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Prostate cancer drug shortage leaves some with uncertainty
according to the Food and Drug Administration.
The therapy lutetium Lu 177 vipivotide tetraxetan (Pluvicto), approved in March 2022, will remain in limited supply until the drug’s manufacturer, Novartis, can ramp up production of the drug over the next 12 months.
In a letter in February, Novartis said it is giving priority to patients who have already started the regimen so they can “appropriately complete their course of therapy.” The manufacturer will not be taking any orders for new patients over the next 4-6 months, as they work to increase supply.
“We are operating our production site at full capacity to treat as many patients as possible, as quickly as possible,” Novartis said. “However, with a nuclear medicine like Pluvicto, there is no backup supply that we can draw from when we experience a delay.”
Pluvicto is currently made in small batches in the company’s manufacturing facility in Italy. The drug only has a 5-day window to reach its intended patient, after which time it cannot be used. Any disruption in the production or shipping process can create a delay.
Novartis said the facility in Italy is currently operating at full capacity and the company is “working to increase production capacity and supply” of the drug over the next 12 months at two new manufacturing sites in the United States.
The company also encountered supply problems with Pluvicto in 2022 after quality issues were discovered in the manufacturing process.
Currently, patients who are waiting for their first dose of Pluvicto will need to be rescheduled. The manufacturer will be reaching out to health care professionals with options for rescheduling.
Jonathan McConathy, MD, PhD, told The Wall Street Journal that “people will die from this shortage, for sure.”
Dr. McConathy, a radiologist at the University of Alabama at Birmingham who has consulted for Novartis, explained that some patients who would have benefited from the drug likely won’t receive it in time.
A version of this article first appeared on Medscape.com.
according to the Food and Drug Administration.
The therapy lutetium Lu 177 vipivotide tetraxetan (Pluvicto), approved in March 2022, will remain in limited supply until the drug’s manufacturer, Novartis, can ramp up production of the drug over the next 12 months.
In a letter in February, Novartis said it is giving priority to patients who have already started the regimen so they can “appropriately complete their course of therapy.” The manufacturer will not be taking any orders for new patients over the next 4-6 months, as they work to increase supply.
“We are operating our production site at full capacity to treat as many patients as possible, as quickly as possible,” Novartis said. “However, with a nuclear medicine like Pluvicto, there is no backup supply that we can draw from when we experience a delay.”
Pluvicto is currently made in small batches in the company’s manufacturing facility in Italy. The drug only has a 5-day window to reach its intended patient, after which time it cannot be used. Any disruption in the production or shipping process can create a delay.
Novartis said the facility in Italy is currently operating at full capacity and the company is “working to increase production capacity and supply” of the drug over the next 12 months at two new manufacturing sites in the United States.
The company also encountered supply problems with Pluvicto in 2022 after quality issues were discovered in the manufacturing process.
Currently, patients who are waiting for their first dose of Pluvicto will need to be rescheduled. The manufacturer will be reaching out to health care professionals with options for rescheduling.
Jonathan McConathy, MD, PhD, told The Wall Street Journal that “people will die from this shortage, for sure.”
Dr. McConathy, a radiologist at the University of Alabama at Birmingham who has consulted for Novartis, explained that some patients who would have benefited from the drug likely won’t receive it in time.
A version of this article first appeared on Medscape.com.
according to the Food and Drug Administration.
The therapy lutetium Lu 177 vipivotide tetraxetan (Pluvicto), approved in March 2022, will remain in limited supply until the drug’s manufacturer, Novartis, can ramp up production of the drug over the next 12 months.
In a letter in February, Novartis said it is giving priority to patients who have already started the regimen so they can “appropriately complete their course of therapy.” The manufacturer will not be taking any orders for new patients over the next 4-6 months, as they work to increase supply.
“We are operating our production site at full capacity to treat as many patients as possible, as quickly as possible,” Novartis said. “However, with a nuclear medicine like Pluvicto, there is no backup supply that we can draw from when we experience a delay.”
Pluvicto is currently made in small batches in the company’s manufacturing facility in Italy. The drug only has a 5-day window to reach its intended patient, after which time it cannot be used. Any disruption in the production or shipping process can create a delay.
Novartis said the facility in Italy is currently operating at full capacity and the company is “working to increase production capacity and supply” of the drug over the next 12 months at two new manufacturing sites in the United States.
The company also encountered supply problems with Pluvicto in 2022 after quality issues were discovered in the manufacturing process.
Currently, patients who are waiting for their first dose of Pluvicto will need to be rescheduled. The manufacturer will be reaching out to health care professionals with options for rescheduling.
Jonathan McConathy, MD, PhD, told The Wall Street Journal that “people will die from this shortage, for sure.”
Dr. McConathy, a radiologist at the University of Alabama at Birmingham who has consulted for Novartis, explained that some patients who would have benefited from the drug likely won’t receive it in time.
A version of this article first appeared on Medscape.com.
Cases of potentially deadly fungus jump 200%: CDC
prompting the Centers for Disease Control and Prevention to issue a warning to health care facilities about the rising threat.
C. auris is a yeast that spreads easily from touching it on a surface like a countertop. It can also spread from person to person. It isn’t a threat to healthy people, but people in hospitals and nursing homes are at a heightened risk because they might have weakened immune systems or be using invasive medical devices that can introduce the fungus inside their bodies. When C. auris progresses to causing an infection that reaches the brain, blood, or lungs, more than one in three people die.
The worrying increase was detailed in the journal Annals of Internal Medicine. In 2021, cases reached a count of 3,270 with an active infection, and 7,413 cases showed the fungus was present but hadn’t caused an infection. Infection counts were up 95% over the previous year, and the fungus showed up on screenings three times as often. The number of cases resistant to medication also tripled.
The CDC called the figures “alarming,” noting that the fungus was only detected in the United States in 2016.
“The timing of this increase and findings from public health investigations suggest C. auris spread may have worsened due to strain on health care and public health systems during the COVID-19 pandemic,” the CDC explained in a news release.
Another potential reason for the jump could be that screening for C. auris has simply increased and it’s being found more often because it’s being looked for more often. But researchers believe that, even with the increase in testing, the reported counts are underestimated. That’s because even though screening has increased, health care providers still aren’t looking for the presence of the fungus as often as the CDC would like.
“The rapid rise and geographic spread of cases is concerning and emphasizes the need for continued surveillance, expanded lab capacity, quicker diagnostic tests, and adherence to proven infection prevention and control,” said study author Meghan Lyman, MD, a CDC epidemiologist in Atlanta, in a statement.
Cases of C. auris continued to rise in 2022, the CDC said. A map on the agency’s website of reported cases from 2022 shows it was found in more than half of U.S. states, with the highest counts occurring in California, Florida, Illinois, Nevada, New York, and Texas. The fungus is a problem worldwide and is listed among the most threatening treatment-resistant fungi by the World Health Organization.
The study authors concluded that screening capacity for the fungus needs to be expanded nationwide so that when C. auris is detected, measures can be taken to prevent its spread.
A version of this article originally appeared on WebMD.com.
prompting the Centers for Disease Control and Prevention to issue a warning to health care facilities about the rising threat.
C. auris is a yeast that spreads easily from touching it on a surface like a countertop. It can also spread from person to person. It isn’t a threat to healthy people, but people in hospitals and nursing homes are at a heightened risk because they might have weakened immune systems or be using invasive medical devices that can introduce the fungus inside their bodies. When C. auris progresses to causing an infection that reaches the brain, blood, or lungs, more than one in three people die.
The worrying increase was detailed in the journal Annals of Internal Medicine. In 2021, cases reached a count of 3,270 with an active infection, and 7,413 cases showed the fungus was present but hadn’t caused an infection. Infection counts were up 95% over the previous year, and the fungus showed up on screenings three times as often. The number of cases resistant to medication also tripled.
The CDC called the figures “alarming,” noting that the fungus was only detected in the United States in 2016.
“The timing of this increase and findings from public health investigations suggest C. auris spread may have worsened due to strain on health care and public health systems during the COVID-19 pandemic,” the CDC explained in a news release.
Another potential reason for the jump could be that screening for C. auris has simply increased and it’s being found more often because it’s being looked for more often. But researchers believe that, even with the increase in testing, the reported counts are underestimated. That’s because even though screening has increased, health care providers still aren’t looking for the presence of the fungus as often as the CDC would like.
“The rapid rise and geographic spread of cases is concerning and emphasizes the need for continued surveillance, expanded lab capacity, quicker diagnostic tests, and adherence to proven infection prevention and control,” said study author Meghan Lyman, MD, a CDC epidemiologist in Atlanta, in a statement.
Cases of C. auris continued to rise in 2022, the CDC said. A map on the agency’s website of reported cases from 2022 shows it was found in more than half of U.S. states, with the highest counts occurring in California, Florida, Illinois, Nevada, New York, and Texas. The fungus is a problem worldwide and is listed among the most threatening treatment-resistant fungi by the World Health Organization.
The study authors concluded that screening capacity for the fungus needs to be expanded nationwide so that when C. auris is detected, measures can be taken to prevent its spread.
A version of this article originally appeared on WebMD.com.
prompting the Centers for Disease Control and Prevention to issue a warning to health care facilities about the rising threat.
C. auris is a yeast that spreads easily from touching it on a surface like a countertop. It can also spread from person to person. It isn’t a threat to healthy people, but people in hospitals and nursing homes are at a heightened risk because they might have weakened immune systems or be using invasive medical devices that can introduce the fungus inside their bodies. When C. auris progresses to causing an infection that reaches the brain, blood, or lungs, more than one in three people die.
The worrying increase was detailed in the journal Annals of Internal Medicine. In 2021, cases reached a count of 3,270 with an active infection, and 7,413 cases showed the fungus was present but hadn’t caused an infection. Infection counts were up 95% over the previous year, and the fungus showed up on screenings three times as often. The number of cases resistant to medication also tripled.
The CDC called the figures “alarming,” noting that the fungus was only detected in the United States in 2016.
“The timing of this increase and findings from public health investigations suggest C. auris spread may have worsened due to strain on health care and public health systems during the COVID-19 pandemic,” the CDC explained in a news release.
Another potential reason for the jump could be that screening for C. auris has simply increased and it’s being found more often because it’s being looked for more often. But researchers believe that, even with the increase in testing, the reported counts are underestimated. That’s because even though screening has increased, health care providers still aren’t looking for the presence of the fungus as often as the CDC would like.
“The rapid rise and geographic spread of cases is concerning and emphasizes the need for continued surveillance, expanded lab capacity, quicker diagnostic tests, and adherence to proven infection prevention and control,” said study author Meghan Lyman, MD, a CDC epidemiologist in Atlanta, in a statement.
Cases of C. auris continued to rise in 2022, the CDC said. A map on the agency’s website of reported cases from 2022 shows it was found in more than half of U.S. states, with the highest counts occurring in California, Florida, Illinois, Nevada, New York, and Texas. The fungus is a problem worldwide and is listed among the most threatening treatment-resistant fungi by the World Health Organization.
The study authors concluded that screening capacity for the fungus needs to be expanded nationwide so that when C. auris is detected, measures can be taken to prevent its spread.
A version of this article originally appeared on WebMD.com.
HIV testing still suboptimal
from the Centers for Disease Control and Prevention. The reasons are complex and could jeopardize goals of ending the AIDS epidemic by 2030.
Patients and doctors alike face system challenges, including stigma, confidentiality concerns, racism, and inequitable access. Yet doctors, public health authorities, and even some patients agree that testing does work: In 2022, 81% of people diagnosed with HIV were linked to care within 30 days. Moreover, many patients are aware of where and how they wish to be tested. So, what would it take to achieve what ostensibly should be the lowest hanging fruit in the HIV care continuum?
“We didn’t look at the reasons for not testing,” Marc Pitasi, MPH, CDC epidemiologist and coauthor of the CDC study said in an interview. But “we found that the majority of people prefer the test in a clinical setting, so that’s a huge important piece of the puzzle,” he said.
The “never-tested” populations (4,334 of 6,072) in the study were predominantly aged 18-29 years (79.7%) and 50 years plus (78.1%). A total of 48% of never-tested adults also indicated that they had engaged in past-year risky behaviors (that is, injection drug use, treated for a sexually transmitted disease, exchanged sex/drugs for money, engaged in condomless anal sex, or had more than four sex partners). However, the difference between never-tested adults who live in EHE (Ending the HIV Epidemic in the U.S.)–designated jurisdictions (comprising 50 areas and 7 U.S. states responsible for more than 50% of new HIV infections) and those residing in non-EHE areas was only about 5 percentage points (69.1% vs. 74.5%, respectively), underscoring the need for broader engagement.
“There’s definitely a lack of testing across the board,” explained Lina Rosengren-Hovee, MD, MPH, MS, an infectious disease epidemiologist at the University of North Carolina at Chapel Hill. “There are all sorts of biases on how we make decisions and how we stratify … and these heuristics that we have in our minds to identify who is at risk and who needs testing,” she said.
“If we just look at the need for HIV testing based on who is at risk, I think that we are always going to fall short.”
Conflicting priorities
Seventeen years have passed since the CDC recommended that HIV testing and screening be offered at least once to all people aged 13-64 years in a routine clinical setting, with an opt-out option and without a separate written consent. People at higher risk (sexually active gay, bisexual, and other men who have sex with men) should be rescreened at least annually.
These recommendations were subsequently reinforced by numerous organizations, including the U.S. Preventive Services Task Force in 2013 and again in 2019, and the American Academy of Pediatrics in 2021.
But Dr. Rosengren-Hovee said that some clinicians remain unaware of the guidelines; for others, they’re usually not top-of-mind because of conflicting priorities.
This is especially true of pediatricians, who, despite data demonstrating that adolescents account for roughly 21% of new HIV diagnoses, rarely recognize or take advantage of HIV-testing opportunities during routine clinical visits.
“Pediatricians want to do the right thing for their patients but at the same time, they want to do the right thing on so many different fronts,” said Sarah Wood, MD, of the University of Pennsylvania, Philadelphia, and attending physician of adolescent medicine at Children’s Hospital of Philadelphia.
Dr. Wood is coauthor of a study published in Implementation Science Communicationsexamining pediatrician perspectives on implementing HIV testing and prevention. Participants identified confidentiality and time constraints as the most important challenges across every step of their workflow, which in turn, influenced perceptions about patients’ perceived risks for acquiring HIV – perceptions that Dr. Wood believes can be overcome.
“We need to really push pediatricians (through guideline-making societies like AAP and USPSTF) that screening should be universal and not linked to sexual activity or pinned to behavior, so the offer of testing is a universal opt-out,” she said. Additionally, “we need to make it easier for pediatricians to order the test,” for example, “through an office rapid test … and a redesigned workflow that moves the conversation away from physicians and nurse practitioners to medical assistants.”
Dr. Wood also pointed out that any effort would require pediatricians and other types of providers to overcome discomfort around sexual health conversations, noting that, while pediatricians are ideally positioned to work with parents to do education around sexual health, training and impetus are needed.
A fractured system
A fractured, often ill-funded U.S. health care system might also be at play according to Scott Harris, MD, MPH, state health officer of the Alabama Department of Public Health in Montgomery, and Association of State and Territorial Health Officials’ Infectious Disease Policy Committee chair.
“There’s a general consensus among everyone in public health that [HIV testing] is an important issue that we’re not addressing as well as we’d like to,” he said.
Dr. Harris acknowledged that, while COVID diverted attention away from HIV, some states have prioritized HIV more than others.
“We don’t have a national public health program; we have a nationwide public health program,” he said. “Everyone’s different and has different responsibilities and authorities ... depending on where their funding streams come from.”
The White House recently announced that it proposed a measure in its Fiscal Year 2023 budget to increase funding for HIV a further $313 million to accelerate efforts to end HIV by 2030, also adding a mandatory program to increase preexposure prophylaxis (PrEP) access. Without congressional approval, the measures are doomed to fail, leaving many states without the proper tools to enhance existing programs, and further painting overworked clinicians into a corner.
For patients, the ramifications are even greater.
“The majority of folks [in the CDC study] that were not tested said that if they were to get tested, they’d prefer to do that within the context of their primary care setting,” said Justin C. Smith, MS, MPH, director of the Campaign to End AIDS, Positive Impact Health Centers; a behavioral scientist at Emory University’s Rollins School of Public Health in Atlanta; and a member of the Presidential Advisory Council on HIV/AIDS.
“When you create a more responsive system that really speaks to the needs that people are expressing, that can provide better outcomes,” Dr. Smith said.
“It’s vital that we create health care and public health interventions that change the dynamics ... and make sure that we’re designing systems with the people that we’re trying to serve at the center.”
Mr. Pitasi, Dr. Rosengren-Hovee, Dr. Wood, Dr. Harris, and Dr. Smith have disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
from the Centers for Disease Control and Prevention. The reasons are complex and could jeopardize goals of ending the AIDS epidemic by 2030.
Patients and doctors alike face system challenges, including stigma, confidentiality concerns, racism, and inequitable access. Yet doctors, public health authorities, and even some patients agree that testing does work: In 2022, 81% of people diagnosed with HIV were linked to care within 30 days. Moreover, many patients are aware of where and how they wish to be tested. So, what would it take to achieve what ostensibly should be the lowest hanging fruit in the HIV care continuum?
“We didn’t look at the reasons for not testing,” Marc Pitasi, MPH, CDC epidemiologist and coauthor of the CDC study said in an interview. But “we found that the majority of people prefer the test in a clinical setting, so that’s a huge important piece of the puzzle,” he said.
The “never-tested” populations (4,334 of 6,072) in the study were predominantly aged 18-29 years (79.7%) and 50 years plus (78.1%). A total of 48% of never-tested adults also indicated that they had engaged in past-year risky behaviors (that is, injection drug use, treated for a sexually transmitted disease, exchanged sex/drugs for money, engaged in condomless anal sex, or had more than four sex partners). However, the difference between never-tested adults who live in EHE (Ending the HIV Epidemic in the U.S.)–designated jurisdictions (comprising 50 areas and 7 U.S. states responsible for more than 50% of new HIV infections) and those residing in non-EHE areas was only about 5 percentage points (69.1% vs. 74.5%, respectively), underscoring the need for broader engagement.
“There’s definitely a lack of testing across the board,” explained Lina Rosengren-Hovee, MD, MPH, MS, an infectious disease epidemiologist at the University of North Carolina at Chapel Hill. “There are all sorts of biases on how we make decisions and how we stratify … and these heuristics that we have in our minds to identify who is at risk and who needs testing,” she said.
“If we just look at the need for HIV testing based on who is at risk, I think that we are always going to fall short.”
Conflicting priorities
Seventeen years have passed since the CDC recommended that HIV testing and screening be offered at least once to all people aged 13-64 years in a routine clinical setting, with an opt-out option and without a separate written consent. People at higher risk (sexually active gay, bisexual, and other men who have sex with men) should be rescreened at least annually.
These recommendations were subsequently reinforced by numerous organizations, including the U.S. Preventive Services Task Force in 2013 and again in 2019, and the American Academy of Pediatrics in 2021.
But Dr. Rosengren-Hovee said that some clinicians remain unaware of the guidelines; for others, they’re usually not top-of-mind because of conflicting priorities.
This is especially true of pediatricians, who, despite data demonstrating that adolescents account for roughly 21% of new HIV diagnoses, rarely recognize or take advantage of HIV-testing opportunities during routine clinical visits.
“Pediatricians want to do the right thing for their patients but at the same time, they want to do the right thing on so many different fronts,” said Sarah Wood, MD, of the University of Pennsylvania, Philadelphia, and attending physician of adolescent medicine at Children’s Hospital of Philadelphia.
Dr. Wood is coauthor of a study published in Implementation Science Communicationsexamining pediatrician perspectives on implementing HIV testing and prevention. Participants identified confidentiality and time constraints as the most important challenges across every step of their workflow, which in turn, influenced perceptions about patients’ perceived risks for acquiring HIV – perceptions that Dr. Wood believes can be overcome.
“We need to really push pediatricians (through guideline-making societies like AAP and USPSTF) that screening should be universal and not linked to sexual activity or pinned to behavior, so the offer of testing is a universal opt-out,” she said. Additionally, “we need to make it easier for pediatricians to order the test,” for example, “through an office rapid test … and a redesigned workflow that moves the conversation away from physicians and nurse practitioners to medical assistants.”
Dr. Wood also pointed out that any effort would require pediatricians and other types of providers to overcome discomfort around sexual health conversations, noting that, while pediatricians are ideally positioned to work with parents to do education around sexual health, training and impetus are needed.
A fractured system
A fractured, often ill-funded U.S. health care system might also be at play according to Scott Harris, MD, MPH, state health officer of the Alabama Department of Public Health in Montgomery, and Association of State and Territorial Health Officials’ Infectious Disease Policy Committee chair.
“There’s a general consensus among everyone in public health that [HIV testing] is an important issue that we’re not addressing as well as we’d like to,” he said.
Dr. Harris acknowledged that, while COVID diverted attention away from HIV, some states have prioritized HIV more than others.
“We don’t have a national public health program; we have a nationwide public health program,” he said. “Everyone’s different and has different responsibilities and authorities ... depending on where their funding streams come from.”
The White House recently announced that it proposed a measure in its Fiscal Year 2023 budget to increase funding for HIV a further $313 million to accelerate efforts to end HIV by 2030, also adding a mandatory program to increase preexposure prophylaxis (PrEP) access. Without congressional approval, the measures are doomed to fail, leaving many states without the proper tools to enhance existing programs, and further painting overworked clinicians into a corner.
For patients, the ramifications are even greater.
“The majority of folks [in the CDC study] that were not tested said that if they were to get tested, they’d prefer to do that within the context of their primary care setting,” said Justin C. Smith, MS, MPH, director of the Campaign to End AIDS, Positive Impact Health Centers; a behavioral scientist at Emory University’s Rollins School of Public Health in Atlanta; and a member of the Presidential Advisory Council on HIV/AIDS.
“When you create a more responsive system that really speaks to the needs that people are expressing, that can provide better outcomes,” Dr. Smith said.
“It’s vital that we create health care and public health interventions that change the dynamics ... and make sure that we’re designing systems with the people that we’re trying to serve at the center.”
Mr. Pitasi, Dr. Rosengren-Hovee, Dr. Wood, Dr. Harris, and Dr. Smith have disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
from the Centers for Disease Control and Prevention. The reasons are complex and could jeopardize goals of ending the AIDS epidemic by 2030.
Patients and doctors alike face system challenges, including stigma, confidentiality concerns, racism, and inequitable access. Yet doctors, public health authorities, and even some patients agree that testing does work: In 2022, 81% of people diagnosed with HIV were linked to care within 30 days. Moreover, many patients are aware of where and how they wish to be tested. So, what would it take to achieve what ostensibly should be the lowest hanging fruit in the HIV care continuum?
“We didn’t look at the reasons for not testing,” Marc Pitasi, MPH, CDC epidemiologist and coauthor of the CDC study said in an interview. But “we found that the majority of people prefer the test in a clinical setting, so that’s a huge important piece of the puzzle,” he said.
The “never-tested” populations (4,334 of 6,072) in the study were predominantly aged 18-29 years (79.7%) and 50 years plus (78.1%). A total of 48% of never-tested adults also indicated that they had engaged in past-year risky behaviors (that is, injection drug use, treated for a sexually transmitted disease, exchanged sex/drugs for money, engaged in condomless anal sex, or had more than four sex partners). However, the difference between never-tested adults who live in EHE (Ending the HIV Epidemic in the U.S.)–designated jurisdictions (comprising 50 areas and 7 U.S. states responsible for more than 50% of new HIV infections) and those residing in non-EHE areas was only about 5 percentage points (69.1% vs. 74.5%, respectively), underscoring the need for broader engagement.
“There’s definitely a lack of testing across the board,” explained Lina Rosengren-Hovee, MD, MPH, MS, an infectious disease epidemiologist at the University of North Carolina at Chapel Hill. “There are all sorts of biases on how we make decisions and how we stratify … and these heuristics that we have in our minds to identify who is at risk and who needs testing,” she said.
“If we just look at the need for HIV testing based on who is at risk, I think that we are always going to fall short.”
Conflicting priorities
Seventeen years have passed since the CDC recommended that HIV testing and screening be offered at least once to all people aged 13-64 years in a routine clinical setting, with an opt-out option and without a separate written consent. People at higher risk (sexually active gay, bisexual, and other men who have sex with men) should be rescreened at least annually.
These recommendations were subsequently reinforced by numerous organizations, including the U.S. Preventive Services Task Force in 2013 and again in 2019, and the American Academy of Pediatrics in 2021.
But Dr. Rosengren-Hovee said that some clinicians remain unaware of the guidelines; for others, they’re usually not top-of-mind because of conflicting priorities.
This is especially true of pediatricians, who, despite data demonstrating that adolescents account for roughly 21% of new HIV diagnoses, rarely recognize or take advantage of HIV-testing opportunities during routine clinical visits.
“Pediatricians want to do the right thing for their patients but at the same time, they want to do the right thing on so many different fronts,” said Sarah Wood, MD, of the University of Pennsylvania, Philadelphia, and attending physician of adolescent medicine at Children’s Hospital of Philadelphia.
Dr. Wood is coauthor of a study published in Implementation Science Communicationsexamining pediatrician perspectives on implementing HIV testing and prevention. Participants identified confidentiality and time constraints as the most important challenges across every step of their workflow, which in turn, influenced perceptions about patients’ perceived risks for acquiring HIV – perceptions that Dr. Wood believes can be overcome.
“We need to really push pediatricians (through guideline-making societies like AAP and USPSTF) that screening should be universal and not linked to sexual activity or pinned to behavior, so the offer of testing is a universal opt-out,” she said. Additionally, “we need to make it easier for pediatricians to order the test,” for example, “through an office rapid test … and a redesigned workflow that moves the conversation away from physicians and nurse practitioners to medical assistants.”
Dr. Wood also pointed out that any effort would require pediatricians and other types of providers to overcome discomfort around sexual health conversations, noting that, while pediatricians are ideally positioned to work with parents to do education around sexual health, training and impetus are needed.
A fractured system
A fractured, often ill-funded U.S. health care system might also be at play according to Scott Harris, MD, MPH, state health officer of the Alabama Department of Public Health in Montgomery, and Association of State and Territorial Health Officials’ Infectious Disease Policy Committee chair.
“There’s a general consensus among everyone in public health that [HIV testing] is an important issue that we’re not addressing as well as we’d like to,” he said.
Dr. Harris acknowledged that, while COVID diverted attention away from HIV, some states have prioritized HIV more than others.
“We don’t have a national public health program; we have a nationwide public health program,” he said. “Everyone’s different and has different responsibilities and authorities ... depending on where their funding streams come from.”
The White House recently announced that it proposed a measure in its Fiscal Year 2023 budget to increase funding for HIV a further $313 million to accelerate efforts to end HIV by 2030, also adding a mandatory program to increase preexposure prophylaxis (PrEP) access. Without congressional approval, the measures are doomed to fail, leaving many states without the proper tools to enhance existing programs, and further painting overworked clinicians into a corner.
For patients, the ramifications are even greater.
“The majority of folks [in the CDC study] that were not tested said that if they were to get tested, they’d prefer to do that within the context of their primary care setting,” said Justin C. Smith, MS, MPH, director of the Campaign to End AIDS, Positive Impact Health Centers; a behavioral scientist at Emory University’s Rollins School of Public Health in Atlanta; and a member of the Presidential Advisory Council on HIV/AIDS.
“When you create a more responsive system that really speaks to the needs that people are expressing, that can provide better outcomes,” Dr. Smith said.
“It’s vital that we create health care and public health interventions that change the dynamics ... and make sure that we’re designing systems with the people that we’re trying to serve at the center.”
Mr. Pitasi, Dr. Rosengren-Hovee, Dr. Wood, Dr. Harris, and Dr. Smith have disclosed no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
Children and COVID: A look back as the fourth year begins
With 3 years of the COVID-19 experience now past, it’s safe to say that SARS-CoV-2 changed American society in ways that could not have been predicted when the first U.S. cases were reported in January of 2020.
Who would have guessed back then that not one but two vaccines would be developed, approved, and widely distributed before the end of the year? Or that those vaccines would be rejected by large segments of the population on ideological grounds? Could anyone have predicted in early 2020 that schools in 21 states would be forbidden by law to require COVID-19 vaccination in students?
Vaccination is generally considered to be an activity of childhood, but that practice has been turned upside down with COVID-19. Among Americans aged 65 years and older, 95% have received at least one dose of vaccine, versus 27.9% of children younger than 12 years old, according to the Centers for Disease Control and Prevention.
The vaccine situation for children mirrors that of the population as a whole. The oldest children have the highest vaccination rates, and the rates decline along with age: 72.0% of those aged 12-17 years have received at least one dose, compared with 39.8% of 5- to 11-year-olds, 10.5% of 2- to 4-year-olds, and 8.0% of children under age 2, the CDC said on its COVID Data Tracker.
The youngest children were, of course, the last ones to be eligible for the vaccine, but their uptake has been much slower since emergency use was authorized in June of 2022. In the nearly 9 months since then, 9.5% of children aged 4 and under have received at least one dose, versus 66% of children aged 12-15 years in the first 9 months (May 2021 to March 2022).
Altogether, a total of 31.7 million, or 43%, of all children under age 18 had received at least one dose of COVID-19 vaccine as of March 8, 2023, according to the most recent CDC data.
Incidence: Counting COVID
Vaccination and other prevention efforts have tried to stem the tide, but what has COVID actually done to children since the Trump administration declared a nationwide emergency on March 13, 2020?
- 16.6 million cases.
- 186,035 new hospital admissions.
- 2,122 deaths.
Even the proportion of total COVID cases in children, 17.2%, is less than might be expected, given their relatively undervaccinated status.
Seroprevalence estimates seem to support the undercounting of pediatric cases. A survey of commercial laboratories working with the CDC put the seroprevalance of SARS-CoV-2 antibodies in children at 96.3% as of late 2022, based on tests of almost 27,000 specimens performed over an 8-week period from mid-October to mid-December. That would put the number of infected children at 65.7 million children.
Since Omicron
There has not been another major COVID-19 surge since the winter of 2021-2022, when the weekly rate of new cases reached 1,900 per 100,000 population in children aged 16-17 years in early January 2022 – the highest seen among children of any of the CDC’s age groups (0-4, 5-11, 12-15, 16-17) during the entire pandemic. Since the Omicron surge, the highest weekly rate was 221 per 100,000 during the week of May 15-21, again in 16- to 17-year-olds, the CDC reports.
The widely anticipated surge of COVID in the fall and winter of 2022 and 2023 – the so-called “tripledemic” involving influenza and respiratory syncytial virus – did not occur, possibly because so many Americans were vaccinated or previously infected, experts suggested. New-case rates, emergency room visits, and hospitalizations in children have continued to drop as winter comes to a close, CDC data show.
With 3 years of the COVID-19 experience now past, it’s safe to say that SARS-CoV-2 changed American society in ways that could not have been predicted when the first U.S. cases were reported in January of 2020.
Who would have guessed back then that not one but two vaccines would be developed, approved, and widely distributed before the end of the year? Or that those vaccines would be rejected by large segments of the population on ideological grounds? Could anyone have predicted in early 2020 that schools in 21 states would be forbidden by law to require COVID-19 vaccination in students?
Vaccination is generally considered to be an activity of childhood, but that practice has been turned upside down with COVID-19. Among Americans aged 65 years and older, 95% have received at least one dose of vaccine, versus 27.9% of children younger than 12 years old, according to the Centers for Disease Control and Prevention.
The vaccine situation for children mirrors that of the population as a whole. The oldest children have the highest vaccination rates, and the rates decline along with age: 72.0% of those aged 12-17 years have received at least one dose, compared with 39.8% of 5- to 11-year-olds, 10.5% of 2- to 4-year-olds, and 8.0% of children under age 2, the CDC said on its COVID Data Tracker.
The youngest children were, of course, the last ones to be eligible for the vaccine, but their uptake has been much slower since emergency use was authorized in June of 2022. In the nearly 9 months since then, 9.5% of children aged 4 and under have received at least one dose, versus 66% of children aged 12-15 years in the first 9 months (May 2021 to March 2022).
Altogether, a total of 31.7 million, or 43%, of all children under age 18 had received at least one dose of COVID-19 vaccine as of March 8, 2023, according to the most recent CDC data.
Incidence: Counting COVID
Vaccination and other prevention efforts have tried to stem the tide, but what has COVID actually done to children since the Trump administration declared a nationwide emergency on March 13, 2020?
- 16.6 million cases.
- 186,035 new hospital admissions.
- 2,122 deaths.
Even the proportion of total COVID cases in children, 17.2%, is less than might be expected, given their relatively undervaccinated status.
Seroprevalence estimates seem to support the undercounting of pediatric cases. A survey of commercial laboratories working with the CDC put the seroprevalance of SARS-CoV-2 antibodies in children at 96.3% as of late 2022, based on tests of almost 27,000 specimens performed over an 8-week period from mid-October to mid-December. That would put the number of infected children at 65.7 million children.
Since Omicron
There has not been another major COVID-19 surge since the winter of 2021-2022, when the weekly rate of new cases reached 1,900 per 100,000 population in children aged 16-17 years in early January 2022 – the highest seen among children of any of the CDC’s age groups (0-4, 5-11, 12-15, 16-17) during the entire pandemic. Since the Omicron surge, the highest weekly rate was 221 per 100,000 during the week of May 15-21, again in 16- to 17-year-olds, the CDC reports.
The widely anticipated surge of COVID in the fall and winter of 2022 and 2023 – the so-called “tripledemic” involving influenza and respiratory syncytial virus – did not occur, possibly because so many Americans were vaccinated or previously infected, experts suggested. New-case rates, emergency room visits, and hospitalizations in children have continued to drop as winter comes to a close, CDC data show.
With 3 years of the COVID-19 experience now past, it’s safe to say that SARS-CoV-2 changed American society in ways that could not have been predicted when the first U.S. cases were reported in January of 2020.
Who would have guessed back then that not one but two vaccines would be developed, approved, and widely distributed before the end of the year? Or that those vaccines would be rejected by large segments of the population on ideological grounds? Could anyone have predicted in early 2020 that schools in 21 states would be forbidden by law to require COVID-19 vaccination in students?
Vaccination is generally considered to be an activity of childhood, but that practice has been turned upside down with COVID-19. Among Americans aged 65 years and older, 95% have received at least one dose of vaccine, versus 27.9% of children younger than 12 years old, according to the Centers for Disease Control and Prevention.
The vaccine situation for children mirrors that of the population as a whole. The oldest children have the highest vaccination rates, and the rates decline along with age: 72.0% of those aged 12-17 years have received at least one dose, compared with 39.8% of 5- to 11-year-olds, 10.5% of 2- to 4-year-olds, and 8.0% of children under age 2, the CDC said on its COVID Data Tracker.
The youngest children were, of course, the last ones to be eligible for the vaccine, but their uptake has been much slower since emergency use was authorized in June of 2022. In the nearly 9 months since then, 9.5% of children aged 4 and under have received at least one dose, versus 66% of children aged 12-15 years in the first 9 months (May 2021 to March 2022).
Altogether, a total of 31.7 million, or 43%, of all children under age 18 had received at least one dose of COVID-19 vaccine as of March 8, 2023, according to the most recent CDC data.
Incidence: Counting COVID
Vaccination and other prevention efforts have tried to stem the tide, but what has COVID actually done to children since the Trump administration declared a nationwide emergency on March 13, 2020?
- 16.6 million cases.
- 186,035 new hospital admissions.
- 2,122 deaths.
Even the proportion of total COVID cases in children, 17.2%, is less than might be expected, given their relatively undervaccinated status.
Seroprevalence estimates seem to support the undercounting of pediatric cases. A survey of commercial laboratories working with the CDC put the seroprevalance of SARS-CoV-2 antibodies in children at 96.3% as of late 2022, based on tests of almost 27,000 specimens performed over an 8-week period from mid-October to mid-December. That would put the number of infected children at 65.7 million children.
Since Omicron
There has not been another major COVID-19 surge since the winter of 2021-2022, when the weekly rate of new cases reached 1,900 per 100,000 population in children aged 16-17 years in early January 2022 – the highest seen among children of any of the CDC’s age groups (0-4, 5-11, 12-15, 16-17) during the entire pandemic. Since the Omicron surge, the highest weekly rate was 221 per 100,000 during the week of May 15-21, again in 16- to 17-year-olds, the CDC reports.
The widely anticipated surge of COVID in the fall and winter of 2022 and 2023 – the so-called “tripledemic” involving influenza and respiratory syncytial virus – did not occur, possibly because so many Americans were vaccinated or previously infected, experts suggested. New-case rates, emergency room visits, and hospitalizations in children have continued to drop as winter comes to a close, CDC data show.
FDA moves to stop the spread of illicit ‘tranq’ in the U.S.
The agency issued an import alert, which gives it the power to detain raw ingredients or bulk finished product if the shipments are suspected to be in violation of the law. Xylazine was first approved by the FDA in 1972 as a sedative and analgesic for use only in animals.
It is increasingly being detected and is usually mixed with fentanyl, cocaine, methamphetamine, and other illicit drugs. A January 2023 study by Nashville-based testing company Aegis Sciences found xylazine in 413 of about 60,000 urine samples and in 25 of 39 states that submitted tests. The vast majority of xylazine-positive samples also tested positive for fentanyl.
The FDA said it would continue to ensure the availability of xylazine for veterinary use, and the American Veterinary Medicine Association said in a statement that it “supports such efforts to combat illicit drug use.”
FDA Commissioner Robert M. Califf, MD, said in a statement that the agency “remains concerned about the increasing prevalence of xylazine mixed with illicit drugs, and this action is one part of broader efforts the agency is undertaking to address this issue.”
In November, the agency warned health care providers that because xylazine is not an opioid, the overdose reversal agent naloxone would not be effective. Xylazine acts as a central alpha-2-adrenergic receptor agonist in the brainstem, causing a rapid decrease in the release of norepinephrine and dopamine in the central nervous system. Its use can lead to central nervous system and respiratory depression, said the FDA.
Clinicians have scrambled to treat severe necrotic skin ulcerations that develop at injection sites.
Xylazine is relatively cheap and easy to access, said the Drug Enforcement Administration and Department of Justice in a November joint report. The drug is “readily available for purchase on other Internet sites in liquid and powder form, often with no association to the veterinary profession nor requirements to prove legitimate need,” said the Justice Department. A buyer can purchase xylazine powder online from Chinese suppliers for $6-$20 per kilogram, according to the report.
In 2021, xylazine-positive overdoses were highest in the South, which experienced a 1,127% increase from 2020, the Justice Department reported. The same year, there were 1,281 overdoses involving the substance in the Northeast and 351 in the Midwest.
There were just 34 overdoses involving xylazine in the West in 2021, but its use appears to be growing. The San Francisco Department of Public Health said it had detected low levels of xylazine in four people who died of overdoses in December and January.
“Identifying xylazine in San Francisco is concerning,” said the department in a statement, adding that it had not yet seen evidence of skin wounds in injection drug users in the city.
In late February, the Los Angeles County Department of Public Health issued a warning to first responders and health care professionals that xylazine had been detected in the area’s illicit drug supply.
The department said it will “work closely with other partners to understand the extent of the possible xylazine contamination in the illicit drug supply to increase awareness and education to the public.”
The FDA commissioner said the agency will coordinate with public health officials to more closely track xylazine.
“We will continue to use all tools at our disposal and partner with the Drug Enforcement Administration and other federal, state, local agencies, and stakeholders as appropriate to stem these illicit activities and protect public health,” said Dr. Califf.
A version of this article first appeared on Medscape.com.
The agency issued an import alert, which gives it the power to detain raw ingredients or bulk finished product if the shipments are suspected to be in violation of the law. Xylazine was first approved by the FDA in 1972 as a sedative and analgesic for use only in animals.
It is increasingly being detected and is usually mixed with fentanyl, cocaine, methamphetamine, and other illicit drugs. A January 2023 study by Nashville-based testing company Aegis Sciences found xylazine in 413 of about 60,000 urine samples and in 25 of 39 states that submitted tests. The vast majority of xylazine-positive samples also tested positive for fentanyl.
The FDA said it would continue to ensure the availability of xylazine for veterinary use, and the American Veterinary Medicine Association said in a statement that it “supports such efforts to combat illicit drug use.”
FDA Commissioner Robert M. Califf, MD, said in a statement that the agency “remains concerned about the increasing prevalence of xylazine mixed with illicit drugs, and this action is one part of broader efforts the agency is undertaking to address this issue.”
In November, the agency warned health care providers that because xylazine is not an opioid, the overdose reversal agent naloxone would not be effective. Xylazine acts as a central alpha-2-adrenergic receptor agonist in the brainstem, causing a rapid decrease in the release of norepinephrine and dopamine in the central nervous system. Its use can lead to central nervous system and respiratory depression, said the FDA.
Clinicians have scrambled to treat severe necrotic skin ulcerations that develop at injection sites.
Xylazine is relatively cheap and easy to access, said the Drug Enforcement Administration and Department of Justice in a November joint report. The drug is “readily available for purchase on other Internet sites in liquid and powder form, often with no association to the veterinary profession nor requirements to prove legitimate need,” said the Justice Department. A buyer can purchase xylazine powder online from Chinese suppliers for $6-$20 per kilogram, according to the report.
In 2021, xylazine-positive overdoses were highest in the South, which experienced a 1,127% increase from 2020, the Justice Department reported. The same year, there were 1,281 overdoses involving the substance in the Northeast and 351 in the Midwest.
There were just 34 overdoses involving xylazine in the West in 2021, but its use appears to be growing. The San Francisco Department of Public Health said it had detected low levels of xylazine in four people who died of overdoses in December and January.
“Identifying xylazine in San Francisco is concerning,” said the department in a statement, adding that it had not yet seen evidence of skin wounds in injection drug users in the city.
In late February, the Los Angeles County Department of Public Health issued a warning to first responders and health care professionals that xylazine had been detected in the area’s illicit drug supply.
The department said it will “work closely with other partners to understand the extent of the possible xylazine contamination in the illicit drug supply to increase awareness and education to the public.”
The FDA commissioner said the agency will coordinate with public health officials to more closely track xylazine.
“We will continue to use all tools at our disposal and partner with the Drug Enforcement Administration and other federal, state, local agencies, and stakeholders as appropriate to stem these illicit activities and protect public health,” said Dr. Califf.
A version of this article first appeared on Medscape.com.
The agency issued an import alert, which gives it the power to detain raw ingredients or bulk finished product if the shipments are suspected to be in violation of the law. Xylazine was first approved by the FDA in 1972 as a sedative and analgesic for use only in animals.
It is increasingly being detected and is usually mixed with fentanyl, cocaine, methamphetamine, and other illicit drugs. A January 2023 study by Nashville-based testing company Aegis Sciences found xylazine in 413 of about 60,000 urine samples and in 25 of 39 states that submitted tests. The vast majority of xylazine-positive samples also tested positive for fentanyl.
The FDA said it would continue to ensure the availability of xylazine for veterinary use, and the American Veterinary Medicine Association said in a statement that it “supports such efforts to combat illicit drug use.”
FDA Commissioner Robert M. Califf, MD, said in a statement that the agency “remains concerned about the increasing prevalence of xylazine mixed with illicit drugs, and this action is one part of broader efforts the agency is undertaking to address this issue.”
In November, the agency warned health care providers that because xylazine is not an opioid, the overdose reversal agent naloxone would not be effective. Xylazine acts as a central alpha-2-adrenergic receptor agonist in the brainstem, causing a rapid decrease in the release of norepinephrine and dopamine in the central nervous system. Its use can lead to central nervous system and respiratory depression, said the FDA.
Clinicians have scrambled to treat severe necrotic skin ulcerations that develop at injection sites.
Xylazine is relatively cheap and easy to access, said the Drug Enforcement Administration and Department of Justice in a November joint report. The drug is “readily available for purchase on other Internet sites in liquid and powder form, often with no association to the veterinary profession nor requirements to prove legitimate need,” said the Justice Department. A buyer can purchase xylazine powder online from Chinese suppliers for $6-$20 per kilogram, according to the report.
In 2021, xylazine-positive overdoses were highest in the South, which experienced a 1,127% increase from 2020, the Justice Department reported. The same year, there were 1,281 overdoses involving the substance in the Northeast and 351 in the Midwest.
There were just 34 overdoses involving xylazine in the West in 2021, but its use appears to be growing. The San Francisco Department of Public Health said it had detected low levels of xylazine in four people who died of overdoses in December and January.
“Identifying xylazine in San Francisco is concerning,” said the department in a statement, adding that it had not yet seen evidence of skin wounds in injection drug users in the city.
In late February, the Los Angeles County Department of Public Health issued a warning to first responders and health care professionals that xylazine had been detected in the area’s illicit drug supply.
The department said it will “work closely with other partners to understand the extent of the possible xylazine contamination in the illicit drug supply to increase awareness and education to the public.”
The FDA commissioner said the agency will coordinate with public health officials to more closely track xylazine.
“We will continue to use all tools at our disposal and partner with the Drug Enforcement Administration and other federal, state, local agencies, and stakeholders as appropriate to stem these illicit activities and protect public health,” said Dr. Califf.
A version of this article first appeared on Medscape.com.
FDA strengthens mammography regulations: Final rule
A final rule, updating the regulations issued under the Mammography Quality Standards Act of 1992, requires that mammography facilities notify patients about the density of their breasts, strengthens the FDA’s oversight of facilities, and provides guidance to help physicians better categorize and assess mammograms, according to a March 9 press release.
The rule requires implementation of the changes within 18 months.
According to the final rule document, the updates are “intended to improve the delivery of mammography services” in ways that reflect changes in mammography technology, quality standards, and the way results are categorized, reported, and communicated to patients and providers.
For instance, mammography reports must include an assessment of breast density to provide greater detail on the potential limitations of the mammogram results and allow patients and physicians to make more informed decisions, such as the possibility of additional imaging for women with dense breast tissue.
“Today’s action represents the agency’s broader commitment to support innovation to prevent, detect and treat cancer,” said Hilary Marston, MD, MPH, FDA’s chief medical officer, in the agency’s press release. The FDA remains “committed to advancing efforts to improve the health of women and strengthen the fight against breast cancer.”
A version of this article first appeared on Medscape.com.
A final rule, updating the regulations issued under the Mammography Quality Standards Act of 1992, requires that mammography facilities notify patients about the density of their breasts, strengthens the FDA’s oversight of facilities, and provides guidance to help physicians better categorize and assess mammograms, according to a March 9 press release.
The rule requires implementation of the changes within 18 months.
According to the final rule document, the updates are “intended to improve the delivery of mammography services” in ways that reflect changes in mammography technology, quality standards, and the way results are categorized, reported, and communicated to patients and providers.
For instance, mammography reports must include an assessment of breast density to provide greater detail on the potential limitations of the mammogram results and allow patients and physicians to make more informed decisions, such as the possibility of additional imaging for women with dense breast tissue.
“Today’s action represents the agency’s broader commitment to support innovation to prevent, detect and treat cancer,” said Hilary Marston, MD, MPH, FDA’s chief medical officer, in the agency’s press release. The FDA remains “committed to advancing efforts to improve the health of women and strengthen the fight against breast cancer.”
A version of this article first appeared on Medscape.com.
A final rule, updating the regulations issued under the Mammography Quality Standards Act of 1992, requires that mammography facilities notify patients about the density of their breasts, strengthens the FDA’s oversight of facilities, and provides guidance to help physicians better categorize and assess mammograms, according to a March 9 press release.
The rule requires implementation of the changes within 18 months.
According to the final rule document, the updates are “intended to improve the delivery of mammography services” in ways that reflect changes in mammography technology, quality standards, and the way results are categorized, reported, and communicated to patients and providers.
For instance, mammography reports must include an assessment of breast density to provide greater detail on the potential limitations of the mammogram results and allow patients and physicians to make more informed decisions, such as the possibility of additional imaging for women with dense breast tissue.
“Today’s action represents the agency’s broader commitment to support innovation to prevent, detect and treat cancer,” said Hilary Marston, MD, MPH, FDA’s chief medical officer, in the agency’s press release. The FDA remains “committed to advancing efforts to improve the health of women and strengthen the fight against breast cancer.”
A version of this article first appeared on Medscape.com.
FDA expands abemaciclib use in high-risk early breast cancer
Abemaciclib was previously approved for this group of high-risk patients with the requirement that they have a Ki-67 score of at least 20%. The new expansion removes the Ki-67 testing requirement, meaning more patients are now eligible to receive this drug. High-risk patients eligible for the CDK4/6 inhibitor can now be identified solely on the basis of nodal status, tumor size, and tumor grade.
The FDA’s decision to expand the approval was based on 4-year data from the phase 3 monarchE trial of adjuvant abemaciclib, which showed benefit in invasive disease-free survival beyond the 2-year treatment course.
At 4 years, 85.5% of patients remained recurrence free with abemaciclib plus endocrine therapy, compared with 78.6% who received endocrine therapy alone, an absolute difference in invasive disease-free survival of 6.9%.
“The initial Verzenio FDA approval in early breast cancer was practice changing and now, through this indication expansion, we have the potential to reduce the risk of breast cancer recurrence for many more patients, relying solely on commonly utilized clinicopathologic features to identify them,” Erika P. Hamilton, MD, an investigator on the monarchE clinical trial, said in a press release.
A version of this article first appeared on Medscape.com.
Abemaciclib was previously approved for this group of high-risk patients with the requirement that they have a Ki-67 score of at least 20%. The new expansion removes the Ki-67 testing requirement, meaning more patients are now eligible to receive this drug. High-risk patients eligible for the CDK4/6 inhibitor can now be identified solely on the basis of nodal status, tumor size, and tumor grade.
The FDA’s decision to expand the approval was based on 4-year data from the phase 3 monarchE trial of adjuvant abemaciclib, which showed benefit in invasive disease-free survival beyond the 2-year treatment course.
At 4 years, 85.5% of patients remained recurrence free with abemaciclib plus endocrine therapy, compared with 78.6% who received endocrine therapy alone, an absolute difference in invasive disease-free survival of 6.9%.
“The initial Verzenio FDA approval in early breast cancer was practice changing and now, through this indication expansion, we have the potential to reduce the risk of breast cancer recurrence for many more patients, relying solely on commonly utilized clinicopathologic features to identify them,” Erika P. Hamilton, MD, an investigator on the monarchE clinical trial, said in a press release.
A version of this article first appeared on Medscape.com.
Abemaciclib was previously approved for this group of high-risk patients with the requirement that they have a Ki-67 score of at least 20%. The new expansion removes the Ki-67 testing requirement, meaning more patients are now eligible to receive this drug. High-risk patients eligible for the CDK4/6 inhibitor can now be identified solely on the basis of nodal status, tumor size, and tumor grade.
The FDA’s decision to expand the approval was based on 4-year data from the phase 3 monarchE trial of adjuvant abemaciclib, which showed benefit in invasive disease-free survival beyond the 2-year treatment course.
At 4 years, 85.5% of patients remained recurrence free with abemaciclib plus endocrine therapy, compared with 78.6% who received endocrine therapy alone, an absolute difference in invasive disease-free survival of 6.9%.
“The initial Verzenio FDA approval in early breast cancer was practice changing and now, through this indication expansion, we have the potential to reduce the risk of breast cancer recurrence for many more patients, relying solely on commonly utilized clinicopathologic features to identify them,” Erika P. Hamilton, MD, an investigator on the monarchE clinical trial, said in a press release.
A version of this article first appeared on Medscape.com.
FDA approves first biologic treatment for polymyalgia rheumatica
The Food and Drug Administration approved sarilumab (Kevzara) on March 1 for the treatment of polymyalgia rheumatica (PMR) in adults who have had an inadequate response to corticosteroids or could not tolerate a corticosteroid taper, joint developers Sanofi and Regeneron announced. The drug is the first and only FDA-approved biologic treatment for this inflammatory rheumatic disease.
The FDA previously approved sarilumab, an interleukin-6 receptor antagonist, in May 2017 for the treatment of moderate to severe active rheumatoid arthritis in adults who do not respond well or have an intolerance to disease-modifying antirheumatic drugs (DMARDs), like methotrexate.
The FDA approval for this new indication was based on results from the multicenter, phase 3 SAPHYR trial in patients with corticosteroid-resistant, active PMR. In the randomized, double-blind, placebo-controlled study, 59 participants received 200 mg of sarilumab plus a 14-week taper of corticosteroid treatment and 58 participants received placebo every 2 weeks along with a 52-week taper of corticosteroid treatment.
After 1 year, 28% of sarilumab patients achieved sustained remission, compared with 10% of the placebo group (P = .0193). This news organization previously reported these trial results in November when they were presented at the 2022 annual meeting of the American College of Rheumatology.
The most common adverse events in the sarilumab group were neutropenia (15%), leukopenia (7%), constipation (7%), pruritic rash (5%), myalgia (7%), fatigue (5%), and injection-site pruritus (5%). Two patients had serious adverse reactions of neutropenia, which resolved after discontinuing treatment.
“Polymyalgia rheumatica can be an incapacitating disease, causing painful disease flares in multiple parts of the bodies that leave people fatigued and unable to fully perform everyday activities. Corticosteroids have been the primary treatment to date, but many patients do not adequately respond to steroids or cannot be tapered off steroids, which puts such patients at risk of complications from long-term steroid therapy,” George D. Yancopolous, MD, PhD, president and chief scientific officer at Regeneron, said in the announcement. “With the approval of Kevzara for polymyalgia rheumatica, patients now have an FDA-approved treatment to help offer relief from the disabling symptoms of this disease and long-term dependence on steroids.”
A version of this article originally appeared on Medscape.com.
The Food and Drug Administration approved sarilumab (Kevzara) on March 1 for the treatment of polymyalgia rheumatica (PMR) in adults who have had an inadequate response to corticosteroids or could not tolerate a corticosteroid taper, joint developers Sanofi and Regeneron announced. The drug is the first and only FDA-approved biologic treatment for this inflammatory rheumatic disease.
The FDA previously approved sarilumab, an interleukin-6 receptor antagonist, in May 2017 for the treatment of moderate to severe active rheumatoid arthritis in adults who do not respond well or have an intolerance to disease-modifying antirheumatic drugs (DMARDs), like methotrexate.
The FDA approval for this new indication was based on results from the multicenter, phase 3 SAPHYR trial in patients with corticosteroid-resistant, active PMR. In the randomized, double-blind, placebo-controlled study, 59 participants received 200 mg of sarilumab plus a 14-week taper of corticosteroid treatment and 58 participants received placebo every 2 weeks along with a 52-week taper of corticosteroid treatment.
After 1 year, 28% of sarilumab patients achieved sustained remission, compared with 10% of the placebo group (P = .0193). This news organization previously reported these trial results in November when they were presented at the 2022 annual meeting of the American College of Rheumatology.
The most common adverse events in the sarilumab group were neutropenia (15%), leukopenia (7%), constipation (7%), pruritic rash (5%), myalgia (7%), fatigue (5%), and injection-site pruritus (5%). Two patients had serious adverse reactions of neutropenia, which resolved after discontinuing treatment.
“Polymyalgia rheumatica can be an incapacitating disease, causing painful disease flares in multiple parts of the bodies that leave people fatigued and unable to fully perform everyday activities. Corticosteroids have been the primary treatment to date, but many patients do not adequately respond to steroids or cannot be tapered off steroids, which puts such patients at risk of complications from long-term steroid therapy,” George D. Yancopolous, MD, PhD, president and chief scientific officer at Regeneron, said in the announcement. “With the approval of Kevzara for polymyalgia rheumatica, patients now have an FDA-approved treatment to help offer relief from the disabling symptoms of this disease and long-term dependence on steroids.”
A version of this article originally appeared on Medscape.com.
The Food and Drug Administration approved sarilumab (Kevzara) on March 1 for the treatment of polymyalgia rheumatica (PMR) in adults who have had an inadequate response to corticosteroids or could not tolerate a corticosteroid taper, joint developers Sanofi and Regeneron announced. The drug is the first and only FDA-approved biologic treatment for this inflammatory rheumatic disease.
The FDA previously approved sarilumab, an interleukin-6 receptor antagonist, in May 2017 for the treatment of moderate to severe active rheumatoid arthritis in adults who do not respond well or have an intolerance to disease-modifying antirheumatic drugs (DMARDs), like methotrexate.
The FDA approval for this new indication was based on results from the multicenter, phase 3 SAPHYR trial in patients with corticosteroid-resistant, active PMR. In the randomized, double-blind, placebo-controlled study, 59 participants received 200 mg of sarilumab plus a 14-week taper of corticosteroid treatment and 58 participants received placebo every 2 weeks along with a 52-week taper of corticosteroid treatment.
After 1 year, 28% of sarilumab patients achieved sustained remission, compared with 10% of the placebo group (P = .0193). This news organization previously reported these trial results in November when they were presented at the 2022 annual meeting of the American College of Rheumatology.
The most common adverse events in the sarilumab group were neutropenia (15%), leukopenia (7%), constipation (7%), pruritic rash (5%), myalgia (7%), fatigue (5%), and injection-site pruritus (5%). Two patients had serious adverse reactions of neutropenia, which resolved after discontinuing treatment.
“Polymyalgia rheumatica can be an incapacitating disease, causing painful disease flares in multiple parts of the bodies that leave people fatigued and unable to fully perform everyday activities. Corticosteroids have been the primary treatment to date, but many patients do not adequately respond to steroids or cannot be tapered off steroids, which puts such patients at risk of complications from long-term steroid therapy,” George D. Yancopolous, MD, PhD, president and chief scientific officer at Regeneron, said in the announcement. “With the approval of Kevzara for polymyalgia rheumatica, patients now have an FDA-approved treatment to help offer relief from the disabling symptoms of this disease and long-term dependence on steroids.”
A version of this article originally appeared on Medscape.com.
Drug-resistant stomach bug infections on the rise: CDC
The CDC issued the warning Feb. 24 about the rise in the problematic infections. Most of them have been seen in men who have sex with men, but a small number have also occurred in women and in young children.
The bacteria can be spread in a variety of ways, including changing the diaper of an infected baby, touching your mouth when the bacteria are on your hands, eating or drinking contaminated food or water, or through sexual contact. It’s easily transmitted because just a tiny amount of the bacteria is enough to make someone sick.
Shigella infection causes diarrhea that can be bloody. Other symptoms are a fever, belly cramping, and the feeling that you have to poop but your bowels are already empty. Most people recover on their own with rest and fluids, and severe cases can need antibiotic treatment. But strains of the bacteria that are resistant to treatment are on the rise.
Between 2015 and 2022, cases of antibiotic-resistant Shigella infection rose from 0% to 5% of all Shigella cases in the United States. One analysis showed that 82% of cases were in men, 13% in women, and 5% in children. A small sample of affected people provided information about their sexual activity, and 88% of them reported male-to-male sexual contact.
People at increased risk of infections are young children, people who are homeless, international travelers, people who have weakened immune systems, people living with HIV, and men who have sex with men.
The CDC asked health care workers to be on the lookout for these infections and report them.
A version of this article first appeared on WebMD.com.
The CDC issued the warning Feb. 24 about the rise in the problematic infections. Most of them have been seen in men who have sex with men, but a small number have also occurred in women and in young children.
The bacteria can be spread in a variety of ways, including changing the diaper of an infected baby, touching your mouth when the bacteria are on your hands, eating or drinking contaminated food or water, or through sexual contact. It’s easily transmitted because just a tiny amount of the bacteria is enough to make someone sick.
Shigella infection causes diarrhea that can be bloody. Other symptoms are a fever, belly cramping, and the feeling that you have to poop but your bowels are already empty. Most people recover on their own with rest and fluids, and severe cases can need antibiotic treatment. But strains of the bacteria that are resistant to treatment are on the rise.
Between 2015 and 2022, cases of antibiotic-resistant Shigella infection rose from 0% to 5% of all Shigella cases in the United States. One analysis showed that 82% of cases were in men, 13% in women, and 5% in children. A small sample of affected people provided information about their sexual activity, and 88% of them reported male-to-male sexual contact.
People at increased risk of infections are young children, people who are homeless, international travelers, people who have weakened immune systems, people living with HIV, and men who have sex with men.
The CDC asked health care workers to be on the lookout for these infections and report them.
A version of this article first appeared on WebMD.com.
The CDC issued the warning Feb. 24 about the rise in the problematic infections. Most of them have been seen in men who have sex with men, but a small number have also occurred in women and in young children.
The bacteria can be spread in a variety of ways, including changing the diaper of an infected baby, touching your mouth when the bacteria are on your hands, eating or drinking contaminated food or water, or through sexual contact. It’s easily transmitted because just a tiny amount of the bacteria is enough to make someone sick.
Shigella infection causes diarrhea that can be bloody. Other symptoms are a fever, belly cramping, and the feeling that you have to poop but your bowels are already empty. Most people recover on their own with rest and fluids, and severe cases can need antibiotic treatment. But strains of the bacteria that are resistant to treatment are on the rise.
Between 2015 and 2022, cases of antibiotic-resistant Shigella infection rose from 0% to 5% of all Shigella cases in the United States. One analysis showed that 82% of cases were in men, 13% in women, and 5% in children. A small sample of affected people provided information about their sexual activity, and 88% of them reported male-to-male sexual contact.
People at increased risk of infections are young children, people who are homeless, international travelers, people who have weakened immune systems, people living with HIV, and men who have sex with men.
The CDC asked health care workers to be on the lookout for these infections and report them.
A version of this article first appeared on WebMD.com.
FDA broadens warning on potentially contaminated eye products
The announcement released Wednesday adds to a previous warning issued earlier this month for EzriCare Artificial Tears or Delsam Pharma’s Artificial Tears because of potential bacterial contamination. All three products are manufactured by the same company, Global Pharma Healthcare, based in Tamilnadu, India.
The FDA has faulted the company for multiple violations, including “lack of appropriate microbial testing” and “lack of proper controls concerning tamper-evident packaging,” and has banned imports to the United States.
The updated warning from the FDA did not give additional information about the over-the-counter eye ointment beyond potential bacterial contamination.
On Feb. 1, the CDC issued an alert about an outbreak of a drug-resistant strain of bacteria, Pseudomonas aeruginosa, linked to artificial tear products. To date, 58 patients across 13 states have been identified, and the most commonly reported artificial tear brand was EzriCare Artificial Tears. Five patients had permanent vision loss, and one patient died.
A version of this article first appeared on Medscape.com.
The announcement released Wednesday adds to a previous warning issued earlier this month for EzriCare Artificial Tears or Delsam Pharma’s Artificial Tears because of potential bacterial contamination. All three products are manufactured by the same company, Global Pharma Healthcare, based in Tamilnadu, India.
The FDA has faulted the company for multiple violations, including “lack of appropriate microbial testing” and “lack of proper controls concerning tamper-evident packaging,” and has banned imports to the United States.
The updated warning from the FDA did not give additional information about the over-the-counter eye ointment beyond potential bacterial contamination.
On Feb. 1, the CDC issued an alert about an outbreak of a drug-resistant strain of bacteria, Pseudomonas aeruginosa, linked to artificial tear products. To date, 58 patients across 13 states have been identified, and the most commonly reported artificial tear brand was EzriCare Artificial Tears. Five patients had permanent vision loss, and one patient died.
A version of this article first appeared on Medscape.com.
The announcement released Wednesday adds to a previous warning issued earlier this month for EzriCare Artificial Tears or Delsam Pharma’s Artificial Tears because of potential bacterial contamination. All three products are manufactured by the same company, Global Pharma Healthcare, based in Tamilnadu, India.
The FDA has faulted the company for multiple violations, including “lack of appropriate microbial testing” and “lack of proper controls concerning tamper-evident packaging,” and has banned imports to the United States.
The updated warning from the FDA did not give additional information about the over-the-counter eye ointment beyond potential bacterial contamination.
On Feb. 1, the CDC issued an alert about an outbreak of a drug-resistant strain of bacteria, Pseudomonas aeruginosa, linked to artificial tear products. To date, 58 patients across 13 states have been identified, and the most commonly reported artificial tear brand was EzriCare Artificial Tears. Five patients had permanent vision loss, and one patient died.
A version of this article first appeared on Medscape.com.