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‘Celebration’ will be ‘short-lived’ if COVID vaccine rushed: Experts
on Wednesday.
The career staff of the Food and Drug Administration can be counted on to appropriately weigh whether a vaccine should be cleared for use in preventing COVID-19, witnesses, including Paul A. Offit, MD, of Children’s Hospital of Philadelphia, told the House Energy and Commerce Committee’s oversight and investigations panel.
FDA staffers would object to attempts by the Trump administration to rush a vaccine to the public without proper vetting, as would veteran federal researchers, including National Institutes of Health Director Francis S. Collins, MD, PhD, and Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, Offit said.
“If COVID-19 vaccines are released before they’re ready to be released, you will hear from these people, and you will also hear from people like Dr. Francis Collins and Tony Fauci, both of whom are trusted by the American public, as well as many other academicians and researchers who wouldn’t stand for this,” he said.
“The public is already nervous about these vaccines,” said Offit, who serves on key FDA and Centers for Disease Control and Prevention committees overseeing vaccine policy. “If trusted health officials stand up and decry a premature release, the celebration by the administration will be short-lived.”
Overly optimistic estimates about a potential approval can only serve to erode the public’s trust in these crucial vaccines, said another witness, Ashish K. Jha, MD, MPH, the dean of Brown University’s School of Public Health, in Providence, Rhode Island.
“All political leaders need to stop talking about things like time lines,” Jha told the lawmakers.
President Donald Trump has several times suggested that a COVID vaccine might be approved ahead of the November 3 election, where he faces a significant challenge from his Democratic rival, former Vice President Joe Biden.
In a Tuesday night debate with Biden, Trump again raised the idea of a quick approval. “Now we’re weeks away from a vaccine,” Trump said during the debate.
Trump’s estimates, though, are not in line with those offered by most firms involved with making vaccines. The most optimistic projections have come from Pfizer Inc. The drugmaker’s chief executive, Albert Bourla, has spoken about his company possibly having data to present to the FDA as early as late October about the safety and effectiveness of a vaccine.
In a September 8 interview with the Today show, Bourla said there was a 60% chance his company would meet that goal. In response to a question, he made it clear his comments applied to a potential Pfizer application, not an approval or release of a vaccine by that time.
In response to concerns about political pressures, the FDA in June issued guidance outlining what its staff would require for approval of a COVID-19 vaccine.
Pushback on politics
Another witness at the Wednesday hearing, Mark McClellan, MD, PhD, a former FDA commissioner (2002 – 2004), pushed back on objections to a potential release of further guidance from the agency.
“Some recent statements from the White House have implied that FDA’s plan to release additional written guidance on its expectations for emergency use authorization of a vaccine is unnecessarily raising the bar on regulatory standards for authorization,” said McClellan in his testimony for the House panel. “That is not the case.”
Instead, further FDA guidance would be a welcome form of feedback for the firms trying to develop COVID-19 vaccines, according to McClellan, who also serves on the board of directors for Johnson & Johnson. Johnson & Johnson is among the firms that have advanced a COVID-19 vaccine candidate to phase 3 testing. In his role as a director, he serves on the board’s regulatory compliance committee.
Along with politics, recent stumbles at FDA with emergency use authorizations (EUAs) of treatments for COVID-19 have eroded the public’s confidence in the agency, Jha told the House panel. The FDA approved hydroxychloroquine, a medicine promoted by Trump for use in COVID, under an EUA in March and then revoked this clearance in June.
Jha said the FDA’s most serious misstep was its handling of convalescent plasma, which was approved through an EUA on August 23 “in a highly advertised and widely televised announcement including the president.
“The announcement solidified in the public conversation the impression that, increasingly with this administration, politics are taking over trusted, nonpartisan scientific institutions,” he said in his testimony.
Approving a COVID-19 vaccine on the limited evidence through an EUA would mark a serious departure from FDA policy, according to Jha.
“While we sometimes accept a certain level of potential harm in experimental treatments for those who are severely ill, vaccines are given to healthy people and therefore need to have a substantially higher measure of safety and effectiveness,” he explained.
Jha said the FDA has only once before used this EUA approach for a vaccine. That was for a vaccine against inhaled anthrax and was mostly distributed to high-risk soldiers and civilians in war zones.
COVID-19, in contrast, is an infection that has changed lives around the world. The virus has contributed to more than 1 million deaths, including more than 200,000 in the United States, according to the World Health Organization.
Scientists are hoping vaccines will help curb this infection, although much of the future success of vaccines depends on how widely they are used, witnesses told the House panel.
Debate on approaches for vaccine effectiveness
In his testimony, Jha also noted concerns about COVID-19 vaccine trials. He included a reference to a Sept. 22 opinion article titled, “These Coronavirus Trials Don›t Answer the One Question We Need to Know,” which was written by Peter Doshi, PhD, of the University of Maryland School of Pharmacy, in Baltimore, and Eric Topol, MD, a professor of molecular medicine at Scripps Research in La Jolla, Calif. Topol is also editor in chief of Medscape.
Topol and Doshi questioned why the firms Moderna, Pfizer, and AstraZeneca structured their competing trials such that “a vaccine could meet the companies’ benchmark for success if it lowered the risk of mild Covid-19, but was never shown to reduce moderate or severe forms of the disease, or the risk of hospitalization, admissions to the intensive care unit or death.”
“To say a vaccine works should mean that most people no longer run the risk of getting seriously sick,” Topol and Doshi wrote. “That’s not what these trials will determine.”
There was disagreement about this point at the hearing. U.S. Representative Morgan Griffith (R-Va.) read the section of the Doshi-Topol article quoted above and asked one witness, Offit, to weigh in.
“Do you agree with those concerns? And either way, tell me why,” Griffith asked.
“I don’t agree,” Offit responded.
“I think it’s actually much harder to prevent asymptomatic infection or mildly symptomatic infection,” he said. “If you can prevent that, you are much more likely to prevent moderate to severe disease. So I think they have it backwards.”
But other researchers also question the approaches used with the current crop of COVID-19 vaccines.
“With the current protocols, it is conceivable that a vaccine might be considered effective – and eventually approved – based primarily on its ability to prevent mild cases alone,” wrote William Haseltine, PhD, president of the nonprofit ACCESS Health International, in a September 22 opinion article in the Washington Post titled: “Beware of COVID-19 Vaccine Trials Designed to Succeed From the Start.”
In an interview with Medscape Medical News on Wednesday, Haseltine said he maintains these concerns about the tests. Earlier in his career, he was a leader in HIV research through his lab at Harvard University in Cambridge, Massachusetts, and he subsequently led a biotech company, Human Genome Sciences.
He fears consumers will not get what they might expect from the vaccines being tested.
“What people care about is if this is going to keep them out of the hospital and will it keep them alive. And that’s not even part of this protocol,” Haseltine said.
This article first appeared on Medscape.com.
on Wednesday.
The career staff of the Food and Drug Administration can be counted on to appropriately weigh whether a vaccine should be cleared for use in preventing COVID-19, witnesses, including Paul A. Offit, MD, of Children’s Hospital of Philadelphia, told the House Energy and Commerce Committee’s oversight and investigations panel.
FDA staffers would object to attempts by the Trump administration to rush a vaccine to the public without proper vetting, as would veteran federal researchers, including National Institutes of Health Director Francis S. Collins, MD, PhD, and Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, Offit said.
“If COVID-19 vaccines are released before they’re ready to be released, you will hear from these people, and you will also hear from people like Dr. Francis Collins and Tony Fauci, both of whom are trusted by the American public, as well as many other academicians and researchers who wouldn’t stand for this,” he said.
“The public is already nervous about these vaccines,” said Offit, who serves on key FDA and Centers for Disease Control and Prevention committees overseeing vaccine policy. “If trusted health officials stand up and decry a premature release, the celebration by the administration will be short-lived.”
Overly optimistic estimates about a potential approval can only serve to erode the public’s trust in these crucial vaccines, said another witness, Ashish K. Jha, MD, MPH, the dean of Brown University’s School of Public Health, in Providence, Rhode Island.
“All political leaders need to stop talking about things like time lines,” Jha told the lawmakers.
President Donald Trump has several times suggested that a COVID vaccine might be approved ahead of the November 3 election, where he faces a significant challenge from his Democratic rival, former Vice President Joe Biden.
In a Tuesday night debate with Biden, Trump again raised the idea of a quick approval. “Now we’re weeks away from a vaccine,” Trump said during the debate.
Trump’s estimates, though, are not in line with those offered by most firms involved with making vaccines. The most optimistic projections have come from Pfizer Inc. The drugmaker’s chief executive, Albert Bourla, has spoken about his company possibly having data to present to the FDA as early as late October about the safety and effectiveness of a vaccine.
In a September 8 interview with the Today show, Bourla said there was a 60% chance his company would meet that goal. In response to a question, he made it clear his comments applied to a potential Pfizer application, not an approval or release of a vaccine by that time.
In response to concerns about political pressures, the FDA in June issued guidance outlining what its staff would require for approval of a COVID-19 vaccine.
Pushback on politics
Another witness at the Wednesday hearing, Mark McClellan, MD, PhD, a former FDA commissioner (2002 – 2004), pushed back on objections to a potential release of further guidance from the agency.
“Some recent statements from the White House have implied that FDA’s plan to release additional written guidance on its expectations for emergency use authorization of a vaccine is unnecessarily raising the bar on regulatory standards for authorization,” said McClellan in his testimony for the House panel. “That is not the case.”
Instead, further FDA guidance would be a welcome form of feedback for the firms trying to develop COVID-19 vaccines, according to McClellan, who also serves on the board of directors for Johnson & Johnson. Johnson & Johnson is among the firms that have advanced a COVID-19 vaccine candidate to phase 3 testing. In his role as a director, he serves on the board’s regulatory compliance committee.
Along with politics, recent stumbles at FDA with emergency use authorizations (EUAs) of treatments for COVID-19 have eroded the public’s confidence in the agency, Jha told the House panel. The FDA approved hydroxychloroquine, a medicine promoted by Trump for use in COVID, under an EUA in March and then revoked this clearance in June.
Jha said the FDA’s most serious misstep was its handling of convalescent plasma, which was approved through an EUA on August 23 “in a highly advertised and widely televised announcement including the president.
“The announcement solidified in the public conversation the impression that, increasingly with this administration, politics are taking over trusted, nonpartisan scientific institutions,” he said in his testimony.
Approving a COVID-19 vaccine on the limited evidence through an EUA would mark a serious departure from FDA policy, according to Jha.
“While we sometimes accept a certain level of potential harm in experimental treatments for those who are severely ill, vaccines are given to healthy people and therefore need to have a substantially higher measure of safety and effectiveness,” he explained.
Jha said the FDA has only once before used this EUA approach for a vaccine. That was for a vaccine against inhaled anthrax and was mostly distributed to high-risk soldiers and civilians in war zones.
COVID-19, in contrast, is an infection that has changed lives around the world. The virus has contributed to more than 1 million deaths, including more than 200,000 in the United States, according to the World Health Organization.
Scientists are hoping vaccines will help curb this infection, although much of the future success of vaccines depends on how widely they are used, witnesses told the House panel.
Debate on approaches for vaccine effectiveness
In his testimony, Jha also noted concerns about COVID-19 vaccine trials. He included a reference to a Sept. 22 opinion article titled, “These Coronavirus Trials Don›t Answer the One Question We Need to Know,” which was written by Peter Doshi, PhD, of the University of Maryland School of Pharmacy, in Baltimore, and Eric Topol, MD, a professor of molecular medicine at Scripps Research in La Jolla, Calif. Topol is also editor in chief of Medscape.
Topol and Doshi questioned why the firms Moderna, Pfizer, and AstraZeneca structured their competing trials such that “a vaccine could meet the companies’ benchmark for success if it lowered the risk of mild Covid-19, but was never shown to reduce moderate or severe forms of the disease, or the risk of hospitalization, admissions to the intensive care unit or death.”
“To say a vaccine works should mean that most people no longer run the risk of getting seriously sick,” Topol and Doshi wrote. “That’s not what these trials will determine.”
There was disagreement about this point at the hearing. U.S. Representative Morgan Griffith (R-Va.) read the section of the Doshi-Topol article quoted above and asked one witness, Offit, to weigh in.
“Do you agree with those concerns? And either way, tell me why,” Griffith asked.
“I don’t agree,” Offit responded.
“I think it’s actually much harder to prevent asymptomatic infection or mildly symptomatic infection,” he said. “If you can prevent that, you are much more likely to prevent moderate to severe disease. So I think they have it backwards.”
But other researchers also question the approaches used with the current crop of COVID-19 vaccines.
“With the current protocols, it is conceivable that a vaccine might be considered effective – and eventually approved – based primarily on its ability to prevent mild cases alone,” wrote William Haseltine, PhD, president of the nonprofit ACCESS Health International, in a September 22 opinion article in the Washington Post titled: “Beware of COVID-19 Vaccine Trials Designed to Succeed From the Start.”
In an interview with Medscape Medical News on Wednesday, Haseltine said he maintains these concerns about the tests. Earlier in his career, he was a leader in HIV research through his lab at Harvard University in Cambridge, Massachusetts, and he subsequently led a biotech company, Human Genome Sciences.
He fears consumers will not get what they might expect from the vaccines being tested.
“What people care about is if this is going to keep them out of the hospital and will it keep them alive. And that’s not even part of this protocol,” Haseltine said.
This article first appeared on Medscape.com.
on Wednesday.
The career staff of the Food and Drug Administration can be counted on to appropriately weigh whether a vaccine should be cleared for use in preventing COVID-19, witnesses, including Paul A. Offit, MD, of Children’s Hospital of Philadelphia, told the House Energy and Commerce Committee’s oversight and investigations panel.
FDA staffers would object to attempts by the Trump administration to rush a vaccine to the public without proper vetting, as would veteran federal researchers, including National Institutes of Health Director Francis S. Collins, MD, PhD, and Anthony S. Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, Offit said.
“If COVID-19 vaccines are released before they’re ready to be released, you will hear from these people, and you will also hear from people like Dr. Francis Collins and Tony Fauci, both of whom are trusted by the American public, as well as many other academicians and researchers who wouldn’t stand for this,” he said.
“The public is already nervous about these vaccines,” said Offit, who serves on key FDA and Centers for Disease Control and Prevention committees overseeing vaccine policy. “If trusted health officials stand up and decry a premature release, the celebration by the administration will be short-lived.”
Overly optimistic estimates about a potential approval can only serve to erode the public’s trust in these crucial vaccines, said another witness, Ashish K. Jha, MD, MPH, the dean of Brown University’s School of Public Health, in Providence, Rhode Island.
“All political leaders need to stop talking about things like time lines,” Jha told the lawmakers.
President Donald Trump has several times suggested that a COVID vaccine might be approved ahead of the November 3 election, where he faces a significant challenge from his Democratic rival, former Vice President Joe Biden.
In a Tuesday night debate with Biden, Trump again raised the idea of a quick approval. “Now we’re weeks away from a vaccine,” Trump said during the debate.
Trump’s estimates, though, are not in line with those offered by most firms involved with making vaccines. The most optimistic projections have come from Pfizer Inc. The drugmaker’s chief executive, Albert Bourla, has spoken about his company possibly having data to present to the FDA as early as late October about the safety and effectiveness of a vaccine.
In a September 8 interview with the Today show, Bourla said there was a 60% chance his company would meet that goal. In response to a question, he made it clear his comments applied to a potential Pfizer application, not an approval or release of a vaccine by that time.
In response to concerns about political pressures, the FDA in June issued guidance outlining what its staff would require for approval of a COVID-19 vaccine.
Pushback on politics
Another witness at the Wednesday hearing, Mark McClellan, MD, PhD, a former FDA commissioner (2002 – 2004), pushed back on objections to a potential release of further guidance from the agency.
“Some recent statements from the White House have implied that FDA’s plan to release additional written guidance on its expectations for emergency use authorization of a vaccine is unnecessarily raising the bar on regulatory standards for authorization,” said McClellan in his testimony for the House panel. “That is not the case.”
Instead, further FDA guidance would be a welcome form of feedback for the firms trying to develop COVID-19 vaccines, according to McClellan, who also serves on the board of directors for Johnson & Johnson. Johnson & Johnson is among the firms that have advanced a COVID-19 vaccine candidate to phase 3 testing. In his role as a director, he serves on the board’s regulatory compliance committee.
Along with politics, recent stumbles at FDA with emergency use authorizations (EUAs) of treatments for COVID-19 have eroded the public’s confidence in the agency, Jha told the House panel. The FDA approved hydroxychloroquine, a medicine promoted by Trump for use in COVID, under an EUA in March and then revoked this clearance in June.
Jha said the FDA’s most serious misstep was its handling of convalescent plasma, which was approved through an EUA on August 23 “in a highly advertised and widely televised announcement including the president.
“The announcement solidified in the public conversation the impression that, increasingly with this administration, politics are taking over trusted, nonpartisan scientific institutions,” he said in his testimony.
Approving a COVID-19 vaccine on the limited evidence through an EUA would mark a serious departure from FDA policy, according to Jha.
“While we sometimes accept a certain level of potential harm in experimental treatments for those who are severely ill, vaccines are given to healthy people and therefore need to have a substantially higher measure of safety and effectiveness,” he explained.
Jha said the FDA has only once before used this EUA approach for a vaccine. That was for a vaccine against inhaled anthrax and was mostly distributed to high-risk soldiers and civilians in war zones.
COVID-19, in contrast, is an infection that has changed lives around the world. The virus has contributed to more than 1 million deaths, including more than 200,000 in the United States, according to the World Health Organization.
Scientists are hoping vaccines will help curb this infection, although much of the future success of vaccines depends on how widely they are used, witnesses told the House panel.
Debate on approaches for vaccine effectiveness
In his testimony, Jha also noted concerns about COVID-19 vaccine trials. He included a reference to a Sept. 22 opinion article titled, “These Coronavirus Trials Don›t Answer the One Question We Need to Know,” which was written by Peter Doshi, PhD, of the University of Maryland School of Pharmacy, in Baltimore, and Eric Topol, MD, a professor of molecular medicine at Scripps Research in La Jolla, Calif. Topol is also editor in chief of Medscape.
Topol and Doshi questioned why the firms Moderna, Pfizer, and AstraZeneca structured their competing trials such that “a vaccine could meet the companies’ benchmark for success if it lowered the risk of mild Covid-19, but was never shown to reduce moderate or severe forms of the disease, or the risk of hospitalization, admissions to the intensive care unit or death.”
“To say a vaccine works should mean that most people no longer run the risk of getting seriously sick,” Topol and Doshi wrote. “That’s not what these trials will determine.”
There was disagreement about this point at the hearing. U.S. Representative Morgan Griffith (R-Va.) read the section of the Doshi-Topol article quoted above and asked one witness, Offit, to weigh in.
“Do you agree with those concerns? And either way, tell me why,” Griffith asked.
“I don’t agree,” Offit responded.
“I think it’s actually much harder to prevent asymptomatic infection or mildly symptomatic infection,” he said. “If you can prevent that, you are much more likely to prevent moderate to severe disease. So I think they have it backwards.”
But other researchers also question the approaches used with the current crop of COVID-19 vaccines.
“With the current protocols, it is conceivable that a vaccine might be considered effective – and eventually approved – based primarily on its ability to prevent mild cases alone,” wrote William Haseltine, PhD, president of the nonprofit ACCESS Health International, in a September 22 opinion article in the Washington Post titled: “Beware of COVID-19 Vaccine Trials Designed to Succeed From the Start.”
In an interview with Medscape Medical News on Wednesday, Haseltine said he maintains these concerns about the tests. Earlier in his career, he was a leader in HIV research through his lab at Harvard University in Cambridge, Massachusetts, and he subsequently led a biotech company, Human Genome Sciences.
He fears consumers will not get what they might expect from the vaccines being tested.
“What people care about is if this is going to keep them out of the hospital and will it keep them alive. And that’s not even part of this protocol,” Haseltine said.
This article first appeared on Medscape.com.
J&J’s one-shot COVID-19 vaccine advances to phase 3 testing
The National Institute of Allergy and Infectious Diseases, which is aiding Johnson & Johnson with development, described this in a news release as the fourth phase 3 clinical trial of evaluating an investigational vaccine for coronavirus disease.
This NIAID tally tracks products likely to be presented soon for Food and Drug Administration approval. (The World Health Organization’s COVID vaccine tracker lists nine candidates as having reached this stage, including products developed in Russia and China.)
As many as 60,000 volunteers will be enrolled in the trial, with about 215 clinical research sites expected to participate, NIAID said. The vaccine will be tested in the United States and abroad.
The start of this test, known as the ENSEMBLE trial, follows positive results from a Phase 1/2a clinical study, which involved a single vaccination. The results of this study have been submitted to medRxiv and are set to be published online imminently.
New Brunswick, N.J–based J&J said it intends to offer the vaccine on “a not-for-profit basis for emergency pandemic use.” If testing proceeds well, J&J might seek an emergency use clearance for the vaccine, which could possibly allow the first batches to be made available in early 2021.
J&J’s vaccine is unusual in that it will be tested based on a single dose, while other advanced candidates have been tested in two-dose regimens.
J&J on Wednesday also released the study protocol for its phase 3 test. The developers of the other late-stage COVID vaccine candidates also have done this, as reported by Medscape Medical News. Because of the great interest in the COVID vaccine, the American Medical Association had last month asked the FDA to keep physicians informed of their COVID-19 vaccine review process.
Trials and tribulations
One of these experimental COVID vaccines already has had a setback in phase 3 testing, which is a fairly routine occurrence in drug development. But with a pandemic still causing deaths and disrupting lives around the world, there has been intense interest in each step of the effort to develop a COVID vaccine.
AstraZeneca PLC earlier this month announced a temporary cessation of all their coronavirus vaccine trials to investigate an “unexplained illness” that arose in a participant, as reported by Medscape Medical News.
On September 12, AstraZeneca announced that clinical trials for the AZD1222, which it developed with Oxford University, had resumed in the United Kingdom. On Wednesday, CNBC said Health and Human Services Secretary Alex Azar told the news station that AstraZeneca’s late-stage coronavirus vaccine trial in the United States remains on hold until safety concerns are resolved, a critical issue with all the fast-track COVID vaccines now being tested.
“Look at the AstraZeneca program, phase 3 clinical trial, a lot of hope. [A] single serious adverse event report in the United Kingdom, global shutdown, and [a] hold of the clinical trials,” Mr. Azar told CNBC.
The New York Times has reported on concerns stemming from serious neurologic illnesses in two participants, both women, who received AstraZeneca’s experimental vaccine in Britain.
The Senate Health, Education, Labor and Pensions Committee on Wednesday separately held a hearing with the leaders of the FDA and the Centers of Disease Control and Prevention, allowing an airing of lawmakers’ concerns about a potential rush to approve a COVID vaccine.
Details of J&J trial
The J&J trial is designed primarily to determine if the investigational vaccine can prevent moderate to severe COVID-19 after a single dose. It also is designed to examine whether the vaccine can prevent COVID-19 requiring medical intervention and if the vaccine can prevent milder cases of COVID-19 and asymptomatic SARS-CoV-2 infection, NIAID said.
Principal investigators for the phase 3 trial of the J & J vaccine are Paul A. Goepfert, MD, director of the Alabama Vaccine Research Clinic at the University of Alabama in Birmingham; Beatriz Grinsztejn, MD, PhD, director of the Laboratory of Clinical Research on HIV/AIDS at the Evandro Chagas National Institute of Infectious Diseases-Oswaldo Cruz Foundation in Rio de Janeiro, Brazil; and Glenda E. Gray, MBBCh, president and chief executive officer of the South African Medical Research Council and coprincipal investigator of the HIV Vaccine Trials Network.
This article first appeared on Medscape.com.
The National Institute of Allergy and Infectious Diseases, which is aiding Johnson & Johnson with development, described this in a news release as the fourth phase 3 clinical trial of evaluating an investigational vaccine for coronavirus disease.
This NIAID tally tracks products likely to be presented soon for Food and Drug Administration approval. (The World Health Organization’s COVID vaccine tracker lists nine candidates as having reached this stage, including products developed in Russia and China.)
As many as 60,000 volunteers will be enrolled in the trial, with about 215 clinical research sites expected to participate, NIAID said. The vaccine will be tested in the United States and abroad.
The start of this test, known as the ENSEMBLE trial, follows positive results from a Phase 1/2a clinical study, which involved a single vaccination. The results of this study have been submitted to medRxiv and are set to be published online imminently.
New Brunswick, N.J–based J&J said it intends to offer the vaccine on “a not-for-profit basis for emergency pandemic use.” If testing proceeds well, J&J might seek an emergency use clearance for the vaccine, which could possibly allow the first batches to be made available in early 2021.
J&J’s vaccine is unusual in that it will be tested based on a single dose, while other advanced candidates have been tested in two-dose regimens.
J&J on Wednesday also released the study protocol for its phase 3 test. The developers of the other late-stage COVID vaccine candidates also have done this, as reported by Medscape Medical News. Because of the great interest in the COVID vaccine, the American Medical Association had last month asked the FDA to keep physicians informed of their COVID-19 vaccine review process.
Trials and tribulations
One of these experimental COVID vaccines already has had a setback in phase 3 testing, which is a fairly routine occurrence in drug development. But with a pandemic still causing deaths and disrupting lives around the world, there has been intense interest in each step of the effort to develop a COVID vaccine.
AstraZeneca PLC earlier this month announced a temporary cessation of all their coronavirus vaccine trials to investigate an “unexplained illness” that arose in a participant, as reported by Medscape Medical News.
On September 12, AstraZeneca announced that clinical trials for the AZD1222, which it developed with Oxford University, had resumed in the United Kingdom. On Wednesday, CNBC said Health and Human Services Secretary Alex Azar told the news station that AstraZeneca’s late-stage coronavirus vaccine trial in the United States remains on hold until safety concerns are resolved, a critical issue with all the fast-track COVID vaccines now being tested.
“Look at the AstraZeneca program, phase 3 clinical trial, a lot of hope. [A] single serious adverse event report in the United Kingdom, global shutdown, and [a] hold of the clinical trials,” Mr. Azar told CNBC.
The New York Times has reported on concerns stemming from serious neurologic illnesses in two participants, both women, who received AstraZeneca’s experimental vaccine in Britain.
The Senate Health, Education, Labor and Pensions Committee on Wednesday separately held a hearing with the leaders of the FDA and the Centers of Disease Control and Prevention, allowing an airing of lawmakers’ concerns about a potential rush to approve a COVID vaccine.
Details of J&J trial
The J&J trial is designed primarily to determine if the investigational vaccine can prevent moderate to severe COVID-19 after a single dose. It also is designed to examine whether the vaccine can prevent COVID-19 requiring medical intervention and if the vaccine can prevent milder cases of COVID-19 and asymptomatic SARS-CoV-2 infection, NIAID said.
Principal investigators for the phase 3 trial of the J & J vaccine are Paul A. Goepfert, MD, director of the Alabama Vaccine Research Clinic at the University of Alabama in Birmingham; Beatriz Grinsztejn, MD, PhD, director of the Laboratory of Clinical Research on HIV/AIDS at the Evandro Chagas National Institute of Infectious Diseases-Oswaldo Cruz Foundation in Rio de Janeiro, Brazil; and Glenda E. Gray, MBBCh, president and chief executive officer of the South African Medical Research Council and coprincipal investigator of the HIV Vaccine Trials Network.
This article first appeared on Medscape.com.
The National Institute of Allergy and Infectious Diseases, which is aiding Johnson & Johnson with development, described this in a news release as the fourth phase 3 clinical trial of evaluating an investigational vaccine for coronavirus disease.
This NIAID tally tracks products likely to be presented soon for Food and Drug Administration approval. (The World Health Organization’s COVID vaccine tracker lists nine candidates as having reached this stage, including products developed in Russia and China.)
As many as 60,000 volunteers will be enrolled in the trial, with about 215 clinical research sites expected to participate, NIAID said. The vaccine will be tested in the United States and abroad.
The start of this test, known as the ENSEMBLE trial, follows positive results from a Phase 1/2a clinical study, which involved a single vaccination. The results of this study have been submitted to medRxiv and are set to be published online imminently.
New Brunswick, N.J–based J&J said it intends to offer the vaccine on “a not-for-profit basis for emergency pandemic use.” If testing proceeds well, J&J might seek an emergency use clearance for the vaccine, which could possibly allow the first batches to be made available in early 2021.
J&J’s vaccine is unusual in that it will be tested based on a single dose, while other advanced candidates have been tested in two-dose regimens.
J&J on Wednesday also released the study protocol for its phase 3 test. The developers of the other late-stage COVID vaccine candidates also have done this, as reported by Medscape Medical News. Because of the great interest in the COVID vaccine, the American Medical Association had last month asked the FDA to keep physicians informed of their COVID-19 vaccine review process.
Trials and tribulations
One of these experimental COVID vaccines already has had a setback in phase 3 testing, which is a fairly routine occurrence in drug development. But with a pandemic still causing deaths and disrupting lives around the world, there has been intense interest in each step of the effort to develop a COVID vaccine.
AstraZeneca PLC earlier this month announced a temporary cessation of all their coronavirus vaccine trials to investigate an “unexplained illness” that arose in a participant, as reported by Medscape Medical News.
On September 12, AstraZeneca announced that clinical trials for the AZD1222, which it developed with Oxford University, had resumed in the United Kingdom. On Wednesday, CNBC said Health and Human Services Secretary Alex Azar told the news station that AstraZeneca’s late-stage coronavirus vaccine trial in the United States remains on hold until safety concerns are resolved, a critical issue with all the fast-track COVID vaccines now being tested.
“Look at the AstraZeneca program, phase 3 clinical trial, a lot of hope. [A] single serious adverse event report in the United Kingdom, global shutdown, and [a] hold of the clinical trials,” Mr. Azar told CNBC.
The New York Times has reported on concerns stemming from serious neurologic illnesses in two participants, both women, who received AstraZeneca’s experimental vaccine in Britain.
The Senate Health, Education, Labor and Pensions Committee on Wednesday separately held a hearing with the leaders of the FDA and the Centers of Disease Control and Prevention, allowing an airing of lawmakers’ concerns about a potential rush to approve a COVID vaccine.
Details of J&J trial
The J&J trial is designed primarily to determine if the investigational vaccine can prevent moderate to severe COVID-19 after a single dose. It also is designed to examine whether the vaccine can prevent COVID-19 requiring medical intervention and if the vaccine can prevent milder cases of COVID-19 and asymptomatic SARS-CoV-2 infection, NIAID said.
Principal investigators for the phase 3 trial of the J & J vaccine are Paul A. Goepfert, MD, director of the Alabama Vaccine Research Clinic at the University of Alabama in Birmingham; Beatriz Grinsztejn, MD, PhD, director of the Laboratory of Clinical Research on HIV/AIDS at the Evandro Chagas National Institute of Infectious Diseases-Oswaldo Cruz Foundation in Rio de Janeiro, Brazil; and Glenda E. Gray, MBBCh, president and chief executive officer of the South African Medical Research Council and coprincipal investigator of the HIV Vaccine Trials Network.
This article first appeared on Medscape.com.
New billing code for added COVID practice expense
The American Medical Association on Sept. 8 announced that a new code, 99072, is intended to cover additional supplies, materials, and clinical staff time over and above those usually included in an office visit when performed during a declared public health emergency, as defined by law, attributable to respiratory-transmitted infectious disease, the AMA said in a release.
Fifty national medical specialty societies and other organizations worked with the AMA’s Specialty Society RVS Update Committee over the summer to collect data on the costs of maintaining safe medical offices during the public health emergency. It has submitted recommendations to the Centers for Medicare & Medicaid Services seeking to persuade the federal agencies to recognize the new 99072 payment code.
The intention is to recognize the extra expenses involved in steps now routinely taken to reduce the risk for COVID transmission from office visits, Current Procedural Terminology Editorial Panel Chair Mark S. Synovec, MD, said in an interview. Some practices have adapted by having staff screen patients before they enter offices and making arrangements to keep patients at a safe distance from others during their visits, he said.
“Everyone’s life has significantly changed because of COVID and the health care system has dramatically changed,” Dr. Synovec said. “It was pretty clear that the status quo was not going to work.”
Physician practices will welcome this change, said Veronica Bradley, CPC, a senior industry adviser to the Medical Group Management Association. An office visit that in the past may have involved only basic infection control measures, such as donning a pair of gloves, now may involve clinicians taking the time to put on more extensive protective gear, she said.
“Now they are taking a heck of a lot more precautions, and there’s more time and more supplies being consumed,” Ms. Bradley said in an interview.
Code looks ahead to future use
The AMA explained how this new code differs from CPT code 99070, which is typically reported for supplies and materials that may be used or provided to patients during an office visit.
The new 99072 code applies only during declared public health emergencies and applies only to additional items required to support “a safe in-person provision” of evaluation, treatment, and procedures, the AMA said.
“These items contrast with those typically reported with code 99070, which focuses on additional supplies provided over and above those usually included with a specific service, such as drugs, intravenous catheters, or trays,” the AMA said.
The CPT panel sought to structure the new code for covering COVID practice expenses so that it could not be abused, and also looked ahead to the future, Dr. Synovec said.
“It’s a code that you would put on during a public health emergency as defined by law that would be related to a respiratory-transmitted infectious disease. Obviously we meant it for SARS-CoV-2,” he said. “Hopefully we can go another 100 years before we have another pandemic, but we also wanted to prepare something where if we have another airborne respiratory virus that requires additional practice expenses as seen this time, it would be available for use.”
The AMA also announced a second addition, CPT code 86413, that anticipates greater use of quantitative measurements of SARS-CoV-2 antibodies, as opposed to a qualitative assessment (positive/negative) provided by laboratory tests reported by other CPT codes.
More information is available on the AMA website.
A version of this article originally appeared on Medscape.com.
The American Medical Association on Sept. 8 announced that a new code, 99072, is intended to cover additional supplies, materials, and clinical staff time over and above those usually included in an office visit when performed during a declared public health emergency, as defined by law, attributable to respiratory-transmitted infectious disease, the AMA said in a release.
Fifty national medical specialty societies and other organizations worked with the AMA’s Specialty Society RVS Update Committee over the summer to collect data on the costs of maintaining safe medical offices during the public health emergency. It has submitted recommendations to the Centers for Medicare & Medicaid Services seeking to persuade the federal agencies to recognize the new 99072 payment code.
The intention is to recognize the extra expenses involved in steps now routinely taken to reduce the risk for COVID transmission from office visits, Current Procedural Terminology Editorial Panel Chair Mark S. Synovec, MD, said in an interview. Some practices have adapted by having staff screen patients before they enter offices and making arrangements to keep patients at a safe distance from others during their visits, he said.
“Everyone’s life has significantly changed because of COVID and the health care system has dramatically changed,” Dr. Synovec said. “It was pretty clear that the status quo was not going to work.”
Physician practices will welcome this change, said Veronica Bradley, CPC, a senior industry adviser to the Medical Group Management Association. An office visit that in the past may have involved only basic infection control measures, such as donning a pair of gloves, now may involve clinicians taking the time to put on more extensive protective gear, she said.
“Now they are taking a heck of a lot more precautions, and there’s more time and more supplies being consumed,” Ms. Bradley said in an interview.
Code looks ahead to future use
The AMA explained how this new code differs from CPT code 99070, which is typically reported for supplies and materials that may be used or provided to patients during an office visit.
The new 99072 code applies only during declared public health emergencies and applies only to additional items required to support “a safe in-person provision” of evaluation, treatment, and procedures, the AMA said.
“These items contrast with those typically reported with code 99070, which focuses on additional supplies provided over and above those usually included with a specific service, such as drugs, intravenous catheters, or trays,” the AMA said.
The CPT panel sought to structure the new code for covering COVID practice expenses so that it could not be abused, and also looked ahead to the future, Dr. Synovec said.
“It’s a code that you would put on during a public health emergency as defined by law that would be related to a respiratory-transmitted infectious disease. Obviously we meant it for SARS-CoV-2,” he said. “Hopefully we can go another 100 years before we have another pandemic, but we also wanted to prepare something where if we have another airborne respiratory virus that requires additional practice expenses as seen this time, it would be available for use.”
The AMA also announced a second addition, CPT code 86413, that anticipates greater use of quantitative measurements of SARS-CoV-2 antibodies, as opposed to a qualitative assessment (positive/negative) provided by laboratory tests reported by other CPT codes.
More information is available on the AMA website.
A version of this article originally appeared on Medscape.com.
The American Medical Association on Sept. 8 announced that a new code, 99072, is intended to cover additional supplies, materials, and clinical staff time over and above those usually included in an office visit when performed during a declared public health emergency, as defined by law, attributable to respiratory-transmitted infectious disease, the AMA said in a release.
Fifty national medical specialty societies and other organizations worked with the AMA’s Specialty Society RVS Update Committee over the summer to collect data on the costs of maintaining safe medical offices during the public health emergency. It has submitted recommendations to the Centers for Medicare & Medicaid Services seeking to persuade the federal agencies to recognize the new 99072 payment code.
The intention is to recognize the extra expenses involved in steps now routinely taken to reduce the risk for COVID transmission from office visits, Current Procedural Terminology Editorial Panel Chair Mark S. Synovec, MD, said in an interview. Some practices have adapted by having staff screen patients before they enter offices and making arrangements to keep patients at a safe distance from others during their visits, he said.
“Everyone’s life has significantly changed because of COVID and the health care system has dramatically changed,” Dr. Synovec said. “It was pretty clear that the status quo was not going to work.”
Physician practices will welcome this change, said Veronica Bradley, CPC, a senior industry adviser to the Medical Group Management Association. An office visit that in the past may have involved only basic infection control measures, such as donning a pair of gloves, now may involve clinicians taking the time to put on more extensive protective gear, she said.
“Now they are taking a heck of a lot more precautions, and there’s more time and more supplies being consumed,” Ms. Bradley said in an interview.
Code looks ahead to future use
The AMA explained how this new code differs from CPT code 99070, which is typically reported for supplies and materials that may be used or provided to patients during an office visit.
The new 99072 code applies only during declared public health emergencies and applies only to additional items required to support “a safe in-person provision” of evaluation, treatment, and procedures, the AMA said.
“These items contrast with those typically reported with code 99070, which focuses on additional supplies provided over and above those usually included with a specific service, such as drugs, intravenous catheters, or trays,” the AMA said.
The CPT panel sought to structure the new code for covering COVID practice expenses so that it could not be abused, and also looked ahead to the future, Dr. Synovec said.
“It’s a code that you would put on during a public health emergency as defined by law that would be related to a respiratory-transmitted infectious disease. Obviously we meant it for SARS-CoV-2,” he said. “Hopefully we can go another 100 years before we have another pandemic, but we also wanted to prepare something where if we have another airborne respiratory virus that requires additional practice expenses as seen this time, it would be available for use.”
The AMA also announced a second addition, CPT code 86413, that anticipates greater use of quantitative measurements of SARS-CoV-2 antibodies, as opposed to a qualitative assessment (positive/negative) provided by laboratory tests reported by other CPT codes.
More information is available on the AMA website.
A version of this article originally appeared on Medscape.com.
Sleep disorders may be undetected precursors for cardiometabolic disease in U.S. Latinos
Sleep disorders may be silent precursors of cardiometabolic disease among U.S. Latinos, said authors of a newly published study.
Xiaoyu Li, ScD, and Susan Redline, MD, MPH, of Harvard Medical School and Brigham and Women’s Hospital, Boston, and coauthors conducted a study of people who self-identified as Latino, who had baseline sleeping disorders, and who developed hypertension and diabetes over time. The study was published in the American Journal of Respiratory and Critical Care Medicine.
The findings suggested that sleep disorders preceded the development of hypertension and diabetes. Examining records from a major multiyear federal project, the Hispanic Community Health Study/Study of Latinos, Dr. Li, Dr. Redline, and coauthors found sleep-disordered breathing (SDB) was associated with a 1.54 higher adjusted odds of incident hypertension (95% confidence interval [CI], 1.18-2.00) and 1.33 higher odds of incident diabetes (95% CI, 1.05-1.67), compared with no SDB. Insomnia was associated with incident hypertension (odds ratio, 1.37; 95% CI, 1.11-1.69), but not diabetes. The association between insomnia and incident hypertension was stronger among men than women, they reported.
“We now need large-scale rigorous trials to evaluate the impact of early treatment of sleep disordered breathing and insomnia on preventing the development of hypertension and diabetes,” Dr. Redline said in an interview. “Clinicians should consider screening their patients at risk for hypertension and diabetes for both sleep-disordered breathing and insomnia.”
Implications for public health strategies
The study results may have implications for health strategies and policies aimed at addressing health differentials among ethnic and economic groups in the United States.
Suboptimal sleep health may be an important fundamental but understudied contributor to health disparities, Chandra L. Jackson, PhD, MS, of the National Institute of Environmental Health Sciences, Research Triangle, N.C., said in an interview. Dr. Jackson is the lead author for a report published in August on a 2018 National Institutes of Health workshop regarding the importance of studying sleep health disparities (Sleep 2020 Mar 10. doi: 10.1093/sleep/zsaa037). The NIH workshop emphasized how little research has been done on the prevalence, incidence, morbidity, or mortality of sleep deficiencies of racial and ethnic minority populations, even though members of these groups are generally more likely to experience sleep disorders. The report urged “a nuanced integration between health disparity causal pathways and sleep and circadian-related mechanisms” tailored for these groups, with attention paid to sociocultural context.
Dr. Jackson said the study by Dr. Li and colleagues fits nicely with the strategies recommended in this report. She added: “Prospective design is particularly important for establishing temporality or that the SDB and insomnia symptoms occurred before the outcomes of hypertension and diabetes.”
In commenting on the Xi/Redline paper, Krishna M. Sundar, MD, FCCP, medical director of the Sleep-Wake Center at the University of Utah, Salt Lake City, commended the study and noted that one of the challenges in sleep research is the long time period over which the effects of disordered breathing become clear, he said.
“Things don’t happen immediately. It takes months, years for the effects to develop,” Dr. Sundar said. “To try to piece together the relationships, you need very well planned studies.”
Study design: Participants and exclusions
Latinos currently make up 17.8%, or 57.5 million, of the U.S. population, and this group is expected to double within the next 4 decades, the investigators wrote. A few prior studies on the roles of sleep disorders in the cardiometabolic health of Latinos, though suggestive, were limited by cross-sectional designs, relatively small samples, and underrepresentation of various Latino heritage groups.
The investigators on this new study worked with data from the federal Hispanic Community Health Study/Study of Latinos (HCHS/SOL) in which more than 16,000 people participated.
This multiyear federal study drew people who self-identified with different heritage groups, including Cuban, Dominican, Mexican, Central American, South American, and Puerto Rican. Participants initially aged 18-74 years underwent a first round of exams and assessments between 2008 and 2011 to determine what risk factors they had at the start of the study. In the second phase, which took place from 2013 to 2018, participants had a second set of exams. The National Heart, Lung, and Blood Institute and the National Institute of Diabetes and Digestive and Kidney Diseases funded the HCHS/SOL.
The investigators initially had a potential data pool of 11,623 participants in the HCHS/SOL. About 1 of 8 in this group, or 1,424 participants (12.3%), did not undergo a sleep study or did not have sufficient sleep data for analyses. Another 93 (0.8%) participants were excluded for missing data on covariates.
For incident hypertension analyses, participants who had prevalent hypertension at the first screening in the HCHS/SOL (n = 3,139) or had missing data on hypertension (n = 2) were excluded. That resulted in an analytic sample of 6,965 for hypertension questions.
For incident diabetes analyses, participants who had prevalent diabetes at the first screening (n = 2,062) or had missing data on diabetes (n = 21) were excluded, yielding an analytic sample of 8,023.
Incident hypertension was defined as participants not having hypertension at baseline and having hypertension, defined as a systolic blood pressure 140 mm Hg or greater, diastolic blood pressure 90 mm Hg or greater, or receiving antihypertensive medication within 4 weeks, at the second round of screening.
Cardiometabolic disease definitions
The researchers did not discriminate between type 1 and type 2 diabetes. They used the American Diabetes Association definition as a fasting plasma glucose 126 mg/dL or greater, 2-hour, postload plasma glucose 200 mg/dL or greater, or hemoglobin A1c 6.5% or greater, with an additional criterion on self-reported use of antidiabetic medication within 4 weeks before the visit.
In line with previous research, the investigators controlled for potential confounders measured at baseline including sociodemographic factors, health behaviors, and adiposity, which are considered important risk factors for both sleep disorders and incident metabolic diseases. These factors include education level, age, gender, and body mass index and whether participants had ever been smokers or users of alcohol.
Study limitations
Limitations of the study include use of a home sleep apnea test device that did not allow evaluation of arousal or sleep architecture. The researchers said this may have led to an underestimation of disease severity both due to overestimation of sleep time and underrecognition of hypopneas unassociated with desaturation. In addition, prior research has suggested that minority populations might underreport sleep disturbances, possibly “due to social desirability (a tendency not to encode a negative event), stress, stereotype threat, acculturation, attitudes, etc.” The participants were recruited mostly from urban areas, and the results might not be generalized to rural populations. In addition, 41% of study participants were of Mexican heritage, compared with 63% of the Hispanic population being of Mexican heritage in the United States.
Another researcher in the field of health disparities, Julia Roncoroni, PhD, assistant professor of psychology at the University of Denver, also noted this slight underrepresentation of Hispanics of Mexican origin and an overrepresentation of urban individuals in the HCHS/SOL.
“However, using data from HCHS/SOL, which is the largest multicenter epidemiological study of cardiovascular risk factors and sleep traits in U.S. Hispanics/Latinx, allows researchers to answer a high-impact question that would otherwise be prohibitively expensive and time consuming,” wrote Dr. Roncoroni.
Conclusions
The study offers “the first prospective evidence on the associations between SDB and insomnia with incident hypertension and diabetes in US Hispanics/Latinos.” The investigators concluded: “Given the fact that sleep disorders are largely undiagnosed and undertreated, they might represent modifiable targets for disease prevention and reduction among US Hispanics/Latinos. Culturally informed interventions focusing on detecting and treating sleep disorders might improve cardiometabolic health among US Hispanics/Latinos.”
Dr. Redline was partially supported by NIH grant R35 HL135818. This study drew from the Hispanic Community Health Study/Study of Latinos, which has been supported by contracts from the National Heart, Lung, and Blood Institute.
SOURCE: Li X et al. Am J Respir Crit Care Med. 2020 Aug 6. doi: 10.1164/rccm.201912-2330OC.
Sleep disorders may be silent precursors of cardiometabolic disease among U.S. Latinos, said authors of a newly published study.
Xiaoyu Li, ScD, and Susan Redline, MD, MPH, of Harvard Medical School and Brigham and Women’s Hospital, Boston, and coauthors conducted a study of people who self-identified as Latino, who had baseline sleeping disorders, and who developed hypertension and diabetes over time. The study was published in the American Journal of Respiratory and Critical Care Medicine.
The findings suggested that sleep disorders preceded the development of hypertension and diabetes. Examining records from a major multiyear federal project, the Hispanic Community Health Study/Study of Latinos, Dr. Li, Dr. Redline, and coauthors found sleep-disordered breathing (SDB) was associated with a 1.54 higher adjusted odds of incident hypertension (95% confidence interval [CI], 1.18-2.00) and 1.33 higher odds of incident diabetes (95% CI, 1.05-1.67), compared with no SDB. Insomnia was associated with incident hypertension (odds ratio, 1.37; 95% CI, 1.11-1.69), but not diabetes. The association between insomnia and incident hypertension was stronger among men than women, they reported.
“We now need large-scale rigorous trials to evaluate the impact of early treatment of sleep disordered breathing and insomnia on preventing the development of hypertension and diabetes,” Dr. Redline said in an interview. “Clinicians should consider screening their patients at risk for hypertension and diabetes for both sleep-disordered breathing and insomnia.”
Implications for public health strategies
The study results may have implications for health strategies and policies aimed at addressing health differentials among ethnic and economic groups in the United States.
Suboptimal sleep health may be an important fundamental but understudied contributor to health disparities, Chandra L. Jackson, PhD, MS, of the National Institute of Environmental Health Sciences, Research Triangle, N.C., said in an interview. Dr. Jackson is the lead author for a report published in August on a 2018 National Institutes of Health workshop regarding the importance of studying sleep health disparities (Sleep 2020 Mar 10. doi: 10.1093/sleep/zsaa037). The NIH workshop emphasized how little research has been done on the prevalence, incidence, morbidity, or mortality of sleep deficiencies of racial and ethnic minority populations, even though members of these groups are generally more likely to experience sleep disorders. The report urged “a nuanced integration between health disparity causal pathways and sleep and circadian-related mechanisms” tailored for these groups, with attention paid to sociocultural context.
Dr. Jackson said the study by Dr. Li and colleagues fits nicely with the strategies recommended in this report. She added: “Prospective design is particularly important for establishing temporality or that the SDB and insomnia symptoms occurred before the outcomes of hypertension and diabetes.”
In commenting on the Xi/Redline paper, Krishna M. Sundar, MD, FCCP, medical director of the Sleep-Wake Center at the University of Utah, Salt Lake City, commended the study and noted that one of the challenges in sleep research is the long time period over which the effects of disordered breathing become clear, he said.
“Things don’t happen immediately. It takes months, years for the effects to develop,” Dr. Sundar said. “To try to piece together the relationships, you need very well planned studies.”
Study design: Participants and exclusions
Latinos currently make up 17.8%, or 57.5 million, of the U.S. population, and this group is expected to double within the next 4 decades, the investigators wrote. A few prior studies on the roles of sleep disorders in the cardiometabolic health of Latinos, though suggestive, were limited by cross-sectional designs, relatively small samples, and underrepresentation of various Latino heritage groups.
The investigators on this new study worked with data from the federal Hispanic Community Health Study/Study of Latinos (HCHS/SOL) in which more than 16,000 people participated.
This multiyear federal study drew people who self-identified with different heritage groups, including Cuban, Dominican, Mexican, Central American, South American, and Puerto Rican. Participants initially aged 18-74 years underwent a first round of exams and assessments between 2008 and 2011 to determine what risk factors they had at the start of the study. In the second phase, which took place from 2013 to 2018, participants had a second set of exams. The National Heart, Lung, and Blood Institute and the National Institute of Diabetes and Digestive and Kidney Diseases funded the HCHS/SOL.
The investigators initially had a potential data pool of 11,623 participants in the HCHS/SOL. About 1 of 8 in this group, or 1,424 participants (12.3%), did not undergo a sleep study or did not have sufficient sleep data for analyses. Another 93 (0.8%) participants were excluded for missing data on covariates.
For incident hypertension analyses, participants who had prevalent hypertension at the first screening in the HCHS/SOL (n = 3,139) or had missing data on hypertension (n = 2) were excluded. That resulted in an analytic sample of 6,965 for hypertension questions.
For incident diabetes analyses, participants who had prevalent diabetes at the first screening (n = 2,062) or had missing data on diabetes (n = 21) were excluded, yielding an analytic sample of 8,023.
Incident hypertension was defined as participants not having hypertension at baseline and having hypertension, defined as a systolic blood pressure 140 mm Hg or greater, diastolic blood pressure 90 mm Hg or greater, or receiving antihypertensive medication within 4 weeks, at the second round of screening.
Cardiometabolic disease definitions
The researchers did not discriminate between type 1 and type 2 diabetes. They used the American Diabetes Association definition as a fasting plasma glucose 126 mg/dL or greater, 2-hour, postload plasma glucose 200 mg/dL or greater, or hemoglobin A1c 6.5% or greater, with an additional criterion on self-reported use of antidiabetic medication within 4 weeks before the visit.
In line with previous research, the investigators controlled for potential confounders measured at baseline including sociodemographic factors, health behaviors, and adiposity, which are considered important risk factors for both sleep disorders and incident metabolic diseases. These factors include education level, age, gender, and body mass index and whether participants had ever been smokers or users of alcohol.
Study limitations
Limitations of the study include use of a home sleep apnea test device that did not allow evaluation of arousal or sleep architecture. The researchers said this may have led to an underestimation of disease severity both due to overestimation of sleep time and underrecognition of hypopneas unassociated with desaturation. In addition, prior research has suggested that minority populations might underreport sleep disturbances, possibly “due to social desirability (a tendency not to encode a negative event), stress, stereotype threat, acculturation, attitudes, etc.” The participants were recruited mostly from urban areas, and the results might not be generalized to rural populations. In addition, 41% of study participants were of Mexican heritage, compared with 63% of the Hispanic population being of Mexican heritage in the United States.
Another researcher in the field of health disparities, Julia Roncoroni, PhD, assistant professor of psychology at the University of Denver, also noted this slight underrepresentation of Hispanics of Mexican origin and an overrepresentation of urban individuals in the HCHS/SOL.
“However, using data from HCHS/SOL, which is the largest multicenter epidemiological study of cardiovascular risk factors and sleep traits in U.S. Hispanics/Latinx, allows researchers to answer a high-impact question that would otherwise be prohibitively expensive and time consuming,” wrote Dr. Roncoroni.
Conclusions
The study offers “the first prospective evidence on the associations between SDB and insomnia with incident hypertension and diabetes in US Hispanics/Latinos.” The investigators concluded: “Given the fact that sleep disorders are largely undiagnosed and undertreated, they might represent modifiable targets for disease prevention and reduction among US Hispanics/Latinos. Culturally informed interventions focusing on detecting and treating sleep disorders might improve cardiometabolic health among US Hispanics/Latinos.”
Dr. Redline was partially supported by NIH grant R35 HL135818. This study drew from the Hispanic Community Health Study/Study of Latinos, which has been supported by contracts from the National Heart, Lung, and Blood Institute.
SOURCE: Li X et al. Am J Respir Crit Care Med. 2020 Aug 6. doi: 10.1164/rccm.201912-2330OC.
Sleep disorders may be silent precursors of cardiometabolic disease among U.S. Latinos, said authors of a newly published study.
Xiaoyu Li, ScD, and Susan Redline, MD, MPH, of Harvard Medical School and Brigham and Women’s Hospital, Boston, and coauthors conducted a study of people who self-identified as Latino, who had baseline sleeping disorders, and who developed hypertension and diabetes over time. The study was published in the American Journal of Respiratory and Critical Care Medicine.
The findings suggested that sleep disorders preceded the development of hypertension and diabetes. Examining records from a major multiyear federal project, the Hispanic Community Health Study/Study of Latinos, Dr. Li, Dr. Redline, and coauthors found sleep-disordered breathing (SDB) was associated with a 1.54 higher adjusted odds of incident hypertension (95% confidence interval [CI], 1.18-2.00) and 1.33 higher odds of incident diabetes (95% CI, 1.05-1.67), compared with no SDB. Insomnia was associated with incident hypertension (odds ratio, 1.37; 95% CI, 1.11-1.69), but not diabetes. The association between insomnia and incident hypertension was stronger among men than women, they reported.
“We now need large-scale rigorous trials to evaluate the impact of early treatment of sleep disordered breathing and insomnia on preventing the development of hypertension and diabetes,” Dr. Redline said in an interview. “Clinicians should consider screening their patients at risk for hypertension and diabetes for both sleep-disordered breathing and insomnia.”
Implications for public health strategies
The study results may have implications for health strategies and policies aimed at addressing health differentials among ethnic and economic groups in the United States.
Suboptimal sleep health may be an important fundamental but understudied contributor to health disparities, Chandra L. Jackson, PhD, MS, of the National Institute of Environmental Health Sciences, Research Triangle, N.C., said in an interview. Dr. Jackson is the lead author for a report published in August on a 2018 National Institutes of Health workshop regarding the importance of studying sleep health disparities (Sleep 2020 Mar 10. doi: 10.1093/sleep/zsaa037). The NIH workshop emphasized how little research has been done on the prevalence, incidence, morbidity, or mortality of sleep deficiencies of racial and ethnic minority populations, even though members of these groups are generally more likely to experience sleep disorders. The report urged “a nuanced integration between health disparity causal pathways and sleep and circadian-related mechanisms” tailored for these groups, with attention paid to sociocultural context.
Dr. Jackson said the study by Dr. Li and colleagues fits nicely with the strategies recommended in this report. She added: “Prospective design is particularly important for establishing temporality or that the SDB and insomnia symptoms occurred before the outcomes of hypertension and diabetes.”
In commenting on the Xi/Redline paper, Krishna M. Sundar, MD, FCCP, medical director of the Sleep-Wake Center at the University of Utah, Salt Lake City, commended the study and noted that one of the challenges in sleep research is the long time period over which the effects of disordered breathing become clear, he said.
“Things don’t happen immediately. It takes months, years for the effects to develop,” Dr. Sundar said. “To try to piece together the relationships, you need very well planned studies.”
Study design: Participants and exclusions
Latinos currently make up 17.8%, or 57.5 million, of the U.S. population, and this group is expected to double within the next 4 decades, the investigators wrote. A few prior studies on the roles of sleep disorders in the cardiometabolic health of Latinos, though suggestive, were limited by cross-sectional designs, relatively small samples, and underrepresentation of various Latino heritage groups.
The investigators on this new study worked with data from the federal Hispanic Community Health Study/Study of Latinos (HCHS/SOL) in which more than 16,000 people participated.
This multiyear federal study drew people who self-identified with different heritage groups, including Cuban, Dominican, Mexican, Central American, South American, and Puerto Rican. Participants initially aged 18-74 years underwent a first round of exams and assessments between 2008 and 2011 to determine what risk factors they had at the start of the study. In the second phase, which took place from 2013 to 2018, participants had a second set of exams. The National Heart, Lung, and Blood Institute and the National Institute of Diabetes and Digestive and Kidney Diseases funded the HCHS/SOL.
The investigators initially had a potential data pool of 11,623 participants in the HCHS/SOL. About 1 of 8 in this group, or 1,424 participants (12.3%), did not undergo a sleep study or did not have sufficient sleep data for analyses. Another 93 (0.8%) participants were excluded for missing data on covariates.
For incident hypertension analyses, participants who had prevalent hypertension at the first screening in the HCHS/SOL (n = 3,139) or had missing data on hypertension (n = 2) were excluded. That resulted in an analytic sample of 6,965 for hypertension questions.
For incident diabetes analyses, participants who had prevalent diabetes at the first screening (n = 2,062) or had missing data on diabetes (n = 21) were excluded, yielding an analytic sample of 8,023.
Incident hypertension was defined as participants not having hypertension at baseline and having hypertension, defined as a systolic blood pressure 140 mm Hg or greater, diastolic blood pressure 90 mm Hg or greater, or receiving antihypertensive medication within 4 weeks, at the second round of screening.
Cardiometabolic disease definitions
The researchers did not discriminate between type 1 and type 2 diabetes. They used the American Diabetes Association definition as a fasting plasma glucose 126 mg/dL or greater, 2-hour, postload plasma glucose 200 mg/dL or greater, or hemoglobin A1c 6.5% or greater, with an additional criterion on self-reported use of antidiabetic medication within 4 weeks before the visit.
In line with previous research, the investigators controlled for potential confounders measured at baseline including sociodemographic factors, health behaviors, and adiposity, which are considered important risk factors for both sleep disorders and incident metabolic diseases. These factors include education level, age, gender, and body mass index and whether participants had ever been smokers or users of alcohol.
Study limitations
Limitations of the study include use of a home sleep apnea test device that did not allow evaluation of arousal or sleep architecture. The researchers said this may have led to an underestimation of disease severity both due to overestimation of sleep time and underrecognition of hypopneas unassociated with desaturation. In addition, prior research has suggested that minority populations might underreport sleep disturbances, possibly “due to social desirability (a tendency not to encode a negative event), stress, stereotype threat, acculturation, attitudes, etc.” The participants were recruited mostly from urban areas, and the results might not be generalized to rural populations. In addition, 41% of study participants were of Mexican heritage, compared with 63% of the Hispanic population being of Mexican heritage in the United States.
Another researcher in the field of health disparities, Julia Roncoroni, PhD, assistant professor of psychology at the University of Denver, also noted this slight underrepresentation of Hispanics of Mexican origin and an overrepresentation of urban individuals in the HCHS/SOL.
“However, using data from HCHS/SOL, which is the largest multicenter epidemiological study of cardiovascular risk factors and sleep traits in U.S. Hispanics/Latinx, allows researchers to answer a high-impact question that would otherwise be prohibitively expensive and time consuming,” wrote Dr. Roncoroni.
Conclusions
The study offers “the first prospective evidence on the associations between SDB and insomnia with incident hypertension and diabetes in US Hispanics/Latinos.” The investigators concluded: “Given the fact that sleep disorders are largely undiagnosed and undertreated, they might represent modifiable targets for disease prevention and reduction among US Hispanics/Latinos. Culturally informed interventions focusing on detecting and treating sleep disorders might improve cardiometabolic health among US Hispanics/Latinos.”
Dr. Redline was partially supported by NIH grant R35 HL135818. This study drew from the Hispanic Community Health Study/Study of Latinos, which has been supported by contracts from the National Heart, Lung, and Blood Institute.
SOURCE: Li X et al. Am J Respir Crit Care Med. 2020 Aug 6. doi: 10.1164/rccm.201912-2330OC.
FROM THE AMERICAN JOURNAL OF RESPIRATORY AND CRITICAL CARE MEDICINE
CMS sticks with E/M pay plan over some objections
The Trump administration is sticking with a plan to boost certain Medicare pay for many primary care and other specialties focused heavily on office visits while lowering that for other groups to balance these increased costs.
On Aug. 4, the Centers for Medicare & Medicaid Services posted on the Federal Register draft versions of two of its major annual payment measures: the physician fee schedule and the payment rule for hospital outpatient and ambulatory surgery center services. On Aug. 3, the CMS informally posted a copy of the physician fee schedule on its own website, allowing medical groups to begin reading the more than 1,300-page rule.
Federal officials normally use annual Medicare payment rules to make many revisions to policies as well as adjust reimbursement.
The draft 2021 physician fee schedule, for example, calls for broadening the authority of clinicians other than physicians to authorize testing of people enrolled in Medicare.
The CMS intends to allow nurse practitioners, physician assistants, and certain other health care professionals to more widely supervise diagnostic psychological and neuropsychological tests.
The draft 2021 hospital outpatient rule proposes a gradual changeover to allow more procedures to be performed on an outpatient basis. This shift could save money for Medicare as well as for the people enrolled in the giant federal health program who need these services, the CMS explained.
Medicare would begin with a change in status for almost 300 musculoskeletal-related services, making them eligible for payment in the hospital outpatient setting when appropriate, CMS wrote in a fact sheet.
The initial reaction to Medicare’s proposed 2021 rules centered on its planned redistribution of funds among medical specialties. The CMS had outlined this plan last year. It is part of longstanding efforts to boost pay for primary care specialists and other physicians whose practice centers more around office visits than procedures.
There is broad support in health policy circles for raising pay for these specialties, but there also are strong objections to the cuts the CMS plans to offset the cost of rising pay for some fields.
Susan R. Bailey, MD, president of the American Medical Association, addressed both of these ideas in an AMA news release on the proposed 2021 physician fee schedule. The increase in pay for office visits, covered under evaluation and management services (E/M), stems from recommendations on resource costs from the AMA/Specialty Society RVS Update Committee, Dr. Bailey said.
“Unfortunately, these office visit payment increases, and a multitude of other new CMS proposed payment increases, are required by statute to be offset by payment reductions to other services, through an unsustainable reduction of nearly 11% to the Medicare conversion factor,” Dr. Bailey explained.
In the news release, Dr. Bailey asked Congress to waive Medicare’s budget-neutrality requirements to allow increases without the cuts.
“Physicians are already experiencing substantial economic hardships due to COVID-19, so these pay cuts could not come at a worse time,” she said.
Winners and losers
The CMS details the possible winners and losers in its payment reshuffle in Table 90 of the proposed 2021 physician fee schedule. In the proposed rule, CMS notes in the draft that these figures are based upon estimates of aggregate allowed charges across all services furnished by physicians and other clinicians.
Specialties in line for increases under the 2021 draft rule include allergy/immunology (9%), endocrinology (17%), family practice (13%), geriatrics (4%), hematology/oncology (14%), internal medicine (4%), physician assistants (8%), psychiatry (8%), rheumatology (16%), and urology (8%).
In line for cuts would be anesthesiology (–8%), cardiac surgery (–9%), emergency medicine (–6%), gastroenterology (–5%), general surgery (–7%), infectious disease (–4%), neurosurgery (–7%), physical/occupational therapy (–9%), plastic surgery (–7%), and radiology (–11%).
An umbrella group, the Surgical Care Coalition, had a quick statement ready about the CMS proposal. Writing on behalf of the group was David B. Hoyt, MD, executive director of the American College of Surgeons.
“Today’s proposed rule ignores both patients and the surgeons who care for them. The middle of a pandemic is no time for cuts to any form of health care, but today’s announcement moves ahead as if nothing has changed,” Dr. Hoyt said in the statement. “The Surgical Care Coalition believes no physician should see payment cuts that will reduce patients’ access to care.”
Making a similar request Aug. 4 in a unified statement were the American Physical Therapy Association (APTA), the American Occupational Therapy Association (AOTA), and the American Speech-Language-Hearing Association (ASHA).
“Our organizations call on Congress and CMS to advance well-reasoned fee schedule payment policies and waive budget neutrality,” the groups said.
A version of this article originally appeared on Medscape.com.
We all agree that E/M services have been undercompensated for many years and applaud CMS for increasing their reimbursements, but this does not mean that endoscopic services are suddenly less valuable as a result. Nor does it mean that the work required to perform endoscopic services has declined.
Lawrence R. Kosinski, MD, MBA, AGAF, is the chief medical officer at SonarMD, Chicago. He is also an associate editor for GI & Hepatology News.
We all agree that E/M services have been undercompensated for many years and applaud CMS for increasing their reimbursements, but this does not mean that endoscopic services are suddenly less valuable as a result. Nor does it mean that the work required to perform endoscopic services has declined.
Lawrence R. Kosinski, MD, MBA, AGAF, is the chief medical officer at SonarMD, Chicago. He is also an associate editor for GI & Hepatology News.
We all agree that E/M services have been undercompensated for many years and applaud CMS for increasing their reimbursements, but this does not mean that endoscopic services are suddenly less valuable as a result. Nor does it mean that the work required to perform endoscopic services has declined.
Lawrence R. Kosinski, MD, MBA, AGAF, is the chief medical officer at SonarMD, Chicago. He is also an associate editor for GI & Hepatology News.
The Trump administration is sticking with a plan to boost certain Medicare pay for many primary care and other specialties focused heavily on office visits while lowering that for other groups to balance these increased costs.
On Aug. 4, the Centers for Medicare & Medicaid Services posted on the Federal Register draft versions of two of its major annual payment measures: the physician fee schedule and the payment rule for hospital outpatient and ambulatory surgery center services. On Aug. 3, the CMS informally posted a copy of the physician fee schedule on its own website, allowing medical groups to begin reading the more than 1,300-page rule.
Federal officials normally use annual Medicare payment rules to make many revisions to policies as well as adjust reimbursement.
The draft 2021 physician fee schedule, for example, calls for broadening the authority of clinicians other than physicians to authorize testing of people enrolled in Medicare.
The CMS intends to allow nurse practitioners, physician assistants, and certain other health care professionals to more widely supervise diagnostic psychological and neuropsychological tests.
The draft 2021 hospital outpatient rule proposes a gradual changeover to allow more procedures to be performed on an outpatient basis. This shift could save money for Medicare as well as for the people enrolled in the giant federal health program who need these services, the CMS explained.
Medicare would begin with a change in status for almost 300 musculoskeletal-related services, making them eligible for payment in the hospital outpatient setting when appropriate, CMS wrote in a fact sheet.
The initial reaction to Medicare’s proposed 2021 rules centered on its planned redistribution of funds among medical specialties. The CMS had outlined this plan last year. It is part of longstanding efforts to boost pay for primary care specialists and other physicians whose practice centers more around office visits than procedures.
There is broad support in health policy circles for raising pay for these specialties, but there also are strong objections to the cuts the CMS plans to offset the cost of rising pay for some fields.
Susan R. Bailey, MD, president of the American Medical Association, addressed both of these ideas in an AMA news release on the proposed 2021 physician fee schedule. The increase in pay for office visits, covered under evaluation and management services (E/M), stems from recommendations on resource costs from the AMA/Specialty Society RVS Update Committee, Dr. Bailey said.
“Unfortunately, these office visit payment increases, and a multitude of other new CMS proposed payment increases, are required by statute to be offset by payment reductions to other services, through an unsustainable reduction of nearly 11% to the Medicare conversion factor,” Dr. Bailey explained.
In the news release, Dr. Bailey asked Congress to waive Medicare’s budget-neutrality requirements to allow increases without the cuts.
“Physicians are already experiencing substantial economic hardships due to COVID-19, so these pay cuts could not come at a worse time,” she said.
Winners and losers
The CMS details the possible winners and losers in its payment reshuffle in Table 90 of the proposed 2021 physician fee schedule. In the proposed rule, CMS notes in the draft that these figures are based upon estimates of aggregate allowed charges across all services furnished by physicians and other clinicians.
Specialties in line for increases under the 2021 draft rule include allergy/immunology (9%), endocrinology (17%), family practice (13%), geriatrics (4%), hematology/oncology (14%), internal medicine (4%), physician assistants (8%), psychiatry (8%), rheumatology (16%), and urology (8%).
In line for cuts would be anesthesiology (–8%), cardiac surgery (–9%), emergency medicine (–6%), gastroenterology (–5%), general surgery (–7%), infectious disease (–4%), neurosurgery (–7%), physical/occupational therapy (–9%), plastic surgery (–7%), and radiology (–11%).
An umbrella group, the Surgical Care Coalition, had a quick statement ready about the CMS proposal. Writing on behalf of the group was David B. Hoyt, MD, executive director of the American College of Surgeons.
“Today’s proposed rule ignores both patients and the surgeons who care for them. The middle of a pandemic is no time for cuts to any form of health care, but today’s announcement moves ahead as if nothing has changed,” Dr. Hoyt said in the statement. “The Surgical Care Coalition believes no physician should see payment cuts that will reduce patients’ access to care.”
Making a similar request Aug. 4 in a unified statement were the American Physical Therapy Association (APTA), the American Occupational Therapy Association (AOTA), and the American Speech-Language-Hearing Association (ASHA).
“Our organizations call on Congress and CMS to advance well-reasoned fee schedule payment policies and waive budget neutrality,” the groups said.
A version of this article originally appeared on Medscape.com.
The Trump administration is sticking with a plan to boost certain Medicare pay for many primary care and other specialties focused heavily on office visits while lowering that for other groups to balance these increased costs.
On Aug. 4, the Centers for Medicare & Medicaid Services posted on the Federal Register draft versions of two of its major annual payment measures: the physician fee schedule and the payment rule for hospital outpatient and ambulatory surgery center services. On Aug. 3, the CMS informally posted a copy of the physician fee schedule on its own website, allowing medical groups to begin reading the more than 1,300-page rule.
Federal officials normally use annual Medicare payment rules to make many revisions to policies as well as adjust reimbursement.
The draft 2021 physician fee schedule, for example, calls for broadening the authority of clinicians other than physicians to authorize testing of people enrolled in Medicare.
The CMS intends to allow nurse practitioners, physician assistants, and certain other health care professionals to more widely supervise diagnostic psychological and neuropsychological tests.
The draft 2021 hospital outpatient rule proposes a gradual changeover to allow more procedures to be performed on an outpatient basis. This shift could save money for Medicare as well as for the people enrolled in the giant federal health program who need these services, the CMS explained.
Medicare would begin with a change in status for almost 300 musculoskeletal-related services, making them eligible for payment in the hospital outpatient setting when appropriate, CMS wrote in a fact sheet.
The initial reaction to Medicare’s proposed 2021 rules centered on its planned redistribution of funds among medical specialties. The CMS had outlined this plan last year. It is part of longstanding efforts to boost pay for primary care specialists and other physicians whose practice centers more around office visits than procedures.
There is broad support in health policy circles for raising pay for these specialties, but there also are strong objections to the cuts the CMS plans to offset the cost of rising pay for some fields.
Susan R. Bailey, MD, president of the American Medical Association, addressed both of these ideas in an AMA news release on the proposed 2021 physician fee schedule. The increase in pay for office visits, covered under evaluation and management services (E/M), stems from recommendations on resource costs from the AMA/Specialty Society RVS Update Committee, Dr. Bailey said.
“Unfortunately, these office visit payment increases, and a multitude of other new CMS proposed payment increases, are required by statute to be offset by payment reductions to other services, through an unsustainable reduction of nearly 11% to the Medicare conversion factor,” Dr. Bailey explained.
In the news release, Dr. Bailey asked Congress to waive Medicare’s budget-neutrality requirements to allow increases without the cuts.
“Physicians are already experiencing substantial economic hardships due to COVID-19, so these pay cuts could not come at a worse time,” she said.
Winners and losers
The CMS details the possible winners and losers in its payment reshuffle in Table 90 of the proposed 2021 physician fee schedule. In the proposed rule, CMS notes in the draft that these figures are based upon estimates of aggregate allowed charges across all services furnished by physicians and other clinicians.
Specialties in line for increases under the 2021 draft rule include allergy/immunology (9%), endocrinology (17%), family practice (13%), geriatrics (4%), hematology/oncology (14%), internal medicine (4%), physician assistants (8%), psychiatry (8%), rheumatology (16%), and urology (8%).
In line for cuts would be anesthesiology (–8%), cardiac surgery (–9%), emergency medicine (–6%), gastroenterology (–5%), general surgery (–7%), infectious disease (–4%), neurosurgery (–7%), physical/occupational therapy (–9%), plastic surgery (–7%), and radiology (–11%).
An umbrella group, the Surgical Care Coalition, had a quick statement ready about the CMS proposal. Writing on behalf of the group was David B. Hoyt, MD, executive director of the American College of Surgeons.
“Today’s proposed rule ignores both patients and the surgeons who care for them. The middle of a pandemic is no time for cuts to any form of health care, but today’s announcement moves ahead as if nothing has changed,” Dr. Hoyt said in the statement. “The Surgical Care Coalition believes no physician should see payment cuts that will reduce patients’ access to care.”
Making a similar request Aug. 4 in a unified statement were the American Physical Therapy Association (APTA), the American Occupational Therapy Association (AOTA), and the American Speech-Language-Hearing Association (ASHA).
“Our organizations call on Congress and CMS to advance well-reasoned fee schedule payment policies and waive budget neutrality,” the groups said.
A version of this article originally appeared on Medscape.com.
Medicare sticks with E/M pay plan over some groups’ objections
The Trump administration is sticking with a plan to boost certain Medicare pay for many primary care and other specialties focused heavily on office visits while lowering that for other groups to balance these increased costs.
On Aug. 4, the Centers for Medicare & Medicaid Services posted on the Federal Register draft versions of two of its major annual payment measures: the physician fee schedule and the payment rule for hospital outpatient services. On Aug. 3, the CMS informally posted a copy of the physician fee schedule on its own website, allowing medical groups to begin reading the more than 1,300-page rule.
Federal officials normally use annual Medicare payment rules to make many revisions to policies as well as adjust reimbursement.
The draft 2021 physician fee schedule, for example, calls for broadening the authority of clinicians other than physicians to authorize testing of people enrolled in Medicare.
The CMS intends to allow nurse practitioners, physician assistants, and certain other health care professionals to more widely supervise diagnostic psychological and neuropsychological tests, in keeping with applicable state laws.
The draft 2021 hospital outpatient rule proposes a gradual changeover to allow more procedures to be performed on an outpatient basis. This shift could save money for Medicare as well as for the people enrolled in the giant federal health program who need these services, the CMS explained.
Medicare would begin with a change in status for almost 300 musculoskeletal-related services, making them eligible for payment in the hospital outpatient setting when appropriate, CMS wrote in a fact sheet.
The initial reaction to Medicare’s proposed 2021 rules centered on its planned redistribution of funds among medical specialties. The CMS had outlined this plan last year. It is part of longstanding efforts to boost pay for primary care specialists and other physicians whose practice centers more around office visits than procedures.
There is broad support in health policy circles for raising pay for these specialties, but there also are strong objections to the cuts the CMS plans to offset the cost of rising pay for some fields.
Susan R. Bailey, MD, president of the American Medical Association, addressed both of these ideas in an AMA news release on the proposed 2021 physician fee schedule. The increase in pay for office visits, covered under evaluation and management services (E/M), stems from recommendations on resource costs from the AMA/Specialty Society RVS Update Committee, Dr. Bailey said.
“Unfortunately, these office visit payment increases, and a multitude of other new CMS proposed payment increases, are required by statute to be offset by payment reductions to other services, through an unsustainable reduction of nearly 11% to the Medicare conversion factor,” Dr. Bailey explained.
In the news release, Dr. Bailey asked Congress to waive Medicare’s budget-neutrality requirements to allow increases without the cuts.
“Physicians are already experiencing substantial economic hardships due to COVID-19, so these pay cuts could not come at a worse time,” she said.
Winners and losers
The CMS details the possible winners and losers in its payment reshuffle in Table 90 of the proposed 2021 physician fee schedule. In the proposed rule, CMS notes in the draft that these figures are based upon estimates of aggregate allowed charges across all services furnished by physicians and other clinicians.
“Therefore, they are averages, and may not necessarily be representative of what is happening to the particular services furnished by a single practitioner within any given specialty,” the CMS said.
Specialties in line for increases under the 2021 draft rule include allergy/immunology (9%), endocrinology (17%), family practice (13%), general practice (8%), geriatrics (4%), hematology/oncology (14%), internal medicine (4%), nephrology (6%), physician assistants (8%), psychiatry (8%), rheumatology (16%), and urology (8%).
In line for cuts would be anesthesiology (–8%), cardiac surgery (–9%), emergency medicine (–6%), general surgery (–7%), infectious disease (–4%), neurosurgery (–7%), physical/occupational therapy (–9%), plastic surgery (–7%), radiology (–11%), and thoracic surgery (–8%).
An umbrella group, the Surgical Care Coalition, on Aug. 3 had a quick statement ready about the CMS proposal. Writing on behalf of the group was David B. Hoyt, MD, executive director of the American College of Surgeons.
“Today’s proposed rule ignores both patients and the surgeons who care for them. The middle of a pandemic is no time for cuts to any form of health care, but today’s announcement moves ahead as if nothing has changed,” Hoyt said in the statement. “The Surgical Care Coalition believes no physician should see payment cuts that will reduce patients’ access to care.”
The Surgical Care Coalition already has been asking Congress to waive budget-neutrality requirements. Making a similar request Aug. 4 in a unified statement were the American Physical Therapy Association (APTA), the American Occupational Therapy Association (AOTA), and the American Speech-Language-Hearing Association (ASHA).
“Our organizations call on Congress and CMS to advance well-reasoned fee schedule payment policies and waive budget neutrality,” the groups said. “While APTA, AOTA, and ASHA do not oppose payment increases for primary care physicians, we believe these increases can be implemented without imposing payment reductions on other providers.”
A version of this article originally appeared on Medscape.com.
The Trump administration is sticking with a plan to boost certain Medicare pay for many primary care and other specialties focused heavily on office visits while lowering that for other groups to balance these increased costs.
On Aug. 4, the Centers for Medicare & Medicaid Services posted on the Federal Register draft versions of two of its major annual payment measures: the physician fee schedule and the payment rule for hospital outpatient services. On Aug. 3, the CMS informally posted a copy of the physician fee schedule on its own website, allowing medical groups to begin reading the more than 1,300-page rule.
Federal officials normally use annual Medicare payment rules to make many revisions to policies as well as adjust reimbursement.
The draft 2021 physician fee schedule, for example, calls for broadening the authority of clinicians other than physicians to authorize testing of people enrolled in Medicare.
The CMS intends to allow nurse practitioners, physician assistants, and certain other health care professionals to more widely supervise diagnostic psychological and neuropsychological tests, in keeping with applicable state laws.
The draft 2021 hospital outpatient rule proposes a gradual changeover to allow more procedures to be performed on an outpatient basis. This shift could save money for Medicare as well as for the people enrolled in the giant federal health program who need these services, the CMS explained.
Medicare would begin with a change in status for almost 300 musculoskeletal-related services, making them eligible for payment in the hospital outpatient setting when appropriate, CMS wrote in a fact sheet.
The initial reaction to Medicare’s proposed 2021 rules centered on its planned redistribution of funds among medical specialties. The CMS had outlined this plan last year. It is part of longstanding efforts to boost pay for primary care specialists and other physicians whose practice centers more around office visits than procedures.
There is broad support in health policy circles for raising pay for these specialties, but there also are strong objections to the cuts the CMS plans to offset the cost of rising pay for some fields.
Susan R. Bailey, MD, president of the American Medical Association, addressed both of these ideas in an AMA news release on the proposed 2021 physician fee schedule. The increase in pay for office visits, covered under evaluation and management services (E/M), stems from recommendations on resource costs from the AMA/Specialty Society RVS Update Committee, Dr. Bailey said.
“Unfortunately, these office visit payment increases, and a multitude of other new CMS proposed payment increases, are required by statute to be offset by payment reductions to other services, through an unsustainable reduction of nearly 11% to the Medicare conversion factor,” Dr. Bailey explained.
In the news release, Dr. Bailey asked Congress to waive Medicare’s budget-neutrality requirements to allow increases without the cuts.
“Physicians are already experiencing substantial economic hardships due to COVID-19, so these pay cuts could not come at a worse time,” she said.
Winners and losers
The CMS details the possible winners and losers in its payment reshuffle in Table 90 of the proposed 2021 physician fee schedule. In the proposed rule, CMS notes in the draft that these figures are based upon estimates of aggregate allowed charges across all services furnished by physicians and other clinicians.
“Therefore, they are averages, and may not necessarily be representative of what is happening to the particular services furnished by a single practitioner within any given specialty,” the CMS said.
Specialties in line for increases under the 2021 draft rule include allergy/immunology (9%), endocrinology (17%), family practice (13%), general practice (8%), geriatrics (4%), hematology/oncology (14%), internal medicine (4%), nephrology (6%), physician assistants (8%), psychiatry (8%), rheumatology (16%), and urology (8%).
In line for cuts would be anesthesiology (–8%), cardiac surgery (–9%), emergency medicine (–6%), general surgery (–7%), infectious disease (–4%), neurosurgery (–7%), physical/occupational therapy (–9%), plastic surgery (–7%), radiology (–11%), and thoracic surgery (–8%).
An umbrella group, the Surgical Care Coalition, on Aug. 3 had a quick statement ready about the CMS proposal. Writing on behalf of the group was David B. Hoyt, MD, executive director of the American College of Surgeons.
“Today’s proposed rule ignores both patients and the surgeons who care for them. The middle of a pandemic is no time for cuts to any form of health care, but today’s announcement moves ahead as if nothing has changed,” Hoyt said in the statement. “The Surgical Care Coalition believes no physician should see payment cuts that will reduce patients’ access to care.”
The Surgical Care Coalition already has been asking Congress to waive budget-neutrality requirements. Making a similar request Aug. 4 in a unified statement were the American Physical Therapy Association (APTA), the American Occupational Therapy Association (AOTA), and the American Speech-Language-Hearing Association (ASHA).
“Our organizations call on Congress and CMS to advance well-reasoned fee schedule payment policies and waive budget neutrality,” the groups said. “While APTA, AOTA, and ASHA do not oppose payment increases for primary care physicians, we believe these increases can be implemented without imposing payment reductions on other providers.”
A version of this article originally appeared on Medscape.com.
The Trump administration is sticking with a plan to boost certain Medicare pay for many primary care and other specialties focused heavily on office visits while lowering that for other groups to balance these increased costs.
On Aug. 4, the Centers for Medicare & Medicaid Services posted on the Federal Register draft versions of two of its major annual payment measures: the physician fee schedule and the payment rule for hospital outpatient services. On Aug. 3, the CMS informally posted a copy of the physician fee schedule on its own website, allowing medical groups to begin reading the more than 1,300-page rule.
Federal officials normally use annual Medicare payment rules to make many revisions to policies as well as adjust reimbursement.
The draft 2021 physician fee schedule, for example, calls for broadening the authority of clinicians other than physicians to authorize testing of people enrolled in Medicare.
The CMS intends to allow nurse practitioners, physician assistants, and certain other health care professionals to more widely supervise diagnostic psychological and neuropsychological tests, in keeping with applicable state laws.
The draft 2021 hospital outpatient rule proposes a gradual changeover to allow more procedures to be performed on an outpatient basis. This shift could save money for Medicare as well as for the people enrolled in the giant federal health program who need these services, the CMS explained.
Medicare would begin with a change in status for almost 300 musculoskeletal-related services, making them eligible for payment in the hospital outpatient setting when appropriate, CMS wrote in a fact sheet.
The initial reaction to Medicare’s proposed 2021 rules centered on its planned redistribution of funds among medical specialties. The CMS had outlined this plan last year. It is part of longstanding efforts to boost pay for primary care specialists and other physicians whose practice centers more around office visits than procedures.
There is broad support in health policy circles for raising pay for these specialties, but there also are strong objections to the cuts the CMS plans to offset the cost of rising pay for some fields.
Susan R. Bailey, MD, president of the American Medical Association, addressed both of these ideas in an AMA news release on the proposed 2021 physician fee schedule. The increase in pay for office visits, covered under evaluation and management services (E/M), stems from recommendations on resource costs from the AMA/Specialty Society RVS Update Committee, Dr. Bailey said.
“Unfortunately, these office visit payment increases, and a multitude of other new CMS proposed payment increases, are required by statute to be offset by payment reductions to other services, through an unsustainable reduction of nearly 11% to the Medicare conversion factor,” Dr. Bailey explained.
In the news release, Dr. Bailey asked Congress to waive Medicare’s budget-neutrality requirements to allow increases without the cuts.
“Physicians are already experiencing substantial economic hardships due to COVID-19, so these pay cuts could not come at a worse time,” she said.
Winners and losers
The CMS details the possible winners and losers in its payment reshuffle in Table 90 of the proposed 2021 physician fee schedule. In the proposed rule, CMS notes in the draft that these figures are based upon estimates of aggregate allowed charges across all services furnished by physicians and other clinicians.
“Therefore, they are averages, and may not necessarily be representative of what is happening to the particular services furnished by a single practitioner within any given specialty,” the CMS said.
Specialties in line for increases under the 2021 draft rule include allergy/immunology (9%), endocrinology (17%), family practice (13%), general practice (8%), geriatrics (4%), hematology/oncology (14%), internal medicine (4%), nephrology (6%), physician assistants (8%), psychiatry (8%), rheumatology (16%), and urology (8%).
In line for cuts would be anesthesiology (–8%), cardiac surgery (–9%), emergency medicine (–6%), general surgery (–7%), infectious disease (–4%), neurosurgery (–7%), physical/occupational therapy (–9%), plastic surgery (–7%), radiology (–11%), and thoracic surgery (–8%).
An umbrella group, the Surgical Care Coalition, on Aug. 3 had a quick statement ready about the CMS proposal. Writing on behalf of the group was David B. Hoyt, MD, executive director of the American College of Surgeons.
“Today’s proposed rule ignores both patients and the surgeons who care for them. The middle of a pandemic is no time for cuts to any form of health care, but today’s announcement moves ahead as if nothing has changed,” Hoyt said in the statement. “The Surgical Care Coalition believes no physician should see payment cuts that will reduce patients’ access to care.”
The Surgical Care Coalition already has been asking Congress to waive budget-neutrality requirements. Making a similar request Aug. 4 in a unified statement were the American Physical Therapy Association (APTA), the American Occupational Therapy Association (AOTA), and the American Speech-Language-Hearing Association (ASHA).
“Our organizations call on Congress and CMS to advance well-reasoned fee schedule payment policies and waive budget neutrality,” the groups said. “While APTA, AOTA, and ASHA do not oppose payment increases for primary care physicians, we believe these increases can be implemented without imposing payment reductions on other providers.”
A version of this article originally appeared on Medscape.com.
Lawmakers question mental health disclosure rules
State medical licensing queries criticized
Several federal lawmakers on June 30 questioned state policies that require disclosure of mental health treatment as part of medical licensing applications and renewals, citing concerns about creating barriers to psychiatric care for clinicians.
Mental health–related questions on state medical boards’ licensing applications are especially worrisome with many clinicians, including ED staff, immersed in the physical and emotional challenges involved in treating waves of people with COVID-19, lawmakers said during a hearing of the House Energy and Commerce Committee’s health panel.
“We must consider the mental health of the providers on the front lines of the pandemic,” said Rep. Morgan Griffith, a Virginia Republican.
The issue of state medical boards’ disclosure rules was not on the official agenda for the House Energy and Commerce health subcommittee’s hearing. And there was no discussion of any specific state medical board’s regulations. The Energy and Commerce health subcommittee is working on more than 20 bills related to mental health, including measures intended to aid first responders, such as firemen and emergency medical personnel, and students.
This hearing marked an early stage in the process for a planned package of mental health legislation, said Rep. Michael C. Burgess, MD, of Texas, who is the top Republican on the Energy and Commerce health subcommittee. There may be opportunities as this legislation advances to add provisions intended to aid physicians, said Dr. Burgess, who practiced for many years as an ob.gyn. before being elected to Congress.
“We knew that suicide was a problem among our colleagues prior to the onset of this coronavirus epidemic and I know it is more pronounced now,” he said.
Dr. Burgess then solicited specific recommendations from the hearing’s witnesses on steps needed to help clinicians’ mental health.
The first suggestion offered in reply by Jeffrey L. Geller, MD, MPH, appearing in his role as president of the American Psychiatric Association, was that Congress should look for ways to encourage states to alter their licensing procedures.
The hearing comes on the heels of the APA, the American Academy of Family Physicians, and more than 40 other groups having jointly signed a statement calling for changes to disclosure rules about mental health.
“Licensing and credentialing applications by covered entities should only employ narrowly focused questions that address current functional impairment,” the statement said. “Additionally, we strongly support The Joint Commission (TJC) statement on Removing Barriers to Mental Health Care for Clinicians and Health Care Staff. TJC ‘supports the removal of any barriers that inhibit clinicians and health care staff from accessing mental health care services.’ ”
Physicians and other clinicians must be able to safely secure treatment for mental or other health issues, just as any other individual,” the groups wrote. “A provider’s history of mental illness or substance use disorder should not be used as any indication of their current or future ability to practice competently and without impairment.”
Also among the signers to this statement was the Federation of State Medical Boards, which has been leading an effort for years to change licensing.
In 2018, the FSMB recommended state medical boards reconsider whether it is necessary to include probing questions about a physician applicant’s mental health, addiction, or substance use on applications for medical licensure or their renewal. While the intent of these questions may be to protect patients, these queries can discourage physicians from getting needed help, the FSMB said.
Several states have since revised or considered revising their license applications and renewals. In May 2020, The Joint Commission urged broader adoption of recommendations from the FSMB and the American Medical Association to limit queries about clinicians’ mental health to “conditions that currently impair the clinicians’ ability to perform their job.”
“We strongly encourage organizations to not ask about past history of mental health conditions or treatment,” said The Joint Commission, which accredits hospitals, in a statement. “It is critical that we ensure health care workers can feel free to access mental health resources.”
Rep. Susan Brooks, an Indiana Republican who is an attorney, suggested there may need to be a broader look at how state officials pose questions about past mental health treatment to people in many professions, including her own.
“It does build on the stigma on accessing services” to know a state or licensing authority may question a professional about receiving treatment for mental health, she said.
Also at the hearing, Rep. Nanette Diaz Barragán, a California Democrat, spoke of her own reaction to seeing a question about mental health treatment while applying for a White House internship. During her college years, Rep. Barragán had to cope with her father’s terminal illness.
“I remember thinking to myself: ‘Jeez, if I end up seeing a mental health expert maybe one day I couldn’t work in government,’ ” she said.
State medical licensing queries criticized
State medical licensing queries criticized
Several federal lawmakers on June 30 questioned state policies that require disclosure of mental health treatment as part of medical licensing applications and renewals, citing concerns about creating barriers to psychiatric care for clinicians.
Mental health–related questions on state medical boards’ licensing applications are especially worrisome with many clinicians, including ED staff, immersed in the physical and emotional challenges involved in treating waves of people with COVID-19, lawmakers said during a hearing of the House Energy and Commerce Committee’s health panel.
“We must consider the mental health of the providers on the front lines of the pandemic,” said Rep. Morgan Griffith, a Virginia Republican.
The issue of state medical boards’ disclosure rules was not on the official agenda for the House Energy and Commerce health subcommittee’s hearing. And there was no discussion of any specific state medical board’s regulations. The Energy and Commerce health subcommittee is working on more than 20 bills related to mental health, including measures intended to aid first responders, such as firemen and emergency medical personnel, and students.
This hearing marked an early stage in the process for a planned package of mental health legislation, said Rep. Michael C. Burgess, MD, of Texas, who is the top Republican on the Energy and Commerce health subcommittee. There may be opportunities as this legislation advances to add provisions intended to aid physicians, said Dr. Burgess, who practiced for many years as an ob.gyn. before being elected to Congress.
“We knew that suicide was a problem among our colleagues prior to the onset of this coronavirus epidemic and I know it is more pronounced now,” he said.
Dr. Burgess then solicited specific recommendations from the hearing’s witnesses on steps needed to help clinicians’ mental health.
The first suggestion offered in reply by Jeffrey L. Geller, MD, MPH, appearing in his role as president of the American Psychiatric Association, was that Congress should look for ways to encourage states to alter their licensing procedures.
The hearing comes on the heels of the APA, the American Academy of Family Physicians, and more than 40 other groups having jointly signed a statement calling for changes to disclosure rules about mental health.
“Licensing and credentialing applications by covered entities should only employ narrowly focused questions that address current functional impairment,” the statement said. “Additionally, we strongly support The Joint Commission (TJC) statement on Removing Barriers to Mental Health Care for Clinicians and Health Care Staff. TJC ‘supports the removal of any barriers that inhibit clinicians and health care staff from accessing mental health care services.’ ”
Physicians and other clinicians must be able to safely secure treatment for mental or other health issues, just as any other individual,” the groups wrote. “A provider’s history of mental illness or substance use disorder should not be used as any indication of their current or future ability to practice competently and without impairment.”
Also among the signers to this statement was the Federation of State Medical Boards, which has been leading an effort for years to change licensing.
In 2018, the FSMB recommended state medical boards reconsider whether it is necessary to include probing questions about a physician applicant’s mental health, addiction, or substance use on applications for medical licensure or their renewal. While the intent of these questions may be to protect patients, these queries can discourage physicians from getting needed help, the FSMB said.
Several states have since revised or considered revising their license applications and renewals. In May 2020, The Joint Commission urged broader adoption of recommendations from the FSMB and the American Medical Association to limit queries about clinicians’ mental health to “conditions that currently impair the clinicians’ ability to perform their job.”
“We strongly encourage organizations to not ask about past history of mental health conditions or treatment,” said The Joint Commission, which accredits hospitals, in a statement. “It is critical that we ensure health care workers can feel free to access mental health resources.”
Rep. Susan Brooks, an Indiana Republican who is an attorney, suggested there may need to be a broader look at how state officials pose questions about past mental health treatment to people in many professions, including her own.
“It does build on the stigma on accessing services” to know a state or licensing authority may question a professional about receiving treatment for mental health, she said.
Also at the hearing, Rep. Nanette Diaz Barragán, a California Democrat, spoke of her own reaction to seeing a question about mental health treatment while applying for a White House internship. During her college years, Rep. Barragán had to cope with her father’s terminal illness.
“I remember thinking to myself: ‘Jeez, if I end up seeing a mental health expert maybe one day I couldn’t work in government,’ ” she said.
Several federal lawmakers on June 30 questioned state policies that require disclosure of mental health treatment as part of medical licensing applications and renewals, citing concerns about creating barriers to psychiatric care for clinicians.
Mental health–related questions on state medical boards’ licensing applications are especially worrisome with many clinicians, including ED staff, immersed in the physical and emotional challenges involved in treating waves of people with COVID-19, lawmakers said during a hearing of the House Energy and Commerce Committee’s health panel.
“We must consider the mental health of the providers on the front lines of the pandemic,” said Rep. Morgan Griffith, a Virginia Republican.
The issue of state medical boards’ disclosure rules was not on the official agenda for the House Energy and Commerce health subcommittee’s hearing. And there was no discussion of any specific state medical board’s regulations. The Energy and Commerce health subcommittee is working on more than 20 bills related to mental health, including measures intended to aid first responders, such as firemen and emergency medical personnel, and students.
This hearing marked an early stage in the process for a planned package of mental health legislation, said Rep. Michael C. Burgess, MD, of Texas, who is the top Republican on the Energy and Commerce health subcommittee. There may be opportunities as this legislation advances to add provisions intended to aid physicians, said Dr. Burgess, who practiced for many years as an ob.gyn. before being elected to Congress.
“We knew that suicide was a problem among our colleagues prior to the onset of this coronavirus epidemic and I know it is more pronounced now,” he said.
Dr. Burgess then solicited specific recommendations from the hearing’s witnesses on steps needed to help clinicians’ mental health.
The first suggestion offered in reply by Jeffrey L. Geller, MD, MPH, appearing in his role as president of the American Psychiatric Association, was that Congress should look for ways to encourage states to alter their licensing procedures.
The hearing comes on the heels of the APA, the American Academy of Family Physicians, and more than 40 other groups having jointly signed a statement calling for changes to disclosure rules about mental health.
“Licensing and credentialing applications by covered entities should only employ narrowly focused questions that address current functional impairment,” the statement said. “Additionally, we strongly support The Joint Commission (TJC) statement on Removing Barriers to Mental Health Care for Clinicians and Health Care Staff. TJC ‘supports the removal of any barriers that inhibit clinicians and health care staff from accessing mental health care services.’ ”
Physicians and other clinicians must be able to safely secure treatment for mental or other health issues, just as any other individual,” the groups wrote. “A provider’s history of mental illness or substance use disorder should not be used as any indication of their current or future ability to practice competently and without impairment.”
Also among the signers to this statement was the Federation of State Medical Boards, which has been leading an effort for years to change licensing.
In 2018, the FSMB recommended state medical boards reconsider whether it is necessary to include probing questions about a physician applicant’s mental health, addiction, or substance use on applications for medical licensure or their renewal. While the intent of these questions may be to protect patients, these queries can discourage physicians from getting needed help, the FSMB said.
Several states have since revised or considered revising their license applications and renewals. In May 2020, The Joint Commission urged broader adoption of recommendations from the FSMB and the American Medical Association to limit queries about clinicians’ mental health to “conditions that currently impair the clinicians’ ability to perform their job.”
“We strongly encourage organizations to not ask about past history of mental health conditions or treatment,” said The Joint Commission, which accredits hospitals, in a statement. “It is critical that we ensure health care workers can feel free to access mental health resources.”
Rep. Susan Brooks, an Indiana Republican who is an attorney, suggested there may need to be a broader look at how state officials pose questions about past mental health treatment to people in many professions, including her own.
“It does build on the stigma on accessing services” to know a state or licensing authority may question a professional about receiving treatment for mental health, she said.
Also at the hearing, Rep. Nanette Diaz Barragán, a California Democrat, spoke of her own reaction to seeing a question about mental health treatment while applying for a White House internship. During her college years, Rep. Barragán had to cope with her father’s terminal illness.
“I remember thinking to myself: ‘Jeez, if I end up seeing a mental health expert maybe one day I couldn’t work in government,’ ” she said.
FROM A HOUSE ENERGY AND COMMERCE’S HEALTH SUBCOMMITTEE HEARING
Blood test detects colon cancer in single-center study
Blood assay studied for colorectal cancer screening.
A blood test detected 11 of 11 cases of colorectal cancer in a study involving 354 patients, and also spotted a majority of cases – 40 out of 53 – in which participants had advanced adenomas, an investigator said.
Results from a single-center study of CellMax Life’s FirstSight blood test were released as a poster as part of the annual Digestive Disease Week®, which was canceled because of COVID-19.
For a study conducted at one site, the Veterans Affairs Palo Alto (Calif.) Healthcare System, Shai Friedland, MD, and colleagues recruited 354 patients between ages 45 and 80 who were scheduled for elective colonoscopy. The researchers excluded people with a personal history of cancer or inflammatory bowel disease. They used CellMax’s FirstSight test on blood samples from the study participants.
The FirstSight test result was positive for colorectal cancer in all 11 patients in the study who were found by colonoscopy to have this condition, said Dr. Friedland, who is a professor of medicine at Stanford (Calif.) University and chief of gastroenterology at the VA Palo Alto Healthcare System. Thus, the test showed a sensitivity of 100% in this instance.
Among the 53 study participants found by colonoscopy to have advanced adenoma, 40 were positive on FirstSight; thus, so the test has a sensitivity of 75.5% for this result.
Among 79 patients who had negative colonoscopy results, meaning they were judged free of cancer or polyps, the test showed 8 as having signs of disease or growths.
“If you had a large adenoma that was removed years ago and now you have a negative colonoscopy, your score might still be high,” Dr. Friedland said in a recorded presentation for DDW. “In other words, the changes that are detectable in your blood might persist even after the polypectomy.”
He said there are plans to soon start a large-scale multicenter study of the CellMax assay.
“The blood test has the potential to fill an unmet need by giving patients a highly sensitive convenient option for colorectal cancer screening,” he said.
CellMax already is seeking to position its test as a more convenient alternative to either colonoscopy or the Cologuard screening test. Many patients put off cancer screening because of the need to take time off from work and the invasive nature of colonoscopy. Exact Sciences has used direct-to-consumer advertising to promote its Cologuard home-based test as a more convenient alternative to colonoscopy, but its product requires patients to collect their own stool samples and mail them to a lab, a process many people find off-putting.
Public health advocates, including the U.S. Preventive Services Task Force (USPSTF), have for years been pressing for wider screening of American adults for colon cancer. USPSTF is in the midst of updating its recommendations on colon cancer. In announcing its latest update of these recommendations in 2016, USPSTF said “the best screening test is the one that gets done” (JAMA. 2016;315[23]:2564-75).
USPSTF pressed for maximizing the total proportion of the eligible population, a point Dr. Friedland echoed in a CellMax press release.
“For colon cancer screening to be most effective, it is essential to detect precancerous polyps and then perform a colonoscopy to remove the polyps,” said Dr. Friedland in the CellMax press release. “Giving patients the option of getting a blood test for screening would undoubtedly increase compliance and thereby reduce mortality from colorectal cancer.”
In the DDW presentation, Dr. Friedland and colleagues also said the CellMax test showed greater sensitivity (100%) for colorectal cancer and advanced precancerous lesions (75.5%) than did Cologuard (92.3% for colorectal cancer and 42.4% for advanced precancerous lesions).
Cara Connelly, Director of Public Relations and Corporate Communications for Exact Sciences said that the company “is dedicated to getting more people screened for colorectal cancer and applaud the researchers for their efforts. We look forward to hearing more about the performance of this test in a prospective multisite study with nonsymptomatic patients.”
Naresh T. Gunaratnam, MD, a gastroenterologist and research director at Huron Gastro in Ypsilanti, Mich., said he is concerned that aggressive promotion of alternative tests may obscure the benefits of colonoscopy. Dr. Gunaratnam, a 2019 winner of the American Gastroenterological Association (AGA) Distinguished Clinician Award, has been a public critic of the marketing of colon cancer tests, which emphasize the convenience of these products. When asked by MDedge to comment on the CellMax-funded study, Dr. Gunaratnam said alternative tests do have a place for the care of patients who cannot or will not have a colonoscopy.
“But if you convince a patient who would be willing to have a colonoscopy not to, that’s a disservice,” he said.
“If you want the best test, the one that is best at finding cancers and finding polyps and the only one that can remove the polyp, that’s colonoscopy,” Dr. Gunaratnam added. “One day there may be a pill you can swallow that blows up the polyps, but we’re not there yet. We have to mechanically remove them.”
SOURCE: Friedland S et al. DDW 2020, eposter 575.
Blood assay studied for colorectal cancer screening.
Blood assay studied for colorectal cancer screening.
A blood test detected 11 of 11 cases of colorectal cancer in a study involving 354 patients, and also spotted a majority of cases – 40 out of 53 – in which participants had advanced adenomas, an investigator said.
Results from a single-center study of CellMax Life’s FirstSight blood test were released as a poster as part of the annual Digestive Disease Week®, which was canceled because of COVID-19.
For a study conducted at one site, the Veterans Affairs Palo Alto (Calif.) Healthcare System, Shai Friedland, MD, and colleagues recruited 354 patients between ages 45 and 80 who were scheduled for elective colonoscopy. The researchers excluded people with a personal history of cancer or inflammatory bowel disease. They used CellMax’s FirstSight test on blood samples from the study participants.
The FirstSight test result was positive for colorectal cancer in all 11 patients in the study who were found by colonoscopy to have this condition, said Dr. Friedland, who is a professor of medicine at Stanford (Calif.) University and chief of gastroenterology at the VA Palo Alto Healthcare System. Thus, the test showed a sensitivity of 100% in this instance.
Among the 53 study participants found by colonoscopy to have advanced adenoma, 40 were positive on FirstSight; thus, so the test has a sensitivity of 75.5% for this result.
Among 79 patients who had negative colonoscopy results, meaning they were judged free of cancer or polyps, the test showed 8 as having signs of disease or growths.
“If you had a large adenoma that was removed years ago and now you have a negative colonoscopy, your score might still be high,” Dr. Friedland said in a recorded presentation for DDW. “In other words, the changes that are detectable in your blood might persist even after the polypectomy.”
He said there are plans to soon start a large-scale multicenter study of the CellMax assay.
“The blood test has the potential to fill an unmet need by giving patients a highly sensitive convenient option for colorectal cancer screening,” he said.
CellMax already is seeking to position its test as a more convenient alternative to either colonoscopy or the Cologuard screening test. Many patients put off cancer screening because of the need to take time off from work and the invasive nature of colonoscopy. Exact Sciences has used direct-to-consumer advertising to promote its Cologuard home-based test as a more convenient alternative to colonoscopy, but its product requires patients to collect their own stool samples and mail them to a lab, a process many people find off-putting.
Public health advocates, including the U.S. Preventive Services Task Force (USPSTF), have for years been pressing for wider screening of American adults for colon cancer. USPSTF is in the midst of updating its recommendations on colon cancer. In announcing its latest update of these recommendations in 2016, USPSTF said “the best screening test is the one that gets done” (JAMA. 2016;315[23]:2564-75).
USPSTF pressed for maximizing the total proportion of the eligible population, a point Dr. Friedland echoed in a CellMax press release.
“For colon cancer screening to be most effective, it is essential to detect precancerous polyps and then perform a colonoscopy to remove the polyps,” said Dr. Friedland in the CellMax press release. “Giving patients the option of getting a blood test for screening would undoubtedly increase compliance and thereby reduce mortality from colorectal cancer.”
In the DDW presentation, Dr. Friedland and colleagues also said the CellMax test showed greater sensitivity (100%) for colorectal cancer and advanced precancerous lesions (75.5%) than did Cologuard (92.3% for colorectal cancer and 42.4% for advanced precancerous lesions).
Cara Connelly, Director of Public Relations and Corporate Communications for Exact Sciences said that the company “is dedicated to getting more people screened for colorectal cancer and applaud the researchers for their efforts. We look forward to hearing more about the performance of this test in a prospective multisite study with nonsymptomatic patients.”
Naresh T. Gunaratnam, MD, a gastroenterologist and research director at Huron Gastro in Ypsilanti, Mich., said he is concerned that aggressive promotion of alternative tests may obscure the benefits of colonoscopy. Dr. Gunaratnam, a 2019 winner of the American Gastroenterological Association (AGA) Distinguished Clinician Award, has been a public critic of the marketing of colon cancer tests, which emphasize the convenience of these products. When asked by MDedge to comment on the CellMax-funded study, Dr. Gunaratnam said alternative tests do have a place for the care of patients who cannot or will not have a colonoscopy.
“But if you convince a patient who would be willing to have a colonoscopy not to, that’s a disservice,” he said.
“If you want the best test, the one that is best at finding cancers and finding polyps and the only one that can remove the polyp, that’s colonoscopy,” Dr. Gunaratnam added. “One day there may be a pill you can swallow that blows up the polyps, but we’re not there yet. We have to mechanically remove them.”
SOURCE: Friedland S et al. DDW 2020, eposter 575.
A blood test detected 11 of 11 cases of colorectal cancer in a study involving 354 patients, and also spotted a majority of cases – 40 out of 53 – in which participants had advanced adenomas, an investigator said.
Results from a single-center study of CellMax Life’s FirstSight blood test were released as a poster as part of the annual Digestive Disease Week®, which was canceled because of COVID-19.
For a study conducted at one site, the Veterans Affairs Palo Alto (Calif.) Healthcare System, Shai Friedland, MD, and colleagues recruited 354 patients between ages 45 and 80 who were scheduled for elective colonoscopy. The researchers excluded people with a personal history of cancer or inflammatory bowel disease. They used CellMax’s FirstSight test on blood samples from the study participants.
The FirstSight test result was positive for colorectal cancer in all 11 patients in the study who were found by colonoscopy to have this condition, said Dr. Friedland, who is a professor of medicine at Stanford (Calif.) University and chief of gastroenterology at the VA Palo Alto Healthcare System. Thus, the test showed a sensitivity of 100% in this instance.
Among the 53 study participants found by colonoscopy to have advanced adenoma, 40 were positive on FirstSight; thus, so the test has a sensitivity of 75.5% for this result.
Among 79 patients who had negative colonoscopy results, meaning they were judged free of cancer or polyps, the test showed 8 as having signs of disease or growths.
“If you had a large adenoma that was removed years ago and now you have a negative colonoscopy, your score might still be high,” Dr. Friedland said in a recorded presentation for DDW. “In other words, the changes that are detectable in your blood might persist even after the polypectomy.”
He said there are plans to soon start a large-scale multicenter study of the CellMax assay.
“The blood test has the potential to fill an unmet need by giving patients a highly sensitive convenient option for colorectal cancer screening,” he said.
CellMax already is seeking to position its test as a more convenient alternative to either colonoscopy or the Cologuard screening test. Many patients put off cancer screening because of the need to take time off from work and the invasive nature of colonoscopy. Exact Sciences has used direct-to-consumer advertising to promote its Cologuard home-based test as a more convenient alternative to colonoscopy, but its product requires patients to collect their own stool samples and mail them to a lab, a process many people find off-putting.
Public health advocates, including the U.S. Preventive Services Task Force (USPSTF), have for years been pressing for wider screening of American adults for colon cancer. USPSTF is in the midst of updating its recommendations on colon cancer. In announcing its latest update of these recommendations in 2016, USPSTF said “the best screening test is the one that gets done” (JAMA. 2016;315[23]:2564-75).
USPSTF pressed for maximizing the total proportion of the eligible population, a point Dr. Friedland echoed in a CellMax press release.
“For colon cancer screening to be most effective, it is essential to detect precancerous polyps and then perform a colonoscopy to remove the polyps,” said Dr. Friedland in the CellMax press release. “Giving patients the option of getting a blood test for screening would undoubtedly increase compliance and thereby reduce mortality from colorectal cancer.”
In the DDW presentation, Dr. Friedland and colleagues also said the CellMax test showed greater sensitivity (100%) for colorectal cancer and advanced precancerous lesions (75.5%) than did Cologuard (92.3% for colorectal cancer and 42.4% for advanced precancerous lesions).
Cara Connelly, Director of Public Relations and Corporate Communications for Exact Sciences said that the company “is dedicated to getting more people screened for colorectal cancer and applaud the researchers for their efforts. We look forward to hearing more about the performance of this test in a prospective multisite study with nonsymptomatic patients.”
Naresh T. Gunaratnam, MD, a gastroenterologist and research director at Huron Gastro in Ypsilanti, Mich., said he is concerned that aggressive promotion of alternative tests may obscure the benefits of colonoscopy. Dr. Gunaratnam, a 2019 winner of the American Gastroenterological Association (AGA) Distinguished Clinician Award, has been a public critic of the marketing of colon cancer tests, which emphasize the convenience of these products. When asked by MDedge to comment on the CellMax-funded study, Dr. Gunaratnam said alternative tests do have a place for the care of patients who cannot or will not have a colonoscopy.
“But if you convince a patient who would be willing to have a colonoscopy not to, that’s a disservice,” he said.
“If you want the best test, the one that is best at finding cancers and finding polyps and the only one that can remove the polyp, that’s colonoscopy,” Dr. Gunaratnam added. “One day there may be a pill you can swallow that blows up the polyps, but we’re not there yet. We have to mechanically remove them.”
SOURCE: Friedland S et al. DDW 2020, eposter 575.
FROM DDW 2020
Ranitidine did not show higher cancer risk than famotidine in study
People who had taken either of these drugs had a higher risk for cancer, but they also were more likely to have risk factors for this disease such as obesity or a history of smoking, an investigator said.
The findings from Nabeeha Mohyuddin, MD, an internal medicine resident at Allegheny Health Network in Pittsburgh, appear to be at odds with warnings from the U.S. Food and Drug Administration. The FDA in April called on manufacturers to pull all versions of ranitidine because of a problem with probable contamination by human carcinogen n-nitrosodimethylamine (NDMA). The FDA and the European Medicines Agency last year announced investigations of this NDMA contamination.
Dr. Mohyuddin and colleagues used IBM’s Explorys database, which includes data collected from EMRs from more than 40 U.S. health systems, to see if ranitidine use appeared connected to cancer diagnoses. Dr. Mohyuddin presented the findings in an abstract released as part of the annual Digestive Disease Week®, which was canceled because of COVID-19. The researchers identified records for 1.62 million users of ranitidine, 3.37 million users of famotidine, and 59.63 million people who did not use either H2 blocker.
The incidence of cancer was respectively 14.69%, 21.24%, and 5.38% for the ranitidine group, the famotidine group, and the group representing the general population without use of either H2 blocker. Among subjects without risk factors including smoking, obesity, alcohol use, family history, cirrhosis, and gastroesophageal reflux disease, ranitidine users did not have an increased risk of cancer, compared with famotidine users (odds ratio, 0.77; 95% confidence interval, 0.76-0.77; P < .001), Dr. Mohyuddin said in an email interview after her presentation.
“The results need to be interpreted with caution given that this is a retrospective study and it’s the first of its kind,” she said. “Further studies will be definitely needed on this to definitively answer the question, ‘does ranitidine have an increased risk of cancer?’ ”
People in the study who used H2 blockers tended to be older and were more likely to have other risk factors for cancers, according to the abstract:
- Of the ranitidine group, about 33.6% were older than 65, 74.4% were smokers, and 8.9% had a body mass index above 30 kg/m2.
- Of the famotidine group, about 38.3% were older than 65, 76.9% were smokers and 10.8% had a BMI above 30.
- Of the general population, about 23.9% were older than 65, 27.5% were smokers, and 1.69% were obese.
The Explorys database accounts for only 15%-19% of the entire U.S. population and that could be an explanation for why the percentage for obesity in the population seems spuriously low, Dr. Mohyuddin said in an email exchange.
Additionally, it pulls in patients through diagnosis codes, and if a different code for obesity was entered, those patients may not have been accounted for, she said.
Dhyanesh A. Patel, MD, assistant professor of medicine at Vanderbilt University, Nashville, Tenn., said it was a surprise to see the rate of cancer reported for famotidine users in the abstract presented at DDW.
“But these databases are so prone to multiple biases that it’s really hard to tease out. You’d really have to do prospective studies where you follow these patients and then control for variables to know the true risk,” Dr. Patel said in an interview.
In many cases, for example, patients may start on H2 blockers after reporting symptoms that sound like indigestion, Patel said.
“And then the next week, they actually get an upper endoscopy and they get diagnosed with gastric cancer,” Patel said. “In the database, it may seem to be that ranitidine was started and the patient was diagnosed with gastric cancer. So now the gastric cancer gets associated with ranitidine.”
Physicians have had many options to use instead of ranitidine since the FDA last year announced its concerns about the drug, Dr. Patel said.
“Patients can easily switch over to a similar histamine blocker or you can use one of the proton pump inhibitors that haven’t been found to have this impurity in them,” he said. “Both of those are good options for patients.”
Further research
Manufacturers have been withdrawing their ranitidine products from the market since the reports of contamination surfaced last year. Several drugmakers, including Pfizer and Perrigo, have reported facing lawsuits connected with claims of cancer or increased cancer risk from ranitidine. In February 2020, a federal judicial panel opted to use a procedure, known as multidistrict litigation (MDL), to streamline the handling of these many cases. They were put before the U.S. District Court for the Southern District of Florida, labeled as In Re: Zantac (Ranitidine) NDMA Litigation.
A spokesman for FDA declined MDedge’s request for comment on Dr. Mohyuddin’s DDW presentation. He said the agency tends not to offer its views on work done by scientists outside of the FDA.
Valisure, an online pharmacy that runs quality checks on the medicines it dispenses, in September 2019 petitioned the FDA for a withdrawal of ranitidine due to concerns about NDMA. In its petition, Valisure reported finding notable levels of NDMA in ranitidine tablets, but not detecting it in testing of famotidine and several similar drugs. In an emailed statement, David Light, founder and CEO of Valisure, said the structure of Dr. Mohyuddin’s research limited its ability to detect cancer correlations because of the large and generalized study population.
“When comparing millions of people on medications which are both over-the-counter and prescription, any epidemiological impact will very likely be eclipsed by the sheer variations of exposure and a wide variety of confounding factors,” Mr. Light wrote.
There are a “vast number of variables that aren’t controlled for in such a massive and broadly defined cohort,” he added.
More focused and controlled studies will be needed to best evaluate NDMA and ranitidine, according to Mr. Light. “We are also investigating this issue with researchers at Memorial Sloan Kettering Cancer Center and plan to publish results soon,” he said.
Dr. Mohyuddin and Dr. Patel did not disclose financial conflicts in connection with ranitidine.
SOURCE: Mohyuddin N et al. DDW 2020. Abstract Tu1360.
People who had taken either of these drugs had a higher risk for cancer, but they also were more likely to have risk factors for this disease such as obesity or a history of smoking, an investigator said.
The findings from Nabeeha Mohyuddin, MD, an internal medicine resident at Allegheny Health Network in Pittsburgh, appear to be at odds with warnings from the U.S. Food and Drug Administration. The FDA in April called on manufacturers to pull all versions of ranitidine because of a problem with probable contamination by human carcinogen n-nitrosodimethylamine (NDMA). The FDA and the European Medicines Agency last year announced investigations of this NDMA contamination.
Dr. Mohyuddin and colleagues used IBM’s Explorys database, which includes data collected from EMRs from more than 40 U.S. health systems, to see if ranitidine use appeared connected to cancer diagnoses. Dr. Mohyuddin presented the findings in an abstract released as part of the annual Digestive Disease Week®, which was canceled because of COVID-19. The researchers identified records for 1.62 million users of ranitidine, 3.37 million users of famotidine, and 59.63 million people who did not use either H2 blocker.
The incidence of cancer was respectively 14.69%, 21.24%, and 5.38% for the ranitidine group, the famotidine group, and the group representing the general population without use of either H2 blocker. Among subjects without risk factors including smoking, obesity, alcohol use, family history, cirrhosis, and gastroesophageal reflux disease, ranitidine users did not have an increased risk of cancer, compared with famotidine users (odds ratio, 0.77; 95% confidence interval, 0.76-0.77; P < .001), Dr. Mohyuddin said in an email interview after her presentation.
“The results need to be interpreted with caution given that this is a retrospective study and it’s the first of its kind,” she said. “Further studies will be definitely needed on this to definitively answer the question, ‘does ranitidine have an increased risk of cancer?’ ”
People in the study who used H2 blockers tended to be older and were more likely to have other risk factors for cancers, according to the abstract:
- Of the ranitidine group, about 33.6% were older than 65, 74.4% were smokers, and 8.9% had a body mass index above 30 kg/m2.
- Of the famotidine group, about 38.3% were older than 65, 76.9% were smokers and 10.8% had a BMI above 30.
- Of the general population, about 23.9% were older than 65, 27.5% were smokers, and 1.69% were obese.
The Explorys database accounts for only 15%-19% of the entire U.S. population and that could be an explanation for why the percentage for obesity in the population seems spuriously low, Dr. Mohyuddin said in an email exchange.
Additionally, it pulls in patients through diagnosis codes, and if a different code for obesity was entered, those patients may not have been accounted for, she said.
Dhyanesh A. Patel, MD, assistant professor of medicine at Vanderbilt University, Nashville, Tenn., said it was a surprise to see the rate of cancer reported for famotidine users in the abstract presented at DDW.
“But these databases are so prone to multiple biases that it’s really hard to tease out. You’d really have to do prospective studies where you follow these patients and then control for variables to know the true risk,” Dr. Patel said in an interview.
In many cases, for example, patients may start on H2 blockers after reporting symptoms that sound like indigestion, Patel said.
“And then the next week, they actually get an upper endoscopy and they get diagnosed with gastric cancer,” Patel said. “In the database, it may seem to be that ranitidine was started and the patient was diagnosed with gastric cancer. So now the gastric cancer gets associated with ranitidine.”
Physicians have had many options to use instead of ranitidine since the FDA last year announced its concerns about the drug, Dr. Patel said.
“Patients can easily switch over to a similar histamine blocker or you can use one of the proton pump inhibitors that haven’t been found to have this impurity in them,” he said. “Both of those are good options for patients.”
Further research
Manufacturers have been withdrawing their ranitidine products from the market since the reports of contamination surfaced last year. Several drugmakers, including Pfizer and Perrigo, have reported facing lawsuits connected with claims of cancer or increased cancer risk from ranitidine. In February 2020, a federal judicial panel opted to use a procedure, known as multidistrict litigation (MDL), to streamline the handling of these many cases. They were put before the U.S. District Court for the Southern District of Florida, labeled as In Re: Zantac (Ranitidine) NDMA Litigation.
A spokesman for FDA declined MDedge’s request for comment on Dr. Mohyuddin’s DDW presentation. He said the agency tends not to offer its views on work done by scientists outside of the FDA.
Valisure, an online pharmacy that runs quality checks on the medicines it dispenses, in September 2019 petitioned the FDA for a withdrawal of ranitidine due to concerns about NDMA. In its petition, Valisure reported finding notable levels of NDMA in ranitidine tablets, but not detecting it in testing of famotidine and several similar drugs. In an emailed statement, David Light, founder and CEO of Valisure, said the structure of Dr. Mohyuddin’s research limited its ability to detect cancer correlations because of the large and generalized study population.
“When comparing millions of people on medications which are both over-the-counter and prescription, any epidemiological impact will very likely be eclipsed by the sheer variations of exposure and a wide variety of confounding factors,” Mr. Light wrote.
There are a “vast number of variables that aren’t controlled for in such a massive and broadly defined cohort,” he added.
More focused and controlled studies will be needed to best evaluate NDMA and ranitidine, according to Mr. Light. “We are also investigating this issue with researchers at Memorial Sloan Kettering Cancer Center and plan to publish results soon,” he said.
Dr. Mohyuddin and Dr. Patel did not disclose financial conflicts in connection with ranitidine.
SOURCE: Mohyuddin N et al. DDW 2020. Abstract Tu1360.
People who had taken either of these drugs had a higher risk for cancer, but they also were more likely to have risk factors for this disease such as obesity or a history of smoking, an investigator said.
The findings from Nabeeha Mohyuddin, MD, an internal medicine resident at Allegheny Health Network in Pittsburgh, appear to be at odds with warnings from the U.S. Food and Drug Administration. The FDA in April called on manufacturers to pull all versions of ranitidine because of a problem with probable contamination by human carcinogen n-nitrosodimethylamine (NDMA). The FDA and the European Medicines Agency last year announced investigations of this NDMA contamination.
Dr. Mohyuddin and colleagues used IBM’s Explorys database, which includes data collected from EMRs from more than 40 U.S. health systems, to see if ranitidine use appeared connected to cancer diagnoses. Dr. Mohyuddin presented the findings in an abstract released as part of the annual Digestive Disease Week®, which was canceled because of COVID-19. The researchers identified records for 1.62 million users of ranitidine, 3.37 million users of famotidine, and 59.63 million people who did not use either H2 blocker.
The incidence of cancer was respectively 14.69%, 21.24%, and 5.38% for the ranitidine group, the famotidine group, and the group representing the general population without use of either H2 blocker. Among subjects without risk factors including smoking, obesity, alcohol use, family history, cirrhosis, and gastroesophageal reflux disease, ranitidine users did not have an increased risk of cancer, compared with famotidine users (odds ratio, 0.77; 95% confidence interval, 0.76-0.77; P < .001), Dr. Mohyuddin said in an email interview after her presentation.
“The results need to be interpreted with caution given that this is a retrospective study and it’s the first of its kind,” she said. “Further studies will be definitely needed on this to definitively answer the question, ‘does ranitidine have an increased risk of cancer?’ ”
People in the study who used H2 blockers tended to be older and were more likely to have other risk factors for cancers, according to the abstract:
- Of the ranitidine group, about 33.6% were older than 65, 74.4% were smokers, and 8.9% had a body mass index above 30 kg/m2.
- Of the famotidine group, about 38.3% were older than 65, 76.9% were smokers and 10.8% had a BMI above 30.
- Of the general population, about 23.9% were older than 65, 27.5% were smokers, and 1.69% were obese.
The Explorys database accounts for only 15%-19% of the entire U.S. population and that could be an explanation for why the percentage for obesity in the population seems spuriously low, Dr. Mohyuddin said in an email exchange.
Additionally, it pulls in patients through diagnosis codes, and if a different code for obesity was entered, those patients may not have been accounted for, she said.
Dhyanesh A. Patel, MD, assistant professor of medicine at Vanderbilt University, Nashville, Tenn., said it was a surprise to see the rate of cancer reported for famotidine users in the abstract presented at DDW.
“But these databases are so prone to multiple biases that it’s really hard to tease out. You’d really have to do prospective studies where you follow these patients and then control for variables to know the true risk,” Dr. Patel said in an interview.
In many cases, for example, patients may start on H2 blockers after reporting symptoms that sound like indigestion, Patel said.
“And then the next week, they actually get an upper endoscopy and they get diagnosed with gastric cancer,” Patel said. “In the database, it may seem to be that ranitidine was started and the patient was diagnosed with gastric cancer. So now the gastric cancer gets associated with ranitidine.”
Physicians have had many options to use instead of ranitidine since the FDA last year announced its concerns about the drug, Dr. Patel said.
“Patients can easily switch over to a similar histamine blocker or you can use one of the proton pump inhibitors that haven’t been found to have this impurity in them,” he said. “Both of those are good options for patients.”
Further research
Manufacturers have been withdrawing their ranitidine products from the market since the reports of contamination surfaced last year. Several drugmakers, including Pfizer and Perrigo, have reported facing lawsuits connected with claims of cancer or increased cancer risk from ranitidine. In February 2020, a federal judicial panel opted to use a procedure, known as multidistrict litigation (MDL), to streamline the handling of these many cases. They were put before the U.S. District Court for the Southern District of Florida, labeled as In Re: Zantac (Ranitidine) NDMA Litigation.
A spokesman for FDA declined MDedge’s request for comment on Dr. Mohyuddin’s DDW presentation. He said the agency tends not to offer its views on work done by scientists outside of the FDA.
Valisure, an online pharmacy that runs quality checks on the medicines it dispenses, in September 2019 petitioned the FDA for a withdrawal of ranitidine due to concerns about NDMA. In its petition, Valisure reported finding notable levels of NDMA in ranitidine tablets, but not detecting it in testing of famotidine and several similar drugs. In an emailed statement, David Light, founder and CEO of Valisure, said the structure of Dr. Mohyuddin’s research limited its ability to detect cancer correlations because of the large and generalized study population.
“When comparing millions of people on medications which are both over-the-counter and prescription, any epidemiological impact will very likely be eclipsed by the sheer variations of exposure and a wide variety of confounding factors,” Mr. Light wrote.
There are a “vast number of variables that aren’t controlled for in such a massive and broadly defined cohort,” he added.
More focused and controlled studies will be needed to best evaluate NDMA and ranitidine, according to Mr. Light. “We are also investigating this issue with researchers at Memorial Sloan Kettering Cancer Center and plan to publish results soon,” he said.
Dr. Mohyuddin and Dr. Patel did not disclose financial conflicts in connection with ranitidine.
SOURCE: Mohyuddin N et al. DDW 2020. Abstract Tu1360.
FROM DDW 2020
Parental injury, illness linked to increased pediatric GI visits, prescriptions
In a self-controlled case series using records from the Military Health System Data Repository, pediatric visits for disorders linked to gut-brain interactions were found to have increased 9% (incidence rate ratio, 1.09; 95% CI, 1.07-1.10) following a parent’s illness or injury, reported lead author Patrick Short, MD, of the Uniformed Services University of the Health Sciences, Bethesda, Md., said in an interview. The Military Health System Data Repository receives records from the Department of Defense’s global network of more than 260 medical facilities as well as outside health care organizations where military families are seen.
A secondary analysis done for this study found children of brain injured parents had 4% more postinjury visits for abdominal pain and 23% increased odds of antispasmodic prescription, compared with children whose parents had other physical injuries, Dr. Short said. He presented his research in an abstract released as part of the annual Digestive Disease Week, which was canceled because of COVID-19. The study focused on children aged 3-16 years with a parent who served in the military and was ill or injured between 2004 and 2014. Excluded from this research were records for children with diagnosed systemic or organic gastrointestinal disease, such as celiac disease.
The study used ICD-9 codes to identify outpatient visits for irritable bowel syndrome, abdominal pain, constipation, and fecal incontinence in the 2 years before and after parental injury or diagnosis of illness. Outpatient pharmacy records showed which of the children studied took laxatives and antispasmodics.
Parental injury or illness was defined by the placement of the children’s mothers and fathers on the injured, ill, or wounded file in the data repository. The data file generally covers people with conditions that severely limit their ability to do their usual jobs. These include traumatic brain injury, PTSD, amputation, shrapnel injury, and illnesses such as cancer.
There was a 7% increase in visits for constipation but fecal incontinence did not significantly change following parental illness or injury, Dr. Short said. But the odds of being prescribed an antispasmodic increased 23% following parents’ injuries and serious illnesses, while the odds for laxative prescription decreased by 5%.
The study highlights the potential physical impact of stress on children when families experience a crisis, Dr. Short said in an interview. Children may feel anxious about their parent’s health, while at the same time experiencing unavoidable disruption in family life because of an injury or illness.
“It impacts the day-to-day regimens and routines and decreases the family support,” Dr. Short said. “As humans we are limited in what we have to offer. When we are trying to take care of things on our own, it limits what we can give to people around us.”
The findings of this study should serve to remind physicians to alert parents that their children could experience worsening of GI conditions because of the stress of an ill or injured parent. They then can focus on securing help ahead of the time for the child, such as therapy, he said.
The next step in advancing on the research he prepared for DDW could be testing through prospective studies how well preventive measures such as family counseling work, Dr. Short said.
Dr. Short’s research adds to the growing body of evidence about the brain-gut connection, said Kara Gross Margolis, MD, a spokesperson for the American Gastroenterological Association. An associate professor of pediatrics at Columbia University Medical Center, New York, Dr. Margolis has published research on the brain-gut axis. Her lab focuses on the effects of neurotransmitters and inflammation on enteric nervous system development and function.
Physicians should take a broad view when treating children for functional GI illnesses. Behavioral therapy and antidepressants, for example, have been shown to help children with conditions such as irritable bowel syndrome and other functional gastrointestinal diseases, said Dr. Margolis.
“In a number of these cases, we not only have to treat the gut. We have to treat the brain as well,” Dr. Margolis said.
“When mental health issues are involved that impact the parents of these kids, You have to look at a family as an entire unit,” she added. “You not only treat the child for those symptoms, but you really have to look at how their parents can also be cared for so that their impact on their children will be positive as well.”
Research in the vein explored by Dr. Short will be important to remember as society works through the legacy of the COVID-19 pandemic, Dr. Margolis said. “We have huge numbers of families undergoing tremendous stress due to loss of jobs, health care, medical issues, and parental injury potentially from coronavirus.”
No outside funding was reported, and the study was covered through Uniformed Services University budget.
SOURCE: Short P et al. DDW 2020, Abstract 815.
In a self-controlled case series using records from the Military Health System Data Repository, pediatric visits for disorders linked to gut-brain interactions were found to have increased 9% (incidence rate ratio, 1.09; 95% CI, 1.07-1.10) following a parent’s illness or injury, reported lead author Patrick Short, MD, of the Uniformed Services University of the Health Sciences, Bethesda, Md., said in an interview. The Military Health System Data Repository receives records from the Department of Defense’s global network of more than 260 medical facilities as well as outside health care organizations where military families are seen.
A secondary analysis done for this study found children of brain injured parents had 4% more postinjury visits for abdominal pain and 23% increased odds of antispasmodic prescription, compared with children whose parents had other physical injuries, Dr. Short said. He presented his research in an abstract released as part of the annual Digestive Disease Week, which was canceled because of COVID-19. The study focused on children aged 3-16 years with a parent who served in the military and was ill or injured between 2004 and 2014. Excluded from this research were records for children with diagnosed systemic or organic gastrointestinal disease, such as celiac disease.
The study used ICD-9 codes to identify outpatient visits for irritable bowel syndrome, abdominal pain, constipation, and fecal incontinence in the 2 years before and after parental injury or diagnosis of illness. Outpatient pharmacy records showed which of the children studied took laxatives and antispasmodics.
Parental injury or illness was defined by the placement of the children’s mothers and fathers on the injured, ill, or wounded file in the data repository. The data file generally covers people with conditions that severely limit their ability to do their usual jobs. These include traumatic brain injury, PTSD, amputation, shrapnel injury, and illnesses such as cancer.
There was a 7% increase in visits for constipation but fecal incontinence did not significantly change following parental illness or injury, Dr. Short said. But the odds of being prescribed an antispasmodic increased 23% following parents’ injuries and serious illnesses, while the odds for laxative prescription decreased by 5%.
The study highlights the potential physical impact of stress on children when families experience a crisis, Dr. Short said in an interview. Children may feel anxious about their parent’s health, while at the same time experiencing unavoidable disruption in family life because of an injury or illness.
“It impacts the day-to-day regimens and routines and decreases the family support,” Dr. Short said. “As humans we are limited in what we have to offer. When we are trying to take care of things on our own, it limits what we can give to people around us.”
The findings of this study should serve to remind physicians to alert parents that their children could experience worsening of GI conditions because of the stress of an ill or injured parent. They then can focus on securing help ahead of the time for the child, such as therapy, he said.
The next step in advancing on the research he prepared for DDW could be testing through prospective studies how well preventive measures such as family counseling work, Dr. Short said.
Dr. Short’s research adds to the growing body of evidence about the brain-gut connection, said Kara Gross Margolis, MD, a spokesperson for the American Gastroenterological Association. An associate professor of pediatrics at Columbia University Medical Center, New York, Dr. Margolis has published research on the brain-gut axis. Her lab focuses on the effects of neurotransmitters and inflammation on enteric nervous system development and function.
Physicians should take a broad view when treating children for functional GI illnesses. Behavioral therapy and antidepressants, for example, have been shown to help children with conditions such as irritable bowel syndrome and other functional gastrointestinal diseases, said Dr. Margolis.
“In a number of these cases, we not only have to treat the gut. We have to treat the brain as well,” Dr. Margolis said.
“When mental health issues are involved that impact the parents of these kids, You have to look at a family as an entire unit,” she added. “You not only treat the child for those symptoms, but you really have to look at how their parents can also be cared for so that their impact on their children will be positive as well.”
Research in the vein explored by Dr. Short will be important to remember as society works through the legacy of the COVID-19 pandemic, Dr. Margolis said. “We have huge numbers of families undergoing tremendous stress due to loss of jobs, health care, medical issues, and parental injury potentially from coronavirus.”
No outside funding was reported, and the study was covered through Uniformed Services University budget.
SOURCE: Short P et al. DDW 2020, Abstract 815.
In a self-controlled case series using records from the Military Health System Data Repository, pediatric visits for disorders linked to gut-brain interactions were found to have increased 9% (incidence rate ratio, 1.09; 95% CI, 1.07-1.10) following a parent’s illness or injury, reported lead author Patrick Short, MD, of the Uniformed Services University of the Health Sciences, Bethesda, Md., said in an interview. The Military Health System Data Repository receives records from the Department of Defense’s global network of more than 260 medical facilities as well as outside health care organizations where military families are seen.
A secondary analysis done for this study found children of brain injured parents had 4% more postinjury visits for abdominal pain and 23% increased odds of antispasmodic prescription, compared with children whose parents had other physical injuries, Dr. Short said. He presented his research in an abstract released as part of the annual Digestive Disease Week, which was canceled because of COVID-19. The study focused on children aged 3-16 years with a parent who served in the military and was ill or injured between 2004 and 2014. Excluded from this research were records for children with diagnosed systemic or organic gastrointestinal disease, such as celiac disease.
The study used ICD-9 codes to identify outpatient visits for irritable bowel syndrome, abdominal pain, constipation, and fecal incontinence in the 2 years before and after parental injury or diagnosis of illness. Outpatient pharmacy records showed which of the children studied took laxatives and antispasmodics.
Parental injury or illness was defined by the placement of the children’s mothers and fathers on the injured, ill, or wounded file in the data repository. The data file generally covers people with conditions that severely limit their ability to do their usual jobs. These include traumatic brain injury, PTSD, amputation, shrapnel injury, and illnesses such as cancer.
There was a 7% increase in visits for constipation but fecal incontinence did not significantly change following parental illness or injury, Dr. Short said. But the odds of being prescribed an antispasmodic increased 23% following parents’ injuries and serious illnesses, while the odds for laxative prescription decreased by 5%.
The study highlights the potential physical impact of stress on children when families experience a crisis, Dr. Short said in an interview. Children may feel anxious about their parent’s health, while at the same time experiencing unavoidable disruption in family life because of an injury or illness.
“It impacts the day-to-day regimens and routines and decreases the family support,” Dr. Short said. “As humans we are limited in what we have to offer. When we are trying to take care of things on our own, it limits what we can give to people around us.”
The findings of this study should serve to remind physicians to alert parents that their children could experience worsening of GI conditions because of the stress of an ill or injured parent. They then can focus on securing help ahead of the time for the child, such as therapy, he said.
The next step in advancing on the research he prepared for DDW could be testing through prospective studies how well preventive measures such as family counseling work, Dr. Short said.
Dr. Short’s research adds to the growing body of evidence about the brain-gut connection, said Kara Gross Margolis, MD, a spokesperson for the American Gastroenterological Association. An associate professor of pediatrics at Columbia University Medical Center, New York, Dr. Margolis has published research on the brain-gut axis. Her lab focuses on the effects of neurotransmitters and inflammation on enteric nervous system development and function.
Physicians should take a broad view when treating children for functional GI illnesses. Behavioral therapy and antidepressants, for example, have been shown to help children with conditions such as irritable bowel syndrome and other functional gastrointestinal diseases, said Dr. Margolis.
“In a number of these cases, we not only have to treat the gut. We have to treat the brain as well,” Dr. Margolis said.
“When mental health issues are involved that impact the parents of these kids, You have to look at a family as an entire unit,” she added. “You not only treat the child for those symptoms, but you really have to look at how their parents can also be cared for so that their impact on their children will be positive as well.”
Research in the vein explored by Dr. Short will be important to remember as society works through the legacy of the COVID-19 pandemic, Dr. Margolis said. “We have huge numbers of families undergoing tremendous stress due to loss of jobs, health care, medical issues, and parental injury potentially from coronavirus.”
No outside funding was reported, and the study was covered through Uniformed Services University budget.
SOURCE: Short P et al. DDW 2020, Abstract 815.
FROM DDW 2020