User login
Bringing you the latest news, research and reviews, exclusive interviews, podcasts, quizzes, and more.
div[contains(@class, 'header__large-screen')]
div[contains(@class, 'read-next-article')]
div[contains(@class, 'main-prefix')]
div[contains(@class, 'nav-primary')]
nav[contains(@class, 'nav-primary')]
section[contains(@class, 'footer-nav-section-wrapper')]
footer[@id='footer']
section[contains(@class, 'nav-hidden')]
div[contains(@class, 'ce-card-content')]
nav[contains(@class, 'nav-ce-stack')]
div[contains(@class, 'view-medstat-quiz-listing-panes')]
div[contains(@class, 'pane-article-sidebar-latest-news')]
div[contains(@class, 'medstat-accordion-set article-series')]
Ivermectin doesn’t help treat COVID-19, large study finds
according to results from a large clinical trial published in the New England Journal of Medicine.
The findings pretty much rule out the drug as a treatment for COVID-19, the study authors wrote.
“There’s really no sign of any benefit,” David Boulware, MD, one of the coauthors and an infectious disease specialist at the University of Minnesota, Minneapolis, told the New York Times.
The researchers shared a summary of the results in August 2021 during an online presentation hosted by the National Institutes of Health. The full data hadn’t been published until now.
“Now that people can dive into the details and the data, hopefully that will steer the majority of doctors away from ivermectin toward other therapies,” Dr. Boulware said.
In the trial, the research team compared more than 1,350 people infected with the coronavirus in Brazil who received either ivermectin or a placebo as treatment.
Between March and August 2021, 679 patients received a daily dose of ivermectin over the course of 3 days. The researchers found that ivermectin didn’t reduce the risk that people with COVID-19 would be hospitalized or go to an ED within 28 days after treatment.
In addition, the researchers looked at particular groups to understand if some patients benefited for some reason, such as taking ivermectin sooner after testing positive for COVID-19. But those who took the drug during the first 3 days after a positive coronavirus test ended up doing worse than those in the placebo group. The drug also didn’t help patients recover sooner.
The researchers found “no important effects” of treatment with ivermectin on the number of days people spent in the hospital, the number of days hospitalized people needed mechanical ventilation, or the risk of death.
Ivermectin has become a controversial focal point during the pandemic.
For decades, the drug has been widely used to treat parasitic infections. At the beginning of the pandemic, researchers checked thousands of existing drugs against the coronavirus to determine if a potential treatment already existed. Laboratory experiments on cells suggested that ivermectin might work, the New York Times reported.
But some researchers noted that the experiments worked because a high concentration of ivermectin was used, a much higher dose than would be safe for people. Despite the concerns, some doctors began prescribing ivermectin to patients. After receiving reports of people who needed medical attention, particularly after using formulations intended for livestock, the Food and Drug Administration issued a warning that the drug wasn’t approved to be used for COVID-19.
Researchers around the world have done small clinical trials to understand whether ivermectin treats COVID-19, the newspaper reported. At the end of 2020, Andrew Hill, MD, a virologist at the University of Liverpool in England, reviewed the results from 23 trials and concluded that the drug could lower the risk of death from COVID-19. He published the results in July 2021, but later reports found that many of the studies were flawed, and at least one was fraudulent.
Dr. Hill retracted his original study and began another analysis, which was published in January 2022. In this review, he and his colleagues focused on studies that were least likely to be biased. They found that ivermectin was not helpful.
Recently, Dr. Hill and associates ran another analysis using the new data from the Brazil trial, and once again they saw no benefit.
Several clinical trials are still testing ivermectin as a treatment, the New York Times reported, with results expected in upcoming months. After reviewing the data from the Brazil trial, which tested ivermectin and a variety of other drugs against COVID-19, some infectious disease experts say they’ll likely see more of the same – that ivermectin doesn’t help people with COVID-19.
“I welcome the results of the other clinical trials and will view them with an open mind,” Paul Sax, MD, an infectious disease expert at Brigham and Women’s Hospital, Boston, who has been watching the data on the drug throughout the pandemic, told the New York Times.
“But at some point, it will become a waste of resources to continue studying an unpromising approach,” he said.
A version of this article first appeared on WebMD.com.
according to results from a large clinical trial published in the New England Journal of Medicine.
The findings pretty much rule out the drug as a treatment for COVID-19, the study authors wrote.
“There’s really no sign of any benefit,” David Boulware, MD, one of the coauthors and an infectious disease specialist at the University of Minnesota, Minneapolis, told the New York Times.
The researchers shared a summary of the results in August 2021 during an online presentation hosted by the National Institutes of Health. The full data hadn’t been published until now.
“Now that people can dive into the details and the data, hopefully that will steer the majority of doctors away from ivermectin toward other therapies,” Dr. Boulware said.
In the trial, the research team compared more than 1,350 people infected with the coronavirus in Brazil who received either ivermectin or a placebo as treatment.
Between March and August 2021, 679 patients received a daily dose of ivermectin over the course of 3 days. The researchers found that ivermectin didn’t reduce the risk that people with COVID-19 would be hospitalized or go to an ED within 28 days after treatment.
In addition, the researchers looked at particular groups to understand if some patients benefited for some reason, such as taking ivermectin sooner after testing positive for COVID-19. But those who took the drug during the first 3 days after a positive coronavirus test ended up doing worse than those in the placebo group. The drug also didn’t help patients recover sooner.
The researchers found “no important effects” of treatment with ivermectin on the number of days people spent in the hospital, the number of days hospitalized people needed mechanical ventilation, or the risk of death.
Ivermectin has become a controversial focal point during the pandemic.
For decades, the drug has been widely used to treat parasitic infections. At the beginning of the pandemic, researchers checked thousands of existing drugs against the coronavirus to determine if a potential treatment already existed. Laboratory experiments on cells suggested that ivermectin might work, the New York Times reported.
But some researchers noted that the experiments worked because a high concentration of ivermectin was used, a much higher dose than would be safe for people. Despite the concerns, some doctors began prescribing ivermectin to patients. After receiving reports of people who needed medical attention, particularly after using formulations intended for livestock, the Food and Drug Administration issued a warning that the drug wasn’t approved to be used for COVID-19.
Researchers around the world have done small clinical trials to understand whether ivermectin treats COVID-19, the newspaper reported. At the end of 2020, Andrew Hill, MD, a virologist at the University of Liverpool in England, reviewed the results from 23 trials and concluded that the drug could lower the risk of death from COVID-19. He published the results in July 2021, but later reports found that many of the studies were flawed, and at least one was fraudulent.
Dr. Hill retracted his original study and began another analysis, which was published in January 2022. In this review, he and his colleagues focused on studies that were least likely to be biased. They found that ivermectin was not helpful.
Recently, Dr. Hill and associates ran another analysis using the new data from the Brazil trial, and once again they saw no benefit.
Several clinical trials are still testing ivermectin as a treatment, the New York Times reported, with results expected in upcoming months. After reviewing the data from the Brazil trial, which tested ivermectin and a variety of other drugs against COVID-19, some infectious disease experts say they’ll likely see more of the same – that ivermectin doesn’t help people with COVID-19.
“I welcome the results of the other clinical trials and will view them with an open mind,” Paul Sax, MD, an infectious disease expert at Brigham and Women’s Hospital, Boston, who has been watching the data on the drug throughout the pandemic, told the New York Times.
“But at some point, it will become a waste of resources to continue studying an unpromising approach,” he said.
A version of this article first appeared on WebMD.com.
according to results from a large clinical trial published in the New England Journal of Medicine.
The findings pretty much rule out the drug as a treatment for COVID-19, the study authors wrote.
“There’s really no sign of any benefit,” David Boulware, MD, one of the coauthors and an infectious disease specialist at the University of Minnesota, Minneapolis, told the New York Times.
The researchers shared a summary of the results in August 2021 during an online presentation hosted by the National Institutes of Health. The full data hadn’t been published until now.
“Now that people can dive into the details and the data, hopefully that will steer the majority of doctors away from ivermectin toward other therapies,” Dr. Boulware said.
In the trial, the research team compared more than 1,350 people infected with the coronavirus in Brazil who received either ivermectin or a placebo as treatment.
Between March and August 2021, 679 patients received a daily dose of ivermectin over the course of 3 days. The researchers found that ivermectin didn’t reduce the risk that people with COVID-19 would be hospitalized or go to an ED within 28 days after treatment.
In addition, the researchers looked at particular groups to understand if some patients benefited for some reason, such as taking ivermectin sooner after testing positive for COVID-19. But those who took the drug during the first 3 days after a positive coronavirus test ended up doing worse than those in the placebo group. The drug also didn’t help patients recover sooner.
The researchers found “no important effects” of treatment with ivermectin on the number of days people spent in the hospital, the number of days hospitalized people needed mechanical ventilation, or the risk of death.
Ivermectin has become a controversial focal point during the pandemic.
For decades, the drug has been widely used to treat parasitic infections. At the beginning of the pandemic, researchers checked thousands of existing drugs against the coronavirus to determine if a potential treatment already existed. Laboratory experiments on cells suggested that ivermectin might work, the New York Times reported.
But some researchers noted that the experiments worked because a high concentration of ivermectin was used, a much higher dose than would be safe for people. Despite the concerns, some doctors began prescribing ivermectin to patients. After receiving reports of people who needed medical attention, particularly after using formulations intended for livestock, the Food and Drug Administration issued a warning that the drug wasn’t approved to be used for COVID-19.
Researchers around the world have done small clinical trials to understand whether ivermectin treats COVID-19, the newspaper reported. At the end of 2020, Andrew Hill, MD, a virologist at the University of Liverpool in England, reviewed the results from 23 trials and concluded that the drug could lower the risk of death from COVID-19. He published the results in July 2021, but later reports found that many of the studies were flawed, and at least one was fraudulent.
Dr. Hill retracted his original study and began another analysis, which was published in January 2022. In this review, he and his colleagues focused on studies that were least likely to be biased. They found that ivermectin was not helpful.
Recently, Dr. Hill and associates ran another analysis using the new data from the Brazil trial, and once again they saw no benefit.
Several clinical trials are still testing ivermectin as a treatment, the New York Times reported, with results expected in upcoming months. After reviewing the data from the Brazil trial, which tested ivermectin and a variety of other drugs against COVID-19, some infectious disease experts say they’ll likely see more of the same – that ivermectin doesn’t help people with COVID-19.
“I welcome the results of the other clinical trials and will view them with an open mind,” Paul Sax, MD, an infectious disease expert at Brigham and Women’s Hospital, Boston, who has been watching the data on the drug throughout the pandemic, told the New York Times.
“But at some point, it will become a waste of resources to continue studying an unpromising approach,” he said.
A version of this article first appeared on WebMD.com.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
Skin reactions to first COVID-19 vaccine don’t justify forgoing second dose
BOSTON – Requests for a according to an analysis of several large sets of data presented at the annual meeting of the American Academy of Dermatology.
According to the data, “there are no serious adverse consequences from these cutaneous reactions,” said Esther Freeman, MD, PhD, director of Global Health Dermatology, Massachusetts General Hospital, Boston.
This is important because the risk of vaccine hesitancy goes up dramatically in patients who experience reactions to the first vaccine dose, according to follow-up of more than 50,000 employees vaccinated in the Mass General Brigham Healthcare System (MGBHS). According to Dr. Freeman, there was almost a fourfold increase in the rate of second-dose refusals for those with cutaneous reactions and a more than fourfold increase in those who developed angioedema.
Before the data were available, skin reactions were a source of concern among dermatologists and others involved in monitoring vaccine-related adverse events. Injection site reactions (ISRs) are associated with essentially every injectable vaccine, so these were expected, but a small proportion of patients developed large red plaques in the injection arm 7-8 days after the inoculation.
“These delayed reactions caused a lot of initial panic,” said Dr. Freeman, who counted herself among those alarmed about what the reactions might signify. “Was this cellulitis? Would the next dose cause anaphylaxis? We were concerned.”
This concern dissipated with the availability of more data. In a global registry that has so far captured more than 1,000 cutaneous reactions from 52 participating countries, it appears that about 2% of patients have a cutaneous reaction other than an ISR after the first dose. All resolve with minimal skin care or no treatment.
After the second dose, the proportion is lower. If there is a reaction, it typically occurs earlier and resolves more quickly.
“What we have learned is that fewer than half of patients who had a reaction to the first dose have a reaction to the second, and those who did have a reaction had a milder course,” said Dr. Freeman.
These data are “incredibly reassuring” on many levels, she explained. In addition, it allows clinicians to confidently explain to patients that there are no serious sequelae from the rashes, whether immediate or delayed, from the available COVID-19 vaccines.
“Every skin reaction I have seen is something we can treat through,” she added, noting that most reactions resolve with little or no supportive care. Following skin reactions, particularly the delayed lesions, it is not uncommon for patients to refuse a second shot. Some request a medical waiver to avoid further vaccine exposure. According to Dr. Freeman, this is unwarranted.
“I have granted exactly zero waivers,” she said. She explains to patients that these reactions have not been predictive of serious events, such as anaphylaxis. Although the trigger of the hypersensitivity reaction remains unknown, there is no evidence of serious consequences.
Delayed skin reactions are more commonly associated with the Moderna than the Pfizer vaccine. One notable difference between these vaccines is the greater content of mRNA in the Moderna formulation, but Freeman said that this is only one potential hypothesis for higher frequency of reactions to this version of the vaccine.
Patients with a history of allergic disease are more likely to develop a reaction but not significantly more likely to have a reaction that is more difficult to manage, according to Kimberly G. Blumenthal, MD, quality and safety officer for allergy, and codirector of the clinical epidemiology program in the division of rheumatology, allergy, and immunology at Mass General.
Anaphylaxis has been associated with COVD-19 vaccines just as it has with essentially every injectable vaccine, Dr. Blumenthal said during the same session. But the risk is very low, and it stays low even among those with a history of severe hypersensitivity reactions in the past.
Among the data collected from more than 52,000 vaccinated MGBHS employees, 0.9% had a history of severe allergic reaction to a prior vaccine. Of these, 11.6% had an allergic reaction to the COVID-19 vaccine. This was more than twice the 4.6% rate of allergic reactions among employees without a history of allergic reactions, but serious consequences were rare in both groups.
Of those with a reaction to the first dose, all but 2.4% took a subsequent dose. Again, serious reactions were exceedingly rare. These serious reactions did include anaphylaxis and hospitalization in 3% of patients, but there were no fatalities and all resolved.
The absence of serious sequelae from a reaction to a COVID-19 vaccine must be considered within the context of the benefit, which includes protection from death and hospitalization from the virus, according to Dr. Blumenthal. Citing the evidence that first-shot reactions are a source of vaccine hesitancy, she agreed that it is important to educate patients about relative risks.
“Even in our own cohort of MGBHS employees, we have people, including those who had been provaccine in the past, become hesitant,” commented Dr. Blumenthal, who said there are data from the Kaiser Permanente System showing similar vaccine reluctance following a first-shot reaction.
After more than 500 million doses of the Moderna and Pfizer vaccines had been administered worldwide, there was not a single reported death from anaphylaxis. Although Dr. Blumenthal said that an unconfirmed death of this type had been recently reported, she emphasized that this single death, if valid, is dwarfed by the lives saved with vaccination.
Asked about her strategy for counseling patients with vaccine hesitancy, Dr. Freeman said the body of safety data is large and compelling. There is overwhelming evidence of a favorable benefit-to-risk ratio overall and among those with a first-shot reaction.
“I can reassure them on the basis of the data,” Dr. Freeman said in an interview. “Less than half will have a reaction to the second shot and even if they do have a reaction, it is likely to be less severe.”
Although the main message is that vaccination is potentially lifesaving and far outweighs any risks, Freeman specifically gives this message to those hesitant to take a second shot after a first-shot reaction: “I can get you through it.”
Dr. Freeman encouraged health care professionals to report cases of COVID-19 vaccine–related dermatologic side effects to the American Academy of Dermatology / International League of Dermatologic Societies COVID-19 dermatology registry. Dermatologic manifestations of COVID-19 can also be reported to the registry.
Dr. Freeman disclosed receiving grants/research funding from the International League of Dermatologic Societies and from the National Institutes of Health. Dr. Blumenthal disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
BOSTON – Requests for a according to an analysis of several large sets of data presented at the annual meeting of the American Academy of Dermatology.
According to the data, “there are no serious adverse consequences from these cutaneous reactions,” said Esther Freeman, MD, PhD, director of Global Health Dermatology, Massachusetts General Hospital, Boston.
This is important because the risk of vaccine hesitancy goes up dramatically in patients who experience reactions to the first vaccine dose, according to follow-up of more than 50,000 employees vaccinated in the Mass General Brigham Healthcare System (MGBHS). According to Dr. Freeman, there was almost a fourfold increase in the rate of second-dose refusals for those with cutaneous reactions and a more than fourfold increase in those who developed angioedema.
Before the data were available, skin reactions were a source of concern among dermatologists and others involved in monitoring vaccine-related adverse events. Injection site reactions (ISRs) are associated with essentially every injectable vaccine, so these were expected, but a small proportion of patients developed large red plaques in the injection arm 7-8 days after the inoculation.
“These delayed reactions caused a lot of initial panic,” said Dr. Freeman, who counted herself among those alarmed about what the reactions might signify. “Was this cellulitis? Would the next dose cause anaphylaxis? We were concerned.”
This concern dissipated with the availability of more data. In a global registry that has so far captured more than 1,000 cutaneous reactions from 52 participating countries, it appears that about 2% of patients have a cutaneous reaction other than an ISR after the first dose. All resolve with minimal skin care or no treatment.
After the second dose, the proportion is lower. If there is a reaction, it typically occurs earlier and resolves more quickly.
“What we have learned is that fewer than half of patients who had a reaction to the first dose have a reaction to the second, and those who did have a reaction had a milder course,” said Dr. Freeman.
These data are “incredibly reassuring” on many levels, she explained. In addition, it allows clinicians to confidently explain to patients that there are no serious sequelae from the rashes, whether immediate or delayed, from the available COVID-19 vaccines.
“Every skin reaction I have seen is something we can treat through,” she added, noting that most reactions resolve with little or no supportive care. Following skin reactions, particularly the delayed lesions, it is not uncommon for patients to refuse a second shot. Some request a medical waiver to avoid further vaccine exposure. According to Dr. Freeman, this is unwarranted.
“I have granted exactly zero waivers,” she said. She explains to patients that these reactions have not been predictive of serious events, such as anaphylaxis. Although the trigger of the hypersensitivity reaction remains unknown, there is no evidence of serious consequences.
Delayed skin reactions are more commonly associated with the Moderna than the Pfizer vaccine. One notable difference between these vaccines is the greater content of mRNA in the Moderna formulation, but Freeman said that this is only one potential hypothesis for higher frequency of reactions to this version of the vaccine.
Patients with a history of allergic disease are more likely to develop a reaction but not significantly more likely to have a reaction that is more difficult to manage, according to Kimberly G. Blumenthal, MD, quality and safety officer for allergy, and codirector of the clinical epidemiology program in the division of rheumatology, allergy, and immunology at Mass General.
Anaphylaxis has been associated with COVD-19 vaccines just as it has with essentially every injectable vaccine, Dr. Blumenthal said during the same session. But the risk is very low, and it stays low even among those with a history of severe hypersensitivity reactions in the past.
Among the data collected from more than 52,000 vaccinated MGBHS employees, 0.9% had a history of severe allergic reaction to a prior vaccine. Of these, 11.6% had an allergic reaction to the COVID-19 vaccine. This was more than twice the 4.6% rate of allergic reactions among employees without a history of allergic reactions, but serious consequences were rare in both groups.
Of those with a reaction to the first dose, all but 2.4% took a subsequent dose. Again, serious reactions were exceedingly rare. These serious reactions did include anaphylaxis and hospitalization in 3% of patients, but there were no fatalities and all resolved.
The absence of serious sequelae from a reaction to a COVID-19 vaccine must be considered within the context of the benefit, which includes protection from death and hospitalization from the virus, according to Dr. Blumenthal. Citing the evidence that first-shot reactions are a source of vaccine hesitancy, she agreed that it is important to educate patients about relative risks.
“Even in our own cohort of MGBHS employees, we have people, including those who had been provaccine in the past, become hesitant,” commented Dr. Blumenthal, who said there are data from the Kaiser Permanente System showing similar vaccine reluctance following a first-shot reaction.
After more than 500 million doses of the Moderna and Pfizer vaccines had been administered worldwide, there was not a single reported death from anaphylaxis. Although Dr. Blumenthal said that an unconfirmed death of this type had been recently reported, she emphasized that this single death, if valid, is dwarfed by the lives saved with vaccination.
Asked about her strategy for counseling patients with vaccine hesitancy, Dr. Freeman said the body of safety data is large and compelling. There is overwhelming evidence of a favorable benefit-to-risk ratio overall and among those with a first-shot reaction.
“I can reassure them on the basis of the data,” Dr. Freeman said in an interview. “Less than half will have a reaction to the second shot and even if they do have a reaction, it is likely to be less severe.”
Although the main message is that vaccination is potentially lifesaving and far outweighs any risks, Freeman specifically gives this message to those hesitant to take a second shot after a first-shot reaction: “I can get you through it.”
Dr. Freeman encouraged health care professionals to report cases of COVID-19 vaccine–related dermatologic side effects to the American Academy of Dermatology / International League of Dermatologic Societies COVID-19 dermatology registry. Dermatologic manifestations of COVID-19 can also be reported to the registry.
Dr. Freeman disclosed receiving grants/research funding from the International League of Dermatologic Societies and from the National Institutes of Health. Dr. Blumenthal disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
BOSTON – Requests for a according to an analysis of several large sets of data presented at the annual meeting of the American Academy of Dermatology.
According to the data, “there are no serious adverse consequences from these cutaneous reactions,” said Esther Freeman, MD, PhD, director of Global Health Dermatology, Massachusetts General Hospital, Boston.
This is important because the risk of vaccine hesitancy goes up dramatically in patients who experience reactions to the first vaccine dose, according to follow-up of more than 50,000 employees vaccinated in the Mass General Brigham Healthcare System (MGBHS). According to Dr. Freeman, there was almost a fourfold increase in the rate of second-dose refusals for those with cutaneous reactions and a more than fourfold increase in those who developed angioedema.
Before the data were available, skin reactions were a source of concern among dermatologists and others involved in monitoring vaccine-related adverse events. Injection site reactions (ISRs) are associated with essentially every injectable vaccine, so these were expected, but a small proportion of patients developed large red plaques in the injection arm 7-8 days after the inoculation.
“These delayed reactions caused a lot of initial panic,” said Dr. Freeman, who counted herself among those alarmed about what the reactions might signify. “Was this cellulitis? Would the next dose cause anaphylaxis? We were concerned.”
This concern dissipated with the availability of more data. In a global registry that has so far captured more than 1,000 cutaneous reactions from 52 participating countries, it appears that about 2% of patients have a cutaneous reaction other than an ISR after the first dose. All resolve with minimal skin care or no treatment.
After the second dose, the proportion is lower. If there is a reaction, it typically occurs earlier and resolves more quickly.
“What we have learned is that fewer than half of patients who had a reaction to the first dose have a reaction to the second, and those who did have a reaction had a milder course,” said Dr. Freeman.
These data are “incredibly reassuring” on many levels, she explained. In addition, it allows clinicians to confidently explain to patients that there are no serious sequelae from the rashes, whether immediate or delayed, from the available COVID-19 vaccines.
“Every skin reaction I have seen is something we can treat through,” she added, noting that most reactions resolve with little or no supportive care. Following skin reactions, particularly the delayed lesions, it is not uncommon for patients to refuse a second shot. Some request a medical waiver to avoid further vaccine exposure. According to Dr. Freeman, this is unwarranted.
“I have granted exactly zero waivers,” she said. She explains to patients that these reactions have not been predictive of serious events, such as anaphylaxis. Although the trigger of the hypersensitivity reaction remains unknown, there is no evidence of serious consequences.
Delayed skin reactions are more commonly associated with the Moderna than the Pfizer vaccine. One notable difference between these vaccines is the greater content of mRNA in the Moderna formulation, but Freeman said that this is only one potential hypothesis for higher frequency of reactions to this version of the vaccine.
Patients with a history of allergic disease are more likely to develop a reaction but not significantly more likely to have a reaction that is more difficult to manage, according to Kimberly G. Blumenthal, MD, quality and safety officer for allergy, and codirector of the clinical epidemiology program in the division of rheumatology, allergy, and immunology at Mass General.
Anaphylaxis has been associated with COVD-19 vaccines just as it has with essentially every injectable vaccine, Dr. Blumenthal said during the same session. But the risk is very low, and it stays low even among those with a history of severe hypersensitivity reactions in the past.
Among the data collected from more than 52,000 vaccinated MGBHS employees, 0.9% had a history of severe allergic reaction to a prior vaccine. Of these, 11.6% had an allergic reaction to the COVID-19 vaccine. This was more than twice the 4.6% rate of allergic reactions among employees without a history of allergic reactions, but serious consequences were rare in both groups.
Of those with a reaction to the first dose, all but 2.4% took a subsequent dose. Again, serious reactions were exceedingly rare. These serious reactions did include anaphylaxis and hospitalization in 3% of patients, but there were no fatalities and all resolved.
The absence of serious sequelae from a reaction to a COVID-19 vaccine must be considered within the context of the benefit, which includes protection from death and hospitalization from the virus, according to Dr. Blumenthal. Citing the evidence that first-shot reactions are a source of vaccine hesitancy, she agreed that it is important to educate patients about relative risks.
“Even in our own cohort of MGBHS employees, we have people, including those who had been provaccine in the past, become hesitant,” commented Dr. Blumenthal, who said there are data from the Kaiser Permanente System showing similar vaccine reluctance following a first-shot reaction.
After more than 500 million doses of the Moderna and Pfizer vaccines had been administered worldwide, there was not a single reported death from anaphylaxis. Although Dr. Blumenthal said that an unconfirmed death of this type had been recently reported, she emphasized that this single death, if valid, is dwarfed by the lives saved with vaccination.
Asked about her strategy for counseling patients with vaccine hesitancy, Dr. Freeman said the body of safety data is large and compelling. There is overwhelming evidence of a favorable benefit-to-risk ratio overall and among those with a first-shot reaction.
“I can reassure them on the basis of the data,” Dr. Freeman said in an interview. “Less than half will have a reaction to the second shot and even if they do have a reaction, it is likely to be less severe.”
Although the main message is that vaccination is potentially lifesaving and far outweighs any risks, Freeman specifically gives this message to those hesitant to take a second shot after a first-shot reaction: “I can get you through it.”
Dr. Freeman encouraged health care professionals to report cases of COVID-19 vaccine–related dermatologic side effects to the American Academy of Dermatology / International League of Dermatologic Societies COVID-19 dermatology registry. Dermatologic manifestations of COVID-19 can also be reported to the registry.
Dr. Freeman disclosed receiving grants/research funding from the International League of Dermatologic Societies and from the National Institutes of Health. Dr. Blumenthal disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
AT AAD 2022
Fingers take the fight to COVID-19
Pointing a finger at COVID-19
The battle against COVID-19 is seemingly never ending. It’s been 2 years and still we struggle against the virus. But now, a new hero rises against the eternal menace, a powerful weapon against this scourge of humanity. And that weapon? Finger length.
Before you break out the sad trombone, hear us out. One of the big questions around COVID-19 is the role testosterone plays in its severity: Does low testosterone increase or decrease the odds of contracting severe COVID-19? To help answer that question, English researchers have published a study analyzing finger length ratios in both COVID-19 patients and a healthy control group. That seems random, but high testosterone in the womb leads to longer ring fingers in adulthood, while high estrogen leads to longer index fingers.
According to the researchers, those who had significant left hand–right hand differences in the ratio between the second and fourth digits, as well as the third and fifth digits, were significantly more likely to have severe COVID-19 compared with those with more even ratios. Those with “feminized” short little fingers were also at risk. Those large ratio differences indicate low testosterone and high estrogen, which may explain why elderly men are at such high risk for severe COVID-19. Testosterone naturally falls off as men get older.
The results add credence to clinical trials looking to use testosterone-boosting drugs against COVID-19, the researchers said. It also gives credence to LOTME’s brand-new 12-step finger strength fitness routine and our branded finger weights. Now just $19.95! It’s the bargain of the century! Boost your testosterone naturally and protect yourself from COVID-19! We promise it’s not a scam.
Some emergencies need a superhero
Last week, we learned about the most boring person in the world. This week just happens to be opposite week, so we’re looking at a candidate for the most interesting person. Someone who can swoop down from the sky to save the injured and helpless. Someone who can go where helicopters fear to tread. Someone with jet engines for arms. Superhero-type stuff.
The Great North Air Ambulance Service (GNAAS), a charitable organization located in the United Kingdom, recently announced that one of its members has completed training on the Gravity Industries Jet Suit. The suit “has two engines on each arm and a larger engine on the back [that] provide up to 317 pounds of thrust,” Interesting Engineering explained.
GNAAS is putting the suit into operation in England’s Lake District National Park, which includes mountainous terrain that is not very hospitable to helicopter landings. A paramedic using the suit can reach hikers stranded on mountainsides much faster than rescuers who have to run or hike from the nearest helicopter landing site.
“Everyone looks at the wow factor and the fact we are the world’s first jet suit paramedics, but for us, it’s about delivering patient care,” GNAAS’ Andy Mawson told Interesting Engineering. Sounds like superhero-speak to us.
So if you’re in the Lake District and have taken a bit of a tumble, you can call a superhero on your cell phone or you can use this to summon one.
Why we’re rejecting food as medicine
Humans have been using food to treat ailments much longer than we’ve had the advances of modern medicine. So why have we rejected its worth in our treatment processes? And what can be done to change that? The Center for Food as Medicine and the Hunter College NYC Food Policy Center just released a 335-page report that answers those questions.
First, the why: Meals in health care settings are not medically designed to help with the specific needs of the patient. Produce-prescription and nutrition-incentive programs don’t have the government funds to fully support them. And a lot of medical schools don’t even require students to take a basic nutrition course. So there’s a lack of knowledge and a disconnect between health care providers and food as a resource.
Then there’s a lack of trust in the food industry and their validity. Social media uses food as a means of promoting “pseudoscientific alternative medicine” or spreading false info, pushing away legitimate providers. The food industry has had its fingers in food science studies and an almost mafia-esque chokehold on American dietary guidelines. No wonder food for medicine is getting the boot!
To change the situation, the report offers 10 key recommendations on how to advance the idea of incorporating food into medicine for treatment and prevention. They include boosting the funding for research, making hospitals more food-as-medicine focused, expanding federal programs, and improving public awareness on the role nutrition can play in medical treatment or prevention.
So maybe instead of rejecting food outright, we should be looking a little deeper at how we can use it to our advantage. Just a thought: Ice cream as an antidepressant.
Being rude is a good thing, apparently
If you’ve ever been called argumentative, stubborn, or unpleasant, then this LOTME is for you. Researchers at the University of Geneva have found that people who are more stubborn and hate to conform have brains that are more protected against Alzheimer’s disease. That type of personality seems to preserve the part of the brain that usually deteriorates as we grow older.
The original hypothesis that personality may have a protective effect against brain degeneration led the investigators to conduct cognitive and personality assessments of 65 elderly participants over a 5-year period. Researchers have been attempting to create vaccines to protect against Alzheimer’s disease, but these new findings offer a nonbiological way to help.
“For a long time, the brain is able to compensate by activating alternative networks; when the first clinical signs appear, however, it is unfortunately often too late. The identification of early biomarkers is therefore essential for … effective disease management,” lead author Panteleimon Giannakopoulos, MD, said in a Study Finds report.
You may be wondering how people with more agreeable and less confrontational personalities can seek help. Well, researchers are working on that, too. It’s a complex situation, but as always, we’re rooting for you, science!
At least now you can take solace in the fact that your elderly next-door neighbor who yells at you for stepping on his lawn is probably more protected against Alzheimer’s disease.
Pointing a finger at COVID-19
The battle against COVID-19 is seemingly never ending. It’s been 2 years and still we struggle against the virus. But now, a new hero rises against the eternal menace, a powerful weapon against this scourge of humanity. And that weapon? Finger length.
Before you break out the sad trombone, hear us out. One of the big questions around COVID-19 is the role testosterone plays in its severity: Does low testosterone increase or decrease the odds of contracting severe COVID-19? To help answer that question, English researchers have published a study analyzing finger length ratios in both COVID-19 patients and a healthy control group. That seems random, but high testosterone in the womb leads to longer ring fingers in adulthood, while high estrogen leads to longer index fingers.
According to the researchers, those who had significant left hand–right hand differences in the ratio between the second and fourth digits, as well as the third and fifth digits, were significantly more likely to have severe COVID-19 compared with those with more even ratios. Those with “feminized” short little fingers were also at risk. Those large ratio differences indicate low testosterone and high estrogen, which may explain why elderly men are at such high risk for severe COVID-19. Testosterone naturally falls off as men get older.
The results add credence to clinical trials looking to use testosterone-boosting drugs against COVID-19, the researchers said. It also gives credence to LOTME’s brand-new 12-step finger strength fitness routine and our branded finger weights. Now just $19.95! It’s the bargain of the century! Boost your testosterone naturally and protect yourself from COVID-19! We promise it’s not a scam.
Some emergencies need a superhero
Last week, we learned about the most boring person in the world. This week just happens to be opposite week, so we’re looking at a candidate for the most interesting person. Someone who can swoop down from the sky to save the injured and helpless. Someone who can go where helicopters fear to tread. Someone with jet engines for arms. Superhero-type stuff.
The Great North Air Ambulance Service (GNAAS), a charitable organization located in the United Kingdom, recently announced that one of its members has completed training on the Gravity Industries Jet Suit. The suit “has two engines on each arm and a larger engine on the back [that] provide up to 317 pounds of thrust,” Interesting Engineering explained.
GNAAS is putting the suit into operation in England’s Lake District National Park, which includes mountainous terrain that is not very hospitable to helicopter landings. A paramedic using the suit can reach hikers stranded on mountainsides much faster than rescuers who have to run or hike from the nearest helicopter landing site.
“Everyone looks at the wow factor and the fact we are the world’s first jet suit paramedics, but for us, it’s about delivering patient care,” GNAAS’ Andy Mawson told Interesting Engineering. Sounds like superhero-speak to us.
So if you’re in the Lake District and have taken a bit of a tumble, you can call a superhero on your cell phone or you can use this to summon one.
Why we’re rejecting food as medicine
Humans have been using food to treat ailments much longer than we’ve had the advances of modern medicine. So why have we rejected its worth in our treatment processes? And what can be done to change that? The Center for Food as Medicine and the Hunter College NYC Food Policy Center just released a 335-page report that answers those questions.
First, the why: Meals in health care settings are not medically designed to help with the specific needs of the patient. Produce-prescription and nutrition-incentive programs don’t have the government funds to fully support them. And a lot of medical schools don’t even require students to take a basic nutrition course. So there’s a lack of knowledge and a disconnect between health care providers and food as a resource.
Then there’s a lack of trust in the food industry and their validity. Social media uses food as a means of promoting “pseudoscientific alternative medicine” or spreading false info, pushing away legitimate providers. The food industry has had its fingers in food science studies and an almost mafia-esque chokehold on American dietary guidelines. No wonder food for medicine is getting the boot!
To change the situation, the report offers 10 key recommendations on how to advance the idea of incorporating food into medicine for treatment and prevention. They include boosting the funding for research, making hospitals more food-as-medicine focused, expanding federal programs, and improving public awareness on the role nutrition can play in medical treatment or prevention.
So maybe instead of rejecting food outright, we should be looking a little deeper at how we can use it to our advantage. Just a thought: Ice cream as an antidepressant.
Being rude is a good thing, apparently
If you’ve ever been called argumentative, stubborn, or unpleasant, then this LOTME is for you. Researchers at the University of Geneva have found that people who are more stubborn and hate to conform have brains that are more protected against Alzheimer’s disease. That type of personality seems to preserve the part of the brain that usually deteriorates as we grow older.
The original hypothesis that personality may have a protective effect against brain degeneration led the investigators to conduct cognitive and personality assessments of 65 elderly participants over a 5-year period. Researchers have been attempting to create vaccines to protect against Alzheimer’s disease, but these new findings offer a nonbiological way to help.
“For a long time, the brain is able to compensate by activating alternative networks; when the first clinical signs appear, however, it is unfortunately often too late. The identification of early biomarkers is therefore essential for … effective disease management,” lead author Panteleimon Giannakopoulos, MD, said in a Study Finds report.
You may be wondering how people with more agreeable and less confrontational personalities can seek help. Well, researchers are working on that, too. It’s a complex situation, but as always, we’re rooting for you, science!
At least now you can take solace in the fact that your elderly next-door neighbor who yells at you for stepping on his lawn is probably more protected against Alzheimer’s disease.
Pointing a finger at COVID-19
The battle against COVID-19 is seemingly never ending. It’s been 2 years and still we struggle against the virus. But now, a new hero rises against the eternal menace, a powerful weapon against this scourge of humanity. And that weapon? Finger length.
Before you break out the sad trombone, hear us out. One of the big questions around COVID-19 is the role testosterone plays in its severity: Does low testosterone increase or decrease the odds of contracting severe COVID-19? To help answer that question, English researchers have published a study analyzing finger length ratios in both COVID-19 patients and a healthy control group. That seems random, but high testosterone in the womb leads to longer ring fingers in adulthood, while high estrogen leads to longer index fingers.
According to the researchers, those who had significant left hand–right hand differences in the ratio between the second and fourth digits, as well as the third and fifth digits, were significantly more likely to have severe COVID-19 compared with those with more even ratios. Those with “feminized” short little fingers were also at risk. Those large ratio differences indicate low testosterone and high estrogen, which may explain why elderly men are at such high risk for severe COVID-19. Testosterone naturally falls off as men get older.
The results add credence to clinical trials looking to use testosterone-boosting drugs against COVID-19, the researchers said. It also gives credence to LOTME’s brand-new 12-step finger strength fitness routine and our branded finger weights. Now just $19.95! It’s the bargain of the century! Boost your testosterone naturally and protect yourself from COVID-19! We promise it’s not a scam.
Some emergencies need a superhero
Last week, we learned about the most boring person in the world. This week just happens to be opposite week, so we’re looking at a candidate for the most interesting person. Someone who can swoop down from the sky to save the injured and helpless. Someone who can go where helicopters fear to tread. Someone with jet engines for arms. Superhero-type stuff.
The Great North Air Ambulance Service (GNAAS), a charitable organization located in the United Kingdom, recently announced that one of its members has completed training on the Gravity Industries Jet Suit. The suit “has two engines on each arm and a larger engine on the back [that] provide up to 317 pounds of thrust,” Interesting Engineering explained.
GNAAS is putting the suit into operation in England’s Lake District National Park, which includes mountainous terrain that is not very hospitable to helicopter landings. A paramedic using the suit can reach hikers stranded on mountainsides much faster than rescuers who have to run or hike from the nearest helicopter landing site.
“Everyone looks at the wow factor and the fact we are the world’s first jet suit paramedics, but for us, it’s about delivering patient care,” GNAAS’ Andy Mawson told Interesting Engineering. Sounds like superhero-speak to us.
So if you’re in the Lake District and have taken a bit of a tumble, you can call a superhero on your cell phone or you can use this to summon one.
Why we’re rejecting food as medicine
Humans have been using food to treat ailments much longer than we’ve had the advances of modern medicine. So why have we rejected its worth in our treatment processes? And what can be done to change that? The Center for Food as Medicine and the Hunter College NYC Food Policy Center just released a 335-page report that answers those questions.
First, the why: Meals in health care settings are not medically designed to help with the specific needs of the patient. Produce-prescription and nutrition-incentive programs don’t have the government funds to fully support them. And a lot of medical schools don’t even require students to take a basic nutrition course. So there’s a lack of knowledge and a disconnect between health care providers and food as a resource.
Then there’s a lack of trust in the food industry and their validity. Social media uses food as a means of promoting “pseudoscientific alternative medicine” or spreading false info, pushing away legitimate providers. The food industry has had its fingers in food science studies and an almost mafia-esque chokehold on American dietary guidelines. No wonder food for medicine is getting the boot!
To change the situation, the report offers 10 key recommendations on how to advance the idea of incorporating food into medicine for treatment and prevention. They include boosting the funding for research, making hospitals more food-as-medicine focused, expanding federal programs, and improving public awareness on the role nutrition can play in medical treatment or prevention.
So maybe instead of rejecting food outright, we should be looking a little deeper at how we can use it to our advantage. Just a thought: Ice cream as an antidepressant.
Being rude is a good thing, apparently
If you’ve ever been called argumentative, stubborn, or unpleasant, then this LOTME is for you. Researchers at the University of Geneva have found that people who are more stubborn and hate to conform have brains that are more protected against Alzheimer’s disease. That type of personality seems to preserve the part of the brain that usually deteriorates as we grow older.
The original hypothesis that personality may have a protective effect against brain degeneration led the investigators to conduct cognitive and personality assessments of 65 elderly participants over a 5-year period. Researchers have been attempting to create vaccines to protect against Alzheimer’s disease, but these new findings offer a nonbiological way to help.
“For a long time, the brain is able to compensate by activating alternative networks; when the first clinical signs appear, however, it is unfortunately often too late. The identification of early biomarkers is therefore essential for … effective disease management,” lead author Panteleimon Giannakopoulos, MD, said in a Study Finds report.
You may be wondering how people with more agreeable and less confrontational personalities can seek help. Well, researchers are working on that, too. It’s a complex situation, but as always, we’re rooting for you, science!
At least now you can take solace in the fact that your elderly next-door neighbor who yells at you for stepping on his lawn is probably more protected against Alzheimer’s disease.
Does evidence support benefits of omega-3 fatty acids?
Dietary supplements that contain omega-3 fatty acids have been widely consumed for years. Researchers have been investigating the benefits of such preparations for cardiovascular, neurologic, and psychological conditions. A recently published study on omega-3 fatty acids and depression inspired neurologist Hans-Christoph Diener, MD, PhD, of the Institute for Epidemiology at the University Duisburg-Essen (Germany), to examine scientific publications concerning omega-3 fatty acids or fish-oil capsules in more detail.
Prevention of depression
Dr. Diener told the story of how he stumbled upon an interesting article in JAMA in December 2021. It was about a placebo-controlled study that investigated whether omega-3 fatty acids can prevent incident depression.
As the study authors reported, treatment with omega-3 preparations in adults aged 50 years or older without clinically relevant symptoms of depression at study initiation was associated with a small but statistically significant increase in the risk for depression or clinically relevant symptoms of depression. There was no difference in mood scale value, however, over a median follow-up of 5.3 years. According to the study authors, these results did not support the administration of omega-3 preparations for the prevention of depression.
This study was, as Dr. Diener said, somewhat negative, but it did arouse his interest in questions such as what biological effects omega-3 fatty acids have and what is known “about this topic with regard to neurology,” he said. When reviewing the literature, he noticed that there “were association studies, i.e., studies that describe that the intake of omega-3 fatty acids may possibly be associated with a lower risk of certain diseases.”
Beginning with the Inuit
It all started “with observations of the Inuit [population] in Greenland and Alaska after World War II, because it was remarked upon that these people ate a lot of fish and seal meat and had a very low incidence of cardiovascular diseases.” Over the years, a large number of association studies have been published, which may have encouraged the assumption that omega-3 fatty acids have positive health effects on various conditions, such as cardiovascular diseases, hyperlipidemia, type 2 diabetes, various malignancies, cognitive impairments, Alzheimer’s disease, depression and anxiety disorders, heart failure, slipped disks, ADHD, symptoms of menopause, rheumatoid arthritis, asthma, periodontitis, epilepsy, chemotherapy tolerance, premenstrual syndrome, and nonalcoholic fatty liver disease.
Dr. Diener believes that the problem is that these are association studies. But association does not mean that there is a causal relationship.
Disappointing study results
On the contrary, the results from the randomized placebo-controlled studies are truly frustrating, according to the neurologist. A meta-analysis of the use of omega-3 fatty acids in cardiovascular diseases included 86 studies with over 162,000 patients. According to Dr. Diener, it did not reveal any benefit for overall and cardiovascular mortality, nor any benefit for the reduction of myocardial infarction and stroke.
The results did indicate a trend, however, for reduced mortality in coronary heart disease. Even so, the number needed to treat for this was 334, which means that 334 people would have to take omega-3 fatty acids for years to prevent one fatal cardiac event.
Aside from this study, Dr. Diener found six studies on Alzheimer’s disease and three studies on dementia with patient populations between 600 and 800. In these studies, too, a positive effect of omega-3 fatty acids could not be identified. Then he discovered another 31 placebo-controlled studies of omega-3 fatty acids for the treatment or prevention of depression and anxiety disorder. Despite including 50,000 patients, these studies also did not show any positive effect.
“I see a significant discrepancy between the promotion of omega-3 fatty acids, whether it’s on television, in the ‘yellow’ [journalism] press, or in advertisements, and the actual scientific evidence,” said Dr. Diener. “At least from a neurological perspective, there is no evidence that omega-3 fatty acids have any benefit. This is true for strokes, dementia, Alzheimer’s disease, depression, and anxiety disorders.”
Potential adverse effects
Omega-3 fatty acids also have potentially adverse effects. The VITAL Rhythm study recently provided evidence that, depending on the dose, preparations with omega-3 fatty acids may increase the risk for atrial fibrillation. As the authors wrote, the results do not support taking omega-3 fatty acids to prevent atrial fibrillation.
In 2019, the global market for omega-3 fatty acids reached a value of $4.1 billion. This value is expected to double by 2025, according to a comment by Gregory Curfman, MD, deputy editor of JAMA and lecturer in health care policy at Harvard Medical School, Boston.
As Dr. Curfman wrote, this impressive amount of expenditure shows how beloved these products are and how strongly many people believe that omega-3 fatty acids are beneficial for their health. It is therefore important to know the potential risks of such preparations. One such example for this would be the risk for atrial fibrillation.
According to Dr. Curfman, in the last 2 years, four randomized clinical studies have provided data on the risk for atrial fibrillation associated with omega-3 fatty acids. In the STRENGTH study, 13,078 high-risk patients with cardiovascular diseases were randomly assigned to one of two groups. The subjects received either a high dose (4 g/day) of a combination of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) or corn oil. After a median of 42 months, there was no significant difference between the two groups in the primary composite cardiovascular endpoint, but more frequent atrial fibrillation in the omega-3 fatty acid group, compared with the corn oil group (2.2% vs. 1.3%; hazard ratio, 1.69; 95% confidence interval, 1.29-2.21; P < .001).
In the REDUCE-IT study, 8179 subjects were randomly assigned to a high dose (4 g/day, as in STRENGTH) of an omega-3 fatty acid preparation consisting of a purified EPA (icosapent ethyl) or mineral oil. After a median observation period of 4.9 years, icosapent ethyl was associated with a relative reduction of the primary composite cardiovascular endpoint by 25%, compared with mineral oil. As in the STRENGTH study, this study found that the risk for atrial fibrillation associated with omega-3 fatty acids, compared with mineral oil, was significantly higher (5.3% vs. 3.9%; P = .003).
In a third study (OMEMI), as Dr. Curfman reported, 1027 elderly patients who had recently had a myocardial infarction were randomly assigned to receive either a median dose of 1.8 g/day of omega-3 fatty acids (a combination of EPA and DHA) or corn oil. After 2 years, there was no significant difference between the two groups in primary composite cardiovascular endpoints, but 7.2% of the patients taking omega-3 fatty acids developed atrial fibrillation. In the corn oil group, this proportion was 4% (HR, 1.84; 95% CI, 0.98-3.45; P = .06).
The data from the four studies together indicate a potential dose-dependent risk for atrial fibrillation associated with omega-3 fatty acids, according to Dr. Curfman. At a dose of 4.0 g/day, there is a highly significant risk increase (almost double). With a median dose of 1.8 g/day, the risk increase (HR, 1.84) did not reach statistical significance. At a daily standard dose of 840 mg/day, an increase in risk could not be determined.
Dr. Curfman’s recommendation is that patients who take, or want to take, preparations with omega-3 fatty acids be informed of the potential development of arrhythmia at higher dosages. These patients also should undergo cardiological monitoring.
A version of this article first appeared on Medscape.com.
Dietary supplements that contain omega-3 fatty acids have been widely consumed for years. Researchers have been investigating the benefits of such preparations for cardiovascular, neurologic, and psychological conditions. A recently published study on omega-3 fatty acids and depression inspired neurologist Hans-Christoph Diener, MD, PhD, of the Institute for Epidemiology at the University Duisburg-Essen (Germany), to examine scientific publications concerning omega-3 fatty acids or fish-oil capsules in more detail.
Prevention of depression
Dr. Diener told the story of how he stumbled upon an interesting article in JAMA in December 2021. It was about a placebo-controlled study that investigated whether omega-3 fatty acids can prevent incident depression.
As the study authors reported, treatment with omega-3 preparations in adults aged 50 years or older without clinically relevant symptoms of depression at study initiation was associated with a small but statistically significant increase in the risk for depression or clinically relevant symptoms of depression. There was no difference in mood scale value, however, over a median follow-up of 5.3 years. According to the study authors, these results did not support the administration of omega-3 preparations for the prevention of depression.
This study was, as Dr. Diener said, somewhat negative, but it did arouse his interest in questions such as what biological effects omega-3 fatty acids have and what is known “about this topic with regard to neurology,” he said. When reviewing the literature, he noticed that there “were association studies, i.e., studies that describe that the intake of omega-3 fatty acids may possibly be associated with a lower risk of certain diseases.”
Beginning with the Inuit
It all started “with observations of the Inuit [population] in Greenland and Alaska after World War II, because it was remarked upon that these people ate a lot of fish and seal meat and had a very low incidence of cardiovascular diseases.” Over the years, a large number of association studies have been published, which may have encouraged the assumption that omega-3 fatty acids have positive health effects on various conditions, such as cardiovascular diseases, hyperlipidemia, type 2 diabetes, various malignancies, cognitive impairments, Alzheimer’s disease, depression and anxiety disorders, heart failure, slipped disks, ADHD, symptoms of menopause, rheumatoid arthritis, asthma, periodontitis, epilepsy, chemotherapy tolerance, premenstrual syndrome, and nonalcoholic fatty liver disease.
Dr. Diener believes that the problem is that these are association studies. But association does not mean that there is a causal relationship.
Disappointing study results
On the contrary, the results from the randomized placebo-controlled studies are truly frustrating, according to the neurologist. A meta-analysis of the use of omega-3 fatty acids in cardiovascular diseases included 86 studies with over 162,000 patients. According to Dr. Diener, it did not reveal any benefit for overall and cardiovascular mortality, nor any benefit for the reduction of myocardial infarction and stroke.
The results did indicate a trend, however, for reduced mortality in coronary heart disease. Even so, the number needed to treat for this was 334, which means that 334 people would have to take omega-3 fatty acids for years to prevent one fatal cardiac event.
Aside from this study, Dr. Diener found six studies on Alzheimer’s disease and three studies on dementia with patient populations between 600 and 800. In these studies, too, a positive effect of omega-3 fatty acids could not be identified. Then he discovered another 31 placebo-controlled studies of omega-3 fatty acids for the treatment or prevention of depression and anxiety disorder. Despite including 50,000 patients, these studies also did not show any positive effect.
“I see a significant discrepancy between the promotion of omega-3 fatty acids, whether it’s on television, in the ‘yellow’ [journalism] press, or in advertisements, and the actual scientific evidence,” said Dr. Diener. “At least from a neurological perspective, there is no evidence that omega-3 fatty acids have any benefit. This is true for strokes, dementia, Alzheimer’s disease, depression, and anxiety disorders.”
Potential adverse effects
Omega-3 fatty acids also have potentially adverse effects. The VITAL Rhythm study recently provided evidence that, depending on the dose, preparations with omega-3 fatty acids may increase the risk for atrial fibrillation. As the authors wrote, the results do not support taking omega-3 fatty acids to prevent atrial fibrillation.
In 2019, the global market for omega-3 fatty acids reached a value of $4.1 billion. This value is expected to double by 2025, according to a comment by Gregory Curfman, MD, deputy editor of JAMA and lecturer in health care policy at Harvard Medical School, Boston.
As Dr. Curfman wrote, this impressive amount of expenditure shows how beloved these products are and how strongly many people believe that omega-3 fatty acids are beneficial for their health. It is therefore important to know the potential risks of such preparations. One such example for this would be the risk for atrial fibrillation.
According to Dr. Curfman, in the last 2 years, four randomized clinical studies have provided data on the risk for atrial fibrillation associated with omega-3 fatty acids. In the STRENGTH study, 13,078 high-risk patients with cardiovascular diseases were randomly assigned to one of two groups. The subjects received either a high dose (4 g/day) of a combination of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) or corn oil. After a median of 42 months, there was no significant difference between the two groups in the primary composite cardiovascular endpoint, but more frequent atrial fibrillation in the omega-3 fatty acid group, compared with the corn oil group (2.2% vs. 1.3%; hazard ratio, 1.69; 95% confidence interval, 1.29-2.21; P < .001).
In the REDUCE-IT study, 8179 subjects were randomly assigned to a high dose (4 g/day, as in STRENGTH) of an omega-3 fatty acid preparation consisting of a purified EPA (icosapent ethyl) or mineral oil. After a median observation period of 4.9 years, icosapent ethyl was associated with a relative reduction of the primary composite cardiovascular endpoint by 25%, compared with mineral oil. As in the STRENGTH study, this study found that the risk for atrial fibrillation associated with omega-3 fatty acids, compared with mineral oil, was significantly higher (5.3% vs. 3.9%; P = .003).
In a third study (OMEMI), as Dr. Curfman reported, 1027 elderly patients who had recently had a myocardial infarction were randomly assigned to receive either a median dose of 1.8 g/day of omega-3 fatty acids (a combination of EPA and DHA) or corn oil. After 2 years, there was no significant difference between the two groups in primary composite cardiovascular endpoints, but 7.2% of the patients taking omega-3 fatty acids developed atrial fibrillation. In the corn oil group, this proportion was 4% (HR, 1.84; 95% CI, 0.98-3.45; P = .06).
The data from the four studies together indicate a potential dose-dependent risk for atrial fibrillation associated with omega-3 fatty acids, according to Dr. Curfman. At a dose of 4.0 g/day, there is a highly significant risk increase (almost double). With a median dose of 1.8 g/day, the risk increase (HR, 1.84) did not reach statistical significance. At a daily standard dose of 840 mg/day, an increase in risk could not be determined.
Dr. Curfman’s recommendation is that patients who take, or want to take, preparations with omega-3 fatty acids be informed of the potential development of arrhythmia at higher dosages. These patients also should undergo cardiological monitoring.
A version of this article first appeared on Medscape.com.
Dietary supplements that contain omega-3 fatty acids have been widely consumed for years. Researchers have been investigating the benefits of such preparations for cardiovascular, neurologic, and psychological conditions. A recently published study on omega-3 fatty acids and depression inspired neurologist Hans-Christoph Diener, MD, PhD, of the Institute for Epidemiology at the University Duisburg-Essen (Germany), to examine scientific publications concerning omega-3 fatty acids or fish-oil capsules in more detail.
Prevention of depression
Dr. Diener told the story of how he stumbled upon an interesting article in JAMA in December 2021. It was about a placebo-controlled study that investigated whether omega-3 fatty acids can prevent incident depression.
As the study authors reported, treatment with omega-3 preparations in adults aged 50 years or older without clinically relevant symptoms of depression at study initiation was associated with a small but statistically significant increase in the risk for depression or clinically relevant symptoms of depression. There was no difference in mood scale value, however, over a median follow-up of 5.3 years. According to the study authors, these results did not support the administration of omega-3 preparations for the prevention of depression.
This study was, as Dr. Diener said, somewhat negative, but it did arouse his interest in questions such as what biological effects omega-3 fatty acids have and what is known “about this topic with regard to neurology,” he said. When reviewing the literature, he noticed that there “were association studies, i.e., studies that describe that the intake of omega-3 fatty acids may possibly be associated with a lower risk of certain diseases.”
Beginning with the Inuit
It all started “with observations of the Inuit [population] in Greenland and Alaska after World War II, because it was remarked upon that these people ate a lot of fish and seal meat and had a very low incidence of cardiovascular diseases.” Over the years, a large number of association studies have been published, which may have encouraged the assumption that omega-3 fatty acids have positive health effects on various conditions, such as cardiovascular diseases, hyperlipidemia, type 2 diabetes, various malignancies, cognitive impairments, Alzheimer’s disease, depression and anxiety disorders, heart failure, slipped disks, ADHD, symptoms of menopause, rheumatoid arthritis, asthma, periodontitis, epilepsy, chemotherapy tolerance, premenstrual syndrome, and nonalcoholic fatty liver disease.
Dr. Diener believes that the problem is that these are association studies. But association does not mean that there is a causal relationship.
Disappointing study results
On the contrary, the results from the randomized placebo-controlled studies are truly frustrating, according to the neurologist. A meta-analysis of the use of omega-3 fatty acids in cardiovascular diseases included 86 studies with over 162,000 patients. According to Dr. Diener, it did not reveal any benefit for overall and cardiovascular mortality, nor any benefit for the reduction of myocardial infarction and stroke.
The results did indicate a trend, however, for reduced mortality in coronary heart disease. Even so, the number needed to treat for this was 334, which means that 334 people would have to take omega-3 fatty acids for years to prevent one fatal cardiac event.
Aside from this study, Dr. Diener found six studies on Alzheimer’s disease and three studies on dementia with patient populations between 600 and 800. In these studies, too, a positive effect of omega-3 fatty acids could not be identified. Then he discovered another 31 placebo-controlled studies of omega-3 fatty acids for the treatment or prevention of depression and anxiety disorder. Despite including 50,000 patients, these studies also did not show any positive effect.
“I see a significant discrepancy between the promotion of omega-3 fatty acids, whether it’s on television, in the ‘yellow’ [journalism] press, or in advertisements, and the actual scientific evidence,” said Dr. Diener. “At least from a neurological perspective, there is no evidence that omega-3 fatty acids have any benefit. This is true for strokes, dementia, Alzheimer’s disease, depression, and anxiety disorders.”
Potential adverse effects
Omega-3 fatty acids also have potentially adverse effects. The VITAL Rhythm study recently provided evidence that, depending on the dose, preparations with omega-3 fatty acids may increase the risk for atrial fibrillation. As the authors wrote, the results do not support taking omega-3 fatty acids to prevent atrial fibrillation.
In 2019, the global market for omega-3 fatty acids reached a value of $4.1 billion. This value is expected to double by 2025, according to a comment by Gregory Curfman, MD, deputy editor of JAMA and lecturer in health care policy at Harvard Medical School, Boston.
As Dr. Curfman wrote, this impressive amount of expenditure shows how beloved these products are and how strongly many people believe that omega-3 fatty acids are beneficial for their health. It is therefore important to know the potential risks of such preparations. One such example for this would be the risk for atrial fibrillation.
According to Dr. Curfman, in the last 2 years, four randomized clinical studies have provided data on the risk for atrial fibrillation associated with omega-3 fatty acids. In the STRENGTH study, 13,078 high-risk patients with cardiovascular diseases were randomly assigned to one of two groups. The subjects received either a high dose (4 g/day) of a combination of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) or corn oil. After a median of 42 months, there was no significant difference between the two groups in the primary composite cardiovascular endpoint, but more frequent atrial fibrillation in the omega-3 fatty acid group, compared with the corn oil group (2.2% vs. 1.3%; hazard ratio, 1.69; 95% confidence interval, 1.29-2.21; P < .001).
In the REDUCE-IT study, 8179 subjects were randomly assigned to a high dose (4 g/day, as in STRENGTH) of an omega-3 fatty acid preparation consisting of a purified EPA (icosapent ethyl) or mineral oil. After a median observation period of 4.9 years, icosapent ethyl was associated with a relative reduction of the primary composite cardiovascular endpoint by 25%, compared with mineral oil. As in the STRENGTH study, this study found that the risk for atrial fibrillation associated with omega-3 fatty acids, compared with mineral oil, was significantly higher (5.3% vs. 3.9%; P = .003).
In a third study (OMEMI), as Dr. Curfman reported, 1027 elderly patients who had recently had a myocardial infarction were randomly assigned to receive either a median dose of 1.8 g/day of omega-3 fatty acids (a combination of EPA and DHA) or corn oil. After 2 years, there was no significant difference between the two groups in primary composite cardiovascular endpoints, but 7.2% of the patients taking omega-3 fatty acids developed atrial fibrillation. In the corn oil group, this proportion was 4% (HR, 1.84; 95% CI, 0.98-3.45; P = .06).
The data from the four studies together indicate a potential dose-dependent risk for atrial fibrillation associated with omega-3 fatty acids, according to Dr. Curfman. At a dose of 4.0 g/day, there is a highly significant risk increase (almost double). With a median dose of 1.8 g/day, the risk increase (HR, 1.84) did not reach statistical significance. At a daily standard dose of 840 mg/day, an increase in risk could not be determined.
Dr. Curfman’s recommendation is that patients who take, or want to take, preparations with omega-3 fatty acids be informed of the potential development of arrhythmia at higher dosages. These patients also should undergo cardiological monitoring.
A version of this article first appeared on Medscape.com.
You’re not on a ‘best doctor’ list – does it matter?
Thousands of doctors get a shout out every year when they make the “Top Doctor” lists in various magazines. Some may be your colleagues or competitors. Should you be concerned if you’re not on the list?
Best Doctor lists are clearly popular with readers and make money for the magazines. They can also bring in patient revenue for doctors and their employers who promote them in news releases and on their websites.
For doctors on some of the top lists, the recognition can bring not only patients, but national or international visibility.
While the dollar value is hard to come by, some doctors say that these lists have attracted new patients to their practice.
Sarah St. Louis, MD, a physician manager of Associates in Urogynecology, is one of Orlando Style magazine’s Doctors of the Year and Orlando Family Magazine’s Top Doctors.
Several new patients have told her that they read about her in the magazines’ Top Doctor lists. “Urogynecology is not a well-known specialty – it’s a helpful way to get the word out about the women’s health specialty and what I do,” said Dr. St. Louis, an early career physician who started her practice in 2017.
The additional patient revenue has been worth the cost of displaying her profile in Orlando Style, which was about $800 for a half-page spread with her photo.
Top Doctor lists also work well for specialty practices whose patients can self-refer, such as plastic surgery, dermatology, orthopedics, gastroenterology, and geriatric medicine, said Andrea Eliscu, RN, founder and president of Medical Marketing in Orlando.
Being in a competitive market also matters. If a practice is the only one in town, those doctors may not need the publicity as much as doctors in an urban practice that faces stiff competition.
How do doctors get on these lists?
In most cases, doctors have to be nominated by their peers, a process that some say is flawed because it may shut out doctors who are less popular or well-connected.
Forty-eight regional magazines, including Chicago magazine and Philadelphia Magazine , partner with Castle Connolly to use their online Top Doctor database of more than 61,000 physicians in every major metropolitan area, said Steve Leibforth, managing director of Castle Connolly’s Top Doctors.
The company says it sends annual surveys to tens of thousands of practicing doctors asking them to nominate colleagues in their specialty. The nominated doctors are vetted by Castle Connolly’s physician-led research team on several criteria including professional qualifications, education, hospital and faculty appointments, research leadership, professional reputation and disciplinary history, and outcomes data when available, said Mr. Leibforth.
Washingtonian magazine says it sends annual online surveys to 13,500 physicians in the DC metro area asking them to nominate one colleague in their specialty. The top vote-getters in each of 39 categories are designated Top Doctors.
Orlando Family Magazine says its annual Top Doctor selections are based on reader polls and doctor nominations.
Consumers’ Research Council of America uses a point system based on each year the doctor has been in practice, education and continuing education, board certification, and membership in professional medical societies.
Doctors have many ways to promote that they’re listed as a “top” doctor. Dr. St. Louis takes advantage of the magazine’s free reprints, which she puts in her waiting room.
Others buy plaques to hang up in their waiting rooms or offices and announce the distinction on their websites, blogs, or social media. “They have to maximize the magazine distinction or it’s worthless,” said Ms. Eliscu.
Employers also like to spread the word when their doctors make it on “Top Doctor” lists.
“With Emory physicians making up nearly 50 percent of the list, that’s more than any other health system in Atlanta,” said an Emory University press release after nearly half of the university’s doctors made the Top Doctors list in Atlanta magazine.
Patients may be impressed: What about your peers?
Dr. St. Louis said that making some of these lists is less impressive than having a peer-reviewed journal article or receiving professional awards.
“Just because a physician is listed in a magazine as a ‘top doctor’ does not mean they are the best. There are far more medical, clinical, and scientific points to consider than just a pretty picture in a style magazine,” she said.
Wanda Filer, MD, MBA, who practiced family medicine until last year when she became chief medical officer for VaxCare in Orlando, said she ignores the many congratulatory letters in the mail announcing that she’s made one list or another.
“I don’t put much credence in the lists. I get notifications fairly often, and to me it always looks like they’re trying to sell a plaque. I’d rather let my work speak for itself.”
Arlen Meyers, MD, MBA, president and CEO of the Society of Physician Entrepreneurs and a paid strategic adviser to RYTE, a data-driven site for “best doctors” and “best hospitals,” said he received several of these “top doctor” awards when he was a professor of otolaryngology at the University of Colorado.
He has been critical of these awards for some time. “These doctor beauty pageants may be good for business but have little value for patients.”
He would like to see a new approach that is driven by data and what patients value. “If I have a lump in my thyroid, I want to know the best doctor to treat me based on outcomes data.”
He said a good rating system would include a data-driven approach based on treatment outcomes, publicly available data, price transparency, and patient values.
Whether a physician feels honored to be named a top physician or sees little value in it, most doctors are aware of the list’s marketing value for their practices and many choose to make use of it.
A version of this article first appeared on Medscape.com.
Thousands of doctors get a shout out every year when they make the “Top Doctor” lists in various magazines. Some may be your colleagues or competitors. Should you be concerned if you’re not on the list?
Best Doctor lists are clearly popular with readers and make money for the magazines. They can also bring in patient revenue for doctors and their employers who promote them in news releases and on their websites.
For doctors on some of the top lists, the recognition can bring not only patients, but national or international visibility.
While the dollar value is hard to come by, some doctors say that these lists have attracted new patients to their practice.
Sarah St. Louis, MD, a physician manager of Associates in Urogynecology, is one of Orlando Style magazine’s Doctors of the Year and Orlando Family Magazine’s Top Doctors.
Several new patients have told her that they read about her in the magazines’ Top Doctor lists. “Urogynecology is not a well-known specialty – it’s a helpful way to get the word out about the women’s health specialty and what I do,” said Dr. St. Louis, an early career physician who started her practice in 2017.
The additional patient revenue has been worth the cost of displaying her profile in Orlando Style, which was about $800 for a half-page spread with her photo.
Top Doctor lists also work well for specialty practices whose patients can self-refer, such as plastic surgery, dermatology, orthopedics, gastroenterology, and geriatric medicine, said Andrea Eliscu, RN, founder and president of Medical Marketing in Orlando.
Being in a competitive market also matters. If a practice is the only one in town, those doctors may not need the publicity as much as doctors in an urban practice that faces stiff competition.
How do doctors get on these lists?
In most cases, doctors have to be nominated by their peers, a process that some say is flawed because it may shut out doctors who are less popular or well-connected.
Forty-eight regional magazines, including Chicago magazine and Philadelphia Magazine , partner with Castle Connolly to use their online Top Doctor database of more than 61,000 physicians in every major metropolitan area, said Steve Leibforth, managing director of Castle Connolly’s Top Doctors.
The company says it sends annual surveys to tens of thousands of practicing doctors asking them to nominate colleagues in their specialty. The nominated doctors are vetted by Castle Connolly’s physician-led research team on several criteria including professional qualifications, education, hospital and faculty appointments, research leadership, professional reputation and disciplinary history, and outcomes data when available, said Mr. Leibforth.
Washingtonian magazine says it sends annual online surveys to 13,500 physicians in the DC metro area asking them to nominate one colleague in their specialty. The top vote-getters in each of 39 categories are designated Top Doctors.
Orlando Family Magazine says its annual Top Doctor selections are based on reader polls and doctor nominations.
Consumers’ Research Council of America uses a point system based on each year the doctor has been in practice, education and continuing education, board certification, and membership in professional medical societies.
Doctors have many ways to promote that they’re listed as a “top” doctor. Dr. St. Louis takes advantage of the magazine’s free reprints, which she puts in her waiting room.
Others buy plaques to hang up in their waiting rooms or offices and announce the distinction on their websites, blogs, or social media. “They have to maximize the magazine distinction or it’s worthless,” said Ms. Eliscu.
Employers also like to spread the word when their doctors make it on “Top Doctor” lists.
“With Emory physicians making up nearly 50 percent of the list, that’s more than any other health system in Atlanta,” said an Emory University press release after nearly half of the university’s doctors made the Top Doctors list in Atlanta magazine.
Patients may be impressed: What about your peers?
Dr. St. Louis said that making some of these lists is less impressive than having a peer-reviewed journal article or receiving professional awards.
“Just because a physician is listed in a magazine as a ‘top doctor’ does not mean they are the best. There are far more medical, clinical, and scientific points to consider than just a pretty picture in a style magazine,” she said.
Wanda Filer, MD, MBA, who practiced family medicine until last year when she became chief medical officer for VaxCare in Orlando, said she ignores the many congratulatory letters in the mail announcing that she’s made one list or another.
“I don’t put much credence in the lists. I get notifications fairly often, and to me it always looks like they’re trying to sell a plaque. I’d rather let my work speak for itself.”
Arlen Meyers, MD, MBA, president and CEO of the Society of Physician Entrepreneurs and a paid strategic adviser to RYTE, a data-driven site for “best doctors” and “best hospitals,” said he received several of these “top doctor” awards when he was a professor of otolaryngology at the University of Colorado.
He has been critical of these awards for some time. “These doctor beauty pageants may be good for business but have little value for patients.”
He would like to see a new approach that is driven by data and what patients value. “If I have a lump in my thyroid, I want to know the best doctor to treat me based on outcomes data.”
He said a good rating system would include a data-driven approach based on treatment outcomes, publicly available data, price transparency, and patient values.
Whether a physician feels honored to be named a top physician or sees little value in it, most doctors are aware of the list’s marketing value for their practices and many choose to make use of it.
A version of this article first appeared on Medscape.com.
Thousands of doctors get a shout out every year when they make the “Top Doctor” lists in various magazines. Some may be your colleagues or competitors. Should you be concerned if you’re not on the list?
Best Doctor lists are clearly popular with readers and make money for the magazines. They can also bring in patient revenue for doctors and their employers who promote them in news releases and on their websites.
For doctors on some of the top lists, the recognition can bring not only patients, but national or international visibility.
While the dollar value is hard to come by, some doctors say that these lists have attracted new patients to their practice.
Sarah St. Louis, MD, a physician manager of Associates in Urogynecology, is one of Orlando Style magazine’s Doctors of the Year and Orlando Family Magazine’s Top Doctors.
Several new patients have told her that they read about her in the magazines’ Top Doctor lists. “Urogynecology is not a well-known specialty – it’s a helpful way to get the word out about the women’s health specialty and what I do,” said Dr. St. Louis, an early career physician who started her practice in 2017.
The additional patient revenue has been worth the cost of displaying her profile in Orlando Style, which was about $800 for a half-page spread with her photo.
Top Doctor lists also work well for specialty practices whose patients can self-refer, such as plastic surgery, dermatology, orthopedics, gastroenterology, and geriatric medicine, said Andrea Eliscu, RN, founder and president of Medical Marketing in Orlando.
Being in a competitive market also matters. If a practice is the only one in town, those doctors may not need the publicity as much as doctors in an urban practice that faces stiff competition.
How do doctors get on these lists?
In most cases, doctors have to be nominated by their peers, a process that some say is flawed because it may shut out doctors who are less popular or well-connected.
Forty-eight regional magazines, including Chicago magazine and Philadelphia Magazine , partner with Castle Connolly to use their online Top Doctor database of more than 61,000 physicians in every major metropolitan area, said Steve Leibforth, managing director of Castle Connolly’s Top Doctors.
The company says it sends annual surveys to tens of thousands of practicing doctors asking them to nominate colleagues in their specialty. The nominated doctors are vetted by Castle Connolly’s physician-led research team on several criteria including professional qualifications, education, hospital and faculty appointments, research leadership, professional reputation and disciplinary history, and outcomes data when available, said Mr. Leibforth.
Washingtonian magazine says it sends annual online surveys to 13,500 physicians in the DC metro area asking them to nominate one colleague in their specialty. The top vote-getters in each of 39 categories are designated Top Doctors.
Orlando Family Magazine says its annual Top Doctor selections are based on reader polls and doctor nominations.
Consumers’ Research Council of America uses a point system based on each year the doctor has been in practice, education and continuing education, board certification, and membership in professional medical societies.
Doctors have many ways to promote that they’re listed as a “top” doctor. Dr. St. Louis takes advantage of the magazine’s free reprints, which she puts in her waiting room.
Others buy plaques to hang up in their waiting rooms or offices and announce the distinction on their websites, blogs, or social media. “They have to maximize the magazine distinction or it’s worthless,” said Ms. Eliscu.
Employers also like to spread the word when their doctors make it on “Top Doctor” lists.
“With Emory physicians making up nearly 50 percent of the list, that’s more than any other health system in Atlanta,” said an Emory University press release after nearly half of the university’s doctors made the Top Doctors list in Atlanta magazine.
Patients may be impressed: What about your peers?
Dr. St. Louis said that making some of these lists is less impressive than having a peer-reviewed journal article or receiving professional awards.
“Just because a physician is listed in a magazine as a ‘top doctor’ does not mean they are the best. There are far more medical, clinical, and scientific points to consider than just a pretty picture in a style magazine,” she said.
Wanda Filer, MD, MBA, who practiced family medicine until last year when she became chief medical officer for VaxCare in Orlando, said she ignores the many congratulatory letters in the mail announcing that she’s made one list or another.
“I don’t put much credence in the lists. I get notifications fairly often, and to me it always looks like they’re trying to sell a plaque. I’d rather let my work speak for itself.”
Arlen Meyers, MD, MBA, president and CEO of the Society of Physician Entrepreneurs and a paid strategic adviser to RYTE, a data-driven site for “best doctors” and “best hospitals,” said he received several of these “top doctor” awards when he was a professor of otolaryngology at the University of Colorado.
He has been critical of these awards for some time. “These doctor beauty pageants may be good for business but have little value for patients.”
He would like to see a new approach that is driven by data and what patients value. “If I have a lump in my thyroid, I want to know the best doctor to treat me based on outcomes data.”
He said a good rating system would include a data-driven approach based on treatment outcomes, publicly available data, price transparency, and patient values.
Whether a physician feels honored to be named a top physician or sees little value in it, most doctors are aware of the list’s marketing value for their practices and many choose to make use of it.
A version of this article first appeared on Medscape.com.
Is aspirin the best way to prevent blood clots after THA/TKA?
CHICAGO – Patients discharged to facilities rather than to home after total hip arthroplasty (THA) or total knee arthroplasty (TKA) may need more potent chemoprophylaxis than aspirin to prevent blood clots, new data suggest.
Researchers led by Stefano Muscatelli, MD, an orthopedist at Michigan Medicine, Ann Arbor, first aimed to determine whether there was an increase in risk of venous thromboembolism (VTE) in patients who were discharged to facilities such as a skilled nursing facility or inpatient rehabilitation facility, compared with those discharged to home after THA or TKA.
The second aim was to determine whether VTE risk differed between home- and non–home-discharge patients when stratified by the chemoprophylaxis prescribed to prevent VTE.
Findings were presented at the annual meeting of the American Academy of Orthopaedic Surgeons by coauthor Michael McHugh, MD, also an orthopedist at Michigan Medicine in Ann Arbor.
The agents were categorized in three groups: aspirin only; more aggressive anticoagulants, including warfarin, factor Xa inhibitor, direct thrombin inhibitor, low-molecular-weight heparin, pentasaccharide, or antiplatelet agents, with or without concurrent aspirin; and other regimens.
The researchers found that rates of VTE were higher among patients discharged to facilities.
Of 6,411 patients included in the study, the overall rate of VTE was 1.05%. Among home-discharge patients (n = 5445), rates of VTE were significantly lower than among patients discharged to facilities (n = 966) (0.83% vs. 2.26%; P < .001).
However, the researchers found there was no difference in VTE rates between non-home and home discharge in patients who received more aggressive chemoprophylaxis.
Among discharged patients who received only aspirin, rates of VTE among those discharged to home were significantly lower compared to those discharged to facilities (0.76% vs. 3.83%; P < .001).
“Smoking, BMI [body mass index], procedure type, and preoperative anticoagulation were not associated with the outcome of VTE,” Dr. McHugh said.
“Although we found VTE to continue to be an uncommon complication, non-home discharge is independently associated with higher rates of VTE. Patients should be encouraged to discharge home, but those discharged to non-home facilities after total joint arthroplasty should be considered for more potent chemoprophylaxis than aspirin,” he concluded.
Stuart J. Fischer, MD, with Summit (N.J.) Orthopaedics and Sports Medicine, who was not part of the study, told this news organization that he found the results inconclusive.
He said there is the potential for confounding because “the people who are sent to a facility after total hip or total knee are inherently less mobile and less able to take care of themselves, so they are at a higher risk for VTE. They are going to be more static.”
Dr. Fischer noted that over the past few years, there has been a movement away from anticoagulation with more aggressive agents toward aspirin, for several reasons. Providers don’t have to monitor aspirin use and can instruct patients to take it once or twice a day. Initial data seem to show that it protects well against VTE.
“The question is, in certain population of patients, is it enough? And that’s where the data are unclear,” Dr. Fischer said.
“It’s certainly a useful study, and we need to find out which methods of anticoagulation are most effective in each setting,” he said.
Limitations include that it was a retrospective review and that adverse events from more aggressive chemoprophylaxis agents were not assessed. Prophylactic regimens were chosen at the discretion of the treating surgeon.
The researchers excluded bilateral cases, conversion arthroplasty, hip hemiarthroplasty, unicompartmental knee arthroplasty, and deaths.
Dr. Muscatelli and Dr. McHugh reported no relevant financial relationships. A coauthor reported being a paid consultant for DePuy and Zimmer. Dr. Fischer reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
CHICAGO – Patients discharged to facilities rather than to home after total hip arthroplasty (THA) or total knee arthroplasty (TKA) may need more potent chemoprophylaxis than aspirin to prevent blood clots, new data suggest.
Researchers led by Stefano Muscatelli, MD, an orthopedist at Michigan Medicine, Ann Arbor, first aimed to determine whether there was an increase in risk of venous thromboembolism (VTE) in patients who were discharged to facilities such as a skilled nursing facility or inpatient rehabilitation facility, compared with those discharged to home after THA or TKA.
The second aim was to determine whether VTE risk differed between home- and non–home-discharge patients when stratified by the chemoprophylaxis prescribed to prevent VTE.
Findings were presented at the annual meeting of the American Academy of Orthopaedic Surgeons by coauthor Michael McHugh, MD, also an orthopedist at Michigan Medicine in Ann Arbor.
The agents were categorized in three groups: aspirin only; more aggressive anticoagulants, including warfarin, factor Xa inhibitor, direct thrombin inhibitor, low-molecular-weight heparin, pentasaccharide, or antiplatelet agents, with or without concurrent aspirin; and other regimens.
The researchers found that rates of VTE were higher among patients discharged to facilities.
Of 6,411 patients included in the study, the overall rate of VTE was 1.05%. Among home-discharge patients (n = 5445), rates of VTE were significantly lower than among patients discharged to facilities (n = 966) (0.83% vs. 2.26%; P < .001).
However, the researchers found there was no difference in VTE rates between non-home and home discharge in patients who received more aggressive chemoprophylaxis.
Among discharged patients who received only aspirin, rates of VTE among those discharged to home were significantly lower compared to those discharged to facilities (0.76% vs. 3.83%; P < .001).
“Smoking, BMI [body mass index], procedure type, and preoperative anticoagulation were not associated with the outcome of VTE,” Dr. McHugh said.
“Although we found VTE to continue to be an uncommon complication, non-home discharge is independently associated with higher rates of VTE. Patients should be encouraged to discharge home, but those discharged to non-home facilities after total joint arthroplasty should be considered for more potent chemoprophylaxis than aspirin,” he concluded.
Stuart J. Fischer, MD, with Summit (N.J.) Orthopaedics and Sports Medicine, who was not part of the study, told this news organization that he found the results inconclusive.
He said there is the potential for confounding because “the people who are sent to a facility after total hip or total knee are inherently less mobile and less able to take care of themselves, so they are at a higher risk for VTE. They are going to be more static.”
Dr. Fischer noted that over the past few years, there has been a movement away from anticoagulation with more aggressive agents toward aspirin, for several reasons. Providers don’t have to monitor aspirin use and can instruct patients to take it once or twice a day. Initial data seem to show that it protects well against VTE.
“The question is, in certain population of patients, is it enough? And that’s where the data are unclear,” Dr. Fischer said.
“It’s certainly a useful study, and we need to find out which methods of anticoagulation are most effective in each setting,” he said.
Limitations include that it was a retrospective review and that adverse events from more aggressive chemoprophylaxis agents were not assessed. Prophylactic regimens were chosen at the discretion of the treating surgeon.
The researchers excluded bilateral cases, conversion arthroplasty, hip hemiarthroplasty, unicompartmental knee arthroplasty, and deaths.
Dr. Muscatelli and Dr. McHugh reported no relevant financial relationships. A coauthor reported being a paid consultant for DePuy and Zimmer. Dr. Fischer reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
CHICAGO – Patients discharged to facilities rather than to home after total hip arthroplasty (THA) or total knee arthroplasty (TKA) may need more potent chemoprophylaxis than aspirin to prevent blood clots, new data suggest.
Researchers led by Stefano Muscatelli, MD, an orthopedist at Michigan Medicine, Ann Arbor, first aimed to determine whether there was an increase in risk of venous thromboembolism (VTE) in patients who were discharged to facilities such as a skilled nursing facility or inpatient rehabilitation facility, compared with those discharged to home after THA or TKA.
The second aim was to determine whether VTE risk differed between home- and non–home-discharge patients when stratified by the chemoprophylaxis prescribed to prevent VTE.
Findings were presented at the annual meeting of the American Academy of Orthopaedic Surgeons by coauthor Michael McHugh, MD, also an orthopedist at Michigan Medicine in Ann Arbor.
The agents were categorized in three groups: aspirin only; more aggressive anticoagulants, including warfarin, factor Xa inhibitor, direct thrombin inhibitor, low-molecular-weight heparin, pentasaccharide, or antiplatelet agents, with or without concurrent aspirin; and other regimens.
The researchers found that rates of VTE were higher among patients discharged to facilities.
Of 6,411 patients included in the study, the overall rate of VTE was 1.05%. Among home-discharge patients (n = 5445), rates of VTE were significantly lower than among patients discharged to facilities (n = 966) (0.83% vs. 2.26%; P < .001).
However, the researchers found there was no difference in VTE rates between non-home and home discharge in patients who received more aggressive chemoprophylaxis.
Among discharged patients who received only aspirin, rates of VTE among those discharged to home were significantly lower compared to those discharged to facilities (0.76% vs. 3.83%; P < .001).
“Smoking, BMI [body mass index], procedure type, and preoperative anticoagulation were not associated with the outcome of VTE,” Dr. McHugh said.
“Although we found VTE to continue to be an uncommon complication, non-home discharge is independently associated with higher rates of VTE. Patients should be encouraged to discharge home, but those discharged to non-home facilities after total joint arthroplasty should be considered for more potent chemoprophylaxis than aspirin,” he concluded.
Stuart J. Fischer, MD, with Summit (N.J.) Orthopaedics and Sports Medicine, who was not part of the study, told this news organization that he found the results inconclusive.
He said there is the potential for confounding because “the people who are sent to a facility after total hip or total knee are inherently less mobile and less able to take care of themselves, so they are at a higher risk for VTE. They are going to be more static.”
Dr. Fischer noted that over the past few years, there has been a movement away from anticoagulation with more aggressive agents toward aspirin, for several reasons. Providers don’t have to monitor aspirin use and can instruct patients to take it once or twice a day. Initial data seem to show that it protects well against VTE.
“The question is, in certain population of patients, is it enough? And that’s where the data are unclear,” Dr. Fischer said.
“It’s certainly a useful study, and we need to find out which methods of anticoagulation are most effective in each setting,” he said.
Limitations include that it was a retrospective review and that adverse events from more aggressive chemoprophylaxis agents were not assessed. Prophylactic regimens were chosen at the discretion of the treating surgeon.
The researchers excluded bilateral cases, conversion arthroplasty, hip hemiarthroplasty, unicompartmental knee arthroplasty, and deaths.
Dr. Muscatelli and Dr. McHugh reported no relevant financial relationships. A coauthor reported being a paid consultant for DePuy and Zimmer. Dr. Fischer reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
AT AAOS 2022
As FDA OKs another COVID booster, some experts question need
, even though many top infectious disease experts questioned the need before the agency’s decision.
The FDA granted emergency use authorization for both Pfizer and Moderna to offer the second booster – and fourth shot overall – for adults over 50 as well as those over 18 with compromised immune systems.
The Centers for Control and Prevention must still sign off before those doses start reaching American arms. That approval could come at any time.
“The general consensus, certainly the CDC’s consensus, is that the current vaccines are still really quite effective against Omicron and this new BA.2 variant in keeping people out of the hospital, and preventing the development of severe disease,” William Schaffner, MD, an infectious disease specialist at Vanderbilt University in Nashville said prior to the FDA’s announcement March 29.
Of the 217.4 million Americans who are “fully vaccinated,” i.e., received two doses of either Pfizer or Moderna’s vaccines or one dose of the Johnson & Johnson vaccine, only 45% have also received a booster shot, according to the CDC.
“Given that, there’s no need at the moment for the general population to get a fourth inoculation,” Dr. Schaffner says. “Our current focus ought to be on making sure that as many people as possible get that [first] booster who are eligible.”
Monica Gandhi, MD, an infectious disease specialist at the University of California, San Francisco, agreed that another booster for everyone was unnecessary. The only people who would need a fourth shot (or third, if they had the Johnson & Johnson vaccine initially) are those over age 65 or 70 years, Dr. Gandhi says.
“Older people need those antibodies up high because they’re more susceptible to severe breakthroughs,” she said, also before the latest development.
To boost or not to boost
Daniel Kuritzkes, MD, chief of infectious diseases at Brigham & Women’s Hospital in Boston, said the timing of a booster and who should be eligible depends on what the nation is trying to achieve with its vaccination strategy.
“Is the goal to prevent any symptomatic infection with COVID-19, is the goal to prevent the spread of COVID-19, or is the goal to prevent severe disease that requires hospitalization?” asked Dr. Kuritzkes.
The current vaccine — with a booster — has prevented severe disease, he said.
An Israeli study showed, for instance, that a third Pfizer dose was 93% effective against hospitalization, 92% effective against severe illness, and 81% effective against death.
A just-published study in the New England Journal of Medicine found that a booster of the Pfizer vaccine was 95% effective against COVID-19 infection and that it did not raise any new safety issues.
A small Israeli study, also published in NEJM, of a fourth Pfizer dose given to health care workers found that it prevented symptomatic infection and illness, but that it was much less effective than previous doses — maybe 65% effective against symptomatic illness, the authors write.
Giving Americans another booster now — which has been shown to lose some effectiveness after about 4 months — means it might not offer protection this fall and winter, when there could be a seasonal surge of the virus, Dr. Kuritzkes says.
And, even if people receive boosters every few months, they are still likely to get a mild respiratory virus infection, he said.
“I’m pretty convinced that we cannot boost ourselves out of this pandemic,” said Dr. Kuritzkes. “We need to first of all ensure there’s global immunization so that all the people who have not been vaccinated at all get vaccinated. That’s far more important than boosting people a fourth time.”
Booster confusion
The April 6 FDA meeting of the agency’s Vaccines and Related Biological Products Advisory Committee comes as the two major COVID vaccine makers — Pfizer and Moderna — have applied for emergency use authorization for an additional booster.
Pfizer had asked for authorization for a fourth shot in patients over age 65 years, while Moderna wanted a booster to be available to all Americans over 18. The FDA instead granted authorization to both companies for those over 50 and anyone 18 or older who is immunocompromised.
What this means for the committee’s April 6 meeting is not clear. The original agenda says the committee will consider the evidence on safety and effectiveness of the additional vaccine doses and discuss how to set up a process — similar to that used for the influenza vaccine — to be able to determine the makeup of COVID vaccines as new variants emerge. That could lay the groundwork for an annual COVID shot, if needed.
The FDA advisers will not make recommendations nor vote on whether — and which — Americans should get a COVID booster. That is the job of the CDC’s Advisory Committee on Immunization Practices (ACIP).
The last time a booster was considered, CDC Director Rochelle Walensky, MD, overrode the committee and recommended that all Americans — not just older individuals — get an additional COVID shot, which became the first booster.
That past action worries Dr. Gandhi, who calls it confusing, and says it may have contributed to the fact that less than half of Americans have since chosen to get a booster.
Dr. Schaffner says he expects the FDA to authorize emergency use for fourth doses of the Pfizer and Moderna vaccines, but he doesn’t think the CDC committee will recommend routine use. As was seen before, however, the CDC director does not have to follow the committee’s advice.
The members of ACIP “might be more conservative or narrower in scope in terms of recommending who needs to be boosted and when boosting is appropriate,” Dr. Kuritzkes says.
Dr. Gandhi says she’s concerned the FDA’s deliberations could be swayed by Moderna and Pfizer’s influence and that “pharmaceutical companies are going to have more of a say than they should in the scientific process.”
There are similar worries for Dr. Schaffner. He says he’s “a bit grumpy” that the vaccine makers have been using press releases to argue for boosters.
“Press releases are no way to make vaccine recommendations,” Dr. Schaffner said, adding that he “would advise [vaccine makers] to sit down and be quiet and let the FDA and CDC advisory committee do their thing.”
Moderna Chief Medical Officer Paul Burton, MD, however, told WebMD last week that the signs point to why a fourth shot may be needed.
“We see waning of effectiveness, antibody levels come down, and certainly effectiveness against Omicron comes down in 3 to 6 months,” Burton said. “The natural history, from what we’re seeing around the world, is that BA.2 is definitely here, it’s highly transmissible, and I think we are going to get an additional wave of BA.2 here in the United States.”
Another wave is coming, he said, and “I think there will be waning of effectiveness. We need to be prepared for that, so that’s why we need the fourth dose.”
Supply issues?
Meanwhile, the United Kingdom has begun offering boosters to anyone over 75, and Sweden’s health authority has recommended a fourth shot to people over age 80.
That puts pressure on the United States — at least on its politicians and policymakers — to, in a sense, keep up, said the infectious disease specialists.
Indeed, the White House has been keeping fourth shots in the news, warning that it is running out of money to ensure that all Americans would have access to one, if recommended.
On March 23, outgoing White House COVID-19 Response Coordinator Jeff Zients said the federal government had enough vaccine for the immunocompromised to get a fourth dose “and, if authorized in the coming weeks, enough supply for fourth doses for our most vulnerable, including seniors.”
But he warned that without congressional approval of a COVID-19 funding package, “We can’t procure the necessary vaccine supply to support fourth shots for all Americans.”
Mr. Zients also noted that other countries, including Japan, Vietnam, and the Philippines had already secured future booster doses and added, “We should be securing additional supply right now.”
Dr. Schaffner says that while it would be nice to “have a booster on the shelf,” the United States needs to put more effort into creating a globally-coordinated process for ensuring that vaccines match circulating strains and that they are manufactured on a timely basis.
He says he and others “have been reminding the public that the COVID pandemic may indeed be diminishing and moving into the endemic, but that doesn’t mean COVID is over or finished or disappeared.”
Dr. Schaffner says that it may be that “perhaps we’d need a periodic reminder to our immune system to remain protected. In other words, we might have to get boosted perhaps annually like we do with influenza.”
A version of this article first appeared on WebMD.com.
, even though many top infectious disease experts questioned the need before the agency’s decision.
The FDA granted emergency use authorization for both Pfizer and Moderna to offer the second booster – and fourth shot overall – for adults over 50 as well as those over 18 with compromised immune systems.
The Centers for Control and Prevention must still sign off before those doses start reaching American arms. That approval could come at any time.
“The general consensus, certainly the CDC’s consensus, is that the current vaccines are still really quite effective against Omicron and this new BA.2 variant in keeping people out of the hospital, and preventing the development of severe disease,” William Schaffner, MD, an infectious disease specialist at Vanderbilt University in Nashville said prior to the FDA’s announcement March 29.
Of the 217.4 million Americans who are “fully vaccinated,” i.e., received two doses of either Pfizer or Moderna’s vaccines or one dose of the Johnson & Johnson vaccine, only 45% have also received a booster shot, according to the CDC.
“Given that, there’s no need at the moment for the general population to get a fourth inoculation,” Dr. Schaffner says. “Our current focus ought to be on making sure that as many people as possible get that [first] booster who are eligible.”
Monica Gandhi, MD, an infectious disease specialist at the University of California, San Francisco, agreed that another booster for everyone was unnecessary. The only people who would need a fourth shot (or third, if they had the Johnson & Johnson vaccine initially) are those over age 65 or 70 years, Dr. Gandhi says.
“Older people need those antibodies up high because they’re more susceptible to severe breakthroughs,” she said, also before the latest development.
To boost or not to boost
Daniel Kuritzkes, MD, chief of infectious diseases at Brigham & Women’s Hospital in Boston, said the timing of a booster and who should be eligible depends on what the nation is trying to achieve with its vaccination strategy.
“Is the goal to prevent any symptomatic infection with COVID-19, is the goal to prevent the spread of COVID-19, or is the goal to prevent severe disease that requires hospitalization?” asked Dr. Kuritzkes.
The current vaccine — with a booster — has prevented severe disease, he said.
An Israeli study showed, for instance, that a third Pfizer dose was 93% effective against hospitalization, 92% effective against severe illness, and 81% effective against death.
A just-published study in the New England Journal of Medicine found that a booster of the Pfizer vaccine was 95% effective against COVID-19 infection and that it did not raise any new safety issues.
A small Israeli study, also published in NEJM, of a fourth Pfizer dose given to health care workers found that it prevented symptomatic infection and illness, but that it was much less effective than previous doses — maybe 65% effective against symptomatic illness, the authors write.
Giving Americans another booster now — which has been shown to lose some effectiveness after about 4 months — means it might not offer protection this fall and winter, when there could be a seasonal surge of the virus, Dr. Kuritzkes says.
And, even if people receive boosters every few months, they are still likely to get a mild respiratory virus infection, he said.
“I’m pretty convinced that we cannot boost ourselves out of this pandemic,” said Dr. Kuritzkes. “We need to first of all ensure there’s global immunization so that all the people who have not been vaccinated at all get vaccinated. That’s far more important than boosting people a fourth time.”
Booster confusion
The April 6 FDA meeting of the agency’s Vaccines and Related Biological Products Advisory Committee comes as the two major COVID vaccine makers — Pfizer and Moderna — have applied for emergency use authorization for an additional booster.
Pfizer had asked for authorization for a fourth shot in patients over age 65 years, while Moderna wanted a booster to be available to all Americans over 18. The FDA instead granted authorization to both companies for those over 50 and anyone 18 or older who is immunocompromised.
What this means for the committee’s April 6 meeting is not clear. The original agenda says the committee will consider the evidence on safety and effectiveness of the additional vaccine doses and discuss how to set up a process — similar to that used for the influenza vaccine — to be able to determine the makeup of COVID vaccines as new variants emerge. That could lay the groundwork for an annual COVID shot, if needed.
The FDA advisers will not make recommendations nor vote on whether — and which — Americans should get a COVID booster. That is the job of the CDC’s Advisory Committee on Immunization Practices (ACIP).
The last time a booster was considered, CDC Director Rochelle Walensky, MD, overrode the committee and recommended that all Americans — not just older individuals — get an additional COVID shot, which became the first booster.
That past action worries Dr. Gandhi, who calls it confusing, and says it may have contributed to the fact that less than half of Americans have since chosen to get a booster.
Dr. Schaffner says he expects the FDA to authorize emergency use for fourth doses of the Pfizer and Moderna vaccines, but he doesn’t think the CDC committee will recommend routine use. As was seen before, however, the CDC director does not have to follow the committee’s advice.
The members of ACIP “might be more conservative or narrower in scope in terms of recommending who needs to be boosted and when boosting is appropriate,” Dr. Kuritzkes says.
Dr. Gandhi says she’s concerned the FDA’s deliberations could be swayed by Moderna and Pfizer’s influence and that “pharmaceutical companies are going to have more of a say than they should in the scientific process.”
There are similar worries for Dr. Schaffner. He says he’s “a bit grumpy” that the vaccine makers have been using press releases to argue for boosters.
“Press releases are no way to make vaccine recommendations,” Dr. Schaffner said, adding that he “would advise [vaccine makers] to sit down and be quiet and let the FDA and CDC advisory committee do their thing.”
Moderna Chief Medical Officer Paul Burton, MD, however, told WebMD last week that the signs point to why a fourth shot may be needed.
“We see waning of effectiveness, antibody levels come down, and certainly effectiveness against Omicron comes down in 3 to 6 months,” Burton said. “The natural history, from what we’re seeing around the world, is that BA.2 is definitely here, it’s highly transmissible, and I think we are going to get an additional wave of BA.2 here in the United States.”
Another wave is coming, he said, and “I think there will be waning of effectiveness. We need to be prepared for that, so that’s why we need the fourth dose.”
Supply issues?
Meanwhile, the United Kingdom has begun offering boosters to anyone over 75, and Sweden’s health authority has recommended a fourth shot to people over age 80.
That puts pressure on the United States — at least on its politicians and policymakers — to, in a sense, keep up, said the infectious disease specialists.
Indeed, the White House has been keeping fourth shots in the news, warning that it is running out of money to ensure that all Americans would have access to one, if recommended.
On March 23, outgoing White House COVID-19 Response Coordinator Jeff Zients said the federal government had enough vaccine for the immunocompromised to get a fourth dose “and, if authorized in the coming weeks, enough supply for fourth doses for our most vulnerable, including seniors.”
But he warned that without congressional approval of a COVID-19 funding package, “We can’t procure the necessary vaccine supply to support fourth shots for all Americans.”
Mr. Zients also noted that other countries, including Japan, Vietnam, and the Philippines had already secured future booster doses and added, “We should be securing additional supply right now.”
Dr. Schaffner says that while it would be nice to “have a booster on the shelf,” the United States needs to put more effort into creating a globally-coordinated process for ensuring that vaccines match circulating strains and that they are manufactured on a timely basis.
He says he and others “have been reminding the public that the COVID pandemic may indeed be diminishing and moving into the endemic, but that doesn’t mean COVID is over or finished or disappeared.”
Dr. Schaffner says that it may be that “perhaps we’d need a periodic reminder to our immune system to remain protected. In other words, we might have to get boosted perhaps annually like we do with influenza.”
A version of this article first appeared on WebMD.com.
, even though many top infectious disease experts questioned the need before the agency’s decision.
The FDA granted emergency use authorization for both Pfizer and Moderna to offer the second booster – and fourth shot overall – for adults over 50 as well as those over 18 with compromised immune systems.
The Centers for Control and Prevention must still sign off before those doses start reaching American arms. That approval could come at any time.
“The general consensus, certainly the CDC’s consensus, is that the current vaccines are still really quite effective against Omicron and this new BA.2 variant in keeping people out of the hospital, and preventing the development of severe disease,” William Schaffner, MD, an infectious disease specialist at Vanderbilt University in Nashville said prior to the FDA’s announcement March 29.
Of the 217.4 million Americans who are “fully vaccinated,” i.e., received two doses of either Pfizer or Moderna’s vaccines or one dose of the Johnson & Johnson vaccine, only 45% have also received a booster shot, according to the CDC.
“Given that, there’s no need at the moment for the general population to get a fourth inoculation,” Dr. Schaffner says. “Our current focus ought to be on making sure that as many people as possible get that [first] booster who are eligible.”
Monica Gandhi, MD, an infectious disease specialist at the University of California, San Francisco, agreed that another booster for everyone was unnecessary. The only people who would need a fourth shot (or third, if they had the Johnson & Johnson vaccine initially) are those over age 65 or 70 years, Dr. Gandhi says.
“Older people need those antibodies up high because they’re more susceptible to severe breakthroughs,” she said, also before the latest development.
To boost or not to boost
Daniel Kuritzkes, MD, chief of infectious diseases at Brigham & Women’s Hospital in Boston, said the timing of a booster and who should be eligible depends on what the nation is trying to achieve with its vaccination strategy.
“Is the goal to prevent any symptomatic infection with COVID-19, is the goal to prevent the spread of COVID-19, or is the goal to prevent severe disease that requires hospitalization?” asked Dr. Kuritzkes.
The current vaccine — with a booster — has prevented severe disease, he said.
An Israeli study showed, for instance, that a third Pfizer dose was 93% effective against hospitalization, 92% effective against severe illness, and 81% effective against death.
A just-published study in the New England Journal of Medicine found that a booster of the Pfizer vaccine was 95% effective against COVID-19 infection and that it did not raise any new safety issues.
A small Israeli study, also published in NEJM, of a fourth Pfizer dose given to health care workers found that it prevented symptomatic infection and illness, but that it was much less effective than previous doses — maybe 65% effective against symptomatic illness, the authors write.
Giving Americans another booster now — which has been shown to lose some effectiveness after about 4 months — means it might not offer protection this fall and winter, when there could be a seasonal surge of the virus, Dr. Kuritzkes says.
And, even if people receive boosters every few months, they are still likely to get a mild respiratory virus infection, he said.
“I’m pretty convinced that we cannot boost ourselves out of this pandemic,” said Dr. Kuritzkes. “We need to first of all ensure there’s global immunization so that all the people who have not been vaccinated at all get vaccinated. That’s far more important than boosting people a fourth time.”
Booster confusion
The April 6 FDA meeting of the agency’s Vaccines and Related Biological Products Advisory Committee comes as the two major COVID vaccine makers — Pfizer and Moderna — have applied for emergency use authorization for an additional booster.
Pfizer had asked for authorization for a fourth shot in patients over age 65 years, while Moderna wanted a booster to be available to all Americans over 18. The FDA instead granted authorization to both companies for those over 50 and anyone 18 or older who is immunocompromised.
What this means for the committee’s April 6 meeting is not clear. The original agenda says the committee will consider the evidence on safety and effectiveness of the additional vaccine doses and discuss how to set up a process — similar to that used for the influenza vaccine — to be able to determine the makeup of COVID vaccines as new variants emerge. That could lay the groundwork for an annual COVID shot, if needed.
The FDA advisers will not make recommendations nor vote on whether — and which — Americans should get a COVID booster. That is the job of the CDC’s Advisory Committee on Immunization Practices (ACIP).
The last time a booster was considered, CDC Director Rochelle Walensky, MD, overrode the committee and recommended that all Americans — not just older individuals — get an additional COVID shot, which became the first booster.
That past action worries Dr. Gandhi, who calls it confusing, and says it may have contributed to the fact that less than half of Americans have since chosen to get a booster.
Dr. Schaffner says he expects the FDA to authorize emergency use for fourth doses of the Pfizer and Moderna vaccines, but he doesn’t think the CDC committee will recommend routine use. As was seen before, however, the CDC director does not have to follow the committee’s advice.
The members of ACIP “might be more conservative or narrower in scope in terms of recommending who needs to be boosted and when boosting is appropriate,” Dr. Kuritzkes says.
Dr. Gandhi says she’s concerned the FDA’s deliberations could be swayed by Moderna and Pfizer’s influence and that “pharmaceutical companies are going to have more of a say than they should in the scientific process.”
There are similar worries for Dr. Schaffner. He says he’s “a bit grumpy” that the vaccine makers have been using press releases to argue for boosters.
“Press releases are no way to make vaccine recommendations,” Dr. Schaffner said, adding that he “would advise [vaccine makers] to sit down and be quiet and let the FDA and CDC advisory committee do their thing.”
Moderna Chief Medical Officer Paul Burton, MD, however, told WebMD last week that the signs point to why a fourth shot may be needed.
“We see waning of effectiveness, antibody levels come down, and certainly effectiveness against Omicron comes down in 3 to 6 months,” Burton said. “The natural history, from what we’re seeing around the world, is that BA.2 is definitely here, it’s highly transmissible, and I think we are going to get an additional wave of BA.2 here in the United States.”
Another wave is coming, he said, and “I think there will be waning of effectiveness. We need to be prepared for that, so that’s why we need the fourth dose.”
Supply issues?
Meanwhile, the United Kingdom has begun offering boosters to anyone over 75, and Sweden’s health authority has recommended a fourth shot to people over age 80.
That puts pressure on the United States — at least on its politicians and policymakers — to, in a sense, keep up, said the infectious disease specialists.
Indeed, the White House has been keeping fourth shots in the news, warning that it is running out of money to ensure that all Americans would have access to one, if recommended.
On March 23, outgoing White House COVID-19 Response Coordinator Jeff Zients said the federal government had enough vaccine for the immunocompromised to get a fourth dose “and, if authorized in the coming weeks, enough supply for fourth doses for our most vulnerable, including seniors.”
But he warned that without congressional approval of a COVID-19 funding package, “We can’t procure the necessary vaccine supply to support fourth shots for all Americans.”
Mr. Zients also noted that other countries, including Japan, Vietnam, and the Philippines had already secured future booster doses and added, “We should be securing additional supply right now.”
Dr. Schaffner says that while it would be nice to “have a booster on the shelf,” the United States needs to put more effort into creating a globally-coordinated process for ensuring that vaccines match circulating strains and that they are manufactured on a timely basis.
He says he and others “have been reminding the public that the COVID pandemic may indeed be diminishing and moving into the endemic, but that doesn’t mean COVID is over or finished or disappeared.”
Dr. Schaffner says that it may be that “perhaps we’d need a periodic reminder to our immune system to remain protected. In other words, we might have to get boosted perhaps annually like we do with influenza.”
A version of this article first appeared on WebMD.com.
Medical cannabis may cut opioid use for back pain, OA
CHICAGO – Access to medical cannabis (MC) cut opioid prescriptions for patients with chronic noncancer back pain and patients with osteoarthritis, according to preliminary data presented at the annual meeting of the American Academy of Orthopaedic Surgeons.
For those with chronic back pain, the average morphine milligram equivalents (MME) per day dropped from 15.1 to 11.0 (n = 186; P < .01). More than one-third of the patients (38.7%) stopped taking morphine after they filled prescriptions for medical cannabis.
Opioid prescriptions were filled 6 months before access to MC and then were compared with 6 months after access to MC.
In analyzing subgroups, the researchers found that patients who started at less than 15 MME/day and more than 15 MME/day showed significant decreases after filling the MC prescription.
Almost half (48.5%) of the patients in the group that started at less than 15 MME daily dropped to 0 MME/day, and 13.5% of patients who were getting more than 15 MME/day stopped using opioids.
Data on filled opioid prescriptions were gathered from a Prescription Drug Monitoring Program (PDMP) system for patients diagnosed with chronic musculoskeletal noncancer back pain who were eligible for MC access between February 2018 and July 2019.
Medical cannabis has shown benefit in treating chronic pain, but evidence has been limited on whether it can reduce opioid use, which can lead to substance abuse, addiction, overdose, and death, the researchers noted.
Researchers found that using MC via multiple routes of administration seemed to be important.
Patients who used only a single administration route showed a statistically insignificant decrease in MME/day from 20.0 to 15.1 (n = 68; P = .054), whereas patients who used two or more routes showed a significant decrease from 13.2 to 9.5 (n = 76; P < .01).
“We have many patients who are benefiting from a single route of delivery for chronic orthopedic pain,” Ari Greis, DO, a physical medicine and rehabilitation specialist in Bryn Mawr, Pa., and a coauthor of the MC studies for both back pain and OA, said in an interview. “However, our data shows a greater reduction in opioid consumption in patients using more than one route of delivery.”
He said delivery modes in the studies included vaporized cannabis oil or flower; sublingual tinctures; capsules or tablets; and topical lotions, creams, and salves.
Dr. Greis is the director of the medical cannabis department at Rothman Orthopaedic Institute in Bryn Mawr, and is a senior fellow in the Institute of Emerging Health Professions and the Lambert Center for the Study of Medicinal Cannabis and Hemp, both in Philadelphia.
Medical cannabis also reduces opioids for OA
The same team of researchers, using the data from the PDMP system, showed that medical cannabis also helped reduce opioid use for osteoarthritis.
For patients using opioids for OA, there was a significant decrease in average MME/day of prescriptions filled by patients following MC access – from 18.2 to 9.8 (n = 40; P < .05). The average drop in MME/day was 46.3%. The percentage of patients who stopped using opioids was 37.5%. Pain score on a 0-10 visual analog scale decreased significantly from 6.6 (n = 36) to 5.0 (n = 26; P < .01) at 3 months and 5.4 (n = 16; P < .05) at 6 months.
Gary Stewart, MD, an orthopedic surgeon in Morrow, Ga., who was not part of the studies, told this news organization that the studies offer good preliminary data to offer help with the opioid issue.
“I sometimes feel that we, as orthopedic surgeons and physicians in general, are working with one hand behind our back. We’re taking something that is a heroin or morphine derivative and giving it to our patients when we know it has a high risk of building tolerance and addiction. But at the same time, we have no alternative,” he said.
He said it’s important to remember the results from the relatively small study are preliminary and observational. People used different forms and amounts of MC and the data show only that prescriptions were filled, but not whether the cannabis was used. Prospective, controlled studies where opioids go head-to-head with MC are needed, he said.
“Still, this can lead us to more studies to give us an option [apart from] an opioid that we know is highly addictive,” he said.
Dr. Stewart is a member of the AAOS Opioid Task Force. Dr. Greis and several coauthors have disclosed no relevant financial relationships, and other coauthors report financial ties to companies unrelated to the research presented.
A version of this article first appeared on Medscape.com.
CHICAGO – Access to medical cannabis (MC) cut opioid prescriptions for patients with chronic noncancer back pain and patients with osteoarthritis, according to preliminary data presented at the annual meeting of the American Academy of Orthopaedic Surgeons.
For those with chronic back pain, the average morphine milligram equivalents (MME) per day dropped from 15.1 to 11.0 (n = 186; P < .01). More than one-third of the patients (38.7%) stopped taking morphine after they filled prescriptions for medical cannabis.
Opioid prescriptions were filled 6 months before access to MC and then were compared with 6 months after access to MC.
In analyzing subgroups, the researchers found that patients who started at less than 15 MME/day and more than 15 MME/day showed significant decreases after filling the MC prescription.
Almost half (48.5%) of the patients in the group that started at less than 15 MME daily dropped to 0 MME/day, and 13.5% of patients who were getting more than 15 MME/day stopped using opioids.
Data on filled opioid prescriptions were gathered from a Prescription Drug Monitoring Program (PDMP) system for patients diagnosed with chronic musculoskeletal noncancer back pain who were eligible for MC access between February 2018 and July 2019.
Medical cannabis has shown benefit in treating chronic pain, but evidence has been limited on whether it can reduce opioid use, which can lead to substance abuse, addiction, overdose, and death, the researchers noted.
Researchers found that using MC via multiple routes of administration seemed to be important.
Patients who used only a single administration route showed a statistically insignificant decrease in MME/day from 20.0 to 15.1 (n = 68; P = .054), whereas patients who used two or more routes showed a significant decrease from 13.2 to 9.5 (n = 76; P < .01).
“We have many patients who are benefiting from a single route of delivery for chronic orthopedic pain,” Ari Greis, DO, a physical medicine and rehabilitation specialist in Bryn Mawr, Pa., and a coauthor of the MC studies for both back pain and OA, said in an interview. “However, our data shows a greater reduction in opioid consumption in patients using more than one route of delivery.”
He said delivery modes in the studies included vaporized cannabis oil or flower; sublingual tinctures; capsules or tablets; and topical lotions, creams, and salves.
Dr. Greis is the director of the medical cannabis department at Rothman Orthopaedic Institute in Bryn Mawr, and is a senior fellow in the Institute of Emerging Health Professions and the Lambert Center for the Study of Medicinal Cannabis and Hemp, both in Philadelphia.
Medical cannabis also reduces opioids for OA
The same team of researchers, using the data from the PDMP system, showed that medical cannabis also helped reduce opioid use for osteoarthritis.
For patients using opioids for OA, there was a significant decrease in average MME/day of prescriptions filled by patients following MC access – from 18.2 to 9.8 (n = 40; P < .05). The average drop in MME/day was 46.3%. The percentage of patients who stopped using opioids was 37.5%. Pain score on a 0-10 visual analog scale decreased significantly from 6.6 (n = 36) to 5.0 (n = 26; P < .01) at 3 months and 5.4 (n = 16; P < .05) at 6 months.
Gary Stewart, MD, an orthopedic surgeon in Morrow, Ga., who was not part of the studies, told this news organization that the studies offer good preliminary data to offer help with the opioid issue.
“I sometimes feel that we, as orthopedic surgeons and physicians in general, are working with one hand behind our back. We’re taking something that is a heroin or morphine derivative and giving it to our patients when we know it has a high risk of building tolerance and addiction. But at the same time, we have no alternative,” he said.
He said it’s important to remember the results from the relatively small study are preliminary and observational. People used different forms and amounts of MC and the data show only that prescriptions were filled, but not whether the cannabis was used. Prospective, controlled studies where opioids go head-to-head with MC are needed, he said.
“Still, this can lead us to more studies to give us an option [apart from] an opioid that we know is highly addictive,” he said.
Dr. Stewart is a member of the AAOS Opioid Task Force. Dr. Greis and several coauthors have disclosed no relevant financial relationships, and other coauthors report financial ties to companies unrelated to the research presented.
A version of this article first appeared on Medscape.com.
CHICAGO – Access to medical cannabis (MC) cut opioid prescriptions for patients with chronic noncancer back pain and patients with osteoarthritis, according to preliminary data presented at the annual meeting of the American Academy of Orthopaedic Surgeons.
For those with chronic back pain, the average morphine milligram equivalents (MME) per day dropped from 15.1 to 11.0 (n = 186; P < .01). More than one-third of the patients (38.7%) stopped taking morphine after they filled prescriptions for medical cannabis.
Opioid prescriptions were filled 6 months before access to MC and then were compared with 6 months after access to MC.
In analyzing subgroups, the researchers found that patients who started at less than 15 MME/day and more than 15 MME/day showed significant decreases after filling the MC prescription.
Almost half (48.5%) of the patients in the group that started at less than 15 MME daily dropped to 0 MME/day, and 13.5% of patients who were getting more than 15 MME/day stopped using opioids.
Data on filled opioid prescriptions were gathered from a Prescription Drug Monitoring Program (PDMP) system for patients diagnosed with chronic musculoskeletal noncancer back pain who were eligible for MC access between February 2018 and July 2019.
Medical cannabis has shown benefit in treating chronic pain, but evidence has been limited on whether it can reduce opioid use, which can lead to substance abuse, addiction, overdose, and death, the researchers noted.
Researchers found that using MC via multiple routes of administration seemed to be important.
Patients who used only a single administration route showed a statistically insignificant decrease in MME/day from 20.0 to 15.1 (n = 68; P = .054), whereas patients who used two or more routes showed a significant decrease from 13.2 to 9.5 (n = 76; P < .01).
“We have many patients who are benefiting from a single route of delivery for chronic orthopedic pain,” Ari Greis, DO, a physical medicine and rehabilitation specialist in Bryn Mawr, Pa., and a coauthor of the MC studies for both back pain and OA, said in an interview. “However, our data shows a greater reduction in opioid consumption in patients using more than one route of delivery.”
He said delivery modes in the studies included vaporized cannabis oil or flower; sublingual tinctures; capsules or tablets; and topical lotions, creams, and salves.
Dr. Greis is the director of the medical cannabis department at Rothman Orthopaedic Institute in Bryn Mawr, and is a senior fellow in the Institute of Emerging Health Professions and the Lambert Center for the Study of Medicinal Cannabis and Hemp, both in Philadelphia.
Medical cannabis also reduces opioids for OA
The same team of researchers, using the data from the PDMP system, showed that medical cannabis also helped reduce opioid use for osteoarthritis.
For patients using opioids for OA, there was a significant decrease in average MME/day of prescriptions filled by patients following MC access – from 18.2 to 9.8 (n = 40; P < .05). The average drop in MME/day was 46.3%. The percentage of patients who stopped using opioids was 37.5%. Pain score on a 0-10 visual analog scale decreased significantly from 6.6 (n = 36) to 5.0 (n = 26; P < .01) at 3 months and 5.4 (n = 16; P < .05) at 6 months.
Gary Stewart, MD, an orthopedic surgeon in Morrow, Ga., who was not part of the studies, told this news organization that the studies offer good preliminary data to offer help with the opioid issue.
“I sometimes feel that we, as orthopedic surgeons and physicians in general, are working with one hand behind our back. We’re taking something that is a heroin or morphine derivative and giving it to our patients when we know it has a high risk of building tolerance and addiction. But at the same time, we have no alternative,” he said.
He said it’s important to remember the results from the relatively small study are preliminary and observational. People used different forms and amounts of MC and the data show only that prescriptions were filled, but not whether the cannabis was used. Prospective, controlled studies where opioids go head-to-head with MC are needed, he said.
“Still, this can lead us to more studies to give us an option [apart from] an opioid that we know is highly addictive,” he said.
Dr. Stewart is a member of the AAOS Opioid Task Force. Dr. Greis and several coauthors have disclosed no relevant financial relationships, and other coauthors report financial ties to companies unrelated to the research presented.
A version of this article first appeared on Medscape.com.
AT AAOS 2022
Going digital won’t fully fix prior authorizations, say medical groups
That was the message from groups representing physicians, medical practices, and hospitals in response to a request for input from the Office of the National Coordinator for Health Information Technology (ONC). In January, ONC requested public feedback on how making the process for insurer approvals digital can “ease the burden of prior authorization tasks on patients, providers, and payers.”
According to a study conducted by America’s Health Insurance Plans, 71% of providers who implemented electronic prior authorization experienced “faster time to patient care.” The organization, which represents many of the nation’s health insurers, also reported that electronic prior authorization reduced the time it took to receive a decision by a health plan by 69%.
In its response to ONC, the American Association of Family Physicians (AAFP) called out prior authorization as a “leading cause of physician burden” and wrote that the organization is “strongly supportive of efforts to reform and streamline the prior authorization process.”
AAFP, which represents 127,600 family physicians, residents, and students, cited in its comments an AMA survey in which 88% of physicians said that prior authorization “generates high or extremely high administrative burden” for their practices. Practices are responsible for an average of 41 prior authorizations per physician each week, which can take almost 2 days of a physician’s time each week, according to the AAFP.
Delayed care, increased confusion, reduced treatment adherence, and even discontinuation of treatment are some of the harms prior authorization causes patients, wrote AAFP board chair Ada D. Stewart, MD.
Electronic prior authorization is “just one step in addressing the flaws of utilization management practices, and comprehensive reform is needed to reduce the volume of prior authorizations and ensure patients’ timely access to care,” wrote Dr. Stewart.
AHA: Most common prior auth means are phones, fax
The American Hospital Association (AHA) highlighted the variety of prior authorization requests from different payers, writing, “While some plans accept electronic means, the most common method remains using fax machines and contacting call centers, with regular hold times of 20 to 30 minutes.”
The AHA’s Senior Vice President Ashley Thompson wrote that the various prior authorization processes required by payers take up staff time and increase the chance of data entry errors.
To fix this, the AHA calls for an “end-to-end automated prior authorization process that integrates with clinicians’ EHR workflow.” According to the AHA, this approach can help physicians have access to the required prior authorization information during treatment planning.
In response to the federal agency’s question about the functional capabilities for certified health IT modules to facilitate electronic prior authorization, the AAFP wrote that the standards should include communicating to providers the expected timeline from a payer on a response, the ability to access payers’ reasoning for denials, and the creation of a process for appealing decisions.
The ONC also asked for input on the use of three fast health care interoperability resources (FHIR)–based Da Vinci implementation guides in electronic prior authorization.
Developed by the Da Vinci Project in coordination with the HL7 Clinical Decision Support Workgroup, the FHIR-based implementation guides create a mechanism for reducing the burden on provider organizations and simplifying processes by establishing electronic versions of administrative and clinical requirements that are a part of providers’ workflow.
In its response, the AHA requested that prior authorization solutions “be fully developed and tested prior to wide scale industry rollout.”
The AAFP largely agreed with the AHA in its response, writing, “Only standards and [implementation guides] that have been proven effective and adoptable in real world testing should be candidates for mandatory certification and utilization, including the Da Vinci standards.”
The Medical Group Management Association (MGMA), which represents more than 60,000 medical practice administrators, executives, and leaders, supports the idea that electronic prior authorization “has the potential to decrease administrative burden through automation but only if implemented properly.”
In its comments, the MGMA called for broader reform of prior authorization. One way to accomplish that goal is by aligning electronic prior authorization standards “with payment and quality reporting programs, as well as care delivery models, to minimize burden and overhead costs.”
A version of this article first appeared on Medscape.com.
That was the message from groups representing physicians, medical practices, and hospitals in response to a request for input from the Office of the National Coordinator for Health Information Technology (ONC). In January, ONC requested public feedback on how making the process for insurer approvals digital can “ease the burden of prior authorization tasks on patients, providers, and payers.”
According to a study conducted by America’s Health Insurance Plans, 71% of providers who implemented electronic prior authorization experienced “faster time to patient care.” The organization, which represents many of the nation’s health insurers, also reported that electronic prior authorization reduced the time it took to receive a decision by a health plan by 69%.
In its response to ONC, the American Association of Family Physicians (AAFP) called out prior authorization as a “leading cause of physician burden” and wrote that the organization is “strongly supportive of efforts to reform and streamline the prior authorization process.”
AAFP, which represents 127,600 family physicians, residents, and students, cited in its comments an AMA survey in which 88% of physicians said that prior authorization “generates high or extremely high administrative burden” for their practices. Practices are responsible for an average of 41 prior authorizations per physician each week, which can take almost 2 days of a physician’s time each week, according to the AAFP.
Delayed care, increased confusion, reduced treatment adherence, and even discontinuation of treatment are some of the harms prior authorization causes patients, wrote AAFP board chair Ada D. Stewart, MD.
Electronic prior authorization is “just one step in addressing the flaws of utilization management practices, and comprehensive reform is needed to reduce the volume of prior authorizations and ensure patients’ timely access to care,” wrote Dr. Stewart.
AHA: Most common prior auth means are phones, fax
The American Hospital Association (AHA) highlighted the variety of prior authorization requests from different payers, writing, “While some plans accept electronic means, the most common method remains using fax machines and contacting call centers, with regular hold times of 20 to 30 minutes.”
The AHA’s Senior Vice President Ashley Thompson wrote that the various prior authorization processes required by payers take up staff time and increase the chance of data entry errors.
To fix this, the AHA calls for an “end-to-end automated prior authorization process that integrates with clinicians’ EHR workflow.” According to the AHA, this approach can help physicians have access to the required prior authorization information during treatment planning.
In response to the federal agency’s question about the functional capabilities for certified health IT modules to facilitate electronic prior authorization, the AAFP wrote that the standards should include communicating to providers the expected timeline from a payer on a response, the ability to access payers’ reasoning for denials, and the creation of a process for appealing decisions.
The ONC also asked for input on the use of three fast health care interoperability resources (FHIR)–based Da Vinci implementation guides in electronic prior authorization.
Developed by the Da Vinci Project in coordination with the HL7 Clinical Decision Support Workgroup, the FHIR-based implementation guides create a mechanism for reducing the burden on provider organizations and simplifying processes by establishing electronic versions of administrative and clinical requirements that are a part of providers’ workflow.
In its response, the AHA requested that prior authorization solutions “be fully developed and tested prior to wide scale industry rollout.”
The AAFP largely agreed with the AHA in its response, writing, “Only standards and [implementation guides] that have been proven effective and adoptable in real world testing should be candidates for mandatory certification and utilization, including the Da Vinci standards.”
The Medical Group Management Association (MGMA), which represents more than 60,000 medical practice administrators, executives, and leaders, supports the idea that electronic prior authorization “has the potential to decrease administrative burden through automation but only if implemented properly.”
In its comments, the MGMA called for broader reform of prior authorization. One way to accomplish that goal is by aligning electronic prior authorization standards “with payment and quality reporting programs, as well as care delivery models, to minimize burden and overhead costs.”
A version of this article first appeared on Medscape.com.
That was the message from groups representing physicians, medical practices, and hospitals in response to a request for input from the Office of the National Coordinator for Health Information Technology (ONC). In January, ONC requested public feedback on how making the process for insurer approvals digital can “ease the burden of prior authorization tasks on patients, providers, and payers.”
According to a study conducted by America’s Health Insurance Plans, 71% of providers who implemented electronic prior authorization experienced “faster time to patient care.” The organization, which represents many of the nation’s health insurers, also reported that electronic prior authorization reduced the time it took to receive a decision by a health plan by 69%.
In its response to ONC, the American Association of Family Physicians (AAFP) called out prior authorization as a “leading cause of physician burden” and wrote that the organization is “strongly supportive of efforts to reform and streamline the prior authorization process.”
AAFP, which represents 127,600 family physicians, residents, and students, cited in its comments an AMA survey in which 88% of physicians said that prior authorization “generates high or extremely high administrative burden” for their practices. Practices are responsible for an average of 41 prior authorizations per physician each week, which can take almost 2 days of a physician’s time each week, according to the AAFP.
Delayed care, increased confusion, reduced treatment adherence, and even discontinuation of treatment are some of the harms prior authorization causes patients, wrote AAFP board chair Ada D. Stewart, MD.
Electronic prior authorization is “just one step in addressing the flaws of utilization management practices, and comprehensive reform is needed to reduce the volume of prior authorizations and ensure patients’ timely access to care,” wrote Dr. Stewart.
AHA: Most common prior auth means are phones, fax
The American Hospital Association (AHA) highlighted the variety of prior authorization requests from different payers, writing, “While some plans accept electronic means, the most common method remains using fax machines and contacting call centers, with regular hold times of 20 to 30 minutes.”
The AHA’s Senior Vice President Ashley Thompson wrote that the various prior authorization processes required by payers take up staff time and increase the chance of data entry errors.
To fix this, the AHA calls for an “end-to-end automated prior authorization process that integrates with clinicians’ EHR workflow.” According to the AHA, this approach can help physicians have access to the required prior authorization information during treatment planning.
In response to the federal agency’s question about the functional capabilities for certified health IT modules to facilitate electronic prior authorization, the AAFP wrote that the standards should include communicating to providers the expected timeline from a payer on a response, the ability to access payers’ reasoning for denials, and the creation of a process for appealing decisions.
The ONC also asked for input on the use of three fast health care interoperability resources (FHIR)–based Da Vinci implementation guides in electronic prior authorization.
Developed by the Da Vinci Project in coordination with the HL7 Clinical Decision Support Workgroup, the FHIR-based implementation guides create a mechanism for reducing the burden on provider organizations and simplifying processes by establishing electronic versions of administrative and clinical requirements that are a part of providers’ workflow.
In its response, the AHA requested that prior authorization solutions “be fully developed and tested prior to wide scale industry rollout.”
The AAFP largely agreed with the AHA in its response, writing, “Only standards and [implementation guides] that have been proven effective and adoptable in real world testing should be candidates for mandatory certification and utilization, including the Da Vinci standards.”
The Medical Group Management Association (MGMA), which represents more than 60,000 medical practice administrators, executives, and leaders, supports the idea that electronic prior authorization “has the potential to decrease administrative burden through automation but only if implemented properly.”
In its comments, the MGMA called for broader reform of prior authorization. One way to accomplish that goal is by aligning electronic prior authorization standards “with payment and quality reporting programs, as well as care delivery models, to minimize burden and overhead costs.”
A version of this article first appeared on Medscape.com.
Clinical Edge Journal Scan Commentary: PsA April 2022
Treatment of psoriatic arthritis (PsA) was the focus of clinical research papers published this month. Despite the advances made in treating PsA with targeted therapies, in most parts of the world, conventional disease-modifying antirheumatic drugs (DMARDs) are the first line of treatment. Methotrexate (MTX) and leflunomide (LEF) are commonly used, but there are limited data on the effectiveness of combination therapy. To address this issue, Mulder and colleagues enrolled 78 patients with active PsA who have two or more swollen joints and randomly allocated them to either 25 mg oral MTX weekly after 4 weeks of 15 mg weekly plus 20 mg LEF daily (n = 39) or MTX plus placebo (monotherapy; n = 39). At week 16, PsA disease activity score was improved significantly in the MTX + LEF vs. MTX monotherapy group (3.1 vs. 3.7; P = .025). Incidence of mild adverse events, such as nausea/vomiting (44% vs. 28%) and altered bowel habits (26% vs. 8%), was higher with MTX + LEF vs. MTX + placebo. So although less well tolerated, MTX + LEF therapy was superior to MTX monotherapy at improving disease activity in patients with PsA.
Biologics targeting tumor necrosis factor (TNF), interleukin (IL) -12/23, -23, and -17A are efficacious for the management of PsA, but questions remain about comparative effectiveness. Gossec and colleagues reported the results from their prospective observational PsABio study that evaluated real-world treatment persistence and effectiveness at 1 year after initiation of first-line to third-line IL-12/23 inhibitor ustekinumab or a TNF inhibitor (TNFi). Their study followed 893 patients. After 1 year of treatment, ustekinumab and the TNFi showed similar persistence (hazard ratio [HR] for stopping/switching treatment 0.82; 95% CI 0.60-1.13) and a similar proportion of patients achieving (on the Disease Activity Index for PsA) clinical low disease activity (odds ratio [OR] 0.80; 95% CI 0.57-1.10) and remission (OR 0.73; 95% CI 0.49-1.07), along with similar safety profiles. Thus in real-world studies, TNFi and ustekinumab seem to have similar effectiveness and safety.
Drug persistence between patients with psoriasis alone vs. those with PsA is also of interest. In a real-life study including 62 patients with psoriasis and 90 patients with PsA who initiated treatment with secukinumab and were followed up for 24 months or until discontinuation, Ortolan and colleagues demonstrated that the retention rate of secukinumab was higher in psoriasis vs. PsA at 12 (85% vs. 68%) and 24 (61% vs. 57%) months, with the risk for secukinumab discontinuation being higher among patients with PsA in the overall cohort (HR 2.43; P = .035) and in patients with obesity in the PsA cohort (P = .021). Thus, the presence of PsA and obesity lower the secukinumab retention rate.
- Despite the advent of many targeted therapies for PsA, there remain many unmet needs. Deucravacitinib is a novel oral selective inhibitor of tyrosine kinase 2 (TYK2) acting via binding to the TYK2 regulatory domain. In a phase 2 study including 203 patients with active PsA that was intolerant to at least one therapy who were randomly assigned to receive 6 mg deucravacitinib once daily, 12 mg deucravacitinib once daily, or placebo for 16 weeks, Mease and colleagues demonstrated that at week 16, American College of Rheumatology 20 (ACR20) response was significantly higher with 6 mg once-daily deucravacitinib (52.9%, adjusted OR [aOR] 2.4; P = .0134) and 12 mg (62.7%, aOR 3.6; P = .0004) vs. placebo (31.8%), with 12 mg deucravacitinib improving ACR20 response as early as at 8 weeks (P < .05). No serious adverse events were reported. Thus, TYK2 inhibition shows promise in the treatment of PsA and the results from phase 3 trials are awaited.
Treatment of psoriatic arthritis (PsA) was the focus of clinical research papers published this month. Despite the advances made in treating PsA with targeted therapies, in most parts of the world, conventional disease-modifying antirheumatic drugs (DMARDs) are the first line of treatment. Methotrexate (MTX) and leflunomide (LEF) are commonly used, but there are limited data on the effectiveness of combination therapy. To address this issue, Mulder and colleagues enrolled 78 patients with active PsA who have two or more swollen joints and randomly allocated them to either 25 mg oral MTX weekly after 4 weeks of 15 mg weekly plus 20 mg LEF daily (n = 39) or MTX plus placebo (monotherapy; n = 39). At week 16, PsA disease activity score was improved significantly in the MTX + LEF vs. MTX monotherapy group (3.1 vs. 3.7; P = .025). Incidence of mild adverse events, such as nausea/vomiting (44% vs. 28%) and altered bowel habits (26% vs. 8%), was higher with MTX + LEF vs. MTX + placebo. So although less well tolerated, MTX + LEF therapy was superior to MTX monotherapy at improving disease activity in patients with PsA.
Biologics targeting tumor necrosis factor (TNF), interleukin (IL) -12/23, -23, and -17A are efficacious for the management of PsA, but questions remain about comparative effectiveness. Gossec and colleagues reported the results from their prospective observational PsABio study that evaluated real-world treatment persistence and effectiveness at 1 year after initiation of first-line to third-line IL-12/23 inhibitor ustekinumab or a TNF inhibitor (TNFi). Their study followed 893 patients. After 1 year of treatment, ustekinumab and the TNFi showed similar persistence (hazard ratio [HR] for stopping/switching treatment 0.82; 95% CI 0.60-1.13) and a similar proportion of patients achieving (on the Disease Activity Index for PsA) clinical low disease activity (odds ratio [OR] 0.80; 95% CI 0.57-1.10) and remission (OR 0.73; 95% CI 0.49-1.07), along with similar safety profiles. Thus in real-world studies, TNFi and ustekinumab seem to have similar effectiveness and safety.
Drug persistence between patients with psoriasis alone vs. those with PsA is also of interest. In a real-life study including 62 patients with psoriasis and 90 patients with PsA who initiated treatment with secukinumab and were followed up for 24 months or until discontinuation, Ortolan and colleagues demonstrated that the retention rate of secukinumab was higher in psoriasis vs. PsA at 12 (85% vs. 68%) and 24 (61% vs. 57%) months, with the risk for secukinumab discontinuation being higher among patients with PsA in the overall cohort (HR 2.43; P = .035) and in patients with obesity in the PsA cohort (P = .021). Thus, the presence of PsA and obesity lower the secukinumab retention rate.
- Despite the advent of many targeted therapies for PsA, there remain many unmet needs. Deucravacitinib is a novel oral selective inhibitor of tyrosine kinase 2 (TYK2) acting via binding to the TYK2 regulatory domain. In a phase 2 study including 203 patients with active PsA that was intolerant to at least one therapy who were randomly assigned to receive 6 mg deucravacitinib once daily, 12 mg deucravacitinib once daily, or placebo for 16 weeks, Mease and colleagues demonstrated that at week 16, American College of Rheumatology 20 (ACR20) response was significantly higher with 6 mg once-daily deucravacitinib (52.9%, adjusted OR [aOR] 2.4; P = .0134) and 12 mg (62.7%, aOR 3.6; P = .0004) vs. placebo (31.8%), with 12 mg deucravacitinib improving ACR20 response as early as at 8 weeks (P < .05). No serious adverse events were reported. Thus, TYK2 inhibition shows promise in the treatment of PsA and the results from phase 3 trials are awaited.
Treatment of psoriatic arthritis (PsA) was the focus of clinical research papers published this month. Despite the advances made in treating PsA with targeted therapies, in most parts of the world, conventional disease-modifying antirheumatic drugs (DMARDs) are the first line of treatment. Methotrexate (MTX) and leflunomide (LEF) are commonly used, but there are limited data on the effectiveness of combination therapy. To address this issue, Mulder and colleagues enrolled 78 patients with active PsA who have two or more swollen joints and randomly allocated them to either 25 mg oral MTX weekly after 4 weeks of 15 mg weekly plus 20 mg LEF daily (n = 39) or MTX plus placebo (monotherapy; n = 39). At week 16, PsA disease activity score was improved significantly in the MTX + LEF vs. MTX monotherapy group (3.1 vs. 3.7; P = .025). Incidence of mild adverse events, such as nausea/vomiting (44% vs. 28%) and altered bowel habits (26% vs. 8%), was higher with MTX + LEF vs. MTX + placebo. So although less well tolerated, MTX + LEF therapy was superior to MTX monotherapy at improving disease activity in patients with PsA.
Biologics targeting tumor necrosis factor (TNF), interleukin (IL) -12/23, -23, and -17A are efficacious for the management of PsA, but questions remain about comparative effectiveness. Gossec and colleagues reported the results from their prospective observational PsABio study that evaluated real-world treatment persistence and effectiveness at 1 year after initiation of first-line to third-line IL-12/23 inhibitor ustekinumab or a TNF inhibitor (TNFi). Their study followed 893 patients. After 1 year of treatment, ustekinumab and the TNFi showed similar persistence (hazard ratio [HR] for stopping/switching treatment 0.82; 95% CI 0.60-1.13) and a similar proportion of patients achieving (on the Disease Activity Index for PsA) clinical low disease activity (odds ratio [OR] 0.80; 95% CI 0.57-1.10) and remission (OR 0.73; 95% CI 0.49-1.07), along with similar safety profiles. Thus in real-world studies, TNFi and ustekinumab seem to have similar effectiveness and safety.
Drug persistence between patients with psoriasis alone vs. those with PsA is also of interest. In a real-life study including 62 patients with psoriasis and 90 patients with PsA who initiated treatment with secukinumab and were followed up for 24 months or until discontinuation, Ortolan and colleagues demonstrated that the retention rate of secukinumab was higher in psoriasis vs. PsA at 12 (85% vs. 68%) and 24 (61% vs. 57%) months, with the risk for secukinumab discontinuation being higher among patients with PsA in the overall cohort (HR 2.43; P = .035) and in patients with obesity in the PsA cohort (P = .021). Thus, the presence of PsA and obesity lower the secukinumab retention rate.
- Despite the advent of many targeted therapies for PsA, there remain many unmet needs. Deucravacitinib is a novel oral selective inhibitor of tyrosine kinase 2 (TYK2) acting via binding to the TYK2 regulatory domain. In a phase 2 study including 203 patients with active PsA that was intolerant to at least one therapy who were randomly assigned to receive 6 mg deucravacitinib once daily, 12 mg deucravacitinib once daily, or placebo for 16 weeks, Mease and colleagues demonstrated that at week 16, American College of Rheumatology 20 (ACR20) response was significantly higher with 6 mg once-daily deucravacitinib (52.9%, adjusted OR [aOR] 2.4; P = .0134) and 12 mg (62.7%, aOR 3.6; P = .0004) vs. placebo (31.8%), with 12 mg deucravacitinib improving ACR20 response as early as at 8 weeks (P < .05). No serious adverse events were reported. Thus, TYK2 inhibition shows promise in the treatment of PsA and the results from phase 3 trials are awaited.