MDedge Pediatrics

The Endocrine Society has issued a new position statement calling on all stakeholders, including clinicians, to play a role in reducing the cost of insulin for patients with diabetes in the United States.

“Addressing Insulin Access and Affordability: An Endocrine Society Position Statement,” was published online Jan. 12 in the Journal of Clinical Endocrinology and Metabolism.

“The society believes all stakeholders across the supply chain have a role to play in addressing the high price of insulin,” said the 11 authors, who are all members of the society’s advocacy and public outreach core committee.  

This is the first such statement from a major professional organization in 2021, which is the 100th anniversary of the discovery of insulin.

And the call for action was issued just a week prior to the inauguration of incoming U.S. President Joe Biden, who has pledged to “build on the Affordable Care Act by giving Americans more choice, reducing health care costs, and making our health care system less complex to navigate.”

The cost of insulin has nearly tripled in the past 15 years in the United States, and a lack of transparency in the drug supply chain has made it challenging to identify and address the causes of soaring costs.

The high cost of insulin has made access particularly difficult for people with diabetes with a low income, who have high-deductible health plans, are Medicare beneficiaries using Part B to cover insulin delivered via pump, or are in the Medicare Part D “donut hole,” as well as young adults once they reach their 26th birthday and can no longer be covered under their parents’ insurance.

“Inventors Frederick Banting and Charles Best sold the insulin patent for a mere $1 in the 1920s because they wanted their discovery to save lives and for insulin to be affordable and accessible to everyone who needed it,” said Endocrine Society President-elect Carol Wysham, MD, of the Rockwood/MultiCare Health Systems, Spokane, Wash.

“People with diabetes without full insurance are often paying increasing out-of-pocket costs for insulin resulting in many rationing their medication or skipping lifesaving doses altogether,” she said.

The society’s statement called for allowing government negotiation of drug prices and greater transparency across the supply chain to elucidate the reasons for rising insulin costs.  

For physicians in particular, they advised training in use of lower-cost human NPH and regular insulin for appropriate patients with type 2 diabetes, and considering patients’ individual financial and coverage status when prescribing insulin.

Pharmacists are advised to learn about and share information with patients about lower-cost options offered by manufacturers.

Other policy recommendations for relevant stakeholders include:

• Limit future insulin list price increases to the rate of inflation.
• Limit out-of-pocket costs without increasing premiums or deductibles by limiting cost sharing to copays of no more than $35, providing first-dollar coverage, or capping costs at no more than $100 per month.
• Eliminate rebates or pass savings from rebates along to consumers without increasing premiums or deductibles.
• Expedite approval of insulin biosimilars to create market competition.
• Include real-time benefit information in electronic medical records.
• Develop a payment model for Medicare Part B beneficiaries, as well as Part D, to lower out-of-pocket copays.

For manufacturers, the society also recommended improving patient assistance programs to be less restrictive and more accountable. And employers, they said, should limit copays without increasing premiums or deductibles, and seek plan options that benefit people with diabetes and provide education about these options during open enrollment.   

Of the 11 writing panel members, 4 have pharmaceutical industry disclosures.

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

The Endocrine Society has issued a new position statement calling on all stakeholders, including clinicians, to play a role in reducing the cost of insulin for patients with diabetes in the United States.

“Addressing Insulin Access and Affordability: An Endocrine Society Position Statement,” was published online Jan. 12 in the Journal of Clinical Endocrinology and Metabolism.

“The society believes all stakeholders across the supply chain have a role to play in addressing the high price of insulin,” said the 11 authors, who are all members of the society’s advocacy and public outreach core committee.  

This is the first such statement from a major professional organization in 2021, which is the 100th anniversary of the discovery of insulin.

And the call for action was issued just a week prior to the inauguration of incoming U.S. President Joe Biden, who has pledged to “build on the Affordable Care Act by giving Americans more choice, reducing health care costs, and making our health care system less complex to navigate.”

The cost of insulin has nearly tripled in the past 15 years in the United States, and a lack of transparency in the drug supply chain has made it challenging to identify and address the causes of soaring costs.

The high cost of insulin has made access particularly difficult for people with diabetes with a low income, who have high-deductible health plans, are Medicare beneficiaries using Part B to cover insulin delivered via pump, or are in the Medicare Part D “donut hole,” as well as young adults once they reach their 26th birthday and can no longer be covered under their parents’ insurance.

“Inventors Frederick Banting and Charles Best sold the insulin patent for a mere $1 in the 1920s because they wanted their discovery to save lives and for insulin to be affordable and accessible to everyone who needed it,” said Endocrine Society President-elect Carol Wysham, MD, of the Rockwood/MultiCare Health Systems, Spokane, Wash.

“People with diabetes without full insurance are often paying increasing out-of-pocket costs for insulin resulting in many rationing their medication or skipping lifesaving doses altogether,” she said.

The society’s statement called for allowing government negotiation of drug prices and greater transparency across the supply chain to elucidate the reasons for rising insulin costs.  

For physicians in particular, they advised training in use of lower-cost human NPH and regular insulin for appropriate patients with type 2 diabetes, and considering patients’ individual financial and coverage status when prescribing insulin.

Pharmacists are advised to learn about and share information with patients about lower-cost options offered by manufacturers.

Other policy recommendations for relevant stakeholders include:

• Limit future insulin list price increases to the rate of inflation.
• Limit out-of-pocket costs without increasing premiums or deductibles by limiting cost sharing to copays of no more than $35, providing first-dollar coverage, or capping costs at no more than $100 per month.
• Eliminate rebates or pass savings from rebates along to consumers without increasing premiums or deductibles.
• Expedite approval of insulin biosimilars to create market competition.
• Include real-time benefit information in electronic medical records.
• Develop a payment model for Medicare Part B beneficiaries, as well as Part D, to lower out-of-pocket copays.

For manufacturers, the society also recommended improving patient assistance programs to be less restrictive and more accountable. And employers, they said, should limit copays without increasing premiums or deductibles, and seek plan options that benefit people with diabetes and provide education about these options during open enrollment.   

Of the 11 writing panel members, 4 have pharmaceutical industry disclosures.

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

The Endocrine Society has issued a new position statement calling on all stakeholders, including clinicians, to play a role in reducing the cost of insulin for patients with diabetes in the United States.

“Addressing Insulin Access and Affordability: An Endocrine Society Position Statement,” was published online Jan. 12 in the Journal of Clinical Endocrinology and Metabolism.

“The society believes all stakeholders across the supply chain have a role to play in addressing the high price of insulin,” said the 11 authors, who are all members of the society’s advocacy and public outreach core committee.  

This is the first such statement from a major professional organization in 2021, which is the 100th anniversary of the discovery of insulin.

And the call for action was issued just a week prior to the inauguration of incoming U.S. President Joe Biden, who has pledged to “build on the Affordable Care Act by giving Americans more choice, reducing health care costs, and making our health care system less complex to navigate.”

The cost of insulin has nearly tripled in the past 15 years in the United States, and a lack of transparency in the drug supply chain has made it challenging to identify and address the causes of soaring costs.

The high cost of insulin has made access particularly difficult for people with diabetes with a low income, who have high-deductible health plans, are Medicare beneficiaries using Part B to cover insulin delivered via pump, or are in the Medicare Part D “donut hole,” as well as young adults once they reach their 26th birthday and can no longer be covered under their parents’ insurance.

“Inventors Frederick Banting and Charles Best sold the insulin patent for a mere $1 in the 1920s because they wanted their discovery to save lives and for insulin to be affordable and accessible to everyone who needed it,” said Endocrine Society President-elect Carol Wysham, MD, of the Rockwood/MultiCare Health Systems, Spokane, Wash.

“People with diabetes without full insurance are often paying increasing out-of-pocket costs for insulin resulting in many rationing their medication or skipping lifesaving doses altogether,” she said.

The society’s statement called for allowing government negotiation of drug prices and greater transparency across the supply chain to elucidate the reasons for rising insulin costs.  

For physicians in particular, they advised training in use of lower-cost human NPH and regular insulin for appropriate patients with type 2 diabetes, and considering patients’ individual financial and coverage status when prescribing insulin.

Pharmacists are advised to learn about and share information with patients about lower-cost options offered by manufacturers.

Other policy recommendations for relevant stakeholders include:

• Limit future insulin list price increases to the rate of inflation.
• Limit out-of-pocket costs without increasing premiums or deductibles by limiting cost sharing to copays of no more than $35, providing first-dollar coverage, or capping costs at no more than $100 per month.
• Eliminate rebates or pass savings from rebates along to consumers without increasing premiums or deductibles.
• Expedite approval of insulin biosimilars to create market competition.
• Include real-time benefit information in electronic medical records.
• Develop a payment model for Medicare Part B beneficiaries, as well as Part D, to lower out-of-pocket copays.

For manufacturers, the society also recommended improving patient assistance programs to be less restrictive and more accountable. And employers, they said, should limit copays without increasing premiums or deductibles, and seek plan options that benefit people with diabetes and provide education about these options during open enrollment.   

Of the 11 writing panel members, 4 have pharmaceutical industry disclosures.

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

Nostrum Laboratories has voluntarily recalled another lot of metformin HCl extended-release tablets 750-mg dosage, expanding their initial announcement in November 2020. According to the new notice, issued by the Food and Drug Administration earlier this week, the recalled tablets are off-white and oblong with a debossed ID “NM7.”

Wikimedia Commons/FitzColinGerald/ Creative Commons License

The lot number, NDC, and expiration dates can be found on the FDA website.

Nostrum noted that the tablets were distributed across the United States to wholesalers; these distributors are being notified of the recall and the company is arranging for the drug to be returned.

Metformin is the most prescribed medication worldwide for the treatment of type 2 diabetes.

Nostrum said that anyone in possession of any of the affected lots should consult their physician or pharmacist to obtain a replacement treatment option because it can be dangerous for patients with type 2 diabetes to stop taking metformin.

This new announcement expands further the number of metformin HCl extended-release tablets recalled in the United States because they contain potentially high levels of nitrosamines, also known as N-nitrosodimethylamine (NDMA), which are possible carcinogens.

The risks of nitrosamines are not clear. The FDA said 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.”

As well as the November recall of 2 lots of metformin by Nostrum, 76 more lots of metformin extended-release tablets were flagged in October 2020 from various manufacturers for possible contamination with NDMA, on top of an earlier recall for the same problem in May 2020.

More than 175 different drug combinations, all extended release with either 500 mg or 750 mg of metformin, have now been recalled since late May 2020, and a list of those recalled to November 2020 is available here.

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

Nostrum Laboratories has voluntarily recalled another lot of metformin HCl extended-release tablets 750-mg dosage, expanding their initial announcement in November 2020. According to the new notice, issued by the Food and Drug Administration earlier this week, the recalled tablets are off-white and oblong with a debossed ID “NM7.”

Wikimedia Commons/FitzColinGerald/ Creative Commons License

The lot number, NDC, and expiration dates can be found on the FDA website.

Nostrum noted that the tablets were distributed across the United States to wholesalers; these distributors are being notified of the recall and the company is arranging for the drug to be returned.

Metformin is the most prescribed medication worldwide for the treatment of type 2 diabetes.

Nostrum said that anyone in possession of any of the affected lots should consult their physician or pharmacist to obtain a replacement treatment option because it can be dangerous for patients with type 2 diabetes to stop taking metformin.

This new announcement expands further the number of metformin HCl extended-release tablets recalled in the United States because they contain potentially high levels of nitrosamines, also known as N-nitrosodimethylamine (NDMA), which are possible carcinogens.

The risks of nitrosamines are not clear. The FDA said 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.”

As well as the November recall of 2 lots of metformin by Nostrum, 76 more lots of metformin extended-release tablets were flagged in October 2020 from various manufacturers for possible contamination with NDMA, on top of an earlier recall for the same problem in May 2020.

More than 175 different drug combinations, all extended release with either 500 mg or 750 mg of metformin, have now been recalled since late May 2020, and a list of those recalled to November 2020 is available here.

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

Nostrum Laboratories has voluntarily recalled another lot of metformin HCl extended-release tablets 750-mg dosage, expanding their initial announcement in November 2020. According to the new notice, issued by the Food and Drug Administration earlier this week, the recalled tablets are off-white and oblong with a debossed ID “NM7.”

Wikimedia Commons/FitzColinGerald/ Creative Commons License

The lot number, NDC, and expiration dates can be found on the FDA website.

Nostrum noted that the tablets were distributed across the United States to wholesalers; these distributors are being notified of the recall and the company is arranging for the drug to be returned.

Metformin is the most prescribed medication worldwide for the treatment of type 2 diabetes.

Nostrum said that anyone in possession of any of the affected lots should consult their physician or pharmacist to obtain a replacement treatment option because it can be dangerous for patients with type 2 diabetes to stop taking metformin.

This new announcement expands further the number of metformin HCl extended-release tablets recalled in the United States because they contain potentially high levels of nitrosamines, also known as N-nitrosodimethylamine (NDMA), which are possible carcinogens.

The risks of nitrosamines are not clear. The FDA said 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.”

As well as the November recall of 2 lots of metformin by Nostrum, 76 more lots of metformin extended-release tablets were flagged in October 2020 from various manufacturers for possible contamination with NDMA, on top of an earlier recall for the same problem in May 2020.

More than 175 different drug combinations, all extended release with either 500 mg or 750 mg of metformin, have now been recalled since late May 2020, and a list of those recalled to November 2020 is available here.

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

Many scientific problems are complex. Finding the solution can require the concerted efforts of a team. Producing a vaccine for COVID-19 involved a multidisciplinary team with a variety of highly specialized expertises, extensive technological resources, and a history of previous scientific discoveries upon whose shoulders today’s scientists can stand.

Many ethical problems are also complex. Finding the ideal, multifaceted answer that addresses all the nuances of a social problem requires brilliant minds, a refined ability for logical analysis and rhetoric, the empowerment of the voices of all stakeholders, and attention to social values such as diversity and justice.

In both endeavors, the typical scientists and ethicists involved tend to presume that if they can determine an ideal solution, it will be rapidly and enthusiastically adopted and implemented for the betterment of society. That is, after all, exactly how those researchers would choose to act. Scientists see moral actions as having two steps. The hard part is deciding what is right. Doing the right thing is the easier task. This delusion is ubiquitous. Many scientists and ethicists recognize the delusion of the existence of a rational society, but proceed anyhow as if one exists.

There is a chorus of voices capable of debunking this delusion. Any priest who hears confessions will testify that the vast majority of harm comes from the failure to do what people already know is right, not from uncertainty, confusion, or ignorance. Psychologists and substance abuse counselors are inundated with people who are stuck doing harmful and self-destructive acts. Internists discuss diet and exercise with their patients, but find the advice is infrequently adopted. Master in business administration programs are devoted to training graduates in methods of motivating people to do what is right.

The response of the scientific establishment to the COVID-19 pandemic was imperfect. There were gaps in knowledge and some early information from China was misleading. The initial CDC test kit production was flawed. The early appeal for the public not to buy masks was strongly driven by a desire to preserve supplies for health care workers. Despite these missteps, the overall advice of scientists was wildly successful and beneficial. The goal was to flatten the curve, and a comparison of the April-June time frame with the November-January period shows markedly fewer COVID-19 cases, hospitalizations, and deaths. Confronted with the pandemic of the century, my assessment is that scientific establishment has performed well.

I am far more negative in my assessment of the institutions that support morality, form the social order, establish justice, and promote the general welfare. For instance, misinformation on social media is rampant, including conspiracy theories and outright denials of the pandemic. Scientific advice has been undercut and impugned. Policy recommendations of esteemed scientific institutions have been ignored. The public’s cooperation has fatigued. Laws on public gatherings, quarantines, and social distancing have been broken. Communitarian ethics and devotion to the common good have been left in a trash heap. The consequences have been hundreds of thousands of lives lost in 2020 and some states are on the brink of much worse.

Medical ethicists have debated in fine detail how to triage ventilators, ration antibody treatments, and prioritize vaccinations. Those policy recommendations have had limited influence. Medical ethics has inadequately addressed the age old problem of morality, which is getting people to behave as they know they ought. Modern medical ethics may have exacerbated the deviancy. Medical ethics for 50 years has emphasized replacing paternalism with autonomy, but it has not adequately promoted communitarian virtues, self-regulation, and personal integrity.

There were many accomplishments and many people to admire in 2020 when compared to historical actions by the health care professionals during crises. Doctors, confronted with the COVID-19 plague, have not abandoned the cities as happened in prior centuries. Patients have not been shunned like lepers, though the total-body protective equipment and the no-visitor policies come very close. Nurses have heroically provided bedside care, though I am haunted by one dissident nurse during a protest carrying a sign saying “Don’t call me a hero. I am being martyred against my will.”

As a scientist, I am prone to the delusion that, if I can build a better mouse trap, people will use it. I’ve lived with that delusion for decades. It carries over into my medical ethics work. Yet I see hospitals in California being overwhelmed by the surge on top of a surge due to unwise and unsafe holiday travel. I can see that optimized solutions aren’t the answer – it is better behavior by the public. I recall when I was a child, my mother would simply command, “Behave yourself.” And never, in any of those recollections, was I in doubt about which correct behavior she meant.
 

Dr. Powell is a pediatric hospitalist and clinical ethics consultant living in St. Louis. Email him at [email protected].

Many scientific problems are complex. Finding the solution can require the concerted efforts of a team. Producing a vaccine for COVID-19 involved a multidisciplinary team with a variety of highly specialized expertises, extensive technological resources, and a history of previous scientific discoveries upon whose shoulders today’s scientists can stand.

Many ethical problems are also complex. Finding the ideal, multifaceted answer that addresses all the nuances of a social problem requires brilliant minds, a refined ability for logical analysis and rhetoric, the empowerment of the voices of all stakeholders, and attention to social values such as diversity and justice.

In both endeavors, the typical scientists and ethicists involved tend to presume that if they can determine an ideal solution, it will be rapidly and enthusiastically adopted and implemented for the betterment of society. That is, after all, exactly how those researchers would choose to act. Scientists see moral actions as having two steps. The hard part is deciding what is right. Doing the right thing is the easier task. This delusion is ubiquitous. Many scientists and ethicists recognize the delusion of the existence of a rational society, but proceed anyhow as if one exists.

There is a chorus of voices capable of debunking this delusion. Any priest who hears confessions will testify that the vast majority of harm comes from the failure to do what people already know is right, not from uncertainty, confusion, or ignorance. Psychologists and substance abuse counselors are inundated with people who are stuck doing harmful and self-destructive acts. Internists discuss diet and exercise with their patients, but find the advice is infrequently adopted. Master in business administration programs are devoted to training graduates in methods of motivating people to do what is right.

The response of the scientific establishment to the COVID-19 pandemic was imperfect. There were gaps in knowledge and some early information from China was misleading. The initial CDC test kit production was flawed. The early appeal for the public not to buy masks was strongly driven by a desire to preserve supplies for health care workers. Despite these missteps, the overall advice of scientists was wildly successful and beneficial. The goal was to flatten the curve, and a comparison of the April-June time frame with the November-January period shows markedly fewer COVID-19 cases, hospitalizations, and deaths. Confronted with the pandemic of the century, my assessment is that scientific establishment has performed well.

I am far more negative in my assessment of the institutions that support morality, form the social order, establish justice, and promote the general welfare. For instance, misinformation on social media is rampant, including conspiracy theories and outright denials of the pandemic. Scientific advice has been undercut and impugned. Policy recommendations of esteemed scientific institutions have been ignored. The public’s cooperation has fatigued. Laws on public gatherings, quarantines, and social distancing have been broken. Communitarian ethics and devotion to the common good have been left in a trash heap. The consequences have been hundreds of thousands of lives lost in 2020 and some states are on the brink of much worse.

Medical ethicists have debated in fine detail how to triage ventilators, ration antibody treatments, and prioritize vaccinations. Those policy recommendations have had limited influence. Medical ethics has inadequately addressed the age old problem of morality, which is getting people to behave as they know they ought. Modern medical ethics may have exacerbated the deviancy. Medical ethics for 50 years has emphasized replacing paternalism with autonomy, but it has not adequately promoted communitarian virtues, self-regulation, and personal integrity.

There were many accomplishments and many people to admire in 2020 when compared to historical actions by the health care professionals during crises. Doctors, confronted with the COVID-19 plague, have not abandoned the cities as happened in prior centuries. Patients have not been shunned like lepers, though the total-body protective equipment and the no-visitor policies come very close. Nurses have heroically provided bedside care, though I am haunted by one dissident nurse during a protest carrying a sign saying “Don’t call me a hero. I am being martyred against my will.”

As a scientist, I am prone to the delusion that, if I can build a better mouse trap, people will use it. I’ve lived with that delusion for decades. It carries over into my medical ethics work. Yet I see hospitals in California being overwhelmed by the surge on top of a surge due to unwise and unsafe holiday travel. I can see that optimized solutions aren’t the answer – it is better behavior by the public. I recall when I was a child, my mother would simply command, “Behave yourself.” And never, in any of those recollections, was I in doubt about which correct behavior she meant.
 

Dr. Powell is a pediatric hospitalist and clinical ethics consultant living in St. Louis. Email him at [email protected].

Many scientific problems are complex. Finding the solution can require the concerted efforts of a team. Producing a vaccine for COVID-19 involved a multidisciplinary team with a variety of highly specialized expertises, extensive technological resources, and a history of previous scientific discoveries upon whose shoulders today’s scientists can stand.

Many ethical problems are also complex. Finding the ideal, multifaceted answer that addresses all the nuances of a social problem requires brilliant minds, a refined ability for logical analysis and rhetoric, the empowerment of the voices of all stakeholders, and attention to social values such as diversity and justice.

In both endeavors, the typical scientists and ethicists involved tend to presume that if they can determine an ideal solution, it will be rapidly and enthusiastically adopted and implemented for the betterment of society. That is, after all, exactly how those researchers would choose to act. Scientists see moral actions as having two steps. The hard part is deciding what is right. Doing the right thing is the easier task. This delusion is ubiquitous. Many scientists and ethicists recognize the delusion of the existence of a rational society, but proceed anyhow as if one exists.

There is a chorus of voices capable of debunking this delusion. Any priest who hears confessions will testify that the vast majority of harm comes from the failure to do what people already know is right, not from uncertainty, confusion, or ignorance. Psychologists and substance abuse counselors are inundated with people who are stuck doing harmful and self-destructive acts. Internists discuss diet and exercise with their patients, but find the advice is infrequently adopted. Master in business administration programs are devoted to training graduates in methods of motivating people to do what is right.

The response of the scientific establishment to the COVID-19 pandemic was imperfect. There were gaps in knowledge and some early information from China was misleading. The initial CDC test kit production was flawed. The early appeal for the public not to buy masks was strongly driven by a desire to preserve supplies for health care workers. Despite these missteps, the overall advice of scientists was wildly successful and beneficial. The goal was to flatten the curve, and a comparison of the April-June time frame with the November-January period shows markedly fewer COVID-19 cases, hospitalizations, and deaths. Confronted with the pandemic of the century, my assessment is that scientific establishment has performed well.

I am far more negative in my assessment of the institutions that support morality, form the social order, establish justice, and promote the general welfare. For instance, misinformation on social media is rampant, including conspiracy theories and outright denials of the pandemic. Scientific advice has been undercut and impugned. Policy recommendations of esteemed scientific institutions have been ignored. The public’s cooperation has fatigued. Laws on public gatherings, quarantines, and social distancing have been broken. Communitarian ethics and devotion to the common good have been left in a trash heap. The consequences have been hundreds of thousands of lives lost in 2020 and some states are on the brink of much worse.

Medical ethicists have debated in fine detail how to triage ventilators, ration antibody treatments, and prioritize vaccinations. Those policy recommendations have had limited influence. Medical ethics has inadequately addressed the age old problem of morality, which is getting people to behave as they know they ought. Modern medical ethics may have exacerbated the deviancy. Medical ethics for 50 years has emphasized replacing paternalism with autonomy, but it has not adequately promoted communitarian virtues, self-regulation, and personal integrity.

There were many accomplishments and many people to admire in 2020 when compared to historical actions by the health care professionals during crises. Doctors, confronted with the COVID-19 plague, have not abandoned the cities as happened in prior centuries. Patients have not been shunned like lepers, though the total-body protective equipment and the no-visitor policies come very close. Nurses have heroically provided bedside care, though I am haunted by one dissident nurse during a protest carrying a sign saying “Don’t call me a hero. I am being martyred against my will.”

As a scientist, I am prone to the delusion that, if I can build a better mouse trap, people will use it. I’ve lived with that delusion for decades. It carries over into my medical ethics work. Yet I see hospitals in California being overwhelmed by the surge on top of a surge due to unwise and unsafe holiday travel. I can see that optimized solutions aren’t the answer – it is better behavior by the public. I recall when I was a child, my mother would simply command, “Behave yourself.” And never, in any of those recollections, was I in doubt about which correct behavior she meant.
 

Dr. Powell is a pediatric hospitalist and clinical ethics consultant living in St. Louis. Email him at [email protected].

Patients with knee osteoarthritis (OA) who wear stable supportive shoes for 6 months have greater average reductions in knee pain when walking, compared with patients who wear flat flexible shoes, according to a randomized trial that included more than 160 patients.

copyright Nandyphotos/Thinkstock

“Contrary to our hypothesis, flat flexible shoes were not superior to stable supportive shoes,” reported Kade L. Paterson, PhD, of the University of Melbourne, and colleagues. Their study was published Jan. 12 in Annals of Internal Medicine.
 

Research gap

Abnormal knee joint loading has been implicated in the pathogenesis of knee OA. Guidelines recommend that patients wear appropriate footwear, but research has not established which shoes are best.

The 2019 American College of Rheumatology clinical guidelines note that “optimal footwear is likely to be of considerable importance for those with knee and/or hip OA,” but “the available studies do not define the best type of footwear to improve specific outcomes for knee or hip OA.”

Some doctors call for thick, shock-absorbing soles and arch supports, based on expert opinion. On the other hand, studies have found that knee loading is lower with flat flexible shoes, and preliminary evidence has suggested that flat flexible shoes may improve OA symptoms, the investigators said.

To study this question, they enrolled in their trial 164 patients aged 50 years and older who had radiographic medial knee OA. Participants had knee pain on most days of the previous month, tibiofemoral osteophytes, and moderate to severe tibiofemoral OA.

The researchers randomly assigned 82 participants to flat flexible shoes and 82 participants to stable supportive shoes, worn for at least 6 hours a day for 6 months.

In the trial, flat flexible shoes included Merrell Bare Access (men’s and women’s), Vivobarefoot Primus Lite (men’s and women’s), Vivobarefoot Mata Canvas (men’s), Converse Dainty Low (women’s), and Lacoste Marice (men’s).

Stable supportive shoes included ASICS Kayano (men’s and women’s), Merrell Jungle Moc (men’s), Nike Air Max 90 Ultra (women’s), Rockport Edge Hill (men’s), and New Balance 624 (women’s).

After participants were randomly assigned to a group, they chose two different pairs of shoes from their assigned footwear group.

“Participants were not told that the purpose of the study was to compare flat flexible with stable supportive shoes,” the researchers noted. “Instead, they were informed only that the trial was comparing the effects of ‘different shoes’ on knee OA symptoms.”

The primary outcomes were changes in walking pain on a 0-10 scale and physical function as assessed by the Western Ontario and McMaster Universities Osteoarthritis Index subscale at 6 months. The researchers also assessed other measures of pain and function, physical activity, and quality of life.

In all, 161 participants reported 6-month primary outcomes. The between-group difference in change in pain favored stable supportive shoes (mean difference, 1.1 units). In the flat flexible shoe group, overall average knee pain while walking decreased from 6.3 at baseline to 5.2 at 6 months. In the stable supportive shoe group, knee pain while walking decreased from 6.1 to 4.

In addition, improvements in knee-related quality of life and ipsilateral hip pain favored stable supportive shoes.

Participants who wore stable supportive shoes also were less likely to report adverse events, compared with those who wore flat flexible shoes (15% vs. 32%). Knee pain, ankle or foot pain, and shin or calf pain were among the adverse events reported.
 

‘Important work’

“This study suggests that more supportive shoes may help some patients with knee osteoarthritis feel better,” Constance R. Chu, MD, professor of orthopedic surgery at Stanford (Calif.) University, said in an interview. “Shoes, insoles, wedges, and high heels have been shown to change loading of the knee related to knee pain and osteoarthritis ... This is important work toward providing more specific information on the optimum shoes for people with different patterns and types of arthritis to reduce pain and disability from early knee OA.”

The reported changes in pain may be clinically meaningful for many but not all patients, the authors wrote. “Despite biomechanical evidence showing that flat flexible shoes reduce medial knee load compared with stable supportive shoes, our findings show that this does not translate to improved knee osteoarthritis symptoms,” they said. “This may be because relationships between knee loading and symptoms are not as strong as previously thought, or because the small reductions in medial knee load with flat flexible shoes are insufficient to substantively improve pain and function.”

The trial did not include a control group of patients who wore their usual shoes, and it focused on a select subgroup of patients with knee OA, which may limit the study’s generalizability, the authors noted. The study excluded people with lateral joint space narrowing greater than or equal to medial, those with recent or planned knee surgery, and those who were using shoe orthoses or customized shoes.

The study was supported by grants from the National Health and Medical Research Council. Dr. Chu had no relevant disclosures.

[email protected]

Patients with knee osteoarthritis (OA) who wear stable supportive shoes for 6 months have greater average reductions in knee pain when walking, compared with patients who wear flat flexible shoes, according to a randomized trial that included more than 160 patients.

copyright Nandyphotos/Thinkstock

“Contrary to our hypothesis, flat flexible shoes were not superior to stable supportive shoes,” reported Kade L. Paterson, PhD, of the University of Melbourne, and colleagues. Their study was published Jan. 12 in Annals of Internal Medicine.
 

Research gap

Abnormal knee joint loading has been implicated in the pathogenesis of knee OA. Guidelines recommend that patients wear appropriate footwear, but research has not established which shoes are best.

The 2019 American College of Rheumatology clinical guidelines note that “optimal footwear is likely to be of considerable importance for those with knee and/or hip OA,” but “the available studies do not define the best type of footwear to improve specific outcomes for knee or hip OA.”

Some doctors call for thick, shock-absorbing soles and arch supports, based on expert opinion. On the other hand, studies have found that knee loading is lower with flat flexible shoes, and preliminary evidence has suggested that flat flexible shoes may improve OA symptoms, the investigators said.

To study this question, they enrolled in their trial 164 patients aged 50 years and older who had radiographic medial knee OA. Participants had knee pain on most days of the previous month, tibiofemoral osteophytes, and moderate to severe tibiofemoral OA.

The researchers randomly assigned 82 participants to flat flexible shoes and 82 participants to stable supportive shoes, worn for at least 6 hours a day for 6 months.

In the trial, flat flexible shoes included Merrell Bare Access (men’s and women’s), Vivobarefoot Primus Lite (men’s and women’s), Vivobarefoot Mata Canvas (men’s), Converse Dainty Low (women’s), and Lacoste Marice (men’s).

Stable supportive shoes included ASICS Kayano (men’s and women’s), Merrell Jungle Moc (men’s), Nike Air Max 90 Ultra (women’s), Rockport Edge Hill (men’s), and New Balance 624 (women’s).

After participants were randomly assigned to a group, they chose two different pairs of shoes from their assigned footwear group.

“Participants were not told that the purpose of the study was to compare flat flexible with stable supportive shoes,” the researchers noted. “Instead, they were informed only that the trial was comparing the effects of ‘different shoes’ on knee OA symptoms.”

The primary outcomes were changes in walking pain on a 0-10 scale and physical function as assessed by the Western Ontario and McMaster Universities Osteoarthritis Index subscale at 6 months. The researchers also assessed other measures of pain and function, physical activity, and quality of life.

In all, 161 participants reported 6-month primary outcomes. The between-group difference in change in pain favored stable supportive shoes (mean difference, 1.1 units). In the flat flexible shoe group, overall average knee pain while walking decreased from 6.3 at baseline to 5.2 at 6 months. In the stable supportive shoe group, knee pain while walking decreased from 6.1 to 4.

In addition, improvements in knee-related quality of life and ipsilateral hip pain favored stable supportive shoes.

Participants who wore stable supportive shoes also were less likely to report adverse events, compared with those who wore flat flexible shoes (15% vs. 32%). Knee pain, ankle or foot pain, and shin or calf pain were among the adverse events reported.
 

‘Important work’

“This study suggests that more supportive shoes may help some patients with knee osteoarthritis feel better,” Constance R. Chu, MD, professor of orthopedic surgery at Stanford (Calif.) University, said in an interview. “Shoes, insoles, wedges, and high heels have been shown to change loading of the knee related to knee pain and osteoarthritis ... This is important work toward providing more specific information on the optimum shoes for people with different patterns and types of arthritis to reduce pain and disability from early knee OA.”

The reported changes in pain may be clinically meaningful for many but not all patients, the authors wrote. “Despite biomechanical evidence showing that flat flexible shoes reduce medial knee load compared with stable supportive shoes, our findings show that this does not translate to improved knee osteoarthritis symptoms,” they said. “This may be because relationships between knee loading and symptoms are not as strong as previously thought, or because the small reductions in medial knee load with flat flexible shoes are insufficient to substantively improve pain and function.”

The trial did not include a control group of patients who wore their usual shoes, and it focused on a select subgroup of patients with knee OA, which may limit the study’s generalizability, the authors noted. The study excluded people with lateral joint space narrowing greater than or equal to medial, those with recent or planned knee surgery, and those who were using shoe orthoses or customized shoes.

The study was supported by grants from the National Health and Medical Research Council. Dr. Chu had no relevant disclosures.

[email protected]

Patients with knee osteoarthritis (OA) who wear stable supportive shoes for 6 months have greater average reductions in knee pain when walking, compared with patients who wear flat flexible shoes, according to a randomized trial that included more than 160 patients.

copyright Nandyphotos/Thinkstock

“Contrary to our hypothesis, flat flexible shoes were not superior to stable supportive shoes,” reported Kade L. Paterson, PhD, of the University of Melbourne, and colleagues. Their study was published Jan. 12 in Annals of Internal Medicine.
 

Research gap

Abnormal knee joint loading has been implicated in the pathogenesis of knee OA. Guidelines recommend that patients wear appropriate footwear, but research has not established which shoes are best.

The 2019 American College of Rheumatology clinical guidelines note that “optimal footwear is likely to be of considerable importance for those with knee and/or hip OA,” but “the available studies do not define the best type of footwear to improve specific outcomes for knee or hip OA.”

Some doctors call for thick, shock-absorbing soles and arch supports, based on expert opinion. On the other hand, studies have found that knee loading is lower with flat flexible shoes, and preliminary evidence has suggested that flat flexible shoes may improve OA symptoms, the investigators said.

To study this question, they enrolled in their trial 164 patients aged 50 years and older who had radiographic medial knee OA. Participants had knee pain on most days of the previous month, tibiofemoral osteophytes, and moderate to severe tibiofemoral OA.

The researchers randomly assigned 82 participants to flat flexible shoes and 82 participants to stable supportive shoes, worn for at least 6 hours a day for 6 months.

In the trial, flat flexible shoes included Merrell Bare Access (men’s and women’s), Vivobarefoot Primus Lite (men’s and women’s), Vivobarefoot Mata Canvas (men’s), Converse Dainty Low (women’s), and Lacoste Marice (men’s).

Stable supportive shoes included ASICS Kayano (men’s and women’s), Merrell Jungle Moc (men’s), Nike Air Max 90 Ultra (women’s), Rockport Edge Hill (men’s), and New Balance 624 (women’s).

After participants were randomly assigned to a group, they chose two different pairs of shoes from their assigned footwear group.

“Participants were not told that the purpose of the study was to compare flat flexible with stable supportive shoes,” the researchers noted. “Instead, they were informed only that the trial was comparing the effects of ‘different shoes’ on knee OA symptoms.”

The primary outcomes were changes in walking pain on a 0-10 scale and physical function as assessed by the Western Ontario and McMaster Universities Osteoarthritis Index subscale at 6 months. The researchers also assessed other measures of pain and function, physical activity, and quality of life.

In all, 161 participants reported 6-month primary outcomes. The between-group difference in change in pain favored stable supportive shoes (mean difference, 1.1 units). In the flat flexible shoe group, overall average knee pain while walking decreased from 6.3 at baseline to 5.2 at 6 months. In the stable supportive shoe group, knee pain while walking decreased from 6.1 to 4.

In addition, improvements in knee-related quality of life and ipsilateral hip pain favored stable supportive shoes.

Participants who wore stable supportive shoes also were less likely to report adverse events, compared with those who wore flat flexible shoes (15% vs. 32%). Knee pain, ankle or foot pain, and shin or calf pain were among the adverse events reported.
 

‘Important work’

“This study suggests that more supportive shoes may help some patients with knee osteoarthritis feel better,” Constance R. Chu, MD, professor of orthopedic surgery at Stanford (Calif.) University, said in an interview. “Shoes, insoles, wedges, and high heels have been shown to change loading of the knee related to knee pain and osteoarthritis ... This is important work toward providing more specific information on the optimum shoes for people with different patterns and types of arthritis to reduce pain and disability from early knee OA.”

The reported changes in pain may be clinically meaningful for many but not all patients, the authors wrote. “Despite biomechanical evidence showing that flat flexible shoes reduce medial knee load compared with stable supportive shoes, our findings show that this does not translate to improved knee osteoarthritis symptoms,” they said. “This may be because relationships between knee loading and symptoms are not as strong as previously thought, or because the small reductions in medial knee load with flat flexible shoes are insufficient to substantively improve pain and function.”

The trial did not include a control group of patients who wore their usual shoes, and it focused on a select subgroup of patients with knee OA, which may limit the study’s generalizability, the authors noted. The study excluded people with lateral joint space narrowing greater than or equal to medial, those with recent or planned knee surgery, and those who were using shoe orthoses or customized shoes.

The study was supported by grants from the National Health and Medical Research Council. Dr. Chu had no relevant disclosures.

[email protected]

Physicians unaffiliated with health care systems continue to have difficulties obtaining COVID-19 vaccinations for themselves and their staffs, but that challenge appears to be fading in some states. Yet, in many places, primary care physicians (PCPs) still aren’t being enlisted in the national vaccination effort, despite their numbers and their relationships with patients.

In the first few weeks after the Pfizer and Moderna vaccines received emergency-use authorizations from the Food and Drug Administration, they were distributed mostly to hospitals, pharmacies, and long-term care facilities. Naturally, the hospitals and health care systems vaccinated their own staffs and employed physicians first.

So, even though the guidelines from the Centers for Disease Control and Prevention specify that all frontline health care workers should be included in the first vaccination group, many non–hospital-affiliated private practices have been left out in the cold. Non–patient-facing hospital staff members in some facilities, as well as first responders such as police officers and firefighters, have taken precedence over independent primary care physicians.

In Florida, residents older than 65 years were invited to get vaccinated before some physicians had received shots, Anders Gilberg, senior vice president of government affairs for the Medical Group Management Association, said in an interview.

While the Department of Health & Human Services is now telling states to give vaccinations to everyone over 65, that wasn’t the case back then.

Community doctors in some areas are still finding it hard to get vaccinated or even find out how to get shots. Yul Ejnes, MD, an internist and partner in Coastal Medical, an independent medical group based in Cranston, R.I., said in an interview that he and his practice staff haven’t been vaccinated, while the staffs of local hospitals have received their shots.

In response to repeated inquiries from his group, he said, the state health department recently said independent practice staffs will start getting vaccinated the week of Jan. 25.

Dr. Ejnes said he understood why hospital personnel went first: Hospitals have the necessary infrastructure, “and the staff in the emergency department and the ICU are caring for the sickest of the sick.”

For primary care doctors like himself who don’t work for the hospital, he said, “I don’t think an infrastructure to get us the vaccine in a timely manner was developed – or if it was developed, it hasn’t been communicated to us.”

Nevertheless, Dr. Ejnes stressed that primary care physicians in the community are just as vulnerable to the coronavirus as hospital clinicians. “We’re seeing patients who have COVID but don’t know they have it. I’m seeing 15 patients a day, and we screen them – as everyone else does – for symptoms and contact and travel, and check their temp,” he said. “But not a day goes by that one of the clinicians in this office doesn’t get a phone call from a patient who was seen a day or 2 earlier to tell them it turns out they were COVID positive. I’m spending 15 minutes in a 100–sq ft room with a patient for a routine visit. And as much as we’re masking and gloving and wearing eye protection, I wouldn’t consider us to be at low risk, especially with the high prevalence of disease.”

In some other states, the situation seems to be improving. Ada Stewart, MD, president of the American Academy of Family Physicians, said that she and her colleagues in a community health center in Columbia, S.C., are in the process of being vaccinated. She got her own shot Jan. 6 at a local hospital.

Her clinic’s staff hadn’t been vaccinated earlier, she said, because nobody in the practice knew the contact person at the hospital who could help access the vaccine doses. Other independent practices in her state are now getting vaccinated, she said, after Gov. Henry McMaster of South Carolina ordered that all health care providers in the top priority category be inoculated by Jan. 15. “At this point, the issues have been diminished.”

However, Dr. Stewart added, independent doctors in some states are still unable to get their shots. AAFP state chapters, as well as the national organization, are trying to persuade governors to ensure all of these physicians are vaccinated. “We’re trying to make sure that the voices of physicians not affiliated with health systems are being heard,” she said.
 

Lucky shot for doctor

David Boles, DO, a family doctor in Clarksville, Tenn., was able to get his first dose of vaccine just before Christmas, he said in an interview, because he was medical director of a hospice that had received vaccine doses for first responders. When some firefighters and police officers failed to show up for their appointments, the hospice called him and said he had 45 minutes to get to the site if he wanted to be vaccinated.

In early January, his colleagues and staff were also vaccinated, he said, after they were notified of their eligibility as frontline health care workers.

Dr. Boles agreed with Dr. Ejnes that community physicians and nurses are as much at risk as hospital clinicians, except for those intubating patients in the ICU. They may be even more vulnerable, he added, because they have less personal protective equipment than hospital doctors and nurses.

Jennifer Brull, MD, a family physician in Plainville, Kan., said there have been plenty of COVID-19 cases in her small rural community, and the local critical access hospital nearly ran out of beds at one point. Through a collaborative relationship among her clinic (the lone one in the area), the hospital, and the county health department, nearly every frontline health care worker has been vaccinated, and most clinicians in her group have gotten their second doses.

Both the hospital and the health department received vaccine supplies, she said, and everyone in the high-priority category was offered shots. So far, about 170 health care workers have been vaccinated, and only a few declined. More than 300 other people – most of them essential non–health care workers and people older than 65 – have signed up for the next round of shots.
 

Expanding vaccination effort

Dr. Brull’s practice is the exception among private medical groups around the country. Mr. Gilberg said the MGMA is “concerned that independent practices are playing second fiddle because they’ve been left behind.” Physicians and patient-facing staff in private groups should be getting vaccinated before hospital information technology workers and other non–patient-facing staffers.

Medical practices also can and should play a much bigger role in the overall vaccination effort. Mr. Gilberg has spoken to leaders of several large primary care groups “that have the freezers [for vaccines] and the capacity but haven’t been folded into the distribution plan, especially if they’re not part of the hospital system.”

While hospitals have the storage, he said, they’re not set up to distribute vaccines throughout their communities. “Most health care in this country is delivered outside of the hospital setting. That’s how you’re going to get people vaccinated.”

Ironically, he added, “the same PCPs that are having trouble getting themselves and their staffs vaccinated would be the physicians who could help with vaccine distribution.”

Dr. Brull’s clinic stands ready to help the hospital and health department vaccinate the local population. When sufficient vaccine supplies arrive, she said, she envisioned the doctors and staff administering 200-400 shots per day on Saturdays or weekends.

Dr. Brull was the exception – the other physicians interviewed hadn’t been invited to participate in vaccination efforts.

Dr. Ejnes said his group is capable of vaccinating its patients if it uses the Moderna vaccine, which doesn’t require a super-cold freezer. There are logistical challenges, including social distancing and finding space to observe vaccinated patients for 15 minutes after their shots, he noted. “We’re ready and willing, but realistic about how much we’ll be able to do in this effort.”

The fact that doctors haven’t been enlisted yet in this campaign speaks volumes about “the neglect of the public health infrastructure,” Dr. Ejnes said. “We’re not mobilizing as quickly as we should.”
 

Alternative routes

Dr. Boles’ group has a refrigerator for pediatric vaccines, which could be used to store the Moderna vaccine, he noted. Shots could be administered to patients in their cars in the parking lot, and they could wait for a while afterward until a nurse came out to verify they were okay.

Mass vaccination sites might also be deployed, as Los Angeles is doing with Dodger Stadium, and physicians could take shifts there in their spare time, Dr. Boles said. But for right now, he views pharmacies as the primary venues for community vaccination.

Of course, the number of pharmacists and pharmacy-employed advanced practice nurses is tiny, compared with the number of primary care doctors, mid-level practitioners, and nurses in ambulatory care practices. Moreover, Mr. Gilberg said, practices know from their electronic health records which patients are most at risk and should be vaccinated first. “Walgreens and CVS don’t know that.”

Physicians should also take the lead in vaccinations because of their patient relationships, he noted. “They can help educate [vaccine-hesitant] patients on why it’s important and dispel some of the rumors and the misinformation that has been politicized. That’s why we should engage physicians in an outpatient setting. And we have to vaccinate them and their staffs. Otherwise, we’re never going to get this rollout underway.”

Dr. Stewart agreed. “We are really the foundation of how we’re going to accomplish this. Most folks are seen by a primary care physician. We touch millions of lives,” she said. “We’re part of the community. Our patients trust us. We’re out there doing it already. We’re doing prevention, giving flu shots, and we’re trying to encourage people to get the COVID vaccine.”

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

Physicians unaffiliated with health care systems continue to have difficulties obtaining COVID-19 vaccinations for themselves and their staffs, but that challenge appears to be fading in some states. Yet, in many places, primary care physicians (PCPs) still aren’t being enlisted in the national vaccination effort, despite their numbers and their relationships with patients.

In the first few weeks after the Pfizer and Moderna vaccines received emergency-use authorizations from the Food and Drug Administration, they were distributed mostly to hospitals, pharmacies, and long-term care facilities. Naturally, the hospitals and health care systems vaccinated their own staffs and employed physicians first.

So, even though the guidelines from the Centers for Disease Control and Prevention specify that all frontline health care workers should be included in the first vaccination group, many non–hospital-affiliated private practices have been left out in the cold. Non–patient-facing hospital staff members in some facilities, as well as first responders such as police officers and firefighters, have taken precedence over independent primary care physicians.

In Florida, residents older than 65 years were invited to get vaccinated before some physicians had received shots, Anders Gilberg, senior vice president of government affairs for the Medical Group Management Association, said in an interview.

While the Department of Health & Human Services is now telling states to give vaccinations to everyone over 65, that wasn’t the case back then.

Community doctors in some areas are still finding it hard to get vaccinated or even find out how to get shots. Yul Ejnes, MD, an internist and partner in Coastal Medical, an independent medical group based in Cranston, R.I., said in an interview that he and his practice staff haven’t been vaccinated, while the staffs of local hospitals have received their shots.

In response to repeated inquiries from his group, he said, the state health department recently said independent practice staffs will start getting vaccinated the week of Jan. 25.

Dr. Ejnes said he understood why hospital personnel went first: Hospitals have the necessary infrastructure, “and the staff in the emergency department and the ICU are caring for the sickest of the sick.”

For primary care doctors like himself who don’t work for the hospital, he said, “I don’t think an infrastructure to get us the vaccine in a timely manner was developed – or if it was developed, it hasn’t been communicated to us.”

Nevertheless, Dr. Ejnes stressed that primary care physicians in the community are just as vulnerable to the coronavirus as hospital clinicians. “We’re seeing patients who have COVID but don’t know they have it. I’m seeing 15 patients a day, and we screen them – as everyone else does – for symptoms and contact and travel, and check their temp,” he said. “But not a day goes by that one of the clinicians in this office doesn’t get a phone call from a patient who was seen a day or 2 earlier to tell them it turns out they were COVID positive. I’m spending 15 minutes in a 100–sq ft room with a patient for a routine visit. And as much as we’re masking and gloving and wearing eye protection, I wouldn’t consider us to be at low risk, especially with the high prevalence of disease.”

In some other states, the situation seems to be improving. Ada Stewart, MD, president of the American Academy of Family Physicians, said that she and her colleagues in a community health center in Columbia, S.C., are in the process of being vaccinated. She got her own shot Jan. 6 at a local hospital.

Her clinic’s staff hadn’t been vaccinated earlier, she said, because nobody in the practice knew the contact person at the hospital who could help access the vaccine doses. Other independent practices in her state are now getting vaccinated, she said, after Gov. Henry McMaster of South Carolina ordered that all health care providers in the top priority category be inoculated by Jan. 15. “At this point, the issues have been diminished.”

However, Dr. Stewart added, independent doctors in some states are still unable to get their shots. AAFP state chapters, as well as the national organization, are trying to persuade governors to ensure all of these physicians are vaccinated. “We’re trying to make sure that the voices of physicians not affiliated with health systems are being heard,” she said.
 

Lucky shot for doctor

David Boles, DO, a family doctor in Clarksville, Tenn., was able to get his first dose of vaccine just before Christmas, he said in an interview, because he was medical director of a hospice that had received vaccine doses for first responders. When some firefighters and police officers failed to show up for their appointments, the hospice called him and said he had 45 minutes to get to the site if he wanted to be vaccinated.

In early January, his colleagues and staff were also vaccinated, he said, after they were notified of their eligibility as frontline health care workers.

Dr. Boles agreed with Dr. Ejnes that community physicians and nurses are as much at risk as hospital clinicians, except for those intubating patients in the ICU. They may be even more vulnerable, he added, because they have less personal protective equipment than hospital doctors and nurses.

Jennifer Brull, MD, a family physician in Plainville, Kan., said there have been plenty of COVID-19 cases in her small rural community, and the local critical access hospital nearly ran out of beds at one point. Through a collaborative relationship among her clinic (the lone one in the area), the hospital, and the county health department, nearly every frontline health care worker has been vaccinated, and most clinicians in her group have gotten their second doses.

Both the hospital and the health department received vaccine supplies, she said, and everyone in the high-priority category was offered shots. So far, about 170 health care workers have been vaccinated, and only a few declined. More than 300 other people – most of them essential non–health care workers and people older than 65 – have signed up for the next round of shots.
 

Expanding vaccination effort

Dr. Brull’s practice is the exception among private medical groups around the country. Mr. Gilberg said the MGMA is “concerned that independent practices are playing second fiddle because they’ve been left behind.” Physicians and patient-facing staff in private groups should be getting vaccinated before hospital information technology workers and other non–patient-facing staffers.

Medical practices also can and should play a much bigger role in the overall vaccination effort. Mr. Gilberg has spoken to leaders of several large primary care groups “that have the freezers [for vaccines] and the capacity but haven’t been folded into the distribution plan, especially if they’re not part of the hospital system.”

While hospitals have the storage, he said, they’re not set up to distribute vaccines throughout their communities. “Most health care in this country is delivered outside of the hospital setting. That’s how you’re going to get people vaccinated.”

Ironically, he added, “the same PCPs that are having trouble getting themselves and their staffs vaccinated would be the physicians who could help with vaccine distribution.”

Dr. Brull’s clinic stands ready to help the hospital and health department vaccinate the local population. When sufficient vaccine supplies arrive, she said, she envisioned the doctors and staff administering 200-400 shots per day on Saturdays or weekends.

Dr. Brull was the exception – the other physicians interviewed hadn’t been invited to participate in vaccination efforts.

Dr. Ejnes said his group is capable of vaccinating its patients if it uses the Moderna vaccine, which doesn’t require a super-cold freezer. There are logistical challenges, including social distancing and finding space to observe vaccinated patients for 15 minutes after their shots, he noted. “We’re ready and willing, but realistic about how much we’ll be able to do in this effort.”

The fact that doctors haven’t been enlisted yet in this campaign speaks volumes about “the neglect of the public health infrastructure,” Dr. Ejnes said. “We’re not mobilizing as quickly as we should.”
 

Alternative routes

Dr. Boles’ group has a refrigerator for pediatric vaccines, which could be used to store the Moderna vaccine, he noted. Shots could be administered to patients in their cars in the parking lot, and they could wait for a while afterward until a nurse came out to verify they were okay.

Mass vaccination sites might also be deployed, as Los Angeles is doing with Dodger Stadium, and physicians could take shifts there in their spare time, Dr. Boles said. But for right now, he views pharmacies as the primary venues for community vaccination.

Of course, the number of pharmacists and pharmacy-employed advanced practice nurses is tiny, compared with the number of primary care doctors, mid-level practitioners, and nurses in ambulatory care practices. Moreover, Mr. Gilberg said, practices know from their electronic health records which patients are most at risk and should be vaccinated first. “Walgreens and CVS don’t know that.”

Physicians should also take the lead in vaccinations because of their patient relationships, he noted. “They can help educate [vaccine-hesitant] patients on why it’s important and dispel some of the rumors and the misinformation that has been politicized. That’s why we should engage physicians in an outpatient setting. And we have to vaccinate them and their staffs. Otherwise, we’re never going to get this rollout underway.”

Dr. Stewart agreed. “We are really the foundation of how we’re going to accomplish this. Most folks are seen by a primary care physician. We touch millions of lives,” she said. “We’re part of the community. Our patients trust us. We’re out there doing it already. We’re doing prevention, giving flu shots, and we’re trying to encourage people to get the COVID vaccine.”

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

Physicians unaffiliated with health care systems continue to have difficulties obtaining COVID-19 vaccinations for themselves and their staffs, but that challenge appears to be fading in some states. Yet, in many places, primary care physicians (PCPs) still aren’t being enlisted in the national vaccination effort, despite their numbers and their relationships with patients.

In the first few weeks after the Pfizer and Moderna vaccines received emergency-use authorizations from the Food and Drug Administration, they were distributed mostly to hospitals, pharmacies, and long-term care facilities. Naturally, the hospitals and health care systems vaccinated their own staffs and employed physicians first.

So, even though the guidelines from the Centers for Disease Control and Prevention specify that all frontline health care workers should be included in the first vaccination group, many non–hospital-affiliated private practices have been left out in the cold. Non–patient-facing hospital staff members in some facilities, as well as first responders such as police officers and firefighters, have taken precedence over independent primary care physicians.

In Florida, residents older than 65 years were invited to get vaccinated before some physicians had received shots, Anders Gilberg, senior vice president of government affairs for the Medical Group Management Association, said in an interview.

While the Department of Health & Human Services is now telling states to give vaccinations to everyone over 65, that wasn’t the case back then.

Community doctors in some areas are still finding it hard to get vaccinated or even find out how to get shots. Yul Ejnes, MD, an internist and partner in Coastal Medical, an independent medical group based in Cranston, R.I., said in an interview that he and his practice staff haven’t been vaccinated, while the staffs of local hospitals have received their shots.

In response to repeated inquiries from his group, he said, the state health department recently said independent practice staffs will start getting vaccinated the week of Jan. 25.

Dr. Ejnes said he understood why hospital personnel went first: Hospitals have the necessary infrastructure, “and the staff in the emergency department and the ICU are caring for the sickest of the sick.”

For primary care doctors like himself who don’t work for the hospital, he said, “I don’t think an infrastructure to get us the vaccine in a timely manner was developed – or if it was developed, it hasn’t been communicated to us.”

Nevertheless, Dr. Ejnes stressed that primary care physicians in the community are just as vulnerable to the coronavirus as hospital clinicians. “We’re seeing patients who have COVID but don’t know they have it. I’m seeing 15 patients a day, and we screen them – as everyone else does – for symptoms and contact and travel, and check their temp,” he said. “But not a day goes by that one of the clinicians in this office doesn’t get a phone call from a patient who was seen a day or 2 earlier to tell them it turns out they were COVID positive. I’m spending 15 minutes in a 100–sq ft room with a patient for a routine visit. And as much as we’re masking and gloving and wearing eye protection, I wouldn’t consider us to be at low risk, especially with the high prevalence of disease.”

In some other states, the situation seems to be improving. Ada Stewart, MD, president of the American Academy of Family Physicians, said that she and her colleagues in a community health center in Columbia, S.C., are in the process of being vaccinated. She got her own shot Jan. 6 at a local hospital.

Her clinic’s staff hadn’t been vaccinated earlier, she said, because nobody in the practice knew the contact person at the hospital who could help access the vaccine doses. Other independent practices in her state are now getting vaccinated, she said, after Gov. Henry McMaster of South Carolina ordered that all health care providers in the top priority category be inoculated by Jan. 15. “At this point, the issues have been diminished.”

However, Dr. Stewart added, independent doctors in some states are still unable to get their shots. AAFP state chapters, as well as the national organization, are trying to persuade governors to ensure all of these physicians are vaccinated. “We’re trying to make sure that the voices of physicians not affiliated with health systems are being heard,” she said.
 

Lucky shot for doctor

David Boles, DO, a family doctor in Clarksville, Tenn., was able to get his first dose of vaccine just before Christmas, he said in an interview, because he was medical director of a hospice that had received vaccine doses for first responders. When some firefighters and police officers failed to show up for their appointments, the hospice called him and said he had 45 minutes to get to the site if he wanted to be vaccinated.

In early January, his colleagues and staff were also vaccinated, he said, after they were notified of their eligibility as frontline health care workers.

Dr. Boles agreed with Dr. Ejnes that community physicians and nurses are as much at risk as hospital clinicians, except for those intubating patients in the ICU. They may be even more vulnerable, he added, because they have less personal protective equipment than hospital doctors and nurses.

Jennifer Brull, MD, a family physician in Plainville, Kan., said there have been plenty of COVID-19 cases in her small rural community, and the local critical access hospital nearly ran out of beds at one point. Through a collaborative relationship among her clinic (the lone one in the area), the hospital, and the county health department, nearly every frontline health care worker has been vaccinated, and most clinicians in her group have gotten their second doses.

Both the hospital and the health department received vaccine supplies, she said, and everyone in the high-priority category was offered shots. So far, about 170 health care workers have been vaccinated, and only a few declined. More than 300 other people – most of them essential non–health care workers and people older than 65 – have signed up for the next round of shots.
 

Expanding vaccination effort

Dr. Brull’s practice is the exception among private medical groups around the country. Mr. Gilberg said the MGMA is “concerned that independent practices are playing second fiddle because they’ve been left behind.” Physicians and patient-facing staff in private groups should be getting vaccinated before hospital information technology workers and other non–patient-facing staffers.

Medical practices also can and should play a much bigger role in the overall vaccination effort. Mr. Gilberg has spoken to leaders of several large primary care groups “that have the freezers [for vaccines] and the capacity but haven’t been folded into the distribution plan, especially if they’re not part of the hospital system.”

While hospitals have the storage, he said, they’re not set up to distribute vaccines throughout their communities. “Most health care in this country is delivered outside of the hospital setting. That’s how you’re going to get people vaccinated.”

Ironically, he added, “the same PCPs that are having trouble getting themselves and their staffs vaccinated would be the physicians who could help with vaccine distribution.”

Dr. Brull’s clinic stands ready to help the hospital and health department vaccinate the local population. When sufficient vaccine supplies arrive, she said, she envisioned the doctors and staff administering 200-400 shots per day on Saturdays or weekends.

Dr. Brull was the exception – the other physicians interviewed hadn’t been invited to participate in vaccination efforts.

Dr. Ejnes said his group is capable of vaccinating its patients if it uses the Moderna vaccine, which doesn’t require a super-cold freezer. There are logistical challenges, including social distancing and finding space to observe vaccinated patients for 15 minutes after their shots, he noted. “We’re ready and willing, but realistic about how much we’ll be able to do in this effort.”

The fact that doctors haven’t been enlisted yet in this campaign speaks volumes about “the neglect of the public health infrastructure,” Dr. Ejnes said. “We’re not mobilizing as quickly as we should.”
 

Alternative routes

Dr. Boles’ group has a refrigerator for pediatric vaccines, which could be used to store the Moderna vaccine, he noted. Shots could be administered to patients in their cars in the parking lot, and they could wait for a while afterward until a nurse came out to verify they were okay.

Mass vaccination sites might also be deployed, as Los Angeles is doing with Dodger Stadium, and physicians could take shifts there in their spare time, Dr. Boles said. But for right now, he views pharmacies as the primary venues for community vaccination.

Of course, the number of pharmacists and pharmacy-employed advanced practice nurses is tiny, compared with the number of primary care doctors, mid-level practitioners, and nurses in ambulatory care practices. Moreover, Mr. Gilberg said, practices know from their electronic health records which patients are most at risk and should be vaccinated first. “Walgreens and CVS don’t know that.”

Physicians should also take the lead in vaccinations because of their patient relationships, he noted. “They can help educate [vaccine-hesitant] patients on why it’s important and dispel some of the rumors and the misinformation that has been politicized. That’s why we should engage physicians in an outpatient setting. And we have to vaccinate them and their staffs. Otherwise, we’re never going to get this rollout underway.”

Dr. Stewart agreed. “We are really the foundation of how we’re going to accomplish this. Most folks are seen by a primary care physician. We touch millions of lives,” she said. “We’re part of the community. Our patients trust us. We’re out there doing it already. We’re doing prevention, giving flu shots, and we’re trying to encourage people to get the COVID vaccine.”

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

The incoming Biden administration must formulate an effective national strategy for the COVID-19 pandemic, Susan R. Bailey, MD, president of the American Medical Association (AMA), said in a speech delivered Jan. 12 at the National Press Club in Washington.

Dr. Bailey noted that America’s fight against the pandemic is in a critical phase, as evidenced by the escalation in cases, hospitalizations, and deaths in recent weeks. Emergency departments and ICUs are overwhelmed; many frontline clinicians are burned out; and the state- and local-level mechanisms for vaccine distribution have been slow and inconsistent, she said.

“The most important lesson for this moment, and for the year ahead, is that leaving state and local officials to shoulder this burden alone without adequate support from the federal government is not going to work,” Dr. Bailey emphasized.

She called on the Biden administration, which takes over on Jan. 20, to “provide states and local jurisdictions with additional resources, guidance, and support to enable rapid distribution and administration of vaccines.”

In addition, she said, the incoming administration needs to develop a more robust, national strategy for continued COVID-19 testing and PPE production “by tapping into the full powers of the Defense Production Act.”
 

Biden vaccine distribution policy

In a question-and-answer period following her speech, however, Dr. Bailey said she opposed the president-elect’s decision to release nearly all available vaccine supplies immediately, rather than hold back some doses for the second shots that the Pfizer and Moderna vaccines require. On Jan. 12, the Trump administration announced that it plans to do the same thing.

“We’re a little bit concerned about the announcement that [the Department of Health and Human Services] will not hold back vaccine doses to make sure that everyone who’s gotten their first dose will have a second dose in reserve,” Dr. Bailey said. “We don’t have adequate data to tell us that one dose is sufficient – we don’t think it is – and how long you can wait for the second dose without losing the benefits of the first dose.”

She added that it’s not recommended that people mix the two vaccines in the first and second doses. “Since the Pfizer vaccine has such rigid storage requirements, I want to make sure there’s plenty of vaccine for frontline health care workers who got the Pfizer vaccine because it was the first one to come out in December. I want to make sure they get their second dose on time and [do] not have to wait.”

Dr. Bailey said she hoped there will be plenty of vaccine supply. But she suggested that state and local health authorities be in communication with the federal government about whether there will be enough vaccine to guarantee people can get both doses.
 

Bolstering public health

In her speech, Dr. Bailey outlined five areas in which steps should be taken to improve the health system so that it isn’t overwhelmed the next time the United States has a public health crisis:

• Restore trust in science and science-based decision making. Make sure that scientific institutions such as the Centers for Disease Control and Prevention and the Food and Drug Administration are “free from political pressure, and that their actions are guided by the best available scientific evidence.”
• Ensure that the health system provides all Americans with affordable access to comprehensive health care. Dr. Bailey wasn’t talking about Medicare for All; she suggested that perhaps there be a second enrollment period for the Affordable Care Act’s individual insurance exchanges.
• Work to remove health care inequities that have hurt communities of color, who have been disproportionately impacted by the pandemic. She referred to a recent AMA  that recognized racism as a public health threat.
• Improve public health domestically and globally. Among other things, she noted, the public health infrastructure needs to be revitalized after “decades of disinvestment and neglect,” which has contributed to the slow vaccine rollout.
• Recognize the global health community and restore America’s leadership in global efforts to combat disease, which are critical to preventing future threats. She praised President-Elect Biden for his promise that the United States will rejoin the World Health Organization.

At several points in her presentation, Dr. Bailey rejected political interference with science and health care. Among other things, she said public health could be improved by protecting the doctor-patient relationship from political interference.

Answering a question about how to separate politics from the pandemic, she replied, “The key is in sticking to the science and listening to our public health authorities. They all have to deliver the same message. Also, leaders at all levels, including in our communities, our schools, churches and college campuses, should wear masks and socially distance. This isn’t about anything other than the desire to get out of the pandemic and get our country on the right track again. Masks shouldn’t be political. Going back to school shouldn’t be political. Taking a certain medication or not shouldn’t be political. We need to stick to the science and listen to our public health authorities. That’s the quickest way out.”

Asked when she thought that life might get back to normal again in the United States, Dr. Bailey said a lot depends on the extent of vaccine uptake and how much self-discipline people exhibit in following public health advice. “I think we’re looking at the end of this year. I’m hopeful that by fall, things will have opened up quite a bit as the Venn diagrams of those who’ve gotten vaccines grow larger.”

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

The incoming Biden administration must formulate an effective national strategy for the COVID-19 pandemic, Susan R. Bailey, MD, president of the American Medical Association (AMA), said in a speech delivered Jan. 12 at the National Press Club in Washington.

Dr. Bailey noted that America’s fight against the pandemic is in a critical phase, as evidenced by the escalation in cases, hospitalizations, and deaths in recent weeks. Emergency departments and ICUs are overwhelmed; many frontline clinicians are burned out; and the state- and local-level mechanisms for vaccine distribution have been slow and inconsistent, she said.

“The most important lesson for this moment, and for the year ahead, is that leaving state and local officials to shoulder this burden alone without adequate support from the federal government is not going to work,” Dr. Bailey emphasized.

She called on the Biden administration, which takes over on Jan. 20, to “provide states and local jurisdictions with additional resources, guidance, and support to enable rapid distribution and administration of vaccines.”

In addition, she said, the incoming administration needs to develop a more robust, national strategy for continued COVID-19 testing and PPE production “by tapping into the full powers of the Defense Production Act.”
 

Biden vaccine distribution policy

In a question-and-answer period following her speech, however, Dr. Bailey said she opposed the president-elect’s decision to release nearly all available vaccine supplies immediately, rather than hold back some doses for the second shots that the Pfizer and Moderna vaccines require. On Jan. 12, the Trump administration announced that it plans to do the same thing.

“We’re a little bit concerned about the announcement that [the Department of Health and Human Services] will not hold back vaccine doses to make sure that everyone who’s gotten their first dose will have a second dose in reserve,” Dr. Bailey said. “We don’t have adequate data to tell us that one dose is sufficient – we don’t think it is – and how long you can wait for the second dose without losing the benefits of the first dose.”

She added that it’s not recommended that people mix the two vaccines in the first and second doses. “Since the Pfizer vaccine has such rigid storage requirements, I want to make sure there’s plenty of vaccine for frontline health care workers who got the Pfizer vaccine because it was the first one to come out in December. I want to make sure they get their second dose on time and [do] not have to wait.”

Dr. Bailey said she hoped there will be plenty of vaccine supply. But she suggested that state and local health authorities be in communication with the federal government about whether there will be enough vaccine to guarantee people can get both doses.
 

Bolstering public health

In her speech, Dr. Bailey outlined five areas in which steps should be taken to improve the health system so that it isn’t overwhelmed the next time the United States has a public health crisis:

• Restore trust in science and science-based decision making. Make sure that scientific institutions such as the Centers for Disease Control and Prevention and the Food and Drug Administration are “free from political pressure, and that their actions are guided by the best available scientific evidence.”
• Ensure that the health system provides all Americans with affordable access to comprehensive health care. Dr. Bailey wasn’t talking about Medicare for All; she suggested that perhaps there be a second enrollment period for the Affordable Care Act’s individual insurance exchanges.
• Work to remove health care inequities that have hurt communities of color, who have been disproportionately impacted by the pandemic. She referred to a recent AMA  that recognized racism as a public health threat.
• Improve public health domestically and globally. Among other things, she noted, the public health infrastructure needs to be revitalized after “decades of disinvestment and neglect,” which has contributed to the slow vaccine rollout.
• Recognize the global health community and restore America’s leadership in global efforts to combat disease, which are critical to preventing future threats. She praised President-Elect Biden for his promise that the United States will rejoin the World Health Organization.

At several points in her presentation, Dr. Bailey rejected political interference with science and health care. Among other things, she said public health could be improved by protecting the doctor-patient relationship from political interference.

Answering a question about how to separate politics from the pandemic, she replied, “The key is in sticking to the science and listening to our public health authorities. They all have to deliver the same message. Also, leaders at all levels, including in our communities, our schools, churches and college campuses, should wear masks and socially distance. This isn’t about anything other than the desire to get out of the pandemic and get our country on the right track again. Masks shouldn’t be political. Going back to school shouldn’t be political. Taking a certain medication or not shouldn’t be political. We need to stick to the science and listen to our public health authorities. That’s the quickest way out.”

Asked when she thought that life might get back to normal again in the United States, Dr. Bailey said a lot depends on the extent of vaccine uptake and how much self-discipline people exhibit in following public health advice. “I think we’re looking at the end of this year. I’m hopeful that by fall, things will have opened up quite a bit as the Venn diagrams of those who’ve gotten vaccines grow larger.”

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

The incoming Biden administration must formulate an effective national strategy for the COVID-19 pandemic, Susan R. Bailey, MD, president of the American Medical Association (AMA), said in a speech delivered Jan. 12 at the National Press Club in Washington.

Dr. Bailey noted that America’s fight against the pandemic is in a critical phase, as evidenced by the escalation in cases, hospitalizations, and deaths in recent weeks. Emergency departments and ICUs are overwhelmed; many frontline clinicians are burned out; and the state- and local-level mechanisms for vaccine distribution have been slow and inconsistent, she said.

“The most important lesson for this moment, and for the year ahead, is that leaving state and local officials to shoulder this burden alone without adequate support from the federal government is not going to work,” Dr. Bailey emphasized.

She called on the Biden administration, which takes over on Jan. 20, to “provide states and local jurisdictions with additional resources, guidance, and support to enable rapid distribution and administration of vaccines.”

In addition, she said, the incoming administration needs to develop a more robust, national strategy for continued COVID-19 testing and PPE production “by tapping into the full powers of the Defense Production Act.”
 

Biden vaccine distribution policy

In a question-and-answer period following her speech, however, Dr. Bailey said she opposed the president-elect’s decision to release nearly all available vaccine supplies immediately, rather than hold back some doses for the second shots that the Pfizer and Moderna vaccines require. On Jan. 12, the Trump administration announced that it plans to do the same thing.

“We’re a little bit concerned about the announcement that [the Department of Health and Human Services] will not hold back vaccine doses to make sure that everyone who’s gotten their first dose will have a second dose in reserve,” Dr. Bailey said. “We don’t have adequate data to tell us that one dose is sufficient – we don’t think it is – and how long you can wait for the second dose without losing the benefits of the first dose.”

She added that it’s not recommended that people mix the two vaccines in the first and second doses. “Since the Pfizer vaccine has such rigid storage requirements, I want to make sure there’s plenty of vaccine for frontline health care workers who got the Pfizer vaccine because it was the first one to come out in December. I want to make sure they get their second dose on time and [do] not have to wait.”

Dr. Bailey said she hoped there will be plenty of vaccine supply. But she suggested that state and local health authorities be in communication with the federal government about whether there will be enough vaccine to guarantee people can get both doses.
 

Bolstering public health

In her speech, Dr. Bailey outlined five areas in which steps should be taken to improve the health system so that it isn’t overwhelmed the next time the United States has a public health crisis:

• Restore trust in science and science-based decision making. Make sure that scientific institutions such as the Centers for Disease Control and Prevention and the Food and Drug Administration are “free from political pressure, and that their actions are guided by the best available scientific evidence.”
• Ensure that the health system provides all Americans with affordable access to comprehensive health care. Dr. Bailey wasn’t talking about Medicare for All; she suggested that perhaps there be a second enrollment period for the Affordable Care Act’s individual insurance exchanges.
• Work to remove health care inequities that have hurt communities of color, who have been disproportionately impacted by the pandemic. She referred to a recent AMA  that recognized racism as a public health threat.
• Improve public health domestically and globally. Among other things, she noted, the public health infrastructure needs to be revitalized after “decades of disinvestment and neglect,” which has contributed to the slow vaccine rollout.
• Recognize the global health community and restore America’s leadership in global efforts to combat disease, which are critical to preventing future threats. She praised President-Elect Biden for his promise that the United States will rejoin the World Health Organization.

At several points in her presentation, Dr. Bailey rejected political interference with science and health care. Among other things, she said public health could be improved by protecting the doctor-patient relationship from political interference.

Answering a question about how to separate politics from the pandemic, she replied, “The key is in sticking to the science and listening to our public health authorities. They all have to deliver the same message. Also, leaders at all levels, including in our communities, our schools, churches and college campuses, should wear masks and socially distance. This isn’t about anything other than the desire to get out of the pandemic and get our country on the right track again. Masks shouldn’t be political. Going back to school shouldn’t be political. Taking a certain medication or not shouldn’t be political. We need to stick to the science and listen to our public health authorities. That’s the quickest way out.”

Asked when she thought that life might get back to normal again in the United States, Dr. Bailey said a lot depends on the extent of vaccine uptake and how much self-discipline people exhibit in following public health advice. “I think we’re looking at the end of this year. I’m hopeful that by fall, things will have opened up quite a bit as the Venn diagrams of those who’ve gotten vaccines grow larger.”

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

Federal health officials are urging states to vaccinate all Americans over age 65 and those aged 16-64 who have a documented underlying health condition that makes them more vulnerable to COVID-19.

U.S. Department of Health and Human Services (HHS) Secretary Alex Azar and Centers for Disease Control and Prevention Director Robert Redfield, MD, made the recommendation in a briefing with reporters on Jan. 12, saying that the current vaccine supply was sufficient to meet demand for the next phase of immunization as recommended by the CDC’s Advisory Committee on Immunization Practices.

“We are ready for a transition that we outlined last September in the playbook we sent to states,” Mr. Azar said. Both he and U.S. Army General Gustave F. Perna, chief operations officer for Operation Warp Speed, said that confidence in the distribution system had led to the decision to urge wider access.

The federal government will also increase the number of sites eligible to receive vaccine – including some 13,000 federally qualified community health centers – and will not keep doses in reserve as insurance against issues that might prevent people from receiving a second dose on a timely basis. 

“We don’t need to hold back reserve doses,” Mr. Azar said, noting that if there were any “glitches in production” the federal government would move to fulfill obligations for second doses first and delay initial doses.
 

Azar: Use it or lose it

In a move that is sure to generate pushback, Mr. Azar said that states that don’t quickly administer vaccines will receive fewer doses in the future. That policy will not go into effect until later in February, which leaves open the possibility that it could be reversed by the incoming Biden administration.

“We have too much vaccine sitting in freezers at hospitals with hospitals not using it,” said Mr. Azar, who also blamed the slow administration process on a reporting lag and states being what he called “overly prescriptive” in who has been eligible to receive a shot.

“I would rather have people working to get appointments to get vaccinated than having vaccine going to waste sitting in freezers,” he told reporters.

Mr. Azar had already been pushing for broader vaccination, telling states to do so in an Operation Warp Speed briefing on Jan. 6. At that briefing, he also said that the federal government would be stepping up vaccination through an “early launch” of a federal partnership with 19 pharmacy chains, which will let states allocate vaccines directly to some 40,000 pharmacy sites.

Gen. Perna said during the Jan. 12 briefing that the aim is to further expand that to some 70,000 locations total.

The CDC reported that as of Jan. 11 some 25.4 million doses have been distributed, with 8.9 million administered. An additional 4.2 million doses were distributed to long-term care facilities, and 937,000 residents and staff have received a dose.
 

“Pace of administration”

Alaska, Connecticut, North Dakota, South Dakota, the District of Columbia, West Virginia, and the Northern Mariana Islands have administered the most vaccines per capita, according to the CDC. But even these locations have immunized only 4%-5% of their populations, the New York Times reports. At the bottom: Alabama, Arizona, Arkansas, Georgia, Mississippi, and South Carolina.

The federal government can encourage but not require states to move on to new phases of vaccination.

“States ultimately determine how they will proceed with vaccination,” said Marcus Plescia, MD, MPH, chief medical officer for the Association of State and Territorial Health Officials. “Most will be cautious about assuring there are doses for those needing a second dose,” he said in an interview.

Dr. Plescia said that ensuring a second dose is available is especially important for health care workers “who need to be confident that they are protected and not inadvertently transmitting the disease themselves.”

He added that “once we reach a steady state of supply and administration, the rate-limiting factor will be supply of vaccine.”

That supply could now be threatened if states don’t comply with a just-announced federal action that will change how doses are allocated.

Beginning in late February, vaccine allocations to states will be based on “the pace of administration reported by states,” and the size of the 65-and-older population, said Mr. Azar, who has previously criticized New York Governor Andrew Cuomo for fining hospitals that didn’t use up vaccine supply within a week.

“This new system gives states a strong incentive to ensure that all vaccinations are being promptly reported, which they currently are not,” he said.

Currently, allocations are based on a state’s or territory’s population.

Prepandemic, states were required to report vaccinations within 30 days. Since COVID-19 vaccines became available, the CDC has required reporting of shots within 72 hours.

Dr. Redfield said the requirement has caused some difficulty, and that the CDC is investigating why some states have reported using only 15% of doses while others have used 80%.

States have been scrambling to ramp up vaccinations.

Just ahead of the federal briefing, Gov. Cuomo tweeted that New York would be opening up vaccinations to anyone older than 65.

The Associated Press is reporting that some states have started mass vaccination sites.

Arizona has begun operating a 24/7 appointment-only vaccination program at State Farm Stadium outside of Phoenix, with the aim of immunizing 6,000 people each day, according to local radio station KJZZ.

California and Florida have also taken steps to use stadiums, while Michigan, New Jersey, New York, and Texas will use convention centers and fairgrounds, Axios has reported.

In Florida, Palm Beach County Health Director Alina Alonso, MD, told county commissioners on Jan. 12 that there isn’t enough vaccine to meet demand, WPTV reported. “We need to realize that there’s a shortage of vaccine. So it’s not the plan, it’s not our ability to do it. It’s simply supply and demand at this point,” Dr. Alonso said, according to the TV station report.

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

Federal health officials are urging states to vaccinate all Americans over age 65 and those aged 16-64 who have a documented underlying health condition that makes them more vulnerable to COVID-19.

U.S. Department of Health and Human Services (HHS) Secretary Alex Azar and Centers for Disease Control and Prevention Director Robert Redfield, MD, made the recommendation in a briefing with reporters on Jan. 12, saying that the current vaccine supply was sufficient to meet demand for the next phase of immunization as recommended by the CDC’s Advisory Committee on Immunization Practices.

“We are ready for a transition that we outlined last September in the playbook we sent to states,” Mr. Azar said. Both he and U.S. Army General Gustave F. Perna, chief operations officer for Operation Warp Speed, said that confidence in the distribution system had led to the decision to urge wider access.

The federal government will also increase the number of sites eligible to receive vaccine – including some 13,000 federally qualified community health centers – and will not keep doses in reserve as insurance against issues that might prevent people from receiving a second dose on a timely basis. 

“We don’t need to hold back reserve doses,” Mr. Azar said, noting that if there were any “glitches in production” the federal government would move to fulfill obligations for second doses first and delay initial doses.
 

Azar: Use it or lose it

In a move that is sure to generate pushback, Mr. Azar said that states that don’t quickly administer vaccines will receive fewer doses in the future. That policy will not go into effect until later in February, which leaves open the possibility that it could be reversed by the incoming Biden administration.

“We have too much vaccine sitting in freezers at hospitals with hospitals not using it,” said Mr. Azar, who also blamed the slow administration process on a reporting lag and states being what he called “overly prescriptive” in who has been eligible to receive a shot.

“I would rather have people working to get appointments to get vaccinated than having vaccine going to waste sitting in freezers,” he told reporters.

Mr. Azar had already been pushing for broader vaccination, telling states to do so in an Operation Warp Speed briefing on Jan. 6. At that briefing, he also said that the federal government would be stepping up vaccination through an “early launch” of a federal partnership with 19 pharmacy chains, which will let states allocate vaccines directly to some 40,000 pharmacy sites.

Gen. Perna said during the Jan. 12 briefing that the aim is to further expand that to some 70,000 locations total.

The CDC reported that as of Jan. 11 some 25.4 million doses have been distributed, with 8.9 million administered. An additional 4.2 million doses were distributed to long-term care facilities, and 937,000 residents and staff have received a dose.
 

“Pace of administration”

Alaska, Connecticut, North Dakota, South Dakota, the District of Columbia, West Virginia, and the Northern Mariana Islands have administered the most vaccines per capita, according to the CDC. But even these locations have immunized only 4%-5% of their populations, the New York Times reports. At the bottom: Alabama, Arizona, Arkansas, Georgia, Mississippi, and South Carolina.

The federal government can encourage but not require states to move on to new phases of vaccination.

“States ultimately determine how they will proceed with vaccination,” said Marcus Plescia, MD, MPH, chief medical officer for the Association of State and Territorial Health Officials. “Most will be cautious about assuring there are doses for those needing a second dose,” he said in an interview.

Dr. Plescia said that ensuring a second dose is available is especially important for health care workers “who need to be confident that they are protected and not inadvertently transmitting the disease themselves.”

He added that “once we reach a steady state of supply and administration, the rate-limiting factor will be supply of vaccine.”

That supply could now be threatened if states don’t comply with a just-announced federal action that will change how doses are allocated.

Beginning in late February, vaccine allocations to states will be based on “the pace of administration reported by states,” and the size of the 65-and-older population, said Mr. Azar, who has previously criticized New York Governor Andrew Cuomo for fining hospitals that didn’t use up vaccine supply within a week.

“This new system gives states a strong incentive to ensure that all vaccinations are being promptly reported, which they currently are not,” he said.

Currently, allocations are based on a state’s or territory’s population.

Prepandemic, states were required to report vaccinations within 30 days. Since COVID-19 vaccines became available, the CDC has required reporting of shots within 72 hours.

Dr. Redfield said the requirement has caused some difficulty, and that the CDC is investigating why some states have reported using only 15% of doses while others have used 80%.

States have been scrambling to ramp up vaccinations.

Just ahead of the federal briefing, Gov. Cuomo tweeted that New York would be opening up vaccinations to anyone older than 65.

The Associated Press is reporting that some states have started mass vaccination sites.

Arizona has begun operating a 24/7 appointment-only vaccination program at State Farm Stadium outside of Phoenix, with the aim of immunizing 6,000 people each day, according to local radio station KJZZ.

California and Florida have also taken steps to use stadiums, while Michigan, New Jersey, New York, and Texas will use convention centers and fairgrounds, Axios has reported.

In Florida, Palm Beach County Health Director Alina Alonso, MD, told county commissioners on Jan. 12 that there isn’t enough vaccine to meet demand, WPTV reported. “We need to realize that there’s a shortage of vaccine. So it’s not the plan, it’s not our ability to do it. It’s simply supply and demand at this point,” Dr. Alonso said, according to the TV station report.

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

Federal health officials are urging states to vaccinate all Americans over age 65 and those aged 16-64 who have a documented underlying health condition that makes them more vulnerable to COVID-19.

U.S. Department of Health and Human Services (HHS) Secretary Alex Azar and Centers for Disease Control and Prevention Director Robert Redfield, MD, made the recommendation in a briefing with reporters on Jan. 12, saying that the current vaccine supply was sufficient to meet demand for the next phase of immunization as recommended by the CDC’s Advisory Committee on Immunization Practices.

“We are ready for a transition that we outlined last September in the playbook we sent to states,” Mr. Azar said. Both he and U.S. Army General Gustave F. Perna, chief operations officer for Operation Warp Speed, said that confidence in the distribution system had led to the decision to urge wider access.

The federal government will also increase the number of sites eligible to receive vaccine – including some 13,000 federally qualified community health centers – and will not keep doses in reserve as insurance against issues that might prevent people from receiving a second dose on a timely basis. 

“We don’t need to hold back reserve doses,” Mr. Azar said, noting that if there were any “glitches in production” the federal government would move to fulfill obligations for second doses first and delay initial doses.
 

Azar: Use it or lose it

In a move that is sure to generate pushback, Mr. Azar said that states that don’t quickly administer vaccines will receive fewer doses in the future. That policy will not go into effect until later in February, which leaves open the possibility that it could be reversed by the incoming Biden administration.

“We have too much vaccine sitting in freezers at hospitals with hospitals not using it,” said Mr. Azar, who also blamed the slow administration process on a reporting lag and states being what he called “overly prescriptive” in who has been eligible to receive a shot.

“I would rather have people working to get appointments to get vaccinated than having vaccine going to waste sitting in freezers,” he told reporters.

Mr. Azar had already been pushing for broader vaccination, telling states to do so in an Operation Warp Speed briefing on Jan. 6. At that briefing, he also said that the federal government would be stepping up vaccination through an “early launch” of a federal partnership with 19 pharmacy chains, which will let states allocate vaccines directly to some 40,000 pharmacy sites.

Gen. Perna said during the Jan. 12 briefing that the aim is to further expand that to some 70,000 locations total.

The CDC reported that as of Jan. 11 some 25.4 million doses have been distributed, with 8.9 million administered. An additional 4.2 million doses were distributed to long-term care facilities, and 937,000 residents and staff have received a dose.
 

“Pace of administration”

Alaska, Connecticut, North Dakota, South Dakota, the District of Columbia, West Virginia, and the Northern Mariana Islands have administered the most vaccines per capita, according to the CDC. But even these locations have immunized only 4%-5% of their populations, the New York Times reports. At the bottom: Alabama, Arizona, Arkansas, Georgia, Mississippi, and South Carolina.

The federal government can encourage but not require states to move on to new phases of vaccination.

“States ultimately determine how they will proceed with vaccination,” said Marcus Plescia, MD, MPH, chief medical officer for the Association of State and Territorial Health Officials. “Most will be cautious about assuring there are doses for those needing a second dose,” he said in an interview.

Dr. Plescia said that ensuring a second dose is available is especially important for health care workers “who need to be confident that they are protected and not inadvertently transmitting the disease themselves.”

He added that “once we reach a steady state of supply and administration, the rate-limiting factor will be supply of vaccine.”

That supply could now be threatened if states don’t comply with a just-announced federal action that will change how doses are allocated.

Beginning in late February, vaccine allocations to states will be based on “the pace of administration reported by states,” and the size of the 65-and-older population, said Mr. Azar, who has previously criticized New York Governor Andrew Cuomo for fining hospitals that didn’t use up vaccine supply within a week.

“This new system gives states a strong incentive to ensure that all vaccinations are being promptly reported, which they currently are not,” he said.

Currently, allocations are based on a state’s or territory’s population.

Prepandemic, states were required to report vaccinations within 30 days. Since COVID-19 vaccines became available, the CDC has required reporting of shots within 72 hours.

Dr. Redfield said the requirement has caused some difficulty, and that the CDC is investigating why some states have reported using only 15% of doses while others have used 80%.

States have been scrambling to ramp up vaccinations.

Just ahead of the federal briefing, Gov. Cuomo tweeted that New York would be opening up vaccinations to anyone older than 65.

The Associated Press is reporting that some states have started mass vaccination sites.

Arizona has begun operating a 24/7 appointment-only vaccination program at State Farm Stadium outside of Phoenix, with the aim of immunizing 6,000 people each day, according to local radio station KJZZ.

California and Florida have also taken steps to use stadiums, while Michigan, New Jersey, New York, and Texas will use convention centers and fairgrounds, Axios has reported.

In Florida, Palm Beach County Health Director Alina Alonso, MD, told county commissioners on Jan. 12 that there isn’t enough vaccine to meet demand, WPTV reported. “We need to realize that there’s a shortage of vaccine. So it’s not the plan, it’s not our ability to do it. It’s simply supply and demand at this point,” Dr. Alonso said, according to the TV station report.

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

The United States has allocated more than 641,000 monoclonal antibody treatments for outpatients to ease pressure on strained hospitals, but officials from Operation Warp Speed report that more than half of that reserve sits unused as clinicians grapple with best practices.

There are space and personnel limitations in hospitals right now, Janet Woodcock, MD, therapeutics lead on Operation Warp Speed, acknowledges in an interview with this news organization. “Special areas and procedures must be set up.” And the operation is in the process of broadening availability beyond hospitals, she points out.

But for frontline clinicians, questions about treatment efficacy and the logistics of administering intravenous drugs to infectious outpatients loom large.

More than 50 monoclonal antibody products that target SARS-CoV-2 are now in development. The U.S. Food and Drug Administration has already issued Emergency Use Authorization (EUA) for two such drugs on the basis of phase 2 trial data – bamlanivimab, made by Eli Lilly, and a cocktail of casirivimab plus imdevimab, made by Regeneron – and another two-antibody cocktail from AstraZeneca, AZD7442, has started phase 3 clinical trials. The Regeneron combination was used to treat President Donald Trump when he contracted COVID-19 in October.

Monoclonal antibody drugs are based on the natural antibodies that the body uses to fight infections. They work by binding to a specific target and then blocking its action or flagging it for destruction by other parts of the immune system. Both bamlanivimab and the casirivimab plus imdevimab combination target the spike protein of the virus and stop it from attaching to and entering human cells.
 

Targeting the spike protein out of the hospital

The antibody drugs covered by EUAs do not cure COVID-19, but they have been shown to reduce hospitalizations and visits to the emergency department for patients at high risk for disease progression. They are approved to treat patients older than 12 years with mild to moderate COVID-19 who are at high risk of progressing to severe disease or hospitalization. They are not authorized for use in patients who have been hospitalized or who are on ventilators. The hope is that antibody drugs will reduce the number of severe cases of COVID-19 and ease pressure on overstretched hospitals.

Most COVID-19 patients are outpatients, so we need something to keep them from getting worse.

This is important because it targets the greatest need in COVID-19 therapeutics, says Rajesh Gandhi, MD, an infectious disease physician at Harvard Medical School in Boston, who is a member of two panels evaluating COVID-19 treatments: one for the Infectious Disease Society of America and the other for the National Institutes of Health. “Up to now, most of the focus has been on hospitalized patients,” he says, but “most COVID-19 patients are outpatients, so we need something to keep them from getting worse.”

Both panels have said that, despite the EUAs, more evidence is needed to be sure of the efficacy of the drugs and to determine which patients will benefit the most from them.

These aren’t the mature data from drug development that guideline groups are accustomed to working with, Dr. Woodcock points out. “But this is an emergency and the data taken as a whole are pretty convincing,” she says. “As I look at the totality of the evidence, monoclonal antibodies will have a big effect in keeping people out of the hospital and helping them recover faster.”

High-risk patients are eligible for treatment, especially those older than 65 years and those with comorbidities who are younger. Access to the drugs is increasing for clinicians who are able to infuse safely or work with a site that will.

In the Boston area, several hospitals, including Massachusetts General where Dr. Gandhi works, have set up infusion centers where newly diagnosed patients can get the antibody treatment if their doctor thinks it will benefit them. And Coram, a provider of at-home infusion therapy owned by the CVS pharmacy chain, is running a pilot program offering the Eli Lilly drug to people in seven cities – including Boston, Chicago, Los Angeles, and Tampa – and their surrounding communities with a physician referral.

Getting that referral could be tricky, however, for patients without a primary care physician or for those whose doctor isn’t already connected to one of the institutions providing the infusions. The hospitals are sending out communications on how patients and physicians can get the therapy, but Dr. Gandhi says that making information about access available should be a priority. The window for the effective treatment is small – the drugs appear to work best before patients begin to make their own antibodies, says Dr. Gandhi – so it’s vital that doctors act quickly if they have a patient who is eligible.

And rolling out the new therapies to patients around the world will be a major logistical undertaking.

The first hurdle will be making enough of them to go around. Case numbers are skyrocketing around the globe, and producing the drugs is a complex time- and labor-intensive process that requires specialized facilities. Antibodies are produced by cell lines in bioreactors, so a plant that churns out generic aspirin tablets can’t simply be converted into an antibody factory.

“These types of drugs are manufactured in a sterile injectables plant, which is different from a plant where oral solids are made,” says Kim Crabtree, senior director of pharma portfolio management for Henry Schein Medical, a medical supplies distributor. “Those are not as plentiful as a standard pill factory.”

The doses required are also relatively high – 1.2 g of each antibody in Regeneron’s cocktail – which will further strain production capacity. Leah Lipsich, PhD, vice president of strategic program direction at Regeneron, says the company is prepared for high demand and has been able to respond, thanks to its rapid development and manufacturing technology, known as VelociSuite, which allows it to rapidly scale-up from discovery to productions in weeks instead of months.

“We knew supply would be a huge problem for COVID-19, but because we had such confidence in our technology, we went immediately from research-scale to our largest-scale manufacturing,” she says. “We’ve been manufacturing our cocktail for months now.”

The company has also partnered with Roche, the biggest manufacturer and vendor of monoclonal antibodies in the world, to manufacture and supply the drugs. Once full manufacturing capacity is reached in 2021, the companies expect to produce at least 2 million doses a year.

Then there is the issue of getting the drugs from the factories to the places they will be used.

Antibodies are temperature sensitive and need to be refrigerated during transport and storage, so a cold-chain-compliant supply chain is required. Fortunately, they can be kept at standard refrigerator temperatures, ranging from 2° C to 8° C, rather than the ultra-low temperatures required by some COVID-19 vaccines.
 

Two million doses a year

Medical logistics companies have a lot of experience dealing with products like these and are well prepared to handle the new antibody drugs. “There are quite a few products like these on the market, and the supply chain is used to shipping them,” Ms. Crabtree says.

They will be shipped to distribution centers in refrigerated trucks, repacked into smaller lots that can sustain the correct temperature for 24 hours, and then sent to their final destination, often in something as simple as a Styrofoam cooler filled with dry ice.

The expected rise in demand shouldn’t be too much of an issue for distributors either, says Ms. Crabtree; they have built systems that can deal with short-term surges in volume. The annual flu vaccine, for example, involves shipping a lot of product in a very short time, usually from August to November. “The distribution system is used to seasonal variations and peaks in demand,” she says.

The next question is how the treatments will be administered. Although most patients who will receive monoclonal antibodies will be ambulatory and not hospitalized, the administration requires intravenous infusion. Hospitals, of course, have a lot of experience with intravenous drugs, but typically give them only to inpatients. Most other monoclonal antibody drugs – such as those for cancer and autoimmune disorders – are given in specialized suites in doctor’s offices or in stand-alone infusion clinics.

That means that the places best suited to treat COVID-19 patients with antibodies are those that regularly deal with people who are immunocompromised, and such patients should not be interacting with people who have an infectious disease. “How do we protect the staff and other patients?” Dr. Gandhi asks.
 

Protecting staff and other patients

This is not an insurmountable obstacle, he points out, but it is one that requires careful thought and planning to accommodate COVID-19 patients without unduly disrupting life-saving treatments for other patients. It might involve, for example, treating COVID-19 patients in sequestered parts of the clinic or at different times of day, with even greater attention paid to cleaning, he explains. “We now have many months of experience with infection control, so we know how to do this; it’s just a question of logistics.”

But even once all the details around manufacturing, transporting, and administering the drugs are sorted out, there is still the issue of how they will be distributed fairly and equitably.

Despite multiple companies working to produce an array of different antibody drugs, demand is still expected to exceed supply for many months. “With more than 200,000 new cases a day in the United States, there won’t be enough antibodies to treat all of the high-risk patients,” says Dr. Gandhi. “Most of us are worried that demand will far outstrip supply. People are talking about lotteries to determine who gets them.”

The Department of Health and Human Services will continue to distribute the drugs to states on the basis of their COVID-19 burdens, and the states will then decide how much to provide to each health care facility.

Although the HHS goal is to ensure that the drugs reach as many patients as possible, no matter where they live and regardless of their income, there are still concerns that larger facilities serving more affluent areas will end up being favored, if only because they are the ones best equipped to deal with the drugs right now.

“We are all aware that this has affected certain communities more, so we need to make sure that the drugs are used equitably and made available to the communities that were hardest hit,” says Dr. Gandhi. The ability to monitor drug distribution should be built into the rollout, so that institutions and governments will have some sense of whether they are being doled out evenly, he adds.

Equity in distribution will be an issue for the rest of the world as well. Currently, 80% of monoclonal antibodies are sold in Canada, Europe, and the United States; few, if any, are available in low- and middle-income countries. The treatments are expensive: the cost of producing one g of marketed monoclonal antibodies is between $95 and $200, which does not include the cost of R&D, packaging, shipping, or administration. The median price for antibody treatment not related to COVID-19 runs from $15,000 to $200,000 per year in the United States.

Regeneron’s Dr. Lipsich says that the company has not yet set a price for its antibody cocktail. The government paid $450 million for its 300,000 doses, but that price includes the costs of research, manufacturing, and distribution, so is not a useful indicator of the eventual per-dose price. “We’re not in a position to talk about how it will be priced yet, but we will do our best to make it affordable and accessible to all,” she says.

There are some projects underway to ensure that the drugs are made available in poorer countries. In April, the COVID-19 Therapeutics Accelerator – an initiative launched by the Bill & Melinda Gates Foundation, Wellcome, and Mastercard to speed-up the response to the global pandemic – reserved manufacturing capacity with Fujifilm Diosynth Biotechnologies in Denmark for future monoclonal antibody therapies that will supply low- and middle-income countries. In October, the initiative announced that Eli Lilly would use that reserved capacity to produce its antibody drug starting in April 2021.

In the meantime, Lilly will make some of its product manufactured in other facilities available to lower-income countries. To help keep costs down, the company’s collaborators have agreed to waive their royalties on antibodies distributed in low- and middle-income countries.

“Everyone is looking carefully at how the drugs are distributed to ensure all will get access,” said Dr. Lipsich.

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

The United States has allocated more than 641,000 monoclonal antibody treatments for outpatients to ease pressure on strained hospitals, but officials from Operation Warp Speed report that more than half of that reserve sits unused as clinicians grapple with best practices.

There are space and personnel limitations in hospitals right now, Janet Woodcock, MD, therapeutics lead on Operation Warp Speed, acknowledges in an interview with this news organization. “Special areas and procedures must be set up.” And the operation is in the process of broadening availability beyond hospitals, she points out.

But for frontline clinicians, questions about treatment efficacy and the logistics of administering intravenous drugs to infectious outpatients loom large.

More than 50 monoclonal antibody products that target SARS-CoV-2 are now in development. The U.S. Food and Drug Administration has already issued Emergency Use Authorization (EUA) for two such drugs on the basis of phase 2 trial data – bamlanivimab, made by Eli Lilly, and a cocktail of casirivimab plus imdevimab, made by Regeneron – and another two-antibody cocktail from AstraZeneca, AZD7442, has started phase 3 clinical trials. The Regeneron combination was used to treat President Donald Trump when he contracted COVID-19 in October.

Monoclonal antibody drugs are based on the natural antibodies that the body uses to fight infections. They work by binding to a specific target and then blocking its action or flagging it for destruction by other parts of the immune system. Both bamlanivimab and the casirivimab plus imdevimab combination target the spike protein of the virus and stop it from attaching to and entering human cells.
 

Targeting the spike protein out of the hospital

The antibody drugs covered by EUAs do not cure COVID-19, but they have been shown to reduce hospitalizations and visits to the emergency department for patients at high risk for disease progression. They are approved to treat patients older than 12 years with mild to moderate COVID-19 who are at high risk of progressing to severe disease or hospitalization. They are not authorized for use in patients who have been hospitalized or who are on ventilators. The hope is that antibody drugs will reduce the number of severe cases of COVID-19 and ease pressure on overstretched hospitals.

Most COVID-19 patients are outpatients, so we need something to keep them from getting worse.

This is important because it targets the greatest need in COVID-19 therapeutics, says Rajesh Gandhi, MD, an infectious disease physician at Harvard Medical School in Boston, who is a member of two panels evaluating COVID-19 treatments: one for the Infectious Disease Society of America and the other for the National Institutes of Health. “Up to now, most of the focus has been on hospitalized patients,” he says, but “most COVID-19 patients are outpatients, so we need something to keep them from getting worse.”

Both panels have said that, despite the EUAs, more evidence is needed to be sure of the efficacy of the drugs and to determine which patients will benefit the most from them.

These aren’t the mature data from drug development that guideline groups are accustomed to working with, Dr. Woodcock points out. “But this is an emergency and the data taken as a whole are pretty convincing,” she says. “As I look at the totality of the evidence, monoclonal antibodies will have a big effect in keeping people out of the hospital and helping them recover faster.”

High-risk patients are eligible for treatment, especially those older than 65 years and those with comorbidities who are younger. Access to the drugs is increasing for clinicians who are able to infuse safely or work with a site that will.

In the Boston area, several hospitals, including Massachusetts General where Dr. Gandhi works, have set up infusion centers where newly diagnosed patients can get the antibody treatment if their doctor thinks it will benefit them. And Coram, a provider of at-home infusion therapy owned by the CVS pharmacy chain, is running a pilot program offering the Eli Lilly drug to people in seven cities – including Boston, Chicago, Los Angeles, and Tampa – and their surrounding communities with a physician referral.

Getting that referral could be tricky, however, for patients without a primary care physician or for those whose doctor isn’t already connected to one of the institutions providing the infusions. The hospitals are sending out communications on how patients and physicians can get the therapy, but Dr. Gandhi says that making information about access available should be a priority. The window for the effective treatment is small – the drugs appear to work best before patients begin to make their own antibodies, says Dr. Gandhi – so it’s vital that doctors act quickly if they have a patient who is eligible.

And rolling out the new therapies to patients around the world will be a major logistical undertaking.

The first hurdle will be making enough of them to go around. Case numbers are skyrocketing around the globe, and producing the drugs is a complex time- and labor-intensive process that requires specialized facilities. Antibodies are produced by cell lines in bioreactors, so a plant that churns out generic aspirin tablets can’t simply be converted into an antibody factory.

“These types of drugs are manufactured in a sterile injectables plant, which is different from a plant where oral solids are made,” says Kim Crabtree, senior director of pharma portfolio management for Henry Schein Medical, a medical supplies distributor. “Those are not as plentiful as a standard pill factory.”

The doses required are also relatively high – 1.2 g of each antibody in Regeneron’s cocktail – which will further strain production capacity. Leah Lipsich, PhD, vice president of strategic program direction at Regeneron, says the company is prepared for high demand and has been able to respond, thanks to its rapid development and manufacturing technology, known as VelociSuite, which allows it to rapidly scale-up from discovery to productions in weeks instead of months.

“We knew supply would be a huge problem for COVID-19, but because we had such confidence in our technology, we went immediately from research-scale to our largest-scale manufacturing,” she says. “We’ve been manufacturing our cocktail for months now.”

The company has also partnered with Roche, the biggest manufacturer and vendor of monoclonal antibodies in the world, to manufacture and supply the drugs. Once full manufacturing capacity is reached in 2021, the companies expect to produce at least 2 million doses a year.

Then there is the issue of getting the drugs from the factories to the places they will be used.

Antibodies are temperature sensitive and need to be refrigerated during transport and storage, so a cold-chain-compliant supply chain is required. Fortunately, they can be kept at standard refrigerator temperatures, ranging from 2° C to 8° C, rather than the ultra-low temperatures required by some COVID-19 vaccines.
 

Two million doses a year

Medical logistics companies have a lot of experience dealing with products like these and are well prepared to handle the new antibody drugs. “There are quite a few products like these on the market, and the supply chain is used to shipping them,” Ms. Crabtree says.

They will be shipped to distribution centers in refrigerated trucks, repacked into smaller lots that can sustain the correct temperature for 24 hours, and then sent to their final destination, often in something as simple as a Styrofoam cooler filled with dry ice.

The expected rise in demand shouldn’t be too much of an issue for distributors either, says Ms. Crabtree; they have built systems that can deal with short-term surges in volume. The annual flu vaccine, for example, involves shipping a lot of product in a very short time, usually from August to November. “The distribution system is used to seasonal variations and peaks in demand,” she says.

The next question is how the treatments will be administered. Although most patients who will receive monoclonal antibodies will be ambulatory and not hospitalized, the administration requires intravenous infusion. Hospitals, of course, have a lot of experience with intravenous drugs, but typically give them only to inpatients. Most other monoclonal antibody drugs – such as those for cancer and autoimmune disorders – are given in specialized suites in doctor’s offices or in stand-alone infusion clinics.

That means that the places best suited to treat COVID-19 patients with antibodies are those that regularly deal with people who are immunocompromised, and such patients should not be interacting with people who have an infectious disease. “How do we protect the staff and other patients?” Dr. Gandhi asks.
 

Protecting staff and other patients

This is not an insurmountable obstacle, he points out, but it is one that requires careful thought and planning to accommodate COVID-19 patients without unduly disrupting life-saving treatments for other patients. It might involve, for example, treating COVID-19 patients in sequestered parts of the clinic or at different times of day, with even greater attention paid to cleaning, he explains. “We now have many months of experience with infection control, so we know how to do this; it’s just a question of logistics.”

But even once all the details around manufacturing, transporting, and administering the drugs are sorted out, there is still the issue of how they will be distributed fairly and equitably.

Despite multiple companies working to produce an array of different antibody drugs, demand is still expected to exceed supply for many months. “With more than 200,000 new cases a day in the United States, there won’t be enough antibodies to treat all of the high-risk patients,” says Dr. Gandhi. “Most of us are worried that demand will far outstrip supply. People are talking about lotteries to determine who gets them.”

The Department of Health and Human Services will continue to distribute the drugs to states on the basis of their COVID-19 burdens, and the states will then decide how much to provide to each health care facility.

Although the HHS goal is to ensure that the drugs reach as many patients as possible, no matter where they live and regardless of their income, there are still concerns that larger facilities serving more affluent areas will end up being favored, if only because they are the ones best equipped to deal with the drugs right now.

“We are all aware that this has affected certain communities more, so we need to make sure that the drugs are used equitably and made available to the communities that were hardest hit,” says Dr. Gandhi. The ability to monitor drug distribution should be built into the rollout, so that institutions and governments will have some sense of whether they are being doled out evenly, he adds.

Equity in distribution will be an issue for the rest of the world as well. Currently, 80% of monoclonal antibodies are sold in Canada, Europe, and the United States; few, if any, are available in low- and middle-income countries. The treatments are expensive: the cost of producing one g of marketed monoclonal antibodies is between $95 and $200, which does not include the cost of R&D, packaging, shipping, or administration. The median price for antibody treatment not related to COVID-19 runs from $15,000 to $200,000 per year in the United States.

Regeneron’s Dr. Lipsich says that the company has not yet set a price for its antibody cocktail. The government paid $450 million for its 300,000 doses, but that price includes the costs of research, manufacturing, and distribution, so is not a useful indicator of the eventual per-dose price. “We’re not in a position to talk about how it will be priced yet, but we will do our best to make it affordable and accessible to all,” she says.

There are some projects underway to ensure that the drugs are made available in poorer countries. In April, the COVID-19 Therapeutics Accelerator – an initiative launched by the Bill & Melinda Gates Foundation, Wellcome, and Mastercard to speed-up the response to the global pandemic – reserved manufacturing capacity with Fujifilm Diosynth Biotechnologies in Denmark for future monoclonal antibody therapies that will supply low- and middle-income countries. In October, the initiative announced that Eli Lilly would use that reserved capacity to produce its antibody drug starting in April 2021.

In the meantime, Lilly will make some of its product manufactured in other facilities available to lower-income countries. To help keep costs down, the company’s collaborators have agreed to waive their royalties on antibodies distributed in low- and middle-income countries.

“Everyone is looking carefully at how the drugs are distributed to ensure all will get access,” said Dr. Lipsich.

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

The United States has allocated more than 641,000 monoclonal antibody treatments for outpatients to ease pressure on strained hospitals, but officials from Operation Warp Speed report that more than half of that reserve sits unused as clinicians grapple with best practices.

There are space and personnel limitations in hospitals right now, Janet Woodcock, MD, therapeutics lead on Operation Warp Speed, acknowledges in an interview with this news organization. “Special areas and procedures must be set up.” And the operation is in the process of broadening availability beyond hospitals, she points out.

But for frontline clinicians, questions about treatment efficacy and the logistics of administering intravenous drugs to infectious outpatients loom large.

More than 50 monoclonal antibody products that target SARS-CoV-2 are now in development. The U.S. Food and Drug Administration has already issued Emergency Use Authorization (EUA) for two such drugs on the basis of phase 2 trial data – bamlanivimab, made by Eli Lilly, and a cocktail of casirivimab plus imdevimab, made by Regeneron – and another two-antibody cocktail from AstraZeneca, AZD7442, has started phase 3 clinical trials. The Regeneron combination was used to treat President Donald Trump when he contracted COVID-19 in October.

Monoclonal antibody drugs are based on the natural antibodies that the body uses to fight infections. They work by binding to a specific target and then blocking its action or flagging it for destruction by other parts of the immune system. Both bamlanivimab and the casirivimab plus imdevimab combination target the spike protein of the virus and stop it from attaching to and entering human cells.
 

Targeting the spike protein out of the hospital

The antibody drugs covered by EUAs do not cure COVID-19, but they have been shown to reduce hospitalizations and visits to the emergency department for patients at high risk for disease progression. They are approved to treat patients older than 12 years with mild to moderate COVID-19 who are at high risk of progressing to severe disease or hospitalization. They are not authorized for use in patients who have been hospitalized or who are on ventilators. The hope is that antibody drugs will reduce the number of severe cases of COVID-19 and ease pressure on overstretched hospitals.

Most COVID-19 patients are outpatients, so we need something to keep them from getting worse.

This is important because it targets the greatest need in COVID-19 therapeutics, says Rajesh Gandhi, MD, an infectious disease physician at Harvard Medical School in Boston, who is a member of two panels evaluating COVID-19 treatments: one for the Infectious Disease Society of America and the other for the National Institutes of Health. “Up to now, most of the focus has been on hospitalized patients,” he says, but “most COVID-19 patients are outpatients, so we need something to keep them from getting worse.”

Both panels have said that, despite the EUAs, more evidence is needed to be sure of the efficacy of the drugs and to determine which patients will benefit the most from them.

These aren’t the mature data from drug development that guideline groups are accustomed to working with, Dr. Woodcock points out. “But this is an emergency and the data taken as a whole are pretty convincing,” she says. “As I look at the totality of the evidence, monoclonal antibodies will have a big effect in keeping people out of the hospital and helping them recover faster.”

High-risk patients are eligible for treatment, especially those older than 65 years and those with comorbidities who are younger. Access to the drugs is increasing for clinicians who are able to infuse safely or work with a site that will.

In the Boston area, several hospitals, including Massachusetts General where Dr. Gandhi works, have set up infusion centers where newly diagnosed patients can get the antibody treatment if their doctor thinks it will benefit them. And Coram, a provider of at-home infusion therapy owned by the CVS pharmacy chain, is running a pilot program offering the Eli Lilly drug to people in seven cities – including Boston, Chicago, Los Angeles, and Tampa – and their surrounding communities with a physician referral.

Getting that referral could be tricky, however, for patients without a primary care physician or for those whose doctor isn’t already connected to one of the institutions providing the infusions. The hospitals are sending out communications on how patients and physicians can get the therapy, but Dr. Gandhi says that making information about access available should be a priority. The window for the effective treatment is small – the drugs appear to work best before patients begin to make their own antibodies, says Dr. Gandhi – so it’s vital that doctors act quickly if they have a patient who is eligible.

And rolling out the new therapies to patients around the world will be a major logistical undertaking.

The first hurdle will be making enough of them to go around. Case numbers are skyrocketing around the globe, and producing the drugs is a complex time- and labor-intensive process that requires specialized facilities. Antibodies are produced by cell lines in bioreactors, so a plant that churns out generic aspirin tablets can’t simply be converted into an antibody factory.

“These types of drugs are manufactured in a sterile injectables plant, which is different from a plant where oral solids are made,” says Kim Crabtree, senior director of pharma portfolio management for Henry Schein Medical, a medical supplies distributor. “Those are not as plentiful as a standard pill factory.”

The doses required are also relatively high – 1.2 g of each antibody in Regeneron’s cocktail – which will further strain production capacity. Leah Lipsich, PhD, vice president of strategic program direction at Regeneron, says the company is prepared for high demand and has been able to respond, thanks to its rapid development and manufacturing technology, known as VelociSuite, which allows it to rapidly scale-up from discovery to productions in weeks instead of months.

“We knew supply would be a huge problem for COVID-19, but because we had such confidence in our technology, we went immediately from research-scale to our largest-scale manufacturing,” she says. “We’ve been manufacturing our cocktail for months now.”

The company has also partnered with Roche, the biggest manufacturer and vendor of monoclonal antibodies in the world, to manufacture and supply the drugs. Once full manufacturing capacity is reached in 2021, the companies expect to produce at least 2 million doses a year.

Then there is the issue of getting the drugs from the factories to the places they will be used.

Antibodies are temperature sensitive and need to be refrigerated during transport and storage, so a cold-chain-compliant supply chain is required. Fortunately, they can be kept at standard refrigerator temperatures, ranging from 2° C to 8° C, rather than the ultra-low temperatures required by some COVID-19 vaccines.
 

Two million doses a year

Medical logistics companies have a lot of experience dealing with products like these and are well prepared to handle the new antibody drugs. “There are quite a few products like these on the market, and the supply chain is used to shipping them,” Ms. Crabtree says.

They will be shipped to distribution centers in refrigerated trucks, repacked into smaller lots that can sustain the correct temperature for 24 hours, and then sent to their final destination, often in something as simple as a Styrofoam cooler filled with dry ice.

The expected rise in demand shouldn’t be too much of an issue for distributors either, says Ms. Crabtree; they have built systems that can deal with short-term surges in volume. The annual flu vaccine, for example, involves shipping a lot of product in a very short time, usually from August to November. “The distribution system is used to seasonal variations and peaks in demand,” she says.

The next question is how the treatments will be administered. Although most patients who will receive monoclonal antibodies will be ambulatory and not hospitalized, the administration requires intravenous infusion. Hospitals, of course, have a lot of experience with intravenous drugs, but typically give them only to inpatients. Most other monoclonal antibody drugs – such as those for cancer and autoimmune disorders – are given in specialized suites in doctor’s offices or in stand-alone infusion clinics.

That means that the places best suited to treat COVID-19 patients with antibodies are those that regularly deal with people who are immunocompromised, and such patients should not be interacting with people who have an infectious disease. “How do we protect the staff and other patients?” Dr. Gandhi asks.
 

Protecting staff and other patients

This is not an insurmountable obstacle, he points out, but it is one that requires careful thought and planning to accommodate COVID-19 patients without unduly disrupting life-saving treatments for other patients. It might involve, for example, treating COVID-19 patients in sequestered parts of the clinic or at different times of day, with even greater attention paid to cleaning, he explains. “We now have many months of experience with infection control, so we know how to do this; it’s just a question of logistics.”

But even once all the details around manufacturing, transporting, and administering the drugs are sorted out, there is still the issue of how they will be distributed fairly and equitably.

Despite multiple companies working to produce an array of different antibody drugs, demand is still expected to exceed supply for many months. “With more than 200,000 new cases a day in the United States, there won’t be enough antibodies to treat all of the high-risk patients,” says Dr. Gandhi. “Most of us are worried that demand will far outstrip supply. People are talking about lotteries to determine who gets them.”

The Department of Health and Human Services will continue to distribute the drugs to states on the basis of their COVID-19 burdens, and the states will then decide how much to provide to each health care facility.

Although the HHS goal is to ensure that the drugs reach as many patients as possible, no matter where they live and regardless of their income, there are still concerns that larger facilities serving more affluent areas will end up being favored, if only because they are the ones best equipped to deal with the drugs right now.

“We are all aware that this has affected certain communities more, so we need to make sure that the drugs are used equitably and made available to the communities that were hardest hit,” says Dr. Gandhi. The ability to monitor drug distribution should be built into the rollout, so that institutions and governments will have some sense of whether they are being doled out evenly, he adds.

Equity in distribution will be an issue for the rest of the world as well. Currently, 80% of monoclonal antibodies are sold in Canada, Europe, and the United States; few, if any, are available in low- and middle-income countries. The treatments are expensive: the cost of producing one g of marketed monoclonal antibodies is between $95 and $200, which does not include the cost of R&D, packaging, shipping, or administration. The median price for antibody treatment not related to COVID-19 runs from $15,000 to $200,000 per year in the United States.

Regeneron’s Dr. Lipsich says that the company has not yet set a price for its antibody cocktail. The government paid $450 million for its 300,000 doses, but that price includes the costs of research, manufacturing, and distribution, so is not a useful indicator of the eventual per-dose price. “We’re not in a position to talk about how it will be priced yet, but we will do our best to make it affordable and accessible to all,” she says.

There are some projects underway to ensure that the drugs are made available in poorer countries. In April, the COVID-19 Therapeutics Accelerator – an initiative launched by the Bill & Melinda Gates Foundation, Wellcome, and Mastercard to speed-up the response to the global pandemic – reserved manufacturing capacity with Fujifilm Diosynth Biotechnologies in Denmark for future monoclonal antibody therapies that will supply low- and middle-income countries. In October, the initiative announced that Eli Lilly would use that reserved capacity to produce its antibody drug starting in April 2021.

In the meantime, Lilly will make some of its product manufactured in other facilities available to lower-income countries. To help keep costs down, the company’s collaborators have agreed to waive their royalties on antibodies distributed in low- and middle-income countries.

“Everyone is looking carefully at how the drugs are distributed to ensure all will get access,” said Dr. Lipsich.

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

The United States added over 171,000 new COVID-19 cases in children during the week ending Jan. 7, but that figure is lower than 3 of the previous 4 weeks, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

Despite an increase compared with the week ending Dec. 31, the most recent weekly total is down from the high of 182,000 cases reported for the week ending Dec. 17, based on data collected from the health department websites of 49 states (excluding New York), the District of Columbia, New York City, Puerto Rico, and Guam.

Those jurisdictions have recorded a total of almost 2.3 million COVID-19 cases in children since the beginning of the pandemic, which amounts to 12.5% of reported cases among all ages. The 171,000 child cases for the most recent week represented 12.9% of the more than 1.3 million cases nationwide, the AAP and CHA said in their latest weekly update.

The United States now has a rate of 3,055 COVID-19 cases per 100,000 children in the population, the report shows, with 31 states above that figure and 14 states reporting rates above 4,500 per 100,000 children.

Severe illness, however, continues to be rare among children. So far, children represent 1.8% of all hospitalizations in the jurisdictions reporting such data (24 states and New York City), and just 0.9% of infected children have been hospitalized. There have been 188 deaths among children in 42 states and New York City, which makes up just 0.06% of the total for all ages in those jurisdictions, the AAP and CHA reported.

There are 13 states that have reported no coronavirus-related deaths in children, while Texas (34), New York City (21), Arizona (17), and Illinois (11) are the only jurisdictions with 10 or more. Nevada has the highest proportion of child deaths to all deaths at 0.2%, with Arizona and Nebraska next at 0.18%, according to the AAP/CHA report.

[email protected]

The United States added over 171,000 new COVID-19 cases in children during the week ending Jan. 7, but that figure is lower than 3 of the previous 4 weeks, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

Despite an increase compared with the week ending Dec. 31, the most recent weekly total is down from the high of 182,000 cases reported for the week ending Dec. 17, based on data collected from the health department websites of 49 states (excluding New York), the District of Columbia, New York City, Puerto Rico, and Guam.

Those jurisdictions have recorded a total of almost 2.3 million COVID-19 cases in children since the beginning of the pandemic, which amounts to 12.5% of reported cases among all ages. The 171,000 child cases for the most recent week represented 12.9% of the more than 1.3 million cases nationwide, the AAP and CHA said in their latest weekly update.

The United States now has a rate of 3,055 COVID-19 cases per 100,000 children in the population, the report shows, with 31 states above that figure and 14 states reporting rates above 4,500 per 100,000 children.

Severe illness, however, continues to be rare among children. So far, children represent 1.8% of all hospitalizations in the jurisdictions reporting such data (24 states and New York City), and just 0.9% of infected children have been hospitalized. There have been 188 deaths among children in 42 states and New York City, which makes up just 0.06% of the total for all ages in those jurisdictions, the AAP and CHA reported.

There are 13 states that have reported no coronavirus-related deaths in children, while Texas (34), New York City (21), Arizona (17), and Illinois (11) are the only jurisdictions with 10 or more. Nevada has the highest proportion of child deaths to all deaths at 0.2%, with Arizona and Nebraska next at 0.18%, according to the AAP/CHA report.

[email protected]

The United States added over 171,000 new COVID-19 cases in children during the week ending Jan. 7, but that figure is lower than 3 of the previous 4 weeks, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

Despite an increase compared with the week ending Dec. 31, the most recent weekly total is down from the high of 182,000 cases reported for the week ending Dec. 17, based on data collected from the health department websites of 49 states (excluding New York), the District of Columbia, New York City, Puerto Rico, and Guam.

Those jurisdictions have recorded a total of almost 2.3 million COVID-19 cases in children since the beginning of the pandemic, which amounts to 12.5% of reported cases among all ages. The 171,000 child cases for the most recent week represented 12.9% of the more than 1.3 million cases nationwide, the AAP and CHA said in their latest weekly update.

The United States now has a rate of 3,055 COVID-19 cases per 100,000 children in the population, the report shows, with 31 states above that figure and 14 states reporting rates above 4,500 per 100,000 children.

Severe illness, however, continues to be rare among children. So far, children represent 1.8% of all hospitalizations in the jurisdictions reporting such data (24 states and New York City), and just 0.9% of infected children have been hospitalized. There have been 188 deaths among children in 42 states and New York City, which makes up just 0.06% of the total for all ages in those jurisdictions, the AAP and CHA reported.

There are 13 states that have reported no coronavirus-related deaths in children, while Texas (34), New York City (21), Arizona (17), and Illinois (11) are the only jurisdictions with 10 or more. Nevada has the highest proportion of child deaths to all deaths at 0.2%, with Arizona and Nebraska next at 0.18%, according to the AAP/CHA report.

[email protected]

There’s little doubt that the COVID-19 pandemic has been hard on many children and adolescents just as it has been difficult for adults. The disruption of routines, reduced contact with friends, concern over getting ill, and financial turmoil suffered by many families is exacting a toll on our mental health, as has been documented by a number of recent surveys and studies.^1,2

Quite understandably, concern about rising levels of anxiety and depression in youth prompts additional worries about suicide, the second leading cause of death in adolescents and young adults. In response, many organizations have rallied to provide additional resources to help prevent suicidal thinking and actions. Online mental health tips, support phone and text lines, and the availability of telemedicine have all been mobilized to help people cope and stay safe both physically and psychologically.

But what are the actual numbers when it comes to youth suicide during COVID-19? According to many headlines in the press, the statistics are grim and support many of distressing predictions that have been made. A December story in an Arizona newspaper, “With Teen Suicides on the Rise, Tucson Educators Struggle to Prioritize Mental Health,” described a 67% increase in teen suicides in 2020 compared with 2019 in one county.³ Another post from Psychology Today, “America is Facing a Teen Suicide Pandemic,” raised similar alarms.⁴ Concern over suicide has even been used politically to argue against restrictions that could reduce the spread of COVID-19 infections.

But despite this common perception shared by both health care professionals and the public, there actually is not evidence at this point that the COVID-19 pandemic has led to a broad spike in youth suicide deaths or attempts. A recent study published in the journal Pediatrics compared suicide screening results on youth presenting to emergency departments for any reason in 2020 to the same month in 2019.⁵ The authors found no consistent increases in reported suicidal ideation or suicide attempts with scattered elevations found in some months during 2020 compared with the previous year (including February 2020 before the pandemic really began) but not others. Internationally, newly analyzed data from 2020 with regard to suicide deaths have suggested “either no rise in suicide rates ... or a fall in the early months of the pandemic.” In my home and, admittedly small, state of Vermont, data from the Department of Health have shown 93 suicide deaths across all ages as of mid-November 2020 compared with a 5-year average of 96.

Why don’t the data match the headlines? There are a number of possibilities.

1. Suicide rates in youth were going up before the pandemic. As it takes time to verify and analyze data from large populations, many of the reports on suicide that have been published and released in 2020 summarize data from prior years. Without looking closely, a news organization can easily slap on a headline that implies that the data were obtained during the pandemic.

2. Fluctuations tend to occur from year to year. Thankfully, youth suicide remains rare (although not rare enough). With small numbers, regular variations from year to year can look huge in terms of percentages, especially if one doesn’t pull back and look at longer trends over time.

3. People are reaching out for mental health services. The public health message to access support and treatment for COVID 19–related mental health struggles appears to be having an effect, but this increased demand should not necessarily be viewed as a proxy for suicidal ideation and attempts.

While the understanding that we are not actually in the midst of a surge in COVID 19–related youth suicide is reassuring, it is important not to get complacent. Much of the data remains preliminary, and, even if these numbers hold up, there is no guarantee that things will continue this way, especially if the pandemic and it restrictions continue to drag on for many more months. And of course, whether or not the pandemic is making things significantly worse, youth suicide remains an enormous public health imperative with every one being a human tragedy.

It is also quite possible that more detailed analyses will eventually reveal a more complex association between youth suicide and COVID-19, with effects of the pandemic being realized regionally or more for some groups than others. Data from before the pandemic indicated, for example, that suicide rates are increasing more rapidly among African American youth compared with white children and adolescents.⁶ With the COVID-19 pandemic itself affecting disadvantaged communities more strongly, one could readily expect variable impacts in mental health related to race or socioeconomic status. A recent article voices these concerns for indigenous youth in Montana: a state with one of the highest per capita suicide rates in the country.⁷ The article notes, however, that the rate of suicide overall in Montana in 2020 is comparable to those of previous years.

Overall, pediatricians should not be needlessly panicked that the COVID-19 pandemic has sparked a surge in youth suicide. The data at this point simply don’t support that assertion despite many headlines to the contrary. At the same time, many children and adolescents are certainly struggling with the stresses the pandemic has created and continue to need our close monitoring and support.
 

Dr. Rettew is a child and adolescent psychiatrist and associate professor of psychiatry and pediatrics at the University of Vermont Larner College of Medicine. Follow him on Twitter @PediPsych. His new book, “Parenting Made Complicated: What Science Really Knows About the Greatest Debates of Early Childhood,” launches Feb. 1, 2021.

References

1. Copeland WE et al. Impact of COVID-19 pandemic on college student mental health and wellness. J Am Acad Child Adolesc Psychiatry. 2020;60(1):134-41. doi: 10.1016/j.jaac.2020.08.466.

2. Qiu J et al. A nationwide survey of psychological distress among Chinese people in the COVID-19 epidemic: Implications and policy recommendations. Gen Psychiatry. 2020;33:e100213. doi: 10.1136/gpsych-2020-100213.

3. Dhmara K. With teen suicides on the rise, Tucson educators struggle to prioritize mental health. Tuscon.com. Dec. 27, 2020.

4. Chafouleas, SM. America is facing a suicide epidemic: New data confirm the urgency of confronting it now. Psychology Today blog. Sept. 4, 2020.

5. Hill RM et al. Suicide ideation and attempts in a pediatric emergency department before and after COVID-19. Pediatrics. 2020. doi: 10.1542/peds.2020-029280.

6. John A et al. Trends in suicide during the covid-19 pandemic. BMJ 2020;371:m4352. doi: 10.1136/bmj.m4352.

7. Reardon S. Health officials fear COVID-19 pandemic-related suicide spike among indigenous youth. Time Magazine. December 2020.

There’s little doubt that the COVID-19 pandemic has been hard on many children and adolescents just as it has been difficult for adults. The disruption of routines, reduced contact with friends, concern over getting ill, and financial turmoil suffered by many families is exacting a toll on our mental health, as has been documented by a number of recent surveys and studies.^1,2

Quite understandably, concern about rising levels of anxiety and depression in youth prompts additional worries about suicide, the second leading cause of death in adolescents and young adults. In response, many organizations have rallied to provide additional resources to help prevent suicidal thinking and actions. Online mental health tips, support phone and text lines, and the availability of telemedicine have all been mobilized to help people cope and stay safe both physically and psychologically.

But what are the actual numbers when it comes to youth suicide during COVID-19? According to many headlines in the press, the statistics are grim and support many of distressing predictions that have been made. A December story in an Arizona newspaper, “With Teen Suicides on the Rise, Tucson Educators Struggle to Prioritize Mental Health,” described a 67% increase in teen suicides in 2020 compared with 2019 in one county.³ Another post from Psychology Today, “America is Facing a Teen Suicide Pandemic,” raised similar alarms.⁴ Concern over suicide has even been used politically to argue against restrictions that could reduce the spread of COVID-19 infections.

But despite this common perception shared by both health care professionals and the public, there actually is not evidence at this point that the COVID-19 pandemic has led to a broad spike in youth suicide deaths or attempts. A recent study published in the journal Pediatrics compared suicide screening results on youth presenting to emergency departments for any reason in 2020 to the same month in 2019.⁵ The authors found no consistent increases in reported suicidal ideation or suicide attempts with scattered elevations found in some months during 2020 compared with the previous year (including February 2020 before the pandemic really began) but not others. Internationally, newly analyzed data from 2020 with regard to suicide deaths have suggested “either no rise in suicide rates ... or a fall in the early months of the pandemic.” In my home and, admittedly small, state of Vermont, data from the Department of Health have shown 93 suicide deaths across all ages as of mid-November 2020 compared with a 5-year average of 96.

Why don’t the data match the headlines? There are a number of possibilities.

1. Suicide rates in youth were going up before the pandemic. As it takes time to verify and analyze data from large populations, many of the reports on suicide that have been published and released in 2020 summarize data from prior years. Without looking closely, a news organization can easily slap on a headline that implies that the data were obtained during the pandemic.

2. Fluctuations tend to occur from year to year. Thankfully, youth suicide remains rare (although not rare enough). With small numbers, regular variations from year to year can look huge in terms of percentages, especially if one doesn’t pull back and look at longer trends over time.

3. People are reaching out for mental health services. The public health message to access support and treatment for COVID 19–related mental health struggles appears to be having an effect, but this increased demand should not necessarily be viewed as a proxy for suicidal ideation and attempts.

While the understanding that we are not actually in the midst of a surge in COVID 19–related youth suicide is reassuring, it is important not to get complacent. Much of the data remains preliminary, and, even if these numbers hold up, there is no guarantee that things will continue this way, especially if the pandemic and it restrictions continue to drag on for many more months. And of course, whether or not the pandemic is making things significantly worse, youth suicide remains an enormous public health imperative with every one being a human tragedy.

It is also quite possible that more detailed analyses will eventually reveal a more complex association between youth suicide and COVID-19, with effects of the pandemic being realized regionally or more for some groups than others. Data from before the pandemic indicated, for example, that suicide rates are increasing more rapidly among African American youth compared with white children and adolescents.⁶ With the COVID-19 pandemic itself affecting disadvantaged communities more strongly, one could readily expect variable impacts in mental health related to race or socioeconomic status. A recent article voices these concerns for indigenous youth in Montana: a state with one of the highest per capita suicide rates in the country.⁷ The article notes, however, that the rate of suicide overall in Montana in 2020 is comparable to those of previous years.

Overall, pediatricians should not be needlessly panicked that the COVID-19 pandemic has sparked a surge in youth suicide. The data at this point simply don’t support that assertion despite many headlines to the contrary. At the same time, many children and adolescents are certainly struggling with the stresses the pandemic has created and continue to need our close monitoring and support.
 

Dr. Rettew is a child and adolescent psychiatrist and associate professor of psychiatry and pediatrics at the University of Vermont Larner College of Medicine. Follow him on Twitter @PediPsych. His new book, “Parenting Made Complicated: What Science Really Knows About the Greatest Debates of Early Childhood,” launches Feb. 1, 2021.

References

1. Copeland WE et al. Impact of COVID-19 pandemic on college student mental health and wellness. J Am Acad Child Adolesc Psychiatry. 2020;60(1):134-41. doi: 10.1016/j.jaac.2020.08.466.

2. Qiu J et al. A nationwide survey of psychological distress among Chinese people in the COVID-19 epidemic: Implications and policy recommendations. Gen Psychiatry. 2020;33:e100213. doi: 10.1136/gpsych-2020-100213.

3. Dhmara K. With teen suicides on the rise, Tucson educators struggle to prioritize mental health. Tuscon.com. Dec. 27, 2020.

4. Chafouleas, SM. America is facing a suicide epidemic: New data confirm the urgency of confronting it now. Psychology Today blog. Sept. 4, 2020.

5. Hill RM et al. Suicide ideation and attempts in a pediatric emergency department before and after COVID-19. Pediatrics. 2020. doi: 10.1542/peds.2020-029280.

6. John A et al. Trends in suicide during the covid-19 pandemic. BMJ 2020;371:m4352. doi: 10.1136/bmj.m4352.

7. Reardon S. Health officials fear COVID-19 pandemic-related suicide spike among indigenous youth. Time Magazine. December 2020.

There’s little doubt that the COVID-19 pandemic has been hard on many children and adolescents just as it has been difficult for adults. The disruption of routines, reduced contact with friends, concern over getting ill, and financial turmoil suffered by many families is exacting a toll on our mental health, as has been documented by a number of recent surveys and studies.^1,2

Quite understandably, concern about rising levels of anxiety and depression in youth prompts additional worries about suicide, the second leading cause of death in adolescents and young adults. In response, many organizations have rallied to provide additional resources to help prevent suicidal thinking and actions. Online mental health tips, support phone and text lines, and the availability of telemedicine have all been mobilized to help people cope and stay safe both physically and psychologically.

But what are the actual numbers when it comes to youth suicide during COVID-19? According to many headlines in the press, the statistics are grim and support many of distressing predictions that have been made. A December story in an Arizona newspaper, “With Teen Suicides on the Rise, Tucson Educators Struggle to Prioritize Mental Health,” described a 67% increase in teen suicides in 2020 compared with 2019 in one county.³ Another post from Psychology Today, “America is Facing a Teen Suicide Pandemic,” raised similar alarms.⁴ Concern over suicide has even been used politically to argue against restrictions that could reduce the spread of COVID-19 infections.

But despite this common perception shared by both health care professionals and the public, there actually is not evidence at this point that the COVID-19 pandemic has led to a broad spike in youth suicide deaths or attempts. A recent study published in the journal Pediatrics compared suicide screening results on youth presenting to emergency departments for any reason in 2020 to the same month in 2019.⁵ The authors found no consistent increases in reported suicidal ideation or suicide attempts with scattered elevations found in some months during 2020 compared with the previous year (including February 2020 before the pandemic really began) but not others. Internationally, newly analyzed data from 2020 with regard to suicide deaths have suggested “either no rise in suicide rates ... or a fall in the early months of the pandemic.” In my home and, admittedly small, state of Vermont, data from the Department of Health have shown 93 suicide deaths across all ages as of mid-November 2020 compared with a 5-year average of 96.

Why don’t the data match the headlines? There are a number of possibilities.

1. Suicide rates in youth were going up before the pandemic. As it takes time to verify and analyze data from large populations, many of the reports on suicide that have been published and released in 2020 summarize data from prior years. Without looking closely, a news organization can easily slap on a headline that implies that the data were obtained during the pandemic.

2. Fluctuations tend to occur from year to year. Thankfully, youth suicide remains rare (although not rare enough). With small numbers, regular variations from year to year can look huge in terms of percentages, especially if one doesn’t pull back and look at longer trends over time.

3. People are reaching out for mental health services. The public health message to access support and treatment for COVID 19–related mental health struggles appears to be having an effect, but this increased demand should not necessarily be viewed as a proxy for suicidal ideation and attempts.

While the understanding that we are not actually in the midst of a surge in COVID 19–related youth suicide is reassuring, it is important not to get complacent. Much of the data remains preliminary, and, even if these numbers hold up, there is no guarantee that things will continue this way, especially if the pandemic and it restrictions continue to drag on for many more months. And of course, whether or not the pandemic is making things significantly worse, youth suicide remains an enormous public health imperative with every one being a human tragedy.

It is also quite possible that more detailed analyses will eventually reveal a more complex association between youth suicide and COVID-19, with effects of the pandemic being realized regionally or more for some groups than others. Data from before the pandemic indicated, for example, that suicide rates are increasing more rapidly among African American youth compared with white children and adolescents.⁶ With the COVID-19 pandemic itself affecting disadvantaged communities more strongly, one could readily expect variable impacts in mental health related to race or socioeconomic status. A recent article voices these concerns for indigenous youth in Montana: a state with one of the highest per capita suicide rates in the country.⁷ The article notes, however, that the rate of suicide overall in Montana in 2020 is comparable to those of previous years.

Overall, pediatricians should not be needlessly panicked that the COVID-19 pandemic has sparked a surge in youth suicide. The data at this point simply don’t support that assertion despite many headlines to the contrary. At the same time, many children and adolescents are certainly struggling with the stresses the pandemic has created and continue to need our close monitoring and support.
 

Dr. Rettew is a child and adolescent psychiatrist and associate professor of psychiatry and pediatrics at the University of Vermont Larner College of Medicine. Follow him on Twitter @PediPsych. His new book, “Parenting Made Complicated: What Science Really Knows About the Greatest Debates of Early Childhood,” launches Feb. 1, 2021.

References

1. Copeland WE et al. Impact of COVID-19 pandemic on college student mental health and wellness. J Am Acad Child Adolesc Psychiatry. 2020;60(1):134-41. doi: 10.1016/j.jaac.2020.08.466.

2. Qiu J et al. A nationwide survey of psychological distress among Chinese people in the COVID-19 epidemic: Implications and policy recommendations. Gen Psychiatry. 2020;33:e100213. doi: 10.1136/gpsych-2020-100213.

3. Dhmara K. With teen suicides on the rise, Tucson educators struggle to prioritize mental health. Tuscon.com. Dec. 27, 2020.

4. Chafouleas, SM. America is facing a suicide epidemic: New data confirm the urgency of confronting it now. Psychology Today blog. Sept. 4, 2020.

5. Hill RM et al. Suicide ideation and attempts in a pediatric emergency department before and after COVID-19. Pediatrics. 2020. doi: 10.1542/peds.2020-029280.

6. John A et al. Trends in suicide during the covid-19 pandemic. BMJ 2020;371:m4352. doi: 10.1136/bmj.m4352.

7. Reardon S. Health officials fear COVID-19 pandemic-related suicide spike among indigenous youth. Time Magazine. December 2020.