It's the world's biggest drug experiment--and you're invited to be a part of it.
An FDA panel has voted to approve a new diet drug despite potentially deadly risks, but don't worry. They have a plan for that: They also voted to keep studying the drug once it's on the market.
Approve first, ask questions later--but the FDA is expected to sign off on the plan just the same.
The new drug is called Contrave, but it's actually not all that new. It's a combination of two older drugs: the antidepressant drug Wellbutrin, and the anti-addiction drug naltrexone.
Both meds are known to cause weight loss, which is how they find themselves in this medication marriage--but that's not the only side effect they share. Both drugs can also cause high blood pressure, putting patients at risk for heart attack and stroke.
How much of a risk? No one knows, because it hasn't really been studied... but that little fact didn't stand in the way of the panel, which voted 13-7 to approve it.
The same panel voted 11-8 to keep studying it, by the way.
I don't know what's worse--that 13 panelists signed off on this med despite the risk, or that eight of them don't even think those risks need to be studied.
And high blood pressure isn't the only potential risk.
Patients who took the med in the clinical trials experienced more seizures than those on the placebo--despite the fact that researchers excluded anyone with a history of the condition.
The drug can also cause nausea, headaches, constipation and a faster pulse--making it pretty easy to see why 40 percent of the patients in clinical trials dropped out.
And even those who stuck with it to the end didn't necessarily get much of a reward: In one study, Contrave patients lost an average of a little more than 4 percent of their body weight.
That's even below the FDA's own threshold for "effectiveness," which is set at a laughably low 5 percent.
Some patients did lose more, but even that's hard to celebrate--because researchers believe the weight will stay off only as long as the patient takes the med.
In other words, like so many other drugs on the market today, it's not a short-term cure... it's a lifelong commitment.
Usually, I say there are no shortcuts when it comes to weight loss... but in this case, losing weight through lifestyle changes such as a healthy low-carb diet really is a shortcut-- because it won't take a year to see real results.
Sometimes, the right way is actually the easier way--if you're ready to commit to it.