News from the FDA/CDC

The surge in drug overdose deaths in the United States during the first 2 years of the pandemic appears to have stabilized, according to newly released figures from the Centers for Disease Control and Prevention.

Overdose deaths in 2022 totaled an estimated 109,680 people, which is 2% more than the 107,573 deaths in 2021, according to the figures. But the 2022 total is still a record for the third straight year.

Public health officials are now in a hopeful position. If the 2022 data represents a peak, then the country will see deaths decline toward pre-pandemic levels. If overdose deaths instead have reached a plateau, it means that the United States will sustain the nearly 20% leap that came amid a deadly increase in drug use in 2020 and 2021.

“The fact that it does seem to be flattening out, at least at a national level, is encouraging,” Columbia University epidemiologist Katherine Keyes, PhD, MPH, told The Associated Press. “But these numbers are still extraordinarily high. We shouldn’t suggest the crisis is in any way over.”

The newly released figures from the CDC are considered estimates because some states may still send updated 2022 information later this year.

Although the number of deaths from 2021 to 2022 was stable on a national level, the picture varied more widely at the state level. More than half of U.S. states saw increases, while deaths in 23 states decreased, and just one – Iowa – had the same number of overdose deaths in 2021 and 2022.

The states with the highest counts in 2022 were:

• California: 11,978 deaths
• Florida: 8,032 deaths
• Texas: 5,607 deaths
• Pennsylvania: 5,222 deaths
• Ohio: 5,103 deaths

Synthetic opioids, such as fentanyl and tramadol, account for most drug overdose deaths, according to a December 2022 report from the CDC. 

State officials told The AP that they believe the plateau in overdose deaths is in part due to educational campaigns to warn the public about the dangers of drug use, as well as from expanded addiction treatment and increased access to the overdose-reversal medicine naloxone. 

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

The surge in drug overdose deaths in the United States during the first 2 years of the pandemic appears to have stabilized, according to newly released figures from the Centers for Disease Control and Prevention.

Overdose deaths in 2022 totaled an estimated 109,680 people, which is 2% more than the 107,573 deaths in 2021, according to the figures. But the 2022 total is still a record for the third straight year.

Public health officials are now in a hopeful position. If the 2022 data represents a peak, then the country will see deaths decline toward pre-pandemic levels. If overdose deaths instead have reached a plateau, it means that the United States will sustain the nearly 20% leap that came amid a deadly increase in drug use in 2020 and 2021.

“The fact that it does seem to be flattening out, at least at a national level, is encouraging,” Columbia University epidemiologist Katherine Keyes, PhD, MPH, told The Associated Press. “But these numbers are still extraordinarily high. We shouldn’t suggest the crisis is in any way over.”

The newly released figures from the CDC are considered estimates because some states may still send updated 2022 information later this year.

Although the number of deaths from 2021 to 2022 was stable on a national level, the picture varied more widely at the state level. More than half of U.S. states saw increases, while deaths in 23 states decreased, and just one – Iowa – had the same number of overdose deaths in 2021 and 2022.

The states with the highest counts in 2022 were:

• California: 11,978 deaths
• Florida: 8,032 deaths
• Texas: 5,607 deaths
• Pennsylvania: 5,222 deaths
• Ohio: 5,103 deaths

Synthetic opioids, such as fentanyl and tramadol, account for most drug overdose deaths, according to a December 2022 report from the CDC. 

State officials told The AP that they believe the plateau in overdose deaths is in part due to educational campaigns to warn the public about the dangers of drug use, as well as from expanded addiction treatment and increased access to the overdose-reversal medicine naloxone. 

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

The surge in drug overdose deaths in the United States during the first 2 years of the pandemic appears to have stabilized, according to newly released figures from the Centers for Disease Control and Prevention.

Overdose deaths in 2022 totaled an estimated 109,680 people, which is 2% more than the 107,573 deaths in 2021, according to the figures. But the 2022 total is still a record for the third straight year.

Public health officials are now in a hopeful position. If the 2022 data represents a peak, then the country will see deaths decline toward pre-pandemic levels. If overdose deaths instead have reached a plateau, it means that the United States will sustain the nearly 20% leap that came amid a deadly increase in drug use in 2020 and 2021.

“The fact that it does seem to be flattening out, at least at a national level, is encouraging,” Columbia University epidemiologist Katherine Keyes, PhD, MPH, told The Associated Press. “But these numbers are still extraordinarily high. We shouldn’t suggest the crisis is in any way over.”

The newly released figures from the CDC are considered estimates because some states may still send updated 2022 information later this year.

Although the number of deaths from 2021 to 2022 was stable on a national level, the picture varied more widely at the state level. More than half of U.S. states saw increases, while deaths in 23 states decreased, and just one – Iowa – had the same number of overdose deaths in 2021 and 2022.

The states with the highest counts in 2022 were:

• California: 11,978 deaths
• Florida: 8,032 deaths
• Texas: 5,607 deaths
• Pennsylvania: 5,222 deaths
• Ohio: 5,103 deaths

Synthetic opioids, such as fentanyl and tramadol, account for most drug overdose deaths, according to a December 2022 report from the CDC. 

State officials told The AP that they believe the plateau in overdose deaths is in part due to educational campaigns to warn the public about the dangers of drug use, as well as from expanded addiction treatment and increased access to the overdose-reversal medicine naloxone. 

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

A resurgence of mpox this summer could be larger than last year’s caseload, the Centers for Disease Control and Prevention said in a warning to public health officials this week.

“The outbreak is not over,” the CDC alert stated, noting that springtime and summertime gatherings and festivals could lead to renewed virus spread. A new cluster of 13 cases is being investigated in Chicago, all among men, and four among people who recently traveled to New York City, New Orleans, or Mexico. 

Mpox, formerly called monkeypox, is a virus that causes a rash and sometimes flulike symptoms. It is most often transmitted through sexual contact, but it can also be spread in nonsexual ways that involve contact with skin lesions or with saliva or upper respiratory secretions like snot or mucus, the CDC says. Most cases in the United States have been among gay or bisexual men, men who have sex with men, and transgender people.

Last year, the U.S. government declared mpox a public health emergency as cases peaked at 460 per day in August, infecting more than 30,000 people and killing 42 people. Public health officials worked to quickly distribute vaccinations to people at high risk for contracting the virus. The CDC says 23% of people most at risk of getting mpox have been vaccinated.

The agency advises that people be vaccinated for mpox based on their potential exposure risk. Vaccination does not necessarily prevent infection but can lessen the severity of symptoms. Nine of the men who were recently infected in Chicago were fully vaccinated.

“It’s important to remember that vaccines, while incredibly helpful, are not our only way to reduce the risk of contracting mpox,” Richard Silvera, MD, MPH, of the department of infectious diseases at Icahn School of Medicine at Mount Sinai, New York, told ABC News. 

Other ways to reduce risk are “things like avoiding social and sexual contact if you have new skin lesions and asking your intimate contacts if they are experiencing symptoms or new skin changes,” Dr. Silvera said.

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

A resurgence of mpox this summer could be larger than last year’s caseload, the Centers for Disease Control and Prevention said in a warning to public health officials this week.

“The outbreak is not over,” the CDC alert stated, noting that springtime and summertime gatherings and festivals could lead to renewed virus spread. A new cluster of 13 cases is being investigated in Chicago, all among men, and four among people who recently traveled to New York City, New Orleans, or Mexico. 

Mpox, formerly called monkeypox, is a virus that causes a rash and sometimes flulike symptoms. It is most often transmitted through sexual contact, but it can also be spread in nonsexual ways that involve contact with skin lesions or with saliva or upper respiratory secretions like snot or mucus, the CDC says. Most cases in the United States have been among gay or bisexual men, men who have sex with men, and transgender people.

Last year, the U.S. government declared mpox a public health emergency as cases peaked at 460 per day in August, infecting more than 30,000 people and killing 42 people. Public health officials worked to quickly distribute vaccinations to people at high risk for contracting the virus. The CDC says 23% of people most at risk of getting mpox have been vaccinated.

The agency advises that people be vaccinated for mpox based on their potential exposure risk. Vaccination does not necessarily prevent infection but can lessen the severity of symptoms. Nine of the men who were recently infected in Chicago were fully vaccinated.

“It’s important to remember that vaccines, while incredibly helpful, are not our only way to reduce the risk of contracting mpox,” Richard Silvera, MD, MPH, of the department of infectious diseases at Icahn School of Medicine at Mount Sinai, New York, told ABC News. 

Other ways to reduce risk are “things like avoiding social and sexual contact if you have new skin lesions and asking your intimate contacts if they are experiencing symptoms or new skin changes,” Dr. Silvera said.

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

A resurgence of mpox this summer could be larger than last year’s caseload, the Centers for Disease Control and Prevention said in a warning to public health officials this week.

“The outbreak is not over,” the CDC alert stated, noting that springtime and summertime gatherings and festivals could lead to renewed virus spread. A new cluster of 13 cases is being investigated in Chicago, all among men, and four among people who recently traveled to New York City, New Orleans, or Mexico. 

Mpox, formerly called monkeypox, is a virus that causes a rash and sometimes flulike symptoms. It is most often transmitted through sexual contact, but it can also be spread in nonsexual ways that involve contact with skin lesions or with saliva or upper respiratory secretions like snot or mucus, the CDC says. Most cases in the United States have been among gay or bisexual men, men who have sex with men, and transgender people.

Last year, the U.S. government declared mpox a public health emergency as cases peaked at 460 per day in August, infecting more than 30,000 people and killing 42 people. Public health officials worked to quickly distribute vaccinations to people at high risk for contracting the virus. The CDC says 23% of people most at risk of getting mpox have been vaccinated.

The agency advises that people be vaccinated for mpox based on their potential exposure risk. Vaccination does not necessarily prevent infection but can lessen the severity of symptoms. Nine of the men who were recently infected in Chicago were fully vaccinated.

“It’s important to remember that vaccines, while incredibly helpful, are not our only way to reduce the risk of contracting mpox,” Richard Silvera, MD, MPH, of the department of infectious diseases at Icahn School of Medicine at Mount Sinai, New York, told ABC News. 

Other ways to reduce risk are “things like avoiding social and sexual contact if you have new skin lesions and asking your intimate contacts if they are experiencing symptoms or new skin changes,” Dr. Silvera said.

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

When the federal government’s public health emergency (PHE) ended on May 11, the Centers for Disease Control and Prevention scaled back the amount of COVID-related data that it had required hospitals to collect and report during the previous 3 years. The CDC had to do this, an agency spokesman said in an interview, because “CDC’s authorizations to collect certain types of public health data” expired with the PHE.

The question that arises from this policy change is whether the CDC will now have sufficient information on the evolution and spread of COVID to inform public health decisions in a timely manner. The CDC insists that it will have enough data to keep up with the virus, which repeatedly defied scientists’ expectations during the course of the pandemic. But some experts have doubts about whether this will turn out to be the case.

While the COVID pandemic is subsiding and transitioning to an endemic phase, many things about the coronavirus are still not understood, noted Marisa Eisenberg, PhD, associate professor of epidemiology at the University of Michigan, Ann Arbor.

“COVID is here to stay, and it ebbs and flows but is staying at fairly consistent levels across the country,” she said in an interview. “Meanwhile, we haven’t established a regular seasonality for COVID that we see for most other respiratory illnesses. We’re still seeing pretty rapidly invading new waves of variants. With flu and other respiratory illnesses, you often see a particular variant in each season. There’s an established pattern. For COVID, that’s still shifting.”

Similarly, Sam Scarpino, PhD, a public health expert at Northeastern University, Boston, told the New York Times: “The CDC is shuffling COVID into the deck of infectious diseases that we’re satisfied living with. One thousand deaths a week is just unacceptable.”

William Schaffner, MD, a professor of preventive medicine and health policy at Vanderbilt University Medical Center, Nashville, Tenn., said in an interview that “how we deal with influenza is something of a template or a model for what the CDC is trying to get to with COVID.” It’s not practical for physicians and hospitals to report every flu case, and the same is now true for COVID. However, “we’re still asking for data on people who are hospitalized with COVID to be reported. That will give us a measure of the major public health impact.”

Dr. Eisenberg doesn’t fully subscribe to this notion. “COVID and influenza are both respiratory illnesses, and our initial pandemic response was based on playbooks that we’d built for potential flu pandemics. But COVID is not the flu. We still have to grapple with the fact that it’s killing a lot more people than the flu does. So maybe it’s a template, but not a perfect one.”
 

What data is being deleted

The CDC is now requiring hospitals to submit COVID-related data weekly, rather than daily, as it previously had. In addition, the agency has cut the number of data elements that hospitals must report from 62 to 44. Among the data fields that are now optional for hospitals to report are the numbers of hospitalized children with suspected or lab-confirmed COVID; hospitalized and ventilated COVID patients; adults in the ICU with suspected or lab-confirmed COVID; adult and pediatric admissions with suspected COVID; COVID-related emergency department visits; and inpatients with hospital-acquired COVID.

Although widely feared by health care workers and the public, hospital-acquired COVID has never been a major factor in the pandemic, Dr. Schaffner said. “So why ask for something that’s actually not so critical? Let’s keep the emphasis on rapid, accurate reporting of people who are hospitalized because of this disease.”

Akin Demehin, senior director for quality and patient safety policy for the American Hospital Association, agreed that the rate of hospital-acquired COVID cases “has been very low throughout the pandemic.” That was one reason why CDC made this measure optional.

Dr. Eisenberg concurred with this view. “We worried about [hospital-acquired COVID] a lot, and then, because people were very careful, it wasn’t as much of a problem as we feared it would be.” But she added a note of caution: “Masking and other [preventive guidelines] are shifting in hospitals, so it will be interesting to see whether that affects things.”
 

CDC justifies its new policy

To put the hospital data reporting changes in context, it’s important to know that CDC will no longer directly track community levels of COVID and the percentage of tests that come back positive for COVID, which until now were used to measure transmission rates. (Laboratories no longer have to report these test data, whether they are in hospitals or in the community.) To track death rates, CDC will rely on the National Vital Statistics System, which is accurate but lags other kinds of surveillance by 2-3 weeks, according to the New York Times.

In a recent MMWR report, CDC defended its new COVID surveillance system, saying: “Weekly COVID-19 hospital admission levels and the percentage of all COVID-19–associated deaths will be primary surveillance indicators. Emergency department visits and percentage of positive SARS-CoV-2 laboratory test results will help detect early changes in trends. Genomic surveillance will continue to help identify and monitor SARS-CoV-2 variants.”

Clarifying the latter point, CDC said that national genomic surveillance, along with wastewater surveillance, will continue to be used to estimate COVID variant proportions. Dr. Eisenberg stressed the importance of genomic surveillance at the hundreds of sites that CDC now maintains across the country. But currently, many of these sites are only monitoring the level of COVID.

CDC also observed that COVID-19 hospital admission levels have been shown to be “concordant” with community levels of SARS-CoV-2 infection. Therefore, rates of COVID-associated admissions and the percentages of positive test results, COVID ED visits, and COVID deaths are “suitable and timely indicators of trends in COVID-19 activity and severity.”
 

Ready to shift to voluntary reporting?

In a news release, AHA praised the “streamlining” of CDC requirements for data reporting but said that it hoped that mandatory reporting would be phased out as soon as possible.

The association noted that this would require action by the Centers for Medicare & Medicaid Services. CMS now enforces the CDC requirements with a “condition of participation” (COP) provision, by which noncompliant hospitals could be excluded from Medicare. CMS has extended this COP to April 30, 2024, although it could choose to ask the Secretary of Health and Human Services to terminate it earlier.

If mandatory reporting were repealed, would most hospitals still report on the key COVID metrics? Mr. Demehin noted that before CMS implemented its COP, hospitals reported COVID data voluntarily, “and the participation rate was well over 90%. So setting up a mechanism similar to that is something we’ve encouraged CMS to consider.”

Dr. Eisenberg is skeptical. While bigger hospitals with more resources might continue reporting voluntarily, she said, safety-net hospitals in underserved areas might not, because they are especially short staffed. “Then you have disparities in which hospitals will report.”
 

Vaccinations: The sleeping dragon

COVID continues to ravage the nation. According to CDC statistics, there were 1,109 deaths from COVID in the U.S. in the week ending May 6, and total deaths have hit 1.13 million. There were 1,333 new COVID-related hospital admissions, and 7,261 people were in the hospital because of COVID.

Another eye-catching number: Only 16.9% of the U.S. population has received an updated COVID vaccine booster. Dr. Schaffner thinks that this is what we should really keep our eye on. While the combination of vaccinations and widespread SARS-CoV-2 infections has conferred herd immunity on most Americans, he said it’s temporary. “Whether your immunity comes from the virus and recovery from disease or from the vaccines, that immunity will wane over time. Unless we keep our vaccination rate up, we may see more future cases. We’ll have to see how that works out. But I’m nervous about that, because people do appear to be nonchalant.”

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

When the federal government’s public health emergency (PHE) ended on May 11, the Centers for Disease Control and Prevention scaled back the amount of COVID-related data that it had required hospitals to collect and report during the previous 3 years. The CDC had to do this, an agency spokesman said in an interview, because “CDC’s authorizations to collect certain types of public health data” expired with the PHE.

The question that arises from this policy change is whether the CDC will now have sufficient information on the evolution and spread of COVID to inform public health decisions in a timely manner. The CDC insists that it will have enough data to keep up with the virus, which repeatedly defied scientists’ expectations during the course of the pandemic. But some experts have doubts about whether this will turn out to be the case.

While the COVID pandemic is subsiding and transitioning to an endemic phase, many things about the coronavirus are still not understood, noted Marisa Eisenberg, PhD, associate professor of epidemiology at the University of Michigan, Ann Arbor.

“COVID is here to stay, and it ebbs and flows but is staying at fairly consistent levels across the country,” she said in an interview. “Meanwhile, we haven’t established a regular seasonality for COVID that we see for most other respiratory illnesses. We’re still seeing pretty rapidly invading new waves of variants. With flu and other respiratory illnesses, you often see a particular variant in each season. There’s an established pattern. For COVID, that’s still shifting.”

Similarly, Sam Scarpino, PhD, a public health expert at Northeastern University, Boston, told the New York Times: “The CDC is shuffling COVID into the deck of infectious diseases that we’re satisfied living with. One thousand deaths a week is just unacceptable.”

William Schaffner, MD, a professor of preventive medicine and health policy at Vanderbilt University Medical Center, Nashville, Tenn., said in an interview that “how we deal with influenza is something of a template or a model for what the CDC is trying to get to with COVID.” It’s not practical for physicians and hospitals to report every flu case, and the same is now true for COVID. However, “we’re still asking for data on people who are hospitalized with COVID to be reported. That will give us a measure of the major public health impact.”

Dr. Eisenberg doesn’t fully subscribe to this notion. “COVID and influenza are both respiratory illnesses, and our initial pandemic response was based on playbooks that we’d built for potential flu pandemics. But COVID is not the flu. We still have to grapple with the fact that it’s killing a lot more people than the flu does. So maybe it’s a template, but not a perfect one.”
 

What data is being deleted

The CDC is now requiring hospitals to submit COVID-related data weekly, rather than daily, as it previously had. In addition, the agency has cut the number of data elements that hospitals must report from 62 to 44. Among the data fields that are now optional for hospitals to report are the numbers of hospitalized children with suspected or lab-confirmed COVID; hospitalized and ventilated COVID patients; adults in the ICU with suspected or lab-confirmed COVID; adult and pediatric admissions with suspected COVID; COVID-related emergency department visits; and inpatients with hospital-acquired COVID.

Although widely feared by health care workers and the public, hospital-acquired COVID has never been a major factor in the pandemic, Dr. Schaffner said. “So why ask for something that’s actually not so critical? Let’s keep the emphasis on rapid, accurate reporting of people who are hospitalized because of this disease.”

Akin Demehin, senior director for quality and patient safety policy for the American Hospital Association, agreed that the rate of hospital-acquired COVID cases “has been very low throughout the pandemic.” That was one reason why CDC made this measure optional.

Dr. Eisenberg concurred with this view. “We worried about [hospital-acquired COVID] a lot, and then, because people were very careful, it wasn’t as much of a problem as we feared it would be.” But she added a note of caution: “Masking and other [preventive guidelines] are shifting in hospitals, so it will be interesting to see whether that affects things.”
 

CDC justifies its new policy

To put the hospital data reporting changes in context, it’s important to know that CDC will no longer directly track community levels of COVID and the percentage of tests that come back positive for COVID, which until now were used to measure transmission rates. (Laboratories no longer have to report these test data, whether they are in hospitals or in the community.) To track death rates, CDC will rely on the National Vital Statistics System, which is accurate but lags other kinds of surveillance by 2-3 weeks, according to the New York Times.

In a recent MMWR report, CDC defended its new COVID surveillance system, saying: “Weekly COVID-19 hospital admission levels and the percentage of all COVID-19–associated deaths will be primary surveillance indicators. Emergency department visits and percentage of positive SARS-CoV-2 laboratory test results will help detect early changes in trends. Genomic surveillance will continue to help identify and monitor SARS-CoV-2 variants.”

Clarifying the latter point, CDC said that national genomic surveillance, along with wastewater surveillance, will continue to be used to estimate COVID variant proportions. Dr. Eisenberg stressed the importance of genomic surveillance at the hundreds of sites that CDC now maintains across the country. But currently, many of these sites are only monitoring the level of COVID.

CDC also observed that COVID-19 hospital admission levels have been shown to be “concordant” with community levels of SARS-CoV-2 infection. Therefore, rates of COVID-associated admissions and the percentages of positive test results, COVID ED visits, and COVID deaths are “suitable and timely indicators of trends in COVID-19 activity and severity.”
 

Ready to shift to voluntary reporting?

In a news release, AHA praised the “streamlining” of CDC requirements for data reporting but said that it hoped that mandatory reporting would be phased out as soon as possible.

The association noted that this would require action by the Centers for Medicare & Medicaid Services. CMS now enforces the CDC requirements with a “condition of participation” (COP) provision, by which noncompliant hospitals could be excluded from Medicare. CMS has extended this COP to April 30, 2024, although it could choose to ask the Secretary of Health and Human Services to terminate it earlier.

If mandatory reporting were repealed, would most hospitals still report on the key COVID metrics? Mr. Demehin noted that before CMS implemented its COP, hospitals reported COVID data voluntarily, “and the participation rate was well over 90%. So setting up a mechanism similar to that is something we’ve encouraged CMS to consider.”

Dr. Eisenberg is skeptical. While bigger hospitals with more resources might continue reporting voluntarily, she said, safety-net hospitals in underserved areas might not, because they are especially short staffed. “Then you have disparities in which hospitals will report.”
 

Vaccinations: The sleeping dragon

COVID continues to ravage the nation. According to CDC statistics, there were 1,109 deaths from COVID in the U.S. in the week ending May 6, and total deaths have hit 1.13 million. There were 1,333 new COVID-related hospital admissions, and 7,261 people were in the hospital because of COVID.

Another eye-catching number: Only 16.9% of the U.S. population has received an updated COVID vaccine booster. Dr. Schaffner thinks that this is what we should really keep our eye on. While the combination of vaccinations and widespread SARS-CoV-2 infections has conferred herd immunity on most Americans, he said it’s temporary. “Whether your immunity comes from the virus and recovery from disease or from the vaccines, that immunity will wane over time. Unless we keep our vaccination rate up, we may see more future cases. We’ll have to see how that works out. But I’m nervous about that, because people do appear to be nonchalant.”

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

When the federal government’s public health emergency (PHE) ended on May 11, the Centers for Disease Control and Prevention scaled back the amount of COVID-related data that it had required hospitals to collect and report during the previous 3 years. The CDC had to do this, an agency spokesman said in an interview, because “CDC’s authorizations to collect certain types of public health data” expired with the PHE.

The question that arises from this policy change is whether the CDC will now have sufficient information on the evolution and spread of COVID to inform public health decisions in a timely manner. The CDC insists that it will have enough data to keep up with the virus, which repeatedly defied scientists’ expectations during the course of the pandemic. But some experts have doubts about whether this will turn out to be the case.

While the COVID pandemic is subsiding and transitioning to an endemic phase, many things about the coronavirus are still not understood, noted Marisa Eisenberg, PhD, associate professor of epidemiology at the University of Michigan, Ann Arbor.

“COVID is here to stay, and it ebbs and flows but is staying at fairly consistent levels across the country,” she said in an interview. “Meanwhile, we haven’t established a regular seasonality for COVID that we see for most other respiratory illnesses. We’re still seeing pretty rapidly invading new waves of variants. With flu and other respiratory illnesses, you often see a particular variant in each season. There’s an established pattern. For COVID, that’s still shifting.”

Similarly, Sam Scarpino, PhD, a public health expert at Northeastern University, Boston, told the New York Times: “The CDC is shuffling COVID into the deck of infectious diseases that we’re satisfied living with. One thousand deaths a week is just unacceptable.”

William Schaffner, MD, a professor of preventive medicine and health policy at Vanderbilt University Medical Center, Nashville, Tenn., said in an interview that “how we deal with influenza is something of a template or a model for what the CDC is trying to get to with COVID.” It’s not practical for physicians and hospitals to report every flu case, and the same is now true for COVID. However, “we’re still asking for data on people who are hospitalized with COVID to be reported. That will give us a measure of the major public health impact.”

Dr. Eisenberg doesn’t fully subscribe to this notion. “COVID and influenza are both respiratory illnesses, and our initial pandemic response was based on playbooks that we’d built for potential flu pandemics. But COVID is not the flu. We still have to grapple with the fact that it’s killing a lot more people than the flu does. So maybe it’s a template, but not a perfect one.”
 

What data is being deleted

The CDC is now requiring hospitals to submit COVID-related data weekly, rather than daily, as it previously had. In addition, the agency has cut the number of data elements that hospitals must report from 62 to 44. Among the data fields that are now optional for hospitals to report are the numbers of hospitalized children with suspected or lab-confirmed COVID; hospitalized and ventilated COVID patients; adults in the ICU with suspected or lab-confirmed COVID; adult and pediatric admissions with suspected COVID; COVID-related emergency department visits; and inpatients with hospital-acquired COVID.

Although widely feared by health care workers and the public, hospital-acquired COVID has never been a major factor in the pandemic, Dr. Schaffner said. “So why ask for something that’s actually not so critical? Let’s keep the emphasis on rapid, accurate reporting of people who are hospitalized because of this disease.”

Akin Demehin, senior director for quality and patient safety policy for the American Hospital Association, agreed that the rate of hospital-acquired COVID cases “has been very low throughout the pandemic.” That was one reason why CDC made this measure optional.

Dr. Eisenberg concurred with this view. “We worried about [hospital-acquired COVID] a lot, and then, because people were very careful, it wasn’t as much of a problem as we feared it would be.” But she added a note of caution: “Masking and other [preventive guidelines] are shifting in hospitals, so it will be interesting to see whether that affects things.”
 

CDC justifies its new policy

To put the hospital data reporting changes in context, it’s important to know that CDC will no longer directly track community levels of COVID and the percentage of tests that come back positive for COVID, which until now were used to measure transmission rates. (Laboratories no longer have to report these test data, whether they are in hospitals or in the community.) To track death rates, CDC will rely on the National Vital Statistics System, which is accurate but lags other kinds of surveillance by 2-3 weeks, according to the New York Times.

In a recent MMWR report, CDC defended its new COVID surveillance system, saying: “Weekly COVID-19 hospital admission levels and the percentage of all COVID-19–associated deaths will be primary surveillance indicators. Emergency department visits and percentage of positive SARS-CoV-2 laboratory test results will help detect early changes in trends. Genomic surveillance will continue to help identify and monitor SARS-CoV-2 variants.”

Clarifying the latter point, CDC said that national genomic surveillance, along with wastewater surveillance, will continue to be used to estimate COVID variant proportions. Dr. Eisenberg stressed the importance of genomic surveillance at the hundreds of sites that CDC now maintains across the country. But currently, many of these sites are only monitoring the level of COVID.

CDC also observed that COVID-19 hospital admission levels have been shown to be “concordant” with community levels of SARS-CoV-2 infection. Therefore, rates of COVID-associated admissions and the percentages of positive test results, COVID ED visits, and COVID deaths are “suitable and timely indicators of trends in COVID-19 activity and severity.”
 

Ready to shift to voluntary reporting?

In a news release, AHA praised the “streamlining” of CDC requirements for data reporting but said that it hoped that mandatory reporting would be phased out as soon as possible.

The association noted that this would require action by the Centers for Medicare & Medicaid Services. CMS now enforces the CDC requirements with a “condition of participation” (COP) provision, by which noncompliant hospitals could be excluded from Medicare. CMS has extended this COP to April 30, 2024, although it could choose to ask the Secretary of Health and Human Services to terminate it earlier.

If mandatory reporting were repealed, would most hospitals still report on the key COVID metrics? Mr. Demehin noted that before CMS implemented its COP, hospitals reported COVID data voluntarily, “and the participation rate was well over 90%. So setting up a mechanism similar to that is something we’ve encouraged CMS to consider.”

Dr. Eisenberg is skeptical. While bigger hospitals with more resources might continue reporting voluntarily, she said, safety-net hospitals in underserved areas might not, because they are especially short staffed. “Then you have disparities in which hospitals will report.”
 

Vaccinations: The sleeping dragon

COVID continues to ravage the nation. According to CDC statistics, there were 1,109 deaths from COVID in the U.S. in the week ending May 6, and total deaths have hit 1.13 million. There were 1,333 new COVID-related hospital admissions, and 7,261 people were in the hospital because of COVID.

Another eye-catching number: Only 16.9% of the U.S. population has received an updated COVID vaccine booster. Dr. Schaffner thinks that this is what we should really keep our eye on. While the combination of vaccinations and widespread SARS-CoV-2 infections has conferred herd immunity on most Americans, he said it’s temporary. “Whether your immunity comes from the virus and recovery from disease or from the vaccines, that immunity will wane over time. Unless we keep our vaccination rate up, we may see more future cases. We’ll have to see how that works out. But I’m nervous about that, because people do appear to be nonchalant.”

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

The Food and Drug Administration has expanded the indication for Abbott Laboratories’ spinal cord stimulation (SCS) devices to include treatment of chronic back pain in patients who have not had, or are not eligible for, back surgery, the company has announced.
 

The new indication spans all of Abbott’s SCS devices in the United States, which include the recharge-free Proclaim SCS family and the rechargeable Eterna SCS platform.

The devices feature the company’s proprietary, low-energy BurstDR stimulation waveform, a form of stimulation therapy that uses bursts of mild electrical energy without causing an abnormal tingling sensation to help disrupt pain signals before they can reach the brain, the company explained.

The expanded indication was supported by results from the DISTINCT study, which enrolled 270 adults suffering from severe, disabling chronic back pain for an average of more than 12 years and who were not eligible for surgery.

The study showed that significantly more patients who were treated with SCS achieved significant improvements in back pain, function, quality of life, and psychological status than peers treated with conservative medical management.

“To date, we have struggled with how to treat people who weren’t considered a good surgical candidate because we didn’t have clear, data-driven treatment options for non-surgical back pain,” Timothy Deer, MD, president and CEO of the Spine and Nerve Centers of the Virginias in Charleston, W.Va., said in a news release.

“This new indication for Abbott’s SCS devices, together with BurstDR stimulation, allows physicians the ability to identify and treat a new group of people, providing them with relief from chronic back pain,” Dr. Deer said.

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

The Food and Drug Administration has expanded the indication for Abbott Laboratories’ spinal cord stimulation (SCS) devices to include treatment of chronic back pain in patients who have not had, or are not eligible for, back surgery, the company has announced.
 

The new indication spans all of Abbott’s SCS devices in the United States, which include the recharge-free Proclaim SCS family and the rechargeable Eterna SCS platform.

The devices feature the company’s proprietary, low-energy BurstDR stimulation waveform, a form of stimulation therapy that uses bursts of mild electrical energy without causing an abnormal tingling sensation to help disrupt pain signals before they can reach the brain, the company explained.

The expanded indication was supported by results from the DISTINCT study, which enrolled 270 adults suffering from severe, disabling chronic back pain for an average of more than 12 years and who were not eligible for surgery.

The study showed that significantly more patients who were treated with SCS achieved significant improvements in back pain, function, quality of life, and psychological status than peers treated with conservative medical management.

“To date, we have struggled with how to treat people who weren’t considered a good surgical candidate because we didn’t have clear, data-driven treatment options for non-surgical back pain,” Timothy Deer, MD, president and CEO of the Spine and Nerve Centers of the Virginias in Charleston, W.Va., said in a news release.

“This new indication for Abbott’s SCS devices, together with BurstDR stimulation, allows physicians the ability to identify and treat a new group of people, providing them with relief from chronic back pain,” Dr. Deer said.

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

The Food and Drug Administration has expanded the indication for Abbott Laboratories’ spinal cord stimulation (SCS) devices to include treatment of chronic back pain in patients who have not had, or are not eligible for, back surgery, the company has announced.
 

The new indication spans all of Abbott’s SCS devices in the United States, which include the recharge-free Proclaim SCS family and the rechargeable Eterna SCS platform.

The devices feature the company’s proprietary, low-energy BurstDR stimulation waveform, a form of stimulation therapy that uses bursts of mild electrical energy without causing an abnormal tingling sensation to help disrupt pain signals before they can reach the brain, the company explained.

The expanded indication was supported by results from the DISTINCT study, which enrolled 270 adults suffering from severe, disabling chronic back pain for an average of more than 12 years and who were not eligible for surgery.

The study showed that significantly more patients who were treated with SCS achieved significant improvements in back pain, function, quality of life, and psychological status than peers treated with conservative medical management.

“To date, we have struggled with how to treat people who weren’t considered a good surgical candidate because we didn’t have clear, data-driven treatment options for non-surgical back pain,” Timothy Deer, MD, president and CEO of the Spine and Nerve Centers of the Virginias in Charleston, W.Va., said in a news release.

“This new indication for Abbott’s SCS devices, together with BurstDR stimulation, allows physicians the ability to identify and treat a new group of people, providing them with relief from chronic back pain,” Dr. Deer said.

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

The Food and Drug Administration has announced new action to address ongoing concerns about misuse, abuse, addiction, and overdose of prescription stimulants used to treat attention-deficit/hyperactivity disorder (ADHD).

“The current prescribing information for some prescription stimulants does not provide up-to-date warnings about the harms of misuse and abuse, and particularly that most individuals who misuse prescription stimulants get their drugs from other family members or peers,” the FDA said in a drug safety communication.

Going forward, updated drug labels will clearly state that patients should never share their prescription stimulants with anyone, and the boxed warning will describe the risks of misuse, abuse, addiction, and overdose consistently for all medicines in the class, the FDA said.

The boxed warning will also advise heath care professionals to monitor patients closely for signs and symptoms of misuse, abuse, and addiction.

Patient medication guides will be updated to educate patients and caregivers about these risks.

The FDA encourages prescribers to assess patient risk of misuse, abuse, and addiction before prescribing a stimulant and to counsel patients not to share the medication.
 

Friends and family

A recent literature review by the FDA found that friends and family members are the most common source of prescription stimulant misuse and abuse (nonmedical use). Estimates of such use range from 56% to 80%.

Misuse/abuse of a patient’s own prescription make up 10%-20% of people who report nonmedical stimulant use.

Less commonly reported sources include drug dealers or strangers (4%-7% of people who report nonmedical use) and the Internet (1%-2%).

The groups at highest risk for misuse/abuse of prescription stimulants are young adults aged 18-25 years, college students, and adolescents and young adults who have been diagnosed with ADHD, the FDA said.

Recent data from the Centers for Disease Control and Prevention show that during the first year of the COVID-19 pandemic, prescriptions for stimulants increased 10% among older children and adults.
 

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

The Food and Drug Administration has announced new action to address ongoing concerns about misuse, abuse, addiction, and overdose of prescription stimulants used to treat attention-deficit/hyperactivity disorder (ADHD).

“The current prescribing information for some prescription stimulants does not provide up-to-date warnings about the harms of misuse and abuse, and particularly that most individuals who misuse prescription stimulants get their drugs from other family members or peers,” the FDA said in a drug safety communication.

Going forward, updated drug labels will clearly state that patients should never share their prescription stimulants with anyone, and the boxed warning will describe the risks of misuse, abuse, addiction, and overdose consistently for all medicines in the class, the FDA said.

The boxed warning will also advise heath care professionals to monitor patients closely for signs and symptoms of misuse, abuse, and addiction.

Patient medication guides will be updated to educate patients and caregivers about these risks.

The FDA encourages prescribers to assess patient risk of misuse, abuse, and addiction before prescribing a stimulant and to counsel patients not to share the medication.
 

Friends and family

A recent literature review by the FDA found that friends and family members are the most common source of prescription stimulant misuse and abuse (nonmedical use). Estimates of such use range from 56% to 80%.

Misuse/abuse of a patient’s own prescription make up 10%-20% of people who report nonmedical stimulant use.

Less commonly reported sources include drug dealers or strangers (4%-7% of people who report nonmedical use) and the Internet (1%-2%).

The groups at highest risk for misuse/abuse of prescription stimulants are young adults aged 18-25 years, college students, and adolescents and young adults who have been diagnosed with ADHD, the FDA said.

Recent data from the Centers for Disease Control and Prevention show that during the first year of the COVID-19 pandemic, prescriptions for stimulants increased 10% among older children and adults.
 

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

The Food and Drug Administration has announced new action to address ongoing concerns about misuse, abuse, addiction, and overdose of prescription stimulants used to treat attention-deficit/hyperactivity disorder (ADHD).

“The current prescribing information for some prescription stimulants does not provide up-to-date warnings about the harms of misuse and abuse, and particularly that most individuals who misuse prescription stimulants get their drugs from other family members or peers,” the FDA said in a drug safety communication.

Going forward, updated drug labels will clearly state that patients should never share their prescription stimulants with anyone, and the boxed warning will describe the risks of misuse, abuse, addiction, and overdose consistently for all medicines in the class, the FDA said.

The boxed warning will also advise heath care professionals to monitor patients closely for signs and symptoms of misuse, abuse, and addiction.

Patient medication guides will be updated to educate patients and caregivers about these risks.

The FDA encourages prescribers to assess patient risk of misuse, abuse, and addiction before prescribing a stimulant and to counsel patients not to share the medication.
 

Friends and family

A recent literature review by the FDA found that friends and family members are the most common source of prescription stimulant misuse and abuse (nonmedical use). Estimates of such use range from 56% to 80%.

Misuse/abuse of a patient’s own prescription make up 10%-20% of people who report nonmedical stimulant use.

Less commonly reported sources include drug dealers or strangers (4%-7% of people who report nonmedical use) and the Internet (1%-2%).

The groups at highest risk for misuse/abuse of prescription stimulants are young adults aged 18-25 years, college students, and adolescents and young adults who have been diagnosed with ADHD, the FDA said.

Recent data from the Centers for Disease Control and Prevention show that during the first year of the COVID-19 pandemic, prescriptions for stimulants increased 10% among older children and adults.
 

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

The U.S. Preventive Services Task Force (USPSTF) on May 9 released a draft recommendation statement and evidence review that provides critical updates to its breast cancer screening recommendations.

The major change: USPSTF proposed reducing the recommended start age for routine screening mammograms from age 50 to age 40. The latest recommendation, which carries a B grade, also calls for screening every other year and sets a cutoff age of 74.

The task force’s A and B ratings indicate strong confidence in the evidence for benefit, meaning that clinicians should encourage their patients to get these services as appropriate.

The influential federal advisory panel last updated these recommendations in 2016. At the time, USPSTF recommended routine screening mammograms starting at age 50, and gave a C grade to starting before that.

In the 2016 recommendations, “we felt a woman could start screening in her 40s depending on how she feels about the harms and benefits in an individualized personal decision,” USPSTF member John Wong, MD, chief of clinical decision making and a primary care physician at Tufts Medical Center in Boston, said in an interview. “In this draft recommendation, we now recommend that all women get screened starting at age 40.”

Two major factors prompted the change, explained Dr. Wong. One is that more women are being diagnosed with breast cancer in their 40s. The other is that a growing body of evidence showing that Black women get breast cancer younger, are more likely to die of breast cancer, and would benefit from earlier screening.

“It is now clear that screening every other year starting at age 40 has the potential to save about 20% more lives among all women and there is even greater potential benefit for Black women, who are much more likely to die from breast cancer,” Dr. Wong said.

The American Cancer Society (ACS) called the draft recommendations a “significant positive change,” while noting that the task force recommendations only apply to women at average risk for breast cancer.

The American College of Radiology (ACR) already recommends yearly mammograms for average risk women starting at age 40. Its latest guidelines on mammography call for women at higher-than-average risk for breast cancer to undergo a risk assessment by age 25 to determine if screening before age 40 is needed.

When asked about the differing views, Debra Monticciolo, MD, division chief for breast imaging at Massachusetts General Hospital, said annual screenings that follow ACR recommendations would save more lives than the every-other-year approach backed by the task force. Dr. Monticciolo also highlighted that the available scientific evidence supports earlier assessment as well as augmented and earlier-than-age-40 screening of many women – particularly Black women.

“These evidence-based updates should spur more-informed doctor–patient conversations and help providers save more lives,” Dr. Monticciolo said in a press release.
 

Insurance access

Typically, upgrading a USPSTF recommendation from C to B leads to better access and insurance coverage for patients. The Affordable Care Act (ACA) of 2010 requires insurers to cover the cost of services that get A and B recommendations from the USPSTF without charging copays – a mandate intended to promote greater use for highly regarded services.

But Congress created a special workaround that effectively makes the ACA mandate apply to the 2002 task force recommendations on mammography. In those recommendations, the task force gave a B grade to screening mammograms every 1 or 2 years starting at age 40 without an age limit. 

Federal lawmakers have sought to provide copay-free access to mammograms for this entire population even when the USPSTF recommendations in 2009 and 2016 gave a C grade to routine screening for women under 50.

Still, “it is important to note that our recommendation is based solely on the science of what works to prevent breast cancer and it is not a recommendation for or against insurance coverage,” the task force acknowledged when unveiling the new draft update. “Coverage decisions involve considerations beyond the evidence about clinical benefit, and in the end, these decisions are the responsibility of payors, regulators, and legislators.”
 

Uncertainties persist

The new draft recommendations also highlight the persistent gaps in knowledge about the uses of mammography, despite years of widespread use of this screening tool.

The updated draft recommendations emphasize the lack of sufficient evidence to address major areas of concern related to screening and treating Black women, older women, women with dense breasts, and those with ductal carcinoma in situ (DCIS).

The task force called for more research addressing the underlying causes of elevated breast cancer mortality rates among Black women.

The USPSTF also issued an ‘I’ statement for providing women with dense breasts additional screening with breast ultrasound or MRI and for screening women older than 75 for breast cancer. Such statements indicate that the available evidence is lacking, poor quality, or conflicting, and thus the USPSTF can’t assess the benefits and harms or make a recommendation for or against providing the preventive service.

“Nearly half of all women have dense breasts, which increases their risk for breast cancer and means that mammograms may not work as well for them. We need to know more about whether and how additional screening might help women with dense breasts stay healthy,” the task force explained.

The task force also called for more research on approaches to reduce the risk for overdiagnosis and overtreatment for breast lesions, such as DCIS, which are identified through screening.

One analysis – the COMET study – is currently underway to assess whether women could be spared surgery for DCIS and opt for watchful waiting instead.

“If we can find that monitoring them carefully, either with or without some sort of endocrine therapy, is just as effective in keeping patients free of invasive cancer as surgery, then I think we could help to de-escalate treatment for this very low-risk group of patients,” Shelley Hwang, MD, MPH, principal investigator of the COMET study, told this news organization in December.

The task force will accept comments from the public on this draft update through June 5.

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

The U.S. Preventive Services Task Force (USPSTF) on May 9 released a draft recommendation statement and evidence review that provides critical updates to its breast cancer screening recommendations.

The major change: USPSTF proposed reducing the recommended start age for routine screening mammograms from age 50 to age 40. The latest recommendation, which carries a B grade, also calls for screening every other year and sets a cutoff age of 74.

The task force’s A and B ratings indicate strong confidence in the evidence for benefit, meaning that clinicians should encourage their patients to get these services as appropriate.

The influential federal advisory panel last updated these recommendations in 2016. At the time, USPSTF recommended routine screening mammograms starting at age 50, and gave a C grade to starting before that.

In the 2016 recommendations, “we felt a woman could start screening in her 40s depending on how she feels about the harms and benefits in an individualized personal decision,” USPSTF member John Wong, MD, chief of clinical decision making and a primary care physician at Tufts Medical Center in Boston, said in an interview. “In this draft recommendation, we now recommend that all women get screened starting at age 40.”

Two major factors prompted the change, explained Dr. Wong. One is that more women are being diagnosed with breast cancer in their 40s. The other is that a growing body of evidence showing that Black women get breast cancer younger, are more likely to die of breast cancer, and would benefit from earlier screening.

“It is now clear that screening every other year starting at age 40 has the potential to save about 20% more lives among all women and there is even greater potential benefit for Black women, who are much more likely to die from breast cancer,” Dr. Wong said.

The American Cancer Society (ACS) called the draft recommendations a “significant positive change,” while noting that the task force recommendations only apply to women at average risk for breast cancer.

The American College of Radiology (ACR) already recommends yearly mammograms for average risk women starting at age 40. Its latest guidelines on mammography call for women at higher-than-average risk for breast cancer to undergo a risk assessment by age 25 to determine if screening before age 40 is needed.

When asked about the differing views, Debra Monticciolo, MD, division chief for breast imaging at Massachusetts General Hospital, said annual screenings that follow ACR recommendations would save more lives than the every-other-year approach backed by the task force. Dr. Monticciolo also highlighted that the available scientific evidence supports earlier assessment as well as augmented and earlier-than-age-40 screening of many women – particularly Black women.

“These evidence-based updates should spur more-informed doctor–patient conversations and help providers save more lives,” Dr. Monticciolo said in a press release.
 

Insurance access

Typically, upgrading a USPSTF recommendation from C to B leads to better access and insurance coverage for patients. The Affordable Care Act (ACA) of 2010 requires insurers to cover the cost of services that get A and B recommendations from the USPSTF without charging copays – a mandate intended to promote greater use for highly regarded services.

But Congress created a special workaround that effectively makes the ACA mandate apply to the 2002 task force recommendations on mammography. In those recommendations, the task force gave a B grade to screening mammograms every 1 or 2 years starting at age 40 without an age limit. 

Federal lawmakers have sought to provide copay-free access to mammograms for this entire population even when the USPSTF recommendations in 2009 and 2016 gave a C grade to routine screening for women under 50.

Still, “it is important to note that our recommendation is based solely on the science of what works to prevent breast cancer and it is not a recommendation for or against insurance coverage,” the task force acknowledged when unveiling the new draft update. “Coverage decisions involve considerations beyond the evidence about clinical benefit, and in the end, these decisions are the responsibility of payors, regulators, and legislators.”
 

Uncertainties persist

The new draft recommendations also highlight the persistent gaps in knowledge about the uses of mammography, despite years of widespread use of this screening tool.

The updated draft recommendations emphasize the lack of sufficient evidence to address major areas of concern related to screening and treating Black women, older women, women with dense breasts, and those with ductal carcinoma in situ (DCIS).

The task force called for more research addressing the underlying causes of elevated breast cancer mortality rates among Black women.

The USPSTF also issued an ‘I’ statement for providing women with dense breasts additional screening with breast ultrasound or MRI and for screening women older than 75 for breast cancer. Such statements indicate that the available evidence is lacking, poor quality, or conflicting, and thus the USPSTF can’t assess the benefits and harms or make a recommendation for or against providing the preventive service.

“Nearly half of all women have dense breasts, which increases their risk for breast cancer and means that mammograms may not work as well for them. We need to know more about whether and how additional screening might help women with dense breasts stay healthy,” the task force explained.

The task force also called for more research on approaches to reduce the risk for overdiagnosis and overtreatment for breast lesions, such as DCIS, which are identified through screening.

One analysis – the COMET study – is currently underway to assess whether women could be spared surgery for DCIS and opt for watchful waiting instead.

“If we can find that monitoring them carefully, either with or without some sort of endocrine therapy, is just as effective in keeping patients free of invasive cancer as surgery, then I think we could help to de-escalate treatment for this very low-risk group of patients,” Shelley Hwang, MD, MPH, principal investigator of the COMET study, told this news organization in December.

The task force will accept comments from the public on this draft update through June 5.

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

The U.S. Preventive Services Task Force (USPSTF) on May 9 released a draft recommendation statement and evidence review that provides critical updates to its breast cancer screening recommendations.

The major change: USPSTF proposed reducing the recommended start age for routine screening mammograms from age 50 to age 40. The latest recommendation, which carries a B grade, also calls for screening every other year and sets a cutoff age of 74.

The task force’s A and B ratings indicate strong confidence in the evidence for benefit, meaning that clinicians should encourage their patients to get these services as appropriate.

The influential federal advisory panel last updated these recommendations in 2016. At the time, USPSTF recommended routine screening mammograms starting at age 50, and gave a C grade to starting before that.

In the 2016 recommendations, “we felt a woman could start screening in her 40s depending on how she feels about the harms and benefits in an individualized personal decision,” USPSTF member John Wong, MD, chief of clinical decision making and a primary care physician at Tufts Medical Center in Boston, said in an interview. “In this draft recommendation, we now recommend that all women get screened starting at age 40.”

Two major factors prompted the change, explained Dr. Wong. One is that more women are being diagnosed with breast cancer in their 40s. The other is that a growing body of evidence showing that Black women get breast cancer younger, are more likely to die of breast cancer, and would benefit from earlier screening.

“It is now clear that screening every other year starting at age 40 has the potential to save about 20% more lives among all women and there is even greater potential benefit for Black women, who are much more likely to die from breast cancer,” Dr. Wong said.

The American Cancer Society (ACS) called the draft recommendations a “significant positive change,” while noting that the task force recommendations only apply to women at average risk for breast cancer.

The American College of Radiology (ACR) already recommends yearly mammograms for average risk women starting at age 40. Its latest guidelines on mammography call for women at higher-than-average risk for breast cancer to undergo a risk assessment by age 25 to determine if screening before age 40 is needed.

When asked about the differing views, Debra Monticciolo, MD, division chief for breast imaging at Massachusetts General Hospital, said annual screenings that follow ACR recommendations would save more lives than the every-other-year approach backed by the task force. Dr. Monticciolo also highlighted that the available scientific evidence supports earlier assessment as well as augmented and earlier-than-age-40 screening of many women – particularly Black women.

“These evidence-based updates should spur more-informed doctor–patient conversations and help providers save more lives,” Dr. Monticciolo said in a press release.
 

Insurance access

Typically, upgrading a USPSTF recommendation from C to B leads to better access and insurance coverage for patients. The Affordable Care Act (ACA) of 2010 requires insurers to cover the cost of services that get A and B recommendations from the USPSTF without charging copays – a mandate intended to promote greater use for highly regarded services.

But Congress created a special workaround that effectively makes the ACA mandate apply to the 2002 task force recommendations on mammography. In those recommendations, the task force gave a B grade to screening mammograms every 1 or 2 years starting at age 40 without an age limit. 

Federal lawmakers have sought to provide copay-free access to mammograms for this entire population even when the USPSTF recommendations in 2009 and 2016 gave a C grade to routine screening for women under 50.

Still, “it is important to note that our recommendation is based solely on the science of what works to prevent breast cancer and it is not a recommendation for or against insurance coverage,” the task force acknowledged when unveiling the new draft update. “Coverage decisions involve considerations beyond the evidence about clinical benefit, and in the end, these decisions are the responsibility of payors, regulators, and legislators.”
 

Uncertainties persist

The new draft recommendations also highlight the persistent gaps in knowledge about the uses of mammography, despite years of widespread use of this screening tool.

The updated draft recommendations emphasize the lack of sufficient evidence to address major areas of concern related to screening and treating Black women, older women, women with dense breasts, and those with ductal carcinoma in situ (DCIS).

The task force called for more research addressing the underlying causes of elevated breast cancer mortality rates among Black women.

The USPSTF also issued an ‘I’ statement for providing women with dense breasts additional screening with breast ultrasound or MRI and for screening women older than 75 for breast cancer. Such statements indicate that the available evidence is lacking, poor quality, or conflicting, and thus the USPSTF can’t assess the benefits and harms or make a recommendation for or against providing the preventive service.

“Nearly half of all women have dense breasts, which increases their risk for breast cancer and means that mammograms may not work as well for them. We need to know more about whether and how additional screening might help women with dense breasts stay healthy,” the task force explained.

The task force also called for more research on approaches to reduce the risk for overdiagnosis and overtreatment for breast lesions, such as DCIS, which are identified through screening.

One analysis – the COMET study – is currently underway to assess whether women could be spared surgery for DCIS and opt for watchful waiting instead.

“If we can find that monitoring them carefully, either with or without some sort of endocrine therapy, is just as effective in keeping patients free of invasive cancer as surgery, then I think we could help to de-escalate treatment for this very low-risk group of patients,” Shelley Hwang, MD, MPH, principal investigator of the COMET study, told this news organization in December.

The task force will accept comments from the public on this draft update through June 5.

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

The Food and Drug Administration has expanded the indication of dapagliflozin (Farxiga, AstraZeneca) to include treatment of heart failure across the full spectrum of left ventricular ejection fraction (LVEF) – including HF with mildly reduced ejection fraction (HFmrEF) and with preserved ejection fraction (HFpEF).

The sodium-glucose cotransporter 2 (SGLT2) inhibitor was previously approved in the United States for adults with heart failure with reduced ejection fraction (HFrEF).

The expanded indication is based on data from the phase 3 DELIVER trial, which showed clear clinical benefits of the SGLT2 inhibitor for patients with HF regardless of left ventricular function.

In the trial, which included more than 6,200 patients, dapagliflozin led to a statistically significant and clinically meaningful early reduction in the primary composite endpoint of cardiovascular (CV) death or worsening HF for patients with HFmrEF or HFpEFF.

In addition, results of a pooled analysis of the DAPA-HF and DELIVER phase 3 trials showed a consistent benefit from dapagliflozin treatment in significantly reducing the combined endpoint of CV death or HF hospitalization across the range of LVEF.

The European Commission expanded the indication for dapagliflozin (Forxiga) to include HF across the full spectrum of LVEF in February.

The SGLT2 inhibitor is also approved for use by patients with chronic kidney disease. It was first approved in 2014 to improve glycemic control for patients with diabetes mellitus.

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

The Food and Drug Administration has expanded the indication of dapagliflozin (Farxiga, AstraZeneca) to include treatment of heart failure across the full spectrum of left ventricular ejection fraction (LVEF) – including HF with mildly reduced ejection fraction (HFmrEF) and with preserved ejection fraction (HFpEF).

The sodium-glucose cotransporter 2 (SGLT2) inhibitor was previously approved in the United States for adults with heart failure with reduced ejection fraction (HFrEF).

The expanded indication is based on data from the phase 3 DELIVER trial, which showed clear clinical benefits of the SGLT2 inhibitor for patients with HF regardless of left ventricular function.

In the trial, which included more than 6,200 patients, dapagliflozin led to a statistically significant and clinically meaningful early reduction in the primary composite endpoint of cardiovascular (CV) death or worsening HF for patients with HFmrEF or HFpEFF.

In addition, results of a pooled analysis of the DAPA-HF and DELIVER phase 3 trials showed a consistent benefit from dapagliflozin treatment in significantly reducing the combined endpoint of CV death or HF hospitalization across the range of LVEF.

The European Commission expanded the indication for dapagliflozin (Forxiga) to include HF across the full spectrum of LVEF in February.

The SGLT2 inhibitor is also approved for use by patients with chronic kidney disease. It was first approved in 2014 to improve glycemic control for patients with diabetes mellitus.

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

The Food and Drug Administration has expanded the indication of dapagliflozin (Farxiga, AstraZeneca) to include treatment of heart failure across the full spectrum of left ventricular ejection fraction (LVEF) – including HF with mildly reduced ejection fraction (HFmrEF) and with preserved ejection fraction (HFpEF).

The sodium-glucose cotransporter 2 (SGLT2) inhibitor was previously approved in the United States for adults with heart failure with reduced ejection fraction (HFrEF).

The expanded indication is based on data from the phase 3 DELIVER trial, which showed clear clinical benefits of the SGLT2 inhibitor for patients with HF regardless of left ventricular function.

In the trial, which included more than 6,200 patients, dapagliflozin led to a statistically significant and clinically meaningful early reduction in the primary composite endpoint of cardiovascular (CV) death or worsening HF for patients with HFmrEF or HFpEFF.

In addition, results of a pooled analysis of the DAPA-HF and DELIVER phase 3 trials showed a consistent benefit from dapagliflozin treatment in significantly reducing the combined endpoint of CV death or HF hospitalization across the range of LVEF.

The European Commission expanded the indication for dapagliflozin (Forxiga) to include HF across the full spectrum of LVEF in February.

The SGLT2 inhibitor is also approved for use by patients with chronic kidney disease. It was first approved in 2014 to improve glycemic control for patients with diabetes mellitus.

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

SAN DIEGO – A COVID-19 combination antiviral is the most important new drug primary care physicians have prescribed in recent years – plus it has helped keep many patients out of the hospital, according to a presenter at the annual meeting of the American College of Physicians.

Nirmatrelvir-ritonavir was granted emergency use authorization by the FDA late in 2021 to prevent progression to severe disease when COVID-19 cases and deaths were surging, and the Delta and Omicron variants started to spread.

Gerald Smetana, MD, an internist at Beth Israel Deaconess Medical Center in Boston, discussed nirmatrelvir-ritonavir as an example of how new drugs relevant to primary care can have a profound impact on public health.
 

Understanding the mechanism of action

Nirmatrelvir is the active agent of this combination and inhibits the SARS-CoV-2 main protease (Mpro), which is required for viral replication. In contrast to the SARS-CoV-2 spike protein, Mpro is highly conserved in coronaviruses and rarely acquires mutations. Therefore, unlike monoclonal antibodies targeting the spike protein, nirmatrelvir is active against known Omicron variants and is predicted to remain active against new variants that may emerge. The HIV1 protease inhibitor ritonavir has no activity against SARS-CoV-2. It can help increase the serum concentration of nirmatrelvir by inhibiting its metabolization.

“Although the details are not important for prescribing internists, having a basic understanding of the mechanism of action can help [doctors] better understand for which patients the drugs are indicated,” said Dr. Smetana, also a professor of medicine at Harvard Medical School, Boston. This is particularly important for newly approved drugs with a lot of new information to digest.

“Knowing the mechanisms of action of new drugs can help us predict their efficacy and potential side effects,” said Hubertus Kiefl, MD, an internist at Beth Israel Deaconess Medical Center and a lecturer at Harvard Medical School, during an interview after the session.

Understanding how drugs work also can help clinicians make better decisions, such as avoiding the use of a monoclonal antibody during a surge of a new variant with mutations in surface proteins or carefully managing the use of nirmatrelvir-ritonavir in patients who take certain medications that would cause potentially serious drug-drug interactions, Dr. Kiefl added.

Nirmatrelvir-ritonavir reduces the risk of hospitalization – but only in high-risk patients.

Dr. Smetana presented published data from the EPIC-HR study, a pivotal phase 2-3 clinical trial in 2,246 adult patients with COVID-19, all of whom were unvaccinated. Additionally, all patients had at least one risk factor for progression to severe disease.

When initiated 5 days after symptom onset or earlier, treatment with 300 mg nirmatrelvir plus 100 mg ritonavir twice a day for 5 days led to an 89% relative risk reduction in COVID-19–related hospitalization or death through day 28, compared with placebo.

Subgroup analyses showed that some patients benefited more than others. The highest risk reduction after treatment with nirmatrelvir-ritonavir was observed in patients at least 65 years old.

“It is important to remember that all the patients of this study were unvaccinated and [had] not had prior SARS-CoV-2 infection. This study population isn’t representative of most patients we are seeing today,” said Dr. Smetana.

Unpublished data from a study of standard-risk patients showed a nonsignificant reduction in the risk of hospitalization or death, he said. The study was stopped because of the low rates of hospitalization and death.
 

Effective in real world, but less so than in clinical trials

The fact that the patient cohort in the EPIC-HR trial was different from the patients internists see today makes real-world data critical for determining the usefulness of nirmatrelvir-ritonavir in everyday practice, Dr. Smetana said.

A real-world study from Israel conducted during the first Omicron wave (January to March 2022) showed that treatment with nirmatrelvir alone substantially reduced the relative risk of hospitalization in adults older than 65, with no evidence of benefit in adults aged 40-65. Dr. Smetana highlighted that, unlike the EPIC-HR cohort, most patients in the Israeli study had prior immunity due to vaccination or prior SARS-CoV-2 infection.
 

Many drug-drug interactions, but they can be managed

Nirmatrelvir-ritonavir interacts with many drugs, some of which are commonly used by primary care patients.

To help internists identify drug-drug interactions, Dr. Smetana proposed the use of the Liverpool COVID-19 Drug Interactions Checker, an intuitive tool that can help prescribers identify potential drug-drug interactions, categorize them based on severity, and identify management strategies.

This tool is specific to COVID-19 drugs. The Liverpool group also offers online drug interaction checkers for HIV, hepatitis, and cancer. “We need more tools like this to help improve the safe use of new drugs,” Dr. Smetana said.

To manage drug interactions, according to Dr. Smetana, U.S. treatment guidelines offer the following three options:

• Prescribe an alternative COVID therapy.
• Temporarily withhold concomitant medication if clinically appropriate.
• Adjust the dose of concomitant medication and monitor for adverse effects.

Medication doses that are withheld or modified should be continued through 3 days after completing nirmatrelvir-ritonavir, he added.
 

Important considerations

Commenting on things to consider for patients with COVID-19, Dr. Smetana said that there is a short window after symptom onset when nirmatrelvir-ritonavir can be prescribed, and safety in pregnancy is not known. There is also uncertainty regarding funding of nirmatrelvir-ritonavir prescriptions after the state of emergency is lifted. He reminded attendees that, although nirmatrelvir-ritonavir is the preferred first-line treatment for high-risk patients, another antiviral agent, molnupiravir, is also available and might be more appropriate for some patients.

He also cautioned about prescribing new drugs off label for indications that are not yet FDA-approved. “We are often stewards of limited resources when new drugs first become available but are not yet in sufficient supply to meet demand. Limiting our prescribing to FDA-approved indications helps to ensure equitable access,” he said.

Dr. Smetana and Dr. Kiefl reported no disclosures.

SAN DIEGO – A COVID-19 combination antiviral is the most important new drug primary care physicians have prescribed in recent years – plus it has helped keep many patients out of the hospital, according to a presenter at the annual meeting of the American College of Physicians.

Nirmatrelvir-ritonavir was granted emergency use authorization by the FDA late in 2021 to prevent progression to severe disease when COVID-19 cases and deaths were surging, and the Delta and Omicron variants started to spread.

Gerald Smetana, MD, an internist at Beth Israel Deaconess Medical Center in Boston, discussed nirmatrelvir-ritonavir as an example of how new drugs relevant to primary care can have a profound impact on public health.
 

Understanding the mechanism of action

Nirmatrelvir is the active agent of this combination and inhibits the SARS-CoV-2 main protease (Mpro), which is required for viral replication. In contrast to the SARS-CoV-2 spike protein, Mpro is highly conserved in coronaviruses and rarely acquires mutations. Therefore, unlike monoclonal antibodies targeting the spike protein, nirmatrelvir is active against known Omicron variants and is predicted to remain active against new variants that may emerge. The HIV1 protease inhibitor ritonavir has no activity against SARS-CoV-2. It can help increase the serum concentration of nirmatrelvir by inhibiting its metabolization.

“Although the details are not important for prescribing internists, having a basic understanding of the mechanism of action can help [doctors] better understand for which patients the drugs are indicated,” said Dr. Smetana, also a professor of medicine at Harvard Medical School, Boston. This is particularly important for newly approved drugs with a lot of new information to digest.

“Knowing the mechanisms of action of new drugs can help us predict their efficacy and potential side effects,” said Hubertus Kiefl, MD, an internist at Beth Israel Deaconess Medical Center and a lecturer at Harvard Medical School, during an interview after the session.

Understanding how drugs work also can help clinicians make better decisions, such as avoiding the use of a monoclonal antibody during a surge of a new variant with mutations in surface proteins or carefully managing the use of nirmatrelvir-ritonavir in patients who take certain medications that would cause potentially serious drug-drug interactions, Dr. Kiefl added.

Nirmatrelvir-ritonavir reduces the risk of hospitalization – but only in high-risk patients.

Dr. Smetana presented published data from the EPIC-HR study, a pivotal phase 2-3 clinical trial in 2,246 adult patients with COVID-19, all of whom were unvaccinated. Additionally, all patients had at least one risk factor for progression to severe disease.

When initiated 5 days after symptom onset or earlier, treatment with 300 mg nirmatrelvir plus 100 mg ritonavir twice a day for 5 days led to an 89% relative risk reduction in COVID-19–related hospitalization or death through day 28, compared with placebo.

Subgroup analyses showed that some patients benefited more than others. The highest risk reduction after treatment with nirmatrelvir-ritonavir was observed in patients at least 65 years old.

“It is important to remember that all the patients of this study were unvaccinated and [had] not had prior SARS-CoV-2 infection. This study population isn’t representative of most patients we are seeing today,” said Dr. Smetana.

Unpublished data from a study of standard-risk patients showed a nonsignificant reduction in the risk of hospitalization or death, he said. The study was stopped because of the low rates of hospitalization and death.
 

Effective in real world, but less so than in clinical trials

The fact that the patient cohort in the EPIC-HR trial was different from the patients internists see today makes real-world data critical for determining the usefulness of nirmatrelvir-ritonavir in everyday practice, Dr. Smetana said.

A real-world study from Israel conducted during the first Omicron wave (January to March 2022) showed that treatment with nirmatrelvir alone substantially reduced the relative risk of hospitalization in adults older than 65, with no evidence of benefit in adults aged 40-65. Dr. Smetana highlighted that, unlike the EPIC-HR cohort, most patients in the Israeli study had prior immunity due to vaccination or prior SARS-CoV-2 infection.
 

Many drug-drug interactions, but they can be managed

Nirmatrelvir-ritonavir interacts with many drugs, some of which are commonly used by primary care patients.

To help internists identify drug-drug interactions, Dr. Smetana proposed the use of the Liverpool COVID-19 Drug Interactions Checker, an intuitive tool that can help prescribers identify potential drug-drug interactions, categorize them based on severity, and identify management strategies.

This tool is specific to COVID-19 drugs. The Liverpool group also offers online drug interaction checkers for HIV, hepatitis, and cancer. “We need more tools like this to help improve the safe use of new drugs,” Dr. Smetana said.

To manage drug interactions, according to Dr. Smetana, U.S. treatment guidelines offer the following three options:

• Prescribe an alternative COVID therapy.
• Temporarily withhold concomitant medication if clinically appropriate.
• Adjust the dose of concomitant medication and monitor for adverse effects.

Medication doses that are withheld or modified should be continued through 3 days after completing nirmatrelvir-ritonavir, he added.
 

Important considerations

Commenting on things to consider for patients with COVID-19, Dr. Smetana said that there is a short window after symptom onset when nirmatrelvir-ritonavir can be prescribed, and safety in pregnancy is not known. There is also uncertainty regarding funding of nirmatrelvir-ritonavir prescriptions after the state of emergency is lifted. He reminded attendees that, although nirmatrelvir-ritonavir is the preferred first-line treatment for high-risk patients, another antiviral agent, molnupiravir, is also available and might be more appropriate for some patients.

He also cautioned about prescribing new drugs off label for indications that are not yet FDA-approved. “We are often stewards of limited resources when new drugs first become available but are not yet in sufficient supply to meet demand. Limiting our prescribing to FDA-approved indications helps to ensure equitable access,” he said.

Dr. Smetana and Dr. Kiefl reported no disclosures.

SAN DIEGO – A COVID-19 combination antiviral is the most important new drug primary care physicians have prescribed in recent years – plus it has helped keep many patients out of the hospital, according to a presenter at the annual meeting of the American College of Physicians.

Nirmatrelvir-ritonavir was granted emergency use authorization by the FDA late in 2021 to prevent progression to severe disease when COVID-19 cases and deaths were surging, and the Delta and Omicron variants started to spread.

Gerald Smetana, MD, an internist at Beth Israel Deaconess Medical Center in Boston, discussed nirmatrelvir-ritonavir as an example of how new drugs relevant to primary care can have a profound impact on public health.
 

Understanding the mechanism of action

Nirmatrelvir is the active agent of this combination and inhibits the SARS-CoV-2 main protease (Mpro), which is required for viral replication. In contrast to the SARS-CoV-2 spike protein, Mpro is highly conserved in coronaviruses and rarely acquires mutations. Therefore, unlike monoclonal antibodies targeting the spike protein, nirmatrelvir is active against known Omicron variants and is predicted to remain active against new variants that may emerge. The HIV1 protease inhibitor ritonavir has no activity against SARS-CoV-2. It can help increase the serum concentration of nirmatrelvir by inhibiting its metabolization.

“Although the details are not important for prescribing internists, having a basic understanding of the mechanism of action can help [doctors] better understand for which patients the drugs are indicated,” said Dr. Smetana, also a professor of medicine at Harvard Medical School, Boston. This is particularly important for newly approved drugs with a lot of new information to digest.

“Knowing the mechanisms of action of new drugs can help us predict their efficacy and potential side effects,” said Hubertus Kiefl, MD, an internist at Beth Israel Deaconess Medical Center and a lecturer at Harvard Medical School, during an interview after the session.

Understanding how drugs work also can help clinicians make better decisions, such as avoiding the use of a monoclonal antibody during a surge of a new variant with mutations in surface proteins or carefully managing the use of nirmatrelvir-ritonavir in patients who take certain medications that would cause potentially serious drug-drug interactions, Dr. Kiefl added.

Nirmatrelvir-ritonavir reduces the risk of hospitalization – but only in high-risk patients.

Dr. Smetana presented published data from the EPIC-HR study, a pivotal phase 2-3 clinical trial in 2,246 adult patients with COVID-19, all of whom were unvaccinated. Additionally, all patients had at least one risk factor for progression to severe disease.

When initiated 5 days after symptom onset or earlier, treatment with 300 mg nirmatrelvir plus 100 mg ritonavir twice a day for 5 days led to an 89% relative risk reduction in COVID-19–related hospitalization or death through day 28, compared with placebo.

Subgroup analyses showed that some patients benefited more than others. The highest risk reduction after treatment with nirmatrelvir-ritonavir was observed in patients at least 65 years old.

“It is important to remember that all the patients of this study were unvaccinated and [had] not had prior SARS-CoV-2 infection. This study population isn’t representative of most patients we are seeing today,” said Dr. Smetana.

Unpublished data from a study of standard-risk patients showed a nonsignificant reduction in the risk of hospitalization or death, he said. The study was stopped because of the low rates of hospitalization and death.
 

Effective in real world, but less so than in clinical trials

The fact that the patient cohort in the EPIC-HR trial was different from the patients internists see today makes real-world data critical for determining the usefulness of nirmatrelvir-ritonavir in everyday practice, Dr. Smetana said.

A real-world study from Israel conducted during the first Omicron wave (January to March 2022) showed that treatment with nirmatrelvir alone substantially reduced the relative risk of hospitalization in adults older than 65, with no evidence of benefit in adults aged 40-65. Dr. Smetana highlighted that, unlike the EPIC-HR cohort, most patients in the Israeli study had prior immunity due to vaccination or prior SARS-CoV-2 infection.
 

Many drug-drug interactions, but they can be managed

Nirmatrelvir-ritonavir interacts with many drugs, some of which are commonly used by primary care patients.

To help internists identify drug-drug interactions, Dr. Smetana proposed the use of the Liverpool COVID-19 Drug Interactions Checker, an intuitive tool that can help prescribers identify potential drug-drug interactions, categorize them based on severity, and identify management strategies.

This tool is specific to COVID-19 drugs. The Liverpool group also offers online drug interaction checkers for HIV, hepatitis, and cancer. “We need more tools like this to help improve the safe use of new drugs,” Dr. Smetana said.

To manage drug interactions, according to Dr. Smetana, U.S. treatment guidelines offer the following three options:

• Prescribe an alternative COVID therapy.
• Temporarily withhold concomitant medication if clinically appropriate.
• Adjust the dose of concomitant medication and monitor for adverse effects.

Medication doses that are withheld or modified should be continued through 3 days after completing nirmatrelvir-ritonavir, he added.
 

Important considerations

Commenting on things to consider for patients with COVID-19, Dr. Smetana said that there is a short window after symptom onset when nirmatrelvir-ritonavir can be prescribed, and safety in pregnancy is not known. There is also uncertainty regarding funding of nirmatrelvir-ritonavir prescriptions after the state of emergency is lifted. He reminded attendees that, although nirmatrelvir-ritonavir is the preferred first-line treatment for high-risk patients, another antiviral agent, molnupiravir, is also available and might be more appropriate for some patients.

He also cautioned about prescribing new drugs off label for indications that are not yet FDA-approved. “We are often stewards of limited resources when new drugs first become available but are not yet in sufficient supply to meet demand. Limiting our prescribing to FDA-approved indications helps to ensure equitable access,” he said.

Dr. Smetana and Dr. Kiefl reported no disclosures.

The U.S. Food and Drug Administration has granted Fast Track designation for Cabaletta Bio’s cell therapy CABA-201 for the treatment of systemic lupus erythematosus (SLE) and lupus nephritis (LN), the company announced May 1.
 

The FDA cleared Cabaletta to begin a phase 1/2 clinical trial of CABA-201, the statement says, which will be the first trial accessing Cabaletta’s Chimeric Antigen Receptor T cells for Autoimmunity (CARTA) approach. CABA-201, a 4-1BB–containing fully human CD19-CAR T-cell investigational therapy, is designed to target and deplete CD19-positive B cells, “enabling an ‘immune system reset’ with durable remission in patients with SLE,” according to the press release. This news organization previously reported on a small study in Germany, published in Nature Medicine, that also used anti-CD19 CAR T cells to treat five patients with SLE.

Wikimedia Commons/FitzColinGerald/Creative Commons License

This upcoming open-label study will enroll two cohorts containing six patients each. One cohort will be patients with SLE and active LN, and the other will be patients with SLE without renal involvement. The therapy is designed as a one-time infusion and will be administered at a dose of 1.0 x 106 cells/kg.

“We believe the FDA’s decision to grant Fast Track Designation for CABA-201 underscores the unmet need for a treatment that has the potential to provide deep and durable responses for people living with lupus and potentially other autoimmune diseases where B cells contribute to disease,” David J. Chang, MD, chief medical officer of Cabaletta, said in the press release.

FDA Fast Track is a process designed to expedite the development and review of drugs and other therapeutics that treat serious conditions and address unmet medical needs. Companies that receive Fast Track designation for a drug have the opportunity for more frequent meetings and written communication with the FDA about the drug’s development plan and design of clinical trials. The fast-tracked drug can also be eligible for accelerated approval and priority review if relevant criteria are met.

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

The U.S. Food and Drug Administration has granted Fast Track designation for Cabaletta Bio’s cell therapy CABA-201 for the treatment of systemic lupus erythematosus (SLE) and lupus nephritis (LN), the company announced May 1.
 

The FDA cleared Cabaletta to begin a phase 1/2 clinical trial of CABA-201, the statement says, which will be the first trial accessing Cabaletta’s Chimeric Antigen Receptor T cells for Autoimmunity (CARTA) approach. CABA-201, a 4-1BB–containing fully human CD19-CAR T-cell investigational therapy, is designed to target and deplete CD19-positive B cells, “enabling an ‘immune system reset’ with durable remission in patients with SLE,” according to the press release. This news organization previously reported on a small study in Germany, published in Nature Medicine, that also used anti-CD19 CAR T cells to treat five patients with SLE.

Wikimedia Commons/FitzColinGerald/Creative Commons License

This upcoming open-label study will enroll two cohorts containing six patients each. One cohort will be patients with SLE and active LN, and the other will be patients with SLE without renal involvement. The therapy is designed as a one-time infusion and will be administered at a dose of 1.0 x 106 cells/kg.

“We believe the FDA’s decision to grant Fast Track Designation for CABA-201 underscores the unmet need for a treatment that has the potential to provide deep and durable responses for people living with lupus and potentially other autoimmune diseases where B cells contribute to disease,” David J. Chang, MD, chief medical officer of Cabaletta, said in the press release.

FDA Fast Track is a process designed to expedite the development and review of drugs and other therapeutics that treat serious conditions and address unmet medical needs. Companies that receive Fast Track designation for a drug have the opportunity for more frequent meetings and written communication with the FDA about the drug’s development plan and design of clinical trials. The fast-tracked drug can also be eligible for accelerated approval and priority review if relevant criteria are met.

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

The U.S. Food and Drug Administration has granted Fast Track designation for Cabaletta Bio’s cell therapy CABA-201 for the treatment of systemic lupus erythematosus (SLE) and lupus nephritis (LN), the company announced May 1.
 

The FDA cleared Cabaletta to begin a phase 1/2 clinical trial of CABA-201, the statement says, which will be the first trial accessing Cabaletta’s Chimeric Antigen Receptor T cells for Autoimmunity (CARTA) approach. CABA-201, a 4-1BB–containing fully human CD19-CAR T-cell investigational therapy, is designed to target and deplete CD19-positive B cells, “enabling an ‘immune system reset’ with durable remission in patients with SLE,” according to the press release. This news organization previously reported on a small study in Germany, published in Nature Medicine, that also used anti-CD19 CAR T cells to treat five patients with SLE.

Wikimedia Commons/FitzColinGerald/Creative Commons License

This upcoming open-label study will enroll two cohorts containing six patients each. One cohort will be patients with SLE and active LN, and the other will be patients with SLE without renal involvement. The therapy is designed as a one-time infusion and will be administered at a dose of 1.0 x 106 cells/kg.

“We believe the FDA’s decision to grant Fast Track Designation for CABA-201 underscores the unmet need for a treatment that has the potential to provide deep and durable responses for people living with lupus and potentially other autoimmune diseases where B cells contribute to disease,” David J. Chang, MD, chief medical officer of Cabaletta, said in the press release.

FDA Fast Track is a process designed to expedite the development and review of drugs and other therapeutics that treat serious conditions and address unmet medical needs. Companies that receive Fast Track designation for a drug have the opportunity for more frequent meetings and written communication with the FDA about the drug’s development plan and design of clinical trials. The fast-tracked drug can also be eligible for accelerated approval and priority review if relevant criteria are met.

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

The U.S. Food and Drug Administration (FDA) has approved the first vaccine for respiratory syncytial virus (RSV) in the United States, the agency announced May 3. Arexvy, manufactured by GSK, is the world’s first RSV vaccine for adults aged 60 years and older,the company said in an announcement.

Every year, RSV is responsible for 60,000–120,000 hospitalizations and 6,000–10,000 deaths among U.S. adults older than age, according to the FDA. Older adults with underlying health conditions — such as diabetes, a weakened immune system, or lung or heart disease — are at high risk for severe disease. "Today’s approval of the first RSV vaccine is an important public health achievement to prevent a disease which can be life-threatening and reflects the FDA’s continued commitment to facilitating the development of safe and effective vaccines for use in the United States," said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, in a statement.

The FDA approval of Arexvy was based on a clinical study of approximately 25,000 patients. Half of these patients received Arexvy, while the other half received a placebo. Researchers found that the RSV vaccine reduced RSV-associated lower respiratory tract disease (LRTD) by nearly 83% and reduced the risk of developing severe RSV-associated LRTD by 94%. The most commonly reported side effects were injection site pain, fatigue, muscle pain, headache, and joint stiffness/pain. Ten patients who received Arexvy and four patients who received placebo experienced atrial fibrillation within 30 days of vaccination. The company is planning to assess risk for atrial fibrillation in postmarking studies, the FDA said. The European Medicine Agency’s Committee for Medicinal Products for Human Use recommended approval of Arexvy on April 25, 2023, on the basis of data from the same clinical trial.

GSK said that the U.S. launch of Arexvy will occur sometime in the fall before the 2023/2024 RSV season, but the company did not provide exact dates. "Today marks a turning point in our effort to reduce the significant burden of RSV," said GSK’s chief scientific officer, Tony Wood, PhD, in a company statement. "Our focus now is to ensure eligible older adults in the U.S. can access the vaccine as quickly as possible and to progress regulatory review in other countries."

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

The U.S. Food and Drug Administration (FDA) has approved the first vaccine for respiratory syncytial virus (RSV) in the United States, the agency announced May 3. Arexvy, manufactured by GSK, is the world’s first RSV vaccine for adults aged 60 years and older,the company said in an announcement.

Every year, RSV is responsible for 60,000–120,000 hospitalizations and 6,000–10,000 deaths among U.S. adults older than age, according to the FDA. Older adults with underlying health conditions — such as diabetes, a weakened immune system, or lung or heart disease — are at high risk for severe disease. "Today’s approval of the first RSV vaccine is an important public health achievement to prevent a disease which can be life-threatening and reflects the FDA’s continued commitment to facilitating the development of safe and effective vaccines for use in the United States," said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, in a statement.

The FDA approval of Arexvy was based on a clinical study of approximately 25,000 patients. Half of these patients received Arexvy, while the other half received a placebo. Researchers found that the RSV vaccine reduced RSV-associated lower respiratory tract disease (LRTD) by nearly 83% and reduced the risk of developing severe RSV-associated LRTD by 94%. The most commonly reported side effects were injection site pain, fatigue, muscle pain, headache, and joint stiffness/pain. Ten patients who received Arexvy and four patients who received placebo experienced atrial fibrillation within 30 days of vaccination. The company is planning to assess risk for atrial fibrillation in postmarking studies, the FDA said. The European Medicine Agency’s Committee for Medicinal Products for Human Use recommended approval of Arexvy on April 25, 2023, on the basis of data from the same clinical trial.

GSK said that the U.S. launch of Arexvy will occur sometime in the fall before the 2023/2024 RSV season, but the company did not provide exact dates. "Today marks a turning point in our effort to reduce the significant burden of RSV," said GSK’s chief scientific officer, Tony Wood, PhD, in a company statement. "Our focus now is to ensure eligible older adults in the U.S. can access the vaccine as quickly as possible and to progress regulatory review in other countries."

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

The U.S. Food and Drug Administration (FDA) has approved the first vaccine for respiratory syncytial virus (RSV) in the United States, the agency announced May 3. Arexvy, manufactured by GSK, is the world’s first RSV vaccine for adults aged 60 years and older,the company said in an announcement.

Every year, RSV is responsible for 60,000–120,000 hospitalizations and 6,000–10,000 deaths among U.S. adults older than age, according to the FDA. Older adults with underlying health conditions — such as diabetes, a weakened immune system, or lung or heart disease — are at high risk for severe disease. "Today’s approval of the first RSV vaccine is an important public health achievement to prevent a disease which can be life-threatening and reflects the FDA’s continued commitment to facilitating the development of safe and effective vaccines for use in the United States," said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, in a statement.

The FDA approval of Arexvy was based on a clinical study of approximately 25,000 patients. Half of these patients received Arexvy, while the other half received a placebo. Researchers found that the RSV vaccine reduced RSV-associated lower respiratory tract disease (LRTD) by nearly 83% and reduced the risk of developing severe RSV-associated LRTD by 94%. The most commonly reported side effects were injection site pain, fatigue, muscle pain, headache, and joint stiffness/pain. Ten patients who received Arexvy and four patients who received placebo experienced atrial fibrillation within 30 days of vaccination. The company is planning to assess risk for atrial fibrillation in postmarking studies, the FDA said. The European Medicine Agency’s Committee for Medicinal Products for Human Use recommended approval of Arexvy on April 25, 2023, on the basis of data from the same clinical trial.

GSK said that the U.S. launch of Arexvy will occur sometime in the fall before the 2023/2024 RSV season, but the company did not provide exact dates. "Today marks a turning point in our effort to reduce the significant burden of RSV," said GSK’s chief scientific officer, Tony Wood, PhD, in a company statement. "Our focus now is to ensure eligible older adults in the U.S. can access the vaccine as quickly as possible and to progress regulatory review in other countries."

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