months, the mean number of syncopal or presyncopal events was 0.7 ± 0.7 with the yoga intervention versus 2.52 ± 1.93 among patients in the control arm (P < .05). The reduction in events started as early as 6 weeks and continued to separate out to 12 months, the researchers note.

Thirteen of 30 (43.3%) intervention patients and 4 of 25 (16%) control patients remained event-free at 12 months, a statistically significant difference (P = .02). There was a trend toward fewer positive head-up tilt tests between groups that did not reach significance, and there was no difference in heart rate variability at 6 weeks.

No adverse events as a result of the yoga practice were reported, and no patient started drug therapy or received pacing therapy during the trial, they note.

The researchers point out that yoga postures can enhance vascular and muscle tone, especially in the lower limbs.

“Yoga breathing and relaxation techniques have been shown to increase vagal tone and improve autonomic balance, which could potentially curtail the sympathetic overdrive phase and interrupt the activation of the c-mechanoreceptors, which is a critical step in the syncope cascade,” they note.

“We postulate that positive effects of yoga in this study could be related to a multidimensional effect of this intervention acting through both central and peripheral mechanisms, including physical, psychological, and autonomic pathways,” the authors conclude.
 

 

 

Comprehensive regimen

Dhanunjaya Lakkireddy, MD, medical director for the Kansas City Heart Rhythm Institute, Overland Park, Kansas, says these results are in line with previous research indicating the benefits of yoga in improving cardiovascular function.

“All of this clearly shows that when you [include] a systematic diet of yoga for a reasonable amount of time to improve the plasticity of parasympathetic inputs into the chest and thereby the cardiovascular system ... you can help patients to improve their symptoms,” he said in an interview.  

He already prescribes yoga in his own practice as part of a comprehensive therapeutic regimen, he said. “We have a handful of practitioners all around the city who work with us,” Dr. Lakkireddy said.

Both he and the study authors point the economic burden of VVS both in management and in loss of patient productivity. “A low-cost intervention in the form of yoga, which essentially requires only a mat, can reduce both direct and indirect costs significantly,” note the authors.

The trial was supported under the extramural research (EMR) scheme by the Ministry of AYUSH, Government of India. The authors have disclosed no relevant financial relationships.

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

Yoga added to conventional therapy for vasovagal syncope (VVS), when patients faint after a sudden drop in heart rate and blood pressure, can reduce symptoms and improve quality of life, new research suggests. 

AndiP/pixabay.com

A small, open-label trial conducted in New Delhi showed that participants practicing yoga reported an improvement in VVS symptoms after only 6 weeks, with a reduction of 1.82 events at 12 months. All those practicing yoga also showed significantly improved quality of life (QoL) scores by the end of the trial.

“Yoga as add-on therapy in VVS is superior to medical therapy in reducing syncopal and presyncopal events and in improving the QoL,” report Gautam Sharma, MD, DM, Centre for Integrative Medicine and Research, All India Institute of Medical Sciences, New Delhi, and colleagues. “It may be useful to integrate a cost-effective and safe intervention such as yoga into the management of VVS.”

Results of the LIVE-Yoga study were published online in JACC: Clinical Electrophysiology.

Vasovagal syncope is a common and non–life-threatening condition, but given the severity and frequency of recurrence it can result in significant deterioration in a patient’s quality of life, the authors note. “Existing management therapies have been largely ineffective,” they write.

Recent trials have suggested some efficacy for yoga in diseases of autonomic imbalance, suggesting a possible use in VVS. To find out, the researchers enrolled adults with VVS between the ages of 15-70 years who had a positive head-up tilt test (HUTT) and at least two syncope or presyncope events within 3 months of enrollment. They also needed to be willing and able to practice yoga. Those with structural heart disease, accelerated hypertension, and underlying neurologic disorders were not included in the study.

A total of 55 patients were randomly assigned to receive either a specialized yoga training program in addition to guideline-based therapy, or guideline-based therapy alone. Standard care included physical counterpressure maneuvers, avoidance of known triggers, increased salt and water intake, and drug therapy or pacing at the discretion of the treating physician.

The primary outcome was a composite of the number of episodes of syncope and presyncope at 12 months.    

Secondary outcomes including QoL, assessed using the World Health Organization Quality of Life Brief Field questionnaire (WHOQoL-BREF) and the Syncope Functional Status Questionnaire (SFSQ) at 12 months, a head-up tilt test, and heart rate variability at 6 weeks.

For the first 2 weeks, patients in the intervention group were enrolled in eight supervised yoga sessions conducted at the Centre for Integrative Medicine and Research at the All India Institute of Medical Sciences. For the remainder of the trial, they continued a daily yoga practice at home at least 5 days a week.

The yoga module created for participants was designed with a view to the pathophysiology of VVS and featured postures, breathing, and relaxation techniques. Yoga classes were taught by qualified therapists under the guidance of physicians.

In addition to a booklet with a pictorial of the yoga regimen, participants received twice-monthly calls from the yoga center to encourage compliance. Results show that all participants adhered to their yoga routine for more than 80% of the 12-month trial.

At 12 months, the mean number of syncopal or presyncopal events was 0.7 ± 0.7 with the yoga intervention versus 2.52 ± 1.93 among patients in the control arm (P < .05). The reduction in events started as early as 6 weeks and continued to separate out to 12 months, the researchers note.

Thirteen of 30 (43.3%) intervention patients and 4 of 25 (16%) control patients remained event-free at 12 months, a statistically significant difference (P = .02). There was a trend toward fewer positive head-up tilt tests between groups that did not reach significance, and there was no difference in heart rate variability at 6 weeks.

No adverse events as a result of the yoga practice were reported, and no patient started drug therapy or received pacing therapy during the trial, they note.

The researchers point out that yoga postures can enhance vascular and muscle tone, especially in the lower limbs.

“Yoga breathing and relaxation techniques have been shown to increase vagal tone and improve autonomic balance, which could potentially curtail the sympathetic overdrive phase and interrupt the activation of the c-mechanoreceptors, which is a critical step in the syncope cascade,” they note.

“We postulate that positive effects of yoga in this study could be related to a multidimensional effect of this intervention acting through both central and peripheral mechanisms, including physical, psychological, and autonomic pathways,” the authors conclude.
 

 

 

Comprehensive regimen

Dhanunjaya Lakkireddy, MD, medical director for the Kansas City Heart Rhythm Institute, Overland Park, Kansas, says these results are in line with previous research indicating the benefits of yoga in improving cardiovascular function.

“All of this clearly shows that when you [include] a systematic diet of yoga for a reasonable amount of time to improve the plasticity of parasympathetic inputs into the chest and thereby the cardiovascular system ... you can help patients to improve their symptoms,” he said in an interview.  

He already prescribes yoga in his own practice as part of a comprehensive therapeutic regimen, he said. “We have a handful of practitioners all around the city who work with us,” Dr. Lakkireddy said.

Both he and the study authors point the economic burden of VVS both in management and in loss of patient productivity. “A low-cost intervention in the form of yoga, which essentially requires only a mat, can reduce both direct and indirect costs significantly,” note the authors.

The trial was supported under the extramural research (EMR) scheme by the Ministry of AYUSH, Government of India. The authors have disclosed no relevant financial relationships.

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

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Editor’s Note: Looking forward

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The Rare Diseases Report: Cancers supplement looks to the future from trial design to treatment for some of the most underserved diseases and patient populations.

In this special report we bring you the latest information on new and ongoing developments in the treatment of a number of cancer types through interviews with leaders in the field. And in this unique time of COVID-19 disease, we provide an update on the effects of the pandemic on immune system issues in this highly vulnerable population of cancer patients. In addition, we feature some of the critical issues of dealing with racial, ethnic, sex, and gender disparities among others in these unique populations. We hope you enjoy the issue.

– Mark S. Lesney, PhD
   Editor

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The Rare Diseases Report: Cancers supplement looks to the future from trial design to treatment for some of the most underserved diseases and patient populations.

In this special report we bring you the latest information on new and ongoing developments in the treatment of a number of cancer types through interviews with leaders in the field. And in this unique time of COVID-19 disease, we provide an update on the effects of the pandemic on immune system issues in this highly vulnerable population of cancer patients. In addition, we feature some of the critical issues of dealing with racial, ethnic, sex, and gender disparities among others in these unique populations. We hope you enjoy the issue.

– Mark S. Lesney, PhD
   Editor

The Rare Diseases Report: Cancers supplement looks to the future from trial design to treatment for some of the most underserved diseases and patient populations.

In this special report we bring you the latest information on new and ongoing developments in the treatment of a number of cancer types through interviews with leaders in the field. And in this unique time of COVID-19 disease, we provide an update on the effects of the pandemic on immune system issues in this highly vulnerable population of cancer patients. In addition, we feature some of the critical issues of dealing with racial, ethnic, sex, and gender disparities among others in these unique populations. We hope you enjoy the issue.

– Mark S. Lesney, PhD
   Editor

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The Angel of Death in Clarksburg

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Readers of this column may recall that since I have been the Editor-in-Chief of Federal Practitioner, my December editorial focuses on the best and worst of the year in federal medicine. In 2021, these evaluative terms fail to capture the sadness and global devastation that mark this grim epoch of the continuing pandemic, increasing climate disasters, rising political tensions, and racial violence. Thus, this year my editorial is framed in terms of the philosophical or theological categories of good and evil as the only concepts that can even begin to express the horrendous events that occurred in West Virginia.

On June 28, 2018, then US Department of Veterans Affairs (VA) Veterans Health Administration (VHA) Executive-in-Charge, Carolyn Clancy, MD, contacted Inspector General Michael Missal to alert him that “there may be an ‘Angel of Death’ in Clarksburg [West Virginia].”1 Two years later Reta Mays, a 46-year-old VA nursing assistant, entered a guilty plea in federal court to the deaths of 7 vulnerable veterans. The legal charges were second-degree murder and 1 count of assault with intent to commit murder by injecting insulin. The victims were all patients on Ward 3 at the Louis A. Johnson VA, Medical Center in Clarksburg, where Mays worked the night shift from 2015 to 2018.2 Mays was sentenced in May of this year to 7 consecutive life terms for each of the veterans whose lives she cruelly ended and an additional 240 months for the eighth patient who survived her murder attempt.3

The term angel of death has religious roots in Judaism, although not strictly in the Hebrew scriptures. Neither the Jewish nor Christian Bible identifies a specific figure who is the angel of death. The idea first appears in Rabbinic literature and Jewish tradition.4 The angel God sends as a messenger of death is known as malakh ha-mavet in Hebrew. The revered Jewish physician and philosopher Moses Maimonides taught in his Guide for the Perplexed the angel of death is synonymous with the devil, and the evil inclination that dwells in the mind of all human beings.5In modern times, the concept of an angel of death has come to designate a serial killer who is a health care professional (HCP). A group of forensic scientists, HCPs, and attorneys, including former VA Under Secretary for Health Dr. Kenneth Kizer, published a study of HCPs who had been prosecuted or convicted of serial murder. Nurses constituted the largest group of offenders (60%) with nursing aides like Mays responsible for 18% of murders, and physicians 12%. The review found that though health care serial killers are rare, they operate in nations across the Western world, in many different states in this country, and in almost all health care settings, including previous VA angels of death.6Nursing aides who are not supposed to have access to medications—a major problem in Mays’ case—nor permitted to administer them more often resort to noncontrolled substances to kill their victims.1 Mays chose insulin as her murder weapon as did 13% of serial killers. Just as insulin may be difficult to detect in toxicology, so Mays and others like her committed their crimes on the night shift when they were less likely to be discovered.6

Many of us feel compelled to seek a rational motivation for why healers would mutate into killers: If we can find a reason for this heinous behavior it somehow helps us feel the world is more intelligible and controllable. Unfortunately, despite intensive forensic investigations of multiple angels of death, there is little definitive understanding of the motives of these murders.6 Mays disclosed more than most. As part of a plea bargain, she provided investigators with 2 rationales for her killing: She wanted to ease the patients’ suffering. Such claims of being an angel of mercy are common among HCP serial murders, which the patterns of the killings generally disprove. The patients Mays lethally injected, while mostly old and ill, were all expected to recover and leave the hospital. The Inspector General report uncovered a cautionary detail that has at least indirect bearing on the nursing assistant’s contention that she “wanted to let the patient’s die gently”: Contrary to VHA requirements, the facility had no functioning palliative care team. This finding in no way excuses or even explains Mays’ actions; it does, however, reinforce the essential value of palliative care expertise in an aging veteran population with many life-limiting conditions.7

Mays’ second motivation seems more plausible, based on her life narrative and the literature on HCP serial killers. Mays disclosed to investigators that she “had a lot of stress and chaos in [her] personal and professional life and these actions gave [her] a sense of control.”1 Her prior use of excessive force when employed at a prison as well as forensic science indicating that feelings of wielding power over life and death often drive health care murders, suggest this may have been a factor in Mays’ horrific conduct.8

It seems blasphemous to associate the word good in the same pages with this terrible evil. Nothing can compensate or justify the betrayal of the sacred oath of an HCP and the public trust of a VHA employee. Yet that very impossibility carries with it an obligation to ask, as did the author of an article about a recent Canadian nurse serial killer, “What can we learn from the [Mays] story?”9

Mays could never have taken the lives of 8 patients without clinical and administrative lapses and shortcuts at all levels of the health care system. Indeed, the 100-plus page Inspector General report makes 15 recommendations for the VHA, the Veterans Integrated Service Network, and the facility, encompassing areas of personnel hiring and performance evaluation, medication management and security, reporting and responding to unexplained events, quality and safety programs oversight, leaders’ responses, corrective actions, and even computer systems data analysis.

I want to suggest 2 ethical additions to this list addressed to all of us as VHA staff and especially to those of us who are HCPs. From the perspective of virtue ethics, Reta Mays is a tragedy about complacency and compromise in everyday work that the pandemic has made even more frequent and challenging to avoid and resist. This is what the Roman Virgil means in the epigraph that the road down to hell is easy and the road back very difficult.

I propose the need for discernment in trying to listen to our moral intuitions that tell us something is amiss and diligence in adhering to best practices even when we are fearful, exhausted, demoralized, or apathetic. These 2 habits of commitment to veterans, one of compassion and the other of competence, can help us follow the good inclinations of our hearts and together with system changes can bar the doors of our hospitals to the visits of future angels of death. This dedication is the least we owe to the families of the patients at Clarksburg whose loved ones never came home and whose questions likely can never be fully answered.

References

1. US Department of Veterans Affairs, Office of Inspector General. Veterans Health Administration: care and oversight deficiencies related to multiple homicides at the Louis A. Johnson VA Medical Center in Clarksburg, West Virginia. Healthcare Inspection Report #20-035993-140. Published May 11 2021. Accessed November 22, 2021. https://www.va.gov/oig/pubs/VAOIG-20-03593-140.pdf

2. Kennedy M, Schwartz M. Former VA medical worker pleads guilty to murdering 7 patients in West Virginia. Published July 14, 2020. Accessed November 22, 2021. https://www.npr.org/2020/07/14/890776010/former-va-medical-worker-charged-with-7-murders-in-west-virginia

3. US Department of Justice, US Attorney’s Office Northern District of West Virginia. Former VA hospital nursing assistant sentenced to seven consecutive life sentences for murdering seven veterans and assault with intent to commit murder of an eighth [press release]. Published May 11, 2021. Accessed November 22, 2021. https://www.justice.gov/usao-ndwv/pr/former-va-hospital-nursing-assistant-sentenced-seven-consecutive-life-sentences.

4. Jacobs L. The Jewish Religion: A Companion. 1st ed. Oxford University Press;1995:116.

5. Maimonides. Guide for the Perplexed. Frielander M, trans. Routledge and Kegan Paul Ltd; 1904:pt 3, chap 22.

6. Yorker BC, Kizer KW, Lampe P, Forrest AR, Lannan JM, Russell DA. Serial murder by healthcare professionals. J Forensic Sci. 2006;51(6):1362-1371. doi:10.1111/j.1556-4029.2006.00273.x

7. VHA Directive 1139. Palliative care consult teams (PCCT) and VISN leads. Published June 14, 2017.

8. Rourke S, Ward T. Healthcare serial killers: patterns and policies. Published August 14, 2017. Accessed November 22, 2021. https://www.medscape.com/viewarticle/884136

9. Frank C. Health care serial murder: what can we learn from the Wettlaufer story? Can Fam Physician. 2020;66(10):719-722.

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Readers of this column may recall that since I have been the Editor-in-Chief of Federal Practitioner, my December editorial focuses on the best and worst of the year in federal medicine. In 2021, these evaluative terms fail to capture the sadness and global devastation that mark this grim epoch of the continuing pandemic, increasing climate disasters, rising political tensions, and racial violence. Thus, this year my editorial is framed in terms of the philosophical or theological categories of good and evil as the only concepts that can even begin to express the horrendous events that occurred in West Virginia.

On June 28, 2018, then US Department of Veterans Affairs (VA) Veterans Health Administration (VHA) Executive-in-Charge, Carolyn Clancy, MD, contacted Inspector General Michael Missal to alert him that “there may be an ‘Angel of Death’ in Clarksburg [West Virginia].”1 Two years later Reta Mays, a 46-year-old VA nursing assistant, entered a guilty plea in federal court to the deaths of 7 vulnerable veterans. The legal charges were second-degree murder and 1 count of assault with intent to commit murder by injecting insulin. The victims were all patients on Ward 3 at the Louis A. Johnson VA, Medical Center in Clarksburg, where Mays worked the night shift from 2015 to 2018.2 Mays was sentenced in May of this year to 7 consecutive life terms for each of the veterans whose lives she cruelly ended and an additional 240 months for the eighth patient who survived her murder attempt.3

The term angel of death has religious roots in Judaism, although not strictly in the Hebrew scriptures. Neither the Jewish nor Christian Bible identifies a specific figure who is the angel of death. The idea first appears in Rabbinic literature and Jewish tradition.4 The angel God sends as a messenger of death is known as malakh ha-mavet in Hebrew. The revered Jewish physician and philosopher Moses Maimonides taught in his Guide for the Perplexed the angel of death is synonymous with the devil, and the evil inclination that dwells in the mind of all human beings.5In modern times, the concept of an angel of death has come to designate a serial killer who is a health care professional (HCP). A group of forensic scientists, HCPs, and attorneys, including former VA Under Secretary for Health Dr. Kenneth Kizer, published a study of HCPs who had been prosecuted or convicted of serial murder. Nurses constituted the largest group of offenders (60%) with nursing aides like Mays responsible for 18% of murders, and physicians 12%. The review found that though health care serial killers are rare, they operate in nations across the Western world, in many different states in this country, and in almost all health care settings, including previous VA angels of death.6Nursing aides who are not supposed to have access to medications—a major problem in Mays’ case—nor permitted to administer them more often resort to noncontrolled substances to kill their victims.1 Mays chose insulin as her murder weapon as did 13% of serial killers. Just as insulin may be difficult to detect in toxicology, so Mays and others like her committed their crimes on the night shift when they were less likely to be discovered.6

Many of us feel compelled to seek a rational motivation for why healers would mutate into killers: If we can find a reason for this heinous behavior it somehow helps us feel the world is more intelligible and controllable. Unfortunately, despite intensive forensic investigations of multiple angels of death, there is little definitive understanding of the motives of these murders.6 Mays disclosed more than most. As part of a plea bargain, she provided investigators with 2 rationales for her killing: She wanted to ease the patients’ suffering. Such claims of being an angel of mercy are common among HCP serial murders, which the patterns of the killings generally disprove. The patients Mays lethally injected, while mostly old and ill, were all expected to recover and leave the hospital. The Inspector General report uncovered a cautionary detail that has at least indirect bearing on the nursing assistant’s contention that she “wanted to let the patient’s die gently”: Contrary to VHA requirements, the facility had no functioning palliative care team. This finding in no way excuses or even explains Mays’ actions; it does, however, reinforce the essential value of palliative care expertise in an aging veteran population with many life-limiting conditions.7

Mays’ second motivation seems more plausible, based on her life narrative and the literature on HCP serial killers. Mays disclosed to investigators that she “had a lot of stress and chaos in [her] personal and professional life and these actions gave [her] a sense of control.”1 Her prior use of excessive force when employed at a prison as well as forensic science indicating that feelings of wielding power over life and death often drive health care murders, suggest this may have been a factor in Mays’ horrific conduct.8

It seems blasphemous to associate the word good in the same pages with this terrible evil. Nothing can compensate or justify the betrayal of the sacred oath of an HCP and the public trust of a VHA employee. Yet that very impossibility carries with it an obligation to ask, as did the author of an article about a recent Canadian nurse serial killer, “What can we learn from the [Mays] story?”9

Mays could never have taken the lives of 8 patients without clinical and administrative lapses and shortcuts at all levels of the health care system. Indeed, the 100-plus page Inspector General report makes 15 recommendations for the VHA, the Veterans Integrated Service Network, and the facility, encompassing areas of personnel hiring and performance evaluation, medication management and security, reporting and responding to unexplained events, quality and safety programs oversight, leaders’ responses, corrective actions, and even computer systems data analysis.

I want to suggest 2 ethical additions to this list addressed to all of us as VHA staff and especially to those of us who are HCPs. From the perspective of virtue ethics, Reta Mays is a tragedy about complacency and compromise in everyday work that the pandemic has made even more frequent and challenging to avoid and resist. This is what the Roman Virgil means in the epigraph that the road down to hell is easy and the road back very difficult.

I propose the need for discernment in trying to listen to our moral intuitions that tell us something is amiss and diligence in adhering to best practices even when we are fearful, exhausted, demoralized, or apathetic. These 2 habits of commitment to veterans, one of compassion and the other of competence, can help us follow the good inclinations of our hearts and together with system changes can bar the doors of our hospitals to the visits of future angels of death. This dedication is the least we owe to the families of the patients at Clarksburg whose loved ones never came home and whose questions likely can never be fully answered.

Readers of this column may recall that since I have been the Editor-in-Chief of Federal Practitioner, my December editorial focuses on the best and worst of the year in federal medicine. In 2021, these evaluative terms fail to capture the sadness and global devastation that mark this grim epoch of the continuing pandemic, increasing climate disasters, rising political tensions, and racial violence. Thus, this year my editorial is framed in terms of the philosophical or theological categories of good and evil as the only concepts that can even begin to express the horrendous events that occurred in West Virginia.

On June 28, 2018, then US Department of Veterans Affairs (VA) Veterans Health Administration (VHA) Executive-in-Charge, Carolyn Clancy, MD, contacted Inspector General Michael Missal to alert him that “there may be an ‘Angel of Death’ in Clarksburg [West Virginia].”1 Two years later Reta Mays, a 46-year-old VA nursing assistant, entered a guilty plea in federal court to the deaths of 7 vulnerable veterans. The legal charges were second-degree murder and 1 count of assault with intent to commit murder by injecting insulin. The victims were all patients on Ward 3 at the Louis A. Johnson VA, Medical Center in Clarksburg, where Mays worked the night shift from 2015 to 2018.2 Mays was sentenced in May of this year to 7 consecutive life terms for each of the veterans whose lives she cruelly ended and an additional 240 months for the eighth patient who survived her murder attempt.3

The term angel of death has religious roots in Judaism, although not strictly in the Hebrew scriptures. Neither the Jewish nor Christian Bible identifies a specific figure who is the angel of death. The idea first appears in Rabbinic literature and Jewish tradition.4 The angel God sends as a messenger of death is known as malakh ha-mavet in Hebrew. The revered Jewish physician and philosopher Moses Maimonides taught in his Guide for the Perplexed the angel of death is synonymous with the devil, and the evil inclination that dwells in the mind of all human beings.5In modern times, the concept of an angel of death has come to designate a serial killer who is a health care professional (HCP). A group of forensic scientists, HCPs, and attorneys, including former VA Under Secretary for Health Dr. Kenneth Kizer, published a study of HCPs who had been prosecuted or convicted of serial murder. Nurses constituted the largest group of offenders (60%) with nursing aides like Mays responsible for 18% of murders, and physicians 12%. The review found that though health care serial killers are rare, they operate in nations across the Western world, in many different states in this country, and in almost all health care settings, including previous VA angels of death.6Nursing aides who are not supposed to have access to medications—a major problem in Mays’ case—nor permitted to administer them more often resort to noncontrolled substances to kill their victims.1 Mays chose insulin as her murder weapon as did 13% of serial killers. Just as insulin may be difficult to detect in toxicology, so Mays and others like her committed their crimes on the night shift when they were less likely to be discovered.6

Many of us feel compelled to seek a rational motivation for why healers would mutate into killers: If we can find a reason for this heinous behavior it somehow helps us feel the world is more intelligible and controllable. Unfortunately, despite intensive forensic investigations of multiple angels of death, there is little definitive understanding of the motives of these murders.6 Mays disclosed more than most. As part of a plea bargain, she provided investigators with 2 rationales for her killing: She wanted to ease the patients’ suffering. Such claims of being an angel of mercy are common among HCP serial murders, which the patterns of the killings generally disprove. The patients Mays lethally injected, while mostly old and ill, were all expected to recover and leave the hospital. The Inspector General report uncovered a cautionary detail that has at least indirect bearing on the nursing assistant’s contention that she “wanted to let the patient’s die gently”: Contrary to VHA requirements, the facility had no functioning palliative care team. This finding in no way excuses or even explains Mays’ actions; it does, however, reinforce the essential value of palliative care expertise in an aging veteran population with many life-limiting conditions.7

Mays’ second motivation seems more plausible, based on her life narrative and the literature on HCP serial killers. Mays disclosed to investigators that she “had a lot of stress and chaos in [her] personal and professional life and these actions gave [her] a sense of control.”1 Her prior use of excessive force when employed at a prison as well as forensic science indicating that feelings of wielding power over life and death often drive health care murders, suggest this may have been a factor in Mays’ horrific conduct.8

It seems blasphemous to associate the word good in the same pages with this terrible evil. Nothing can compensate or justify the betrayal of the sacred oath of an HCP and the public trust of a VHA employee. Yet that very impossibility carries with it an obligation to ask, as did the author of an article about a recent Canadian nurse serial killer, “What can we learn from the [Mays] story?”9

Mays could never have taken the lives of 8 patients without clinical and administrative lapses and shortcuts at all levels of the health care system. Indeed, the 100-plus page Inspector General report makes 15 recommendations for the VHA, the Veterans Integrated Service Network, and the facility, encompassing areas of personnel hiring and performance evaluation, medication management and security, reporting and responding to unexplained events, quality and safety programs oversight, leaders’ responses, corrective actions, and even computer systems data analysis.

I want to suggest 2 ethical additions to this list addressed to all of us as VHA staff and especially to those of us who are HCPs. From the perspective of virtue ethics, Reta Mays is a tragedy about complacency and compromise in everyday work that the pandemic has made even more frequent and challenging to avoid and resist. This is what the Roman Virgil means in the epigraph that the road down to hell is easy and the road back very difficult.

I propose the need for discernment in trying to listen to our moral intuitions that tell us something is amiss and diligence in adhering to best practices even when we are fearful, exhausted, demoralized, or apathetic. These 2 habits of commitment to veterans, one of compassion and the other of competence, can help us follow the good inclinations of our hearts and together with system changes can bar the doors of our hospitals to the visits of future angels of death. This dedication is the least we owe to the families of the patients at Clarksburg whose loved ones never came home and whose questions likely can never be fully answered.

References

1. US Department of Veterans Affairs, Office of Inspector General. Veterans Health Administration: care and oversight deficiencies related to multiple homicides at the Louis A. Johnson VA Medical Center in Clarksburg, West Virginia. Healthcare Inspection Report #20-035993-140. Published May 11 2021. Accessed November 22, 2021. https://www.va.gov/oig/pubs/VAOIG-20-03593-140.pdf

2. Kennedy M, Schwartz M. Former VA medical worker pleads guilty to murdering 7 patients in West Virginia. Published July 14, 2020. Accessed November 22, 2021. https://www.npr.org/2020/07/14/890776010/former-va-medical-worker-charged-with-7-murders-in-west-virginia

3. US Department of Justice, US Attorney’s Office Northern District of West Virginia. Former VA hospital nursing assistant sentenced to seven consecutive life sentences for murdering seven veterans and assault with intent to commit murder of an eighth [press release]. Published May 11, 2021. Accessed November 22, 2021. https://www.justice.gov/usao-ndwv/pr/former-va-hospital-nursing-assistant-sentenced-seven-consecutive-life-sentences.

4. Jacobs L. The Jewish Religion: A Companion. 1st ed. Oxford University Press;1995:116.

5. Maimonides. Guide for the Perplexed. Frielander M, trans. Routledge and Kegan Paul Ltd; 1904:pt 3, chap 22.

6. Yorker BC, Kizer KW, Lampe P, Forrest AR, Lannan JM, Russell DA. Serial murder by healthcare professionals. J Forensic Sci. 2006;51(6):1362-1371. doi:10.1111/j.1556-4029.2006.00273.x

7. VHA Directive 1139. Palliative care consult teams (PCCT) and VISN leads. Published June 14, 2017.

8. Rourke S, Ward T. Healthcare serial killers: patterns and policies. Published August 14, 2017. Accessed November 22, 2021. https://www.medscape.com/viewarticle/884136

9. Frank C. Health care serial murder: what can we learn from the Wettlaufer story? Can Fam Physician. 2020;66(10):719-722.

References

1. US Department of Veterans Affairs, Office of Inspector General. Veterans Health Administration: care and oversight deficiencies related to multiple homicides at the Louis A. Johnson VA Medical Center in Clarksburg, West Virginia. Healthcare Inspection Report #20-035993-140. Published May 11 2021. Accessed November 22, 2021. https://www.va.gov/oig/pubs/VAOIG-20-03593-140.pdf

2. Kennedy M, Schwartz M. Former VA medical worker pleads guilty to murdering 7 patients in West Virginia. Published July 14, 2020. Accessed November 22, 2021. https://www.npr.org/2020/07/14/890776010/former-va-medical-worker-charged-with-7-murders-in-west-virginia

3. US Department of Justice, US Attorney’s Office Northern District of West Virginia. Former VA hospital nursing assistant sentenced to seven consecutive life sentences for murdering seven veterans and assault with intent to commit murder of an eighth [press release]. Published May 11, 2021. Accessed November 22, 2021. https://www.justice.gov/usao-ndwv/pr/former-va-hospital-nursing-assistant-sentenced-seven-consecutive-life-sentences.

4. Jacobs L. The Jewish Religion: A Companion. 1st ed. Oxford University Press;1995:116.

5. Maimonides. Guide for the Perplexed. Frielander M, trans. Routledge and Kegan Paul Ltd; 1904:pt 3, chap 22.

6. Yorker BC, Kizer KW, Lampe P, Forrest AR, Lannan JM, Russell DA. Serial murder by healthcare professionals. J Forensic Sci. 2006;51(6):1362-1371. doi:10.1111/j.1556-4029.2006.00273.x

7. VHA Directive 1139. Palliative care consult teams (PCCT) and VISN leads. Published June 14, 2017.

8. Rourke S, Ward T. Healthcare serial killers: patterns and policies. Published August 14, 2017. Accessed November 22, 2021. https://www.medscape.com/viewarticle/884136

9. Frank C. Health care serial murder: what can we learn from the Wettlaufer story? Can Fam Physician. 2020;66(10):719-722.

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AMA, hospital group sue federal government over surprise billing law

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Hospital and physician groups on Dec. 9 announced their plan to sue the federal government over its plan for addressing disputes about surprise medical bills, which tilts toward using prevailing rates paid for services.

The American Hospital Association and American Medical Association said they will ask the U.S. District Court for the District of Columbia to try to prevent implementation of certain provisions of new federal rules on surprise bills. This court is often a venue for fights over federal rules. Also joining the suit are Nevada-based Renown Health, UMass Memorial Health, and two physicians based in North Carolina, AHA and AMA said.

Federal agencies, including the Department of Health & Human Services, in September had unveiled the rule on surprise medical bills that will take effect Jan. 1.

Under this rule, a key benchmark for payment disputes would be the qualifying payment amount (QPA), which is pegged to median contracted rates. In the dispute-resolution process outlined in the rule, there is a presumption that the QPA is the appropriate out-of-network rate.

The rule allows for exceptions in which the independent mediating organization handling the payment dispute resolution has “credible information” as to why the QPA is materially different from the appropriate out-of-network rate.

In the view of the federal agencies that issued the rule, this approach “encourages predictable outcomes,” which likely would reduce the number of disputes that go through the resolution process while also “providing equitable and clear standards” for cases to appropriately deviate from QPA. HHS was joined in issuing the rule by the Treasury and Labor Departments and the Office of Personnel Management.

AMA and AHA disagree with their view, seeing this approach as a boon for insurers at the expense of physicians and hospitals.

In a press release, they said the rule’s approach to surprise billing would “all but ensure that hospitals, physicians, and other providers will routinely be undercompensated by commercial insurers, and patients will have fewer choices for access to in-network services.”

The rule is part of the implementation of a federal law passed in December 2020, known as the No Surprises Act. In their statement, AHA and AMA said their legal challenge would not prevent “core patient protections’’ of that law from moving forward.

“No patient should fear receiving a surprise medical bill,” Rick Pollack, AHA president and chief executive, said in the statement. “That is why hospitals and health systems supported the No Surprises Act to protect patients and keep them out of the middle of disputes between providers and insurers. Congress carefully crafted the law with a balanced, patient-friendly approach and it should be implemented as intended.”

AMA President Gerald E. Harmon, MD, added the approach used in the rule on surprise billing could create “an unsustainable situation for physicians.”

“Our legal challenge urges regulators to ensure there is a fair and meaningful process to resolve disputes between health care providers and insurance companies,” Dr. Harmon said.

AHA and AMA included with their statement a link to a November letter from more than 150 members of Congress, who also objected to the approach taken in designing the independent dispute-resolution (IDR) process.

“This directive establishes a de facto benchmark rate, making the median in-network rate the default factor considered in the IDR process. This approach is contrary to statute and could incentivize insurance companies to set artificially low payment rates, which would narrow provider networks and jeopardize patient access to care – the exact opposite of the goal of the law,” wrote the members of Congress, including Rep. Raul Ruiz, MD, a California Democrat, and Rep. Larry Bucshon, MD, an Indiana Republican.

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

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Hospital and physician groups on Dec. 9 announced their plan to sue the federal government over its plan for addressing disputes about surprise medical bills, which tilts toward using prevailing rates paid for services.

The American Hospital Association and American Medical Association said they will ask the U.S. District Court for the District of Columbia to try to prevent implementation of certain provisions of new federal rules on surprise bills. This court is often a venue for fights over federal rules. Also joining the suit are Nevada-based Renown Health, UMass Memorial Health, and two physicians based in North Carolina, AHA and AMA said.

Federal agencies, including the Department of Health & Human Services, in September had unveiled the rule on surprise medical bills that will take effect Jan. 1.

Under this rule, a key benchmark for payment disputes would be the qualifying payment amount (QPA), which is pegged to median contracted rates. In the dispute-resolution process outlined in the rule, there is a presumption that the QPA is the appropriate out-of-network rate.

The rule allows for exceptions in which the independent mediating organization handling the payment dispute resolution has “credible information” as to why the QPA is materially different from the appropriate out-of-network rate.

In the view of the federal agencies that issued the rule, this approach “encourages predictable outcomes,” which likely would reduce the number of disputes that go through the resolution process while also “providing equitable and clear standards” for cases to appropriately deviate from QPA. HHS was joined in issuing the rule by the Treasury and Labor Departments and the Office of Personnel Management.

AMA and AHA disagree with their view, seeing this approach as a boon for insurers at the expense of physicians and hospitals.

In a press release, they said the rule’s approach to surprise billing would “all but ensure that hospitals, physicians, and other providers will routinely be undercompensated by commercial insurers, and patients will have fewer choices for access to in-network services.”

The rule is part of the implementation of a federal law passed in December 2020, known as the No Surprises Act. In their statement, AHA and AMA said their legal challenge would not prevent “core patient protections’’ of that law from moving forward.

“No patient should fear receiving a surprise medical bill,” Rick Pollack, AHA president and chief executive, said in the statement. “That is why hospitals and health systems supported the No Surprises Act to protect patients and keep them out of the middle of disputes between providers and insurers. Congress carefully crafted the law with a balanced, patient-friendly approach and it should be implemented as intended.”

AMA President Gerald E. Harmon, MD, added the approach used in the rule on surprise billing could create “an unsustainable situation for physicians.”

“Our legal challenge urges regulators to ensure there is a fair and meaningful process to resolve disputes between health care providers and insurance companies,” Dr. Harmon said.

AHA and AMA included with their statement a link to a November letter from more than 150 members of Congress, who also objected to the approach taken in designing the independent dispute-resolution (IDR) process.

“This directive establishes a de facto benchmark rate, making the median in-network rate the default factor considered in the IDR process. This approach is contrary to statute and could incentivize insurance companies to set artificially low payment rates, which would narrow provider networks and jeopardize patient access to care – the exact opposite of the goal of the law,” wrote the members of Congress, including Rep. Raul Ruiz, MD, a California Democrat, and Rep. Larry Bucshon, MD, an Indiana Republican.

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

 

Hospital and physician groups on Dec. 9 announced their plan to sue the federal government over its plan for addressing disputes about surprise medical bills, which tilts toward using prevailing rates paid for services.

The American Hospital Association and American Medical Association said they will ask the U.S. District Court for the District of Columbia to try to prevent implementation of certain provisions of new federal rules on surprise bills. This court is often a venue for fights over federal rules. Also joining the suit are Nevada-based Renown Health, UMass Memorial Health, and two physicians based in North Carolina, AHA and AMA said.

Federal agencies, including the Department of Health & Human Services, in September had unveiled the rule on surprise medical bills that will take effect Jan. 1.

Under this rule, a key benchmark for payment disputes would be the qualifying payment amount (QPA), which is pegged to median contracted rates. In the dispute-resolution process outlined in the rule, there is a presumption that the QPA is the appropriate out-of-network rate.

The rule allows for exceptions in which the independent mediating organization handling the payment dispute resolution has “credible information” as to why the QPA is materially different from the appropriate out-of-network rate.

In the view of the federal agencies that issued the rule, this approach “encourages predictable outcomes,” which likely would reduce the number of disputes that go through the resolution process while also “providing equitable and clear standards” for cases to appropriately deviate from QPA. HHS was joined in issuing the rule by the Treasury and Labor Departments and the Office of Personnel Management.

AMA and AHA disagree with their view, seeing this approach as a boon for insurers at the expense of physicians and hospitals.

In a press release, they said the rule’s approach to surprise billing would “all but ensure that hospitals, physicians, and other providers will routinely be undercompensated by commercial insurers, and patients will have fewer choices for access to in-network services.”

The rule is part of the implementation of a federal law passed in December 2020, known as the No Surprises Act. In their statement, AHA and AMA said their legal challenge would not prevent “core patient protections’’ of that law from moving forward.

“No patient should fear receiving a surprise medical bill,” Rick Pollack, AHA president and chief executive, said in the statement. “That is why hospitals and health systems supported the No Surprises Act to protect patients and keep them out of the middle of disputes between providers and insurers. Congress carefully crafted the law with a balanced, patient-friendly approach and it should be implemented as intended.”

AMA President Gerald E. Harmon, MD, added the approach used in the rule on surprise billing could create “an unsustainable situation for physicians.”

“Our legal challenge urges regulators to ensure there is a fair and meaningful process to resolve disputes between health care providers and insurance companies,” Dr. Harmon said.

AHA and AMA included with their statement a link to a November letter from more than 150 members of Congress, who also objected to the approach taken in designing the independent dispute-resolution (IDR) process.

“This directive establishes a de facto benchmark rate, making the median in-network rate the default factor considered in the IDR process. This approach is contrary to statute and could incentivize insurance companies to set artificially low payment rates, which would narrow provider networks and jeopardize patient access to care – the exact opposite of the goal of the law,” wrote the members of Congress, including Rep. Raul Ruiz, MD, a California Democrat, and Rep. Larry Bucshon, MD, an Indiana Republican.

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

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TikTok trends: Do or diet, plan ‘c,' garlic where?

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The year is rapidly approaching an end, and with it, we can perhaps look forward to better and brighter days in 2022. With daylight savings, seasonal depression, and cold and flu season making a comeback as temperatures across the Northern Hemisphere drop, some strange remedies have been appearing on TikTok – as they often do.

The good: doctor reveals the truth about dieting

Chisom Ikeji, MD, is a critical care clinical fellow at the University of Pittsburgh Medical Center and on TikTok under the username @drchizmd. In a TikTok with almost 200,000 views and over 18,000 likes, Dr. Ikeji explains to all New Year’s resolution-makers that dieting isn’t all it’s cracked up to be. “Dieting leads to perpetually losing weight and gaining weight on a cycle,” she says, “so that your body never really settles at its set point weight.”

Celebrities and your friends who drink lemon water in the morning may tout all sorts of fad diets and some of them might even work. But Dr. Ikeji explains that diets with gimmicks don’t have lasting power and create cycles of losing and gaining weight. Additionally, associating “points” with foods, or separating them into “good” or “bad” categories, encourages habits that can lead to disordered eating.

The best way to keep weight off is to make actual lifestyle changes that stick. In contrast, going back to dieting every year (the rapid cycle of losing and gaining weight is called  “yo-yo” dieting) can have a bad impact on your health, including increased risk of heart disease and metabolism issues.

“The best thing you can do for your body, and to help you lose weight, is to stop dieting,” Dr. Ikeji says. “Incorporate whole foods into your diet and make sure you move your body. If you don’t, you’ll be chasing that diet into your 80s and feeling guilty over a piece of cake forever. That’s no way to live life.”
 

The bad: vitamin C contraceptive

In this TikTok, user @itsdiosa reveals her contraception hack for anyone with a uterus who may be having unprotected sex. She claims that for those who forget to take the Plan B pill, vitamin C is a worthwhile substitute in preventing unwanted pregnancy. She recommends taking four or five vitamin C tablets a day for a few days for the return of a normal period.

Not surprisingly, Vitamin C isn’t safe or reliable and doesn’t have studies to back up @itsdiosa’s claim. If anything, all you’ll get from taking too much vitamin C is diarrhea and a stomachache.

Karan Rajan, MBBS, from Imperial College London and the University of Sunderland in the United Kingdom, responded to the TikTok to confirm that this claim isn’t backed up by science.

“Vitamin C doesn’t start or stop a period. Period,” he commented on the video.
 

The ugly: garlic sinus decongestant

Now this one went viral one went viral with over 5.2 million likes. In this TikTok, @hwannah5 and her boyfriend try out a trend that involves putting a clove of peeled garlic in each nostril in order to clear up congestion. The bubbles of ooey gooey snot coming out of her boyfriend’s nose certainly make it seem like it’s working, but what’s really going on?

 

 

This is hardly new; people have been putting strange things in nasal rinses for some time now and garlic is a tried-and-true favorite. Garlic does have some medically valid uses. These studies have shown that garlic taken orally may improve insulin in people with diabetes, slightly lower cholesterol, and reduce blood pressure in people with hypertension. When it comes to home remedies, people have historically used garlic as an antiseptic, antibacterial, and antifungal agent, though these claims are not widely supported by research. But taking a garlic supplement and sticking raw garlic up your nose are two very different things.

New York-based board-certified dermatologist Whitney Bowe, MD, weighed in on the viral trend.

In her own reaction video, she explained: “Guys, this is actually not safe. What’s happening is the garlic is actually triggering something called contact dermatitis and the mucosa is trying to protect itself by secreting tons of mucus. It’s creating swelling.”

For those tempted by this smelly “remedy,” a few drops of essential oil in a steamy shower is a much more pleasant (and significantly less gross) way to treat congestion.

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

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Topics
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The year is rapidly approaching an end, and with it, we can perhaps look forward to better and brighter days in 2022. With daylight savings, seasonal depression, and cold and flu season making a comeback as temperatures across the Northern Hemisphere drop, some strange remedies have been appearing on TikTok – as they often do.

The good: doctor reveals the truth about dieting

Chisom Ikeji, MD, is a critical care clinical fellow at the University of Pittsburgh Medical Center and on TikTok under the username @drchizmd. In a TikTok with almost 200,000 views and over 18,000 likes, Dr. Ikeji explains to all New Year’s resolution-makers that dieting isn’t all it’s cracked up to be. “Dieting leads to perpetually losing weight and gaining weight on a cycle,” she says, “so that your body never really settles at its set point weight.”

Celebrities and your friends who drink lemon water in the morning may tout all sorts of fad diets and some of them might even work. But Dr. Ikeji explains that diets with gimmicks don’t have lasting power and create cycles of losing and gaining weight. Additionally, associating “points” with foods, or separating them into “good” or “bad” categories, encourages habits that can lead to disordered eating.

The best way to keep weight off is to make actual lifestyle changes that stick. In contrast, going back to dieting every year (the rapid cycle of losing and gaining weight is called  “yo-yo” dieting) can have a bad impact on your health, including increased risk of heart disease and metabolism issues.

“The best thing you can do for your body, and to help you lose weight, is to stop dieting,” Dr. Ikeji says. “Incorporate whole foods into your diet and make sure you move your body. If you don’t, you’ll be chasing that diet into your 80s and feeling guilty over a piece of cake forever. That’s no way to live life.”
 

The bad: vitamin C contraceptive

In this TikTok, user @itsdiosa reveals her contraception hack for anyone with a uterus who may be having unprotected sex. She claims that for those who forget to take the Plan B pill, vitamin C is a worthwhile substitute in preventing unwanted pregnancy. She recommends taking four or five vitamin C tablets a day for a few days for the return of a normal period.

Not surprisingly, Vitamin C isn’t safe or reliable and doesn’t have studies to back up @itsdiosa’s claim. If anything, all you’ll get from taking too much vitamin C is diarrhea and a stomachache.

Karan Rajan, MBBS, from Imperial College London and the University of Sunderland in the United Kingdom, responded to the TikTok to confirm that this claim isn’t backed up by science.

“Vitamin C doesn’t start or stop a period. Period,” he commented on the video.
 

The ugly: garlic sinus decongestant

Now this one went viral one went viral with over 5.2 million likes. In this TikTok, @hwannah5 and her boyfriend try out a trend that involves putting a clove of peeled garlic in each nostril in order to clear up congestion. The bubbles of ooey gooey snot coming out of her boyfriend’s nose certainly make it seem like it’s working, but what’s really going on?

 

 

This is hardly new; people have been putting strange things in nasal rinses for some time now and garlic is a tried-and-true favorite. Garlic does have some medically valid uses. These studies have shown that garlic taken orally may improve insulin in people with diabetes, slightly lower cholesterol, and reduce blood pressure in people with hypertension. When it comes to home remedies, people have historically used garlic as an antiseptic, antibacterial, and antifungal agent, though these claims are not widely supported by research. But taking a garlic supplement and sticking raw garlic up your nose are two very different things.

New York-based board-certified dermatologist Whitney Bowe, MD, weighed in on the viral trend.

In her own reaction video, she explained: “Guys, this is actually not safe. What’s happening is the garlic is actually triggering something called contact dermatitis and the mucosa is trying to protect itself by secreting tons of mucus. It’s creating swelling.”

For those tempted by this smelly “remedy,” a few drops of essential oil in a steamy shower is a much more pleasant (and significantly less gross) way to treat congestion.

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

The year is rapidly approaching an end, and with it, we can perhaps look forward to better and brighter days in 2022. With daylight savings, seasonal depression, and cold and flu season making a comeback as temperatures across the Northern Hemisphere drop, some strange remedies have been appearing on TikTok – as they often do.

The good: doctor reveals the truth about dieting

Chisom Ikeji, MD, is a critical care clinical fellow at the University of Pittsburgh Medical Center and on TikTok under the username @drchizmd. In a TikTok with almost 200,000 views and over 18,000 likes, Dr. Ikeji explains to all New Year’s resolution-makers that dieting isn’t all it’s cracked up to be. “Dieting leads to perpetually losing weight and gaining weight on a cycle,” she says, “so that your body never really settles at its set point weight.”

Celebrities and your friends who drink lemon water in the morning may tout all sorts of fad diets and some of them might even work. But Dr. Ikeji explains that diets with gimmicks don’t have lasting power and create cycles of losing and gaining weight. Additionally, associating “points” with foods, or separating them into “good” or “bad” categories, encourages habits that can lead to disordered eating.

The best way to keep weight off is to make actual lifestyle changes that stick. In contrast, going back to dieting every year (the rapid cycle of losing and gaining weight is called  “yo-yo” dieting) can have a bad impact on your health, including increased risk of heart disease and metabolism issues.

“The best thing you can do for your body, and to help you lose weight, is to stop dieting,” Dr. Ikeji says. “Incorporate whole foods into your diet and make sure you move your body. If you don’t, you’ll be chasing that diet into your 80s and feeling guilty over a piece of cake forever. That’s no way to live life.”
 

The bad: vitamin C contraceptive

In this TikTok, user @itsdiosa reveals her contraception hack for anyone with a uterus who may be having unprotected sex. She claims that for those who forget to take the Plan B pill, vitamin C is a worthwhile substitute in preventing unwanted pregnancy. She recommends taking four or five vitamin C tablets a day for a few days for the return of a normal period.

Not surprisingly, Vitamin C isn’t safe or reliable and doesn’t have studies to back up @itsdiosa’s claim. If anything, all you’ll get from taking too much vitamin C is diarrhea and a stomachache.

Karan Rajan, MBBS, from Imperial College London and the University of Sunderland in the United Kingdom, responded to the TikTok to confirm that this claim isn’t backed up by science.

“Vitamin C doesn’t start or stop a period. Period,” he commented on the video.
 

The ugly: garlic sinus decongestant

Now this one went viral one went viral with over 5.2 million likes. In this TikTok, @hwannah5 and her boyfriend try out a trend that involves putting a clove of peeled garlic in each nostril in order to clear up congestion. The bubbles of ooey gooey snot coming out of her boyfriend’s nose certainly make it seem like it’s working, but what’s really going on?

 

 

This is hardly new; people have been putting strange things in nasal rinses for some time now and garlic is a tried-and-true favorite. Garlic does have some medically valid uses. These studies have shown that garlic taken orally may improve insulin in people with diabetes, slightly lower cholesterol, and reduce blood pressure in people with hypertension. When it comes to home remedies, people have historically used garlic as an antiseptic, antibacterial, and antifungal agent, though these claims are not widely supported by research. But taking a garlic supplement and sticking raw garlic up your nose are two very different things.

New York-based board-certified dermatologist Whitney Bowe, MD, weighed in on the viral trend.

In her own reaction video, she explained: “Guys, this is actually not safe. What’s happening is the garlic is actually triggering something called contact dermatitis and the mucosa is trying to protect itself by secreting tons of mucus. It’s creating swelling.”

For those tempted by this smelly “remedy,” a few drops of essential oil in a steamy shower is a much more pleasant (and significantly less gross) way to treat congestion.

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

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Female patients fare worse with male surgeons, study finds

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Female patients are more likely to experience adverse outcomes following common surgical procedures when treated by a male rather than a female surgeon, according to a new analysis of over 1.3 million surgery patients. The study found no difference in adverse outcomes in male patients treated by surgeons of either sex.

While the effect of patient and provider sex discordance (female patient/male physician or male patient/female physician) on care has been explored before, “to the best of our knowledge, this is the first study to assess this in patients undergoing surgery,” Christopher Wallis, MD, PhD, an assistant professor in the division of urology at the University of Toronto, said in an email. The study was published online December 8 in JAMA Surgery.

Past studies in primary care settings have found that sex discordance between a physician and patient can result in “worse rapport, lower certainty of diagnosis, lower likelihood of assessing patient’s conditions as being of high severity, concerns of a hidden agenda, and disagreements regarding advice provided,” the authors write in the paper. Gender discordance has also been shown to negatively affect cancer screening rates and survival after heart attack. Given these past findings, Dr. Wallis and colleagues postulated that gender match between patients and surgeons could affect postoperative outcomes.

To find out, researchers analyzed data from over 1,320,100 patients undergoing one of 21 common elective and emergent surgical procedures in Ontario, Canada, from January 1, 2007, through December 31, 2019. Procedures were performed across the following specialties: cardiothoracic surgery, general surgery, neurosurgery, orthopedic surgery, otolaryngology, plastic surgery, thoracic surgery, urology, and vascular surgery. The investigators compared adverse postoperative outcomes — death, readmission, or complications within 30 days after surgery — in patients of both sexes when treated by male or female surgeons.

The study included 2,937 surgeons, and nearly 46% of patients included in the study were the same sex as their surgeon. Of the remaining 717,548 sex-discordant pairings, 93% were female patients with male surgeons, and 7% were male patients with female surgeons.

Among all patients, 14.9% experienced at least one adverse outcome. The researchers found that sex discordance between patient and surgeon was associated with higher odds of complications (adjusted odds ratio [aOR], 1.09; 95% CI, 1.07 – 1.11) and death (aOR, 1.07; 95% CI, 1.02 – 1.13). There was no statistically significant relationship between sex discordance and readmission in the study.

Using multivariable modeling, the researchers then teased out how patient sex affected this association. They found that female patients treated by male surgeons, compared to those treated by female surgeons, were more likely to have worse outcomes (aOR, 1.15; 95% CI, 1.10 – 1.20); however, there was no difference in outcomes in male patients treated by female surgeons compared with those with male surgeons (aOR, 0.99; 95% CI, 0.95 – 1.03).

While the study did not look at the underlying reasons for this disparity, communication differences between surgeons and patients could be one factor, Dr. Wallis noted. “Prior research has suggested differences in communication style between male and female physicians. Further, there is evidence that female physicians, including surgeons, spend more time with patients,” he wrote in an email. “This, coupled with evidence that female patients may have disparities in the management of their pain, suggest that communication differences may underpin the observed disparity.”

The finding “sounds the alarm for urgent action,” write Andrea Riner, MD, MPH, and Amalia Cochran, MD, both from the department of surgery at the University of Florida College of Medicine in Gainesville, in an accompanying commentary. While recruiting more women into surgical specialties is one way to address this disparity, both Dr. Riner and Dr. Cochran note the importance of identifying unconscious biases in patient care. “Surgeons likely believe they provide the same quality of care to patients irrespective of identity,” they write. “However, these data underscore an underappreciated phenomenon and highlight a measurable repercussion of implicit bias.”

Training programs that work with surgeons to improve communication and care with diverse patients may help counter these biases, they suggest, and incorporating patient identity in surgical outcome metrics could help identify biases. “Female patients with surgical disease should not be disadvantaged because there simply are not enough female surgeons or surgeons who are competent in the care of female patients,” they note. “We owe it to patients to provide them with the best outcomes, regardless of how their identities may align with ours.”

Dr. Riner reports grants from the National Human Genome Research Institute and the National Cancer Institute.Dr. Cochran is a section editor for UpToDate. Dr. Wallis reports no relevant financial relationships.

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

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Female patients are more likely to experience adverse outcomes following common surgical procedures when treated by a male rather than a female surgeon, according to a new analysis of over 1.3 million surgery patients. The study found no difference in adverse outcomes in male patients treated by surgeons of either sex.

While the effect of patient and provider sex discordance (female patient/male physician or male patient/female physician) on care has been explored before, “to the best of our knowledge, this is the first study to assess this in patients undergoing surgery,” Christopher Wallis, MD, PhD, an assistant professor in the division of urology at the University of Toronto, said in an email. The study was published online December 8 in JAMA Surgery.

Past studies in primary care settings have found that sex discordance between a physician and patient can result in “worse rapport, lower certainty of diagnosis, lower likelihood of assessing patient’s conditions as being of high severity, concerns of a hidden agenda, and disagreements regarding advice provided,” the authors write in the paper. Gender discordance has also been shown to negatively affect cancer screening rates and survival after heart attack. Given these past findings, Dr. Wallis and colleagues postulated that gender match between patients and surgeons could affect postoperative outcomes.

To find out, researchers analyzed data from over 1,320,100 patients undergoing one of 21 common elective and emergent surgical procedures in Ontario, Canada, from January 1, 2007, through December 31, 2019. Procedures were performed across the following specialties: cardiothoracic surgery, general surgery, neurosurgery, orthopedic surgery, otolaryngology, plastic surgery, thoracic surgery, urology, and vascular surgery. The investigators compared adverse postoperative outcomes — death, readmission, or complications within 30 days after surgery — in patients of both sexes when treated by male or female surgeons.

The study included 2,937 surgeons, and nearly 46% of patients included in the study were the same sex as their surgeon. Of the remaining 717,548 sex-discordant pairings, 93% were female patients with male surgeons, and 7% were male patients with female surgeons.

Among all patients, 14.9% experienced at least one adverse outcome. The researchers found that sex discordance between patient and surgeon was associated with higher odds of complications (adjusted odds ratio [aOR], 1.09; 95% CI, 1.07 – 1.11) and death (aOR, 1.07; 95% CI, 1.02 – 1.13). There was no statistically significant relationship between sex discordance and readmission in the study.

Using multivariable modeling, the researchers then teased out how patient sex affected this association. They found that female patients treated by male surgeons, compared to those treated by female surgeons, were more likely to have worse outcomes (aOR, 1.15; 95% CI, 1.10 – 1.20); however, there was no difference in outcomes in male patients treated by female surgeons compared with those with male surgeons (aOR, 0.99; 95% CI, 0.95 – 1.03).

While the study did not look at the underlying reasons for this disparity, communication differences between surgeons and patients could be one factor, Dr. Wallis noted. “Prior research has suggested differences in communication style between male and female physicians. Further, there is evidence that female physicians, including surgeons, spend more time with patients,” he wrote in an email. “This, coupled with evidence that female patients may have disparities in the management of their pain, suggest that communication differences may underpin the observed disparity.”

The finding “sounds the alarm for urgent action,” write Andrea Riner, MD, MPH, and Amalia Cochran, MD, both from the department of surgery at the University of Florida College of Medicine in Gainesville, in an accompanying commentary. While recruiting more women into surgical specialties is one way to address this disparity, both Dr. Riner and Dr. Cochran note the importance of identifying unconscious biases in patient care. “Surgeons likely believe they provide the same quality of care to patients irrespective of identity,” they write. “However, these data underscore an underappreciated phenomenon and highlight a measurable repercussion of implicit bias.”

Training programs that work with surgeons to improve communication and care with diverse patients may help counter these biases, they suggest, and incorporating patient identity in surgical outcome metrics could help identify biases. “Female patients with surgical disease should not be disadvantaged because there simply are not enough female surgeons or surgeons who are competent in the care of female patients,” they note. “We owe it to patients to provide them with the best outcomes, regardless of how their identities may align with ours.”

Dr. Riner reports grants from the National Human Genome Research Institute and the National Cancer Institute.Dr. Cochran is a section editor for UpToDate. Dr. Wallis reports no relevant financial relationships.

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

Female patients are more likely to experience adverse outcomes following common surgical procedures when treated by a male rather than a female surgeon, according to a new analysis of over 1.3 million surgery patients. The study found no difference in adverse outcomes in male patients treated by surgeons of either sex.

While the effect of patient and provider sex discordance (female patient/male physician or male patient/female physician) on care has been explored before, “to the best of our knowledge, this is the first study to assess this in patients undergoing surgery,” Christopher Wallis, MD, PhD, an assistant professor in the division of urology at the University of Toronto, said in an email. The study was published online December 8 in JAMA Surgery.

Past studies in primary care settings have found that sex discordance between a physician and patient can result in “worse rapport, lower certainty of diagnosis, lower likelihood of assessing patient’s conditions as being of high severity, concerns of a hidden agenda, and disagreements regarding advice provided,” the authors write in the paper. Gender discordance has also been shown to negatively affect cancer screening rates and survival after heart attack. Given these past findings, Dr. Wallis and colleagues postulated that gender match between patients and surgeons could affect postoperative outcomes.

To find out, researchers analyzed data from over 1,320,100 patients undergoing one of 21 common elective and emergent surgical procedures in Ontario, Canada, from January 1, 2007, through December 31, 2019. Procedures were performed across the following specialties: cardiothoracic surgery, general surgery, neurosurgery, orthopedic surgery, otolaryngology, plastic surgery, thoracic surgery, urology, and vascular surgery. The investigators compared adverse postoperative outcomes — death, readmission, or complications within 30 days after surgery — in patients of both sexes when treated by male or female surgeons.

The study included 2,937 surgeons, and nearly 46% of patients included in the study were the same sex as their surgeon. Of the remaining 717,548 sex-discordant pairings, 93% were female patients with male surgeons, and 7% were male patients with female surgeons.

Among all patients, 14.9% experienced at least one adverse outcome. The researchers found that sex discordance between patient and surgeon was associated with higher odds of complications (adjusted odds ratio [aOR], 1.09; 95% CI, 1.07 – 1.11) and death (aOR, 1.07; 95% CI, 1.02 – 1.13). There was no statistically significant relationship between sex discordance and readmission in the study.

Using multivariable modeling, the researchers then teased out how patient sex affected this association. They found that female patients treated by male surgeons, compared to those treated by female surgeons, were more likely to have worse outcomes (aOR, 1.15; 95% CI, 1.10 – 1.20); however, there was no difference in outcomes in male patients treated by female surgeons compared with those with male surgeons (aOR, 0.99; 95% CI, 0.95 – 1.03).

While the study did not look at the underlying reasons for this disparity, communication differences between surgeons and patients could be one factor, Dr. Wallis noted. “Prior research has suggested differences in communication style between male and female physicians. Further, there is evidence that female physicians, including surgeons, spend more time with patients,” he wrote in an email. “This, coupled with evidence that female patients may have disparities in the management of their pain, suggest that communication differences may underpin the observed disparity.”

The finding “sounds the alarm for urgent action,” write Andrea Riner, MD, MPH, and Amalia Cochran, MD, both from the department of surgery at the University of Florida College of Medicine in Gainesville, in an accompanying commentary. While recruiting more women into surgical specialties is one way to address this disparity, both Dr. Riner and Dr. Cochran note the importance of identifying unconscious biases in patient care. “Surgeons likely believe they provide the same quality of care to patients irrespective of identity,” they write. “However, these data underscore an underappreciated phenomenon and highlight a measurable repercussion of implicit bias.”

Training programs that work with surgeons to improve communication and care with diverse patients may help counter these biases, they suggest, and incorporating patient identity in surgical outcome metrics could help identify biases. “Female patients with surgical disease should not be disadvantaged because there simply are not enough female surgeons or surgeons who are competent in the care of female patients,” they note. “We owe it to patients to provide them with the best outcomes, regardless of how their identities may align with ours.”

Dr. Riner reports grants from the National Human Genome Research Institute and the National Cancer Institute.Dr. Cochran is a section editor for UpToDate. Dr. Wallis reports no relevant financial relationships.

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

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