- Lindsay Clancy strangled her three kids while on 13 psychiatric drugs. Can postpartum psychosis be a defence? The Independent
- Lindsay Clancy, charged with killing her 3 kids, planned it all out, prosecutors allege CBS News
- 911 Dispatch Call in Lindsay Clancy Case Reveals What First Responders Found at Massachusetts Family’s Home Inside Edition
- Lindsay Clancy’s defense implies she heard ‘command hallucinations.’ What are they? The Boston Globe
- Lindsay Clancy psychiatrist says she is ‘flat as a board’ and ‘wondering what’s going on’ Daily Mail
- View Full Coverage on Google News
Tag Archives: drugs
Ozempic And Wegovy: What To Know About Semaglutide Weight Loss Drugs
A new class of weight loss drugs on the market have been making waves since they were authorized as a treatment for obesity in 2021. Semaglutide injections, which you may know as Wegovy or Ozempic, have become wildly popular over the past several months, thanks to the buzz they’ve received from TikTok influencers (and rumors of use among some celebrities).
The prescription injections were introduced as a diabetes treatment in 2017, but people soon realized that the medications — which help people with diabetes to manage their blood sugar levels — also led to significant weight loss in people with obesity who’d struggled to lose weight with other treatments.
From there, interest in the drugs grew, and after clinical trials confirmed what people suspected — that semaglutide injections help people lose weight — demand soared, so much so that pharmacies across the country are experiencing shortages in both Wegovy and Ozempic. Obesity specialists understand the hype; this kind of prescription weight loss medication has been a long time coming.
“For those of us who treat obesity, this is a game-changer we’ve never seen before,” said Dr. Dan Azagury, a bariatric surgeon at Stanford Health Care. “This is the first time ever that we have really effective drugs to treat obesity.”
Obesity is one of the most common chronic health conditions in the United States, but until recently, we haven’t had very effective drugs to address the health complications it’s commonly linked to, such as high cholesterol and high blood pressure. Aside from lifestyle changes like diet and exercise, the go-to intervention for obesity has been surgery (think: gastric bypass or the duodenal switch).
According to Azagury, many obesity specialists noticed that, in the wake of receiving bariatric surgery, many patients were suddenly no longer diabetic. Upon investigating the reason for this, researchers identified new gut hormones, including one called glucagon-like peptide (GLP-1), that reacted to food going into the gut.
Further testing revealed that GLP-1, which increases after bariatric surgery, improves blood sugar levels, and consequently helps with diabetes. “That’s why major diabetes goes away within days of surgery,” Azagury said.
After this discovery, pharmaceutical companies set out to form a diabetes drug that could activate those GLP-1 receptors. That’s what led to the development of semaglutide ― a synthetic compound that mimics the effects of GLP-1 ― and later the semaglutide-based diabetes drug Ozempic, which got approval from the Food and Drug Administration in 2017.
The other key finding about GLP-1: It slows down digestion and reduces food intake, according to Dr. Janelle Duah, a Yale Medicine internist. This is why Ozempic, which is intended for diabetes, has been and continues to be prescribed off-label for weight loss, Azagury said.
The weight loss effects of GLP-1 (which are revved up through semaglutide), combined with the wild demand for Ozempic, drove the drug manufacturer, Novo Nordisk, to create a very similar drug specifically for weight loss: Wegovy. Essentially just a stronger dosage of Ozempic, Wegovy got FDA approval in June 2021.
Who’s a candidate for the medications?
Wegovy, a once-a-week shot, is for adults who have a body mass index over 30, or who have a BMI above 27 with at least one weight-related health issue (think: high blood pressure, diabetes or high cholesterol). It’s also meant to supplement physical activity and dietary changes, which is why obesity specialists like Azagury recommend that patients work with a comprehensive team of providers, including dietitians and therapists, if they can afford to. Patients can get the prescription through their primary care doctor, too.
Many people find that the injections help them feel fuller longer and reduce sugary cravings. It “makes them crave protein and fiber more — thus helping them stick to diet changes that can further enhance their weight loss,” Duah said. Some people say it also reduced their desire to drink alcohol, and helped them to get better sleep.
Ozempic is approved for Type 2 diabetes, not obesity or weight loss, although people are getting it off-label for weight loss purposes. It’s entirely legal for doctors to prescribe meds off-label, but this is likely adding to ongoing drug shortages — which is a major issue for people with diabetes who can’t get hold of the medications.
What’s the overall take on these weight loss medications?
Obesity doctors are thrilled. Often, people retain weight because of health problems out of their control, not for lack of willpower or discipline. Many patients with obesity have tried it all, only to see minimal results. “Now we have something to help them,” Azagury said.
According to Duah, the recent surge in prescriptions, for the most part, is for good reason. “It is by far the most efficacious weight loss medication on the market, with users losing up to 20% of their starting body weight,” Duah said.
And even though interest in these drugs is soaring, Azagury thinks they can help still more people. The original class of obesity drugs from the 1960s and ’70s had nasty consequences and likely soured many people on the whole idea. It might take some convincing for more people to accept that there’s finally an effective drug for weight loss available, Azagury said.
There’s also the issue of cost. These drugs aren’t always covered by insurance, Azagury said, so it can get expensive (to the tune of $1,500 to $1,800 a month). “That is the biggest challenge people will face,” Azagury said. “It’s FDA-approved; that doesn’t mean insurance is going to pay for it.”
According to Duah, this is one of the main reasons providers end up prescribing Ozempic instead. Unlike Wegovy, Ozempic is often covered for diabetes or insulin resistance, so patients looking for semaglutide injections can get access to them at a reasonable price.
There are some risks associated with semaglutide injections
As with any drug, there are risks — but the injections are surprisingly well tolerated, Azagury said. The most common side effects are gastrointestinal issues, like nausea, vomiting, constipation, gas and heartburn. These GI-related side effects should subside as your body gets used to the injections; until then, they can mostly be handled by eating smaller, more frequent meals or taking over-the-counter medications like bismuth subsalicylate or heartburn relief tablets, Duah said. (If the side effects persist, be sure to talk to your doctor about finding relief or other, more tolerable options.)
In rare cases, semaglutide injections can lead to thyroid tumors, which can be cancerous. Other potential serious side effects include pancreatitis, gallbladder problems, low blood sugar, kidney issues, allergic reactions and depression. The injections also shouldn’t be used with other drugs that contain semaglutide or that target GLP-1 receptors.
We’re still learning about long-term side effects, since the drug is relatively new. The injections aren’t a quick fix, and most people will have to stay on the medications for at least a year (and likely longer) to meet their weight loss goals and improve their health, according to Azagury. One study found that many people who stop taking the medications rapidly gain the weight back, supporting the growing belief that the injections are meant to be taken for the long haul.
Other than a slightly higher risk of gallstones (which is common with many types of rapid weight loss), we haven’t seen any long-term effects with liraglutide, a similar drug that’s been on the market since 2010. Azagury expects the same will be true with semaglutide-based medications, given their similarity ― but, of course, time will tell.
If you’re interested in semaglutide injections, talk to your doctor. Understand the risks and benefits, and keep in mind that due to inflation, supply issues and growing demand, these drugs tend to be back-ordered — often for the people who need them most. Hopefully, supply will ramp up soon and more insurers will cover the cost. That, Duah said, will help more people get the drugs at a fair price.
“If insurances covered weight loss medications like Wegovy and supply was increased, we wouldn’t be seeing these issues with keeping Ozempic stocked on our pharmacies’ shelves,” Duah said.
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What it’s like to take the blockbuster drugs Ozempic and Wegovy, from severe side effects to losing 50 pounds
For the two months Carey Yazeed took Ozempic, the drug worked as intended. Yazeed has type 2 diabetes, and the weekly injection lowered her blood sugar levels. But it also brought side effects she considered unbearable, including vomiting, fatigue, headaches and stomach cramps.
Five weeks into taking the medication, Yazeed said, she found herself unable to move off the bathroom floor.
“I had vomited so much that I didn’t have the energy to get up and I was basically lying in it,” she said. “I couldn’t even raise my head to vomit in the commode. It was so bad.”
The severe effects Yazeed faced aren’t common, but people’s experiences taking Ozempic and its sister drug, Wegovy, can vary widely — from substantial weight loss and minimal discomfort on one end of the spectrum to extreme effects on the other.
NBC News spoke to 10 people about their experiences taking these blockbuster drugs, both of which are forms of semaglutide. They’re designed to mimic a hormone that signals to the brain when a person is full and promotes the release of insulin, a hormone that stops blood sugar from getting too high. In turn, the medications can lower blood sugar levels and suppress appetites.
They have soared in popularity over the last year, in part from social media attention and billionaires like Elon Musk touting the drugs’ weight loss effects.
Prescriptions for Ozempic tripled from 2021 to 2022, according to data from the prescription drug discount company SingleCare, which has more than 5 million members. Last year, high demand and global supply constraints gave rise to shortages of the medications. The FDA reported a Wegovy shortage in March 2022, followed by an Ozempic shortage in August.
Several people interviewed said the benefits they got from the drugs outweighed the side effects.
“It just feels lighter moving around. My clothes fit so much better and more comfortably,” said Stacey Bollinger, an account director in Maryland, who reported losing 52 pounds since starting Wegovy. “Something as simple as bending over to tie my shoe is so much easier.”
Some people said they felt fine on the medications. But Yazeed and a couple of others described side effects that forced them to stop taking the drugs or question whether they could stay on them long term.
Obesity medicine experts who prescribe Ozempic and Wegovy said the drugs can transform patients’ lives and health. The weight loss effects can enable patients to do activities they couldn’t do previously, like chase after grandchildren or find clothes that fit at mainstream stores. Semaglutide can also address health issues linked to obesity and diabetes, such as an elevated risk of heart attacks or stroke.
“By treating obesity, you’re effectively potentially treating over 200 other obesity-related or weight-related diseases,” said Dr. Ania Jastreboff, an associate professor of medicine at the Yale School of Medicine. Jastreboff serves on the scientific advisory board of Novo Nordisk, which makes Ozempic and Wegovy.
Accounts of dramatic weight loss
The Food and Drug Administration approved Ozempic for people with type 2 diabetes in 2017, then Wegovy — the same drug, which goes up to higher dosage — in 2021 for weight loss in adults with obesity or those who are overweight and have least one weight-related health condition, such as high blood pressure or cholesterol. Ozempic is not approved for weight loss, but doctors sometimes prescribe it off-label for that purpose.
Most people who took Ozempic or Wegovy said it curbed their hunger and reduced cravings for unhealthy food. Bollinger and Randi Lee Harper, a software developer in the Seattle area, each reported losing more than 50 pounds.
Harper took Ozempic off-label for weight loss from May until November (she paused while moving to Washington state but plans to start again). She said she still enjoyed her favorite foods — like truffle mac n’ cheese and Sour Patch Kids candy — but her portions were smaller.
“You don’t realize how much your life is centered around food when you’re overweight until you’re on a diet that just lets you not think about it so much, like on Ozempic,” Harper said.
For the most part, she added, she reacted well to the medication, though sometimes she burped if she ate too much — a fairly common side effect.
As for Bollinger, she said that in addition to her weight loss, her average blood sugar levels have dropped to a point where she’s no longer pre-diabetic.
A study of more than 1,000 people with type 2 diabetes found that semaglutide was more effective than insulin at lowering blood sugar. The participants had not seen results from other antidiabetic drugs, which they continued to take during the trial. In another study of nearly 2,000 overweight or obese adults without diabetes, people taking semaglutide lost an average of 34 pounds in less than 16 weeks, compared to 6 pounds among those receiving a placebo.
Dr. C. Nicole Swiner, a family medicine doctor in Durham, North Carolina, said she started taking Wegovy in 2021 after seeing how much it helped her patients. She has lost 30 pounds since then, she said.
“Because I’m not starving, I can actually stop and make a smarter decision [rather] than, ‘Oh my God, I’m ravenous. Let me grab whatever’s in the office kitchen,’ which is usually junk,” Swiner said.
On Wegovy, she added, she eats less overall and has swapped sugary treats like cookies or muffins for healthier alternatives like yogurt or fruit.
For Yazeed, weight loss was not the reason she went on Ozempic, nor was it a goal. But on the drug, she said, she had to force herself to eat and often couldn’t stomach anything beyond a protein shake in the morning. On a good day, she might also tolerate some chicken broth.
She lost 10 pounds in two months, going from a size 12 to an 8 or 10.
Patients who stop taking the drugs often regain weight
Like many drugs, the effects of semaglutide stop when patients go off of it, so some people regain weight. Experts said they consider Ozempic and Wegovy to be lifelong medications.
“Data from our clinical trials for Wegovy showed that, not unexpectedly, patients experience weight regain once they stop taking the medication,” Novo Nordisk told NBC News in a statement.
“This supports the belief that obesity is a chronic disease that requires long-term management, much like high blood pressure or high cholesterol, for which most patients remain on therapy long term,” the company added.
Ebony Wiggins, who has type 2 diabetes, said she has gained back about 15 pounds of the 25 she lost last year while taking Ozempic.
Artemis Bayandor, who lives in Naperville, Illinois, said she weighs more now than when she took Wegovy: Within one month of stopping the medication, she gained back the 15 pounds she had lost on the drug, she said, plus an extra 10 over the next six months.
“For the first week I was OK, and for the second week I went right back to all of the cravings, but worse,” Bayandor said.
Side effects put some people off the medications
Courtney Hamilton didn’t made it more than a month on Ozempic, which her doctor prescribed off-label because Hamilton has type 1 diabetes, not type 2.
Her nausea got so bad that she could barely eat, Hamilton said, and the foods she could tolerate weren’t particularly healthy.
“Ironically, it made me stick to very starchy, carby foods like potatoes because they’re very bland. I ate a lot of that and a lot of plain toast,” she said.
People typically start with a low dose of Ozempic or Wegovy, then ramp up to reduce side effects. Dr. Fatima Cody Stanford, an assistant professor of medicine at Massachusetts General Hospital, said some severe effects may be the result of raising that dosage too quickly.
“If the patient’s saying, ‘Oh gosh, I’m sick. I can’t even go to work, I’m vomiting all day,’ it’s probably the dose is just not an appropriate dose for them,” Stanford said.
In clinical trials, 73% of adults taking the highest dose of Wegovy reported gastrointestinal issues. Nausea, diarrhea, vomiting, constipation and stomach pain are most common. Some people have reported more serious, albeit rare, side effects like pancreatitis and kidney failure.
Novo Nordisk said patients experiencing nausea as a side effect should contact their health care provider for guidance about ways to manage it.
Jastreboff said she encourages her patients to consume smaller, more frequent meals, not eat past the point of fullness, and monitor which foods exacerbate their symptoms. Most side effects occur as people are increasing their dosage, then subside once they reach the maintenance phase, she added.
Megan Cornelius, who has been taking Ozempic off-label for type 1 diabetes for several years, said she was nauseous and fatigued at first but those effects faded over time.
“As long as I can continue to take it, I probably will,” Cornelius said.
For Eric Joiner Jr., a former type 2 diabetic, Ozempic hasn’t done anything beyond its intended effect: improve his kidney function — an off-label application of the drug. Joiner developed chronic kidney disease as a byproduct of his diabetes.
He hasn’t experienced side effects or weight loss from Ozempic, he said, but he recognizes that isn’t true for everyone.
“At the end of the day, it’s a very personal thing,” he said. “Your biology is different than mine.”
This story originally appeared on NBCNews.com.
This article was originally published on TODAY.com
‘Ozempic face?’ Dr. Siegel warns of popular diabetes drug’s bizarre side effect
It’s the weight loss drug people have dreamed of – or is it?
Diabetes drugs like semaglutide and tirzepatide have taken the medical community by storm, helping to not only keep certain endocrine disorders at bay, but also by showing promising signs of appetite control, improved insulin sensitivity, and, with both, weight loss. But the miraculous effects of the TikTok-famous Ozempic injections come at a cost.
“I spoke with some dermatologists about this yesterday,” Dr. Siegel said of “Ozempic face,” a bizarre side effect reported in Ozempic patients who claim the drug is making them look older. “It’s an overuse of the drug to where you lose weight too quickly. The buccal mucosa – the fat – leaves your face, and you become gaunt looking.”
OZEMPIC DIABETES DRUG IS TRENDING AS A WEIGHT-LOSS METHOD – HERE’S WHY AND WHAT DOCTORS SAY
Siegel warned Sunday on “Fox & Friends Weekend” that the side effect could possibly be irreversible.
Semaglutide injections have taken center stage amid the ever-lasting search for the immaculate weight loss solution.
(iStock)
“It’s something that happens to us anyway as we get older,” he explained.
OZEMPIC DRUG FACES SHORTAGE AFTER ENDORSEMENTS BY CELEBS
Reports of sagging skin, an older appearance and a “gaunt face” are now following the insanely popular “weight loss” injections, but Dr. Siegel still praised the drug for its potential to do great things.
“Ozempic is actually a great drug. It’s the first weight loss drug I’ve seen that I think really works,” he said. “It actually improves insulin, it improves getting rid of sugar, it decreases hunger…”
A diabetes patient prepares to administer an Ozempic injection in the stomach.
(iStock)
TikTok turned semaglutide injections like Ozempic into the latest weight loss craze for its alleged host of benefits, creating longstanding shortages and sparking debate surrounding whether patients should have off-label access to the drug.
Celebrities also took to the trend and spoke publicly about their use, creating an alarming recipe for ongoing shortages.
WEIGHT LOSS SECRETS FROM KIM KARDASHIAN, JESSICA SIMPSON AND MORE: EXPERT REVEALS WHAT NOT TO DO
Weight loss from diabetes drugs is becoming an increasingly common craze.
(Photo by Annette Riedl/picture alliance via Getty Images))
Since the popular drug became a namesake among the weight loss community, the FDA approved another stronger semaglutide injection and glucagon-like peptide agonist (GLP-1 agonist) for long-term weight loss named Wegovy.
The drug also saw shortages after demand skyrocketed last year.
In addition to concerns over “Ozempic face” and the older appearance it allegedly causes, experts have warned that the drugs can cause other, more serious side effects, including increased risk for rare forms of thyroid tumors, vision changes, kidney problems and gallbladder issues.
Rapid weight loss also poses health risks, potentially causing gallbladder issues, metabolic issues and hormonal imbalances.
Semaglutide and tirzepatide injections are also used to help treat or control other endocrine disorders such as insulin resistance or pre-diabetes and metabolic syndrome.
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Fox News’ Julia Musto contributed to this report.
Mindfulness exercises can be as effective as anxiety drugs, study shows
A seven-point scale was used to assess anxiety among 208 participants, with a score of seven representing extreme anxiety and a score of one being normal. In both the medication and the mindfulness groups, the average score after treatment dropped from a moderate level of anxiety to a mild level of anxiety.
Both groups began the study with similar baseline scores (4.44 in the mindfulness group and 4.51 in the medication group.) By the end of the study, anxiety scores in both groups had declined to an average of 3.09 on the anxiety scale, a statistically similar change that showed the treatments to be equally effective.
Mindfulness practices such as breathing exercises have been used to treat anxiety for a long time, but this is the first study showing how effective they can be in comparison with standard treatments for anxiety disorders, said the study’s lead author, Elizabeth Hoge, who is a psychiatrist and director of the Anxiety Disorders Research Program at Georgetown University.
She believes the findings help support the use of mindfulness as a viable intervention that may be better than traditional treatments for some people, such as those who aren’t comfortable seeing a psychiatrist or who experience negative side effects from medication.
“We can’t yet predict who will do better with which type of treatment,” Hoge said. “But there’s nothing that says you couldn’t do both at the same time.”
Breathing, body scans and mindful movement
Mindfulness treatments used in the study included breath awareness exercises, which involve paying attention to your breath as you allow thoughts to rise, then pass through your mind before letting them go. Importantly, the practice isn’t about trying to change your breath, Hoge said, but about focusing on your breath as a way to ground yourself if any anxious thoughts arise.
Participants also completed exercises such as a body scan, which involves paying attention to different parts of the body, and mindful movement, which includes stretching the body into different positions and noticing how each movement feels.
Those who received the eight-week mindfulness intervention attended a weekly 2.5-hour-long class with a mindfulness teacher, completed daily at-home exercises for 45 minutes, and attended a one-day mindfulness retreat five or six weeks into the course.
When anxiety becomes a habit
The reason mindfulness may help with anxiety is that it can interrupt a negative feedback loop in the brain, said Jud Brewer, director of research and innovation at Brown University’s Mindfulness Center and chief medical officer at Sharecare, a digital health company. Brewer believes that anxiety is a habit driven by negative reinforcement in the brain.
When we have a situation or thought that triggers our anxiety, worrying about it can feel rewarding in the brain, he said. “It can give people a sense of control even though they don’t have any more control than if they didn’t worry,” Brewer said.
Trying to stop worrying using willpower doesn’t work, he said, because it doesn’t change the way your brain works. But mindfulness can help train your brain to have new habits because it helps you to recognize that worrying is not rewarding and provides an alternative sense of control that feels better than worrying, Brewer said. He helped develop an app for mindfulness training called Unwinding Anxiety and in a small, randomized study, showed that using the app significantly reduced people’s anxiety.
How mindfulness can change the brain
Other studies have shown that practicing mindfulness can rewire the brain, leading to long-term changes in behavior and thinking, said Sara Lazar, an associate professor at Harvard Medical School.
In people who worry a lot, a part of the brain called the default mode network can become overactive, causing their minds to wander toward negative or anxious thoughts more often, Lazar said. But research shows that meditation and mindfulness exercises can help turn off this part of the brain and make it less active by training people to refocus, she explained.
Mindfulness training also has been shown to reduce activity in the amygdala, a part of the brain that helps regulate fear, stress and other emotions, she said. And, her research suggests that these types of changes can be long lasting.
“People who go through these programs, even if they discontinue, continue to report benefits months later,” Lazar said. “It’s like learning to ride a bike, even if you stop, you can do it again.”
Gripped by anxious thoughts
Julie Rose, 48, of Provo, Utah, decided to try mindfulness in 2018 when she realized that while medications helped with her anxiety, she needed additional coping strategies. She was finding it hard to focus at her job as a podcast host and had trouble sleeping. Her anxious thoughts “gripped” her, she said, and trying to control them by ignoring them or redirecting her anxious energy wasn’t helping.
She signed up for eight weeks of mindfulness classes. At first, she didn’t feel like the breathing or bodily awareness exercises were working — she still had anxious thoughts and felt like she couldn’t quiet them.
Then after a few weeks, she realized that though she couldn’t stop her anxious thoughts, with meditation, she could acknowledge them in a way that they passed more easily and quickly. On days that she meditated, she slept better and felt better overall, she said.
“I used to think this was stupid but it really works,” she said. “It allows the anxiety to keep on moving right on through me.”
How to practice mindfulness for anxiety
The more someone practices mindfulness, the more they will benefit, but even doing a few short exercises a few times a week can lessen anxiety, said Katherine Cullen, a licensed psychotherapist at Juniper Therapeutic Services in New York. While many studies on mindfulness involve a more significant time investment of over eight weeks, Cullen often suggests her patients start small with a simple breathing exercise for two minutes a few times a week.
She said that, at first, mindfulness exercises may feel uncomfortable, because people aren’t used to dealing with their emotions or anxious thoughts.
“Think of it like exercise. You might go for a walk after being inactive for a while and it might feel uncomfortable,” she said. “The key, like with exercise, is to be consistent about it.”
If someone is interested in trying mindfulness exercises, she advised they shouldn’t change their medications without consulting their prescribing physician or psychiatrist, and they should look for a practitioner or coach who is certified in Mindfulness Based Stress Reduction, which is an evidence-based form of mindfulness training. People can also try searching for centers affiliated with the nonprofit, Buddhist organization Insight Meditation Society, many of which offer donation-based mindfulness classes.
“If you’re new to mindfulness and have never done it before, I would strongly encourage you to do it with someone else,” Cullen said. “It’s really helpful to have someone there to actively guide you through it and answer any questions you might have.”
Houston patients struggle to find Ozempic as popularity for weight loss drugs skyrockets across social media
HOUSTON – The drug Semaglutide was initially marketed under the name Ozempic to manage type two diabetes. Last year, Semaglutide was approved by the FDA to be used for weight loss under the name Wegovy.
Social media has nicknamed them “skinny pens” because they help people drop significant weight quickly, leading to the popularity and a shortage of both Ozempic and Wegovy.
The drug manufacturer Novo Nordisk confirms it’s struggling to meet demand and Houston patients, like Lauren Luman, say she doesn’t know what she’ll do.
“I reached out to my doctor again letting them know that I was still experiencing that shortage, at that time they were able to give me some more samples, but they said, ‘We’re not sure how long we’re going to continue to have the samples available,’” Luman said.
Ozempic helped Luman lose weight and control her blood sugar. Now, she says she’s getting the same answer at every pharmacy she visits.
“It’s been weeks or months since they’ve had any supply,” Luman said.
Endocrinologists have said they’re frustrated patients cannot find their medication. However, endocrinologist Dr. Disha Narang, suggests there’s a need for successful weight loss drugs on the market.
“Our nation is, you know, there’s an epidemic of obesity as well and we need to treat the obesity to prevent diabetes in the first place,” Dr. Narang said.
Doctors are not doing anything wrong by prescribing Ozempic for obesity. According to the FDA, healthcare professionals can choose to prescribe drugs off-label when medically appropriate.
“Its intended use is for it to be an anti-diabetic prescription,” Luman said. “So, if people are taking it just for the sake of weight loss, I feel like maybe they should step back and allow the people that have type two diabetes and really need it to lower their A1C the ability to get this prescription.”
According to one study, the weight loss may return once the patient discontinues use.
Copyright 2023 by KPRC Click2Houston – All rights reserved.
70% of drugs advertised on TV are of “low therapeutic value,” study finds
Some new drugs sell themselves with impressive safety and efficacy data. For others, well, there are television commercials.
According to a new study, a little over 70 percent of prescription drugs advertised on television were rated as “low therapeutic value,” meaning they offer little benefit compared with drugs already on the market. The study, appearing in JAMA Open Network, aligns with longstanding skepticism that heavily promoted drugs have high therapeutic value.
“One explanation might be that drugs with substantial therapeutic value are likely to be recognized and prescribed without advertising, so manufacturers have greater incentive to promote drugs of lesser value,” said the authors, which include researchers at Harvard, Yale, and Dartmouth.
The US is one of only two countries that allow direct-to-consumer (DTC) drug advertisements, such as TV commercials. (The other is New Zealand.) Physicians, medical associations, and consumer advocates have long railed against the unusual practice. In 2006, consumer advocacy group Public Citizen summarized DTC advertising as “nothing less than an end-run around the doctor-patient relationship—an attempt to turn patients into the agents of pharmaceutical companies as they pressure physicians for medications they may not need.”
In 2015, the American Medical Association called for an all-out ban on DTC ads for prescription drugs and medical devices. AMA members said the ads were “driving demand for expensive treatments despite the clinical effectiveness of less costly alternatives.”
But DTC drug ads have continued, fueled by billions of dollars from the pharmaceutical industry.
Benefit not added
For the new study, researchers led by Aaron Kesselheim, who leads Harvard’s Program On Regulation, Therapeutics, And Law (PORTAL), looked at monthly lists of the top-advertised drugs on TV in the US between 2015 and 2021.
They also looked up therapeutic value ratings for those drugs from independent health assessment agencies in Canada, France, and Germany. The value ratings were based on drugs’ therapeutic benefit, safety profile, and strength of evidence, as compared with existing drugs. Any drug rating “moderate” or above was classified as a “high value” drug for the study. For drugs with multiple ratings, the study authors used the most favorable rating, which the authors note could overestimate the proportion of higher-benefit drugs.
Of the top advertised drugs, 73 had at least one value rating. Collectively, pharmaceutical companies spent $22.3 billion on advertising for those 73 drugs between 2015 and 2021. Even with the generous ratings, 53 of the 73 drugs (roughly 73 percent) were categorized as low-benefit. Collectively, these low-benefit drugs accounted for $15.9 billion of the ad spending. The top three low-benefit drugs by dollar amount were Dulaglutide (type 2 diabetes), Varenicline (smoking cessation), and Tofacitinib (rheumatoid arthritis).
The outlook for change is bleak, the authors note. “Policy makers and regulators could consider limiting direct-to-consumer advertising to drugs with high therapeutic or public health value or requiring standardized disclosure of comparative effectiveness and safety data,” Kesselheim and his colleagues concluded, “but policy changes would likely require industry cooperation or face constitutional challenge.”
Experts Recommend Drugs, Surgery for Teen Obesity in New Guidelines
For the first time ever, experts with the American Academy of Pediatrics are recommending proactive medical intervention against childhood obesity. The organization’s new guidelines will no longer ask doctors to simply observe or delay treatment in children with obesity, defined as a body mass index over 30. They instead now emphasize a range of options, such as dietary and lifestyle counseling for younger children as well as medications and/or surgery for children 12 and over.
Past standards for treating childhood obesity have called for “watchful waiting,” the hope being that a child’s BMI (a measure of both weight and height) would naturally lower over time as they grew. In 2007, the AAP’s previous recommendations promoted a step-based approach, where doctors might slowly escalate from observation to treatment. But these new recommendations—released Monday—are the first clinical practice guidelines to put obesity treatments front and center.
“There is no evidence that ‘watchful waiting’ or delayed treatment is appropriate for children with obesity,” said Sandra Hassink, one of the authors behind the guidelines and vice chair of the AAP Clinical Practice Guideline Subcommittee on Obesity, in a statement released by the organization. “The goal is to help patients make changes in lifestyle, behaviors or environment in a way that is sustainable and involves families in decision-making at every step of the way.”
The lengthy guidelines outline a multitude of available treatments, depending on a child’s age and other circumstances (children under 2 are not considered eligible for obesity treatment).
For younger children, these options can include intensive health behavior and lifestyle treatment, which can involve regular counseling sessions with the child and family over a 3- to 12-month period. For children 12 and over, doctors are now advised to consider medications as a front-line option. And teens 13 and over can also be evaluated for bariatric surgery as a potential treatment.
In crafting its recommendations, the AAP cites many studies suggesting that the benefits of these treatments outweigh any potential risks they can carry. Patients who have undergone bariatric surgery seem to have a lower risk of developing obesity-related complications such as type 2 diabetes and have a longer life expectancy when compared to non-surgical patients matched in age and baseline BMI, for instance. Long-term health benefits have been seen in teen bariatric patients specifically, too.
A new class of medication, called incretins, has also greatly changed the landscape of obesity treatment in recent years. These drugs, combined with diet and exercise, have led to far larger weight loss on average than most other treatments and are approaching the typical results seen with bariatric surgery.
Last month, the Food and Drug Administration extended the approval of Novo Nordisk’s Wegovy, the first drug of this new generation, to children over 12, following clinical trial data showing that teens saw a similar improvement in BMI as adults. The shortages that have plagued Wegovy’s rollout since its approval in June 2021 may finally be over as well, with the company recently announcing that its supply should now be stable. Without insurance coverage, which is often limited, the drug can still cost over $1,000 a month, however.
The AAP’s guidelines arrive at a time when the rise in U.S. obesity rates, including among children, has only accelerated, likely in part due to the covid-19 pandemic. The new recommendations notably do not cover how best to prevent obesity in children, though the organization has promised to release separate recommendations for that in the near future.
“The medical costs of obesity on children, families and our society as a whole are well-documented and require urgent action,” said lead author Sarah Hampl in a statement. “This is a complex issue, but there are multiple ways we can take steps to intervene now and help children and teens build the foundation for a long, healthy life.”
Pediatricians now recommend drugs and surgery for kids with obesity
Children as young as 12 with obesity should now consider taking weight loss drugs, and those as young as 13 with severe obesity should consider metabolic or bariatric surgery, according to aggressive new guidelines released Monday by the American Academy of Pediatrics.
The new guidance marks the first time the AAP has recommended weight loss drugs for childhood obesity. Overall, the medical group is urging immediate, intensive action to get ahead of childhood obesity and overweight before the complex conditions lead to long-term health problems, such as cardiovascular disease and diabetes.
“There is no evidence that ‘watchful waiting’ or delayed treatment is appropriate for children with obesity,” said Sandra Hassink, an author of the guideline and vice chair of the AAP’s Clinical Practice Guideline Subcommittee on Obesity, said in a statement. “The goal is to help patients make changes in lifestyle, behaviors, or environment in a way that is sustainable and involves families in decision-making at every step of the way.”
Obesity and overweight have long been stigmatized as simple conditions driven by personal choices. But in reality, the AAP points out, they are complex medical conditions that involve combinations of genetic, physiologic, socioeconomic, and environmental factors.
“Weight is a sensitive topic for most of us, and children and teens are especially aware of the harsh and unfair stigma that comes with being affected by it,” said Sarah Hampl, MD, a lead author of the guideline, said in a statement. “Research tells us that we need to take a close look at families—where they live, their access to nutritious food, health care, and opportunities for physical activity—as well as other factors that are associated with health, quality-of-life outcomes and risks.”
The AAP defines the condition of overweight as having a body-mass index (BMI) at or above the 85th percentile to 95th percentile. Obesity is defined as having a BMI at or above the 95th percentile, and severe obesity is defined by a BMI at or above 120 percent of the 95th percentile for age and sex.
In addition to recommendations related to weight-loss medications for obesity and surgery for severe obesity, the guidance includes recommendations for motivational interviewing and intensive health behavior and lifestyle treatment. The AAP also recommends that pediatricians evaluate children with overweight, obesity, and severe obesity for lipid abnormalities, high blood pressure, signs of pre-diabetes or diabetes, and mental health conditions. The guidance discusses the increased risk children face due to special health needs, low socioeconomic status, and structural racism.
Last month, the US Centers for Disease Control and Prevention extended the growth charts for children and adolescents (aged 2 to 19 years) to track growth and treatment of children with severe obesity.
“Childhood obesity is a serious and increasing problem in the United States,” Karen Hacker, director of the CDC’s National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), said in a statement at the time. “The Extended BMI-for-Age Growth Charts allow clinicians to track growth and visualize high BMI percentiles with families.”
Before the pandemic, obesity affected about 14.7 million children and adolescents. The pandemic made things worse. According to a CDC study published in 2021, the rate that BMIs in children and adolescents were increasing doubled during the pandemic compared with pre-pandemic years. Those most affected by the increase were children and teens with overweight or obesity, and younger school-aged children.
New guidance: Use drugs, surgery early for obesity in kids
Children struggling with obesity should be evaluated and treated early and aggressively, including with medications for kids as young as 12 and surgery for those as young as 13, according to new guidelines released Monday.
The longstanding practice of “watchful waiting,” or delaying treatment to see whether children and teens outgrow or overcome obesity on their own only worsens the problem that affects more than 14.4 million young people in the U.S. Left untreated, obesity can lead to lifelong health problems, including high blood pressure, diabetes and depression.
“Waiting doesn’t work,” said Dr. Ihuoma Eneli, co-author of the first guidance on childhood obesity in 15 years from the American Academy of Pediatrics. “What we see is a continuation of weight gain and the likelihood that they’ll have (obesity) in adulthood.”
For the first time, the group’s guidance sets ages at which kids and teens should be offered medical treatments such as drugs and surgery — in addition to intensive diet, exercise and other behavior and lifestyle interventions, said Eneli, director of the Center for Healthy Weight and Nutrition at Nationwide Children’s Hospital.
In general, doctors should offer adolescents 12 and older who have obesity access to appropriate drugs and teens 13 and older with severe obesity referrals for weight-loss surgery, though situations may vary.
The guidelines aim to reset the inaccurate view of obesity as “a personal problem, maybe a failure of the person’s diligence,” said Dr. Sandra Hassink, medical director for the AAP Institute for Healthy Childhood weight, and a co-author of the guidelines.
“This is not different than you have asthma and now we have an inhaler for you,” Hassink said.
Young people who have a body mass index that meets or exceeds the 95th percentile for kids of the same age and gender are considered obese. Kids who reach or exceed the 120th percentile are considered to have severe obesity. BMI is a measure of body size based on a calculation of height and weight.
Obesity affects nearly 20% of kids and teens in the U.S. and about 42% of adults, according to the Centers for Disease Control and Prevention.
The group’s guidance takes into consideration that obesity is a biological problem and that the condition is a complex, chronic disease, said Aaron Kelly, co-director of the Center for Pediatric Obesity Medicine at the University of Minnesota.
“Obesity is not a lifestyle problem. It is not a lifestyle disease,” he said. “It predominately emerges from biological factors.”
The guidelines come as new drug treatments for obesity in kids have emerged, including approval late last month of Wegovy, a weekly injection, for use in children ages 12 and older. Different doses of the drug, called semaglutide, are also used under different names to treat diabetes. A recent study published in the New England Journal of Medicine found that Wegovy, made by Novo Nordisk, helped teens reduce their BMI by about 16% on average, better than the results in adults.
Within days of the Dec. 23 authorization, pediatrician Dr. Claudia Fox had prescribed the drug for one of her patients, a 12-year-old girl.
“What it offers patients is the possibility of even having an almost normal body mass index,” said Fox, also a weight management specialist at the University of Minnesota. “It’s like a whole different level of improvement.”
The drug affects how the pathways between the brain and the gut regulate energy, said Dr. Justin Ryder, an obesity researcher at Lurie Children’s Hospital in Chicago.
“It works on how your brain and stomach communicate with one another and helps you feel more full than you would be,” he said.
Still, specific doses of semaglutide and other anti-obesity drugs have been hard to get because of recent shortages caused by manufacturing problems and high demand, spurred in part by celebrities on TikTok and other social media platforms boasting about enhanced weight loss.
In addition, many insurers won’t pay for the medication, which costs about $1,300 a month. “I sent the prescription yesterday,” Fox said. “I’m not holding my breath that insurance will cover it.”
One expert in pediatric obesity cautioned that while kids with obesity must be treated early and intensively, he worries that some doctors may turn too quickly to drugs or surgery.
“It’s not that I’m against the medications,” said Dr. Robert Lustig, a longtime specialist in pediatric endocrinology at the University of California, San Francisco. “I’m against the willy-nilly use of those medications without addressing the cause of the problem.”
Lustig said children must be evaluated individually to understand all of the factors that contribute to obesity. He has long blamed too much sugar for the rise in obesity. He urges a sharp focus on diet, particularly ultraprocessed foods that are high in sugar and low in fiber.
Dr. Stephanie Byrne, a pediatrician at Cedars Sinai Medical Center in Los Angeles, said she’d like more research about the drug’s efficacy in a more diverse group of children and about potential long-term effects before she begins prescribing it regularly.
“I would want to see it be used on a little more consistent basis,” she said. “And I would have to have that patient come in pretty frequently to be monitored.”
At the same time, she welcomed the group’s new emphasis on prompt, intensive treatment for obesity in kids.
“I definitely think this is a realization that diet and exercise is not going to do it for a number of teens who are struggling with this – maybe the majority,” she said.
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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content.