patent protection

  1. The darkest shade of green

    Imagine a drug that failed to meet basic targets set by the FDA, came with a higher risk of side effects than its predecessors, and was found to be so unimpressive and even dangerous that the agency's own experts advised against approving it.

    Now, stop imagining -- and just take a look at Aricept 23, because an explosive new analysis in BMJ says that's exactly how this drug reached the market.

    How did it happen? Let me back up to 2010, when the original Aricept -- a drug that did up to $2 billion a year in sales -- was about to lose its patent protection.

    Once cheap generics flood the market, it's usually the end of the line for the money train -- unless you have a few tricks up your sleeve, like what the industry calls "evergreening."

    That's a slight tweak to help extend the drug's profitable life. It might be a timed-release formula, the addition of a second drug to the mix, or even a change to the dosage itself -- and when the FDA signs off on it, the "new" drug gets three more years of protection.

    In this case, it was a change to the dose. While "old" Aricept had been approved in 5 mg and 10 mg doses, Aricept 23 is -- as the name implies -- 23 milligrams of the drug.

    The feds said this high dose would be approved only if it beat the lower doses in two key areas: overall cognition and global functioning.

    That shouldn't have been too hard, since the old formula was thoroughly unimpressive itself. But Aricept 23 offered only tiny improvements in cognition and no changes at all in the more important measure of global function -- and came with a higher risk of nausea and vomiting as well.

    Those side effects are bad enough for a healthy person. But for an Alzheimer's patient, they could be dangerous and even deadly.

    No matter. An agency bigwig went against the advice of his own experts and approved the drug anyway -- just four months before the expiration of the original Aricept patent.

    Since the generics would only be available in the old 5 mg and 10 mg doses, even a combination of pills wouldn't add up to the "new and improved" dose. The only way to get it was to keep buying the expensive brand-name version.

    In other words, the new formula of Aricept didn't protect dementia patients from the ravages of the disease -- but it did protect the profits of the drug's makers, with three years of fresh patent protection.

  2. Feds finally own up to statin risks

    Not long ago, those of us who pointed out that cholesterol meds can actually cause diabetes and other serious health problems were dismissed as alarmists.

    Statins, we were told, are so safe they should be given to practically everyone – with some "experts" even pushing to give them out with every Big Mac. (That might sound like something I made up for an easy laugh – but believe it or not, it's actually true.)

    Well, maybe now the push to give everyone statins will start to slow a bit: The FDA has finally admitted that all those side effects the drug industry and its paid--for experts once brushed off are actually very real.

    And now, they want the labels of these meds changed to reflect the increased risk of diabetes, confusion, memory loss, and serious muscle pain.

    The feds say those side effects can hit anyone at anytime. They can strike after a single day on these meds...or they can come on after years of taking them without incident.

    And they can happen to everyone across all age groups.

    So who's the alarmist now?

    Of course, I can't help but find it a little suspicious that this warning comes only after every Big Pharma statin except for one – Crestor – lost its patent protection, with Lipitor going generic just a few months ago.

    It's almost as if the feds were giving their drug company friends a chance to maximize profits before issuing the same warning those of us in natural health delivered years ago.

    But even worse than the risks and the delayed warning is the fact that no one ever needed these meds in the first place.

    In many cases, people taking statins don't even have a cholesterol problem since mainstream LDL targets are set unrealistically low. And even when cholesterol does shoot up to high levels, taking a drug to "cure" it is akin to Homer Simpson putting a piece of tape over the "check engine" light on his car.

    Super high cholesterol is a warning that something's wrong – and lowering it without fixing the underlying issue won't make you healthier any more than that piece of tape will fix Homer's engine.

    If your own levels start climbing too high for comfort, work on lifestyle changes first. Cutting out sugars and sticking to fresh foods will almost always bring cholesterol to where it needs to be.

    If they're still high, don't visit a statin-slinging mainstream doc. Visit a naturopathic physician who can find and fix the real cause without meds.

    And for one easy way to lower your cholesterol naturally, keep reading.

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