There's been some controversy lately about Neurontin (gabapentin), a medication that is being prescribed off-label for prevention of cluster headaches and Migraine attacks. It's important to recognize what the controversy actually entails and be able to separate it from the clinical information about Neurontin.
Neurontin is one of a class of medications called by several different names including antieiplepsy medications (AEDs), anticonvulsant medications, and neruonal stabilizing agents. Other medications in this class include Depakote (divalproex sodium), Topamax (topiramate), Keppra (levetiracetam), and others.
There has been only onedouble-blind, placebo controlled study of Neurontin for Migraine prevention.¹ At the end of the 12-week treatment period, completed by 100 participants, the median four-week Migraine rate forthe Neurontingroup decreased from 4.2 to 2.7 as opposed to4.1 to 3.5 for the placebo group.
Possibly because there have not been more trials of Neurontin, it is often not ranked as one of the first preventives doctors prescribe. In one journal article on Migraine preventive treatment, Neurontin was listed in the second category of: "Medications with lower efficacy (i.e. limited number of studies, studies reporting conflicting results, efficacy suggesting only 'modest' improvement) and mild-to-moderate adverse reactions."²
Despite the limited number of studies, Neurontin has been successfully used as a Migraine and headache preventive for some time now. Since it is not FDA-approved for the prevention of Migraine, it is prescribed off-label. This is a common practice. Physicians often prescribe medications for conditions for which they're not approved by the FDA. This is one vital way medications are found to treat various conditions, and it often leads to clinical trials of medications for conditions other than that for which they were first intended. Almost all of the medications prescribed for the prevention of Migraine and other head pain disorders are prescribed off-label. The only medications approved by the FDA for this purpose are Depakote and Depakote ER, Inderal (propranolol), and Blocadren (timolol).
A current investigation goes back to 1996 when David Franklin, Ph.D.,a former employee of Warner-Lambert, the original manufacturer of Neurontin, says that the company paid him, "to deceive, to lie to doctors." He was employed by the company as a medical liaison between the company and physicians, to "enable the doctor to practice the best possible medicine that science would allow at this point in time. Doctors were to contact him with questions about the company's products. He asserts that he was told to tell doctors that the company was receiving data about Neurontin's success in treating bipolar disorder and encourage doctors not seeing that success to drastically increase patient dosages. When interviewed by Dateline NBC, Dr. Gary Sachs, director of the Bipolar Treatment Center at Massachusetts General Hospital, said that two double-blind studies of Neurontin for bipolar disorder showed it to be totally ineffective for the condition. Franklin shared this recorded voicemail from his supervisor: “You know there’s a Neurontin push that’s supposed to be on.... So what we need to do is focus on Neurontin, when we get out there - we want to kick some ass on Neurontin - we want to sell Neurontin on pain all right? And monotherapy...I don’t know if you guys are embarrassed, but I’m embarrassed with where we are with Neurontin.”
There are also other allegations that doctors were essentially "paid" to prescribe more Neurontin — paid with medical presentations scheduled in places such as Yankee Stadium, cruise ships, and others. The United States Justice Department has filed suit against the current owner of Neurontin, Pfizer, for "an illegal off-label marketing scheme that is rife with false statements and fraudulent conduct..."
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