Marathon running does not increase arthritis risk: Survey

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Changed
Thu, 03/23/2023 - 08:45

Long-distance runners are often warned that they are wearing out their joints, but a new study found that running mileage, frequency, and pace were not associated with an increased risk of osteoarthritis.

Runners who had undergone knee or hip surgery or had a previous hip or knee injury that prevented running were most likely to have arthritis, researchers found. Family history of arthritis, higher body mass index (BMI), and older age were also associated with increased risk of the condition.

The study was presented at the American Academy of Orthopaedic Surgeons 2023 Annual Meeting.

It has generally been thought that running may increase risk of osteoarthritis because it puts more load on joints than walking or standing, noted Grace Hsiao-Wei Lo, MD, an assistant professor of immunology, allergy, and rheumatology at the Baylor College of Medicine, Houston, who was not involved with the work. Research in this area has yielded mixed results: A 2017 analysis of multiple studies found that competitive runners did have higher rates of arthritis than recreational runners, while another study conducted by Dr. Lo found that runners did not have an increased risk of knee osteoarthritis, compared with nonrunners. A 2018 study showed that marathon runners had lower instances of arthritis, compared with the general population.

In this new study, researchers surveyed 3,804 runners who participated in the 2019 or 2021 Chicago Marathon about their running history, average mileage per week, and average running pace. The survey also asked about known risk factors for osteoarthritis, including BMI, family history of arthritis, and past knee and hip injuries that prevented running.

Runners, on average, were about 44 years old and ran 27.9 miles per week. The largest proportion of respondents had completed 2-5 marathons (37.3%), around 21% of respondents had finished 6-10 marathons, and 17% were running their first marathon. Study participants had an average of 15 years of running experience, 1,892 reported a previous hip or knee injury, and 413 had undergone knee or hip surgery. Overall, 36.4% reported experiencing hip or knee pain in the past year, and 7.3% had been diagnosed with arthritis.

Researchers found that there was no association between the risk of osteoarthritis and weekly mileage, years spent running, number of marathons completed, or running pace. Respondents who had undergone knee or hip surgery had the highest risk of osteoarthritis (odds ratio, 5.85; P < .0001), followed by those with a history of knee or hip injuries that prevented running (OR, 5.04; P < .0001). Other identified risk factors were family history of arthritis (OR, 3.47; P < .0001), BMI (OR, 1.10; P < .0001), and older age (OR, 1.08; P < .0001).

The news should be encouraging for runners, said Matthew Hartwell, MD, an orthopedic surgeon at the University of California, San Francisco, who led the research. If someone does not have injuries or surgeries that keep them from running, “you can still continue to run,” he said. “There may not necessarily be this dose-response relationship where the more you run, the more you break down your knee or your hip.”

Still, 24.2% of runners reported that their physician had advised them to reduce their mileage or stop running altogether. Most runners (94.2%) said they planned to run another marathon.

“The results of this study are consistent with the experiences of many lifelong runners and observations of sports medicine professionals that osteoarthritis is not an inevitable consequence of distance running,” said Brett Toresdahl, MD, a sports medicine physician at the Hospital for Special Surgery in New York, who was not involved with the study.

Still, he emphasized that more research is necessary to understand whether running contributes to the risk of developing osteoarthritis. The participants in the study were current marathoners, he noted, so it is likely they have healthy joints that can tolerate running longer distances. “If there is a subset of people who have joints that are negatively affected by running, they wouldn’t likely be registering for a marathon,” he said in an email interview.

Dr. Lo added that comparing these marathoners to a group who did not run would help assess whether running can be harmful to joints. “To be fair, this is a challenging subject to study,” she said. “Osteoarthritis has a long natural history, and so it is difficult to evaluate this kind of question over many years of running and many years of evaluation of arthritis.”

While the research does not answer the question of whether running can lead to osteoarthritis, it helps show the need for long-term research on how running affects joints over time as well as one’s general health, Dr. Toresdahl noted. “I would not be surprised if future longitudinal research will come to the same conclusion that running for the majority of patients is a net benefit for overall health and at least net neutral for joint health when done in moderation,” he said.

Dr. Hartwell, Dr. Lo, and Dr. Toresdahl report no relevant financial relationships.

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

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Long-distance runners are often warned that they are wearing out their joints, but a new study found that running mileage, frequency, and pace were not associated with an increased risk of osteoarthritis.

Runners who had undergone knee or hip surgery or had a previous hip or knee injury that prevented running were most likely to have arthritis, researchers found. Family history of arthritis, higher body mass index (BMI), and older age were also associated with increased risk of the condition.

The study was presented at the American Academy of Orthopaedic Surgeons 2023 Annual Meeting.

It has generally been thought that running may increase risk of osteoarthritis because it puts more load on joints than walking or standing, noted Grace Hsiao-Wei Lo, MD, an assistant professor of immunology, allergy, and rheumatology at the Baylor College of Medicine, Houston, who was not involved with the work. Research in this area has yielded mixed results: A 2017 analysis of multiple studies found that competitive runners did have higher rates of arthritis than recreational runners, while another study conducted by Dr. Lo found that runners did not have an increased risk of knee osteoarthritis, compared with nonrunners. A 2018 study showed that marathon runners had lower instances of arthritis, compared with the general population.

In this new study, researchers surveyed 3,804 runners who participated in the 2019 or 2021 Chicago Marathon about their running history, average mileage per week, and average running pace. The survey also asked about known risk factors for osteoarthritis, including BMI, family history of arthritis, and past knee and hip injuries that prevented running.

Runners, on average, were about 44 years old and ran 27.9 miles per week. The largest proportion of respondents had completed 2-5 marathons (37.3%), around 21% of respondents had finished 6-10 marathons, and 17% were running their first marathon. Study participants had an average of 15 years of running experience, 1,892 reported a previous hip or knee injury, and 413 had undergone knee or hip surgery. Overall, 36.4% reported experiencing hip or knee pain in the past year, and 7.3% had been diagnosed with arthritis.

Researchers found that there was no association between the risk of osteoarthritis and weekly mileage, years spent running, number of marathons completed, or running pace. Respondents who had undergone knee or hip surgery had the highest risk of osteoarthritis (odds ratio, 5.85; P < .0001), followed by those with a history of knee or hip injuries that prevented running (OR, 5.04; P < .0001). Other identified risk factors were family history of arthritis (OR, 3.47; P < .0001), BMI (OR, 1.10; P < .0001), and older age (OR, 1.08; P < .0001).

The news should be encouraging for runners, said Matthew Hartwell, MD, an orthopedic surgeon at the University of California, San Francisco, who led the research. If someone does not have injuries or surgeries that keep them from running, “you can still continue to run,” he said. “There may not necessarily be this dose-response relationship where the more you run, the more you break down your knee or your hip.”

Still, 24.2% of runners reported that their physician had advised them to reduce their mileage or stop running altogether. Most runners (94.2%) said they planned to run another marathon.

“The results of this study are consistent with the experiences of many lifelong runners and observations of sports medicine professionals that osteoarthritis is not an inevitable consequence of distance running,” said Brett Toresdahl, MD, a sports medicine physician at the Hospital for Special Surgery in New York, who was not involved with the study.

Still, he emphasized that more research is necessary to understand whether running contributes to the risk of developing osteoarthritis. The participants in the study were current marathoners, he noted, so it is likely they have healthy joints that can tolerate running longer distances. “If there is a subset of people who have joints that are negatively affected by running, they wouldn’t likely be registering for a marathon,” he said in an email interview.

Dr. Lo added that comparing these marathoners to a group who did not run would help assess whether running can be harmful to joints. “To be fair, this is a challenging subject to study,” she said. “Osteoarthritis has a long natural history, and so it is difficult to evaluate this kind of question over many years of running and many years of evaluation of arthritis.”

While the research does not answer the question of whether running can lead to osteoarthritis, it helps show the need for long-term research on how running affects joints over time as well as one’s general health, Dr. Toresdahl noted. “I would not be surprised if future longitudinal research will come to the same conclusion that running for the majority of patients is a net benefit for overall health and at least net neutral for joint health when done in moderation,” he said.

Dr. Hartwell, Dr. Lo, and Dr. Toresdahl report no relevant financial relationships.

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

Long-distance runners are often warned that they are wearing out their joints, but a new study found that running mileage, frequency, and pace were not associated with an increased risk of osteoarthritis.

Runners who had undergone knee or hip surgery or had a previous hip or knee injury that prevented running were most likely to have arthritis, researchers found. Family history of arthritis, higher body mass index (BMI), and older age were also associated with increased risk of the condition.

The study was presented at the American Academy of Orthopaedic Surgeons 2023 Annual Meeting.

It has generally been thought that running may increase risk of osteoarthritis because it puts more load on joints than walking or standing, noted Grace Hsiao-Wei Lo, MD, an assistant professor of immunology, allergy, and rheumatology at the Baylor College of Medicine, Houston, who was not involved with the work. Research in this area has yielded mixed results: A 2017 analysis of multiple studies found that competitive runners did have higher rates of arthritis than recreational runners, while another study conducted by Dr. Lo found that runners did not have an increased risk of knee osteoarthritis, compared with nonrunners. A 2018 study showed that marathon runners had lower instances of arthritis, compared with the general population.

In this new study, researchers surveyed 3,804 runners who participated in the 2019 or 2021 Chicago Marathon about their running history, average mileage per week, and average running pace. The survey also asked about known risk factors for osteoarthritis, including BMI, family history of arthritis, and past knee and hip injuries that prevented running.

Runners, on average, were about 44 years old and ran 27.9 miles per week. The largest proportion of respondents had completed 2-5 marathons (37.3%), around 21% of respondents had finished 6-10 marathons, and 17% were running their first marathon. Study participants had an average of 15 years of running experience, 1,892 reported a previous hip or knee injury, and 413 had undergone knee or hip surgery. Overall, 36.4% reported experiencing hip or knee pain in the past year, and 7.3% had been diagnosed with arthritis.

Researchers found that there was no association between the risk of osteoarthritis and weekly mileage, years spent running, number of marathons completed, or running pace. Respondents who had undergone knee or hip surgery had the highest risk of osteoarthritis (odds ratio, 5.85; P < .0001), followed by those with a history of knee or hip injuries that prevented running (OR, 5.04; P < .0001). Other identified risk factors were family history of arthritis (OR, 3.47; P < .0001), BMI (OR, 1.10; P < .0001), and older age (OR, 1.08; P < .0001).

The news should be encouraging for runners, said Matthew Hartwell, MD, an orthopedic surgeon at the University of California, San Francisco, who led the research. If someone does not have injuries or surgeries that keep them from running, “you can still continue to run,” he said. “There may not necessarily be this dose-response relationship where the more you run, the more you break down your knee or your hip.”

Still, 24.2% of runners reported that their physician had advised them to reduce their mileage or stop running altogether. Most runners (94.2%) said they planned to run another marathon.

“The results of this study are consistent with the experiences of many lifelong runners and observations of sports medicine professionals that osteoarthritis is not an inevitable consequence of distance running,” said Brett Toresdahl, MD, a sports medicine physician at the Hospital for Special Surgery in New York, who was not involved with the study.

Still, he emphasized that more research is necessary to understand whether running contributes to the risk of developing osteoarthritis. The participants in the study were current marathoners, he noted, so it is likely they have healthy joints that can tolerate running longer distances. “If there is a subset of people who have joints that are negatively affected by running, they wouldn’t likely be registering for a marathon,” he said in an email interview.

Dr. Lo added that comparing these marathoners to a group who did not run would help assess whether running can be harmful to joints. “To be fair, this is a challenging subject to study,” she said. “Osteoarthritis has a long natural history, and so it is difficult to evaluate this kind of question over many years of running and many years of evaluation of arthritis.”

While the research does not answer the question of whether running can lead to osteoarthritis, it helps show the need for long-term research on how running affects joints over time as well as one’s general health, Dr. Toresdahl noted. “I would not be surprised if future longitudinal research will come to the same conclusion that running for the majority of patients is a net benefit for overall health and at least net neutral for joint health when done in moderation,” he said.

Dr. Hartwell, Dr. Lo, and Dr. Toresdahl report no relevant financial relationships.

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

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Opioid overdose is an important cause of postpartum death

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Thu, 03/16/2023 - 12:41

Opioid overdose and other preventable causes are important contributors to postpartum death rates, Medicaid claims data show, particularly in women who have a recent history of opioid use disorder (OUD), according to research published in Obstetrics and Gynecology.

Opioid overdose deaths account for up to 10% of pregnancy-associated deaths in the United States, and 75% of the deliveries of women with OUD are covered by Medicaid, according to lead author Elizabeth Suarez, PhD, MPH, with the division of pharmacoepidemiology and pharmacoeconomics at Brigham and Women’s Hospital and Harvard Medical School in Boston, and colleagues.
 

Nearly 5 million deliveries studied

Researchers studied claims data from Medicaid and the National Death Index database in the United States from 2006 to 2013 for 4,972,061 deliveries. They also identified a subgroup of women with a documented history of OUD in the 3 months before delivery.

They found the incidence of postpartum opioid overdose deaths was 5.4 per 100,000 deliveries (95% confidence interval, 4.5-6.4) among all in the study and 118 per 100,000 (95% CI, 84-163) among individuals with OUD.

Incidence of all-cause postpartum death was six times higher in women with OUD than in all the women studied. Common causes of death of those with OUD were other drug- and alcohol-related deaths (47/100,000); suicide (26/100,000); and other injuries, including accidents and falls (33/100,000).

Risk factors strongly linked with postpartum opioid overdose death included mental health and other substance use disorders.
 

Medication significantly lowers death risk

The authors also documented the benefit of buprenorphine or methadone for OUD.

For women with OUD who used medication to treat OUD post partum, odds of opioid overdose death were 60% lower (odds ratio, 0.4; 95% CI 0.1-0.9).

As important as use of medication, Marcela Smid, MD, MS, writes in an accompanying editorial, is noting that 80% of the women in this study who died of opioid overdoses had contact with a health care provider before death.

“Both of these results indicate that we have the means and opportunity to prevent these deaths,” writes Dr. Smid, with the division of maternal fetal medicine, University of Utah Health in Salt Lake City.
 

Dismal numbers on ob.gyns. trained to prescribe medications

She points out some barriers, however. Most clinicians, she notes, lack time and training to prescribe buprenorphine, and in 2019, fewer than 2% of ob.gyns. who accept Medicaid were able to prescribe it.

Her charge to ob.gyns.: “We need to help identify individuals who are at high risk of OUD or opioid overdose by screening.” A validated screening tool should be used at prenatal and postpartum appointments.

On a bigger scale, she urges Medicaid to be expanded for a full year post partum through the American Rescue Act’s State Plan Amendment, something only 28 states and Washington, D.C., have done so far.

Dr. Smid points out some good news, however: President Joe Biden signed the Consolidated Appropriations Act 2023, which eliminated the “X” waiver.

Now all clinicians who have a Drug Enforcement Administration registration that includes Schedule III authority can prescribe buprenorphine for OUD if applicable state law allows it.

But that calls for medical schools and residency programs to prioritize addiction medicine as a core competency, Dr. Smid says.
 

 

 

Getting naloxone to patients, families

One of the potential interventions the study authors suggest is providing naloxone prescriptions and training to pregnant and postpartum women who have a substance use history and to their partners and significant others.

However, Mishka Terplan, MD, MPH, told this publication, “It’s one thing to write a prescription; it’s another thing for the person to actually get the medication.” He is medical director of the Friends Research Institute in Baltimore, an ob.gyn. who specializes in addiction medicine.

“What can we do?” We can think about how to get naloxone into people’s hands at discharge from the hospital after they give birth, instead of prescribing. That would mean that health systems need to prioritize this, he said. “We give people discharge medications all the time.”

Still, naloxone can’t be seen as the answer, he said.

He compares it to defibrillators in public places, which are for rescues, not reversing a population problem.

“Some people think that naloxone reversals are doing something about OUD. It’s doing about as much about OUD as defibrillators do for cardiovascular disease,” he said.

The best help, he says, will be continuation of treatment.

“Addiction is a chronic condition,” he says, “but often we only provide episodic care. We see that particularly in pregnancy. Once the pregnancy is finished, there’s not categorical continuation of insurance.”

Even if you do have insurance, it’s hard to find a clinic that’s family friendly, he notes. “You might not feel comfortable taking your newborn and standing in line in the morning to get your daily methodone dose. We have to make those environments more welcoming.”
 

Problem probably understated

He also says that though the study was well done given the data available, he’s frustrated that researchers still have to depend on billing data and can’t capture factors such as child care availability, living wages, and continuation of health insurance. Additionally, not everyone is coded correctly for OUD.

“It’s all Medicaid, so it’s only people who continued with care,” he pointed out. That means these numbers may actually underrepresent the problem.

Still, he says it’s important to realize the magnitude of deaths this study does highlight in this population.

In people with OUD in the postpartum period, the deaths are more than 1 in 1,000.

“That should be alarming,” Dr. Terplan said. “That’s a very big number from a public health perspective.”

Coauthor Kathryn J. Gray received payment from Aetion Inc., Roche, and BillionToOne. Funds were paid to the University of Utah for Dr. Smid from Alydia Inc. for being the site principal investigator for a study of the JADA device, and from Gilead for Dr. Smid’s study of hepatitis C in pregnancy; she was also a consultant for Organon and Rhia Ventures. Dr. Terplan reports no relevant financial relationships.
 

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Opioid overdose and other preventable causes are important contributors to postpartum death rates, Medicaid claims data show, particularly in women who have a recent history of opioid use disorder (OUD), according to research published in Obstetrics and Gynecology.

Opioid overdose deaths account for up to 10% of pregnancy-associated deaths in the United States, and 75% of the deliveries of women with OUD are covered by Medicaid, according to lead author Elizabeth Suarez, PhD, MPH, with the division of pharmacoepidemiology and pharmacoeconomics at Brigham and Women’s Hospital and Harvard Medical School in Boston, and colleagues.
 

Nearly 5 million deliveries studied

Researchers studied claims data from Medicaid and the National Death Index database in the United States from 2006 to 2013 for 4,972,061 deliveries. They also identified a subgroup of women with a documented history of OUD in the 3 months before delivery.

They found the incidence of postpartum opioid overdose deaths was 5.4 per 100,000 deliveries (95% confidence interval, 4.5-6.4) among all in the study and 118 per 100,000 (95% CI, 84-163) among individuals with OUD.

Incidence of all-cause postpartum death was six times higher in women with OUD than in all the women studied. Common causes of death of those with OUD were other drug- and alcohol-related deaths (47/100,000); suicide (26/100,000); and other injuries, including accidents and falls (33/100,000).

Risk factors strongly linked with postpartum opioid overdose death included mental health and other substance use disorders.
 

Medication significantly lowers death risk

The authors also documented the benefit of buprenorphine or methadone for OUD.

For women with OUD who used medication to treat OUD post partum, odds of opioid overdose death were 60% lower (odds ratio, 0.4; 95% CI 0.1-0.9).

As important as use of medication, Marcela Smid, MD, MS, writes in an accompanying editorial, is noting that 80% of the women in this study who died of opioid overdoses had contact with a health care provider before death.

“Both of these results indicate that we have the means and opportunity to prevent these deaths,” writes Dr. Smid, with the division of maternal fetal medicine, University of Utah Health in Salt Lake City.
 

Dismal numbers on ob.gyns. trained to prescribe medications

She points out some barriers, however. Most clinicians, she notes, lack time and training to prescribe buprenorphine, and in 2019, fewer than 2% of ob.gyns. who accept Medicaid were able to prescribe it.

Her charge to ob.gyns.: “We need to help identify individuals who are at high risk of OUD or opioid overdose by screening.” A validated screening tool should be used at prenatal and postpartum appointments.

On a bigger scale, she urges Medicaid to be expanded for a full year post partum through the American Rescue Act’s State Plan Amendment, something only 28 states and Washington, D.C., have done so far.

Dr. Smid points out some good news, however: President Joe Biden signed the Consolidated Appropriations Act 2023, which eliminated the “X” waiver.

Now all clinicians who have a Drug Enforcement Administration registration that includes Schedule III authority can prescribe buprenorphine for OUD if applicable state law allows it.

But that calls for medical schools and residency programs to prioritize addiction medicine as a core competency, Dr. Smid says.
 

 

 

Getting naloxone to patients, families

One of the potential interventions the study authors suggest is providing naloxone prescriptions and training to pregnant and postpartum women who have a substance use history and to their partners and significant others.

However, Mishka Terplan, MD, MPH, told this publication, “It’s one thing to write a prescription; it’s another thing for the person to actually get the medication.” He is medical director of the Friends Research Institute in Baltimore, an ob.gyn. who specializes in addiction medicine.

“What can we do?” We can think about how to get naloxone into people’s hands at discharge from the hospital after they give birth, instead of prescribing. That would mean that health systems need to prioritize this, he said. “We give people discharge medications all the time.”

Still, naloxone can’t be seen as the answer, he said.

He compares it to defibrillators in public places, which are for rescues, not reversing a population problem.

“Some people think that naloxone reversals are doing something about OUD. It’s doing about as much about OUD as defibrillators do for cardiovascular disease,” he said.

The best help, he says, will be continuation of treatment.

“Addiction is a chronic condition,” he says, “but often we only provide episodic care. We see that particularly in pregnancy. Once the pregnancy is finished, there’s not categorical continuation of insurance.”

Even if you do have insurance, it’s hard to find a clinic that’s family friendly, he notes. “You might not feel comfortable taking your newborn and standing in line in the morning to get your daily methodone dose. We have to make those environments more welcoming.”
 

Problem probably understated

He also says that though the study was well done given the data available, he’s frustrated that researchers still have to depend on billing data and can’t capture factors such as child care availability, living wages, and continuation of health insurance. Additionally, not everyone is coded correctly for OUD.

“It’s all Medicaid, so it’s only people who continued with care,” he pointed out. That means these numbers may actually underrepresent the problem.

Still, he says it’s important to realize the magnitude of deaths this study does highlight in this population.

In people with OUD in the postpartum period, the deaths are more than 1 in 1,000.

“That should be alarming,” Dr. Terplan said. “That’s a very big number from a public health perspective.”

Coauthor Kathryn J. Gray received payment from Aetion Inc., Roche, and BillionToOne. Funds were paid to the University of Utah for Dr. Smid from Alydia Inc. for being the site principal investigator for a study of the JADA device, and from Gilead for Dr. Smid’s study of hepatitis C in pregnancy; she was also a consultant for Organon and Rhia Ventures. Dr. Terplan reports no relevant financial relationships.
 

Opioid overdose and other preventable causes are important contributors to postpartum death rates, Medicaid claims data show, particularly in women who have a recent history of opioid use disorder (OUD), according to research published in Obstetrics and Gynecology.

Opioid overdose deaths account for up to 10% of pregnancy-associated deaths in the United States, and 75% of the deliveries of women with OUD are covered by Medicaid, according to lead author Elizabeth Suarez, PhD, MPH, with the division of pharmacoepidemiology and pharmacoeconomics at Brigham and Women’s Hospital and Harvard Medical School in Boston, and colleagues.
 

Nearly 5 million deliveries studied

Researchers studied claims data from Medicaid and the National Death Index database in the United States from 2006 to 2013 for 4,972,061 deliveries. They also identified a subgroup of women with a documented history of OUD in the 3 months before delivery.

They found the incidence of postpartum opioid overdose deaths was 5.4 per 100,000 deliveries (95% confidence interval, 4.5-6.4) among all in the study and 118 per 100,000 (95% CI, 84-163) among individuals with OUD.

Incidence of all-cause postpartum death was six times higher in women with OUD than in all the women studied. Common causes of death of those with OUD were other drug- and alcohol-related deaths (47/100,000); suicide (26/100,000); and other injuries, including accidents and falls (33/100,000).

Risk factors strongly linked with postpartum opioid overdose death included mental health and other substance use disorders.
 

Medication significantly lowers death risk

The authors also documented the benefit of buprenorphine or methadone for OUD.

For women with OUD who used medication to treat OUD post partum, odds of opioid overdose death were 60% lower (odds ratio, 0.4; 95% CI 0.1-0.9).

As important as use of medication, Marcela Smid, MD, MS, writes in an accompanying editorial, is noting that 80% of the women in this study who died of opioid overdoses had contact with a health care provider before death.

“Both of these results indicate that we have the means and opportunity to prevent these deaths,” writes Dr. Smid, with the division of maternal fetal medicine, University of Utah Health in Salt Lake City.
 

Dismal numbers on ob.gyns. trained to prescribe medications

She points out some barriers, however. Most clinicians, she notes, lack time and training to prescribe buprenorphine, and in 2019, fewer than 2% of ob.gyns. who accept Medicaid were able to prescribe it.

Her charge to ob.gyns.: “We need to help identify individuals who are at high risk of OUD or opioid overdose by screening.” A validated screening tool should be used at prenatal and postpartum appointments.

On a bigger scale, she urges Medicaid to be expanded for a full year post partum through the American Rescue Act’s State Plan Amendment, something only 28 states and Washington, D.C., have done so far.

Dr. Smid points out some good news, however: President Joe Biden signed the Consolidated Appropriations Act 2023, which eliminated the “X” waiver.

Now all clinicians who have a Drug Enforcement Administration registration that includes Schedule III authority can prescribe buprenorphine for OUD if applicable state law allows it.

But that calls for medical schools and residency programs to prioritize addiction medicine as a core competency, Dr. Smid says.
 

 

 

Getting naloxone to patients, families

One of the potential interventions the study authors suggest is providing naloxone prescriptions and training to pregnant and postpartum women who have a substance use history and to their partners and significant others.

However, Mishka Terplan, MD, MPH, told this publication, “It’s one thing to write a prescription; it’s another thing for the person to actually get the medication.” He is medical director of the Friends Research Institute in Baltimore, an ob.gyn. who specializes in addiction medicine.

“What can we do?” We can think about how to get naloxone into people’s hands at discharge from the hospital after they give birth, instead of prescribing. That would mean that health systems need to prioritize this, he said. “We give people discharge medications all the time.”

Still, naloxone can’t be seen as the answer, he said.

He compares it to defibrillators in public places, which are for rescues, not reversing a population problem.

“Some people think that naloxone reversals are doing something about OUD. It’s doing about as much about OUD as defibrillators do for cardiovascular disease,” he said.

The best help, he says, will be continuation of treatment.

“Addiction is a chronic condition,” he says, “but often we only provide episodic care. We see that particularly in pregnancy. Once the pregnancy is finished, there’s not categorical continuation of insurance.”

Even if you do have insurance, it’s hard to find a clinic that’s family friendly, he notes. “You might not feel comfortable taking your newborn and standing in line in the morning to get your daily methodone dose. We have to make those environments more welcoming.”
 

Problem probably understated

He also says that though the study was well done given the data available, he’s frustrated that researchers still have to depend on billing data and can’t capture factors such as child care availability, living wages, and continuation of health insurance. Additionally, not everyone is coded correctly for OUD.

“It’s all Medicaid, so it’s only people who continued with care,” he pointed out. That means these numbers may actually underrepresent the problem.

Still, he says it’s important to realize the magnitude of deaths this study does highlight in this population.

In people with OUD in the postpartum period, the deaths are more than 1 in 1,000.

“That should be alarming,” Dr. Terplan said. “That’s a very big number from a public health perspective.”

Coauthor Kathryn J. Gray received payment from Aetion Inc., Roche, and BillionToOne. Funds were paid to the University of Utah for Dr. Smid from Alydia Inc. for being the site principal investigator for a study of the JADA device, and from Gilead for Dr. Smid’s study of hepatitis C in pregnancy; she was also a consultant for Organon and Rhia Ventures. Dr. Terplan reports no relevant financial relationships.
 

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Buprenorphine proves effective for fentanyl users in the ED

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Fri, 03/10/2023 - 14:20

 

Response to buprenorphine among emergency department patients using fentanyl was similar to that in patients using other opioids, based on data from nearly 900 individuals.

California EDs include a facilitation program known as CA Bridge for the treatment of opioid use disorder. Guidelines for CA Bridge call for high-dose buprenorphine to treat patients in drug withdrawal, with doses starting at 8-16 mg, Hannah Snyder, MD, of the University of California, San Francisco, and colleagues wrote.

“Buprenorphine has been repeatedly shown to save lives and prevent overdoses,” Dr. Snyder said in an interview. “We know that emergency department–initiated buprenorphine is an essential tool for increasing access. In the era of fentanyl, both patients and providers have expressed concerns that buprenorphine may not work as well as it did when patients were more likely to be using heroin or opioid pills.

“This retrospective cohort study provides additional information about emergency department buprenorphine as fentanyl becomes increasingly prevalent.” 

In a research letter published in JAMA Network Open, the investigators reviewed data from the electronic health records of 896 patients who presented with opioid use disorder (OUD) at 16 CA Bridge EDs between Jan. 1, 2020, and April 30, 2020. All patients with OUD were included regardless of chief concern, current treatment, treatment desires, or withdrawal. A total of 87 individuals reported fentanyl use; if no fentanyl use was reported, the patient was classified as not using fentanyl. The median age of the patients was 35 years, two thirds were male, approximately 46% were White and non-Hispanic, and 30% had unstable housing.

The primary outcome was follow-up engagement at 7-14 days and 25-37 days.

A total of 492 patients received buprenorphine, including 44 fentanyl users, and 439 initiated high doses of 8-32 mg. At a 30-day follow-up, eight patients had precipitated withdrawal, including two cases in fentanyl users; none of these cases required hospital admission.

The follow-up engagement was similar for both groups, with adjusted odds ratios of 0.60 for administered buprenorphine at the initial ED encounter, 1.09 for 7-day follow-up, and 1.33 for 30-day follow-up.

The findings were limited by the retrospective design and use of clinical documentation, which likely resulted in underreporting of fentanyl use and follow-up, the researchers noted. However, the results supported the effectiveness of buprenorphine for ED patients in withdrawal with a history of fentanyl exposure.

“We were pleased to see that precipitated withdrawal was relatively uncommon in this study, and that patients who did and did not use fentanyl followed up at similar rates,” said Dr. Snyder. “This aligns with our clinical experience and prior research showing that emergency department buprenorphine starts continue to be an essential tool.”

The message for clinicians: “If a patient presents to the emergency department in objective opioid withdrawal and desires buprenorphine, they should be offered treatment in that moment,” Dr. Snyder said. “Treatment protocols used by hospitals in this study are available online. Emergency departments can offer compassionate and evidence-based treatment initiation 24 hours a day, 7 days a week, 365 days a year.”
 

More data needed on dosing strategies

“We need additional research to determine best practices for patients who use fentanyl and want to start buprenorphine, but are not yet in withdrawal,” Dr. Snyder said. “Doses of buprenorphine like those in this study are only appropriate for patients who are in withdrawal with objective signs, so some patients may struggle to wait long enough after their last use to go into sufficient withdrawal.”

Precipitated withdrawal does occur in some cases, said Dr. Snyder. “If it does, the emergency department is a very good place to manage it. We need additional research to determine best practices in management to make patients as comfortable as possible, including additional high-dose buprenorphine as well as additional adjunctive agents.”
 

Findings support buprenorphine

“The classic approach to buprenorphine initiation, which emerged from psychiatry outpatient office visits, is to start with very small doses of buprenorphine [2-4 mg] and titrate up slowly,” Reuben J. Strayer, MD, said in an interview.

“This dose range turns out to be the ‘sour spot’ most likely to cause the most important complication around buprenorphine initiation–precipitated withdrawal,” said Dr. Strayer, the director of addiction medicine in the emergency medicine department at Maimonides Medical Center, New York.

“One of the current focus areas of OUD treatment research is determining how to initiate buprenorphine without entailing a period of spontaneous withdrawal and without causing precipitated withdrawal,” Strayer explained. “The two primary strategies are low-dose buprenorphine initiation [LDBI, less than 2 mg, sometimes called microdosing] and high-dose [HDBI, ≥ 16 mg] buprenorphine initiation. HDBI is attractive because the primary treatment of buprenorphine-precipitated withdrawal is more buprenorphine.

“Additionally, using a high dose up front immediately transitions the patient to therapeutic blood levels, which protects the patient from withdrawal, cravings, and overdose from dangerous opioids (heroin, fentanyl, oxycodone).”

However, “the contamination and now replacement of heroin with fentanyl in the street drug supply has challenged buprenorphine initiation, because fentanyl, when used chronically, accumulates in the body and leaks into the bloodstream slowly over time, preventing the opioid washout that is required to eliminate the risk of precipitated withdrawal when buprenorphine is administered,” said Dr. Strayer.

The current study demonstrates that patients who are initiated with a first dose of 8-16 mg buprenorphine are unlikely to experience precipitated withdrawal and are successfully transitioned to buprenorphine maintenance and clinic follow-up, Dr. Snyder said, but he was surprised by the low rate of precipitated withdrawal in the current study, “which is discordant with what is being anecdotally reported across the country.”

However, the take-home message for clinicians is the support for the initiation of buprenorphine in emergency department settings at a starting dose of 8-16 mg, regardless of reported fentanyl use, he said. “Given the huge impact buprenorphine therapy has on OUD-related mortality, clinicians should make every effort to initiate buprenorphine for OUD patients at every opportunity, and precipitated withdrawal is very unlikely in appropriately selected patients.

“Many clinicians remain reluctant to initiate buprenorphine in ED settings for unfamiliarity with the drug, fear of precipitated withdrawal, or concerns around the certainty of outpatient follow-up,” Dr. Snyder said. “Education, encouragement, systems programming, such as including decision support within the electronic health record, and role-modeling from local champions will promote wider adoption of this lifesaving practice.”

Looking ahead, “more research, including prospective research, is needed to refine best practices around buprenorphine administration,” said Dr. Snyder. Questions to address include which patients are most at risk for precipitated withdrawal and whether there are alternatives to standard initiation dosing that are sufficiently unlikely to cause precipitated withdrawal. “Possibly effective alternatives include buprenorphine initiation by administration of long-acting injectable depot buprenorphine, which accumulates slowly, potentially avoiding precipitated withdrawal, as well as a slow intravenous buprenorphine infusion such as 9 mg given over 12 hours.”

The study received no outside funding. Dr. Snyder disclosed grants from the Substance Abuse and Mental Health Services Administration and the California Department of Health Care Services during the study. Dr. Strayer reported no relevant financial relationships.

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

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Response to buprenorphine among emergency department patients using fentanyl was similar to that in patients using other opioids, based on data from nearly 900 individuals.

California EDs include a facilitation program known as CA Bridge for the treatment of opioid use disorder. Guidelines for CA Bridge call for high-dose buprenorphine to treat patients in drug withdrawal, with doses starting at 8-16 mg, Hannah Snyder, MD, of the University of California, San Francisco, and colleagues wrote.

“Buprenorphine has been repeatedly shown to save lives and prevent overdoses,” Dr. Snyder said in an interview. “We know that emergency department–initiated buprenorphine is an essential tool for increasing access. In the era of fentanyl, both patients and providers have expressed concerns that buprenorphine may not work as well as it did when patients were more likely to be using heroin or opioid pills.

“This retrospective cohort study provides additional information about emergency department buprenorphine as fentanyl becomes increasingly prevalent.” 

In a research letter published in JAMA Network Open, the investigators reviewed data from the electronic health records of 896 patients who presented with opioid use disorder (OUD) at 16 CA Bridge EDs between Jan. 1, 2020, and April 30, 2020. All patients with OUD were included regardless of chief concern, current treatment, treatment desires, or withdrawal. A total of 87 individuals reported fentanyl use; if no fentanyl use was reported, the patient was classified as not using fentanyl. The median age of the patients was 35 years, two thirds were male, approximately 46% were White and non-Hispanic, and 30% had unstable housing.

The primary outcome was follow-up engagement at 7-14 days and 25-37 days.

A total of 492 patients received buprenorphine, including 44 fentanyl users, and 439 initiated high doses of 8-32 mg. At a 30-day follow-up, eight patients had precipitated withdrawal, including two cases in fentanyl users; none of these cases required hospital admission.

The follow-up engagement was similar for both groups, with adjusted odds ratios of 0.60 for administered buprenorphine at the initial ED encounter, 1.09 for 7-day follow-up, and 1.33 for 30-day follow-up.

The findings were limited by the retrospective design and use of clinical documentation, which likely resulted in underreporting of fentanyl use and follow-up, the researchers noted. However, the results supported the effectiveness of buprenorphine for ED patients in withdrawal with a history of fentanyl exposure.

“We were pleased to see that precipitated withdrawal was relatively uncommon in this study, and that patients who did and did not use fentanyl followed up at similar rates,” said Dr. Snyder. “This aligns with our clinical experience and prior research showing that emergency department buprenorphine starts continue to be an essential tool.”

The message for clinicians: “If a patient presents to the emergency department in objective opioid withdrawal and desires buprenorphine, they should be offered treatment in that moment,” Dr. Snyder said. “Treatment protocols used by hospitals in this study are available online. Emergency departments can offer compassionate and evidence-based treatment initiation 24 hours a day, 7 days a week, 365 days a year.”
 

More data needed on dosing strategies

“We need additional research to determine best practices for patients who use fentanyl and want to start buprenorphine, but are not yet in withdrawal,” Dr. Snyder said. “Doses of buprenorphine like those in this study are only appropriate for patients who are in withdrawal with objective signs, so some patients may struggle to wait long enough after their last use to go into sufficient withdrawal.”

Precipitated withdrawal does occur in some cases, said Dr. Snyder. “If it does, the emergency department is a very good place to manage it. We need additional research to determine best practices in management to make patients as comfortable as possible, including additional high-dose buprenorphine as well as additional adjunctive agents.”
 

Findings support buprenorphine

“The classic approach to buprenorphine initiation, which emerged from psychiatry outpatient office visits, is to start with very small doses of buprenorphine [2-4 mg] and titrate up slowly,” Reuben J. Strayer, MD, said in an interview.

“This dose range turns out to be the ‘sour spot’ most likely to cause the most important complication around buprenorphine initiation–precipitated withdrawal,” said Dr. Strayer, the director of addiction medicine in the emergency medicine department at Maimonides Medical Center, New York.

“One of the current focus areas of OUD treatment research is determining how to initiate buprenorphine without entailing a period of spontaneous withdrawal and without causing precipitated withdrawal,” Strayer explained. “The two primary strategies are low-dose buprenorphine initiation [LDBI, less than 2 mg, sometimes called microdosing] and high-dose [HDBI, ≥ 16 mg] buprenorphine initiation. HDBI is attractive because the primary treatment of buprenorphine-precipitated withdrawal is more buprenorphine.

“Additionally, using a high dose up front immediately transitions the patient to therapeutic blood levels, which protects the patient from withdrawal, cravings, and overdose from dangerous opioids (heroin, fentanyl, oxycodone).”

However, “the contamination and now replacement of heroin with fentanyl in the street drug supply has challenged buprenorphine initiation, because fentanyl, when used chronically, accumulates in the body and leaks into the bloodstream slowly over time, preventing the opioid washout that is required to eliminate the risk of precipitated withdrawal when buprenorphine is administered,” said Dr. Strayer.

The current study demonstrates that patients who are initiated with a first dose of 8-16 mg buprenorphine are unlikely to experience precipitated withdrawal and are successfully transitioned to buprenorphine maintenance and clinic follow-up, Dr. Snyder said, but he was surprised by the low rate of precipitated withdrawal in the current study, “which is discordant with what is being anecdotally reported across the country.”

However, the take-home message for clinicians is the support for the initiation of buprenorphine in emergency department settings at a starting dose of 8-16 mg, regardless of reported fentanyl use, he said. “Given the huge impact buprenorphine therapy has on OUD-related mortality, clinicians should make every effort to initiate buprenorphine for OUD patients at every opportunity, and precipitated withdrawal is very unlikely in appropriately selected patients.

“Many clinicians remain reluctant to initiate buprenorphine in ED settings for unfamiliarity with the drug, fear of precipitated withdrawal, or concerns around the certainty of outpatient follow-up,” Dr. Snyder said. “Education, encouragement, systems programming, such as including decision support within the electronic health record, and role-modeling from local champions will promote wider adoption of this lifesaving practice.”

Looking ahead, “more research, including prospective research, is needed to refine best practices around buprenorphine administration,” said Dr. Snyder. Questions to address include which patients are most at risk for precipitated withdrawal and whether there are alternatives to standard initiation dosing that are sufficiently unlikely to cause precipitated withdrawal. “Possibly effective alternatives include buprenorphine initiation by administration of long-acting injectable depot buprenorphine, which accumulates slowly, potentially avoiding precipitated withdrawal, as well as a slow intravenous buprenorphine infusion such as 9 mg given over 12 hours.”

The study received no outside funding. Dr. Snyder disclosed grants from the Substance Abuse and Mental Health Services Administration and the California Department of Health Care Services during the study. Dr. Strayer reported no relevant financial relationships.

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

 

Response to buprenorphine among emergency department patients using fentanyl was similar to that in patients using other opioids, based on data from nearly 900 individuals.

California EDs include a facilitation program known as CA Bridge for the treatment of opioid use disorder. Guidelines for CA Bridge call for high-dose buprenorphine to treat patients in drug withdrawal, with doses starting at 8-16 mg, Hannah Snyder, MD, of the University of California, San Francisco, and colleagues wrote.

“Buprenorphine has been repeatedly shown to save lives and prevent overdoses,” Dr. Snyder said in an interview. “We know that emergency department–initiated buprenorphine is an essential tool for increasing access. In the era of fentanyl, both patients and providers have expressed concerns that buprenorphine may not work as well as it did when patients were more likely to be using heroin or opioid pills.

“This retrospective cohort study provides additional information about emergency department buprenorphine as fentanyl becomes increasingly prevalent.” 

In a research letter published in JAMA Network Open, the investigators reviewed data from the electronic health records of 896 patients who presented with opioid use disorder (OUD) at 16 CA Bridge EDs between Jan. 1, 2020, and April 30, 2020. All patients with OUD were included regardless of chief concern, current treatment, treatment desires, or withdrawal. A total of 87 individuals reported fentanyl use; if no fentanyl use was reported, the patient was classified as not using fentanyl. The median age of the patients was 35 years, two thirds were male, approximately 46% were White and non-Hispanic, and 30% had unstable housing.

The primary outcome was follow-up engagement at 7-14 days and 25-37 days.

A total of 492 patients received buprenorphine, including 44 fentanyl users, and 439 initiated high doses of 8-32 mg. At a 30-day follow-up, eight patients had precipitated withdrawal, including two cases in fentanyl users; none of these cases required hospital admission.

The follow-up engagement was similar for both groups, with adjusted odds ratios of 0.60 for administered buprenorphine at the initial ED encounter, 1.09 for 7-day follow-up, and 1.33 for 30-day follow-up.

The findings were limited by the retrospective design and use of clinical documentation, which likely resulted in underreporting of fentanyl use and follow-up, the researchers noted. However, the results supported the effectiveness of buprenorphine for ED patients in withdrawal with a history of fentanyl exposure.

“We were pleased to see that precipitated withdrawal was relatively uncommon in this study, and that patients who did and did not use fentanyl followed up at similar rates,” said Dr. Snyder. “This aligns with our clinical experience and prior research showing that emergency department buprenorphine starts continue to be an essential tool.”

The message for clinicians: “If a patient presents to the emergency department in objective opioid withdrawal and desires buprenorphine, they should be offered treatment in that moment,” Dr. Snyder said. “Treatment protocols used by hospitals in this study are available online. Emergency departments can offer compassionate and evidence-based treatment initiation 24 hours a day, 7 days a week, 365 days a year.”
 

More data needed on dosing strategies

“We need additional research to determine best practices for patients who use fentanyl and want to start buprenorphine, but are not yet in withdrawal,” Dr. Snyder said. “Doses of buprenorphine like those in this study are only appropriate for patients who are in withdrawal with objective signs, so some patients may struggle to wait long enough after their last use to go into sufficient withdrawal.”

Precipitated withdrawal does occur in some cases, said Dr. Snyder. “If it does, the emergency department is a very good place to manage it. We need additional research to determine best practices in management to make patients as comfortable as possible, including additional high-dose buprenorphine as well as additional adjunctive agents.”
 

Findings support buprenorphine

“The classic approach to buprenorphine initiation, which emerged from psychiatry outpatient office visits, is to start with very small doses of buprenorphine [2-4 mg] and titrate up slowly,” Reuben J. Strayer, MD, said in an interview.

“This dose range turns out to be the ‘sour spot’ most likely to cause the most important complication around buprenorphine initiation–precipitated withdrawal,” said Dr. Strayer, the director of addiction medicine in the emergency medicine department at Maimonides Medical Center, New York.

“One of the current focus areas of OUD treatment research is determining how to initiate buprenorphine without entailing a period of spontaneous withdrawal and without causing precipitated withdrawal,” Strayer explained. “The two primary strategies are low-dose buprenorphine initiation [LDBI, less than 2 mg, sometimes called microdosing] and high-dose [HDBI, ≥ 16 mg] buprenorphine initiation. HDBI is attractive because the primary treatment of buprenorphine-precipitated withdrawal is more buprenorphine.

“Additionally, using a high dose up front immediately transitions the patient to therapeutic blood levels, which protects the patient from withdrawal, cravings, and overdose from dangerous opioids (heroin, fentanyl, oxycodone).”

However, “the contamination and now replacement of heroin with fentanyl in the street drug supply has challenged buprenorphine initiation, because fentanyl, when used chronically, accumulates in the body and leaks into the bloodstream slowly over time, preventing the opioid washout that is required to eliminate the risk of precipitated withdrawal when buprenorphine is administered,” said Dr. Strayer.

The current study demonstrates that patients who are initiated with a first dose of 8-16 mg buprenorphine are unlikely to experience precipitated withdrawal and are successfully transitioned to buprenorphine maintenance and clinic follow-up, Dr. Snyder said, but he was surprised by the low rate of precipitated withdrawal in the current study, “which is discordant with what is being anecdotally reported across the country.”

However, the take-home message for clinicians is the support for the initiation of buprenorphine in emergency department settings at a starting dose of 8-16 mg, regardless of reported fentanyl use, he said. “Given the huge impact buprenorphine therapy has on OUD-related mortality, clinicians should make every effort to initiate buprenorphine for OUD patients at every opportunity, and precipitated withdrawal is very unlikely in appropriately selected patients.

“Many clinicians remain reluctant to initiate buprenorphine in ED settings for unfamiliarity with the drug, fear of precipitated withdrawal, or concerns around the certainty of outpatient follow-up,” Dr. Snyder said. “Education, encouragement, systems programming, such as including decision support within the electronic health record, and role-modeling from local champions will promote wider adoption of this lifesaving practice.”

Looking ahead, “more research, including prospective research, is needed to refine best practices around buprenorphine administration,” said Dr. Snyder. Questions to address include which patients are most at risk for precipitated withdrawal and whether there are alternatives to standard initiation dosing that are sufficiently unlikely to cause precipitated withdrawal. “Possibly effective alternatives include buprenorphine initiation by administration of long-acting injectable depot buprenorphine, which accumulates slowly, potentially avoiding precipitated withdrawal, as well as a slow intravenous buprenorphine infusion such as 9 mg given over 12 hours.”

The study received no outside funding. Dr. Snyder disclosed grants from the Substance Abuse and Mental Health Services Administration and the California Department of Health Care Services during the study. Dr. Strayer reported no relevant financial relationships.

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

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Telehealth doctor indicted on health care fraud, opioid distribution charges

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Mon, 03/13/2023 - 14:34

A Michigan physician has been indicted by a federal grand jury on charges of health care fraud and conspiracy to distribute controlled substances.

Sangita Patel, MD, 50, practiced at Advance Medical Home Physicians in Troy.

According to court documents, between July 2020 and June 2022 Patel was responsible for submitting Medicare claims for improper telehealth visits she didn’t conduct herself.

Dr. Patel, who accepted patients who paid in cash as well as those with Medicare and Medicaid coverage, billed approximately $3.4 million to Medicare between 2018 and 2022, according to court documents. An unusual number of these visits were billed using complex codes, an indication of health care fraud. The investigation also found that on many days, Dr. Patel billed for more than 24 hours of services. During this period, according to the document, 76% of Dr. Patel’s Medicare reimbursements were for telehealth.

Prosecutors say that Dr. Patel prescribed Schedule II controlled substances to more than 90% of the patients in these telehealth visits. She delegated her prescription authority to an unlicensed medical assistant. Through undercover visits and cell site search warrant data, the investigation found that Dr. Patel directed patients to contact, via cell phone, this assistant, who then entered electronic prescriptions into the electronic medical records system. Dr. Patel then signed the prescriptions and sent them to the pharmacies without ever interacting with the patients. Prosecutors also used text messages, obtained by search warrant, between Dr. Patel and her assistant and between the assistant and undercover informers to build their case.

Dr. Patel is also accused of referring patients to other providers, who in turn billed Medicare for claims associated with those patients. Advance Medical received $143,000 from these providers, potentially in violation of anti-kickback laws, according to bank records obtained by subpoena.

If convicted, Dr. Patel could be sentenced to up to 10 years in federal prison.

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

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A Michigan physician has been indicted by a federal grand jury on charges of health care fraud and conspiracy to distribute controlled substances.

Sangita Patel, MD, 50, practiced at Advance Medical Home Physicians in Troy.

According to court documents, between July 2020 and June 2022 Patel was responsible for submitting Medicare claims for improper telehealth visits she didn’t conduct herself.

Dr. Patel, who accepted patients who paid in cash as well as those with Medicare and Medicaid coverage, billed approximately $3.4 million to Medicare between 2018 and 2022, according to court documents. An unusual number of these visits were billed using complex codes, an indication of health care fraud. The investigation also found that on many days, Dr. Patel billed for more than 24 hours of services. During this period, according to the document, 76% of Dr. Patel’s Medicare reimbursements were for telehealth.

Prosecutors say that Dr. Patel prescribed Schedule II controlled substances to more than 90% of the patients in these telehealth visits. She delegated her prescription authority to an unlicensed medical assistant. Through undercover visits and cell site search warrant data, the investigation found that Dr. Patel directed patients to contact, via cell phone, this assistant, who then entered electronic prescriptions into the electronic medical records system. Dr. Patel then signed the prescriptions and sent them to the pharmacies without ever interacting with the patients. Prosecutors also used text messages, obtained by search warrant, between Dr. Patel and her assistant and between the assistant and undercover informers to build their case.

Dr. Patel is also accused of referring patients to other providers, who in turn billed Medicare for claims associated with those patients. Advance Medical received $143,000 from these providers, potentially in violation of anti-kickback laws, according to bank records obtained by subpoena.

If convicted, Dr. Patel could be sentenced to up to 10 years in federal prison.

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

A Michigan physician has been indicted by a federal grand jury on charges of health care fraud and conspiracy to distribute controlled substances.

Sangita Patel, MD, 50, practiced at Advance Medical Home Physicians in Troy.

According to court documents, between July 2020 and June 2022 Patel was responsible for submitting Medicare claims for improper telehealth visits she didn’t conduct herself.

Dr. Patel, who accepted patients who paid in cash as well as those with Medicare and Medicaid coverage, billed approximately $3.4 million to Medicare between 2018 and 2022, according to court documents. An unusual number of these visits were billed using complex codes, an indication of health care fraud. The investigation also found that on many days, Dr. Patel billed for more than 24 hours of services. During this period, according to the document, 76% of Dr. Patel’s Medicare reimbursements were for telehealth.

Prosecutors say that Dr. Patel prescribed Schedule II controlled substances to more than 90% of the patients in these telehealth visits. She delegated her prescription authority to an unlicensed medical assistant. Through undercover visits and cell site search warrant data, the investigation found that Dr. Patel directed patients to contact, via cell phone, this assistant, who then entered electronic prescriptions into the electronic medical records system. Dr. Patel then signed the prescriptions and sent them to the pharmacies without ever interacting with the patients. Prosecutors also used text messages, obtained by search warrant, between Dr. Patel and her assistant and between the assistant and undercover informers to build their case.

Dr. Patel is also accused of referring patients to other providers, who in turn billed Medicare for claims associated with those patients. Advance Medical received $143,000 from these providers, potentially in violation of anti-kickback laws, according to bank records obtained by subpoena.

If convicted, Dr. Patel could be sentenced to up to 10 years in federal prison.

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

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Migraine after concussion linked to worse outcomes

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Thu, 03/09/2023 - 18:24

Children who experience migraine headaches in the aftermath of a concussion are more likely to experience prolonged symptoms of the head injury than are those with other forms of headache or no headaches at all, researchers have found.

“Early assessment of headache – and whether it has migraine features – after concussion can be helpful in predicting which children are at risk for poor outcomes and identifying children who require targeted intervention,” said senior author Keith Owen Yeates, PhD, the Ronald and Irene Ward Chair in Pediatric Brain Injury Professor and head of the department of psychology at the University of Calgary (Alta.). “Posttraumatic headache, especially when it involves migraine features, is a strong predictor of persisting symptoms and poorer quality of life after childhood concussion.”

Approximately 840,000 children per year visit an emergency department in the United States after having a traumatic brain injury. As many as 90% of those visits are considered to involve a concussion, according to the investigators. Although most children recover quickly, approximately one-third continue to report symptoms a month after the event.

Posttraumatic headache occurs in up to 90% of children, most commonly with features of migraine.

The new study, published in JAMA Network Open, was a secondary analysis of the Advancing Concussion Assessment in Pediatrics (A-CAP) prospective cohort study. The study was conducted at five emergency departments in Canada from September 2016 to July 2019 and included children and adolescents aged 8-17 years who presented with acute concussion or an orthopedic injury.

Children were included in the concussion group if they had a history of blunt head trauma resulting in at least one of three criteria consistent with the World Health Organization definition of mild traumatic brain injury. The criteria include loss of consciousness for less than 30 minutes, a Glasgow Coma Scale score of 13 or 14, or at least one acute sign or symptom of concussion, as noted by emergency clinicians.

Patients were excluded from the concussion group if they had deteriorating neurologic status, underwent neurosurgical intervention, had posttraumatic amnesia that lasted more than 24 hours, or had a score higher than 4 on the Abbreviated Injury Scale (AIS). The orthopedic injury group included patients without symptoms of concussion and with blunt trauma associated with an AIS 13 score of 4 or less. Patients were excluded from both groups if they had an overnight hospitalization for traumatic brain injury, a concussion within the past 3 months, or a neurodevelopmental disorder.

The researchers analyzed data from 928 children of 967 enrolled in the study. The median age was 12.2 years, and 41.3% were female. The final study cohort included 239 children with orthopedic injuries but no headache, 160 with a concussion and no headache, 134 with a concussion and nonmigraine headaches, and 254 with a concussion and migraine headaches.

Children with posttraumatic migraines 10 days after a concussion had the most severe symptoms and worst quality of life 3 months following their head trauma, the researchers found. Children without headaches within 10 days after concussion had the best 3-month outcomes, comparable to those with orthopedic injuries alone.

The researchers said the strengths of their study included its large population and its inclusion of various causes of head trauma, not just sports-related concussions. Limitations included self-reports of headaches instead of a physician diagnosis and lack of control for clinical interventions that might have affected the outcomes.

Charles Tator, MD, PhD, director of the Canadian Concussion Centre at Toronto Western Hospital, said the findings were unsurprising.

“Headaches are the most common symptom after concussion,” Dr. Tator, who was not involved in the latest research, told this news organization. “In my practice and research with concussed kids 11 and up and with adults, those with preconcussion history of migraine are the most difficult to treat because their headaches don’t improve unless specific measures are taken.”

Dr. Tator, who also is a professor of neurosurgery at the University of Toronto, said clinicians who treat concussions must determine which type of headaches children are experiencing – and refer as early as possible for migraine prevention or treatment and medication, as warranted.

“Early recognition after concussion that migraine headaches are occurring will save kids a lot of suffering,” he said.

The study was supported by a Canadian Institute of Health Research Foundation Grant and by funds from the Alberta Children’s Hospital Foundation and the Alberta Children’s Hospital Research Institute. Dr. Tator has disclosed no relevant financial relationships.
 

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

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Children who experience migraine headaches in the aftermath of a concussion are more likely to experience prolonged symptoms of the head injury than are those with other forms of headache or no headaches at all, researchers have found.

“Early assessment of headache – and whether it has migraine features – after concussion can be helpful in predicting which children are at risk for poor outcomes and identifying children who require targeted intervention,” said senior author Keith Owen Yeates, PhD, the Ronald and Irene Ward Chair in Pediatric Brain Injury Professor and head of the department of psychology at the University of Calgary (Alta.). “Posttraumatic headache, especially when it involves migraine features, is a strong predictor of persisting symptoms and poorer quality of life after childhood concussion.”

Approximately 840,000 children per year visit an emergency department in the United States after having a traumatic brain injury. As many as 90% of those visits are considered to involve a concussion, according to the investigators. Although most children recover quickly, approximately one-third continue to report symptoms a month after the event.

Posttraumatic headache occurs in up to 90% of children, most commonly with features of migraine.

The new study, published in JAMA Network Open, was a secondary analysis of the Advancing Concussion Assessment in Pediatrics (A-CAP) prospective cohort study. The study was conducted at five emergency departments in Canada from September 2016 to July 2019 and included children and adolescents aged 8-17 years who presented with acute concussion or an orthopedic injury.

Children were included in the concussion group if they had a history of blunt head trauma resulting in at least one of three criteria consistent with the World Health Organization definition of mild traumatic brain injury. The criteria include loss of consciousness for less than 30 minutes, a Glasgow Coma Scale score of 13 or 14, or at least one acute sign or symptom of concussion, as noted by emergency clinicians.

Patients were excluded from the concussion group if they had deteriorating neurologic status, underwent neurosurgical intervention, had posttraumatic amnesia that lasted more than 24 hours, or had a score higher than 4 on the Abbreviated Injury Scale (AIS). The orthopedic injury group included patients without symptoms of concussion and with blunt trauma associated with an AIS 13 score of 4 or less. Patients were excluded from both groups if they had an overnight hospitalization for traumatic brain injury, a concussion within the past 3 months, or a neurodevelopmental disorder.

The researchers analyzed data from 928 children of 967 enrolled in the study. The median age was 12.2 years, and 41.3% were female. The final study cohort included 239 children with orthopedic injuries but no headache, 160 with a concussion and no headache, 134 with a concussion and nonmigraine headaches, and 254 with a concussion and migraine headaches.

Children with posttraumatic migraines 10 days after a concussion had the most severe symptoms and worst quality of life 3 months following their head trauma, the researchers found. Children without headaches within 10 days after concussion had the best 3-month outcomes, comparable to those with orthopedic injuries alone.

The researchers said the strengths of their study included its large population and its inclusion of various causes of head trauma, not just sports-related concussions. Limitations included self-reports of headaches instead of a physician diagnosis and lack of control for clinical interventions that might have affected the outcomes.

Charles Tator, MD, PhD, director of the Canadian Concussion Centre at Toronto Western Hospital, said the findings were unsurprising.

“Headaches are the most common symptom after concussion,” Dr. Tator, who was not involved in the latest research, told this news organization. “In my practice and research with concussed kids 11 and up and with adults, those with preconcussion history of migraine are the most difficult to treat because their headaches don’t improve unless specific measures are taken.”

Dr. Tator, who also is a professor of neurosurgery at the University of Toronto, said clinicians who treat concussions must determine which type of headaches children are experiencing – and refer as early as possible for migraine prevention or treatment and medication, as warranted.

“Early recognition after concussion that migraine headaches are occurring will save kids a lot of suffering,” he said.

The study was supported by a Canadian Institute of Health Research Foundation Grant and by funds from the Alberta Children’s Hospital Foundation and the Alberta Children’s Hospital Research Institute. Dr. Tator has disclosed no relevant financial relationships.
 

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

Children who experience migraine headaches in the aftermath of a concussion are more likely to experience prolonged symptoms of the head injury than are those with other forms of headache or no headaches at all, researchers have found.

“Early assessment of headache – and whether it has migraine features – after concussion can be helpful in predicting which children are at risk for poor outcomes and identifying children who require targeted intervention,” said senior author Keith Owen Yeates, PhD, the Ronald and Irene Ward Chair in Pediatric Brain Injury Professor and head of the department of psychology at the University of Calgary (Alta.). “Posttraumatic headache, especially when it involves migraine features, is a strong predictor of persisting symptoms and poorer quality of life after childhood concussion.”

Approximately 840,000 children per year visit an emergency department in the United States after having a traumatic brain injury. As many as 90% of those visits are considered to involve a concussion, according to the investigators. Although most children recover quickly, approximately one-third continue to report symptoms a month after the event.

Posttraumatic headache occurs in up to 90% of children, most commonly with features of migraine.

The new study, published in JAMA Network Open, was a secondary analysis of the Advancing Concussion Assessment in Pediatrics (A-CAP) prospective cohort study. The study was conducted at five emergency departments in Canada from September 2016 to July 2019 and included children and adolescents aged 8-17 years who presented with acute concussion or an orthopedic injury.

Children were included in the concussion group if they had a history of blunt head trauma resulting in at least one of three criteria consistent with the World Health Organization definition of mild traumatic brain injury. The criteria include loss of consciousness for less than 30 minutes, a Glasgow Coma Scale score of 13 or 14, or at least one acute sign or symptom of concussion, as noted by emergency clinicians.

Patients were excluded from the concussion group if they had deteriorating neurologic status, underwent neurosurgical intervention, had posttraumatic amnesia that lasted more than 24 hours, or had a score higher than 4 on the Abbreviated Injury Scale (AIS). The orthopedic injury group included patients without symptoms of concussion and with blunt trauma associated with an AIS 13 score of 4 or less. Patients were excluded from both groups if they had an overnight hospitalization for traumatic brain injury, a concussion within the past 3 months, or a neurodevelopmental disorder.

The researchers analyzed data from 928 children of 967 enrolled in the study. The median age was 12.2 years, and 41.3% were female. The final study cohort included 239 children with orthopedic injuries but no headache, 160 with a concussion and no headache, 134 with a concussion and nonmigraine headaches, and 254 with a concussion and migraine headaches.

Children with posttraumatic migraines 10 days after a concussion had the most severe symptoms and worst quality of life 3 months following their head trauma, the researchers found. Children without headaches within 10 days after concussion had the best 3-month outcomes, comparable to those with orthopedic injuries alone.

The researchers said the strengths of their study included its large population and its inclusion of various causes of head trauma, not just sports-related concussions. Limitations included self-reports of headaches instead of a physician diagnosis and lack of control for clinical interventions that might have affected the outcomes.

Charles Tator, MD, PhD, director of the Canadian Concussion Centre at Toronto Western Hospital, said the findings were unsurprising.

“Headaches are the most common symptom after concussion,” Dr. Tator, who was not involved in the latest research, told this news organization. “In my practice and research with concussed kids 11 and up and with adults, those with preconcussion history of migraine are the most difficult to treat because their headaches don’t improve unless specific measures are taken.”

Dr. Tator, who also is a professor of neurosurgery at the University of Toronto, said clinicians who treat concussions must determine which type of headaches children are experiencing – and refer as early as possible for migraine prevention or treatment and medication, as warranted.

“Early recognition after concussion that migraine headaches are occurring will save kids a lot of suffering,” he said.

The study was supported by a Canadian Institute of Health Research Foundation Grant and by funds from the Alberta Children’s Hospital Foundation and the Alberta Children’s Hospital Research Institute. Dr. Tator has disclosed no relevant financial relationships.
 

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

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Shaved costs, high risk, maximum profits: Regulators worry about Florida’s butt lift boom

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Mon, 03/20/2023 - 08:55

In hindsight, Nikki Ruston said, she should have recognized the red flags.

The office in Miami where she scheduled what’s known as a Brazilian butt lift had closed and transferred her records to a different facility, she said. The price she was quoted – and paid upfront – increased the day of the procedure, and she said she did not meet her surgeon until she was about to be placed under general anesthesia.

“I was ready to walk out,” said Ms. Ruston, 44, of Lake Alfred in Central Florida. “But I had paid everything.”

A few days after the July procedure, Ms. Ruston was hospitalized because of infection, blood loss, and nausea, her medical records show.

“I went cheap. That’s what I did,” Ms. Ruston recalled recently. “I looked for the lowest price, and I found him on Instagram.”

Daniel Chang/KHN
The business model of high-volume, lower-priced office surgery centers popularized in Miami is spreading to other places, researchers and plastic surgeons say.

People like Ms. Ruston are commonly lured to office-based surgery centers in South Florida through social media marketing that makes Brazilian butt lifts and other cosmetic surgery look deceptively painless, safe, and affordable, say researchers, patient advocates, and surgeon groups.

Unlike ambulatory surgery centers and hospitals, where a patient might stay overnight for observation after treatment, office-based surgery centers offer procedures that don’t typically require an inpatient stay and are regulated as an extension of a doctor’s private practice.

Daniel Chang/KHN
People seeking Brazilian butt lifts and other cosmetic procedures are commonly lured to office-based surgery centers in South Florida through social media marketing and the promise of discount prices.

But such surgical offices are often owned by corporations that can offer discount prices by contracting with surgeons who are incentivized to work on as many patients per day as possible, in as little time as possible, according to state regulators and physicians critical of the facilities.

Ms. Ruston said she now lives with constant pain, but for other patients a Brazilian butt lift cost them their lives. After a rash of deaths, and in the absence of national standards, Florida regulators were the first in the nation to enact rules in 2019 meant to make the procedures safer. More than 3 years later, data shows deaths still occur.

Daniel Chang/KHN
Some South Florida cosmetic surgery centers share office space with law firms and other businesses. At Avana Plastic Surgery, an office surgery center in Miami, patients use a separate entrance apart from the main lobby.

Patient advocates and some surgeons – including those who perform the procedure themselves – anticipate the problem will only get worse. Emergency restrictions imposed by the state’s medical board in June expired in September, and the corporate business model popularized in Miami is spreading to other cities.

“We’re seeing entities that have a strong footprint in low-cost, high-volume cosmetic surgery, based in South Florida, manifesting in other parts of the country,” said Bob Basu, MD, MPH, a vice president of the American Society of Plastic Surgeons and a practicing physician in Houston.

During a Brazilian butt lift, fat is taken via liposuction from other areas of the body – such as the torso, back, or thighs – and injected into the buttocks. More than 61,000 buttock augmentation procedures, both butt lifts and implants, were performed nationwide in 2021, a 37% increase from the previous year, according to data from the Aesthetic Society, a trade group of plastic surgeons.

As with all surgery, complications can occur. Miami-Dade County’s medical examiner has documented nearly three dozen cosmetic surgery patient deaths since 2009, of which 26 resulted from a Brazilian butt lift. In each case, the person died from a pulmonary fat embolism, when fat entered the bloodstream through veins in the gluteal muscles and stopped blood from flowing to the lungs.

No national reporting system or insurance code tracks outcomes and patient demographics for a Brazilian butt lift. About 3% of surgeons worldwide had a patient die as a result of the procedure, according to a 2017 report from an Aesthetic Surgery Education and Research Foundation task force.

Medical experts said the problem is driven, in part, by having medical professionals like physician assistants and nurse practitioners perform key parts of the butt lift instead of doctors. It’s also driven by a business model that is motivated by profit, not safety, and incentivizes surgeons to exceed the number of surgeries outlined in their contracts.

In May, after a fifth patient in as many months died of complications in Miami-Dade County, Kevin Cairns, MD, proposed the state’s emergency rule to limit the number of butt lifts a surgeon could perform each day.

“I was getting sick of reading about women dying and seeing cases come before the board,” said Dr. Cairns, a physician and former member of the Florida Board of Medicine.

Some doctors performed as many as seven, according to disciplinary cases against surgeons prosecuted by the Florida Department of Health. The emergency rule limited them to no more than three, and required the use of an ultrasound to help surgeons lower the risk of a pulmonary fat clot.

But a group of physicians who perform Brazilian butt lifts in South Florida clapped back and formed Surgeons for Safety. They argued the new requirements would make the situation worse. Qualified doctors would have to do fewer procedures, they said, thus driving patients to dangerous medical professionals who don’t follow rules.

The group has since donated more than $350,000 to the state’s Republican Party, Republican candidates, and Republican political action committees, according to campaign contribution data from the Florida Department of State.

Surgeons for Safety declined KHN’s repeated interview requests. Although the group’s president, Constantino Mendieta, MD, wrote in an August editorial that he agreed not all surgeons have followed the standard of care, he called the limits put on surgeons “arbitrary.” The rule sets “a historic precedent of controlling surgeons,” he said during a meeting with Florida’s medical board.

In January, Florida state Sen. Ileana Garcia, a Republican, filed a draft bill with the state legislature that proposes no limit on the number of Brazilian butt lifts a surgeon can perform in a day. Instead, it requires office surgery centers where the procedures are performed to staff one physician per patient and prohibits surgeons from working on more than one person at a time.

The bill would also allow surgeons to delegate some parts of the procedure to other clinicians under their direct supervision.

Florida’s legislature convenes on March 7.

Consumers considering cosmetic procedures are urged to be cautious. Like Ms. Ruston, many people base their expectations on before-and-after photos and marketing videos posted on social media platforms such as Facebook, Snapchat, and Instagram.

“That’s very dangerous,” said Dr. Basu, of the American Society of Plastic Surgeons. “They’re excited about a low price and they forget about doing their homework,” he said.

The average price of a buttocks augmentation in 2021 was $4,000, according to data from the Aesthetic Society. But that’s only for the physician’s fee and does not cover anesthesia, operating room fees, prescriptions, or other expenses. A “safe” Brazilian butt lift, performed in an accredited facility and with proper aftercare, costs between $12,000 and $18,000, according to a recent article on the American Society of Plastic Surgeons’ website.

Although Florida requires a physician’s license to perform liposuction on patients who are under general anesthesia, it’s common in the medical field for midlevel medical practitioners, such as physician assistants and nurse practitioners, to do the procedure in office settings, according to Mark Mofid, MD, who coauthored the 2017 Aesthetic Surgery Education and Research Foundation task force study.

By relying on staffers who don’t have the same specialty training and get paid less, office-based surgeons can complete more butt lifts per day and charge a lower price.

“They’re doing all of them simultaneously in three or four different rooms, and it’s being staffed by one surgeon,” said Dr. Mofid, a plastic surgeon in San Diego, who added that he does not perform more than one Brazilian butt lift in a day. “The surgeon isn’t doing the actual case. It’s assistants.”

Dr. Basu said patients should ask whether their doctor holds privileges to perform the same procedure at a hospital or ambulatory surgery center, which have stricter rules than office surgery centers in terms of who can perform butt lifts and how they should be done.

People in search of bargains are reminded that cosmetic surgery can have other serious risks beyond the deadly fat clots, such as infection and organ puncture, plus problems with the kidneys, heart, and lungs.

Ms. Ruston’s surgery was performed by a board-certified plastic surgeon she said she found on Instagram. She was originally quoted $4,995, which she said she paid in full before surgery. But when she arrived in Miami, she said, the clinic tacked on fees for liposuction and for postsurgical garments and devices.

“I ended up having to pay, like, $8,000,” Ms. Ruston said. A few days after Ms. Ruston returned home to Lake Alfred, she said, she started to feel dizzy and weak and called 911.

Paramedics took her to an emergency room, where doctors diagnosed her with anemia due to blood loss, and blood and abdominal infections, her medical records show.

“If I could go back in time,” she said, “I wouldn’t have had it done.”

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.

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In hindsight, Nikki Ruston said, she should have recognized the red flags.

The office in Miami where she scheduled what’s known as a Brazilian butt lift had closed and transferred her records to a different facility, she said. The price she was quoted – and paid upfront – increased the day of the procedure, and she said she did not meet her surgeon until she was about to be placed under general anesthesia.

“I was ready to walk out,” said Ms. Ruston, 44, of Lake Alfred in Central Florida. “But I had paid everything.”

A few days after the July procedure, Ms. Ruston was hospitalized because of infection, blood loss, and nausea, her medical records show.

“I went cheap. That’s what I did,” Ms. Ruston recalled recently. “I looked for the lowest price, and I found him on Instagram.”

Daniel Chang/KHN
The business model of high-volume, lower-priced office surgery centers popularized in Miami is spreading to other places, researchers and plastic surgeons say.

People like Ms. Ruston are commonly lured to office-based surgery centers in South Florida through social media marketing that makes Brazilian butt lifts and other cosmetic surgery look deceptively painless, safe, and affordable, say researchers, patient advocates, and surgeon groups.

Unlike ambulatory surgery centers and hospitals, where a patient might stay overnight for observation after treatment, office-based surgery centers offer procedures that don’t typically require an inpatient stay and are regulated as an extension of a doctor’s private practice.

Daniel Chang/KHN
People seeking Brazilian butt lifts and other cosmetic procedures are commonly lured to office-based surgery centers in South Florida through social media marketing and the promise of discount prices.

But such surgical offices are often owned by corporations that can offer discount prices by contracting with surgeons who are incentivized to work on as many patients per day as possible, in as little time as possible, according to state regulators and physicians critical of the facilities.

Ms. Ruston said she now lives with constant pain, but for other patients a Brazilian butt lift cost them their lives. After a rash of deaths, and in the absence of national standards, Florida regulators were the first in the nation to enact rules in 2019 meant to make the procedures safer. More than 3 years later, data shows deaths still occur.

Daniel Chang/KHN
Some South Florida cosmetic surgery centers share office space with law firms and other businesses. At Avana Plastic Surgery, an office surgery center in Miami, patients use a separate entrance apart from the main lobby.

Patient advocates and some surgeons – including those who perform the procedure themselves – anticipate the problem will only get worse. Emergency restrictions imposed by the state’s medical board in June expired in September, and the corporate business model popularized in Miami is spreading to other cities.

“We’re seeing entities that have a strong footprint in low-cost, high-volume cosmetic surgery, based in South Florida, manifesting in other parts of the country,” said Bob Basu, MD, MPH, a vice president of the American Society of Plastic Surgeons and a practicing physician in Houston.

During a Brazilian butt lift, fat is taken via liposuction from other areas of the body – such as the torso, back, or thighs – and injected into the buttocks. More than 61,000 buttock augmentation procedures, both butt lifts and implants, were performed nationwide in 2021, a 37% increase from the previous year, according to data from the Aesthetic Society, a trade group of plastic surgeons.

As with all surgery, complications can occur. Miami-Dade County’s medical examiner has documented nearly three dozen cosmetic surgery patient deaths since 2009, of which 26 resulted from a Brazilian butt lift. In each case, the person died from a pulmonary fat embolism, when fat entered the bloodstream through veins in the gluteal muscles and stopped blood from flowing to the lungs.

No national reporting system or insurance code tracks outcomes and patient demographics for a Brazilian butt lift. About 3% of surgeons worldwide had a patient die as a result of the procedure, according to a 2017 report from an Aesthetic Surgery Education and Research Foundation task force.

Medical experts said the problem is driven, in part, by having medical professionals like physician assistants and nurse practitioners perform key parts of the butt lift instead of doctors. It’s also driven by a business model that is motivated by profit, not safety, and incentivizes surgeons to exceed the number of surgeries outlined in their contracts.

In May, after a fifth patient in as many months died of complications in Miami-Dade County, Kevin Cairns, MD, proposed the state’s emergency rule to limit the number of butt lifts a surgeon could perform each day.

“I was getting sick of reading about women dying and seeing cases come before the board,” said Dr. Cairns, a physician and former member of the Florida Board of Medicine.

Some doctors performed as many as seven, according to disciplinary cases against surgeons prosecuted by the Florida Department of Health. The emergency rule limited them to no more than three, and required the use of an ultrasound to help surgeons lower the risk of a pulmonary fat clot.

But a group of physicians who perform Brazilian butt lifts in South Florida clapped back and formed Surgeons for Safety. They argued the new requirements would make the situation worse. Qualified doctors would have to do fewer procedures, they said, thus driving patients to dangerous medical professionals who don’t follow rules.

The group has since donated more than $350,000 to the state’s Republican Party, Republican candidates, and Republican political action committees, according to campaign contribution data from the Florida Department of State.

Surgeons for Safety declined KHN’s repeated interview requests. Although the group’s president, Constantino Mendieta, MD, wrote in an August editorial that he agreed not all surgeons have followed the standard of care, he called the limits put on surgeons “arbitrary.” The rule sets “a historic precedent of controlling surgeons,” he said during a meeting with Florida’s medical board.

In January, Florida state Sen. Ileana Garcia, a Republican, filed a draft bill with the state legislature that proposes no limit on the number of Brazilian butt lifts a surgeon can perform in a day. Instead, it requires office surgery centers where the procedures are performed to staff one physician per patient and prohibits surgeons from working on more than one person at a time.

The bill would also allow surgeons to delegate some parts of the procedure to other clinicians under their direct supervision.

Florida’s legislature convenes on March 7.

Consumers considering cosmetic procedures are urged to be cautious. Like Ms. Ruston, many people base their expectations on before-and-after photos and marketing videos posted on social media platforms such as Facebook, Snapchat, and Instagram.

“That’s very dangerous,” said Dr. Basu, of the American Society of Plastic Surgeons. “They’re excited about a low price and they forget about doing their homework,” he said.

The average price of a buttocks augmentation in 2021 was $4,000, according to data from the Aesthetic Society. But that’s only for the physician’s fee and does not cover anesthesia, operating room fees, prescriptions, or other expenses. A “safe” Brazilian butt lift, performed in an accredited facility and with proper aftercare, costs between $12,000 and $18,000, according to a recent article on the American Society of Plastic Surgeons’ website.

Although Florida requires a physician’s license to perform liposuction on patients who are under general anesthesia, it’s common in the medical field for midlevel medical practitioners, such as physician assistants and nurse practitioners, to do the procedure in office settings, according to Mark Mofid, MD, who coauthored the 2017 Aesthetic Surgery Education and Research Foundation task force study.

By relying on staffers who don’t have the same specialty training and get paid less, office-based surgeons can complete more butt lifts per day and charge a lower price.

“They’re doing all of them simultaneously in three or four different rooms, and it’s being staffed by one surgeon,” said Dr. Mofid, a plastic surgeon in San Diego, who added that he does not perform more than one Brazilian butt lift in a day. “The surgeon isn’t doing the actual case. It’s assistants.”

Dr. Basu said patients should ask whether their doctor holds privileges to perform the same procedure at a hospital or ambulatory surgery center, which have stricter rules than office surgery centers in terms of who can perform butt lifts and how they should be done.

People in search of bargains are reminded that cosmetic surgery can have other serious risks beyond the deadly fat clots, such as infection and organ puncture, plus problems with the kidneys, heart, and lungs.

Ms. Ruston’s surgery was performed by a board-certified plastic surgeon she said she found on Instagram. She was originally quoted $4,995, which she said she paid in full before surgery. But when she arrived in Miami, she said, the clinic tacked on fees for liposuction and for postsurgical garments and devices.

“I ended up having to pay, like, $8,000,” Ms. Ruston said. A few days after Ms. Ruston returned home to Lake Alfred, she said, she started to feel dizzy and weak and called 911.

Paramedics took her to an emergency room, where doctors diagnosed her with anemia due to blood loss, and blood and abdominal infections, her medical records show.

“If I could go back in time,” she said, “I wouldn’t have had it done.”

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.

In hindsight, Nikki Ruston said, she should have recognized the red flags.

The office in Miami where she scheduled what’s known as a Brazilian butt lift had closed and transferred her records to a different facility, she said. The price she was quoted – and paid upfront – increased the day of the procedure, and she said she did not meet her surgeon until she was about to be placed under general anesthesia.

“I was ready to walk out,” said Ms. Ruston, 44, of Lake Alfred in Central Florida. “But I had paid everything.”

A few days after the July procedure, Ms. Ruston was hospitalized because of infection, blood loss, and nausea, her medical records show.

“I went cheap. That’s what I did,” Ms. Ruston recalled recently. “I looked for the lowest price, and I found him on Instagram.”

Daniel Chang/KHN
The business model of high-volume, lower-priced office surgery centers popularized in Miami is spreading to other places, researchers and plastic surgeons say.

People like Ms. Ruston are commonly lured to office-based surgery centers in South Florida through social media marketing that makes Brazilian butt lifts and other cosmetic surgery look deceptively painless, safe, and affordable, say researchers, patient advocates, and surgeon groups.

Unlike ambulatory surgery centers and hospitals, where a patient might stay overnight for observation after treatment, office-based surgery centers offer procedures that don’t typically require an inpatient stay and are regulated as an extension of a doctor’s private practice.

Daniel Chang/KHN
People seeking Brazilian butt lifts and other cosmetic procedures are commonly lured to office-based surgery centers in South Florida through social media marketing and the promise of discount prices.

But such surgical offices are often owned by corporations that can offer discount prices by contracting with surgeons who are incentivized to work on as many patients per day as possible, in as little time as possible, according to state regulators and physicians critical of the facilities.

Ms. Ruston said she now lives with constant pain, but for other patients a Brazilian butt lift cost them their lives. After a rash of deaths, and in the absence of national standards, Florida regulators were the first in the nation to enact rules in 2019 meant to make the procedures safer. More than 3 years later, data shows deaths still occur.

Daniel Chang/KHN
Some South Florida cosmetic surgery centers share office space with law firms and other businesses. At Avana Plastic Surgery, an office surgery center in Miami, patients use a separate entrance apart from the main lobby.

Patient advocates and some surgeons – including those who perform the procedure themselves – anticipate the problem will only get worse. Emergency restrictions imposed by the state’s medical board in June expired in September, and the corporate business model popularized in Miami is spreading to other cities.

“We’re seeing entities that have a strong footprint in low-cost, high-volume cosmetic surgery, based in South Florida, manifesting in other parts of the country,” said Bob Basu, MD, MPH, a vice president of the American Society of Plastic Surgeons and a practicing physician in Houston.

During a Brazilian butt lift, fat is taken via liposuction from other areas of the body – such as the torso, back, or thighs – and injected into the buttocks. More than 61,000 buttock augmentation procedures, both butt lifts and implants, were performed nationwide in 2021, a 37% increase from the previous year, according to data from the Aesthetic Society, a trade group of plastic surgeons.

As with all surgery, complications can occur. Miami-Dade County’s medical examiner has documented nearly three dozen cosmetic surgery patient deaths since 2009, of which 26 resulted from a Brazilian butt lift. In each case, the person died from a pulmonary fat embolism, when fat entered the bloodstream through veins in the gluteal muscles and stopped blood from flowing to the lungs.

No national reporting system or insurance code tracks outcomes and patient demographics for a Brazilian butt lift. About 3% of surgeons worldwide had a patient die as a result of the procedure, according to a 2017 report from an Aesthetic Surgery Education and Research Foundation task force.

Medical experts said the problem is driven, in part, by having medical professionals like physician assistants and nurse practitioners perform key parts of the butt lift instead of doctors. It’s also driven by a business model that is motivated by profit, not safety, and incentivizes surgeons to exceed the number of surgeries outlined in their contracts.

In May, after a fifth patient in as many months died of complications in Miami-Dade County, Kevin Cairns, MD, proposed the state’s emergency rule to limit the number of butt lifts a surgeon could perform each day.

“I was getting sick of reading about women dying and seeing cases come before the board,” said Dr. Cairns, a physician and former member of the Florida Board of Medicine.

Some doctors performed as many as seven, according to disciplinary cases against surgeons prosecuted by the Florida Department of Health. The emergency rule limited them to no more than three, and required the use of an ultrasound to help surgeons lower the risk of a pulmonary fat clot.

But a group of physicians who perform Brazilian butt lifts in South Florida clapped back and formed Surgeons for Safety. They argued the new requirements would make the situation worse. Qualified doctors would have to do fewer procedures, they said, thus driving patients to dangerous medical professionals who don’t follow rules.

The group has since donated more than $350,000 to the state’s Republican Party, Republican candidates, and Republican political action committees, according to campaign contribution data from the Florida Department of State.

Surgeons for Safety declined KHN’s repeated interview requests. Although the group’s president, Constantino Mendieta, MD, wrote in an August editorial that he agreed not all surgeons have followed the standard of care, he called the limits put on surgeons “arbitrary.” The rule sets “a historic precedent of controlling surgeons,” he said during a meeting with Florida’s medical board.

In January, Florida state Sen. Ileana Garcia, a Republican, filed a draft bill with the state legislature that proposes no limit on the number of Brazilian butt lifts a surgeon can perform in a day. Instead, it requires office surgery centers where the procedures are performed to staff one physician per patient and prohibits surgeons from working on more than one person at a time.

The bill would also allow surgeons to delegate some parts of the procedure to other clinicians under their direct supervision.

Florida’s legislature convenes on March 7.

Consumers considering cosmetic procedures are urged to be cautious. Like Ms. Ruston, many people base their expectations on before-and-after photos and marketing videos posted on social media platforms such as Facebook, Snapchat, and Instagram.

“That’s very dangerous,” said Dr. Basu, of the American Society of Plastic Surgeons. “They’re excited about a low price and they forget about doing their homework,” he said.

The average price of a buttocks augmentation in 2021 was $4,000, according to data from the Aesthetic Society. But that’s only for the physician’s fee and does not cover anesthesia, operating room fees, prescriptions, or other expenses. A “safe” Brazilian butt lift, performed in an accredited facility and with proper aftercare, costs between $12,000 and $18,000, according to a recent article on the American Society of Plastic Surgeons’ website.

Although Florida requires a physician’s license to perform liposuction on patients who are under general anesthesia, it’s common in the medical field for midlevel medical practitioners, such as physician assistants and nurse practitioners, to do the procedure in office settings, according to Mark Mofid, MD, who coauthored the 2017 Aesthetic Surgery Education and Research Foundation task force study.

By relying on staffers who don’t have the same specialty training and get paid less, office-based surgeons can complete more butt lifts per day and charge a lower price.

“They’re doing all of them simultaneously in three or four different rooms, and it’s being staffed by one surgeon,” said Dr. Mofid, a plastic surgeon in San Diego, who added that he does not perform more than one Brazilian butt lift in a day. “The surgeon isn’t doing the actual case. It’s assistants.”

Dr. Basu said patients should ask whether their doctor holds privileges to perform the same procedure at a hospital or ambulatory surgery center, which have stricter rules than office surgery centers in terms of who can perform butt lifts and how they should be done.

People in search of bargains are reminded that cosmetic surgery can have other serious risks beyond the deadly fat clots, such as infection and organ puncture, plus problems with the kidneys, heart, and lungs.

Ms. Ruston’s surgery was performed by a board-certified plastic surgeon she said she found on Instagram. She was originally quoted $4,995, which she said she paid in full before surgery. But when she arrived in Miami, she said, the clinic tacked on fees for liposuction and for postsurgical garments and devices.

“I ended up having to pay, like, $8,000,” Ms. Ruston said. A few days after Ms. Ruston returned home to Lake Alfred, she said, she started to feel dizzy and weak and called 911.

Paramedics took her to an emergency room, where doctors diagnosed her with anemia due to blood loss, and blood and abdominal infections, her medical records show.

“If I could go back in time,” she said, “I wouldn’t have had it done.”

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.

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Which nonopioid meds are best for easing acute low back pain?

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Wed, 03/08/2023 - 14:36

Muscle relaxants and NSAIDs effectively improved symptoms of acute low back pain after 1 week of treatment, based on data from more than 3,000 individuals.

Acute low back pain (LBP) remains a common cause of disability worldwide, with a high socioeconomic burden, write Alice Baroncini, MD, of RWTH University Hospital, Aachen, Germany, and colleagues.

In an analysis published in the Journal of Orthopaedic Research, a team of investigators from Germany examined which nonopioid drugs are best for treating LBP.

The researchers identified 18 studies totaling 3,478 patients with acute low back pain of less than 12 weeks’ duration. They selected studies that only investigated the lumbar spine, and studies involving opioids were excluded. The mean age of the patients across all the studies was 42.5 years, and 54% were women. The mean duration of symptoms before treatment was 15.1 days.

Overall, muscle relaxants and NSAIDs demonstrated effectiveness in reducing pain and disability for acute LBP patients after about 1 week of use.

In addition, studies of a combination of NSAIDs and paracetamol (also known as acetaminophen) showed a greater improvement than NSAIDs alone, but paracetamol/acetaminophen alone had no significant impact on LBP.

Most patients with acute LBP experience spontaneous recovery and reduction of symptoms, thus the real impact of most medications is uncertain, the researchers write in their discussion. The lack of a placebo effect in the selected studies reinforces the hypothesis that nonopioid medications improve LBP symptoms, they say.

However, “while this work only focuses on the pharmacological management of acute LBP, it is fundamental to highlight that the use of drugs should always be a second-line strategy once other nonpharmacological, noninvasive therapies have proved to be insufficient,” the researchers write.

The study findings were limited by several factors, including the inability to distinguish among different NSAID classes, the inability to conduct a subanalysis of the best drug or treatment protocol for a given drug class, and the short follow-up period for the included studies, the researchers note.

More research is needed to address the effects of different drugs on LBP recurrence, they add.

However, the results support the current opinion that NSAIDs can be effectively used for LBP, strengthened by the large number of studies and relatively low risk of bias, the researchers conclude.

The current study addresses a common cause of morbidity among patients and highlights alternatives to opioid analgesics for its management, Suman Pal, MBBS, a specialist in hospital medicine at the University of New Mexico, Albuquerque, said in an interview.

Dr. Pal said he was not surprised by the results. “The findings of the study mirror prior studies,” he said. “However, the lack of benefit of paracetamol alone needs to be highlighted as important to clinical practice.”

A key message for clinicians is the role of NSAIDs in LBP, Dr. Pal said. “NSAIDs, either alone or in combination with paracetamol or myorelaxants, can be effective therapy for select patients with acute LBP.” However, “further research is needed to better identify which patients would derive most benefit from this approach,” he said.

Other research needs include more evidence to better understand the appropriate duration of therapy, given the potential for adverse effects with chronic NSAID use, Dr. Pal said.

The study received no outside funding. The researchers and Dr. Pal have disclosed no relevant financial relationships.

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

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Muscle relaxants and NSAIDs effectively improved symptoms of acute low back pain after 1 week of treatment, based on data from more than 3,000 individuals.

Acute low back pain (LBP) remains a common cause of disability worldwide, with a high socioeconomic burden, write Alice Baroncini, MD, of RWTH University Hospital, Aachen, Germany, and colleagues.

In an analysis published in the Journal of Orthopaedic Research, a team of investigators from Germany examined which nonopioid drugs are best for treating LBP.

The researchers identified 18 studies totaling 3,478 patients with acute low back pain of less than 12 weeks’ duration. They selected studies that only investigated the lumbar spine, and studies involving opioids were excluded. The mean age of the patients across all the studies was 42.5 years, and 54% were women. The mean duration of symptoms before treatment was 15.1 days.

Overall, muscle relaxants and NSAIDs demonstrated effectiveness in reducing pain and disability for acute LBP patients after about 1 week of use.

In addition, studies of a combination of NSAIDs and paracetamol (also known as acetaminophen) showed a greater improvement than NSAIDs alone, but paracetamol/acetaminophen alone had no significant impact on LBP.

Most patients with acute LBP experience spontaneous recovery and reduction of symptoms, thus the real impact of most medications is uncertain, the researchers write in their discussion. The lack of a placebo effect in the selected studies reinforces the hypothesis that nonopioid medications improve LBP symptoms, they say.

However, “while this work only focuses on the pharmacological management of acute LBP, it is fundamental to highlight that the use of drugs should always be a second-line strategy once other nonpharmacological, noninvasive therapies have proved to be insufficient,” the researchers write.

The study findings were limited by several factors, including the inability to distinguish among different NSAID classes, the inability to conduct a subanalysis of the best drug or treatment protocol for a given drug class, and the short follow-up period for the included studies, the researchers note.

More research is needed to address the effects of different drugs on LBP recurrence, they add.

However, the results support the current opinion that NSAIDs can be effectively used for LBP, strengthened by the large number of studies and relatively low risk of bias, the researchers conclude.

The current study addresses a common cause of morbidity among patients and highlights alternatives to opioid analgesics for its management, Suman Pal, MBBS, a specialist in hospital medicine at the University of New Mexico, Albuquerque, said in an interview.

Dr. Pal said he was not surprised by the results. “The findings of the study mirror prior studies,” he said. “However, the lack of benefit of paracetamol alone needs to be highlighted as important to clinical practice.”

A key message for clinicians is the role of NSAIDs in LBP, Dr. Pal said. “NSAIDs, either alone or in combination with paracetamol or myorelaxants, can be effective therapy for select patients with acute LBP.” However, “further research is needed to better identify which patients would derive most benefit from this approach,” he said.

Other research needs include more evidence to better understand the appropriate duration of therapy, given the potential for adverse effects with chronic NSAID use, Dr. Pal said.

The study received no outside funding. The researchers and Dr. Pal have disclosed no relevant financial relationships.

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

Muscle relaxants and NSAIDs effectively improved symptoms of acute low back pain after 1 week of treatment, based on data from more than 3,000 individuals.

Acute low back pain (LBP) remains a common cause of disability worldwide, with a high socioeconomic burden, write Alice Baroncini, MD, of RWTH University Hospital, Aachen, Germany, and colleagues.

In an analysis published in the Journal of Orthopaedic Research, a team of investigators from Germany examined which nonopioid drugs are best for treating LBP.

The researchers identified 18 studies totaling 3,478 patients with acute low back pain of less than 12 weeks’ duration. They selected studies that only investigated the lumbar spine, and studies involving opioids were excluded. The mean age of the patients across all the studies was 42.5 years, and 54% were women. The mean duration of symptoms before treatment was 15.1 days.

Overall, muscle relaxants and NSAIDs demonstrated effectiveness in reducing pain and disability for acute LBP patients after about 1 week of use.

In addition, studies of a combination of NSAIDs and paracetamol (also known as acetaminophen) showed a greater improvement than NSAIDs alone, but paracetamol/acetaminophen alone had no significant impact on LBP.

Most patients with acute LBP experience spontaneous recovery and reduction of symptoms, thus the real impact of most medications is uncertain, the researchers write in their discussion. The lack of a placebo effect in the selected studies reinforces the hypothesis that nonopioid medications improve LBP symptoms, they say.

However, “while this work only focuses on the pharmacological management of acute LBP, it is fundamental to highlight that the use of drugs should always be a second-line strategy once other nonpharmacological, noninvasive therapies have proved to be insufficient,” the researchers write.

The study findings were limited by several factors, including the inability to distinguish among different NSAID classes, the inability to conduct a subanalysis of the best drug or treatment protocol for a given drug class, and the short follow-up period for the included studies, the researchers note.

More research is needed to address the effects of different drugs on LBP recurrence, they add.

However, the results support the current opinion that NSAIDs can be effectively used for LBP, strengthened by the large number of studies and relatively low risk of bias, the researchers conclude.

The current study addresses a common cause of morbidity among patients and highlights alternatives to opioid analgesics for its management, Suman Pal, MBBS, a specialist in hospital medicine at the University of New Mexico, Albuquerque, said in an interview.

Dr. Pal said he was not surprised by the results. “The findings of the study mirror prior studies,” he said. “However, the lack of benefit of paracetamol alone needs to be highlighted as important to clinical practice.”

A key message for clinicians is the role of NSAIDs in LBP, Dr. Pal said. “NSAIDs, either alone or in combination with paracetamol or myorelaxants, can be effective therapy for select patients with acute LBP.” However, “further research is needed to better identify which patients would derive most benefit from this approach,” he said.

Other research needs include more evidence to better understand the appropriate duration of therapy, given the potential for adverse effects with chronic NSAID use, Dr. Pal said.

The study received no outside funding. The researchers and Dr. Pal have disclosed no relevant financial relationships.

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

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Swallow this: Tiny tech tracks your gut in real time

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Thu, 03/02/2023 - 12:50

From heartburn to hemorrhoids and everything in between, gastrointestinal troubles affect 60 million to 70 million Americans. Part of what makes them so frustrating – besides the frequent flights to the bathroom – are the invasive and uncomfortable tests one must endure for diagnosis, such as endoscopy (feeding a flexible tube into a person’s digestive tract) or x-rays that can involve higher radiation exposure.

But a revolutionary new option promising greater comfort and convenience could become available within the next few years.

A group of researchers has developed a small pill-like device that, once swallowed, can provide precise real-time data as it moves through your system. The technology is described in Nature Electronics, along with the results of in vitro and animal testing of how well it works.

“You can think of this like a GPS that you can see on your phone as your Lyft or Uber driver is moving around,” says study author Azita Emami, PhD, a professor of electrical engineering and medical engineering at the California Institute of Technology, Pasadena. “You can see the driver coming through the streets, and you can track it in real time, but imagine you can do that with much higher precision for a much smaller device inside the body.”

It’s not the first option for GI testing that can be swallowed. A “capsule endoscopy” camera can take pictures of the digestive tract. And a “wireless motility capsule” uses sensors to measure pH, temperature, and pressure. But these technologies may not work for the entire time it takes to pass through the gut, usually about 1-3 days. And while they gather information, you can’t track their location in the GI tract in real time. Your doctor can learn a lot from this level of detail.

“If a patient has motility problems in their GI tract, it can actually tell the [doctor] where the motility problem is happening, where the slowdown is happening, which is much more informative,” says Dr. Emami. Such slowdowns are common in notoriously frustrating GI issues like irritable bowel syndrome, or IBS, and inflammatory bowel disease, or IBD.

To develop this technology, the research team drew inspiration from magnetic resonance imaging, or MRI. Magnetic fields transmit data from the Bluetooth-enabled device to a smartphone. An external component, a magnetic field generator that looks like a flat mat, powers the device and is small enough to be carried in a backpack – or placed under a bed, attached to a jacket, or mounted to a toilet seat. The part that can be swallowed has tiny chips embedded in a capsulelike package.

Before this technology can go to market, more testing is needed, including clinical trials in humans, says Dr. Emami. That will likely take a few years.

The team also aims to make the device even smaller (it now measures about 1 cm wide and 2 cm long) and less expensive, and they want it to do more things, such as sending medicines to the GI tract. Those innovations could take a few more years.

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

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From heartburn to hemorrhoids and everything in between, gastrointestinal troubles affect 60 million to 70 million Americans. Part of what makes them so frustrating – besides the frequent flights to the bathroom – are the invasive and uncomfortable tests one must endure for diagnosis, such as endoscopy (feeding a flexible tube into a person’s digestive tract) or x-rays that can involve higher radiation exposure.

But a revolutionary new option promising greater comfort and convenience could become available within the next few years.

A group of researchers has developed a small pill-like device that, once swallowed, can provide precise real-time data as it moves through your system. The technology is described in Nature Electronics, along with the results of in vitro and animal testing of how well it works.

“You can think of this like a GPS that you can see on your phone as your Lyft or Uber driver is moving around,” says study author Azita Emami, PhD, a professor of electrical engineering and medical engineering at the California Institute of Technology, Pasadena. “You can see the driver coming through the streets, and you can track it in real time, but imagine you can do that with much higher precision for a much smaller device inside the body.”

It’s not the first option for GI testing that can be swallowed. A “capsule endoscopy” camera can take pictures of the digestive tract. And a “wireless motility capsule” uses sensors to measure pH, temperature, and pressure. But these technologies may not work for the entire time it takes to pass through the gut, usually about 1-3 days. And while they gather information, you can’t track their location in the GI tract in real time. Your doctor can learn a lot from this level of detail.

“If a patient has motility problems in their GI tract, it can actually tell the [doctor] where the motility problem is happening, where the slowdown is happening, which is much more informative,” says Dr. Emami. Such slowdowns are common in notoriously frustrating GI issues like irritable bowel syndrome, or IBS, and inflammatory bowel disease, or IBD.

To develop this technology, the research team drew inspiration from magnetic resonance imaging, or MRI. Magnetic fields transmit data from the Bluetooth-enabled device to a smartphone. An external component, a magnetic field generator that looks like a flat mat, powers the device and is small enough to be carried in a backpack – or placed under a bed, attached to a jacket, or mounted to a toilet seat. The part that can be swallowed has tiny chips embedded in a capsulelike package.

Before this technology can go to market, more testing is needed, including clinical trials in humans, says Dr. Emami. That will likely take a few years.

The team also aims to make the device even smaller (it now measures about 1 cm wide and 2 cm long) and less expensive, and they want it to do more things, such as sending medicines to the GI tract. Those innovations could take a few more years.

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

From heartburn to hemorrhoids and everything in between, gastrointestinal troubles affect 60 million to 70 million Americans. Part of what makes them so frustrating – besides the frequent flights to the bathroom – are the invasive and uncomfortable tests one must endure for diagnosis, such as endoscopy (feeding a flexible tube into a person’s digestive tract) or x-rays that can involve higher radiation exposure.

But a revolutionary new option promising greater comfort and convenience could become available within the next few years.

A group of researchers has developed a small pill-like device that, once swallowed, can provide precise real-time data as it moves through your system. The technology is described in Nature Electronics, along with the results of in vitro and animal testing of how well it works.

“You can think of this like a GPS that you can see on your phone as your Lyft or Uber driver is moving around,” says study author Azita Emami, PhD, a professor of electrical engineering and medical engineering at the California Institute of Technology, Pasadena. “You can see the driver coming through the streets, and you can track it in real time, but imagine you can do that with much higher precision for a much smaller device inside the body.”

It’s not the first option for GI testing that can be swallowed. A “capsule endoscopy” camera can take pictures of the digestive tract. And a “wireless motility capsule” uses sensors to measure pH, temperature, and pressure. But these technologies may not work for the entire time it takes to pass through the gut, usually about 1-3 days. And while they gather information, you can’t track their location in the GI tract in real time. Your doctor can learn a lot from this level of detail.

“If a patient has motility problems in their GI tract, it can actually tell the [doctor] where the motility problem is happening, where the slowdown is happening, which is much more informative,” says Dr. Emami. Such slowdowns are common in notoriously frustrating GI issues like irritable bowel syndrome, or IBS, and inflammatory bowel disease, or IBD.

To develop this technology, the research team drew inspiration from magnetic resonance imaging, or MRI. Magnetic fields transmit data from the Bluetooth-enabled device to a smartphone. An external component, a magnetic field generator that looks like a flat mat, powers the device and is small enough to be carried in a backpack – or placed under a bed, attached to a jacket, or mounted to a toilet seat. The part that can be swallowed has tiny chips embedded in a capsulelike package.

Before this technology can go to market, more testing is needed, including clinical trials in humans, says Dr. Emami. That will likely take a few years.

The team also aims to make the device even smaller (it now measures about 1 cm wide and 2 cm long) and less expensive, and they want it to do more things, such as sending medicines to the GI tract. Those innovations could take a few more years.

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

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U.S. vs. French guidelines for osteoporosis treatment

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Fri, 03/03/2023 - 14:03

The American College of Physicians has just updated its guidelines for osteoporosis treatment. Bernard Cortet, MD, PhD, chairperson of the Osteoporosis Research and Information Group and head of the rheumatology department at Lille (France) University Hospital, has agreed to compare the new U.S. guidelines to the 2018 French recommendations written under the aegis of the French Society for Rheumatology and GRIO. Dr. Cortet participated in drafting the French recommendations.

Question: The ACP “strongly” recommends initial pharmacologic treatment with bisphosphonate antiresorptive drugs (alendronate, ibandronate, risedronate, zoledronate) in postmenopausal females diagnosed with primary osteoporosis. Isn’t this what the SFR–GRIO have been recommending for many years?

Answer: The ACP reinforces its stance by arguing that in postmenopausal females with primary osteoporosis, bisphosphonates have the most favorable balance between benefits, harms, patient values and preferences, and cost among the drug classes that were evaluated. In addition to net clinical benefits, bisphosphonates are much cheaper than other pharmacologic treatments and are available in generic oral and injectable formulations.

Our French recommendations specify the choice of drug based on the type of fracture in women and on their bone mineral density (BMD). However, bisphosphonates are definitely given pride of place. When treatment for osteoporosis needs to be started, most of the time, a bisphosphonate is the treatment of choice.

Nevertheless, as also highlighted by the ACP, a more “aggressive” approach must be considered for more severe cases.

In the case of a severe fracture, the French recommendations indicate that all treatments can be prescribed. However, zoledronic acid should be favored as first-line treatment for a hip fracture. In other cases – with or without a nonsevere fracture – the therapeutic indication depends on the BMD values, and in difficult cases, on tools such as FRAX [the Fracture Risk Assessment Tool].

Our guidance strongly recommends opting for an injection in other contexts, such as significant decrease in bone density, presence of comorbidities, poor treatment compliance, brain function disorders, and polymedication.

Q. But it’s not really as simple as prescribing a bisphosphonate, is it?

A. You’re right, many people find the idea of taking bisphosphonates worrying because of associated jaw problems – osteonecrosis of the jaw – or atypical femoral fractures, based on what they’ve read on the Internet, where these serious adverse events are on display front and center with no mention of how often they actually happen and, often, failing to mention how effective bisphosphonates truly are.

These complications are real, but fortunately rare, especially during the first 5 years of treatment. To put this into context, for bisphosphonates, there’s one case of osteonecrosis of the jaw for every 10,000. And for denosumab, there are five cases for every 10,000. For atypical fractures, there’s one case for every 30,000 to 50,000.

Q. The U.S. guidelines also recommend that clinicians use a RANK ligand inhibitor – denosumab, also an antiresorptive drug – as second-line medical treatment. This is to reduce the risk of fractures in postmenopausal women diagnosed with primary osteoporosis and presenting with contraindications or side effects of bisphosphonates. Do you support the use of denosumab as second-line treatment?

A. French legislation classifies it as a second-line treatment, after bisphosphonates. However, there are arguments in favor of prescribing it as first-line treatment in some contexts. If denosumab is to be prescribed – via a twice-yearly subcutaneous injection – full compliance must be observed. If a patient is to stop taking denosumab, an opinion from a medical professional is required before treatment can be discontinued, and then treatment with bisphosphonates must be prescribed.

Q. The ACP recommends that clinicians use either a sclerostin inhibitor – romosozumab – or recombinant human parathyroid hormone – teriparatide – two anabolic agents, followed by a bisphosphonate, with the aim of reducing the risk of fractures. This is only used in women with primary osteoporosis who are at a very high risk of fracture. As romosozumab is not available in France, it’s not really worth discussing its use. Does this strategy seem advisable to you, though?

A. The main issue is what is understood by “women at a very high risk of fracture.” There’s no consensus on the definition of what constitutes a woman at a very high risk of fracture, but we can assume that it involves the combination of low BMD and at least one severe fracture.

The role of anabolic bone treatment, as [the ACP] has defined it, seems logical to me, because in cases of severe osteoporosis with fracture, the risk of recurrence is very high in the next 2-3 years. In a study comparing risedronate and teriparatide in cases of severe osteoporosis, teriparatide was more effective in reducing the recurrence of vertebral fractures.

The favorable opinion of the French National Authority for Health in relation to medical coverage for romosozumab in the treatment of severe postmenopausal osteoporosis in women under the age of 75 years with a history of severe fractures, a T-score less than –2.5, and no previous history of coronary artery disease dates to 2021. This is because medical coverage for this specific group was not listed in the marketing authorization (MA) description for this drug.

But the review by the Economic Committee for Health Products failed to reach a consensus regarding the price. Today, in theory, romosozumab can be dispensed in France by hospital pharmacies, because it is approved for use in public hospitals. Romosozumab is a very interesting drug for relatively young women, especially those with multiple vertebral fractures. This injectable treatment is more effective than teriparatide in increasing BMD values and more effective than alendronate in preventing the recurrence of fractures.

Regarding medical coverage, as it stands, in cases where patients have a T-score less than or equal to –3, the 2018 SFR–GRIO recommends starting treatment even if the patient has no fractures. In cases with severe fractures combined with very low BMD (T-score ≤ –3), injectable treatments may be used to reach a bone density target (T-score > –2.5 to –2 for the hip) at the end of the treatment plan. [These treatments include] zoledronic acid, denosumab (in case of bisphosphonate failure or intolerance), or a treatment plan with teriparatide (covered by medical insurance if the patient has at least two vertebral fractures) followed by an antiresorptive drug (bisphosphonate or denosumab).

Romosozumab is a humanized monoclonal antibody (IgG2) that binds to sclerostin and acts as an inhibitor. This increases bone formation because of the activation of [bone lining cells], the production of bone matrix by osteoblasts, and the recruitment of osteochondroprogenitor cells. Moreover, romosozumab causes changes in the expression of osteoclast mediators, which decreases bone resorption. Together, these two effects that increase bone formation and decrease bone resorption lead to the rapid increase of trabecular and cortical bone mass, as well as improvements in bone structure and strength.

Women treated with a bone anabolic agent must take an antiresorptive agent at the end of their treatment so that the benefits from the treatment remain in the long term. The French and U.S. guidelines line up on this point.

In patients with two prevalent vertebral fractures, the U.S. guidelines state that teriparatide can be prescribed as first-line treatment at diagnosis in the absence of any contraindications. We agree on this point as well.

Moreover, in women under the age of 70 years with osteoporosis requiring treatment, French experts recommend prescribing raloxifene, a selective estrogen-receptor modulator. This is if the risk of nonvertebral fracture is low, as defined by the absence of the following criteria: low hip T-score, risk of falling, and history of nonvertebral fracture. Opportunities for its use are limited, and it doesn’t even figure among the U.S. recommendations.

Q. The ACP recommends that clinicians adopt an individualized approach regarding whether to start medical treatment with a bisphosphonate in women over age 65 years with low bone mass (osteopenia) to reduce the risk of fractures. If treatment is started, they›re of the opinion that a bisphosphonate must be used. What are the recommendations in France?

A. It should be noted that this recommendation by the ACP is conditional because of the low-certainty evidence.

Here’s a brief reminder of important things to note: a T-score between –2.5 and –1 indicates osteopenia; a T-score less than or equal to –2.5 indicates osteoporosis; a T-score less than or equal to –2.5 with one or several fractures indicates severe osteoporosis. The French recommendations state that treatment is not justified if a patient’s T-score is higher than –2 and there’s no presence of fractures, even with risk factors (and/or multiple falls). For T-scores less than or equal to –2 and higher than –3, the decision to prescribe depends on the specialist.

Q. The ACP recommends that clinicians use bisphosphonates for the initial medical treatment to reduce the risk of fractures in men diagnosed with primary osteoporosis.

A. The ACP recommends that clinicians use a RANK ligand inhibitor – denosumab – as second-line medical treatment to reduce the risk of fractures in men diagnosed with primary osteoporosis who present with contraindications or who are experiencing side effects of bisphosphonates. This treatment is not covered by health insurance for men in France.

Between 20% and 25% of clinical osteoporotic fractures occur in men. After age 50 years, men are roughly 20% more likely to experience an osteoporotic fracture in their lifetime. The French recommendations regarding the management and treatment of osteoporosis in men were published in 2021.

In the case of severe fractures (vertebrae, pelvis, upper end of the femur, distal femur, proximal humerus) attributable to bone fragility, osteoporosis treatment is recommended if one of the T-scores is less than or equal to –1.

In the case of nonsevere fractures (particularly wrist and ankle) attributable to bone fragility, osteoporosis treatment is recommended if one of the T-scores is less than or equal to –2. If there are no fractures, osteoporosis treatment is recommended in men at risk of bone fragility or of falling and if one of the T-scores is less than or equal to –3. In patients who had a fracture of the upper end of the femur attributable to bone fragility, zoledronic acid is recommended as first-line treatment.

For men with a severe nonvertebral fracture, single vertebral fracture, or nonsevere fracture, two treatments are indicated and covered by health insurance in France: zoledronic acid and risedronate. In men with at least two vertebral fractures, the following treatments are indicated and covered by health insurance in France: teriparatide and risedronate. In this case, teriparatide is prescribed for a period of 18 months. It must be followed by a prescription of oral or intravenous bisphosphonates.

Q. What is your take on the HAS update to the proper use of osteoporosis medication that’s just been published?

A. Like in the 2018 SFR–GRIO guidelines, no update has been made to the section on postmenopausal osteoporosis, except for the HAS introduction to the proper use of romosozumab, even though it’s not covered by health insurance in France.

In accordance with the MA, it doesn’t make sense to include this drug on the list of treatment options available for women with and without fractures, as it’s not included in the HAS-selected list of drugs covered by health insurance in France.

But I’m glad that the HAS has adopted the GRIO and SFR recommendations regarding corticosteroid-induced osteoporosis. Preventive treatment for corticosteroid-induced osteoporosis must be considered as soon as the daily dose of corticosteroids reaches or exceeds the equivalent of 7.5 mg of prednisone and when the estimated duration of corticosteroid therapy exceeds 3 months.

In summary, in women and men over the age of 50 years, the intake of the equivalent of 7.5 mg/day or more of prednisone or a history of a low-trauma fracture or being age 70 years or older, even with a T-score less than or equal to –2.5 for one of the two sites, indicates prescribing a bisphosphonate. Teriparatide is indicated if the patient has two vertebral fractures.

This article was translated from Medscape’s French edition.

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

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The American College of Physicians has just updated its guidelines for osteoporosis treatment. Bernard Cortet, MD, PhD, chairperson of the Osteoporosis Research and Information Group and head of the rheumatology department at Lille (France) University Hospital, has agreed to compare the new U.S. guidelines to the 2018 French recommendations written under the aegis of the French Society for Rheumatology and GRIO. Dr. Cortet participated in drafting the French recommendations.

Question: The ACP “strongly” recommends initial pharmacologic treatment with bisphosphonate antiresorptive drugs (alendronate, ibandronate, risedronate, zoledronate) in postmenopausal females diagnosed with primary osteoporosis. Isn’t this what the SFR–GRIO have been recommending for many years?

Answer: The ACP reinforces its stance by arguing that in postmenopausal females with primary osteoporosis, bisphosphonates have the most favorable balance between benefits, harms, patient values and preferences, and cost among the drug classes that were evaluated. In addition to net clinical benefits, bisphosphonates are much cheaper than other pharmacologic treatments and are available in generic oral and injectable formulations.

Our French recommendations specify the choice of drug based on the type of fracture in women and on their bone mineral density (BMD). However, bisphosphonates are definitely given pride of place. When treatment for osteoporosis needs to be started, most of the time, a bisphosphonate is the treatment of choice.

Nevertheless, as also highlighted by the ACP, a more “aggressive” approach must be considered for more severe cases.

In the case of a severe fracture, the French recommendations indicate that all treatments can be prescribed. However, zoledronic acid should be favored as first-line treatment for a hip fracture. In other cases – with or without a nonsevere fracture – the therapeutic indication depends on the BMD values, and in difficult cases, on tools such as FRAX [the Fracture Risk Assessment Tool].

Our guidance strongly recommends opting for an injection in other contexts, such as significant decrease in bone density, presence of comorbidities, poor treatment compliance, brain function disorders, and polymedication.

Q. But it’s not really as simple as prescribing a bisphosphonate, is it?

A. You’re right, many people find the idea of taking bisphosphonates worrying because of associated jaw problems – osteonecrosis of the jaw – or atypical femoral fractures, based on what they’ve read on the Internet, where these serious adverse events are on display front and center with no mention of how often they actually happen and, often, failing to mention how effective bisphosphonates truly are.

These complications are real, but fortunately rare, especially during the first 5 years of treatment. To put this into context, for bisphosphonates, there’s one case of osteonecrosis of the jaw for every 10,000. And for denosumab, there are five cases for every 10,000. For atypical fractures, there’s one case for every 30,000 to 50,000.

Q. The U.S. guidelines also recommend that clinicians use a RANK ligand inhibitor – denosumab, also an antiresorptive drug – as second-line medical treatment. This is to reduce the risk of fractures in postmenopausal women diagnosed with primary osteoporosis and presenting with contraindications or side effects of bisphosphonates. Do you support the use of denosumab as second-line treatment?

A. French legislation classifies it as a second-line treatment, after bisphosphonates. However, there are arguments in favor of prescribing it as first-line treatment in some contexts. If denosumab is to be prescribed – via a twice-yearly subcutaneous injection – full compliance must be observed. If a patient is to stop taking denosumab, an opinion from a medical professional is required before treatment can be discontinued, and then treatment with bisphosphonates must be prescribed.

Q. The ACP recommends that clinicians use either a sclerostin inhibitor – romosozumab – or recombinant human parathyroid hormone – teriparatide – two anabolic agents, followed by a bisphosphonate, with the aim of reducing the risk of fractures. This is only used in women with primary osteoporosis who are at a very high risk of fracture. As romosozumab is not available in France, it’s not really worth discussing its use. Does this strategy seem advisable to you, though?

A. The main issue is what is understood by “women at a very high risk of fracture.” There’s no consensus on the definition of what constitutes a woman at a very high risk of fracture, but we can assume that it involves the combination of low BMD and at least one severe fracture.

The role of anabolic bone treatment, as [the ACP] has defined it, seems logical to me, because in cases of severe osteoporosis with fracture, the risk of recurrence is very high in the next 2-3 years. In a study comparing risedronate and teriparatide in cases of severe osteoporosis, teriparatide was more effective in reducing the recurrence of vertebral fractures.

The favorable opinion of the French National Authority for Health in relation to medical coverage for romosozumab in the treatment of severe postmenopausal osteoporosis in women under the age of 75 years with a history of severe fractures, a T-score less than –2.5, and no previous history of coronary artery disease dates to 2021. This is because medical coverage for this specific group was not listed in the marketing authorization (MA) description for this drug.

But the review by the Economic Committee for Health Products failed to reach a consensus regarding the price. Today, in theory, romosozumab can be dispensed in France by hospital pharmacies, because it is approved for use in public hospitals. Romosozumab is a very interesting drug for relatively young women, especially those with multiple vertebral fractures. This injectable treatment is more effective than teriparatide in increasing BMD values and more effective than alendronate in preventing the recurrence of fractures.

Regarding medical coverage, as it stands, in cases where patients have a T-score less than or equal to –3, the 2018 SFR–GRIO recommends starting treatment even if the patient has no fractures. In cases with severe fractures combined with very low BMD (T-score ≤ –3), injectable treatments may be used to reach a bone density target (T-score > –2.5 to –2 for the hip) at the end of the treatment plan. [These treatments include] zoledronic acid, denosumab (in case of bisphosphonate failure or intolerance), or a treatment plan with teriparatide (covered by medical insurance if the patient has at least two vertebral fractures) followed by an antiresorptive drug (bisphosphonate or denosumab).

Romosozumab is a humanized monoclonal antibody (IgG2) that binds to sclerostin and acts as an inhibitor. This increases bone formation because of the activation of [bone lining cells], the production of bone matrix by osteoblasts, and the recruitment of osteochondroprogenitor cells. Moreover, romosozumab causes changes in the expression of osteoclast mediators, which decreases bone resorption. Together, these two effects that increase bone formation and decrease bone resorption lead to the rapid increase of trabecular and cortical bone mass, as well as improvements in bone structure and strength.

Women treated with a bone anabolic agent must take an antiresorptive agent at the end of their treatment so that the benefits from the treatment remain in the long term. The French and U.S. guidelines line up on this point.

In patients with two prevalent vertebral fractures, the U.S. guidelines state that teriparatide can be prescribed as first-line treatment at diagnosis in the absence of any contraindications. We agree on this point as well.

Moreover, in women under the age of 70 years with osteoporosis requiring treatment, French experts recommend prescribing raloxifene, a selective estrogen-receptor modulator. This is if the risk of nonvertebral fracture is low, as defined by the absence of the following criteria: low hip T-score, risk of falling, and history of nonvertebral fracture. Opportunities for its use are limited, and it doesn’t even figure among the U.S. recommendations.

Q. The ACP recommends that clinicians adopt an individualized approach regarding whether to start medical treatment with a bisphosphonate in women over age 65 years with low bone mass (osteopenia) to reduce the risk of fractures. If treatment is started, they›re of the opinion that a bisphosphonate must be used. What are the recommendations in France?

A. It should be noted that this recommendation by the ACP is conditional because of the low-certainty evidence.

Here’s a brief reminder of important things to note: a T-score between –2.5 and –1 indicates osteopenia; a T-score less than or equal to –2.5 indicates osteoporosis; a T-score less than or equal to –2.5 with one or several fractures indicates severe osteoporosis. The French recommendations state that treatment is not justified if a patient’s T-score is higher than –2 and there’s no presence of fractures, even with risk factors (and/or multiple falls). For T-scores less than or equal to –2 and higher than –3, the decision to prescribe depends on the specialist.

Q. The ACP recommends that clinicians use bisphosphonates for the initial medical treatment to reduce the risk of fractures in men diagnosed with primary osteoporosis.

A. The ACP recommends that clinicians use a RANK ligand inhibitor – denosumab – as second-line medical treatment to reduce the risk of fractures in men diagnosed with primary osteoporosis who present with contraindications or who are experiencing side effects of bisphosphonates. This treatment is not covered by health insurance for men in France.

Between 20% and 25% of clinical osteoporotic fractures occur in men. After age 50 years, men are roughly 20% more likely to experience an osteoporotic fracture in their lifetime. The French recommendations regarding the management and treatment of osteoporosis in men were published in 2021.

In the case of severe fractures (vertebrae, pelvis, upper end of the femur, distal femur, proximal humerus) attributable to bone fragility, osteoporosis treatment is recommended if one of the T-scores is less than or equal to –1.

In the case of nonsevere fractures (particularly wrist and ankle) attributable to bone fragility, osteoporosis treatment is recommended if one of the T-scores is less than or equal to –2. If there are no fractures, osteoporosis treatment is recommended in men at risk of bone fragility or of falling and if one of the T-scores is less than or equal to –3. In patients who had a fracture of the upper end of the femur attributable to bone fragility, zoledronic acid is recommended as first-line treatment.

For men with a severe nonvertebral fracture, single vertebral fracture, or nonsevere fracture, two treatments are indicated and covered by health insurance in France: zoledronic acid and risedronate. In men with at least two vertebral fractures, the following treatments are indicated and covered by health insurance in France: teriparatide and risedronate. In this case, teriparatide is prescribed for a period of 18 months. It must be followed by a prescription of oral or intravenous bisphosphonates.

Q. What is your take on the HAS update to the proper use of osteoporosis medication that’s just been published?

A. Like in the 2018 SFR–GRIO guidelines, no update has been made to the section on postmenopausal osteoporosis, except for the HAS introduction to the proper use of romosozumab, even though it’s not covered by health insurance in France.

In accordance with the MA, it doesn’t make sense to include this drug on the list of treatment options available for women with and without fractures, as it’s not included in the HAS-selected list of drugs covered by health insurance in France.

But I’m glad that the HAS has adopted the GRIO and SFR recommendations regarding corticosteroid-induced osteoporosis. Preventive treatment for corticosteroid-induced osteoporosis must be considered as soon as the daily dose of corticosteroids reaches or exceeds the equivalent of 7.5 mg of prednisone and when the estimated duration of corticosteroid therapy exceeds 3 months.

In summary, in women and men over the age of 50 years, the intake of the equivalent of 7.5 mg/day or more of prednisone or a history of a low-trauma fracture or being age 70 years or older, even with a T-score less than or equal to –2.5 for one of the two sites, indicates prescribing a bisphosphonate. Teriparatide is indicated if the patient has two vertebral fractures.

This article was translated from Medscape’s French edition.

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

The American College of Physicians has just updated its guidelines for osteoporosis treatment. Bernard Cortet, MD, PhD, chairperson of the Osteoporosis Research and Information Group and head of the rheumatology department at Lille (France) University Hospital, has agreed to compare the new U.S. guidelines to the 2018 French recommendations written under the aegis of the French Society for Rheumatology and GRIO. Dr. Cortet participated in drafting the French recommendations.

Question: The ACP “strongly” recommends initial pharmacologic treatment with bisphosphonate antiresorptive drugs (alendronate, ibandronate, risedronate, zoledronate) in postmenopausal females diagnosed with primary osteoporosis. Isn’t this what the SFR–GRIO have been recommending for many years?

Answer: The ACP reinforces its stance by arguing that in postmenopausal females with primary osteoporosis, bisphosphonates have the most favorable balance between benefits, harms, patient values and preferences, and cost among the drug classes that were evaluated. In addition to net clinical benefits, bisphosphonates are much cheaper than other pharmacologic treatments and are available in generic oral and injectable formulations.

Our French recommendations specify the choice of drug based on the type of fracture in women and on their bone mineral density (BMD). However, bisphosphonates are definitely given pride of place. When treatment for osteoporosis needs to be started, most of the time, a bisphosphonate is the treatment of choice.

Nevertheless, as also highlighted by the ACP, a more “aggressive” approach must be considered for more severe cases.

In the case of a severe fracture, the French recommendations indicate that all treatments can be prescribed. However, zoledronic acid should be favored as first-line treatment for a hip fracture. In other cases – with or without a nonsevere fracture – the therapeutic indication depends on the BMD values, and in difficult cases, on tools such as FRAX [the Fracture Risk Assessment Tool].

Our guidance strongly recommends opting for an injection in other contexts, such as significant decrease in bone density, presence of comorbidities, poor treatment compliance, brain function disorders, and polymedication.

Q. But it’s not really as simple as prescribing a bisphosphonate, is it?

A. You’re right, many people find the idea of taking bisphosphonates worrying because of associated jaw problems – osteonecrosis of the jaw – or atypical femoral fractures, based on what they’ve read on the Internet, where these serious adverse events are on display front and center with no mention of how often they actually happen and, often, failing to mention how effective bisphosphonates truly are.

These complications are real, but fortunately rare, especially during the first 5 years of treatment. To put this into context, for bisphosphonates, there’s one case of osteonecrosis of the jaw for every 10,000. And for denosumab, there are five cases for every 10,000. For atypical fractures, there’s one case for every 30,000 to 50,000.

Q. The U.S. guidelines also recommend that clinicians use a RANK ligand inhibitor – denosumab, also an antiresorptive drug – as second-line medical treatment. This is to reduce the risk of fractures in postmenopausal women diagnosed with primary osteoporosis and presenting with contraindications or side effects of bisphosphonates. Do you support the use of denosumab as second-line treatment?

A. French legislation classifies it as a second-line treatment, after bisphosphonates. However, there are arguments in favor of prescribing it as first-line treatment in some contexts. If denosumab is to be prescribed – via a twice-yearly subcutaneous injection – full compliance must be observed. If a patient is to stop taking denosumab, an opinion from a medical professional is required before treatment can be discontinued, and then treatment with bisphosphonates must be prescribed.

Q. The ACP recommends that clinicians use either a sclerostin inhibitor – romosozumab – or recombinant human parathyroid hormone – teriparatide – two anabolic agents, followed by a bisphosphonate, with the aim of reducing the risk of fractures. This is only used in women with primary osteoporosis who are at a very high risk of fracture. As romosozumab is not available in France, it’s not really worth discussing its use. Does this strategy seem advisable to you, though?

A. The main issue is what is understood by “women at a very high risk of fracture.” There’s no consensus on the definition of what constitutes a woman at a very high risk of fracture, but we can assume that it involves the combination of low BMD and at least one severe fracture.

The role of anabolic bone treatment, as [the ACP] has defined it, seems logical to me, because in cases of severe osteoporosis with fracture, the risk of recurrence is very high in the next 2-3 years. In a study comparing risedronate and teriparatide in cases of severe osteoporosis, teriparatide was more effective in reducing the recurrence of vertebral fractures.

The favorable opinion of the French National Authority for Health in relation to medical coverage for romosozumab in the treatment of severe postmenopausal osteoporosis in women under the age of 75 years with a history of severe fractures, a T-score less than –2.5, and no previous history of coronary artery disease dates to 2021. This is because medical coverage for this specific group was not listed in the marketing authorization (MA) description for this drug.

But the review by the Economic Committee for Health Products failed to reach a consensus regarding the price. Today, in theory, romosozumab can be dispensed in France by hospital pharmacies, because it is approved for use in public hospitals. Romosozumab is a very interesting drug for relatively young women, especially those with multiple vertebral fractures. This injectable treatment is more effective than teriparatide in increasing BMD values and more effective than alendronate in preventing the recurrence of fractures.

Regarding medical coverage, as it stands, in cases where patients have a T-score less than or equal to –3, the 2018 SFR–GRIO recommends starting treatment even if the patient has no fractures. In cases with severe fractures combined with very low BMD (T-score ≤ –3), injectable treatments may be used to reach a bone density target (T-score > –2.5 to –2 for the hip) at the end of the treatment plan. [These treatments include] zoledronic acid, denosumab (in case of bisphosphonate failure or intolerance), or a treatment plan with teriparatide (covered by medical insurance if the patient has at least two vertebral fractures) followed by an antiresorptive drug (bisphosphonate or denosumab).

Romosozumab is a humanized monoclonal antibody (IgG2) that binds to sclerostin and acts as an inhibitor. This increases bone formation because of the activation of [bone lining cells], the production of bone matrix by osteoblasts, and the recruitment of osteochondroprogenitor cells. Moreover, romosozumab causes changes in the expression of osteoclast mediators, which decreases bone resorption. Together, these two effects that increase bone formation and decrease bone resorption lead to the rapid increase of trabecular and cortical bone mass, as well as improvements in bone structure and strength.

Women treated with a bone anabolic agent must take an antiresorptive agent at the end of their treatment so that the benefits from the treatment remain in the long term. The French and U.S. guidelines line up on this point.

In patients with two prevalent vertebral fractures, the U.S. guidelines state that teriparatide can be prescribed as first-line treatment at diagnosis in the absence of any contraindications. We agree on this point as well.

Moreover, in women under the age of 70 years with osteoporosis requiring treatment, French experts recommend prescribing raloxifene, a selective estrogen-receptor modulator. This is if the risk of nonvertebral fracture is low, as defined by the absence of the following criteria: low hip T-score, risk of falling, and history of nonvertebral fracture. Opportunities for its use are limited, and it doesn’t even figure among the U.S. recommendations.

Q. The ACP recommends that clinicians adopt an individualized approach regarding whether to start medical treatment with a bisphosphonate in women over age 65 years with low bone mass (osteopenia) to reduce the risk of fractures. If treatment is started, they›re of the opinion that a bisphosphonate must be used. What are the recommendations in France?

A. It should be noted that this recommendation by the ACP is conditional because of the low-certainty evidence.

Here’s a brief reminder of important things to note: a T-score between –2.5 and –1 indicates osteopenia; a T-score less than or equal to –2.5 indicates osteoporosis; a T-score less than or equal to –2.5 with one or several fractures indicates severe osteoporosis. The French recommendations state that treatment is not justified if a patient’s T-score is higher than –2 and there’s no presence of fractures, even with risk factors (and/or multiple falls). For T-scores less than or equal to –2 and higher than –3, the decision to prescribe depends on the specialist.

Q. The ACP recommends that clinicians use bisphosphonates for the initial medical treatment to reduce the risk of fractures in men diagnosed with primary osteoporosis.

A. The ACP recommends that clinicians use a RANK ligand inhibitor – denosumab – as second-line medical treatment to reduce the risk of fractures in men diagnosed with primary osteoporosis who present with contraindications or who are experiencing side effects of bisphosphonates. This treatment is not covered by health insurance for men in France.

Between 20% and 25% of clinical osteoporotic fractures occur in men. After age 50 years, men are roughly 20% more likely to experience an osteoporotic fracture in their lifetime. The French recommendations regarding the management and treatment of osteoporosis in men were published in 2021.

In the case of severe fractures (vertebrae, pelvis, upper end of the femur, distal femur, proximal humerus) attributable to bone fragility, osteoporosis treatment is recommended if one of the T-scores is less than or equal to –1.

In the case of nonsevere fractures (particularly wrist and ankle) attributable to bone fragility, osteoporosis treatment is recommended if one of the T-scores is less than or equal to –2. If there are no fractures, osteoporosis treatment is recommended in men at risk of bone fragility or of falling and if one of the T-scores is less than or equal to –3. In patients who had a fracture of the upper end of the femur attributable to bone fragility, zoledronic acid is recommended as first-line treatment.

For men with a severe nonvertebral fracture, single vertebral fracture, or nonsevere fracture, two treatments are indicated and covered by health insurance in France: zoledronic acid and risedronate. In men with at least two vertebral fractures, the following treatments are indicated and covered by health insurance in France: teriparatide and risedronate. In this case, teriparatide is prescribed for a period of 18 months. It must be followed by a prescription of oral or intravenous bisphosphonates.

Q. What is your take on the HAS update to the proper use of osteoporosis medication that’s just been published?

A. Like in the 2018 SFR–GRIO guidelines, no update has been made to the section on postmenopausal osteoporosis, except for the HAS introduction to the proper use of romosozumab, even though it’s not covered by health insurance in France.

In accordance with the MA, it doesn’t make sense to include this drug on the list of treatment options available for women with and without fractures, as it’s not included in the HAS-selected list of drugs covered by health insurance in France.

But I’m glad that the HAS has adopted the GRIO and SFR recommendations regarding corticosteroid-induced osteoporosis. Preventive treatment for corticosteroid-induced osteoporosis must be considered as soon as the daily dose of corticosteroids reaches or exceeds the equivalent of 7.5 mg of prednisone and when the estimated duration of corticosteroid therapy exceeds 3 months.

In summary, in women and men over the age of 50 years, the intake of the equivalent of 7.5 mg/day or more of prednisone or a history of a low-trauma fracture or being age 70 years or older, even with a T-score less than or equal to –2.5 for one of the two sites, indicates prescribing a bisphosphonate. Teriparatide is indicated if the patient has two vertebral fractures.

This article was translated from Medscape’s French edition.

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

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Back pain: Red flags and when to image

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Tue, 03/14/2023 - 17:46

 

This transcript has been edited for clarity.

Matthew F. Watto, MD: Welcome back to The Curbsiders. On tonight’s episode, we are going to be talking about back pain. This is based on an interview, Back Pain Update with Dr. Austin Baraki. He gave us some great pearls about how to manage back pain, which we see so much of in primary care. I’ll use one of my famous teaching techniques: If the patient has any kind of back pain, they should just not move. Right?

Paul N. Williams, MD: That’s right, Matt – we should recommend bedrest until they get better for anyone who has any back pain? No. For back pain, early activity and exercise are great. Patients are often concerned that physical therapy will make their pain worse, so they don’t exercise. This misunderstanding is not surprising. They believe that if they are experiencing pain, it’s facilitating more damage, which is not necessarily the case. It will get better, and a little bit of anticipatory guidance goes a long way in terms of managing patient expectations related to early mobilization, early exercise, and physical therapy.

Dr. Watto: Absolutely. One of the goals of treatment is symptom relief to the extent that we’re able to achieve. We’re not expecting the pain to go to zero. That just doesn’t happen, especially if someone’s on a medication long term. Another goal is return to function. We want them sleeping. We want them to be able to tolerate movement.

We have medications – NSAIDs and muscle relaxants, which are actually tranquilizers. But most therapy for back pain doesn’t involve medications. It involves active movement, so we have to find movement that the patient enjoys doing. Passive treatments, things being done to patients, just don’t work as well.
 

Dr. Williams: We should be clear – we’re talking primarily about chronic back pain here. For acute back pain, we actually have some decent medications, but acute back pain tends to improve no matter what you do. We don’t have much to offer pharmacologically for chronic low back pain. The best modalities usually involve physical activity of some kind.

Dr. Watto: Let’s discuss the evaluation of back pain. Something that always comes up: Should we order imaging, and is there a right time to get it? Dr. Baraki was very clear about when to do imaging. Two big buckets of patients might need imaging.

First, a patient who has a serious underlying condition and you’re using imaging to try to diagnose it; or in a chronic setting, a patient who needs surgery, and imaging is part of the presurgical evaluation. We talked about red flags.

The red flags are major trauma, where we have reason to believe there might be something going on – if we strongly suspect infection, or the patient is injecting drugs. If the patient has a history of cancer, we would be worried that they might have a recurrence. Those are some of the main red flags. With a patient who has osteoporosis or is on chronic steroids, you might even be able to get by with plain films instead of an MRI to look for fracture.

The other thing I wanted to ask you about is, when should we get imaging? Are there any pitfalls we need to worry about?
 

Dr. Williams: I always like podcasts I’m not on because I enjoy listening to them much more. Dr. Baraki talked about the very specific language that is used in radiology reports, such as spondylitis, spondylolysis, and multilevel degenerative disease. They sound bad, but if they are just reframed as age-related degenerative changes, that sounds so much more benign. When discussing with patients, we should avoid medical jargon and say that we saw some changes that we would expect for someone of your age. That sounds so much better than saying we saw multilevel degenerative disease, which sounds like an alarming pathology if you’re not a physician. Without being inaccurate, we should frame the discussion such that we aren’t providing a very specific diagnosis, because that is rarely the case with chronic low back pain. Typically, many things are going on and you may never identify a single unifying diagnosis, which doesn’t tend to help anyway.

Dr. Watto: There’s evidence showing that if the radiology report uses clinical terminology that both clinician and patient think of as less serious, they are less likely to proceed to more invasive treatments. Calling an episode of back pain a “lumbar strain” helps the patient understand that this is a pretty common thing. Almost everyone is going to have an episode of back pain at some point in their life, and almost all of them will get better. Most of the time there’s no serious underlying condition.

This was a great discussion with Dr. Baraki. Click on Back Pain Update with Dr Austin Baraki to hear the full discussion. Until next time, I’ve been Dr. Matthew Frank Watto.
 

Dr. Williams: And I’m Dr. Paul Nelson Williams.

Dr. Watto is Clinical Assistant Professor, Department of Medicine, University of Pennsylvania, Philadelphia. Dr. Williams is Associate Professor of Clinical Medicine, Department of General Internal Medicine, Temple University, Philadelphia. Neither reported any conflicts of interest.

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

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This transcript has been edited for clarity.

Matthew F. Watto, MD: Welcome back to The Curbsiders. On tonight’s episode, we are going to be talking about back pain. This is based on an interview, Back Pain Update with Dr. Austin Baraki. He gave us some great pearls about how to manage back pain, which we see so much of in primary care. I’ll use one of my famous teaching techniques: If the patient has any kind of back pain, they should just not move. Right?

Paul N. Williams, MD: That’s right, Matt – we should recommend bedrest until they get better for anyone who has any back pain? No. For back pain, early activity and exercise are great. Patients are often concerned that physical therapy will make their pain worse, so they don’t exercise. This misunderstanding is not surprising. They believe that if they are experiencing pain, it’s facilitating more damage, which is not necessarily the case. It will get better, and a little bit of anticipatory guidance goes a long way in terms of managing patient expectations related to early mobilization, early exercise, and physical therapy.

Dr. Watto: Absolutely. One of the goals of treatment is symptom relief to the extent that we’re able to achieve. We’re not expecting the pain to go to zero. That just doesn’t happen, especially if someone’s on a medication long term. Another goal is return to function. We want them sleeping. We want them to be able to tolerate movement.

We have medications – NSAIDs and muscle relaxants, which are actually tranquilizers. But most therapy for back pain doesn’t involve medications. It involves active movement, so we have to find movement that the patient enjoys doing. Passive treatments, things being done to patients, just don’t work as well.
 

Dr. Williams: We should be clear – we’re talking primarily about chronic back pain here. For acute back pain, we actually have some decent medications, but acute back pain tends to improve no matter what you do. We don’t have much to offer pharmacologically for chronic low back pain. The best modalities usually involve physical activity of some kind.

Dr. Watto: Let’s discuss the evaluation of back pain. Something that always comes up: Should we order imaging, and is there a right time to get it? Dr. Baraki was very clear about when to do imaging. Two big buckets of patients might need imaging.

First, a patient who has a serious underlying condition and you’re using imaging to try to diagnose it; or in a chronic setting, a patient who needs surgery, and imaging is part of the presurgical evaluation. We talked about red flags.

The red flags are major trauma, where we have reason to believe there might be something going on – if we strongly suspect infection, or the patient is injecting drugs. If the patient has a history of cancer, we would be worried that they might have a recurrence. Those are some of the main red flags. With a patient who has osteoporosis or is on chronic steroids, you might even be able to get by with plain films instead of an MRI to look for fracture.

The other thing I wanted to ask you about is, when should we get imaging? Are there any pitfalls we need to worry about?
 

Dr. Williams: I always like podcasts I’m not on because I enjoy listening to them much more. Dr. Baraki talked about the very specific language that is used in radiology reports, such as spondylitis, spondylolysis, and multilevel degenerative disease. They sound bad, but if they are just reframed as age-related degenerative changes, that sounds so much more benign. When discussing with patients, we should avoid medical jargon and say that we saw some changes that we would expect for someone of your age. That sounds so much better than saying we saw multilevel degenerative disease, which sounds like an alarming pathology if you’re not a physician. Without being inaccurate, we should frame the discussion such that we aren’t providing a very specific diagnosis, because that is rarely the case with chronic low back pain. Typically, many things are going on and you may never identify a single unifying diagnosis, which doesn’t tend to help anyway.

Dr. Watto: There’s evidence showing that if the radiology report uses clinical terminology that both clinician and patient think of as less serious, they are less likely to proceed to more invasive treatments. Calling an episode of back pain a “lumbar strain” helps the patient understand that this is a pretty common thing. Almost everyone is going to have an episode of back pain at some point in their life, and almost all of them will get better. Most of the time there’s no serious underlying condition.

This was a great discussion with Dr. Baraki. Click on Back Pain Update with Dr Austin Baraki to hear the full discussion. Until next time, I’ve been Dr. Matthew Frank Watto.
 

Dr. Williams: And I’m Dr. Paul Nelson Williams.

Dr. Watto is Clinical Assistant Professor, Department of Medicine, University of Pennsylvania, Philadelphia. Dr. Williams is Associate Professor of Clinical Medicine, Department of General Internal Medicine, Temple University, Philadelphia. Neither reported any conflicts of interest.

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

 

This transcript has been edited for clarity.

Matthew F. Watto, MD: Welcome back to The Curbsiders. On tonight’s episode, we are going to be talking about back pain. This is based on an interview, Back Pain Update with Dr. Austin Baraki. He gave us some great pearls about how to manage back pain, which we see so much of in primary care. I’ll use one of my famous teaching techniques: If the patient has any kind of back pain, they should just not move. Right?

Paul N. Williams, MD: That’s right, Matt – we should recommend bedrest until they get better for anyone who has any back pain? No. For back pain, early activity and exercise are great. Patients are often concerned that physical therapy will make their pain worse, so they don’t exercise. This misunderstanding is not surprising. They believe that if they are experiencing pain, it’s facilitating more damage, which is not necessarily the case. It will get better, and a little bit of anticipatory guidance goes a long way in terms of managing patient expectations related to early mobilization, early exercise, and physical therapy.

Dr. Watto: Absolutely. One of the goals of treatment is symptom relief to the extent that we’re able to achieve. We’re not expecting the pain to go to zero. That just doesn’t happen, especially if someone’s on a medication long term. Another goal is return to function. We want them sleeping. We want them to be able to tolerate movement.

We have medications – NSAIDs and muscle relaxants, which are actually tranquilizers. But most therapy for back pain doesn’t involve medications. It involves active movement, so we have to find movement that the patient enjoys doing. Passive treatments, things being done to patients, just don’t work as well.
 

Dr. Williams: We should be clear – we’re talking primarily about chronic back pain here. For acute back pain, we actually have some decent medications, but acute back pain tends to improve no matter what you do. We don’t have much to offer pharmacologically for chronic low back pain. The best modalities usually involve physical activity of some kind.

Dr. Watto: Let’s discuss the evaluation of back pain. Something that always comes up: Should we order imaging, and is there a right time to get it? Dr. Baraki was very clear about when to do imaging. Two big buckets of patients might need imaging.

First, a patient who has a serious underlying condition and you’re using imaging to try to diagnose it; or in a chronic setting, a patient who needs surgery, and imaging is part of the presurgical evaluation. We talked about red flags.

The red flags are major trauma, where we have reason to believe there might be something going on – if we strongly suspect infection, or the patient is injecting drugs. If the patient has a history of cancer, we would be worried that they might have a recurrence. Those are some of the main red flags. With a patient who has osteoporosis or is on chronic steroids, you might even be able to get by with plain films instead of an MRI to look for fracture.

The other thing I wanted to ask you about is, when should we get imaging? Are there any pitfalls we need to worry about?
 

Dr. Williams: I always like podcasts I’m not on because I enjoy listening to them much more. Dr. Baraki talked about the very specific language that is used in radiology reports, such as spondylitis, spondylolysis, and multilevel degenerative disease. They sound bad, but if they are just reframed as age-related degenerative changes, that sounds so much more benign. When discussing with patients, we should avoid medical jargon and say that we saw some changes that we would expect for someone of your age. That sounds so much better than saying we saw multilevel degenerative disease, which sounds like an alarming pathology if you’re not a physician. Without being inaccurate, we should frame the discussion such that we aren’t providing a very specific diagnosis, because that is rarely the case with chronic low back pain. Typically, many things are going on and you may never identify a single unifying diagnosis, which doesn’t tend to help anyway.

Dr. Watto: There’s evidence showing that if the radiology report uses clinical terminology that both clinician and patient think of as less serious, they are less likely to proceed to more invasive treatments. Calling an episode of back pain a “lumbar strain” helps the patient understand that this is a pretty common thing. Almost everyone is going to have an episode of back pain at some point in their life, and almost all of them will get better. Most of the time there’s no serious underlying condition.

This was a great discussion with Dr. Baraki. Click on Back Pain Update with Dr Austin Baraki to hear the full discussion. Until next time, I’ve been Dr. Matthew Frank Watto.
 

Dr. Williams: And I’m Dr. Paul Nelson Williams.

Dr. Watto is Clinical Assistant Professor, Department of Medicine, University of Pennsylvania, Philadelphia. Dr. Williams is Associate Professor of Clinical Medicine, Department of General Internal Medicine, Temple University, Philadelphia. Neither reported any conflicts of interest.

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

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