Clinical Endocrinology News

Diabetes care and access to insulin and other medications in Ukraine have been “severely disrupted” since Russia’s invasion, with shortages resulting more from distribution problems than supply itself, according to multiple sources.

In 2021, there were about 2.3 million people with diabetes in Ukraine, roughly 7% of the total population. Of those, about 120,000 have type 1 diabetes and depend on insulin to live, while a similar number have insulin-treated type 2 diabetes.

Donations of insulin, other medications, and supplies have been pouring in since late February from sources including the Ukrainian diaspora, nongovernmental organizations, other European governments, universities, and product manufacturers. “The main problem now is logistic,” Boris Mankovsky, MD, president of the Ukrainian Diabetology Association, said in an interview.

Insulin manufacturer Novo Nordisk’s warehouse continues to operate, although deliveries have been curtailed because of shortages in delivery staff. The company is working to get medications to patients either through pharmacies or humanitarian organizations and has funded refugee support efforts, they said in a March 8 statement.

But even if the supplies reach the pharmacies, they may not reach patients for a variety of logistical reasons, noted Dr. Mankovsky, who is head of the department of diabetology at the P.L. Shupyk National Medical Academy for Postgraduate Education in Kyiv. “So, there are a lot of problems. I don’t know exactly where the main bottleneck is, but there are shortages, definitely.”

Insulin supplies have also been distributed very unequally by region and type, with various shipments containing long-acting, short-acting, analog, or human insulins. “We’re very grateful for all of it. But it’s not centrally coordinated, which of course is understandable, but it means that a lot of donations go to one place and no supply goes to another,” Dr. Mankovsky said.

Most of the donated supplies have been going to western Ukraine, where the capital Kyiv is located. “But the main problem now is the eastern part of Ukraine. It’s difficult and dangerous to deliver any supplies there, especially [with] the terrible situation in Mariupol. Eastern Ukraine now suffers the most, at least at this minute,” he said.  
 

Diabetes specialists continue to work, at least for now  

Ivan Smirnov, MD, PhD, head of the endocrinology department at Kharkiv Regional Hospital, in the northeastern part of the country, said in an email to this news organization: “I continue to stay in Kharkiv, in spite of the situation. A lot of people are killed, many people are wounded. My hospital is full of wounded civilians ... a lot of buildings are destroyed partly and some completely.”

Dr. Smirnov said that he and his colleagues “find the way to overcome the fear ... in constant work. Part of the work is online consulting assistance for routine patients. ... But the main time now is dedicated to providing the diabetes patients with insulin. This is a heavy job to do indeed.”

Dr. Mankovsky, who practices adult diabetology and endocrinology in Kyiv, continues to manage patients, but mostly remotely. “Practice is severely disrupted. I’m willing to see patients but it’s extremely difficult and dangerous for them and probably not possible to travel to see me. So that’s why all our communications now is distant, through phone or internet. ... We can communicate and I’m able to provide some recommendations for changes in treatment or some corrections in insulin therapy.”

Despite the Russians closing in on Kyiv, Dr. Mankovsky said, “I’ve decided to stay as long as possible. Then, nobody knows of course but I think I have to. ... We hear explosions every day. ... I’m in the center of the city and the streets are empty. It’s heartbreaking.”
 

Supplies are reaching refugees

Dr. Mankovsky said: “Now we have huge movement of refugees. Among them are a lot of people with diabetes who moved out of their place and nobody knows where they are. It’s really a huge disruption.”

According to the type 1 diabetes advocacy organization JDRF, many men with diabetes aged 18-60 are remaining in Ukraine to fight, despite the increased risk with the disease. But an estimated 15,000 children with type 1 diabetes and their families are attempting to escape the conflict by moving to the western regions of the country or over the borders.

“Those who make it to Hungary, Moldova, Poland, or Romania are being received with wonderful generosity. We have heard stories ranging from governments making it possible to pick up insulin free without a script to individuals emptying their cupboards of insulin for those whose need is urgent,” JDRF said in a statement on March 2.  

For its part, Novo Nordisk has donated 55 million Danish kroner (about 7.3 million Euros, or $8.2 million U.S. dollars) to support international relief organizations in assisting refugees.

Ivan Tkac, MD, PhD, professor of medicine at Safárik University in Kosice, Slovakia, is assisting refugees, including those with diabetes. Slovakia is predominantly a transit country for refugees from Ukraine, he said in an interview. 

“However, in solidarity with Ukraine, we are providing emergency medical care for both Ukrainians and refugees from third countries leaving Ukraine,” he said, noting that those individuals are primarily foreign students who had been studying there.

“Asylum seekers receive full medical insurance paid by the government of the Slovak Republic. As part of this care, the refugees are provided with the necessary amount of insulin and other antidiabetic drugs, as well as medical devices needed for the treatment of diabetes. The European Commission has pledged to supply Slovakia with the necessary quantities of medicines for the treatment of diabetes in the coming weeks as part of its assistance to the countries bordering Ukraine. In addition, some humanitarian organizations are organizing supplies of insulin and other medicines for soldiers fighting in the Ukrainian army,” Dr. Tkac said.
 

How you can help

A number of organizations are providing assistance specifically to people with diabetes, as well as broader medical assistance to people remaining in Ukraine and to refugees.

A collaboration between the Ministry of Health of Ukraine, the humanitarian agency Direct Relief, and the International Diabetes Federation is working to determine where supplies are short, to secure donations within Europe, and to open up “green corridors” within Ukraine to deliver them quickly to where they’re needed. They have asked those who wish to help to donate to Direct Relief and direct donations to the “Ukraine crisis.”

Another effort organized by IDF Europe is Connect Solidarity, a program that “aims to facilitate support from IDF Europe member associations across Europe wishing to help other national diabetes associations in Ukraine’s neighboring countries, provide advice, medicines, and supplies to Ukrainian refugees.”

IDF President Andrew Boulton, MD, told this news organization that he has been in almost daily contact with senior colleagues working in diabetes in Ukraine, and that he is working with the organization’s affiliated charity Life for a Child in addition to the other charitable agencies. “We will continue to do our utmost best to help those with diabetes living in Ukraine. However, this is, of course, very challenging, and we hope that we are doing the best we can in such a difficult situation. We all hope and pray that this situation is soon resolved.”

The European Association for the Study of Diabetes is taking a somewhat different approach, by encouraging its members to “support people with ill health, including diabetes, with donations through established [nongovernmental organizations] that have the capacity to help on site, such as United Nations High Commissioner for Refugees or International Committee of the Red Cross.”

Dr. Mankovsky told this news organization that he is very grateful for all the support from around the world: “Just thanks. I’ve got so much support, so many phone calls, so many letters ... not just me, all of us. People wise and friendship wise we feel support. It’s really important, emotionally and with insulin supply and other medications. Without that, it would be much more difficult.”
 

Pandemic-prompted changes enable wartime diabetes care

Dramatic changes in diabetes care delivery in Ukraine necessitated by the COVID-19 pandemic have proved indispensable during the Russian invasion.

In a piece published May 29, 2020, in the Journal of Diabetes Science and Technology, Dr. Mankovsky described how the pandemic hit just as Ukraine’s health system was pivoting from government controlled to insurance based.

Prior to the pandemic, patients with both type 1 and type 2 diabetes were regularly admitted to hospital for routine checkups, insulin dose management, and other treatments, a “remnant of the Soviet-era medical practice, which emphasized heavily on hospital admissions,” Dr. Mankovsky said in an interview.

This was the case, he wrote in the article, “despite the common understanding that such a system was a waste of resources ... this policy was changing much slower than we wanted.”

But the COVID-19 pandemic changed that practice “abruptly and dramatically,” so that all hospitalizations for patients with diabetes were stopped unless there was a real metabolic emergency.

Subsequently, Dr. Mankovsky wrote, “almost every health professional recognizes the particular importance of the new ways of communications with patients and with other colleagues.”

Indeed, in his email to this news organization, Dr. Smirnov mentioned that the routine diabetes management work he is still able to do remotely despite the extreme disruption in his region “is easy because of long-term COVID-period experience.”

Also because of the pandemic, insulin prescriptions were switched from traditional paper to electronic transfer, so that patients could easily pick them up at the pharmacy. “This new ... system proved to be not just very convenient for all parties involved, but in the current situation, it allowed us to prevent so many medically unnecessary visits to the clinics, which otherwise would have presented the real threat to the patients’ health and risk to get them infected,” Dr. Mankovsky wrote in 2020.

Now with the new danger, he said, “the inability to see patients is probably the least of our problems.”

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

Diabetes care and access to insulin and other medications in Ukraine have been “severely disrupted” since Russia’s invasion, with shortages resulting more from distribution problems than supply itself, according to multiple sources.

In 2021, there were about 2.3 million people with diabetes in Ukraine, roughly 7% of the total population. Of those, about 120,000 have type 1 diabetes and depend on insulin to live, while a similar number have insulin-treated type 2 diabetes.

Donations of insulin, other medications, and supplies have been pouring in since late February from sources including the Ukrainian diaspora, nongovernmental organizations, other European governments, universities, and product manufacturers. “The main problem now is logistic,” Boris Mankovsky, MD, president of the Ukrainian Diabetology Association, said in an interview.

Insulin manufacturer Novo Nordisk’s warehouse continues to operate, although deliveries have been curtailed because of shortages in delivery staff. The company is working to get medications to patients either through pharmacies or humanitarian organizations and has funded refugee support efforts, they said in a March 8 statement.

But even if the supplies reach the pharmacies, they may not reach patients for a variety of logistical reasons, noted Dr. Mankovsky, who is head of the department of diabetology at the P.L. Shupyk National Medical Academy for Postgraduate Education in Kyiv. “So, there are a lot of problems. I don’t know exactly where the main bottleneck is, but there are shortages, definitely.”

Insulin supplies have also been distributed very unequally by region and type, with various shipments containing long-acting, short-acting, analog, or human insulins. “We’re very grateful for all of it. But it’s not centrally coordinated, which of course is understandable, but it means that a lot of donations go to one place and no supply goes to another,” Dr. Mankovsky said.

Most of the donated supplies have been going to western Ukraine, where the capital Kyiv is located. “But the main problem now is the eastern part of Ukraine. It’s difficult and dangerous to deliver any supplies there, especially [with] the terrible situation in Mariupol. Eastern Ukraine now suffers the most, at least at this minute,” he said.  
 

Diabetes specialists continue to work, at least for now  

Ivan Smirnov, MD, PhD, head of the endocrinology department at Kharkiv Regional Hospital, in the northeastern part of the country, said in an email to this news organization: “I continue to stay in Kharkiv, in spite of the situation. A lot of people are killed, many people are wounded. My hospital is full of wounded civilians ... a lot of buildings are destroyed partly and some completely.”

Dr. Smirnov said that he and his colleagues “find the way to overcome the fear ... in constant work. Part of the work is online consulting assistance for routine patients. ... But the main time now is dedicated to providing the diabetes patients with insulin. This is a heavy job to do indeed.”

Dr. Mankovsky, who practices adult diabetology and endocrinology in Kyiv, continues to manage patients, but mostly remotely. “Practice is severely disrupted. I’m willing to see patients but it’s extremely difficult and dangerous for them and probably not possible to travel to see me. So that’s why all our communications now is distant, through phone or internet. ... We can communicate and I’m able to provide some recommendations for changes in treatment or some corrections in insulin therapy.”

Despite the Russians closing in on Kyiv, Dr. Mankovsky said, “I’ve decided to stay as long as possible. Then, nobody knows of course but I think I have to. ... We hear explosions every day. ... I’m in the center of the city and the streets are empty. It’s heartbreaking.”
 

Supplies are reaching refugees

Dr. Mankovsky said: “Now we have huge movement of refugees. Among them are a lot of people with diabetes who moved out of their place and nobody knows where they are. It’s really a huge disruption.”

According to the type 1 diabetes advocacy organization JDRF, many men with diabetes aged 18-60 are remaining in Ukraine to fight, despite the increased risk with the disease. But an estimated 15,000 children with type 1 diabetes and their families are attempting to escape the conflict by moving to the western regions of the country or over the borders.

“Those who make it to Hungary, Moldova, Poland, or Romania are being received with wonderful generosity. We have heard stories ranging from governments making it possible to pick up insulin free without a script to individuals emptying their cupboards of insulin for those whose need is urgent,” JDRF said in a statement on March 2.  

For its part, Novo Nordisk has donated 55 million Danish kroner (about 7.3 million Euros, or $8.2 million U.S. dollars) to support international relief organizations in assisting refugees.

Ivan Tkac, MD, PhD, professor of medicine at Safárik University in Kosice, Slovakia, is assisting refugees, including those with diabetes. Slovakia is predominantly a transit country for refugees from Ukraine, he said in an interview. 

“However, in solidarity with Ukraine, we are providing emergency medical care for both Ukrainians and refugees from third countries leaving Ukraine,” he said, noting that those individuals are primarily foreign students who had been studying there.

“Asylum seekers receive full medical insurance paid by the government of the Slovak Republic. As part of this care, the refugees are provided with the necessary amount of insulin and other antidiabetic drugs, as well as medical devices needed for the treatment of diabetes. The European Commission has pledged to supply Slovakia with the necessary quantities of medicines for the treatment of diabetes in the coming weeks as part of its assistance to the countries bordering Ukraine. In addition, some humanitarian organizations are organizing supplies of insulin and other medicines for soldiers fighting in the Ukrainian army,” Dr. Tkac said.
 

How you can help

A number of organizations are providing assistance specifically to people with diabetes, as well as broader medical assistance to people remaining in Ukraine and to refugees.

A collaboration between the Ministry of Health of Ukraine, the humanitarian agency Direct Relief, and the International Diabetes Federation is working to determine where supplies are short, to secure donations within Europe, and to open up “green corridors” within Ukraine to deliver them quickly to where they’re needed. They have asked those who wish to help to donate to Direct Relief and direct donations to the “Ukraine crisis.”

Another effort organized by IDF Europe is Connect Solidarity, a program that “aims to facilitate support from IDF Europe member associations across Europe wishing to help other national diabetes associations in Ukraine’s neighboring countries, provide advice, medicines, and supplies to Ukrainian refugees.”

IDF President Andrew Boulton, MD, told this news organization that he has been in almost daily contact with senior colleagues working in diabetes in Ukraine, and that he is working with the organization’s affiliated charity Life for a Child in addition to the other charitable agencies. “We will continue to do our utmost best to help those with diabetes living in Ukraine. However, this is, of course, very challenging, and we hope that we are doing the best we can in such a difficult situation. We all hope and pray that this situation is soon resolved.”

The European Association for the Study of Diabetes is taking a somewhat different approach, by encouraging its members to “support people with ill health, including diabetes, with donations through established [nongovernmental organizations] that have the capacity to help on site, such as United Nations High Commissioner for Refugees or International Committee of the Red Cross.”

Dr. Mankovsky told this news organization that he is very grateful for all the support from around the world: “Just thanks. I’ve got so much support, so many phone calls, so many letters ... not just me, all of us. People wise and friendship wise we feel support. It’s really important, emotionally and with insulin supply and other medications. Without that, it would be much more difficult.”
 

Pandemic-prompted changes enable wartime diabetes care

Dramatic changes in diabetes care delivery in Ukraine necessitated by the COVID-19 pandemic have proved indispensable during the Russian invasion.

In a piece published May 29, 2020, in the Journal of Diabetes Science and Technology, Dr. Mankovsky described how the pandemic hit just as Ukraine’s health system was pivoting from government controlled to insurance based.

Prior to the pandemic, patients with both type 1 and type 2 diabetes were regularly admitted to hospital for routine checkups, insulin dose management, and other treatments, a “remnant of the Soviet-era medical practice, which emphasized heavily on hospital admissions,” Dr. Mankovsky said in an interview.

This was the case, he wrote in the article, “despite the common understanding that such a system was a waste of resources ... this policy was changing much slower than we wanted.”

But the COVID-19 pandemic changed that practice “abruptly and dramatically,” so that all hospitalizations for patients with diabetes were stopped unless there was a real metabolic emergency.

Subsequently, Dr. Mankovsky wrote, “almost every health professional recognizes the particular importance of the new ways of communications with patients and with other colleagues.”

Indeed, in his email to this news organization, Dr. Smirnov mentioned that the routine diabetes management work he is still able to do remotely despite the extreme disruption in his region “is easy because of long-term COVID-period experience.”

Also because of the pandemic, insulin prescriptions were switched from traditional paper to electronic transfer, so that patients could easily pick them up at the pharmacy. “This new ... system proved to be not just very convenient for all parties involved, but in the current situation, it allowed us to prevent so many medically unnecessary visits to the clinics, which otherwise would have presented the real threat to the patients’ health and risk to get them infected,” Dr. Mankovsky wrote in 2020.

Now with the new danger, he said, “the inability to see patients is probably the least of our problems.”

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

Diabetes care and access to insulin and other medications in Ukraine have been “severely disrupted” since Russia’s invasion, with shortages resulting more from distribution problems than supply itself, according to multiple sources.

In 2021, there were about 2.3 million people with diabetes in Ukraine, roughly 7% of the total population. Of those, about 120,000 have type 1 diabetes and depend on insulin to live, while a similar number have insulin-treated type 2 diabetes.

Donations of insulin, other medications, and supplies have been pouring in since late February from sources including the Ukrainian diaspora, nongovernmental organizations, other European governments, universities, and product manufacturers. “The main problem now is logistic,” Boris Mankovsky, MD, president of the Ukrainian Diabetology Association, said in an interview.

Insulin manufacturer Novo Nordisk’s warehouse continues to operate, although deliveries have been curtailed because of shortages in delivery staff. The company is working to get medications to patients either through pharmacies or humanitarian organizations and has funded refugee support efforts, they said in a March 8 statement.

But even if the supplies reach the pharmacies, they may not reach patients for a variety of logistical reasons, noted Dr. Mankovsky, who is head of the department of diabetology at the P.L. Shupyk National Medical Academy for Postgraduate Education in Kyiv. “So, there are a lot of problems. I don’t know exactly where the main bottleneck is, but there are shortages, definitely.”

Insulin supplies have also been distributed very unequally by region and type, with various shipments containing long-acting, short-acting, analog, or human insulins. “We’re very grateful for all of it. But it’s not centrally coordinated, which of course is understandable, but it means that a lot of donations go to one place and no supply goes to another,” Dr. Mankovsky said.

Most of the donated supplies have been going to western Ukraine, where the capital Kyiv is located. “But the main problem now is the eastern part of Ukraine. It’s difficult and dangerous to deliver any supplies there, especially [with] the terrible situation in Mariupol. Eastern Ukraine now suffers the most, at least at this minute,” he said.  
 

Diabetes specialists continue to work, at least for now  

Ivan Smirnov, MD, PhD, head of the endocrinology department at Kharkiv Regional Hospital, in the northeastern part of the country, said in an email to this news organization: “I continue to stay in Kharkiv, in spite of the situation. A lot of people are killed, many people are wounded. My hospital is full of wounded civilians ... a lot of buildings are destroyed partly and some completely.”

Dr. Smirnov said that he and his colleagues “find the way to overcome the fear ... in constant work. Part of the work is online consulting assistance for routine patients. ... But the main time now is dedicated to providing the diabetes patients with insulin. This is a heavy job to do indeed.”

Dr. Mankovsky, who practices adult diabetology and endocrinology in Kyiv, continues to manage patients, but mostly remotely. “Practice is severely disrupted. I’m willing to see patients but it’s extremely difficult and dangerous for them and probably not possible to travel to see me. So that’s why all our communications now is distant, through phone or internet. ... We can communicate and I’m able to provide some recommendations for changes in treatment or some corrections in insulin therapy.”

Despite the Russians closing in on Kyiv, Dr. Mankovsky said, “I’ve decided to stay as long as possible. Then, nobody knows of course but I think I have to. ... We hear explosions every day. ... I’m in the center of the city and the streets are empty. It’s heartbreaking.”
 

Supplies are reaching refugees

Dr. Mankovsky said: “Now we have huge movement of refugees. Among them are a lot of people with diabetes who moved out of their place and nobody knows where they are. It’s really a huge disruption.”

According to the type 1 diabetes advocacy organization JDRF, many men with diabetes aged 18-60 are remaining in Ukraine to fight, despite the increased risk with the disease. But an estimated 15,000 children with type 1 diabetes and their families are attempting to escape the conflict by moving to the western regions of the country or over the borders.

“Those who make it to Hungary, Moldova, Poland, or Romania are being received with wonderful generosity. We have heard stories ranging from governments making it possible to pick up insulin free without a script to individuals emptying their cupboards of insulin for those whose need is urgent,” JDRF said in a statement on March 2.  

For its part, Novo Nordisk has donated 55 million Danish kroner (about 7.3 million Euros, or $8.2 million U.S. dollars) to support international relief organizations in assisting refugees.

Ivan Tkac, MD, PhD, professor of medicine at Safárik University in Kosice, Slovakia, is assisting refugees, including those with diabetes. Slovakia is predominantly a transit country for refugees from Ukraine, he said in an interview. 

“However, in solidarity with Ukraine, we are providing emergency medical care for both Ukrainians and refugees from third countries leaving Ukraine,” he said, noting that those individuals are primarily foreign students who had been studying there.

“Asylum seekers receive full medical insurance paid by the government of the Slovak Republic. As part of this care, the refugees are provided with the necessary amount of insulin and other antidiabetic drugs, as well as medical devices needed for the treatment of diabetes. The European Commission has pledged to supply Slovakia with the necessary quantities of medicines for the treatment of diabetes in the coming weeks as part of its assistance to the countries bordering Ukraine. In addition, some humanitarian organizations are organizing supplies of insulin and other medicines for soldiers fighting in the Ukrainian army,” Dr. Tkac said.
 

How you can help

A number of organizations are providing assistance specifically to people with diabetes, as well as broader medical assistance to people remaining in Ukraine and to refugees.

A collaboration between the Ministry of Health of Ukraine, the humanitarian agency Direct Relief, and the International Diabetes Federation is working to determine where supplies are short, to secure donations within Europe, and to open up “green corridors” within Ukraine to deliver them quickly to where they’re needed. They have asked those who wish to help to donate to Direct Relief and direct donations to the “Ukraine crisis.”

Another effort organized by IDF Europe is Connect Solidarity, a program that “aims to facilitate support from IDF Europe member associations across Europe wishing to help other national diabetes associations in Ukraine’s neighboring countries, provide advice, medicines, and supplies to Ukrainian refugees.”

IDF President Andrew Boulton, MD, told this news organization that he has been in almost daily contact with senior colleagues working in diabetes in Ukraine, and that he is working with the organization’s affiliated charity Life for a Child in addition to the other charitable agencies. “We will continue to do our utmost best to help those with diabetes living in Ukraine. However, this is, of course, very challenging, and we hope that we are doing the best we can in such a difficult situation. We all hope and pray that this situation is soon resolved.”

The European Association for the Study of Diabetes is taking a somewhat different approach, by encouraging its members to “support people with ill health, including diabetes, with donations through established [nongovernmental organizations] that have the capacity to help on site, such as United Nations High Commissioner for Refugees or International Committee of the Red Cross.”

Dr. Mankovsky told this news organization that he is very grateful for all the support from around the world: “Just thanks. I’ve got so much support, so many phone calls, so many letters ... not just me, all of us. People wise and friendship wise we feel support. It’s really important, emotionally and with insulin supply and other medications. Without that, it would be much more difficult.”
 

Pandemic-prompted changes enable wartime diabetes care

Dramatic changes in diabetes care delivery in Ukraine necessitated by the COVID-19 pandemic have proved indispensable during the Russian invasion.

In a piece published May 29, 2020, in the Journal of Diabetes Science and Technology, Dr. Mankovsky described how the pandemic hit just as Ukraine’s health system was pivoting from government controlled to insurance based.

Prior to the pandemic, patients with both type 1 and type 2 diabetes were regularly admitted to hospital for routine checkups, insulin dose management, and other treatments, a “remnant of the Soviet-era medical practice, which emphasized heavily on hospital admissions,” Dr. Mankovsky said in an interview.

This was the case, he wrote in the article, “despite the common understanding that such a system was a waste of resources ... this policy was changing much slower than we wanted.”

But the COVID-19 pandemic changed that practice “abruptly and dramatically,” so that all hospitalizations for patients with diabetes were stopped unless there was a real metabolic emergency.

Subsequently, Dr. Mankovsky wrote, “almost every health professional recognizes the particular importance of the new ways of communications with patients and with other colleagues.”

Indeed, in his email to this news organization, Dr. Smirnov mentioned that the routine diabetes management work he is still able to do remotely despite the extreme disruption in his region “is easy because of long-term COVID-period experience.”

Also because of the pandemic, insulin prescriptions were switched from traditional paper to electronic transfer, so that patients could easily pick them up at the pharmacy. “This new ... system proved to be not just very convenient for all parties involved, but in the current situation, it allowed us to prevent so many medically unnecessary visits to the clinics, which otherwise would have presented the real threat to the patients’ health and risk to get them infected,” Dr. Mankovsky wrote in 2020.

Now with the new danger, he said, “the inability to see patients is probably the least of our problems.”

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

As public attention continues to focus on making insulin affordable, a new online guide is available to help clinicians approach discussions with patients about diabetes medication affordability and access.

The resource, “Having Healthcare Cost Conversations to Improve Patient Outcomes: A Practical Guide,” was jointly developed by the Association of Diabetes Care & Education Specialists and Beyond Type 1, the nonprofit patient advocacy organization.

Indeed, the guide appeared as President Biden discussed his proposal to cap insulin costs at $35 per insulin vial during the State of the Union address, during which he introduced a young boy with type 1 diabetes in the guest box, as reported by this news organization. On March 3, Civica, a nonprofit coalition of health systems and philanthropies, announced it plans to manufacture generic insulin at a deeply discounted price, as reported by this news organization.

“Just to see diabetes front and center at the State of the Union followed by these announcements is certainly reflective of our own advocacy effort to make sure that people have affordable options for insulin, diabetes medications, services,” Kate Thomas, ADCES chief advocacy and external affairs officer, said in an interview. She added that ADCES has also pushed for legislation in Congress that would expand access to diabetes self-management training under the Medicare program.

The guide includes advice about overcoming barriers to discussing treatment costs with patients, suggested questions to ask patients about specific costs, and determinants of health and conversational approaches. Links are provided to resources for obtaining affordable insulin, other diabetes medications, and continuous glucose monitoring and insulin pump equipment.

“We know that, especially during primary care visits, there is limited time along with numbers of issues to talk about, so I think our challenge is how do we prioritize these conversations with something that can lead to action, not just saying you should do this but how do you actually do it,” Ms. Thomas said.

The introduction summarizes results from a 2021 Beyond Type 1 survey confirming prior findings reported by this news organization that cost is a frequent barrier for many individuals living with diabetes. “Especially right now where we are in terms of the impact of the pandemic and with peoples’ job statuses changing, I think it’s worthwhile to raise this in patient encounters,” Ms. Thomas said.
 

Overcoming conversational barriers

The first of three tables in the guide provides a list of “barriers to having a cost conversation” in the first column and “suggested solutions” in the second. For example, for the barrier, “You have insufficient time and/or knowledge about cost,” the suggestion is, “request and share available faculty and resources, including benefits coordinators, social workers, and community-based organizations. Work with the pharmacists and other members of the diabetes care team to identify resources that lower cost of medications.”

And for another barrier, “patients are often embarrassed or ashamed to initiate discussions of affordability,” the suggested solution is: “Normalize the issue of cost of care barriers for patients.”

A second table offers specific questions to ask patients about costs of medications and care, determinants of health, and financial barriers. These include: “What are some challenges you’ve had to accessing your medications or taking them as prescribed? What are some out-of-pocket health care costs you need help with? What challenges do you have accessing healthy food for you and your family?”

A link to a screening tool for social determinants of health is also included.

Language suggestions include talking about “cost of care” rather than “money,” asking patients if they’ve understood everything correctly by repeating back what they’ve said, and asking for confirmation and discussing follow-up.

Overall, the tool is designed to be a “broad conversation starter,” and not just about medications, Ms. Thomas said. “This is for all audiences and it’s meant to be something that the provider can tailor depending on who they’re speaking to. ... It’s about medications, but also the entire cost of care, including services and devices, transportation to appointments, access to food. ... Diabetes care isn’t just taking medication. It’s so many more factors.”

Ms. Thomas reported no relevant financial relationships.

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

As public attention continues to focus on making insulin affordable, a new online guide is available to help clinicians approach discussions with patients about diabetes medication affordability and access.

The resource, “Having Healthcare Cost Conversations to Improve Patient Outcomes: A Practical Guide,” was jointly developed by the Association of Diabetes Care & Education Specialists and Beyond Type 1, the nonprofit patient advocacy organization.

Indeed, the guide appeared as President Biden discussed his proposal to cap insulin costs at $35 per insulin vial during the State of the Union address, during which he introduced a young boy with type 1 diabetes in the guest box, as reported by this news organization. On March 3, Civica, a nonprofit coalition of health systems and philanthropies, announced it plans to manufacture generic insulin at a deeply discounted price, as reported by this news organization.

“Just to see diabetes front and center at the State of the Union followed by these announcements is certainly reflective of our own advocacy effort to make sure that people have affordable options for insulin, diabetes medications, services,” Kate Thomas, ADCES chief advocacy and external affairs officer, said in an interview. She added that ADCES has also pushed for legislation in Congress that would expand access to diabetes self-management training under the Medicare program.

The guide includes advice about overcoming barriers to discussing treatment costs with patients, suggested questions to ask patients about specific costs, and determinants of health and conversational approaches. Links are provided to resources for obtaining affordable insulin, other diabetes medications, and continuous glucose monitoring and insulin pump equipment.

“We know that, especially during primary care visits, there is limited time along with numbers of issues to talk about, so I think our challenge is how do we prioritize these conversations with something that can lead to action, not just saying you should do this but how do you actually do it,” Ms. Thomas said.

The introduction summarizes results from a 2021 Beyond Type 1 survey confirming prior findings reported by this news organization that cost is a frequent barrier for many individuals living with diabetes. “Especially right now where we are in terms of the impact of the pandemic and with peoples’ job statuses changing, I think it’s worthwhile to raise this in patient encounters,” Ms. Thomas said.
 

Overcoming conversational barriers

The first of three tables in the guide provides a list of “barriers to having a cost conversation” in the first column and “suggested solutions” in the second. For example, for the barrier, “You have insufficient time and/or knowledge about cost,” the suggestion is, “request and share available faculty and resources, including benefits coordinators, social workers, and community-based organizations. Work with the pharmacists and other members of the diabetes care team to identify resources that lower cost of medications.”

And for another barrier, “patients are often embarrassed or ashamed to initiate discussions of affordability,” the suggested solution is: “Normalize the issue of cost of care barriers for patients.”

A second table offers specific questions to ask patients about costs of medications and care, determinants of health, and financial barriers. These include: “What are some challenges you’ve had to accessing your medications or taking them as prescribed? What are some out-of-pocket health care costs you need help with? What challenges do you have accessing healthy food for you and your family?”

A link to a screening tool for social determinants of health is also included.

Language suggestions include talking about “cost of care” rather than “money,” asking patients if they’ve understood everything correctly by repeating back what they’ve said, and asking for confirmation and discussing follow-up.

Overall, the tool is designed to be a “broad conversation starter,” and not just about medications, Ms. Thomas said. “This is for all audiences and it’s meant to be something that the provider can tailor depending on who they’re speaking to. ... It’s about medications, but also the entire cost of care, including services and devices, transportation to appointments, access to food. ... Diabetes care isn’t just taking medication. It’s so many more factors.”

Ms. Thomas reported no relevant financial relationships.

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

As public attention continues to focus on making insulin affordable, a new online guide is available to help clinicians approach discussions with patients about diabetes medication affordability and access.

The resource, “Having Healthcare Cost Conversations to Improve Patient Outcomes: A Practical Guide,” was jointly developed by the Association of Diabetes Care & Education Specialists and Beyond Type 1, the nonprofit patient advocacy organization.

Indeed, the guide appeared as President Biden discussed his proposal to cap insulin costs at $35 per insulin vial during the State of the Union address, during which he introduced a young boy with type 1 diabetes in the guest box, as reported by this news organization. On March 3, Civica, a nonprofit coalition of health systems and philanthropies, announced it plans to manufacture generic insulin at a deeply discounted price, as reported by this news organization.

“Just to see diabetes front and center at the State of the Union followed by these announcements is certainly reflective of our own advocacy effort to make sure that people have affordable options for insulin, diabetes medications, services,” Kate Thomas, ADCES chief advocacy and external affairs officer, said in an interview. She added that ADCES has also pushed for legislation in Congress that would expand access to diabetes self-management training under the Medicare program.

The guide includes advice about overcoming barriers to discussing treatment costs with patients, suggested questions to ask patients about specific costs, and determinants of health and conversational approaches. Links are provided to resources for obtaining affordable insulin, other diabetes medications, and continuous glucose monitoring and insulin pump equipment.

“We know that, especially during primary care visits, there is limited time along with numbers of issues to talk about, so I think our challenge is how do we prioritize these conversations with something that can lead to action, not just saying you should do this but how do you actually do it,” Ms. Thomas said.

The introduction summarizes results from a 2021 Beyond Type 1 survey confirming prior findings reported by this news organization that cost is a frequent barrier for many individuals living with diabetes. “Especially right now where we are in terms of the impact of the pandemic and with peoples’ job statuses changing, I think it’s worthwhile to raise this in patient encounters,” Ms. Thomas said.
 

Overcoming conversational barriers

The first of three tables in the guide provides a list of “barriers to having a cost conversation” in the first column and “suggested solutions” in the second. For example, for the barrier, “You have insufficient time and/or knowledge about cost,” the suggestion is, “request and share available faculty and resources, including benefits coordinators, social workers, and community-based organizations. Work with the pharmacists and other members of the diabetes care team to identify resources that lower cost of medications.”

And for another barrier, “patients are often embarrassed or ashamed to initiate discussions of affordability,” the suggested solution is: “Normalize the issue of cost of care barriers for patients.”

A second table offers specific questions to ask patients about costs of medications and care, determinants of health, and financial barriers. These include: “What are some challenges you’ve had to accessing your medications or taking them as prescribed? What are some out-of-pocket health care costs you need help with? What challenges do you have accessing healthy food for you and your family?”

A link to a screening tool for social determinants of health is also included.

Language suggestions include talking about “cost of care” rather than “money,” asking patients if they’ve understood everything correctly by repeating back what they’ve said, and asking for confirmation and discussing follow-up.

Overall, the tool is designed to be a “broad conversation starter,” and not just about medications, Ms. Thomas said. “This is for all audiences and it’s meant to be something that the provider can tailor depending on who they’re speaking to. ... It’s about medications, but also the entire cost of care, including services and devices, transportation to appointments, access to food. ... Diabetes care isn’t just taking medication. It’s so many more factors.”

Ms. Thomas reported no relevant financial relationships.

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

Patients with low-risk differentiated thyroid cancer (DTC) undergoing thyroidectomy show no improvements in outcomes with the use of postoperative radioiodine ablation compared to those who do not receive this therapy, suggesting these patients can be spared the previously common treatment.

The study’s take-home message for clinicians should be to “stop systematic radioiodine ablation administration in low-risk thyroid cancer patients,” lead author Sophie Leboulleux, MD, PhD, said in an interview.

The results were first reported at ENDO 2021 and have now been published in the New England Journal of Medicine by Dr. Leboulleux, of the department of nuclear medicine and endocrine oncology, Gustave Roussy Cancer Institute, Villejuif, France, and colleagues.

While American Thyroid Association (ATA) guidelines already indicate that radioiodine ablation is not routinely recommended after thyroidectomy for patients with low-risk thyroid cancer, the guidance is only a “weak recommendation,” supported by “low-quality evidence.”  

However, the new findings should give that level of evidence a much-needed boost, said one expert. “I think the main contribution of this paper is to change the evidence level to ‘high quality,’ therefore making the recommendation ‘strong,’ rather than ‘weak,’ ” David S. Cooper, MD, said in an interview.

Dr. Cooper, professor of medicine and radiology at Johns Hopkins University, Baltimore, wrote an editorial that accompanies Dr. Leboulleux’s study.

The ability to safely spare patients the radioiodine ablation step after thyroidectomy has important benefits in terms of cost and convenience, Dr. Cooper stressed.
 

ESTIMABL2 trial

The new findings are from the prospective, randomized, phase 3 Essai Stimulation Ablation 2 (ESTIMABL2) trial, in which 730 patients at 35 centers in France with low-risk DTC scheduled to undergo thyroidectomy were enrolled between May 2013 and March 2017.

Patients were randomized to receive either postoperative radioiodine ablation (1.1 GBq) after injections of recombinant human thyrotropin (n = 363) or no postoperative radioiodine (n = 367).

Patients were a mean age of 52 years and 83% were women. About 96% had papillary tumors, and pathological tumor node (pTN) stages were mostly pT1b thyroid with a nodal status of N0 or Nx (81.1%). It is these patients in particular in whom retrospective studies of the use of radioiodine ablation have yielded inconsistent results, Dr. Leboulleux and colleagues noted. Hence, their decision to look at this prospectively.

Outcomes were based on the groups’ rates of events, defined as the presence of abnormal foci of radioiodine uptake on whole-body scanning that required treatment (in the radioiodine group only), abnormal findings on neck ultrasonography, or increased levels of thyroglobulin or thyroglobulin antibodies.

After a 3-year follow-up, the rates of having no events in both groups were very high – and nearly identical – at 95.6% among those receiving no radioiodine ablation and 95.9% in the radioiodine group, for a between-group difference of –0.3 percentage points, which met the criteria for noninferiority for the no-radioiodine group.

Likewise, the events that did occur were nearly equally split between the no-radioiodine group (16 events, 4.4%) and the radioiodine group (15 events, 4.1%).

Among patients who had events, subsequent treatments, including surgery, radioiodine administration, or both, were necessary for four patients in the no-radioiodine group and 10 in the radioiodine group, and additional treatments were not necessary for the other patients who experienced events.

There were no differences between those who did and did not experience events in terms of molecular alterations, and 50 of the tumors had BRAF mutations, with no significant differences between groups.

Of the adverse events that occurred in 30 patients, none were determined to be related to treatment, and there were no thyroid-related deaths.

The recurrence rates align with the rates observed overall with low-risk thyroid cancer, the authors noted. 

“We observed that less than 5% of the patients in the two groups had events that included abnormal findings on whole-body scanning or neck ultrasonography or elevated levels of thyroglobulin or thyroglobulin antibodies during the first 3 years of follow-up,” they reported.

“This rate is concordant with the definition of low-risk thyroid cancer, and our trial showed that the risk of events was not higher in the absence of postoperative administration of radioiodine.”
 

Patients spared costs, work losses

Dr. Cooper elaborated on the advantages, for patients, of avoiding radioiodine ablation.

For one thing, the recombinant human TSH that is necessary to prepare for radioiodine therapy is very expensive, ranging from $2,000 to $3,000, with patients often having a copay, he explained.

“Patients usually have to take time off work, which is also an expense to society and to them if they don’t get paid for days that they don’t work,” Dr. Cooper added.

A possible study limitation is the question of whether 3 years is an ample follow-up period to detect events. However, Dr. Cooper said he considers the period to be sufficient.

“As the authors point out, most recurrences of thyroid cancer are detected within the first 3-5 years of initial treatment, so ... the 3-year window is still clinically relevant,” he said.

Regarding the study’s inclusion of centers only in France, Dr. Cooper added, “I do not think that this is a study limitation. There is nothing specific about the French population that would lead me to conclude that the results were not generalizable to all populations with low-risk papillary thyroid cancer.”
 

Some continue radioiodine use, but lobectomies add to decline

Despite the mounting evidence of the lack of benefit of radioiodine ablation in low-risk patients, some centers, particularly in Europe, continue the practice, which was standard in the treatment of DTC until relatively recently.

“[While] U.S. guidelines changed in 2015 in favor of no radioiodine in low-risk differentiated thyroid cancer patients, this study should help to change European guidelines,” Dr. Leboulleux said. “The results will help to change practice both in the U.S. and in Europe.”

In addition to awareness of guidelines and new evidence, another reason for the decline in radioiodine ablation for low-risk DTC is the increasing use of thyroid lobectomy, which does not involve the use of radioiodine ablation, rather than total thyroidectomy, Dr. Cooper noted.

“The [new] NEJM paper will hopefully decrease the inappropriate use of radioiodine in low-risk patients even further,” he concluded.

The study received support from the French Ministry of Health through a grant from the National Cancer Institute. The authors have reported no relevant financial relationships.

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

Patients with low-risk differentiated thyroid cancer (DTC) undergoing thyroidectomy show no improvements in outcomes with the use of postoperative radioiodine ablation compared to those who do not receive this therapy, suggesting these patients can be spared the previously common treatment.

The study’s take-home message for clinicians should be to “stop systematic radioiodine ablation administration in low-risk thyroid cancer patients,” lead author Sophie Leboulleux, MD, PhD, said in an interview.

The results were first reported at ENDO 2021 and have now been published in the New England Journal of Medicine by Dr. Leboulleux, of the department of nuclear medicine and endocrine oncology, Gustave Roussy Cancer Institute, Villejuif, France, and colleagues.

While American Thyroid Association (ATA) guidelines already indicate that radioiodine ablation is not routinely recommended after thyroidectomy for patients with low-risk thyroid cancer, the guidance is only a “weak recommendation,” supported by “low-quality evidence.”  

However, the new findings should give that level of evidence a much-needed boost, said one expert. “I think the main contribution of this paper is to change the evidence level to ‘high quality,’ therefore making the recommendation ‘strong,’ rather than ‘weak,’ ” David S. Cooper, MD, said in an interview.

Dr. Cooper, professor of medicine and radiology at Johns Hopkins University, Baltimore, wrote an editorial that accompanies Dr. Leboulleux’s study.

The ability to safely spare patients the radioiodine ablation step after thyroidectomy has important benefits in terms of cost and convenience, Dr. Cooper stressed.
 

ESTIMABL2 trial

The new findings are from the prospective, randomized, phase 3 Essai Stimulation Ablation 2 (ESTIMABL2) trial, in which 730 patients at 35 centers in France with low-risk DTC scheduled to undergo thyroidectomy were enrolled between May 2013 and March 2017.

Patients were randomized to receive either postoperative radioiodine ablation (1.1 GBq) after injections of recombinant human thyrotropin (n = 363) or no postoperative radioiodine (n = 367).

Patients were a mean age of 52 years and 83% were women. About 96% had papillary tumors, and pathological tumor node (pTN) stages were mostly pT1b thyroid with a nodal status of N0 or Nx (81.1%). It is these patients in particular in whom retrospective studies of the use of radioiodine ablation have yielded inconsistent results, Dr. Leboulleux and colleagues noted. Hence, their decision to look at this prospectively.

Outcomes were based on the groups’ rates of events, defined as the presence of abnormal foci of radioiodine uptake on whole-body scanning that required treatment (in the radioiodine group only), abnormal findings on neck ultrasonography, or increased levels of thyroglobulin or thyroglobulin antibodies.

After a 3-year follow-up, the rates of having no events in both groups were very high – and nearly identical – at 95.6% among those receiving no radioiodine ablation and 95.9% in the radioiodine group, for a between-group difference of –0.3 percentage points, which met the criteria for noninferiority for the no-radioiodine group.

Likewise, the events that did occur were nearly equally split between the no-radioiodine group (16 events, 4.4%) and the radioiodine group (15 events, 4.1%).

Among patients who had events, subsequent treatments, including surgery, radioiodine administration, or both, were necessary for four patients in the no-radioiodine group and 10 in the radioiodine group, and additional treatments were not necessary for the other patients who experienced events.

There were no differences between those who did and did not experience events in terms of molecular alterations, and 50 of the tumors had BRAF mutations, with no significant differences between groups.

Of the adverse events that occurred in 30 patients, none were determined to be related to treatment, and there were no thyroid-related deaths.

The recurrence rates align with the rates observed overall with low-risk thyroid cancer, the authors noted. 

“We observed that less than 5% of the patients in the two groups had events that included abnormal findings on whole-body scanning or neck ultrasonography or elevated levels of thyroglobulin or thyroglobulin antibodies during the first 3 years of follow-up,” they reported.

“This rate is concordant with the definition of low-risk thyroid cancer, and our trial showed that the risk of events was not higher in the absence of postoperative administration of radioiodine.”
 

Patients spared costs, work losses

Dr. Cooper elaborated on the advantages, for patients, of avoiding radioiodine ablation.

For one thing, the recombinant human TSH that is necessary to prepare for radioiodine therapy is very expensive, ranging from $2,000 to $3,000, with patients often having a copay, he explained.

“Patients usually have to take time off work, which is also an expense to society and to them if they don’t get paid for days that they don’t work,” Dr. Cooper added.

A possible study limitation is the question of whether 3 years is an ample follow-up period to detect events. However, Dr. Cooper said he considers the period to be sufficient.

“As the authors point out, most recurrences of thyroid cancer are detected within the first 3-5 years of initial treatment, so ... the 3-year window is still clinically relevant,” he said.

Regarding the study’s inclusion of centers only in France, Dr. Cooper added, “I do not think that this is a study limitation. There is nothing specific about the French population that would lead me to conclude that the results were not generalizable to all populations with low-risk papillary thyroid cancer.”
 

Some continue radioiodine use, but lobectomies add to decline

Despite the mounting evidence of the lack of benefit of radioiodine ablation in low-risk patients, some centers, particularly in Europe, continue the practice, which was standard in the treatment of DTC until relatively recently.

“[While] U.S. guidelines changed in 2015 in favor of no radioiodine in low-risk differentiated thyroid cancer patients, this study should help to change European guidelines,” Dr. Leboulleux said. “The results will help to change practice both in the U.S. and in Europe.”

In addition to awareness of guidelines and new evidence, another reason for the decline in radioiodine ablation for low-risk DTC is the increasing use of thyroid lobectomy, which does not involve the use of radioiodine ablation, rather than total thyroidectomy, Dr. Cooper noted.

“The [new] NEJM paper will hopefully decrease the inappropriate use of radioiodine in low-risk patients even further,” he concluded.

The study received support from the French Ministry of Health through a grant from the National Cancer Institute. The authors have reported no relevant financial relationships.

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

Patients with low-risk differentiated thyroid cancer (DTC) undergoing thyroidectomy show no improvements in outcomes with the use of postoperative radioiodine ablation compared to those who do not receive this therapy, suggesting these patients can be spared the previously common treatment.

The study’s take-home message for clinicians should be to “stop systematic radioiodine ablation administration in low-risk thyroid cancer patients,” lead author Sophie Leboulleux, MD, PhD, said in an interview.

The results were first reported at ENDO 2021 and have now been published in the New England Journal of Medicine by Dr. Leboulleux, of the department of nuclear medicine and endocrine oncology, Gustave Roussy Cancer Institute, Villejuif, France, and colleagues.

While American Thyroid Association (ATA) guidelines already indicate that radioiodine ablation is not routinely recommended after thyroidectomy for patients with low-risk thyroid cancer, the guidance is only a “weak recommendation,” supported by “low-quality evidence.”  

However, the new findings should give that level of evidence a much-needed boost, said one expert. “I think the main contribution of this paper is to change the evidence level to ‘high quality,’ therefore making the recommendation ‘strong,’ rather than ‘weak,’ ” David S. Cooper, MD, said in an interview.

Dr. Cooper, professor of medicine and radiology at Johns Hopkins University, Baltimore, wrote an editorial that accompanies Dr. Leboulleux’s study.

The ability to safely spare patients the radioiodine ablation step after thyroidectomy has important benefits in terms of cost and convenience, Dr. Cooper stressed.
 

ESTIMABL2 trial

The new findings are from the prospective, randomized, phase 3 Essai Stimulation Ablation 2 (ESTIMABL2) trial, in which 730 patients at 35 centers in France with low-risk DTC scheduled to undergo thyroidectomy were enrolled between May 2013 and March 2017.

Patients were randomized to receive either postoperative radioiodine ablation (1.1 GBq) after injections of recombinant human thyrotropin (n = 363) or no postoperative radioiodine (n = 367).

Patients were a mean age of 52 years and 83% were women. About 96% had papillary tumors, and pathological tumor node (pTN) stages were mostly pT1b thyroid with a nodal status of N0 or Nx (81.1%). It is these patients in particular in whom retrospective studies of the use of radioiodine ablation have yielded inconsistent results, Dr. Leboulleux and colleagues noted. Hence, their decision to look at this prospectively.

Outcomes were based on the groups’ rates of events, defined as the presence of abnormal foci of radioiodine uptake on whole-body scanning that required treatment (in the radioiodine group only), abnormal findings on neck ultrasonography, or increased levels of thyroglobulin or thyroglobulin antibodies.

After a 3-year follow-up, the rates of having no events in both groups were very high – and nearly identical – at 95.6% among those receiving no radioiodine ablation and 95.9% in the radioiodine group, for a between-group difference of –0.3 percentage points, which met the criteria for noninferiority for the no-radioiodine group.

Likewise, the events that did occur were nearly equally split between the no-radioiodine group (16 events, 4.4%) and the radioiodine group (15 events, 4.1%).

Among patients who had events, subsequent treatments, including surgery, radioiodine administration, or both, were necessary for four patients in the no-radioiodine group and 10 in the radioiodine group, and additional treatments were not necessary for the other patients who experienced events.

There were no differences between those who did and did not experience events in terms of molecular alterations, and 50 of the tumors had BRAF mutations, with no significant differences between groups.

Of the adverse events that occurred in 30 patients, none were determined to be related to treatment, and there were no thyroid-related deaths.

The recurrence rates align with the rates observed overall with low-risk thyroid cancer, the authors noted. 

“We observed that less than 5% of the patients in the two groups had events that included abnormal findings on whole-body scanning or neck ultrasonography or elevated levels of thyroglobulin or thyroglobulin antibodies during the first 3 years of follow-up,” they reported.

“This rate is concordant with the definition of low-risk thyroid cancer, and our trial showed that the risk of events was not higher in the absence of postoperative administration of radioiodine.”
 

Patients spared costs, work losses

Dr. Cooper elaborated on the advantages, for patients, of avoiding radioiodine ablation.

For one thing, the recombinant human TSH that is necessary to prepare for radioiodine therapy is very expensive, ranging from $2,000 to $3,000, with patients often having a copay, he explained.

“Patients usually have to take time off work, which is also an expense to society and to them if they don’t get paid for days that they don’t work,” Dr. Cooper added.

A possible study limitation is the question of whether 3 years is an ample follow-up period to detect events. However, Dr. Cooper said he considers the period to be sufficient.

“As the authors point out, most recurrences of thyroid cancer are detected within the first 3-5 years of initial treatment, so ... the 3-year window is still clinically relevant,” he said.

Regarding the study’s inclusion of centers only in France, Dr. Cooper added, “I do not think that this is a study limitation. There is nothing specific about the French population that would lead me to conclude that the results were not generalizable to all populations with low-risk papillary thyroid cancer.”
 

Some continue radioiodine use, but lobectomies add to decline

Despite the mounting evidence of the lack of benefit of radioiodine ablation in low-risk patients, some centers, particularly in Europe, continue the practice, which was standard in the treatment of DTC until relatively recently.

“[While] U.S. guidelines changed in 2015 in favor of no radioiodine in low-risk differentiated thyroid cancer patients, this study should help to change European guidelines,” Dr. Leboulleux said. “The results will help to change practice both in the U.S. and in Europe.”

In addition to awareness of guidelines and new evidence, another reason for the decline in radioiodine ablation for low-risk DTC is the increasing use of thyroid lobectomy, which does not involve the use of radioiodine ablation, rather than total thyroidectomy, Dr. Cooper noted.

“The [new] NEJM paper will hopefully decrease the inappropriate use of radioiodine in low-risk patients even further,” he concluded.

The study received support from the French Ministry of Health through a grant from the National Cancer Institute. The authors have reported no relevant financial relationships.

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

Drink a day could age your brain

There are many things we can do daily to improve our health: Exercise, read a book, eat an apple (supposedly). Not drink a glass of red wine. Wait, not drink? That’s right. We were told that a glass of red wine each night was doing something good for our hearts, but it’s doing something bad to our brains: Aging them prematurely.

According to a recent study in Nature Communications, drinking half a pint of beer a day could age the brain of a 50-year-old by 6 months. A pint of beer equaled 2 years of aging and a pint and a half aged participants’ brains by 3.5 years.

Courtesy Debora Cartagena, USCDCP

Compared with people who didn’t drink, those who averaged about two pints of beer or two glasses of wine daily had brains aged 10 years older!

The researchers’ analysis included MRI scans of about 37,000 middle-aged men in the United Kingdom, along with their medical information and drinking habits, Everyday Health reported. They determined volume reductions in two parts of the brain potentially impacted by daily consumption of alcohol: White matter, which controls the senses and communication, and gray matter, which controls cognitive functions such as movement, emotions, and memories.

Normal brain aging is bad enough: Stuff like forgetting why we walked into the kitchen or having a word we want to use on the tips of our tongues. Who knew that happy hour could be speeding up the process?

Bartender, make that mimosa a virgin.
 

A big dose of meta-cine

The metaverse is big news in the tech world. For those who are less technologically inclined or haven’t thrown a few hundred dollars at a clunky virtual reality headset, the metaverse is a vaguely defined artificial reality world, brought to you by Facebo-, excuse us, Meta, where you hang out with people using a virtual avatar and do various activities, all from the comfort of your own home.

Piqsels

That’s not the most helpful definition, if we’re being honest, and that’s partially because the metaverse, as it’s being pushed by companies such as Meta, is very new and kind of a Wild West. No one really knows what it’ll be used for, but that’s not going to stop big business from pushing to secure their own corners of a new and exciting market, and that brings us to CVS, which is looking to become the first pharmacy in the metaverse.

Specifically, the company is looking to provide the entirety of its health care services – nonemergency medical care, wellness programs, nutrition advice, and counseling – to the metaverse. That makes sense. Telemedicine has become big during the pandemic, and bringing that care to the metaverse could work. Probably overcomplicated, since the sort of person who couldn’t figure out a video call to a doctor probably won’t be spending much time in the metaverse, but hey, if they can make it work, more power to them.

Where things get a bit silly is the online store. CVS looking to sell not only NFTs (because of course it is), but also downloadable virtual goods, including “prescription drugs, health, wellness, beauty, and personal care products,” according to the company’s claim to the U.S. Patent Trade Office. What exactly is a downloadable virtual prescription drug? Excellent question. We’re picturing holographic meatloaf, but the true answer is bound to be sillier than anything SpongeBob and friends could conjure.
 

Please don’t eat the winner

Hello friends. LOTME Sports welcomes you to the University of Toledo’s Glass Bowl for the wackiest virtual sporting event since Usain Bolt raced against a cheetah.

Frank_P_AJJ74/Pixabay

Hi, I’m Jim Nantz, and we’re here to witness the brainchild of Toledo physics professor Scott Lee, PhD, who posed an unusual question to his students: Is Usain Bolt faster than a 900-pound dinosaur?

Before we get started, though, I’ve got a quick question for my partner in today’s broadcast, Hall of Fame quarterback Peyton Manning: Why is someone who practices physics called a physicist when someone who practices medicine is known as a physician?

Jim, I’m prepared to talk about how Dr. Lee’s students used the concepts of 1D kinematics – displacement, speed, velocity, and acceleration – to determine if a Jamaican sprinter could beat Dilophosaurus wetherilli in a hypothetical race. Heck, it took me 2 days to be able to pronounce Dilophosaurus wetherilli. Don’t get me started on etymology.

Fair enough, my friend. What else can you tell us?

In his article in The Physics Teacher, Dr. Lee noted that recent musculoskeletal models of vertebrate animals have shown that a dinosaur like Dilophosaurus could run about as fast as Usain Bolt when he set the world record of 9.58 seconds for 100 meters in 2009. You might remember Dilophosaurus from “Jurassic Park.” It was the one that attacked the guy who played Newman on “Seinfeld.”

Fascinating stuff, Peyton, but it looks like the race is about to start. And they’re off! Newton’s second law, which says that acceleration is determined by a combination of mass and force, gives the smaller Bolt an early advantage. The dinosaur takes longer to reach maximum running velocity and crosses the line 2 seconds behind the world’s fastest human. Amazing!

Be sure to tune in again next week, when tennis legend Serena Williams takes the court against a hungry velociraptor.
 

Turning back the egg timer

The idea of getting older can be scary. Wouldn’t it be nice if we could reverse the aging process? Nice, sure, but not possible. Well, it may just be possible for women undergoing assisted reproductive treatment.

Gerd Altmann/Pixabay

It’s generally known that oocytes accumulate DNA damage over time as well, hindering fertility, but a lab in Jerusalem has found a way to reverse the age of eggs.

If you’re wondering how on Earth that was possible, here’s how. Scientists from the Hebrew University of Jerusalem said that they found a previously unknown aging mechanism, which they were able to reverse using antiviral medications, they reported in Aging Cell.

The experiment started on mice eggs, but soon real human eggs were donated. After the procedure, the treated eggs appeared younger, with less of the DNA damage that comes from age. Sperm has not yet been used to test fertility so it is unclear if this will result in something game changing, but the investigators have high hopes.

“Many women are trying to get pregnant aged 40 or over, and we think this could actually increase their level of fertility,” senior investigator Michael Klutstein, PhD, told the Times of Israel. “Within 10 years, we hope to use antiviral drugs to increase fertility among older women.”

We’re counting on you, science! Do your thing!

Drink a day could age your brain

There are many things we can do daily to improve our health: Exercise, read a book, eat an apple (supposedly). Not drink a glass of red wine. Wait, not drink? That’s right. We were told that a glass of red wine each night was doing something good for our hearts, but it’s doing something bad to our brains: Aging them prematurely.

According to a recent study in Nature Communications, drinking half a pint of beer a day could age the brain of a 50-year-old by 6 months. A pint of beer equaled 2 years of aging and a pint and a half aged participants’ brains by 3.5 years.

Courtesy Debora Cartagena, USCDCP

Compared with people who didn’t drink, those who averaged about two pints of beer or two glasses of wine daily had brains aged 10 years older!

The researchers’ analysis included MRI scans of about 37,000 middle-aged men in the United Kingdom, along with their medical information and drinking habits, Everyday Health reported. They determined volume reductions in two parts of the brain potentially impacted by daily consumption of alcohol: White matter, which controls the senses and communication, and gray matter, which controls cognitive functions such as movement, emotions, and memories.

Normal brain aging is bad enough: Stuff like forgetting why we walked into the kitchen or having a word we want to use on the tips of our tongues. Who knew that happy hour could be speeding up the process?

Bartender, make that mimosa a virgin.
 

A big dose of meta-cine

The metaverse is big news in the tech world. For those who are less technologically inclined or haven’t thrown a few hundred dollars at a clunky virtual reality headset, the metaverse is a vaguely defined artificial reality world, brought to you by Facebo-, excuse us, Meta, where you hang out with people using a virtual avatar and do various activities, all from the comfort of your own home.

Piqsels

That’s not the most helpful definition, if we’re being honest, and that’s partially because the metaverse, as it’s being pushed by companies such as Meta, is very new and kind of a Wild West. No one really knows what it’ll be used for, but that’s not going to stop big business from pushing to secure their own corners of a new and exciting market, and that brings us to CVS, which is looking to become the first pharmacy in the metaverse.

Specifically, the company is looking to provide the entirety of its health care services – nonemergency medical care, wellness programs, nutrition advice, and counseling – to the metaverse. That makes sense. Telemedicine has become big during the pandemic, and bringing that care to the metaverse could work. Probably overcomplicated, since the sort of person who couldn’t figure out a video call to a doctor probably won’t be spending much time in the metaverse, but hey, if they can make it work, more power to them.

Where things get a bit silly is the online store. CVS looking to sell not only NFTs (because of course it is), but also downloadable virtual goods, including “prescription drugs, health, wellness, beauty, and personal care products,” according to the company’s claim to the U.S. Patent Trade Office. What exactly is a downloadable virtual prescription drug? Excellent question. We’re picturing holographic meatloaf, but the true answer is bound to be sillier than anything SpongeBob and friends could conjure.
 

Please don’t eat the winner

Hello friends. LOTME Sports welcomes you to the University of Toledo’s Glass Bowl for the wackiest virtual sporting event since Usain Bolt raced against a cheetah.

Frank_P_AJJ74/Pixabay

Hi, I’m Jim Nantz, and we’re here to witness the brainchild of Toledo physics professor Scott Lee, PhD, who posed an unusual question to his students: Is Usain Bolt faster than a 900-pound dinosaur?

Before we get started, though, I’ve got a quick question for my partner in today’s broadcast, Hall of Fame quarterback Peyton Manning: Why is someone who practices physics called a physicist when someone who practices medicine is known as a physician?

Jim, I’m prepared to talk about how Dr. Lee’s students used the concepts of 1D kinematics – displacement, speed, velocity, and acceleration – to determine if a Jamaican sprinter could beat Dilophosaurus wetherilli in a hypothetical race. Heck, it took me 2 days to be able to pronounce Dilophosaurus wetherilli. Don’t get me started on etymology.

Fair enough, my friend. What else can you tell us?

In his article in The Physics Teacher, Dr. Lee noted that recent musculoskeletal models of vertebrate animals have shown that a dinosaur like Dilophosaurus could run about as fast as Usain Bolt when he set the world record of 9.58 seconds for 100 meters in 2009. You might remember Dilophosaurus from “Jurassic Park.” It was the one that attacked the guy who played Newman on “Seinfeld.”

Fascinating stuff, Peyton, but it looks like the race is about to start. And they’re off! Newton’s second law, which says that acceleration is determined by a combination of mass and force, gives the smaller Bolt an early advantage. The dinosaur takes longer to reach maximum running velocity and crosses the line 2 seconds behind the world’s fastest human. Amazing!

Be sure to tune in again next week, when tennis legend Serena Williams takes the court against a hungry velociraptor.
 

Turning back the egg timer

The idea of getting older can be scary. Wouldn’t it be nice if we could reverse the aging process? Nice, sure, but not possible. Well, it may just be possible for women undergoing assisted reproductive treatment.

Gerd Altmann/Pixabay

It’s generally known that oocytes accumulate DNA damage over time as well, hindering fertility, but a lab in Jerusalem has found a way to reverse the age of eggs.

If you’re wondering how on Earth that was possible, here’s how. Scientists from the Hebrew University of Jerusalem said that they found a previously unknown aging mechanism, which they were able to reverse using antiviral medications, they reported in Aging Cell.

The experiment started on mice eggs, but soon real human eggs were donated. After the procedure, the treated eggs appeared younger, with less of the DNA damage that comes from age. Sperm has not yet been used to test fertility so it is unclear if this will result in something game changing, but the investigators have high hopes.

“Many women are trying to get pregnant aged 40 or over, and we think this could actually increase their level of fertility,” senior investigator Michael Klutstein, PhD, told the Times of Israel. “Within 10 years, we hope to use antiviral drugs to increase fertility among older women.”

We’re counting on you, science! Do your thing!

Drink a day could age your brain

There are many things we can do daily to improve our health: Exercise, read a book, eat an apple (supposedly). Not drink a glass of red wine. Wait, not drink? That’s right. We were told that a glass of red wine each night was doing something good for our hearts, but it’s doing something bad to our brains: Aging them prematurely.

According to a recent study in Nature Communications, drinking half a pint of beer a day could age the brain of a 50-year-old by 6 months. A pint of beer equaled 2 years of aging and a pint and a half aged participants’ brains by 3.5 years.

Courtesy Debora Cartagena, USCDCP

Compared with people who didn’t drink, those who averaged about two pints of beer or two glasses of wine daily had brains aged 10 years older!

The researchers’ analysis included MRI scans of about 37,000 middle-aged men in the United Kingdom, along with their medical information and drinking habits, Everyday Health reported. They determined volume reductions in two parts of the brain potentially impacted by daily consumption of alcohol: White matter, which controls the senses and communication, and gray matter, which controls cognitive functions such as movement, emotions, and memories.

Normal brain aging is bad enough: Stuff like forgetting why we walked into the kitchen or having a word we want to use on the tips of our tongues. Who knew that happy hour could be speeding up the process?

Bartender, make that mimosa a virgin.
 

A big dose of meta-cine

The metaverse is big news in the tech world. For those who are less technologically inclined or haven’t thrown a few hundred dollars at a clunky virtual reality headset, the metaverse is a vaguely defined artificial reality world, brought to you by Facebo-, excuse us, Meta, where you hang out with people using a virtual avatar and do various activities, all from the comfort of your own home.

Piqsels

That’s not the most helpful definition, if we’re being honest, and that’s partially because the metaverse, as it’s being pushed by companies such as Meta, is very new and kind of a Wild West. No one really knows what it’ll be used for, but that’s not going to stop big business from pushing to secure their own corners of a new and exciting market, and that brings us to CVS, which is looking to become the first pharmacy in the metaverse.

Specifically, the company is looking to provide the entirety of its health care services – nonemergency medical care, wellness programs, nutrition advice, and counseling – to the metaverse. That makes sense. Telemedicine has become big during the pandemic, and bringing that care to the metaverse could work. Probably overcomplicated, since the sort of person who couldn’t figure out a video call to a doctor probably won’t be spending much time in the metaverse, but hey, if they can make it work, more power to them.

Where things get a bit silly is the online store. CVS looking to sell not only NFTs (because of course it is), but also downloadable virtual goods, including “prescription drugs, health, wellness, beauty, and personal care products,” according to the company’s claim to the U.S. Patent Trade Office. What exactly is a downloadable virtual prescription drug? Excellent question. We’re picturing holographic meatloaf, but the true answer is bound to be sillier than anything SpongeBob and friends could conjure.
 

Please don’t eat the winner

Hello friends. LOTME Sports welcomes you to the University of Toledo’s Glass Bowl for the wackiest virtual sporting event since Usain Bolt raced against a cheetah.

Frank_P_AJJ74/Pixabay

Hi, I’m Jim Nantz, and we’re here to witness the brainchild of Toledo physics professor Scott Lee, PhD, who posed an unusual question to his students: Is Usain Bolt faster than a 900-pound dinosaur?

Before we get started, though, I’ve got a quick question for my partner in today’s broadcast, Hall of Fame quarterback Peyton Manning: Why is someone who practices physics called a physicist when someone who practices medicine is known as a physician?

Jim, I’m prepared to talk about how Dr. Lee’s students used the concepts of 1D kinematics – displacement, speed, velocity, and acceleration – to determine if a Jamaican sprinter could beat Dilophosaurus wetherilli in a hypothetical race. Heck, it took me 2 days to be able to pronounce Dilophosaurus wetherilli. Don’t get me started on etymology.

Fair enough, my friend. What else can you tell us?

In his article in The Physics Teacher, Dr. Lee noted that recent musculoskeletal models of vertebrate animals have shown that a dinosaur like Dilophosaurus could run about as fast as Usain Bolt when he set the world record of 9.58 seconds for 100 meters in 2009. You might remember Dilophosaurus from “Jurassic Park.” It was the one that attacked the guy who played Newman on “Seinfeld.”

Fascinating stuff, Peyton, but it looks like the race is about to start. And they’re off! Newton’s second law, which says that acceleration is determined by a combination of mass and force, gives the smaller Bolt an early advantage. The dinosaur takes longer to reach maximum running velocity and crosses the line 2 seconds behind the world’s fastest human. Amazing!

Be sure to tune in again next week, when tennis legend Serena Williams takes the court against a hungry velociraptor.
 

Turning back the egg timer

The idea of getting older can be scary. Wouldn’t it be nice if we could reverse the aging process? Nice, sure, but not possible. Well, it may just be possible for women undergoing assisted reproductive treatment.

Gerd Altmann/Pixabay

It’s generally known that oocytes accumulate DNA damage over time as well, hindering fertility, but a lab in Jerusalem has found a way to reverse the age of eggs.

If you’re wondering how on Earth that was possible, here’s how. Scientists from the Hebrew University of Jerusalem said that they found a previously unknown aging mechanism, which they were able to reverse using antiviral medications, they reported in Aging Cell.

The experiment started on mice eggs, but soon real human eggs were donated. After the procedure, the treated eggs appeared younger, with less of the DNA damage that comes from age. Sperm has not yet been used to test fertility so it is unclear if this will result in something game changing, but the investigators have high hopes.

“Many women are trying to get pregnant aged 40 or over, and we think this could actually increase their level of fertility,” senior investigator Michael Klutstein, PhD, told the Times of Israel. “Within 10 years, we hope to use antiviral drugs to increase fertility among older women.”

We’re counting on you, science! Do your thing!

From environmental tobacco smoke to ultraviolet (UV) radiation, diesel exhaust particulates, lead, and now, chronic infection with Helicobacter pylori (H pylori) —the Report on Carcinogens has regularly updated the list of substances known or “reasonably anticipated” to cause cancer.

The 15th report, which is prepared by the National Toxicology Program (NTP) for the Department of Health and Human Services, has 8 new entries, bringing the number of human carcinogens (eg, metals, pesticides, and drugs) on the list to 256. (The first report, released in 1980, listed 26.) In addition to H. pylori infection, this edition adds the flame-retardant chemical antimony trioxide, and 6 haloacetic acids found as water disinfection byproducts.

In 1971, then-President Nixon declared “war on cancer” (the second leading cause of death in the United States) and signed the National Cancer Act. In 1978, Congress ordered the Report on Carcinogens, to educate the public and health professionals on potential environmental carcinogenic hazards.

Perhaps disheartening to know that even with 256 entries, the list probably understates the number of carcinogens humans and other creatures are exposed to. But things can change with time. Each list goes through a rigorous round of reviews. Sometimes substances are “delisted” after, for instance, litigation or new research. Saccharin, for example, was removed from the ninth edition. It was listed as “reasonably anticipated” in 1981, based on “sufficient evidence of carcinogenicity in experimental animals.” It was removed, however, after extensive review of decades of saccharin use determined that the data were not sufficient to meet current criteria. Further research had revealed, also, that the observed bladder tumors in rats arose from a mechanism not relevant to humans.

Other entries, such as the controversial listing of the cancer drug tamoxifen, walk a fine line between risk and benefit. Tamoxifen, first listed in the ninth report (and still in the 15th report), was included because studies revealed that it could increase the risk of uterine cancer in women. But there also was conclusive evidence that it may prevent or delay breast cancer in women who are at high risk.

Ultimately, the report’s authors make it clear that it is for informative value and guidance, not necessarily a dictate. As one report put it: “Personal decisions concerning voluntary exposures to carcinogenic agents need to be based on additional information that is beyond the scope” of the report.

“As the identification of carcinogens is a key step in cancer prevention,” said Rick Woychik, PhD, director of the National Institute of Environmental Health Sciences and NTP, “publication of the report represents an important government activity towards improving public health.”

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

From environmental tobacco smoke to ultraviolet (UV) radiation, diesel exhaust particulates, lead, and now, chronic infection with Helicobacter pylori (H pylori) —the Report on Carcinogens has regularly updated the list of substances known or “reasonably anticipated” to cause cancer.

The 15th report, which is prepared by the National Toxicology Program (NTP) for the Department of Health and Human Services, has 8 new entries, bringing the number of human carcinogens (eg, metals, pesticides, and drugs) on the list to 256. (The first report, released in 1980, listed 26.) In addition to H. pylori infection, this edition adds the flame-retardant chemical antimony trioxide, and 6 haloacetic acids found as water disinfection byproducts.

In 1971, then-President Nixon declared “war on cancer” (the second leading cause of death in the United States) and signed the National Cancer Act. In 1978, Congress ordered the Report on Carcinogens, to educate the public and health professionals on potential environmental carcinogenic hazards.

Perhaps disheartening to know that even with 256 entries, the list probably understates the number of carcinogens humans and other creatures are exposed to. But things can change with time. Each list goes through a rigorous round of reviews. Sometimes substances are “delisted” after, for instance, litigation or new research. Saccharin, for example, was removed from the ninth edition. It was listed as “reasonably anticipated” in 1981, based on “sufficient evidence of carcinogenicity in experimental animals.” It was removed, however, after extensive review of decades of saccharin use determined that the data were not sufficient to meet current criteria. Further research had revealed, also, that the observed bladder tumors in rats arose from a mechanism not relevant to humans.

Other entries, such as the controversial listing of the cancer drug tamoxifen, walk a fine line between risk and benefit. Tamoxifen, first listed in the ninth report (and still in the 15th report), was included because studies revealed that it could increase the risk of uterine cancer in women. But there also was conclusive evidence that it may prevent or delay breast cancer in women who are at high risk.

Ultimately, the report’s authors make it clear that it is for informative value and guidance, not necessarily a dictate. As one report put it: “Personal decisions concerning voluntary exposures to carcinogenic agents need to be based on additional information that is beyond the scope” of the report.

“As the identification of carcinogens is a key step in cancer prevention,” said Rick Woychik, PhD, director of the National Institute of Environmental Health Sciences and NTP, “publication of the report represents an important government activity towards improving public health.”

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

From environmental tobacco smoke to ultraviolet (UV) radiation, diesel exhaust particulates, lead, and now, chronic infection with Helicobacter pylori (H pylori) —the Report on Carcinogens has regularly updated the list of substances known or “reasonably anticipated” to cause cancer.

The 15th report, which is prepared by the National Toxicology Program (NTP) for the Department of Health and Human Services, has 8 new entries, bringing the number of human carcinogens (eg, metals, pesticides, and drugs) on the list to 256. (The first report, released in 1980, listed 26.) In addition to H. pylori infection, this edition adds the flame-retardant chemical antimony trioxide, and 6 haloacetic acids found as water disinfection byproducts.

In 1971, then-President Nixon declared “war on cancer” (the second leading cause of death in the United States) and signed the National Cancer Act. In 1978, Congress ordered the Report on Carcinogens, to educate the public and health professionals on potential environmental carcinogenic hazards.

Perhaps disheartening to know that even with 256 entries, the list probably understates the number of carcinogens humans and other creatures are exposed to. But things can change with time. Each list goes through a rigorous round of reviews. Sometimes substances are “delisted” after, for instance, litigation or new research. Saccharin, for example, was removed from the ninth edition. It was listed as “reasonably anticipated” in 1981, based on “sufficient evidence of carcinogenicity in experimental animals.” It was removed, however, after extensive review of decades of saccharin use determined that the data were not sufficient to meet current criteria. Further research had revealed, also, that the observed bladder tumors in rats arose from a mechanism not relevant to humans.

Other entries, such as the controversial listing of the cancer drug tamoxifen, walk a fine line between risk and benefit. Tamoxifen, first listed in the ninth report (and still in the 15th report), was included because studies revealed that it could increase the risk of uterine cancer in women. But there also was conclusive evidence that it may prevent or delay breast cancer in women who are at high risk.

Ultimately, the report’s authors make it clear that it is for informative value and guidance, not necessarily a dictate. As one report put it: “Personal decisions concerning voluntary exposures to carcinogenic agents need to be based on additional information that is beyond the scope” of the report.

“As the identification of carcinogens is a key step in cancer prevention,” said Rick Woychik, PhD, director of the National Institute of Environmental Health Sciences and NTP, “publication of the report represents an important government activity towards improving public health.”

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

The federal government’s efforts to thwart information blocking are underway. As such, physicians would do well to be standing at the ready when the information-blocking regulations, designed to ensure that patients can access their electronic health information (EHI), shift into full gear.

Recently, the Office of the National Coordinator revealed that the Department of Health & Humans Services has received 299 reports of information blocking since inviting anyone who suspected that health care providers, IT developers, or health information networks/exchanges might have interfered with access, exchange, or use of EHI through the Report Information Blocking Portal on April 5, 2021.

The vast majority of these claims – 211 – were filed against providers, while 46 alleged incidents of information blocking were by health IT developers, and two claims point to health information networks/ exchanges. The other 25 claims did not appear to present a claim of information blocking.

Of the 274 possible claims of information blocking recently released by ONC, 176 were made by patients.

The ONC has sent all possible claims to the HHS’s Office of the Inspector General. The claims have not yet been investigated and substantiated.
 

Do the stats tell the story?

The numbers in the recent ONC report do not shed much light on how much impact the regulations are having on information sharing. Health care providers, including physicians, might not yet be complying with the rules because monetary penalties are not in place.

Indeed, HHS has yet to spell out exactly what the disincentives on providers will be, though the 21st Century Cures Act stipulates that regulators could fine up to $1 million per information-blocking incident.

“Some providers might be saying, ‘I’m not going to be penalized at this point … so I can take a little bit longer to think about how I come into compliance.’ That could be just one factor of a host of many that are affecting compliance. We also are still in the middle of a public health emergency. So it’s hard to say at this point” exactly how the regulations will affect information blocking, Lauren Riplinger, vice president of policy and public affairs at the American Health Information Management Association, Chicago, said in an interview.
 

A long time coming

The government first zeroed in on ensuring that patients have access to their information in 2016 when President Obama signed the Cures Act into law. The legislation directed ONC to implement a standardized process for the public to report claims of possible information blocking.

The initiative appears to be picking up steam. The ONC is expected to release monthly reports on the cumulative number of information-blocking claims. The announcement of associated penalties is expected sometime in the future.

Industry leaders are advising health care providers to brush up on compliance. Physicians can look to professional groups such as the American Medical Association, the Medical Group Management Association, and other specialty associations for guidance. In addition, the ONC is educating providers on the rule.

“The ONC has provided a lot of great content for the past couple months, not only in terms of putting out FAQs to help clarify some of the gray areas in the rule, but they also have produced a series of provider-specific webinars where they walk through a potential scenario and address the extent to the rules apply,” Ms. Riplinger said.
 

With education, more is better

These efforts, however, could be expanded, according to MGMA.

“There is a general awareness of the rules, but we encourage ONC to continue educating the provider community: More FAQs and educational webinars would be helpful,” Claire Ernst, director of government affairs for MGMA, said in an interview. “A June 2021 MGMA poll found that 51% of medical groups said they needed more government guidance on complying with the new information-blocking rules.”

Although ONC already has provided some “scenario-based” education, more of this type of guidance could prove valuable.

“This rule is that it is very circumstance based. … and so it’s those more nuanced cases that I think are more challenging for providers to know whether or not they are engaging in information blocking,” Ms. Riplinger noted.

For example, a physician might choose to not upload lab test results to a patient portal and prefer to wait to discuss the results directly with the patient, which could potentially be construed as information blocking under the regulations.

The MGMA is requesting that ONC take a second look at these situations – and possibly adjust the regulations.

“MGMA has heard concerns about the impact of providing immediate results to patients before medical groups have the time to thoroughly review test results and discuss them compassionately with their patients,” Ms. Ernst said. “To address this, ONC could expand the current definition of harm to account for other unintended consequences, such as emotional distress, or provide more flexibility in terms of the time frame.”

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

The federal government’s efforts to thwart information blocking are underway. As such, physicians would do well to be standing at the ready when the information-blocking regulations, designed to ensure that patients can access their electronic health information (EHI), shift into full gear.

Recently, the Office of the National Coordinator revealed that the Department of Health & Humans Services has received 299 reports of information blocking since inviting anyone who suspected that health care providers, IT developers, or health information networks/exchanges might have interfered with access, exchange, or use of EHI through the Report Information Blocking Portal on April 5, 2021.

The vast majority of these claims – 211 – were filed against providers, while 46 alleged incidents of information blocking were by health IT developers, and two claims point to health information networks/ exchanges. The other 25 claims did not appear to present a claim of information blocking.

Of the 274 possible claims of information blocking recently released by ONC, 176 were made by patients.

The ONC has sent all possible claims to the HHS’s Office of the Inspector General. The claims have not yet been investigated and substantiated.
 

Do the stats tell the story?

The numbers in the recent ONC report do not shed much light on how much impact the regulations are having on information sharing. Health care providers, including physicians, might not yet be complying with the rules because monetary penalties are not in place.

Indeed, HHS has yet to spell out exactly what the disincentives on providers will be, though the 21st Century Cures Act stipulates that regulators could fine up to $1 million per information-blocking incident.

“Some providers might be saying, ‘I’m not going to be penalized at this point … so I can take a little bit longer to think about how I come into compliance.’ That could be just one factor of a host of many that are affecting compliance. We also are still in the middle of a public health emergency. So it’s hard to say at this point” exactly how the regulations will affect information blocking, Lauren Riplinger, vice president of policy and public affairs at the American Health Information Management Association, Chicago, said in an interview.
 

A long time coming

The government first zeroed in on ensuring that patients have access to their information in 2016 when President Obama signed the Cures Act into law. The legislation directed ONC to implement a standardized process for the public to report claims of possible information blocking.

The initiative appears to be picking up steam. The ONC is expected to release monthly reports on the cumulative number of information-blocking claims. The announcement of associated penalties is expected sometime in the future.

Industry leaders are advising health care providers to brush up on compliance. Physicians can look to professional groups such as the American Medical Association, the Medical Group Management Association, and other specialty associations for guidance. In addition, the ONC is educating providers on the rule.

“The ONC has provided a lot of great content for the past couple months, not only in terms of putting out FAQs to help clarify some of the gray areas in the rule, but they also have produced a series of provider-specific webinars where they walk through a potential scenario and address the extent to the rules apply,” Ms. Riplinger said.
 

With education, more is better

These efforts, however, could be expanded, according to MGMA.

“There is a general awareness of the rules, but we encourage ONC to continue educating the provider community: More FAQs and educational webinars would be helpful,” Claire Ernst, director of government affairs for MGMA, said in an interview. “A June 2021 MGMA poll found that 51% of medical groups said they needed more government guidance on complying with the new information-blocking rules.”

Although ONC already has provided some “scenario-based” education, more of this type of guidance could prove valuable.

“This rule is that it is very circumstance based. … and so it’s those more nuanced cases that I think are more challenging for providers to know whether or not they are engaging in information blocking,” Ms. Riplinger noted.

For example, a physician might choose to not upload lab test results to a patient portal and prefer to wait to discuss the results directly with the patient, which could potentially be construed as information blocking under the regulations.

The MGMA is requesting that ONC take a second look at these situations – and possibly adjust the regulations.

“MGMA has heard concerns about the impact of providing immediate results to patients before medical groups have the time to thoroughly review test results and discuss them compassionately with their patients,” Ms. Ernst said. “To address this, ONC could expand the current definition of harm to account for other unintended consequences, such as emotional distress, or provide more flexibility in terms of the time frame.”

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

The federal government’s efforts to thwart information blocking are underway. As such, physicians would do well to be standing at the ready when the information-blocking regulations, designed to ensure that patients can access their electronic health information (EHI), shift into full gear.

Recently, the Office of the National Coordinator revealed that the Department of Health & Humans Services has received 299 reports of information blocking since inviting anyone who suspected that health care providers, IT developers, or health information networks/exchanges might have interfered with access, exchange, or use of EHI through the Report Information Blocking Portal on April 5, 2021.

The vast majority of these claims – 211 – were filed against providers, while 46 alleged incidents of information blocking were by health IT developers, and two claims point to health information networks/ exchanges. The other 25 claims did not appear to present a claim of information blocking.

Of the 274 possible claims of information blocking recently released by ONC, 176 were made by patients.

The ONC has sent all possible claims to the HHS’s Office of the Inspector General. The claims have not yet been investigated and substantiated.
 

Do the stats tell the story?

The numbers in the recent ONC report do not shed much light on how much impact the regulations are having on information sharing. Health care providers, including physicians, might not yet be complying with the rules because monetary penalties are not in place.

Indeed, HHS has yet to spell out exactly what the disincentives on providers will be, though the 21st Century Cures Act stipulates that regulators could fine up to $1 million per information-blocking incident.

“Some providers might be saying, ‘I’m not going to be penalized at this point … so I can take a little bit longer to think about how I come into compliance.’ That could be just one factor of a host of many that are affecting compliance. We also are still in the middle of a public health emergency. So it’s hard to say at this point” exactly how the regulations will affect information blocking, Lauren Riplinger, vice president of policy and public affairs at the American Health Information Management Association, Chicago, said in an interview.
 

A long time coming

The government first zeroed in on ensuring that patients have access to their information in 2016 when President Obama signed the Cures Act into law. The legislation directed ONC to implement a standardized process for the public to report claims of possible information blocking.

The initiative appears to be picking up steam. The ONC is expected to release monthly reports on the cumulative number of information-blocking claims. The announcement of associated penalties is expected sometime in the future.

Industry leaders are advising health care providers to brush up on compliance. Physicians can look to professional groups such as the American Medical Association, the Medical Group Management Association, and other specialty associations for guidance. In addition, the ONC is educating providers on the rule.

“The ONC has provided a lot of great content for the past couple months, not only in terms of putting out FAQs to help clarify some of the gray areas in the rule, but they also have produced a series of provider-specific webinars where they walk through a potential scenario and address the extent to the rules apply,” Ms. Riplinger said.
 

With education, more is better

These efforts, however, could be expanded, according to MGMA.

“There is a general awareness of the rules, but we encourage ONC to continue educating the provider community: More FAQs and educational webinars would be helpful,” Claire Ernst, director of government affairs for MGMA, said in an interview. “A June 2021 MGMA poll found that 51% of medical groups said they needed more government guidance on complying with the new information-blocking rules.”

Although ONC already has provided some “scenario-based” education, more of this type of guidance could prove valuable.

“This rule is that it is very circumstance based. … and so it’s those more nuanced cases that I think are more challenging for providers to know whether or not they are engaging in information blocking,” Ms. Riplinger noted.

For example, a physician might choose to not upload lab test results to a patient portal and prefer to wait to discuss the results directly with the patient, which could potentially be construed as information blocking under the regulations.

The MGMA is requesting that ONC take a second look at these situations – and possibly adjust the regulations.

“MGMA has heard concerns about the impact of providing immediate results to patients before medical groups have the time to thoroughly review test results and discuss them compassionately with their patients,” Ms. Ernst said. “To address this, ONC could expand the current definition of harm to account for other unintended consequences, such as emotional distress, or provide more flexibility in terms of the time frame.”

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

Six key bacterial species of the gut microbiome have been identified as predictors of the development of type 2 diabetes, according to results from a 15-year follow-up study of more than 5,000 people in Finland.

“We are not aware of previous long-term prospective studies of the associations between type 2 diabetes and the gut microbiome similar to the current study,” stated the authors of the study, published online Jan. 31, 2022, in Diabetes Care.

Though requiring further validation, the results “build on and extend previous mainly cross-sectional evidence and further support links between dietary habits, metabolic diseases, and type 2 diabetes that are modulated by the gut microbiome,” the authors wrote.

The findings are from a prospective study of data on fecal samples from 5,572 people in Finland in 2002 in the FINRISK 2002 population cohort. In 2017, the samples were sent for sequencing as follow-up.

Of note, the study excluded people with prevalent diabetes at baseline, including those being treated with antidiabetic drugs such as metformin.
 

Four species, two clusters associated with type 2 diabetes development

Over a median follow-up of 15.8 years, 432 (7.8%) participants went on to have a diagnosis of type 2 diabetes, and the presence of four species and two clusters at baseline were significantly associated with the development of type 2 diabetes.

The four species include Clostridium citroniae (hazard ratio, 1.21; unadjusted P = .02), C. bolteae (HR, 1.20; unadjusted P = .01), Tyzzerella nexilis (HR, 1.17; unadjusted P = .03), and Ruminococcus gnavus (HR, 1.17; P = .04).

And the two positively associated clusters mostly consisted of the same species (both HR, 1.18).

Importantly, the associations were nearly the same among participants in eastern and western Finland, which are known for having unique genetic as well as lifestyle differences that impact morbidity and mortality.

“Three of these taxa could be clustered together by proportional abundance in both geographic areas, and combined abundance of the four taxa was also predictive of incident type 2 diabetes,” the authors wrote.

They noted that the identified species have been previously associated with type 2 diabetes and appear to be linked in some ways to the quality of diet and with other metabolic diseases, such as fatty liver disease.

C. citroniae, for instance, has been associated with trimethylamine N-oxide (TMAO), a compound likely linked to the intake of red meat, and the authors noted that a direct association between red meat intake and type 2 diabetes risk has been known for more than 15 years.

TMAO has also been associated with adipose tissue inflammation and impeded hepatic insulin signaling, which are all involved in increased insulin resistance, high blood glucose levels, and type 2 diabetes, the authors explained.

R. gnavus has been previously associated with obesity in humans and animals. And the bacterial species is also “potentially related to glucose metabolism regulation and linked to increases in inflammatory cytokines, both of which are related to type 2 diabetes pathophysiology,” the authors reported.
 

Stepping stone toward improved prediction

Coauthor Teemu J. Niiranen, MD, PhD, of the division of medicine, Turku (Finland) University Hospital, noted that, while prior studies have linked type 2 diabetes with distinctive characteristics of gut microbiome composition, most studies have not included prospective data, and long-term studies have been lacking.

Furthermore, many of the studies could have been confounded by the use of antidiabetic drugs that could influence gut microbiome composition, including metformin, which was excluded in the current study.

“We avoid several of the biases related to cross-sectional studies, such as the confounding effects of diabetes medications,” Dr. Niiranen said in an interview.

“We also know the temporal sequence of the exposure and the outcome, and that the changes in the gut microbiome preceded the development of diabetes,” he said. “All in all, a cohort study like this provides a much greater level of evidence than cross-sectional studies.”

Dr. Niiranen noted, however, that “although we demonstrate that certain gut microbiome changes are associated with greater risk of future diabetes, we are still quite far from clinical use.”

In addition to needing to replicate the results in other ethnic groups and locations, “we would need to find optimal clinical cutoffs for clinical decision-making and demonstrate the amount increase in predictive ability, compared with conventional diabetes risk factors,” he said.

The study nevertheless “serves as a stepping stone toward the goal of improved prediction and the development of effective treatments for type 2 diabetes through modification of the gut microbiome,” the authors wrote.

Other research has shed light on gut bacteria that appear to be linked to the prevention rather than the development of diabetes, identifying species that help produce butyrate, a short-chain fatty acid that may in fact provide protection against type 2 diabetes.

And additional research does suggest potential clinical implications. Efforts to improve insulin sensitivity via the gut through fecal microbial transplantation are also making headway, with an oral capsule formulation showing benefit among patients with severe obesity.

The research was funded in part by grants from the Finnish Cultural Foundation, the Finnish Foundation for Cardiovascular Research, the Emil Aaltonen Foundation, the Finnish Medical Foundation, the Sigrid Jusélius Foundation, and the Academy of Finland.

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

Six key bacterial species of the gut microbiome have been identified as predictors of the development of type 2 diabetes, according to results from a 15-year follow-up study of more than 5,000 people in Finland.

“We are not aware of previous long-term prospective studies of the associations between type 2 diabetes and the gut microbiome similar to the current study,” stated the authors of the study, published online Jan. 31, 2022, in Diabetes Care.

Though requiring further validation, the results “build on and extend previous mainly cross-sectional evidence and further support links between dietary habits, metabolic diseases, and type 2 diabetes that are modulated by the gut microbiome,” the authors wrote.

The findings are from a prospective study of data on fecal samples from 5,572 people in Finland in 2002 in the FINRISK 2002 population cohort. In 2017, the samples were sent for sequencing as follow-up.

Of note, the study excluded people with prevalent diabetes at baseline, including those being treated with antidiabetic drugs such as metformin.
 

Four species, two clusters associated with type 2 diabetes development

Over a median follow-up of 15.8 years, 432 (7.8%) participants went on to have a diagnosis of type 2 diabetes, and the presence of four species and two clusters at baseline were significantly associated with the development of type 2 diabetes.

The four species include Clostridium citroniae (hazard ratio, 1.21; unadjusted P = .02), C. bolteae (HR, 1.20; unadjusted P = .01), Tyzzerella nexilis (HR, 1.17; unadjusted P = .03), and Ruminococcus gnavus (HR, 1.17; P = .04).

And the two positively associated clusters mostly consisted of the same species (both HR, 1.18).

Importantly, the associations were nearly the same among participants in eastern and western Finland, which are known for having unique genetic as well as lifestyle differences that impact morbidity and mortality.

“Three of these taxa could be clustered together by proportional abundance in both geographic areas, and combined abundance of the four taxa was also predictive of incident type 2 diabetes,” the authors wrote.

They noted that the identified species have been previously associated with type 2 diabetes and appear to be linked in some ways to the quality of diet and with other metabolic diseases, such as fatty liver disease.

C. citroniae, for instance, has been associated with trimethylamine N-oxide (TMAO), a compound likely linked to the intake of red meat, and the authors noted that a direct association between red meat intake and type 2 diabetes risk has been known for more than 15 years.

TMAO has also been associated with adipose tissue inflammation and impeded hepatic insulin signaling, which are all involved in increased insulin resistance, high blood glucose levels, and type 2 diabetes, the authors explained.

R. gnavus has been previously associated with obesity in humans and animals. And the bacterial species is also “potentially related to glucose metabolism regulation and linked to increases in inflammatory cytokines, both of which are related to type 2 diabetes pathophysiology,” the authors reported.
 

Stepping stone toward improved prediction

Coauthor Teemu J. Niiranen, MD, PhD, of the division of medicine, Turku (Finland) University Hospital, noted that, while prior studies have linked type 2 diabetes with distinctive characteristics of gut microbiome composition, most studies have not included prospective data, and long-term studies have been lacking.

Furthermore, many of the studies could have been confounded by the use of antidiabetic drugs that could influence gut microbiome composition, including metformin, which was excluded in the current study.

“We avoid several of the biases related to cross-sectional studies, such as the confounding effects of diabetes medications,” Dr. Niiranen said in an interview.

“We also know the temporal sequence of the exposure and the outcome, and that the changes in the gut microbiome preceded the development of diabetes,” he said. “All in all, a cohort study like this provides a much greater level of evidence than cross-sectional studies.”

Dr. Niiranen noted, however, that “although we demonstrate that certain gut microbiome changes are associated with greater risk of future diabetes, we are still quite far from clinical use.”

In addition to needing to replicate the results in other ethnic groups and locations, “we would need to find optimal clinical cutoffs for clinical decision-making and demonstrate the amount increase in predictive ability, compared with conventional diabetes risk factors,” he said.

The study nevertheless “serves as a stepping stone toward the goal of improved prediction and the development of effective treatments for type 2 diabetes through modification of the gut microbiome,” the authors wrote.

Other research has shed light on gut bacteria that appear to be linked to the prevention rather than the development of diabetes, identifying species that help produce butyrate, a short-chain fatty acid that may in fact provide protection against type 2 diabetes.

And additional research does suggest potential clinical implications. Efforts to improve insulin sensitivity via the gut through fecal microbial transplantation are also making headway, with an oral capsule formulation showing benefit among patients with severe obesity.

The research was funded in part by grants from the Finnish Cultural Foundation, the Finnish Foundation for Cardiovascular Research, the Emil Aaltonen Foundation, the Finnish Medical Foundation, the Sigrid Jusélius Foundation, and the Academy of Finland.

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

Six key bacterial species of the gut microbiome have been identified as predictors of the development of type 2 diabetes, according to results from a 15-year follow-up study of more than 5,000 people in Finland.

“We are not aware of previous long-term prospective studies of the associations between type 2 diabetes and the gut microbiome similar to the current study,” stated the authors of the study, published online Jan. 31, 2022, in Diabetes Care.

Though requiring further validation, the results “build on and extend previous mainly cross-sectional evidence and further support links between dietary habits, metabolic diseases, and type 2 diabetes that are modulated by the gut microbiome,” the authors wrote.

The findings are from a prospective study of data on fecal samples from 5,572 people in Finland in 2002 in the FINRISK 2002 population cohort. In 2017, the samples were sent for sequencing as follow-up.

Of note, the study excluded people with prevalent diabetes at baseline, including those being treated with antidiabetic drugs such as metformin.
 

Four species, two clusters associated with type 2 diabetes development

Over a median follow-up of 15.8 years, 432 (7.8%) participants went on to have a diagnosis of type 2 diabetes, and the presence of four species and two clusters at baseline were significantly associated with the development of type 2 diabetes.

The four species include Clostridium citroniae (hazard ratio, 1.21; unadjusted P = .02), C. bolteae (HR, 1.20; unadjusted P = .01), Tyzzerella nexilis (HR, 1.17; unadjusted P = .03), and Ruminococcus gnavus (HR, 1.17; P = .04).

And the two positively associated clusters mostly consisted of the same species (both HR, 1.18).

Importantly, the associations were nearly the same among participants in eastern and western Finland, which are known for having unique genetic as well as lifestyle differences that impact morbidity and mortality.

“Three of these taxa could be clustered together by proportional abundance in both geographic areas, and combined abundance of the four taxa was also predictive of incident type 2 diabetes,” the authors wrote.

They noted that the identified species have been previously associated with type 2 diabetes and appear to be linked in some ways to the quality of diet and with other metabolic diseases, such as fatty liver disease.

C. citroniae, for instance, has been associated with trimethylamine N-oxide (TMAO), a compound likely linked to the intake of red meat, and the authors noted that a direct association between red meat intake and type 2 diabetes risk has been known for more than 15 years.

TMAO has also been associated with adipose tissue inflammation and impeded hepatic insulin signaling, which are all involved in increased insulin resistance, high blood glucose levels, and type 2 diabetes, the authors explained.

R. gnavus has been previously associated with obesity in humans and animals. And the bacterial species is also “potentially related to glucose metabolism regulation and linked to increases in inflammatory cytokines, both of which are related to type 2 diabetes pathophysiology,” the authors reported.
 

Stepping stone toward improved prediction

Coauthor Teemu J. Niiranen, MD, PhD, of the division of medicine, Turku (Finland) University Hospital, noted that, while prior studies have linked type 2 diabetes with distinctive characteristics of gut microbiome composition, most studies have not included prospective data, and long-term studies have been lacking.

Furthermore, many of the studies could have been confounded by the use of antidiabetic drugs that could influence gut microbiome composition, including metformin, which was excluded in the current study.

“We avoid several of the biases related to cross-sectional studies, such as the confounding effects of diabetes medications,” Dr. Niiranen said in an interview.

“We also know the temporal sequence of the exposure and the outcome, and that the changes in the gut microbiome preceded the development of diabetes,” he said. “All in all, a cohort study like this provides a much greater level of evidence than cross-sectional studies.”

Dr. Niiranen noted, however, that “although we demonstrate that certain gut microbiome changes are associated with greater risk of future diabetes, we are still quite far from clinical use.”

In addition to needing to replicate the results in other ethnic groups and locations, “we would need to find optimal clinical cutoffs for clinical decision-making and demonstrate the amount increase in predictive ability, compared with conventional diabetes risk factors,” he said.

The study nevertheless “serves as a stepping stone toward the goal of improved prediction and the development of effective treatments for type 2 diabetes through modification of the gut microbiome,” the authors wrote.

Other research has shed light on gut bacteria that appear to be linked to the prevention rather than the development of diabetes, identifying species that help produce butyrate, a short-chain fatty acid that may in fact provide protection against type 2 diabetes.

And additional research does suggest potential clinical implications. Efforts to improve insulin sensitivity via the gut through fecal microbial transplantation are also making headway, with an oral capsule formulation showing benefit among patients with severe obesity.

The research was funded in part by grants from the Finnish Cultural Foundation, the Finnish Foundation for Cardiovascular Research, the Emil Aaltonen Foundation, the Finnish Medical Foundation, the Sigrid Jusélius Foundation, and the Academy of Finland.

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

Data from the first 6 months after the rollout of mRNA COVID-19 vaccines in the United States released today show that adverse effects from shots are typically mild and short-lived.

Findings of the large study, compiled after nearly 300 million doses were administered, were published online March 7 in The Lancet Infectious Diseases.

Researchers, led by Hannah G. Rosenblum, MD, with the Centers for Disease Control and Prevention COVID Response Team, used passive U.S. surveillance data collected through the Vaccine Adverse Event Reporting System (VAERS), and the active system, v-safe, starting in December 2020 through the first 6 months of the U.S. COVID-19 vaccination program. V-safe is a voluntary, smartphone-based system set up in 2020 specifically for monitoring reactions to COVID-19 and health effects after vaccination. The health effects information from v-safe is presented in this study for the first time.

Of the 298.7 million doses of mRNA vaccines administered in the U.S. during the study period, VAERS processed 340,522 reports. Of those, 313,499 (92.1%) were nonserious; 22,527 (6.6%) were serious (nondeath); and 4,496 (1.3%) were deaths.

From v-safe reporting, researchers learned that about 71% of the 7.9 million participants reported local or systemic reactions, more frequently after dose 2 than after dose 1. Of those reporting reactions after dose 1, about two-thirds (68.6%) reported a local reaction and 52.7% reported a systemic reaction.

Among other findings:

• Injection-site pain occurred after dose 1 in 66.2% of participants and 68.6% after dose 2.
• One-third of participants (33.9%) reported fatigue after dose 1 and 55.7% after dose 2.
• Headache was reported among 27% of participants after dose 1 and 46.2% after dose 2.
• When injection site pain, fatigue, or headaches were reported, the reports were usually in the first week after vaccination.
• Reports of being unable to work or do normal daily activities, or instances of seeking medical care, occurred more commonly after dose 2 (32.1%) than after dose 1 (11.9%). Fewer than 1% of participants reported seeking medical care after dose 1 or 2 of the vaccine.
• Reactions and health effects were reported more often in female than in male recipients, and in people younger than 65 years, compared with older people.
• Serious adverse events, including myocarditis, have been identified following mRNA vaccinations, but the events are rare.

The authors wrote that these results are consistent with preauthorization clinical trials and early postauthorization reports.

“On the basis of our findings, mild to moderate transient reactogenicity should be anticipated,” they said, “particularly among younger and female vaccine recipients.”
 

‘Robust and reassuring data’

“The safety monitoring of the mRNA COVID-19 vaccines stands out as the most comprehensive of any vaccine in U.S. history. The use of these complementary monitoring systems has provided robust and reassuring data,” Matthew S. Krantz, MD, with the division of allergy, pulmonary, and critical care medicine at Vanderbilt University, Nashville, Tenn., and Elizabeth J. Phillips, MD, with the department of pathology, microbiology, and immunology at Vanderbilt, wrote in a related commentary in The Lancet Infectious Diseases.

They point out that the v-safe reports of reactions are consistent with those reported from clinical trials and a large population study in the United Kingdom.

Dr. Phillips said in a press release, “[A]lthough approximately one in 1,000 individuals vaccinated may have an adverse effect, most of these are nonserious. No unusual patterns emerged in the cause of death or serious adverse effects among VAERS reports. For adverse events of special interest, it is reassuring that there were no unexpected signals other than myopericarditis and anaphylaxis, already known to be associated with mRNA vaccines.”

The study authors and editorialists have disclosed no relevant financial relationships.

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

Data from the first 6 months after the rollout of mRNA COVID-19 vaccines in the United States released today show that adverse effects from shots are typically mild and short-lived.

Findings of the large study, compiled after nearly 300 million doses were administered, were published online March 7 in The Lancet Infectious Diseases.

Researchers, led by Hannah G. Rosenblum, MD, with the Centers for Disease Control and Prevention COVID Response Team, used passive U.S. surveillance data collected through the Vaccine Adverse Event Reporting System (VAERS), and the active system, v-safe, starting in December 2020 through the first 6 months of the U.S. COVID-19 vaccination program. V-safe is a voluntary, smartphone-based system set up in 2020 specifically for monitoring reactions to COVID-19 and health effects after vaccination. The health effects information from v-safe is presented in this study for the first time.

Of the 298.7 million doses of mRNA vaccines administered in the U.S. during the study period, VAERS processed 340,522 reports. Of those, 313,499 (92.1%) were nonserious; 22,527 (6.6%) were serious (nondeath); and 4,496 (1.3%) were deaths.

From v-safe reporting, researchers learned that about 71% of the 7.9 million participants reported local or systemic reactions, more frequently after dose 2 than after dose 1. Of those reporting reactions after dose 1, about two-thirds (68.6%) reported a local reaction and 52.7% reported a systemic reaction.

Among other findings:

• Injection-site pain occurred after dose 1 in 66.2% of participants and 68.6% after dose 2.
• One-third of participants (33.9%) reported fatigue after dose 1 and 55.7% after dose 2.
• Headache was reported among 27% of participants after dose 1 and 46.2% after dose 2.
• When injection site pain, fatigue, or headaches were reported, the reports were usually in the first week after vaccination.
• Reports of being unable to work or do normal daily activities, or instances of seeking medical care, occurred more commonly after dose 2 (32.1%) than after dose 1 (11.9%). Fewer than 1% of participants reported seeking medical care after dose 1 or 2 of the vaccine.
• Reactions and health effects were reported more often in female than in male recipients, and in people younger than 65 years, compared with older people.
• Serious adverse events, including myocarditis, have been identified following mRNA vaccinations, but the events are rare.

The authors wrote that these results are consistent with preauthorization clinical trials and early postauthorization reports.

“On the basis of our findings, mild to moderate transient reactogenicity should be anticipated,” they said, “particularly among younger and female vaccine recipients.”
 

‘Robust and reassuring data’

“The safety monitoring of the mRNA COVID-19 vaccines stands out as the most comprehensive of any vaccine in U.S. history. The use of these complementary monitoring systems has provided robust and reassuring data,” Matthew S. Krantz, MD, with the division of allergy, pulmonary, and critical care medicine at Vanderbilt University, Nashville, Tenn., and Elizabeth J. Phillips, MD, with the department of pathology, microbiology, and immunology at Vanderbilt, wrote in a related commentary in The Lancet Infectious Diseases.

They point out that the v-safe reports of reactions are consistent with those reported from clinical trials and a large population study in the United Kingdom.

Dr. Phillips said in a press release, “[A]lthough approximately one in 1,000 individuals vaccinated may have an adverse effect, most of these are nonserious. No unusual patterns emerged in the cause of death or serious adverse effects among VAERS reports. For adverse events of special interest, it is reassuring that there were no unexpected signals other than myopericarditis and anaphylaxis, already known to be associated with mRNA vaccines.”

The study authors and editorialists have disclosed no relevant financial relationships.

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

Data from the first 6 months after the rollout of mRNA COVID-19 vaccines in the United States released today show that adverse effects from shots are typically mild and short-lived.

Findings of the large study, compiled after nearly 300 million doses were administered, were published online March 7 in The Lancet Infectious Diseases.

Researchers, led by Hannah G. Rosenblum, MD, with the Centers for Disease Control and Prevention COVID Response Team, used passive U.S. surveillance data collected through the Vaccine Adverse Event Reporting System (VAERS), and the active system, v-safe, starting in December 2020 through the first 6 months of the U.S. COVID-19 vaccination program. V-safe is a voluntary, smartphone-based system set up in 2020 specifically for monitoring reactions to COVID-19 and health effects after vaccination. The health effects information from v-safe is presented in this study for the first time.

Of the 298.7 million doses of mRNA vaccines administered in the U.S. during the study period, VAERS processed 340,522 reports. Of those, 313,499 (92.1%) were nonserious; 22,527 (6.6%) were serious (nondeath); and 4,496 (1.3%) were deaths.

From v-safe reporting, researchers learned that about 71% of the 7.9 million participants reported local or systemic reactions, more frequently after dose 2 than after dose 1. Of those reporting reactions after dose 1, about two-thirds (68.6%) reported a local reaction and 52.7% reported a systemic reaction.

Among other findings:

• Injection-site pain occurred after dose 1 in 66.2% of participants and 68.6% after dose 2.
• One-third of participants (33.9%) reported fatigue after dose 1 and 55.7% after dose 2.
• Headache was reported among 27% of participants after dose 1 and 46.2% after dose 2.
• When injection site pain, fatigue, or headaches were reported, the reports were usually in the first week after vaccination.
• Reports of being unable to work or do normal daily activities, or instances of seeking medical care, occurred more commonly after dose 2 (32.1%) than after dose 1 (11.9%). Fewer than 1% of participants reported seeking medical care after dose 1 or 2 of the vaccine.
• Reactions and health effects were reported more often in female than in male recipients, and in people younger than 65 years, compared with older people.
• Serious adverse events, including myocarditis, have been identified following mRNA vaccinations, but the events are rare.

The authors wrote that these results are consistent with preauthorization clinical trials and early postauthorization reports.

“On the basis of our findings, mild to moderate transient reactogenicity should be anticipated,” they said, “particularly among younger and female vaccine recipients.”
 

‘Robust and reassuring data’

“The safety monitoring of the mRNA COVID-19 vaccines stands out as the most comprehensive of any vaccine in U.S. history. The use of these complementary monitoring systems has provided robust and reassuring data,” Matthew S. Krantz, MD, with the division of allergy, pulmonary, and critical care medicine at Vanderbilt University, Nashville, Tenn., and Elizabeth J. Phillips, MD, with the department of pathology, microbiology, and immunology at Vanderbilt, wrote in a related commentary in The Lancet Infectious Diseases.

They point out that the v-safe reports of reactions are consistent with those reported from clinical trials and a large population study in the United Kingdom.

Dr. Phillips said in a press release, “[A]lthough approximately one in 1,000 individuals vaccinated may have an adverse effect, most of these are nonserious. No unusual patterns emerged in the cause of death or serious adverse effects among VAERS reports. For adverse events of special interest, it is reassuring that there were no unexpected signals other than myopericarditis and anaphylaxis, already known to be associated with mRNA vaccines.”

The study authors and editorialists have disclosed no relevant financial relationships.

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

Female-pattern hair loss (FPHL) was identified in 52% of postmenopausal women, and 4% of these cases involved extensive baldness, based on data from 178 individuals.

FPHL can develop at any time from teenage years through and beyond menopause, wrote Sukanya Chaikittisilpa, MD, of Chulalongkorn University, Bangkok, and colleagues.

The cause of FPHL remains uncertain, but the presence of estrogen receptors in hair follicles suggests that the hormone changes of menopause may affect hair growth, the researchers said.

In a study published in Menopause, the researchers evaluated 178 postmenopausal women aged 50-65 years for FPHL. FPLH was determined based on photographs and on measures of hormone levels, hair density, and hair diameter.

The overall prevalence of FPHL was 52.2%. The hair loss was divided into three categories indicating mild, moderate, and severe (Ludwig grades I, II, and III) with prevalence of 73.2%, 22.6%, and 4.3%, respectively. The prevalence of FPHL also increased with age and time since menopause. In a simple logistic regression analysis, age 56 years and older and more than 6 years since menopause were significantly associated with FPHL (odds ratios, 3.41 and 1.98, respectively).

However, after adjustment for multiple variables, only a body mass index of 25 kg/m² or higher also was associated with increased prevalence of FPHL (adjusted OR, 2.65).

A total of 60% of the study participants met criteria for low self-esteem, including all the women in the severe hair loss category.

“The postmenopausal women with FPHL in our cohort had lower total hair density, terminal hair density, hair thickness, hair unit density, and average hair per unit than those with normal hair patterns,” although vellus hair density was higher in women with FPHL, the researchers wrote in their discussion of the findings. This distinction may be caused in part by the shortened hair cycle and reduced anagen phase of velluslike follicles, they said.

The study findings were limited by several factors, including the cross-sectional design and the inclusion of only women from a single menopause clinic, which may not reflect FPHL in the general population, as well as the reliance on patients’ recall, the researchers noted. Another limitation was the inability to assess postmenopausal hormone levels, they added.

However, “This study may be the first FPHL study conducted in a menopause clinic that targeted only healthy postmenopausal women,” they wrote. More research is needed to determine the potential role of estrogen and testosterone on FPHL in postmenopausal women, and whether a history of polycystic ovarian syndrome has an effect, they said. Meanwhile, current study results may help clinicians and patients determine the most appropriate menopausal hormone therapies for postmenopausal women with FPHL, they concluded.
 

Consider lifestyle and self-esteem issues

The current study is important at this time because a larger proportion of women are either reaching menopause or are menopausal, said Constance Bohon, MD, a gynecologist in private practice in Washington, in an interview.

“Whatever we in the medical community can do to help women transition into the menopausal years with the least anxiety is important,” including helping women feel comfortable about their appearance, she said.

“For women in the peri- and postmenopausal years, hair loss is a relatively common concern,” Dr. Bohon said. However, in the current study, “I was surprised that it was associated with low self-esteem and obesity,” she noted. “For these women, it would be interesting to know whether they also had concerns about the appearance of their bodies, or just their hair loss,” she said. The question is whether the hair loss in and of itself caused low self-esteem in the study population, or whether it exacerbated their already poor self-assessment, Dr. Bohon said. “Another consideration is that perhaps these women were already feeling the effects of aging and were trying to change their appearance by using hair dyes, and now they find themselves losing hair as well,” she noted.

The takeaway message for clinicians is that discussions with perimenopausal and postmenopausal women should include the topic of hair loss along with hot flashes and night sweats, said Dr. Bohon.

Women who are experiencing hair loss or concerned about the possibility of hair loss should ask their doctors about possible interventions that may mitigate or prevent further hair loss, she said.

As for additional research, “the most important issue is to determine the factors that are associated with hair loss in the perimenopausal and postmenopausal years,” Dr. Bohon said. Research questions should include impact of dyeing or straightening hair on the likelihood of hair loss, and whether women with more severe hot flashes/night sweats and/or sleeplessness have more hair loss than women who do not experience any of the symptoms as they go through menopause, she emphasized.

Other considerations are whether certain diets or foods are more common among women who have more hair loss, and whether weight loss into a normal range or weight gain into a body mass index greater than 25 kg/m² affects hair loss, said Dr. Bohon. Also, don’t discount the impact of stress, and whether women who have lost hair identify certain stressful times that preceded their hair loss, as well as what medications could be associated with hair loss, and whether hormone therapy might prevent hair loss, she said.

The study was supported by the Ratchadapiseksompotch Fund, Faculty of Medicine, Chulalongkorn University. The researchers had no financial conflicts to disclose. Dr. Bohon had no financial conflicts to disclose and serves on the Editorial Advisory Board of Ob.Gyn. News.

Female-pattern hair loss (FPHL) was identified in 52% of postmenopausal women, and 4% of these cases involved extensive baldness, based on data from 178 individuals.

FPHL can develop at any time from teenage years through and beyond menopause, wrote Sukanya Chaikittisilpa, MD, of Chulalongkorn University, Bangkok, and colleagues.

The cause of FPHL remains uncertain, but the presence of estrogen receptors in hair follicles suggests that the hormone changes of menopause may affect hair growth, the researchers said.

In a study published in Menopause, the researchers evaluated 178 postmenopausal women aged 50-65 years for FPHL. FPLH was determined based on photographs and on measures of hormone levels, hair density, and hair diameter.

The overall prevalence of FPHL was 52.2%. The hair loss was divided into three categories indicating mild, moderate, and severe (Ludwig grades I, II, and III) with prevalence of 73.2%, 22.6%, and 4.3%, respectively. The prevalence of FPHL also increased with age and time since menopause. In a simple logistic regression analysis, age 56 years and older and more than 6 years since menopause were significantly associated with FPHL (odds ratios, 3.41 and 1.98, respectively).

However, after adjustment for multiple variables, only a body mass index of 25 kg/m² or higher also was associated with increased prevalence of FPHL (adjusted OR, 2.65).

A total of 60% of the study participants met criteria for low self-esteem, including all the women in the severe hair loss category.

“The postmenopausal women with FPHL in our cohort had lower total hair density, terminal hair density, hair thickness, hair unit density, and average hair per unit than those with normal hair patterns,” although vellus hair density was higher in women with FPHL, the researchers wrote in their discussion of the findings. This distinction may be caused in part by the shortened hair cycle and reduced anagen phase of velluslike follicles, they said.

The study findings were limited by several factors, including the cross-sectional design and the inclusion of only women from a single menopause clinic, which may not reflect FPHL in the general population, as well as the reliance on patients’ recall, the researchers noted. Another limitation was the inability to assess postmenopausal hormone levels, they added.

However, “This study may be the first FPHL study conducted in a menopause clinic that targeted only healthy postmenopausal women,” they wrote. More research is needed to determine the potential role of estrogen and testosterone on FPHL in postmenopausal women, and whether a history of polycystic ovarian syndrome has an effect, they said. Meanwhile, current study results may help clinicians and patients determine the most appropriate menopausal hormone therapies for postmenopausal women with FPHL, they concluded.
 

Consider lifestyle and self-esteem issues

The current study is important at this time because a larger proportion of women are either reaching menopause or are menopausal, said Constance Bohon, MD, a gynecologist in private practice in Washington, in an interview.

“Whatever we in the medical community can do to help women transition into the menopausal years with the least anxiety is important,” including helping women feel comfortable about their appearance, she said.

“For women in the peri- and postmenopausal years, hair loss is a relatively common concern,” Dr. Bohon said. However, in the current study, “I was surprised that it was associated with low self-esteem and obesity,” she noted. “For these women, it would be interesting to know whether they also had concerns about the appearance of their bodies, or just their hair loss,” she said. The question is whether the hair loss in and of itself caused low self-esteem in the study population, or whether it exacerbated their already poor self-assessment, Dr. Bohon said. “Another consideration is that perhaps these women were already feeling the effects of aging and were trying to change their appearance by using hair dyes, and now they find themselves losing hair as well,” she noted.

The takeaway message for clinicians is that discussions with perimenopausal and postmenopausal women should include the topic of hair loss along with hot flashes and night sweats, said Dr. Bohon.

Women who are experiencing hair loss or concerned about the possibility of hair loss should ask their doctors about possible interventions that may mitigate or prevent further hair loss, she said.

As for additional research, “the most important issue is to determine the factors that are associated with hair loss in the perimenopausal and postmenopausal years,” Dr. Bohon said. Research questions should include impact of dyeing or straightening hair on the likelihood of hair loss, and whether women with more severe hot flashes/night sweats and/or sleeplessness have more hair loss than women who do not experience any of the symptoms as they go through menopause, she emphasized.

Other considerations are whether certain diets or foods are more common among women who have more hair loss, and whether weight loss into a normal range or weight gain into a body mass index greater than 25 kg/m² affects hair loss, said Dr. Bohon. Also, don’t discount the impact of stress, and whether women who have lost hair identify certain stressful times that preceded their hair loss, as well as what medications could be associated with hair loss, and whether hormone therapy might prevent hair loss, she said.

The study was supported by the Ratchadapiseksompotch Fund, Faculty of Medicine, Chulalongkorn University. The researchers had no financial conflicts to disclose. Dr. Bohon had no financial conflicts to disclose and serves on the Editorial Advisory Board of Ob.Gyn. News.

Female-pattern hair loss (FPHL) was identified in 52% of postmenopausal women, and 4% of these cases involved extensive baldness, based on data from 178 individuals.

FPHL can develop at any time from teenage years through and beyond menopause, wrote Sukanya Chaikittisilpa, MD, of Chulalongkorn University, Bangkok, and colleagues.

The cause of FPHL remains uncertain, but the presence of estrogen receptors in hair follicles suggests that the hormone changes of menopause may affect hair growth, the researchers said.

In a study published in Menopause, the researchers evaluated 178 postmenopausal women aged 50-65 years for FPHL. FPLH was determined based on photographs and on measures of hormone levels, hair density, and hair diameter.

The overall prevalence of FPHL was 52.2%. The hair loss was divided into three categories indicating mild, moderate, and severe (Ludwig grades I, II, and III) with prevalence of 73.2%, 22.6%, and 4.3%, respectively. The prevalence of FPHL also increased with age and time since menopause. In a simple logistic regression analysis, age 56 years and older and more than 6 years since menopause were significantly associated with FPHL (odds ratios, 3.41 and 1.98, respectively).

However, after adjustment for multiple variables, only a body mass index of 25 kg/m² or higher also was associated with increased prevalence of FPHL (adjusted OR, 2.65).

A total of 60% of the study participants met criteria for low self-esteem, including all the women in the severe hair loss category.

“The postmenopausal women with FPHL in our cohort had lower total hair density, terminal hair density, hair thickness, hair unit density, and average hair per unit than those with normal hair patterns,” although vellus hair density was higher in women with FPHL, the researchers wrote in their discussion of the findings. This distinction may be caused in part by the shortened hair cycle and reduced anagen phase of velluslike follicles, they said.

The study findings were limited by several factors, including the cross-sectional design and the inclusion of only women from a single menopause clinic, which may not reflect FPHL in the general population, as well as the reliance on patients’ recall, the researchers noted. Another limitation was the inability to assess postmenopausal hormone levels, they added.

However, “This study may be the first FPHL study conducted in a menopause clinic that targeted only healthy postmenopausal women,” they wrote. More research is needed to determine the potential role of estrogen and testosterone on FPHL in postmenopausal women, and whether a history of polycystic ovarian syndrome has an effect, they said. Meanwhile, current study results may help clinicians and patients determine the most appropriate menopausal hormone therapies for postmenopausal women with FPHL, they concluded.
 

Consider lifestyle and self-esteem issues

The current study is important at this time because a larger proportion of women are either reaching menopause or are menopausal, said Constance Bohon, MD, a gynecologist in private practice in Washington, in an interview.

“Whatever we in the medical community can do to help women transition into the menopausal years with the least anxiety is important,” including helping women feel comfortable about their appearance, she said.

“For women in the peri- and postmenopausal years, hair loss is a relatively common concern,” Dr. Bohon said. However, in the current study, “I was surprised that it was associated with low self-esteem and obesity,” she noted. “For these women, it would be interesting to know whether they also had concerns about the appearance of their bodies, or just their hair loss,” she said. The question is whether the hair loss in and of itself caused low self-esteem in the study population, or whether it exacerbated their already poor self-assessment, Dr. Bohon said. “Another consideration is that perhaps these women were already feeling the effects of aging and were trying to change their appearance by using hair dyes, and now they find themselves losing hair as well,” she noted.

The takeaway message for clinicians is that discussions with perimenopausal and postmenopausal women should include the topic of hair loss along with hot flashes and night sweats, said Dr. Bohon.

Women who are experiencing hair loss or concerned about the possibility of hair loss should ask their doctors about possible interventions that may mitigate or prevent further hair loss, she said.

As for additional research, “the most important issue is to determine the factors that are associated with hair loss in the perimenopausal and postmenopausal years,” Dr. Bohon said. Research questions should include impact of dyeing or straightening hair on the likelihood of hair loss, and whether women with more severe hot flashes/night sweats and/or sleeplessness have more hair loss than women who do not experience any of the symptoms as they go through menopause, she emphasized.

Other considerations are whether certain diets or foods are more common among women who have more hair loss, and whether weight loss into a normal range or weight gain into a body mass index greater than 25 kg/m² affects hair loss, said Dr. Bohon. Also, don’t discount the impact of stress, and whether women who have lost hair identify certain stressful times that preceded their hair loss, as well as what medications could be associated with hair loss, and whether hormone therapy might prevent hair loss, she said.

The study was supported by the Ratchadapiseksompotch Fund, Faculty of Medicine, Chulalongkorn University. The researchers had no financial conflicts to disclose. Dr. Bohon had no financial conflicts to disclose and serves on the Editorial Advisory Board of Ob.Gyn. News.

California-based emergency physician Simone Melissa Gold, MD, JD, founder of the antivaccine group America’s Frontline Doctors (AFD) and leading voice in the antivaccine movement, has pleaded guilty to one of five charges related to the Jan. 6 Capitol riot.

According to the plea deal, Dr. Gold pleaded guilty to charges that she “did unlawfully and knowingly enter and remain in a restricted building and grounds, that is, any posted, cordoned-off, or otherwise restricted area within the United States Capitol and its grounds, during a time when the vice president was in the building without lawful authority to do so.” As part of the agreement, additional charges against her – obstructing an official proceeding and intent to disrupt the orderly conduct of government business – will be dismissed. She also agreed to cooperate with investigators, including allowing them to review social media postings made during the time surrounding the event.

Shortly after she was indicted, Dr. Gold told The Washington Post that she did not see any violence and that the event was “peaceful.” However, according to news reports, Dr. Gold acknowledged in her plea deal that she and her codefendant, John Herbert Strand, witnessed the assault of a police officer while they were outside the building.

Dr. Gold, 56, based in Beverly Hills, Calif., founded AFD in 2019. The group notes its goal is to “amplify the voices of concerned physicians and patients nationwide to combat those who push political and economic agendas at the expense of science and quality health care solutions.” Mr. Strand is the organization’s communication’s director.

The group has been a leading proponent of the use of ivermectin as a “safe and effective treatment” for COVID-19, according to its website.

In 2021, Dr. Gold spoke at an event called The Stand, representing AFD, where she promised to tell “the truth” about COVID vaccines, including that it was actually giving people the virus, that COVID was renamed from the “Wuhan Virus” as part of a cover-up, and touted treatments, including hydroxycholoroquine and ivermectin.

Dr. Gold has been one of the leading voices in the anti-vaccine movement. She has more than 400,000 Twitter followers; her Twitter profile includes a pinned tweet saying: “We are living in Orwellian times.” In addition to spreading vaccine misinformation, Dr. Gold has promoted the use of unproven treatments such as hydroxychloroquine and ivermectin.

Calls and emails to AFD regarding a statement on Gold’s plea made by this news organization were not returned by press time.

In October, Representative James E. Clyburn (D-S.C.), chairman of the Select Subcommittee on the Coronavirus Crisis, launched an investigation into organizations, including AFD, that spread misinformation and facilitate access to disproven and potentially hazardous treatments for COVID-19. According to news reports, Rep. Clyburn called the AFD and other such groups “predatory actors.”

Hospitals where Dr. Gold previously worked, including Providence St. Joseph Medical Center in Santa Monica, Calif., and Cedars-Sinai in Los Angeles, have disassociated themselves from her. On July 29, 2020, Cedars-Sinai Medical Center, where Gold previously worked, issued a statement that said, in part, “Simone Gold, MD, has not worked with Cedars-Sinai Medical Center or any of its offices or affiliates since 2015. For 3 weeks in late 2015, Dr. Gold was employed on a per diem basis by Cedars-Sinai Medical Network, a component of Cedars-Sinai. She worked during this brief time in a network urgent care clinic. Dr. Gold is not authorized to represent or speak about any information on behalf of Cedars-Sinai.”

Dr. Gold’s medical license in the state of California is current and she has no pending hearings before the state medical board, according to its website. On her own website, Dr. Gold says she “voluntarily refused” to renew her board certification last year, “due to the unethical behavior of the medical boards.”

Dr. Gold is also a licensed attorney, having earned her law degree in health policy analysis at Stanford (Calif.) Law School.

Dr. Gold faces 6 months in prison. Sentencing is scheduled for June 16.

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

California-based emergency physician Simone Melissa Gold, MD, JD, founder of the antivaccine group America’s Frontline Doctors (AFD) and leading voice in the antivaccine movement, has pleaded guilty to one of five charges related to the Jan. 6 Capitol riot.

According to the plea deal, Dr. Gold pleaded guilty to charges that she “did unlawfully and knowingly enter and remain in a restricted building and grounds, that is, any posted, cordoned-off, or otherwise restricted area within the United States Capitol and its grounds, during a time when the vice president was in the building without lawful authority to do so.” As part of the agreement, additional charges against her – obstructing an official proceeding and intent to disrupt the orderly conduct of government business – will be dismissed. She also agreed to cooperate with investigators, including allowing them to review social media postings made during the time surrounding the event.

Shortly after she was indicted, Dr. Gold told The Washington Post that she did not see any violence and that the event was “peaceful.” However, according to news reports, Dr. Gold acknowledged in her plea deal that she and her codefendant, John Herbert Strand, witnessed the assault of a police officer while they were outside the building.

Dr. Gold, 56, based in Beverly Hills, Calif., founded AFD in 2019. The group notes its goal is to “amplify the voices of concerned physicians and patients nationwide to combat those who push political and economic agendas at the expense of science and quality health care solutions.” Mr. Strand is the organization’s communication’s director.

The group has been a leading proponent of the use of ivermectin as a “safe and effective treatment” for COVID-19, according to its website.

In 2021, Dr. Gold spoke at an event called The Stand, representing AFD, where she promised to tell “the truth” about COVID vaccines, including that it was actually giving people the virus, that COVID was renamed from the “Wuhan Virus” as part of a cover-up, and touted treatments, including hydroxycholoroquine and ivermectin.

Dr. Gold has been one of the leading voices in the anti-vaccine movement. She has more than 400,000 Twitter followers; her Twitter profile includes a pinned tweet saying: “We are living in Orwellian times.” In addition to spreading vaccine misinformation, Dr. Gold has promoted the use of unproven treatments such as hydroxychloroquine and ivermectin.

Calls and emails to AFD regarding a statement on Gold’s plea made by this news organization were not returned by press time.

In October, Representative James E. Clyburn (D-S.C.), chairman of the Select Subcommittee on the Coronavirus Crisis, launched an investigation into organizations, including AFD, that spread misinformation and facilitate access to disproven and potentially hazardous treatments for COVID-19. According to news reports, Rep. Clyburn called the AFD and other such groups “predatory actors.”

Hospitals where Dr. Gold previously worked, including Providence St. Joseph Medical Center in Santa Monica, Calif., and Cedars-Sinai in Los Angeles, have disassociated themselves from her. On July 29, 2020, Cedars-Sinai Medical Center, where Gold previously worked, issued a statement that said, in part, “Simone Gold, MD, has not worked with Cedars-Sinai Medical Center or any of its offices or affiliates since 2015. For 3 weeks in late 2015, Dr. Gold was employed on a per diem basis by Cedars-Sinai Medical Network, a component of Cedars-Sinai. She worked during this brief time in a network urgent care clinic. Dr. Gold is not authorized to represent or speak about any information on behalf of Cedars-Sinai.”

Dr. Gold’s medical license in the state of California is current and she has no pending hearings before the state medical board, according to its website. On her own website, Dr. Gold says she “voluntarily refused” to renew her board certification last year, “due to the unethical behavior of the medical boards.”

Dr. Gold is also a licensed attorney, having earned her law degree in health policy analysis at Stanford (Calif.) Law School.

Dr. Gold faces 6 months in prison. Sentencing is scheduled for June 16.

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

California-based emergency physician Simone Melissa Gold, MD, JD, founder of the antivaccine group America’s Frontline Doctors (AFD) and leading voice in the antivaccine movement, has pleaded guilty to one of five charges related to the Jan. 6 Capitol riot.

According to the plea deal, Dr. Gold pleaded guilty to charges that she “did unlawfully and knowingly enter and remain in a restricted building and grounds, that is, any posted, cordoned-off, or otherwise restricted area within the United States Capitol and its grounds, during a time when the vice president was in the building without lawful authority to do so.” As part of the agreement, additional charges against her – obstructing an official proceeding and intent to disrupt the orderly conduct of government business – will be dismissed. She also agreed to cooperate with investigators, including allowing them to review social media postings made during the time surrounding the event.

Shortly after she was indicted, Dr. Gold told The Washington Post that she did not see any violence and that the event was “peaceful.” However, according to news reports, Dr. Gold acknowledged in her plea deal that she and her codefendant, John Herbert Strand, witnessed the assault of a police officer while they were outside the building.

Dr. Gold, 56, based in Beverly Hills, Calif., founded AFD in 2019. The group notes its goal is to “amplify the voices of concerned physicians and patients nationwide to combat those who push political and economic agendas at the expense of science and quality health care solutions.” Mr. Strand is the organization’s communication’s director.

The group has been a leading proponent of the use of ivermectin as a “safe and effective treatment” for COVID-19, according to its website.

In 2021, Dr. Gold spoke at an event called The Stand, representing AFD, where she promised to tell “the truth” about COVID vaccines, including that it was actually giving people the virus, that COVID was renamed from the “Wuhan Virus” as part of a cover-up, and touted treatments, including hydroxycholoroquine and ivermectin.

Dr. Gold has been one of the leading voices in the anti-vaccine movement. She has more than 400,000 Twitter followers; her Twitter profile includes a pinned tweet saying: “We are living in Orwellian times.” In addition to spreading vaccine misinformation, Dr. Gold has promoted the use of unproven treatments such as hydroxychloroquine and ivermectin.

Calls and emails to AFD regarding a statement on Gold’s plea made by this news organization were not returned by press time.

In October, Representative James E. Clyburn (D-S.C.), chairman of the Select Subcommittee on the Coronavirus Crisis, launched an investigation into organizations, including AFD, that spread misinformation and facilitate access to disproven and potentially hazardous treatments for COVID-19. According to news reports, Rep. Clyburn called the AFD and other such groups “predatory actors.”

Hospitals where Dr. Gold previously worked, including Providence St. Joseph Medical Center in Santa Monica, Calif., and Cedars-Sinai in Los Angeles, have disassociated themselves from her. On July 29, 2020, Cedars-Sinai Medical Center, where Gold previously worked, issued a statement that said, in part, “Simone Gold, MD, has not worked with Cedars-Sinai Medical Center or any of its offices or affiliates since 2015. For 3 weeks in late 2015, Dr. Gold was employed on a per diem basis by Cedars-Sinai Medical Network, a component of Cedars-Sinai. She worked during this brief time in a network urgent care clinic. Dr. Gold is not authorized to represent or speak about any information on behalf of Cedars-Sinai.”

Dr. Gold’s medical license in the state of California is current and she has no pending hearings before the state medical board, according to its website. On her own website, Dr. Gold says she “voluntarily refused” to renew her board certification last year, “due to the unethical behavior of the medical boards.”

Dr. Gold is also a licensed attorney, having earned her law degree in health policy analysis at Stanford (Calif.) Law School.

Dr. Gold faces 6 months in prison. Sentencing is scheduled for June 16.

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