Neurontin - The Illegal Creation Of The Drug

Neurontin is not an illegal drug, however, Parke-Davis, the original drug manufacturer, a subsidiary of Warner-Lambert, illegally promoted the drug to prescribing physicians for at least 11 unapproved medical conditions. Many of the bases for the 11 unapproved uses of Neurontin appear to be fabricated by the company, itself. This included paying physicians to appear as the authors of medical journal articles on the unapproved uses for the drug, when the articles were actually been written by the company’s marketing department. Parke-Davis was acquired by Pfizer, Inc., in 2000.

Neurontin is currently approved by the FDA as supplementary treatment for partial seizures and shingles.

The 11 unapproved and illegally promoted uses of Neurontin include;

Bipolar Disorder

Psychiatrists were told that early clinical trials indicated a 90 % response rate in the treatment of bipolar disorder by Neurontin. However, the only type of clinical trial being conducted at the time was a pilot study. No such results actually existed. Most of the published reports on the use of Neurontin in bipolar disorder have been written and sponsored by Parke-Davis.

Pain Syndromes, Peripheral Neuropathy, and Diabetic Neuropathy

Parke-Davis medical liaisons were instructed to report that clinical trials demonstrated Neurontin was highly effective in treating a number of pain syndromes. And that a 90 % response rate was being reported in the management of pain. Again no such evidence existed. The only bases for these claims were anecdotal evidence of minimal scientific value.

Treatment Of Epilepsy - Monotherapy

Medical liaisons were also encouraged to push neurologists to prescribe Neurontin as the only drug to treat epilepsy. This is in spite of the fact that studies found it safe and effective only when used in combination with other seizure drugs. Neurologists were duped into believing that substantial evidence supported this claim.

In 1997, the FDA rejected the company’s application for approval of Neurontin as monotherapy in the treatment of seizures.

Reflex Sympathetic Dystrophy

Physicians were informed again by medical liaisons that extensive evidence existed that demonstrated the efficiency of Neurontin in treating RSD. Again, the only evidence was in anecdotal reports of little or no scientific value.

Attention Deficit Disorder

Pediatricians were told that Neurontin was an effective treatment of ADD. No hard data existed however to support this claim.

Restless Leg Syndrome

This is another condition which medical liaisons were trained to lie about. No real or substantial scientific data actually existed.

Trigeminal Neuralgia

Parke-Davis also reported that Neurontin could be used as a treatment for trigeminal neuralgia, a syndrome of severe bursts of facial pain. However again no scientific data supported this claim, only the occasional anecdotal report.

Post-Hepatic Neuralgia

Physicians were told that 75 to 80% of all PHN patients were successfully treated with Neurontin, when no real clinical trial data supported such claims.

Essential Tremor Periodic Limb Movement

No scientific data supported this claim that Neurontin was effective for Essential Tremor Periodic Limb Movement.

Migraines

Claims were also reported that Neurontin was effective in treating migraine headaches. Pilot studies had been suggested and undertaken, but no early results existed to support this claims.

Drug and Alcohol Withdrawal Seizures

It was also suggested that Neurontin could treat drug and alcohol withdrawal seizures, even though there was no evidence to prove this.

Parke-Davis constantly lied and concocted fake evidence of clinical trials for the above mentioned conditions. And last year in May 2004, Warner-Lambert, admitted it aggressively marketed Neurontin by unlawful and illegal means for unrelated conditions. The company has to pay $430 million dollars in penalties. Pfizer, the now owner of Neurontin released a statement which declared that original allegations and related investigations had originated for Neurontin in 1996, well before Pfizer acquired the company of Parke-Davis.