http://jama.ama-assn.org/issues/v284n17/ffull/jed00080.html#r18
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This issue of THE JOURNAL
contains a cluster of articles that address students', residents', and
faculty members' conflicts of interest with pharmaceutical and other
companies that financially sponsor teaching and research. Why is this
important? University-based educators and researchers, as well as private
practitioners, are in frequent contact with representatives from for-profit
companies that provide "gifts" and financial support for teaching
and research. The enticement begins very early in a physician's career: for
my classmates and me, it started with black bags. Dr Kassirer's colleague1 is not
alone in remembering which pharmaceutical company provided them. The timing
of presenting the black bags early in our first year was wonderfully
strategic, as was the inscription of our names on each. I must admit I was
very happy to finally have a real symbol of the medical profession after so
many hours of what seemed like year 5 of college. It took me a few days to
come back to reality and store the bag in my closet. I'm not sure what
happened to it, but I never carried it after that first day. On the other
hand, at that time I did not have the courage to publicly state my unease
with the unearned "gift." Subsequently, offers came
for "free" lunches, dinners, and tickets to various events followed
by offers to serve as an "expert" with the usual lineup of speaking
engagements and serving on advisory panels and boards, for an "honorarium"
of course. There should be little question about the expected effects of
accepting free food, tickets, and even black bags. It has been shown that
clinicians' decisions are affected by their interactions with pharmaceutical
companies.2
This is no revelation; why else would anyone provide these "free"
gifts except ultimately to assist in the selling of a product? The public is
well aware of this problem, and it has become a favorite subject of recent
newspaper articles.3, 4 The issue of receiving
reimbursement for providing time and expertise, as a speaker (teacher),
advisor, or researcher, is more complex. Persons asked to provide expertise
as teachers or researchers generally are selected from a pool of those best
prepared and experienced in the field. Who is better equipped to teach or
perform the studies, and why shouldn't they be rewarded for their work? The
problem lies in the conflict of interest that results from these
relationships. It is vitally important to understand that a conflict of
interest does not necessarily result in an outcome different than the result
would have been without such conflict. The potential for differing results is
the problem at hand. Balance must be
maintained between the need for research projects to be reasonably funded and
performed by the best possible investigators and the relative paucity of
public funds for clinical research. In 1999, the National Institutes of
Health (NIH) provided $17.8 billion for research, and the major proportion
was expended for basic research; the top 10 pharmaceutical companies spent
$22.7 billion, primarily on clinical research (Hamilton Moses III, MD, The
Boston Consulting Group, personal communication, 2000). The likelihood that a
clinical investigator would be funded by private vs public funds is
substantial. Furthermore, a recent study by USA Today revealed that
more than half of the advisors to the Food and Drug Administration (FDA) have
financial relationships with pharmaceutical companies that have an interest
in FDA decisions.5 When an investigator has
a financial interest in or funding by a company with activities related to
his or her research, the research is lower in quality,6, 7 more
likely to favor the sponsor's product,8-11 less
likely to be published,12, 13 and
more likely to have delayed publication.14
Institutional safeguards can substantially mitigate the negative effects of
funding from companies with a vested interest in the results. In this issue of THE
JOURNAL, Boyd and Bero15
provide a case study of the University of California, San Francisco faculty's
financial relationships with industry. By 1999, 225 researchers (almost 8% of
total faculty investigators) had been involved in 488 disclosures. One can
only postulate the results from other institutions that accept private
funding for research, and it is an unusual institution that does not do so.
Therefore, all research universities should emulate Boyd and Bero's study to
determine the extent of their faculty members' involvement with industry and
to institute proper oversight. Also in this issue, Cho
et al16
report on the content of conflict of interest policies at 89 biomedical
research institutions receiving the most NIH funding in 1998. Their results
show that while there appears to be a lack of specificity about the exact
nature of the relationships of their faculties with industry, the vast
majority (89%) at least had mechanisms for disclosure to the institution.
However, only 19% had specific prohibitions or limitations of activities
related to research or teaching, and 38% had institutional committees to
review conflicts of interest. As the amount and proportion of funding from
private corporations for research increase, it is vital that all institutions
that accept these funds develop methods for disclosure and oversight. In a Commentary, Korn17 addresses
the complexities of ensuring that academic medical centers preserve the
confidence and support of the public and government agencies while
maintaining the funding necessary to remain on the cutting edge of research.
He discusses how the inevitable conflict of interest issues must be managed
by academic centers. Finally, Kahn and
colleagues18
illustrate what can happen when disagreement occurs between the funding
sponsor and the investigators when the sponsor has a proprietary interest in
the findings. The investigators report that some data were not made available
to them by the sponsor. The integrity of the research process rests on a
sound study design and the disclosure of all pertinent results, whether
positive or negative, based on analysis of all necessary data. In this case
the data set is incomplete, but the investigators, peer reviewers, and
editors believe it to be of sufficient merit to warrant the conclusions. Our
decision to publish this study is based on the belief that the integrity of
the research process must be protected and preserved. The authors have
provided the best research possible under the circumstances. If further data
are or become available that refute or alter the conclusion of this study, I
welcome submission of such material. Science is a dynamic and ongoing
process, and we must allow it to continue. Unlike the majority of,
if not all, for-profit businesses in our capitalistic society, managed health
care corporations have not provided funding for research and development
(education). This is true despite the advantages they derive from the
research and education provided primarily by academic medical centers.
Furthermore, there is little chance that sufficient funding for important
clinical research, especially expensive clinical trials, will be forthcoming
from sources other than sponsors with a vested interest in the results. Those
best prepared and experienced to carry out such complex studies generally are
faculty in academic institutions. Therefore, it is vitally important that
these institutions develop conflict of interest policies, have oversight
mechanisms in place, and continuously monitor the relationships of faculty
with sponsoring companies and agencies. Without these policies
and procedures, the academic institutions where most clinical research is
based and their faculty members who perform the research are in grave danger
of losing the support and respect of the public. Without this support and
respect, trust in new medical discoveries and their applications will not be
forthcoming. Without trust, medical research is doomed.
REFERENCES
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106/L
CD4 cell counts: a randomized controlled trial.
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GENERAL INFORMATION PURPOSES ONLY AND IS NOT TO BE CONSTRUED AS REFLECTING THE
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