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Neurontin® Off-Label Promotions Case
And it’s Potential Impact on Pfizer
In June of 2002, the Prescription Access Litigation (PAL) filed a suit against Pfizer and Parke-Davis, the manufacturers of Neurontin®, claiming that the medication was being marketed and used for “unapproved” treatment of other diseases. ...
Neurontin® is the brand name for the drug gabapentin, which has been approved for the use and treatment of seizures seen in epilepsy. Some of the “off-label” (unapproved )medical conditions that Neurontin® was used to treat were most notably bipolar disorder, diabetic neuropathy, migraines, panic disorders, Attention Deficit Disorder, and Restless Leg Syndrome. Neurontin® first gained approval in December of 1993, which gave the company patent rights to its uses through January 2001, thus allowing generic companies to manufacture cheaper medication and ultimately pulling profits away from Pfizer/Parke-Davis.
Company History
Warner-Lambert Company has manufactured and sold Neurontin® since it received FDA approval in 1993. ... Total sales of Neurontin® have exceeded $1. ... Neurontin® sales totaled $812 million in the first half of 2001. ...
Neurontin® (gabapentin) History
Neurontin® is currently approved for supplementary treatment for specific types of seizures, known as partial seizures, usually suffered by epileptics. ... Neurontin® has been studied since 1983 and reached FDA approval status in 1994. ... Doctors and their patients have found Neurontin® to be effective in illnesses such as:
• Reflex Sympathetic disorder
• Brain injuries
• Situational and clinical depression
• Mood disorders
• Social phobias
• Bipolar disorder
• Periodic Leg Movement
• Restless Leg Syndrome
• Essential tumors
• Sleep dysfunction
• Interstitial Cystitis
• Muscle cramps
• Inflammatory injuries
• Cocaine dependence
• Neuropathic pain
• Trigeminal neuralgia
There are claims that Neurontin® has the potential to be a “world-class” antihyperalgesic agent (pain killer).
Neurontin® “Off-Label” Studies and Results
A psychiatrist from Texas, Dr. Seastrunk, became one of the first doctors to successfully use Neurontin® to treat patients suffering from Chronic Fatigue Syndrome (CFS) and Fibromyalgia Syndrome (FMS). ... Seastrunk claims that there is a focal brain injury that Neurontin® has helped minimize. ... Since Neurontin® is excreted through the kidneys, it was important that the creatinine levels of the patients were normal. ...
Neurontin® was found to be totally flushed from the body in approximately four hours. ... On the other hand, Magnesium has been found to compete for specific receptor in the brain that Neurontin® targets, and should not be taken. Since magnesium has antacid properties and will interfere with the absorption of Neurontin®, it has been suggested that all other medications that lessen gastric motility and acidity be avoided as well. ... Some of the side effects seen by users of Neurontin® have been dizziness, brainfog, ataxia, and visual problems. ...
Medical liaisons were also encouraged to promote Neurontin® as the monotherapy for the treatment of epilepsy. Neurologists were told that substantial evidence has been reported for the treatment of seizures associated with epilepsy by using Neurontin alone. Again doctors were led to believe that there was supportive evidence to prove effective treatments, when in fact the clinical trial showed Neurontin® to be ineffective and tests were inconclusive at best. Many patients could not continue treatment on Neurontin® alone. ... The Plaintiffs claim the defendants decided that they were going to ignore any normal regulatory FDA process and market the drug illegally, and conceal any illegal means, which would be employed to promote off-label use of Neurontin®. ... In this suit, the defendant claims that Pfizer hired medical liaisons to actively solicit doctors and promote off-label treatment with Neurontin®, and used cash payments as rewards and incentives. ...
The medical liaisons were trained on how to use the false information to persuade doctors on the “off-label” uses of Neurontin®. They would often remind the doctors that Neurontin® is very safe at high doses, and that studies are showing positive feedback in controlling bipolar mental disorder, monotherapy for seizures and treatment for various types of pain. ...
Parke-Davis had also concocted a plan to hand out cash incentives to physicians who wrote out the most prescriptions for Neurontin® and who may have participated in various other promotional ways.
Approximate Word count = 3283
Approximate Pages = 13.1
(250 words per page double spaced)
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