Tuesday, January 27, 2009


Bextra Off-label Promotion Scheme Earns Pfizer Largest Fine in History

While most pharma-watchers have been reading Wyeth tea leaves, the company yesterday announced, almost as an aside, that it had settled a $2.3 billion fine for off-label promotion of Bextra. This dwarfs the recent Lilly/Zyprexa off-label fine, as it also does the liability Pfizer inherited from Warner-Lambert over off-label Neurontin promotion.

So what did Pfizer do to become #1 in off-label fines? For now, it appears that most of the details remain uncertain. However, our crack investigative team (Lil, Duane, and Suzette) noticed that Pfizer had earlier settled an off-label and otherwise illicit promotion charge over Celebrex and Bextra with the state of Alaska. A report of that settlement is below.

Same stuff? Lil, Duane, and Suzette can't confirm it. But at least we now know who won the Superbowl. So you are free to spend the weekend on other things.



  1. Pfizer just lost a battle; the Government is still helping Pharma win the war as Medicare has approved off label use cancer drugs.
    I realize there is a difference, when someone is prescribed an unapproved drug for cancer treatment it is usually because they at the point where standard therapies are not effective, however I don't believe that doctors are informing their patients that they are essentially guinea pigs and I don't believe any off label uses have proven effective.


  2. Hi Jim - If we're talking in general, I think nearly 50% of scripts written are for off-label applications. Certainly, many of them are effective if we're talking about that very large pool.

    As you know, companies sometimes deliberately do _not_ seek approval for an indication, saving it for the successor drug, even while doing everything possible to promote the initial drug off-label. Thus, have cake. Eat it too.

    That is part of the scuzzy Neurontin-Lyrica saga.

  3. Anonymous

    I made an over generalization that I could not support with facts; however a close friend of mine died recently and he was using combination therapy to treat his lung cancer and was never informed that the treatment was an unapproved protocol, he only found out when he looked up the specific drugs himself and found out the one drug, I don't recall which, was a stand alone therapy, but needless to say the therapy did not work and basically the quality of his life for his last months was terrible.


  4. Jim - I am sorry to hear about your loss. And I am shocked that your friend was not informed that he was, essentially, part of an experiment. Perhaps he would have agreed to go that way. But not to be informed is outrageous.

  5. Thanks Justice

    I don't know how prevalent the practice is but I agree he should have at least been informed. However, after he found out that one of his medications was recommended as a stand alone therapy he told the doctor to stop administering the other drug. He made this decision based primarily on his own assessment of his quality of life; while taking the two drugs he was treated on a weekly basis for a sustained period of time and his body was never given a chance to recover from the continued exposure to toxic medications.
    The sad thing was, he was diagnosed with lymphoma in 2003 and the Chemo cured the lymphoma but while on the lymphoma therapy he developed lung cancer. We used to joke that he was a statistical success because he survived more then 5 years after being diagnosed with lymphoma, however the statistics never look at the quality of life.

  6. Jim K I too am sorry for your loss. And of course because it was lung cancer I bet there was a certain amount of stigmatization associated with it...

    Doing a little research lately I can see that certain chemotoxic drugs actually increase oxidative stress which can potentially influence other cancers. The lungs are the most sensitive to this type of oxidative stress. I think however, you would be hard pressed to find the doctors and researchers speaking about this thing. It is sad too. Sometimes just adding a high dose of antioxidants might potentially combat this and actually keep patients on Chemo longer - but that is a bit too "new age" for some people - Pity actually...

  7. Thanks Former

    I assume the stigmatization you are referring to is smoking, and yes, Bob was a former smoker who had quit smoking seven years ago, an accomplishment of which he was most proud.
    As to the chemotoxic drugs; the lymphoma drug therapy did indicate the possibility of lung cancer and I am not sure if Bob's doctor told him this or he found this information on his own and then the doctor confirmed that there was a possibility that the lymphoma therapy caused his lung cancer.
    However, we will never know if Bob had not developed lymphoma if he would still have developed lung cancer, but getting back to your statement on stigmatization, I am almost certain that Bob's death certificate listed the primary cause of death as smoking related and not as a result of chemotherapy.



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