New Drug Provides Very “Modest Weight Loss”

Have you heard of the new weight loss drug, Belviq?

Then gather ‘round, boys and girls, cause we have a rare opportunity to watch sausage being made.

This is the best time to talk about Belviq, because no one’s really heard of it—yet—so we have a chance to talk about what it does and doesn’t do before we’ve been subjected to what will probably be one of the most expensive pharmaceutical marketing campaigns in years. At that point everyone will have heard of Belviq, anyone who is even a few pounds overweight will be asking their doctor about it—(“Ask your doctor if Belviq might be right for you”)—and I will undoubtedly get a gazillion questions about it on the website.

So, as Ed Schultz would sway, “Let’s get to work”.

On June 27, the Food and Drug administration approved a new weight loss drug, lorcaserin, which is made by Arena Pharmaceuticals and marketed under the brand name Belviq. It’s the first time in more than ten years that a weight loss drug has been approved by the agency, so expect everyone to make a really big deal out of that.

Up to now, everything about Belviq has been “behind the scenes”. It was reviewed by the FDA in 2010 and rejected, one because it produced “modest weight loss” and two because there were concerns about a rat study linking the drug to mammary tumors. But Arena came back to the FDA with new data.

The new data—in research sponsored by the manufacturer—showing that 38% of patients had lost 5% or more of their starting weight in a year. Among people taking a placebo, only 16% of patients lost that amount of weight.

OK everyone, let’s do some math.

If you’re 200 pounds and you lose 5% of your weight over the course of a year—commendable, by the way, I’m all for it—you’ve lost all of 10 pounds. In a year. Which, if I remember my elementary school long division, would come to 10 divided by 12 months or a grand total of .83 pounds per month.

That’s decimal point 83, in case you missed it.

Meaning less than one pound per month.

Meaning approximately 4/5 of one pound. Per month.

Am I making myself clear?

Not only that, but 16% of patients were able to lose that much just taking a placebo, meaning that of the 38% of patients on the drug who had these nothing-to-write-home-about results, 16% would have lost the weight on a sugar pill anyway. That means that the actual percentage of patients in the study who achieved these results because of the drug was only 22%.

FDA Committee member and Professor of Medicine at the University of Colorado Daniel Bessesen, who voted for approval, said the drug provides “a modest weight loss, and it’s not what we would like.”

No kidding.

Then there are the safety issues. The data shown to the FDA fell just short of the standard the agency sets to rule out an excess risk of valvular heart disease. An increased risk for heart-valve disease was what ultimately caused Fen-Phen to be withdrawn from the market.

The sausage making part of this story is this: Watch carefully over the next couple of years at how the data on this drug is spun in the sure-to-be spectacular marketing campaign that will be waged on its behalf. These guys are so good at what they do that they will make you forget that their own studies showed only 8/10 of a pound a month weight loss (for a 200 pound patient), and that most people didn’t even achieve that.

And when you’re tempted to give it a try, please remember to come back to this article and read it again.

Four-fifths of one pound a month.

In about 22% of patients. (In other words, 78% didn’t even achieve that!)

With potential safety issues and side effects that generally don’t become well known till a drug has been out in the market for a while (i.e. Vioxx, Fen-Phen.. shall I continue?)

But by the time Big Pharma’s marketing departments get done trumpeting “significant results” and “38% of all patients lost an impressive 5% of body weight” and showing you commercials with happy, slim people running around the beach, you’ll almost be convinced.

Don’t feel bad. I almost bought a thighmaster once.