NcXHF

INDUSTRY AND ONCOLOGY
KEY POINTS
Financial relationships between industry and oncology
physicians are common.
Conflict of interest policies historically have relied on
disclosure to maintain transparency, but little is known
about the effect and influence of these relationships on
research conduct, outcomes, and dissemination.
The goal of the Sunshine Act is to enhance transparency
about these relationships, but its implementation has
raised multiple concerns.
Direct-to-consumer advertising has a substantial effect on
medical practice and influences drug utilization.
Partnerships between pharmaceutical companies and
oncology researchers are essential for the development of
new treatments and innovations.
tion and academic advancement may lead to unethical behavior.
The presence of fınancial interests might influence
decision making and research conduct. These relationships
have the potential to compromise research integrity, create
scientifıc bias for researchers, and lead to public and patient
mistrust. Profıt motives by the manufacturer, shared with the
clinical researcher through FCOI, could potentially lead to
poor or inaccurate science and ultimately harm the public
interest. 10
To date, management of FCOI has been based on rules or
policies mandating disclosure of industry relationships.
These policies aim to increase transparency to engender public
trust for the medical research community, and by acknowledging
the presence of these relationships, they ideally
lead to an open dialogue between the public and oncologists.
As policies call for wider disclosure of potential FCOI, and at
times prohibition of specifıc fınancial relationships, there is
both a need and an opportunity to better understand the
prevalence of investigator and research relationships with industry
and the effect of these relationships on research and
dissemination of results. 6,7 However, despite the widespread
implementation of conflicts of interest policies in academic
centers, federal agencies, and professional medical societies,
little is known about how FCOI influences research conduct,
outcomes, and dissemination. 11-13
These conflict of interest policies also do not address nonfınancial
conflicts of interest that address professional or
ideologic issues, such as academic advancement, promotion,
and publication. The desire for academic advancement could
lead academic cancer researchers to seek out relationships
with industry that has proprietary technology in an effort to
participate in more important and influential research. These
nonfınancial conflicts have not been as well studied. Greater
examination of the benefıts and risks of these relationships
should be paid.
Currently, most FCOI policies rely on disclosure alone to
address conflicts of interest. In part because of the diffıculty
of relying on disclosure alone to address the problematic consequences
of physician–industry ties and associated conflicts
of interest, proposals have emerged for academic medical
centers to ban all gifts, meals, payment for travel to or time at
meetings, and payment for participation in online continuing
medical education (CME) from industry to physicians. 14
These concerns have also led to the consideration of creative
ways to introduce more distance into relationships between
physicians and industry, including provision of vouchers
rather than samples for low-income patients, elimination of
direct funding of CME, and limitation of grants for general
support of research to institutions rather than individual
physician investigators. Unfortunately, some conflicts of interest
may be particularly hard to eradicate, including situations
where physicians have an ownership interest in medical
equipment being advertised. Nevertheless, it is clear that at
least for relationships with manufacturers of drugs, tests, and
technologies used in the management of patients with cancer,
approaches that minimize the direct relationship and try
to maintain some distance between individual physicians
and industry merit consideration.
Given the complexity of these relationships with industry
that lead to positive and negative consequences for the oncology
provider and researcher, the oncology community
must rationally understand these issues. It may be within the
public interest to foster, rather than discourage, some relationships.
Instead, there may be a need for greater scrutiny on
the degree to which FCOI are managed or prohibited and the
effect of such policies over time.
SUNSHINE ACT
The direct goal of the Sunshine Act is to enhance transparency
about relationships between health care providers and
purveyors of health care products and services. When the
original bill was fırst introduced in 2007 (S.2029), one of the
cosponsors, Senator Claire McCaskill, stated, “I believe that
by bringing light to these relationships, this legislation will go
far in reducing big drug companies’ influence on the business
of medicine.” Another cosponsor, Senator Charles Schumer,
stated, “This bill will shine a much needed ray of sunlight on
a situation that contributes to the exorbitant cost of health
care. Patients have the right to know if drug and device
makers are attempting to influence physician prescribing
decisions with gifts, consultations, and travel.” Thus, the
Sunshine Act requires companies to submit information regarding
their fınancial relationships with providers to the
U.S. Department of Health and Human Services (HHS) and for
such information to be publicly available. This led to the creation
of a database, Open Payments, so that patients can theoretically
identify providers whose professional judgment may be
clouded by personal fınancial interests, enabling informed patients
to question their physicians’ prescribing decisions. Furthermore,
particularly concerned patients could simply choose
physicians who had no fınancial relationships, based on a search
of the Open Payments database.
It is too soon to assess whether or not patients are utilizing
the Open Payments database in the manner Congress in-
asco.org/edbook | 2015 ASCO EDUCATIONAL BOOK 131