April 21, 2023 — First, celebrities sparked controversy after reports claimed they were using the diabetes medication Ozempic, taking the hunger-taming injection off-label and potentially jeopardizing the supply for those with diabetes. Now, some commercial weight loss programs that have long advocated a laser focus on diet, exercise, and behavior change are adding prescription weight loss drugs approved to treat obesity, such as Wegovy. And that’s triggering a healthy debate.
WW, formerly called Weight Watchers, and Noom are fine-tuning special programs, not yet available, that will incorporate the prescription weight loss drugs for those with a substantial amount of weight to lose.
Offering the medications within a structured program of diet and exercise, advocates say, is following science, increases the chance of long-term success, and acknowledges that obesity is a chronic disease that requires chronic treatment.
Skeptics admit the promise of the new medications but wonder if adding them is more about boosting a company’s bottom line in a competitive market. They point to other obstacles, such as the costs of the pricey medications, spotty insurance coverage, and the potential for side effects.
Already, online options to buy the medications abound, ranging from sites touting a 15-minute doctor consult — an approach that worries some obesity medicine doctors — to a platform from Novo Nordisk, the maker of the weight loss medicine Wegovy, that offers the medicine plus online support.
The New Weight Loss Crop
Interest in prescription weight loss medications rose with the approval of new drugs in recent years known as GLP-1s because they mimic the effects of glucagon-like peptide 1, a hormone made in the gut that helps people feel full.
“These medications deserve the title ‘second generation’ obesity medicines,” said W. Timothy Garvey, MD, associate director and professor of nutrition sciences at the University of Alabama at Birmingham and a longtime obesity researcher.
The FDA approved Wegovy (semaglutide) in June 2021 after the largest clinical trial found those without diabetes who took it lost an average of 12.4% of their body weight. It had previously approved semaglutide as Ozempic for type 2 diabetes in December 2017. Those taking the medication for diabetes control had better blood sugar but also lost weight.
While both drugs are the same medication, and both rely on weekly injections, they have different dosing schedules — with Wegovy available in higher dosages. The drugs are not interchangeable. Ozempic’s approval is for treatment of type 2 diabetes, but it is often prescribed “off-label” for weight loss. Wegovy is approved for those with a body mass index or BMI of 30 (a person 5’9″ weighing 203) or someone with a BMI of 27 who has weight-related medical problems such as high blood pressure. There is also a tablet version of semaglutide called Rybelsus that is only approved for type 2 diabetes but is also being used off-label for weight loss.
Garvey and his colleagues studied the effects of weekly injections of 2.4 milligrams of semaglutide in adults with obesity or overweight but without diabetes. At the end of 2 years, the average weight loss was 15.2% overall.
Another drug from Eli Lilly, tirzepatide, not yet approved for weight loss, may produce even better results. Already approved as Mounjaro for type 2 diabetes, tirzepatide, which is also in the GLP-1 class of drugs like semaglutide, has been fast-tracked for approval for weight management, according to the company.
In a clinical trial to study it for obesity, those taking the highest dose lost nearly 21% or more of their body weight at week 72. It works by helping people feel full, in the same way that Wegovy does, and also by slowing how fast food moves through the digestive tract.
As promising as the results are, the drugs are pricey. According to Allison Schneider, a Novo Nordisk spokesperson, the list price for Wegovy is $1,349.02 for a 28-day supply of four pens, injected once a week. Obesity experts say insurance coverage is not common, but Schneider said it is improving, with 40 million patients in the U.S. having some coverage for obesity medicines.
Side effects include nausea, vomiting, diarrhea, and constipation, among others.
Commercial Weight Loss Programs
In March, WW announced it had acquired Sequence, an online telehealth platform offering access to prescription weight loss medications through health care providers specializing in chronic weight management. The deal closed April 10, and the next day the stock price of of WW’s parent company surged by 60%.
Now, WW is developing a special program for those who are eligible for the weight loss medications, according to Gary Foster, PhD, WW’s chief scientific officer and an adjunct professor of psychology at the University of Pennsylvania’s Perelman School of Medicine in Philadelphia.
Research suggests that those taking the weight loss medications may need to eat more protein and may need to do more resistance training than those not on them, he said, explaining that they may need to adjust their diet, too, as the “food noise” declines when people are on the new weight loss medications.
The shift in direction “is not a left turn,” Foster said, but a question of keeping up with science on the new medications. “I’ve been in the business for 30 years, and I have never seen anything that represents such an inflection point.”
Foster couldn’t give a firm date for when the new program will be available, but he said “it will be months, not years.” Those interested in the new program are invited to add their names to the wait list on the website. Foster declined to say how many have signed up.
Sequence, which remains open to others, including those on WW, charges $49 for an initial consult, then a $99 monthly membership fee. The company works with members to “maximize” insurance coverage of the medications.
At a Los Angeles area WW studio one morning in mid-April, no posters or fliers described the program, despite the website invitation to join a wait list. Asked about the program, an employee (who asked to remain unnamed) who was checking in members for their meeting said that wasn’t a WW program, that WW “doesn’t push drugs.”
Noom is an existing online platform offering help with health and wellness, including weight loss. It is also testing a program called Noom Clinical, according to a statement from a company spokesperson. After an evaluation by a trained clinician, users who meet the criteria can ask about getting a weight loss medication.
The pilot program began in fall 2022 and is only available to a small group. No other details were offered.
The monthly cost for Noom’s standard weight loss program starts at $70.
Obesity Doctors View
Obesity is “a disease that deserves treatment,” said Garvey of the University of Alabama at Birmingham.
It’s both difficult and expensive to treat, and it’s crucial for a doctor to evaluate a patient before prescribing the medications, he said. “If you don’t evaluate the patient, you could be missing life-threatening things, obesity-related disease, such as cardiovascular disease, diabetes, sleep apnea.”
While an evaluation by a doctor is needed, many aren’t familiar with obesity treatment, as they didn’t learn about obesity medicine in medical school years ago, Garvey said. He sees a role for telemedicine but said there should also be a face-to-face exam with lab tests to thoroughly evaluate the person.
Mitul Desai, MD, an internist and obesity medicine specialist in suburban Chicago, also has concerns about an online health care provider prescribing medications to patients they have never seen.
“Someone trained in obesity medicine can tailor the program to the individual patient,” she said. Like other obesity specialists, she has a team of other health care providers who could manage the other aspects of weight loss.
“I would not send them to WW,” Desai said. “I would manage the behavioral aspects.” She works with a nutritionist, a health coach, and others.
Sequence gives users the opportunity to share information with their doctors.
Mixed Reactions
Some who have followed the “eat less, move more” mentality for years with success aren’t convinced that prescription medications are the way to go. When asked about the new WW option, Rebecca, an education professor in Los Angeles who recently lost weight by ramping up her exercise and eating better, snapped: “That’s cheating!”
Donna, who asked that her last name not be used, is a former WW member in upstate New York who gained “lifetime” status — the designation after a member has reached goal weight and maintained that loss. She is not a fan of the new approach. “I’ve maintained a loss of 150 plus pounds,” she said. And she did it the old-fashioned way. Weight loss drugs, in her opinion, should be prescribed by a person’s own doctor, not a weight loss program.
Janise Escobar, 66, a social worker in the Los Angeles area, sees it differently. She follows the WW program and is near her goal weight. “I’m not going to use it,” she said of the new medication. But she can see how it might help people and prefers not to be judgmental.
Boosting Profits?
“The weight loss market is very fragmented and very competitive,” said John LaRosa, research director at Marketdata LLC, a market research firm in Tampa, FL, that has tracked the weight loss market since 1989. “There are so many more competitors than 10 or 20 years ago.”
Besides the commercial weight loss plans, he said, there are programs run by independent doctors (including bariatricians who specialize in weight control without surgical intervention and have prescribed medications for years), hospital-based programs, very low-calorie plans such as Optifast and Medifast, and bariatric surgery.
The current focus on weight loss drugs, he said, may be counterproductive and represent false hope, LaRosa said. But for the companies, it may be good for the bottom line. “For WW in particular, their revenue and subscriptions have been declining for a couple of years. I think they are looking for something to boost them back into a growth mode.”
The pandemic was tough on programs like WW, which traditionally emphasized in-person meetings and had to pivot to virtual meetings quickly when the pandemic shutdown began in 2020.
Hoping History Won’t Repeat
While the initial research on the new diet drugs shows good results, LaRosa had concerns. He remembers the fallout in 1997, when Mayo Clinic experts first sounded the alarm about the drug combination known as fen-phen after reports surfaced about heart valve damage and concerns about high blood pressure. Some commercial weight loss programs, including NutriSystem and Jenny Craig, had offered the medications.
Fenfluramine was withdrawn from the market in September 1997. It’s now approved as Fintepla to treat seizures but tightly controlled. Phentermine is still on the market, combined with topiramate and known as Qsymia.
The other issue, of course, is cost. Without coverage, LaRosa asks, “how long can consumers afford to pay $1,300 a month for a weight loss drug?”
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2023-04-21 21:05:17
