1. Rejected diet drug returns from the grave

    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.

    Don't forget to work in a little more movement. Another new study shows how women in particular might get a boost that goes far beyond a slimmer waistline.

    Keep reading!

  2. Feds jump the gun on diet drug

    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 it.

    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.

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