Weight Loss Drugs Part 2 - Plenity and Alli

Weight Loss Drugs - A Long Line of Losers

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In part one we talked about some diet drugs that were part of the history of approving and prescribing dangerous drugs to fat people based on short-term data, and generating massive profit until the harm to fat people reaches a threshold that causes the drug to be pulled from the market. Today we’ll talk about a couple current drugs that seem like they might be on their way to joining that history.

Plenity

 I don’t know about you, but I have seen ads for Plenity all over my social media. Since I knew it was a capsule, I assumed it was a drug. However, when I looked into it, I learned that it is considered a “device.” It is “FDA cleared” as an “ingested, transient, space-occupying device for weight management and/or weight loss.”

Note that FDA clearance doesn’t, in any way, mean that it actually works, just that they have cleared it for safety. Plenity was given a Class II designation, meaning that it poses a moderate to high risk to the patient and/or user. This is the designation of most medical devices.

It turns out that it is a gelatin capsule filled with thousands of salt-grain-sized hydrogel particles (made of cellulose and citric acid). One takes three of these capsules and then drinks at least 16 ounces of water. The water mixes with the hydrogel to form “a three-dimensional matrix designed to occupy volume in the stomach and small intestine, to create a sensation of fullness.”  Each of the particles can hydrate up to 100 times its original weight. It travels through the digestive system until it is broken down in the colon, the water is re-absorbed and the Plentity particles pass through undigested, and are eliminated through bowel movements.

So the idea is to fool your body into thinking you have eaten more food that you have. This is, of course, predicated on the stereotype that fat people eat more food than they need. If a fat person doesn’t fit this stereotype, then the use of Plenity can lead to undernourishment since the person will no longer be able to trust their body’s sense of fullness. It could also create or exacerbate an eating disorder.

The FDA clearance was based on a 24-week (otherwise known as 5-month) study. They started with 223 people, 51 dropped out during the visit stage. Another 22 dropped out during follow-up, leaving just 150 at the end.

Those who made it through the trial lost an average of 6.4% of body weight. Those on a placebo averaged 4.4% weight loss on Placebo (this was below the study’s own threshold for “success” of 3% greater than a placebo.)

There is absolutely no long-term research to suggest that this won’t have the same outcome that decades of research tell us it will – that everyone will end up regaining all the weight they lost.

Meanwhile, there are risks. If not taken carefully, Plenity can interrupt absorption of medication. Taken as directed it can cause diarrhea, distended abdomen, infrequent bowel movements, and flatulence. It can also be harmful for those with a history of heartburn, ulcers or gastroesophageal reflux disease (GERD) and there is a paucity of data on the impact to gut health.

The cost for Plenity is $1.75/meal or $1916.25/year. To put this in perspective in the five-month study the average 200-pound person would have lost 4 pounds more than with the placebo, at a cost of about $199 per pound.

Alli/Xenical/Orlistat

This is an over-the-counter medication that blocks the absorption of about 25% of fat in the foods you eat

Their claim is that “Alli, along with a reduced-calorie, low-fat diet, can result in a 5% to 10% weight loss over time.”

It was initially approved based on a 6-month study that claimed “most people lost 5-10 pounds over 6 months.” When they say “most people,” it’s important to understand that they started with only 19 total participants and by 6 months 10 had dropped out. Those who completed the study lost 4-6 pounds more than people who took a placebo.

Further studies have found that those who restricted calories, regular exercises, and took Alli lost an average of just 5.7 pounds more in one year than did people who only dieted and exercised.

Side effects include back pain, sinus infection, soft stool, abdominal pain, fecal urgency, gas with a small amount of oil or stool, uncontrolled anal seepage, fatty or oily stool, spontaneous bowel movements, kidney stones, severe stomach pain, liver disease, pancreatitis, and kidney stones.

One thing to note here is that the only outcome they are looking at is weight loss. Research shows that if people who chose to do just the regular movement part of this, they would have more actual health benefits with less risk.

The claim of losing “5% to 10% over time” seems a bit dubious to me. It seems that it might be based on the total weight lost (rather than just the amount of weight lost over what those who didn’t take Alli lost) and may be based on the assumption that people can continue to lose weight year after year which isn’t supported by the research. I assume that they invoked the 5-10% number to try to tap into the idea (myth, really) that 5-10% weight loss results in health benefits.

To sum up, at a cost of $573.93 (the cheapest price I could find on GoodRx) the average participant would have risked all these side effects to lose 5.7 pounds more in a year than people who didn’t take the placebo, at a cost of about $100 per pound.

So both of these drugs can do harm, neither is likely to produce much weight loss, neither gives us any reason to believe that (just like every other drug) people don’t just regain the weight they lost. Plus they were both approved for use based on small, short-term studies so long-term risks are unclear. The only thing we are certain they can do is make money for the pharmaceutical industry.

In part three, we’ll look at Wegovy (semaglutide) and Tirzepatide which, even in the short studies that exist, have shown serious risks.

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More research and resources:
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*Note on language: I use “fat” as a neutral descriptor as used by the fat activist community, I use “ob*se” and “overw*ight” to acknowledge that these are terms that were created to medicalize and pathologize fat bodies, with roots in racism and specifically anti-Blackness. Please read Sabrina Strings’ Fearing the Black Body – the Racial Origins of Fat Phobia and Da’Shaun Harrison’s Belly of the Beast: The Politics of Anti-Fatness as Anti-Blackness for more on this.