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AHA: Quality of STEMI care has stalled, needs improvement
Following up on its 2007 initiative to improve care for people who have ST-segment elevation myocardial infarction (STEMI), the American Heart Association has issued a policy statement that includes a host of recommendations to further overcome barriers to optimal care for this most severe type of heart attack.
The statement recommends steps for designing what the writing committee calls “the ideal STEMI system of care” for patients who have these severe heart attacks.
The focus of the policy statement is the AHA’s Mission: Lifeline national initiative to coordinate and improve the quality of care to patients with STEMI, which was introduced in 2007. Since then, the number or participating hospitals has increased from 485 to 857, now covering more than 85% of the U.S. population, noted the new statement, published online in Circulation.
“Bringing STEMI referring hospitals, STEMI receiving centers and emergency medical services [EMS] together in the development of local and regional systems of care within the AHA’s Mission: Lifeline program has led to significant improvement in time to treatment and outcomes for patients with STEMI,” Alice K. Jacobs, MD, lead statement author and vice chair for clinical affairs in the department of medicine at Boston Medical Center and a professor at Boston University, said in an interview.
“Yet,” Dr. Jacobs added, “opportunities exist to further improve the coordination of care and address remaining barriers to providing ideal care. Moreover, Mission: Lifeline systems of care have been extended to other time-sensitive cardiovascular disorders including stroke and out-of-hospital cardiac arrest.”
The statement itself noted, “Although there have been significant improvements in patients with STEMI receiving guideline-recommended care, progress has slowed during the past few years.” From 2008 to 2012, a number of key quality care measures at participating hospitals had improved markedly. For example, door-in-door-out (DIDO) transfers improved from a median of 76 to 62 minutes (P < .001).
However, from 2012 to 2019, with more hospitals participating, while many key measures improved, a few either plateaued or worsened slightly. Median DIDO time, for example – again, with more hospitals participating, compared with the earlier dataset – went from 45 in 2012 to 48 in 2019, according to AHA data.
Key recommendations aim to impact and improve hospital care for patients with STEMI, Dr. Jacobs said. “In addition to avoiding patient delay at the onset of recognized symptoms of a heart attack, accessing 911 and following EMS destination protocols, the prehospital activation of the cardiac catheterization lab and providing a 911 response for interhospital transport as well as direct-to-cardiac-catheterization-lab transport bypassing the emergency department when appropriate would all impact and improve hospital care.”
Other key recommendations of the statement include:
- Increasing public awareness of heart attack signs and symptoms and the importance for calling 911.
- Addressing post-MI care, including use of evidence-based practices for cardiac rehabilitation and even getting insurance companies to encourage cardiac rehab through incentives.
- Engaging rural hospitals by leveraging telemedicine to expedite percutaneous coronary intervention (PCI) and by developing systems for treatment protocols and rapid transport among facilities.
- Tearing down financial barriers with a global reimbursement model that encompasses each stop in a patient’s journey through the care system: the referring hospital, receiving center, EMS transport and transfer, and ancillary services.
The statement also took into account improving disparities in the quality of care women with STEMI receive. “It has been reported that women with STEMI may have less typical symptoms than men and arrive later [delay longer] than men after symptom onset,” Dr. Jacobs said. “Educating the public and all members of the health-care team about issues specific to women will be helpful in improving care in women. Of note, STEMI systems of care have been shown to reduce sex and age disparities in care.”
The statement also addressed implications of the COVID-19 pandemic, stating that PCI should remain the dominant treatment for patients with classic STEMI. “Patients must be reassured that appropriate precautions have been implemented by EMS and hospital to protect them and health care workers from COVID-19 infection,” the statement noted.
Dr. Jacobs has no relevant relationships to disclose.
Following up on its 2007 initiative to improve care for people who have ST-segment elevation myocardial infarction (STEMI), the American Heart Association has issued a policy statement that includes a host of recommendations to further overcome barriers to optimal care for this most severe type of heart attack.
The statement recommends steps for designing what the writing committee calls “the ideal STEMI system of care” for patients who have these severe heart attacks.
The focus of the policy statement is the AHA’s Mission: Lifeline national initiative to coordinate and improve the quality of care to patients with STEMI, which was introduced in 2007. Since then, the number or participating hospitals has increased from 485 to 857, now covering more than 85% of the U.S. population, noted the new statement, published online in Circulation.
“Bringing STEMI referring hospitals, STEMI receiving centers and emergency medical services [EMS] together in the development of local and regional systems of care within the AHA’s Mission: Lifeline program has led to significant improvement in time to treatment and outcomes for patients with STEMI,” Alice K. Jacobs, MD, lead statement author and vice chair for clinical affairs in the department of medicine at Boston Medical Center and a professor at Boston University, said in an interview.
“Yet,” Dr. Jacobs added, “opportunities exist to further improve the coordination of care and address remaining barriers to providing ideal care. Moreover, Mission: Lifeline systems of care have been extended to other time-sensitive cardiovascular disorders including stroke and out-of-hospital cardiac arrest.”
The statement itself noted, “Although there have been significant improvements in patients with STEMI receiving guideline-recommended care, progress has slowed during the past few years.” From 2008 to 2012, a number of key quality care measures at participating hospitals had improved markedly. For example, door-in-door-out (DIDO) transfers improved from a median of 76 to 62 minutes (P < .001).
However, from 2012 to 2019, with more hospitals participating, while many key measures improved, a few either plateaued or worsened slightly. Median DIDO time, for example – again, with more hospitals participating, compared with the earlier dataset – went from 45 in 2012 to 48 in 2019, according to AHA data.
Key recommendations aim to impact and improve hospital care for patients with STEMI, Dr. Jacobs said. “In addition to avoiding patient delay at the onset of recognized symptoms of a heart attack, accessing 911 and following EMS destination protocols, the prehospital activation of the cardiac catheterization lab and providing a 911 response for interhospital transport as well as direct-to-cardiac-catheterization-lab transport bypassing the emergency department when appropriate would all impact and improve hospital care.”
Other key recommendations of the statement include:
- Increasing public awareness of heart attack signs and symptoms and the importance for calling 911.
- Addressing post-MI care, including use of evidence-based practices for cardiac rehabilitation and even getting insurance companies to encourage cardiac rehab through incentives.
- Engaging rural hospitals by leveraging telemedicine to expedite percutaneous coronary intervention (PCI) and by developing systems for treatment protocols and rapid transport among facilities.
- Tearing down financial barriers with a global reimbursement model that encompasses each stop in a patient’s journey through the care system: the referring hospital, receiving center, EMS transport and transfer, and ancillary services.
The statement also took into account improving disparities in the quality of care women with STEMI receive. “It has been reported that women with STEMI may have less typical symptoms than men and arrive later [delay longer] than men after symptom onset,” Dr. Jacobs said. “Educating the public and all members of the health-care team about issues specific to women will be helpful in improving care in women. Of note, STEMI systems of care have been shown to reduce sex and age disparities in care.”
The statement also addressed implications of the COVID-19 pandemic, stating that PCI should remain the dominant treatment for patients with classic STEMI. “Patients must be reassured that appropriate precautions have been implemented by EMS and hospital to protect them and health care workers from COVID-19 infection,” the statement noted.
Dr. Jacobs has no relevant relationships to disclose.
Following up on its 2007 initiative to improve care for people who have ST-segment elevation myocardial infarction (STEMI), the American Heart Association has issued a policy statement that includes a host of recommendations to further overcome barriers to optimal care for this most severe type of heart attack.
The statement recommends steps for designing what the writing committee calls “the ideal STEMI system of care” for patients who have these severe heart attacks.
The focus of the policy statement is the AHA’s Mission: Lifeline national initiative to coordinate and improve the quality of care to patients with STEMI, which was introduced in 2007. Since then, the number or participating hospitals has increased from 485 to 857, now covering more than 85% of the U.S. population, noted the new statement, published online in Circulation.
“Bringing STEMI referring hospitals, STEMI receiving centers and emergency medical services [EMS] together in the development of local and regional systems of care within the AHA’s Mission: Lifeline program has led to significant improvement in time to treatment and outcomes for patients with STEMI,” Alice K. Jacobs, MD, lead statement author and vice chair for clinical affairs in the department of medicine at Boston Medical Center and a professor at Boston University, said in an interview.
“Yet,” Dr. Jacobs added, “opportunities exist to further improve the coordination of care and address remaining barriers to providing ideal care. Moreover, Mission: Lifeline systems of care have been extended to other time-sensitive cardiovascular disorders including stroke and out-of-hospital cardiac arrest.”
The statement itself noted, “Although there have been significant improvements in patients with STEMI receiving guideline-recommended care, progress has slowed during the past few years.” From 2008 to 2012, a number of key quality care measures at participating hospitals had improved markedly. For example, door-in-door-out (DIDO) transfers improved from a median of 76 to 62 minutes (P < .001).
However, from 2012 to 2019, with more hospitals participating, while many key measures improved, a few either plateaued or worsened slightly. Median DIDO time, for example – again, with more hospitals participating, compared with the earlier dataset – went from 45 in 2012 to 48 in 2019, according to AHA data.
Key recommendations aim to impact and improve hospital care for patients with STEMI, Dr. Jacobs said. “In addition to avoiding patient delay at the onset of recognized symptoms of a heart attack, accessing 911 and following EMS destination protocols, the prehospital activation of the cardiac catheterization lab and providing a 911 response for interhospital transport as well as direct-to-cardiac-catheterization-lab transport bypassing the emergency department when appropriate would all impact and improve hospital care.”
Other key recommendations of the statement include:
- Increasing public awareness of heart attack signs and symptoms and the importance for calling 911.
- Addressing post-MI care, including use of evidence-based practices for cardiac rehabilitation and even getting insurance companies to encourage cardiac rehab through incentives.
- Engaging rural hospitals by leveraging telemedicine to expedite percutaneous coronary intervention (PCI) and by developing systems for treatment protocols and rapid transport among facilities.
- Tearing down financial barriers with a global reimbursement model that encompasses each stop in a patient’s journey through the care system: the referring hospital, receiving center, EMS transport and transfer, and ancillary services.
The statement also took into account improving disparities in the quality of care women with STEMI receive. “It has been reported that women with STEMI may have less typical symptoms than men and arrive later [delay longer] than men after symptom onset,” Dr. Jacobs said. “Educating the public and all members of the health-care team about issues specific to women will be helpful in improving care in women. Of note, STEMI systems of care have been shown to reduce sex and age disparities in care.”
The statement also addressed implications of the COVID-19 pandemic, stating that PCI should remain the dominant treatment for patients with classic STEMI. “Patients must be reassured that appropriate precautions have been implemented by EMS and hospital to protect them and health care workers from COVID-19 infection,” the statement noted.
Dr. Jacobs has no relevant relationships to disclose.
FROM CIRCULATION
FDA OKs new high-dose naloxone product for opioid overdose
ZIMHI from Adamis Pharmaceuticals is administered using a single-dose, prefilled syringe that delivers 5 mg of naloxone hydrochloride solution through intramuscular or subcutaneous injection.
Naloxone is an opioid antagonist that works by blocking or reversing the effects of the opioid, including extreme drowsiness, slowed breathing, or loss of consciousness.
Opioid-related overdose deaths — driven partly by prescription drug overdoses — remain a leading cause of death in the United States.
ZIMHI “provides an additional option in the treatment of opioid overdoses,” the FDA said in a statement announcing approval.
In a statement from Adamis Pharmaceuticals, Jeffrey Galinkin, MD, an anesthesiologist and former member of the FDA advisory committee for analgesics and addiction products, said he is “pleased to see this much-needed, high-dose naloxone product will become part of the treatment tool kit as a countermeasure to the continued surge in fentanyl related deaths.”
“The higher intramuscular doses of naloxone in ZIMHI should result in more rapid and higher levels of naloxone in the systemic circulation, which in turn, should result in more successful resuscitations,” Dr. Galinkin said.
Last spring the FDA approved a higher-dose naloxone hydrochloride nasal spray (Kloxxado) for the emergency treatment of opioid overdose.
Kloxxado delivers 8 mg of naloxone into the nasal cavity, which is twice as much as the 4 mg of naloxone contained in Narcan nasal spray.
The FDA approved ZIMHI (and Kloxxado) through the 505(b)(2) regulatory pathway, which allows the agency to refer to previous findings of safety and efficacy for an already-approved product, as well as to review findings from further studies of the product.
The company plans to launch ZIMHI in the first quarter of 2022.
A version of this article first appeared on Medscape.com.
ZIMHI from Adamis Pharmaceuticals is administered using a single-dose, prefilled syringe that delivers 5 mg of naloxone hydrochloride solution through intramuscular or subcutaneous injection.
Naloxone is an opioid antagonist that works by blocking or reversing the effects of the opioid, including extreme drowsiness, slowed breathing, or loss of consciousness.
Opioid-related overdose deaths — driven partly by prescription drug overdoses — remain a leading cause of death in the United States.
ZIMHI “provides an additional option in the treatment of opioid overdoses,” the FDA said in a statement announcing approval.
In a statement from Adamis Pharmaceuticals, Jeffrey Galinkin, MD, an anesthesiologist and former member of the FDA advisory committee for analgesics and addiction products, said he is “pleased to see this much-needed, high-dose naloxone product will become part of the treatment tool kit as a countermeasure to the continued surge in fentanyl related deaths.”
“The higher intramuscular doses of naloxone in ZIMHI should result in more rapid and higher levels of naloxone in the systemic circulation, which in turn, should result in more successful resuscitations,” Dr. Galinkin said.
Last spring the FDA approved a higher-dose naloxone hydrochloride nasal spray (Kloxxado) for the emergency treatment of opioid overdose.
Kloxxado delivers 8 mg of naloxone into the nasal cavity, which is twice as much as the 4 mg of naloxone contained in Narcan nasal spray.
The FDA approved ZIMHI (and Kloxxado) through the 505(b)(2) regulatory pathway, which allows the agency to refer to previous findings of safety and efficacy for an already-approved product, as well as to review findings from further studies of the product.
The company plans to launch ZIMHI in the first quarter of 2022.
A version of this article first appeared on Medscape.com.
ZIMHI from Adamis Pharmaceuticals is administered using a single-dose, prefilled syringe that delivers 5 mg of naloxone hydrochloride solution through intramuscular or subcutaneous injection.
Naloxone is an opioid antagonist that works by blocking or reversing the effects of the opioid, including extreme drowsiness, slowed breathing, or loss of consciousness.
Opioid-related overdose deaths — driven partly by prescription drug overdoses — remain a leading cause of death in the United States.
ZIMHI “provides an additional option in the treatment of opioid overdoses,” the FDA said in a statement announcing approval.
In a statement from Adamis Pharmaceuticals, Jeffrey Galinkin, MD, an anesthesiologist and former member of the FDA advisory committee for analgesics and addiction products, said he is “pleased to see this much-needed, high-dose naloxone product will become part of the treatment tool kit as a countermeasure to the continued surge in fentanyl related deaths.”
“The higher intramuscular doses of naloxone in ZIMHI should result in more rapid and higher levels of naloxone in the systemic circulation, which in turn, should result in more successful resuscitations,” Dr. Galinkin said.
Last spring the FDA approved a higher-dose naloxone hydrochloride nasal spray (Kloxxado) for the emergency treatment of opioid overdose.
Kloxxado delivers 8 mg of naloxone into the nasal cavity, which is twice as much as the 4 mg of naloxone contained in Narcan nasal spray.
The FDA approved ZIMHI (and Kloxxado) through the 505(b)(2) regulatory pathway, which allows the agency to refer to previous findings of safety and efficacy for an already-approved product, as well as to review findings from further studies of the product.
The company plans to launch ZIMHI in the first quarter of 2022.
A version of this article first appeared on Medscape.com.
Use live donors for liver transplants for HCC patients, say experts
A new study shows that outcomes with liver transplants from live donors are better than outcomes with transplants from deceased donors, leading to calls for increasing the availability of live donation.
“Transplant programs worldwide should be encouraged to expand their live donor programs to manage patients with HCC,” suggest authors of the new study, published in September in JAMA Surgery.
The findings are important in light of the fact that among patients with HCC, liver transplants are restricted to those patients who have the highest chances of survival, owing to long donor organ waiting lists, say the authors. Use of transplants from living donors could increase the availability of organs for patients on the deceased donor waiting list.
“One could even argue that a living donor gives two organs back to the organ pool,” the authors comment.
“Efforts to expand the donor pool through living donor liver transplant for patients with HCC will ultimately increase the number of available deceased donor liver transplants to help all patients in need of liver transplant,” David A. Gerber, MD, of the University of North Carolina at Chapel Hill, and colleagues write in an accompanying commentary.
“It is very important that donors aren’t recruited or solicited, but with the growth of transplant programs, more potential donors will become aware of this opportunity and will step forward seeking to help someone else,” Dr. Gerber commented.
Live liver donor = lower death risk
The new study was conducted by first author Quirino Laid, MD, PhD, of the Department of General Surgery and Organ Transplantation, Sapienza University, Rome, and colleagues. They explain that the need to better understand the potential benefits of living donor organs is pressing. Liver cancer rates continue to rise, and the demand for organs outpaces the supply. Although various smaller studies have shown survival benefits of live donor liver transplant for people with HCC, debate continues. Previous evidence has suggested higher cancer recurrence rates and unfavorable outcomes.
The multicenter study is thought to be the largest to date on this issue. The investigators evaluated data from patients who were on liver donation waiting lists for a first transplant between January 2000 and December 2017. The study included two cohorts of patients on waiting lists: an international cohort, consisting of 3,052 patients at 12 collaborative transplant centers in Europe, Asia, and the United States; and a Canadian cohort, consisting of 906 patients.
The majority of patients were men (80.2%). The median age at the time of first referral was 58 years.
About a third of patients (33.1%) in the international cohort and slightly fewer than a third (27%) in the Canadian cohort received live donor liver transplants; the reminder received liver transplants from deceased donors.
The median follow-up period was 3.3 years. Receiving a live donor liver transplant was independently associated with a 49% reduction in the overall risk for death (hazard ratio, 0.51) in the international cohort and a 43% reduction in the Canadian cohort (HR, 0.57; both P < .001).
After adjustment for potential confounders, living donor liver transplantation remained independently associated with a reduced the risk for overall death. There was a reduction of 33% in the international cohort (P = .001) and a reduction of 48% in the Canadian cohort (P < .001).
“Divergent experiences all converged to a similar 40% to 50% reduction in intention-to-treat death risk,” the authors write.
Importantly, there were no increases in post-transplant cancer recurrence rates in the live donor groups in either cohort. Rates ranged from 13% to 16% over 5 years and from 17% to 22% after 10 years in both groups.
The median amount of time on the waiting list was significantly shorter for patients in the live donor group than for those in the deceased donor group (1 month vs. 6 months in the international cohort [P < .001]; 5 months vs. 6 months in the Canadian cohort [P = .006]).
Notably, in the deceased donor groups, there were 295 dropouts, compared with no dropouts among the live donor patients in the international cohort (P < .001). In the Canadian cohort, the corresponding rates were 32.2% and 13.9% (P < .001).
Diverse transplant centers, larger cohorts set study apart
Although these latest results are consistent with those of recent studies conducted in France, Hong Kong, and elsewhere, in the current study, the cohorts were larger, say the authors.
“Compared with previous studies, all of which were based on relatively small case series, the present study examined the data of almost 4,000 patients who were on a waiting list for a transplant; therefore, this study may be the largest cohort study on this topic,” they point out.
In addition to improved timing of a transplant, other factors, such as patient selection, help explain the better survival, editorialist Dr. Gerber commented.
“Survival improvement [with live donor liver transplants] is a combination of [surgeon] experience in this transplant procedure and an appropriate selection bias, meaning taking patients who aren’t too sick while waiting on the transplant but who would benefit from the operation,” he said.
Gaining that experience may be particularly challenging in the United States, owing to regulatory barriers to expanding the programs, but efforts to overcome that are moving ahead, Dr. Gerber added.
“This issue of where an individual gains the experience or expertise is being discussed as transplantation has grown worldwide,” he notes.
As programs expand, the availability of live liver donors should improve, he suggested.
In a related story, this news organization recently reported on the controversial issue of liver transplant as an option for the treatment of liver metastases resulting from colorectal cancer.
Study coauthor Gonzalo Sapisochin, MD, has received grants from Bayer and Roche outside the submitted work as well as personal fees from Integra, Novartis, and AstraZeneca. No other relevant financial relationships were reported.
A version of this article first appeared on Medscape.com.
A new study shows that outcomes with liver transplants from live donors are better than outcomes with transplants from deceased donors, leading to calls for increasing the availability of live donation.
“Transplant programs worldwide should be encouraged to expand their live donor programs to manage patients with HCC,” suggest authors of the new study, published in September in JAMA Surgery.
The findings are important in light of the fact that among patients with HCC, liver transplants are restricted to those patients who have the highest chances of survival, owing to long donor organ waiting lists, say the authors. Use of transplants from living donors could increase the availability of organs for patients on the deceased donor waiting list.
“One could even argue that a living donor gives two organs back to the organ pool,” the authors comment.
“Efforts to expand the donor pool through living donor liver transplant for patients with HCC will ultimately increase the number of available deceased donor liver transplants to help all patients in need of liver transplant,” David A. Gerber, MD, of the University of North Carolina at Chapel Hill, and colleagues write in an accompanying commentary.
“It is very important that donors aren’t recruited or solicited, but with the growth of transplant programs, more potential donors will become aware of this opportunity and will step forward seeking to help someone else,” Dr. Gerber commented.
Live liver donor = lower death risk
The new study was conducted by first author Quirino Laid, MD, PhD, of the Department of General Surgery and Organ Transplantation, Sapienza University, Rome, and colleagues. They explain that the need to better understand the potential benefits of living donor organs is pressing. Liver cancer rates continue to rise, and the demand for organs outpaces the supply. Although various smaller studies have shown survival benefits of live donor liver transplant for people with HCC, debate continues. Previous evidence has suggested higher cancer recurrence rates and unfavorable outcomes.
The multicenter study is thought to be the largest to date on this issue. The investigators evaluated data from patients who were on liver donation waiting lists for a first transplant between January 2000 and December 2017. The study included two cohorts of patients on waiting lists: an international cohort, consisting of 3,052 patients at 12 collaborative transplant centers in Europe, Asia, and the United States; and a Canadian cohort, consisting of 906 patients.
The majority of patients were men (80.2%). The median age at the time of first referral was 58 years.
About a third of patients (33.1%) in the international cohort and slightly fewer than a third (27%) in the Canadian cohort received live donor liver transplants; the reminder received liver transplants from deceased donors.
The median follow-up period was 3.3 years. Receiving a live donor liver transplant was independently associated with a 49% reduction in the overall risk for death (hazard ratio, 0.51) in the international cohort and a 43% reduction in the Canadian cohort (HR, 0.57; both P < .001).
After adjustment for potential confounders, living donor liver transplantation remained independently associated with a reduced the risk for overall death. There was a reduction of 33% in the international cohort (P = .001) and a reduction of 48% in the Canadian cohort (P < .001).
“Divergent experiences all converged to a similar 40% to 50% reduction in intention-to-treat death risk,” the authors write.
Importantly, there were no increases in post-transplant cancer recurrence rates in the live donor groups in either cohort. Rates ranged from 13% to 16% over 5 years and from 17% to 22% after 10 years in both groups.
The median amount of time on the waiting list was significantly shorter for patients in the live donor group than for those in the deceased donor group (1 month vs. 6 months in the international cohort [P < .001]; 5 months vs. 6 months in the Canadian cohort [P = .006]).
Notably, in the deceased donor groups, there were 295 dropouts, compared with no dropouts among the live donor patients in the international cohort (P < .001). In the Canadian cohort, the corresponding rates were 32.2% and 13.9% (P < .001).
Diverse transplant centers, larger cohorts set study apart
Although these latest results are consistent with those of recent studies conducted in France, Hong Kong, and elsewhere, in the current study, the cohorts were larger, say the authors.
“Compared with previous studies, all of which were based on relatively small case series, the present study examined the data of almost 4,000 patients who were on a waiting list for a transplant; therefore, this study may be the largest cohort study on this topic,” they point out.
In addition to improved timing of a transplant, other factors, such as patient selection, help explain the better survival, editorialist Dr. Gerber commented.
“Survival improvement [with live donor liver transplants] is a combination of [surgeon] experience in this transplant procedure and an appropriate selection bias, meaning taking patients who aren’t too sick while waiting on the transplant but who would benefit from the operation,” he said.
Gaining that experience may be particularly challenging in the United States, owing to regulatory barriers to expanding the programs, but efforts to overcome that are moving ahead, Dr. Gerber added.
“This issue of where an individual gains the experience or expertise is being discussed as transplantation has grown worldwide,” he notes.
As programs expand, the availability of live liver donors should improve, he suggested.
In a related story, this news organization recently reported on the controversial issue of liver transplant as an option for the treatment of liver metastases resulting from colorectal cancer.
Study coauthor Gonzalo Sapisochin, MD, has received grants from Bayer and Roche outside the submitted work as well as personal fees from Integra, Novartis, and AstraZeneca. No other relevant financial relationships were reported.
A version of this article first appeared on Medscape.com.
A new study shows that outcomes with liver transplants from live donors are better than outcomes with transplants from deceased donors, leading to calls for increasing the availability of live donation.
“Transplant programs worldwide should be encouraged to expand their live donor programs to manage patients with HCC,” suggest authors of the new study, published in September in JAMA Surgery.
The findings are important in light of the fact that among patients with HCC, liver transplants are restricted to those patients who have the highest chances of survival, owing to long donor organ waiting lists, say the authors. Use of transplants from living donors could increase the availability of organs for patients on the deceased donor waiting list.
“One could even argue that a living donor gives two organs back to the organ pool,” the authors comment.
“Efforts to expand the donor pool through living donor liver transplant for patients with HCC will ultimately increase the number of available deceased donor liver transplants to help all patients in need of liver transplant,” David A. Gerber, MD, of the University of North Carolina at Chapel Hill, and colleagues write in an accompanying commentary.
“It is very important that donors aren’t recruited or solicited, but with the growth of transplant programs, more potential donors will become aware of this opportunity and will step forward seeking to help someone else,” Dr. Gerber commented.
Live liver donor = lower death risk
The new study was conducted by first author Quirino Laid, MD, PhD, of the Department of General Surgery and Organ Transplantation, Sapienza University, Rome, and colleagues. They explain that the need to better understand the potential benefits of living donor organs is pressing. Liver cancer rates continue to rise, and the demand for organs outpaces the supply. Although various smaller studies have shown survival benefits of live donor liver transplant for people with HCC, debate continues. Previous evidence has suggested higher cancer recurrence rates and unfavorable outcomes.
The multicenter study is thought to be the largest to date on this issue. The investigators evaluated data from patients who were on liver donation waiting lists for a first transplant between January 2000 and December 2017. The study included two cohorts of patients on waiting lists: an international cohort, consisting of 3,052 patients at 12 collaborative transplant centers in Europe, Asia, and the United States; and a Canadian cohort, consisting of 906 patients.
The majority of patients were men (80.2%). The median age at the time of first referral was 58 years.
About a third of patients (33.1%) in the international cohort and slightly fewer than a third (27%) in the Canadian cohort received live donor liver transplants; the reminder received liver transplants from deceased donors.
The median follow-up period was 3.3 years. Receiving a live donor liver transplant was independently associated with a 49% reduction in the overall risk for death (hazard ratio, 0.51) in the international cohort and a 43% reduction in the Canadian cohort (HR, 0.57; both P < .001).
After adjustment for potential confounders, living donor liver transplantation remained independently associated with a reduced the risk for overall death. There was a reduction of 33% in the international cohort (P = .001) and a reduction of 48% in the Canadian cohort (P < .001).
“Divergent experiences all converged to a similar 40% to 50% reduction in intention-to-treat death risk,” the authors write.
Importantly, there were no increases in post-transplant cancer recurrence rates in the live donor groups in either cohort. Rates ranged from 13% to 16% over 5 years and from 17% to 22% after 10 years in both groups.
The median amount of time on the waiting list was significantly shorter for patients in the live donor group than for those in the deceased donor group (1 month vs. 6 months in the international cohort [P < .001]; 5 months vs. 6 months in the Canadian cohort [P = .006]).
Notably, in the deceased donor groups, there were 295 dropouts, compared with no dropouts among the live donor patients in the international cohort (P < .001). In the Canadian cohort, the corresponding rates were 32.2% and 13.9% (P < .001).
Diverse transplant centers, larger cohorts set study apart
Although these latest results are consistent with those of recent studies conducted in France, Hong Kong, and elsewhere, in the current study, the cohorts were larger, say the authors.
“Compared with previous studies, all of which were based on relatively small case series, the present study examined the data of almost 4,000 patients who were on a waiting list for a transplant; therefore, this study may be the largest cohort study on this topic,” they point out.
In addition to improved timing of a transplant, other factors, such as patient selection, help explain the better survival, editorialist Dr. Gerber commented.
“Survival improvement [with live donor liver transplants] is a combination of [surgeon] experience in this transplant procedure and an appropriate selection bias, meaning taking patients who aren’t too sick while waiting on the transplant but who would benefit from the operation,” he said.
Gaining that experience may be particularly challenging in the United States, owing to regulatory barriers to expanding the programs, but efforts to overcome that are moving ahead, Dr. Gerber added.
“This issue of where an individual gains the experience or expertise is being discussed as transplantation has grown worldwide,” he notes.
As programs expand, the availability of live liver donors should improve, he suggested.
In a related story, this news organization recently reported on the controversial issue of liver transplant as an option for the treatment of liver metastases resulting from colorectal cancer.
Study coauthor Gonzalo Sapisochin, MD, has received grants from Bayer and Roche outside the submitted work as well as personal fees from Integra, Novartis, and AstraZeneca. No other relevant financial relationships were reported.
A version of this article first appeared on Medscape.com.
AGA News
New patient care resource: NASH Clinical Care Pathway
The American Gastroenterological Association – in collaboration with seven professional associations – assembled a multidisciplinary taskforce of 15 experts to develop an action plan to develop a nonalcoholic fatty liver disease (NAFLD)/nonalcoholic steatohepatitis (NASH) Clinical Care Pathway providing practical guidance across multiple disciplines of care. The guidance ranges from screening and diagnosis to management of individuals with NAFLD and NASH, as well as facilitating value-based, efficient, and safe care that is consistent with evidence-based guidelines.
This clinical care pathway is intended to be applicable in any setting in which care for patients with NAFLD is provided, including primary care, endocrine, obesity medicine, and gastroenterology practices.
Read the special report: Clinical Care Pathway for the Risk Stratification and Management of Patients with Nonalcoholic Fatty Liver Disease.
To learn more about the development of this publication, visit NASH.gastro.org.
GI societies push CMS for payment rules favorable for practices
As part of our longstanding collaboration and ongoing efforts on critical policy and payment issues impacting GI clinicians, AGA, the American College of Gastroenterology, and American Society for Gastrointestinal Endoscopy submitted comments on proposed 2022 Medicare payments to physicians, ambulatory surgery centers (ASCs), and hospital outpatient departments to the CMS. We advocated for the following:
Increased and more accurate valuation for peroral endoscopic myotomy (POEM) and capsule endoscopy services.
Continued flexibility and payment parity for telehealth and telephone services.
Elimination of the secondary scalar for ASCs, which contributes to the widening differential in payments to ASCs compared to the hospital outpatient department.
You can access our letter here.
New patient care resource: NASH Clinical Care Pathway
The American Gastroenterological Association – in collaboration with seven professional associations – assembled a multidisciplinary taskforce of 15 experts to develop an action plan to develop a nonalcoholic fatty liver disease (NAFLD)/nonalcoholic steatohepatitis (NASH) Clinical Care Pathway providing practical guidance across multiple disciplines of care. The guidance ranges from screening and diagnosis to management of individuals with NAFLD and NASH, as well as facilitating value-based, efficient, and safe care that is consistent with evidence-based guidelines.
This clinical care pathway is intended to be applicable in any setting in which care for patients with NAFLD is provided, including primary care, endocrine, obesity medicine, and gastroenterology practices.
Read the special report: Clinical Care Pathway for the Risk Stratification and Management of Patients with Nonalcoholic Fatty Liver Disease.
To learn more about the development of this publication, visit NASH.gastro.org.
GI societies push CMS for payment rules favorable for practices
As part of our longstanding collaboration and ongoing efforts on critical policy and payment issues impacting GI clinicians, AGA, the American College of Gastroenterology, and American Society for Gastrointestinal Endoscopy submitted comments on proposed 2022 Medicare payments to physicians, ambulatory surgery centers (ASCs), and hospital outpatient departments to the CMS. We advocated for the following:
Increased and more accurate valuation for peroral endoscopic myotomy (POEM) and capsule endoscopy services.
Continued flexibility and payment parity for telehealth and telephone services.
Elimination of the secondary scalar for ASCs, which contributes to the widening differential in payments to ASCs compared to the hospital outpatient department.
You can access our letter here.
New patient care resource: NASH Clinical Care Pathway
The American Gastroenterological Association – in collaboration with seven professional associations – assembled a multidisciplinary taskforce of 15 experts to develop an action plan to develop a nonalcoholic fatty liver disease (NAFLD)/nonalcoholic steatohepatitis (NASH) Clinical Care Pathway providing practical guidance across multiple disciplines of care. The guidance ranges from screening and diagnosis to management of individuals with NAFLD and NASH, as well as facilitating value-based, efficient, and safe care that is consistent with evidence-based guidelines.
This clinical care pathway is intended to be applicable in any setting in which care for patients with NAFLD is provided, including primary care, endocrine, obesity medicine, and gastroenterology practices.
Read the special report: Clinical Care Pathway for the Risk Stratification and Management of Patients with Nonalcoholic Fatty Liver Disease.
To learn more about the development of this publication, visit NASH.gastro.org.
GI societies push CMS for payment rules favorable for practices
As part of our longstanding collaboration and ongoing efforts on critical policy and payment issues impacting GI clinicians, AGA, the American College of Gastroenterology, and American Society for Gastrointestinal Endoscopy submitted comments on proposed 2022 Medicare payments to physicians, ambulatory surgery centers (ASCs), and hospital outpatient departments to the CMS. We advocated for the following:
Increased and more accurate valuation for peroral endoscopic myotomy (POEM) and capsule endoscopy services.
Continued flexibility and payment parity for telehealth and telephone services.
Elimination of the secondary scalar for ASCs, which contributes to the widening differential in payments to ASCs compared to the hospital outpatient department.
You can access our letter here.
November 2021 – ICYMI
Gastroenterology
August 2021
How to perform a high-quality endoscopic submucosal dissection
Saito Y et al. Gastroenterology. 2021 Aug;161(2):405-10. doi: 10.1053/j.gastro.2021.05.051.
Comparative effectiveness of multiple different first-line treatment regimens for Helicobacter pylori infection: A network meta-analysis
Rokkas T et al. Gastroenterology. 2021 Aug;161(2):495-507.e4. doi: 10.1053/j.gastro.2021.04.012.
The optimal age to stop endoscopic surveillance of patients with Barrett’s esophagus based on sex and comorbidity: A comparative cost-effectiveness analysis
Omidvari AH et al. Gastroenterology. 2021 Aug;161(2):487-94.e4. doi: 10.1053/j.gastro.2021.05.003.
Development and validation of test for “leaky gut” small intestinal and colonic permeability using sugars in healthy adults
Khoshbin K et al. Gastroenterology. 2021 Aug;161(2):463-75.e13. doi: 10.1053/j.gastro.2021.04.020.
September 2021
Pregnancy and the working gastroenterologist: Perceptions, realities, and systemic challenges
David YN et al. Gastroenterology. 2021 Sep;161(3):756-60. doi: 10.1053/j.gastro.2021.05.053.
New drugs on the horizon for functional and motility gastrointestinal disorders
Camilleri M. Gastroenterology. 2021 Sep;161(3):761-4. doi: 10.1053/j.gastro.2021.04.079.
A randomized trial comparing the specific carbohydrate diet to a Mediterranean diet in adults with Crohn’s disease
Lewis JD et al. Gastroenterology. 2021 Sep;161(3):837-52.e9. doi: 10.1053/j.gastro.2021.05.047.
How to promote career advancement and gender equity for women in gastroenterology: a multifaceted approach
Chua SG et al. Gastroenterology. 2021 Sep;161(3):792-7. doi: 10.1053/j.gastro.2021.06.057.
October 2021
How to approach a patient with difficult-to-treat IBS
Chang L. Gastroenterology. 2021 Oct;161(4):1092-8.e3. doi: 10.1053/j.gastro.2021.07.034.
Early-age onset colorectal neoplasia in average-risk individuals undergoing screening colonoscopy: A systematic review and meta-analysis
Kolb JM et al. Gastroenterology. 2021 Oct;161(4):1145-55.e12. doi: 10.1053/j.gastro.2021.06.006.
Adalimumab subcutaneous in participants with ulcerative colitis (VARSITY)
Peyrin-Biroulet L et al. Gastroenterology. 2021 Oct;161(4):1156-67.e3. doi: 10.1053/j.gastro.2021.06.015.
Extraintestinal manifestations of inflammatory bowel disease: Current concepts, treatment, and implications for disease management
Rogler G et al. Gastroenterology. 2021 Oct;161(4):1118-32. doi: 10.1053/j.gastro.2021.07.042.
Clinical Gastroenterology and Hepatology
August 2021
Health equity and telemedicine in gastroenterology and hepatology
Wegermann K et al. Clin Gastroenterol Hepatol. 2021 Aug;19(8):1516-9. doi: 10.1016/j.cgh.2021.04.024.
AGA Clinical Practice Update on evaluation and management of early complications after bariatric/metabolic surgery: Expert review
Kumbhari V et al. Clin Gastroenterol Hepatol. 2021 Aug;19(8):1531-7. doi: 10.1016/j.cgh.2021.03.020.
Clinical, pathology, genetic, and molecular features of colorectal tumors in adolescents and adults 25 years or younger
de Voer RM et al. Clin Gastroenterol Hepatol. 2021 Aug;19(8):1642-51.e8. doi: 10.1016/j.cgh.2020.06.034.
Safety of tofacitinib in a real-world cohort of patients with ulcerative colitis
Deepak P et al. Clin Gastroenterol Hepatol. 2021 Aug;19(8):1592-601.e3. doi: 10.1016/j.cgh.2020.06.050.
September 2021
Association of adenoma detection rate and adenoma characteristics with colorectal cancer mortality after screening colonoscopy
Waldmann E et al. Clin Gastroenterol Hepatol. 2021 Sep;19(9):1890-8. doi: 10.1016/j.cgh.2021.04.023.
Prevalence and characteristics of abdominal pain in the United States
Lakhoo K et al. Clin Gastroenterol Hepatol. 2021 Sep;19(9):1864-72.e5. doi: 10.1016/j.cgh.2020.06.065.
Model using clinical and endoscopic characteristics identifies patients at risk for eosinophilic esophagitis according to updated diagnostic guidelines
Cotton CC et al. Clin Gastroenterol Hepatol. 2021 Sep;19(9):1824-34.e2. doi: 10.1016/j.cgh.2020.06.068.
October 2021
A high-yield approach to effective endoscopy teaching and assessment
Huang HZ et al. Clin Gastroenterol Hepatol. 2021 Oct;19(10):1999-2001. doi: 10.1016/j.cgh.2021.07.013.
2021 E/M code changes: Forecasted impacts to gastroenterology practices
Francis DL et al. Clin Gastroenterol Hepatol. 2021 Oct;19(10):2002-5. doi: 10.1016/j.cgh.2021.07.008.
You can’t have one without the other: Innovation and ethical dilemmas in gastroenterology and hepatology
Couri T et al. Clin Gastroenterol Hepatol. 2021 Oct;19(10):2015-9. doi: 10.1016/j.cgh.2020.05.024.
Psychiatric disorders in patients with a diagnosis of celiac disease during childhood from 1973 to 2016
Lebwohl B et al. Clin Gastroenterol Hepatol. 2021 Oct;19(10):2093-101.e13. doi: 10.1016/j.cgh.2020.08.018.
Mast cell and eosinophil counts in gastric and duodenal biopsy specimens from patients with and without eosinophilic gastroenteritis
Reed CC et al. Clin Gastroenterol Hepatol. 2021 Oct;19(10):2102-2111. doi: 10.1016/j.cgh.2020.08.013.
Cellular and Molecular Gastroenterology and Hepatology
Sex differences in the exocrine pancreas and associated diseases
Wang M et al. Cell Mol Gastroenterol Hepatol. 2021;12(2):427-41. doi: 10.1016/j.jcmgh.2021.04.005.
Mesenteric neural crest cells are the embryological basis of skip segment Hirschsprung’s disease
Yu Q et al. Cell Mol Gastroenterol Hepatol. 2021;12(1):1-24. doi: 10.1016/j.jcmgh.2020.12.010.
Helicobacter pylori–induced rev-erbα fosters gastric bacteria colonization by impairing host innate and adaptive defense
Mao MY et al. Cell Mol Gastroenterol Hepatol. 2021;12(2):395-425. doi: 10.1016/j.jcmgh.2021.02.013.
Techniques and Innovations in Gastrointestinal Endoscopy
Staying (mentally) healthy: The impact of COVID-19 on personal and professional lives
Alkandari A et al. Tech Innov Gastrointest Endosc. 2021;23(2):199-206. doi: 10.1016/j.tige.2021.01.003.
Establishing new endoscopic programs in the unit pitfalls and tips for success
Siddiqui UD. Tech Innov Gastrointest Endosc. 2021;23(3):263-7. doi: 10.1016/j.tige.2021.03.002.
Chief of endoscopy: Specific challenges to leading the team and running the unit
Michelle A. Anderson MA et al. Tech Innov Gastrointest Endosc. 2021;23(3):249-55. doi: 10.1016/j.tige.2021.03.004.
Safety in endoscopy for patients and healthcare workers During the COVID-19 pandemic
Lui RN. Tech Innov Gastrointest Endosc. 2021;23(2):170-178. doi: 10.1016/j.tige.2020.10.004.
Gastroenterology
August 2021
How to perform a high-quality endoscopic submucosal dissection
Saito Y et al. Gastroenterology. 2021 Aug;161(2):405-10. doi: 10.1053/j.gastro.2021.05.051.
Comparative effectiveness of multiple different first-line treatment regimens for Helicobacter pylori infection: A network meta-analysis
Rokkas T et al. Gastroenterology. 2021 Aug;161(2):495-507.e4. doi: 10.1053/j.gastro.2021.04.012.
The optimal age to stop endoscopic surveillance of patients with Barrett’s esophagus based on sex and comorbidity: A comparative cost-effectiveness analysis
Omidvari AH et al. Gastroenterology. 2021 Aug;161(2):487-94.e4. doi: 10.1053/j.gastro.2021.05.003.
Development and validation of test for “leaky gut” small intestinal and colonic permeability using sugars in healthy adults
Khoshbin K et al. Gastroenterology. 2021 Aug;161(2):463-75.e13. doi: 10.1053/j.gastro.2021.04.020.
September 2021
Pregnancy and the working gastroenterologist: Perceptions, realities, and systemic challenges
David YN et al. Gastroenterology. 2021 Sep;161(3):756-60. doi: 10.1053/j.gastro.2021.05.053.
New drugs on the horizon for functional and motility gastrointestinal disorders
Camilleri M. Gastroenterology. 2021 Sep;161(3):761-4. doi: 10.1053/j.gastro.2021.04.079.
A randomized trial comparing the specific carbohydrate diet to a Mediterranean diet in adults with Crohn’s disease
Lewis JD et al. Gastroenterology. 2021 Sep;161(3):837-52.e9. doi: 10.1053/j.gastro.2021.05.047.
How to promote career advancement and gender equity for women in gastroenterology: a multifaceted approach
Chua SG et al. Gastroenterology. 2021 Sep;161(3):792-7. doi: 10.1053/j.gastro.2021.06.057.
October 2021
How to approach a patient with difficult-to-treat IBS
Chang L. Gastroenterology. 2021 Oct;161(4):1092-8.e3. doi: 10.1053/j.gastro.2021.07.034.
Early-age onset colorectal neoplasia in average-risk individuals undergoing screening colonoscopy: A systematic review and meta-analysis
Kolb JM et al. Gastroenterology. 2021 Oct;161(4):1145-55.e12. doi: 10.1053/j.gastro.2021.06.006.
Adalimumab subcutaneous in participants with ulcerative colitis (VARSITY)
Peyrin-Biroulet L et al. Gastroenterology. 2021 Oct;161(4):1156-67.e3. doi: 10.1053/j.gastro.2021.06.015.
Extraintestinal manifestations of inflammatory bowel disease: Current concepts, treatment, and implications for disease management
Rogler G et al. Gastroenterology. 2021 Oct;161(4):1118-32. doi: 10.1053/j.gastro.2021.07.042.
Clinical Gastroenterology and Hepatology
August 2021
Health equity and telemedicine in gastroenterology and hepatology
Wegermann K et al. Clin Gastroenterol Hepatol. 2021 Aug;19(8):1516-9. doi: 10.1016/j.cgh.2021.04.024.
AGA Clinical Practice Update on evaluation and management of early complications after bariatric/metabolic surgery: Expert review
Kumbhari V et al. Clin Gastroenterol Hepatol. 2021 Aug;19(8):1531-7. doi: 10.1016/j.cgh.2021.03.020.
Clinical, pathology, genetic, and molecular features of colorectal tumors in adolescents and adults 25 years or younger
de Voer RM et al. Clin Gastroenterol Hepatol. 2021 Aug;19(8):1642-51.e8. doi: 10.1016/j.cgh.2020.06.034.
Safety of tofacitinib in a real-world cohort of patients with ulcerative colitis
Deepak P et al. Clin Gastroenterol Hepatol. 2021 Aug;19(8):1592-601.e3. doi: 10.1016/j.cgh.2020.06.050.
September 2021
Association of adenoma detection rate and adenoma characteristics with colorectal cancer mortality after screening colonoscopy
Waldmann E et al. Clin Gastroenterol Hepatol. 2021 Sep;19(9):1890-8. doi: 10.1016/j.cgh.2021.04.023.
Prevalence and characteristics of abdominal pain in the United States
Lakhoo K et al. Clin Gastroenterol Hepatol. 2021 Sep;19(9):1864-72.e5. doi: 10.1016/j.cgh.2020.06.065.
Model using clinical and endoscopic characteristics identifies patients at risk for eosinophilic esophagitis according to updated diagnostic guidelines
Cotton CC et al. Clin Gastroenterol Hepatol. 2021 Sep;19(9):1824-34.e2. doi: 10.1016/j.cgh.2020.06.068.
October 2021
A high-yield approach to effective endoscopy teaching and assessment
Huang HZ et al. Clin Gastroenterol Hepatol. 2021 Oct;19(10):1999-2001. doi: 10.1016/j.cgh.2021.07.013.
2021 E/M code changes: Forecasted impacts to gastroenterology practices
Francis DL et al. Clin Gastroenterol Hepatol. 2021 Oct;19(10):2002-5. doi: 10.1016/j.cgh.2021.07.008.
You can’t have one without the other: Innovation and ethical dilemmas in gastroenterology and hepatology
Couri T et al. Clin Gastroenterol Hepatol. 2021 Oct;19(10):2015-9. doi: 10.1016/j.cgh.2020.05.024.
Psychiatric disorders in patients with a diagnosis of celiac disease during childhood from 1973 to 2016
Lebwohl B et al. Clin Gastroenterol Hepatol. 2021 Oct;19(10):2093-101.e13. doi: 10.1016/j.cgh.2020.08.018.
Mast cell and eosinophil counts in gastric and duodenal biopsy specimens from patients with and without eosinophilic gastroenteritis
Reed CC et al. Clin Gastroenterol Hepatol. 2021 Oct;19(10):2102-2111. doi: 10.1016/j.cgh.2020.08.013.
Cellular and Molecular Gastroenterology and Hepatology
Sex differences in the exocrine pancreas and associated diseases
Wang M et al. Cell Mol Gastroenterol Hepatol. 2021;12(2):427-41. doi: 10.1016/j.jcmgh.2021.04.005.
Mesenteric neural crest cells are the embryological basis of skip segment Hirschsprung’s disease
Yu Q et al. Cell Mol Gastroenterol Hepatol. 2021;12(1):1-24. doi: 10.1016/j.jcmgh.2020.12.010.
Helicobacter pylori–induced rev-erbα fosters gastric bacteria colonization by impairing host innate and adaptive defense
Mao MY et al. Cell Mol Gastroenterol Hepatol. 2021;12(2):395-425. doi: 10.1016/j.jcmgh.2021.02.013.
Techniques and Innovations in Gastrointestinal Endoscopy
Staying (mentally) healthy: The impact of COVID-19 on personal and professional lives
Alkandari A et al. Tech Innov Gastrointest Endosc. 2021;23(2):199-206. doi: 10.1016/j.tige.2021.01.003.
Establishing new endoscopic programs in the unit pitfalls and tips for success
Siddiqui UD. Tech Innov Gastrointest Endosc. 2021;23(3):263-7. doi: 10.1016/j.tige.2021.03.002.
Chief of endoscopy: Specific challenges to leading the team and running the unit
Michelle A. Anderson MA et al. Tech Innov Gastrointest Endosc. 2021;23(3):249-55. doi: 10.1016/j.tige.2021.03.004.
Safety in endoscopy for patients and healthcare workers During the COVID-19 pandemic
Lui RN. Tech Innov Gastrointest Endosc. 2021;23(2):170-178. doi: 10.1016/j.tige.2020.10.004.
Gastroenterology
August 2021
How to perform a high-quality endoscopic submucosal dissection
Saito Y et al. Gastroenterology. 2021 Aug;161(2):405-10. doi: 10.1053/j.gastro.2021.05.051.
Comparative effectiveness of multiple different first-line treatment regimens for Helicobacter pylori infection: A network meta-analysis
Rokkas T et al. Gastroenterology. 2021 Aug;161(2):495-507.e4. doi: 10.1053/j.gastro.2021.04.012.
The optimal age to stop endoscopic surveillance of patients with Barrett’s esophagus based on sex and comorbidity: A comparative cost-effectiveness analysis
Omidvari AH et al. Gastroenterology. 2021 Aug;161(2):487-94.e4. doi: 10.1053/j.gastro.2021.05.003.
Development and validation of test for “leaky gut” small intestinal and colonic permeability using sugars in healthy adults
Khoshbin K et al. Gastroenterology. 2021 Aug;161(2):463-75.e13. doi: 10.1053/j.gastro.2021.04.020.
September 2021
Pregnancy and the working gastroenterologist: Perceptions, realities, and systemic challenges
David YN et al. Gastroenterology. 2021 Sep;161(3):756-60. doi: 10.1053/j.gastro.2021.05.053.
New drugs on the horizon for functional and motility gastrointestinal disorders
Camilleri M. Gastroenterology. 2021 Sep;161(3):761-4. doi: 10.1053/j.gastro.2021.04.079.
A randomized trial comparing the specific carbohydrate diet to a Mediterranean diet in adults with Crohn’s disease
Lewis JD et al. Gastroenterology. 2021 Sep;161(3):837-52.e9. doi: 10.1053/j.gastro.2021.05.047.
How to promote career advancement and gender equity for women in gastroenterology: a multifaceted approach
Chua SG et al. Gastroenterology. 2021 Sep;161(3):792-7. doi: 10.1053/j.gastro.2021.06.057.
October 2021
How to approach a patient with difficult-to-treat IBS
Chang L. Gastroenterology. 2021 Oct;161(4):1092-8.e3. doi: 10.1053/j.gastro.2021.07.034.
Early-age onset colorectal neoplasia in average-risk individuals undergoing screening colonoscopy: A systematic review and meta-analysis
Kolb JM et al. Gastroenterology. 2021 Oct;161(4):1145-55.e12. doi: 10.1053/j.gastro.2021.06.006.
Adalimumab subcutaneous in participants with ulcerative colitis (VARSITY)
Peyrin-Biroulet L et al. Gastroenterology. 2021 Oct;161(4):1156-67.e3. doi: 10.1053/j.gastro.2021.06.015.
Extraintestinal manifestations of inflammatory bowel disease: Current concepts, treatment, and implications for disease management
Rogler G et al. Gastroenterology. 2021 Oct;161(4):1118-32. doi: 10.1053/j.gastro.2021.07.042.
Clinical Gastroenterology and Hepatology
August 2021
Health equity and telemedicine in gastroenterology and hepatology
Wegermann K et al. Clin Gastroenterol Hepatol. 2021 Aug;19(8):1516-9. doi: 10.1016/j.cgh.2021.04.024.
AGA Clinical Practice Update on evaluation and management of early complications after bariatric/metabolic surgery: Expert review
Kumbhari V et al. Clin Gastroenterol Hepatol. 2021 Aug;19(8):1531-7. doi: 10.1016/j.cgh.2021.03.020.
Clinical, pathology, genetic, and molecular features of colorectal tumors in adolescents and adults 25 years or younger
de Voer RM et al. Clin Gastroenterol Hepatol. 2021 Aug;19(8):1642-51.e8. doi: 10.1016/j.cgh.2020.06.034.
Safety of tofacitinib in a real-world cohort of patients with ulcerative colitis
Deepak P et al. Clin Gastroenterol Hepatol. 2021 Aug;19(8):1592-601.e3. doi: 10.1016/j.cgh.2020.06.050.
September 2021
Association of adenoma detection rate and adenoma characteristics with colorectal cancer mortality after screening colonoscopy
Waldmann E et al. Clin Gastroenterol Hepatol. 2021 Sep;19(9):1890-8. doi: 10.1016/j.cgh.2021.04.023.
Prevalence and characteristics of abdominal pain in the United States
Lakhoo K et al. Clin Gastroenterol Hepatol. 2021 Sep;19(9):1864-72.e5. doi: 10.1016/j.cgh.2020.06.065.
Model using clinical and endoscopic characteristics identifies patients at risk for eosinophilic esophagitis according to updated diagnostic guidelines
Cotton CC et al. Clin Gastroenterol Hepatol. 2021 Sep;19(9):1824-34.e2. doi: 10.1016/j.cgh.2020.06.068.
October 2021
A high-yield approach to effective endoscopy teaching and assessment
Huang HZ et al. Clin Gastroenterol Hepatol. 2021 Oct;19(10):1999-2001. doi: 10.1016/j.cgh.2021.07.013.
2021 E/M code changes: Forecasted impacts to gastroenterology practices
Francis DL et al. Clin Gastroenterol Hepatol. 2021 Oct;19(10):2002-5. doi: 10.1016/j.cgh.2021.07.008.
You can’t have one without the other: Innovation and ethical dilemmas in gastroenterology and hepatology
Couri T et al. Clin Gastroenterol Hepatol. 2021 Oct;19(10):2015-9. doi: 10.1016/j.cgh.2020.05.024.
Psychiatric disorders in patients with a diagnosis of celiac disease during childhood from 1973 to 2016
Lebwohl B et al. Clin Gastroenterol Hepatol. 2021 Oct;19(10):2093-101.e13. doi: 10.1016/j.cgh.2020.08.018.
Mast cell and eosinophil counts in gastric and duodenal biopsy specimens from patients with and without eosinophilic gastroenteritis
Reed CC et al. Clin Gastroenterol Hepatol. 2021 Oct;19(10):2102-2111. doi: 10.1016/j.cgh.2020.08.013.
Cellular and Molecular Gastroenterology and Hepatology
Sex differences in the exocrine pancreas and associated diseases
Wang M et al. Cell Mol Gastroenterol Hepatol. 2021;12(2):427-41. doi: 10.1016/j.jcmgh.2021.04.005.
Mesenteric neural crest cells are the embryological basis of skip segment Hirschsprung’s disease
Yu Q et al. Cell Mol Gastroenterol Hepatol. 2021;12(1):1-24. doi: 10.1016/j.jcmgh.2020.12.010.
Helicobacter pylori–induced rev-erbα fosters gastric bacteria colonization by impairing host innate and adaptive defense
Mao MY et al. Cell Mol Gastroenterol Hepatol. 2021;12(2):395-425. doi: 10.1016/j.jcmgh.2021.02.013.
Techniques and Innovations in Gastrointestinal Endoscopy
Staying (mentally) healthy: The impact of COVID-19 on personal and professional lives
Alkandari A et al. Tech Innov Gastrointest Endosc. 2021;23(2):199-206. doi: 10.1016/j.tige.2021.01.003.
Establishing new endoscopic programs in the unit pitfalls and tips for success
Siddiqui UD. Tech Innov Gastrointest Endosc. 2021;23(3):263-7. doi: 10.1016/j.tige.2021.03.002.
Chief of endoscopy: Specific challenges to leading the team and running the unit
Michelle A. Anderson MA et al. Tech Innov Gastrointest Endosc. 2021;23(3):249-55. doi: 10.1016/j.tige.2021.03.004.
Safety in endoscopy for patients and healthcare workers During the COVID-19 pandemic
Lui RN. Tech Innov Gastrointest Endosc. 2021;23(2):170-178. doi: 10.1016/j.tige.2020.10.004.
ECTRIMS/EAN statement on COVID-19 vaccination in patients with MS
(MS).
The statement was released at the annual meeting of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). The statement concludes that the COVID-19 vaccines that are currently available are safe for patients with MS. Further, it states that the vaccines confer the same protection for patients with MS as they do for the general population. Exceptions may be patients taking the S1P modulator fingolimod and anti-CD20 drugs. For these patients, antibody responses have been shown to be reduced.
This position statement will be published on the ECTRIMS and EAN websites. Owing to the shifting, ongoing nature of evidence, the position statement will be updated periodically.
Presenting the statement, Mauricio Farez, MD, Fundacion FLENI, Buenos Aires, concluded: “Overall, MS patients do not seem to develop more severe forms of COVID-19 as compared with healthy controls, but patients with greater disability, anti-CD20 treatment, or those with recent steroid use have a higher risk of severe disease.”
“So far there are no specific contraindications for any COVID vaccines in MS patients reported,” he added. “We should work with our patients to keep them safe with vaccines while optimizing treatment strategies and MS management, in particular for those treated with anti-CD20 and S1P modulators.”
Risk for COVID-19 among patients with MS
On the issue of whether patients with MS are at higher risk for COVID-19 or for having a more severe form of the disease, Dr. Farez noted that studies published to date are reassuring and don’t suggest major problems regarding safety.
The main factors that are associated with more serious forms of COVID in patients with MS are similar to those in the general population. These include age, obesity, diabetes, male sex, and Black race.
As for any risk associated with MS therapies, interferons and glatiramer acetate do not increase the risk of getting COVID-19 or worsen the clinical course of the disease. Fingolimod, teriflunomide, natalizumab, and dimethyl fumarate also do not seem to negatively affect risk for COVID-19, according to the statement.
However, several studies have shown that anti-CD20 therapies, such as ocrelizumab, and steroid pulses can confer an increased risk for COVID-19.
COVID-19 vaccine safety
Four COVID-19 vaccines are licensed for use in the European Union. These include two mRNA vaccines – Spikevax (Moderna) and Comimaty (Pfizer) – and two adenovirus-based vaccines, one from Janssen (J&J) and the other from AstraZeneca. Five other COVID-19 vaccines are under review and may be available in the future.
All the currently available vaccines can be administered to patients with MS, including patients receiving immunosuppressant disease-modifying therapies, the statement notes.
In real-life clinical practice, no red flags have been observed for patients with MS who have received mRNA vaccines to date. Nevertheless, because immunocompromised patients and those taking immunomodulators were excluded from trials, continued surveillance for immune-mediated adverse effects is warranted, Dr. Farez said.
Regarding possible effects of vaccines on MS relapses/disability, no significant adverse effects occurred in a study conducted in Israel (by Achiron and colleagues) that involved 435 patients with MS who were fully vaccinated with the Pfizer mRNA vaccine. The relapse rate was 1.6%, similar to the rate among patients who did not have MS. A study by Di Filippo and colleagues showed no significant changes in relapse rate in the 2 months following immunization with the Pfizer vaccine among 324 patients with MS.
“There are no specific contraindications to any of the vaccines particularly for MS patients compared with the general population,” Dr. Farez noted.
Are there different recommendations for different MS therapies?
On the issue of vaccine effects in patients taking various disease-modifying treatments, the statement says that the data on this are limited. Patients taking interferons, glatiramer acetate, teriflunomide, and fumarates whose lymphocyte counts are normal will most likely be adequately protected. Patients with moderate to severe lymphopenia may not mount an adequate immune response to COVID-19 vaccination, so absolute lymphocyte count may be checked before vaccination.
Patients taking natalizumab will also likely be protected with COVID vaccination.
It is likely that for patients taking alemtuzumab, immune cellular and humoral response to COVID-10 vaccines will be attenuated, especially in the first 6 months during maximum lymphopenia. If possible, vaccination should be delayed until at least 6 months after treatment. It is thought that patients who have completed both courses of alemtuzumab with complete immune reconstitution will mount a full immune response.
In studies, all patients with MS who were treated with cladribine demonstrated a protective humoral immune response to the COVID-19 vaccine. In those studies, the antibody response was evident about 4 months after the last treatment dose, and the titer did not differ from that of healthy persons, Dr. Farez reported.
Low antibody level with fingolimod
The majority of patients treated with fingolimod have failed to show a protective level of antibodies following COVID-19 vaccination, the statement notes.
Asked whether patients taking fingolimod should receive a COVID vaccination, Dr. Farez said that that was a good question. “We have to think about what is an immune response. Antibodies are only a small fraction of all immune responses. So, until we have data to show otherwise, I think we should vaccinate – any immunity is better than no immunity,” he said.
Dr. Farez also suggested that patients with MS who are taking fingolimod should continue to do so. “Any treatment for MS is better than none. If fingolimod is stopped, MS may rebound. So, the most likely scenario would be to keep treating with fingolimod and to give the vaccination. But these patients may need a more aggressive booster approach – we will be looking at that,” he said.
Anti-CD20 antibody drugs
Patients taking ocrelizumab also do not mount an appropriate antibody response regardless of lymphocyte count or the time interval from the last ocrelizumab dose (3-9 months), the statement says. To optimize vaccine efficacy and to balance benefits and risks, the statement advises administering COVID vaccines at least 12 weeks after administering ocrelizumab and 4-6 weeks prior to the next dose, whenever possible.
A study by Apostolidis and colleagues provides strong evidence of immune priming by COVID vaccination in patients treated with anti-CD20 medications. Although for most of these patients, antibody responses are not optimal, T-cell priming is largely intact, Dr. Farez noted.
Booster doses/antibody tests
The need for and timing of COVID vaccine booster doses have not been established. “This is being discussed now for the general population. The recommendations for MS patients will not differ significantly from those for the general population, apart from perhaps for specific populations such as those on anti-CD20 drugs or fingolimod,” Dr. Farez said.
Antibody testing is not currently recommended for assessing immunity following COVID vaccination because the clinical utility and serologic correlates of protection after vaccination have not been established. Antibody testing does not evaluate the cellular immune response, which may play a role in vaccine-mediated protection, according to the statement.
Vaccination strategy after COVID
People should be offered vaccination regardless of their history of symptomatic or asymptomatic COVID-19, including people with prolonged post-COVID symptoms. Data from clinical trials indicate that the currently authorized vaccines can be given safely to people with evidence of prior SARS-CoV-2 infection. For people who are known to be currently infected with SARS-CoV-2, vaccination should be deferred until the acute illness has passed.
Pregnancy/children
Data on the safety of COVID vaccines during pregnancy are limited. On the basis of current knowledge, experts believe that it is unlikely that COVID vaccines pose a risk to the pregnant person or fetus, and thus pregnant people with MS are eligible for and can receive a COVID-19 vaccine, the statement notes.
Adolescents aged 12-17 are eligible to receive the authorized mRNA vaccine, but children younger than 12 are not authorized to receive any COVID vaccine at this time, it adds.
A version of this article first appeared on Medscape.com.
(MS).
The statement was released at the annual meeting of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). The statement concludes that the COVID-19 vaccines that are currently available are safe for patients with MS. Further, it states that the vaccines confer the same protection for patients with MS as they do for the general population. Exceptions may be patients taking the S1P modulator fingolimod and anti-CD20 drugs. For these patients, antibody responses have been shown to be reduced.
This position statement will be published on the ECTRIMS and EAN websites. Owing to the shifting, ongoing nature of evidence, the position statement will be updated periodically.
Presenting the statement, Mauricio Farez, MD, Fundacion FLENI, Buenos Aires, concluded: “Overall, MS patients do not seem to develop more severe forms of COVID-19 as compared with healthy controls, but patients with greater disability, anti-CD20 treatment, or those with recent steroid use have a higher risk of severe disease.”
“So far there are no specific contraindications for any COVID vaccines in MS patients reported,” he added. “We should work with our patients to keep them safe with vaccines while optimizing treatment strategies and MS management, in particular for those treated with anti-CD20 and S1P modulators.”
Risk for COVID-19 among patients with MS
On the issue of whether patients with MS are at higher risk for COVID-19 or for having a more severe form of the disease, Dr. Farez noted that studies published to date are reassuring and don’t suggest major problems regarding safety.
The main factors that are associated with more serious forms of COVID in patients with MS are similar to those in the general population. These include age, obesity, diabetes, male sex, and Black race.
As for any risk associated with MS therapies, interferons and glatiramer acetate do not increase the risk of getting COVID-19 or worsen the clinical course of the disease. Fingolimod, teriflunomide, natalizumab, and dimethyl fumarate also do not seem to negatively affect risk for COVID-19, according to the statement.
However, several studies have shown that anti-CD20 therapies, such as ocrelizumab, and steroid pulses can confer an increased risk for COVID-19.
COVID-19 vaccine safety
Four COVID-19 vaccines are licensed for use in the European Union. These include two mRNA vaccines – Spikevax (Moderna) and Comimaty (Pfizer) – and two adenovirus-based vaccines, one from Janssen (J&J) and the other from AstraZeneca. Five other COVID-19 vaccines are under review and may be available in the future.
All the currently available vaccines can be administered to patients with MS, including patients receiving immunosuppressant disease-modifying therapies, the statement notes.
In real-life clinical practice, no red flags have been observed for patients with MS who have received mRNA vaccines to date. Nevertheless, because immunocompromised patients and those taking immunomodulators were excluded from trials, continued surveillance for immune-mediated adverse effects is warranted, Dr. Farez said.
Regarding possible effects of vaccines on MS relapses/disability, no significant adverse effects occurred in a study conducted in Israel (by Achiron and colleagues) that involved 435 patients with MS who were fully vaccinated with the Pfizer mRNA vaccine. The relapse rate was 1.6%, similar to the rate among patients who did not have MS. A study by Di Filippo and colleagues showed no significant changes in relapse rate in the 2 months following immunization with the Pfizer vaccine among 324 patients with MS.
“There are no specific contraindications to any of the vaccines particularly for MS patients compared with the general population,” Dr. Farez noted.
Are there different recommendations for different MS therapies?
On the issue of vaccine effects in patients taking various disease-modifying treatments, the statement says that the data on this are limited. Patients taking interferons, glatiramer acetate, teriflunomide, and fumarates whose lymphocyte counts are normal will most likely be adequately protected. Patients with moderate to severe lymphopenia may not mount an adequate immune response to COVID-19 vaccination, so absolute lymphocyte count may be checked before vaccination.
Patients taking natalizumab will also likely be protected with COVID vaccination.
It is likely that for patients taking alemtuzumab, immune cellular and humoral response to COVID-10 vaccines will be attenuated, especially in the first 6 months during maximum lymphopenia. If possible, vaccination should be delayed until at least 6 months after treatment. It is thought that patients who have completed both courses of alemtuzumab with complete immune reconstitution will mount a full immune response.
In studies, all patients with MS who were treated with cladribine demonstrated a protective humoral immune response to the COVID-19 vaccine. In those studies, the antibody response was evident about 4 months after the last treatment dose, and the titer did not differ from that of healthy persons, Dr. Farez reported.
Low antibody level with fingolimod
The majority of patients treated with fingolimod have failed to show a protective level of antibodies following COVID-19 vaccination, the statement notes.
Asked whether patients taking fingolimod should receive a COVID vaccination, Dr. Farez said that that was a good question. “We have to think about what is an immune response. Antibodies are only a small fraction of all immune responses. So, until we have data to show otherwise, I think we should vaccinate – any immunity is better than no immunity,” he said.
Dr. Farez also suggested that patients with MS who are taking fingolimod should continue to do so. “Any treatment for MS is better than none. If fingolimod is stopped, MS may rebound. So, the most likely scenario would be to keep treating with fingolimod and to give the vaccination. But these patients may need a more aggressive booster approach – we will be looking at that,” he said.
Anti-CD20 antibody drugs
Patients taking ocrelizumab also do not mount an appropriate antibody response regardless of lymphocyte count or the time interval from the last ocrelizumab dose (3-9 months), the statement says. To optimize vaccine efficacy and to balance benefits and risks, the statement advises administering COVID vaccines at least 12 weeks after administering ocrelizumab and 4-6 weeks prior to the next dose, whenever possible.
A study by Apostolidis and colleagues provides strong evidence of immune priming by COVID vaccination in patients treated with anti-CD20 medications. Although for most of these patients, antibody responses are not optimal, T-cell priming is largely intact, Dr. Farez noted.
Booster doses/antibody tests
The need for and timing of COVID vaccine booster doses have not been established. “This is being discussed now for the general population. The recommendations for MS patients will not differ significantly from those for the general population, apart from perhaps for specific populations such as those on anti-CD20 drugs or fingolimod,” Dr. Farez said.
Antibody testing is not currently recommended for assessing immunity following COVID vaccination because the clinical utility and serologic correlates of protection after vaccination have not been established. Antibody testing does not evaluate the cellular immune response, which may play a role in vaccine-mediated protection, according to the statement.
Vaccination strategy after COVID
People should be offered vaccination regardless of their history of symptomatic or asymptomatic COVID-19, including people with prolonged post-COVID symptoms. Data from clinical trials indicate that the currently authorized vaccines can be given safely to people with evidence of prior SARS-CoV-2 infection. For people who are known to be currently infected with SARS-CoV-2, vaccination should be deferred until the acute illness has passed.
Pregnancy/children
Data on the safety of COVID vaccines during pregnancy are limited. On the basis of current knowledge, experts believe that it is unlikely that COVID vaccines pose a risk to the pregnant person or fetus, and thus pregnant people with MS are eligible for and can receive a COVID-19 vaccine, the statement notes.
Adolescents aged 12-17 are eligible to receive the authorized mRNA vaccine, but children younger than 12 are not authorized to receive any COVID vaccine at this time, it adds.
A version of this article first appeared on Medscape.com.
(MS).
The statement was released at the annual meeting of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). The statement concludes that the COVID-19 vaccines that are currently available are safe for patients with MS. Further, it states that the vaccines confer the same protection for patients with MS as they do for the general population. Exceptions may be patients taking the S1P modulator fingolimod and anti-CD20 drugs. For these patients, antibody responses have been shown to be reduced.
This position statement will be published on the ECTRIMS and EAN websites. Owing to the shifting, ongoing nature of evidence, the position statement will be updated periodically.
Presenting the statement, Mauricio Farez, MD, Fundacion FLENI, Buenos Aires, concluded: “Overall, MS patients do not seem to develop more severe forms of COVID-19 as compared with healthy controls, but patients with greater disability, anti-CD20 treatment, or those with recent steroid use have a higher risk of severe disease.”
“So far there are no specific contraindications for any COVID vaccines in MS patients reported,” he added. “We should work with our patients to keep them safe with vaccines while optimizing treatment strategies and MS management, in particular for those treated with anti-CD20 and S1P modulators.”
Risk for COVID-19 among patients with MS
On the issue of whether patients with MS are at higher risk for COVID-19 or for having a more severe form of the disease, Dr. Farez noted that studies published to date are reassuring and don’t suggest major problems regarding safety.
The main factors that are associated with more serious forms of COVID in patients with MS are similar to those in the general population. These include age, obesity, diabetes, male sex, and Black race.
As for any risk associated with MS therapies, interferons and glatiramer acetate do not increase the risk of getting COVID-19 or worsen the clinical course of the disease. Fingolimod, teriflunomide, natalizumab, and dimethyl fumarate also do not seem to negatively affect risk for COVID-19, according to the statement.
However, several studies have shown that anti-CD20 therapies, such as ocrelizumab, and steroid pulses can confer an increased risk for COVID-19.
COVID-19 vaccine safety
Four COVID-19 vaccines are licensed for use in the European Union. These include two mRNA vaccines – Spikevax (Moderna) and Comimaty (Pfizer) – and two adenovirus-based vaccines, one from Janssen (J&J) and the other from AstraZeneca. Five other COVID-19 vaccines are under review and may be available in the future.
All the currently available vaccines can be administered to patients with MS, including patients receiving immunosuppressant disease-modifying therapies, the statement notes.
In real-life clinical practice, no red flags have been observed for patients with MS who have received mRNA vaccines to date. Nevertheless, because immunocompromised patients and those taking immunomodulators were excluded from trials, continued surveillance for immune-mediated adverse effects is warranted, Dr. Farez said.
Regarding possible effects of vaccines on MS relapses/disability, no significant adverse effects occurred in a study conducted in Israel (by Achiron and colleagues) that involved 435 patients with MS who were fully vaccinated with the Pfizer mRNA vaccine. The relapse rate was 1.6%, similar to the rate among patients who did not have MS. A study by Di Filippo and colleagues showed no significant changes in relapse rate in the 2 months following immunization with the Pfizer vaccine among 324 patients with MS.
“There are no specific contraindications to any of the vaccines particularly for MS patients compared with the general population,” Dr. Farez noted.
Are there different recommendations for different MS therapies?
On the issue of vaccine effects in patients taking various disease-modifying treatments, the statement says that the data on this are limited. Patients taking interferons, glatiramer acetate, teriflunomide, and fumarates whose lymphocyte counts are normal will most likely be adequately protected. Patients with moderate to severe lymphopenia may not mount an adequate immune response to COVID-19 vaccination, so absolute lymphocyte count may be checked before vaccination.
Patients taking natalizumab will also likely be protected with COVID vaccination.
It is likely that for patients taking alemtuzumab, immune cellular and humoral response to COVID-10 vaccines will be attenuated, especially in the first 6 months during maximum lymphopenia. If possible, vaccination should be delayed until at least 6 months after treatment. It is thought that patients who have completed both courses of alemtuzumab with complete immune reconstitution will mount a full immune response.
In studies, all patients with MS who were treated with cladribine demonstrated a protective humoral immune response to the COVID-19 vaccine. In those studies, the antibody response was evident about 4 months after the last treatment dose, and the titer did not differ from that of healthy persons, Dr. Farez reported.
Low antibody level with fingolimod
The majority of patients treated with fingolimod have failed to show a protective level of antibodies following COVID-19 vaccination, the statement notes.
Asked whether patients taking fingolimod should receive a COVID vaccination, Dr. Farez said that that was a good question. “We have to think about what is an immune response. Antibodies are only a small fraction of all immune responses. So, until we have data to show otherwise, I think we should vaccinate – any immunity is better than no immunity,” he said.
Dr. Farez also suggested that patients with MS who are taking fingolimod should continue to do so. “Any treatment for MS is better than none. If fingolimod is stopped, MS may rebound. So, the most likely scenario would be to keep treating with fingolimod and to give the vaccination. But these patients may need a more aggressive booster approach – we will be looking at that,” he said.
Anti-CD20 antibody drugs
Patients taking ocrelizumab also do not mount an appropriate antibody response regardless of lymphocyte count or the time interval from the last ocrelizumab dose (3-9 months), the statement says. To optimize vaccine efficacy and to balance benefits and risks, the statement advises administering COVID vaccines at least 12 weeks after administering ocrelizumab and 4-6 weeks prior to the next dose, whenever possible.
A study by Apostolidis and colleagues provides strong evidence of immune priming by COVID vaccination in patients treated with anti-CD20 medications. Although for most of these patients, antibody responses are not optimal, T-cell priming is largely intact, Dr. Farez noted.
Booster doses/antibody tests
The need for and timing of COVID vaccine booster doses have not been established. “This is being discussed now for the general population. The recommendations for MS patients will not differ significantly from those for the general population, apart from perhaps for specific populations such as those on anti-CD20 drugs or fingolimod,” Dr. Farez said.
Antibody testing is not currently recommended for assessing immunity following COVID vaccination because the clinical utility and serologic correlates of protection after vaccination have not been established. Antibody testing does not evaluate the cellular immune response, which may play a role in vaccine-mediated protection, according to the statement.
Vaccination strategy after COVID
People should be offered vaccination regardless of their history of symptomatic or asymptomatic COVID-19, including people with prolonged post-COVID symptoms. Data from clinical trials indicate that the currently authorized vaccines can be given safely to people with evidence of prior SARS-CoV-2 infection. For people who are known to be currently infected with SARS-CoV-2, vaccination should be deferred until the acute illness has passed.
Pregnancy/children
Data on the safety of COVID vaccines during pregnancy are limited. On the basis of current knowledge, experts believe that it is unlikely that COVID vaccines pose a risk to the pregnant person or fetus, and thus pregnant people with MS are eligible for and can receive a COVID-19 vaccine, the statement notes.
Adolescents aged 12-17 are eligible to receive the authorized mRNA vaccine, but children younger than 12 are not authorized to receive any COVID vaccine at this time, it adds.
A version of this article first appeared on Medscape.com.
FROM ECTRIMS 2021
FDA approves cell-based flu shot for ages 6 months and older
The Food and Drug Administration has approved the Flucelvax quadrivalent vaccine for use in children aged 6 months and older, according to a statement from manufacturer Seqirus.
“This approval officially allows all eligible Americans to receive a cell-based influenza vaccine, increasing the potential for greater vaccine effectiveness,” according to the company.
The Centers for Disease Control and Prevention currently recommends annual influenza vaccination for all individuals aged 6 months and older without contraindications.
Flucelvax is manufactured using a cell-based process that yields a more precise match to the WHO-selected influenza strains for a given year. This process avoids the variation associated with traditional egg-based vaccines, and offers the potential for greater vaccine effectiveness, according to the company.
The approval was based in part on data from a phase 3 randomized, controlled noninferiority study of children aged 6-47 months. The data are the first for a cell-based flu vaccine in this age group, and were presented at the Pediatric Academic Societies meeting in 2021.
In the immunogenicity study of children aged 6 months through 3 years, described in the package insert, 1,597 children received Flucelvax quadrivalent and 805 received a control quadrivalent vaccine. After 28 days, Flucelvax showed noninferiority to the control quadrivalent against four influenza strains.
The most common side effects with Flucelvax quadrivalent vaccine overall are pain, redness, swelling, or a hardened area at the injection site, headache, low energy, muscle aches, and malaise. Additional side effects reported in children include tenderness or bruising at the injection site, sleepiness, diarrhea, changes in eating habits, and irritability. The vaccine is contraindicated for individuals with allergies to any of its ingredients.
Additional efficacy data on Flucelvax for children and adolescents aged 2-18 years were recently published in The New England Journal of Medicine.
Full prescribing information for Flucelvax is available here.
The FDA approval letter is available here.[email protected]
The Food and Drug Administration has approved the Flucelvax quadrivalent vaccine for use in children aged 6 months and older, according to a statement from manufacturer Seqirus.
“This approval officially allows all eligible Americans to receive a cell-based influenza vaccine, increasing the potential for greater vaccine effectiveness,” according to the company.
The Centers for Disease Control and Prevention currently recommends annual influenza vaccination for all individuals aged 6 months and older without contraindications.
Flucelvax is manufactured using a cell-based process that yields a more precise match to the WHO-selected influenza strains for a given year. This process avoids the variation associated with traditional egg-based vaccines, and offers the potential for greater vaccine effectiveness, according to the company.
The approval was based in part on data from a phase 3 randomized, controlled noninferiority study of children aged 6-47 months. The data are the first for a cell-based flu vaccine in this age group, and were presented at the Pediatric Academic Societies meeting in 2021.
In the immunogenicity study of children aged 6 months through 3 years, described in the package insert, 1,597 children received Flucelvax quadrivalent and 805 received a control quadrivalent vaccine. After 28 days, Flucelvax showed noninferiority to the control quadrivalent against four influenza strains.
The most common side effects with Flucelvax quadrivalent vaccine overall are pain, redness, swelling, or a hardened area at the injection site, headache, low energy, muscle aches, and malaise. Additional side effects reported in children include tenderness or bruising at the injection site, sleepiness, diarrhea, changes in eating habits, and irritability. The vaccine is contraindicated for individuals with allergies to any of its ingredients.
Additional efficacy data on Flucelvax for children and adolescents aged 2-18 years were recently published in The New England Journal of Medicine.
Full prescribing information for Flucelvax is available here.
The FDA approval letter is available here.[email protected]
The Food and Drug Administration has approved the Flucelvax quadrivalent vaccine for use in children aged 6 months and older, according to a statement from manufacturer Seqirus.
“This approval officially allows all eligible Americans to receive a cell-based influenza vaccine, increasing the potential for greater vaccine effectiveness,” according to the company.
The Centers for Disease Control and Prevention currently recommends annual influenza vaccination for all individuals aged 6 months and older without contraindications.
Flucelvax is manufactured using a cell-based process that yields a more precise match to the WHO-selected influenza strains for a given year. This process avoids the variation associated with traditional egg-based vaccines, and offers the potential for greater vaccine effectiveness, according to the company.
The approval was based in part on data from a phase 3 randomized, controlled noninferiority study of children aged 6-47 months. The data are the first for a cell-based flu vaccine in this age group, and were presented at the Pediatric Academic Societies meeting in 2021.
In the immunogenicity study of children aged 6 months through 3 years, described in the package insert, 1,597 children received Flucelvax quadrivalent and 805 received a control quadrivalent vaccine. After 28 days, Flucelvax showed noninferiority to the control quadrivalent against four influenza strains.
The most common side effects with Flucelvax quadrivalent vaccine overall are pain, redness, swelling, or a hardened area at the injection site, headache, low energy, muscle aches, and malaise. Additional side effects reported in children include tenderness or bruising at the injection site, sleepiness, diarrhea, changes in eating habits, and irritability. The vaccine is contraindicated for individuals with allergies to any of its ingredients.
Additional efficacy data on Flucelvax for children and adolescents aged 2-18 years were recently published in The New England Journal of Medicine.
Full prescribing information for Flucelvax is available here.
The FDA approval letter is available here.[email protected]
COVID-19: Can doctors refuse to see unvaccinated patients?
In June, Gerald Bock, MD, a dermatologist in central California, instituted a new office policy: He would not be seeing any more patients who remain unvaccinated against COVID-19 in his practice.
“[It is] the height of self-centered and irresponsible behavior,” he told me. “People who come in unvaccinated, when vaccination is widely available, are stating that their personal preferences are more important than their health, and are more important than any risk that they may expose their friends and family to, and also to any risk they might present to my staff and me. We have gone to considerable effort and expense to diminish any risk that visiting our office might entail. I see no reason why we should tolerate this.”
Other doctors appear to be following in his footsteps. There is no question that physicians have the right to choose their patients, just as patients are free to choose their doctors, but That is a complicated question without a clear answer. In a statement on whether physicians can decline unvaccinated patients, the American Medical Association continues to maintain that “in general” a physician may not “ethically turn a patient away based solely on the individual’s infectious disease status,” but does concede that “the decision to accept or decline a patient must balance the urgency of the individual patient’s need; the risk the patient may pose to other patients in the physician’s practice; and the need for the physician and staff, to be available to provide care in the future.”
Medical ethics experts have offered varying opinions. Daniel Wikler, PhD, professor of ethics and population health at the Harvard School of Public Health, Boston, wrote in an op-ed in the Washington Post that “ignorance or other personal failing” should not be factors in the evaluation of patients for health care. He argues that “doctors and hospitals are not in the blame and punishment business. Nor should they be. That doctors treat sinners and responsible citizens alike is a noble tradition.”
Timothy Hoff, professor of management, healthcare systems, and health policy at Northeastern University, Boston, maintains that, in nonemergency situations, physicians are legally able to refuse patients for a variety of reasons, provided they are not doing so because of some aspect of the patient’s race, gender, sexuality, or religion. However, in the same Northeastern University news release,Robert Baginski, MD, the director of interdisciplinary affairs for the department of medical sciences at Northeastern, cautions that it is vital for health authorities to continue urging the public to get vaccinated, but not at the expense of care.
Arthur L. Caplan, PhD, the head of the division of medical ethics at New York University, said in a Medscape commentary, that the decision to refuse to see patients who can vaccinate, but choose not to, is justifiable. “If you’re trying to protect yourself, your staff, or other patients, I think you do have the right to not take on somebody who won’t vaccinate,” he writes. “This is somewhat similar to when pediatricians do not accept a family if they won’t give their kids the state-required shots to go to school. That’s been happening for many years now.
“I also think it is morally justified if they won’t take your advice,” he continues. “If they won’t follow what you think is the best healthcare for them [such as getting vaccinated], there’s not much point in building that relationship.”
The situation is different in ED and hospital settings, however. “It’s a little harder to use unvaccinated status when someone really is at death’s door,” Dr. Caplan pointed out. “When someone comes in very sick, or whatever the reason, I think we have to take care of them ethically, and legally we’re bound to get them stable in the emergency room. I do think different rules apply there.”
In the end, every private practitioner will have to make his or her own decision on this question. Dr. Bock feels he made the right one. “Since instituting the policy, we have written 55 refund checks for people who had paid for a series of cosmetic procedures. We have no idea how many people were deterred from making appointments. We’ve had several negative online reviews and one woman who wrote a letter to the Medical Board of California complaining that we were discriminating against her,” he said. He added, however, that “we’ve also had several patients who commented favorably about the policy. I have no regrets about instituting the policy, and would do it again.”
Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].
In June, Gerald Bock, MD, a dermatologist in central California, instituted a new office policy: He would not be seeing any more patients who remain unvaccinated against COVID-19 in his practice.
“[It is] the height of self-centered and irresponsible behavior,” he told me. “People who come in unvaccinated, when vaccination is widely available, are stating that their personal preferences are more important than their health, and are more important than any risk that they may expose their friends and family to, and also to any risk they might present to my staff and me. We have gone to considerable effort and expense to diminish any risk that visiting our office might entail. I see no reason why we should tolerate this.”
Other doctors appear to be following in his footsteps. There is no question that physicians have the right to choose their patients, just as patients are free to choose their doctors, but That is a complicated question without a clear answer. In a statement on whether physicians can decline unvaccinated patients, the American Medical Association continues to maintain that “in general” a physician may not “ethically turn a patient away based solely on the individual’s infectious disease status,” but does concede that “the decision to accept or decline a patient must balance the urgency of the individual patient’s need; the risk the patient may pose to other patients in the physician’s practice; and the need for the physician and staff, to be available to provide care in the future.”
Medical ethics experts have offered varying opinions. Daniel Wikler, PhD, professor of ethics and population health at the Harvard School of Public Health, Boston, wrote in an op-ed in the Washington Post that “ignorance or other personal failing” should not be factors in the evaluation of patients for health care. He argues that “doctors and hospitals are not in the blame and punishment business. Nor should they be. That doctors treat sinners and responsible citizens alike is a noble tradition.”
Timothy Hoff, professor of management, healthcare systems, and health policy at Northeastern University, Boston, maintains that, in nonemergency situations, physicians are legally able to refuse patients for a variety of reasons, provided they are not doing so because of some aspect of the patient’s race, gender, sexuality, or religion. However, in the same Northeastern University news release,Robert Baginski, MD, the director of interdisciplinary affairs for the department of medical sciences at Northeastern, cautions that it is vital for health authorities to continue urging the public to get vaccinated, but not at the expense of care.
Arthur L. Caplan, PhD, the head of the division of medical ethics at New York University, said in a Medscape commentary, that the decision to refuse to see patients who can vaccinate, but choose not to, is justifiable. “If you’re trying to protect yourself, your staff, or other patients, I think you do have the right to not take on somebody who won’t vaccinate,” he writes. “This is somewhat similar to when pediatricians do not accept a family if they won’t give their kids the state-required shots to go to school. That’s been happening for many years now.
“I also think it is morally justified if they won’t take your advice,” he continues. “If they won’t follow what you think is the best healthcare for them [such as getting vaccinated], there’s not much point in building that relationship.”
The situation is different in ED and hospital settings, however. “It’s a little harder to use unvaccinated status when someone really is at death’s door,” Dr. Caplan pointed out. “When someone comes in very sick, or whatever the reason, I think we have to take care of them ethically, and legally we’re bound to get them stable in the emergency room. I do think different rules apply there.”
In the end, every private practitioner will have to make his or her own decision on this question. Dr. Bock feels he made the right one. “Since instituting the policy, we have written 55 refund checks for people who had paid for a series of cosmetic procedures. We have no idea how many people were deterred from making appointments. We’ve had several negative online reviews and one woman who wrote a letter to the Medical Board of California complaining that we were discriminating against her,” he said. He added, however, that “we’ve also had several patients who commented favorably about the policy. I have no regrets about instituting the policy, and would do it again.”
Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].
In June, Gerald Bock, MD, a dermatologist in central California, instituted a new office policy: He would not be seeing any more patients who remain unvaccinated against COVID-19 in his practice.
“[It is] the height of self-centered and irresponsible behavior,” he told me. “People who come in unvaccinated, when vaccination is widely available, are stating that their personal preferences are more important than their health, and are more important than any risk that they may expose their friends and family to, and also to any risk they might present to my staff and me. We have gone to considerable effort and expense to diminish any risk that visiting our office might entail. I see no reason why we should tolerate this.”
Other doctors appear to be following in his footsteps. There is no question that physicians have the right to choose their patients, just as patients are free to choose their doctors, but That is a complicated question without a clear answer. In a statement on whether physicians can decline unvaccinated patients, the American Medical Association continues to maintain that “in general” a physician may not “ethically turn a patient away based solely on the individual’s infectious disease status,” but does concede that “the decision to accept or decline a patient must balance the urgency of the individual patient’s need; the risk the patient may pose to other patients in the physician’s practice; and the need for the physician and staff, to be available to provide care in the future.”
Medical ethics experts have offered varying opinions. Daniel Wikler, PhD, professor of ethics and population health at the Harvard School of Public Health, Boston, wrote in an op-ed in the Washington Post that “ignorance or other personal failing” should not be factors in the evaluation of patients for health care. He argues that “doctors and hospitals are not in the blame and punishment business. Nor should they be. That doctors treat sinners and responsible citizens alike is a noble tradition.”
Timothy Hoff, professor of management, healthcare systems, and health policy at Northeastern University, Boston, maintains that, in nonemergency situations, physicians are legally able to refuse patients for a variety of reasons, provided they are not doing so because of some aspect of the patient’s race, gender, sexuality, or religion. However, in the same Northeastern University news release,Robert Baginski, MD, the director of interdisciplinary affairs for the department of medical sciences at Northeastern, cautions that it is vital for health authorities to continue urging the public to get vaccinated, but not at the expense of care.
Arthur L. Caplan, PhD, the head of the division of medical ethics at New York University, said in a Medscape commentary, that the decision to refuse to see patients who can vaccinate, but choose not to, is justifiable. “If you’re trying to protect yourself, your staff, or other patients, I think you do have the right to not take on somebody who won’t vaccinate,” he writes. “This is somewhat similar to when pediatricians do not accept a family if they won’t give their kids the state-required shots to go to school. That’s been happening for many years now.
“I also think it is morally justified if they won’t take your advice,” he continues. “If they won’t follow what you think is the best healthcare for them [such as getting vaccinated], there’s not much point in building that relationship.”
The situation is different in ED and hospital settings, however. “It’s a little harder to use unvaccinated status when someone really is at death’s door,” Dr. Caplan pointed out. “When someone comes in very sick, or whatever the reason, I think we have to take care of them ethically, and legally we’re bound to get them stable in the emergency room. I do think different rules apply there.”
In the end, every private practitioner will have to make his or her own decision on this question. Dr. Bock feels he made the right one. “Since instituting the policy, we have written 55 refund checks for people who had paid for a series of cosmetic procedures. We have no idea how many people were deterred from making appointments. We’ve had several negative online reviews and one woman who wrote a letter to the Medical Board of California complaining that we were discriminating against her,” he said. He added, however, that “we’ve also had several patients who commented favorably about the policy. I have no regrets about instituting the policy, and would do it again.”
Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a longtime monthly columnist for Dermatology News. Write to him at [email protected].
Paper linking COVID-19 vaccines to myocarditis is temporarily removed without explanation
The article, “A Report on Myocarditis Adverse Events in the U.S. Vaccine Adverse Events Reporting System (VAERS) in Association with COVID-19 Injectable Biological Products,” was published in Current Problems in Cardiology, an Elsevier journal, on October 1.
It was co-authored by Jessica Rose and Peter McCullough, whose affiliations are listed as the Public Health Policy Initiative at the Institute of Pure and Applied Knowledge — a group that has been critical of vaccines and of the response to COVID-19 and has funded one study that was retracted earlier this year — and Texas A&M’s Baylor Dallas campus. [See update at the end of the post.]
Last month, Baylor Scott & White obtained a restraining order against McCullough — whom Medscape says “has promoted the use of therapies seen as unproven for the treatment of COVID-19 and has questioned the effectiveness of COVID-19 vaccines” — for continuing to refer to an affiliation with the health care institution despite a separation agreement. “Since the Baylor suit, the Texas A&M College of Medicine, and the Texas Christian University (TCU) and University of North Texas Health Science Center (UNTHSC) School of Medicine have both removed McCullough from their faculties,” Medscape reported at the time.
Here are some highlights of the now temporarily retracted paper’s claims:
Within 8 weeks of the public offering of COVID-19 products to the 12-15-year-old age group, we found 19 times the expected number of myocarditis cases in the vaccination volunteers over background myocarditis rates for this age group. In addition, a 5-fold increase in myocarditis rate was observed subsequent to dose 2 as opposed to dose 1 in 15-year-old males.
While several studies have used the VAERS database and other similar datasets around the world to estimate rates of side effects from COVID-19 vaccines, the approach has been roundly criticized and has led to at least one retraction. VAERS itself includes caution against doing so. (Another paper about myocarditis cases linked to COVID-19 vaccines has been retracted for a serious math error.)
Here’s the notice:
The Publisher regrets that this article has been temporarily removed. A replacement will appear as soon as possible in which the reason for the removal of the article will be specified, or the article will be reinstated.
The full Elsevier Policy on Article Withdrawal can be found at http://www.elsevier.com/locate/withdrawalpolicy .
Rose, the corresponding author of the paper, told Retraction Watch that the publisher had “applied the ‘temporary withdrawal’ label to the paper without informing us.” The publisher, Rose said, “claimed that since ‘it wasn’t an invited paper’ that they were reconsidering publishing it and hence the ‘temporary withdrawal.’”
She said the move was “unheard of” and that Elsevier was “breaching the contract we signed – all fees have been paid for gorgeous color graphics.”
Elsevier has temporarily removed more than 100 papers since 2005, by our count. The papers are often reinstated without any mention of why the paper was removed.
Hector Ventura, the editor of the journal, did not immediately respond to a request for comment.
Update, 10/17/21, 1850 UTC: Rose tells us that the correct affiliations — now noted on the temporarily retracted version — are the Institute of Pure and Applied Knowledge’s Public Health Policy Initiative (PHPI) for her, and the Truth for Health Foundation in Tucson, Ariz. for McCullough. The foundation describes it mission as:
To provide truthful, balanced, medically sound, research-based information and cutting edge updates on prevention and treatment of common medical conditions, including COVID-19 and other infectious diseases, that affect health, quality of life and longevity.
To present faith-based integrated approaches to medical treatment, health and healing services that encompass all dimensions making us human: physical, psychological/emotional, spiritual, social and environmental.
The paper was submitted before McCullough’s departure from Baylor, Rose said.
A version of this article first appeared on Retraction Watch.
The article, “A Report on Myocarditis Adverse Events in the U.S. Vaccine Adverse Events Reporting System (VAERS) in Association with COVID-19 Injectable Biological Products,” was published in Current Problems in Cardiology, an Elsevier journal, on October 1.
It was co-authored by Jessica Rose and Peter McCullough, whose affiliations are listed as the Public Health Policy Initiative at the Institute of Pure and Applied Knowledge — a group that has been critical of vaccines and of the response to COVID-19 and has funded one study that was retracted earlier this year — and Texas A&M’s Baylor Dallas campus. [See update at the end of the post.]
Last month, Baylor Scott & White obtained a restraining order against McCullough — whom Medscape says “has promoted the use of therapies seen as unproven for the treatment of COVID-19 and has questioned the effectiveness of COVID-19 vaccines” — for continuing to refer to an affiliation with the health care institution despite a separation agreement. “Since the Baylor suit, the Texas A&M College of Medicine, and the Texas Christian University (TCU) and University of North Texas Health Science Center (UNTHSC) School of Medicine have both removed McCullough from their faculties,” Medscape reported at the time.
Here are some highlights of the now temporarily retracted paper’s claims:
Within 8 weeks of the public offering of COVID-19 products to the 12-15-year-old age group, we found 19 times the expected number of myocarditis cases in the vaccination volunteers over background myocarditis rates for this age group. In addition, a 5-fold increase in myocarditis rate was observed subsequent to dose 2 as opposed to dose 1 in 15-year-old males.
While several studies have used the VAERS database and other similar datasets around the world to estimate rates of side effects from COVID-19 vaccines, the approach has been roundly criticized and has led to at least one retraction. VAERS itself includes caution against doing so. (Another paper about myocarditis cases linked to COVID-19 vaccines has been retracted for a serious math error.)
Here’s the notice:
The Publisher regrets that this article has been temporarily removed. A replacement will appear as soon as possible in which the reason for the removal of the article will be specified, or the article will be reinstated.
The full Elsevier Policy on Article Withdrawal can be found at http://www.elsevier.com/locate/withdrawalpolicy .
Rose, the corresponding author of the paper, told Retraction Watch that the publisher had “applied the ‘temporary withdrawal’ label to the paper without informing us.” The publisher, Rose said, “claimed that since ‘it wasn’t an invited paper’ that they were reconsidering publishing it and hence the ‘temporary withdrawal.’”
She said the move was “unheard of” and that Elsevier was “breaching the contract we signed – all fees have been paid for gorgeous color graphics.”
Elsevier has temporarily removed more than 100 papers since 2005, by our count. The papers are often reinstated without any mention of why the paper was removed.
Hector Ventura, the editor of the journal, did not immediately respond to a request for comment.
Update, 10/17/21, 1850 UTC: Rose tells us that the correct affiliations — now noted on the temporarily retracted version — are the Institute of Pure and Applied Knowledge’s Public Health Policy Initiative (PHPI) for her, and the Truth for Health Foundation in Tucson, Ariz. for McCullough. The foundation describes it mission as:
To provide truthful, balanced, medically sound, research-based information and cutting edge updates on prevention and treatment of common medical conditions, including COVID-19 and other infectious diseases, that affect health, quality of life and longevity.
To present faith-based integrated approaches to medical treatment, health and healing services that encompass all dimensions making us human: physical, psychological/emotional, spiritual, social and environmental.
The paper was submitted before McCullough’s departure from Baylor, Rose said.
A version of this article first appeared on Retraction Watch.
The article, “A Report on Myocarditis Adverse Events in the U.S. Vaccine Adverse Events Reporting System (VAERS) in Association with COVID-19 Injectable Biological Products,” was published in Current Problems in Cardiology, an Elsevier journal, on October 1.
It was co-authored by Jessica Rose and Peter McCullough, whose affiliations are listed as the Public Health Policy Initiative at the Institute of Pure and Applied Knowledge — a group that has been critical of vaccines and of the response to COVID-19 and has funded one study that was retracted earlier this year — and Texas A&M’s Baylor Dallas campus. [See update at the end of the post.]
Last month, Baylor Scott & White obtained a restraining order against McCullough — whom Medscape says “has promoted the use of therapies seen as unproven for the treatment of COVID-19 and has questioned the effectiveness of COVID-19 vaccines” — for continuing to refer to an affiliation with the health care institution despite a separation agreement. “Since the Baylor suit, the Texas A&M College of Medicine, and the Texas Christian University (TCU) and University of North Texas Health Science Center (UNTHSC) School of Medicine have both removed McCullough from their faculties,” Medscape reported at the time.
Here are some highlights of the now temporarily retracted paper’s claims:
Within 8 weeks of the public offering of COVID-19 products to the 12-15-year-old age group, we found 19 times the expected number of myocarditis cases in the vaccination volunteers over background myocarditis rates for this age group. In addition, a 5-fold increase in myocarditis rate was observed subsequent to dose 2 as opposed to dose 1 in 15-year-old males.
While several studies have used the VAERS database and other similar datasets around the world to estimate rates of side effects from COVID-19 vaccines, the approach has been roundly criticized and has led to at least one retraction. VAERS itself includes caution against doing so. (Another paper about myocarditis cases linked to COVID-19 vaccines has been retracted for a serious math error.)
Here’s the notice:
The Publisher regrets that this article has been temporarily removed. A replacement will appear as soon as possible in which the reason for the removal of the article will be specified, or the article will be reinstated.
The full Elsevier Policy on Article Withdrawal can be found at http://www.elsevier.com/locate/withdrawalpolicy .
Rose, the corresponding author of the paper, told Retraction Watch that the publisher had “applied the ‘temporary withdrawal’ label to the paper without informing us.” The publisher, Rose said, “claimed that since ‘it wasn’t an invited paper’ that they were reconsidering publishing it and hence the ‘temporary withdrawal.’”
She said the move was “unheard of” and that Elsevier was “breaching the contract we signed – all fees have been paid for gorgeous color graphics.”
Elsevier has temporarily removed more than 100 papers since 2005, by our count. The papers are often reinstated without any mention of why the paper was removed.
Hector Ventura, the editor of the journal, did not immediately respond to a request for comment.
Update, 10/17/21, 1850 UTC: Rose tells us that the correct affiliations — now noted on the temporarily retracted version — are the Institute of Pure and Applied Knowledge’s Public Health Policy Initiative (PHPI) for her, and the Truth for Health Foundation in Tucson, Ariz. for McCullough. The foundation describes it mission as:
To provide truthful, balanced, medically sound, research-based information and cutting edge updates on prevention and treatment of common medical conditions, including COVID-19 and other infectious diseases, that affect health, quality of life and longevity.
To present faith-based integrated approaches to medical treatment, health and healing services that encompass all dimensions making us human: physical, psychological/emotional, spiritual, social and environmental.
The paper was submitted before McCullough’s departure from Baylor, Rose said.
A version of this article first appeared on Retraction Watch.
Could your patient benefit? New trials in lung cancer
Untreated PD-L1 non–small cell lung cancer (NSCLC). comparing pembrolizumab to the investigational immunotherapies ociperlimab (an anti-TIGIT antibody) and tislelizumab (an anti-PD-1 checkpoint inhibitor). Participants will be treated until death or progression of disease, whichever comes first, up to approximately 39 months. The multinational study started recruiting June 8 and hopes to enroll 605 participants. U.S. trial centers are in Alabama, Alaska, California, Florida, Hawaii, Kentucky, Maine, and Virginia. Overall survival (OS) is a primary outcome, and quality of life (QoL) will be tracked. More details are avaiable at clinicaltrials.gov.
Newly diagnosed, locally advanced, unresectable NSCLC. Adult patients with newly diagnosed, histologically confirmed, locally advanced, stage III unresectable NSCL are being recruited for a phase 3 study comparing sequential combinations of concurrent chemoradiotherapy and the immunotherapies ociperlimab, tislelizumab, and durvalumab (Imfinzi). Participants will receive therapy until disease progression or up to 16 months from randomization, whichever occurs first. The trial began recruiting on June 17 at the Central Care Cancer Center, in Bolivar, Mo. OS and QoL over 16 months are secondary outcomes. More details are avaiable at clinicaltrials.gov.
Limited-stage small cell lung cancer. Patients with untreated small cell lung cancer and documented limited-stage disease (stages Tx, T1-T4, N0-3, M0; AJCC staging, eighth edition) can join a phase 2 study comparing the immunotherapies ociperlimab and tislelizumab plus concurrent chemoradiotherapy to concurrent chemoradiotherapy alone. The trial will last 30 months from the date of the study’s first recruitment. Investigators are aiming to recruit 120 people globally. U.S. sites are in Alaska, Hawaii, Kansas, Missouri, Pennsylvania, Texas, and Wisconsin. Progression-free survival is the primary outcome. OS over 30 months is a secondary outcome. QoL will not be tracked. More details are avaiable at clinicaltrials.gov.
Stage III unresectable NSCLC. Patients with stage III unresectable NSCLC with positive circulating tumor DNA are being recruited for a phase 3 study testing whether or not circulating cancer cells in the blood can be decreased by combining standard treatment durvalumab with platinum-doublet chemotherapy (carboplatin/pemetrexed or carboplatin/paclitaxel). Patients will receive durvalumab for 1 year, with or without four cycles of chemotherapy. The study opened on August 25 at Stanford University, in California. OS over 2 years is a secondary outcome. QoL will not be assessed. More details are avaiable at clinicaltrials.gov.
Untreated stage IV NSCLC. Patients with nonsquamous stage IV NSCLC not treated for metastatic disease are being recruited for a phase 2 study of the experimental immunotherapy SEA-CD40 in combination with pembrolizumab, pemetrexed, and carboplatin. Participants will be treated for approximately 2 years. Objective response rate is the primary outcome. OS over 4 years is a secondary outcome. QoL will not be assessed. The study opened on September 30 in Arkansas, California, Minnesota, Ohio, and Texas. More details are avaiable at clinicaltrials.gov.
Untreated metastatic NSCLC. Patients with metastatic squamous or nonsquamous NSCLC are sought for a phase 3 trial that will compare a new subcutaneous formulation of pembrolizumab with standard intravenous pembrolizumab, both given in combination with chemotherapy. Patients will be treated with immunotherapy for up to approximately 2 years until the occurrence of disease progression or intolerable adverse events or the participant/physician decides to stop. Drug pharmacokinetic performance is the primary outcome measure. OS over 5 years will be analyzed as a secondary outcome. QoL will not be assessed. The international trial has U.S. sites in Florida, Montana, Tennessee, Texas, and Virginia. More details are available at clinicaltrials.gov.
All trial information is from the National Institutes of Health U.S. National Library of Medicine (online at clinicaltrials.gov).
A version of this article first appeared on Medscape.com.
Untreated PD-L1 non–small cell lung cancer (NSCLC). comparing pembrolizumab to the investigational immunotherapies ociperlimab (an anti-TIGIT antibody) and tislelizumab (an anti-PD-1 checkpoint inhibitor). Participants will be treated until death or progression of disease, whichever comes first, up to approximately 39 months. The multinational study started recruiting June 8 and hopes to enroll 605 participants. U.S. trial centers are in Alabama, Alaska, California, Florida, Hawaii, Kentucky, Maine, and Virginia. Overall survival (OS) is a primary outcome, and quality of life (QoL) will be tracked. More details are avaiable at clinicaltrials.gov.
Newly diagnosed, locally advanced, unresectable NSCLC. Adult patients with newly diagnosed, histologically confirmed, locally advanced, stage III unresectable NSCL are being recruited for a phase 3 study comparing sequential combinations of concurrent chemoradiotherapy and the immunotherapies ociperlimab, tislelizumab, and durvalumab (Imfinzi). Participants will receive therapy until disease progression or up to 16 months from randomization, whichever occurs first. The trial began recruiting on June 17 at the Central Care Cancer Center, in Bolivar, Mo. OS and QoL over 16 months are secondary outcomes. More details are avaiable at clinicaltrials.gov.
Limited-stage small cell lung cancer. Patients with untreated small cell lung cancer and documented limited-stage disease (stages Tx, T1-T4, N0-3, M0; AJCC staging, eighth edition) can join a phase 2 study comparing the immunotherapies ociperlimab and tislelizumab plus concurrent chemoradiotherapy to concurrent chemoradiotherapy alone. The trial will last 30 months from the date of the study’s first recruitment. Investigators are aiming to recruit 120 people globally. U.S. sites are in Alaska, Hawaii, Kansas, Missouri, Pennsylvania, Texas, and Wisconsin. Progression-free survival is the primary outcome. OS over 30 months is a secondary outcome. QoL will not be tracked. More details are avaiable at clinicaltrials.gov.
Stage III unresectable NSCLC. Patients with stage III unresectable NSCLC with positive circulating tumor DNA are being recruited for a phase 3 study testing whether or not circulating cancer cells in the blood can be decreased by combining standard treatment durvalumab with platinum-doublet chemotherapy (carboplatin/pemetrexed or carboplatin/paclitaxel). Patients will receive durvalumab for 1 year, with or without four cycles of chemotherapy. The study opened on August 25 at Stanford University, in California. OS over 2 years is a secondary outcome. QoL will not be assessed. More details are avaiable at clinicaltrials.gov.
Untreated stage IV NSCLC. Patients with nonsquamous stage IV NSCLC not treated for metastatic disease are being recruited for a phase 2 study of the experimental immunotherapy SEA-CD40 in combination with pembrolizumab, pemetrexed, and carboplatin. Participants will be treated for approximately 2 years. Objective response rate is the primary outcome. OS over 4 years is a secondary outcome. QoL will not be assessed. The study opened on September 30 in Arkansas, California, Minnesota, Ohio, and Texas. More details are avaiable at clinicaltrials.gov.
Untreated metastatic NSCLC. Patients with metastatic squamous or nonsquamous NSCLC are sought for a phase 3 trial that will compare a new subcutaneous formulation of pembrolizumab with standard intravenous pembrolizumab, both given in combination with chemotherapy. Patients will be treated with immunotherapy for up to approximately 2 years until the occurrence of disease progression or intolerable adverse events or the participant/physician decides to stop. Drug pharmacokinetic performance is the primary outcome measure. OS over 5 years will be analyzed as a secondary outcome. QoL will not be assessed. The international trial has U.S. sites in Florida, Montana, Tennessee, Texas, and Virginia. More details are available at clinicaltrials.gov.
All trial information is from the National Institutes of Health U.S. National Library of Medicine (online at clinicaltrials.gov).
A version of this article first appeared on Medscape.com.
Untreated PD-L1 non–small cell lung cancer (NSCLC). comparing pembrolizumab to the investigational immunotherapies ociperlimab (an anti-TIGIT antibody) and tislelizumab (an anti-PD-1 checkpoint inhibitor). Participants will be treated until death or progression of disease, whichever comes first, up to approximately 39 months. The multinational study started recruiting June 8 and hopes to enroll 605 participants. U.S. trial centers are in Alabama, Alaska, California, Florida, Hawaii, Kentucky, Maine, and Virginia. Overall survival (OS) is a primary outcome, and quality of life (QoL) will be tracked. More details are avaiable at clinicaltrials.gov.
Newly diagnosed, locally advanced, unresectable NSCLC. Adult patients with newly diagnosed, histologically confirmed, locally advanced, stage III unresectable NSCL are being recruited for a phase 3 study comparing sequential combinations of concurrent chemoradiotherapy and the immunotherapies ociperlimab, tislelizumab, and durvalumab (Imfinzi). Participants will receive therapy until disease progression or up to 16 months from randomization, whichever occurs first. The trial began recruiting on June 17 at the Central Care Cancer Center, in Bolivar, Mo. OS and QoL over 16 months are secondary outcomes. More details are avaiable at clinicaltrials.gov.
Limited-stage small cell lung cancer. Patients with untreated small cell lung cancer and documented limited-stage disease (stages Tx, T1-T4, N0-3, M0; AJCC staging, eighth edition) can join a phase 2 study comparing the immunotherapies ociperlimab and tislelizumab plus concurrent chemoradiotherapy to concurrent chemoradiotherapy alone. The trial will last 30 months from the date of the study’s first recruitment. Investigators are aiming to recruit 120 people globally. U.S. sites are in Alaska, Hawaii, Kansas, Missouri, Pennsylvania, Texas, and Wisconsin. Progression-free survival is the primary outcome. OS over 30 months is a secondary outcome. QoL will not be tracked. More details are avaiable at clinicaltrials.gov.
Stage III unresectable NSCLC. Patients with stage III unresectable NSCLC with positive circulating tumor DNA are being recruited for a phase 3 study testing whether or not circulating cancer cells in the blood can be decreased by combining standard treatment durvalumab with platinum-doublet chemotherapy (carboplatin/pemetrexed or carboplatin/paclitaxel). Patients will receive durvalumab for 1 year, with or without four cycles of chemotherapy. The study opened on August 25 at Stanford University, in California. OS over 2 years is a secondary outcome. QoL will not be assessed. More details are avaiable at clinicaltrials.gov.
Untreated stage IV NSCLC. Patients with nonsquamous stage IV NSCLC not treated for metastatic disease are being recruited for a phase 2 study of the experimental immunotherapy SEA-CD40 in combination with pembrolizumab, pemetrexed, and carboplatin. Participants will be treated for approximately 2 years. Objective response rate is the primary outcome. OS over 4 years is a secondary outcome. QoL will not be assessed. The study opened on September 30 in Arkansas, California, Minnesota, Ohio, and Texas. More details are avaiable at clinicaltrials.gov.
Untreated metastatic NSCLC. Patients with metastatic squamous or nonsquamous NSCLC are sought for a phase 3 trial that will compare a new subcutaneous formulation of pembrolizumab with standard intravenous pembrolizumab, both given in combination with chemotherapy. Patients will be treated with immunotherapy for up to approximately 2 years until the occurrence of disease progression or intolerable adverse events or the participant/physician decides to stop. Drug pharmacokinetic performance is the primary outcome measure. OS over 5 years will be analyzed as a secondary outcome. QoL will not be assessed. The international trial has U.S. sites in Florida, Montana, Tennessee, Texas, and Virginia. More details are available at clinicaltrials.gov.
All trial information is from the National Institutes of Health U.S. National Library of Medicine (online at clinicaltrials.gov).
A version of this article first appeared on Medscape.com.