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Neurontin was approved for sale in the mid-1990s as a treatment for epileptic seizures. But a lawsuit brought under the False Claims Act (settled in May 2004) by a former employee alleges that Parke-Davis (now owned by Pfizer) has made most of its money off the drug by marketing it to doctors for unapproved uses, in an illegal practice known as "off-label marketing."

Doctors are free to prescribe a drug for unapproved uses, but under FDA law, a company is not allowed to promote a prescription drug for a medical condition without first proving to the FDA that the drug works for that condition and is safe.

The whistle-blower, David Franklin, a fromer salesman, alleges that the company had a systematic strategy to promote Neurontin for untested uses, such as chronic pain, bipolar disorder and migraine. Franklin, who is suing in federal court in Boston, claims internal documents show the company promoted these uses by paying doctors to attend so-called educational meetings at lavish restaurants and resorts.

Pfizer has declined to comment on the details of the whistle-blower lawsuit, and says it does not engage in off-label marketing practices.

Neurontin continues to be sold mostly for unapproved uses. By Pfizer's own admission, 80 percent of Neurontin's sales are for those uses.

Excerpt from November 2004 Trial Magazine article:

"Harris Pogust, cochair of ATLA’s new Neurontin Litigation Group, said his firm in Pennsauken, New Jersey, has filed two such cases and sees potential clients daily. The harm done by Neurontin’s off-label use, he noted, extends well beyond suicide. The drug company conducted two clinical trials on Neurontin’s use as a treatment for bipolar disorder, he said. One showed that a placebo was as good as Neurontin; the other showed that the placebo worked better than the drug. But the company continued to promote Neurontin as an off-label treatment for bipolar disorder.

Pogust compared Parke-Davis’s conduct to “coming into the house of a bipolar patient on lithium,” removing the lithium from his or her medicine cabinet, “and saying, ‘You’re not going to be medicated. See what happens.’”

and:

"Using tape-recorded messages and other evidence that Franklin had accumulated, the suit detailed how Parke-Davis instructed its medical liaisons to ask doctors leading questions so the liaisons could talk about off-label uses. The company also provided grants and all-expenses-paid junkets to doctors who promoted the drug or prescribed it often. And, the lawsuit claimed, Parke-Davis hired a third party to ghostwrite scientific articles boosting Neurontin, then paid doctors to attach their names as bylines to the articles, which were published in medical literature."

Basically you are in the hands of your doctor who may or may not have all of the information to determine if the drug is safe for you and whether or not it is really effective in treating your condition.