drug company

  1. Who's paying your doctor?

    Everyone likes free stuff, and your doctor is no exception.

    But when those gifts come from a big drug company, they come with strings attached: prescribe our drugs... prescribe them more often... and prescribe them for more people.

    Soon, it's going to be easier than ever to figure out if your doc is on the wrong end of one of these arrangements -- because every drug company with even a single product covered by Medicare will have to report every last penny they give to doctors.

    Doesn't matter if it's a $50,000 speaking fee for being a "thought leader" or a $50 lunch for his office staff -- it has to be reported to the feds, who will then place it online for the world to see.

    This has been a long time coming, but your doctor probably can't figure out why. He thinks he can't be influenced -- that he might get a gift or cash from Big Pharma, but he can still think for himself.

    The track record says otherwise: Docs who get cash and prizes from drug companies are more likely to use that company's drugs and are even more likely to use them off-label for unapproved conditions.

    One Big Pharma rep told NPR in 2010 that he could pay a doctor $1,500 to deliver a short presentation prepared by the company -- and the following week that doctor will write up to $200,000 in new prescriptions for his company's drugs.

    That's one heck of a return on investment.

    So, starting later this month, you'll be able to search a federal database and see who's giving your doc what -- from those mutually lucrative speaking fees to a cheap lunch.

    Companies that fail to report payments and other gifts will be on the hook for fines of $10,000 per violation -- but with a cap of $1 million a year, that alone is probably not enough to get the industry's attention.

    After all, drug companies routinely pay hundreds of millions and even billions of dollars in fines. Next to that, a million bucks is a bargain -- the kind of spare change they might find in the CEO's sofa cushions.

    But the new law has some other penalties that could turn out to be a lot harsher than any dollar amount: A senior official -- the CEO, CFO or the chief compliance officer -- is going to be held responsible for the accuracy of each report.

    And if it's got a few missing pieces, he could face some consequences.

    Fines might not get their attention -- but that sure will.

  2. Drug company launches new attack on compounding pharmacists

    It was the equivalent of David taking down Goliath: Earlier this year, compounding pharmacists stood up to a drug company -- and won big.

    But in this version of the tale, Goliath doesn't lie down and die. He gets back up -- and now, he's really ticked off.

    Before I get into that, let me recap the story so far: For years, compounding pharmacists made a generic version of 17-hydroxyprogesterone, a hormonal treatment given to pregnant women to lower the risk of a preterm birth.

    Despite its wide availability, it was considered an "orphan drug" by the FDA -- allowing KV Pharmaceuticals to swoop in, slap a patent on it, and re-name it Makena earlier this year.

    Then, the company raised the price to $1,500 a shot and threatened legal action against any compounding pharmacist who continued to make the cheap generic version.

    Naturally, women were outraged -- and they remained outraged even when the company cut the price to "only" $690 a shot. And that's when the FDA stepped in and told compounding pharmacists not to worry -- they could keep making their own version of the drug.

    Believe me, I'm still rubbing my eyes over that one.

    But maybe it really was a dream after all, because the company is still trying to get the generic hormone pulled from the market.

    And this time, they might succeed.

    KV quietly ordered samples of 17-hydroxyprogesterone from a handful of compounding pharmacists, then hired a lab to perform tests on behalf of the company.

    No conflict there, right?

    Naturally, the tests "found" that the compounded product was indeed different from Makena, which isn't the point.

    Of course they're different -- they're custom-made, but that doesn't mean the product is bad. There's no evidence that these variations make the treatment any less effective, and no evidence they pose any more of a risk than Makena.

    In fact, the same people who produced these "bad" samples are the same compounding pharmacists who've been reliably making the treatment for years -- giving them a much better real-world track record then Makena.

    But the company sent its test results to the FDA, and the agency is now "investigating." The feds even sent out a reminder saying that approved drugs like Makena come with a "greater assurance of safety and effectiveness" than those from compounding pharmacists.

    Stay tuned... but I think that last bit is a sign that the writing's on the wall: Goliath is back on his feet.

  3. ADHD meds reach new highs

    Attention-deficit hyperactivity disorder isn't a diagnosis designed to help identify and treat children -- it's a condition tailor-made to sell meds.

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