Biomedical Engineering Reference
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Schering-Plough Corporation who paid $435 million dollars as part of their plea
agreement to settle charges for marketing drugs. In fact, six out of the top ten phar-
maceutical companies 6 in 2007 have faced recent or current litigation due to their
marketing tactics.
The case we selected, United States of America ex. rel David Franklin vs. Pfi zer
Inc, and Parke-Davis, Division of Warner-Lambert Company, involved marketing
practices related to Neurontin ® (chemically known as gabapentin) which was mar-
keted in over 100 countries, used by over 12 million patients and was generating
revenue of over $2.7 billion. The FDA initially approved gabapentin in 1993 for
adjunctive treatment of partial complex seizures in adults older than 12 years in age
and for dosages not exceeding 1,800 mg/day. However, by the mid-nineties, gaba-
pentin experienced its highest growth in off-label treatment of pain syndromes (e.g.,
neuropathic pain, migraine) and psychiatric disorders (e.g., social phobia, bipolar
disorders). Parke-Davis admitted that it used marketing and promotion strategies for
unapproved, off-label uses. Under current United States law, it is neither illegal nor
unethical for physicians to prescribe a drug for purposes unrelated to its FDA
approved uses. Physicians are privileged by law to prescribe a drug for treatments
for which they believe there is suffi cient evidence of effi cacy based on scientifi c
evidence in peer reviewed journals and expert recommendations. Pharmaceutical
companies are legally restrained from directly marketing and promoting a drug for
off-label uses. As such, the marketing practices used are not illegal per se. They are
illegal only if they are used to directly promote off-label uses.
Data characteristics and analysis. The court documents were obtained directly
from the attorneys, and supplemented with archived data from a website of all per-
taining documents housed at the University of California, San Francisco ( http://
dida.library.ucsf.edu ) . The documents included internal correspondence, details of
sponsored activities and programs, exchanges between drug companies and physi-
cians, and sworn depositions from key individuals. In analyzing these documents,
we adopted an inductive approach with multiple coders. Two teams, each involving
a lead researcher and a student, were constituted. The fi rst team initially combed the
materials to extract the key strategies and associated networks that had a direct or
indirect bearing on the company's relationships with physicians. The second team
then independently extracted the key strategies and networks, and met with the fi rst
team to resolve differences and integrate extracted strategies. Further, to ensure that
the inductively derived descriptive patterns are not idiosyncratic to the gabapentin
case but refl ect broader industry practices, we supplemented this analysis with
review of secondary materials including: (1) media reports and articles (e.g.,
Business Week , The Wall Street Journal, CBS News ), (2) industry (e.g., PhRMA)
6 The top 10 pharmaceuticals based on revenues ( http://www.contractpharma.com/articles/2007/07/
2007-top-20-pharmaceutical-companies-report ) are: Pfi zer, GlaxoSmithKline, Sanofi -Aventis,
AstraZeneca, Novartis, Merck, Johnson & Johnson, Roche, Wyeth, and Eli Lilly and Co. The
companies that were taken to trial and successfully convicted are Pfi zer, AstraZeneca, Merck,
Johnson & Johnson, Wyeth, and Eli Lilly and Co.
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