New Weight Loss Treatment Is Marked by Heavy Marketing and Modest Results – Kaiser Health News

By Julie Appleby June 22, 2022

First came the “edible billboard,” which appeared last year during the holidays in New York’s East Village loaded with cake treats. Then, in late January, came the national marketing campaign, with TV and digital media promoting the idea that trying to lose weight doesn’t mean a person can’t enjoy eating.

Those advertising messages are pushing a product named Plenity as a potential liberation from dieters’ woes. It’s a $98-a-month weight loss treatment that looks like a drug: Patients take three capsules twice a day. But it isn’t a drug. And its success in racking up lost pounds, on average, is modest.

Plenity is FDA-approved as a device, one that contains sugar-sized grains of a plant-based, absorbent hydrogel. Each grain swells to 100 times its size, cumulatively filling about a quarter of a person’s stomach. The three capsules containing them must be taken with two cups of water at least 20 minutes before eating. The gel is not absorbed and eventually exits the body in stool.

The treatment is also generally not covered by insurance.

“We thought we would price it low enough that most consumers can pay out-of-pocket,” said Dr. Harry Leider, chief medical officer and executive vice president of Gelesis, the maker of Plenity.

Although far less costly than some other prescription weight loss treatments, it still “isn’t affordable for someone in the low-income bracket,” said Jena Shaw Tronieri, an assistant professor and director of clinical services at the University of Pennsylvania’s Center for Weight and Eating Disorders.

Plenity is designed to help patients who want to eat less, and taking it is comparable to consuming a big salad before lunch and dinner, without the actual raw vegetables.

It joins a growing selection of prescription weight loss and obesity treatments, from old-school oral medications that are often low-cost generics to far pricier brand-name injectable diabetes drugs newly repurposed as weight loss treatments. Results varied widely among trial participants; 59% of those who got Plenity lost at least 5% of their body weight, although the rest did not meet that threshold.

Plenity, whose active ingredient is a form of cellulose, embraces a strategy that has been used for decades by some people: to feel full before eating a main meal, thus reducing the calories they take in. Studies have shown that “if you fill up on broth-based soup or vegetables before a meal, you will feel fuller and eat less,” said Tronieri. She noted that filling up with water doesn’t produce the same satiating effect.

Still, some patients say that they “hate vegetables” and that “capsules are a lot easier,” said Dr. Christina Nguyen, medical director of obesity medicine at Northeast Georgia Health System. She is not affiliated with Gelesis but has been prescribing Plenity since its soft launch in late 2020.

So far, Gelesis credits the marketing campaign with helping it pick up 40,000 new customers in the first three months of the year, adding $7.5 million in revenue, although the company still lost money in the first quarter.

So where does this latest treatment fit as a potential weight loss tool for the more than 70% of American adults who are overweight or obese?

“I’m glad to see it on the market, but I tend to want more weight loss in patients than what I’m looking at with this device,” said W. Timothy Garvey, professor at the University of Alabama at Birmingham and director of the university’s Diabetes Research Center.

Gelesis reported that participants in its clinical trial who used Plenity lost on average 6.4% of body weight — above the 5% that many physicians say is a good target threshold. For a 200-pound person, that would equal almost 13 pounds. Still, that’s only a bit better than the 4.4% weight loss, on average, that people given a placeboin the six-month trial experienced. All 436 participants were put on diets that averaged 300 calories a day less than they needed to maintain their weight.

Nguyen said she tells her patients they must change their eating and exercise habits or Plenity won’t work. “You have to be realistic and set expectations,” she said. “What I’ve seen with Plenity is weight loss of about 5%.”

She noted it has relatively few side effects — mainly gastrointestinal, such as bloating, nausea, constipation, or flatulence — and the FDA has approved it for use in people with lower body mass index numbers than required for many other prescription products.

Plenity’s average weight loss is comparable to or below that of some other oral medications and is far less than that of the much more expensive new additions to the market such as Novo Nordisk’s Wegovy, a once-a-week injection that costs $1,300 a month. Wegovy helped patients lose nearly 15% of their body weight over 17 months, on average, according to clinical trials. In April, Eli Lilly said an injectable drug it is testing helped patients achieve an average weight loss of 22.5%. More details were released June 4.

“We don’t see Wegovy as a competitor,” said Leider, of Gelesis.

Nor does Leider view the weight loss products available without a prescription as competitors.

Leider said Gelesis sought FDA prescription approval for the treatment, rather than over-the-counter status, because “there’s a whole wall of nutritional supplements and products” and “we felt it was absolutely important to do the study and prove it scientifically works.” Down the road, “once we’ve built the brand,” Gelesis could seek over-the-counter status, he added.

As with other treatments, weight loss with Plenity can vary widely, he noted. Study data shows 27% of those given the treatment were considered “super responders,” losing an average of 14% of their weight. Patients with diabetes or prediabetes may respond better than those with normal blood sugar levels.

Still, it didn’t work for 40% of participants in the trial.

“If you take it for two months and you’re not losing weight, it may not be the therapy for you,” Leider said.

Patients can request Plenity from their physicians. In a move aimed at setting it apart from other treatments, Gelesis offers potential patients another choice: skipping an in-office visit entirely by requesting the treatment online. It has partnered with Ro, a direct-to-patient platform, which provides its network of affiliated physicians for online health assessments and delivers the treatment to eligible customers. Ro is also alarge purchaser of Plenity, placing a $30 million prepaid order in late 2021.

Ro, originally named Roman, launched in 2017 and initially focused on men’s health concerns, including erectile dysfunction and hair loss. It has since expanded to cover other conditions.

Online visits with physicians through Ro are free, including those for weight loss. Patients must answer questions about their health and experiences trying to lose weight.Pregnant patients, people younger than 22, and those allergic to Plenity’s ingredients should not take it.

Information provided to Ro is not protected under the federal privacy law called the Health Insurance Portability and Accountability Act, or HIPAA, but CEO Zachariah Reitano said all data is stored in “HIPAA-compliant” ways.

Ro added Plenity to its offerings because of the clinical trial results and because it saw a business opportunity with weight loss. Help for “challenges with weight management” was one of the top items his customers requested, Reitano said.

Even though it’s not covered by his insurance plan, patient Rene Morales said the $98 a month he spends is worth it. “If I spend that [much] on coffee, I can spend it to benefit my health,” said the 51-year-old, who is president of a skateboard company in Montclair, California, and was made available for an interview by Gelesis.

He started taking Plenity in late January after his doctor brought it up during his annual physical. Morales said he has lost 15 pounds from his original weight of nearly 280 pounds and wants to stay on the treatment until he has dropped 30.

Morales said the treatment is also helping him reshape his view of food and focus on smaller portions: “I’ve come to [the] realization that you don’t have to pile your plate up to enjoy your food.”

KHN (Kaiser Health News) is a national newsroom that produces in-depth journalism about health issues. Together with Policy Analysis and Polling, KHN is one of the three major operating programs at KFF (Kaiser Family Foundation). KFF is an endowed nonprofit organization providing information on health issues to the nation.

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Stay as Thin as You Can as Long as You Can

Based on the evidence from clinical trials weight loss (typically 15 kg or greater) is the main driver and predictor of remission.

Dietary strategies for remission of type 2 diabetes: A narrative review — https://doi.org/10.1111/jhn.12938

A weight loss program can lead to type 2 diabetes remission, even in individuals with a normal body mass index (BMI), via loss of body fat, particularly in the liver and pancreas, shows a UK study.

Type 2 Diabetes Remission Possible For Those With Lower BMI — https://www.medscape.com/viewarticle/971599?src=rss#vp_1

The title of this post is a direct quote from an Endocrinologist who at the time was practicing in Dallas Texas. I asked if he had any advice for me to reduce my risk of developing diabetes.

“Stay as thin as you can as long as you can.”

These words have stuck with me ever since.

New study shows dietary self-monitoring takes less than 15 minutes a day

Dietary self-monitoring is the best predictor of weight-loss success. But the practice is viewed as so unpleasant and time-consuming, many would-be weight-losers won’t adopt it. New research shows for the first time how little time it actually takes: 14.6 minutes per day on average. The frequency of monitoring, not the time spent on the process, was the key factor for those in the study who successfully lost weight.

I continuously self-monitor using estimates of calories in my head.  I have used online resources in the past which were useful.

Read the source article at this link.

Daily Weighing may be Key to Losing Weight

Researchers identified several categories of self-weighing adults, from those that weighed themselves daily or almost daily to adults who never used at-home scales.

They found that people who never weighed themselves or only weighed once a week did not lose weight in the following year. Those that weighed themselves six to seven times a week had a significant weight loss (1.7 percent) in 12 months.

Link to source article.

184.4

Yes, I weigh myself almost every day.

Yes it’s been over 40 years since I lost 200 pounds.

Yes!

To Weigh or Not to Weigh

The National Weight Control Registry has published several studies on the habits of those who have successfully achieved and maintained significant weight loss over 10 years (4, 5, 6, 7). Their findings are based on the tracking of over 10,000 individuals through detailed questionnaires and annual follow-up surveys designed to identify behavioral and psychological characteristics and strategies used to maintain weight loss. 75% weigh themselves at least once a week.

Here’s a short literature review on weighing habits in the processes of losing weight and maintaining weight loss.  Read the source article here.

I completed my annual National Weight Control Registry survey this morning.

For the first time in a very long time I reported a weight loss since the last follow up.

When I tell people I’ve lost 200 pounds they are always surprised and ask how I did it.

Well, you’ll just have to buy the book when I finish writing it.

Scientists identify weight loss ripple effect

That’s the finding of a new University of Connecticut study that tracked the weight loss progress of 130 couples over six months. The researchers found that when one member of a couple commits to losing weight, the chances were good the other partner would lose some weight too, even if they were not actively participating in a weight loss intervention.

The study’s lead investigator, UConn Professor Amy Gorin, calls it a “ripple effect.”

“When one person changes their behavior, the people around them change,” says Gorin, a behavioral psychologist. “Whether the patient works with their healthcare provider, joins a community-based, lifestyle approach like Weight Watchers, or tries to lose weight on their own, their new healthy behaviors can benefit others in their lives.”

The study, published in the peer-reviewed medical journal Obesity, also found that the rate at which couples lose weight is interlinked. In other words, if one member lost weight at a steady pace, their partner did too. Likewise, if one person struggled to lose weight, their partner also struggled.

Read the entire source article here.

I wonder if there is a multiplier effect if you only associate with others trying to lose weight?  My 200 pound weight loss was done on the buddy system with my girlfriend.  It was a long time ago but between the two of us the total combined weight loss was over 250 pounds.

The weight loss was a good thing but it didn’t help our relationship.

 

Alcoholism after gastric bypass: Is it in your mind or gut? » Scienceline

In 2012, a large study published in the Journal of the American Medical Association reported that the percentage of patients abusing alcohol increased from 7.6 percent before surgery to 9.6 percent two years after surgery — that’s potentially an additional 2,000 alcoholics each year in the United States. Since then, a growing body of evidence has corroborated these findings. The longest-running study suggests the effect persists even a decade after surgery.

via Alcoholism after gastric bypass: Is it in your mind or gut? » Scienceline.

Stupidity is Worse for us than Either Sugar or Saturated Fat

Stupidity is worse for us than either sugar or saturated fat.

Read this article and you’ll encounter a well reasoned rant with lots of links for further reading enjoyment.  My personal journey includes a significant weight loss experience in my early 20’s.  Over the years I’ve gained back some of the 200 plus pounds lost.  Over the years I’ve also gotten lazy with my dietary habits.  Too many calories and an aging metabolism is not a combination for staying trim.  So I got serious (again) and have dropped 12 pounds the past three months.  I’ve always known what to do but failed to do what needed to be done.

And so it goes.  Change. Adapt. Repeat.