Kathleen Doheny

The woman, in severe pain from hip and knee osteoarthritis, was confined to a wheelchair and had been told that would likely be for life. To qualify for hip replacement surgery, she needed to lose 100 pounds, a seemingly impossible goal. But she wanted to try.

“We tried a couple of medicines — oral medicines off-label — topiramate, phentermine,” said Leslie Golden, MD, MPH, DABM, a family medicine physician and obesity medicine specialist in Watertown, Wisconsin, 42 miles northeast of Madison.

They weren’t enough. But then Golden turned to glucagon-like peptide 1 (GLP-1) receptor agonists, and they delivered.

“She did lose a significant amount of weight and was able to get the hip replacement,” said Golden.

It took a couple of years. However, seeing her walk into her office, rather than wheel in, “is still one of the joys of my practice,” Golden said. “She’s so grateful. She felt everyone else had written her off.”

As she told Golden: “If I fell and broke my leg today, they would take me to surgery without concern.”

Because her hip replacement was viewed as a nonemergency procedure, the accepted threshold for elective safe surgery was a body mass index (BMI) < 40. That BMI cutoff can vary from provider to provider and medical facility to medical facility but is often required for other surgeries as well, including kidney and lung transplants, gender-affirming surgery, bariatric surgery, hernia surgery, and in vitro fertilization procedures.

Golden is at the forefront of a growing trend — obesity medicine physicians collaborating with surgeons to prescribe the more effective GLP-1s and get surgery candidates to the starting line. She worked with Rajit Chakravarty, MD, an adult reconstructive surgeon who practices in Watertown and nearby Madison, to oversee the weight loss.

 

High BMIs & Surgery Issues

High BMIs have long been linked with postsurgery complications, poor wound healing, and other issues, although some research now is questioning some of those associations. Even so, surgeons have long stressed weight loss for their patients with obesity before orthopedic and other procedures.

These days, surgeons are more likely to need to have that talk. In the last decade, the age-adjusted prevalence of severe obesity — a BMI of ≥ 40 — has increased from 7.7% to 9.7% of US adults. The number of joint replacements is also rising — more than 700,000 total knee arthroplasty (TKA) and more than 450,000 total hip arthroplasty (THA), according to the American Academy of Orthopaedic Surgeons. As the population ages, those numbers are expected to increase.

 

Making the GLP-1 Choice

GLP-1s aren’t the only choice, of course. But they’re often more effective, as Golden found, than other medications. And when his patients with obesity are offered bariatric surgery or GLP-1s, “people definitely want to avoid the bariatric surgery,” Chakravarty said.

With the Food and Drug Administration (FDA) approval of semaglutide (Wegovy) in June 2021 for chronic weight management and then tirzepatide (Zepbound) in November 2023, interest has boomed, he said, among his surgery candidates with a high BMI.

The FDA approved Wegovy based on clinical trials, including one in which participants lost an average of 12.4% of initial body weight compared with those on placebo. It approved Zepbound based on clinical trials, including one in which those on Zepbound lost an average of 18% of their body weight, compared with those on placebo.

The wheelchair-bound woman, now 65, began with a BMI of 63, Golden said. She negotiated a cutoff of 45 with the surgeon and got the go-ahead. Currently, her BMI is 36 as she stayed on the medications.

Beyond the benefit of GLP-1s helping patients meet the BMI cutoff, some research finds fewer postoperative infections and readmissions with their use. This study found the medications did lower both, and another found reduced readmissions and complications.

 

Growing Partnerships, Increasing Success

Helping patients lose weight isn’t just about lowering the BMI, Chakravarty pointed out. The aim is to improve nutritional health — to teach patients how to eat healthfully for their needs, in turn improving other health barometers. Referring them to an obesity medicine physician helps to meet those goals.

When Daniel Wiznia, MD, a Yale Medicine orthopedic surgeon and codirector of the Avascular Necrosis Program, has a patient who must delay a TKA or THA until they meet a BMI cutoff, he refers that patient to the Yale Medicine Center for Weight Management, New Haven, Connecticut, to learn about weight loss, including the options of anti-obesity medications or bariatric surgery.

Taking the GLP-1s can be a game changer, according to Wiznia and John Morton, MD, MPH, FACS, FASMBS, Yale’s medical director of Bariatric Surgery and professor and vice chair of surgery, who is a physician-director of the center. The program includes other options, such as bariatric surgery, and emphasizes diet and other lifestyle measures. GLP-1s give about a 15% weight loss, Morton said, compared with bariatric surgery providing up to 30%.

Sarah Stombaugh, MD, a family medicine and obesity medicine physician in Charlottesville, Virginia, often gets referrals from two orthopedic surgeons in her community. One recent patient in her early 60s had a BMI of 43.2, too high to qualify for the TKA she needed. On GLP-1s, the initial goal was to decrease a weight of 244 to 225, bringing the BMI to 39.9. The woman did that, then kept losing before her surgery was scheduled, getting to a weight of 210 or a BMI of 37 and staying there for 3 months before the surgery.

She had the TKA, and 5 months out, she is doing well, Stombaugh said. “We do medical weight loss primarily with the GLP-1s because they’re simply the best, the most effective,” Stombaugh said. She does occasionally use oral medications such as naltrexone/bupropion (Contrave).

Stombaugh sees the collaborating trend as still evolving. When she attends obesity medicine conferences, not all her colleagues report they are partnering with surgeons. But she predicts the practice will increase, saying the popularization of what she terms the more effective GLP-1 medications Wegovy and Zepbound is driving it. Partnering with the surgeon requires a conversation at the beginning, when the referral is made, about goals. After that, she sees her patient monthly and sends progress notes to the surgeon.

Golden collaborates with three orthopedic groups in her area, primarily for knee and hip surgeries, but has also helped patients meet the BMI cutoff before spine-related surgeries. She is helping a lung transplant patient now. She has seen several patients who must meet BMI requirements before starting in vitro fertilization, due to the need for conscious sedation for egg retrieval. She has had a few patients who had to meet a BMI cutoff for nonemergency hernia repair.

 

Insurance Issues

Insurance remains an issue for the pricey medications. “Only about a third of patients are routinely covered with insurance,” Morton said.

However, it’s improving, he said. Golden also finds about a third of private payers cover the medication but tries to use manufacturers’ coupons to help defray the costs (from about $1000 or $1400 to about $500 a month). She has sometimes gotten enough samples to get patients to their BMI goal

Morton consulted for Novo Nordisk, Eli Lilly, Olympus, Teleflex, and Johnson & Johnson.

A version of this article appeared on Medscape.com.

The woman, in severe pain from hip and knee osteoarthritis, was confined to a wheelchair and had been told that would likely be for life. To qualify for hip replacement surgery, she needed to lose 100 pounds, a seemingly impossible goal. But she wanted to try.

“We tried a couple of medicines — oral medicines off-label — topiramate, phentermine,” said Leslie Golden, MD, MPH, DABM, a family medicine physician and obesity medicine specialist in Watertown, Wisconsin, 42 miles northeast of Madison.

They weren’t enough. But then Golden turned to glucagon-like peptide 1 (GLP-1) receptor agonists, and they delivered.

“She did lose a significant amount of weight and was able to get the hip replacement,” said Golden.

It took a couple of years. However, seeing her walk into her office, rather than wheel in, “is still one of the joys of my practice,” Golden said. “She’s so grateful. She felt everyone else had written her off.”

As she told Golden: “If I fell and broke my leg today, they would take me to surgery without concern.”

Because her hip replacement was viewed as a nonemergency procedure, the accepted threshold for elective safe surgery was a body mass index (BMI) < 40. That BMI cutoff can vary from provider to provider and medical facility to medical facility but is often required for other surgeries as well, including kidney and lung transplants, gender-affirming surgery, bariatric surgery, hernia surgery, and in vitro fertilization procedures.

Golden is at the forefront of a growing trend — obesity medicine physicians collaborating with surgeons to prescribe the more effective GLP-1s and get surgery candidates to the starting line. She worked with Rajit Chakravarty, MD, an adult reconstructive surgeon who practices in Watertown and nearby Madison, to oversee the weight loss.

 

High BMIs & Surgery Issues

High BMIs have long been linked with postsurgery complications, poor wound healing, and other issues, although some research now is questioning some of those associations. Even so, surgeons have long stressed weight loss for their patients with obesity before orthopedic and other procedures.

These days, surgeons are more likely to need to have that talk. In the last decade, the age-adjusted prevalence of severe obesity — a BMI of ≥ 40 — has increased from 7.7% to 9.7% of US adults. The number of joint replacements is also rising — more than 700,000 total knee arthroplasty (TKA) and more than 450,000 total hip arthroplasty (THA), according to the American Academy of Orthopaedic Surgeons. As the population ages, those numbers are expected to increase.

 

Making the GLP-1 Choice

GLP-1s aren’t the only choice, of course. But they’re often more effective, as Golden found, than other medications. And when his patients with obesity are offered bariatric surgery or GLP-1s, “people definitely want to avoid the bariatric surgery,” Chakravarty said.

With the Food and Drug Administration (FDA) approval of semaglutide (Wegovy) in June 2021 for chronic weight management and then tirzepatide (Zepbound) in November 2023, interest has boomed, he said, among his surgery candidates with a high BMI.

The FDA approved Wegovy based on clinical trials, including one in which participants lost an average of 12.4% of initial body weight compared with those on placebo. It approved Zepbound based on clinical trials, including one in which those on Zepbound lost an average of 18% of their body weight, compared with those on placebo.

The wheelchair-bound woman, now 65, began with a BMI of 63, Golden said. She negotiated a cutoff of 45 with the surgeon and got the go-ahead. Currently, her BMI is 36 as she stayed on the medications.

Beyond the benefit of GLP-1s helping patients meet the BMI cutoff, some research finds fewer postoperative infections and readmissions with their use. This study found the medications did lower both, and another found reduced readmissions and complications.

 

Growing Partnerships, Increasing Success

Helping patients lose weight isn’t just about lowering the BMI, Chakravarty pointed out. The aim is to improve nutritional health — to teach patients how to eat healthfully for their needs, in turn improving other health barometers. Referring them to an obesity medicine physician helps to meet those goals.

When Daniel Wiznia, MD, a Yale Medicine orthopedic surgeon and codirector of the Avascular Necrosis Program, has a patient who must delay a TKA or THA until they meet a BMI cutoff, he refers that patient to the Yale Medicine Center for Weight Management, New Haven, Connecticut, to learn about weight loss, including the options of anti-obesity medications or bariatric surgery.

Taking the GLP-1s can be a game changer, according to Wiznia and John Morton, MD, MPH, FACS, FASMBS, Yale’s medical director of Bariatric Surgery and professor and vice chair of surgery, who is a physician-director of the center. The program includes other options, such as bariatric surgery, and emphasizes diet and other lifestyle measures. GLP-1s give about a 15% weight loss, Morton said, compared with bariatric surgery providing up to 30%.

Sarah Stombaugh, MD, a family medicine and obesity medicine physician in Charlottesville, Virginia, often gets referrals from two orthopedic surgeons in her community. One recent patient in her early 60s had a BMI of 43.2, too high to qualify for the TKA she needed. On GLP-1s, the initial goal was to decrease a weight of 244 to 225, bringing the BMI to 39.9. The woman did that, then kept losing before her surgery was scheduled, getting to a weight of 210 or a BMI of 37 and staying there for 3 months before the surgery.

She had the TKA, and 5 months out, she is doing well, Stombaugh said. “We do medical weight loss primarily with the GLP-1s because they’re simply the best, the most effective,” Stombaugh said. She does occasionally use oral medications such as naltrexone/bupropion (Contrave).

Stombaugh sees the collaborating trend as still evolving. When she attends obesity medicine conferences, not all her colleagues report they are partnering with surgeons. But she predicts the practice will increase, saying the popularization of what she terms the more effective GLP-1 medications Wegovy and Zepbound is driving it. Partnering with the surgeon requires a conversation at the beginning, when the referral is made, about goals. After that, she sees her patient monthly and sends progress notes to the surgeon.

Golden collaborates with three orthopedic groups in her area, primarily for knee and hip surgeries, but has also helped patients meet the BMI cutoff before spine-related surgeries. She is helping a lung transplant patient now. She has seen several patients who must meet BMI requirements before starting in vitro fertilization, due to the need for conscious sedation for egg retrieval. She has had a few patients who had to meet a BMI cutoff for nonemergency hernia repair.

 

Insurance Issues

Insurance remains an issue for the pricey medications. “Only about a third of patients are routinely covered with insurance,” Morton said.

However, it’s improving, he said. Golden also finds about a third of private payers cover the medication but tries to use manufacturers’ coupons to help defray the costs (from about $1000 or $1400 to about $500 a month). She has sometimes gotten enough samples to get patients to their BMI goal

Morton consulted for Novo Nordisk, Eli Lilly, Olympus, Teleflex, and Johnson & Johnson.

A version of this article appeared on Medscape.com.

The woman, in severe pain from hip and knee osteoarthritis, was confined to a wheelchair and had been told that would likely be for life. To qualify for hip replacement surgery, she needed to lose 100 pounds, a seemingly impossible goal. But she wanted to try.

“We tried a couple of medicines — oral medicines off-label — topiramate, phentermine,” said Leslie Golden, MD, MPH, DABM, a family medicine physician and obesity medicine specialist in Watertown, Wisconsin, 42 miles northeast of Madison.

They weren’t enough. But then Golden turned to glucagon-like peptide 1 (GLP-1) receptor agonists, and they delivered.

“She did lose a significant amount of weight and was able to get the hip replacement,” said Golden.

It took a couple of years. However, seeing her walk into her office, rather than wheel in, “is still one of the joys of my practice,” Golden said. “She’s so grateful. She felt everyone else had written her off.”

As she told Golden: “If I fell and broke my leg today, they would take me to surgery without concern.”

Because her hip replacement was viewed as a nonemergency procedure, the accepted threshold for elective safe surgery was a body mass index (BMI) < 40. That BMI cutoff can vary from provider to provider and medical facility to medical facility but is often required for other surgeries as well, including kidney and lung transplants, gender-affirming surgery, bariatric surgery, hernia surgery, and in vitro fertilization procedures.

Golden is at the forefront of a growing trend — obesity medicine physicians collaborating with surgeons to prescribe the more effective GLP-1s and get surgery candidates to the starting line. She worked with Rajit Chakravarty, MD, an adult reconstructive surgeon who practices in Watertown and nearby Madison, to oversee the weight loss.

 

High BMIs & Surgery Issues

High BMIs have long been linked with postsurgery complications, poor wound healing, and other issues, although some research now is questioning some of those associations. Even so, surgeons have long stressed weight loss for their patients with obesity before orthopedic and other procedures.

These days, surgeons are more likely to need to have that talk. In the last decade, the age-adjusted prevalence of severe obesity — a BMI of ≥ 40 — has increased from 7.7% to 9.7% of US adults. The number of joint replacements is also rising — more than 700,000 total knee arthroplasty (TKA) and more than 450,000 total hip arthroplasty (THA), according to the American Academy of Orthopaedic Surgeons. As the population ages, those numbers are expected to increase.

 

Making the GLP-1 Choice

GLP-1s aren’t the only choice, of course. But they’re often more effective, as Golden found, than other medications. And when his patients with obesity are offered bariatric surgery or GLP-1s, “people definitely want to avoid the bariatric surgery,” Chakravarty said.

With the Food and Drug Administration (FDA) approval of semaglutide (Wegovy) in June 2021 for chronic weight management and then tirzepatide (Zepbound) in November 2023, interest has boomed, he said, among his surgery candidates with a high BMI.

The FDA approved Wegovy based on clinical trials, including one in which participants lost an average of 12.4% of initial body weight compared with those on placebo. It approved Zepbound based on clinical trials, including one in which those on Zepbound lost an average of 18% of their body weight, compared with those on placebo.

The wheelchair-bound woman, now 65, began with a BMI of 63, Golden said. She negotiated a cutoff of 45 with the surgeon and got the go-ahead. Currently, her BMI is 36 as she stayed on the medications.

Beyond the benefit of GLP-1s helping patients meet the BMI cutoff, some research finds fewer postoperative infections and readmissions with their use. This study found the medications did lower both, and another found reduced readmissions and complications.

 

Growing Partnerships, Increasing Success

Helping patients lose weight isn’t just about lowering the BMI, Chakravarty pointed out. The aim is to improve nutritional health — to teach patients how to eat healthfully for their needs, in turn improving other health barometers. Referring them to an obesity medicine physician helps to meet those goals.

When Daniel Wiznia, MD, a Yale Medicine orthopedic surgeon and codirector of the Avascular Necrosis Program, has a patient who must delay a TKA or THA until they meet a BMI cutoff, he refers that patient to the Yale Medicine Center for Weight Management, New Haven, Connecticut, to learn about weight loss, including the options of anti-obesity medications or bariatric surgery.

Taking the GLP-1s can be a game changer, according to Wiznia and John Morton, MD, MPH, FACS, FASMBS, Yale’s medical director of Bariatric Surgery and professor and vice chair of surgery, who is a physician-director of the center. The program includes other options, such as bariatric surgery, and emphasizes diet and other lifestyle measures. GLP-1s give about a 15% weight loss, Morton said, compared with bariatric surgery providing up to 30%.

Sarah Stombaugh, MD, a family medicine and obesity medicine physician in Charlottesville, Virginia, often gets referrals from two orthopedic surgeons in her community. One recent patient in her early 60s had a BMI of 43.2, too high to qualify for the TKA she needed. On GLP-1s, the initial goal was to decrease a weight of 244 to 225, bringing the BMI to 39.9. The woman did that, then kept losing before her surgery was scheduled, getting to a weight of 210 or a BMI of 37 and staying there for 3 months before the surgery.

She had the TKA, and 5 months out, she is doing well, Stombaugh said. “We do medical weight loss primarily with the GLP-1s because they’re simply the best, the most effective,” Stombaugh said. She does occasionally use oral medications such as naltrexone/bupropion (Contrave).

Stombaugh sees the collaborating trend as still evolving. When she attends obesity medicine conferences, not all her colleagues report they are partnering with surgeons. But she predicts the practice will increase, saying the popularization of what she terms the more effective GLP-1 medications Wegovy and Zepbound is driving it. Partnering with the surgeon requires a conversation at the beginning, when the referral is made, about goals. After that, she sees her patient monthly and sends progress notes to the surgeon.

Golden collaborates with three orthopedic groups in her area, primarily for knee and hip surgeries, but has also helped patients meet the BMI cutoff before spine-related surgeries. She is helping a lung transplant patient now. She has seen several patients who must meet BMI requirements before starting in vitro fertilization, due to the need for conscious sedation for egg retrieval. She has had a few patients who had to meet a BMI cutoff for nonemergency hernia repair.

 

Insurance Issues

Insurance remains an issue for the pricey medications. “Only about a third of patients are routinely covered with insurance,” Morton said.

However, it’s improving, he said. Golden also finds about a third of private payers cover the medication but tries to use manufacturers’ coupons to help defray the costs (from about $1000 or $1400 to about $500 a month). She has sometimes gotten enough samples to get patients to their BMI goal

Morton consulted for Novo Nordisk, Eli Lilly, Olympus, Teleflex, and Johnson & Johnson.

A version of this article appeared on Medscape.com.

On a recent Sunday morning in Los Angeles, 10 members of Gamblers Anonymous gathered in a park for their regular meeting. After, they shared advice for how physicians can best help patients with problem gambling.

“If a patient talks about financial distress, spouse issues, physical issues, or has blood pressure issues, suspect gambling,” one woman said. Another said, if a physician asks about gambling and the patient says, “Just a little,” chances are that person is an active gambler.

The bottom line: None of the people — who spoke for themselves and not on behalf of Gamblers Anonymous — said they had been asked by their doctors about gambling issues. All said they would welcome such questions.

Gambling is on the rise, and gambling disorder is now recognized in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). The condition is viewed as similar to substance-related disorders in its clinical expression, brain origin, comorbidity, physiology, and treatment.

Primary care physicians (PCPs), more than any of their colleagues, are likely to encounter a patient with an undetected gambling disorder, according to experts, as it often intertwines with physical and mental health concerns. Those conditions bring the patient to their clinicians, although the patients may not link those issues with their gambling. The physicians may not either.

Few PCPs broach the topic. “I would say the majority of physicians do not screen for it,” said Brian K. Unwin, MD, FAAFP, AGSF, a family medicine physician and geriatrician at the Carilion Center for Healthy Aging and professor at the Virginia Tech Carilion School of Medicine, Roanoke.

The clinician who does take steps to screen for the problem is “exceptionally rare,” said Timothy W. Fong, MD, clinical professor of psychiatry at the University of California, Los Angeles (UCLA) and co-director of the UCLA Gambling Studies Program. Launched in 2005, the program conducts research, provides prevention and treatment services, and offers training to healthcare providers and the community.

A Las Vegas physician said colleagues in her area are likewise largely unaware, despite the strong connection with the city and gaming. “I do not think most primary care physicians are routinely asking about gambling,” said Maureen Strohm, MD, president of the Nevada Society of Addiction Medicine. Strohm also directs the addiction medicine fellowship at HCA Sunrise Health GME Consortium at Southern Hills Hospital & Medical Center in Las Vegas and cares for patients with substance abuse issues.

But physicians should look for gambling issues, she said, especially in those with known substance abuse disorders. “We encourage incorporation of gambling as another question in comprehensive assessment of patients, since it’s rarely an isolated issue in our treatment settings,” Strohm said.

 

Gritty Reputation Goes Glam, With No Shortage of Opportunities

Why a rise in gambling? Its reputation, for one thing. “It used to be, if you enjoyed gambling, you were viewed as, what — a person of vice, a person of sin,” Fong said. “That’s completely changed. Engaging in gambling is more accepted — and not just accepted but normalized and even glamorized. In some circles, if you don’t gamble, it’s like, ‘What is wrong with you?’ ”

Opportunities to gamble have increased, including a boom in mobile sports betting. Sports betting online, in person, or both now is legal in 39 states and the District of Columbia. The rate of gambling problems among sports bettors is at least twice as high as that for other gamblers, the National Council on Problem Gambling found. As Fong puts it: “The casino comes to you.”

With the rise in opportunities to bet has come an increase in gambling-related disorders. Statistics vary greatly, but Unwin cites a meta-analysis published in 2023 that found moderate-risk or at-risk gambling affects 2.4% of the adult population and pathologic or problem gambling affects 1.29%. He first noticed problem gambling in young soldiers when he was a military doctor and published on it in 2000.

However, the percentage of people with gambling issues seeking care in PCPs’ offices is much higher, probably from 5% to 16%, research has found. “When you survey people who go to the primary care physicians, the number [with a gambling issue] could be as high as 10%-15% of those going for any medical reason,” Fong said. “Many times, their stories are hidden.”

In November, The Lancet Public Health Commission said it views problem gambling as an expanding public health threat.

 

Seeing the Red Flags

“In a perfect world, it would be great to ask all patients” about gambling issues, Unwin said. A more realistic approach, given clinical workloads, is to be alert to the possibility, especially in patients with depression or substance abuse, which often accompany gambling issues.

Learn to look at patterns, Unwin said. “If a patient has had impulsivity issues, is a young male, has had depression and alcohol issues, let’s look and see what else is going on.” 

Other red flags include anyone with an active mental health problem or with a family history of known gambling problems, Fong said.

Some personality traits are linked with a higher likelihood of gambling issues, including highly impulsive behavior and risk-taking behavior. Many problem gamblers are “not very good with loss aversion. They lose a bunch and shrug it off and go back the next day,” Fong noted.

Often, however, the clues are not obvious. Unwin remembers caring for an older couple, and the wife set up an appointment with him — not to talk about her health but to discuss his gambling. “My husband has spent us into debt,” she said. Unwin recalled being completely surprised.

The situation illustrates the flaw in the stereotypical profile of a problem. “In our mind’s eye, it’s often an older White male who talks loudly, is perhaps counterculture,” Fong said. But he often sees young and older people from all cultures and all economic levels struggling with gambling: “Like other forms of addiction, it cuts across all demographics.”

 

Inside a Gambler’s Brain

Many physicians struggle to understand the attraction of gambling, Fong said. They ask: “How can you be addicted to a behavior? Why can’t you just stop?” He tells them: “If people could do that, they would not have a biological psychiatric disorder,” which is what gambling disorder is.

The urge to gamble can be so strong, “You can’t think of anything else,” Fong said. “It screws up your day.” Gamblers say they’re after the “action,” the euphoric state similar to the highs produced from some drugs. Compared with recreational gamblers, problem gamblers rely more on long-term learning than short-term reward?, and so are less able to learn from their losses in the immediate past, research by Fong and others found.

 

Seeking Treatment

One in five problem gamblers seeks help, and 1 in 25 with a moderate-risk habit do so, Unwin said, citing a 2022 study.

To identify concerning behaviors, physicians can turn to two brief screeners that take just minutes:

• The Brief Biosocial Gambling Screen includes just three questions; a yes to any one suggests a gambling problem.
• The Lie-Bet two-question screener can help determine if a person needs a referral for a gambling problem.

“People tend to be pretty honest with their doctor when asked about gambling,” Fong said. “Even the act of asking is enough to get people to start thinking.”

To meet the DSM-5 criteria for gambling disorder, patients must exhibit at least four or more concerning behaviors in the previous 12 months.

For available treatments, “our toolbox is growing,” Fong said. “Psychotherapy probably works best,” including cognitive-behavioral therapy and relapse prevention approaches. “Twelve-step programs work very well,” Fong added.

Medications used for alcohol use disorder, such as naltrexone, an opioid antagonist, are prescribed for gambling disorder, with some success, he said. Often, developing a positive therapeutic relationship with a person who does not judge them is enough to change behavior, Fong said.

To provide treatment and other services, the UCLA program collaborates with the state Office of Problem Gambling. “We know that at least 70% of our patients who stay in treatment and participate in treatment make really meaningful gains and improvement in some part of their lives,” Fong said. “They do gamble less; they do gamble with less money.

 

Goal: Cold Turkey or Harm Reduction?

Fong tells gamblers seeking help: “My goal is to reduce the harm related to your gambling.” In working with patients, he identifies forms that are most problematic and those less likely to cause problems. For some, sports betting may be an issue, but going to Las Vegas a few times a year to play the slots may not generate harm for them. Many patients still gamble, he said, but have a better quality of life if they focus on health and wellness.

“Abstinence is just one domain,” Fong said. The others — home, health, self-care, a sense of purpose, community — are important, too. He helps patients to focus on those.”

Of all the addictions, gambling is one physicians are largely unaware of, Fong said. “And the patients have something that can be treated.”

Unwin, Strohm, and Fong reported no relevant financial disclosures. Physicians can attend open meetings of Gamblers Anonymous to find out more. Members of the group are available to speak to clinicians.

A version of this article appeared on Medscape.com.

On a recent Sunday morning in Los Angeles, 10 members of Gamblers Anonymous gathered in a park for their regular meeting. After, they shared advice for how physicians can best help patients with problem gambling.

“If a patient talks about financial distress, spouse issues, physical issues, or has blood pressure issues, suspect gambling,” one woman said. Another said, if a physician asks about gambling and the patient says, “Just a little,” chances are that person is an active gambler.

The bottom line: None of the people — who spoke for themselves and not on behalf of Gamblers Anonymous — said they had been asked by their doctors about gambling issues. All said they would welcome such questions.

Gambling is on the rise, and gambling disorder is now recognized in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). The condition is viewed as similar to substance-related disorders in its clinical expression, brain origin, comorbidity, physiology, and treatment.

Primary care physicians (PCPs), more than any of their colleagues, are likely to encounter a patient with an undetected gambling disorder, according to experts, as it often intertwines with physical and mental health concerns. Those conditions bring the patient to their clinicians, although the patients may not link those issues with their gambling. The physicians may not either.

Few PCPs broach the topic. “I would say the majority of physicians do not screen for it,” said Brian K. Unwin, MD, FAAFP, AGSF, a family medicine physician and geriatrician at the Carilion Center for Healthy Aging and professor at the Virginia Tech Carilion School of Medicine, Roanoke.

The clinician who does take steps to screen for the problem is “exceptionally rare,” said Timothy W. Fong, MD, clinical professor of psychiatry at the University of California, Los Angeles (UCLA) and co-director of the UCLA Gambling Studies Program. Launched in 2005, the program conducts research, provides prevention and treatment services, and offers training to healthcare providers and the community.

A Las Vegas physician said colleagues in her area are likewise largely unaware, despite the strong connection with the city and gaming. “I do not think most primary care physicians are routinely asking about gambling,” said Maureen Strohm, MD, president of the Nevada Society of Addiction Medicine. Strohm also directs the addiction medicine fellowship at HCA Sunrise Health GME Consortium at Southern Hills Hospital & Medical Center in Las Vegas and cares for patients with substance abuse issues.

But physicians should look for gambling issues, she said, especially in those with known substance abuse disorders. “We encourage incorporation of gambling as another question in comprehensive assessment of patients, since it’s rarely an isolated issue in our treatment settings,” Strohm said.

 

Gritty Reputation Goes Glam, With No Shortage of Opportunities

Why a rise in gambling? Its reputation, for one thing. “It used to be, if you enjoyed gambling, you were viewed as, what — a person of vice, a person of sin,” Fong said. “That’s completely changed. Engaging in gambling is more accepted — and not just accepted but normalized and even glamorized. In some circles, if you don’t gamble, it’s like, ‘What is wrong with you?’ ”

Opportunities to gamble have increased, including a boom in mobile sports betting. Sports betting online, in person, or both now is legal in 39 states and the District of Columbia. The rate of gambling problems among sports bettors is at least twice as high as that for other gamblers, the National Council on Problem Gambling found. As Fong puts it: “The casino comes to you.”

With the rise in opportunities to bet has come an increase in gambling-related disorders. Statistics vary greatly, but Unwin cites a meta-analysis published in 2023 that found moderate-risk or at-risk gambling affects 2.4% of the adult population and pathologic or problem gambling affects 1.29%. He first noticed problem gambling in young soldiers when he was a military doctor and published on it in 2000.

However, the percentage of people with gambling issues seeking care in PCPs’ offices is much higher, probably from 5% to 16%, research has found. “When you survey people who go to the primary care physicians, the number [with a gambling issue] could be as high as 10%-15% of those going for any medical reason,” Fong said. “Many times, their stories are hidden.”

In November, The Lancet Public Health Commission said it views problem gambling as an expanding public health threat.

 

Seeing the Red Flags

“In a perfect world, it would be great to ask all patients” about gambling issues, Unwin said. A more realistic approach, given clinical workloads, is to be alert to the possibility, especially in patients with depression or substance abuse, which often accompany gambling issues.

Learn to look at patterns, Unwin said. “If a patient has had impulsivity issues, is a young male, has had depression and alcohol issues, let’s look and see what else is going on.” 

Other red flags include anyone with an active mental health problem or with a family history of known gambling problems, Fong said.

Some personality traits are linked with a higher likelihood of gambling issues, including highly impulsive behavior and risk-taking behavior. Many problem gamblers are “not very good with loss aversion. They lose a bunch and shrug it off and go back the next day,” Fong noted.

Often, however, the clues are not obvious. Unwin remembers caring for an older couple, and the wife set up an appointment with him — not to talk about her health but to discuss his gambling. “My husband has spent us into debt,” she said. Unwin recalled being completely surprised.

The situation illustrates the flaw in the stereotypical profile of a problem. “In our mind’s eye, it’s often an older White male who talks loudly, is perhaps counterculture,” Fong said. But he often sees young and older people from all cultures and all economic levels struggling with gambling: “Like other forms of addiction, it cuts across all demographics.”

 

Inside a Gambler’s Brain

Many physicians struggle to understand the attraction of gambling, Fong said. They ask: “How can you be addicted to a behavior? Why can’t you just stop?” He tells them: “If people could do that, they would not have a biological psychiatric disorder,” which is what gambling disorder is.

The urge to gamble can be so strong, “You can’t think of anything else,” Fong said. “It screws up your day.” Gamblers say they’re after the “action,” the euphoric state similar to the highs produced from some drugs. Compared with recreational gamblers, problem gamblers rely more on long-term learning than short-term reward?, and so are less able to learn from their losses in the immediate past, research by Fong and others found.

 

Seeking Treatment

One in five problem gamblers seeks help, and 1 in 25 with a moderate-risk habit do so, Unwin said, citing a 2022 study.

To identify concerning behaviors, physicians can turn to two brief screeners that take just minutes:

• The Brief Biosocial Gambling Screen includes just three questions; a yes to any one suggests a gambling problem.
• The Lie-Bet two-question screener can help determine if a person needs a referral for a gambling problem.

“People tend to be pretty honest with their doctor when asked about gambling,” Fong said. “Even the act of asking is enough to get people to start thinking.”

To meet the DSM-5 criteria for gambling disorder, patients must exhibit at least four or more concerning behaviors in the previous 12 months.

For available treatments, “our toolbox is growing,” Fong said. “Psychotherapy probably works best,” including cognitive-behavioral therapy and relapse prevention approaches. “Twelve-step programs work very well,” Fong added.

Medications used for alcohol use disorder, such as naltrexone, an opioid antagonist, are prescribed for gambling disorder, with some success, he said. Often, developing a positive therapeutic relationship with a person who does not judge them is enough to change behavior, Fong said.

To provide treatment and other services, the UCLA program collaborates with the state Office of Problem Gambling. “We know that at least 70% of our patients who stay in treatment and participate in treatment make really meaningful gains and improvement in some part of their lives,” Fong said. “They do gamble less; they do gamble with less money.

 

Goal: Cold Turkey or Harm Reduction?

Fong tells gamblers seeking help: “My goal is to reduce the harm related to your gambling.” In working with patients, he identifies forms that are most problematic and those less likely to cause problems. For some, sports betting may be an issue, but going to Las Vegas a few times a year to play the slots may not generate harm for them. Many patients still gamble, he said, but have a better quality of life if they focus on health and wellness.

“Abstinence is just one domain,” Fong said. The others — home, health, self-care, a sense of purpose, community — are important, too. He helps patients to focus on those.”

Of all the addictions, gambling is one physicians are largely unaware of, Fong said. “And the patients have something that can be treated.”

Unwin, Strohm, and Fong reported no relevant financial disclosures. Physicians can attend open meetings of Gamblers Anonymous to find out more. Members of the group are available to speak to clinicians.

A version of this article appeared on Medscape.com.

On a recent Sunday morning in Los Angeles, 10 members of Gamblers Anonymous gathered in a park for their regular meeting. After, they shared advice for how physicians can best help patients with problem gambling.

“If a patient talks about financial distress, spouse issues, physical issues, or has blood pressure issues, suspect gambling,” one woman said. Another said, if a physician asks about gambling and the patient says, “Just a little,” chances are that person is an active gambler.

The bottom line: None of the people — who spoke for themselves and not on behalf of Gamblers Anonymous — said they had been asked by their doctors about gambling issues. All said they would welcome such questions.

Gambling is on the rise, and gambling disorder is now recognized in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). The condition is viewed as similar to substance-related disorders in its clinical expression, brain origin, comorbidity, physiology, and treatment.

Primary care physicians (PCPs), more than any of their colleagues, are likely to encounter a patient with an undetected gambling disorder, according to experts, as it often intertwines with physical and mental health concerns. Those conditions bring the patient to their clinicians, although the patients may not link those issues with their gambling. The physicians may not either.

Few PCPs broach the topic. “I would say the majority of physicians do not screen for it,” said Brian K. Unwin, MD, FAAFP, AGSF, a family medicine physician and geriatrician at the Carilion Center for Healthy Aging and professor at the Virginia Tech Carilion School of Medicine, Roanoke.

The clinician who does take steps to screen for the problem is “exceptionally rare,” said Timothy W. Fong, MD, clinical professor of psychiatry at the University of California, Los Angeles (UCLA) and co-director of the UCLA Gambling Studies Program. Launched in 2005, the program conducts research, provides prevention and treatment services, and offers training to healthcare providers and the community.

A Las Vegas physician said colleagues in her area are likewise largely unaware, despite the strong connection with the city and gaming. “I do not think most primary care physicians are routinely asking about gambling,” said Maureen Strohm, MD, president of the Nevada Society of Addiction Medicine. Strohm also directs the addiction medicine fellowship at HCA Sunrise Health GME Consortium at Southern Hills Hospital & Medical Center in Las Vegas and cares for patients with substance abuse issues.

But physicians should look for gambling issues, she said, especially in those with known substance abuse disorders. “We encourage incorporation of gambling as another question in comprehensive assessment of patients, since it’s rarely an isolated issue in our treatment settings,” Strohm said.

 

Gritty Reputation Goes Glam, With No Shortage of Opportunities

Why a rise in gambling? Its reputation, for one thing. “It used to be, if you enjoyed gambling, you were viewed as, what — a person of vice, a person of sin,” Fong said. “That’s completely changed. Engaging in gambling is more accepted — and not just accepted but normalized and even glamorized. In some circles, if you don’t gamble, it’s like, ‘What is wrong with you?’ ”

Opportunities to gamble have increased, including a boom in mobile sports betting. Sports betting online, in person, or both now is legal in 39 states and the District of Columbia. The rate of gambling problems among sports bettors is at least twice as high as that for other gamblers, the National Council on Problem Gambling found. As Fong puts it: “The casino comes to you.”

With the rise in opportunities to bet has come an increase in gambling-related disorders. Statistics vary greatly, but Unwin cites a meta-analysis published in 2023 that found moderate-risk or at-risk gambling affects 2.4% of the adult population and pathologic or problem gambling affects 1.29%. He first noticed problem gambling in young soldiers when he was a military doctor and published on it in 2000.

However, the percentage of people with gambling issues seeking care in PCPs’ offices is much higher, probably from 5% to 16%, research has found. “When you survey people who go to the primary care physicians, the number [with a gambling issue] could be as high as 10%-15% of those going for any medical reason,” Fong said. “Many times, their stories are hidden.”

In November, The Lancet Public Health Commission said it views problem gambling as an expanding public health threat.

 

Seeing the Red Flags

“In a perfect world, it would be great to ask all patients” about gambling issues, Unwin said. A more realistic approach, given clinical workloads, is to be alert to the possibility, especially in patients with depression or substance abuse, which often accompany gambling issues.

Learn to look at patterns, Unwin said. “If a patient has had impulsivity issues, is a young male, has had depression and alcohol issues, let’s look and see what else is going on.” 

Other red flags include anyone with an active mental health problem or with a family history of known gambling problems, Fong said.

Some personality traits are linked with a higher likelihood of gambling issues, including highly impulsive behavior and risk-taking behavior. Many problem gamblers are “not very good with loss aversion. They lose a bunch and shrug it off and go back the next day,” Fong noted.

Often, however, the clues are not obvious. Unwin remembers caring for an older couple, and the wife set up an appointment with him — not to talk about her health but to discuss his gambling. “My husband has spent us into debt,” she said. Unwin recalled being completely surprised.

The situation illustrates the flaw in the stereotypical profile of a problem. “In our mind’s eye, it’s often an older White male who talks loudly, is perhaps counterculture,” Fong said. But he often sees young and older people from all cultures and all economic levels struggling with gambling: “Like other forms of addiction, it cuts across all demographics.”

 

Inside a Gambler’s Brain

Many physicians struggle to understand the attraction of gambling, Fong said. They ask: “How can you be addicted to a behavior? Why can’t you just stop?” He tells them: “If people could do that, they would not have a biological psychiatric disorder,” which is what gambling disorder is.

The urge to gamble can be so strong, “You can’t think of anything else,” Fong said. “It screws up your day.” Gamblers say they’re after the “action,” the euphoric state similar to the highs produced from some drugs. Compared with recreational gamblers, problem gamblers rely more on long-term learning than short-term reward?, and so are less able to learn from their losses in the immediate past, research by Fong and others found.

 

Seeking Treatment

One in five problem gamblers seeks help, and 1 in 25 with a moderate-risk habit do so, Unwin said, citing a 2022 study.

To identify concerning behaviors, physicians can turn to two brief screeners that take just minutes:

• The Brief Biosocial Gambling Screen includes just three questions; a yes to any one suggests a gambling problem.
• The Lie-Bet two-question screener can help determine if a person needs a referral for a gambling problem.

“People tend to be pretty honest with their doctor when asked about gambling,” Fong said. “Even the act of asking is enough to get people to start thinking.”

To meet the DSM-5 criteria for gambling disorder, patients must exhibit at least four or more concerning behaviors in the previous 12 months.

For available treatments, “our toolbox is growing,” Fong said. “Psychotherapy probably works best,” including cognitive-behavioral therapy and relapse prevention approaches. “Twelve-step programs work very well,” Fong added.

Medications used for alcohol use disorder, such as naltrexone, an opioid antagonist, are prescribed for gambling disorder, with some success, he said. Often, developing a positive therapeutic relationship with a person who does not judge them is enough to change behavior, Fong said.

To provide treatment and other services, the UCLA program collaborates with the state Office of Problem Gambling. “We know that at least 70% of our patients who stay in treatment and participate in treatment make really meaningful gains and improvement in some part of their lives,” Fong said. “They do gamble less; they do gamble with less money.

 

Goal: Cold Turkey or Harm Reduction?

Fong tells gamblers seeking help: “My goal is to reduce the harm related to your gambling.” In working with patients, he identifies forms that are most problematic and those less likely to cause problems. For some, sports betting may be an issue, but going to Las Vegas a few times a year to play the slots may not generate harm for them. Many patients still gamble, he said, but have a better quality of life if they focus on health and wellness.

“Abstinence is just one domain,” Fong said. The others — home, health, self-care, a sense of purpose, community — are important, too. He helps patients to focus on those.”

Of all the addictions, gambling is one physicians are largely unaware of, Fong said. “And the patients have something that can be treated.”

Unwin, Strohm, and Fong reported no relevant financial disclosures. Physicians can attend open meetings of Gamblers Anonymous to find out more. Members of the group are available to speak to clinicians.

A version of this article appeared on Medscape.com.

The updated COVID vaccines for 2024-2025 are officially here, designed to target the latest variants and offer robust protection — but getting Americans to roll up their sleeves could prove harder than ever. With COVID cases on the decline, many people feel the urgency has passed.

As of December 2, the CDC reports that COVID test positivity remains low, rising slightly to 4.5% for the week ending November 23, compared with 4.2% the previous week. That’s a far cry from the early days of 2022, when positivity rates soared above 30%. Emergency room visits for COVID now make up just 0.5%, and deaths are down to 0.8% of total weekly fatalities, compared to 1% the previous week.

This steady improvement in the numbers may explain why a recent Pew Research Center survey revealed that 6 in 10 US adults have no plans to get the updated vaccine this year.

As of December 2, according to the CDC, just 19.7% of the US adult population and 9.4% of children had gotten the updated vaccine. The age group most likely? Adults ages 65 and older, with 41.6% getting the updated shot.

Despite the good news about declining cases, our pandemic history suggests a pre-holiday increase is likely. On November 20, the CDC warned it expects levels of both COVID and RSV (respiratory syncytial virus) to rise in the coming weeks — the familiar post-Thanksgiving, pre-Christmas, and Hanukkah increase.

Here’s what to know about the 2024-2025 vaccines — what’s available, how the updated versions are tested, how well each protects you, side effects and other safety information, the best time to get them, and where.



 

What’s Available?

Three updated vaccines, which work two different ways, are authorized or licensed by the FDA for the 2024-2025 season:

Novavax. A protein subunit vaccine, Novavax is authorized for emergency use by the FDA in people ages 12 and older. The vaccine makes a protein that mimics the SARS-CoV-2 virus’ version of the spike protein and combines it with an adjuvant or “booster” to stimulate a protective immune response. This year’s version targets the JN.1 variant.

Pfizer/BioNTech. Its Comirnaty is a fully licensed vaccine for people ages 12 and older. Its mechanism of action is by messenger RNA (mRNA). It works by instructing cells to produce viral proteins, triggering an immune response. Pfizer’s COVID vaccine is authorized for emergency use in children ages 6 months to 11 years. This year’s version targets KP.2.

Moderna. Its Spikevax is a fully licensed vaccine for people ages 12 and older. It is also an mRNA vaccine. Moderna’s COVID-19 vaccine is authorized for emergency use in children ages 6 months to 11 years. This year’s version targets KP.2.

 

How Effective Are They?

Before being approved for this year’s use, each company had to show its updated vaccine is effective against the currently circulating variants. For the 2 weeks ending November 23, KP.3.1.1 and XEC, from the Omicron lineage, made up the majority of cases, according to CDC data.

How do the vaccine makers know their updated vaccines are targeting the circulating variants? The companies use “pre-clinical” data, which means the updated versions have not yet been tested in people but in other ways, such as animal studies. But they do have to prove to the FDA that their updated vaccine can neutralize the circulating variants.

Companies continue to monitor their updated vaccines as new variants appear. Later in the season, there will be more specific information about how well each vaccine protects in people after tracking real-world data.

 

What About Side Effects?

The CDC lists comparable side effects for both mRNA and protein COVID vaccines, including pain and soreness from the needle, fatigue, headache, muscle pain joint pain, chills, fever, nausea, and vomiting.

Severe allergic reactions are rare, the CDC says, but cautions to be alert for low blood pressure, swelling of the lips, tongue, or throat, or difficulty breathing.

 

Which One Is Best?

“I consider the three currently available COVID vaccines — Pfizer, Moderna, and Novavax — interchangeable,’’ said Scott Roberts, MD, an infectious diseases specialist and assistant professor of medicine at Yale School of Medicine in New Haven, Connecticut. “There have not been head-to-head studies, and the initial vaccine studies for each were performed at different phases of the pandemic, so we do not have great data to guide which one is better than another.”

He does point out the different mechanisms of action, which may make a difference in people’s choice of vaccines. “So if someone has a reaction to one of them, they can switch to a different brand.”

 

Best Time to Get It?

“We have consistently seen COVID rates rise quite significantly in the winter season, especially around the holidays. So if anyone is on the fence and hasn’t gotten the updated vaccine yet, now is a great time to get it to maximize immunity for the holidays,” he said.

What’s next? In late October, the CDC recommended a second dose of the 2024-2025 vaccine 6 months after the first one for those age 65 and above and those 6 months old and older who are moderately or severely immunocompromised.

Now, while it’s tempting to think rates are down and will continue to drop steadily, Roberts reminds people that pandemic history suggests otherwise.

 

Coverage

Most people can get COVID-19 vaccines at no cost through their private health insurance, Medicaid, or Medicare. For the uninsured, there’s also the Vaccines for Children (VFC) program or access through state and local health departments and some health centers. Find details on the CDC website.

A version of this article first appeared on WebMD.

The updated COVID vaccines for 2024-2025 are officially here, designed to target the latest variants and offer robust protection — but getting Americans to roll up their sleeves could prove harder than ever. With COVID cases on the decline, many people feel the urgency has passed.

As of December 2, the CDC reports that COVID test positivity remains low, rising slightly to 4.5% for the week ending November 23, compared with 4.2% the previous week. That’s a far cry from the early days of 2022, when positivity rates soared above 30%. Emergency room visits for COVID now make up just 0.5%, and deaths are down to 0.8% of total weekly fatalities, compared to 1% the previous week.

This steady improvement in the numbers may explain why a recent Pew Research Center survey revealed that 6 in 10 US adults have no plans to get the updated vaccine this year.

As of December 2, according to the CDC, just 19.7% of the US adult population and 9.4% of children had gotten the updated vaccine. The age group most likely? Adults ages 65 and older, with 41.6% getting the updated shot.

Despite the good news about declining cases, our pandemic history suggests a pre-holiday increase is likely. On November 20, the CDC warned it expects levels of both COVID and RSV (respiratory syncytial virus) to rise in the coming weeks — the familiar post-Thanksgiving, pre-Christmas, and Hanukkah increase.

Here’s what to know about the 2024-2025 vaccines — what’s available, how the updated versions are tested, how well each protects you, side effects and other safety information, the best time to get them, and where.



 

What’s Available?

Three updated vaccines, which work two different ways, are authorized or licensed by the FDA for the 2024-2025 season:

Novavax. A protein subunit vaccine, Novavax is authorized for emergency use by the FDA in people ages 12 and older. The vaccine makes a protein that mimics the SARS-CoV-2 virus’ version of the spike protein and combines it with an adjuvant or “booster” to stimulate a protective immune response. This year’s version targets the JN.1 variant.

Pfizer/BioNTech. Its Comirnaty is a fully licensed vaccine for people ages 12 and older. Its mechanism of action is by messenger RNA (mRNA). It works by instructing cells to produce viral proteins, triggering an immune response. Pfizer’s COVID vaccine is authorized for emergency use in children ages 6 months to 11 years. This year’s version targets KP.2.

Moderna. Its Spikevax is a fully licensed vaccine for people ages 12 and older. It is also an mRNA vaccine. Moderna’s COVID-19 vaccine is authorized for emergency use in children ages 6 months to 11 years. This year’s version targets KP.2.

 

How Effective Are They?

Before being approved for this year’s use, each company had to show its updated vaccine is effective against the currently circulating variants. For the 2 weeks ending November 23, KP.3.1.1 and XEC, from the Omicron lineage, made up the majority of cases, according to CDC data.

How do the vaccine makers know their updated vaccines are targeting the circulating variants? The companies use “pre-clinical” data, which means the updated versions have not yet been tested in people but in other ways, such as animal studies. But they do have to prove to the FDA that their updated vaccine can neutralize the circulating variants.

Companies continue to monitor their updated vaccines as new variants appear. Later in the season, there will be more specific information about how well each vaccine protects in people after tracking real-world data.

 

What About Side Effects?

The CDC lists comparable side effects for both mRNA and protein COVID vaccines, including pain and soreness from the needle, fatigue, headache, muscle pain joint pain, chills, fever, nausea, and vomiting.

Severe allergic reactions are rare, the CDC says, but cautions to be alert for low blood pressure, swelling of the lips, tongue, or throat, or difficulty breathing.

 

Which One Is Best?

“I consider the three currently available COVID vaccines — Pfizer, Moderna, and Novavax — interchangeable,’’ said Scott Roberts, MD, an infectious diseases specialist and assistant professor of medicine at Yale School of Medicine in New Haven, Connecticut. “There have not been head-to-head studies, and the initial vaccine studies for each were performed at different phases of the pandemic, so we do not have great data to guide which one is better than another.”

He does point out the different mechanisms of action, which may make a difference in people’s choice of vaccines. “So if someone has a reaction to one of them, they can switch to a different brand.”

 

Best Time to Get It?

“We have consistently seen COVID rates rise quite significantly in the winter season, especially around the holidays. So if anyone is on the fence and hasn’t gotten the updated vaccine yet, now is a great time to get it to maximize immunity for the holidays,” he said.

What’s next? In late October, the CDC recommended a second dose of the 2024-2025 vaccine 6 months after the first one for those age 65 and above and those 6 months old and older who are moderately or severely immunocompromised.

Now, while it’s tempting to think rates are down and will continue to drop steadily, Roberts reminds people that pandemic history suggests otherwise.

 

Coverage

Most people can get COVID-19 vaccines at no cost through their private health insurance, Medicaid, or Medicare. For the uninsured, there’s also the Vaccines for Children (VFC) program or access through state and local health departments and some health centers. Find details on the CDC website.

A version of this article first appeared on WebMD.

The updated COVID vaccines for 2024-2025 are officially here, designed to target the latest variants and offer robust protection — but getting Americans to roll up their sleeves could prove harder than ever. With COVID cases on the decline, many people feel the urgency has passed.

As of December 2, the CDC reports that COVID test positivity remains low, rising slightly to 4.5% for the week ending November 23, compared with 4.2% the previous week. That’s a far cry from the early days of 2022, when positivity rates soared above 30%. Emergency room visits for COVID now make up just 0.5%, and deaths are down to 0.8% of total weekly fatalities, compared to 1% the previous week.

This steady improvement in the numbers may explain why a recent Pew Research Center survey revealed that 6 in 10 US adults have no plans to get the updated vaccine this year.

As of December 2, according to the CDC, just 19.7% of the US adult population and 9.4% of children had gotten the updated vaccine. The age group most likely? Adults ages 65 and older, with 41.6% getting the updated shot.

Despite the good news about declining cases, our pandemic history suggests a pre-holiday increase is likely. On November 20, the CDC warned it expects levels of both COVID and RSV (respiratory syncytial virus) to rise in the coming weeks — the familiar post-Thanksgiving, pre-Christmas, and Hanukkah increase.

Here’s what to know about the 2024-2025 vaccines — what’s available, how the updated versions are tested, how well each protects you, side effects and other safety information, the best time to get them, and where.



 

What’s Available?

Three updated vaccines, which work two different ways, are authorized or licensed by the FDA for the 2024-2025 season:

Novavax. A protein subunit vaccine, Novavax is authorized for emergency use by the FDA in people ages 12 and older. The vaccine makes a protein that mimics the SARS-CoV-2 virus’ version of the spike protein and combines it with an adjuvant or “booster” to stimulate a protective immune response. This year’s version targets the JN.1 variant.

Pfizer/BioNTech. Its Comirnaty is a fully licensed vaccine for people ages 12 and older. Its mechanism of action is by messenger RNA (mRNA). It works by instructing cells to produce viral proteins, triggering an immune response. Pfizer’s COVID vaccine is authorized for emergency use in children ages 6 months to 11 years. This year’s version targets KP.2.

Moderna. Its Spikevax is a fully licensed vaccine for people ages 12 and older. It is also an mRNA vaccine. Moderna’s COVID-19 vaccine is authorized for emergency use in children ages 6 months to 11 years. This year’s version targets KP.2.

 

How Effective Are They?

Before being approved for this year’s use, each company had to show its updated vaccine is effective against the currently circulating variants. For the 2 weeks ending November 23, KP.3.1.1 and XEC, from the Omicron lineage, made up the majority of cases, according to CDC data.

How do the vaccine makers know their updated vaccines are targeting the circulating variants? The companies use “pre-clinical” data, which means the updated versions have not yet been tested in people but in other ways, such as animal studies. But they do have to prove to the FDA that their updated vaccine can neutralize the circulating variants.

Companies continue to monitor their updated vaccines as new variants appear. Later in the season, there will be more specific information about how well each vaccine protects in people after tracking real-world data.

 

What About Side Effects?

The CDC lists comparable side effects for both mRNA and protein COVID vaccines, including pain and soreness from the needle, fatigue, headache, muscle pain joint pain, chills, fever, nausea, and vomiting.

Severe allergic reactions are rare, the CDC says, but cautions to be alert for low blood pressure, swelling of the lips, tongue, or throat, or difficulty breathing.

 

Which One Is Best?

“I consider the three currently available COVID vaccines — Pfizer, Moderna, and Novavax — interchangeable,’’ said Scott Roberts, MD, an infectious diseases specialist and assistant professor of medicine at Yale School of Medicine in New Haven, Connecticut. “There have not been head-to-head studies, and the initial vaccine studies for each were performed at different phases of the pandemic, so we do not have great data to guide which one is better than another.”

He does point out the different mechanisms of action, which may make a difference in people’s choice of vaccines. “So if someone has a reaction to one of them, they can switch to a different brand.”

 

Best Time to Get It?

“We have consistently seen COVID rates rise quite significantly in the winter season, especially around the holidays. So if anyone is on the fence and hasn’t gotten the updated vaccine yet, now is a great time to get it to maximize immunity for the holidays,” he said.

What’s next? In late October, the CDC recommended a second dose of the 2024-2025 vaccine 6 months after the first one for those age 65 and above and those 6 months old and older who are moderately or severely immunocompromised.

Now, while it’s tempting to think rates are down and will continue to drop steadily, Roberts reminds people that pandemic history suggests otherwise.

 

Coverage

Most people can get COVID-19 vaccines at no cost through their private health insurance, Medicaid, or Medicare. For the uninsured, there’s also the Vaccines for Children (VFC) program or access through state and local health departments and some health centers. Find details on the CDC website.

A version of this article first appeared on WebMD.

The question may seem simple: Could paying for weight loss medications — especially the pricey glucagon-like peptide 1 receptor agonists (GLP-1s), tirzepatide (Zepbound) and semaglutide (Wegovy) — be more cost-effective than paying for obesity care and the complications of obesity, such as cardiovascular disease and diabetes?

It’s a question that’s getting an increased amount of attention.

And for good reason — more than two in five US adults have obesity, according to the Centers for Disease Control and Prevention, and costs to treat obesity, in 2019 dollars, approached $173 billion, including productivity losses. Adults with obesity have annual healthcare costs of $1861 more than those at healthier weights.

Among recent developments:

• A proposed new rule, announced on November 26 by the Biden administration, expands coverage of anti-obesity medication for Americans who have Medicare and Medicaid. If it takes effect, an estimated 3.4 million Medicare recipients and about 4 million adult Medicaid enrollees could get access to the medications.
• As Medicare coverage goes, private insurers often follow. Observers predict that if the Centers for Medicare & Medicaid Services (CMS) covers anti-obesity drugs, more private employers may soon do the same. Recently, however, some private plans have done the opposite and dropped coverage of the pricey GLP-1s, which can cost $1000 a month or more out-of-pocket, citing excess costs for their company.
• Among the analyses about the value of weight loss on healthcare cost savings is a report published on December 5 in JAMA Network Open. Emory University experts looked at privately insured adults and adult Medicare beneficiaries with a body mass index (BMI) of ≥ 25 (classified as overweight). The conclusion: Projected annual savings from weight loss among US adults with obesity were substantial for both employee-based insurance and Medicare recipients.
• Besides helping obesity and obesity-related conditions, access to GLP-1s could have a favorable effect on productivity, others claim. That’s one focus of a 5-year partnership between the University of Manchester in England, and Eli Lilly and Company. Called SURMOUNT-REAL UK, the study will evaluate the effectiveness of tirzepatide in weight loss, diabetes prevention, and prevention of obesity-related complications in adults with obesity. It also aims to look at changes in health-related quality of life with weight loss and with changes in employment status and sick days.

CMS Proposal

In a statement announcing the proposal for Medicare and Medicaid to offer weight loss drugs, the White House noted that “tens of millions of Americans struggle with obesity” but that currently Medicare only covers the anti-obesity medications for certain conditions such as diabetes. The new proposal would expand that access to those with obesity. As of August, just 13 states cover GLP-1s in Medicaid programs, and North Carolina was the latest to do so.

Organizations advocating for health equity and recognition that obesity is a chronic disease came out in strong support of the proposal.

Kenneth E. Thorpe, PhD, a health policy expert at Emory University in Atlanta, who coauthored the recent analysis finding that weight loss offsets healthcare costs on an individual basis, told this news organization: “If finalized, this broad new coverage [by Medicare and Medicaid] would have a profound impact on the ability of Americans to access these novel medications that could significantly reduce obesity-related healthcare spending and improve overall health.”

The proposal “is modernizing the coverage of Medicare and Medicaid for obesity treatment,” agreed John Cawley, PhD, professor of economics and public policy at Cornell University in Ithaca, New York, who has researched the direct medical costs of obesity in the United States. “In this HHS rule, they talk about the scientific and medical consensus that having obesity is a chronic condition.”

The proposal requires a 60-day comment period that ends January 27, 2025, taking the timeline into the beginning of the Trump administration. Cawley and others pointed out that Trump’s pick for Health and Human Services Secretary, Robert F. Kennedy Jr, has been an outspoken opponent of the anti-obesity medicines, suggesting instead that Americans simply eat better.

 

Expert Analyses: Emory, Cornell, Southern California

So would paying for the pricey GLP-1s be smart in the long term? Analyses don’t agree.

Weight loss among those with obesity produces healthcare cost savings, said Thorpe and Peter Joski, MSPH, an associate research professor at Emory University. The two compared annual healthcare spending among privately insured adults and adult Medicare beneficiaries with a BMI of ≥ 25, using data from the Medical Expenditure Panel Survey — Household Component from April 1 to June 20, 2024.

The researchers looked at 3774 adults insured with Medicare and 13,435 with employer-sponsored insurance. Overall, those with private insurance with a weight loss of 5% spent an estimated average of $670 less on healthcare. Those with a weight loss of 25% spent an estimated $2849 less on healthcare. Among those with Medicare who had one or more comorbidities, a 5% weight loss reduced spending by $1262 on average; a 25% loss reduced it by an estimated $5442, or 31%.

Thorpe called the savings substantial. In an email interview, Thorpe said, “So yes, weight loss for people living with obesity does lower healthcare costs, as my research shows, but it also lowers other costs as well.”

These include costs associated with disability, workers’ compensation, presenteeism/absenteeism, and everyday costs, he said. He contends that “those other costs should factor into decisions about preventing and treating obesity of payors and policymakers and enhance the case for cost-effectiveness of treating obesity.”

Other research suggests it’s important to target the use of the anti-obesity medications to the BMI range that would get the most benefit. For people just barely above the BMI threshold of 30, no cost savings are expected, Cawley found in his research. But he has found substantial cost reduction if the BMI was 35-40.

However, as Cawley pointed out, as the drugs get cheaper and more options become available, the entire scenario is expected to shift.

 

The Congressional Budget Office View

In October, the nonpartisan Congressional Budget Office issued a report, “How Would Authorizing Medicare to Cover Anti-Obesity Medications Affect the Federal Budget?” Among the conclusions: Covering the anti-obesity medications would increase federal spending, on net, by about $35 billion from 2026 to 2034. Total direct federal costs of covering the medication would increase from $1.6 billion in 2026 to $7.1 billion in 2034. And it said total savings from improved health of the beneficiaries would be small, less than $50 million in 2026 and rising to $1 billion in 2034.

Covering the medications would cost $5600 per user in 2026, then down to $4300 in 2034. The offset of savings per user would be about $50 in 2026, then $650 in 2034.

 

Expert Analysis: USC Schaeffer Center

“The costs offsets come over time,” said Alison Sexton Ward, PhD, an economist at the University of Southern California’s Leonard D. Schaeffer Center, Los Angeles, and an expert on the topic. “If we look at the average annual medical cost over a lifetime, we do see cost offsets there.”

However, treating obesity means people will live longer, “and living longer costs more,” she said.

She took issue with some of the calculations in the CBO report, such as not considering the effect of semaglutide’s patent expiring in 2033.

In a white paper published in April 2023, Sexton Ward and her coauthors modeled potential social benefits and medical cost offsets from granting access to the newer weight loss drugs. The cumulative social benefits of providing coverage over the next decade would reach nearly $1 trillion, they said. Benefits would increase if private insurance expanded coverage. “In the first 10 years alone, covering weight loss therapies would save Medicare $175 billion-$245 billion, depending on whether private insurance joins Medicare in providing coverage for younger populations.”

While much focus is on Medicare coverage, Sexton Ward and others pointed out the need to expand coverage to younger ages, with the aim of preventing or delaying obesity-related complications.

 

Lilly UK Trial

A spokesperson for Lilly declined to comment further on the UK study, explaining that the study was just launching.

Besides tracking weight loss, researchers will evaluate the effect of the weight loss on sick days from work and employment. Obesity is shown to affect a person’s ability to work, leading to more absenteeism, so treating the obesity may improve productivity.

 

Beyond Health: The Value of Weight Loss

“I love the idea of studying whether access to obesity medications helps people stay employed and do their job,” said Cristy Gallagher, associate director of Research and Policy at STOP Obesity Alliance at the Milken Institute School of Public Health, George Washington University, Washington, DC. The alliance includes more than 50 organizations advocating for adult obesity treatment.

“One of our big arguments is [that] access to care, and to obesity care, will also help other conditions — comorbidities like heart disease and diabetes.”

However, access to the anti-obesity medications, by itself, is not enough, Gallagher said. Other components, such as intensive behavioral therapy and guidance about diet and exercise, are needed, she said. So, too, for those who need it, is access to bariatric surgery, she said. And medication access should include other options besides the GLP-1s, she said. “Not every medication is right for everybody.”

Cawley, Gallagher, Thorpe, and Sexton Ward had no disclosures.
 

A version of this article appeared on Medscape.com.

The question may seem simple: Could paying for weight loss medications — especially the pricey glucagon-like peptide 1 receptor agonists (GLP-1s), tirzepatide (Zepbound) and semaglutide (Wegovy) — be more cost-effective than paying for obesity care and the complications of obesity, such as cardiovascular disease and diabetes?

It’s a question that’s getting an increased amount of attention.

And for good reason — more than two in five US adults have obesity, according to the Centers for Disease Control and Prevention, and costs to treat obesity, in 2019 dollars, approached $173 billion, including productivity losses. Adults with obesity have annual healthcare costs of $1861 more than those at healthier weights.

Among recent developments:

• A proposed new rule, announced on November 26 by the Biden administration, expands coverage of anti-obesity medication for Americans who have Medicare and Medicaid. If it takes effect, an estimated 3.4 million Medicare recipients and about 4 million adult Medicaid enrollees could get access to the medications.
• As Medicare coverage goes, private insurers often follow. Observers predict that if the Centers for Medicare & Medicaid Services (CMS) covers anti-obesity drugs, more private employers may soon do the same. Recently, however, some private plans have done the opposite and dropped coverage of the pricey GLP-1s, which can cost $1000 a month or more out-of-pocket, citing excess costs for their company.
• Among the analyses about the value of weight loss on healthcare cost savings is a report published on December 5 in JAMA Network Open. Emory University experts looked at privately insured adults and adult Medicare beneficiaries with a body mass index (BMI) of ≥ 25 (classified as overweight). The conclusion: Projected annual savings from weight loss among US adults with obesity were substantial for both employee-based insurance and Medicare recipients.
• Besides helping obesity and obesity-related conditions, access to GLP-1s could have a favorable effect on productivity, others claim. That’s one focus of a 5-year partnership between the University of Manchester in England, and Eli Lilly and Company. Called SURMOUNT-REAL UK, the study will evaluate the effectiveness of tirzepatide in weight loss, diabetes prevention, and prevention of obesity-related complications in adults with obesity. It also aims to look at changes in health-related quality of life with weight loss and with changes in employment status and sick days.

CMS Proposal

In a statement announcing the proposal for Medicare and Medicaid to offer weight loss drugs, the White House noted that “tens of millions of Americans struggle with obesity” but that currently Medicare only covers the anti-obesity medications for certain conditions such as diabetes. The new proposal would expand that access to those with obesity. As of August, just 13 states cover GLP-1s in Medicaid programs, and North Carolina was the latest to do so.

Organizations advocating for health equity and recognition that obesity is a chronic disease came out in strong support of the proposal.

Kenneth E. Thorpe, PhD, a health policy expert at Emory University in Atlanta, who coauthored the recent analysis finding that weight loss offsets healthcare costs on an individual basis, told this news organization: “If finalized, this broad new coverage [by Medicare and Medicaid] would have a profound impact on the ability of Americans to access these novel medications that could significantly reduce obesity-related healthcare spending and improve overall health.”

The proposal “is modernizing the coverage of Medicare and Medicaid for obesity treatment,” agreed John Cawley, PhD, professor of economics and public policy at Cornell University in Ithaca, New York, who has researched the direct medical costs of obesity in the United States. “In this HHS rule, they talk about the scientific and medical consensus that having obesity is a chronic condition.”

The proposal requires a 60-day comment period that ends January 27, 2025, taking the timeline into the beginning of the Trump administration. Cawley and others pointed out that Trump’s pick for Health and Human Services Secretary, Robert F. Kennedy Jr, has been an outspoken opponent of the anti-obesity medicines, suggesting instead that Americans simply eat better.

 

Expert Analyses: Emory, Cornell, Southern California

So would paying for the pricey GLP-1s be smart in the long term? Analyses don’t agree.

Weight loss among those with obesity produces healthcare cost savings, said Thorpe and Peter Joski, MSPH, an associate research professor at Emory University. The two compared annual healthcare spending among privately insured adults and adult Medicare beneficiaries with a BMI of ≥ 25, using data from the Medical Expenditure Panel Survey — Household Component from April 1 to June 20, 2024.

The researchers looked at 3774 adults insured with Medicare and 13,435 with employer-sponsored insurance. Overall, those with private insurance with a weight loss of 5% spent an estimated average of $670 less on healthcare. Those with a weight loss of 25% spent an estimated $2849 less on healthcare. Among those with Medicare who had one or more comorbidities, a 5% weight loss reduced spending by $1262 on average; a 25% loss reduced it by an estimated $5442, or 31%.

Thorpe called the savings substantial. In an email interview, Thorpe said, “So yes, weight loss for people living with obesity does lower healthcare costs, as my research shows, but it also lowers other costs as well.”

These include costs associated with disability, workers’ compensation, presenteeism/absenteeism, and everyday costs, he said. He contends that “those other costs should factor into decisions about preventing and treating obesity of payors and policymakers and enhance the case for cost-effectiveness of treating obesity.”

Other research suggests it’s important to target the use of the anti-obesity medications to the BMI range that would get the most benefit. For people just barely above the BMI threshold of 30, no cost savings are expected, Cawley found in his research. But he has found substantial cost reduction if the BMI was 35-40.

However, as Cawley pointed out, as the drugs get cheaper and more options become available, the entire scenario is expected to shift.

 

The Congressional Budget Office View

In October, the nonpartisan Congressional Budget Office issued a report, “How Would Authorizing Medicare to Cover Anti-Obesity Medications Affect the Federal Budget?” Among the conclusions: Covering the anti-obesity medications would increase federal spending, on net, by about $35 billion from 2026 to 2034. Total direct federal costs of covering the medication would increase from $1.6 billion in 2026 to $7.1 billion in 2034. And it said total savings from improved health of the beneficiaries would be small, less than $50 million in 2026 and rising to $1 billion in 2034.

Covering the medications would cost $5600 per user in 2026, then down to $4300 in 2034. The offset of savings per user would be about $50 in 2026, then $650 in 2034.

 

Expert Analysis: USC Schaeffer Center

“The costs offsets come over time,” said Alison Sexton Ward, PhD, an economist at the University of Southern California’s Leonard D. Schaeffer Center, Los Angeles, and an expert on the topic. “If we look at the average annual medical cost over a lifetime, we do see cost offsets there.”

However, treating obesity means people will live longer, “and living longer costs more,” she said.

She took issue with some of the calculations in the CBO report, such as not considering the effect of semaglutide’s patent expiring in 2033.

In a white paper published in April 2023, Sexton Ward and her coauthors modeled potential social benefits and medical cost offsets from granting access to the newer weight loss drugs. The cumulative social benefits of providing coverage over the next decade would reach nearly $1 trillion, they said. Benefits would increase if private insurance expanded coverage. “In the first 10 years alone, covering weight loss therapies would save Medicare $175 billion-$245 billion, depending on whether private insurance joins Medicare in providing coverage for younger populations.”

While much focus is on Medicare coverage, Sexton Ward and others pointed out the need to expand coverage to younger ages, with the aim of preventing or delaying obesity-related complications.

 

Lilly UK Trial

A spokesperson for Lilly declined to comment further on the UK study, explaining that the study was just launching.

Besides tracking weight loss, researchers will evaluate the effect of the weight loss on sick days from work and employment. Obesity is shown to affect a person’s ability to work, leading to more absenteeism, so treating the obesity may improve productivity.

 

Beyond Health: The Value of Weight Loss

“I love the idea of studying whether access to obesity medications helps people stay employed and do their job,” said Cristy Gallagher, associate director of Research and Policy at STOP Obesity Alliance at the Milken Institute School of Public Health, George Washington University, Washington, DC. The alliance includes more than 50 organizations advocating for adult obesity treatment.

“One of our big arguments is [that] access to care, and to obesity care, will also help other conditions — comorbidities like heart disease and diabetes.”

However, access to the anti-obesity medications, by itself, is not enough, Gallagher said. Other components, such as intensive behavioral therapy and guidance about diet and exercise, are needed, she said. So, too, for those who need it, is access to bariatric surgery, she said. And medication access should include other options besides the GLP-1s, she said. “Not every medication is right for everybody.”

Cawley, Gallagher, Thorpe, and Sexton Ward had no disclosures.
 

A version of this article appeared on Medscape.com.

The question may seem simple: Could paying for weight loss medications — especially the pricey glucagon-like peptide 1 receptor agonists (GLP-1s), tirzepatide (Zepbound) and semaglutide (Wegovy) — be more cost-effective than paying for obesity care and the complications of obesity, such as cardiovascular disease and diabetes?

It’s a question that’s getting an increased amount of attention.

And for good reason — more than two in five US adults have obesity, according to the Centers for Disease Control and Prevention, and costs to treat obesity, in 2019 dollars, approached $173 billion, including productivity losses. Adults with obesity have annual healthcare costs of $1861 more than those at healthier weights.

Among recent developments:

• A proposed new rule, announced on November 26 by the Biden administration, expands coverage of anti-obesity medication for Americans who have Medicare and Medicaid. If it takes effect, an estimated 3.4 million Medicare recipients and about 4 million adult Medicaid enrollees could get access to the medications.
• As Medicare coverage goes, private insurers often follow. Observers predict that if the Centers for Medicare & Medicaid Services (CMS) covers anti-obesity drugs, more private employers may soon do the same. Recently, however, some private plans have done the opposite and dropped coverage of the pricey GLP-1s, which can cost $1000 a month or more out-of-pocket, citing excess costs for their company.
• Among the analyses about the value of weight loss on healthcare cost savings is a report published on December 5 in JAMA Network Open. Emory University experts looked at privately insured adults and adult Medicare beneficiaries with a body mass index (BMI) of ≥ 25 (classified as overweight). The conclusion: Projected annual savings from weight loss among US adults with obesity were substantial for both employee-based insurance and Medicare recipients.
• Besides helping obesity and obesity-related conditions, access to GLP-1s could have a favorable effect on productivity, others claim. That’s one focus of a 5-year partnership between the University of Manchester in England, and Eli Lilly and Company. Called SURMOUNT-REAL UK, the study will evaluate the effectiveness of tirzepatide in weight loss, diabetes prevention, and prevention of obesity-related complications in adults with obesity. It also aims to look at changes in health-related quality of life with weight loss and with changes in employment status and sick days.

CMS Proposal

In a statement announcing the proposal for Medicare and Medicaid to offer weight loss drugs, the White House noted that “tens of millions of Americans struggle with obesity” but that currently Medicare only covers the anti-obesity medications for certain conditions such as diabetes. The new proposal would expand that access to those with obesity. As of August, just 13 states cover GLP-1s in Medicaid programs, and North Carolina was the latest to do so.

Organizations advocating for health equity and recognition that obesity is a chronic disease came out in strong support of the proposal.

Kenneth E. Thorpe, PhD, a health policy expert at Emory University in Atlanta, who coauthored the recent analysis finding that weight loss offsets healthcare costs on an individual basis, told this news organization: “If finalized, this broad new coverage [by Medicare and Medicaid] would have a profound impact on the ability of Americans to access these novel medications that could significantly reduce obesity-related healthcare spending and improve overall health.”

The proposal “is modernizing the coverage of Medicare and Medicaid for obesity treatment,” agreed John Cawley, PhD, professor of economics and public policy at Cornell University in Ithaca, New York, who has researched the direct medical costs of obesity in the United States. “In this HHS rule, they talk about the scientific and medical consensus that having obesity is a chronic condition.”

The proposal requires a 60-day comment period that ends January 27, 2025, taking the timeline into the beginning of the Trump administration. Cawley and others pointed out that Trump’s pick for Health and Human Services Secretary, Robert F. Kennedy Jr, has been an outspoken opponent of the anti-obesity medicines, suggesting instead that Americans simply eat better.

 

Expert Analyses: Emory, Cornell, Southern California

So would paying for the pricey GLP-1s be smart in the long term? Analyses don’t agree.

Weight loss among those with obesity produces healthcare cost savings, said Thorpe and Peter Joski, MSPH, an associate research professor at Emory University. The two compared annual healthcare spending among privately insured adults and adult Medicare beneficiaries with a BMI of ≥ 25, using data from the Medical Expenditure Panel Survey — Household Component from April 1 to June 20, 2024.

The researchers looked at 3774 adults insured with Medicare and 13,435 with employer-sponsored insurance. Overall, those with private insurance with a weight loss of 5% spent an estimated average of $670 less on healthcare. Those with a weight loss of 25% spent an estimated $2849 less on healthcare. Among those with Medicare who had one or more comorbidities, a 5% weight loss reduced spending by $1262 on average; a 25% loss reduced it by an estimated $5442, or 31%.

Thorpe called the savings substantial. In an email interview, Thorpe said, “So yes, weight loss for people living with obesity does lower healthcare costs, as my research shows, but it also lowers other costs as well.”

These include costs associated with disability, workers’ compensation, presenteeism/absenteeism, and everyday costs, he said. He contends that “those other costs should factor into decisions about preventing and treating obesity of payors and policymakers and enhance the case for cost-effectiveness of treating obesity.”

Other research suggests it’s important to target the use of the anti-obesity medications to the BMI range that would get the most benefit. For people just barely above the BMI threshold of 30, no cost savings are expected, Cawley found in his research. But he has found substantial cost reduction if the BMI was 35-40.

However, as Cawley pointed out, as the drugs get cheaper and more options become available, the entire scenario is expected to shift.

 

The Congressional Budget Office View

In October, the nonpartisan Congressional Budget Office issued a report, “How Would Authorizing Medicare to Cover Anti-Obesity Medications Affect the Federal Budget?” Among the conclusions: Covering the anti-obesity medications would increase federal spending, on net, by about $35 billion from 2026 to 2034. Total direct federal costs of covering the medication would increase from $1.6 billion in 2026 to $7.1 billion in 2034. And it said total savings from improved health of the beneficiaries would be small, less than $50 million in 2026 and rising to $1 billion in 2034.

Covering the medications would cost $5600 per user in 2026, then down to $4300 in 2034. The offset of savings per user would be about $50 in 2026, then $650 in 2034.

 

Expert Analysis: USC Schaeffer Center

“The costs offsets come over time,” said Alison Sexton Ward, PhD, an economist at the University of Southern California’s Leonard D. Schaeffer Center, Los Angeles, and an expert on the topic. “If we look at the average annual medical cost over a lifetime, we do see cost offsets there.”

However, treating obesity means people will live longer, “and living longer costs more,” she said.

She took issue with some of the calculations in the CBO report, such as not considering the effect of semaglutide’s patent expiring in 2033.

In a white paper published in April 2023, Sexton Ward and her coauthors modeled potential social benefits and medical cost offsets from granting access to the newer weight loss drugs. The cumulative social benefits of providing coverage over the next decade would reach nearly $1 trillion, they said. Benefits would increase if private insurance expanded coverage. “In the first 10 years alone, covering weight loss therapies would save Medicare $175 billion-$245 billion, depending on whether private insurance joins Medicare in providing coverage for younger populations.”

While much focus is on Medicare coverage, Sexton Ward and others pointed out the need to expand coverage to younger ages, with the aim of preventing or delaying obesity-related complications.

 

Lilly UK Trial

A spokesperson for Lilly declined to comment further on the UK study, explaining that the study was just launching.

Besides tracking weight loss, researchers will evaluate the effect of the weight loss on sick days from work and employment. Obesity is shown to affect a person’s ability to work, leading to more absenteeism, so treating the obesity may improve productivity.

 

Beyond Health: The Value of Weight Loss

“I love the idea of studying whether access to obesity medications helps people stay employed and do their job,” said Cristy Gallagher, associate director of Research and Policy at STOP Obesity Alliance at the Milken Institute School of Public Health, George Washington University, Washington, DC. The alliance includes more than 50 organizations advocating for adult obesity treatment.

“One of our big arguments is [that] access to care, and to obesity care, will also help other conditions — comorbidities like heart disease and diabetes.”

However, access to the anti-obesity medications, by itself, is not enough, Gallagher said. Other components, such as intensive behavioral therapy and guidance about diet and exercise, are needed, she said. So, too, for those who need it, is access to bariatric surgery, she said. And medication access should include other options besides the GLP-1s, she said. “Not every medication is right for everybody.”

Cawley, Gallagher, Thorpe, and Sexton Ward had no disclosures.
 

A version of this article appeared on Medscape.com.

Rose Gerber was 39, mother to a third grader and a kindergartener, when the diagnosis came: Advanced HER2-positive breast cancer.

“On one of my first or second appointments, I took in a little picture of Alexander and Isabella,” Gerber said. Gerber showed her oncologist the picture and told her: “I’ll do anything. I just want to be there for them.”

That was 21 years ago. Today, her current cancer status is “no evidence of disease.”

Over the past 2 decades, Gerber has gotten to be there for her children. Her youngest is now a television producer and her oldest, a CPA.

In that time, Gerber has had one constant: Her oncologist, Kandhasamy Jagathambal, MD, or Dr. Jaga, as she’s often called. 

“I’ve seen multiple physicians over my 21 years, but my oncologist has always been the focal point, guiding me in the right direction,” Gerber said in an interview.

Over the years, Jaga guided Gerber through a range of treatment decisions, including a Herceptin clinical trial that the mom of two views as lifesaving. Jaga often took on the role of both doctor and therapist, even providing comfort in the smaller moments when Gerber would fret about her weight gain.

The oncologist-patient “bond is very, very, very special,” said Gerber, who now works as director of patient advocacy and education at the Community Oncology Alliance.

Gerber isn’t alone in calling out the depth of the oncologist-patient bond.

Over years, sometimes decades, patients and oncologists can experience a whole world together: The treatment successes, relapses, uncertainties, and tough calls. As a result, a deep therapeutic alliance often develops. And with each new hurdle or decision, that collaborative, human connection between doctor and patient continues to form new layers.

“It’s like a shared bonding experience over trauma, like strangers trapped on a subway and then we get out, and we’re now on the other side, celebrating together,” said Saad Khan, MD, an associate professor of medicine (oncology) at Stanford University in California.

 

Connecting Through Stress

Although studies exploring the oncologist-patient bond are limited, some research suggests that a strong therapeutic alliance between patients and oncologists not only provides a foundation for quality care but can also help improve patients’ quality of life, protect against suicidal ideation, and increase treatment adherence.

Because of how stressful and frightening a cancer diagnosis can be, creating “a trusting, uninterrupted, almost sacred environment for them” is paramount for Khan. “I have no doubt that the most important part of their treatment is that they find an oncologist in whom they have total confidence,” Khan wrote in a blog.

The stress that patients with cancer experience is well documented, but oncologists take on a lot themselves and can also experience intense stress (.

“I consider my patient’s battles to be my battles,” Khan wrote.

The stress can start with the daily schedule. Oncologists often have a high volume of patients and tend to spend more time with each individual than most.

According to a 2023 survey, oncologists see about 68 patients a week, on average, but some oncologists, like Khan, have many more. Khan typically sees 20-30 patients a day and continues to care for many over years.

The survey also found that oncologists tend to spend a lot of time with their patients. Compared with other physicians, oncologists are two times more likely to spend at least 25 minutes with each patient.

With this kind of patient volume and time, Khan said, “you’re going to be exhausted.”

What can compound the exhaustion are the occasions oncologists need to deliver bad news — this treatment isn’t working, your cancer has come roaring back and, perhaps the hardest, we have no therapeutic options left. The end-of-life conversations, in particular, can be heartbreaking, especially when a patient is young and not ready to stop trying.

“It can be hard for doctors to discuss the end of life,” Don Dizon, MD, director of the Pelvic Malignancies Program at Lifespan Cancer Institute and director of Medical Oncology at Rhode Island Hospital, Providence, wrote in a column in 2023. Instead, it can be tempting and is often easier to focus on the next treatment, “instilling hope that there’s more that can be done,” even if doing more will only do harm.

In the face of these challenging decisions, growing a personal connection with patients over time can help keep oncologists going.

“We’re not just chemotherapy salesmen,” Khan said in an interview. “We get to know their social support network, who’s going to be driving them [to and from appointments], where they go on vacation, their cat’s name, who their neighbors are.”

 

A ‘Special Relationship’

Ralph V. Boccia, MD, is often asked what he does.

The next question that often comes — “Why do I do what I do?” — is Boccia’s favorite.

“Someone needs to take these patients through their journey,” Boccia, the founder of The Center for Cancer and Blood Disorders, Bethesda, Maryland, typically responds. He also often notes that “it is a special relationship you develop with the patient and their families.”

Boccia thinks about one long-term patient who captures this bond.

Joan Pinson, 70, was diagnosed with multiple myeloma about 25 years ago, when patients’ average survival was about 4 years.

Over a quarter century, Pinson has pivoted to different treatments, amid multiple relapses and remissions. Throughout most of this cancer journey, Boccia has been her primary oncologist, performing a stem cell transplant in 2000 and steering her to six clinical trials.

Her last relapse was 2 years ago, and since then she has been doing well on oral chemotherapy.

“Every time I relapsed, by the next appointment, he’d say, ‘here is what we are going to do,’ ” Pinson recalled. “I never worried, I never panicked. I knew he would take care of me.”

Over the years, Pinson and Boccia have shared many personal moments, sometimes by accident. One special moment happened early on in Pinson’s cancer journey. During an appointment, Boccia had “one ear to the phone” as his wife was about to deliver their first baby, Pinson recalled.

Later, Pinson met that child as a young man working in Boccia’s lab. She has also met Boccia’s wife, a nurse, when she filled in one day in the chemotherapy room.

Boccia now also treats Pinson’s husband who has prostate cancer, and he ruled out cancer when Pinson’s son, now in his 40s, had some worrisome symptoms.

More than 2 decades ago, Pinson told Boccia her goal was to see her youngest child graduate from high school. Now, six grandsons later, she has lived far beyond that goal.

“He has kept me alive,” said Pinson.

 

The Dying Patient

Harsha Vyas, MD, FACP, remembers the first encounter his office had with a 29-year-old woman referred with a diagnosis of stage IV breast cancer.

After just 15 minutes in the waiting room, the woman announced she was leaving. Although office staff assured the woman that she was next, the patient walked out.

Several months later, Vyas was called for an inpatient consult. It was the same woman.

Her lungs were full of fluid, and she was struggling to breathe, said Vyas, president and CEO of the Cancer Center of Middle Georgia, Dublin, and assistant professor at Augusta University in Georgia.

The woman, a single mother, told Vyas about her three young kids at home and asked him, “Doc, do something, please help me,” he recalled.

“Absolutely,” Vyas told her. But he had to be brutally honest about her prognosis and firm that she needed to follow his instructions. “You have a breast cancer I cannot cure,” he said. “All I can do is control the disease.”

From that first day, until the day she died, she came to every appointment and followed the treatment plan Vyas laid out.

For about 2 years, she responded well to treatment. And as the time passed and the trust grew, she began to open up to him. She showed him pictures. She talked about her children and being a mother.

“I’ve got to get my kids in a better place. I’m going to be there for them,” he recalled her saying.

Vyas admired her resourcefulness. She held down a part-time job, working retail and at a local restaurant. She figured out childcare so she could get to her chemotherapy appointments every 3 weeks and manage the copays.

Several years later, when she knew she was approaching the end of her life, she asked Vyas a question that hit hard.

“Doc, I don’t want to die and my kids find me dead. What can we do about it?”

Vyas, who has three daughters, imagined how traumatic this would be for a child. She and Vyas made the shared decision to cease treatment and begin home hospice. When the end was approaching, a hospice worker took over, waiting for bodily functions to cease.

When news of a death comes, “I say a little prayer, it’s almost like a send-off for that soul. That helps me absorb the news ... and let it go.”

But when the bond grows strong over time, as with his patient with breast cancer, Vyas said, “a piece of her is still with me.”

Khan had no relevant disclosures. Boccia and Vyas had no disclosures.

A version of this article appeared on Medscape.com.

Rose Gerber was 39, mother to a third grader and a kindergartener, when the diagnosis came: Advanced HER2-positive breast cancer.

“On one of my first or second appointments, I took in a little picture of Alexander and Isabella,” Gerber said. Gerber showed her oncologist the picture and told her: “I’ll do anything. I just want to be there for them.”

That was 21 years ago. Today, her current cancer status is “no evidence of disease.”

Over the past 2 decades, Gerber has gotten to be there for her children. Her youngest is now a television producer and her oldest, a CPA.

In that time, Gerber has had one constant: Her oncologist, Kandhasamy Jagathambal, MD, or Dr. Jaga, as she’s often called. 

“I’ve seen multiple physicians over my 21 years, but my oncologist has always been the focal point, guiding me in the right direction,” Gerber said in an interview.

Over the years, Jaga guided Gerber through a range of treatment decisions, including a Herceptin clinical trial that the mom of two views as lifesaving. Jaga often took on the role of both doctor and therapist, even providing comfort in the smaller moments when Gerber would fret about her weight gain.

The oncologist-patient “bond is very, very, very special,” said Gerber, who now works as director of patient advocacy and education at the Community Oncology Alliance.

Gerber isn’t alone in calling out the depth of the oncologist-patient bond.

Over years, sometimes decades, patients and oncologists can experience a whole world together: The treatment successes, relapses, uncertainties, and tough calls. As a result, a deep therapeutic alliance often develops. And with each new hurdle or decision, that collaborative, human connection between doctor and patient continues to form new layers.

“It’s like a shared bonding experience over trauma, like strangers trapped on a subway and then we get out, and we’re now on the other side, celebrating together,” said Saad Khan, MD, an associate professor of medicine (oncology) at Stanford University in California.

 

Connecting Through Stress

Although studies exploring the oncologist-patient bond are limited, some research suggests that a strong therapeutic alliance between patients and oncologists not only provides a foundation for quality care but can also help improve patients’ quality of life, protect against suicidal ideation, and increase treatment adherence.

Because of how stressful and frightening a cancer diagnosis can be, creating “a trusting, uninterrupted, almost sacred environment for them” is paramount for Khan. “I have no doubt that the most important part of their treatment is that they find an oncologist in whom they have total confidence,” Khan wrote in a blog.

The stress that patients with cancer experience is well documented, but oncologists take on a lot themselves and can also experience intense stress (.

“I consider my patient’s battles to be my battles,” Khan wrote.

The stress can start with the daily schedule. Oncologists often have a high volume of patients and tend to spend more time with each individual than most.

According to a 2023 survey, oncologists see about 68 patients a week, on average, but some oncologists, like Khan, have many more. Khan typically sees 20-30 patients a day and continues to care for many over years.

The survey also found that oncologists tend to spend a lot of time with their patients. Compared with other physicians, oncologists are two times more likely to spend at least 25 minutes with each patient.

With this kind of patient volume and time, Khan said, “you’re going to be exhausted.”

What can compound the exhaustion are the occasions oncologists need to deliver bad news — this treatment isn’t working, your cancer has come roaring back and, perhaps the hardest, we have no therapeutic options left. The end-of-life conversations, in particular, can be heartbreaking, especially when a patient is young and not ready to stop trying.

“It can be hard for doctors to discuss the end of life,” Don Dizon, MD, director of the Pelvic Malignancies Program at Lifespan Cancer Institute and director of Medical Oncology at Rhode Island Hospital, Providence, wrote in a column in 2023. Instead, it can be tempting and is often easier to focus on the next treatment, “instilling hope that there’s more that can be done,” even if doing more will only do harm.

In the face of these challenging decisions, growing a personal connection with patients over time can help keep oncologists going.

“We’re not just chemotherapy salesmen,” Khan said in an interview. “We get to know their social support network, who’s going to be driving them [to and from appointments], where they go on vacation, their cat’s name, who their neighbors are.”

 

A ‘Special Relationship’

Ralph V. Boccia, MD, is often asked what he does.

The next question that often comes — “Why do I do what I do?” — is Boccia’s favorite.

“Someone needs to take these patients through their journey,” Boccia, the founder of The Center for Cancer and Blood Disorders, Bethesda, Maryland, typically responds. He also often notes that “it is a special relationship you develop with the patient and their families.”

Boccia thinks about one long-term patient who captures this bond.

Joan Pinson, 70, was diagnosed with multiple myeloma about 25 years ago, when patients’ average survival was about 4 years.

Over a quarter century, Pinson has pivoted to different treatments, amid multiple relapses and remissions. Throughout most of this cancer journey, Boccia has been her primary oncologist, performing a stem cell transplant in 2000 and steering her to six clinical trials.

Her last relapse was 2 years ago, and since then she has been doing well on oral chemotherapy.

“Every time I relapsed, by the next appointment, he’d say, ‘here is what we are going to do,’ ” Pinson recalled. “I never worried, I never panicked. I knew he would take care of me.”

Over the years, Pinson and Boccia have shared many personal moments, sometimes by accident. One special moment happened early on in Pinson’s cancer journey. During an appointment, Boccia had “one ear to the phone” as his wife was about to deliver their first baby, Pinson recalled.

Later, Pinson met that child as a young man working in Boccia’s lab. She has also met Boccia’s wife, a nurse, when she filled in one day in the chemotherapy room.

Boccia now also treats Pinson’s husband who has prostate cancer, and he ruled out cancer when Pinson’s son, now in his 40s, had some worrisome symptoms.

More than 2 decades ago, Pinson told Boccia her goal was to see her youngest child graduate from high school. Now, six grandsons later, she has lived far beyond that goal.

“He has kept me alive,” said Pinson.

 

The Dying Patient

Harsha Vyas, MD, FACP, remembers the first encounter his office had with a 29-year-old woman referred with a diagnosis of stage IV breast cancer.

After just 15 minutes in the waiting room, the woman announced she was leaving. Although office staff assured the woman that she was next, the patient walked out.

Several months later, Vyas was called for an inpatient consult. It was the same woman.

Her lungs were full of fluid, and she was struggling to breathe, said Vyas, president and CEO of the Cancer Center of Middle Georgia, Dublin, and assistant professor at Augusta University in Georgia.

The woman, a single mother, told Vyas about her three young kids at home and asked him, “Doc, do something, please help me,” he recalled.

“Absolutely,” Vyas told her. But he had to be brutally honest about her prognosis and firm that she needed to follow his instructions. “You have a breast cancer I cannot cure,” he said. “All I can do is control the disease.”

From that first day, until the day she died, she came to every appointment and followed the treatment plan Vyas laid out.

For about 2 years, she responded well to treatment. And as the time passed and the trust grew, she began to open up to him. She showed him pictures. She talked about her children and being a mother.

“I’ve got to get my kids in a better place. I’m going to be there for them,” he recalled her saying.

Vyas admired her resourcefulness. She held down a part-time job, working retail and at a local restaurant. She figured out childcare so she could get to her chemotherapy appointments every 3 weeks and manage the copays.

Several years later, when she knew she was approaching the end of her life, she asked Vyas a question that hit hard.

“Doc, I don’t want to die and my kids find me dead. What can we do about it?”

Vyas, who has three daughters, imagined how traumatic this would be for a child. She and Vyas made the shared decision to cease treatment and begin home hospice. When the end was approaching, a hospice worker took over, waiting for bodily functions to cease.

When news of a death comes, “I say a little prayer, it’s almost like a send-off for that soul. That helps me absorb the news ... and let it go.”

But when the bond grows strong over time, as with his patient with breast cancer, Vyas said, “a piece of her is still with me.”

Khan had no relevant disclosures. Boccia and Vyas had no disclosures.

A version of this article appeared on Medscape.com.

Rose Gerber was 39, mother to a third grader and a kindergartener, when the diagnosis came: Advanced HER2-positive breast cancer.

“On one of my first or second appointments, I took in a little picture of Alexander and Isabella,” Gerber said. Gerber showed her oncologist the picture and told her: “I’ll do anything. I just want to be there for them.”

That was 21 years ago. Today, her current cancer status is “no evidence of disease.”

Over the past 2 decades, Gerber has gotten to be there for her children. Her youngest is now a television producer and her oldest, a CPA.

In that time, Gerber has had one constant: Her oncologist, Kandhasamy Jagathambal, MD, or Dr. Jaga, as she’s often called. 

“I’ve seen multiple physicians over my 21 years, but my oncologist has always been the focal point, guiding me in the right direction,” Gerber said in an interview.

Over the years, Jaga guided Gerber through a range of treatment decisions, including a Herceptin clinical trial that the mom of two views as lifesaving. Jaga often took on the role of both doctor and therapist, even providing comfort in the smaller moments when Gerber would fret about her weight gain.

The oncologist-patient “bond is very, very, very special,” said Gerber, who now works as director of patient advocacy and education at the Community Oncology Alliance.

Gerber isn’t alone in calling out the depth of the oncologist-patient bond.

Over years, sometimes decades, patients and oncologists can experience a whole world together: The treatment successes, relapses, uncertainties, and tough calls. As a result, a deep therapeutic alliance often develops. And with each new hurdle or decision, that collaborative, human connection between doctor and patient continues to form new layers.

“It’s like a shared bonding experience over trauma, like strangers trapped on a subway and then we get out, and we’re now on the other side, celebrating together,” said Saad Khan, MD, an associate professor of medicine (oncology) at Stanford University in California.

 

Connecting Through Stress

Although studies exploring the oncologist-patient bond are limited, some research suggests that a strong therapeutic alliance between patients and oncologists not only provides a foundation for quality care but can also help improve patients’ quality of life, protect against suicidal ideation, and increase treatment adherence.

Because of how stressful and frightening a cancer diagnosis can be, creating “a trusting, uninterrupted, almost sacred environment for them” is paramount for Khan. “I have no doubt that the most important part of their treatment is that they find an oncologist in whom they have total confidence,” Khan wrote in a blog.

The stress that patients with cancer experience is well documented, but oncologists take on a lot themselves and can also experience intense stress (.

“I consider my patient’s battles to be my battles,” Khan wrote.

The stress can start with the daily schedule. Oncologists often have a high volume of patients and tend to spend more time with each individual than most.

According to a 2023 survey, oncologists see about 68 patients a week, on average, but some oncologists, like Khan, have many more. Khan typically sees 20-30 patients a day and continues to care for many over years.

The survey also found that oncologists tend to spend a lot of time with their patients. Compared with other physicians, oncologists are two times more likely to spend at least 25 minutes with each patient.

With this kind of patient volume and time, Khan said, “you’re going to be exhausted.”

What can compound the exhaustion are the occasions oncologists need to deliver bad news — this treatment isn’t working, your cancer has come roaring back and, perhaps the hardest, we have no therapeutic options left. The end-of-life conversations, in particular, can be heartbreaking, especially when a patient is young and not ready to stop trying.

“It can be hard for doctors to discuss the end of life,” Don Dizon, MD, director of the Pelvic Malignancies Program at Lifespan Cancer Institute and director of Medical Oncology at Rhode Island Hospital, Providence, wrote in a column in 2023. Instead, it can be tempting and is often easier to focus on the next treatment, “instilling hope that there’s more that can be done,” even if doing more will only do harm.

In the face of these challenging decisions, growing a personal connection with patients over time can help keep oncologists going.

“We’re not just chemotherapy salesmen,” Khan said in an interview. “We get to know their social support network, who’s going to be driving them [to and from appointments], where they go on vacation, their cat’s name, who their neighbors are.”

 

A ‘Special Relationship’

Ralph V. Boccia, MD, is often asked what he does.

The next question that often comes — “Why do I do what I do?” — is Boccia’s favorite.

“Someone needs to take these patients through their journey,” Boccia, the founder of The Center for Cancer and Blood Disorders, Bethesda, Maryland, typically responds. He also often notes that “it is a special relationship you develop with the patient and their families.”

Boccia thinks about one long-term patient who captures this bond.

Joan Pinson, 70, was diagnosed with multiple myeloma about 25 years ago, when patients’ average survival was about 4 years.

Over a quarter century, Pinson has pivoted to different treatments, amid multiple relapses and remissions. Throughout most of this cancer journey, Boccia has been her primary oncologist, performing a stem cell transplant in 2000 and steering her to six clinical trials.

Her last relapse was 2 years ago, and since then she has been doing well on oral chemotherapy.

“Every time I relapsed, by the next appointment, he’d say, ‘here is what we are going to do,’ ” Pinson recalled. “I never worried, I never panicked. I knew he would take care of me.”

Over the years, Pinson and Boccia have shared many personal moments, sometimes by accident. One special moment happened early on in Pinson’s cancer journey. During an appointment, Boccia had “one ear to the phone” as his wife was about to deliver their first baby, Pinson recalled.

Later, Pinson met that child as a young man working in Boccia’s lab. She has also met Boccia’s wife, a nurse, when she filled in one day in the chemotherapy room.

Boccia now also treats Pinson’s husband who has prostate cancer, and he ruled out cancer when Pinson’s son, now in his 40s, had some worrisome symptoms.

More than 2 decades ago, Pinson told Boccia her goal was to see her youngest child graduate from high school. Now, six grandsons later, she has lived far beyond that goal.

“He has kept me alive,” said Pinson.

 

The Dying Patient

Harsha Vyas, MD, FACP, remembers the first encounter his office had with a 29-year-old woman referred with a diagnosis of stage IV breast cancer.

After just 15 minutes in the waiting room, the woman announced she was leaving. Although office staff assured the woman that she was next, the patient walked out.

Several months later, Vyas was called for an inpatient consult. It was the same woman.

Her lungs were full of fluid, and she was struggling to breathe, said Vyas, president and CEO of the Cancer Center of Middle Georgia, Dublin, and assistant professor at Augusta University in Georgia.

The woman, a single mother, told Vyas about her three young kids at home and asked him, “Doc, do something, please help me,” he recalled.

“Absolutely,” Vyas told her. But he had to be brutally honest about her prognosis and firm that she needed to follow his instructions. “You have a breast cancer I cannot cure,” he said. “All I can do is control the disease.”

From that first day, until the day she died, she came to every appointment and followed the treatment plan Vyas laid out.

For about 2 years, she responded well to treatment. And as the time passed and the trust grew, she began to open up to him. She showed him pictures. She talked about her children and being a mother.

“I’ve got to get my kids in a better place. I’m going to be there for them,” he recalled her saying.

Vyas admired her resourcefulness. She held down a part-time job, working retail and at a local restaurant. She figured out childcare so she could get to her chemotherapy appointments every 3 weeks and manage the copays.

Several years later, when she knew she was approaching the end of her life, she asked Vyas a question that hit hard.

“Doc, I don’t want to die and my kids find me dead. What can we do about it?”

Vyas, who has three daughters, imagined how traumatic this would be for a child. She and Vyas made the shared decision to cease treatment and begin home hospice. When the end was approaching, a hospice worker took over, waiting for bodily functions to cease.

When news of a death comes, “I say a little prayer, it’s almost like a send-off for that soul. That helps me absorb the news ... and let it go.”

But when the bond grows strong over time, as with his patient with breast cancer, Vyas said, “a piece of her is still with me.”

Khan had no relevant disclosures. Boccia and Vyas had no disclosures.

A version of this article appeared on Medscape.com.

The decision to prescribe a compounded or brand-name glucagon-like peptide 1 (GLP-1) medication for obesity treatment was never simple, but recent developments have complicated it further.

Both Eli Lilly and Novo Nordisk have asked the Food and Drug Administration (FDA) to place their GLP-1 medications, tirzepatide and semaglutide, on its Demonstrable Difficulties for Compounding or DDC Lists, which would prohibit compounding the medications. Lawsuits are another issue. The Outsourcing Facility Association, a trade group, filed a lawsuit against the FDA, calling on it to restore tirzepatide to the shortage list after the FDA removed it on October 2, despite pharmacies still experiencing shortages, according to the association. The FDA is reevaluating the decision and won’t take action against compounders in the interim, with a joint status report scheduled for November 21.

In the midst of the lawsuits and pending decisions, healthcare providers are taking a variety of approaches when they need to decide between compounded vs brand-name GLP-1s for obesity treatment. The Alliance for Pharmacy Compounding, another trade group, offers a number of suggestions for doctors faced with compound or brand-name decisions and has a website tool to be sure a compounding pharmacy meets standards.

According to the FDA, a drug may be compounded for a patient who can’t be treated with an FDA-approved medication, such as a patient who has an allergy to a certain ingredient and needs medication to be made without it, or for a medication that appears on the FDA Drug Shortages List.

Here’s how five healthcare providers make the decision.

 

Physicians Weigh in

Hard pass: “I have no experience with compounded formulations by choice,” said W. Timothy Garvey, MD, MACE, an obesity specialist and the Charles E. Butterworth Jr professor and university professor at the University of Alabama at Birmingham. “I think our patients deserve better.”

However, he acknowledged: “This is a difficult situation when there is a lack of access to medications patients need.” Even so, “online prescriptions [for compounded medications] are often done without an evaluation for obesity complications and related diseases and ongoing active management, making a complications-centric approach to care impossible.”

That’s not the optimal approach to treating obesity or other chronic diseases, he said in an interview.

Rather than prescribe compounded GLP-1s for weight loss, he said, other options exist. Among them: Prescribe Ozempic off label for obesity.

“Plus, we have a good first-generation obesity medication — phentermine/topiramate — that gets close to 10% weight loss on average in clinical trials that is available and less expensive.”

Other options, he said, are to switch to lower doses of the brand name that may be available until the treatment dose needed is out of shortage status or, the less desirable option, wait for availability, which means the patient may be off the medication for a month or more.

He acknowledged none of these options solves “the problem of high costs [for brand-name drugs] and lack of insurance coverage.”

In agreement is Caroline Apovian, MD, codirector of the Center for Weight Management and Wellness at Brigham and Women’s Hospital and professor of medicine at Harvard Medical School, both in Boston, Massachusetts.

“Doctors who are obesity medicine specialists like myself in academic centers do not prescribe compounded semaglutide or tirzepatide,” she said.

Many of the compounded prescriptions, she said, come from telehealth virtual–only companies interested in profits.

Brand names preferred: “Brand-name versions as far as I’m concerned are always preferred,” said Sarah Stombaugh, MD, an obesity medicine and family medicine physician in Charlottesville, Virginia. She terms it irresponsible for a prescriber to give a patient a compounded GLP-1 if the patient has prescription coverage and the brand name is available.

Her approach: She first checks the patients’ coverage. Do they have coverage for these medications for obesity? If so, she said, she will do a prior authorization to get the brand name approved. If a brand name is available but not covered, she explores other options. One is the cash pay option for Zepbound in vials. It’s more affordable than the typical $1000 cash price for the brand name GLP-1s but still pricey, at about $400-$549 for lower doses.

She looks at drug makers’ discount coupons, or whether a patient with a history of cardiovascular issues might qualify for coverage on Wegovy. Another option is to give the patient a prescription for Mounjaro or Ozempic to fill from a Canadian pharmacy for about $400 a month.

“I think a lot of people jump quickly to compounding,” she said.

She views it as a last resort and reminds other healthcare providers that the compounded medications aren’t cheap, either, typically costing $100-$500 a month depending on dosage. And, she said, “we have many who get the brand name for $25 a month [by using discount cards and insurance coverage].”

When prescribing a compounded medication is necessary, it’s important for healthcare providers to know that the quality of the compounding pharmacies varies greatly, Stombaugh said. A prescriber needs to pick the compounding pharmacy, not the patient, and needs to vet it, she said, asking about protocols it follows for sterility and for chemical analysis, for instance.

Stombaugh is hopeful that several new medications under study and now in phase 3 trials will soon provide enough competition to drive down the price of the current brand-name GLP-1s.

History of mistrust: Robert Dubin, MD, associate professor of research at the Pennington Biomedical Research Center at Louisiana State University, Baton Rouge, and program director for its obesity medicine fellowship, sees a role for compounding and has for several years, but acknowledged that many in his community are against it.

He estimates that about 75% of his colleagues in the Baton Rouge area are opposed to prescribing compounded GLP-1s. He chalks it up to a “track record of distrust,” based on reports of infractions called out by the FDA for some compounding pharmacies as well as physicians not being familiar with the process.

Dubin said he will prescribe a compounded medication if the brand name isn’t available. Cost is also a consideration. “If there’s not a problem with availability and there’s not a problem with cost, then why compound?”

For anyone considering prescribing compounded GLP-1s, he said, “The first step, I believe, is having a relationship with the compounding pharmacy. If you don’t have that, it could be very difficult. We don’t want to send people to a black hole, and we aren’t sure what is going to happen.” He urges colleagues to educate themselves about compounding pharmacies.

Official shortage list vs real world: “The official shortage list doesn’t always reflect the real world,” said Amanda Guarniere, NP, a nurse practitioner with a self-pay telehealth and in-person practice and director of growth for Collaborating Docs, a service based in Arlington, Virginia, that pairs nurse practitioners with supervising physicians.

“When Zepbound and Mounjaro came off the [FDA] shortage list a few weeks ago, patients were still calling around and couldn’t find it in their county.”

It’s important to vet compounding pharmacies before dealing with them, she said.

“I have accounts with two compounding pharmacies who I trust,” she said. She’s researched their quality control provided and is comfortable with their standards. When appropriate, the cost savings of compounded GLP-1s over brand name is “pretty significant,” with compounded medicine costs about 20% of brand-name costs.

When the brand name is back, how might a prescriber still write a prescription for a compounded version? “Compounded versions are typically compounded with something else,” Guarniere said.

For instance, compounded tirzepatide often includes vitamin B12 and other B vitamins, which may help with the side effect of nausea. So a prescriber might decide that the compounded prescription is more appropriate and justified because the patient would benefit from the additive, she said.

 

What Else to Know: Alliance Views

On November 7, the Alliance for Pharmacy Compounding, a trade group, responded to Lilly’s request to put tirzepatide on the “demonstrably difficult to compound (DDC)” list, asking the FDA to deny it. The group also took issue with criticism of compounded GLP-1s from the Novo Nordisk CEO.

The alliance offers perspective and a number of suggestions for doctors faced with compound or brand-name decisions, including using its website tool called “Is It Legit?” to be sure a compounding pharmacy meets standards.

“When these [GLP-1] drugs came out, I don’t think anybody anticipated them to be such blockbusters,” said Tenille Davis, PharmD, a board-certified sterile compounding pharmacist and chief advocacy officer for the Alliance for Pharmacy Compounding. Shortages have plagued the GLP-1s since their approvals, with Wegovy approved on June 4, 2021, and Eli Lilly’s Zepbound on November 8, 2023.

The proposed “Demonstrably Difficult to Compound (DDC)” rule, published in March 2024, aims to finalize the six criteria for a medication to land on that list, she said. No drugs are currently on this list, Davis said.

For now, she said, prescribers faced with a compound vs brand-name decision should be aware of the pending lawsuit concerning tirzepatide and that the FDA has said it will cease most enforcement action until 2 weeks after it reviews the decision to remove the medication from the shortage list and issues a new determination.

Davis suggests prescribers have conversations now with their patients about their options and to tell them it may be necessary to transition from the compounded medicines to brand name. “This may require insurance prior authorizations, so if they are going to transition from compounded tirzepatide to Zepbound and Mounjaro, it’s good to start the process sooner rather than later so there isn’t an interruption in care.”

Earlier in 2024, the three leading obesity organizations issued a statement, advising patients that they do not recommend the use of compounded GLP-1s.

Garvey is a consultant on advisory boards for Eli Lilly, Novo Nordisk, and several other pharmaceutical companies. Apovian had no relevant disclosures. Stombaugh, Dubin, and Guarniere had no disclosures.

A version of this article appeared on Medscape.com.

The decision to prescribe a compounded or brand-name glucagon-like peptide 1 (GLP-1) medication for obesity treatment was never simple, but recent developments have complicated it further.

Both Eli Lilly and Novo Nordisk have asked the Food and Drug Administration (FDA) to place their GLP-1 medications, tirzepatide and semaglutide, on its Demonstrable Difficulties for Compounding or DDC Lists, which would prohibit compounding the medications. Lawsuits are another issue. The Outsourcing Facility Association, a trade group, filed a lawsuit against the FDA, calling on it to restore tirzepatide to the shortage list after the FDA removed it on October 2, despite pharmacies still experiencing shortages, according to the association. The FDA is reevaluating the decision and won’t take action against compounders in the interim, with a joint status report scheduled for November 21.

In the midst of the lawsuits and pending decisions, healthcare providers are taking a variety of approaches when they need to decide between compounded vs brand-name GLP-1s for obesity treatment. The Alliance for Pharmacy Compounding, another trade group, offers a number of suggestions for doctors faced with compound or brand-name decisions and has a website tool to be sure a compounding pharmacy meets standards.

According to the FDA, a drug may be compounded for a patient who can’t be treated with an FDA-approved medication, such as a patient who has an allergy to a certain ingredient and needs medication to be made without it, or for a medication that appears on the FDA Drug Shortages List.

Here’s how five healthcare providers make the decision.

 

Physicians Weigh in

Hard pass: “I have no experience with compounded formulations by choice,” said W. Timothy Garvey, MD, MACE, an obesity specialist and the Charles E. Butterworth Jr professor and university professor at the University of Alabama at Birmingham. “I think our patients deserve better.”

However, he acknowledged: “This is a difficult situation when there is a lack of access to medications patients need.” Even so, “online prescriptions [for compounded medications] are often done without an evaluation for obesity complications and related diseases and ongoing active management, making a complications-centric approach to care impossible.”

That’s not the optimal approach to treating obesity or other chronic diseases, he said in an interview.

Rather than prescribe compounded GLP-1s for weight loss, he said, other options exist. Among them: Prescribe Ozempic off label for obesity.

“Plus, we have a good first-generation obesity medication — phentermine/topiramate — that gets close to 10% weight loss on average in clinical trials that is available and less expensive.”

Other options, he said, are to switch to lower doses of the brand name that may be available until the treatment dose needed is out of shortage status or, the less desirable option, wait for availability, which means the patient may be off the medication for a month or more.

He acknowledged none of these options solves “the problem of high costs [for brand-name drugs] and lack of insurance coverage.”

In agreement is Caroline Apovian, MD, codirector of the Center for Weight Management and Wellness at Brigham and Women’s Hospital and professor of medicine at Harvard Medical School, both in Boston, Massachusetts.

“Doctors who are obesity medicine specialists like myself in academic centers do not prescribe compounded semaglutide or tirzepatide,” she said.

Many of the compounded prescriptions, she said, come from telehealth virtual–only companies interested in profits.

Brand names preferred: “Brand-name versions as far as I’m concerned are always preferred,” said Sarah Stombaugh, MD, an obesity medicine and family medicine physician in Charlottesville, Virginia. She terms it irresponsible for a prescriber to give a patient a compounded GLP-1 if the patient has prescription coverage and the brand name is available.

Her approach: She first checks the patients’ coverage. Do they have coverage for these medications for obesity? If so, she said, she will do a prior authorization to get the brand name approved. If a brand name is available but not covered, she explores other options. One is the cash pay option for Zepbound in vials. It’s more affordable than the typical $1000 cash price for the brand name GLP-1s but still pricey, at about $400-$549 for lower doses.

She looks at drug makers’ discount coupons, or whether a patient with a history of cardiovascular issues might qualify for coverage on Wegovy. Another option is to give the patient a prescription for Mounjaro or Ozempic to fill from a Canadian pharmacy for about $400 a month.

“I think a lot of people jump quickly to compounding,” she said.

She views it as a last resort and reminds other healthcare providers that the compounded medications aren’t cheap, either, typically costing $100-$500 a month depending on dosage. And, she said, “we have many who get the brand name for $25 a month [by using discount cards and insurance coverage].”

When prescribing a compounded medication is necessary, it’s important for healthcare providers to know that the quality of the compounding pharmacies varies greatly, Stombaugh said. A prescriber needs to pick the compounding pharmacy, not the patient, and needs to vet it, she said, asking about protocols it follows for sterility and for chemical analysis, for instance.

Stombaugh is hopeful that several new medications under study and now in phase 3 trials will soon provide enough competition to drive down the price of the current brand-name GLP-1s.

History of mistrust: Robert Dubin, MD, associate professor of research at the Pennington Biomedical Research Center at Louisiana State University, Baton Rouge, and program director for its obesity medicine fellowship, sees a role for compounding and has for several years, but acknowledged that many in his community are against it.

He estimates that about 75% of his colleagues in the Baton Rouge area are opposed to prescribing compounded GLP-1s. He chalks it up to a “track record of distrust,” based on reports of infractions called out by the FDA for some compounding pharmacies as well as physicians not being familiar with the process.

Dubin said he will prescribe a compounded medication if the brand name isn’t available. Cost is also a consideration. “If there’s not a problem with availability and there’s not a problem with cost, then why compound?”

For anyone considering prescribing compounded GLP-1s, he said, “The first step, I believe, is having a relationship with the compounding pharmacy. If you don’t have that, it could be very difficult. We don’t want to send people to a black hole, and we aren’t sure what is going to happen.” He urges colleagues to educate themselves about compounding pharmacies.

Official shortage list vs real world: “The official shortage list doesn’t always reflect the real world,” said Amanda Guarniere, NP, a nurse practitioner with a self-pay telehealth and in-person practice and director of growth for Collaborating Docs, a service based in Arlington, Virginia, that pairs nurse practitioners with supervising physicians.

“When Zepbound and Mounjaro came off the [FDA] shortage list a few weeks ago, patients were still calling around and couldn’t find it in their county.”

It’s important to vet compounding pharmacies before dealing with them, she said.

“I have accounts with two compounding pharmacies who I trust,” she said. She’s researched their quality control provided and is comfortable with their standards. When appropriate, the cost savings of compounded GLP-1s over brand name is “pretty significant,” with compounded medicine costs about 20% of brand-name costs.

When the brand name is back, how might a prescriber still write a prescription for a compounded version? “Compounded versions are typically compounded with something else,” Guarniere said.

For instance, compounded tirzepatide often includes vitamin B12 and other B vitamins, which may help with the side effect of nausea. So a prescriber might decide that the compounded prescription is more appropriate and justified because the patient would benefit from the additive, she said.

 

What Else to Know: Alliance Views

On November 7, the Alliance for Pharmacy Compounding, a trade group, responded to Lilly’s request to put tirzepatide on the “demonstrably difficult to compound (DDC)” list, asking the FDA to deny it. The group also took issue with criticism of compounded GLP-1s from the Novo Nordisk CEO.

The alliance offers perspective and a number of suggestions for doctors faced with compound or brand-name decisions, including using its website tool called “Is It Legit?” to be sure a compounding pharmacy meets standards.

“When these [GLP-1] drugs came out, I don’t think anybody anticipated them to be such blockbusters,” said Tenille Davis, PharmD, a board-certified sterile compounding pharmacist and chief advocacy officer for the Alliance for Pharmacy Compounding. Shortages have plagued the GLP-1s since their approvals, with Wegovy approved on June 4, 2021, and Eli Lilly’s Zepbound on November 8, 2023.

The proposed “Demonstrably Difficult to Compound (DDC)” rule, published in March 2024, aims to finalize the six criteria for a medication to land on that list, she said. No drugs are currently on this list, Davis said.

For now, she said, prescribers faced with a compound vs brand-name decision should be aware of the pending lawsuit concerning tirzepatide and that the FDA has said it will cease most enforcement action until 2 weeks after it reviews the decision to remove the medication from the shortage list and issues a new determination.

Davis suggests prescribers have conversations now with their patients about their options and to tell them it may be necessary to transition from the compounded medicines to brand name. “This may require insurance prior authorizations, so if they are going to transition from compounded tirzepatide to Zepbound and Mounjaro, it’s good to start the process sooner rather than later so there isn’t an interruption in care.”

Earlier in 2024, the three leading obesity organizations issued a statement, advising patients that they do not recommend the use of compounded GLP-1s.

Garvey is a consultant on advisory boards for Eli Lilly, Novo Nordisk, and several other pharmaceutical companies. Apovian had no relevant disclosures. Stombaugh, Dubin, and Guarniere had no disclosures.

A version of this article appeared on Medscape.com.

The decision to prescribe a compounded or brand-name glucagon-like peptide 1 (GLP-1) medication for obesity treatment was never simple, but recent developments have complicated it further.

Both Eli Lilly and Novo Nordisk have asked the Food and Drug Administration (FDA) to place their GLP-1 medications, tirzepatide and semaglutide, on its Demonstrable Difficulties for Compounding or DDC Lists, which would prohibit compounding the medications. Lawsuits are another issue. The Outsourcing Facility Association, a trade group, filed a lawsuit against the FDA, calling on it to restore tirzepatide to the shortage list after the FDA removed it on October 2, despite pharmacies still experiencing shortages, according to the association. The FDA is reevaluating the decision and won’t take action against compounders in the interim, with a joint status report scheduled for November 21.

In the midst of the lawsuits and pending decisions, healthcare providers are taking a variety of approaches when they need to decide between compounded vs brand-name GLP-1s for obesity treatment. The Alliance for Pharmacy Compounding, another trade group, offers a number of suggestions for doctors faced with compound or brand-name decisions and has a website tool to be sure a compounding pharmacy meets standards.

According to the FDA, a drug may be compounded for a patient who can’t be treated with an FDA-approved medication, such as a patient who has an allergy to a certain ingredient and needs medication to be made without it, or for a medication that appears on the FDA Drug Shortages List.

Here’s how five healthcare providers make the decision.

 

Physicians Weigh in

Hard pass: “I have no experience with compounded formulations by choice,” said W. Timothy Garvey, MD, MACE, an obesity specialist and the Charles E. Butterworth Jr professor and university professor at the University of Alabama at Birmingham. “I think our patients deserve better.”

However, he acknowledged: “This is a difficult situation when there is a lack of access to medications patients need.” Even so, “online prescriptions [for compounded medications] are often done without an evaluation for obesity complications and related diseases and ongoing active management, making a complications-centric approach to care impossible.”

That’s not the optimal approach to treating obesity or other chronic diseases, he said in an interview.

Rather than prescribe compounded GLP-1s for weight loss, he said, other options exist. Among them: Prescribe Ozempic off label for obesity.

“Plus, we have a good first-generation obesity medication — phentermine/topiramate — that gets close to 10% weight loss on average in clinical trials that is available and less expensive.”

Other options, he said, are to switch to lower doses of the brand name that may be available until the treatment dose needed is out of shortage status or, the less desirable option, wait for availability, which means the patient may be off the medication for a month or more.

He acknowledged none of these options solves “the problem of high costs [for brand-name drugs] and lack of insurance coverage.”

In agreement is Caroline Apovian, MD, codirector of the Center for Weight Management and Wellness at Brigham and Women’s Hospital and professor of medicine at Harvard Medical School, both in Boston, Massachusetts.

“Doctors who are obesity medicine specialists like myself in academic centers do not prescribe compounded semaglutide or tirzepatide,” she said.

Many of the compounded prescriptions, she said, come from telehealth virtual–only companies interested in profits.

Brand names preferred: “Brand-name versions as far as I’m concerned are always preferred,” said Sarah Stombaugh, MD, an obesity medicine and family medicine physician in Charlottesville, Virginia. She terms it irresponsible for a prescriber to give a patient a compounded GLP-1 if the patient has prescription coverage and the brand name is available.

Her approach: She first checks the patients’ coverage. Do they have coverage for these medications for obesity? If so, she said, she will do a prior authorization to get the brand name approved. If a brand name is available but not covered, she explores other options. One is the cash pay option for Zepbound in vials. It’s more affordable than the typical $1000 cash price for the brand name GLP-1s but still pricey, at about $400-$549 for lower doses.

She looks at drug makers’ discount coupons, or whether a patient with a history of cardiovascular issues might qualify for coverage on Wegovy. Another option is to give the patient a prescription for Mounjaro or Ozempic to fill from a Canadian pharmacy for about $400 a month.

“I think a lot of people jump quickly to compounding,” she said.

She views it as a last resort and reminds other healthcare providers that the compounded medications aren’t cheap, either, typically costing $100-$500 a month depending on dosage. And, she said, “we have many who get the brand name for $25 a month [by using discount cards and insurance coverage].”

When prescribing a compounded medication is necessary, it’s important for healthcare providers to know that the quality of the compounding pharmacies varies greatly, Stombaugh said. A prescriber needs to pick the compounding pharmacy, not the patient, and needs to vet it, she said, asking about protocols it follows for sterility and for chemical analysis, for instance.

Stombaugh is hopeful that several new medications under study and now in phase 3 trials will soon provide enough competition to drive down the price of the current brand-name GLP-1s.

History of mistrust: Robert Dubin, MD, associate professor of research at the Pennington Biomedical Research Center at Louisiana State University, Baton Rouge, and program director for its obesity medicine fellowship, sees a role for compounding and has for several years, but acknowledged that many in his community are against it.

He estimates that about 75% of his colleagues in the Baton Rouge area are opposed to prescribing compounded GLP-1s. He chalks it up to a “track record of distrust,” based on reports of infractions called out by the FDA for some compounding pharmacies as well as physicians not being familiar with the process.

Dubin said he will prescribe a compounded medication if the brand name isn’t available. Cost is also a consideration. “If there’s not a problem with availability and there’s not a problem with cost, then why compound?”

For anyone considering prescribing compounded GLP-1s, he said, “The first step, I believe, is having a relationship with the compounding pharmacy. If you don’t have that, it could be very difficult. We don’t want to send people to a black hole, and we aren’t sure what is going to happen.” He urges colleagues to educate themselves about compounding pharmacies.

Official shortage list vs real world: “The official shortage list doesn’t always reflect the real world,” said Amanda Guarniere, NP, a nurse practitioner with a self-pay telehealth and in-person practice and director of growth for Collaborating Docs, a service based in Arlington, Virginia, that pairs nurse practitioners with supervising physicians.

“When Zepbound and Mounjaro came off the [FDA] shortage list a few weeks ago, patients were still calling around and couldn’t find it in their county.”

It’s important to vet compounding pharmacies before dealing with them, she said.

“I have accounts with two compounding pharmacies who I trust,” she said. She’s researched their quality control provided and is comfortable with their standards. When appropriate, the cost savings of compounded GLP-1s over brand name is “pretty significant,” with compounded medicine costs about 20% of brand-name costs.

When the brand name is back, how might a prescriber still write a prescription for a compounded version? “Compounded versions are typically compounded with something else,” Guarniere said.

For instance, compounded tirzepatide often includes vitamin B12 and other B vitamins, which may help with the side effect of nausea. So a prescriber might decide that the compounded prescription is more appropriate and justified because the patient would benefit from the additive, she said.

 

What Else to Know: Alliance Views

On November 7, the Alliance for Pharmacy Compounding, a trade group, responded to Lilly’s request to put tirzepatide on the “demonstrably difficult to compound (DDC)” list, asking the FDA to deny it. The group also took issue with criticism of compounded GLP-1s from the Novo Nordisk CEO.

The alliance offers perspective and a number of suggestions for doctors faced with compound or brand-name decisions, including using its website tool called “Is It Legit?” to be sure a compounding pharmacy meets standards.

“When these [GLP-1] drugs came out, I don’t think anybody anticipated them to be such blockbusters,” said Tenille Davis, PharmD, a board-certified sterile compounding pharmacist and chief advocacy officer for the Alliance for Pharmacy Compounding. Shortages have plagued the GLP-1s since their approvals, with Wegovy approved on June 4, 2021, and Eli Lilly’s Zepbound on November 8, 2023.

The proposed “Demonstrably Difficult to Compound (DDC)” rule, published in March 2024, aims to finalize the six criteria for a medication to land on that list, she said. No drugs are currently on this list, Davis said.

For now, she said, prescribers faced with a compound vs brand-name decision should be aware of the pending lawsuit concerning tirzepatide and that the FDA has said it will cease most enforcement action until 2 weeks after it reviews the decision to remove the medication from the shortage list and issues a new determination.

Davis suggests prescribers have conversations now with their patients about their options and to tell them it may be necessary to transition from the compounded medicines to brand name. “This may require insurance prior authorizations, so if they are going to transition from compounded tirzepatide to Zepbound and Mounjaro, it’s good to start the process sooner rather than later so there isn’t an interruption in care.”

Earlier in 2024, the three leading obesity organizations issued a statement, advising patients that they do not recommend the use of compounded GLP-1s.

Garvey is a consultant on advisory boards for Eli Lilly, Novo Nordisk, and several other pharmaceutical companies. Apovian had no relevant disclosures. Stombaugh, Dubin, and Guarniere had no disclosures.

A version of this article appeared on Medscape.com.