NARRATIVE REVIEW: THE PROMOTION OF GABAPENTIN: AN ANALYSIS OF INTERNAL INDUSTRY DOCUMENTS

ATTENTION:

BEFORE YOU READ THE ABSTRACT OR CHAPTER ONE OF THE PROJECT TOPIC BELOW, PLEASE READ THE INFORMATION BELOW.THANK YOU!

INFORMATION:

YOU CAN GET THE COMPLETE PROJECT OF THE TOPIC BELOW. THE FULL PROJECT COSTS N5,000 ONLY. THE FULL INFORMATION ON HOW TO PAY AND GET THE COMPLETE PROJECT IS AT THE BOTTOM OF THIS PAGE. OR YOU CAN CALL: 08068231953, 08168759420

WHATSAPP US ON 08137701720

NARRATIVE REVIEW: THE PROMOTION OF GABAPENTIN: AN ANALYSIS OF INTERNAL INDUSTRY DOCUMENTS

Key Summary Points Industry promoted gabapentin for on- and off-label uses as part of a comprehensive marketing plan. Frequent prescribers of anticonvulsant agents, opinion leaders, and local champions of gabapentin were specially targeted for promotion. Gabapentin was promoted by using education and research, activities not typically recognized as promotional. Independent continuing medical education, peer-to-peer selling by physician speakers, industry-funded studies, and publications in the medical literature were used to advance marketing goals for the drug. Recent litigation and congressional inquiry have provided access to pharmaceutical industry documents that shed light on the marketing strategies used to promote drugs (1). One example is the case of gabapentin (Neurontin, Pfizer, Inc., New York, New York). First approved by the U.S. Food and Drug Administration (FDA) in late 1993 for adjunctive treatment of partial complex seizures, by the mid- and late 1990s gabapentin was being widely used for the off-label treatment of pain syndromes and psychiatric conditions (Figure 1) (24). Although gabapentin was later approved for the treatment of postherpetic neuralgia, in 2004 the Pfizer subsidiary Warner-Lambert settled litigation and admitted guilt in connection to charges that during the 1990s it violated federal regulations by promoting the drug for pain, psychiatric conditions, migraine, and other unapproved uses (Table 1) (57). Figure 1. Prescriptions for gabapentin, by diagnostic category. Estimates of diagnosis-linked prescribing provided by Pfizer, Inc. (24). Each diagnosis was assigned to a diagnostic category by the authors. *Adjunctive treatment of epilepsy in adults older than age 12 years was the only U.S. Food and Drug Administrationapproved use of gabapentin during the time period shown. Table 1. Timeline* Although news articles have described some practices used to market gabapentin (8, 9), to our knowledge there has been little systematic investigation of the overall structure of promotion for this drug. In this paper, we use public documents obtained through litigation to describe how marketing strategies and tactics for gabapentin were developed and used in the mid- and late 1990s. First, we describe the overall organization of marketing efforts, and how certain groups of physicians were targeted as recipients of and vehicles for promotion. Next, we describe specific marketing activities, focusing on how education, research, and other activities not typically considered promotional were used to achieve marketing goals. Methods We reviewed approximately 8000 pages of publicly available documents regarding the case of United States of America ex. rel David Franklin vs. Pfizer, Inc., and Parke-Davis, Division of Warner-Lambert Company. Among documents pertinent to this research, two thirds were created between 1994 and 1998 and comprised a mix of internal correspondence and reports; programs, presentations, and transcripts from activities sponsored by Parke-Davis; and correspondence between the drug company and outside vendors and physicians. The remaining pertinent documents included excerpted depositions of Parke-Davis employees and court documents. These documents are now available in a digital archive at dida.library.ucsf.edu. We reviewed documents using the principles of grounded theory, an inductive approach in which source material was used to generate ideas rather than to test a preestablished hypothesis (10). All documents underwent primary review by 1 author, with selected review by the coauthors. First, we cataloged marketing techniques and identified broad themes about marketing strategy for gabapentin. Next, we discussed initial findings and re-reviewed pertinent documents in an iterative process to arrive at the final description and interpretation of marketing techniques and themes. To better understand the role of individuals and organizations discussed in the documents, we obtained supplemental information from the court and through Internet and PubMed searches. Most data on payments to physicians and organizations were obtained from a payment register compiled by the plaintiff’s attorneys from documents supplied by Parke-Davis (4, 11) and augmented with additional information provided to us by those attorneys (for additional detail on analyses of the payment register, see Appendix 1). We also used budget planning documents from 1998 and other years to estimate expenditures for different forms of marketing (1214). During the period under review, gabapentin was approved only for the adjunctive treatment of partial seizures in persons older than 12 years of age at dosages up to 1800 mg/d. Thus, for this review, we considered any other indication to be unapproved. In quotations of documents, items in brackets are our addition and represent our best interpretation of abbreviations, phrases, and other data. This research was approved by the Research and Development Committee of the San Francisco Veterans Affairs Medical Center and the Committee on Human Research at the University of California, San Francisco. The aforementioned archive paid the cost of obtaining and photocopying documents used in this research. No outside source had a role in the mechanisms of document review, presentation of results, or decision to submit the manuscript for publication. Data Synthesis Marketing Strategy Each year, corporate leadership established broad goals (strategies) for the marketing of gabapentin. Specific programs (tactics) were then designed to achieve that year’s strategic goals (15, 16). For example, planning documents for 1998 show a projected $40 million advertising and promotion budget for gabapentin organized under 4 topline strategies, further divided into a variety of tactical categories (Table 2) (12, 13). Professional education accounted for half to two thirds of the projected promotional budgets for 1996 through 1998 (1214). Table 2. Draft Advertising and Promotion Budget for Gabapentin for 1998, by Strategy and Tactical Category* Parke-Davis identified several groups of physicians for targeted marketing. One such group was physicians who frequently prescribed anticonvulsant agents, categorized by the dollar value of anticonvulsant prescriptions they had the potential to generate (>$300000 for the highest tier of prescribers) (14, 15, 1723). Another key group was physicians who had the potential to influence gabapentin use among their colleagues. This included local champions of the drug, who were recruited and trained to serve as speakers in peer-to-peer selling programs (19, 2426), which were noted to be one of the most effective ways to communicate our message (19). Another important segment was thought leaders, key influencers, and movers and shakers, influential physicians identified in part by their affiliation with major academic medical centers (12, 13, 1820, 24, 2628). For example, in 2 documents Parke-Davis identified 40 potential thought leaders in the northeastern United States, including 26 current or future department chairs, vice chairs, and directors of academic clinical programs or divisions (24, 27). Of these 40 leaders, 35 participated in at least 1 Parke-Davissponsored activity, including 14 who requested or were allocated $10250 to $158250 in honoraria, research grants, or educational grants between 1993 and 1997 (11). Parke-Davis also targeted residents; planning documents for the 1998 advertising and promotion budget show allocations of $195000 to $330000 for resident programs, a video case series, and a CNS [central nervous system] residents course (13). As described in one report, efforts with residents could be used to influence physicians from the bottom up and to solidify Parke-Davis’ role in the resident’s mind as he/she evolves into a practicing physician (24). Tactics Continuing Medical Education Medical education drives this market!! noted the author of a Parke-Davis business plan (29). Accordingly, educational activities were used to implement strategic goals for gabapentin (12, 3032), often through events at which physician speakers could communicate messages about gabapentin directly to their colleagues. Teleconferences linking paid physician moderators with small groups of physicians were a method for reaching prescribers. Although these teleconferences were titled as educational events (33), an internal memo about 1 set of 143 teleconferences on epilepsy management noted that the key goal of the teleconferences was to increase Neurontin new prescriptions by convincing non-prescribers to begin prescribing and current prescribers to increase their new prescription behavior (34). In some cases, Parke-Davis helped establish the agenda and was able to surreptitiously monitor teleconferences in progress. In 1 set of 39 calls organized through a medical education and communications company to discuss unapproved uses of gabapentin, an agenda was prepared for physician moderators directing them to discuss such topics as how Neurontin evolved into a first line therapy option in your practice (35, 36). In another series of psychiatry teleconferences organized through a third-party vendor, senior Parke-Davis employees were invited to participate but told to instruct the teleconference operator that you should be in LISTEN ONLY mode and your name should NOT be announced during introductions (capital letters in original) (37). Documents suggest that in some cases moderators were paid $250 to $500 per call and had other financial ties to Parke-Davis (11).

HOW TO RECEIVE PROJECT MATERIAL(S)

After paying the appropriate amount (#5,000) into our bank Account below, send the following information to

08068231953 or 08168759420

(1) Your project topics

(2) Email Address

(3) Payment Name

(4) Teller Number

We will send your material(s) after we receive bank alert

BANK ACCOUNTS

Account Name: AMUTAH DANIEL CHUKWUDI

Account Number: 0046579864

Bank: GTBank.