Drug maker to pay $430 million in fines, civil damages

FDA Consumer, July-August, 2004

Pharmaceutical manufacturer Warner-Lambert has agreed to plead guilty and pay more than $430 million to resolve criminal charges and civil liabilities in connection with its Parke-Davis division's illegal and fraudulent promotion of unapproved uses for the drug Neurontin (gabapentin). The drug was approved by the Food and Drug Administration in December 1993 solely for use with other drugs to control seizures in people with epilepsy.

Under the provisions of the Federal Food, Drug, and Cosmetic Act, a company must specify the intended uses of a product in its new drug application to the FDA. Once approved, the drug may not be marketed or promoted for so-called "off-label" uses--any use not specified in an application and approved by the FDA.

Warner-Lambert's strategic marketing plans, as well as other evidence, show that Neurontin was aggressively marketed to treat a wide array of ailments for which the drug was not approved, according to a recent press statement from the U.S. Department of Justice. The company promoted Neurontin for the treatment of:

* bipolar mental disorder

* various pain disorders

* amyotrophic lateral sclerosis (ALS), commonly referred to as Lou Gehrig's disease

* attention-deficit disorder

* migraine

* drug and alcohol withdrawal seizures

* restless leg syndrome.

The company also promoted the drug as a first line monotherapy treatment for epilepsy--using Neurontin alone, rather than in addition to another drug.

Warner-Lambert promoted Neurontin even when scientific studies had shown it was not effective. For example, the company promoted Neurontin as effecrive for use as the sole drug for epileptic seizures, even after solo use had been specifically rejected by the FDA. Similarly, the pharmaceutical company falsely promoted Neurontin as effective for treating bipolar disorder, even when a scientific study demonstrated that a placebo worked as well or better than the drug.

"This illegal and fraudulent promotion scheme corrupted the information process relied upon by doctors in their medical decision-making, thereby putting patients at risk," says U.S. Attorney Michael Sullivan. "This scheme deprived federally-funded Medicaid programs across the country of the informed, impartial judgment of medical professionals--judgment on which the program relies to allocate scarce financial resources to provide necessary and appropriate care to the poor. The pharmaceutical industry will not be allowed to profit from such conduct nor subject the poor, the elderly, and other persons insured by state and federal health care programs to experimental drug uses which have not been determined to be safe and effective."

As a consequence of the unlawful promotion scheme, patients who received the drug for unapproved and unproven uses had no assurance that their doctors were exercising their independent and fully informed medical judgment or whether the doctor was instead influenced by misleading statements or inducements from Warner-Lambert. Potential problems that can arise from off-label use without the benefit of careful FDA oversight include the occurrence of unforeseen problems because the drug was not studied in the type of patient it is being used for off-label, and the appropriate dosage and course of treatment have not been established.

Warner-Lambert used a number of tactics to achieve its marketing goals, including encouraging sales representatives to provide one-on-one sales pitches to physicians about off-label uses of Neurontin without prior inquiry by doctors. The company's agents also made false or misleading statements to health care professionals regarding Neurontin's efficacy and whether it had been approved by the FDA for the off-label uses. Warner-Lambert also used "medical liaisons," who represented themselves (often falsely) as scientific experts in a particular disease, to promote off-label uses for Neurontin.

Warner-Lambert paid doctors to attend so-called "consultants' meetings" in which physicians received a fee for attending expensive dinners or conferences during which presentations about off-label uses of Neurontin were made. These events included lavish weekends and trips to Florida, the 1996 Atlanta Olympics, and Hawaii. There was little or no significant consulting provided by the physicians.

The pharmaceutical company implemented numerous teleconferences in which physicians were recruited by sales representatives to call into a prearranged number where they would listen to a doctor or Warner-Lambert employee speak about off-label use of Neurontin. The company also sponsored purportedly "independent medical education" events on off-label Neurontin uses with extensive input from Warner-Lambert regarding topics, speakers, content, and participants.

Warner-Lambert misled the medical community beforehand about the content, as well as the lack of independence from the company's influence, of many of these educational events. In at least one instance, when unfavorable remarks were proposed by a speaker, Warner-Lambert offset the negative impact by "planting" people in the audience to ask questions highlighting the benefits of the drug.