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Medicare 2024 base rate cut triggers calls for pay overhaul
Physicians in 2024 can expect a 3.4% drop in the conversion factor that determines their base Medicare pay, according to federal officials, but they also will receive more money for primary care and treating complex conditions.
The Centers for Medicare & Medicaid Services on Nov. 2 released its 2024 final physician fee schedule, triggering renewed concerns from doctors’ groups, who protested CMS’ cuts when they were first previewed earlier in 2023.
The 2024 conversion factor, or base rate for clinician pay, will be $32.74, a decrease of $1.15, or 3.4%, from 2023’s level. The pay cuts come as costs of providing health care are expected to rise as much as 4.6% in 2024, the American Medical Association said.
The new rule follows a 2% payment reduction in 2023, AMA president Jesse M. Ehrenfeld, MD, MPH, said in a statement.
“This is a recipe for financial instability,” Dr. Ehrenfeld said. “Patients and physicians will wonder why such thin gruel is being served.”
The AMA is among the many physician groups pressing Congress to change its approach to paying clinicians and consider inflation rates in determining future payments.
Medicare already includes automatic inflation adjusters in other payment rules, such as the ones for care provided in hospitals. But Congress in 2015 eliminated this feature for the physician fee schedule when it passed the Medicare Access and CHIP Reauthorization Act.
A pending House bill, the bipartisan Strengthening Medicare for Patients and Providers Act (H.R.2474), would return to permanently including a broader inflation adjuster in the Medicare physician fee schedule.
“This long-overdue change would not only help provide greater stability within the Medicare payment system, but it would also help physicians’ practices – many of whom operate as small business owners – more effectively navigate the ever-changing economic factors that impact their practices, including rising medical costs, workforce and labor challenges, administrative burdens, office rental prices and more,” Larry Bucshon, MD (R-Ind.), Ami Bera, MD (D-Calif.), Raul Ruiz, MD (D-Calif.), and Mariannette Miller-Meeks, MD (R-Iowa), wrote in an opinion article in the newspaper The Hill.
Major changes to determining Medicare physician pay remain unlikely in 2023. Still, Congress has softened or blocked slated cuts in physician pay in recent years, passing temporary “doc fixes” as add-ons to spending packages.
E/M add-on payment
“We’re encouraged to see that CMS listened to our concerns and extended telehealth flexibilities as well as implemented the G2211 code, which will help Medicare beneficiaries and their physicians better manage complex and chronic rheumatic diseases,” said Douglas White, MD, PhD, president of the ACR.
A version of this article first appeared on Medscape.com.
Physicians in 2024 can expect a 3.4% drop in the conversion factor that determines their base Medicare pay, according to federal officials, but they also will receive more money for primary care and treating complex conditions.
The Centers for Medicare & Medicaid Services on Nov. 2 released its 2024 final physician fee schedule, triggering renewed concerns from doctors’ groups, who protested CMS’ cuts when they were first previewed earlier in 2023.
The 2024 conversion factor, or base rate for clinician pay, will be $32.74, a decrease of $1.15, or 3.4%, from 2023’s level. The pay cuts come as costs of providing health care are expected to rise as much as 4.6% in 2024, the American Medical Association said.
The new rule follows a 2% payment reduction in 2023, AMA president Jesse M. Ehrenfeld, MD, MPH, said in a statement.
“This is a recipe for financial instability,” Dr. Ehrenfeld said. “Patients and physicians will wonder why such thin gruel is being served.”
The AMA is among the many physician groups pressing Congress to change its approach to paying clinicians and consider inflation rates in determining future payments.
Medicare already includes automatic inflation adjusters in other payment rules, such as the ones for care provided in hospitals. But Congress in 2015 eliminated this feature for the physician fee schedule when it passed the Medicare Access and CHIP Reauthorization Act.
A pending House bill, the bipartisan Strengthening Medicare for Patients and Providers Act (H.R.2474), would return to permanently including a broader inflation adjuster in the Medicare physician fee schedule.
“This long-overdue change would not only help provide greater stability within the Medicare payment system, but it would also help physicians’ practices – many of whom operate as small business owners – more effectively navigate the ever-changing economic factors that impact their practices, including rising medical costs, workforce and labor challenges, administrative burdens, office rental prices and more,” Larry Bucshon, MD (R-Ind.), Ami Bera, MD (D-Calif.), Raul Ruiz, MD (D-Calif.), and Mariannette Miller-Meeks, MD (R-Iowa), wrote in an opinion article in the newspaper The Hill.
Major changes to determining Medicare physician pay remain unlikely in 2023. Still, Congress has softened or blocked slated cuts in physician pay in recent years, passing temporary “doc fixes” as add-ons to spending packages.
E/M add-on payment
“We’re encouraged to see that CMS listened to our concerns and extended telehealth flexibilities as well as implemented the G2211 code, which will help Medicare beneficiaries and their physicians better manage complex and chronic rheumatic diseases,” said Douglas White, MD, PhD, president of the ACR.
A version of this article first appeared on Medscape.com.
Physicians in 2024 can expect a 3.4% drop in the conversion factor that determines their base Medicare pay, according to federal officials, but they also will receive more money for primary care and treating complex conditions.
The Centers for Medicare & Medicaid Services on Nov. 2 released its 2024 final physician fee schedule, triggering renewed concerns from doctors’ groups, who protested CMS’ cuts when they were first previewed earlier in 2023.
The 2024 conversion factor, or base rate for clinician pay, will be $32.74, a decrease of $1.15, or 3.4%, from 2023’s level. The pay cuts come as costs of providing health care are expected to rise as much as 4.6% in 2024, the American Medical Association said.
The new rule follows a 2% payment reduction in 2023, AMA president Jesse M. Ehrenfeld, MD, MPH, said in a statement.
“This is a recipe for financial instability,” Dr. Ehrenfeld said. “Patients and physicians will wonder why such thin gruel is being served.”
The AMA is among the many physician groups pressing Congress to change its approach to paying clinicians and consider inflation rates in determining future payments.
Medicare already includes automatic inflation adjusters in other payment rules, such as the ones for care provided in hospitals. But Congress in 2015 eliminated this feature for the physician fee schedule when it passed the Medicare Access and CHIP Reauthorization Act.
A pending House bill, the bipartisan Strengthening Medicare for Patients and Providers Act (H.R.2474), would return to permanently including a broader inflation adjuster in the Medicare physician fee schedule.
“This long-overdue change would not only help provide greater stability within the Medicare payment system, but it would also help physicians’ practices – many of whom operate as small business owners – more effectively navigate the ever-changing economic factors that impact their practices, including rising medical costs, workforce and labor challenges, administrative burdens, office rental prices and more,” Larry Bucshon, MD (R-Ind.), Ami Bera, MD (D-Calif.), Raul Ruiz, MD (D-Calif.), and Mariannette Miller-Meeks, MD (R-Iowa), wrote in an opinion article in the newspaper The Hill.
Major changes to determining Medicare physician pay remain unlikely in 2023. Still, Congress has softened or blocked slated cuts in physician pay in recent years, passing temporary “doc fixes” as add-ons to spending packages.
E/M add-on payment
“We’re encouraged to see that CMS listened to our concerns and extended telehealth flexibilities as well as implemented the G2211 code, which will help Medicare beneficiaries and their physicians better manage complex and chronic rheumatic diseases,” said Douglas White, MD, PhD, president of the ACR.
A version of this article first appeared on Medscape.com.
RSV more common in IBD
A study presented this week in Vancouver at the ACG: American College of Gastroenterology annual meeting suggests that
RSV has historically been recognized in young and elderly populations and in patients who have received organ transplants. In fact, there is a body of literature that highlights the morbidity and mortality impact on immunocompromised organ transplant patients, but there is little research on the impact of RSV on patients with IBD.
For patients with inflammatory bowel disease (IBD), particularly those with comorbidities, an RSV infection can turn serious, said Ryan Smith, MD, a gastroenterology and hepatology fellow with the University of Wisconsin–Madison, who presented the study at the meeting.
“These patients are known to be at increased risk for infections, especially respiratory infections, with diseases such as influenza, pneumococcal pneumonia, and PJP (pneumocystis jirovecii pneumonia) being big risks,” he said during his presentation.
The Smith et al. study was a retrospective cohort study using data from the global TriNetX research network. It included an IBD cohort of 206,475 patients and a control cohort of 4.2 million patients without IBD.
Researchers found higher rates of RSV diagnoses in IBD cohorts across age groups (P <.0001 for all groups), but also when comorbidities were present. Patients with IBD who were being treated with immunomodulators or anti-TNF therapy were at increased risk for infection, but not just any infection – serious infections, Dr. Smith said.
“This risk [in general] seems to exist across all age groups from our youngest to our elderly populations And, this risk increases for our patients with underlying comorbidities in our inflammatory bowel disease group,” he said.
Among patients 18 and younger, 0.36% of the IBD cohort were at increased risk of RSV infection, compared with 0.16% of the control group. Among those 18-49 years old, the risk was 0.26% of the IBD cohort and 0.15% of the control group. Among patients older than 65 years, the risk was 0.55% for patients with IBD, compared with 0.24% of the control group.
In terms of hospitalizations, 47.3% of the patients 18 years old and younger were hospitalized, compared with 39.7% of the control group. For those 65 years and older, 56.4% of the IBD cohort were hospitalized, compared with 47.3% of the control group. The mortality rate in the IBD cohort was 4.7%.
New RSV vaccines approved this year
RSV is relatively common in the United States and accounts for approximately 1.4 million outpatient visits each year, but health care officials are concerned that number will rise this year as the 2023-2024 RSV season gets underway. In September, the Centers for Disease Control and Prevention issued a statement saying there has already been an increase in RSV activity in the southeastern part of the United States.
In May, the Food and Drug Administration approved Arexvy (GSK) for the prevention of RSV-related lower respiratory tract disease for use in adults ages 60 years and older. Also approved in May was Abrysvo (Pfizer) for pregnant women to prevent RSV-related lower respiratory tract disease (LRTD) and severe LRTD in infants from birth through 6 months of age.
The Centers for Disease Control and Prevention recommends that adults 60 years or older receive a single dose of RSV vaccine “using shared clinical decision-making and prioritizing those at highest risk for severe disease.” It also recommendeds a new immunization starting this fall to help protect all infants under 8 months and babies between 8 and 19 months who are at increased risk of severe RSV disease.
Patients who are eligible for the RSV vaccination should get it, said Freddy Caldera, DO, a physician-scientist in gastroenterology and hepatology at the University of Wisconsin–Madison and lead author of the IBD study presented at ACG. The study is intended to help clinicians who treat patients with IBD address questions from patients about the recently introduced RSV vaccines.
At this point, Dr. Caldera said, there is not enough evidence to say all adults with IBD should get RSV vaccinations. More work needs to be done to address this question, such as a replication of the findings of the work presented at ACG, he said. And in many cases too, insurers may not cover the RSV vaccine. In regards to other patients, the data presented at ACG can be part of a larger conversation between clinicians and patients.
Fielding questions from patients
In an interview, Jessica Philpott, MD, PhD, a gastroenterologist at Cleveland Clinic, described the study findings as an important attempt to understand the risk for RSV among patients with IBD.
Dr. Philpott said she is already getting questions from her patients about RSV vaccinations. Many patients with IBD are immunocompromised and thus have been interested in following up after learning about the new RSV vaccinations, especially after seeing news reports about rising cases, she said. “Certainly, every week I receive messages about the RSV vaccine” from patients, she said.
Dr. Philpott also said it’s too early to make blanket recommendations about RSV vaccinations for adults with IBS, as it is going to take some time to understand how these products work for these patients, she said.
But people with IBD know they already may be at high risk and will factor that in as they weigh whether to seek RSV vaccination, especially given its low risk for side effects, Dr. Philpott said. Patients with IBD who would not have insurance coverage for the vaccine may consider taking it anyway, she said.
“We would advocate to get this covered by their insurance because we have this data that shows they’re at greater risks than the average population,” she said.
This study received no outside funding. Dr. Smith indicated no relevant financial relationships. Dr. Caldera has served as a consultant for GlaxoSmithKline. Francis Farraye has served on a GSK advisory committee.
A study presented this week in Vancouver at the ACG: American College of Gastroenterology annual meeting suggests that
RSV has historically been recognized in young and elderly populations and in patients who have received organ transplants. In fact, there is a body of literature that highlights the morbidity and mortality impact on immunocompromised organ transplant patients, but there is little research on the impact of RSV on patients with IBD.
For patients with inflammatory bowel disease (IBD), particularly those with comorbidities, an RSV infection can turn serious, said Ryan Smith, MD, a gastroenterology and hepatology fellow with the University of Wisconsin–Madison, who presented the study at the meeting.
“These patients are known to be at increased risk for infections, especially respiratory infections, with diseases such as influenza, pneumococcal pneumonia, and PJP (pneumocystis jirovecii pneumonia) being big risks,” he said during his presentation.
The Smith et al. study was a retrospective cohort study using data from the global TriNetX research network. It included an IBD cohort of 206,475 patients and a control cohort of 4.2 million patients without IBD.
Researchers found higher rates of RSV diagnoses in IBD cohorts across age groups (P <.0001 for all groups), but also when comorbidities were present. Patients with IBD who were being treated with immunomodulators or anti-TNF therapy were at increased risk for infection, but not just any infection – serious infections, Dr. Smith said.
“This risk [in general] seems to exist across all age groups from our youngest to our elderly populations And, this risk increases for our patients with underlying comorbidities in our inflammatory bowel disease group,” he said.
Among patients 18 and younger, 0.36% of the IBD cohort were at increased risk of RSV infection, compared with 0.16% of the control group. Among those 18-49 years old, the risk was 0.26% of the IBD cohort and 0.15% of the control group. Among patients older than 65 years, the risk was 0.55% for patients with IBD, compared with 0.24% of the control group.
In terms of hospitalizations, 47.3% of the patients 18 years old and younger were hospitalized, compared with 39.7% of the control group. For those 65 years and older, 56.4% of the IBD cohort were hospitalized, compared with 47.3% of the control group. The mortality rate in the IBD cohort was 4.7%.
New RSV vaccines approved this year
RSV is relatively common in the United States and accounts for approximately 1.4 million outpatient visits each year, but health care officials are concerned that number will rise this year as the 2023-2024 RSV season gets underway. In September, the Centers for Disease Control and Prevention issued a statement saying there has already been an increase in RSV activity in the southeastern part of the United States.
In May, the Food and Drug Administration approved Arexvy (GSK) for the prevention of RSV-related lower respiratory tract disease for use in adults ages 60 years and older. Also approved in May was Abrysvo (Pfizer) for pregnant women to prevent RSV-related lower respiratory tract disease (LRTD) and severe LRTD in infants from birth through 6 months of age.
The Centers for Disease Control and Prevention recommends that adults 60 years or older receive a single dose of RSV vaccine “using shared clinical decision-making and prioritizing those at highest risk for severe disease.” It also recommendeds a new immunization starting this fall to help protect all infants under 8 months and babies between 8 and 19 months who are at increased risk of severe RSV disease.
Patients who are eligible for the RSV vaccination should get it, said Freddy Caldera, DO, a physician-scientist in gastroenterology and hepatology at the University of Wisconsin–Madison and lead author of the IBD study presented at ACG. The study is intended to help clinicians who treat patients with IBD address questions from patients about the recently introduced RSV vaccines.
At this point, Dr. Caldera said, there is not enough evidence to say all adults with IBD should get RSV vaccinations. More work needs to be done to address this question, such as a replication of the findings of the work presented at ACG, he said. And in many cases too, insurers may not cover the RSV vaccine. In regards to other patients, the data presented at ACG can be part of a larger conversation between clinicians and patients.
Fielding questions from patients
In an interview, Jessica Philpott, MD, PhD, a gastroenterologist at Cleveland Clinic, described the study findings as an important attempt to understand the risk for RSV among patients with IBD.
Dr. Philpott said she is already getting questions from her patients about RSV vaccinations. Many patients with IBD are immunocompromised and thus have been interested in following up after learning about the new RSV vaccinations, especially after seeing news reports about rising cases, she said. “Certainly, every week I receive messages about the RSV vaccine” from patients, she said.
Dr. Philpott also said it’s too early to make blanket recommendations about RSV vaccinations for adults with IBS, as it is going to take some time to understand how these products work for these patients, she said.
But people with IBD know they already may be at high risk and will factor that in as they weigh whether to seek RSV vaccination, especially given its low risk for side effects, Dr. Philpott said. Patients with IBD who would not have insurance coverage for the vaccine may consider taking it anyway, she said.
“We would advocate to get this covered by their insurance because we have this data that shows they’re at greater risks than the average population,” she said.
This study received no outside funding. Dr. Smith indicated no relevant financial relationships. Dr. Caldera has served as a consultant for GlaxoSmithKline. Francis Farraye has served on a GSK advisory committee.
A study presented this week in Vancouver at the ACG: American College of Gastroenterology annual meeting suggests that
RSV has historically been recognized in young and elderly populations and in patients who have received organ transplants. In fact, there is a body of literature that highlights the morbidity and mortality impact on immunocompromised organ transplant patients, but there is little research on the impact of RSV on patients with IBD.
For patients with inflammatory bowel disease (IBD), particularly those with comorbidities, an RSV infection can turn serious, said Ryan Smith, MD, a gastroenterology and hepatology fellow with the University of Wisconsin–Madison, who presented the study at the meeting.
“These patients are known to be at increased risk for infections, especially respiratory infections, with diseases such as influenza, pneumococcal pneumonia, and PJP (pneumocystis jirovecii pneumonia) being big risks,” he said during his presentation.
The Smith et al. study was a retrospective cohort study using data from the global TriNetX research network. It included an IBD cohort of 206,475 patients and a control cohort of 4.2 million patients without IBD.
Researchers found higher rates of RSV diagnoses in IBD cohorts across age groups (P <.0001 for all groups), but also when comorbidities were present. Patients with IBD who were being treated with immunomodulators or anti-TNF therapy were at increased risk for infection, but not just any infection – serious infections, Dr. Smith said.
“This risk [in general] seems to exist across all age groups from our youngest to our elderly populations And, this risk increases for our patients with underlying comorbidities in our inflammatory bowel disease group,” he said.
Among patients 18 and younger, 0.36% of the IBD cohort were at increased risk of RSV infection, compared with 0.16% of the control group. Among those 18-49 years old, the risk was 0.26% of the IBD cohort and 0.15% of the control group. Among patients older than 65 years, the risk was 0.55% for patients with IBD, compared with 0.24% of the control group.
In terms of hospitalizations, 47.3% of the patients 18 years old and younger were hospitalized, compared with 39.7% of the control group. For those 65 years and older, 56.4% of the IBD cohort were hospitalized, compared with 47.3% of the control group. The mortality rate in the IBD cohort was 4.7%.
New RSV vaccines approved this year
RSV is relatively common in the United States and accounts for approximately 1.4 million outpatient visits each year, but health care officials are concerned that number will rise this year as the 2023-2024 RSV season gets underway. In September, the Centers for Disease Control and Prevention issued a statement saying there has already been an increase in RSV activity in the southeastern part of the United States.
In May, the Food and Drug Administration approved Arexvy (GSK) for the prevention of RSV-related lower respiratory tract disease for use in adults ages 60 years and older. Also approved in May was Abrysvo (Pfizer) for pregnant women to prevent RSV-related lower respiratory tract disease (LRTD) and severe LRTD in infants from birth through 6 months of age.
The Centers for Disease Control and Prevention recommends that adults 60 years or older receive a single dose of RSV vaccine “using shared clinical decision-making and prioritizing those at highest risk for severe disease.” It also recommendeds a new immunization starting this fall to help protect all infants under 8 months and babies between 8 and 19 months who are at increased risk of severe RSV disease.
Patients who are eligible for the RSV vaccination should get it, said Freddy Caldera, DO, a physician-scientist in gastroenterology and hepatology at the University of Wisconsin–Madison and lead author of the IBD study presented at ACG. The study is intended to help clinicians who treat patients with IBD address questions from patients about the recently introduced RSV vaccines.
At this point, Dr. Caldera said, there is not enough evidence to say all adults with IBD should get RSV vaccinations. More work needs to be done to address this question, such as a replication of the findings of the work presented at ACG, he said. And in many cases too, insurers may not cover the RSV vaccine. In regards to other patients, the data presented at ACG can be part of a larger conversation between clinicians and patients.
Fielding questions from patients
In an interview, Jessica Philpott, MD, PhD, a gastroenterologist at Cleveland Clinic, described the study findings as an important attempt to understand the risk for RSV among patients with IBD.
Dr. Philpott said she is already getting questions from her patients about RSV vaccinations. Many patients with IBD are immunocompromised and thus have been interested in following up after learning about the new RSV vaccinations, especially after seeing news reports about rising cases, she said. “Certainly, every week I receive messages about the RSV vaccine” from patients, she said.
Dr. Philpott also said it’s too early to make blanket recommendations about RSV vaccinations for adults with IBS, as it is going to take some time to understand how these products work for these patients, she said.
But people with IBD know they already may be at high risk and will factor that in as they weigh whether to seek RSV vaccination, especially given its low risk for side effects, Dr. Philpott said. Patients with IBD who would not have insurance coverage for the vaccine may consider taking it anyway, she said.
“We would advocate to get this covered by their insurance because we have this data that shows they’re at greater risks than the average population,” she said.
This study received no outside funding. Dr. Smith indicated no relevant financial relationships. Dr. Caldera has served as a consultant for GlaxoSmithKline. Francis Farraye has served on a GSK advisory committee.
FROM ACG 2023
New study ties ultra-processed foods to IBD
, suggesting another field for inquiry about the potential role of industrial-produced edible food products in IBD.
The study, which was a meta-analysis of four studies, found a 47% greater risk of IBD in adults who consumed high levels of ultra-processed foods, compared with adults in reference groups.
“Our data are also consistent with other observational studies that found increased consumption of junk food, along with reduced intakes of fresh fruit and vegetables, are associated with the development of IBD. Because Americans consume over 60% of their calories in the form of ultra-processed foods, reductions in this level of consumption could meaningfully decrease the incidence of IBD,” wrote authors who were led by Eric Hecht, MD, PhD, MPH, president and executive director of the nonprofit Institute of Etiological Research, Boca Raton, Fla.
The potential effect of poor diet on the gut is a critical public health question, he said. Diet may be just one possible contributor to inflammatory bowel disease. Other contributors include genetics and having a compromised immune system.
Dr. Hecht and colleagues began this study with a search on the PubMed database of published research on IBD that included details of diet. Of 10 relevant studies, 4 studies met the inclusion criteria for the analysis.
The four studies included 652,880 adults, 2,240 cases of IBD with a follow-up period ranging from 2.3 to 22.3 years. Statistically significant elevated risks for both Crohn’s disease and ulcerative colitis were documented in the studies. There was a relative risk of 1.47 (95% confidence interval, 1.29-1.66) for IBD; 1.94 (95% CI, 1.45-2.58) for Crohn’s disease, and 1.26 (95% CI, 1.10-1.45) for ulcerative colitis.
Findings from the 4 studies
Chen et al. reported, in the Journal of Crohn’s and Colitis, the results of a cross-sectional and prospective cohort study of 187,854 adults who were followed for an average of 10 years. They found that a higher intake of ultra-processed foods was associated with a higher incidence of Crohn’s disease but not ulcerative colitis. It also found that people who were already diagnosed with an IBD consumed more ultra-processed foods than did those without a diagnosis. The authors called for further studies to address the impact of UPF intake.
Vasseur et al. documented, in Inflammatory Bowel Diseases, research drawn from the NutriNet-Santé Study, a large French web-based prospective study. It did not find that ultra-processed foods were significantly associated with the risk of incident IBD. But the authors noted that certain types of food items or dietary patterns could partly explain the increase in the incidence of IBD observed in several countries, saying that further large-scale studies would be needed to support pathophysiological assumptions made about the dietary risk factors and IBD.
In September 2020 in Gastroenterology, Lo et al. used data from the Nurses’ Health Study (1984-2014), Nurses’ Health Study II (1991-2015), and Health Professionals Follow-up Study (1986-2012). The authors reported finding dietary patterns associated with high inflammatory potential to be associated with increased risk of Crohn’s disease but not ulcerative colitis.
In October 2021 in Gastroenterology, Narula et al. reported finding no significant association between certain dietary patterns and risk of ulcerative colitis. There was some signal for Crohn’s disease, in keeping with findings from earlier research. Longer term follow-up is needed to clarify whether the observed excess risk for Crohn’s disease becomes more evident as more cases accumulate.
However, in an email interview with GI & Hepatology News, Neeraj Narula, MD, MPH, of McMaster University, Hamilton, Ont., cited two of his other published works that did make a connection between diet and IBD. In July 2021 in BMJ, he and colleagues reported findings of a prospective cohort study that found that higher intake of ultra-processed food was positively associated with risk of IBD. Further studies are needed to identify the contributory factors within ultra-processed foods, they wrote. He and colleagues published a meta-analysis of 5 cohort studies which concluded that higher ultra-processed food and lower unprocessed/minimally processed food intakes were associated with higher risk of Crohn’s disease but not ulcerative colitis.
Study limitations
Aviva Musicus, ScD, the science director for the nonprofit Center for Science in the Public Interest (CSPI), said the Dr. Hecht et al. meta-analysis suggests there could be a signal in the association between higher ultra-processed food consumption and IBD, but there’s also a lot of “noise” in this presentation.
It’s not clear from these analyses presented what might be driving the relationship between IBD and ultra-processed food, she said. “Is it the nutrient content of these foods, given that many are high in added sugar, sodium, and saturated fat and low in dietary fiber (potential risk factors for IBD)? Is it the emulsifiers used in some of these foods, or other chemicals added during processing? Or, is it something else?” Dr. Musicus said.
She said further studies are needed on the issue of ultra-processed food and IBD.
“I wasn’t convinced by the conclusion of this research abstract. It’s not clear to me that general reductions in UPF (ultra-processed foods) consumption could meaningfully decrease the incidence of IBD, given that it may be a subset of these (somewhat heterogeneous) foods driving the associations, and people may not reduce their consumption of that specific subset upon hearing this news,” Dr. Musicus said.
“However, we already know that consumers can reduce chronic disease risk by eating more vegetables, fruits, whole grains, and legumes (good sources of dietary fiber) and limiting consumption of added sugars, sodium, and saturated fat,” she added.
Miguel Regueiro, MD, chair of the Digestive Disease and Surgery Institute at Cleveland Clinic, agreed with the need for further study. There are limitations with the methodology used in the research from Dr. Hecht and colleagues, he said.
“Meta-analyses aren’t perfect and I think we all acknowledge that,” he said, adding that the Hecht poster provides “a larger perspective on the topic.”
There’s widespread agreement that ultraprocessed foods are not healthy, raising heart and cancer risks, he said. In counseling his patients, Dr. Regueiro said he acknowledges the challenges many people face in trying to pursue a healthier diet. Ultraprocessed foods tend to be cheap and readily available, and many people need help in spotting them, such as learning to look at labels for unfamiliar terms.
“What I tell my own patients in the clinic is to really try to clean up the diet as much as possible and in a realistic way,” he said.
The authors of the ACG poster did not report any financial conflicts. Dr. Hecht said he founded the Institute for Etiological Research to pursue questions about public health. Its funders include the Bertarelli Foundation.
, suggesting another field for inquiry about the potential role of industrial-produced edible food products in IBD.
The study, which was a meta-analysis of four studies, found a 47% greater risk of IBD in adults who consumed high levels of ultra-processed foods, compared with adults in reference groups.
“Our data are also consistent with other observational studies that found increased consumption of junk food, along with reduced intakes of fresh fruit and vegetables, are associated with the development of IBD. Because Americans consume over 60% of their calories in the form of ultra-processed foods, reductions in this level of consumption could meaningfully decrease the incidence of IBD,” wrote authors who were led by Eric Hecht, MD, PhD, MPH, president and executive director of the nonprofit Institute of Etiological Research, Boca Raton, Fla.
The potential effect of poor diet on the gut is a critical public health question, he said. Diet may be just one possible contributor to inflammatory bowel disease. Other contributors include genetics and having a compromised immune system.
Dr. Hecht and colleagues began this study with a search on the PubMed database of published research on IBD that included details of diet. Of 10 relevant studies, 4 studies met the inclusion criteria for the analysis.
The four studies included 652,880 adults, 2,240 cases of IBD with a follow-up period ranging from 2.3 to 22.3 years. Statistically significant elevated risks for both Crohn’s disease and ulcerative colitis were documented in the studies. There was a relative risk of 1.47 (95% confidence interval, 1.29-1.66) for IBD; 1.94 (95% CI, 1.45-2.58) for Crohn’s disease, and 1.26 (95% CI, 1.10-1.45) for ulcerative colitis.
Findings from the 4 studies
Chen et al. reported, in the Journal of Crohn’s and Colitis, the results of a cross-sectional and prospective cohort study of 187,854 adults who were followed for an average of 10 years. They found that a higher intake of ultra-processed foods was associated with a higher incidence of Crohn’s disease but not ulcerative colitis. It also found that people who were already diagnosed with an IBD consumed more ultra-processed foods than did those without a diagnosis. The authors called for further studies to address the impact of UPF intake.
Vasseur et al. documented, in Inflammatory Bowel Diseases, research drawn from the NutriNet-Santé Study, a large French web-based prospective study. It did not find that ultra-processed foods were significantly associated with the risk of incident IBD. But the authors noted that certain types of food items or dietary patterns could partly explain the increase in the incidence of IBD observed in several countries, saying that further large-scale studies would be needed to support pathophysiological assumptions made about the dietary risk factors and IBD.
In September 2020 in Gastroenterology, Lo et al. used data from the Nurses’ Health Study (1984-2014), Nurses’ Health Study II (1991-2015), and Health Professionals Follow-up Study (1986-2012). The authors reported finding dietary patterns associated with high inflammatory potential to be associated with increased risk of Crohn’s disease but not ulcerative colitis.
In October 2021 in Gastroenterology, Narula et al. reported finding no significant association between certain dietary patterns and risk of ulcerative colitis. There was some signal for Crohn’s disease, in keeping with findings from earlier research. Longer term follow-up is needed to clarify whether the observed excess risk for Crohn’s disease becomes more evident as more cases accumulate.
However, in an email interview with GI & Hepatology News, Neeraj Narula, MD, MPH, of McMaster University, Hamilton, Ont., cited two of his other published works that did make a connection between diet and IBD. In July 2021 in BMJ, he and colleagues reported findings of a prospective cohort study that found that higher intake of ultra-processed food was positively associated with risk of IBD. Further studies are needed to identify the contributory factors within ultra-processed foods, they wrote. He and colleagues published a meta-analysis of 5 cohort studies which concluded that higher ultra-processed food and lower unprocessed/minimally processed food intakes were associated with higher risk of Crohn’s disease but not ulcerative colitis.
Study limitations
Aviva Musicus, ScD, the science director for the nonprofit Center for Science in the Public Interest (CSPI), said the Dr. Hecht et al. meta-analysis suggests there could be a signal in the association between higher ultra-processed food consumption and IBD, but there’s also a lot of “noise” in this presentation.
It’s not clear from these analyses presented what might be driving the relationship between IBD and ultra-processed food, she said. “Is it the nutrient content of these foods, given that many are high in added sugar, sodium, and saturated fat and low in dietary fiber (potential risk factors for IBD)? Is it the emulsifiers used in some of these foods, or other chemicals added during processing? Or, is it something else?” Dr. Musicus said.
She said further studies are needed on the issue of ultra-processed food and IBD.
“I wasn’t convinced by the conclusion of this research abstract. It’s not clear to me that general reductions in UPF (ultra-processed foods) consumption could meaningfully decrease the incidence of IBD, given that it may be a subset of these (somewhat heterogeneous) foods driving the associations, and people may not reduce their consumption of that specific subset upon hearing this news,” Dr. Musicus said.
“However, we already know that consumers can reduce chronic disease risk by eating more vegetables, fruits, whole grains, and legumes (good sources of dietary fiber) and limiting consumption of added sugars, sodium, and saturated fat,” she added.
Miguel Regueiro, MD, chair of the Digestive Disease and Surgery Institute at Cleveland Clinic, agreed with the need for further study. There are limitations with the methodology used in the research from Dr. Hecht and colleagues, he said.
“Meta-analyses aren’t perfect and I think we all acknowledge that,” he said, adding that the Hecht poster provides “a larger perspective on the topic.”
There’s widespread agreement that ultraprocessed foods are not healthy, raising heart and cancer risks, he said. In counseling his patients, Dr. Regueiro said he acknowledges the challenges many people face in trying to pursue a healthier diet. Ultraprocessed foods tend to be cheap and readily available, and many people need help in spotting them, such as learning to look at labels for unfamiliar terms.
“What I tell my own patients in the clinic is to really try to clean up the diet as much as possible and in a realistic way,” he said.
The authors of the ACG poster did not report any financial conflicts. Dr. Hecht said he founded the Institute for Etiological Research to pursue questions about public health. Its funders include the Bertarelli Foundation.
, suggesting another field for inquiry about the potential role of industrial-produced edible food products in IBD.
The study, which was a meta-analysis of four studies, found a 47% greater risk of IBD in adults who consumed high levels of ultra-processed foods, compared with adults in reference groups.
“Our data are also consistent with other observational studies that found increased consumption of junk food, along with reduced intakes of fresh fruit and vegetables, are associated with the development of IBD. Because Americans consume over 60% of their calories in the form of ultra-processed foods, reductions in this level of consumption could meaningfully decrease the incidence of IBD,” wrote authors who were led by Eric Hecht, MD, PhD, MPH, president and executive director of the nonprofit Institute of Etiological Research, Boca Raton, Fla.
The potential effect of poor diet on the gut is a critical public health question, he said. Diet may be just one possible contributor to inflammatory bowel disease. Other contributors include genetics and having a compromised immune system.
Dr. Hecht and colleagues began this study with a search on the PubMed database of published research on IBD that included details of diet. Of 10 relevant studies, 4 studies met the inclusion criteria for the analysis.
The four studies included 652,880 adults, 2,240 cases of IBD with a follow-up period ranging from 2.3 to 22.3 years. Statistically significant elevated risks for both Crohn’s disease and ulcerative colitis were documented in the studies. There was a relative risk of 1.47 (95% confidence interval, 1.29-1.66) for IBD; 1.94 (95% CI, 1.45-2.58) for Crohn’s disease, and 1.26 (95% CI, 1.10-1.45) for ulcerative colitis.
Findings from the 4 studies
Chen et al. reported, in the Journal of Crohn’s and Colitis, the results of a cross-sectional and prospective cohort study of 187,854 adults who were followed for an average of 10 years. They found that a higher intake of ultra-processed foods was associated with a higher incidence of Crohn’s disease but not ulcerative colitis. It also found that people who were already diagnosed with an IBD consumed more ultra-processed foods than did those without a diagnosis. The authors called for further studies to address the impact of UPF intake.
Vasseur et al. documented, in Inflammatory Bowel Diseases, research drawn from the NutriNet-Santé Study, a large French web-based prospective study. It did not find that ultra-processed foods were significantly associated with the risk of incident IBD. But the authors noted that certain types of food items or dietary patterns could partly explain the increase in the incidence of IBD observed in several countries, saying that further large-scale studies would be needed to support pathophysiological assumptions made about the dietary risk factors and IBD.
In September 2020 in Gastroenterology, Lo et al. used data from the Nurses’ Health Study (1984-2014), Nurses’ Health Study II (1991-2015), and Health Professionals Follow-up Study (1986-2012). The authors reported finding dietary patterns associated with high inflammatory potential to be associated with increased risk of Crohn’s disease but not ulcerative colitis.
In October 2021 in Gastroenterology, Narula et al. reported finding no significant association between certain dietary patterns and risk of ulcerative colitis. There was some signal for Crohn’s disease, in keeping with findings from earlier research. Longer term follow-up is needed to clarify whether the observed excess risk for Crohn’s disease becomes more evident as more cases accumulate.
However, in an email interview with GI & Hepatology News, Neeraj Narula, MD, MPH, of McMaster University, Hamilton, Ont., cited two of his other published works that did make a connection between diet and IBD. In July 2021 in BMJ, he and colleagues reported findings of a prospective cohort study that found that higher intake of ultra-processed food was positively associated with risk of IBD. Further studies are needed to identify the contributory factors within ultra-processed foods, they wrote. He and colleagues published a meta-analysis of 5 cohort studies which concluded that higher ultra-processed food and lower unprocessed/minimally processed food intakes were associated with higher risk of Crohn’s disease but not ulcerative colitis.
Study limitations
Aviva Musicus, ScD, the science director for the nonprofit Center for Science in the Public Interest (CSPI), said the Dr. Hecht et al. meta-analysis suggests there could be a signal in the association between higher ultra-processed food consumption and IBD, but there’s also a lot of “noise” in this presentation.
It’s not clear from these analyses presented what might be driving the relationship between IBD and ultra-processed food, she said. “Is it the nutrient content of these foods, given that many are high in added sugar, sodium, and saturated fat and low in dietary fiber (potential risk factors for IBD)? Is it the emulsifiers used in some of these foods, or other chemicals added during processing? Or, is it something else?” Dr. Musicus said.
She said further studies are needed on the issue of ultra-processed food and IBD.
“I wasn’t convinced by the conclusion of this research abstract. It’s not clear to me that general reductions in UPF (ultra-processed foods) consumption could meaningfully decrease the incidence of IBD, given that it may be a subset of these (somewhat heterogeneous) foods driving the associations, and people may not reduce their consumption of that specific subset upon hearing this news,” Dr. Musicus said.
“However, we already know that consumers can reduce chronic disease risk by eating more vegetables, fruits, whole grains, and legumes (good sources of dietary fiber) and limiting consumption of added sugars, sodium, and saturated fat,” she added.
Miguel Regueiro, MD, chair of the Digestive Disease and Surgery Institute at Cleveland Clinic, agreed with the need for further study. There are limitations with the methodology used in the research from Dr. Hecht and colleagues, he said.
“Meta-analyses aren’t perfect and I think we all acknowledge that,” he said, adding that the Hecht poster provides “a larger perspective on the topic.”
There’s widespread agreement that ultraprocessed foods are not healthy, raising heart and cancer risks, he said. In counseling his patients, Dr. Regueiro said he acknowledges the challenges many people face in trying to pursue a healthier diet. Ultraprocessed foods tend to be cheap and readily available, and many people need help in spotting them, such as learning to look at labels for unfamiliar terms.
“What I tell my own patients in the clinic is to really try to clean up the diet as much as possible and in a realistic way,” he said.
The authors of the ACG poster did not report any financial conflicts. Dr. Hecht said he founded the Institute for Etiological Research to pursue questions about public health. Its funders include the Bertarelli Foundation.
FROM ACG 2023
Lack of medical device tracking leaves patients vulnerable
.
As a result of this siloing of information, patients are not getting the expected benefits of a regulation finalized over a decade ago by the U.S. Food and Drug Administration.
In 2013, the agency ordered companies to include unique device identifiers (UDIs) in plain-text and barcode format on some device labels, starting with implanted devices that are considered life-sustaining. The FDA said that tracking of UDI information would speed detection of complications linked to devices.
But identifiers are rarely on devices. At the time of the regulation creation, the FDA also said it expected this data would be integrated into EHRs. But only a few pioneer organizations such as Duke University and Mercy Health have so far attempted to track any UDI data in an organized way, researchers say.
Richard J. Kovacs, MD, the chief medical officer of the American College of Cardiology, contrasted the lack of useful implementation of UDI data with the speedy transfers of information that happen routinely in other industries. For example, employees of car rental agencies use handheld devices to gather detailed information about the vehicles being returned.
“But if you go to an emergency room with a medical device in your body, no one knows what it is or where it came from or anything about it,” Dr. Kovacs said in an interview.
Many physicians with expertise in device research have pushed for years to have insurers like Medicare require identification information on medical claims.
Even researchers face multiple obstacles in trying to investigate how well UDIs have been incorporated into EHRs and outcomes tied to certain devices.
In August, a Harvard team published a study in JAMA Internal Medicine, attempting to analyze the risks of endovascular aortic repair (EVAR) devices. They reported an 11.6% risk for serious blood leaks with AFX Endovascular AAA System aneurysm devices, more than double the 5.7% risk estimated for competing products. The team selected EVAR devices for the study due in part to their known safety concerns. Endologix, the maker of the devices, declined to comment for this story.
The Harvard team used data from the Veterans Affairs health system, which is considered more well organized than most other health systems. But UDI information was found for only 19 of the 13,941 patients whose records were studied. In those cases, only partial information was included.
The researchers developed natural language processing tools, which they used to scrounge clinical notes for information about which devices patients received.
Using this method isn’t feasible for most clinicians, given that records from independent hospitals might not provide this kind of data and descriptions to search, according to the authors of an editorial accompanying the paper. Those researchers urged Congress to pass a law mandating inclusion of UDIs for all devices on claims forms as a condition for reimbursement by federal health care programs.
Setback for advocates
The movement toward UDI suffered a setback in June.
An influential, but little known federal advisory panel, the National Committee on Vital Health Statistics (NCVHS), opted to not recommend use of this information in claims, saying the FDA should consider the matter further.
Gaining an NCVHS recommendation would have been a win, said Sen. Elizabeth Warren (D-MA), Sen. Charles E. Grassley (R-IA), and Rep. Bill Pascrell Jr. (D-NJ), in a December 2022 letter to the panel.
Including UDI data would let researchers track patients’ interactions with a health system and could be used to establish population-level correlations between a particular device and a long-term outcome or side effect, the lawmakers said.
That view had the support of at least one major maker of devices, Cook Group, which sells products for a variety of specialties, including cardiology.
In a comment to NCVHS, Cook urged for the inclusion identifiers in Medicare claims.
“While some have argued that the UDI is better suited for inclusion in the electronic health records, Cook believes this argument sets up a false choice between the two,” wrote Stephen L. Ferguson, JD, the chairman of Cook’s board. “Inclusion of the UDI in both electronic health records and claims forms will lead to a more robust system of real-world data.”
In contrast, AdvaMed, the trade group for device makers, told the NCVHS that it did not support adding the information to payment claims submissions, instead just supporting the inclusion in EHRs.
Dr. Kovacs of the ACC said one potential drawback to more transparency could be challenges in interpreting reports of complications in certain cases, at least initially. Reports about a flaw or even a suspected flaw in a device might lead patients to become concerned about their implanted devices, potentially registering unfounded complaints.
But this concern can be addressed through using “scientific rigor and safeguards” and is outweighed by the potential safety benefits for patients, Dr. Kovacs said.
Patients should ask health care systems to track and share information about their implanted devices, Dr. Kovacs suggested.
“I feel it would be my right to demand that that device information follows my electronic medical record, so that it’s readily available to anyone who’s taking care of me,” Dr. Kovacs said. “They would know what it is that’s in me, whether it’s a lens in my eye or a prosthesis in my hip or a highly complicated implantable cardiac electronic device.”
The Harvard study was supported by the FDA and National Institutes of Health. Authors of the study reported receiving fees from the FDA, Burroughs Wellcome Fund, and Harvard-MIT Center for Regulatory Science outside the submitted work. No other disclosures were reported. Authors of the editorial reported past and present connections with F-Prime Capital, FDA, Johnson & Johnson, the Medical Devices Innovation Consortium; the Agency for Healthcare Research and Quality; the National Heart, Lung, and Blood Institute; and Arnold Ventures, as well being an expert witness at in a qui tam suit alleging violations of the False Claims Act and Anti-Kickback Statute against Biogen. Authors of the Viewpoint reported past and present connections with the National Evaluation System for Health Technology Coordinating Center (NESTcc), which is part of the Medical Device Innovation Consortium (MDIC); AIM North America UDI Advisory Committee, Mass General Brigham, Arnold Ventures; the Institute for Clinical and Economic Review California Technology Assessment Forum; Yale University, Johnson & Johnson, FD, Agency for Healthcare Research and Quality; the National Heart, Lung, and Blood Institute of the National Institutes of Health; as well as having been an expert witness in a qui tam suit alleging violations of the False Claims Act and Anti-Kickback Statute against.
A version of this article first appeared on Medscape.com.
.
As a result of this siloing of information, patients are not getting the expected benefits of a regulation finalized over a decade ago by the U.S. Food and Drug Administration.
In 2013, the agency ordered companies to include unique device identifiers (UDIs) in plain-text and barcode format on some device labels, starting with implanted devices that are considered life-sustaining. The FDA said that tracking of UDI information would speed detection of complications linked to devices.
But identifiers are rarely on devices. At the time of the regulation creation, the FDA also said it expected this data would be integrated into EHRs. But only a few pioneer organizations such as Duke University and Mercy Health have so far attempted to track any UDI data in an organized way, researchers say.
Richard J. Kovacs, MD, the chief medical officer of the American College of Cardiology, contrasted the lack of useful implementation of UDI data with the speedy transfers of information that happen routinely in other industries. For example, employees of car rental agencies use handheld devices to gather detailed information about the vehicles being returned.
“But if you go to an emergency room with a medical device in your body, no one knows what it is or where it came from or anything about it,” Dr. Kovacs said in an interview.
Many physicians with expertise in device research have pushed for years to have insurers like Medicare require identification information on medical claims.
Even researchers face multiple obstacles in trying to investigate how well UDIs have been incorporated into EHRs and outcomes tied to certain devices.
In August, a Harvard team published a study in JAMA Internal Medicine, attempting to analyze the risks of endovascular aortic repair (EVAR) devices. They reported an 11.6% risk for serious blood leaks with AFX Endovascular AAA System aneurysm devices, more than double the 5.7% risk estimated for competing products. The team selected EVAR devices for the study due in part to their known safety concerns. Endologix, the maker of the devices, declined to comment for this story.
The Harvard team used data from the Veterans Affairs health system, which is considered more well organized than most other health systems. But UDI information was found for only 19 of the 13,941 patients whose records were studied. In those cases, only partial information was included.
The researchers developed natural language processing tools, which they used to scrounge clinical notes for information about which devices patients received.
Using this method isn’t feasible for most clinicians, given that records from independent hospitals might not provide this kind of data and descriptions to search, according to the authors of an editorial accompanying the paper. Those researchers urged Congress to pass a law mandating inclusion of UDIs for all devices on claims forms as a condition for reimbursement by federal health care programs.
Setback for advocates
The movement toward UDI suffered a setback in June.
An influential, but little known federal advisory panel, the National Committee on Vital Health Statistics (NCVHS), opted to not recommend use of this information in claims, saying the FDA should consider the matter further.
Gaining an NCVHS recommendation would have been a win, said Sen. Elizabeth Warren (D-MA), Sen. Charles E. Grassley (R-IA), and Rep. Bill Pascrell Jr. (D-NJ), in a December 2022 letter to the panel.
Including UDI data would let researchers track patients’ interactions with a health system and could be used to establish population-level correlations between a particular device and a long-term outcome or side effect, the lawmakers said.
That view had the support of at least one major maker of devices, Cook Group, which sells products for a variety of specialties, including cardiology.
In a comment to NCVHS, Cook urged for the inclusion identifiers in Medicare claims.
“While some have argued that the UDI is better suited for inclusion in the electronic health records, Cook believes this argument sets up a false choice between the two,” wrote Stephen L. Ferguson, JD, the chairman of Cook’s board. “Inclusion of the UDI in both electronic health records and claims forms will lead to a more robust system of real-world data.”
In contrast, AdvaMed, the trade group for device makers, told the NCVHS that it did not support adding the information to payment claims submissions, instead just supporting the inclusion in EHRs.
Dr. Kovacs of the ACC said one potential drawback to more transparency could be challenges in interpreting reports of complications in certain cases, at least initially. Reports about a flaw or even a suspected flaw in a device might lead patients to become concerned about their implanted devices, potentially registering unfounded complaints.
But this concern can be addressed through using “scientific rigor and safeguards” and is outweighed by the potential safety benefits for patients, Dr. Kovacs said.
Patients should ask health care systems to track and share information about their implanted devices, Dr. Kovacs suggested.
“I feel it would be my right to demand that that device information follows my electronic medical record, so that it’s readily available to anyone who’s taking care of me,” Dr. Kovacs said. “They would know what it is that’s in me, whether it’s a lens in my eye or a prosthesis in my hip or a highly complicated implantable cardiac electronic device.”
The Harvard study was supported by the FDA and National Institutes of Health. Authors of the study reported receiving fees from the FDA, Burroughs Wellcome Fund, and Harvard-MIT Center for Regulatory Science outside the submitted work. No other disclosures were reported. Authors of the editorial reported past and present connections with F-Prime Capital, FDA, Johnson & Johnson, the Medical Devices Innovation Consortium; the Agency for Healthcare Research and Quality; the National Heart, Lung, and Blood Institute; and Arnold Ventures, as well being an expert witness at in a qui tam suit alleging violations of the False Claims Act and Anti-Kickback Statute against Biogen. Authors of the Viewpoint reported past and present connections with the National Evaluation System for Health Technology Coordinating Center (NESTcc), which is part of the Medical Device Innovation Consortium (MDIC); AIM North America UDI Advisory Committee, Mass General Brigham, Arnold Ventures; the Institute for Clinical and Economic Review California Technology Assessment Forum; Yale University, Johnson & Johnson, FD, Agency for Healthcare Research and Quality; the National Heart, Lung, and Blood Institute of the National Institutes of Health; as well as having been an expert witness in a qui tam suit alleging violations of the False Claims Act and Anti-Kickback Statute against.
A version of this article first appeared on Medscape.com.
.
As a result of this siloing of information, patients are not getting the expected benefits of a regulation finalized over a decade ago by the U.S. Food and Drug Administration.
In 2013, the agency ordered companies to include unique device identifiers (UDIs) in plain-text and barcode format on some device labels, starting with implanted devices that are considered life-sustaining. The FDA said that tracking of UDI information would speed detection of complications linked to devices.
But identifiers are rarely on devices. At the time of the regulation creation, the FDA also said it expected this data would be integrated into EHRs. But only a few pioneer organizations such as Duke University and Mercy Health have so far attempted to track any UDI data in an organized way, researchers say.
Richard J. Kovacs, MD, the chief medical officer of the American College of Cardiology, contrasted the lack of useful implementation of UDI data with the speedy transfers of information that happen routinely in other industries. For example, employees of car rental agencies use handheld devices to gather detailed information about the vehicles being returned.
“But if you go to an emergency room with a medical device in your body, no one knows what it is or where it came from or anything about it,” Dr. Kovacs said in an interview.
Many physicians with expertise in device research have pushed for years to have insurers like Medicare require identification information on medical claims.
Even researchers face multiple obstacles in trying to investigate how well UDIs have been incorporated into EHRs and outcomes tied to certain devices.
In August, a Harvard team published a study in JAMA Internal Medicine, attempting to analyze the risks of endovascular aortic repair (EVAR) devices. They reported an 11.6% risk for serious blood leaks with AFX Endovascular AAA System aneurysm devices, more than double the 5.7% risk estimated for competing products. The team selected EVAR devices for the study due in part to their known safety concerns. Endologix, the maker of the devices, declined to comment for this story.
The Harvard team used data from the Veterans Affairs health system, which is considered more well organized than most other health systems. But UDI information was found for only 19 of the 13,941 patients whose records were studied. In those cases, only partial information was included.
The researchers developed natural language processing tools, which they used to scrounge clinical notes for information about which devices patients received.
Using this method isn’t feasible for most clinicians, given that records from independent hospitals might not provide this kind of data and descriptions to search, according to the authors of an editorial accompanying the paper. Those researchers urged Congress to pass a law mandating inclusion of UDIs for all devices on claims forms as a condition for reimbursement by federal health care programs.
Setback for advocates
The movement toward UDI suffered a setback in June.
An influential, but little known federal advisory panel, the National Committee on Vital Health Statistics (NCVHS), opted to not recommend use of this information in claims, saying the FDA should consider the matter further.
Gaining an NCVHS recommendation would have been a win, said Sen. Elizabeth Warren (D-MA), Sen. Charles E. Grassley (R-IA), and Rep. Bill Pascrell Jr. (D-NJ), in a December 2022 letter to the panel.
Including UDI data would let researchers track patients’ interactions with a health system and could be used to establish population-level correlations between a particular device and a long-term outcome or side effect, the lawmakers said.
That view had the support of at least one major maker of devices, Cook Group, which sells products for a variety of specialties, including cardiology.
In a comment to NCVHS, Cook urged for the inclusion identifiers in Medicare claims.
“While some have argued that the UDI is better suited for inclusion in the electronic health records, Cook believes this argument sets up a false choice between the two,” wrote Stephen L. Ferguson, JD, the chairman of Cook’s board. “Inclusion of the UDI in both electronic health records and claims forms will lead to a more robust system of real-world data.”
In contrast, AdvaMed, the trade group for device makers, told the NCVHS that it did not support adding the information to payment claims submissions, instead just supporting the inclusion in EHRs.
Dr. Kovacs of the ACC said one potential drawback to more transparency could be challenges in interpreting reports of complications in certain cases, at least initially. Reports about a flaw or even a suspected flaw in a device might lead patients to become concerned about their implanted devices, potentially registering unfounded complaints.
But this concern can be addressed through using “scientific rigor and safeguards” and is outweighed by the potential safety benefits for patients, Dr. Kovacs said.
Patients should ask health care systems to track and share information about their implanted devices, Dr. Kovacs suggested.
“I feel it would be my right to demand that that device information follows my electronic medical record, so that it’s readily available to anyone who’s taking care of me,” Dr. Kovacs said. “They would know what it is that’s in me, whether it’s a lens in my eye or a prosthesis in my hip or a highly complicated implantable cardiac electronic device.”
The Harvard study was supported by the FDA and National Institutes of Health. Authors of the study reported receiving fees from the FDA, Burroughs Wellcome Fund, and Harvard-MIT Center for Regulatory Science outside the submitted work. No other disclosures were reported. Authors of the editorial reported past and present connections with F-Prime Capital, FDA, Johnson & Johnson, the Medical Devices Innovation Consortium; the Agency for Healthcare Research and Quality; the National Heart, Lung, and Blood Institute; and Arnold Ventures, as well being an expert witness at in a qui tam suit alleging violations of the False Claims Act and Anti-Kickback Statute against Biogen. Authors of the Viewpoint reported past and present connections with the National Evaluation System for Health Technology Coordinating Center (NESTcc), which is part of the Medical Device Innovation Consortium (MDIC); AIM North America UDI Advisory Committee, Mass General Brigham, Arnold Ventures; the Institute for Clinical and Economic Review California Technology Assessment Forum; Yale University, Johnson & Johnson, FD, Agency for Healthcare Research and Quality; the National Heart, Lung, and Blood Institute of the National Institutes of Health; as well as having been an expert witness in a qui tam suit alleging violations of the False Claims Act and Anti-Kickback Statute against.
A version of this article first appeared on Medscape.com.
CPT updates for 2024 include new RSV vaccines, Spanish translation
The American Medical Association recently released the Current Procedural Terminology (CPT) 2024 Code Set. The update included 349 editorial changes, including 230 additions, 49 deletions, and 70 revisions. With more than 11,100 codes in use, the CPT system continues “to grow and evolve with the rapid pace of innovation in medical science and health technology,” AMA said.
The AMA said the CPT update includes five new codes created to report product-specific RSV products (90380, 90381, 90683, 90679, and 90678) for better tracking, reporting and analysis that supports data-driven planning and allocation, AMA said.
There’s been a flurry of new U.S. vaccines and drugs to address RSV. The Food and Drug Administration in May granted the first U.S. approval of an RSV vaccine to Arexy, manufactured by GSK. The FDA cleared it for prevention of lower respiratory tract disease caused by RSV in adults age 60 years and older.
In June, Pfizer won FDA approval of Abrysvo, another vaccine meant to protect adults older than 60 years from RSV. The following month, the FDA approved nirsevimab (Beyfortus, AstraZeneca/Sanofi), for the prevention of RSV in neonates and infants entering their first RSV season, and in children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season. (This is not a vaccine, but a monoclonal antibody used for prevention. There has been confusion on this issue in part because monoclonal antibodies are often used for treatment rather than prevention.)
The FDA also has approved Abrysvo for use in pregnant individuals.
In addition, new CPT codes aim to streamline COVID-19 immunizations reporting. A new code (90480) was approved for reporting the administration of any COVID-19 vaccine for any patient. New provisional codes (91318-91322) will identify monovalent vaccine products from Moderna and Pfizer for immunization against COVID-19.
These provisional codes will be effective for use when the monovalent vaccine products from Moderna and Pfizer receive FDA approval, AMA said.
More codes explained in Spanish
The 2024 update includes more code descriptions in Spanish. Many hospitals, health plans, and medical offices already incorporate CPT descriptors in English-language medical documents, insurance forms, price sheets, and patient portals. This expansion is intended to help patients who may not read English well or at all.
“Providing approximately 41 million Spanish-speaking individuals in the United States with an easy-to-understand description of medical procedures and services can help build a more inclusive health care environment, where language is no longer a barrier and patients can actively engage in their own care,” Lori Prestesater, AMA’s senior vice president of health solutions, said in a statement.
In addition, the 2024 update includes clarifications sought by the Centers for Medicare & Medicaid Services about the reporting of evaluation and management (E/M) services. The revisions include:
- Removal of time ranges from office or other outpatient visit codes (99202-99205, 99212-99215) and format alignment with other E/M codes.
- Definition of the “substantive portion” of a split/shared E/M visit in which a physician and a nonphysician practitioner work jointly to furnish all the work related to the visit.
- Instructions for reporting hospital inpatient or observation care services and admission and discharge services for the use of codes. 99234-99236 when the patient stay crosses over two calendar dates.
A version of this article appeared on Medscape.com.
The American Medical Association recently released the Current Procedural Terminology (CPT) 2024 Code Set. The update included 349 editorial changes, including 230 additions, 49 deletions, and 70 revisions. With more than 11,100 codes in use, the CPT system continues “to grow and evolve with the rapid pace of innovation in medical science and health technology,” AMA said.
The AMA said the CPT update includes five new codes created to report product-specific RSV products (90380, 90381, 90683, 90679, and 90678) for better tracking, reporting and analysis that supports data-driven planning and allocation, AMA said.
There’s been a flurry of new U.S. vaccines and drugs to address RSV. The Food and Drug Administration in May granted the first U.S. approval of an RSV vaccine to Arexy, manufactured by GSK. The FDA cleared it for prevention of lower respiratory tract disease caused by RSV in adults age 60 years and older.
In June, Pfizer won FDA approval of Abrysvo, another vaccine meant to protect adults older than 60 years from RSV. The following month, the FDA approved nirsevimab (Beyfortus, AstraZeneca/Sanofi), for the prevention of RSV in neonates and infants entering their first RSV season, and in children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season. (This is not a vaccine, but a monoclonal antibody used for prevention. There has been confusion on this issue in part because monoclonal antibodies are often used for treatment rather than prevention.)
The FDA also has approved Abrysvo for use in pregnant individuals.
In addition, new CPT codes aim to streamline COVID-19 immunizations reporting. A new code (90480) was approved for reporting the administration of any COVID-19 vaccine for any patient. New provisional codes (91318-91322) will identify monovalent vaccine products from Moderna and Pfizer for immunization against COVID-19.
These provisional codes will be effective for use when the monovalent vaccine products from Moderna and Pfizer receive FDA approval, AMA said.
More codes explained in Spanish
The 2024 update includes more code descriptions in Spanish. Many hospitals, health plans, and medical offices already incorporate CPT descriptors in English-language medical documents, insurance forms, price sheets, and patient portals. This expansion is intended to help patients who may not read English well or at all.
“Providing approximately 41 million Spanish-speaking individuals in the United States with an easy-to-understand description of medical procedures and services can help build a more inclusive health care environment, where language is no longer a barrier and patients can actively engage in their own care,” Lori Prestesater, AMA’s senior vice president of health solutions, said in a statement.
In addition, the 2024 update includes clarifications sought by the Centers for Medicare & Medicaid Services about the reporting of evaluation and management (E/M) services. The revisions include:
- Removal of time ranges from office or other outpatient visit codes (99202-99205, 99212-99215) and format alignment with other E/M codes.
- Definition of the “substantive portion” of a split/shared E/M visit in which a physician and a nonphysician practitioner work jointly to furnish all the work related to the visit.
- Instructions for reporting hospital inpatient or observation care services and admission and discharge services for the use of codes. 99234-99236 when the patient stay crosses over two calendar dates.
A version of this article appeared on Medscape.com.
The American Medical Association recently released the Current Procedural Terminology (CPT) 2024 Code Set. The update included 349 editorial changes, including 230 additions, 49 deletions, and 70 revisions. With more than 11,100 codes in use, the CPT system continues “to grow and evolve with the rapid pace of innovation in medical science and health technology,” AMA said.
The AMA said the CPT update includes five new codes created to report product-specific RSV products (90380, 90381, 90683, 90679, and 90678) for better tracking, reporting and analysis that supports data-driven planning and allocation, AMA said.
There’s been a flurry of new U.S. vaccines and drugs to address RSV. The Food and Drug Administration in May granted the first U.S. approval of an RSV vaccine to Arexy, manufactured by GSK. The FDA cleared it for prevention of lower respiratory tract disease caused by RSV in adults age 60 years and older.
In June, Pfizer won FDA approval of Abrysvo, another vaccine meant to protect adults older than 60 years from RSV. The following month, the FDA approved nirsevimab (Beyfortus, AstraZeneca/Sanofi), for the prevention of RSV in neonates and infants entering their first RSV season, and in children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season. (This is not a vaccine, but a monoclonal antibody used for prevention. There has been confusion on this issue in part because monoclonal antibodies are often used for treatment rather than prevention.)
The FDA also has approved Abrysvo for use in pregnant individuals.
In addition, new CPT codes aim to streamline COVID-19 immunizations reporting. A new code (90480) was approved for reporting the administration of any COVID-19 vaccine for any patient. New provisional codes (91318-91322) will identify monovalent vaccine products from Moderna and Pfizer for immunization against COVID-19.
These provisional codes will be effective for use when the monovalent vaccine products from Moderna and Pfizer receive FDA approval, AMA said.
More codes explained in Spanish
The 2024 update includes more code descriptions in Spanish. Many hospitals, health plans, and medical offices already incorporate CPT descriptors in English-language medical documents, insurance forms, price sheets, and patient portals. This expansion is intended to help patients who may not read English well or at all.
“Providing approximately 41 million Spanish-speaking individuals in the United States with an easy-to-understand description of medical procedures and services can help build a more inclusive health care environment, where language is no longer a barrier and patients can actively engage in their own care,” Lori Prestesater, AMA’s senior vice president of health solutions, said in a statement.
In addition, the 2024 update includes clarifications sought by the Centers for Medicare & Medicaid Services about the reporting of evaluation and management (E/M) services. The revisions include:
- Removal of time ranges from office or other outpatient visit codes (99202-99205, 99212-99215) and format alignment with other E/M codes.
- Definition of the “substantive portion” of a split/shared E/M visit in which a physician and a nonphysician practitioner work jointly to furnish all the work related to the visit.
- Instructions for reporting hospital inpatient or observation care services and admission and discharge services for the use of codes. 99234-99236 when the patient stay crosses over two calendar dates.
A version of this article appeared on Medscape.com.
FDA to step up oversight of cosmetics, assess ‘forever chemicals’
They are also preparing to assess potential risks of so-called forever chemicals in these products.
The Food and Drug Administration last year gained new authority over cosmetics when Congress passed the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) by adding this bill to a December budget package.
“On average, consumers in the U.S. use six to 12 cosmetics products daily. But, until recently the FDA didn’t have the authority to require manufacturers to submit cosmetic product listings, including a list of ingredients used in these products, or register the facilities where they were produced,” Namandjé Bumpus, PhD, FDA’s chief scientist, said in a press release.
In the statement, the FDA announced the release of a draft guidance document that is intended to help companies comply with the transparency requirements slated to kick in this December. The agency is accepting comments on this draft guidance through Sept. 7.
“Later this year, registration and listing of cosmetic product facilities and products will become a requirement, making information about cosmetic products, including the ingredients used in products and the facilities where they are produced, readily available to the agency,” Dr. Bumpus said.
The products, according to the FDA statement, include makeup, nail polishes, shaving creams, other grooming products, perfumes, face and body cleansers, hair products, moisturizers, and other skin care items.
MoCRA “represents a sea change in how FDA regulates the cosmetics industry,” attorneys Frederick R. Ball, Alyson Walker Lotman, and Kelly A. Bonner, wrote in an article for the Food and Drug Law Institute published in spring 2023.
The FDA has called the MoCRA law “the most significant expansion” of its authority to regulate cosmetics since the Federal Food, Drug, and Cosmetic Act was passed in 1938.
The agency is in the process of expanding its staff to carry out newly authorized duties, including the tracking of adverse events. The FDA budget request for fiscal 2024, which begins Oct. 1, seeks $5 million for work needed to implement MoCRA.
PFAS, or ‘forever chemicals’
Some of the requested FDA funding is intended to prepare the agency to assess the use of per-and polyfluoroalkyl substances (PFAS) in cosmetics.
MoCRA sets a 3-year deadline for the FDA to issue an assessment of the use and potential risks of PFAS in cosmetics products. PFAS are sometimes added as ingredients in some cosmetic products, including lotions, cleansers, nail polish, shaving cream, foundation, lipstick, eyeliner, eyeshadow, and mascara, according to the FDA. Sometimes the presence of PFAS in cosmetics is unintentional and is the result of impurities in raw materials or is due to the breakdown of ingredients, the FDA said.
The FDA’s website says that so far, the available research doesn’t allow for “definitive conclusions about the potential health risks of PFAS in cosmetics.”
The Centers for Disease Control and Prevention has stated that research has suggested potential links between high levels of certain PFAS, in general, with increased cholesterol levels, changes in liver enzyme levels, increased risk of hypertension or preeclampsia in pregnant women, and increased risk of kidney or testicular cancer.
PFAS compounds often are used to resist grease, oil, water, and heat in industrial settings. They are used in thousands of products, from nonstick cookware to firefighting foams and protective gear, because they can reduce friction, according to a National Academies of Sciences, Engineering, and Medicine report on PFAS that was issued last year.
PFAS are known as “forever chemicals” because they contain a carbon-fluorine bond, which does not break naturally. Even when PFAS are transformed in the body, they can assume other forms of PFAS that preserve the troublesome carbon-fluorine bond. With PFAS, the human body is confronted with a substance it doesn’t have the tools to process.
This is in contrast to proteins and carbohydrates, which are in a sense prepackaged for relatively easy disassembly in the human body. Many of these compounds have weak links that enzymes and stomach acid can take apart, such as sulfur-to-sulfur (disulfide) bonds. That’s why protein-based biotech drugs are injected instead of administered as pills. The ultimate goal of this digestion is for the body to gain energy from these compounds.
But with PFAS, the body faces the challenge of carbon-fluorine bonds that are very hard to break down, and there is no payoff for these efforts, Graham F. Peaslee, PhD, professor of physics at the University of Notre Dame (Indiana), told this news organization.
“Nothing will naturally eat it because when you break the bond, it’s like eating celery,” he said. “You use more calories to eat the celery than you gain back from it.”
Interest from a U.S. senator
Dr. Peaslee was one of the authors of a 2021 article about PFAS in cosmetics that appeared in the journal Environmental Science and Technology Letters.
In the article, Dr. Peaslee and colleagues reported on their screening of 231 cosmetic products purchased in the United States and Canada using particle-induced gamma-ray emission spectroscopy. They found cases of undisclosed PFAS in cosmetic products. Foundations, mascaras, and lip products were noted as being especially problematic.
Sen. Susan Collins (R-ME) cited Dr. Peaslee’s article in a 2021 floor speech as she argued for having the FDA ban the intentional addition of PFAS to cosmetics.
“The findings of this study are particularly alarming, as many of these products are subject to direct human exposure,” Sen. Collins said. “For example, lipstick is often inadvertently ingested, and mascara is sometimes absorbed through tear ducts.”
In addition, workers at cosmetics plants may be exposed to PFAS and discarded cosmetics that have these compounds, which could potentially contaminate drinking water, Sen. Collins said. In 2021, she introduced legislation seeking a ban on PFAS that are intentionally added to cosmetics. That legislation did not advance through the Senate.
But the Senate Appropriations Committee, on which Sen. Collins is the ranking Republican, wants the FDA to keep a ban on PFAS in mind.
The Senate Agriculture Appropriations subcommittee, which oversees the FDA’s budget, raised the issue of PFAS and cosmetics in a June report. The FDA should develop a plan outlining research needed to inform “regulatory decision making, including potential development of a proposed rule to ban intentionally added PFAS substances in cosmetics,” the subcommittee said.
A version of this article first appeared on Medscape.com.
They are also preparing to assess potential risks of so-called forever chemicals in these products.
The Food and Drug Administration last year gained new authority over cosmetics when Congress passed the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) by adding this bill to a December budget package.
“On average, consumers in the U.S. use six to 12 cosmetics products daily. But, until recently the FDA didn’t have the authority to require manufacturers to submit cosmetic product listings, including a list of ingredients used in these products, or register the facilities where they were produced,” Namandjé Bumpus, PhD, FDA’s chief scientist, said in a press release.
In the statement, the FDA announced the release of a draft guidance document that is intended to help companies comply with the transparency requirements slated to kick in this December. The agency is accepting comments on this draft guidance through Sept. 7.
“Later this year, registration and listing of cosmetic product facilities and products will become a requirement, making information about cosmetic products, including the ingredients used in products and the facilities where they are produced, readily available to the agency,” Dr. Bumpus said.
The products, according to the FDA statement, include makeup, nail polishes, shaving creams, other grooming products, perfumes, face and body cleansers, hair products, moisturizers, and other skin care items.
MoCRA “represents a sea change in how FDA regulates the cosmetics industry,” attorneys Frederick R. Ball, Alyson Walker Lotman, and Kelly A. Bonner, wrote in an article for the Food and Drug Law Institute published in spring 2023.
The FDA has called the MoCRA law “the most significant expansion” of its authority to regulate cosmetics since the Federal Food, Drug, and Cosmetic Act was passed in 1938.
The agency is in the process of expanding its staff to carry out newly authorized duties, including the tracking of adverse events. The FDA budget request for fiscal 2024, which begins Oct. 1, seeks $5 million for work needed to implement MoCRA.
PFAS, or ‘forever chemicals’
Some of the requested FDA funding is intended to prepare the agency to assess the use of per-and polyfluoroalkyl substances (PFAS) in cosmetics.
MoCRA sets a 3-year deadline for the FDA to issue an assessment of the use and potential risks of PFAS in cosmetics products. PFAS are sometimes added as ingredients in some cosmetic products, including lotions, cleansers, nail polish, shaving cream, foundation, lipstick, eyeliner, eyeshadow, and mascara, according to the FDA. Sometimes the presence of PFAS in cosmetics is unintentional and is the result of impurities in raw materials or is due to the breakdown of ingredients, the FDA said.
The FDA’s website says that so far, the available research doesn’t allow for “definitive conclusions about the potential health risks of PFAS in cosmetics.”
The Centers for Disease Control and Prevention has stated that research has suggested potential links between high levels of certain PFAS, in general, with increased cholesterol levels, changes in liver enzyme levels, increased risk of hypertension or preeclampsia in pregnant women, and increased risk of kidney or testicular cancer.
PFAS compounds often are used to resist grease, oil, water, and heat in industrial settings. They are used in thousands of products, from nonstick cookware to firefighting foams and protective gear, because they can reduce friction, according to a National Academies of Sciences, Engineering, and Medicine report on PFAS that was issued last year.
PFAS are known as “forever chemicals” because they contain a carbon-fluorine bond, which does not break naturally. Even when PFAS are transformed in the body, they can assume other forms of PFAS that preserve the troublesome carbon-fluorine bond. With PFAS, the human body is confronted with a substance it doesn’t have the tools to process.
This is in contrast to proteins and carbohydrates, which are in a sense prepackaged for relatively easy disassembly in the human body. Many of these compounds have weak links that enzymes and stomach acid can take apart, such as sulfur-to-sulfur (disulfide) bonds. That’s why protein-based biotech drugs are injected instead of administered as pills. The ultimate goal of this digestion is for the body to gain energy from these compounds.
But with PFAS, the body faces the challenge of carbon-fluorine bonds that are very hard to break down, and there is no payoff for these efforts, Graham F. Peaslee, PhD, professor of physics at the University of Notre Dame (Indiana), told this news organization.
“Nothing will naturally eat it because when you break the bond, it’s like eating celery,” he said. “You use more calories to eat the celery than you gain back from it.”
Interest from a U.S. senator
Dr. Peaslee was one of the authors of a 2021 article about PFAS in cosmetics that appeared in the journal Environmental Science and Technology Letters.
In the article, Dr. Peaslee and colleagues reported on their screening of 231 cosmetic products purchased in the United States and Canada using particle-induced gamma-ray emission spectroscopy. They found cases of undisclosed PFAS in cosmetic products. Foundations, mascaras, and lip products were noted as being especially problematic.
Sen. Susan Collins (R-ME) cited Dr. Peaslee’s article in a 2021 floor speech as she argued for having the FDA ban the intentional addition of PFAS to cosmetics.
“The findings of this study are particularly alarming, as many of these products are subject to direct human exposure,” Sen. Collins said. “For example, lipstick is often inadvertently ingested, and mascara is sometimes absorbed through tear ducts.”
In addition, workers at cosmetics plants may be exposed to PFAS and discarded cosmetics that have these compounds, which could potentially contaminate drinking water, Sen. Collins said. In 2021, she introduced legislation seeking a ban on PFAS that are intentionally added to cosmetics. That legislation did not advance through the Senate.
But the Senate Appropriations Committee, on which Sen. Collins is the ranking Republican, wants the FDA to keep a ban on PFAS in mind.
The Senate Agriculture Appropriations subcommittee, which oversees the FDA’s budget, raised the issue of PFAS and cosmetics in a June report. The FDA should develop a plan outlining research needed to inform “regulatory decision making, including potential development of a proposed rule to ban intentionally added PFAS substances in cosmetics,” the subcommittee said.
A version of this article first appeared on Medscape.com.
They are also preparing to assess potential risks of so-called forever chemicals in these products.
The Food and Drug Administration last year gained new authority over cosmetics when Congress passed the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) by adding this bill to a December budget package.
“On average, consumers in the U.S. use six to 12 cosmetics products daily. But, until recently the FDA didn’t have the authority to require manufacturers to submit cosmetic product listings, including a list of ingredients used in these products, or register the facilities where they were produced,” Namandjé Bumpus, PhD, FDA’s chief scientist, said in a press release.
In the statement, the FDA announced the release of a draft guidance document that is intended to help companies comply with the transparency requirements slated to kick in this December. The agency is accepting comments on this draft guidance through Sept. 7.
“Later this year, registration and listing of cosmetic product facilities and products will become a requirement, making information about cosmetic products, including the ingredients used in products and the facilities where they are produced, readily available to the agency,” Dr. Bumpus said.
The products, according to the FDA statement, include makeup, nail polishes, shaving creams, other grooming products, perfumes, face and body cleansers, hair products, moisturizers, and other skin care items.
MoCRA “represents a sea change in how FDA regulates the cosmetics industry,” attorneys Frederick R. Ball, Alyson Walker Lotman, and Kelly A. Bonner, wrote in an article for the Food and Drug Law Institute published in spring 2023.
The FDA has called the MoCRA law “the most significant expansion” of its authority to regulate cosmetics since the Federal Food, Drug, and Cosmetic Act was passed in 1938.
The agency is in the process of expanding its staff to carry out newly authorized duties, including the tracking of adverse events. The FDA budget request for fiscal 2024, which begins Oct. 1, seeks $5 million for work needed to implement MoCRA.
PFAS, or ‘forever chemicals’
Some of the requested FDA funding is intended to prepare the agency to assess the use of per-and polyfluoroalkyl substances (PFAS) in cosmetics.
MoCRA sets a 3-year deadline for the FDA to issue an assessment of the use and potential risks of PFAS in cosmetics products. PFAS are sometimes added as ingredients in some cosmetic products, including lotions, cleansers, nail polish, shaving cream, foundation, lipstick, eyeliner, eyeshadow, and mascara, according to the FDA. Sometimes the presence of PFAS in cosmetics is unintentional and is the result of impurities in raw materials or is due to the breakdown of ingredients, the FDA said.
The FDA’s website says that so far, the available research doesn’t allow for “definitive conclusions about the potential health risks of PFAS in cosmetics.”
The Centers for Disease Control and Prevention has stated that research has suggested potential links between high levels of certain PFAS, in general, with increased cholesterol levels, changes in liver enzyme levels, increased risk of hypertension or preeclampsia in pregnant women, and increased risk of kidney or testicular cancer.
PFAS compounds often are used to resist grease, oil, water, and heat in industrial settings. They are used in thousands of products, from nonstick cookware to firefighting foams and protective gear, because they can reduce friction, according to a National Academies of Sciences, Engineering, and Medicine report on PFAS that was issued last year.
PFAS are known as “forever chemicals” because they contain a carbon-fluorine bond, which does not break naturally. Even when PFAS are transformed in the body, they can assume other forms of PFAS that preserve the troublesome carbon-fluorine bond. With PFAS, the human body is confronted with a substance it doesn’t have the tools to process.
This is in contrast to proteins and carbohydrates, which are in a sense prepackaged for relatively easy disassembly in the human body. Many of these compounds have weak links that enzymes and stomach acid can take apart, such as sulfur-to-sulfur (disulfide) bonds. That’s why protein-based biotech drugs are injected instead of administered as pills. The ultimate goal of this digestion is for the body to gain energy from these compounds.
But with PFAS, the body faces the challenge of carbon-fluorine bonds that are very hard to break down, and there is no payoff for these efforts, Graham F. Peaslee, PhD, professor of physics at the University of Notre Dame (Indiana), told this news organization.
“Nothing will naturally eat it because when you break the bond, it’s like eating celery,” he said. “You use more calories to eat the celery than you gain back from it.”
Interest from a U.S. senator
Dr. Peaslee was one of the authors of a 2021 article about PFAS in cosmetics that appeared in the journal Environmental Science and Technology Letters.
In the article, Dr. Peaslee and colleagues reported on their screening of 231 cosmetic products purchased in the United States and Canada using particle-induced gamma-ray emission spectroscopy. They found cases of undisclosed PFAS in cosmetic products. Foundations, mascaras, and lip products were noted as being especially problematic.
Sen. Susan Collins (R-ME) cited Dr. Peaslee’s article in a 2021 floor speech as she argued for having the FDA ban the intentional addition of PFAS to cosmetics.
“The findings of this study are particularly alarming, as many of these products are subject to direct human exposure,” Sen. Collins said. “For example, lipstick is often inadvertently ingested, and mascara is sometimes absorbed through tear ducts.”
In addition, workers at cosmetics plants may be exposed to PFAS and discarded cosmetics that have these compounds, which could potentially contaminate drinking water, Sen. Collins said. In 2021, she introduced legislation seeking a ban on PFAS that are intentionally added to cosmetics. That legislation did not advance through the Senate.
But the Senate Appropriations Committee, on which Sen. Collins is the ranking Republican, wants the FDA to keep a ban on PFAS in mind.
The Senate Agriculture Appropriations subcommittee, which oversees the FDA’s budget, raised the issue of PFAS and cosmetics in a June report. The FDA should develop a plan outlining research needed to inform “regulatory decision making, including potential development of a proposed rule to ban intentionally added PFAS substances in cosmetics,” the subcommittee said.
A version of this article first appeared on Medscape.com.
Medicare announces 10 drugs targeted for price cuts in 2026
People on Medicare may in 2026 see prices drop for 10 medicines, including pricey diabetes, cancer, blood clot, and arthritis treatments, if advocates for federal drug-price negotiations can implement their plans amid tough opposition.
It’s unclear at this time, though, how these negotiations will play out. The Chamber of Commerce has sided with pharmaceutical companies in bids to block direct Medicare negotiation of drug prices. Many influential Republicans in Congress oppose this plan, which has deep support from both Democrats and AARP.
While facing strong opposition to negotiations, the Centers for Medicare & Medicaid Services sought in its announcement to illustrate the high costs of the selected medicines.
CMS provided data on total Part D costs for selected medicines for the period from June 2022 to May 2023, along with tallies of the number of people taking these drugs. The 10 selected medicines are as follows:
- Eliquis (generic name: apixaban), used to prevent and treat serious blood clots. It is taken by about 3.7 million people through Part D plans. The estimated cost is $16.4 billion.
- Jardiance (generic name: empagliflozin), used for diabetes and heart failure. It is taken by almost 1.6 million people through Part D plans. The estimated cost is $7.06 billion.
- Xarelto (generic name: rivaroxaban), used for blood clots. It is taken by about 1.3 million people through Part D plans. The estimated cost is $6 billion.
- Januvia (generic name: sitagliptin), used for diabetes. It is taken by about 869,00 people through Part D plans. The estimated cost is $4.1 billion.
- Farxiga (generic name: dapagliflozin), used for diabetes, heart failure, and chronic kidney disease. It is taken by about 799,000 people through Part D plans. The estimated cost is almost $3.3 billion.
- Entresto (generic name: sacubitril/valsartan), used to treat heart failure. It is taken by 587,000 people through Part D plans. The estimated cost is $2.9 billion.
- Enbrel( generic name: etanercept), used for rheumatoid arthritis, psoriasis, and psoriatic arthritis. It is taken by 48,000 people through Part D plans. The estimated cost is $2.8 billion.
- Imbruvica (generic name: ibrutinib), used to treat some blood cancers. It is taken by about 20,000 people in Part D plans. The estimated cost is $2.7 billion.
- Stelara (generic name: ustekinumab), used to treat plaque psoriasis, psoriatic arthritis, or certain bowel conditions (Crohn’s disease, ulcerative colitis). It is used by about 22,000 people through Part D plans. The estimated cost is $2.6 billion.
- Fiasp; Fiasp FlexTouch; Fiasp PenFill; NovoLog; NovoLog FlexPen; NovoLog PenFill. These are forms of insulin used to treat diabetes. They are used by about 777,000 people through Part D plans. The estimated cost is $2.6 billion.
A vocal critic of Medicare drug negotiations, Joel White, president of the Council for Affordable Health Coverage, called the announcement of the 10 drugs selected for negotiation “a hollow victory lap.” A former Republican staffer on the House Ways and Means Committee, Mr. White aided with the development of the Medicare Part D plans and has kept tabs on the pharmacy programs since its launch in 2006.
“No one’s costs will go down now or for years because of this announcement” about Part D negotiations, Mr. White said in a statement.
According to its website, CAHC includes among its members the American Academy of Ophthalmology as well as some patient groups, drugmakers, such as Johnson & Johnson, and insurers and industry groups, such as the National Association of Manufacturers.
Separately, the influential Chamber of Commerce is making a strong push to at least delay the implementation of the Medicare Part D drug negotiations. On Aug. 28, the chamber released a letter sent to the Biden administration, raising concerns about a “rush” to implement the provisions of the Inflation Reduction Act.
The chamber also has filed suit to challenge the drug negotiation provisions of the Inflation Reduction Act, requesting that the court issue a preliminary injunction by Oct. 1, 2023.
Other pending legal challenges to direct Medicare drug negotiations include suits filed by Merck, Bristol-Myers Squibb, Johnson & Johnson, Boehringer Ingelheim, and AstraZeneca, according to an email from Pharmaceutical Research and Manufacturers of America. PhRMA also said it is a party to a case.
In addition, the three congressional Republicans with most direct influence over Medicare policy issued on Aug. 29 a joint statement outlining their objections to the planned negotiations on drug prices.
This drug-negotiation proposal is “an unworkable, legally dubious scheme that will lead to higher prices for new drugs coming to market, stifle the development of new cures, and destroy jobs,” said House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-Wash.), House Ways and Means Committee Chair Jason Smith (R-Mo.), and Senate Finance Committee Ranking Member Mike Crapo (R-Idaho).
Democrats were equally firm and vocal in their support of the negotiations. Senate Finance Chairman Ron Wyden (D-Ore.) issued a statement on Aug. 29 that said the release of the list of the 10 drugs selected for Medicare drug negotiations is part of a “seismic shift in the relationship between Big Pharma, the federal government, and seniors who are counting on lower prices.
“I will be following the negotiation process closely and will fight any attempt by Big Pharma to undo or undermine the progress that’s been made,” Mr. Wyden said.
In addition, AARP issued a statement of its continued support for Medicare drug negotiations.
“The No. 1 reason seniors skip or ration their prescriptions is because they can’t afford them. This must stop,” said AARP executive vice president and chief advocacy and engagement officer Nancy LeaMond in the statement. “The big drug companies and their allies continue suing to overturn the Medicare drug price negotiation program to keep up their price gouging. We can’t allow seniors to be Big Pharma’s cash machine anymore.”
A version of this article first appeared on Medscape.com.
People on Medicare may in 2026 see prices drop for 10 medicines, including pricey diabetes, cancer, blood clot, and arthritis treatments, if advocates for federal drug-price negotiations can implement their plans amid tough opposition.
It’s unclear at this time, though, how these negotiations will play out. The Chamber of Commerce has sided with pharmaceutical companies in bids to block direct Medicare negotiation of drug prices. Many influential Republicans in Congress oppose this plan, which has deep support from both Democrats and AARP.
While facing strong opposition to negotiations, the Centers for Medicare & Medicaid Services sought in its announcement to illustrate the high costs of the selected medicines.
CMS provided data on total Part D costs for selected medicines for the period from June 2022 to May 2023, along with tallies of the number of people taking these drugs. The 10 selected medicines are as follows:
- Eliquis (generic name: apixaban), used to prevent and treat serious blood clots. It is taken by about 3.7 million people through Part D plans. The estimated cost is $16.4 billion.
- Jardiance (generic name: empagliflozin), used for diabetes and heart failure. It is taken by almost 1.6 million people through Part D plans. The estimated cost is $7.06 billion.
- Xarelto (generic name: rivaroxaban), used for blood clots. It is taken by about 1.3 million people through Part D plans. The estimated cost is $6 billion.
- Januvia (generic name: sitagliptin), used for diabetes. It is taken by about 869,00 people through Part D plans. The estimated cost is $4.1 billion.
- Farxiga (generic name: dapagliflozin), used for diabetes, heart failure, and chronic kidney disease. It is taken by about 799,000 people through Part D plans. The estimated cost is almost $3.3 billion.
- Entresto (generic name: sacubitril/valsartan), used to treat heart failure. It is taken by 587,000 people through Part D plans. The estimated cost is $2.9 billion.
- Enbrel( generic name: etanercept), used for rheumatoid arthritis, psoriasis, and psoriatic arthritis. It is taken by 48,000 people through Part D plans. The estimated cost is $2.8 billion.
- Imbruvica (generic name: ibrutinib), used to treat some blood cancers. It is taken by about 20,000 people in Part D plans. The estimated cost is $2.7 billion.
- Stelara (generic name: ustekinumab), used to treat plaque psoriasis, psoriatic arthritis, or certain bowel conditions (Crohn’s disease, ulcerative colitis). It is used by about 22,000 people through Part D plans. The estimated cost is $2.6 billion.
- Fiasp; Fiasp FlexTouch; Fiasp PenFill; NovoLog; NovoLog FlexPen; NovoLog PenFill. These are forms of insulin used to treat diabetes. They are used by about 777,000 people through Part D plans. The estimated cost is $2.6 billion.
A vocal critic of Medicare drug negotiations, Joel White, president of the Council for Affordable Health Coverage, called the announcement of the 10 drugs selected for negotiation “a hollow victory lap.” A former Republican staffer on the House Ways and Means Committee, Mr. White aided with the development of the Medicare Part D plans and has kept tabs on the pharmacy programs since its launch in 2006.
“No one’s costs will go down now or for years because of this announcement” about Part D negotiations, Mr. White said in a statement.
According to its website, CAHC includes among its members the American Academy of Ophthalmology as well as some patient groups, drugmakers, such as Johnson & Johnson, and insurers and industry groups, such as the National Association of Manufacturers.
Separately, the influential Chamber of Commerce is making a strong push to at least delay the implementation of the Medicare Part D drug negotiations. On Aug. 28, the chamber released a letter sent to the Biden administration, raising concerns about a “rush” to implement the provisions of the Inflation Reduction Act.
The chamber also has filed suit to challenge the drug negotiation provisions of the Inflation Reduction Act, requesting that the court issue a preliminary injunction by Oct. 1, 2023.
Other pending legal challenges to direct Medicare drug negotiations include suits filed by Merck, Bristol-Myers Squibb, Johnson & Johnson, Boehringer Ingelheim, and AstraZeneca, according to an email from Pharmaceutical Research and Manufacturers of America. PhRMA also said it is a party to a case.
In addition, the three congressional Republicans with most direct influence over Medicare policy issued on Aug. 29 a joint statement outlining their objections to the planned negotiations on drug prices.
This drug-negotiation proposal is “an unworkable, legally dubious scheme that will lead to higher prices for new drugs coming to market, stifle the development of new cures, and destroy jobs,” said House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-Wash.), House Ways and Means Committee Chair Jason Smith (R-Mo.), and Senate Finance Committee Ranking Member Mike Crapo (R-Idaho).
Democrats were equally firm and vocal in their support of the negotiations. Senate Finance Chairman Ron Wyden (D-Ore.) issued a statement on Aug. 29 that said the release of the list of the 10 drugs selected for Medicare drug negotiations is part of a “seismic shift in the relationship between Big Pharma, the federal government, and seniors who are counting on lower prices.
“I will be following the negotiation process closely and will fight any attempt by Big Pharma to undo or undermine the progress that’s been made,” Mr. Wyden said.
In addition, AARP issued a statement of its continued support for Medicare drug negotiations.
“The No. 1 reason seniors skip or ration their prescriptions is because they can’t afford them. This must stop,” said AARP executive vice president and chief advocacy and engagement officer Nancy LeaMond in the statement. “The big drug companies and their allies continue suing to overturn the Medicare drug price negotiation program to keep up their price gouging. We can’t allow seniors to be Big Pharma’s cash machine anymore.”
A version of this article first appeared on Medscape.com.
People on Medicare may in 2026 see prices drop for 10 medicines, including pricey diabetes, cancer, blood clot, and arthritis treatments, if advocates for federal drug-price negotiations can implement their plans amid tough opposition.
It’s unclear at this time, though, how these negotiations will play out. The Chamber of Commerce has sided with pharmaceutical companies in bids to block direct Medicare negotiation of drug prices. Many influential Republicans in Congress oppose this plan, which has deep support from both Democrats and AARP.
While facing strong opposition to negotiations, the Centers for Medicare & Medicaid Services sought in its announcement to illustrate the high costs of the selected medicines.
CMS provided data on total Part D costs for selected medicines for the period from June 2022 to May 2023, along with tallies of the number of people taking these drugs. The 10 selected medicines are as follows:
- Eliquis (generic name: apixaban), used to prevent and treat serious blood clots. It is taken by about 3.7 million people through Part D plans. The estimated cost is $16.4 billion.
- Jardiance (generic name: empagliflozin), used for diabetes and heart failure. It is taken by almost 1.6 million people through Part D plans. The estimated cost is $7.06 billion.
- Xarelto (generic name: rivaroxaban), used for blood clots. It is taken by about 1.3 million people through Part D plans. The estimated cost is $6 billion.
- Januvia (generic name: sitagliptin), used for diabetes. It is taken by about 869,00 people through Part D plans. The estimated cost is $4.1 billion.
- Farxiga (generic name: dapagliflozin), used for diabetes, heart failure, and chronic kidney disease. It is taken by about 799,000 people through Part D plans. The estimated cost is almost $3.3 billion.
- Entresto (generic name: sacubitril/valsartan), used to treat heart failure. It is taken by 587,000 people through Part D plans. The estimated cost is $2.9 billion.
- Enbrel( generic name: etanercept), used for rheumatoid arthritis, psoriasis, and psoriatic arthritis. It is taken by 48,000 people through Part D plans. The estimated cost is $2.8 billion.
- Imbruvica (generic name: ibrutinib), used to treat some blood cancers. It is taken by about 20,000 people in Part D plans. The estimated cost is $2.7 billion.
- Stelara (generic name: ustekinumab), used to treat plaque psoriasis, psoriatic arthritis, or certain bowel conditions (Crohn’s disease, ulcerative colitis). It is used by about 22,000 people through Part D plans. The estimated cost is $2.6 billion.
- Fiasp; Fiasp FlexTouch; Fiasp PenFill; NovoLog; NovoLog FlexPen; NovoLog PenFill. These are forms of insulin used to treat diabetes. They are used by about 777,000 people through Part D plans. The estimated cost is $2.6 billion.
A vocal critic of Medicare drug negotiations, Joel White, president of the Council for Affordable Health Coverage, called the announcement of the 10 drugs selected for negotiation “a hollow victory lap.” A former Republican staffer on the House Ways and Means Committee, Mr. White aided with the development of the Medicare Part D plans and has kept tabs on the pharmacy programs since its launch in 2006.
“No one’s costs will go down now or for years because of this announcement” about Part D negotiations, Mr. White said in a statement.
According to its website, CAHC includes among its members the American Academy of Ophthalmology as well as some patient groups, drugmakers, such as Johnson & Johnson, and insurers and industry groups, such as the National Association of Manufacturers.
Separately, the influential Chamber of Commerce is making a strong push to at least delay the implementation of the Medicare Part D drug negotiations. On Aug. 28, the chamber released a letter sent to the Biden administration, raising concerns about a “rush” to implement the provisions of the Inflation Reduction Act.
The chamber also has filed suit to challenge the drug negotiation provisions of the Inflation Reduction Act, requesting that the court issue a preliminary injunction by Oct. 1, 2023.
Other pending legal challenges to direct Medicare drug negotiations include suits filed by Merck, Bristol-Myers Squibb, Johnson & Johnson, Boehringer Ingelheim, and AstraZeneca, according to an email from Pharmaceutical Research and Manufacturers of America. PhRMA also said it is a party to a case.
In addition, the three congressional Republicans with most direct influence over Medicare policy issued on Aug. 29 a joint statement outlining their objections to the planned negotiations on drug prices.
This drug-negotiation proposal is “an unworkable, legally dubious scheme that will lead to higher prices for new drugs coming to market, stifle the development of new cures, and destroy jobs,” said House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-Wash.), House Ways and Means Committee Chair Jason Smith (R-Mo.), and Senate Finance Committee Ranking Member Mike Crapo (R-Idaho).
Democrats were equally firm and vocal in their support of the negotiations. Senate Finance Chairman Ron Wyden (D-Ore.) issued a statement on Aug. 29 that said the release of the list of the 10 drugs selected for Medicare drug negotiations is part of a “seismic shift in the relationship between Big Pharma, the federal government, and seniors who are counting on lower prices.
“I will be following the negotiation process closely and will fight any attempt by Big Pharma to undo or undermine the progress that’s been made,” Mr. Wyden said.
In addition, AARP issued a statement of its continued support for Medicare drug negotiations.
“The No. 1 reason seniors skip or ration their prescriptions is because they can’t afford them. This must stop,” said AARP executive vice president and chief advocacy and engagement officer Nancy LeaMond in the statement. “The big drug companies and their allies continue suing to overturn the Medicare drug price negotiation program to keep up their price gouging. We can’t allow seniors to be Big Pharma’s cash machine anymore.”
A version of this article first appeared on Medscape.com.
Rheumatology trials seem vulnerable to unblinding: Report
Until more is known about the potential for unblinding, clinicians need to keep in mind that patients and physicians could often guess accurately who was getting placebo or active drug, first author Cody Bruggemeyer, MD, a resident at the Medical College of Wisconsin, Milwaukee, said in an interview.
“It’s important that rheumatologists be aware of this potential issue and use their clinical reasoning and their ability to critically assess papers to evaluate the study design” of research on treatments, he said in an interview.
Dr. Bruggemeyer and coauthors at the Medical College of Wisconsin presented their assessment of the potential for unblinding in a Viewpoint article in The Lancet Rheumatology.
A sample of pivotal clinical trials
The authors selected a sample of pivotal studies of 14 commonly prescribed drugs for rheumatic conditions for which double-blind randomized controlled trials (RCTs) that compared the active ingredient with a placebo were available.
The 14 trials involved treatments classified as disease-modifying antirheumatic drugs (DMARDs), some of which were likely to produce side effects that placebos would not mimic, such as injection site and infusion reactions and difference in readings in lab reports, the authors wrote.
In their analysis, Dr. Bruggemeyer and colleagues evaluated discrepancies in the rates of adverse events reported between active drugs and placebos and classified the 14 studies as follows:
- High unblinding risk: Nine studies had a high estimated risk of unblinding, including trials of adalimumab with citrate (Humira), anakinra (Kineret), anifrolumab (Saphnelo), apremilast (Otezla), ixekizumab (Taltz), leflunomide (Arava), methotrexate, risankizumab (Skyrizi) and tofacitinib (Xeljanz).
- Moderate unblinding risk: Three studies had a moderate estimated risk of unblinding, including trials of azathioprine (Imuran), mycophenolate mofetil and tocilizumab (Actemra).
- Low unblinding risk: Two studies had a low estimated risk of unblinding. These involved tests of belimumab (Benlysta) and rituximab (Rituxan).
Many of the effectiveness measurements of treatments used in rheumatology depend on patients’ reports of relief of pain and other disease symptoms. For example, the widely used American College of Rheumatology 20% response for rheumatoid arthritis includes components that rely on patient and physician assessment of disease activity.
Unblinding risk to clinical trial validity
CTs are the highest level of evidence to establish efficacy, because the study design aims to mask whether the experimental treatment is a drug or placebo. In cases where patients and physicians are more likely to correctly detect use of an active drug, there can be biases that skew results toward reports of symptom improvement. Other patients’ views of their treatment may be distorted by accurate guesses that they have been given placebo, Dr. Bruggemeyer and coauthors wrote.
“The degree of these effects cannot be predicted, but they tend to erroneously inflate the perceived benefit of novel interventions,” they wrote.
The consequences of this unblinding may be minimal in cases where there’s a clear difference between the placebo and active drug, they said. As an example, they cited trials of interleukin-23 inhibitors for psoriasis, where skin clearance as measured by the Psoriatic Area and Severity Index 75 differed by more than 50% in absolute terms between the treatment and placebo groups.
But in other cases, there needs to be more attention paid to the potential role of unblinding, they wrote.
“Studies where effect sizes were small, contradictory, or dependent on subgroup analyses might be especially problematic, but commentary rarely reflects this issue or acknowledges the potential influence of unblinding,” they wrote.
In the paper, they call for more analysis of previous trials to look for unreported assessments of unblinding, while also asking that researchers consider surveying participants in future trials to evaluate the degree to which unblinding occurs.
“Advocacy from professional societies and the U.S. Food and Drug Administration itself might be necessary, but in the interim, rheumatologists should assume unblinding has occurred to some degree in most trials,” they wrote.
Unblinding measure needs validation
In an interview, Roy M. Fleischmann, MD, co–medical director of the Metroplex Clinical Research Center in Dallas, raised some objections to the paper. The paper addresses an interesting question about unblinding, but there should have been more work done, such as finding “a measure that is validated that can say whether you’ve been unblinded or not.”
He added that he was surprised the paper on unblinding in rheumatology trials was published in its current form.
“I would have sent it for a major rewrite” if asked to review this paper before publication, said Dr. Fleischmann, who as a reviewer for Lancet Rheumatology. “I would have said: ‘Okay, 90% of this paper is okay, but your gist is not correct.’ It should be: ‘Is this a problem?’ ”
Dr. Fleischmann said he would have recommended a different perspective to the paper. “That is, this could occur. Should we be looking at this, and how would we look at this?”
In the paper, the authors acknowledge their approach has not been validated, “but it highlights the potential effect of idiosyncratic adverse events,” they wrote.
There’s less funding in general for meta-research than for studies involving treatments, so researchers look for approaches that can be handled without requiring significant funding, and much of the research on the quality of research is conducted like this analysis of rheumatology trials, Michael Putman, MD, the corresponding author and is a rheumatologist and an assistant professor at the Medical College of Wisconsin, said in an interview.
“You’re mostly doing on a shoestring budget with yourself and trainees,” he said. Dr. Putman is an associate editor at the journal Rheumatology and also involved in meta-research, or efforts to understand how studies and trials answer questions about how medical treatments work.
In an Aug. 16 tweet, Dr. Putman said this issue of unintentional unblinding with rheumatology trials was something he’d “been ruminating about for awhile; took two all star trainees to push it over the top!”
One of the barriers to funding of meta-research is a tendency for major funding for medical studies to be focused on specific diseases or targets. With meta-research, it may be more difficult to explain how a specific project will advance efforts to treat or prevent a certain disease, Dr. Putman said.
“It’s a little more esoteric and maybe not quite as clear how these projects will move things forward,” Dr. Putman said.
In addition, the nature of meta-research is to question and often be critical of work that’s already been published, adding another hurdle in attempts to secure funding, he said.
Dr. Putman is supported by a Rheumatology Research Foundation Scientist Development Grant, receives research funding related to clinical trials by AbbVie and AstraZeneca, and consulting fees from Novartis. The other authors declared no competing interests.
Until more is known about the potential for unblinding, clinicians need to keep in mind that patients and physicians could often guess accurately who was getting placebo or active drug, first author Cody Bruggemeyer, MD, a resident at the Medical College of Wisconsin, Milwaukee, said in an interview.
“It’s important that rheumatologists be aware of this potential issue and use their clinical reasoning and their ability to critically assess papers to evaluate the study design” of research on treatments, he said in an interview.
Dr. Bruggemeyer and coauthors at the Medical College of Wisconsin presented their assessment of the potential for unblinding in a Viewpoint article in The Lancet Rheumatology.
A sample of pivotal clinical trials
The authors selected a sample of pivotal studies of 14 commonly prescribed drugs for rheumatic conditions for which double-blind randomized controlled trials (RCTs) that compared the active ingredient with a placebo were available.
The 14 trials involved treatments classified as disease-modifying antirheumatic drugs (DMARDs), some of which were likely to produce side effects that placebos would not mimic, such as injection site and infusion reactions and difference in readings in lab reports, the authors wrote.
In their analysis, Dr. Bruggemeyer and colleagues evaluated discrepancies in the rates of adverse events reported between active drugs and placebos and classified the 14 studies as follows:
- High unblinding risk: Nine studies had a high estimated risk of unblinding, including trials of adalimumab with citrate (Humira), anakinra (Kineret), anifrolumab (Saphnelo), apremilast (Otezla), ixekizumab (Taltz), leflunomide (Arava), methotrexate, risankizumab (Skyrizi) and tofacitinib (Xeljanz).
- Moderate unblinding risk: Three studies had a moderate estimated risk of unblinding, including trials of azathioprine (Imuran), mycophenolate mofetil and tocilizumab (Actemra).
- Low unblinding risk: Two studies had a low estimated risk of unblinding. These involved tests of belimumab (Benlysta) and rituximab (Rituxan).
Many of the effectiveness measurements of treatments used in rheumatology depend on patients’ reports of relief of pain and other disease symptoms. For example, the widely used American College of Rheumatology 20% response for rheumatoid arthritis includes components that rely on patient and physician assessment of disease activity.
Unblinding risk to clinical trial validity
CTs are the highest level of evidence to establish efficacy, because the study design aims to mask whether the experimental treatment is a drug or placebo. In cases where patients and physicians are more likely to correctly detect use of an active drug, there can be biases that skew results toward reports of symptom improvement. Other patients’ views of their treatment may be distorted by accurate guesses that they have been given placebo, Dr. Bruggemeyer and coauthors wrote.
“The degree of these effects cannot be predicted, but they tend to erroneously inflate the perceived benefit of novel interventions,” they wrote.
The consequences of this unblinding may be minimal in cases where there’s a clear difference between the placebo and active drug, they said. As an example, they cited trials of interleukin-23 inhibitors for psoriasis, where skin clearance as measured by the Psoriatic Area and Severity Index 75 differed by more than 50% in absolute terms between the treatment and placebo groups.
But in other cases, there needs to be more attention paid to the potential role of unblinding, they wrote.
“Studies where effect sizes were small, contradictory, or dependent on subgroup analyses might be especially problematic, but commentary rarely reflects this issue or acknowledges the potential influence of unblinding,” they wrote.
In the paper, they call for more analysis of previous trials to look for unreported assessments of unblinding, while also asking that researchers consider surveying participants in future trials to evaluate the degree to which unblinding occurs.
“Advocacy from professional societies and the U.S. Food and Drug Administration itself might be necessary, but in the interim, rheumatologists should assume unblinding has occurred to some degree in most trials,” they wrote.
Unblinding measure needs validation
In an interview, Roy M. Fleischmann, MD, co–medical director of the Metroplex Clinical Research Center in Dallas, raised some objections to the paper. The paper addresses an interesting question about unblinding, but there should have been more work done, such as finding “a measure that is validated that can say whether you’ve been unblinded or not.”
He added that he was surprised the paper on unblinding in rheumatology trials was published in its current form.
“I would have sent it for a major rewrite” if asked to review this paper before publication, said Dr. Fleischmann, who as a reviewer for Lancet Rheumatology. “I would have said: ‘Okay, 90% of this paper is okay, but your gist is not correct.’ It should be: ‘Is this a problem?’ ”
Dr. Fleischmann said he would have recommended a different perspective to the paper. “That is, this could occur. Should we be looking at this, and how would we look at this?”
In the paper, the authors acknowledge their approach has not been validated, “but it highlights the potential effect of idiosyncratic adverse events,” they wrote.
There’s less funding in general for meta-research than for studies involving treatments, so researchers look for approaches that can be handled without requiring significant funding, and much of the research on the quality of research is conducted like this analysis of rheumatology trials, Michael Putman, MD, the corresponding author and is a rheumatologist and an assistant professor at the Medical College of Wisconsin, said in an interview.
“You’re mostly doing on a shoestring budget with yourself and trainees,” he said. Dr. Putman is an associate editor at the journal Rheumatology and also involved in meta-research, or efforts to understand how studies and trials answer questions about how medical treatments work.
In an Aug. 16 tweet, Dr. Putman said this issue of unintentional unblinding with rheumatology trials was something he’d “been ruminating about for awhile; took two all star trainees to push it over the top!”
One of the barriers to funding of meta-research is a tendency for major funding for medical studies to be focused on specific diseases or targets. With meta-research, it may be more difficult to explain how a specific project will advance efforts to treat or prevent a certain disease, Dr. Putman said.
“It’s a little more esoteric and maybe not quite as clear how these projects will move things forward,” Dr. Putman said.
In addition, the nature of meta-research is to question and often be critical of work that’s already been published, adding another hurdle in attempts to secure funding, he said.
Dr. Putman is supported by a Rheumatology Research Foundation Scientist Development Grant, receives research funding related to clinical trials by AbbVie and AstraZeneca, and consulting fees from Novartis. The other authors declared no competing interests.
Until more is known about the potential for unblinding, clinicians need to keep in mind that patients and physicians could often guess accurately who was getting placebo or active drug, first author Cody Bruggemeyer, MD, a resident at the Medical College of Wisconsin, Milwaukee, said in an interview.
“It’s important that rheumatologists be aware of this potential issue and use their clinical reasoning and their ability to critically assess papers to evaluate the study design” of research on treatments, he said in an interview.
Dr. Bruggemeyer and coauthors at the Medical College of Wisconsin presented their assessment of the potential for unblinding in a Viewpoint article in The Lancet Rheumatology.
A sample of pivotal clinical trials
The authors selected a sample of pivotal studies of 14 commonly prescribed drugs for rheumatic conditions for which double-blind randomized controlled trials (RCTs) that compared the active ingredient with a placebo were available.
The 14 trials involved treatments classified as disease-modifying antirheumatic drugs (DMARDs), some of which were likely to produce side effects that placebos would not mimic, such as injection site and infusion reactions and difference in readings in lab reports, the authors wrote.
In their analysis, Dr. Bruggemeyer and colleagues evaluated discrepancies in the rates of adverse events reported between active drugs and placebos and classified the 14 studies as follows:
- High unblinding risk: Nine studies had a high estimated risk of unblinding, including trials of adalimumab with citrate (Humira), anakinra (Kineret), anifrolumab (Saphnelo), apremilast (Otezla), ixekizumab (Taltz), leflunomide (Arava), methotrexate, risankizumab (Skyrizi) and tofacitinib (Xeljanz).
- Moderate unblinding risk: Three studies had a moderate estimated risk of unblinding, including trials of azathioprine (Imuran), mycophenolate mofetil and tocilizumab (Actemra).
- Low unblinding risk: Two studies had a low estimated risk of unblinding. These involved tests of belimumab (Benlysta) and rituximab (Rituxan).
Many of the effectiveness measurements of treatments used in rheumatology depend on patients’ reports of relief of pain and other disease symptoms. For example, the widely used American College of Rheumatology 20% response for rheumatoid arthritis includes components that rely on patient and physician assessment of disease activity.
Unblinding risk to clinical trial validity
CTs are the highest level of evidence to establish efficacy, because the study design aims to mask whether the experimental treatment is a drug or placebo. In cases where patients and physicians are more likely to correctly detect use of an active drug, there can be biases that skew results toward reports of symptom improvement. Other patients’ views of their treatment may be distorted by accurate guesses that they have been given placebo, Dr. Bruggemeyer and coauthors wrote.
“The degree of these effects cannot be predicted, but they tend to erroneously inflate the perceived benefit of novel interventions,” they wrote.
The consequences of this unblinding may be minimal in cases where there’s a clear difference between the placebo and active drug, they said. As an example, they cited trials of interleukin-23 inhibitors for psoriasis, where skin clearance as measured by the Psoriatic Area and Severity Index 75 differed by more than 50% in absolute terms between the treatment and placebo groups.
But in other cases, there needs to be more attention paid to the potential role of unblinding, they wrote.
“Studies where effect sizes were small, contradictory, or dependent on subgroup analyses might be especially problematic, but commentary rarely reflects this issue or acknowledges the potential influence of unblinding,” they wrote.
In the paper, they call for more analysis of previous trials to look for unreported assessments of unblinding, while also asking that researchers consider surveying participants in future trials to evaluate the degree to which unblinding occurs.
“Advocacy from professional societies and the U.S. Food and Drug Administration itself might be necessary, but in the interim, rheumatologists should assume unblinding has occurred to some degree in most trials,” they wrote.
Unblinding measure needs validation
In an interview, Roy M. Fleischmann, MD, co–medical director of the Metroplex Clinical Research Center in Dallas, raised some objections to the paper. The paper addresses an interesting question about unblinding, but there should have been more work done, such as finding “a measure that is validated that can say whether you’ve been unblinded or not.”
He added that he was surprised the paper on unblinding in rheumatology trials was published in its current form.
“I would have sent it for a major rewrite” if asked to review this paper before publication, said Dr. Fleischmann, who as a reviewer for Lancet Rheumatology. “I would have said: ‘Okay, 90% of this paper is okay, but your gist is not correct.’ It should be: ‘Is this a problem?’ ”
Dr. Fleischmann said he would have recommended a different perspective to the paper. “That is, this could occur. Should we be looking at this, and how would we look at this?”
In the paper, the authors acknowledge their approach has not been validated, “but it highlights the potential effect of idiosyncratic adverse events,” they wrote.
There’s less funding in general for meta-research than for studies involving treatments, so researchers look for approaches that can be handled without requiring significant funding, and much of the research on the quality of research is conducted like this analysis of rheumatology trials, Michael Putman, MD, the corresponding author and is a rheumatologist and an assistant professor at the Medical College of Wisconsin, said in an interview.
“You’re mostly doing on a shoestring budget with yourself and trainees,” he said. Dr. Putman is an associate editor at the journal Rheumatology and also involved in meta-research, or efforts to understand how studies and trials answer questions about how medical treatments work.
In an Aug. 16 tweet, Dr. Putman said this issue of unintentional unblinding with rheumatology trials was something he’d “been ruminating about for awhile; took two all star trainees to push it over the top!”
One of the barriers to funding of meta-research is a tendency for major funding for medical studies to be focused on specific diseases or targets. With meta-research, it may be more difficult to explain how a specific project will advance efforts to treat or prevent a certain disease, Dr. Putman said.
“It’s a little more esoteric and maybe not quite as clear how these projects will move things forward,” Dr. Putman said.
In addition, the nature of meta-research is to question and often be critical of work that’s already been published, adding another hurdle in attempts to secure funding, he said.
Dr. Putman is supported by a Rheumatology Research Foundation Scientist Development Grant, receives research funding related to clinical trials by AbbVie and AstraZeneca, and consulting fees from Novartis. The other authors declared no competing interests.
FROM THE LANCET RHEUMATOLOGY
National Practitioner Data Bank should go public, group says
arguing that extra public scrutiny could pressure state medical boards to be more aggressive watchdogs.
Public Citizen’s report includes an analysis of how frequently medical boards sanctioned physicians in 2019, 2020, and 2021. These sanctions include license revocations, suspensions, voluntary surrenders of licenses, and limitations on practice while under investigation.
The report used data from the National Practitioner Data Bank (NPDB), a federal repository of reports about state licensure, discipline, and certification actions as well as medical malpractice payments. The database is closed to the public, but hospitals, malpractice insurers, and investigators can query it.
According to Public Citizen’s calculations, states most likely to take serious disciplinary action against physicians were:
- Michigan: 1.74 serious disciplinary actions per 1,000 physicians per year
- Ohio: 1.61
- North Dakota: 1.60
- Colorado: 1.55
- Arizona: 1.53
- The states least likely to do so were:
- Nevada: 0.24 serious disciplinary actions per 1,000 physicians per year
- New Hampshire: 0.25
- Georgia: 0.27
- Indiana: 0.28
- Nebraska: 0.32
- California, the largest U.S. state by both population and number of physicians, landed near the middle, ranking 27th with a rate of 0.83 serious actions per 1,000 physicians, Public Citizen said.
“There is no evidence that physicians in any state are, overall, more or less likely to be incompetent or miscreant than the physicians in any other state,” said Robert Oshel, PhD, a former NPDB associate director for research and an author of the report.
The differences instead reflect variations in boards’ enforcement of medical practice laws, domination of licensing boards by physicians, and inadequate budgets, he noted.
Public Citizen said Congress should change federal law to let members of the public get information from the NPDB to do a background check on physicians whom they are considering seeing or are already seeing. This would not only help individuals but also would spur state licensing boards to do their own checks with the NPDB, the group said.
“If licensing boards routinely queried the NPDB, they would not be faulted by the public and state legislators for not knowing about malpractice payments or disciplinary actions affecting their licensees and therefore not taking reasonable actions concerning their licensees found to have poor records,” the report said.
Questioning NPDB access for consumers
Michelle Mello, JD, PhD, a professor of law and health policy at Stanford (Calif.) University, has studied the current applications of the NPDB. In 2019, she published an article in The New England Journal of Medicine examining changes in practice patterns for clinicians who faced multiple malpractice claims.
Dr. Mello questioned what benefit consumers would get from direct access to the NPDB’s information.
“It provides almost no context for the information it reports, making it even harder for patients to make sense of what they see there,” Dr. Mello said in an interview.
Hospitals are already required to routinely query the NPDB. This legal requirement should be expanded to include licensing boards, which the report called “the last line of defense for the public from incompetent and miscreant physicians,” Public Citizen said.
“Ideally, this amendment should include free continuous query access by medical boards for all their licensees,” the report said. “In the absence of any action by Congress, individual state legislatures should require their licensing boards to query all their licensees or enroll in continuous query, as a few states already do.”
The Federation of State Medical Boards agreed with some of the other suggestions Public Citizen offered in the report. The two concur on the need for increased funding to state medical boards to ensure that they have adequate resources and staffing to fulfill their duties, FSMB said in a statement.
But FSMB disagreed with Public Citizens’ approach to ranking boards, saying it could mislead. The report lacks context about how boards’ funding and authority vary, Humayun Chaudhry, DO, FSMB’s chief executive officer, said. He also questioned the decision to focus only on serious disciplinary actions.
“The Public Citizen report does not take into account the wide range of disciplinary steps boards can take such as letters of reprimand or fines, which are often enough to stop problem behaviors – preempting further problems in the future,” Dr. Chaudhry said.
D.C. gets worst rating
The District of Columbia earned the worst mark in the Public Citizen ranking, holding the 51st spot, the same place it held in the group’s similar ranking on actions taken in the 2017-2019 period. There were 0.19 serious disciplinary actions per 1,000 physicians a year in Washington, Public Citizen said.
In an email to this news organization, Dr. Oshel said that the Public Citizen analysis focused on the number of licensed physicians in each state and D.C. that can be obtained and compared reliably. It avoided using the term “practicing physicians” owing in part to doubts about the reliability of these counts, he said.
As many as 20% of physicians nationwide are focused primarily on work outside of clinical care, Dr. Oshel estimated. In D.C., perhaps 40% of physicians may fall into this category. Of the more than 13,700 physicians licensed in D.C., there may be only about 8,126 actively practicing, according to Dr. Oshel.
But even using that lower estimate of practicing physicians would only raise D.C.’s ranking to 46, signaling a need for stepped-up enforcement, Dr. Oshel said.
“[Whether it’s] 46th or 51st, both are bad,” Dr. Oshel said.
A version of this article first appeared on Medscape.com.
arguing that extra public scrutiny could pressure state medical boards to be more aggressive watchdogs.
Public Citizen’s report includes an analysis of how frequently medical boards sanctioned physicians in 2019, 2020, and 2021. These sanctions include license revocations, suspensions, voluntary surrenders of licenses, and limitations on practice while under investigation.
The report used data from the National Practitioner Data Bank (NPDB), a federal repository of reports about state licensure, discipline, and certification actions as well as medical malpractice payments. The database is closed to the public, but hospitals, malpractice insurers, and investigators can query it.
According to Public Citizen’s calculations, states most likely to take serious disciplinary action against physicians were:
- Michigan: 1.74 serious disciplinary actions per 1,000 physicians per year
- Ohio: 1.61
- North Dakota: 1.60
- Colorado: 1.55
- Arizona: 1.53
- The states least likely to do so were:
- Nevada: 0.24 serious disciplinary actions per 1,000 physicians per year
- New Hampshire: 0.25
- Georgia: 0.27
- Indiana: 0.28
- Nebraska: 0.32
- California, the largest U.S. state by both population and number of physicians, landed near the middle, ranking 27th with a rate of 0.83 serious actions per 1,000 physicians, Public Citizen said.
“There is no evidence that physicians in any state are, overall, more or less likely to be incompetent or miscreant than the physicians in any other state,” said Robert Oshel, PhD, a former NPDB associate director for research and an author of the report.
The differences instead reflect variations in boards’ enforcement of medical practice laws, domination of licensing boards by physicians, and inadequate budgets, he noted.
Public Citizen said Congress should change federal law to let members of the public get information from the NPDB to do a background check on physicians whom they are considering seeing or are already seeing. This would not only help individuals but also would spur state licensing boards to do their own checks with the NPDB, the group said.
“If licensing boards routinely queried the NPDB, they would not be faulted by the public and state legislators for not knowing about malpractice payments or disciplinary actions affecting their licensees and therefore not taking reasonable actions concerning their licensees found to have poor records,” the report said.
Questioning NPDB access for consumers
Michelle Mello, JD, PhD, a professor of law and health policy at Stanford (Calif.) University, has studied the current applications of the NPDB. In 2019, she published an article in The New England Journal of Medicine examining changes in practice patterns for clinicians who faced multiple malpractice claims.
Dr. Mello questioned what benefit consumers would get from direct access to the NPDB’s information.
“It provides almost no context for the information it reports, making it even harder for patients to make sense of what they see there,” Dr. Mello said in an interview.
Hospitals are already required to routinely query the NPDB. This legal requirement should be expanded to include licensing boards, which the report called “the last line of defense for the public from incompetent and miscreant physicians,” Public Citizen said.
“Ideally, this amendment should include free continuous query access by medical boards for all their licensees,” the report said. “In the absence of any action by Congress, individual state legislatures should require their licensing boards to query all their licensees or enroll in continuous query, as a few states already do.”
The Federation of State Medical Boards agreed with some of the other suggestions Public Citizen offered in the report. The two concur on the need for increased funding to state medical boards to ensure that they have adequate resources and staffing to fulfill their duties, FSMB said in a statement.
But FSMB disagreed with Public Citizens’ approach to ranking boards, saying it could mislead. The report lacks context about how boards’ funding and authority vary, Humayun Chaudhry, DO, FSMB’s chief executive officer, said. He also questioned the decision to focus only on serious disciplinary actions.
“The Public Citizen report does not take into account the wide range of disciplinary steps boards can take such as letters of reprimand or fines, which are often enough to stop problem behaviors – preempting further problems in the future,” Dr. Chaudhry said.
D.C. gets worst rating
The District of Columbia earned the worst mark in the Public Citizen ranking, holding the 51st spot, the same place it held in the group’s similar ranking on actions taken in the 2017-2019 period. There were 0.19 serious disciplinary actions per 1,000 physicians a year in Washington, Public Citizen said.
In an email to this news organization, Dr. Oshel said that the Public Citizen analysis focused on the number of licensed physicians in each state and D.C. that can be obtained and compared reliably. It avoided using the term “practicing physicians” owing in part to doubts about the reliability of these counts, he said.
As many as 20% of physicians nationwide are focused primarily on work outside of clinical care, Dr. Oshel estimated. In D.C., perhaps 40% of physicians may fall into this category. Of the more than 13,700 physicians licensed in D.C., there may be only about 8,126 actively practicing, according to Dr. Oshel.
But even using that lower estimate of practicing physicians would only raise D.C.’s ranking to 46, signaling a need for stepped-up enforcement, Dr. Oshel said.
“[Whether it’s] 46th or 51st, both are bad,” Dr. Oshel said.
A version of this article first appeared on Medscape.com.
arguing that extra public scrutiny could pressure state medical boards to be more aggressive watchdogs.
Public Citizen’s report includes an analysis of how frequently medical boards sanctioned physicians in 2019, 2020, and 2021. These sanctions include license revocations, suspensions, voluntary surrenders of licenses, and limitations on practice while under investigation.
The report used data from the National Practitioner Data Bank (NPDB), a federal repository of reports about state licensure, discipline, and certification actions as well as medical malpractice payments. The database is closed to the public, but hospitals, malpractice insurers, and investigators can query it.
According to Public Citizen’s calculations, states most likely to take serious disciplinary action against physicians were:
- Michigan: 1.74 serious disciplinary actions per 1,000 physicians per year
- Ohio: 1.61
- North Dakota: 1.60
- Colorado: 1.55
- Arizona: 1.53
- The states least likely to do so were:
- Nevada: 0.24 serious disciplinary actions per 1,000 physicians per year
- New Hampshire: 0.25
- Georgia: 0.27
- Indiana: 0.28
- Nebraska: 0.32
- California, the largest U.S. state by both population and number of physicians, landed near the middle, ranking 27th with a rate of 0.83 serious actions per 1,000 physicians, Public Citizen said.
“There is no evidence that physicians in any state are, overall, more or less likely to be incompetent or miscreant than the physicians in any other state,” said Robert Oshel, PhD, a former NPDB associate director for research and an author of the report.
The differences instead reflect variations in boards’ enforcement of medical practice laws, domination of licensing boards by physicians, and inadequate budgets, he noted.
Public Citizen said Congress should change federal law to let members of the public get information from the NPDB to do a background check on physicians whom they are considering seeing or are already seeing. This would not only help individuals but also would spur state licensing boards to do their own checks with the NPDB, the group said.
“If licensing boards routinely queried the NPDB, they would not be faulted by the public and state legislators for not knowing about malpractice payments or disciplinary actions affecting their licensees and therefore not taking reasonable actions concerning their licensees found to have poor records,” the report said.
Questioning NPDB access for consumers
Michelle Mello, JD, PhD, a professor of law and health policy at Stanford (Calif.) University, has studied the current applications of the NPDB. In 2019, she published an article in The New England Journal of Medicine examining changes in practice patterns for clinicians who faced multiple malpractice claims.
Dr. Mello questioned what benefit consumers would get from direct access to the NPDB’s information.
“It provides almost no context for the information it reports, making it even harder for patients to make sense of what they see there,” Dr. Mello said in an interview.
Hospitals are already required to routinely query the NPDB. This legal requirement should be expanded to include licensing boards, which the report called “the last line of defense for the public from incompetent and miscreant physicians,” Public Citizen said.
“Ideally, this amendment should include free continuous query access by medical boards for all their licensees,” the report said. “In the absence of any action by Congress, individual state legislatures should require their licensing boards to query all their licensees or enroll in continuous query, as a few states already do.”
The Federation of State Medical Boards agreed with some of the other suggestions Public Citizen offered in the report. The two concur on the need for increased funding to state medical boards to ensure that they have adequate resources and staffing to fulfill their duties, FSMB said in a statement.
But FSMB disagreed with Public Citizens’ approach to ranking boards, saying it could mislead. The report lacks context about how boards’ funding and authority vary, Humayun Chaudhry, DO, FSMB’s chief executive officer, said. He also questioned the decision to focus only on serious disciplinary actions.
“The Public Citizen report does not take into account the wide range of disciplinary steps boards can take such as letters of reprimand or fines, which are often enough to stop problem behaviors – preempting further problems in the future,” Dr. Chaudhry said.
D.C. gets worst rating
The District of Columbia earned the worst mark in the Public Citizen ranking, holding the 51st spot, the same place it held in the group’s similar ranking on actions taken in the 2017-2019 period. There were 0.19 serious disciplinary actions per 1,000 physicians a year in Washington, Public Citizen said.
In an email to this news organization, Dr. Oshel said that the Public Citizen analysis focused on the number of licensed physicians in each state and D.C. that can be obtained and compared reliably. It avoided using the term “practicing physicians” owing in part to doubts about the reliability of these counts, he said.
As many as 20% of physicians nationwide are focused primarily on work outside of clinical care, Dr. Oshel estimated. In D.C., perhaps 40% of physicians may fall into this category. Of the more than 13,700 physicians licensed in D.C., there may be only about 8,126 actively practicing, according to Dr. Oshel.
But even using that lower estimate of practicing physicians would only raise D.C.’s ranking to 46, signaling a need for stepped-up enforcement, Dr. Oshel said.
“[Whether it’s] 46th or 51st, both are bad,” Dr. Oshel said.
A version of this article first appeared on Medscape.com.
Ontario case shows potential supplement risk for consumers
A woman’s quest to become pregnant resulted in lead poisoning from an Ayurvedic treatment. The case triggered the seizure of pills from an Ontario natural-products clinic and the issuance of government warnings about the risks of products from this business, according to a new report.
, including the presence of lead and other metals in Ayurvedic products, according to the report.
“When consumer products may be contaminated with lead, or when lead exposure is linked to sources in the community, involving public health can facilitate broader actions to reduce and prevent exposures to other people at risk,” wrote report author Julian Gitelman, MD, MPH, a resident physician at the University of Toronto Dalla Lana School of Public Health, and colleagues.
Their case study was published in the Canadian Medical Association Journal.
The researchers detailed what happened after a 39-year-old woman sought medical care for abdominal pain, constipation, nausea, and vomiting. The woman underwent a series of tests, including colonoscopy, laparoscopy, and biopsies of bone marrow and ovarian cysts.
Only later did clinicians home in on the cause of her ailments: the Ayurvedic medications that the patient had been taking daily for more than a year for infertility. Her daily regimen had varied, ranging from a few pills to a dozen pills.
Heavy metals are sometimes intentionally added to Ayurvedic supplements for perceived healing properties, wrote the authors. They cited a previous study of a sample of Ayurvedic pills bought on the Internet from manufacturers based in the United States and India that showed that 21% contained lead, mercury, or arsenic.
A case report published last year in German Medical Weekly raised the same issue.
Melatonin gummies
Regulators in many countries struggle to help consumers understand the risks of natural health supplements, and the challenge extends well beyond Ayurvedic products.
There has been a “huge and very troubling increase” in U.S. poison control calls associated with gummy-bear products containing melatonin, said Canadian Senator Stan Kutcher, MD, at a May 11 meeting of Canada’s Standing Senate Committee on Social Affairs, Science, and Technology.
In April, JAMA published a U.S. analysis of melatonin gummy products, Dr. Kutcher noted. In this research letter, investigators reported that one product did not contain detectable levels of melatonin but did contain 31.3 mg of cannabidiol.
In other products, the quantity of melatonin ranged from 74% to 347% of the labeled quantity. A previous Canadian study of 16 melatonin brands found that the actual dose of melatonin ranged from 17% to 478% of the declared quantity, the letter noted.
The May 11 Senate meeting provided a forum for many of the recurring debates about supplements, which also are known as natural health products.
Barry Power, PharmD, editor in chief for the Canadian Pharmacists Association, said that his group was disappointed when Canada excluded natural health products from Vanessa’s Law, which was passed in 2014. This law sought to improve the reporting of adverse reactions to drugs.
“We’re glad this is being revisited now,” Dr. Power told the Senate committee. “Although natural health products are often seen as low risk, we need to keep in mind that ‘low risk’ does not mean ‘no risk,’ and ‘natural’ does not mean ‘safe.’ ”
In contrast, Aaron Skelton, chief executive of the Canadian Health Food Association, spoke against this bid to expand the reach of Vanessa’s Law into natural health products. Canadian lawmakers attached provisions regarding increased oversight of natural health products to a budget package instead of considering them as part of a stand-alone bill.
“Our concern is that the powers that are being discussed have not been reviewed and debated,” Mr. Skelton told Dr. Kutcher. “The potential for overreach and unnecessary regulation is significant, and that deserves debate.”
“Profits should not trump Canadians’ health,” answered Dr. Kutcher, who earlier served as head of the psychiatry department at Dalhousie University in Halifax, N.S.
By June, Vanessa’s Law had been expanded with provisions that address natural health products, including the reporting of products that present a serious risk to consumers.
Educating consumers
Many consumers overestimate the level of government regulation of supplements, said Pieter A. Cohen, MD, leader of the Supplement Research Program at Cambridge Health Alliance in Massachusetts. Dr. Cohen was the lead author of the JAMA research letter about melatonin products.
Supplements often share shelves in pharmacies with medicines that are subject to more strict regulation, which causes confusion.
“It’s really hard to wrap your brain around [the fact] that a health product is being sold in pharmacies in the United States and it’s not being vetted by the FDA [U.S. Food and Drug Administration]”, Dr. Cohen said in an interview
The confusion extends across borders. Many consumers in other countries will assume that the FDA performed premarket screening of U.S.-made supplements, but that is not the case, he said.
People who want to take supplements should look for reputable sources of information about them, such as the website of the National Institutes of Health’s Office of Dietary Supplements, Dr. Cohen said. But patients often forget or fail to do this, which can create medical puzzles, such as the case of the woman in the Ontario case study, said Peter Lurie, MD, MPH, executive director of the nonprofit Center for Science in the Public Interest, which has pressed for increased regulation of supplements.
Clinicians need to keep in mind that patients may need prodding to reveal what supplements they are taking, he said.
“They just think of them as different, somehow not the province of the doctor,” Dr. Lurie said. “For others, they are concerned that the doctors will disapprove. So, they hide it.”
A version of this article first appeared on Medscape.com.
A woman’s quest to become pregnant resulted in lead poisoning from an Ayurvedic treatment. The case triggered the seizure of pills from an Ontario natural-products clinic and the issuance of government warnings about the risks of products from this business, according to a new report.
, including the presence of lead and other metals in Ayurvedic products, according to the report.
“When consumer products may be contaminated with lead, or when lead exposure is linked to sources in the community, involving public health can facilitate broader actions to reduce and prevent exposures to other people at risk,” wrote report author Julian Gitelman, MD, MPH, a resident physician at the University of Toronto Dalla Lana School of Public Health, and colleagues.
Their case study was published in the Canadian Medical Association Journal.
The researchers detailed what happened after a 39-year-old woman sought medical care for abdominal pain, constipation, nausea, and vomiting. The woman underwent a series of tests, including colonoscopy, laparoscopy, and biopsies of bone marrow and ovarian cysts.
Only later did clinicians home in on the cause of her ailments: the Ayurvedic medications that the patient had been taking daily for more than a year for infertility. Her daily regimen had varied, ranging from a few pills to a dozen pills.
Heavy metals are sometimes intentionally added to Ayurvedic supplements for perceived healing properties, wrote the authors. They cited a previous study of a sample of Ayurvedic pills bought on the Internet from manufacturers based in the United States and India that showed that 21% contained lead, mercury, or arsenic.
A case report published last year in German Medical Weekly raised the same issue.
Melatonin gummies
Regulators in many countries struggle to help consumers understand the risks of natural health supplements, and the challenge extends well beyond Ayurvedic products.
There has been a “huge and very troubling increase” in U.S. poison control calls associated with gummy-bear products containing melatonin, said Canadian Senator Stan Kutcher, MD, at a May 11 meeting of Canada’s Standing Senate Committee on Social Affairs, Science, and Technology.
In April, JAMA published a U.S. analysis of melatonin gummy products, Dr. Kutcher noted. In this research letter, investigators reported that one product did not contain detectable levels of melatonin but did contain 31.3 mg of cannabidiol.
In other products, the quantity of melatonin ranged from 74% to 347% of the labeled quantity. A previous Canadian study of 16 melatonin brands found that the actual dose of melatonin ranged from 17% to 478% of the declared quantity, the letter noted.
The May 11 Senate meeting provided a forum for many of the recurring debates about supplements, which also are known as natural health products.
Barry Power, PharmD, editor in chief for the Canadian Pharmacists Association, said that his group was disappointed when Canada excluded natural health products from Vanessa’s Law, which was passed in 2014. This law sought to improve the reporting of adverse reactions to drugs.
“We’re glad this is being revisited now,” Dr. Power told the Senate committee. “Although natural health products are often seen as low risk, we need to keep in mind that ‘low risk’ does not mean ‘no risk,’ and ‘natural’ does not mean ‘safe.’ ”
In contrast, Aaron Skelton, chief executive of the Canadian Health Food Association, spoke against this bid to expand the reach of Vanessa’s Law into natural health products. Canadian lawmakers attached provisions regarding increased oversight of natural health products to a budget package instead of considering them as part of a stand-alone bill.
“Our concern is that the powers that are being discussed have not been reviewed and debated,” Mr. Skelton told Dr. Kutcher. “The potential for overreach and unnecessary regulation is significant, and that deserves debate.”
“Profits should not trump Canadians’ health,” answered Dr. Kutcher, who earlier served as head of the psychiatry department at Dalhousie University in Halifax, N.S.
By June, Vanessa’s Law had been expanded with provisions that address natural health products, including the reporting of products that present a serious risk to consumers.
Educating consumers
Many consumers overestimate the level of government regulation of supplements, said Pieter A. Cohen, MD, leader of the Supplement Research Program at Cambridge Health Alliance in Massachusetts. Dr. Cohen was the lead author of the JAMA research letter about melatonin products.
Supplements often share shelves in pharmacies with medicines that are subject to more strict regulation, which causes confusion.
“It’s really hard to wrap your brain around [the fact] that a health product is being sold in pharmacies in the United States and it’s not being vetted by the FDA [U.S. Food and Drug Administration]”, Dr. Cohen said in an interview
The confusion extends across borders. Many consumers in other countries will assume that the FDA performed premarket screening of U.S.-made supplements, but that is not the case, he said.
People who want to take supplements should look for reputable sources of information about them, such as the website of the National Institutes of Health’s Office of Dietary Supplements, Dr. Cohen said. But patients often forget or fail to do this, which can create medical puzzles, such as the case of the woman in the Ontario case study, said Peter Lurie, MD, MPH, executive director of the nonprofit Center for Science in the Public Interest, which has pressed for increased regulation of supplements.
Clinicians need to keep in mind that patients may need prodding to reveal what supplements they are taking, he said.
“They just think of them as different, somehow not the province of the doctor,” Dr. Lurie said. “For others, they are concerned that the doctors will disapprove. So, they hide it.”
A version of this article first appeared on Medscape.com.
A woman’s quest to become pregnant resulted in lead poisoning from an Ayurvedic treatment. The case triggered the seizure of pills from an Ontario natural-products clinic and the issuance of government warnings about the risks of products from this business, according to a new report.
, including the presence of lead and other metals in Ayurvedic products, according to the report.
“When consumer products may be contaminated with lead, or when lead exposure is linked to sources in the community, involving public health can facilitate broader actions to reduce and prevent exposures to other people at risk,” wrote report author Julian Gitelman, MD, MPH, a resident physician at the University of Toronto Dalla Lana School of Public Health, and colleagues.
Their case study was published in the Canadian Medical Association Journal.
The researchers detailed what happened after a 39-year-old woman sought medical care for abdominal pain, constipation, nausea, and vomiting. The woman underwent a series of tests, including colonoscopy, laparoscopy, and biopsies of bone marrow and ovarian cysts.
Only later did clinicians home in on the cause of her ailments: the Ayurvedic medications that the patient had been taking daily for more than a year for infertility. Her daily regimen had varied, ranging from a few pills to a dozen pills.
Heavy metals are sometimes intentionally added to Ayurvedic supplements for perceived healing properties, wrote the authors. They cited a previous study of a sample of Ayurvedic pills bought on the Internet from manufacturers based in the United States and India that showed that 21% contained lead, mercury, or arsenic.
A case report published last year in German Medical Weekly raised the same issue.
Melatonin gummies
Regulators in many countries struggle to help consumers understand the risks of natural health supplements, and the challenge extends well beyond Ayurvedic products.
There has been a “huge and very troubling increase” in U.S. poison control calls associated with gummy-bear products containing melatonin, said Canadian Senator Stan Kutcher, MD, at a May 11 meeting of Canada’s Standing Senate Committee on Social Affairs, Science, and Technology.
In April, JAMA published a U.S. analysis of melatonin gummy products, Dr. Kutcher noted. In this research letter, investigators reported that one product did not contain detectable levels of melatonin but did contain 31.3 mg of cannabidiol.
In other products, the quantity of melatonin ranged from 74% to 347% of the labeled quantity. A previous Canadian study of 16 melatonin brands found that the actual dose of melatonin ranged from 17% to 478% of the declared quantity, the letter noted.
The May 11 Senate meeting provided a forum for many of the recurring debates about supplements, which also are known as natural health products.
Barry Power, PharmD, editor in chief for the Canadian Pharmacists Association, said that his group was disappointed when Canada excluded natural health products from Vanessa’s Law, which was passed in 2014. This law sought to improve the reporting of adverse reactions to drugs.
“We’re glad this is being revisited now,” Dr. Power told the Senate committee. “Although natural health products are often seen as low risk, we need to keep in mind that ‘low risk’ does not mean ‘no risk,’ and ‘natural’ does not mean ‘safe.’ ”
In contrast, Aaron Skelton, chief executive of the Canadian Health Food Association, spoke against this bid to expand the reach of Vanessa’s Law into natural health products. Canadian lawmakers attached provisions regarding increased oversight of natural health products to a budget package instead of considering them as part of a stand-alone bill.
“Our concern is that the powers that are being discussed have not been reviewed and debated,” Mr. Skelton told Dr. Kutcher. “The potential for overreach and unnecessary regulation is significant, and that deserves debate.”
“Profits should not trump Canadians’ health,” answered Dr. Kutcher, who earlier served as head of the psychiatry department at Dalhousie University in Halifax, N.S.
By June, Vanessa’s Law had been expanded with provisions that address natural health products, including the reporting of products that present a serious risk to consumers.
Educating consumers
Many consumers overestimate the level of government regulation of supplements, said Pieter A. Cohen, MD, leader of the Supplement Research Program at Cambridge Health Alliance in Massachusetts. Dr. Cohen was the lead author of the JAMA research letter about melatonin products.
Supplements often share shelves in pharmacies with medicines that are subject to more strict regulation, which causes confusion.
“It’s really hard to wrap your brain around [the fact] that a health product is being sold in pharmacies in the United States and it’s not being vetted by the FDA [U.S. Food and Drug Administration]”, Dr. Cohen said in an interview
The confusion extends across borders. Many consumers in other countries will assume that the FDA performed premarket screening of U.S.-made supplements, but that is not the case, he said.
People who want to take supplements should look for reputable sources of information about them, such as the website of the National Institutes of Health’s Office of Dietary Supplements, Dr. Cohen said. But patients often forget or fail to do this, which can create medical puzzles, such as the case of the woman in the Ontario case study, said Peter Lurie, MD, MPH, executive director of the nonprofit Center for Science in the Public Interest, which has pressed for increased regulation of supplements.
Clinicians need to keep in mind that patients may need prodding to reveal what supplements they are taking, he said.
“They just think of them as different, somehow not the province of the doctor,” Dr. Lurie said. “For others, they are concerned that the doctors will disapprove. So, they hide it.”
A version of this article first appeared on Medscape.com.
FROM THE CANADIAN MEDICAL ASSOCIATION JOURNAL