MDedge Endocrinology

In the first randomized controlled trial of prednisone for postvasectomy reversals, fertility researchers found that a high dose of the steroid reduced the rate of subsequent pregnancy.

“This is the first time it’s been shown that high doses [of prednisone] can make someone infertile,” said Landon Trost, MD, director of the Male Fertility and Peyronie’s Clinic in Orem, Utah, and a faculty member at Mayo Clinic, in Rochester, Minnesota, who presented the study (Abstract MP42-19) on May 4 at the 2024 annual meeting of the American Urological Association (AUA) in San Antonio, Texas. 

Dr. Trost called the findings “a real shock. I almost didn’t believe the data when I saw it. It opens up a whole new set of areas for research and exploration.”

Dr. Trost’s clinic performs 1200 reversals per year out of the estimated 20,000 performed annually in the United States, he said. He said his practice has stopped using high-dose prednisone as a result of the study, which he performed at his own expense to examine the varying protocols for vasectomy reversal.

William Berg, MD, director of the Stony Brook Urology Men’s Health Program, in Stony Brook, New York, said that the expected patency rate for modern postvasectomy reversals, if performed properly, can be as high as 98%. However, in some men, patency occurs initially, but the accumulation of scar tissue at the site of reversal causes sperm counts in ejaculate to drop to zero.

Since the 1970s, urologists — with limited research to back — the practice  prescribed prednisone to patients with the goal of preventing scarring and blockages associated with vasectomy reversals. Dr. Berg called this practice “unsubstantiated” and noted that Dr. Trost’s study is the first prospective randomized controlled trial of this approach.

The study enrolled 75 men, with a mean age of roughly 38 years. The mean time since vasectomy was 6.6 years.

The low-dose arm (25 patients) received 5 mg of prednisone per week alternating with no treatment per week over 6 months. The high-dose arm (n = 14) received 20 mg of prednisone, tapered to 10 mg, 5 mg, and then off over 1 month, followed by every other month for 6 months. A prednisone-as-needed group (n = 11) received a tapered course of prednisone on the basis of whether they had decreasing or zero sperm counts. They received 20 mg for 5 days, 10 mg for 5 days, and 5 mg for 20 days.

A control arm (n = 25) received no prednisone.

Urologists typically use patency rates to measure success of vasectomy reversals. The patency rates at 12 months in Dr. Trost’s study were 100% in the control participants, prednisone-as-needed, and low-dose groups and 92% (13/14) in the high-dose group. 

Dr. Trost said that the story was told in the pregnancy rates. At the 1-year mark, pregnancy rates were 67% in the low-risk group and 65% in the control group but 38% and 17% in the prednisone-as-needed and high-dose group, respectively (P = .02).

The mean maximum sperm concentration was 40 million per mL, ranging from 29.7 million per mL for men in the control group to 54.3 million per mL in the low-dose group.

Dr. Trost said that he immediately stopped using high doses of prednisone in his practice and predicted that other clinics would follow suit. 

Dr. Berg said the drop in pregnancies with higher doses of prednisone is a first-time finding and suggests that a high dose may “be detrimental to sperm function in some way. I don’t think this ever has been described before.”

Dr. Trost financed the study himself. Dr. Berg reported no conflicts.

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

In the first randomized controlled trial of prednisone for postvasectomy reversals, fertility researchers found that a high dose of the steroid reduced the rate of subsequent pregnancy.

“This is the first time it’s been shown that high doses [of prednisone] can make someone infertile,” said Landon Trost, MD, director of the Male Fertility and Peyronie’s Clinic in Orem, Utah, and a faculty member at Mayo Clinic, in Rochester, Minnesota, who presented the study (Abstract MP42-19) on May 4 at the 2024 annual meeting of the American Urological Association (AUA) in San Antonio, Texas. 

Dr. Trost called the findings “a real shock. I almost didn’t believe the data when I saw it. It opens up a whole new set of areas for research and exploration.”

Dr. Trost’s clinic performs 1200 reversals per year out of the estimated 20,000 performed annually in the United States, he said. He said his practice has stopped using high-dose prednisone as a result of the study, which he performed at his own expense to examine the varying protocols for vasectomy reversal.

William Berg, MD, director of the Stony Brook Urology Men’s Health Program, in Stony Brook, New York, said that the expected patency rate for modern postvasectomy reversals, if performed properly, can be as high as 98%. However, in some men, patency occurs initially, but the accumulation of scar tissue at the site of reversal causes sperm counts in ejaculate to drop to zero.

Since the 1970s, urologists — with limited research to back — the practice  prescribed prednisone to patients with the goal of preventing scarring and blockages associated with vasectomy reversals. Dr. Berg called this practice “unsubstantiated” and noted that Dr. Trost’s study is the first prospective randomized controlled trial of this approach.

The study enrolled 75 men, with a mean age of roughly 38 years. The mean time since vasectomy was 6.6 years.

The low-dose arm (25 patients) received 5 mg of prednisone per week alternating with no treatment per week over 6 months. The high-dose arm (n = 14) received 20 mg of prednisone, tapered to 10 mg, 5 mg, and then off over 1 month, followed by every other month for 6 months. A prednisone-as-needed group (n = 11) received a tapered course of prednisone on the basis of whether they had decreasing or zero sperm counts. They received 20 mg for 5 days, 10 mg for 5 days, and 5 mg for 20 days.

A control arm (n = 25) received no prednisone.

Urologists typically use patency rates to measure success of vasectomy reversals. The patency rates at 12 months in Dr. Trost’s study were 100% in the control participants, prednisone-as-needed, and low-dose groups and 92% (13/14) in the high-dose group. 

Dr. Trost said that the story was told in the pregnancy rates. At the 1-year mark, pregnancy rates were 67% in the low-risk group and 65% in the control group but 38% and 17% in the prednisone-as-needed and high-dose group, respectively (P = .02).

The mean maximum sperm concentration was 40 million per mL, ranging from 29.7 million per mL for men in the control group to 54.3 million per mL in the low-dose group.

Dr. Trost said that he immediately stopped using high doses of prednisone in his practice and predicted that other clinics would follow suit. 

Dr. Berg said the drop in pregnancies with higher doses of prednisone is a first-time finding and suggests that a high dose may “be detrimental to sperm function in some way. I don’t think this ever has been described before.”

Dr. Trost financed the study himself. Dr. Berg reported no conflicts.

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

In the first randomized controlled trial of prednisone for postvasectomy reversals, fertility researchers found that a high dose of the steroid reduced the rate of subsequent pregnancy.

“This is the first time it’s been shown that high doses [of prednisone] can make someone infertile,” said Landon Trost, MD, director of the Male Fertility and Peyronie’s Clinic in Orem, Utah, and a faculty member at Mayo Clinic, in Rochester, Minnesota, who presented the study (Abstract MP42-19) on May 4 at the 2024 annual meeting of the American Urological Association (AUA) in San Antonio, Texas. 

Dr. Trost called the findings “a real shock. I almost didn’t believe the data when I saw it. It opens up a whole new set of areas for research and exploration.”

Dr. Trost’s clinic performs 1200 reversals per year out of the estimated 20,000 performed annually in the United States, he said. He said his practice has stopped using high-dose prednisone as a result of the study, which he performed at his own expense to examine the varying protocols for vasectomy reversal.

William Berg, MD, director of the Stony Brook Urology Men’s Health Program, in Stony Brook, New York, said that the expected patency rate for modern postvasectomy reversals, if performed properly, can be as high as 98%. However, in some men, patency occurs initially, but the accumulation of scar tissue at the site of reversal causes sperm counts in ejaculate to drop to zero.

Since the 1970s, urologists — with limited research to back — the practice  prescribed prednisone to patients with the goal of preventing scarring and blockages associated with vasectomy reversals. Dr. Berg called this practice “unsubstantiated” and noted that Dr. Trost’s study is the first prospective randomized controlled trial of this approach.

The study enrolled 75 men, with a mean age of roughly 38 years. The mean time since vasectomy was 6.6 years.

The low-dose arm (25 patients) received 5 mg of prednisone per week alternating with no treatment per week over 6 months. The high-dose arm (n = 14) received 20 mg of prednisone, tapered to 10 mg, 5 mg, and then off over 1 month, followed by every other month for 6 months. A prednisone-as-needed group (n = 11) received a tapered course of prednisone on the basis of whether they had decreasing or zero sperm counts. They received 20 mg for 5 days, 10 mg for 5 days, and 5 mg for 20 days.

A control arm (n = 25) received no prednisone.

Urologists typically use patency rates to measure success of vasectomy reversals. The patency rates at 12 months in Dr. Trost’s study were 100% in the control participants, prednisone-as-needed, and low-dose groups and 92% (13/14) in the high-dose group. 

Dr. Trost said that the story was told in the pregnancy rates. At the 1-year mark, pregnancy rates were 67% in the low-risk group and 65% in the control group but 38% and 17% in the prednisone-as-needed and high-dose group, respectively (P = .02).

The mean maximum sperm concentration was 40 million per mL, ranging from 29.7 million per mL for men in the control group to 54.3 million per mL in the low-dose group.

Dr. Trost said that he immediately stopped using high doses of prednisone in his practice and predicted that other clinics would follow suit. 

Dr. Berg said the drop in pregnancies with higher doses of prednisone is a first-time finding and suggests that a high dose may “be detrimental to sperm function in some way. I don’t think this ever has been described before.”

Dr. Trost financed the study himself. Dr. Berg reported no conflicts.

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

A plastic surgeon broke federal law when he restricted patients from posting negative reviews by requiring them to sign nondisclosure agreements before they received care, a district judge has ruled.

Seattle-based surgeon Javad Sajan, MD, ran afoul of the Consumer Review Fairness Act (CRFA) by requiring more than 10,000 patients to sign the agreements, according to a recent decision by US District Judge Ricardo S. Martinez. The law protects consumers’ rights to post truthful reviews about businesses. 

Judge Martinez wrote that the terms of Dr. Sajan’s nondisclosure agreements “clearly include language prohibiting or restricting patients from posting negative reviews,” in violation of CRFA. Penalties for the offense will be determined at a September trial. 

This news organization contacted Dr. Sajan’s office and his attorney for comment but did not get a response. 

The decision is the latest development in an ongoing legal dispute between Dr. Sajan and the State of Washington over whether the surgeon’s efforts to limit negative online reviews were illegal. 

Beginning in 2017, Dr. Sajan and his practice, Allure Esthetic, introduced agreements that “forced” patients to contact the business directly if they had concerns rather than post a negative review, according to a 2022 lawsuit against Dr. Sajan filed by Washington Attorney General Robert Ferguson. 

“Online reviews are often the first stop when consumers are determining who to trust,” Mr. Ferguson said in a statement. “That’s especially critical when those services deal with a patient’s health and safety. We will take action against those who illegally stop Washingtonians from sharing reviews with the public.”

If patients posted negative reviews, the clinic, in some cases, threatened litigation, according to the complaint. In other cases, patients were allegedly offered money and free services in exchange for taking the reviews down. Patients who accepted cash or services were required to sign a second agreement forbidding them from posting future negative reviews and imposing a $250,000 penalty for failure to comply, according to court documents. 

In court documents, Dr. Sajan’s attorneys argued the agreements did not violate CRFA because patients had the opportunity to modify the language or decline signing them, which hundreds did. The CRFA requires Mr. Ferguson to prove that consumers lacked a meaningful opportunity to negotiate the terms, attorneys for Dr. Sajan argued in court records. 

But Judge Martinez wrote that the patients who declined to sign the agreements or changed the terms represented only a “tiny fraction” of the affected patients.

The agreement language restricts patients from speaking out by forcing dissatisfied patients to work with Allure until a resolution is reached, Judge Martinez noted in his decision. “At the very least, this would delay patients from posting such reviews and force patients to interact in some way with Allure, and it certainly appears to prohibit posting reviews until Allure agrees to some kind of favorable resolution.”
 

Surgeon Posted Fake Positive Reviews to Counteract Bad Reviews, AG Says

Employee accounts in court documents describe a physician fixated on reviews who went to great lengths to ensure positive reviews about his work outweighed the negative. 

Former employees said they were instructed to track down patients who left negative reviews and either “threaten” them to take the posts down or offer them “money” or other things, according to Mr. Ferguson’s lawsuit. If patients could not be identified, the practice would file a defamation lawsuit against the anonymous person who posted the review and use litigation to subpoena the website for the reviewer’s IP address in order to identify them, according to court documents. 

Employees testified they had regular meetings to review current negative reviews and discuss what steps they were taking to get them removed. At team meetings, in-house counsel would regularly present an Excel spreadsheet with updates on progress in getting patients to remove negative reviews, according to court documents. 

In addition to restricting negative reviews, Mr. Ferguson accuses Dr. Sajan of posting fake positive reviews and “buying” thousands of fake followers on social media. 

At Dr. Sajan’s direction, employees created Gmail accounts using stock photos for their profile pictures and used the accounts to post fake reviews of Allure Esthetic and Dr. Sajan, according to the complaint. The practice also used members of an online forum called BlackHatWorld.com to create fake email accounts and to post fake reviews, the attorney general alleges. Many of the fake positive reviews, including the fake Google reviews, still appear on online review sites today, the attorney general contends. 

Dr. Sajan and his practice also allegedly manipulated social media to appear more popular. Mr. Ferguson claims that Dr. Sajan instructed his former web designer to purchase 60,000 followers through a vendor on BlackHatWorld.com. Most of Dr. Sajan’s current Instagram followers are not real, according to Mr. Ferguson. 

The practice also used a social media bot tool to buy thousands of fake likes on Instagram, YouTube, and other social media, according to court documents. 

In addition, Dr. Sajan and his practice are accused of significantly altering “before and after” photos of patients and using fake email accounts to allow the clinic to take skincare rebates intended for patients.

All of these practices violated HIPAA, the state Consumer Protection Act (CPA) and the federal CRFA, according to Mr. Ferguson. 
 

Surgeon Claims Competitor Behind Allegations 

Attorneys for Dr. Sajan argue a competitor is behind the accusations and that other regulatory entities determined the practice did nothing wrong. 

The competitor, a Seattle-based plastic surgeon, filed numerous complaints about Dr. Sajan to the Washington Medical Commission (WMC), according to court documents. The medical commission reviewed the third agreement and closed its investigation, finding that if the allegations were true, “no violation of law occurred,” court records show. 

“Defendants relied upon this closing code from the WMC that the (non-disclosure) forms were lawful,” Dr. Sajan’s attorneys wrote in court documents.

The US Department of Health & Human Services Office for Civil Rights (OCR) also reviewed and audited Dr. Sajan’s use of the agreements, his attorneys noted. In a notice from OCR included in court exhibits, the agency wrote that all matters at issue have now been resolved through the practice’s voluntary compliance actions and that it was closing its investigation. 

Attorneys for Dr. Sajan accuse Mr. Ferguson and state investigators of withholding the full extent of the competitor’s involvement in their investigation and failing to identify the competitor in written discovery or any of its initial disclosures. Dr. Sajan and his team discovered that the competitor was a source of key information through public records requests, according to court documents. 

The remaining claims against Dr. Sajan will be addressed at trial, set for September 9, 2024. 
 

A version of this article appeared on Medscape.com.

A plastic surgeon broke federal law when he restricted patients from posting negative reviews by requiring them to sign nondisclosure agreements before they received care, a district judge has ruled.

Seattle-based surgeon Javad Sajan, MD, ran afoul of the Consumer Review Fairness Act (CRFA) by requiring more than 10,000 patients to sign the agreements, according to a recent decision by US District Judge Ricardo S. Martinez. The law protects consumers’ rights to post truthful reviews about businesses. 

Judge Martinez wrote that the terms of Dr. Sajan’s nondisclosure agreements “clearly include language prohibiting or restricting patients from posting negative reviews,” in violation of CRFA. Penalties for the offense will be determined at a September trial. 

This news organization contacted Dr. Sajan’s office and his attorney for comment but did not get a response. 

The decision is the latest development in an ongoing legal dispute between Dr. Sajan and the State of Washington over whether the surgeon’s efforts to limit negative online reviews were illegal. 

Beginning in 2017, Dr. Sajan and his practice, Allure Esthetic, introduced agreements that “forced” patients to contact the business directly if they had concerns rather than post a negative review, according to a 2022 lawsuit against Dr. Sajan filed by Washington Attorney General Robert Ferguson. 

“Online reviews are often the first stop when consumers are determining who to trust,” Mr. Ferguson said in a statement. “That’s especially critical when those services deal with a patient’s health and safety. We will take action against those who illegally stop Washingtonians from sharing reviews with the public.”

If patients posted negative reviews, the clinic, in some cases, threatened litigation, according to the complaint. In other cases, patients were allegedly offered money and free services in exchange for taking the reviews down. Patients who accepted cash or services were required to sign a second agreement forbidding them from posting future negative reviews and imposing a $250,000 penalty for failure to comply, according to court documents. 

In court documents, Dr. Sajan’s attorneys argued the agreements did not violate CRFA because patients had the opportunity to modify the language or decline signing them, which hundreds did. The CRFA requires Mr. Ferguson to prove that consumers lacked a meaningful opportunity to negotiate the terms, attorneys for Dr. Sajan argued in court records. 

But Judge Martinez wrote that the patients who declined to sign the agreements or changed the terms represented only a “tiny fraction” of the affected patients.

The agreement language restricts patients from speaking out by forcing dissatisfied patients to work with Allure until a resolution is reached, Judge Martinez noted in his decision. “At the very least, this would delay patients from posting such reviews and force patients to interact in some way with Allure, and it certainly appears to prohibit posting reviews until Allure agrees to some kind of favorable resolution.”
 

Surgeon Posted Fake Positive Reviews to Counteract Bad Reviews, AG Says

Employee accounts in court documents describe a physician fixated on reviews who went to great lengths to ensure positive reviews about his work outweighed the negative. 

Former employees said they were instructed to track down patients who left negative reviews and either “threaten” them to take the posts down or offer them “money” or other things, according to Mr. Ferguson’s lawsuit. If patients could not be identified, the practice would file a defamation lawsuit against the anonymous person who posted the review and use litigation to subpoena the website for the reviewer’s IP address in order to identify them, according to court documents. 

Employees testified they had regular meetings to review current negative reviews and discuss what steps they were taking to get them removed. At team meetings, in-house counsel would regularly present an Excel spreadsheet with updates on progress in getting patients to remove negative reviews, according to court documents. 

In addition to restricting negative reviews, Mr. Ferguson accuses Dr. Sajan of posting fake positive reviews and “buying” thousands of fake followers on social media. 

At Dr. Sajan’s direction, employees created Gmail accounts using stock photos for their profile pictures and used the accounts to post fake reviews of Allure Esthetic and Dr. Sajan, according to the complaint. The practice also used members of an online forum called BlackHatWorld.com to create fake email accounts and to post fake reviews, the attorney general alleges. Many of the fake positive reviews, including the fake Google reviews, still appear on online review sites today, the attorney general contends. 

Dr. Sajan and his practice also allegedly manipulated social media to appear more popular. Mr. Ferguson claims that Dr. Sajan instructed his former web designer to purchase 60,000 followers through a vendor on BlackHatWorld.com. Most of Dr. Sajan’s current Instagram followers are not real, according to Mr. Ferguson. 

The practice also used a social media bot tool to buy thousands of fake likes on Instagram, YouTube, and other social media, according to court documents. 

In addition, Dr. Sajan and his practice are accused of significantly altering “before and after” photos of patients and using fake email accounts to allow the clinic to take skincare rebates intended for patients.

All of these practices violated HIPAA, the state Consumer Protection Act (CPA) and the federal CRFA, according to Mr. Ferguson. 
 

Surgeon Claims Competitor Behind Allegations 

Attorneys for Dr. Sajan argue a competitor is behind the accusations and that other regulatory entities determined the practice did nothing wrong. 

The competitor, a Seattle-based plastic surgeon, filed numerous complaints about Dr. Sajan to the Washington Medical Commission (WMC), according to court documents. The medical commission reviewed the third agreement and closed its investigation, finding that if the allegations were true, “no violation of law occurred,” court records show. 

“Defendants relied upon this closing code from the WMC that the (non-disclosure) forms were lawful,” Dr. Sajan’s attorneys wrote in court documents.

The US Department of Health & Human Services Office for Civil Rights (OCR) also reviewed and audited Dr. Sajan’s use of the agreements, his attorneys noted. In a notice from OCR included in court exhibits, the agency wrote that all matters at issue have now been resolved through the practice’s voluntary compliance actions and that it was closing its investigation. 

Attorneys for Dr. Sajan accuse Mr. Ferguson and state investigators of withholding the full extent of the competitor’s involvement in their investigation and failing to identify the competitor in written discovery or any of its initial disclosures. Dr. Sajan and his team discovered that the competitor was a source of key information through public records requests, according to court documents. 

The remaining claims against Dr. Sajan will be addressed at trial, set for September 9, 2024. 
 

A version of this article appeared on Medscape.com.

A plastic surgeon broke federal law when he restricted patients from posting negative reviews by requiring them to sign nondisclosure agreements before they received care, a district judge has ruled.

Seattle-based surgeon Javad Sajan, MD, ran afoul of the Consumer Review Fairness Act (CRFA) by requiring more than 10,000 patients to sign the agreements, according to a recent decision by US District Judge Ricardo S. Martinez. The law protects consumers’ rights to post truthful reviews about businesses. 

Judge Martinez wrote that the terms of Dr. Sajan’s nondisclosure agreements “clearly include language prohibiting or restricting patients from posting negative reviews,” in violation of CRFA. Penalties for the offense will be determined at a September trial. 

This news organization contacted Dr. Sajan’s office and his attorney for comment but did not get a response. 

The decision is the latest development in an ongoing legal dispute between Dr. Sajan and the State of Washington over whether the surgeon’s efforts to limit negative online reviews were illegal. 

Beginning in 2017, Dr. Sajan and his practice, Allure Esthetic, introduced agreements that “forced” patients to contact the business directly if they had concerns rather than post a negative review, according to a 2022 lawsuit against Dr. Sajan filed by Washington Attorney General Robert Ferguson. 

“Online reviews are often the first stop when consumers are determining who to trust,” Mr. Ferguson said in a statement. “That’s especially critical when those services deal with a patient’s health and safety. We will take action against those who illegally stop Washingtonians from sharing reviews with the public.”

If patients posted negative reviews, the clinic, in some cases, threatened litigation, according to the complaint. In other cases, patients were allegedly offered money and free services in exchange for taking the reviews down. Patients who accepted cash or services were required to sign a second agreement forbidding them from posting future negative reviews and imposing a $250,000 penalty for failure to comply, according to court documents. 

In court documents, Dr. Sajan’s attorneys argued the agreements did not violate CRFA because patients had the opportunity to modify the language or decline signing them, which hundreds did. The CRFA requires Mr. Ferguson to prove that consumers lacked a meaningful opportunity to negotiate the terms, attorneys for Dr. Sajan argued in court records. 

But Judge Martinez wrote that the patients who declined to sign the agreements or changed the terms represented only a “tiny fraction” of the affected patients.

The agreement language restricts patients from speaking out by forcing dissatisfied patients to work with Allure until a resolution is reached, Judge Martinez noted in his decision. “At the very least, this would delay patients from posting such reviews and force patients to interact in some way with Allure, and it certainly appears to prohibit posting reviews until Allure agrees to some kind of favorable resolution.”
 

Surgeon Posted Fake Positive Reviews to Counteract Bad Reviews, AG Says

Employee accounts in court documents describe a physician fixated on reviews who went to great lengths to ensure positive reviews about his work outweighed the negative. 

Former employees said they were instructed to track down patients who left negative reviews and either “threaten” them to take the posts down or offer them “money” or other things, according to Mr. Ferguson’s lawsuit. If patients could not be identified, the practice would file a defamation lawsuit against the anonymous person who posted the review and use litigation to subpoena the website for the reviewer’s IP address in order to identify them, according to court documents. 

Employees testified they had regular meetings to review current negative reviews and discuss what steps they were taking to get them removed. At team meetings, in-house counsel would regularly present an Excel spreadsheet with updates on progress in getting patients to remove negative reviews, according to court documents. 

In addition to restricting negative reviews, Mr. Ferguson accuses Dr. Sajan of posting fake positive reviews and “buying” thousands of fake followers on social media. 

At Dr. Sajan’s direction, employees created Gmail accounts using stock photos for their profile pictures and used the accounts to post fake reviews of Allure Esthetic and Dr. Sajan, according to the complaint. The practice also used members of an online forum called BlackHatWorld.com to create fake email accounts and to post fake reviews, the attorney general alleges. Many of the fake positive reviews, including the fake Google reviews, still appear on online review sites today, the attorney general contends. 

Dr. Sajan and his practice also allegedly manipulated social media to appear more popular. Mr. Ferguson claims that Dr. Sajan instructed his former web designer to purchase 60,000 followers through a vendor on BlackHatWorld.com. Most of Dr. Sajan’s current Instagram followers are not real, according to Mr. Ferguson. 

The practice also used a social media bot tool to buy thousands of fake likes on Instagram, YouTube, and other social media, according to court documents. 

In addition, Dr. Sajan and his practice are accused of significantly altering “before and after” photos of patients and using fake email accounts to allow the clinic to take skincare rebates intended for patients.

All of these practices violated HIPAA, the state Consumer Protection Act (CPA) and the federal CRFA, according to Mr. Ferguson. 
 

Surgeon Claims Competitor Behind Allegations 

Attorneys for Dr. Sajan argue a competitor is behind the accusations and that other regulatory entities determined the practice did nothing wrong. 

The competitor, a Seattle-based plastic surgeon, filed numerous complaints about Dr. Sajan to the Washington Medical Commission (WMC), according to court documents. The medical commission reviewed the third agreement and closed its investigation, finding that if the allegations were true, “no violation of law occurred,” court records show. 

“Defendants relied upon this closing code from the WMC that the (non-disclosure) forms were lawful,” Dr. Sajan’s attorneys wrote in court documents.

The US Department of Health & Human Services Office for Civil Rights (OCR) also reviewed and audited Dr. Sajan’s use of the agreements, his attorneys noted. In a notice from OCR included in court exhibits, the agency wrote that all matters at issue have now been resolved through the practice’s voluntary compliance actions and that it was closing its investigation. 

Attorneys for Dr. Sajan accuse Mr. Ferguson and state investigators of withholding the full extent of the competitor’s involvement in their investigation and failing to identify the competitor in written discovery or any of its initial disclosures. Dr. Sajan and his team discovered that the competitor was a source of key information through public records requests, according to court documents. 

The remaining claims against Dr. Sajan will be addressed at trial, set for September 9, 2024. 
 

A version of this article appeared on Medscape.com.

CHICAGO — The diabetes/weight loss drug semaglutide is associated with a significantly greater risk for repeat operations in patients with diabetes who require lumbar surgery, a new study suggests.

The risk for additional surgeries was even higher among patients taking the popular weight loss and diabetes drug for longer periods of time.

Investigators say the study provides the first evidence on the impact of semaglutide on spine surgery. 

“The expectation was [that] we would see patients doing better after surgery, less wound complications, and other things, and in our diabetic patients we did not see that and saw increased odds of needing additional surgeries,” investigator Syed I. Khalid, MD, neurosurgery resident at University of Illinois Chicago, told this news organization.

The findings were presented on May 3 at the American Association of Neurological Surgeons (AANS) 2024 Annual Meeting.
 

Additional Surgery at Year 1

The new study used the all-payer Mariner database to identify patients aged 18-74 years with type 2 diabetes who underwent elective one- to three-level transforaminal lumbar interbody fusions (TLIFs) between January 2018 and October 2022. 

Patients were matched in a 3:1 ratio for age, sex, hypertension, obesity, smoking history, chronic kidney disease, osteoporosis, insulin use, and spinal fusion level, resulting in 447 patients with semaglutide use and 1334 with no semaglutide use. More than half (56%) were female, 62% used insulin, and 81% underwent single-level TLIF.

Total medical complications were higher in the semaglutide group, at 13.4%, compared with 7.7% in the no-semaglutide group (odds ratio [OR], 1.85). This was driven by higher rates of urinary tract infection (6.7% vs 2.5%) and acute kidney injury (6.3% vs 3.9%), two complications observed with semaglutide in other studies, Dr. Khalid said.

Total surgical complications, however, were lower in patients taking semaglutide, at 3.8% vs 5.2% in those who did not (OR, 0.73). 

Patients taking semaglutide vs those who were not using semaglutide had fewer wound healing complications (5 vs 31), hematoma (1 vs 9), surgical-site infections (12 vs 44), and cerebrospinal fluid leaks (2 vs 3).

Still, people taking semaglutide were nearly 12 times more likely to have an additional lumbar surgery at 1 year than did those who did not use the drug (27.3% vs 3.1%; OR, 11.79; 95% CI, 8.17-17.33).

Kaplan-Meier plots revealed a striking divergence of these populations when semaglutide exposure for more than or less than 9 months was examined (log-rank P < .0001).

Currently under review for publication, this study provides the first evidence on the impact of semaglutide on spine surgery, Dr. Khalid said. A second follow-up paper, also under review, looked only at patients with patients morbidly obesity without diabetes who had taken semaglutide for weight loss. 

“In nondiabetic, morbidly obese patients undergoing spine surgery, we see a similar trend,” Dr. Khalid said.
 

Sarcopenia the Cause?

The additional surgeries were primarily extensions of constructs, with additional surgery and fusion at more levels, Dr. Khalid noted. 

“The idea is that it could be the fact there is sarcopenia or muscle loss that’s taking place in conjunction with fat loss that’s causing that to happen,” Dr. Khalid said.

The mechanism remains speculative, but evidence from other areas examining frailty states has shown that those patients have weaker bones, sarcopenia, and worse outcomes with spine surgery, he noted. 

The investigators plan to use artificial intelligence to evaluate changes in body composition after semaglutide use in patients who underwent imaging prior to spine surgery or even before back pain occurred. Because these medications are uptitrated over time, follow-up studies will also look at whether this change takes place with a certain dose, Dr. Khalid added. 

On the basis of the current analysis of generic semaglutide alone, it’s not possible to say whether the use of other glucagon-like peptide 1 (GLP-1) receptor agonists will result in similar findings, but “the odds of a class effect are high,” Dr. Khalid said. 

Commenting on the findings, Walavan Sivakumar, MD, director of neurosurgery at Pacific Neuroscience Institute, Los Angeles, noted that the timing of surgery is already an issue for patients taking semaglutide and other GLP-1 receptor agonists following recent guidance from the American Society of Anesthesiologists that suggests stopping GLP-1 receptor agonists prior to elective surgery to reduce the risk for complications associated with anesthesia.

“It’s an incredibly topical point and seems to be something showing up on a daily basis for clinicians all throughout neurosurgery,” Dr. Sivakumar said. “It’s thought-provoking and a great first start.” 

Dr. Sivakumar also observed that frailty is a hot topic in all of neurosurgery. “That’s a major, major point that’s showing an impact on all surgical outcomes and it’s being heavily studied in the neurosurgical subsets right now. So that’s definitely a possible correlating factor.”

Dr. Khalid reported no financial relationships. Dr. Sivakumar reported serving as a consultant for Stryker. 
 

A version of this article appeared on Medscape.com.

CHICAGO — The diabetes/weight loss drug semaglutide is associated with a significantly greater risk for repeat operations in patients with diabetes who require lumbar surgery, a new study suggests.

The risk for additional surgeries was even higher among patients taking the popular weight loss and diabetes drug for longer periods of time.

Investigators say the study provides the first evidence on the impact of semaglutide on spine surgery. 

“The expectation was [that] we would see patients doing better after surgery, less wound complications, and other things, and in our diabetic patients we did not see that and saw increased odds of needing additional surgeries,” investigator Syed I. Khalid, MD, neurosurgery resident at University of Illinois Chicago, told this news organization.

The findings were presented on May 3 at the American Association of Neurological Surgeons (AANS) 2024 Annual Meeting.
 

Additional Surgery at Year 1

The new study used the all-payer Mariner database to identify patients aged 18-74 years with type 2 diabetes who underwent elective one- to three-level transforaminal lumbar interbody fusions (TLIFs) between January 2018 and October 2022. 

Patients were matched in a 3:1 ratio for age, sex, hypertension, obesity, smoking history, chronic kidney disease, osteoporosis, insulin use, and spinal fusion level, resulting in 447 patients with semaglutide use and 1334 with no semaglutide use. More than half (56%) were female, 62% used insulin, and 81% underwent single-level TLIF.

Total medical complications were higher in the semaglutide group, at 13.4%, compared with 7.7% in the no-semaglutide group (odds ratio [OR], 1.85). This was driven by higher rates of urinary tract infection (6.7% vs 2.5%) and acute kidney injury (6.3% vs 3.9%), two complications observed with semaglutide in other studies, Dr. Khalid said.

Total surgical complications, however, were lower in patients taking semaglutide, at 3.8% vs 5.2% in those who did not (OR, 0.73). 

Patients taking semaglutide vs those who were not using semaglutide had fewer wound healing complications (5 vs 31), hematoma (1 vs 9), surgical-site infections (12 vs 44), and cerebrospinal fluid leaks (2 vs 3).

Still, people taking semaglutide were nearly 12 times more likely to have an additional lumbar surgery at 1 year than did those who did not use the drug (27.3% vs 3.1%; OR, 11.79; 95% CI, 8.17-17.33).

Kaplan-Meier plots revealed a striking divergence of these populations when semaglutide exposure for more than or less than 9 months was examined (log-rank P < .0001).

Currently under review for publication, this study provides the first evidence on the impact of semaglutide on spine surgery, Dr. Khalid said. A second follow-up paper, also under review, looked only at patients with patients morbidly obesity without diabetes who had taken semaglutide for weight loss. 

“In nondiabetic, morbidly obese patients undergoing spine surgery, we see a similar trend,” Dr. Khalid said.
 

Sarcopenia the Cause?

The additional surgeries were primarily extensions of constructs, with additional surgery and fusion at more levels, Dr. Khalid noted. 

“The idea is that it could be the fact there is sarcopenia or muscle loss that’s taking place in conjunction with fat loss that’s causing that to happen,” Dr. Khalid said.

The mechanism remains speculative, but evidence from other areas examining frailty states has shown that those patients have weaker bones, sarcopenia, and worse outcomes with spine surgery, he noted. 

The investigators plan to use artificial intelligence to evaluate changes in body composition after semaglutide use in patients who underwent imaging prior to spine surgery or even before back pain occurred. Because these medications are uptitrated over time, follow-up studies will also look at whether this change takes place with a certain dose, Dr. Khalid added. 

On the basis of the current analysis of generic semaglutide alone, it’s not possible to say whether the use of other glucagon-like peptide 1 (GLP-1) receptor agonists will result in similar findings, but “the odds of a class effect are high,” Dr. Khalid said. 

Commenting on the findings, Walavan Sivakumar, MD, director of neurosurgery at Pacific Neuroscience Institute, Los Angeles, noted that the timing of surgery is already an issue for patients taking semaglutide and other GLP-1 receptor agonists following recent guidance from the American Society of Anesthesiologists that suggests stopping GLP-1 receptor agonists prior to elective surgery to reduce the risk for complications associated with anesthesia.

“It’s an incredibly topical point and seems to be something showing up on a daily basis for clinicians all throughout neurosurgery,” Dr. Sivakumar said. “It’s thought-provoking and a great first start.” 

Dr. Sivakumar also observed that frailty is a hot topic in all of neurosurgery. “That’s a major, major point that’s showing an impact on all surgical outcomes and it’s being heavily studied in the neurosurgical subsets right now. So that’s definitely a possible correlating factor.”

Dr. Khalid reported no financial relationships. Dr. Sivakumar reported serving as a consultant for Stryker. 
 

A version of this article appeared on Medscape.com.

CHICAGO — The diabetes/weight loss drug semaglutide is associated with a significantly greater risk for repeat operations in patients with diabetes who require lumbar surgery, a new study suggests.

The risk for additional surgeries was even higher among patients taking the popular weight loss and diabetes drug for longer periods of time.

Investigators say the study provides the first evidence on the impact of semaglutide on spine surgery. 

“The expectation was [that] we would see patients doing better after surgery, less wound complications, and other things, and in our diabetic patients we did not see that and saw increased odds of needing additional surgeries,” investigator Syed I. Khalid, MD, neurosurgery resident at University of Illinois Chicago, told this news organization.

The findings were presented on May 3 at the American Association of Neurological Surgeons (AANS) 2024 Annual Meeting.
 

Additional Surgery at Year 1

The new study used the all-payer Mariner database to identify patients aged 18-74 years with type 2 diabetes who underwent elective one- to three-level transforaminal lumbar interbody fusions (TLIFs) between January 2018 and October 2022. 

Patients were matched in a 3:1 ratio for age, sex, hypertension, obesity, smoking history, chronic kidney disease, osteoporosis, insulin use, and spinal fusion level, resulting in 447 patients with semaglutide use and 1334 with no semaglutide use. More than half (56%) were female, 62% used insulin, and 81% underwent single-level TLIF.

Total medical complications were higher in the semaglutide group, at 13.4%, compared with 7.7% in the no-semaglutide group (odds ratio [OR], 1.85). This was driven by higher rates of urinary tract infection (6.7% vs 2.5%) and acute kidney injury (6.3% vs 3.9%), two complications observed with semaglutide in other studies, Dr. Khalid said.

Total surgical complications, however, were lower in patients taking semaglutide, at 3.8% vs 5.2% in those who did not (OR, 0.73). 

Patients taking semaglutide vs those who were not using semaglutide had fewer wound healing complications (5 vs 31), hematoma (1 vs 9), surgical-site infections (12 vs 44), and cerebrospinal fluid leaks (2 vs 3).

Still, people taking semaglutide were nearly 12 times more likely to have an additional lumbar surgery at 1 year than did those who did not use the drug (27.3% vs 3.1%; OR, 11.79; 95% CI, 8.17-17.33).

Kaplan-Meier plots revealed a striking divergence of these populations when semaglutide exposure for more than or less than 9 months was examined (log-rank P < .0001).

Currently under review for publication, this study provides the first evidence on the impact of semaglutide on spine surgery, Dr. Khalid said. A second follow-up paper, also under review, looked only at patients with patients morbidly obesity without diabetes who had taken semaglutide for weight loss. 

“In nondiabetic, morbidly obese patients undergoing spine surgery, we see a similar trend,” Dr. Khalid said.
 

Sarcopenia the Cause?

The additional surgeries were primarily extensions of constructs, with additional surgery and fusion at more levels, Dr. Khalid noted. 

“The idea is that it could be the fact there is sarcopenia or muscle loss that’s taking place in conjunction with fat loss that’s causing that to happen,” Dr. Khalid said.

The mechanism remains speculative, but evidence from other areas examining frailty states has shown that those patients have weaker bones, sarcopenia, and worse outcomes with spine surgery, he noted. 

The investigators plan to use artificial intelligence to evaluate changes in body composition after semaglutide use in patients who underwent imaging prior to spine surgery or even before back pain occurred. Because these medications are uptitrated over time, follow-up studies will also look at whether this change takes place with a certain dose, Dr. Khalid added. 

On the basis of the current analysis of generic semaglutide alone, it’s not possible to say whether the use of other glucagon-like peptide 1 (GLP-1) receptor agonists will result in similar findings, but “the odds of a class effect are high,” Dr. Khalid said. 

Commenting on the findings, Walavan Sivakumar, MD, director of neurosurgery at Pacific Neuroscience Institute, Los Angeles, noted that the timing of surgery is already an issue for patients taking semaglutide and other GLP-1 receptor agonists following recent guidance from the American Society of Anesthesiologists that suggests stopping GLP-1 receptor agonists prior to elective surgery to reduce the risk for complications associated with anesthesia.

“It’s an incredibly topical point and seems to be something showing up on a daily basis for clinicians all throughout neurosurgery,” Dr. Sivakumar said. “It’s thought-provoking and a great first start.” 

Dr. Sivakumar also observed that frailty is a hot topic in all of neurosurgery. “That’s a major, major point that’s showing an impact on all surgical outcomes and it’s being heavily studied in the neurosurgical subsets right now. So that’s definitely a possible correlating factor.”

Dr. Khalid reported no financial relationships. Dr. Sivakumar reported serving as a consultant for Stryker. 
 

A version of this article appeared on Medscape.com.

Sherrie Palm, a patient advocate in Mukwonago, Wisconsin, learned in her 30s that she needed to educate herself about her own health. So when she discovered a walnut-sized lump coming out of her vagina in her mid-50s, she was stunned when her primary care provider (PCP) told her it was pelvic organ prolapse (POP), where one or more organs descend into the vaginal cavity.

“I was shocked,” Ms. Palm said. After searching online and discovering how prevalent POP was, her shock turned to anger. “I was blown away that it could be this common and I’d never heard of it,” she said. “I knew within 2 weeks that I had to do something to change the status quo.”

Ms. Palm eventually founded the nonprofit Association for Pelvic Organ Prolapse Support, or APOPS, complete with a forum where women can learn about POP and support one another. She said awareness has improved substantially since her diagnosis in 2007, but “we have a long way to go” because POP and vaginal health in general are so stigmatized.

Her website notes that about half of women with incontinence do not seek help, largely because of stigma. “The status quo is that PCPs do not POP screen,” she said. ObGyns may screen but often “because the patient has asked to be screened, they say it’s not that bad, come back and see me in a year, and do your Kegels,” Ms. Palm said.

Doctors who diagnose POP agree that the issue is often off PCPs’ radar.

“Primary care doctors are really in a time crunch, so this is one of the things that may not get addressed,” Jill Rabin, MD, vice chair of education and development in obstetrics and gynecology at Northwell Health in New York, said. Dr. Rabin is also head of urogynecology at Long Island Jewish Medical Center.

Ann Nwabuebo, PT, DPT, owner and founder of Body Connect Physical Therapy in Bethesda, Maryland, said social media has been shifting the attitude that pelvic health is a taboo subject. “It’s empowering people to seek care if they’re not finding physicians who are helping.”

But social media is also a double-edged sword, said Jenny LaCross, PT, DPT, PhD, a physical therapist at MOVE PT in Monroe, Michigan, and a postdoctoral research fellow with Michigan Medicine’s Pelvic Floor Research Group. “Pelvic health in general is talked about a lot more, but there’s also a lot more misinformation,” she said.

Part of that misinformation is the idea that pelvic prolapse is solely about weakness in the pelvic floor when it can also result from a widening of natural openings within the pelvis, Dr. LaCross said. She pointed to the two definitions of pelvic organ prolapse by the International Urogynecologic Consultation and the International Continence Society, both of which have been updated in recent years.

“This is why this is challenging for primary care providers,” Dr. LaCross said. “Even urogynecologists who are the specialists that treat prolapse and incontinence have changed how they assess it and the terminology and criteria that they use.”

What hasn’t changed is the substantial negative impact POP can have on quality of life. “This is the second most common reason that women enter nursing homes,” primarily because of urinary incontinence, Dr. Rabin said. “It’s very debilitating, but a lot of it is preventable and a lot is treatable.”

Dr. Rabin estimated that three out of every five women older than 60 and one or two out of every five women younger than 60 experience POP. Prevalence studies vary widely, from nearly a quarter of women to more than half, and racial and ethnic disparities in diagnosis further complicate the statistics.

PCPs therefore have an important role to play in screening for POP. The evidence shows that “patients want their providers to bring this up,” Dr. LaCross said. “They want to talk about it, but they want the provider to ask the questions first.”
 

Causes, Risk Factors, and Symptoms

Many causes contribute to POP, with gravity, aging, childbirth, and menopause at the top of the list.

“As people get older, their pelvic muscles and connective tissue get weaker, and the nerves don’t function as well,” Dr. Rabin said. Meanwhile, the body is losing estrogen, which affects how well the muscles contract and how easily the connective tissue can tear, she said.

With menopause, when baseline estrogen is lower, the tissue integrity is not as supportive as it should be and women are going to be at an increased risk of prolapse, Dr. Nwabuebo said.

POP has a range of risk factors:

• Increasing age, as muscle mass decreases and connective tissue hardens.
• Menopause.
• Vaginal delivery with complications, such as long second-stage labor, instrument-assisted delivery, multiple vaginal lacerations, and improperly repaired episiotomy.
• Multiple vaginal deliveries.
• Birthing large babies.
• Family history of pelvic organ prolapse (genetics can play a role in POP risk).
• Previous pelvic/abdominal surgery, including cesarean delivery and hysterectomy.
• Smoking (largely because of associated coughing).
• Chronic lung conditions that cause a lot of coughing.
• Chronic constipation or irritable bowel syndrome.
• Some types of high-impact activity, such as jogging or marathon running.
• Early menopause, for younger women.
• Repetitive heavy lifting in daily activities, such as occupational lifting (though not necessarily weight lifting as an exercise).
• Higher body mass index.
• Connective tissue disorders, such as joint hypermobility syndrome or Ehlers-Danlos syndrome.

Roger Dmochowski, MD, professor of urology and surgery at Vanderbilt University Medical Center, groups POP symptoms into two groups: anatomic and functional ones. A common anatomic symptom is bulging. “They’ll describe sitting on a ball, feeling like their bladder or something’s falling out, feeling a pressure or a heaviness,” Dr. Dmochowski said.

Functional symptoms can include vaginal dryness, vaginal irritation, painful intercourse, contact of the vaginal tissues with underclothes, and associated urinary symptoms, such as stress incontinence, urge incontinence, and incomplete emptying of the bladder. Dr. Dmochowski noted that women who report urinary incontinence may be at risk for being prescribed a medication without the necessary referral to a specialist for a full gynecologic evaluation.

Two other groups of functional symptoms include bowel-related disorders – primarily fecal incontinence and ongoing constipation – and pelvic pain or discomfort.

There can also be asymptomatic cases. “A lot of women have what we call silent prolapse,” Dr. Dmochowski said. That is, “they have some degree of loss of support to the bladder, vagina, or uterus, but they’re not symptomatic.” These women may be particularly good candidates for pelvic health physical therapy.
 

Screening and Diagnosis

Because many postmenopausal women stop seeing their ob.gyn, it’s often up to their primary care physician to determine whether their patients are experiencing POP symptoms.

“Women sometimes don’t bring this up with their doctor because they think there’s not enough time, or they’ll be laughed at, or their friends told them this is normal,” Dr. Rabin said. But primary care providers are really in a unique position to be able to ask the key symptom questions.

Dr. Rabin recommends a couple of questions to cover all the bases: “Do you leak urine when you cough or sneeze or on the way to the bathroom? Do you notice a bulge coming out of the vagina, or are you bothered by pelvic pressure?”

Dr. Dmochowski offered a single question that can open the conversation to more questions: “Are you bothered by any urinary or bowel or vaginal issues that we should talk about?” He also suggests asking how bothersome the symptoms are, which can help in directing treatment or prevention options. A physical exam can reveal signs of POP as well.

Diagnosis involves a detailed history, a comprehensive physical exam, and assessment with the Pelvic Organ Prolapse Quantification (POP-Q) tool. A urogynecologist can diagnose the type of POP – such as cystocele, rectocele, enterocele, uterine prolapse, or vaginal vault prolapse – and its grade (0-4).
 

Treatment: Physical Therapy, Pessary, and Surgery

No medications can treat prolapse, though some can treat downstream effects, such as hormonal vaginal creams for vaginal dryness and irritation, and medications for urinary incontinence. However, two mistakes PCPs can make are sending someone straight to surgery or prescribing them medication for symptoms without referring them for a diagnostic evaluation, Dr. Rabin said. “You have to have a diagnosis first to know what type of prolapse is there,” she said.

Because there can be long waiting lists for a urogynecologist or urologist, PCPs should also refer their patients to a pelvic health physical therapist (PT) who can help patients begin addressing the symptoms while they await a specialist who can diagnose them.

Though PT is often thought of as preventive, it’s also a conservative first-line intervention for prolapse, Dr. Nwabuebo said. Strong evidence shows pelvic floor muscle training from pelvic health PT can reduce symptoms of prolapse and reduce the severity by one grade in those with a grade 1 or 2 prolapse. Stage 3 is trickier, where PT may or may not be able to shift the symptom presentation, Dr. Nwabeubo said, and stage 4 is usually a surgical candidate.

“If you have a grade 4 prolapse, or the tissues are really visible outside the body, physical therapy and pelvic floor muscle training is not going to elevate that tissue back up into your body, but it can sometimes help with symptoms,” Dr. LaCross said.

The PT conducts a thorough pelvic muscle assessment, discusses lifestyle, and may teach breathing and bracing strategies for lifting, for example.

“A lot of what we’re talking about with pelvic floor therapy is lifestyle modifications,” Dr. Nwabuebo said. “If I have a patient with a history of chronic constipation, it doesn’t matter how much we do pelvic floor exercises; if we don’t manage the constipation issues by addressing their nutrition, then straining when using the bathroom will keep putting pressure on the pelvic floor.”

PTs can also recommend appropriate vaginal weights and dilators to help with pelvic floor strengthening and teach patients how to use them properly.

Even if women ultimately opt for surgery, PT prior to surgery can be beneficial. Dr. Rabin cited three reasons she recommends first-line PT: It may elevate the bladder enough to reduce stress incontinence and thicken the pelvic muscles, it can improve the effectiveness of a pessary or surgery if the woman chooses one of those options, and it can quiet bladder contractions, potentially obviating the need for pharmacologic treatment for overactive bladder.

The next nonsurgical option is a pessary, a device that fits into the vagina to provide support to the tissues displaced by prolapse. There’s a wide range of pessary types: some are short-term, worn only daily, or disposable, while others can be worn longer. Some women can self-insert and remove the pessary, and others may need a clinician to do so. Dr. Dmochowski recommends patients try a pessary to see if it benefits them. About a third of women will find them comfortable enough to wear regularly, but others will feel more sensitive to the pessary’s presence, he said.

One of the newest, most innovative pessary options for women is Gynethotics, which received Food and Drug Administration (FDA) clearance in March, as the first 3D-printed, customizable pessary capable of nearly 10 million configurations based on a person’s body.

Nearly all stage 4 prolapses and most of stage 3 prolapses can be addressed only through transvaginal or transabdominal surgery.

“We tell patients, if you can get 10 years out of your operation, you’re lucky,” Dr. Dmochowski said. A major reason for the short-lived durability is the poor quality of the tissue that needs to be pulled together. Serious complications resulting from use of polypropylene mesh during prolapse surgery led the FDA to halt sales of the devices and recommend discontinuing their use. However, one type of vaginal mesh is still considered safe to use in sacral colpopexy surgery.

Three things can shorten the durability of the surgery, Dr. Dmochowski said: heavy lifting, particularly anything over 30 pounds; chronic coughing, such as in those with chronic lung conditions; and chronic constipation.

Ms. Palm tried a pessary for her grade 3 prolapse with cystocele, rectocele, and enterocele but didn’t feel she had the time to use it regularly, so she opted for surgery. After a week on the couch recovering, she took it easy for another 12 weeks. Since then, she’s dedicated much of her time to educating and supporting women with POP and combating stigma associated with it. The APOPS website that she started has become a valuable resource for PCPs to send patients to, and the forum includes more 27,000 women from around the world.

“We encourage women to share what they’re experiencing. Tell your family, tell your friends, tell the people you work with about it,” Ms. Palm said. But many still feel uncomfortable speaking up, making PCPs’ role even more important.

*This story was updated on May 14, 2024.

Sherrie Palm, a patient advocate in Mukwonago, Wisconsin, learned in her 30s that she needed to educate herself about her own health. So when she discovered a walnut-sized lump coming out of her vagina in her mid-50s, she was stunned when her primary care provider (PCP) told her it was pelvic organ prolapse (POP), where one or more organs descend into the vaginal cavity.

“I was shocked,” Ms. Palm said. After searching online and discovering how prevalent POP was, her shock turned to anger. “I was blown away that it could be this common and I’d never heard of it,” she said. “I knew within 2 weeks that I had to do something to change the status quo.”

Ms. Palm eventually founded the nonprofit Association for Pelvic Organ Prolapse Support, or APOPS, complete with a forum where women can learn about POP and support one another. She said awareness has improved substantially since her diagnosis in 2007, but “we have a long way to go” because POP and vaginal health in general are so stigmatized.

Her website notes that about half of women with incontinence do not seek help, largely because of stigma. “The status quo is that PCPs do not POP screen,” she said. ObGyns may screen but often “because the patient has asked to be screened, they say it’s not that bad, come back and see me in a year, and do your Kegels,” Ms. Palm said.

Doctors who diagnose POP agree that the issue is often off PCPs’ radar.

“Primary care doctors are really in a time crunch, so this is one of the things that may not get addressed,” Jill Rabin, MD, vice chair of education and development in obstetrics and gynecology at Northwell Health in New York, said. Dr. Rabin is also head of urogynecology at Long Island Jewish Medical Center.

Ann Nwabuebo, PT, DPT, owner and founder of Body Connect Physical Therapy in Bethesda, Maryland, said social media has been shifting the attitude that pelvic health is a taboo subject. “It’s empowering people to seek care if they’re not finding physicians who are helping.”

But social media is also a double-edged sword, said Jenny LaCross, PT, DPT, PhD, a physical therapist at MOVE PT in Monroe, Michigan, and a postdoctoral research fellow with Michigan Medicine’s Pelvic Floor Research Group. “Pelvic health in general is talked about a lot more, but there’s also a lot more misinformation,” she said.

Part of that misinformation is the idea that pelvic prolapse is solely about weakness in the pelvic floor when it can also result from a widening of natural openings within the pelvis, Dr. LaCross said. She pointed to the two definitions of pelvic organ prolapse by the International Urogynecologic Consultation and the International Continence Society, both of which have been updated in recent years.

“This is why this is challenging for primary care providers,” Dr. LaCross said. “Even urogynecologists who are the specialists that treat prolapse and incontinence have changed how they assess it and the terminology and criteria that they use.”

What hasn’t changed is the substantial negative impact POP can have on quality of life. “This is the second most common reason that women enter nursing homes,” primarily because of urinary incontinence, Dr. Rabin said. “It’s very debilitating, but a lot of it is preventable and a lot is treatable.”

Dr. Rabin estimated that three out of every five women older than 60 and one or two out of every five women younger than 60 experience POP. Prevalence studies vary widely, from nearly a quarter of women to more than half, and racial and ethnic disparities in diagnosis further complicate the statistics.

PCPs therefore have an important role to play in screening for POP. The evidence shows that “patients want their providers to bring this up,” Dr. LaCross said. “They want to talk about it, but they want the provider to ask the questions first.”
 

Causes, Risk Factors, and Symptoms

Many causes contribute to POP, with gravity, aging, childbirth, and menopause at the top of the list.

“As people get older, their pelvic muscles and connective tissue get weaker, and the nerves don’t function as well,” Dr. Rabin said. Meanwhile, the body is losing estrogen, which affects how well the muscles contract and how easily the connective tissue can tear, she said.

With menopause, when baseline estrogen is lower, the tissue integrity is not as supportive as it should be and women are going to be at an increased risk of prolapse, Dr. Nwabuebo said.

POP has a range of risk factors:

• Increasing age, as muscle mass decreases and connective tissue hardens.
• Menopause.
• Vaginal delivery with complications, such as long second-stage labor, instrument-assisted delivery, multiple vaginal lacerations, and improperly repaired episiotomy.
• Multiple vaginal deliveries.
• Birthing large babies.
• Family history of pelvic organ prolapse (genetics can play a role in POP risk).
• Previous pelvic/abdominal surgery, including cesarean delivery and hysterectomy.
• Smoking (largely because of associated coughing).
• Chronic lung conditions that cause a lot of coughing.
• Chronic constipation or irritable bowel syndrome.
• Some types of high-impact activity, such as jogging or marathon running.
• Early menopause, for younger women.
• Repetitive heavy lifting in daily activities, such as occupational lifting (though not necessarily weight lifting as an exercise).
• Higher body mass index.
• Connective tissue disorders, such as joint hypermobility syndrome or Ehlers-Danlos syndrome.

Roger Dmochowski, MD, professor of urology and surgery at Vanderbilt University Medical Center, groups POP symptoms into two groups: anatomic and functional ones. A common anatomic symptom is bulging. “They’ll describe sitting on a ball, feeling like their bladder or something’s falling out, feeling a pressure or a heaviness,” Dr. Dmochowski said.

Functional symptoms can include vaginal dryness, vaginal irritation, painful intercourse, contact of the vaginal tissues with underclothes, and associated urinary symptoms, such as stress incontinence, urge incontinence, and incomplete emptying of the bladder. Dr. Dmochowski noted that women who report urinary incontinence may be at risk for being prescribed a medication without the necessary referral to a specialist for a full gynecologic evaluation.

Two other groups of functional symptoms include bowel-related disorders – primarily fecal incontinence and ongoing constipation – and pelvic pain or discomfort.

There can also be asymptomatic cases. “A lot of women have what we call silent prolapse,” Dr. Dmochowski said. That is, “they have some degree of loss of support to the bladder, vagina, or uterus, but they’re not symptomatic.” These women may be particularly good candidates for pelvic health physical therapy.
 

Screening and Diagnosis

Because many postmenopausal women stop seeing their ob.gyn, it’s often up to their primary care physician to determine whether their patients are experiencing POP symptoms.

“Women sometimes don’t bring this up with their doctor because they think there’s not enough time, or they’ll be laughed at, or their friends told them this is normal,” Dr. Rabin said. But primary care providers are really in a unique position to be able to ask the key symptom questions.

Dr. Rabin recommends a couple of questions to cover all the bases: “Do you leak urine when you cough or sneeze or on the way to the bathroom? Do you notice a bulge coming out of the vagina, or are you bothered by pelvic pressure?”

Dr. Dmochowski offered a single question that can open the conversation to more questions: “Are you bothered by any urinary or bowel or vaginal issues that we should talk about?” He also suggests asking how bothersome the symptoms are, which can help in directing treatment or prevention options. A physical exam can reveal signs of POP as well.

Diagnosis involves a detailed history, a comprehensive physical exam, and assessment with the Pelvic Organ Prolapse Quantification (POP-Q) tool. A urogynecologist can diagnose the type of POP – such as cystocele, rectocele, enterocele, uterine prolapse, or vaginal vault prolapse – and its grade (0-4).
 

Treatment: Physical Therapy, Pessary, and Surgery

No medications can treat prolapse, though some can treat downstream effects, such as hormonal vaginal creams for vaginal dryness and irritation, and medications for urinary incontinence. However, two mistakes PCPs can make are sending someone straight to surgery or prescribing them medication for symptoms without referring them for a diagnostic evaluation, Dr. Rabin said. “You have to have a diagnosis first to know what type of prolapse is there,” she said.

Because there can be long waiting lists for a urogynecologist or urologist, PCPs should also refer their patients to a pelvic health physical therapist (PT) who can help patients begin addressing the symptoms while they await a specialist who can diagnose them.

Though PT is often thought of as preventive, it’s also a conservative first-line intervention for prolapse, Dr. Nwabuebo said. Strong evidence shows pelvic floor muscle training from pelvic health PT can reduce symptoms of prolapse and reduce the severity by one grade in those with a grade 1 or 2 prolapse. Stage 3 is trickier, where PT may or may not be able to shift the symptom presentation, Dr. Nwabeubo said, and stage 4 is usually a surgical candidate.

“If you have a grade 4 prolapse, or the tissues are really visible outside the body, physical therapy and pelvic floor muscle training is not going to elevate that tissue back up into your body, but it can sometimes help with symptoms,” Dr. LaCross said.

The PT conducts a thorough pelvic muscle assessment, discusses lifestyle, and may teach breathing and bracing strategies for lifting, for example.

“A lot of what we’re talking about with pelvic floor therapy is lifestyle modifications,” Dr. Nwabuebo said. “If I have a patient with a history of chronic constipation, it doesn’t matter how much we do pelvic floor exercises; if we don’t manage the constipation issues by addressing their nutrition, then straining when using the bathroom will keep putting pressure on the pelvic floor.”

PTs can also recommend appropriate vaginal weights and dilators to help with pelvic floor strengthening and teach patients how to use them properly.

Even if women ultimately opt for surgery, PT prior to surgery can be beneficial. Dr. Rabin cited three reasons she recommends first-line PT: It may elevate the bladder enough to reduce stress incontinence and thicken the pelvic muscles, it can improve the effectiveness of a pessary or surgery if the woman chooses one of those options, and it can quiet bladder contractions, potentially obviating the need for pharmacologic treatment for overactive bladder.

The next nonsurgical option is a pessary, a device that fits into the vagina to provide support to the tissues displaced by prolapse. There’s a wide range of pessary types: some are short-term, worn only daily, or disposable, while others can be worn longer. Some women can self-insert and remove the pessary, and others may need a clinician to do so. Dr. Dmochowski recommends patients try a pessary to see if it benefits them. About a third of women will find them comfortable enough to wear regularly, but others will feel more sensitive to the pessary’s presence, he said.

One of the newest, most innovative pessary options for women is Gynethotics, which received Food and Drug Administration (FDA) clearance in March, as the first 3D-printed, customizable pessary capable of nearly 10 million configurations based on a person’s body.

Nearly all stage 4 prolapses and most of stage 3 prolapses can be addressed only through transvaginal or transabdominal surgery.

“We tell patients, if you can get 10 years out of your operation, you’re lucky,” Dr. Dmochowski said. A major reason for the short-lived durability is the poor quality of the tissue that needs to be pulled together. Serious complications resulting from use of polypropylene mesh during prolapse surgery led the FDA to halt sales of the devices and recommend discontinuing their use. However, one type of vaginal mesh is still considered safe to use in sacral colpopexy surgery.

Three things can shorten the durability of the surgery, Dr. Dmochowski said: heavy lifting, particularly anything over 30 pounds; chronic coughing, such as in those with chronic lung conditions; and chronic constipation.

Ms. Palm tried a pessary for her grade 3 prolapse with cystocele, rectocele, and enterocele but didn’t feel she had the time to use it regularly, so she opted for surgery. After a week on the couch recovering, she took it easy for another 12 weeks. Since then, she’s dedicated much of her time to educating and supporting women with POP and combating stigma associated with it. The APOPS website that she started has become a valuable resource for PCPs to send patients to, and the forum includes more 27,000 women from around the world.

“We encourage women to share what they’re experiencing. Tell your family, tell your friends, tell the people you work with about it,” Ms. Palm said. But many still feel uncomfortable speaking up, making PCPs’ role even more important.

*This story was updated on May 14, 2024.

Sherrie Palm, a patient advocate in Mukwonago, Wisconsin, learned in her 30s that she needed to educate herself about her own health. So when she discovered a walnut-sized lump coming out of her vagina in her mid-50s, she was stunned when her primary care provider (PCP) told her it was pelvic organ prolapse (POP), where one or more organs descend into the vaginal cavity.

“I was shocked,” Ms. Palm said. After searching online and discovering how prevalent POP was, her shock turned to anger. “I was blown away that it could be this common and I’d never heard of it,” she said. “I knew within 2 weeks that I had to do something to change the status quo.”

Ms. Palm eventually founded the nonprofit Association for Pelvic Organ Prolapse Support, or APOPS, complete with a forum where women can learn about POP and support one another. She said awareness has improved substantially since her diagnosis in 2007, but “we have a long way to go” because POP and vaginal health in general are so stigmatized.

Her website notes that about half of women with incontinence do not seek help, largely because of stigma. “The status quo is that PCPs do not POP screen,” she said. ObGyns may screen but often “because the patient has asked to be screened, they say it’s not that bad, come back and see me in a year, and do your Kegels,” Ms. Palm said.

Doctors who diagnose POP agree that the issue is often off PCPs’ radar.

“Primary care doctors are really in a time crunch, so this is one of the things that may not get addressed,” Jill Rabin, MD, vice chair of education and development in obstetrics and gynecology at Northwell Health in New York, said. Dr. Rabin is also head of urogynecology at Long Island Jewish Medical Center.

Ann Nwabuebo, PT, DPT, owner and founder of Body Connect Physical Therapy in Bethesda, Maryland, said social media has been shifting the attitude that pelvic health is a taboo subject. “It’s empowering people to seek care if they’re not finding physicians who are helping.”

But social media is also a double-edged sword, said Jenny LaCross, PT, DPT, PhD, a physical therapist at MOVE PT in Monroe, Michigan, and a postdoctoral research fellow with Michigan Medicine’s Pelvic Floor Research Group. “Pelvic health in general is talked about a lot more, but there’s also a lot more misinformation,” she said.

Part of that misinformation is the idea that pelvic prolapse is solely about weakness in the pelvic floor when it can also result from a widening of natural openings within the pelvis, Dr. LaCross said. She pointed to the two definitions of pelvic organ prolapse by the International Urogynecologic Consultation and the International Continence Society, both of which have been updated in recent years.

“This is why this is challenging for primary care providers,” Dr. LaCross said. “Even urogynecologists who are the specialists that treat prolapse and incontinence have changed how they assess it and the terminology and criteria that they use.”

What hasn’t changed is the substantial negative impact POP can have on quality of life. “This is the second most common reason that women enter nursing homes,” primarily because of urinary incontinence, Dr. Rabin said. “It’s very debilitating, but a lot of it is preventable and a lot is treatable.”

Dr. Rabin estimated that three out of every five women older than 60 and one or two out of every five women younger than 60 experience POP. Prevalence studies vary widely, from nearly a quarter of women to more than half, and racial and ethnic disparities in diagnosis further complicate the statistics.

PCPs therefore have an important role to play in screening for POP. The evidence shows that “patients want their providers to bring this up,” Dr. LaCross said. “They want to talk about it, but they want the provider to ask the questions first.”
 

Causes, Risk Factors, and Symptoms

Many causes contribute to POP, with gravity, aging, childbirth, and menopause at the top of the list.

“As people get older, their pelvic muscles and connective tissue get weaker, and the nerves don’t function as well,” Dr. Rabin said. Meanwhile, the body is losing estrogen, which affects how well the muscles contract and how easily the connective tissue can tear, she said.

With menopause, when baseline estrogen is lower, the tissue integrity is not as supportive as it should be and women are going to be at an increased risk of prolapse, Dr. Nwabuebo said.

POP has a range of risk factors:

• Increasing age, as muscle mass decreases and connective tissue hardens.
• Menopause.
• Vaginal delivery with complications, such as long second-stage labor, instrument-assisted delivery, multiple vaginal lacerations, and improperly repaired episiotomy.
• Multiple vaginal deliveries.
• Birthing large babies.
• Family history of pelvic organ prolapse (genetics can play a role in POP risk).
• Previous pelvic/abdominal surgery, including cesarean delivery and hysterectomy.
• Smoking (largely because of associated coughing).
• Chronic lung conditions that cause a lot of coughing.
• Chronic constipation or irritable bowel syndrome.
• Some types of high-impact activity, such as jogging or marathon running.
• Early menopause, for younger women.
• Repetitive heavy lifting in daily activities, such as occupational lifting (though not necessarily weight lifting as an exercise).
• Higher body mass index.
• Connective tissue disorders, such as joint hypermobility syndrome or Ehlers-Danlos syndrome.

Roger Dmochowski, MD, professor of urology and surgery at Vanderbilt University Medical Center, groups POP symptoms into two groups: anatomic and functional ones. A common anatomic symptom is bulging. “They’ll describe sitting on a ball, feeling like their bladder or something’s falling out, feeling a pressure or a heaviness,” Dr. Dmochowski said.

Functional symptoms can include vaginal dryness, vaginal irritation, painful intercourse, contact of the vaginal tissues with underclothes, and associated urinary symptoms, such as stress incontinence, urge incontinence, and incomplete emptying of the bladder. Dr. Dmochowski noted that women who report urinary incontinence may be at risk for being prescribed a medication without the necessary referral to a specialist for a full gynecologic evaluation.

Two other groups of functional symptoms include bowel-related disorders – primarily fecal incontinence and ongoing constipation – and pelvic pain or discomfort.

There can also be asymptomatic cases. “A lot of women have what we call silent prolapse,” Dr. Dmochowski said. That is, “they have some degree of loss of support to the bladder, vagina, or uterus, but they’re not symptomatic.” These women may be particularly good candidates for pelvic health physical therapy.
 

Screening and Diagnosis

Because many postmenopausal women stop seeing their ob.gyn, it’s often up to their primary care physician to determine whether their patients are experiencing POP symptoms.

“Women sometimes don’t bring this up with their doctor because they think there’s not enough time, or they’ll be laughed at, or their friends told them this is normal,” Dr. Rabin said. But primary care providers are really in a unique position to be able to ask the key symptom questions.

Dr. Rabin recommends a couple of questions to cover all the bases: “Do you leak urine when you cough or sneeze or on the way to the bathroom? Do you notice a bulge coming out of the vagina, or are you bothered by pelvic pressure?”

Dr. Dmochowski offered a single question that can open the conversation to more questions: “Are you bothered by any urinary or bowel or vaginal issues that we should talk about?” He also suggests asking how bothersome the symptoms are, which can help in directing treatment or prevention options. A physical exam can reveal signs of POP as well.

Diagnosis involves a detailed history, a comprehensive physical exam, and assessment with the Pelvic Organ Prolapse Quantification (POP-Q) tool. A urogynecologist can diagnose the type of POP – such as cystocele, rectocele, enterocele, uterine prolapse, or vaginal vault prolapse – and its grade (0-4).
 

Treatment: Physical Therapy, Pessary, and Surgery

No medications can treat prolapse, though some can treat downstream effects, such as hormonal vaginal creams for vaginal dryness and irritation, and medications for urinary incontinence. However, two mistakes PCPs can make are sending someone straight to surgery or prescribing them medication for symptoms without referring them for a diagnostic evaluation, Dr. Rabin said. “You have to have a diagnosis first to know what type of prolapse is there,” she said.

Because there can be long waiting lists for a urogynecologist or urologist, PCPs should also refer their patients to a pelvic health physical therapist (PT) who can help patients begin addressing the symptoms while they await a specialist who can diagnose them.

Though PT is often thought of as preventive, it’s also a conservative first-line intervention for prolapse, Dr. Nwabuebo said. Strong evidence shows pelvic floor muscle training from pelvic health PT can reduce symptoms of prolapse and reduce the severity by one grade in those with a grade 1 or 2 prolapse. Stage 3 is trickier, where PT may or may not be able to shift the symptom presentation, Dr. Nwabeubo said, and stage 4 is usually a surgical candidate.

“If you have a grade 4 prolapse, or the tissues are really visible outside the body, physical therapy and pelvic floor muscle training is not going to elevate that tissue back up into your body, but it can sometimes help with symptoms,” Dr. LaCross said.

The PT conducts a thorough pelvic muscle assessment, discusses lifestyle, and may teach breathing and bracing strategies for lifting, for example.

“A lot of what we’re talking about with pelvic floor therapy is lifestyle modifications,” Dr. Nwabuebo said. “If I have a patient with a history of chronic constipation, it doesn’t matter how much we do pelvic floor exercises; if we don’t manage the constipation issues by addressing their nutrition, then straining when using the bathroom will keep putting pressure on the pelvic floor.”

PTs can also recommend appropriate vaginal weights and dilators to help with pelvic floor strengthening and teach patients how to use them properly.

Even if women ultimately opt for surgery, PT prior to surgery can be beneficial. Dr. Rabin cited three reasons she recommends first-line PT: It may elevate the bladder enough to reduce stress incontinence and thicken the pelvic muscles, it can improve the effectiveness of a pessary or surgery if the woman chooses one of those options, and it can quiet bladder contractions, potentially obviating the need for pharmacologic treatment for overactive bladder.

The next nonsurgical option is a pessary, a device that fits into the vagina to provide support to the tissues displaced by prolapse. There’s a wide range of pessary types: some are short-term, worn only daily, or disposable, while others can be worn longer. Some women can self-insert and remove the pessary, and others may need a clinician to do so. Dr. Dmochowski recommends patients try a pessary to see if it benefits them. About a third of women will find them comfortable enough to wear regularly, but others will feel more sensitive to the pessary’s presence, he said.

One of the newest, most innovative pessary options for women is Gynethotics, which received Food and Drug Administration (FDA) clearance in March, as the first 3D-printed, customizable pessary capable of nearly 10 million configurations based on a person’s body.

Nearly all stage 4 prolapses and most of stage 3 prolapses can be addressed only through transvaginal or transabdominal surgery.

“We tell patients, if you can get 10 years out of your operation, you’re lucky,” Dr. Dmochowski said. A major reason for the short-lived durability is the poor quality of the tissue that needs to be pulled together. Serious complications resulting from use of polypropylene mesh during prolapse surgery led the FDA to halt sales of the devices and recommend discontinuing their use. However, one type of vaginal mesh is still considered safe to use in sacral colpopexy surgery.

Three things can shorten the durability of the surgery, Dr. Dmochowski said: heavy lifting, particularly anything over 30 pounds; chronic coughing, such as in those with chronic lung conditions; and chronic constipation.

Ms. Palm tried a pessary for her grade 3 prolapse with cystocele, rectocele, and enterocele but didn’t feel she had the time to use it regularly, so she opted for surgery. After a week on the couch recovering, she took it easy for another 12 weeks. Since then, she’s dedicated much of her time to educating and supporting women with POP and combating stigma associated with it. The APOPS website that she started has become a valuable resource for PCPs to send patients to, and the forum includes more 27,000 women from around the world.

“We encourage women to share what they’re experiencing. Tell your family, tell your friends, tell the people you work with about it,” Ms. Palm said. But many still feel uncomfortable speaking up, making PCPs’ role even more important.

*This story was updated on May 14, 2024.

As three federal agencies investigate how private equity ownership and consolidation of healthcare organizations affects patient care and costs, physicians are giving them an earful.

“Before I retired, I could already see the damage private equity was doing to hospitals and medical practices. Well-regarded physician groups were being bought and the respected doctors and staff forced out to squeeze out profit for the buyers. Hospital-based physicians were being hit especially hard,” wrote Rhonda Wright, MD, of Brookhaven, Georgia. 

“Now, the rot is setting in for emergency rooms. One in four ERs is now (under-)staffed by private equity firms. This is leading to longer wait times, deterioration in patient care, and higher bills,” Dr. Wright continued. “Private equity takeover of medicine must be stopped. All such deals should be strictly regulated and should be heavily scrutinized, if not barred altogether. Our health depends upon it!”

The federal government is accepting public comments like Dr. Wright’s through June 5 and has even set up a website (healthycompetition.gov) to make it easier to file complaints against health organizations possibly violating antitrust laws.

The US Department of Justice’s Antitrust Division, the Federal Trade Commission (FTC), and the Department of Health and Human Services want to hear from physicians and the public about how private equity firms’ investments in healthcare entities, such as hospitals, nursing homes, or specialty service providers, affect patients and healthcare workers. The investigation will also evaluate how market pricing, competition, and referral patterns change when practices and hospitals are acquired by health systems or insurers.

Maintaining competition in the provider and payer markets benefits healthcare workers through higher pay, while patients can access quality care at lower prices, the joint request for information said. However, consolidation and mergers — potentially driven by private equity’s entry into the market — can diminish these benefits.

Investigating private equity and consolidation in medicine is part of the Biden Administration’s focus on lowering medical and prescription drug costs and strengthening competition in healthcare. The FTC’s vote last week to ban noncompete agreements, which business groups have vowed to challenge in court, falls under the same initiative.

Alexandra Nicole Thran, MD, FACEP, president of the Vermont Chapter of the American College of Emergency Physicians, said that the private equity business model is problematic because it ties physicians’ wages to patient satisfaction and the number of patients they see per hour. 

A Connecticut primary care physician expressed similar sentiments. “Physicians are being forced into a system where corporations provide financial incentives and punitive policies to direct healthcare decisions towards a profitable aim,” said Eric Schwaber, MD. 

While a majority of comments criticized the role of private equity and consolidation, some reflected a more positive view. 

“Private equity helps make healthcare more efficient and effective. It brings needed operational and managerial expertise to allow for better patient care,” said Reenie Abraham, MD, an associate professor in the Department of Internal Medicine at University of Texas Southwestern Medical Center, Dallas. The University of Texas is facing a lawsuit involving the liability status of its physicians who work for a private equity-backed hospital partly owned by the university.

Several public comments point to the increasing market influence UnitedHealth Group (UHG) and other payers have obtained through recent acquisitions. Retired emergency room physician Scott Davis, MD, said that the “astronomical” rate of burnout among providers has been exacerbated by “the economic takeover of the healthcare system by…United Healthcare [and] private equity groups who put profits over anything else.”  

The healthcare conglomerate employs approximately 10% of active US physicians, including many through its subsidiary, Optum Health, which provides primary, urgent, and surgical care. UHG has also invested heavily in acquiring physician practices to advance its value-based care model.

“If a publicly traded private insurance or private equity company is interested in their short-term quarterly profits or stock price, there is little interest in the…effective management of chronic disease, other than that which fulfills a ‘value-based’ metric,” wrote Kenneth Dolkart, MD, FACP, clinical assistant professor at the Dartmouth Geisel School of Medicine in Hanover, New Hampshire. 

Sarah Ealy, a revenue cycle professional, commented that payers like UHG have outsized bargaining power when negotiating rates with providers. “In many states, United Healthcare and its subsidiaries pay a lower reimbursement rate than state Medicaid plans — these rates are nearly 50% of the breakeven per-visit rate that practices need to keep the lights on.”

Another comment ties the recent cyberattack on UHG-owned Change Healthcare to private equity ownership and “healthcare behemoths buying up practices and data.”

“The ramrodding of consolidation and private oversight with little to no barriers to foreign intrusions…is a testament to how ill prepared [the] US market is to private equity healthcare takeovers,” said SW Dermatology Practice LLC. 

The agencies request comments from all health market participants, including physicians, nurses, employers, administrators, and patients.

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

As three federal agencies investigate how private equity ownership and consolidation of healthcare organizations affects patient care and costs, physicians are giving them an earful.

“Before I retired, I could already see the damage private equity was doing to hospitals and medical practices. Well-regarded physician groups were being bought and the respected doctors and staff forced out to squeeze out profit for the buyers. Hospital-based physicians were being hit especially hard,” wrote Rhonda Wright, MD, of Brookhaven, Georgia. 

“Now, the rot is setting in for emergency rooms. One in four ERs is now (under-)staffed by private equity firms. This is leading to longer wait times, deterioration in patient care, and higher bills,” Dr. Wright continued. “Private equity takeover of medicine must be stopped. All such deals should be strictly regulated and should be heavily scrutinized, if not barred altogether. Our health depends upon it!”

The federal government is accepting public comments like Dr. Wright’s through June 5 and has even set up a website (healthycompetition.gov) to make it easier to file complaints against health organizations possibly violating antitrust laws.

The US Department of Justice’s Antitrust Division, the Federal Trade Commission (FTC), and the Department of Health and Human Services want to hear from physicians and the public about how private equity firms’ investments in healthcare entities, such as hospitals, nursing homes, or specialty service providers, affect patients and healthcare workers. The investigation will also evaluate how market pricing, competition, and referral patterns change when practices and hospitals are acquired by health systems or insurers.

Maintaining competition in the provider and payer markets benefits healthcare workers through higher pay, while patients can access quality care at lower prices, the joint request for information said. However, consolidation and mergers — potentially driven by private equity’s entry into the market — can diminish these benefits.

Investigating private equity and consolidation in medicine is part of the Biden Administration’s focus on lowering medical and prescription drug costs and strengthening competition in healthcare. The FTC’s vote last week to ban noncompete agreements, which business groups have vowed to challenge in court, falls under the same initiative.

Alexandra Nicole Thran, MD, FACEP, president of the Vermont Chapter of the American College of Emergency Physicians, said that the private equity business model is problematic because it ties physicians’ wages to patient satisfaction and the number of patients they see per hour. 

A Connecticut primary care physician expressed similar sentiments. “Physicians are being forced into a system where corporations provide financial incentives and punitive policies to direct healthcare decisions towards a profitable aim,” said Eric Schwaber, MD. 

While a majority of comments criticized the role of private equity and consolidation, some reflected a more positive view. 

“Private equity helps make healthcare more efficient and effective. It brings needed operational and managerial expertise to allow for better patient care,” said Reenie Abraham, MD, an associate professor in the Department of Internal Medicine at University of Texas Southwestern Medical Center, Dallas. The University of Texas is facing a lawsuit involving the liability status of its physicians who work for a private equity-backed hospital partly owned by the university.

Several public comments point to the increasing market influence UnitedHealth Group (UHG) and other payers have obtained through recent acquisitions. Retired emergency room physician Scott Davis, MD, said that the “astronomical” rate of burnout among providers has been exacerbated by “the economic takeover of the healthcare system by…United Healthcare [and] private equity groups who put profits over anything else.”  

The healthcare conglomerate employs approximately 10% of active US physicians, including many through its subsidiary, Optum Health, which provides primary, urgent, and surgical care. UHG has also invested heavily in acquiring physician practices to advance its value-based care model.

“If a publicly traded private insurance or private equity company is interested in their short-term quarterly profits or stock price, there is little interest in the…effective management of chronic disease, other than that which fulfills a ‘value-based’ metric,” wrote Kenneth Dolkart, MD, FACP, clinical assistant professor at the Dartmouth Geisel School of Medicine in Hanover, New Hampshire. 

Sarah Ealy, a revenue cycle professional, commented that payers like UHG have outsized bargaining power when negotiating rates with providers. “In many states, United Healthcare and its subsidiaries pay a lower reimbursement rate than state Medicaid plans — these rates are nearly 50% of the breakeven per-visit rate that practices need to keep the lights on.”

Another comment ties the recent cyberattack on UHG-owned Change Healthcare to private equity ownership and “healthcare behemoths buying up practices and data.”

“The ramrodding of consolidation and private oversight with little to no barriers to foreign intrusions…is a testament to how ill prepared [the] US market is to private equity healthcare takeovers,” said SW Dermatology Practice LLC. 

The agencies request comments from all health market participants, including physicians, nurses, employers, administrators, and patients.

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

As three federal agencies investigate how private equity ownership and consolidation of healthcare organizations affects patient care and costs, physicians are giving them an earful.

“Before I retired, I could already see the damage private equity was doing to hospitals and medical practices. Well-regarded physician groups were being bought and the respected doctors and staff forced out to squeeze out profit for the buyers. Hospital-based physicians were being hit especially hard,” wrote Rhonda Wright, MD, of Brookhaven, Georgia. 

“Now, the rot is setting in for emergency rooms. One in four ERs is now (under-)staffed by private equity firms. This is leading to longer wait times, deterioration in patient care, and higher bills,” Dr. Wright continued. “Private equity takeover of medicine must be stopped. All such deals should be strictly regulated and should be heavily scrutinized, if not barred altogether. Our health depends upon it!”

The federal government is accepting public comments like Dr. Wright’s through June 5 and has even set up a website (healthycompetition.gov) to make it easier to file complaints against health organizations possibly violating antitrust laws.

The US Department of Justice’s Antitrust Division, the Federal Trade Commission (FTC), and the Department of Health and Human Services want to hear from physicians and the public about how private equity firms’ investments in healthcare entities, such as hospitals, nursing homes, or specialty service providers, affect patients and healthcare workers. The investigation will also evaluate how market pricing, competition, and referral patterns change when practices and hospitals are acquired by health systems or insurers.

Maintaining competition in the provider and payer markets benefits healthcare workers through higher pay, while patients can access quality care at lower prices, the joint request for information said. However, consolidation and mergers — potentially driven by private equity’s entry into the market — can diminish these benefits.

Investigating private equity and consolidation in medicine is part of the Biden Administration’s focus on lowering medical and prescription drug costs and strengthening competition in healthcare. The FTC’s vote last week to ban noncompete agreements, which business groups have vowed to challenge in court, falls under the same initiative.

Alexandra Nicole Thran, MD, FACEP, president of the Vermont Chapter of the American College of Emergency Physicians, said that the private equity business model is problematic because it ties physicians’ wages to patient satisfaction and the number of patients they see per hour. 

A Connecticut primary care physician expressed similar sentiments. “Physicians are being forced into a system where corporations provide financial incentives and punitive policies to direct healthcare decisions towards a profitable aim,” said Eric Schwaber, MD. 

While a majority of comments criticized the role of private equity and consolidation, some reflected a more positive view. 

“Private equity helps make healthcare more efficient and effective. It brings needed operational and managerial expertise to allow for better patient care,” said Reenie Abraham, MD, an associate professor in the Department of Internal Medicine at University of Texas Southwestern Medical Center, Dallas. The University of Texas is facing a lawsuit involving the liability status of its physicians who work for a private equity-backed hospital partly owned by the university.

Several public comments point to the increasing market influence UnitedHealth Group (UHG) and other payers have obtained through recent acquisitions. Retired emergency room physician Scott Davis, MD, said that the “astronomical” rate of burnout among providers has been exacerbated by “the economic takeover of the healthcare system by…United Healthcare [and] private equity groups who put profits over anything else.”  

The healthcare conglomerate employs approximately 10% of active US physicians, including many through its subsidiary, Optum Health, which provides primary, urgent, and surgical care. UHG has also invested heavily in acquiring physician practices to advance its value-based care model.

“If a publicly traded private insurance or private equity company is interested in their short-term quarterly profits or stock price, there is little interest in the…effective management of chronic disease, other than that which fulfills a ‘value-based’ metric,” wrote Kenneth Dolkart, MD, FACP, clinical assistant professor at the Dartmouth Geisel School of Medicine in Hanover, New Hampshire. 

Sarah Ealy, a revenue cycle professional, commented that payers like UHG have outsized bargaining power when negotiating rates with providers. “In many states, United Healthcare and its subsidiaries pay a lower reimbursement rate than state Medicaid plans — these rates are nearly 50% of the breakeven per-visit rate that practices need to keep the lights on.”

Another comment ties the recent cyberattack on UHG-owned Change Healthcare to private equity ownership and “healthcare behemoths buying up practices and data.”

“The ramrodding of consolidation and private oversight with little to no barriers to foreign intrusions…is a testament to how ill prepared [the] US market is to private equity healthcare takeovers,” said SW Dermatology Practice LLC. 

The agencies request comments from all health market participants, including physicians, nurses, employers, administrators, and patients.

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

A recent study links waist size and a higher risk for asthma attack. After adjustments, the likelihood of asthma attacks was 1.06 times higher for every 5-cm increase in waist circumference in adults with asthma.

BMI Earlier Tied to Asthma

Previous research supports a link between increased body mass index (BMI) and asthma, but the association between abdominal obesity and asthma attacks has not been well studied.

The researchers in the current study reviewed data from the National Health and Nutrition Examination Survey for 5530 adults with asthma in the United States. Adults in the study were divided into groups based on whether they did or did not experience asthma attacks.

The median age of the study population was 43 years, the median waist circumference was 98.9 cm, and the median BMI was 28.50.
 

More Waist Inches = Asthma Attacks

Overall, patients who reported asthma attacks had a significantly higher waist circumference than those without asthma attacks (median, 102.6 cm vs 97.3 cm, P < .001).

The association between increased waist circumference and increased odds of asthma attack was significant across non-adjusted, minimally adjusted, and fully adjusted models (odds ratios, 1.7, 1.06, and 1.06, respectively). In fact, each 5-cm increase in waist circumference was associated with a 1.06 times higher likelihood of an asthma attack after full adjustment for BMI-defined obesity, age, gender, race/ethnicity, education, poverty income ratio, smoking status, and metabolic syndrome.

The relationship between increased likelihood of asthma attacks and increased waist circumference persisted in subgroup analyses based on gender, age, and smoking status.
 

Importance of Waist Size

“Our study underscores the critical role of waist circumference measurements in the routine health evaluations of individuals diagnosed with asthma, highlighting its inclusion as an essential aspect of comprehensive health assessments,” the researchers wrote.

Limited to Data Available

The study findings were limited by several factors including the use of existing database questions to evaluate asthma attacks, a lack of data on the specificity of triggers of asthma exacerbations, and an inability to distinguish the severity of asthma attacks.

The study was published online in BMC Public Health. The lead author was Xiang Liu, MD, of Qingdao Municipal Hospital, Qingdao, China.

The study received no outside funding. The researchers had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.

A recent study links waist size and a higher risk for asthma attack. After adjustments, the likelihood of asthma attacks was 1.06 times higher for every 5-cm increase in waist circumference in adults with asthma.

BMI Earlier Tied to Asthma

Previous research supports a link between increased body mass index (BMI) and asthma, but the association between abdominal obesity and asthma attacks has not been well studied.

The researchers in the current study reviewed data from the National Health and Nutrition Examination Survey for 5530 adults with asthma in the United States. Adults in the study were divided into groups based on whether they did or did not experience asthma attacks.

The median age of the study population was 43 years, the median waist circumference was 98.9 cm, and the median BMI was 28.50.
 

More Waist Inches = Asthma Attacks

Overall, patients who reported asthma attacks had a significantly higher waist circumference than those without asthma attacks (median, 102.6 cm vs 97.3 cm, P < .001).

The association between increased waist circumference and increased odds of asthma attack was significant across non-adjusted, minimally adjusted, and fully adjusted models (odds ratios, 1.7, 1.06, and 1.06, respectively). In fact, each 5-cm increase in waist circumference was associated with a 1.06 times higher likelihood of an asthma attack after full adjustment for BMI-defined obesity, age, gender, race/ethnicity, education, poverty income ratio, smoking status, and metabolic syndrome.

The relationship between increased likelihood of asthma attacks and increased waist circumference persisted in subgroup analyses based on gender, age, and smoking status.
 

Importance of Waist Size

“Our study underscores the critical role of waist circumference measurements in the routine health evaluations of individuals diagnosed with asthma, highlighting its inclusion as an essential aspect of comprehensive health assessments,” the researchers wrote.

Limited to Data Available

The study findings were limited by several factors including the use of existing database questions to evaluate asthma attacks, a lack of data on the specificity of triggers of asthma exacerbations, and an inability to distinguish the severity of asthma attacks.

The study was published online in BMC Public Health. The lead author was Xiang Liu, MD, of Qingdao Municipal Hospital, Qingdao, China.

The study received no outside funding. The researchers had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.

A recent study links waist size and a higher risk for asthma attack. After adjustments, the likelihood of asthma attacks was 1.06 times higher for every 5-cm increase in waist circumference in adults with asthma.

BMI Earlier Tied to Asthma

Previous research supports a link between increased body mass index (BMI) and asthma, but the association between abdominal obesity and asthma attacks has not been well studied.

The researchers in the current study reviewed data from the National Health and Nutrition Examination Survey for 5530 adults with asthma in the United States. Adults in the study were divided into groups based on whether they did or did not experience asthma attacks.

The median age of the study population was 43 years, the median waist circumference was 98.9 cm, and the median BMI was 28.50.
 

More Waist Inches = Asthma Attacks

Overall, patients who reported asthma attacks had a significantly higher waist circumference than those without asthma attacks (median, 102.6 cm vs 97.3 cm, P < .001).

The association between increased waist circumference and increased odds of asthma attack was significant across non-adjusted, minimally adjusted, and fully adjusted models (odds ratios, 1.7, 1.06, and 1.06, respectively). In fact, each 5-cm increase in waist circumference was associated with a 1.06 times higher likelihood of an asthma attack after full adjustment for BMI-defined obesity, age, gender, race/ethnicity, education, poverty income ratio, smoking status, and metabolic syndrome.

The relationship between increased likelihood of asthma attacks and increased waist circumference persisted in subgroup analyses based on gender, age, and smoking status.
 

Importance of Waist Size

“Our study underscores the critical role of waist circumference measurements in the routine health evaluations of individuals diagnosed with asthma, highlighting its inclusion as an essential aspect of comprehensive health assessments,” the researchers wrote.

Limited to Data Available

The study findings were limited by several factors including the use of existing database questions to evaluate asthma attacks, a lack of data on the specificity of triggers of asthma exacerbations, and an inability to distinguish the severity of asthma attacks.

The study was published online in BMC Public Health. The lead author was Xiang Liu, MD, of Qingdao Municipal Hospital, Qingdao, China.

The study received no outside funding. The researchers had no financial conflicts to disclose.

A version of this article appeared on Medscape.com.

Pharmaceutical giant Eli Lilly recently announced that its newly approved weight loss medication Zepbound — a glucagon-like peptide 1 receptor agonist (GLP-1 RA) akin to Mounjaro, Ozempic, and Wegovy — will be prescribed by independent telehealth providers on a platform managed by the company itself. The drug can be subsequently shipped direct to consumer (DTC), allowing delivery straight to patients’ homes. 

This arrangement raises serious concerns about an inherent conflict of interest, as we previously discussed. What happens when a pharmaceutical company influences access to remote providers who prescribe the very medications it manufactures? Will these remote providers truly put the patient’s interest first when debating their safety and appropriate use? Whom will patients consult if they have concerns after initiating the medication?

Without new guardrails, the potential for misleading messaging to result in dangerous prescribing patterns looms large. The United States is one of only two countries to allow DTC advertising of prescription drugs, and the explosion in demand for GLP-1 RAs is partly attributable to this model (Oh, oh, Ozempic, anyone?). Americans spent over $78 billion on weight loss goods and services in 2019; time-intensive approaches such as diet and exercise are understandably difficult, and the public has always looked for a magic cure. Although GLP-1 RAs are promising, they may present a path to disaster without proper supervision.

LillyDirect, which in addition to Zepbound offers migraine medications and other products in the company’s catalogue, primarily aims to increase access to medication and reduce costs of the drugs for consumers. The stated mission is noble: By cutting out the middlemen of traditional pharmacies and benefit managers, administrative costs drop. LillyDirect goes a step further by reducing the need for patients to visit their regular family doctor to receive these medications.

On the surface, this design appears promising. Wait times for doctor’s appointments will fall. Patients can order drugs from the comfort of their home. Everyone benefits. Or do they? 

Although easier access and reduced cost may be an apparent win for patients, DTC arrangements complicate the ethics of prescriptions and patient follow-up. This model reminds us of the roots of the opioid crisis, where powerful advertising and relationships between prescribers and drugmakers led to great harm. Providers often faced a conflict of interest when prescribing dangerous drugs to patients who requested them. We must learn from these mistakes to ensure there is critical oversight into the independence of prescribers used by LillyDirect and other DTC platforms.

Adding to these parallels, once a patient begins a GLP-1 medication such as Zepbound, stopping treatment will probably lead to regaining lost weight, serving as negative reinforcement. Hence, patients may decide never to discontinue these medications.

Obtaining what amounts to a lifelong prescription from a telehealth provider who may never follow a patient sets a dangerous precedent that will be difficult to unravel once begun. Recent challenges in access to medications such as Zepbound have been complicated by supply chain and manufacturing issues, leading to potential interruptions in patient access, ultimately affecting compliance. The rapid increase in online providers indicates competition for distribution channels has sharply increased and poses a threat to Lilly’s DTC site. 

Furthermore, the lack of a regular physician to monitor patients introduces uncertainty in safety and continuity of care. These are important tenets in protecting patients, especially patients who are not diabetic and desire a quick fix. We have already seen a huge, arguably unrestrained, rise in prescriptions of GLP-1 RAs for weight loss — up to a 352% increase in 2023.

These drugs have shown great promise and are generally safe when used in the right patient, but important contraindications exist — namely, serious gastrointestinal side effects and low blood glucose in nondiabetic persons — that an astute physician must consider. Patients desiring these medications often must undergo comprehensive laboratory testing and cardiac evaluation, both before initiation and during regular follow-up, to check for comorbidities.

The American College of Physicians cautioned against such prescribing practices in a recent position statement, emphasizing that the lack of an established care provider could adversely affect patients. We note that the potential harms of DTC sales would concentrate in economically and racially underserved communities, where obesity, lack of insurance, and low health literacy are more common. 

But the DTC genie is out of the pill bottle, and as such platforms become more common, patients will inherently take more ownership over their medical care. Remote providers will of course not be following these patients and evaluating for side effects. As a result, we in medical practice must be abreast of new downsides of these medications if and when they arise. 

Every clinician must be aware of the medications a patient is taking, even those that they did not prescribe. They should educate their patients about drug-drug interactions and side effects and order lab tests to monitor for side effects. 

Independent physicians abide by an underlying oath: First, do no harm. They serve as a trusted check on industry and a valuable long-term partner for patients. Where are the guardrails to protect patients and ensure that pharmaceutical companies are not essentially pushing prescriptions for their own products? Will traditional healthcare providers be effectively relegated to a bystander role in Lilly’s transactional approach to medication distribution? Unlike other commercial goods, pharmacologics have great nuance; not every approved medication is meant for every patient.

A version of this article appeared on Medscape.com.

Pharmaceutical giant Eli Lilly recently announced that its newly approved weight loss medication Zepbound — a glucagon-like peptide 1 receptor agonist (GLP-1 RA) akin to Mounjaro, Ozempic, and Wegovy — will be prescribed by independent telehealth providers on a platform managed by the company itself. The drug can be subsequently shipped direct to consumer (DTC), allowing delivery straight to patients’ homes. 

This arrangement raises serious concerns about an inherent conflict of interest, as we previously discussed. What happens when a pharmaceutical company influences access to remote providers who prescribe the very medications it manufactures? Will these remote providers truly put the patient’s interest first when debating their safety and appropriate use? Whom will patients consult if they have concerns after initiating the medication?

Without new guardrails, the potential for misleading messaging to result in dangerous prescribing patterns looms large. The United States is one of only two countries to allow DTC advertising of prescription drugs, and the explosion in demand for GLP-1 RAs is partly attributable to this model (Oh, oh, Ozempic, anyone?). Americans spent over $78 billion on weight loss goods and services in 2019; time-intensive approaches such as diet and exercise are understandably difficult, and the public has always looked for a magic cure. Although GLP-1 RAs are promising, they may present a path to disaster without proper supervision.

LillyDirect, which in addition to Zepbound offers migraine medications and other products in the company’s catalogue, primarily aims to increase access to medication and reduce costs of the drugs for consumers. The stated mission is noble: By cutting out the middlemen of traditional pharmacies and benefit managers, administrative costs drop. LillyDirect goes a step further by reducing the need for patients to visit their regular family doctor to receive these medications.

On the surface, this design appears promising. Wait times for doctor’s appointments will fall. Patients can order drugs from the comfort of their home. Everyone benefits. Or do they? 

Although easier access and reduced cost may be an apparent win for patients, DTC arrangements complicate the ethics of prescriptions and patient follow-up. This model reminds us of the roots of the opioid crisis, where powerful advertising and relationships between prescribers and drugmakers led to great harm. Providers often faced a conflict of interest when prescribing dangerous drugs to patients who requested them. We must learn from these mistakes to ensure there is critical oversight into the independence of prescribers used by LillyDirect and other DTC platforms.

Adding to these parallels, once a patient begins a GLP-1 medication such as Zepbound, stopping treatment will probably lead to regaining lost weight, serving as negative reinforcement. Hence, patients may decide never to discontinue these medications.

Obtaining what amounts to a lifelong prescription from a telehealth provider who may never follow a patient sets a dangerous precedent that will be difficult to unravel once begun. Recent challenges in access to medications such as Zepbound have been complicated by supply chain and manufacturing issues, leading to potential interruptions in patient access, ultimately affecting compliance. The rapid increase in online providers indicates competition for distribution channels has sharply increased and poses a threat to Lilly’s DTC site. 

Furthermore, the lack of a regular physician to monitor patients introduces uncertainty in safety and continuity of care. These are important tenets in protecting patients, especially patients who are not diabetic and desire a quick fix. We have already seen a huge, arguably unrestrained, rise in prescriptions of GLP-1 RAs for weight loss — up to a 352% increase in 2023.

These drugs have shown great promise and are generally safe when used in the right patient, but important contraindications exist — namely, serious gastrointestinal side effects and low blood glucose in nondiabetic persons — that an astute physician must consider. Patients desiring these medications often must undergo comprehensive laboratory testing and cardiac evaluation, both before initiation and during regular follow-up, to check for comorbidities.

The American College of Physicians cautioned against such prescribing practices in a recent position statement, emphasizing that the lack of an established care provider could adversely affect patients. We note that the potential harms of DTC sales would concentrate in economically and racially underserved communities, where obesity, lack of insurance, and low health literacy are more common. 

But the DTC genie is out of the pill bottle, and as such platforms become more common, patients will inherently take more ownership over their medical care. Remote providers will of course not be following these patients and evaluating for side effects. As a result, we in medical practice must be abreast of new downsides of these medications if and when they arise. 

Every clinician must be aware of the medications a patient is taking, even those that they did not prescribe. They should educate their patients about drug-drug interactions and side effects and order lab tests to monitor for side effects. 

Independent physicians abide by an underlying oath: First, do no harm. They serve as a trusted check on industry and a valuable long-term partner for patients. Where are the guardrails to protect patients and ensure that pharmaceutical companies are not essentially pushing prescriptions for their own products? Will traditional healthcare providers be effectively relegated to a bystander role in Lilly’s transactional approach to medication distribution? Unlike other commercial goods, pharmacologics have great nuance; not every approved medication is meant for every patient.

A version of this article appeared on Medscape.com.

Pharmaceutical giant Eli Lilly recently announced that its newly approved weight loss medication Zepbound — a glucagon-like peptide 1 receptor agonist (GLP-1 RA) akin to Mounjaro, Ozempic, and Wegovy — will be prescribed by independent telehealth providers on a platform managed by the company itself. The drug can be subsequently shipped direct to consumer (DTC), allowing delivery straight to patients’ homes. 

This arrangement raises serious concerns about an inherent conflict of interest, as we previously discussed. What happens when a pharmaceutical company influences access to remote providers who prescribe the very medications it manufactures? Will these remote providers truly put the patient’s interest first when debating their safety and appropriate use? Whom will patients consult if they have concerns after initiating the medication?

Without new guardrails, the potential for misleading messaging to result in dangerous prescribing patterns looms large. The United States is one of only two countries to allow DTC advertising of prescription drugs, and the explosion in demand for GLP-1 RAs is partly attributable to this model (Oh, oh, Ozempic, anyone?). Americans spent over $78 billion on weight loss goods and services in 2019; time-intensive approaches such as diet and exercise are understandably difficult, and the public has always looked for a magic cure. Although GLP-1 RAs are promising, they may present a path to disaster without proper supervision.

LillyDirect, which in addition to Zepbound offers migraine medications and other products in the company’s catalogue, primarily aims to increase access to medication and reduce costs of the drugs for consumers. The stated mission is noble: By cutting out the middlemen of traditional pharmacies and benefit managers, administrative costs drop. LillyDirect goes a step further by reducing the need for patients to visit their regular family doctor to receive these medications.

On the surface, this design appears promising. Wait times for doctor’s appointments will fall. Patients can order drugs from the comfort of their home. Everyone benefits. Or do they? 

Although easier access and reduced cost may be an apparent win for patients, DTC arrangements complicate the ethics of prescriptions and patient follow-up. This model reminds us of the roots of the opioid crisis, where powerful advertising and relationships between prescribers and drugmakers led to great harm. Providers often faced a conflict of interest when prescribing dangerous drugs to patients who requested them. We must learn from these mistakes to ensure there is critical oversight into the independence of prescribers used by LillyDirect and other DTC platforms.

Adding to these parallels, once a patient begins a GLP-1 medication such as Zepbound, stopping treatment will probably lead to regaining lost weight, serving as negative reinforcement. Hence, patients may decide never to discontinue these medications.

Obtaining what amounts to a lifelong prescription from a telehealth provider who may never follow a patient sets a dangerous precedent that will be difficult to unravel once begun. Recent challenges in access to medications such as Zepbound have been complicated by supply chain and manufacturing issues, leading to potential interruptions in patient access, ultimately affecting compliance. The rapid increase in online providers indicates competition for distribution channels has sharply increased and poses a threat to Lilly’s DTC site. 

Furthermore, the lack of a regular physician to monitor patients introduces uncertainty in safety and continuity of care. These are important tenets in protecting patients, especially patients who are not diabetic and desire a quick fix. We have already seen a huge, arguably unrestrained, rise in prescriptions of GLP-1 RAs for weight loss — up to a 352% increase in 2023.

These drugs have shown great promise and are generally safe when used in the right patient, but important contraindications exist — namely, serious gastrointestinal side effects and low blood glucose in nondiabetic persons — that an astute physician must consider. Patients desiring these medications often must undergo comprehensive laboratory testing and cardiac evaluation, both before initiation and during regular follow-up, to check for comorbidities.

The American College of Physicians cautioned against such prescribing practices in a recent position statement, emphasizing that the lack of an established care provider could adversely affect patients. We note that the potential harms of DTC sales would concentrate in economically and racially underserved communities, where obesity, lack of insurance, and low health literacy are more common. 

But the DTC genie is out of the pill bottle, and as such platforms become more common, patients will inherently take more ownership over their medical care. Remote providers will of course not be following these patients and evaluating for side effects. As a result, we in medical practice must be abreast of new downsides of these medications if and when they arise. 

Every clinician must be aware of the medications a patient is taking, even those that they did not prescribe. They should educate their patients about drug-drug interactions and side effects and order lab tests to monitor for side effects. 

Independent physicians abide by an underlying oath: First, do no harm. They serve as a trusted check on industry and a valuable long-term partner for patients. Where are the guardrails to protect patients and ensure that pharmaceutical companies are not essentially pushing prescriptions for their own products? Will traditional healthcare providers be effectively relegated to a bystander role in Lilly’s transactional approach to medication distribution? Unlike other commercial goods, pharmacologics have great nuance; not every approved medication is meant for every patient.

A version of this article appeared on Medscape.com.

People with diabetes don’t have higher gastric volumes than those without diabetes after following standard preoperative fasting instructions, suggested a study from a team of anesthesiologist researchers.

However, an endocrinologist faulted the study in part because the participants appeared to be healthier than typical populations with type 1 and type 2 diabetes. Moreover, the issue is now further complicated by the widespread use of glucagon-like peptide-1 (GLP-1) receptor agonists for the treatment of both type 2 diabetes and weight loss. These drugs, which were introduced after the study’s enrollment period, work in part by delaying gastric emptying.

The new data come from a prospective study of 84 people with diabetes (85% with type 2) and 96 without diabetes, all with a body mass index (BMI) < 40, who were undergoing elective surgery. A gastric ultrasound was used to assess their gastric contents after they had followed the standard preoperative fasting guidelines of stopping solids 8 hours prior to the procedure and clearing liquids 2 hours prior.

There was no significant difference between the two groups in gastric volume (0.81 mL/kg with diabetes vs 0.87 mL/kg without) or in the proportion with “full stomach,” as designated by the American Society of Anesthesiologists (ASA) guidelines (any solid content or > 1.5 mL/kg of clear fluid), which was seen in 13 with diabetes (15.5%) and 11 (11.5%) without.

Published in Anesthesiology, the findings offer reassurance that different fasting instructions generally aren’t needed for people with diabetes in order to minimize the risk for perioperative pulmonary aspiration, lead author Anahi Perlas, MD, professor of anesthesiology and pain medicine at the University of Toronto, told this news organization.

“We never change practice completely based on a single study, but I think in general, based on our findings, that most diabetic patients aren’t any different from nondiabetics when it comes to their gastric content after fasting, and our standard fasting instructions seem to be just as effective in ensuring an empty stomach.”

But, she added, “If someone has symptoms of gastroparesis or when in doubt, we can always do a gastric ultrasound exam at the bedside and see whether the stomach is full or empty ... it’s very quick, and it’s not difficult to do.”
 

Expert Identifies Noteworthy Study Limitations

In an accompanying editorial, Mark A. Warner, MD, professor of anesthesiology at the Mayo Clinic in Rochester, Minnesota, said the findings “will be very helpful to anesthesiologists,” although he noted that the exclusion of people with a BMI > 40 is a limitation.

However, Michael Horowitz, MBBS, PhD, FRACP, director of the Endocrine and Metabolic Unit at the Royal Adelaide Hospital and professor of medicine at Adelaide Medical School in Adelaide, Australia, disputed the study’s conclusions. He noted that the sample was small, and the participants had an average A1c of 7.2%. Fewer than half had microvascular or neuropathic complications. Thus, they were healthier than the general population with diabetes.

“They’ve picked the wrong group of diabetics,” said Dr. Horowitz, who specializes in gastrointestinal complications of diabetes. “This is not a group where you would expect a very high prevalence of delayed emptying.”

Gastric emptying of solids and liquids varies widely even among healthy people and more so in those with type 2 diabetes. About a third of those with above-target A1c levels have gastroparesis, while those more in the target range tend to have accelerated emptying, he explained.

And regarding the use of gastric ultrasound for those who are symptomatic, Dr. Horowitz said, “The relationship of symptoms such as nausea, vomiting, fullness, whatever it may be, with the rate of gastric emptying is weak at best. The association is not simply cause and effect.”
 

Are the Fasting Guidelines Flawed, Regardless of Diabetes Status?

Dr. Horowitz also faulted the ASA’s 2017 guidance revision for allowing clear liquids to be consumed up to 2 hours in advance of anesthesia because it doesn’t distinguish between liquids with and without calories.

“Whether you have diabetes or not, if you are allowed to have a sugar drink up to 2 hours before your operation, the majority of people empty at about 4 kcal/min, so they will still have some of that drink in their stomach,” he said. “If you want an empty stomach, the ASA guidelines are wrong.”

That explains why the study found relatively high rates of “full stomach” in both groups, 15.5% of those with diabetes and 11.5% of those without, he said.
 

The GLP-1 Agonist Factor

Although the study didn’t address GLP-1 receptor agonist use, Dr. Warner did in his accompanying editorial, noting that the drugs’ rapid expansion “will likely change how we use perioperative fasting guidelines. With these medications delaying gastric emptying times, we now have another risk factor for pulmonary aspiration to consider when applying fasting guidelines. The inconsistent impact of GLP-1 agonists on gastric emptying, ranging from little to significant, makes it difficult for anesthesiologists to gauge whether or not patients taking GLP-1 agonists are likely to have preoperative gastric liquid or solid contents that could cause subsequent damage if regurgitated.”

Gastric ultrasound can be helpful in this situation, Dr. Warner wrote. In addition, he endorsed the 2023 ASA guidance, which calls for withholding daily-dosed GLP-1 agonists on the day of the surgery and the weekly formulations for a week. And if gastrointestinal symptoms are present, delay elective procedures.

But Dr. Horowitz said those recommendations are likely insufficient as well, pointing to data suggesting that daily liraglutide can delay gastric emptying for up to 16 weeks in about a third of patients. Such studies haven’t been conducted by the manufacturers, particularly on the once-weekly formulations, and the ensuing risk for aspiration isn’t known.

“The slowing occurs in much lower doses than are used for glucose lowering,” Dr. Horowitz said. “It is very likely that plasma levels will need to be extremely low to avoid gastric slowing. The current guidelines fail to appreciate this. So, to withhold the short-acting drugs for 1 day is probably wrong. And to stop long-acting drugs for 1 week is almost certainly wrong too.”

But as for what should be done, he said, “I don’t actually know what you do about it. And no one does because there are no data available to answer the question.”

The study received funding from the Physicians’ Services Incorporated Foundation and the Canadian Society of Anesthesiologists. Dr. Perlas received support for nonclinical time through a merit award from the Department of Anesthesiology and Pain Medicine, University of Toronto, and the Department of Anesthesia and Pain Management, Toronto Western Hospital, University Health Network. She is an executive editor of the journal Regional Anesthesia and Pain Medicine and does consulting work for FujiFilm SonoSite. Dr. Horowitz had no relevant disclosures.
 

A version of this article appeared on Medscape.com.

People with diabetes don’t have higher gastric volumes than those without diabetes after following standard preoperative fasting instructions, suggested a study from a team of anesthesiologist researchers.

However, an endocrinologist faulted the study in part because the participants appeared to be healthier than typical populations with type 1 and type 2 diabetes. Moreover, the issue is now further complicated by the widespread use of glucagon-like peptide-1 (GLP-1) receptor agonists for the treatment of both type 2 diabetes and weight loss. These drugs, which were introduced after the study’s enrollment period, work in part by delaying gastric emptying.

The new data come from a prospective study of 84 people with diabetes (85% with type 2) and 96 without diabetes, all with a body mass index (BMI) < 40, who were undergoing elective surgery. A gastric ultrasound was used to assess their gastric contents after they had followed the standard preoperative fasting guidelines of stopping solids 8 hours prior to the procedure and clearing liquids 2 hours prior.

There was no significant difference between the two groups in gastric volume (0.81 mL/kg with diabetes vs 0.87 mL/kg without) or in the proportion with “full stomach,” as designated by the American Society of Anesthesiologists (ASA) guidelines (any solid content or > 1.5 mL/kg of clear fluid), which was seen in 13 with diabetes (15.5%) and 11 (11.5%) without.

Published in Anesthesiology, the findings offer reassurance that different fasting instructions generally aren’t needed for people with diabetes in order to minimize the risk for perioperative pulmonary aspiration, lead author Anahi Perlas, MD, professor of anesthesiology and pain medicine at the University of Toronto, told this news organization.

“We never change practice completely based on a single study, but I think in general, based on our findings, that most diabetic patients aren’t any different from nondiabetics when it comes to their gastric content after fasting, and our standard fasting instructions seem to be just as effective in ensuring an empty stomach.”

But, she added, “If someone has symptoms of gastroparesis or when in doubt, we can always do a gastric ultrasound exam at the bedside and see whether the stomach is full or empty ... it’s very quick, and it’s not difficult to do.”
 

Expert Identifies Noteworthy Study Limitations

In an accompanying editorial, Mark A. Warner, MD, professor of anesthesiology at the Mayo Clinic in Rochester, Minnesota, said the findings “will be very helpful to anesthesiologists,” although he noted that the exclusion of people with a BMI > 40 is a limitation.

However, Michael Horowitz, MBBS, PhD, FRACP, director of the Endocrine and Metabolic Unit at the Royal Adelaide Hospital and professor of medicine at Adelaide Medical School in Adelaide, Australia, disputed the study’s conclusions. He noted that the sample was small, and the participants had an average A1c of 7.2%. Fewer than half had microvascular or neuropathic complications. Thus, they were healthier than the general population with diabetes.

“They’ve picked the wrong group of diabetics,” said Dr. Horowitz, who specializes in gastrointestinal complications of diabetes. “This is not a group where you would expect a very high prevalence of delayed emptying.”

Gastric emptying of solids and liquids varies widely even among healthy people and more so in those with type 2 diabetes. About a third of those with above-target A1c levels have gastroparesis, while those more in the target range tend to have accelerated emptying, he explained.

And regarding the use of gastric ultrasound for those who are symptomatic, Dr. Horowitz said, “The relationship of symptoms such as nausea, vomiting, fullness, whatever it may be, with the rate of gastric emptying is weak at best. The association is not simply cause and effect.”
 

Are the Fasting Guidelines Flawed, Regardless of Diabetes Status?

Dr. Horowitz also faulted the ASA’s 2017 guidance revision for allowing clear liquids to be consumed up to 2 hours in advance of anesthesia because it doesn’t distinguish between liquids with and without calories.

“Whether you have diabetes or not, if you are allowed to have a sugar drink up to 2 hours before your operation, the majority of people empty at about 4 kcal/min, so they will still have some of that drink in their stomach,” he said. “If you want an empty stomach, the ASA guidelines are wrong.”

That explains why the study found relatively high rates of “full stomach” in both groups, 15.5% of those with diabetes and 11.5% of those without, he said.
 

The GLP-1 Agonist Factor

Although the study didn’t address GLP-1 receptor agonist use, Dr. Warner did in his accompanying editorial, noting that the drugs’ rapid expansion “will likely change how we use perioperative fasting guidelines. With these medications delaying gastric emptying times, we now have another risk factor for pulmonary aspiration to consider when applying fasting guidelines. The inconsistent impact of GLP-1 agonists on gastric emptying, ranging from little to significant, makes it difficult for anesthesiologists to gauge whether or not patients taking GLP-1 agonists are likely to have preoperative gastric liquid or solid contents that could cause subsequent damage if regurgitated.”

Gastric ultrasound can be helpful in this situation, Dr. Warner wrote. In addition, he endorsed the 2023 ASA guidance, which calls for withholding daily-dosed GLP-1 agonists on the day of the surgery and the weekly formulations for a week. And if gastrointestinal symptoms are present, delay elective procedures.

But Dr. Horowitz said those recommendations are likely insufficient as well, pointing to data suggesting that daily liraglutide can delay gastric emptying for up to 16 weeks in about a third of patients. Such studies haven’t been conducted by the manufacturers, particularly on the once-weekly formulations, and the ensuing risk for aspiration isn’t known.

“The slowing occurs in much lower doses than are used for glucose lowering,” Dr. Horowitz said. “It is very likely that plasma levels will need to be extremely low to avoid gastric slowing. The current guidelines fail to appreciate this. So, to withhold the short-acting drugs for 1 day is probably wrong. And to stop long-acting drugs for 1 week is almost certainly wrong too.”

But as for what should be done, he said, “I don’t actually know what you do about it. And no one does because there are no data available to answer the question.”

The study received funding from the Physicians’ Services Incorporated Foundation and the Canadian Society of Anesthesiologists. Dr. Perlas received support for nonclinical time through a merit award from the Department of Anesthesiology and Pain Medicine, University of Toronto, and the Department of Anesthesia and Pain Management, Toronto Western Hospital, University Health Network. She is an executive editor of the journal Regional Anesthesia and Pain Medicine and does consulting work for FujiFilm SonoSite. Dr. Horowitz had no relevant disclosures.
 

A version of this article appeared on Medscape.com.

People with diabetes don’t have higher gastric volumes than those without diabetes after following standard preoperative fasting instructions, suggested a study from a team of anesthesiologist researchers.

However, an endocrinologist faulted the study in part because the participants appeared to be healthier than typical populations with type 1 and type 2 diabetes. Moreover, the issue is now further complicated by the widespread use of glucagon-like peptide-1 (GLP-1) receptor agonists for the treatment of both type 2 diabetes and weight loss. These drugs, which were introduced after the study’s enrollment period, work in part by delaying gastric emptying.

The new data come from a prospective study of 84 people with diabetes (85% with type 2) and 96 without diabetes, all with a body mass index (BMI) < 40, who were undergoing elective surgery. A gastric ultrasound was used to assess their gastric contents after they had followed the standard preoperative fasting guidelines of stopping solids 8 hours prior to the procedure and clearing liquids 2 hours prior.

There was no significant difference between the two groups in gastric volume (0.81 mL/kg with diabetes vs 0.87 mL/kg without) or in the proportion with “full stomach,” as designated by the American Society of Anesthesiologists (ASA) guidelines (any solid content or > 1.5 mL/kg of clear fluid), which was seen in 13 with diabetes (15.5%) and 11 (11.5%) without.

Published in Anesthesiology, the findings offer reassurance that different fasting instructions generally aren’t needed for people with diabetes in order to minimize the risk for perioperative pulmonary aspiration, lead author Anahi Perlas, MD, professor of anesthesiology and pain medicine at the University of Toronto, told this news organization.

“We never change practice completely based on a single study, but I think in general, based on our findings, that most diabetic patients aren’t any different from nondiabetics when it comes to their gastric content after fasting, and our standard fasting instructions seem to be just as effective in ensuring an empty stomach.”

But, she added, “If someone has symptoms of gastroparesis or when in doubt, we can always do a gastric ultrasound exam at the bedside and see whether the stomach is full or empty ... it’s very quick, and it’s not difficult to do.”
 

Expert Identifies Noteworthy Study Limitations

In an accompanying editorial, Mark A. Warner, MD, professor of anesthesiology at the Mayo Clinic in Rochester, Minnesota, said the findings “will be very helpful to anesthesiologists,” although he noted that the exclusion of people with a BMI > 40 is a limitation.

However, Michael Horowitz, MBBS, PhD, FRACP, director of the Endocrine and Metabolic Unit at the Royal Adelaide Hospital and professor of medicine at Adelaide Medical School in Adelaide, Australia, disputed the study’s conclusions. He noted that the sample was small, and the participants had an average A1c of 7.2%. Fewer than half had microvascular or neuropathic complications. Thus, they were healthier than the general population with diabetes.

“They’ve picked the wrong group of diabetics,” said Dr. Horowitz, who specializes in gastrointestinal complications of diabetes. “This is not a group where you would expect a very high prevalence of delayed emptying.”

Gastric emptying of solids and liquids varies widely even among healthy people and more so in those with type 2 diabetes. About a third of those with above-target A1c levels have gastroparesis, while those more in the target range tend to have accelerated emptying, he explained.

And regarding the use of gastric ultrasound for those who are symptomatic, Dr. Horowitz said, “The relationship of symptoms such as nausea, vomiting, fullness, whatever it may be, with the rate of gastric emptying is weak at best. The association is not simply cause and effect.”
 

Are the Fasting Guidelines Flawed, Regardless of Diabetes Status?

Dr. Horowitz also faulted the ASA’s 2017 guidance revision for allowing clear liquids to be consumed up to 2 hours in advance of anesthesia because it doesn’t distinguish between liquids with and without calories.

“Whether you have diabetes or not, if you are allowed to have a sugar drink up to 2 hours before your operation, the majority of people empty at about 4 kcal/min, so they will still have some of that drink in their stomach,” he said. “If you want an empty stomach, the ASA guidelines are wrong.”

That explains why the study found relatively high rates of “full stomach” in both groups, 15.5% of those with diabetes and 11.5% of those without, he said.
 

The GLP-1 Agonist Factor

Although the study didn’t address GLP-1 receptor agonist use, Dr. Warner did in his accompanying editorial, noting that the drugs’ rapid expansion “will likely change how we use perioperative fasting guidelines. With these medications delaying gastric emptying times, we now have another risk factor for pulmonary aspiration to consider when applying fasting guidelines. The inconsistent impact of GLP-1 agonists on gastric emptying, ranging from little to significant, makes it difficult for anesthesiologists to gauge whether or not patients taking GLP-1 agonists are likely to have preoperative gastric liquid or solid contents that could cause subsequent damage if regurgitated.”

Gastric ultrasound can be helpful in this situation, Dr. Warner wrote. In addition, he endorsed the 2023 ASA guidance, which calls for withholding daily-dosed GLP-1 agonists on the day of the surgery and the weekly formulations for a week. And if gastrointestinal symptoms are present, delay elective procedures.

But Dr. Horowitz said those recommendations are likely insufficient as well, pointing to data suggesting that daily liraglutide can delay gastric emptying for up to 16 weeks in about a third of patients. Such studies haven’t been conducted by the manufacturers, particularly on the once-weekly formulations, and the ensuing risk for aspiration isn’t known.

“The slowing occurs in much lower doses than are used for glucose lowering,” Dr. Horowitz said. “It is very likely that plasma levels will need to be extremely low to avoid gastric slowing. The current guidelines fail to appreciate this. So, to withhold the short-acting drugs for 1 day is probably wrong. And to stop long-acting drugs for 1 week is almost certainly wrong too.”

But as for what should be done, he said, “I don’t actually know what you do about it. And no one does because there are no data available to answer the question.”

The study received funding from the Physicians’ Services Incorporated Foundation and the Canadian Society of Anesthesiologists. Dr. Perlas received support for nonclinical time through a merit award from the Department of Anesthesiology and Pain Medicine, University of Toronto, and the Department of Anesthesia and Pain Management, Toronto Western Hospital, University Health Network. She is an executive editor of the journal Regional Anesthesia and Pain Medicine and does consulting work for FujiFilm SonoSite. Dr. Horowitz had no relevant disclosures.
 

A version of this article appeared on Medscape.com.

Two professional societies have issued new guidance for type 2 diabetes management in primary care, with one focused specifically on the use of the newer medications.

On April 19, 2024, the American College of Physicians (ACP) published Newer Pharmacologic Treatments in Adults With Type 2 Diabetes: A Clinical Guideline From the American College of Physicians. The internal medicine group recommends the use of glucagon-like peptide-1 (GLP-1) agonists, and sodium–glucose cotransporter-2 (SGLT2) inhibitors as second-line treatment after metformin. They also advise against the use of dipeptidyl peptidase-4 (DPP-4) inhibitors. 

The document was also presented simultaneously at the ACP annual meeting. 

And on April 15, the American Diabetes Association (ADA) posted its comprehensive Standards of Care in Diabetes—2024 Abridged for Primary Care Professionals as a follow-up to the December 2023 publication of its full-length Standards. Section 9, Pharmacologic Approaches to Glycemic Treatment, covers the same ground as the ACP guidelines.
 

General Agreement but Some Differences

The recommendations generally agree regarding medication use, although there are some differences. Both societies continue to endorse metformin and lifestyle modification as first-line therapy for glycemic management in type 2 diabetes. However, while ADA also gives the option of initial combination therapy with prioritization of avoiding hypoglycemia, ACP advises adding new medications only if glycemic goals aren’t met with lifestyle and metformin alone. 

The new ACP document gives two general recommendations:

1. Add an SGLT2 inhibitor or a GLP-1 agonist to metformin and lifestyle modifications in adults with type 2 diabetes and inadequate glycemic control. 

*Use an SGLT2 inhibitor to reduce the risk for all-cause mortality, major adverse cardiovascular events, progression of chronic kidney disease, and hospitalization due to congestive heart failure.

*Use a GLP-1 agonist to reduce the risk for all-cause mortality, major adverse cardiovascular events, and stroke.

2. ACP recommends against adding a DPP-4 inhibitor to metformin and lifestyle modifications in adults with type 2 diabetes and inadequate glycemic control to reduce morbidity and all-cause mortality.

Both ADA and ACP advise using SGLT2 inhibitors in patients with congestive heart failure and/or chronic kidney disease, and using GLP-1 agonists in patients for whom weight management is a priority. The ADA also advises using agents of either drug class with proven cardiovascular benefit for people with type 2 diabetes who have established cardiovascular disease or who are at high risk.

ADA doesn’t advise against the use of DPP-4 inhibitors but doesn’t prioritize them either. Both insulin and sulfonylureas remain options for both, but they also are lower priority due to their potential for causing hypoglycemia. ACP says that sulfonylureas and long-acting insulin are “inferior to SGLT2 inhibitors and GLP-1 agonists in reducing all-cause mortality and morbidity but may still have some limited value for glycemic control.” 

The two groups continue to differ regarding A1c goals, although both recommend individualization. The ACP generally advises levels between 7% and 8% for most adults with type 2 diabetes, and de-intensification of pharmacologic agents for those with A1c levels below 6.5%. On the other hand, ADA recommends A1c levels < 7% as long as that can be achieved safely. 

This is the first time ACP has addressed this topic in a guideline, panel chair Carolyn J. Crandall, MD, told this news organization. “Diabetes treatment, of course, is our bread and butter…but what we had done before was based on the need to identify a target, like glycosylated hemoglobin. What patients and physicians really want to know now is, who should receive these new drugs? Should they receive these new drugs? And what benefits do they have?”

Added Dr. Crandall, who is professor of medicine at the David Geffen School of Medicine at the University of California, Los Angeles. “At ACP we have a complicated process that I’m actually very proud of, where we’ve asked a lay public panel, as well at the members of our guideline committee, to rank what’s most important in terms of the health outcomes for this condition…And then we look at how to balance those risks and benefits to make the recommendations.” 

In the same Annals of Internal Medicine issue are two systematic reviews/meta-analyses that informed the new document, one on drug effectiveness and the other on cost-effectiveness. 

In the accompanying editorial from Fatima Z. Syed, MD, an internist and medical weight management specialist at Duke University Division of General Internal Medicine, Durham, North Carolina, she notes, “the potential added benefits of these newer medications, including weight loss and cardiovascular and renal benefits, motivate their prescription, but cost and prior authorization hurdles can bar their use.”

Dr. Syed cites as “missing” from the ACP guidelines an analysis of comorbidities, including obesity. The reason for that, according to the document, is that “weight loss, as measured by percentage of participants who achieved at least 10% total body weight loss, was a prioritized outcome, but data were insufficient for network meta-analysis.”

However, Dr. Syed notes that factoring in weight loss could improve the cost-effectiveness of the newer medications. She points out that the ADA Standards suggest a GLP-1 agonist with or without metformin as initial therapy options for people with newly diagnosed type 2 diabetes who might benefit from weight loss.

“The ACP guidelines strengthen the case for metformin as first-line medication for diabetes when comorbid conditions are not present. Metformin is cost-effective and has excellent hemoglobin A1c reduction. The accompanying economic analysis tells us that in the absence of comorbidity, the newer medication classes do not seem to be cost-effective. However, given that many patients with type 2 diabetes have obesity or existing cardiovascular or renal disease, the choice and accessibility of newer medications can be nuanced. The cost-effectiveness of GLP1 agonists and SGLT2 inhibitors as initial diabetes therapy in the setting of various comorbid conditions warrants careful exploration.”

Dr. Crandall has no disclosures. Dr. Syed disclosed that her husband is employed by Blue Cross Blue Shield of North Carolina.

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

Two professional societies have issued new guidance for type 2 diabetes management in primary care, with one focused specifically on the use of the newer medications.

On April 19, 2024, the American College of Physicians (ACP) published Newer Pharmacologic Treatments in Adults With Type 2 Diabetes: A Clinical Guideline From the American College of Physicians. The internal medicine group recommends the use of glucagon-like peptide-1 (GLP-1) agonists, and sodium–glucose cotransporter-2 (SGLT2) inhibitors as second-line treatment after metformin. They also advise against the use of dipeptidyl peptidase-4 (DPP-4) inhibitors. 

The document was also presented simultaneously at the ACP annual meeting. 

And on April 15, the American Diabetes Association (ADA) posted its comprehensive Standards of Care in Diabetes—2024 Abridged for Primary Care Professionals as a follow-up to the December 2023 publication of its full-length Standards. Section 9, Pharmacologic Approaches to Glycemic Treatment, covers the same ground as the ACP guidelines.
 

General Agreement but Some Differences

The recommendations generally agree regarding medication use, although there are some differences. Both societies continue to endorse metformin and lifestyle modification as first-line therapy for glycemic management in type 2 diabetes. However, while ADA also gives the option of initial combination therapy with prioritization of avoiding hypoglycemia, ACP advises adding new medications only if glycemic goals aren’t met with lifestyle and metformin alone. 

The new ACP document gives two general recommendations:

1. Add an SGLT2 inhibitor or a GLP-1 agonist to metformin and lifestyle modifications in adults with type 2 diabetes and inadequate glycemic control. 

*Use an SGLT2 inhibitor to reduce the risk for all-cause mortality, major adverse cardiovascular events, progression of chronic kidney disease, and hospitalization due to congestive heart failure.

*Use a GLP-1 agonist to reduce the risk for all-cause mortality, major adverse cardiovascular events, and stroke.

2. ACP recommends against adding a DPP-4 inhibitor to metformin and lifestyle modifications in adults with type 2 diabetes and inadequate glycemic control to reduce morbidity and all-cause mortality.

Both ADA and ACP advise using SGLT2 inhibitors in patients with congestive heart failure and/or chronic kidney disease, and using GLP-1 agonists in patients for whom weight management is a priority. The ADA also advises using agents of either drug class with proven cardiovascular benefit for people with type 2 diabetes who have established cardiovascular disease or who are at high risk.

ADA doesn’t advise against the use of DPP-4 inhibitors but doesn’t prioritize them either. Both insulin and sulfonylureas remain options for both, but they also are lower priority due to their potential for causing hypoglycemia. ACP says that sulfonylureas and long-acting insulin are “inferior to SGLT2 inhibitors and GLP-1 agonists in reducing all-cause mortality and morbidity but may still have some limited value for glycemic control.” 

The two groups continue to differ regarding A1c goals, although both recommend individualization. The ACP generally advises levels between 7% and 8% for most adults with type 2 diabetes, and de-intensification of pharmacologic agents for those with A1c levels below 6.5%. On the other hand, ADA recommends A1c levels < 7% as long as that can be achieved safely. 

This is the first time ACP has addressed this topic in a guideline, panel chair Carolyn J. Crandall, MD, told this news organization. “Diabetes treatment, of course, is our bread and butter…but what we had done before was based on the need to identify a target, like glycosylated hemoglobin. What patients and physicians really want to know now is, who should receive these new drugs? Should they receive these new drugs? And what benefits do they have?”

Added Dr. Crandall, who is professor of medicine at the David Geffen School of Medicine at the University of California, Los Angeles. “At ACP we have a complicated process that I’m actually very proud of, where we’ve asked a lay public panel, as well at the members of our guideline committee, to rank what’s most important in terms of the health outcomes for this condition…And then we look at how to balance those risks and benefits to make the recommendations.” 

In the same Annals of Internal Medicine issue are two systematic reviews/meta-analyses that informed the new document, one on drug effectiveness and the other on cost-effectiveness. 

In the accompanying editorial from Fatima Z. Syed, MD, an internist and medical weight management specialist at Duke University Division of General Internal Medicine, Durham, North Carolina, she notes, “the potential added benefits of these newer medications, including weight loss and cardiovascular and renal benefits, motivate their prescription, but cost and prior authorization hurdles can bar their use.”

Dr. Syed cites as “missing” from the ACP guidelines an analysis of comorbidities, including obesity. The reason for that, according to the document, is that “weight loss, as measured by percentage of participants who achieved at least 10% total body weight loss, was a prioritized outcome, but data were insufficient for network meta-analysis.”

However, Dr. Syed notes that factoring in weight loss could improve the cost-effectiveness of the newer medications. She points out that the ADA Standards suggest a GLP-1 agonist with or without metformin as initial therapy options for people with newly diagnosed type 2 diabetes who might benefit from weight loss.

“The ACP guidelines strengthen the case for metformin as first-line medication for diabetes when comorbid conditions are not present. Metformin is cost-effective and has excellent hemoglobin A1c reduction. The accompanying economic analysis tells us that in the absence of comorbidity, the newer medication classes do not seem to be cost-effective. However, given that many patients with type 2 diabetes have obesity or existing cardiovascular or renal disease, the choice and accessibility of newer medications can be nuanced. The cost-effectiveness of GLP1 agonists and SGLT2 inhibitors as initial diabetes therapy in the setting of various comorbid conditions warrants careful exploration.”

Dr. Crandall has no disclosures. Dr. Syed disclosed that her husband is employed by Blue Cross Blue Shield of North Carolina.

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

Two professional societies have issued new guidance for type 2 diabetes management in primary care, with one focused specifically on the use of the newer medications.

On April 19, 2024, the American College of Physicians (ACP) published Newer Pharmacologic Treatments in Adults With Type 2 Diabetes: A Clinical Guideline From the American College of Physicians. The internal medicine group recommends the use of glucagon-like peptide-1 (GLP-1) agonists, and sodium–glucose cotransporter-2 (SGLT2) inhibitors as second-line treatment after metformin. They also advise against the use of dipeptidyl peptidase-4 (DPP-4) inhibitors. 

The document was also presented simultaneously at the ACP annual meeting. 

And on April 15, the American Diabetes Association (ADA) posted its comprehensive Standards of Care in Diabetes—2024 Abridged for Primary Care Professionals as a follow-up to the December 2023 publication of its full-length Standards. Section 9, Pharmacologic Approaches to Glycemic Treatment, covers the same ground as the ACP guidelines.
 

General Agreement but Some Differences

The recommendations generally agree regarding medication use, although there are some differences. Both societies continue to endorse metformin and lifestyle modification as first-line therapy for glycemic management in type 2 diabetes. However, while ADA also gives the option of initial combination therapy with prioritization of avoiding hypoglycemia, ACP advises adding new medications only if glycemic goals aren’t met with lifestyle and metformin alone. 

The new ACP document gives two general recommendations:

1. Add an SGLT2 inhibitor or a GLP-1 agonist to metformin and lifestyle modifications in adults with type 2 diabetes and inadequate glycemic control. 

*Use an SGLT2 inhibitor to reduce the risk for all-cause mortality, major adverse cardiovascular events, progression of chronic kidney disease, and hospitalization due to congestive heart failure.

*Use a GLP-1 agonist to reduce the risk for all-cause mortality, major adverse cardiovascular events, and stroke.

2. ACP recommends against adding a DPP-4 inhibitor to metformin and lifestyle modifications in adults with type 2 diabetes and inadequate glycemic control to reduce morbidity and all-cause mortality.

Both ADA and ACP advise using SGLT2 inhibitors in patients with congestive heart failure and/or chronic kidney disease, and using GLP-1 agonists in patients for whom weight management is a priority. The ADA also advises using agents of either drug class with proven cardiovascular benefit for people with type 2 diabetes who have established cardiovascular disease or who are at high risk.

ADA doesn’t advise against the use of DPP-4 inhibitors but doesn’t prioritize them either. Both insulin and sulfonylureas remain options for both, but they also are lower priority due to their potential for causing hypoglycemia. ACP says that sulfonylureas and long-acting insulin are “inferior to SGLT2 inhibitors and GLP-1 agonists in reducing all-cause mortality and morbidity but may still have some limited value for glycemic control.” 

The two groups continue to differ regarding A1c goals, although both recommend individualization. The ACP generally advises levels between 7% and 8% for most adults with type 2 diabetes, and de-intensification of pharmacologic agents for those with A1c levels below 6.5%. On the other hand, ADA recommends A1c levels < 7% as long as that can be achieved safely. 

This is the first time ACP has addressed this topic in a guideline, panel chair Carolyn J. Crandall, MD, told this news organization. “Diabetes treatment, of course, is our bread and butter…but what we had done before was based on the need to identify a target, like glycosylated hemoglobin. What patients and physicians really want to know now is, who should receive these new drugs? Should they receive these new drugs? And what benefits do they have?”

Added Dr. Crandall, who is professor of medicine at the David Geffen School of Medicine at the University of California, Los Angeles. “At ACP we have a complicated process that I’m actually very proud of, where we’ve asked a lay public panel, as well at the members of our guideline committee, to rank what’s most important in terms of the health outcomes for this condition…And then we look at how to balance those risks and benefits to make the recommendations.” 

In the same Annals of Internal Medicine issue are two systematic reviews/meta-analyses that informed the new document, one on drug effectiveness and the other on cost-effectiveness. 

In the accompanying editorial from Fatima Z. Syed, MD, an internist and medical weight management specialist at Duke University Division of General Internal Medicine, Durham, North Carolina, she notes, “the potential added benefits of these newer medications, including weight loss and cardiovascular and renal benefits, motivate their prescription, but cost and prior authorization hurdles can bar their use.”

Dr. Syed cites as “missing” from the ACP guidelines an analysis of comorbidities, including obesity. The reason for that, according to the document, is that “weight loss, as measured by percentage of participants who achieved at least 10% total body weight loss, was a prioritized outcome, but data were insufficient for network meta-analysis.”

However, Dr. Syed notes that factoring in weight loss could improve the cost-effectiveness of the newer medications. She points out that the ADA Standards suggest a GLP-1 agonist with or without metformin as initial therapy options for people with newly diagnosed type 2 diabetes who might benefit from weight loss.

“The ACP guidelines strengthen the case for metformin as first-line medication for diabetes when comorbid conditions are not present. Metformin is cost-effective and has excellent hemoglobin A1c reduction. The accompanying economic analysis tells us that in the absence of comorbidity, the newer medication classes do not seem to be cost-effective. However, given that many patients with type 2 diabetes have obesity or existing cardiovascular or renal disease, the choice and accessibility of newer medications can be nuanced. The cost-effectiveness of GLP1 agonists and SGLT2 inhibitors as initial diabetes therapy in the setting of various comorbid conditions warrants careful exploration.”

Dr. Crandall has no disclosures. Dr. Syed disclosed that her husband is employed by Blue Cross Blue Shield of North Carolina.

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

The US Food and Drug Administration (FDA) has designated the Eversense (Sensionics, Inc; Ascencia Diabetes Care) implanted continuous glucose monitor (CGM) an “integrated CGM,” meaning it can be used in conjunction with insulin pumps as part of an automated insulin delivery system (AID). 

The Eversense now joins Dexcom’s G6 and G7 and the Freestyle Libre 2 Plus in being compatible with multiple different branded insulin pumps as part of AID systems, and it is the only implantable one. 

The sensor device is inserted under the skin of the patient’s upper arm by a healthcare provider and a transmitter is worn over it on the skin. The FDA approved the Eversense in June 2018 for 3-month use and in February 2022  for use up to 6 months. It is indicated for people with diabetes aged 18 years and older.

Fingerstick blood glucose measurements are still required for calibration once a day after day 21, when symptoms don’t match the CGM information, or when taking tetracycline medications. 

According to Sensionics, the Eversense is “the most accurate CGM in the critical low glucose ranges with essentially no compression lows.” The latter refers to ‘false low’ alarms that sometimes occur when a person presses on the device, such as during sleep.

“As we look ahead, we are focused on progressing our partnership discussions and software developments, and look forward to providing more updates,” Sensionics said in a statement.
 

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

The US Food and Drug Administration (FDA) has designated the Eversense (Sensionics, Inc; Ascencia Diabetes Care) implanted continuous glucose monitor (CGM) an “integrated CGM,” meaning it can be used in conjunction with insulin pumps as part of an automated insulin delivery system (AID). 

The Eversense now joins Dexcom’s G6 and G7 and the Freestyle Libre 2 Plus in being compatible with multiple different branded insulin pumps as part of AID systems, and it is the only implantable one. 

The sensor device is inserted under the skin of the patient’s upper arm by a healthcare provider and a transmitter is worn over it on the skin. The FDA approved the Eversense in June 2018 for 3-month use and in February 2022  for use up to 6 months. It is indicated for people with diabetes aged 18 years and older.

Fingerstick blood glucose measurements are still required for calibration once a day after day 21, when symptoms don’t match the CGM information, or when taking tetracycline medications. 

According to Sensionics, the Eversense is “the most accurate CGM in the critical low glucose ranges with essentially no compression lows.” The latter refers to ‘false low’ alarms that sometimes occur when a person presses on the device, such as during sleep.

“As we look ahead, we are focused on progressing our partnership discussions and software developments, and look forward to providing more updates,” Sensionics said in a statement.
 

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

The US Food and Drug Administration (FDA) has designated the Eversense (Sensionics, Inc; Ascencia Diabetes Care) implanted continuous glucose monitor (CGM) an “integrated CGM,” meaning it can be used in conjunction with insulin pumps as part of an automated insulin delivery system (AID). 

The Eversense now joins Dexcom’s G6 and G7 and the Freestyle Libre 2 Plus in being compatible with multiple different branded insulin pumps as part of AID systems, and it is the only implantable one. 

The sensor device is inserted under the skin of the patient’s upper arm by a healthcare provider and a transmitter is worn over it on the skin. The FDA approved the Eversense in June 2018 for 3-month use and in February 2022  for use up to 6 months. It is indicated for people with diabetes aged 18 years and older.

Fingerstick blood glucose measurements are still required for calibration once a day after day 21, when symptoms don’t match the CGM information, or when taking tetracycline medications. 

According to Sensionics, the Eversense is “the most accurate CGM in the critical low glucose ranges with essentially no compression lows.” The latter refers to ‘false low’ alarms that sometimes occur when a person presses on the device, such as during sleep.

“As we look ahead, we are focused on progressing our partnership discussions and software developments, and look forward to providing more updates,” Sensionics said in a statement.
 

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