FDA moves to approve risky diet pill

Dangerous drug gets second chance

Still struggling to meet that New Year’s Resolution of losing weight? The FDA may soon have a solution for you–if you don’t mind just a couple of little problems.

In 2010, the FDA rejected a weight-loss drug called Qnexa for some very good reasons. Namely, the concerns that it could cause birth defects and heart problems.

But now, for some reason, it’s back. An FDA committee recently voted an unbelievable 20-to-2 to recommend approval of the drug.

So did it magically lose its links to birth defects and heart problems?

Nope!

The drug is being reconsidered by the FDA just because obesity specialists and “patient advocates” (or should that be “Big Pharma advocates”?) say there aren’t enough weight-loss drugs out there. Oh, yeah, that makes perfect sense!

And by “perfect sense,” I mean “no sense at all.”

I mentioned Qnexa in an e-Tip early last year, when I questioned why it was even in front of the FDA in the first place. Qnexa contains topiramate, which at the time was under fire for–you guessed it–its connection to birth defects. (The latest data shows that using topiramate during pregnancy raises the risk of oral clefts by a factor of two to five.)

Here we are again, looking at a potentially dangerous drug that could very well end up on the market only because there aren’t enough drugs available. Rather than hold off for something safe and effective, I guess the FDA would rather just pick the best of the worst and be done with it.

Which is a dangerous stance to take, considering that millions of people could end up taking this drug if it’s approved.

Qnexa actually has two blows against it that, in my mind, should have kept it from ever reaching the light of day. First, there’s the topiramate. Then, there’s the second drug in the combo–phentermine (yep, one part of Phen-Fen–which was pulled only six months after its approval because it increased the risk of serious heart disease).

The advisory committee wants a new clinical trial from Vivus, the maker of Qnexa, to assess the drug’s effect on heart side effects (it may cause elevated heartbeat). But here’s the thing–they don’t mind having the trial conducted AFTER the drug is approved. Sure, why not? I’m sure those millions of potential users of Qnexa would be happy serving as guinea pigs while Vivus rakes in the dough. For now, the committee says the FDA can just throw a few warnings on the drug. I feel better already.

So we already have a couple of reasons for why this drug shouldn’t be back in front of the FDA, no matter how much they say we need more weight-loss drugs on the market.

Then we get to the kicker–it might not even work all that well. In the second year of one of the trials, patients regained up to 20 percent of the weight they’d lost in the first year. And that was just in the second year. We’re talking about an appetite suppressant, not a lifestyle change. Do you have to use Qnexa for the rest of your life to see any results? I bet that prospect makes Vivus pretty happy.

Oh, and one last thing–about that claim that there’s not enough out there to help people lose weight. First of all, a quick perusal of the archives at www.nutritionandhealing.com offers pages and pages of solutions–but since none of them are patentable, of course they’re not even on the mainstream’s radar.

Second, here’s the subject of an article I read the very same day I read about the FDA’s reconsideration of Qnexa: Daily supplementation with vitamin D3 may cut fat mass and actually boost your heart health. A new study in the British Journal of Nutrition reveals that 1,000 IU of vitamin D3 daily was linked to significant reductions in body fat mass.

So the “experts” say there aren’t enough weight-loss drugs on the shelves. But while they’re busy counting Big Pharma concoctions, Mother Nature is offering up plenty to help us win the battle of the bulge without putting our health at risk.

Sources:
“FDA Panel Votes in Favor of Qnexa,” Medpage Today (medpagetoday.com)

“Side Effects of Diet Pill Still Concern Regulators,” The New York Times (nytimes.com)

“Vitamin D may cut fat mass, boost heart health markers,” Nutra Ingredients USA (nutraingredients-usa.com)