sterility

  1. 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.

  2. When 'risk free' means 'big risk'

    Imagine going in for a "risk-free" spinal surgery for back pain... and waking up to find you're sterile as a result.

    If that's not bad enough, that same "risk-free" procedure -- backed by at least 13 major studies -- could also leave you battling a dangerous infection and even cause the loss of the very bone you're trying to protect.

    Looks like "risk free" just ain't what it used to be.

    In an explosive scandal that had one medical journal devote an entire issue to it, 15 researchers who pushed the bone protein Infuse for spinal fusion surgeries collected at least $62 million from Medtronic, the company that makes it.

    Of course, these are the same researchers who reported zero adverse events or complications in those 13 studies -- but a
    new look at the same data tells a very different story.

    The Spine Journal says it found adverse events in between 10 and 50 percent of Infuse patients -- and along with the sterility, infection and bone risk I mentioned earlier, some patients faced the horrific-sounding side effect of "unwanted bone growth" and even a possible increase in cancer risk.

    That's a lot of risk to miss -- but maybe those Infuse researchers were too busy counting all the money to notice.

    And while the researchers counted their millions... Medtronic has been counting its billions.

    Infuse has quickly become a major player in the spinal surgery game, used in up to a quarter of the estimated 432,000 spinal fusion surgeries performed each year in the United States, according to the New York Times.

    That's good enough for $900 million in sales last year alone -- or, in accounting-speak, well worth the $62 million research "investment."

    Medtronic, naturally, thinks it's off the hook because all the risks are actually listed in the product warning even if they're not mentioned in the studies -- but that's as insincere as it is dishonest.

    They know the medical journals are gospel to many doctors, and even a single study that declares a new procedure to be risk-free is going to influence treatment decisions.

    In this case, Infuse had more than a dozen studies that claimed no adverse events -- and that meant far more to doctors than any warnings buried in the fine print.

    The bigger issue here is that spinal fusions and other back surgeries for pain are performed far more often than necessary... and in many cases, they don't even work.

    There are safe and non-surgical options available for back patients -- and they start with a simple massage.

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