Medtronic

  1. Big conflicts in studies behind bone growth drug

    When objective science isn't objective at all

    You know what they say about something that sounds too good to be true, right?

    Infuse sure sounded too good to be true when it first hit the market, but that didn't stop doctors from believing the hype about the bone growth drug.

    And can you blame them? Infuse was practically the answer to their prayers: A drug that could help regrow bone after spinal fusion surgeries with virtually no risk of side effects.

    That's how the studies made it sound, anyway -- and not just one or two of them. Eleven studies backed this bone growth drug in a big way.

    One study was so unanimously glowing and overwhelmingly positive that at least one reviewer thought it sounded like marketing material from the bone growth drug's maker, Medtronic, rather than objective scientific research.

    If only they knew how right they were.

    Turns out, Medtronic's marketing team had direct input on the studies. They helped draft, write, and edit studies, according to an investigation now under way in the U.S. Senate.

    Ironically, they allegedly even helped draft a response to the reviewers who thought the studies sounded too much like marketing material.

    The company also funded the research itself, of course. That's not unusual -- it happens all the time, and is usually (but not always) disclosed in the conflicts section of the study.

    But in this case, the cash relationship may have gone beyond writing a check to cover the cost of the research. Way beyond it -- because according to the Senate investigation, Medtronic paid the 13 main doctors who "led" the research a total of $210 million over 15 years in consulting fees and other work supposedly unrelated to their Infuse research.

    Maybe the work itself was unrelated, assuming it was actual work. But it certainly has the feel of a "you scratch my back, I'll scratch yours" arrangement -- especially since the glowing Infuse studies helped the drug become an $800-million-a-year product.

    When you're taking in $800 million a year, $210 million over 15 years is practically pocket change.

    Now, this is already beyond ugly. But, if found to be true, it's also dangerous -- and potentially deadly. Like I mentioned earlier, the studies found virtually no side effects, which is why so many doctors used it on their patients, turning the drug into such a big moneymaker.

    But they found out the hard way that the bone growth drug comes with some very real side effects -- and that anywhere from 10 percent to 50 percent of the patients who are given Infuse can experience them.

    Since the drug stimulates bone growth, it can work too well in some patients -- causing too much bone to grow, and one doctor reports sometimes leads to painful conditions that require surgery, sometimes multiple surgeries, to correct.

    Infuse has also been linked to male sterility and a condition called retrograde ejaculation. That's when men ejaculate backwards, into the bladder instead of out the penis.

    There's also a risk of infection and bone loss, and it has been linked to increased cancer risk, including cancers of the breast, prostate, and pancreas.

    So whatever you do, as the old saying goes, don't believe everything you read -- even when it's published in a major medical journal. And to paraphrase that other old saying, if something sounds too good to be true... it may have been paid for by a drug company.

  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. 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.

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