A major story broke today in the New York Times, Wall Street Journal and Boston Globeabout Pfizer’s (NYSE:PFE) alleged manipulation of studies of its epilepsy drug Neurontin:

See:

• Keith Winstein’s Suit Alleges Pfizer Spun Unfavorable Drug Studies in the WSJ
• Stephanie Saul’s Experts Conclude Pfizer Manipulated Studies in the NY Times).
• Liz Kowalczyk’s E-mails suggest Pfizer tried to suppress study on drug in the Globe

The studies examined whether Neurontin was effective for conditions other than epilepsy. As the NY Times article describes,

Pfizer’s tactics included delaying the publication of studies that had found no evidence the drug worked for some other disorders, “spinning” negative data to place it in a more positive light, and bundling negative findings with positive studies to neutralize the results, according to written reports by the experts, who analyzed the documents at the request of the plaintiffs’ lawyers.

Neurontin has been an extraordinarily profitable drug for Pfizer, and most of the prescriptions written for it were not for epilepsy, but were “off-label” (prescribed for a use not approved by the FDA). In 2004, Pfizer paid $430 million to settle a criminal and civil case brought by federal prosecutors that charged that Warner-Lambert, which Pfizer acquired in 2000, had illegally promoted Neurontin for “off label” purposes in the 90s.

That $430 million settlement reimbursed state and federal health care programs (like Medicaid) that had paid for off-label prescriptions of Neurontin, but did not compensate consumers or “third party payors” (health plans, union benefit funds and others) that had also paid for such prescriptions. A number of class action lawsuits were brought against Pfizer, and they were consolidated in the U.S. District Court for the District of Massachusetts. The ongoing lawsuit is In re Neurontin Marketing and Sales Practices Litigation, MDL #1629, Docket #04-10981.

That case has been pending for several years, with the parties exchanging documents and arguing before the Court about whether a national class of consumers and third party payors can be “certified,” which is the prerequisite to the case going forward as a class action.

The documents that were recently released were part of “expert reports” submitted by the lawyers for the plaintiffs in the case. The reports both contain and analyze documents from Pfizer about its alleged illegal offlabel promotion of Neurontin.

Now that the reports and documents have been filed with the Court, they are a matter of public record. We here at Prescription Access Litigation subscribe to the maxim that “sunlight is the best disinfectant.” We are posting these reports and documents in their entirety so that the public can see them for themselves. They paint an interesting picture.

• 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.

Note: There is a separate class action lawsuit in Calfornia state court against Pfizer for the same alleged off-label marketing of Neurontin in California, brought by several members of Prescription Access Litigation’s coalition. To read more about that suit, and the underlying allegations (which are the same as in the Massachusetts case), go here.