Feature

When Amy Moser had a simple urinary tract infection in her late 20s, her doctor prescribed Cipro, a powerful antibiotic used to treat anthrax and some of the most fearsome bacterial infections.

Nearly 2 weeks after she finished her treatment, her left kneecap dislocated while she was trying on a swimsuit at a retail store. Shortly afterward, she had painful ligament ruptures in her wrists, then her shoulder dislocated, followed by three Achilles tendon tears.

“That’s when I fell apart,” says Ms. Moser, a Phoenix health blogger and book author. “From that moment on, for almost the next 2.5 years consistently, I had new tendon tears every few weeks.”

Ms. Moser’s doctors had no answer for what was causing her injuries, all of which required surgical fixes. A married mother of three, she was otherwise healthy and fit. So, after her third Achilles tear, she turned to the FDA’s website for answers. There, she found many warnings about side effects of Cipro, Levaquin, and other so-called fluoroquinolones, including risks for tendon and ligament injuries.

“When all the ruptures started to happen, my doctor kept asking me if I’d ever taken Levaquin, and every time I was like, ‘No.’ So I did what all doctors don’t want you to do: I Googled ‘Levaquin,’ ” she recalls.

Her search led to FDA warnings and articles about the possibility of tendon and ligament ruptures with fluroquinolones.

“That was the first time I’d ever even heard that word ‘fluroquinolones,’ and I found Cipro on that list ... and I realized that I’d just been prescribed that before everything started,” she says.

That was 12 years ago. Since then, the FDA has issued more warnings about fluoroquinolone risks. In that time, Ms. Moser, now 40, has had more than 30 surgeries to correct tendon ruptures and injuries, including a double-knee replacement this year.

“I am in chronic pain all the time,” she says. “I am chronically injured. I have a lot of tears that I’ve not fixed because they’re very complicated, and I don’t know if the rest of my body can handle the strain of recovering from those surgeries.”

Ms. Moser’s is hardly an isolated case. Since the 1980s, more than 60,000 patients have reported hundreds of thousands of serious events linked to fluoroquinolones to the FDA, including 6,575 reports of deaths.

The most common side effects were tendon rupture, as well as neurological and psychiatric symptoms. But experts estimate only 1%-10% of such events are reported to the FDA. That suggests that fluoroquinolones might have harmed hundreds of thousands of people in the United States alone, says Charles Bennett, MD, a hematologist at the University of South Carolina’s College of Pharmacy, Columbia.

Yet despite the many patient reports and FDA warnings on dangerous side effects, many doctors continue to wrongly prescribe fluoroquinolones for simple urinary tract infections, sinus infections, and respiratory issues better treated with less risky antibiotics.

“There probably is overprescription by primary care doctors for urinary tract infections and respiratory infections, when there could be alternatives that are safer to use,” says Amesh Adalja, MD, an infectious disease specialist and senior scholar with the Johns Hopkins Center for Health Security.

“I would say that’s probably the case in the outpatient setting, not necessarily in the hospital setting or among infectious disease doctors ... but I think it’s important to say there are still some judicious uses of fluoroquinolones,” he says. “However, there probably is a lot of injudicious use of fluoroquinolones along with many other antibiotics in the primary care setting.”
 

FDA warnings on fluoroquinolones

Fluoroquinolones are a class of broad-spectrum antibiotics used for decades to treat certain bacterial infections.

FDA-approved fluoroquinolones include ciprofloxacin (Cipro), ciprofloxacin extended-release tablets, delafloxacin (Baxdela), gemifloxacin (Factive) levofloxacin (Levaquin), moxifloxacin (Avelox), and ofloxacin (Floxin). More than 60 generic versions of these brand-name medicines are also on the market, making them among the most prescribed antibiotics in the U.S.

Over the past 2 decades, a wide range of physical and mental health side effects have been tied to fluoroquinolones. As a result of these “adverse event reports” and research published in medical literature, the FDA has required an escalating series of warnings and safety labeling changes for doctors who prescribe these drugs.

• In 2008, the FDA first added a “black box” warning to fluoroquinolones, citing an increased risk of tendinitis and tendon rupture in patients prescribed these meds.
• In 2011, the agency required the warning label to include risks of worsening symptoms for those with myasthenia gravis, a chronic autoimmune disease that causes muscle weakness, vision problems, and speech problems.
• In 2013, regulators required updated labels noting the potential for irreversible peripheral neuropathy (serious nerve damage).
• In 2016, the FDA issued its strongest warning against the use of such antibiotics for simple bacterial infections – such as uncomplicated urinary tract infections (UTIs), acute sinusitis, and acute bronchitis – saying the “association of fluoroquinolones with disabling and potentially permanent side effects involving tendons, muscles, joints, nerves and the central nervous system ... outweighs the benefits for patients.”
• And in 2018, regulators required safety labeling changes to include warnings about the risks of aortic aneurysm – a life-threatening enlargement of the main vessel that delivers blood to the body – as well as mental health side effects and serious blood sugar disturbances.

But FDA regulators have stopped short of barring fluoroquinolone use in the treatment of bacterial infections, citing the benefits for certain conditions.

“For some patients, the benefits of fluoroquinolones may continue to outweigh the risks for treatment of serious bacterial infections, such as pneumonia or intra-abdominal infections,” said former FDA Commissioner Scott Gottlieb, MD, “but there are other serious, known risks associated with these strong antibiotics that must be carefully weighed when considering their use.”

In December 2021, a study published in the journal JAMA Network Open found the FDA’s warnings may have helped lower prescribing of the drugs in Medicare patients. But not all doctors have been responsive to those warnings, researchers found.

“An overall decline in change over time and an immediate change in fluoroquinolone prescribing was observed after the 2016 FDA warning,” the authors concluded. “Certain physicians, such as primary care physicians, were more responsive to FDA warnings than others. ... Findings of this study suggest that identifying the association of physician and organizational characteristics with fluoroquinolone prescribing practices could help in developing mechanisms for improving de-adoption.”

Some critics say the FDA should do more to spotlight the dangers of fluoroquinolones and require doctors and patients to sign checklist consent forms to show they are aware of the potential side effects of these drugs.

Rachel Brummert, a patient advocate who sits on an FDA consumer advisory board, believes the FDA needs to improve its communication to doctors on fluoroquinolone risks and get tougher with those who continue to inappropriately prescribe the drugs.

“I think there needs to be a system in place, where if something comes down from the FDA about a drug, the physician has to sign off on it, the patient has to sign off on it and mark that they understand that there are these ‘black box’ warnings,” says Ms. Brummert, 52, a representative on the FDA’s Medical Devices Advisory Committee.

As an example, she points to Australia’s medical laws requiring doctors and patients to sign a checklist before any fluoroquinolone prescription is approved.

“When a physician prescribes a fluoroquinolone antibiotic, there’s a checklist – does the patient have an infection, is it a simple infection, do they have allergies?” she notes. “And you can’t even get the prescription out – it won’t even print out, it won’t go into the system – unless you check all of the boxes. But we don’t do that here. We don’t have that type of system right now.”

Ms. Brummert says such a system might have prevented the harm from taking Levaquin her doctor prescribed for a suspected sinus infection in 2006.

Soon after she began taking the antibiotic, she ruptured her Achilles tendon, requiring surgery. By 2009, she’d had three ruptures, each needing surgical fixes. To date, she’s had more than 30 surgeries to correct tendon ruptures. She’s also had seizures, blood pressure issues, depression, chronic pain, and memory problems she attributes to taking Levaquin.

As it turns out, her doctor misdiagnosed her condition – a misstep that would have been averted with a system like Australia’s, which requires doctors to verify the presence of a bacterial infection through a simple test before prescribing a fluoroquinolone.

“When I got the Levaquin, it was for a suspected sinus infection that it turned out I didn’t even have in the first place,” she notes. “So, I took the Levaquin basically for nothing. But what I would have asked my doctor had I known is: ‘Why should I take something so strong for so simple an infection?’

“It seems common sense to me now that you don’t prescribe something that can kill anthrax for a simple sinus infection. It’s like an atom bomb killing a mosquito. I agree that there are uses for these drugs, but they are being overprescribed. And so, here I am 16 years later – I’m still rupturing, I’m still having surgery, and I’m still in pain – all for something I didn’t even need medicine for in the first place.”
 

Should guidelines be stronger?

So, why are so many doctors continuing to prescribe fluoroquinolones for simple infections? Dr. Adalja and other experts say several things are at work.

For one thing, Dr. Adalja notes, fluoroquinolones are broad-spectrum antibiotics that are effective against dangerous germs, including “gram-negative” bacterial infections, and are “100% bioavailable.” That means they are as effective when given in pill form as they are if put directly into a vein. So they can be used in an outpatient setting or to allow a patient to be discharged from a hospital sooner because they don’t need an IV to receive treatment.

“There are still some uses for these drugs because they are so bioavailable, and I think that drives some of the use, and those are legitimate uses, knowing that there are risks when you do it,” he says. “But no drug is without risks, and you have to weigh risks and benefits – that’s what medicine is about: deciding what the best drug is for a patient.”

But Dr. Adalja says the overprescription of fluoroquinolones is part of the larger trend of antibiotic overuse. That is driving up antibiotic resistance, which in turn is another thing leading doctors to turn to Cipro and other fluoroquinolones after other drugs have proven ineffective.

“You can’t separate this from the fact that 80% of antibiotic prescriptions in the outpatient setting are probably illegitimate or not warranted,” he notes. “And because fluoroquinolones are highly effective drugs against certain pathogens, they are the go-to [drug] for many people who are prescribing antibiotics.”

That’s why patients should be wary whenever a doctor prescribes a fluoroquinolone, or any drug to treat a suspected infection, he says.

“Any time a patient is getting prescribed an antibiotic by a physician, they should ask: ‘Do I really need this antibiotic?’ That should be the first question they ask,” he advises. “And if they’re getting a fluoroquinolone, they may want to ask: ‘Is this the best antibiotic for me?’ ”
 

What you can do

Ms. Brummert and Ms. Moser say they are sharing their stories to raise awareness of the dangers of fluoroquinolones.

Ms. Moser has published a book on her experiences, “The Magnificent Story of a Lame Author,” and provides a wealth of consumer resources on her blog: Mountains and Mustard Seeds.

“As much as I hate what has happened to me, it has put me in a place where I am glad that I can inform other patients,” she says.

Ms. Brummert supplements her advocacy work as an FDA adviser with useful materials she provides on her website: Drugwatch.com.

“Pain into purpose – that’s what I call it,” she says. “I can’t change what happened to me, but I can warn others.”

The upshot for patients?

• the FDA’s Drug Safety Communication on Fluoroquinolones online to learn more about the risks and benefits of these powerful antibiotics.
• If you believe you’ve been harmed by fluoroquinolones, MedWatch website to report your experiences.

Ms. Brummert also advises patients to ask 12 critical questions of any doctor who wants to prescribe a fluoroquinolone, including the following listed on her website:

• For what condition is this medication prescribed, and is there another drug specific to my condition?
• What are the risks associated with this medication, and do the benefits outweigh them?
• Will this medication interact with my other drugs and/or other health conditions?
• What are the “boxed” warnings for this medication, and where can I report adverse events?

“I would also do my own research,” she says. “I wouldn’t just take a prescription from a physician and just say, ‘OK, doctor knows best.’ ”

Ms. Moser agrees that you have to be your own patient advocate and not simply take a doctor’s advice on any medical issue without having a deeper conversation.

“I’ve had arguments with doctors who legitimately did not believe me when I told them what happened to me,” she says. “And I actually told them, ‘Go get your Physicians’ Desk Reference [for prescription drugs]’ and they opened the book in front of me and read the warnings. Obviously, they had not been keeping up with the added warnings. So, I do think that doctors do need to be better informed.”

“So, yes, it’s the FDA’s responsibility, but it is also the doctors’ responsibility to make sure that they’re watching out for the side effects and they’re reporting them when their patients come up with them and making those connections.”

A version of this article first appeared on WebMD.com.

When Amy Moser had a simple urinary tract infection in her late 20s, her doctor prescribed Cipro, a powerful antibiotic used to treat anthrax and some of the most fearsome bacterial infections.

Nearly 2 weeks after she finished her treatment, her left kneecap dislocated while she was trying on a swimsuit at a retail store. Shortly afterward, she had painful ligament ruptures in her wrists, then her shoulder dislocated, followed by three Achilles tendon tears.

“That’s when I fell apart,” says Ms. Moser, a Phoenix health blogger and book author. “From that moment on, for almost the next 2.5 years consistently, I had new tendon tears every few weeks.”

Ms. Moser’s doctors had no answer for what was causing her injuries, all of which required surgical fixes. A married mother of three, she was otherwise healthy and fit. So, after her third Achilles tear, she turned to the FDA’s website for answers. There, she found many warnings about side effects of Cipro, Levaquin, and other so-called fluoroquinolones, including risks for tendon and ligament injuries.

“When all the ruptures started to happen, my doctor kept asking me if I’d ever taken Levaquin, and every time I was like, ‘No.’ So I did what all doctors don’t want you to do: I Googled ‘Levaquin,’ ” she recalls.

Her search led to FDA warnings and articles about the possibility of tendon and ligament ruptures with fluroquinolones.

“That was the first time I’d ever even heard that word ‘fluroquinolones,’ and I found Cipro on that list ... and I realized that I’d just been prescribed that before everything started,” she says.

That was 12 years ago. Since then, the FDA has issued more warnings about fluoroquinolone risks. In that time, Ms. Moser, now 40, has had more than 30 surgeries to correct tendon ruptures and injuries, including a double-knee replacement this year.

“I am in chronic pain all the time,” she says. “I am chronically injured. I have a lot of tears that I’ve not fixed because they’re very complicated, and I don’t know if the rest of my body can handle the strain of recovering from those surgeries.”

Ms. Moser’s is hardly an isolated case. Since the 1980s, more than 60,000 patients have reported hundreds of thousands of serious events linked to fluoroquinolones to the FDA, including 6,575 reports of deaths.

The most common side effects were tendon rupture, as well as neurological and psychiatric symptoms. But experts estimate only 1%-10% of such events are reported to the FDA. That suggests that fluoroquinolones might have harmed hundreds of thousands of people in the United States alone, says Charles Bennett, MD, a hematologist at the University of South Carolina’s College of Pharmacy, Columbia.

Yet despite the many patient reports and FDA warnings on dangerous side effects, many doctors continue to wrongly prescribe fluoroquinolones for simple urinary tract infections, sinus infections, and respiratory issues better treated with less risky antibiotics.

“There probably is overprescription by primary care doctors for urinary tract infections and respiratory infections, when there could be alternatives that are safer to use,” says Amesh Adalja, MD, an infectious disease specialist and senior scholar with the Johns Hopkins Center for Health Security.

“I would say that’s probably the case in the outpatient setting, not necessarily in the hospital setting or among infectious disease doctors ... but I think it’s important to say there are still some judicious uses of fluoroquinolones,” he says. “However, there probably is a lot of injudicious use of fluoroquinolones along with many other antibiotics in the primary care setting.”
 

FDA warnings on fluoroquinolones

Fluoroquinolones are a class of broad-spectrum antibiotics used for decades to treat certain bacterial infections.

FDA-approved fluoroquinolones include ciprofloxacin (Cipro), ciprofloxacin extended-release tablets, delafloxacin (Baxdela), gemifloxacin (Factive) levofloxacin (Levaquin), moxifloxacin (Avelox), and ofloxacin (Floxin). More than 60 generic versions of these brand-name medicines are also on the market, making them among the most prescribed antibiotics in the U.S.

Over the past 2 decades, a wide range of physical and mental health side effects have been tied to fluoroquinolones. As a result of these “adverse event reports” and research published in medical literature, the FDA has required an escalating series of warnings and safety labeling changes for doctors who prescribe these drugs.

• In 2008, the FDA first added a “black box” warning to fluoroquinolones, citing an increased risk of tendinitis and tendon rupture in patients prescribed these meds.
• In 2011, the agency required the warning label to include risks of worsening symptoms for those with myasthenia gravis, a chronic autoimmune disease that causes muscle weakness, vision problems, and speech problems.
• In 2013, regulators required updated labels noting the potential for irreversible peripheral neuropathy (serious nerve damage).
• In 2016, the FDA issued its strongest warning against the use of such antibiotics for simple bacterial infections – such as uncomplicated urinary tract infections (UTIs), acute sinusitis, and acute bronchitis – saying the “association of fluoroquinolones with disabling and potentially permanent side effects involving tendons, muscles, joints, nerves and the central nervous system ... outweighs the benefits for patients.”
• And in 2018, regulators required safety labeling changes to include warnings about the risks of aortic aneurysm – a life-threatening enlargement of the main vessel that delivers blood to the body – as well as mental health side effects and serious blood sugar disturbances.

But FDA regulators have stopped short of barring fluoroquinolone use in the treatment of bacterial infections, citing the benefits for certain conditions.

“For some patients, the benefits of fluoroquinolones may continue to outweigh the risks for treatment of serious bacterial infections, such as pneumonia or intra-abdominal infections,” said former FDA Commissioner Scott Gottlieb, MD, “but there are other serious, known risks associated with these strong antibiotics that must be carefully weighed when considering their use.”

In December 2021, a study published in the journal JAMA Network Open found the FDA’s warnings may have helped lower prescribing of the drugs in Medicare patients. But not all doctors have been responsive to those warnings, researchers found.

“An overall decline in change over time and an immediate change in fluoroquinolone prescribing was observed after the 2016 FDA warning,” the authors concluded. “Certain physicians, such as primary care physicians, were more responsive to FDA warnings than others. ... Findings of this study suggest that identifying the association of physician and organizational characteristics with fluoroquinolone prescribing practices could help in developing mechanisms for improving de-adoption.”

Some critics say the FDA should do more to spotlight the dangers of fluoroquinolones and require doctors and patients to sign checklist consent forms to show they are aware of the potential side effects of these drugs.

Rachel Brummert, a patient advocate who sits on an FDA consumer advisory board, believes the FDA needs to improve its communication to doctors on fluoroquinolone risks and get tougher with those who continue to inappropriately prescribe the drugs.

“I think there needs to be a system in place, where if something comes down from the FDA about a drug, the physician has to sign off on it, the patient has to sign off on it and mark that they understand that there are these ‘black box’ warnings,” says Ms. Brummert, 52, a representative on the FDA’s Medical Devices Advisory Committee.

As an example, she points to Australia’s medical laws requiring doctors and patients to sign a checklist before any fluoroquinolone prescription is approved.

“When a physician prescribes a fluoroquinolone antibiotic, there’s a checklist – does the patient have an infection, is it a simple infection, do they have allergies?” she notes. “And you can’t even get the prescription out – it won’t even print out, it won’t go into the system – unless you check all of the boxes. But we don’t do that here. We don’t have that type of system right now.”

Ms. Brummert says such a system might have prevented the harm from taking Levaquin her doctor prescribed for a suspected sinus infection in 2006.

Soon after she began taking the antibiotic, she ruptured her Achilles tendon, requiring surgery. By 2009, she’d had three ruptures, each needing surgical fixes. To date, she’s had more than 30 surgeries to correct tendon ruptures. She’s also had seizures, blood pressure issues, depression, chronic pain, and memory problems she attributes to taking Levaquin.

As it turns out, her doctor misdiagnosed her condition – a misstep that would have been averted with a system like Australia’s, which requires doctors to verify the presence of a bacterial infection through a simple test before prescribing a fluoroquinolone.

“When I got the Levaquin, it was for a suspected sinus infection that it turned out I didn’t even have in the first place,” she notes. “So, I took the Levaquin basically for nothing. But what I would have asked my doctor had I known is: ‘Why should I take something so strong for so simple an infection?’

“It seems common sense to me now that you don’t prescribe something that can kill anthrax for a simple sinus infection. It’s like an atom bomb killing a mosquito. I agree that there are uses for these drugs, but they are being overprescribed. And so, here I am 16 years later – I’m still rupturing, I’m still having surgery, and I’m still in pain – all for something I didn’t even need medicine for in the first place.”
 

Should guidelines be stronger?

So, why are so many doctors continuing to prescribe fluoroquinolones for simple infections? Dr. Adalja and other experts say several things are at work.

For one thing, Dr. Adalja notes, fluoroquinolones are broad-spectrum antibiotics that are effective against dangerous germs, including “gram-negative” bacterial infections, and are “100% bioavailable.” That means they are as effective when given in pill form as they are if put directly into a vein. So they can be used in an outpatient setting or to allow a patient to be discharged from a hospital sooner because they don’t need an IV to receive treatment.

“There are still some uses for these drugs because they are so bioavailable, and I think that drives some of the use, and those are legitimate uses, knowing that there are risks when you do it,” he says. “But no drug is without risks, and you have to weigh risks and benefits – that’s what medicine is about: deciding what the best drug is for a patient.”

But Dr. Adalja says the overprescription of fluoroquinolones is part of the larger trend of antibiotic overuse. That is driving up antibiotic resistance, which in turn is another thing leading doctors to turn to Cipro and other fluoroquinolones after other drugs have proven ineffective.

“You can’t separate this from the fact that 80% of antibiotic prescriptions in the outpatient setting are probably illegitimate or not warranted,” he notes. “And because fluoroquinolones are highly effective drugs against certain pathogens, they are the go-to [drug] for many people who are prescribing antibiotics.”

That’s why patients should be wary whenever a doctor prescribes a fluoroquinolone, or any drug to treat a suspected infection, he says.

“Any time a patient is getting prescribed an antibiotic by a physician, they should ask: ‘Do I really need this antibiotic?’ That should be the first question they ask,” he advises. “And if they’re getting a fluoroquinolone, they may want to ask: ‘Is this the best antibiotic for me?’ ”
 

What you can do

Ms. Brummert and Ms. Moser say they are sharing their stories to raise awareness of the dangers of fluoroquinolones.

Ms. Moser has published a book on her experiences, “The Magnificent Story of a Lame Author,” and provides a wealth of consumer resources on her blog: Mountains and Mustard Seeds.

“As much as I hate what has happened to me, it has put me in a place where I am glad that I can inform other patients,” she says.

Ms. Brummert supplements her advocacy work as an FDA adviser with useful materials she provides on her website: Drugwatch.com.

“Pain into purpose – that’s what I call it,” she says. “I can’t change what happened to me, but I can warn others.”

The upshot for patients?

• the FDA’s Drug Safety Communication on Fluoroquinolones online to learn more about the risks and benefits of these powerful antibiotics.
• If you believe you’ve been harmed by fluoroquinolones, MedWatch website to report your experiences.

Ms. Brummert also advises patients to ask 12 critical questions of any doctor who wants to prescribe a fluoroquinolone, including the following listed on her website:

• For what condition is this medication prescribed, and is there another drug specific to my condition?
• What are the risks associated with this medication, and do the benefits outweigh them?
• Will this medication interact with my other drugs and/or other health conditions?
• What are the “boxed” warnings for this medication, and where can I report adverse events?

“I would also do my own research,” she says. “I wouldn’t just take a prescription from a physician and just say, ‘OK, doctor knows best.’ ”

Ms. Moser agrees that you have to be your own patient advocate and not simply take a doctor’s advice on any medical issue without having a deeper conversation.

“I’ve had arguments with doctors who legitimately did not believe me when I told them what happened to me,” she says. “And I actually told them, ‘Go get your Physicians’ Desk Reference [for prescription drugs]’ and they opened the book in front of me and read the warnings. Obviously, they had not been keeping up with the added warnings. So, I do think that doctors do need to be better informed.”

“So, yes, it’s the FDA’s responsibility, but it is also the doctors’ responsibility to make sure that they’re watching out for the side effects and they’re reporting them when their patients come up with them and making those connections.”

A version of this article first appeared on WebMD.com.

When Amy Moser had a simple urinary tract infection in her late 20s, her doctor prescribed Cipro, a powerful antibiotic used to treat anthrax and some of the most fearsome bacterial infections.

Nearly 2 weeks after she finished her treatment, her left kneecap dislocated while she was trying on a swimsuit at a retail store. Shortly afterward, she had painful ligament ruptures in her wrists, then her shoulder dislocated, followed by three Achilles tendon tears.

“That’s when I fell apart,” says Ms. Moser, a Phoenix health blogger and book author. “From that moment on, for almost the next 2.5 years consistently, I had new tendon tears every few weeks.”

Ms. Moser’s doctors had no answer for what was causing her injuries, all of which required surgical fixes. A married mother of three, she was otherwise healthy and fit. So, after her third Achilles tear, she turned to the FDA’s website for answers. There, she found many warnings about side effects of Cipro, Levaquin, and other so-called fluoroquinolones, including risks for tendon and ligament injuries.

“When all the ruptures started to happen, my doctor kept asking me if I’d ever taken Levaquin, and every time I was like, ‘No.’ So I did what all doctors don’t want you to do: I Googled ‘Levaquin,’ ” she recalls.

Her search led to FDA warnings and articles about the possibility of tendon and ligament ruptures with fluroquinolones.

“That was the first time I’d ever even heard that word ‘fluroquinolones,’ and I found Cipro on that list ... and I realized that I’d just been prescribed that before everything started,” she says.

That was 12 years ago. Since then, the FDA has issued more warnings about fluoroquinolone risks. In that time, Ms. Moser, now 40, has had more than 30 surgeries to correct tendon ruptures and injuries, including a double-knee replacement this year.

“I am in chronic pain all the time,” she says. “I am chronically injured. I have a lot of tears that I’ve not fixed because they’re very complicated, and I don’t know if the rest of my body can handle the strain of recovering from those surgeries.”

Ms. Moser’s is hardly an isolated case. Since the 1980s, more than 60,000 patients have reported hundreds of thousands of serious events linked to fluoroquinolones to the FDA, including 6,575 reports of deaths.

The most common side effects were tendon rupture, as well as neurological and psychiatric symptoms. But experts estimate only 1%-10% of such events are reported to the FDA. That suggests that fluoroquinolones might have harmed hundreds of thousands of people in the United States alone, says Charles Bennett, MD, a hematologist at the University of South Carolina’s College of Pharmacy, Columbia.

Yet despite the many patient reports and FDA warnings on dangerous side effects, many doctors continue to wrongly prescribe fluoroquinolones for simple urinary tract infections, sinus infections, and respiratory issues better treated with less risky antibiotics.

“There probably is overprescription by primary care doctors for urinary tract infections and respiratory infections, when there could be alternatives that are safer to use,” says Amesh Adalja, MD, an infectious disease specialist and senior scholar with the Johns Hopkins Center for Health Security.

“I would say that’s probably the case in the outpatient setting, not necessarily in the hospital setting or among infectious disease doctors ... but I think it’s important to say there are still some judicious uses of fluoroquinolones,” he says. “However, there probably is a lot of injudicious use of fluoroquinolones along with many other antibiotics in the primary care setting.”
 

FDA warnings on fluoroquinolones

Fluoroquinolones are a class of broad-spectrum antibiotics used for decades to treat certain bacterial infections.

FDA-approved fluoroquinolones include ciprofloxacin (Cipro), ciprofloxacin extended-release tablets, delafloxacin (Baxdela), gemifloxacin (Factive) levofloxacin (Levaquin), moxifloxacin (Avelox), and ofloxacin (Floxin). More than 60 generic versions of these brand-name medicines are also on the market, making them among the most prescribed antibiotics in the U.S.

Over the past 2 decades, a wide range of physical and mental health side effects have been tied to fluoroquinolones. As a result of these “adverse event reports” and research published in medical literature, the FDA has required an escalating series of warnings and safety labeling changes for doctors who prescribe these drugs.

• In 2008, the FDA first added a “black box” warning to fluoroquinolones, citing an increased risk of tendinitis and tendon rupture in patients prescribed these meds.
• In 2011, the agency required the warning label to include risks of worsening symptoms for those with myasthenia gravis, a chronic autoimmune disease that causes muscle weakness, vision problems, and speech problems.
• In 2013, regulators required updated labels noting the potential for irreversible peripheral neuropathy (serious nerve damage).
• In 2016, the FDA issued its strongest warning against the use of such antibiotics for simple bacterial infections – such as uncomplicated urinary tract infections (UTIs), acute sinusitis, and acute bronchitis – saying the “association of fluoroquinolones with disabling and potentially permanent side effects involving tendons, muscles, joints, nerves and the central nervous system ... outweighs the benefits for patients.”
• And in 2018, regulators required safety labeling changes to include warnings about the risks of aortic aneurysm – a life-threatening enlargement of the main vessel that delivers blood to the body – as well as mental health side effects and serious blood sugar disturbances.

But FDA regulators have stopped short of barring fluoroquinolone use in the treatment of bacterial infections, citing the benefits for certain conditions.

“For some patients, the benefits of fluoroquinolones may continue to outweigh the risks for treatment of serious bacterial infections, such as pneumonia or intra-abdominal infections,” said former FDA Commissioner Scott Gottlieb, MD, “but there are other serious, known risks associated with these strong antibiotics that must be carefully weighed when considering their use.”

In December 2021, a study published in the journal JAMA Network Open found the FDA’s warnings may have helped lower prescribing of the drugs in Medicare patients. But not all doctors have been responsive to those warnings, researchers found.

“An overall decline in change over time and an immediate change in fluoroquinolone prescribing was observed after the 2016 FDA warning,” the authors concluded. “Certain physicians, such as primary care physicians, were more responsive to FDA warnings than others. ... Findings of this study suggest that identifying the association of physician and organizational characteristics with fluoroquinolone prescribing practices could help in developing mechanisms for improving de-adoption.”

Some critics say the FDA should do more to spotlight the dangers of fluoroquinolones and require doctors and patients to sign checklist consent forms to show they are aware of the potential side effects of these drugs.

Rachel Brummert, a patient advocate who sits on an FDA consumer advisory board, believes the FDA needs to improve its communication to doctors on fluoroquinolone risks and get tougher with those who continue to inappropriately prescribe the drugs.

“I think there needs to be a system in place, where if something comes down from the FDA about a drug, the physician has to sign off on it, the patient has to sign off on it and mark that they understand that there are these ‘black box’ warnings,” says Ms. Brummert, 52, a representative on the FDA’s Medical Devices Advisory Committee.

As an example, she points to Australia’s medical laws requiring doctors and patients to sign a checklist before any fluoroquinolone prescription is approved.

“When a physician prescribes a fluoroquinolone antibiotic, there’s a checklist – does the patient have an infection, is it a simple infection, do they have allergies?” she notes. “And you can’t even get the prescription out – it won’t even print out, it won’t go into the system – unless you check all of the boxes. But we don’t do that here. We don’t have that type of system right now.”

Ms. Brummert says such a system might have prevented the harm from taking Levaquin her doctor prescribed for a suspected sinus infection in 2006.

Soon after she began taking the antibiotic, she ruptured her Achilles tendon, requiring surgery. By 2009, she’d had three ruptures, each needing surgical fixes. To date, she’s had more than 30 surgeries to correct tendon ruptures. She’s also had seizures, blood pressure issues, depression, chronic pain, and memory problems she attributes to taking Levaquin.

As it turns out, her doctor misdiagnosed her condition – a misstep that would have been averted with a system like Australia’s, which requires doctors to verify the presence of a bacterial infection through a simple test before prescribing a fluoroquinolone.

“When I got the Levaquin, it was for a suspected sinus infection that it turned out I didn’t even have in the first place,” she notes. “So, I took the Levaquin basically for nothing. But what I would have asked my doctor had I known is: ‘Why should I take something so strong for so simple an infection?’

“It seems common sense to me now that you don’t prescribe something that can kill anthrax for a simple sinus infection. It’s like an atom bomb killing a mosquito. I agree that there are uses for these drugs, but they are being overprescribed. And so, here I am 16 years later – I’m still rupturing, I’m still having surgery, and I’m still in pain – all for something I didn’t even need medicine for in the first place.”
 

Should guidelines be stronger?

So, why are so many doctors continuing to prescribe fluoroquinolones for simple infections? Dr. Adalja and other experts say several things are at work.

For one thing, Dr. Adalja notes, fluoroquinolones are broad-spectrum antibiotics that are effective against dangerous germs, including “gram-negative” bacterial infections, and are “100% bioavailable.” That means they are as effective when given in pill form as they are if put directly into a vein. So they can be used in an outpatient setting or to allow a patient to be discharged from a hospital sooner because they don’t need an IV to receive treatment.

“There are still some uses for these drugs because they are so bioavailable, and I think that drives some of the use, and those are legitimate uses, knowing that there are risks when you do it,” he says. “But no drug is without risks, and you have to weigh risks and benefits – that’s what medicine is about: deciding what the best drug is for a patient.”

But Dr. Adalja says the overprescription of fluoroquinolones is part of the larger trend of antibiotic overuse. That is driving up antibiotic resistance, which in turn is another thing leading doctors to turn to Cipro and other fluoroquinolones after other drugs have proven ineffective.

“You can’t separate this from the fact that 80% of antibiotic prescriptions in the outpatient setting are probably illegitimate or not warranted,” he notes. “And because fluoroquinolones are highly effective drugs against certain pathogens, they are the go-to [drug] for many people who are prescribing antibiotics.”

That’s why patients should be wary whenever a doctor prescribes a fluoroquinolone, or any drug to treat a suspected infection, he says.

“Any time a patient is getting prescribed an antibiotic by a physician, they should ask: ‘Do I really need this antibiotic?’ That should be the first question they ask,” he advises. “And if they’re getting a fluoroquinolone, they may want to ask: ‘Is this the best antibiotic for me?’ ”
 

What you can do

Ms. Brummert and Ms. Moser say they are sharing their stories to raise awareness of the dangers of fluoroquinolones.

Ms. Moser has published a book on her experiences, “The Magnificent Story of a Lame Author,” and provides a wealth of consumer resources on her blog: Mountains and Mustard Seeds.

“As much as I hate what has happened to me, it has put me in a place where I am glad that I can inform other patients,” she says.

Ms. Brummert supplements her advocacy work as an FDA adviser with useful materials she provides on her website: Drugwatch.com.

“Pain into purpose – that’s what I call it,” she says. “I can’t change what happened to me, but I can warn others.”

The upshot for patients?

• the FDA’s Drug Safety Communication on Fluoroquinolones online to learn more about the risks and benefits of these powerful antibiotics.
• If you believe you’ve been harmed by fluoroquinolones, MedWatch website to report your experiences.

Ms. Brummert also advises patients to ask 12 critical questions of any doctor who wants to prescribe a fluoroquinolone, including the following listed on her website:

• For what condition is this medication prescribed, and is there another drug specific to my condition?
• What are the risks associated with this medication, and do the benefits outweigh them?
• Will this medication interact with my other drugs and/or other health conditions?
• What are the “boxed” warnings for this medication, and where can I report adverse events?

“I would also do my own research,” she says. “I wouldn’t just take a prescription from a physician and just say, ‘OK, doctor knows best.’ ”

Ms. Moser agrees that you have to be your own patient advocate and not simply take a doctor’s advice on any medical issue without having a deeper conversation.

“I’ve had arguments with doctors who legitimately did not believe me when I told them what happened to me,” she says. “And I actually told them, ‘Go get your Physicians’ Desk Reference [for prescription drugs]’ and they opened the book in front of me and read the warnings. Obviously, they had not been keeping up with the added warnings. So, I do think that doctors do need to be better informed.”

“So, yes, it’s the FDA’s responsibility, but it is also the doctors’ responsibility to make sure that they’re watching out for the side effects and they’re reporting them when their patients come up with them and making those connections.”

A version of this article first appeared on WebMD.com.

Every time Nathan Chomilo, MD, uses a clinical decision support tool, he tells his patients they have a choice: He can input their race or keep that field blank.

Until recently, many clinicians didn’t question the use of race as a datapoint in tools used to make decisions about diagnosis and care. But that is changing.

“I’ve almost universally had patients appreciate that someone actually told them that their kidney function was being scored differently because of the color of their skin or how they were identified in the medical chart along lines of race,” Dr. Chomilo, an adjunct assistant professor of pediatrics at the University of Minnesota Medical School, Minneapolis, said.

Dr. Chomilo is referring to the estimated glomerular filtration rate (eGFR), which combines results from a blood test with factors such as age, sex, and race to calculate kidney function.

The eGFR weighed an input of “African American” as automatically indicating a higher concentration of serum creatinine than a non African American patient on the basis of the unsubstantiated idea that Black people have more creatinine in their blood at baseline.

The calculator creates a picture of a Black patient who is not as sick as a White patient with the same levels of kidney failure. But race is based on the color of a patient’s skin, not on genetics or other clinical datapoints.

“I often use my own example of being a biracial Black man: My father’s family is from Cameroon, my mother’s family is from Norway. Are you going to assign my kidneys or my lungs to my mom’s side or my dad’s side? That’s not clear at all in the way we use race in medicine,” Dr. Chomilo, an executive committee member on the section on minority health equity and inclusion at the American Academy of Pediatrics (AAP), said.

Long before the COVID-19 pandemic so publicly exposed the depths of inequality in morbidity and mortality in the United States, health advocates had been pointing out these disparities in tools used by medical professionals. But efforts to recognize that race is a poor proxy for genetics is in its infancy.

In May, the AAP published a policy statement that kicked off its examination of clinical guidelines and policies that include race as a biological proxy. A committee for the society is combing through each guideline or calculator, evaluating the scientific basis for the use of race, and examining whether a stronger datapoint could be used instead.

The eGFR is perhaps the best example of a calculator that’s gone through the process: Health care stakeholders questioned the use of race, and investigators went back to study whether race was really a good datapoint. It wasn’t, and Dr. Chamilo’s hospital joined many others in retiring the calculator.

But the eGFR is one of countless clinical tools – from rudimentary algorithms to sophisticated machine-learning instruments – that change the course of care in part on the basis of race in the same way datapoints such as weight, age, and height are used to inform decisions about patient management. But unlike race, height, weight, and age can be objectively measured. A physician either makes a guess, or a patient enters their race on a form. And while that can be useful on a population level, race does not equal genetics or any other measurable datapoint.

In a study published in JAMA Pediatrics, researchers reviewed 414 clinical practice guidelines from sources such as PubMed and MetaLib.gov. Almost 1 in 6 guidelines included race in an inappropriate way, such as by conflating race as a biological risk factor or establishing testing or treatment thresholds using race.
 

Waiting for alternatives

The University of Maryland Medical System last year embarked on a project similar to the AAP initiative but within its own system. The first use of race to be eliminated was in the eGFR. The health system also recently removed the variable from a tool for diagnosing urinary tract infections (UTIs) in children younger than 2 years.

Part of that tool includes deciding to perform a catheterized urine test. If a doctor chose “White” as the race, the tool would recommend the test. If the doctor chose “Black,” the tool would recommend to not test. Joseph Wright, MD, MPH, chief health equity officer at University of Maryland Medical System, said this step in the tool is based on the unproven assumption that young Black children had a lower likelihood of UTIs than their White peers.

“We simply want folks to not by default lob race in as a decisionmaking point when we have, with a little bit more scientific diligence, the ability to include better clinical variables,” Dr. Wright, who is also an adjunct professor of health policy and management at the University of Maryland School of Public Health, College Park, said.

The developers of the UTI tool recently released a revised version that removes race in favor of two new medical datapoints: whether the patient has had a fever for over 48 hours, and whether the patient has previously had a UTI.

The process of re-examining tools, coming up with new datapoints, and implementing changes is not simple, according to Dr. Wright.

“This is just the baby step to fix the algorithms, because we’re all going to have to examine our own house, where these calculators live, whether it’s in a textbook, whether it’s in an electronic health record, and that’s the heavy lift,” he said. “All sources of clinical guidance have to be scrutinized, and it’s going to literally take years to unroot.”

Electronic medical record vendor Cerner said it generally revises its algorithms after medical societies make changes, then communicates those fixes to providers.

Rebecca C. Winokur, MD, MPH, lead physician executive and health equity service line leader at Cerner, explained that if doctors ordered an eGFR a year ago and then another today, the results might be different because of the new code that eliminates race.

“The numbers are so different, how do you know that the patient may or may not have the same function?” Dr. Winokur said.

Dr. Winokur said the company is trying to determine at which point a message should pop up in the records workflow that would inform clinicians that they may be comparing apples to cherries. The company also is reconsidering the use of race in tools that estimate the probability of a successful vaginal birth after prior cesarean delivery, a calculator that predicts the risk of urethral stones in patients with flank pain, and another that measures lung function to help diagnose pulmonary disease.

In addition to managing the logistics of removing race, health institutions also need buy-in from clinicians. At Mass General Brigham, Boston, Thomas Sequist, MD, MPH, chief medical officer, is leading a project to examine how the system uses race in calculators.

“People struggle mainly with, well, if we shouldn’t use this calculator, what should we use, because we need a calculator. And that’s a legitimate question,” Dr. Sequist said in an interview. “If we’re going to stop using this race-based calculator, I still need to know what dose of medication I give my patient. We’re not going to pull any of these calculators until we have a safe and reliable alternative.”

For each calculator, relevant specialty chiefs come to the table with Dr. Sequist and his team; current projects include examining bone density screenings and cardiac risk scores. A large part of the work is communicating the lack of science behind the inclusion of race as a variable.

“It’s hard because these tools have been in existence for decades, and people are used to using them,” Dr. Sequist said. “So this is a big-change management project.”

Some clinicians also have difficulty discerning why their health system may stratify patient outcomes by race while providers are being told that race is being removed from the calculators they use every day. The key difference is that stratifying outcomes by race illuminates systemic problems that can be targeted by a health system.

For instance, if readmission rates are higher for Black patients overall after surgery, the reason might be that nurses are not delivering the same level of care to them as they are to non-Black patients, possibly because of hidden bias. Or, perhaps Black patients at a hospital have less access to transportation for follow-up appointments after surgery. The potential reasons can be investigated, and solutions can be created.

“If you look at a population level, what you’re looking for is not for the evidence of race as a biological construct,” Dr. Chomilo said. “You’re looking for the impact of racism on populations, and that’s the difference: It’s racism, not race.”

A version of this article first appeared on Medscape.com.

Every time Nathan Chomilo, MD, uses a clinical decision support tool, he tells his patients they have a choice: He can input their race or keep that field blank.

Until recently, many clinicians didn’t question the use of race as a datapoint in tools used to make decisions about diagnosis and care. But that is changing.

“I’ve almost universally had patients appreciate that someone actually told them that their kidney function was being scored differently because of the color of their skin or how they were identified in the medical chart along lines of race,” Dr. Chomilo, an adjunct assistant professor of pediatrics at the University of Minnesota Medical School, Minneapolis, said.

Dr. Chomilo is referring to the estimated glomerular filtration rate (eGFR), which combines results from a blood test with factors such as age, sex, and race to calculate kidney function.

The eGFR weighed an input of “African American” as automatically indicating a higher concentration of serum creatinine than a non African American patient on the basis of the unsubstantiated idea that Black people have more creatinine in their blood at baseline.

The calculator creates a picture of a Black patient who is not as sick as a White patient with the same levels of kidney failure. But race is based on the color of a patient’s skin, not on genetics or other clinical datapoints.

“I often use my own example of being a biracial Black man: My father’s family is from Cameroon, my mother’s family is from Norway. Are you going to assign my kidneys or my lungs to my mom’s side or my dad’s side? That’s not clear at all in the way we use race in medicine,” Dr. Chomilo, an executive committee member on the section on minority health equity and inclusion at the American Academy of Pediatrics (AAP), said.

Long before the COVID-19 pandemic so publicly exposed the depths of inequality in morbidity and mortality in the United States, health advocates had been pointing out these disparities in tools used by medical professionals. But efforts to recognize that race is a poor proxy for genetics is in its infancy.

In May, the AAP published a policy statement that kicked off its examination of clinical guidelines and policies that include race as a biological proxy. A committee for the society is combing through each guideline or calculator, evaluating the scientific basis for the use of race, and examining whether a stronger datapoint could be used instead.

The eGFR is perhaps the best example of a calculator that’s gone through the process: Health care stakeholders questioned the use of race, and investigators went back to study whether race was really a good datapoint. It wasn’t, and Dr. Chamilo’s hospital joined many others in retiring the calculator.

But the eGFR is one of countless clinical tools – from rudimentary algorithms to sophisticated machine-learning instruments – that change the course of care in part on the basis of race in the same way datapoints such as weight, age, and height are used to inform decisions about patient management. But unlike race, height, weight, and age can be objectively measured. A physician either makes a guess, or a patient enters their race on a form. And while that can be useful on a population level, race does not equal genetics or any other measurable datapoint.

In a study published in JAMA Pediatrics, researchers reviewed 414 clinical practice guidelines from sources such as PubMed and MetaLib.gov. Almost 1 in 6 guidelines included race in an inappropriate way, such as by conflating race as a biological risk factor or establishing testing or treatment thresholds using race.
 

Waiting for alternatives

The University of Maryland Medical System last year embarked on a project similar to the AAP initiative but within its own system. The first use of race to be eliminated was in the eGFR. The health system also recently removed the variable from a tool for diagnosing urinary tract infections (UTIs) in children younger than 2 years.

Part of that tool includes deciding to perform a catheterized urine test. If a doctor chose “White” as the race, the tool would recommend the test. If the doctor chose “Black,” the tool would recommend to not test. Joseph Wright, MD, MPH, chief health equity officer at University of Maryland Medical System, said this step in the tool is based on the unproven assumption that young Black children had a lower likelihood of UTIs than their White peers.

“We simply want folks to not by default lob race in as a decisionmaking point when we have, with a little bit more scientific diligence, the ability to include better clinical variables,” Dr. Wright, who is also an adjunct professor of health policy and management at the University of Maryland School of Public Health, College Park, said.

The developers of the UTI tool recently released a revised version that removes race in favor of two new medical datapoints: whether the patient has had a fever for over 48 hours, and whether the patient has previously had a UTI.

The process of re-examining tools, coming up with new datapoints, and implementing changes is not simple, according to Dr. Wright.

“This is just the baby step to fix the algorithms, because we’re all going to have to examine our own house, where these calculators live, whether it’s in a textbook, whether it’s in an electronic health record, and that’s the heavy lift,” he said. “All sources of clinical guidance have to be scrutinized, and it’s going to literally take years to unroot.”

Electronic medical record vendor Cerner said it generally revises its algorithms after medical societies make changes, then communicates those fixes to providers.

Rebecca C. Winokur, MD, MPH, lead physician executive and health equity service line leader at Cerner, explained that if doctors ordered an eGFR a year ago and then another today, the results might be different because of the new code that eliminates race.

“The numbers are so different, how do you know that the patient may or may not have the same function?” Dr. Winokur said.

Dr. Winokur said the company is trying to determine at which point a message should pop up in the records workflow that would inform clinicians that they may be comparing apples to cherries. The company also is reconsidering the use of race in tools that estimate the probability of a successful vaginal birth after prior cesarean delivery, a calculator that predicts the risk of urethral stones in patients with flank pain, and another that measures lung function to help diagnose pulmonary disease.

In addition to managing the logistics of removing race, health institutions also need buy-in from clinicians. At Mass General Brigham, Boston, Thomas Sequist, MD, MPH, chief medical officer, is leading a project to examine how the system uses race in calculators.

“People struggle mainly with, well, if we shouldn’t use this calculator, what should we use, because we need a calculator. And that’s a legitimate question,” Dr. Sequist said in an interview. “If we’re going to stop using this race-based calculator, I still need to know what dose of medication I give my patient. We’re not going to pull any of these calculators until we have a safe and reliable alternative.”

For each calculator, relevant specialty chiefs come to the table with Dr. Sequist and his team; current projects include examining bone density screenings and cardiac risk scores. A large part of the work is communicating the lack of science behind the inclusion of race as a variable.

“It’s hard because these tools have been in existence for decades, and people are used to using them,” Dr. Sequist said. “So this is a big-change management project.”

Some clinicians also have difficulty discerning why their health system may stratify patient outcomes by race while providers are being told that race is being removed from the calculators they use every day. The key difference is that stratifying outcomes by race illuminates systemic problems that can be targeted by a health system.

For instance, if readmission rates are higher for Black patients overall after surgery, the reason might be that nurses are not delivering the same level of care to them as they are to non-Black patients, possibly because of hidden bias. Or, perhaps Black patients at a hospital have less access to transportation for follow-up appointments after surgery. The potential reasons can be investigated, and solutions can be created.

“If you look at a population level, what you’re looking for is not for the evidence of race as a biological construct,” Dr. Chomilo said. “You’re looking for the impact of racism on populations, and that’s the difference: It’s racism, not race.”

A version of this article first appeared on Medscape.com.

Every time Nathan Chomilo, MD, uses a clinical decision support tool, he tells his patients they have a choice: He can input their race or keep that field blank.

Until recently, many clinicians didn’t question the use of race as a datapoint in tools used to make decisions about diagnosis and care. But that is changing.

“I’ve almost universally had patients appreciate that someone actually told them that their kidney function was being scored differently because of the color of their skin or how they were identified in the medical chart along lines of race,” Dr. Chomilo, an adjunct assistant professor of pediatrics at the University of Minnesota Medical School, Minneapolis, said.

Dr. Chomilo is referring to the estimated glomerular filtration rate (eGFR), which combines results from a blood test with factors such as age, sex, and race to calculate kidney function.

The eGFR weighed an input of “African American” as automatically indicating a higher concentration of serum creatinine than a non African American patient on the basis of the unsubstantiated idea that Black people have more creatinine in their blood at baseline.

The calculator creates a picture of a Black patient who is not as sick as a White patient with the same levels of kidney failure. But race is based on the color of a patient’s skin, not on genetics or other clinical datapoints.

“I often use my own example of being a biracial Black man: My father’s family is from Cameroon, my mother’s family is from Norway. Are you going to assign my kidneys or my lungs to my mom’s side or my dad’s side? That’s not clear at all in the way we use race in medicine,” Dr. Chomilo, an executive committee member on the section on minority health equity and inclusion at the American Academy of Pediatrics (AAP), said.

Long before the COVID-19 pandemic so publicly exposed the depths of inequality in morbidity and mortality in the United States, health advocates had been pointing out these disparities in tools used by medical professionals. But efforts to recognize that race is a poor proxy for genetics is in its infancy.

In May, the AAP published a policy statement that kicked off its examination of clinical guidelines and policies that include race as a biological proxy. A committee for the society is combing through each guideline or calculator, evaluating the scientific basis for the use of race, and examining whether a stronger datapoint could be used instead.

The eGFR is perhaps the best example of a calculator that’s gone through the process: Health care stakeholders questioned the use of race, and investigators went back to study whether race was really a good datapoint. It wasn’t, and Dr. Chamilo’s hospital joined many others in retiring the calculator.

But the eGFR is one of countless clinical tools – from rudimentary algorithms to sophisticated machine-learning instruments – that change the course of care in part on the basis of race in the same way datapoints such as weight, age, and height are used to inform decisions about patient management. But unlike race, height, weight, and age can be objectively measured. A physician either makes a guess, or a patient enters their race on a form. And while that can be useful on a population level, race does not equal genetics or any other measurable datapoint.

In a study published in JAMA Pediatrics, researchers reviewed 414 clinical practice guidelines from sources such as PubMed and MetaLib.gov. Almost 1 in 6 guidelines included race in an inappropriate way, such as by conflating race as a biological risk factor or establishing testing or treatment thresholds using race.
 

Waiting for alternatives

The University of Maryland Medical System last year embarked on a project similar to the AAP initiative but within its own system. The first use of race to be eliminated was in the eGFR. The health system also recently removed the variable from a tool for diagnosing urinary tract infections (UTIs) in children younger than 2 years.

Part of that tool includes deciding to perform a catheterized urine test. If a doctor chose “White” as the race, the tool would recommend the test. If the doctor chose “Black,” the tool would recommend to not test. Joseph Wright, MD, MPH, chief health equity officer at University of Maryland Medical System, said this step in the tool is based on the unproven assumption that young Black children had a lower likelihood of UTIs than their White peers.

“We simply want folks to not by default lob race in as a decisionmaking point when we have, with a little bit more scientific diligence, the ability to include better clinical variables,” Dr. Wright, who is also an adjunct professor of health policy and management at the University of Maryland School of Public Health, College Park, said.

The developers of the UTI tool recently released a revised version that removes race in favor of two new medical datapoints: whether the patient has had a fever for over 48 hours, and whether the patient has previously had a UTI.

The process of re-examining tools, coming up with new datapoints, and implementing changes is not simple, according to Dr. Wright.

“This is just the baby step to fix the algorithms, because we’re all going to have to examine our own house, where these calculators live, whether it’s in a textbook, whether it’s in an electronic health record, and that’s the heavy lift,” he said. “All sources of clinical guidance have to be scrutinized, and it’s going to literally take years to unroot.”

Electronic medical record vendor Cerner said it generally revises its algorithms after medical societies make changes, then communicates those fixes to providers.

Rebecca C. Winokur, MD, MPH, lead physician executive and health equity service line leader at Cerner, explained that if doctors ordered an eGFR a year ago and then another today, the results might be different because of the new code that eliminates race.

“The numbers are so different, how do you know that the patient may or may not have the same function?” Dr. Winokur said.

Dr. Winokur said the company is trying to determine at which point a message should pop up in the records workflow that would inform clinicians that they may be comparing apples to cherries. The company also is reconsidering the use of race in tools that estimate the probability of a successful vaginal birth after prior cesarean delivery, a calculator that predicts the risk of urethral stones in patients with flank pain, and another that measures lung function to help diagnose pulmonary disease.

In addition to managing the logistics of removing race, health institutions also need buy-in from clinicians. At Mass General Brigham, Boston, Thomas Sequist, MD, MPH, chief medical officer, is leading a project to examine how the system uses race in calculators.

“People struggle mainly with, well, if we shouldn’t use this calculator, what should we use, because we need a calculator. And that’s a legitimate question,” Dr. Sequist said in an interview. “If we’re going to stop using this race-based calculator, I still need to know what dose of medication I give my patient. We’re not going to pull any of these calculators until we have a safe and reliable alternative.”

For each calculator, relevant specialty chiefs come to the table with Dr. Sequist and his team; current projects include examining bone density screenings and cardiac risk scores. A large part of the work is communicating the lack of science behind the inclusion of race as a variable.

“It’s hard because these tools have been in existence for decades, and people are used to using them,” Dr. Sequist said. “So this is a big-change management project.”

Some clinicians also have difficulty discerning why their health system may stratify patient outcomes by race while providers are being told that race is being removed from the calculators they use every day. The key difference is that stratifying outcomes by race illuminates systemic problems that can be targeted by a health system.

For instance, if readmission rates are higher for Black patients overall after surgery, the reason might be that nurses are not delivering the same level of care to them as they are to non-Black patients, possibly because of hidden bias. Or, perhaps Black patients at a hospital have less access to transportation for follow-up appointments after surgery. The potential reasons can be investigated, and solutions can be created.

“If you look at a population level, what you’re looking for is not for the evidence of race as a biological construct,” Dr. Chomilo said. “You’re looking for the impact of racism on populations, and that’s the difference: It’s racism, not race.”

A version of this article first appeared on Medscape.com.

In an unprecedented year when income increased for all specialties, pediatricians did better than most, according to a recent survey by Medscape.

Pediatricians reported an average income of $244,000 for 2021, an increase of 10.4% over 2020 that was topped by only three of the 29+ specialties included in the poll. Medscape also noted that, for the first time in the 11 years it’s been conducting these physician compensation surveys, “all specialties have seen an increase in income.”

At least some of that positive news can be traced back to the reduced impact of COVID-19. “Compensation for most physicians is trending back up as demand for physicians accelerates. The market for physicians has done a complete 180 over just 7 or 8 months,” James Taylor of AMN Healthcare’s physician and leadership solutions division said in Medscape Pediatrician Compensation Report 2022.

The 10% increase in pediatricians’ income, however, was not enough to reach the average for primary care physicians, $260,000, which was up by 7.4% over 2020. It was enough, though, to move pediatricians from the bottom of the earnings-by-specialty list, where they were last year, to next-to-last this year (public health/preventive medicine, with average earnings of $243,000 in 2021, is not shown in the graph).

The gender gap in earnings left male pediatricians’ income 26% higher than their female counterparts, slightly above the gap of 25% for primary care physicians and 24% for all physicians. For specialists, the gap was 31% in favor of men, based on data from 13,064 Medscape member physicians who participated in the survey, which was conducted online from Oct. 5, 2021, to Jan. 19, 2022. For the record, 57% of the pediatricians who responded were women.

The gaps and low income averages were enough, it seems, to keep pediatricians fairly negative regarding their feelings on compensation. Only 47% think they were fairly compensated in 2021, higher only than diabetes/endocrinology and nephrology. Among the other primary care specialties, internal medicine and ob.gyn. were slightly higher at 49% and family medicine was 55% – still just middle of the pack, compared with public health/preventive medicine at 72%, Medscape said in the report.
 

Would you do it again?

Moving to the less-economic aspects of the survey, respondents also were asked if they would choose medicine again as a career. Once more pediatricians were low on the scale, as only 70% said that they would enter medicine again, down from 77% last year and lower than this year’s average of 73% average for all physicians.

When they were asked if they would choose pediatrics again as a specialty, the response was a bit more positive: 84% said yes. That middle-of-the-pack showing was well ahead of internal medicine (63%) and family medicine (68%), but well below dermatology (99%) and orthopedics (97%), which are “among the top groups in our survey year after year,” Medscape said.

Did the administrative challenges of medical practice have an effect on those answers? Pediatrician respondents said that they spend 14.9 hours per week on paperwork and administration, close to the average of 15.5 hours for all physicians. The internists, who are least likely to choose their original specialty again, spend 18.7 hours on paperwork each week, while dermatologists, the most likely to repeat their first choice, have just 11.9 hours of paperwork per week.

The exact number of pediatricians involved in the survey was not provided, but they made up about 8% of the total cohort, which works out to somewhere between 1,000 and 1,100 individuals. All respondents had to be practicing in the United States, and compensation was analyzed for full-time physicians only. The sampling error is ±0.86% at a 95% confidence level.

In an unprecedented year when income increased for all specialties, pediatricians did better than most, according to a recent survey by Medscape.

Pediatricians reported an average income of $244,000 for 2021, an increase of 10.4% over 2020 that was topped by only three of the 29+ specialties included in the poll. Medscape also noted that, for the first time in the 11 years it’s been conducting these physician compensation surveys, “all specialties have seen an increase in income.”

At least some of that positive news can be traced back to the reduced impact of COVID-19. “Compensation for most physicians is trending back up as demand for physicians accelerates. The market for physicians has done a complete 180 over just 7 or 8 months,” James Taylor of AMN Healthcare’s physician and leadership solutions division said in Medscape Pediatrician Compensation Report 2022.

The 10% increase in pediatricians’ income, however, was not enough to reach the average for primary care physicians, $260,000, which was up by 7.4% over 2020. It was enough, though, to move pediatricians from the bottom of the earnings-by-specialty list, where they were last year, to next-to-last this year (public health/preventive medicine, with average earnings of $243,000 in 2021, is not shown in the graph).

The gender gap in earnings left male pediatricians’ income 26% higher than their female counterparts, slightly above the gap of 25% for primary care physicians and 24% for all physicians. For specialists, the gap was 31% in favor of men, based on data from 13,064 Medscape member physicians who participated in the survey, which was conducted online from Oct. 5, 2021, to Jan. 19, 2022. For the record, 57% of the pediatricians who responded were women.

The gaps and low income averages were enough, it seems, to keep pediatricians fairly negative regarding their feelings on compensation. Only 47% think they were fairly compensated in 2021, higher only than diabetes/endocrinology and nephrology. Among the other primary care specialties, internal medicine and ob.gyn. were slightly higher at 49% and family medicine was 55% – still just middle of the pack, compared with public health/preventive medicine at 72%, Medscape said in the report.
 

Would you do it again?

Moving to the less-economic aspects of the survey, respondents also were asked if they would choose medicine again as a career. Once more pediatricians were low on the scale, as only 70% said that they would enter medicine again, down from 77% last year and lower than this year’s average of 73% average for all physicians.

When they were asked if they would choose pediatrics again as a specialty, the response was a bit more positive: 84% said yes. That middle-of-the-pack showing was well ahead of internal medicine (63%) and family medicine (68%), but well below dermatology (99%) and orthopedics (97%), which are “among the top groups in our survey year after year,” Medscape said.

Did the administrative challenges of medical practice have an effect on those answers? Pediatrician respondents said that they spend 14.9 hours per week on paperwork and administration, close to the average of 15.5 hours for all physicians. The internists, who are least likely to choose their original specialty again, spend 18.7 hours on paperwork each week, while dermatologists, the most likely to repeat their first choice, have just 11.9 hours of paperwork per week.

The exact number of pediatricians involved in the survey was not provided, but they made up about 8% of the total cohort, which works out to somewhere between 1,000 and 1,100 individuals. All respondents had to be practicing in the United States, and compensation was analyzed for full-time physicians only. The sampling error is ±0.86% at a 95% confidence level.

In an unprecedented year when income increased for all specialties, pediatricians did better than most, according to a recent survey by Medscape.

Pediatricians reported an average income of $244,000 for 2021, an increase of 10.4% over 2020 that was topped by only three of the 29+ specialties included in the poll. Medscape also noted that, for the first time in the 11 years it’s been conducting these physician compensation surveys, “all specialties have seen an increase in income.”

At least some of that positive news can be traced back to the reduced impact of COVID-19. “Compensation for most physicians is trending back up as demand for physicians accelerates. The market for physicians has done a complete 180 over just 7 or 8 months,” James Taylor of AMN Healthcare’s physician and leadership solutions division said in Medscape Pediatrician Compensation Report 2022.

The 10% increase in pediatricians’ income, however, was not enough to reach the average for primary care physicians, $260,000, which was up by 7.4% over 2020. It was enough, though, to move pediatricians from the bottom of the earnings-by-specialty list, where they were last year, to next-to-last this year (public health/preventive medicine, with average earnings of $243,000 in 2021, is not shown in the graph).

The gender gap in earnings left male pediatricians’ income 26% higher than their female counterparts, slightly above the gap of 25% for primary care physicians and 24% for all physicians. For specialists, the gap was 31% in favor of men, based on data from 13,064 Medscape member physicians who participated in the survey, which was conducted online from Oct. 5, 2021, to Jan. 19, 2022. For the record, 57% of the pediatricians who responded were women.

The gaps and low income averages were enough, it seems, to keep pediatricians fairly negative regarding their feelings on compensation. Only 47% think they were fairly compensated in 2021, higher only than diabetes/endocrinology and nephrology. Among the other primary care specialties, internal medicine and ob.gyn. were slightly higher at 49% and family medicine was 55% – still just middle of the pack, compared with public health/preventive medicine at 72%, Medscape said in the report.
 

Would you do it again?

Moving to the less-economic aspects of the survey, respondents also were asked if they would choose medicine again as a career. Once more pediatricians were low on the scale, as only 70% said that they would enter medicine again, down from 77% last year and lower than this year’s average of 73% average for all physicians.

When they were asked if they would choose pediatrics again as a specialty, the response was a bit more positive: 84% said yes. That middle-of-the-pack showing was well ahead of internal medicine (63%) and family medicine (68%), but well below dermatology (99%) and orthopedics (97%), which are “among the top groups in our survey year after year,” Medscape said.

Did the administrative challenges of medical practice have an effect on those answers? Pediatrician respondents said that they spend 14.9 hours per week on paperwork and administration, close to the average of 15.5 hours for all physicians. The internists, who are least likely to choose their original specialty again, spend 18.7 hours on paperwork each week, while dermatologists, the most likely to repeat their first choice, have just 11.9 hours of paperwork per week.

The exact number of pediatricians involved in the survey was not provided, but they made up about 8% of the total cohort, which works out to somewhere between 1,000 and 1,100 individuals. All respondents had to be practicing in the United States, and compensation was analyzed for full-time physicians only. The sampling error is ±0.86% at a 95% confidence level.

It is projected that by 2050, 1.6 billion women in the world will have reached menopause or the postmenopausal period, a significant increase, compared with a billion women in 2020. Of all menopausal women, around 75% are affected by troublesome menopause symptoms, such as hot flashes and night sweats.

Around 84% of postmenopausal women experience genitourinary symptoms, such as vulvovaginal atrophy and incontinence.

Menopausal hormone therapy (MHT) is the most effective treatment for managing these symptoms; however, its effects on numerous aspects of female health remain uncertain, in particular with regard to breast cancer. The influence of MHT on breast cancer remains unsettled, with discordant findings from observational studies and randomized clinical trials, a factor that affects the decisions made by doctors concerning hormone therapy in menopausal women.
 

Background

Conjugated equine estrogens (CEEs) were introduced into clinical practice in the 1940s. For decades, MHT was the main treatment in conventional medicine for the symptoms of menopause. MHT was used in Western countries for about 600 million women starting from 1970, and it progressively increased during the 1990s. Professional organizations recommended MHT for the prevention of osteoporosis and chronic heart disease (CHD), and a third of prescriptions were for women older than 60 years.

Against this background, the National Institutes of Health launched randomized trials of MHT through the Women’s Health Initiative (WHI) to test whether the association with reduced risk for CHD found in observational studies was real and to obtain reliable information on the overall risks and benefits regarding the prevention of chronic disease for postmenopausal women aged 50-79 years.

The WHI trials tested standard-dose oral CEEs with and without standard-dose continuous medroxyprogesterone acetate (EPT). In 2002, the results of the WHI studies raised a series of concerns about the long-term safety of MHT, in particular the finding of an increased risk of breast cancer for women undergoing therapy. That risk exceeded the benefits from reductions in hip fractures and colorectal cancer.

The WHI findings received wide attention. Prescriptions for MHT dropped precipitously after 2002 and continued to decline in subsequent years. Declines were most marked for standard-dose EPT and in older women. The results of the CEE study were less negative, compared with those for EPT, as they showed no effect on CHD, a nonsignificant reduction in the risk of breast cancer, and a more favorable risk-benefit ratio for younger women, compared with older women. A decade later, it had become widely accepted that MHT should not be used for the prevention of chronic disease in older women; however, short-term use for treatment of vasomotor symptoms remains an accepted indication.
 

Risks and outcomes

Emerging from a series of WHI reports are complex models on the effect of hormonal therapy on the risk and outcome of breast cancer. In one study, women with an intact uterus received CEEs plus medroxyprogesterone acetate (MPA). An increase in the risk of breast cancer was observed over a median of 5.6 years of treatment, followed by a moderate reduction, with the risk increasing after 13 years of cumulative follow-up. For women treated with CEE alone, the reduction in risk observed over an average of 7.2 years of treatment was maintained for 13 years of follow-up.

Results from observational studies contrast with those from randomized controlled trials, particularly those concerning the use of estrogens only. A meta-analysis by the Collaborative Group on Hormonal Factors in Breast Cancer showed that both EPT and CEE were associated with a higher risk of breast neoplasia. Results of the Million Women Study showed a higher death rate.
 

Treatment methods and duration

Information from prospective studies on the effects of commencing MHT at various ages between 40 and 59 years show that for women who commenced treatment at any time within this age range, the relative risk was similar and was highly significant for all ages. Few women had started MHT treatment well after menopause at ages 60-69 years, and their excess risks during years 5-14 of current use were significant for estrogen-progestogen but not for estrogen-only MHT.

If these associations are largely causal, then for women of average weight in developed countries, 5 years of MHT, starting at age 50 years, would increase breast cancer incidence at ages 50-69 years by about 1 in every 50 users of estrogen plus daily progestogen preparations; 1 in every 70 users of estrogen plus intermittent progestogen preparations; and 1 in every 200 users of estrogen-only preparations. The corresponding excesses from 10 years of MHT would be about twice as great.

During 5-14 years of MHT use, the RRs were similarly increased if MHT use had started at ages 40-44 years, 45-49 years, 50-54 years, and 55-59 years; RRs appeared to be attenuated if MHT use had started after age 60 years. They were also attenuated by adiposity, particularly for estrogen-only MHT (which had little effect in obese women). After MHT use ceased, some excess risk of breast cancer persisted for more than a decade; this is directly correlated with the duration of treatment.

Therefore, it can be expected that the effects of MHT may vary between participants on the basis of age or time since menopause, as well as treatments (MHT type, dose, formulation, duration of use, and route of administration). Regarding formulation effects on the risk of breast cancer, new evidence shows an increased risk of 28%. Progestogens appeared to be differentially associated with breast cancer (micronized progesterone: odds ratio, 0.99; 95% confidence interval 0.55-1.79; synthetic progestin: OR, 1.28; 95% CI, 1.22-1.35). When prescribing MHT, micronized progesterone may be the safer progestogen to use.

In conclusion, MHT has a complex balance of benefits and risk on various health outcomes. Some effects differ qualitatively between ET and EPT. Regarding use of MHT, consideration should be given to the full range of effects, along with patients’ values and preferences. The overall quality of existing systematic reviews is moderate to poor. Clinicians should evaluate their scientific strength before considering applying their results in clinical practice. Regarding use of any hormone therapy regimen, consideration should be given to the full range of risk and benefits and should involve shared decisionmaking with the patient. It should be recognized that risk-benefit balance is altered by factors such as age, time from menopause, oophorectomy status, and prior hysterectomy and that some outcomes persist and there is some attenuation after stopping use.

This article was translated from Univadis Italy.

A version of the article appeared on Medscape.com.

It is projected that by 2050, 1.6 billion women in the world will have reached menopause or the postmenopausal period, a significant increase, compared with a billion women in 2020. Of all menopausal women, around 75% are affected by troublesome menopause symptoms, such as hot flashes and night sweats.

Around 84% of postmenopausal women experience genitourinary symptoms, such as vulvovaginal atrophy and incontinence.

Menopausal hormone therapy (MHT) is the most effective treatment for managing these symptoms; however, its effects on numerous aspects of female health remain uncertain, in particular with regard to breast cancer. The influence of MHT on breast cancer remains unsettled, with discordant findings from observational studies and randomized clinical trials, a factor that affects the decisions made by doctors concerning hormone therapy in menopausal women.
 

Background

Conjugated equine estrogens (CEEs) were introduced into clinical practice in the 1940s. For decades, MHT was the main treatment in conventional medicine for the symptoms of menopause. MHT was used in Western countries for about 600 million women starting from 1970, and it progressively increased during the 1990s. Professional organizations recommended MHT for the prevention of osteoporosis and chronic heart disease (CHD), and a third of prescriptions were for women older than 60 years.

Against this background, the National Institutes of Health launched randomized trials of MHT through the Women’s Health Initiative (WHI) to test whether the association with reduced risk for CHD found in observational studies was real and to obtain reliable information on the overall risks and benefits regarding the prevention of chronic disease for postmenopausal women aged 50-79 years.

The WHI trials tested standard-dose oral CEEs with and without standard-dose continuous medroxyprogesterone acetate (EPT). In 2002, the results of the WHI studies raised a series of concerns about the long-term safety of MHT, in particular the finding of an increased risk of breast cancer for women undergoing therapy. That risk exceeded the benefits from reductions in hip fractures and colorectal cancer.

The WHI findings received wide attention. Prescriptions for MHT dropped precipitously after 2002 and continued to decline in subsequent years. Declines were most marked for standard-dose EPT and in older women. The results of the CEE study were less negative, compared with those for EPT, as they showed no effect on CHD, a nonsignificant reduction in the risk of breast cancer, and a more favorable risk-benefit ratio for younger women, compared with older women. A decade later, it had become widely accepted that MHT should not be used for the prevention of chronic disease in older women; however, short-term use for treatment of vasomotor symptoms remains an accepted indication.
 

Risks and outcomes

Emerging from a series of WHI reports are complex models on the effect of hormonal therapy on the risk and outcome of breast cancer. In one study, women with an intact uterus received CEEs plus medroxyprogesterone acetate (MPA). An increase in the risk of breast cancer was observed over a median of 5.6 years of treatment, followed by a moderate reduction, with the risk increasing after 13 years of cumulative follow-up. For women treated with CEE alone, the reduction in risk observed over an average of 7.2 years of treatment was maintained for 13 years of follow-up.

Results from observational studies contrast with those from randomized controlled trials, particularly those concerning the use of estrogens only. A meta-analysis by the Collaborative Group on Hormonal Factors in Breast Cancer showed that both EPT and CEE were associated with a higher risk of breast neoplasia. Results of the Million Women Study showed a higher death rate.
 

Treatment methods and duration

Information from prospective studies on the effects of commencing MHT at various ages between 40 and 59 years show that for women who commenced treatment at any time within this age range, the relative risk was similar and was highly significant for all ages. Few women had started MHT treatment well after menopause at ages 60-69 years, and their excess risks during years 5-14 of current use were significant for estrogen-progestogen but not for estrogen-only MHT.

If these associations are largely causal, then for women of average weight in developed countries, 5 years of MHT, starting at age 50 years, would increase breast cancer incidence at ages 50-69 years by about 1 in every 50 users of estrogen plus daily progestogen preparations; 1 in every 70 users of estrogen plus intermittent progestogen preparations; and 1 in every 200 users of estrogen-only preparations. The corresponding excesses from 10 years of MHT would be about twice as great.

During 5-14 years of MHT use, the RRs were similarly increased if MHT use had started at ages 40-44 years, 45-49 years, 50-54 years, and 55-59 years; RRs appeared to be attenuated if MHT use had started after age 60 years. They were also attenuated by adiposity, particularly for estrogen-only MHT (which had little effect in obese women). After MHT use ceased, some excess risk of breast cancer persisted for more than a decade; this is directly correlated with the duration of treatment.

Therefore, it can be expected that the effects of MHT may vary between participants on the basis of age or time since menopause, as well as treatments (MHT type, dose, formulation, duration of use, and route of administration). Regarding formulation effects on the risk of breast cancer, new evidence shows an increased risk of 28%. Progestogens appeared to be differentially associated with breast cancer (micronized progesterone: odds ratio, 0.99; 95% confidence interval 0.55-1.79; synthetic progestin: OR, 1.28; 95% CI, 1.22-1.35). When prescribing MHT, micronized progesterone may be the safer progestogen to use.

In conclusion, MHT has a complex balance of benefits and risk on various health outcomes. Some effects differ qualitatively between ET and EPT. Regarding use of MHT, consideration should be given to the full range of effects, along with patients’ values and preferences. The overall quality of existing systematic reviews is moderate to poor. Clinicians should evaluate their scientific strength before considering applying their results in clinical practice. Regarding use of any hormone therapy regimen, consideration should be given to the full range of risk and benefits and should involve shared decisionmaking with the patient. It should be recognized that risk-benefit balance is altered by factors such as age, time from menopause, oophorectomy status, and prior hysterectomy and that some outcomes persist and there is some attenuation after stopping use.

This article was translated from Univadis Italy.

A version of the article appeared on Medscape.com.

It is projected that by 2050, 1.6 billion women in the world will have reached menopause or the postmenopausal period, a significant increase, compared with a billion women in 2020. Of all menopausal women, around 75% are affected by troublesome menopause symptoms, such as hot flashes and night sweats.

Around 84% of postmenopausal women experience genitourinary symptoms, such as vulvovaginal atrophy and incontinence.

Menopausal hormone therapy (MHT) is the most effective treatment for managing these symptoms; however, its effects on numerous aspects of female health remain uncertain, in particular with regard to breast cancer. The influence of MHT on breast cancer remains unsettled, with discordant findings from observational studies and randomized clinical trials, a factor that affects the decisions made by doctors concerning hormone therapy in menopausal women.
 

Background

Conjugated equine estrogens (CEEs) were introduced into clinical practice in the 1940s. For decades, MHT was the main treatment in conventional medicine for the symptoms of menopause. MHT was used in Western countries for about 600 million women starting from 1970, and it progressively increased during the 1990s. Professional organizations recommended MHT for the prevention of osteoporosis and chronic heart disease (CHD), and a third of prescriptions were for women older than 60 years.

Against this background, the National Institutes of Health launched randomized trials of MHT through the Women’s Health Initiative (WHI) to test whether the association with reduced risk for CHD found in observational studies was real and to obtain reliable information on the overall risks and benefits regarding the prevention of chronic disease for postmenopausal women aged 50-79 years.

The WHI trials tested standard-dose oral CEEs with and without standard-dose continuous medroxyprogesterone acetate (EPT). In 2002, the results of the WHI studies raised a series of concerns about the long-term safety of MHT, in particular the finding of an increased risk of breast cancer for women undergoing therapy. That risk exceeded the benefits from reductions in hip fractures and colorectal cancer.

The WHI findings received wide attention. Prescriptions for MHT dropped precipitously after 2002 and continued to decline in subsequent years. Declines were most marked for standard-dose EPT and in older women. The results of the CEE study were less negative, compared with those for EPT, as they showed no effect on CHD, a nonsignificant reduction in the risk of breast cancer, and a more favorable risk-benefit ratio for younger women, compared with older women. A decade later, it had become widely accepted that MHT should not be used for the prevention of chronic disease in older women; however, short-term use for treatment of vasomotor symptoms remains an accepted indication.
 

Risks and outcomes

Emerging from a series of WHI reports are complex models on the effect of hormonal therapy on the risk and outcome of breast cancer. In one study, women with an intact uterus received CEEs plus medroxyprogesterone acetate (MPA). An increase in the risk of breast cancer was observed over a median of 5.6 years of treatment, followed by a moderate reduction, with the risk increasing after 13 years of cumulative follow-up. For women treated with CEE alone, the reduction in risk observed over an average of 7.2 years of treatment was maintained for 13 years of follow-up.

Results from observational studies contrast with those from randomized controlled trials, particularly those concerning the use of estrogens only. A meta-analysis by the Collaborative Group on Hormonal Factors in Breast Cancer showed that both EPT and CEE were associated with a higher risk of breast neoplasia. Results of the Million Women Study showed a higher death rate.
 

Treatment methods and duration

Information from prospective studies on the effects of commencing MHT at various ages between 40 and 59 years show that for women who commenced treatment at any time within this age range, the relative risk was similar and was highly significant for all ages. Few women had started MHT treatment well after menopause at ages 60-69 years, and their excess risks during years 5-14 of current use were significant for estrogen-progestogen but not for estrogen-only MHT.

If these associations are largely causal, then for women of average weight in developed countries, 5 years of MHT, starting at age 50 years, would increase breast cancer incidence at ages 50-69 years by about 1 in every 50 users of estrogen plus daily progestogen preparations; 1 in every 70 users of estrogen plus intermittent progestogen preparations; and 1 in every 200 users of estrogen-only preparations. The corresponding excesses from 10 years of MHT would be about twice as great.

During 5-14 years of MHT use, the RRs were similarly increased if MHT use had started at ages 40-44 years, 45-49 years, 50-54 years, and 55-59 years; RRs appeared to be attenuated if MHT use had started after age 60 years. They were also attenuated by adiposity, particularly for estrogen-only MHT (which had little effect in obese women). After MHT use ceased, some excess risk of breast cancer persisted for more than a decade; this is directly correlated with the duration of treatment.

Therefore, it can be expected that the effects of MHT may vary between participants on the basis of age or time since menopause, as well as treatments (MHT type, dose, formulation, duration of use, and route of administration). Regarding formulation effects on the risk of breast cancer, new evidence shows an increased risk of 28%. Progestogens appeared to be differentially associated with breast cancer (micronized progesterone: odds ratio, 0.99; 95% confidence interval 0.55-1.79; synthetic progestin: OR, 1.28; 95% CI, 1.22-1.35). When prescribing MHT, micronized progesterone may be the safer progestogen to use.

In conclusion, MHT has a complex balance of benefits and risk on various health outcomes. Some effects differ qualitatively between ET and EPT. Regarding use of MHT, consideration should be given to the full range of effects, along with patients’ values and preferences. The overall quality of existing systematic reviews is moderate to poor. Clinicians should evaluate their scientific strength before considering applying their results in clinical practice. Regarding use of any hormone therapy regimen, consideration should be given to the full range of risk and benefits and should involve shared decisionmaking with the patient. It should be recognized that risk-benefit balance is altered by factors such as age, time from menopause, oophorectomy status, and prior hysterectomy and that some outcomes persist and there is some attenuation after stopping use.

This article was translated from Univadis Italy.

A version of the article appeared on Medscape.com.

Consumers, employers, and just about everyone else interested in health care prices will soon get an unprecedented look at what insurers pay for care, perhaps helping answer a question that has long dogged those who buy insurance: Are we getting the best deal we can?

As of July 1, health insurers and self-insured employers must post on websites just about every price they’ve negotiated with providers for health care services, item by item. About the only thing excluded are the prices paid for prescription drugs, except those administered in hospitals or doctors’ offices.

The federally required data release could affect future prices or even how employers contract for health care. Many will see for the first time how well their insurers are doing, compared with others.

The new rules are far broader than those that went into effect in 2021 requiring hospitals to post their negotiated rates for the public to see. Now insurers must post the amounts paid for “every physician in network, every hospital, every surgery center, every nursing facility,” said Jeffrey Leibach, a partner at the consulting firm Guidehouse.

“When you start doing the math, you’re talking trillions of records,” he said. The fines the federal government could impose for noncompliance are also heftier than the penalties that hospitals face.

Federal officials learned from the hospital experience and gave insurers more direction on what was expected, said Mr. Leibach. Insurers or self-insured employers could be fined as much as $100 a day for each violation, for each affected enrollee if they fail to provide the data.

“Get your calculator out: All of a sudden you are in the millions pretty fast,” Mr. Leibach said.

Determined consumers, especially those with high-deductible health plans, may try to dig in right away and use the data to try comparing what they will have to pay at different hospitals, clinics, or doctor offices for specific services.

But each database’s enormous size may mean that most people “will find it very hard to use the data in a nuanced way,” said Katherine Baicker, dean of the University of Chicago Harris School of Public Policy.

At least at first.

Entrepreneurs are expected to quickly translate the information into more user-friendly formats so it can be incorporated into new or existing services that estimate costs for patients. And starting Jan. 1, the rules require insurers to provide online tools that will help people get up-front cost estimates for about 500 so-called “shoppable” services, meaning medical care they can schedule ahead of time.

Once those things happen, “you’ll at least have the options in front of you,” said Chris Severn, CEO of Turquoise Health, an online company that has posted price information made available under the rules for hospitals, although many hospitals have yet to comply.

With the addition of the insurers’ data, sites like his will be able to drill down further into cost variation from one place to another or among insurers.

“If you’re going to get an x-ray, you will be able to see that you can do it for $250 at this hospital, $75 at the imaging center down the road, or your specialist can do it in office for $25,” he said.

Everyone will know everyone else’s business: for example, how much insurers Aetna and Humana pay the same surgery center for a knee replacement.

The requirements stem from the Affordable Care Act and a 2019 executive order by then-President Donald Trump.

“These plans are supposed to be acting on behalf of employers in negotiating good rates, and the little insight we have on that shows it has not happened,” said Elizabeth Mitchell, president and CEO of the Purchaser Business Group on Health, an affiliation of employers who offer job-based health benefits to workers. “I do believe the dynamics are going to change.”

Other observers are more circumspect.

“Maybe at best this will reduce the wide variance of prices out there,” said Zack Cooper, director of health policy at the Yale University Institution for Social and Policy Studies, New Haven, Conn. “But it won’t be unleashing a consumer revolution.”

Still, the biggest value of the July data release may well be to shed light on how successful insurers have been at negotiating prices. It comes on the heels of research that has shown tremendous variation in what is paid for health care. A recent study by Rand, for example, shows that employers that offer job-based insurance plans paid, on average, 224% more than Medicare for the same services.

Tens of thousands of employers who buy insurance coverage for their workers will get this more-complete pricing picture – and may not like what they see.

“What we’re learning from the hospital data is that insurers are really bad at negotiating,” said Gerard Anderson, a professor in the department of health policy at the Johns Hopkins Bloomberg, Baltimore, citing research that found that negotiated rates for hospital care can be higher than what the facilities accept from patients who are not using insurance and are paying cash.

That could add to the frustration that Ms. Mitchell and others say employers have with the current health insurance system. More might try to contract with providers directly, only using insurance companies for claims processing.

Other employers may bring their insurers back to the bargaining table.

“For the first time, an employer will be able to go to an insurance company and say: ‘You have not negotiated a good-enough deal, and we know that because we can see the same provider has negotiated a better deal with another company,’ ” said James Gelfand, president of the ERISA Industry Committee, a trade group of self-insured employers.

If that happens, he added, “patients will be able to save money.”

That’s not necessarily a given, however.

Because this kind of public release of pricing data hasn’t been tried widely in health care before, how it will affect future spending remains uncertain. If insurers are pushed back to the bargaining table or providers see where they stand relative to their peers, prices could drop. However, some providers could raise their prices if they see they are charging less than their peers.

“Downward pressure may not be a given,” said Kelley Schultz, vice president of commercial policy for AHIP, the industry’s trade lobby.

Ms. Baicker said that, even after the data is out, rates will continue to be heavily influenced by local conditions, such as the size of an insurer or employer – providers often give bigger discounts, for example, to the insurers or self-insured employers that can send them the most patients. The number of hospitals in a region also matters – if an area has only one, for instance, that usually means the facility can demand higher rates.

Another unknown: Will insurers meet the deadline and provide usable data?

Ms. Schultz, at AHIP, said the industry is well on the way, partly because the original deadline was extended by 6 months. She expects insurers to do better than the hospital industry. “We saw a lot of hospitals that just decided not to post files or make them difficult to find,” she said.

So far, more than 300 noncompliant hospitals received warning letters from the government. But they could face fines of $300 a day fines for failing to comply, which is less than what insurers potentially face, although the federal government has recently upped the ante to up to $5,500 a day for the largest facilities.

Even after the pricing data is public, “I don’t think things will change overnight,” said Mr. Leibach. “Patients are still going to make care decisions based on their doctors and referrals, a lot of reasons other than price.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

Consumers, employers, and just about everyone else interested in health care prices will soon get an unprecedented look at what insurers pay for care, perhaps helping answer a question that has long dogged those who buy insurance: Are we getting the best deal we can?

As of July 1, health insurers and self-insured employers must post on websites just about every price they’ve negotiated with providers for health care services, item by item. About the only thing excluded are the prices paid for prescription drugs, except those administered in hospitals or doctors’ offices.

The federally required data release could affect future prices or even how employers contract for health care. Many will see for the first time how well their insurers are doing, compared with others.

The new rules are far broader than those that went into effect in 2021 requiring hospitals to post their negotiated rates for the public to see. Now insurers must post the amounts paid for “every physician in network, every hospital, every surgery center, every nursing facility,” said Jeffrey Leibach, a partner at the consulting firm Guidehouse.

“When you start doing the math, you’re talking trillions of records,” he said. The fines the federal government could impose for noncompliance are also heftier than the penalties that hospitals face.

Federal officials learned from the hospital experience and gave insurers more direction on what was expected, said Mr. Leibach. Insurers or self-insured employers could be fined as much as $100 a day for each violation, for each affected enrollee if they fail to provide the data.

“Get your calculator out: All of a sudden you are in the millions pretty fast,” Mr. Leibach said.

Determined consumers, especially those with high-deductible health plans, may try to dig in right away and use the data to try comparing what they will have to pay at different hospitals, clinics, or doctor offices for specific services.

But each database’s enormous size may mean that most people “will find it very hard to use the data in a nuanced way,” said Katherine Baicker, dean of the University of Chicago Harris School of Public Policy.

At least at first.

Entrepreneurs are expected to quickly translate the information into more user-friendly formats so it can be incorporated into new or existing services that estimate costs for patients. And starting Jan. 1, the rules require insurers to provide online tools that will help people get up-front cost estimates for about 500 so-called “shoppable” services, meaning medical care they can schedule ahead of time.

Once those things happen, “you’ll at least have the options in front of you,” said Chris Severn, CEO of Turquoise Health, an online company that has posted price information made available under the rules for hospitals, although many hospitals have yet to comply.

With the addition of the insurers’ data, sites like his will be able to drill down further into cost variation from one place to another or among insurers.

“If you’re going to get an x-ray, you will be able to see that you can do it for $250 at this hospital, $75 at the imaging center down the road, or your specialist can do it in office for $25,” he said.

Everyone will know everyone else’s business: for example, how much insurers Aetna and Humana pay the same surgery center for a knee replacement.

The requirements stem from the Affordable Care Act and a 2019 executive order by then-President Donald Trump.

“These plans are supposed to be acting on behalf of employers in negotiating good rates, and the little insight we have on that shows it has not happened,” said Elizabeth Mitchell, president and CEO of the Purchaser Business Group on Health, an affiliation of employers who offer job-based health benefits to workers. “I do believe the dynamics are going to change.”

Other observers are more circumspect.

“Maybe at best this will reduce the wide variance of prices out there,” said Zack Cooper, director of health policy at the Yale University Institution for Social and Policy Studies, New Haven, Conn. “But it won’t be unleashing a consumer revolution.”

Still, the biggest value of the July data release may well be to shed light on how successful insurers have been at negotiating prices. It comes on the heels of research that has shown tremendous variation in what is paid for health care. A recent study by Rand, for example, shows that employers that offer job-based insurance plans paid, on average, 224% more than Medicare for the same services.

Tens of thousands of employers who buy insurance coverage for their workers will get this more-complete pricing picture – and may not like what they see.

“What we’re learning from the hospital data is that insurers are really bad at negotiating,” said Gerard Anderson, a professor in the department of health policy at the Johns Hopkins Bloomberg, Baltimore, citing research that found that negotiated rates for hospital care can be higher than what the facilities accept from patients who are not using insurance and are paying cash.

That could add to the frustration that Ms. Mitchell and others say employers have with the current health insurance system. More might try to contract with providers directly, only using insurance companies for claims processing.

Other employers may bring their insurers back to the bargaining table.

“For the first time, an employer will be able to go to an insurance company and say: ‘You have not negotiated a good-enough deal, and we know that because we can see the same provider has negotiated a better deal with another company,’ ” said James Gelfand, president of the ERISA Industry Committee, a trade group of self-insured employers.

If that happens, he added, “patients will be able to save money.”

That’s not necessarily a given, however.

Because this kind of public release of pricing data hasn’t been tried widely in health care before, how it will affect future spending remains uncertain. If insurers are pushed back to the bargaining table or providers see where they stand relative to their peers, prices could drop. However, some providers could raise their prices if they see they are charging less than their peers.

“Downward pressure may not be a given,” said Kelley Schultz, vice president of commercial policy for AHIP, the industry’s trade lobby.

Ms. Baicker said that, even after the data is out, rates will continue to be heavily influenced by local conditions, such as the size of an insurer or employer – providers often give bigger discounts, for example, to the insurers or self-insured employers that can send them the most patients. The number of hospitals in a region also matters – if an area has only one, for instance, that usually means the facility can demand higher rates.

Another unknown: Will insurers meet the deadline and provide usable data?

Ms. Schultz, at AHIP, said the industry is well on the way, partly because the original deadline was extended by 6 months. She expects insurers to do better than the hospital industry. “We saw a lot of hospitals that just decided not to post files or make them difficult to find,” she said.

So far, more than 300 noncompliant hospitals received warning letters from the government. But they could face fines of $300 a day fines for failing to comply, which is less than what insurers potentially face, although the federal government has recently upped the ante to up to $5,500 a day for the largest facilities.

Even after the pricing data is public, “I don’t think things will change overnight,” said Mr. Leibach. “Patients are still going to make care decisions based on their doctors and referrals, a lot of reasons other than price.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

Consumers, employers, and just about everyone else interested in health care prices will soon get an unprecedented look at what insurers pay for care, perhaps helping answer a question that has long dogged those who buy insurance: Are we getting the best deal we can?

As of July 1, health insurers and self-insured employers must post on websites just about every price they’ve negotiated with providers for health care services, item by item. About the only thing excluded are the prices paid for prescription drugs, except those administered in hospitals or doctors’ offices.

The federally required data release could affect future prices or even how employers contract for health care. Many will see for the first time how well their insurers are doing, compared with others.

The new rules are far broader than those that went into effect in 2021 requiring hospitals to post their negotiated rates for the public to see. Now insurers must post the amounts paid for “every physician in network, every hospital, every surgery center, every nursing facility,” said Jeffrey Leibach, a partner at the consulting firm Guidehouse.

“When you start doing the math, you’re talking trillions of records,” he said. The fines the federal government could impose for noncompliance are also heftier than the penalties that hospitals face.

Federal officials learned from the hospital experience and gave insurers more direction on what was expected, said Mr. Leibach. Insurers or self-insured employers could be fined as much as $100 a day for each violation, for each affected enrollee if they fail to provide the data.

“Get your calculator out: All of a sudden you are in the millions pretty fast,” Mr. Leibach said.

Determined consumers, especially those with high-deductible health plans, may try to dig in right away and use the data to try comparing what they will have to pay at different hospitals, clinics, or doctor offices for specific services.

But each database’s enormous size may mean that most people “will find it very hard to use the data in a nuanced way,” said Katherine Baicker, dean of the University of Chicago Harris School of Public Policy.

At least at first.

Entrepreneurs are expected to quickly translate the information into more user-friendly formats so it can be incorporated into new or existing services that estimate costs for patients. And starting Jan. 1, the rules require insurers to provide online tools that will help people get up-front cost estimates for about 500 so-called “shoppable” services, meaning medical care they can schedule ahead of time.

Once those things happen, “you’ll at least have the options in front of you,” said Chris Severn, CEO of Turquoise Health, an online company that has posted price information made available under the rules for hospitals, although many hospitals have yet to comply.

With the addition of the insurers’ data, sites like his will be able to drill down further into cost variation from one place to another or among insurers.

“If you’re going to get an x-ray, you will be able to see that you can do it for $250 at this hospital, $75 at the imaging center down the road, or your specialist can do it in office for $25,” he said.

Everyone will know everyone else’s business: for example, how much insurers Aetna and Humana pay the same surgery center for a knee replacement.

The requirements stem from the Affordable Care Act and a 2019 executive order by then-President Donald Trump.

“These plans are supposed to be acting on behalf of employers in negotiating good rates, and the little insight we have on that shows it has not happened,” said Elizabeth Mitchell, president and CEO of the Purchaser Business Group on Health, an affiliation of employers who offer job-based health benefits to workers. “I do believe the dynamics are going to change.”

Other observers are more circumspect.

“Maybe at best this will reduce the wide variance of prices out there,” said Zack Cooper, director of health policy at the Yale University Institution for Social and Policy Studies, New Haven, Conn. “But it won’t be unleashing a consumer revolution.”

Still, the biggest value of the July data release may well be to shed light on how successful insurers have been at negotiating prices. It comes on the heels of research that has shown tremendous variation in what is paid for health care. A recent study by Rand, for example, shows that employers that offer job-based insurance plans paid, on average, 224% more than Medicare for the same services.

Tens of thousands of employers who buy insurance coverage for their workers will get this more-complete pricing picture – and may not like what they see.

“What we’re learning from the hospital data is that insurers are really bad at negotiating,” said Gerard Anderson, a professor in the department of health policy at the Johns Hopkins Bloomberg, Baltimore, citing research that found that negotiated rates for hospital care can be higher than what the facilities accept from patients who are not using insurance and are paying cash.

That could add to the frustration that Ms. Mitchell and others say employers have with the current health insurance system. More might try to contract with providers directly, only using insurance companies for claims processing.

Other employers may bring their insurers back to the bargaining table.

“For the first time, an employer will be able to go to an insurance company and say: ‘You have not negotiated a good-enough deal, and we know that because we can see the same provider has negotiated a better deal with another company,’ ” said James Gelfand, president of the ERISA Industry Committee, a trade group of self-insured employers.

If that happens, he added, “patients will be able to save money.”

That’s not necessarily a given, however.

Because this kind of public release of pricing data hasn’t been tried widely in health care before, how it will affect future spending remains uncertain. If insurers are pushed back to the bargaining table or providers see where they stand relative to their peers, prices could drop. However, some providers could raise their prices if they see they are charging less than their peers.

“Downward pressure may not be a given,” said Kelley Schultz, vice president of commercial policy for AHIP, the industry’s trade lobby.

Ms. Baicker said that, even after the data is out, rates will continue to be heavily influenced by local conditions, such as the size of an insurer or employer – providers often give bigger discounts, for example, to the insurers or self-insured employers that can send them the most patients. The number of hospitals in a region also matters – if an area has only one, for instance, that usually means the facility can demand higher rates.

Another unknown: Will insurers meet the deadline and provide usable data?

Ms. Schultz, at AHIP, said the industry is well on the way, partly because the original deadline was extended by 6 months. She expects insurers to do better than the hospital industry. “We saw a lot of hospitals that just decided not to post files or make them difficult to find,” she said.

So far, more than 300 noncompliant hospitals received warning letters from the government. But they could face fines of $300 a day fines for failing to comply, which is less than what insurers potentially face, although the federal government has recently upped the ante to up to $5,500 a day for the largest facilities.

Even after the pricing data is public, “I don’t think things will change overnight,” said Mr. Leibach. “Patients are still going to make care decisions based on their doctors and referrals, a lot of reasons other than price.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

Primary care providers could add more than $100,000 to their incomes by billing more often for prevention and coordination of care services using Medicare codes, a new study shows.

According to the new research, primary care physicians used these codes for a median of only 2.3% of services provided to eligible patients.

“Investing in primary care is good for the health of patients, for achieving health equity, and for improving the value of health care spending, and yet the U.S. underinvests in primary care,” lead author Sumit D. Agarwal, MD, of Brigham and Women’s Hospital, Boston, said in an interview.

“One strategy to rectify this has been to add billing codes to the physician fee schedule for PCPs to use and thus raise primary care spending; Medicare has been activating new codes for the better part of 2 decades, and we wanted to investigate how successful this strategy of adding codes to the Medicare Physician Fee Schedule (MPFS) schedule has been to inform discussions on how best to finance primary care in the United States,” he said.

In a study published in Annals of Internal Medicine, Dr. Agarwal and colleagues reviewed nationally representative claims and survey data from 2019 and 2020. They analyzed 34 distinct prevention and coordination codes in 13 categories that have been added the MPFS since 2005. Of these, four involved coordination of care (cognitive impairment, behavioral health integration, chronic care management, and transitional care management). The other nine categories in prevention were wellness visits, advance care planning, shared decision making for lung cancer screening, obesity counseling, behavioral counseling for CVD, depression screening, alcohol misuse counseling, alcohol misuse screening, and smoking cessation counseling.

Overall, 8.8%-100% of older adult patients were eligible for preventive services. A range of patients (5.0%-60.6%) had codes for receiving services in their patient information.

“However, a much smaller fraction of eligible patients was billed for having received the service, ranging from less than 1% for alcohol misuse counseling or obesity counseling to 35.8% for wellness visits, with most below 10%,” the researchers wrote.

The median use of billing codes was 2.3% for eligible patients.

A PCP who provided and billed preventive services to half of all eligible patients could potentially increase revenues of $1,269 to $45,406 per code, with an annual revenue increase of $124,435 (interquartile range $30,654 to $226,813) for prevention services. Similarly, providing and billing coordination of care service to half of all eligible patients could increase revenue by $86,082 (IQR, $18,011 to $154,152).

“Importantly, all of these prevention and coordination codes involve decomposing the comprehensive care of a patient into component parts, each with multiple steps and checklists, which may be inconsistent with how PCPs practice and document care,” the researchers wrote in their discussion. “Unlike hospitals, primary care practices are typically unable to use departments of trained coders to maximize billing and ensure that documentation matches the requirements specified in billing rules,” they added.

The study findings were limited by several factors including the focus only on the Medicare segment of PCPs’ panels, which suggests conservative estimates of reimbursement, the researchers noted. Other limitations include response bias to the use of surveys, lack of survey data on specific billing requirements, and the potential underestimation of services by PCPs who delivered some, but not all, components of a service code.

However, the results reflect previous research to show the underutilization of prevention and coordination codes in primary care, and the need for ways to increase their use, the researchers said. “The discrepancies between service eligibility, provision of services regardless of billing, and actual billing suggest that attempting to codify each distinct activity done by a PCP in the MPFS may not be an effective strategy for supporting primary care,” they concluded.
 

Barriers to code use persist for PCPs

“What surprised us was that there were many codes; we analyzed 34 in the paper in 13 distinct categories of services, and Medicare continues to add new primary care codes to the fee schedule,” Dr. Agarwal said in an interview. Also surprising, “take-up is low virtually across the board, and this isn’t for lack of eligibility,” he said. The low use of the codes “is not for lack of counseling patients on diet, drinking, exercise, smoking, or anything else for which these codes are meant to pay PCPs ... The potential revenue from these codes in aggregate is huge,” Dr. Agarwal emphasized.

“My hope is not necessarily that physicians read this study and start using some or all of these codes more frequently,” said Dr. Agarwal. “It can be tempting to think of this as money left on the table, but it’s not; there are compliance, billing, and opportunity costs from using these codes,” he said. “For individual PCPs seeing individual patients for the breadth that is primary care, I’m not sure the juice is worth the squeeze,” he added. “My coauthors and I are all primary care physicians. We know from our research and first-hand that these codes can be cumbersome to use.” These codes also don’t reflect how PCPs practice, he said. “PCPs are not in the business of slicing and dicing a visit or patient to extract as much revenue as possible. The physician-patient interaction is more complex, and richer, than these codes imply. Instead, I hope our paper encourages Medicare and policymakers to take a harder look at other strategies for investing in primary care,” Dr. Agarwal added.

As for additional research, “Primary care spending is going in the wrong direction,” said Dr. Agarwal. “We need to figure out how best to finance primary care in the United States.”

Recent studies have examined the successes and limitations of the primary care medical home model, Medicare’s Comprehensive Primary Care Initiative, and primary care spending legislation, he said. “Our study is another piece of the puzzle: at least in its current form,” and the results suggest “that one-off codes were nice in theory but not in practice,” he noted.
 

New codes are cumbersome

“It’s tempting to interpret underuse of new billing codes as a simple change management problem,” Davoren Chick, MD, chief learning officer of the American College of Physicians, wrote in an accompanying editorial. However, the underuse of codes for preventive service and coordination of care likely stems from the details of the codes, he said.

The new codes require the documentation of specific components and a minimum duration of services, he explained. “Codes that reward discrete service episodes disadvantage physicians who appropriately integrate preventive services within a continuous patient care relationship,” he added.

Dr. Chick presented an example of a primary care physician who would have to deliver intensive behavioral therapy for obesity in 15-minute episodes outside of a routine office visit to meet the billing criteria for current Medicare codes.

Dr. Chick called on clinicians to educate themselves on the coding rules for the services they provide “not only to optimize current payment but also to advocate for change.”

He concluded: “Widespread underuse of new preventive service and coordination of care codes reflects system failure, not physician failure. We must stand firm with this knowledge to demand increased payment for feasible, patient-centered primary care commensurate with its value in achieving better outcomes and lower costs.”

The study was supported by the National Institute on Aging of the National Institutes of Health. Dr. Agarwal and Dr. Chick had no financial conflicts to disclose.

Primary care providers could add more than $100,000 to their incomes by billing more often for prevention and coordination of care services using Medicare codes, a new study shows.

According to the new research, primary care physicians used these codes for a median of only 2.3% of services provided to eligible patients.

“Investing in primary care is good for the health of patients, for achieving health equity, and for improving the value of health care spending, and yet the U.S. underinvests in primary care,” lead author Sumit D. Agarwal, MD, of Brigham and Women’s Hospital, Boston, said in an interview.

“One strategy to rectify this has been to add billing codes to the physician fee schedule for PCPs to use and thus raise primary care spending; Medicare has been activating new codes for the better part of 2 decades, and we wanted to investigate how successful this strategy of adding codes to the Medicare Physician Fee Schedule (MPFS) schedule has been to inform discussions on how best to finance primary care in the United States,” he said.

In a study published in Annals of Internal Medicine, Dr. Agarwal and colleagues reviewed nationally representative claims and survey data from 2019 and 2020. They analyzed 34 distinct prevention and coordination codes in 13 categories that have been added the MPFS since 2005. Of these, four involved coordination of care (cognitive impairment, behavioral health integration, chronic care management, and transitional care management). The other nine categories in prevention were wellness visits, advance care planning, shared decision making for lung cancer screening, obesity counseling, behavioral counseling for CVD, depression screening, alcohol misuse counseling, alcohol misuse screening, and smoking cessation counseling.

Overall, 8.8%-100% of older adult patients were eligible for preventive services. A range of patients (5.0%-60.6%) had codes for receiving services in their patient information.

“However, a much smaller fraction of eligible patients was billed for having received the service, ranging from less than 1% for alcohol misuse counseling or obesity counseling to 35.8% for wellness visits, with most below 10%,” the researchers wrote.

The median use of billing codes was 2.3% for eligible patients.

A PCP who provided and billed preventive services to half of all eligible patients could potentially increase revenues of $1,269 to $45,406 per code, with an annual revenue increase of $124,435 (interquartile range $30,654 to $226,813) for prevention services. Similarly, providing and billing coordination of care service to half of all eligible patients could increase revenue by $86,082 (IQR, $18,011 to $154,152).

“Importantly, all of these prevention and coordination codes involve decomposing the comprehensive care of a patient into component parts, each with multiple steps and checklists, which may be inconsistent with how PCPs practice and document care,” the researchers wrote in their discussion. “Unlike hospitals, primary care practices are typically unable to use departments of trained coders to maximize billing and ensure that documentation matches the requirements specified in billing rules,” they added.

The study findings were limited by several factors including the focus only on the Medicare segment of PCPs’ panels, which suggests conservative estimates of reimbursement, the researchers noted. Other limitations include response bias to the use of surveys, lack of survey data on specific billing requirements, and the potential underestimation of services by PCPs who delivered some, but not all, components of a service code.

However, the results reflect previous research to show the underutilization of prevention and coordination codes in primary care, and the need for ways to increase their use, the researchers said. “The discrepancies between service eligibility, provision of services regardless of billing, and actual billing suggest that attempting to codify each distinct activity done by a PCP in the MPFS may not be an effective strategy for supporting primary care,” they concluded.
 

Barriers to code use persist for PCPs

“What surprised us was that there were many codes; we analyzed 34 in the paper in 13 distinct categories of services, and Medicare continues to add new primary care codes to the fee schedule,” Dr. Agarwal said in an interview. Also surprising, “take-up is low virtually across the board, and this isn’t for lack of eligibility,” he said. The low use of the codes “is not for lack of counseling patients on diet, drinking, exercise, smoking, or anything else for which these codes are meant to pay PCPs ... The potential revenue from these codes in aggregate is huge,” Dr. Agarwal emphasized.

“My hope is not necessarily that physicians read this study and start using some or all of these codes more frequently,” said Dr. Agarwal. “It can be tempting to think of this as money left on the table, but it’s not; there are compliance, billing, and opportunity costs from using these codes,” he said. “For individual PCPs seeing individual patients for the breadth that is primary care, I’m not sure the juice is worth the squeeze,” he added. “My coauthors and I are all primary care physicians. We know from our research and first-hand that these codes can be cumbersome to use.” These codes also don’t reflect how PCPs practice, he said. “PCPs are not in the business of slicing and dicing a visit or patient to extract as much revenue as possible. The physician-patient interaction is more complex, and richer, than these codes imply. Instead, I hope our paper encourages Medicare and policymakers to take a harder look at other strategies for investing in primary care,” Dr. Agarwal added.

As for additional research, “Primary care spending is going in the wrong direction,” said Dr. Agarwal. “We need to figure out how best to finance primary care in the United States.”

Recent studies have examined the successes and limitations of the primary care medical home model, Medicare’s Comprehensive Primary Care Initiative, and primary care spending legislation, he said. “Our study is another piece of the puzzle: at least in its current form,” and the results suggest “that one-off codes were nice in theory but not in practice,” he noted.
 

New codes are cumbersome

“It’s tempting to interpret underuse of new billing codes as a simple change management problem,” Davoren Chick, MD, chief learning officer of the American College of Physicians, wrote in an accompanying editorial. However, the underuse of codes for preventive service and coordination of care likely stems from the details of the codes, he said.

The new codes require the documentation of specific components and a minimum duration of services, he explained. “Codes that reward discrete service episodes disadvantage physicians who appropriately integrate preventive services within a continuous patient care relationship,” he added.

Dr. Chick presented an example of a primary care physician who would have to deliver intensive behavioral therapy for obesity in 15-minute episodes outside of a routine office visit to meet the billing criteria for current Medicare codes.

Dr. Chick called on clinicians to educate themselves on the coding rules for the services they provide “not only to optimize current payment but also to advocate for change.”

He concluded: “Widespread underuse of new preventive service and coordination of care codes reflects system failure, not physician failure. We must stand firm with this knowledge to demand increased payment for feasible, patient-centered primary care commensurate with its value in achieving better outcomes and lower costs.”

The study was supported by the National Institute on Aging of the National Institutes of Health. Dr. Agarwal and Dr. Chick had no financial conflicts to disclose.

Primary care providers could add more than $100,000 to their incomes by billing more often for prevention and coordination of care services using Medicare codes, a new study shows.

According to the new research, primary care physicians used these codes for a median of only 2.3% of services provided to eligible patients.

“Investing in primary care is good for the health of patients, for achieving health equity, and for improving the value of health care spending, and yet the U.S. underinvests in primary care,” lead author Sumit D. Agarwal, MD, of Brigham and Women’s Hospital, Boston, said in an interview.

“One strategy to rectify this has been to add billing codes to the physician fee schedule for PCPs to use and thus raise primary care spending; Medicare has been activating new codes for the better part of 2 decades, and we wanted to investigate how successful this strategy of adding codes to the Medicare Physician Fee Schedule (MPFS) schedule has been to inform discussions on how best to finance primary care in the United States,” he said.

In a study published in Annals of Internal Medicine, Dr. Agarwal and colleagues reviewed nationally representative claims and survey data from 2019 and 2020. They analyzed 34 distinct prevention and coordination codes in 13 categories that have been added the MPFS since 2005. Of these, four involved coordination of care (cognitive impairment, behavioral health integration, chronic care management, and transitional care management). The other nine categories in prevention were wellness visits, advance care planning, shared decision making for lung cancer screening, obesity counseling, behavioral counseling for CVD, depression screening, alcohol misuse counseling, alcohol misuse screening, and smoking cessation counseling.

Overall, 8.8%-100% of older adult patients were eligible for preventive services. A range of patients (5.0%-60.6%) had codes for receiving services in their patient information.

“However, a much smaller fraction of eligible patients was billed for having received the service, ranging from less than 1% for alcohol misuse counseling or obesity counseling to 35.8% for wellness visits, with most below 10%,” the researchers wrote.

The median use of billing codes was 2.3% for eligible patients.

A PCP who provided and billed preventive services to half of all eligible patients could potentially increase revenues of $1,269 to $45,406 per code, with an annual revenue increase of $124,435 (interquartile range $30,654 to $226,813) for prevention services. Similarly, providing and billing coordination of care service to half of all eligible patients could increase revenue by $86,082 (IQR, $18,011 to $154,152).

“Importantly, all of these prevention and coordination codes involve decomposing the comprehensive care of a patient into component parts, each with multiple steps and checklists, which may be inconsistent with how PCPs practice and document care,” the researchers wrote in their discussion. “Unlike hospitals, primary care practices are typically unable to use departments of trained coders to maximize billing and ensure that documentation matches the requirements specified in billing rules,” they added.

The study findings were limited by several factors including the focus only on the Medicare segment of PCPs’ panels, which suggests conservative estimates of reimbursement, the researchers noted. Other limitations include response bias to the use of surveys, lack of survey data on specific billing requirements, and the potential underestimation of services by PCPs who delivered some, but not all, components of a service code.

However, the results reflect previous research to show the underutilization of prevention and coordination codes in primary care, and the need for ways to increase their use, the researchers said. “The discrepancies between service eligibility, provision of services regardless of billing, and actual billing suggest that attempting to codify each distinct activity done by a PCP in the MPFS may not be an effective strategy for supporting primary care,” they concluded.
 

Barriers to code use persist for PCPs

“What surprised us was that there were many codes; we analyzed 34 in the paper in 13 distinct categories of services, and Medicare continues to add new primary care codes to the fee schedule,” Dr. Agarwal said in an interview. Also surprising, “take-up is low virtually across the board, and this isn’t for lack of eligibility,” he said. The low use of the codes “is not for lack of counseling patients on diet, drinking, exercise, smoking, or anything else for which these codes are meant to pay PCPs ... The potential revenue from these codes in aggregate is huge,” Dr. Agarwal emphasized.

“My hope is not necessarily that physicians read this study and start using some or all of these codes more frequently,” said Dr. Agarwal. “It can be tempting to think of this as money left on the table, but it’s not; there are compliance, billing, and opportunity costs from using these codes,” he said. “For individual PCPs seeing individual patients for the breadth that is primary care, I’m not sure the juice is worth the squeeze,” he added. “My coauthors and I are all primary care physicians. We know from our research and first-hand that these codes can be cumbersome to use.” These codes also don’t reflect how PCPs practice, he said. “PCPs are not in the business of slicing and dicing a visit or patient to extract as much revenue as possible. The physician-patient interaction is more complex, and richer, than these codes imply. Instead, I hope our paper encourages Medicare and policymakers to take a harder look at other strategies for investing in primary care,” Dr. Agarwal added.

As for additional research, “Primary care spending is going in the wrong direction,” said Dr. Agarwal. “We need to figure out how best to finance primary care in the United States.”

Recent studies have examined the successes and limitations of the primary care medical home model, Medicare’s Comprehensive Primary Care Initiative, and primary care spending legislation, he said. “Our study is another piece of the puzzle: at least in its current form,” and the results suggest “that one-off codes were nice in theory but not in practice,” he noted.
 

New codes are cumbersome

“It’s tempting to interpret underuse of new billing codes as a simple change management problem,” Davoren Chick, MD, chief learning officer of the American College of Physicians, wrote in an accompanying editorial. However, the underuse of codes for preventive service and coordination of care likely stems from the details of the codes, he said.

The new codes require the documentation of specific components and a minimum duration of services, he explained. “Codes that reward discrete service episodes disadvantage physicians who appropriately integrate preventive services within a continuous patient care relationship,” he added.

Dr. Chick presented an example of a primary care physician who would have to deliver intensive behavioral therapy for obesity in 15-minute episodes outside of a routine office visit to meet the billing criteria for current Medicare codes.

Dr. Chick called on clinicians to educate themselves on the coding rules for the services they provide “not only to optimize current payment but also to advocate for change.”

He concluded: “Widespread underuse of new preventive service and coordination of care codes reflects system failure, not physician failure. We must stand firm with this knowledge to demand increased payment for feasible, patient-centered primary care commensurate with its value in achieving better outcomes and lower costs.”

The study was supported by the National Institute on Aging of the National Institutes of Health. Dr. Agarwal and Dr. Chick had no financial conflicts to disclose.

Alabama urged a federal court on June 28 to drop its block on the state’s ban on gender-affirming care for transgender youth, citing the Supreme Court’s recent decision to overturn Roe v. Wade.

Alabama Attorney General Steve Marshall said the high court ruled that abortion isn’t protected under the 14th Amendment because it’s not “deeply rooted” in the nation’s history, which he noted could be said about access to gender-affirming care as well, according to Axios.

“No one – adult or child – has a right to transitioning treatments that is deeply rooted in our Nation’s history and tradition,” he wrote in a court document.

“The State can thus regulate or prohibit those interventions for children, even if an adult wants the drugs for his child,” he wrote.

In May, a federal judge blocked part of Alabama’s Senate Bill 184, which makes it a felony for someone to “engage in or cause” certain types of medical care for transgender youths. The law, which was put in place in April, allows for criminal prosecution against doctors, parents, guardians, and anyone else who provides care to a minor. The penalties could result in up to 10 years in prison and up to $15,000 in fines.

At that time, U.S. District Judge Liles Burke issued an injunction to stop Alabama from enforcing the law and allow challenges, including one filed by the Department of Justice. Mr. Burke said the state provided “no credible evidence to show that transitioning medications are ‘experimental.’ ”

“While Defendants offer some evidence that transitioning medications pose certain risks, the uncontradicted record evidence is that at least twenty-two major medical associations in the United States endorse transitioning medications as well-established, evidence-based treatments for gender dysphoria in minors,” he wrote in the ruling.

Medical organizations such as the American Academy of Pediatrics, American Psychological Association, and American Medical Association have urged governors to oppose legislation this year that would restrict gender-affirming medical care, saying that such laws could have negative effects on the mental health of transgender youths.

But on June 28, Mr. Marshall focused on the Constitution and what he believes the recent overturn of Roe implies.

“Just as the parental relationship does not unlock a Due Process right allowing parents to obtain medical marijuana or abortions for their children, neither does it unlock a right to transitioning treatments,” he wrote.

“The Constitution reserves to the State – not courts or medical interest groups – the authority to determine that these sterilizing interventions are too dangerous for minors,” he said.

Since the Supreme Court overturned Roe, people have expressed concerns that lawsuits could now target several rights that are protected under the 14th Amendment, including same-sex relationships, marriage equality, and access to contraceptives.

Justice Clarence Thomas, who wrote a concurring opinion to the majority decision, said the Supreme Court, “in future cases” should reconsider “substantive due process precedents” under previous landmark cases such as Griswold v. Connecticut, Lawrence v. Texas, and Obergefell v. Hodges.

At the same time, Justice Brett Kavanaugh, who also wrote a concurring opinion, said the decision to overturn Roe was only focused on abortion, saying it “does not mean the overruling of those precedents, and does not threaten or cast doubt on those precedents.”

A version of this article first appeared on WebMD.com.

Alabama urged a federal court on June 28 to drop its block on the state’s ban on gender-affirming care for transgender youth, citing the Supreme Court’s recent decision to overturn Roe v. Wade.

Alabama Attorney General Steve Marshall said the high court ruled that abortion isn’t protected under the 14th Amendment because it’s not “deeply rooted” in the nation’s history, which he noted could be said about access to gender-affirming care as well, according to Axios.

“No one – adult or child – has a right to transitioning treatments that is deeply rooted in our Nation’s history and tradition,” he wrote in a court document.

“The State can thus regulate or prohibit those interventions for children, even if an adult wants the drugs for his child,” he wrote.

In May, a federal judge blocked part of Alabama’s Senate Bill 184, which makes it a felony for someone to “engage in or cause” certain types of medical care for transgender youths. The law, which was put in place in April, allows for criminal prosecution against doctors, parents, guardians, and anyone else who provides care to a minor. The penalties could result in up to 10 years in prison and up to $15,000 in fines.

At that time, U.S. District Judge Liles Burke issued an injunction to stop Alabama from enforcing the law and allow challenges, including one filed by the Department of Justice. Mr. Burke said the state provided “no credible evidence to show that transitioning medications are ‘experimental.’ ”

“While Defendants offer some evidence that transitioning medications pose certain risks, the uncontradicted record evidence is that at least twenty-two major medical associations in the United States endorse transitioning medications as well-established, evidence-based treatments for gender dysphoria in minors,” he wrote in the ruling.

Medical organizations such as the American Academy of Pediatrics, American Psychological Association, and American Medical Association have urged governors to oppose legislation this year that would restrict gender-affirming medical care, saying that such laws could have negative effects on the mental health of transgender youths.

But on June 28, Mr. Marshall focused on the Constitution and what he believes the recent overturn of Roe implies.

“Just as the parental relationship does not unlock a Due Process right allowing parents to obtain medical marijuana or abortions for their children, neither does it unlock a right to transitioning treatments,” he wrote.

“The Constitution reserves to the State – not courts or medical interest groups – the authority to determine that these sterilizing interventions are too dangerous for minors,” he said.

Since the Supreme Court overturned Roe, people have expressed concerns that lawsuits could now target several rights that are protected under the 14th Amendment, including same-sex relationships, marriage equality, and access to contraceptives.

Justice Clarence Thomas, who wrote a concurring opinion to the majority decision, said the Supreme Court, “in future cases” should reconsider “substantive due process precedents” under previous landmark cases such as Griswold v. Connecticut, Lawrence v. Texas, and Obergefell v. Hodges.

At the same time, Justice Brett Kavanaugh, who also wrote a concurring opinion, said the decision to overturn Roe was only focused on abortion, saying it “does not mean the overruling of those precedents, and does not threaten or cast doubt on those precedents.”

A version of this article first appeared on WebMD.com.

Alabama urged a federal court on June 28 to drop its block on the state’s ban on gender-affirming care for transgender youth, citing the Supreme Court’s recent decision to overturn Roe v. Wade.

Alabama Attorney General Steve Marshall said the high court ruled that abortion isn’t protected under the 14th Amendment because it’s not “deeply rooted” in the nation’s history, which he noted could be said about access to gender-affirming care as well, according to Axios.

“No one – adult or child – has a right to transitioning treatments that is deeply rooted in our Nation’s history and tradition,” he wrote in a court document.

“The State can thus regulate or prohibit those interventions for children, even if an adult wants the drugs for his child,” he wrote.

In May, a federal judge blocked part of Alabama’s Senate Bill 184, which makes it a felony for someone to “engage in or cause” certain types of medical care for transgender youths. The law, which was put in place in April, allows for criminal prosecution against doctors, parents, guardians, and anyone else who provides care to a minor. The penalties could result in up to 10 years in prison and up to $15,000 in fines.

At that time, U.S. District Judge Liles Burke issued an injunction to stop Alabama from enforcing the law and allow challenges, including one filed by the Department of Justice. Mr. Burke said the state provided “no credible evidence to show that transitioning medications are ‘experimental.’ ”

“While Defendants offer some evidence that transitioning medications pose certain risks, the uncontradicted record evidence is that at least twenty-two major medical associations in the United States endorse transitioning medications as well-established, evidence-based treatments for gender dysphoria in minors,” he wrote in the ruling.

Medical organizations such as the American Academy of Pediatrics, American Psychological Association, and American Medical Association have urged governors to oppose legislation this year that would restrict gender-affirming medical care, saying that such laws could have negative effects on the mental health of transgender youths.

But on June 28, Mr. Marshall focused on the Constitution and what he believes the recent overturn of Roe implies.

“Just as the parental relationship does not unlock a Due Process right allowing parents to obtain medical marijuana or abortions for their children, neither does it unlock a right to transitioning treatments,” he wrote.

“The Constitution reserves to the State – not courts or medical interest groups – the authority to determine that these sterilizing interventions are too dangerous for minors,” he said.

Since the Supreme Court overturned Roe, people have expressed concerns that lawsuits could now target several rights that are protected under the 14th Amendment, including same-sex relationships, marriage equality, and access to contraceptives.

Justice Clarence Thomas, who wrote a concurring opinion to the majority decision, said the Supreme Court, “in future cases” should reconsider “substantive due process precedents” under previous landmark cases such as Griswold v. Connecticut, Lawrence v. Texas, and Obergefell v. Hodges.

At the same time, Justice Brett Kavanaugh, who also wrote a concurring opinion, said the decision to overturn Roe was only focused on abortion, saying it “does not mean the overruling of those precedents, and does not threaten or cast doubt on those precedents.”

A version of this article first appeared on WebMD.com.

Ain’t gastroenteritis grand?

The Grand Canyon is perhaps America’s greatest natural wonder. The mile-deep gorge of epic proportions, carved over eons by the Colorado River, elicits superlatives of the highest order from those seeing it for the first time. In the past few months, though, visitors to the Grand Canyon have been experiencing a rather more unpleasant sort of reaction: Involuntary bowel evacuation.

Since April, more than 150 river rafters and backcountry campers have fallen ill with bouts of acute gastroenteritis, likely caused by norovirus. Hey, a viral outbreak and our old friend SARS-CoV-2 isn’t involved! Hopefully it won’t get jealous. Whatever the culprit is, however, it got everywhere, as clusters of illness have popped up in unconnected parts of the park and some hikers have been restricted to a smaller portion of the park to avoid further disease spread. The majority of cases occurred in May, so it’s hoped that the outbreak is dying down, but the park remains on alert.

Jon Sullivan/Pixnio

Now, acute gastroenteritis is certainly an unpleasant disease, but it isn’t typically a life-threatening one. There are, however, a couple of unique factors complicating this outbreak. For one, the Grand Canyon is in Arizona (duh), which can get rather hot in the summer months. Expelling waste from both ends becomes rather more dangerous when the thermometer reads over a hundred degrees, and there have been reports of multiple helicopter rescues.

That’s pretty bad, but in a way, they’re the lucky ones. How can we explain this … see, when you visit the Grand Canyon, you’re expected to follow the general rules of Leave No Trace. That means several things, but essentially, if you bring it in, you have to bring it out. Yes, that includes the various consequences of an acute gastroenteritis attack.

Forget spooky campfire stories and hungry wildlife lurking in the night, because true horror is scraping your friend’s diarrhea off the walls of the Grand Canyon into a plastic bag and stuffing it into your backpack. Probably not the sublime one-on-one Grand Canyon experience that people are expecting.
 

Give us a pee! ... for stem cell retrieval

Getting cells for regenerative stem cell treatment has traditionally been painful and difficult – usually they are retrieved by surgical means from bone marrow or fat tissue – but there may be an easier way.

Just pee in a cup.

toeytoey2530/Thinkstock

Apparently, human urine contains stem cells with the potential to be used for regenerative effects. The magic ingredient? The enzyme telomerase, which “is essential for the self-renewal and potential of different types of stem cells” and is related to longevity, according to researchers at Wake Forest Institute for Regenerative Medicine.

They looked into how regenerative telomerase activity is for various capabilities beyond chromosomal stability, and whether these stem cells can become other kinds of cells for optimal tissue repair. Turns out they could, acting as a “distinct subpopulation” that has the ability not only to grow cells but also to morph into other cells, they said in a written statement.

Safety is also an issue. “Being able to use a patient’s own stem cells for therapy is considered advantageous because they do not induce immune responses or rejection,” said Anthony Atala, MD, a coauthor of the study published in Frontiers in Cell and Developmental Biology.

So less risk, easier retrieval, and great regenerative results. If this takes off, the other methods of retrieval could get flushed down the toilet.
 

Politicians playing the long game, literally

Before we get started with actual information, here’s a joke about politicians:

What do you call a lawyer with an IQ of 100? Your Honor.

What do you call a lawyer with an IQ of 50? Senator.

Politics is a dirty business, no doubt, so why do people do it? Is it for the prestige? Seems like everyone hates politicians, so it’s probably not that. Is it their selfless concern for the well-being of others? Probably not that either. Is it for the money? Most members of Congress have more corporate sponsors than a NASCAR driver, but we’re going to pass on that one as well.

Phi Nguyen/House of Representatives

Once again, science gives us the real answer: Longevity. Politicians live longer than the rest of us, and that longevity gap is getting wider.

Investigators looked at data from 11 industrialized countries, some of it going back to 1817, and found that politicians in the United States can expect to live about 7 years longer than the national average. The difference is around 3 years in Switzerland, 4.5 years in Germany, and 6 years in France.

“For almost all countries, politicians had similar rates of mortality to the general population in the late 19th and early 20th centuries. Throughout the 20th century, differences in mortality rates widened significantly across all countries, so that politicians had an increasing survival advantage over the general population,” they said in a written statement.

Income inequality could be a factor, but the longevity gains made by politicians, which started before the 1940s, predate the rise of their earnings relative to the rest of the population, which didn’t really get going until the 1980s, the investigators noted.

Whatever the reason, we have this closing thought regarding our long-lived lawmakers: What’s the difference between a politician and a snail? One is a slimy pest that leaves a trail everywhere. The other is a snail.
 

Land of the free, home of obesity

In the United States, it seems, people are becoming more comfortable with obesity. TikTok and Instagram trends often try to show the world that all sizes are beautiful. There’s also the growing popularity of the dad bod.

PxHere

America, it has been said, is the land of the free. We love our freedom, and we value our individualism. If an obese man orders three meals from McDonald’s just for himself, no one is going to stop him. Many Americans also have more access to the food they want at any given time, even while they are moving around a lot less because of their sedentary lifestyles.

According to a recent study cited by the New York Post, however, America is not the only country battling obesity. Egypt and Mexico, for example, also have men with higher BMIs who cherish their individualism and the right to eat what they want, Plamen Akaliyski, PhD, of University Carlos III of Madrid, and associates, said in Social Science & Medicine.

Women are not as likely to think the same way. “Men in particular think, ‘I’m an individual, don’t tell me what to do. I’m going to eat what I want,’ ” bariatric surgeon George A. Fielding, MD, said in the Post article. Dr. Fielding also noted that women are three times more likely than men to seek bariatric surgery.

Dr. Akaliyski and associates found that Asian countries such as Japan, Singapore, and South Korea – countries that value thrift, discipline, self control, and delaying gratification – have lower rates of obesity.

So yes, we can go to the drive through of a fast food restaurant whenever we want and order whatever we want, but can doesn’t always mean should.

Ain’t gastroenteritis grand?

The Grand Canyon is perhaps America’s greatest natural wonder. The mile-deep gorge of epic proportions, carved over eons by the Colorado River, elicits superlatives of the highest order from those seeing it for the first time. In the past few months, though, visitors to the Grand Canyon have been experiencing a rather more unpleasant sort of reaction: Involuntary bowel evacuation.

Since April, more than 150 river rafters and backcountry campers have fallen ill with bouts of acute gastroenteritis, likely caused by norovirus. Hey, a viral outbreak and our old friend SARS-CoV-2 isn’t involved! Hopefully it won’t get jealous. Whatever the culprit is, however, it got everywhere, as clusters of illness have popped up in unconnected parts of the park and some hikers have been restricted to a smaller portion of the park to avoid further disease spread. The majority of cases occurred in May, so it’s hoped that the outbreak is dying down, but the park remains on alert.

Jon Sullivan/Pixnio

Now, acute gastroenteritis is certainly an unpleasant disease, but it isn’t typically a life-threatening one. There are, however, a couple of unique factors complicating this outbreak. For one, the Grand Canyon is in Arizona (duh), which can get rather hot in the summer months. Expelling waste from both ends becomes rather more dangerous when the thermometer reads over a hundred degrees, and there have been reports of multiple helicopter rescues.

That’s pretty bad, but in a way, they’re the lucky ones. How can we explain this … see, when you visit the Grand Canyon, you’re expected to follow the general rules of Leave No Trace. That means several things, but essentially, if you bring it in, you have to bring it out. Yes, that includes the various consequences of an acute gastroenteritis attack.

Forget spooky campfire stories and hungry wildlife lurking in the night, because true horror is scraping your friend’s diarrhea off the walls of the Grand Canyon into a plastic bag and stuffing it into your backpack. Probably not the sublime one-on-one Grand Canyon experience that people are expecting.
 

Give us a pee! ... for stem cell retrieval

Getting cells for regenerative stem cell treatment has traditionally been painful and difficult – usually they are retrieved by surgical means from bone marrow or fat tissue – but there may be an easier way.

Just pee in a cup.

toeytoey2530/Thinkstock

Apparently, human urine contains stem cells with the potential to be used for regenerative effects. The magic ingredient? The enzyme telomerase, which “is essential for the self-renewal and potential of different types of stem cells” and is related to longevity, according to researchers at Wake Forest Institute for Regenerative Medicine.

They looked into how regenerative telomerase activity is for various capabilities beyond chromosomal stability, and whether these stem cells can become other kinds of cells for optimal tissue repair. Turns out they could, acting as a “distinct subpopulation” that has the ability not only to grow cells but also to morph into other cells, they said in a written statement.

Safety is also an issue. “Being able to use a patient’s own stem cells for therapy is considered advantageous because they do not induce immune responses or rejection,” said Anthony Atala, MD, a coauthor of the study published in Frontiers in Cell and Developmental Biology.

So less risk, easier retrieval, and great regenerative results. If this takes off, the other methods of retrieval could get flushed down the toilet.
 

Politicians playing the long game, literally

Before we get started with actual information, here’s a joke about politicians:

What do you call a lawyer with an IQ of 100? Your Honor.

What do you call a lawyer with an IQ of 50? Senator.

Politics is a dirty business, no doubt, so why do people do it? Is it for the prestige? Seems like everyone hates politicians, so it’s probably not that. Is it their selfless concern for the well-being of others? Probably not that either. Is it for the money? Most members of Congress have more corporate sponsors than a NASCAR driver, but we’re going to pass on that one as well.

Phi Nguyen/House of Representatives

Once again, science gives us the real answer: Longevity. Politicians live longer than the rest of us, and that longevity gap is getting wider.

Investigators looked at data from 11 industrialized countries, some of it going back to 1817, and found that politicians in the United States can expect to live about 7 years longer than the national average. The difference is around 3 years in Switzerland, 4.5 years in Germany, and 6 years in France.

“For almost all countries, politicians had similar rates of mortality to the general population in the late 19th and early 20th centuries. Throughout the 20th century, differences in mortality rates widened significantly across all countries, so that politicians had an increasing survival advantage over the general population,” they said in a written statement.

Income inequality could be a factor, but the longevity gains made by politicians, which started before the 1940s, predate the rise of their earnings relative to the rest of the population, which didn’t really get going until the 1980s, the investigators noted.

Whatever the reason, we have this closing thought regarding our long-lived lawmakers: What’s the difference between a politician and a snail? One is a slimy pest that leaves a trail everywhere. The other is a snail.
 

Land of the free, home of obesity

In the United States, it seems, people are becoming more comfortable with obesity. TikTok and Instagram trends often try to show the world that all sizes are beautiful. There’s also the growing popularity of the dad bod.

PxHere

America, it has been said, is the land of the free. We love our freedom, and we value our individualism. If an obese man orders three meals from McDonald’s just for himself, no one is going to stop him. Many Americans also have more access to the food they want at any given time, even while they are moving around a lot less because of their sedentary lifestyles.

According to a recent study cited by the New York Post, however, America is not the only country battling obesity. Egypt and Mexico, for example, also have men with higher BMIs who cherish their individualism and the right to eat what they want, Plamen Akaliyski, PhD, of University Carlos III of Madrid, and associates, said in Social Science & Medicine.

Women are not as likely to think the same way. “Men in particular think, ‘I’m an individual, don’t tell me what to do. I’m going to eat what I want,’ ” bariatric surgeon George A. Fielding, MD, said in the Post article. Dr. Fielding also noted that women are three times more likely than men to seek bariatric surgery.

Dr. Akaliyski and associates found that Asian countries such as Japan, Singapore, and South Korea – countries that value thrift, discipline, self control, and delaying gratification – have lower rates of obesity.

So yes, we can go to the drive through of a fast food restaurant whenever we want and order whatever we want, but can doesn’t always mean should.

Ain’t gastroenteritis grand?

The Grand Canyon is perhaps America’s greatest natural wonder. The mile-deep gorge of epic proportions, carved over eons by the Colorado River, elicits superlatives of the highest order from those seeing it for the first time. In the past few months, though, visitors to the Grand Canyon have been experiencing a rather more unpleasant sort of reaction: Involuntary bowel evacuation.

Since April, more than 150 river rafters and backcountry campers have fallen ill with bouts of acute gastroenteritis, likely caused by norovirus. Hey, a viral outbreak and our old friend SARS-CoV-2 isn’t involved! Hopefully it won’t get jealous. Whatever the culprit is, however, it got everywhere, as clusters of illness have popped up in unconnected parts of the park and some hikers have been restricted to a smaller portion of the park to avoid further disease spread. The majority of cases occurred in May, so it’s hoped that the outbreak is dying down, but the park remains on alert.

Jon Sullivan/Pixnio

Now, acute gastroenteritis is certainly an unpleasant disease, but it isn’t typically a life-threatening one. There are, however, a couple of unique factors complicating this outbreak. For one, the Grand Canyon is in Arizona (duh), which can get rather hot in the summer months. Expelling waste from both ends becomes rather more dangerous when the thermometer reads over a hundred degrees, and there have been reports of multiple helicopter rescues.

That’s pretty bad, but in a way, they’re the lucky ones. How can we explain this … see, when you visit the Grand Canyon, you’re expected to follow the general rules of Leave No Trace. That means several things, but essentially, if you bring it in, you have to bring it out. Yes, that includes the various consequences of an acute gastroenteritis attack.

Forget spooky campfire stories and hungry wildlife lurking in the night, because true horror is scraping your friend’s diarrhea off the walls of the Grand Canyon into a plastic bag and stuffing it into your backpack. Probably not the sublime one-on-one Grand Canyon experience that people are expecting.
 

Give us a pee! ... for stem cell retrieval

Getting cells for regenerative stem cell treatment has traditionally been painful and difficult – usually they are retrieved by surgical means from bone marrow or fat tissue – but there may be an easier way.

Just pee in a cup.

toeytoey2530/Thinkstock

Apparently, human urine contains stem cells with the potential to be used for regenerative effects. The magic ingredient? The enzyme telomerase, which “is essential for the self-renewal and potential of different types of stem cells” and is related to longevity, according to researchers at Wake Forest Institute for Regenerative Medicine.

They looked into how regenerative telomerase activity is for various capabilities beyond chromosomal stability, and whether these stem cells can become other kinds of cells for optimal tissue repair. Turns out they could, acting as a “distinct subpopulation” that has the ability not only to grow cells but also to morph into other cells, they said in a written statement.

Safety is also an issue. “Being able to use a patient’s own stem cells for therapy is considered advantageous because they do not induce immune responses or rejection,” said Anthony Atala, MD, a coauthor of the study published in Frontiers in Cell and Developmental Biology.

So less risk, easier retrieval, and great regenerative results. If this takes off, the other methods of retrieval could get flushed down the toilet.
 

Politicians playing the long game, literally

Before we get started with actual information, here’s a joke about politicians:

What do you call a lawyer with an IQ of 100? Your Honor.

What do you call a lawyer with an IQ of 50? Senator.

Politics is a dirty business, no doubt, so why do people do it? Is it for the prestige? Seems like everyone hates politicians, so it’s probably not that. Is it their selfless concern for the well-being of others? Probably not that either. Is it for the money? Most members of Congress have more corporate sponsors than a NASCAR driver, but we’re going to pass on that one as well.

Phi Nguyen/House of Representatives

Once again, science gives us the real answer: Longevity. Politicians live longer than the rest of us, and that longevity gap is getting wider.

Investigators looked at data from 11 industrialized countries, some of it going back to 1817, and found that politicians in the United States can expect to live about 7 years longer than the national average. The difference is around 3 years in Switzerland, 4.5 years in Germany, and 6 years in France.

“For almost all countries, politicians had similar rates of mortality to the general population in the late 19th and early 20th centuries. Throughout the 20th century, differences in mortality rates widened significantly across all countries, so that politicians had an increasing survival advantage over the general population,” they said in a written statement.

Income inequality could be a factor, but the longevity gains made by politicians, which started before the 1940s, predate the rise of their earnings relative to the rest of the population, which didn’t really get going until the 1980s, the investigators noted.

Whatever the reason, we have this closing thought regarding our long-lived lawmakers: What’s the difference between a politician and a snail? One is a slimy pest that leaves a trail everywhere. The other is a snail.
 

Land of the free, home of obesity

In the United States, it seems, people are becoming more comfortable with obesity. TikTok and Instagram trends often try to show the world that all sizes are beautiful. There’s also the growing popularity of the dad bod.

PxHere

America, it has been said, is the land of the free. We love our freedom, and we value our individualism. If an obese man orders three meals from McDonald’s just for himself, no one is going to stop him. Many Americans also have more access to the food they want at any given time, even while they are moving around a lot less because of their sedentary lifestyles.

According to a recent study cited by the New York Post, however, America is not the only country battling obesity. Egypt and Mexico, for example, also have men with higher BMIs who cherish their individualism and the right to eat what they want, Plamen Akaliyski, PhD, of University Carlos III of Madrid, and associates, said in Social Science & Medicine.

Women are not as likely to think the same way. “Men in particular think, ‘I’m an individual, don’t tell me what to do. I’m going to eat what I want,’ ” bariatric surgeon George A. Fielding, MD, said in the Post article. Dr. Fielding also noted that women are three times more likely than men to seek bariatric surgery.

Dr. Akaliyski and associates found that Asian countries such as Japan, Singapore, and South Korea – countries that value thrift, discipline, self control, and delaying gratification – have lower rates of obesity.

So yes, we can go to the drive through of a fast food restaurant whenever we want and order whatever we want, but can doesn’t always mean should.

As states ban or limit abortion in the wake of the demise of Roe v. Wade, physicians are turning their attention to widely-used drugs that can cause birth defects. At issue: Should these drugs still be prescribed to women of childbearing age if they don’t have the option of terminating their pregnancies?

javi_indy/ Thinkstock

“Doctors are going to understandably be terrified that a patient may become pregnant using a teratogen that they have prescribed,” said University of Pittsburgh rheumatologist Mehret Birru Talabi, MD, PhD, who works in a state where the future of abortion rights is uncertain. “While this was a feared outcome before Roe v. Wade was overturned, abortion provided an escape hatch by which women could avoid having to continue a pregnancy and potentially raise a child with congenital anomalies. I believe that prescribing is going to become much more defensive and conservative. Some clinicians may choose not to prescribe these medications to patients who have childbearing potential, even if they don’t have much risk for pregnancy.”

Other physicians expressed similar concerns in interviews. Duke University, Durham, N.C., rheumatologist Megan E. B. Clowse, MD, MPH, fears that physicians will be wary of prescribing a variety of medications – including new ones for which there are few pregnancy data – if abortion is unavailable. “Women who receive these new or teratogenic medications will likely lose their reproductive autonomy and be forced to choose between having sexual relationships with men, obtaining procedures that make them permanently sterile, or using contraception that may cause intolerable side effects,” she said. “I am very concerned that young women with rheumatic disease will now be left with active disease resulting in joint damage and renal failure.”

Abortion is now banned in at least six states, according to The New York Times. That number may rise to 16 as more restrictions become law. Another five states aren’t expected to ban abortion soon but have implemented gestational age limits on abortion or are expected to adopt them. In another nine states, courts or lawmakers will decide whether abortion remains legal.

Only 20 states and the District of Columbia have firm abortion protections in place.

Numerous drugs are considered teratogens, which means they may cause birth defects. Thalidomide is the most infamous, but there are many more, including several used in rheumatology, dermatology, and gastroenterology. Among the most widely used teratogenic medications are the acne drugs isotretinoin and methotrexate, which are used to treat a variety of conditions, such as cancer, rheumatoid arthritis, and psoriasis.

Dr. Clowse, who helps manage an industry-supported website devoted to reproductive care for women with lupus (www.LupusPregnancy.org), noted that several drugs linked to birth defects and pregnancy loss are commonly prescribed in rheumatology.

“Methotrexate is the most common medication and has been the cornerstone of rheumatoid arthritis [treatment] for at least two decades,” she said. “Mycophenolate is our best medication to treat lupus nephritis, which is inflammation in the kidneys caused by lupus. This is a common complication for young women with lupus, and all of our guideline-recommended treatment regimens include a medication that causes pregnancy loss and birth defects, either mycophenolate or cyclophosphamide.”

Rheumatologists also prescribe a large number of new drugs for which there are few data about pregnancy risks. “It typically takes about two decades to have sufficient data about the safety of our medications,” she said.

Reflecting the sensitivity of the topic, Dr. Clowse made clear that her opinions don’t represent the views of her institution. She works in North Carolina, where the fate of abortion rights is uncertain, according to The New York Times.

What about alternatives? “The short answer is that some of these medications work really well and sometimes much better than the nonteratogenic alternatives,” said Dr. Birru Talabi. “I’m worried about methotrexate. It has been used to induce abortions but is primarily used in the United States as a highly effective treatment for cancer as well as a myriad of rheumatic diseases. If legislators try to restrict access to methotrexate, we may see increasing disability and even death among people who need this medication but cannot access it.”

Rheumatologists aren’t the only physicians who are worrying about the fates of their patients in a new era of abortion restrictions. Gastroenterologist Sunanda Kane, MD, MSPH, of the Mayo Clinic, Rochester, Minn., said several teratogenic medications are used in her field to treat constipation, viral hepatitis, and inflammatory bowel disease.

“When treating women of childbearing age, there are usually alternatives. If we do prescribe a medication with a high teratogenic potential, we counsel and document that we have discussed two forms of birth control to avoid pregnancy. We usually do not prescribe a drug with teratogenic potential with the ‘out’ being an abortion if a pregnancy does occur,” she said. However, “if abortion is not even on the table as an option, we may be much less likely to prescribe these medications. This will be particularly true in patients who clearly do not have the means to travel to have an abortion in any situation.”

Abortion is expected to remain legal in Minnesota, where Dr. Kane practices, but it may be restricted or banned in nearby Wisconsin, depending on the state legislature. None of her patients have had abortions after becoming pregnant while taking the medications, she said, although she “did have a patient who because of her religious faith did not have an abortion after exposure and ended up with a stillbirth.”

The crackdown on abortion won’t just pose risks to patients who take potentially dangerous medications, physicians said. Dr. Kane said pregnancy itself is a significant risk for patients with “very active, uncontrolled gastrointestinal conditions where a pregnancy could be harmful to the mother’s health or result in offspring that are very unhealthy.” These include decompensated cirrhosis, uncontrolled Crohn’s disease or ulcerative colitis, refractory gastroparesis, uncontrolled celiac sprue, and chronic pancreatitis, she said.

“There have been times when after shared decisionmaking, a patient with very active inflammatory bowel disease has decided to terminate the pregnancy because of her own ongoing health issues,” she said. “Not having this option will potentially lead to disastrous results.”

Dr. Clowse, the Duke University rheumatologist, echoed Dr. Kane’s concerns about women who are too sick to bear children. “The removal of abortion rights puts the lives and quality of life for women with rheumatic disease at risk. For patients with lupus and other systemic rheumatic disease, pregnancy can be medically catastrophic, leading to permanent harm and even death to the woman and her offspring. I am worried that women in these conditions will die without lifesaving pregnancy terminations, due to worries about the legal consequences for their physicians.”

The U.S. Supreme Court’s ruling that overturned Roe v. Wade has also raised the prospect that the court could ultimately allow birth control to be restricted or outlawed.

While the ruling states that “nothing in this opinion should be understood to cast doubt on precedents that do not concern abortion,” Justice Clarence Thomas wrote a concurrence in which he said that the court should reconsider a 1960s ruling that forbids the banning of contraceptives. Republicans have dismissed concerns about bans being allowed, although Democrats, including the president and vice president, starkly warn that they could happen.

“If we as providers have to be concerned that there will be an unplanned pregnancy because of the lack of access to contraception,” Dr. Kane said, “this will have significant downstream consequences to the kind of care we can provide and might just drive some providers to not give care to female patients at all given this concern.”

The physicians quoted in this article report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

As states ban or limit abortion in the wake of the demise of Roe v. Wade, physicians are turning their attention to widely-used drugs that can cause birth defects. At issue: Should these drugs still be prescribed to women of childbearing age if they don’t have the option of terminating their pregnancies?

javi_indy/ Thinkstock

“Doctors are going to understandably be terrified that a patient may become pregnant using a teratogen that they have prescribed,” said University of Pittsburgh rheumatologist Mehret Birru Talabi, MD, PhD, who works in a state where the future of abortion rights is uncertain. “While this was a feared outcome before Roe v. Wade was overturned, abortion provided an escape hatch by which women could avoid having to continue a pregnancy and potentially raise a child with congenital anomalies. I believe that prescribing is going to become much more defensive and conservative. Some clinicians may choose not to prescribe these medications to patients who have childbearing potential, even if they don’t have much risk for pregnancy.”

Other physicians expressed similar concerns in interviews. Duke University, Durham, N.C., rheumatologist Megan E. B. Clowse, MD, MPH, fears that physicians will be wary of prescribing a variety of medications – including new ones for which there are few pregnancy data – if abortion is unavailable. “Women who receive these new or teratogenic medications will likely lose their reproductive autonomy and be forced to choose between having sexual relationships with men, obtaining procedures that make them permanently sterile, or using contraception that may cause intolerable side effects,” she said. “I am very concerned that young women with rheumatic disease will now be left with active disease resulting in joint damage and renal failure.”

Abortion is now banned in at least six states, according to The New York Times. That number may rise to 16 as more restrictions become law. Another five states aren’t expected to ban abortion soon but have implemented gestational age limits on abortion or are expected to adopt them. In another nine states, courts or lawmakers will decide whether abortion remains legal.

Only 20 states and the District of Columbia have firm abortion protections in place.

Numerous drugs are considered teratogens, which means they may cause birth defects. Thalidomide is the most infamous, but there are many more, including several used in rheumatology, dermatology, and gastroenterology. Among the most widely used teratogenic medications are the acne drugs isotretinoin and methotrexate, which are used to treat a variety of conditions, such as cancer, rheumatoid arthritis, and psoriasis.

Dr. Clowse, who helps manage an industry-supported website devoted to reproductive care for women with lupus (www.LupusPregnancy.org), noted that several drugs linked to birth defects and pregnancy loss are commonly prescribed in rheumatology.

“Methotrexate is the most common medication and has been the cornerstone of rheumatoid arthritis [treatment] for at least two decades,” she said. “Mycophenolate is our best medication to treat lupus nephritis, which is inflammation in the kidneys caused by lupus. This is a common complication for young women with lupus, and all of our guideline-recommended treatment regimens include a medication that causes pregnancy loss and birth defects, either mycophenolate or cyclophosphamide.”

Rheumatologists also prescribe a large number of new drugs for which there are few data about pregnancy risks. “It typically takes about two decades to have sufficient data about the safety of our medications,” she said.

Reflecting the sensitivity of the topic, Dr. Clowse made clear that her opinions don’t represent the views of her institution. She works in North Carolina, where the fate of abortion rights is uncertain, according to The New York Times.

What about alternatives? “The short answer is that some of these medications work really well and sometimes much better than the nonteratogenic alternatives,” said Dr. Birru Talabi. “I’m worried about methotrexate. It has been used to induce abortions but is primarily used in the United States as a highly effective treatment for cancer as well as a myriad of rheumatic diseases. If legislators try to restrict access to methotrexate, we may see increasing disability and even death among people who need this medication but cannot access it.”

Rheumatologists aren’t the only physicians who are worrying about the fates of their patients in a new era of abortion restrictions. Gastroenterologist Sunanda Kane, MD, MSPH, of the Mayo Clinic, Rochester, Minn., said several teratogenic medications are used in her field to treat constipation, viral hepatitis, and inflammatory bowel disease.

“When treating women of childbearing age, there are usually alternatives. If we do prescribe a medication with a high teratogenic potential, we counsel and document that we have discussed two forms of birth control to avoid pregnancy. We usually do not prescribe a drug with teratogenic potential with the ‘out’ being an abortion if a pregnancy does occur,” she said. However, “if abortion is not even on the table as an option, we may be much less likely to prescribe these medications. This will be particularly true in patients who clearly do not have the means to travel to have an abortion in any situation.”

Abortion is expected to remain legal in Minnesota, where Dr. Kane practices, but it may be restricted or banned in nearby Wisconsin, depending on the state legislature. None of her patients have had abortions after becoming pregnant while taking the medications, she said, although she “did have a patient who because of her religious faith did not have an abortion after exposure and ended up with a stillbirth.”

The crackdown on abortion won’t just pose risks to patients who take potentially dangerous medications, physicians said. Dr. Kane said pregnancy itself is a significant risk for patients with “very active, uncontrolled gastrointestinal conditions where a pregnancy could be harmful to the mother’s health or result in offspring that are very unhealthy.” These include decompensated cirrhosis, uncontrolled Crohn’s disease or ulcerative colitis, refractory gastroparesis, uncontrolled celiac sprue, and chronic pancreatitis, she said.

“There have been times when after shared decisionmaking, a patient with very active inflammatory bowel disease has decided to terminate the pregnancy because of her own ongoing health issues,” she said. “Not having this option will potentially lead to disastrous results.”

Dr. Clowse, the Duke University rheumatologist, echoed Dr. Kane’s concerns about women who are too sick to bear children. “The removal of abortion rights puts the lives and quality of life for women with rheumatic disease at risk. For patients with lupus and other systemic rheumatic disease, pregnancy can be medically catastrophic, leading to permanent harm and even death to the woman and her offspring. I am worried that women in these conditions will die without lifesaving pregnancy terminations, due to worries about the legal consequences for their physicians.”

The U.S. Supreme Court’s ruling that overturned Roe v. Wade has also raised the prospect that the court could ultimately allow birth control to be restricted or outlawed.

While the ruling states that “nothing in this opinion should be understood to cast doubt on precedents that do not concern abortion,” Justice Clarence Thomas wrote a concurrence in which he said that the court should reconsider a 1960s ruling that forbids the banning of contraceptives. Republicans have dismissed concerns about bans being allowed, although Democrats, including the president and vice president, starkly warn that they could happen.

“If we as providers have to be concerned that there will be an unplanned pregnancy because of the lack of access to contraception,” Dr. Kane said, “this will have significant downstream consequences to the kind of care we can provide and might just drive some providers to not give care to female patients at all given this concern.”

The physicians quoted in this article report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

As states ban or limit abortion in the wake of the demise of Roe v. Wade, physicians are turning their attention to widely-used drugs that can cause birth defects. At issue: Should these drugs still be prescribed to women of childbearing age if they don’t have the option of terminating their pregnancies?

javi_indy/ Thinkstock

“Doctors are going to understandably be terrified that a patient may become pregnant using a teratogen that they have prescribed,” said University of Pittsburgh rheumatologist Mehret Birru Talabi, MD, PhD, who works in a state where the future of abortion rights is uncertain. “While this was a feared outcome before Roe v. Wade was overturned, abortion provided an escape hatch by which women could avoid having to continue a pregnancy and potentially raise a child with congenital anomalies. I believe that prescribing is going to become much more defensive and conservative. Some clinicians may choose not to prescribe these medications to patients who have childbearing potential, even if they don’t have much risk for pregnancy.”

Other physicians expressed similar concerns in interviews. Duke University, Durham, N.C., rheumatologist Megan E. B. Clowse, MD, MPH, fears that physicians will be wary of prescribing a variety of medications – including new ones for which there are few pregnancy data – if abortion is unavailable. “Women who receive these new or teratogenic medications will likely lose their reproductive autonomy and be forced to choose between having sexual relationships with men, obtaining procedures that make them permanently sterile, or using contraception that may cause intolerable side effects,” she said. “I am very concerned that young women with rheumatic disease will now be left with active disease resulting in joint damage and renal failure.”

Abortion is now banned in at least six states, according to The New York Times. That number may rise to 16 as more restrictions become law. Another five states aren’t expected to ban abortion soon but have implemented gestational age limits on abortion or are expected to adopt them. In another nine states, courts or lawmakers will decide whether abortion remains legal.

Only 20 states and the District of Columbia have firm abortion protections in place.

Numerous drugs are considered teratogens, which means they may cause birth defects. Thalidomide is the most infamous, but there are many more, including several used in rheumatology, dermatology, and gastroenterology. Among the most widely used teratogenic medications are the acne drugs isotretinoin and methotrexate, which are used to treat a variety of conditions, such as cancer, rheumatoid arthritis, and psoriasis.

Dr. Clowse, who helps manage an industry-supported website devoted to reproductive care for women with lupus (www.LupusPregnancy.org), noted that several drugs linked to birth defects and pregnancy loss are commonly prescribed in rheumatology.

“Methotrexate is the most common medication and has been the cornerstone of rheumatoid arthritis [treatment] for at least two decades,” she said. “Mycophenolate is our best medication to treat lupus nephritis, which is inflammation in the kidneys caused by lupus. This is a common complication for young women with lupus, and all of our guideline-recommended treatment regimens include a medication that causes pregnancy loss and birth defects, either mycophenolate or cyclophosphamide.”

Rheumatologists also prescribe a large number of new drugs for which there are few data about pregnancy risks. “It typically takes about two decades to have sufficient data about the safety of our medications,” she said.

Reflecting the sensitivity of the topic, Dr. Clowse made clear that her opinions don’t represent the views of her institution. She works in North Carolina, where the fate of abortion rights is uncertain, according to The New York Times.

What about alternatives? “The short answer is that some of these medications work really well and sometimes much better than the nonteratogenic alternatives,” said Dr. Birru Talabi. “I’m worried about methotrexate. It has been used to induce abortions but is primarily used in the United States as a highly effective treatment for cancer as well as a myriad of rheumatic diseases. If legislators try to restrict access to methotrexate, we may see increasing disability and even death among people who need this medication but cannot access it.”

Rheumatologists aren’t the only physicians who are worrying about the fates of their patients in a new era of abortion restrictions. Gastroenterologist Sunanda Kane, MD, MSPH, of the Mayo Clinic, Rochester, Minn., said several teratogenic medications are used in her field to treat constipation, viral hepatitis, and inflammatory bowel disease.

“When treating women of childbearing age, there are usually alternatives. If we do prescribe a medication with a high teratogenic potential, we counsel and document that we have discussed two forms of birth control to avoid pregnancy. We usually do not prescribe a drug with teratogenic potential with the ‘out’ being an abortion if a pregnancy does occur,” she said. However, “if abortion is not even on the table as an option, we may be much less likely to prescribe these medications. This will be particularly true in patients who clearly do not have the means to travel to have an abortion in any situation.”

Abortion is expected to remain legal in Minnesota, where Dr. Kane practices, but it may be restricted or banned in nearby Wisconsin, depending on the state legislature. None of her patients have had abortions after becoming pregnant while taking the medications, she said, although she “did have a patient who because of her religious faith did not have an abortion after exposure and ended up with a stillbirth.”

The crackdown on abortion won’t just pose risks to patients who take potentially dangerous medications, physicians said. Dr. Kane said pregnancy itself is a significant risk for patients with “very active, uncontrolled gastrointestinal conditions where a pregnancy could be harmful to the mother’s health or result in offspring that are very unhealthy.” These include decompensated cirrhosis, uncontrolled Crohn’s disease or ulcerative colitis, refractory gastroparesis, uncontrolled celiac sprue, and chronic pancreatitis, she said.

“There have been times when after shared decisionmaking, a patient with very active inflammatory bowel disease has decided to terminate the pregnancy because of her own ongoing health issues,” she said. “Not having this option will potentially lead to disastrous results.”

Dr. Clowse, the Duke University rheumatologist, echoed Dr. Kane’s concerns about women who are too sick to bear children. “The removal of abortion rights puts the lives and quality of life for women with rheumatic disease at risk. For patients with lupus and other systemic rheumatic disease, pregnancy can be medically catastrophic, leading to permanent harm and even death to the woman and her offspring. I am worried that women in these conditions will die without lifesaving pregnancy terminations, due to worries about the legal consequences for their physicians.”

The U.S. Supreme Court’s ruling that overturned Roe v. Wade has also raised the prospect that the court could ultimately allow birth control to be restricted or outlawed.

While the ruling states that “nothing in this opinion should be understood to cast doubt on precedents that do not concern abortion,” Justice Clarence Thomas wrote a concurrence in which he said that the court should reconsider a 1960s ruling that forbids the banning of contraceptives. Republicans have dismissed concerns about bans being allowed, although Democrats, including the president and vice president, starkly warn that they could happen.

“If we as providers have to be concerned that there will be an unplanned pregnancy because of the lack of access to contraception,” Dr. Kane said, “this will have significant downstream consequences to the kind of care we can provide and might just drive some providers to not give care to female patients at all given this concern.”

The physicians quoted in this article report no relevant financial relationships.

A version of this article first appeared on Medscape.com.

The White House is scaling up its response to the monkeypox outbreak, expanding access to vaccines to more at-risk individuals, officials said in a press call. More than 56,000 doses of the monkeypox vaccine JYNNEOS will be made available immediately, and more than 240,000 doses will be allocated in the coming weeks.

“The administration’s current strategy is focused on containing the outbreak by providing vaccines to those most in need to prevent further spread of monkeypox in the communities most impacted,” CDC Director Rochelle Walensky, MD, MPH, said on a June 28 press call. “As additional supply becomes available, we will further expand our efforts making vaccines available to a wider population.”

As of June 28, there were 4,700 detected cases of monkeypox globally in 49 countries. Since the first U.S. case of monkeypox was identified on May 17, there have been 306 confirmed cases across 28 jurisdictions.

Prior to this announcement, vaccination against monkeypox was recommended only for people with known exposures to the virus. Now, the vaccine is available to people who are likely to be exposed to the virus, including:

• People who have had close physical contact with someone diagnosed with monkeypox.
• People with a sexual partner diagnosed with monkeypox.
• Men who have sex with men who have had multiple sex partners in a venue where monkeypox was identified.

The JYNNEOS vaccine is administered in two doses, delivered 28 days apart. People will have maximum immunity 2 weeks after the second dose. People should be vaccinated within 2 weeks of a possible monkeypox exposure, Dr. Walensky said, adding, “The sooner you can get vaccinated after exposure, the better.”

The U.S. Department of Health and Human Services will immediately allocate the 56,000 JYNNEOS doses across the country, prioritizing jurisdictions to areas of high transmission. A second vaccine, ACAM2000, can also be requested, but it has a greater risk for serious side effects and is not appropriate for immunocompromised individuals or people with heart disease. In the coming weeks, 240,000 JYNNEOS doses will be made available for second doses as well as first doses “as the vaccine strategy broadens,” said David Boucher, director of infectious disease preparedness and response for HHS. There are currently 800,000 JYNNEOS doses that have been manufactured and approved for release, he said, and awaiting inspection by the Food and Drug Administration, which should be completed in the beginning of July.

At the same time, the administration is focusing on increasing access to testing. Monkeypox testing is now available in 78 state public health labs in 48 states that can collectively conduct 10,000 tests per week. In addition, the administration announced on June 23 that HHS began shipping monkeypox tests to five commercial lab companies to expand testing capacity as well as make testing more accessible.

“We continue to work very closely with the community and with public health partners and clinicians to increase awareness of the monkey pox outbreak and to facilitate adequate capacity and equitable access to testing,” Dr. Walensky said. “I strongly encourage all health care providers to have a high clinical suspicion for monkeypox among their patients. Patients presenting with a suspicious rash should be tested.”

A version of this article first appeared on Medscape.com.

The White House is scaling up its response to the monkeypox outbreak, expanding access to vaccines to more at-risk individuals, officials said in a press call. More than 56,000 doses of the monkeypox vaccine JYNNEOS will be made available immediately, and more than 240,000 doses will be allocated in the coming weeks.

“The administration’s current strategy is focused on containing the outbreak by providing vaccines to those most in need to prevent further spread of monkeypox in the communities most impacted,” CDC Director Rochelle Walensky, MD, MPH, said on a June 28 press call. “As additional supply becomes available, we will further expand our efforts making vaccines available to a wider population.”

As of June 28, there were 4,700 detected cases of monkeypox globally in 49 countries. Since the first U.S. case of monkeypox was identified on May 17, there have been 306 confirmed cases across 28 jurisdictions.

Prior to this announcement, vaccination against monkeypox was recommended only for people with known exposures to the virus. Now, the vaccine is available to people who are likely to be exposed to the virus, including:

• People who have had close physical contact with someone diagnosed with monkeypox.
• People with a sexual partner diagnosed with monkeypox.
• Men who have sex with men who have had multiple sex partners in a venue where monkeypox was identified.

The JYNNEOS vaccine is administered in two doses, delivered 28 days apart. People will have maximum immunity 2 weeks after the second dose. People should be vaccinated within 2 weeks of a possible monkeypox exposure, Dr. Walensky said, adding, “The sooner you can get vaccinated after exposure, the better.”

The U.S. Department of Health and Human Services will immediately allocate the 56,000 JYNNEOS doses across the country, prioritizing jurisdictions to areas of high transmission. A second vaccine, ACAM2000, can also be requested, but it has a greater risk for serious side effects and is not appropriate for immunocompromised individuals or people with heart disease. In the coming weeks, 240,000 JYNNEOS doses will be made available for second doses as well as first doses “as the vaccine strategy broadens,” said David Boucher, director of infectious disease preparedness and response for HHS. There are currently 800,000 JYNNEOS doses that have been manufactured and approved for release, he said, and awaiting inspection by the Food and Drug Administration, which should be completed in the beginning of July.

At the same time, the administration is focusing on increasing access to testing. Monkeypox testing is now available in 78 state public health labs in 48 states that can collectively conduct 10,000 tests per week. In addition, the administration announced on June 23 that HHS began shipping monkeypox tests to five commercial lab companies to expand testing capacity as well as make testing more accessible.

“We continue to work very closely with the community and with public health partners and clinicians to increase awareness of the monkey pox outbreak and to facilitate adequate capacity and equitable access to testing,” Dr. Walensky said. “I strongly encourage all health care providers to have a high clinical suspicion for monkeypox among their patients. Patients presenting with a suspicious rash should be tested.”

A version of this article first appeared on Medscape.com.

The White House is scaling up its response to the monkeypox outbreak, expanding access to vaccines to more at-risk individuals, officials said in a press call. More than 56,000 doses of the monkeypox vaccine JYNNEOS will be made available immediately, and more than 240,000 doses will be allocated in the coming weeks.

“The administration’s current strategy is focused on containing the outbreak by providing vaccines to those most in need to prevent further spread of monkeypox in the communities most impacted,” CDC Director Rochelle Walensky, MD, MPH, said on a June 28 press call. “As additional supply becomes available, we will further expand our efforts making vaccines available to a wider population.”

As of June 28, there were 4,700 detected cases of monkeypox globally in 49 countries. Since the first U.S. case of monkeypox was identified on May 17, there have been 306 confirmed cases across 28 jurisdictions.

Prior to this announcement, vaccination against monkeypox was recommended only for people with known exposures to the virus. Now, the vaccine is available to people who are likely to be exposed to the virus, including:

• People who have had close physical contact with someone diagnosed with monkeypox.
• People with a sexual partner diagnosed with monkeypox.
• Men who have sex with men who have had multiple sex partners in a venue where monkeypox was identified.

The JYNNEOS vaccine is administered in two doses, delivered 28 days apart. People will have maximum immunity 2 weeks after the second dose. People should be vaccinated within 2 weeks of a possible monkeypox exposure, Dr. Walensky said, adding, “The sooner you can get vaccinated after exposure, the better.”

The U.S. Department of Health and Human Services will immediately allocate the 56,000 JYNNEOS doses across the country, prioritizing jurisdictions to areas of high transmission. A second vaccine, ACAM2000, can also be requested, but it has a greater risk for serious side effects and is not appropriate for immunocompromised individuals or people with heart disease. In the coming weeks, 240,000 JYNNEOS doses will be made available for second doses as well as first doses “as the vaccine strategy broadens,” said David Boucher, director of infectious disease preparedness and response for HHS. There are currently 800,000 JYNNEOS doses that have been manufactured and approved for release, he said, and awaiting inspection by the Food and Drug Administration, which should be completed in the beginning of July.

At the same time, the administration is focusing on increasing access to testing. Monkeypox testing is now available in 78 state public health labs in 48 states that can collectively conduct 10,000 tests per week. In addition, the administration announced on June 23 that HHS began shipping monkeypox tests to five commercial lab companies to expand testing capacity as well as make testing more accessible.

“We continue to work very closely with the community and with public health partners and clinicians to increase awareness of the monkey pox outbreak and to facilitate adequate capacity and equitable access to testing,” Dr. Walensky said. “I strongly encourage all health care providers to have a high clinical suspicion for monkeypox among their patients. Patients presenting with a suspicious rash should be tested.”

A version of this article first appeared on Medscape.com.