Consumer Groups Accuse Makers of Epilepsy Drug Neurontin of End-Run Around FDA Regulations

LOS ANGELES – A broad coalition of consumer and public interest groups today announced that they have filed a lawsuit against Pfizer (NYSE:PFE) and its subsidiary, Parke-Davis, two of the nation's largest pharmaceutical companies, accusing them of circumventing FDA regulations to promote scientifically unproven 'off-label' use of their drug.

The lawsuit filed yesterday by Community Catalyst's Prescription Access Litigation (PAL) project on behalf of CALPIRG, the Congress of California Seniors and the national group, USAction. The suit alleges that in 1995 Parke-Davis decided that it did not want to undertake the clinical trials that FDA requires in order to approve new uses for a prescription drug. The company instead created an illegal promotional campaign to get more patients to use the drug, Neurontin, which had only been approved for epilepsy. Disguised as 'medical education' for the doctors or 'consulting' for the company, that campaign included illegal cash kickbacks to physicians and other sales ploys to pump up sales of the drug for non-FDA approved uses.

"We are outraged to find that once again a major drug company has decided it is above the law and can market its drug by any means necessary in this case, without taking steps to adequately test its drug," said PAL director Ahaviah Glaser. "Parke-Davis decided to put profits above good medicine. We're suing to highlight their corrupt corporate behavior and hold Parke-Davis and Pfizer accountable for making decisions based only on the financial bottom line."

The FDA gave Parke-Davis approval to market Neurontin as an epilepsy drug in 1993. Subsequently, the complaint alleges, the company concluded that the clinical trials required to get FDA approval for other uses would take too much time and money, especially since its patent was due to expire in 1998.

Rather, the company decided to launch a broad campaign to promote the drug for treating at least 13 separate conditions, including migraines, bipolar disorder and restless leg syndrome, the complaint alleges, by hiring outside firms to help exploit a loophole in government regulations that prohibit the promotion of drugs for unapproved uses, except in published research and medical education.

The complaint cites an internal Parke-Davis memo that reads: "Did it make sense for Parke-Davis to do rigorous and expensive clinical trials to prove to the FDA that Neurontin worked for the [other uses?] It did not." (par. 29)

Instead, according to the complaint, Parke-Davis recruited and paid numerous individual physicians to participate in sham studies that the company then publicized to persuade other physicians to prescribe Neurontin in doses far higher than FDA authorizes. In addition, the suit charges, the company paid physicians to attach their names to scientific articles promoting the off-label use of Neurontin, even though the articles were ghostwritten by third-party authors not by the doctors paid by Parke-Davis. FDA regulations require that such studies be independently authored.

The company's complete disregard for patient safety prompted three of PAL's member groups to file suit against the company.

"We put our trust in physicians, in our system for keeping them up-to-date on medicine, and in the regulators whose job it is to make sure the drugs that are so expensive for all of us are safe and effective," said Steve Blackledge of CALPIRG. "When a company buys physician endorsement of a drug, it destroys that trust. This dangerous, arrogant industry behavior must be stopped."

The suit contends that Parke-Davis also recruited physicians -- including those who wrote high volumes of Neurontin prescriptions -- to act as consultants to the company, paying them to attend meetings at hotels and resorts. In this scheme, physicians were not required to provide consulting services, but instead sat through presentations by the company which were designed to influence their prescription-writing behavior.

"We intend to show that Parke-Davis intentionally manipulated FDA exemptions intended to promote professional dialogue regarding pharmaceutical science to illegally promote off-label use," said Steve Berman, the lead attorney who filed the lawsuit on behalf of the plaintiffs.

The complaint notes that the off-label uses Parke-Davis promoted are not medically accepted by the American Hospital Formulary Service Drug Information, or any relevant peer-reviewed literature. Parke-Davis was acquired by Pfizer when it bought Warner-Lambert in 2000.

Parke-Davis was successful in its off-label strategy. Published reports state that 78 percent of Neurontin prescriptions had been written for treatments other than epilepsy, earning sales revenues of $1.3 billion.

The suit cites violations of the California Unfair Competition Law in the company's efforts to deceive consumers by managing the publication of misleading scientific articles and falsely and deceptively marketing Neurontin for uses for which no valid scientific data existed. The suit also asserts that Parke-Davis violated Untrue and Misleading Advertising sections of the California code.

The suit asks the court to order Pfizer to immediately stop promoting Neurontin off-label use, to disgorge the profits it received through illegal practices, and to publish notice of the truth regarding Neurontin. The litigation was filed in the Superior Court of the State of California for the County of Los Angeles. For more information about the suit including a copy of the complaint, visit www.hagens-berman.com and www.prescriptionaccesslitigation.com.

Prescription Access Litigation (PAL)
Since its launch nearly two years ago, the Prescription Access Litigation (PAL) project has filed 13 sets of lawsuits targeting drug industry practices that illegally push the price of prescription drugs beyond the reach of the American consumer. A project of Boston-based Community Catalyst, PAL is on the ground in 34 states and the District of Columbia; the coalition is comprised of 88 state, local, and national senior and consumer health advocacy groups fighting to make prescription drugs affordable.

Community Catalyst is a national health care advocacy organization dedicated to building consumer and community participation in the decisions that shape our health system. Working in partnership with state, local, and grassroots consumer groups in over 30 states, Community Catalyst has helped preserve over $16 billion in community health assets as hospitals and health plans around the country have become for-profit corporations. It works on a range of health care access issues, including today's struggle to preserve Medicaid services and other health programs amid plunging state revenues nationwide.

Congress of California Seniors
As an umbrella organization for hundreds of affiliated groups, CCS has a combined membership of over 650,000 Californians. This broad-based coalition includes a variety of senior advocacy organizations such as the California Legislative Council of Older Americans, Gray Panthers, International Senior Citizens Association (ISCA), and Older Women's League (OWL). In addition, CCS represents retired public employee organizations such as the California Federation of Teachers (ATF AFL-CIO), Retired Public Employees Association (RPEA), California School Employees Association (CSEA), the Retired Division of the California State Employees Association (CSEA), and the California Federation of the National Association of Retired Federal Employees (NARFE). Member organizations also include the Federation of Retired Union Members (FORUM), as well as retiree clubs representing many trade unions and international labor organizations.

California Public Interest Research Group CALPIRG is a 30-year-old organization that stands up and takes action when consumers are cheated and the voices of ordinary citizens are drowned out by special interest lobbyists. The organization has used the time-tested tools of investigative research, media exposes, grassroots organizing, advocacy, and litigation to protect consumers by encouraging a fair, sustainable economy and fostering responsive, democratic government.

USAction USAction is a national, grassroots consumer organization with over three million members and statewide affiliates in twenty-three states.

CONTACTS:
Steve Berman 206-623-7292
Hagens Berman
steve@hagens-berman.com

Laurie Covens 617-275-2805
Community Catalyst/PAL
covens@communitycatalyst.org

Renee Markus Hodin 617-275-2810
Community Catalyst
hodin@communitycatalyst.org

About Hagens Berman
Hagens Berman Sobol Shapiro LLP is an investor-rights class-action law firm with offices in 10 cities. The firm represents whistleblowers, workers and consumers in complex litigation. More about the law firm and its successes can be found at www.hbsslaw.com. The firm's securities law blog is at www.hbsslaw.com/blog/hagens-berman-blog.

Media Contact
Ashley Klann
206-268-9363
AshleyK@hbsslaw.com

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