drug

  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. Spine drug linked to cancer risk

    It's like a nightmare, except you never get to wake up: A drug used during a common back procedure has been linked to cancer -- including one of the deadliest forms of the disease on the planet.

    That drug is Infuse, which is supposed to stimulate bone growth after a spinal fusion procedure.

    It's already been linked to everything from infection to sterility -- but now, a leading researcher finds that high doses of the drug can boost the odds of cancer by 2.5 times in the first year alone, and by 500 percent in the three years after the procedure.

    Dr. Eugene Carragee, editor-in-chief of Spine Journal, told the North American Spine Society that these cancers include breast and prostate cancer -- and believe it or not, that's the good news.

    After all, you can fight those cancers and win (although it would be outright insane to deliberately boost your risk of either).

    That bad news: The drug was also linked to pancreatic cancer -- the same cancer that killed Steve Jobs and claims nearly 95 percent of all patients within five years.

    Dr. Carragee said the risk seemed to be greater for Amplify, a high-dose version of Infuse that was rejected by the FDA earlier this year over cancer concerns.

    Hey, every now and then the agency gets one right -- but in this case, it didn't matter. If docs want Amplify, all they have to do is up the dose of Infuse -- and many of them have been doing just that.

    What makes this so much worse is that all of it could have been avoided -- because there's evidence that the researchers behind the studies that were used to get Infuse approved turned a blind eye to its side effects.

    As I told you before, these researchers claimed the drug was practically risk-free -- and many of those same researchers were also collecting millions of dollars from Medtronic, the company that makes Infuse.

    A coincidence? You decide.

    A more recent look at the data -- including the data from the trials that supposedly found that drug to be so safe -- found that up to 50 percent of patients given Infuse experience side effects such as infection, bone loss and excess bone growth.

    And for men, the drug may also come with a risk of both sterility and a horrific condition called retrograde ejaculation.

    That last one is exactly what it sounds like: You ejaculate backwards, into your bladder instead of out the penis.

    There's no alternative to Infuse -- if you need a spinal fusion, just go without. Or better yet, find a way to avoid the surgery in the first place -- because you might not even need the procedure at all.

  3. New instructions for Tylenol

    J&J says the changes it will make -- next year, mind you, not today -- will help stop the overuse that's turned the drug's main ingredient, acetaminophen, into the leading cause of liver failure in the United States. But they're not changing the drug.

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