Even as the war in Ukraine has prompted an exodus of international companies — from fast-food chains and oil producers to luxury retailers — from Russia, U.S. and global drug companies said they would continue manufacturing and selling their products there.

Airlines, automakers, banks, and technology giants — at least 320 companies by one count — are among the businesses curtailing operations or making high-profile exits from Russia as its invasion of Ukraine intensifies. McDonald’s, Starbucks, and Coca-Cola announced a pause in sales recently.

But drugmakers, medical device manufacturers, and health care companies, which are exempted from U.S. and European sanctions, said Russians need access to medicines and medical equipment and contend that international humanitarian law requires they keep supply chains open.

“As a health care company, we have an important purpose, which is why at this time we continue to serve people in all countries in which we operate who depend on us for essential products, some life-sustaining,” said Scott Stoffel, divisional vice president for Illinois-based Abbott Laboratories, which manufactures and sells medicines in Russia for oncology, women’s health, pancreatic insufficiency, and liver health.

Johnson & Johnson — which has corporate offices in Moscow, Novosibirsk, St. Petersburg, and Yekaterinburg — said in a statement, “We remain committed to providing essential health products to those in need in Ukraine, Russia, and the region, in compliance with current sanctions and while adapting to the rapidly changing situation on the ground.”

The reluctance of drugmakers to pause operations in Russia is being met with a growing chorus of criticism.

Pharmaceutical companies that say they must continue to manufacture drugs in Russia for humanitarian reasons are “being misguided at best, cynical in the medium case, and outright deplorably misleading and deceptive,” said Jeffrey Sonnenfeld, DBA, a professor at the Yale School of Management who is tracking which companies have curtailed operations in Russia. He noted that banks and technology companies also provide essential services.

“Russians are put in a tragic position of unearned suffering. If we continue to make life palatable for them, then we are continuing to support the regime,” Dr. Sonnenfeld said. “These drug companies will be seen as complicit with the most vicious operation on the planet. Instead of protecting life, they are going to be seen as destroying life. The goal here is to show that Putin is not in control of all sectors of the economy.”

U.S. pharmaceutical and medical companies have operated in Russia for decades, and many ramped up operations after Russia invaded and annexed Crimea in 2014, navigating the fraught relationship between the United States and Russia amid sanctions. In 2010, Vladimir Putin, then Russian prime minister, announced an ambitious national plan for the Russian pharmaceutical industry that would be a pillar in his efforts to reestablish his country as an influential superpower and wean the country off Western pharmaceutical imports. Under the plan, called “Pharma-2020” and “Pharma-2030,” the government required Western pharmaceutical companies eager to sell to Russia’s growing middle class to locate production inside the country.

Pfizer, Johnson & Johnson, Novartis, and Abbott are among the drugmakers that manufacture pharmaceutical drugs at facilities in St. Petersburg and elsewhere in the country and typically sell those drugs as branded generics or under Russian brands.

Pfizer’s CEO, Albert Bourla, said on CBS that the giant drugmaker is not going to make further investments in Russia, but that it will not cut ties with Russia, as multinational companies in other industries are doing.

Pharmaceutical manufacturing plants in Kaluga, a major manufacturing center for Volkswagen and Volvo southwest of Moscow, have been funded through a partnership between Rusnano, a state-owned venture that promotes the development of high-tech enterprises, and U.S. venture capital firms.

Russia also has sought to position itself as an attractive research market, offering an inexpensive and lax regulatory environment for clinical drug trials. Last year, Pfizer conducted in Russia clinical trials of Paxlovid, its experimental antiviral pill to treat covid-19. Before the invasion began in late February, 3,072 trials were underway in Russia and 503 were underway in Ukraine, according to BioWorld, a reporting hub focused on drug development that features data from Cortellis.

AstraZeneca is the top sponsor of clinical trials in Russia, with 49 trials, followed by a subsidiary of Merck, with 48 trials.

So far, drugmakers’ response to the Ukraine invasion has largely centered on public pledges to donate essential medicines and vaccines to Ukrainian patients and refugees. They’ve also made general comments about the need to keep open the supply of medicines flowing within Russia.

Abbott has pledged $2 million to support humanitarian efforts in Ukraine, and Pfizer, based in New York, said it has supplied $1 million in humanitarian grants. Swiss drug maker Novartis said it was expanding humanitarian efforts in Ukraine and working to “ensure the continued supply of our medicines in Ukraine.”

But no major pharmaceutical or medical device maker has announced plans to shutter manufacturing plants or halt sales inside Russia.

In an open letter, hundreds of leaders of mainly smaller biotechnology companies have called on industry members to cease business activities in Russia, including “investment in Russian companies and new investment within the borders of Russia,” and to halt trade and collaboration with Russian companies, except for supplying food and medicines. How many of the signatories have business operations in Russia was unclear.

Ulrich Neumann, director for market access at Janssen, a Johnson & Johnson company, was among those who signed the letter, but whether he was speaking for the company was unclear. In its own statement posted on social media, the company said it’s “committed to providing access to our essential medical products in the countries where we operate, in compliance with current international sanctions.”

GlaxoSmithKline, headquartered in the United Kingdom, said in a statement that it’s stopping all advertising in Russia and will not enter into contracts that “directly support the Russian administration or military.” But the company said that as a “supplier of needed medicines, vaccines and everyday health products, we have a responsibility to do all we can to make them available. For this reason, we will continue to supply our products to the people of Russia, while we can.”

Nell Minow, vice chair of ValueEdge Advisors, an investment consulting firm, noted that drug companies have been treated differently than other industries during previous global conflicts. For example, some corporate ethicists advised against pharmaceutical companies’ total divestment from South Africa’s apartheid regime to ensure essential medicines flowed to the country.

“There is a difference between a hamburger and a pill,” Mr. Minow said. Companies should strongly condemn Russia’s actions, she said, but unless the United States enters directly into a war with Russia, companies that make essential medicines and health care products should continue to operate. Before U.S. involvement in World War II, she added, there were “some American companies that did business with Germany until the last minute.”
 

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation. KHN senior correspondent Arthur Allen contributed to this article.

Even as the war in Ukraine has prompted an exodus of international companies — from fast-food chains and oil producers to luxury retailers — from Russia, U.S. and global drug companies said they would continue manufacturing and selling their products there.

Airlines, automakers, banks, and technology giants — at least 320 companies by one count — are among the businesses curtailing operations or making high-profile exits from Russia as its invasion of Ukraine intensifies. McDonald’s, Starbucks, and Coca-Cola announced a pause in sales recently.

But drugmakers, medical device manufacturers, and health care companies, which are exempted from U.S. and European sanctions, said Russians need access to medicines and medical equipment and contend that international humanitarian law requires they keep supply chains open.

“As a health care company, we have an important purpose, which is why at this time we continue to serve people in all countries in which we operate who depend on us for essential products, some life-sustaining,” said Scott Stoffel, divisional vice president for Illinois-based Abbott Laboratories, which manufactures and sells medicines in Russia for oncology, women’s health, pancreatic insufficiency, and liver health.

Johnson & Johnson — which has corporate offices in Moscow, Novosibirsk, St. Petersburg, and Yekaterinburg — said in a statement, “We remain committed to providing essential health products to those in need in Ukraine, Russia, and the region, in compliance with current sanctions and while adapting to the rapidly changing situation on the ground.”

The reluctance of drugmakers to pause operations in Russia is being met with a growing chorus of criticism.

Pharmaceutical companies that say they must continue to manufacture drugs in Russia for humanitarian reasons are “being misguided at best, cynical in the medium case, and outright deplorably misleading and deceptive,” said Jeffrey Sonnenfeld, DBA, a professor at the Yale School of Management who is tracking which companies have curtailed operations in Russia. He noted that banks and technology companies also provide essential services.

“Russians are put in a tragic position of unearned suffering. If we continue to make life palatable for them, then we are continuing to support the regime,” Dr. Sonnenfeld said. “These drug companies will be seen as complicit with the most vicious operation on the planet. Instead of protecting life, they are going to be seen as destroying life. The goal here is to show that Putin is not in control of all sectors of the economy.”

U.S. pharmaceutical and medical companies have operated in Russia for decades, and many ramped up operations after Russia invaded and annexed Crimea in 2014, navigating the fraught relationship between the United States and Russia amid sanctions. In 2010, Vladimir Putin, then Russian prime minister, announced an ambitious national plan for the Russian pharmaceutical industry that would be a pillar in his efforts to reestablish his country as an influential superpower and wean the country off Western pharmaceutical imports. Under the plan, called “Pharma-2020” and “Pharma-2030,” the government required Western pharmaceutical companies eager to sell to Russia’s growing middle class to locate production inside the country.

Pfizer, Johnson & Johnson, Novartis, and Abbott are among the drugmakers that manufacture pharmaceutical drugs at facilities in St. Petersburg and elsewhere in the country and typically sell those drugs as branded generics or under Russian brands.

Pfizer’s CEO, Albert Bourla, said on CBS that the giant drugmaker is not going to make further investments in Russia, but that it will not cut ties with Russia, as multinational companies in other industries are doing.

Pharmaceutical manufacturing plants in Kaluga, a major manufacturing center for Volkswagen and Volvo southwest of Moscow, have been funded through a partnership between Rusnano, a state-owned venture that promotes the development of high-tech enterprises, and U.S. venture capital firms.

Russia also has sought to position itself as an attractive research market, offering an inexpensive and lax regulatory environment for clinical drug trials. Last year, Pfizer conducted in Russia clinical trials of Paxlovid, its experimental antiviral pill to treat covid-19. Before the invasion began in late February, 3,072 trials were underway in Russia and 503 were underway in Ukraine, according to BioWorld, a reporting hub focused on drug development that features data from Cortellis.

AstraZeneca is the top sponsor of clinical trials in Russia, with 49 trials, followed by a subsidiary of Merck, with 48 trials.

So far, drugmakers’ response to the Ukraine invasion has largely centered on public pledges to donate essential medicines and vaccines to Ukrainian patients and refugees. They’ve also made general comments about the need to keep open the supply of medicines flowing within Russia.

Abbott has pledged $2 million to support humanitarian efforts in Ukraine, and Pfizer, based in New York, said it has supplied $1 million in humanitarian grants. Swiss drug maker Novartis said it was expanding humanitarian efforts in Ukraine and working to “ensure the continued supply of our medicines in Ukraine.”

But no major pharmaceutical or medical device maker has announced plans to shutter manufacturing plants or halt sales inside Russia.

In an open letter, hundreds of leaders of mainly smaller biotechnology companies have called on industry members to cease business activities in Russia, including “investment in Russian companies and new investment within the borders of Russia,” and to halt trade and collaboration with Russian companies, except for supplying food and medicines. How many of the signatories have business operations in Russia was unclear.

Ulrich Neumann, director for market access at Janssen, a Johnson & Johnson company, was among those who signed the letter, but whether he was speaking for the company was unclear. In its own statement posted on social media, the company said it’s “committed to providing access to our essential medical products in the countries where we operate, in compliance with current international sanctions.”

GlaxoSmithKline, headquartered in the United Kingdom, said in a statement that it’s stopping all advertising in Russia and will not enter into contracts that “directly support the Russian administration or military.” But the company said that as a “supplier of needed medicines, vaccines and everyday health products, we have a responsibility to do all we can to make them available. For this reason, we will continue to supply our products to the people of Russia, while we can.”

Nell Minow, vice chair of ValueEdge Advisors, an investment consulting firm, noted that drug companies have been treated differently than other industries during previous global conflicts. For example, some corporate ethicists advised against pharmaceutical companies’ total divestment from South Africa’s apartheid regime to ensure essential medicines flowed to the country.

“There is a difference between a hamburger and a pill,” Mr. Minow said. Companies should strongly condemn Russia’s actions, she said, but unless the United States enters directly into a war with Russia, companies that make essential medicines and health care products should continue to operate. Before U.S. involvement in World War II, she added, there were “some American companies that did business with Germany until the last minute.”
 

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation. KHN senior correspondent Arthur Allen contributed to this article.

Even as the war in Ukraine has prompted an exodus of international companies — from fast-food chains and oil producers to luxury retailers — from Russia, U.S. and global drug companies said they would continue manufacturing and selling their products there.

Airlines, automakers, banks, and technology giants — at least 320 companies by one count — are among the businesses curtailing operations or making high-profile exits from Russia as its invasion of Ukraine intensifies. McDonald’s, Starbucks, and Coca-Cola announced a pause in sales recently.

But drugmakers, medical device manufacturers, and health care companies, which are exempted from U.S. and European sanctions, said Russians need access to medicines and medical equipment and contend that international humanitarian law requires they keep supply chains open.

“As a health care company, we have an important purpose, which is why at this time we continue to serve people in all countries in which we operate who depend on us for essential products, some life-sustaining,” said Scott Stoffel, divisional vice president for Illinois-based Abbott Laboratories, which manufactures and sells medicines in Russia for oncology, women’s health, pancreatic insufficiency, and liver health.

Johnson & Johnson — which has corporate offices in Moscow, Novosibirsk, St. Petersburg, and Yekaterinburg — said in a statement, “We remain committed to providing essential health products to those in need in Ukraine, Russia, and the region, in compliance with current sanctions and while adapting to the rapidly changing situation on the ground.”

The reluctance of drugmakers to pause operations in Russia is being met with a growing chorus of criticism.

Pharmaceutical companies that say they must continue to manufacture drugs in Russia for humanitarian reasons are “being misguided at best, cynical in the medium case, and outright deplorably misleading and deceptive,” said Jeffrey Sonnenfeld, DBA, a professor at the Yale School of Management who is tracking which companies have curtailed operations in Russia. He noted that banks and technology companies also provide essential services.

“Russians are put in a tragic position of unearned suffering. If we continue to make life palatable for them, then we are continuing to support the regime,” Dr. Sonnenfeld said. “These drug companies will be seen as complicit with the most vicious operation on the planet. Instead of protecting life, they are going to be seen as destroying life. The goal here is to show that Putin is not in control of all sectors of the economy.”

U.S. pharmaceutical and medical companies have operated in Russia for decades, and many ramped up operations after Russia invaded and annexed Crimea in 2014, navigating the fraught relationship between the United States and Russia amid sanctions. In 2010, Vladimir Putin, then Russian prime minister, announced an ambitious national plan for the Russian pharmaceutical industry that would be a pillar in his efforts to reestablish his country as an influential superpower and wean the country off Western pharmaceutical imports. Under the plan, called “Pharma-2020” and “Pharma-2030,” the government required Western pharmaceutical companies eager to sell to Russia’s growing middle class to locate production inside the country.

Pfizer, Johnson & Johnson, Novartis, and Abbott are among the drugmakers that manufacture pharmaceutical drugs at facilities in St. Petersburg and elsewhere in the country and typically sell those drugs as branded generics or under Russian brands.

Pfizer’s CEO, Albert Bourla, said on CBS that the giant drugmaker is not going to make further investments in Russia, but that it will not cut ties with Russia, as multinational companies in other industries are doing.

Pharmaceutical manufacturing plants in Kaluga, a major manufacturing center for Volkswagen and Volvo southwest of Moscow, have been funded through a partnership between Rusnano, a state-owned venture that promotes the development of high-tech enterprises, and U.S. venture capital firms.

Russia also has sought to position itself as an attractive research market, offering an inexpensive and lax regulatory environment for clinical drug trials. Last year, Pfizer conducted in Russia clinical trials of Paxlovid, its experimental antiviral pill to treat covid-19. Before the invasion began in late February, 3,072 trials were underway in Russia and 503 were underway in Ukraine, according to BioWorld, a reporting hub focused on drug development that features data from Cortellis.

AstraZeneca is the top sponsor of clinical trials in Russia, with 49 trials, followed by a subsidiary of Merck, with 48 trials.

So far, drugmakers’ response to the Ukraine invasion has largely centered on public pledges to donate essential medicines and vaccines to Ukrainian patients and refugees. They’ve also made general comments about the need to keep open the supply of medicines flowing within Russia.

Abbott has pledged $2 million to support humanitarian efforts in Ukraine, and Pfizer, based in New York, said it has supplied $1 million in humanitarian grants. Swiss drug maker Novartis said it was expanding humanitarian efforts in Ukraine and working to “ensure the continued supply of our medicines in Ukraine.”

But no major pharmaceutical or medical device maker has announced plans to shutter manufacturing plants or halt sales inside Russia.

In an open letter, hundreds of leaders of mainly smaller biotechnology companies have called on industry members to cease business activities in Russia, including “investment in Russian companies and new investment within the borders of Russia,” and to halt trade and collaboration with Russian companies, except for supplying food and medicines. How many of the signatories have business operations in Russia was unclear.

Ulrich Neumann, director for market access at Janssen, a Johnson & Johnson company, was among those who signed the letter, but whether he was speaking for the company was unclear. In its own statement posted on social media, the company said it’s “committed to providing access to our essential medical products in the countries where we operate, in compliance with current international sanctions.”

GlaxoSmithKline, headquartered in the United Kingdom, said in a statement that it’s stopping all advertising in Russia and will not enter into contracts that “directly support the Russian administration or military.” But the company said that as a “supplier of needed medicines, vaccines and everyday health products, we have a responsibility to do all we can to make them available. For this reason, we will continue to supply our products to the people of Russia, while we can.”

Nell Minow, vice chair of ValueEdge Advisors, an investment consulting firm, noted that drug companies have been treated differently than other industries during previous global conflicts. For example, some corporate ethicists advised against pharmaceutical companies’ total divestment from South Africa’s apartheid regime to ensure essential medicines flowed to the country.

“There is a difference between a hamburger and a pill,” Mr. Minow said. Companies should strongly condemn Russia’s actions, she said, but unless the United States enters directly into a war with Russia, companies that make essential medicines and health care products should continue to operate. Before U.S. involvement in World War II, she added, there were “some American companies that did business with Germany until the last minute.”
 

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation. KHN senior correspondent Arthur Allen contributed to this article.

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.

Heterosexuals with HIV have lower CD4 counts at diagnosis than their gay and bisexual male peers, according to an analysis of more than 300,000 people living with HIV globally.

“It was quite a startling finding for us, because it’s now telling everybody, ‘Look, if you have MSM [men who have sex with men] coming into your clinic, expect CD4 counts at diagnosis to be higher than if the person got the infection as a heterosexual,’” Narendra Dixit, PhD, senior fellow at the Indian Institute of Science’s Centre for Biosystems Science and Engineering, Bangalore, India, said in an interview.

And that means, he said, that the pattern may appear in local clinics.

“If they find that there are differences in the CD4 counts between heterosexuals and MSMs, they should not be surprised anymore,” he said.

Dr. Dixit proposed that the reason for this may be that the viruses transmitted among heterosexuals are more virulent, but the study didn’t provide evidence of that.
 

Immune health at HIV diagnosis

In this study, which was published online March 10 in PLOS Pathogens, Dr. Dixit and colleague Anathu James, PhD, a data scientist and an epidemiologist at the Indian Institute of Science, culled data from 337,119 people captured in studies in the United Kingdom, the United States, Europe, Australia, and China. For all participants, CD4 counts were drawn at the time of diagnosis and before starting HIV treatment. Dr. Dixit and Dr. James then divided the studies by HIV transmission group – gay and bisexual men versus heterosexuals – and then averaged CD4 counts in each study.

Then they created a mathematical model to estimate how quickly each group might progress to an AIDS-defining illness, given those initial CD4 counts.

What they found was that the mean CD4 count was consistently higher in the gay and bisexual males than in the heterosexuals, no matter where they lived. For instance, mean CD4 counts at diagnosis were a mean of 437 cells/mm³ among gay and bisexual men in one European cohort, compared to a mean of 307 among heterosexuals. In the U.S. data, the mean CD4 count for gay and bisexual men was 390, compared to 314 among heterosexuals. In China, the same held true: Gay men had a mean CD4 count of 368 cells/mm³; heterosexuals had a mean CD4 count of 270.

This remained true when they only looked at people between the ages of 13 and 29 years in the United States or whether they were younger than 40 in Europe and Australia. In Europe and Australia, though, heterosexual women younger than 40 had higher CD4 counts than either straight or gay men. But this difference did not reach statistical significance, and gay men had higher CD4 counts overall when the investigators didn’t segregate the data by age group.

“We were stunned,” Dr. Dixit told this news organization. “People never thought there could be a difference in the CD4 counts just because the mode of transmission is different – or, in this case, because the risk groups are different.”

There was no difference, though, in viral load at diagnosis.

In their mathematical model on progression to AIDS, the investigators estimated that these lower CD4 counts at diagnosis would lead to a progression to AIDS that was 19% higher for straight people than for gay and bisexual men. What this implies for practice is less clear. Right now, Dr. Dixit hopes the data will be used to conduct molecular analysis of HIV strains in heterosexuals and gay and bisexual men to see if the HIV circulating in straight communities is different – and perhaps more virulent – than the HIV circulating among gay and bisexual men. Previous research has suggested that CD4 counts can be used as a proxy for virulence.

Dr. Dixit’s mathematical model follows recent news of a highly virulent strain of HIV that’s been present in the Netherlands for decades. “More virulent” in that case meant that it was more highly transmissible and led to higher viral loads and a quicker decline of the immune CD4 cells. So when news of Dr. Dixit’s study went out, it was accompanied by a press release stating as fact that “HIV-1 infections are more virulent when transmitted through penile-vaginal intercourse.” The study’s title states that HIV is “more virulent” in heterosexuals.

But this study doesn’t actually show that, said virology researcher Timothy Henrich, MD, associate professor of medicine at the University of California, San Francisco, in an interview. In the Netherlands study, investigators took the additional step of analyzing HIV genomes. But this was not done in the recent PLOS Pathogens study.

“This was essentially a large meta-analysis of multiple large cohorts across many different countries,” said Dr. Henrich, who was not involved in the study. “There was no in-depth sequence analysis to say, ‘Oh yeah, this is because of a difference in the viruses that are being transmitted.’ If I were reviewing this paper, I probably would have said, ‘This is an interesting observation, but please don’t go overboard in your conclusions.’”

The study made Dr. Henrich want to know more. For instance, what method did each study use to determine CD4 counts? Did they control for the length of time since acquisition? Dr. Henrich said that if they didn’t differentiate between acute infection and chronic infection, he wasn’t sure what conclusions could be drawn from the data. Dr. Dixit told this news organization that they used the plateau level – the point after acute infection when CD4 counts settle into a consistent level. But it’s unclear how far from HIV acquisition each of the people in these studies was.

What Dr. Henrich does know, he said, is that big data are going to continue to change how we think about and investigate HIV transmission and virulence and what it could mean for clinical practice. The National Institutes of Health, for instance, will soon require all researchers receiving their funding to make their raw data publicly available soon after publication.

“We’re going to see a lot more of these large studies going forward,” he said. And if molecular analyses bear out Dr. Dixit’s conclusion – which he called “a big if” – “maybe we could use this study as a way” to do this work in the future.

The study was funded by DBT Network and the Wellcome Trust India Alliance Senior Fellowship. Dr. Dixit has disclosed no relevant financial relationships. Dr. Henrich is conducting studies funded in whole or in part by Merck and Gilead Sciences.

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

Heterosexuals with HIV have lower CD4 counts at diagnosis than their gay and bisexual male peers, according to an analysis of more than 300,000 people living with HIV globally.

“It was quite a startling finding for us, because it’s now telling everybody, ‘Look, if you have MSM [men who have sex with men] coming into your clinic, expect CD4 counts at diagnosis to be higher than if the person got the infection as a heterosexual,’” Narendra Dixit, PhD, senior fellow at the Indian Institute of Science’s Centre for Biosystems Science and Engineering, Bangalore, India, said in an interview.

And that means, he said, that the pattern may appear in local clinics.

“If they find that there are differences in the CD4 counts between heterosexuals and MSMs, they should not be surprised anymore,” he said.

Dr. Dixit proposed that the reason for this may be that the viruses transmitted among heterosexuals are more virulent, but the study didn’t provide evidence of that.
 

Immune health at HIV diagnosis

In this study, which was published online March 10 in PLOS Pathogens, Dr. Dixit and colleague Anathu James, PhD, a data scientist and an epidemiologist at the Indian Institute of Science, culled data from 337,119 people captured in studies in the United Kingdom, the United States, Europe, Australia, and China. For all participants, CD4 counts were drawn at the time of diagnosis and before starting HIV treatment. Dr. Dixit and Dr. James then divided the studies by HIV transmission group – gay and bisexual men versus heterosexuals – and then averaged CD4 counts in each study.

Then they created a mathematical model to estimate how quickly each group might progress to an AIDS-defining illness, given those initial CD4 counts.

What they found was that the mean CD4 count was consistently higher in the gay and bisexual males than in the heterosexuals, no matter where they lived. For instance, mean CD4 counts at diagnosis were a mean of 437 cells/mm³ among gay and bisexual men in one European cohort, compared to a mean of 307 among heterosexuals. In the U.S. data, the mean CD4 count for gay and bisexual men was 390, compared to 314 among heterosexuals. In China, the same held true: Gay men had a mean CD4 count of 368 cells/mm³; heterosexuals had a mean CD4 count of 270.

This remained true when they only looked at people between the ages of 13 and 29 years in the United States or whether they were younger than 40 in Europe and Australia. In Europe and Australia, though, heterosexual women younger than 40 had higher CD4 counts than either straight or gay men. But this difference did not reach statistical significance, and gay men had higher CD4 counts overall when the investigators didn’t segregate the data by age group.

“We were stunned,” Dr. Dixit told this news organization. “People never thought there could be a difference in the CD4 counts just because the mode of transmission is different – or, in this case, because the risk groups are different.”

There was no difference, though, in viral load at diagnosis.

In their mathematical model on progression to AIDS, the investigators estimated that these lower CD4 counts at diagnosis would lead to a progression to AIDS that was 19% higher for straight people than for gay and bisexual men. What this implies for practice is less clear. Right now, Dr. Dixit hopes the data will be used to conduct molecular analysis of HIV strains in heterosexuals and gay and bisexual men to see if the HIV circulating in straight communities is different – and perhaps more virulent – than the HIV circulating among gay and bisexual men. Previous research has suggested that CD4 counts can be used as a proxy for virulence.

Dr. Dixit’s mathematical model follows recent news of a highly virulent strain of HIV that’s been present in the Netherlands for decades. “More virulent” in that case meant that it was more highly transmissible and led to higher viral loads and a quicker decline of the immune CD4 cells. So when news of Dr. Dixit’s study went out, it was accompanied by a press release stating as fact that “HIV-1 infections are more virulent when transmitted through penile-vaginal intercourse.” The study’s title states that HIV is “more virulent” in heterosexuals.

But this study doesn’t actually show that, said virology researcher Timothy Henrich, MD, associate professor of medicine at the University of California, San Francisco, in an interview. In the Netherlands study, investigators took the additional step of analyzing HIV genomes. But this was not done in the recent PLOS Pathogens study.

“This was essentially a large meta-analysis of multiple large cohorts across many different countries,” said Dr. Henrich, who was not involved in the study. “There was no in-depth sequence analysis to say, ‘Oh yeah, this is because of a difference in the viruses that are being transmitted.’ If I were reviewing this paper, I probably would have said, ‘This is an interesting observation, but please don’t go overboard in your conclusions.’”

The study made Dr. Henrich want to know more. For instance, what method did each study use to determine CD4 counts? Did they control for the length of time since acquisition? Dr. Henrich said that if they didn’t differentiate between acute infection and chronic infection, he wasn’t sure what conclusions could be drawn from the data. Dr. Dixit told this news organization that they used the plateau level – the point after acute infection when CD4 counts settle into a consistent level. But it’s unclear how far from HIV acquisition each of the people in these studies was.

What Dr. Henrich does know, he said, is that big data are going to continue to change how we think about and investigate HIV transmission and virulence and what it could mean for clinical practice. The National Institutes of Health, for instance, will soon require all researchers receiving their funding to make their raw data publicly available soon after publication.

“We’re going to see a lot more of these large studies going forward,” he said. And if molecular analyses bear out Dr. Dixit’s conclusion – which he called “a big if” – “maybe we could use this study as a way” to do this work in the future.

The study was funded by DBT Network and the Wellcome Trust India Alliance Senior Fellowship. Dr. Dixit has disclosed no relevant financial relationships. Dr. Henrich is conducting studies funded in whole or in part by Merck and Gilead Sciences.

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

Heterosexuals with HIV have lower CD4 counts at diagnosis than their gay and bisexual male peers, according to an analysis of more than 300,000 people living with HIV globally.

“It was quite a startling finding for us, because it’s now telling everybody, ‘Look, if you have MSM [men who have sex with men] coming into your clinic, expect CD4 counts at diagnosis to be higher than if the person got the infection as a heterosexual,’” Narendra Dixit, PhD, senior fellow at the Indian Institute of Science’s Centre for Biosystems Science and Engineering, Bangalore, India, said in an interview.

And that means, he said, that the pattern may appear in local clinics.

“If they find that there are differences in the CD4 counts between heterosexuals and MSMs, they should not be surprised anymore,” he said.

Dr. Dixit proposed that the reason for this may be that the viruses transmitted among heterosexuals are more virulent, but the study didn’t provide evidence of that.
 

Immune health at HIV diagnosis

In this study, which was published online March 10 in PLOS Pathogens, Dr. Dixit and colleague Anathu James, PhD, a data scientist and an epidemiologist at the Indian Institute of Science, culled data from 337,119 people captured in studies in the United Kingdom, the United States, Europe, Australia, and China. For all participants, CD4 counts were drawn at the time of diagnosis and before starting HIV treatment. Dr. Dixit and Dr. James then divided the studies by HIV transmission group – gay and bisexual men versus heterosexuals – and then averaged CD4 counts in each study.

Then they created a mathematical model to estimate how quickly each group might progress to an AIDS-defining illness, given those initial CD4 counts.

What they found was that the mean CD4 count was consistently higher in the gay and bisexual males than in the heterosexuals, no matter where they lived. For instance, mean CD4 counts at diagnosis were a mean of 437 cells/mm³ among gay and bisexual men in one European cohort, compared to a mean of 307 among heterosexuals. In the U.S. data, the mean CD4 count for gay and bisexual men was 390, compared to 314 among heterosexuals. In China, the same held true: Gay men had a mean CD4 count of 368 cells/mm³; heterosexuals had a mean CD4 count of 270.

This remained true when they only looked at people between the ages of 13 and 29 years in the United States or whether they were younger than 40 in Europe and Australia. In Europe and Australia, though, heterosexual women younger than 40 had higher CD4 counts than either straight or gay men. But this difference did not reach statistical significance, and gay men had higher CD4 counts overall when the investigators didn’t segregate the data by age group.

“We were stunned,” Dr. Dixit told this news organization. “People never thought there could be a difference in the CD4 counts just because the mode of transmission is different – or, in this case, because the risk groups are different.”

There was no difference, though, in viral load at diagnosis.

In their mathematical model on progression to AIDS, the investigators estimated that these lower CD4 counts at diagnosis would lead to a progression to AIDS that was 19% higher for straight people than for gay and bisexual men. What this implies for practice is less clear. Right now, Dr. Dixit hopes the data will be used to conduct molecular analysis of HIV strains in heterosexuals and gay and bisexual men to see if the HIV circulating in straight communities is different – and perhaps more virulent – than the HIV circulating among gay and bisexual men. Previous research has suggested that CD4 counts can be used as a proxy for virulence.

Dr. Dixit’s mathematical model follows recent news of a highly virulent strain of HIV that’s been present in the Netherlands for decades. “More virulent” in that case meant that it was more highly transmissible and led to higher viral loads and a quicker decline of the immune CD4 cells. So when news of Dr. Dixit’s study went out, it was accompanied by a press release stating as fact that “HIV-1 infections are more virulent when transmitted through penile-vaginal intercourse.” The study’s title states that HIV is “more virulent” in heterosexuals.

But this study doesn’t actually show that, said virology researcher Timothy Henrich, MD, associate professor of medicine at the University of California, San Francisco, in an interview. In the Netherlands study, investigators took the additional step of analyzing HIV genomes. But this was not done in the recent PLOS Pathogens study.

“This was essentially a large meta-analysis of multiple large cohorts across many different countries,” said Dr. Henrich, who was not involved in the study. “There was no in-depth sequence analysis to say, ‘Oh yeah, this is because of a difference in the viruses that are being transmitted.’ If I were reviewing this paper, I probably would have said, ‘This is an interesting observation, but please don’t go overboard in your conclusions.’”

The study made Dr. Henrich want to know more. For instance, what method did each study use to determine CD4 counts? Did they control for the length of time since acquisition? Dr. Henrich said that if they didn’t differentiate between acute infection and chronic infection, he wasn’t sure what conclusions could be drawn from the data. Dr. Dixit told this news organization that they used the plateau level – the point after acute infection when CD4 counts settle into a consistent level. But it’s unclear how far from HIV acquisition each of the people in these studies was.

What Dr. Henrich does know, he said, is that big data are going to continue to change how we think about and investigate HIV transmission and virulence and what it could mean for clinical practice. The National Institutes of Health, for instance, will soon require all researchers receiving their funding to make their raw data publicly available soon after publication.

“We’re going to see a lot more of these large studies going forward,” he said. And if molecular analyses bear out Dr. Dixit’s conclusion – which he called “a big if” – “maybe we could use this study as a way” to do this work in the future.

The study was funded by DBT Network and the Wellcome Trust India Alliance Senior Fellowship. Dr. Dixit has disclosed no relevant financial relationships. Dr. Henrich is conducting studies funded in whole or in part by Merck and Gilead Sciences.

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

New recommendations from the American Gastroenterological Association focus on choice of systemic therapy in hepatocellular carcinoma (HCC) patients. The guideline authors point out that prognosis and treatment decisions are both heavily dependent on a combination of the severity of underlying disease and biological characteristics of the tumor.

The document includes options for patients who are ineligible for locoregional therapy or resection, patients with metastatic disease and preserved liver function, patients with poor liver function, and patients receiving adjuvant therapy following surgery or locoregional therapy (LRT).

Intermediate or advanced tumor stage is common among HCC patients, and curative options such as surgery and ablation are generally limited to early-stage disease. LRTs – including transarterial chemoembolization (TACE), transarterial radioembolization (TARE), and systemic therapy – may be employed against advanced or metastatic HCC, according to the authors, led by Grace L. Su, MD, of the division of gastroenterology and hepatology at the University of Michigan, Ann Arbor, and the Veterans Affairs Ann Arbor Healthcare System.

In 2007, the Food and Drug Administration approved the multikinase inhibitor sorafenib as the first systemic therapy for HCC. The new guideline comes in the wake of new systemic therapeutic options that have arrived in the years since, including molecularly targeted therapy and immunotherapy. The authors of the guidance, published in Gastroenterology, include advice on both first- and second-line therapies.

Certainty of evidence for the recommendations ranges from low to very low, indicating limited or very little confidence in the effect estimated, and the true effect is likely to be considerably different than predicted by best current estimates. Accordingly, the recommendations are conditional, and decisions should be made with the values and preferences of the individual patient in mind.

In patients with preserved liver function who are ineligible for LRT or resection, or who have metastatic disease, the authors suggest that first-line treatment should be the combination of atezolizumab and bevacizumab rather than sorafenib. Bevacizumab comes with a bleeding risk, so patients should first be evaluated endoscopically and treated for esophageal varices. For patients who are ineligible for bevacizumab, alternatives are lenvatinib or sorafenib. Patients who are more concerned about disease progression than adverse events may want to consider lenvatinib rather than sorafenib, while those concerned about blood pressure control and who are less concerned about adverse skin reactions may choose sorafenib.

Options for second-line therapy after sorafenib include cabozantinib (mortality reduction, 2.2 months) and pembrolizumab (mortality reduction, 3.3 months). Patients with alpha-fetoprotein levels higher than 400 ng/mL may be candidates for treatment with ramucirumab (mortality reduction, 1.2 months). Another option is regorafenib (mortality reduction, 2.8 months). Patients who are more concerned about adverse effects than a potential survival benefit with any of these therapies may reasonably choose no systemic therapy.

For HCC patients with poor liver function, who are not eligible for LRT or resection, or with metastatic disease, the guidelines recommend against routine use of sorafenib.

In the setting of adjuvant therapy following curative surgical resection, curative local ablation, or TACE LRT, the guidelines recommend against the use of sorafenib. The authors also recommended against the use of bevacizumab following TACE LRT.

The authors noted that there is no high-quality comparative evidence in the second-line setting for atezolizumab plus bevacizumab, sorafenib, or lenvatinib. There is a dearth of evidence and few biomarkers to guide personalization of therapies, which places the emphasis on patient preferences, risks, and benefits.

The authors disclosed no conflicts.

New recommendations from the American Gastroenterological Association focus on choice of systemic therapy in hepatocellular carcinoma (HCC) patients. The guideline authors point out that prognosis and treatment decisions are both heavily dependent on a combination of the severity of underlying disease and biological characteristics of the tumor.

The document includes options for patients who are ineligible for locoregional therapy or resection, patients with metastatic disease and preserved liver function, patients with poor liver function, and patients receiving adjuvant therapy following surgery or locoregional therapy (LRT).

Intermediate or advanced tumor stage is common among HCC patients, and curative options such as surgery and ablation are generally limited to early-stage disease. LRTs – including transarterial chemoembolization (TACE), transarterial radioembolization (TARE), and systemic therapy – may be employed against advanced or metastatic HCC, according to the authors, led by Grace L. Su, MD, of the division of gastroenterology and hepatology at the University of Michigan, Ann Arbor, and the Veterans Affairs Ann Arbor Healthcare System.

In 2007, the Food and Drug Administration approved the multikinase inhibitor sorafenib as the first systemic therapy for HCC. The new guideline comes in the wake of new systemic therapeutic options that have arrived in the years since, including molecularly targeted therapy and immunotherapy. The authors of the guidance, published in Gastroenterology, include advice on both first- and second-line therapies.

Certainty of evidence for the recommendations ranges from low to very low, indicating limited or very little confidence in the effect estimated, and the true effect is likely to be considerably different than predicted by best current estimates. Accordingly, the recommendations are conditional, and decisions should be made with the values and preferences of the individual patient in mind.

In patients with preserved liver function who are ineligible for LRT or resection, or who have metastatic disease, the authors suggest that first-line treatment should be the combination of atezolizumab and bevacizumab rather than sorafenib. Bevacizumab comes with a bleeding risk, so patients should first be evaluated endoscopically and treated for esophageal varices. For patients who are ineligible for bevacizumab, alternatives are lenvatinib or sorafenib. Patients who are more concerned about disease progression than adverse events may want to consider lenvatinib rather than sorafenib, while those concerned about blood pressure control and who are less concerned about adverse skin reactions may choose sorafenib.

Options for second-line therapy after sorafenib include cabozantinib (mortality reduction, 2.2 months) and pembrolizumab (mortality reduction, 3.3 months). Patients with alpha-fetoprotein levels higher than 400 ng/mL may be candidates for treatment with ramucirumab (mortality reduction, 1.2 months). Another option is regorafenib (mortality reduction, 2.8 months). Patients who are more concerned about adverse effects than a potential survival benefit with any of these therapies may reasonably choose no systemic therapy.

For HCC patients with poor liver function, who are not eligible for LRT or resection, or with metastatic disease, the guidelines recommend against routine use of sorafenib.

In the setting of adjuvant therapy following curative surgical resection, curative local ablation, or TACE LRT, the guidelines recommend against the use of sorafenib. The authors also recommended against the use of bevacizumab following TACE LRT.

The authors noted that there is no high-quality comparative evidence in the second-line setting for atezolizumab plus bevacizumab, sorafenib, or lenvatinib. There is a dearth of evidence and few biomarkers to guide personalization of therapies, which places the emphasis on patient preferences, risks, and benefits.

The authors disclosed no conflicts.

New recommendations from the American Gastroenterological Association focus on choice of systemic therapy in hepatocellular carcinoma (HCC) patients. The guideline authors point out that prognosis and treatment decisions are both heavily dependent on a combination of the severity of underlying disease and biological characteristics of the tumor.

The document includes options for patients who are ineligible for locoregional therapy or resection, patients with metastatic disease and preserved liver function, patients with poor liver function, and patients receiving adjuvant therapy following surgery or locoregional therapy (LRT).

Intermediate or advanced tumor stage is common among HCC patients, and curative options such as surgery and ablation are generally limited to early-stage disease. LRTs – including transarterial chemoembolization (TACE), transarterial radioembolization (TARE), and systemic therapy – may be employed against advanced or metastatic HCC, according to the authors, led by Grace L. Su, MD, of the division of gastroenterology and hepatology at the University of Michigan, Ann Arbor, and the Veterans Affairs Ann Arbor Healthcare System.

In 2007, the Food and Drug Administration approved the multikinase inhibitor sorafenib as the first systemic therapy for HCC. The new guideline comes in the wake of new systemic therapeutic options that have arrived in the years since, including molecularly targeted therapy and immunotherapy. The authors of the guidance, published in Gastroenterology, include advice on both first- and second-line therapies.

Certainty of evidence for the recommendations ranges from low to very low, indicating limited or very little confidence in the effect estimated, and the true effect is likely to be considerably different than predicted by best current estimates. Accordingly, the recommendations are conditional, and decisions should be made with the values and preferences of the individual patient in mind.

In patients with preserved liver function who are ineligible for LRT or resection, or who have metastatic disease, the authors suggest that first-line treatment should be the combination of atezolizumab and bevacizumab rather than sorafenib. Bevacizumab comes with a bleeding risk, so patients should first be evaluated endoscopically and treated for esophageal varices. For patients who are ineligible for bevacizumab, alternatives are lenvatinib or sorafenib. Patients who are more concerned about disease progression than adverse events may want to consider lenvatinib rather than sorafenib, while those concerned about blood pressure control and who are less concerned about adverse skin reactions may choose sorafenib.

Options for second-line therapy after sorafenib include cabozantinib (mortality reduction, 2.2 months) and pembrolizumab (mortality reduction, 3.3 months). Patients with alpha-fetoprotein levels higher than 400 ng/mL may be candidates for treatment with ramucirumab (mortality reduction, 1.2 months). Another option is regorafenib (mortality reduction, 2.8 months). Patients who are more concerned about adverse effects than a potential survival benefit with any of these therapies may reasonably choose no systemic therapy.

For HCC patients with poor liver function, who are not eligible for LRT or resection, or with metastatic disease, the guidelines recommend against routine use of sorafenib.

In the setting of adjuvant therapy following curative surgical resection, curative local ablation, or TACE LRT, the guidelines recommend against the use of sorafenib. The authors also recommended against the use of bevacizumab following TACE LRT.

The authors noted that there is no high-quality comparative evidence in the second-line setting for atezolizumab plus bevacizumab, sorafenib, or lenvatinib. There is a dearth of evidence and few biomarkers to guide personalization of therapies, which places the emphasis on patient preferences, risks, and benefits.

The authors disclosed no conflicts.

PARIS – Following the suspension of the decree that banned the sale of cannabidiol (CBD) flowers, raw cannabis is again available in France for over-the-counter sales. The “feel-good” plant is praised for its relaxing properties.

Scott Harms/iStockphoto

The suspension of the ban, which lasted for 3 weeks, is a mixed blessing for businesses that sell CBD-based products in France. Professional organizations in this booming sector filed a petition with France’s highest administrative court, the Council of State. At the end of January, the court suspended the government decree that banned the sale of cannabis-derived CBD flowers and leaves; however, it has yet to hand down a final decision as to the legality of the decree.

In just a few years, numerous shops have opened across France. They no longer have to settle for selling processed CBD products such as chocolate, oils, cookies – even wine. They can resume the sale of CBD hemp, which mainly comes in clusters of flower buds and can be smoked or used as an infusion.

Cannabis-derived CBD must have less than 0.2% tetrahydrocannabinol (THC) to be considered “feel-good hemp,” which is used in various consumer goods (such as food, cosmetics, and e-cigarette liquids) and is praised for its calming effects. But not all hemp is the same. Medical hemp, which is currently in clinical trials, combines varying doses of CBD and THC. And then there is THC-rich psychotropic hemp, which is illegal to sell.

The government’s decree cites health concerns as a justification for the ban. While uncertainties remain, “research studies have shown that CBD acts on dopamine and serotonin receptors in the brain. ... Therefore, using CBD can produce psychoactive, sedative, and sleep-inducing effects.” In addition to a preventive approach, the authorities cite the difficulties in distinguishing cannabis-derived CBD from THC-rich illegal cannabis – difficulties that complicate efforts in the war on drugs.

The government’s position sows confusion among consumers, who are attracted by the arguments in favor of CBD and intrigued by the promise of the substance’s calming effects. This confusion is heightened by the fact that there are not enough scientific data either to declare that CBD poses a real risk or, alternatively, to confirm that it has beneficial effects. While some studies have suggested that CBD has a potential benefit for treating anxiety, pain, and sleep problems, others suggest that it may instead be a placebo effect.

What actual benefit can be expected from CBD-derived products, in particular from using the plant’s raw extracts? We asked Dan Velea, MD, an addiction psychiatrist in Paris, to give us his thoughts.

What do you think of the government’s position of banning the sale of cannabis-derived CBD flowers and leaves?

Dr. Velea: I don’t understand the reasoning behind this ban. Unlike THC, CBD is not an addictive substance. We’ve suspected that CBD had beneficial effects ever since noting that, just like THC, it could bind to the two types of cannabinoid receptors found in our bodies, CB1 and CB2, but without inducing a psychotropic effect or giving rise to dependence.

The CBD-derived products that are available on the market have infinitesimal amounts of THC – the threshold is 0.2% – which pose no risk. These products seem to be a particularly good alternative for certain at-risk users who are looking for a way that will help them cut down on their use of “traditional” cannabis, which has THC. However, due to a lack of research, the benefits of CBD cannot be confirmed.

Now that the decree’s been suspended, we can leave behind the ideological debate that has been built around cannabis in France. It’s time to focus only on discussions based on science. On that note, we also have to encourage people to do more research into cannabis’s therapeutic value.

You believe that CBD can help people cut down on their cannabis use. Is that based on what you see in your practice as an addiction specialist?

Dr. Velea: Some of my patients have been quite successful in cutting down on their cannabis use by switching to CBD. Knowing the risk and harm associated with the absorption of THC, they prefer to smoke CBD instead. Of course, they don’t get the same dazzling effect that’s produced by THC, very high concentrations of which are often found in cannabis. But for them, the sensation they get from CBD is still pleasant. They describe it as having a soothing and fun effect; they quite like it. Given that the vast majority of people use cannabis recreationally, we can consider that this effect is no small benefit.

Even those who are highly dependent prefer to alternate, using CBD during the day and having just one THC joint in the evening. This makes them feel a lot better. In addition, it clearly reduces the health risks. In my opinion, CBD can be viewed as an alternative for people whose cannabis use is problematic. If a patient asks me about it, I give them an unequivocal answer: There are fewer risks associated with CBD than with regular cannabis.

Isn’t there still a risk for abuse? A dose of cannabidiol that shouldn’t be exceeded?

Dr. Velea: Honestly, apart from the harmful effects of smoking CBD, I don’t see any health risks associated with its use. I’ve never had a patient present with complaints after using these products. No one has ever told me that they became addicted or experienced psychotropic effects. There are no changes in behavior, even at high doses. It should be mentioned that World Health Organization experts hold that there’s no abuse or dependence potential associated with the use of pure CBD. Furthermore, they say that the product is generally well tolerated.

What other actual benefits does CBD have? People mention its relaxing, even anxiolytic, effects.

Dr. Velea: CBD-derived products are praised for their relaxing properties, which particularly help improve one’s sleep. It’s a question of knowing whether these are actual benefits or whether a placebo effect is involved here – something that would be enhanced in a person who firmly believes that these products bring about a sense of well-being. Even when CBD is used for pain relief, we can’t rule out the placebo effect as playing an important role in the outcome.

Some patients with serious diseases have been able to find comfort by using CBD. However, because there haven’t been any well-designed randomized studies, we’ve never been able to show clearly that the beneficial effect comes from the product itself. It’s also possible that the soothing, muscle-relaxing effect induced by CBD’s stimulation of cannabinoid receptors is actually what’s helping to relieve the pain. But this has yet to be proved.

So, what position can a doctor take toward patients who express their desire to use CBD-derived products?

Dr. Velea: Without reliable studies to back them up, it’s difficult to say. Also, at the moment, there are legal gray areas that don’t allow doctors to take a position. As a result, users are put at a disadvantage and not given the opportunity to make the choice to use CBD-derived products in an informed manner. Even so, I think that as long as we don’t have scientific data, the use of these products must be limited to recreational use with the aim of bringing about relaxation. In the case of a sleep disorder, for example, doctors can’t replace standard therapeutic management aimed at improving the patient’s sleep cycles. For now, the only genuinely interesting aspect of CBD that I can see is that it makes it possible to cut down on the use of THC-containing cannabis.

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

PARIS – Following the suspension of the decree that banned the sale of cannabidiol (CBD) flowers, raw cannabis is again available in France for over-the-counter sales. The “feel-good” plant is praised for its relaxing properties.

Scott Harms/iStockphoto

The suspension of the ban, which lasted for 3 weeks, is a mixed blessing for businesses that sell CBD-based products in France. Professional organizations in this booming sector filed a petition with France’s highest administrative court, the Council of State. At the end of January, the court suspended the government decree that banned the sale of cannabis-derived CBD flowers and leaves; however, it has yet to hand down a final decision as to the legality of the decree.

In just a few years, numerous shops have opened across France. They no longer have to settle for selling processed CBD products such as chocolate, oils, cookies – even wine. They can resume the sale of CBD hemp, which mainly comes in clusters of flower buds and can be smoked or used as an infusion.

Cannabis-derived CBD must have less than 0.2% tetrahydrocannabinol (THC) to be considered “feel-good hemp,” which is used in various consumer goods (such as food, cosmetics, and e-cigarette liquids) and is praised for its calming effects. But not all hemp is the same. Medical hemp, which is currently in clinical trials, combines varying doses of CBD and THC. And then there is THC-rich psychotropic hemp, which is illegal to sell.

The government’s decree cites health concerns as a justification for the ban. While uncertainties remain, “research studies have shown that CBD acts on dopamine and serotonin receptors in the brain. ... Therefore, using CBD can produce psychoactive, sedative, and sleep-inducing effects.” In addition to a preventive approach, the authorities cite the difficulties in distinguishing cannabis-derived CBD from THC-rich illegal cannabis – difficulties that complicate efforts in the war on drugs.

The government’s position sows confusion among consumers, who are attracted by the arguments in favor of CBD and intrigued by the promise of the substance’s calming effects. This confusion is heightened by the fact that there are not enough scientific data either to declare that CBD poses a real risk or, alternatively, to confirm that it has beneficial effects. While some studies have suggested that CBD has a potential benefit for treating anxiety, pain, and sleep problems, others suggest that it may instead be a placebo effect.

What actual benefit can be expected from CBD-derived products, in particular from using the plant’s raw extracts? We asked Dan Velea, MD, an addiction psychiatrist in Paris, to give us his thoughts.

What do you think of the government’s position of banning the sale of cannabis-derived CBD flowers and leaves?

Dr. Velea: I don’t understand the reasoning behind this ban. Unlike THC, CBD is not an addictive substance. We’ve suspected that CBD had beneficial effects ever since noting that, just like THC, it could bind to the two types of cannabinoid receptors found in our bodies, CB1 and CB2, but without inducing a psychotropic effect or giving rise to dependence.

The CBD-derived products that are available on the market have infinitesimal amounts of THC – the threshold is 0.2% – which pose no risk. These products seem to be a particularly good alternative for certain at-risk users who are looking for a way that will help them cut down on their use of “traditional” cannabis, which has THC. However, due to a lack of research, the benefits of CBD cannot be confirmed.

Now that the decree’s been suspended, we can leave behind the ideological debate that has been built around cannabis in France. It’s time to focus only on discussions based on science. On that note, we also have to encourage people to do more research into cannabis’s therapeutic value.

You believe that CBD can help people cut down on their cannabis use. Is that based on what you see in your practice as an addiction specialist?

Dr. Velea: Some of my patients have been quite successful in cutting down on their cannabis use by switching to CBD. Knowing the risk and harm associated with the absorption of THC, they prefer to smoke CBD instead. Of course, they don’t get the same dazzling effect that’s produced by THC, very high concentrations of which are often found in cannabis. But for them, the sensation they get from CBD is still pleasant. They describe it as having a soothing and fun effect; they quite like it. Given that the vast majority of people use cannabis recreationally, we can consider that this effect is no small benefit.

Even those who are highly dependent prefer to alternate, using CBD during the day and having just one THC joint in the evening. This makes them feel a lot better. In addition, it clearly reduces the health risks. In my opinion, CBD can be viewed as an alternative for people whose cannabis use is problematic. If a patient asks me about it, I give them an unequivocal answer: There are fewer risks associated with CBD than with regular cannabis.

Isn’t there still a risk for abuse? A dose of cannabidiol that shouldn’t be exceeded?

Dr. Velea: Honestly, apart from the harmful effects of smoking CBD, I don’t see any health risks associated with its use. I’ve never had a patient present with complaints after using these products. No one has ever told me that they became addicted or experienced psychotropic effects. There are no changes in behavior, even at high doses. It should be mentioned that World Health Organization experts hold that there’s no abuse or dependence potential associated with the use of pure CBD. Furthermore, they say that the product is generally well tolerated.

What other actual benefits does CBD have? People mention its relaxing, even anxiolytic, effects.

Dr. Velea: CBD-derived products are praised for their relaxing properties, which particularly help improve one’s sleep. It’s a question of knowing whether these are actual benefits or whether a placebo effect is involved here – something that would be enhanced in a person who firmly believes that these products bring about a sense of well-being. Even when CBD is used for pain relief, we can’t rule out the placebo effect as playing an important role in the outcome.

Some patients with serious diseases have been able to find comfort by using CBD. However, because there haven’t been any well-designed randomized studies, we’ve never been able to show clearly that the beneficial effect comes from the product itself. It’s also possible that the soothing, muscle-relaxing effect induced by CBD’s stimulation of cannabinoid receptors is actually what’s helping to relieve the pain. But this has yet to be proved.

So, what position can a doctor take toward patients who express their desire to use CBD-derived products?

Dr. Velea: Without reliable studies to back them up, it’s difficult to say. Also, at the moment, there are legal gray areas that don’t allow doctors to take a position. As a result, users are put at a disadvantage and not given the opportunity to make the choice to use CBD-derived products in an informed manner. Even so, I think that as long as we don’t have scientific data, the use of these products must be limited to recreational use with the aim of bringing about relaxation. In the case of a sleep disorder, for example, doctors can’t replace standard therapeutic management aimed at improving the patient’s sleep cycles. For now, the only genuinely interesting aspect of CBD that I can see is that it makes it possible to cut down on the use of THC-containing cannabis.

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

PARIS – Following the suspension of the decree that banned the sale of cannabidiol (CBD) flowers, raw cannabis is again available in France for over-the-counter sales. The “feel-good” plant is praised for its relaxing properties.

Scott Harms/iStockphoto

The suspension of the ban, which lasted for 3 weeks, is a mixed blessing for businesses that sell CBD-based products in France. Professional organizations in this booming sector filed a petition with France’s highest administrative court, the Council of State. At the end of January, the court suspended the government decree that banned the sale of cannabis-derived CBD flowers and leaves; however, it has yet to hand down a final decision as to the legality of the decree.

In just a few years, numerous shops have opened across France. They no longer have to settle for selling processed CBD products such as chocolate, oils, cookies – even wine. They can resume the sale of CBD hemp, which mainly comes in clusters of flower buds and can be smoked or used as an infusion.

Cannabis-derived CBD must have less than 0.2% tetrahydrocannabinol (THC) to be considered “feel-good hemp,” which is used in various consumer goods (such as food, cosmetics, and e-cigarette liquids) and is praised for its calming effects. But not all hemp is the same. Medical hemp, which is currently in clinical trials, combines varying doses of CBD and THC. And then there is THC-rich psychotropic hemp, which is illegal to sell.

The government’s decree cites health concerns as a justification for the ban. While uncertainties remain, “research studies have shown that CBD acts on dopamine and serotonin receptors in the brain. ... Therefore, using CBD can produce psychoactive, sedative, and sleep-inducing effects.” In addition to a preventive approach, the authorities cite the difficulties in distinguishing cannabis-derived CBD from THC-rich illegal cannabis – difficulties that complicate efforts in the war on drugs.

The government’s position sows confusion among consumers, who are attracted by the arguments in favor of CBD and intrigued by the promise of the substance’s calming effects. This confusion is heightened by the fact that there are not enough scientific data either to declare that CBD poses a real risk or, alternatively, to confirm that it has beneficial effects. While some studies have suggested that CBD has a potential benefit for treating anxiety, pain, and sleep problems, others suggest that it may instead be a placebo effect.

What actual benefit can be expected from CBD-derived products, in particular from using the plant’s raw extracts? We asked Dan Velea, MD, an addiction psychiatrist in Paris, to give us his thoughts.

What do you think of the government’s position of banning the sale of cannabis-derived CBD flowers and leaves?

Dr. Velea: I don’t understand the reasoning behind this ban. Unlike THC, CBD is not an addictive substance. We’ve suspected that CBD had beneficial effects ever since noting that, just like THC, it could bind to the two types of cannabinoid receptors found in our bodies, CB1 and CB2, but without inducing a psychotropic effect or giving rise to dependence.

The CBD-derived products that are available on the market have infinitesimal amounts of THC – the threshold is 0.2% – which pose no risk. These products seem to be a particularly good alternative for certain at-risk users who are looking for a way that will help them cut down on their use of “traditional” cannabis, which has THC. However, due to a lack of research, the benefits of CBD cannot be confirmed.

Now that the decree’s been suspended, we can leave behind the ideological debate that has been built around cannabis in France. It’s time to focus only on discussions based on science. On that note, we also have to encourage people to do more research into cannabis’s therapeutic value.

You believe that CBD can help people cut down on their cannabis use. Is that based on what you see in your practice as an addiction specialist?

Dr. Velea: Some of my patients have been quite successful in cutting down on their cannabis use by switching to CBD. Knowing the risk and harm associated with the absorption of THC, they prefer to smoke CBD instead. Of course, they don’t get the same dazzling effect that’s produced by THC, very high concentrations of which are often found in cannabis. But for them, the sensation they get from CBD is still pleasant. They describe it as having a soothing and fun effect; they quite like it. Given that the vast majority of people use cannabis recreationally, we can consider that this effect is no small benefit.

Even those who are highly dependent prefer to alternate, using CBD during the day and having just one THC joint in the evening. This makes them feel a lot better. In addition, it clearly reduces the health risks. In my opinion, CBD can be viewed as an alternative for people whose cannabis use is problematic. If a patient asks me about it, I give them an unequivocal answer: There are fewer risks associated with CBD than with regular cannabis.

Isn’t there still a risk for abuse? A dose of cannabidiol that shouldn’t be exceeded?

Dr. Velea: Honestly, apart from the harmful effects of smoking CBD, I don’t see any health risks associated with its use. I’ve never had a patient present with complaints after using these products. No one has ever told me that they became addicted or experienced psychotropic effects. There are no changes in behavior, even at high doses. It should be mentioned that World Health Organization experts hold that there’s no abuse or dependence potential associated with the use of pure CBD. Furthermore, they say that the product is generally well tolerated.

What other actual benefits does CBD have? People mention its relaxing, even anxiolytic, effects.

Dr. Velea: CBD-derived products are praised for their relaxing properties, which particularly help improve one’s sleep. It’s a question of knowing whether these are actual benefits or whether a placebo effect is involved here – something that would be enhanced in a person who firmly believes that these products bring about a sense of well-being. Even when CBD is used for pain relief, we can’t rule out the placebo effect as playing an important role in the outcome.

Some patients with serious diseases have been able to find comfort by using CBD. However, because there haven’t been any well-designed randomized studies, we’ve never been able to show clearly that the beneficial effect comes from the product itself. It’s also possible that the soothing, muscle-relaxing effect induced by CBD’s stimulation of cannabinoid receptors is actually what’s helping to relieve the pain. But this has yet to be proved.

So, what position can a doctor take toward patients who express their desire to use CBD-derived products?

Dr. Velea: Without reliable studies to back them up, it’s difficult to say. Also, at the moment, there are legal gray areas that don’t allow doctors to take a position. As a result, users are put at a disadvantage and not given the opportunity to make the choice to use CBD-derived products in an informed manner. Even so, I think that as long as we don’t have scientific data, the use of these products must be limited to recreational use with the aim of bringing about relaxation. In the case of a sleep disorder, for example, doctors can’t replace standard therapeutic management aimed at improving the patient’s sleep cycles. For now, the only genuinely interesting aspect of CBD that I can see is that it makes it possible to cut down on the use of THC-containing cannabis.

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

A randomized, controlled trial of transcranial direct current stimulation (tDCS) in patients with multiple sclerosis (MS) showed improvement in a secondary outcome measure – cognition – and provided evidence that the technique can be employed outside of a physician’s office.

The primary outcome of the sham-controlled trial was fatigue, but the findings presented at the annual meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) focused on a secondary cognitive measure, called the Brief International Cognitive Assessment for MS (BICAMS).

The intervention may still be a work in progress as far as a treatment technique “but the more important point is that there is a path to remote cognitive rehab interventions which, as a concept, is important,” said Mark Gudesblatt, MD, medical director at South Shore Neurologic Associates in Patchogue, N.Y., who was asked to comment on the study.
 

Adaptive mechanisms

The study grew out of work done with BrainHQ, which is a brain-training program available commercially through Posit Science. It employs an algorithm to recommend and tailor exercises for participants and to adjust the difficulty of the exercises in order to maintain engagement. “We believe the key ingredient is really the adaptive mechanisms that adjust to users in real time, for instance slowing down when the user slows down or speeding up to drive the learning to maintain a level of engagement. The games are designed to target processing speed that then has a transfer effect to other aspects of cognitive function,” Leigh Charvet, PhD, said during her presentation of the study results. Dr. Charvet is director of MS research and a professor of neurology at New York University.

The researchers previously conducted a large trial in patients with MS and showed that the adaptive mechanism, used for 60 hours over 12 weeks, could improve cognitive functioning. “We had two learnings from that trial: One that the brain training in at least a very intense dose was beneficial for cognitive functioning, and the second was that at-home treatments are very popular,” said Dr. Charvet.

In the most recent trial, the researchers turned to tDCS in an effort to boost the effect of brain training. “The idea is that if you can stimulate the region of the brain that is engaged with the training activity, you can boost or potentiate the outcomes of the training,” said Dr. Charvet. The tDCS treatment applies 1.0-4.0 mA current to the scalp, where it can be placed to specifically affect a brain region of interest. The study targeted the dorsolateral prefrontal cortex, which is a key region for executive function and cognitive flexibility.

The team developed a protocol that would allow the intervention to be conducted at home, with live supervision via HIPAA-compliant teleconferencing and technology that was designed for ease of use. The tDCS devices were preprogrammed and operated on an unlock code, which initiated active or sham tDCS. “We replicated onsite lab standards, but delivered it to people at home,” said Dr. Charvet.

In the new study, 106 patients with MS who had fatigue, but not depression, underwent 30 20-minute training sessions over a 6-week period, with active or sham tDCS. The participants were tested before and after treatment using the BICAMS. The sham group had a mean change of –0.17 in the BICAMS z score, compared with a mean of +0.05 in the tDCS group (P = .027).

One of the tests that make up the BICAMS battery, the single digit modalities test (SDMT), showed a trend toward improvement in the tDCS group (z sore, +0.09 versus –0.19; P = .058). There was no significant difference between the groups In the Rey’s Auditory Verbal Learning Test or the Brief Visuospatial Memory Test–Revised.
 

What about fatigue?

The emphasis on a secondary outcome drew some criticism. “It’s odd, because the primary outcome was fatigue. They didn’t report the primary outcome, they focused on a secondary outcome of cognitive measure,” said Patricia Coyle, MD, who was asked to comment on the study.

“I think the most important finding in this study was that they were able to deliver the transcranial direct current stimulation at home, via computer. They were able to do this study by computer with their patients at home, and it was a fairly large number. You could consider it broadly as a proof of principle that this can be done,” said Dr. Coyle, professor of neurology and director of Stony Brook MS Comprehensive Care Center.

The study was funded by the National MS Society. Dr. Gudesblatt has no relevant financial disclosures. Dr. Coyle has consulted or received speaker fees from Accord-ant, Alexion, Biogen, Bristol Myers Squibb, Celgene, GlaxoSmithKline, Horizon Therapeutics, Janssen, Mylan, Novartis, Sanofi Genzyme, TG Therapeutics, and Viela Bio. Dr. Coyle has received research funding from Actelion, Alker-mes, Celgene, CorEvitas LLC, Genentech/Roche, MedDay, Novartis, and Sanofi Genzyme.

A randomized, controlled trial of transcranial direct current stimulation (tDCS) in patients with multiple sclerosis (MS) showed improvement in a secondary outcome measure – cognition – and provided evidence that the technique can be employed outside of a physician’s office.

The primary outcome of the sham-controlled trial was fatigue, but the findings presented at the annual meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) focused on a secondary cognitive measure, called the Brief International Cognitive Assessment for MS (BICAMS).

The intervention may still be a work in progress as far as a treatment technique “but the more important point is that there is a path to remote cognitive rehab interventions which, as a concept, is important,” said Mark Gudesblatt, MD, medical director at South Shore Neurologic Associates in Patchogue, N.Y., who was asked to comment on the study.
 

Adaptive mechanisms

The study grew out of work done with BrainHQ, which is a brain-training program available commercially through Posit Science. It employs an algorithm to recommend and tailor exercises for participants and to adjust the difficulty of the exercises in order to maintain engagement. “We believe the key ingredient is really the adaptive mechanisms that adjust to users in real time, for instance slowing down when the user slows down or speeding up to drive the learning to maintain a level of engagement. The games are designed to target processing speed that then has a transfer effect to other aspects of cognitive function,” Leigh Charvet, PhD, said during her presentation of the study results. Dr. Charvet is director of MS research and a professor of neurology at New York University.

The researchers previously conducted a large trial in patients with MS and showed that the adaptive mechanism, used for 60 hours over 12 weeks, could improve cognitive functioning. “We had two learnings from that trial: One that the brain training in at least a very intense dose was beneficial for cognitive functioning, and the second was that at-home treatments are very popular,” said Dr. Charvet.

In the most recent trial, the researchers turned to tDCS in an effort to boost the effect of brain training. “The idea is that if you can stimulate the region of the brain that is engaged with the training activity, you can boost or potentiate the outcomes of the training,” said Dr. Charvet. The tDCS treatment applies 1.0-4.0 mA current to the scalp, where it can be placed to specifically affect a brain region of interest. The study targeted the dorsolateral prefrontal cortex, which is a key region for executive function and cognitive flexibility.

The team developed a protocol that would allow the intervention to be conducted at home, with live supervision via HIPAA-compliant teleconferencing and technology that was designed for ease of use. The tDCS devices were preprogrammed and operated on an unlock code, which initiated active or sham tDCS. “We replicated onsite lab standards, but delivered it to people at home,” said Dr. Charvet.

In the new study, 106 patients with MS who had fatigue, but not depression, underwent 30 20-minute training sessions over a 6-week period, with active or sham tDCS. The participants were tested before and after treatment using the BICAMS. The sham group had a mean change of –0.17 in the BICAMS z score, compared with a mean of +0.05 in the tDCS group (P = .027).

One of the tests that make up the BICAMS battery, the single digit modalities test (SDMT), showed a trend toward improvement in the tDCS group (z sore, +0.09 versus –0.19; P = .058). There was no significant difference between the groups In the Rey’s Auditory Verbal Learning Test or the Brief Visuospatial Memory Test–Revised.
 

What about fatigue?

The emphasis on a secondary outcome drew some criticism. “It’s odd, because the primary outcome was fatigue. They didn’t report the primary outcome, they focused on a secondary outcome of cognitive measure,” said Patricia Coyle, MD, who was asked to comment on the study.

“I think the most important finding in this study was that they were able to deliver the transcranial direct current stimulation at home, via computer. They were able to do this study by computer with their patients at home, and it was a fairly large number. You could consider it broadly as a proof of principle that this can be done,” said Dr. Coyle, professor of neurology and director of Stony Brook MS Comprehensive Care Center.

The study was funded by the National MS Society. Dr. Gudesblatt has no relevant financial disclosures. Dr. Coyle has consulted or received speaker fees from Accord-ant, Alexion, Biogen, Bristol Myers Squibb, Celgene, GlaxoSmithKline, Horizon Therapeutics, Janssen, Mylan, Novartis, Sanofi Genzyme, TG Therapeutics, and Viela Bio. Dr. Coyle has received research funding from Actelion, Alker-mes, Celgene, CorEvitas LLC, Genentech/Roche, MedDay, Novartis, and Sanofi Genzyme.

A randomized, controlled trial of transcranial direct current stimulation (tDCS) in patients with multiple sclerosis (MS) showed improvement in a secondary outcome measure – cognition – and provided evidence that the technique can be employed outside of a physician’s office.

The primary outcome of the sham-controlled trial was fatigue, but the findings presented at the annual meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) focused on a secondary cognitive measure, called the Brief International Cognitive Assessment for MS (BICAMS).

The intervention may still be a work in progress as far as a treatment technique “but the more important point is that there is a path to remote cognitive rehab interventions which, as a concept, is important,” said Mark Gudesblatt, MD, medical director at South Shore Neurologic Associates in Patchogue, N.Y., who was asked to comment on the study.
 

Adaptive mechanisms

The study grew out of work done with BrainHQ, which is a brain-training program available commercially through Posit Science. It employs an algorithm to recommend and tailor exercises for participants and to adjust the difficulty of the exercises in order to maintain engagement. “We believe the key ingredient is really the adaptive mechanisms that adjust to users in real time, for instance slowing down when the user slows down or speeding up to drive the learning to maintain a level of engagement. The games are designed to target processing speed that then has a transfer effect to other aspects of cognitive function,” Leigh Charvet, PhD, said during her presentation of the study results. Dr. Charvet is director of MS research and a professor of neurology at New York University.

The researchers previously conducted a large trial in patients with MS and showed that the adaptive mechanism, used for 60 hours over 12 weeks, could improve cognitive functioning. “We had two learnings from that trial: One that the brain training in at least a very intense dose was beneficial for cognitive functioning, and the second was that at-home treatments are very popular,” said Dr. Charvet.

In the most recent trial, the researchers turned to tDCS in an effort to boost the effect of brain training. “The idea is that if you can stimulate the region of the brain that is engaged with the training activity, you can boost or potentiate the outcomes of the training,” said Dr. Charvet. The tDCS treatment applies 1.0-4.0 mA current to the scalp, where it can be placed to specifically affect a brain region of interest. The study targeted the dorsolateral prefrontal cortex, which is a key region for executive function and cognitive flexibility.

The team developed a protocol that would allow the intervention to be conducted at home, with live supervision via HIPAA-compliant teleconferencing and technology that was designed for ease of use. The tDCS devices were preprogrammed and operated on an unlock code, which initiated active or sham tDCS. “We replicated onsite lab standards, but delivered it to people at home,” said Dr. Charvet.

In the new study, 106 patients with MS who had fatigue, but not depression, underwent 30 20-minute training sessions over a 6-week period, with active or sham tDCS. The participants were tested before and after treatment using the BICAMS. The sham group had a mean change of –0.17 in the BICAMS z score, compared with a mean of +0.05 in the tDCS group (P = .027).

One of the tests that make up the BICAMS battery, the single digit modalities test (SDMT), showed a trend toward improvement in the tDCS group (z sore, +0.09 versus –0.19; P = .058). There was no significant difference between the groups In the Rey’s Auditory Verbal Learning Test or the Brief Visuospatial Memory Test–Revised.
 

What about fatigue?

The emphasis on a secondary outcome drew some criticism. “It’s odd, because the primary outcome was fatigue. They didn’t report the primary outcome, they focused on a secondary outcome of cognitive measure,” said Patricia Coyle, MD, who was asked to comment on the study.

“I think the most important finding in this study was that they were able to deliver the transcranial direct current stimulation at home, via computer. They were able to do this study by computer with their patients at home, and it was a fairly large number. You could consider it broadly as a proof of principle that this can be done,” said Dr. Coyle, professor of neurology and director of Stony Brook MS Comprehensive Care Center.

The study was funded by the National MS Society. Dr. Gudesblatt has no relevant financial disclosures. Dr. Coyle has consulted or received speaker fees from Accord-ant, Alexion, Biogen, Bristol Myers Squibb, Celgene, GlaxoSmithKline, Horizon Therapeutics, Janssen, Mylan, Novartis, Sanofi Genzyme, TG Therapeutics, and Viela Bio. Dr. Coyle has received research funding from Actelion, Alker-mes, Celgene, CorEvitas LLC, Genentech/Roche, MedDay, Novartis, and Sanofi Genzyme.

WEST PALM BEACH, FLA. – Women with multiple sclerosis (MS) undergoing assisted reproductive technologies (ART) have an increased relapse risk if they are not treated with disease-modifying therapy (DMT), new research suggests. In a cohort study of women undergoing ART, those who did not receive DMTs had a significantly higher relapse risk than their peers who were treated with the drugs.

In addition, the likelihood of achieving pregnancy through ART while having MS appeared favorable, researchers noted.

“In this modern case series and the largest cohort to date, we identified a lower risk of relapses after ART than previously reported,” Edith L. Graham, MD, of the department of neurology, Northwestern University, Chicago, and colleagues  wrote. “Importantly, continuing DMT during ART may reduce risk of relapse during this period of marked hormonal fluctuations and stressors,” they added.

The findings were presented at the annual meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis.
 

Study details

Previous research shows a wide range of relapse risk in patients with MS undergoing ART.

To investigate the potential role of DMTs in mitigating relapse risk, the researchers evaluated data on 37 women with either relapsing-remitting MS (n = 31) or clinically isolated syndrome (CIS; n = 6) who underwent ART. The women all had low disability, with a median Expanded Disability Status Scale (EDSS) score of 1.0. All participants had undergone one to five cycles of reproductive therapy between 2010 and 2021.

Most (78%) were receiving ART because of infertility or a need for preimplantation genetic testing, whereas 22% were undergoing the treatment for the preservation of fertility. Average age of the participants was 35 years and average disease duration was 7.4 years.

Among 19 of the 37 patients who were taking DMTs prior to ART, 10 remained on the medication throughout ovarian hyperstimulation.

In those who received DMTs in the 12 months prior to ART, treatment included glatiramer acetate (n = 9), interferons (n = 3), and dimethyl fumarate (n = 1). Three participants received B-cell–depleting agents.

In addition, three women received medication in response to a rebound after discontinuation. Of these, two received fingolimod and one natalizumab.

Five patients (13.5%) experienced MS relapses in the 12 months following ART therapy. Among those experiencing relapse, none were treated with DMTs during the preceding 12 months.

Of the relapses, three occurred within 3 months of the ART treatment, one within 6 months, and one within 12 months.
 

High rate of successful pregnancy

Overall, 24 of 29 women (83%) underwent in vitro fertilization (IVF) with embryo transfer as part of ART achieved pregnancy. The remaining five patients were undergoing egg cryopreservation.

Although 14 of the 24 who achieved pregnancy were on DMTs and 2 of 5 who did not achieve pregnancy were on the therapies, Dr. Graham noted, “these numbers seem too small to draw conclusions.”

In particular, patients may benefit from treatment with rituximab or ocrelizumab 3-6 months prior to ART, “which gives better protection during ART cycle with low risk of fetal exposure,” she said.

“Treatment does not need to be discontinued if undergoing embryo banking only,” Dr. Graham added. “The risk to the fetus occurs only after embryo transfer.”

Although there is a lack of research examining whether MS relapse lowers the chance of pregnancy, Dr. Graham noted, “in theory, relapsing MS may compromise ART success because [patients] may have a narrower window to undergo ART treatments if they are trying to mitigate DMT exposure to the fetus.” 

However, the study’s results generally suggest favorable outcomes with ART among women with MS, she added. “We found that overall ART is actually very successful among people with MS. I was actually very surprised by this high rate of successful pregnancy,” Dr. Graham said.

She noted that as women with MS increasingly undergo IVF as well as egg cryopreservation, research on these issues is gaining importance for clinicians. “This is going to be something that MS specialists need to know more about, particularly the safety of ART in their patients,” said Dr. Graham.

“What’s important is there are no [formal] recommendations along these lines, so this represents an opportunity to get the word out to clinicians that you want to make sure patients with MS are protected throughout the ART cycle and that you’re not discontinuing their DMT too early,” she added.
 

Protective against relapse?

Commenting on the study, Jiwon Oh, MD, PhD, medical director of the Barlo Multiple Sclerosis Program at St. Michael’s Hospital, University of Toronto, noted that, while there are many guidelines/recommendations regarding use of older DMTs peripregnancy, data on many newer therapies is more limited.

“Often, when people do not have definitive evidence, they tend to take a conservative approach, which is why there is likely reluctance to keep patients on DMTs during ART as well as in early pregnancy,” said Dr. Oh, who was not involved in the research.

Importantly, there is also no definitive evidence of a relationship between MS relapses and ART success or pregnancy outcomes, she noted. However, “from a common-sense perspective, most clinicians worry that extreme stress or disability may negatively affect both ART and pregnancy outcomes,” she added.

Dr. Oh agreed that ocrelizumab is an appropriate choice in terms of preventing relapse during ART. “Ocrevus is one of our highest-efficacy DMTs and is only dosed every 6 months. So this allows for ART cycles and conception without worrying about fetal drug exposure and the drug affecting ART cycles,” she said.

She noted the study’s findings “are in keeping with some prior studies, but not others, demonstrating there may be a higher risk of relapse with ART” in patients who are not taking a DMT.

“However, in my mind the most important conclusion from this study is that being on a DMT seems to be protective of relapse risk, which is an important point that will be useful to provide patients with clinical guidance,” Dr. Oh said.

Dr. Graham reported having received consulting fees from Genentech. Dr. Oh reported having received consulting or speaking fees from Alexion, Biogen Idec, BMS, EMD Serono, Genzyme, Novartis, and Roche.

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

WEST PALM BEACH, FLA. – Women with multiple sclerosis (MS) undergoing assisted reproductive technologies (ART) have an increased relapse risk if they are not treated with disease-modifying therapy (DMT), new research suggests. In a cohort study of women undergoing ART, those who did not receive DMTs had a significantly higher relapse risk than their peers who were treated with the drugs.

In addition, the likelihood of achieving pregnancy through ART while having MS appeared favorable, researchers noted.

“In this modern case series and the largest cohort to date, we identified a lower risk of relapses after ART than previously reported,” Edith L. Graham, MD, of the department of neurology, Northwestern University, Chicago, and colleagues  wrote. “Importantly, continuing DMT during ART may reduce risk of relapse during this period of marked hormonal fluctuations and stressors,” they added.

The findings were presented at the annual meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis.
 

Study details

Previous research shows a wide range of relapse risk in patients with MS undergoing ART.

To investigate the potential role of DMTs in mitigating relapse risk, the researchers evaluated data on 37 women with either relapsing-remitting MS (n = 31) or clinically isolated syndrome (CIS; n = 6) who underwent ART. The women all had low disability, with a median Expanded Disability Status Scale (EDSS) score of 1.0. All participants had undergone one to five cycles of reproductive therapy between 2010 and 2021.

Most (78%) were receiving ART because of infertility or a need for preimplantation genetic testing, whereas 22% were undergoing the treatment for the preservation of fertility. Average age of the participants was 35 years and average disease duration was 7.4 years.

Among 19 of the 37 patients who were taking DMTs prior to ART, 10 remained on the medication throughout ovarian hyperstimulation.

In those who received DMTs in the 12 months prior to ART, treatment included glatiramer acetate (n = 9), interferons (n = 3), and dimethyl fumarate (n = 1). Three participants received B-cell–depleting agents.

In addition, three women received medication in response to a rebound after discontinuation. Of these, two received fingolimod and one natalizumab.

Five patients (13.5%) experienced MS relapses in the 12 months following ART therapy. Among those experiencing relapse, none were treated with DMTs during the preceding 12 months.

Of the relapses, three occurred within 3 months of the ART treatment, one within 6 months, and one within 12 months.
 

High rate of successful pregnancy

Overall, 24 of 29 women (83%) underwent in vitro fertilization (IVF) with embryo transfer as part of ART achieved pregnancy. The remaining five patients were undergoing egg cryopreservation.

Although 14 of the 24 who achieved pregnancy were on DMTs and 2 of 5 who did not achieve pregnancy were on the therapies, Dr. Graham noted, “these numbers seem too small to draw conclusions.”

In particular, patients may benefit from treatment with rituximab or ocrelizumab 3-6 months prior to ART, “which gives better protection during ART cycle with low risk of fetal exposure,” she said.

“Treatment does not need to be discontinued if undergoing embryo banking only,” Dr. Graham added. “The risk to the fetus occurs only after embryo transfer.”

Although there is a lack of research examining whether MS relapse lowers the chance of pregnancy, Dr. Graham noted, “in theory, relapsing MS may compromise ART success because [patients] may have a narrower window to undergo ART treatments if they are trying to mitigate DMT exposure to the fetus.” 

However, the study’s results generally suggest favorable outcomes with ART among women with MS, she added. “We found that overall ART is actually very successful among people with MS. I was actually very surprised by this high rate of successful pregnancy,” Dr. Graham said.

She noted that as women with MS increasingly undergo IVF as well as egg cryopreservation, research on these issues is gaining importance for clinicians. “This is going to be something that MS specialists need to know more about, particularly the safety of ART in their patients,” said Dr. Graham.

“What’s important is there are no [formal] recommendations along these lines, so this represents an opportunity to get the word out to clinicians that you want to make sure patients with MS are protected throughout the ART cycle and that you’re not discontinuing their DMT too early,” she added.
 

Protective against relapse?

Commenting on the study, Jiwon Oh, MD, PhD, medical director of the Barlo Multiple Sclerosis Program at St. Michael’s Hospital, University of Toronto, noted that, while there are many guidelines/recommendations regarding use of older DMTs peripregnancy, data on many newer therapies is more limited.

“Often, when people do not have definitive evidence, they tend to take a conservative approach, which is why there is likely reluctance to keep patients on DMTs during ART as well as in early pregnancy,” said Dr. Oh, who was not involved in the research.

Importantly, there is also no definitive evidence of a relationship between MS relapses and ART success or pregnancy outcomes, she noted. However, “from a common-sense perspective, most clinicians worry that extreme stress or disability may negatively affect both ART and pregnancy outcomes,” she added.

Dr. Oh agreed that ocrelizumab is an appropriate choice in terms of preventing relapse during ART. “Ocrevus is one of our highest-efficacy DMTs and is only dosed every 6 months. So this allows for ART cycles and conception without worrying about fetal drug exposure and the drug affecting ART cycles,” she said.

She noted the study’s findings “are in keeping with some prior studies, but not others, demonstrating there may be a higher risk of relapse with ART” in patients who are not taking a DMT.

“However, in my mind the most important conclusion from this study is that being on a DMT seems to be protective of relapse risk, which is an important point that will be useful to provide patients with clinical guidance,” Dr. Oh said.

Dr. Graham reported having received consulting fees from Genentech. Dr. Oh reported having received consulting or speaking fees from Alexion, Biogen Idec, BMS, EMD Serono, Genzyme, Novartis, and Roche.

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

WEST PALM BEACH, FLA. – Women with multiple sclerosis (MS) undergoing assisted reproductive technologies (ART) have an increased relapse risk if they are not treated with disease-modifying therapy (DMT), new research suggests. In a cohort study of women undergoing ART, those who did not receive DMTs had a significantly higher relapse risk than their peers who were treated with the drugs.

In addition, the likelihood of achieving pregnancy through ART while having MS appeared favorable, researchers noted.

“In this modern case series and the largest cohort to date, we identified a lower risk of relapses after ART than previously reported,” Edith L. Graham, MD, of the department of neurology, Northwestern University, Chicago, and colleagues  wrote. “Importantly, continuing DMT during ART may reduce risk of relapse during this period of marked hormonal fluctuations and stressors,” they added.

The findings were presented at the annual meeting held by the Americas Committee for Treatment and Research in Multiple Sclerosis.
 

Study details

Previous research shows a wide range of relapse risk in patients with MS undergoing ART.

To investigate the potential role of DMTs in mitigating relapse risk, the researchers evaluated data on 37 women with either relapsing-remitting MS (n = 31) or clinically isolated syndrome (CIS; n = 6) who underwent ART. The women all had low disability, with a median Expanded Disability Status Scale (EDSS) score of 1.0. All participants had undergone one to five cycles of reproductive therapy between 2010 and 2021.

Most (78%) were receiving ART because of infertility or a need for preimplantation genetic testing, whereas 22% were undergoing the treatment for the preservation of fertility. Average age of the participants was 35 years and average disease duration was 7.4 years.

Among 19 of the 37 patients who were taking DMTs prior to ART, 10 remained on the medication throughout ovarian hyperstimulation.

In those who received DMTs in the 12 months prior to ART, treatment included glatiramer acetate (n = 9), interferons (n = 3), and dimethyl fumarate (n = 1). Three participants received B-cell–depleting agents.

In addition, three women received medication in response to a rebound after discontinuation. Of these, two received fingolimod and one natalizumab.

Five patients (13.5%) experienced MS relapses in the 12 months following ART therapy. Among those experiencing relapse, none were treated with DMTs during the preceding 12 months.

Of the relapses, three occurred within 3 months of the ART treatment, one within 6 months, and one within 12 months.
 

High rate of successful pregnancy

Overall, 24 of 29 women (83%) underwent in vitro fertilization (IVF) with embryo transfer as part of ART achieved pregnancy. The remaining five patients were undergoing egg cryopreservation.

Although 14 of the 24 who achieved pregnancy were on DMTs and 2 of 5 who did not achieve pregnancy were on the therapies, Dr. Graham noted, “these numbers seem too small to draw conclusions.”

In particular, patients may benefit from treatment with rituximab or ocrelizumab 3-6 months prior to ART, “which gives better protection during ART cycle with low risk of fetal exposure,” she said.

“Treatment does not need to be discontinued if undergoing embryo banking only,” Dr. Graham added. “The risk to the fetus occurs only after embryo transfer.”

Although there is a lack of research examining whether MS relapse lowers the chance of pregnancy, Dr. Graham noted, “in theory, relapsing MS may compromise ART success because [patients] may have a narrower window to undergo ART treatments if they are trying to mitigate DMT exposure to the fetus.” 

However, the study’s results generally suggest favorable outcomes with ART among women with MS, she added. “We found that overall ART is actually very successful among people with MS. I was actually very surprised by this high rate of successful pregnancy,” Dr. Graham said.

She noted that as women with MS increasingly undergo IVF as well as egg cryopreservation, research on these issues is gaining importance for clinicians. “This is going to be something that MS specialists need to know more about, particularly the safety of ART in their patients,” said Dr. Graham.

“What’s important is there are no [formal] recommendations along these lines, so this represents an opportunity to get the word out to clinicians that you want to make sure patients with MS are protected throughout the ART cycle and that you’re not discontinuing their DMT too early,” she added.
 

Protective against relapse?

Commenting on the study, Jiwon Oh, MD, PhD, medical director of the Barlo Multiple Sclerosis Program at St. Michael’s Hospital, University of Toronto, noted that, while there are many guidelines/recommendations regarding use of older DMTs peripregnancy, data on many newer therapies is more limited.

“Often, when people do not have definitive evidence, they tend to take a conservative approach, which is why there is likely reluctance to keep patients on DMTs during ART as well as in early pregnancy,” said Dr. Oh, who was not involved in the research.

Importantly, there is also no definitive evidence of a relationship between MS relapses and ART success or pregnancy outcomes, she noted. However, “from a common-sense perspective, most clinicians worry that extreme stress or disability may negatively affect both ART and pregnancy outcomes,” she added.

Dr. Oh agreed that ocrelizumab is an appropriate choice in terms of preventing relapse during ART. “Ocrevus is one of our highest-efficacy DMTs and is only dosed every 6 months. So this allows for ART cycles and conception without worrying about fetal drug exposure and the drug affecting ART cycles,” she said.

She noted the study’s findings “are in keeping with some prior studies, but not others, demonstrating there may be a higher risk of relapse with ART” in patients who are not taking a DMT.

“However, in my mind the most important conclusion from this study is that being on a DMT seems to be protective of relapse risk, which is an important point that will be useful to provide patients with clinical guidance,” Dr. Oh said.

Dr. Graham reported having received consulting fees from Genentech. Dr. Oh reported having received consulting or speaking fees from Alexion, Biogen Idec, BMS, EMD Serono, Genzyme, Novartis, and Roche.

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

The American Medical Association (AMA) honored CHEST Board Member Victor J. Test, MD, FCCP, with the AMA Medal of Valor for his work on behalf of patients and his community during the COVID-19 pandemic.

The American Medical Association (AMA) honored CHEST Board Member Victor J. Test, MD, FCCP, with the AMA Medal of Valor for his work on behalf of patients and his community during the COVID-19 pandemic.

The American Medical Association (AMA) honored CHEST Board Member Victor J. Test, MD, FCCP, with the AMA Medal of Valor for his work on behalf of patients and his community during the COVID-19 pandemic.

The CHEST Foundation cordially invites CHEST members and colleagues, health care professionals, and others to champion lung health and attend the annual Belmont Stakes Dinner and Auction, Saturday, June 11, in New York at the beautiful Water Club overlooking the East River.

Courtesy ACCP

Courtesy ACCP

The CHEST Foundation cordially invites CHEST members and colleagues, health care professionals, and others to champion lung health and attend the annual Belmont Stakes Dinner and Auction, Saturday, June 11, in New York at the beautiful Water Club overlooking the East River.

Courtesy ACCP

Courtesy ACCP

The CHEST Foundation cordially invites CHEST members and colleagues, health care professionals, and others to champion lung health and attend the annual Belmont Stakes Dinner and Auction, Saturday, June 11, in New York at the beautiful Water Club overlooking the East River.

Courtesy ACCP

Courtesy ACCP

Addressing disparities of socioeconomic status, race, and education in vaccine hesitancy and uptake

Vaccine hesitancy is described by the World Health Organization (WHO) as a “delay in acceptance or refusal of vaccination, despite availability of vaccine services.”¹ Disparities in COVID-19 vaccine uptake, in addition to preexisting views of vaccine hesitancy, are consistently in the mainstream news.

The United States has a high rate of vaccine hesitancy, with a third of the country surveyed in 2021 stating they were unlikely to become vaccinated against COVID-19.² This is in contrast to over 90% of people in Australia, China, and Norway saying they were highly likely to become vaccinated. Prepandemic, however, vaccination rates for preventable respiratory illness were already suboptimal. In fact, in 2019, the WHO declared vaccine hesitancy a top 10 priority due to the threat low vaccination causes on a global level.¹

U.S. health care systems’ cost to patients may serve as a disincentive for health care utilization, decreasing health care contacts. Further, changes in insurance can lead to provider discontinuity, which may erode the trusted patient-physician relationship. These realities may contribute to vaccine hesitancy that has been inversely correlated to both number of health care visits and trust in health care providers. Vaccine hesitancy exacerbates health disparities.¹ Health literacy (understanding of health), education level, and general vaccine knowledge contribute to vaccine hesitancy also. Additionally, high social vulnerability (a score calculated from factors related to socioeconomic status, race, household makeup, housing type, and transportation) is strongly inversely correlated with vaccination rates. In places with both high social vulnerability and vaccine hesitancy, the vaccine-hesitant individuals have far fewer vaccinations.³

Providers can impact vaccine uptake. Broadly, efforts to understand and address issues of trust in health care are needed. Educational materials should be disseminated to high-risk and medically underserved communities. At medical appointments, assessment of vaccination status, followed by providing individualized information regarding vaccine benefits and specific concerns may help increase uptake. In a survey of high-risk adults, only 14.8 and 18.5% of patients stated that the pneumococcal vaccine was offered to them in the last year and 5 years, respectively.¹ Providers can have a strong impact on people obtaining vaccines; over half of patients receive vaccines when their provider recommends it.^1,4 As a medical community focused on respiratory health, we need to prioritize offering vaccinations during inpatient and outpatient encounters.

By Jamie R. Felzer, MD, MPH

Network Member

Cassie C. Kennedy, MD, FCCP

Vice Chair, Council of Networks

Dr. Felzer is a Fellow and Dr. Kennedy is Associate Professor of Medicine, Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN.

References

1. Gatwood J et al. Am J Health Promot. 2021;35:908.

2. Wong LP et al. Infect Dis Poverty. 2021;10:122.

3. Crane MA et al. Health Aff (Millwood). 2021;40:1792.

4. Strully KW et al. Front Public Health. 2021;9:645268.

Addressing disparities of socioeconomic status, race, and education in vaccine hesitancy and uptake

Vaccine hesitancy is described by the World Health Organization (WHO) as a “delay in acceptance or refusal of vaccination, despite availability of vaccine services.”¹ Disparities in COVID-19 vaccine uptake, in addition to preexisting views of vaccine hesitancy, are consistently in the mainstream news.

The United States has a high rate of vaccine hesitancy, with a third of the country surveyed in 2021 stating they were unlikely to become vaccinated against COVID-19.² This is in contrast to over 90% of people in Australia, China, and Norway saying they were highly likely to become vaccinated. Prepandemic, however, vaccination rates for preventable respiratory illness were already suboptimal. In fact, in 2019, the WHO declared vaccine hesitancy a top 10 priority due to the threat low vaccination causes on a global level.¹

U.S. health care systems’ cost to patients may serve as a disincentive for health care utilization, decreasing health care contacts. Further, changes in insurance can lead to provider discontinuity, which may erode the trusted patient-physician relationship. These realities may contribute to vaccine hesitancy that has been inversely correlated to both number of health care visits and trust in health care providers. Vaccine hesitancy exacerbates health disparities.¹ Health literacy (understanding of health), education level, and general vaccine knowledge contribute to vaccine hesitancy also. Additionally, high social vulnerability (a score calculated from factors related to socioeconomic status, race, household makeup, housing type, and transportation) is strongly inversely correlated with vaccination rates. In places with both high social vulnerability and vaccine hesitancy, the vaccine-hesitant individuals have far fewer vaccinations.³

Providers can impact vaccine uptake. Broadly, efforts to understand and address issues of trust in health care are needed. Educational materials should be disseminated to high-risk and medically underserved communities. At medical appointments, assessment of vaccination status, followed by providing individualized information regarding vaccine benefits and specific concerns may help increase uptake. In a survey of high-risk adults, only 14.8 and 18.5% of patients stated that the pneumococcal vaccine was offered to them in the last year and 5 years, respectively.¹ Providers can have a strong impact on people obtaining vaccines; over half of patients receive vaccines when their provider recommends it.^1,4 As a medical community focused on respiratory health, we need to prioritize offering vaccinations during inpatient and outpatient encounters.

By Jamie R. Felzer, MD, MPH

Network Member

Cassie C. Kennedy, MD, FCCP

Vice Chair, Council of Networks

Dr. Felzer is a Fellow and Dr. Kennedy is Associate Professor of Medicine, Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN.

References

1. Gatwood J et al. Am J Health Promot. 2021;35:908.

2. Wong LP et al. Infect Dis Poverty. 2021;10:122.

3. Crane MA et al. Health Aff (Millwood). 2021;40:1792.

4. Strully KW et al. Front Public Health. 2021;9:645268.

Addressing disparities of socioeconomic status, race, and education in vaccine hesitancy and uptake

Vaccine hesitancy is described by the World Health Organization (WHO) as a “delay in acceptance or refusal of vaccination, despite availability of vaccine services.”¹ Disparities in COVID-19 vaccine uptake, in addition to preexisting views of vaccine hesitancy, are consistently in the mainstream news.

The United States has a high rate of vaccine hesitancy, with a third of the country surveyed in 2021 stating they were unlikely to become vaccinated against COVID-19.² This is in contrast to over 90% of people in Australia, China, and Norway saying they were highly likely to become vaccinated. Prepandemic, however, vaccination rates for preventable respiratory illness were already suboptimal. In fact, in 2019, the WHO declared vaccine hesitancy a top 10 priority due to the threat low vaccination causes on a global level.¹

U.S. health care systems’ cost to patients may serve as a disincentive for health care utilization, decreasing health care contacts. Further, changes in insurance can lead to provider discontinuity, which may erode the trusted patient-physician relationship. These realities may contribute to vaccine hesitancy that has been inversely correlated to both number of health care visits and trust in health care providers. Vaccine hesitancy exacerbates health disparities.¹ Health literacy (understanding of health), education level, and general vaccine knowledge contribute to vaccine hesitancy also. Additionally, high social vulnerability (a score calculated from factors related to socioeconomic status, race, household makeup, housing type, and transportation) is strongly inversely correlated with vaccination rates. In places with both high social vulnerability and vaccine hesitancy, the vaccine-hesitant individuals have far fewer vaccinations.³

Providers can impact vaccine uptake. Broadly, efforts to understand and address issues of trust in health care are needed. Educational materials should be disseminated to high-risk and medically underserved communities. At medical appointments, assessment of vaccination status, followed by providing individualized information regarding vaccine benefits and specific concerns may help increase uptake. In a survey of high-risk adults, only 14.8 and 18.5% of patients stated that the pneumococcal vaccine was offered to them in the last year and 5 years, respectively.¹ Providers can have a strong impact on people obtaining vaccines; over half of patients receive vaccines when their provider recommends it.^1,4 As a medical community focused on respiratory health, we need to prioritize offering vaccinations during inpatient and outpatient encounters.

By Jamie R. Felzer, MD, MPH

Network Member

Cassie C. Kennedy, MD, FCCP

Vice Chair, Council of Networks

Dr. Felzer is a Fellow and Dr. Kennedy is Associate Professor of Medicine, Division of Pulmonary and Critical Care Medicine, Mayo Clinic, Rochester, MN.

References

1. Gatwood J et al. Am J Health Promot. 2021;35:908.

2. Wong LP et al. Infect Dis Poverty. 2021;10:122.

3. Crane MA et al. Health Aff (Millwood). 2021;40:1792.

4. Strully KW et al. Front Public Health. 2021;9:645268.