A skunk by any other name
Remember Ayds, the appetite-suppressant “candy?”
When I was a kid, I came across my mom’s Ayds stash. (Don’t tell her I told you!) I thought it was candy, of course. I snuck pieces for weeks before Mom found out. She actually thought it was funny. She had quit eating them because she didn’t lose any weight.
I asked her if I could finish the box and she stopped laughing. “No!” (Okay. Just checking.)
A few years later, Ayds sales dropped off when the AIDS crisis began. So they changed the name to Diet Ayds. That’s right. They left the word “Ayds” in the name. Hmmm. I wonder why that didn’t work? Ayds folded in the 80s.
Today, a new diet aid is trying the same maneuver. The circumstances are different, but it’s the same idea. Distract consumers with a new name to avoid a negative association.
Only this time, the association is with the drug itself, the change is bigger, and the dangers are potentially just as deadly as any dreaded disease.
Second time’s the charm
The newly approved diet drug is Qsymia. But it used to be Qnexa. And it seems pretty clear that the name change is an attempt to rehabilitate a dirty image (or to create new Q words for Words with Friends).
Two years ago, Qnexa was bad news. Back then, an FDA panel voted against approval. They gave three reasons: Increased risk of heart attack, stroke, and birth defects.
But now, the drug is Qsymia. And it’s FDA approved! Not only that, but WebMD notes that a second FDA panel “overwhelmingly voted” for recommendation. Impressive! So everything is good, right?
Instead of changing the drug to make it safer, somebody changed…the panel. WebMD doesn’t mention that the second panel included five experts from the first panel who voted, “Yes.” Missing from the second panel where four of the experts who voted “No.”
See how easy it is! Get out that big FDA rubber stamp and let’s get this drug on the market!
But even the second panel couldn’t ignore the glaring safety concerns. They’ve directed Vivus, Inc., the maker of Qsymia, to launch post-marketing studies to determine risk of heart disease and stroke.
Yep – FDA business as usual. Sad and familiar. Sell the drug! We’ll get back to you later about those potentially fatal side effects.
And the risk of birth defects must be substantial because the warnings are pretty dire.
For instance, the agency advises women who might become pregnant to use birth control while taking Qsymia. They also recommend monthly pregnancy tests. And in the hopes of enforcing these recommendations, Qsymia will only be available from specially certified pharmacies.
But this isn’t overkill. Not at all. In a pre-approval study, participation required “rigorous contraceptive methods.” Even so, more than 30 subjects became pregnant!
Now, if Qsymia transformed obese people into svelte non-diabetics, popping these pills might be worth the risk to some. But in those pre-approval studies, obese subjects who took Qsymia reduced their weight by about 10%. And that modest success rate only occurred in subjects who successfully reduced calorie intake and exercised.
Think of all the people who will take Qsymia, but won’t do the work. The drug will expose them to all the potential dangers with little or no benefits.
Qnexa. Qsymia. Call it whatever you want. Just don’t take it.
“FDA Approves Diet Drug Qsymia” Salynn Boyles, WebMD Health News, 7/17/12, webmd.com
“Surprise!! FDA Panel Endorses The Vivus Diet Pill” Ed Silverman, Pharmalot, 2/22/12, pharmalot.com