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In a new statement, the American Diabetes Association (ADA) has advised against the use of compounded glucagon-like peptide 1 receptor agonist (GLP-1 RA) and dual glucose-dependent insulinotropic polypeptide (GIP)/GLP-1 RA medication classes.

The ADA recommends GLP-1 RA and GIP/GLP-1 RA medications approved by the Food and Drug Administration (FDA) for the treatment of type 2 diabetes, cardiovascular and kidney disease risk reduction, and weight management. The new ADA statement pertains to the unapproved, unregulated versions that have emerged as the demand for these medications for weight loss increases. These are often marketed directly to consumers.

“Compounded GLP-1 RA and dual GIP/GLP-1 RA products have been associated with clinically important dosing errors and adverse events. More concerning to individuals’ safety are counterfeit products that have made their way into the US drug supply chain and those advertised online and by unregulated sources,” the ADA said in the statement, published online on December 2, 2024, in Diabetes Care.

The statement, authored by Joshua J. Neumiller, PharmD, CDCES, of the Department of Pharmacotherapy, Washington State University, Spokane, and colleagues, states the following:

• Non–FDA-approved compounded incretin products are not recommended for use due to uncertainty about their content and resulting concerns about safety, quality, and effectiveness.
• If an incretin medication is unavailable (eg, in shortage), switching to a different FDA-approved medication is recommended as clinically appropriate to achieve and maintain individualized glucose-lowering, weight management, and/or cardiovascular and kidney risk reduction goals.
• Upon resolution of incretin product unavailability, reassess the appropriateness of resuming the original FDA-approved incretin medication.

The document points out that compounded products are not identical to the FDA-approved versions, may be distributed in nonstandard dosing devices, and may not provide sufficient user instructions.

However, “the ADA also recognizes that individuals and clinicians may still elect to use or recommend compounded products for financial or other reasons,” and therefore offers additional advice for the public, including the following:

• Discuss product use with their usual healthcare providers.
• Only use products that include dosing guidance.
• Verify that the compounding pharmacy is registered with FDA.

In addition, report any adverse events or medication errors to the FDA’s Medwatch.

A version of this article appeared on Medscape.com.

In a new statement, the American Diabetes Association (ADA) has advised against the use of compounded glucagon-like peptide 1 receptor agonist (GLP-1 RA) and dual glucose-dependent insulinotropic polypeptide (GIP)/GLP-1 RA medication classes.

The ADA recommends GLP-1 RA and GIP/GLP-1 RA medications approved by the Food and Drug Administration (FDA) for the treatment of type 2 diabetes, cardiovascular and kidney disease risk reduction, and weight management. The new ADA statement pertains to the unapproved, unregulated versions that have emerged as the demand for these medications for weight loss increases. These are often marketed directly to consumers.

“Compounded GLP-1 RA and dual GIP/GLP-1 RA products have been associated with clinically important dosing errors and adverse events. More concerning to individuals’ safety are counterfeit products that have made their way into the US drug supply chain and those advertised online and by unregulated sources,” the ADA said in the statement, published online on December 2, 2024, in Diabetes Care.

The statement, authored by Joshua J. Neumiller, PharmD, CDCES, of the Department of Pharmacotherapy, Washington State University, Spokane, and colleagues, states the following:

• Non–FDA-approved compounded incretin products are not recommended for use due to uncertainty about their content and resulting concerns about safety, quality, and effectiveness.
• If an incretin medication is unavailable (eg, in shortage), switching to a different FDA-approved medication is recommended as clinically appropriate to achieve and maintain individualized glucose-lowering, weight management, and/or cardiovascular and kidney risk reduction goals.
• Upon resolution of incretin product unavailability, reassess the appropriateness of resuming the original FDA-approved incretin medication.

The document points out that compounded products are not identical to the FDA-approved versions, may be distributed in nonstandard dosing devices, and may not provide sufficient user instructions.

However, “the ADA also recognizes that individuals and clinicians may still elect to use or recommend compounded products for financial or other reasons,” and therefore offers additional advice for the public, including the following:

• Discuss product use with their usual healthcare providers.
• Only use products that include dosing guidance.
• Verify that the compounding pharmacy is registered with FDA.

In addition, report any adverse events or medication errors to the FDA’s Medwatch.

A version of this article appeared on Medscape.com.

In a new statement, the American Diabetes Association (ADA) has advised against the use of compounded glucagon-like peptide 1 receptor agonist (GLP-1 RA) and dual glucose-dependent insulinotropic polypeptide (GIP)/GLP-1 RA medication classes.

The ADA recommends GLP-1 RA and GIP/GLP-1 RA medications approved by the Food and Drug Administration (FDA) for the treatment of type 2 diabetes, cardiovascular and kidney disease risk reduction, and weight management. The new ADA statement pertains to the unapproved, unregulated versions that have emerged as the demand for these medications for weight loss increases. These are often marketed directly to consumers.

“Compounded GLP-1 RA and dual GIP/GLP-1 RA products have been associated with clinically important dosing errors and adverse events. More concerning to individuals’ safety are counterfeit products that have made their way into the US drug supply chain and those advertised online and by unregulated sources,” the ADA said in the statement, published online on December 2, 2024, in Diabetes Care.

The statement, authored by Joshua J. Neumiller, PharmD, CDCES, of the Department of Pharmacotherapy, Washington State University, Spokane, and colleagues, states the following:

• Non–FDA-approved compounded incretin products are not recommended for use due to uncertainty about their content and resulting concerns about safety, quality, and effectiveness.
• If an incretin medication is unavailable (eg, in shortage), switching to a different FDA-approved medication is recommended as clinically appropriate to achieve and maintain individualized glucose-lowering, weight management, and/or cardiovascular and kidney risk reduction goals.
• Upon resolution of incretin product unavailability, reassess the appropriateness of resuming the original FDA-approved incretin medication.

The document points out that compounded products are not identical to the FDA-approved versions, may be distributed in nonstandard dosing devices, and may not provide sufficient user instructions.

However, “the ADA also recognizes that individuals and clinicians may still elect to use or recommend compounded products for financial or other reasons,” and therefore offers additional advice for the public, including the following:

• Discuss product use with their usual healthcare providers.
• Only use products that include dosing guidance.
• Verify that the compounding pharmacy is registered with FDA.

In addition, report any adverse events or medication errors to the FDA’s Medwatch.

A version of this article appeared on Medscape.com.

Even before the presidential election, the Federal Trade Commission’s (FTC) national ban on noncompete clauses faced a tough battle for survival in the courts. 

Now, legal specialists forecast a grim prognosis for the ban under Donald Trump’s return to the White House.

In April 2024, a divided FTC board approved a rule that would ban most noncompete agreements, which are the bane of many physicians in the states where they’re allowed. 

But a federal district’s court ruling put the ban on hold, and the Trump administration isn’t expected to support lifting the ban. 

“It is likely that the Trump administration will decline to defend the rule and may not even appeal the district court’s ruling, which means that the ban on noncompetes will not go into effect,” Steven Lubet, JD, a professor emeritus at Northwestern University Pritzker School of Law, Chicago, Illinois, said in an interview.

 

What’s in a Noncompete Clause?

Noncompete clauses in employee contracts typically restrict when and where workers can take future jobs. In medicine, supporters argue that the clauses are fair. Hospitals and practices provide a base of patients to physicians, they say, in return for their agreement not to go work for a competitor. 

But those opposed to these clauses argue that the restrictions harm careers and hurt patients by unfairly preventing physicians from moving to new jobs where they’re needed. 

At an April meeting, the FTC board voted 3 to 2 to ban noncompete clauses; some nonprofit organizations and senior executives were expected to be exempt. The FTC estimated that the move would save the healthcare system alone as much as $194 billion over 10 years. 

“A pandemic killed a million people in this country, and there are doctors who cannot work because of a noncompete,” declared FTC Commissioner Alvaro Bedoya. 

Hospitals protested the move. In a statement, the general counsel for the American Hospital Association called it “bad law, bad policy, and a clear sign of an agency run amok” and said the FTC ignored “mountains of contrary legal precedent and evidence about its adverse impacts on the health care markets.”

Although the American Medical Association does not support a total ban, its House of Delegates adopted policies in 2023 to support the prohibition of noncompete contracts for physicians employed by for-profit and nonprofit hospitals, hospital systems, or staffing companies. 

 

Texas Federal Judge Intervenes to Halt Ban

The ban was supposed to take effect on Sept. 4, 2024. But Texas federal judge Ada E. Brown struck down the ban in an Aug. 20 decision. She ruled that the FTC went beyond its authority.

“The district court based its ruling on a very dubious distinction between ‘unfair practices,’ which the FTC may prohibit, and ‘unfair competition,’ which, according to the court, it may not,” said Lubet. 

In fact, the ban should stand, he said. “This is a classic case of the government intervening on behalf of consumers/patients by prohibiting an unfair and harmful employment practice,” Lubet said. 

Amanda Hill, an attorney in Austin, Texas, who trains physicians about how to negotiate contracts, has a different take. “The Federal Trade Commission came down hard, and honestly, it really overstepped,” she said in an interview. “Congress needs to write laws, not regulatory bodies. I think all the lawyers went: ‘Good try, but you’re not going to get anywhere with that.’ ”

She noted that physicians themselves are divided over the value of noncompete clauses. “I would say 80% of my clients can’t stand noncompetes.” But another 20% own their own practices and hate the idea of losing their physicians to competitors, she said. 

 

Trump Isn’t Seen as Likely to Support Ban

While the Biden administration firmly supported a ban on noncompete clauses, there isn’t a strict Democratic-Republican divide over whether the agreements are a good idea. Some red states have embraced bans, and Hill said this can make sense from a Republican point of view: “We don’t want to run doctors out of town and out of the state because they think they’re going to be bound by big hospitals and corporate interests.”

In fact, former Florida congressman Matt Gaetz, a Republican briefly tapped as President-elect Trump’s nominee for attorney general, supports noncompete clauses. He filed a friend-of-the-court brief with the Texas judge that supported the FTC’s ruling, saying it is a “vindication of economic freedom and free enterprise.” 

But Republicans generally “believe that federal agencies are going too far and beyond the power granted to them by Congress,” Atlanta, Georgia, attorney Benjamin Fink, Esq., said in an interview.

And Trump is no fan of the FTC and its chair, Lina Khan, who may step down. Observers don’t expect that the Trump administration or a newly constituted FTC board will support an appeal of the Texas judge’s ruling.

“I don’t think anybody else — another agency or a private party — could step in place of the FTC if the FTC declines to defend the ban,” Atlanta attorney Neal F. Weinrich, Esq., said in an interview. In that case, “I think it ends.”

Attorneys Weinrich and Fink work at the same firm, which handles noncompete agreements for physicians. 

 

Noncompete Ban Advocates Turn to States 

Even if Kamala Harris had won the presidency, a national ban on noncompete clauses would have faced an uphill battle at the Supreme Court. 

“The Supreme Court majority has been unsympathetic to administrative agencies, interpreting their authority very narrowly,” said Lubet.

So what happens to noncompete clauses now? While bipartisan bills in Congress have tried to ban them, legislation is unlikely to pass now that Republicans will control both the House and Senate, Fink said. 

According to a recent article, 12 states prohibit noncompete clauses for physicians: Alabama, California, Colorado, Delaware, Massachusetts, Montana, New Hampshire, New Mexico, North Dakota, Oklahoma, Rhode Island, and South Dakota. 

The remaining states allow noncompetes in some form, often excluding them for employees earning below a certain threshold. For example, in Oregon, noncompete agreements may apply to employees earning more than $113,241. Most states have provisions to adjust the threshold annually. The District of Columbia permits 2-year noncompetes for “medical specialists” earning over $250,000 annually. 

Indiana employers can no longer enter into noncompete agreements with primary care providers. Other specialties may be subject to the clauses, except when the physician terminates the contract for cause or when an employer terminates the contract without cause. 

“I definitely think states are going to continue to restrict the use of noncompetes,” Fink said. 

Lubet has no disclosures. Hill, Fink, and Weinrich represent physicians in contract negotiations.

A version of this article appeared on Medscape.com.

Even before the presidential election, the Federal Trade Commission’s (FTC) national ban on noncompete clauses faced a tough battle for survival in the courts. 

Now, legal specialists forecast a grim prognosis for the ban under Donald Trump’s return to the White House.

In April 2024, a divided FTC board approved a rule that would ban most noncompete agreements, which are the bane of many physicians in the states where they’re allowed. 

But a federal district’s court ruling put the ban on hold, and the Trump administration isn’t expected to support lifting the ban. 

“It is likely that the Trump administration will decline to defend the rule and may not even appeal the district court’s ruling, which means that the ban on noncompetes will not go into effect,” Steven Lubet, JD, a professor emeritus at Northwestern University Pritzker School of Law, Chicago, Illinois, said in an interview.

 

What’s in a Noncompete Clause?

Noncompete clauses in employee contracts typically restrict when and where workers can take future jobs. In medicine, supporters argue that the clauses are fair. Hospitals and practices provide a base of patients to physicians, they say, in return for their agreement not to go work for a competitor. 

But those opposed to these clauses argue that the restrictions harm careers and hurt patients by unfairly preventing physicians from moving to new jobs where they’re needed. 

At an April meeting, the FTC board voted 3 to 2 to ban noncompete clauses; some nonprofit organizations and senior executives were expected to be exempt. The FTC estimated that the move would save the healthcare system alone as much as $194 billion over 10 years. 

“A pandemic killed a million people in this country, and there are doctors who cannot work because of a noncompete,” declared FTC Commissioner Alvaro Bedoya. 

Hospitals protested the move. In a statement, the general counsel for the American Hospital Association called it “bad law, bad policy, and a clear sign of an agency run amok” and said the FTC ignored “mountains of contrary legal precedent and evidence about its adverse impacts on the health care markets.”

Although the American Medical Association does not support a total ban, its House of Delegates adopted policies in 2023 to support the prohibition of noncompete contracts for physicians employed by for-profit and nonprofit hospitals, hospital systems, or staffing companies. 

 

Texas Federal Judge Intervenes to Halt Ban

The ban was supposed to take effect on Sept. 4, 2024. But Texas federal judge Ada E. Brown struck down the ban in an Aug. 20 decision. She ruled that the FTC went beyond its authority.

“The district court based its ruling on a very dubious distinction between ‘unfair practices,’ which the FTC may prohibit, and ‘unfair competition,’ which, according to the court, it may not,” said Lubet. 

In fact, the ban should stand, he said. “This is a classic case of the government intervening on behalf of consumers/patients by prohibiting an unfair and harmful employment practice,” Lubet said. 

Amanda Hill, an attorney in Austin, Texas, who trains physicians about how to negotiate contracts, has a different take. “The Federal Trade Commission came down hard, and honestly, it really overstepped,” she said in an interview. “Congress needs to write laws, not regulatory bodies. I think all the lawyers went: ‘Good try, but you’re not going to get anywhere with that.’ ”

She noted that physicians themselves are divided over the value of noncompete clauses. “I would say 80% of my clients can’t stand noncompetes.” But another 20% own their own practices and hate the idea of losing their physicians to competitors, she said. 

 

Trump Isn’t Seen as Likely to Support Ban

While the Biden administration firmly supported a ban on noncompete clauses, there isn’t a strict Democratic-Republican divide over whether the agreements are a good idea. Some red states have embraced bans, and Hill said this can make sense from a Republican point of view: “We don’t want to run doctors out of town and out of the state because they think they’re going to be bound by big hospitals and corporate interests.”

In fact, former Florida congressman Matt Gaetz, a Republican briefly tapped as President-elect Trump’s nominee for attorney general, supports noncompete clauses. He filed a friend-of-the-court brief with the Texas judge that supported the FTC’s ruling, saying it is a “vindication of economic freedom and free enterprise.” 

But Republicans generally “believe that federal agencies are going too far and beyond the power granted to them by Congress,” Atlanta, Georgia, attorney Benjamin Fink, Esq., said in an interview.

And Trump is no fan of the FTC and its chair, Lina Khan, who may step down. Observers don’t expect that the Trump administration or a newly constituted FTC board will support an appeal of the Texas judge’s ruling.

“I don’t think anybody else — another agency or a private party — could step in place of the FTC if the FTC declines to defend the ban,” Atlanta attorney Neal F. Weinrich, Esq., said in an interview. In that case, “I think it ends.”

Attorneys Weinrich and Fink work at the same firm, which handles noncompete agreements for physicians. 

 

Noncompete Ban Advocates Turn to States 

Even if Kamala Harris had won the presidency, a national ban on noncompete clauses would have faced an uphill battle at the Supreme Court. 

“The Supreme Court majority has been unsympathetic to administrative agencies, interpreting their authority very narrowly,” said Lubet.

So what happens to noncompete clauses now? While bipartisan bills in Congress have tried to ban them, legislation is unlikely to pass now that Republicans will control both the House and Senate, Fink said. 

According to a recent article, 12 states prohibit noncompete clauses for physicians: Alabama, California, Colorado, Delaware, Massachusetts, Montana, New Hampshire, New Mexico, North Dakota, Oklahoma, Rhode Island, and South Dakota. 

The remaining states allow noncompetes in some form, often excluding them for employees earning below a certain threshold. For example, in Oregon, noncompete agreements may apply to employees earning more than $113,241. Most states have provisions to adjust the threshold annually. The District of Columbia permits 2-year noncompetes for “medical specialists” earning over $250,000 annually. 

Indiana employers can no longer enter into noncompete agreements with primary care providers. Other specialties may be subject to the clauses, except when the physician terminates the contract for cause or when an employer terminates the contract without cause. 

“I definitely think states are going to continue to restrict the use of noncompetes,” Fink said. 

Lubet has no disclosures. Hill, Fink, and Weinrich represent physicians in contract negotiations.

A version of this article appeared on Medscape.com.

Even before the presidential election, the Federal Trade Commission’s (FTC) national ban on noncompete clauses faced a tough battle for survival in the courts. 

Now, legal specialists forecast a grim prognosis for the ban under Donald Trump’s return to the White House.

In April 2024, a divided FTC board approved a rule that would ban most noncompete agreements, which are the bane of many physicians in the states where they’re allowed. 

But a federal district’s court ruling put the ban on hold, and the Trump administration isn’t expected to support lifting the ban. 

“It is likely that the Trump administration will decline to defend the rule and may not even appeal the district court’s ruling, which means that the ban on noncompetes will not go into effect,” Steven Lubet, JD, a professor emeritus at Northwestern University Pritzker School of Law, Chicago, Illinois, said in an interview.

 

What’s in a Noncompete Clause?

Noncompete clauses in employee contracts typically restrict when and where workers can take future jobs. In medicine, supporters argue that the clauses are fair. Hospitals and practices provide a base of patients to physicians, they say, in return for their agreement not to go work for a competitor. 

But those opposed to these clauses argue that the restrictions harm careers and hurt patients by unfairly preventing physicians from moving to new jobs where they’re needed. 

At an April meeting, the FTC board voted 3 to 2 to ban noncompete clauses; some nonprofit organizations and senior executives were expected to be exempt. The FTC estimated that the move would save the healthcare system alone as much as $194 billion over 10 years. 

“A pandemic killed a million people in this country, and there are doctors who cannot work because of a noncompete,” declared FTC Commissioner Alvaro Bedoya. 

Hospitals protested the move. In a statement, the general counsel for the American Hospital Association called it “bad law, bad policy, and a clear sign of an agency run amok” and said the FTC ignored “mountains of contrary legal precedent and evidence about its adverse impacts on the health care markets.”

Although the American Medical Association does not support a total ban, its House of Delegates adopted policies in 2023 to support the prohibition of noncompete contracts for physicians employed by for-profit and nonprofit hospitals, hospital systems, or staffing companies. 

 

Texas Federal Judge Intervenes to Halt Ban

The ban was supposed to take effect on Sept. 4, 2024. But Texas federal judge Ada E. Brown struck down the ban in an Aug. 20 decision. She ruled that the FTC went beyond its authority.

“The district court based its ruling on a very dubious distinction between ‘unfair practices,’ which the FTC may prohibit, and ‘unfair competition,’ which, according to the court, it may not,” said Lubet. 

In fact, the ban should stand, he said. “This is a classic case of the government intervening on behalf of consumers/patients by prohibiting an unfair and harmful employment practice,” Lubet said. 

Amanda Hill, an attorney in Austin, Texas, who trains physicians about how to negotiate contracts, has a different take. “The Federal Trade Commission came down hard, and honestly, it really overstepped,” she said in an interview. “Congress needs to write laws, not regulatory bodies. I think all the lawyers went: ‘Good try, but you’re not going to get anywhere with that.’ ”

She noted that physicians themselves are divided over the value of noncompete clauses. “I would say 80% of my clients can’t stand noncompetes.” But another 20% own their own practices and hate the idea of losing their physicians to competitors, she said. 

 

Trump Isn’t Seen as Likely to Support Ban

While the Biden administration firmly supported a ban on noncompete clauses, there isn’t a strict Democratic-Republican divide over whether the agreements are a good idea. Some red states have embraced bans, and Hill said this can make sense from a Republican point of view: “We don’t want to run doctors out of town and out of the state because they think they’re going to be bound by big hospitals and corporate interests.”

In fact, former Florida congressman Matt Gaetz, a Republican briefly tapped as President-elect Trump’s nominee for attorney general, supports noncompete clauses. He filed a friend-of-the-court brief with the Texas judge that supported the FTC’s ruling, saying it is a “vindication of economic freedom and free enterprise.” 

But Republicans generally “believe that federal agencies are going too far and beyond the power granted to them by Congress,” Atlanta, Georgia, attorney Benjamin Fink, Esq., said in an interview.

And Trump is no fan of the FTC and its chair, Lina Khan, who may step down. Observers don’t expect that the Trump administration or a newly constituted FTC board will support an appeal of the Texas judge’s ruling.

“I don’t think anybody else — another agency or a private party — could step in place of the FTC if the FTC declines to defend the ban,” Atlanta attorney Neal F. Weinrich, Esq., said in an interview. In that case, “I think it ends.”

Attorneys Weinrich and Fink work at the same firm, which handles noncompete agreements for physicians. 

 

Noncompete Ban Advocates Turn to States 

Even if Kamala Harris had won the presidency, a national ban on noncompete clauses would have faced an uphill battle at the Supreme Court. 

“The Supreme Court majority has been unsympathetic to administrative agencies, interpreting their authority very narrowly,” said Lubet.

So what happens to noncompete clauses now? While bipartisan bills in Congress have tried to ban them, legislation is unlikely to pass now that Republicans will control both the House and Senate, Fink said. 

According to a recent article, 12 states prohibit noncompete clauses for physicians: Alabama, California, Colorado, Delaware, Massachusetts, Montana, New Hampshire, New Mexico, North Dakota, Oklahoma, Rhode Island, and South Dakota. 

The remaining states allow noncompetes in some form, often excluding them for employees earning below a certain threshold. For example, in Oregon, noncompete agreements may apply to employees earning more than $113,241. Most states have provisions to adjust the threshold annually. The District of Columbia permits 2-year noncompetes for “medical specialists” earning over $250,000 annually. 

Indiana employers can no longer enter into noncompete agreements with primary care providers. Other specialties may be subject to the clauses, except when the physician terminates the contract for cause or when an employer terminates the contract without cause. 

“I definitely think states are going to continue to restrict the use of noncompetes,” Fink said. 

Lubet has no disclosures. Hill, Fink, and Weinrich represent physicians in contract negotiations.

A version of this article appeared on Medscape.com.

Greetings from the Council of Networks. It has been two years since the Networks were restructured into seven Networks, each with several Sections. I have had the privilege of being the Chair of the Council of Networks this past year, and the engagement of the Chairs, Vice-Chairs, and steering committee members has contributed to a very successful CHEST 2024. Highlights from the meeting include the depth and breadth of 22 Experience CHEST sessions, which were held in the Exhibit Hall and gave trainees and early career faculty the opportunity to submit and present concise teaching on a topic. This year, many of these presentations were devoted to topics of diversity and inclusion.

Our program this year also honored Network Rising Stars at the Network Open Forums. These individuals were early career members who were nominated for their active engagement within CHEST and the Networks. The Networks also hosted a fun and engaging mixer, where members came together and had the opportunity to meet Network leadership, catch up with old friends, and sample a variety of Boston cuisine. I personally had the opportunity to meet several junior faculty who were excited to become involved in the Networks.

 

One of the initiatives we are working on is developing a robust mentoring program for fellows who are involved in the Networks and Sections. The pieces were put in place over the summer, and we will be gauging success of the program in the spring. 

For those of you who have yet to join a Network, we would love for you to be involved. To see the current leadership of each Network, check out their pages on chesnet.org. You can log in to your CHEST account and join as many Networks as you want.

Greetings from the Council of Networks. It has been two years since the Networks were restructured into seven Networks, each with several Sections. I have had the privilege of being the Chair of the Council of Networks this past year, and the engagement of the Chairs, Vice-Chairs, and steering committee members has contributed to a very successful CHEST 2024. Highlights from the meeting include the depth and breadth of 22 Experience CHEST sessions, which were held in the Exhibit Hall and gave trainees and early career faculty the opportunity to submit and present concise teaching on a topic. This year, many of these presentations were devoted to topics of diversity and inclusion.

Our program this year also honored Network Rising Stars at the Network Open Forums. These individuals were early career members who were nominated for their active engagement within CHEST and the Networks. The Networks also hosted a fun and engaging mixer, where members came together and had the opportunity to meet Network leadership, catch up with old friends, and sample a variety of Boston cuisine. I personally had the opportunity to meet several junior faculty who were excited to become involved in the Networks.

 

One of the initiatives we are working on is developing a robust mentoring program for fellows who are involved in the Networks and Sections. The pieces were put in place over the summer, and we will be gauging success of the program in the spring. 

For those of you who have yet to join a Network, we would love for you to be involved. To see the current leadership of each Network, check out their pages on chesnet.org. You can log in to your CHEST account and join as many Networks as you want.

Greetings from the Council of Networks. It has been two years since the Networks were restructured into seven Networks, each with several Sections. I have had the privilege of being the Chair of the Council of Networks this past year, and the engagement of the Chairs, Vice-Chairs, and steering committee members has contributed to a very successful CHEST 2024. Highlights from the meeting include the depth and breadth of 22 Experience CHEST sessions, which were held in the Exhibit Hall and gave trainees and early career faculty the opportunity to submit and present concise teaching on a topic. This year, many of these presentations were devoted to topics of diversity and inclusion.

Our program this year also honored Network Rising Stars at the Network Open Forums. These individuals were early career members who were nominated for their active engagement within CHEST and the Networks. The Networks also hosted a fun and engaging mixer, where members came together and had the opportunity to meet Network leadership, catch up with old friends, and sample a variety of Boston cuisine. I personally had the opportunity to meet several junior faculty who were excited to become involved in the Networks.

 

One of the initiatives we are working on is developing a robust mentoring program for fellows who are involved in the Networks and Sections. The pieces were put in place over the summer, and we will be gauging success of the program in the spring. 

For those of you who have yet to join a Network, we would love for you to be involved. To see the current leadership of each Network, check out their pages on chesnet.org. You can log in to your CHEST account and join as many Networks as you want.

With the year drawing to a close, it’s the perfect time to look back on the accomplishments of 2024 and discuss what we hope to see in the coming year. 

In 2023, CHEST’s philanthropic approach evolved to align with the organizational mission and elevate the value placed on giving. This was a pivotal transformation allowing CHEST to broaden its scope and deepen its impact, ensuring that every contribution continues to make a meaningful difference. 2024 was the first full year since the transition, and Bob Musacchio, PhD, CEO of CHEST, and Bob De Marco, MD, FCCP, Chair of the CHEST Board of Advisors, sat down to reflect on the year of CHEST philanthropy.

It’s been a full year since the transition to CHEST philanthropy; from your perspective, how has that transition gone so far?

Bob De Marco, MD, FCCP: It’s been a real pleasure to watch the evolution over the past year. The pillars that we defined to support our giving strategy resonated with a lot of past donors and also helped to engage new donors. Through clinical research, community impact, and dedication to education, we know exactly where our focus should be, allowing us to have the strongest impact while ensuring that donors know exactly where their gifts are going. 

Bob Musacchio, PhD: Another benefit to the redefined strategy was its clear integration with the CHEST organization. In the past year, CHEST added social responsibility as one of the organizational pillars, which clarified the commitment to both philanthropy and advocacy. By aligning every element of philanthropy with the existing CHEST mission, we are able to expand our reach exponentially. 

Let’s talk about an example of impact you’ve seen in the past year. 

De Marco: When the original CHEST Foundation merged with CHEST, we established a new priority that continues to drive our mission: bridging gaps, breaking barriers, and improving health care interactions to enhance patient outcomes and overall health. This commitment is reflected in initiatives like Bridging Specialties® and the First 5 Minutes®—both of which you can learn more about on the CHEST website. 

We’ve also entered into the second year of our partnership grant with the Association of Pulmonary and Critical Care Medicine Program Directors, which supports a fellow pursuing pulmonary and critical care medicine. This award recognizes the value of a diverse community in advancing medical education in pulmonary and critical care medicine. It provides an Accreditation Council for Graduate Medical Education fellow-in-training with the support, training, and mentorship needed to pursue a career in medical education and eventually serve as a mentor to future trainees. 

Musacchio: I’d like to highlight the growth we’ve seen in our Community Impact grants. Following the shift, the impact grants now follow a participatory grantmaking model that empowers local organizations embedded within their communities to solve problems with the unique insights and solutions that only they can provide. This new strategy includes supporting our Community Connections partners, which are highlighted during the annual meeting. In Boston for CHEST 2024, we partnered with three local organizations—Boston Health Care for the Homeless Program, We Got Us, and the Tufts Community Health Workers Engaging in Integrated Care and Community Action Programs Inter-City collaboration—as our Community Connections to financially support their causes and to highlight their work throughout our meeting. Through partnership, we can strengthen our impact and empower communities to prioritize and improve respiratory well-being, and I look forward to continuing to grow this program in Chicago for CHEST 2025. 

What’s next for CHEST philanthropy? Any closing thoughts for CHEST Physician^® readers? 

De Marco: The future is limitless for CHEST philanthropy. The more funding we receive, the more we can distribute to deserving projects. This includes expanding support to additional disease states, funding the next wave of travel grants, and giving more to support the research and clinical innovations that will shape the future of chest medicine . What I’d love to see is more CHEST members engaging with CHEST philanthropy. We invite you to connect with us—CHEST’s philanthropy team—to discuss how your continued investment can drive even greater impact or ask any questions you may have about the program. We’d welcome the opportunity to talk with you! 

Also, if you’re thinking about giving before the end of the year, please know that every gift, new or increased, will be matched dollar for dollar through December 31.

To each and every one of you: Thank you for being a part of the CHEST community—and for your generosity and dedication. 



Musacchio: I echo Dr. De Marco’s sentiment and want to reiterate that whether you’re a seasoned donor or considering your first gift, you can play a vital role in shaping the future of our field. Every gift—large or small—moves us forward and strengthens the community we all value. Thank you, and have a happy and healthy holiday season. 



MAKE A GIFT TODAY

With the year drawing to a close, it’s the perfect time to look back on the accomplishments of 2024 and discuss what we hope to see in the coming year. 

In 2023, CHEST’s philanthropic approach evolved to align with the organizational mission and elevate the value placed on giving. This was a pivotal transformation allowing CHEST to broaden its scope and deepen its impact, ensuring that every contribution continues to make a meaningful difference. 2024 was the first full year since the transition, and Bob Musacchio, PhD, CEO of CHEST, and Bob De Marco, MD, FCCP, Chair of the CHEST Board of Advisors, sat down to reflect on the year of CHEST philanthropy.

It’s been a full year since the transition to CHEST philanthropy; from your perspective, how has that transition gone so far?

Bob De Marco, MD, FCCP: It’s been a real pleasure to watch the evolution over the past year. The pillars that we defined to support our giving strategy resonated with a lot of past donors and also helped to engage new donors. Through clinical research, community impact, and dedication to education, we know exactly where our focus should be, allowing us to have the strongest impact while ensuring that donors know exactly where their gifts are going. 

Bob Musacchio, PhD: Another benefit to the redefined strategy was its clear integration with the CHEST organization. In the past year, CHEST added social responsibility as one of the organizational pillars, which clarified the commitment to both philanthropy and advocacy. By aligning every element of philanthropy with the existing CHEST mission, we are able to expand our reach exponentially. 

Let’s talk about an example of impact you’ve seen in the past year. 

De Marco: When the original CHEST Foundation merged with CHEST, we established a new priority that continues to drive our mission: bridging gaps, breaking barriers, and improving health care interactions to enhance patient outcomes and overall health. This commitment is reflected in initiatives like Bridging Specialties® and the First 5 Minutes®—both of which you can learn more about on the CHEST website. 

We’ve also entered into the second year of our partnership grant with the Association of Pulmonary and Critical Care Medicine Program Directors, which supports a fellow pursuing pulmonary and critical care medicine. This award recognizes the value of a diverse community in advancing medical education in pulmonary and critical care medicine. It provides an Accreditation Council for Graduate Medical Education fellow-in-training with the support, training, and mentorship needed to pursue a career in medical education and eventually serve as a mentor to future trainees. 

Musacchio: I’d like to highlight the growth we’ve seen in our Community Impact grants. Following the shift, the impact grants now follow a participatory grantmaking model that empowers local organizations embedded within their communities to solve problems with the unique insights and solutions that only they can provide. This new strategy includes supporting our Community Connections partners, which are highlighted during the annual meeting. In Boston for CHEST 2024, we partnered with three local organizations—Boston Health Care for the Homeless Program, We Got Us, and the Tufts Community Health Workers Engaging in Integrated Care and Community Action Programs Inter-City collaboration—as our Community Connections to financially support their causes and to highlight their work throughout our meeting. Through partnership, we can strengthen our impact and empower communities to prioritize and improve respiratory well-being, and I look forward to continuing to grow this program in Chicago for CHEST 2025. 

What’s next for CHEST philanthropy? Any closing thoughts for CHEST Physician^® readers? 

De Marco: The future is limitless for CHEST philanthropy. The more funding we receive, the more we can distribute to deserving projects. This includes expanding support to additional disease states, funding the next wave of travel grants, and giving more to support the research and clinical innovations that will shape the future of chest medicine . What I’d love to see is more CHEST members engaging with CHEST philanthropy. We invite you to connect with us—CHEST’s philanthropy team—to discuss how your continued investment can drive even greater impact or ask any questions you may have about the program. We’d welcome the opportunity to talk with you! 

Also, if you’re thinking about giving before the end of the year, please know that every gift, new or increased, will be matched dollar for dollar through December 31.

To each and every one of you: Thank you for being a part of the CHEST community—and for your generosity and dedication. 



Musacchio: I echo Dr. De Marco’s sentiment and want to reiterate that whether you’re a seasoned donor or considering your first gift, you can play a vital role in shaping the future of our field. Every gift—large or small—moves us forward and strengthens the community we all value. Thank you, and have a happy and healthy holiday season. 



MAKE A GIFT TODAY

With the year drawing to a close, it’s the perfect time to look back on the accomplishments of 2024 and discuss what we hope to see in the coming year. 

In 2023, CHEST’s philanthropic approach evolved to align with the organizational mission and elevate the value placed on giving. This was a pivotal transformation allowing CHEST to broaden its scope and deepen its impact, ensuring that every contribution continues to make a meaningful difference. 2024 was the first full year since the transition, and Bob Musacchio, PhD, CEO of CHEST, and Bob De Marco, MD, FCCP, Chair of the CHEST Board of Advisors, sat down to reflect on the year of CHEST philanthropy.

It’s been a full year since the transition to CHEST philanthropy; from your perspective, how has that transition gone so far?

Bob De Marco, MD, FCCP: It’s been a real pleasure to watch the evolution over the past year. The pillars that we defined to support our giving strategy resonated with a lot of past donors and also helped to engage new donors. Through clinical research, community impact, and dedication to education, we know exactly where our focus should be, allowing us to have the strongest impact while ensuring that donors know exactly where their gifts are going. 

Bob Musacchio, PhD: Another benefit to the redefined strategy was its clear integration with the CHEST organization. In the past year, CHEST added social responsibility as one of the organizational pillars, which clarified the commitment to both philanthropy and advocacy. By aligning every element of philanthropy with the existing CHEST mission, we are able to expand our reach exponentially. 

Let’s talk about an example of impact you’ve seen in the past year. 

De Marco: When the original CHEST Foundation merged with CHEST, we established a new priority that continues to drive our mission: bridging gaps, breaking barriers, and improving health care interactions to enhance patient outcomes and overall health. This commitment is reflected in initiatives like Bridging Specialties® and the First 5 Minutes®—both of which you can learn more about on the CHEST website. 

We’ve also entered into the second year of our partnership grant with the Association of Pulmonary and Critical Care Medicine Program Directors, which supports a fellow pursuing pulmonary and critical care medicine. This award recognizes the value of a diverse community in advancing medical education in pulmonary and critical care medicine. It provides an Accreditation Council for Graduate Medical Education fellow-in-training with the support, training, and mentorship needed to pursue a career in medical education and eventually serve as a mentor to future trainees. 

Musacchio: I’d like to highlight the growth we’ve seen in our Community Impact grants. Following the shift, the impact grants now follow a participatory grantmaking model that empowers local organizations embedded within their communities to solve problems with the unique insights and solutions that only they can provide. This new strategy includes supporting our Community Connections partners, which are highlighted during the annual meeting. In Boston for CHEST 2024, we partnered with three local organizations—Boston Health Care for the Homeless Program, We Got Us, and the Tufts Community Health Workers Engaging in Integrated Care and Community Action Programs Inter-City collaboration—as our Community Connections to financially support their causes and to highlight their work throughout our meeting. Through partnership, we can strengthen our impact and empower communities to prioritize and improve respiratory well-being, and I look forward to continuing to grow this program in Chicago for CHEST 2025. 

What’s next for CHEST philanthropy? Any closing thoughts for CHEST Physician^® readers? 

De Marco: The future is limitless for CHEST philanthropy. The more funding we receive, the more we can distribute to deserving projects. This includes expanding support to additional disease states, funding the next wave of travel grants, and giving more to support the research and clinical innovations that will shape the future of chest medicine . What I’d love to see is more CHEST members engaging with CHEST philanthropy. We invite you to connect with us—CHEST’s philanthropy team—to discuss how your continued investment can drive even greater impact or ask any questions you may have about the program. We’d welcome the opportunity to talk with you! 

Also, if you’re thinking about giving before the end of the year, please know that every gift, new or increased, will be matched dollar for dollar through December 31.

To each and every one of you: Thank you for being a part of the CHEST community—and for your generosity and dedication. 



Musacchio: I echo Dr. De Marco’s sentiment and want to reiterate that whether you’re a seasoned donor or considering your first gift, you can play a vital role in shaping the future of our field. Every gift—large or small—moves us forward and strengthens the community we all value. Thank you, and have a happy and healthy holiday season. 



MAKE A GIFT TODAY

During the month of November, CHEST displayed white ribbons around its headquarters in Glenview, Illinois, to raise awareness for lung cancer screening and early detection.

According to the World Health Organization, lung cancer kills more people yearly than breast, colon, and prostate cancers combined, and there are 2.1 million lung cancer cases worldwide. The risk of death can be drastically reduced through early detection of cancer and appropriate treatment.

“Lung Cancer Awareness Month was an opportunity for us to shine the spotlight on a disease that is impacting the lives of so many,” said Robert Musacchio, PhD, CEO of CHEST. “As a society of 22,000 respiratory professionals, we continuously provide the latest resources to our members, including the latest guidelines for lung cancer screening. Leveraging the awareness month, we wanted to spread the message throughout our local community that the best way to combat lung cancer is through early screening and detection.”

To identify and diagnose lung cancer in its earlier stages, it is recommended to seek lung cancer screening with a low-dose tomography scan (also known as low-dose CT or LDCT scan). Individuals who meet the below criteria are considered to be at high risk for developing lung cancer and should be screened:

• 50 to 80 years of age;
• have a 20 pack-year history of smoking (one pack a day for 20 years, two packs a day for 10 years, etc.); or
• currently smoke or have quit within the last 15 years.

To secure the ribbons, CHEST worked with an organization called the White Ribbon Project, which promotes awareness about lung cancer by changing public perception of the disease. Started by lung cancer survivor Heidi Onda and her husband, Pierre Onda, MD, the white ribbon initiative has spurred a movement to build community, reframe education, increase awareness, and remove the stigma against lung cancer.

“We are grateful for the advocacy and support of the American College of Chest Physicians in raising awareness for lung cancer,” Ms. Onda said. “We believe as a team of survivors, caregivers, those who have lost loved ones, advocates, the medical and science communities, industry representatives, advocacy organizations, legislators, and cancer centers that we can change the public perception of lung cancer. Anyone with lungs can get lung cancer, no one deserves it, and awareness and early detection of the disease are crucial.”

During the month of November, CHEST displayed white ribbons around its headquarters in Glenview, Illinois, to raise awareness for lung cancer screening and early detection.

According to the World Health Organization, lung cancer kills more people yearly than breast, colon, and prostate cancers combined, and there are 2.1 million lung cancer cases worldwide. The risk of death can be drastically reduced through early detection of cancer and appropriate treatment.

“Lung Cancer Awareness Month was an opportunity for us to shine the spotlight on a disease that is impacting the lives of so many,” said Robert Musacchio, PhD, CEO of CHEST. “As a society of 22,000 respiratory professionals, we continuously provide the latest resources to our members, including the latest guidelines for lung cancer screening. Leveraging the awareness month, we wanted to spread the message throughout our local community that the best way to combat lung cancer is through early screening and detection.”

To identify and diagnose lung cancer in its earlier stages, it is recommended to seek lung cancer screening with a low-dose tomography scan (also known as low-dose CT or LDCT scan). Individuals who meet the below criteria are considered to be at high risk for developing lung cancer and should be screened:

• 50 to 80 years of age;
• have a 20 pack-year history of smoking (one pack a day for 20 years, two packs a day for 10 years, etc.); or
• currently smoke or have quit within the last 15 years.

To secure the ribbons, CHEST worked with an organization called the White Ribbon Project, which promotes awareness about lung cancer by changing public perception of the disease. Started by lung cancer survivor Heidi Onda and her husband, Pierre Onda, MD, the white ribbon initiative has spurred a movement to build community, reframe education, increase awareness, and remove the stigma against lung cancer.

“We are grateful for the advocacy and support of the American College of Chest Physicians in raising awareness for lung cancer,” Ms. Onda said. “We believe as a team of survivors, caregivers, those who have lost loved ones, advocates, the medical and science communities, industry representatives, advocacy organizations, legislators, and cancer centers that we can change the public perception of lung cancer. Anyone with lungs can get lung cancer, no one deserves it, and awareness and early detection of the disease are crucial.”

During the month of November, CHEST displayed white ribbons around its headquarters in Glenview, Illinois, to raise awareness for lung cancer screening and early detection.

According to the World Health Organization, lung cancer kills more people yearly than breast, colon, and prostate cancers combined, and there are 2.1 million lung cancer cases worldwide. The risk of death can be drastically reduced through early detection of cancer and appropriate treatment.

“Lung Cancer Awareness Month was an opportunity for us to shine the spotlight on a disease that is impacting the lives of so many,” said Robert Musacchio, PhD, CEO of CHEST. “As a society of 22,000 respiratory professionals, we continuously provide the latest resources to our members, including the latest guidelines for lung cancer screening. Leveraging the awareness month, we wanted to spread the message throughout our local community that the best way to combat lung cancer is through early screening and detection.”

To identify and diagnose lung cancer in its earlier stages, it is recommended to seek lung cancer screening with a low-dose tomography scan (also known as low-dose CT or LDCT scan). Individuals who meet the below criteria are considered to be at high risk for developing lung cancer and should be screened:

• 50 to 80 years of age;
• have a 20 pack-year history of smoking (one pack a day for 20 years, two packs a day for 10 years, etc.); or
• currently smoke or have quit within the last 15 years.

To secure the ribbons, CHEST worked with an organization called the White Ribbon Project, which promotes awareness about lung cancer by changing public perception of the disease. Started by lung cancer survivor Heidi Onda and her husband, Pierre Onda, MD, the white ribbon initiative has spurred a movement to build community, reframe education, increase awareness, and remove the stigma against lung cancer.

“We are grateful for the advocacy and support of the American College of Chest Physicians in raising awareness for lung cancer,” Ms. Onda said. “We believe as a team of survivors, caregivers, those who have lost loved ones, advocates, the medical and science communities, industry representatives, advocacy organizations, legislators, and cancer centers that we can change the public perception of lung cancer. Anyone with lungs can get lung cancer, no one deserves it, and awareness and early detection of the disease are crucial.”

Starting January 1, 2025, current President-Elect, John A. Howington, MD, MBA, FCCP, will become the new President of CHEST. Dr. Howington is a general thoracic surgeon and has been involved with the CHEST organization since first attending a CHEST Annual Meeting in 1997. 

Before Dr. Howington steps into the role of President, he spoke with CHEST for a glimpse into his aspirations for 2025.



What would you like to accomplish as President of CHEST?

First, I want to express my gratitude for the honor and privilege of serving as the 87th President of CHEST. The organization is well-served by a high functioning Board of Regents and an incredible staff. My primary goal is to build on the success and momentum of the presidential years of Dr. Buckley and Dr. Addrizzo-Harris. Their annual meetings were a huge success, and the energy and enthusiasm of our members are palpable.

I feel very strongly that great things are ahead of us in the fields of pulmonary medicine and critical care. The CHEST organization will continue to focus on our mission to crush lung disease and stay true to our values of community, inclusivity, innovation, advocacy, and integrity. With 2025 marking the 90th anniversary of the college, I very much look forward to sharing the impact of the organization and showcasing what is yet to come. 

We will continue to collaborate with sister societies and like-minded industry partners to improve the quality of patient care and support clinicians in our field. Specifically, I look forward to continuing the momentum we’ve seen in early identification of lung cancer and increasing cure rates. Working as a team of interventional pulmonologists, respiratory therapists, advanced practice providers, thoracic surgeons, and more, we can make a real impact on what it means to be diagnosed with lung cancer. 



What do you consider to be CHEST’s greatest strength, and how will you build upon this during your presidency? 

CHEST’s greatest strength is the people involved with the organization. There is such a wonderful culture of inclusivity and innovation cultivated by the outstanding staff, committed volunteers, and expert faculty leaders. We have focused on continuous board development for the last eight years and are seeing the benefits in the strategic and innovative steps the Board of Regents have taken to better serve our members and patients. It’s an honor to step into the role of leading such an extraordinary group. 



What are some of the challenges facing CHEST, and how will you address them? 

While not unique to CHEST, stress and burnout remain an issue in the field of health care. Clinicians are asked to do more with limited resources to provide high-quality care to an increasing number of patients with widely varying needs. We will continue to focus on providing guidance on best practices in the field of chest medicine and sharing innovations that reduce the burdens of health care delivery. To help alleviate the stress put on clinicians, we want to do our part to help remove anything that stands between a clinician and their ability to provide the best care for patients. 



What do you ask of members to support you during your presidency? 

What I would ask of our members is that they reach out to connect. I want to both celebrate your wins in the field and work with your suggestions to improve CHEST. Making the organization stronger is a collaborative effort, and every voice matters. My email starting January 1 is president@chestnet.org, and if you need some writing inspiration, I’ve got some suggested prompts:

• Share with me a recent personal success or that of a colleague; we want to help spread the word.
• What do you find most rewarding in your practice?
• What’s a recurring challenge you face in practice?
• What is CHEST getting right? Where can we improve?

I look forward to hearing from you.

Warmest regards, 

John A. Howington, MD, MBA, FCCP

Starting January 1, 2025, current President-Elect, John A. Howington, MD, MBA, FCCP, will become the new President of CHEST. Dr. Howington is a general thoracic surgeon and has been involved with the CHEST organization since first attending a CHEST Annual Meeting in 1997. 

Before Dr. Howington steps into the role of President, he spoke with CHEST for a glimpse into his aspirations for 2025.



What would you like to accomplish as President of CHEST?

First, I want to express my gratitude for the honor and privilege of serving as the 87th President of CHEST. The organization is well-served by a high functioning Board of Regents and an incredible staff. My primary goal is to build on the success and momentum of the presidential years of Dr. Buckley and Dr. Addrizzo-Harris. Their annual meetings were a huge success, and the energy and enthusiasm of our members are palpable.

I feel very strongly that great things are ahead of us in the fields of pulmonary medicine and critical care. The CHEST organization will continue to focus on our mission to crush lung disease and stay true to our values of community, inclusivity, innovation, advocacy, and integrity. With 2025 marking the 90th anniversary of the college, I very much look forward to sharing the impact of the organization and showcasing what is yet to come. 

We will continue to collaborate with sister societies and like-minded industry partners to improve the quality of patient care and support clinicians in our field. Specifically, I look forward to continuing the momentum we’ve seen in early identification of lung cancer and increasing cure rates. Working as a team of interventional pulmonologists, respiratory therapists, advanced practice providers, thoracic surgeons, and more, we can make a real impact on what it means to be diagnosed with lung cancer. 



What do you consider to be CHEST’s greatest strength, and how will you build upon this during your presidency? 

CHEST’s greatest strength is the people involved with the organization. There is such a wonderful culture of inclusivity and innovation cultivated by the outstanding staff, committed volunteers, and expert faculty leaders. We have focused on continuous board development for the last eight years and are seeing the benefits in the strategic and innovative steps the Board of Regents have taken to better serve our members and patients. It’s an honor to step into the role of leading such an extraordinary group. 



What are some of the challenges facing CHEST, and how will you address them? 

While not unique to CHEST, stress and burnout remain an issue in the field of health care. Clinicians are asked to do more with limited resources to provide high-quality care to an increasing number of patients with widely varying needs. We will continue to focus on providing guidance on best practices in the field of chest medicine and sharing innovations that reduce the burdens of health care delivery. To help alleviate the stress put on clinicians, we want to do our part to help remove anything that stands between a clinician and their ability to provide the best care for patients. 



What do you ask of members to support you during your presidency? 

What I would ask of our members is that they reach out to connect. I want to both celebrate your wins in the field and work with your suggestions to improve CHEST. Making the organization stronger is a collaborative effort, and every voice matters. My email starting January 1 is president@chestnet.org, and if you need some writing inspiration, I’ve got some suggested prompts:

• Share with me a recent personal success or that of a colleague; we want to help spread the word.
• What do you find most rewarding in your practice?
• What’s a recurring challenge you face in practice?
• What is CHEST getting right? Where can we improve?

I look forward to hearing from you.

Warmest regards, 

John A. Howington, MD, MBA, FCCP

Starting January 1, 2025, current President-Elect, John A. Howington, MD, MBA, FCCP, will become the new President of CHEST. Dr. Howington is a general thoracic surgeon and has been involved with the CHEST organization since first attending a CHEST Annual Meeting in 1997. 

Before Dr. Howington steps into the role of President, he spoke with CHEST for a glimpse into his aspirations for 2025.



What would you like to accomplish as President of CHEST?

First, I want to express my gratitude for the honor and privilege of serving as the 87th President of CHEST. The organization is well-served by a high functioning Board of Regents and an incredible staff. My primary goal is to build on the success and momentum of the presidential years of Dr. Buckley and Dr. Addrizzo-Harris. Their annual meetings were a huge success, and the energy and enthusiasm of our members are palpable.

I feel very strongly that great things are ahead of us in the fields of pulmonary medicine and critical care. The CHEST organization will continue to focus on our mission to crush lung disease and stay true to our values of community, inclusivity, innovation, advocacy, and integrity. With 2025 marking the 90th anniversary of the college, I very much look forward to sharing the impact of the organization and showcasing what is yet to come. 

We will continue to collaborate with sister societies and like-minded industry partners to improve the quality of patient care and support clinicians in our field. Specifically, I look forward to continuing the momentum we’ve seen in early identification of lung cancer and increasing cure rates. Working as a team of interventional pulmonologists, respiratory therapists, advanced practice providers, thoracic surgeons, and more, we can make a real impact on what it means to be diagnosed with lung cancer. 



What do you consider to be CHEST’s greatest strength, and how will you build upon this during your presidency? 

CHEST’s greatest strength is the people involved with the organization. There is such a wonderful culture of inclusivity and innovation cultivated by the outstanding staff, committed volunteers, and expert faculty leaders. We have focused on continuous board development for the last eight years and are seeing the benefits in the strategic and innovative steps the Board of Regents have taken to better serve our members and patients. It’s an honor to step into the role of leading such an extraordinary group. 



What are some of the challenges facing CHEST, and how will you address them? 

While not unique to CHEST, stress and burnout remain an issue in the field of health care. Clinicians are asked to do more with limited resources to provide high-quality care to an increasing number of patients with widely varying needs. We will continue to focus on providing guidance on best practices in the field of chest medicine and sharing innovations that reduce the burdens of health care delivery. To help alleviate the stress put on clinicians, we want to do our part to help remove anything that stands between a clinician and their ability to provide the best care for patients. 



What do you ask of members to support you during your presidency? 

What I would ask of our members is that they reach out to connect. I want to both celebrate your wins in the field and work with your suggestions to improve CHEST. Making the organization stronger is a collaborative effort, and every voice matters. My email starting January 1 is president@chestnet.org, and if you need some writing inspiration, I’ve got some suggested prompts:

• Share with me a recent personal success or that of a colleague; we want to help spread the word.
• What do you find most rewarding in your practice?
• What’s a recurring challenge you face in practice?
• What is CHEST getting right? Where can we improve?

I look forward to hearing from you.

Warmest regards, 

John A. Howington, MD, MBA, FCCP

In the high-stakes environment of the intensive care unit (ICU), red blood cell (RBC) transfusions are a common intervention. With approximately 25% of critically ill patients in the US receiving RBC transfusions, optimizing the approach to transfusion is vital not only for patient safety but also for resource management. A recent guideline from CHEST emphasizes the importance of a restrictive RBC transfusion approach in critically ill adults, aligning with growing evidence that restrictive transfusion thresholds do not compromise survival or recovery and may reduce adverse events in many cases. For the bedside clinician and health care systems, this presents both an opportunity and a challenge: to recalibrate transfusion practices while maintaining the highest standards of patient care.

Why a restrictive strategy?

Historically, transfusions were administered to optimize oxygen delivery to organs in the presence of anemia. However, studies have highlighted the risks associated with transfusions, such as transfusion-related lung injury, circulatory overload, and increased nosocomial infections. These risks are particularly pronounced in critically ill patients, who are often more vulnerable to complications from any additional physiological burden.

The restrictive approach—typically recommended at a hemoglobin threshold of 7 to 8 g/dL—has been shown to be the safer alternative for most ICU patients, as highlighted in recently published clinical guidelines. The data supporting this approach suggest that a restrictive transfusion strategy not only spares patients unnecessary transfusions but also aligns with cost-effective and resource-efficient health care practices.

Key recommendations

For ICU providers, this guideline presents specific recommendations based on a patient’s condition:

• General critical illness: The restrictive approach is preferred over a permissive one, with no adverse effect on ICU mortality, one-year survival, or adverse events. In other words, lower Hgb thresholds do not correlate with poorer outcomes in most critically ill patients.

• Acute gastrointestinal bleeding: Evidence favors a restrictive approach, associated with reduced rebleeding risk and short-term mortality. Studies show a significantly lower incidence of transfusion reactions and costs without compromising patient safety.

• Acute coronary syndrome (ACS): A more cautious approach is advised here. In cases of ACS, a restrictive RBC transfusion strategy could potentially increase the risk of cardiac death. It is recommended to avoid a restrictive approach, as it remains unclear whether there is a gradient effect—where risk progressively increases below a hemoglobin level of 10 g/dL—or a threshold effect at 10 g/dL. In other words, the data does not clarify if a hemoglobin level of 9 g/dL is as safe as 10 g/dL. An individualized transfusion approach, considering patient symptoms and other physiological markers, is recommended.

• Post-cardiac surgery: For postoperative patients, a restrictive strategy is suggested, as it conserves RBCs without impacting outcomes such as mortality or length of hospital stay.

• Isolated troponin elevation: In cases of elevated troponin without evidence of cardiac ischemia, transfusion decisions should consider additional patient-specific variables, with a restrictive approach as the baseline.

• Septic shock: RBC transfusions as part of a resuscitation bundle were not analyzed, as isolating the impact of RBC transfusions from other bundle elements was not feasible. However, with no clear benefit and similar adverse effects, neither strategy proved clinically superior. Nonetheless, a restrictive approach conserves RBC units, thereby saving resources and reducing costs.

The economics of restriction

Beyond clinical benefits, a restrictive approach conserves precious health care resources. With the cost of a single RBC unit hovering around $200—and significantly higher once administrative and logistic expenses are accounted for—reducing unnecessary transfusions translates into substantial savings. For a health care system already strained by limited blood supply and rising demand, a 40% reduction in transfusions across ICUs could alleviate supply pressures and contribute to more equitable resource distribution.

Easier said than done

Adopting a restrictive transfusion policy is not without challenges. Clinicians are trained to act decisively in critical situations, and, often, the instinct is to do more rather than less. However, studies indicate that with proper education, awareness, and decision-support systems, a restrictive policy is both feasible and effective. Institutions may consider behavior modification strategies, such as standardized transfusion order sets and decision-support tools within electronic medical records, to aid in adjusting transfusion practices.

Call to action

The message is clear: For most critically ill patients, a restrictive RBC transfusion strategy is not only safe but optimal. For ICU teams, this calls for a proactive shift in approach. It is a call to scrutinize transfusion triggers and lean toward a judicious, evidence-based approach.

While cases like ACS may require a different approach, the evidence strongly supports that, under most circumstances, less is more. Embracing this approach requires careful consideration, yet the potential benefits for patient safety and health care sustainability are compelling.

As critical care professionals, let us lead the way in refining transfusion practices to uphold patient safety, optimize resources, and adapt to evidence-based guidelines.



ACCESS THE FULL GUIDELINE

In the high-stakes environment of the intensive care unit (ICU), red blood cell (RBC) transfusions are a common intervention. With approximately 25% of critically ill patients in the US receiving RBC transfusions, optimizing the approach to transfusion is vital not only for patient safety but also for resource management. A recent guideline from CHEST emphasizes the importance of a restrictive RBC transfusion approach in critically ill adults, aligning with growing evidence that restrictive transfusion thresholds do not compromise survival or recovery and may reduce adverse events in many cases. For the bedside clinician and health care systems, this presents both an opportunity and a challenge: to recalibrate transfusion practices while maintaining the highest standards of patient care.

Why a restrictive strategy?

Historically, transfusions were administered to optimize oxygen delivery to organs in the presence of anemia. However, studies have highlighted the risks associated with transfusions, such as transfusion-related lung injury, circulatory overload, and increased nosocomial infections. These risks are particularly pronounced in critically ill patients, who are often more vulnerable to complications from any additional physiological burden.

The restrictive approach—typically recommended at a hemoglobin threshold of 7 to 8 g/dL—has been shown to be the safer alternative for most ICU patients, as highlighted in recently published clinical guidelines. The data supporting this approach suggest that a restrictive transfusion strategy not only spares patients unnecessary transfusions but also aligns with cost-effective and resource-efficient health care practices.

Key recommendations

For ICU providers, this guideline presents specific recommendations based on a patient’s condition:

• General critical illness: The restrictive approach is preferred over a permissive one, with no adverse effect on ICU mortality, one-year survival, or adverse events. In other words, lower Hgb thresholds do not correlate with poorer outcomes in most critically ill patients.

• Acute gastrointestinal bleeding: Evidence favors a restrictive approach, associated with reduced rebleeding risk and short-term mortality. Studies show a significantly lower incidence of transfusion reactions and costs without compromising patient safety.

• Acute coronary syndrome (ACS): A more cautious approach is advised here. In cases of ACS, a restrictive RBC transfusion strategy could potentially increase the risk of cardiac death. It is recommended to avoid a restrictive approach, as it remains unclear whether there is a gradient effect—where risk progressively increases below a hemoglobin level of 10 g/dL—or a threshold effect at 10 g/dL. In other words, the data does not clarify if a hemoglobin level of 9 g/dL is as safe as 10 g/dL. An individualized transfusion approach, considering patient symptoms and other physiological markers, is recommended.

• Post-cardiac surgery: For postoperative patients, a restrictive strategy is suggested, as it conserves RBCs without impacting outcomes such as mortality or length of hospital stay.

• Isolated troponin elevation: In cases of elevated troponin without evidence of cardiac ischemia, transfusion decisions should consider additional patient-specific variables, with a restrictive approach as the baseline.

• Septic shock: RBC transfusions as part of a resuscitation bundle were not analyzed, as isolating the impact of RBC transfusions from other bundle elements was not feasible. However, with no clear benefit and similar adverse effects, neither strategy proved clinically superior. Nonetheless, a restrictive approach conserves RBC units, thereby saving resources and reducing costs.

The economics of restriction

Beyond clinical benefits, a restrictive approach conserves precious health care resources. With the cost of a single RBC unit hovering around $200—and significantly higher once administrative and logistic expenses are accounted for—reducing unnecessary transfusions translates into substantial savings. For a health care system already strained by limited blood supply and rising demand, a 40% reduction in transfusions across ICUs could alleviate supply pressures and contribute to more equitable resource distribution.

Easier said than done

Adopting a restrictive transfusion policy is not without challenges. Clinicians are trained to act decisively in critical situations, and, often, the instinct is to do more rather than less. However, studies indicate that with proper education, awareness, and decision-support systems, a restrictive policy is both feasible and effective. Institutions may consider behavior modification strategies, such as standardized transfusion order sets and decision-support tools within electronic medical records, to aid in adjusting transfusion practices.

Call to action

The message is clear: For most critically ill patients, a restrictive RBC transfusion strategy is not only safe but optimal. For ICU teams, this calls for a proactive shift in approach. It is a call to scrutinize transfusion triggers and lean toward a judicious, evidence-based approach.

While cases like ACS may require a different approach, the evidence strongly supports that, under most circumstances, less is more. Embracing this approach requires careful consideration, yet the potential benefits for patient safety and health care sustainability are compelling.

As critical care professionals, let us lead the way in refining transfusion practices to uphold patient safety, optimize resources, and adapt to evidence-based guidelines.



ACCESS THE FULL GUIDELINE

In the high-stakes environment of the intensive care unit (ICU), red blood cell (RBC) transfusions are a common intervention. With approximately 25% of critically ill patients in the US receiving RBC transfusions, optimizing the approach to transfusion is vital not only for patient safety but also for resource management. A recent guideline from CHEST emphasizes the importance of a restrictive RBC transfusion approach in critically ill adults, aligning with growing evidence that restrictive transfusion thresholds do not compromise survival or recovery and may reduce adverse events in many cases. For the bedside clinician and health care systems, this presents both an opportunity and a challenge: to recalibrate transfusion practices while maintaining the highest standards of patient care.

Why a restrictive strategy?

Historically, transfusions were administered to optimize oxygen delivery to organs in the presence of anemia. However, studies have highlighted the risks associated with transfusions, such as transfusion-related lung injury, circulatory overload, and increased nosocomial infections. These risks are particularly pronounced in critically ill patients, who are often more vulnerable to complications from any additional physiological burden.

The restrictive approach—typically recommended at a hemoglobin threshold of 7 to 8 g/dL—has been shown to be the safer alternative for most ICU patients, as highlighted in recently published clinical guidelines. The data supporting this approach suggest that a restrictive transfusion strategy not only spares patients unnecessary transfusions but also aligns with cost-effective and resource-efficient health care practices.

Key recommendations

For ICU providers, this guideline presents specific recommendations based on a patient’s condition:

• General critical illness: The restrictive approach is preferred over a permissive one, with no adverse effect on ICU mortality, one-year survival, or adverse events. In other words, lower Hgb thresholds do not correlate with poorer outcomes in most critically ill patients.

• Acute gastrointestinal bleeding: Evidence favors a restrictive approach, associated with reduced rebleeding risk and short-term mortality. Studies show a significantly lower incidence of transfusion reactions and costs without compromising patient safety.

• Acute coronary syndrome (ACS): A more cautious approach is advised here. In cases of ACS, a restrictive RBC transfusion strategy could potentially increase the risk of cardiac death. It is recommended to avoid a restrictive approach, as it remains unclear whether there is a gradient effect—where risk progressively increases below a hemoglobin level of 10 g/dL—or a threshold effect at 10 g/dL. In other words, the data does not clarify if a hemoglobin level of 9 g/dL is as safe as 10 g/dL. An individualized transfusion approach, considering patient symptoms and other physiological markers, is recommended.

• Post-cardiac surgery: For postoperative patients, a restrictive strategy is suggested, as it conserves RBCs without impacting outcomes such as mortality or length of hospital stay.

• Isolated troponin elevation: In cases of elevated troponin without evidence of cardiac ischemia, transfusion decisions should consider additional patient-specific variables, with a restrictive approach as the baseline.

• Septic shock: RBC transfusions as part of a resuscitation bundle were not analyzed, as isolating the impact of RBC transfusions from other bundle elements was not feasible. However, with no clear benefit and similar adverse effects, neither strategy proved clinically superior. Nonetheless, a restrictive approach conserves RBC units, thereby saving resources and reducing costs.

The economics of restriction

Beyond clinical benefits, a restrictive approach conserves precious health care resources. With the cost of a single RBC unit hovering around $200—and significantly higher once administrative and logistic expenses are accounted for—reducing unnecessary transfusions translates into substantial savings. For a health care system already strained by limited blood supply and rising demand, a 40% reduction in transfusions across ICUs could alleviate supply pressures and contribute to more equitable resource distribution.

Easier said than done

Adopting a restrictive transfusion policy is not without challenges. Clinicians are trained to act decisively in critical situations, and, often, the instinct is to do more rather than less. However, studies indicate that with proper education, awareness, and decision-support systems, a restrictive policy is both feasible and effective. Institutions may consider behavior modification strategies, such as standardized transfusion order sets and decision-support tools within electronic medical records, to aid in adjusting transfusion practices.

Call to action

The message is clear: For most critically ill patients, a restrictive RBC transfusion strategy is not only safe but optimal. For ICU teams, this calls for a proactive shift in approach. It is a call to scrutinize transfusion triggers and lean toward a judicious, evidence-based approach.

While cases like ACS may require a different approach, the evidence strongly supports that, under most circumstances, less is more. Embracing this approach requires careful consideration, yet the potential benefits for patient safety and health care sustainability are compelling.

As critical care professionals, let us lead the way in refining transfusion practices to uphold patient safety, optimize resources, and adapt to evidence-based guidelines.



ACCESS THE FULL GUIDELINE

WASHINGTON — Investigational treatments aimed specifically at reducing pain in knee osteoarthritis (OA) are moving forward in parallel with disease-modifying approaches.

“We still have very few treatments for the pain of osteoarthritis…It worries me that people think the only way forward is structure modification. I think while we’re waiting for some drugs to be structure modifying, we still need more pain relief. About 70% of people can’t tolerate or shouldn’t be on a [nonsteroidal anti-inflammatory drug], and that leaves a large number of people with pain,” Philip Conaghan, MBBS, PhD, Chair of Musculoskeletal Medicine at the University of Leeds in England, said in an interview.

At the annual meeting of the American College of Rheumatology, Conaghan, who is also honorary consultant rheumatologist for the Leeds Teaching Hospitals NHS Trust, presented new data for two novel approaches, both targeting peripheral nociceptive pain signaling.

In a late-breaking poster, he presented phase 2 trial data on RTX-GRT7039 (resiniferatoxin [RTX]), an agonist of the transient receptor potential vanilloid 1 that is a driver of OA pain. The trial investigated the efficacy and safety of a single intra-articular injection of RTX-GRT7039 in people with knee OA.

And separately, in a late-breaking oral abstract session, Conaghan presented phase 2 trial safety and efficacy data for another investigational agent called LEVI-04, a first-in-class neurotrophin receptor fusion protein (p75NTR-Fc) that supplements the endogenous protein and provides analgesia via inhibition of NT-3 activity.

“I think both have potential to provide good pain relief, through slightly different mechanisms,” Conaghan said in an interview.

Asked to comment, session moderator Gregory C. Gardner, MD, emeritus professor in the Division of Rheumatology at the University of Washington, Seattle, said in an interview: “I think the results are really exciting terms of the ability to control pain to a significant degree in patients with osteoarthritis.”

However, Gardner also said, “The molecules can be very expensive ... so who do we give them to? Will insurance companies pay for this simply for OA pain? They improve function ... so clearly, [they] will be a boon to treating osteoarthritis, but do we give them to people with only more advanced forms of osteoarthritis or earlier on?”

Moreover, Gardner said, “One of my concerns about treating osteoarthritis is I don’t want to do too good of a job treating pain in somebody who has a biomechanically abnormal joint. ... You’ve got a knee that’s worn out some of the cartilage, and now you feel like you can go out and play soccer again. That’s not a good thing. That joint will wear out very quickly, even though it doesn’t feel pain.”

Another OA expert, Matlock Jeffries, MD, director of the Arthritis Research Unit at the Oklahoma Medical Research Foundation, Oklahoma City, said in an interview, “I think we don’t focus nearly enough on pain, and that’s [partly] because the [Food and Drug Administration] has defined endpoints for knee OA trials that are radiographic. ... Patients do not care what their joint space narrowing is. They care what their pain is. And joint space changes and pain do not correlate in knee OA. ... About 20% or 30% of patients who have completely normal x-rays have a lot of pain…I hope that we’ll have some new OA pain therapeutics in the future because that’s what patients actually care about.”

But Jeffries noted that it will be very important to ensure that these agents don’t produce significant side effects, as had been seen previously in several large industry-sponsored trials of drugs targeting nerve growth factors.

“The big concern that we have in the field ... is that the nerve growth factor antibody trials were all stopped because there was a low but persistent risk of rapidly progressive OA in a small percent of patients. I think one of the questions in the field is whether targeting other things having to do with OA pain is going to result in similar bad outcomes. I think the answer is probably not, but that’s one thing that people do worry about, and they never really figured out why the [rapidly progressive OA] was happening.”

 

‘Potential to Provide Meaningful and Sustained Analgesia’

The phase 2 trial of RTX-GRT7039, funded by manufacturer Grünenthal, enrolled 40 patients with a baseline visual analog pain score (VAS) of > 40 mm on motion for average joint pain in the target knee over the past 2 days with or without analgesic medication and Kellgren-Lawrence grades 2-4.

They were randomized to receive a single intra-articular injection of 2 mg or 4 mg RTX-GRT7039 within 1 minute after receiving 5 mL ropivacaine (0.5%) or 4 mg or 8 mg RTX-GRT7039 administered 15 minutes after 5 mL ropivacaine pretreatment, or equivalent placebo treatments plus ropivacaine.

Plasma samples were collected for up to 2 hours, and VAS pain scores were collected for up to 3 hours post injection.

Reductions in VAS scores from baseline in the treated knee were seen in all RTX treatment groups as early as day 8 post injection and were maintained up to 6 months, while no reductions in VAS pain on motion scores were seen in the placebo group.

At 3 months, the absolute baseline-adjusted reductions in VAS scores were similar for RTX 2 mg (–39.75), RTX 4 mg (–40.20), and RTX 8 mg (–30.25), while the reduction in the placebo group was just –8.50. At 6 months, the mean absolute reduction in VAS score was numerically greater in the RTX 2-mg (–46.49), RTX 4-mg (–43.40), and RTX 8-mg (–38.60) groups vs the group that received RTX 4 mg within 1 minute after receiving ropivacaine (–22.00).

At both 3 and 6 months, a higher proportion of patients receiving any dose of RTX-GRT7039 achieved ≥ 50% and ≥ 70% reduction in pain on motion, compared with those who received placebo. All RTX-GRT7039 treatment groups reported a greater improvement in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score than the placebo group at both 3 and 6 months.

Rates of treatment-emergent adverse events were similar between the RTX groups (85.7%-90.9%) and placebo (85.7%) and slightly lower in the group that received RTX 4 mg within 1 minute of receiving ropivacaine (60.0%).

There was a trend toward greater procedural/injection site pain in the RTX treatment groups, compared with placebo, most commonly arthralgia (37.5%), headache (17.5%), and back pain (10%). This tended to peak around 0.5 hours post injection and resolve by 1.5-3.0 hours.

No treatment-related serious adverse events occurred, and no treatment-emergent adverse events led to discontinuation or death.

“This early-phase trial indicates that RTX-GRT7039 has the potential to provide meaningful and sustained analgesia for patients with knee OA pain,” Conaghan and colleagues wrote in their poster.

The drug is now being evaluated in three phase 3 trials (NCT05248386, NCT05449132, and NCT05377489).

 

LEVI-04: Modulation of NT-3 Appears to Work Safely

LEVI-04 was evaluated in a phase 2, 20-week, 13-center (Europe and Hong Kong) randomized, double-blind, placebo-controlled trial in 518 people with knee OA who had WOMAC pain subscale scores ≥ 20, mean average daily pain numeric rating scale score of 4-9, and radiographic Kellgren-Lawrence grade ≥ 2.

They were randomized to a total of five infusions of placebo or 0.3 mg/kg, 0.1 mg/kg, or 2 mg/kg LEVI-04 from baseline through week 16, with safety follow-up to week 30.

The primary endpoint, change in WOMAC pain from baseline to weeks 5 and 17, was met for all three doses. At 17 weeks, those were –2.79, –2.89, and –3.08 for 0.3 mg, 1.0 mg, and 2 mg, respectively, vs –2.28 for placebo (all P < .05).

Secondary endpoints, including WOMAC physical function, WOMAC stiffness, and Patient Global Assessment, and > 50% pain responders, were also all met at weeks 5 and 17. More than 50% of the LEVI-04–treated patients reported ≥ 50% reduction in pain, and > 25% reported ≥ 75% reduction at weeks 5 and 17.

“So, this modulation of NT-3 is working,” Conaghan commented.

There were no increased incidences of severe adverse events, treatment-emergent adverse events, or joint pathologies, including rapidly progressive OA, compared with placebo.

There were more paresthesias reported with the active drug, 2-4 vs 1 with placebo. “That says to me that the drug is working and that it’s having an effect on peripheral nerves, but luckily these were all mild or moderate and didn’t lead to any study withdrawal or discontinuation,” Conaghan said.

Phase 3 trials are in the planning stages, he noted.

 

Other Approaches to Treating OA Pain

Other approaches to treating OA pain have included methotrexate, for which Conaghan was also a coauthor on one paper that came out earlier in 2024. “This presumably works by treating inflammation, but it’s not clear if that is within-joint inflammation or systemic inflammation,” he said in an interview.

Another approach, using the weight loss drug semaglutide, was presented in April 2024 at the 2024 World Congress on Osteoarthritis annual meeting and published in October 2024 in The New England Journal of Medicine

The trial involving RTX-GRT7039 was funded by Grünenthal, and some study coauthors are employees of the company. The trial involving LEVI-04 was funded by Levicept, and some study coauthors are employees of the company. Conaghan is a consultant and/or speaker for Eli Lilly, Eupraxia Pharmaceuticals, Formation Bio, Galapagos, Genascence, GlaxoSmithKline, Grünenthal, Janssen Pharmaceuticals, Kolon TissueGene, Levicept, Medipost, Moebius, Novartis, Pacira, Sandoz, Stryker Corporation, and Takeda. Gardner and Jeffries had no disclosures.

A version of this article appeared on Medscape.com.

WASHINGTON — Investigational treatments aimed specifically at reducing pain in knee osteoarthritis (OA) are moving forward in parallel with disease-modifying approaches.

“We still have very few treatments for the pain of osteoarthritis…It worries me that people think the only way forward is structure modification. I think while we’re waiting for some drugs to be structure modifying, we still need more pain relief. About 70% of people can’t tolerate or shouldn’t be on a [nonsteroidal anti-inflammatory drug], and that leaves a large number of people with pain,” Philip Conaghan, MBBS, PhD, Chair of Musculoskeletal Medicine at the University of Leeds in England, said in an interview.

At the annual meeting of the American College of Rheumatology, Conaghan, who is also honorary consultant rheumatologist for the Leeds Teaching Hospitals NHS Trust, presented new data for two novel approaches, both targeting peripheral nociceptive pain signaling.

In a late-breaking poster, he presented phase 2 trial data on RTX-GRT7039 (resiniferatoxin [RTX]), an agonist of the transient receptor potential vanilloid 1 that is a driver of OA pain. The trial investigated the efficacy and safety of a single intra-articular injection of RTX-GRT7039 in people with knee OA.

And separately, in a late-breaking oral abstract session, Conaghan presented phase 2 trial safety and efficacy data for another investigational agent called LEVI-04, a first-in-class neurotrophin receptor fusion protein (p75NTR-Fc) that supplements the endogenous protein and provides analgesia via inhibition of NT-3 activity.

“I think both have potential to provide good pain relief, through slightly different mechanisms,” Conaghan said in an interview.

Asked to comment, session moderator Gregory C. Gardner, MD, emeritus professor in the Division of Rheumatology at the University of Washington, Seattle, said in an interview: “I think the results are really exciting terms of the ability to control pain to a significant degree in patients with osteoarthritis.”

However, Gardner also said, “The molecules can be very expensive ... so who do we give them to? Will insurance companies pay for this simply for OA pain? They improve function ... so clearly, [they] will be a boon to treating osteoarthritis, but do we give them to people with only more advanced forms of osteoarthritis or earlier on?”

Moreover, Gardner said, “One of my concerns about treating osteoarthritis is I don’t want to do too good of a job treating pain in somebody who has a biomechanically abnormal joint. ... You’ve got a knee that’s worn out some of the cartilage, and now you feel like you can go out and play soccer again. That’s not a good thing. That joint will wear out very quickly, even though it doesn’t feel pain.”

Another OA expert, Matlock Jeffries, MD, director of the Arthritis Research Unit at the Oklahoma Medical Research Foundation, Oklahoma City, said in an interview, “I think we don’t focus nearly enough on pain, and that’s [partly] because the [Food and Drug Administration] has defined endpoints for knee OA trials that are radiographic. ... Patients do not care what their joint space narrowing is. They care what their pain is. And joint space changes and pain do not correlate in knee OA. ... About 20% or 30% of patients who have completely normal x-rays have a lot of pain…I hope that we’ll have some new OA pain therapeutics in the future because that’s what patients actually care about.”

But Jeffries noted that it will be very important to ensure that these agents don’t produce significant side effects, as had been seen previously in several large industry-sponsored trials of drugs targeting nerve growth factors.

“The big concern that we have in the field ... is that the nerve growth factor antibody trials were all stopped because there was a low but persistent risk of rapidly progressive OA in a small percent of patients. I think one of the questions in the field is whether targeting other things having to do with OA pain is going to result in similar bad outcomes. I think the answer is probably not, but that’s one thing that people do worry about, and they never really figured out why the [rapidly progressive OA] was happening.”

 

‘Potential to Provide Meaningful and Sustained Analgesia’

The phase 2 trial of RTX-GRT7039, funded by manufacturer Grünenthal, enrolled 40 patients with a baseline visual analog pain score (VAS) of > 40 mm on motion for average joint pain in the target knee over the past 2 days with or without analgesic medication and Kellgren-Lawrence grades 2-4.

They were randomized to receive a single intra-articular injection of 2 mg or 4 mg RTX-GRT7039 within 1 minute after receiving 5 mL ropivacaine (0.5%) or 4 mg or 8 mg RTX-GRT7039 administered 15 minutes after 5 mL ropivacaine pretreatment, or equivalent placebo treatments plus ropivacaine.

Plasma samples were collected for up to 2 hours, and VAS pain scores were collected for up to 3 hours post injection.

Reductions in VAS scores from baseline in the treated knee were seen in all RTX treatment groups as early as day 8 post injection and were maintained up to 6 months, while no reductions in VAS pain on motion scores were seen in the placebo group.

At 3 months, the absolute baseline-adjusted reductions in VAS scores were similar for RTX 2 mg (–39.75), RTX 4 mg (–40.20), and RTX 8 mg (–30.25), while the reduction in the placebo group was just –8.50. At 6 months, the mean absolute reduction in VAS score was numerically greater in the RTX 2-mg (–46.49), RTX 4-mg (–43.40), and RTX 8-mg (–38.60) groups vs the group that received RTX 4 mg within 1 minute after receiving ropivacaine (–22.00).

At both 3 and 6 months, a higher proportion of patients receiving any dose of RTX-GRT7039 achieved ≥ 50% and ≥ 70% reduction in pain on motion, compared with those who received placebo. All RTX-GRT7039 treatment groups reported a greater improvement in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score than the placebo group at both 3 and 6 months.

Rates of treatment-emergent adverse events were similar between the RTX groups (85.7%-90.9%) and placebo (85.7%) and slightly lower in the group that received RTX 4 mg within 1 minute of receiving ropivacaine (60.0%).

There was a trend toward greater procedural/injection site pain in the RTX treatment groups, compared with placebo, most commonly arthralgia (37.5%), headache (17.5%), and back pain (10%). This tended to peak around 0.5 hours post injection and resolve by 1.5-3.0 hours.

No treatment-related serious adverse events occurred, and no treatment-emergent adverse events led to discontinuation or death.

“This early-phase trial indicates that RTX-GRT7039 has the potential to provide meaningful and sustained analgesia for patients with knee OA pain,” Conaghan and colleagues wrote in their poster.

The drug is now being evaluated in three phase 3 trials (NCT05248386, NCT05449132, and NCT05377489).

 

LEVI-04: Modulation of NT-3 Appears to Work Safely

LEVI-04 was evaluated in a phase 2, 20-week, 13-center (Europe and Hong Kong) randomized, double-blind, placebo-controlled trial in 518 people with knee OA who had WOMAC pain subscale scores ≥ 20, mean average daily pain numeric rating scale score of 4-9, and radiographic Kellgren-Lawrence grade ≥ 2.

They were randomized to a total of five infusions of placebo or 0.3 mg/kg, 0.1 mg/kg, or 2 mg/kg LEVI-04 from baseline through week 16, with safety follow-up to week 30.

The primary endpoint, change in WOMAC pain from baseline to weeks 5 and 17, was met for all three doses. At 17 weeks, those were –2.79, –2.89, and –3.08 for 0.3 mg, 1.0 mg, and 2 mg, respectively, vs –2.28 for placebo (all P < .05).

Secondary endpoints, including WOMAC physical function, WOMAC stiffness, and Patient Global Assessment, and > 50% pain responders, were also all met at weeks 5 and 17. More than 50% of the LEVI-04–treated patients reported ≥ 50% reduction in pain, and > 25% reported ≥ 75% reduction at weeks 5 and 17.

“So, this modulation of NT-3 is working,” Conaghan commented.

There were no increased incidences of severe adverse events, treatment-emergent adverse events, or joint pathologies, including rapidly progressive OA, compared with placebo.

There were more paresthesias reported with the active drug, 2-4 vs 1 with placebo. “That says to me that the drug is working and that it’s having an effect on peripheral nerves, but luckily these were all mild or moderate and didn’t lead to any study withdrawal or discontinuation,” Conaghan said.

Phase 3 trials are in the planning stages, he noted.

 

Other Approaches to Treating OA Pain

Other approaches to treating OA pain have included methotrexate, for which Conaghan was also a coauthor on one paper that came out earlier in 2024. “This presumably works by treating inflammation, but it’s not clear if that is within-joint inflammation or systemic inflammation,” he said in an interview.

Another approach, using the weight loss drug semaglutide, was presented in April 2024 at the 2024 World Congress on Osteoarthritis annual meeting and published in October 2024 in The New England Journal of Medicine

The trial involving RTX-GRT7039 was funded by Grünenthal, and some study coauthors are employees of the company. The trial involving LEVI-04 was funded by Levicept, and some study coauthors are employees of the company. Conaghan is a consultant and/or speaker for Eli Lilly, Eupraxia Pharmaceuticals, Formation Bio, Galapagos, Genascence, GlaxoSmithKline, Grünenthal, Janssen Pharmaceuticals, Kolon TissueGene, Levicept, Medipost, Moebius, Novartis, Pacira, Sandoz, Stryker Corporation, and Takeda. Gardner and Jeffries had no disclosures.

A version of this article appeared on Medscape.com.

WASHINGTON — Investigational treatments aimed specifically at reducing pain in knee osteoarthritis (OA) are moving forward in parallel with disease-modifying approaches.

“We still have very few treatments for the pain of osteoarthritis…It worries me that people think the only way forward is structure modification. I think while we’re waiting for some drugs to be structure modifying, we still need more pain relief. About 70% of people can’t tolerate or shouldn’t be on a [nonsteroidal anti-inflammatory drug], and that leaves a large number of people with pain,” Philip Conaghan, MBBS, PhD, Chair of Musculoskeletal Medicine at the University of Leeds in England, said in an interview.

At the annual meeting of the American College of Rheumatology, Conaghan, who is also honorary consultant rheumatologist for the Leeds Teaching Hospitals NHS Trust, presented new data for two novel approaches, both targeting peripheral nociceptive pain signaling.

In a late-breaking poster, he presented phase 2 trial data on RTX-GRT7039 (resiniferatoxin [RTX]), an agonist of the transient receptor potential vanilloid 1 that is a driver of OA pain. The trial investigated the efficacy and safety of a single intra-articular injection of RTX-GRT7039 in people with knee OA.

And separately, in a late-breaking oral abstract session, Conaghan presented phase 2 trial safety and efficacy data for another investigational agent called LEVI-04, a first-in-class neurotrophin receptor fusion protein (p75NTR-Fc) that supplements the endogenous protein and provides analgesia via inhibition of NT-3 activity.

“I think both have potential to provide good pain relief, through slightly different mechanisms,” Conaghan said in an interview.

Asked to comment, session moderator Gregory C. Gardner, MD, emeritus professor in the Division of Rheumatology at the University of Washington, Seattle, said in an interview: “I think the results are really exciting terms of the ability to control pain to a significant degree in patients with osteoarthritis.”

However, Gardner also said, “The molecules can be very expensive ... so who do we give them to? Will insurance companies pay for this simply for OA pain? They improve function ... so clearly, [they] will be a boon to treating osteoarthritis, but do we give them to people with only more advanced forms of osteoarthritis or earlier on?”

Moreover, Gardner said, “One of my concerns about treating osteoarthritis is I don’t want to do too good of a job treating pain in somebody who has a biomechanically abnormal joint. ... You’ve got a knee that’s worn out some of the cartilage, and now you feel like you can go out and play soccer again. That’s not a good thing. That joint will wear out very quickly, even though it doesn’t feel pain.”

Another OA expert, Matlock Jeffries, MD, director of the Arthritis Research Unit at the Oklahoma Medical Research Foundation, Oklahoma City, said in an interview, “I think we don’t focus nearly enough on pain, and that’s [partly] because the [Food and Drug Administration] has defined endpoints for knee OA trials that are radiographic. ... Patients do not care what their joint space narrowing is. They care what their pain is. And joint space changes and pain do not correlate in knee OA. ... About 20% or 30% of patients who have completely normal x-rays have a lot of pain…I hope that we’ll have some new OA pain therapeutics in the future because that’s what patients actually care about.”

But Jeffries noted that it will be very important to ensure that these agents don’t produce significant side effects, as had been seen previously in several large industry-sponsored trials of drugs targeting nerve growth factors.

“The big concern that we have in the field ... is that the nerve growth factor antibody trials were all stopped because there was a low but persistent risk of rapidly progressive OA in a small percent of patients. I think one of the questions in the field is whether targeting other things having to do with OA pain is going to result in similar bad outcomes. I think the answer is probably not, but that’s one thing that people do worry about, and they never really figured out why the [rapidly progressive OA] was happening.”

 

‘Potential to Provide Meaningful and Sustained Analgesia’

The phase 2 trial of RTX-GRT7039, funded by manufacturer Grünenthal, enrolled 40 patients with a baseline visual analog pain score (VAS) of > 40 mm on motion for average joint pain in the target knee over the past 2 days with or without analgesic medication and Kellgren-Lawrence grades 2-4.

They were randomized to receive a single intra-articular injection of 2 mg or 4 mg RTX-GRT7039 within 1 minute after receiving 5 mL ropivacaine (0.5%) or 4 mg or 8 mg RTX-GRT7039 administered 15 minutes after 5 mL ropivacaine pretreatment, or equivalent placebo treatments plus ropivacaine.

Plasma samples were collected for up to 2 hours, and VAS pain scores were collected for up to 3 hours post injection.

Reductions in VAS scores from baseline in the treated knee were seen in all RTX treatment groups as early as day 8 post injection and were maintained up to 6 months, while no reductions in VAS pain on motion scores were seen in the placebo group.

At 3 months, the absolute baseline-adjusted reductions in VAS scores were similar for RTX 2 mg (–39.75), RTX 4 mg (–40.20), and RTX 8 mg (–30.25), while the reduction in the placebo group was just –8.50. At 6 months, the mean absolute reduction in VAS score was numerically greater in the RTX 2-mg (–46.49), RTX 4-mg (–43.40), and RTX 8-mg (–38.60) groups vs the group that received RTX 4 mg within 1 minute after receiving ropivacaine (–22.00).

At both 3 and 6 months, a higher proportion of patients receiving any dose of RTX-GRT7039 achieved ≥ 50% and ≥ 70% reduction in pain on motion, compared with those who received placebo. All RTX-GRT7039 treatment groups reported a greater improvement in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score than the placebo group at both 3 and 6 months.

Rates of treatment-emergent adverse events were similar between the RTX groups (85.7%-90.9%) and placebo (85.7%) and slightly lower in the group that received RTX 4 mg within 1 minute of receiving ropivacaine (60.0%).

There was a trend toward greater procedural/injection site pain in the RTX treatment groups, compared with placebo, most commonly arthralgia (37.5%), headache (17.5%), and back pain (10%). This tended to peak around 0.5 hours post injection and resolve by 1.5-3.0 hours.

No treatment-related serious adverse events occurred, and no treatment-emergent adverse events led to discontinuation or death.

“This early-phase trial indicates that RTX-GRT7039 has the potential to provide meaningful and sustained analgesia for patients with knee OA pain,” Conaghan and colleagues wrote in their poster.

The drug is now being evaluated in three phase 3 trials (NCT05248386, NCT05449132, and NCT05377489).

 

LEVI-04: Modulation of NT-3 Appears to Work Safely

LEVI-04 was evaluated in a phase 2, 20-week, 13-center (Europe and Hong Kong) randomized, double-blind, placebo-controlled trial in 518 people with knee OA who had WOMAC pain subscale scores ≥ 20, mean average daily pain numeric rating scale score of 4-9, and radiographic Kellgren-Lawrence grade ≥ 2.

They were randomized to a total of five infusions of placebo or 0.3 mg/kg, 0.1 mg/kg, or 2 mg/kg LEVI-04 from baseline through week 16, with safety follow-up to week 30.

The primary endpoint, change in WOMAC pain from baseline to weeks 5 and 17, was met for all three doses. At 17 weeks, those were –2.79, –2.89, and –3.08 for 0.3 mg, 1.0 mg, and 2 mg, respectively, vs –2.28 for placebo (all P < .05).

Secondary endpoints, including WOMAC physical function, WOMAC stiffness, and Patient Global Assessment, and > 50% pain responders, were also all met at weeks 5 and 17. More than 50% of the LEVI-04–treated patients reported ≥ 50% reduction in pain, and > 25% reported ≥ 75% reduction at weeks 5 and 17.

“So, this modulation of NT-3 is working,” Conaghan commented.

There were no increased incidences of severe adverse events, treatment-emergent adverse events, or joint pathologies, including rapidly progressive OA, compared with placebo.

There were more paresthesias reported with the active drug, 2-4 vs 1 with placebo. “That says to me that the drug is working and that it’s having an effect on peripheral nerves, but luckily these were all mild or moderate and didn’t lead to any study withdrawal or discontinuation,” Conaghan said.

Phase 3 trials are in the planning stages, he noted.

 

Other Approaches to Treating OA Pain

Other approaches to treating OA pain have included methotrexate, for which Conaghan was also a coauthor on one paper that came out earlier in 2024. “This presumably works by treating inflammation, but it’s not clear if that is within-joint inflammation or systemic inflammation,” he said in an interview.

Another approach, using the weight loss drug semaglutide, was presented in April 2024 at the 2024 World Congress on Osteoarthritis annual meeting and published in October 2024 in The New England Journal of Medicine

The trial involving RTX-GRT7039 was funded by Grünenthal, and some study coauthors are employees of the company. The trial involving LEVI-04 was funded by Levicept, and some study coauthors are employees of the company. Conaghan is a consultant and/or speaker for Eli Lilly, Eupraxia Pharmaceuticals, Formation Bio, Galapagos, Genascence, GlaxoSmithKline, Grünenthal, Janssen Pharmaceuticals, Kolon TissueGene, Levicept, Medipost, Moebius, Novartis, Pacira, Sandoz, Stryker Corporation, and Takeda. Gardner and Jeffries had no disclosures.

A version of this article appeared on Medscape.com.

TOPLINE:

Patients with serum ferritin levels higher than 1000 μg/L show a 91% increased risk for any fracture, with a doubled risk for vertebral and humerus fractures compared with those without iron overload.

 

METHODOLOGY:

• Iron overload’s association with decreased bone mineral density is established, but its relationship to osteoporotic fracture risk has remained understudied and inconsistent across fracture sites.
• Researchers conducted a population-based cohort study using a UK general practice database to evaluate the fracture risk in 20,264 patients with iron overload and 192,956 matched controls without elevated ferritin (mean age, 57 years; about 40% women).
• Patients with iron overload were identified as those with laboratory-confirmed iron overload (serum ferritin levels > 1000 μg/L; n = 13,510) or a diagnosis of an iron overloading disorder, such as thalassemia major, sickle cell disease, or hemochromatosis (n = 6754).
• The primary outcome of interest was the first occurrence of an osteoporotic fracture after the diagnosis of iron overload or first record of high ferritin.
• A sensitivity analysis was conducted to check the impact of laboratory-confirmed iron overload on the risk for osteoporotic fracture compared with a diagnosis code without elevated ferritin.

TAKEAWAY:

• In the overall cohort, patients with iron overload had a 55% higher risk for any osteoporotic fracture than control individuals (adjusted hazard ratio [aHR], 1.55; 95% CI, 1.42-1.68), with the highest risk observed for vertebral fractures (aHR, 1.97; 95% CI, 1.63-2.37) and humerus fractures (aHR, 1.91; 95% CI, 1.61-2.26).
• Patients with laboratory-confirmed iron overload showed a 91% increased risk for any fracture (aHR, 1.91; 95% CI, 1.73-2.10), with a 2.5-fold higher risk observed for vertebral fractures (aHR, 2.51; 95% CI, 2.01-3.12), followed by humerus fractures (aHR, 2.41; 95% CI, 1.96-2.95).
• There was no increased risk for fracture at any site in patients with a diagnosis of an iron overloading disorder but no laboratory-confirmed iron overload.
• No sex-specific differences were identified in the association between iron overload and fracture risk.

IN PRACTICE:

“The main clinical message from our findings is that clinicians should consider iron overloading as a risk factor for fracture. Importantly, among high-risk patients presenting with serum ferritin values exceeding 1000 μg/L, osteoporosis screening and treatment strategies should be initiated in accordance with the guidelines for patients with hepatic disease,” the authors wrote.

 

SOURCE:

The study was led by Andrea Michelle Burden, PhD, Institute of Pharmaceutical Sciences, Department of Chemistry and Applied Biosciences, ETH Zürich in Switzerland, and was published online in The Journal of Clinical Endocrinology & Metabolism.

 

LIMITATIONS:

The study could not assess the duration of iron overload on fracture risk, and thus, patients could enter the cohort with a single elevated serum ferritin value that may not have reflected systemic iron overload. The authors also acknowledged potential exposure misclassification among matched control individuals because only 2.9% had a serum ferritin value available at baseline. Also, researchers were unable to adjust for inflammation status due to the limited availability of C-reactive protein measurements and the lack of leukocyte count data in primary care settings.

 

DISCLOSURES:

This study received support through grants from the German Research Foundation. The authors declared no conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

TOPLINE:

Patients with serum ferritin levels higher than 1000 μg/L show a 91% increased risk for any fracture, with a doubled risk for vertebral and humerus fractures compared with those without iron overload.

 

METHODOLOGY:

• Iron overload’s association with decreased bone mineral density is established, but its relationship to osteoporotic fracture risk has remained understudied and inconsistent across fracture sites.
• Researchers conducted a population-based cohort study using a UK general practice database to evaluate the fracture risk in 20,264 patients with iron overload and 192,956 matched controls without elevated ferritin (mean age, 57 years; about 40% women).
• Patients with iron overload were identified as those with laboratory-confirmed iron overload (serum ferritin levels > 1000 μg/L; n = 13,510) or a diagnosis of an iron overloading disorder, such as thalassemia major, sickle cell disease, or hemochromatosis (n = 6754).
• The primary outcome of interest was the first occurrence of an osteoporotic fracture after the diagnosis of iron overload or first record of high ferritin.
• A sensitivity analysis was conducted to check the impact of laboratory-confirmed iron overload on the risk for osteoporotic fracture compared with a diagnosis code without elevated ferritin.

TAKEAWAY:

• In the overall cohort, patients with iron overload had a 55% higher risk for any osteoporotic fracture than control individuals (adjusted hazard ratio [aHR], 1.55; 95% CI, 1.42-1.68), with the highest risk observed for vertebral fractures (aHR, 1.97; 95% CI, 1.63-2.37) and humerus fractures (aHR, 1.91; 95% CI, 1.61-2.26).
• Patients with laboratory-confirmed iron overload showed a 91% increased risk for any fracture (aHR, 1.91; 95% CI, 1.73-2.10), with a 2.5-fold higher risk observed for vertebral fractures (aHR, 2.51; 95% CI, 2.01-3.12), followed by humerus fractures (aHR, 2.41; 95% CI, 1.96-2.95).
• There was no increased risk for fracture at any site in patients with a diagnosis of an iron overloading disorder but no laboratory-confirmed iron overload.
• No sex-specific differences were identified in the association between iron overload and fracture risk.

IN PRACTICE:

“The main clinical message from our findings is that clinicians should consider iron overloading as a risk factor for fracture. Importantly, among high-risk patients presenting with serum ferritin values exceeding 1000 μg/L, osteoporosis screening and treatment strategies should be initiated in accordance with the guidelines for patients with hepatic disease,” the authors wrote.

 

SOURCE:

The study was led by Andrea Michelle Burden, PhD, Institute of Pharmaceutical Sciences, Department of Chemistry and Applied Biosciences, ETH Zürich in Switzerland, and was published online in The Journal of Clinical Endocrinology & Metabolism.

 

LIMITATIONS:

The study could not assess the duration of iron overload on fracture risk, and thus, patients could enter the cohort with a single elevated serum ferritin value that may not have reflected systemic iron overload. The authors also acknowledged potential exposure misclassification among matched control individuals because only 2.9% had a serum ferritin value available at baseline. Also, researchers were unable to adjust for inflammation status due to the limited availability of C-reactive protein measurements and the lack of leukocyte count data in primary care settings.

 

DISCLOSURES:

This study received support through grants from the German Research Foundation. The authors declared no conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

TOPLINE:

Patients with serum ferritin levels higher than 1000 μg/L show a 91% increased risk for any fracture, with a doubled risk for vertebral and humerus fractures compared with those without iron overload.

 

METHODOLOGY:

• Iron overload’s association with decreased bone mineral density is established, but its relationship to osteoporotic fracture risk has remained understudied and inconsistent across fracture sites.
• Researchers conducted a population-based cohort study using a UK general practice database to evaluate the fracture risk in 20,264 patients with iron overload and 192,956 matched controls without elevated ferritin (mean age, 57 years; about 40% women).
• Patients with iron overload were identified as those with laboratory-confirmed iron overload (serum ferritin levels > 1000 μg/L; n = 13,510) or a diagnosis of an iron overloading disorder, such as thalassemia major, sickle cell disease, or hemochromatosis (n = 6754).
• The primary outcome of interest was the first occurrence of an osteoporotic fracture after the diagnosis of iron overload or first record of high ferritin.
• A sensitivity analysis was conducted to check the impact of laboratory-confirmed iron overload on the risk for osteoporotic fracture compared with a diagnosis code without elevated ferritin.

TAKEAWAY:

• In the overall cohort, patients with iron overload had a 55% higher risk for any osteoporotic fracture than control individuals (adjusted hazard ratio [aHR], 1.55; 95% CI, 1.42-1.68), with the highest risk observed for vertebral fractures (aHR, 1.97; 95% CI, 1.63-2.37) and humerus fractures (aHR, 1.91; 95% CI, 1.61-2.26).
• Patients with laboratory-confirmed iron overload showed a 91% increased risk for any fracture (aHR, 1.91; 95% CI, 1.73-2.10), with a 2.5-fold higher risk observed for vertebral fractures (aHR, 2.51; 95% CI, 2.01-3.12), followed by humerus fractures (aHR, 2.41; 95% CI, 1.96-2.95).
• There was no increased risk for fracture at any site in patients with a diagnosis of an iron overloading disorder but no laboratory-confirmed iron overload.
• No sex-specific differences were identified in the association between iron overload and fracture risk.

IN PRACTICE:

“The main clinical message from our findings is that clinicians should consider iron overloading as a risk factor for fracture. Importantly, among high-risk patients presenting with serum ferritin values exceeding 1000 μg/L, osteoporosis screening and treatment strategies should be initiated in accordance with the guidelines for patients with hepatic disease,” the authors wrote.

 

SOURCE:

The study was led by Andrea Michelle Burden, PhD, Institute of Pharmaceutical Sciences, Department of Chemistry and Applied Biosciences, ETH Zürich in Switzerland, and was published online in The Journal of Clinical Endocrinology & Metabolism.

 

LIMITATIONS:

The study could not assess the duration of iron overload on fracture risk, and thus, patients could enter the cohort with a single elevated serum ferritin value that may not have reflected systemic iron overload. The authors also acknowledged potential exposure misclassification among matched control individuals because only 2.9% had a serum ferritin value available at baseline. Also, researchers were unable to adjust for inflammation status due to the limited availability of C-reactive protein measurements and the lack of leukocyte count data in primary care settings.

 

DISCLOSURES:

This study received support through grants from the German Research Foundation. The authors declared no conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

TOPLINE:

Exposure to individual or mixed per- and polyfluoroalkyl substances (PFASs) is associated with changes in peripheral rather than central thyroid hormone sensitivity.

METHODOLOGY:

• PFASs are widely recognized for their persistence in the environment and potential endocrine-disrupting effects.
• A cross-sectional study investigated associations between PFAS exposures and thyroid homeostasis parameters in adult participants in two National Health and Nutrition Examination Survey cycles (2007-2008 and 2011-2012).
• Participants were required to have complete thyroid hormone profiles and measurements of PFAS concentration, not be pregnant, and not have thyroid disease or a history of using thyroid drugs such as thyroxine, methimazole, and propylthiouracil.
• Levels of six PFASs were measured in the serum: Perfluorooctanoic acid (PFOA), perfluorooctanesulfonic acid (PFOS), perfluorononanoic acid (PFNA), perfluorodecanoic acid, perfluorohexane sulfonic acid (PFHxS), and 2-(N-methyl-perfluorooctane sulfonamido) acetic acid.
• Thyroid homeostasis parameters were assessed using serum concentrations of thyroid hormones.
• Peripheral sensitivity was calculated using the ratio of free triiodothyronine to free thyroxine (FT3/FT4) and the sum activity of peripheral deiodinases (SPINA-GD).
• Central sensitivity was assessed with thyrotroph thyroxine resistance index, thyroid-stimulating hormone index, thyroid feedback quantile–based index (TFQI), and parametric TFQI.

TAKEAWAY:

• Researchers included 2386 adults (mean age, 47.59 years; 53.94% men; 42.88% White).
• FT3/FT4 and SPINA-GD were positively associated with PFOA, PFOS, PFNA, and PFHxS (P < .05 for all) in an adjusted analysis; however, no link was found between central thyroid sensitivity parameters and PFAS exposures.
• Specifically, higher quartiles of PFOA and PFOS concentrations were associated with an increased FT3/FT4 and SPINA-GD, indicating an increased conversion efficiency of FT4 to FT3 or peripheral deiodinase.
• Exposure to a mixture of different PFASs was also positively correlated with FT3/FT4 (beta, 0.013; P < .001) and SPINA-GD (beta, 1.230; P < .001), with PFOA showing the highest contribution.
• Men and smokers showed higher correlations of PFOA with peripheral thyroid hormone sensitivity indicators than women and nonsmokers, respectively.

IN PRACTICE:

“PFAS exposure, especially PFOA and PFOS, mainly impacted peripheral sensitivity to thyroid hormones, instead of central sensitivity,” the authors wrote, adding that their results may support, “taking more steps to prevent and reduce” the harmful effects of PFASs.

SOURCE:

This study was led by Xinwen Yu and Yufei Liu, Department of Endocrinology, The Second Affiliated Hospital of Air Force Medical University, Xi’an, China. It was published online in The Journal of Clinical Endocrinology & Metabolism.

LIMITATIONS:

The cross-sectional design of this study limited the ability to establish causal relationships between PFAS exposure and thyroid function. The assessment of thyroid homeostasis parameters was conducted indirectly by measuring thyroid hormone levels. Inaccuracies in self-reported data on long-term exposure to PFASs and the exclusion of other endocrine-disrupting chemicals may have affected the study’s conclusions.

DISCLOSURES:

This study was supported by grants from the Natural Science Foundation of Shaanxi Province, China; the Key Research and Development Project of Shaanxi Province; and the Clinical Research Program of Air Force Medical University. The authors reported having no relevant conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Exposure to individual or mixed per- and polyfluoroalkyl substances (PFASs) is associated with changes in peripheral rather than central thyroid hormone sensitivity.

METHODOLOGY:

• PFASs are widely recognized for their persistence in the environment and potential endocrine-disrupting effects.
• A cross-sectional study investigated associations between PFAS exposures and thyroid homeostasis parameters in adult participants in two National Health and Nutrition Examination Survey cycles (2007-2008 and 2011-2012).
• Participants were required to have complete thyroid hormone profiles and measurements of PFAS concentration, not be pregnant, and not have thyroid disease or a history of using thyroid drugs such as thyroxine, methimazole, and propylthiouracil.
• Levels of six PFASs were measured in the serum: Perfluorooctanoic acid (PFOA), perfluorooctanesulfonic acid (PFOS), perfluorononanoic acid (PFNA), perfluorodecanoic acid, perfluorohexane sulfonic acid (PFHxS), and 2-(N-methyl-perfluorooctane sulfonamido) acetic acid.
• Thyroid homeostasis parameters were assessed using serum concentrations of thyroid hormones.
• Peripheral sensitivity was calculated using the ratio of free triiodothyronine to free thyroxine (FT3/FT4) and the sum activity of peripheral deiodinases (SPINA-GD).
• Central sensitivity was assessed with thyrotroph thyroxine resistance index, thyroid-stimulating hormone index, thyroid feedback quantile–based index (TFQI), and parametric TFQI.

TAKEAWAY:

• Researchers included 2386 adults (mean age, 47.59 years; 53.94% men; 42.88% White).
• FT3/FT4 and SPINA-GD were positively associated with PFOA, PFOS, PFNA, and PFHxS (P < .05 for all) in an adjusted analysis; however, no link was found between central thyroid sensitivity parameters and PFAS exposures.
• Specifically, higher quartiles of PFOA and PFOS concentrations were associated with an increased FT3/FT4 and SPINA-GD, indicating an increased conversion efficiency of FT4 to FT3 or peripheral deiodinase.
• Exposure to a mixture of different PFASs was also positively correlated with FT3/FT4 (beta, 0.013; P < .001) and SPINA-GD (beta, 1.230; P < .001), with PFOA showing the highest contribution.
• Men and smokers showed higher correlations of PFOA with peripheral thyroid hormone sensitivity indicators than women and nonsmokers, respectively.

IN PRACTICE:

“PFAS exposure, especially PFOA and PFOS, mainly impacted peripheral sensitivity to thyroid hormones, instead of central sensitivity,” the authors wrote, adding that their results may support, “taking more steps to prevent and reduce” the harmful effects of PFASs.

SOURCE:

This study was led by Xinwen Yu and Yufei Liu, Department of Endocrinology, The Second Affiliated Hospital of Air Force Medical University, Xi’an, China. It was published online in The Journal of Clinical Endocrinology & Metabolism.

LIMITATIONS:

The cross-sectional design of this study limited the ability to establish causal relationships between PFAS exposure and thyroid function. The assessment of thyroid homeostasis parameters was conducted indirectly by measuring thyroid hormone levels. Inaccuracies in self-reported data on long-term exposure to PFASs and the exclusion of other endocrine-disrupting chemicals may have affected the study’s conclusions.

DISCLOSURES:

This study was supported by grants from the Natural Science Foundation of Shaanxi Province, China; the Key Research and Development Project of Shaanxi Province; and the Clinical Research Program of Air Force Medical University. The authors reported having no relevant conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Exposure to individual or mixed per- and polyfluoroalkyl substances (PFASs) is associated with changes in peripheral rather than central thyroid hormone sensitivity.

METHODOLOGY:

• PFASs are widely recognized for their persistence in the environment and potential endocrine-disrupting effects.
• A cross-sectional study investigated associations between PFAS exposures and thyroid homeostasis parameters in adult participants in two National Health and Nutrition Examination Survey cycles (2007-2008 and 2011-2012).
• Participants were required to have complete thyroid hormone profiles and measurements of PFAS concentration, not be pregnant, and not have thyroid disease or a history of using thyroid drugs such as thyroxine, methimazole, and propylthiouracil.
• Levels of six PFASs were measured in the serum: Perfluorooctanoic acid (PFOA), perfluorooctanesulfonic acid (PFOS), perfluorononanoic acid (PFNA), perfluorodecanoic acid, perfluorohexane sulfonic acid (PFHxS), and 2-(N-methyl-perfluorooctane sulfonamido) acetic acid.
• Thyroid homeostasis parameters were assessed using serum concentrations of thyroid hormones.
• Peripheral sensitivity was calculated using the ratio of free triiodothyronine to free thyroxine (FT3/FT4) and the sum activity of peripheral deiodinases (SPINA-GD).
• Central sensitivity was assessed with thyrotroph thyroxine resistance index, thyroid-stimulating hormone index, thyroid feedback quantile–based index (TFQI), and parametric TFQI.

TAKEAWAY:

• Researchers included 2386 adults (mean age, 47.59 years; 53.94% men; 42.88% White).
• FT3/FT4 and SPINA-GD were positively associated with PFOA, PFOS, PFNA, and PFHxS (P < .05 for all) in an adjusted analysis; however, no link was found between central thyroid sensitivity parameters and PFAS exposures.
• Specifically, higher quartiles of PFOA and PFOS concentrations were associated with an increased FT3/FT4 and SPINA-GD, indicating an increased conversion efficiency of FT4 to FT3 or peripheral deiodinase.
• Exposure to a mixture of different PFASs was also positively correlated with FT3/FT4 (beta, 0.013; P < .001) and SPINA-GD (beta, 1.230; P < .001), with PFOA showing the highest contribution.
• Men and smokers showed higher correlations of PFOA with peripheral thyroid hormone sensitivity indicators than women and nonsmokers, respectively.

IN PRACTICE:

“PFAS exposure, especially PFOA and PFOS, mainly impacted peripheral sensitivity to thyroid hormones, instead of central sensitivity,” the authors wrote, adding that their results may support, “taking more steps to prevent and reduce” the harmful effects of PFASs.

SOURCE:

This study was led by Xinwen Yu and Yufei Liu, Department of Endocrinology, The Second Affiliated Hospital of Air Force Medical University, Xi’an, China. It was published online in The Journal of Clinical Endocrinology & Metabolism.

LIMITATIONS:

The cross-sectional design of this study limited the ability to establish causal relationships between PFAS exposure and thyroid function. The assessment of thyroid homeostasis parameters was conducted indirectly by measuring thyroid hormone levels. Inaccuracies in self-reported data on long-term exposure to PFASs and the exclusion of other endocrine-disrupting chemicals may have affected the study’s conclusions.

DISCLOSURES:

This study was supported by grants from the Natural Science Foundation of Shaanxi Province, China; the Key Research and Development Project of Shaanxi Province; and the Clinical Research Program of Air Force Medical University. The authors reported having no relevant conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.