Believing in conspiracy theories is not delusional

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When many people across the country, not to mention in public officebelieve that the world is run by a group of Satanic pedophiles that includes top Democrats and Hollywood elites, and that former President Trump is leading a secret mission to bring these evildoers to justice, one can’t help but ask if they’re at least to some degree mentally impaired.

Dr. Ronald W. Pies

Conspiracy theories are often received with psychiatric connotations; associated with paranoid plan-hatchers, and nonbelieving outsiders. But whereas theories such as QAnon strain credibility for many people, we would argue that they are likely not the product of psychosis or mental illness; nor do conspiracy theories in general represent delusions.



For one thing, surveys have consistently revealed that about 50% of the population believes in at least one conspiracy theory. Furthermore, there are several substantive differences between conspiracy theory beliefs and delusions.

Some researchers consider conspiracy theories to be “a subset of false beliefs,” but  most scholars, ourselves included, do not prejudge their validity or veracity. Real-life conspiracies, such as the CIA’s MK-Ultra program, have clearly occurred throughout history.

Our central contention is that belief in conspiracy theories is distinct from psychosis, and more closely resembles extreme but subculturally sanctioned religious or political beliefs. However, the line between believing in conspiracies and being delusional becomes blurred when the believer becomes part of the conspiracy theory and feels compelled to act on the belief as part of a personal mission.

Take Edgar Maddison Welch, a 28-year-old man who firmly believed the so-called “Pizzagate” conspiracy theory – the baseless claim that Hillary Clinton and Democratic elites were running a child sex-trafficking ring out of a Washington, DC, pizzeria. Seeing himself a potential savior of children, Mr. Welch drove 350 miles to the pizza shop from his home in North Carolina in December 2016 and fired three shots from an AR-15 style rifle into a locked closet door, ultimately surrendering to police. However, on questioning he quickly conceded, “The intel on this wasn’t 100%.”

Who believes in conspiracy theories?

Given that half the population believes in at least one conspiracy theory, it should come as little surprise that there is no reliable “profile” for believers. Although some studies have suggested associations with low educationright-wing political orientation, and certain personality traits like subclinical paranoia and schizotypy, such findings have been inconsistent and may vary across specific conspiracy theory. Associations between conspiracy belief and paranoia suggest overlap within a “conspiratorial mindset,” with recent evidence that “distrust of officialdom” is a key mediator between believing in conspiracies and political ideology.

Dr. Joseph M. Pierre

Other quantitative “cognitive quirks” reported in those who believe in conspiracies are a need for certainty and control, a need for uniqueness, illusory pattern perception, and lack of analytical thinking. It’s unclear which of these factors may represent universal cognitive explanations for conspiratorial beliefs, vs. those that might be related to specific beliefs, such as the need for certainty during times of crisis and societal upheaval, when conspiracy theories tend to flourish.

Much of the research on conspiracy theory belief is based on the questionable premise that it’s best understood at the level of the individual’s psychopathology, or the “deficit model,” as it’s called. One of us (JMP) has instead proposed a two-component model that includes social and informational contexts. The first component – epistemic mistrust – involves mistrusting conventional, “authoritative” knowledge. The second involves biased information processing and exposure to misinformation, often transmitted by word of mouth, or through social networks. With this model, believing in conspiracy theories could be conceived as involving “delusion-like beliefs,” but not frank psychosis or full-blown delusions, as one might see, for example, in schizophrenia.

Indeed, many of the cognitive characteristics associated with conspiracy theory belief are universal, continuously distributed traits, varying in quantity, rather than all-or-none variables or distinct symptoms of mental illness.

Essentially, delusions are fixed, false, usually unshared beliefs, often based on subjective “inner” experience. (One rare exception is the so-called folie à deux, in which two people appear to “share” the same delusion; however, psychiatrists have long debated whether both individuals should be considered truly delusional). The delusion’s content is often “self-referential”; i.e., focused primarily on the believer.

In contrast, conspiracy theories are usually, but not necessarily, false. They are typically shared beliefs that don’t explicitly or directly involve the believer, and are based on evidence that one finds “out there,” such as on the Internet. This speaks to the highly communal nature of so many conspiracy theories – networks of like-minded individuals reinforcing one another’s beliefs in a particular socio-cultural context.
 

 

 

Conspiracy theory belief, COVID-19, and medical intervention

As for medical conspiracy theories, none have flourished recently more so than those involving the COVID-19 pandemic. As a recent editorial by Stein and colleagues noted, “Some conspiratorial claims include assertions that COVID‐19 is a hoax; arguments that the virus was created artificially and spread on purpose as a bioweapon; or allegations that governments are using the emergency situation to pursue their antidemocratic goals. … Other conspiracies argued that people in power are taking advantage of the pandemic as a plan to inject microchip quantum-dot spy software and monitor people.”

Stein and colleagues make the important point that a “key difference between COVID‐19 and the 1918 flu pandemic ... is that [now] a highly interconnected world, to a great extent on social media, is setting the stage for distributing information and misinformation about COVID‐19.”

Consider the following composite vignette: Mr. A is a 70-year-old retiree with a history of COPD who has been advised by his PCP to get vaccinated against COVID-19. He is extremely reluctant to do so, fearing that “the vaccine is going to change my DNA” and “might even give me COVID.” He has heard from friends on social media that vaccine developers “faked the results” and are “in cahoots with the federal government.” Mr. A has heard “experts” declare the vaccines safe, but does not trust them. Mr. A has no psychiatric or substance abuse history, and there are no cognitive, perceptual, or other abnormalities in Mr. A’s mental status exam.

Mr. A’s beliefs qualify as a “conspiracy theory,” but probably represent widely held misconceptions about COVID-19 vaccines, as well as widespread mistrust of pharmaceutical companies and the federal government. Based on the information provided, there is no basis for concluding that Mr. A is psychotic or delusional. His beliefs appear to be the result of “epistemic mistrust” of authoritative informational accounts, biased information processing, and exposure to misinformation.

How should the physician manage and care for patients like Mr. A? Absent frank delusions, there is no role for antipsychotic medication, though for extremely anxious patients, a time-limited course of an antianxiety agent may sometimes be warranted. In addition to providing accurate medical information to the patient, the physician should avoid arguing, or trying to “talk the patient out of” his or her belief. Instead, the focus should be on sustaining and strengthening the physician-patient alliance, establishing an atmosphere of respect and safety, clarifying differences in trusted sources of medical information, and allowing the patient time to process the physician’s recommendations.

One-to-one engagement with health care providers has proved effective in reducing vaccine hesitancy and correcting misinformation. For patients with less fixed conspiracy theory beliefs, it may sometimes be helpful to gently offer alternative hypotheses to the patient’s conspiracy theory, using elements of cognitive-behavioral therapy (CBT). For example, a physician might ask, “Is it possible that the online source you read was mistaken about the vaccine changing your DNA?” while reminding patients that – contrary to popular belief – mRNA vaccines have been in development against cancer for several decades.

Challenging beliefs collaboratively and acknowledging areas of uncertainty, rather than confronting or arguing about false beliefs, can foster trust between physician and patient and, at the very least, open a dialogue regarding potential exposure to medical misinformation. “Inoculation” strategies that present and then dispel misinformation before patients become aware of it are among the best supported strategies for mitigating conspiracy theory belief. Ideally, physicians and health care systems should maintain an ongoing “inventory” of medical misinformation circulating online and “beat it to the punch” with reliable information.

Finally, because believing in conspiracy theories is often associated with a sense of uncertainty, and feeling that one’s life is “out of control,” medical interventions can be framed as ways of regaining control and appealing to patients’ values; for example, saying, “By getting the vaccine, you’ll be more likely to stay in good health, protect your family, and do all the things you want to do.”
 

Dr. Pies is professor of psychiatry and a lecturer on bioethics and humanities at State University of New York, Syracuse. Dr. Pierre is a health sciences clinical professor in the department of psychiatry and biobehavioral sciences at the University of California, Los Angeles. A version of this article first appeared on Medscape.com.

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When many people across the country, not to mention in public officebelieve that the world is run by a group of Satanic pedophiles that includes top Democrats and Hollywood elites, and that former President Trump is leading a secret mission to bring these evildoers to justice, one can’t help but ask if they’re at least to some degree mentally impaired.

Dr. Ronald W. Pies

Conspiracy theories are often received with psychiatric connotations; associated with paranoid plan-hatchers, and nonbelieving outsiders. But whereas theories such as QAnon strain credibility for many people, we would argue that they are likely not the product of psychosis or mental illness; nor do conspiracy theories in general represent delusions.



For one thing, surveys have consistently revealed that about 50% of the population believes in at least one conspiracy theory. Furthermore, there are several substantive differences between conspiracy theory beliefs and delusions.

Some researchers consider conspiracy theories to be “a subset of false beliefs,” but  most scholars, ourselves included, do not prejudge their validity or veracity. Real-life conspiracies, such as the CIA’s MK-Ultra program, have clearly occurred throughout history.

Our central contention is that belief in conspiracy theories is distinct from psychosis, and more closely resembles extreme but subculturally sanctioned religious or political beliefs. However, the line between believing in conspiracies and being delusional becomes blurred when the believer becomes part of the conspiracy theory and feels compelled to act on the belief as part of a personal mission.

Take Edgar Maddison Welch, a 28-year-old man who firmly believed the so-called “Pizzagate” conspiracy theory – the baseless claim that Hillary Clinton and Democratic elites were running a child sex-trafficking ring out of a Washington, DC, pizzeria. Seeing himself a potential savior of children, Mr. Welch drove 350 miles to the pizza shop from his home in North Carolina in December 2016 and fired three shots from an AR-15 style rifle into a locked closet door, ultimately surrendering to police. However, on questioning he quickly conceded, “The intel on this wasn’t 100%.”

Who believes in conspiracy theories?

Given that half the population believes in at least one conspiracy theory, it should come as little surprise that there is no reliable “profile” for believers. Although some studies have suggested associations with low educationright-wing political orientation, and certain personality traits like subclinical paranoia and schizotypy, such findings have been inconsistent and may vary across specific conspiracy theory. Associations between conspiracy belief and paranoia suggest overlap within a “conspiratorial mindset,” with recent evidence that “distrust of officialdom” is a key mediator between believing in conspiracies and political ideology.

Dr. Joseph M. Pierre

Other quantitative “cognitive quirks” reported in those who believe in conspiracies are a need for certainty and control, a need for uniqueness, illusory pattern perception, and lack of analytical thinking. It’s unclear which of these factors may represent universal cognitive explanations for conspiratorial beliefs, vs. those that might be related to specific beliefs, such as the need for certainty during times of crisis and societal upheaval, when conspiracy theories tend to flourish.

Much of the research on conspiracy theory belief is based on the questionable premise that it’s best understood at the level of the individual’s psychopathology, or the “deficit model,” as it’s called. One of us (JMP) has instead proposed a two-component model that includes social and informational contexts. The first component – epistemic mistrust – involves mistrusting conventional, “authoritative” knowledge. The second involves biased information processing and exposure to misinformation, often transmitted by word of mouth, or through social networks. With this model, believing in conspiracy theories could be conceived as involving “delusion-like beliefs,” but not frank psychosis or full-blown delusions, as one might see, for example, in schizophrenia.

Indeed, many of the cognitive characteristics associated with conspiracy theory belief are universal, continuously distributed traits, varying in quantity, rather than all-or-none variables or distinct symptoms of mental illness.

Essentially, delusions are fixed, false, usually unshared beliefs, often based on subjective “inner” experience. (One rare exception is the so-called folie à deux, in which two people appear to “share” the same delusion; however, psychiatrists have long debated whether both individuals should be considered truly delusional). The delusion’s content is often “self-referential”; i.e., focused primarily on the believer.

In contrast, conspiracy theories are usually, but not necessarily, false. They are typically shared beliefs that don’t explicitly or directly involve the believer, and are based on evidence that one finds “out there,” such as on the Internet. This speaks to the highly communal nature of so many conspiracy theories – networks of like-minded individuals reinforcing one another’s beliefs in a particular socio-cultural context.
 

 

 

Conspiracy theory belief, COVID-19, and medical intervention

As for medical conspiracy theories, none have flourished recently more so than those involving the COVID-19 pandemic. As a recent editorial by Stein and colleagues noted, “Some conspiratorial claims include assertions that COVID‐19 is a hoax; arguments that the virus was created artificially and spread on purpose as a bioweapon; or allegations that governments are using the emergency situation to pursue their antidemocratic goals. … Other conspiracies argued that people in power are taking advantage of the pandemic as a plan to inject microchip quantum-dot spy software and monitor people.”

Stein and colleagues make the important point that a “key difference between COVID‐19 and the 1918 flu pandemic ... is that [now] a highly interconnected world, to a great extent on social media, is setting the stage for distributing information and misinformation about COVID‐19.”

Consider the following composite vignette: Mr. A is a 70-year-old retiree with a history of COPD who has been advised by his PCP to get vaccinated against COVID-19. He is extremely reluctant to do so, fearing that “the vaccine is going to change my DNA” and “might even give me COVID.” He has heard from friends on social media that vaccine developers “faked the results” and are “in cahoots with the federal government.” Mr. A has heard “experts” declare the vaccines safe, but does not trust them. Mr. A has no psychiatric or substance abuse history, and there are no cognitive, perceptual, or other abnormalities in Mr. A’s mental status exam.

Mr. A’s beliefs qualify as a “conspiracy theory,” but probably represent widely held misconceptions about COVID-19 vaccines, as well as widespread mistrust of pharmaceutical companies and the federal government. Based on the information provided, there is no basis for concluding that Mr. A is psychotic or delusional. His beliefs appear to be the result of “epistemic mistrust” of authoritative informational accounts, biased information processing, and exposure to misinformation.

How should the physician manage and care for patients like Mr. A? Absent frank delusions, there is no role for antipsychotic medication, though for extremely anxious patients, a time-limited course of an antianxiety agent may sometimes be warranted. In addition to providing accurate medical information to the patient, the physician should avoid arguing, or trying to “talk the patient out of” his or her belief. Instead, the focus should be on sustaining and strengthening the physician-patient alliance, establishing an atmosphere of respect and safety, clarifying differences in trusted sources of medical information, and allowing the patient time to process the physician’s recommendations.

One-to-one engagement with health care providers has proved effective in reducing vaccine hesitancy and correcting misinformation. For patients with less fixed conspiracy theory beliefs, it may sometimes be helpful to gently offer alternative hypotheses to the patient’s conspiracy theory, using elements of cognitive-behavioral therapy (CBT). For example, a physician might ask, “Is it possible that the online source you read was mistaken about the vaccine changing your DNA?” while reminding patients that – contrary to popular belief – mRNA vaccines have been in development against cancer for several decades.

Challenging beliefs collaboratively and acknowledging areas of uncertainty, rather than confronting or arguing about false beliefs, can foster trust between physician and patient and, at the very least, open a dialogue regarding potential exposure to medical misinformation. “Inoculation” strategies that present and then dispel misinformation before patients become aware of it are among the best supported strategies for mitigating conspiracy theory belief. Ideally, physicians and health care systems should maintain an ongoing “inventory” of medical misinformation circulating online and “beat it to the punch” with reliable information.

Finally, because believing in conspiracy theories is often associated with a sense of uncertainty, and feeling that one’s life is “out of control,” medical interventions can be framed as ways of regaining control and appealing to patients’ values; for example, saying, “By getting the vaccine, you’ll be more likely to stay in good health, protect your family, and do all the things you want to do.”
 

Dr. Pies is professor of psychiatry and a lecturer on bioethics and humanities at State University of New York, Syracuse. Dr. Pierre is a health sciences clinical professor in the department of psychiatry and biobehavioral sciences at the University of California, Los Angeles. A version of this article first appeared on Medscape.com.

When many people across the country, not to mention in public officebelieve that the world is run by a group of Satanic pedophiles that includes top Democrats and Hollywood elites, and that former President Trump is leading a secret mission to bring these evildoers to justice, one can’t help but ask if they’re at least to some degree mentally impaired.

Dr. Ronald W. Pies

Conspiracy theories are often received with psychiatric connotations; associated with paranoid plan-hatchers, and nonbelieving outsiders. But whereas theories such as QAnon strain credibility for many people, we would argue that they are likely not the product of psychosis or mental illness; nor do conspiracy theories in general represent delusions.



For one thing, surveys have consistently revealed that about 50% of the population believes in at least one conspiracy theory. Furthermore, there are several substantive differences between conspiracy theory beliefs and delusions.

Some researchers consider conspiracy theories to be “a subset of false beliefs,” but  most scholars, ourselves included, do not prejudge their validity or veracity. Real-life conspiracies, such as the CIA’s MK-Ultra program, have clearly occurred throughout history.

Our central contention is that belief in conspiracy theories is distinct from psychosis, and more closely resembles extreme but subculturally sanctioned religious or political beliefs. However, the line between believing in conspiracies and being delusional becomes blurred when the believer becomes part of the conspiracy theory and feels compelled to act on the belief as part of a personal mission.

Take Edgar Maddison Welch, a 28-year-old man who firmly believed the so-called “Pizzagate” conspiracy theory – the baseless claim that Hillary Clinton and Democratic elites were running a child sex-trafficking ring out of a Washington, DC, pizzeria. Seeing himself a potential savior of children, Mr. Welch drove 350 miles to the pizza shop from his home in North Carolina in December 2016 and fired three shots from an AR-15 style rifle into a locked closet door, ultimately surrendering to police. However, on questioning he quickly conceded, “The intel on this wasn’t 100%.”

Who believes in conspiracy theories?

Given that half the population believes in at least one conspiracy theory, it should come as little surprise that there is no reliable “profile” for believers. Although some studies have suggested associations with low educationright-wing political orientation, and certain personality traits like subclinical paranoia and schizotypy, such findings have been inconsistent and may vary across specific conspiracy theory. Associations between conspiracy belief and paranoia suggest overlap within a “conspiratorial mindset,” with recent evidence that “distrust of officialdom” is a key mediator between believing in conspiracies and political ideology.

Dr. Joseph M. Pierre

Other quantitative “cognitive quirks” reported in those who believe in conspiracies are a need for certainty and control, a need for uniqueness, illusory pattern perception, and lack of analytical thinking. It’s unclear which of these factors may represent universal cognitive explanations for conspiratorial beliefs, vs. those that might be related to specific beliefs, such as the need for certainty during times of crisis and societal upheaval, when conspiracy theories tend to flourish.

Much of the research on conspiracy theory belief is based on the questionable premise that it’s best understood at the level of the individual’s psychopathology, or the “deficit model,” as it’s called. One of us (JMP) has instead proposed a two-component model that includes social and informational contexts. The first component – epistemic mistrust – involves mistrusting conventional, “authoritative” knowledge. The second involves biased information processing and exposure to misinformation, often transmitted by word of mouth, or through social networks. With this model, believing in conspiracy theories could be conceived as involving “delusion-like beliefs,” but not frank psychosis or full-blown delusions, as one might see, for example, in schizophrenia.

Indeed, many of the cognitive characteristics associated with conspiracy theory belief are universal, continuously distributed traits, varying in quantity, rather than all-or-none variables or distinct symptoms of mental illness.

Essentially, delusions are fixed, false, usually unshared beliefs, often based on subjective “inner” experience. (One rare exception is the so-called folie à deux, in which two people appear to “share” the same delusion; however, psychiatrists have long debated whether both individuals should be considered truly delusional). The delusion’s content is often “self-referential”; i.e., focused primarily on the believer.

In contrast, conspiracy theories are usually, but not necessarily, false. They are typically shared beliefs that don’t explicitly or directly involve the believer, and are based on evidence that one finds “out there,” such as on the Internet. This speaks to the highly communal nature of so many conspiracy theories – networks of like-minded individuals reinforcing one another’s beliefs in a particular socio-cultural context.
 

 

 

Conspiracy theory belief, COVID-19, and medical intervention

As for medical conspiracy theories, none have flourished recently more so than those involving the COVID-19 pandemic. As a recent editorial by Stein and colleagues noted, “Some conspiratorial claims include assertions that COVID‐19 is a hoax; arguments that the virus was created artificially and spread on purpose as a bioweapon; or allegations that governments are using the emergency situation to pursue their antidemocratic goals. … Other conspiracies argued that people in power are taking advantage of the pandemic as a plan to inject microchip quantum-dot spy software and monitor people.”

Stein and colleagues make the important point that a “key difference between COVID‐19 and the 1918 flu pandemic ... is that [now] a highly interconnected world, to a great extent on social media, is setting the stage for distributing information and misinformation about COVID‐19.”

Consider the following composite vignette: Mr. A is a 70-year-old retiree with a history of COPD who has been advised by his PCP to get vaccinated against COVID-19. He is extremely reluctant to do so, fearing that “the vaccine is going to change my DNA” and “might even give me COVID.” He has heard from friends on social media that vaccine developers “faked the results” and are “in cahoots with the federal government.” Mr. A has heard “experts” declare the vaccines safe, but does not trust them. Mr. A has no psychiatric or substance abuse history, and there are no cognitive, perceptual, or other abnormalities in Mr. A’s mental status exam.

Mr. A’s beliefs qualify as a “conspiracy theory,” but probably represent widely held misconceptions about COVID-19 vaccines, as well as widespread mistrust of pharmaceutical companies and the federal government. Based on the information provided, there is no basis for concluding that Mr. A is psychotic or delusional. His beliefs appear to be the result of “epistemic mistrust” of authoritative informational accounts, biased information processing, and exposure to misinformation.

How should the physician manage and care for patients like Mr. A? Absent frank delusions, there is no role for antipsychotic medication, though for extremely anxious patients, a time-limited course of an antianxiety agent may sometimes be warranted. In addition to providing accurate medical information to the patient, the physician should avoid arguing, or trying to “talk the patient out of” his or her belief. Instead, the focus should be on sustaining and strengthening the physician-patient alliance, establishing an atmosphere of respect and safety, clarifying differences in trusted sources of medical information, and allowing the patient time to process the physician’s recommendations.

One-to-one engagement with health care providers has proved effective in reducing vaccine hesitancy and correcting misinformation. For patients with less fixed conspiracy theory beliefs, it may sometimes be helpful to gently offer alternative hypotheses to the patient’s conspiracy theory, using elements of cognitive-behavioral therapy (CBT). For example, a physician might ask, “Is it possible that the online source you read was mistaken about the vaccine changing your DNA?” while reminding patients that – contrary to popular belief – mRNA vaccines have been in development against cancer for several decades.

Challenging beliefs collaboratively and acknowledging areas of uncertainty, rather than confronting or arguing about false beliefs, can foster trust between physician and patient and, at the very least, open a dialogue regarding potential exposure to medical misinformation. “Inoculation” strategies that present and then dispel misinformation before patients become aware of it are among the best supported strategies for mitigating conspiracy theory belief. Ideally, physicians and health care systems should maintain an ongoing “inventory” of medical misinformation circulating online and “beat it to the punch” with reliable information.

Finally, because believing in conspiracy theories is often associated with a sense of uncertainty, and feeling that one’s life is “out of control,” medical interventions can be framed as ways of regaining control and appealing to patients’ values; for example, saying, “By getting the vaccine, you’ll be more likely to stay in good health, protect your family, and do all the things you want to do.”
 

Dr. Pies is professor of psychiatry and a lecturer on bioethics and humanities at State University of New York, Syracuse. Dr. Pierre is a health sciences clinical professor in the department of psychiatry and biobehavioral sciences at the University of California, Los Angeles. A version of this article first appeared on Medscape.com.

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Clinical Edge Commentary: Breast Cancer February 2021

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Dr. Erin Roesch: Results may help inform and encourage patients, providers regarding benefit of various treatments in the setting of toxicities
Dr. Roesch scans the journals so you don't have to!

Erin Roesch, MD

Systemic therapy advances for metastatic breast cancer (MBC) have led to improved overall survival; however, the CNS sanctuary site can be challenging to treat and cause significant neurologic symptoms. Kuksis and colleagues reported that HER2-positive and triple-negative breast MBC subtypes have high incidence of brain metastases, with pooled cumulative incidences of 31% and 32%, respectively. The incidence per patient-year was 13% for both subtypes. The treatment landscape for HER2-positive MBC is rapidly evolving. The combination of tucatinib/capecitabine/trastuzumab demonstrated reduced risk of intracranial progression or death (HR 0.32), improvement in intracranial objective response rate (47.3% versus 20.0%) and reduced risk of death (0.58) in the HER2CLIMB study. An MRI screening program may enhance early detection and study prevention of brain metastases.

Trastuzumab and pertuzumab have significantly improved outcomes in early-stage and advanced HER2-positive breast cancer. These monoclonal antibodies are given with chemotherapy initially, followed by dual antibody therapy to complete one year for curative treatment and until disease progression in the metastatic setting. The FeDeriCa randomized phase 3 study demonstrated that fixed-dose subcutaneous combination of pertuzumab and trastuzumab was non-inferior to intravenous formulations with a geometric mean ratio of cycle 7 pertuzumab serum trough concentration of 1.22 (90% CI 1.14-1.31). Furthermore, efficacy appeared similar with pathologic complete response rates of 60% for both groups. Trastuzumab and pertuzumab administration in an infusion center requires hospital resources, cost, and patient’s time. The MetasphHER study showed that patients preferred subcutaneous trastuzumab compared to IV, and further investigation into long-term outcomes and impact on quality of life and resource allocation is desired.

The phase 3 CLEOPATRA study demonstrated improvement in overall survival with the addition of pertuzumab to docetaxel and trastuzumab in patients with HER2-positive MBC. Rash and diarrhea are well-recognized potential side effects related to pertuzumab. Ferreira et al demonstrated that rash was prognostic for PFS and OS both during and after docetaxel discontinuation, while diarrhea was only prognostic after docetaxel. Neither rash nor diarrhea were predictive of pertuzumab benefit. Studies have shown that patients who developed immune-related adverse events during anti-PD-1 treatment had PFS and OS benefit compared to those who did not. These results may help inform and encourage patients and providers regarding benefit of various treatments in the setting of toxicities. Future research exploring biomarker prognostic and predictive capability is certainly warranted. 

Endocrine therapy plus a CDK 4/6 inhibitor is standard first-line treatment for hormone receptor-positive MBC. Progression that occurs rapidly or through multiple lines of endocrine therapy combinations, may indicate endocrine resistance. The phase 3 PEARL trial did not demonstrate superior PFS among patients with wild type ESR1 AI-resistant MBC with palbociclib/endocrine therapy compared to capecitabine (mPFS 8.0 vs 10.6 months, adjusted HR 1.11; p=0.404); similar PFS and aHR were seen in palbociclib/fulvestrant versus capecitabine cohort. Therapy sequencing in HR+/HER2-negative MBC is indeed relevant, and a previous meta-analysis demonstrated chemotherapy was not better than endocrine therapy plus CDK 4/6 inhibitor in first- or second-line setting. Importantly, palbociclib plus endocrine therapy was associated with better tolerability and quality of life, which should be considered when selecting treatment with similar PFS outcomes.

 

References:

Lin NU, Borges V, Anders C, Murthy RK, Paplomata E, Hamilton E, Hurvitz S, Loi S, Okines A, Abramson V, Bedard PL, Oliveira M, Mueller V, Zelnak A, DiGiovanna MP, Bachelot T, Chien AJ, O'Regan R, Wardley A, Conlin A, Cameron D, Carey L, Curigliano G, Gelmon K, Loibl S, Mayor J, McGoldrick S, An X, Winer EP. Intracranial efficacy and survival with tucatinib plus trastuzumab and capecitabine for previously treated HER2-positive breast cancer with brain metastases in the HER2CLIMB trial. J Clin Oncol. 2020;38:2610-2619.

Pivot X, Spano JP, Espie M, Cottu P, Jouannaud C, Pottier V, Moreau L, Extra JM, Lortholary A, Rivera P, Spaeth D, Attar-Rabia H, Benkanoun C, Dima-Martinez L, Esposito N, Gligorov J. Patients' preference of trastuzumab administration (subcutaneous versus intravenous) in HER2-positive metastatic breast cancer: Results of the randomised MetaspHer study. Eur J Cancer. 2017;82:230-236.

Das S, Ciombor KK, Haraldsdottir S, Pumpalova Y, Sahin IH, Pineda G, Shyr Y, Lin EP, Hsu CY, Chu SK, Goff LW, Cardin DB, Bilen MA, Fisher GA, Wu C, Berlin J. Immune-related adverse events and immune checkpoint inhibitor efficacy in patients with gastrointestinal cancer with Food and Drug Administration-approved indications for immunotherapy. Oncologist. 2020;25:669-679.

Giuliano M, Schettini F, Rognoni C, Milani M, Jerusalem G, Bachelot T, De Laurentiis M, Thomas G, De Placido P, Arpino G, De Placido S, Cristofanilli M, Giordano A, Puglisi F, Pistilli B, Prat A, Del Mastro L, Venturini S, Generali D. Endocrine treatment versus chemotherapy in postmenopausal women with hormone receptor-positive, HER2-negative, metastatic breast cancer: a systematic review and network meta-analysis. Lancet Oncol. 2019;20:1360-1369.

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Erin E. Roesch, MD, Associate Staff, Department of Medical Oncology, Cleveland Clinic, Cleveland, Ohio
Erin E. Roesch, MD, has disclosed the following relevant financial relationships:
Serve(d) as a speaker or a member of a speakers bureau for: Puma Biotechnology

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Erin E. Roesch, MD, Associate Staff, Department of Medical Oncology, Cleveland Clinic, Cleveland, Ohio
Erin E. Roesch, MD, has disclosed the following relevant financial relationships:
Serve(d) as a speaker or a member of a speakers bureau for: Puma Biotechnology

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Erin E. Roesch, MD, Associate Staff, Department of Medical Oncology, Cleveland Clinic, Cleveland, Ohio
Erin E. Roesch, MD, has disclosed the following relevant financial relationships:
Serve(d) as a speaker or a member of a speakers bureau for: Puma Biotechnology

Dr. Roesch scans the journals so you don't have to!
Dr. Roesch scans the journals so you don't have to!

Erin Roesch, MD

Systemic therapy advances for metastatic breast cancer (MBC) have led to improved overall survival; however, the CNS sanctuary site can be challenging to treat and cause significant neurologic symptoms. Kuksis and colleagues reported that HER2-positive and triple-negative breast MBC subtypes have high incidence of brain metastases, with pooled cumulative incidences of 31% and 32%, respectively. The incidence per patient-year was 13% for both subtypes. The treatment landscape for HER2-positive MBC is rapidly evolving. The combination of tucatinib/capecitabine/trastuzumab demonstrated reduced risk of intracranial progression or death (HR 0.32), improvement in intracranial objective response rate (47.3% versus 20.0%) and reduced risk of death (0.58) in the HER2CLIMB study. An MRI screening program may enhance early detection and study prevention of brain metastases.

Trastuzumab and pertuzumab have significantly improved outcomes in early-stage and advanced HER2-positive breast cancer. These monoclonal antibodies are given with chemotherapy initially, followed by dual antibody therapy to complete one year for curative treatment and until disease progression in the metastatic setting. The FeDeriCa randomized phase 3 study demonstrated that fixed-dose subcutaneous combination of pertuzumab and trastuzumab was non-inferior to intravenous formulations with a geometric mean ratio of cycle 7 pertuzumab serum trough concentration of 1.22 (90% CI 1.14-1.31). Furthermore, efficacy appeared similar with pathologic complete response rates of 60% for both groups. Trastuzumab and pertuzumab administration in an infusion center requires hospital resources, cost, and patient’s time. The MetasphHER study showed that patients preferred subcutaneous trastuzumab compared to IV, and further investigation into long-term outcomes and impact on quality of life and resource allocation is desired.

The phase 3 CLEOPATRA study demonstrated improvement in overall survival with the addition of pertuzumab to docetaxel and trastuzumab in patients with HER2-positive MBC. Rash and diarrhea are well-recognized potential side effects related to pertuzumab. Ferreira et al demonstrated that rash was prognostic for PFS and OS both during and after docetaxel discontinuation, while diarrhea was only prognostic after docetaxel. Neither rash nor diarrhea were predictive of pertuzumab benefit. Studies have shown that patients who developed immune-related adverse events during anti-PD-1 treatment had PFS and OS benefit compared to those who did not. These results may help inform and encourage patients and providers regarding benefit of various treatments in the setting of toxicities. Future research exploring biomarker prognostic and predictive capability is certainly warranted. 

Endocrine therapy plus a CDK 4/6 inhibitor is standard first-line treatment for hormone receptor-positive MBC. Progression that occurs rapidly or through multiple lines of endocrine therapy combinations, may indicate endocrine resistance. The phase 3 PEARL trial did not demonstrate superior PFS among patients with wild type ESR1 AI-resistant MBC with palbociclib/endocrine therapy compared to capecitabine (mPFS 8.0 vs 10.6 months, adjusted HR 1.11; p=0.404); similar PFS and aHR were seen in palbociclib/fulvestrant versus capecitabine cohort. Therapy sequencing in HR+/HER2-negative MBC is indeed relevant, and a previous meta-analysis demonstrated chemotherapy was not better than endocrine therapy plus CDK 4/6 inhibitor in first- or second-line setting. Importantly, palbociclib plus endocrine therapy was associated with better tolerability and quality of life, which should be considered when selecting treatment with similar PFS outcomes.

 

References:

Lin NU, Borges V, Anders C, Murthy RK, Paplomata E, Hamilton E, Hurvitz S, Loi S, Okines A, Abramson V, Bedard PL, Oliveira M, Mueller V, Zelnak A, DiGiovanna MP, Bachelot T, Chien AJ, O'Regan R, Wardley A, Conlin A, Cameron D, Carey L, Curigliano G, Gelmon K, Loibl S, Mayor J, McGoldrick S, An X, Winer EP. Intracranial efficacy and survival with tucatinib plus trastuzumab and capecitabine for previously treated HER2-positive breast cancer with brain metastases in the HER2CLIMB trial. J Clin Oncol. 2020;38:2610-2619.

Pivot X, Spano JP, Espie M, Cottu P, Jouannaud C, Pottier V, Moreau L, Extra JM, Lortholary A, Rivera P, Spaeth D, Attar-Rabia H, Benkanoun C, Dima-Martinez L, Esposito N, Gligorov J. Patients' preference of trastuzumab administration (subcutaneous versus intravenous) in HER2-positive metastatic breast cancer: Results of the randomised MetaspHer study. Eur J Cancer. 2017;82:230-236.

Das S, Ciombor KK, Haraldsdottir S, Pumpalova Y, Sahin IH, Pineda G, Shyr Y, Lin EP, Hsu CY, Chu SK, Goff LW, Cardin DB, Bilen MA, Fisher GA, Wu C, Berlin J. Immune-related adverse events and immune checkpoint inhibitor efficacy in patients with gastrointestinal cancer with Food and Drug Administration-approved indications for immunotherapy. Oncologist. 2020;25:669-679.

Giuliano M, Schettini F, Rognoni C, Milani M, Jerusalem G, Bachelot T, De Laurentiis M, Thomas G, De Placido P, Arpino G, De Placido S, Cristofanilli M, Giordano A, Puglisi F, Pistilli B, Prat A, Del Mastro L, Venturini S, Generali D. Endocrine treatment versus chemotherapy in postmenopausal women with hormone receptor-positive, HER2-negative, metastatic breast cancer: a systematic review and network meta-analysis. Lancet Oncol. 2019;20:1360-1369.

Erin Roesch, MD

Systemic therapy advances for metastatic breast cancer (MBC) have led to improved overall survival; however, the CNS sanctuary site can be challenging to treat and cause significant neurologic symptoms. Kuksis and colleagues reported that HER2-positive and triple-negative breast MBC subtypes have high incidence of brain metastases, with pooled cumulative incidences of 31% and 32%, respectively. The incidence per patient-year was 13% for both subtypes. The treatment landscape for HER2-positive MBC is rapidly evolving. The combination of tucatinib/capecitabine/trastuzumab demonstrated reduced risk of intracranial progression or death (HR 0.32), improvement in intracranial objective response rate (47.3% versus 20.0%) and reduced risk of death (0.58) in the HER2CLIMB study. An MRI screening program may enhance early detection and study prevention of brain metastases.

Trastuzumab and pertuzumab have significantly improved outcomes in early-stage and advanced HER2-positive breast cancer. These monoclonal antibodies are given with chemotherapy initially, followed by dual antibody therapy to complete one year for curative treatment and until disease progression in the metastatic setting. The FeDeriCa randomized phase 3 study demonstrated that fixed-dose subcutaneous combination of pertuzumab and trastuzumab was non-inferior to intravenous formulations with a geometric mean ratio of cycle 7 pertuzumab serum trough concentration of 1.22 (90% CI 1.14-1.31). Furthermore, efficacy appeared similar with pathologic complete response rates of 60% for both groups. Trastuzumab and pertuzumab administration in an infusion center requires hospital resources, cost, and patient’s time. The MetasphHER study showed that patients preferred subcutaneous trastuzumab compared to IV, and further investigation into long-term outcomes and impact on quality of life and resource allocation is desired.

The phase 3 CLEOPATRA study demonstrated improvement in overall survival with the addition of pertuzumab to docetaxel and trastuzumab in patients with HER2-positive MBC. Rash and diarrhea are well-recognized potential side effects related to pertuzumab. Ferreira et al demonstrated that rash was prognostic for PFS and OS both during and after docetaxel discontinuation, while diarrhea was only prognostic after docetaxel. Neither rash nor diarrhea were predictive of pertuzumab benefit. Studies have shown that patients who developed immune-related adverse events during anti-PD-1 treatment had PFS and OS benefit compared to those who did not. These results may help inform and encourage patients and providers regarding benefit of various treatments in the setting of toxicities. Future research exploring biomarker prognostic and predictive capability is certainly warranted. 

Endocrine therapy plus a CDK 4/6 inhibitor is standard first-line treatment for hormone receptor-positive MBC. Progression that occurs rapidly or through multiple lines of endocrine therapy combinations, may indicate endocrine resistance. The phase 3 PEARL trial did not demonstrate superior PFS among patients with wild type ESR1 AI-resistant MBC with palbociclib/endocrine therapy compared to capecitabine (mPFS 8.0 vs 10.6 months, adjusted HR 1.11; p=0.404); similar PFS and aHR were seen in palbociclib/fulvestrant versus capecitabine cohort. Therapy sequencing in HR+/HER2-negative MBC is indeed relevant, and a previous meta-analysis demonstrated chemotherapy was not better than endocrine therapy plus CDK 4/6 inhibitor in first- or second-line setting. Importantly, palbociclib plus endocrine therapy was associated with better tolerability and quality of life, which should be considered when selecting treatment with similar PFS outcomes.

 

References:

Lin NU, Borges V, Anders C, Murthy RK, Paplomata E, Hamilton E, Hurvitz S, Loi S, Okines A, Abramson V, Bedard PL, Oliveira M, Mueller V, Zelnak A, DiGiovanna MP, Bachelot T, Chien AJ, O'Regan R, Wardley A, Conlin A, Cameron D, Carey L, Curigliano G, Gelmon K, Loibl S, Mayor J, McGoldrick S, An X, Winer EP. Intracranial efficacy and survival with tucatinib plus trastuzumab and capecitabine for previously treated HER2-positive breast cancer with brain metastases in the HER2CLIMB trial. J Clin Oncol. 2020;38:2610-2619.

Pivot X, Spano JP, Espie M, Cottu P, Jouannaud C, Pottier V, Moreau L, Extra JM, Lortholary A, Rivera P, Spaeth D, Attar-Rabia H, Benkanoun C, Dima-Martinez L, Esposito N, Gligorov J. Patients' preference of trastuzumab administration (subcutaneous versus intravenous) in HER2-positive metastatic breast cancer: Results of the randomised MetaspHer study. Eur J Cancer. 2017;82:230-236.

Das S, Ciombor KK, Haraldsdottir S, Pumpalova Y, Sahin IH, Pineda G, Shyr Y, Lin EP, Hsu CY, Chu SK, Goff LW, Cardin DB, Bilen MA, Fisher GA, Wu C, Berlin J. Immune-related adverse events and immune checkpoint inhibitor efficacy in patients with gastrointestinal cancer with Food and Drug Administration-approved indications for immunotherapy. Oncologist. 2020;25:669-679.

Giuliano M, Schettini F, Rognoni C, Milani M, Jerusalem G, Bachelot T, De Laurentiis M, Thomas G, De Placido P, Arpino G, De Placido S, Cristofanilli M, Giordano A, Puglisi F, Pistilli B, Prat A, Del Mastro L, Venturini S, Generali D. Endocrine treatment versus chemotherapy in postmenopausal women with hormone receptor-positive, HER2-negative, metastatic breast cancer: a systematic review and network meta-analysis. Lancet Oncol. 2019;20:1360-1369.

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COVID-19 cases dropping in U.S., but variants threaten progress

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COVID-19 cases are continuing to fall in the United States, according to the New York Times tracker, though the number of deaths from the disease again neared 4,000 on Feb. 3.

janiecbros/iStock/Getty Images Plus

The United States has averaged 141,146 cases a day in the past week, down 30% from the average 2 weeks ago. For the first time since November 2020, the country is averaging fewer than 150,000 cases a day, according to the tracker.

However, Rochelle Walensky, MD, MPH, director of the Centers for Disease Control and Prevention, warned that new COVID-19 variants popping up widely could threaten that progress.

“Although we have seen declines in cases and admissions and a recent slowing of deaths, cases remain extraordinarily high, still twice as high as the peak number of cases over the summer. And the continued proliferation of variants, variants that likely have increased transmissibility, that spread more easily, threatens to reverse these recent trends.

“Based on contact tracing of recent variant cases, not wearing masks and participating in in-person social gatherings have contributed to the variants’ spread,” she said at a White House COVID-19 briefing on Feb. 3, 2021.

The number of cases worldwide neared 104 million on Feb. 3 and the U.S. numbers made up 26.4 million of that total.

As of Feb. 4, COVID-19 had killed at least 454,000 people and infected about 26.6 million in the United States since January 2020, according to the Johns Hopkins University tracker.

The Johns Hopkins tracker found that, per capita, North Dakota, South Dakota, and Rhode Island have reported the most cases while New Jersey and New York have recorded the most deaths.

According to the COVID tracking project, hospitalizations for COVID-19 nationwide were down to 91,440 on Feb. 3.

The tracking report noted, “compared to last week, the number of people currently hospitalized with COVID-19 is down by 10% or more in 38 states.”

Even in hard-hit Los Angeles County, infections and case numbers are on the decline, according to the Los Angeles Times. However, officials, warn the numbers remain well above presurge levels. Over the past week, 201 city residents have died every day.

Reuters also reports that Anthony S. Fauci, MD, the government’s top infectious disease expert, said despite some good news in the numbers, Americans should continue to follow social distancing guidelines. He added that double-masking may add protection.

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

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COVID-19 cases are continuing to fall in the United States, according to the New York Times tracker, though the number of deaths from the disease again neared 4,000 on Feb. 3.

janiecbros/iStock/Getty Images Plus

The United States has averaged 141,146 cases a day in the past week, down 30% from the average 2 weeks ago. For the first time since November 2020, the country is averaging fewer than 150,000 cases a day, according to the tracker.

However, Rochelle Walensky, MD, MPH, director of the Centers for Disease Control and Prevention, warned that new COVID-19 variants popping up widely could threaten that progress.

“Although we have seen declines in cases and admissions and a recent slowing of deaths, cases remain extraordinarily high, still twice as high as the peak number of cases over the summer. And the continued proliferation of variants, variants that likely have increased transmissibility, that spread more easily, threatens to reverse these recent trends.

“Based on contact tracing of recent variant cases, not wearing masks and participating in in-person social gatherings have contributed to the variants’ spread,” she said at a White House COVID-19 briefing on Feb. 3, 2021.

The number of cases worldwide neared 104 million on Feb. 3 and the U.S. numbers made up 26.4 million of that total.

As of Feb. 4, COVID-19 had killed at least 454,000 people and infected about 26.6 million in the United States since January 2020, according to the Johns Hopkins University tracker.

The Johns Hopkins tracker found that, per capita, North Dakota, South Dakota, and Rhode Island have reported the most cases while New Jersey and New York have recorded the most deaths.

According to the COVID tracking project, hospitalizations for COVID-19 nationwide were down to 91,440 on Feb. 3.

The tracking report noted, “compared to last week, the number of people currently hospitalized with COVID-19 is down by 10% or more in 38 states.”

Even in hard-hit Los Angeles County, infections and case numbers are on the decline, according to the Los Angeles Times. However, officials, warn the numbers remain well above presurge levels. Over the past week, 201 city residents have died every day.

Reuters also reports that Anthony S. Fauci, MD, the government’s top infectious disease expert, said despite some good news in the numbers, Americans should continue to follow social distancing guidelines. He added that double-masking may add protection.

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

COVID-19 cases are continuing to fall in the United States, according to the New York Times tracker, though the number of deaths from the disease again neared 4,000 on Feb. 3.

janiecbros/iStock/Getty Images Plus

The United States has averaged 141,146 cases a day in the past week, down 30% from the average 2 weeks ago. For the first time since November 2020, the country is averaging fewer than 150,000 cases a day, according to the tracker.

However, Rochelle Walensky, MD, MPH, director of the Centers for Disease Control and Prevention, warned that new COVID-19 variants popping up widely could threaten that progress.

“Although we have seen declines in cases and admissions and a recent slowing of deaths, cases remain extraordinarily high, still twice as high as the peak number of cases over the summer. And the continued proliferation of variants, variants that likely have increased transmissibility, that spread more easily, threatens to reverse these recent trends.

“Based on contact tracing of recent variant cases, not wearing masks and participating in in-person social gatherings have contributed to the variants’ spread,” she said at a White House COVID-19 briefing on Feb. 3, 2021.

The number of cases worldwide neared 104 million on Feb. 3 and the U.S. numbers made up 26.4 million of that total.

As of Feb. 4, COVID-19 had killed at least 454,000 people and infected about 26.6 million in the United States since January 2020, according to the Johns Hopkins University tracker.

The Johns Hopkins tracker found that, per capita, North Dakota, South Dakota, and Rhode Island have reported the most cases while New Jersey and New York have recorded the most deaths.

According to the COVID tracking project, hospitalizations for COVID-19 nationwide were down to 91,440 on Feb. 3.

The tracking report noted, “compared to last week, the number of people currently hospitalized with COVID-19 is down by 10% or more in 38 states.”

Even in hard-hit Los Angeles County, infections and case numbers are on the decline, according to the Los Angeles Times. However, officials, warn the numbers remain well above presurge levels. Over the past week, 201 city residents have died every day.

Reuters also reports that Anthony S. Fauci, MD, the government’s top infectious disease expert, said despite some good news in the numbers, Americans should continue to follow social distancing guidelines. He added that double-masking may add protection.

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

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Views on ethical issues shifting in family, internal medicine

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Internal medicine physicians’ and family physicians’ attitudes have changed in recent years on several ethical issues, according to the Medscape Internal Medicine Ethics Report 2020 and the corresponding report for Family Medicine.

An example comes in an apparent loosening of attitudes about romantic/sexual relationships with former patients. Now, 31% of internists believe such a relationship is acceptable at least 6 months after the medical relationship has ended. That’s up from 22% in 2018. The number of family physicians this year who said 6 months later was acceptable also increased, but by a smaller margin – from 28% in 2018 to 33% in 2020.

“It’s acceptable as long as there is no undue influence,” David Fleming, MD, a member of the American Medical Association Council on Ethical and Judicial Affairs, said in an interview. “The important thing is that you don’t mix the two.”
 

Thoughts on upcoding

Views on billing are also shifting. Ten years ago, 17% of physicians overall thought upcoding was acceptable when submitting claims or getting prior authorization. Today just 8% of physicians overall said it was, as did 8% of family medicine (FM) physicians, according to responses.

The number of internal medicine (IM) physicians clearly opposed to upcoding declined a bit from 79% in 2018 to 75% this year, while the number saying “it depends” increased from 11% to 15%.

Many responders in both specialties said they would upgrade a code in the interest of patient advocacy.

An internist put it this way: “If the system is set up so that the only thing that would work for the patient’s condition can be obtained by an upcode, then I would consider this.”
 

More than a third say random drug checks needed

More than one-third of physicians in both specialties (34% in IM and 38% in FM) said physicians should be subjected to random alcohol and drug testing.

However, many say testing should only happen if abuse is suspected.

Some said specialty matters when it comes to random checks. An internist responded: “I think this is more important for procedure-based physicians.”

Some family physicians said that, if other health care workers were subjected to the same checks in the same circumstances, they would not object, but said doctors shouldn’t be singled out.
 

Vast majority would report an impaired peer

Nine out of 10 internists and family physicians say they would report a physician who occasionally seemed impaired but most (60% of IM respondents and 62% of FM respondents) said they would do so only after talking with the physician first.

Some noted their decision would depend on the setting.

“Big difference if they are on vacation and drink too much so they need a ride home versus being impaired at work or when on call,” one FM physician said.

About one-third of family physicians (34%) and internists (33%) now favor physician-assisted dying/suicide for incurable suffering. A substantial number (26%-28%) hesitated to make a clear decision in both specialties, responding “it depends.”

“Patient control over quality of life can be even more important than control over its quantity/duration,” one internist wrote.

The proportion of physicians who agreed physician-assisted dying/suicide should be legalized for the terminally ill was much larger, with 49% of family physicians and 52% of IM physicians saying it should.
 

 

 

Talking politics

Data in this survey were collected in summer months of 2020, before the U.S. presidential election, in a highly polarized climate. Some numbers reflect increasing distaste for such conversations with patients.

For example, the number of family physicians who said talking about politics with patients was ethical dropped from 31% in 2018 to 23% in the latest survey. The numbers remained nearly flat among IM physicians in the past 2 years – at 21% in 2018 and 23% this year.
 

Should a flu shot be mandatory?

Almost three-fourths of physicians overall – and 76% of IM physicians – say annual flu shots should be required for physicians who have patient contact. Agreement was somewhat lower among family physicians at 68%.

Some family physicians cited “freedom of choice” and that they would want to see a higher effectiveness rate before they were mandatory.

Data for this survey, with 5,130 respondents, were collected before COVID-19 vaccines became available.

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

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Internal medicine physicians’ and family physicians’ attitudes have changed in recent years on several ethical issues, according to the Medscape Internal Medicine Ethics Report 2020 and the corresponding report for Family Medicine.

An example comes in an apparent loosening of attitudes about romantic/sexual relationships with former patients. Now, 31% of internists believe such a relationship is acceptable at least 6 months after the medical relationship has ended. That’s up from 22% in 2018. The number of family physicians this year who said 6 months later was acceptable also increased, but by a smaller margin – from 28% in 2018 to 33% in 2020.

“It’s acceptable as long as there is no undue influence,” David Fleming, MD, a member of the American Medical Association Council on Ethical and Judicial Affairs, said in an interview. “The important thing is that you don’t mix the two.”
 

Thoughts on upcoding

Views on billing are also shifting. Ten years ago, 17% of physicians overall thought upcoding was acceptable when submitting claims or getting prior authorization. Today just 8% of physicians overall said it was, as did 8% of family medicine (FM) physicians, according to responses.

The number of internal medicine (IM) physicians clearly opposed to upcoding declined a bit from 79% in 2018 to 75% this year, while the number saying “it depends” increased from 11% to 15%.

Many responders in both specialties said they would upgrade a code in the interest of patient advocacy.

An internist put it this way: “If the system is set up so that the only thing that would work for the patient’s condition can be obtained by an upcode, then I would consider this.”
 

More than a third say random drug checks needed

More than one-third of physicians in both specialties (34% in IM and 38% in FM) said physicians should be subjected to random alcohol and drug testing.

However, many say testing should only happen if abuse is suspected.

Some said specialty matters when it comes to random checks. An internist responded: “I think this is more important for procedure-based physicians.”

Some family physicians said that, if other health care workers were subjected to the same checks in the same circumstances, they would not object, but said doctors shouldn’t be singled out.
 

Vast majority would report an impaired peer

Nine out of 10 internists and family physicians say they would report a physician who occasionally seemed impaired but most (60% of IM respondents and 62% of FM respondents) said they would do so only after talking with the physician first.

Some noted their decision would depend on the setting.

“Big difference if they are on vacation and drink too much so they need a ride home versus being impaired at work or when on call,” one FM physician said.

About one-third of family physicians (34%) and internists (33%) now favor physician-assisted dying/suicide for incurable suffering. A substantial number (26%-28%) hesitated to make a clear decision in both specialties, responding “it depends.”

“Patient control over quality of life can be even more important than control over its quantity/duration,” one internist wrote.

The proportion of physicians who agreed physician-assisted dying/suicide should be legalized for the terminally ill was much larger, with 49% of family physicians and 52% of IM physicians saying it should.
 

 

 

Talking politics

Data in this survey were collected in summer months of 2020, before the U.S. presidential election, in a highly polarized climate. Some numbers reflect increasing distaste for such conversations with patients.

For example, the number of family physicians who said talking about politics with patients was ethical dropped from 31% in 2018 to 23% in the latest survey. The numbers remained nearly flat among IM physicians in the past 2 years – at 21% in 2018 and 23% this year.
 

Should a flu shot be mandatory?

Almost three-fourths of physicians overall – and 76% of IM physicians – say annual flu shots should be required for physicians who have patient contact. Agreement was somewhat lower among family physicians at 68%.

Some family physicians cited “freedom of choice” and that they would want to see a higher effectiveness rate before they were mandatory.

Data for this survey, with 5,130 respondents, were collected before COVID-19 vaccines became available.

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

Internal medicine physicians’ and family physicians’ attitudes have changed in recent years on several ethical issues, according to the Medscape Internal Medicine Ethics Report 2020 and the corresponding report for Family Medicine.

An example comes in an apparent loosening of attitudes about romantic/sexual relationships with former patients. Now, 31% of internists believe such a relationship is acceptable at least 6 months after the medical relationship has ended. That’s up from 22% in 2018. The number of family physicians this year who said 6 months later was acceptable also increased, but by a smaller margin – from 28% in 2018 to 33% in 2020.

“It’s acceptable as long as there is no undue influence,” David Fleming, MD, a member of the American Medical Association Council on Ethical and Judicial Affairs, said in an interview. “The important thing is that you don’t mix the two.”
 

Thoughts on upcoding

Views on billing are also shifting. Ten years ago, 17% of physicians overall thought upcoding was acceptable when submitting claims or getting prior authorization. Today just 8% of physicians overall said it was, as did 8% of family medicine (FM) physicians, according to responses.

The number of internal medicine (IM) physicians clearly opposed to upcoding declined a bit from 79% in 2018 to 75% this year, while the number saying “it depends” increased from 11% to 15%.

Many responders in both specialties said they would upgrade a code in the interest of patient advocacy.

An internist put it this way: “If the system is set up so that the only thing that would work for the patient’s condition can be obtained by an upcode, then I would consider this.”
 

More than a third say random drug checks needed

More than one-third of physicians in both specialties (34% in IM and 38% in FM) said physicians should be subjected to random alcohol and drug testing.

However, many say testing should only happen if abuse is suspected.

Some said specialty matters when it comes to random checks. An internist responded: “I think this is more important for procedure-based physicians.”

Some family physicians said that, if other health care workers were subjected to the same checks in the same circumstances, they would not object, but said doctors shouldn’t be singled out.
 

Vast majority would report an impaired peer

Nine out of 10 internists and family physicians say they would report a physician who occasionally seemed impaired but most (60% of IM respondents and 62% of FM respondents) said they would do so only after talking with the physician first.

Some noted their decision would depend on the setting.

“Big difference if they are on vacation and drink too much so they need a ride home versus being impaired at work or when on call,” one FM physician said.

About one-third of family physicians (34%) and internists (33%) now favor physician-assisted dying/suicide for incurable suffering. A substantial number (26%-28%) hesitated to make a clear decision in both specialties, responding “it depends.”

“Patient control over quality of life can be even more important than control over its quantity/duration,” one internist wrote.

The proportion of physicians who agreed physician-assisted dying/suicide should be legalized for the terminally ill was much larger, with 49% of family physicians and 52% of IM physicians saying it should.
 

 

 

Talking politics

Data in this survey were collected in summer months of 2020, before the U.S. presidential election, in a highly polarized climate. Some numbers reflect increasing distaste for such conversations with patients.

For example, the number of family physicians who said talking about politics with patients was ethical dropped from 31% in 2018 to 23% in the latest survey. The numbers remained nearly flat among IM physicians in the past 2 years – at 21% in 2018 and 23% this year.
 

Should a flu shot be mandatory?

Almost three-fourths of physicians overall – and 76% of IM physicians – say annual flu shots should be required for physicians who have patient contact. Agreement was somewhat lower among family physicians at 68%.

Some family physicians cited “freedom of choice” and that they would want to see a higher effectiveness rate before they were mandatory.

Data for this survey, with 5,130 respondents, were collected before COVID-19 vaccines became available.

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

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AGA Clinical Practice Update: Bariatric surgery in patients with cirrhosis

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Obesity, a risk factor for nonalcoholic fatty liver disease (NAFLD) and a prevalent comorbidity among people with cirrhosis of all etiologies, is associated with a number of untoward health outcomes, and weight loss is an important goal, according to a clinical practice update from the American Gastroenterological Association. According to one study cited in the update, approximately 30% of patients with cirrhosis have comorbid obesity, and this figure may increase even further as the epidemic of NAFLD progresses.

For obese patients with cirrhosis, weight loss “is an important therapeutic goal” because obesity heightens risks of portal vein thrombosis, portal hypertension, hepatocellular carcinoma, liver failure in acute on chronic liver disease, and other concerns. Despite no longer being an absolute contraindication, obesity can also complicate liver transplantation considerations, Heather Patton, MD, of the Veterans Affairs San Diego Healthcare System and associates wrote in Clinical Gastroenterology and Hepatology. Consideration of individuals with cirrhosis, however, requires careful scrutiny of surgical candidacy, appropriate resources for care of patients with advanced liver disease, and a high-volume bariatric surgical center given the inherent risks of surgical procedures in this patient population.

For patients with cirrhosis and obesity, laparoscopic sleeve gastrectomy is probably the best option for bariatric surgery because it preserves endoscopic access to the biliary tree, facilitates gradual weight loss, and does not cause malabsorption, according to the update.

Clinicians and patients should time bariatric surgery based on liver disease stage – for patients with decompensated disease, surgery should be performed only at the same time as or after liver transplantation, the experts wrote. Clinicians should also evaluate candidacy for liver transplantation before bariatric surgery “so that patients who are ineligible for transplant (and their families) have a clear understanding of this, avoiding the need for the medical team to address this issue urgently if the patient’s condition deteriorates postoperatively.”

One review suggested that bariatric surgery is “the most effective and durable” means of weight loss, according to the authors of the update; however, another review suggested increased surgical risk for bariatric surgery among patients with cirrhosis, so the update’s authors advised individualized risk-benefit assessments. These assessments are made even more complicated by scarcity of relevant randomized trial data, so the experts identified PubMed-indexed, peer-reviewed articles published between 2000 and 2020 and used these to make 10 best practice advice statements for bariatric surgery in obese patients with cirrhosis.

The surgical, anesthesia, and medical teams must be well versed in assessing and operating on patients with portal hypertension and cirrhosis and in managing these patients postoperatively, the experts wrote. The preoperative assessment should include cirrhosis status (compensated versus decompensated), the presence and severity of sarcopenia, ascites, and portal hypertension, and candidacy for liver transplantation. It is vital to check for clinically significant portal hypertension (CSPH) because endoscopic devices should not be used in patients with gastric and/or esophageal varices. To do so, upper endoscopy and cross-sectional imaging are advised, pending better data on noninvasive assessment methods. For patients without CSPH, endoscopic bariatric treatment can be somewhat less effective for weight loss but also might be less likely to lead to postoperative complications. However, head-to-head and long-term safety data are not yet available.

The experts also noted that bariatric surgery increases the effects (blood levels) of alcohol and can increase patients’ risk for developing an alcohol use disorder. Therefore, clinicians should carefully the history of alcohol use and repeatedly educate patients about the risks of consuming alcohol after bariatric surgery. According to a study from 2012 and a review from 2015, male sex, younger age, less social support, and regular or “problematic” alcohol use before bariatric surgery heighten the risk for developing an alcohol use disorder afterward, the experts noted.

Funding sources included the Robert H. Yauk Charitable Trust Gift for Liver Transplant Research 2017-2020 and Regenerative Medicine for Prevention of Post-Transplant Biliary Complications. The authors reported having no conflicts of interest.

This article was updated Feb. 23, 2021.

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Obesity, a risk factor for nonalcoholic fatty liver disease (NAFLD) and a prevalent comorbidity among people with cirrhosis of all etiologies, is associated with a number of untoward health outcomes, and weight loss is an important goal, according to a clinical practice update from the American Gastroenterological Association. According to one study cited in the update, approximately 30% of patients with cirrhosis have comorbid obesity, and this figure may increase even further as the epidemic of NAFLD progresses.

For obese patients with cirrhosis, weight loss “is an important therapeutic goal” because obesity heightens risks of portal vein thrombosis, portal hypertension, hepatocellular carcinoma, liver failure in acute on chronic liver disease, and other concerns. Despite no longer being an absolute contraindication, obesity can also complicate liver transplantation considerations, Heather Patton, MD, of the Veterans Affairs San Diego Healthcare System and associates wrote in Clinical Gastroenterology and Hepatology. Consideration of individuals with cirrhosis, however, requires careful scrutiny of surgical candidacy, appropriate resources for care of patients with advanced liver disease, and a high-volume bariatric surgical center given the inherent risks of surgical procedures in this patient population.

For patients with cirrhosis and obesity, laparoscopic sleeve gastrectomy is probably the best option for bariatric surgery because it preserves endoscopic access to the biliary tree, facilitates gradual weight loss, and does not cause malabsorption, according to the update.

Clinicians and patients should time bariatric surgery based on liver disease stage – for patients with decompensated disease, surgery should be performed only at the same time as or after liver transplantation, the experts wrote. Clinicians should also evaluate candidacy for liver transplantation before bariatric surgery “so that patients who are ineligible for transplant (and their families) have a clear understanding of this, avoiding the need for the medical team to address this issue urgently if the patient’s condition deteriorates postoperatively.”

One review suggested that bariatric surgery is “the most effective and durable” means of weight loss, according to the authors of the update; however, another review suggested increased surgical risk for bariatric surgery among patients with cirrhosis, so the update’s authors advised individualized risk-benefit assessments. These assessments are made even more complicated by scarcity of relevant randomized trial data, so the experts identified PubMed-indexed, peer-reviewed articles published between 2000 and 2020 and used these to make 10 best practice advice statements for bariatric surgery in obese patients with cirrhosis.

The surgical, anesthesia, and medical teams must be well versed in assessing and operating on patients with portal hypertension and cirrhosis and in managing these patients postoperatively, the experts wrote. The preoperative assessment should include cirrhosis status (compensated versus decompensated), the presence and severity of sarcopenia, ascites, and portal hypertension, and candidacy for liver transplantation. It is vital to check for clinically significant portal hypertension (CSPH) because endoscopic devices should not be used in patients with gastric and/or esophageal varices. To do so, upper endoscopy and cross-sectional imaging are advised, pending better data on noninvasive assessment methods. For patients without CSPH, endoscopic bariatric treatment can be somewhat less effective for weight loss but also might be less likely to lead to postoperative complications. However, head-to-head and long-term safety data are not yet available.

The experts also noted that bariatric surgery increases the effects (blood levels) of alcohol and can increase patients’ risk for developing an alcohol use disorder. Therefore, clinicians should carefully the history of alcohol use and repeatedly educate patients about the risks of consuming alcohol after bariatric surgery. According to a study from 2012 and a review from 2015, male sex, younger age, less social support, and regular or “problematic” alcohol use before bariatric surgery heighten the risk for developing an alcohol use disorder afterward, the experts noted.

Funding sources included the Robert H. Yauk Charitable Trust Gift for Liver Transplant Research 2017-2020 and Regenerative Medicine for Prevention of Post-Transplant Biliary Complications. The authors reported having no conflicts of interest.

This article was updated Feb. 23, 2021.

 

Obesity, a risk factor for nonalcoholic fatty liver disease (NAFLD) and a prevalent comorbidity among people with cirrhosis of all etiologies, is associated with a number of untoward health outcomes, and weight loss is an important goal, according to a clinical practice update from the American Gastroenterological Association. According to one study cited in the update, approximately 30% of patients with cirrhosis have comorbid obesity, and this figure may increase even further as the epidemic of NAFLD progresses.

For obese patients with cirrhosis, weight loss “is an important therapeutic goal” because obesity heightens risks of portal vein thrombosis, portal hypertension, hepatocellular carcinoma, liver failure in acute on chronic liver disease, and other concerns. Despite no longer being an absolute contraindication, obesity can also complicate liver transplantation considerations, Heather Patton, MD, of the Veterans Affairs San Diego Healthcare System and associates wrote in Clinical Gastroenterology and Hepatology. Consideration of individuals with cirrhosis, however, requires careful scrutiny of surgical candidacy, appropriate resources for care of patients with advanced liver disease, and a high-volume bariatric surgical center given the inherent risks of surgical procedures in this patient population.

For patients with cirrhosis and obesity, laparoscopic sleeve gastrectomy is probably the best option for bariatric surgery because it preserves endoscopic access to the biliary tree, facilitates gradual weight loss, and does not cause malabsorption, according to the update.

Clinicians and patients should time bariatric surgery based on liver disease stage – for patients with decompensated disease, surgery should be performed only at the same time as or after liver transplantation, the experts wrote. Clinicians should also evaluate candidacy for liver transplantation before bariatric surgery “so that patients who are ineligible for transplant (and their families) have a clear understanding of this, avoiding the need for the medical team to address this issue urgently if the patient’s condition deteriorates postoperatively.”

One review suggested that bariatric surgery is “the most effective and durable” means of weight loss, according to the authors of the update; however, another review suggested increased surgical risk for bariatric surgery among patients with cirrhosis, so the update’s authors advised individualized risk-benefit assessments. These assessments are made even more complicated by scarcity of relevant randomized trial data, so the experts identified PubMed-indexed, peer-reviewed articles published between 2000 and 2020 and used these to make 10 best practice advice statements for bariatric surgery in obese patients with cirrhosis.

The surgical, anesthesia, and medical teams must be well versed in assessing and operating on patients with portal hypertension and cirrhosis and in managing these patients postoperatively, the experts wrote. The preoperative assessment should include cirrhosis status (compensated versus decompensated), the presence and severity of sarcopenia, ascites, and portal hypertension, and candidacy for liver transplantation. It is vital to check for clinically significant portal hypertension (CSPH) because endoscopic devices should not be used in patients with gastric and/or esophageal varices. To do so, upper endoscopy and cross-sectional imaging are advised, pending better data on noninvasive assessment methods. For patients without CSPH, endoscopic bariatric treatment can be somewhat less effective for weight loss but also might be less likely to lead to postoperative complications. However, head-to-head and long-term safety data are not yet available.

The experts also noted that bariatric surgery increases the effects (blood levels) of alcohol and can increase patients’ risk for developing an alcohol use disorder. Therefore, clinicians should carefully the history of alcohol use and repeatedly educate patients about the risks of consuming alcohol after bariatric surgery. According to a study from 2012 and a review from 2015, male sex, younger age, less social support, and regular or “problematic” alcohol use before bariatric surgery heighten the risk for developing an alcohol use disorder afterward, the experts noted.

Funding sources included the Robert H. Yauk Charitable Trust Gift for Liver Transplant Research 2017-2020 and Regenerative Medicine for Prevention of Post-Transplant Biliary Complications. The authors reported having no conflicts of interest.

This article was updated Feb. 23, 2021.

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FDA alert confirms heart and cancer risks with tofacitinib (Xeljanz)

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The Food and Drug Administration has alerted the public to an increased risk of serious heart-related problems and cancer risk associated with the Janus kinase inhibitor tofacitinib (Xeljanz, Xeljanz XR), based on early results from a safety clinical trial comparing tofacitinib and tumor necrosis factor inhibitors in patients with rheumatoid arthritis (RA).

The FDA is awaiting further results from the trial, but in a safety communication issued on Feb. 4, the agency advised patients not to discontinue tofacitinib without consulting their health care providers and advised health care professionals to weigh the risks and benefits when prescribing the drug and continue to follow the current prescribing information.

Tofacitinib was approved for treatment of RA in 2012 at a 5-mg dose. After this approval, the FDA required drug manufacturer Pfizer to conduct a safety clinical trial that included the 5-mg twice-daily dose and a 10-mg twice-daily dose that is currently approved only for ulcerative colitis. In addition to RA and ulcerative colitis, tofacitinib is approved for adults with active psoriatic arthritis and patients aged 2 years or older with active polyarticular course juvenile idiopathic arthritis.



Pfizer announced partial results of the study, known as the ORAL Surveillance trial, in a press release on Jan. 27. The randomized trial included 4,362 RA patients aged 50 years and older who received either 5-mg or 10-mg doses of tofacitinib or a TNF inhibitor (adalimumab or etanercept).

The full results have yet to be released, but based on data from approximately 10,000 person-years for the combined tofacitinib groups and approximately 5,000 person-years for the TNF inhibitor group, the rate of major cardiovascular adverse events was significantly higher in the combined tofacitinib group, compared with the TNF inhibitor group (0.98 vs. 0.73 per 100 person-years; hazard ratio, 1.33). In addition, the rate of adjudicated malignancies was significantly higher in the tofacitinib group, compared with the TNF inhibitor group (1.13 vs. 0.77 per 100 person-years; HR, 1.48).



In February 2019, the FDA issued a warning stating an increased risk of pulmonary embolism and death associated with the 10-mg twice-daily dose of tofacitinib, following interims results from the safety study.

In July 2019, the FDA added a boxed warning to tofacitinib advising of the increased risk for pulmonary embolism and death associated with the 10-mg twice-daily dose.

The FDA encouraged health care professionals and patients to report any side effects from tofacitinib or other medications through the FDA MedWatch program online or by phone at 1-800-332-1088.

Until nuances revealed, no change in practice


The preliminary study findings contain some nuances that are a bit complicated from a statistical standpoint, according to Daniel Furst, MD, professor emeritus of medicine at the University of California, Los Angeles; adjunct professor at the University of Washington, Seattle; and research professor at the University of Florence (Italy).

Dr. Daniel E. Furst

This is supposed to be a noninferiority study, so something might not be noninferior, “but that doesn’t mean it is inferior,” explained Dr. Furst, who is also a member of the MDedge Rheumatology Editorial Advisory Board.
Dr. Furst said he was surprised by the study findings, because “I didn’t expect there to be any differences, and in fact it is not clear how great the differences are” among the groups in the study, he said.
When the complete findings are released, in one of the instances, “the statistics may show a very small statistical difference that indicates we may have to be more careful in this particularly high-risk group,” Dr. Furst noted.
“When we understand the data more closely, we may find that there are some nuances we need to be careful about,” he said. However, “until those data are out, I would not make any changes in my practice.”
Whether the current study findings represent a class effect is “impossible to say,” since tofacitinib affects three enzymes, while other JAK inhibitors affect only one or two, he noted.
Dr. Furst disclosed receiving grant/research support from and/or consulting for AbbVie, Actelion, Amgen, Bristol-Myers Squibb, Corbus, the National Institutes of Health, Novartis, Pfizer, and Roche/Genentech.

Updated on 2/8/2021.

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The Food and Drug Administration has alerted the public to an increased risk of serious heart-related problems and cancer risk associated with the Janus kinase inhibitor tofacitinib (Xeljanz, Xeljanz XR), based on early results from a safety clinical trial comparing tofacitinib and tumor necrosis factor inhibitors in patients with rheumatoid arthritis (RA).

The FDA is awaiting further results from the trial, but in a safety communication issued on Feb. 4, the agency advised patients not to discontinue tofacitinib without consulting their health care providers and advised health care professionals to weigh the risks and benefits when prescribing the drug and continue to follow the current prescribing information.

Tofacitinib was approved for treatment of RA in 2012 at a 5-mg dose. After this approval, the FDA required drug manufacturer Pfizer to conduct a safety clinical trial that included the 5-mg twice-daily dose and a 10-mg twice-daily dose that is currently approved only for ulcerative colitis. In addition to RA and ulcerative colitis, tofacitinib is approved for adults with active psoriatic arthritis and patients aged 2 years or older with active polyarticular course juvenile idiopathic arthritis.



Pfizer announced partial results of the study, known as the ORAL Surveillance trial, in a press release on Jan. 27. The randomized trial included 4,362 RA patients aged 50 years and older who received either 5-mg or 10-mg doses of tofacitinib or a TNF inhibitor (adalimumab or etanercept).

The full results have yet to be released, but based on data from approximately 10,000 person-years for the combined tofacitinib groups and approximately 5,000 person-years for the TNF inhibitor group, the rate of major cardiovascular adverse events was significantly higher in the combined tofacitinib group, compared with the TNF inhibitor group (0.98 vs. 0.73 per 100 person-years; hazard ratio, 1.33). In addition, the rate of adjudicated malignancies was significantly higher in the tofacitinib group, compared with the TNF inhibitor group (1.13 vs. 0.77 per 100 person-years; HR, 1.48).



In February 2019, the FDA issued a warning stating an increased risk of pulmonary embolism and death associated with the 10-mg twice-daily dose of tofacitinib, following interims results from the safety study.

In July 2019, the FDA added a boxed warning to tofacitinib advising of the increased risk for pulmonary embolism and death associated with the 10-mg twice-daily dose.

The FDA encouraged health care professionals and patients to report any side effects from tofacitinib or other medications through the FDA MedWatch program online or by phone at 1-800-332-1088.

Until nuances revealed, no change in practice


The preliminary study findings contain some nuances that are a bit complicated from a statistical standpoint, according to Daniel Furst, MD, professor emeritus of medicine at the University of California, Los Angeles; adjunct professor at the University of Washington, Seattle; and research professor at the University of Florence (Italy).

Dr. Daniel E. Furst

This is supposed to be a noninferiority study, so something might not be noninferior, “but that doesn’t mean it is inferior,” explained Dr. Furst, who is also a member of the MDedge Rheumatology Editorial Advisory Board.
Dr. Furst said he was surprised by the study findings, because “I didn’t expect there to be any differences, and in fact it is not clear how great the differences are” among the groups in the study, he said.
When the complete findings are released, in one of the instances, “the statistics may show a very small statistical difference that indicates we may have to be more careful in this particularly high-risk group,” Dr. Furst noted.
“When we understand the data more closely, we may find that there are some nuances we need to be careful about,” he said. However, “until those data are out, I would not make any changes in my practice.”
Whether the current study findings represent a class effect is “impossible to say,” since tofacitinib affects three enzymes, while other JAK inhibitors affect only one or two, he noted.
Dr. Furst disclosed receiving grant/research support from and/or consulting for AbbVie, Actelion, Amgen, Bristol-Myers Squibb, Corbus, the National Institutes of Health, Novartis, Pfizer, and Roche/Genentech.

Updated on 2/8/2021.

The Food and Drug Administration has alerted the public to an increased risk of serious heart-related problems and cancer risk associated with the Janus kinase inhibitor tofacitinib (Xeljanz, Xeljanz XR), based on early results from a safety clinical trial comparing tofacitinib and tumor necrosis factor inhibitors in patients with rheumatoid arthritis (RA).

The FDA is awaiting further results from the trial, but in a safety communication issued on Feb. 4, the agency advised patients not to discontinue tofacitinib without consulting their health care providers and advised health care professionals to weigh the risks and benefits when prescribing the drug and continue to follow the current prescribing information.

Tofacitinib was approved for treatment of RA in 2012 at a 5-mg dose. After this approval, the FDA required drug manufacturer Pfizer to conduct a safety clinical trial that included the 5-mg twice-daily dose and a 10-mg twice-daily dose that is currently approved only for ulcerative colitis. In addition to RA and ulcerative colitis, tofacitinib is approved for adults with active psoriatic arthritis and patients aged 2 years or older with active polyarticular course juvenile idiopathic arthritis.



Pfizer announced partial results of the study, known as the ORAL Surveillance trial, in a press release on Jan. 27. The randomized trial included 4,362 RA patients aged 50 years and older who received either 5-mg or 10-mg doses of tofacitinib or a TNF inhibitor (adalimumab or etanercept).

The full results have yet to be released, but based on data from approximately 10,000 person-years for the combined tofacitinib groups and approximately 5,000 person-years for the TNF inhibitor group, the rate of major cardiovascular adverse events was significantly higher in the combined tofacitinib group, compared with the TNF inhibitor group (0.98 vs. 0.73 per 100 person-years; hazard ratio, 1.33). In addition, the rate of adjudicated malignancies was significantly higher in the tofacitinib group, compared with the TNF inhibitor group (1.13 vs. 0.77 per 100 person-years; HR, 1.48).



In February 2019, the FDA issued a warning stating an increased risk of pulmonary embolism and death associated with the 10-mg twice-daily dose of tofacitinib, following interims results from the safety study.

In July 2019, the FDA added a boxed warning to tofacitinib advising of the increased risk for pulmonary embolism and death associated with the 10-mg twice-daily dose.

The FDA encouraged health care professionals and patients to report any side effects from tofacitinib or other medications through the FDA MedWatch program online or by phone at 1-800-332-1088.

Until nuances revealed, no change in practice


The preliminary study findings contain some nuances that are a bit complicated from a statistical standpoint, according to Daniel Furst, MD, professor emeritus of medicine at the University of California, Los Angeles; adjunct professor at the University of Washington, Seattle; and research professor at the University of Florence (Italy).

Dr. Daniel E. Furst

This is supposed to be a noninferiority study, so something might not be noninferior, “but that doesn’t mean it is inferior,” explained Dr. Furst, who is also a member of the MDedge Rheumatology Editorial Advisory Board.
Dr. Furst said he was surprised by the study findings, because “I didn’t expect there to be any differences, and in fact it is not clear how great the differences are” among the groups in the study, he said.
When the complete findings are released, in one of the instances, “the statistics may show a very small statistical difference that indicates we may have to be more careful in this particularly high-risk group,” Dr. Furst noted.
“When we understand the data more closely, we may find that there are some nuances we need to be careful about,” he said. However, “until those data are out, I would not make any changes in my practice.”
Whether the current study findings represent a class effect is “impossible to say,” since tofacitinib affects three enzymes, while other JAK inhibitors affect only one or two, he noted.
Dr. Furst disclosed receiving grant/research support from and/or consulting for AbbVie, Actelion, Amgen, Bristol-Myers Squibb, Corbus, the National Institutes of Health, Novartis, Pfizer, and Roche/Genentech.

Updated on 2/8/2021.

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Antidepressant may help COVID-19 patients avoid serious illness

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The antidepressant fluvoxamine shows promise in preventing people infected with coronavirus from developing serious symptoms and having to be hospitalized, according to a nonrandomized study of California racetrack workers.

Dr. Caline Mattar

“What we observed was that of all the patients who received fluvoxamine, none of them had a severe COVID infection that affected their lungs or their respiratory status,” Caline Mattar, MD, told KNBC in Los Angeles. Dr. Mattar is an infectious disease researcher at Washington University in St. Louis who helped conduct the study that was published in Open Forum Infectious Diseases.

Fluvoxamine, which is sold under the brand name Luvox, is a selective serotonin reuptake inhibitor (SSRI) often prescribed for people diagnosed with obsessive-compulsive disorder. It’s been on the market for over a decade.

Two-hundred employees at Golden Gate Fields Racetrack in Berkeley, Calif., tested positive for COVID-19 last November. Track physician David Seftel, MD, offered fluvoxamine to 113 of them, having learned of a previous randomized study of COVID-19 patients that indicated fluvoxamine helped ward off serious illness, Science News said.

The 65 workers who took a 2-week course of the drug didn’t have to be hospitalized, didn’t have serious symptoms, and felt better after 2 weeks, the study said. Six of the 48 workers who turned down fluvoxamine had to be hospitalized, two required intensive care, and one died, the study said.

“Overall, fluvoxamine appears promising as early treatment for COVID-19 to prevent clinical deterioration requiring hospitalization and to prevent possible long haul symptoms persisting beyond 2 weeks,” the study said.

The authors stressed that their findings were “a real world evidence study” necessitated by the urgency of the coronavirus pandemic.

They said their research needed verification from a randomized, controlled trial. Such a study is now being conducted by Washington University and other schools, KNBC said.

The track workers who were infected were predominantly male and Latino, and 30% had chronic medical problems such as diabetes or high blood pressure, Science News said.

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

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The antidepressant fluvoxamine shows promise in preventing people infected with coronavirus from developing serious symptoms and having to be hospitalized, according to a nonrandomized study of California racetrack workers.

Dr. Caline Mattar

“What we observed was that of all the patients who received fluvoxamine, none of them had a severe COVID infection that affected their lungs or their respiratory status,” Caline Mattar, MD, told KNBC in Los Angeles. Dr. Mattar is an infectious disease researcher at Washington University in St. Louis who helped conduct the study that was published in Open Forum Infectious Diseases.

Fluvoxamine, which is sold under the brand name Luvox, is a selective serotonin reuptake inhibitor (SSRI) often prescribed for people diagnosed with obsessive-compulsive disorder. It’s been on the market for over a decade.

Two-hundred employees at Golden Gate Fields Racetrack in Berkeley, Calif., tested positive for COVID-19 last November. Track physician David Seftel, MD, offered fluvoxamine to 113 of them, having learned of a previous randomized study of COVID-19 patients that indicated fluvoxamine helped ward off serious illness, Science News said.

The 65 workers who took a 2-week course of the drug didn’t have to be hospitalized, didn’t have serious symptoms, and felt better after 2 weeks, the study said. Six of the 48 workers who turned down fluvoxamine had to be hospitalized, two required intensive care, and one died, the study said.

“Overall, fluvoxamine appears promising as early treatment for COVID-19 to prevent clinical deterioration requiring hospitalization and to prevent possible long haul symptoms persisting beyond 2 weeks,” the study said.

The authors stressed that their findings were “a real world evidence study” necessitated by the urgency of the coronavirus pandemic.

They said their research needed verification from a randomized, controlled trial. Such a study is now being conducted by Washington University and other schools, KNBC said.

The track workers who were infected were predominantly male and Latino, and 30% had chronic medical problems such as diabetes or high blood pressure, Science News said.

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

The antidepressant fluvoxamine shows promise in preventing people infected with coronavirus from developing serious symptoms and having to be hospitalized, according to a nonrandomized study of California racetrack workers.

Dr. Caline Mattar

“What we observed was that of all the patients who received fluvoxamine, none of them had a severe COVID infection that affected their lungs or their respiratory status,” Caline Mattar, MD, told KNBC in Los Angeles. Dr. Mattar is an infectious disease researcher at Washington University in St. Louis who helped conduct the study that was published in Open Forum Infectious Diseases.

Fluvoxamine, which is sold under the brand name Luvox, is a selective serotonin reuptake inhibitor (SSRI) often prescribed for people diagnosed with obsessive-compulsive disorder. It’s been on the market for over a decade.

Two-hundred employees at Golden Gate Fields Racetrack in Berkeley, Calif., tested positive for COVID-19 last November. Track physician David Seftel, MD, offered fluvoxamine to 113 of them, having learned of a previous randomized study of COVID-19 patients that indicated fluvoxamine helped ward off serious illness, Science News said.

The 65 workers who took a 2-week course of the drug didn’t have to be hospitalized, didn’t have serious symptoms, and felt better after 2 weeks, the study said. Six of the 48 workers who turned down fluvoxamine had to be hospitalized, two required intensive care, and one died, the study said.

“Overall, fluvoxamine appears promising as early treatment for COVID-19 to prevent clinical deterioration requiring hospitalization and to prevent possible long haul symptoms persisting beyond 2 weeks,” the study said.

The authors stressed that their findings were “a real world evidence study” necessitated by the urgency of the coronavirus pandemic.

They said their research needed verification from a randomized, controlled trial. Such a study is now being conducted by Washington University and other schools, KNBC said.

The track workers who were infected were predominantly male and Latino, and 30% had chronic medical problems such as diabetes or high blood pressure, Science News said.

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

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Investigating the Increase in Group A Streptococcus Among Indigenous Peoples

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Investigating the Increase in Group A Streptococcus Among Indigenous Peoples
First Nations members had more skin and soft tissue infections and, unexpectedly, fewer streptococcal toxic shock syndrome cases.

Invasive group A Streptococcus (iGAS) disease has been on the rise among indigenous populations around the world. Researchers from University of Alberta, Alberta Ministry of Health, both in Edmonton, and Alberta First Nations Information Governance Center in Alberta conducted a study to find out more. Between 2003 and 2017, they investigated iGAS cases among First Nations, Inuit, and Métis members in Alberta.

During that time, 669 cases of iGAS were reported. The incidence increased from 10 cases per 100,000 in 2003 to 52 cases per 100,000 in 2017—an incidence rate > 6 times that of non–First Nations populations. The researchers say the disproportionately high rates are seen in other Native American groups compared with the rates in the general population: One study, for instance, found the incidence rate for Alaska Natives was 13.7 cases per 100,000 compared with 3.9 cases per 100,000 for non–Alaska Natives.

What’s driving the higher rates isn’t completely clear, the researchers say. They note that risk factor data in their study “frequently” indicated nonsurgical wounds, addiction abuse, and homelessness. They also cite research that has found skin infections and skin breakdown are common among iGAS patients who were injection drug users or homeless. Diabetes mellitus—rampant among Native Americans—was another risk factor.

The researchers found a “striking difference” in that the First Nations members had more skin and soft tissue infections and, unexpectedly, fewer streptococcal toxic shock syndrome cases than did the non–First Nations groups.

Moreover, skin-to-skin transmission may be more common than respiratory transmission: When they grouped emm types (the bacteria are typed according to a protein encoded by the emm gene) by cluster, they found the bulk of disease among the First Nations population was associated with skin-related infections, not throat-related clusters. This may be a consequence of overcrowded households or inadequate housing, both issues for Native American communities. The researchers say emm59, the most prevalent emm type in the First Nations population in the study, displays a tropism for skin infections. Since 2006, they add, when a large outbreak of emm59 was reported, it has become common throughout western Canada and the US, where it had previously been relatively rare.

Of note, the researchers conclude, substantial emm differences could have potential implications for future vaccine.

Source: Tyrrell GJ, Bell B, Bill L, Fathima S. Increasing incidence of invasive group A Streptococcus Disease in First Nations population, Alberta, Canada, 2003-2017. Emerg Infect Dis. 2021;27(2):443-451. doi:doi:10.3201/eid2702.20194

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First Nations members had more skin and soft tissue infections and, unexpectedly, fewer streptococcal toxic shock syndrome cases.
First Nations members had more skin and soft tissue infections and, unexpectedly, fewer streptococcal toxic shock syndrome cases.

Invasive group A Streptococcus (iGAS) disease has been on the rise among indigenous populations around the world. Researchers from University of Alberta, Alberta Ministry of Health, both in Edmonton, and Alberta First Nations Information Governance Center in Alberta conducted a study to find out more. Between 2003 and 2017, they investigated iGAS cases among First Nations, Inuit, and Métis members in Alberta.

During that time, 669 cases of iGAS were reported. The incidence increased from 10 cases per 100,000 in 2003 to 52 cases per 100,000 in 2017—an incidence rate > 6 times that of non–First Nations populations. The researchers say the disproportionately high rates are seen in other Native American groups compared with the rates in the general population: One study, for instance, found the incidence rate for Alaska Natives was 13.7 cases per 100,000 compared with 3.9 cases per 100,000 for non–Alaska Natives.

What’s driving the higher rates isn’t completely clear, the researchers say. They note that risk factor data in their study “frequently” indicated nonsurgical wounds, addiction abuse, and homelessness. They also cite research that has found skin infections and skin breakdown are common among iGAS patients who were injection drug users or homeless. Diabetes mellitus—rampant among Native Americans—was another risk factor.

The researchers found a “striking difference” in that the First Nations members had more skin and soft tissue infections and, unexpectedly, fewer streptococcal toxic shock syndrome cases than did the non–First Nations groups.

Moreover, skin-to-skin transmission may be more common than respiratory transmission: When they grouped emm types (the bacteria are typed according to a protein encoded by the emm gene) by cluster, they found the bulk of disease among the First Nations population was associated with skin-related infections, not throat-related clusters. This may be a consequence of overcrowded households or inadequate housing, both issues for Native American communities. The researchers say emm59, the most prevalent emm type in the First Nations population in the study, displays a tropism for skin infections. Since 2006, they add, when a large outbreak of emm59 was reported, it has become common throughout western Canada and the US, where it had previously been relatively rare.

Of note, the researchers conclude, substantial emm differences could have potential implications for future vaccine.

Source: Tyrrell GJ, Bell B, Bill L, Fathima S. Increasing incidence of invasive group A Streptococcus Disease in First Nations population, Alberta, Canada, 2003-2017. Emerg Infect Dis. 2021;27(2):443-451. doi:doi:10.3201/eid2702.20194

Invasive group A Streptococcus (iGAS) disease has been on the rise among indigenous populations around the world. Researchers from University of Alberta, Alberta Ministry of Health, both in Edmonton, and Alberta First Nations Information Governance Center in Alberta conducted a study to find out more. Between 2003 and 2017, they investigated iGAS cases among First Nations, Inuit, and Métis members in Alberta.

During that time, 669 cases of iGAS were reported. The incidence increased from 10 cases per 100,000 in 2003 to 52 cases per 100,000 in 2017—an incidence rate > 6 times that of non–First Nations populations. The researchers say the disproportionately high rates are seen in other Native American groups compared with the rates in the general population: One study, for instance, found the incidence rate for Alaska Natives was 13.7 cases per 100,000 compared with 3.9 cases per 100,000 for non–Alaska Natives.

What’s driving the higher rates isn’t completely clear, the researchers say. They note that risk factor data in their study “frequently” indicated nonsurgical wounds, addiction abuse, and homelessness. They also cite research that has found skin infections and skin breakdown are common among iGAS patients who were injection drug users or homeless. Diabetes mellitus—rampant among Native Americans—was another risk factor.

The researchers found a “striking difference” in that the First Nations members had more skin and soft tissue infections and, unexpectedly, fewer streptococcal toxic shock syndrome cases than did the non–First Nations groups.

Moreover, skin-to-skin transmission may be more common than respiratory transmission: When they grouped emm types (the bacteria are typed according to a protein encoded by the emm gene) by cluster, they found the bulk of disease among the First Nations population was associated with skin-related infections, not throat-related clusters. This may be a consequence of overcrowded households or inadequate housing, both issues for Native American communities. The researchers say emm59, the most prevalent emm type in the First Nations population in the study, displays a tropism for skin infections. Since 2006, they add, when a large outbreak of emm59 was reported, it has become common throughout western Canada and the US, where it had previously been relatively rare.

Of note, the researchers conclude, substantial emm differences could have potential implications for future vaccine.

Source: Tyrrell GJ, Bell B, Bill L, Fathima S. Increasing incidence of invasive group A Streptococcus Disease in First Nations population, Alberta, Canada, 2003-2017. Emerg Infect Dis. 2021;27(2):443-451. doi:doi:10.3201/eid2702.20194

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Survey finds practice gaps in counseling women with hidradenitis suppurativa about pregnancy

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Many women with hidradenitis suppurativa have pregnancy-related concerns that go unaddressed by their doctors, according to a study that surveyed 59 women with HS.

Previous studies have shown the potential for adverse pregnancy outcomes associated with inflammatory conditions such as systemic vasculitis and lupus, but such data on HS and pregnancy are limited, which makes patient counseling a challenge, Ademide A. Adelekun, MD, of the University of Pennsylvania, Philadelphia, and colleagues wrote.

In a research letter published in JAMA Dermatology, they reported their findings from an email survey of female patients at two academic dermatology departments. A total of 59 women responded to the survey; their average age was 32 years, the majority (76%) had Hurley stage II disease, and 29 (49%) reported having ever been pregnant.

Two of the 29 women (7%) were pregnant at the time of the study survey; 20 of the other 27 pregnant women (74%) said they had full-term births, 4 (15%) reported miscarriages, and 3 (11%) had undergone an abortion.

A total of five patients (9%) reported difficulty getting pregnant after 1 year, and seven (12%) reported undergoing fertility treatments.

Nearly three-quarters of the women (73%) reported that HS had a negative impact on their sexual health, and 54% said they wished their doctors provided more counseling on HS and pregnancy.

A total of 14 patients (24%) said they believed HS affected their ability to become pregnant because of either decreased sexual activity or decreased fertility caused by HS medications, and nearly half (49%) said they believed that discontinuing all HS medications during pregnancy was necessary for safety reasons.



Patients also expressed concern about the possible heritability of HS: 80% said that physicians had not counseled them about HS heritability and 68% expressed concern that their child would have HS.

In addition, 83% said they had not received information about the potential impact of HS on pregnancy, and 22%, or 13 women, were concerned that childbirth would be more difficult; 11 of these 13 women (85%) had HS that affected the vulva and groin, and 4 of the 8 women who reported concerns about difficulty breastfeeding had HS that involved the breast.

Of the 59 patients surveyed, 12 (20%) said they believed HS poses risks to the child, including through transmission of HS in 8 (67%) or through an infection during a vaginal delivery in 7 women (58%).

The prevalence of HS patients’ concerns about pregnancy “may have unfavorable implications for family planning and mental health and may play a role in the inadequate treatment of HS in patients who are pregnant or planning to become pregnant,” the authors noted. “Family planning and prenatal counseling are particularly critical for those with HS given that clinicians weigh the risks of medication use against the benefits of disease control, which is associated with improved pregnancy outcomes for those with inflammatory conditions.”

The study findings were limited by several factors including “recall bias, low response rate, use of a nonvalidated survey, and generalizability to nonacademic settings,” the researchers noted. However, the results emphasize the often-underrecognized concerns of women with HS and the need for improvements in pregnancy-related counseling and systematic evaluation of outcomes.

The researchers had no financial conflicts to disclose. This study was funded by a FOCUS Medical Student Fellowship in Women’s Health grant.

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Many women with hidradenitis suppurativa have pregnancy-related concerns that go unaddressed by their doctors, according to a study that surveyed 59 women with HS.

Previous studies have shown the potential for adverse pregnancy outcomes associated with inflammatory conditions such as systemic vasculitis and lupus, but such data on HS and pregnancy are limited, which makes patient counseling a challenge, Ademide A. Adelekun, MD, of the University of Pennsylvania, Philadelphia, and colleagues wrote.

In a research letter published in JAMA Dermatology, they reported their findings from an email survey of female patients at two academic dermatology departments. A total of 59 women responded to the survey; their average age was 32 years, the majority (76%) had Hurley stage II disease, and 29 (49%) reported having ever been pregnant.

Two of the 29 women (7%) were pregnant at the time of the study survey; 20 of the other 27 pregnant women (74%) said they had full-term births, 4 (15%) reported miscarriages, and 3 (11%) had undergone an abortion.

A total of five patients (9%) reported difficulty getting pregnant after 1 year, and seven (12%) reported undergoing fertility treatments.

Nearly three-quarters of the women (73%) reported that HS had a negative impact on their sexual health, and 54% said they wished their doctors provided more counseling on HS and pregnancy.

A total of 14 patients (24%) said they believed HS affected their ability to become pregnant because of either decreased sexual activity or decreased fertility caused by HS medications, and nearly half (49%) said they believed that discontinuing all HS medications during pregnancy was necessary for safety reasons.



Patients also expressed concern about the possible heritability of HS: 80% said that physicians had not counseled them about HS heritability and 68% expressed concern that their child would have HS.

In addition, 83% said they had not received information about the potential impact of HS on pregnancy, and 22%, or 13 women, were concerned that childbirth would be more difficult; 11 of these 13 women (85%) had HS that affected the vulva and groin, and 4 of the 8 women who reported concerns about difficulty breastfeeding had HS that involved the breast.

Of the 59 patients surveyed, 12 (20%) said they believed HS poses risks to the child, including through transmission of HS in 8 (67%) or through an infection during a vaginal delivery in 7 women (58%).

The prevalence of HS patients’ concerns about pregnancy “may have unfavorable implications for family planning and mental health and may play a role in the inadequate treatment of HS in patients who are pregnant or planning to become pregnant,” the authors noted. “Family planning and prenatal counseling are particularly critical for those with HS given that clinicians weigh the risks of medication use against the benefits of disease control, which is associated with improved pregnancy outcomes for those with inflammatory conditions.”

The study findings were limited by several factors including “recall bias, low response rate, use of a nonvalidated survey, and generalizability to nonacademic settings,” the researchers noted. However, the results emphasize the often-underrecognized concerns of women with HS and the need for improvements in pregnancy-related counseling and systematic evaluation of outcomes.

The researchers had no financial conflicts to disclose. This study was funded by a FOCUS Medical Student Fellowship in Women’s Health grant.

Many women with hidradenitis suppurativa have pregnancy-related concerns that go unaddressed by their doctors, according to a study that surveyed 59 women with HS.

Previous studies have shown the potential for adverse pregnancy outcomes associated with inflammatory conditions such as systemic vasculitis and lupus, but such data on HS and pregnancy are limited, which makes patient counseling a challenge, Ademide A. Adelekun, MD, of the University of Pennsylvania, Philadelphia, and colleagues wrote.

In a research letter published in JAMA Dermatology, they reported their findings from an email survey of female patients at two academic dermatology departments. A total of 59 women responded to the survey; their average age was 32 years, the majority (76%) had Hurley stage II disease, and 29 (49%) reported having ever been pregnant.

Two of the 29 women (7%) were pregnant at the time of the study survey; 20 of the other 27 pregnant women (74%) said they had full-term births, 4 (15%) reported miscarriages, and 3 (11%) had undergone an abortion.

A total of five patients (9%) reported difficulty getting pregnant after 1 year, and seven (12%) reported undergoing fertility treatments.

Nearly three-quarters of the women (73%) reported that HS had a negative impact on their sexual health, and 54% said they wished their doctors provided more counseling on HS and pregnancy.

A total of 14 patients (24%) said they believed HS affected their ability to become pregnant because of either decreased sexual activity or decreased fertility caused by HS medications, and nearly half (49%) said they believed that discontinuing all HS medications during pregnancy was necessary for safety reasons.



Patients also expressed concern about the possible heritability of HS: 80% said that physicians had not counseled them about HS heritability and 68% expressed concern that their child would have HS.

In addition, 83% said they had not received information about the potential impact of HS on pregnancy, and 22%, or 13 women, were concerned that childbirth would be more difficult; 11 of these 13 women (85%) had HS that affected the vulva and groin, and 4 of the 8 women who reported concerns about difficulty breastfeeding had HS that involved the breast.

Of the 59 patients surveyed, 12 (20%) said they believed HS poses risks to the child, including through transmission of HS in 8 (67%) or through an infection during a vaginal delivery in 7 women (58%).

The prevalence of HS patients’ concerns about pregnancy “may have unfavorable implications for family planning and mental health and may play a role in the inadequate treatment of HS in patients who are pregnant or planning to become pregnant,” the authors noted. “Family planning and prenatal counseling are particularly critical for those with HS given that clinicians weigh the risks of medication use against the benefits of disease control, which is associated with improved pregnancy outcomes for those with inflammatory conditions.”

The study findings were limited by several factors including “recall bias, low response rate, use of a nonvalidated survey, and generalizability to nonacademic settings,” the researchers noted. However, the results emphasize the often-underrecognized concerns of women with HS and the need for improvements in pregnancy-related counseling and systematic evaluation of outcomes.

The researchers had no financial conflicts to disclose. This study was funded by a FOCUS Medical Student Fellowship in Women’s Health grant.

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New campaign fights COVID-19 vaccine disinformation

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As health care providers work against the clock to administer as many COVID-19 vaccine doses as soon as possible, logistics aren’t the only thing standing in their way.

Misinformation – which has hampered the nation’s coronavirus response – is now hurting vaccination efforts, too.

About one in five Americans say they won’t take a COVID-19 vaccine, according to the Kaiser Family Foundation’s COVID-19 Vaccine Monitor. Even a third of health care workers have voiced their hesitance.

The spread of COVID-19 vaccine misinformation creates “a really powerful parallel pandemic to the real pandemic,” Imran Ahmed, CEO of the Center for Countering Digital Hate, told NPR. The center has tracked the links between vaccine misinformation and vaccine hesitancy during the past year.

The “infodemic” is essentially “working in concert to really undermine our capacity to contain COVID,” Mr. Ahmed said.

To help combat vaccine misinformation and address lingering concerns that people have, corporate, nonprofit, and media leaders, including this news organization, are joining a public service campaign called VaxFacts. Led by HealthGuard, the goal of the campaign is to provide facts and tools to help consumers make informed decisions about vaccines.

Steven Brill, co-CEO of HealthGuard, said credible information that comes from trusted messengers is critical to counter vaccine hesitancy.

“There’s traditionally a lot of skepticism about vaccines. That has really ramped up in the last few years based on campaigns about the measles vaccine. ... And now you have the COVID vaccine, which by everybody’s understanding has been ‘rushed,’ ” Mr. Brill said during an interview on Coronavirus in Context, a video series hosted by John Whyte, MD, chief medical officer for WebMD.

“There may be less understanding of the nature of what rushed really means. It’s still gone through the clinical trials it needs to go through.”

HealthGuard is a browser extension that flags health hoaxes, provides credibility ratings for hundreds of websites, and guides users to sources that offer trusted information. The tool is a new service from NewsGuard, which veteran journalists Mr. Brill and co-CEO Gordon Crovitz created in 2018 to combat misinformation in the news. HealthGuard, which is free for users globally through June, is specifically aimed at informing readers about health myths related to vaccines and COVID-19. It will cost $35 per year after that.

The HealthGuard Coronavirus Tracking Center has flagged nearly 400 websites for publishing misinformation about the coronavirus, including several top myths about COVID-19 vaccines:

  • The mRNA vaccines can alter human DNA.
  • Vaccines will use microchip surveillance technology.
  • COVID-19 vaccines cause infertility.
  • The vaccine developed by Oxford University will turn people into monkeys.
  • COVID-19 vaccines contain aborted human fetal tissue.

As a partner, this news organization will feature continuing coverage of COVID-19 vaccine misinformation, including articles and videos.

There will be other efforts this year. Google has launched a $3 million fund to back fact-checking organizations to counter vaccine misinformation, and social media platforms are monitoring posts that actively promote disinformation around vaccines.

The United States has distributed nearly 50 million vaccine doses, and states have administered more than 32 million of them, including 5.9 million second doses in the two-shot vaccines, according to the latest CDC update.

To reach herd immunity, about 75%-85% of Americans will need to receive a vaccine, Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, said in December 2020.

Vaccine skepticism has increased in recent years, which has led to a decline in vaccination rates and the highest annual number of measles cases in the United States in more than 25 years, according to the Pew Research Center. In 2019, the World Health Organization named vaccine hesitancy as 1 of 10 threats to global health.

With the COVID-19 vaccines in particular, people have voiced concerns about their safety and how well they work, given their accelerated development, according to Kaiser’s poll. They’re also worried about potential side effects, the perceived role of politics in the development process, and a lack of trust in government. Others don’t trust vaccines in general or believe they may contract COVID-19 from a vaccine, the Kaiser poll found, “suggesting that messages combating particular types of misinformation may be especially important for increasing vaccine confidence.”

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

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As health care providers work against the clock to administer as many COVID-19 vaccine doses as soon as possible, logistics aren’t the only thing standing in their way.

Misinformation – which has hampered the nation’s coronavirus response – is now hurting vaccination efforts, too.

About one in five Americans say they won’t take a COVID-19 vaccine, according to the Kaiser Family Foundation’s COVID-19 Vaccine Monitor. Even a third of health care workers have voiced their hesitance.

The spread of COVID-19 vaccine misinformation creates “a really powerful parallel pandemic to the real pandemic,” Imran Ahmed, CEO of the Center for Countering Digital Hate, told NPR. The center has tracked the links between vaccine misinformation and vaccine hesitancy during the past year.

The “infodemic” is essentially “working in concert to really undermine our capacity to contain COVID,” Mr. Ahmed said.

To help combat vaccine misinformation and address lingering concerns that people have, corporate, nonprofit, and media leaders, including this news organization, are joining a public service campaign called VaxFacts. Led by HealthGuard, the goal of the campaign is to provide facts and tools to help consumers make informed decisions about vaccines.

Steven Brill, co-CEO of HealthGuard, said credible information that comes from trusted messengers is critical to counter vaccine hesitancy.

“There’s traditionally a lot of skepticism about vaccines. That has really ramped up in the last few years based on campaigns about the measles vaccine. ... And now you have the COVID vaccine, which by everybody’s understanding has been ‘rushed,’ ” Mr. Brill said during an interview on Coronavirus in Context, a video series hosted by John Whyte, MD, chief medical officer for WebMD.

“There may be less understanding of the nature of what rushed really means. It’s still gone through the clinical trials it needs to go through.”

HealthGuard is a browser extension that flags health hoaxes, provides credibility ratings for hundreds of websites, and guides users to sources that offer trusted information. The tool is a new service from NewsGuard, which veteran journalists Mr. Brill and co-CEO Gordon Crovitz created in 2018 to combat misinformation in the news. HealthGuard, which is free for users globally through June, is specifically aimed at informing readers about health myths related to vaccines and COVID-19. It will cost $35 per year after that.

The HealthGuard Coronavirus Tracking Center has flagged nearly 400 websites for publishing misinformation about the coronavirus, including several top myths about COVID-19 vaccines:

  • The mRNA vaccines can alter human DNA.
  • Vaccines will use microchip surveillance technology.
  • COVID-19 vaccines cause infertility.
  • The vaccine developed by Oxford University will turn people into monkeys.
  • COVID-19 vaccines contain aborted human fetal tissue.

As a partner, this news organization will feature continuing coverage of COVID-19 vaccine misinformation, including articles and videos.

There will be other efforts this year. Google has launched a $3 million fund to back fact-checking organizations to counter vaccine misinformation, and social media platforms are monitoring posts that actively promote disinformation around vaccines.

The United States has distributed nearly 50 million vaccine doses, and states have administered more than 32 million of them, including 5.9 million second doses in the two-shot vaccines, according to the latest CDC update.

To reach herd immunity, about 75%-85% of Americans will need to receive a vaccine, Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, said in December 2020.

Vaccine skepticism has increased in recent years, which has led to a decline in vaccination rates and the highest annual number of measles cases in the United States in more than 25 years, according to the Pew Research Center. In 2019, the World Health Organization named vaccine hesitancy as 1 of 10 threats to global health.

With the COVID-19 vaccines in particular, people have voiced concerns about their safety and how well they work, given their accelerated development, according to Kaiser’s poll. They’re also worried about potential side effects, the perceived role of politics in the development process, and a lack of trust in government. Others don’t trust vaccines in general or believe they may contract COVID-19 from a vaccine, the Kaiser poll found, “suggesting that messages combating particular types of misinformation may be especially important for increasing vaccine confidence.”

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

 

As health care providers work against the clock to administer as many COVID-19 vaccine doses as soon as possible, logistics aren’t the only thing standing in their way.

Misinformation – which has hampered the nation’s coronavirus response – is now hurting vaccination efforts, too.

About one in five Americans say they won’t take a COVID-19 vaccine, according to the Kaiser Family Foundation’s COVID-19 Vaccine Monitor. Even a third of health care workers have voiced their hesitance.

The spread of COVID-19 vaccine misinformation creates “a really powerful parallel pandemic to the real pandemic,” Imran Ahmed, CEO of the Center for Countering Digital Hate, told NPR. The center has tracked the links between vaccine misinformation and vaccine hesitancy during the past year.

The “infodemic” is essentially “working in concert to really undermine our capacity to contain COVID,” Mr. Ahmed said.

To help combat vaccine misinformation and address lingering concerns that people have, corporate, nonprofit, and media leaders, including this news organization, are joining a public service campaign called VaxFacts. Led by HealthGuard, the goal of the campaign is to provide facts and tools to help consumers make informed decisions about vaccines.

Steven Brill, co-CEO of HealthGuard, said credible information that comes from trusted messengers is critical to counter vaccine hesitancy.

“There’s traditionally a lot of skepticism about vaccines. That has really ramped up in the last few years based on campaigns about the measles vaccine. ... And now you have the COVID vaccine, which by everybody’s understanding has been ‘rushed,’ ” Mr. Brill said during an interview on Coronavirus in Context, a video series hosted by John Whyte, MD, chief medical officer for WebMD.

“There may be less understanding of the nature of what rushed really means. It’s still gone through the clinical trials it needs to go through.”

HealthGuard is a browser extension that flags health hoaxes, provides credibility ratings for hundreds of websites, and guides users to sources that offer trusted information. The tool is a new service from NewsGuard, which veteran journalists Mr. Brill and co-CEO Gordon Crovitz created in 2018 to combat misinformation in the news. HealthGuard, which is free for users globally through June, is specifically aimed at informing readers about health myths related to vaccines and COVID-19. It will cost $35 per year after that.

The HealthGuard Coronavirus Tracking Center has flagged nearly 400 websites for publishing misinformation about the coronavirus, including several top myths about COVID-19 vaccines:

  • The mRNA vaccines can alter human DNA.
  • Vaccines will use microchip surveillance technology.
  • COVID-19 vaccines cause infertility.
  • The vaccine developed by Oxford University will turn people into monkeys.
  • COVID-19 vaccines contain aborted human fetal tissue.

As a partner, this news organization will feature continuing coverage of COVID-19 vaccine misinformation, including articles and videos.

There will be other efforts this year. Google has launched a $3 million fund to back fact-checking organizations to counter vaccine misinformation, and social media platforms are monitoring posts that actively promote disinformation around vaccines.

The United States has distributed nearly 50 million vaccine doses, and states have administered more than 32 million of them, including 5.9 million second doses in the two-shot vaccines, according to the latest CDC update.

To reach herd immunity, about 75%-85% of Americans will need to receive a vaccine, Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, said in December 2020.

Vaccine skepticism has increased in recent years, which has led to a decline in vaccination rates and the highest annual number of measles cases in the United States in more than 25 years, according to the Pew Research Center. In 2019, the World Health Organization named vaccine hesitancy as 1 of 10 threats to global health.

With the COVID-19 vaccines in particular, people have voiced concerns about their safety and how well they work, given their accelerated development, according to Kaiser’s poll. They’re also worried about potential side effects, the perceived role of politics in the development process, and a lack of trust in government. Others don’t trust vaccines in general or believe they may contract COVID-19 from a vaccine, the Kaiser poll found, “suggesting that messages combating particular types of misinformation may be especially important for increasing vaccine confidence.”

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

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