Vascular Specialist

Appellate judges appeared to doubt that the Affordable Care Act should survive without the law’s signature insurance mandate during oral arguments on July 9, in a highly watched legal battle that may upend the health care law.

During the 2-hour hearing, a three-judge panel for the 5th U.S. Circuit Court of Appeals peppered attorneys with questions about whether Congress intended the ACA to function without the individual mandate, and the panel seemed doubtful the law can stand if the regulation is parsed, according to an audio transcript of the arguments. As written, the individual mandate required that all Americans have insurance or pay a tax penalty. However, budget legislation in 2017 zeroed out the penalties associated with the mandate, rendering it unenforceable.

Appeals Judge Kurt Engelhardt, a President Trump appointee, asked defense attorney Samuel Siegel why Congress failed to add a clause in the original law that would have allowed ACA components to be severed if such sectioning was acceptable.

“Congress could have included a severability clause when it adopted the ACA in 2010. Couldn’t it have done so?” Judge Engelhardt asked during oral arguments. “It seems like it did the opposite, where it said, ‘This is a complete overhaul,’ and it set forth a bunch of factual findings. Couldn’t Congress have said, ‘Oh by the way, we think all of these provisions are such excellent ideas and helpful to the public that if any go by the wayside, then we would want the remainder to continue to apply’?”

Congress’s silence on the severing of the ACA does not create a presumption against parsing of the law, argued Mr. Siegel, who is representing the Democratic states suing to retain the ACA in Texas v. United States. He emphasized that in 2017, when Congress terminated the individual mandate penalty, it chose not to repeal preexisting protections or other important reforms instituted by the ACA.

“With that action, your Honor, Congress expressed its views that the individual marketplace and indeed the entire Affordable Care Act can operate without an enforceable individual mandate,” Mr. Siegel said. “We think that’s all this court needs to know to resolve the severability question.”

However, Appellate Judge Jennifer Elrod, a President George W. Bush appointee to the court, questioned whether legislators zeroed out the mandate penalty because they knew the law could not survive without the core provision. She surmised that Congress might have assumed, “Aha, this is the silver bullet that’s going to undo Obamacare.”

Kyle Hawkins, an attorney representing the Republican-led plaintiff states, meanwhile, argued the text of the ACA clearly declares the individual mandate essential to the law and to the goals that Congress intended to achieve.

“The Obama administration thought of that as an inseverable clause,” Mr. Hawkins argued. “The district court directly synthesized those considerations ... and it reached the correct conclusion: The individual mandate is unconstitutional and it is inseverable from the remainder of the law.”

Texas v. United States stems from a legal challenge by a group of 18 Republican state attorneys general and two individuals in 2018 who argue the ACA should be declared unconstitutional. The plaintiffs say that, because budget legislation in 2017 effectively eliminated the penalty associated with the mandate, the requirement itself is invalid. Without the mandate, the entire law must fall, the plaintiffs contend. The Department of Justice declined to fully defend the law, so 16 Democratic state attorneys general intervened. In December 2018, a district court declared the entire ACA to be invalid, a decision immediately appealed to the 5th U.S. Circuit Court of Appeals by the Democratic attorneys general.

The Trump administration initially agreed that the mandate was unconstitutional and should be parsed. Attorneys for the administration said, if the mandate is found unconstitutional, the court should also consider finding two other provisions – the guaranteed issue and community rating requirements – of the ACA invalid. At the time, the Trump administration said the remainder of the ACA can stand without the three linked provisions. The administration later shifted its stance and asserted that much of the ACA should fall because provisions of the law cannot be severed. However, the DOJ expressed support in keeping some provision intact, such as certain criminal statutes that prevent health care fraud.

Most recently, the DOJ has indicated that, if the ACA is struck down or severed, the decision should only apply in the 18 plaintiff states and not to the entire nation. The fickle position of the Trump administration was questioned during the Court of Appeals hearing with judges asking DOJ attorney August Flentje to clarify why a final ruling should not apply nationwide.

“A lot of this stuff would need to get sorted out,” Mr. Flentje responded. “And it’s complicated. How it applies in the states and which parts can’t be applied at all because they would injure the states ... that raises a lot of complicated issues which I think [will be determined after] a final resolution.”

By their line of questioning, the appellate panel appeared to lean toward the plaintiffs’ position more so than toward the defendants’, said Katie Keith, an attorney and health law analyst who writes about Texas v. United States for the Health Affairs Blog.

“At least two of the three judges – the only two that were asking questions – seem very inclined to at, a minimum, strike down the individual mandate itself,” Ms. Keith said in an interview. “The conventional wisdom had been that this court would overturn the lower court’s decision, and I think folks are walking away, myself included, from oral arguments feeling less certain that that’s going to happen.”

Robert Henneke, general counsel for the American Future at the Texas Public Policy Foundation, said that plaintiffs “had a good day in court” and that the defendants’ arguments seemed to “hit a thud with the judges.” Mr. Henneke represents two individual plaintiffs from Texas in the lawsuit.

“Obamacare is still unconstitutional, and the three-judge panel seemed to agree with the trial court that the entirety of the law should be struck down,” Mr. Henneke said in a press conference after oral arguments. “The court really seemed skeptical with the arguments of the other side. We had the chance to tell the story of my clients and how they continue to be hurt by the Affordable Care Act.

Whichever way the Court of Appeals rules, the losing party is expected to appeal to the U.S. Supreme Court, Ms. Keith said. If justices accept the case, a decision could arrive in the summer of 2020, which would coincide with the presidential election. Another options is for the appellate court to send the case back to the lower court for further review, particularly to clear up the DOJ’s murky position, Ms. Keith said.

“They might send it back to [the lower court] and say there’s some questions here about what’s severable,” she said. “The DOJ sort of struggled to explain what they’re talking about. So they could remand the case back to Judge [Reed Charles] O’Connor to say, ‘Figure this out. Work with the parties.’ That’s an option.”

A decision by the Court of Appeals is expected in the next two months.

[email protected]

Appellate judges appeared to doubt that the Affordable Care Act should survive without the law’s signature insurance mandate during oral arguments on July 9, in a highly watched legal battle that may upend the health care law.

During the 2-hour hearing, a three-judge panel for the 5th U.S. Circuit Court of Appeals peppered attorneys with questions about whether Congress intended the ACA to function without the individual mandate, and the panel seemed doubtful the law can stand if the regulation is parsed, according to an audio transcript of the arguments. As written, the individual mandate required that all Americans have insurance or pay a tax penalty. However, budget legislation in 2017 zeroed out the penalties associated with the mandate, rendering it unenforceable.

Appeals Judge Kurt Engelhardt, a President Trump appointee, asked defense attorney Samuel Siegel why Congress failed to add a clause in the original law that would have allowed ACA components to be severed if such sectioning was acceptable.

“Congress could have included a severability clause when it adopted the ACA in 2010. Couldn’t it have done so?” Judge Engelhardt asked during oral arguments. “It seems like it did the opposite, where it said, ‘This is a complete overhaul,’ and it set forth a bunch of factual findings. Couldn’t Congress have said, ‘Oh by the way, we think all of these provisions are such excellent ideas and helpful to the public that if any go by the wayside, then we would want the remainder to continue to apply’?”

Congress’s silence on the severing of the ACA does not create a presumption against parsing of the law, argued Mr. Siegel, who is representing the Democratic states suing to retain the ACA in Texas v. United States. He emphasized that in 2017, when Congress terminated the individual mandate penalty, it chose not to repeal preexisting protections or other important reforms instituted by the ACA.

“With that action, your Honor, Congress expressed its views that the individual marketplace and indeed the entire Affordable Care Act can operate without an enforceable individual mandate,” Mr. Siegel said. “We think that’s all this court needs to know to resolve the severability question.”

However, Appellate Judge Jennifer Elrod, a President George W. Bush appointee to the court, questioned whether legislators zeroed out the mandate penalty because they knew the law could not survive without the core provision. She surmised that Congress might have assumed, “Aha, this is the silver bullet that’s going to undo Obamacare.”

Kyle Hawkins, an attorney representing the Republican-led plaintiff states, meanwhile, argued the text of the ACA clearly declares the individual mandate essential to the law and to the goals that Congress intended to achieve.

“The Obama administration thought of that as an inseverable clause,” Mr. Hawkins argued. “The district court directly synthesized those considerations ... and it reached the correct conclusion: The individual mandate is unconstitutional and it is inseverable from the remainder of the law.”

Texas v. United States stems from a legal challenge by a group of 18 Republican state attorneys general and two individuals in 2018 who argue the ACA should be declared unconstitutional. The plaintiffs say that, because budget legislation in 2017 effectively eliminated the penalty associated with the mandate, the requirement itself is invalid. Without the mandate, the entire law must fall, the plaintiffs contend. The Department of Justice declined to fully defend the law, so 16 Democratic state attorneys general intervened. In December 2018, a district court declared the entire ACA to be invalid, a decision immediately appealed to the 5th U.S. Circuit Court of Appeals by the Democratic attorneys general.

The Trump administration initially agreed that the mandate was unconstitutional and should be parsed. Attorneys for the administration said, if the mandate is found unconstitutional, the court should also consider finding two other provisions – the guaranteed issue and community rating requirements – of the ACA invalid. At the time, the Trump administration said the remainder of the ACA can stand without the three linked provisions. The administration later shifted its stance and asserted that much of the ACA should fall because provisions of the law cannot be severed. However, the DOJ expressed support in keeping some provision intact, such as certain criminal statutes that prevent health care fraud.

Most recently, the DOJ has indicated that, if the ACA is struck down or severed, the decision should only apply in the 18 plaintiff states and not to the entire nation. The fickle position of the Trump administration was questioned during the Court of Appeals hearing with judges asking DOJ attorney August Flentje to clarify why a final ruling should not apply nationwide.

“A lot of this stuff would need to get sorted out,” Mr. Flentje responded. “And it’s complicated. How it applies in the states and which parts can’t be applied at all because they would injure the states ... that raises a lot of complicated issues which I think [will be determined after] a final resolution.”

By their line of questioning, the appellate panel appeared to lean toward the plaintiffs’ position more so than toward the defendants’, said Katie Keith, an attorney and health law analyst who writes about Texas v. United States for the Health Affairs Blog.

“At least two of the three judges – the only two that were asking questions – seem very inclined to at, a minimum, strike down the individual mandate itself,” Ms. Keith said in an interview. “The conventional wisdom had been that this court would overturn the lower court’s decision, and I think folks are walking away, myself included, from oral arguments feeling less certain that that’s going to happen.”

Robert Henneke, general counsel for the American Future at the Texas Public Policy Foundation, said that plaintiffs “had a good day in court” and that the defendants’ arguments seemed to “hit a thud with the judges.” Mr. Henneke represents two individual plaintiffs from Texas in the lawsuit.

“Obamacare is still unconstitutional, and the three-judge panel seemed to agree with the trial court that the entirety of the law should be struck down,” Mr. Henneke said in a press conference after oral arguments. “The court really seemed skeptical with the arguments of the other side. We had the chance to tell the story of my clients and how they continue to be hurt by the Affordable Care Act.

Whichever way the Court of Appeals rules, the losing party is expected to appeal to the U.S. Supreme Court, Ms. Keith said. If justices accept the case, a decision could arrive in the summer of 2020, which would coincide with the presidential election. Another options is for the appellate court to send the case back to the lower court for further review, particularly to clear up the DOJ’s murky position, Ms. Keith said.

“They might send it back to [the lower court] and say there’s some questions here about what’s severable,” she said. “The DOJ sort of struggled to explain what they’re talking about. So they could remand the case back to Judge [Reed Charles] O’Connor to say, ‘Figure this out. Work with the parties.’ That’s an option.”

A decision by the Court of Appeals is expected in the next two months.

[email protected]

Appellate judges appeared to doubt that the Affordable Care Act should survive without the law’s signature insurance mandate during oral arguments on July 9, in a highly watched legal battle that may upend the health care law.

During the 2-hour hearing, a three-judge panel for the 5th U.S. Circuit Court of Appeals peppered attorneys with questions about whether Congress intended the ACA to function without the individual mandate, and the panel seemed doubtful the law can stand if the regulation is parsed, according to an audio transcript of the arguments. As written, the individual mandate required that all Americans have insurance or pay a tax penalty. However, budget legislation in 2017 zeroed out the penalties associated with the mandate, rendering it unenforceable.

Appeals Judge Kurt Engelhardt, a President Trump appointee, asked defense attorney Samuel Siegel why Congress failed to add a clause in the original law that would have allowed ACA components to be severed if such sectioning was acceptable.

“Congress could have included a severability clause when it adopted the ACA in 2010. Couldn’t it have done so?” Judge Engelhardt asked during oral arguments. “It seems like it did the opposite, where it said, ‘This is a complete overhaul,’ and it set forth a bunch of factual findings. Couldn’t Congress have said, ‘Oh by the way, we think all of these provisions are such excellent ideas and helpful to the public that if any go by the wayside, then we would want the remainder to continue to apply’?”

Congress’s silence on the severing of the ACA does not create a presumption against parsing of the law, argued Mr. Siegel, who is representing the Democratic states suing to retain the ACA in Texas v. United States. He emphasized that in 2017, when Congress terminated the individual mandate penalty, it chose not to repeal preexisting protections or other important reforms instituted by the ACA.

“With that action, your Honor, Congress expressed its views that the individual marketplace and indeed the entire Affordable Care Act can operate without an enforceable individual mandate,” Mr. Siegel said. “We think that’s all this court needs to know to resolve the severability question.”

However, Appellate Judge Jennifer Elrod, a President George W. Bush appointee to the court, questioned whether legislators zeroed out the mandate penalty because they knew the law could not survive without the core provision. She surmised that Congress might have assumed, “Aha, this is the silver bullet that’s going to undo Obamacare.”

Kyle Hawkins, an attorney representing the Republican-led plaintiff states, meanwhile, argued the text of the ACA clearly declares the individual mandate essential to the law and to the goals that Congress intended to achieve.

“The Obama administration thought of that as an inseverable clause,” Mr. Hawkins argued. “The district court directly synthesized those considerations ... and it reached the correct conclusion: The individual mandate is unconstitutional and it is inseverable from the remainder of the law.”

Texas v. United States stems from a legal challenge by a group of 18 Republican state attorneys general and two individuals in 2018 who argue the ACA should be declared unconstitutional. The plaintiffs say that, because budget legislation in 2017 effectively eliminated the penalty associated with the mandate, the requirement itself is invalid. Without the mandate, the entire law must fall, the plaintiffs contend. The Department of Justice declined to fully defend the law, so 16 Democratic state attorneys general intervened. In December 2018, a district court declared the entire ACA to be invalid, a decision immediately appealed to the 5th U.S. Circuit Court of Appeals by the Democratic attorneys general.

The Trump administration initially agreed that the mandate was unconstitutional and should be parsed. Attorneys for the administration said, if the mandate is found unconstitutional, the court should also consider finding two other provisions – the guaranteed issue and community rating requirements – of the ACA invalid. At the time, the Trump administration said the remainder of the ACA can stand without the three linked provisions. The administration later shifted its stance and asserted that much of the ACA should fall because provisions of the law cannot be severed. However, the DOJ expressed support in keeping some provision intact, such as certain criminal statutes that prevent health care fraud.

Most recently, the DOJ has indicated that, if the ACA is struck down or severed, the decision should only apply in the 18 plaintiff states and not to the entire nation. The fickle position of the Trump administration was questioned during the Court of Appeals hearing with judges asking DOJ attorney August Flentje to clarify why a final ruling should not apply nationwide.

“A lot of this stuff would need to get sorted out,” Mr. Flentje responded. “And it’s complicated. How it applies in the states and which parts can’t be applied at all because they would injure the states ... that raises a lot of complicated issues which I think [will be determined after] a final resolution.”

By their line of questioning, the appellate panel appeared to lean toward the plaintiffs’ position more so than toward the defendants’, said Katie Keith, an attorney and health law analyst who writes about Texas v. United States for the Health Affairs Blog.

“At least two of the three judges – the only two that were asking questions – seem very inclined to at, a minimum, strike down the individual mandate itself,” Ms. Keith said in an interview. “The conventional wisdom had been that this court would overturn the lower court’s decision, and I think folks are walking away, myself included, from oral arguments feeling less certain that that’s going to happen.”

Robert Henneke, general counsel for the American Future at the Texas Public Policy Foundation, said that plaintiffs “had a good day in court” and that the defendants’ arguments seemed to “hit a thud with the judges.” Mr. Henneke represents two individual plaintiffs from Texas in the lawsuit.

“Obamacare is still unconstitutional, and the three-judge panel seemed to agree with the trial court that the entirety of the law should be struck down,” Mr. Henneke said in a press conference after oral arguments. “The court really seemed skeptical with the arguments of the other side. We had the chance to tell the story of my clients and how they continue to be hurt by the Affordable Care Act.

Whichever way the Court of Appeals rules, the losing party is expected to appeal to the U.S. Supreme Court, Ms. Keith said. If justices accept the case, a decision could arrive in the summer of 2020, which would coincide with the presidential election. Another options is for the appellate court to send the case back to the lower court for further review, particularly to clear up the DOJ’s murky position, Ms. Keith said.

“They might send it back to [the lower court] and say there’s some questions here about what’s severable,” she said. “The DOJ sort of struggled to explain what they’re talking about. So they could remand the case back to Judge [Reed Charles] O’Connor to say, ‘Figure this out. Work with the parties.’ That’s an option.”

A decision by the Court of Appeals is expected in the next two months.

[email protected]

The Department of Health & Human Services lacks the authority to require drug manufacturers to disclose the list price of drugs in television advertising, a district court judge has ruled.

©Mathier/thinkstockphotos.com

“The court finds that HHS lacks the statutory authority under the Social Security Act to adopt the [Wholesale Acquisition Cost] Disclosure Rule,” Judge Amit P. Mehta of the U.S. District Court for the District of Columbia, said in his July 8 ruling.

“Neither the [Social Security] Act’s text, structure, nor context evince an intent by Congress to empower HHS to issue a rule that compels drug manufacturers to disclose list prices. The rule is therefore invalid,” according to the ruling.

The ruling stems from a case brought against HHS by Merck & Co. Inc., Eli Lilly and Company, and Amgen Inc., along with the National Association of Advertisers Inc., in response to the May 8 final rule that required pharmaceutical manufacturers to include the wholesale acquisition cost (WAC) if above $35, in all television advertising. The final rule also required a disclaimer that if a person had health insurance that covers drugs, “your cost may be different.”

In addition to not having authority, the court took exception to the HHS issuing the rule through the Centers for Medicare & Medicaid Services.

“It has adopted a rule that regulates the conduct of market actors that are not direct participants in the Medicare or Medicaid programs,” the ruling states. “Pharmaceutical manufacturers are not health care providers, private plan carriers, or beneficiaries – each of whom plays a direct role in the public health insurance programs. They do not receive payment for their products from CMS. Their pricing decisions, of course, affect the cost of pharmaceutical benefits offered under the Medicare and Medicaid programs. But those decisions impact the program costs in an indirect way.”

The American Medical Association expressed disappointment that the final rule is not moving forward.

“The AMA supported the Trump Administration’s effort to require pricing information in direct-to-consumer television advertising of prescription drugs,” AMA President Patrice Harris, MD, said in a statement. “Last year, the AMA called for regulations requiring the ads to include the manufacturer’s list price of those drugs, and we have supported similar legislative efforts.”

Dr. Harris noted that having the list price would provide a vital piece of information when patients and their physicians are discussing treatment options, as it would “help patients have a more complete picture when faced with prescription drug ads. While current ads outline the potential benefits and side effects, a crucial factor for patients – the drug’s price – is not included. Patients, especially those who pay a drug’s list price or whose cost-sharing is based on the list price, would benefit by having another tool in their toolbox as they work with their physicians to determine their prescription drug regimens.”

Likewise, AARP also expressed disappointment in the decision, calling it “a step backward in the battle against skyrocketing drug prices and providing more information to consumers. Americans should be trusted to evaluate drug price information and discuss any concerns with their health care providers.”

Judge Mehta noted in his ruling that “the court does not question HHS’ motives in adopting the WAC Disclosure Rule. ... That policy very well could be an effective tool in halting the rising cost of prescription drugs. But no matter how vexing the problem of spiraling drug costs may be, HHS cannot do more than what Congress has authorized. The responsibility rests with Congress to act in the first instance.”

[email protected]

The Department of Health & Human Services lacks the authority to require drug manufacturers to disclose the list price of drugs in television advertising, a district court judge has ruled.

©Mathier/thinkstockphotos.com

“The court finds that HHS lacks the statutory authority under the Social Security Act to adopt the [Wholesale Acquisition Cost] Disclosure Rule,” Judge Amit P. Mehta of the U.S. District Court for the District of Columbia, said in his July 8 ruling.

“Neither the [Social Security] Act’s text, structure, nor context evince an intent by Congress to empower HHS to issue a rule that compels drug manufacturers to disclose list prices. The rule is therefore invalid,” according to the ruling.

The ruling stems from a case brought against HHS by Merck & Co. Inc., Eli Lilly and Company, and Amgen Inc., along with the National Association of Advertisers Inc., in response to the May 8 final rule that required pharmaceutical manufacturers to include the wholesale acquisition cost (WAC) if above $35, in all television advertising. The final rule also required a disclaimer that if a person had health insurance that covers drugs, “your cost may be different.”

In addition to not having authority, the court took exception to the HHS issuing the rule through the Centers for Medicare & Medicaid Services.

“It has adopted a rule that regulates the conduct of market actors that are not direct participants in the Medicare or Medicaid programs,” the ruling states. “Pharmaceutical manufacturers are not health care providers, private plan carriers, or beneficiaries – each of whom plays a direct role in the public health insurance programs. They do not receive payment for their products from CMS. Their pricing decisions, of course, affect the cost of pharmaceutical benefits offered under the Medicare and Medicaid programs. But those decisions impact the program costs in an indirect way.”

The American Medical Association expressed disappointment that the final rule is not moving forward.

“The AMA supported the Trump Administration’s effort to require pricing information in direct-to-consumer television advertising of prescription drugs,” AMA President Patrice Harris, MD, said in a statement. “Last year, the AMA called for regulations requiring the ads to include the manufacturer’s list price of those drugs, and we have supported similar legislative efforts.”

Dr. Harris noted that having the list price would provide a vital piece of information when patients and their physicians are discussing treatment options, as it would “help patients have a more complete picture when faced with prescription drug ads. While current ads outline the potential benefits and side effects, a crucial factor for patients – the drug’s price – is not included. Patients, especially those who pay a drug’s list price or whose cost-sharing is based on the list price, would benefit by having another tool in their toolbox as they work with their physicians to determine their prescription drug regimens.”

Likewise, AARP also expressed disappointment in the decision, calling it “a step backward in the battle against skyrocketing drug prices and providing more information to consumers. Americans should be trusted to evaluate drug price information and discuss any concerns with their health care providers.”

Judge Mehta noted in his ruling that “the court does not question HHS’ motives in adopting the WAC Disclosure Rule. ... That policy very well could be an effective tool in halting the rising cost of prescription drugs. But no matter how vexing the problem of spiraling drug costs may be, HHS cannot do more than what Congress has authorized. The responsibility rests with Congress to act in the first instance.”

[email protected]

The Department of Health & Human Services lacks the authority to require drug manufacturers to disclose the list price of drugs in television advertising, a district court judge has ruled.

©Mathier/thinkstockphotos.com

“The court finds that HHS lacks the statutory authority under the Social Security Act to adopt the [Wholesale Acquisition Cost] Disclosure Rule,” Judge Amit P. Mehta of the U.S. District Court for the District of Columbia, said in his July 8 ruling.

“Neither the [Social Security] Act’s text, structure, nor context evince an intent by Congress to empower HHS to issue a rule that compels drug manufacturers to disclose list prices. The rule is therefore invalid,” according to the ruling.

The ruling stems from a case brought against HHS by Merck & Co. Inc., Eli Lilly and Company, and Amgen Inc., along with the National Association of Advertisers Inc., in response to the May 8 final rule that required pharmaceutical manufacturers to include the wholesale acquisition cost (WAC) if above $35, in all television advertising. The final rule also required a disclaimer that if a person had health insurance that covers drugs, “your cost may be different.”

In addition to not having authority, the court took exception to the HHS issuing the rule through the Centers for Medicare & Medicaid Services.

“It has adopted a rule that regulates the conduct of market actors that are not direct participants in the Medicare or Medicaid programs,” the ruling states. “Pharmaceutical manufacturers are not health care providers, private plan carriers, or beneficiaries – each of whom plays a direct role in the public health insurance programs. They do not receive payment for their products from CMS. Their pricing decisions, of course, affect the cost of pharmaceutical benefits offered under the Medicare and Medicaid programs. But those decisions impact the program costs in an indirect way.”

The American Medical Association expressed disappointment that the final rule is not moving forward.

“The AMA supported the Trump Administration’s effort to require pricing information in direct-to-consumer television advertising of prescription drugs,” AMA President Patrice Harris, MD, said in a statement. “Last year, the AMA called for regulations requiring the ads to include the manufacturer’s list price of those drugs, and we have supported similar legislative efforts.”

Dr. Harris noted that having the list price would provide a vital piece of information when patients and their physicians are discussing treatment options, as it would “help patients have a more complete picture when faced with prescription drug ads. While current ads outline the potential benefits and side effects, a crucial factor for patients – the drug’s price – is not included. Patients, especially those who pay a drug’s list price or whose cost-sharing is based on the list price, would benefit by having another tool in their toolbox as they work with their physicians to determine their prescription drug regimens.”

Likewise, AARP also expressed disappointment in the decision, calling it “a step backward in the battle against skyrocketing drug prices and providing more information to consumers. Americans should be trusted to evaluate drug price information and discuss any concerns with their health care providers.”

Judge Mehta noted in his ruling that “the court does not question HHS’ motives in adopting the WAC Disclosure Rule. ... That policy very well could be an effective tool in halting the rising cost of prescription drugs. But no matter how vexing the problem of spiraling drug costs may be, HHS cannot do more than what Congress has authorized. The responsibility rests with Congress to act in the first instance.”

[email protected]

Two studies show a link between industry payments by drug manufacturers to physicians and doctors’ prescribing patterns for certain medications.

Artfoliophoto/Thinkstock

In the first study, lead author Taeho Greg Rhee, PhD, of the University of Connecticut, Farmington, and colleagues analyzed Centers for Medicare & Medicaid Services Part D data and Open Payments data for general payments from industry to physicians associated with gabapentinoids.

Specifically, investigators examined data for three brand name products: Gralise (Assertio) and Horizant (Arbor), both of which are extended release formulas approved for the treatment of seizure disorders and postherpetic neuralgia, and Lyrica (Pfizer), which is approved for treatment of seizure disorders, postherpetic neuralgia, neuropathic pain, and fibromyalgia. To evaluate prescribing patterns, researchers estimated physician prescribing as the physician’s proportion of prescription days filled for the three brand-name gabapentinoids in aggregate of all gabapentinoid prescription days filled.

Between 2014 and 2016, manufacturers of the three brand-name gabapentinoids made approximately 510,000 general payments ($11.5 million) to 51,005 physicians, according to Dr. Rhee and colleagues. The doctors represented 14% of physicians who prescribed any gabapentinoid product under Part D during the same time period.

Among physicians who prescribed any gabapentinoid, generic forms of Gralise (gabapentin; 87%) and Lyrica (pregabalin; 12%) were most frequently prescribed. However, physicians receiving payments from industry were more likely to prescribe the three brand-name gabapentinoids than they were gabapentin (JAMA Intern Med. 2019 July 8. doi: 10.1001/jamainternmed.2019.1082).

Generalist physicians received the majority of payments (62%) payments totaling about $4 million, followed by about $7 million for pain medication specialists and $1 million for other physicians.

The majority of payments were for food and beverages, gifts, or educational materials. In addition, industry payments were most commonly paid to physicians in the southern and eastern regions of the United States.

Among physicians who prescribed gabapentinoids, industry payment was associated with a higher likelihood of prescribing brand-name products than generic gabapentin and that such prescribing patterns increase Medicare spending. Data show that brand name gabapentinoids typically cost account for nearly $2,500 in mean Medicare spending per beneficiary in 2016, compared with less than $20 for a 1-month supply of gabapentin, authors noted.

In the second study, Rishad Khan, MD, of the University of Toronto and colleagues examined the association between industry payments to physicians and Medicare spending on adalimumab (Humira; AbbVie) and certolizumab (Cimzia; Union Chimique Belge), both of which are approved for Crohn’s disease and numerous other indications. Investigators analyzed CMS Part D data and Open Payments data linked to the prescribing of adalimumab and certolizumab. Payments were considered relevant if a gastroenterologist received them from a drug manufacturer the year that the medication was prescribed.

From 2014 to 2016, drug makers made more than $10 million in payments to gastroenterologists prescribing adalimumab or certolizumab, the study found. Investigators found that for every $1 in physician payments, there was a $3.16 increase in spending for adalimumab and a $4.72 increase for certolizumab (JAMA Intern Med. 2019 July 8. doi: 10.1001/jamainternmed.2019.0999).

For adalimumab, payments totaled $5.5 million for speaking and consulting, $4.9 million for food, travel,and lodging expenses, and $13,000 for education. For certolizumab, payments totaled $180,000 for speaking and consulting, $117,000 for food, travel,and lodging expenses, and $60,000 for education.

Dr. Khan and associates concluded that the findings suggest a significant association between industry payments by drug manufacturers to physicians and Medicare spending.

[email protected]

Two studies show a link between industry payments by drug manufacturers to physicians and doctors’ prescribing patterns for certain medications.

Artfoliophoto/Thinkstock

In the first study, lead author Taeho Greg Rhee, PhD, of the University of Connecticut, Farmington, and colleagues analyzed Centers for Medicare & Medicaid Services Part D data and Open Payments data for general payments from industry to physicians associated with gabapentinoids.

Specifically, investigators examined data for three brand name products: Gralise (Assertio) and Horizant (Arbor), both of which are extended release formulas approved for the treatment of seizure disorders and postherpetic neuralgia, and Lyrica (Pfizer), which is approved for treatment of seizure disorders, postherpetic neuralgia, neuropathic pain, and fibromyalgia. To evaluate prescribing patterns, researchers estimated physician prescribing as the physician’s proportion of prescription days filled for the three brand-name gabapentinoids in aggregate of all gabapentinoid prescription days filled.

Between 2014 and 2016, manufacturers of the three brand-name gabapentinoids made approximately 510,000 general payments ($11.5 million) to 51,005 physicians, according to Dr. Rhee and colleagues. The doctors represented 14% of physicians who prescribed any gabapentinoid product under Part D during the same time period.

Among physicians who prescribed any gabapentinoid, generic forms of Gralise (gabapentin; 87%) and Lyrica (pregabalin; 12%) were most frequently prescribed. However, physicians receiving payments from industry were more likely to prescribe the three brand-name gabapentinoids than they were gabapentin (JAMA Intern Med. 2019 July 8. doi: 10.1001/jamainternmed.2019.1082).

Generalist physicians received the majority of payments (62%) payments totaling about $4 million, followed by about $7 million for pain medication specialists and $1 million for other physicians.

The majority of payments were for food and beverages, gifts, or educational materials. In addition, industry payments were most commonly paid to physicians in the southern and eastern regions of the United States.

Among physicians who prescribed gabapentinoids, industry payment was associated with a higher likelihood of prescribing brand-name products than generic gabapentin and that such prescribing patterns increase Medicare spending. Data show that brand name gabapentinoids typically cost account for nearly $2,500 in mean Medicare spending per beneficiary in 2016, compared with less than $20 for a 1-month supply of gabapentin, authors noted.

In the second study, Rishad Khan, MD, of the University of Toronto and colleagues examined the association between industry payments to physicians and Medicare spending on adalimumab (Humira; AbbVie) and certolizumab (Cimzia; Union Chimique Belge), both of which are approved for Crohn’s disease and numerous other indications. Investigators analyzed CMS Part D data and Open Payments data linked to the prescribing of adalimumab and certolizumab. Payments were considered relevant if a gastroenterologist received them from a drug manufacturer the year that the medication was prescribed.

From 2014 to 2016, drug makers made more than $10 million in payments to gastroenterologists prescribing adalimumab or certolizumab, the study found. Investigators found that for every $1 in physician payments, there was a $3.16 increase in spending for adalimumab and a $4.72 increase for certolizumab (JAMA Intern Med. 2019 July 8. doi: 10.1001/jamainternmed.2019.0999).

For adalimumab, payments totaled $5.5 million for speaking and consulting, $4.9 million for food, travel,and lodging expenses, and $13,000 for education. For certolizumab, payments totaled $180,000 for speaking and consulting, $117,000 for food, travel,and lodging expenses, and $60,000 for education.

Dr. Khan and associates concluded that the findings suggest a significant association between industry payments by drug manufacturers to physicians and Medicare spending.

[email protected]

Two studies show a link between industry payments by drug manufacturers to physicians and doctors’ prescribing patterns for certain medications.

Artfoliophoto/Thinkstock

In the first study, lead author Taeho Greg Rhee, PhD, of the University of Connecticut, Farmington, and colleagues analyzed Centers for Medicare & Medicaid Services Part D data and Open Payments data for general payments from industry to physicians associated with gabapentinoids.

Specifically, investigators examined data for three brand name products: Gralise (Assertio) and Horizant (Arbor), both of which are extended release formulas approved for the treatment of seizure disorders and postherpetic neuralgia, and Lyrica (Pfizer), which is approved for treatment of seizure disorders, postherpetic neuralgia, neuropathic pain, and fibromyalgia. To evaluate prescribing patterns, researchers estimated physician prescribing as the physician’s proportion of prescription days filled for the three brand-name gabapentinoids in aggregate of all gabapentinoid prescription days filled.

Between 2014 and 2016, manufacturers of the three brand-name gabapentinoids made approximately 510,000 general payments ($11.5 million) to 51,005 physicians, according to Dr. Rhee and colleagues. The doctors represented 14% of physicians who prescribed any gabapentinoid product under Part D during the same time period.

Among physicians who prescribed any gabapentinoid, generic forms of Gralise (gabapentin; 87%) and Lyrica (pregabalin; 12%) were most frequently prescribed. However, physicians receiving payments from industry were more likely to prescribe the three brand-name gabapentinoids than they were gabapentin (JAMA Intern Med. 2019 July 8. doi: 10.1001/jamainternmed.2019.1082).

Generalist physicians received the majority of payments (62%) payments totaling about $4 million, followed by about $7 million for pain medication specialists and $1 million for other physicians.

The majority of payments were for food and beverages, gifts, or educational materials. In addition, industry payments were most commonly paid to physicians in the southern and eastern regions of the United States.

Among physicians who prescribed gabapentinoids, industry payment was associated with a higher likelihood of prescribing brand-name products than generic gabapentin and that such prescribing patterns increase Medicare spending. Data show that brand name gabapentinoids typically cost account for nearly $2,500 in mean Medicare spending per beneficiary in 2016, compared with less than $20 for a 1-month supply of gabapentin, authors noted.

In the second study, Rishad Khan, MD, of the University of Toronto and colleagues examined the association between industry payments to physicians and Medicare spending on adalimumab (Humira; AbbVie) and certolizumab (Cimzia; Union Chimique Belge), both of which are approved for Crohn’s disease and numerous other indications. Investigators analyzed CMS Part D data and Open Payments data linked to the prescribing of adalimumab and certolizumab. Payments were considered relevant if a gastroenterologist received them from a drug manufacturer the year that the medication was prescribed.

From 2014 to 2016, drug makers made more than $10 million in payments to gastroenterologists prescribing adalimumab or certolizumab, the study found. Investigators found that for every $1 in physician payments, there was a $3.16 increase in spending for adalimumab and a $4.72 increase for certolizumab (JAMA Intern Med. 2019 July 8. doi: 10.1001/jamainternmed.2019.0999).

For adalimumab, payments totaled $5.5 million for speaking and consulting, $4.9 million for food, travel,and lodging expenses, and $13,000 for education. For certolizumab, payments totaled $180,000 for speaking and consulting, $117,000 for food, travel,and lodging expenses, and $60,000 for education.

Dr. Khan and associates concluded that the findings suggest a significant association between industry payments by drug manufacturers to physicians and Medicare spending.

[email protected]

The SVS Foundation’s patient fliers project is completed, and fliers are available free to members on the SVS website. Nine vascular topics are addressed in updated fliers, including Carotid Artery Disease, Diabetes, Peripheral Arterial Disease, and more. These were redesigned to be useful in a patient waiting room, or to hand to a patient during an office visit. They are available in both English and Spanish, and can be found on the SVS website here.

The SVS Foundation’s patient fliers project is completed, and fliers are available free to members on the SVS website. Nine vascular topics are addressed in updated fliers, including Carotid Artery Disease, Diabetes, Peripheral Arterial Disease, and more. These were redesigned to be useful in a patient waiting room, or to hand to a patient during an office visit. They are available in both English and Spanish, and can be found on the SVS website here.

The SVS Foundation’s patient fliers project is completed, and fliers are available free to members on the SVS website. Nine vascular topics are addressed in updated fliers, including Carotid Artery Disease, Diabetes, Peripheral Arterial Disease, and more. These were redesigned to be useful in a patient waiting room, or to hand to a patient during an office visit. They are available in both English and Spanish, and can be found on the SVS website here.

The SVS Foundation developed the Research Career Development Travel Awards program to develop strong leaders in vascular surgery research. Recipients of the award will be assigned SVS research mentors who will provide guidance and discuss academic career advancement. They’ll also receive financial support to be used for travel, hotel accommodations and registration expenses for a research course. Applicants must be an SVS Candidate or Active Member who’s completed postgraduate clinical training in vascular surgery and has been in practice no more than seven years. Apply before August 15 to be considered.

The SVS Foundation developed the Research Career Development Travel Awards program to develop strong leaders in vascular surgery research. Recipients of the award will be assigned SVS research mentors who will provide guidance and discuss academic career advancement. They’ll also receive financial support to be used for travel, hotel accommodations and registration expenses for a research course. Applicants must be an SVS Candidate or Active Member who’s completed postgraduate clinical training in vascular surgery and has been in practice no more than seven years. Apply before August 15 to be considered.

The SVS Foundation developed the Research Career Development Travel Awards program to develop strong leaders in vascular surgery research. Recipients of the award will be assigned SVS research mentors who will provide guidance and discuss academic career advancement. They’ll also receive financial support to be used for travel, hotel accommodations and registration expenses for a research course. Applicants must be an SVS Candidate or Active Member who’s completed postgraduate clinical training in vascular surgery and has been in practice no more than seven years. Apply before August 15 to be considered.

If you attended the 2019 Vascular Annual Meeting in National Harbor, Md., be sure to check out the many photos now available on the SVS Flickr account. Relive the education sessions, the exhibit hall, the alumni receptions and the marvelous “Vascular Spectacular” gala. View, download and share these as much as you’d like. If you had your headshot taken at the SVS Booth, you can find that photo here.

If you attended the 2019 Vascular Annual Meeting in National Harbor, Md., be sure to check out the many photos now available on the SVS Flickr account. Relive the education sessions, the exhibit hall, the alumni receptions and the marvelous “Vascular Spectacular” gala. View, download and share these as much as you’d like. If you had your headshot taken at the SVS Booth, you can find that photo here.

If you attended the 2019 Vascular Annual Meeting in National Harbor, Md., be sure to check out the many photos now available on the SVS Flickr account. Relive the education sessions, the exhibit hall, the alumni receptions and the marvelous “Vascular Spectacular” gala. View, download and share these as much as you’d like. If you had your headshot taken at the SVS Booth, you can find that photo here.

Individuals with microvascular disease (MVD) showed a significantly increased risk of lower limb amputation in the absence of peripheral artery disease (PAD), according to the results of a large database analysis published online in Circulation.

memorisz/iStock/Getty Images

Furthermore, those who had both MVD and PAD had a greater than 20-fold increased risk of amputation than if they had either PAD or MVD alone, according to Joshua A. Beckman, MD, of Vanderbilt University, Nashville, Tenn., and colleagues.

“The novelty of these findings becomes clear when put into the current framework of critical limb ischemia,” they wrote.

“In a recent state of the art review of [critical limb ischemia], MVD as a whole or its components did not receive a single mention. Our work shows that MVD helps identify a population not previously considered at particularly high risk for amputation and, when added to PAD, identify a group of patients at very high risk for amputation,” they continued.

Dr. Beckman and colleagues assessed individuals in the Veterans Aging Cohort Study (VACS), a prospective longitudinal cohort of veterans. They included all VACS participants who were alive as of April 1, 2003 with the baseline as a participant’s first clinic visit on or after this date. Participants were followed from baseline to the minimum of: date of lower extremity amputation, death, or Dec. 31, 2014.

They assessed four levels of vascular involvement: neither MVD nor PAD, MVD alone, PAD alone, and MVD plus PAD, with the primary outcome being lower limb amputation, all based on a variety of measures including appropriate ICD-9 or CPT codes.

The rate of incident amputation over a median of 9.3 years of follow-up was 1.16 per 1000 person-years. At the time of amputation, retinopathy was present in 69%, nephropathy in 67%, and neuropathy in 78% of participants.

After multivariable adjustment for 216 demographic characteristics, cardiovascular disease risk factors, and other potential confounders, they found that, compared with participants without either vascular disease, the presence of MVD alone was associated with a 3.7-fold increased risk of amputation, PAD alone conferred a 13.9-fold elevated risk of amputation, and the combination of PAD and MVD was associated with a 22.7-fold increased risk of amputation.

They also found that the location of amputation also varied depending on the type of vascular disease at the time of amputation.

Participants with MVD alone accounted for 18% of all amputations, 21% of below ankle amputations, 15% of below knee amputations, and 6% of all above knee amputations. Participants with PAD alone accounted for 22% of all amputations, 17% of below ankle, 25% of below knee, and 39% of above knee amputations. The combination of MVD and PAD accounted for 45% of all amputation and caused the most amputation at all limb levels. In addition, they found a statistically significant variation in vascular involvement and level of amputation, with MVD more likely to cause a below-ankle amputation and PAD more likely to cause below- and above-knee amputations (P less than .001)

“MVD likely participates importantly in the development of adverse limb events in PAD and suggests additional patient populations who may benefit from greater foot surveillance to minimize amputation,” the researchers concluded.

The study was supported by grants from the American Heart Association. Dr. Beckman reported consulting for multiple pharmaceutical companies and serving on the DSMC for Bayer and Novartis.

[email protected]

SOURCE: Beckman JA et al. Circulation. 2019. doi: 10.1161/CIRCULATIONAHA.119.040672.

Individuals with microvascular disease (MVD) showed a significantly increased risk of lower limb amputation in the absence of peripheral artery disease (PAD), according to the results of a large database analysis published online in Circulation.

memorisz/iStock/Getty Images

Furthermore, those who had both MVD and PAD had a greater than 20-fold increased risk of amputation than if they had either PAD or MVD alone, according to Joshua A. Beckman, MD, of Vanderbilt University, Nashville, Tenn., and colleagues.

“The novelty of these findings becomes clear when put into the current framework of critical limb ischemia,” they wrote.

“In a recent state of the art review of [critical limb ischemia], MVD as a whole or its components did not receive a single mention. Our work shows that MVD helps identify a population not previously considered at particularly high risk for amputation and, when added to PAD, identify a group of patients at very high risk for amputation,” they continued.

Dr. Beckman and colleagues assessed individuals in the Veterans Aging Cohort Study (VACS), a prospective longitudinal cohort of veterans. They included all VACS participants who were alive as of April 1, 2003 with the baseline as a participant’s first clinic visit on or after this date. Participants were followed from baseline to the minimum of: date of lower extremity amputation, death, or Dec. 31, 2014.

They assessed four levels of vascular involvement: neither MVD nor PAD, MVD alone, PAD alone, and MVD plus PAD, with the primary outcome being lower limb amputation, all based on a variety of measures including appropriate ICD-9 or CPT codes.

The rate of incident amputation over a median of 9.3 years of follow-up was 1.16 per 1000 person-years. At the time of amputation, retinopathy was present in 69%, nephropathy in 67%, and neuropathy in 78% of participants.

After multivariable adjustment for 216 demographic characteristics, cardiovascular disease risk factors, and other potential confounders, they found that, compared with participants without either vascular disease, the presence of MVD alone was associated with a 3.7-fold increased risk of amputation, PAD alone conferred a 13.9-fold elevated risk of amputation, and the combination of PAD and MVD was associated with a 22.7-fold increased risk of amputation.

They also found that the location of amputation also varied depending on the type of vascular disease at the time of amputation.

Participants with MVD alone accounted for 18% of all amputations, 21% of below ankle amputations, 15% of below knee amputations, and 6% of all above knee amputations. Participants with PAD alone accounted for 22% of all amputations, 17% of below ankle, 25% of below knee, and 39% of above knee amputations. The combination of MVD and PAD accounted for 45% of all amputation and caused the most amputation at all limb levels. In addition, they found a statistically significant variation in vascular involvement and level of amputation, with MVD more likely to cause a below-ankle amputation and PAD more likely to cause below- and above-knee amputations (P less than .001)

“MVD likely participates importantly in the development of adverse limb events in PAD and suggests additional patient populations who may benefit from greater foot surveillance to minimize amputation,” the researchers concluded.

The study was supported by grants from the American Heart Association. Dr. Beckman reported consulting for multiple pharmaceutical companies and serving on the DSMC for Bayer and Novartis.

[email protected]

SOURCE: Beckman JA et al. Circulation. 2019. doi: 10.1161/CIRCULATIONAHA.119.040672.

Individuals with microvascular disease (MVD) showed a significantly increased risk of lower limb amputation in the absence of peripheral artery disease (PAD), according to the results of a large database analysis published online in Circulation.

memorisz/iStock/Getty Images

Furthermore, those who had both MVD and PAD had a greater than 20-fold increased risk of amputation than if they had either PAD or MVD alone, according to Joshua A. Beckman, MD, of Vanderbilt University, Nashville, Tenn., and colleagues.

“The novelty of these findings becomes clear when put into the current framework of critical limb ischemia,” they wrote.

“In a recent state of the art review of [critical limb ischemia], MVD as a whole or its components did not receive a single mention. Our work shows that MVD helps identify a population not previously considered at particularly high risk for amputation and, when added to PAD, identify a group of patients at very high risk for amputation,” they continued.

Dr. Beckman and colleagues assessed individuals in the Veterans Aging Cohort Study (VACS), a prospective longitudinal cohort of veterans. They included all VACS participants who were alive as of April 1, 2003 with the baseline as a participant’s first clinic visit on or after this date. Participants were followed from baseline to the minimum of: date of lower extremity amputation, death, or Dec. 31, 2014.

They assessed four levels of vascular involvement: neither MVD nor PAD, MVD alone, PAD alone, and MVD plus PAD, with the primary outcome being lower limb amputation, all based on a variety of measures including appropriate ICD-9 or CPT codes.

The rate of incident amputation over a median of 9.3 years of follow-up was 1.16 per 1000 person-years. At the time of amputation, retinopathy was present in 69%, nephropathy in 67%, and neuropathy in 78% of participants.

After multivariable adjustment for 216 demographic characteristics, cardiovascular disease risk factors, and other potential confounders, they found that, compared with participants without either vascular disease, the presence of MVD alone was associated with a 3.7-fold increased risk of amputation, PAD alone conferred a 13.9-fold elevated risk of amputation, and the combination of PAD and MVD was associated with a 22.7-fold increased risk of amputation.

They also found that the location of amputation also varied depending on the type of vascular disease at the time of amputation.

Participants with MVD alone accounted for 18% of all amputations, 21% of below ankle amputations, 15% of below knee amputations, and 6% of all above knee amputations. Participants with PAD alone accounted for 22% of all amputations, 17% of below ankle, 25% of below knee, and 39% of above knee amputations. The combination of MVD and PAD accounted for 45% of all amputation and caused the most amputation at all limb levels. In addition, they found a statistically significant variation in vascular involvement and level of amputation, with MVD more likely to cause a below-ankle amputation and PAD more likely to cause below- and above-knee amputations (P less than .001)

“MVD likely participates importantly in the development of adverse limb events in PAD and suggests additional patient populations who may benefit from greater foot surveillance to minimize amputation,” the researchers concluded.

The study was supported by grants from the American Heart Association. Dr. Beckman reported consulting for multiple pharmaceutical companies and serving on the DSMC for Bayer and Novartis.

[email protected]

SOURCE: Beckman JA et al. Circulation. 2019. doi: 10.1161/CIRCULATIONAHA.119.040672.

The Food and Drug Administration sent out one-third fewer warning letters to marketers of problematic drugs, devices, or food during the first 28 months of Donald Trump’s presidency than it did during the final 28 months of the Obama administration, according to findings from an analysis of public records sponsored by Science magazine and published July 2.

From Jan. 20, 2017, (President Trump’s inauguration day) through May 22, 2019, FDA sent out 1,033 warning letters, compared with 1,532 warning letters sent during the 28 months ending just before the inauguration, a drop of 33%, wrote Charles Piller, an investigative journalist on the Science staff (Science. 2019 Jul 2. doi: 10.1126/science.aay5859). Also during January 2017–May 2019, “official action indicated” reports, described by Mr. Piller as a frequent precursor to warning letters, fell by 45%, from 1,879 during the final 28 months of the Obama administration to 1,040 during the first 28 months of the Trump administration. The incidence of an injunction, characterized by Mr. Piller as a ”more forceful” step than a warning letter, was 35 during the 28 months before Donald Trump became president and 26 during the 28 months after, a relative 26% decline.

More detailed numbers in the report included a 33% drop in warning letters from the FDA center that deals with tobacco products, a 37% drop in warning letters from the center that deals with food safety, and a 72% fall in letters sent from the Center for Devices & Radiological Health. However the FDA Center for Drug Evaluation & Research sent 62% more warning letters (188) during the first 28 months after Donald Trump became president, compared with the final 28 months under President Obama, when it sent 116 warning letters. A year-by-year analysis that started in 2009 showed that warning letters peaked at about 800 per year during both 2011 and 2012, and then showed a steady decline during all subsequent years, falling to a rate during the first months of 2019 that projected to an annualized rate of 385 total warning letters sent by the end of this year.

In response to publication of these findings, FDA Media Relations Director Angela Stark said “the way the data are presented in the story does not accurately reflect FDA’s overarching work to protect the public health. While one publicly visible measure of FDA action, it’s important to understand that warning letters are just one action the FDA takes to seek compliance. The FDA has several tools at its disposal to work with a company to ensure compliance, such as through regulatory meetings with companies; untitled letters; follow-up inspections; and other regulatory and compliance measures depending on the situation, and we often do much of this behind the scenes in the interest of patient safety. Our use of any one enforcement tool may fluctuate year to year based on a number of factors, including the FDA’s assessment of the violations uncovered during the course of inspections, along with additional product-monitoring efforts.”

Ms. Stark also noted that, in some FDA centers, warning letters may have decreased “because the FDA has increased its interactions with industry to resolve issues, which often achieves more timely and effective corrective action.”

She also highlighted 1,300 warning letter and monetary penalty complaints sent to retailers since September 2018 over illegal sales of e-cigarettes to minors, “tens of thousands” of warning letters sent to tobacco retailers since the start of 2017 over other tobacco-related issues, and actions against stem-cell clinics that have marketed unapproved treatments.

[email protected]

SOURCE: Piller C. Science. 2019 Jul 2. doi: 10.1126/science.aay5859)

The Food and Drug Administration sent out one-third fewer warning letters to marketers of problematic drugs, devices, or food during the first 28 months of Donald Trump’s presidency than it did during the final 28 months of the Obama administration, according to findings from an analysis of public records sponsored by Science magazine and published July 2.

From Jan. 20, 2017, (President Trump’s inauguration day) through May 22, 2019, FDA sent out 1,033 warning letters, compared with 1,532 warning letters sent during the 28 months ending just before the inauguration, a drop of 33%, wrote Charles Piller, an investigative journalist on the Science staff (Science. 2019 Jul 2. doi: 10.1126/science.aay5859). Also during January 2017–May 2019, “official action indicated” reports, described by Mr. Piller as a frequent precursor to warning letters, fell by 45%, from 1,879 during the final 28 months of the Obama administration to 1,040 during the first 28 months of the Trump administration. The incidence of an injunction, characterized by Mr. Piller as a ”more forceful” step than a warning letter, was 35 during the 28 months before Donald Trump became president and 26 during the 28 months after, a relative 26% decline.

More detailed numbers in the report included a 33% drop in warning letters from the FDA center that deals with tobacco products, a 37% drop in warning letters from the center that deals with food safety, and a 72% fall in letters sent from the Center for Devices & Radiological Health. However the FDA Center for Drug Evaluation & Research sent 62% more warning letters (188) during the first 28 months after Donald Trump became president, compared with the final 28 months under President Obama, when it sent 116 warning letters. A year-by-year analysis that started in 2009 showed that warning letters peaked at about 800 per year during both 2011 and 2012, and then showed a steady decline during all subsequent years, falling to a rate during the first months of 2019 that projected to an annualized rate of 385 total warning letters sent by the end of this year.

In response to publication of these findings, FDA Media Relations Director Angela Stark said “the way the data are presented in the story does not accurately reflect FDA’s overarching work to protect the public health. While one publicly visible measure of FDA action, it’s important to understand that warning letters are just one action the FDA takes to seek compliance. The FDA has several tools at its disposal to work with a company to ensure compliance, such as through regulatory meetings with companies; untitled letters; follow-up inspections; and other regulatory and compliance measures depending on the situation, and we often do much of this behind the scenes in the interest of patient safety. Our use of any one enforcement tool may fluctuate year to year based on a number of factors, including the FDA’s assessment of the violations uncovered during the course of inspections, along with additional product-monitoring efforts.”

Ms. Stark also noted that, in some FDA centers, warning letters may have decreased “because the FDA has increased its interactions with industry to resolve issues, which often achieves more timely and effective corrective action.”

She also highlighted 1,300 warning letter and monetary penalty complaints sent to retailers since September 2018 over illegal sales of e-cigarettes to minors, “tens of thousands” of warning letters sent to tobacco retailers since the start of 2017 over other tobacco-related issues, and actions against stem-cell clinics that have marketed unapproved treatments.

[email protected]

SOURCE: Piller C. Science. 2019 Jul 2. doi: 10.1126/science.aay5859)

The Food and Drug Administration sent out one-third fewer warning letters to marketers of problematic drugs, devices, or food during the first 28 months of Donald Trump’s presidency than it did during the final 28 months of the Obama administration, according to findings from an analysis of public records sponsored by Science magazine and published July 2.

From Jan. 20, 2017, (President Trump’s inauguration day) through May 22, 2019, FDA sent out 1,033 warning letters, compared with 1,532 warning letters sent during the 28 months ending just before the inauguration, a drop of 33%, wrote Charles Piller, an investigative journalist on the Science staff (Science. 2019 Jul 2. doi: 10.1126/science.aay5859). Also during January 2017–May 2019, “official action indicated” reports, described by Mr. Piller as a frequent precursor to warning letters, fell by 45%, from 1,879 during the final 28 months of the Obama administration to 1,040 during the first 28 months of the Trump administration. The incidence of an injunction, characterized by Mr. Piller as a ”more forceful” step than a warning letter, was 35 during the 28 months before Donald Trump became president and 26 during the 28 months after, a relative 26% decline.

More detailed numbers in the report included a 33% drop in warning letters from the FDA center that deals with tobacco products, a 37% drop in warning letters from the center that deals with food safety, and a 72% fall in letters sent from the Center for Devices & Radiological Health. However the FDA Center for Drug Evaluation & Research sent 62% more warning letters (188) during the first 28 months after Donald Trump became president, compared with the final 28 months under President Obama, when it sent 116 warning letters. A year-by-year analysis that started in 2009 showed that warning letters peaked at about 800 per year during both 2011 and 2012, and then showed a steady decline during all subsequent years, falling to a rate during the first months of 2019 that projected to an annualized rate of 385 total warning letters sent by the end of this year.

In response to publication of these findings, FDA Media Relations Director Angela Stark said “the way the data are presented in the story does not accurately reflect FDA’s overarching work to protect the public health. While one publicly visible measure of FDA action, it’s important to understand that warning letters are just one action the FDA takes to seek compliance. The FDA has several tools at its disposal to work with a company to ensure compliance, such as through regulatory meetings with companies; untitled letters; follow-up inspections; and other regulatory and compliance measures depending on the situation, and we often do much of this behind the scenes in the interest of patient safety. Our use of any one enforcement tool may fluctuate year to year based on a number of factors, including the FDA’s assessment of the violations uncovered during the course of inspections, along with additional product-monitoring efforts.”

Ms. Stark also noted that, in some FDA centers, warning letters may have decreased “because the FDA has increased its interactions with industry to resolve issues, which often achieves more timely and effective corrective action.”

She also highlighted 1,300 warning letter and monetary penalty complaints sent to retailers since September 2018 over illegal sales of e-cigarettes to minors, “tens of thousands” of warning letters sent to tobacco retailers since the start of 2017 over other tobacco-related issues, and actions against stem-cell clinics that have marketed unapproved treatments.

[email protected]

SOURCE: Piller C. Science. 2019 Jul 2. doi: 10.1126/science.aay5859)

SAN DIEGO – Eat a healthy lunch. Get more sleep. Move your body. How many times in the course of a week do you give patients gentle reminders to practice these most basic steps of self-care? And how many times in the course of a week do you allow these basics to go by the wayside for yourself?

Self-care is one of the elements that can defend against physician burnout, Carol Burke, MD, said at a session on physician burnout held during the annual Digestive Disease Week^®. Personal self-care can make a real difference, and shouldn’t be ignored as the profession works to reel back some of the institutional changes that challenge physicians today.

In the workplace, unhealthy stress levels can contribute to burnout, disruptive behavior, decreased productivity, and disengagement. Burnout – a response to chronic stress characterized by a diminished sense of personal accomplishment and emotional exhaustion – can result in cynicism, a lack of compassion, and feelings of depersonalization, said Dr. Burke.

Contributors to physician stress have been well documented, said Dr. Burke, a professor of gastroenterology at the Cleveland Clinic. These range from personal debt and the struggle for work-life balance to an increased focus on metrics and documentation at the expense of authentic patient engagement. All of these factors are measurable by means of the validated Maslach Burnout Inventory, said Dr. Burke. A recent survey that used this measure indicated that nearly half of physician respondents report experiencing burnout.

In 2017, Dr. Burke led a survey of American College of Gastroenterology members that showed 49.3% of respondents reported feeling emotional exhaustion and/or depersonalization. Some key themes emerged from the survey, she said. Women and younger physicians were more likely to experience burnout. Having children in the middle years (11-15 years old) and spending more time on domestic duties and child care increased the risk of burnout.

And doing patient-related work at home or having a spouse or partner bring work home also upped burnout risk. Skipping breakfast and lunch during the workweek was another risk factor, which highlights the importance of basic self-care as armor against the administrative onslaught, said Dr. Burke.

Measured by volume alone, physician work can be overwhelming: 45% of physicians in the United States work more than 60 hours weekly, compared with fewer than 10% of the general workforce, said Dr. Burke.

What factors within the control of an individual practitioner can reduce the risk of debilitating burnout and improve quality of life? Physicians who do report a high quality of life, said Dr. Burke, are more likely to have a positive outlook. They also practice basic self-care like taking vacations, exercising regularly, and engaging in hobbies outside of work.

For exhausted, overworked clinicians, getting a good night’s sleep is a critical form of self-care. But erratic schedules, stress, and family demands can all sabotage plans for better sleep hygiene. Still, attending to sleep is important, said Dr. Burke. Individuals with disturbed sleep are less mindful and have less self-compassion. Sleep disturbance is also strongly correlated with perceived stress.

She also reported that the odds ratio for burnout was 14.7 for physicians who reported insomnia when compared with those without sleep disturbance, and it was 9.9 for those who reported nonrestorative sleep.

Physical activity can help sleep and also help other markers of burnout. Dr. Burke pointed to a recent study of 4,402 medical students. Participants were able to reduce burnout risk when they met the Centers for Disease Control and Prevention recommendations of achieving at least 150 minutes/week of moderate exercise or 75 minutes/week of vigorous exercise, plus at least 2 days/week of strength training (P less than .001; Acad Med. 2017;92:1006).

These physician-targeted programs can work, she said: “Faciliated interventions improve well-being, attitudes associated with patient-centered care, meaning and engagement in work, and reduce burnout.”

Practice-focused interventions to reclaim a semblance of control over one’s time are varied, and some are easier to implement than others. Virtual visits and group visits are surprisingly well received by patients, and each can be huge time-savers for physicians, said Dr. Burke. There are billing and workflow pitfalls to avoid, but group visits, in particular, can be practice changing for those who have heavy backlogs and see many patients with the same condition.

Medical scribes can improve productivity and reduce physician time spent on documentation. Also, said Dr. Burke, visits can appropriately be billed at a higher level of complexity when contemporaneous documentation is thorough. Clinicians overall feel that they can engage more fully with patients, and also feel more effective, when well-trained scribes are integrated into a practice, she said.

Female physicians have repeatedly been shown to have patient panels that are more demanding, and male and female patients alike expect more empathy and social support from their physicians, said Dr. Burke. When psychosocial complexities are interwoven with patient care, as they are more frequently for female providers, a 15-minute visit can easily run twice that – or more. Dr. Burke is among the physicians advocating for recognition of this invisible burden on female clinicians, either through adaptive scheduling or differential productivity expectations. This approach is not without controversy, she acknowledged; still, practices should acknowledge that clinic flow can be very different for male and female gastroenterologists, she said.

Dr. Burke reported no relevant conflicts of interest.

[email protected]

SAN DIEGO – Eat a healthy lunch. Get more sleep. Move your body. How many times in the course of a week do you give patients gentle reminders to practice these most basic steps of self-care? And how many times in the course of a week do you allow these basics to go by the wayside for yourself?

Self-care is one of the elements that can defend against physician burnout, Carol Burke, MD, said at a session on physician burnout held during the annual Digestive Disease Week^®. Personal self-care can make a real difference, and shouldn’t be ignored as the profession works to reel back some of the institutional changes that challenge physicians today.

In the workplace, unhealthy stress levels can contribute to burnout, disruptive behavior, decreased productivity, and disengagement. Burnout – a response to chronic stress characterized by a diminished sense of personal accomplishment and emotional exhaustion – can result in cynicism, a lack of compassion, and feelings of depersonalization, said Dr. Burke.

Contributors to physician stress have been well documented, said Dr. Burke, a professor of gastroenterology at the Cleveland Clinic. These range from personal debt and the struggle for work-life balance to an increased focus on metrics and documentation at the expense of authentic patient engagement. All of these factors are measurable by means of the validated Maslach Burnout Inventory, said Dr. Burke. A recent survey that used this measure indicated that nearly half of physician respondents report experiencing burnout.

In 2017, Dr. Burke led a survey of American College of Gastroenterology members that showed 49.3% of respondents reported feeling emotional exhaustion and/or depersonalization. Some key themes emerged from the survey, she said. Women and younger physicians were more likely to experience burnout. Having children in the middle years (11-15 years old) and spending more time on domestic duties and child care increased the risk of burnout.

And doing patient-related work at home or having a spouse or partner bring work home also upped burnout risk. Skipping breakfast and lunch during the workweek was another risk factor, which highlights the importance of basic self-care as armor against the administrative onslaught, said Dr. Burke.

Measured by volume alone, physician work can be overwhelming: 45% of physicians in the United States work more than 60 hours weekly, compared with fewer than 10% of the general workforce, said Dr. Burke.

What factors within the control of an individual practitioner can reduce the risk of debilitating burnout and improve quality of life? Physicians who do report a high quality of life, said Dr. Burke, are more likely to have a positive outlook. They also practice basic self-care like taking vacations, exercising regularly, and engaging in hobbies outside of work.

For exhausted, overworked clinicians, getting a good night’s sleep is a critical form of self-care. But erratic schedules, stress, and family demands can all sabotage plans for better sleep hygiene. Still, attending to sleep is important, said Dr. Burke. Individuals with disturbed sleep are less mindful and have less self-compassion. Sleep disturbance is also strongly correlated with perceived stress.

She also reported that the odds ratio for burnout was 14.7 for physicians who reported insomnia when compared with those without sleep disturbance, and it was 9.9 for those who reported nonrestorative sleep.

Physical activity can help sleep and also help other markers of burnout. Dr. Burke pointed to a recent study of 4,402 medical students. Participants were able to reduce burnout risk when they met the Centers for Disease Control and Prevention recommendations of achieving at least 150 minutes/week of moderate exercise or 75 minutes/week of vigorous exercise, plus at least 2 days/week of strength training (P less than .001; Acad Med. 2017;92:1006).

These physician-targeted programs can work, she said: “Faciliated interventions improve well-being, attitudes associated with patient-centered care, meaning and engagement in work, and reduce burnout.”

Practice-focused interventions to reclaim a semblance of control over one’s time are varied, and some are easier to implement than others. Virtual visits and group visits are surprisingly well received by patients, and each can be huge time-savers for physicians, said Dr. Burke. There are billing and workflow pitfalls to avoid, but group visits, in particular, can be practice changing for those who have heavy backlogs and see many patients with the same condition.

Medical scribes can improve productivity and reduce physician time spent on documentation. Also, said Dr. Burke, visits can appropriately be billed at a higher level of complexity when contemporaneous documentation is thorough. Clinicians overall feel that they can engage more fully with patients, and also feel more effective, when well-trained scribes are integrated into a practice, she said.

Female physicians have repeatedly been shown to have patient panels that are more demanding, and male and female patients alike expect more empathy and social support from their physicians, said Dr. Burke. When psychosocial complexities are interwoven with patient care, as they are more frequently for female providers, a 15-minute visit can easily run twice that – or more. Dr. Burke is among the physicians advocating for recognition of this invisible burden on female clinicians, either through adaptive scheduling or differential productivity expectations. This approach is not without controversy, she acknowledged; still, practices should acknowledge that clinic flow can be very different for male and female gastroenterologists, she said.

Dr. Burke reported no relevant conflicts of interest.

[email protected]

SAN DIEGO – Eat a healthy lunch. Get more sleep. Move your body. How many times in the course of a week do you give patients gentle reminders to practice these most basic steps of self-care? And how many times in the course of a week do you allow these basics to go by the wayside for yourself?

Self-care is one of the elements that can defend against physician burnout, Carol Burke, MD, said at a session on physician burnout held during the annual Digestive Disease Week^®. Personal self-care can make a real difference, and shouldn’t be ignored as the profession works to reel back some of the institutional changes that challenge physicians today.

In the workplace, unhealthy stress levels can contribute to burnout, disruptive behavior, decreased productivity, and disengagement. Burnout – a response to chronic stress characterized by a diminished sense of personal accomplishment and emotional exhaustion – can result in cynicism, a lack of compassion, and feelings of depersonalization, said Dr. Burke.

Contributors to physician stress have been well documented, said Dr. Burke, a professor of gastroenterology at the Cleveland Clinic. These range from personal debt and the struggle for work-life balance to an increased focus on metrics and documentation at the expense of authentic patient engagement. All of these factors are measurable by means of the validated Maslach Burnout Inventory, said Dr. Burke. A recent survey that used this measure indicated that nearly half of physician respondents report experiencing burnout.

In 2017, Dr. Burke led a survey of American College of Gastroenterology members that showed 49.3% of respondents reported feeling emotional exhaustion and/or depersonalization. Some key themes emerged from the survey, she said. Women and younger physicians were more likely to experience burnout. Having children in the middle years (11-15 years old) and spending more time on domestic duties and child care increased the risk of burnout.

And doing patient-related work at home or having a spouse or partner bring work home also upped burnout risk. Skipping breakfast and lunch during the workweek was another risk factor, which highlights the importance of basic self-care as armor against the administrative onslaught, said Dr. Burke.

Measured by volume alone, physician work can be overwhelming: 45% of physicians in the United States work more than 60 hours weekly, compared with fewer than 10% of the general workforce, said Dr. Burke.

What factors within the control of an individual practitioner can reduce the risk of debilitating burnout and improve quality of life? Physicians who do report a high quality of life, said Dr. Burke, are more likely to have a positive outlook. They also practice basic self-care like taking vacations, exercising regularly, and engaging in hobbies outside of work.

For exhausted, overworked clinicians, getting a good night’s sleep is a critical form of self-care. But erratic schedules, stress, and family demands can all sabotage plans for better sleep hygiene. Still, attending to sleep is important, said Dr. Burke. Individuals with disturbed sleep are less mindful and have less self-compassion. Sleep disturbance is also strongly correlated with perceived stress.

She also reported that the odds ratio for burnout was 14.7 for physicians who reported insomnia when compared with those without sleep disturbance, and it was 9.9 for those who reported nonrestorative sleep.

Physical activity can help sleep and also help other markers of burnout. Dr. Burke pointed to a recent study of 4,402 medical students. Participants were able to reduce burnout risk when they met the Centers for Disease Control and Prevention recommendations of achieving at least 150 minutes/week of moderate exercise or 75 minutes/week of vigorous exercise, plus at least 2 days/week of strength training (P less than .001; Acad Med. 2017;92:1006).

These physician-targeted programs can work, she said: “Faciliated interventions improve well-being, attitudes associated with patient-centered care, meaning and engagement in work, and reduce burnout.”

Practice-focused interventions to reclaim a semblance of control over one’s time are varied, and some are easier to implement than others. Virtual visits and group visits are surprisingly well received by patients, and each can be huge time-savers for physicians, said Dr. Burke. There are billing and workflow pitfalls to avoid, but group visits, in particular, can be practice changing for those who have heavy backlogs and see many patients with the same condition.

Medical scribes can improve productivity and reduce physician time spent on documentation. Also, said Dr. Burke, visits can appropriately be billed at a higher level of complexity when contemporaneous documentation is thorough. Clinicians overall feel that they can engage more fully with patients, and also feel more effective, when well-trained scribes are integrated into a practice, she said.

Female physicians have repeatedly been shown to have patient panels that are more demanding, and male and female patients alike expect more empathy and social support from their physicians, said Dr. Burke. When psychosocial complexities are interwoven with patient care, as they are more frequently for female providers, a 15-minute visit can easily run twice that – or more. Dr. Burke is among the physicians advocating for recognition of this invisible burden on female clinicians, either through adaptive scheduling or differential productivity expectations. This approach is not without controversy, she acknowledged; still, practices should acknowledge that clinic flow can be very different for male and female gastroenterologists, she said.

Dr. Burke reported no relevant conflicts of interest.

[email protected]

SAN FRANCISCO – Can you be “fat but fit” if you’re obese but don’t suffer from metabolic syndrome? Some advocates have claimed you can, but new findings presented at the annual scientific sessions of the American Diabetes Association provide more evidence that those extra pounds translate to extra cardiac risk.

Fat-but-fit is a misnomer, Yvonne Commodore-Mensah, PhD, RN, assistant professor at Johns Hopkins School of Nursing, Baltimore, said in an interview. “The metabolically healthy obese are not so healthy. [We found] they had a higher risk of heart disease than people who were metabolically healthy and nonobese.”

Studies began supporting the fat-but-fit “paradox” in the late 1990s. They showed “that all-cause and CVD [cardiovascular] mortality risk in obese individuals, as defined by body mass index (BMI), body fat percentage, or waist circumference, who are fit (i.e., cardiorespiratory fitness level above the age-specific and sex-specific 20th percentile) is not significantly different from their normal-weight and fit counterparts” (Br J Sports Med. 2018;52[3]:151-3).

However, a 2017 study had found that “metabolically healthy obese individuals had a higher risk of coronary heart disease, cerebrovascular disease, and heart failure [compared with] normal weight, metabolically healthy individuals” (J Am Coll Cardiol. 2017;70[12]:1429-37). And a 2016 meta-analysis of 22 studies had produced similar results but also found that metabolically healthy obese individuals were better off, cardiac-health–wise, than those of normal weight who were metabolically unhealthy (Eur J Prev Cardiol. 2016;23[9]:956-66).

Dr. Commodore-Mensah and colleagues sought to establish through their study whether there was evidence of subclinical heart disease in people who are considered obese but metabolically healthy (Abstract 272-OR).

They tracked 11,884 participants in the Atherosclerosis Risk in Communities Study (ARIC) from 1990-1992 to 2016-2018. The study, which continues today, includes participants in suburban Minneapolis; Jackson, Miss.; Forsyth County, N.C.; and Washington County, Md.

None of the participants had previous cardiovascular disease at baseline (1990-1992). The researchers divided the participants into four groups at baseline: Nonobese (with metabolic syndrome, 20% of the total number of participants; or without metabolic syndrome, 51%) and obese (with metabolic syndrome, 20%; or without metabolic syndrome, 9%).

The average age range in the groups was 56-57 years. The percentage of women in the groups ranged from 53% to 58%, except for the obese and metabolically healthy group (73%). The percentage of black participants in the groups ranged from 17% (nonobese, metabolically unhealthy) to 45% (obese, metabolically healthy).

“People who were younger, women, and black were more likely to be classified as metabolically healthy obese,” Dr. Commodore-Mensah said.

According to one adjusted model with a median follow-up of 16 years and a total of 3,560 events, obese participants had a higher risk of incident cardiovascular disease, compared with their nonobese counterparts, regardless of whether they had metabolic syndrome.

When compared with the nonobese, metabolically healthy group, the risk grew in the nonobese, metabolically unhealthy group (hazard ratio, .24; 95% confidence interval, 1.12-1.36), as well as in the obese, metabolically healthy (HR, 1.33; 95% CI, 1.15-1.53) and the obese, metabolically unhealthy (HR, 2.11; 95% CI, 1.90-2.35) groups.

The researchers also focused on the cardiac biomarker known as high-sensitive cardiac troponin T (hs-cTnT), which indicates chronic myocardial damage. “This biomarker provides us with a window to the heart,” Dr. Commodore-Mensah said.

According to previous findings reported in 2014, ARIC participants who had hs-cTnT levels of 14 ng/L or higher were much more likely than were those with undetectable levels to suffer from heart failure, death from any cause, and coronary heart disease (JACC Heart Fail. 2014;2[6]:600-7).

Based on an analysis of the hs-cTnT levels in the present study, the researchers believe obese, metabolically healthy participants fell in the intermediate range of excess subclinical myocardial damage, between the nonobese and the obese participants who are also metabolically unhealthy.

“This group is not protected from heart disease,” Dr. Commodore-Mensah said. “They should be targeted, and they would benefit from behavioral changes, such as modifying their diet and increasing physical activity levels.”

The study is funded by the National Institutes of Health. Dr. Commodore-Mensah and six coauthors reported no relevant disclosures. Two coauthors reported various disclosures.

SAN FRANCISCO – Can you be “fat but fit” if you’re obese but don’t suffer from metabolic syndrome? Some advocates have claimed you can, but new findings presented at the annual scientific sessions of the American Diabetes Association provide more evidence that those extra pounds translate to extra cardiac risk.

Fat-but-fit is a misnomer, Yvonne Commodore-Mensah, PhD, RN, assistant professor at Johns Hopkins School of Nursing, Baltimore, said in an interview. “The metabolically healthy obese are not so healthy. [We found] they had a higher risk of heart disease than people who were metabolically healthy and nonobese.”

Studies began supporting the fat-but-fit “paradox” in the late 1990s. They showed “that all-cause and CVD [cardiovascular] mortality risk in obese individuals, as defined by body mass index (BMI), body fat percentage, or waist circumference, who are fit (i.e., cardiorespiratory fitness level above the age-specific and sex-specific 20th percentile) is not significantly different from their normal-weight and fit counterparts” (Br J Sports Med. 2018;52[3]:151-3).

However, a 2017 study had found that “metabolically healthy obese individuals had a higher risk of coronary heart disease, cerebrovascular disease, and heart failure [compared with] normal weight, metabolically healthy individuals” (J Am Coll Cardiol. 2017;70[12]:1429-37). And a 2016 meta-analysis of 22 studies had produced similar results but also found that metabolically healthy obese individuals were better off, cardiac-health–wise, than those of normal weight who were metabolically unhealthy (Eur J Prev Cardiol. 2016;23[9]:956-66).

Dr. Commodore-Mensah and colleagues sought to establish through their study whether there was evidence of subclinical heart disease in people who are considered obese but metabolically healthy (Abstract 272-OR).

They tracked 11,884 participants in the Atherosclerosis Risk in Communities Study (ARIC) from 1990-1992 to 2016-2018. The study, which continues today, includes participants in suburban Minneapolis; Jackson, Miss.; Forsyth County, N.C.; and Washington County, Md.

None of the participants had previous cardiovascular disease at baseline (1990-1992). The researchers divided the participants into four groups at baseline: Nonobese (with metabolic syndrome, 20% of the total number of participants; or without metabolic syndrome, 51%) and obese (with metabolic syndrome, 20%; or without metabolic syndrome, 9%).

The average age range in the groups was 56-57 years. The percentage of women in the groups ranged from 53% to 58%, except for the obese and metabolically healthy group (73%). The percentage of black participants in the groups ranged from 17% (nonobese, metabolically unhealthy) to 45% (obese, metabolically healthy).

“People who were younger, women, and black were more likely to be classified as metabolically healthy obese,” Dr. Commodore-Mensah said.

According to one adjusted model with a median follow-up of 16 years and a total of 3,560 events, obese participants had a higher risk of incident cardiovascular disease, compared with their nonobese counterparts, regardless of whether they had metabolic syndrome.

When compared with the nonobese, metabolically healthy group, the risk grew in the nonobese, metabolically unhealthy group (hazard ratio, .24; 95% confidence interval, 1.12-1.36), as well as in the obese, metabolically healthy (HR, 1.33; 95% CI, 1.15-1.53) and the obese, metabolically unhealthy (HR, 2.11; 95% CI, 1.90-2.35) groups.

The researchers also focused on the cardiac biomarker known as high-sensitive cardiac troponin T (hs-cTnT), which indicates chronic myocardial damage. “This biomarker provides us with a window to the heart,” Dr. Commodore-Mensah said.

According to previous findings reported in 2014, ARIC participants who had hs-cTnT levels of 14 ng/L or higher were much more likely than were those with undetectable levels to suffer from heart failure, death from any cause, and coronary heart disease (JACC Heart Fail. 2014;2[6]:600-7).

Based on an analysis of the hs-cTnT levels in the present study, the researchers believe obese, metabolically healthy participants fell in the intermediate range of excess subclinical myocardial damage, between the nonobese and the obese participants who are also metabolically unhealthy.

“This group is not protected from heart disease,” Dr. Commodore-Mensah said. “They should be targeted, and they would benefit from behavioral changes, such as modifying their diet and increasing physical activity levels.”

The study is funded by the National Institutes of Health. Dr. Commodore-Mensah and six coauthors reported no relevant disclosures. Two coauthors reported various disclosures.

SAN FRANCISCO – Can you be “fat but fit” if you’re obese but don’t suffer from metabolic syndrome? Some advocates have claimed you can, but new findings presented at the annual scientific sessions of the American Diabetes Association provide more evidence that those extra pounds translate to extra cardiac risk.

Fat-but-fit is a misnomer, Yvonne Commodore-Mensah, PhD, RN, assistant professor at Johns Hopkins School of Nursing, Baltimore, said in an interview. “The metabolically healthy obese are not so healthy. [We found] they had a higher risk of heart disease than people who were metabolically healthy and nonobese.”

Studies began supporting the fat-but-fit “paradox” in the late 1990s. They showed “that all-cause and CVD [cardiovascular] mortality risk in obese individuals, as defined by body mass index (BMI), body fat percentage, or waist circumference, who are fit (i.e., cardiorespiratory fitness level above the age-specific and sex-specific 20th percentile) is not significantly different from their normal-weight and fit counterparts” (Br J Sports Med. 2018;52[3]:151-3).

However, a 2017 study had found that “metabolically healthy obese individuals had a higher risk of coronary heart disease, cerebrovascular disease, and heart failure [compared with] normal weight, metabolically healthy individuals” (J Am Coll Cardiol. 2017;70[12]:1429-37). And a 2016 meta-analysis of 22 studies had produced similar results but also found that metabolically healthy obese individuals were better off, cardiac-health–wise, than those of normal weight who were metabolically unhealthy (Eur J Prev Cardiol. 2016;23[9]:956-66).

Dr. Commodore-Mensah and colleagues sought to establish through their study whether there was evidence of subclinical heart disease in people who are considered obese but metabolically healthy (Abstract 272-OR).

They tracked 11,884 participants in the Atherosclerosis Risk in Communities Study (ARIC) from 1990-1992 to 2016-2018. The study, which continues today, includes participants in suburban Minneapolis; Jackson, Miss.; Forsyth County, N.C.; and Washington County, Md.

None of the participants had previous cardiovascular disease at baseline (1990-1992). The researchers divided the participants into four groups at baseline: Nonobese (with metabolic syndrome, 20% of the total number of participants; or without metabolic syndrome, 51%) and obese (with metabolic syndrome, 20%; or without metabolic syndrome, 9%).

The average age range in the groups was 56-57 years. The percentage of women in the groups ranged from 53% to 58%, except for the obese and metabolically healthy group (73%). The percentage of black participants in the groups ranged from 17% (nonobese, metabolically unhealthy) to 45% (obese, metabolically healthy).

“People who were younger, women, and black were more likely to be classified as metabolically healthy obese,” Dr. Commodore-Mensah said.

According to one adjusted model with a median follow-up of 16 years and a total of 3,560 events, obese participants had a higher risk of incident cardiovascular disease, compared with their nonobese counterparts, regardless of whether they had metabolic syndrome.

When compared with the nonobese, metabolically healthy group, the risk grew in the nonobese, metabolically unhealthy group (hazard ratio, .24; 95% confidence interval, 1.12-1.36), as well as in the obese, metabolically healthy (HR, 1.33; 95% CI, 1.15-1.53) and the obese, metabolically unhealthy (HR, 2.11; 95% CI, 1.90-2.35) groups.

The researchers also focused on the cardiac biomarker known as high-sensitive cardiac troponin T (hs-cTnT), which indicates chronic myocardial damage. “This biomarker provides us with a window to the heart,” Dr. Commodore-Mensah said.

According to previous findings reported in 2014, ARIC participants who had hs-cTnT levels of 14 ng/L or higher were much more likely than were those with undetectable levels to suffer from heart failure, death from any cause, and coronary heart disease (JACC Heart Fail. 2014;2[6]:600-7).

Based on an analysis of the hs-cTnT levels in the present study, the researchers believe obese, metabolically healthy participants fell in the intermediate range of excess subclinical myocardial damage, between the nonobese and the obese participants who are also metabolically unhealthy.

“This group is not protected from heart disease,” Dr. Commodore-Mensah said. “They should be targeted, and they would benefit from behavioral changes, such as modifying their diet and increasing physical activity levels.”

The study is funded by the National Institutes of Health. Dr. Commodore-Mensah and six coauthors reported no relevant disclosures. Two coauthors reported various disclosures.