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Less than a third of Americans aware of cancer risk from alcohol
The new findings, from a nationally representative survey that included responses from 3,865 adults, show a low awareness of the cancer risk from alcohol, and also that the risk varies by type of drink. Just under a third (31.2%) of respondents thought that consuming liquor/spirits was associated with a risk of cancer, but this fell to 24.9% for drinking beer and even further, to 20.3%, for drinking wine.
In fact, some respondents though the opposite – that drinking alcohol has health benefits; 10.3% of respondents thought that drinking wine was associated with a decreased cancer risk, while 2.25% thought the same for drinking beer, and 1.7% thought that for drinking liquor.
Most U.S. adults (> 50%) reported not knowing how these beverages affected cancer risk, the authors report.
“This study’s findings underscore the need to develop interventions for educating the public about the cancer risks of alcohol use, particularly in the prevailing context of national dialogue about the purported heart health benefits of wine,” commented senior author William M. P. Klein, PhD, associate director of the National Cancer Institute’s Behavioral Research Program, in a statement.
“All types of alcoholic beverages, including wine, increase cancer risk,” Dr. Klein said.
The findings were published online in Cancer Epidemiology, Biomarkers & Prevention.
The results echo the findings of a previous national survey that also found that the majority of Americans are not aware that alcohol consumption is associated with an increased risk of developing a variety of cancers.
In contrast, within the scientific community, there is long-standing and increasing awareness of alcohol consumption as a leading modifiable risk factor for cancer, and there is a growing movement calling for more public health awareness of the link.
Recently, there has been some public support for adding written warnings about the cancer risk from alcohol. A Citizen Petition was filed in 2021, and in August 2022, The New England Journal of Medicine issued a call for new labeling.
Several cancer organizations are petitioning for warnings to be added to alcoholic beverages. The petition is supported by the American Society of Clinical Oncology, the American Institute for Cancer Research, and Breast Cancer Prevention Partners, all in collaboration with several public health organizations. Proposed labeling would read: “WARNING: According to the Surgeon General, consumption of alcoholic beverages can cause cancer, including breast and colon cancers.”
Dr. Klein and colleagues suggest that public health interventions, including mass media campaigns, cancer warning labels, and patient-provider communications, could help disseminate information about cancer and alcohol. “Educating the public about how alcohol increases cancer risk will not only empower consumers to make more informed decisions but may also prevent and reduce excessive alcohol use, as well as cancer morbidity and mortality,” Dr. Klein said.
The study was supported by the Division of Cancer Control and Population Sciences at the National Cancer Institute. The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The new findings, from a nationally representative survey that included responses from 3,865 adults, show a low awareness of the cancer risk from alcohol, and also that the risk varies by type of drink. Just under a third (31.2%) of respondents thought that consuming liquor/spirits was associated with a risk of cancer, but this fell to 24.9% for drinking beer and even further, to 20.3%, for drinking wine.
In fact, some respondents though the opposite – that drinking alcohol has health benefits; 10.3% of respondents thought that drinking wine was associated with a decreased cancer risk, while 2.25% thought the same for drinking beer, and 1.7% thought that for drinking liquor.
Most U.S. adults (> 50%) reported not knowing how these beverages affected cancer risk, the authors report.
“This study’s findings underscore the need to develop interventions for educating the public about the cancer risks of alcohol use, particularly in the prevailing context of national dialogue about the purported heart health benefits of wine,” commented senior author William M. P. Klein, PhD, associate director of the National Cancer Institute’s Behavioral Research Program, in a statement.
“All types of alcoholic beverages, including wine, increase cancer risk,” Dr. Klein said.
The findings were published online in Cancer Epidemiology, Biomarkers & Prevention.
The results echo the findings of a previous national survey that also found that the majority of Americans are not aware that alcohol consumption is associated with an increased risk of developing a variety of cancers.
In contrast, within the scientific community, there is long-standing and increasing awareness of alcohol consumption as a leading modifiable risk factor for cancer, and there is a growing movement calling for more public health awareness of the link.
Recently, there has been some public support for adding written warnings about the cancer risk from alcohol. A Citizen Petition was filed in 2021, and in August 2022, The New England Journal of Medicine issued a call for new labeling.
Several cancer organizations are petitioning for warnings to be added to alcoholic beverages. The petition is supported by the American Society of Clinical Oncology, the American Institute for Cancer Research, and Breast Cancer Prevention Partners, all in collaboration with several public health organizations. Proposed labeling would read: “WARNING: According to the Surgeon General, consumption of alcoholic beverages can cause cancer, including breast and colon cancers.”
Dr. Klein and colleagues suggest that public health interventions, including mass media campaigns, cancer warning labels, and patient-provider communications, could help disseminate information about cancer and alcohol. “Educating the public about how alcohol increases cancer risk will not only empower consumers to make more informed decisions but may also prevent and reduce excessive alcohol use, as well as cancer morbidity and mortality,” Dr. Klein said.
The study was supported by the Division of Cancer Control and Population Sciences at the National Cancer Institute. The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The new findings, from a nationally representative survey that included responses from 3,865 adults, show a low awareness of the cancer risk from alcohol, and also that the risk varies by type of drink. Just under a third (31.2%) of respondents thought that consuming liquor/spirits was associated with a risk of cancer, but this fell to 24.9% for drinking beer and even further, to 20.3%, for drinking wine.
In fact, some respondents though the opposite – that drinking alcohol has health benefits; 10.3% of respondents thought that drinking wine was associated with a decreased cancer risk, while 2.25% thought the same for drinking beer, and 1.7% thought that for drinking liquor.
Most U.S. adults (> 50%) reported not knowing how these beverages affected cancer risk, the authors report.
“This study’s findings underscore the need to develop interventions for educating the public about the cancer risks of alcohol use, particularly in the prevailing context of national dialogue about the purported heart health benefits of wine,” commented senior author William M. P. Klein, PhD, associate director of the National Cancer Institute’s Behavioral Research Program, in a statement.
“All types of alcoholic beverages, including wine, increase cancer risk,” Dr. Klein said.
The findings were published online in Cancer Epidemiology, Biomarkers & Prevention.
The results echo the findings of a previous national survey that also found that the majority of Americans are not aware that alcohol consumption is associated with an increased risk of developing a variety of cancers.
In contrast, within the scientific community, there is long-standing and increasing awareness of alcohol consumption as a leading modifiable risk factor for cancer, and there is a growing movement calling for more public health awareness of the link.
Recently, there has been some public support for adding written warnings about the cancer risk from alcohol. A Citizen Petition was filed in 2021, and in August 2022, The New England Journal of Medicine issued a call for new labeling.
Several cancer organizations are petitioning for warnings to be added to alcoholic beverages. The petition is supported by the American Society of Clinical Oncology, the American Institute for Cancer Research, and Breast Cancer Prevention Partners, all in collaboration with several public health organizations. Proposed labeling would read: “WARNING: According to the Surgeon General, consumption of alcoholic beverages can cause cancer, including breast and colon cancers.”
Dr. Klein and colleagues suggest that public health interventions, including mass media campaigns, cancer warning labels, and patient-provider communications, could help disseminate information about cancer and alcohol. “Educating the public about how alcohol increases cancer risk will not only empower consumers to make more informed decisions but may also prevent and reduce excessive alcohol use, as well as cancer morbidity and mortality,” Dr. Klein said.
The study was supported by the Division of Cancer Control and Population Sciences at the National Cancer Institute. The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM CANCER EPIDEMIOLOGY, BIOMARKERS & PREVENTION
Diabetes decision tool yields ‘modest’ benefit in low-resource clinics
a randomized trial in China showed.
The tool required clinicians to enter patient data into a computer in order to generate individualized treatment recommendations, adding to their administrative burdens. It also couldn’t tackle patients’ problems with access and affordability of medications.
Nevertheless, the model could curtail physician burnout and improve the quality of care in primary care clinics with limited resources, the researchers said in a paper published in the Annals of Internal Medicine.
They concluded that the findings support “widespread adoption” of the model in China and other low- or middle-income countries where diabetes is on the rise.
Co–principal investigator Jiang He, MD, PhD, chair of epidemiology at Tulane University, New Orleans, said the findings could apply to federally qualified health care (FQHC) clinics that treat underserved patients in the United States.
“At many FQHC clinics, nurse practitioners have to take care of patients with multiple chronic disease conditions. Team-based care with a computerized clinical decision support system will help them and improve patient care,” Dr. He said.
Small improvements
To conduct the trial, called Diabetes Complication Control in Community Clinics (D4C), Dr. He and colleagues randomly assigned 19 out of the 38 community health centers in Xiamen, China, to have a clinical decision support tool installed on the computers of primary care physicians and health coaches.
Starting in October 2016 the researchers recruited 11,132 patients aged 50 and older with uncontrolled diabetes and at least one comorbid condition, with 5,475 patients receiving team-based care with the CDSS and the remainder receiving team-based care alone.
The CDSS generated individualized risk factor summaries and treatment recommendations, including prescriptions based on Chinese and U.S. clinical guidelines. It incorporated data on patients’ insurance plans and local availability of drugs.
At all centers, primary care physicians received training in managing glycemia, blood pressure, and lipids. Nurses were certified as health coaches after receiving training on nutrition, lifestyle changes, and medication adherence. Patients met with their coaches for half an hour every 3 months, and diabetes specialists visited each clinic monthly for team meetings and consultations.
After 18 months, patients undergoing team-based care alone lowered their hemoglobin A1c by 0.6 percentage points (95% confidence interval, –0.7 to –0.5 percentage points), LDL cholesterol by 12.5 mg/dL (95% CI, –13.6 to –11.3 mg/dL), and systolic blood pressure by 7.5 mm Hg (95% CI, –8.4 to –6.6 mm Hg).
The group whose care teams used the CDSS further reduced A1c by 0.2 percentage points (95% CI, –0.3 to –0.1 percentage points), LDL cholesterol by 6.5 mg/dL (95% CI, –8.3 to -4.6 mg/dL), and blood pressure by 1.5 mm Hg (95% CI, –2.8 to –0.3 mm Hg).
All-cause mortality did not differ between the groups. Serious adverse events occurred in 9.1% of the CDSS group, compared with 10.9% of the group whose care team did not use the CDSS.
Addressing social needs
Experts who were not involved in the trial said the marginal impact of the CDSS was no surprise given the mixed results of such tools in previous studies.
However, the lackluster result “might be a shock to people investing a lot in clinical decision support,” said Elbert Huang, MD, MPH, director of the Center for Chronic Disease Research and Policy at the University of Chicago.
Anne Peters, MD, a professor of medicine at the University of Southern California, Los Angeles, said the administrative burden of entering each patient’s data into the system would slow down care and frustrate clinicians. “The system has to be smarter than this.”
On the other hand, the findings of the D4C trial align with other research showing that team-based care strategies are effective for diabetes management.
Dr. Huang noted that there is a “well-established history” of diabetes quality improvement programs, health coaches, buddy programs, and community health worker programs. He added that the new findings “might help to remind everyone of the importance of these programs, which are not always well supported.”
“The bottom line of the paper might be that investing in patient engagement programs might get us 90% of the way to our goal of improving diabetes care,” Dr. Huang said.
Still, Dr. Peters said the portion of patients in the trial who benefited from team-based care seemed “disturbingly low.” Just 16.9% of patients who received team-based care and CDSS and 13% of those who received team-based care alone improved in all three measures. “This system doesn’t get you to where you want to be by a long shot.”
She added that a team-based approach, particularly the use of health coaches, would be a “huge improvement” over fragmented care provided in much of the U.S. safety-net system.
Another team approach
Many systems are striving to improve diabetes management in response to payment incentives, Dr. Huang said.
In a separate retrospective analysis, published in Annals of Family Medicine, researchers at the Mayo Clinic, Rochester, Minn., reported quality improvement gains among primary care practices that adopted a team-based model called Enhanced Primary Care Diabetes (EPCD). The model deployed a range of strategies, such as empowering nurses to engage with patients outside of scheduled office visits and including pharmacists on care teams.
Mayo’s approach did not specifically target underserved populations. Rather, researchers evaluated the model’s impact on about 17,000 patients treated at 32 Mayo internal medicine and family medicine practices of varying sizes, resources, and community settings.
Among staff clinician practices using the EPCD model improved patients’ scores on a composite quality measure called D5, which incorporates glycemic control, blood pressure control, low-density lipoprotein control, tobacco abstinence, and aspirin use.
Following implementation, the portion of patients in those practices meeting the D5 indicator increased from 42.9% to 45.0% (incident rate ratio, 1.005; P = .001).
Meanwhile, the portion of patients meeting the indicator increased from 38.9% to 42.0% (IRR, 1.011; P = .003) at resident physician practices that used the EPCD model and decreased from 36.2% to 35.5% (IRR, 0.994; P < .001) at staff clinician practices that did not use the model.
In contrast to the team-based approach used in China, the EPCD protocol “is very complex, and it will be difficult to implement in low-resource settings,” Dr. He said.
The D4C trial was funded by the Xiamen Municipal Health Commission. The Mayo study was funded by a National Institutes of Diabetes and Digestive and Kidney Diseases grant. Dr. He, Dr. Peters, and Dr. Huang reported no relevant financial interests.
a randomized trial in China showed.
The tool required clinicians to enter patient data into a computer in order to generate individualized treatment recommendations, adding to their administrative burdens. It also couldn’t tackle patients’ problems with access and affordability of medications.
Nevertheless, the model could curtail physician burnout and improve the quality of care in primary care clinics with limited resources, the researchers said in a paper published in the Annals of Internal Medicine.
They concluded that the findings support “widespread adoption” of the model in China and other low- or middle-income countries where diabetes is on the rise.
Co–principal investigator Jiang He, MD, PhD, chair of epidemiology at Tulane University, New Orleans, said the findings could apply to federally qualified health care (FQHC) clinics that treat underserved patients in the United States.
“At many FQHC clinics, nurse practitioners have to take care of patients with multiple chronic disease conditions. Team-based care with a computerized clinical decision support system will help them and improve patient care,” Dr. He said.
Small improvements
To conduct the trial, called Diabetes Complication Control in Community Clinics (D4C), Dr. He and colleagues randomly assigned 19 out of the 38 community health centers in Xiamen, China, to have a clinical decision support tool installed on the computers of primary care physicians and health coaches.
Starting in October 2016 the researchers recruited 11,132 patients aged 50 and older with uncontrolled diabetes and at least one comorbid condition, with 5,475 patients receiving team-based care with the CDSS and the remainder receiving team-based care alone.
The CDSS generated individualized risk factor summaries and treatment recommendations, including prescriptions based on Chinese and U.S. clinical guidelines. It incorporated data on patients’ insurance plans and local availability of drugs.
At all centers, primary care physicians received training in managing glycemia, blood pressure, and lipids. Nurses were certified as health coaches after receiving training on nutrition, lifestyle changes, and medication adherence. Patients met with their coaches for half an hour every 3 months, and diabetes specialists visited each clinic monthly for team meetings and consultations.
After 18 months, patients undergoing team-based care alone lowered their hemoglobin A1c by 0.6 percentage points (95% confidence interval, –0.7 to –0.5 percentage points), LDL cholesterol by 12.5 mg/dL (95% CI, –13.6 to –11.3 mg/dL), and systolic blood pressure by 7.5 mm Hg (95% CI, –8.4 to –6.6 mm Hg).
The group whose care teams used the CDSS further reduced A1c by 0.2 percentage points (95% CI, –0.3 to –0.1 percentage points), LDL cholesterol by 6.5 mg/dL (95% CI, –8.3 to -4.6 mg/dL), and blood pressure by 1.5 mm Hg (95% CI, –2.8 to –0.3 mm Hg).
All-cause mortality did not differ between the groups. Serious adverse events occurred in 9.1% of the CDSS group, compared with 10.9% of the group whose care team did not use the CDSS.
Addressing social needs
Experts who were not involved in the trial said the marginal impact of the CDSS was no surprise given the mixed results of such tools in previous studies.
However, the lackluster result “might be a shock to people investing a lot in clinical decision support,” said Elbert Huang, MD, MPH, director of the Center for Chronic Disease Research and Policy at the University of Chicago.
Anne Peters, MD, a professor of medicine at the University of Southern California, Los Angeles, said the administrative burden of entering each patient’s data into the system would slow down care and frustrate clinicians. “The system has to be smarter than this.”
On the other hand, the findings of the D4C trial align with other research showing that team-based care strategies are effective for diabetes management.
Dr. Huang noted that there is a “well-established history” of diabetes quality improvement programs, health coaches, buddy programs, and community health worker programs. He added that the new findings “might help to remind everyone of the importance of these programs, which are not always well supported.”
“The bottom line of the paper might be that investing in patient engagement programs might get us 90% of the way to our goal of improving diabetes care,” Dr. Huang said.
Still, Dr. Peters said the portion of patients in the trial who benefited from team-based care seemed “disturbingly low.” Just 16.9% of patients who received team-based care and CDSS and 13% of those who received team-based care alone improved in all three measures. “This system doesn’t get you to where you want to be by a long shot.”
She added that a team-based approach, particularly the use of health coaches, would be a “huge improvement” over fragmented care provided in much of the U.S. safety-net system.
Another team approach
Many systems are striving to improve diabetes management in response to payment incentives, Dr. Huang said.
In a separate retrospective analysis, published in Annals of Family Medicine, researchers at the Mayo Clinic, Rochester, Minn., reported quality improvement gains among primary care practices that adopted a team-based model called Enhanced Primary Care Diabetes (EPCD). The model deployed a range of strategies, such as empowering nurses to engage with patients outside of scheduled office visits and including pharmacists on care teams.
Mayo’s approach did not specifically target underserved populations. Rather, researchers evaluated the model’s impact on about 17,000 patients treated at 32 Mayo internal medicine and family medicine practices of varying sizes, resources, and community settings.
Among staff clinician practices using the EPCD model improved patients’ scores on a composite quality measure called D5, which incorporates glycemic control, blood pressure control, low-density lipoprotein control, tobacco abstinence, and aspirin use.
Following implementation, the portion of patients in those practices meeting the D5 indicator increased from 42.9% to 45.0% (incident rate ratio, 1.005; P = .001).
Meanwhile, the portion of patients meeting the indicator increased from 38.9% to 42.0% (IRR, 1.011; P = .003) at resident physician practices that used the EPCD model and decreased from 36.2% to 35.5% (IRR, 0.994; P < .001) at staff clinician practices that did not use the model.
In contrast to the team-based approach used in China, the EPCD protocol “is very complex, and it will be difficult to implement in low-resource settings,” Dr. He said.
The D4C trial was funded by the Xiamen Municipal Health Commission. The Mayo study was funded by a National Institutes of Diabetes and Digestive and Kidney Diseases grant. Dr. He, Dr. Peters, and Dr. Huang reported no relevant financial interests.
a randomized trial in China showed.
The tool required clinicians to enter patient data into a computer in order to generate individualized treatment recommendations, adding to their administrative burdens. It also couldn’t tackle patients’ problems with access and affordability of medications.
Nevertheless, the model could curtail physician burnout and improve the quality of care in primary care clinics with limited resources, the researchers said in a paper published in the Annals of Internal Medicine.
They concluded that the findings support “widespread adoption” of the model in China and other low- or middle-income countries where diabetes is on the rise.
Co–principal investigator Jiang He, MD, PhD, chair of epidemiology at Tulane University, New Orleans, said the findings could apply to federally qualified health care (FQHC) clinics that treat underserved patients in the United States.
“At many FQHC clinics, nurse practitioners have to take care of patients with multiple chronic disease conditions. Team-based care with a computerized clinical decision support system will help them and improve patient care,” Dr. He said.
Small improvements
To conduct the trial, called Diabetes Complication Control in Community Clinics (D4C), Dr. He and colleagues randomly assigned 19 out of the 38 community health centers in Xiamen, China, to have a clinical decision support tool installed on the computers of primary care physicians and health coaches.
Starting in October 2016 the researchers recruited 11,132 patients aged 50 and older with uncontrolled diabetes and at least one comorbid condition, with 5,475 patients receiving team-based care with the CDSS and the remainder receiving team-based care alone.
The CDSS generated individualized risk factor summaries and treatment recommendations, including prescriptions based on Chinese and U.S. clinical guidelines. It incorporated data on patients’ insurance plans and local availability of drugs.
At all centers, primary care physicians received training in managing glycemia, blood pressure, and lipids. Nurses were certified as health coaches after receiving training on nutrition, lifestyle changes, and medication adherence. Patients met with their coaches for half an hour every 3 months, and diabetes specialists visited each clinic monthly for team meetings and consultations.
After 18 months, patients undergoing team-based care alone lowered their hemoglobin A1c by 0.6 percentage points (95% confidence interval, –0.7 to –0.5 percentage points), LDL cholesterol by 12.5 mg/dL (95% CI, –13.6 to –11.3 mg/dL), and systolic blood pressure by 7.5 mm Hg (95% CI, –8.4 to –6.6 mm Hg).
The group whose care teams used the CDSS further reduced A1c by 0.2 percentage points (95% CI, –0.3 to –0.1 percentage points), LDL cholesterol by 6.5 mg/dL (95% CI, –8.3 to -4.6 mg/dL), and blood pressure by 1.5 mm Hg (95% CI, –2.8 to –0.3 mm Hg).
All-cause mortality did not differ between the groups. Serious adverse events occurred in 9.1% of the CDSS group, compared with 10.9% of the group whose care team did not use the CDSS.
Addressing social needs
Experts who were not involved in the trial said the marginal impact of the CDSS was no surprise given the mixed results of such tools in previous studies.
However, the lackluster result “might be a shock to people investing a lot in clinical decision support,” said Elbert Huang, MD, MPH, director of the Center for Chronic Disease Research and Policy at the University of Chicago.
Anne Peters, MD, a professor of medicine at the University of Southern California, Los Angeles, said the administrative burden of entering each patient’s data into the system would slow down care and frustrate clinicians. “The system has to be smarter than this.”
On the other hand, the findings of the D4C trial align with other research showing that team-based care strategies are effective for diabetes management.
Dr. Huang noted that there is a “well-established history” of diabetes quality improvement programs, health coaches, buddy programs, and community health worker programs. He added that the new findings “might help to remind everyone of the importance of these programs, which are not always well supported.”
“The bottom line of the paper might be that investing in patient engagement programs might get us 90% of the way to our goal of improving diabetes care,” Dr. Huang said.
Still, Dr. Peters said the portion of patients in the trial who benefited from team-based care seemed “disturbingly low.” Just 16.9% of patients who received team-based care and CDSS and 13% of those who received team-based care alone improved in all three measures. “This system doesn’t get you to where you want to be by a long shot.”
She added that a team-based approach, particularly the use of health coaches, would be a “huge improvement” over fragmented care provided in much of the U.S. safety-net system.
Another team approach
Many systems are striving to improve diabetes management in response to payment incentives, Dr. Huang said.
In a separate retrospective analysis, published in Annals of Family Medicine, researchers at the Mayo Clinic, Rochester, Minn., reported quality improvement gains among primary care practices that adopted a team-based model called Enhanced Primary Care Diabetes (EPCD). The model deployed a range of strategies, such as empowering nurses to engage with patients outside of scheduled office visits and including pharmacists on care teams.
Mayo’s approach did not specifically target underserved populations. Rather, researchers evaluated the model’s impact on about 17,000 patients treated at 32 Mayo internal medicine and family medicine practices of varying sizes, resources, and community settings.
Among staff clinician practices using the EPCD model improved patients’ scores on a composite quality measure called D5, which incorporates glycemic control, blood pressure control, low-density lipoprotein control, tobacco abstinence, and aspirin use.
Following implementation, the portion of patients in those practices meeting the D5 indicator increased from 42.9% to 45.0% (incident rate ratio, 1.005; P = .001).
Meanwhile, the portion of patients meeting the indicator increased from 38.9% to 42.0% (IRR, 1.011; P = .003) at resident physician practices that used the EPCD model and decreased from 36.2% to 35.5% (IRR, 0.994; P < .001) at staff clinician practices that did not use the model.
In contrast to the team-based approach used in China, the EPCD protocol “is very complex, and it will be difficult to implement in low-resource settings,” Dr. He said.
The D4C trial was funded by the Xiamen Municipal Health Commission. The Mayo study was funded by a National Institutes of Diabetes and Digestive and Kidney Diseases grant. Dr. He, Dr. Peters, and Dr. Huang reported no relevant financial interests.
FROM ANNALS OF INTERNAL MEDICINE
Study comparing surgical and N95 masks sparks concern
The study’s senior author is John Conly, MD, an infectious disease specialist and professor at the University of Calgary (Alta.), and Alberta Health Services. The findings are not consistent with those of many other studies on this topic.
Commenting about Dr. Conly’s study, Eric Topol, MD, editor-in-chief of Medscape, wrote: “It’s woefully underpowered but ruled out a doubling of hazard for use of medical masks.”
The study, which was partially funded by the World Health Organization, was published online in Annals of Internal Medicine.
This is not the first time that Dr. Conly, who also advises the WHO, has been the subject of controversy. He previously denied that COVID-19 is airborne – a position that is contradicted by strong evidence. In 2021, Dr. Conly made headlines with his controversial claim that N95 respirators can cause harms, including oxygen depletion and carbon dioxide retention.
A detailed examination by the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota, Minneapolis, pointed out numerous scientific flaws in the study, including inconsistent use of both types of masks. The study also examined health care workers in four very different countries (Canada, Israel, Egypt, and Pakistan) during different periods of the pandemic, which may have affected the results. Furthermore, the study did not account for vaccination status and lacked a control group. CIDRAP receives funding from 3M, which makes N95 respirators.
In a commentary published alongside the study, Roger Chou, MD, professor of medicine at Oregon Health & Science University, Portland, said that the results were “not definitive,” with “a generous noninferiority threshold” that is actually “consistent with up to a relative 70% increased risk ... which may be unacceptable to many health workers.”
Lead study author Mark Loeb, MD, professor of infectious diseases at McMaster University, Hamilton, Ont., defended the findings. “The confidence intervals around this, that is, what the possible results could be if the trial was repeated many times, range from −2.5% to 4.9%,” he told this news organization. “This means that the risk of a COVID-19 infection in those using the medical masks could have ranged from anywhere from 2.5% reduction in risk to a 4.9% increase in risk. Readers and policy makers can decide for themselves about this.”
“There is no point continuing to run underpowered, poorly designed studies that are designed to confirm existing biases,” Raina MacIntyre, PhD, professor of global biosecurity and head of the Biosecurity Program at the Kirby Institute, Sydney, said in an interview. “The new study in Annals of Internal Medicine is entirely consistent with our finding that to prevent infection, you need an N95, and it needs to be worn throughout the whole shift. A surgical mask and intermittent use of N95 are equally ineffective. This should not surprise anyone, given a surgical mask is not designed as respiratory protection but is designed to prevent splash or spray of liquid on the face. Only a respirator is designed as respiratory protection through both the seal around the face and the filter of the face piece to prevent inhalation of virus laden aerosols, but you need to wear it continually in a high-risk environment like a hospital.”
“It makes zero sense to do a randomized trial on something you can measure directly,” said Kimberly Prather, PhD, an atmospheric chemist, professor, and director of the NSF Center for Aerosol Impacts on Chemistry of the Environment at the University of California, San Diego. “In fact, many studies have shown aerosols leaking out of surgical masks. Surgical masks are designed to block large spray droplets. Aerosols (0.5-3 mcm), which have been shown to contain infectious SARS-CoV-2 virus, travel with the air flow, and escape.”
“This study ... will be used to justify policies of supplying health care workers, and perhaps patients and visitors, too, with inadequate protection,” Trish Greenhalgh, MD, professor of primary care health sciences at the University of Oxford (England), told this news organization.
“These authors have been pushing back against treating COVID as airborne for 3 years,” David Fisman, MD, an epidemiologist and infectious disease specialist at the University of Toronto, said in an interview. “So, you’ll see these folks brandishing this very flawed trial to justify continuing the infection control practices that have been so disastrous throughout the pandemic.”
The study was funded by the World Health Organization, the Canadian Institutes of Health Research, and the Juravinski Research Institute. Dr. Conly reported receiving grants from the Canadian Institutes for Health Research, Pfizer, and the WHO. Dr. Chou disclosed being a methodologist for WHO guidelines on infection prevention and control measures for COVID-19. Dr. Loeb disclosed payment for expert testimony on personal protective equipment from the government of Manitoba and the Peel District School Board. Dr. MacIntyre has led a large body of research on masks and respirators in health workers, including four randomized clinical trials. She is the author of a book, “Dark Winter: An insider’s guide to pandemics and biosecurity” (Syndey: NewSouth Publishing, 2022), which covers the history and politics of the controversies around N95 and masks. Dr. Prather reported no disclosures. Dr. Greenhalgh is a member of Independent SAGE and an unpaid adviser to the philanthropic fund Balvi. Dr. Fisman has served as a paid legal expert for the Ontario Nurses’ Association in their challenge to Directive 5, which restricted access to N95 masks in health care. He also served as a paid legal expert for the Elementary Teachers’ Federation of Ontario in its efforts to make schools safer in Ontario.
A version of this article first appeared on Medscape.com.
The study’s senior author is John Conly, MD, an infectious disease specialist and professor at the University of Calgary (Alta.), and Alberta Health Services. The findings are not consistent with those of many other studies on this topic.
Commenting about Dr. Conly’s study, Eric Topol, MD, editor-in-chief of Medscape, wrote: “It’s woefully underpowered but ruled out a doubling of hazard for use of medical masks.”
The study, which was partially funded by the World Health Organization, was published online in Annals of Internal Medicine.
This is not the first time that Dr. Conly, who also advises the WHO, has been the subject of controversy. He previously denied that COVID-19 is airborne – a position that is contradicted by strong evidence. In 2021, Dr. Conly made headlines with his controversial claim that N95 respirators can cause harms, including oxygen depletion and carbon dioxide retention.
A detailed examination by the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota, Minneapolis, pointed out numerous scientific flaws in the study, including inconsistent use of both types of masks. The study also examined health care workers in four very different countries (Canada, Israel, Egypt, and Pakistan) during different periods of the pandemic, which may have affected the results. Furthermore, the study did not account for vaccination status and lacked a control group. CIDRAP receives funding from 3M, which makes N95 respirators.
In a commentary published alongside the study, Roger Chou, MD, professor of medicine at Oregon Health & Science University, Portland, said that the results were “not definitive,” with “a generous noninferiority threshold” that is actually “consistent with up to a relative 70% increased risk ... which may be unacceptable to many health workers.”
Lead study author Mark Loeb, MD, professor of infectious diseases at McMaster University, Hamilton, Ont., defended the findings. “The confidence intervals around this, that is, what the possible results could be if the trial was repeated many times, range from −2.5% to 4.9%,” he told this news organization. “This means that the risk of a COVID-19 infection in those using the medical masks could have ranged from anywhere from 2.5% reduction in risk to a 4.9% increase in risk. Readers and policy makers can decide for themselves about this.”
“There is no point continuing to run underpowered, poorly designed studies that are designed to confirm existing biases,” Raina MacIntyre, PhD, professor of global biosecurity and head of the Biosecurity Program at the Kirby Institute, Sydney, said in an interview. “The new study in Annals of Internal Medicine is entirely consistent with our finding that to prevent infection, you need an N95, and it needs to be worn throughout the whole shift. A surgical mask and intermittent use of N95 are equally ineffective. This should not surprise anyone, given a surgical mask is not designed as respiratory protection but is designed to prevent splash or spray of liquid on the face. Only a respirator is designed as respiratory protection through both the seal around the face and the filter of the face piece to prevent inhalation of virus laden aerosols, but you need to wear it continually in a high-risk environment like a hospital.”
“It makes zero sense to do a randomized trial on something you can measure directly,” said Kimberly Prather, PhD, an atmospheric chemist, professor, and director of the NSF Center for Aerosol Impacts on Chemistry of the Environment at the University of California, San Diego. “In fact, many studies have shown aerosols leaking out of surgical masks. Surgical masks are designed to block large spray droplets. Aerosols (0.5-3 mcm), which have been shown to contain infectious SARS-CoV-2 virus, travel with the air flow, and escape.”
“This study ... will be used to justify policies of supplying health care workers, and perhaps patients and visitors, too, with inadequate protection,” Trish Greenhalgh, MD, professor of primary care health sciences at the University of Oxford (England), told this news organization.
“These authors have been pushing back against treating COVID as airborne for 3 years,” David Fisman, MD, an epidemiologist and infectious disease specialist at the University of Toronto, said in an interview. “So, you’ll see these folks brandishing this very flawed trial to justify continuing the infection control practices that have been so disastrous throughout the pandemic.”
The study was funded by the World Health Organization, the Canadian Institutes of Health Research, and the Juravinski Research Institute. Dr. Conly reported receiving grants from the Canadian Institutes for Health Research, Pfizer, and the WHO. Dr. Chou disclosed being a methodologist for WHO guidelines on infection prevention and control measures for COVID-19. Dr. Loeb disclosed payment for expert testimony on personal protective equipment from the government of Manitoba and the Peel District School Board. Dr. MacIntyre has led a large body of research on masks and respirators in health workers, including four randomized clinical trials. She is the author of a book, “Dark Winter: An insider’s guide to pandemics and biosecurity” (Syndey: NewSouth Publishing, 2022), which covers the history and politics of the controversies around N95 and masks. Dr. Prather reported no disclosures. Dr. Greenhalgh is a member of Independent SAGE and an unpaid adviser to the philanthropic fund Balvi. Dr. Fisman has served as a paid legal expert for the Ontario Nurses’ Association in their challenge to Directive 5, which restricted access to N95 masks in health care. He also served as a paid legal expert for the Elementary Teachers’ Federation of Ontario in its efforts to make schools safer in Ontario.
A version of this article first appeared on Medscape.com.
The study’s senior author is John Conly, MD, an infectious disease specialist and professor at the University of Calgary (Alta.), and Alberta Health Services. The findings are not consistent with those of many other studies on this topic.
Commenting about Dr. Conly’s study, Eric Topol, MD, editor-in-chief of Medscape, wrote: “It’s woefully underpowered but ruled out a doubling of hazard for use of medical masks.”
The study, which was partially funded by the World Health Organization, was published online in Annals of Internal Medicine.
This is not the first time that Dr. Conly, who also advises the WHO, has been the subject of controversy. He previously denied that COVID-19 is airborne – a position that is contradicted by strong evidence. In 2021, Dr. Conly made headlines with his controversial claim that N95 respirators can cause harms, including oxygen depletion and carbon dioxide retention.
A detailed examination by the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota, Minneapolis, pointed out numerous scientific flaws in the study, including inconsistent use of both types of masks. The study also examined health care workers in four very different countries (Canada, Israel, Egypt, and Pakistan) during different periods of the pandemic, which may have affected the results. Furthermore, the study did not account for vaccination status and lacked a control group. CIDRAP receives funding from 3M, which makes N95 respirators.
In a commentary published alongside the study, Roger Chou, MD, professor of medicine at Oregon Health & Science University, Portland, said that the results were “not definitive,” with “a generous noninferiority threshold” that is actually “consistent with up to a relative 70% increased risk ... which may be unacceptable to many health workers.”
Lead study author Mark Loeb, MD, professor of infectious diseases at McMaster University, Hamilton, Ont., defended the findings. “The confidence intervals around this, that is, what the possible results could be if the trial was repeated many times, range from −2.5% to 4.9%,” he told this news organization. “This means that the risk of a COVID-19 infection in those using the medical masks could have ranged from anywhere from 2.5% reduction in risk to a 4.9% increase in risk. Readers and policy makers can decide for themselves about this.”
“There is no point continuing to run underpowered, poorly designed studies that are designed to confirm existing biases,” Raina MacIntyre, PhD, professor of global biosecurity and head of the Biosecurity Program at the Kirby Institute, Sydney, said in an interview. “The new study in Annals of Internal Medicine is entirely consistent with our finding that to prevent infection, you need an N95, and it needs to be worn throughout the whole shift. A surgical mask and intermittent use of N95 are equally ineffective. This should not surprise anyone, given a surgical mask is not designed as respiratory protection but is designed to prevent splash or spray of liquid on the face. Only a respirator is designed as respiratory protection through both the seal around the face and the filter of the face piece to prevent inhalation of virus laden aerosols, but you need to wear it continually in a high-risk environment like a hospital.”
“It makes zero sense to do a randomized trial on something you can measure directly,” said Kimberly Prather, PhD, an atmospheric chemist, professor, and director of the NSF Center for Aerosol Impacts on Chemistry of the Environment at the University of California, San Diego. “In fact, many studies have shown aerosols leaking out of surgical masks. Surgical masks are designed to block large spray droplets. Aerosols (0.5-3 mcm), which have been shown to contain infectious SARS-CoV-2 virus, travel with the air flow, and escape.”
“This study ... will be used to justify policies of supplying health care workers, and perhaps patients and visitors, too, with inadequate protection,” Trish Greenhalgh, MD, professor of primary care health sciences at the University of Oxford (England), told this news organization.
“These authors have been pushing back against treating COVID as airborne for 3 years,” David Fisman, MD, an epidemiologist and infectious disease specialist at the University of Toronto, said in an interview. “So, you’ll see these folks brandishing this very flawed trial to justify continuing the infection control practices that have been so disastrous throughout the pandemic.”
The study was funded by the World Health Organization, the Canadian Institutes of Health Research, and the Juravinski Research Institute. Dr. Conly reported receiving grants from the Canadian Institutes for Health Research, Pfizer, and the WHO. Dr. Chou disclosed being a methodologist for WHO guidelines on infection prevention and control measures for COVID-19. Dr. Loeb disclosed payment for expert testimony on personal protective equipment from the government of Manitoba and the Peel District School Board. Dr. MacIntyre has led a large body of research on masks and respirators in health workers, including four randomized clinical trials. She is the author of a book, “Dark Winter: An insider’s guide to pandemics and biosecurity” (Syndey: NewSouth Publishing, 2022), which covers the history and politics of the controversies around N95 and masks. Dr. Prather reported no disclosures. Dr. Greenhalgh is a member of Independent SAGE and an unpaid adviser to the philanthropic fund Balvi. Dr. Fisman has served as a paid legal expert for the Ontario Nurses’ Association in their challenge to Directive 5, which restricted access to N95 masks in health care. He also served as a paid legal expert for the Elementary Teachers’ Federation of Ontario in its efforts to make schools safer in Ontario.
A version of this article first appeared on Medscape.com.
FROM ANNALS OF INTERNAL MEDICINE
Have long COVID? Newest booster vaccines may help you
Yet at 58, the Arizona writer is in no hurry to get the latest vaccine booster. “I just don’t want to risk getting any sicker,” she said.
Ms. Dishner has had two doses of vaccine plus two boosters. Each time, she had what regulators consider to be mild reactions, including a sore arm, slight fever, nausea, and body aches. Still, there’s some evidence that the newest booster, which protects against some of the later variants, could help people like Ms. Dishner in several ways, said Ziyad Al-Aly, MD, a clinical epidemiologist and prolific long COVID researcher at Washington University in St. Louis.
“A bivalent booster might actually [help with] your long COVID,” he said.
There may be other benefits. “What vaccines or current vaccine boosters do is reduce your risk of progression to severe COVID-19 illness,” Dr. Al-Aly said. “You are avoiding hospital stays or even worse; you’re avoiding potentially fatal outcomes after infection. And that’s really worth it. Who wants to be in the hospital this Christmas holiday?”
Each time people are infected with SARS-CoV-2, the virus that causes COVID-19, they have a fresh risk of not only getting severely ill or dying, but of developing long COVID, Dr. Al-Aly and colleagues found in a study published in Nature Medicine. “If you dodged the bullet the first time and did not get long COVID after the first infection, if you get reinfected, you’re trying your luck again,” Dr. Al-Aly said. “I would advise people not to get reinfected, which is another reason to get the booster.”
In a recent review in The Lancet eClinicalMedicine, an international team of researchers looked at 11 studies that sought to find out if vaccines affected long COVID symptoms. Seven of those studies found that people’s symptoms improved after they were vaccinated, and four found that symptoms mostly remained the same. One found symptoms got worse in some patients.
A study of 28,000 people published in the British Medical Journal found more evidence that vaccination may help ease symptoms. “Vaccination may contribute to a reduction in the population health burden of long COVID,” the team at the United Kingdom’s Office for National Statistics concluded. Most studies found vaccination reduced the risk of getting long COVID in the first place.
Vaccines prompt the body to produce antibodies, which stop a microbe from infecting cells. They also prompt the production of immune cells called T cells, which continue to hunt down and attack a pathogen even after infection.
A booster dose could help rev up that immune response in a patient with long COVID, said Stephen J. Thomas, MD, an infectious disease specialist at Upstate Medical Center in Syracuse, N.Y., and the center’s lead principal investigator for Pfizer/BioNTech’s COVID-19 2020 vaccine trial.
Some scientists believe long COVID might be caused when the virus persists in parts of the body where the immune system isn’t particularly active. Although they don’t fully understand the workings of the many and varied long COVID symptoms, they have a good idea about why people with long COVID often do better after receiving a vaccine or booster.
“The theory is that by boosting, the immune system may be able to ‘mop up’ those virus stragglers that have remained behind after your first cleanup attempt,” Dr. Thomas said.
“The vaccine is almost lending a hand or helping your immune response to clear that virus,” Dr. Al-Aly said.
It could be difficult for long COVID patients to make an informed decision about boosters, given the lack of studies that focus exclusively on the relationship between long COVID and boosters, according to Scott Roberts, MD, associate medical director for infection prevention at Yale New Haven (Conn.) Hospital.
Dr. Roberts recommended that patients speak with their health care providers and read about the bivalent booster on trusted sites such as those sponsored by the Food and Drug Administration and the Centers for Disease Control and Prevention. Long COVID patients should get the latest boosters, especially as there’s no evidence they are unsafe for them. “The antibody response is appropriately boosted, and there is a decent chance this will help reduce the impact of long COVID as well,” he said. “Waiting will only increase the risk of getting infected and increase the chances of long COVID.”
Only 12% of Americans 5 years and older have received the updated booster, according to the CDC, although it’s recommended for everyone. Just over 80% of Americans have gotten at least one vaccine dose. Dr. Thomas understands why the uptake has been so low: Along with people like Ms. Dishner, who fear more side effects or worse symptoms, there are those who believe that hybrid immunity – vaccination immunity plus natural infection – is superior to vaccination alone and that they don’t need a booster.
Studies show that the bivalent boosters, which protect against older and newer variants, can target even the new, predominant COVID-19 strains. Whether that is enough to convince people in the no-booster camp who lost faith when their vaccinated peers started getting COVID-19 is unclear, although, as Dr. Al-Aly has pointed out, vaccinations help keep people from getting so sick that they wind up in the hospital. And, with most of the population having received at least one dose of vaccine, most of those getting infected will naturally come from among the vaccinated.
Thomas describes the expectation that vaccines would prevent everyone from getting sick as “one of the major fails” of the pandemic.
Counting on a vaccine to confer 100% immunity is “a very high bar,” he said. “I think that’s what people expected, and when they weren’t seeing it, they kind of said: ‘Well, what’s the point? You know, things are getting better. I’d rather take my chances than keep going and getting boosted.’ ”
One point – and it’s a critical one – is that vaccination immunity wanes. Plus new variants arise that can evade at least some of the immunity provided by vaccination. That’s why boosters are built into the COVID vaccination program.
While it’s not clear why some long COVID patients see improvements in their symptoms after being vaccinated or boosted and others do not, Dr. Al-Aly said there’s little evidence vaccines can make long COVID worse. “There are some reports out there that some people with long COVID, when they got a vaccine or booster, their symptoms got worse. You’ll read anecdotes on this side,” he said, adding that efforts to see if this is really happening have been inconclusive.
“The general consensus is that vaccines really save lives,” Dr. Al-Aly said. “Getting vaccinated, even if you are a long COVID patient, is better than not getting vaccinated.”
A version of this article first appeared on WebMD.com.
Yet at 58, the Arizona writer is in no hurry to get the latest vaccine booster. “I just don’t want to risk getting any sicker,” she said.
Ms. Dishner has had two doses of vaccine plus two boosters. Each time, she had what regulators consider to be mild reactions, including a sore arm, slight fever, nausea, and body aches. Still, there’s some evidence that the newest booster, which protects against some of the later variants, could help people like Ms. Dishner in several ways, said Ziyad Al-Aly, MD, a clinical epidemiologist and prolific long COVID researcher at Washington University in St. Louis.
“A bivalent booster might actually [help with] your long COVID,” he said.
There may be other benefits. “What vaccines or current vaccine boosters do is reduce your risk of progression to severe COVID-19 illness,” Dr. Al-Aly said. “You are avoiding hospital stays or even worse; you’re avoiding potentially fatal outcomes after infection. And that’s really worth it. Who wants to be in the hospital this Christmas holiday?”
Each time people are infected with SARS-CoV-2, the virus that causes COVID-19, they have a fresh risk of not only getting severely ill or dying, but of developing long COVID, Dr. Al-Aly and colleagues found in a study published in Nature Medicine. “If you dodged the bullet the first time and did not get long COVID after the first infection, if you get reinfected, you’re trying your luck again,” Dr. Al-Aly said. “I would advise people not to get reinfected, which is another reason to get the booster.”
In a recent review in The Lancet eClinicalMedicine, an international team of researchers looked at 11 studies that sought to find out if vaccines affected long COVID symptoms. Seven of those studies found that people’s symptoms improved after they were vaccinated, and four found that symptoms mostly remained the same. One found symptoms got worse in some patients.
A study of 28,000 people published in the British Medical Journal found more evidence that vaccination may help ease symptoms. “Vaccination may contribute to a reduction in the population health burden of long COVID,” the team at the United Kingdom’s Office for National Statistics concluded. Most studies found vaccination reduced the risk of getting long COVID in the first place.
Vaccines prompt the body to produce antibodies, which stop a microbe from infecting cells. They also prompt the production of immune cells called T cells, which continue to hunt down and attack a pathogen even after infection.
A booster dose could help rev up that immune response in a patient with long COVID, said Stephen J. Thomas, MD, an infectious disease specialist at Upstate Medical Center in Syracuse, N.Y., and the center’s lead principal investigator for Pfizer/BioNTech’s COVID-19 2020 vaccine trial.
Some scientists believe long COVID might be caused when the virus persists in parts of the body where the immune system isn’t particularly active. Although they don’t fully understand the workings of the many and varied long COVID symptoms, they have a good idea about why people with long COVID often do better after receiving a vaccine or booster.
“The theory is that by boosting, the immune system may be able to ‘mop up’ those virus stragglers that have remained behind after your first cleanup attempt,” Dr. Thomas said.
“The vaccine is almost lending a hand or helping your immune response to clear that virus,” Dr. Al-Aly said.
It could be difficult for long COVID patients to make an informed decision about boosters, given the lack of studies that focus exclusively on the relationship between long COVID and boosters, according to Scott Roberts, MD, associate medical director for infection prevention at Yale New Haven (Conn.) Hospital.
Dr. Roberts recommended that patients speak with their health care providers and read about the bivalent booster on trusted sites such as those sponsored by the Food and Drug Administration and the Centers for Disease Control and Prevention. Long COVID patients should get the latest boosters, especially as there’s no evidence they are unsafe for them. “The antibody response is appropriately boosted, and there is a decent chance this will help reduce the impact of long COVID as well,” he said. “Waiting will only increase the risk of getting infected and increase the chances of long COVID.”
Only 12% of Americans 5 years and older have received the updated booster, according to the CDC, although it’s recommended for everyone. Just over 80% of Americans have gotten at least one vaccine dose. Dr. Thomas understands why the uptake has been so low: Along with people like Ms. Dishner, who fear more side effects or worse symptoms, there are those who believe that hybrid immunity – vaccination immunity plus natural infection – is superior to vaccination alone and that they don’t need a booster.
Studies show that the bivalent boosters, which protect against older and newer variants, can target even the new, predominant COVID-19 strains. Whether that is enough to convince people in the no-booster camp who lost faith when their vaccinated peers started getting COVID-19 is unclear, although, as Dr. Al-Aly has pointed out, vaccinations help keep people from getting so sick that they wind up in the hospital. And, with most of the population having received at least one dose of vaccine, most of those getting infected will naturally come from among the vaccinated.
Thomas describes the expectation that vaccines would prevent everyone from getting sick as “one of the major fails” of the pandemic.
Counting on a vaccine to confer 100% immunity is “a very high bar,” he said. “I think that’s what people expected, and when they weren’t seeing it, they kind of said: ‘Well, what’s the point? You know, things are getting better. I’d rather take my chances than keep going and getting boosted.’ ”
One point – and it’s a critical one – is that vaccination immunity wanes. Plus new variants arise that can evade at least some of the immunity provided by vaccination. That’s why boosters are built into the COVID vaccination program.
While it’s not clear why some long COVID patients see improvements in their symptoms after being vaccinated or boosted and others do not, Dr. Al-Aly said there’s little evidence vaccines can make long COVID worse. “There are some reports out there that some people with long COVID, when they got a vaccine or booster, their symptoms got worse. You’ll read anecdotes on this side,” he said, adding that efforts to see if this is really happening have been inconclusive.
“The general consensus is that vaccines really save lives,” Dr. Al-Aly said. “Getting vaccinated, even if you are a long COVID patient, is better than not getting vaccinated.”
A version of this article first appeared on WebMD.com.
Yet at 58, the Arizona writer is in no hurry to get the latest vaccine booster. “I just don’t want to risk getting any sicker,” she said.
Ms. Dishner has had two doses of vaccine plus two boosters. Each time, she had what regulators consider to be mild reactions, including a sore arm, slight fever, nausea, and body aches. Still, there’s some evidence that the newest booster, which protects against some of the later variants, could help people like Ms. Dishner in several ways, said Ziyad Al-Aly, MD, a clinical epidemiologist and prolific long COVID researcher at Washington University in St. Louis.
“A bivalent booster might actually [help with] your long COVID,” he said.
There may be other benefits. “What vaccines or current vaccine boosters do is reduce your risk of progression to severe COVID-19 illness,” Dr. Al-Aly said. “You are avoiding hospital stays or even worse; you’re avoiding potentially fatal outcomes after infection. And that’s really worth it. Who wants to be in the hospital this Christmas holiday?”
Each time people are infected with SARS-CoV-2, the virus that causes COVID-19, they have a fresh risk of not only getting severely ill or dying, but of developing long COVID, Dr. Al-Aly and colleagues found in a study published in Nature Medicine. “If you dodged the bullet the first time and did not get long COVID after the first infection, if you get reinfected, you’re trying your luck again,” Dr. Al-Aly said. “I would advise people not to get reinfected, which is another reason to get the booster.”
In a recent review in The Lancet eClinicalMedicine, an international team of researchers looked at 11 studies that sought to find out if vaccines affected long COVID symptoms. Seven of those studies found that people’s symptoms improved after they were vaccinated, and four found that symptoms mostly remained the same. One found symptoms got worse in some patients.
A study of 28,000 people published in the British Medical Journal found more evidence that vaccination may help ease symptoms. “Vaccination may contribute to a reduction in the population health burden of long COVID,” the team at the United Kingdom’s Office for National Statistics concluded. Most studies found vaccination reduced the risk of getting long COVID in the first place.
Vaccines prompt the body to produce antibodies, which stop a microbe from infecting cells. They also prompt the production of immune cells called T cells, which continue to hunt down and attack a pathogen even after infection.
A booster dose could help rev up that immune response in a patient with long COVID, said Stephen J. Thomas, MD, an infectious disease specialist at Upstate Medical Center in Syracuse, N.Y., and the center’s lead principal investigator for Pfizer/BioNTech’s COVID-19 2020 vaccine trial.
Some scientists believe long COVID might be caused when the virus persists in parts of the body where the immune system isn’t particularly active. Although they don’t fully understand the workings of the many and varied long COVID symptoms, they have a good idea about why people with long COVID often do better after receiving a vaccine or booster.
“The theory is that by boosting, the immune system may be able to ‘mop up’ those virus stragglers that have remained behind after your first cleanup attempt,” Dr. Thomas said.
“The vaccine is almost lending a hand or helping your immune response to clear that virus,” Dr. Al-Aly said.
It could be difficult for long COVID patients to make an informed decision about boosters, given the lack of studies that focus exclusively on the relationship between long COVID and boosters, according to Scott Roberts, MD, associate medical director for infection prevention at Yale New Haven (Conn.) Hospital.
Dr. Roberts recommended that patients speak with their health care providers and read about the bivalent booster on trusted sites such as those sponsored by the Food and Drug Administration and the Centers for Disease Control and Prevention. Long COVID patients should get the latest boosters, especially as there’s no evidence they are unsafe for them. “The antibody response is appropriately boosted, and there is a decent chance this will help reduce the impact of long COVID as well,” he said. “Waiting will only increase the risk of getting infected and increase the chances of long COVID.”
Only 12% of Americans 5 years and older have received the updated booster, according to the CDC, although it’s recommended for everyone. Just over 80% of Americans have gotten at least one vaccine dose. Dr. Thomas understands why the uptake has been so low: Along with people like Ms. Dishner, who fear more side effects or worse symptoms, there are those who believe that hybrid immunity – vaccination immunity plus natural infection – is superior to vaccination alone and that they don’t need a booster.
Studies show that the bivalent boosters, which protect against older and newer variants, can target even the new, predominant COVID-19 strains. Whether that is enough to convince people in the no-booster camp who lost faith when their vaccinated peers started getting COVID-19 is unclear, although, as Dr. Al-Aly has pointed out, vaccinations help keep people from getting so sick that they wind up in the hospital. And, with most of the population having received at least one dose of vaccine, most of those getting infected will naturally come from among the vaccinated.
Thomas describes the expectation that vaccines would prevent everyone from getting sick as “one of the major fails” of the pandemic.
Counting on a vaccine to confer 100% immunity is “a very high bar,” he said. “I think that’s what people expected, and when they weren’t seeing it, they kind of said: ‘Well, what’s the point? You know, things are getting better. I’d rather take my chances than keep going and getting boosted.’ ”
One point – and it’s a critical one – is that vaccination immunity wanes. Plus new variants arise that can evade at least some of the immunity provided by vaccination. That’s why boosters are built into the COVID vaccination program.
While it’s not clear why some long COVID patients see improvements in their symptoms after being vaccinated or boosted and others do not, Dr. Al-Aly said there’s little evidence vaccines can make long COVID worse. “There are some reports out there that some people with long COVID, when they got a vaccine or booster, their symptoms got worse. You’ll read anecdotes on this side,” he said, adding that efforts to see if this is really happening have been inconclusive.
“The general consensus is that vaccines really save lives,” Dr. Al-Aly said. “Getting vaccinated, even if you are a long COVID patient, is better than not getting vaccinated.”
A version of this article first appeared on WebMD.com.
FROM NATURE MEDICINE
Not all plant-based diets equal for CRC risk reduction
although the strength of the association may vary by race and ethnicity and tumor site, new research shows.
The “take-home message is that improving the quality of plant foods and reducing animal food consumption can help prevent colorectal cancer in men,” Jihye Kim told this news organization.
The findings suggest that “not all plant-based diets are the same with regard to colorectal cancer protection/risk,” said Ms. Kim, a professor in the College of Life and Sciences at Kyung Hee University in South Korea.
The study was published online in BMC Medicine.
The researchers investigated the risk for CRC in association with three plant-based dietary patterns defined by a priori indices: an overall plant-based diet index (PDI), a healthful plant-based diet index (hPDI), and an unhealthful plant-based diet index (uPDI).
All three indices negatively weigh animal foods but weigh plant foods differently depending on their nutritional quality.
Examples of foods contained in the hPDI include whole grains, fruits, vegetables, vegetable oils, nuts, legumes, tea, and coffee. Foods in the uPDI include refined grains, fruit juices, potatoes, and added sugars.
They calculated the PDI, hPDI, and uPDI using data from quantitative food frequency questionnaires provided by 79,952 men (mean age, 60 years at baseline) and 93,475 women (mean age, 59 years at baseline) in the Multiethnic Cohort Study.
During a mean follow-up of about 19 years, 4,976 participants developed CRC.
The plant-based diet indices were significantly inversely associated with the risk for CRC in men.
Researchers found that men with the greatest adherence to PDI and hPDI had a 24% (hazard ratio, 0.76) and 21% (HR, 0.79) lower risk for CRC, respectively, compared with men with the lowest adherence. No significant association was found between the risk for CRC in men and uPDI.
None of the plant-based diet indices was significantly associated with the risk for CRC in women, which could be because of different dietary habits between men and women, the researchers say.
In general, women consume more plant foods and less animal foods than men do, they point out.
In addition, women in the Multiethnic Cohort Study consumed higher amounts of healthy plant foods and lower amounts of less healthy plant foods compared with men, so they may not have further benefits with high scores of plant-based diet indices. Also, men are at higher risk for CRC than women are in general.
These findings suggest that the benefits from plant-based diets may vary by sex, race, and ethnicity, and anatomic subsite of tumor.
In men, the inverse association of overall PDI was greater in Japanese American, Native Hawaiian, and White groups than in African American and Latino groups, and for left colon and rectum tumors than for right colon tumors. The decreased risk with the hPDI was suggested across racial and ethnic groups and was observed for all tumor subsites.
“It was interesting to see that the association of a plant-based diet with CRC varied by race and ethnicity. It is not clear why. It could be nondietary lifestyle factors or genetic factors,” Ms. Kim told this news organization.
“We should investigate that more in the future,” Ms. Kim added.
By way of limitations, it’s possible that residual or unmeasured confounding might exist despite adjustment for key CRC risk factors, the researchers say. However, the subgroup analyses suggest that the impact of residual confounding due to body mass index, smoking status, and alcohol consumption was “minimal,” they note.
Another limitation is that the analysis was based on diet measured only at baseline, but dietary habits might change over time.
Overall, the findings “support that improving the quality of plant foods and reducing animal food consumption can help prevent colorectal cancer,” Ms. Kim and colleagues say.
The study was supported by the National Research Foundation of Korea and the U.S. National Cancer Institute and National Institutes of Health. The authors have declared no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
although the strength of the association may vary by race and ethnicity and tumor site, new research shows.
The “take-home message is that improving the quality of plant foods and reducing animal food consumption can help prevent colorectal cancer in men,” Jihye Kim told this news organization.
The findings suggest that “not all plant-based diets are the same with regard to colorectal cancer protection/risk,” said Ms. Kim, a professor in the College of Life and Sciences at Kyung Hee University in South Korea.
The study was published online in BMC Medicine.
The researchers investigated the risk for CRC in association with three plant-based dietary patterns defined by a priori indices: an overall plant-based diet index (PDI), a healthful plant-based diet index (hPDI), and an unhealthful plant-based diet index (uPDI).
All three indices negatively weigh animal foods but weigh plant foods differently depending on their nutritional quality.
Examples of foods contained in the hPDI include whole grains, fruits, vegetables, vegetable oils, nuts, legumes, tea, and coffee. Foods in the uPDI include refined grains, fruit juices, potatoes, and added sugars.
They calculated the PDI, hPDI, and uPDI using data from quantitative food frequency questionnaires provided by 79,952 men (mean age, 60 years at baseline) and 93,475 women (mean age, 59 years at baseline) in the Multiethnic Cohort Study.
During a mean follow-up of about 19 years, 4,976 participants developed CRC.
The plant-based diet indices were significantly inversely associated with the risk for CRC in men.
Researchers found that men with the greatest adherence to PDI and hPDI had a 24% (hazard ratio, 0.76) and 21% (HR, 0.79) lower risk for CRC, respectively, compared with men with the lowest adherence. No significant association was found between the risk for CRC in men and uPDI.
None of the plant-based diet indices was significantly associated with the risk for CRC in women, which could be because of different dietary habits between men and women, the researchers say.
In general, women consume more plant foods and less animal foods than men do, they point out.
In addition, women in the Multiethnic Cohort Study consumed higher amounts of healthy plant foods and lower amounts of less healthy plant foods compared with men, so they may not have further benefits with high scores of plant-based diet indices. Also, men are at higher risk for CRC than women are in general.
These findings suggest that the benefits from plant-based diets may vary by sex, race, and ethnicity, and anatomic subsite of tumor.
In men, the inverse association of overall PDI was greater in Japanese American, Native Hawaiian, and White groups than in African American and Latino groups, and for left colon and rectum tumors than for right colon tumors. The decreased risk with the hPDI was suggested across racial and ethnic groups and was observed for all tumor subsites.
“It was interesting to see that the association of a plant-based diet with CRC varied by race and ethnicity. It is not clear why. It could be nondietary lifestyle factors or genetic factors,” Ms. Kim told this news organization.
“We should investigate that more in the future,” Ms. Kim added.
By way of limitations, it’s possible that residual or unmeasured confounding might exist despite adjustment for key CRC risk factors, the researchers say. However, the subgroup analyses suggest that the impact of residual confounding due to body mass index, smoking status, and alcohol consumption was “minimal,” they note.
Another limitation is that the analysis was based on diet measured only at baseline, but dietary habits might change over time.
Overall, the findings “support that improving the quality of plant foods and reducing animal food consumption can help prevent colorectal cancer,” Ms. Kim and colleagues say.
The study was supported by the National Research Foundation of Korea and the U.S. National Cancer Institute and National Institutes of Health. The authors have declared no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
although the strength of the association may vary by race and ethnicity and tumor site, new research shows.
The “take-home message is that improving the quality of plant foods and reducing animal food consumption can help prevent colorectal cancer in men,” Jihye Kim told this news organization.
The findings suggest that “not all plant-based diets are the same with regard to colorectal cancer protection/risk,” said Ms. Kim, a professor in the College of Life and Sciences at Kyung Hee University in South Korea.
The study was published online in BMC Medicine.
The researchers investigated the risk for CRC in association with three plant-based dietary patterns defined by a priori indices: an overall plant-based diet index (PDI), a healthful plant-based diet index (hPDI), and an unhealthful plant-based diet index (uPDI).
All three indices negatively weigh animal foods but weigh plant foods differently depending on their nutritional quality.
Examples of foods contained in the hPDI include whole grains, fruits, vegetables, vegetable oils, nuts, legumes, tea, and coffee. Foods in the uPDI include refined grains, fruit juices, potatoes, and added sugars.
They calculated the PDI, hPDI, and uPDI using data from quantitative food frequency questionnaires provided by 79,952 men (mean age, 60 years at baseline) and 93,475 women (mean age, 59 years at baseline) in the Multiethnic Cohort Study.
During a mean follow-up of about 19 years, 4,976 participants developed CRC.
The plant-based diet indices were significantly inversely associated with the risk for CRC in men.
Researchers found that men with the greatest adherence to PDI and hPDI had a 24% (hazard ratio, 0.76) and 21% (HR, 0.79) lower risk for CRC, respectively, compared with men with the lowest adherence. No significant association was found between the risk for CRC in men and uPDI.
None of the plant-based diet indices was significantly associated with the risk for CRC in women, which could be because of different dietary habits between men and women, the researchers say.
In general, women consume more plant foods and less animal foods than men do, they point out.
In addition, women in the Multiethnic Cohort Study consumed higher amounts of healthy plant foods and lower amounts of less healthy plant foods compared with men, so they may not have further benefits with high scores of plant-based diet indices. Also, men are at higher risk for CRC than women are in general.
These findings suggest that the benefits from plant-based diets may vary by sex, race, and ethnicity, and anatomic subsite of tumor.
In men, the inverse association of overall PDI was greater in Japanese American, Native Hawaiian, and White groups than in African American and Latino groups, and for left colon and rectum tumors than for right colon tumors. The decreased risk with the hPDI was suggested across racial and ethnic groups and was observed for all tumor subsites.
“It was interesting to see that the association of a plant-based diet with CRC varied by race and ethnicity. It is not clear why. It could be nondietary lifestyle factors or genetic factors,” Ms. Kim told this news organization.
“We should investigate that more in the future,” Ms. Kim added.
By way of limitations, it’s possible that residual or unmeasured confounding might exist despite adjustment for key CRC risk factors, the researchers say. However, the subgroup analyses suggest that the impact of residual confounding due to body mass index, smoking status, and alcohol consumption was “minimal,” they note.
Another limitation is that the analysis was based on diet measured only at baseline, but dietary habits might change over time.
Overall, the findings “support that improving the quality of plant foods and reducing animal food consumption can help prevent colorectal cancer,” Ms. Kim and colleagues say.
The study was supported by the National Research Foundation of Korea and the U.S. National Cancer Institute and National Institutes of Health. The authors have declared no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
FROM BMC MEDICINE
FDA OKs first fecal microbiota therapy for recurrent C. difficile
Rebyota (fecal microbiota, live-jslm), from Ferring Pharmaceuticals, is intended for use after an individual has completed antibiotic treatment for recurrent CDI. It is not indicated for the first occurrence of CDI.
“Recurrent CDI impacts an individual’s quality of life and can also potentially be life-threatening,” Peter Marks, MD, PhD, director, FDA Center for Biologics Evaluation and Research, said in a statement announcing approval.
As the first FDA-approved fecal microbiota product, this approval “represents an important milestone, as it provides an additional approved option to prevent recurrent CDI,” Dr. Marks added.
A panel of FDA advisors recommended approval of Rebyota in September.
The application for Rebyota received priority review and had orphan drug and breakthrough therapy designation.
A vicious cycle
Treatment options for recurrent CDI are limited. It’s been estimated that up to one-third of CDI cases recur, and people who suffer a recurrent bout of CDI are at a significantly higher risk for further infections.
Following the first recurrence, up to two-thirds of patients may experience a subsequent recurrence. Antibiotics used to treat CDI may contribute to a cycle of recurrence by altering the gut flora. The administration of fecal microbiota helps restore the gut flora to prevent further episodes of CDI.
“This is a major milestone in the translation of gut microbiome science to clinical solutions for patients,” Phillip I. Tarr, MD, chair of the American Gastroenterological Association’s Center for Gut Microbiome Research and Education Scientific Advisory Board, said in a written statement issued by the AGA. “This accomplishment is based on decades of work on the gut microbiome by gastroenterologists and collaborators. AGA applauds FDA for recognizing the demonstrated and conceptual merit of microbiota-based therapies.”
Rebyota is a microbiota-based live biotherapeutic prepared from human stool collected from prescreened, qualified donors. It comes prepackaged in a single dose that is administered rectally.
The safety and efficacy of Rebyota were assessed in five clinical trials with more than 1,000 participants, the company notes in a press release.
In one trial, following a standard course of antibiotics, a one-time treatment with Rebyota was successful for three-quarters of participants at 8 weeks.
The treatment also prevented additional bouts; 84% of these initial responders remaining free of CDI at 6 months.
Two-thirds of participants reported treatment-emergent adverse events. Most events were mild to moderate in severity. Diarrhea and abdominal pain were the most common.
The data, from the ongoing PUNCH CD3-OLS study, were presented in October at the annual meeting of the American College of Gastroenterology and were published simultaneously in the journal Drugs.
“This is a positive adjunct to our current therapies for C. difficile in terms of trying to knock it out once a standard course of antibiotics has been administered,” Lisa Malter, MD, a gastroenterologist and professor of medicine at New York University Langone Health, said in an interview.
Dr. Malter acknowledged that, because it’s delivered rectally, there could be “some hesitation” on the patient’s part to undergo the therapy.
However, C. difficile can be “excruciating” for patients, and they “may be more than willing to take [this agent] because it gets them feeling better,” said Dr. Malter said, who reported no relevant financial relationships.
The AGA will continue to follow the long-term effectiveness and safety of patients receiving Rebyota, fecal microbiota transplant, and other microbiota-based therapies through its FMT National Registry, according to the AGA statement.
Full prescribing information for Rebyota is available online.
For more information about CDI and FMT, visit patient.gastro.org.
Rebyota (fecal microbiota, live-jslm), from Ferring Pharmaceuticals, is intended for use after an individual has completed antibiotic treatment for recurrent CDI. It is not indicated for the first occurrence of CDI.
“Recurrent CDI impacts an individual’s quality of life and can also potentially be life-threatening,” Peter Marks, MD, PhD, director, FDA Center for Biologics Evaluation and Research, said in a statement announcing approval.
As the first FDA-approved fecal microbiota product, this approval “represents an important milestone, as it provides an additional approved option to prevent recurrent CDI,” Dr. Marks added.
A panel of FDA advisors recommended approval of Rebyota in September.
The application for Rebyota received priority review and had orphan drug and breakthrough therapy designation.
A vicious cycle
Treatment options for recurrent CDI are limited. It’s been estimated that up to one-third of CDI cases recur, and people who suffer a recurrent bout of CDI are at a significantly higher risk for further infections.
Following the first recurrence, up to two-thirds of patients may experience a subsequent recurrence. Antibiotics used to treat CDI may contribute to a cycle of recurrence by altering the gut flora. The administration of fecal microbiota helps restore the gut flora to prevent further episodes of CDI.
“This is a major milestone in the translation of gut microbiome science to clinical solutions for patients,” Phillip I. Tarr, MD, chair of the American Gastroenterological Association’s Center for Gut Microbiome Research and Education Scientific Advisory Board, said in a written statement issued by the AGA. “This accomplishment is based on decades of work on the gut microbiome by gastroenterologists and collaborators. AGA applauds FDA for recognizing the demonstrated and conceptual merit of microbiota-based therapies.”
Rebyota is a microbiota-based live biotherapeutic prepared from human stool collected from prescreened, qualified donors. It comes prepackaged in a single dose that is administered rectally.
The safety and efficacy of Rebyota were assessed in five clinical trials with more than 1,000 participants, the company notes in a press release.
In one trial, following a standard course of antibiotics, a one-time treatment with Rebyota was successful for three-quarters of participants at 8 weeks.
The treatment also prevented additional bouts; 84% of these initial responders remaining free of CDI at 6 months.
Two-thirds of participants reported treatment-emergent adverse events. Most events were mild to moderate in severity. Diarrhea and abdominal pain were the most common.
The data, from the ongoing PUNCH CD3-OLS study, were presented in October at the annual meeting of the American College of Gastroenterology and were published simultaneously in the journal Drugs.
“This is a positive adjunct to our current therapies for C. difficile in terms of trying to knock it out once a standard course of antibiotics has been administered,” Lisa Malter, MD, a gastroenterologist and professor of medicine at New York University Langone Health, said in an interview.
Dr. Malter acknowledged that, because it’s delivered rectally, there could be “some hesitation” on the patient’s part to undergo the therapy.
However, C. difficile can be “excruciating” for patients, and they “may be more than willing to take [this agent] because it gets them feeling better,” said Dr. Malter said, who reported no relevant financial relationships.
The AGA will continue to follow the long-term effectiveness and safety of patients receiving Rebyota, fecal microbiota transplant, and other microbiota-based therapies through its FMT National Registry, according to the AGA statement.
Full prescribing information for Rebyota is available online.
For more information about CDI and FMT, visit patient.gastro.org.
Rebyota (fecal microbiota, live-jslm), from Ferring Pharmaceuticals, is intended for use after an individual has completed antibiotic treatment for recurrent CDI. It is not indicated for the first occurrence of CDI.
“Recurrent CDI impacts an individual’s quality of life and can also potentially be life-threatening,” Peter Marks, MD, PhD, director, FDA Center for Biologics Evaluation and Research, said in a statement announcing approval.
As the first FDA-approved fecal microbiota product, this approval “represents an important milestone, as it provides an additional approved option to prevent recurrent CDI,” Dr. Marks added.
A panel of FDA advisors recommended approval of Rebyota in September.
The application for Rebyota received priority review and had orphan drug and breakthrough therapy designation.
A vicious cycle
Treatment options for recurrent CDI are limited. It’s been estimated that up to one-third of CDI cases recur, and people who suffer a recurrent bout of CDI are at a significantly higher risk for further infections.
Following the first recurrence, up to two-thirds of patients may experience a subsequent recurrence. Antibiotics used to treat CDI may contribute to a cycle of recurrence by altering the gut flora. The administration of fecal microbiota helps restore the gut flora to prevent further episodes of CDI.
“This is a major milestone in the translation of gut microbiome science to clinical solutions for patients,” Phillip I. Tarr, MD, chair of the American Gastroenterological Association’s Center for Gut Microbiome Research and Education Scientific Advisory Board, said in a written statement issued by the AGA. “This accomplishment is based on decades of work on the gut microbiome by gastroenterologists and collaborators. AGA applauds FDA for recognizing the demonstrated and conceptual merit of microbiota-based therapies.”
Rebyota is a microbiota-based live biotherapeutic prepared from human stool collected from prescreened, qualified donors. It comes prepackaged in a single dose that is administered rectally.
The safety and efficacy of Rebyota were assessed in five clinical trials with more than 1,000 participants, the company notes in a press release.
In one trial, following a standard course of antibiotics, a one-time treatment with Rebyota was successful for three-quarters of participants at 8 weeks.
The treatment also prevented additional bouts; 84% of these initial responders remaining free of CDI at 6 months.
Two-thirds of participants reported treatment-emergent adverse events. Most events were mild to moderate in severity. Diarrhea and abdominal pain were the most common.
The data, from the ongoing PUNCH CD3-OLS study, were presented in October at the annual meeting of the American College of Gastroenterology and were published simultaneously in the journal Drugs.
“This is a positive adjunct to our current therapies for C. difficile in terms of trying to knock it out once a standard course of antibiotics has been administered,” Lisa Malter, MD, a gastroenterologist and professor of medicine at New York University Langone Health, said in an interview.
Dr. Malter acknowledged that, because it’s delivered rectally, there could be “some hesitation” on the patient’s part to undergo the therapy.
However, C. difficile can be “excruciating” for patients, and they “may be more than willing to take [this agent] because it gets them feeling better,” said Dr. Malter said, who reported no relevant financial relationships.
The AGA will continue to follow the long-term effectiveness and safety of patients receiving Rebyota, fecal microbiota transplant, and other microbiota-based therapies through its FMT National Registry, according to the AGA statement.
Full prescribing information for Rebyota is available online.
For more information about CDI and FMT, visit patient.gastro.org.
Florida doc dies by suicide after allegedly drugging and raping patients
according to a police statement.
A week later, a Collier County Sheriff’s deputy found Dr. Salata’s body near his Naples home with a gunshot wound to the head, according to police. The medical examiner later ruled it a suicide.
Dr. Salata co-owned Pura Vida Medical Spa in Naples with his wife Jill Salata, a certified family nurse practitioner. They specialized in cosmetic treatment and surgery.
Naples police said that they arrested Dr. Salata after two female patients accused the doctor of allegedly drugging and raping them while they were still unconscious.
Both victims described being given nitrous oxide, also called laughing gas, for sedation and pain from the cosmetic procedure. The first victim, age 51, said Dr. Salata prescribed alprazolam (Xanax) to take before the procedure and then also gave her nitrous oxide and tequila, causing her to black out, according to NBC2 News.
The second victim, age 72, told police that as the nitrous oxide was wearing off, she found Dr. Salata performing sexual intercourse. The victim felt shocked after the sedation subsided about what had taken place, contacted police, and submitted to a sexual assault examination, according to the police statement.
At Dr. Salata’s November 22 hearing before Judge Michael Provost, a prosecutor asked the judge whether Dr. Salata should surrender his firearms; Provost reportedly dismissed the idea.
“It is disappointing and frustrating that Dr. Salata has escaped justice,” said one victim’s attorney, Adam Horowitz, in a blog post. “Yet, we are relieved that no other women will be assaulted by Dr. Salata again. It took tremendous courage for my client to tell her truth. She was ready to hold him accountable in court.”
Horowitz says he plans to file a civil lawsuit on behalf of his client against Dr. Salata’s estate. The Naples police are continuing their investigation into the victims’ cases, which now includes a third woman, said spokesman Lt. Bryan McGinn.
Meanwhile, the Pura Vida Medical Spa has closed permanently and its website has been deleted. One reviewer named Soul F. wrote on the spa’s Yelp page: “And now may God have mercy on this rapist’s soul. Amen.”
A version of this article first appeared on Medscape.com.
according to a police statement.
A week later, a Collier County Sheriff’s deputy found Dr. Salata’s body near his Naples home with a gunshot wound to the head, according to police. The medical examiner later ruled it a suicide.
Dr. Salata co-owned Pura Vida Medical Spa in Naples with his wife Jill Salata, a certified family nurse practitioner. They specialized in cosmetic treatment and surgery.
Naples police said that they arrested Dr. Salata after two female patients accused the doctor of allegedly drugging and raping them while they were still unconscious.
Both victims described being given nitrous oxide, also called laughing gas, for sedation and pain from the cosmetic procedure. The first victim, age 51, said Dr. Salata prescribed alprazolam (Xanax) to take before the procedure and then also gave her nitrous oxide and tequila, causing her to black out, according to NBC2 News.
The second victim, age 72, told police that as the nitrous oxide was wearing off, she found Dr. Salata performing sexual intercourse. The victim felt shocked after the sedation subsided about what had taken place, contacted police, and submitted to a sexual assault examination, according to the police statement.
At Dr. Salata’s November 22 hearing before Judge Michael Provost, a prosecutor asked the judge whether Dr. Salata should surrender his firearms; Provost reportedly dismissed the idea.
“It is disappointing and frustrating that Dr. Salata has escaped justice,” said one victim’s attorney, Adam Horowitz, in a blog post. “Yet, we are relieved that no other women will be assaulted by Dr. Salata again. It took tremendous courage for my client to tell her truth. She was ready to hold him accountable in court.”
Horowitz says he plans to file a civil lawsuit on behalf of his client against Dr. Salata’s estate. The Naples police are continuing their investigation into the victims’ cases, which now includes a third woman, said spokesman Lt. Bryan McGinn.
Meanwhile, the Pura Vida Medical Spa has closed permanently and its website has been deleted. One reviewer named Soul F. wrote on the spa’s Yelp page: “And now may God have mercy on this rapist’s soul. Amen.”
A version of this article first appeared on Medscape.com.
according to a police statement.
A week later, a Collier County Sheriff’s deputy found Dr. Salata’s body near his Naples home with a gunshot wound to the head, according to police. The medical examiner later ruled it a suicide.
Dr. Salata co-owned Pura Vida Medical Spa in Naples with his wife Jill Salata, a certified family nurse practitioner. They specialized in cosmetic treatment and surgery.
Naples police said that they arrested Dr. Salata after two female patients accused the doctor of allegedly drugging and raping them while they were still unconscious.
Both victims described being given nitrous oxide, also called laughing gas, for sedation and pain from the cosmetic procedure. The first victim, age 51, said Dr. Salata prescribed alprazolam (Xanax) to take before the procedure and then also gave her nitrous oxide and tequila, causing her to black out, according to NBC2 News.
The second victim, age 72, told police that as the nitrous oxide was wearing off, she found Dr. Salata performing sexual intercourse. The victim felt shocked after the sedation subsided about what had taken place, contacted police, and submitted to a sexual assault examination, according to the police statement.
At Dr. Salata’s November 22 hearing before Judge Michael Provost, a prosecutor asked the judge whether Dr. Salata should surrender his firearms; Provost reportedly dismissed the idea.
“It is disappointing and frustrating that Dr. Salata has escaped justice,” said one victim’s attorney, Adam Horowitz, in a blog post. “Yet, we are relieved that no other women will be assaulted by Dr. Salata again. It took tremendous courage for my client to tell her truth. She was ready to hold him accountable in court.”
Horowitz says he plans to file a civil lawsuit on behalf of his client against Dr. Salata’s estate. The Naples police are continuing their investigation into the victims’ cases, which now includes a third woman, said spokesman Lt. Bryan McGinn.
Meanwhile, the Pura Vida Medical Spa has closed permanently and its website has been deleted. One reviewer named Soul F. wrote on the spa’s Yelp page: “And now may God have mercy on this rapist’s soul. Amen.”
A version of this article first appeared on Medscape.com.
Visualization can improve sports performance
Over the past 30 years, Dr. Richard W. Cohen has used visualization techniques to help world class tennis players and recreational tennis players become the best they could be.
Visualization should be used in two ways to help players improve. First, to improve technique, after every practice session I have the player think about one shot they did not do well technically, and I have them, in vivo, shadow the shot on the court correctly before they leave the court. That night I tell the player to put themselves in a quiet, relaxed place and, in vitro, visualize themselves hitting the shot the correct way.
Almost always, the next day the players tell me they are hitting that one shot better and are motivated to again think about the one shot that was not technically correct and repeat the in vivo technique with similar great results.
The second way I use visualization for tennis players is to decrease their anxiety before matches. It is important to have some preparatory anxiety to perform optimally but having excessive anxiety will decrease performance. To alleviate excessive anxiety before matches, I have players watch their opponents hit the day before the match for at least 5 minutes to see their strengths and weaknesses. Then, the night before the match, I have them visualize how they will play a big point utilizing their strength into their opponent’s weakness. This rehearsal using imagery the night before a big match will decrease a player’s excessive anxiety and allow them to achieve their best effort in the match.
An example of this is if their opponent has a weak backhand that they can only slice. They visualize hitting wide to their forehand to get into their weak backhand and see themselves going forward and putting away a volley. Visualization used in these two ways helps improve stroke mechanics and match results in players of all levels. These visualization techniques can also be extended to other sports and to help improve life habits.
For example, Dr. Susan A. Cohen has seen that many patients have a decline in their dental health because of fear of going to the dentist to receive the treatment they need. Visualization techniques decrease the patient’s anxiety by rehearsing the possible traumatic events of the dental visit – e.g., the injection of anesthesia before the dental procedure. Visualization of calmness with systematic desensitization has helped decrease anxiety in patients.
In 20 years of clinical experience as a dentist, Dr. Cohen has seen how these techniques have increased compliance in her dental patients. She has also noted that visualizing the results of having a healthy mouth with improved appearance and function leads to an overall willingness to visit the dentist regularly and enjoy the dental experience. These examples demonstrate how visualization can enhance sports performance, quality of life, and overall health.
Dr. Richard W. Cohen is a psychiatrist who has been in private practice for over 40 years and is on the editorial advisory board for Clinical Psychiatry News. He has won 18 USTA national tennis championships. Dr. Susan A. Cohen has practiced dentistry for over 20 years. The Cohens, who are married, are based in Philadelphia.
Over the past 30 years, Dr. Richard W. Cohen has used visualization techniques to help world class tennis players and recreational tennis players become the best they could be.
Visualization should be used in two ways to help players improve. First, to improve technique, after every practice session I have the player think about one shot they did not do well technically, and I have them, in vivo, shadow the shot on the court correctly before they leave the court. That night I tell the player to put themselves in a quiet, relaxed place and, in vitro, visualize themselves hitting the shot the correct way.
Almost always, the next day the players tell me they are hitting that one shot better and are motivated to again think about the one shot that was not technically correct and repeat the in vivo technique with similar great results.
The second way I use visualization for tennis players is to decrease their anxiety before matches. It is important to have some preparatory anxiety to perform optimally but having excessive anxiety will decrease performance. To alleviate excessive anxiety before matches, I have players watch their opponents hit the day before the match for at least 5 minutes to see their strengths and weaknesses. Then, the night before the match, I have them visualize how they will play a big point utilizing their strength into their opponent’s weakness. This rehearsal using imagery the night before a big match will decrease a player’s excessive anxiety and allow them to achieve their best effort in the match.
An example of this is if their opponent has a weak backhand that they can only slice. They visualize hitting wide to their forehand to get into their weak backhand and see themselves going forward and putting away a volley. Visualization used in these two ways helps improve stroke mechanics and match results in players of all levels. These visualization techniques can also be extended to other sports and to help improve life habits.
For example, Dr. Susan A. Cohen has seen that many patients have a decline in their dental health because of fear of going to the dentist to receive the treatment they need. Visualization techniques decrease the patient’s anxiety by rehearsing the possible traumatic events of the dental visit – e.g., the injection of anesthesia before the dental procedure. Visualization of calmness with systematic desensitization has helped decrease anxiety in patients.
In 20 years of clinical experience as a dentist, Dr. Cohen has seen how these techniques have increased compliance in her dental patients. She has also noted that visualizing the results of having a healthy mouth with improved appearance and function leads to an overall willingness to visit the dentist regularly and enjoy the dental experience. These examples demonstrate how visualization can enhance sports performance, quality of life, and overall health.
Dr. Richard W. Cohen is a psychiatrist who has been in private practice for over 40 years and is on the editorial advisory board for Clinical Psychiatry News. He has won 18 USTA national tennis championships. Dr. Susan A. Cohen has practiced dentistry for over 20 years. The Cohens, who are married, are based in Philadelphia.
Over the past 30 years, Dr. Richard W. Cohen has used visualization techniques to help world class tennis players and recreational tennis players become the best they could be.
Visualization should be used in two ways to help players improve. First, to improve technique, after every practice session I have the player think about one shot they did not do well technically, and I have them, in vivo, shadow the shot on the court correctly before they leave the court. That night I tell the player to put themselves in a quiet, relaxed place and, in vitro, visualize themselves hitting the shot the correct way.
Almost always, the next day the players tell me they are hitting that one shot better and are motivated to again think about the one shot that was not technically correct and repeat the in vivo technique with similar great results.
The second way I use visualization for tennis players is to decrease their anxiety before matches. It is important to have some preparatory anxiety to perform optimally but having excessive anxiety will decrease performance. To alleviate excessive anxiety before matches, I have players watch their opponents hit the day before the match for at least 5 minutes to see their strengths and weaknesses. Then, the night before the match, I have them visualize how they will play a big point utilizing their strength into their opponent’s weakness. This rehearsal using imagery the night before a big match will decrease a player’s excessive anxiety and allow them to achieve their best effort in the match.
An example of this is if their opponent has a weak backhand that they can only slice. They visualize hitting wide to their forehand to get into their weak backhand and see themselves going forward and putting away a volley. Visualization used in these two ways helps improve stroke mechanics and match results in players of all levels. These visualization techniques can also be extended to other sports and to help improve life habits.
For example, Dr. Susan A. Cohen has seen that many patients have a decline in their dental health because of fear of going to the dentist to receive the treatment they need. Visualization techniques decrease the patient’s anxiety by rehearsing the possible traumatic events of the dental visit – e.g., the injection of anesthesia before the dental procedure. Visualization of calmness with systematic desensitization has helped decrease anxiety in patients.
In 20 years of clinical experience as a dentist, Dr. Cohen has seen how these techniques have increased compliance in her dental patients. She has also noted that visualizing the results of having a healthy mouth with improved appearance and function leads to an overall willingness to visit the dentist regularly and enjoy the dental experience. These examples demonstrate how visualization can enhance sports performance, quality of life, and overall health.
Dr. Richard W. Cohen is a psychiatrist who has been in private practice for over 40 years and is on the editorial advisory board for Clinical Psychiatry News. He has won 18 USTA national tennis championships. Dr. Susan A. Cohen has practiced dentistry for over 20 years. The Cohens, who are married, are based in Philadelphia.
What are the risk factors for Mohs surgery–related anxiety?
confirmed by a health care provider (HCP), results from a single-center survey demonstrated.
“Higher patient-reported anxiety in hospital settings is significantly linked to lower patient satisfaction with the quality of care and higher patient-reported postoperative pain,” corresponding author Ally-Khan Somani, MD, PhD, and colleagues wrote in the study, which was published online in Dermatologic Surgery. “Identifying factors associated with perioperative patient anxiety could improve outcomes and patient satisfaction.”
Dr. Somani, director of dermatologic surgery and cutaneous oncology in the department of dermatology at the University of Indiana, Indianapolis, and coauthors surveyed 145 patients who underwent Mohs micrographic surgery (MMS) at the university from February 2018 to March 2020. They collected patient self-reported demographics, medical history, and administered a 10-point visual analog scale assessment of anxiety at multiple stages. They also sought HCP-perceived assessments of anxiety and used a stepwise regression mode to explore factors that potentially contributed to anxiety outcomes. The mean age of the 145 patients was 63 years, 60% were female, and 77% had no self-reported anxiety confirmed by a prior HCP’s diagnosis.
Two-thirds of patients (66%) received a pre-MMS consultation with the surgeon, 59% had a history of skin cancer removal surgery, and 86% had 1-2 layers removed during the current MMS.
Prior to MMS, the researchers found that significant risk factors for increased anxiety included younger age, female sex, and self-reported history of anxiety confirmed by an HCP (P < .05), while intraoperatively, HCP-perceived patient anxiety increased with younger patient age and more layers removed. Following MMS, patient anxiety increased significantly with more layers removed and higher self-reported preoperative anxiety levels. “Although existing research is divided regarding the efficacy of pre-MMS consultation for anxiety reduction, these findings suggest that patient-reported and HCP-perceived anxiety were not significantly affected by in-person pre-MMS consultation with the surgeon,” Dr. Somani and colleagues wrote. “Thus, routinely recommending consultations may not be the best approach for improving anxiety outcomes.”
They acknowledged certain limitations of their analysis, including its single-center design, enrollment of demographically similar patients, and the fact that no objective measurements of anxiety such as heart rate or blood pressure were taken.
“One of the main benefits of Mohs surgery is that we are able to operate under local anesthesia, but this also means that our patients are acutely aware of everything going on around them,” said Patricia M. Richey, MD, who practices Mohs surgery and cosmetic dermatology in Washington, D.C., and was asked to comment on the study.
“I think it is so important that this study is primarily focusing on the patient experience,” she said. “While this study did not find that a pre-op consult impacted patient anxiety levels, I do think we can infer that it is critical to connect with your patients on some level prior to surgery, as it helps you tailor your process to make the day more tolerable for them [such as] playing music, determining the need for an oral anxiolytic, etc.”
Neither the researchers nor Dr. Richey reported having financial disclosures.
confirmed by a health care provider (HCP), results from a single-center survey demonstrated.
“Higher patient-reported anxiety in hospital settings is significantly linked to lower patient satisfaction with the quality of care and higher patient-reported postoperative pain,” corresponding author Ally-Khan Somani, MD, PhD, and colleagues wrote in the study, which was published online in Dermatologic Surgery. “Identifying factors associated with perioperative patient anxiety could improve outcomes and patient satisfaction.”
Dr. Somani, director of dermatologic surgery and cutaneous oncology in the department of dermatology at the University of Indiana, Indianapolis, and coauthors surveyed 145 patients who underwent Mohs micrographic surgery (MMS) at the university from February 2018 to March 2020. They collected patient self-reported demographics, medical history, and administered a 10-point visual analog scale assessment of anxiety at multiple stages. They also sought HCP-perceived assessments of anxiety and used a stepwise regression mode to explore factors that potentially contributed to anxiety outcomes. The mean age of the 145 patients was 63 years, 60% were female, and 77% had no self-reported anxiety confirmed by a prior HCP’s diagnosis.
Two-thirds of patients (66%) received a pre-MMS consultation with the surgeon, 59% had a history of skin cancer removal surgery, and 86% had 1-2 layers removed during the current MMS.
Prior to MMS, the researchers found that significant risk factors for increased anxiety included younger age, female sex, and self-reported history of anxiety confirmed by an HCP (P < .05), while intraoperatively, HCP-perceived patient anxiety increased with younger patient age and more layers removed. Following MMS, patient anxiety increased significantly with more layers removed and higher self-reported preoperative anxiety levels. “Although existing research is divided regarding the efficacy of pre-MMS consultation for anxiety reduction, these findings suggest that patient-reported and HCP-perceived anxiety were not significantly affected by in-person pre-MMS consultation with the surgeon,” Dr. Somani and colleagues wrote. “Thus, routinely recommending consultations may not be the best approach for improving anxiety outcomes.”
They acknowledged certain limitations of their analysis, including its single-center design, enrollment of demographically similar patients, and the fact that no objective measurements of anxiety such as heart rate or blood pressure were taken.
“One of the main benefits of Mohs surgery is that we are able to operate under local anesthesia, but this also means that our patients are acutely aware of everything going on around them,” said Patricia M. Richey, MD, who practices Mohs surgery and cosmetic dermatology in Washington, D.C., and was asked to comment on the study.
“I think it is so important that this study is primarily focusing on the patient experience,” she said. “While this study did not find that a pre-op consult impacted patient anxiety levels, I do think we can infer that it is critical to connect with your patients on some level prior to surgery, as it helps you tailor your process to make the day more tolerable for them [such as] playing music, determining the need for an oral anxiolytic, etc.”
Neither the researchers nor Dr. Richey reported having financial disclosures.
confirmed by a health care provider (HCP), results from a single-center survey demonstrated.
“Higher patient-reported anxiety in hospital settings is significantly linked to lower patient satisfaction with the quality of care and higher patient-reported postoperative pain,” corresponding author Ally-Khan Somani, MD, PhD, and colleagues wrote in the study, which was published online in Dermatologic Surgery. “Identifying factors associated with perioperative patient anxiety could improve outcomes and patient satisfaction.”
Dr. Somani, director of dermatologic surgery and cutaneous oncology in the department of dermatology at the University of Indiana, Indianapolis, and coauthors surveyed 145 patients who underwent Mohs micrographic surgery (MMS) at the university from February 2018 to March 2020. They collected patient self-reported demographics, medical history, and administered a 10-point visual analog scale assessment of anxiety at multiple stages. They also sought HCP-perceived assessments of anxiety and used a stepwise regression mode to explore factors that potentially contributed to anxiety outcomes. The mean age of the 145 patients was 63 years, 60% were female, and 77% had no self-reported anxiety confirmed by a prior HCP’s diagnosis.
Two-thirds of patients (66%) received a pre-MMS consultation with the surgeon, 59% had a history of skin cancer removal surgery, and 86% had 1-2 layers removed during the current MMS.
Prior to MMS, the researchers found that significant risk factors for increased anxiety included younger age, female sex, and self-reported history of anxiety confirmed by an HCP (P < .05), while intraoperatively, HCP-perceived patient anxiety increased with younger patient age and more layers removed. Following MMS, patient anxiety increased significantly with more layers removed and higher self-reported preoperative anxiety levels. “Although existing research is divided regarding the efficacy of pre-MMS consultation for anxiety reduction, these findings suggest that patient-reported and HCP-perceived anxiety were not significantly affected by in-person pre-MMS consultation with the surgeon,” Dr. Somani and colleagues wrote. “Thus, routinely recommending consultations may not be the best approach for improving anxiety outcomes.”
They acknowledged certain limitations of their analysis, including its single-center design, enrollment of demographically similar patients, and the fact that no objective measurements of anxiety such as heart rate or blood pressure were taken.
“One of the main benefits of Mohs surgery is that we are able to operate under local anesthesia, but this also means that our patients are acutely aware of everything going on around them,” said Patricia M. Richey, MD, who practices Mohs surgery and cosmetic dermatology in Washington, D.C., and was asked to comment on the study.
“I think it is so important that this study is primarily focusing on the patient experience,” she said. “While this study did not find that a pre-op consult impacted patient anxiety levels, I do think we can infer that it is critical to connect with your patients on some level prior to surgery, as it helps you tailor your process to make the day more tolerable for them [such as] playing music, determining the need for an oral anxiolytic, etc.”
Neither the researchers nor Dr. Richey reported having financial disclosures.
FROM DERMATOLOGIC SURGERY
Overdose deaths up 81% in pregnant, postpartum women
Drug overdose deaths in pregnant and postpartum women rose by about 81% from 2017 to 2020, researchers report in a JAMA research letter published online Dec. 6.
Pregnancy-associated overdose deaths were highest in 2020 as the COVID pandemic began, according to the researchers, Emilie Bruzelius, MPH, and Silvia S. Martins, MD, PHD, with the department of epidemiology, Columbia University School of Public Health in New York.
The deaths were identified using International Statistical Classification of Diseases and Related Health Problems (ICD-10) pregnancy-related codes and death certificate pregnancy checkbox status.
The checkbox, part of all states’ death certificates, asks whether the person was pregnant at the time of death, within 42 days of death (early postpartum) or within 43-365 days of death (late postpartum).
Sharp increase at start of COVID pandemic
The authors note that pregnancy-related overdose deaths have been climbing from 2007 to 2019, but increased sharply in 2020.
“Pregnant and postpartum persons are known to face barriers to accessing drug treatment and harm-reduction services, which when compounded by pandemic-associated stressors, health care shutdowns, and increasingly volatile unregulated drug supply may have increased fatal overdose risk,” the authors write.
Of the 7,642 pregnancy-related deaths in the study period, 1,249 were overdose-related, leading to a cumulative overdose death rate of 8.35 per 100,000. From 2017 to 2020, pregnancy-related overdose deaths rose from 6.56 to 11.85 per 100,000. That translates to an absolute change rate of 5.30 per 100,000 and a relative increase of 81%.
The trend mirrors a pattern in people of reproductive age overall, the authors write.
Overdose mortality among reproductive age women similarly increased from 14.37 to 19.76 per 100,000 (absolute change rate, 5.39 [95% confidence interval, 4.94-5.85] per 100,000; relative increase of 38%).
Fentanyl deaths increase
The researchers found large increases in deaths involving fentanyl and other synthetics and psychostimulants (methamphetamine and cocaine, for example).
Pregnancy-associated overdose deaths involving benzodiazepines, heroin, and prescription opioids, however, were mostly stable from 2017 to 2020.
Numbers of late postpartum overdose deaths were notable in the paper.
In that group, there were 3.95 deaths per 100,000, compared with those pregnant at the time of death (2.99 per 100,000 or those identified as early postpartum (1.39 per 100 000).
Davida Schiff, MD, director of the Perinatal and Family-based Substance Use Disorder Care Massachusetts General Hospital substance use disorders initiative in Boston, told this publication it’s important to realize from this study that late postpartum period is the highest-risk period and also the time “when many states that have not expanded Medicaid cut off insurance needed to access life-saving health care services.”“Pregnancy is an important touch point of increased health care access, yet pregnant and parenting people face unique social and legal consequences from their substance use,” Dr. Schiff said.
She added, “I’m left wondering how many of the deaths reported could have been avoided if fear of a punitive response when engaging with our health care system had not prevented them from seeking out the care they needed.”
Dr. Schiff said the study highlights the importance of the pregnancy-checkbox addition to death records to better characterize pregnancy-associated deaths that previously were likely undercounted.
The authors and Dr. Schiff declare no relevant financial relationships.
Drug overdose deaths in pregnant and postpartum women rose by about 81% from 2017 to 2020, researchers report in a JAMA research letter published online Dec. 6.
Pregnancy-associated overdose deaths were highest in 2020 as the COVID pandemic began, according to the researchers, Emilie Bruzelius, MPH, and Silvia S. Martins, MD, PHD, with the department of epidemiology, Columbia University School of Public Health in New York.
The deaths were identified using International Statistical Classification of Diseases and Related Health Problems (ICD-10) pregnancy-related codes and death certificate pregnancy checkbox status.
The checkbox, part of all states’ death certificates, asks whether the person was pregnant at the time of death, within 42 days of death (early postpartum) or within 43-365 days of death (late postpartum).
Sharp increase at start of COVID pandemic
The authors note that pregnancy-related overdose deaths have been climbing from 2007 to 2019, but increased sharply in 2020.
“Pregnant and postpartum persons are known to face barriers to accessing drug treatment and harm-reduction services, which when compounded by pandemic-associated stressors, health care shutdowns, and increasingly volatile unregulated drug supply may have increased fatal overdose risk,” the authors write.
Of the 7,642 pregnancy-related deaths in the study period, 1,249 were overdose-related, leading to a cumulative overdose death rate of 8.35 per 100,000. From 2017 to 2020, pregnancy-related overdose deaths rose from 6.56 to 11.85 per 100,000. That translates to an absolute change rate of 5.30 per 100,000 and a relative increase of 81%.
The trend mirrors a pattern in people of reproductive age overall, the authors write.
Overdose mortality among reproductive age women similarly increased from 14.37 to 19.76 per 100,000 (absolute change rate, 5.39 [95% confidence interval, 4.94-5.85] per 100,000; relative increase of 38%).
Fentanyl deaths increase
The researchers found large increases in deaths involving fentanyl and other synthetics and psychostimulants (methamphetamine and cocaine, for example).
Pregnancy-associated overdose deaths involving benzodiazepines, heroin, and prescription opioids, however, were mostly stable from 2017 to 2020.
Numbers of late postpartum overdose deaths were notable in the paper.
In that group, there were 3.95 deaths per 100,000, compared with those pregnant at the time of death (2.99 per 100,000 or those identified as early postpartum (1.39 per 100 000).
Davida Schiff, MD, director of the Perinatal and Family-based Substance Use Disorder Care Massachusetts General Hospital substance use disorders initiative in Boston, told this publication it’s important to realize from this study that late postpartum period is the highest-risk period and also the time “when many states that have not expanded Medicaid cut off insurance needed to access life-saving health care services.”“Pregnancy is an important touch point of increased health care access, yet pregnant and parenting people face unique social and legal consequences from their substance use,” Dr. Schiff said.
She added, “I’m left wondering how many of the deaths reported could have been avoided if fear of a punitive response when engaging with our health care system had not prevented them from seeking out the care they needed.”
Dr. Schiff said the study highlights the importance of the pregnancy-checkbox addition to death records to better characterize pregnancy-associated deaths that previously were likely undercounted.
The authors and Dr. Schiff declare no relevant financial relationships.
Drug overdose deaths in pregnant and postpartum women rose by about 81% from 2017 to 2020, researchers report in a JAMA research letter published online Dec. 6.
Pregnancy-associated overdose deaths were highest in 2020 as the COVID pandemic began, according to the researchers, Emilie Bruzelius, MPH, and Silvia S. Martins, MD, PHD, with the department of epidemiology, Columbia University School of Public Health in New York.
The deaths were identified using International Statistical Classification of Diseases and Related Health Problems (ICD-10) pregnancy-related codes and death certificate pregnancy checkbox status.
The checkbox, part of all states’ death certificates, asks whether the person was pregnant at the time of death, within 42 days of death (early postpartum) or within 43-365 days of death (late postpartum).
Sharp increase at start of COVID pandemic
The authors note that pregnancy-related overdose deaths have been climbing from 2007 to 2019, but increased sharply in 2020.
“Pregnant and postpartum persons are known to face barriers to accessing drug treatment and harm-reduction services, which when compounded by pandemic-associated stressors, health care shutdowns, and increasingly volatile unregulated drug supply may have increased fatal overdose risk,” the authors write.
Of the 7,642 pregnancy-related deaths in the study period, 1,249 were overdose-related, leading to a cumulative overdose death rate of 8.35 per 100,000. From 2017 to 2020, pregnancy-related overdose deaths rose from 6.56 to 11.85 per 100,000. That translates to an absolute change rate of 5.30 per 100,000 and a relative increase of 81%.
The trend mirrors a pattern in people of reproductive age overall, the authors write.
Overdose mortality among reproductive age women similarly increased from 14.37 to 19.76 per 100,000 (absolute change rate, 5.39 [95% confidence interval, 4.94-5.85] per 100,000; relative increase of 38%).
Fentanyl deaths increase
The researchers found large increases in deaths involving fentanyl and other synthetics and psychostimulants (methamphetamine and cocaine, for example).
Pregnancy-associated overdose deaths involving benzodiazepines, heroin, and prescription opioids, however, were mostly stable from 2017 to 2020.
Numbers of late postpartum overdose deaths were notable in the paper.
In that group, there were 3.95 deaths per 100,000, compared with those pregnant at the time of death (2.99 per 100,000 or those identified as early postpartum (1.39 per 100 000).
Davida Schiff, MD, director of the Perinatal and Family-based Substance Use Disorder Care Massachusetts General Hospital substance use disorders initiative in Boston, told this publication it’s important to realize from this study that late postpartum period is the highest-risk period and also the time “when many states that have not expanded Medicaid cut off insurance needed to access life-saving health care services.”“Pregnancy is an important touch point of increased health care access, yet pregnant and parenting people face unique social and legal consequences from their substance use,” Dr. Schiff said.
She added, “I’m left wondering how many of the deaths reported could have been avoided if fear of a punitive response when engaging with our health care system had not prevented them from seeking out the care they needed.”
Dr. Schiff said the study highlights the importance of the pregnancy-checkbox addition to death records to better characterize pregnancy-associated deaths that previously were likely undercounted.
The authors and Dr. Schiff declare no relevant financial relationships.
FROM JAMA