Journal of Clinical Outcomes Management

The recall of extended-release metformin continues this month as 76 more lots have been flagged for a possible cancer-causing ingredient.

The Food and Drug Administration announced the latest recall, involving Marksans Pharma Limited and Sun Pharmaceutical Industries products, on Oct. 5. It involves the 500-mg and 700-mg tablets. More than 175 different drug combinations have been recalled since late May.

Consumers can see all the recalled metformin products at this FDA website. The agency says that immediate-release metformin does not appear to have the same contamination problem.

The FDA has been investigating the presence of nitrosamines, known to be possible carcinogens, in the popular diabetes medications since December, when they were first discovered in drugs in other countries. The agency said this month they still do not know the source of nitrosamines in the medications.

The investigation and subsequent recalls follow similar ones for contamination of popular heartburn and blood pressure drugs also for nitrosamines, such as N-Nitrosodimethylamine (NDMA).

The FDA says patients taking metformin products that have been recalled should continue taking the medication until a doctor or pharmacist gives them a replacement or a different treatment option. It could be dangerous for patients with type 2 diabetes to stop taking the medication without first talking to their doctor.

The agency has asked drug manufacturers to test products before batches are released into the market. The companies must tell the FDA if any product shows levels of nitrosamines above the acceptable limit.

The risk from nitrosamines is not clear. The FDA says they may increase the risk of cancer in people who are exposed to high levels over a long period of time, “but we do not anticipate that shorter-term exposure at levels above the acceptable intake limit would lead to an increase in the risk of cancer.”
 

This article first appeared on WebMD.com.

The recall of extended-release metformin continues this month as 76 more lots have been flagged for a possible cancer-causing ingredient.

The Food and Drug Administration announced the latest recall, involving Marksans Pharma Limited and Sun Pharmaceutical Industries products, on Oct. 5. It involves the 500-mg and 700-mg tablets. More than 175 different drug combinations have been recalled since late May.

Consumers can see all the recalled metformin products at this FDA website. The agency says that immediate-release metformin does not appear to have the same contamination problem.

The FDA has been investigating the presence of nitrosamines, known to be possible carcinogens, in the popular diabetes medications since December, when they were first discovered in drugs in other countries. The agency said this month they still do not know the source of nitrosamines in the medications.

The investigation and subsequent recalls follow similar ones for contamination of popular heartburn and blood pressure drugs also for nitrosamines, such as N-Nitrosodimethylamine (NDMA).

The FDA says patients taking metformin products that have been recalled should continue taking the medication until a doctor or pharmacist gives them a replacement or a different treatment option. It could be dangerous for patients with type 2 diabetes to stop taking the medication without first talking to their doctor.

The agency has asked drug manufacturers to test products before batches are released into the market. The companies must tell the FDA if any product shows levels of nitrosamines above the acceptable limit.

The risk from nitrosamines is not clear. The FDA says they may increase the risk of cancer in people who are exposed to high levels over a long period of time, “but we do not anticipate that shorter-term exposure at levels above the acceptable intake limit would lead to an increase in the risk of cancer.”
 

This article first appeared on WebMD.com.

The recall of extended-release metformin continues this month as 76 more lots have been flagged for a possible cancer-causing ingredient.

The Food and Drug Administration announced the latest recall, involving Marksans Pharma Limited and Sun Pharmaceutical Industries products, on Oct. 5. It involves the 500-mg and 700-mg tablets. More than 175 different drug combinations have been recalled since late May.

Consumers can see all the recalled metformin products at this FDA website. The agency says that immediate-release metformin does not appear to have the same contamination problem.

The FDA has been investigating the presence of nitrosamines, known to be possible carcinogens, in the popular diabetes medications since December, when they were first discovered in drugs in other countries. The agency said this month they still do not know the source of nitrosamines in the medications.

The investigation and subsequent recalls follow similar ones for contamination of popular heartburn and blood pressure drugs also for nitrosamines, such as N-Nitrosodimethylamine (NDMA).

The FDA says patients taking metformin products that have been recalled should continue taking the medication until a doctor or pharmacist gives them a replacement or a different treatment option. It could be dangerous for patients with type 2 diabetes to stop taking the medication without first talking to their doctor.

The agency has asked drug manufacturers to test products before batches are released into the market. The companies must tell the FDA if any product shows levels of nitrosamines above the acceptable limit.

The risk from nitrosamines is not clear. The FDA says they may increase the risk of cancer in people who are exposed to high levels over a long period of time, “but we do not anticipate that shorter-term exposure at levels above the acceptable intake limit would lead to an increase in the risk of cancer.”
 

This article first appeared on WebMD.com.

Patients with COVID-19 who present with ST-segment elevation MI (STEMI) represent a unique, high-risk population with greater risks for in-hospital death and stroke, according to initial results from the North American COVID-19 ST-Segment Elevation Myocardial Infarction Registry (NACMI).

Although COVID-19–confirmed patients were less likely to undergo angiography than patients under investigation (PUI) for COVID-19 or historical STEMI activation controls, 71% underwent primary percutaneous coronary intervention (PCI).

“Primary PCI is preferable and feasible in COVID-19–positive patients, with door-to-balloon times similar to PUI or COVID-negative patients, and that supports the updated COVID-specific STEMI guidelines,” study cochair Timothy D. Henry, MD, said in a late-breaking clinical science session at TCT 2020, the Transcatheter Cardiovascular Therapeutics virtual annual meeting.

The multisociety COVID-specific guidelines were initially issued in April, endorsing PCI as the standard of care and allowing for consideration of fibrinolysis-based therapy at non-PCI capable hospitals.

Five previous publications on a total of 174 COVID-19 patients with ST-elevation have shown there are more frequent in-hospital STEMI presentations, more cases without a clear culprit lesion, more thrombotic lesions and microthrombi, and higher mortality, ranging from 12% to 72%. Still, there has been considerable controversy over exactly what to do when COVID-19 patients with ST elevation reach the cath lab, he said at the meeting sponsored by the Cardiovascular Research Foundation.

NACMI represents the largest experience with ST-elevation patients and is a unique collaboration between the Society for Cardiovascular Angiography and Interventions, Canadian Association of Interventional Cardiology, American College of Cardiology, and Midwest STEMI Consortium, noted Dr. Henry, who is medical director of the Lindner Center for Research and Education at the Christ Hospital, Cincinnati.

The registry enrolled any COVID-19–positive patient or person under investigation older than 18 years with ST-segment elevation or new-onset left bundle branch block on electrocardiogram with a clinical correlate of myocardial ischemia such as chest pain, dyspnea, cardiac arrest, shock, or mechanical ventilation. There were no exclusion criteria.

Data from 171 patients with confirmed COVID-19 and 423 PUI from 64 sites were then propensity-matched to a control population from the Midwest STEMI Consortium, a prospective, multicenter registry of consecutive STEMI patients.

The three groups were similar in sex and age but there was a striking difference in race, with 27% of African American and 24% of Hispanic patients COVID-confirmed, compared with 11% and 6% in the PUI group and 4% and 1% in the control group. Likewise, there was a significant increase in diabetes (44% vs. 33% vs. 20%), which has been reported previously with influenza.

COVID-19–positive patients, as compared with PUI and controls, were significantly more likely to present with cardiogenic shock before PCI (20% vs. 14% vs. 5%), but not cardiac arrest (12% vs. 17% vs. 11%), and to have lower left ventricular ejection fractions (45% vs. 45% vs. 50%).

They also presented with more atypical symptoms than PUI patients, particularly infiltrates on chest x-ray (49% vs. 17%) and dyspnea (58% vs. 38%). Data were not available for these outcomes among historic controls.

Importantly, 21% of the COVID-19 patients did not undergo angiography, compared with 5% of PUI patients and 0% of controls (P < .001), “which is much higher than we would expect or have suspected,” Dr. Henry said. Thrombolytic use was very uncommon in those undergoing angiography, likely as a result of the guidelines.

Very surprisingly, there were no differences in door-to-balloon times between the COVID-positive, PUI, and control groups despite the ongoing pandemic (80 min vs. 78 min vs. 86 min).

But there was clear worsening in in-hospital mortality in COVID-19–positive patients (32% vs. 12% and 6%; P < .001), as well as in-hospital stroke (3.4% vs. 2% vs. 0.6%) that reached statistical significance only when compared with historical controls (P = .039). Total length of stay was twice as long in COVID-confirmed patients as in both PUI and controls (6 days vs. 3 days; P < .001).

Following the formal presentation, invited discussant Philippe Gabriel Steg, MD, Imperial College London, said the researchers have provided a great service in reporting the data so quickly but noted that an ongoing French registry of events before, during, and after the first COVID-19 wave has not seen an increased death rate.

“Can you tease out whether the increased death rate is related to cardiovascular deaths or to COVID-related pneumonias, shocks, ARDSs [acute respiratory distress syndromes], and so on and so forth? Because our impression – and that’s what we’ve published in Lancet Public Health – is that the cardiovascular morality rate doesn’t seem that affected by COVID.”

Dr. Henry replied that these are early data but “I will tell you that patients who did get PCI had a mortality rate that was only around 12% or 13%, and the patients who did not undergo angiography or were treated with medical therapy had higher mortality. Now, of course, that’s selected and we need to do a much better matching and look at that, but that’s our goal and we will have that information,” he said.

During a press briefing on the study, discussant Renu Virmani, MD, president and founder of CVPath Institute, noted that, in their analysis of 40 autopsy cases from Bergamot, Italy, small intramyocardial microthrombi were seen in nine patients, whereas epicardial microthrombi were seen in only three or four.

“Some of the cases are being taken as being related to coronary disease but may be more thrombotic than anything else,” she said. “I think there’s a combination, and that’s why the outcomes are so poor. You didn’t show us TIMI flow but that’s something to think about: Was TIMI flow different in the patients who died because you have very high mortality? I think we need to get to the bottom of what is the underlying cause of that thrombosis.”

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

Patients with COVID-19 who present with ST-segment elevation MI (STEMI) represent a unique, high-risk population with greater risks for in-hospital death and stroke, according to initial results from the North American COVID-19 ST-Segment Elevation Myocardial Infarction Registry (NACMI).

Although COVID-19–confirmed patients were less likely to undergo angiography than patients under investigation (PUI) for COVID-19 or historical STEMI activation controls, 71% underwent primary percutaneous coronary intervention (PCI).

“Primary PCI is preferable and feasible in COVID-19–positive patients, with door-to-balloon times similar to PUI or COVID-negative patients, and that supports the updated COVID-specific STEMI guidelines,” study cochair Timothy D. Henry, MD, said in a late-breaking clinical science session at TCT 2020, the Transcatheter Cardiovascular Therapeutics virtual annual meeting.

The multisociety COVID-specific guidelines were initially issued in April, endorsing PCI as the standard of care and allowing for consideration of fibrinolysis-based therapy at non-PCI capable hospitals.

Five previous publications on a total of 174 COVID-19 patients with ST-elevation have shown there are more frequent in-hospital STEMI presentations, more cases without a clear culprit lesion, more thrombotic lesions and microthrombi, and higher mortality, ranging from 12% to 72%. Still, there has been considerable controversy over exactly what to do when COVID-19 patients with ST elevation reach the cath lab, he said at the meeting sponsored by the Cardiovascular Research Foundation.

NACMI represents the largest experience with ST-elevation patients and is a unique collaboration between the Society for Cardiovascular Angiography and Interventions, Canadian Association of Interventional Cardiology, American College of Cardiology, and Midwest STEMI Consortium, noted Dr. Henry, who is medical director of the Lindner Center for Research and Education at the Christ Hospital, Cincinnati.

The registry enrolled any COVID-19–positive patient or person under investigation older than 18 years with ST-segment elevation or new-onset left bundle branch block on electrocardiogram with a clinical correlate of myocardial ischemia such as chest pain, dyspnea, cardiac arrest, shock, or mechanical ventilation. There were no exclusion criteria.

Data from 171 patients with confirmed COVID-19 and 423 PUI from 64 sites were then propensity-matched to a control population from the Midwest STEMI Consortium, a prospective, multicenter registry of consecutive STEMI patients.

The three groups were similar in sex and age but there was a striking difference in race, with 27% of African American and 24% of Hispanic patients COVID-confirmed, compared with 11% and 6% in the PUI group and 4% and 1% in the control group. Likewise, there was a significant increase in diabetes (44% vs. 33% vs. 20%), which has been reported previously with influenza.

COVID-19–positive patients, as compared with PUI and controls, were significantly more likely to present with cardiogenic shock before PCI (20% vs. 14% vs. 5%), but not cardiac arrest (12% vs. 17% vs. 11%), and to have lower left ventricular ejection fractions (45% vs. 45% vs. 50%).

They also presented with more atypical symptoms than PUI patients, particularly infiltrates on chest x-ray (49% vs. 17%) and dyspnea (58% vs. 38%). Data were not available for these outcomes among historic controls.

Importantly, 21% of the COVID-19 patients did not undergo angiography, compared with 5% of PUI patients and 0% of controls (P < .001), “which is much higher than we would expect or have suspected,” Dr. Henry said. Thrombolytic use was very uncommon in those undergoing angiography, likely as a result of the guidelines.

Very surprisingly, there were no differences in door-to-balloon times between the COVID-positive, PUI, and control groups despite the ongoing pandemic (80 min vs. 78 min vs. 86 min).

But there was clear worsening in in-hospital mortality in COVID-19–positive patients (32% vs. 12% and 6%; P < .001), as well as in-hospital stroke (3.4% vs. 2% vs. 0.6%) that reached statistical significance only when compared with historical controls (P = .039). Total length of stay was twice as long in COVID-confirmed patients as in both PUI and controls (6 days vs. 3 days; P < .001).

Following the formal presentation, invited discussant Philippe Gabriel Steg, MD, Imperial College London, said the researchers have provided a great service in reporting the data so quickly but noted that an ongoing French registry of events before, during, and after the first COVID-19 wave has not seen an increased death rate.

“Can you tease out whether the increased death rate is related to cardiovascular deaths or to COVID-related pneumonias, shocks, ARDSs [acute respiratory distress syndromes], and so on and so forth? Because our impression – and that’s what we’ve published in Lancet Public Health – is that the cardiovascular morality rate doesn’t seem that affected by COVID.”

Dr. Henry replied that these are early data but “I will tell you that patients who did get PCI had a mortality rate that was only around 12% or 13%, and the patients who did not undergo angiography or were treated with medical therapy had higher mortality. Now, of course, that’s selected and we need to do a much better matching and look at that, but that’s our goal and we will have that information,” he said.

During a press briefing on the study, discussant Renu Virmani, MD, president and founder of CVPath Institute, noted that, in their analysis of 40 autopsy cases from Bergamot, Italy, small intramyocardial microthrombi were seen in nine patients, whereas epicardial microthrombi were seen in only three or four.

“Some of the cases are being taken as being related to coronary disease but may be more thrombotic than anything else,” she said. “I think there’s a combination, and that’s why the outcomes are so poor. You didn’t show us TIMI flow but that’s something to think about: Was TIMI flow different in the patients who died because you have very high mortality? I think we need to get to the bottom of what is the underlying cause of that thrombosis.”

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

Patients with COVID-19 who present with ST-segment elevation MI (STEMI) represent a unique, high-risk population with greater risks for in-hospital death and stroke, according to initial results from the North American COVID-19 ST-Segment Elevation Myocardial Infarction Registry (NACMI).

Although COVID-19–confirmed patients were less likely to undergo angiography than patients under investigation (PUI) for COVID-19 or historical STEMI activation controls, 71% underwent primary percutaneous coronary intervention (PCI).

“Primary PCI is preferable and feasible in COVID-19–positive patients, with door-to-balloon times similar to PUI or COVID-negative patients, and that supports the updated COVID-specific STEMI guidelines,” study cochair Timothy D. Henry, MD, said in a late-breaking clinical science session at TCT 2020, the Transcatheter Cardiovascular Therapeutics virtual annual meeting.

The multisociety COVID-specific guidelines were initially issued in April, endorsing PCI as the standard of care and allowing for consideration of fibrinolysis-based therapy at non-PCI capable hospitals.

Five previous publications on a total of 174 COVID-19 patients with ST-elevation have shown there are more frequent in-hospital STEMI presentations, more cases without a clear culprit lesion, more thrombotic lesions and microthrombi, and higher mortality, ranging from 12% to 72%. Still, there has been considerable controversy over exactly what to do when COVID-19 patients with ST elevation reach the cath lab, he said at the meeting sponsored by the Cardiovascular Research Foundation.

NACMI represents the largest experience with ST-elevation patients and is a unique collaboration between the Society for Cardiovascular Angiography and Interventions, Canadian Association of Interventional Cardiology, American College of Cardiology, and Midwest STEMI Consortium, noted Dr. Henry, who is medical director of the Lindner Center for Research and Education at the Christ Hospital, Cincinnati.

The registry enrolled any COVID-19–positive patient or person under investigation older than 18 years with ST-segment elevation or new-onset left bundle branch block on electrocardiogram with a clinical correlate of myocardial ischemia such as chest pain, dyspnea, cardiac arrest, shock, or mechanical ventilation. There were no exclusion criteria.

Data from 171 patients with confirmed COVID-19 and 423 PUI from 64 sites were then propensity-matched to a control population from the Midwest STEMI Consortium, a prospective, multicenter registry of consecutive STEMI patients.

The three groups were similar in sex and age but there was a striking difference in race, with 27% of African American and 24% of Hispanic patients COVID-confirmed, compared with 11% and 6% in the PUI group and 4% and 1% in the control group. Likewise, there was a significant increase in diabetes (44% vs. 33% vs. 20%), which has been reported previously with influenza.

COVID-19–positive patients, as compared with PUI and controls, were significantly more likely to present with cardiogenic shock before PCI (20% vs. 14% vs. 5%), but not cardiac arrest (12% vs. 17% vs. 11%), and to have lower left ventricular ejection fractions (45% vs. 45% vs. 50%).

They also presented with more atypical symptoms than PUI patients, particularly infiltrates on chest x-ray (49% vs. 17%) and dyspnea (58% vs. 38%). Data were not available for these outcomes among historic controls.

Importantly, 21% of the COVID-19 patients did not undergo angiography, compared with 5% of PUI patients and 0% of controls (P < .001), “which is much higher than we would expect or have suspected,” Dr. Henry said. Thrombolytic use was very uncommon in those undergoing angiography, likely as a result of the guidelines.

Very surprisingly, there were no differences in door-to-balloon times between the COVID-positive, PUI, and control groups despite the ongoing pandemic (80 min vs. 78 min vs. 86 min).

But there was clear worsening in in-hospital mortality in COVID-19–positive patients (32% vs. 12% and 6%; P < .001), as well as in-hospital stroke (3.4% vs. 2% vs. 0.6%) that reached statistical significance only when compared with historical controls (P = .039). Total length of stay was twice as long in COVID-confirmed patients as in both PUI and controls (6 days vs. 3 days; P < .001).

Following the formal presentation, invited discussant Philippe Gabriel Steg, MD, Imperial College London, said the researchers have provided a great service in reporting the data so quickly but noted that an ongoing French registry of events before, during, and after the first COVID-19 wave has not seen an increased death rate.

“Can you tease out whether the increased death rate is related to cardiovascular deaths or to COVID-related pneumonias, shocks, ARDSs [acute respiratory distress syndromes], and so on and so forth? Because our impression – and that’s what we’ve published in Lancet Public Health – is that the cardiovascular morality rate doesn’t seem that affected by COVID.”

Dr. Henry replied that these are early data but “I will tell you that patients who did get PCI had a mortality rate that was only around 12% or 13%, and the patients who did not undergo angiography or were treated with medical therapy had higher mortality. Now, of course, that’s selected and we need to do a much better matching and look at that, but that’s our goal and we will have that information,” he said.

During a press briefing on the study, discussant Renu Virmani, MD, president and founder of CVPath Institute, noted that, in their analysis of 40 autopsy cases from Bergamot, Italy, small intramyocardial microthrombi were seen in nine patients, whereas epicardial microthrombi were seen in only three or four.

“Some of the cases are being taken as being related to coronary disease but may be more thrombotic than anything else,” she said. “I think there’s a combination, and that’s why the outcomes are so poor. You didn’t show us TIMI flow but that’s something to think about: Was TIMI flow different in the patients who died because you have very high mortality? I think we need to get to the bottom of what is the underlying cause of that thrombosis.”

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

The U.S. Food and Drug Administration released new warnings Oct. 15 that most nonsteroidal anti-inflammatory agents (NSAIDs) carry an elevated risk for kidney complications in unborn children when taken around weeks 20 or later in pregnancy.

Citing newly available research, the agency states the risk of low amniotic fluid (known as oligohydramnios) can occur, which in turn can cause rare but serious kidney problems in the offspring. Pregnancy complications also can result.

The FDA action expands on earlier warnings about agents in this drug class, which the FDA previously cautioned about taking after week 30 of pregnancy because of heart-related risks.

Manufacturers of both over-the-counter and prescription NSAIDs – including ibuprofen, naproxen, diclofenac, and celecoxib – will be required to update their labeling with the new warning.

Low-dose (81-mg) aspirin is excluded from this warning.

“Low-dose aspirin may be an important treatment for some women during pregnancy and should be taken under the direction of a healthcare professional,” the agency stated in a news release.

“It is important that women understand the benefits and risks of the medications they may take over the course of their pregnancy,” Patrizia Cavazzoni, MD, acting director of FDA’s Center for Drug Evaluation and Research, states in the release. “To this end, the agency is using its regulatory authority to inform women and their healthcare providers about the risks if NSAIDs are used after around 20 weeks of pregnancy and beyond.”

Oligohydramnios can arise quickly – in as little as 2 days – or weeks after starting regular NSAID use in this patient population. The condition usually resolves if a pregnant woman stops taking the NSAID, the agency notes.

If a health care provider believes NSAIDs are necessary between about 20 and 30 weeks of pregnancy, use should be limited to the lowest effective dose and shortest duration possible, the Drug Safety Communication notes.

As a reminder, health care professionals and patients should report side effects from NSAIDs to the FDA’s MedWatch program.

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

The U.S. Food and Drug Administration released new warnings Oct. 15 that most nonsteroidal anti-inflammatory agents (NSAIDs) carry an elevated risk for kidney complications in unborn children when taken around weeks 20 or later in pregnancy.

Citing newly available research, the agency states the risk of low amniotic fluid (known as oligohydramnios) can occur, which in turn can cause rare but serious kidney problems in the offspring. Pregnancy complications also can result.

The FDA action expands on earlier warnings about agents in this drug class, which the FDA previously cautioned about taking after week 30 of pregnancy because of heart-related risks.

Manufacturers of both over-the-counter and prescription NSAIDs – including ibuprofen, naproxen, diclofenac, and celecoxib – will be required to update their labeling with the new warning.

Low-dose (81-mg) aspirin is excluded from this warning.

“Low-dose aspirin may be an important treatment for some women during pregnancy and should be taken under the direction of a healthcare professional,” the agency stated in a news release.

“It is important that women understand the benefits and risks of the medications they may take over the course of their pregnancy,” Patrizia Cavazzoni, MD, acting director of FDA’s Center for Drug Evaluation and Research, states in the release. “To this end, the agency is using its regulatory authority to inform women and their healthcare providers about the risks if NSAIDs are used after around 20 weeks of pregnancy and beyond.”

Oligohydramnios can arise quickly – in as little as 2 days – or weeks after starting regular NSAID use in this patient population. The condition usually resolves if a pregnant woman stops taking the NSAID, the agency notes.

If a health care provider believes NSAIDs are necessary between about 20 and 30 weeks of pregnancy, use should be limited to the lowest effective dose and shortest duration possible, the Drug Safety Communication notes.

As a reminder, health care professionals and patients should report side effects from NSAIDs to the FDA’s MedWatch program.

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

The U.S. Food and Drug Administration released new warnings Oct. 15 that most nonsteroidal anti-inflammatory agents (NSAIDs) carry an elevated risk for kidney complications in unborn children when taken around weeks 20 or later in pregnancy.

Citing newly available research, the agency states the risk of low amniotic fluid (known as oligohydramnios) can occur, which in turn can cause rare but serious kidney problems in the offspring. Pregnancy complications also can result.

The FDA action expands on earlier warnings about agents in this drug class, which the FDA previously cautioned about taking after week 30 of pregnancy because of heart-related risks.

Manufacturers of both over-the-counter and prescription NSAIDs – including ibuprofen, naproxen, diclofenac, and celecoxib – will be required to update their labeling with the new warning.

Low-dose (81-mg) aspirin is excluded from this warning.

“Low-dose aspirin may be an important treatment for some women during pregnancy and should be taken under the direction of a healthcare professional,” the agency stated in a news release.

“It is important that women understand the benefits and risks of the medications they may take over the course of their pregnancy,” Patrizia Cavazzoni, MD, acting director of FDA’s Center for Drug Evaluation and Research, states in the release. “To this end, the agency is using its regulatory authority to inform women and their healthcare providers about the risks if NSAIDs are used after around 20 weeks of pregnancy and beyond.”

Oligohydramnios can arise quickly – in as little as 2 days – or weeks after starting regular NSAID use in this patient population. The condition usually resolves if a pregnant woman stops taking the NSAID, the agency notes.

If a health care provider believes NSAIDs are necessary between about 20 and 30 weeks of pregnancy, use should be limited to the lowest effective dose and shortest duration possible, the Drug Safety Communication notes.

As a reminder, health care professionals and patients should report side effects from NSAIDs to the FDA’s MedWatch program.

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

As the COVID-19 pandemic continues to chug along, some communities feel it slowing to a pace at which they might feel comfortable about a return to, if not quite “business as usual,” at least “business as sort of normal-ish.” They are ready to accept a level of disease that signals they have reached a steady state. However, in other communities, the virus has picked up speed and is threatening to overwhelm the medical infrastructure. If you are in one of those fortunate and skillfully managed states in which folks are beginning to talk seriously, but with little evidence, that it is time to return to normal, it is probably far too early. Are there any metrics that could be applied to make the decision to ease restrictions more rational?

Courtesy Dr. William G. Wilkoff

Eons ago in pandemic terms, the World Health Organization in Thailand published a list of criteria to aid in determining when a community could consider lifting the limits that seemed to have been effective in halting transmission of the virus (“Transitioning to and maintaining a steady state of low-level or no transmission,” WHO, Thailand, 2020 Apr 18). While much more has been learned about the behavior of the virus since the spring of 2020, the criteria from the WHO in Thailand are worth considering.

Here is my summary of their criteria for returning to normalcy. First, virus transmission is controlled to the point that only sporadic cases and small clusters exist, and that all of these are traceable in origin. Second, health care and public health systems are in place with sufficient capacities to manage a shift from detection to treatment should the case load increase dramatically; this capacity should include detection, testing, isolation, and quarantine. Third, outbreaks in high-risk populations such as nursing homes have been minimized. Fourth, workplace prevention strategies are in place and have been demonstrated to be effective. Fifth, risk of imported cases is at manageable levels. Finally, communities are engaged.

It is hard to argue with the rationale behind each of these criteria. However, the United States is not Thailand, and just thinking about how this country would go about meeting those criteria provides a window into some of the reasons why we have done so poorly and will continue to be challenged in dealing with the pandemic.

First, notice that the criteria make no mention of a vaccine. One gets the sense that from the top down our country is banking too heavily on the effectiveness and widespread delivery of a vaccine. Even if and when a vaccine is developed and delivered, all of these criteria still must be met and kept in mind for a future pandemic.

Second, the criteria call for an effective health care system, but it is abundantly clear that the United States does not have a cohesive health care system and probably won’t for the foreseeable future. The best we can hope for is individual states cobbling together their own systems, which may in turn serve as examples for those states who haven’t had the foresight. We have had a public health system of sorts, but its credibility and effectiveness has been neutered to the point that again we must rely on each state’s ability to see through the haze and create it’s own systems for detection, testing, tracking, isolating, and quarantining – often with little help in materiel support from the federal government. The sliver of good news is that, after a bit of a stumbling start, detecting and limiting the importation of cases from abroad is being addressed.

We continue to hear and see evidence that there are segments of the population who are not engaged in the activities that we have learned are necessary to stabilize the pandemic. My sense is that those people represent a very small minority. But, it is probably large enough to make the route to a steady state on a national level long and painful. This unfortunately is to be expected in a country that was built on a framework of personal freedoms. The best you can hope for in achieving a steady state is to live in one of the states that seems to be achieving the fine balance between personal freedoms and the common good.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

As the COVID-19 pandemic continues to chug along, some communities feel it slowing to a pace at which they might feel comfortable about a return to, if not quite “business as usual,” at least “business as sort of normal-ish.” They are ready to accept a level of disease that signals they have reached a steady state. However, in other communities, the virus has picked up speed and is threatening to overwhelm the medical infrastructure. If you are in one of those fortunate and skillfully managed states in which folks are beginning to talk seriously, but with little evidence, that it is time to return to normal, it is probably far too early. Are there any metrics that could be applied to make the decision to ease restrictions more rational?

Courtesy Dr. William G. Wilkoff

Eons ago in pandemic terms, the World Health Organization in Thailand published a list of criteria to aid in determining when a community could consider lifting the limits that seemed to have been effective in halting transmission of the virus (“Transitioning to and maintaining a steady state of low-level or no transmission,” WHO, Thailand, 2020 Apr 18). While much more has been learned about the behavior of the virus since the spring of 2020, the criteria from the WHO in Thailand are worth considering.

Here is my summary of their criteria for returning to normalcy. First, virus transmission is controlled to the point that only sporadic cases and small clusters exist, and that all of these are traceable in origin. Second, health care and public health systems are in place with sufficient capacities to manage a shift from detection to treatment should the case load increase dramatically; this capacity should include detection, testing, isolation, and quarantine. Third, outbreaks in high-risk populations such as nursing homes have been minimized. Fourth, workplace prevention strategies are in place and have been demonstrated to be effective. Fifth, risk of imported cases is at manageable levels. Finally, communities are engaged.

It is hard to argue with the rationale behind each of these criteria. However, the United States is not Thailand, and just thinking about how this country would go about meeting those criteria provides a window into some of the reasons why we have done so poorly and will continue to be challenged in dealing with the pandemic.

First, notice that the criteria make no mention of a vaccine. One gets the sense that from the top down our country is banking too heavily on the effectiveness and widespread delivery of a vaccine. Even if and when a vaccine is developed and delivered, all of these criteria still must be met and kept in mind for a future pandemic.

Second, the criteria call for an effective health care system, but it is abundantly clear that the United States does not have a cohesive health care system and probably won’t for the foreseeable future. The best we can hope for is individual states cobbling together their own systems, which may in turn serve as examples for those states who haven’t had the foresight. We have had a public health system of sorts, but its credibility and effectiveness has been neutered to the point that again we must rely on each state’s ability to see through the haze and create it’s own systems for detection, testing, tracking, isolating, and quarantining – often with little help in materiel support from the federal government. The sliver of good news is that, after a bit of a stumbling start, detecting and limiting the importation of cases from abroad is being addressed.

We continue to hear and see evidence that there are segments of the population who are not engaged in the activities that we have learned are necessary to stabilize the pandemic. My sense is that those people represent a very small minority. But, it is probably large enough to make the route to a steady state on a national level long and painful. This unfortunately is to be expected in a country that was built on a framework of personal freedoms. The best you can hope for in achieving a steady state is to live in one of the states that seems to be achieving the fine balance between personal freedoms and the common good.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

As the COVID-19 pandemic continues to chug along, some communities feel it slowing to a pace at which they might feel comfortable about a return to, if not quite “business as usual,” at least “business as sort of normal-ish.” They are ready to accept a level of disease that signals they have reached a steady state. However, in other communities, the virus has picked up speed and is threatening to overwhelm the medical infrastructure. If you are in one of those fortunate and skillfully managed states in which folks are beginning to talk seriously, but with little evidence, that it is time to return to normal, it is probably far too early. Are there any metrics that could be applied to make the decision to ease restrictions more rational?

Courtesy Dr. William G. Wilkoff

Eons ago in pandemic terms, the World Health Organization in Thailand published a list of criteria to aid in determining when a community could consider lifting the limits that seemed to have been effective in halting transmission of the virus (“Transitioning to and maintaining a steady state of low-level or no transmission,” WHO, Thailand, 2020 Apr 18). While much more has been learned about the behavior of the virus since the spring of 2020, the criteria from the WHO in Thailand are worth considering.

Here is my summary of their criteria for returning to normalcy. First, virus transmission is controlled to the point that only sporadic cases and small clusters exist, and that all of these are traceable in origin. Second, health care and public health systems are in place with sufficient capacities to manage a shift from detection to treatment should the case load increase dramatically; this capacity should include detection, testing, isolation, and quarantine. Third, outbreaks in high-risk populations such as nursing homes have been minimized. Fourth, workplace prevention strategies are in place and have been demonstrated to be effective. Fifth, risk of imported cases is at manageable levels. Finally, communities are engaged.

It is hard to argue with the rationale behind each of these criteria. However, the United States is not Thailand, and just thinking about how this country would go about meeting those criteria provides a window into some of the reasons why we have done so poorly and will continue to be challenged in dealing with the pandemic.

First, notice that the criteria make no mention of a vaccine. One gets the sense that from the top down our country is banking too heavily on the effectiveness and widespread delivery of a vaccine. Even if and when a vaccine is developed and delivered, all of these criteria still must be met and kept in mind for a future pandemic.

Second, the criteria call for an effective health care system, but it is abundantly clear that the United States does not have a cohesive health care system and probably won’t for the foreseeable future. The best we can hope for is individual states cobbling together their own systems, which may in turn serve as examples for those states who haven’t had the foresight. We have had a public health system of sorts, but its credibility and effectiveness has been neutered to the point that again we must rely on each state’s ability to see through the haze and create it’s own systems for detection, testing, tracking, isolating, and quarantining – often with little help in materiel support from the federal government. The sliver of good news is that, after a bit of a stumbling start, detecting and limiting the importation of cases from abroad is being addressed.

We continue to hear and see evidence that there are segments of the population who are not engaged in the activities that we have learned are necessary to stabilize the pandemic. My sense is that those people represent a very small minority. But, it is probably large enough to make the route to a steady state on a national level long and painful. This unfortunately is to be expected in a country that was built on a framework of personal freedoms. The best you can hope for in achieving a steady state is to live in one of the states that seems to be achieving the fine balance between personal freedoms and the common good.
 

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

Masks, it seems, are effective at blocking the transmission of coronavirus. They’re also pretty good at stultifying consonants. For those specialties not accustomed to wearing a mask all day, it’s frustrating: How many times have you had to repeat yourself today? Or ask your patient to say something again? (Ain’t no one got time to repeat a third time how to do that prednisone taper). Worse, we’re losing important nonverbal cues that help us connect with our patients. How can we be understood when our faces are covered and 6 feet away?

Masks muffle both verbal and nonverbal communication. For soft-spoken or high-pitched speakers, the verbal effect is significant. In particular, masks make hearing consonants more difficult. They can make the “sh,” “th,” “f,” and “s” sounds difficult to distinguish. Typically, we’d use context and lip reading to boost the signal, but this fix is blocked (and the clear mouth-window masks are kinda creepy). 

Masks also prevent us from seeing facial microexpressions, critical information when you are trying to connect with someone or to build trust. A randomized controlled trial published in 2013 indeed showed that doctors wearing a mask were perceived as less empathetic and had diminished relational continuity with patients as compared to doctors not wearing a mask. There are a few things we can do to help. 

Speak more loudly is obvious advice. Loud talking has limitations though, as it can feel rude, and it blunts inflections, which add richness and emotion. (Shouting “THIS WILL ONLY HURT A LITTLE” seems a mixed message). More important than the volume is your choice of words. Try to use simple terms and short sentences. Pause between points. Hit your consonants harder. 

It’s also important that you have their full attention and are giving yours. As much as possible, try to align squared up with patients. Facing your computer exacerbates the problem. Look them in their eyes and be sure they are connected with you before any complex or difficult conversations. Hearing-impaired patients are now sometimes leaving out their aids because it’s too uncomfortable to wear them with their mask. You might ask them to put them back in. Check in with patients and repeat back what you heard them say. This can help with clarity and with connecting. Use your face more: if you’ve ever acted on stage, this would be your on-stage face. Exaggerate your expressions so it’s a little easier for them to read you. 

Lastly, there are apps such as Ava or Google Live Translator, which can transcribe your speech real time. You could then share your screen with the patient so they can read exactly what you’ve said. 

Some of us are natural communicators. Even if you are not, you can mitigate some of our current challenges. I’ll admit, it’s been a bit easier for me than for others. Between my prominent eyebrows and Italian-American upbringing, I can express my way through pretty much any face covering.  If you’d like to learn how to use your hands better, then just watch this little girl: https://youtu.be/Z5wAWyqDrnc.

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected].

Masks, it seems, are effective at blocking the transmission of coronavirus. They’re also pretty good at stultifying consonants. For those specialties not accustomed to wearing a mask all day, it’s frustrating: How many times have you had to repeat yourself today? Or ask your patient to say something again? (Ain’t no one got time to repeat a third time how to do that prednisone taper). Worse, we’re losing important nonverbal cues that help us connect with our patients. How can we be understood when our faces are covered and 6 feet away?

Masks muffle both verbal and nonverbal communication. For soft-spoken or high-pitched speakers, the verbal effect is significant. In particular, masks make hearing consonants more difficult. They can make the “sh,” “th,” “f,” and “s” sounds difficult to distinguish. Typically, we’d use context and lip reading to boost the signal, but this fix is blocked (and the clear mouth-window masks are kinda creepy). 

Masks also prevent us from seeing facial microexpressions, critical information when you are trying to connect with someone or to build trust. A randomized controlled trial published in 2013 indeed showed that doctors wearing a mask were perceived as less empathetic and had diminished relational continuity with patients as compared to doctors not wearing a mask. There are a few things we can do to help. 

Speak more loudly is obvious advice. Loud talking has limitations though, as it can feel rude, and it blunts inflections, which add richness and emotion. (Shouting “THIS WILL ONLY HURT A LITTLE” seems a mixed message). More important than the volume is your choice of words. Try to use simple terms and short sentences. Pause between points. Hit your consonants harder. 

It’s also important that you have their full attention and are giving yours. As much as possible, try to align squared up with patients. Facing your computer exacerbates the problem. Look them in their eyes and be sure they are connected with you before any complex or difficult conversations. Hearing-impaired patients are now sometimes leaving out their aids because it’s too uncomfortable to wear them with their mask. You might ask them to put them back in. Check in with patients and repeat back what you heard them say. This can help with clarity and with connecting. Use your face more: if you’ve ever acted on stage, this would be your on-stage face. Exaggerate your expressions so it’s a little easier for them to read you. 

Lastly, there are apps such as Ava or Google Live Translator, which can transcribe your speech real time. You could then share your screen with the patient so they can read exactly what you’ve said. 

Some of us are natural communicators. Even if you are not, you can mitigate some of our current challenges. I’ll admit, it’s been a bit easier for me than for others. Between my prominent eyebrows and Italian-American upbringing, I can express my way through pretty much any face covering.  If you’d like to learn how to use your hands better, then just watch this little girl: https://youtu.be/Z5wAWyqDrnc.

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected].

Masks, it seems, are effective at blocking the transmission of coronavirus. They’re also pretty good at stultifying consonants. For those specialties not accustomed to wearing a mask all day, it’s frustrating: How many times have you had to repeat yourself today? Or ask your patient to say something again? (Ain’t no one got time to repeat a third time how to do that prednisone taper). Worse, we’re losing important nonverbal cues that help us connect with our patients. How can we be understood when our faces are covered and 6 feet away?

Masks muffle both verbal and nonverbal communication. For soft-spoken or high-pitched speakers, the verbal effect is significant. In particular, masks make hearing consonants more difficult. They can make the “sh,” “th,” “f,” and “s” sounds difficult to distinguish. Typically, we’d use context and lip reading to boost the signal, but this fix is blocked (and the clear mouth-window masks are kinda creepy). 

Masks also prevent us from seeing facial microexpressions, critical information when you are trying to connect with someone or to build trust. A randomized controlled trial published in 2013 indeed showed that doctors wearing a mask were perceived as less empathetic and had diminished relational continuity with patients as compared to doctors not wearing a mask. There are a few things we can do to help. 

Speak more loudly is obvious advice. Loud talking has limitations though, as it can feel rude, and it blunts inflections, which add richness and emotion. (Shouting “THIS WILL ONLY HURT A LITTLE” seems a mixed message). More important than the volume is your choice of words. Try to use simple terms and short sentences. Pause between points. Hit your consonants harder. 

It’s also important that you have their full attention and are giving yours. As much as possible, try to align squared up with patients. Facing your computer exacerbates the problem. Look them in their eyes and be sure they are connected with you before any complex or difficult conversations. Hearing-impaired patients are now sometimes leaving out their aids because it’s too uncomfortable to wear them with their mask. You might ask them to put them back in. Check in with patients and repeat back what you heard them say. This can help with clarity and with connecting. Use your face more: if you’ve ever acted on stage, this would be your on-stage face. Exaggerate your expressions so it’s a little easier for them to read you. 

Lastly, there are apps such as Ava or Google Live Translator, which can transcribe your speech real time. You could then share your screen with the patient so they can read exactly what you’ve said. 

Some of us are natural communicators. Even if you are not, you can mitigate some of our current challenges. I’ll admit, it’s been a bit easier for me than for others. Between my prominent eyebrows and Italian-American upbringing, I can express my way through pretty much any face covering.  If you’d like to learn how to use your hands better, then just watch this little girl: https://youtu.be/Z5wAWyqDrnc.

Dr. Benabio is director of Healthcare Transformation and chief of dermatology at Kaiser Permanente San Diego. The opinions expressed in this column are his own and do not represent those of Kaiser Permanente. Dr. Benabio is @Dermdoc on Twitter. Write to him at [email protected].

Blood group O was associated with a decreased risk for contracting SARS-CoV-2 infection, according to the results of large retrospective analysis of the Danish population.

Researchers Mike Bogetofte Barnkob, MD, of the Department of Clinical Immunology, Odense (Denmark) University Hospital, and colleagues performed a retrospective cohort analysis of all Danish individuals with a known ABO blood group who were tested for SARS-CoV-2 between Feb. 27, 2020, and July 30, 2020.

Of the 841,327 people tested, ABO and RhD blood groups could be identified for 473,654 individuals. ABO and RhD data from 2,204,742 (38% of the entire Danish population) were used as a reference, according to the online report in Blood Advances.

The primary outcome was status of ABO and RhD blood groups and test results for SARS-CoV-2. The secondary outcomes followed were hospitalization and death from COVID-19.
 

Reduced prevalence

The study found that ABO blood groups varied significantly between patients and the reference group, with only 38.41% (95% confidence interval, 37.30%-39.50%) of the patients belonging to blood group O, compared with 41.70% (95% CI, 41.60%-41.80%) in the controls, corresponding to a relative risk of 0.87 (95% CI, 0.83-0.91) for acquiring COVID-19.

There was a slight, but statistically significant, difference in blood group distribution between the SARS-CoV-22 individuals and the reference population (P < .001), according to the authors.

Among the SARS-CoV-2 individuals, fewer group O individuals were found (P < .001); while more A, B, and AB individuals were seen (P < .001, P = .011, and P = .091, respectively). There was no significant difference seen among A, B, and AB blood groups (P = .30). The RR for contracting SARS-CoV-2 were 1.09 (95% CI, 1.04-1.14) for A group individuals; 1.06 (95% CI, 0.99-1.14) for B group; and 1.15 (95% CI, 1.03-1.27) for AB group, respectively.

There was no difference found in the RhD group between positive test cases and the reference population (P = .15). In addition, there was no statistical difference (all P > .40) between ABO blood groups and clinical severity of COVID-19 for nonhospitalized patients versus hospitalized patients or for deceased patients versus living patients, the researchers added.
 

Possible causes

The authors speculated on two possible causes of the lower prevalence of SARS-CoV-2 infection in the blood group O population. The first is that anti-A and anti-B antibodies may have an effect on neutralizing SARS-CoV viruses and that anti-A and anti-B are present on mucosal surfaces in some individuals lacking the corresponding ABO blood group. The second is that the association between ABO blood groups and levels of von Willebrand factor, which is higher in non-O individuals and is tied to an increased likelihood of arterial and venous thrombosis, could have an indirect or unknown impact on susceptibility to infection, according to the authors.

“Given the known increased risk of thrombosis in non-O individuals and the evolving central role for thrombosis in the pathogenesis of COVID-19, it is important to explore this aspect more closely in larger patient cohorts (e.g., by examining ABO blood type and viral load, the severity of symptoms, and the long-term effects following COVID-19),” the researchers concluded.

One author reported receiving fees from Bristol Myers Squibb, Novartis, and Roche. The remaining authors reported they had no competing financial interests.

[email protected]

SOURCE: Barnkob MB et al. Blood Adv. 2020 Oct 14. doi: 10.1182/bloodadvances.2020002657.

Blood group O was associated with a decreased risk for contracting SARS-CoV-2 infection, according to the results of large retrospective analysis of the Danish population.

Researchers Mike Bogetofte Barnkob, MD, of the Department of Clinical Immunology, Odense (Denmark) University Hospital, and colleagues performed a retrospective cohort analysis of all Danish individuals with a known ABO blood group who were tested for SARS-CoV-2 between Feb. 27, 2020, and July 30, 2020.

Of the 841,327 people tested, ABO and RhD blood groups could be identified for 473,654 individuals. ABO and RhD data from 2,204,742 (38% of the entire Danish population) were used as a reference, according to the online report in Blood Advances.

The primary outcome was status of ABO and RhD blood groups and test results for SARS-CoV-2. The secondary outcomes followed were hospitalization and death from COVID-19.
 

Reduced prevalence

The study found that ABO blood groups varied significantly between patients and the reference group, with only 38.41% (95% confidence interval, 37.30%-39.50%) of the patients belonging to blood group O, compared with 41.70% (95% CI, 41.60%-41.80%) in the controls, corresponding to a relative risk of 0.87 (95% CI, 0.83-0.91) for acquiring COVID-19.

There was a slight, but statistically significant, difference in blood group distribution between the SARS-CoV-22 individuals and the reference population (P < .001), according to the authors.

Among the SARS-CoV-2 individuals, fewer group O individuals were found (P < .001); while more A, B, and AB individuals were seen (P < .001, P = .011, and P = .091, respectively). There was no significant difference seen among A, B, and AB blood groups (P = .30). The RR for contracting SARS-CoV-2 were 1.09 (95% CI, 1.04-1.14) for A group individuals; 1.06 (95% CI, 0.99-1.14) for B group; and 1.15 (95% CI, 1.03-1.27) for AB group, respectively.

There was no difference found in the RhD group between positive test cases and the reference population (P = .15). In addition, there was no statistical difference (all P > .40) between ABO blood groups and clinical severity of COVID-19 for nonhospitalized patients versus hospitalized patients or for deceased patients versus living patients, the researchers added.
 

Possible causes

The authors speculated on two possible causes of the lower prevalence of SARS-CoV-2 infection in the blood group O population. The first is that anti-A and anti-B antibodies may have an effect on neutralizing SARS-CoV viruses and that anti-A and anti-B are present on mucosal surfaces in some individuals lacking the corresponding ABO blood group. The second is that the association between ABO blood groups and levels of von Willebrand factor, which is higher in non-O individuals and is tied to an increased likelihood of arterial and venous thrombosis, could have an indirect or unknown impact on susceptibility to infection, according to the authors.

“Given the known increased risk of thrombosis in non-O individuals and the evolving central role for thrombosis in the pathogenesis of COVID-19, it is important to explore this aspect more closely in larger patient cohorts (e.g., by examining ABO blood type and viral load, the severity of symptoms, and the long-term effects following COVID-19),” the researchers concluded.

One author reported receiving fees from Bristol Myers Squibb, Novartis, and Roche. The remaining authors reported they had no competing financial interests.

[email protected]

SOURCE: Barnkob MB et al. Blood Adv. 2020 Oct 14. doi: 10.1182/bloodadvances.2020002657.

Blood group O was associated with a decreased risk for contracting SARS-CoV-2 infection, according to the results of large retrospective analysis of the Danish population.

Researchers Mike Bogetofte Barnkob, MD, of the Department of Clinical Immunology, Odense (Denmark) University Hospital, and colleagues performed a retrospective cohort analysis of all Danish individuals with a known ABO blood group who were tested for SARS-CoV-2 between Feb. 27, 2020, and July 30, 2020.

Of the 841,327 people tested, ABO and RhD blood groups could be identified for 473,654 individuals. ABO and RhD data from 2,204,742 (38% of the entire Danish population) were used as a reference, according to the online report in Blood Advances.

The primary outcome was status of ABO and RhD blood groups and test results for SARS-CoV-2. The secondary outcomes followed were hospitalization and death from COVID-19.
 

Reduced prevalence

The study found that ABO blood groups varied significantly between patients and the reference group, with only 38.41% (95% confidence interval, 37.30%-39.50%) of the patients belonging to blood group O, compared with 41.70% (95% CI, 41.60%-41.80%) in the controls, corresponding to a relative risk of 0.87 (95% CI, 0.83-0.91) for acquiring COVID-19.

There was a slight, but statistically significant, difference in blood group distribution between the SARS-CoV-22 individuals and the reference population (P < .001), according to the authors.

Among the SARS-CoV-2 individuals, fewer group O individuals were found (P < .001); while more A, B, and AB individuals were seen (P < .001, P = .011, and P = .091, respectively). There was no significant difference seen among A, B, and AB blood groups (P = .30). The RR for contracting SARS-CoV-2 were 1.09 (95% CI, 1.04-1.14) for A group individuals; 1.06 (95% CI, 0.99-1.14) for B group; and 1.15 (95% CI, 1.03-1.27) for AB group, respectively.

There was no difference found in the RhD group between positive test cases and the reference population (P = .15). In addition, there was no statistical difference (all P > .40) between ABO blood groups and clinical severity of COVID-19 for nonhospitalized patients versus hospitalized patients or for deceased patients versus living patients, the researchers added.
 

Possible causes

The authors speculated on two possible causes of the lower prevalence of SARS-CoV-2 infection in the blood group O population. The first is that anti-A and anti-B antibodies may have an effect on neutralizing SARS-CoV viruses and that anti-A and anti-B are present on mucosal surfaces in some individuals lacking the corresponding ABO blood group. The second is that the association between ABO blood groups and levels of von Willebrand factor, which is higher in non-O individuals and is tied to an increased likelihood of arterial and venous thrombosis, could have an indirect or unknown impact on susceptibility to infection, according to the authors.

“Given the known increased risk of thrombosis in non-O individuals and the evolving central role for thrombosis in the pathogenesis of COVID-19, it is important to explore this aspect more closely in larger patient cohorts (e.g., by examining ABO blood type and viral load, the severity of symptoms, and the long-term effects following COVID-19),” the researchers concluded.

One author reported receiving fees from Bristol Myers Squibb, Novartis, and Roche. The remaining authors reported they had no competing financial interests.

[email protected]

SOURCE: Barnkob MB et al. Blood Adv. 2020 Oct 14. doi: 10.1182/bloodadvances.2020002657.

Treatment-naive HIV patients had similar rates of treatment failure and virologic failure on standard triple therapy and a variety of dual therapy regimens, based on a meta-analysis including data from more than 5,000 patients.

Although triple therapy remains the standard of care, the availability of more potent drugs has revived interest in dual and mono therapies, wrote Pisaturo Mariantonietta, MD, of the University of Campania Luigi Vanvitelli, Naples, Italy, and colleagues.

In a study published in Clinical Microbiology and Infection, the researchers identified 14 articles including 5,205 treatment-naive HIV adults. The studies were published between 2008 and 2020; 13 were randomized, controlled trials.

The dual therapies used in the studies included atazanavir/r plus maraviroc; lopinavir/r plus lamivudine; raltegravir plus darunavir/r; lopinavir/r plus tenofovir, raltegravir, efavirenz, or maraviroc; atazanavir/r plus raltegravir and darunavir/r plus maraviroc; and dolutegravir plus lamivudine.

Overall, no significant differences occurred in the primary endpoint of treatment failure across 10 studies between dual therapy and triple therapy patients based on data at 48 weeks (relative risk 1.20). “The rate of treatment failure did not differ among the two groups when stratifying the patients according to the drug used in the dual regimen,” the researchers said.

Low viral load’s link to treatment failure

Among 2,398 patients with a low HIV viral load (less than 100,000 copies/mL), dual therapy patients were significantly more likely to experience treatment failure than were triple therapy patients (RR, 1.47, P = .007). No differences were noted between dual and triple therapy failure among patients with high HIV viral loads at baseline. Patterns were similar at 96 weeks, but only three studies included 96-week data, the researchers said.

The rate of discontinuation because of adverse events was not significantly different between the groups at 48 weeks.

The study findings were limited by several factors, including the use of different regimens in the dual strategies, some of which are no longer in use, as well as there being insufficient data to fully compare outcomes at 96 weeks, and lack of information on cerebrospinal fluid viral load, the researchers noted.

However, the results suggest that dual therapy might be considered for HIV-naive patients with a low viral load, they said.

“Further RCTs that will evaluate the efficacy of antiretroviral regimens in use today among difficult-to-treat populations, such as patients with high viral load, including both intention-to-treat and per-protocol analysis, are needed to address this topic,” they concluded.

Consider range of patient factors when choosing therapies

Conducting the study at this time was important because of the expanding options for treating HIV patients, Donna E. Sweet, MD, an HIV specialist and professor of medicine at the University of Kansas, Wichita, said in an interview.

“We now have two single tablet formulations that are dual rather than triple therapy, and as treaters we are all trying to know when to use them,” she explained.

Dr. Sweet said she was not surprised by the study findings, given that well-conducted, randomized, controlled trials allowed the combination therapies to be approved.

Some of the key challenges to identifying the optimal treatment for HIV patients include factoring in the use of concomitant medications that could lead to drug-drug interactions, noted Dr. Sweet, who serves an editorial advisory board member of Internal Medicine News.

The take-home message for clinicians, in her opinion, is that “less drugs may mean less toxicity, but we don’t want to sacrifice efficacy,” she said. “There may be patients who are better suited than others for two vs. three drugs,” Dr. Sweet emphasized.

The next steps for research on the value of dual vs. triple therapy should include longer term efficacy studies, especially in those with lower CD4 counts and higher viral loads, said Dr. Sweet. In addition to factors such as CD4 counts and viral load, the food requirements of certain ART regimens could affect adherence and therefore a clinician decision to use two drugs rather than three, she noted.

Dr. Sweet disclosed past relationships with ViiV, Gilead, Merck, and Janssen on their speakers bureaus, and current advisory roles with Gilead and ViiV.

The study received no outside funding. Lead author Dr. Mariantonietta and several coauthors disclosed relationships with companies including ViiV Healthcare, AbbVie, Janssen-Cilag and Gilead Science, and Merck Sharp & Dohme, but no conflicts in connection with this study.

SOURCE: Mariantonietta P et al. Clin Microbiol Infect. 2020 Oct 5. doi: 10.1016/j.cmi.2020.09.048.

Treatment-naive HIV patients had similar rates of treatment failure and virologic failure on standard triple therapy and a variety of dual therapy regimens, based on a meta-analysis including data from more than 5,000 patients.

Although triple therapy remains the standard of care, the availability of more potent drugs has revived interest in dual and mono therapies, wrote Pisaturo Mariantonietta, MD, of the University of Campania Luigi Vanvitelli, Naples, Italy, and colleagues.

In a study published in Clinical Microbiology and Infection, the researchers identified 14 articles including 5,205 treatment-naive HIV adults. The studies were published between 2008 and 2020; 13 were randomized, controlled trials.

The dual therapies used in the studies included atazanavir/r plus maraviroc; lopinavir/r plus lamivudine; raltegravir plus darunavir/r; lopinavir/r plus tenofovir, raltegravir, efavirenz, or maraviroc; atazanavir/r plus raltegravir and darunavir/r plus maraviroc; and dolutegravir plus lamivudine.

Overall, no significant differences occurred in the primary endpoint of treatment failure across 10 studies between dual therapy and triple therapy patients based on data at 48 weeks (relative risk 1.20). “The rate of treatment failure did not differ among the two groups when stratifying the patients according to the drug used in the dual regimen,” the researchers said.

Low viral load’s link to treatment failure

Among 2,398 patients with a low HIV viral load (less than 100,000 copies/mL), dual therapy patients were significantly more likely to experience treatment failure than were triple therapy patients (RR, 1.47, P = .007). No differences were noted between dual and triple therapy failure among patients with high HIV viral loads at baseline. Patterns were similar at 96 weeks, but only three studies included 96-week data, the researchers said.

The rate of discontinuation because of adverse events was not significantly different between the groups at 48 weeks.

The study findings were limited by several factors, including the use of different regimens in the dual strategies, some of which are no longer in use, as well as there being insufficient data to fully compare outcomes at 96 weeks, and lack of information on cerebrospinal fluid viral load, the researchers noted.

However, the results suggest that dual therapy might be considered for HIV-naive patients with a low viral load, they said.

“Further RCTs that will evaluate the efficacy of antiretroviral regimens in use today among difficult-to-treat populations, such as patients with high viral load, including both intention-to-treat and per-protocol analysis, are needed to address this topic,” they concluded.

Consider range of patient factors when choosing therapies

Conducting the study at this time was important because of the expanding options for treating HIV patients, Donna E. Sweet, MD, an HIV specialist and professor of medicine at the University of Kansas, Wichita, said in an interview.

“We now have two single tablet formulations that are dual rather than triple therapy, and as treaters we are all trying to know when to use them,” she explained.

Dr. Sweet said she was not surprised by the study findings, given that well-conducted, randomized, controlled trials allowed the combination therapies to be approved.

Some of the key challenges to identifying the optimal treatment for HIV patients include factoring in the use of concomitant medications that could lead to drug-drug interactions, noted Dr. Sweet, who serves an editorial advisory board member of Internal Medicine News.

The take-home message for clinicians, in her opinion, is that “less drugs may mean less toxicity, but we don’t want to sacrifice efficacy,” she said. “There may be patients who are better suited than others for two vs. three drugs,” Dr. Sweet emphasized.

The next steps for research on the value of dual vs. triple therapy should include longer term efficacy studies, especially in those with lower CD4 counts and higher viral loads, said Dr. Sweet. In addition to factors such as CD4 counts and viral load, the food requirements of certain ART regimens could affect adherence and therefore a clinician decision to use two drugs rather than three, she noted.

Dr. Sweet disclosed past relationships with ViiV, Gilead, Merck, and Janssen on their speakers bureaus, and current advisory roles with Gilead and ViiV.

The study received no outside funding. Lead author Dr. Mariantonietta and several coauthors disclosed relationships with companies including ViiV Healthcare, AbbVie, Janssen-Cilag and Gilead Science, and Merck Sharp & Dohme, but no conflicts in connection with this study.

SOURCE: Mariantonietta P et al. Clin Microbiol Infect. 2020 Oct 5. doi: 10.1016/j.cmi.2020.09.048.

Treatment-naive HIV patients had similar rates of treatment failure and virologic failure on standard triple therapy and a variety of dual therapy regimens, based on a meta-analysis including data from more than 5,000 patients.

Although triple therapy remains the standard of care, the availability of more potent drugs has revived interest in dual and mono therapies, wrote Pisaturo Mariantonietta, MD, of the University of Campania Luigi Vanvitelli, Naples, Italy, and colleagues.

In a study published in Clinical Microbiology and Infection, the researchers identified 14 articles including 5,205 treatment-naive HIV adults. The studies were published between 2008 and 2020; 13 were randomized, controlled trials.

The dual therapies used in the studies included atazanavir/r plus maraviroc; lopinavir/r plus lamivudine; raltegravir plus darunavir/r; lopinavir/r plus tenofovir, raltegravir, efavirenz, or maraviroc; atazanavir/r plus raltegravir and darunavir/r plus maraviroc; and dolutegravir plus lamivudine.

Overall, no significant differences occurred in the primary endpoint of treatment failure across 10 studies between dual therapy and triple therapy patients based on data at 48 weeks (relative risk 1.20). “The rate of treatment failure did not differ among the two groups when stratifying the patients according to the drug used in the dual regimen,” the researchers said.

Low viral load’s link to treatment failure

Among 2,398 patients with a low HIV viral load (less than 100,000 copies/mL), dual therapy patients were significantly more likely to experience treatment failure than were triple therapy patients (RR, 1.47, P = .007). No differences were noted between dual and triple therapy failure among patients with high HIV viral loads at baseline. Patterns were similar at 96 weeks, but only three studies included 96-week data, the researchers said.

The rate of discontinuation because of adverse events was not significantly different between the groups at 48 weeks.

The study findings were limited by several factors, including the use of different regimens in the dual strategies, some of which are no longer in use, as well as there being insufficient data to fully compare outcomes at 96 weeks, and lack of information on cerebrospinal fluid viral load, the researchers noted.

However, the results suggest that dual therapy might be considered for HIV-naive patients with a low viral load, they said.

“Further RCTs that will evaluate the efficacy of antiretroviral regimens in use today among difficult-to-treat populations, such as patients with high viral load, including both intention-to-treat and per-protocol analysis, are needed to address this topic,” they concluded.

Consider range of patient factors when choosing therapies

Conducting the study at this time was important because of the expanding options for treating HIV patients, Donna E. Sweet, MD, an HIV specialist and professor of medicine at the University of Kansas, Wichita, said in an interview.

“We now have two single tablet formulations that are dual rather than triple therapy, and as treaters we are all trying to know when to use them,” she explained.

Dr. Sweet said she was not surprised by the study findings, given that well-conducted, randomized, controlled trials allowed the combination therapies to be approved.

Some of the key challenges to identifying the optimal treatment for HIV patients include factoring in the use of concomitant medications that could lead to drug-drug interactions, noted Dr. Sweet, who serves an editorial advisory board member of Internal Medicine News.

The take-home message for clinicians, in her opinion, is that “less drugs may mean less toxicity, but we don’t want to sacrifice efficacy,” she said. “There may be patients who are better suited than others for two vs. three drugs,” Dr. Sweet emphasized.

The next steps for research on the value of dual vs. triple therapy should include longer term efficacy studies, especially in those with lower CD4 counts and higher viral loads, said Dr. Sweet. In addition to factors such as CD4 counts and viral load, the food requirements of certain ART regimens could affect adherence and therefore a clinician decision to use two drugs rather than three, she noted.

Dr. Sweet disclosed past relationships with ViiV, Gilead, Merck, and Janssen on their speakers bureaus, and current advisory roles with Gilead and ViiV.

The study received no outside funding. Lead author Dr. Mariantonietta and several coauthors disclosed relationships with companies including ViiV Healthcare, AbbVie, Janssen-Cilag and Gilead Science, and Merck Sharp & Dohme, but no conflicts in connection with this study.

SOURCE: Mariantonietta P et al. Clin Microbiol Infect. 2020 Oct 5. doi: 10.1016/j.cmi.2020.09.048.

Medicare officials must soon decide whether to kick off next year with a shift of money away from specialties centered around procedures and toward primary care and other fields more focused on office visits.

A planned overhaul of reimbursement for evaluation and management (E/M) services emerged as perhaps the most contentious issue connected to Medicare’s 2021 payment policies for clinicians.

roobcio/Thinkstock

The Centers for Medicare & Medicaid Services (CMS) included the planned E/M overhaul — and accompanying offsets — in the draft 2021 physician fee schedule, released in August. The draft fee schedule drew at least 45,675 responses by October 5, the deadline for offering comments, with many of the responses addressing the E/M overhaul.

The influential Medicare Payment Advisory Commission (MedPAC) “strongly” endorsed the “budget-neutral” approach taken with the E/M overhaul. This planned reshuffling of payments is a step toward addressing a shortfall of primary care clinicians, inasmuch as it would help make this field more financially appealing, MedPAC said in an October 2 letter to CMS.

In contrast, physician organizations, including the American Medical Association (AMA), asked CMS to waive or revise the budget-neutral aspect of the E/M overhaul. Among the specialties slated for reductions are those deeply involved with the response to the pandemic, wrote James L. Madara, AMA’s chief executive officer, in an October 5 comment to CMS. Emergency medicine as a field would see a 6% cut, and infectious disease specialists, a 4% reduction.

“Payment reductions of this magnitude would be a major problem at any time, but to impose cuts of this magnitude during or immediately after the COVID-19 pandemic, including steep cuts to many of the specialties that have been on the front lines in efforts to treat patients in places with widespread infection, is unconscionable,” Madara wrote.

Madara also said specialties scheduled for payment reductions include those least able to make up for the lack of in-person care as a result of the uptick in telehealth during the pandemic.

A chart in the draft physician fee schedule (Table 90) shows reductions for many specialties that do not routinely bill for office visits. The table shows an 8% cut for anesthesiologists, a 7% cut for general surgeons, and a 6% cut for ophthalmologists. Table 90 also shows an estimated 11% reduction for radiologists and a 9% drop for pathologists.

The draft rule notes that these figures are based upon estimates of aggregate allowed charges across all services, so they may not reflect what any particular clinician might receive.

In total, Table 90 shows how the E/M changes and connected offsets would affect more than 50 fields of medicine. The proposal includes a 17% expected increase for endocrinologists and a 14% bump for those in hematology/oncology. There are expected increases of 13% for family practice and 4% for internal medicine.

This reshuffling of payments among specialties is only part of the 2021 E/M overhaul. There’s strong support for other aspects, making it unlikely that CMS would consider dropping the plan entirely.

“CMS’ new office visit policy will lead to significant administrative burden reduction and will better describe and recognize the resources involved in clinical office visits as they are performed today,” AMA’s Madara wrote in his comment.

Changes for the billing framework for E/M slated to start in 2021 are the result of substantial collaboration by an AMA-convened work group, which brought together more than 170 state medical and specialty societies, Madara said in his comment.

CMS has been developing this plan for several years. It outlined this 2021 E/M overhaul in the 2020 Medicare physician fee schedule finalized last year.

Madara urged CMS to proceed with the E/M changes but also “exercise the full breadth and depth of its administrative authority” to avoid or minimize the planned cuts.

“To be clear, we are not asking CMS to phase in implementation of the E/M changes but rather to phase in the payment reductions for certain specialties and health professionals in 2021 due to budget neutrality,” he wrote.

Other groups asking CMS to waive the budget-neutrality requirement include the American College of Physicians, the American College of Emergency Physicians, the American Society for Radiation Oncology, and the American Society of Neuroradiology.

The American Academy of Family Physicians (AAFP) asked CMS to temporarily waive the budget-neutrality requirement and pressed the agency to maintain the underlying principle of the E/M overhaul.

“Should HHS [Department of Health and Human Services] use its authority to waive budget neutrality, we also recommend that CMS finalize a reinstatement plan for the conversion factor reductions that provides physician practices with ample time to prepare and does not result in a financial cliff,” wrote John S. Cullen, MD, board chair for AAFP, in a September 28 comment to CMS.

Owing to the declaration of a public health emergency, HHS could use a special provision known as 1135 waiver authority to waive budget-neutrality requirements, Cullen wrote.

“The AAFP understands that HHS’ authority is limited by the timing of the end of the public health emergency, but we believe that this approach will provide Congress with needed time to enact an accompanying legislative solution,” he wrote.
 

Lawmakers weigh in

Lawmakers in both political parties have asked CMS to reconsider the offsets in the E/M overhaul.

Rep. Michael C. Burgess, MD (R-TX), who practiced as an obstetrician before joining Congress, in October introduced a bill with Rep. Bobby Rush (D-IL) that would provide for a 1-year waiver of budget-neutrality adjustments under the Medicare physician fee schedule.

Burgess and Rush were among the more than 160 members of Congress who signed a September letter to CMS asking the agency to act on its own to drop the budget-neutrality requirement. In the letter, led by Rep. Roger Marshall, MD (R-KS), the lawmakers acknowledge the usual legal requirements for CMS to offset payment increases in the physician fee schedule with cuts. But the lawmakers said the national public health emergency allows CMS to work around this.

“Given the effects of the COVID-19 pandemic, we believe you have the regulatory authority to immediately address these inequities,” the lawmakers wrote. “There is also the need to consider how the outbreak will be in the fall/winter months and if postponing certain elective procedures will go back into effect, per CMS’ recommendations.

“While we understand that legislative action may also be required to address this issue, given the January 1, 2021 effective date, we would ask you to take immediate actions to delay or mitigate these cuts while allowing the scheduled increases to go into effect,” the lawmakers said in closing their letter. “This approach will give Congress sufficient time to develop a meaningful solution and to address these looming needs.”

Another option might be for CMS to preserve the budget-neutrality claim for the 2021 physician fee schedule but soften the blow on specialties, Brian Fortune, president of the consulting firm Farragut Square Group, told Medscape Medical News. A former staffer for Republican leadership in the House of Representatives, Fortune has for more than 20 years followed Medicare policy.

The agency could redo some of the assumptions used in estimating the offsets, he said, adding that in the draft rule, CMS appears to be seeking feedback that could help it with new calculations.

“CMS has been looking for a way out,” Fortune said. “CMS could remodel the assumptions, and the cuts could drop by half or more.

“The agency has several options to get creative as the need arises,” he said.

“Overvalued” vs “devalued”

In its comment to CMS, though, MedPAC argued strongly for maintaining the offsets. The commission has for several years been investigating ways to use Medicare’s payment policies as a tool to boost the ranks of clinicians who provide primary care.

A reshuffling of payments among specialties is needed to address a known imbalance in which Medicare for many years has “overvalued” procedures at the expense of other medical care, wrote Michael E. Chernew, PhD, the chairman of MedPAC, in an October 2 comment to CMS.

“Some types of services — such as procedures, imaging, and tests — experience efficiency gains over time, as advances in technology, technique, and clinical practice enable clinicians to deliver them faster,” he wrote. “However, E&M office/outpatient visits do not lend themselves to such efficiency gains because they consist largely of activities that require the clinician’s time.”

Medicare’s payment policies have thus “passively devalued” the time many clinicians spend on office visits, helping to skew the decisions of young physicians toward specialties, according to Chernew.

Reshuffling payment away from specialties that are now “overvalued” is needed to “remedy several years of passive devaluation,” he wrote.

The median income in 2018 for primary care physicians was $243,000 in 2018, whereas that of specialists such as surgeons was $426,000, Chernew said in the letter, citing MedPAC research.

These figures echo the findings of Medscape’s most recent annual physician compensation report.

As one of the largest buyers of medical services, Medicare has significant influence on the practice of medicine in the United States. In 2018 alone, Medicare directly paid $70.5 billion for clinician services. Its payment policies already may have shaped the pool of clinicians available to treat people enrolled in Medicare, which covers those aged 65 years and older, Chernew said.

“The US has over three times as many specialists as primary care physicians, which could explain why MedPAC’s annual survey of Medicare beneficiaries has repeatedly found that beneficiaries who are looking for a new physician report having an easier time finding a new specialist than a new primary care provider,” he wrote.

“Access to primary care physicians could worsen in the future as the number of primary care physicians in the US, after remaining flat for several years, has actually started to decline,” Chernew said.

This article first appeared on Medscape.com.

Medicare officials must soon decide whether to kick off next year with a shift of money away from specialties centered around procedures and toward primary care and other fields more focused on office visits.

A planned overhaul of reimbursement for evaluation and management (E/M) services emerged as perhaps the most contentious issue connected to Medicare’s 2021 payment policies for clinicians.

roobcio/Thinkstock

The Centers for Medicare & Medicaid Services (CMS) included the planned E/M overhaul — and accompanying offsets — in the draft 2021 physician fee schedule, released in August. The draft fee schedule drew at least 45,675 responses by October 5, the deadline for offering comments, with many of the responses addressing the E/M overhaul.

The influential Medicare Payment Advisory Commission (MedPAC) “strongly” endorsed the “budget-neutral” approach taken with the E/M overhaul. This planned reshuffling of payments is a step toward addressing a shortfall of primary care clinicians, inasmuch as it would help make this field more financially appealing, MedPAC said in an October 2 letter to CMS.

In contrast, physician organizations, including the American Medical Association (AMA), asked CMS to waive or revise the budget-neutral aspect of the E/M overhaul. Among the specialties slated for reductions are those deeply involved with the response to the pandemic, wrote James L. Madara, AMA’s chief executive officer, in an October 5 comment to CMS. Emergency medicine as a field would see a 6% cut, and infectious disease specialists, a 4% reduction.

“Payment reductions of this magnitude would be a major problem at any time, but to impose cuts of this magnitude during or immediately after the COVID-19 pandemic, including steep cuts to many of the specialties that have been on the front lines in efforts to treat patients in places with widespread infection, is unconscionable,” Madara wrote.

Madara also said specialties scheduled for payment reductions include those least able to make up for the lack of in-person care as a result of the uptick in telehealth during the pandemic.

A chart in the draft physician fee schedule (Table 90) shows reductions for many specialties that do not routinely bill for office visits. The table shows an 8% cut for anesthesiologists, a 7% cut for general surgeons, and a 6% cut for ophthalmologists. Table 90 also shows an estimated 11% reduction for radiologists and a 9% drop for pathologists.

The draft rule notes that these figures are based upon estimates of aggregate allowed charges across all services, so they may not reflect what any particular clinician might receive.

In total, Table 90 shows how the E/M changes and connected offsets would affect more than 50 fields of medicine. The proposal includes a 17% expected increase for endocrinologists and a 14% bump for those in hematology/oncology. There are expected increases of 13% for family practice and 4% for internal medicine.

This reshuffling of payments among specialties is only part of the 2021 E/M overhaul. There’s strong support for other aspects, making it unlikely that CMS would consider dropping the plan entirely.

“CMS’ new office visit policy will lead to significant administrative burden reduction and will better describe and recognize the resources involved in clinical office visits as they are performed today,” AMA’s Madara wrote in his comment.

Changes for the billing framework for E/M slated to start in 2021 are the result of substantial collaboration by an AMA-convened work group, which brought together more than 170 state medical and specialty societies, Madara said in his comment.

CMS has been developing this plan for several years. It outlined this 2021 E/M overhaul in the 2020 Medicare physician fee schedule finalized last year.

Madara urged CMS to proceed with the E/M changes but also “exercise the full breadth and depth of its administrative authority” to avoid or minimize the planned cuts.

“To be clear, we are not asking CMS to phase in implementation of the E/M changes but rather to phase in the payment reductions for certain specialties and health professionals in 2021 due to budget neutrality,” he wrote.

Other groups asking CMS to waive the budget-neutrality requirement include the American College of Physicians, the American College of Emergency Physicians, the American Society for Radiation Oncology, and the American Society of Neuroradiology.

The American Academy of Family Physicians (AAFP) asked CMS to temporarily waive the budget-neutrality requirement and pressed the agency to maintain the underlying principle of the E/M overhaul.

“Should HHS [Department of Health and Human Services] use its authority to waive budget neutrality, we also recommend that CMS finalize a reinstatement plan for the conversion factor reductions that provides physician practices with ample time to prepare and does not result in a financial cliff,” wrote John S. Cullen, MD, board chair for AAFP, in a September 28 comment to CMS.

Owing to the declaration of a public health emergency, HHS could use a special provision known as 1135 waiver authority to waive budget-neutrality requirements, Cullen wrote.

“The AAFP understands that HHS’ authority is limited by the timing of the end of the public health emergency, but we believe that this approach will provide Congress with needed time to enact an accompanying legislative solution,” he wrote.
 

Lawmakers weigh in

Lawmakers in both political parties have asked CMS to reconsider the offsets in the E/M overhaul.

Rep. Michael C. Burgess, MD (R-TX), who practiced as an obstetrician before joining Congress, in October introduced a bill with Rep. Bobby Rush (D-IL) that would provide for a 1-year waiver of budget-neutrality adjustments under the Medicare physician fee schedule.

Burgess and Rush were among the more than 160 members of Congress who signed a September letter to CMS asking the agency to act on its own to drop the budget-neutrality requirement. In the letter, led by Rep. Roger Marshall, MD (R-KS), the lawmakers acknowledge the usual legal requirements for CMS to offset payment increases in the physician fee schedule with cuts. But the lawmakers said the national public health emergency allows CMS to work around this.

“Given the effects of the COVID-19 pandemic, we believe you have the regulatory authority to immediately address these inequities,” the lawmakers wrote. “There is also the need to consider how the outbreak will be in the fall/winter months and if postponing certain elective procedures will go back into effect, per CMS’ recommendations.

“While we understand that legislative action may also be required to address this issue, given the January 1, 2021 effective date, we would ask you to take immediate actions to delay or mitigate these cuts while allowing the scheduled increases to go into effect,” the lawmakers said in closing their letter. “This approach will give Congress sufficient time to develop a meaningful solution and to address these looming needs.”

Another option might be for CMS to preserve the budget-neutrality claim for the 2021 physician fee schedule but soften the blow on specialties, Brian Fortune, president of the consulting firm Farragut Square Group, told Medscape Medical News. A former staffer for Republican leadership in the House of Representatives, Fortune has for more than 20 years followed Medicare policy.

The agency could redo some of the assumptions used in estimating the offsets, he said, adding that in the draft rule, CMS appears to be seeking feedback that could help it with new calculations.

“CMS has been looking for a way out,” Fortune said. “CMS could remodel the assumptions, and the cuts could drop by half or more.

“The agency has several options to get creative as the need arises,” he said.

“Overvalued” vs “devalued”

In its comment to CMS, though, MedPAC argued strongly for maintaining the offsets. The commission has for several years been investigating ways to use Medicare’s payment policies as a tool to boost the ranks of clinicians who provide primary care.

A reshuffling of payments among specialties is needed to address a known imbalance in which Medicare for many years has “overvalued” procedures at the expense of other medical care, wrote Michael E. Chernew, PhD, the chairman of MedPAC, in an October 2 comment to CMS.

“Some types of services — such as procedures, imaging, and tests — experience efficiency gains over time, as advances in technology, technique, and clinical practice enable clinicians to deliver them faster,” he wrote. “However, E&M office/outpatient visits do not lend themselves to such efficiency gains because they consist largely of activities that require the clinician’s time.”

Medicare’s payment policies have thus “passively devalued” the time many clinicians spend on office visits, helping to skew the decisions of young physicians toward specialties, according to Chernew.

Reshuffling payment away from specialties that are now “overvalued” is needed to “remedy several years of passive devaluation,” he wrote.

The median income in 2018 for primary care physicians was $243,000 in 2018, whereas that of specialists such as surgeons was $426,000, Chernew said in the letter, citing MedPAC research.

These figures echo the findings of Medscape’s most recent annual physician compensation report.

As one of the largest buyers of medical services, Medicare has significant influence on the practice of medicine in the United States. In 2018 alone, Medicare directly paid $70.5 billion for clinician services. Its payment policies already may have shaped the pool of clinicians available to treat people enrolled in Medicare, which covers those aged 65 years and older, Chernew said.

“The US has over three times as many specialists as primary care physicians, which could explain why MedPAC’s annual survey of Medicare beneficiaries has repeatedly found that beneficiaries who are looking for a new physician report having an easier time finding a new specialist than a new primary care provider,” he wrote.

“Access to primary care physicians could worsen in the future as the number of primary care physicians in the US, after remaining flat for several years, has actually started to decline,” Chernew said.

This article first appeared on Medscape.com.

Medicare officials must soon decide whether to kick off next year with a shift of money away from specialties centered around procedures and toward primary care and other fields more focused on office visits.

A planned overhaul of reimbursement for evaluation and management (E/M) services emerged as perhaps the most contentious issue connected to Medicare’s 2021 payment policies for clinicians.

roobcio/Thinkstock

The Centers for Medicare & Medicaid Services (CMS) included the planned E/M overhaul — and accompanying offsets — in the draft 2021 physician fee schedule, released in August. The draft fee schedule drew at least 45,675 responses by October 5, the deadline for offering comments, with many of the responses addressing the E/M overhaul.

The influential Medicare Payment Advisory Commission (MedPAC) “strongly” endorsed the “budget-neutral” approach taken with the E/M overhaul. This planned reshuffling of payments is a step toward addressing a shortfall of primary care clinicians, inasmuch as it would help make this field more financially appealing, MedPAC said in an October 2 letter to CMS.

In contrast, physician organizations, including the American Medical Association (AMA), asked CMS to waive or revise the budget-neutral aspect of the E/M overhaul. Among the specialties slated for reductions are those deeply involved with the response to the pandemic, wrote James L. Madara, AMA’s chief executive officer, in an October 5 comment to CMS. Emergency medicine as a field would see a 6% cut, and infectious disease specialists, a 4% reduction.

“Payment reductions of this magnitude would be a major problem at any time, but to impose cuts of this magnitude during or immediately after the COVID-19 pandemic, including steep cuts to many of the specialties that have been on the front lines in efforts to treat patients in places with widespread infection, is unconscionable,” Madara wrote.

Madara also said specialties scheduled for payment reductions include those least able to make up for the lack of in-person care as a result of the uptick in telehealth during the pandemic.

A chart in the draft physician fee schedule (Table 90) shows reductions for many specialties that do not routinely bill for office visits. The table shows an 8% cut for anesthesiologists, a 7% cut for general surgeons, and a 6% cut for ophthalmologists. Table 90 also shows an estimated 11% reduction for radiologists and a 9% drop for pathologists.

The draft rule notes that these figures are based upon estimates of aggregate allowed charges across all services, so they may not reflect what any particular clinician might receive.

In total, Table 90 shows how the E/M changes and connected offsets would affect more than 50 fields of medicine. The proposal includes a 17% expected increase for endocrinologists and a 14% bump for those in hematology/oncology. There are expected increases of 13% for family practice and 4% for internal medicine.

This reshuffling of payments among specialties is only part of the 2021 E/M overhaul. There’s strong support for other aspects, making it unlikely that CMS would consider dropping the plan entirely.

“CMS’ new office visit policy will lead to significant administrative burden reduction and will better describe and recognize the resources involved in clinical office visits as they are performed today,” AMA’s Madara wrote in his comment.

Changes for the billing framework for E/M slated to start in 2021 are the result of substantial collaboration by an AMA-convened work group, which brought together more than 170 state medical and specialty societies, Madara said in his comment.

CMS has been developing this plan for several years. It outlined this 2021 E/M overhaul in the 2020 Medicare physician fee schedule finalized last year.

Madara urged CMS to proceed with the E/M changes but also “exercise the full breadth and depth of its administrative authority” to avoid or minimize the planned cuts.

“To be clear, we are not asking CMS to phase in implementation of the E/M changes but rather to phase in the payment reductions for certain specialties and health professionals in 2021 due to budget neutrality,” he wrote.

Other groups asking CMS to waive the budget-neutrality requirement include the American College of Physicians, the American College of Emergency Physicians, the American Society for Radiation Oncology, and the American Society of Neuroradiology.

The American Academy of Family Physicians (AAFP) asked CMS to temporarily waive the budget-neutrality requirement and pressed the agency to maintain the underlying principle of the E/M overhaul.

“Should HHS [Department of Health and Human Services] use its authority to waive budget neutrality, we also recommend that CMS finalize a reinstatement plan for the conversion factor reductions that provides physician practices with ample time to prepare and does not result in a financial cliff,” wrote John S. Cullen, MD, board chair for AAFP, in a September 28 comment to CMS.

Owing to the declaration of a public health emergency, HHS could use a special provision known as 1135 waiver authority to waive budget-neutrality requirements, Cullen wrote.

“The AAFP understands that HHS’ authority is limited by the timing of the end of the public health emergency, but we believe that this approach will provide Congress with needed time to enact an accompanying legislative solution,” he wrote.
 

Lawmakers weigh in

Lawmakers in both political parties have asked CMS to reconsider the offsets in the E/M overhaul.

Rep. Michael C. Burgess, MD (R-TX), who practiced as an obstetrician before joining Congress, in October introduced a bill with Rep. Bobby Rush (D-IL) that would provide for a 1-year waiver of budget-neutrality adjustments under the Medicare physician fee schedule.

Burgess and Rush were among the more than 160 members of Congress who signed a September letter to CMS asking the agency to act on its own to drop the budget-neutrality requirement. In the letter, led by Rep. Roger Marshall, MD (R-KS), the lawmakers acknowledge the usual legal requirements for CMS to offset payment increases in the physician fee schedule with cuts. But the lawmakers said the national public health emergency allows CMS to work around this.

“Given the effects of the COVID-19 pandemic, we believe you have the regulatory authority to immediately address these inequities,” the lawmakers wrote. “There is also the need to consider how the outbreak will be in the fall/winter months and if postponing certain elective procedures will go back into effect, per CMS’ recommendations.

“While we understand that legislative action may also be required to address this issue, given the January 1, 2021 effective date, we would ask you to take immediate actions to delay or mitigate these cuts while allowing the scheduled increases to go into effect,” the lawmakers said in closing their letter. “This approach will give Congress sufficient time to develop a meaningful solution and to address these looming needs.”

Another option might be for CMS to preserve the budget-neutrality claim for the 2021 physician fee schedule but soften the blow on specialties, Brian Fortune, president of the consulting firm Farragut Square Group, told Medscape Medical News. A former staffer for Republican leadership in the House of Representatives, Fortune has for more than 20 years followed Medicare policy.

The agency could redo some of the assumptions used in estimating the offsets, he said, adding that in the draft rule, CMS appears to be seeking feedback that could help it with new calculations.

“CMS has been looking for a way out,” Fortune said. “CMS could remodel the assumptions, and the cuts could drop by half or more.

“The agency has several options to get creative as the need arises,” he said.

“Overvalued” vs “devalued”

In its comment to CMS, though, MedPAC argued strongly for maintaining the offsets. The commission has for several years been investigating ways to use Medicare’s payment policies as a tool to boost the ranks of clinicians who provide primary care.

A reshuffling of payments among specialties is needed to address a known imbalance in which Medicare for many years has “overvalued” procedures at the expense of other medical care, wrote Michael E. Chernew, PhD, the chairman of MedPAC, in an October 2 comment to CMS.

“Some types of services — such as procedures, imaging, and tests — experience efficiency gains over time, as advances in technology, technique, and clinical practice enable clinicians to deliver them faster,” he wrote. “However, E&M office/outpatient visits do not lend themselves to such efficiency gains because they consist largely of activities that require the clinician’s time.”

Medicare’s payment policies have thus “passively devalued” the time many clinicians spend on office visits, helping to skew the decisions of young physicians toward specialties, according to Chernew.

Reshuffling payment away from specialties that are now “overvalued” is needed to “remedy several years of passive devaluation,” he wrote.

The median income in 2018 for primary care physicians was $243,000 in 2018, whereas that of specialists such as surgeons was $426,000, Chernew said in the letter, citing MedPAC research.

These figures echo the findings of Medscape’s most recent annual physician compensation report.

As one of the largest buyers of medical services, Medicare has significant influence on the practice of medicine in the United States. In 2018 alone, Medicare directly paid $70.5 billion for clinician services. Its payment policies already may have shaped the pool of clinicians available to treat people enrolled in Medicare, which covers those aged 65 years and older, Chernew said.

“The US has over three times as many specialists as primary care physicians, which could explain why MedPAC’s annual survey of Medicare beneficiaries has repeatedly found that beneficiaries who are looking for a new physician report having an easier time finding a new specialist than a new primary care provider,” he wrote.

“Access to primary care physicians could worsen in the future as the number of primary care physicians in the US, after remaining flat for several years, has actually started to decline,” Chernew said.

This article first appeared on Medscape.com.

Unlike previous studies focused on vaccine effectiveness (VE) in ambulatory care office visits, Angela P. Campbell, MD, MPH, and associates have uncovered evidence of the overall benefit influenza vaccines play in reducing hospitalizations and emergency department visits in pediatric influenza patients.

Yarinca/istockphoto

“Our data provide important VE estimates against severe influenza in children,” the researchers noted in Pediatrics, adding that the findings “provide important evidence supporting the annual recommendation that all children 6 months and older should receive influenza vaccination.”

Dr. Campbell and colleagues collected ongoing surveillance data from the New Vaccine Surveillance Network (NVSN), which is a network of pediatric hospitals across seven cities, including Kansas City, Mo.; Rochester, N.Y.; Cincinnati; Pittsburgh; Nashville, Tenn.; Houston; and Seattle. The influenza season encompassed the period Nov. 7, 2018 to June 21, 2019.

A total of 2,748 hospitalized children and 2,676 children who had completed ED visits that did not lead to hospitalization were included. Once those under 6 months were excluded, 1,792 hospitalized children were included in the VE analysis; of these, 226 (13%) tested positive for influenza infection, including 211 (93%) with influenza A viruses and 15 (7%) with influenza B viruses. Fully 1,611 of the patients (90%), had verified vaccine status, while 181 (10%) had solely parental reported vaccine status. The researchers reported 88 (5%) of the patients received mechanical ventilation and 7 (<1%) died.

Most noteworthy, the researchers observed a significant reduction in laboratory-confirmed hospitalizations by 41% in children vaccinated against the flu. They further estimated a significant reduction in hospitalizations linked to A(H3N2) and A(H1N1)pdm09 viruses, even in the presence of circulating A(H3N2) viruses that differed from the A(H3N2) vaccine component.

Studies from other countries during the same time period showed that while “significant protection against influenza-associated ambulatory care visits and hospitalizations among children infected with A(H1N1)pdm09 viruses” was observed, the same could not be said for protection against A(H3N2) viruses, which varied among pediatric outpatients in the United States (24%), in England (17% outpatient; 31% inpatient), Europe (46%), and Canada (48%). They explained that such variation in vaccine protection is multifactorial, and includes virus-, host-, and environment-related factors. They also noted that regional variations in circulating viruses, host factors including age, imprinting, and previous vaccination could explain the study’s finding of vaccine protection against both A(H1N1)pdm09 and A(H3N2) viruses.

When comparing VE estimates between ED visits and hospitalizations, the researchers observed one significant difference, that “hospitalized children likely represent more medically complex patients, with 58% having underlying medical conditions and 38% reporting at lease one hospitalization in the past year, compared with 28% and 14% respectively, among ED participants.”

Strengths of the study included the prospective multisite enrollment that provided data across diverse locations and representation from pediatric hospitalizations and ED care, which were not previously strongly represented in the literature. The single-season study with small sample size was considered a limitation, as was the inability to evaluate full and partial vaccine status. Vaccine data also were limited for many of the ED patients observed.

Dr. Campbell and colleagues did caution that while they consider their test-negative design optimal for evaluating both hospitalized and ED patients, they feel their results should not be “interpreted as VE against influenza-associated ambulatory care visits or infections that are not medically attended.”

In a separate interview, Michael E. Pichichero, MD, director of the Rochester General Hospital Research Institute and a clinical professor of pediatrics at the University of Rochester (N.Y.), observed: “There are really no surprises here. A well done contemporary study confirms again the benefits of annual influenza vaccinations for children. Viral coinfections involving SARS-CoV-2 and influenza have been reported from Australia to cause heightened illnesses. That observation provides further impetus for parents to have their children receive influenza vaccinations.”

The researchers cited multiple sources of financial support for their ongoing work, including Sanofi, Quidel, Moderna, Karius, GlaxoSmithKline, Merck, AstraZeneca, and Pfizer. Funding for this study was supported by the Centers for Disease Control and Prevention. Dr. Pichichero said he had no relevant financial disclosures.

SOURCE: Campbell AP et al. Pediatrics. 2020. doi: 10.1542/peds.2020-1368.

Unlike previous studies focused on vaccine effectiveness (VE) in ambulatory care office visits, Angela P. Campbell, MD, MPH, and associates have uncovered evidence of the overall benefit influenza vaccines play in reducing hospitalizations and emergency department visits in pediatric influenza patients.

Yarinca/istockphoto

“Our data provide important VE estimates against severe influenza in children,” the researchers noted in Pediatrics, adding that the findings “provide important evidence supporting the annual recommendation that all children 6 months and older should receive influenza vaccination.”

Dr. Campbell and colleagues collected ongoing surveillance data from the New Vaccine Surveillance Network (NVSN), which is a network of pediatric hospitals across seven cities, including Kansas City, Mo.; Rochester, N.Y.; Cincinnati; Pittsburgh; Nashville, Tenn.; Houston; and Seattle. The influenza season encompassed the period Nov. 7, 2018 to June 21, 2019.

A total of 2,748 hospitalized children and 2,676 children who had completed ED visits that did not lead to hospitalization were included. Once those under 6 months were excluded, 1,792 hospitalized children were included in the VE analysis; of these, 226 (13%) tested positive for influenza infection, including 211 (93%) with influenza A viruses and 15 (7%) with influenza B viruses. Fully 1,611 of the patients (90%), had verified vaccine status, while 181 (10%) had solely parental reported vaccine status. The researchers reported 88 (5%) of the patients received mechanical ventilation and 7 (<1%) died.

Most noteworthy, the researchers observed a significant reduction in laboratory-confirmed hospitalizations by 41% in children vaccinated against the flu. They further estimated a significant reduction in hospitalizations linked to A(H3N2) and A(H1N1)pdm09 viruses, even in the presence of circulating A(H3N2) viruses that differed from the A(H3N2) vaccine component.

Studies from other countries during the same time period showed that while “significant protection against influenza-associated ambulatory care visits and hospitalizations among children infected with A(H1N1)pdm09 viruses” was observed, the same could not be said for protection against A(H3N2) viruses, which varied among pediatric outpatients in the United States (24%), in England (17% outpatient; 31% inpatient), Europe (46%), and Canada (48%). They explained that such variation in vaccine protection is multifactorial, and includes virus-, host-, and environment-related factors. They also noted that regional variations in circulating viruses, host factors including age, imprinting, and previous vaccination could explain the study’s finding of vaccine protection against both A(H1N1)pdm09 and A(H3N2) viruses.

When comparing VE estimates between ED visits and hospitalizations, the researchers observed one significant difference, that “hospitalized children likely represent more medically complex patients, with 58% having underlying medical conditions and 38% reporting at lease one hospitalization in the past year, compared with 28% and 14% respectively, among ED participants.”

Strengths of the study included the prospective multisite enrollment that provided data across diverse locations and representation from pediatric hospitalizations and ED care, which were not previously strongly represented in the literature. The single-season study with small sample size was considered a limitation, as was the inability to evaluate full and partial vaccine status. Vaccine data also were limited for many of the ED patients observed.

Dr. Campbell and colleagues did caution that while they consider their test-negative design optimal for evaluating both hospitalized and ED patients, they feel their results should not be “interpreted as VE against influenza-associated ambulatory care visits or infections that are not medically attended.”

In a separate interview, Michael E. Pichichero, MD, director of the Rochester General Hospital Research Institute and a clinical professor of pediatrics at the University of Rochester (N.Y.), observed: “There are really no surprises here. A well done contemporary study confirms again the benefits of annual influenza vaccinations for children. Viral coinfections involving SARS-CoV-2 and influenza have been reported from Australia to cause heightened illnesses. That observation provides further impetus for parents to have their children receive influenza vaccinations.”

The researchers cited multiple sources of financial support for their ongoing work, including Sanofi, Quidel, Moderna, Karius, GlaxoSmithKline, Merck, AstraZeneca, and Pfizer. Funding for this study was supported by the Centers for Disease Control and Prevention. Dr. Pichichero said he had no relevant financial disclosures.

SOURCE: Campbell AP et al. Pediatrics. 2020. doi: 10.1542/peds.2020-1368.

Unlike previous studies focused on vaccine effectiveness (VE) in ambulatory care office visits, Angela P. Campbell, MD, MPH, and associates have uncovered evidence of the overall benefit influenza vaccines play in reducing hospitalizations and emergency department visits in pediatric influenza patients.

Yarinca/istockphoto

“Our data provide important VE estimates against severe influenza in children,” the researchers noted in Pediatrics, adding that the findings “provide important evidence supporting the annual recommendation that all children 6 months and older should receive influenza vaccination.”

Dr. Campbell and colleagues collected ongoing surveillance data from the New Vaccine Surveillance Network (NVSN), which is a network of pediatric hospitals across seven cities, including Kansas City, Mo.; Rochester, N.Y.; Cincinnati; Pittsburgh; Nashville, Tenn.; Houston; and Seattle. The influenza season encompassed the period Nov. 7, 2018 to June 21, 2019.

A total of 2,748 hospitalized children and 2,676 children who had completed ED visits that did not lead to hospitalization were included. Once those under 6 months were excluded, 1,792 hospitalized children were included in the VE analysis; of these, 226 (13%) tested positive for influenza infection, including 211 (93%) with influenza A viruses and 15 (7%) with influenza B viruses. Fully 1,611 of the patients (90%), had verified vaccine status, while 181 (10%) had solely parental reported vaccine status. The researchers reported 88 (5%) of the patients received mechanical ventilation and 7 (<1%) died.

Most noteworthy, the researchers observed a significant reduction in laboratory-confirmed hospitalizations by 41% in children vaccinated against the flu. They further estimated a significant reduction in hospitalizations linked to A(H3N2) and A(H1N1)pdm09 viruses, even in the presence of circulating A(H3N2) viruses that differed from the A(H3N2) vaccine component.

Studies from other countries during the same time period showed that while “significant protection against influenza-associated ambulatory care visits and hospitalizations among children infected with A(H1N1)pdm09 viruses” was observed, the same could not be said for protection against A(H3N2) viruses, which varied among pediatric outpatients in the United States (24%), in England (17% outpatient; 31% inpatient), Europe (46%), and Canada (48%). They explained that such variation in vaccine protection is multifactorial, and includes virus-, host-, and environment-related factors. They also noted that regional variations in circulating viruses, host factors including age, imprinting, and previous vaccination could explain the study’s finding of vaccine protection against both A(H1N1)pdm09 and A(H3N2) viruses.

When comparing VE estimates between ED visits and hospitalizations, the researchers observed one significant difference, that “hospitalized children likely represent more medically complex patients, with 58% having underlying medical conditions and 38% reporting at lease one hospitalization in the past year, compared with 28% and 14% respectively, among ED participants.”

Strengths of the study included the prospective multisite enrollment that provided data across diverse locations and representation from pediatric hospitalizations and ED care, which were not previously strongly represented in the literature. The single-season study with small sample size was considered a limitation, as was the inability to evaluate full and partial vaccine status. Vaccine data also were limited for many of the ED patients observed.

Dr. Campbell and colleagues did caution that while they consider their test-negative design optimal for evaluating both hospitalized and ED patients, they feel their results should not be “interpreted as VE against influenza-associated ambulatory care visits or infections that are not medically attended.”

In a separate interview, Michael E. Pichichero, MD, director of the Rochester General Hospital Research Institute and a clinical professor of pediatrics at the University of Rochester (N.Y.), observed: “There are really no surprises here. A well done contemporary study confirms again the benefits of annual influenza vaccinations for children. Viral coinfections involving SARS-CoV-2 and influenza have been reported from Australia to cause heightened illnesses. That observation provides further impetus for parents to have their children receive influenza vaccinations.”

The researchers cited multiple sources of financial support for their ongoing work, including Sanofi, Quidel, Moderna, Karius, GlaxoSmithKline, Merck, AstraZeneca, and Pfizer. Funding for this study was supported by the Centers for Disease Control and Prevention. Dr. Pichichero said he had no relevant financial disclosures.

SOURCE: Campbell AP et al. Pediatrics. 2020. doi: 10.1542/peds.2020-1368.

More than 225,000 excess deaths occurred in the United States from March to July 2020, compared with historic norms, with approximately two-thirds directly attributable to COVID-19. However, additional deaths could be indirectly related because people avoided emergency care during the pandemic, new research shows.

Deaths linked to COVID-19 varied by state and phase of the pandemic, as reported in a study from researchers at Virginia Commonwealth University and Yale University that was published online October 12 in JAMA.

Another study published online simultaneously in JAMA took more of an international perspective. Investigators from the University of Pennsylvania and Harvard University found that in America there were more excess deaths and there was higher all-cause mortality during the pandemic than in 18 other countries.

Although the ongoing number of deaths attributable to COVID-19 continues to garner attention, there can be a lag of weeks or months in how long it takes some public health agencies to update their figures.

“For the public at large, the take-home message is twofold: that the number of deaths caused by the pandemic exceeds publicly reported COVID-19 death counts by 20% and that states that reopened or lifted restrictions early suffered a protracted surge in excess deaths that extended into the summer,” lead author of the US-focused study, Steven H. Woolf, MD, MPH, told Medscape Medical News.

The take-away for physicians is in the bigger picture – it is likely that the COVID-19 pandemic is responsible for deaths from other conditions as well. “Surges in COVID-19 were accompanied by an increase in deaths attributed to other causes, such as heart disease and Alzheimer’s disease and dementia,” said Woolf, director emeritus and senior adviser at the Center on Society and Health and professor in the Department of Family Medicine and Population Health at the Virginia Commonwealth University School of Medicine in Richmond, Virginia.

The investigators identified 225,530 excess US deaths in the 5 months from March to July. They report that 67% were directly attributable to COVID-19.

Deaths linked to COVID-19 included those in which the disease was listed as an underlying or contributing cause. US total death rates are “remarkably consistent” year after year, and the investigators calculated a 20% overall jump in mortality.

The study included data from the National Center for Health Statistics and the US Census Bureau for 48 states and the District of Columbia. Connecticut and North Carolina were excluded because of missing data.

Woolf and colleagues also found statistically higher rates of deaths from two other causes, heart disease and Alzheimer’s disease/dementia.
 

Altered states

New York, New Jersey, Massachusetts, Louisiana, Arizona, Mississippi, Maryland, Delaware, Rhode Island, and Michigan had the highest per capita excess death rates. Three states experienced the shortest epidemics during the study period: New York, New Jersey, and Massachusetts.

Some lessons could be learned by looking at how individual states managed large numbers of people with COVID-19. “Although we suspected that states that reopened early might have put themselves at risk of a pandemic surge, the consistency with which that occurred and the devastating numbers of deaths they suffered was a surprise,” Woolf said.

“The goal of our study is not to look in the rearview mirror and lament what happened months ago but to learn the lesson going forward: Our country will be unable to take control of this pandemic without more robust efforts to control community spread,” Woolf said. “Our study found that states that did this well, such as New York and New Jersey, experienced large surges but bent the curve and were back to baseline in less than 10 weeks.

“If we could do this as a country, countless lives could be saved.”
 

A global perspective

The United States experienced high mortality linked to COVID-19, as well as high all-cause mortality, compared with 18 other countries, as reported in the study by University of Pennsylvania and Harvard University researchers.

The United States ranked third, with 72 deaths per 100,000 people, among countries with moderate or high mortality. Although perhaps not surprising given the state of SARS-CoV-2 infection across the United States, a question remains as to what extent the relatively high mortality rate is linked to early outbreaks vs “poor long-term response,” the researchers note.

Alyssa Bilinski, MSc, and lead author Ezekiel J. Emanuel, MD, PhD, chair of the Department of Medical Ethics and Health Policy at the University of Pennsylvania Perelman School of Medicine in Philadelphia, calculated the difference in COVID-19 deaths among countries through Sept. 19, 2020. On this date, the United States reported a total 198,589 COVID-19 deaths.

They calculated that, if the US death rates were similar to those in Australia, the United States would have experienced 187,661 fewer COVID-19 deaths. If similar to those of Canada, there would have been 117,622 fewer deaths in the United States.

The US death rate was lower than six other countries with high COVID-19 mortality in the early spring, including Belgium, Spain, and the United Kingdom. However, after May 10, the per capita mortality rate in the United States exceeded the others.

Between May 10 and Sept. 19, the death rate in Italy was 9.1 per 100,000, vs 36.9 per 100,000.

“After the first peak in early spring, US death rates from COVID-19 and from all causes remained higher than even countries with high COVID-19 mortality,” the researchers note. “This may have been a result of several factors, including weak public health infrastructure and a decentralized, inconsistent US response to the pandemic.”
 

“Mortifying and motivating”

Woolf and colleagues estimate that more than 225,000 excess deaths occurred in recent months; this represents a 20% increase over expected deaths, note Harvey V. Fineberg, MD, PhD, of the Gordon and Betty Moore Foundation, in an accompanying editorial in JAMA.

“Importantly, a condition such as COVID-19 can contribute both directly and indirectly to excess mortality,” he writes.

Although the direct contribution to the mortality rates by those infected is straightforward, “the indirect contribution may relate to circumstances or choices due to the COVID-19 pandemic: for example, a patient who develops symptoms of a stroke is too concerned about COVID-19 to go to the emergency department, and a potentially reversible condition becomes fatal.”

Fineberg notes that “a general indication of the death toll from COVID-19 and the excess deaths related to the pandemic, as presented by Woolf et al, are sufficiently mortifying and motivating.”
 

“Profound human toll”

“The importance of the estimate by Woolf et al – which suggests that for the entirety of 2020, more than 400,000 excess deaths will occur – cannot be overstated, because it accounts for what could be declines in some causes of death, like motor vehicle crashes, but increases in others, like myocardial infarction,” write Howard Bauchner, MD, editor in chief of JAMA, and Phil B. Fontanarosa, MD, MBA, executive editor of JAMA, in another accompanying editorial.

“These deaths reflect a true measure of the human cost of the Great Pandemic of 2020,” they add.

The study from Emanuel and Bilinski was notable for calculating the excess COVID-19 and all-cause mortality to Sept. 2020, they note. “After the initial peak in early spring, US death rates from COVID-19 and from all causes remained higher than rates in countries with high COVID-19 mortality.”

“Few people will forget the Great Pandemic of 2020, where and how they lived, how it substantially changed their lives, and for many, the profound human toll it has taken,” Bauchner and Fontanarosa write.

The study by Woolf and colleagues was supported by National Center for Advancing Translational Sciences, the National Institute on Aging, and the National Institute of Allergy and Infectious Diseases. The study by Bilinski and Emanuel was partially funded by the Colton Foundation. Woolf, Emanuel, Fineberg, Bauchner, and Fontanarosa have disclosed no relevant financial relationships.
 

This article first appeared on Medscape.com.

More than 225,000 excess deaths occurred in the United States from March to July 2020, compared with historic norms, with approximately two-thirds directly attributable to COVID-19. However, additional deaths could be indirectly related because people avoided emergency care during the pandemic, new research shows.

Deaths linked to COVID-19 varied by state and phase of the pandemic, as reported in a study from researchers at Virginia Commonwealth University and Yale University that was published online October 12 in JAMA.

Another study published online simultaneously in JAMA took more of an international perspective. Investigators from the University of Pennsylvania and Harvard University found that in America there were more excess deaths and there was higher all-cause mortality during the pandemic than in 18 other countries.

Although the ongoing number of deaths attributable to COVID-19 continues to garner attention, there can be a lag of weeks or months in how long it takes some public health agencies to update their figures.

“For the public at large, the take-home message is twofold: that the number of deaths caused by the pandemic exceeds publicly reported COVID-19 death counts by 20% and that states that reopened or lifted restrictions early suffered a protracted surge in excess deaths that extended into the summer,” lead author of the US-focused study, Steven H. Woolf, MD, MPH, told Medscape Medical News.

The take-away for physicians is in the bigger picture – it is likely that the COVID-19 pandemic is responsible for deaths from other conditions as well. “Surges in COVID-19 were accompanied by an increase in deaths attributed to other causes, such as heart disease and Alzheimer’s disease and dementia,” said Woolf, director emeritus and senior adviser at the Center on Society and Health and professor in the Department of Family Medicine and Population Health at the Virginia Commonwealth University School of Medicine in Richmond, Virginia.

The investigators identified 225,530 excess US deaths in the 5 months from March to July. They report that 67% were directly attributable to COVID-19.

Deaths linked to COVID-19 included those in which the disease was listed as an underlying or contributing cause. US total death rates are “remarkably consistent” year after year, and the investigators calculated a 20% overall jump in mortality.

The study included data from the National Center for Health Statistics and the US Census Bureau for 48 states and the District of Columbia. Connecticut and North Carolina were excluded because of missing data.

Woolf and colleagues also found statistically higher rates of deaths from two other causes, heart disease and Alzheimer’s disease/dementia.
 

Altered states

New York, New Jersey, Massachusetts, Louisiana, Arizona, Mississippi, Maryland, Delaware, Rhode Island, and Michigan had the highest per capita excess death rates. Three states experienced the shortest epidemics during the study period: New York, New Jersey, and Massachusetts.

Some lessons could be learned by looking at how individual states managed large numbers of people with COVID-19. “Although we suspected that states that reopened early might have put themselves at risk of a pandemic surge, the consistency with which that occurred and the devastating numbers of deaths they suffered was a surprise,” Woolf said.

“The goal of our study is not to look in the rearview mirror and lament what happened months ago but to learn the lesson going forward: Our country will be unable to take control of this pandemic without more robust efforts to control community spread,” Woolf said. “Our study found that states that did this well, such as New York and New Jersey, experienced large surges but bent the curve and were back to baseline in less than 10 weeks.

“If we could do this as a country, countless lives could be saved.”
 

A global perspective

The United States experienced high mortality linked to COVID-19, as well as high all-cause mortality, compared with 18 other countries, as reported in the study by University of Pennsylvania and Harvard University researchers.

The United States ranked third, with 72 deaths per 100,000 people, among countries with moderate or high mortality. Although perhaps not surprising given the state of SARS-CoV-2 infection across the United States, a question remains as to what extent the relatively high mortality rate is linked to early outbreaks vs “poor long-term response,” the researchers note.

Alyssa Bilinski, MSc, and lead author Ezekiel J. Emanuel, MD, PhD, chair of the Department of Medical Ethics and Health Policy at the University of Pennsylvania Perelman School of Medicine in Philadelphia, calculated the difference in COVID-19 deaths among countries through Sept. 19, 2020. On this date, the United States reported a total 198,589 COVID-19 deaths.

They calculated that, if the US death rates were similar to those in Australia, the United States would have experienced 187,661 fewer COVID-19 deaths. If similar to those of Canada, there would have been 117,622 fewer deaths in the United States.

The US death rate was lower than six other countries with high COVID-19 mortality in the early spring, including Belgium, Spain, and the United Kingdom. However, after May 10, the per capita mortality rate in the United States exceeded the others.

Between May 10 and Sept. 19, the death rate in Italy was 9.1 per 100,000, vs 36.9 per 100,000.

“After the first peak in early spring, US death rates from COVID-19 and from all causes remained higher than even countries with high COVID-19 mortality,” the researchers note. “This may have been a result of several factors, including weak public health infrastructure and a decentralized, inconsistent US response to the pandemic.”
 

“Mortifying and motivating”

Woolf and colleagues estimate that more than 225,000 excess deaths occurred in recent months; this represents a 20% increase over expected deaths, note Harvey V. Fineberg, MD, PhD, of the Gordon and Betty Moore Foundation, in an accompanying editorial in JAMA.

“Importantly, a condition such as COVID-19 can contribute both directly and indirectly to excess mortality,” he writes.

Although the direct contribution to the mortality rates by those infected is straightforward, “the indirect contribution may relate to circumstances or choices due to the COVID-19 pandemic: for example, a patient who develops symptoms of a stroke is too concerned about COVID-19 to go to the emergency department, and a potentially reversible condition becomes fatal.”

Fineberg notes that “a general indication of the death toll from COVID-19 and the excess deaths related to the pandemic, as presented by Woolf et al, are sufficiently mortifying and motivating.”
 

“Profound human toll”

“The importance of the estimate by Woolf et al – which suggests that for the entirety of 2020, more than 400,000 excess deaths will occur – cannot be overstated, because it accounts for what could be declines in some causes of death, like motor vehicle crashes, but increases in others, like myocardial infarction,” write Howard Bauchner, MD, editor in chief of JAMA, and Phil B. Fontanarosa, MD, MBA, executive editor of JAMA, in another accompanying editorial.

“These deaths reflect a true measure of the human cost of the Great Pandemic of 2020,” they add.

The study from Emanuel and Bilinski was notable for calculating the excess COVID-19 and all-cause mortality to Sept. 2020, they note. “After the initial peak in early spring, US death rates from COVID-19 and from all causes remained higher than rates in countries with high COVID-19 mortality.”

“Few people will forget the Great Pandemic of 2020, where and how they lived, how it substantially changed their lives, and for many, the profound human toll it has taken,” Bauchner and Fontanarosa write.

The study by Woolf and colleagues was supported by National Center for Advancing Translational Sciences, the National Institute on Aging, and the National Institute of Allergy and Infectious Diseases. The study by Bilinski and Emanuel was partially funded by the Colton Foundation. Woolf, Emanuel, Fineberg, Bauchner, and Fontanarosa have disclosed no relevant financial relationships.
 

This article first appeared on Medscape.com.

More than 225,000 excess deaths occurred in the United States from March to July 2020, compared with historic norms, with approximately two-thirds directly attributable to COVID-19. However, additional deaths could be indirectly related because people avoided emergency care during the pandemic, new research shows.

Deaths linked to COVID-19 varied by state and phase of the pandemic, as reported in a study from researchers at Virginia Commonwealth University and Yale University that was published online October 12 in JAMA.

Another study published online simultaneously in JAMA took more of an international perspective. Investigators from the University of Pennsylvania and Harvard University found that in America there were more excess deaths and there was higher all-cause mortality during the pandemic than in 18 other countries.

Although the ongoing number of deaths attributable to COVID-19 continues to garner attention, there can be a lag of weeks or months in how long it takes some public health agencies to update their figures.

“For the public at large, the take-home message is twofold: that the number of deaths caused by the pandemic exceeds publicly reported COVID-19 death counts by 20% and that states that reopened or lifted restrictions early suffered a protracted surge in excess deaths that extended into the summer,” lead author of the US-focused study, Steven H. Woolf, MD, MPH, told Medscape Medical News.

The take-away for physicians is in the bigger picture – it is likely that the COVID-19 pandemic is responsible for deaths from other conditions as well. “Surges in COVID-19 were accompanied by an increase in deaths attributed to other causes, such as heart disease and Alzheimer’s disease and dementia,” said Woolf, director emeritus and senior adviser at the Center on Society and Health and professor in the Department of Family Medicine and Population Health at the Virginia Commonwealth University School of Medicine in Richmond, Virginia.

The investigators identified 225,530 excess US deaths in the 5 months from March to July. They report that 67% were directly attributable to COVID-19.

Deaths linked to COVID-19 included those in which the disease was listed as an underlying or contributing cause. US total death rates are “remarkably consistent” year after year, and the investigators calculated a 20% overall jump in mortality.

The study included data from the National Center for Health Statistics and the US Census Bureau for 48 states and the District of Columbia. Connecticut and North Carolina were excluded because of missing data.

Woolf and colleagues also found statistically higher rates of deaths from two other causes, heart disease and Alzheimer’s disease/dementia.
 

Altered states

New York, New Jersey, Massachusetts, Louisiana, Arizona, Mississippi, Maryland, Delaware, Rhode Island, and Michigan had the highest per capita excess death rates. Three states experienced the shortest epidemics during the study period: New York, New Jersey, and Massachusetts.

Some lessons could be learned by looking at how individual states managed large numbers of people with COVID-19. “Although we suspected that states that reopened early might have put themselves at risk of a pandemic surge, the consistency with which that occurred and the devastating numbers of deaths they suffered was a surprise,” Woolf said.

“The goal of our study is not to look in the rearview mirror and lament what happened months ago but to learn the lesson going forward: Our country will be unable to take control of this pandemic without more robust efforts to control community spread,” Woolf said. “Our study found that states that did this well, such as New York and New Jersey, experienced large surges but bent the curve and were back to baseline in less than 10 weeks.

“If we could do this as a country, countless lives could be saved.”
 

A global perspective

The United States experienced high mortality linked to COVID-19, as well as high all-cause mortality, compared with 18 other countries, as reported in the study by University of Pennsylvania and Harvard University researchers.

The United States ranked third, with 72 deaths per 100,000 people, among countries with moderate or high mortality. Although perhaps not surprising given the state of SARS-CoV-2 infection across the United States, a question remains as to what extent the relatively high mortality rate is linked to early outbreaks vs “poor long-term response,” the researchers note.

Alyssa Bilinski, MSc, and lead author Ezekiel J. Emanuel, MD, PhD, chair of the Department of Medical Ethics and Health Policy at the University of Pennsylvania Perelman School of Medicine in Philadelphia, calculated the difference in COVID-19 deaths among countries through Sept. 19, 2020. On this date, the United States reported a total 198,589 COVID-19 deaths.

They calculated that, if the US death rates were similar to those in Australia, the United States would have experienced 187,661 fewer COVID-19 deaths. If similar to those of Canada, there would have been 117,622 fewer deaths in the United States.

The US death rate was lower than six other countries with high COVID-19 mortality in the early spring, including Belgium, Spain, and the United Kingdom. However, after May 10, the per capita mortality rate in the United States exceeded the others.

Between May 10 and Sept. 19, the death rate in Italy was 9.1 per 100,000, vs 36.9 per 100,000.

“After the first peak in early spring, US death rates from COVID-19 and from all causes remained higher than even countries with high COVID-19 mortality,” the researchers note. “This may have been a result of several factors, including weak public health infrastructure and a decentralized, inconsistent US response to the pandemic.”
 

“Mortifying and motivating”

Woolf and colleagues estimate that more than 225,000 excess deaths occurred in recent months; this represents a 20% increase over expected deaths, note Harvey V. Fineberg, MD, PhD, of the Gordon and Betty Moore Foundation, in an accompanying editorial in JAMA.

“Importantly, a condition such as COVID-19 can contribute both directly and indirectly to excess mortality,” he writes.

Although the direct contribution to the mortality rates by those infected is straightforward, “the indirect contribution may relate to circumstances or choices due to the COVID-19 pandemic: for example, a patient who develops symptoms of a stroke is too concerned about COVID-19 to go to the emergency department, and a potentially reversible condition becomes fatal.”

Fineberg notes that “a general indication of the death toll from COVID-19 and the excess deaths related to the pandemic, as presented by Woolf et al, are sufficiently mortifying and motivating.”
 

“Profound human toll”

“The importance of the estimate by Woolf et al – which suggests that for the entirety of 2020, more than 400,000 excess deaths will occur – cannot be overstated, because it accounts for what could be declines in some causes of death, like motor vehicle crashes, but increases in others, like myocardial infarction,” write Howard Bauchner, MD, editor in chief of JAMA, and Phil B. Fontanarosa, MD, MBA, executive editor of JAMA, in another accompanying editorial.

“These deaths reflect a true measure of the human cost of the Great Pandemic of 2020,” they add.

The study from Emanuel and Bilinski was notable for calculating the excess COVID-19 and all-cause mortality to Sept. 2020, they note. “After the initial peak in early spring, US death rates from COVID-19 and from all causes remained higher than rates in countries with high COVID-19 mortality.”

“Few people will forget the Great Pandemic of 2020, where and how they lived, how it substantially changed their lives, and for many, the profound human toll it has taken,” Bauchner and Fontanarosa write.

The study by Woolf and colleagues was supported by National Center for Advancing Translational Sciences, the National Institute on Aging, and the National Institute of Allergy and Infectious Diseases. The study by Bilinski and Emanuel was partially funded by the Colton Foundation. Woolf, Emanuel, Fineberg, Bauchner, and Fontanarosa have disclosed no relevant financial relationships.
 

This article first appeared on Medscape.com.