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  • Pfizer looses with Neurontin

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    Old 05-14-2004, 08:28 PM   #1
    sirsickalot
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    Pfizer looses with Neurontin - a must read

    Pfizer Inc., the world's largest pharmaceutical company, has agreed to plead guilty and pay more than $430 million to settle all criminal charges and civil liabilities related to the illegal and fraudulent promotion of unapproved uses for its top selling epilepsy drug Neurontin by Warner-Lambert's Parke-Davis Division, the Justice Department said in a prepared statement issued on Thursday.

    "The Department of Justice is committed to rooting out and prosecuting health care fraud," said Associate Attorney General Robert McCallum. "The Department's commitment to effective health care fraud enforcement is driven by a mandate that wrongdoers be brought to justice, to deter conduct which threatens the safety and welfare of all Americans, and the need to protect the resources of the Medicare Trust Fund, state Medicaid programs, and other government health programs."


    Neurontin
    =======
    Neurontin was approved in 1993 for the treatment of partial seizures with and without secondary generalization in adults with epilepsy. In 2002, Pfizer received approval for Neurontin for treatment of post-herpetic neuralgia.

    Once approved, the drug may not be marketed or promoted for so-called "off-label" uses - any use not specified in an application and approved by the Food and Drug Administration.


    Off-Label Uses
    ==========
    However, Warner-Lambert's strategic marketing plans, as well as other evidence, show that Neurontin was aggressively marketed to treat a wide array of ailments for which the drug was not approved, the Justice Department said. The company promoted Neurontin for the treatment of bipolar mental disorder, various pain disorders, Lou Gehrig's Disease, attention deficit disorder, migraine, drug and alcohol withdrawal seizures, restless leg syndrome, and as a first-line monotherapy treatment for epilepsy (using Neurontin alone, rather than in addition to another drug).

    Warner-Lambert promoted Neurontin even when scientific studies had shown it was not effective, the Justice Department said. For Example, the company falsely promoted Neurontin as effective for treating bipolar disease, even when a scientific study demonstrated that a placebo worked as well or better than the drug.

    "This illegal and fraudulent promotion scheme corrupted the information process relied upon by doctors in their medical decision-making, thereby putting patients at risk," stated U.S. Attorney Michael Sullivan.

    Last edited by sirsickalot; 05-14-2004 at 08:33 PM.

     
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    Old 05-15-2004, 07:25 AM   #2
    Shoreline
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    Re: Pfizer looses with Neurontin

    Hey Guys, Before the folks on Neurontin panic, please note that the FDA did aporove this drug for post herpetic neuralgia. A very panful neurologic disorder. It's not that it doesn't work on nerve pain, It's the way it was marketed for so many off label uses. The manufacturer reps are not aloud to call on docs and suggest off label purposes for this med.

    So A nurontin rep would likely have no reason to even be in a psychyatrists office selling the doc on the idea it's a great new treatment for bipolar disorder which has no clinical data backing the claim. Use of drugs for off label purposes in itself is not illegal. But the manufacturer can not market their FDA aproved drug for other off label purposes.
    Take care and Thanks for the update sirsickalot.

    I was talking to my mom this morning about her optons with breast cancer. The oncologist were not happy about the continued use of soy estrogen to manage menapause. Soy estrogen is supposed to be safer but any form of estrogen can increase the risk of breast cancer. So what the doc said they recomend now is the use of a SSRI's like paxil. I jokingly said to my mom, is there anything paxill can't cure. She got a chuckle and understaood what I meant. Now we have endocrinologist using paxil for hormomne stabilization. What's next, increased gas mileage from paxil. Drop a pink pill in the old gas tank and get 100 miles to the gallon. Why not, it hasn't been disproven.LOL

    Take care, Dave

    Last edited by Shoreline; 05-15-2004 at 07:29 AM.

     
    Old 05-15-2004, 12:51 PM   #3
    sirsickalot
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    Thumbs up Re: Pfizer looses with Neurontin

    Thanks Dave. I hesitated to even form an opinion until I got your side of the situation. I appreciate your reply. I have a lot of respect for you and always take great reguard in your input.

    Rich

    Last edited by sirsickalot; 05-15-2004 at 12:52 PM.

     
    Old 05-15-2004, 01:00 PM   #4
    Shoreline
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    Re: Pfizer looses with Neurontin

    Hey Rich, That's giving me alot more credit than I diserve. It is a nice compliment though. The situation allows me to be a sarcastic smart [email protected]# without anyone taking offense.LOL
    Take care, Dave

     
    Old 07-06-2004, 08:36 AM   #5
    ELDERPANTHER
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    Re: Pfizer looses with Neurontin

    Has anyone doc taken them off Neurontin due to this ruling?

     
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