Discussion in 'Fibromyalgia Main Forum' started by MJJBunny, Aug 2, 2003.

  1. MJJBunny

    MJJBunny New Member

    You mentioned in another post something about Neurontin and a lawsuit. For those of us not familiar with this, could you please explain?
  2. Mikie

    Mikie Moderator

    The FDA approves specific meds for specific uses. It has long been a practice for docs to prescribe these meds for other uses for which they have found them to be useful. This is called off-label uses. The FDA has not encouraged this, but has not taken action against it either. Off-label use contributes to a large portion of the sales of some meds.

    Now, it seems that the makers of Neurontin sent a PhD into docs offices making claims for Neurontin which have not been substansiated. The PhD was introduced as "Doctor" and never told the docs he was visiting that he was not an M.D. He and the company which makes Neurontin pushed it's off-label use for bi-polar illness, a very common illness.

    One woman was taken off her Depakote, which had been working for her bi-polar disorder and put on Neurontin with disasterous effects when she became extremely manic. Neurontin is a safe medication and it was putting her on the Neurontin which was so dangerous; it was taking her off the medication which had been controlling her disorder. There is no evidence that Neurontin is effective in treating bi-polar disorder.

    The FDA has been investigating and finding all kinds of memos, cooperation from the PhD who posed as a "Doctor," and other evidence of wrongdoing in the name of profits. They are bringing suit agains the pharmaceutical comapny for this.

    Now, this is of great interest to all of us here because a lot of the treatment of our illnesses is from off-label uses of drugs originally designed for other purposes, including Neurontin which was originally designed as an anticonvulsant med. I think we are OK with this one because the FDA did give approval for its use in treating nerve pain.

    Klonopin, another anticonvulsant drug, is prescribed to help us sleep, for anxiety/panic attacks, to reduce sensory overload, and to help with muscle spasms like RLS. It also calms the racing brain and helps with tinnitus. I think we are OK with this one too because Dr. Cheney, a CFIDS expert, has said we suffer from a constant slight state of seizure which produces these symptoms.

    Guaifenesin is a mucus-thinning drug which is used to treat FMS as an off-label use. We will be OK with this too because it is available OTC--it is available here.

    The problem is that docs fearing the FDA is staring over their shoulders might just decide that it isn't worth it to prescribe meds for off-label applications.

    I am very angry that this company, in their greedy quest for profits, may have made it more difficult for us to get the treatments we need.

    Memory fails me, guys, was it on Dateline that this was revealed? I know that the info was available on a website for whatever show it was on, but it may be gone by now. I'm sure a little sleuthing on the www would turn up more info. I hope this helps.

    Love, Mikie
  3. MJJBunny

    MJJBunny New Member

    Thank you so much for the clue Mikie. Here is an article from the web:

    Neurontin Off-Label Promotions Case ("Neurontin II")
    Neurontin® Off-Label Promotions Fact Sheet

    Lawsuit Summary

    In February 2003, PAL filed suit against Pfizer and Parke-Davis alleging that they illegally and fraudulently marketed the drug Neurontin® for uses that have not been approved by the Food and Drug Administration (FDA). Specifically, the lawsuit alleges that the pharmaceutical companies circumvented FDA regulations requiring them to get approval for any new uses of a drug by engaging in a marketing scheme to promote the drug for off label uses.

    Neurontin®, the brand name for gabapentin, was originally produced by Parke-Davis, which was acquired by Pfizer, Inc. in 2000. The only FDA approved use for Neurontin® at that time was as an add-on treatment for epilepsy. This is a very limited market with little upward sales potential. According to the suit, Parke-Davis knew that pain management, psychiatric disorders, anxiety and depression, all off label uses, were immense markets which, if tapped, could yield enormous profits from sales of Neurontin®. The company decided that it would be faster and less expensive to avoid the FDA's drug approval process and promote Neurontin® for unsubstantiated uses.

    Instead, company officials developed a strategy that would allow Parke-Davis to avoid the costs of proving Neurontin®'s safety and effectiveness for these other uses, while allowing the company to enter the lucrative off-label markets. The company used a variety of manipulative and fraudulent tactics to build sales of the drug, including:

    A publication strategy that allowed it to promote Neurontin® by the massive distribution of articles written by technical writers hired by the company. These articles supposedly described the scientific evaluation of Neurontin® for off-label uses. Parke-Davis paid honoraria to physicians for the use of their names on these articles, even though the physicians were not involved in preparing the articles.
    Holding consultants meetings at which doctors were paid to hear either from company employees or physician speakers hired by the company -- lengthy presentations relating to Neurontin®, particularly regarding off-label usage. Parke-Davis also routinely tracked these consultants Neurontin® prescription writing practices after these meetings.
    Payment of kickbacks to physicians to hear off-label promotion of Neurontin® at programs billed as Continuing Medical Education (CME) seminars. Every aspect of these conferences and seminars was designed and approved by Parke-Davis, despite requirements that these sorts of seminars be developed independent of the drug manufacturer.
    Outright payments, in the form of grants, to reward demonstrated physicians who actively prescribed Neurontin®.
    The formation of a Speakers Bureau which paid physicians to give presentations advocating for the use of Neurontin®.
    As a result of this broad-ranging marketing scheme, sales of Neurontin® grew to $1.8 billion in 2000, 80% of which is off-label use.

    The consumer organizations bringing the suit are: California Public Interest Research Group (CALPIRG), Congress of California Seniors and national, grassroots consumer organization, USAction. This case was filed under section 17200, et seq. of California's unfair competition and false advertising statutes, Cal. Bus. Prof. Code §§ 17200-17208 and 17500-17572, which regulates the conduct of businesses and their transactions with consumers.