Bextra

  1. Pfizer pays the price – but it's not high enough

    What's the most dishonest company in America? Tough call – but I've got 2.3 billion reasons to put Pfizer at the top of the list.

    Pfizer, biggest of all the Big Pharma kingpins, was hit with a record $2.3 billion fine – the heftiest fine ever levied on a drug company, and the largest settlement ever in any U.S. criminal case.

    "Criminal" is one of the nicer words I'd use for them.

    The feds say these crooks paid off doctors with free golf, junkets at fancy resorts and massage sessions to promote their meds, including an effort to get them to prescribe a dangerous drug for an off-label use at an unapproved extra-high dose.

    While the case revolved around a number of meds, most of the fines centered around the painkiller Bextra, a drug so disastrous it was ultimately pulled from the market.

    Bextra was approved for menstrual cramps and arthritis. Studies had shown that when it came to other kinds of agony, like acute pain and surgical pain, Bextra was no better than ibuprofen – but with far worse side effects.

    None of that mattered to Pfizer. The company's sales team told docs that this dangerous med could be used at high doses for all kinds of pain. Never mind that the risks to the heart, skin and kidney grew worse as the dose increased.

    Doctors were so busy pulling treats from the Big Pharma cookie jar that they went along with this dangerous scheme.

    The U.S. Justice Department says that even as the company negotiated the settlement, they continued to engage in the very same chicanery that led to the fines in the first place.

    And here's what's truly amazing: It's the company's fourth big settlement since 2002. It's not that Pfizer doesn't get the message – they just don't give a hoot. Fines and penalties are just another line on the budget.

    To them, $2.3 billion is nothing when a med like Viagra can take in $5 billion a year alone. In fact, Pfizer sells $2.3 billion in drugs every three weeks. That's like docking a wealthy corporate crook just three weeks pay for raiding trust funds.

    It sounds like a lot to us – but it was worth it to him.

  2. The FDA's hit parade of big "oops" stories

    The FDA's hit parade of big "oops" stories

    The FDA has all the usual flaws that go hand-in-hand with any government bureaucracy. The difference is that when the FDA fouls up, people die. The organization has been getting a lot of flak lately, from more than just me.

    It's about time people started to notice.

    Most of the FDA's critics recognize, as I often point out to you, that the Administration's failures are rooted in its close ties and associations (often financial) with the medical industry. A perfect example of this conflict of interest is the 1992 Prescription Drug User Fees Act, which requires the FDA to approve or deny new drug applications by major pharmaceuticals within a certain time - or else they have to refund "application fee" monies paid by the pharmaceutical companies. Obviously, the rush job isn't doing anyone any good.

    The FDA has approved too many drugs that ultimately had to be pulled from distribution due to serious side effects - i.e., THEY WERE KILLING PEOPLE. Even the government's own General Accounting Office determined that the process set in motion by this act has coincided with an up-tick in the percentage of drugs that ultimately needed to be withdrawn from the market. Coincidence? Hardly.

    After ranting and railing so often against the FDA, I just wanted to remind you all of some of the Administrations' biggest gaffes. While major drugs being pulled from the market are worthy of lead stories on the 11 o'clock news, too often the stories about "minor" drugs that get pulled are tucked away in places where they're easy to miss unless you're me, who lives for this sort of stuff.

    Here's the FDA's "hit parade" of big "oops" stories.

    1. Vioxx - I'm sure you're familiar with this infamous anti-inflammatory. Merck had to pull Vioxx off the global market in 2004 after a clinical study demonstrated that it significantly increased the risk of cardiovascular "events" such as heart attacks and strokes.
    2. Bextra - Like Vioxx, this prescription painkiller caused an increased risk of heart attack and stroke. Pfizer pulled it off the market in the U.S. a year after the Vioxx fiasco in 2005.
    3. Cylert - Abbott pulled the Attention Deficit Hyperactivity Disorder (ADHD) drug off the U.S.
      market in 2005 after the FDA discovered 13 cases of liver failure. Turns out that Cylert patients have a 25-percent higher rate of liver failure compared to the general population.
    4. Baycol - This cholesterol-lowering drug caused users to suffer from a much higher rate of rhabdomyolysis - a debilitating muscle ailment that can be fatal. There were 31 reported deaths that were directly linked to Baycol, and it was yanked off the market in the U.S. in 2001.
    5. Palladone - This slow-release narcotic painkiller by Purdue Pharma was pulled off the market in the U.S. in 2005 because it was found to cause side effects like depression and even coma when mixed with alcohol.

    This small handful of examples of FDA foul-ups within recent years (there are more - this list could've been much longer) should serve as a wake-up call for every single one of us. In spite of the FDA, neither food nor drugs are any safer.

    FDA leaves cancer-causing foot gel on the market

    Even the most seemingly innocent drugs can carry fatal side effects. The FDA just announced a study showing that the foot gel Regranex could be causing cancer. And yet, amazingly, Regranex is still on the market!

    The prescription foot gel is manufactured by Johnson & Johnson and is often used by diabetics who develop leg and foot ulcers that are difficult to heal.

    Apparently, diabetics who'd been prescribed the gel three or more times were at increased risk of death from cancer. With incredible gall, the spokesperson for J&J insisted that Regranex is safe when used as directed. What? This is a topical foot gel-if these people are applying it to the sores on their feet and legs, they ARE using it as directed. Should any foot gel be capable of giving you CANCER!? Does this make sense to you?

    Obviously there's more to this story. But if I were you, I wouldn't wait for the FDA to do the banning - ban Regranex from your medicine cabinet immediately.

  3. Prescription Painkiller Scandal

    I know I've talked a lot about the Cox-2 inhibitors (Vioxx and company) prescription painkiller scandal in the last 10 months, but what can I say?
  4. Are the drugs you're taking safe?

    Over 80% of American consumers are at least somewhat confident that the drugs they're taking are safe - and that the FDA is doing its job in fine fashion.

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