A “no” from the FDA never quite means “no” — not when it comes to the agency’s drug-industry pals, anyway.
Case in point: The feds said “no” to the diet drug Contrave earlier this year over its potential for heart risk — even after an FDA panel signed off on it.
But that “NO!” has turned into a “well, maybe…” because the drug is right now headed to market with an estimated arrival date of 2014.
It hasn’t been approved — yet — but the feds have reversed their call for a long-term study to help ensure the drug is safe for consumers and instead OK’d a much less demanding bit of research that could be signed, sealed, and delivered in just two years.
In other words, the drug isn’t being improved to meet strict FDA safety standards. Instead, those already-low standards are being brought down to meet the drug.
Congratulations, guys. You managed to screw up one of the rare times you actually almost got it right.
The drug itself isn’t even all that new — it’s actually a combination of two older meds: the antidepressant Wellbutrin and the anti-addiction drug naltrexone. Since both meds have weight loss (among other things) as a “side effect,” the thinking is obviously to combine them and just call it a “weight loss drug.”
Just one problem: Neither one leads to a whole lot of weight loss, and even when combined the two won’t help most people slim down: Studies have shown that people who take Contrave lose an average of 4 percent more than those who take a placebo.
But here’s what else you could get in the bargain: nausea, headaches, constipation and a potentially dangerous boost in blood pressure that could put anyone — especially an obese person looking for a quick diet fix — at risk for a heart attack or stroke, which is why the FDA wanted that new study in the first place.
Since these types of heart problems could be years in the making, don’t expect the compromise two-year study to close the book on that risk.
If anything, it’ll be just the first chapter.
There are much better and far safer ways to lose weight, starting with a diet devoid of sugar and the rest of the refined carbohydrates. Instead of a higher blood pressure, you could actually lower yours — it’s one of the first “side effects” of going low carb.
Edward Martin is a health journalist who writes about today's most pressing health issues. He chronicles the most cutting-edge alternative methods for beating everything from diabetes to cancer and reports on the latest FDA foul-ups and Big Pharma conspiracies.