Date Published: April 5, 2011
Publisher: Public Library of Science
Author(s): Aaron S. Kesselheim, Michelle M. Mello, David M. Studdert, Joseph S. Ross
Abstract: Aaron Kesselheim and colleagues analyzed unsealed whistleblower complaints
against pharmaceutical companies filed in US federal fraud cases that contained
allegations of off-label marketing, and develop a taxonomy of the various
Partial Text: In the US, a setting dominated by aggressive advertising of prescription drugs to
patients and physicians, off-label marketing has been a controversial subject area.
Physicians are permitted to prescribe drugs “off label”—that is,
for purposes and patient populations outside of those formally approved by the US
Food and Drug Administration (FDA). However, the FDA prohibits pharmaceutical
companies from engaging in direct promotion of those unapproved uses . The
rationale is that such marketing can lead to widespread uses of a drug that are not
based on evidence of efficacy and safety, expose patients to uncertain benefits and
the prospect of adverse effects, and undermine incentives for manufacturers to
conduct clinical trials necessary to achieve FDA approval for new uses –.
A total of 41 complaints arose from 55 whistleblowers (Table 1). At the time of the alleged fraud, the
whistleblowers worked as pharmaceutical sales representatives (39/55, 71%),
sales or accounting managers (11/55, 20%), and unaffiliated physicians (5/55,
9%). The cases were brought against 18 manufacturers, including both large
companies with diverse drug portfolios (e.g., Pfizer, Eli Lilly) and smaller
companies selling a relatively narrow range of products (e.g., Orphan Medical,
Medicis). At the time of analysis, settlements had occurred in 16 of the 18 cases
and totaled US$7.9 billion in damages.
Through a comprehensive review of whistleblower complaints, to our knowledge the
first of its kind, we found descriptions of a range of marketing practices related
to off-label promotion of prescription drugs. All of the strategies and behaviors we
outlined were alleged by whistleblowers with special knowledge of company practices,
although none of the complaints was subject to full trial and evaluation by a judge
or jury. The study provides a basic empirical snapshot of the extent to which each
of these strategies and practices have been employed, at least among cases exposed
in qui tam litigation.