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COVID bivalent booster better vs. recent Omicron subvariants: Pfizer
the company reported on Nov. 4, supporting calls by public health officials for eligible people to get this booster before a potential COVID-19 surge this winter.
The company’s ongoing phase 2/3 study of their Omicron BA.4 and BA.5 bivalent – which targets both the virus’ original strain and the two subvariants – shows that the vaccine offered the strongest protection in people older than 55 years.
One month after receiving a 30-mcg booster with the bivalent vaccine, those older than 55 had four times more neutralizing antibodies against these Omicron subvariants, compared with people who received the original monovalent vaccine as a booster in the study.
Researchers compared the geometric mean titer (GMT) levels of these antibodies in three groups before and 1 month after boosting. The 36 people older than 55 years in the released study findings had an GMT level of 896 with the bivalent booster, a level 13 times higher than before this immunization.
For the 38 adults ages 18-55 in the study, the GMT level increased to 606 at 1 month after the bivalent booster, an increase of almost 10-fold, compared with baseline. In a comparator group of 40 people receiving the original vaccine as a fourth dose, the GMT level was 236, or threefold higher than before their booster shot.
The newly released data is “very encouraging and consistent now with three studies all showing a substantial 3-4 fold increased level of neutralizing antibodies versus BA.5 as compared with the original booster,” said Eric Topol, MD, director of the Scripps Research Translational Institute in La Jolla, Calif., and editor-in-chief of Medscape Medical News.
Pfizer and BioNTech announced the updated findings in a Nov. 4 press release.
A booster dose of the BA.4/BA.5-adapted bivalent vaccine is authorized for emergency use by the Food and Drug Administration for ages 5 years and older. The safety and tolerability profile of the Pfizer/BioNTech bivalent booster remains favorable and similar to the original COVID-19 vaccine, the company reported.
Until recently, the BA.5 Omicron variant was the dominant strain in the United States, but is now getting elbowed out by the subvariants BQ.1.1, BQ.1, and BA.4.6, which together make up almost 45% of the circulating virus.
Some skepticism
“It is important to note that these data are press-release level, which does not allow a view of the data totality,” Hana El Sahly, MD, professor of molecular virology and microbiology, Baylor College of Medicine, Houston, said in an interview.
“For example, there may be significant differences between the groups, and the release mentions at least one difference that is of importance: the interval since the last vaccination which often affects the response to subsequent boosting,” she said.
Dr. El Sahly added that the findings are not surprising. “In the short term, a variant-specific vaccine produces a higher level of antibody against the variant in the vaccine than the vaccines based on the ancestral strains.”
More researcher results are warranted. “These data do not indicate that these differences between the two vaccines translate into a meaningful clinical benefit at a population level,” Dr. El Sahly said.
An uncertain winter ahead
“As we head into the holiday season, we hope these updated data will encourage people to seek out a COVID-19 bivalent booster as soon as they are eligible in order to maintain high levels of protection against the widely circulating Omicron BA.4 and BA.5 sublineages,” Albert Bourla, Pfizer chairman and CEO, stated in the release.
The updated data from the Pfizer/BioNTech study are “all the more reason to get a booster, with added protection also versus BQ.1.1, which will soon become dominant in the U.S.,” Dr. Topol predicted.
It is unclear when the next surge will happen, as COVID-19 does not always follow a seasonal pattern, at least not yet, Dr. El Sahly said. “Regardless, it is reasonable to recommend additional vaccine doses to immunocompromised and frail or older persons. More importantly, influenza vaccination and being up to date on pneumococcal vaccines are highly recommended as soon as feasible, given the early and intense flu season.”
A version of this article first appeared on Medscape.com.
the company reported on Nov. 4, supporting calls by public health officials for eligible people to get this booster before a potential COVID-19 surge this winter.
The company’s ongoing phase 2/3 study of their Omicron BA.4 and BA.5 bivalent – which targets both the virus’ original strain and the two subvariants – shows that the vaccine offered the strongest protection in people older than 55 years.
One month after receiving a 30-mcg booster with the bivalent vaccine, those older than 55 had four times more neutralizing antibodies against these Omicron subvariants, compared with people who received the original monovalent vaccine as a booster in the study.
Researchers compared the geometric mean titer (GMT) levels of these antibodies in three groups before and 1 month after boosting. The 36 people older than 55 years in the released study findings had an GMT level of 896 with the bivalent booster, a level 13 times higher than before this immunization.
For the 38 adults ages 18-55 in the study, the GMT level increased to 606 at 1 month after the bivalent booster, an increase of almost 10-fold, compared with baseline. In a comparator group of 40 people receiving the original vaccine as a fourth dose, the GMT level was 236, or threefold higher than before their booster shot.
The newly released data is “very encouraging and consistent now with three studies all showing a substantial 3-4 fold increased level of neutralizing antibodies versus BA.5 as compared with the original booster,” said Eric Topol, MD, director of the Scripps Research Translational Institute in La Jolla, Calif., and editor-in-chief of Medscape Medical News.
Pfizer and BioNTech announced the updated findings in a Nov. 4 press release.
A booster dose of the BA.4/BA.5-adapted bivalent vaccine is authorized for emergency use by the Food and Drug Administration for ages 5 years and older. The safety and tolerability profile of the Pfizer/BioNTech bivalent booster remains favorable and similar to the original COVID-19 vaccine, the company reported.
Until recently, the BA.5 Omicron variant was the dominant strain in the United States, but is now getting elbowed out by the subvariants BQ.1.1, BQ.1, and BA.4.6, which together make up almost 45% of the circulating virus.
Some skepticism
“It is important to note that these data are press-release level, which does not allow a view of the data totality,” Hana El Sahly, MD, professor of molecular virology and microbiology, Baylor College of Medicine, Houston, said in an interview.
“For example, there may be significant differences between the groups, and the release mentions at least one difference that is of importance: the interval since the last vaccination which often affects the response to subsequent boosting,” she said.
Dr. El Sahly added that the findings are not surprising. “In the short term, a variant-specific vaccine produces a higher level of antibody against the variant in the vaccine than the vaccines based on the ancestral strains.”
More researcher results are warranted. “These data do not indicate that these differences between the two vaccines translate into a meaningful clinical benefit at a population level,” Dr. El Sahly said.
An uncertain winter ahead
“As we head into the holiday season, we hope these updated data will encourage people to seek out a COVID-19 bivalent booster as soon as they are eligible in order to maintain high levels of protection against the widely circulating Omicron BA.4 and BA.5 sublineages,” Albert Bourla, Pfizer chairman and CEO, stated in the release.
The updated data from the Pfizer/BioNTech study are “all the more reason to get a booster, with added protection also versus BQ.1.1, which will soon become dominant in the U.S.,” Dr. Topol predicted.
It is unclear when the next surge will happen, as COVID-19 does not always follow a seasonal pattern, at least not yet, Dr. El Sahly said. “Regardless, it is reasonable to recommend additional vaccine doses to immunocompromised and frail or older persons. More importantly, influenza vaccination and being up to date on pneumococcal vaccines are highly recommended as soon as feasible, given the early and intense flu season.”
A version of this article first appeared on Medscape.com.
the company reported on Nov. 4, supporting calls by public health officials for eligible people to get this booster before a potential COVID-19 surge this winter.
The company’s ongoing phase 2/3 study of their Omicron BA.4 and BA.5 bivalent – which targets both the virus’ original strain and the two subvariants – shows that the vaccine offered the strongest protection in people older than 55 years.
One month after receiving a 30-mcg booster with the bivalent vaccine, those older than 55 had four times more neutralizing antibodies against these Omicron subvariants, compared with people who received the original monovalent vaccine as a booster in the study.
Researchers compared the geometric mean titer (GMT) levels of these antibodies in three groups before and 1 month after boosting. The 36 people older than 55 years in the released study findings had an GMT level of 896 with the bivalent booster, a level 13 times higher than before this immunization.
For the 38 adults ages 18-55 in the study, the GMT level increased to 606 at 1 month after the bivalent booster, an increase of almost 10-fold, compared with baseline. In a comparator group of 40 people receiving the original vaccine as a fourth dose, the GMT level was 236, or threefold higher than before their booster shot.
The newly released data is “very encouraging and consistent now with three studies all showing a substantial 3-4 fold increased level of neutralizing antibodies versus BA.5 as compared with the original booster,” said Eric Topol, MD, director of the Scripps Research Translational Institute in La Jolla, Calif., and editor-in-chief of Medscape Medical News.
Pfizer and BioNTech announced the updated findings in a Nov. 4 press release.
A booster dose of the BA.4/BA.5-adapted bivalent vaccine is authorized for emergency use by the Food and Drug Administration for ages 5 years and older. The safety and tolerability profile of the Pfizer/BioNTech bivalent booster remains favorable and similar to the original COVID-19 vaccine, the company reported.
Until recently, the BA.5 Omicron variant was the dominant strain in the United States, but is now getting elbowed out by the subvariants BQ.1.1, BQ.1, and BA.4.6, which together make up almost 45% of the circulating virus.
Some skepticism
“It is important to note that these data are press-release level, which does not allow a view of the data totality,” Hana El Sahly, MD, professor of molecular virology and microbiology, Baylor College of Medicine, Houston, said in an interview.
“For example, there may be significant differences between the groups, and the release mentions at least one difference that is of importance: the interval since the last vaccination which often affects the response to subsequent boosting,” she said.
Dr. El Sahly added that the findings are not surprising. “In the short term, a variant-specific vaccine produces a higher level of antibody against the variant in the vaccine than the vaccines based on the ancestral strains.”
More researcher results are warranted. “These data do not indicate that these differences between the two vaccines translate into a meaningful clinical benefit at a population level,” Dr. El Sahly said.
An uncertain winter ahead
“As we head into the holiday season, we hope these updated data will encourage people to seek out a COVID-19 bivalent booster as soon as they are eligible in order to maintain high levels of protection against the widely circulating Omicron BA.4 and BA.5 sublineages,” Albert Bourla, Pfizer chairman and CEO, stated in the release.
The updated data from the Pfizer/BioNTech study are “all the more reason to get a booster, with added protection also versus BQ.1.1, which will soon become dominant in the U.S.,” Dr. Topol predicted.
It is unclear when the next surge will happen, as COVID-19 does not always follow a seasonal pattern, at least not yet, Dr. El Sahly said. “Regardless, it is reasonable to recommend additional vaccine doses to immunocompromised and frail or older persons. More importantly, influenza vaccination and being up to date on pneumococcal vaccines are highly recommended as soon as feasible, given the early and intense flu season.”
A version of this article first appeared on Medscape.com.
RBX2660 shows promise in breaking the cycle of recurrent C. difficile
CHARLOTTE, N.C. –
Following a standard course of antibiotics, a one-time treatment with RBX2660 was successful for three quarters of participants at 8 weeks, according to a new study. It also prevented additional bouts, with 84% of these initial responders remaining free of C. difficile infection at 6 months.
The ongoing phase 3, open-label PUNCH CD3-OLS study expands on clinical trial experience by treating more “real-world” patients. People who might have been excluded from previous research because of comorbidities, such as irritable bowel syndrome, inflammatory bowel disease, and immunosuppression, were included.
The study also placed no limit on the number of previous rounds of C. difficile infections.
“Even when you expand the patient population to make it more generalizable, we’re still seeing both a high cure rate and a high success rate,” Sahil Khanna, MBBS, a gastroenterologist and hepatologist at the Mayo Clinic in Rochester, Minn., said in an interview.
“We also are not seeing any kind of safety signals that can be attributed to this particular product,” he said.
Dr. Khanna presented the findings during the annual meeting of the American College of Gastroenterology, which were also published simultaneously in the journal Drugs. The research by Dr. Khanna and associates received an ACG Outstanding Research Award in the colon category.
Study design and results
RBX2660 (Rebyota) is a microbiota-based live biotherapeutic in development from Ferring Pharmaceuticals. The treatment contains human stool collected from prescreened, qualified donors and is prepared according to good manufacturing standards.
After standard-of-care antibiotics and a 72-hour washout period, participants received a single 150-mL dose rectally by enema. RBX2660 is administered by a health care professional.
The median age of study participants was 63 years, with 45% aged 65 years or older, and 70% were women. Overall, 37% of participants had Crohn’s disease and 4% had ulcerative colitis.
At the time of screening, about half of participants had a history of one or two infections with C. difficile, and the remaining half reported three or more episodes.
Of the 402 participants whose outcomes could be analyzed, 75% reported treatment success, meaning no further C. difficile infections at 8 weeks. This was consistent with the 75% of 60 participants free of C. difficile in the interim analysis reported in 2021. Efficacy results were based on a modified intent-to-treat analysis.
Of the 300 participants who responded to RBX2660 at 8 weeks, 262 were followed up to 6 months, with 84% of these reporting no C. difficile recurrence.
“If you succeeded to 8 weeks, there was a high likelihood that you would succeed up to 6 months,” Dr. Khanna said.
For the subset of participants with inflammatory bowel disease, Dr. Khanna noted that the success rates were in the 80% range, which is higher than what is seen in clinic fecal microbiota transplantation programs.
Adverse events
Of the participants, 63% reported treatment-emergent adverse events. Most events were mild to moderate in severity, the researchers reported, with diarrhea and abdominal pain being the most common.
“When you look at the treatment-emergent adverse events, it’s important to put them into context in terms of this patient population,” Dr. Khanna said. “This recurrent population has developed underlying gastrointestinal symptoms like abdominal pain, diarrhea, nausea, vomiting, and weight loss.”
Some of these adverse events persist beyond resolution of the C. difficile infection, and the adverse-event profile with RBX2660 is consistent with what is seen following fecal microbiota transplantation, he added.
The serious adverse events “were very, very few,” Dr. Khanna said.
Overall, 11% of participants reported a serious adverse event. The majority were related to the C. difficile infection or an underlying comorbidity, he noted.
“Excruciating for patients to deal with”
Traditionally, there could be “some hesitation on the patient’s part [to undergo therapy] just because it’s delivered rectally,” session comoderator Lisa Malter, MD, said in an interview.
However, C. difficile can be “excruciating for patients to deal with,” said Dr. Malter, a gastroenterologist and professor of medicine at New York University Langone Health. They “may be more than willing to take [this agent] because it gets them feeling better.”
“This is a positive adjunct to our current therapies for C. diff in terms of trying to knock it out once a standard course of antibiotics has been administered,” she added.
Currently, people with recurrent C. difficile seek fecal microbiota material from a biobank or from a close friend or loved one.
But Dr. Malter noted that asking someone you know to donate fecal matter for transplantation requires several steps. Donors are screened to make sure they are free of gastrointestinal illness, are not taking any contraindicated medications, and do not have active infection.
Fecal microbiota samples from a biobank are more standardized, but there have been intermittent shutdowns and availability has been limited during the pandemic, she said.
Dr. Malter added that one unanswered question is how much of the colon is covered by therapy delivery via enema compared with colonoscope delivery during fecal microbiota transplantation.
“If it’s delivered colonoscopically, you get the entire colon. In contrast with an enema, you really only hit the left side of the colon,” she said.
FDA advisory committee nod
On Sept. 26, the Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee reviewed evidence for RBX2660. The committee voted 13 to 4 that data were adequate to support the effectiveness of RBX2660 to reduce the recurrence of C. difficile infection in adults following antibiotic treatment for recurrent infections.
Members also voted 12 to 4, with one abstention, that the data were adequate to support the product’s safety.
The FDA often follows its advisory committee recommendations but is not required to do so.
“The hope would be that this would get through the usual FDA pipeline of an approval in the near future,” Dr. Khanna said.
The study was funded by Ferring Pharmaceuticals. Dr. Khanna reported receiving grant and research funding from Ferring. Dr. Malter reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
CHARLOTTE, N.C. –
Following a standard course of antibiotics, a one-time treatment with RBX2660 was successful for three quarters of participants at 8 weeks, according to a new study. It also prevented additional bouts, with 84% of these initial responders remaining free of C. difficile infection at 6 months.
The ongoing phase 3, open-label PUNCH CD3-OLS study expands on clinical trial experience by treating more “real-world” patients. People who might have been excluded from previous research because of comorbidities, such as irritable bowel syndrome, inflammatory bowel disease, and immunosuppression, were included.
The study also placed no limit on the number of previous rounds of C. difficile infections.
“Even when you expand the patient population to make it more generalizable, we’re still seeing both a high cure rate and a high success rate,” Sahil Khanna, MBBS, a gastroenterologist and hepatologist at the Mayo Clinic in Rochester, Minn., said in an interview.
“We also are not seeing any kind of safety signals that can be attributed to this particular product,” he said.
Dr. Khanna presented the findings during the annual meeting of the American College of Gastroenterology, which were also published simultaneously in the journal Drugs. The research by Dr. Khanna and associates received an ACG Outstanding Research Award in the colon category.
Study design and results
RBX2660 (Rebyota) is a microbiota-based live biotherapeutic in development from Ferring Pharmaceuticals. The treatment contains human stool collected from prescreened, qualified donors and is prepared according to good manufacturing standards.
After standard-of-care antibiotics and a 72-hour washout period, participants received a single 150-mL dose rectally by enema. RBX2660 is administered by a health care professional.
The median age of study participants was 63 years, with 45% aged 65 years or older, and 70% were women. Overall, 37% of participants had Crohn’s disease and 4% had ulcerative colitis.
At the time of screening, about half of participants had a history of one or two infections with C. difficile, and the remaining half reported three or more episodes.
Of the 402 participants whose outcomes could be analyzed, 75% reported treatment success, meaning no further C. difficile infections at 8 weeks. This was consistent with the 75% of 60 participants free of C. difficile in the interim analysis reported in 2021. Efficacy results were based on a modified intent-to-treat analysis.
Of the 300 participants who responded to RBX2660 at 8 weeks, 262 were followed up to 6 months, with 84% of these reporting no C. difficile recurrence.
“If you succeeded to 8 weeks, there was a high likelihood that you would succeed up to 6 months,” Dr. Khanna said.
For the subset of participants with inflammatory bowel disease, Dr. Khanna noted that the success rates were in the 80% range, which is higher than what is seen in clinic fecal microbiota transplantation programs.
Adverse events
Of the participants, 63% reported treatment-emergent adverse events. Most events were mild to moderate in severity, the researchers reported, with diarrhea and abdominal pain being the most common.
“When you look at the treatment-emergent adverse events, it’s important to put them into context in terms of this patient population,” Dr. Khanna said. “This recurrent population has developed underlying gastrointestinal symptoms like abdominal pain, diarrhea, nausea, vomiting, and weight loss.”
Some of these adverse events persist beyond resolution of the C. difficile infection, and the adverse-event profile with RBX2660 is consistent with what is seen following fecal microbiota transplantation, he added.
The serious adverse events “were very, very few,” Dr. Khanna said.
Overall, 11% of participants reported a serious adverse event. The majority were related to the C. difficile infection or an underlying comorbidity, he noted.
“Excruciating for patients to deal with”
Traditionally, there could be “some hesitation on the patient’s part [to undergo therapy] just because it’s delivered rectally,” session comoderator Lisa Malter, MD, said in an interview.
However, C. difficile can be “excruciating for patients to deal with,” said Dr. Malter, a gastroenterologist and professor of medicine at New York University Langone Health. They “may be more than willing to take [this agent] because it gets them feeling better.”
“This is a positive adjunct to our current therapies for C. diff in terms of trying to knock it out once a standard course of antibiotics has been administered,” she added.
Currently, people with recurrent C. difficile seek fecal microbiota material from a biobank or from a close friend or loved one.
But Dr. Malter noted that asking someone you know to donate fecal matter for transplantation requires several steps. Donors are screened to make sure they are free of gastrointestinal illness, are not taking any contraindicated medications, and do not have active infection.
Fecal microbiota samples from a biobank are more standardized, but there have been intermittent shutdowns and availability has been limited during the pandemic, she said.
Dr. Malter added that one unanswered question is how much of the colon is covered by therapy delivery via enema compared with colonoscope delivery during fecal microbiota transplantation.
“If it’s delivered colonoscopically, you get the entire colon. In contrast with an enema, you really only hit the left side of the colon,” she said.
FDA advisory committee nod
On Sept. 26, the Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee reviewed evidence for RBX2660. The committee voted 13 to 4 that data were adequate to support the effectiveness of RBX2660 to reduce the recurrence of C. difficile infection in adults following antibiotic treatment for recurrent infections.
Members also voted 12 to 4, with one abstention, that the data were adequate to support the product’s safety.
The FDA often follows its advisory committee recommendations but is not required to do so.
“The hope would be that this would get through the usual FDA pipeline of an approval in the near future,” Dr. Khanna said.
The study was funded by Ferring Pharmaceuticals. Dr. Khanna reported receiving grant and research funding from Ferring. Dr. Malter reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
CHARLOTTE, N.C. –
Following a standard course of antibiotics, a one-time treatment with RBX2660 was successful for three quarters of participants at 8 weeks, according to a new study. It also prevented additional bouts, with 84% of these initial responders remaining free of C. difficile infection at 6 months.
The ongoing phase 3, open-label PUNCH CD3-OLS study expands on clinical trial experience by treating more “real-world” patients. People who might have been excluded from previous research because of comorbidities, such as irritable bowel syndrome, inflammatory bowel disease, and immunosuppression, were included.
The study also placed no limit on the number of previous rounds of C. difficile infections.
“Even when you expand the patient population to make it more generalizable, we’re still seeing both a high cure rate and a high success rate,” Sahil Khanna, MBBS, a gastroenterologist and hepatologist at the Mayo Clinic in Rochester, Minn., said in an interview.
“We also are not seeing any kind of safety signals that can be attributed to this particular product,” he said.
Dr. Khanna presented the findings during the annual meeting of the American College of Gastroenterology, which were also published simultaneously in the journal Drugs. The research by Dr. Khanna and associates received an ACG Outstanding Research Award in the colon category.
Study design and results
RBX2660 (Rebyota) is a microbiota-based live biotherapeutic in development from Ferring Pharmaceuticals. The treatment contains human stool collected from prescreened, qualified donors and is prepared according to good manufacturing standards.
After standard-of-care antibiotics and a 72-hour washout period, participants received a single 150-mL dose rectally by enema. RBX2660 is administered by a health care professional.
The median age of study participants was 63 years, with 45% aged 65 years or older, and 70% were women. Overall, 37% of participants had Crohn’s disease and 4% had ulcerative colitis.
At the time of screening, about half of participants had a history of one or two infections with C. difficile, and the remaining half reported three or more episodes.
Of the 402 participants whose outcomes could be analyzed, 75% reported treatment success, meaning no further C. difficile infections at 8 weeks. This was consistent with the 75% of 60 participants free of C. difficile in the interim analysis reported in 2021. Efficacy results were based on a modified intent-to-treat analysis.
Of the 300 participants who responded to RBX2660 at 8 weeks, 262 were followed up to 6 months, with 84% of these reporting no C. difficile recurrence.
“If you succeeded to 8 weeks, there was a high likelihood that you would succeed up to 6 months,” Dr. Khanna said.
For the subset of participants with inflammatory bowel disease, Dr. Khanna noted that the success rates were in the 80% range, which is higher than what is seen in clinic fecal microbiota transplantation programs.
Adverse events
Of the participants, 63% reported treatment-emergent adverse events. Most events were mild to moderate in severity, the researchers reported, with diarrhea and abdominal pain being the most common.
“When you look at the treatment-emergent adverse events, it’s important to put them into context in terms of this patient population,” Dr. Khanna said. “This recurrent population has developed underlying gastrointestinal symptoms like abdominal pain, diarrhea, nausea, vomiting, and weight loss.”
Some of these adverse events persist beyond resolution of the C. difficile infection, and the adverse-event profile with RBX2660 is consistent with what is seen following fecal microbiota transplantation, he added.
The serious adverse events “were very, very few,” Dr. Khanna said.
Overall, 11% of participants reported a serious adverse event. The majority were related to the C. difficile infection or an underlying comorbidity, he noted.
“Excruciating for patients to deal with”
Traditionally, there could be “some hesitation on the patient’s part [to undergo therapy] just because it’s delivered rectally,” session comoderator Lisa Malter, MD, said in an interview.
However, C. difficile can be “excruciating for patients to deal with,” said Dr. Malter, a gastroenterologist and professor of medicine at New York University Langone Health. They “may be more than willing to take [this agent] because it gets them feeling better.”
“This is a positive adjunct to our current therapies for C. diff in terms of trying to knock it out once a standard course of antibiotics has been administered,” she added.
Currently, people with recurrent C. difficile seek fecal microbiota material from a biobank or from a close friend or loved one.
But Dr. Malter noted that asking someone you know to donate fecal matter for transplantation requires several steps. Donors are screened to make sure they are free of gastrointestinal illness, are not taking any contraindicated medications, and do not have active infection.
Fecal microbiota samples from a biobank are more standardized, but there have been intermittent shutdowns and availability has been limited during the pandemic, she said.
Dr. Malter added that one unanswered question is how much of the colon is covered by therapy delivery via enema compared with colonoscope delivery during fecal microbiota transplantation.
“If it’s delivered colonoscopically, you get the entire colon. In contrast with an enema, you really only hit the left side of the colon,” she said.
FDA advisory committee nod
On Sept. 26, the Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee reviewed evidence for RBX2660. The committee voted 13 to 4 that data were adequate to support the effectiveness of RBX2660 to reduce the recurrence of C. difficile infection in adults following antibiotic treatment for recurrent infections.
Members also voted 12 to 4, with one abstention, that the data were adequate to support the product’s safety.
The FDA often follows its advisory committee recommendations but is not required to do so.
“The hope would be that this would get through the usual FDA pipeline of an approval in the near future,” Dr. Khanna said.
The study was funded by Ferring Pharmaceuticals. Dr. Khanna reported receiving grant and research funding from Ferring. Dr. Malter reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
AT ACG 2022
Risk factors ID’d for acute pancreatitis from weight-loss drugs
CHARLOTTE, N.C. – a new study has found.
Type 2 diabetes, advanced chronic kidney disease, and tobacco use were associated with greater risk for acute pancreatitis, researchers report.
On the other hand, a higher body mass index (BMI) – 36 kg/m2 or higher – appeared to protect people against developing the condition.
“As this class of medications becomes increasingly popular in the United States, it is important for providers to know which patients are at a higher or lower risk of developing acute pancreatitis after being started on them,” said lead study author Robert Postlethwaite, MD, a gastroenterology resident at the University of Texas Southwestern Medical Center, Dallas.
The findings were presented at the annual meeting of the American College of Gastroenterology in Charlotte, N.C., being held in person and virtually.
Popularity comes at a price
The U.S. Food and Drug Administration has approved two GLP-1s for weight management – liraglutide (Victoza) in 2014 and semaglutide (Wegovy) in 2021. They work by targeting areas of the brain that control food intake and appetite. Other GLP-1s approved to treat type 2 diabetes include dulaglutide (Trulicity) and two other formulations of semaglutide (Rybelsus and Ozempic).
The demand for Wegovy has been so great that there is an ongoing shortage of the medication in the United States.
Although GLP-1s demonstrate a favorable side-effect profile, compared with other types of antiobesity medications, acute pancreatitis remains a serious and sometimes life-threatening complication, the researchers note. Some patients require hospitalization.
Dr. Postlethwaite and colleagues performed a retrospective, single-center study of 2,245 patients who attended an academic medical center’s Weight Wellness program from 2015 to 2019. The average age was about 50 years, and 81% were female. The average BMI of all patients was 39.7 kg/m2.
The study only included patients starting GLP-1s for treating obesity, not for diabetes.
Of the 2,245 patients, 49 (2.2%) developed acute pancreatitis after starting a GLP-1.
A history of type 2 diabetes mellitus made acute pancreatitis twice as likely (95% confidence interval, 1.04-3.96; P = .04).
Stage 3 or higher chronic kidney disease increased risk 2.3 times (95% CI, 1.18-4.55; P = .01), while tobacco use upped it 3.3 times (95% CI, 1.70-6.50; P < .001).
In contrast, researchers found those with a BMI of 36-40 kg/m2 were 88% less likely to develop acute pancreatitis (95% CI, 0.07-0.67; P = .007), compared with patients with a BMI of less than or equal to 30 kg/m2. Patients with a BMI of greater than 40 kg/m2 had a 73% lower risk (95% CI, 0.10-0.73; P = .01).
Dr. Postlethwaite and colleagues found no association with age, sex, or history of bariatric surgery or acute pancreatitis.
Because a history of acute pancreatitis was not a risk factor, he advised that clinicians not withhold these medications for this reason, “especially given the significant glycemic, cardiovascular, and weight-loss effects.”
“We hope that we can arm clinicians with evidence in order to risk stratify their patients and determine who is at high risk of developing pancreatitis,” Dr. Postlethwaite said.
“Hopefully, we can prevent the development of pancreatitis in some patients, especially high-risk individuals, or at least allow clinicians to be aware of it in higher-risk patients to identify it early enough to prevent complications of acute pancreatitis,” he added.
Larger studies needed
The study is “promising,” said session comoderator Baharak Moshiree, MD, a gastroenterologist at Atrium Health, Charlotte, N.C., who was not affiliated with the research.
However, because the study was retrospective and relatively small, it needs to be validated in larger, prospective studies, she added.
“With obesity being such a global issue, there are many patients on these GLP-1 agonists,” Dr. Moshiree said.
Generally, these medications are prescribed by endocrinologists, not gastroenterologists, she noted, and she said that gastroenterologists should be aware of the risks associated with them, including minor gastrointestinal side effects, like nausea and vomiting, that can occur because of delayed gastric emptying.
Dr. Postlethwaite noted that being unable to assess how much alcohol or tobacco individuals used was a limitation. The relatively low proportion of people who developed acute pancreatitis in the study also means larger studies are warranted, he added.
Going forward, Dr. Postlethwaite and colleagues want to study the risks for each individual GLP-1 and other therapies used to control high blood sugar in people with type 2 diabetes, such as DPP4 (dipeptidyl-peptidase 4) inhibitors.
The study was independently supported. Dr. Postlethwaite and Dr. Moshiree report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
CHARLOTTE, N.C. – a new study has found.
Type 2 diabetes, advanced chronic kidney disease, and tobacco use were associated with greater risk for acute pancreatitis, researchers report.
On the other hand, a higher body mass index (BMI) – 36 kg/m2 or higher – appeared to protect people against developing the condition.
“As this class of medications becomes increasingly popular in the United States, it is important for providers to know which patients are at a higher or lower risk of developing acute pancreatitis after being started on them,” said lead study author Robert Postlethwaite, MD, a gastroenterology resident at the University of Texas Southwestern Medical Center, Dallas.
The findings were presented at the annual meeting of the American College of Gastroenterology in Charlotte, N.C., being held in person and virtually.
Popularity comes at a price
The U.S. Food and Drug Administration has approved two GLP-1s for weight management – liraglutide (Victoza) in 2014 and semaglutide (Wegovy) in 2021. They work by targeting areas of the brain that control food intake and appetite. Other GLP-1s approved to treat type 2 diabetes include dulaglutide (Trulicity) and two other formulations of semaglutide (Rybelsus and Ozempic).
The demand for Wegovy has been so great that there is an ongoing shortage of the medication in the United States.
Although GLP-1s demonstrate a favorable side-effect profile, compared with other types of antiobesity medications, acute pancreatitis remains a serious and sometimes life-threatening complication, the researchers note. Some patients require hospitalization.
Dr. Postlethwaite and colleagues performed a retrospective, single-center study of 2,245 patients who attended an academic medical center’s Weight Wellness program from 2015 to 2019. The average age was about 50 years, and 81% were female. The average BMI of all patients was 39.7 kg/m2.
The study only included patients starting GLP-1s for treating obesity, not for diabetes.
Of the 2,245 patients, 49 (2.2%) developed acute pancreatitis after starting a GLP-1.
A history of type 2 diabetes mellitus made acute pancreatitis twice as likely (95% confidence interval, 1.04-3.96; P = .04).
Stage 3 or higher chronic kidney disease increased risk 2.3 times (95% CI, 1.18-4.55; P = .01), while tobacco use upped it 3.3 times (95% CI, 1.70-6.50; P < .001).
In contrast, researchers found those with a BMI of 36-40 kg/m2 were 88% less likely to develop acute pancreatitis (95% CI, 0.07-0.67; P = .007), compared with patients with a BMI of less than or equal to 30 kg/m2. Patients with a BMI of greater than 40 kg/m2 had a 73% lower risk (95% CI, 0.10-0.73; P = .01).
Dr. Postlethwaite and colleagues found no association with age, sex, or history of bariatric surgery or acute pancreatitis.
Because a history of acute pancreatitis was not a risk factor, he advised that clinicians not withhold these medications for this reason, “especially given the significant glycemic, cardiovascular, and weight-loss effects.”
“We hope that we can arm clinicians with evidence in order to risk stratify their patients and determine who is at high risk of developing pancreatitis,” Dr. Postlethwaite said.
“Hopefully, we can prevent the development of pancreatitis in some patients, especially high-risk individuals, or at least allow clinicians to be aware of it in higher-risk patients to identify it early enough to prevent complications of acute pancreatitis,” he added.
Larger studies needed
The study is “promising,” said session comoderator Baharak Moshiree, MD, a gastroenterologist at Atrium Health, Charlotte, N.C., who was not affiliated with the research.
However, because the study was retrospective and relatively small, it needs to be validated in larger, prospective studies, she added.
“With obesity being such a global issue, there are many patients on these GLP-1 agonists,” Dr. Moshiree said.
Generally, these medications are prescribed by endocrinologists, not gastroenterologists, she noted, and she said that gastroenterologists should be aware of the risks associated with them, including minor gastrointestinal side effects, like nausea and vomiting, that can occur because of delayed gastric emptying.
Dr. Postlethwaite noted that being unable to assess how much alcohol or tobacco individuals used was a limitation. The relatively low proportion of people who developed acute pancreatitis in the study also means larger studies are warranted, he added.
Going forward, Dr. Postlethwaite and colleagues want to study the risks for each individual GLP-1 and other therapies used to control high blood sugar in people with type 2 diabetes, such as DPP4 (dipeptidyl-peptidase 4) inhibitors.
The study was independently supported. Dr. Postlethwaite and Dr. Moshiree report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
CHARLOTTE, N.C. – a new study has found.
Type 2 diabetes, advanced chronic kidney disease, and tobacco use were associated with greater risk for acute pancreatitis, researchers report.
On the other hand, a higher body mass index (BMI) – 36 kg/m2 or higher – appeared to protect people against developing the condition.
“As this class of medications becomes increasingly popular in the United States, it is important for providers to know which patients are at a higher or lower risk of developing acute pancreatitis after being started on them,” said lead study author Robert Postlethwaite, MD, a gastroenterology resident at the University of Texas Southwestern Medical Center, Dallas.
The findings were presented at the annual meeting of the American College of Gastroenterology in Charlotte, N.C., being held in person and virtually.
Popularity comes at a price
The U.S. Food and Drug Administration has approved two GLP-1s for weight management – liraglutide (Victoza) in 2014 and semaglutide (Wegovy) in 2021. They work by targeting areas of the brain that control food intake and appetite. Other GLP-1s approved to treat type 2 diabetes include dulaglutide (Trulicity) and two other formulations of semaglutide (Rybelsus and Ozempic).
The demand for Wegovy has been so great that there is an ongoing shortage of the medication in the United States.
Although GLP-1s demonstrate a favorable side-effect profile, compared with other types of antiobesity medications, acute pancreatitis remains a serious and sometimes life-threatening complication, the researchers note. Some patients require hospitalization.
Dr. Postlethwaite and colleagues performed a retrospective, single-center study of 2,245 patients who attended an academic medical center’s Weight Wellness program from 2015 to 2019. The average age was about 50 years, and 81% were female. The average BMI of all patients was 39.7 kg/m2.
The study only included patients starting GLP-1s for treating obesity, not for diabetes.
Of the 2,245 patients, 49 (2.2%) developed acute pancreatitis after starting a GLP-1.
A history of type 2 diabetes mellitus made acute pancreatitis twice as likely (95% confidence interval, 1.04-3.96; P = .04).
Stage 3 or higher chronic kidney disease increased risk 2.3 times (95% CI, 1.18-4.55; P = .01), while tobacco use upped it 3.3 times (95% CI, 1.70-6.50; P < .001).
In contrast, researchers found those with a BMI of 36-40 kg/m2 were 88% less likely to develop acute pancreatitis (95% CI, 0.07-0.67; P = .007), compared with patients with a BMI of less than or equal to 30 kg/m2. Patients with a BMI of greater than 40 kg/m2 had a 73% lower risk (95% CI, 0.10-0.73; P = .01).
Dr. Postlethwaite and colleagues found no association with age, sex, or history of bariatric surgery or acute pancreatitis.
Because a history of acute pancreatitis was not a risk factor, he advised that clinicians not withhold these medications for this reason, “especially given the significant glycemic, cardiovascular, and weight-loss effects.”
“We hope that we can arm clinicians with evidence in order to risk stratify their patients and determine who is at high risk of developing pancreatitis,” Dr. Postlethwaite said.
“Hopefully, we can prevent the development of pancreatitis in some patients, especially high-risk individuals, or at least allow clinicians to be aware of it in higher-risk patients to identify it early enough to prevent complications of acute pancreatitis,” he added.
Larger studies needed
The study is “promising,” said session comoderator Baharak Moshiree, MD, a gastroenterologist at Atrium Health, Charlotte, N.C., who was not affiliated with the research.
However, because the study was retrospective and relatively small, it needs to be validated in larger, prospective studies, she added.
“With obesity being such a global issue, there are many patients on these GLP-1 agonists,” Dr. Moshiree said.
Generally, these medications are prescribed by endocrinologists, not gastroenterologists, she noted, and she said that gastroenterologists should be aware of the risks associated with them, including minor gastrointestinal side effects, like nausea and vomiting, that can occur because of delayed gastric emptying.
Dr. Postlethwaite noted that being unable to assess how much alcohol or tobacco individuals used was a limitation. The relatively low proportion of people who developed acute pancreatitis in the study also means larger studies are warranted, he added.
Going forward, Dr. Postlethwaite and colleagues want to study the risks for each individual GLP-1 and other therapies used to control high blood sugar in people with type 2 diabetes, such as DPP4 (dipeptidyl-peptidase 4) inhibitors.
The study was independently supported. Dr. Postlethwaite and Dr. Moshiree report no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM ACG 2022
Death of son reinforces flu vaccination message
“It was what the CDC [Centers for Disease Control and Prevention] would call classic influenza-like illness,” Dr. Teichman said. “It was too late to start antivirals, so I gave him advice on symptomatic treatment. We texted the next day, and I was glad to hear that his fever was trending down and that he was feeling a little bit better.”
Two days later, his son called again.
“He said he was having trouble breathing, and over the phone I could hear him hyperventilating.” The retired pediatrician and health care executive told his son to seek medical care.
“Then I got the call that no parent wants to get.”
Brent’s cousin Jake called saying he couldn’t wake Brent up.
“I called Jake back a few minutes later and asked him to hold up the phone,” Dr. Teichman said. “I listened to EMS working on my son, calling for round after round of many medications. He was in arrest and they couldn’t revive him.”
“To this day when I close my eyes at night, I still hear the beeping of those monitors.”
Brent had no health conditions to put him at higher risk for complications of the flu. “Brent was a wonderful son, brother, uncle, and friend. He had a passion for everything he did, and that included his chosen calling of the culinary arts but also included University of Kentucky sports,” Dr. Teichman said.
Brent planned to get a flu vaccine but had not done it yet. “In his obituary, we requested that, in lieu of flowers or donations, people go get their flu shot,” Dr. Teichman said.
“I’m here today to put a face on influenza,” Dr. Teichman said at a news briefing Oct. 4 on preventing the flu and pneumococcal disease, sponsored by the National Foundation for Infectious Diseases.
New survey numbers ‘alarming’
The NFID commissioned a national survey of more than 1,000 U.S. adults to better understand their knowledge and attitudes about the flu, pneumococcal disease, vaccines, and the impact of COVID-19.
“We were alarmed to learn that only 49% of U.S. adults plan to get their flu vaccine this season,” said Patricia A. “Patsy” Stinchfield, a registered nurse, NFID president, and moderator of the news briefing. “That is not good enough.”
In addition, 22% of people at higher risk for flu-related complications do not plan to get vaccinated this season. “That’s a dangerous risk to take,” Ms. Stinchfield said.
An encouraging finding, she said, is that 69% of adults surveyed recognize that an annual flu vaccination is the best way to prevent flu-related hospitalizations and death.
“So, most people know what to do. We just need to do it,” she said.
The top reason for not getting a flu shot in 2022 mentioned by 41% of people surveyed, is they do not think vaccines work very well. Another 39% are concerned about vaccine side effects, and 28% skip the vaccine because they “never get the flu.”
The experts on the panel emphasized the recommendation that all Americans 6 months or older get the flu vaccine, preferably by the end of October. Vaccination is especially important for those at higher risk of complications from the flu, including children under 5, pregnant women, people with one or more health conditions, the immunocompromised, and Americans 65 years and older.
Ms. Stinchfield acknowledged that the effectiveness of the flu vaccine varies season to season, but even if the vaccine does not completely match the circulating viruses, it can help prevent serious outcomes like hospitalization and death. One of the serious potential complications is pneumonia or “pneumococcal disease.”
“Our survey shows that only 29% of those at risk have been advised to receive a pneumococcal vaccine,” Ms. Stinchfield said. “The good news is that, among those who were advised to get the vaccine, 74% did receive their pneumococcal vaccine,” she said. “This underscores a key point to you, my fellow clinicians: As health professionals, our recommendations matter.”
Higher doses for 65+ Americans
The CDC updated recommendations this flu season for adults 65 and older to receive one of three preferentially recommended flu vaccines, said CDC Director Rochelle Walensky, MD. The CDC is recommending higher-dose, stronger vaccines for older Americans “based on a review of the available studies, which suggested that in this age group, these vaccines are potentially more effective than standard-dose ... vaccines.”
During most seasons, people 65 and older bear the greatest burden of severe flu disease, accounting for most flu-related hospitalizations and deaths.
“They are the largest vulnerable segment of our society,” Dr. Walensky said.
What will this flu season be like?
Health officials in the flu vaccine business also tend to be in the flu season prediction business. That includes Dr. Walensky.
“While we will never exactly know what each flu season will hold, we do know that every year, the best way you can protect yourself and those around you is to get your annual flu vaccine,” she said while taking part remotely in the briefing.
How severe will the flu season be in 2022-23? William Schaffner, MD, said he gets that question a lot. “Don’t think about that. Just focus on the fact that flu will be with us each year.
“We were a little bit spoiled. We’ve had two mild influenza seasons,” said Dr. Schaffner, medical director of NFID and a professor of infectious diseases and preventive medicine at Vanderbilt University, Nashville, Tenn. “I think with all the interest in COVID, people have rather forgotten about influenza. I’ve had to remind them that this is yet another serious winter respiratory virus.
“As I like to say, flu is fickle. It’s difficult to predict how serious this next outbreak of influenza this season is going to be. We could look at what happened in the Southern Hemisphere,” he said.
For example, Australia had the worst influenza season in the past 5 years, Schaffner said. “If you want a hint of what might happen here and you want yet another reason to be vaccinated, there it is.”
What we do know, Dr. Walensky said, is that the timing and severity of the past two flu seasons in the U.S. have been different than typical flu seasons. “And this is likely due to the COVID mitigation measures and other changes in circulating respiratory viruses.” Also, although last flu season was “relatively mild,” there was more flu activity than in the prior, 2020-21 season.
Also, Dr. Walensky said, last season’s flu cases began to increase in November and remained elevated until mid-June, “making it the latest season on record.”
The official cause of Brent Teichman’s death was multilobar pneumonia, cause undetermined. “But after 30-plus years as a pediatrician ... I know influenza when I see it,” Dr. Teichman said.
“There’s a hole in our hearts that will never heal. Loss of a child is devastating,” he said. The flu “can take the life of a healthy young person, as it did to my son.
“And for all those listening to my story who are vaccine hesitant, do it for those who love you. So that they won’t walk the path that we and many other families in this country have walked.”
To prove their point, Dr. Teichman and Ms. Stinchfield raised their sleeves and received flu shots during the news briefing.
“This one is for Brent,” Dr. Teichman said.
A version of this article first appeared on WebMD.com.
“It was what the CDC [Centers for Disease Control and Prevention] would call classic influenza-like illness,” Dr. Teichman said. “It was too late to start antivirals, so I gave him advice on symptomatic treatment. We texted the next day, and I was glad to hear that his fever was trending down and that he was feeling a little bit better.”
Two days later, his son called again.
“He said he was having trouble breathing, and over the phone I could hear him hyperventilating.” The retired pediatrician and health care executive told his son to seek medical care.
“Then I got the call that no parent wants to get.”
Brent’s cousin Jake called saying he couldn’t wake Brent up.
“I called Jake back a few minutes later and asked him to hold up the phone,” Dr. Teichman said. “I listened to EMS working on my son, calling for round after round of many medications. He was in arrest and they couldn’t revive him.”
“To this day when I close my eyes at night, I still hear the beeping of those monitors.”
Brent had no health conditions to put him at higher risk for complications of the flu. “Brent was a wonderful son, brother, uncle, and friend. He had a passion for everything he did, and that included his chosen calling of the culinary arts but also included University of Kentucky sports,” Dr. Teichman said.
Brent planned to get a flu vaccine but had not done it yet. “In his obituary, we requested that, in lieu of flowers or donations, people go get their flu shot,” Dr. Teichman said.
“I’m here today to put a face on influenza,” Dr. Teichman said at a news briefing Oct. 4 on preventing the flu and pneumococcal disease, sponsored by the National Foundation for Infectious Diseases.
New survey numbers ‘alarming’
The NFID commissioned a national survey of more than 1,000 U.S. adults to better understand their knowledge and attitudes about the flu, pneumococcal disease, vaccines, and the impact of COVID-19.
“We were alarmed to learn that only 49% of U.S. adults plan to get their flu vaccine this season,” said Patricia A. “Patsy” Stinchfield, a registered nurse, NFID president, and moderator of the news briefing. “That is not good enough.”
In addition, 22% of people at higher risk for flu-related complications do not plan to get vaccinated this season. “That’s a dangerous risk to take,” Ms. Stinchfield said.
An encouraging finding, she said, is that 69% of adults surveyed recognize that an annual flu vaccination is the best way to prevent flu-related hospitalizations and death.
“So, most people know what to do. We just need to do it,” she said.
The top reason for not getting a flu shot in 2022 mentioned by 41% of people surveyed, is they do not think vaccines work very well. Another 39% are concerned about vaccine side effects, and 28% skip the vaccine because they “never get the flu.”
The experts on the panel emphasized the recommendation that all Americans 6 months or older get the flu vaccine, preferably by the end of October. Vaccination is especially important for those at higher risk of complications from the flu, including children under 5, pregnant women, people with one or more health conditions, the immunocompromised, and Americans 65 years and older.
Ms. Stinchfield acknowledged that the effectiveness of the flu vaccine varies season to season, but even if the vaccine does not completely match the circulating viruses, it can help prevent serious outcomes like hospitalization and death. One of the serious potential complications is pneumonia or “pneumococcal disease.”
“Our survey shows that only 29% of those at risk have been advised to receive a pneumococcal vaccine,” Ms. Stinchfield said. “The good news is that, among those who were advised to get the vaccine, 74% did receive their pneumococcal vaccine,” she said. “This underscores a key point to you, my fellow clinicians: As health professionals, our recommendations matter.”
Higher doses for 65+ Americans
The CDC updated recommendations this flu season for adults 65 and older to receive one of three preferentially recommended flu vaccines, said CDC Director Rochelle Walensky, MD. The CDC is recommending higher-dose, stronger vaccines for older Americans “based on a review of the available studies, which suggested that in this age group, these vaccines are potentially more effective than standard-dose ... vaccines.”
During most seasons, people 65 and older bear the greatest burden of severe flu disease, accounting for most flu-related hospitalizations and deaths.
“They are the largest vulnerable segment of our society,” Dr. Walensky said.
What will this flu season be like?
Health officials in the flu vaccine business also tend to be in the flu season prediction business. That includes Dr. Walensky.
“While we will never exactly know what each flu season will hold, we do know that every year, the best way you can protect yourself and those around you is to get your annual flu vaccine,” she said while taking part remotely in the briefing.
How severe will the flu season be in 2022-23? William Schaffner, MD, said he gets that question a lot. “Don’t think about that. Just focus on the fact that flu will be with us each year.
“We were a little bit spoiled. We’ve had two mild influenza seasons,” said Dr. Schaffner, medical director of NFID and a professor of infectious diseases and preventive medicine at Vanderbilt University, Nashville, Tenn. “I think with all the interest in COVID, people have rather forgotten about influenza. I’ve had to remind them that this is yet another serious winter respiratory virus.
“As I like to say, flu is fickle. It’s difficult to predict how serious this next outbreak of influenza this season is going to be. We could look at what happened in the Southern Hemisphere,” he said.
For example, Australia had the worst influenza season in the past 5 years, Schaffner said. “If you want a hint of what might happen here and you want yet another reason to be vaccinated, there it is.”
What we do know, Dr. Walensky said, is that the timing and severity of the past two flu seasons in the U.S. have been different than typical flu seasons. “And this is likely due to the COVID mitigation measures and other changes in circulating respiratory viruses.” Also, although last flu season was “relatively mild,” there was more flu activity than in the prior, 2020-21 season.
Also, Dr. Walensky said, last season’s flu cases began to increase in November and remained elevated until mid-June, “making it the latest season on record.”
The official cause of Brent Teichman’s death was multilobar pneumonia, cause undetermined. “But after 30-plus years as a pediatrician ... I know influenza when I see it,” Dr. Teichman said.
“There’s a hole in our hearts that will never heal. Loss of a child is devastating,” he said. The flu “can take the life of a healthy young person, as it did to my son.
“And for all those listening to my story who are vaccine hesitant, do it for those who love you. So that they won’t walk the path that we and many other families in this country have walked.”
To prove their point, Dr. Teichman and Ms. Stinchfield raised their sleeves and received flu shots during the news briefing.
“This one is for Brent,” Dr. Teichman said.
A version of this article first appeared on WebMD.com.
“It was what the CDC [Centers for Disease Control and Prevention] would call classic influenza-like illness,” Dr. Teichman said. “It was too late to start antivirals, so I gave him advice on symptomatic treatment. We texted the next day, and I was glad to hear that his fever was trending down and that he was feeling a little bit better.”
Two days later, his son called again.
“He said he was having trouble breathing, and over the phone I could hear him hyperventilating.” The retired pediatrician and health care executive told his son to seek medical care.
“Then I got the call that no parent wants to get.”
Brent’s cousin Jake called saying he couldn’t wake Brent up.
“I called Jake back a few minutes later and asked him to hold up the phone,” Dr. Teichman said. “I listened to EMS working on my son, calling for round after round of many medications. He was in arrest and they couldn’t revive him.”
“To this day when I close my eyes at night, I still hear the beeping of those monitors.”
Brent had no health conditions to put him at higher risk for complications of the flu. “Brent was a wonderful son, brother, uncle, and friend. He had a passion for everything he did, and that included his chosen calling of the culinary arts but also included University of Kentucky sports,” Dr. Teichman said.
Brent planned to get a flu vaccine but had not done it yet. “In his obituary, we requested that, in lieu of flowers or donations, people go get their flu shot,” Dr. Teichman said.
“I’m here today to put a face on influenza,” Dr. Teichman said at a news briefing Oct. 4 on preventing the flu and pneumococcal disease, sponsored by the National Foundation for Infectious Diseases.
New survey numbers ‘alarming’
The NFID commissioned a national survey of more than 1,000 U.S. adults to better understand their knowledge and attitudes about the flu, pneumococcal disease, vaccines, and the impact of COVID-19.
“We were alarmed to learn that only 49% of U.S. adults plan to get their flu vaccine this season,” said Patricia A. “Patsy” Stinchfield, a registered nurse, NFID president, and moderator of the news briefing. “That is not good enough.”
In addition, 22% of people at higher risk for flu-related complications do not plan to get vaccinated this season. “That’s a dangerous risk to take,” Ms. Stinchfield said.
An encouraging finding, she said, is that 69% of adults surveyed recognize that an annual flu vaccination is the best way to prevent flu-related hospitalizations and death.
“So, most people know what to do. We just need to do it,” she said.
The top reason for not getting a flu shot in 2022 mentioned by 41% of people surveyed, is they do not think vaccines work very well. Another 39% are concerned about vaccine side effects, and 28% skip the vaccine because they “never get the flu.”
The experts on the panel emphasized the recommendation that all Americans 6 months or older get the flu vaccine, preferably by the end of October. Vaccination is especially important for those at higher risk of complications from the flu, including children under 5, pregnant women, people with one or more health conditions, the immunocompromised, and Americans 65 years and older.
Ms. Stinchfield acknowledged that the effectiveness of the flu vaccine varies season to season, but even if the vaccine does not completely match the circulating viruses, it can help prevent serious outcomes like hospitalization and death. One of the serious potential complications is pneumonia or “pneumococcal disease.”
“Our survey shows that only 29% of those at risk have been advised to receive a pneumococcal vaccine,” Ms. Stinchfield said. “The good news is that, among those who were advised to get the vaccine, 74% did receive their pneumococcal vaccine,” she said. “This underscores a key point to you, my fellow clinicians: As health professionals, our recommendations matter.”
Higher doses for 65+ Americans
The CDC updated recommendations this flu season for adults 65 and older to receive one of three preferentially recommended flu vaccines, said CDC Director Rochelle Walensky, MD. The CDC is recommending higher-dose, stronger vaccines for older Americans “based on a review of the available studies, which suggested that in this age group, these vaccines are potentially more effective than standard-dose ... vaccines.”
During most seasons, people 65 and older bear the greatest burden of severe flu disease, accounting for most flu-related hospitalizations and deaths.
“They are the largest vulnerable segment of our society,” Dr. Walensky said.
What will this flu season be like?
Health officials in the flu vaccine business also tend to be in the flu season prediction business. That includes Dr. Walensky.
“While we will never exactly know what each flu season will hold, we do know that every year, the best way you can protect yourself and those around you is to get your annual flu vaccine,” she said while taking part remotely in the briefing.
How severe will the flu season be in 2022-23? William Schaffner, MD, said he gets that question a lot. “Don’t think about that. Just focus on the fact that flu will be with us each year.
“We were a little bit spoiled. We’ve had two mild influenza seasons,” said Dr. Schaffner, medical director of NFID and a professor of infectious diseases and preventive medicine at Vanderbilt University, Nashville, Tenn. “I think with all the interest in COVID, people have rather forgotten about influenza. I’ve had to remind them that this is yet another serious winter respiratory virus.
“As I like to say, flu is fickle. It’s difficult to predict how serious this next outbreak of influenza this season is going to be. We could look at what happened in the Southern Hemisphere,” he said.
For example, Australia had the worst influenza season in the past 5 years, Schaffner said. “If you want a hint of what might happen here and you want yet another reason to be vaccinated, there it is.”
What we do know, Dr. Walensky said, is that the timing and severity of the past two flu seasons in the U.S. have been different than typical flu seasons. “And this is likely due to the COVID mitigation measures and other changes in circulating respiratory viruses.” Also, although last flu season was “relatively mild,” there was more flu activity than in the prior, 2020-21 season.
Also, Dr. Walensky said, last season’s flu cases began to increase in November and remained elevated until mid-June, “making it the latest season on record.”
The official cause of Brent Teichman’s death was multilobar pneumonia, cause undetermined. “But after 30-plus years as a pediatrician ... I know influenza when I see it,” Dr. Teichman said.
“There’s a hole in our hearts that will never heal. Loss of a child is devastating,” he said. The flu “can take the life of a healthy young person, as it did to my son.
“And for all those listening to my story who are vaccine hesitant, do it for those who love you. So that they won’t walk the path that we and many other families in this country have walked.”
To prove their point, Dr. Teichman and Ms. Stinchfield raised their sleeves and received flu shots during the news briefing.
“This one is for Brent,” Dr. Teichman said.
A version of this article first appeared on WebMD.com.
FDA authorizes updated COVID boosters to target newest variants
The agency cited data to support the safety and efficacy of this next generation of mRNA vaccines targeted toward variants of concern.
The Pfizer EUA corresponds to the company’s combination booster shot that includes the original COVID-19 vaccine as well as a vaccine specifically designed to protect against the most recent Omicron variants, BA.4 and BA.5.
The Moderna combination vaccine will contain both the firm’s original COVID-19 vaccine and a vaccine to protect specifically against Omicron BA.4 and BA.5 subvariants.
As of Aug. 27, BA.4 and BA.4.6 account for about 11% of circulating variants and BA.5 accounts for almost all the remaining 89%, Centers for Disease Control and Prevention data show.
The next step will be review of the scientific data by the CDC’s Advisory Committee on Immunization Practices, which is set to meet Sept. 1 and 2. The final hurdle before distribution of the new vaccines will be sign-off on CDC recommendations for use by agency Director Rochelle Walensky, MD.
This is a developing story. A version of this article first appeared on WebMD.com.
The agency cited data to support the safety and efficacy of this next generation of mRNA vaccines targeted toward variants of concern.
The Pfizer EUA corresponds to the company’s combination booster shot that includes the original COVID-19 vaccine as well as a vaccine specifically designed to protect against the most recent Omicron variants, BA.4 and BA.5.
The Moderna combination vaccine will contain both the firm’s original COVID-19 vaccine and a vaccine to protect specifically against Omicron BA.4 and BA.5 subvariants.
As of Aug. 27, BA.4 and BA.4.6 account for about 11% of circulating variants and BA.5 accounts for almost all the remaining 89%, Centers for Disease Control and Prevention data show.
The next step will be review of the scientific data by the CDC’s Advisory Committee on Immunization Practices, which is set to meet Sept. 1 and 2. The final hurdle before distribution of the new vaccines will be sign-off on CDC recommendations for use by agency Director Rochelle Walensky, MD.
This is a developing story. A version of this article first appeared on WebMD.com.
The agency cited data to support the safety and efficacy of this next generation of mRNA vaccines targeted toward variants of concern.
The Pfizer EUA corresponds to the company’s combination booster shot that includes the original COVID-19 vaccine as well as a vaccine specifically designed to protect against the most recent Omicron variants, BA.4 and BA.5.
The Moderna combination vaccine will contain both the firm’s original COVID-19 vaccine and a vaccine to protect specifically against Omicron BA.4 and BA.5 subvariants.
As of Aug. 27, BA.4 and BA.4.6 account for about 11% of circulating variants and BA.5 accounts for almost all the remaining 89%, Centers for Disease Control and Prevention data show.
The next step will be review of the scientific data by the CDC’s Advisory Committee on Immunization Practices, which is set to meet Sept. 1 and 2. The final hurdle before distribution of the new vaccines will be sign-off on CDC recommendations for use by agency Director Rochelle Walensky, MD.
This is a developing story. A version of this article first appeared on WebMD.com.
Hearing aids available in October without a prescription
The White House announced today that the Food and Drug Administration will move forward with plans to make hearing aids available over the counter in pharmacies, other retail locations, and online.
This major milestone aims to make hearing aids easier to buy and more affordable, potentially saving families thousands of dollars.
An estimated 28.8 million U.S. adults could benefit from using hearing aids, according to numbers from the National Institute on Deafness and Other Communication Disorders. But only about 16% of people aged 20-69 years who could be helped by hearing aids have ever used them.
The risk for hearing loss increases with age. Among Americans ages 70 and older, only 30% who could hear better with these devices have ever used them, the institute reports.
Once the FDA final rule takes effect, Americans with mild to moderate hearing loss will be able to buy a hearing aid without a doctor’s exam, prescription, or fitting adjustment.
President Joe Biden announced in 2021 he intended to allow hearing aids to be sold over the counter without a prescription to increase competition among manufacturers. Congress also passed bipartisan legislation in 2017 requiring the FDA to create a new category for hearing aids sold directly to consumers. Some devices intended for minors or people with severe hearing loss will remain available only with a prescription.
“This action makes good on my commitment to lower costs for American families, delivering nearly $3,000 in savings to American families for a pair of hearing aids and giving people more choices to improve their health and wellbeing,” the president said in a statement announcing the news.
The new over-the-counter hearing aids will be considered medical devices. To avoid confusion, the FDA explains the differences between hearing aids and personal sound amplification products (PSAPs). For example, PSAPs are considered electronic devices designed for people with normal hearing to use in certain situations, like birdwatching or hunting.
A version of this article first appeared on WebMD.com.
The White House announced today that the Food and Drug Administration will move forward with plans to make hearing aids available over the counter in pharmacies, other retail locations, and online.
This major milestone aims to make hearing aids easier to buy and more affordable, potentially saving families thousands of dollars.
An estimated 28.8 million U.S. adults could benefit from using hearing aids, according to numbers from the National Institute on Deafness and Other Communication Disorders. But only about 16% of people aged 20-69 years who could be helped by hearing aids have ever used them.
The risk for hearing loss increases with age. Among Americans ages 70 and older, only 30% who could hear better with these devices have ever used them, the institute reports.
Once the FDA final rule takes effect, Americans with mild to moderate hearing loss will be able to buy a hearing aid without a doctor’s exam, prescription, or fitting adjustment.
President Joe Biden announced in 2021 he intended to allow hearing aids to be sold over the counter without a prescription to increase competition among manufacturers. Congress also passed bipartisan legislation in 2017 requiring the FDA to create a new category for hearing aids sold directly to consumers. Some devices intended for minors or people with severe hearing loss will remain available only with a prescription.
“This action makes good on my commitment to lower costs for American families, delivering nearly $3,000 in savings to American families for a pair of hearing aids and giving people more choices to improve their health and wellbeing,” the president said in a statement announcing the news.
The new over-the-counter hearing aids will be considered medical devices. To avoid confusion, the FDA explains the differences between hearing aids and personal sound amplification products (PSAPs). For example, PSAPs are considered electronic devices designed for people with normal hearing to use in certain situations, like birdwatching or hunting.
A version of this article first appeared on WebMD.com.
The White House announced today that the Food and Drug Administration will move forward with plans to make hearing aids available over the counter in pharmacies, other retail locations, and online.
This major milestone aims to make hearing aids easier to buy and more affordable, potentially saving families thousands of dollars.
An estimated 28.8 million U.S. adults could benefit from using hearing aids, according to numbers from the National Institute on Deafness and Other Communication Disorders. But only about 16% of people aged 20-69 years who could be helped by hearing aids have ever used them.
The risk for hearing loss increases with age. Among Americans ages 70 and older, only 30% who could hear better with these devices have ever used them, the institute reports.
Once the FDA final rule takes effect, Americans with mild to moderate hearing loss will be able to buy a hearing aid without a doctor’s exam, prescription, or fitting adjustment.
President Joe Biden announced in 2021 he intended to allow hearing aids to be sold over the counter without a prescription to increase competition among manufacturers. Congress also passed bipartisan legislation in 2017 requiring the FDA to create a new category for hearing aids sold directly to consumers. Some devices intended for minors or people with severe hearing loss will remain available only with a prescription.
“This action makes good on my commitment to lower costs for American families, delivering nearly $3,000 in savings to American families for a pair of hearing aids and giving people more choices to improve their health and wellbeing,” the president said in a statement announcing the news.
The new over-the-counter hearing aids will be considered medical devices. To avoid confusion, the FDA explains the differences between hearing aids and personal sound amplification products (PSAPs). For example, PSAPs are considered electronic devices designed for people with normal hearing to use in certain situations, like birdwatching or hunting.
A version of this article first appeared on WebMD.com.
Many saw ‘meaningful’ weight loss from 12-week online program
developed by researchers at Brown University.
Primary care doctors offered the free obesity treatment program during routine care. Each week, people reported weight changes and activity and calorie consumption; attended online lessons; and received personalized feedback.
The 464 people who took part for at least 1 week lost an average of 5% of their body weight. And those who followed the plan all 12 weeks lost an average of 7%.
The researchers point out this short-term weight loss was achieved without any face-to-face counseling, which can limit weight management in busy primary care settings.
“Obesity is a highly stigmatized condition,” says lead investigator J. Graham Thomas, PhD.
People take part in the Rx Weight Loss program in the privacy of their own homes. He says this not only makes it more convenient but could be an advantage for people who feel uncomfortable managing their weight around others.
Ideally, health care providers could offer the online program as an opportunity to patients “as opposed to something punitive,” says Dr. Thomas, a researcher at the Weight Control and Diabetes Research Center at Miriam Hospital in Providence, R.I.
The study was published online in the journal Obesity.
In three previous controlled clinical trials led by the same research team, the weight-loss program was linked to average weight losses of 4.2% to 5.8%. In the current study, the researchers were not directly involved, and Dr. Thomas says he was encouraged that the doctor-led initiative led to similar results.
About 11 pounds lost
Patients were offered the program during routine care by doctors in the Rhode Island Primary Care Physicians Corporation, which includes 100 doctors at 60 sites. To be eligible, people had to be 18-75 years old, have Internet access, be fluent in English, and have a body mass index (BMI) of 25 kg/m2 or greater.
The average age of the people in the study was 53, 70% were women, and the average BMI was 36.2.
A BMI of 25 or above means you are overweight, while those with a BMI of 30 or higher are considered obese.
The average 5.1% decrease in body weight at 12 weeks translated to just more than 11 pounds of average weight loss.
‘Very encouraging’
The results of the study are “very encouraging,” says Gareth R. Dutton, PhD, who was not affiliated with the study.
Previous strategies had limits, he says.
“Fully automated interventions that have no staff contact with participants often achieve modest weight loss,” says Dr. Dutton, a professor of medicine and investigator in the Nutrition Obesity Research Center at the University of Alabama at Birmingham.
Weight-loss programs recommended by primary care doctors have often performed even worse, he says.
“Weight-loss interventions delivered through primary care are challenging because of many barriers, including limited resources and time,” says Dr. Dutton, who is also lead investigator of a study that aims to enroll 400 primary care patients to compare daily self-weighing with standard care.
Letting doctors and their staff refer patients to an evidence-based weight-loss program has great potential, he says.
Looking to improve uptake
The Rx Weight Loss program was offered to 1,721 primary care patients overall.
When asked why only 26% of people offered the program agreed to participate, Dr. Thomas replied, “No matter how good the program is, it’s just never going to be the right time for a lot of people to add this to their lives, particularly given the last couple of years where folks are experiencing a lot of challenges and a lot of stressors.”
“Even though it’s an online program, addressing obesity always involves making substantial changes to eating and activity patterns,” he said.
Future steps
The investigators plan to look into ways to get more people to take part in the program.
It is not yet available for widespread use by others, but that’s the goal. Dr. Thomas said they learned ways during the study to make the fully automated, online program easier for others to adopt.
Measuring any effect on weight loss at 1 year is the primary aim of the study. “I think we expect to find something similar to what we see in previous studies, which is that a certain amount of weight regain will be the norm” at 1 year, Dr. Thomas said.
“But a certain amount of weight loss and associated health benefits will persist, making it worthwhile even if, on average, some gradual regain occurs.”A version of this article first appeared on WebMD.com.
developed by researchers at Brown University.
Primary care doctors offered the free obesity treatment program during routine care. Each week, people reported weight changes and activity and calorie consumption; attended online lessons; and received personalized feedback.
The 464 people who took part for at least 1 week lost an average of 5% of their body weight. And those who followed the plan all 12 weeks lost an average of 7%.
The researchers point out this short-term weight loss was achieved without any face-to-face counseling, which can limit weight management in busy primary care settings.
“Obesity is a highly stigmatized condition,” says lead investigator J. Graham Thomas, PhD.
People take part in the Rx Weight Loss program in the privacy of their own homes. He says this not only makes it more convenient but could be an advantage for people who feel uncomfortable managing their weight around others.
Ideally, health care providers could offer the online program as an opportunity to patients “as opposed to something punitive,” says Dr. Thomas, a researcher at the Weight Control and Diabetes Research Center at Miriam Hospital in Providence, R.I.
The study was published online in the journal Obesity.
In three previous controlled clinical trials led by the same research team, the weight-loss program was linked to average weight losses of 4.2% to 5.8%. In the current study, the researchers were not directly involved, and Dr. Thomas says he was encouraged that the doctor-led initiative led to similar results.
About 11 pounds lost
Patients were offered the program during routine care by doctors in the Rhode Island Primary Care Physicians Corporation, which includes 100 doctors at 60 sites. To be eligible, people had to be 18-75 years old, have Internet access, be fluent in English, and have a body mass index (BMI) of 25 kg/m2 or greater.
The average age of the people in the study was 53, 70% were women, and the average BMI was 36.2.
A BMI of 25 or above means you are overweight, while those with a BMI of 30 or higher are considered obese.
The average 5.1% decrease in body weight at 12 weeks translated to just more than 11 pounds of average weight loss.
‘Very encouraging’
The results of the study are “very encouraging,” says Gareth R. Dutton, PhD, who was not affiliated with the study.
Previous strategies had limits, he says.
“Fully automated interventions that have no staff contact with participants often achieve modest weight loss,” says Dr. Dutton, a professor of medicine and investigator in the Nutrition Obesity Research Center at the University of Alabama at Birmingham.
Weight-loss programs recommended by primary care doctors have often performed even worse, he says.
“Weight-loss interventions delivered through primary care are challenging because of many barriers, including limited resources and time,” says Dr. Dutton, who is also lead investigator of a study that aims to enroll 400 primary care patients to compare daily self-weighing with standard care.
Letting doctors and their staff refer patients to an evidence-based weight-loss program has great potential, he says.
Looking to improve uptake
The Rx Weight Loss program was offered to 1,721 primary care patients overall.
When asked why only 26% of people offered the program agreed to participate, Dr. Thomas replied, “No matter how good the program is, it’s just never going to be the right time for a lot of people to add this to their lives, particularly given the last couple of years where folks are experiencing a lot of challenges and a lot of stressors.”
“Even though it’s an online program, addressing obesity always involves making substantial changes to eating and activity patterns,” he said.
Future steps
The investigators plan to look into ways to get more people to take part in the program.
It is not yet available for widespread use by others, but that’s the goal. Dr. Thomas said they learned ways during the study to make the fully automated, online program easier for others to adopt.
Measuring any effect on weight loss at 1 year is the primary aim of the study. “I think we expect to find something similar to what we see in previous studies, which is that a certain amount of weight regain will be the norm” at 1 year, Dr. Thomas said.
“But a certain amount of weight loss and associated health benefits will persist, making it worthwhile even if, on average, some gradual regain occurs.”A version of this article first appeared on WebMD.com.
developed by researchers at Brown University.
Primary care doctors offered the free obesity treatment program during routine care. Each week, people reported weight changes and activity and calorie consumption; attended online lessons; and received personalized feedback.
The 464 people who took part for at least 1 week lost an average of 5% of their body weight. And those who followed the plan all 12 weeks lost an average of 7%.
The researchers point out this short-term weight loss was achieved without any face-to-face counseling, which can limit weight management in busy primary care settings.
“Obesity is a highly stigmatized condition,” says lead investigator J. Graham Thomas, PhD.
People take part in the Rx Weight Loss program in the privacy of their own homes. He says this not only makes it more convenient but could be an advantage for people who feel uncomfortable managing their weight around others.
Ideally, health care providers could offer the online program as an opportunity to patients “as opposed to something punitive,” says Dr. Thomas, a researcher at the Weight Control and Diabetes Research Center at Miriam Hospital in Providence, R.I.
The study was published online in the journal Obesity.
In three previous controlled clinical trials led by the same research team, the weight-loss program was linked to average weight losses of 4.2% to 5.8%. In the current study, the researchers were not directly involved, and Dr. Thomas says he was encouraged that the doctor-led initiative led to similar results.
About 11 pounds lost
Patients were offered the program during routine care by doctors in the Rhode Island Primary Care Physicians Corporation, which includes 100 doctors at 60 sites. To be eligible, people had to be 18-75 years old, have Internet access, be fluent in English, and have a body mass index (BMI) of 25 kg/m2 or greater.
The average age of the people in the study was 53, 70% were women, and the average BMI was 36.2.
A BMI of 25 or above means you are overweight, while those with a BMI of 30 or higher are considered obese.
The average 5.1% decrease in body weight at 12 weeks translated to just more than 11 pounds of average weight loss.
‘Very encouraging’
The results of the study are “very encouraging,” says Gareth R. Dutton, PhD, who was not affiliated with the study.
Previous strategies had limits, he says.
“Fully automated interventions that have no staff contact with participants often achieve modest weight loss,” says Dr. Dutton, a professor of medicine and investigator in the Nutrition Obesity Research Center at the University of Alabama at Birmingham.
Weight-loss programs recommended by primary care doctors have often performed even worse, he says.
“Weight-loss interventions delivered through primary care are challenging because of many barriers, including limited resources and time,” says Dr. Dutton, who is also lead investigator of a study that aims to enroll 400 primary care patients to compare daily self-weighing with standard care.
Letting doctors and their staff refer patients to an evidence-based weight-loss program has great potential, he says.
Looking to improve uptake
The Rx Weight Loss program was offered to 1,721 primary care patients overall.
When asked why only 26% of people offered the program agreed to participate, Dr. Thomas replied, “No matter how good the program is, it’s just never going to be the right time for a lot of people to add this to their lives, particularly given the last couple of years where folks are experiencing a lot of challenges and a lot of stressors.”
“Even though it’s an online program, addressing obesity always involves making substantial changes to eating and activity patterns,” he said.
Future steps
The investigators plan to look into ways to get more people to take part in the program.
It is not yet available for widespread use by others, but that’s the goal. Dr. Thomas said they learned ways during the study to make the fully automated, online program easier for others to adopt.
Measuring any effect on weight loss at 1 year is the primary aim of the study. “I think we expect to find something similar to what we see in previous studies, which is that a certain amount of weight regain will be the norm” at 1 year, Dr. Thomas said.
“But a certain amount of weight loss and associated health benefits will persist, making it worthwhile even if, on average, some gradual regain occurs.”A version of this article first appeared on WebMD.com.
FROM OBESITY
More evidence that COVID-19 started in Wuhan marketplace
The original spread of the virus was a one-two punch, the studies found. Twice, the virus jumped from animals to humans. Virus genetics and outbreak modeling in one study revealed two strains released a few weeks apart in November and December 2019.
“Now I realize it sounds like I just said that a once-in-a-generation event happened twice in short succession, and pandemics are indeed rare,” Joel O. Wertheim, PhD, said at a briefing sponsored by the American Association for the Advancement of Science.
A unique storm of factors had to be present for the outbreak to blow up into a pandemic: Animals carrying a virus that could spread to humans, close human contact with these animals, and a city large enough for the infection to take off before it could be contained are examples.
Unluckily for us humans, this coronavirus – SARS-CoV-2 – is a “generalist virus” capable of infecting many animals, including humans.
“Once all the conditions are in place ... the barriers to spillover have been lowered,” said Dr. Wertheim, a researcher in genetic and molecular networks at the University of California, San Diego. In fact, beyond the two strains of the virus that took hold, there were likely up to two dozen more times where people got the virus but did not spread it far and wide, and it died out.
Overall, the odds were against the virus – 78% of the time, the “introduction” to humans was likely to go extinct, the study showed.
The research revealed the COVID-19 pandemic started small.
“Our model shows that there were likely only a few dozen infections, and only several hospitalizations due to COVID-19, by early December,” said Jonathan Pekar, a graduate student working with Dr. Wertheim.
In Wuhan in late 2019, Mr. Pekar said, there was not a single positive coronavirus sample from thousands of samples from healthy blood donors tested between September and December. Likewise, not one blood sample from patients hospitalized with flu-like illness from October to December 2019 tested positive for SARS-CoV-2.
Mapping the outbreak
A second study published in the journal Science mapped out the earliest COVID-19 cases. This effort showed a tight cluster around the wholesale seafood market inside Wuhan, a city of 11 million residents.
When researchers tried other scenarios – modeling outbreaks in other parts of the city – the pattern did not hold. Again, the Wuhan market appeared to be ground zero for the start of the pandemic.
Michael Worobey, PhD, and colleagues used data from Chinese scientists and the World Health Organization for the study.
“There was this extraordinary pattern where the highest density of cases was both extremely near to and very centered on this market,” said Dr. Worobey, head of ecology and evolutionary biology at the University of Arizona, Tucson.
The highest density of cases, in a city of 8,000 square kilometers, was a “very, very small area of about a third of a kilometer square,” he said.
The outbreak pattern showed the Wuhan market “smack dab in the middle.”
So if it started with infected workers at the market, how did it spread from there? It’s likely the virus got into the community as the vendors at the market went to local shops, infecting people in those stores. Then local community members not linked to the market started getting the virus, Dr. Worobey said.
The investigators also identified which stalls in the market were most likely involved, a sort of internal clustering. “That clustering is very, very specifically in the parts of the market where ... they were selling wildlife, including, for example, raccoon dogs and other animals that we know are susceptible to infection with SARS-CoV-2,” said Kristian Andersen, PhD, director of infectious disease genomics at the Scripps Research Institute in La Jolla, Calif.
What remains unknown is which animal or animals carried the virus, although the raccoon dog – an animal similar to a fox that is native to parts of Asia – remains central to most theories. In addition, many of the farms supplying animals to the market have since been closed, making it challenging for researchers to figure out exactly where infected animals came from.
“We don’t know necessarily, but raccoon dogs were sold at this market all the way up to the beginning of the pandemic,” Dr. Andersen said.
Not ruling out other theories
People who believe SARS-CoV-2 was released from a laboratory in China at first included Dr. Worobey himself. “I’ve in the past been much more open to the lab leak idea,” he said. “And published that in a letter in Science” in November 2021.
The letter was “much more influential than I thought it would be in ways that I think it turned out to be quite damaging,” he said. As more evidence emerged since then, Dr. Worobey said he came around to the Wuhan market source theory.
Dr. Andersen agreed he was more open to the lab-leak theory at first. “I was quite convinced of the lab leak myself until we dove into this very carefully and looked at it much closer,” he said. Newer evidence convinced him “that actually, the data points to this particular market.”
“Have we disproved the lab-leak theory? No,” Dr. Anderson said. “Will we ever be able to? No.” But the Wuhan market origin scenario is more plausible. “I would say these two papers combined present the strongest evidence of that to date.”
Identifying the source of the outbreak that led to the COVID-19 pandemic is based in science, Dr. Andersen said. “What we’re trying to understand is the origin of the pandemic. We’re not trying to place blame.”
Future directions
“With pandemics being pandemics, they affect all of us,” Dr. Andersen said. “We can’t prevent these kinds of events that led to the COVID-19 pandemic. But what we can hope to do is to prevent outbreaks from becoming pandemics.”
Rapid reporting of data and cooperation are needed going forward, Dr. Andersen said. Very strong surveillance systems, including wastewater surveillance, could help monitor for SARS-CoV-2, and other pathogens of potential concern in the future as well.
It should be standard practice for medical professionals to be on alert for unusual respiratory infections too, the researchers said.
“It’s a bloody lucky thing that the doctors at the Shinwa hospital were so on the ball, that they noticed that these cases were something unusual at the end of December,” Dr. Worobey said. “It didn’t have to work out that way.”
A version of this article first appeared on WebMD.com.
The original spread of the virus was a one-two punch, the studies found. Twice, the virus jumped from animals to humans. Virus genetics and outbreak modeling in one study revealed two strains released a few weeks apart in November and December 2019.
“Now I realize it sounds like I just said that a once-in-a-generation event happened twice in short succession, and pandemics are indeed rare,” Joel O. Wertheim, PhD, said at a briefing sponsored by the American Association for the Advancement of Science.
A unique storm of factors had to be present for the outbreak to blow up into a pandemic: Animals carrying a virus that could spread to humans, close human contact with these animals, and a city large enough for the infection to take off before it could be contained are examples.
Unluckily for us humans, this coronavirus – SARS-CoV-2 – is a “generalist virus” capable of infecting many animals, including humans.
“Once all the conditions are in place ... the barriers to spillover have been lowered,” said Dr. Wertheim, a researcher in genetic and molecular networks at the University of California, San Diego. In fact, beyond the two strains of the virus that took hold, there were likely up to two dozen more times where people got the virus but did not spread it far and wide, and it died out.
Overall, the odds were against the virus – 78% of the time, the “introduction” to humans was likely to go extinct, the study showed.
The research revealed the COVID-19 pandemic started small.
“Our model shows that there were likely only a few dozen infections, and only several hospitalizations due to COVID-19, by early December,” said Jonathan Pekar, a graduate student working with Dr. Wertheim.
In Wuhan in late 2019, Mr. Pekar said, there was not a single positive coronavirus sample from thousands of samples from healthy blood donors tested between September and December. Likewise, not one blood sample from patients hospitalized with flu-like illness from October to December 2019 tested positive for SARS-CoV-2.
Mapping the outbreak
A second study published in the journal Science mapped out the earliest COVID-19 cases. This effort showed a tight cluster around the wholesale seafood market inside Wuhan, a city of 11 million residents.
When researchers tried other scenarios – modeling outbreaks in other parts of the city – the pattern did not hold. Again, the Wuhan market appeared to be ground zero for the start of the pandemic.
Michael Worobey, PhD, and colleagues used data from Chinese scientists and the World Health Organization for the study.
“There was this extraordinary pattern where the highest density of cases was both extremely near to and very centered on this market,” said Dr. Worobey, head of ecology and evolutionary biology at the University of Arizona, Tucson.
The highest density of cases, in a city of 8,000 square kilometers, was a “very, very small area of about a third of a kilometer square,” he said.
The outbreak pattern showed the Wuhan market “smack dab in the middle.”
So if it started with infected workers at the market, how did it spread from there? It’s likely the virus got into the community as the vendors at the market went to local shops, infecting people in those stores. Then local community members not linked to the market started getting the virus, Dr. Worobey said.
The investigators also identified which stalls in the market were most likely involved, a sort of internal clustering. “That clustering is very, very specifically in the parts of the market where ... they were selling wildlife, including, for example, raccoon dogs and other animals that we know are susceptible to infection with SARS-CoV-2,” said Kristian Andersen, PhD, director of infectious disease genomics at the Scripps Research Institute in La Jolla, Calif.
What remains unknown is which animal or animals carried the virus, although the raccoon dog – an animal similar to a fox that is native to parts of Asia – remains central to most theories. In addition, many of the farms supplying animals to the market have since been closed, making it challenging for researchers to figure out exactly where infected animals came from.
“We don’t know necessarily, but raccoon dogs were sold at this market all the way up to the beginning of the pandemic,” Dr. Andersen said.
Not ruling out other theories
People who believe SARS-CoV-2 was released from a laboratory in China at first included Dr. Worobey himself. “I’ve in the past been much more open to the lab leak idea,” he said. “And published that in a letter in Science” in November 2021.
The letter was “much more influential than I thought it would be in ways that I think it turned out to be quite damaging,” he said. As more evidence emerged since then, Dr. Worobey said he came around to the Wuhan market source theory.
Dr. Andersen agreed he was more open to the lab-leak theory at first. “I was quite convinced of the lab leak myself until we dove into this very carefully and looked at it much closer,” he said. Newer evidence convinced him “that actually, the data points to this particular market.”
“Have we disproved the lab-leak theory? No,” Dr. Anderson said. “Will we ever be able to? No.” But the Wuhan market origin scenario is more plausible. “I would say these two papers combined present the strongest evidence of that to date.”
Identifying the source of the outbreak that led to the COVID-19 pandemic is based in science, Dr. Andersen said. “What we’re trying to understand is the origin of the pandemic. We’re not trying to place blame.”
Future directions
“With pandemics being pandemics, they affect all of us,” Dr. Andersen said. “We can’t prevent these kinds of events that led to the COVID-19 pandemic. But what we can hope to do is to prevent outbreaks from becoming pandemics.”
Rapid reporting of data and cooperation are needed going forward, Dr. Andersen said. Very strong surveillance systems, including wastewater surveillance, could help monitor for SARS-CoV-2, and other pathogens of potential concern in the future as well.
It should be standard practice for medical professionals to be on alert for unusual respiratory infections too, the researchers said.
“It’s a bloody lucky thing that the doctors at the Shinwa hospital were so on the ball, that they noticed that these cases were something unusual at the end of December,” Dr. Worobey said. “It didn’t have to work out that way.”
A version of this article first appeared on WebMD.com.
The original spread of the virus was a one-two punch, the studies found. Twice, the virus jumped from animals to humans. Virus genetics and outbreak modeling in one study revealed two strains released a few weeks apart in November and December 2019.
“Now I realize it sounds like I just said that a once-in-a-generation event happened twice in short succession, and pandemics are indeed rare,” Joel O. Wertheim, PhD, said at a briefing sponsored by the American Association for the Advancement of Science.
A unique storm of factors had to be present for the outbreak to blow up into a pandemic: Animals carrying a virus that could spread to humans, close human contact with these animals, and a city large enough for the infection to take off before it could be contained are examples.
Unluckily for us humans, this coronavirus – SARS-CoV-2 – is a “generalist virus” capable of infecting many animals, including humans.
“Once all the conditions are in place ... the barriers to spillover have been lowered,” said Dr. Wertheim, a researcher in genetic and molecular networks at the University of California, San Diego. In fact, beyond the two strains of the virus that took hold, there were likely up to two dozen more times where people got the virus but did not spread it far and wide, and it died out.
Overall, the odds were against the virus – 78% of the time, the “introduction” to humans was likely to go extinct, the study showed.
The research revealed the COVID-19 pandemic started small.
“Our model shows that there were likely only a few dozen infections, and only several hospitalizations due to COVID-19, by early December,” said Jonathan Pekar, a graduate student working with Dr. Wertheim.
In Wuhan in late 2019, Mr. Pekar said, there was not a single positive coronavirus sample from thousands of samples from healthy blood donors tested between September and December. Likewise, not one blood sample from patients hospitalized with flu-like illness from October to December 2019 tested positive for SARS-CoV-2.
Mapping the outbreak
A second study published in the journal Science mapped out the earliest COVID-19 cases. This effort showed a tight cluster around the wholesale seafood market inside Wuhan, a city of 11 million residents.
When researchers tried other scenarios – modeling outbreaks in other parts of the city – the pattern did not hold. Again, the Wuhan market appeared to be ground zero for the start of the pandemic.
Michael Worobey, PhD, and colleagues used data from Chinese scientists and the World Health Organization for the study.
“There was this extraordinary pattern where the highest density of cases was both extremely near to and very centered on this market,” said Dr. Worobey, head of ecology and evolutionary biology at the University of Arizona, Tucson.
The highest density of cases, in a city of 8,000 square kilometers, was a “very, very small area of about a third of a kilometer square,” he said.
The outbreak pattern showed the Wuhan market “smack dab in the middle.”
So if it started with infected workers at the market, how did it spread from there? It’s likely the virus got into the community as the vendors at the market went to local shops, infecting people in those stores. Then local community members not linked to the market started getting the virus, Dr. Worobey said.
The investigators also identified which stalls in the market were most likely involved, a sort of internal clustering. “That clustering is very, very specifically in the parts of the market where ... they were selling wildlife, including, for example, raccoon dogs and other animals that we know are susceptible to infection with SARS-CoV-2,” said Kristian Andersen, PhD, director of infectious disease genomics at the Scripps Research Institute in La Jolla, Calif.
What remains unknown is which animal or animals carried the virus, although the raccoon dog – an animal similar to a fox that is native to parts of Asia – remains central to most theories. In addition, many of the farms supplying animals to the market have since been closed, making it challenging for researchers to figure out exactly where infected animals came from.
“We don’t know necessarily, but raccoon dogs were sold at this market all the way up to the beginning of the pandemic,” Dr. Andersen said.
Not ruling out other theories
People who believe SARS-CoV-2 was released from a laboratory in China at first included Dr. Worobey himself. “I’ve in the past been much more open to the lab leak idea,” he said. “And published that in a letter in Science” in November 2021.
The letter was “much more influential than I thought it would be in ways that I think it turned out to be quite damaging,” he said. As more evidence emerged since then, Dr. Worobey said he came around to the Wuhan market source theory.
Dr. Andersen agreed he was more open to the lab-leak theory at first. “I was quite convinced of the lab leak myself until we dove into this very carefully and looked at it much closer,” he said. Newer evidence convinced him “that actually, the data points to this particular market.”
“Have we disproved the lab-leak theory? No,” Dr. Anderson said. “Will we ever be able to? No.” But the Wuhan market origin scenario is more plausible. “I would say these two papers combined present the strongest evidence of that to date.”
Identifying the source of the outbreak that led to the COVID-19 pandemic is based in science, Dr. Andersen said. “What we’re trying to understand is the origin of the pandemic. We’re not trying to place blame.”
Future directions
“With pandemics being pandemics, they affect all of us,” Dr. Andersen said. “We can’t prevent these kinds of events that led to the COVID-19 pandemic. But what we can hope to do is to prevent outbreaks from becoming pandemics.”
Rapid reporting of data and cooperation are needed going forward, Dr. Andersen said. Very strong surveillance systems, including wastewater surveillance, could help monitor for SARS-CoV-2, and other pathogens of potential concern in the future as well.
It should be standard practice for medical professionals to be on alert for unusual respiratory infections too, the researchers said.
“It’s a bloody lucky thing that the doctors at the Shinwa hospital were so on the ball, that they noticed that these cases were something unusual at the end of December,” Dr. Worobey said. “It didn’t have to work out that way.”
A version of this article first appeared on WebMD.com.
Neuroscientist alleges irregularities in Alzheimer’s research
A U.S. neuroscientist claims that some of the studies of the experimental agent, simufilam (Cassava Sciences), a drug that targets amyloid beta (Abeta) in Alzheimer’s disease (AD), are flawed, and, as a result, has taken his concerns to the National Institutes of Health.
Matthew Schrag, MD, PhD, department of neurology, Vanderbilt University Medical Center, Nashville, Tenn., uncovered what he calls inconsistencies in major studies examining the drug.
to support the hypothesis that buildup of amyloid in the brain causes AD. The NIH has funded research into Abeta as a potential cause of AD to the tune of millions of dollars for years.
“This hypothesis has been the central dominant thinking of the field,” Dr. Schrag told this news organization. “A lot of the therapies that have been developed and tested clinically over the last decade focused on the amyloid hypothesis in one formulation or another. So, it’s an important component of the way we think about Alzheimer’s disease,” he added.
In an in-depth article published in Science and written by investigative reporter Charles Piller, Dr. Schrag said he became involved after a colleague suggested he work with an attorney investigating simufilam. The lawyer paid Dr. Schrag $18,000 to investigate the research behind the agent. Cassava Sciences denies any misconduct, according to the article.
Dr. Schrag ran many AD studies through sophisticated imaging software. The effort revealed multiple Western blot images – which scientists use to detect the presence and amount of proteins in a sample – that appeared to be altered.
High stakes
Dr. Schrag found “apparently altered or duplicated images in dozens of journal articles,” the Science article states.
“A lot is at stake in terms of getting this right and it’s also important to acknowledge the limitations of what we can do. We were working with what’s published, what’s publicly available, and I think that it raises quite a lot of red flags, but we’ve also not reviewed the original material because it’s simply not available to us,” Dr. Schrag said in an interview.
However, he added that despite these limitations he believes “there’s enough here that it’s important for regulatory bodies to take a closer look at it to make sure that the data is right.”
Science reports that it launched its own independent review, asking several neuroscience experts to also review the research. They agreed with Dr. Schrag’s overall conclusions that something was amiss.
Many of the studies questioned in the whistleblower report involve Sylvain Lesné, PhD, who runs The Lesné Laboratory at the University of Minnesota, Minneapolis, and is an associate professor of neuroscience. His colleague Karen Ashe, MD, PhD, a professor of neurology at the same institution, was also mentioned in the whistleblower report. She was coauthor of a 2006 report in Nature that identified an Abeta subtype as a potential culprit behind AD.
This news organization reached out to Dr. Lesné and Dr. Ashe for comment, but has not received a response.
However, an email from a University of Minnesota spokesperson said the institution is “aware that questions have arisen regarding certain images used in peer-reviewed research publications authored by University faculty Dr. Ashe and Dr. Lesné. The University will follow its processes to review the questions any claims have raised. At this time, we have no further information to provide.”
A matter of trust
Dr. Schrag noted the “important trust relationship between patients, physicians and scientists. When we’re exploring diseases that we don’t have good treatments for.” He added that when patients agree to participate in trials and accept the associated risks, “we owe them a very high degree of integrity regarding the foundational data.”
Dr. Schrag also pointed out that there are limited resources to study these diseases. “There is some potential for that to be misdirected. It’s important for us to pay attention to data integrity issues, to make sure that we’re investing in the right places.”
The term “fraud” does not appear in Dr. Schrag’s whistleblower report, nor does he claim misconduct in the report. However, his work has spurred some independent, ongoing investigation into the claims by several journals that published the works in question, including Nature and Science Signaling.
Dr. Schrag said that if his findings are validated through an investigation he would like to see the scientific record corrected.
“Ultimately, I’d like to see a new set of hypotheses given a chance to look at this disease from a new perspective,” he added.
Dr. Schrag noted that the work described in the Science article was performed outside of his employment with Vanderbilt University Medical Center and that his opinions do not necessarily represent the views of Vanderbilt University or Vanderbilt University Medical Center.
A version of this article first appeared on Medscape.com.
A U.S. neuroscientist claims that some of the studies of the experimental agent, simufilam (Cassava Sciences), a drug that targets amyloid beta (Abeta) in Alzheimer’s disease (AD), are flawed, and, as a result, has taken his concerns to the National Institutes of Health.
Matthew Schrag, MD, PhD, department of neurology, Vanderbilt University Medical Center, Nashville, Tenn., uncovered what he calls inconsistencies in major studies examining the drug.
to support the hypothesis that buildup of amyloid in the brain causes AD. The NIH has funded research into Abeta as a potential cause of AD to the tune of millions of dollars for years.
“This hypothesis has been the central dominant thinking of the field,” Dr. Schrag told this news organization. “A lot of the therapies that have been developed and tested clinically over the last decade focused on the amyloid hypothesis in one formulation or another. So, it’s an important component of the way we think about Alzheimer’s disease,” he added.
In an in-depth article published in Science and written by investigative reporter Charles Piller, Dr. Schrag said he became involved after a colleague suggested he work with an attorney investigating simufilam. The lawyer paid Dr. Schrag $18,000 to investigate the research behind the agent. Cassava Sciences denies any misconduct, according to the article.
Dr. Schrag ran many AD studies through sophisticated imaging software. The effort revealed multiple Western blot images – which scientists use to detect the presence and amount of proteins in a sample – that appeared to be altered.
High stakes
Dr. Schrag found “apparently altered or duplicated images in dozens of journal articles,” the Science article states.
“A lot is at stake in terms of getting this right and it’s also important to acknowledge the limitations of what we can do. We were working with what’s published, what’s publicly available, and I think that it raises quite a lot of red flags, but we’ve also not reviewed the original material because it’s simply not available to us,” Dr. Schrag said in an interview.
However, he added that despite these limitations he believes “there’s enough here that it’s important for regulatory bodies to take a closer look at it to make sure that the data is right.”
Science reports that it launched its own independent review, asking several neuroscience experts to also review the research. They agreed with Dr. Schrag’s overall conclusions that something was amiss.
Many of the studies questioned in the whistleblower report involve Sylvain Lesné, PhD, who runs The Lesné Laboratory at the University of Minnesota, Minneapolis, and is an associate professor of neuroscience. His colleague Karen Ashe, MD, PhD, a professor of neurology at the same institution, was also mentioned in the whistleblower report. She was coauthor of a 2006 report in Nature that identified an Abeta subtype as a potential culprit behind AD.
This news organization reached out to Dr. Lesné and Dr. Ashe for comment, but has not received a response.
However, an email from a University of Minnesota spokesperson said the institution is “aware that questions have arisen regarding certain images used in peer-reviewed research publications authored by University faculty Dr. Ashe and Dr. Lesné. The University will follow its processes to review the questions any claims have raised. At this time, we have no further information to provide.”
A matter of trust
Dr. Schrag noted the “important trust relationship between patients, physicians and scientists. When we’re exploring diseases that we don’t have good treatments for.” He added that when patients agree to participate in trials and accept the associated risks, “we owe them a very high degree of integrity regarding the foundational data.”
Dr. Schrag also pointed out that there are limited resources to study these diseases. “There is some potential for that to be misdirected. It’s important for us to pay attention to data integrity issues, to make sure that we’re investing in the right places.”
The term “fraud” does not appear in Dr. Schrag’s whistleblower report, nor does he claim misconduct in the report. However, his work has spurred some independent, ongoing investigation into the claims by several journals that published the works in question, including Nature and Science Signaling.
Dr. Schrag said that if his findings are validated through an investigation he would like to see the scientific record corrected.
“Ultimately, I’d like to see a new set of hypotheses given a chance to look at this disease from a new perspective,” he added.
Dr. Schrag noted that the work described in the Science article was performed outside of his employment with Vanderbilt University Medical Center and that his opinions do not necessarily represent the views of Vanderbilt University or Vanderbilt University Medical Center.
A version of this article first appeared on Medscape.com.
A U.S. neuroscientist claims that some of the studies of the experimental agent, simufilam (Cassava Sciences), a drug that targets amyloid beta (Abeta) in Alzheimer’s disease (AD), are flawed, and, as a result, has taken his concerns to the National Institutes of Health.
Matthew Schrag, MD, PhD, department of neurology, Vanderbilt University Medical Center, Nashville, Tenn., uncovered what he calls inconsistencies in major studies examining the drug.
to support the hypothesis that buildup of amyloid in the brain causes AD. The NIH has funded research into Abeta as a potential cause of AD to the tune of millions of dollars for years.
“This hypothesis has been the central dominant thinking of the field,” Dr. Schrag told this news organization. “A lot of the therapies that have been developed and tested clinically over the last decade focused on the amyloid hypothesis in one formulation or another. So, it’s an important component of the way we think about Alzheimer’s disease,” he added.
In an in-depth article published in Science and written by investigative reporter Charles Piller, Dr. Schrag said he became involved after a colleague suggested he work with an attorney investigating simufilam. The lawyer paid Dr. Schrag $18,000 to investigate the research behind the agent. Cassava Sciences denies any misconduct, according to the article.
Dr. Schrag ran many AD studies through sophisticated imaging software. The effort revealed multiple Western blot images – which scientists use to detect the presence and amount of proteins in a sample – that appeared to be altered.
High stakes
Dr. Schrag found “apparently altered or duplicated images in dozens of journal articles,” the Science article states.
“A lot is at stake in terms of getting this right and it’s also important to acknowledge the limitations of what we can do. We were working with what’s published, what’s publicly available, and I think that it raises quite a lot of red flags, but we’ve also not reviewed the original material because it’s simply not available to us,” Dr. Schrag said in an interview.
However, he added that despite these limitations he believes “there’s enough here that it’s important for regulatory bodies to take a closer look at it to make sure that the data is right.”
Science reports that it launched its own independent review, asking several neuroscience experts to also review the research. They agreed with Dr. Schrag’s overall conclusions that something was amiss.
Many of the studies questioned in the whistleblower report involve Sylvain Lesné, PhD, who runs The Lesné Laboratory at the University of Minnesota, Minneapolis, and is an associate professor of neuroscience. His colleague Karen Ashe, MD, PhD, a professor of neurology at the same institution, was also mentioned in the whistleblower report. She was coauthor of a 2006 report in Nature that identified an Abeta subtype as a potential culprit behind AD.
This news organization reached out to Dr. Lesné and Dr. Ashe for comment, but has not received a response.
However, an email from a University of Minnesota spokesperson said the institution is “aware that questions have arisen regarding certain images used in peer-reviewed research publications authored by University faculty Dr. Ashe and Dr. Lesné. The University will follow its processes to review the questions any claims have raised. At this time, we have no further information to provide.”
A matter of trust
Dr. Schrag noted the “important trust relationship between patients, physicians and scientists. When we’re exploring diseases that we don’t have good treatments for.” He added that when patients agree to participate in trials and accept the associated risks, “we owe them a very high degree of integrity regarding the foundational data.”
Dr. Schrag also pointed out that there are limited resources to study these diseases. “There is some potential for that to be misdirected. It’s important for us to pay attention to data integrity issues, to make sure that we’re investing in the right places.”
The term “fraud” does not appear in Dr. Schrag’s whistleblower report, nor does he claim misconduct in the report. However, his work has spurred some independent, ongoing investigation into the claims by several journals that published the works in question, including Nature and Science Signaling.
Dr. Schrag said that if his findings are validated through an investigation he would like to see the scientific record corrected.
“Ultimately, I’d like to see a new set of hypotheses given a chance to look at this disease from a new perspective,” he added.
Dr. Schrag noted that the work described in the Science article was performed outside of his employment with Vanderbilt University Medical Center and that his opinions do not necessarily represent the views of Vanderbilt University or Vanderbilt University Medical Center.
A version of this article first appeared on Medscape.com.
At-home colorectal cancer testing and follow-up vary by ethnicity
Doctors were significantly less likely to order colorectal cancer screening with the at-home test Cologuard (Exact Sciences) for Black patients and were more likely to order the test for Asian patients, new evidence reveals.
Investigators retrospectively studied 557,156 patients in the Mayo Clinic health system from 2012 to 2022. They found that Cologuard was ordered for 8.7% of Black patients, compared to 11.9% of White patients and 13.1% of Asian patients.
Both minority groups were less likely than White patients to undergo a follow-up colonoscopy within 1 year of Cologuard testing. Cologuard tests the stool for blood and DNA markers associated with colorectal cancer.
Although the researchers did not examine the reasons driving the disparities, lead investigator Ahmed Ouni, MD, told this news organization that “it could be patient preferences ... or there could be some bias as providers ourselves in how we present the data to patients.”
Dr. Ouni presented the findings on May 22 at the annual Digestive Disease Week® (DDW), held in person in San Diego and virtually.
Breakdown by physician specialty
“We looked at the specialty of physicians ordering these because we wanted to see where the disparity was coming from, if there was a disparity,” said Dr. Ouni, a gastroenterologist at Mayo Clinic, Jacksonville, Florida.
Just over half (51%) of the patients received care from family medicine physicians, 27% received care from internists, and 22% were seen by gastroenterologists.
Family physicians ordered Cologuard testing for 8.7% of Black patients, compared with 16.1% of White patients, a significant difference (P < .001). Internists ordered the test for 10.5% of Black patients and 11.1% of White patients (P < .001). Gastroenterologists ordered Cologuard screening for 2.4% of Black patients and 3.2% of White patients (P = .009).
Gastroenterologists were 47% more likely to order Cologuard for Asian patients, and internists were 16% more likely to order it for this population than for White patients. However, the findings were not statistically significant for the overall cohort of Asian patients when the researchers adjusted for age and sex (P = 0.52).
Black patients were 25% less likely to have a follow-up colonoscopy within 1 year of undergoing a Cologuard test (odds ratio, 0.75; 95% confidence interval, 0.60-0.94), and Asian patients were 35% less likely (OR, 0.65; 95% CI, 0.52-0.82).
Ongoing and future research
Of the total study population, only 2.9% self-identified as Black; according to the 2020 U.S. Census, 12.4% of the population of the United States are Black persons.
When asked about the relatively low proportion of Black persons in the study, Dr. Ouni replied that the investigators are partnering with a Black physician group in the Jacksonville, Fla., area to expand the study to a more diverse population.
Additional plans include assessing how many positive Cologuard test results led to follow-up colonoscopies.
The investigators are also working with family physicians at the Mayo Clinic to examine how physicians explain colorectal cancer screening options to patients and are studying patient preferences regarding screening options, which include Cologuard, fecal immunochemical test (FIT)/fecal occult blood testing, CT colonography, and colonoscopy.
“We’re analyzing the data by ZIP code to see if this could be related to finances,” Dr. Ouni added. “So, if you’re Black or White and more financially impoverished, how does that affect how you view Cologuard and colorectal cancer screening?”
Some unanswered questions
“Overall this study supports other studies of a disparity in colorectal cancer screening for African Americans,” John M. Carethers, MD, told this news organization when asked to comment. “This is known for FIT and colonoscopy, and Cologuard, which is a genetic test in addition to FIT, appears to be in that same realm.”
“Noninvasive tests will have a role to reach populations who may not readily have access to colonoscopy,” said Dr. Carethers, John G. Searle Professor and chair of the department of internal medicine and professor of human genetics at the University of Michigan, Ann Arbor, and president of the American Gastroenterological Association. “The key here is if the test is positive, it needs to be followed up with a colonoscopy.”
Dr. Carethers added that the study raises some unanswered questions; for example, does the cost difference between testing options make a difference?
“FIT is under $20, but Cologuard is generally $300 or more,” he said. What percentage of the study population were offered other options, such as FIT? How does insurance status affect screening in different populations?”
“The findings should be taken in context of what other screening options were offered to or elected by patients,” agreed Gregory S. Cooper, MD, professor of medicine and population and quantitative health sciences at Case Western Reserve University and a gastroenterologist at University Hospitals Cleveland Medical Center.
According to guidelines, patients can be offered a menu of options, including FIT, colonoscopy, and Cologuard, Dr. Cooper said in an interview.
“If more African Americans elected colonoscopy, for example, the findings may balance out,” said Dr. Cooper, who was not affiliated with the study. “It would also be of interest to know if the racial differences changed over time. With the pandemic, the use of noninvasive options, such as Cologuard, have increased.”
“I will note that specifically for colonoscopy in the United States, the disparity gap had been closing from about 15% to 18% 20 years ago to about 3% in 2020 pre-COVID,” Dr. Carethers added. “I am fearful that COVID may have led to a widening of that gap again as we get more data.”
“It is important that noninvasive tests for screening be a part of the portfolio of offerings to patients, as about 35% of eligible at-risk persons who need to be screened are not screened in the United States,” Dr. Carethers said.
The study was not industry sponsored. Dr. Ouni and Dr. Carethers report no relevant financial relationships. Dr. Cooper has received consulting fees from Exact Sciences.
To help your patients understand their colorectal cancer screening options, send them to the AGA GI Patient Center.
A version of this article first appeared on Medscape.com.
Doctors were significantly less likely to order colorectal cancer screening with the at-home test Cologuard (Exact Sciences) for Black patients and were more likely to order the test for Asian patients, new evidence reveals.
Investigators retrospectively studied 557,156 patients in the Mayo Clinic health system from 2012 to 2022. They found that Cologuard was ordered for 8.7% of Black patients, compared to 11.9% of White patients and 13.1% of Asian patients.
Both minority groups were less likely than White patients to undergo a follow-up colonoscopy within 1 year of Cologuard testing. Cologuard tests the stool for blood and DNA markers associated with colorectal cancer.
Although the researchers did not examine the reasons driving the disparities, lead investigator Ahmed Ouni, MD, told this news organization that “it could be patient preferences ... or there could be some bias as providers ourselves in how we present the data to patients.”
Dr. Ouni presented the findings on May 22 at the annual Digestive Disease Week® (DDW), held in person in San Diego and virtually.
Breakdown by physician specialty
“We looked at the specialty of physicians ordering these because we wanted to see where the disparity was coming from, if there was a disparity,” said Dr. Ouni, a gastroenterologist at Mayo Clinic, Jacksonville, Florida.
Just over half (51%) of the patients received care from family medicine physicians, 27% received care from internists, and 22% were seen by gastroenterologists.
Family physicians ordered Cologuard testing for 8.7% of Black patients, compared with 16.1% of White patients, a significant difference (P < .001). Internists ordered the test for 10.5% of Black patients and 11.1% of White patients (P < .001). Gastroenterologists ordered Cologuard screening for 2.4% of Black patients and 3.2% of White patients (P = .009).
Gastroenterologists were 47% more likely to order Cologuard for Asian patients, and internists were 16% more likely to order it for this population than for White patients. However, the findings were not statistically significant for the overall cohort of Asian patients when the researchers adjusted for age and sex (P = 0.52).
Black patients were 25% less likely to have a follow-up colonoscopy within 1 year of undergoing a Cologuard test (odds ratio, 0.75; 95% confidence interval, 0.60-0.94), and Asian patients were 35% less likely (OR, 0.65; 95% CI, 0.52-0.82).
Ongoing and future research
Of the total study population, only 2.9% self-identified as Black; according to the 2020 U.S. Census, 12.4% of the population of the United States are Black persons.
When asked about the relatively low proportion of Black persons in the study, Dr. Ouni replied that the investigators are partnering with a Black physician group in the Jacksonville, Fla., area to expand the study to a more diverse population.
Additional plans include assessing how many positive Cologuard test results led to follow-up colonoscopies.
The investigators are also working with family physicians at the Mayo Clinic to examine how physicians explain colorectal cancer screening options to patients and are studying patient preferences regarding screening options, which include Cologuard, fecal immunochemical test (FIT)/fecal occult blood testing, CT colonography, and colonoscopy.
“We’re analyzing the data by ZIP code to see if this could be related to finances,” Dr. Ouni added. “So, if you’re Black or White and more financially impoverished, how does that affect how you view Cologuard and colorectal cancer screening?”
Some unanswered questions
“Overall this study supports other studies of a disparity in colorectal cancer screening for African Americans,” John M. Carethers, MD, told this news organization when asked to comment. “This is known for FIT and colonoscopy, and Cologuard, which is a genetic test in addition to FIT, appears to be in that same realm.”
“Noninvasive tests will have a role to reach populations who may not readily have access to colonoscopy,” said Dr. Carethers, John G. Searle Professor and chair of the department of internal medicine and professor of human genetics at the University of Michigan, Ann Arbor, and president of the American Gastroenterological Association. “The key here is if the test is positive, it needs to be followed up with a colonoscopy.”
Dr. Carethers added that the study raises some unanswered questions; for example, does the cost difference between testing options make a difference?
“FIT is under $20, but Cologuard is generally $300 or more,” he said. What percentage of the study population were offered other options, such as FIT? How does insurance status affect screening in different populations?”
“The findings should be taken in context of what other screening options were offered to or elected by patients,” agreed Gregory S. Cooper, MD, professor of medicine and population and quantitative health sciences at Case Western Reserve University and a gastroenterologist at University Hospitals Cleveland Medical Center.
According to guidelines, patients can be offered a menu of options, including FIT, colonoscopy, and Cologuard, Dr. Cooper said in an interview.
“If more African Americans elected colonoscopy, for example, the findings may balance out,” said Dr. Cooper, who was not affiliated with the study. “It would also be of interest to know if the racial differences changed over time. With the pandemic, the use of noninvasive options, such as Cologuard, have increased.”
“I will note that specifically for colonoscopy in the United States, the disparity gap had been closing from about 15% to 18% 20 years ago to about 3% in 2020 pre-COVID,” Dr. Carethers added. “I am fearful that COVID may have led to a widening of that gap again as we get more data.”
“It is important that noninvasive tests for screening be a part of the portfolio of offerings to patients, as about 35% of eligible at-risk persons who need to be screened are not screened in the United States,” Dr. Carethers said.
The study was not industry sponsored. Dr. Ouni and Dr. Carethers report no relevant financial relationships. Dr. Cooper has received consulting fees from Exact Sciences.
To help your patients understand their colorectal cancer screening options, send them to the AGA GI Patient Center.
A version of this article first appeared on Medscape.com.
Doctors were significantly less likely to order colorectal cancer screening with the at-home test Cologuard (Exact Sciences) for Black patients and were more likely to order the test for Asian patients, new evidence reveals.
Investigators retrospectively studied 557,156 patients in the Mayo Clinic health system from 2012 to 2022. They found that Cologuard was ordered for 8.7% of Black patients, compared to 11.9% of White patients and 13.1% of Asian patients.
Both minority groups were less likely than White patients to undergo a follow-up colonoscopy within 1 year of Cologuard testing. Cologuard tests the stool for blood and DNA markers associated with colorectal cancer.
Although the researchers did not examine the reasons driving the disparities, lead investigator Ahmed Ouni, MD, told this news organization that “it could be patient preferences ... or there could be some bias as providers ourselves in how we present the data to patients.”
Dr. Ouni presented the findings on May 22 at the annual Digestive Disease Week® (DDW), held in person in San Diego and virtually.
Breakdown by physician specialty
“We looked at the specialty of physicians ordering these because we wanted to see where the disparity was coming from, if there was a disparity,” said Dr. Ouni, a gastroenterologist at Mayo Clinic, Jacksonville, Florida.
Just over half (51%) of the patients received care from family medicine physicians, 27% received care from internists, and 22% were seen by gastroenterologists.
Family physicians ordered Cologuard testing for 8.7% of Black patients, compared with 16.1% of White patients, a significant difference (P < .001). Internists ordered the test for 10.5% of Black patients and 11.1% of White patients (P < .001). Gastroenterologists ordered Cologuard screening for 2.4% of Black patients and 3.2% of White patients (P = .009).
Gastroenterologists were 47% more likely to order Cologuard for Asian patients, and internists were 16% more likely to order it for this population than for White patients. However, the findings were not statistically significant for the overall cohort of Asian patients when the researchers adjusted for age and sex (P = 0.52).
Black patients were 25% less likely to have a follow-up colonoscopy within 1 year of undergoing a Cologuard test (odds ratio, 0.75; 95% confidence interval, 0.60-0.94), and Asian patients were 35% less likely (OR, 0.65; 95% CI, 0.52-0.82).
Ongoing and future research
Of the total study population, only 2.9% self-identified as Black; according to the 2020 U.S. Census, 12.4% of the population of the United States are Black persons.
When asked about the relatively low proportion of Black persons in the study, Dr. Ouni replied that the investigators are partnering with a Black physician group in the Jacksonville, Fla., area to expand the study to a more diverse population.
Additional plans include assessing how many positive Cologuard test results led to follow-up colonoscopies.
The investigators are also working with family physicians at the Mayo Clinic to examine how physicians explain colorectal cancer screening options to patients and are studying patient preferences regarding screening options, which include Cologuard, fecal immunochemical test (FIT)/fecal occult blood testing, CT colonography, and colonoscopy.
“We’re analyzing the data by ZIP code to see if this could be related to finances,” Dr. Ouni added. “So, if you’re Black or White and more financially impoverished, how does that affect how you view Cologuard and colorectal cancer screening?”
Some unanswered questions
“Overall this study supports other studies of a disparity in colorectal cancer screening for African Americans,” John M. Carethers, MD, told this news organization when asked to comment. “This is known for FIT and colonoscopy, and Cologuard, which is a genetic test in addition to FIT, appears to be in that same realm.”
“Noninvasive tests will have a role to reach populations who may not readily have access to colonoscopy,” said Dr. Carethers, John G. Searle Professor and chair of the department of internal medicine and professor of human genetics at the University of Michigan, Ann Arbor, and president of the American Gastroenterological Association. “The key here is if the test is positive, it needs to be followed up with a colonoscopy.”
Dr. Carethers added that the study raises some unanswered questions; for example, does the cost difference between testing options make a difference?
“FIT is under $20, but Cologuard is generally $300 or more,” he said. What percentage of the study population were offered other options, such as FIT? How does insurance status affect screening in different populations?”
“The findings should be taken in context of what other screening options were offered to or elected by patients,” agreed Gregory S. Cooper, MD, professor of medicine and population and quantitative health sciences at Case Western Reserve University and a gastroenterologist at University Hospitals Cleveland Medical Center.
According to guidelines, patients can be offered a menu of options, including FIT, colonoscopy, and Cologuard, Dr. Cooper said in an interview.
“If more African Americans elected colonoscopy, for example, the findings may balance out,” said Dr. Cooper, who was not affiliated with the study. “It would also be of interest to know if the racial differences changed over time. With the pandemic, the use of noninvasive options, such as Cologuard, have increased.”
“I will note that specifically for colonoscopy in the United States, the disparity gap had been closing from about 15% to 18% 20 years ago to about 3% in 2020 pre-COVID,” Dr. Carethers added. “I am fearful that COVID may have led to a widening of that gap again as we get more data.”
“It is important that noninvasive tests for screening be a part of the portfolio of offerings to patients, as about 35% of eligible at-risk persons who need to be screened are not screened in the United States,” Dr. Carethers said.
The study was not industry sponsored. Dr. Ouni and Dr. Carethers report no relevant financial relationships. Dr. Cooper has received consulting fees from Exact Sciences.
To help your patients understand their colorectal cancer screening options, send them to the AGA GI Patient Center.
A version of this article first appeared on Medscape.com.