Showing posts with label weight loss. Show all posts
Showing posts with label weight loss. Show all posts

Wednesday, June 19, 2024

Curious about new, popular weight-loss drugs? Here's a lowdown

Axios Visuals map adapted by Ky. Health News; click to enlarge
Editor's note: At the end of 2023 Kentucky led the nation in the percentage of state residents, 2.1%, who had received the new class of diabetes and weight-loss drugs.

By Katelyn Jetelina
Your Local Epidemiologist

You’ve probably heard of Ozempic by now. It is everywhere. Sales are up more than 300% and research studies are coming out like a firehose, but future population-level implications are unknown. Here, we catch you up on the science and what it may mean for you.

Ozempic (one brand name for the substance semaglutide) is one of many medications under the umbrella of “GLP-1 receptor agonists.” Others are Trulicity (dulaglutide), Wegovy (semaglutide) and Mounjaro (tirzepatide).

GLP stands for glucagon-like peptide 1. GLP-1 is a hormone produced in the intestinal system and released when you eat food. It is a natural signal saying you have eaten enough food. Naturally occurring GLP-1 comes and goes in a few minutes.

These medications mimic this natural process but for longer. Ozempic, for example, stays in our system for an entire week. It also slows down gastric emptying, thereby slowing down digestion.

How effective are these drugs? Very. The original clinical trials that supported initial FDA approval for patients with diabetes blew expectations out of the water. It improved:
  • Blood sugar control (A1c reduction)
  • Weight loss (average 15 pounds)
  • Unexpected positives, like reduced kidney disease (24% less likely to experience kidney failure and death due to kidney complications)
Since the first clinical trials, studies have tested its use in non-diabetic individuals, and its is effective in weight loss. A meta-analysis of eight studies found a significant decrease (about 10% of body weight). None saw an increase. Also, it has protective effects on the heart, such as reduced blood pressure and triglycerides.
 
What happens if you stop taking it? Unfortunately, weight (and other outcomes) rebound. As shown below, after the original clinical trial (68 weeks), people who stopped taking it regained their weight.

The use of GLP-1’s as a motivating tool for sustained change has been less studied. Will these be lifetime drugs like other medications (e.g., statin drugs for heart disease) or a tool to titer up or down in times of need? This is a big unanswered question.

While obesity often involves an energy imbalance where calories consumed exceed those expended, it’s influenced by genetics, socioeconomic status, environmental factors, and mental health. These factors contribute to a complex web of challenges that may extend beyond individual choices alone.

What about kids? Ozempic isn’t officially approved by the FDA for children (but can be used off-label), but Wegovy is approved. In 2023 alone, about 31,000 children aged 12 to 17 and 162,000 aged 18 to 25 used these medications.

A recent meta-analysis found treatments led to modest reductions in body weight and improved glycemic control in children with insulin resistance.

Ozempic babies? The term refers to a recent phenomenon where women are reporting unplanned pregnancies. This has sparked discussions on social media and in the medical community about the potential impact of these drugs on fertility. Why could this be happening? Two hypothesized pathways:
  • 1. These drugs delay gastric emptying, which can impact the effectiveness of oral birth control by slowing down the rate of absorption
  • 2. Weight loss enhances fertility, making it easier for women to become pregnant. This is particularly true for women with Polycystic Ovarian Syndrome, in which weight loss is known to boost fertility significantly.
However, it’s recommended to stop the medication two months before trying to get pregnant (see more below).
 
Datawrapper graph by YLE; data from Ghusn et al., JAMA
Are there downsides to the meds?
Like any medication, there are side effects and risks, some known and some theoretical, and many with mixed study results. Individuals must weigh the risks of obesity with the small but meaningful risks of the medication.
 
Many people experience side effects, particularly nausea and diarrhea. A recent analysis from an insurance agency found that 6 in 10 people who start the drugs quit before they see benefits because of side effects. These tend to go away after a few weeks, but they can substantially impact the quality of life until then.

Muscle loss: Most (60-75%) weight loss is from fat, but some is from non-fat, including muscle. This could lead to a rare condition called sarcopenia—loss of muscle mass and strength where you can’t do much because you’re physically weak. Research is mixed, though, on how often this happens, and it may be minimal when combined with exercise and adequate protein intake.
 
Increased risk of thyroid cancer. A small French case-control study found an elevated risk of thyroid cancers (58% elevated relative risk) and medullary thyroid cancer (78% elevated relative risk) after GLP-1’s. However, another study in Scandinavia with more than 400,000 people found no risk of thyroid cancer after 3 years. Regardless, the potential increase in absolute risk is very small.

Mental health. There is a big debate on what is happening in the brain. GLP-1 is not only produced in the gut but in the brain as well. Some evidence has correlated the usage of GLP-1 medications with suicidal ideation. However, recent evaluations by regulatory agencies found no substantial evidence after extensive review. Some studies have even suggested a potential decrease in the likelihood of anxiety and depression.

Eating disorders. It is a growing concern that GLP-1s may increase the risk of disordered eating, particularly among those who are high-risk (e.g., prior history of eating disorders).
 
Pregnancy. Pre-clinical trials on rats found GLP-1s are more likely to have offspring with birth deformities, so it’s not recommended to take during pregnancy.

While these new drugs have a strong safety profile based on available data, human studies are only about 5 years old. This means the long-term effects are not yet fully understood. However, we do have data from drugs in the same class that started testing in 2006, showing a consistent safety profile. Continued monitoring and research are essential to determine whether theoretical risks are real in light of new data.

This means decisions today must be made based on what is available and in the context of individual risk factors. For example, if you have a history of eating disorders, the risks of taking the medication may outweigh the benefits.

What does the future look like? After a century of fad diets and weight loss gimmicks, people are tired: some from fighting stigma and others from trying to lose weight unsuccessfully. These medications have proven to work, and the market shows it: GLP-1 prescriptions have increased by over 300% since 2020. A recent poll indicates that nearly half of adults express interest. But there’s no sugarcoating it: It’s expensive, about $1,000 per month without insurance. The price should decrease dramatically in about 8 years once the patent expires and the generic version comes to market.

On a population level, these drugs will likely have widespread impacts, just like the iPhone, which can be good or bad, depending on who you ask. Given the massive impact obesity has had on health in the past two decades, this could be extraordinary for lifespan and quality of life. It could also have ripple effects on the fast-food industry and save millions of dollars in health care costs.

But it could further widen health disparities, given the cost, and hurt body positivity, losing much ground gained. We also cannot ignore that these drugs benefit a billion-dollar pharmaceutical industry when underlying societal causes should be addressed for prevention. And, the fact there are numerous other benefits to a healthy lifestyle.
Bottom line

GLP-1 drugs offer much-needed hope to individuals, and a flood of studies show their effectiveness. However, there are both demonstrated and theoretical risks to consider. Regardless, obesity deserves compassion, and perhaps 21st-century tools can help foster a supportive environment that promotes lasting progress.

Wednesday, May 22, 2024

High cost of new diabetes drugs, more popular in Ky. than any other state, deprives low-income people of effective treatment

Photo by George Frey, Bloomberg, via iStock/Getty Images, KFF Health News
Editor's note: At the end of 2023 Kentucky led the nation in the percentage of state population, 2.1%, who had received the new class of diabetes and weight-loss drugs.

By Renuka Rayasam
KFF Health News

For the past year and a half, Tandra Cooper Harris and her husband, Marcus, who both have diabetes, have struggled to fill prescriptions for medications they need to control their blood sugar.

Without Ozempic or a similar drug, Cooper Harris suffers blackouts, becomes too tired to watch her grandchildren, and struggles to earn extra money braiding hair. Marcus Harris, who works as a Waffle House cook, needs Trulicity to keep his legs and feet from swelling and bruising.

The couple’s doctor has tried prescribing similar drugs, which mimic a hormone that suppresses appetite and controls blood sugar by boosting insulin production, but those are also often out of stock. Even if they are available, their Affordable Care Act insurance burdens the couple with a lengthy approval process or an out-of-pocket cost they can’t afford.

“It’s like, I’m having to jump through hoops to live,” said Cooper Harris, 46, a resident of Covington, Georgia, east of Atlanta.

Supply shortages and insurance hurdles for this powerful class of drugs, called GLP-1 agonists, have left many people who are suffering from diabetes and obesity without the medicines they need to stay healthy.

One root of the problem is the high prices set by drugmakers. About 54% of adults who had taken a GLP-1 drug, including those with insurance, said the cost was “difficult” to afford, according to KFF poll results released this month. Patients with the lowest disposable incomes who are hit the hardest; they have few resources and often struggle to see doctors and buy healthy foods.

In the United States, Novo Nordisk charges about $1,000 for a month’s supply of Ozempic, and Eli Lilly charges a similar amount for Mounjaro. Prices for a month’s supply of different GLP-1 drugs range from $936 to $1,349 before insurance coverage, according to the Peterson-KFF Health System Tracker. Medicare spending for three popular diabetes and weight loss drugs — Ozempic, Rybelsus, and Mounjaro — reached $5.7 billion in 2022, up from $57 million in 2018, according to research by KFF.

The “outrageously high” price has “the potential to bankrupt Medicare, Medicaid, and our entire health care system,” Sen. Bernie Sanders (I-Vt.), who chairs the U.S. Senate Committee on Health, Education, Labor and Pensions, told Novo Nordisk in April.

The high prices also mean that not everyone who needs the drugs can get them. “They’re kind of disadvantaged in multiple ways already and this is just one more way,” said Wedad Rahman, an endocrinologist with Piedmont Healthcare in Conyers, Georgia. Many of Rahman’s patients, including Cooper Harris, are underserved, have high-deductible health plans, or are on public assistance programs like Medicaid or Medicare.

Many drugmakers have programs that help patients get started and stay on medicines for little or no cost. But those programs have not been reliable for medicines like Ozempic and Trulicity because of the supply shortages. And many insurers’ requirements that patients receive prior authorization or first try less expensive drugs add to delays in care.

By the time many of Rahman’s patients see her, their diabetes has gone unmanaged for years and they’re suffering from severe complications like foot wounds or blindness. “And that’s the end of the road,” Rahman said. “I have to pick something else that’s more affordable and isn’t as good for them.”

GLP-1 agonists — the category of drugs that includes Ozempic, Trulicity, and Mounjaro — were first approved to treat diabetes. In the last three years, the Food and Drug Administration has approved rebranded versions of Mounjaro and Ozempic for weight loss, leading demand to skyrocket. And demand is only growing as more of the drugs’ benefits become apparent.

In March, the FDA approved the weight-loss drug Wegovy, a version of Ozempic, to treat heart problems, which will likely increase demand, and spending. Up to 30 million Americans, or 9% of the U.S. population, are expected to be on a GLP-1 agonist by 2030, the financial services company J.P. Morgan estimated.

As more patients try to get prescriptions for GLP-1 agonists, drugmakers struggle to make enough doses.

Eli Lilly is urging people to avoid using its drug Mounjaro for cosmetic weight loss to ensure enough supplies for people with medical conditions. But the drugs’ popularity continues to grow despite side effects such as nausea and constipation, driven by their effectiveness and celebrity endorsements. In March, Oprah Winfrey released an hourlong special on the medicines’ ability to help with weight loss.

It can seem like everyone in the world is taking this class of medication, said Jody Dushay, an assistant professor of medicine at Harvard Medical School and an endocrinologist at Beth Israel Deaconess Medical Center. “But it’s kind of not as many people as you think,” she said. “There just isn’t any.”

Even when the drugs are in stock, insurers are clamping down, leaving patients and health care providers to navigate a thicket of ever-changing coverage rules. State Medicaid plans vary in their coverage of the drugs for weight loss. (Kentucky's does not.) Medicare won’t cover the drugs if they are prescribed for obesity. And commercial insurers are tightening access due to the drugs’ cost.

Health-care providers cobble together care plans based on what’s available and what patients can afford. For example, Cooper Harris’s insurer covers Trulicity but not Ozempic, which she said she prefers because it has fewer side effects. When her pharmacy was out of Trulicity, she had to rely more on insulin instead of switching to Ozempic, Rahman said.

One day in March, Brandi Addison, an endocrinologist in Corpus Christi, Texas, had to adjust the prescriptions for all 18 of the patients she saw because of issues with drug availability and cost, she said. One patient, insured through a teacher-retirement health plan with a high deductible, couldn’t afford to be on a GLP-1 agonist, Addison said.

“Until she reaches that deductible, that’s just not a medication she can use,” Addison said. Instead, she put her patient on insulin, whose price is capped at a fraction of the cost of Ozempic, but which doesn’t have the same benefits. “Those patients who have a fixed income are going to be our more vulnerable patients.”

Friday, March 29, 2024

Anthem is among health insurers now covering anti-obesity drug if it is prescribed to reduce the risk of heart attack and stroke

One of Kentucky's major health insurers is among the first that have "agreed to start paying for the popular anti-obesity drug Wegovy for certain people on Medicare with heart-related conditions," The Wall Street Journal reports. Kentucky has the highest share (about 2.1%) of a state's population that have prescriptions for the new class of weight-loss drugs.

Elevance Health, the corporate parent of Anthem, joined CVS Health and Kaiser Permanente in covering Wegovy to reduce the risk of heart attacks and strokes in beneficiaries "who have cardiovascular disease, meet body-weight criteria and are covered by a Medicare drug-benefit plan," report the Journal's Peter Loftus and Anna Wilde Mathews.

State table shows Medicaid coverage numbers for March. FFS
means "fee for service," which is separate from managed care.
"Elevance, which operates many Blue Cross and Blue Shield health plans, also said it would extend coverage to people insured by a commercial plan" and would make the change in the next few weeks. "A committee of outside advisers to Elevance Health’s CarelonRx unit, which manages pharmacy benefits, has approved the use of Wegovy to reduce the risk of major cardiovascular events. . . . The company also is working with state-government agencies to determine Medicaid coverage of Wegovy." Anthem manages the Medicaid care of about 172,000 Kentuckians; county-level numbers are available.

"The insurers’ moves open up reimbursement of the coveted but costly class of weight-loss drugs, which had previously been excluded from Medicare coverage by a U.S. law and which many private health plans had resisted reimbursing because of the expense," the Journal notes. "The decisions will ease the financial burden on people who had been paying more than $1,000 out of pocket each month because their health plan wouldn’t cover the medicines, and spur use among people who couldn’t afford the heavy cost or didn’t want to pay for it. Other Medicare and commercial health plans might now feel pressure to follow suit and begin coverage. But the widening coverage could result in billions of dollars in additional drug spending by health insurers that have struggled to keep a lid on rising health costs. Wegovy lists for about $1,349 a month."

U.S. Sen. Bernie Sanders (I-Vt.), chair of the Senate's health committee, this week called on insurers to charge Americans no more than they charge in Canada for the drugs. That would lower their prices by about two-thirds.

"The insurers’ decisions arose from new guidance issued last week by the Centers for Medicare and Medicaid Services," the Journal notes. Medicare Part D plans, "which are administered by private insurers, might cover anti-obesity medications if the drugs receive approval for an additional use. Their use for weight-loss alone would still be excluded from coverage. That new guidance applies to Wegovy because the Food and Drug Administration this month approved the weight-loss drug’s use reducing the risk of heart attacks and strokes in people with a history of heart disease, and who have a body-mass index above certain thresholds. A study showed Wegovy reduced cardiovascular risk by about 20% versus a placebo."

Kentucky-based Humana, which manages the care of 155,000 Kentuckians on Medicaid and has a broad paying-customer base in the state, said it is reviewing the CMS guidance. UnitedHealth Group, which covers more than 91,000 Kentucky Medicaid beneficiaries and has many paying customers in the state, declined the Journal's request for comment.

Thursday, March 28, 2024

Chair of U.S. Senate health committee demands maker of weight-loss drugs, most popular in Kentucky, cut their prices by two-thirds

Axios Visuals map, adapted by Kentucky Health News; click it to enlarge.
Sen. Bernie Sanders of Vermont, who chairs the U.S. Senate's Health, Education, Labor and Pensions Committee says the maker of two popular diabetes and weight-loss drugs Ozempic and Wegovy should lower their list prices of “to no more than what they charge for this drug in Canada,” The Washington Post reports.

Sanders, an independent who votes with Democrats, "is demanding that Novo Nordisk slash the prices of its blockbuster drugs Ozempic and Wegovy, citing a new study on the manufacturing costs of the diabetes and weight-loss medications," the Post reports.

Kentucky leads the nation in the percentage (about 2.1%) of residemts who have received a prescription for one of the new drugs created to fight obesity and diabetes, which can also aid weight loss.

"Researchers found that a month’s supply of semaglutide — the active ingredient in both drugs — could be manufactured for an estimated 89 cents to $4.73," the Post reports, but "Novo Nordisk charges $935.77 for four weekly injections of Ozempic in the United States, while it costs about $300 per month out-of-pocket in Canada."

In response, a Novo Nordisk spokesperson didn’t address manufacturing costs but said the Danish company offers several ways to help patients and "supports changes in policy to improve patient affordability and access for those living with chronic diseases," the Post reports.

Monday, March 11, 2024

State health chief says measles risk stems from pandemic's anti-vaccine 'ideologies'; discusses how to lose weight, need for sleep

WKYT news anchor Bill Bryant, left, interviews state Health Commissioner Steven Stack, M.D.
This story has been updated.
By Al Cross
Kentucky Health News

In a wide-ranging TV interview, state Health Commissioner Steven Stack warned Kentuckians that not enough of them are vaccinated for measles, which he said is an outgrowth of reaction to the Covid-19 pandemic and the measures taken against it.

Stack reflected on his work in the pandemic and talked about other health concerns, including the opioid epidemic, weight-loss drugs and the need for Kentuckians to get more sleep, in an interview that aired Sunday, March 10, on WKYT's "Kentucky Newsmakers" with Bill Bryant.

As of March 7, the Centers for Disease Control and Prevention had recorded 45 cases of measles in 17 states: Arizona, California, Florida, Georgia, Illinois, Indiana, Louisiana, Maryland, Michigan, Minnesota, Missouri, New Jersey, New York, Ohio, Pennsylvania, Virginia and Washington.

Stack said measles was declared elimiated in the U.S. in 2000, but it has returned because vaccination rates have dropped to 90 percent. The disease may be the most contagious, and epidemiologists say 95 percent of a population needs to be vaccinated to protect those who can't or won't get the shot.

Stack said the measles-mumps-rubella (German measles) vaccine has been used since 1971, and is very effective. "We’ve got to get the public I hope, to accept that these tools help to prevent us from having far worse problems, like little babies who can't get vaccinated getting seriously ill." Children younger than 6 months are ineligible for vaccination.

Pew Research Center graph, based on Pew polling by party
Why have vaccination rates for contagious diseases dropped? "It's all gotten caught up in the Covid pandemic, in the narrative, in the ideologies that have unfortunately become associated with public health and medical science," said Stack, a physician.

Asked if he and Gov. Andy Beshear made the right calls in the pandemic, he said "I think we did the best we could with what we knew at the time." He said Kentucky outperformed most other states, considering its lower health status, which made it more vulnerable.

Stack said he and Beshear "balanced saving the most poeple [with] other harms that are worse than what you're trying to prevent." He said Kentucky's death toll of 20,000 was "far from what it would have been had we not intervened," noting that an intiial estimate was it could lose 1 to 2 percent of its population: 45,000 to 90,000 people.

Looking ahead, Stack said people 65 and older and those with other risk factors should get a Covid-19 booster this spring, and everyone should get an annual booster, much like has long been done for influenza.

Other health issues

Kentucky leads the nation in the percentage (about 2.1%) of population that has received a prescription for one of the new drugs created to fight obesity and diabetes, which can also aid weight loss.

"Overweight and obesity is a big problem in Kentucky," Stack said, noting that 38% of Kentuckians weigh too much. "That leads to diabetes, it increased your risk of cancer and cardiovasculat disease, like stroke and heart disease. It's really a major issue for us to address."

As for the drugs, "People are understandably desperate to find ways to get it under control," he said. "It's really too early to say what the long-term outcome of those medications will be. Some people have had wonderful benefits from it, have lost a lot of weight and improved their overall performance. Some individuals have had a difficult time tolerating it: persistent nausea, vomiting, or an unlucky small number with pancreatitis, so time will tell on those.

"Right now I think what we really need to do is try to think about ways to improve our environment so it's easier to eat healthier -- fresh fruits and vegetables -- and do mild things, like just go for a walk three or four days a week for 35 to 45 minutes; if you could do simple things like that, most of us could actually lose the small weight that we have to avoid becoming diabetic."

Kentucky is also one of the states most affected by the opioid epidemic. Stack said it has evolved because "The criminals keep getting more creative in the cocktails they put together and they're becomeing more and more lethal for people."

Speaking on the weekend that the nation moved its clocks to daylight saving time, Stack said lack of sleep is also a major health issue, especially for teens, who need more of it.

He said teens and adults "disrupt our sleep" with big and small screens, on TVs and smartphones. "We’ve got to get better sleep hygiene," he said, "and set out the time we need to get that eight hours of sleep."

Friday, January 19, 2024

Kentucky leads the nation in use of new class of drugs that fight diabetes and obesity; more than 2% of Kentuckians use them

Kentucky Health News
This story has been updated, as underlined.

Kentucky has the nation's highest rate of dispensed prescriptions for a new class of diabetes and obesity medications, according to the analytics company PurpleLab and published by Axios.

"For every 1,000 people in Kentucky, roughly 21 were prescribed a drug that belongs to a buzzy class of diabetes and anti-obesity medications last year," Tina Reed of Axios reports.

The drugs are GLP-1 agonists, which mimic a hormone that triggers the release of insulin, which lowers blood sugar; slows digestion; and increases the feeling of fullness after eating. They were developed to treat diabetes but have become popular in treating obesity, in which Kentucky ranks high.

"GLP-1 agonists alone can’t treat Type 2 diabetes or obesity," the Cleveland Clinic cautions. "Both conditions require other treatment strategies, like lifestyle and dietary changes." The drugs are costly, running between $900 and $1,300 a month, and most must be injected into fatty tissue.

Axios reports that after Kentucky, West Virginia had the next highest prescribing rate, at 18.9 prescriptions dispensed per 1,000 residents. That was followed by Alaska (17.5), Mississippi (16.1) and Louisiana (15.4). Rhode Island had the lowest rate (3.7), and Massachusetts was second lowest (4), followed by Wisconsin (4.3) and Hawai'i (4.3.)

The figures come from a collection of 1.9 billion claims to private insurers, Medicare (which only covers GLP-1s to treat diabetes) and Medicaid. "The data lumps the prescriptions together, so it's not possible to tease out how often these drugs are being prescribed for obesity versus diabetes," Axios notes. Kentucky Medicaid does not cover the drugs, but health insurance for state workers does.

In another story Reed reports, "Doctors are getting inundated with patients' requests . . . including from many who don't really need them. Primary-care doctors in particular, who typically have little training in obesity, have found themselves as gatekeepers for a class of injection drugs, including Novo Nordisk's Ozempic and Wegovy, that are effective but still face questions about who should take them."

Friday, January 5, 2024

'SMART' ways to make those New Year’s resolutions stick

SMART goals concept
(Wikipedia graphic)
By Shorus Minella
University of Kentucky

If you’re looking for ways to make those New Year’s resolutions stick, try finding something you are really motivated to do. You are more likely to want to work toward a goal if you enjoy the activity. 

For example, if you want to start exercising but hate exercise equipment at the gym, find a dance or aerobic class instead.

After you’ve identified something you want to work towards, be realistic and set a specific goal. 

Instead of a broad goal like “I want to eat healthy,” instead, try “I want to eat two cups of vegetables every day.” You’re more likely to accomplish and stick to a specific goal.

Following the SMART goals concept is a great guide to setting and sticking to goals. Here’s what to keep in mind when making your goals:
 
Specific – Giving yourself a very specific goal makes it easier to achieve. For example, instead of setting a goal to lose weight, aim for a specific number, such as five pounds. When you reach that goal, aim for another five pounds.
Measurable – Set yourself up for success by tracking your progress. Seeing how far you’ve come is an excellent motivator!
Achievable – If you’ve never run a step in your life, vowing to run a marathon might be a difficult goal to stick to. Start small by running around the block, then a mile, then try signing up for a community 5K.
Relevant – Your goals should be in line with your values and passions. You’re more likely to achieve your goal if you are enjoying it!
Time-Based – Give yourself a realistic time frame to complete your goal.

Most importantly, give yourself grace during your journey. Celebrate your successes but don’t get discouraged by any setbacks. Talk to your doctor or check in with the local health department for resources and programs to help you meet your goals.

Shorus Minella is a dietitian and patient education coordinator at UK HealthCare’s Gill Heart & Vascular Institute.

Tuesday, July 25, 2023

Weight-loss drugs carry high prices, many questions for seniors

By Judith Graham
KFF Health News

Corlee Morris has dieted throughout her adult life.

After her weight began climbing in high school, she spent years losing 50 or 100 pounds then gaining it back. Morris, 78, was at her heaviest in her mid-40s, standing 5 feet 10½ inches and weighing 310 pounds. The Pittsburgh resident has had diabetes for more than 40 years.

Photo by Mario Tama, Getty Images
Managing her weight was a losing battle until Morris’ doctor prescribed a Type 2 diabetes medication, Ozempic, four months ago. It’s one in a new category of medications changing how ordinary people as well as medical experts think about obesity, a condition that affects nearly 4 in 10 people 60 and older.

The drugs include Ozempic’s sister medication, Wegovy, a weight loss drug with identical ingredients, which the FDA approved in 2021, and Mounjaro, approved as a diabetes treatment in 2022. (Ozempic was approved for diabetes in 2017.) Several other drugs are in development.

The medications reduce feelings of hunger, generate a sensation of fullness, and have been shown to help people lose an average of 15% or more of their weight.

“It takes your appetite right away. I wasn’t hungry at all and I lost weight like mad,” said Morris, who has shed 40 pounds.

But how these medications will affect older adults in the long run isn’t well understood. (Patients need to remain on the drugs permanently or risk regaining the weight they’ve lost.)

Will they help prevent cardiovascular disease and other chronic illnesses in obese older adults? Will they reduce rates of disability and improve people’s ability to move and manage daily tasks? Will they enhance people’s lives and alleviate symptoms associated with obesity-related chronic illnesses?

Unfortunately, clinical trials of the medications haven’t included significant numbers of people ages 65 and older, leaving gaps in the available data.

While the drugs appear to be safe — the most common side effects are nausea, diarrhea, vomiting, constipation, and stomach pain — “they’ve only been on the market for a few years and caution is still needed,” said Mitchell Lazar, founding director of the Institute for Diabetes, Obesity and Metabolism at the University of Pennsylvania.

Given these uncertainties, how are experts approaching the use of the new obesity medications in older people? As might be expected, opinions and practices vary. But several themes emerged in nearly two dozen interviews.

Limited access

The first was frustration with limited access to the drugs. Because Medicare doesn’t cover weight loss medications and they can cost more than $10,000 a year, seniors’ ability to get the new drugs is restricted.

There is an exception: Medicare will cover Ozempic and Mounjaro if an older adult has diabetes, because the insurance program pays for diabetes therapies.

“We need Medicare to cover these drugs,” said Shauna Matilda Assadzandi, a geriatrician at the University of Pittsburgh who cares for Morris. Recently, she said, she tried to persuade a Medicare Advantage plan representative to authorize Wegovy for a patient with high blood pressure and cholesterol who was gaining weight rapidly.

“I’m just waiting for this patient’s blood sugar to rise to a level where diabetes can be diagnosed. Wouldn’t it make sense to intervene now?” she remembered saying. The representative’s answer: “No. We have to follow the rules.”

Seeking to change that, a bipartisan group of lawmakers introduced the Treat and Reduce Obesity Act, which would require Medicare to cover weight loss drugs. But the proposal has languished amid concerns over enormous potential costs for Medicare.

If all beneficiaries with an obesity diagnosis took this new class of medications, known as semaglutide drugs, annual costs would top $13.5 billion, according to a recent analysis in The New England Journal of Medicine. If all older obese adults on Medicare — a significantly larger population — took them, the cost would exceed the total spent on Medicare’s Part D drug program, which was $145 billion in 2019.

Laurie Rich, 63, of Canton, Mass., was caught off guard by Medicare’s policies, which have applied to her since she qualified for Social Security disability insurance in December. Before that, Rich took Wegovy and another weight loss medication — both covered by private insurance — and she’d lost nearly 42 pounds. Now, Rich can’t get Wegovy and she’s regained 14 pounds.

“I haven’t changed my eating. The only thing that’s different is that some signal in my brain is telling me I’m hungry all the time,” Rich told me. “I feel horrible.” She knows that if she gains more weight, her care will cost much more.

Who should take these drugs?

While acknowledging difficult policy decisions that lie ahead, experts voiced considerable agreement on which older adults should take these drugs.

Generally, the medications are recommended for people with a body mass index over 30 (the World Health Organization’s definition of obesity) and those with a BMI of 27 or above and at least one obesity-related condition, such as diabetes, high blood pressure, or high cholesterol. There are no guidelines for their use in people 65 and older. (BMI is calculated based on a person’s weight and height.)

But those recommendations are problematic because BMI can under- or overestimate older adults’ body fat, the most problematic feature of obesity, noted Rodolfo Galindo, director of the Comprehensive Diabetes Center at the University of Miami.

Dennis Kerrigan, director of weight management at Henry Ford Health in Michigan, a system with five hospitals, suggests physicians also examine waist circumference in older patients because abdominal fat puts them at higher risk than fat carried in the hips or buttocks. (For men, a waist over 40 inches is of concern; for women, 35 is the threshold.)

Fatima Stanford, an obesity medicine scientist at Massachusetts General Hospital, said the new drugs are “best suited for older patients who have clinical evidence of obesity,” such as elevated cholesterol or blood sugar, and people with serious obesity-related conditions such as osteoarthritis or heart disease.

Since going on Mounjaro three months ago, Muriel Branch, 73, of Perryville, Arkansas, has lost 40 pounds and stopped taking three medications as her health has improved. “I feel real good about myself,” she told me.

When adults with obesity lose weight, their risk of dying is reduced by up to 15%, according to Dinesh Edem, Branch’s doctor and the director of the medical weight management program at the University of Arkansas for Medical Sciences.

Still, weight loss alone should not be recommended to older adults, because it entails the loss of muscle mass as well as fat, experts agree. And with aging, the shrinkage of muscle mass that starts earlier in life accelerates, contributing to falls, weakness, the loss of functioning, and the onset of frailty.

Between ages 60 and 70, about 12% of muscle mass falls away, researchers estimate; after 80, it reaches 30%.

To preserve muscle mass, seniors losing weight should be prescribed physical activity — both aerobic exercise and strength training, experts agree.

Also, as older adults taking weight loss drugs eat less, “it’s critically important that their diet includes adequate protein and calcium to preserve bone and muscle mass,” said Anne Newman, director of the Center for Aging and Population Health at the University of Pittsburgh.

Ongoing monitoring of older adults having gastrointestinal side effects is needed to ensure they’re getting enough food and water, said Jamy Ard, co-director of Wake Forest Baptist Health’s Weight Management Center.

Generally, the goal for older adults should be to lose 1 to 2 pounds a week, with attention to diet and exercise accompanying medication management. That's important, said Sukhpreet Singh, system medical director at Henry Ford’s weight management program.

“My concern is, once we put patients on these obesity drugs, are we supporting lifestyle changes that will maintain their health? Medication alone won’t be sufficient,” Singh said. “We will still need to address behaviors.”

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

Tuesday, April 18, 2023

Ads and social media hype new, expensive weight-loss drugs; doctors sound alarms about off-label uses and side effects

AFP photo via Getty Images and KFF Health News
By Darius Tahir
and Hannah Norman
KFF Health News

Suzette Zuena is her own best advertisement for weight loss.

Zuena, the “founder/visionary” of LH Spa & Rejuvenation in Livingston and Madison, N.J, has dropped 30 pounds. Her husband has lost 42 pounds.

“We go out a lot,” Zuena said of the pair’s social routine. “People saw us basically shrinking.” They would ask how the couple did it. Her response: Point people to her spa and a relatively new type of medication — GLP-1 agonists, a class of drug that’s become a weight-loss phenomenon.

But she’s not just spreading her message in person. She’s also doing it on Instagram. And she’s not alone. A chorus of voices is singing these drugs’ praises. Last summer, investment bank Morgan Stanley found mentions of one of these drugs on TikTok had tripled. People are streaming into doctors’ office to inquire about what they’ve heard are miracle drugs.

What these patients have heard, doctors said, is nonstop hype, even misinformation, from social media influencers. “I’ll catch people asking for the skinny pen, the weight-loss shot, or Ozempic,” said Priya Jaisinghani, an endocrinologist and clinical assistant professor at New York University’s Grossman School of Medicine.

Competition to claim a market that could be worth $100 billion a year for drugmakers alone has triggered a wave of advertising that has provoked the concern of regulators and doctors worldwide. But their tools for curbing the ads that go too far are limited — especially when it comes to social media. Regulatory systems are most interested in pharma’s claims, not necessarily those of doctors or their enthused patients.

Few drugs of this type are approved by the Food and Drug Administration for weight loss; those include Novo Nordisk’s Wegovy. But after shortages made that treatment harder to get, patients turned to other pharmaceuticals, like Novo Nordisk’s Ozempic and Eli Lilly’s Mounjaro, that are approved only for Type 2 diabetes. Those are often used off-label — though you wouldn’t hear that from many of their online boosters.

The drugs have shown promising clinical results, Jaisinghani and her peers emphasize. Patients can lose as much as 15% of their body weight. Novo Nordisk is sponsoring research to examine whether Wegovy causes reductions in the rate of heart attacks for patients with obesity.

The medications, though, come at a high price. Wegovy runs patients paying cash at least $1,305 a month in the Washington, D.C., area, according to a GoodRx search in late March. Insurers only sometimes cover the cost. And patients typically regain much of their lost weight after they stop taking it.

Hype drives demand

But patients are not necessarily coming to doctors’ offices now because of the science. They are citing things they saw on TikTok, like Chelsea Handler and other celebrities talking about their injections. It leads to the questions “how come she can get it” and “why can I not,” said Juliana Simonetti, a physician and co-director of the comprehensive weight management program at the University of Utah.

The excitement — which doctors worry may cause some patients to use medications inappropriately — is coming also from business interests. Some are doctors promoting their venture-capital-backed startups. Others are spas hawking everything from wrinkle-smoothing and lip-plumping to, yes, weight-loss benefits of semaglutide, the active ingredient in Wegovy and Ozempic; their prices, often in the hundreds of dollars, are well below what consumers would pay if picking up the prescription at a pharmacy.

In the U.S., the FDA has oversight over ads from the pharmaceutical industry, which must acknowledge risks and side effects of drugs. But ads from people who write prescriptions don’t necessarily have the same restrictions. FDA regulations apply if the prescriber is working on behalf of a regulated entity, like a pharmaceutical manufacturer or distributor.

“The FDA is also committed to working with external partners, including the Federal Trade Commission, to address concerns with prescription drug marketing practices of telehealth companies on various platforms, including social media,” agency spokesperson Jeremy Kahn emailed KFF Health News.

Pharma firms run campaigns to educate health-care professionals or raise “awareness” that may indirectly tout drugs. Novo Nordisk has an ongoing internet campaign to redefine and destigmatize how Americans think of obesity — and, left unmentioned, the drugs that treat it.

Australian regulators have taken down nearly 1,900 ads as of early March for improperly plugging various GLP-1 agonists, an agency spokesperson told KFF Health News. Novo Nordisk says it didn’t put up the ads, the majority of which were for their product Ozempic. The regulators are declining to say who’s involved.

Doctors are also sounding alarms about the publicity. They believe patients will be driven to use these medications off-label, obtain unreliable forms of these drugs, or exacerbate other health conditions, like eating disorders. The drugs act in part as an appetite suppressant, which can dramatically reduce calorie intake to a concerning degree when not paired with nutritional guidance.

Elizabeth Wassenaar, a regional medical director of the Eating Recovery Center, said she believes the drugs and associated advertising buildup will inadvertently trigger eating disorders. KFF Health News found ads showing thin patients measuring themselves with a tape measure and stepping on the scale, with accompanying captions goading viewers into going on GLP-1s.

“They’re being marketed very, very pointedly to groups that are vulnerable to experiencing body image dissatisfaction,” she said.

Remi Bader, a curve model and TikTok creator specializing in documenting her “realistic” clothing buys, told one podcast her story of coming off a “few months” on Ozempic. She said she gained twice the weight back and that her binge eating disorder got “so much worse.” One study, published in the journal Diabetes, Obesity and Metabolism, found two-thirds of lost weight came back after discontinuation of semaglutide.

But social media users and influencers — whether with white coats or ordinary patients — are hopping on every platform to spread news of positive weight-loss outcomes. There are those, for instance, who had gastric bypass surgery that didn’t work and are now turning to TikTok for guidance, support, and hope as they begin taking a GLP-1. There’s even a poop-centric Facebook group in which people discuss the sometimes fraught topic of the drugs’ effect on their bowel movements.

Commercialism, compounding spark excitement, concern

Some have been so delighted by their medication-assisted weight loss they have become brand ambassadors. Samantha Klecyngier has dropped at least 58 pounds since she started on Mounjaro. She heard of the drug and her telemedicine weight loss program, Sequence, on TikTok. She and many others who have experienced considerable weight loss since starting the medication regimen point to its positive impact and their improved quality of life. Now she officially promotes the company on the app.

Though Klecyngier, a mother of two from the Chicago area, is not diabetic, she uses Mounjaro. When she was growing up, her parents had Type 2 diabetes and other chronic diseases that led them both to have open-heart surgery. Her father lost his life to complications of diabetes. She wants to avoid that fate.

But Klecyngier’s story — combining a personal journey with a profit-making entity — is symbolic of another trend on social media: commercialism. There’s a spate of startups eyeing big money matching pharmaceuticals and related support with patients. (Sequence, the company Klecyngier pitches, just got acquired by WW, also known as WeightWatchers.)

Some doctors use social media to educate viewers about the drugs. Michael Albert, chief medical officer of telehealth practice Accomplish Health, says offering information to his more than 250,000 followers has helped point patients to the medical practice. It’s received thousands of patient inquiries, more than the clinic can take on.

Companies like Accomplish — startups with well-credentialed doctors — are the glossy side of this social media boom.

But there are others — like many spas and weight loss centers — that offer the drugs, sometimes without much medical support, often alongside Botox and dermal fillers. Obesity doctors worry such marketing is creating unrealistic expectations.

Some spas and telemedicine operators claim to have “compounded” semaglutide. But compounding — when pharmacies, rather than drug manufacturers, prepare a drug — is a risky proposition, doctors caution. “The risks are enormous,” Simonetti said, warning of potential contamination from poor compounding practices. “The risks of getting bacteria,” she warned, “the risks include death.”

Weight loss clinics also frequently tout unconventional additions to semaglutide, including vitamin B-12 and amino acids. Some patients incorrectly believe the former helps with nausea, Jaisinghani said; other clinics tout greater weight loss.

Novo Nordisk spokesperson Allison Schneider told KFF Health News in an email that the company shares doctors’ concerns about compounding and that it’s begun sending letters warning “certain health-care providers” about the related risks.

Some operations defend their use of often-cheaper compounded drugs. LH Spa & Rejuvenation, founded by Zuena, offers a compounded semaglutide formulation from QRx Weight Loss for $500 over four weeks. The spa learned about the regimen from a doctor. “I’m purchasing it,” Zuena said. “It comes next-day air in legitimate vials with lot numbers, expirations.” Patients’ injections and dosages are overseen by on-site medical staff.

Most operators in this burgeoning industry are keen to emphasize their products’ high quality or their company’s good works, as they seek money. Ro, a telehealth firm offering GLP-1s, said its marketing campaign in the New York City subway “aims to start an important, sometimes difficult, conversation focused on de-stigmatizing obesity as a condition.”

This widespread tactic is nothing short of maddening for pharma-industry critics. “They talk about trying to destigmatize obesity at the same time they’re talking about losing weight. They’re co-opting the concept,” said Judy Butler, a research fellow at PharmedOut, a Georgetown University Medical Center project focusing on evidence-based practices for drugs. “They’re trying to sell a weight loss drug.”

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF—an independent source of health policy research, polling, and journalism. Learn more about KFF.

Sunday, January 15, 2023

Dietitian says even 10% weight loss has health benefits; weight-loss drugs, diets and pediatric guidelines are in the news

American Heart Association photo
By Melissa Patrick
Kentucky Health News

As the end of January approaches and that New Year's resolution to lose weight may have already been forgotten, it's important to remember that if you are overweight, it's worth the effort to hang onto that resolution. Even losing up to 10 percent of your body weight can provide health benefits. 

Karen Klefot, registered dietitian and diabetes consultant at the Barnstable Brown Diabetes Center at the University of Kentucky, told Kentucky Health News that it's important for a person to set short-term goals when they are trying to lose weight and that even a 10% weight loss can improve blood pressure, sleep, diabetes, cholesterol and energy levels.  

"There is value in losing up to 10 percent of an individual's weight," Klefot said. "Oftentimes, we feel like we have to lose 50 pounds, but . . . that's a lot of weight, when really, honestly, you know, we can have those health benefits with it only being 10 percent."

Klefot offered several suggestions for getting started with a weight-loss plan, including keeping track of your daily exercise and daily food intake as a way to evaluate where some lifestyle changes can be made. 

"I think it's important to focus on things that are realistic and attainable, especially when it comes to weight loss," she said, later adding, "And I would say to focus on one to two pounds per week." 

For example, she said one easy lifestyle change is to trade sugar-sweetened beverages for water or to add more fiber-rich foods, fruits, vegetables and whole grains to the diet. And, she said, eat less fast food, which takes some planning ahead.    

Asked about the popular low-carbohydrate diets, Klefot stressed that it's important to not cut out carbohydrates completely because they are the main fuel source for our bodies. 

"We're not supposed to be depriving our body of carbs," she said. Also, "We need healthy fat and we need protein."

Further, she said it's important to limit sweet treats to "every now and then, but maybe not every single day." And if you have a strong sweet tooth, try adding more fruit to your diet. 

Klefot also noted that increasing your physical activity is important for weight loss, noting that the general recommendation is for a person to get 150 minutes of moderate-intensity aerobic activity a week. The Centers for Disease Control and Prevention adds two or more days of muscle-strengthening activities a week to that recommendaton. 

MyPlate.gov is the federal government's guide to healthy eating.
Recognizing that insurance does not always cover weight-loss efforts, Klefot encouraged people to look at reliable sources when it comes to seeking solutions, such as MyPlate.gov, the U.S. Department of Agriculture's guide to healthy eating. In addition, she encouraged yearly physicals and said local health departments often offers diabetes programs. 

"I wish more insurances would cover more appointments with a registered dietitian because I think more patients would be able to come," which would likely reduce both obesity and diabetes in Kentucky, Klefot said. 

Best diets in 2023

Each year U.S. News & World Report reviews a list of science-backed diets and ranks them. The diets are reviewed by a panel of leading medical and nutrition specialists in diabetes, heart health and weight loss. 

Of the 24 diets that were reviewed, the Mediterranean diet ranked first. This diet focuses on plant-based foods, like fruits and vegetables, while incorporating whole grains, beans, nuts, seafood, lean poultry and unsaturated fat from extra-virgin olive oil.

The DASH diet, which stands for dietary approaches to stop hypertension, or high blood pressure, tied for second place. It also emphasizes fruits, vegetables, whole grains, lean protein and low-fat dairy, which are high in blood pressure-lowering nutrients, like potassium, calcium, magnesium and fiber.

Also tied for second was the flexitarian diet, a semi-vegetarian diet that allows a person to be a vegetarian most of the time, but to still be able to enjoy meat on a special occasion. 

New weight-loss guidelines for children

For the first time in 15 years, the American Academy of Pediatrics has released new evidence-based recommendations for treating childhood obesity, with an emphasis on early and intensive treatment. 

The new guidelines stress that obesity is a chronic disease and should be treated as such. And while the guidelines continue to say that intensive behavioral therapy and lifestyle changes should be a first-line approach, for the first time AAP now recommends children 12 and older be considered for anti-obesity medications and those 13 and older with severe obesity be considered for weight-loss surgery. 

“There is no evidence that ‘watchful waiting’ or delayed treatment is appropriate for children with obesity,” Dr. Sandra Hassink, an author of the guideline and vice chair of the Clinical Practice Guideline Subcommittee on Obesity, said in an AAP news release.

NBC News reports that there are now four drugs approved for obesity treatment in teens starting at age 12: "Orlistat, Saxenda, Qsymia and Wegovy — and one, phentermine, for teens age 16 and older. Another drug, called setmelanotide (brand name Imcivree), has been approved for kids age 6 and older who have Barde-Biedl syndrome, a genetic disease that causes obesity."

In Kentucky, 39% of children were either overweight or obese in 2019-20, up from 37% in 2016-2017, according to the 2022 Kids Count Data Book. The State of Childhood Obesity report says that in 2020-2021, 25.5% of Kentucky's children were obese. 

New anti-obesity drugs are expensive

The Trust for America's Health latest annual report says four of every 10 Kentucky adults are obese and 72.3% are either obese or overweight, ranking the state third in the nation.

New drug treatments for obesity are working, but they are expensive and are not always covered by health insurance, Lesley Stahl reported Jan. 1 on CBS's "60 Minutes." 

One of those drugs is semaglutide, marketed under the brand Ozempic for Type 2 diabetes and Wegovy, in higher doses, for weight loss. CBS reports Ozempic was first approved by the Food and Drug Administration as a type 2 diabetes medication in 2017. Wegovy was approved by the FDA as a chronic weight management treatment in 2021.

In support of these medications, Dr. Fatima Cody Stanford, an obesity doctor at Massachusetts General Hospital and associate professor at Harvard Medical School, told Stahl that the common beliefs about obesity are all wrong. It's not willpower, she said, "It's a brain disease. And the brain tells us how much to eat and how much to store." Further, she said, "The number one cause of obesity is genetics." 

Doctors are frustrated that there are drugs that works for obesity, but insurance companies won't cover them. 

"We are frustrated every single day when we see patients who desperately need to lose weight to reduce diabetes, reduce the hypertension, stroke, heart disease, and we can't give them this fabulous, robust medication that is very effective and safe. And we can't give it to them because insurance won't cover it," Dr. Caroline Apovian, co-director of the Weight Management and Wellness Center at Brigham and Women's Hospital in Boston, told Stahl. 

In Kentucky, Ozempic and Wegovy are not covered by Medicaid for weight loss. Stahl reported that  Rhode Island officials have decided that health insurance for their state employees will cover the entire class of anti-obesity drugs.

NBC News reports that experts are confident that the FDA will likely approve Eli Lilly & Co.'s drug tirzepatide for weight loss in 2023, but it also will be expensive and there is little indication that insurers will widely cover it. 

Lilly declined to comment on the new drug's cost, but NBC reports, "Outside experts said it is possible the drugmaker could price it similarly to Wegovy, which carries a list price of around $1,500 for a month’s supply, and Saxenda, which costs about $1,350 for a month’s supply."

Friday, January 7, 2022

Looking to be more active in 2022? Here are some tips

Photo by Julia Larson from Prexels

The American Chiropractic Association recently released five strategies to help people establish a more active lifestyle.

The release came in early January, when people normally try to become healthier and lose weight, but pandemic restrictions during the past two years have caused many people to be even less active than normal. If you have been less than active the past year or two, consider the following strategies to help you get moving again:
  • Just start moving. According to Matthew Dimond of the ACA, the type of exercise is less important than whether or not a person is moving. In his words: "Make it fun."
  • Be consistent. After getting started, the most important thing is consistency. “The human body—and the human mind for that matter—like normalcy,” DiMond explains. “Wherever you currently are is what your body likes to do. The initial effort can be monumental; being consistent with it will create a habit.”
  • Be accountable. Consider finding an exercise partner or activities that involve other people. Such connections can often inspire, drive, and motivate people to focus on their health goals and move forward.
  • Be safe. When starting to move again after being inactive, assume you will not be as physically fit as you once were. Be aware of your limits and focus on what works for you, rather than comparing yourself to others or to your previous fitness level. Also be mindful of any pain you experience. 
  • Identify your motivation. Motivation can be a challenge for people who start to move after a period of inactivity. “Willpower is not enough,” DiMond says. He encourages people to define their goals in terms of “what” instead of “why.” Ask yourself what you are trying to accomplish and create measurements based on that goal. Do you want to run a 5K? Do you want to walk your dog every day or be able to pick up your grandchild? Determine your “what” and set metrics to achieve it.
“Brief periods of inactivity usually aren’t that big of a deal,” DiMond says. “However, long-standing inactivity will lead to more fatigue, tiredness, and lethargy. Depending on where you are in the lifespan, muscle fiber types can start to change, and that can be detrimental. In the elderly, less movement and decreasing load demands can have a negative impact on their quality of compact bone.”