Pfizer in hot water over Lipitor marketing

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MD and I are safely ensconced in Dallas after a flawless U.S. Air flight that even involved a connection that went smoothly. I’m still immersed in comment hell, but I’m working through them (about halfway, so far). I’m going to give it my best effort to get completely caught up by Christmas.

While zipping through the winter skies I got caught up with a lot of my reading that had stacked up while I was in New York. Buried deep within one of the sections of last week’s Wall Street Journal was an article about a lawsuit against Pfizer, the maker of Lipitor. It seems that one of their own is turning on them.

According to the lawsuit, a former employee, Dr. Jesse Polansky, who was the former director of outcomes management strategies from 2001 to 2003 got the boot because he complained to his superiors about marketing practices he considered improper. What marketing practices? Well, for starters, the Pfizer physician education campaign that

led thousands of physicians to prescribe Lipitor for millions of patients who did not need medication.

Dr. Polansky’s allegations also included complaints that Pfizer was underwriting continuing medical education programs for doctors that encouraged ‘off-label’ uses of Lipitor.

Pharmaceutical companies are prohibited from marketing drugs for indications other than what the FDA approves them for, although doctors aren’t prohibited from prescribing them for unapproved uses. Independent educational programs can discuss off-label uses that aren’t FDA approved. But Dr. Polansky’s lawsuit charges that the Pfizer-funded programs weren’t independent.

The Lipitor educational programs were run by companies paid by Pfizer through “unrestricted educational grants,” the lawsuit says. It alleges that the educational programs were integrated into the marketing plan for the drug, citing an internal Pfizer marketing plan for Lipitor with a page titled “Medical Education Platform Supports the New Positioning.”

This ‘off-label’ business is huge for pharmaceutical companies. The deal is that pharmaceutical companies can market drugs to physicians for only those conditions that have received FDA approval. Physicians often discover other uses for drugs that aren’t FDA approved, but the drug companies can’t advertise them without going through the horrendously expensive FDA approval process. Physicians will tell other physicians about the ‘off-label’ uses for a specific drug, and such uses are often presented at medical meetings. The rub comes when the pharmaceutical companies manufacturing one of these drugs underwrites all or a portion of the medical meeting in which the ‘off-label’ use is presented. In Pfizer’s case, Lipitor is approved for patients with a certain risk level for heart disease, but not for those in the moderate-risk category.

Among other things, Dr. Polansky says Pfizer wanted to extend Lipitor use beyond the indications found on the drug’s label by targeting people at moderate risk of developing heart disease or having a heart attack. He said the educational programs for doctors deliberately misrepresented the drug’s label to encourage Lipitor therapy for people in the moderate-risk category who didn’t need the drug.

Which means that it’s pretty obvious that the folks in control at Pfizer know that those patients in the moderate-risk category don’t need Lipitor (actually, most patients don’t need Lipitor period), yet they continue to encourage doctors to prescribe to them. A sorry state of affairs since all the statin drugs, including Lipitor, are not without side effects, some of which are fatal. It’s all a matter of risk versus reward. To prescribe a medication that has the potential to kill a patient when the medicine won’t really do the patient any good is not good risk management and certainly not good medicine. You would think what with Lipitor being the world’s biggest selling drug with sales of $13.6 billion last year that Pfizer would be satisfied, but apparently not. I hope they get hammered.

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12 thoughts on “Pfizer in hot water over Lipitor marketing

  1. I find their adversizements with Dr. Robert Jarvik particularly offensive. How many more artificial or transplanted hearts will be needed to cure the side effects of Lipitor?

  2. I find all the ads for statins (Zetia, Vytorin, Zocor and Lipitor) to be offensive! You’d think it’s some of miracle-drug with air-time they get!

    Everyone in my family is on them: Daddy on Zocor, Mama on Vytorin, brother (49 y.o.) on Lipitor. My brother’s doctor has him convinced him several years ago that it will protect him from the heart disease that runs rampant in my family.

    I’m (43 y.o. female) the only hold-out, I guess. But then again, I’m the only one with normal bloodwork by this age.

    A sad commentary on medicine these days. I’m glad to hear that you’re holding out.

    Cheers–

    MRE

  3. I wish this information was more well known. Many people think this is the only choice for them when most cholesterol numbers are poorly interpreted and considered alone as the only important part of the picture.

    How true, how true.

    Best–

    MRE

  4. How much longer will the Cholesterol Theory go on before the mainstream catches on and realizes it has no scientific validity?

    Probably for as long as there are $30 billion of statins sold per year. The drug companies would be loathe to lose out on that money, which they would do if the cholesterol theory were to be proven false. The pharmaceutical industry has a vested interest in keeping the cholesterol theory alive as long as possible.

    Cheers–

    MRE

  5. Thank you for this. Always heartening to hear instances of what the pharma companies are up to. I’ve been gathering information now for 18 months, since my husband’s short-term memory has been destroyed by our own doctor pushing Lipitor (and attempting to push Crestor).
    It seems to me, as memory is central to intelligence, that the gross over-prescribing of statins for greed and profit is tantamount to attempted manslaughter, and I cannot understand why families whose lives are being destroyed are not taking doctors through the Courts.

    All they’ve got to do is find the right lawyer and they’re in business. Problem is that most of the lawyers are probably on statins themselves.

    Best–

    MRE

  6. Dr. Eades, feel free to delete this comment after reading it…

    You want to use “versus” in the last paragraph, not “verses.”

    Also, thanks for writing a fantastic blog. I read every new post the day it surfaces.

    Thank you!

    Hey Brian–

    Thanks for the heads up. The correction is made. It was a slip of the finger, not a slip of the brain.

    I’m glad you enjoy the blog. And I’m glad that you proof read better than I do.

    Cheers–

    MRE

  7. http://spacedoc.net/

    Dr. Duane Gravelines comprehensive list of cholesterol lowering drugs and their side effects. Himself suffered amnesia from taking Lipitor.

    Thanks for the link. I’m sure many will find it of interest.

    Best–

    MRE

  8. I’m a 61 y.o. female who doesn’t go to doctors very often. I have high cholesterol, normal tricglycerides, normal blood pressure, and normal weight. Early this year, I had a doctor (a DO) try to put me on Lipitor and tell me that if I refused, I would have to sign a release saying I wouldn’t blame him if I had a heart attack. A few months later, I had extensive lab tests done through the wellness program sponsored by my health insurance plan. The tests were reviewed by another DO, who tried to scare me into thinking I was on the verge of a heart attack. He was sure I would have to take Vytorin 10/20 plus pharmaceutical-grade niacin for the rest of my life. I avoided that, and a few months later went to a third doctor (a homeopathic practitioner as well as an MD) who looked at the same lab results as the second DO, and, pointing out the very low C-reactive protein and good ankle-brachial index, told me I didn’t have any more chance of having a heart attack than the average 61-year-old. I was glad to hear that, but this doctor had his own program (bio-identical hormones) and he wanted me to do about $800 worth of lab tests that my insurance plan wouldn’t cover since he’s not a preferred provider, so I haven’t gone back. I’m not quite on the Protein Power diet, though I get close to the Hedonist level if I don’t go overboard on chocolate. While I would just as soon have a regular doctor, I wouldn’t have a lot of confidence in one who insists on statins. But I have a couple of recommendations to try the next time I decide to break down and get a checkup.

    Hi gz–

    If you really want to see what your cardiovascular status is from a plaque standpoint, spring for an EBT and get a calcium scan. If your calcium scan is a zero, then you don’t have to worry. And these EBT scans are getting cheaper by the day.

    Cheers–

    MRE

  9. Just remember. Their goal is 50% of people over 50 on a statin.

    I’ve never heard this stated as such, but I wouldn’t be surprised.

    Cheers–

    MRE

  10. (Note to beth: I think they want 100% of people over 50 on statins….)

    We have taken to referring to those obnoxious ads for Lipitor featuring “you-know-who” as being from the Lipi-whore.

  11. Regarding EBT scans, I looked up the topic on Google and read an informative 5-page article: EBT (Ultrafast CT) Scans – Godsend, or Scam? Dr. Fogoros says that false positives (where the EBT shows the presence of calcium, but the patient has little coronary artery blockage) occur about 50 percent of the time. The next step, if the EBT is positive, is to do a heart catherterization to find out whether there actually is coronary artery blockage. So the odds are that I’d have to worry!

    The info you got from Google is one of the reasons one shouldn’t get medical information online. As far as I’m concerned the EBT is the BEST way to determine the presence of plaque. If you have a positive calcium score, you have plaque, and there’s an end on’t (as Samuel Johnson would say). Now you may have a low calcium score for your age or you may have a calcium score that doesn’t change, which means you have stable plaque, but if you have a positive calcium score, you have some amount of plaque in your coronary arteries.

    And whoever says that the next step to take if you receive a positive calcium score is a coronary artery cath is a real moron. That’s probably the last thing you would want to do if you are asymptomatic. All the cath procedure does is shows whether or not you have a blockage – you can have huge amounts of plaque (which are a disaster waiting to happen) and have a normal cardiac cath.

    If you want to get a little more information on the validity of EBT than what you find on Google, take a look at Dr. Davis’ blog or get a copy of his book: Track Your Plaque. I’m not crazy about all of Dr. Davis’ dietary recommendations because he comes to diet from a different perspective than I, but the EBT info in his book is terrific.

    Cheers–

    MRE

  12. Thanks for the additional info on EBT. I’m wondering, if I were to get two EBT scans, say six months apart, and they showed the same calcium score (supposing I do have some calcium, which wouldn’t surprise me), would that be an indication that the plaque is stable? Is six months a reasonable interval?

    If the calcium score is reasonably low, then a year would be a good interval. If there is no change in calcium score it would imply stable plaque. I forgot to link in the last answer to Dr. Davis’ blog, which contains a wealth of information. Here it is.

    Cheers–

    MRE