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.
Our findings show that off-label marketing practices have a broad reach. Similar
behaviors and strategies were linked to manufacturers of varying sizes across drugs
in virtually all therapeutic classes; they extended to many aspects of the health
care system; they affected a multitude of players (prescribers, pharmacies, disease
advocacy groups, CME organizations, consumers); and were pursued through virtually
every facet of physician-industry relationships (paid consultancies, preceptorships,
and collaboration in clinical trials and research publications). The alleged tactics
in our analytic sample ranged from subtly encouraging physicians to ask for
information about off-label uses to providing strong financial rewards for
encouraging off-label uses; they also included targeting multiple links in the
prescription production chain, from company scientists and sales representatives to
prescribers.
Some of the practices we identified have been highlighted in anecdotal reports and
are relatively well known. Others have received little or no attention, such as
pharmaceutical marketing representatives working directly with physicians and their
office managers to circumvent reimbursement restrictions set by government payers
and other insurers. Nearly a quarter of the whistleblowers alleged that
pharmaceutical sales representatives were given access to patients'
confidential medical records at physicians' offices for the purposes of
trolling for prospective targets for illegal direct-to-consumer promotion of
off-label uses. Despite the remarkable prevalence of this practice among the
complaints we analyzed, media coverage has tended to center on other, more
institutionally focused aspects of fraud.
New regulatory strategies, both public and private, aimed in part at preventing
off-label marketing, have proliferated in recent years. Medical journals have
changed their authorship standards to foil ghostwriting
[49]; following the example of
several states, the federal health care reform legislation requires disclosure of
pharmaceutical industry payments to physicians
[50]; the leading pharmaceutical
manufacturers' association, PhRMA, has adopted a Code of Ethics that prohibits
certain types of gifts
[51]; and a handful of academic medical centers have
restricted or prohibited visits by pharmaceutical sales representatives
[52]. Our findings
support the need for these measures to combat gifts to physicians, which we
identified as the single most prevalent modality of off-label promotion reported by
whistleblowers.
However, our results also suggest that additional steps will likely be necessary to
curb off-label marketing. For example, interventions seeking to insulate physician
education from industry influence have largely been limited to programs in which the
manufacturer controls the content, but the reports in this study suggest that even
so-called “unrestricted” educational grants from industry may be
deployed to effect off-label marketing. A better policy solution would be fully
independent programs of continuing medical education, an approach that has received
limited support in a few states and has been proposed (but not enacted) in US
Congress. Another potential solution is a central repository, independent from any
physician or health care organization, where manufacturers can donate money that is
then distributed for educational purposes.
Some experts have suggested that fraudulent off-label marketing might be prevented
through more substantial fines for manufacturers under investigation or other
penalties for company managers
[53]. Criminal prosecutions of executives are rare
[54], but the DOJ
has signaled increasing interest in using this approach
[53]. While seeking to fortify
deterrence through such tactics might address some behaviors, our findings suggest
that some common off-label marketing practices may be difficult to control through
external regulatory approaches because of their deep-seated nature. Whistleblowers
in most of the cases we reviewed reported that private conversations between sales
representatives and prescribers were a leading strategy for off-label promotion. The
opportunity to prompt and answer physicians' questions about off-label uses,
address their individual concerns, and provide a digest of empirical evidence that
can be slanted as needed likely makes these conversations a particularly effective
form of marketing. The fact that so many of the communications are oral and take
place in private offices makes them very difficult for regulators to monitor and
sanction. It is impossible to conceive of how anyone other than a company insider or
a physician could bring many of these marketing practices to light (indeed, this
underlines the distinctive strength of our data source). The move by a few prominent
academic medical centers to ban sales representatives from the premises is a bold
and powerful one, but it has not, as yet, been followed by many hospitals or
physician practices.
Changes in the PhRMA Code are a positive sign that the industry is responsive to
public concerns about inappropriate marketing practices. In some news reports,
manufacturers have described new corporate cultures that avowedly reject the illegal
tactics described in the whistleblower complaints
[55]. However, in many of the cases
we studied, manufacturers were reported to demonstrate awareness of existing
regulations and engage in strategic behaviors to work around them (e.g., by giving
employees lectures about the regulatory environment that were understood to be a
smokescreen) or to mask their violations of the law (e.g., by encouraging employees
to not enter off-label marketing calls in their logs).
Our approach has limitations. First, although the DOJ conducted thorough
investigations of each complaint in the study sample, the settled cases concluded
without a full trial, which would have included formal fact-finding by a judge or
jury. Thus, some allegations may be false and, for nearly all complaints, internal
company documents that might have corroborated the complainants' specific
reports remained confidential. Second, our analyses were conducted mainly at the
complaint level, but nine of the 18 cases involved more than one complaint (the DOJ
permits multiple complaints when each brings new information to bear on the case);
the clustering of complaints in some cases may have inflated the reported prevalence
of certain behaviors. Third, most whistleblowers were US-based sales representatives
with a particular field of vision in relation to their companies' off-label
marketing practices. It is possible that other behaviors and strategies exist that
the whistleblower did not observe and the government investigations did bring to
light. Our reliance on the text of the complaints means that we would have missed
these. Finally, the complaints were composed to support claims of fraud under
certain specific legislation, including the False Claims Act.
Conclusion
Off-label marketing has been ubiquitous in the health care system and features
some behaviors and strategies that may be resistant to external regulatory
approaches. Our findings suggest that no regulatory strategy will be complete
and effective without physicians themselves serving as a bulwark against
off-label promotion. Aside from sales representatives and other company
insiders, who play important roles as whistleblowers, physicians are alone in
having a full view of many of the most insidious forms of illegal marketing
outlined in the complaints we reviewed. As physicians' understanding of
these practices and the consequences of inappropriate off-label promotion for
public health evolves, so may their enthusiasm for shutting them down.
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