User login
FDA okays Palforzia, first drug for peanut allergy in children
The Food and Drug Administration has approved the first drug to combat peanut allergy in children, (Palforzia, Aimmune Therapeutics), although those who take it must continue to avoid peanuts in their diets.
The peanut (Arachis hypogaea) allergen powder is also the first drug ever approved to treat a food allergy. It is not a cure, but it mitigates allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanuts, the FDA said in a news release.
Treatment with the oral powder, which is mixed into semisolid food – such as applesauce or yogurt – can be started in children aged 4 through 17 years who have a confirmed peanut allergy and then continued as a maintenance medication. Some 1 million American children have peanut allergy, and only a fifth will outgrow the allergy, the agency said.
“Because there is no cure, allergic individuals must strictly avoid exposure to prevent severe and potentially life-threatening reactions,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, in the statement.
An FDA advisory panel backed the medication in September 2019, but some committee members expressed concern about the large number of children in clinical trials who required epinephrine after receiving a dose of Palforzia.
The initial dose phase is given on a single day, while updosing consists of 11 increasing doses over several months. If the patient tolerates the first administration of an increased dose level, they may continue that dose daily at home. Daily maintenance begins after the completion of all updosing levels.
Palforzia will be available only through specially certified health care providers, health care settings, and pharmacies to patients enrolled in the REMS program, the agency said. Also, the initial dose escalation and first dose of each updosing level can be given only in a certified setting.
The agency said that patients or parents or caregivers must be counseled on the need for constant availability of injectable epinephrine, the need for continued dietary peanut avoidance, and on how to recognize the signs and symptoms of anaphylaxis.
‘Eagerly’ awaited
Palforzia’s effectiveness was based on a randomized, double-blind, placebo-controlled study involving about 500 peanut-allergic individuals that found that 67.2% of allergic patients tolerated an oral challenge with a single 600-mg dose of peanut protein with no more than mild allergic symptoms after 6 months of maintenance treatment, compared with 4% of placebo recipients, the FDA said.
In two double-blind, placebo-controlled studies looking at safety, the most commonly reported side effects among about 700 individuals involved in the research were abdominal pain, vomiting, nausea, tingling in the mouth, itching (including in the mouth and ears), cough, runny nose, throat irritation and tightness, hives, wheezing and shortness of breath, and anaphylaxis.
Palforzia should not be given to those with uncontrolled asthma and can’t be used for emergency treatment of allergic reactions, including anaphylaxis.
“The food allergy community has been eagerly awaiting an FDA-approved treatment that can help mitigate allergic reactions to peanut and, as allergists, we want nothing more than to have a treatment option to offer our patients that has demonstrated both the safety and efficacy to truly impact the lives of patients who live with peanut allergy,” said Christina Ciaccio, MD, chief of Allergy/Immunology and Pediatric Pulmonary Medicine at the University of Chicago Medical Center and Biological Sciences, in a company statement from Aimmune. “With today’s approval of Palforzia, we can – for the first time – offer children and teens with peanut allergy a proven medicine that employs an established therapeutic approach.”
This article first appeared on Medscape.com.
The Food and Drug Administration has approved the first drug to combat peanut allergy in children, (Palforzia, Aimmune Therapeutics), although those who take it must continue to avoid peanuts in their diets.
The peanut (Arachis hypogaea) allergen powder is also the first drug ever approved to treat a food allergy. It is not a cure, but it mitigates allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanuts, the FDA said in a news release.
Treatment with the oral powder, which is mixed into semisolid food – such as applesauce or yogurt – can be started in children aged 4 through 17 years who have a confirmed peanut allergy and then continued as a maintenance medication. Some 1 million American children have peanut allergy, and only a fifth will outgrow the allergy, the agency said.
“Because there is no cure, allergic individuals must strictly avoid exposure to prevent severe and potentially life-threatening reactions,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, in the statement.
An FDA advisory panel backed the medication in September 2019, but some committee members expressed concern about the large number of children in clinical trials who required epinephrine after receiving a dose of Palforzia.
The initial dose phase is given on a single day, while updosing consists of 11 increasing doses over several months. If the patient tolerates the first administration of an increased dose level, they may continue that dose daily at home. Daily maintenance begins after the completion of all updosing levels.
Palforzia will be available only through specially certified health care providers, health care settings, and pharmacies to patients enrolled in the REMS program, the agency said. Also, the initial dose escalation and first dose of each updosing level can be given only in a certified setting.
The agency said that patients or parents or caregivers must be counseled on the need for constant availability of injectable epinephrine, the need for continued dietary peanut avoidance, and on how to recognize the signs and symptoms of anaphylaxis.
‘Eagerly’ awaited
Palforzia’s effectiveness was based on a randomized, double-blind, placebo-controlled study involving about 500 peanut-allergic individuals that found that 67.2% of allergic patients tolerated an oral challenge with a single 600-mg dose of peanut protein with no more than mild allergic symptoms after 6 months of maintenance treatment, compared with 4% of placebo recipients, the FDA said.
In two double-blind, placebo-controlled studies looking at safety, the most commonly reported side effects among about 700 individuals involved in the research were abdominal pain, vomiting, nausea, tingling in the mouth, itching (including in the mouth and ears), cough, runny nose, throat irritation and tightness, hives, wheezing and shortness of breath, and anaphylaxis.
Palforzia should not be given to those with uncontrolled asthma and can’t be used for emergency treatment of allergic reactions, including anaphylaxis.
“The food allergy community has been eagerly awaiting an FDA-approved treatment that can help mitigate allergic reactions to peanut and, as allergists, we want nothing more than to have a treatment option to offer our patients that has demonstrated both the safety and efficacy to truly impact the lives of patients who live with peanut allergy,” said Christina Ciaccio, MD, chief of Allergy/Immunology and Pediatric Pulmonary Medicine at the University of Chicago Medical Center and Biological Sciences, in a company statement from Aimmune. “With today’s approval of Palforzia, we can – for the first time – offer children and teens with peanut allergy a proven medicine that employs an established therapeutic approach.”
This article first appeared on Medscape.com.
The Food and Drug Administration has approved the first drug to combat peanut allergy in children, (Palforzia, Aimmune Therapeutics), although those who take it must continue to avoid peanuts in their diets.
The peanut (Arachis hypogaea) allergen powder is also the first drug ever approved to treat a food allergy. It is not a cure, but it mitigates allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanuts, the FDA said in a news release.
Treatment with the oral powder, which is mixed into semisolid food – such as applesauce or yogurt – can be started in children aged 4 through 17 years who have a confirmed peanut allergy and then continued as a maintenance medication. Some 1 million American children have peanut allergy, and only a fifth will outgrow the allergy, the agency said.
“Because there is no cure, allergic individuals must strictly avoid exposure to prevent severe and potentially life-threatening reactions,” said Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research, in the statement.
An FDA advisory panel backed the medication in September 2019, but some committee members expressed concern about the large number of children in clinical trials who required epinephrine after receiving a dose of Palforzia.
The initial dose phase is given on a single day, while updosing consists of 11 increasing doses over several months. If the patient tolerates the first administration of an increased dose level, they may continue that dose daily at home. Daily maintenance begins after the completion of all updosing levels.
Palforzia will be available only through specially certified health care providers, health care settings, and pharmacies to patients enrolled in the REMS program, the agency said. Also, the initial dose escalation and first dose of each updosing level can be given only in a certified setting.
The agency said that patients or parents or caregivers must be counseled on the need for constant availability of injectable epinephrine, the need for continued dietary peanut avoidance, and on how to recognize the signs and symptoms of anaphylaxis.
‘Eagerly’ awaited
Palforzia’s effectiveness was based on a randomized, double-blind, placebo-controlled study involving about 500 peanut-allergic individuals that found that 67.2% of allergic patients tolerated an oral challenge with a single 600-mg dose of peanut protein with no more than mild allergic symptoms after 6 months of maintenance treatment, compared with 4% of placebo recipients, the FDA said.
In two double-blind, placebo-controlled studies looking at safety, the most commonly reported side effects among about 700 individuals involved in the research were abdominal pain, vomiting, nausea, tingling in the mouth, itching (including in the mouth and ears), cough, runny nose, throat irritation and tightness, hives, wheezing and shortness of breath, and anaphylaxis.
Palforzia should not be given to those with uncontrolled asthma and can’t be used for emergency treatment of allergic reactions, including anaphylaxis.
“The food allergy community has been eagerly awaiting an FDA-approved treatment that can help mitigate allergic reactions to peanut and, as allergists, we want nothing more than to have a treatment option to offer our patients that has demonstrated both the safety and efficacy to truly impact the lives of patients who live with peanut allergy,” said Christina Ciaccio, MD, chief of Allergy/Immunology and Pediatric Pulmonary Medicine at the University of Chicago Medical Center and Biological Sciences, in a company statement from Aimmune. “With today’s approval of Palforzia, we can – for the first time – offer children and teens with peanut allergy a proven medicine that employs an established therapeutic approach.”
This article first appeared on Medscape.com.
Surgeon General scolds docs for failing to help patients quit smoking
The U.S. Surgeon General is calling on all physicians to help patients stop smoking, noting that two-thirds of adult smokers say they want to quit, but only 40% report that their doctor has advised them to stop.
“I’ve got to own this as the nation’s doctor, and our health providers in this room and in this country need to own this stat,” said Surgeon General Jerome Adams, MD, at a press briefing releasing a new report on smoking cessation.
“Smoking is the No. 1 preventable cause of death, disease, and disability in the United States,” he said. “So why are 40% of our health providers out there not advising smokers to quit when they come in?”
In the first U.S. Surgeon General report on smoking cessation in 30 years, the 700-page report suggests smoking cessation-related quality measures that include physician reimbursement would increase treatment.
The evidence also suggests that using electronic health records to prompt clinicians to inquire about smoking would increase cessation treatment.
EHRs could be used to “empower and enable” physicians to advise people to quit, said Dr. Adams. Physicians also need “the education and the confidence to be able to have that conversation, because too many of them look at someone and say: ‘Nope, too hard, too much effort, no, that’s not what they’re here for today,’ ” he said.
However, “simply asking, advising, and referring can be enough to get someone on the pathway to quitting,” Dr. Adams said.
34 million still smoke
The new report is the first on the topic released since 1990, and the 34th on tobacco control since the first one was issued in 1964, said Dr. Adams. Since that first report, adult smoking has declined 70%, but some 34 million Americans (14%) still smoke, he said.
In addition, Dr. Adams said that many subpopulations have been left behind, noting: “Cigarette smoking remains highest among LGBTQ adults, people with disabilities or limitations, American Indians and Alaska Natives, and people with mental health conditions or substance use disorders.”
He also noted that 40% of cigarettes are consumed by those with a mental illness or a substance use disorder.
Quitting is beneficial at any age and can add as much as a decade to life expectancy, the report notes. Quitting also reduces the risk of 12 cancers, cuts the risk of chronic obstructive pulmonary disease, and reduces cardiovascular and stroke morbidity and mortality.
Pregnant women who quit also reduce their own morbidity and mortality risk and that of unborn children and infants, the report says.
“We know more about the science of quitting than ever before. We can, and must, do more to ensure that evidence-based cessation treatments are reaching the people that need them,” said Dr. Adams.
Less than one-third of those who have quit have used Food and Drug Administration–approved cessation medications or behavioral counseling, Dr. Adams said.
Barriers to care
Despite the existence of five nicotine replacement therapies and two nonnicotine oral medications, and more widespread availability of proven counseling methods – including web- or text-based programs – barriers to access remain.
These include a lack of insurance coverage for comprehensive, evidence-based smoking cessation treatment, which, when offered, increases availability and use.
“These are cost-effective interventions,” said Dr. Adams. “It’s penny wise and pound foolish to not give someone access to what we know works,” he said.
Because of the diversity of e-cigarette products and the variety of ways they are used, coupled with little research, it’s not currently possible to determine whether they are, or are not, useful smoking cessation tools, the report notes.
However, experts who compiled the report found some evidence to suggest that e-cigarettes containing nicotine may be “associated with increased smoking cessation compared with the use of e-cigarettes not containing nicotine.”
Asked whether the report’s conclusions might be interpreted as supportive of e-cigarettes, Dr. Adams said the report focused on smoking cessation, not initiation.
“I’m terribly concerned about the clear data that shows youth are initiating tobacco product use with e-cigarettes,” he said.
The Trump administration’s current proposal to partially restrict sales of some flavored e-cigarettes “reflects the science,” and “a balance between a desire to really make sure that people aren’t initiating with these products, but also a desire to again try to maintain a pathway for adults who want to use these products to quit to use them,” Dr. Adams said.
The focus, said Dr. Adams, should not be on e-cigarettes and whether they do, or do not, work.
“People want to quit,” he said. “We know what works. Not enough of them are getting it, and there are terrible disparities in who is and who is not getting access to effective and evidence-based treatment – that’s the story here.”
This article first appeared on Medscape.com.
The U.S. Surgeon General is calling on all physicians to help patients stop smoking, noting that two-thirds of adult smokers say they want to quit, but only 40% report that their doctor has advised them to stop.
“I’ve got to own this as the nation’s doctor, and our health providers in this room and in this country need to own this stat,” said Surgeon General Jerome Adams, MD, at a press briefing releasing a new report on smoking cessation.
“Smoking is the No. 1 preventable cause of death, disease, and disability in the United States,” he said. “So why are 40% of our health providers out there not advising smokers to quit when they come in?”
In the first U.S. Surgeon General report on smoking cessation in 30 years, the 700-page report suggests smoking cessation-related quality measures that include physician reimbursement would increase treatment.
The evidence also suggests that using electronic health records to prompt clinicians to inquire about smoking would increase cessation treatment.
EHRs could be used to “empower and enable” physicians to advise people to quit, said Dr. Adams. Physicians also need “the education and the confidence to be able to have that conversation, because too many of them look at someone and say: ‘Nope, too hard, too much effort, no, that’s not what they’re here for today,’ ” he said.
However, “simply asking, advising, and referring can be enough to get someone on the pathway to quitting,” Dr. Adams said.
34 million still smoke
The new report is the first on the topic released since 1990, and the 34th on tobacco control since the first one was issued in 1964, said Dr. Adams. Since that first report, adult smoking has declined 70%, but some 34 million Americans (14%) still smoke, he said.
In addition, Dr. Adams said that many subpopulations have been left behind, noting: “Cigarette smoking remains highest among LGBTQ adults, people with disabilities or limitations, American Indians and Alaska Natives, and people with mental health conditions or substance use disorders.”
He also noted that 40% of cigarettes are consumed by those with a mental illness or a substance use disorder.
Quitting is beneficial at any age and can add as much as a decade to life expectancy, the report notes. Quitting also reduces the risk of 12 cancers, cuts the risk of chronic obstructive pulmonary disease, and reduces cardiovascular and stroke morbidity and mortality.
Pregnant women who quit also reduce their own morbidity and mortality risk and that of unborn children and infants, the report says.
“We know more about the science of quitting than ever before. We can, and must, do more to ensure that evidence-based cessation treatments are reaching the people that need them,” said Dr. Adams.
Less than one-third of those who have quit have used Food and Drug Administration–approved cessation medications or behavioral counseling, Dr. Adams said.
Barriers to care
Despite the existence of five nicotine replacement therapies and two nonnicotine oral medications, and more widespread availability of proven counseling methods – including web- or text-based programs – barriers to access remain.
These include a lack of insurance coverage for comprehensive, evidence-based smoking cessation treatment, which, when offered, increases availability and use.
“These are cost-effective interventions,” said Dr. Adams. “It’s penny wise and pound foolish to not give someone access to what we know works,” he said.
Because of the diversity of e-cigarette products and the variety of ways they are used, coupled with little research, it’s not currently possible to determine whether they are, or are not, useful smoking cessation tools, the report notes.
However, experts who compiled the report found some evidence to suggest that e-cigarettes containing nicotine may be “associated with increased smoking cessation compared with the use of e-cigarettes not containing nicotine.”
Asked whether the report’s conclusions might be interpreted as supportive of e-cigarettes, Dr. Adams said the report focused on smoking cessation, not initiation.
“I’m terribly concerned about the clear data that shows youth are initiating tobacco product use with e-cigarettes,” he said.
The Trump administration’s current proposal to partially restrict sales of some flavored e-cigarettes “reflects the science,” and “a balance between a desire to really make sure that people aren’t initiating with these products, but also a desire to again try to maintain a pathway for adults who want to use these products to quit to use them,” Dr. Adams said.
The focus, said Dr. Adams, should not be on e-cigarettes and whether they do, or do not, work.
“People want to quit,” he said. “We know what works. Not enough of them are getting it, and there are terrible disparities in who is and who is not getting access to effective and evidence-based treatment – that’s the story here.”
This article first appeared on Medscape.com.
The U.S. Surgeon General is calling on all physicians to help patients stop smoking, noting that two-thirds of adult smokers say they want to quit, but only 40% report that their doctor has advised them to stop.
“I’ve got to own this as the nation’s doctor, and our health providers in this room and in this country need to own this stat,” said Surgeon General Jerome Adams, MD, at a press briefing releasing a new report on smoking cessation.
“Smoking is the No. 1 preventable cause of death, disease, and disability in the United States,” he said. “So why are 40% of our health providers out there not advising smokers to quit when they come in?”
In the first U.S. Surgeon General report on smoking cessation in 30 years, the 700-page report suggests smoking cessation-related quality measures that include physician reimbursement would increase treatment.
The evidence also suggests that using electronic health records to prompt clinicians to inquire about smoking would increase cessation treatment.
EHRs could be used to “empower and enable” physicians to advise people to quit, said Dr. Adams. Physicians also need “the education and the confidence to be able to have that conversation, because too many of them look at someone and say: ‘Nope, too hard, too much effort, no, that’s not what they’re here for today,’ ” he said.
However, “simply asking, advising, and referring can be enough to get someone on the pathway to quitting,” Dr. Adams said.
34 million still smoke
The new report is the first on the topic released since 1990, and the 34th on tobacco control since the first one was issued in 1964, said Dr. Adams. Since that first report, adult smoking has declined 70%, but some 34 million Americans (14%) still smoke, he said.
In addition, Dr. Adams said that many subpopulations have been left behind, noting: “Cigarette smoking remains highest among LGBTQ adults, people with disabilities or limitations, American Indians and Alaska Natives, and people with mental health conditions or substance use disorders.”
He also noted that 40% of cigarettes are consumed by those with a mental illness or a substance use disorder.
Quitting is beneficial at any age and can add as much as a decade to life expectancy, the report notes. Quitting also reduces the risk of 12 cancers, cuts the risk of chronic obstructive pulmonary disease, and reduces cardiovascular and stroke morbidity and mortality.
Pregnant women who quit also reduce their own morbidity and mortality risk and that of unborn children and infants, the report says.
“We know more about the science of quitting than ever before. We can, and must, do more to ensure that evidence-based cessation treatments are reaching the people that need them,” said Dr. Adams.
Less than one-third of those who have quit have used Food and Drug Administration–approved cessation medications or behavioral counseling, Dr. Adams said.
Barriers to care
Despite the existence of five nicotine replacement therapies and two nonnicotine oral medications, and more widespread availability of proven counseling methods – including web- or text-based programs – barriers to access remain.
These include a lack of insurance coverage for comprehensive, evidence-based smoking cessation treatment, which, when offered, increases availability and use.
“These are cost-effective interventions,” said Dr. Adams. “It’s penny wise and pound foolish to not give someone access to what we know works,” he said.
Because of the diversity of e-cigarette products and the variety of ways they are used, coupled with little research, it’s not currently possible to determine whether they are, or are not, useful smoking cessation tools, the report notes.
However, experts who compiled the report found some evidence to suggest that e-cigarettes containing nicotine may be “associated with increased smoking cessation compared with the use of e-cigarettes not containing nicotine.”
Asked whether the report’s conclusions might be interpreted as supportive of e-cigarettes, Dr. Adams said the report focused on smoking cessation, not initiation.
“I’m terribly concerned about the clear data that shows youth are initiating tobacco product use with e-cigarettes,” he said.
The Trump administration’s current proposal to partially restrict sales of some flavored e-cigarettes “reflects the science,” and “a balance between a desire to really make sure that people aren’t initiating with these products, but also a desire to again try to maintain a pathway for adults who want to use these products to quit to use them,” Dr. Adams said.
The focus, said Dr. Adams, should not be on e-cigarettes and whether they do, or do not, work.
“People want to quit,” he said. “We know what works. Not enough of them are getting it, and there are terrible disparities in who is and who is not getting access to effective and evidence-based treatment – that’s the story here.”
This article first appeared on Medscape.com.
Appeals court rules ACA’s individual mandate is unconstitutional
A federal appeals court ruled Dec. 18 that the individual mandate of the Affordable Care Act (ACA) is unconstitutional, but the panel sent the case back to a lower court to decide how much of the remainder of the law could topple along with it.
The three-judge panel of the New Orleans-based U.S. Fifth Circuit Court of Appeals said, “The individual mandate is unconstitutional because, under [a previous ruling, National Federation of Independent Business v Sebelius], it finds no constitutional footing in either the Interstate Commerce Clause or the Necessary and Proper Clause.”
The ruling upholds a December 2018 US District Court decision in which Judge Reed O’Connor found that the individual mandate that most Americans must have health insurance or pay a fine was unconstitutional and that without it the ACA itself was invalid.
In sending the case back to a Texas district court, however, the federal panel is asking for a central question to be resolved: Whether the individual mandate is “severable” from the rest of the law, while the rest of the law can be left intact.
If the district court eventually decides that the individual mandate cannot be severed from the rest of the ACA, the entire law will likely be ruled invalid, and some 24 million Americans could lose health coverage.
“Today’s ruling is the result of the Trump administration and congressional Republicans attempting to make dangerous health policy using the courts since they failed to succeed in Congress,” House Ways and Means Committee Chairman Richard E. Neal (D-Mass.) said in a statement. “This is a blow to our nation’s health care system and the millions of Americans who have gained coverage and protections under the Affordable Care Act. Democrats will continue to fight to protect Americans’ access to quality, affordable care.”
Some groups are applauding the decision, though. The Citizens’ Council for Health Freedom (CCHF), which filed an amicus brief with the Fifth Circuit arguing against the ACA, said it wants more.
“We are pleased with the Fifth Circuit Court of Appeals ruling, but it didn’t go far enough,” said Twila Brase, president and cofounder of CCHF, in a statement. “The individual mandate cannot be severed from the rest of the 2,700-page Affordable Care Act, thus the court should have ruled that the entire law is invalid, as the lower district court found.
“As the Court notes in the first paragraph of the ruling, we argued in our Amicus Brief, filed jointly with the Association of American Physicians and Surgeons, that the Act ‘has deprived patients nationwide of a competitive market for affordable high-deductible health insurance,’ leaving ‘patients with no alternative to ... skyrocketing premiums,’ “ Ms. Brase added. “Sending it back to the lower court, which already ruled the right way, continues to deprive citizens and patients of the affordable coverage that freedom from Obamacare would bring.”
Future uncertain
The ruling in Texas v Azar is not a surprise because, during oral arguments in July, as reported by Medscape Medical News, at least two of the three judges – Jennifer Walker Elrod, appointed by President George W. Bush in 2007, and Kurt Engelhardt, appointed by President Donald J. Trump in 2018 – appeared to be more receptive to the arguments of a group of 18 Republican states and two individuals seeking to invalidate the ACA.
Judge Carolyn Dineen King, appointed by President Jimmy Carter in 1979, did not comment during the hearing.
The Trump administration chose not to defend the ACA, but it does not seem entirely prepared for what might happen if the law is overturned. In a briefing before the Fifth Circuit hearing, the administration argued that, if ultimately the law is ruled unconstitutional, it should be struck down only in the states seeking to overturn the law.
“A lot of this has to get sorted out – it’s complicated,” said August E. Flentje, a U.S. Department of Justice lawyer, at the oral arguments in July.
For now, though, the ACA remains.
“In 2012, the Supreme Court upheld Obamacare, despite serious constitutional issues with the federal government forcing Americans to purchase a product from a private company. Until an ultimate decision is made by the Supreme Court or Congress decides otherwise, the Affordable Care Act will remain the law of the land,” Senate Finance Committee Chairman Chuck Grassley (R-Iowa), said in a statement.
And those who have led the court battle to keep the ACA intact plan to keep fighting. “For now, the President got the gift he wanted – uncertainty in the health care system and a pathway to repeal – so that the health care that seniors, workers, and families secured under the Affordable Care Act can be yanked from under them. This decision could take us to a dangerous and irresponsible place, not just for the 133 million Americans with pre-existing conditions, but for our seniors who use Medicare, our children under the age of 26, and the 20 million additional Americans covered directly through the ACA marketplace. California will move swiftly to challenge this decision because this could mean the difference between life and death for so many Americans and their families,” California Attorney General Xavier Becerra said in a statement.
Learn more about AGA’s position on patient protections and access to care at https://www.gastro.org/
A version of this story first appeared on Medscape.com.
A federal appeals court ruled Dec. 18 that the individual mandate of the Affordable Care Act (ACA) is unconstitutional, but the panel sent the case back to a lower court to decide how much of the remainder of the law could topple along with it.
The three-judge panel of the New Orleans-based U.S. Fifth Circuit Court of Appeals said, “The individual mandate is unconstitutional because, under [a previous ruling, National Federation of Independent Business v Sebelius], it finds no constitutional footing in either the Interstate Commerce Clause or the Necessary and Proper Clause.”
The ruling upholds a December 2018 US District Court decision in which Judge Reed O’Connor found that the individual mandate that most Americans must have health insurance or pay a fine was unconstitutional and that without it the ACA itself was invalid.
In sending the case back to a Texas district court, however, the federal panel is asking for a central question to be resolved: Whether the individual mandate is “severable” from the rest of the law, while the rest of the law can be left intact.
If the district court eventually decides that the individual mandate cannot be severed from the rest of the ACA, the entire law will likely be ruled invalid, and some 24 million Americans could lose health coverage.
“Today’s ruling is the result of the Trump administration and congressional Republicans attempting to make dangerous health policy using the courts since they failed to succeed in Congress,” House Ways and Means Committee Chairman Richard E. Neal (D-Mass.) said in a statement. “This is a blow to our nation’s health care system and the millions of Americans who have gained coverage and protections under the Affordable Care Act. Democrats will continue to fight to protect Americans’ access to quality, affordable care.”
Some groups are applauding the decision, though. The Citizens’ Council for Health Freedom (CCHF), which filed an amicus brief with the Fifth Circuit arguing against the ACA, said it wants more.
“We are pleased with the Fifth Circuit Court of Appeals ruling, but it didn’t go far enough,” said Twila Brase, president and cofounder of CCHF, in a statement. “The individual mandate cannot be severed from the rest of the 2,700-page Affordable Care Act, thus the court should have ruled that the entire law is invalid, as the lower district court found.
“As the Court notes in the first paragraph of the ruling, we argued in our Amicus Brief, filed jointly with the Association of American Physicians and Surgeons, that the Act ‘has deprived patients nationwide of a competitive market for affordable high-deductible health insurance,’ leaving ‘patients with no alternative to ... skyrocketing premiums,’ “ Ms. Brase added. “Sending it back to the lower court, which already ruled the right way, continues to deprive citizens and patients of the affordable coverage that freedom from Obamacare would bring.”
Future uncertain
The ruling in Texas v Azar is not a surprise because, during oral arguments in July, as reported by Medscape Medical News, at least two of the three judges – Jennifer Walker Elrod, appointed by President George W. Bush in 2007, and Kurt Engelhardt, appointed by President Donald J. Trump in 2018 – appeared to be more receptive to the arguments of a group of 18 Republican states and two individuals seeking to invalidate the ACA.
Judge Carolyn Dineen King, appointed by President Jimmy Carter in 1979, did not comment during the hearing.
The Trump administration chose not to defend the ACA, but it does not seem entirely prepared for what might happen if the law is overturned. In a briefing before the Fifth Circuit hearing, the administration argued that, if ultimately the law is ruled unconstitutional, it should be struck down only in the states seeking to overturn the law.
“A lot of this has to get sorted out – it’s complicated,” said August E. Flentje, a U.S. Department of Justice lawyer, at the oral arguments in July.
For now, though, the ACA remains.
“In 2012, the Supreme Court upheld Obamacare, despite serious constitutional issues with the federal government forcing Americans to purchase a product from a private company. Until an ultimate decision is made by the Supreme Court or Congress decides otherwise, the Affordable Care Act will remain the law of the land,” Senate Finance Committee Chairman Chuck Grassley (R-Iowa), said in a statement.
And those who have led the court battle to keep the ACA intact plan to keep fighting. “For now, the President got the gift he wanted – uncertainty in the health care system and a pathway to repeal – so that the health care that seniors, workers, and families secured under the Affordable Care Act can be yanked from under them. This decision could take us to a dangerous and irresponsible place, not just for the 133 million Americans with pre-existing conditions, but for our seniors who use Medicare, our children under the age of 26, and the 20 million additional Americans covered directly through the ACA marketplace. California will move swiftly to challenge this decision because this could mean the difference between life and death for so many Americans and their families,” California Attorney General Xavier Becerra said in a statement.
Learn more about AGA’s position on patient protections and access to care at https://www.gastro.org/
A version of this story first appeared on Medscape.com.
A federal appeals court ruled Dec. 18 that the individual mandate of the Affordable Care Act (ACA) is unconstitutional, but the panel sent the case back to a lower court to decide how much of the remainder of the law could topple along with it.
The three-judge panel of the New Orleans-based U.S. Fifth Circuit Court of Appeals said, “The individual mandate is unconstitutional because, under [a previous ruling, National Federation of Independent Business v Sebelius], it finds no constitutional footing in either the Interstate Commerce Clause or the Necessary and Proper Clause.”
The ruling upholds a December 2018 US District Court decision in which Judge Reed O’Connor found that the individual mandate that most Americans must have health insurance or pay a fine was unconstitutional and that without it the ACA itself was invalid.
In sending the case back to a Texas district court, however, the federal panel is asking for a central question to be resolved: Whether the individual mandate is “severable” from the rest of the law, while the rest of the law can be left intact.
If the district court eventually decides that the individual mandate cannot be severed from the rest of the ACA, the entire law will likely be ruled invalid, and some 24 million Americans could lose health coverage.
“Today’s ruling is the result of the Trump administration and congressional Republicans attempting to make dangerous health policy using the courts since they failed to succeed in Congress,” House Ways and Means Committee Chairman Richard E. Neal (D-Mass.) said in a statement. “This is a blow to our nation’s health care system and the millions of Americans who have gained coverage and protections under the Affordable Care Act. Democrats will continue to fight to protect Americans’ access to quality, affordable care.”
Some groups are applauding the decision, though. The Citizens’ Council for Health Freedom (CCHF), which filed an amicus brief with the Fifth Circuit arguing against the ACA, said it wants more.
“We are pleased with the Fifth Circuit Court of Appeals ruling, but it didn’t go far enough,” said Twila Brase, president and cofounder of CCHF, in a statement. “The individual mandate cannot be severed from the rest of the 2,700-page Affordable Care Act, thus the court should have ruled that the entire law is invalid, as the lower district court found.
“As the Court notes in the first paragraph of the ruling, we argued in our Amicus Brief, filed jointly with the Association of American Physicians and Surgeons, that the Act ‘has deprived patients nationwide of a competitive market for affordable high-deductible health insurance,’ leaving ‘patients with no alternative to ... skyrocketing premiums,’ “ Ms. Brase added. “Sending it back to the lower court, which already ruled the right way, continues to deprive citizens and patients of the affordable coverage that freedom from Obamacare would bring.”
Future uncertain
The ruling in Texas v Azar is not a surprise because, during oral arguments in July, as reported by Medscape Medical News, at least two of the three judges – Jennifer Walker Elrod, appointed by President George W. Bush in 2007, and Kurt Engelhardt, appointed by President Donald J. Trump in 2018 – appeared to be more receptive to the arguments of a group of 18 Republican states and two individuals seeking to invalidate the ACA.
Judge Carolyn Dineen King, appointed by President Jimmy Carter in 1979, did not comment during the hearing.
The Trump administration chose not to defend the ACA, but it does not seem entirely prepared for what might happen if the law is overturned. In a briefing before the Fifth Circuit hearing, the administration argued that, if ultimately the law is ruled unconstitutional, it should be struck down only in the states seeking to overturn the law.
“A lot of this has to get sorted out – it’s complicated,” said August E. Flentje, a U.S. Department of Justice lawyer, at the oral arguments in July.
For now, though, the ACA remains.
“In 2012, the Supreme Court upheld Obamacare, despite serious constitutional issues with the federal government forcing Americans to purchase a product from a private company. Until an ultimate decision is made by the Supreme Court or Congress decides otherwise, the Affordable Care Act will remain the law of the land,” Senate Finance Committee Chairman Chuck Grassley (R-Iowa), said in a statement.
And those who have led the court battle to keep the ACA intact plan to keep fighting. “For now, the President got the gift he wanted – uncertainty in the health care system and a pathway to repeal – so that the health care that seniors, workers, and families secured under the Affordable Care Act can be yanked from under them. This decision could take us to a dangerous and irresponsible place, not just for the 133 million Americans with pre-existing conditions, but for our seniors who use Medicare, our children under the age of 26, and the 20 million additional Americans covered directly through the ACA marketplace. California will move swiftly to challenge this decision because this could mean the difference between life and death for so many Americans and their families,” California Attorney General Xavier Becerra said in a statement.
Learn more about AGA’s position on patient protections and access to care at https://www.gastro.org/
A version of this story first appeared on Medscape.com.
Appeals court rules ACA’s individual mandate is unconstitutional
A federal appeals court ruled Dec. 18 that the individual mandate of the Affordable Care Act (ACA) is unconstitutional, but the panel sent the case back to a lower court to decide how much of the remainder of the law could topple along with it.
The three-judge panel of the New Orleans-based U.S. Fifth Circuit Court of Appeals said, “The individual mandate is unconstitutional because, under [a previous ruling, National Federation of Independent Business v Sebelius], it finds no constitutional footing in either the Interstate Commerce Clause or the Necessary and Proper Clause.”
The ruling upholds a December 2018 US District Court decision in which Judge Reed O’Connor found that the individual mandate that most Americans must have health insurance or pay a fine was unconstitutional and that without it the ACA itself was invalid.
In sending the case back to a Texas district court, however, the federal panel is asking for a central question to be resolved: Whether the individual mandate is “severable” from the rest of the law, while the rest of the law can be left intact.
If the district court eventually decides that the individual mandate cannot be severed from the rest of the ACA, the entire law will likely be ruled invalid, and some 24 million Americans could lose health coverage.
“Today’s ruling is the result of the Trump administration and congressional Republicans attempting to make dangerous health policy using the courts since they failed to succeed in Congress,” House Ways and Means Committee Chairman Richard E. Neal (D-Mass.) said in a statement. “This is a blow to our nation’s health care system and the millions of Americans who have gained coverage and protections under the Affordable Care Act. Democrats will continue to fight to protect Americans’ access to quality, affordable care.”
Some groups are applauding the decision, though. The Citizens’ Council for Health Freedom (CCHF), which filed an amicus brief with the Fifth Circuit arguing against the ACA, said it wants more.
“We are pleased with the Fifth Circuit Court of Appeals ruling, but it didn’t go far enough,” said Twila Brase, president and cofounder of CCHF, in a statement. “The individual mandate cannot be severed from the rest of the 2,700-page Affordable Care Act, thus the court should have ruled that the entire law is invalid, as the lower district court found.
“As the Court notes in the first paragraph of the ruling, we argued in our Amicus Brief, filed jointly with the Association of American Physicians and Surgeons, that the Act ‘has deprived patients nationwide of a competitive market for affordable high-deductible health insurance,’ leaving ‘patients with no alternative to ... skyrocketing premiums,’ “ Ms. Brase added. “Sending it back to the lower court, which already ruled the right way, continues to deprive citizens and patients of the affordable coverage that freedom from Obamacare would bring.”
Future uncertain
The ruling in Texas v Azar is not a surprise because, during oral arguments in July, as reported by Medscape Medical News, at least two of the three judges – Jennifer Walker Elrod, appointed by President George W. Bush in 2007, and Kurt Engelhardt, appointed by President Donald J. Trump in 2018 – appeared to be more receptive to the arguments of a group of 18 Republican states and two individuals seeking to invalidate the ACA.
Judge Carolyn Dineen King, appointed by President Jimmy Carter in 1979, did not comment during the hearing.
The Trump administration chose not to defend the ACA, but it does not seem entirely prepared for what might happen if the law is overturned. In a briefing before the Fifth Circuit hearing, the administration argued that, if ultimately the law is ruled unconstitutional, it should be struck down only in the states seeking to overturn the law.
“A lot of this has to get sorted out – it’s complicated,” said August E. Flentje, a U.S. Department of Justice lawyer, at the oral arguments in July.
For now, though, the ACA remains.
“In 2012, the Supreme Court upheld Obamacare, despite serious constitutional issues with the federal government forcing Americans to purchase a product from a private company. Until an ultimate decision is made by the Supreme Court or Congress decides otherwise, the Affordable Care Act will remain the law of the land,” Senate Finance Committee Chairman Chuck Grassley (R-Iowa), said in a statement.
And those who have led the court battle to keep the ACA intact plan to keep fighting. “For now, the President got the gift he wanted – uncertainty in the health care system and a pathway to repeal – so that the health care that seniors, workers, and families secured under the Affordable Care Act can be yanked from under them. This decision could take us to a dangerous and irresponsible place, not just for the 133 million Americans with pre-existing conditions, but for our seniors who use Medicare, our children under the age of 26, and the 20 million additional Americans covered directly through the ACA marketplace. California will move swiftly to challenge this decision because this could mean the difference between life and death for so many Americans and their families,” California Attorney General Xavier Becerra said in a statement.
A version of this story first appeared on Medscape.com.
A federal appeals court ruled Dec. 18 that the individual mandate of the Affordable Care Act (ACA) is unconstitutional, but the panel sent the case back to a lower court to decide how much of the remainder of the law could topple along with it.
The three-judge panel of the New Orleans-based U.S. Fifth Circuit Court of Appeals said, “The individual mandate is unconstitutional because, under [a previous ruling, National Federation of Independent Business v Sebelius], it finds no constitutional footing in either the Interstate Commerce Clause or the Necessary and Proper Clause.”
The ruling upholds a December 2018 US District Court decision in which Judge Reed O’Connor found that the individual mandate that most Americans must have health insurance or pay a fine was unconstitutional and that without it the ACA itself was invalid.
In sending the case back to a Texas district court, however, the federal panel is asking for a central question to be resolved: Whether the individual mandate is “severable” from the rest of the law, while the rest of the law can be left intact.
If the district court eventually decides that the individual mandate cannot be severed from the rest of the ACA, the entire law will likely be ruled invalid, and some 24 million Americans could lose health coverage.
“Today’s ruling is the result of the Trump administration and congressional Republicans attempting to make dangerous health policy using the courts since they failed to succeed in Congress,” House Ways and Means Committee Chairman Richard E. Neal (D-Mass.) said in a statement. “This is a blow to our nation’s health care system and the millions of Americans who have gained coverage and protections under the Affordable Care Act. Democrats will continue to fight to protect Americans’ access to quality, affordable care.”
Some groups are applauding the decision, though. The Citizens’ Council for Health Freedom (CCHF), which filed an amicus brief with the Fifth Circuit arguing against the ACA, said it wants more.
“We are pleased with the Fifth Circuit Court of Appeals ruling, but it didn’t go far enough,” said Twila Brase, president and cofounder of CCHF, in a statement. “The individual mandate cannot be severed from the rest of the 2,700-page Affordable Care Act, thus the court should have ruled that the entire law is invalid, as the lower district court found.
“As the Court notes in the first paragraph of the ruling, we argued in our Amicus Brief, filed jointly with the Association of American Physicians and Surgeons, that the Act ‘has deprived patients nationwide of a competitive market for affordable high-deductible health insurance,’ leaving ‘patients with no alternative to ... skyrocketing premiums,’ “ Ms. Brase added. “Sending it back to the lower court, which already ruled the right way, continues to deprive citizens and patients of the affordable coverage that freedom from Obamacare would bring.”
Future uncertain
The ruling in Texas v Azar is not a surprise because, during oral arguments in July, as reported by Medscape Medical News, at least two of the three judges – Jennifer Walker Elrod, appointed by President George W. Bush in 2007, and Kurt Engelhardt, appointed by President Donald J. Trump in 2018 – appeared to be more receptive to the arguments of a group of 18 Republican states and two individuals seeking to invalidate the ACA.
Judge Carolyn Dineen King, appointed by President Jimmy Carter in 1979, did not comment during the hearing.
The Trump administration chose not to defend the ACA, but it does not seem entirely prepared for what might happen if the law is overturned. In a briefing before the Fifth Circuit hearing, the administration argued that, if ultimately the law is ruled unconstitutional, it should be struck down only in the states seeking to overturn the law.
“A lot of this has to get sorted out – it’s complicated,” said August E. Flentje, a U.S. Department of Justice lawyer, at the oral arguments in July.
For now, though, the ACA remains.
“In 2012, the Supreme Court upheld Obamacare, despite serious constitutional issues with the federal government forcing Americans to purchase a product from a private company. Until an ultimate decision is made by the Supreme Court or Congress decides otherwise, the Affordable Care Act will remain the law of the land,” Senate Finance Committee Chairman Chuck Grassley (R-Iowa), said in a statement.
And those who have led the court battle to keep the ACA intact plan to keep fighting. “For now, the President got the gift he wanted – uncertainty in the health care system and a pathway to repeal – so that the health care that seniors, workers, and families secured under the Affordable Care Act can be yanked from under them. This decision could take us to a dangerous and irresponsible place, not just for the 133 million Americans with pre-existing conditions, but for our seniors who use Medicare, our children under the age of 26, and the 20 million additional Americans covered directly through the ACA marketplace. California will move swiftly to challenge this decision because this could mean the difference between life and death for so many Americans and their families,” California Attorney General Xavier Becerra said in a statement.
A version of this story first appeared on Medscape.com.
A federal appeals court ruled Dec. 18 that the individual mandate of the Affordable Care Act (ACA) is unconstitutional, but the panel sent the case back to a lower court to decide how much of the remainder of the law could topple along with it.
The three-judge panel of the New Orleans-based U.S. Fifth Circuit Court of Appeals said, “The individual mandate is unconstitutional because, under [a previous ruling, National Federation of Independent Business v Sebelius], it finds no constitutional footing in either the Interstate Commerce Clause or the Necessary and Proper Clause.”
The ruling upholds a December 2018 US District Court decision in which Judge Reed O’Connor found that the individual mandate that most Americans must have health insurance or pay a fine was unconstitutional and that without it the ACA itself was invalid.
In sending the case back to a Texas district court, however, the federal panel is asking for a central question to be resolved: Whether the individual mandate is “severable” from the rest of the law, while the rest of the law can be left intact.
If the district court eventually decides that the individual mandate cannot be severed from the rest of the ACA, the entire law will likely be ruled invalid, and some 24 million Americans could lose health coverage.
“Today’s ruling is the result of the Trump administration and congressional Republicans attempting to make dangerous health policy using the courts since they failed to succeed in Congress,” House Ways and Means Committee Chairman Richard E. Neal (D-Mass.) said in a statement. “This is a blow to our nation’s health care system and the millions of Americans who have gained coverage and protections under the Affordable Care Act. Democrats will continue to fight to protect Americans’ access to quality, affordable care.”
Some groups are applauding the decision, though. The Citizens’ Council for Health Freedom (CCHF), which filed an amicus brief with the Fifth Circuit arguing against the ACA, said it wants more.
“We are pleased with the Fifth Circuit Court of Appeals ruling, but it didn’t go far enough,” said Twila Brase, president and cofounder of CCHF, in a statement. “The individual mandate cannot be severed from the rest of the 2,700-page Affordable Care Act, thus the court should have ruled that the entire law is invalid, as the lower district court found.
“As the Court notes in the first paragraph of the ruling, we argued in our Amicus Brief, filed jointly with the Association of American Physicians and Surgeons, that the Act ‘has deprived patients nationwide of a competitive market for affordable high-deductible health insurance,’ leaving ‘patients with no alternative to ... skyrocketing premiums,’ “ Ms. Brase added. “Sending it back to the lower court, which already ruled the right way, continues to deprive citizens and patients of the affordable coverage that freedom from Obamacare would bring.”
Future uncertain
The ruling in Texas v Azar is not a surprise because, during oral arguments in July, as reported by Medscape Medical News, at least two of the three judges – Jennifer Walker Elrod, appointed by President George W. Bush in 2007, and Kurt Engelhardt, appointed by President Donald J. Trump in 2018 – appeared to be more receptive to the arguments of a group of 18 Republican states and two individuals seeking to invalidate the ACA.
Judge Carolyn Dineen King, appointed by President Jimmy Carter in 1979, did not comment during the hearing.
The Trump administration chose not to defend the ACA, but it does not seem entirely prepared for what might happen if the law is overturned. In a briefing before the Fifth Circuit hearing, the administration argued that, if ultimately the law is ruled unconstitutional, it should be struck down only in the states seeking to overturn the law.
“A lot of this has to get sorted out – it’s complicated,” said August E. Flentje, a U.S. Department of Justice lawyer, at the oral arguments in July.
For now, though, the ACA remains.
“In 2012, the Supreme Court upheld Obamacare, despite serious constitutional issues with the federal government forcing Americans to purchase a product from a private company. Until an ultimate decision is made by the Supreme Court or Congress decides otherwise, the Affordable Care Act will remain the law of the land,” Senate Finance Committee Chairman Chuck Grassley (R-Iowa), said in a statement.
And those who have led the court battle to keep the ACA intact plan to keep fighting. “For now, the President got the gift he wanted – uncertainty in the health care system and a pathway to repeal – so that the health care that seniors, workers, and families secured under the Affordable Care Act can be yanked from under them. This decision could take us to a dangerous and irresponsible place, not just for the 133 million Americans with pre-existing conditions, but for our seniors who use Medicare, our children under the age of 26, and the 20 million additional Americans covered directly through the ACA marketplace. California will move swiftly to challenge this decision because this could mean the difference between life and death for so many Americans and their families,” California Attorney General Xavier Becerra said in a statement.
A version of this story first appeared on Medscape.com.
Clinicians ask FDA for continued ‘discretion’ to do fecal transplants
Attendees at a public meeting on Nov. 4 gave the US Food and Drug Administration conflicting views on whether the agency should continue to allow a relatively loose regulatory environment for fecal microbiota transplants (FMT) – debating the limits of “enforcement discretion” the FDA now has in place.
The question is especially relevant as use of the procedure is growing, while safety data are not being rigorously collected in all cases. The death of an immunocompromised FMT patient earlier in 2018 from an invasive bacterial infection caused by drug-resistant Escherichia coli, as reported by Medscape Medical News, is seen by some as an example of the consequences of a loose policy.
Still, the American Gastroenterological Association (AGA) presented new, unpublished follow-up data at the meeting that showed that the majority of FMT patients in a national registry had no adverse events.
Some companies developing FMT-based products argued at the meeting that the agency should impose stricter requirements, while stool banks and clinicians offering the therapy outside of clinical trials said that the current policy – in place since 2013 – in which the FDA has exercised “enforcement discretion,” should be allowed to continue.
“Enforcement discretion has been successful in enabling and overcoming key barriers to access to treatment,” said Majdi Osman, MD, clinical program director at OpenBiome, a nonprofit stool bank based in Cambridge, Mass. Dr. Osman said that 98% of the U.S. population now lives within a 2-hour drive of an FMT provider.
Amanda Kabage, a researcher and donor program coordinator for the Microbiota Therapeutics program at the University of Minnesota in Minneapolis, and herself a former recipient of FMT, said she was in favor of continuing the FDA policy.
“If enforcement discretion were to go away, patients far sicker than I was will not have access. They’ll get sicker and they will die,” Ms. Kabage said.
But, she added, the FDA had missed an opportunity by not insisting on collecting outcomes and safety data. Minnesota has established a patient registry to do just that, and physicians cannot administer FMT unless they agree to participate, she said. In response, FDA panelists noted that the agency cannot mandate data collection under an enforcement policy.
Lee Jones, founder and chief executive officer of Rebiotix/Ferring, a biotech company focused on the development of microbiome-based therapeutics, argued for tighter restrictions, however, claiming that increased access – and the FDA policy – had led to a fourfold decrease in enrollment since the company began study of its lead FMT product, RBX2660, in 2013.
“We’re dealing with an orphan indication and the patients were hard to come by to begin with,” she said at the meeting. “Enforcement discretion has slowed our clinical development and delayed patient access to FDA-approved therapies by over 2 years.”
An investigator at the University of Texas Health Science Center at Houston, Herbert DuPont, MD, who has administered FMT and is conducting a trial for Rebiotix, said his center wanted the FDA policy to continue “allowing multiple groups to perform FMT for recurrent [Clostridium difficile], because of the incredible public health need.”
But, he added, “We’re very concerned about industry and ability to do clinical trials.”
Those trials are important, Dr. DuPont said. “I think we have to address very actively how industry can move these products through,” he said, “because all of us want to remove the F from FMT,” by isolating the necessary elements of the process while not having the risk sometimes associated with human stool.
Policy slow to evolve
“I’m frustrated that it’s taken over 6 years and three draft guidances to get us this far,” Christian John Lillis, executive director of the Peggy Lillis Foundation – a group dedicated to creating awareness about the dangers of C. difficile – said at the meeting.
Mr. Lillis said that probably several thousand deaths had been prevented through increased FMT access, but that it was time to create a concrete policy that advanced the therapy.
The FDA guidance issued in 2013 allowed physicians to provide FMT for recurrent or refractory C. difficile infection without filing an investigational new drug (IND) application.
Clinicians must obtain informed consent that includes a discussion of the risks, and a statement that FMT is investigational. In March 2016, the agency issued revised draft guidance that it was aiming to require stool banks to apply for INDs, as reported by Medscape Medical News.
OpenBiome has flourished under the current policy. It has provided more than 50,000 treatments to 1,200 hospitals and clinics, and has provided FMT for 49 clinical trials and for 16 single patients who received INDs, Dr. Osman said.
But requiring INDs for all centers is a bad idea, he said. “IND requirements are insurmountable for most health centers,” Dr. Osman said, noting that most of the FMT material OpenBiome produces is sent to community-based physicians.
“These requirements would likely mean restrictions in access for stool bank–provided FMT and potentially pushing patients to physician-directed FMT or discouraging physicians from using FMT at all,” he said.
Stacy Kahn, MD, FMT director at Boston Children’s Hospital in Massachusetts, said that having ready access from a stool bank was crucial.
“Universal donor FMT is much easier, much faster and much more cost effective than what we can do as clinicians,” she said.
New safety and efficacy data
One unpublished study showed that 75% of patients treated since 2011 had a sustained cure, noted Colleen Kelly, MD, a Brown University professor of medicine and principal investigator for the National Institutes of Health–funded national FMT registry (although the data in this study were not from the FMT registry).
The study, which was a collaboration between the Alpert Medical School of Brown University, Brigham and Women’s Hospital, and Indiana University School of Medicine, attempted follow-up on 533 patients; 208 were successfully contacted, and an additional 55 had died, none due to FMT.
Dr. Kelly also presented data from the FMT National Registry showing that at 1 month posttransplant, two (1%) of 253 patients had an infection possibly related to FMT; one with Bacteroides fragilis and one with enteropathogenic E. coli. Seven hospitalizations were deemed related or possibly related to FMT, including two recurrences of C. difficile.
At 6 months posttransplant, 8 (5%) of 152 patients had a serious infection, and 23 patients reported a diagnosis of a new condition, primarily diarrhea-predominant irritable bowel syndrome, which is common post FMT, said Dr. Kelly, who presented the data on behalf of AGA, which administers the registry.
The AGA supports a continuation of the enforcement discretion as a means to maintain patient access where the evidence supports the use of FMT, but the group does not back use of FMT outside medical supervision, Dr. Kelly said.
This article originally appeared on Medscape. For more news, follow Medscape on Facebook, Twitter, Instagram, and YouTube.
Attendees at a public meeting on Nov. 4 gave the US Food and Drug Administration conflicting views on whether the agency should continue to allow a relatively loose regulatory environment for fecal microbiota transplants (FMT) – debating the limits of “enforcement discretion” the FDA now has in place.
The question is especially relevant as use of the procedure is growing, while safety data are not being rigorously collected in all cases. The death of an immunocompromised FMT patient earlier in 2018 from an invasive bacterial infection caused by drug-resistant Escherichia coli, as reported by Medscape Medical News, is seen by some as an example of the consequences of a loose policy.
Still, the American Gastroenterological Association (AGA) presented new, unpublished follow-up data at the meeting that showed that the majority of FMT patients in a national registry had no adverse events.
Some companies developing FMT-based products argued at the meeting that the agency should impose stricter requirements, while stool banks and clinicians offering the therapy outside of clinical trials said that the current policy – in place since 2013 – in which the FDA has exercised “enforcement discretion,” should be allowed to continue.
“Enforcement discretion has been successful in enabling and overcoming key barriers to access to treatment,” said Majdi Osman, MD, clinical program director at OpenBiome, a nonprofit stool bank based in Cambridge, Mass. Dr. Osman said that 98% of the U.S. population now lives within a 2-hour drive of an FMT provider.
Amanda Kabage, a researcher and donor program coordinator for the Microbiota Therapeutics program at the University of Minnesota in Minneapolis, and herself a former recipient of FMT, said she was in favor of continuing the FDA policy.
“If enforcement discretion were to go away, patients far sicker than I was will not have access. They’ll get sicker and they will die,” Ms. Kabage said.
But, she added, the FDA had missed an opportunity by not insisting on collecting outcomes and safety data. Minnesota has established a patient registry to do just that, and physicians cannot administer FMT unless they agree to participate, she said. In response, FDA panelists noted that the agency cannot mandate data collection under an enforcement policy.
Lee Jones, founder and chief executive officer of Rebiotix/Ferring, a biotech company focused on the development of microbiome-based therapeutics, argued for tighter restrictions, however, claiming that increased access – and the FDA policy – had led to a fourfold decrease in enrollment since the company began study of its lead FMT product, RBX2660, in 2013.
“We’re dealing with an orphan indication and the patients were hard to come by to begin with,” she said at the meeting. “Enforcement discretion has slowed our clinical development and delayed patient access to FDA-approved therapies by over 2 years.”
An investigator at the University of Texas Health Science Center at Houston, Herbert DuPont, MD, who has administered FMT and is conducting a trial for Rebiotix, said his center wanted the FDA policy to continue “allowing multiple groups to perform FMT for recurrent [Clostridium difficile], because of the incredible public health need.”
But, he added, “We’re very concerned about industry and ability to do clinical trials.”
Those trials are important, Dr. DuPont said. “I think we have to address very actively how industry can move these products through,” he said, “because all of us want to remove the F from FMT,” by isolating the necessary elements of the process while not having the risk sometimes associated with human stool.
Policy slow to evolve
“I’m frustrated that it’s taken over 6 years and three draft guidances to get us this far,” Christian John Lillis, executive director of the Peggy Lillis Foundation – a group dedicated to creating awareness about the dangers of C. difficile – said at the meeting.
Mr. Lillis said that probably several thousand deaths had been prevented through increased FMT access, but that it was time to create a concrete policy that advanced the therapy.
The FDA guidance issued in 2013 allowed physicians to provide FMT for recurrent or refractory C. difficile infection without filing an investigational new drug (IND) application.
Clinicians must obtain informed consent that includes a discussion of the risks, and a statement that FMT is investigational. In March 2016, the agency issued revised draft guidance that it was aiming to require stool banks to apply for INDs, as reported by Medscape Medical News.
OpenBiome has flourished under the current policy. It has provided more than 50,000 treatments to 1,200 hospitals and clinics, and has provided FMT for 49 clinical trials and for 16 single patients who received INDs, Dr. Osman said.
But requiring INDs for all centers is a bad idea, he said. “IND requirements are insurmountable for most health centers,” Dr. Osman said, noting that most of the FMT material OpenBiome produces is sent to community-based physicians.
“These requirements would likely mean restrictions in access for stool bank–provided FMT and potentially pushing patients to physician-directed FMT or discouraging physicians from using FMT at all,” he said.
Stacy Kahn, MD, FMT director at Boston Children’s Hospital in Massachusetts, said that having ready access from a stool bank was crucial.
“Universal donor FMT is much easier, much faster and much more cost effective than what we can do as clinicians,” she said.
New safety and efficacy data
One unpublished study showed that 75% of patients treated since 2011 had a sustained cure, noted Colleen Kelly, MD, a Brown University professor of medicine and principal investigator for the National Institutes of Health–funded national FMT registry (although the data in this study were not from the FMT registry).
The study, which was a collaboration between the Alpert Medical School of Brown University, Brigham and Women’s Hospital, and Indiana University School of Medicine, attempted follow-up on 533 patients; 208 were successfully contacted, and an additional 55 had died, none due to FMT.
Dr. Kelly also presented data from the FMT National Registry showing that at 1 month posttransplant, two (1%) of 253 patients had an infection possibly related to FMT; one with Bacteroides fragilis and one with enteropathogenic E. coli. Seven hospitalizations were deemed related or possibly related to FMT, including two recurrences of C. difficile.
At 6 months posttransplant, 8 (5%) of 152 patients had a serious infection, and 23 patients reported a diagnosis of a new condition, primarily diarrhea-predominant irritable bowel syndrome, which is common post FMT, said Dr. Kelly, who presented the data on behalf of AGA, which administers the registry.
The AGA supports a continuation of the enforcement discretion as a means to maintain patient access where the evidence supports the use of FMT, but the group does not back use of FMT outside medical supervision, Dr. Kelly said.
This article originally appeared on Medscape. For more news, follow Medscape on Facebook, Twitter, Instagram, and YouTube.
Attendees at a public meeting on Nov. 4 gave the US Food and Drug Administration conflicting views on whether the agency should continue to allow a relatively loose regulatory environment for fecal microbiota transplants (FMT) – debating the limits of “enforcement discretion” the FDA now has in place.
The question is especially relevant as use of the procedure is growing, while safety data are not being rigorously collected in all cases. The death of an immunocompromised FMT patient earlier in 2018 from an invasive bacterial infection caused by drug-resistant Escherichia coli, as reported by Medscape Medical News, is seen by some as an example of the consequences of a loose policy.
Still, the American Gastroenterological Association (AGA) presented new, unpublished follow-up data at the meeting that showed that the majority of FMT patients in a national registry had no adverse events.
Some companies developing FMT-based products argued at the meeting that the agency should impose stricter requirements, while stool banks and clinicians offering the therapy outside of clinical trials said that the current policy – in place since 2013 – in which the FDA has exercised “enforcement discretion,” should be allowed to continue.
“Enforcement discretion has been successful in enabling and overcoming key barriers to access to treatment,” said Majdi Osman, MD, clinical program director at OpenBiome, a nonprofit stool bank based in Cambridge, Mass. Dr. Osman said that 98% of the U.S. population now lives within a 2-hour drive of an FMT provider.
Amanda Kabage, a researcher and donor program coordinator for the Microbiota Therapeutics program at the University of Minnesota in Minneapolis, and herself a former recipient of FMT, said she was in favor of continuing the FDA policy.
“If enforcement discretion were to go away, patients far sicker than I was will not have access. They’ll get sicker and they will die,” Ms. Kabage said.
But, she added, the FDA had missed an opportunity by not insisting on collecting outcomes and safety data. Minnesota has established a patient registry to do just that, and physicians cannot administer FMT unless they agree to participate, she said. In response, FDA panelists noted that the agency cannot mandate data collection under an enforcement policy.
Lee Jones, founder and chief executive officer of Rebiotix/Ferring, a biotech company focused on the development of microbiome-based therapeutics, argued for tighter restrictions, however, claiming that increased access – and the FDA policy – had led to a fourfold decrease in enrollment since the company began study of its lead FMT product, RBX2660, in 2013.
“We’re dealing with an orphan indication and the patients were hard to come by to begin with,” she said at the meeting. “Enforcement discretion has slowed our clinical development and delayed patient access to FDA-approved therapies by over 2 years.”
An investigator at the University of Texas Health Science Center at Houston, Herbert DuPont, MD, who has administered FMT and is conducting a trial for Rebiotix, said his center wanted the FDA policy to continue “allowing multiple groups to perform FMT for recurrent [Clostridium difficile], because of the incredible public health need.”
But, he added, “We’re very concerned about industry and ability to do clinical trials.”
Those trials are important, Dr. DuPont said. “I think we have to address very actively how industry can move these products through,” he said, “because all of us want to remove the F from FMT,” by isolating the necessary elements of the process while not having the risk sometimes associated with human stool.
Policy slow to evolve
“I’m frustrated that it’s taken over 6 years and three draft guidances to get us this far,” Christian John Lillis, executive director of the Peggy Lillis Foundation – a group dedicated to creating awareness about the dangers of C. difficile – said at the meeting.
Mr. Lillis said that probably several thousand deaths had been prevented through increased FMT access, but that it was time to create a concrete policy that advanced the therapy.
The FDA guidance issued in 2013 allowed physicians to provide FMT for recurrent or refractory C. difficile infection without filing an investigational new drug (IND) application.
Clinicians must obtain informed consent that includes a discussion of the risks, and a statement that FMT is investigational. In March 2016, the agency issued revised draft guidance that it was aiming to require stool banks to apply for INDs, as reported by Medscape Medical News.
OpenBiome has flourished under the current policy. It has provided more than 50,000 treatments to 1,200 hospitals and clinics, and has provided FMT for 49 clinical trials and for 16 single patients who received INDs, Dr. Osman said.
But requiring INDs for all centers is a bad idea, he said. “IND requirements are insurmountable for most health centers,” Dr. Osman said, noting that most of the FMT material OpenBiome produces is sent to community-based physicians.
“These requirements would likely mean restrictions in access for stool bank–provided FMT and potentially pushing patients to physician-directed FMT or discouraging physicians from using FMT at all,” he said.
Stacy Kahn, MD, FMT director at Boston Children’s Hospital in Massachusetts, said that having ready access from a stool bank was crucial.
“Universal donor FMT is much easier, much faster and much more cost effective than what we can do as clinicians,” she said.
New safety and efficacy data
One unpublished study showed that 75% of patients treated since 2011 had a sustained cure, noted Colleen Kelly, MD, a Brown University professor of medicine and principal investigator for the National Institutes of Health–funded national FMT registry (although the data in this study were not from the FMT registry).
The study, which was a collaboration between the Alpert Medical School of Brown University, Brigham and Women’s Hospital, and Indiana University School of Medicine, attempted follow-up on 533 patients; 208 were successfully contacted, and an additional 55 had died, none due to FMT.
Dr. Kelly also presented data from the FMT National Registry showing that at 1 month posttransplant, two (1%) of 253 patients had an infection possibly related to FMT; one with Bacteroides fragilis and one with enteropathogenic E. coli. Seven hospitalizations were deemed related or possibly related to FMT, including two recurrences of C. difficile.
At 6 months posttransplant, 8 (5%) of 152 patients had a serious infection, and 23 patients reported a diagnosis of a new condition, primarily diarrhea-predominant irritable bowel syndrome, which is common post FMT, said Dr. Kelly, who presented the data on behalf of AGA, which administers the registry.
The AGA supports a continuation of the enforcement discretion as a means to maintain patient access where the evidence supports the use of FMT, but the group does not back use of FMT outside medical supervision, Dr. Kelly said.
This article originally appeared on Medscape. For more news, follow Medscape on Facebook, Twitter, Instagram, and YouTube.
Pediatric quality measures initiatives gain momentum
The development of pediatric-specific quality measurements – especially those that focus on outcomes – has gained ground, although it is still hampered, in part, by the lack of electronic health records that are specific to pediatrics, say experts.
“Pediatric measures have historically lagged behind many of the adult measures,” said Dr. Ramesh Sachdeva, medical director for quality initiatives at the American Academy of Pediatrics and professor of pediatrics at the University of Wisconsin, Milwaukee.
In the adult population, the quest to encourage meaningful use of EHRs has spurred the blooming of a giant health IT industry, and the creation of adult-specific process and outcomes measures that populate adult-specific EHRs, said Dr. Sachdeva. Meaningful use has gained more widespread adoption among physicians treating Medicare patients – primarily adults – than among those treating Medicaid patients, which includes large numbers of children.
As of September 2014, some 431,000 eligible physicians had received incentive payments from Medicare for meaningful use since the beginning of the incentive program, according to the Centers for Medicare & Medicaid Services. By comparison, only 48,000 physicians have received Medicaid incentive payments since the start, said the CMS in a September report.
“We need to do some catch-up,” Dr. Sachdeva said in an interview.
Even among the biggest supporters of EHR use in the pediatric field, “development and implementation of functionality to promote quality of pediatric care specifically has been inconsistent,” according to a just-posted draft report on functionality of pediatric EHRs that was funded by the Agency for Healthcare Research and Quality. AHRQ, the AAP, and CMS all have issued sets of required elements for a pediatric EHR, such as immunization management; growth tracking; well-child visit tracking; medication dosing based on weight; data norms; and privacy, for adolescent populations, in particular.
“It is unclear whether pediatricians are adopting pediatric-specific tools, however,” said the AHRQ researchers. They found that only 31% of pediatricians use an EHR with basic functionality, and just 14% use a fully functional EHR. Only 8% of pediatricians are using a fully functional EHR with pediatric functionality.
A joint CMS-AAP effort – the Model Pediatric EHR – created over 700 pediatric functionality requirements. The “large number of requirements may have had a paralyzing effect on vendors,” wrote the researchers.
Jump-starting the quality effort
The federal government attempted to jump-start the measurement development process with the reauthorization of the Children’s Health Insurance Program in 2009. That law created the infrastructure and funding for the CMS and the AHRQ to establish the Pediatric Quality Measures Program.
The PQMP is made up of seven Centers of Excellence that are developing, testing, and then recommending quality measures for the outpatient and inpatient setting.
While there is increasing movement on developing both process and outcomes measures, “in order for quality measures to lead to improvement in health care, these measures must have clinical relevance to both pediatricians and families,” said Dr. Sachdeva, along with former AAP President Thomas McInerny and immediate past president AAP President James Perrin, in an article published in a recent Academic Pediatrics supplement that is devoted to the topic of quality in pediatrics (Acad. Pediatr. 2014;14(S): S10–11).
Karen A. Kuhlthau , of Massachusetts General Hospital, Boston, and colleagues from the AHRQ and the Children’s Hospital of Philadelphia, noted in another article that the value of measuring quality is no longer really questioned. “Measurement is a critical step toward achieving the triple aim of better care, better population health, and more affordable care,” they wrote (Acad. Pediatr. 2014;14(S): S1-3).
But they also discussed some of the challenges in developing those measures in the pediatric field; among those, that each Medicaid program may have a separate method of collecting data. The variety of methodologies makes it hard to standardize the conclusions and create a strong foundation for an evidence-based measure. Another avenue is patient-reported outcomes measures, which have the potential “for making measurement more meaningful by integrating the patient perspective and engaging more families in the quality enterprise,” wrote Dr. Kuhlthau and her colleagues. And yet, they have not “been extensively incorporated into quality measurement sets thus far.”
There are complications to including those viewpoints, wrote Dr. Christopher B. Forrest, a professor of pediatrics at Children’s Hospital of Philadelphia, and Dr. Jeffrey H. Silber, director of the Center for Outcomes Research at the hospital, in a separate paper (Acad. Pediatr.2014;14(S): S33-8).
“Patient and family priorities are not always aligned with clinician priorities for treatment outcomes,” wrote Dr. Forrest and Dr. Silber. In addition, “the perspective of the family varies markedly from that of society,” they said.
Ultimately, however, the value of care must include patient and family needs, Dr. Forrest and Dr. Silber wrote.
ADHD quality measure on horizon
Dr. Donna M. Woods noted that some 5 million children between ages 3 and 17 years have been diagnosed with the condition, and that the condition appears to be on the rise.
The first step was to conduct a systematic review of studies on the outcomes of ADHD treatments. That paper was published in the Academic Pediatrics supplement (Acad. Pediatr. 2014;14(S): S54-60). This type of review for ADHD therapies had never been done before, she said.
The gold standard for good quality ADHD care is improvement in symptoms, and every one of the 35 studies that met her study’s inclusion criteria showed improvement – regardless of whether it was a medication or behavioral therapy.
That literature review showed that “improvement in symptoms could provide the basis for the development of an outcome measure to assess the quality of care for pediatric patients diagnoses with ADHD,” Dr. Woods and her colleagues concluded.
Their work attracted some attention at CMS, which became interested in developing the outcome measure for stage 3 of meaningful use, Dr. Woods said.
The National Committee on Quality Assurance, along with a private consulting firm, has helped create such a measure and is now trying to test it, said Dr. Woods, who acted as an unpaid consultant for the project.
The testing has run into a bit of an obstacle – that it can’t really be incorporated into the adult-centric EHRs that are currently available.
EHRs, MOCs, ACOs all to help drive use
Even as pediatricians lag behind in use of EHRs – and as the market lags in providing a record that will allow them to measure what’s important in pediatrics – many clinicians are participating in quality through the maintenance of certification process.
There are 17 approved practice improvement modules (PIM) offered by the American Board of Pediatrics to clinicians who are maintaining their certification.
Among the ABP-approved PIMs are the ADHD initial diagnosis PIM and the ADHD follow-up PIM. Both are based on guidelines issued by the AAP in 2011.
“The maintenance of certification process is very important,” said Dr. Sachdeva, who said it was one of several things that would likely steer more pediatricians into adopting quality measures.
Also crucial is linking payment to quality, and the push toward integrated delivery systems such as accountable care organizations that will require quality documentation and improvement.
Dr. Sachdeva, Dr. McInerny, and Dr. Perrin wrote that to improve the quality of care and reduce the cost of care, it is critical “to assure that substantial numbers of these measures are adopted into the clinical practice of practicing pediatricians.”
This should not be too difficult, if they are given the right tools, said Dr. Sachdeva.
“I think the compelling argument for pediatricians is that it’s the right thing to do for children,” he said.
On Twitter @aliciaault
The development of pediatric-specific quality measurements – especially those that focus on outcomes – has gained ground, although it is still hampered, in part, by the lack of electronic health records that are specific to pediatrics, say experts.
“Pediatric measures have historically lagged behind many of the adult measures,” said Dr. Ramesh Sachdeva, medical director for quality initiatives at the American Academy of Pediatrics and professor of pediatrics at the University of Wisconsin, Milwaukee.
In the adult population, the quest to encourage meaningful use of EHRs has spurred the blooming of a giant health IT industry, and the creation of adult-specific process and outcomes measures that populate adult-specific EHRs, said Dr. Sachdeva. Meaningful use has gained more widespread adoption among physicians treating Medicare patients – primarily adults – than among those treating Medicaid patients, which includes large numbers of children.
As of September 2014, some 431,000 eligible physicians had received incentive payments from Medicare for meaningful use since the beginning of the incentive program, according to the Centers for Medicare & Medicaid Services. By comparison, only 48,000 physicians have received Medicaid incentive payments since the start, said the CMS in a September report.
“We need to do some catch-up,” Dr. Sachdeva said in an interview.
Even among the biggest supporters of EHR use in the pediatric field, “development and implementation of functionality to promote quality of pediatric care specifically has been inconsistent,” according to a just-posted draft report on functionality of pediatric EHRs that was funded by the Agency for Healthcare Research and Quality. AHRQ, the AAP, and CMS all have issued sets of required elements for a pediatric EHR, such as immunization management; growth tracking; well-child visit tracking; medication dosing based on weight; data norms; and privacy, for adolescent populations, in particular.
“It is unclear whether pediatricians are adopting pediatric-specific tools, however,” said the AHRQ researchers. They found that only 31% of pediatricians use an EHR with basic functionality, and just 14% use a fully functional EHR. Only 8% of pediatricians are using a fully functional EHR with pediatric functionality.
A joint CMS-AAP effort – the Model Pediatric EHR – created over 700 pediatric functionality requirements. The “large number of requirements may have had a paralyzing effect on vendors,” wrote the researchers.
Jump-starting the quality effort
The federal government attempted to jump-start the measurement development process with the reauthorization of the Children’s Health Insurance Program in 2009. That law created the infrastructure and funding for the CMS and the AHRQ to establish the Pediatric Quality Measures Program.
The PQMP is made up of seven Centers of Excellence that are developing, testing, and then recommending quality measures for the outpatient and inpatient setting.
While there is increasing movement on developing both process and outcomes measures, “in order for quality measures to lead to improvement in health care, these measures must have clinical relevance to both pediatricians and families,” said Dr. Sachdeva, along with former AAP President Thomas McInerny and immediate past president AAP President James Perrin, in an article published in a recent Academic Pediatrics supplement that is devoted to the topic of quality in pediatrics (Acad. Pediatr. 2014;14(S): S10–11).
Karen A. Kuhlthau , of Massachusetts General Hospital, Boston, and colleagues from the AHRQ and the Children’s Hospital of Philadelphia, noted in another article that the value of measuring quality is no longer really questioned. “Measurement is a critical step toward achieving the triple aim of better care, better population health, and more affordable care,” they wrote (Acad. Pediatr. 2014;14(S): S1-3).
But they also discussed some of the challenges in developing those measures in the pediatric field; among those, that each Medicaid program may have a separate method of collecting data. The variety of methodologies makes it hard to standardize the conclusions and create a strong foundation for an evidence-based measure. Another avenue is patient-reported outcomes measures, which have the potential “for making measurement more meaningful by integrating the patient perspective and engaging more families in the quality enterprise,” wrote Dr. Kuhlthau and her colleagues. And yet, they have not “been extensively incorporated into quality measurement sets thus far.”
There are complications to including those viewpoints, wrote Dr. Christopher B. Forrest, a professor of pediatrics at Children’s Hospital of Philadelphia, and Dr. Jeffrey H. Silber, director of the Center for Outcomes Research at the hospital, in a separate paper (Acad. Pediatr.2014;14(S): S33-8).
“Patient and family priorities are not always aligned with clinician priorities for treatment outcomes,” wrote Dr. Forrest and Dr. Silber. In addition, “the perspective of the family varies markedly from that of society,” they said.
Ultimately, however, the value of care must include patient and family needs, Dr. Forrest and Dr. Silber wrote.
ADHD quality measure on horizon
Dr. Donna M. Woods noted that some 5 million children between ages 3 and 17 years have been diagnosed with the condition, and that the condition appears to be on the rise.
The first step was to conduct a systematic review of studies on the outcomes of ADHD treatments. That paper was published in the Academic Pediatrics supplement (Acad. Pediatr. 2014;14(S): S54-60). This type of review for ADHD therapies had never been done before, she said.
The gold standard for good quality ADHD care is improvement in symptoms, and every one of the 35 studies that met her study’s inclusion criteria showed improvement – regardless of whether it was a medication or behavioral therapy.
That literature review showed that “improvement in symptoms could provide the basis for the development of an outcome measure to assess the quality of care for pediatric patients diagnoses with ADHD,” Dr. Woods and her colleagues concluded.
Their work attracted some attention at CMS, which became interested in developing the outcome measure for stage 3 of meaningful use, Dr. Woods said.
The National Committee on Quality Assurance, along with a private consulting firm, has helped create such a measure and is now trying to test it, said Dr. Woods, who acted as an unpaid consultant for the project.
The testing has run into a bit of an obstacle – that it can’t really be incorporated into the adult-centric EHRs that are currently available.
EHRs, MOCs, ACOs all to help drive use
Even as pediatricians lag behind in use of EHRs – and as the market lags in providing a record that will allow them to measure what’s important in pediatrics – many clinicians are participating in quality through the maintenance of certification process.
There are 17 approved practice improvement modules (PIM) offered by the American Board of Pediatrics to clinicians who are maintaining their certification.
Among the ABP-approved PIMs are the ADHD initial diagnosis PIM and the ADHD follow-up PIM. Both are based on guidelines issued by the AAP in 2011.
“The maintenance of certification process is very important,” said Dr. Sachdeva, who said it was one of several things that would likely steer more pediatricians into adopting quality measures.
Also crucial is linking payment to quality, and the push toward integrated delivery systems such as accountable care organizations that will require quality documentation and improvement.
Dr. Sachdeva, Dr. McInerny, and Dr. Perrin wrote that to improve the quality of care and reduce the cost of care, it is critical “to assure that substantial numbers of these measures are adopted into the clinical practice of practicing pediatricians.”
This should not be too difficult, if they are given the right tools, said Dr. Sachdeva.
“I think the compelling argument for pediatricians is that it’s the right thing to do for children,” he said.
On Twitter @aliciaault
The development of pediatric-specific quality measurements – especially those that focus on outcomes – has gained ground, although it is still hampered, in part, by the lack of electronic health records that are specific to pediatrics, say experts.
“Pediatric measures have historically lagged behind many of the adult measures,” said Dr. Ramesh Sachdeva, medical director for quality initiatives at the American Academy of Pediatrics and professor of pediatrics at the University of Wisconsin, Milwaukee.
In the adult population, the quest to encourage meaningful use of EHRs has spurred the blooming of a giant health IT industry, and the creation of adult-specific process and outcomes measures that populate adult-specific EHRs, said Dr. Sachdeva. Meaningful use has gained more widespread adoption among physicians treating Medicare patients – primarily adults – than among those treating Medicaid patients, which includes large numbers of children.
As of September 2014, some 431,000 eligible physicians had received incentive payments from Medicare for meaningful use since the beginning of the incentive program, according to the Centers for Medicare & Medicaid Services. By comparison, only 48,000 physicians have received Medicaid incentive payments since the start, said the CMS in a September report.
“We need to do some catch-up,” Dr. Sachdeva said in an interview.
Even among the biggest supporters of EHR use in the pediatric field, “development and implementation of functionality to promote quality of pediatric care specifically has been inconsistent,” according to a just-posted draft report on functionality of pediatric EHRs that was funded by the Agency for Healthcare Research and Quality. AHRQ, the AAP, and CMS all have issued sets of required elements for a pediatric EHR, such as immunization management; growth tracking; well-child visit tracking; medication dosing based on weight; data norms; and privacy, for adolescent populations, in particular.
“It is unclear whether pediatricians are adopting pediatric-specific tools, however,” said the AHRQ researchers. They found that only 31% of pediatricians use an EHR with basic functionality, and just 14% use a fully functional EHR. Only 8% of pediatricians are using a fully functional EHR with pediatric functionality.
A joint CMS-AAP effort – the Model Pediatric EHR – created over 700 pediatric functionality requirements. The “large number of requirements may have had a paralyzing effect on vendors,” wrote the researchers.
Jump-starting the quality effort
The federal government attempted to jump-start the measurement development process with the reauthorization of the Children’s Health Insurance Program in 2009. That law created the infrastructure and funding for the CMS and the AHRQ to establish the Pediatric Quality Measures Program.
The PQMP is made up of seven Centers of Excellence that are developing, testing, and then recommending quality measures for the outpatient and inpatient setting.
While there is increasing movement on developing both process and outcomes measures, “in order for quality measures to lead to improvement in health care, these measures must have clinical relevance to both pediatricians and families,” said Dr. Sachdeva, along with former AAP President Thomas McInerny and immediate past president AAP President James Perrin, in an article published in a recent Academic Pediatrics supplement that is devoted to the topic of quality in pediatrics (Acad. Pediatr. 2014;14(S): S10–11).
Karen A. Kuhlthau , of Massachusetts General Hospital, Boston, and colleagues from the AHRQ and the Children’s Hospital of Philadelphia, noted in another article that the value of measuring quality is no longer really questioned. “Measurement is a critical step toward achieving the triple aim of better care, better population health, and more affordable care,” they wrote (Acad. Pediatr. 2014;14(S): S1-3).
But they also discussed some of the challenges in developing those measures in the pediatric field; among those, that each Medicaid program may have a separate method of collecting data. The variety of methodologies makes it hard to standardize the conclusions and create a strong foundation for an evidence-based measure. Another avenue is patient-reported outcomes measures, which have the potential “for making measurement more meaningful by integrating the patient perspective and engaging more families in the quality enterprise,” wrote Dr. Kuhlthau and her colleagues. And yet, they have not “been extensively incorporated into quality measurement sets thus far.”
There are complications to including those viewpoints, wrote Dr. Christopher B. Forrest, a professor of pediatrics at Children’s Hospital of Philadelphia, and Dr. Jeffrey H. Silber, director of the Center for Outcomes Research at the hospital, in a separate paper (Acad. Pediatr.2014;14(S): S33-8).
“Patient and family priorities are not always aligned with clinician priorities for treatment outcomes,” wrote Dr. Forrest and Dr. Silber. In addition, “the perspective of the family varies markedly from that of society,” they said.
Ultimately, however, the value of care must include patient and family needs, Dr. Forrest and Dr. Silber wrote.
ADHD quality measure on horizon
Dr. Donna M. Woods noted that some 5 million children between ages 3 and 17 years have been diagnosed with the condition, and that the condition appears to be on the rise.
The first step was to conduct a systematic review of studies on the outcomes of ADHD treatments. That paper was published in the Academic Pediatrics supplement (Acad. Pediatr. 2014;14(S): S54-60). This type of review for ADHD therapies had never been done before, she said.
The gold standard for good quality ADHD care is improvement in symptoms, and every one of the 35 studies that met her study’s inclusion criteria showed improvement – regardless of whether it was a medication or behavioral therapy.
That literature review showed that “improvement in symptoms could provide the basis for the development of an outcome measure to assess the quality of care for pediatric patients diagnoses with ADHD,” Dr. Woods and her colleagues concluded.
Their work attracted some attention at CMS, which became interested in developing the outcome measure for stage 3 of meaningful use, Dr. Woods said.
The National Committee on Quality Assurance, along with a private consulting firm, has helped create such a measure and is now trying to test it, said Dr. Woods, who acted as an unpaid consultant for the project.
The testing has run into a bit of an obstacle – that it can’t really be incorporated into the adult-centric EHRs that are currently available.
EHRs, MOCs, ACOs all to help drive use
Even as pediatricians lag behind in use of EHRs – and as the market lags in providing a record that will allow them to measure what’s important in pediatrics – many clinicians are participating in quality through the maintenance of certification process.
There are 17 approved practice improvement modules (PIM) offered by the American Board of Pediatrics to clinicians who are maintaining their certification.
Among the ABP-approved PIMs are the ADHD initial diagnosis PIM and the ADHD follow-up PIM. Both are based on guidelines issued by the AAP in 2011.
“The maintenance of certification process is very important,” said Dr. Sachdeva, who said it was one of several things that would likely steer more pediatricians into adopting quality measures.
Also crucial is linking payment to quality, and the push toward integrated delivery systems such as accountable care organizations that will require quality documentation and improvement.
Dr. Sachdeva, Dr. McInerny, and Dr. Perrin wrote that to improve the quality of care and reduce the cost of care, it is critical “to assure that substantial numbers of these measures are adopted into the clinical practice of practicing pediatricians.”
This should not be too difficult, if they are given the right tools, said Dr. Sachdeva.
“I think the compelling argument for pediatricians is that it’s the right thing to do for children,” he said.
On Twitter @aliciaault
FDA approves finafloxacin for swimmer’s ear
The Food and Drug Administration has approved finafloxacin otic suspension to treat acute otitis externa caused by Pseudomonas aeruginosa and Staphylococcus aureus.
The suspension joins several other antibacterials already approved to treat swimmer’s ear.
“The availability of multiple treatment options allows physicians and patients to find the treatment to meet their needs,” Dr. Edward Cox, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, said in a statement.
Safety and efficacy were established in two studies. A total of 1,234 participants aged 6 months and 85 years were randomly assigned to receive finafloxacin or vehicle. About half had confirmed P. aeruginosa or S. aureus; of those 70% who were given finafloxacin had clinical cure, defined as complete resolution of ear tenderness, redness, and swelling. Patients who received the vehicle alone achieved a 37% cure rate.
Finafloxacin was also superior to the vehicle for clearing the bacteria and eased ear pain sooner, according to the FDA statement.
The most common side effects were ear pruritus and nausea.
Alcon Laboratories will market finafloxacin otic suspension as Xtoro.
On Twitter @aliciaault
The Food and Drug Administration has approved finafloxacin otic suspension to treat acute otitis externa caused by Pseudomonas aeruginosa and Staphylococcus aureus.
The suspension joins several other antibacterials already approved to treat swimmer’s ear.
“The availability of multiple treatment options allows physicians and patients to find the treatment to meet their needs,” Dr. Edward Cox, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, said in a statement.
Safety and efficacy were established in two studies. A total of 1,234 participants aged 6 months and 85 years were randomly assigned to receive finafloxacin or vehicle. About half had confirmed P. aeruginosa or S. aureus; of those 70% who were given finafloxacin had clinical cure, defined as complete resolution of ear tenderness, redness, and swelling. Patients who received the vehicle alone achieved a 37% cure rate.
Finafloxacin was also superior to the vehicle for clearing the bacteria and eased ear pain sooner, according to the FDA statement.
The most common side effects were ear pruritus and nausea.
Alcon Laboratories will market finafloxacin otic suspension as Xtoro.
On Twitter @aliciaault
The Food and Drug Administration has approved finafloxacin otic suspension to treat acute otitis externa caused by Pseudomonas aeruginosa and Staphylococcus aureus.
The suspension joins several other antibacterials already approved to treat swimmer’s ear.
“The availability of multiple treatment options allows physicians and patients to find the treatment to meet their needs,” Dr. Edward Cox, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, said in a statement.
Safety and efficacy were established in two studies. A total of 1,234 participants aged 6 months and 85 years were randomly assigned to receive finafloxacin or vehicle. About half had confirmed P. aeruginosa or S. aureus; of those 70% who were given finafloxacin had clinical cure, defined as complete resolution of ear tenderness, redness, and swelling. Patients who received the vehicle alone achieved a 37% cure rate.
Finafloxacin was also superior to the vehicle for clearing the bacteria and eased ear pain sooner, according to the FDA statement.
The most common side effects were ear pruritus and nausea.
Alcon Laboratories will market finafloxacin otic suspension as Xtoro.
On Twitter @aliciaault
Alzheimer’s a winner in federal spending bill
*Article updated 12/18/14
The massive $1.1 trillion spending bill that was approved by Congress before it left for an extended recess included several provisions aimed at bolstering Alzheimer’s disease research.
The bill, signed into law by President Obama on Dec. 16, fully incorporated the Alzheimer’s Accountability Act. That bipartisan proposal requires the director of the National Institutes of Health to submit an annual budget to Congress until 2025, spelling out the amount of money needed to meet each milestone of the National Plan to Address Alzheimer’s Disease.
The Alzheimer’s Accountability Act (H.R. 4351/S. 2192) was introduced in April.
“The Alzheimer’s Association urged the introduction and passage of this Act so that Congress understands what science will bring us to the day when there will be survivors of Alzheimer’s, just as there now are for the other major diseases in our country,” said Harry Johns, president and CEO of the Alzheimer’s Association, in a statement after the spending bill’s passage.
“It facilitates a dialog between the people doing the research and the people doing the appropriations,” said Dr. Daniel C. Potts, associate clinical professor at the University of Alabama, Tuscaloosa, and a member of the American Academy of Neurology’s Government Relations Committee.
The Association said that the Accountability Act creates “a mechanism that will utilize rigorous scientific judgment, rather than shifting political interests and unforeseen events, to guide Congressional funding allocations.”
The federal spending bill, which keeps the government funded through Sept. 30, 2015, also includes a $25 million increase for Alzheimer’s research, according to the Alzheimer’s Association. The group noted that this year’s increase comes after a $122 million increase in fiscal 2014. Altogether, federal funding for Alzheimer’s research stands at $591 million.
But that is not enough, the association said. “According to leading experts, we must dramatically increase research funding to accomplish the primary goal of the National Alzheimer’s Plan to prevent and effectively treat Alzheimer’s by 2025,” Mr. Johns said.
“We’re woefully, woefully underfunding Alzheimer’s disease compared with other leading causes of morbidity and mortality in this country,” Dr. Potts agreed. But he said that the additional funding this year – and a bipartisan agreement to focus more on scientific, rather than political, priorities are a step in the right direction.
Alzheimer’s is a “sociocultural atom bomb,” said Dr. Potts, adding, “I think people are beginning to realize this.”
On Twitter @aliciaault
*Article updated 12/18/14
The massive $1.1 trillion spending bill that was approved by Congress before it left for an extended recess included several provisions aimed at bolstering Alzheimer’s disease research.
The bill, signed into law by President Obama on Dec. 16, fully incorporated the Alzheimer’s Accountability Act. That bipartisan proposal requires the director of the National Institutes of Health to submit an annual budget to Congress until 2025, spelling out the amount of money needed to meet each milestone of the National Plan to Address Alzheimer’s Disease.
The Alzheimer’s Accountability Act (H.R. 4351/S. 2192) was introduced in April.
“The Alzheimer’s Association urged the introduction and passage of this Act so that Congress understands what science will bring us to the day when there will be survivors of Alzheimer’s, just as there now are for the other major diseases in our country,” said Harry Johns, president and CEO of the Alzheimer’s Association, in a statement after the spending bill’s passage.
“It facilitates a dialog between the people doing the research and the people doing the appropriations,” said Dr. Daniel C. Potts, associate clinical professor at the University of Alabama, Tuscaloosa, and a member of the American Academy of Neurology’s Government Relations Committee.
The Association said that the Accountability Act creates “a mechanism that will utilize rigorous scientific judgment, rather than shifting political interests and unforeseen events, to guide Congressional funding allocations.”
The federal spending bill, which keeps the government funded through Sept. 30, 2015, also includes a $25 million increase for Alzheimer’s research, according to the Alzheimer’s Association. The group noted that this year’s increase comes after a $122 million increase in fiscal 2014. Altogether, federal funding for Alzheimer’s research stands at $591 million.
But that is not enough, the association said. “According to leading experts, we must dramatically increase research funding to accomplish the primary goal of the National Alzheimer’s Plan to prevent and effectively treat Alzheimer’s by 2025,” Mr. Johns said.
“We’re woefully, woefully underfunding Alzheimer’s disease compared with other leading causes of morbidity and mortality in this country,” Dr. Potts agreed. But he said that the additional funding this year – and a bipartisan agreement to focus more on scientific, rather than political, priorities are a step in the right direction.
Alzheimer’s is a “sociocultural atom bomb,” said Dr. Potts, adding, “I think people are beginning to realize this.”
On Twitter @aliciaault
*Article updated 12/18/14
The massive $1.1 trillion spending bill that was approved by Congress before it left for an extended recess included several provisions aimed at bolstering Alzheimer’s disease research.
The bill, signed into law by President Obama on Dec. 16, fully incorporated the Alzheimer’s Accountability Act. That bipartisan proposal requires the director of the National Institutes of Health to submit an annual budget to Congress until 2025, spelling out the amount of money needed to meet each milestone of the National Plan to Address Alzheimer’s Disease.
The Alzheimer’s Accountability Act (H.R. 4351/S. 2192) was introduced in April.
“The Alzheimer’s Association urged the introduction and passage of this Act so that Congress understands what science will bring us to the day when there will be survivors of Alzheimer’s, just as there now are for the other major diseases in our country,” said Harry Johns, president and CEO of the Alzheimer’s Association, in a statement after the spending bill’s passage.
“It facilitates a dialog between the people doing the research and the people doing the appropriations,” said Dr. Daniel C. Potts, associate clinical professor at the University of Alabama, Tuscaloosa, and a member of the American Academy of Neurology’s Government Relations Committee.
The Association said that the Accountability Act creates “a mechanism that will utilize rigorous scientific judgment, rather than shifting political interests and unforeseen events, to guide Congressional funding allocations.”
The federal spending bill, which keeps the government funded through Sept. 30, 2015, also includes a $25 million increase for Alzheimer’s research, according to the Alzheimer’s Association. The group noted that this year’s increase comes after a $122 million increase in fiscal 2014. Altogether, federal funding for Alzheimer’s research stands at $591 million.
But that is not enough, the association said. “According to leading experts, we must dramatically increase research funding to accomplish the primary goal of the National Alzheimer’s Plan to prevent and effectively treat Alzheimer’s by 2025,” Mr. Johns said.
“We’re woefully, woefully underfunding Alzheimer’s disease compared with other leading causes of morbidity and mortality in this country,” Dr. Potts agreed. But he said that the additional funding this year – and a bipartisan agreement to focus more on scientific, rather than political, priorities are a step in the right direction.
Alzheimer’s is a “sociocultural atom bomb,” said Dr. Potts, adding, “I think people are beginning to realize this.”
On Twitter @aliciaault
Senate confirms Murthy as Surgeon General
Boston hospitalist Dr. Vivek Murthy was confirmed Dec. 15 as the 19th U.S. Surgeon General, by a 51-43 vote of the U.S. Senate.
“Being ‘America’s doctor’ requires many of the same traits required of hospitalists: leadership, sharp clinical skills, and the ability to engage with patients,” Dr. Burke Kealey, president of the Society of Hospital Medicine, said in a statement. “Like hospitalists in thousands of hospitals across the country, I am confident Dr. Murthy will become an agent of change to improve delivery of care in our country.”
“As a practicing physician, Dr. Murthy brings extensive clinical expertise caring for patients and training hundreds of medical residents,” Dr. Robert L. Wergin, president of the American Academy of Family Physicians, said in a statement. “Dr. Murthy demonstrates a clear and thoughtful understanding of how important it is to transform our health care system from one focused on sick care to one based on wellness, good health practices, and early intervention.”
Dr. Murthy was nominated by President Obama in November 2013 and got fairly light treatment at a Senate confirmation hearing in February 2014. But Republican senators refused to entertain a confirmation vote for a variety of reasons, with Dr. Murthy’s advocacy on gun violence being cited most often. They also objected to his activist role in the passage of the Affordable Care Act while president of Doctors for America and his campaigning for Mr. Obama in the 2008 presidential election.
“The majority of his career has not been spent as a doctor treating patients, but as an activist,” said Sen. John Barrasso (R-Wyo.) in a speech before the confirmation vote.
But Sen. Dick Durbin (D-Ill.) called Dr. Murthy an outstanding physician and a public health expert, and noted that he had received the backing of some 100 health-related organizations earlier this year, including the American College of Physicians, the AAFP, the American Academy of Pediatrics, the American Cancer Society, the American Hospital Association, the American Diabetes Association, and many others.
Sen. Mark Kirk (Ill.) was the only Republican to vote to confirm Dr. Murthy, while three Democrats voted against him: Sen. Joe Donnelly (Ind.), Sen. Heidi Heitkamp (N.D.), and Sen. Joe Manchin (W.Va.). There were 6 abstentions.
The ACP reiterated its support for Dr. Murthy, citing a Feburary letter to two Senate committee chairmen in which college leaders called Dr. Murthy “a strong advocate for the provision of health insurance coverage to all Americans and ... a proven leader who can build coalitions among diverse individuals to ensure better health for our communities.”
The ACP statement also highlighted Dr. Murthy’s extensive public health experience, including serving on the U.S. Presidential Advisory Council on Prevention, Health Promotion, and Integrative and Public Health; cofounding VISIONS Worldwide in 1995, a nonprofit organization focused on HIV/AIDS education in India and the U.S.; and cofounding TrialNetworks, aimed at optimizing the quality and efficiency of clinical trials.
The nation has been without a confirmed surgeon general since Dr. Regina M. Benjamin retired in 2013.
On Twitter @aliciaault
Boston hospitalist Dr. Vivek Murthy was confirmed Dec. 15 as the 19th U.S. Surgeon General, by a 51-43 vote of the U.S. Senate.
“Being ‘America’s doctor’ requires many of the same traits required of hospitalists: leadership, sharp clinical skills, and the ability to engage with patients,” Dr. Burke Kealey, president of the Society of Hospital Medicine, said in a statement. “Like hospitalists in thousands of hospitals across the country, I am confident Dr. Murthy will become an agent of change to improve delivery of care in our country.”
“As a practicing physician, Dr. Murthy brings extensive clinical expertise caring for patients and training hundreds of medical residents,” Dr. Robert L. Wergin, president of the American Academy of Family Physicians, said in a statement. “Dr. Murthy demonstrates a clear and thoughtful understanding of how important it is to transform our health care system from one focused on sick care to one based on wellness, good health practices, and early intervention.”
Dr. Murthy was nominated by President Obama in November 2013 and got fairly light treatment at a Senate confirmation hearing in February 2014. But Republican senators refused to entertain a confirmation vote for a variety of reasons, with Dr. Murthy’s advocacy on gun violence being cited most often. They also objected to his activist role in the passage of the Affordable Care Act while president of Doctors for America and his campaigning for Mr. Obama in the 2008 presidential election.
“The majority of his career has not been spent as a doctor treating patients, but as an activist,” said Sen. John Barrasso (R-Wyo.) in a speech before the confirmation vote.
But Sen. Dick Durbin (D-Ill.) called Dr. Murthy an outstanding physician and a public health expert, and noted that he had received the backing of some 100 health-related organizations earlier this year, including the American College of Physicians, the AAFP, the American Academy of Pediatrics, the American Cancer Society, the American Hospital Association, the American Diabetes Association, and many others.
Sen. Mark Kirk (Ill.) was the only Republican to vote to confirm Dr. Murthy, while three Democrats voted against him: Sen. Joe Donnelly (Ind.), Sen. Heidi Heitkamp (N.D.), and Sen. Joe Manchin (W.Va.). There were 6 abstentions.
The ACP reiterated its support for Dr. Murthy, citing a Feburary letter to two Senate committee chairmen in which college leaders called Dr. Murthy “a strong advocate for the provision of health insurance coverage to all Americans and ... a proven leader who can build coalitions among diverse individuals to ensure better health for our communities.”
The ACP statement also highlighted Dr. Murthy’s extensive public health experience, including serving on the U.S. Presidential Advisory Council on Prevention, Health Promotion, and Integrative and Public Health; cofounding VISIONS Worldwide in 1995, a nonprofit organization focused on HIV/AIDS education in India and the U.S.; and cofounding TrialNetworks, aimed at optimizing the quality and efficiency of clinical trials.
The nation has been without a confirmed surgeon general since Dr. Regina M. Benjamin retired in 2013.
On Twitter @aliciaault
Boston hospitalist Dr. Vivek Murthy was confirmed Dec. 15 as the 19th U.S. Surgeon General, by a 51-43 vote of the U.S. Senate.
“Being ‘America’s doctor’ requires many of the same traits required of hospitalists: leadership, sharp clinical skills, and the ability to engage with patients,” Dr. Burke Kealey, president of the Society of Hospital Medicine, said in a statement. “Like hospitalists in thousands of hospitals across the country, I am confident Dr. Murthy will become an agent of change to improve delivery of care in our country.”
“As a practicing physician, Dr. Murthy brings extensive clinical expertise caring for patients and training hundreds of medical residents,” Dr. Robert L. Wergin, president of the American Academy of Family Physicians, said in a statement. “Dr. Murthy demonstrates a clear and thoughtful understanding of how important it is to transform our health care system from one focused on sick care to one based on wellness, good health practices, and early intervention.”
Dr. Murthy was nominated by President Obama in November 2013 and got fairly light treatment at a Senate confirmation hearing in February 2014. But Republican senators refused to entertain a confirmation vote for a variety of reasons, with Dr. Murthy’s advocacy on gun violence being cited most often. They also objected to his activist role in the passage of the Affordable Care Act while president of Doctors for America and his campaigning for Mr. Obama in the 2008 presidential election.
“The majority of his career has not been spent as a doctor treating patients, but as an activist,” said Sen. John Barrasso (R-Wyo.) in a speech before the confirmation vote.
But Sen. Dick Durbin (D-Ill.) called Dr. Murthy an outstanding physician and a public health expert, and noted that he had received the backing of some 100 health-related organizations earlier this year, including the American College of Physicians, the AAFP, the American Academy of Pediatrics, the American Cancer Society, the American Hospital Association, the American Diabetes Association, and many others.
Sen. Mark Kirk (Ill.) was the only Republican to vote to confirm Dr. Murthy, while three Democrats voted against him: Sen. Joe Donnelly (Ind.), Sen. Heidi Heitkamp (N.D.), and Sen. Joe Manchin (W.Va.). There were 6 abstentions.
The ACP reiterated its support for Dr. Murthy, citing a Feburary letter to two Senate committee chairmen in which college leaders called Dr. Murthy “a strong advocate for the provision of health insurance coverage to all Americans and ... a proven leader who can build coalitions among diverse individuals to ensure better health for our communities.”
The ACP statement also highlighted Dr. Murthy’s extensive public health experience, including serving on the U.S. Presidential Advisory Council on Prevention, Health Promotion, and Integrative and Public Health; cofounding VISIONS Worldwide in 1995, a nonprofit organization focused on HIV/AIDS education in India and the U.S.; and cofounding TrialNetworks, aimed at optimizing the quality and efficiency of clinical trials.
The nation has been without a confirmed surgeon general since Dr. Regina M. Benjamin retired in 2013.
On Twitter @aliciaault
FDA approves newborn screening test for SCID
The Food and Drug Administration has approved a screening test for severe combined immunodeficiency in newborns.
It is the first such screening test to receive FDA approval. A laboratory-developed screen has been used over the last several years.
The test approved by the FDA on Dec. 15 – the EnLite neonatal TREC kit – uses a few drops of blood taken from the newborn’s heel, which are then dried on filter paper. The kit determines whether T-cell receptor excision circles (TRECs) DNA is low or missing. According to the FDA, newborns with severe combined immunodeficiency (SCID) typically have zero or low amounts of TREC DNA. The EnLite is just a screen. Additional testing is required for a SCID diagnosis.
Severe combined immunodeficiency is extremely rare. The FDA said there are only 40-100 new cases identified in the United States each year. Babies with SCID usually develop life-threatening infections within a few months, but early detection and treatment can improve survival, the agency said.
In 2010, the secretary of the Department of Health and Human Services added SCID to the national Recommended Uniform Screening Panel for newborns.
According to the Immune Deficiency Foundation, 25 states, Washington, D.C., and the Navajo Nation currently screen for SCID, while 18 states and territories have said they will begin testing soon.
Some states require that their newborn screening program use an FDA-approved or FDA-cleared test, according to the FDA.
The newly approved test “will enable states to incorporate an FDA-reviewed SCID test into their standard newborn screening panels and allow earlier identification for affected individuals,” Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, said in a statement.
The FDA found that the EnLite test correctly identified 17 of 17 SCID cases in a study of 6,400 blood spot specimens from routine screening of newborns. The test also was able to adequately detect very low TREC DNA values that are associated with SCID, according to the agency.
The EnLite neonatal TREC kit is manufactured by Wallac Oy, a subsidiary of PerkinElmer. A PerkinElmer spokesman said the test is available immediately in the United States.
On Twitter @aliciaault
The Food and Drug Administration has approved a screening test for severe combined immunodeficiency in newborns.
It is the first such screening test to receive FDA approval. A laboratory-developed screen has been used over the last several years.
The test approved by the FDA on Dec. 15 – the EnLite neonatal TREC kit – uses a few drops of blood taken from the newborn’s heel, which are then dried on filter paper. The kit determines whether T-cell receptor excision circles (TRECs) DNA is low or missing. According to the FDA, newborns with severe combined immunodeficiency (SCID) typically have zero or low amounts of TREC DNA. The EnLite is just a screen. Additional testing is required for a SCID diagnosis.
Severe combined immunodeficiency is extremely rare. The FDA said there are only 40-100 new cases identified in the United States each year. Babies with SCID usually develop life-threatening infections within a few months, but early detection and treatment can improve survival, the agency said.
In 2010, the secretary of the Department of Health and Human Services added SCID to the national Recommended Uniform Screening Panel for newborns.
According to the Immune Deficiency Foundation, 25 states, Washington, D.C., and the Navajo Nation currently screen for SCID, while 18 states and territories have said they will begin testing soon.
Some states require that their newborn screening program use an FDA-approved or FDA-cleared test, according to the FDA.
The newly approved test “will enable states to incorporate an FDA-reviewed SCID test into their standard newborn screening panels and allow earlier identification for affected individuals,” Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, said in a statement.
The FDA found that the EnLite test correctly identified 17 of 17 SCID cases in a study of 6,400 blood spot specimens from routine screening of newborns. The test also was able to adequately detect very low TREC DNA values that are associated with SCID, according to the agency.
The EnLite neonatal TREC kit is manufactured by Wallac Oy, a subsidiary of PerkinElmer. A PerkinElmer spokesman said the test is available immediately in the United States.
On Twitter @aliciaault
The Food and Drug Administration has approved a screening test for severe combined immunodeficiency in newborns.
It is the first such screening test to receive FDA approval. A laboratory-developed screen has been used over the last several years.
The test approved by the FDA on Dec. 15 – the EnLite neonatal TREC kit – uses a few drops of blood taken from the newborn’s heel, which are then dried on filter paper. The kit determines whether T-cell receptor excision circles (TRECs) DNA is low or missing. According to the FDA, newborns with severe combined immunodeficiency (SCID) typically have zero or low amounts of TREC DNA. The EnLite is just a screen. Additional testing is required for a SCID diagnosis.
Severe combined immunodeficiency is extremely rare. The FDA said there are only 40-100 new cases identified in the United States each year. Babies with SCID usually develop life-threatening infections within a few months, but early detection and treatment can improve survival, the agency said.
In 2010, the secretary of the Department of Health and Human Services added SCID to the national Recommended Uniform Screening Panel for newborns.
According to the Immune Deficiency Foundation, 25 states, Washington, D.C., and the Navajo Nation currently screen for SCID, while 18 states and territories have said they will begin testing soon.
Some states require that their newborn screening program use an FDA-approved or FDA-cleared test, according to the FDA.
The newly approved test “will enable states to incorporate an FDA-reviewed SCID test into their standard newborn screening panels and allow earlier identification for affected individuals,” Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, said in a statement.
The FDA found that the EnLite test correctly identified 17 of 17 SCID cases in a study of 6,400 blood spot specimens from routine screening of newborns. The test also was able to adequately detect very low TREC DNA values that are associated with SCID, according to the agency.
The EnLite neonatal TREC kit is manufactured by Wallac Oy, a subsidiary of PerkinElmer. A PerkinElmer spokesman said the test is available immediately in the United States.
On Twitter @aliciaault
