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Neurontin Off-Label Promotions Case
To view the Pfizer emails and documents released in October 2008, click here
Neurontin is the brand name for the drug gabapentin and is a widely prescribed anti-convulsant approved by the Food and Drug Administration (FDA) for the treatment of epilepsy. Warner-Lambert Company (Warner) has manufactured and sold the brand name prescription drug Neurontin since its approval by the FDA on December 30, 1993 . Warner marketed Neurontin through its Parke-Davis division. Warner was acquired by Pfizer in June of 2000 and is presently a wholly owned subsidiary of Pfizer.
PAL Member Litigation
In February 2003, PAL members filed suit against Pfizer and Parke-Davis alleging that they illegally and fraudulently marketed the drug Neurontin for uses that have not been approved by the Food and Drug Administration (FDA). Specifically, the lawsuit alleges that the pharmaceutical companies circumvented FDA regulations requiring them to get approval for any new uses of a drug by engaging in a marketing scheme to promote the drug for "off label uses."
In 2000, when Parke-Davis was acquired by Pfizer, Inc, the only FDA approved use for Neurontin was as an add-on treatment for epilepsy. This is a very limited market with little upward sales potential. According to the suit, Parke-Davis knew that pain management, psychiatric disorders, anxiety and depression, all off-label uses, were immense markets, which if tapped, could yield enormous profits from sales of Neurontin. The company decided that it would be faster and less expensive to avoid the FDA's drug approval process and promote Neurontin for unsubstantiated uses.
Company officials developed a strategy that would allow Parke-Davis to avoid the costs of proving Neurontin's safety and effectiveness for these other uses, while allowing the company to enter the lucrative off-label markets. The company used a variety of manipulative and fraudulent tactics to build sales of the drug, including:
- A "publication strategy" that allowed it to promote Neurontin by the massive distribution of articles written by technical writers hired by the company. These articles supposedly described the scientific evaluation of Neurontin for off-label uses. Parke-Davis paid honoraria to physicians for the use of their names on these articles, even though the physicians were not involved in preparing the articles.
- Holding "consultants'" meetings at which doctors were paid to hear - either from company employees or physician speakers hired by the company -- lengthy presentations relating to Neurontin, particularly regarding off-label usage. Parke-Davis also routinely tracked these "consultants'" Neurontin prescription writing practices after these meetings.
- Payment of kickbacks to physicians to hear off-label promotion of Neurontin at programs billed as Continuing Medical Education (CME) seminars. Every aspect of these conferences and seminars was designed and approved by Parke-Davis, despite requirements that these sorts of seminars be developed independent of the drug manufacturer.
- Outright payments, in the form of grants, to reward demonstrated physicians who actively prescribed Neurontin.
- The formation of a Speakers' Bureau, which paid physicians to give presentations advocating for the use of Neurontin.
As a result of this broad-ranging marketing scheme, sales of Neurontin in 2000 were 1.3 billion, and they grew to $1.7 billion; nearly 80% of these sales were for off-label use.c
The consumer organizations that brought the suit are: California Public Interest Research Group (CALPIRG), Congress of California Seniors and USAction. This case was filed under section 17200, et seq. of California 's unfair competition and false advertising statutes (Cal. Bus. Prof. Code §§ 17200-17208 and 17500-17572) which regulate the conduct of businesses and their transactions with consumers.
Update: Following the passage of a state referendum (Proposition 64) that changed the requirements for bringing a case under California's consumer protection statute, the defendants filed a motion to dismiss the complaint. Unfortunately, on March 22, 2005, the court granted this motion, ruling that the referendum applies to cases previously filed in California state court, and dismissed the case. On April 21, 2005 the Plaintiffs filed a motion for leave to file a second amended complaint. The case has been stayed (put on hold), awaiting the results of the appeals in two unrelated California state court cases that will determine the effect and scope of Proposition 64 on cases such as this one, and also awaiting a decision on whether a national class is certified in another Neurontin off-label case before the U.S. District Court for the District of Masschusetts. .
Court: Superior Court of California, County of Los Angeles (Judge Mohr)
Massachusetts case: There is also a proposed national class action pending in the U.S. District Court for the District Court of Massachusetts. While PAL members are not directly involved in that case, we have been tracking its progress. In October 2008, the plaintiffs filed expert reports with the Court that included a number of very revealing documents and emails produced by Pfizer. These documents allegedly show that Pfizer sought to manipulate the results of clinical trials of Neurontin for "off-label" uses, by failure to report the results of those studies or changing the conclusions.
In order to educate the public, Prescription Access Litigation has posted these documents online:
- Revised Supplemental Declaration of Ilyas J. Rona Filed In Support Of Plaintiffs’ Renewed Motion For Class Certification – this document describes the Exhibits (expert reports and Pfizer documents) that were filed with the Court. (The descriptions below of the Exhibits are taken from this Declaration.)
- Exhibit A: Parke-Davis memorandum from the Neurontin Marketing Team to the Field Sales Colleagues dated November 30, 1998, ―designed to explain why the Neurontin articles are able to be distributed by territory sales managers.
- Exhibit B: A memorandum from Pat Woster, Chair of the Parke-Davis Central Nervous System Specialty Group, to Medical Liaisons and Associate Medical Directors dated May 16, 1999, listing ―Articles for Distribution relating to the indications that are in this case. For example, one article ―supports the use of gabapentin and pregabalin for treatment of neuropathic pain. Other articles concerned ―acute mania,‖ ―Neuropathic pain after anti-HIV gene therapy, and ―bipolar disorder.
- Exhibit C: CME Guidelines for the Distribution of Educational Materials relating to Parke-Davis CME initiative entitled ―Advances in the Preventative Treatment of Migraine. The guidelines recognize ―that perhaps the most powerful means of promotion is direct contact and encourage ―Parke-Davis sales representatives to participate in raising awareness by distributing copies of the information brochure to appropriate physicians in their areas
- Exhibit D: PFIZER_CGROGAN_0022377, which is a Pfizer email from Christine Grogan to Lance Tyler dated April 26, 2001. The email states: ―Our [Review Committee] has allowed [sales] rep distribution of CME program invitations if the accrediting body has sent a written request asking for such support/help.
- Exhibit E: A Pfizer document entitled ―Neurontin Action Plan – POA2 – 2004 relating to Pfizer’s goals, strategies and messages for 2004. Under strategies, the document states: ―No calls on Psychs!!!!
- Exhibit F: Declaration of Meredith Rosenthal: Estimate of Units Paid for by Neurontin Endpayers that Resulted from Alleged Fraudulent Marketing by Defendants dated August 11, 2008
- Exhibit G: Declaration of Raymond S. Hartman dated August 11, 2008
- Exhibit H: Expert Report of Kimberly P. McDonough dated: August 11, 2008
- Exhibit I: Expert Report of Nicholas P. Jewell, Ph.D. dated: July 29, 2008
- Exhibit J: Expert Report of David A. Kessler, M.D. dated July 31, 2008
- Exhibit K: Report on the Use of Neurontin for Bipolar and Other Mood Disorders prepared by Jeffrey S. Barkin, M.D. dated July 25, 2008.
- Exhibit L: Neurontin: Clinical pharmacologic opinion of Dr. Thomas L. Perry dated August 10, 2008. 14.
- Exhibit M: Report on gabapentin (Neurontin®) for migraine prophylaxis: evaluation of efficacy, effectiveness and marketing prepared by d. Douglas C. McCrory, M.D., M.H.Sc.
- Exhibit N: the Expert Report of John Abramson, MD dated: August 11, 2008
- Exhibit O: Expert report entitled “Reporting and other biases in studies of Neurontin for migraine, psychiatric/bipolar disorders, nociceptive pain, and neuropathic pain” prepared by Kay Dickersin, Ph.D., MA
- Exhibit P: the Consultant Report Prepared by: Brian Alldredge, PharmD
- Exhibit Q: A Pfizer memorandum from Hank McCrorie—the former Executive Vice President in charge of US Sales—to all sales representatives informing them that ―a number of decisions have been made relevant to the promotion and marketing of Neurontin…,including the instruction that ―Neurontin detailing responsibility will be limited only to the US RON sales force (approximately 150 representatives). RON representatives will call only on Neurologists for Neurontin.