risks

  1. Missed opportunity

    FDA panel fails to raise alarm on bone meds

    Osteoporosis meds have been linked to kidney failure, crippling pain, death, and even -- ironically -- shattered bones.

    So what's an FDA "expert panel" doing to protect the 5 million women who take bisphosphonate meds such as Fosamax, Actonel, Reclast, and Boniva every year?

    Nothing!

    Sure, they issued a lukewarm call for the agency to include new information about the risks and supposed benefits of long-term use. But don't bother asking the expert panel what that information should include -- they have no idea.

    What, do you think they are, experts or something???

    The FDA's own scientists even told the panel they found no advantage to taking the meds for more than five years -- but the panel clearly missed that part of the discussion.

    "I don't think we have enough data to restrict anything at this point," panelist Dr. Maria Suarez-Almazor told Reuters, despite plenty of data linking these meds to an increased risk of bone breaks, especially when used longer than the five years those FDA scientists mentioned.

    "I'm used to dealing with ambiguity in a clinical setting, but this raises it to different heights," complained another panelist, Prof. Brian Erstad.

    But there's no ambiguity here. Along with the risk of breaking the bone they're supposed to protect, bisphosphonate meds have been linked to kidney failure, esophageal cancer, serious gastrointestinal problems, and even the death of the jawbone.

    The panel's pussyfooting means the FDA itself will have to decide what warning, if any, the drugs should carry. But don't wait for them to act -- because these meds are risky whether you take them for five years, five months, or five minutes.

    There are better and more natural ways to protect your bones as you age, including a simple mineral that most people are missing out on.

    And no, it's not calcium.

    I have everything you need to know about bone health in the November 2009 issue of my Douglass Report newsletter. If you're a subscriber, login now and read it in my archives.

    And if you're not, sign up today.

  2. Spinal scandal

    Surgeons hide bone treatment risks

    Medical research is a pay-for-play business. If you're willing to pay, researchers will play.

    Here's the latest: A handful of surgeons came out with a series of glowing "studies" claiming that a new bone treatment procedure had virtually no risks.

    No risks, huh?

    Nothing sets off my BS meter like those two little words -- especially when you're talking about something as complex as a bioengineered protein used to spur bone growth during spinal fusion surgeries.

    Sure enough, a new look at the data found that anywhere between 10 percent and 50 percent of patients suffered conditions such as male sterility, infection, increased pain, bone loss and -- picture the horror of this one -- unwanted bone growth.

    Are we talking an extra arm here... or just a sixth finger?

    Of course, there's a reason researchers were so willing to overlook these risks -- 62 million reasons, to be precise. Fifteen of the key surgeons behind 13 Infuse studies collected a combined $62 million in payments from Medtronic for other work, according to The Spine Journal, which devoted an entire issue to the scandal.

    And to this day, some of those researchers remain positively delusional.

    Dr. Thomas A. Zdeblick, who co-authored three of the studies, told the New York Times he had no "direct financial interest in the success of Infuse or Medtronic."

    Is this guy for real?

    The Times says Zdeblick collected more than $20 million in royalties from the company for his patents on several devices, including one used with Infuse.

    "No direct financial interest" my rear end!

    But there's a bigger problem here -- way bigger than Zdeblick or Infuse -- and that's the peer review process, which is now exposed for the joke that it is.

    Every one of those 13 studies made it through -- which shows that peers aren't doing a whole lot of reviewing.

    Think about THAT the next time you read a breathless report on the next big drug or medical device.

  3. Sun exposure finally declared healthy

    A new study was recently released suggesting that the health benefits of the sun actually OUTWEIGH its risks-specifically the risk of skin cancer.

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