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extacy
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A peer-reviewed clinical journal serving healthcare professionals working with the Department of Veterans Affairs, the Department of Defense, and the Public Health Service.
Clinician experience, life stressors drive HIV adherence, retention in new patients
A novel twist on the concept of “meeting people where they are” may hold the key to retaining new HIV patients, and even bringing the elusive goal of ending the AIDS epidemic a bit closer. While the concept commonly refers to community outreach and engagement, understanding patient experiences and expectations and personal life stressors in the actual clinic setting may improve overall outcomes, according to new research.
In fact,
“Medical science is not necessarily [at the forefront] of where we want to focus our efforts right now,” Emmanuel Guajardo, MD, lead study author and instructor of infectious diseases at Baylor College of Medicine, Houston, told this news organization.
Rather, “we need to focus on retention in care and adherence to medications. Doubling down on these efforts could really go a long way toward ending the HIV epidemic,” he said.
Study findings were published online Jan. 5, 2022, in AIDS and Behavior.
First time’s a charm
A total of 450 patients attending an HIV clinic in Houston were asked to complete a postvisit survey detailing their experience with the HIV clinician, as well as personal life stressors in the preceding 6 months. Study participants were predominantly non-Hispanic Black (54.2%) or Hispanic (30.7%) and mostly men who have sex with men (MSM), populations that mimic the patients seen at Dr. Guajardo’s clinic. Patients were given the option of survey completion while awaiting discharge, within 2 weeks at the clinic, or (as a last resort) by phone.
Overall scores were based on a composite of validated scales: patient experience scores were defined dichotomously (best experience, most positive experience vs. not the best experience), and life stressor events (death, relationship, economic) were assigned weighted scores based on life change impact (for example, death of a spouse received a score of 100 while moved/changed living location was assigned a score of 25).
“We found that patients who reported better initial experiences with their provider at the first visit were less likely to be lost to follow-up at 6 and 12 months,” explained Dr. Guajardo. “Having fewer life stressors at the first visit [was] also [protective].”
At 6 months, mean overall patient experience scores were 8.60 for those LTFU versus and 8.98 for those not LTFU (P = .011); corresponding mean scores at 12 months were 8.43 and 8.98 respectively (P = .001).
For the dichotomized scoring, patients reporting the best experience with the health care professional were significantly less likely to be LTFU at 6 months (adjusted odd ratio, 0.866; P = .038) and 12 months (aOR, 1.263; P = .029) versus those not reporting the best experience.
Mean life change scores appeared to portend patient drop-off; patients reporting more stressful life events were likelier to be LTFU at 6 months (mean life change score, 129 vs. 100 for those retained in care) and at 12 months (126 vs. 101).
Corresponding multivariate logistic regression models controlling for age, baseline CD4 cell count less than 200, and diagnosis of at least 3 months showed that patients with higher life stressor burdens were significantly more likely to be LTFU at both 6 months (aOR, 1.232, P = .037) and 12 months (aOR, 1.263, P = .029).
Approach matters
“The [study] really hits the nail on the head in terms of identifying a couple of these very salient issues that affect people’s care, especially concerning HIV,” Philip A. Chan, MD, infectious disease specialist and associate professor of medicine at Brown University, Providence, R.I, told this news organization.
“It highlights things that we see on the ground that can interfere with HIV care or [pre-exposure prophylaxis] care, just health care in general, certainly one’s relationship with the physician or provider, and also, you know, real-life stressors,” said Dr. Chan, who was not involved with the study.
Relationship building is especially important for historically underserved populations, a point that’s hardly lost on either Dr. Chan or Dr. Guajardo, who both pointed to higher levels of mistrust among certain patient populations because of their mistreatment by the health care system. The answer? Let the patient lead the initial discussion, allow them to feel comfortable and participate in their care in ways that are most beneficial to them.
“There’s so much miscommunication, misunderstanding, and stigma related to HIV out in the community. So, it’s important to really open the floor for whatever they want to talk about first, before I push any agenda on a new patient.” Dr. Guajardo said. Thereafter, he relies on open-ended questions such as ‘tell me about your sexual partners?’ or ‘what sort of sexual practices do you engage in?’
“At the end of the day, you just need someone dedicated, who can be respectful and listening and caring, and dedicate time to patients to help keep them in care, to listen, and to navigate our incredibly, incredibly complex health care system,” Dr. Chan added.
This study was partly supported by use of the facilities and resources of the Houston Veterans Affairs Center for Innovations in Quality, Effectiveness, and Safety and Harris Health System. Support for the study was also provided by the National Institute of Mental Health and the University of Texas MD Anderson Foundation Chair at Baylor College of Medicine. Dr. Guajardo and Dr. Chan disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
A novel twist on the concept of “meeting people where they are” may hold the key to retaining new HIV patients, and even bringing the elusive goal of ending the AIDS epidemic a bit closer. While the concept commonly refers to community outreach and engagement, understanding patient experiences and expectations and personal life stressors in the actual clinic setting may improve overall outcomes, according to new research.
In fact,
“Medical science is not necessarily [at the forefront] of where we want to focus our efforts right now,” Emmanuel Guajardo, MD, lead study author and instructor of infectious diseases at Baylor College of Medicine, Houston, told this news organization.
Rather, “we need to focus on retention in care and adherence to medications. Doubling down on these efforts could really go a long way toward ending the HIV epidemic,” he said.
Study findings were published online Jan. 5, 2022, in AIDS and Behavior.
First time’s a charm
A total of 450 patients attending an HIV clinic in Houston were asked to complete a postvisit survey detailing their experience with the HIV clinician, as well as personal life stressors in the preceding 6 months. Study participants were predominantly non-Hispanic Black (54.2%) or Hispanic (30.7%) and mostly men who have sex with men (MSM), populations that mimic the patients seen at Dr. Guajardo’s clinic. Patients were given the option of survey completion while awaiting discharge, within 2 weeks at the clinic, or (as a last resort) by phone.
Overall scores were based on a composite of validated scales: patient experience scores were defined dichotomously (best experience, most positive experience vs. not the best experience), and life stressor events (death, relationship, economic) were assigned weighted scores based on life change impact (for example, death of a spouse received a score of 100 while moved/changed living location was assigned a score of 25).
“We found that patients who reported better initial experiences with their provider at the first visit were less likely to be lost to follow-up at 6 and 12 months,” explained Dr. Guajardo. “Having fewer life stressors at the first visit [was] also [protective].”
At 6 months, mean overall patient experience scores were 8.60 for those LTFU versus and 8.98 for those not LTFU (P = .011); corresponding mean scores at 12 months were 8.43 and 8.98 respectively (P = .001).
For the dichotomized scoring, patients reporting the best experience with the health care professional were significantly less likely to be LTFU at 6 months (adjusted odd ratio, 0.866; P = .038) and 12 months (aOR, 1.263; P = .029) versus those not reporting the best experience.
Mean life change scores appeared to portend patient drop-off; patients reporting more stressful life events were likelier to be LTFU at 6 months (mean life change score, 129 vs. 100 for those retained in care) and at 12 months (126 vs. 101).
Corresponding multivariate logistic regression models controlling for age, baseline CD4 cell count less than 200, and diagnosis of at least 3 months showed that patients with higher life stressor burdens were significantly more likely to be LTFU at both 6 months (aOR, 1.232, P = .037) and 12 months (aOR, 1.263, P = .029).
Approach matters
“The [study] really hits the nail on the head in terms of identifying a couple of these very salient issues that affect people’s care, especially concerning HIV,” Philip A. Chan, MD, infectious disease specialist and associate professor of medicine at Brown University, Providence, R.I, told this news organization.
“It highlights things that we see on the ground that can interfere with HIV care or [pre-exposure prophylaxis] care, just health care in general, certainly one’s relationship with the physician or provider, and also, you know, real-life stressors,” said Dr. Chan, who was not involved with the study.
Relationship building is especially important for historically underserved populations, a point that’s hardly lost on either Dr. Chan or Dr. Guajardo, who both pointed to higher levels of mistrust among certain patient populations because of their mistreatment by the health care system. The answer? Let the patient lead the initial discussion, allow them to feel comfortable and participate in their care in ways that are most beneficial to them.
“There’s so much miscommunication, misunderstanding, and stigma related to HIV out in the community. So, it’s important to really open the floor for whatever they want to talk about first, before I push any agenda on a new patient.” Dr. Guajardo said. Thereafter, he relies on open-ended questions such as ‘tell me about your sexual partners?’ or ‘what sort of sexual practices do you engage in?’
“At the end of the day, you just need someone dedicated, who can be respectful and listening and caring, and dedicate time to patients to help keep them in care, to listen, and to navigate our incredibly, incredibly complex health care system,” Dr. Chan added.
This study was partly supported by use of the facilities and resources of the Houston Veterans Affairs Center for Innovations in Quality, Effectiveness, and Safety and Harris Health System. Support for the study was also provided by the National Institute of Mental Health and the University of Texas MD Anderson Foundation Chair at Baylor College of Medicine. Dr. Guajardo and Dr. Chan disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
A novel twist on the concept of “meeting people where they are” may hold the key to retaining new HIV patients, and even bringing the elusive goal of ending the AIDS epidemic a bit closer. While the concept commonly refers to community outreach and engagement, understanding patient experiences and expectations and personal life stressors in the actual clinic setting may improve overall outcomes, according to new research.
In fact,
“Medical science is not necessarily [at the forefront] of where we want to focus our efforts right now,” Emmanuel Guajardo, MD, lead study author and instructor of infectious diseases at Baylor College of Medicine, Houston, told this news organization.
Rather, “we need to focus on retention in care and adherence to medications. Doubling down on these efforts could really go a long way toward ending the HIV epidemic,” he said.
Study findings were published online Jan. 5, 2022, in AIDS and Behavior.
First time’s a charm
A total of 450 patients attending an HIV clinic in Houston were asked to complete a postvisit survey detailing their experience with the HIV clinician, as well as personal life stressors in the preceding 6 months. Study participants were predominantly non-Hispanic Black (54.2%) or Hispanic (30.7%) and mostly men who have sex with men (MSM), populations that mimic the patients seen at Dr. Guajardo’s clinic. Patients were given the option of survey completion while awaiting discharge, within 2 weeks at the clinic, or (as a last resort) by phone.
Overall scores were based on a composite of validated scales: patient experience scores were defined dichotomously (best experience, most positive experience vs. not the best experience), and life stressor events (death, relationship, economic) were assigned weighted scores based on life change impact (for example, death of a spouse received a score of 100 while moved/changed living location was assigned a score of 25).
“We found that patients who reported better initial experiences with their provider at the first visit were less likely to be lost to follow-up at 6 and 12 months,” explained Dr. Guajardo. “Having fewer life stressors at the first visit [was] also [protective].”
At 6 months, mean overall patient experience scores were 8.60 for those LTFU versus and 8.98 for those not LTFU (P = .011); corresponding mean scores at 12 months were 8.43 and 8.98 respectively (P = .001).
For the dichotomized scoring, patients reporting the best experience with the health care professional were significantly less likely to be LTFU at 6 months (adjusted odd ratio, 0.866; P = .038) and 12 months (aOR, 1.263; P = .029) versus those not reporting the best experience.
Mean life change scores appeared to portend patient drop-off; patients reporting more stressful life events were likelier to be LTFU at 6 months (mean life change score, 129 vs. 100 for those retained in care) and at 12 months (126 vs. 101).
Corresponding multivariate logistic regression models controlling for age, baseline CD4 cell count less than 200, and diagnosis of at least 3 months showed that patients with higher life stressor burdens were significantly more likely to be LTFU at both 6 months (aOR, 1.232, P = .037) and 12 months (aOR, 1.263, P = .029).
Approach matters
“The [study] really hits the nail on the head in terms of identifying a couple of these very salient issues that affect people’s care, especially concerning HIV,” Philip A. Chan, MD, infectious disease specialist and associate professor of medicine at Brown University, Providence, R.I, told this news organization.
“It highlights things that we see on the ground that can interfere with HIV care or [pre-exposure prophylaxis] care, just health care in general, certainly one’s relationship with the physician or provider, and also, you know, real-life stressors,” said Dr. Chan, who was not involved with the study.
Relationship building is especially important for historically underserved populations, a point that’s hardly lost on either Dr. Chan or Dr. Guajardo, who both pointed to higher levels of mistrust among certain patient populations because of their mistreatment by the health care system. The answer? Let the patient lead the initial discussion, allow them to feel comfortable and participate in their care in ways that are most beneficial to them.
“There’s so much miscommunication, misunderstanding, and stigma related to HIV out in the community. So, it’s important to really open the floor for whatever they want to talk about first, before I push any agenda on a new patient.” Dr. Guajardo said. Thereafter, he relies on open-ended questions such as ‘tell me about your sexual partners?’ or ‘what sort of sexual practices do you engage in?’
“At the end of the day, you just need someone dedicated, who can be respectful and listening and caring, and dedicate time to patients to help keep them in care, to listen, and to navigate our incredibly, incredibly complex health care system,” Dr. Chan added.
This study was partly supported by use of the facilities and resources of the Houston Veterans Affairs Center for Innovations in Quality, Effectiveness, and Safety and Harris Health System. Support for the study was also provided by the National Institute of Mental Health and the University of Texas MD Anderson Foundation Chair at Baylor College of Medicine. Dr. Guajardo and Dr. Chan disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM AIDS AND BEHAVIOR
Lifestyle changes can lead to remission, but not a cure, in type 2 diabetes
Whenever I get a new patient with type 2 diabetes, who is generally on metformin, one of the very first questions they ask me is, “Can I get off my medication?” Everybody, it seems, who gets diabetes wants to not have diabetes.
So, what does this really mean? What does this mean to me as a clinician? And what does this mean to my patients? The American Diabetes Association recently came out with a consensus statement that defines and interprets the definition of remission in people with type 2 diabetes. Basically, if the hemoglobin A1c is less than 6.5% without diabetes medications for at least 3 months, that’s considered remission.
There are other considerations, such as metabolic surgery, that can lead to remission. But again, such patients should be 3 months post surgery and at least 3 months off diabetes medication. As for a lifestyle intervention, the authors state that remission really happens within about 6 months.
That leads me to wonder: What is remission? Remission really means temporary recovery, so it doesn’t mean a cure. Now, I’m not against curing diabetes. In fact, I’m all for it. But when somebody gets diabetes – and honestly, it doesn’t matter whether it’s type 1 or type 2 – the first thing I think of, and I think the first thing that my patients are taught, is how important it is to have a healthy lifestyle. This healthy lifestyle isn’t just for people with diabetes; it largely means the healthy lifestyle that all of us should follow, one where we eat fewer simple carbs, less processed food, more vegetables, more lean proteins and meats – all of the things that we know we should do. And all of the things that keep us healthy. To some degree, I don’t think you can ever get “remission” from diabetes, because if having diabetes points an individual toward having a healthier lifestyle, I think that’s great.
I think people should exercise more. When it comes to treating diabetes, exercise is key. When you think about obesity, we want to help people who are overweight or obese lose weight as part of their treatment for diabetes. And that doesn’t go away, either.
So, no, people who are diagnosed with diabetes don’t really go into remission if they keep their same old habits and don’t lose weight and don’t exercise. But many people with diabetes can get off medication if they do those things.
However, it’s not true for everybody, and I don’t want people to get unrealistic expectations because I think there are probably about a thousand different subtypes of type 2 diabetes. And I’ve definitely seen people who are lean with type 2 diabetes who don’t respond as well to a lifestyle intervention, or people who are more insulin deficient, who also need medication.
I think it’s really important to frame the expectation that, if remission means going back to the way it was before, when they didn’t have to think about what they ate or whether or not they exercised, that’s not going to happen. I think diabetes should really be a wake-up call that people need to be healthier in terms of their lifestyle habits.
The issue of medication is really an individual one, and I think we need to help patients look for what’s best for the individual, what their targets are, what their goals are. But we also have to think that diabetes isn’t just about glucose.
So remission in terms of the ADA’s definition looks at glucose, but I look at more than glucose. You have to look at lipids and blood pressure. And, as I mentioned earlier, you have to look at whether or not a person has preexisting cardiovascular disease or has the presence of microvascular complications that need to be screened for and treated.
I actually think that, in some ways, the diagnosis of diabetes is helpful simply because it helps put people on a better path to health. I don’t want people to think that remission means that they can go back to unhealthy habits. I really encourage all people to live a healthier lifestyle, and if it leads to improvements in glucose levels and getting off medication, I think that’s wonderful and a worthy goal. But remember, health and meeting one’s targets remain key in the treatment of type 2 diabetes.
Dr. Peters is a professor in the department of clinical medicine at the University of Southern California, Los Angeles. She reported serving on the advisory board or speakers’ bureau of Medscape and several pharmaceutical companies, and has received research support from Dexcom, MannKind, and AstraZeneca. This perspective and an accompanying video first appeared on Medscape.com.
Whenever I get a new patient with type 2 diabetes, who is generally on metformin, one of the very first questions they ask me is, “Can I get off my medication?” Everybody, it seems, who gets diabetes wants to not have diabetes.
So, what does this really mean? What does this mean to me as a clinician? And what does this mean to my patients? The American Diabetes Association recently came out with a consensus statement that defines and interprets the definition of remission in people with type 2 diabetes. Basically, if the hemoglobin A1c is less than 6.5% without diabetes medications for at least 3 months, that’s considered remission.
There are other considerations, such as metabolic surgery, that can lead to remission. But again, such patients should be 3 months post surgery and at least 3 months off diabetes medication. As for a lifestyle intervention, the authors state that remission really happens within about 6 months.
That leads me to wonder: What is remission? Remission really means temporary recovery, so it doesn’t mean a cure. Now, I’m not against curing diabetes. In fact, I’m all for it. But when somebody gets diabetes – and honestly, it doesn’t matter whether it’s type 1 or type 2 – the first thing I think of, and I think the first thing that my patients are taught, is how important it is to have a healthy lifestyle. This healthy lifestyle isn’t just for people with diabetes; it largely means the healthy lifestyle that all of us should follow, one where we eat fewer simple carbs, less processed food, more vegetables, more lean proteins and meats – all of the things that we know we should do. And all of the things that keep us healthy. To some degree, I don’t think you can ever get “remission” from diabetes, because if having diabetes points an individual toward having a healthier lifestyle, I think that’s great.
I think people should exercise more. When it comes to treating diabetes, exercise is key. When you think about obesity, we want to help people who are overweight or obese lose weight as part of their treatment for diabetes. And that doesn’t go away, either.
So, no, people who are diagnosed with diabetes don’t really go into remission if they keep their same old habits and don’t lose weight and don’t exercise. But many people with diabetes can get off medication if they do those things.
However, it’s not true for everybody, and I don’t want people to get unrealistic expectations because I think there are probably about a thousand different subtypes of type 2 diabetes. And I’ve definitely seen people who are lean with type 2 diabetes who don’t respond as well to a lifestyle intervention, or people who are more insulin deficient, who also need medication.
I think it’s really important to frame the expectation that, if remission means going back to the way it was before, when they didn’t have to think about what they ate or whether or not they exercised, that’s not going to happen. I think diabetes should really be a wake-up call that people need to be healthier in terms of their lifestyle habits.
The issue of medication is really an individual one, and I think we need to help patients look for what’s best for the individual, what their targets are, what their goals are. But we also have to think that diabetes isn’t just about glucose.
So remission in terms of the ADA’s definition looks at glucose, but I look at more than glucose. You have to look at lipids and blood pressure. And, as I mentioned earlier, you have to look at whether or not a person has preexisting cardiovascular disease or has the presence of microvascular complications that need to be screened for and treated.
I actually think that, in some ways, the diagnosis of diabetes is helpful simply because it helps put people on a better path to health. I don’t want people to think that remission means that they can go back to unhealthy habits. I really encourage all people to live a healthier lifestyle, and if it leads to improvements in glucose levels and getting off medication, I think that’s wonderful and a worthy goal. But remember, health and meeting one’s targets remain key in the treatment of type 2 diabetes.
Dr. Peters is a professor in the department of clinical medicine at the University of Southern California, Los Angeles. She reported serving on the advisory board or speakers’ bureau of Medscape and several pharmaceutical companies, and has received research support from Dexcom, MannKind, and AstraZeneca. This perspective and an accompanying video first appeared on Medscape.com.
Whenever I get a new patient with type 2 diabetes, who is generally on metformin, one of the very first questions they ask me is, “Can I get off my medication?” Everybody, it seems, who gets diabetes wants to not have diabetes.
So, what does this really mean? What does this mean to me as a clinician? And what does this mean to my patients? The American Diabetes Association recently came out with a consensus statement that defines and interprets the definition of remission in people with type 2 diabetes. Basically, if the hemoglobin A1c is less than 6.5% without diabetes medications for at least 3 months, that’s considered remission.
There are other considerations, such as metabolic surgery, that can lead to remission. But again, such patients should be 3 months post surgery and at least 3 months off diabetes medication. As for a lifestyle intervention, the authors state that remission really happens within about 6 months.
That leads me to wonder: What is remission? Remission really means temporary recovery, so it doesn’t mean a cure. Now, I’m not against curing diabetes. In fact, I’m all for it. But when somebody gets diabetes – and honestly, it doesn’t matter whether it’s type 1 or type 2 – the first thing I think of, and I think the first thing that my patients are taught, is how important it is to have a healthy lifestyle. This healthy lifestyle isn’t just for people with diabetes; it largely means the healthy lifestyle that all of us should follow, one where we eat fewer simple carbs, less processed food, more vegetables, more lean proteins and meats – all of the things that we know we should do. And all of the things that keep us healthy. To some degree, I don’t think you can ever get “remission” from diabetes, because if having diabetes points an individual toward having a healthier lifestyle, I think that’s great.
I think people should exercise more. When it comes to treating diabetes, exercise is key. When you think about obesity, we want to help people who are overweight or obese lose weight as part of their treatment for diabetes. And that doesn’t go away, either.
So, no, people who are diagnosed with diabetes don’t really go into remission if they keep their same old habits and don’t lose weight and don’t exercise. But many people with diabetes can get off medication if they do those things.
However, it’s not true for everybody, and I don’t want people to get unrealistic expectations because I think there are probably about a thousand different subtypes of type 2 diabetes. And I’ve definitely seen people who are lean with type 2 diabetes who don’t respond as well to a lifestyle intervention, or people who are more insulin deficient, who also need medication.
I think it’s really important to frame the expectation that, if remission means going back to the way it was before, when they didn’t have to think about what they ate or whether or not they exercised, that’s not going to happen. I think diabetes should really be a wake-up call that people need to be healthier in terms of their lifestyle habits.
The issue of medication is really an individual one, and I think we need to help patients look for what’s best for the individual, what their targets are, what their goals are. But we also have to think that diabetes isn’t just about glucose.
So remission in terms of the ADA’s definition looks at glucose, but I look at more than glucose. You have to look at lipids and blood pressure. And, as I mentioned earlier, you have to look at whether or not a person has preexisting cardiovascular disease or has the presence of microvascular complications that need to be screened for and treated.
I actually think that, in some ways, the diagnosis of diabetes is helpful simply because it helps put people on a better path to health. I don’t want people to think that remission means that they can go back to unhealthy habits. I really encourage all people to live a healthier lifestyle, and if it leads to improvements in glucose levels and getting off medication, I think that’s wonderful and a worthy goal. But remember, health and meeting one’s targets remain key in the treatment of type 2 diabetes.
Dr. Peters is a professor in the department of clinical medicine at the University of Southern California, Los Angeles. She reported serving on the advisory board or speakers’ bureau of Medscape and several pharmaceutical companies, and has received research support from Dexcom, MannKind, and AstraZeneca. This perspective and an accompanying video first appeared on Medscape.com.
U.S. cancer deaths continue to fall, especially lung cancer
There has been an overall decline of 32% in cancer deaths as of 2019, or approximately 3.5 million cancer deaths averted, the report noted.
“This success is largely because of reductions in smoking that resulted in downstream declines in lung and other smoking-related cancers,” lead author Rebecca L. Siegel of the ACS, and colleagues, noted in the latest edition of the society’s annual report on cancer rates and trends.
The paper was published online Jan. 12 in CA: A Cancer Journal for Clinicians.
In particular, there has been a fall in both the incidence of and mortality from lung cancer, largely due to successful efforts to get people to quit smoking, but also from earlier diagnosis at a stage when the disease is far more amenable to treatment, noted the authors.
For example, the incidence of lung cancer declined by almost 3% per year in men between the years 2009 and 2018 and by 1% a year in women. Currently, the historically large gender gap in lung cancer incidence is disappearing such that in 2018, lung cancer rates were 24% higher in men than they were in women, and rates in women were actually higher in some younger age groups than they were in men.
Moreover, 28% of lung cancers detected in 2018 were found at a localized stage of disease compared with 17% in 2004.
Patients diagnosed with lung cancer are also living longer, with almost one-third of lung cancer patients still alive 3 years after their diagnosis compared with 21% a decade ago.
However, lung cancer is still the biggest contributor to cancer-related mortality overall, at a death toll of 350 per day – more than breast, prostate, and pancreatic cancer combined, the authors wrote.
This is 2.5 times higher than the death rate from colorectal cancer (CRC), the second leading cause of cancer death in the United States, they added.
Nevertheless, the decrease in lung cancer mortality accelerated from 3.1% per year between 2010 and 2014 to 5.4% per year during 2015 to 2019 in men and from 1.8% to 4.3% in women. “Overall, the lung cancer death rate has dropped by 56% from 1990 to 2019 in men and by 32% from 2002 to 2019 in women,” Ms. Siegel and colleagues emphasized.
Overall, the ACS projects there will be over 1.9 million new cancer cases and over 600,000 cancer deaths across the United States in 2022.
Patterns are changing
With prostate cancer now accounting for some 27% of all cancer diagnoses in men, recent trends in the incidence of prostate cancer are somewhat worrisome, the authors wrote. While the incidence for local-stage disease remained stable from 2014 through to 2018, the incidence of advanced-stage disease has increased by 6% a year since 2011. “Consequently, the proportion of distant-stage diagnoses has more than doubled,” the authors noted, “from a low of 3.9% in 2007 to 8.2% in 2018.”
The incidence of breast cancer among women has been slowly increasing by 0.5% per year since about the mid-2000s. This increase is due at least in part to declines in fertility and increases in body weight among women, the authors suggested. Declines in breast cancer mortality have slowed in recent years, dropping from 1% per year from 2013 to 2019 from 2%-3% per year seen during the 1990s and the early 2000s.
As for CRC, incidence patterns are similar by sex but differ by age. For example, incidence rates of CRC declined by about 2% per year between 2014 and 2018 in individuals 50 years and older, but they increased by 1.5% per year in adults under the age of 50. Overall, however, mortality from CRC decreased by about 2% per year between 2010 and 2019, although this trend again masks increasing mortality from CRC among younger adults, where death rates rose by 1.2% per year from 2005 through 2019 in patients under the age of 50.
The third leading cause of death in men and women combined is pancreatic cancer. Here again, mortality rates slowly increased in men between 2000 and 2013 but have remained relatively stable in women.
Between 2010 and 2019, cancers of the tongue, tonsils, and oropharynx caused by human papilloma virus (HPV) increased by about 2% per year in men and by 1% per year in women.
Death from cervical cancer – despite its being one of the most preventable cancers overall – is still the second leading cause of cancer death in women between 20 and 39 years of age. “Most of these women have never been screened so this is low-hanging fruit easily addressed by increasing access to screening and [HPV] vaccination among underserved women,” Ms. Siegel said in a statement.
On the other hand, mortality from liver cancer – having increased rapidly over the past number of decades – appears to have stabilized in more recent years.
Survival at 5 years
For all cancers combined, survival at 5 years between the mid-1970s and 2011 through 2017 increased from 50% to 68% for White patients and by 39% to 63% for Black patients. “For all stages combined, survival is highest for prostate cancer (98%), melanoma of the skin (93%) and female breast cancer (90%),” the authors pointed out.
In contrast, survival at 5 years is lowest, at 11% for pancreatic cancer, 20% for cancers of the liver and esophagus, and 22% for lung cancer.
Indeed, for most of the common cancers, cancer survival has improved since the mid-1970s with the exception or uterine and cervical cancer, the latter because there have been few advancements in treatment.
Even among the more rare blood and lymphoid malignancies, improvements in treatment strategies, including the use of targeted therapies, have resulted in major survival gains from around 20% in the mid-1970s for chronic myeloid leukemia (CML) patients to over 70% for CML patients diagnosed between 2011 and 2017.
Similarly, the discovery and use of immunotherapy has doubled 5-year survival rates to 30% for patients with metastatic melanoma from 15% in 2004. On the other hand, racial disparities in survival odds continue to persist. For every cancer type except for cancer of the pancreas and kidney, survival rates were lower for Black patients than for White patients, the researchers pointed out.
“Black individuals also have lower stage-specific survival for most cancer types,” the report authors noted. Indeed, after adjustment for sex, age, and stage at diagnosis, the risk of death is 33% higher in Black patients than White patients and 51% higher in American Indian/Alaska Natives compared to White patients.
That said, the overall incidence of cancer is still highest among White individuals, in part because of high rates of breast cancer in White women, which may in part reflect overdiagnosis of breast cancer in this patient population, as the authors suggested.
“However, Black women have the highest cancer mortality rates – 12% higher than White women,” they observed. Even more striking, Black women have a 4% lower incidence of breast cancer than White women but a 41% higher mortality risk from it.
As for pediatric and adolescent cancers, incidence rates may be increasing slightly among both age groups, but dramatic reductions in death by 71% among children and by 61% among adolescents from the mid-70s until now continue as a singular success story in the treatment of cancer overall.
All the authors are employed by the ACS.
A version of this article first appeared on Medscape.com.
There has been an overall decline of 32% in cancer deaths as of 2019, or approximately 3.5 million cancer deaths averted, the report noted.
“This success is largely because of reductions in smoking that resulted in downstream declines in lung and other smoking-related cancers,” lead author Rebecca L. Siegel of the ACS, and colleagues, noted in the latest edition of the society’s annual report on cancer rates and trends.
The paper was published online Jan. 12 in CA: A Cancer Journal for Clinicians.
In particular, there has been a fall in both the incidence of and mortality from lung cancer, largely due to successful efforts to get people to quit smoking, but also from earlier diagnosis at a stage when the disease is far more amenable to treatment, noted the authors.
For example, the incidence of lung cancer declined by almost 3% per year in men between the years 2009 and 2018 and by 1% a year in women. Currently, the historically large gender gap in lung cancer incidence is disappearing such that in 2018, lung cancer rates were 24% higher in men than they were in women, and rates in women were actually higher in some younger age groups than they were in men.
Moreover, 28% of lung cancers detected in 2018 were found at a localized stage of disease compared with 17% in 2004.
Patients diagnosed with lung cancer are also living longer, with almost one-third of lung cancer patients still alive 3 years after their diagnosis compared with 21% a decade ago.
However, lung cancer is still the biggest contributor to cancer-related mortality overall, at a death toll of 350 per day – more than breast, prostate, and pancreatic cancer combined, the authors wrote.
This is 2.5 times higher than the death rate from colorectal cancer (CRC), the second leading cause of cancer death in the United States, they added.
Nevertheless, the decrease in lung cancer mortality accelerated from 3.1% per year between 2010 and 2014 to 5.4% per year during 2015 to 2019 in men and from 1.8% to 4.3% in women. “Overall, the lung cancer death rate has dropped by 56% from 1990 to 2019 in men and by 32% from 2002 to 2019 in women,” Ms. Siegel and colleagues emphasized.
Overall, the ACS projects there will be over 1.9 million new cancer cases and over 600,000 cancer deaths across the United States in 2022.
Patterns are changing
With prostate cancer now accounting for some 27% of all cancer diagnoses in men, recent trends in the incidence of prostate cancer are somewhat worrisome, the authors wrote. While the incidence for local-stage disease remained stable from 2014 through to 2018, the incidence of advanced-stage disease has increased by 6% a year since 2011. “Consequently, the proportion of distant-stage diagnoses has more than doubled,” the authors noted, “from a low of 3.9% in 2007 to 8.2% in 2018.”
The incidence of breast cancer among women has been slowly increasing by 0.5% per year since about the mid-2000s. This increase is due at least in part to declines in fertility and increases in body weight among women, the authors suggested. Declines in breast cancer mortality have slowed in recent years, dropping from 1% per year from 2013 to 2019 from 2%-3% per year seen during the 1990s and the early 2000s.
As for CRC, incidence patterns are similar by sex but differ by age. For example, incidence rates of CRC declined by about 2% per year between 2014 and 2018 in individuals 50 years and older, but they increased by 1.5% per year in adults under the age of 50. Overall, however, mortality from CRC decreased by about 2% per year between 2010 and 2019, although this trend again masks increasing mortality from CRC among younger adults, where death rates rose by 1.2% per year from 2005 through 2019 in patients under the age of 50.
The third leading cause of death in men and women combined is pancreatic cancer. Here again, mortality rates slowly increased in men between 2000 and 2013 but have remained relatively stable in women.
Between 2010 and 2019, cancers of the tongue, tonsils, and oropharynx caused by human papilloma virus (HPV) increased by about 2% per year in men and by 1% per year in women.
Death from cervical cancer – despite its being one of the most preventable cancers overall – is still the second leading cause of cancer death in women between 20 and 39 years of age. “Most of these women have never been screened so this is low-hanging fruit easily addressed by increasing access to screening and [HPV] vaccination among underserved women,” Ms. Siegel said in a statement.
On the other hand, mortality from liver cancer – having increased rapidly over the past number of decades – appears to have stabilized in more recent years.
Survival at 5 years
For all cancers combined, survival at 5 years between the mid-1970s and 2011 through 2017 increased from 50% to 68% for White patients and by 39% to 63% for Black patients. “For all stages combined, survival is highest for prostate cancer (98%), melanoma of the skin (93%) and female breast cancer (90%),” the authors pointed out.
In contrast, survival at 5 years is lowest, at 11% for pancreatic cancer, 20% for cancers of the liver and esophagus, and 22% for lung cancer.
Indeed, for most of the common cancers, cancer survival has improved since the mid-1970s with the exception or uterine and cervical cancer, the latter because there have been few advancements in treatment.
Even among the more rare blood and lymphoid malignancies, improvements in treatment strategies, including the use of targeted therapies, have resulted in major survival gains from around 20% in the mid-1970s for chronic myeloid leukemia (CML) patients to over 70% for CML patients diagnosed between 2011 and 2017.
Similarly, the discovery and use of immunotherapy has doubled 5-year survival rates to 30% for patients with metastatic melanoma from 15% in 2004. On the other hand, racial disparities in survival odds continue to persist. For every cancer type except for cancer of the pancreas and kidney, survival rates were lower for Black patients than for White patients, the researchers pointed out.
“Black individuals also have lower stage-specific survival for most cancer types,” the report authors noted. Indeed, after adjustment for sex, age, and stage at diagnosis, the risk of death is 33% higher in Black patients than White patients and 51% higher in American Indian/Alaska Natives compared to White patients.
That said, the overall incidence of cancer is still highest among White individuals, in part because of high rates of breast cancer in White women, which may in part reflect overdiagnosis of breast cancer in this patient population, as the authors suggested.
“However, Black women have the highest cancer mortality rates – 12% higher than White women,” they observed. Even more striking, Black women have a 4% lower incidence of breast cancer than White women but a 41% higher mortality risk from it.
As for pediatric and adolescent cancers, incidence rates may be increasing slightly among both age groups, but dramatic reductions in death by 71% among children and by 61% among adolescents from the mid-70s until now continue as a singular success story in the treatment of cancer overall.
All the authors are employed by the ACS.
A version of this article first appeared on Medscape.com.
There has been an overall decline of 32% in cancer deaths as of 2019, or approximately 3.5 million cancer deaths averted, the report noted.
“This success is largely because of reductions in smoking that resulted in downstream declines in lung and other smoking-related cancers,” lead author Rebecca L. Siegel of the ACS, and colleagues, noted in the latest edition of the society’s annual report on cancer rates and trends.
The paper was published online Jan. 12 in CA: A Cancer Journal for Clinicians.
In particular, there has been a fall in both the incidence of and mortality from lung cancer, largely due to successful efforts to get people to quit smoking, but also from earlier diagnosis at a stage when the disease is far more amenable to treatment, noted the authors.
For example, the incidence of lung cancer declined by almost 3% per year in men between the years 2009 and 2018 and by 1% a year in women. Currently, the historically large gender gap in lung cancer incidence is disappearing such that in 2018, lung cancer rates were 24% higher in men than they were in women, and rates in women were actually higher in some younger age groups than they were in men.
Moreover, 28% of lung cancers detected in 2018 were found at a localized stage of disease compared with 17% in 2004.
Patients diagnosed with lung cancer are also living longer, with almost one-third of lung cancer patients still alive 3 years after their diagnosis compared with 21% a decade ago.
However, lung cancer is still the biggest contributor to cancer-related mortality overall, at a death toll of 350 per day – more than breast, prostate, and pancreatic cancer combined, the authors wrote.
This is 2.5 times higher than the death rate from colorectal cancer (CRC), the second leading cause of cancer death in the United States, they added.
Nevertheless, the decrease in lung cancer mortality accelerated from 3.1% per year between 2010 and 2014 to 5.4% per year during 2015 to 2019 in men and from 1.8% to 4.3% in women. “Overall, the lung cancer death rate has dropped by 56% from 1990 to 2019 in men and by 32% from 2002 to 2019 in women,” Ms. Siegel and colleagues emphasized.
Overall, the ACS projects there will be over 1.9 million new cancer cases and over 600,000 cancer deaths across the United States in 2022.
Patterns are changing
With prostate cancer now accounting for some 27% of all cancer diagnoses in men, recent trends in the incidence of prostate cancer are somewhat worrisome, the authors wrote. While the incidence for local-stage disease remained stable from 2014 through to 2018, the incidence of advanced-stage disease has increased by 6% a year since 2011. “Consequently, the proportion of distant-stage diagnoses has more than doubled,” the authors noted, “from a low of 3.9% in 2007 to 8.2% in 2018.”
The incidence of breast cancer among women has been slowly increasing by 0.5% per year since about the mid-2000s. This increase is due at least in part to declines in fertility and increases in body weight among women, the authors suggested. Declines in breast cancer mortality have slowed in recent years, dropping from 1% per year from 2013 to 2019 from 2%-3% per year seen during the 1990s and the early 2000s.
As for CRC, incidence patterns are similar by sex but differ by age. For example, incidence rates of CRC declined by about 2% per year between 2014 and 2018 in individuals 50 years and older, but they increased by 1.5% per year in adults under the age of 50. Overall, however, mortality from CRC decreased by about 2% per year between 2010 and 2019, although this trend again masks increasing mortality from CRC among younger adults, where death rates rose by 1.2% per year from 2005 through 2019 in patients under the age of 50.
The third leading cause of death in men and women combined is pancreatic cancer. Here again, mortality rates slowly increased in men between 2000 and 2013 but have remained relatively stable in women.
Between 2010 and 2019, cancers of the tongue, tonsils, and oropharynx caused by human papilloma virus (HPV) increased by about 2% per year in men and by 1% per year in women.
Death from cervical cancer – despite its being one of the most preventable cancers overall – is still the second leading cause of cancer death in women between 20 and 39 years of age. “Most of these women have never been screened so this is low-hanging fruit easily addressed by increasing access to screening and [HPV] vaccination among underserved women,” Ms. Siegel said in a statement.
On the other hand, mortality from liver cancer – having increased rapidly over the past number of decades – appears to have stabilized in more recent years.
Survival at 5 years
For all cancers combined, survival at 5 years between the mid-1970s and 2011 through 2017 increased from 50% to 68% for White patients and by 39% to 63% for Black patients. “For all stages combined, survival is highest for prostate cancer (98%), melanoma of the skin (93%) and female breast cancer (90%),” the authors pointed out.
In contrast, survival at 5 years is lowest, at 11% for pancreatic cancer, 20% for cancers of the liver and esophagus, and 22% for lung cancer.
Indeed, for most of the common cancers, cancer survival has improved since the mid-1970s with the exception or uterine and cervical cancer, the latter because there have been few advancements in treatment.
Even among the more rare blood and lymphoid malignancies, improvements in treatment strategies, including the use of targeted therapies, have resulted in major survival gains from around 20% in the mid-1970s for chronic myeloid leukemia (CML) patients to over 70% for CML patients diagnosed between 2011 and 2017.
Similarly, the discovery and use of immunotherapy has doubled 5-year survival rates to 30% for patients with metastatic melanoma from 15% in 2004. On the other hand, racial disparities in survival odds continue to persist. For every cancer type except for cancer of the pancreas and kidney, survival rates were lower for Black patients than for White patients, the researchers pointed out.
“Black individuals also have lower stage-specific survival for most cancer types,” the report authors noted. Indeed, after adjustment for sex, age, and stage at diagnosis, the risk of death is 33% higher in Black patients than White patients and 51% higher in American Indian/Alaska Natives compared to White patients.
That said, the overall incidence of cancer is still highest among White individuals, in part because of high rates of breast cancer in White women, which may in part reflect overdiagnosis of breast cancer in this patient population, as the authors suggested.
“However, Black women have the highest cancer mortality rates – 12% higher than White women,” they observed. Even more striking, Black women have a 4% lower incidence of breast cancer than White women but a 41% higher mortality risk from it.
As for pediatric and adolescent cancers, incidence rates may be increasing slightly among both age groups, but dramatic reductions in death by 71% among children and by 61% among adolescents from the mid-70s until now continue as a singular success story in the treatment of cancer overall.
All the authors are employed by the ACS.
A version of this article first appeared on Medscape.com.
FROM CA: A CANCER JOURNAL FOR CLINICIANS
What does a pig-to-human heart transplant mean for medicine?
Scientific achievements usually raise big new questions, and the remarkable surgery that took place on Jan. 7, when Maryland resident David Bennett was transplanted with a genetically modified heart from a pig, has been no different.
The 57-year-old with end-stage heart failure had been repeatedly turned down for a standard transplant and was judged a poor candidate for a ventricular assist device. Now his new heart is beating soundly and apparently accepted by his immune system as Mr. Bennett, his physicians at the University of Maryland where the procedure took place, and indeed the world set out on a journey with far more unknowns than knowns.
“I think even just a couple of years ago, people felt that xenotransplantation for the heart and other organs was still a long way off. And it seems like it’s started to move very quickly,” Larry A. Allen, MD, University of Colorado, Aurora, said in an interview.
Demand for donor hearts far outstrips supply, and despite advances in the development of ventricular assist pumps and artificial hearts, “there are still significant limitations to them in terms of clotting, stroke, and infection. We’ve seen the use of those devices plateau,” Dr. Allen said. “So, the concept of a nonhuman source of organs is exciting and very much in need, if people can get it to work.”
“I really credit the surgeons at the University of Maryland for courageous clinical work and a brilliant scientific innovation,” Clyde W. Yancy, MD, MSc, Northwestern University, Chicago, said in an interview. “But it’s always in the implementation that we have to hold our breath.” Heart xenotransplantation is an old idea that “has never before been successful,” he said. And standard heart transplantation has set a high bar, with a 1-year survival of about 90% and low 1-year risk for rejection. Whether the new procedure can meet that standard is unknown, as is its potential for complications, such as chronic rejection or cancers due to long-term immunosuppression. Those are “major questions requiring more time and careful follow-up.”
‘Still a nascent technology’
“This is an exciting and courageous step forward in heart transplantation, and kudos to the team at the University of Maryland,” said Mandeep R. Mehra, MD, Brigham and Woman’s Hospital, Boston. But “there are many challenges here.”
The procedure’s 10 gene modifications were reportedly aimed at preventing hyperacute rejection of the heart and its excessive growth after transplantation, and making the organ less immunogenic, Dr. Mehra said in an interview. But even if those goals are met, could the same changes potentially impede the heart’s adaptation to human physiology, such as during ambulation or stress?
That kind of adaptation may become important. For example, Dr. Mehra observed, normally a pig heart “provides flow in a four-footed configuration, and pig temperature is inherently higher than humans by several degrees, so it will be functioning in a relatively hypothermic environment.”
Transplantation remains the gold standard for patients with advanced heart failure despite modern medical and device therapy, Dr. Allen agreed. But “if we can raise pig hearts that provide the organ, and it can be implanted with a surgery that’s been done for 50 years, and rejection can be managed with gene editing and tailored immunosuppression, then it’s not hard to think about this very rapidly replacing a lot of what we do in the advanced heart failure and transplantation world.”
Certainly, it would be a major advance if the gene editing technique successfully improves the heart’s immunologic compatibility, Dr. Yancy noted. But do we have enough genomic knowledge to select gene deletions and insertions in the safest way for a successful outcome? “We have to appreciate that this is still a nascent technology, and we should be careful that there might be consequences that we haven’t anticipated.”
For example, he said, the xenotransplantation and gene-modifying techniques should be explored in a range of patients, including older and younger people, women and men, and people of different ethnicities and races.
“There may be some differences based on ancestry, based on gender, based on aging, that will influence the way in which these engineered donor hearts are experienced clinically,” Dr. Yancy said.
The xenotransplantation technique’s potential impact on health equity should also be considered, as it “almost assuredly will be a very expensive technology that will be utilized in a very select population,” he noted. “We need to have a really wide lens to think about all of the potential ramifications.”
‘This field needs to evolve’
Dr. Mehra also flagged the procedure’s potential cost should it become mainstream. Perhaps that would promote dialogue on how to primarily use it “after legitimately exhausting all available options, such as total artificial heart support.”
It might also teach the field to take greater advantage of the many donated hearts discarded as suboptimal. “The general usage rate for offered organs is around a third,” despite opportunities to expand use of those that are “less than perfect,” Dr. Mehra said. “I think that the field will grow with the community focusing on reduced discards of current available heart organs, and not necessarily grow because of the availability of ‘xeno-organs.’ ”
“This field needs to evolve because we’re actively transplanting patients today. But in my mind, the real future is to have such a sufficient understanding of the biology of left ventricular dysfunction that transplantation is a rare event,” Dr. Yancy proposed.
“I’m not certain that heart transplantation per se is the endgame. I think the avoidance of transplantation is the real endgame,” he said. “This may be controversial, but my vision of the future is not one where we have a supply of animals that we can use for transplantation. My vision of the future is that heart transplantation becomes obsolete.”
A version of this article first appeared on Medscape.com.
Scientific achievements usually raise big new questions, and the remarkable surgery that took place on Jan. 7, when Maryland resident David Bennett was transplanted with a genetically modified heart from a pig, has been no different.
The 57-year-old with end-stage heart failure had been repeatedly turned down for a standard transplant and was judged a poor candidate for a ventricular assist device. Now his new heart is beating soundly and apparently accepted by his immune system as Mr. Bennett, his physicians at the University of Maryland where the procedure took place, and indeed the world set out on a journey with far more unknowns than knowns.
“I think even just a couple of years ago, people felt that xenotransplantation for the heart and other organs was still a long way off. And it seems like it’s started to move very quickly,” Larry A. Allen, MD, University of Colorado, Aurora, said in an interview.
Demand for donor hearts far outstrips supply, and despite advances in the development of ventricular assist pumps and artificial hearts, “there are still significant limitations to them in terms of clotting, stroke, and infection. We’ve seen the use of those devices plateau,” Dr. Allen said. “So, the concept of a nonhuman source of organs is exciting and very much in need, if people can get it to work.”
“I really credit the surgeons at the University of Maryland for courageous clinical work and a brilliant scientific innovation,” Clyde W. Yancy, MD, MSc, Northwestern University, Chicago, said in an interview. “But it’s always in the implementation that we have to hold our breath.” Heart xenotransplantation is an old idea that “has never before been successful,” he said. And standard heart transplantation has set a high bar, with a 1-year survival of about 90% and low 1-year risk for rejection. Whether the new procedure can meet that standard is unknown, as is its potential for complications, such as chronic rejection or cancers due to long-term immunosuppression. Those are “major questions requiring more time and careful follow-up.”
‘Still a nascent technology’
“This is an exciting and courageous step forward in heart transplantation, and kudos to the team at the University of Maryland,” said Mandeep R. Mehra, MD, Brigham and Woman’s Hospital, Boston. But “there are many challenges here.”
The procedure’s 10 gene modifications were reportedly aimed at preventing hyperacute rejection of the heart and its excessive growth after transplantation, and making the organ less immunogenic, Dr. Mehra said in an interview. But even if those goals are met, could the same changes potentially impede the heart’s adaptation to human physiology, such as during ambulation or stress?
That kind of adaptation may become important. For example, Dr. Mehra observed, normally a pig heart “provides flow in a four-footed configuration, and pig temperature is inherently higher than humans by several degrees, so it will be functioning in a relatively hypothermic environment.”
Transplantation remains the gold standard for patients with advanced heart failure despite modern medical and device therapy, Dr. Allen agreed. But “if we can raise pig hearts that provide the organ, and it can be implanted with a surgery that’s been done for 50 years, and rejection can be managed with gene editing and tailored immunosuppression, then it’s not hard to think about this very rapidly replacing a lot of what we do in the advanced heart failure and transplantation world.”
Certainly, it would be a major advance if the gene editing technique successfully improves the heart’s immunologic compatibility, Dr. Yancy noted. But do we have enough genomic knowledge to select gene deletions and insertions in the safest way for a successful outcome? “We have to appreciate that this is still a nascent technology, and we should be careful that there might be consequences that we haven’t anticipated.”
For example, he said, the xenotransplantation and gene-modifying techniques should be explored in a range of patients, including older and younger people, women and men, and people of different ethnicities and races.
“There may be some differences based on ancestry, based on gender, based on aging, that will influence the way in which these engineered donor hearts are experienced clinically,” Dr. Yancy said.
The xenotransplantation technique’s potential impact on health equity should also be considered, as it “almost assuredly will be a very expensive technology that will be utilized in a very select population,” he noted. “We need to have a really wide lens to think about all of the potential ramifications.”
‘This field needs to evolve’
Dr. Mehra also flagged the procedure’s potential cost should it become mainstream. Perhaps that would promote dialogue on how to primarily use it “after legitimately exhausting all available options, such as total artificial heart support.”
It might also teach the field to take greater advantage of the many donated hearts discarded as suboptimal. “The general usage rate for offered organs is around a third,” despite opportunities to expand use of those that are “less than perfect,” Dr. Mehra said. “I think that the field will grow with the community focusing on reduced discards of current available heart organs, and not necessarily grow because of the availability of ‘xeno-organs.’ ”
“This field needs to evolve because we’re actively transplanting patients today. But in my mind, the real future is to have such a sufficient understanding of the biology of left ventricular dysfunction that transplantation is a rare event,” Dr. Yancy proposed.
“I’m not certain that heart transplantation per se is the endgame. I think the avoidance of transplantation is the real endgame,” he said. “This may be controversial, but my vision of the future is not one where we have a supply of animals that we can use for transplantation. My vision of the future is that heart transplantation becomes obsolete.”
A version of this article first appeared on Medscape.com.
Scientific achievements usually raise big new questions, and the remarkable surgery that took place on Jan. 7, when Maryland resident David Bennett was transplanted with a genetically modified heart from a pig, has been no different.
The 57-year-old with end-stage heart failure had been repeatedly turned down for a standard transplant and was judged a poor candidate for a ventricular assist device. Now his new heart is beating soundly and apparently accepted by his immune system as Mr. Bennett, his physicians at the University of Maryland where the procedure took place, and indeed the world set out on a journey with far more unknowns than knowns.
“I think even just a couple of years ago, people felt that xenotransplantation for the heart and other organs was still a long way off. And it seems like it’s started to move very quickly,” Larry A. Allen, MD, University of Colorado, Aurora, said in an interview.
Demand for donor hearts far outstrips supply, and despite advances in the development of ventricular assist pumps and artificial hearts, “there are still significant limitations to them in terms of clotting, stroke, and infection. We’ve seen the use of those devices plateau,” Dr. Allen said. “So, the concept of a nonhuman source of organs is exciting and very much in need, if people can get it to work.”
“I really credit the surgeons at the University of Maryland for courageous clinical work and a brilliant scientific innovation,” Clyde W. Yancy, MD, MSc, Northwestern University, Chicago, said in an interview. “But it’s always in the implementation that we have to hold our breath.” Heart xenotransplantation is an old idea that “has never before been successful,” he said. And standard heart transplantation has set a high bar, with a 1-year survival of about 90% and low 1-year risk for rejection. Whether the new procedure can meet that standard is unknown, as is its potential for complications, such as chronic rejection or cancers due to long-term immunosuppression. Those are “major questions requiring more time and careful follow-up.”
‘Still a nascent technology’
“This is an exciting and courageous step forward in heart transplantation, and kudos to the team at the University of Maryland,” said Mandeep R. Mehra, MD, Brigham and Woman’s Hospital, Boston. But “there are many challenges here.”
The procedure’s 10 gene modifications were reportedly aimed at preventing hyperacute rejection of the heart and its excessive growth after transplantation, and making the organ less immunogenic, Dr. Mehra said in an interview. But even if those goals are met, could the same changes potentially impede the heart’s adaptation to human physiology, such as during ambulation or stress?
That kind of adaptation may become important. For example, Dr. Mehra observed, normally a pig heart “provides flow in a four-footed configuration, and pig temperature is inherently higher than humans by several degrees, so it will be functioning in a relatively hypothermic environment.”
Transplantation remains the gold standard for patients with advanced heart failure despite modern medical and device therapy, Dr. Allen agreed. But “if we can raise pig hearts that provide the organ, and it can be implanted with a surgery that’s been done for 50 years, and rejection can be managed with gene editing and tailored immunosuppression, then it’s not hard to think about this very rapidly replacing a lot of what we do in the advanced heart failure and transplantation world.”
Certainly, it would be a major advance if the gene editing technique successfully improves the heart’s immunologic compatibility, Dr. Yancy noted. But do we have enough genomic knowledge to select gene deletions and insertions in the safest way for a successful outcome? “We have to appreciate that this is still a nascent technology, and we should be careful that there might be consequences that we haven’t anticipated.”
For example, he said, the xenotransplantation and gene-modifying techniques should be explored in a range of patients, including older and younger people, women and men, and people of different ethnicities and races.
“There may be some differences based on ancestry, based on gender, based on aging, that will influence the way in which these engineered donor hearts are experienced clinically,” Dr. Yancy said.
The xenotransplantation technique’s potential impact on health equity should also be considered, as it “almost assuredly will be a very expensive technology that will be utilized in a very select population,” he noted. “We need to have a really wide lens to think about all of the potential ramifications.”
‘This field needs to evolve’
Dr. Mehra also flagged the procedure’s potential cost should it become mainstream. Perhaps that would promote dialogue on how to primarily use it “after legitimately exhausting all available options, such as total artificial heart support.”
It might also teach the field to take greater advantage of the many donated hearts discarded as suboptimal. “The general usage rate for offered organs is around a third,” despite opportunities to expand use of those that are “less than perfect,” Dr. Mehra said. “I think that the field will grow with the community focusing on reduced discards of current available heart organs, and not necessarily grow because of the availability of ‘xeno-organs.’ ”
“This field needs to evolve because we’re actively transplanting patients today. But in my mind, the real future is to have such a sufficient understanding of the biology of left ventricular dysfunction that transplantation is a rare event,” Dr. Yancy proposed.
“I’m not certain that heart transplantation per se is the endgame. I think the avoidance of transplantation is the real endgame,” he said. “This may be controversial, but my vision of the future is not one where we have a supply of animals that we can use for transplantation. My vision of the future is that heart transplantation becomes obsolete.”
A version of this article first appeared on Medscape.com.
CDC to update mask recommendations as Omicron spreads
Director Rochelle Walensky, MD, said on Jan. 12.
“We are preparing an update to the info on our mask website to best reflect the options that are available to people and the different levels of protection different masks provide, and we want to provide Americans the best and most updated information to choose what mask is going to be right for them,” she said at a White House news briefing.
While the higher-quality masks provide better protection, they can be uncomfortable to wear, expensive, and harder to find. That’s why Dr. Walensky added an important caveat.
“Any mask is better than no mask, and we do encourage all Americans to wear a well-fitting mask to protect themselves and prevent the spread of COVID-19. That recommendation is not going to change,” she said.
“Most importantly, the best mask that you wear is the one you will wear and the one you can keep on all day long and tolerate in public indoor settings.”
Meanwhile, the World Health Organization was more focused on vaccines.
WHO officials stressed on Jan. 12 that global vaccine distribution is first priority in defeating the highly contagious Omicron variant, as well as other variants that may evolve.
The WHO’s Technical Advisory Group on COVID-19 Vaccine Composition – a group of experts assessing how COVID-19 vaccines perform against Omicron and other emerging variants – says there is an “urgent need” for broader access to vaccines, along with reviewing and updating current vaccines as needed to ensure protection.
The WHO also disputed the idea that COVID-19 could become endemic in one largely vaccinated nation, while the rest of the world remains unprotected.
“It is up to us how this pandemic unfolds,” Maria Van Kerkhove, PhD, the WHO’s technical lead on COVID-19 response, said at a news briefing.
The WHO has a goal of vaccinating 70% of the population of every country by the middle of the year.
But right now, 90 countries have yet to reach 40% vaccination rates, and 36 of those countries have less than 10% of their populations vaccinated, according to WHO Director General Tedros Adhanom Ghebreyesus, PhD.
A staggering 85% of the African population has not received a first dose.
But progress is being made, Dr. Ghebreyesus said at the briefing.
The WHO said there were over 15 million COVID-19 cases reported last week – the most ever in a single week – and this is likely an underestimate.
The Omicron variant, first identified in South Africa 2 months ago and now found on all seven continents, is “rapidly replacing Delta in almost all countries,” Dr. Ghebreyesus said.
Dr. Walensky said this week’s U.S. daily average COVID-19 case count was 751,000, an increase of 47% from last week. The average daily hospital admissions this week is 19,800, an increase of 33%. Deaths are up 40%, reaching 1,600 per day.
But she also reported new data that supports other research showing Omicron may produce less severe disease. Kaiser Permanente Southern California released a study on Jan. 11 showing that, compared with Delta infections, Omicron was associated with a 53% reduction in hospitalizations, a 74% reduction in intensive care unit admissions, and a 91% lower risk of death.
In the study, no patients with Omicron required mechanical ventilation. The strain now accounts for 98% of cases nationwide.
But Dr. Walensky warned the lower disease severity is not enough to make up for the sheer number of cases that continue to overwhelm hospital systems.
“While we are seeing early evidence that Omicron is less severe than Delta and that those infected are less likely to require hospitalization, it’s important to note that Omicron continues to be much more transmissible than Delta,” she said. “The sudden rise in cases due to Omicron is resulting in unprecedented daily case counts, sickness, absenteeism, and strains on our health care system.”
A version of this article first appeared on WebMD.com.
Director Rochelle Walensky, MD, said on Jan. 12.
“We are preparing an update to the info on our mask website to best reflect the options that are available to people and the different levels of protection different masks provide, and we want to provide Americans the best and most updated information to choose what mask is going to be right for them,” she said at a White House news briefing.
While the higher-quality masks provide better protection, they can be uncomfortable to wear, expensive, and harder to find. That’s why Dr. Walensky added an important caveat.
“Any mask is better than no mask, and we do encourage all Americans to wear a well-fitting mask to protect themselves and prevent the spread of COVID-19. That recommendation is not going to change,” she said.
“Most importantly, the best mask that you wear is the one you will wear and the one you can keep on all day long and tolerate in public indoor settings.”
Meanwhile, the World Health Organization was more focused on vaccines.
WHO officials stressed on Jan. 12 that global vaccine distribution is first priority in defeating the highly contagious Omicron variant, as well as other variants that may evolve.
The WHO’s Technical Advisory Group on COVID-19 Vaccine Composition – a group of experts assessing how COVID-19 vaccines perform against Omicron and other emerging variants – says there is an “urgent need” for broader access to vaccines, along with reviewing and updating current vaccines as needed to ensure protection.
The WHO also disputed the idea that COVID-19 could become endemic in one largely vaccinated nation, while the rest of the world remains unprotected.
“It is up to us how this pandemic unfolds,” Maria Van Kerkhove, PhD, the WHO’s technical lead on COVID-19 response, said at a news briefing.
The WHO has a goal of vaccinating 70% of the population of every country by the middle of the year.
But right now, 90 countries have yet to reach 40% vaccination rates, and 36 of those countries have less than 10% of their populations vaccinated, according to WHO Director General Tedros Adhanom Ghebreyesus, PhD.
A staggering 85% of the African population has not received a first dose.
But progress is being made, Dr. Ghebreyesus said at the briefing.
The WHO said there were over 15 million COVID-19 cases reported last week – the most ever in a single week – and this is likely an underestimate.
The Omicron variant, first identified in South Africa 2 months ago and now found on all seven continents, is “rapidly replacing Delta in almost all countries,” Dr. Ghebreyesus said.
Dr. Walensky said this week’s U.S. daily average COVID-19 case count was 751,000, an increase of 47% from last week. The average daily hospital admissions this week is 19,800, an increase of 33%. Deaths are up 40%, reaching 1,600 per day.
But she also reported new data that supports other research showing Omicron may produce less severe disease. Kaiser Permanente Southern California released a study on Jan. 11 showing that, compared with Delta infections, Omicron was associated with a 53% reduction in hospitalizations, a 74% reduction in intensive care unit admissions, and a 91% lower risk of death.
In the study, no patients with Omicron required mechanical ventilation. The strain now accounts for 98% of cases nationwide.
But Dr. Walensky warned the lower disease severity is not enough to make up for the sheer number of cases that continue to overwhelm hospital systems.
“While we are seeing early evidence that Omicron is less severe than Delta and that those infected are less likely to require hospitalization, it’s important to note that Omicron continues to be much more transmissible than Delta,” she said. “The sudden rise in cases due to Omicron is resulting in unprecedented daily case counts, sickness, absenteeism, and strains on our health care system.”
A version of this article first appeared on WebMD.com.
Director Rochelle Walensky, MD, said on Jan. 12.
“We are preparing an update to the info on our mask website to best reflect the options that are available to people and the different levels of protection different masks provide, and we want to provide Americans the best and most updated information to choose what mask is going to be right for them,” she said at a White House news briefing.
While the higher-quality masks provide better protection, they can be uncomfortable to wear, expensive, and harder to find. That’s why Dr. Walensky added an important caveat.
“Any mask is better than no mask, and we do encourage all Americans to wear a well-fitting mask to protect themselves and prevent the spread of COVID-19. That recommendation is not going to change,” she said.
“Most importantly, the best mask that you wear is the one you will wear and the one you can keep on all day long and tolerate in public indoor settings.”
Meanwhile, the World Health Organization was more focused on vaccines.
WHO officials stressed on Jan. 12 that global vaccine distribution is first priority in defeating the highly contagious Omicron variant, as well as other variants that may evolve.
The WHO’s Technical Advisory Group on COVID-19 Vaccine Composition – a group of experts assessing how COVID-19 vaccines perform against Omicron and other emerging variants – says there is an “urgent need” for broader access to vaccines, along with reviewing and updating current vaccines as needed to ensure protection.
The WHO also disputed the idea that COVID-19 could become endemic in one largely vaccinated nation, while the rest of the world remains unprotected.
“It is up to us how this pandemic unfolds,” Maria Van Kerkhove, PhD, the WHO’s technical lead on COVID-19 response, said at a news briefing.
The WHO has a goal of vaccinating 70% of the population of every country by the middle of the year.
But right now, 90 countries have yet to reach 40% vaccination rates, and 36 of those countries have less than 10% of their populations vaccinated, according to WHO Director General Tedros Adhanom Ghebreyesus, PhD.
A staggering 85% of the African population has not received a first dose.
But progress is being made, Dr. Ghebreyesus said at the briefing.
The WHO said there were over 15 million COVID-19 cases reported last week – the most ever in a single week – and this is likely an underestimate.
The Omicron variant, first identified in South Africa 2 months ago and now found on all seven continents, is “rapidly replacing Delta in almost all countries,” Dr. Ghebreyesus said.
Dr. Walensky said this week’s U.S. daily average COVID-19 case count was 751,000, an increase of 47% from last week. The average daily hospital admissions this week is 19,800, an increase of 33%. Deaths are up 40%, reaching 1,600 per day.
But she also reported new data that supports other research showing Omicron may produce less severe disease. Kaiser Permanente Southern California released a study on Jan. 11 showing that, compared with Delta infections, Omicron was associated with a 53% reduction in hospitalizations, a 74% reduction in intensive care unit admissions, and a 91% lower risk of death.
In the study, no patients with Omicron required mechanical ventilation. The strain now accounts for 98% of cases nationwide.
But Dr. Walensky warned the lower disease severity is not enough to make up for the sheer number of cases that continue to overwhelm hospital systems.
“While we are seeing early evidence that Omicron is less severe than Delta and that those infected are less likely to require hospitalization, it’s important to note that Omicron continues to be much more transmissible than Delta,” she said. “The sudden rise in cases due to Omicron is resulting in unprecedented daily case counts, sickness, absenteeism, and strains on our health care system.”
A version of this article first appeared on WebMD.com.
Ranking seven COVID-19 antigen tests by ease of use: Report
Some COVID-19 rapid antigen home test kits are much easier to use than others, according to an analysis by ECRI, an independent, nonprofit patient safety organization.
None of the tests were rated as “excellent” in terms of usability and some had “noteworthy” usability concerns, the company said.
If a test is hard to use, “chances are that you may miss a step or not follow the right order, or contaminate the testing area and that can definitely influence the accuracy of the test and lead to a wrong test result,” Marcus Schabacker, MD, PhD, president and CEO of ECRI, told this news organization.
To gauge usability, ECRI used the “industry-standard” system usability scale (SUS), which rates products on a scale of 0 to 100 with 100 being the easiest to use.
More than 30 points separated the top and bottom tests analyzed. The top performer was On/Go, followed by CareStart and Flowflex.
ECRI analysts found that some tests require particularly fine motor skills or have instructions with extremely small font size that may make it hard for older adults or people with complex health conditions to use the tests correctly.
“If you have a tremor from Parkinson’s, for example, or anything which won’t allow you to handle small items, you will have difficulties to do that test by yourself. That is the No. 1 concern we have,” Dr. Schabacker said.
“The second concern is readability, as all of these tests have relatively small instructions. One of them actually has doesn’t even have instructions – you have to download an app,” he noted.
Given demand and supply issues, Dr. Schabacker acknowledged that consumers might not have a choice in which test to use and may have to rely on whatever is available.
These tests are a “hot commodity right now,” he said. “If you have a choice, people should use the ones which are easiest to use, which is the On/Go, the CareStart, or the Flowflex.”
A version of this article first appeared on Medscape.com.
Some COVID-19 rapid antigen home test kits are much easier to use than others, according to an analysis by ECRI, an independent, nonprofit patient safety organization.
None of the tests were rated as “excellent” in terms of usability and some had “noteworthy” usability concerns, the company said.
If a test is hard to use, “chances are that you may miss a step or not follow the right order, or contaminate the testing area and that can definitely influence the accuracy of the test and lead to a wrong test result,” Marcus Schabacker, MD, PhD, president and CEO of ECRI, told this news organization.
To gauge usability, ECRI used the “industry-standard” system usability scale (SUS), which rates products on a scale of 0 to 100 with 100 being the easiest to use.
More than 30 points separated the top and bottom tests analyzed. The top performer was On/Go, followed by CareStart and Flowflex.
ECRI analysts found that some tests require particularly fine motor skills or have instructions with extremely small font size that may make it hard for older adults or people with complex health conditions to use the tests correctly.
“If you have a tremor from Parkinson’s, for example, or anything which won’t allow you to handle small items, you will have difficulties to do that test by yourself. That is the No. 1 concern we have,” Dr. Schabacker said.
“The second concern is readability, as all of these tests have relatively small instructions. One of them actually has doesn’t even have instructions – you have to download an app,” he noted.
Given demand and supply issues, Dr. Schabacker acknowledged that consumers might not have a choice in which test to use and may have to rely on whatever is available.
These tests are a “hot commodity right now,” he said. “If you have a choice, people should use the ones which are easiest to use, which is the On/Go, the CareStart, or the Flowflex.”
A version of this article first appeared on Medscape.com.
Some COVID-19 rapid antigen home test kits are much easier to use than others, according to an analysis by ECRI, an independent, nonprofit patient safety organization.
None of the tests were rated as “excellent” in terms of usability and some had “noteworthy” usability concerns, the company said.
If a test is hard to use, “chances are that you may miss a step or not follow the right order, or contaminate the testing area and that can definitely influence the accuracy of the test and lead to a wrong test result,” Marcus Schabacker, MD, PhD, president and CEO of ECRI, told this news organization.
To gauge usability, ECRI used the “industry-standard” system usability scale (SUS), which rates products on a scale of 0 to 100 with 100 being the easiest to use.
More than 30 points separated the top and bottom tests analyzed. The top performer was On/Go, followed by CareStart and Flowflex.
ECRI analysts found that some tests require particularly fine motor skills or have instructions with extremely small font size that may make it hard for older adults or people with complex health conditions to use the tests correctly.
“If you have a tremor from Parkinson’s, for example, or anything which won’t allow you to handle small items, you will have difficulties to do that test by yourself. That is the No. 1 concern we have,” Dr. Schabacker said.
“The second concern is readability, as all of these tests have relatively small instructions. One of them actually has doesn’t even have instructions – you have to download an app,” he noted.
Given demand and supply issues, Dr. Schabacker acknowledged that consumers might not have a choice in which test to use and may have to rely on whatever is available.
These tests are a “hot commodity right now,” he said. “If you have a choice, people should use the ones which are easiest to use, which is the On/Go, the CareStart, or the Flowflex.”
A version of this article first appeared on Medscape.com.
Physicians react: Should docs lose their licenses for spreading false COVID information?
Doctors providing “fraudulent” COVID-19 information became a hot-button issue for physicians responding to Medscape’s recent article, "Shouldn’t Doctors Who Spread False COVID-19 Information Lose Their Licenses?”
COVID-19 safety recommendations are set by mainstream medical organizations as new information becomes available, but some doctors consistently oppose advice from the Centers for Disease Control and Prevention and other medical authorities. These physicians often promote off-label, unapproved use of medications for COVID-19 and/or contradict mainstream safety guidelines such as vaccines, masks, and social distancing.
Some medical organizations are concerned that these doctors are hampering efforts to control the highly contagious coronavirus and are, at worst, placing lives in danger with their contrarian views that can spread like wildfire on social media sites. Their words are often used by those who refuse to be vaccinated or wear masks.
State licensing boards have mostly refused to discipline these doctors for making false and/or misleading claims, but as the virus spreads, there are calls to take action against them. However, others worry that such actions would violate free speech and critical thought.
Yes, those doctors are doing wrong
Several physicians took a strong stand against their fellow doctors who are spreading misinformation about COVID-19.
One doctor endorsed the idea of removing licenses for spreading misinformation and called for criminal prosecution: “It should certainly be grounds for cancellation of all licensing (after appropriate examination to rule out acute psychotic episodes, dementia, tumor, etc.) and very likely [include] a charge of manslaughter.”
Another health care provider said, “A person who does not accept science should not, of course, be allowed to practice medicine. One who argues publicly that vaccines and masks don’t work should be prosecuted for crimes ranging from reckless endangerment to attempted murder.”
One reader framed COVID-19 misinformers in stark terms: “These men and women are medical prostitutes. Their medical and surgical colleges [should] have a panel to track in-court testimony and the disinformation they spread ...”
“This is malpractice of the worst kind,” said a clinician. “Public health officials and science are quite clear on [the] best practices for safety during a pandemic, which is killing millions. This is a standard of care.”
“Medical Boards should suspend licenses and give the physician a chance to testify [about] the scientific basis for his comments,” added a health care provider. “Boards involve themselves in all kinds of perceived disciplinary infractions. We are in the midst of a lethal pandemic. I would think that would take precedence over many other issues?”
“I do believe that physicians have the responsibility to speak the truth and have scientifically displayed minds,” said a reader. “Not [to] promulgate misleading, false, and/or unverified information.”
“Any physician, who holds a license, should abide [by] government and state regulation,” asserted a doctor. “He should be disciplined by the board for spreading medical/public misinformation since he is creating potential harm to the population.”
One specialist insisted that “state boards do not do enough to restrict/limit the practice of physicians touting questionable therapies.”
“Any doctor who spreads false information about Covid is hurting our country, our individuals, and our economy and leading to needless deaths,” asserted a physician. “However, there are uncertainties, and where those exist, physicians [should] simply say ‘it is unknown.’”
No, those physicians have a right to speak their beliefs
However, many physicians worried that science and controversial thought were being muzzled.
“Absolutely no,” a doctor stated. “Who judges what is misinformation in this age where debate is canceled? Science advances with challenge, and it’s not about an authority dictating the allowable opinion.”
Another clinician claimed the “truth is very difficult to discern from less-than-truth in a country running on a profit-oriented economic ideology.”
One specialist warned that if disinformation doctors are held responsible, then “that means a lot of doctors” will be “gone” because “almost anything that is written or said about COVID can be contested.”
Another physician warned his colleagues about suppressing new ideas: “To condemn what we didn’t try, or purposefully ignore a different approach because [it] doesn’t agree with our opinion is suppression of information.”
Some doctors insisted the issue extended beyond medicine and into Constitutional freedoms. They also expressed their mistrust in the government to regulate physicians.
“There is a First Amendment in this country,” said one reader. “What you think is false may not be so. The people can listen to whoever they want to and make their own medical decisions. We do not need one iota more of politicizing medicine. Having an MD or DO does not mean you relinquish your First Amendment rights.”
“One of the fundamental problems with a system that allows government to ‘license’ physicians, or any other profession, is that politics inevitably turn to cronyism, and big businesses and wealthy people start controlling the government,” argued a doctor.
One clinician suggested enforcement against health food, drug company commercials, and talk shows: “What about all the [misinformation] at the health food stores and the like. Doctors of natural-whatever? Those info-commercials on tv. How many faxes do I get to ‘approve’ because ‘patients request’ braces and pain-treating expensive compounds advertised on TV? We tolerate those ... What about Dr. Oz and the docs on talk shows claiming BS?”
And the debate goes even further
Some physicians questioned the very notion of claiming “truth.”
“Nobody should be certain that they have the ‘absolute truth,’” said one reader. “In fact, the best clinical insights exceed so-called knowledge by at least one step.”
“Who can determine exactly what is truth?” asked another clinician. “For sure, the ‘Federal Government,’ who ‘is here to help you,’ is not qualified to make such determinations, and who are you to make such a suggestion as to remove someone’s license because they disagree with you? Give me a break!”
Another physician echoed that sentiment: “What’s true and false is often and certainly currently debatable. There are well-qualified physicians (with credentials such as the development of mRNA technology), virologists, and biostatisticians that have valid thoughts on this but do not necessarily agree with the drug company-sponsored journals and news channels (most of them). Their voices should be heard, and they should not lose their licenses. They are doing their work in good conscience.”
One reader commented that he wanted his “freedom of speech,” and offered this defiant advice: “You can take this license and shove it.”
Finally, a physician noted that the political climate has influenced medical directives: “If someone in a leadership role knowingly, and with intent, spread false information, that is wrong. However, during this global pandemic the active and the politics have combined. Red state no mandate, blue state mandate – what does that tell you about American leadership?”
A version of this article first appeared on Medscape.com.
Doctors providing “fraudulent” COVID-19 information became a hot-button issue for physicians responding to Medscape’s recent article, "Shouldn’t Doctors Who Spread False COVID-19 Information Lose Their Licenses?”
COVID-19 safety recommendations are set by mainstream medical organizations as new information becomes available, but some doctors consistently oppose advice from the Centers for Disease Control and Prevention and other medical authorities. These physicians often promote off-label, unapproved use of medications for COVID-19 and/or contradict mainstream safety guidelines such as vaccines, masks, and social distancing.
Some medical organizations are concerned that these doctors are hampering efforts to control the highly contagious coronavirus and are, at worst, placing lives in danger with their contrarian views that can spread like wildfire on social media sites. Their words are often used by those who refuse to be vaccinated or wear masks.
State licensing boards have mostly refused to discipline these doctors for making false and/or misleading claims, but as the virus spreads, there are calls to take action against them. However, others worry that such actions would violate free speech and critical thought.
Yes, those doctors are doing wrong
Several physicians took a strong stand against their fellow doctors who are spreading misinformation about COVID-19.
One doctor endorsed the idea of removing licenses for spreading misinformation and called for criminal prosecution: “It should certainly be grounds for cancellation of all licensing (after appropriate examination to rule out acute psychotic episodes, dementia, tumor, etc.) and very likely [include] a charge of manslaughter.”
Another health care provider said, “A person who does not accept science should not, of course, be allowed to practice medicine. One who argues publicly that vaccines and masks don’t work should be prosecuted for crimes ranging from reckless endangerment to attempted murder.”
One reader framed COVID-19 misinformers in stark terms: “These men and women are medical prostitutes. Their medical and surgical colleges [should] have a panel to track in-court testimony and the disinformation they spread ...”
“This is malpractice of the worst kind,” said a clinician. “Public health officials and science are quite clear on [the] best practices for safety during a pandemic, which is killing millions. This is a standard of care.”
“Medical Boards should suspend licenses and give the physician a chance to testify [about] the scientific basis for his comments,” added a health care provider. “Boards involve themselves in all kinds of perceived disciplinary infractions. We are in the midst of a lethal pandemic. I would think that would take precedence over many other issues?”
“I do believe that physicians have the responsibility to speak the truth and have scientifically displayed minds,” said a reader. “Not [to] promulgate misleading, false, and/or unverified information.”
“Any physician, who holds a license, should abide [by] government and state regulation,” asserted a doctor. “He should be disciplined by the board for spreading medical/public misinformation since he is creating potential harm to the population.”
One specialist insisted that “state boards do not do enough to restrict/limit the practice of physicians touting questionable therapies.”
“Any doctor who spreads false information about Covid is hurting our country, our individuals, and our economy and leading to needless deaths,” asserted a physician. “However, there are uncertainties, and where those exist, physicians [should] simply say ‘it is unknown.’”
No, those physicians have a right to speak their beliefs
However, many physicians worried that science and controversial thought were being muzzled.
“Absolutely no,” a doctor stated. “Who judges what is misinformation in this age where debate is canceled? Science advances with challenge, and it’s not about an authority dictating the allowable opinion.”
Another clinician claimed the “truth is very difficult to discern from less-than-truth in a country running on a profit-oriented economic ideology.”
One specialist warned that if disinformation doctors are held responsible, then “that means a lot of doctors” will be “gone” because “almost anything that is written or said about COVID can be contested.”
Another physician warned his colleagues about suppressing new ideas: “To condemn what we didn’t try, or purposefully ignore a different approach because [it] doesn’t agree with our opinion is suppression of information.”
Some doctors insisted the issue extended beyond medicine and into Constitutional freedoms. They also expressed their mistrust in the government to regulate physicians.
“There is a First Amendment in this country,” said one reader. “What you think is false may not be so. The people can listen to whoever they want to and make their own medical decisions. We do not need one iota more of politicizing medicine. Having an MD or DO does not mean you relinquish your First Amendment rights.”
“One of the fundamental problems with a system that allows government to ‘license’ physicians, or any other profession, is that politics inevitably turn to cronyism, and big businesses and wealthy people start controlling the government,” argued a doctor.
One clinician suggested enforcement against health food, drug company commercials, and talk shows: “What about all the [misinformation] at the health food stores and the like. Doctors of natural-whatever? Those info-commercials on tv. How many faxes do I get to ‘approve’ because ‘patients request’ braces and pain-treating expensive compounds advertised on TV? We tolerate those ... What about Dr. Oz and the docs on talk shows claiming BS?”
And the debate goes even further
Some physicians questioned the very notion of claiming “truth.”
“Nobody should be certain that they have the ‘absolute truth,’” said one reader. “In fact, the best clinical insights exceed so-called knowledge by at least one step.”
“Who can determine exactly what is truth?” asked another clinician. “For sure, the ‘Federal Government,’ who ‘is here to help you,’ is not qualified to make such determinations, and who are you to make such a suggestion as to remove someone’s license because they disagree with you? Give me a break!”
Another physician echoed that sentiment: “What’s true and false is often and certainly currently debatable. There are well-qualified physicians (with credentials such as the development of mRNA technology), virologists, and biostatisticians that have valid thoughts on this but do not necessarily agree with the drug company-sponsored journals and news channels (most of them). Their voices should be heard, and they should not lose their licenses. They are doing their work in good conscience.”
One reader commented that he wanted his “freedom of speech,” and offered this defiant advice: “You can take this license and shove it.”
Finally, a physician noted that the political climate has influenced medical directives: “If someone in a leadership role knowingly, and with intent, spread false information, that is wrong. However, during this global pandemic the active and the politics have combined. Red state no mandate, blue state mandate – what does that tell you about American leadership?”
A version of this article first appeared on Medscape.com.
Doctors providing “fraudulent” COVID-19 information became a hot-button issue for physicians responding to Medscape’s recent article, "Shouldn’t Doctors Who Spread False COVID-19 Information Lose Their Licenses?”
COVID-19 safety recommendations are set by mainstream medical organizations as new information becomes available, but some doctors consistently oppose advice from the Centers for Disease Control and Prevention and other medical authorities. These physicians often promote off-label, unapproved use of medications for COVID-19 and/or contradict mainstream safety guidelines such as vaccines, masks, and social distancing.
Some medical organizations are concerned that these doctors are hampering efforts to control the highly contagious coronavirus and are, at worst, placing lives in danger with their contrarian views that can spread like wildfire on social media sites. Their words are often used by those who refuse to be vaccinated or wear masks.
State licensing boards have mostly refused to discipline these doctors for making false and/or misleading claims, but as the virus spreads, there are calls to take action against them. However, others worry that such actions would violate free speech and critical thought.
Yes, those doctors are doing wrong
Several physicians took a strong stand against their fellow doctors who are spreading misinformation about COVID-19.
One doctor endorsed the idea of removing licenses for spreading misinformation and called for criminal prosecution: “It should certainly be grounds for cancellation of all licensing (after appropriate examination to rule out acute psychotic episodes, dementia, tumor, etc.) and very likely [include] a charge of manslaughter.”
Another health care provider said, “A person who does not accept science should not, of course, be allowed to practice medicine. One who argues publicly that vaccines and masks don’t work should be prosecuted for crimes ranging from reckless endangerment to attempted murder.”
One reader framed COVID-19 misinformers in stark terms: “These men and women are medical prostitutes. Their medical and surgical colleges [should] have a panel to track in-court testimony and the disinformation they spread ...”
“This is malpractice of the worst kind,” said a clinician. “Public health officials and science are quite clear on [the] best practices for safety during a pandemic, which is killing millions. This is a standard of care.”
“Medical Boards should suspend licenses and give the physician a chance to testify [about] the scientific basis for his comments,” added a health care provider. “Boards involve themselves in all kinds of perceived disciplinary infractions. We are in the midst of a lethal pandemic. I would think that would take precedence over many other issues?”
“I do believe that physicians have the responsibility to speak the truth and have scientifically displayed minds,” said a reader. “Not [to] promulgate misleading, false, and/or unverified information.”
“Any physician, who holds a license, should abide [by] government and state regulation,” asserted a doctor. “He should be disciplined by the board for spreading medical/public misinformation since he is creating potential harm to the population.”
One specialist insisted that “state boards do not do enough to restrict/limit the practice of physicians touting questionable therapies.”
“Any doctor who spreads false information about Covid is hurting our country, our individuals, and our economy and leading to needless deaths,” asserted a physician. “However, there are uncertainties, and where those exist, physicians [should] simply say ‘it is unknown.’”
No, those physicians have a right to speak their beliefs
However, many physicians worried that science and controversial thought were being muzzled.
“Absolutely no,” a doctor stated. “Who judges what is misinformation in this age where debate is canceled? Science advances with challenge, and it’s not about an authority dictating the allowable opinion.”
Another clinician claimed the “truth is very difficult to discern from less-than-truth in a country running on a profit-oriented economic ideology.”
One specialist warned that if disinformation doctors are held responsible, then “that means a lot of doctors” will be “gone” because “almost anything that is written or said about COVID can be contested.”
Another physician warned his colleagues about suppressing new ideas: “To condemn what we didn’t try, or purposefully ignore a different approach because [it] doesn’t agree with our opinion is suppression of information.”
Some doctors insisted the issue extended beyond medicine and into Constitutional freedoms. They also expressed their mistrust in the government to regulate physicians.
“There is a First Amendment in this country,” said one reader. “What you think is false may not be so. The people can listen to whoever they want to and make their own medical decisions. We do not need one iota more of politicizing medicine. Having an MD or DO does not mean you relinquish your First Amendment rights.”
“One of the fundamental problems with a system that allows government to ‘license’ physicians, or any other profession, is that politics inevitably turn to cronyism, and big businesses and wealthy people start controlling the government,” argued a doctor.
One clinician suggested enforcement against health food, drug company commercials, and talk shows: “What about all the [misinformation] at the health food stores and the like. Doctors of natural-whatever? Those info-commercials on tv. How many faxes do I get to ‘approve’ because ‘patients request’ braces and pain-treating expensive compounds advertised on TV? We tolerate those ... What about Dr. Oz and the docs on talk shows claiming BS?”
And the debate goes even further
Some physicians questioned the very notion of claiming “truth.”
“Nobody should be certain that they have the ‘absolute truth,’” said one reader. “In fact, the best clinical insights exceed so-called knowledge by at least one step.”
“Who can determine exactly what is truth?” asked another clinician. “For sure, the ‘Federal Government,’ who ‘is here to help you,’ is not qualified to make such determinations, and who are you to make such a suggestion as to remove someone’s license because they disagree with you? Give me a break!”
Another physician echoed that sentiment: “What’s true and false is often and certainly currently debatable. There are well-qualified physicians (with credentials such as the development of mRNA technology), virologists, and biostatisticians that have valid thoughts on this but do not necessarily agree with the drug company-sponsored journals and news channels (most of them). Their voices should be heard, and they should not lose their licenses. They are doing their work in good conscience.”
One reader commented that he wanted his “freedom of speech,” and offered this defiant advice: “You can take this license and shove it.”
Finally, a physician noted that the political climate has influenced medical directives: “If someone in a leadership role knowingly, and with intent, spread false information, that is wrong. However, during this global pandemic the active and the politics have combined. Red state no mandate, blue state mandate – what does that tell you about American leadership?”
A version of this article first appeared on Medscape.com.
‘Highly encouraging’ MRD results for zanubrutinib add-on in CLL
Treatment was stopped in the single-arm phase 2 trial when patients reached undetectable MRD, a novel use of MRD to guide treatment duration. At a median of 16 months after discontinuation, MRD remained undetectable in 31 of 33 patients (94%).
The team also found that a reduction to 1/400 of baseline MRD (delta-MRD400) by day 1 of cycle five predicted undetectable bone marrow MRD within eight treatment cycles.
delta-MRD400 is “a potential biomarker” to identify patients who’ll do well with a shorter treatment and flag others who require longer courses of therapy, said investigators led by Jacob Soumerai, MD, a hematologist/oncologist at Massachusetts General Hospital, Boston.
Overall, the results “are highly encouraging,” they said, with efficacy and safety comparing favorably to trials that added other BTK inhibitors – namely ibrutinib and acalabrutinib – to the standard obinutuzumab/venetoclax backbone, with a shorter treatment duration.
They said the novel triplet warrants further study in the first line and noted that they also “plan to prospectively validate early-MRD-response kinetics as a biomarker to guide treatment duration.” The study was published recently in The Lancet Haematology.
Two editorialists – Davide Rossi, MD, PhD, and Joyce Marques De Almeida, both of the of the Oncology Institute of Southern Switzerland, Bellinzona – were encouraged by the findings and wanted future research to assess how well MRD-guided treatment duration works in patients with tumor protein p53-disrupted disease, who “benefit less from time-limited therapies” then patients with wild-type TP53; the trial was too small to address the issue.
There was a two-cycle lead-in with zanubrutinib and obinutuzumab then venetoclax ramp-up starting at cycle 3, with each cycle running 28 days.
Zanubrutinib is approved in the U.S. for mantle cell lymphoma, Waldenström’s macroglobulinemia, and marginal zone lymphoma.
In a previous phase 2 trial of ibrutinib add-on to venetoclax-obinutuzumab for 14 cycles followed by ibrutinib monotherapy, the rate of undetectable MRD in both peripheral blood and bone marrow was 67%. The rate of bone marrow undetectable MRD was 77% in another phase 2 trial of acalabrutinib, venetoclax, and obinutuzumab for at least 15 cycles.
Dr. Soumerai and his team cautioned, however, that “comparisons across trials are fraught with selection bias resulting in differences in treated patient populations, and randomized data are needed to establish the optimal BTK inhibitor to combine with venetoclax with or without obinutuzumab, and to establish whether” the zanubrutinib triplet “improves progression-free survival and overall survival compared with current standard first-line therapy.”
There was grade 3 or worse neutropenia in 18% of subjects (7/39), one episode of febrile neutropenia (3%), lung infections in three patients (8%) patients, and five cases of hypertension (13%).
The editorialists characterized the numbers as low and the regimen as well tolerated. Past studies of ibrutinib, a first generation BTK, with venetoclax and obinutuzumab have pegged grade 3 or worse neutropenia at 56% and the hypertension incidence at 48%.
Granulocyte colony-stimulating factor administration “could partially account for the low incidence of severe neutropenia” in the trial, the investigators said.
The study was funded by zanubrutinib marketer Beigene as well as Genentech, the National Cancer Institute, and others. Many of the authors had industry ties, including Dr. Soumerai who reported being a consultant and researcher for Beigene and other companies. Dr. Rossi reported honoraria and research grants from AbbVie, AstraZeneca, and Janssen.
Treatment was stopped in the single-arm phase 2 trial when patients reached undetectable MRD, a novel use of MRD to guide treatment duration. At a median of 16 months after discontinuation, MRD remained undetectable in 31 of 33 patients (94%).
The team also found that a reduction to 1/400 of baseline MRD (delta-MRD400) by day 1 of cycle five predicted undetectable bone marrow MRD within eight treatment cycles.
delta-MRD400 is “a potential biomarker” to identify patients who’ll do well with a shorter treatment and flag others who require longer courses of therapy, said investigators led by Jacob Soumerai, MD, a hematologist/oncologist at Massachusetts General Hospital, Boston.
Overall, the results “are highly encouraging,” they said, with efficacy and safety comparing favorably to trials that added other BTK inhibitors – namely ibrutinib and acalabrutinib – to the standard obinutuzumab/venetoclax backbone, with a shorter treatment duration.
They said the novel triplet warrants further study in the first line and noted that they also “plan to prospectively validate early-MRD-response kinetics as a biomarker to guide treatment duration.” The study was published recently in The Lancet Haematology.
Two editorialists – Davide Rossi, MD, PhD, and Joyce Marques De Almeida, both of the of the Oncology Institute of Southern Switzerland, Bellinzona – were encouraged by the findings and wanted future research to assess how well MRD-guided treatment duration works in patients with tumor protein p53-disrupted disease, who “benefit less from time-limited therapies” then patients with wild-type TP53; the trial was too small to address the issue.
There was a two-cycle lead-in with zanubrutinib and obinutuzumab then venetoclax ramp-up starting at cycle 3, with each cycle running 28 days.
Zanubrutinib is approved in the U.S. for mantle cell lymphoma, Waldenström’s macroglobulinemia, and marginal zone lymphoma.
In a previous phase 2 trial of ibrutinib add-on to venetoclax-obinutuzumab for 14 cycles followed by ibrutinib monotherapy, the rate of undetectable MRD in both peripheral blood and bone marrow was 67%. The rate of bone marrow undetectable MRD was 77% in another phase 2 trial of acalabrutinib, venetoclax, and obinutuzumab for at least 15 cycles.
Dr. Soumerai and his team cautioned, however, that “comparisons across trials are fraught with selection bias resulting in differences in treated patient populations, and randomized data are needed to establish the optimal BTK inhibitor to combine with venetoclax with or without obinutuzumab, and to establish whether” the zanubrutinib triplet “improves progression-free survival and overall survival compared with current standard first-line therapy.”
There was grade 3 or worse neutropenia in 18% of subjects (7/39), one episode of febrile neutropenia (3%), lung infections in three patients (8%) patients, and five cases of hypertension (13%).
The editorialists characterized the numbers as low and the regimen as well tolerated. Past studies of ibrutinib, a first generation BTK, with venetoclax and obinutuzumab have pegged grade 3 or worse neutropenia at 56% and the hypertension incidence at 48%.
Granulocyte colony-stimulating factor administration “could partially account for the low incidence of severe neutropenia” in the trial, the investigators said.
The study was funded by zanubrutinib marketer Beigene as well as Genentech, the National Cancer Institute, and others. Many of the authors had industry ties, including Dr. Soumerai who reported being a consultant and researcher for Beigene and other companies. Dr. Rossi reported honoraria and research grants from AbbVie, AstraZeneca, and Janssen.
Treatment was stopped in the single-arm phase 2 trial when patients reached undetectable MRD, a novel use of MRD to guide treatment duration. At a median of 16 months after discontinuation, MRD remained undetectable in 31 of 33 patients (94%).
The team also found that a reduction to 1/400 of baseline MRD (delta-MRD400) by day 1 of cycle five predicted undetectable bone marrow MRD within eight treatment cycles.
delta-MRD400 is “a potential biomarker” to identify patients who’ll do well with a shorter treatment and flag others who require longer courses of therapy, said investigators led by Jacob Soumerai, MD, a hematologist/oncologist at Massachusetts General Hospital, Boston.
Overall, the results “are highly encouraging,” they said, with efficacy and safety comparing favorably to trials that added other BTK inhibitors – namely ibrutinib and acalabrutinib – to the standard obinutuzumab/venetoclax backbone, with a shorter treatment duration.
They said the novel triplet warrants further study in the first line and noted that they also “plan to prospectively validate early-MRD-response kinetics as a biomarker to guide treatment duration.” The study was published recently in The Lancet Haematology.
Two editorialists – Davide Rossi, MD, PhD, and Joyce Marques De Almeida, both of the of the Oncology Institute of Southern Switzerland, Bellinzona – were encouraged by the findings and wanted future research to assess how well MRD-guided treatment duration works in patients with tumor protein p53-disrupted disease, who “benefit less from time-limited therapies” then patients with wild-type TP53; the trial was too small to address the issue.
There was a two-cycle lead-in with zanubrutinib and obinutuzumab then venetoclax ramp-up starting at cycle 3, with each cycle running 28 days.
Zanubrutinib is approved in the U.S. for mantle cell lymphoma, Waldenström’s macroglobulinemia, and marginal zone lymphoma.
In a previous phase 2 trial of ibrutinib add-on to venetoclax-obinutuzumab for 14 cycles followed by ibrutinib monotherapy, the rate of undetectable MRD in both peripheral blood and bone marrow was 67%. The rate of bone marrow undetectable MRD was 77% in another phase 2 trial of acalabrutinib, venetoclax, and obinutuzumab for at least 15 cycles.
Dr. Soumerai and his team cautioned, however, that “comparisons across trials are fraught with selection bias resulting in differences in treated patient populations, and randomized data are needed to establish the optimal BTK inhibitor to combine with venetoclax with or without obinutuzumab, and to establish whether” the zanubrutinib triplet “improves progression-free survival and overall survival compared with current standard first-line therapy.”
There was grade 3 or worse neutropenia in 18% of subjects (7/39), one episode of febrile neutropenia (3%), lung infections in three patients (8%) patients, and five cases of hypertension (13%).
The editorialists characterized the numbers as low and the regimen as well tolerated. Past studies of ibrutinib, a first generation BTK, with venetoclax and obinutuzumab have pegged grade 3 or worse neutropenia at 56% and the hypertension incidence at 48%.
Granulocyte colony-stimulating factor administration “could partially account for the low incidence of severe neutropenia” in the trial, the investigators said.
The study was funded by zanubrutinib marketer Beigene as well as Genentech, the National Cancer Institute, and others. Many of the authors had industry ties, including Dr. Soumerai who reported being a consultant and researcher for Beigene and other companies. Dr. Rossi reported honoraria and research grants from AbbVie, AstraZeneca, and Janssen.
FROM THE LANCET HEMATOLOGY
Much lower risk of false-positive breast screen in Norway versus U.S.
Nearly 1 in 5 women who receive the recommended 10 biennial screening rounds for breast cancer in Norway will get a false positive result, and 1 in 20 women will receive a false positive result that leads to an invasive procedure, a new analysis shows.
While the risk may seem high, it is actually much lower than what researchers have reported in the U.S., the study authors note in their paper, published online Dec. 21 in Cancer.
“I am proud about the low rate of recalls we have in Norway and Europe – and hope we can keep it that low for the future,” said senior author Solveig Hofvind, PhD, head of BreastScreen Norway, a nationwide screening program that invites women aged 50 to 69 to mammographic screening every other year.
“The double reading in Europe is probably the main reason for the lower rate in Europe compared to the U.S., where single reading is used,” she said in an interview.
Until now, Dr. Hofvind and her colleagues say, no studies have been performed using exclusively empirical data to describe the cumulative risk of experiencing a false positive screening result in Europe because of the need for long-term follow-up and complete data registration.
For their study, the researchers turned to the Cancer Registry of Norway, which administers BreastScreen Norway. They focused on data from 1995 to 2019 on women aged 50 to 69 years who had attended one or more screening rounds and could potentially attend all 10 screening examinations over the 20-year period.
Women were excluded if they were diagnosed with breast cancer before attending screening, participated in interventional research, self-referred for screening, were recalled due to self-reported symptoms or technically inadequate mammograms, or declined follow-up after a positive screen.
Among more than 421,000 women who underwent nearly 1.9 million screening examinations, 11.3% experienced at least one false positive result and 3.3% experienced at least one false positive involving an invasive procedure, such as fine-needle aspiration cytology, core-needle biopsy, or open biopsy.
The cumulative risk of experiencing a first false positive screen was 18.0% and that of experiencing a false positive that involved an invasive procedure was 5.01%. Adjusting for irregular attendance, age at screening, or the number of screens attended had little effect on the estimates.
The results closely match earlier findings from Norway that have been based on assumptions rather than exclusively empirical data. However, these findings differ from results reported in U.S. studies, which have relied largely on data from the Breast Cancer Surveillance Consortium, the researchers say.
“The latter have indicated that, for women who initiate biennial screening at the age of 50 years, the cumulative risk after 10 years is 42% for experiencing at least one false-positive screening result and 6.4% for experiencing at least one false-positive screening result involving an invasive procedure,” Dr. Hofvind and her colleagues write.
Several principal investigators with the Breast Cancer Surveillance Consortium did not respond or were unavailable for comment when contacted by this news organization.
However, the study authors highlighted several factors that could help explain the discrepancy between the U.S. and European results.
In addition to double mammogram reading, “European guidelines recommend that breast radiologists read 3,500 to 11,000 mammograms annually, whereas 960 every 2 years are required by the U.S. Mammography Quality Standards Act,” the researchers note. They also point out that previous screening mammograms are readily available in Norway, whereas this is not always the case in the U.S.
“False-positive screening results are a part of the screening for breast cancer – and the women need to be informed about the risk,” Dr. Hofvind concluded. “The screening programs should aim to keep the rate as low as possible for the women [given] the costs.”
The study was supported by the Dam Foundation via the Norwegian Breast Cancer Society.
A version of this article first appeared on Medscape.com.
Nearly 1 in 5 women who receive the recommended 10 biennial screening rounds for breast cancer in Norway will get a false positive result, and 1 in 20 women will receive a false positive result that leads to an invasive procedure, a new analysis shows.
While the risk may seem high, it is actually much lower than what researchers have reported in the U.S., the study authors note in their paper, published online Dec. 21 in Cancer.
“I am proud about the low rate of recalls we have in Norway and Europe – and hope we can keep it that low for the future,” said senior author Solveig Hofvind, PhD, head of BreastScreen Norway, a nationwide screening program that invites women aged 50 to 69 to mammographic screening every other year.
“The double reading in Europe is probably the main reason for the lower rate in Europe compared to the U.S., where single reading is used,” she said in an interview.
Until now, Dr. Hofvind and her colleagues say, no studies have been performed using exclusively empirical data to describe the cumulative risk of experiencing a false positive screening result in Europe because of the need for long-term follow-up and complete data registration.
For their study, the researchers turned to the Cancer Registry of Norway, which administers BreastScreen Norway. They focused on data from 1995 to 2019 on women aged 50 to 69 years who had attended one or more screening rounds and could potentially attend all 10 screening examinations over the 20-year period.
Women were excluded if they were diagnosed with breast cancer before attending screening, participated in interventional research, self-referred for screening, were recalled due to self-reported symptoms or technically inadequate mammograms, or declined follow-up after a positive screen.
Among more than 421,000 women who underwent nearly 1.9 million screening examinations, 11.3% experienced at least one false positive result and 3.3% experienced at least one false positive involving an invasive procedure, such as fine-needle aspiration cytology, core-needle biopsy, or open biopsy.
The cumulative risk of experiencing a first false positive screen was 18.0% and that of experiencing a false positive that involved an invasive procedure was 5.01%. Adjusting for irregular attendance, age at screening, or the number of screens attended had little effect on the estimates.
The results closely match earlier findings from Norway that have been based on assumptions rather than exclusively empirical data. However, these findings differ from results reported in U.S. studies, which have relied largely on data from the Breast Cancer Surveillance Consortium, the researchers say.
“The latter have indicated that, for women who initiate biennial screening at the age of 50 years, the cumulative risk after 10 years is 42% for experiencing at least one false-positive screening result and 6.4% for experiencing at least one false-positive screening result involving an invasive procedure,” Dr. Hofvind and her colleagues write.
Several principal investigators with the Breast Cancer Surveillance Consortium did not respond or were unavailable for comment when contacted by this news organization.
However, the study authors highlighted several factors that could help explain the discrepancy between the U.S. and European results.
In addition to double mammogram reading, “European guidelines recommend that breast radiologists read 3,500 to 11,000 mammograms annually, whereas 960 every 2 years are required by the U.S. Mammography Quality Standards Act,” the researchers note. They also point out that previous screening mammograms are readily available in Norway, whereas this is not always the case in the U.S.
“False-positive screening results are a part of the screening for breast cancer – and the women need to be informed about the risk,” Dr. Hofvind concluded. “The screening programs should aim to keep the rate as low as possible for the women [given] the costs.”
The study was supported by the Dam Foundation via the Norwegian Breast Cancer Society.
A version of this article first appeared on Medscape.com.
Nearly 1 in 5 women who receive the recommended 10 biennial screening rounds for breast cancer in Norway will get a false positive result, and 1 in 20 women will receive a false positive result that leads to an invasive procedure, a new analysis shows.
While the risk may seem high, it is actually much lower than what researchers have reported in the U.S., the study authors note in their paper, published online Dec. 21 in Cancer.
“I am proud about the low rate of recalls we have in Norway and Europe – and hope we can keep it that low for the future,” said senior author Solveig Hofvind, PhD, head of BreastScreen Norway, a nationwide screening program that invites women aged 50 to 69 to mammographic screening every other year.
“The double reading in Europe is probably the main reason for the lower rate in Europe compared to the U.S., where single reading is used,” she said in an interview.
Until now, Dr. Hofvind and her colleagues say, no studies have been performed using exclusively empirical data to describe the cumulative risk of experiencing a false positive screening result in Europe because of the need for long-term follow-up and complete data registration.
For their study, the researchers turned to the Cancer Registry of Norway, which administers BreastScreen Norway. They focused on data from 1995 to 2019 on women aged 50 to 69 years who had attended one or more screening rounds and could potentially attend all 10 screening examinations over the 20-year period.
Women were excluded if they were diagnosed with breast cancer before attending screening, participated in interventional research, self-referred for screening, were recalled due to self-reported symptoms or technically inadequate mammograms, or declined follow-up after a positive screen.
Among more than 421,000 women who underwent nearly 1.9 million screening examinations, 11.3% experienced at least one false positive result and 3.3% experienced at least one false positive involving an invasive procedure, such as fine-needle aspiration cytology, core-needle biopsy, or open biopsy.
The cumulative risk of experiencing a first false positive screen was 18.0% and that of experiencing a false positive that involved an invasive procedure was 5.01%. Adjusting for irregular attendance, age at screening, or the number of screens attended had little effect on the estimates.
The results closely match earlier findings from Norway that have been based on assumptions rather than exclusively empirical data. However, these findings differ from results reported in U.S. studies, which have relied largely on data from the Breast Cancer Surveillance Consortium, the researchers say.
“The latter have indicated that, for women who initiate biennial screening at the age of 50 years, the cumulative risk after 10 years is 42% for experiencing at least one false-positive screening result and 6.4% for experiencing at least one false-positive screening result involving an invasive procedure,” Dr. Hofvind and her colleagues write.
Several principal investigators with the Breast Cancer Surveillance Consortium did not respond or were unavailable for comment when contacted by this news organization.
However, the study authors highlighted several factors that could help explain the discrepancy between the U.S. and European results.
In addition to double mammogram reading, “European guidelines recommend that breast radiologists read 3,500 to 11,000 mammograms annually, whereas 960 every 2 years are required by the U.S. Mammography Quality Standards Act,” the researchers note. They also point out that previous screening mammograms are readily available in Norway, whereas this is not always the case in the U.S.
“False-positive screening results are a part of the screening for breast cancer – and the women need to be informed about the risk,” Dr. Hofvind concluded. “The screening programs should aim to keep the rate as low as possible for the women [given] the costs.”
The study was supported by the Dam Foundation via the Norwegian Breast Cancer Society.
A version of this article first appeared on Medscape.com.
Responding to the Pandemic: How is the VA doing?
The VA’s Coronavirus Disease 2019 Response Report is now in its third iteration as the pandemic continues. On the bright side, as Steven Lieberman, MD, deputy under secretary for health at the US Department of Veterans Affairs (VA), writes in the report’s introduction, “we have learned a great deal about mounting a national response to a public health crisis.”
“Annex B” covers January 1, 2021 to July 31, 2021, building on the 2 previous reports. All 3 have sought to capture and share lessons learned, with updated information on vaccination, elder care, health equity, mental health, health care ethics, preparedness, and other topics.
As the pandemic evolved, so did the VA efforts to cope with it. This iteration, for instance, deals with details of the campaign that vaccinated more than 2.5 million people “while sustaining all other aspects of the pandemic response and veteran health services,” and how the VA implemented a vaccine mandate for all VA employees in health care roles—the first federal agency to do so. In addition to vaccinating veterans, the Strengthening and Amplifying Vaccination Efforts to Locally Immunize All Veterans and Every Spouse (SAVE LIVES) Act led to nearly 80,000 other vaccinations among families, caregivers, and veterans who do not use VHA services.
The VA also conducted extensive COVID-19 testing, processing as many as 70,000 to 90,000 tests per week. It enhanced telehealth services to reach home-based and rural veterans, for an almost 2,500% increase in home-based primary care. Recognizing the added stress the pandemic put on people at risk for suicide, the VHA used predictive analytic tools specific to veterans with COVID-19 and monitored “high-risk flags,” using them to identify veterans for tailored outreach.
The response also included carrying out 158 Federal Emergency Management Agency Fourth Mission assignments. The report highlights the contributions of the more than 1,600 Veterans Health Administration (VHA) employees who volunteered to deploy across the country, often multiple times.
In addition to active response, more than 300 studies on COVID-19 have been published by VA researchers.
The current status report discusses how to expand what worked and to improve what did not. For instance, one unsurprising finding was that “the sustained pandemic response has imposed stress on the workforce, most evident in the nursing workforce.” The recommendation: Develop a comprehensive strategy with metrics and actions to monitor and mitigate stress on the health care workforce, facilitate wellness, and enhance retention.
The finding that VHA has demonstrated that telehealth usage for care to elderly veterans is “beneficial and feasible with the right technical support” led to recommendations for expanded research to identify effective COVID-19 prevention and intervention measures for elderly veterans residing at home or in long-term care facilities.
The research found that VHA processes for protecting community living center (CLC) residents during the pandemic “have succeeded in keeping rates of CLC-onset COVID-19 at the same rate as for the population of enrolled veterans over 65,” the report says. The recommendation based on that finding is to develop an information system to facilitate monitoring of state-run veterans homes for indicators of infectious disease risk, combining periodic assessment results with epidemiologic community data.
However, the report also acknowledges unexpected detours or blocks. “Planning for the mass vaccination campaign was highly effective, but did not anticipate the complexity of interagency support.” And “[t[he inability to access state vaccination data left VHA with an incomplete picture of the vaccination status of enrolled veterans.” In response, the VA recommends incorporating interagency support into planning templates and pursuing legislative action to enable the VA to obtain vaccination data from states.
Overall, the report gives the VA high marks for managing a “well-coordinated response” to an overwhelming crisis. But the lessons are not over.
“As we continue to address the pandemic and as new variants arise,” Dr. Lieberman said in comments, “it is clear that continuous learning and improvement are essential to a successful COVID-19 response. We will continue to update this report to document our efforts so veterans, doctors, and the public can understand and learn from what we’ve discovered to better serve our veterans and communities.” Stay tuned for Annex C.
The VA’s Coronavirus Disease 2019 Response Report is now in its third iteration as the pandemic continues. On the bright side, as Steven Lieberman, MD, deputy under secretary for health at the US Department of Veterans Affairs (VA), writes in the report’s introduction, “we have learned a great deal about mounting a national response to a public health crisis.”
“Annex B” covers January 1, 2021 to July 31, 2021, building on the 2 previous reports. All 3 have sought to capture and share lessons learned, with updated information on vaccination, elder care, health equity, mental health, health care ethics, preparedness, and other topics.
As the pandemic evolved, so did the VA efforts to cope with it. This iteration, for instance, deals with details of the campaign that vaccinated more than 2.5 million people “while sustaining all other aspects of the pandemic response and veteran health services,” and how the VA implemented a vaccine mandate for all VA employees in health care roles—the first federal agency to do so. In addition to vaccinating veterans, the Strengthening and Amplifying Vaccination Efforts to Locally Immunize All Veterans and Every Spouse (SAVE LIVES) Act led to nearly 80,000 other vaccinations among families, caregivers, and veterans who do not use VHA services.
The VA also conducted extensive COVID-19 testing, processing as many as 70,000 to 90,000 tests per week. It enhanced telehealth services to reach home-based and rural veterans, for an almost 2,500% increase in home-based primary care. Recognizing the added stress the pandemic put on people at risk for suicide, the VHA used predictive analytic tools specific to veterans with COVID-19 and monitored “high-risk flags,” using them to identify veterans for tailored outreach.
The response also included carrying out 158 Federal Emergency Management Agency Fourth Mission assignments. The report highlights the contributions of the more than 1,600 Veterans Health Administration (VHA) employees who volunteered to deploy across the country, often multiple times.
In addition to active response, more than 300 studies on COVID-19 have been published by VA researchers.
The current status report discusses how to expand what worked and to improve what did not. For instance, one unsurprising finding was that “the sustained pandemic response has imposed stress on the workforce, most evident in the nursing workforce.” The recommendation: Develop a comprehensive strategy with metrics and actions to monitor and mitigate stress on the health care workforce, facilitate wellness, and enhance retention.
The finding that VHA has demonstrated that telehealth usage for care to elderly veterans is “beneficial and feasible with the right technical support” led to recommendations for expanded research to identify effective COVID-19 prevention and intervention measures for elderly veterans residing at home or in long-term care facilities.
The research found that VHA processes for protecting community living center (CLC) residents during the pandemic “have succeeded in keeping rates of CLC-onset COVID-19 at the same rate as for the population of enrolled veterans over 65,” the report says. The recommendation based on that finding is to develop an information system to facilitate monitoring of state-run veterans homes for indicators of infectious disease risk, combining periodic assessment results with epidemiologic community data.
However, the report also acknowledges unexpected detours or blocks. “Planning for the mass vaccination campaign was highly effective, but did not anticipate the complexity of interagency support.” And “[t[he inability to access state vaccination data left VHA with an incomplete picture of the vaccination status of enrolled veterans.” In response, the VA recommends incorporating interagency support into planning templates and pursuing legislative action to enable the VA to obtain vaccination data from states.
Overall, the report gives the VA high marks for managing a “well-coordinated response” to an overwhelming crisis. But the lessons are not over.
“As we continue to address the pandemic and as new variants arise,” Dr. Lieberman said in comments, “it is clear that continuous learning and improvement are essential to a successful COVID-19 response. We will continue to update this report to document our efforts so veterans, doctors, and the public can understand and learn from what we’ve discovered to better serve our veterans and communities.” Stay tuned for Annex C.
The VA’s Coronavirus Disease 2019 Response Report is now in its third iteration as the pandemic continues. On the bright side, as Steven Lieberman, MD, deputy under secretary for health at the US Department of Veterans Affairs (VA), writes in the report’s introduction, “we have learned a great deal about mounting a national response to a public health crisis.”
“Annex B” covers January 1, 2021 to July 31, 2021, building on the 2 previous reports. All 3 have sought to capture and share lessons learned, with updated information on vaccination, elder care, health equity, mental health, health care ethics, preparedness, and other topics.
As the pandemic evolved, so did the VA efforts to cope with it. This iteration, for instance, deals with details of the campaign that vaccinated more than 2.5 million people “while sustaining all other aspects of the pandemic response and veteran health services,” and how the VA implemented a vaccine mandate for all VA employees in health care roles—the first federal agency to do so. In addition to vaccinating veterans, the Strengthening and Amplifying Vaccination Efforts to Locally Immunize All Veterans and Every Spouse (SAVE LIVES) Act led to nearly 80,000 other vaccinations among families, caregivers, and veterans who do not use VHA services.
The VA also conducted extensive COVID-19 testing, processing as many as 70,000 to 90,000 tests per week. It enhanced telehealth services to reach home-based and rural veterans, for an almost 2,500% increase in home-based primary care. Recognizing the added stress the pandemic put on people at risk for suicide, the VHA used predictive analytic tools specific to veterans with COVID-19 and monitored “high-risk flags,” using them to identify veterans for tailored outreach.
The response also included carrying out 158 Federal Emergency Management Agency Fourth Mission assignments. The report highlights the contributions of the more than 1,600 Veterans Health Administration (VHA) employees who volunteered to deploy across the country, often multiple times.
In addition to active response, more than 300 studies on COVID-19 have been published by VA researchers.
The current status report discusses how to expand what worked and to improve what did not. For instance, one unsurprising finding was that “the sustained pandemic response has imposed stress on the workforce, most evident in the nursing workforce.” The recommendation: Develop a comprehensive strategy with metrics and actions to monitor and mitigate stress on the health care workforce, facilitate wellness, and enhance retention.
The finding that VHA has demonstrated that telehealth usage for care to elderly veterans is “beneficial and feasible with the right technical support” led to recommendations for expanded research to identify effective COVID-19 prevention and intervention measures for elderly veterans residing at home or in long-term care facilities.
The research found that VHA processes for protecting community living center (CLC) residents during the pandemic “have succeeded in keeping rates of CLC-onset COVID-19 at the same rate as for the population of enrolled veterans over 65,” the report says. The recommendation based on that finding is to develop an information system to facilitate monitoring of state-run veterans homes for indicators of infectious disease risk, combining periodic assessment results with epidemiologic community data.
However, the report also acknowledges unexpected detours or blocks. “Planning for the mass vaccination campaign was highly effective, but did not anticipate the complexity of interagency support.” And “[t[he inability to access state vaccination data left VHA with an incomplete picture of the vaccination status of enrolled veterans.” In response, the VA recommends incorporating interagency support into planning templates and pursuing legislative action to enable the VA to obtain vaccination data from states.
Overall, the report gives the VA high marks for managing a “well-coordinated response” to an overwhelming crisis. But the lessons are not over.
“As we continue to address the pandemic and as new variants arise,” Dr. Lieberman said in comments, “it is clear that continuous learning and improvement are essential to a successful COVID-19 response. We will continue to update this report to document our efforts so veterans, doctors, and the public can understand and learn from what we’ve discovered to better serve our veterans and communities.” Stay tuned for Annex C.