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Is a progression-free survival benefit alone really worth $10,000 a month?
In the field of lung cancer, and more broadly in oncology, many of our biggest advances in 2021 have come as clinically meaningful improvements in surrogate endpoints – disease-free survival, progression-free survival, and sometimes even pathologic complete response rate.
I have historically been most compelled to consider new findings to be practice-changing when they improve overall survival or quality of life – the endpoints that translate to direct benefits for patients. However, I also feel it is appropriate to call surrogate endpoints practice-changing when they can predict improvements in overall survival or quality of life.
Take the PACIFIC trial, which assessed maintenance durvalumab after concurrent chemoradiation for unresectable stage III non–small cell lung cancer (NSCLC).
Back in 2017, I was initially unconvinced by the interim phase 3 data that were presented in a press release that highlighted the disease-free survival benefit. However, after examining additional data more closely, I saw the dramatic improvement in time to distant relapse or death was overwhelmingly likely to predict an improvement in overall survival – a benefit that the data subsequently bore out.
More recently, the disease-free survival results for adjuvant osimertinib in resected endothelial growth factor receptor mutation–positive NSCLC and adjuvant atezolizumab in resected programmed death-ligand 1–positive stage II-IIIA NSCLC have led to excitement about Food and Drug Administration approvals for these therapies. Although there is reason to be cautious about the likelihood of an overall survival benefit with either therapy – particularly for patients with low programmed death-ligand 1 who receive atezolizumab – I think that the results are promising enough to discuss these treatment options with appropriate patients.
Some argue, however, that overall survival is not necessarily a critical goal and that certain surrogate endpoints are inherently beneficial. Patients and oncologists may, for instance, view delaying disease progression as a win, even if overall survival remains the same.
I appreciate the view that favorable scan results are an achievement, even without a survival benefit. Patients appreciate the good news, and it is gratifying for us to deliver it. However, what remains unspoken is whether the benefit can be provided at a reasonable value given the financial costs associated with the new treatment.
In the United States, we consider the physician-patient relationship to be autonomous and even revered, but we conveniently ignore the fact that both are deciding on treatments that are funded by people who are not represented in the room. And in a health care system that fails to cover basic cancer care needs as well as other critical, high-value interventions for both the uninsured and underinsured, we should acknowledge that our decisions redirect limited resources from others.
Is it the best use of $10,000 per month for a new drug that improves disease-free survival but not overall survival?
At the same time, we also have to remain vigilant and reflect on whether we are echoing the marketing messages of the companies selling these treatments. Having recently watched the excellent Hulu series Dopesick, which realistically portrays the medical community’s egregious overuse of Oxycontin at the behest of Purdue Pharmaceuticals, it is striking to see how effectively the pharmaceutical industry can co-opt stakeholders. Very few physicians or patients have expertise in health care policy with broad societal perspective, yet subspecialists offer edicts as if society should dedicate unlimited resources first and foremost to our career focus or personal cause.
I certainly appreciate the appeal of surrogate endpoints in a world in which we hope to offer novel therapies to patients in a timely fashion. In the next few years, some of our most promising data in oncology will demand that we consider whether surrogate endpoints are practice-changing. We are facing a fundamental question: Are we using these surrogate endpoints to predict overall survival or quality of life or do these endpoints stand on their own as practice-changing metrics?
We need to acknowledge that our primary clinical focus is not the only one that deserves our attention, particularly when our treatment decisions are, in fact, spending other people’s money. We should be asking not whether we prefer to deliver good news after a scan, but whether that alone is enough to justify the high cost of a new treatment without an overall survival benefit.
Dr. West disclosed serving as a director, officer, partner, employee, adviser, consultant, or trustee for Ariad/Takeda, Bristol-Myers Squibb, Boehringer Ingelheim, Spectrum, AstraZeneca, Celgene, Genentech/Roche, Pfizer, and Merck; serving as a speaker or a member of a speakers bureau for Ariad/Takeda, AstraZeneca, and Genentech/Roche; and receiving income from Eli Lilly. A version of this article first appeared on Medscape.com.
In the field of lung cancer, and more broadly in oncology, many of our biggest advances in 2021 have come as clinically meaningful improvements in surrogate endpoints – disease-free survival, progression-free survival, and sometimes even pathologic complete response rate.
I have historically been most compelled to consider new findings to be practice-changing when they improve overall survival or quality of life – the endpoints that translate to direct benefits for patients. However, I also feel it is appropriate to call surrogate endpoints practice-changing when they can predict improvements in overall survival or quality of life.
Take the PACIFIC trial, which assessed maintenance durvalumab after concurrent chemoradiation for unresectable stage III non–small cell lung cancer (NSCLC).
Back in 2017, I was initially unconvinced by the interim phase 3 data that were presented in a press release that highlighted the disease-free survival benefit. However, after examining additional data more closely, I saw the dramatic improvement in time to distant relapse or death was overwhelmingly likely to predict an improvement in overall survival – a benefit that the data subsequently bore out.
More recently, the disease-free survival results for adjuvant osimertinib in resected endothelial growth factor receptor mutation–positive NSCLC and adjuvant atezolizumab in resected programmed death-ligand 1–positive stage II-IIIA NSCLC have led to excitement about Food and Drug Administration approvals for these therapies. Although there is reason to be cautious about the likelihood of an overall survival benefit with either therapy – particularly for patients with low programmed death-ligand 1 who receive atezolizumab – I think that the results are promising enough to discuss these treatment options with appropriate patients.
Some argue, however, that overall survival is not necessarily a critical goal and that certain surrogate endpoints are inherently beneficial. Patients and oncologists may, for instance, view delaying disease progression as a win, even if overall survival remains the same.
I appreciate the view that favorable scan results are an achievement, even without a survival benefit. Patients appreciate the good news, and it is gratifying for us to deliver it. However, what remains unspoken is whether the benefit can be provided at a reasonable value given the financial costs associated with the new treatment.
In the United States, we consider the physician-patient relationship to be autonomous and even revered, but we conveniently ignore the fact that both are deciding on treatments that are funded by people who are not represented in the room. And in a health care system that fails to cover basic cancer care needs as well as other critical, high-value interventions for both the uninsured and underinsured, we should acknowledge that our decisions redirect limited resources from others.
Is it the best use of $10,000 per month for a new drug that improves disease-free survival but not overall survival?
At the same time, we also have to remain vigilant and reflect on whether we are echoing the marketing messages of the companies selling these treatments. Having recently watched the excellent Hulu series Dopesick, which realistically portrays the medical community’s egregious overuse of Oxycontin at the behest of Purdue Pharmaceuticals, it is striking to see how effectively the pharmaceutical industry can co-opt stakeholders. Very few physicians or patients have expertise in health care policy with broad societal perspective, yet subspecialists offer edicts as if society should dedicate unlimited resources first and foremost to our career focus or personal cause.
I certainly appreciate the appeal of surrogate endpoints in a world in which we hope to offer novel therapies to patients in a timely fashion. In the next few years, some of our most promising data in oncology will demand that we consider whether surrogate endpoints are practice-changing. We are facing a fundamental question: Are we using these surrogate endpoints to predict overall survival or quality of life or do these endpoints stand on their own as practice-changing metrics?
We need to acknowledge that our primary clinical focus is not the only one that deserves our attention, particularly when our treatment decisions are, in fact, spending other people’s money. We should be asking not whether we prefer to deliver good news after a scan, but whether that alone is enough to justify the high cost of a new treatment without an overall survival benefit.
Dr. West disclosed serving as a director, officer, partner, employee, adviser, consultant, or trustee for Ariad/Takeda, Bristol-Myers Squibb, Boehringer Ingelheim, Spectrum, AstraZeneca, Celgene, Genentech/Roche, Pfizer, and Merck; serving as a speaker or a member of a speakers bureau for Ariad/Takeda, AstraZeneca, and Genentech/Roche; and receiving income from Eli Lilly. A version of this article first appeared on Medscape.com.
In the field of lung cancer, and more broadly in oncology, many of our biggest advances in 2021 have come as clinically meaningful improvements in surrogate endpoints – disease-free survival, progression-free survival, and sometimes even pathologic complete response rate.
I have historically been most compelled to consider new findings to be practice-changing when they improve overall survival or quality of life – the endpoints that translate to direct benefits for patients. However, I also feel it is appropriate to call surrogate endpoints practice-changing when they can predict improvements in overall survival or quality of life.
Take the PACIFIC trial, which assessed maintenance durvalumab after concurrent chemoradiation for unresectable stage III non–small cell lung cancer (NSCLC).
Back in 2017, I was initially unconvinced by the interim phase 3 data that were presented in a press release that highlighted the disease-free survival benefit. However, after examining additional data more closely, I saw the dramatic improvement in time to distant relapse or death was overwhelmingly likely to predict an improvement in overall survival – a benefit that the data subsequently bore out.
More recently, the disease-free survival results for adjuvant osimertinib in resected endothelial growth factor receptor mutation–positive NSCLC and adjuvant atezolizumab in resected programmed death-ligand 1–positive stage II-IIIA NSCLC have led to excitement about Food and Drug Administration approvals for these therapies. Although there is reason to be cautious about the likelihood of an overall survival benefit with either therapy – particularly for patients with low programmed death-ligand 1 who receive atezolizumab – I think that the results are promising enough to discuss these treatment options with appropriate patients.
Some argue, however, that overall survival is not necessarily a critical goal and that certain surrogate endpoints are inherently beneficial. Patients and oncologists may, for instance, view delaying disease progression as a win, even if overall survival remains the same.
I appreciate the view that favorable scan results are an achievement, even without a survival benefit. Patients appreciate the good news, and it is gratifying for us to deliver it. However, what remains unspoken is whether the benefit can be provided at a reasonable value given the financial costs associated with the new treatment.
In the United States, we consider the physician-patient relationship to be autonomous and even revered, but we conveniently ignore the fact that both are deciding on treatments that are funded by people who are not represented in the room. And in a health care system that fails to cover basic cancer care needs as well as other critical, high-value interventions for both the uninsured and underinsured, we should acknowledge that our decisions redirect limited resources from others.
Is it the best use of $10,000 per month for a new drug that improves disease-free survival but not overall survival?
At the same time, we also have to remain vigilant and reflect on whether we are echoing the marketing messages of the companies selling these treatments. Having recently watched the excellent Hulu series Dopesick, which realistically portrays the medical community’s egregious overuse of Oxycontin at the behest of Purdue Pharmaceuticals, it is striking to see how effectively the pharmaceutical industry can co-opt stakeholders. Very few physicians or patients have expertise in health care policy with broad societal perspective, yet subspecialists offer edicts as if society should dedicate unlimited resources first and foremost to our career focus or personal cause.
I certainly appreciate the appeal of surrogate endpoints in a world in which we hope to offer novel therapies to patients in a timely fashion. In the next few years, some of our most promising data in oncology will demand that we consider whether surrogate endpoints are practice-changing. We are facing a fundamental question: Are we using these surrogate endpoints to predict overall survival or quality of life or do these endpoints stand on their own as practice-changing metrics?
We need to acknowledge that our primary clinical focus is not the only one that deserves our attention, particularly when our treatment decisions are, in fact, spending other people’s money. We should be asking not whether we prefer to deliver good news after a scan, but whether that alone is enough to justify the high cost of a new treatment without an overall survival benefit.
Dr. West disclosed serving as a director, officer, partner, employee, adviser, consultant, or trustee for Ariad/Takeda, Bristol-Myers Squibb, Boehringer Ingelheim, Spectrum, AstraZeneca, Celgene, Genentech/Roche, Pfizer, and Merck; serving as a speaker or a member of a speakers bureau for Ariad/Takeda, AstraZeneca, and Genentech/Roche; and receiving income from Eli Lilly. A version of this article first appeared on Medscape.com.
Cardiac arrest survival lower in COVID-19 inpatients
Survival after in-hospital cardiac arrest was roughly one-third lower in patients with COVID-19 infections compared to uninfected patients, based on data from nearly 25,000 individuals.
Survival rates of less than 3% were reported in the United States and China for patients who suffered in-hospital cardiac arrest (IHCA) while infected with COVID-19 early in the pandemic, but the data came from small, single-center studies in overwhelmed hospitals, wrote Saket Girotra, MD, of the University of Iowa, Iowa City, and fellow American Heart Association Get With the Guidelines–Resuscitation Investigators. Whether these early reports reflect the broader experience of patients with COVID-19 in hospitals in the United States remains unknown.
In a study published as a research letter in JAMA Network Open, the researchers reviewed data from the American Heart Association Get With the Guidelines–Resuscitation registry. The registry collects detailed information on patients aged 18 years and older who experience cardiac arrest at participating hospitals in the United States. The study population included 24,915 patients aged 18 years and older from 286 hospitals who experienced IHCA during March–December 2020. The mean age of the patients was 64.7 years; 61.1% were White, 24.8% were Black, 3.8% were of other race or ethnicity, and 10.3% were of unknown race or ethnicity.
The primary outcomes were survival to discharge and return of spontaneous circulation (ROSC) for at least 20 minutes.
A total of 5,916 patients (23.7%) had suspected or confirmed COVID-19 infections, and infected patients were more likely to be younger, male, and Black. Patients with COVID-19 infections also were significantly more likely than noninfected patients to have nonshockable rhythm, pneumonia, respiratory insufficiency, or sepsis, and to be on mechanical ventilation or vasopressors when the IHCA occurred, the researchers noted.
Survival rates to hospital discharge were 11.9% for COVID-19 patients, compared with 23.5% for noninfected patients (adjusted relative risk, 0.65; P < .001). ROSC was 53.7% and 63.6%, for infected and noninfected patients, respectively (aRR, 0.86; P < .001).
COVID-19 patients also were more likely than noninfected patients to receive delayed defibrillation, the researchers said. “Although delays in resuscitation, especially defibrillation, may have contributed to lower survival, the negative association of COVID-19 with survival in this study was consistent across subgroups, including patients who received timely treatment with defibrillation and epinephrine.”
The extremely low survival rate in early pandemic studies likely reflected the overwhelming burden on health systems at the time, the researchers said in their discussion.
The study findings were limited by several factors, including potential confounding from unmeasured variables, the use of a quality improvement registry that may not reflect nonparticipating hospitals, and potential false-positive COVID-19 cases. However, the result support findings from recent studies of multiple centers and extend clinical knowledge by comparing infected and noninfected patients from a larger group of hospitals than previously studied, the researchers said.
“We believe that these data will be relevant to health care providers and hospital administrators as the COVID-19 pandemic continues,” they concluded.
Think beyond COVID-19 for cardiac care
“Early during the pandemic, questions were raised whether COVID-19 patients should be treated with CPR,” Dr. Girotra said in an interview. “This was because initial studies had found a dismal survival of 0%-3% in COVID patients treated with CPR. The potential of transmitting the virus to health care professionals during CPR further heightened these concerns. We wanted to know whether the poor survival reported in these initial studies were broadly representative.”
Dr. Girotra said that some of the study findings were surprising. “We found that of all patients with IHCA in 2020 in our study, one in four were suspected or confirmed to have COVID-19 infection. We were surprised by the magnitude of COVID’s impact on the cardiac arrest incidence.”
The implications for clinical decision-making are to think outside of COVID-19 infection, said Dr. Girotra. In the current study, “Although overall survival of cardiac arrest in COVID-positive patients was 30% lower, compared to non-COVID patients, it was not as poor as previously reported. COVID-19 infection alone should not be considered the sole factor for making decisions regarding CPR.
“Over the past 2 decades, we have experienced large gains in survival for in-hospital cardiac arrest. However, the COVID-19 pandemic has eroded these gains,” said Dr. Girotra. “Future studies are needed to monitor the impact of any new variants on cardiac arrest care,” as well as studies “to see whether we return to the prepandemic levels of IHCA survival once the pandemic recedes.”
Dr. Girotra has no relevant financial disclosures.
Survival after in-hospital cardiac arrest was roughly one-third lower in patients with COVID-19 infections compared to uninfected patients, based on data from nearly 25,000 individuals.
Survival rates of less than 3% were reported in the United States and China for patients who suffered in-hospital cardiac arrest (IHCA) while infected with COVID-19 early in the pandemic, but the data came from small, single-center studies in overwhelmed hospitals, wrote Saket Girotra, MD, of the University of Iowa, Iowa City, and fellow American Heart Association Get With the Guidelines–Resuscitation Investigators. Whether these early reports reflect the broader experience of patients with COVID-19 in hospitals in the United States remains unknown.
In a study published as a research letter in JAMA Network Open, the researchers reviewed data from the American Heart Association Get With the Guidelines–Resuscitation registry. The registry collects detailed information on patients aged 18 years and older who experience cardiac arrest at participating hospitals in the United States. The study population included 24,915 patients aged 18 years and older from 286 hospitals who experienced IHCA during March–December 2020. The mean age of the patients was 64.7 years; 61.1% were White, 24.8% were Black, 3.8% were of other race or ethnicity, and 10.3% were of unknown race or ethnicity.
The primary outcomes were survival to discharge and return of spontaneous circulation (ROSC) for at least 20 minutes.
A total of 5,916 patients (23.7%) had suspected or confirmed COVID-19 infections, and infected patients were more likely to be younger, male, and Black. Patients with COVID-19 infections also were significantly more likely than noninfected patients to have nonshockable rhythm, pneumonia, respiratory insufficiency, or sepsis, and to be on mechanical ventilation or vasopressors when the IHCA occurred, the researchers noted.
Survival rates to hospital discharge were 11.9% for COVID-19 patients, compared with 23.5% for noninfected patients (adjusted relative risk, 0.65; P < .001). ROSC was 53.7% and 63.6%, for infected and noninfected patients, respectively (aRR, 0.86; P < .001).
COVID-19 patients also were more likely than noninfected patients to receive delayed defibrillation, the researchers said. “Although delays in resuscitation, especially defibrillation, may have contributed to lower survival, the negative association of COVID-19 with survival in this study was consistent across subgroups, including patients who received timely treatment with defibrillation and epinephrine.”
The extremely low survival rate in early pandemic studies likely reflected the overwhelming burden on health systems at the time, the researchers said in their discussion.
The study findings were limited by several factors, including potential confounding from unmeasured variables, the use of a quality improvement registry that may not reflect nonparticipating hospitals, and potential false-positive COVID-19 cases. However, the result support findings from recent studies of multiple centers and extend clinical knowledge by comparing infected and noninfected patients from a larger group of hospitals than previously studied, the researchers said.
“We believe that these data will be relevant to health care providers and hospital administrators as the COVID-19 pandemic continues,” they concluded.
Think beyond COVID-19 for cardiac care
“Early during the pandemic, questions were raised whether COVID-19 patients should be treated with CPR,” Dr. Girotra said in an interview. “This was because initial studies had found a dismal survival of 0%-3% in COVID patients treated with CPR. The potential of transmitting the virus to health care professionals during CPR further heightened these concerns. We wanted to know whether the poor survival reported in these initial studies were broadly representative.”
Dr. Girotra said that some of the study findings were surprising. “We found that of all patients with IHCA in 2020 in our study, one in four were suspected or confirmed to have COVID-19 infection. We were surprised by the magnitude of COVID’s impact on the cardiac arrest incidence.”
The implications for clinical decision-making are to think outside of COVID-19 infection, said Dr. Girotra. In the current study, “Although overall survival of cardiac arrest in COVID-positive patients was 30% lower, compared to non-COVID patients, it was not as poor as previously reported. COVID-19 infection alone should not be considered the sole factor for making decisions regarding CPR.
“Over the past 2 decades, we have experienced large gains in survival for in-hospital cardiac arrest. However, the COVID-19 pandemic has eroded these gains,” said Dr. Girotra. “Future studies are needed to monitor the impact of any new variants on cardiac arrest care,” as well as studies “to see whether we return to the prepandemic levels of IHCA survival once the pandemic recedes.”
Dr. Girotra has no relevant financial disclosures.
Survival after in-hospital cardiac arrest was roughly one-third lower in patients with COVID-19 infections compared to uninfected patients, based on data from nearly 25,000 individuals.
Survival rates of less than 3% were reported in the United States and China for patients who suffered in-hospital cardiac arrest (IHCA) while infected with COVID-19 early in the pandemic, but the data came from small, single-center studies in overwhelmed hospitals, wrote Saket Girotra, MD, of the University of Iowa, Iowa City, and fellow American Heart Association Get With the Guidelines–Resuscitation Investigators. Whether these early reports reflect the broader experience of patients with COVID-19 in hospitals in the United States remains unknown.
In a study published as a research letter in JAMA Network Open, the researchers reviewed data from the American Heart Association Get With the Guidelines–Resuscitation registry. The registry collects detailed information on patients aged 18 years and older who experience cardiac arrest at participating hospitals in the United States. The study population included 24,915 patients aged 18 years and older from 286 hospitals who experienced IHCA during March–December 2020. The mean age of the patients was 64.7 years; 61.1% were White, 24.8% were Black, 3.8% were of other race or ethnicity, and 10.3% were of unknown race or ethnicity.
The primary outcomes were survival to discharge and return of spontaneous circulation (ROSC) for at least 20 minutes.
A total of 5,916 patients (23.7%) had suspected or confirmed COVID-19 infections, and infected patients were more likely to be younger, male, and Black. Patients with COVID-19 infections also were significantly more likely than noninfected patients to have nonshockable rhythm, pneumonia, respiratory insufficiency, or sepsis, and to be on mechanical ventilation or vasopressors when the IHCA occurred, the researchers noted.
Survival rates to hospital discharge were 11.9% for COVID-19 patients, compared with 23.5% for noninfected patients (adjusted relative risk, 0.65; P < .001). ROSC was 53.7% and 63.6%, for infected and noninfected patients, respectively (aRR, 0.86; P < .001).
COVID-19 patients also were more likely than noninfected patients to receive delayed defibrillation, the researchers said. “Although delays in resuscitation, especially defibrillation, may have contributed to lower survival, the negative association of COVID-19 with survival in this study was consistent across subgroups, including patients who received timely treatment with defibrillation and epinephrine.”
The extremely low survival rate in early pandemic studies likely reflected the overwhelming burden on health systems at the time, the researchers said in their discussion.
The study findings were limited by several factors, including potential confounding from unmeasured variables, the use of a quality improvement registry that may not reflect nonparticipating hospitals, and potential false-positive COVID-19 cases. However, the result support findings from recent studies of multiple centers and extend clinical knowledge by comparing infected and noninfected patients from a larger group of hospitals than previously studied, the researchers said.
“We believe that these data will be relevant to health care providers and hospital administrators as the COVID-19 pandemic continues,” they concluded.
Think beyond COVID-19 for cardiac care
“Early during the pandemic, questions were raised whether COVID-19 patients should be treated with CPR,” Dr. Girotra said in an interview. “This was because initial studies had found a dismal survival of 0%-3% in COVID patients treated with CPR. The potential of transmitting the virus to health care professionals during CPR further heightened these concerns. We wanted to know whether the poor survival reported in these initial studies were broadly representative.”
Dr. Girotra said that some of the study findings were surprising. “We found that of all patients with IHCA in 2020 in our study, one in four were suspected or confirmed to have COVID-19 infection. We were surprised by the magnitude of COVID’s impact on the cardiac arrest incidence.”
The implications for clinical decision-making are to think outside of COVID-19 infection, said Dr. Girotra. In the current study, “Although overall survival of cardiac arrest in COVID-positive patients was 30% lower, compared to non-COVID patients, it was not as poor as previously reported. COVID-19 infection alone should not be considered the sole factor for making decisions regarding CPR.
“Over the past 2 decades, we have experienced large gains in survival for in-hospital cardiac arrest. However, the COVID-19 pandemic has eroded these gains,” said Dr. Girotra. “Future studies are needed to monitor the impact of any new variants on cardiac arrest care,” as well as studies “to see whether we return to the prepandemic levels of IHCA survival once the pandemic recedes.”
Dr. Girotra has no relevant financial disclosures.
FROM JAMA NETWORK OPEN
Proper steps for physicians to follow if they find themselves under investigation
Physician clients will find themselves in difficult legal situations from time to time. Sometimes it’s an investigation for Medicare fraud or other illegal conduct. Other times it’s a review related to Drug Enforcement Administration or licensure compliance. More commonly, physicians are involved in employer inquiries into workplace misconduct.
but how they choose to deal with the issue can have significant consequences.
In my opinion, physicians should have a relationship with a health care lawyer or firm in place before any investigation occurs. Whether they are being investigated for a license or medical staff issue, Medicare fraud, or contract issue, it’s important to know where to go for help quickly. Even if the physician does not retain a lawyer in advance, having the name of a qualified person who can be called for a variety of health care issues is already a step in the right direction.
More important than having a knowledgeable lawyer is actually contacting that lawyer. Some physicians will sit and chat with the Federal Bureau of Investigation or other investigators for hours, only to call me after the visitors leave. I have other clients who handle important medical staff hearings, discipline meetings, and license investigations on their own without consulting counsel first. In all of these situations, it can be too late to help a physician once their case has progressed too far down the road.
Employment issues arising in the workplace setting are the most common and troubling. Physicians will – without a second thought – attend a human resources–called or other meeting without thinking through the reason for the meeting, whether they are prepared or not, and without considering whether counsel could be helpful. Sometimes in the moment, there may be no choice, but most meetings are scheduled in advance with ample time for consultation and planning.
Many issues that arise in the workplace setting are troubling because they can be easily avoided. The No. 1 piece of advice which I offer to young physician clients as they enter the workplace is: Remember that nobody in the workplace is your friend. Every word that is said, text that is sent, gesture that is made, can put you at risk. You must assume that all conversations and messages will be shared with others. Joking around in the operating room about sexual escapades, sending texts with flirtatious comments, making comments that can be construed as racist or homophobic, or raising your voice in a moment of frustration are all real examples of situations where physicians ended up disciplined and terminated. Are these innocent comments or ones the doctor thought they could get away with among “friends?” From a human resources perspective, there is little tolerance for such conduct, regardless of the doctor’s intent.
There are also situations in the workplace that are more troubling. Many times a physician is accused of noncompliance with a contract or a policy, when in fact the accuser is retaliating or engaging in efforts to discredit a doctor. I have seen this happen where minority physicians complain about how they are treated and are suddenly investigated for a performance issue. I have had female physicians criticize a business decision at a committee meeting, only to receive a formal notice that their “negative attitude” violated a policy.
In these situations, talking with counsel before a meeting with the employer representative is recommended and can impact the trajectory of a physician’s career. Physicians cannot and should not handle such events on their own.
If a physician is forced or chooses to attend a meeting with an investigator or other party without counsel, there are some steps to consider (subject to the type of meeting and the specific circumstances).
- Listen more than you talk. Make sure you know the name of everyone who is present and their role within the organization.
- If you have previously provided any written or oral statements, or have written correspondence related to the issues at hand, review all materials in advance. If there is anything you think needs to be corrected or added, let the interviewer know that at the outset.
- Be familiar with your own employment agreement/policies and the terms that may be relevant to the discussion or meeting.
- Be calm, honest, and forthcoming in response to the questions, and don’t embellish or exaggerate.
- Avoid personal attacks on anyone. This generally serves to weaken an argument and credibility.
- Be prepared to explain your allegations or defense, and when you do so, keep in mind that the interviewer may not know the history, background, or details of any of the issues.
- If the reason for the situation relates to race or national origin, age, gender, sexual orientation, disability, or other protected category, don’t hesitate to say so.
- Answer the question you’re asked, but if you feel that the interviewer needs more information or is not understanding what you’ve said, feel free to explain. Be forthcoming, but don’t dominate the conversation.
- If they ask whether you have counsel, be honest, but decline to provide them any information about what you discussed with counsel, as those conversations are privileged.
- If the interviewer asks to record the conversation, you can agree, but ask to be provided a copy of the recording.
- Know your rights in advance. If the subject of the meeting is governed by bylaws or policies, for example, you may have the right to bring an attorney or adviser to the meeting, receive advance notice of who will be attending the meeting and the subject matter, and avail yourself of specific procedures or appeal rights of any discipline or decisions decided during the meeting.
There are many circumstances that can lead to a physician being under investigation or interrogation. In every single circumstance, it is ideal to seek legal counsel immediately. Whether the physician has actually engaged in wrongful conduct or not, without proper handling a physician’s career can be permanently, and sometimes irrevocably, affected.
Ms. Adler is a shareholder and health law practice group manager for Chicago-based law firm Roetzel, a member of the Illinois Association of Healthcare Attorneys, and a current advisory board member at DePaul College of Law Health Law Institute. She disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Physician clients will find themselves in difficult legal situations from time to time. Sometimes it’s an investigation for Medicare fraud or other illegal conduct. Other times it’s a review related to Drug Enforcement Administration or licensure compliance. More commonly, physicians are involved in employer inquiries into workplace misconduct.
but how they choose to deal with the issue can have significant consequences.
In my opinion, physicians should have a relationship with a health care lawyer or firm in place before any investigation occurs. Whether they are being investigated for a license or medical staff issue, Medicare fraud, or contract issue, it’s important to know where to go for help quickly. Even if the physician does not retain a lawyer in advance, having the name of a qualified person who can be called for a variety of health care issues is already a step in the right direction.
More important than having a knowledgeable lawyer is actually contacting that lawyer. Some physicians will sit and chat with the Federal Bureau of Investigation or other investigators for hours, only to call me after the visitors leave. I have other clients who handle important medical staff hearings, discipline meetings, and license investigations on their own without consulting counsel first. In all of these situations, it can be too late to help a physician once their case has progressed too far down the road.
Employment issues arising in the workplace setting are the most common and troubling. Physicians will – without a second thought – attend a human resources–called or other meeting without thinking through the reason for the meeting, whether they are prepared or not, and without considering whether counsel could be helpful. Sometimes in the moment, there may be no choice, but most meetings are scheduled in advance with ample time for consultation and planning.
Many issues that arise in the workplace setting are troubling because they can be easily avoided. The No. 1 piece of advice which I offer to young physician clients as they enter the workplace is: Remember that nobody in the workplace is your friend. Every word that is said, text that is sent, gesture that is made, can put you at risk. You must assume that all conversations and messages will be shared with others. Joking around in the operating room about sexual escapades, sending texts with flirtatious comments, making comments that can be construed as racist or homophobic, or raising your voice in a moment of frustration are all real examples of situations where physicians ended up disciplined and terminated. Are these innocent comments or ones the doctor thought they could get away with among “friends?” From a human resources perspective, there is little tolerance for such conduct, regardless of the doctor’s intent.
There are also situations in the workplace that are more troubling. Many times a physician is accused of noncompliance with a contract or a policy, when in fact the accuser is retaliating or engaging in efforts to discredit a doctor. I have seen this happen where minority physicians complain about how they are treated and are suddenly investigated for a performance issue. I have had female physicians criticize a business decision at a committee meeting, only to receive a formal notice that their “negative attitude” violated a policy.
In these situations, talking with counsel before a meeting with the employer representative is recommended and can impact the trajectory of a physician’s career. Physicians cannot and should not handle such events on their own.
If a physician is forced or chooses to attend a meeting with an investigator or other party without counsel, there are some steps to consider (subject to the type of meeting and the specific circumstances).
- Listen more than you talk. Make sure you know the name of everyone who is present and their role within the organization.
- If you have previously provided any written or oral statements, or have written correspondence related to the issues at hand, review all materials in advance. If there is anything you think needs to be corrected or added, let the interviewer know that at the outset.
- Be familiar with your own employment agreement/policies and the terms that may be relevant to the discussion or meeting.
- Be calm, honest, and forthcoming in response to the questions, and don’t embellish or exaggerate.
- Avoid personal attacks on anyone. This generally serves to weaken an argument and credibility.
- Be prepared to explain your allegations or defense, and when you do so, keep in mind that the interviewer may not know the history, background, or details of any of the issues.
- If the reason for the situation relates to race or national origin, age, gender, sexual orientation, disability, or other protected category, don’t hesitate to say so.
- Answer the question you’re asked, but if you feel that the interviewer needs more information or is not understanding what you’ve said, feel free to explain. Be forthcoming, but don’t dominate the conversation.
- If they ask whether you have counsel, be honest, but decline to provide them any information about what you discussed with counsel, as those conversations are privileged.
- If the interviewer asks to record the conversation, you can agree, but ask to be provided a copy of the recording.
- Know your rights in advance. If the subject of the meeting is governed by bylaws or policies, for example, you may have the right to bring an attorney or adviser to the meeting, receive advance notice of who will be attending the meeting and the subject matter, and avail yourself of specific procedures or appeal rights of any discipline or decisions decided during the meeting.
There are many circumstances that can lead to a physician being under investigation or interrogation. In every single circumstance, it is ideal to seek legal counsel immediately. Whether the physician has actually engaged in wrongful conduct or not, without proper handling a physician’s career can be permanently, and sometimes irrevocably, affected.
Ms. Adler is a shareholder and health law practice group manager for Chicago-based law firm Roetzel, a member of the Illinois Association of Healthcare Attorneys, and a current advisory board member at DePaul College of Law Health Law Institute. She disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Physician clients will find themselves in difficult legal situations from time to time. Sometimes it’s an investigation for Medicare fraud or other illegal conduct. Other times it’s a review related to Drug Enforcement Administration or licensure compliance. More commonly, physicians are involved in employer inquiries into workplace misconduct.
but how they choose to deal with the issue can have significant consequences.
In my opinion, physicians should have a relationship with a health care lawyer or firm in place before any investigation occurs. Whether they are being investigated for a license or medical staff issue, Medicare fraud, or contract issue, it’s important to know where to go for help quickly. Even if the physician does not retain a lawyer in advance, having the name of a qualified person who can be called for a variety of health care issues is already a step in the right direction.
More important than having a knowledgeable lawyer is actually contacting that lawyer. Some physicians will sit and chat with the Federal Bureau of Investigation or other investigators for hours, only to call me after the visitors leave. I have other clients who handle important medical staff hearings, discipline meetings, and license investigations on their own without consulting counsel first. In all of these situations, it can be too late to help a physician once their case has progressed too far down the road.
Employment issues arising in the workplace setting are the most common and troubling. Physicians will – without a second thought – attend a human resources–called or other meeting without thinking through the reason for the meeting, whether they are prepared or not, and without considering whether counsel could be helpful. Sometimes in the moment, there may be no choice, but most meetings are scheduled in advance with ample time for consultation and planning.
Many issues that arise in the workplace setting are troubling because they can be easily avoided. The No. 1 piece of advice which I offer to young physician clients as they enter the workplace is: Remember that nobody in the workplace is your friend. Every word that is said, text that is sent, gesture that is made, can put you at risk. You must assume that all conversations and messages will be shared with others. Joking around in the operating room about sexual escapades, sending texts with flirtatious comments, making comments that can be construed as racist or homophobic, or raising your voice in a moment of frustration are all real examples of situations where physicians ended up disciplined and terminated. Are these innocent comments or ones the doctor thought they could get away with among “friends?” From a human resources perspective, there is little tolerance for such conduct, regardless of the doctor’s intent.
There are also situations in the workplace that are more troubling. Many times a physician is accused of noncompliance with a contract or a policy, when in fact the accuser is retaliating or engaging in efforts to discredit a doctor. I have seen this happen where minority physicians complain about how they are treated and are suddenly investigated for a performance issue. I have had female physicians criticize a business decision at a committee meeting, only to receive a formal notice that their “negative attitude” violated a policy.
In these situations, talking with counsel before a meeting with the employer representative is recommended and can impact the trajectory of a physician’s career. Physicians cannot and should not handle such events on their own.
If a physician is forced or chooses to attend a meeting with an investigator or other party without counsel, there are some steps to consider (subject to the type of meeting and the specific circumstances).
- Listen more than you talk. Make sure you know the name of everyone who is present and their role within the organization.
- If you have previously provided any written or oral statements, or have written correspondence related to the issues at hand, review all materials in advance. If there is anything you think needs to be corrected or added, let the interviewer know that at the outset.
- Be familiar with your own employment agreement/policies and the terms that may be relevant to the discussion or meeting.
- Be calm, honest, and forthcoming in response to the questions, and don’t embellish or exaggerate.
- Avoid personal attacks on anyone. This generally serves to weaken an argument and credibility.
- Be prepared to explain your allegations or defense, and when you do so, keep in mind that the interviewer may not know the history, background, or details of any of the issues.
- If the reason for the situation relates to race or national origin, age, gender, sexual orientation, disability, or other protected category, don’t hesitate to say so.
- Answer the question you’re asked, but if you feel that the interviewer needs more information or is not understanding what you’ve said, feel free to explain. Be forthcoming, but don’t dominate the conversation.
- If they ask whether you have counsel, be honest, but decline to provide them any information about what you discussed with counsel, as those conversations are privileged.
- If the interviewer asks to record the conversation, you can agree, but ask to be provided a copy of the recording.
- Know your rights in advance. If the subject of the meeting is governed by bylaws or policies, for example, you may have the right to bring an attorney or adviser to the meeting, receive advance notice of who will be attending the meeting and the subject matter, and avail yourself of specific procedures or appeal rights of any discipline or decisions decided during the meeting.
There are many circumstances that can lead to a physician being under investigation or interrogation. In every single circumstance, it is ideal to seek legal counsel immediately. Whether the physician has actually engaged in wrongful conduct or not, without proper handling a physician’s career can be permanently, and sometimes irrevocably, affected.
Ms. Adler is a shareholder and health law practice group manager for Chicago-based law firm Roetzel, a member of the Illinois Association of Healthcare Attorneys, and a current advisory board member at DePaul College of Law Health Law Institute. She disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Self-care tips for clinicians as COVID-19 lingers
LAS VEGAS – according to Jon A. Levenson, MD.
“There are those who will need mental health treatment, so creating an easy way to reach out for help and facilitate linkage with care is critically important,” Dr. Levenson, associate professor of psychiatry at Columbia University Irving Medical Center, New York, said during an annual psychopharmacology update held by the Nevada Psychiatric Association. “The vast majority of our workforce will thrive with proper support. But what can each of us do to take care of ourselves?”
Step one is to recognize common stress reactions as well as signs of distress. He offered the oxygen mask metaphor, the idea that before we can take care of and support anyone else, we must first take care of ourselves. “When people are stressed, they don’t always think about the oxygen mask metaphor,” Dr. Levenson said. Step two is to practice and model self-care by adopting principles often discussed in acceptance and commitment therapy: to focus on what you can control, not on what you can’t control.
“We can’t control the amount of toilet paper at the grocery store, how long the pandemic will last, or how others have reacted,” Dr. Levenson said. “We also can’t control other people’s motives, predict what will happen, or the actions of others, including whether they will follow social distancing guidelines or not.”
How about what we can control? One is a positive attitude, “which can sustain people during times of intense stress,” he said. “Other things that we can do include turn off the news and find fun and enriching activities to do at home, whether it be playing a game with family or reaching out to friends through an iPad or a smartphone. You can also follow [Centers for Disease Control and Prevention] recommendations, control your own social distancing, and limit social media activity, which can be stressful. We can also control our kindness and grace.” He added that resilience does not mean “snapping back” to how you were before the pandemic, but rather “learning to integrate the adverse experiences into who you are and growing with them, which is sometimes known as posttraumatic growth.”
Dr. Levenson encouraged health care workers to use their coping resources, connect to others, and cultivate their values and purpose in life as they navigate these challenging times. “You also want to promote realistic optimism; find a way to stay positive,” he said. “We emphasize to our staff that while you won’t forget this time, focus on what you can control – your positive relationships – and remind yourself of your values and sources of gratitude. Figure out, and reflect on, what you care about, and then care about it. Remind yourself in a deliberate, purposeful way what anchors you to your job, which in the health care setting tends to be a desire to care for others, to assist those in need, and to work in teams. We also encourage staff to refrain from judgment. Guilt is a normal and near-universal response to this stressor, but there are many ways to contribute without a judgmental or guilty tone.”
Other tips for self-support are to remind yourself that it is not selfish to take breaks. “The needs of your patients are not more important than your own needs,” Dr. Levenson said. “Working nonstop can put you at higher risk for stress, exhaustion, and illness. You may need to give yourself more time to step back and recover from workplace challenges or extended coverage for peers; this is important. We remind our staff that your work may feel more emotionally draining than usual because everything is more intense overall during the COVID-19 pandemic. This reminder helps staff normalize what they already may be experiencing, and in turn, to further support each other.”
Soothing activities to relieve stress include meditation, prayer, deep and slow breathing, relaxation exercises, yoga, mindfulness, stretching, staying hydrated, eating healthfully, exercise, and getting sufficient sleep. Other stress management tips include avoiding excessive alcohol intake, reaching out to others, asking for assistance, and delegating when possible. “We want to promote psychological flexibility: the ability to stay in contact with the present moment,” he said. “We encourage our peers to be aware of unpleasant thoughts and feelings, and to try to redirect negative thought patterns to a proactive problem-solving approach; this includes choosing one’s behaviors based on the situation and personal values.”
Dr. Levenson reported having no disclosures related to his presentation.
LAS VEGAS – according to Jon A. Levenson, MD.
“There are those who will need mental health treatment, so creating an easy way to reach out for help and facilitate linkage with care is critically important,” Dr. Levenson, associate professor of psychiatry at Columbia University Irving Medical Center, New York, said during an annual psychopharmacology update held by the Nevada Psychiatric Association. “The vast majority of our workforce will thrive with proper support. But what can each of us do to take care of ourselves?”
Step one is to recognize common stress reactions as well as signs of distress. He offered the oxygen mask metaphor, the idea that before we can take care of and support anyone else, we must first take care of ourselves. “When people are stressed, they don’t always think about the oxygen mask metaphor,” Dr. Levenson said. Step two is to practice and model self-care by adopting principles often discussed in acceptance and commitment therapy: to focus on what you can control, not on what you can’t control.
“We can’t control the amount of toilet paper at the grocery store, how long the pandemic will last, or how others have reacted,” Dr. Levenson said. “We also can’t control other people’s motives, predict what will happen, or the actions of others, including whether they will follow social distancing guidelines or not.”
How about what we can control? One is a positive attitude, “which can sustain people during times of intense stress,” he said. “Other things that we can do include turn off the news and find fun and enriching activities to do at home, whether it be playing a game with family or reaching out to friends through an iPad or a smartphone. You can also follow [Centers for Disease Control and Prevention] recommendations, control your own social distancing, and limit social media activity, which can be stressful. We can also control our kindness and grace.” He added that resilience does not mean “snapping back” to how you were before the pandemic, but rather “learning to integrate the adverse experiences into who you are and growing with them, which is sometimes known as posttraumatic growth.”
Dr. Levenson encouraged health care workers to use their coping resources, connect to others, and cultivate their values and purpose in life as they navigate these challenging times. “You also want to promote realistic optimism; find a way to stay positive,” he said. “We emphasize to our staff that while you won’t forget this time, focus on what you can control – your positive relationships – and remind yourself of your values and sources of gratitude. Figure out, and reflect on, what you care about, and then care about it. Remind yourself in a deliberate, purposeful way what anchors you to your job, which in the health care setting tends to be a desire to care for others, to assist those in need, and to work in teams. We also encourage staff to refrain from judgment. Guilt is a normal and near-universal response to this stressor, but there are many ways to contribute without a judgmental or guilty tone.”
Other tips for self-support are to remind yourself that it is not selfish to take breaks. “The needs of your patients are not more important than your own needs,” Dr. Levenson said. “Working nonstop can put you at higher risk for stress, exhaustion, and illness. You may need to give yourself more time to step back and recover from workplace challenges or extended coverage for peers; this is important. We remind our staff that your work may feel more emotionally draining than usual because everything is more intense overall during the COVID-19 pandemic. This reminder helps staff normalize what they already may be experiencing, and in turn, to further support each other.”
Soothing activities to relieve stress include meditation, prayer, deep and slow breathing, relaxation exercises, yoga, mindfulness, stretching, staying hydrated, eating healthfully, exercise, and getting sufficient sleep. Other stress management tips include avoiding excessive alcohol intake, reaching out to others, asking for assistance, and delegating when possible. “We want to promote psychological flexibility: the ability to stay in contact with the present moment,” he said. “We encourage our peers to be aware of unpleasant thoughts and feelings, and to try to redirect negative thought patterns to a proactive problem-solving approach; this includes choosing one’s behaviors based on the situation and personal values.”
Dr. Levenson reported having no disclosures related to his presentation.
LAS VEGAS – according to Jon A. Levenson, MD.
“There are those who will need mental health treatment, so creating an easy way to reach out for help and facilitate linkage with care is critically important,” Dr. Levenson, associate professor of psychiatry at Columbia University Irving Medical Center, New York, said during an annual psychopharmacology update held by the Nevada Psychiatric Association. “The vast majority of our workforce will thrive with proper support. But what can each of us do to take care of ourselves?”
Step one is to recognize common stress reactions as well as signs of distress. He offered the oxygen mask metaphor, the idea that before we can take care of and support anyone else, we must first take care of ourselves. “When people are stressed, they don’t always think about the oxygen mask metaphor,” Dr. Levenson said. Step two is to practice and model self-care by adopting principles often discussed in acceptance and commitment therapy: to focus on what you can control, not on what you can’t control.
“We can’t control the amount of toilet paper at the grocery store, how long the pandemic will last, or how others have reacted,” Dr. Levenson said. “We also can’t control other people’s motives, predict what will happen, or the actions of others, including whether they will follow social distancing guidelines or not.”
How about what we can control? One is a positive attitude, “which can sustain people during times of intense stress,” he said. “Other things that we can do include turn off the news and find fun and enriching activities to do at home, whether it be playing a game with family or reaching out to friends through an iPad or a smartphone. You can also follow [Centers for Disease Control and Prevention] recommendations, control your own social distancing, and limit social media activity, which can be stressful. We can also control our kindness and grace.” He added that resilience does not mean “snapping back” to how you were before the pandemic, but rather “learning to integrate the adverse experiences into who you are and growing with them, which is sometimes known as posttraumatic growth.”
Dr. Levenson encouraged health care workers to use their coping resources, connect to others, and cultivate their values and purpose in life as they navigate these challenging times. “You also want to promote realistic optimism; find a way to stay positive,” he said. “We emphasize to our staff that while you won’t forget this time, focus on what you can control – your positive relationships – and remind yourself of your values and sources of gratitude. Figure out, and reflect on, what you care about, and then care about it. Remind yourself in a deliberate, purposeful way what anchors you to your job, which in the health care setting tends to be a desire to care for others, to assist those in need, and to work in teams. We also encourage staff to refrain from judgment. Guilt is a normal and near-universal response to this stressor, but there are many ways to contribute without a judgmental or guilty tone.”
Other tips for self-support are to remind yourself that it is not selfish to take breaks. “The needs of your patients are not more important than your own needs,” Dr. Levenson said. “Working nonstop can put you at higher risk for stress, exhaustion, and illness. You may need to give yourself more time to step back and recover from workplace challenges or extended coverage for peers; this is important. We remind our staff that your work may feel more emotionally draining than usual because everything is more intense overall during the COVID-19 pandemic. This reminder helps staff normalize what they already may be experiencing, and in turn, to further support each other.”
Soothing activities to relieve stress include meditation, prayer, deep and slow breathing, relaxation exercises, yoga, mindfulness, stretching, staying hydrated, eating healthfully, exercise, and getting sufficient sleep. Other stress management tips include avoiding excessive alcohol intake, reaching out to others, asking for assistance, and delegating when possible. “We want to promote psychological flexibility: the ability to stay in contact with the present moment,” he said. “We encourage our peers to be aware of unpleasant thoughts and feelings, and to try to redirect negative thought patterns to a proactive problem-solving approach; this includes choosing one’s behaviors based on the situation and personal values.”
Dr. Levenson reported having no disclosures related to his presentation.
AT NPA 2022
Tastier chocolate may be healthier chocolate
Chocolate: Now part of a well-balanced diet
Asking if someone loves chocolate is like asking if they love breathing. It’s really not a question that needs to be asked. The thing with chocolate, however, is that most people who love chocolate actually love sugar, since your typical milk chocolate contains only about 30% cacao. The rest, of course, is sugar.
Now, dark chocolate is actually kind of good for you since it contains beneficial flavonoids and less sugar. But that healthiness comes at a cost: Dark chocolate is quite bitter, and gets more so as the cacao content rises, to the point where 100% cacao chocolate is very nearly inedible. That’s the chocolate conundrum, the healthier it is, the worse it tastes. But what if there’s another way? What if you can have tasty chocolate that’s good for you?
That’s the question a group of researchers from Penn State University dared to ask. The secret, they discovered, is to subject the cacao beans to extra-intense roasting. We’re not sure how screaming insults at a bunch of beans will help, but if science says so ... YOU USELESS LUMP OF BARELY EDIBLE FOOD! HOW DARE YOU EXIST!
Oh, not that kind of roasting. Oops.
For their study, the researchers made 27 unsweetened chocolates, prepared using various cacao bean roasting times and temperatures, and served them to volunteers. Those volunteers reported that chocolates made with cacao beans roasted more intensely (such as 20 minutes at 340° F, 80 min at 275° F, and 54 min at 304° F) were far more acceptable than were chocolates prepared with raw or lightly roasted cacao beans.
The implications of healthy yet tasty chocolate are obvious: Master the chocolate and you’ll make millions. Imagine a future where parents say to their kids: “Don’t forget to eat your chocolate.” So, we’re off to do some cooking. Don’t want Hershey to make all the money off of this revelation.
The villain hiding in dairy for some MS patients
For some of us, lactose can be a real heartbreaker when it comes to dairy consumption, but for people with multiple sclerosis (MS) there’s another villain they may also have to face that can make their symptoms worse.
Physicians at the Institute of Anatomy at University Hospital Bonn (Germany) were getting so many complaints from patients with MS about how much worse they felt about after having cheese, yogurt, and milk that they decided to get to the bottom of it. The culprit, it seems, is casein, a protein specifically found in cow’s milk.
The researchers injected mice with various proteins found in cow’s milk and found perforated myelin sheaths in those given casein. In MS, the patient’s own immune system destroys that sheath, which leads to paresthesia, vision problems, and movement disorders.
“The body’s defenses actually attack the casein, but in the process they also destroy proteins involved in the formation of myelin, “ said Rittika Chunder, a postdoctoral fellow at the University of Bonn. How? Apparently it’s all a big misunderstanding.
While looking at molecules needed for myelin production, the researchers came across MAG, which is very similar to casein, which is a problem when patients with MS are allergic to casein. After they have dairy products, the B-cell squad gets called in to clean up the evil twin, casein, but can’t differentiate it from the good twin, MAG, so it all gets a wash and the myelin sheath suffers.
Since this happens only to patients with MS who have a casein allergy, the researchers advise them to stay away from milk, yogurt, or cottage cheese while they work on a self-test to check if patients carry the antibodies.
A small price to pay, perhaps, to stop a villainous evil twin.
You would even say it glows
If you’re anything like us – and we think you are since you’re reading this – you’ve been asking yourself: Are there any common medications in my house that will make good radiation sensors?
Not that anyone needs to worry about excess radiation or anything. Far from it. We were just wondering.
It just so happens that Anna Mrozik and Paweł Bilski, both of the Institute of Nuclear Physics Polish Academy of Sciences (IFJ PAN) in Kraków, Poland, were wondering the same thing: “During an uncontrolled release of radiation, it is highly unlikely that members of the public will be equipped with personal radiation dose monitors.”
People would need to use something they had lying around the house. A smartphone would work, the investigators explained in a statement from the IFJ PAN, but the process of converting one to radiation-sensor duty, which involves dismantling it and breaking the display glass, “is laborious and time-consuming [and] the destruction of a valuable and useful device does not seem to be the optimal solution.”
Naturally, they turned to drugs. The key, in this case, is optically stimulated luminescence. They needed to find materials that would glow with greater intensity as the radiation dose increased. Turns out that ibuprofen- and paracetamol-based painkillers fit the bill quite nicely, although aspirin also works.
It’s not known exactly which substance is causing the luminescence, but rest assured, the “physicists from the IFJ PAN intend to identify it.”
This is why you don’t interrupt someone using headphones
There’s nothing like taking a nice relaxing walk with your headphones. Whether you’re listening to a podcast or a song or talking on the phone, it’s an escape from reality that makes you feel like you’re completely in tune with what you’re listening to.
According to a new study, headphones, as opposed to speakers, make people feel more connected to what they are listening to. Data collected from more than 4,000 people showed that listening with headphones makes more of an impact than listening to speakers.
“Headphones produce a phenomenon called in-head localization, which makes the speaker sound as if they’re inside your head,” study coauthor On Amir of the University of California, San Diego, said in a statement. Because of this, people feel like the speakers are close to them and there’s more of a sense of empathy for the speakers and the listener is more likely to be swayed toward the ideas of the speaker.
These findings could lead to more efficient training programs, online work, and advertising, the investigators suggested.
We now finally understand why people get so mad when they have to take out their headphones to answer or talk to us. We ruined a satisfying moment going on in their brains.
Chocolate: Now part of a well-balanced diet
Asking if someone loves chocolate is like asking if they love breathing. It’s really not a question that needs to be asked. The thing with chocolate, however, is that most people who love chocolate actually love sugar, since your typical milk chocolate contains only about 30% cacao. The rest, of course, is sugar.
Now, dark chocolate is actually kind of good for you since it contains beneficial flavonoids and less sugar. But that healthiness comes at a cost: Dark chocolate is quite bitter, and gets more so as the cacao content rises, to the point where 100% cacao chocolate is very nearly inedible. That’s the chocolate conundrum, the healthier it is, the worse it tastes. But what if there’s another way? What if you can have tasty chocolate that’s good for you?
That’s the question a group of researchers from Penn State University dared to ask. The secret, they discovered, is to subject the cacao beans to extra-intense roasting. We’re not sure how screaming insults at a bunch of beans will help, but if science says so ... YOU USELESS LUMP OF BARELY EDIBLE FOOD! HOW DARE YOU EXIST!
Oh, not that kind of roasting. Oops.
For their study, the researchers made 27 unsweetened chocolates, prepared using various cacao bean roasting times and temperatures, and served them to volunteers. Those volunteers reported that chocolates made with cacao beans roasted more intensely (such as 20 minutes at 340° F, 80 min at 275° F, and 54 min at 304° F) were far more acceptable than were chocolates prepared with raw or lightly roasted cacao beans.
The implications of healthy yet tasty chocolate are obvious: Master the chocolate and you’ll make millions. Imagine a future where parents say to their kids: “Don’t forget to eat your chocolate.” So, we’re off to do some cooking. Don’t want Hershey to make all the money off of this revelation.
The villain hiding in dairy for some MS patients
For some of us, lactose can be a real heartbreaker when it comes to dairy consumption, but for people with multiple sclerosis (MS) there’s another villain they may also have to face that can make their symptoms worse.
Physicians at the Institute of Anatomy at University Hospital Bonn (Germany) were getting so many complaints from patients with MS about how much worse they felt about after having cheese, yogurt, and milk that they decided to get to the bottom of it. The culprit, it seems, is casein, a protein specifically found in cow’s milk.
The researchers injected mice with various proteins found in cow’s milk and found perforated myelin sheaths in those given casein. In MS, the patient’s own immune system destroys that sheath, which leads to paresthesia, vision problems, and movement disorders.
“The body’s defenses actually attack the casein, but in the process they also destroy proteins involved in the formation of myelin, “ said Rittika Chunder, a postdoctoral fellow at the University of Bonn. How? Apparently it’s all a big misunderstanding.
While looking at molecules needed for myelin production, the researchers came across MAG, which is very similar to casein, which is a problem when patients with MS are allergic to casein. After they have dairy products, the B-cell squad gets called in to clean up the evil twin, casein, but can’t differentiate it from the good twin, MAG, so it all gets a wash and the myelin sheath suffers.
Since this happens only to patients with MS who have a casein allergy, the researchers advise them to stay away from milk, yogurt, or cottage cheese while they work on a self-test to check if patients carry the antibodies.
A small price to pay, perhaps, to stop a villainous evil twin.
You would even say it glows
If you’re anything like us – and we think you are since you’re reading this – you’ve been asking yourself: Are there any common medications in my house that will make good radiation sensors?
Not that anyone needs to worry about excess radiation or anything. Far from it. We were just wondering.
It just so happens that Anna Mrozik and Paweł Bilski, both of the Institute of Nuclear Physics Polish Academy of Sciences (IFJ PAN) in Kraków, Poland, were wondering the same thing: “During an uncontrolled release of radiation, it is highly unlikely that members of the public will be equipped with personal radiation dose monitors.”
People would need to use something they had lying around the house. A smartphone would work, the investigators explained in a statement from the IFJ PAN, but the process of converting one to radiation-sensor duty, which involves dismantling it and breaking the display glass, “is laborious and time-consuming [and] the destruction of a valuable and useful device does not seem to be the optimal solution.”
Naturally, they turned to drugs. The key, in this case, is optically stimulated luminescence. They needed to find materials that would glow with greater intensity as the radiation dose increased. Turns out that ibuprofen- and paracetamol-based painkillers fit the bill quite nicely, although aspirin also works.
It’s not known exactly which substance is causing the luminescence, but rest assured, the “physicists from the IFJ PAN intend to identify it.”
This is why you don’t interrupt someone using headphones
There’s nothing like taking a nice relaxing walk with your headphones. Whether you’re listening to a podcast or a song or talking on the phone, it’s an escape from reality that makes you feel like you’re completely in tune with what you’re listening to.
According to a new study, headphones, as opposed to speakers, make people feel more connected to what they are listening to. Data collected from more than 4,000 people showed that listening with headphones makes more of an impact than listening to speakers.
“Headphones produce a phenomenon called in-head localization, which makes the speaker sound as if they’re inside your head,” study coauthor On Amir of the University of California, San Diego, said in a statement. Because of this, people feel like the speakers are close to them and there’s more of a sense of empathy for the speakers and the listener is more likely to be swayed toward the ideas of the speaker.
These findings could lead to more efficient training programs, online work, and advertising, the investigators suggested.
We now finally understand why people get so mad when they have to take out their headphones to answer or talk to us. We ruined a satisfying moment going on in their brains.
Chocolate: Now part of a well-balanced diet
Asking if someone loves chocolate is like asking if they love breathing. It’s really not a question that needs to be asked. The thing with chocolate, however, is that most people who love chocolate actually love sugar, since your typical milk chocolate contains only about 30% cacao. The rest, of course, is sugar.
Now, dark chocolate is actually kind of good for you since it contains beneficial flavonoids and less sugar. But that healthiness comes at a cost: Dark chocolate is quite bitter, and gets more so as the cacao content rises, to the point where 100% cacao chocolate is very nearly inedible. That’s the chocolate conundrum, the healthier it is, the worse it tastes. But what if there’s another way? What if you can have tasty chocolate that’s good for you?
That’s the question a group of researchers from Penn State University dared to ask. The secret, they discovered, is to subject the cacao beans to extra-intense roasting. We’re not sure how screaming insults at a bunch of beans will help, but if science says so ... YOU USELESS LUMP OF BARELY EDIBLE FOOD! HOW DARE YOU EXIST!
Oh, not that kind of roasting. Oops.
For their study, the researchers made 27 unsweetened chocolates, prepared using various cacao bean roasting times and temperatures, and served them to volunteers. Those volunteers reported that chocolates made with cacao beans roasted more intensely (such as 20 minutes at 340° F, 80 min at 275° F, and 54 min at 304° F) were far more acceptable than were chocolates prepared with raw or lightly roasted cacao beans.
The implications of healthy yet tasty chocolate are obvious: Master the chocolate and you’ll make millions. Imagine a future where parents say to their kids: “Don’t forget to eat your chocolate.” So, we’re off to do some cooking. Don’t want Hershey to make all the money off of this revelation.
The villain hiding in dairy for some MS patients
For some of us, lactose can be a real heartbreaker when it comes to dairy consumption, but for people with multiple sclerosis (MS) there’s another villain they may also have to face that can make their symptoms worse.
Physicians at the Institute of Anatomy at University Hospital Bonn (Germany) were getting so many complaints from patients with MS about how much worse they felt about after having cheese, yogurt, and milk that they decided to get to the bottom of it. The culprit, it seems, is casein, a protein specifically found in cow’s milk.
The researchers injected mice with various proteins found in cow’s milk and found perforated myelin sheaths in those given casein. In MS, the patient’s own immune system destroys that sheath, which leads to paresthesia, vision problems, and movement disorders.
“The body’s defenses actually attack the casein, but in the process they also destroy proteins involved in the formation of myelin, “ said Rittika Chunder, a postdoctoral fellow at the University of Bonn. How? Apparently it’s all a big misunderstanding.
While looking at molecules needed for myelin production, the researchers came across MAG, which is very similar to casein, which is a problem when patients with MS are allergic to casein. After they have dairy products, the B-cell squad gets called in to clean up the evil twin, casein, but can’t differentiate it from the good twin, MAG, so it all gets a wash and the myelin sheath suffers.
Since this happens only to patients with MS who have a casein allergy, the researchers advise them to stay away from milk, yogurt, or cottage cheese while they work on a self-test to check if patients carry the antibodies.
A small price to pay, perhaps, to stop a villainous evil twin.
You would even say it glows
If you’re anything like us – and we think you are since you’re reading this – you’ve been asking yourself: Are there any common medications in my house that will make good radiation sensors?
Not that anyone needs to worry about excess radiation or anything. Far from it. We were just wondering.
It just so happens that Anna Mrozik and Paweł Bilski, both of the Institute of Nuclear Physics Polish Academy of Sciences (IFJ PAN) in Kraków, Poland, were wondering the same thing: “During an uncontrolled release of radiation, it is highly unlikely that members of the public will be equipped with personal radiation dose monitors.”
People would need to use something they had lying around the house. A smartphone would work, the investigators explained in a statement from the IFJ PAN, but the process of converting one to radiation-sensor duty, which involves dismantling it and breaking the display glass, “is laborious and time-consuming [and] the destruction of a valuable and useful device does not seem to be the optimal solution.”
Naturally, they turned to drugs. The key, in this case, is optically stimulated luminescence. They needed to find materials that would glow with greater intensity as the radiation dose increased. Turns out that ibuprofen- and paracetamol-based painkillers fit the bill quite nicely, although aspirin also works.
It’s not known exactly which substance is causing the luminescence, but rest assured, the “physicists from the IFJ PAN intend to identify it.”
This is why you don’t interrupt someone using headphones
There’s nothing like taking a nice relaxing walk with your headphones. Whether you’re listening to a podcast or a song or talking on the phone, it’s an escape from reality that makes you feel like you’re completely in tune with what you’re listening to.
According to a new study, headphones, as opposed to speakers, make people feel more connected to what they are listening to. Data collected from more than 4,000 people showed that listening with headphones makes more of an impact than listening to speakers.
“Headphones produce a phenomenon called in-head localization, which makes the speaker sound as if they’re inside your head,” study coauthor On Amir of the University of California, San Diego, said in a statement. Because of this, people feel like the speakers are close to them and there’s more of a sense of empathy for the speakers and the listener is more likely to be swayed toward the ideas of the speaker.
These findings could lead to more efficient training programs, online work, and advertising, the investigators suggested.
We now finally understand why people get so mad when they have to take out their headphones to answer or talk to us. We ruined a satisfying moment going on in their brains.
FDA approves first drug for myelofibrosis with thrombocytopenia
Pacritinib (Vonjo, CTI BioPharma) is indicated for use in the treatment of adults with intermediate- or high-risk primary or secondary (post–polycythemia vera or post–essential thrombocythemia) myelofibrosis with a platelet count below 50 × 109/L.
Pacritinib is a novel oral kinase inhibitor with specificity for activity against Janus associated kinase 2 (JAK2) and IRAK1, without inhibiting JAK1. The recommended dosage is 200 mg orally twice daily.
In the United States, there are approximately 21,000 patients with myelofibrosis, notes the manufacturer. About one-third develop severe thrombocytopenia.
“Myelofibrosis with severe thrombocytopenia, defined as blood platelet counts below 50 × 109/L, has been shown to result in poor survival outcomes coupled with debilitating symptoms. Limited treatment options have rendered this disease as an area of urgent unmet medical need,” said John Mascarenhas, MD, associate professor, medicine, hematology, and medical oncology, Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York.
“I am pleased to see that a new, efficacious, and safe treatment option is now available for these patients,” he said in a company press release.
Dr. Mascarenhas was the lead investigator of the phase 3 PERSIST-2 trial that was the basis for the approval. Results from the trial were published in 2018 in JAMA Oncology and reported in detail at the time by this news organization.
Authors of an accompanying editorial noted the trial was truncated after the FDA imposed a clinical hold on pacritinib in February 2016 after reports from an earlier trial, PERSIST-1, of patient deaths related to cardiac failure and arrest as well as intracranial hemorrhage. The clinical hold was lifted in January 2017 after the manufacturer provided the FDA with more mature data.
Despite the truncation, the PERSIST-2 trial provided sufficient data to obtain accelerated approval for the drug. The study compared pacritinib with best available therapy (BAT).
In the cohort of patients treated with pacritinib 200 mg twice daily, 29% of patients had a reduction in spleen volume of at least 35% compared with 3% of patients receiving BAT, which included ruxolitinib.
The company is now expected to demonstrate clinical benefit in a confirmatory trial and has the PACIFICA trial underway. Results are expected in mid-2025.
The most common adverse reactions (reported by ≥ 20% of patients) were diarrhea, thrombocytopenia, nausea, anemia, and peripheral edema. The most frequent serious adverse reactions (≥ 3%) were anemia, thrombocytopenia, pneumonia, cardiac failure, disease progression, pyrexia, and squamous cell carcinoma of the skin.
A version of this article first appeared on Medscape.com.
Pacritinib (Vonjo, CTI BioPharma) is indicated for use in the treatment of adults with intermediate- or high-risk primary or secondary (post–polycythemia vera or post–essential thrombocythemia) myelofibrosis with a platelet count below 50 × 109/L.
Pacritinib is a novel oral kinase inhibitor with specificity for activity against Janus associated kinase 2 (JAK2) and IRAK1, without inhibiting JAK1. The recommended dosage is 200 mg orally twice daily.
In the United States, there are approximately 21,000 patients with myelofibrosis, notes the manufacturer. About one-third develop severe thrombocytopenia.
“Myelofibrosis with severe thrombocytopenia, defined as blood platelet counts below 50 × 109/L, has been shown to result in poor survival outcomes coupled with debilitating symptoms. Limited treatment options have rendered this disease as an area of urgent unmet medical need,” said John Mascarenhas, MD, associate professor, medicine, hematology, and medical oncology, Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York.
“I am pleased to see that a new, efficacious, and safe treatment option is now available for these patients,” he said in a company press release.
Dr. Mascarenhas was the lead investigator of the phase 3 PERSIST-2 trial that was the basis for the approval. Results from the trial were published in 2018 in JAMA Oncology and reported in detail at the time by this news organization.
Authors of an accompanying editorial noted the trial was truncated after the FDA imposed a clinical hold on pacritinib in February 2016 after reports from an earlier trial, PERSIST-1, of patient deaths related to cardiac failure and arrest as well as intracranial hemorrhage. The clinical hold was lifted in January 2017 after the manufacturer provided the FDA with more mature data.
Despite the truncation, the PERSIST-2 trial provided sufficient data to obtain accelerated approval for the drug. The study compared pacritinib with best available therapy (BAT).
In the cohort of patients treated with pacritinib 200 mg twice daily, 29% of patients had a reduction in spleen volume of at least 35% compared with 3% of patients receiving BAT, which included ruxolitinib.
The company is now expected to demonstrate clinical benefit in a confirmatory trial and has the PACIFICA trial underway. Results are expected in mid-2025.
The most common adverse reactions (reported by ≥ 20% of patients) were diarrhea, thrombocytopenia, nausea, anemia, and peripheral edema. The most frequent serious adverse reactions (≥ 3%) were anemia, thrombocytopenia, pneumonia, cardiac failure, disease progression, pyrexia, and squamous cell carcinoma of the skin.
A version of this article first appeared on Medscape.com.
Pacritinib (Vonjo, CTI BioPharma) is indicated for use in the treatment of adults with intermediate- or high-risk primary or secondary (post–polycythemia vera or post–essential thrombocythemia) myelofibrosis with a platelet count below 50 × 109/L.
Pacritinib is a novel oral kinase inhibitor with specificity for activity against Janus associated kinase 2 (JAK2) and IRAK1, without inhibiting JAK1. The recommended dosage is 200 mg orally twice daily.
In the United States, there are approximately 21,000 patients with myelofibrosis, notes the manufacturer. About one-third develop severe thrombocytopenia.
“Myelofibrosis with severe thrombocytopenia, defined as blood platelet counts below 50 × 109/L, has been shown to result in poor survival outcomes coupled with debilitating symptoms. Limited treatment options have rendered this disease as an area of urgent unmet medical need,” said John Mascarenhas, MD, associate professor, medicine, hematology, and medical oncology, Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York.
“I am pleased to see that a new, efficacious, and safe treatment option is now available for these patients,” he said in a company press release.
Dr. Mascarenhas was the lead investigator of the phase 3 PERSIST-2 trial that was the basis for the approval. Results from the trial were published in 2018 in JAMA Oncology and reported in detail at the time by this news organization.
Authors of an accompanying editorial noted the trial was truncated after the FDA imposed a clinical hold on pacritinib in February 2016 after reports from an earlier trial, PERSIST-1, of patient deaths related to cardiac failure and arrest as well as intracranial hemorrhage. The clinical hold was lifted in January 2017 after the manufacturer provided the FDA with more mature data.
Despite the truncation, the PERSIST-2 trial provided sufficient data to obtain accelerated approval for the drug. The study compared pacritinib with best available therapy (BAT).
In the cohort of patients treated with pacritinib 200 mg twice daily, 29% of patients had a reduction in spleen volume of at least 35% compared with 3% of patients receiving BAT, which included ruxolitinib.
The company is now expected to demonstrate clinical benefit in a confirmatory trial and has the PACIFICA trial underway. Results are expected in mid-2025.
The most common adverse reactions (reported by ≥ 20% of patients) were diarrhea, thrombocytopenia, nausea, anemia, and peripheral edema. The most frequent serious adverse reactions (≥ 3%) were anemia, thrombocytopenia, pneumonia, cardiac failure, disease progression, pyrexia, and squamous cell carcinoma of the skin.
A version of this article first appeared on Medscape.com.
FDA approves new CAR T-cell treatment for multiple myeloma
A new treatment option for patients with refractory/relapsed multiple myeloma who have already tried four or more therapies has been approved by the U.S. Food and Drug Administration.
There are already two other therapies on the market that target BCMA – another CAR T cell, idecabtagene vicleucel (Abecma), which was approved by the FDA in March 2021, and a drug conjugate, belantamab mafodotin (Blenrep), which was approved in August 2020.
The approval of cilta-cel was based on clinical data from the CARTITUDE-1 study, which were initially presented in December 2020 at the annual meeting of the American Society of Hematology, as reported at the time by this news organization.
The trial involved 97 patients with relapsed/refractory multiple myeloma who had already received a median of six previous treatments (range, three to 18), including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
“The treatment journey for the majority of patients living with multiple myeloma is a relentless cycle of remission and relapse, with fewer patients achieving a deep response as they progress through later lines of therapy,” commented Sundar Jagannath, MBBS, professor of medicine, hematology, and medical oncology at Mount Sinai, who was a principal investigator on the pivotal study.
“That is why I have been really excited about the results from the CARTITUDE-1 study, which has demonstrated that cilta-cel can provide deep and durable responses and long-term treatment-free intervals, even in this heavily pretreated multiple myeloma patient population,” he said.
“Today’s approval of Carvykti helps address a great unmet need for these patients,” he commented in a press release from the manufacturer.
Like other CAR T-cell therapies, ciltacabtagene autoleucel is a one-time treatment. It involves collecting blood from the patient, extracting T cells, genetically engineering them, then transfusing them back to the patient, who in the meantime has undergone conditioning.
The results from CARTITUDE-1 show that this one-time treatment resulted in deep and durable responses.
The overall response rate was 98%, and the majority of patients (78%) achieved a stringent complete response, in which physicians are unable to observe any signs or symptoms of disease via imaging or other tests after treatment.
At a median of 18 months’ follow-up, the median duration of response was 21.8 months.
“The responses in the CARTITUDE-1 study showed durability over time and resulted in the majority of heavily pretreated patients achieving deep responses after 18-month follow-up,” commented Mr. Jagannath.
“The approval of cilta-cel provides physicians an immunotherapy treatment option that offers patients an opportunity to be free from anti-myeloma therapies for a period of time,” he added.
As with other CAR T-cell therapies, there were serious side effects, and these products are available only through restricted programs under a risk evaluation and mitigation strategy.
The product information for Cartykti includes a boxed warning that mentions cytokine release syndrome (CRS), immune effector cell–associated neurotoxicity syndrome, parkinsonism, Guillain-Barré syndrome, hemophagocytic lymphohistiocytosis/macrophage activation syndrome, and prolonged and/or recurrent cytopenias.
The most common adverse reactions (reported in greater than or equal to 20% of patients) are pyrexia, CRS, hypogammaglobulinemia, hypotension, musculoskeletal pain, fatigue, infections–pathogens unspecified, cough, chills, diarrhea, nausea, encephalopathy, decreased appetite, upper respiratory tract infection, headache, tachycardia, dizziness, dyspnea, edema, viral infections, coagulopathy, constipation, and vomiting.
A version of this article first appeared on Medscape.com.
A new treatment option for patients with refractory/relapsed multiple myeloma who have already tried four or more therapies has been approved by the U.S. Food and Drug Administration.
There are already two other therapies on the market that target BCMA – another CAR T cell, idecabtagene vicleucel (Abecma), which was approved by the FDA in March 2021, and a drug conjugate, belantamab mafodotin (Blenrep), which was approved in August 2020.
The approval of cilta-cel was based on clinical data from the CARTITUDE-1 study, which were initially presented in December 2020 at the annual meeting of the American Society of Hematology, as reported at the time by this news organization.
The trial involved 97 patients with relapsed/refractory multiple myeloma who had already received a median of six previous treatments (range, three to 18), including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
“The treatment journey for the majority of patients living with multiple myeloma is a relentless cycle of remission and relapse, with fewer patients achieving a deep response as they progress through later lines of therapy,” commented Sundar Jagannath, MBBS, professor of medicine, hematology, and medical oncology at Mount Sinai, who was a principal investigator on the pivotal study.
“That is why I have been really excited about the results from the CARTITUDE-1 study, which has demonstrated that cilta-cel can provide deep and durable responses and long-term treatment-free intervals, even in this heavily pretreated multiple myeloma patient population,” he said.
“Today’s approval of Carvykti helps address a great unmet need for these patients,” he commented in a press release from the manufacturer.
Like other CAR T-cell therapies, ciltacabtagene autoleucel is a one-time treatment. It involves collecting blood from the patient, extracting T cells, genetically engineering them, then transfusing them back to the patient, who in the meantime has undergone conditioning.
The results from CARTITUDE-1 show that this one-time treatment resulted in deep and durable responses.
The overall response rate was 98%, and the majority of patients (78%) achieved a stringent complete response, in which physicians are unable to observe any signs or symptoms of disease via imaging or other tests after treatment.
At a median of 18 months’ follow-up, the median duration of response was 21.8 months.
“The responses in the CARTITUDE-1 study showed durability over time and resulted in the majority of heavily pretreated patients achieving deep responses after 18-month follow-up,” commented Mr. Jagannath.
“The approval of cilta-cel provides physicians an immunotherapy treatment option that offers patients an opportunity to be free from anti-myeloma therapies for a period of time,” he added.
As with other CAR T-cell therapies, there were serious side effects, and these products are available only through restricted programs under a risk evaluation and mitigation strategy.
The product information for Cartykti includes a boxed warning that mentions cytokine release syndrome (CRS), immune effector cell–associated neurotoxicity syndrome, parkinsonism, Guillain-Barré syndrome, hemophagocytic lymphohistiocytosis/macrophage activation syndrome, and prolonged and/or recurrent cytopenias.
The most common adverse reactions (reported in greater than or equal to 20% of patients) are pyrexia, CRS, hypogammaglobulinemia, hypotension, musculoskeletal pain, fatigue, infections–pathogens unspecified, cough, chills, diarrhea, nausea, encephalopathy, decreased appetite, upper respiratory tract infection, headache, tachycardia, dizziness, dyspnea, edema, viral infections, coagulopathy, constipation, and vomiting.
A version of this article first appeared on Medscape.com.
A new treatment option for patients with refractory/relapsed multiple myeloma who have already tried four or more therapies has been approved by the U.S. Food and Drug Administration.
There are already two other therapies on the market that target BCMA – another CAR T cell, idecabtagene vicleucel (Abecma), which was approved by the FDA in March 2021, and a drug conjugate, belantamab mafodotin (Blenrep), which was approved in August 2020.
The approval of cilta-cel was based on clinical data from the CARTITUDE-1 study, which were initially presented in December 2020 at the annual meeting of the American Society of Hematology, as reported at the time by this news organization.
The trial involved 97 patients with relapsed/refractory multiple myeloma who had already received a median of six previous treatments (range, three to 18), including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
“The treatment journey for the majority of patients living with multiple myeloma is a relentless cycle of remission and relapse, with fewer patients achieving a deep response as they progress through later lines of therapy,” commented Sundar Jagannath, MBBS, professor of medicine, hematology, and medical oncology at Mount Sinai, who was a principal investigator on the pivotal study.
“That is why I have been really excited about the results from the CARTITUDE-1 study, which has demonstrated that cilta-cel can provide deep and durable responses and long-term treatment-free intervals, even in this heavily pretreated multiple myeloma patient population,” he said.
“Today’s approval of Carvykti helps address a great unmet need for these patients,” he commented in a press release from the manufacturer.
Like other CAR T-cell therapies, ciltacabtagene autoleucel is a one-time treatment. It involves collecting blood from the patient, extracting T cells, genetically engineering them, then transfusing them back to the patient, who in the meantime has undergone conditioning.
The results from CARTITUDE-1 show that this one-time treatment resulted in deep and durable responses.
The overall response rate was 98%, and the majority of patients (78%) achieved a stringent complete response, in which physicians are unable to observe any signs or symptoms of disease via imaging or other tests after treatment.
At a median of 18 months’ follow-up, the median duration of response was 21.8 months.
“The responses in the CARTITUDE-1 study showed durability over time and resulted in the majority of heavily pretreated patients achieving deep responses after 18-month follow-up,” commented Mr. Jagannath.
“The approval of cilta-cel provides physicians an immunotherapy treatment option that offers patients an opportunity to be free from anti-myeloma therapies for a period of time,” he added.
As with other CAR T-cell therapies, there were serious side effects, and these products are available only through restricted programs under a risk evaluation and mitigation strategy.
The product information for Cartykti includes a boxed warning that mentions cytokine release syndrome (CRS), immune effector cell–associated neurotoxicity syndrome, parkinsonism, Guillain-Barré syndrome, hemophagocytic lymphohistiocytosis/macrophage activation syndrome, and prolonged and/or recurrent cytopenias.
The most common adverse reactions (reported in greater than or equal to 20% of patients) are pyrexia, CRS, hypogammaglobulinemia, hypotension, musculoskeletal pain, fatigue, infections–pathogens unspecified, cough, chills, diarrhea, nausea, encephalopathy, decreased appetite, upper respiratory tract infection, headache, tachycardia, dizziness, dyspnea, edema, viral infections, coagulopathy, constipation, and vomiting.
A version of this article first appeared on Medscape.com.
COVID-19 vaccines do not trigger sudden hearing loss: Study
Anecdotal reports have linked the vaccines against COVID-19 to the sudden loss of hearing in some people. But a new study has found no evidence for such a connection with any of the three approved shots.
The analysis of data from the Centers for Disease Control and Prevention’s Vaccine Adverse Event Reporting System (VAERS) found that
“We’re not finding a signal,” said Eric J. Formeister, MD, a neurotology fellow at the Johns Hopkins University, Baltimore, and the first author of the U.S. study, which appeared Feb. 24 in JAMA Otolaryngology – Head and Neck Surgery.
Dr. Formeister and colleagues undertook the study in response to reports of hearing problems, including hearing loss and tinnitus, that occurred soon after COVID-19 vaccination.
They analyzed reports of sudden hearing loss, experienced within 21 days of vaccination, logged in VAERS. Anyone can report a potential event to the database, which does not require medical documentation in support of the adverse event. To minimize potential misdiagnoses, Dr. Formeister and colleagues reviewed only those reports that indicated that a doctor had diagnosed sudden hearing loss, leaving 555 cases (305 in women; mean age 54 years) between December 2020 and July 2021.
Dividing these reports by the total doses of vaccines administered in the United States during that period yielded an incidence rate of 0.6 cases of sudden hearing loss for every 100,000 people, Dr. Formeister and colleagues reported.
When the researchers divided all cases of hearing loss in the VAERS database (2,170) by the number of people who had received two doses of vaccine, the incidence rate increased to 28 per 100,000 people. For comparison, the authors reported, the incidence of sudden hearing loss within the United States population is between 11 and 77 per 100,000 people, depending on age.
“There was not an increase in cases of sudden [sensorineural] hearing loss associated with COVID-19 vaccination compared to previously published reports before the COVID-19 vaccination era,” study coauthor Elliott D. Kozin, MD, assistant professor of otolaryngology–head and neck surgery at Harvard Medical School, Boston, said in an interview.
Another reassuring sign: If hearing loss were linked to the vaccines, the researchers said, they would expect to see an increase in the number of complaints in lockstep with an increase in the number of doses administered. However, the opposite was true. “[T]he rate of reports per 100,000 doses decreased across the vaccination period, despite large concomitant increases in the absolute number of vaccine doses administered per week,” the researchers reported.
They also looked at case reports of 21 men and women who had experienced sudden hearing loss after having received COVID-19 vaccines, to see if they could discern any clinically relevant signs of people most likely to experience the adverse event. However, the group had a range of preexisting conditions and varying times after receiving a vaccine when their hearing loss occurred, leading Dr. Formeister’s team to conclude that they could find no clear markers of risk.
“When we examined patients across several institutions, there was no obvious pattern. The patient demographics and clinical findings were variable,” Dr. Kozin said. A provisional interpretation of this data, he added, is that no link exists between COVID-19 vaccination and predictable hearing deficits, although the analysis covered a small number of patients.
“Association does not necessarily imply a causal relationship,” said Michael Brenner, MD, FACS, associate professor of otolaryngology–head and neck surgery at the University of Michigan, Ann Arbor. Dr. Brenner, who was not involved in the study, said any hearing loss attributed to the COVID-19 vaccines could have had other causes besides the injections.
But a second study, also published in JAMA Otolaryngology – Head and Neck Surgery on Feb. 24, leaves open the possibility of a link. Researchers in Israel looked for increases in steroid prescriptions used to treat sudden hearing loss as vaccination with the Pfizer version of the shot became widespread in that country. Their conclusion: The vaccine might be associated with a slightly increased risk of sudden hearing loss, although if so, that risk is likely “very small” and the benefits of vaccination “outweigh its potential association” with the side effect.
Dr. Brenner agreed. “The evidence supports [the] clear public health benefit of COVID-19 vaccination, and the scale of those benefits dwarfs associations with hearing, which are of uncertain significance,” he said.
A version of this article first appeared on Medscape.com.
Anecdotal reports have linked the vaccines against COVID-19 to the sudden loss of hearing in some people. But a new study has found no evidence for such a connection with any of the three approved shots.
The analysis of data from the Centers for Disease Control and Prevention’s Vaccine Adverse Event Reporting System (VAERS) found that
“We’re not finding a signal,” said Eric J. Formeister, MD, a neurotology fellow at the Johns Hopkins University, Baltimore, and the first author of the U.S. study, which appeared Feb. 24 in JAMA Otolaryngology – Head and Neck Surgery.
Dr. Formeister and colleagues undertook the study in response to reports of hearing problems, including hearing loss and tinnitus, that occurred soon after COVID-19 vaccination.
They analyzed reports of sudden hearing loss, experienced within 21 days of vaccination, logged in VAERS. Anyone can report a potential event to the database, which does not require medical documentation in support of the adverse event. To minimize potential misdiagnoses, Dr. Formeister and colleagues reviewed only those reports that indicated that a doctor had diagnosed sudden hearing loss, leaving 555 cases (305 in women; mean age 54 years) between December 2020 and July 2021.
Dividing these reports by the total doses of vaccines administered in the United States during that period yielded an incidence rate of 0.6 cases of sudden hearing loss for every 100,000 people, Dr. Formeister and colleagues reported.
When the researchers divided all cases of hearing loss in the VAERS database (2,170) by the number of people who had received two doses of vaccine, the incidence rate increased to 28 per 100,000 people. For comparison, the authors reported, the incidence of sudden hearing loss within the United States population is between 11 and 77 per 100,000 people, depending on age.
“There was not an increase in cases of sudden [sensorineural] hearing loss associated with COVID-19 vaccination compared to previously published reports before the COVID-19 vaccination era,” study coauthor Elliott D. Kozin, MD, assistant professor of otolaryngology–head and neck surgery at Harvard Medical School, Boston, said in an interview.
Another reassuring sign: If hearing loss were linked to the vaccines, the researchers said, they would expect to see an increase in the number of complaints in lockstep with an increase in the number of doses administered. However, the opposite was true. “[T]he rate of reports per 100,000 doses decreased across the vaccination period, despite large concomitant increases in the absolute number of vaccine doses administered per week,” the researchers reported.
They also looked at case reports of 21 men and women who had experienced sudden hearing loss after having received COVID-19 vaccines, to see if they could discern any clinically relevant signs of people most likely to experience the adverse event. However, the group had a range of preexisting conditions and varying times after receiving a vaccine when their hearing loss occurred, leading Dr. Formeister’s team to conclude that they could find no clear markers of risk.
“When we examined patients across several institutions, there was no obvious pattern. The patient demographics and clinical findings were variable,” Dr. Kozin said. A provisional interpretation of this data, he added, is that no link exists between COVID-19 vaccination and predictable hearing deficits, although the analysis covered a small number of patients.
“Association does not necessarily imply a causal relationship,” said Michael Brenner, MD, FACS, associate professor of otolaryngology–head and neck surgery at the University of Michigan, Ann Arbor. Dr. Brenner, who was not involved in the study, said any hearing loss attributed to the COVID-19 vaccines could have had other causes besides the injections.
But a second study, also published in JAMA Otolaryngology – Head and Neck Surgery on Feb. 24, leaves open the possibility of a link. Researchers in Israel looked for increases in steroid prescriptions used to treat sudden hearing loss as vaccination with the Pfizer version of the shot became widespread in that country. Their conclusion: The vaccine might be associated with a slightly increased risk of sudden hearing loss, although if so, that risk is likely “very small” and the benefits of vaccination “outweigh its potential association” with the side effect.
Dr. Brenner agreed. “The evidence supports [the] clear public health benefit of COVID-19 vaccination, and the scale of those benefits dwarfs associations with hearing, which are of uncertain significance,” he said.
A version of this article first appeared on Medscape.com.
Anecdotal reports have linked the vaccines against COVID-19 to the sudden loss of hearing in some people. But a new study has found no evidence for such a connection with any of the three approved shots.
The analysis of data from the Centers for Disease Control and Prevention’s Vaccine Adverse Event Reporting System (VAERS) found that
“We’re not finding a signal,” said Eric J. Formeister, MD, a neurotology fellow at the Johns Hopkins University, Baltimore, and the first author of the U.S. study, which appeared Feb. 24 in JAMA Otolaryngology – Head and Neck Surgery.
Dr. Formeister and colleagues undertook the study in response to reports of hearing problems, including hearing loss and tinnitus, that occurred soon after COVID-19 vaccination.
They analyzed reports of sudden hearing loss, experienced within 21 days of vaccination, logged in VAERS. Anyone can report a potential event to the database, which does not require medical documentation in support of the adverse event. To minimize potential misdiagnoses, Dr. Formeister and colleagues reviewed only those reports that indicated that a doctor had diagnosed sudden hearing loss, leaving 555 cases (305 in women; mean age 54 years) between December 2020 and July 2021.
Dividing these reports by the total doses of vaccines administered in the United States during that period yielded an incidence rate of 0.6 cases of sudden hearing loss for every 100,000 people, Dr. Formeister and colleagues reported.
When the researchers divided all cases of hearing loss in the VAERS database (2,170) by the number of people who had received two doses of vaccine, the incidence rate increased to 28 per 100,000 people. For comparison, the authors reported, the incidence of sudden hearing loss within the United States population is between 11 and 77 per 100,000 people, depending on age.
“There was not an increase in cases of sudden [sensorineural] hearing loss associated with COVID-19 vaccination compared to previously published reports before the COVID-19 vaccination era,” study coauthor Elliott D. Kozin, MD, assistant professor of otolaryngology–head and neck surgery at Harvard Medical School, Boston, said in an interview.
Another reassuring sign: If hearing loss were linked to the vaccines, the researchers said, they would expect to see an increase in the number of complaints in lockstep with an increase in the number of doses administered. However, the opposite was true. “[T]he rate of reports per 100,000 doses decreased across the vaccination period, despite large concomitant increases in the absolute number of vaccine doses administered per week,” the researchers reported.
They also looked at case reports of 21 men and women who had experienced sudden hearing loss after having received COVID-19 vaccines, to see if they could discern any clinically relevant signs of people most likely to experience the adverse event. However, the group had a range of preexisting conditions and varying times after receiving a vaccine when their hearing loss occurred, leading Dr. Formeister’s team to conclude that they could find no clear markers of risk.
“When we examined patients across several institutions, there was no obvious pattern. The patient demographics and clinical findings were variable,” Dr. Kozin said. A provisional interpretation of this data, he added, is that no link exists between COVID-19 vaccination and predictable hearing deficits, although the analysis covered a small number of patients.
“Association does not necessarily imply a causal relationship,” said Michael Brenner, MD, FACS, associate professor of otolaryngology–head and neck surgery at the University of Michigan, Ann Arbor. Dr. Brenner, who was not involved in the study, said any hearing loss attributed to the COVID-19 vaccines could have had other causes besides the injections.
But a second study, also published in JAMA Otolaryngology – Head and Neck Surgery on Feb. 24, leaves open the possibility of a link. Researchers in Israel looked for increases in steroid prescriptions used to treat sudden hearing loss as vaccination with the Pfizer version of the shot became widespread in that country. Their conclusion: The vaccine might be associated with a slightly increased risk of sudden hearing loss, although if so, that risk is likely “very small” and the benefits of vaccination “outweigh its potential association” with the side effect.
Dr. Brenner agreed. “The evidence supports [the] clear public health benefit of COVID-19 vaccination, and the scale of those benefits dwarfs associations with hearing, which are of uncertain significance,” he said.
A version of this article first appeared on Medscape.com.
FROM JAMA OTOLARYNGOLOGY – HEAD AND NECK SURGERY
Why challenging patients can trigger resentment
I have a secret. It’s one I think many physicians and nurses share. Sometimes, when I’m stretched too thin — overbooked, hungry, tired, fielding yet another appeal to an insurance company in the middle of a clinic day —
As soon as this happens, I feel immediate guilt. These are the worst moments of my day. Why the heck would I resent my patients? They’re the entire reason I’m there. I wouldn’t be a physician without patients to care for. I became a physician, and completed subspecialty training, to help patients. People.
Recently, I started thinking more about this emotion of resentment. What exactly is it, and where does it come from? Is what I’m feeling actually resentment? Or is it something else?
Two books I’ve recently read have helped me explore the complicated emotion of resentment and how it might play a role in burnout for both physicians and nurses.
First, Brené Brown’s most recent book, Atlas of the Heart: Mapping Meaningful Connection and the Language of Human Experience, provides a roadmap for 87 of our human emotions. (That’s right — 87!)
One emotion of the 87 that she shares has been a particular struggle for her has been our good old friend, resentment.
In her book, Dr Brown shares that she initially considered resentment to belong to the anger family of emotion. As I read this, I agreed. When I feel resentful, I associate that with feeling angry.
But she then writes about her discovery that resentment, in fact, belongs to the envy family. She explains how this discovery shook her world. I had to close the book for a moment at this point.
Wait a minute, I thought. If resentment is in the envy family, why do we (physicians) often find ourselves resenting patients who take up our time? What are we envious of?
I took some time to think about how this might be true. Could it be that I’m envious they have the time I don’t have? I want to have all the time in the world to answer their questions, but the reality is I don’t.
Or maybe it’s because sometimes I feel the patient is expecting me to offer them something more than is available. A cure when there might be none.
But is this actually true? Or is this my unrealistic expectation of myself?
Here’s how Brené Brown defines resentment in her book: “Resentment is the feeling of frustration, judgment, anger, ‘better than,’ and/or hidden envy related to perceived unfairness or injustice. It’s an emotion that we often experience when we fail to set boundaries or ask for what we need, or when expectations let us down because they were based on things we can’t control, like what other people think, what they feel, or how they’re going to react.”
Wow, I thought, Healthcare checks all of these boxes.
- Perceived unfairness of work schedules? Check.
- Perceived injustice? Of course — we see that in our dealings with insurance company denials every day.
But those are both extrinsic. What about the intrinsic factors she’s calling us out on here?
- Do we, as physicians, fail to set boundaries?
- Do we fail to ask for what we need?
Hard yes and yes. (Do we even know, as physicians, what our own boundaries are?)
And the last one:
- Do our expectations of how our clinic day will go let us down every day because they’re based on things we can’t control?
My brain had to repeat the critical parts of that: Expectations let us down when they’re based on things we can’t control.
But wait, my brain argued back; I’m the physician, I thought I was supposed to get to control things.
Next, the revelation: Could it be that a key to experiencing less resentment is accepting how much control we don’t have in a typical day?
And a corollary: How much does resentment factor into burnout? (To read more on my personal journey with burnout, see this piece).
It so happens that around this same time, I was reading another excellent book, Changing How We Think About Difficult Patients: A Guide for Physicians and Healthcare Professionals, by Joan Naidorf, DO.
Dr Naidorf is an emergency medicine physician of 30 years who wrote the book to “provid[e] insight and tools to manage our negative thoughts about difficult patients” and help “beleaguered colleagues…return to their benevolent guiding principles and find more enjoyment in their vitally important careers.”
As I read Dr Naidorf’s book, I thus did so with the mindset of wanting to further understand for myself where this specific emotion of resentment toward our “difficult” patients could come from and how to best understand it in order to get past it.
Dr. Naidorf writes, “Challenging patients will never stop appearing… You cannot change them or control them—the only person you can control is you.”
I wondered how much the resentment we might involuntarily feel at being asked to see a “difficult” patient has nothing to do with the patient but everything to do with it making us feel not in control of the situation.
Dr. Naidorf also writes, “Negative thoughts about challenging patients can cause, in otherwise capable clinicians, a sense of inadequacy and incompetence.”
Do we perhaps resent our challenging patients because of the negative thoughts they sometimes trigger in us? If so, how does this relate to envy, as Dr. Brown asserts resentment is tied to? Is it triggering us to feel inadequate?
“[Difficult patients] often make us question ourselves,” Dr. Naidorf writes, “and we need to feel comfortable with the answers.”
Again, the discrepancy between expectations and reality creates the negative emotion.
Or, as Dr. Naidorf writes, “What if you could stop judging others so harshly and accept them exactly as they are?”
Hmmm, I thought, then the cessation of harsh judgment and implementation of acceptance would have to apply to us too. The elusive concept of self-compassion.
Maybe the resentment/envy comes from us not allowing ourselves to behave in this way because to do so would allow too much vulnerability. Something most of us were conditioned to avoid to survive medical training.
Dr. Brown also writes about an “aha” moment she had in her struggle to understand resentment. “I’m not mad because you’re resting. I’m mad because I’m so bone tired and I want to rest. But, unlike you, I’m going to pretend that I don’t need to.”
I felt all too seen in that passage. Could it be my old nemesis, perfectionism, creeping its way back in? Is resentment the ugly stepsister to perfectionism?
Perhaps challenging patients can engender resentment because they make us feel like we’re not living up to our own unrealistic expectations. And in that case, we need to change our unrealistic expectations for ourselves.
Dr Naidorf’s book explores much more on the complex matter of what makes a “difficult” patient, but I chose to focus here only on the resentment piece as a tie-in to Dr. Brown’s book. I highly recommend both books for further reading to help physicians and nurses navigate the complex emotions our jobs can trigger.
Most importantly, recognizing that we have these transient negative emotions does not make us bad people or healthcare professionals. It only makes us human.
Dr. Lycette is medical director, Providence Oncology and Hematology Care Clinic, Seaside, Ore. She has disclosed having no relevant financial relationships.
A version of this article first appeared on Medscape.com.
I have a secret. It’s one I think many physicians and nurses share. Sometimes, when I’m stretched too thin — overbooked, hungry, tired, fielding yet another appeal to an insurance company in the middle of a clinic day —
As soon as this happens, I feel immediate guilt. These are the worst moments of my day. Why the heck would I resent my patients? They’re the entire reason I’m there. I wouldn’t be a physician without patients to care for. I became a physician, and completed subspecialty training, to help patients. People.
Recently, I started thinking more about this emotion of resentment. What exactly is it, and where does it come from? Is what I’m feeling actually resentment? Or is it something else?
Two books I’ve recently read have helped me explore the complicated emotion of resentment and how it might play a role in burnout for both physicians and nurses.
First, Brené Brown’s most recent book, Atlas of the Heart: Mapping Meaningful Connection and the Language of Human Experience, provides a roadmap for 87 of our human emotions. (That’s right — 87!)
One emotion of the 87 that she shares has been a particular struggle for her has been our good old friend, resentment.
In her book, Dr Brown shares that she initially considered resentment to belong to the anger family of emotion. As I read this, I agreed. When I feel resentful, I associate that with feeling angry.
But she then writes about her discovery that resentment, in fact, belongs to the envy family. She explains how this discovery shook her world. I had to close the book for a moment at this point.
Wait a minute, I thought. If resentment is in the envy family, why do we (physicians) often find ourselves resenting patients who take up our time? What are we envious of?
I took some time to think about how this might be true. Could it be that I’m envious they have the time I don’t have? I want to have all the time in the world to answer their questions, but the reality is I don’t.
Or maybe it’s because sometimes I feel the patient is expecting me to offer them something more than is available. A cure when there might be none.
But is this actually true? Or is this my unrealistic expectation of myself?
Here’s how Brené Brown defines resentment in her book: “Resentment is the feeling of frustration, judgment, anger, ‘better than,’ and/or hidden envy related to perceived unfairness or injustice. It’s an emotion that we often experience when we fail to set boundaries or ask for what we need, or when expectations let us down because they were based on things we can’t control, like what other people think, what they feel, or how they’re going to react.”
Wow, I thought, Healthcare checks all of these boxes.
- Perceived unfairness of work schedules? Check.
- Perceived injustice? Of course — we see that in our dealings with insurance company denials every day.
But those are both extrinsic. What about the intrinsic factors she’s calling us out on here?
- Do we, as physicians, fail to set boundaries?
- Do we fail to ask for what we need?
Hard yes and yes. (Do we even know, as physicians, what our own boundaries are?)
And the last one:
- Do our expectations of how our clinic day will go let us down every day because they’re based on things we can’t control?
My brain had to repeat the critical parts of that: Expectations let us down when they’re based on things we can’t control.
But wait, my brain argued back; I’m the physician, I thought I was supposed to get to control things.
Next, the revelation: Could it be that a key to experiencing less resentment is accepting how much control we don’t have in a typical day?
And a corollary: How much does resentment factor into burnout? (To read more on my personal journey with burnout, see this piece).
It so happens that around this same time, I was reading another excellent book, Changing How We Think About Difficult Patients: A Guide for Physicians and Healthcare Professionals, by Joan Naidorf, DO.
Dr Naidorf is an emergency medicine physician of 30 years who wrote the book to “provid[e] insight and tools to manage our negative thoughts about difficult patients” and help “beleaguered colleagues…return to their benevolent guiding principles and find more enjoyment in their vitally important careers.”
As I read Dr Naidorf’s book, I thus did so with the mindset of wanting to further understand for myself where this specific emotion of resentment toward our “difficult” patients could come from and how to best understand it in order to get past it.
Dr. Naidorf writes, “Challenging patients will never stop appearing… You cannot change them or control them—the only person you can control is you.”
I wondered how much the resentment we might involuntarily feel at being asked to see a “difficult” patient has nothing to do with the patient but everything to do with it making us feel not in control of the situation.
Dr. Naidorf also writes, “Negative thoughts about challenging patients can cause, in otherwise capable clinicians, a sense of inadequacy and incompetence.”
Do we perhaps resent our challenging patients because of the negative thoughts they sometimes trigger in us? If so, how does this relate to envy, as Dr. Brown asserts resentment is tied to? Is it triggering us to feel inadequate?
“[Difficult patients] often make us question ourselves,” Dr. Naidorf writes, “and we need to feel comfortable with the answers.”
Again, the discrepancy between expectations and reality creates the negative emotion.
Or, as Dr. Naidorf writes, “What if you could stop judging others so harshly and accept them exactly as they are?”
Hmmm, I thought, then the cessation of harsh judgment and implementation of acceptance would have to apply to us too. The elusive concept of self-compassion.
Maybe the resentment/envy comes from us not allowing ourselves to behave in this way because to do so would allow too much vulnerability. Something most of us were conditioned to avoid to survive medical training.
Dr. Brown also writes about an “aha” moment she had in her struggle to understand resentment. “I’m not mad because you’re resting. I’m mad because I’m so bone tired and I want to rest. But, unlike you, I’m going to pretend that I don’t need to.”
I felt all too seen in that passage. Could it be my old nemesis, perfectionism, creeping its way back in? Is resentment the ugly stepsister to perfectionism?
Perhaps challenging patients can engender resentment because they make us feel like we’re not living up to our own unrealistic expectations. And in that case, we need to change our unrealistic expectations for ourselves.
Dr Naidorf’s book explores much more on the complex matter of what makes a “difficult” patient, but I chose to focus here only on the resentment piece as a tie-in to Dr. Brown’s book. I highly recommend both books for further reading to help physicians and nurses navigate the complex emotions our jobs can trigger.
Most importantly, recognizing that we have these transient negative emotions does not make us bad people or healthcare professionals. It only makes us human.
Dr. Lycette is medical director, Providence Oncology and Hematology Care Clinic, Seaside, Ore. She has disclosed having no relevant financial relationships.
A version of this article first appeared on Medscape.com.
I have a secret. It’s one I think many physicians and nurses share. Sometimes, when I’m stretched too thin — overbooked, hungry, tired, fielding yet another appeal to an insurance company in the middle of a clinic day —
As soon as this happens, I feel immediate guilt. These are the worst moments of my day. Why the heck would I resent my patients? They’re the entire reason I’m there. I wouldn’t be a physician without patients to care for. I became a physician, and completed subspecialty training, to help patients. People.
Recently, I started thinking more about this emotion of resentment. What exactly is it, and where does it come from? Is what I’m feeling actually resentment? Or is it something else?
Two books I’ve recently read have helped me explore the complicated emotion of resentment and how it might play a role in burnout for both physicians and nurses.
First, Brené Brown’s most recent book, Atlas of the Heart: Mapping Meaningful Connection and the Language of Human Experience, provides a roadmap for 87 of our human emotions. (That’s right — 87!)
One emotion of the 87 that she shares has been a particular struggle for her has been our good old friend, resentment.
In her book, Dr Brown shares that she initially considered resentment to belong to the anger family of emotion. As I read this, I agreed. When I feel resentful, I associate that with feeling angry.
But she then writes about her discovery that resentment, in fact, belongs to the envy family. She explains how this discovery shook her world. I had to close the book for a moment at this point.
Wait a minute, I thought. If resentment is in the envy family, why do we (physicians) often find ourselves resenting patients who take up our time? What are we envious of?
I took some time to think about how this might be true. Could it be that I’m envious they have the time I don’t have? I want to have all the time in the world to answer their questions, but the reality is I don’t.
Or maybe it’s because sometimes I feel the patient is expecting me to offer them something more than is available. A cure when there might be none.
But is this actually true? Or is this my unrealistic expectation of myself?
Here’s how Brené Brown defines resentment in her book: “Resentment is the feeling of frustration, judgment, anger, ‘better than,’ and/or hidden envy related to perceived unfairness or injustice. It’s an emotion that we often experience when we fail to set boundaries or ask for what we need, or when expectations let us down because they were based on things we can’t control, like what other people think, what they feel, or how they’re going to react.”
Wow, I thought, Healthcare checks all of these boxes.
- Perceived unfairness of work schedules? Check.
- Perceived injustice? Of course — we see that in our dealings with insurance company denials every day.
But those are both extrinsic. What about the intrinsic factors she’s calling us out on here?
- Do we, as physicians, fail to set boundaries?
- Do we fail to ask for what we need?
Hard yes and yes. (Do we even know, as physicians, what our own boundaries are?)
And the last one:
- Do our expectations of how our clinic day will go let us down every day because they’re based on things we can’t control?
My brain had to repeat the critical parts of that: Expectations let us down when they’re based on things we can’t control.
But wait, my brain argued back; I’m the physician, I thought I was supposed to get to control things.
Next, the revelation: Could it be that a key to experiencing less resentment is accepting how much control we don’t have in a typical day?
And a corollary: How much does resentment factor into burnout? (To read more on my personal journey with burnout, see this piece).
It so happens that around this same time, I was reading another excellent book, Changing How We Think About Difficult Patients: A Guide for Physicians and Healthcare Professionals, by Joan Naidorf, DO.
Dr Naidorf is an emergency medicine physician of 30 years who wrote the book to “provid[e] insight and tools to manage our negative thoughts about difficult patients” and help “beleaguered colleagues…return to their benevolent guiding principles and find more enjoyment in their vitally important careers.”
As I read Dr Naidorf’s book, I thus did so with the mindset of wanting to further understand for myself where this specific emotion of resentment toward our “difficult” patients could come from and how to best understand it in order to get past it.
Dr. Naidorf writes, “Challenging patients will never stop appearing… You cannot change them or control them—the only person you can control is you.”
I wondered how much the resentment we might involuntarily feel at being asked to see a “difficult” patient has nothing to do with the patient but everything to do with it making us feel not in control of the situation.
Dr. Naidorf also writes, “Negative thoughts about challenging patients can cause, in otherwise capable clinicians, a sense of inadequacy and incompetence.”
Do we perhaps resent our challenging patients because of the negative thoughts they sometimes trigger in us? If so, how does this relate to envy, as Dr. Brown asserts resentment is tied to? Is it triggering us to feel inadequate?
“[Difficult patients] often make us question ourselves,” Dr. Naidorf writes, “and we need to feel comfortable with the answers.”
Again, the discrepancy between expectations and reality creates the negative emotion.
Or, as Dr. Naidorf writes, “What if you could stop judging others so harshly and accept them exactly as they are?”
Hmmm, I thought, then the cessation of harsh judgment and implementation of acceptance would have to apply to us too. The elusive concept of self-compassion.
Maybe the resentment/envy comes from us not allowing ourselves to behave in this way because to do so would allow too much vulnerability. Something most of us were conditioned to avoid to survive medical training.
Dr. Brown also writes about an “aha” moment she had in her struggle to understand resentment. “I’m not mad because you’re resting. I’m mad because I’m so bone tired and I want to rest. But, unlike you, I’m going to pretend that I don’t need to.”
I felt all too seen in that passage. Could it be my old nemesis, perfectionism, creeping its way back in? Is resentment the ugly stepsister to perfectionism?
Perhaps challenging patients can engender resentment because they make us feel like we’re not living up to our own unrealistic expectations. And in that case, we need to change our unrealistic expectations for ourselves.
Dr Naidorf’s book explores much more on the complex matter of what makes a “difficult” patient, but I chose to focus here only on the resentment piece as a tie-in to Dr. Brown’s book. I highly recommend both books for further reading to help physicians and nurses navigate the complex emotions our jobs can trigger.
Most importantly, recognizing that we have these transient negative emotions does not make us bad people or healthcare professionals. It only makes us human.
Dr. Lycette is medical director, Providence Oncology and Hematology Care Clinic, Seaside, Ore. She has disclosed having no relevant financial relationships.
A version of this article first appeared on Medscape.com.
When physicians are the plaintiffs
Have you experienced malpractice?
No, I’m not asking whether you have experienced litigation. I’m asking whether you, as a physician, have actually experienced substandard care from a colleague. I have heard many such experiences over the years, and mistreatment doesn’t seem to be getting any less frequent.
The first is that, unlike the Pope, who has a dedicated confessor trained to minister to his spiritual needs, no one formally trains physicians to treat physicians. As a result, most of us feel slightly uneasy at treating other physicians. We naturally wish to keep our colleagues well, but at the same time realize that our clinical skills are being very closely scrutinized. What if they are found to be wanting? This discomfiture can make a physician treating a physician overly compulsive, or worse, overtly dismissive.
Second, we physicians are famously poor patients. We pretend we don’t need the advice we give others, to monitor our health and promptly seek care when something feels amiss. And, for the period during which we delay a medical encounter, we often attempt to diagnose and treat ourselves.
Sometimes we are successful, which reinforces this approach. Other times, we fail at being our own caregiver and present to someone else either too late, or with avoidable complications. In the former instance, we congratulate ourselves and learn nothing from the experience. In the latter, we may heap shame upon ourselves for our folly, and we may learn; but it could be a lethal lesson. In the worst scenario, our colleague gives in to frustration (or angst), and heaps even more shame onto their late-presenting physician patient.
Third, when we do submit to being a patient, we often demand VIP treatment. This is probably in response to our anxiety that some of the worst things we have seen happen to patients might happen to us if we are not vigilant to ensure we receive a higher level of care. But of course, such hypervigilance can lead to excessive care and testing, with all the attendant hazards, or alternatively to dilution of care if our caregivers decide we are just too much trouble.
Fourth, as a fifth-generation physician myself, I am convinced that physicians and physician family members are either prone to unusual manifestations of common diseases or unusual diseases, or that rare disease entities and complications are actually more common than literature suggests, and they simply aren’t pursued or diagnosed in nonphysician families.
No matter how we may have arrived in a position to need medical care, how often is such care substandard? And how do we respond when we suspect, or know, this to be the case? Are physicians more, or less, likely to take legal action in the face of it?
I certainly don’t know any statistics. Physicians are in an excellent position to take such action, because judges and juries will likely believe that a doctor can recognize negligence when we fall victim to it. But we may also be reluctant to publicly admit the way (or ways) in which we may have contributed to substandard care or outcome.
Based on decades of working with physician clients who have been sued, and having been sued myself (thus witnessing and also experiencing the effects of litigation), I am probably more reluctant than normal patients or physicians to consider taking legal action. This, despite the fact that I am also a lawyer and (through organized medicine) know many colleagues in all specialties who might serve as expert witnesses.
I have experienced serial substandard care, which has left me highly conflicted about the efficacy of my chosen profession. As a resident, I had my first odd pain condition and consulted an “elder statesperson” from my institution, whom I assumed to be a “doctor’s doctor” because he was a superb teacher (wrong!)
He completely missed the diagnosis and further belittled (indeed, libeled) me in the medical record. (Some years later, I learned that, during that period, he was increasingly demented and tended to view all female patients as having “wandering uterus” equivalents.) Fortunately, I found a better diagnostician, or at least one more willing to lend credence to my complaints, who successfully removed the first of several “zebra” lesions I have experienced.
As a young faculty member, I had an odd presentation of a recurring gynecologic condition, which was treated surgically, successfully, except that my fertility was cut in half – a possibility about which I had not been informed when giving operative consent. Would I have sued this fellow faculty member for that? Never, because she invariably treated me with respect as a colleague.
Later in my career after leaving academia, the same condition recurred in a new location. My old-school gynecologist desired to do an extensive procedure, to which I demurred unless specific pathology was found intraoperatively. Affronted, he subjected me to laparoscopy, did nothing but look, and then left the hospital leaving me and the PACU nurse to try to decipher his instructions (which said, basically, “I didn’t find anything; don’t bother me again.”). Several years of pain later, a younger gynecologist performed the correct procedure to address my problem, which has never recurred. Would I have sued him? No, because I believe he had a disability.
At age 59, I developed a new mole. My beloved general practitioner, in the waning years of his practice, forgot to consult a colleague to remove it for several months. When I forced the issue, the mole was removed and turned out to be a rare pediatric condition considered a precursor to melanoma. The same general practitioner had told me I needn’t worry about my “mild hypercalcemia.”
Ten years later I diagnosed my own parathyroid adenoma, in the interim losing 10% of my bone density. Would I have sued him? No, for he always showed he cared. (Though maybe, if I had fractured my spine or hip.)
If you have been the victim of physician malpractice, how did you respond?
Do we serve our profession well by how we handle substandard care – upon ourselves (or our loved ones)?
Dr. Andrew is a former assistant professor in the department of emergency medicine, Johns Hopkins University, Baltimore, and founder and principal of MDMentor, Victoria, B.C.
A version of this article first appeared on Medscape.com.
Have you experienced malpractice?
No, I’m not asking whether you have experienced litigation. I’m asking whether you, as a physician, have actually experienced substandard care from a colleague. I have heard many such experiences over the years, and mistreatment doesn’t seem to be getting any less frequent.
The first is that, unlike the Pope, who has a dedicated confessor trained to minister to his spiritual needs, no one formally trains physicians to treat physicians. As a result, most of us feel slightly uneasy at treating other physicians. We naturally wish to keep our colleagues well, but at the same time realize that our clinical skills are being very closely scrutinized. What if they are found to be wanting? This discomfiture can make a physician treating a physician overly compulsive, or worse, overtly dismissive.
Second, we physicians are famously poor patients. We pretend we don’t need the advice we give others, to monitor our health and promptly seek care when something feels amiss. And, for the period during which we delay a medical encounter, we often attempt to diagnose and treat ourselves.
Sometimes we are successful, which reinforces this approach. Other times, we fail at being our own caregiver and present to someone else either too late, or with avoidable complications. In the former instance, we congratulate ourselves and learn nothing from the experience. In the latter, we may heap shame upon ourselves for our folly, and we may learn; but it could be a lethal lesson. In the worst scenario, our colleague gives in to frustration (or angst), and heaps even more shame onto their late-presenting physician patient.
Third, when we do submit to being a patient, we often demand VIP treatment. This is probably in response to our anxiety that some of the worst things we have seen happen to patients might happen to us if we are not vigilant to ensure we receive a higher level of care. But of course, such hypervigilance can lead to excessive care and testing, with all the attendant hazards, or alternatively to dilution of care if our caregivers decide we are just too much trouble.
Fourth, as a fifth-generation physician myself, I am convinced that physicians and physician family members are either prone to unusual manifestations of common diseases or unusual diseases, or that rare disease entities and complications are actually more common than literature suggests, and they simply aren’t pursued or diagnosed in nonphysician families.
No matter how we may have arrived in a position to need medical care, how often is such care substandard? And how do we respond when we suspect, or know, this to be the case? Are physicians more, or less, likely to take legal action in the face of it?
I certainly don’t know any statistics. Physicians are in an excellent position to take such action, because judges and juries will likely believe that a doctor can recognize negligence when we fall victim to it. But we may also be reluctant to publicly admit the way (or ways) in which we may have contributed to substandard care or outcome.
Based on decades of working with physician clients who have been sued, and having been sued myself (thus witnessing and also experiencing the effects of litigation), I am probably more reluctant than normal patients or physicians to consider taking legal action. This, despite the fact that I am also a lawyer and (through organized medicine) know many colleagues in all specialties who might serve as expert witnesses.
I have experienced serial substandard care, which has left me highly conflicted about the efficacy of my chosen profession. As a resident, I had my first odd pain condition and consulted an “elder statesperson” from my institution, whom I assumed to be a “doctor’s doctor” because he was a superb teacher (wrong!)
He completely missed the diagnosis and further belittled (indeed, libeled) me in the medical record. (Some years later, I learned that, during that period, he was increasingly demented and tended to view all female patients as having “wandering uterus” equivalents.) Fortunately, I found a better diagnostician, or at least one more willing to lend credence to my complaints, who successfully removed the first of several “zebra” lesions I have experienced.
As a young faculty member, I had an odd presentation of a recurring gynecologic condition, which was treated surgically, successfully, except that my fertility was cut in half – a possibility about which I had not been informed when giving operative consent. Would I have sued this fellow faculty member for that? Never, because she invariably treated me with respect as a colleague.
Later in my career after leaving academia, the same condition recurred in a new location. My old-school gynecologist desired to do an extensive procedure, to which I demurred unless specific pathology was found intraoperatively. Affronted, he subjected me to laparoscopy, did nothing but look, and then left the hospital leaving me and the PACU nurse to try to decipher his instructions (which said, basically, “I didn’t find anything; don’t bother me again.”). Several years of pain later, a younger gynecologist performed the correct procedure to address my problem, which has never recurred. Would I have sued him? No, because I believe he had a disability.
At age 59, I developed a new mole. My beloved general practitioner, in the waning years of his practice, forgot to consult a colleague to remove it for several months. When I forced the issue, the mole was removed and turned out to be a rare pediatric condition considered a precursor to melanoma. The same general practitioner had told me I needn’t worry about my “mild hypercalcemia.”
Ten years later I diagnosed my own parathyroid adenoma, in the interim losing 10% of my bone density. Would I have sued him? No, for he always showed he cared. (Though maybe, if I had fractured my spine or hip.)
If you have been the victim of physician malpractice, how did you respond?
Do we serve our profession well by how we handle substandard care – upon ourselves (or our loved ones)?
Dr. Andrew is a former assistant professor in the department of emergency medicine, Johns Hopkins University, Baltimore, and founder and principal of MDMentor, Victoria, B.C.
A version of this article first appeared on Medscape.com.
Have you experienced malpractice?
No, I’m not asking whether you have experienced litigation. I’m asking whether you, as a physician, have actually experienced substandard care from a colleague. I have heard many such experiences over the years, and mistreatment doesn’t seem to be getting any less frequent.
The first is that, unlike the Pope, who has a dedicated confessor trained to minister to his spiritual needs, no one formally trains physicians to treat physicians. As a result, most of us feel slightly uneasy at treating other physicians. We naturally wish to keep our colleagues well, but at the same time realize that our clinical skills are being very closely scrutinized. What if they are found to be wanting? This discomfiture can make a physician treating a physician overly compulsive, or worse, overtly dismissive.
Second, we physicians are famously poor patients. We pretend we don’t need the advice we give others, to monitor our health and promptly seek care when something feels amiss. And, for the period during which we delay a medical encounter, we often attempt to diagnose and treat ourselves.
Sometimes we are successful, which reinforces this approach. Other times, we fail at being our own caregiver and present to someone else either too late, or with avoidable complications. In the former instance, we congratulate ourselves and learn nothing from the experience. In the latter, we may heap shame upon ourselves for our folly, and we may learn; but it could be a lethal lesson. In the worst scenario, our colleague gives in to frustration (or angst), and heaps even more shame onto their late-presenting physician patient.
Third, when we do submit to being a patient, we often demand VIP treatment. This is probably in response to our anxiety that some of the worst things we have seen happen to patients might happen to us if we are not vigilant to ensure we receive a higher level of care. But of course, such hypervigilance can lead to excessive care and testing, with all the attendant hazards, or alternatively to dilution of care if our caregivers decide we are just too much trouble.
Fourth, as a fifth-generation physician myself, I am convinced that physicians and physician family members are either prone to unusual manifestations of common diseases or unusual diseases, or that rare disease entities and complications are actually more common than literature suggests, and they simply aren’t pursued or diagnosed in nonphysician families.
No matter how we may have arrived in a position to need medical care, how often is such care substandard? And how do we respond when we suspect, or know, this to be the case? Are physicians more, or less, likely to take legal action in the face of it?
I certainly don’t know any statistics. Physicians are in an excellent position to take such action, because judges and juries will likely believe that a doctor can recognize negligence when we fall victim to it. But we may also be reluctant to publicly admit the way (or ways) in which we may have contributed to substandard care or outcome.
Based on decades of working with physician clients who have been sued, and having been sued myself (thus witnessing and also experiencing the effects of litigation), I am probably more reluctant than normal patients or physicians to consider taking legal action. This, despite the fact that I am also a lawyer and (through organized medicine) know many colleagues in all specialties who might serve as expert witnesses.
I have experienced serial substandard care, which has left me highly conflicted about the efficacy of my chosen profession. As a resident, I had my first odd pain condition and consulted an “elder statesperson” from my institution, whom I assumed to be a “doctor’s doctor” because he was a superb teacher (wrong!)
He completely missed the diagnosis and further belittled (indeed, libeled) me in the medical record. (Some years later, I learned that, during that period, he was increasingly demented and tended to view all female patients as having “wandering uterus” equivalents.) Fortunately, I found a better diagnostician, or at least one more willing to lend credence to my complaints, who successfully removed the first of several “zebra” lesions I have experienced.
As a young faculty member, I had an odd presentation of a recurring gynecologic condition, which was treated surgically, successfully, except that my fertility was cut in half – a possibility about which I had not been informed when giving operative consent. Would I have sued this fellow faculty member for that? Never, because she invariably treated me with respect as a colleague.
Later in my career after leaving academia, the same condition recurred in a new location. My old-school gynecologist desired to do an extensive procedure, to which I demurred unless specific pathology was found intraoperatively. Affronted, he subjected me to laparoscopy, did nothing but look, and then left the hospital leaving me and the PACU nurse to try to decipher his instructions (which said, basically, “I didn’t find anything; don’t bother me again.”). Several years of pain later, a younger gynecologist performed the correct procedure to address my problem, which has never recurred. Would I have sued him? No, because I believe he had a disability.
At age 59, I developed a new mole. My beloved general practitioner, in the waning years of his practice, forgot to consult a colleague to remove it for several months. When I forced the issue, the mole was removed and turned out to be a rare pediatric condition considered a precursor to melanoma. The same general practitioner had told me I needn’t worry about my “mild hypercalcemia.”
Ten years later I diagnosed my own parathyroid adenoma, in the interim losing 10% of my bone density. Would I have sued him? No, for he always showed he cared. (Though maybe, if I had fractured my spine or hip.)
If you have been the victim of physician malpractice, how did you respond?
Do we serve our profession well by how we handle substandard care – upon ourselves (or our loved ones)?
Dr. Andrew is a former assistant professor in the department of emergency medicine, Johns Hopkins University, Baltimore, and founder and principal of MDMentor, Victoria, B.C.
A version of this article first appeared on Medscape.com.