ARVO has a financial disclosure policy that has been in place for
several years. This policy is presented in detail in the author
instructions for Investigative Ophthalmology and Visual
Science (see www.arvo.org/arvo/commerci) and, for presentations at
the annual meeting, in the abstract submission forms. Simply stated,
the policy asks authors to disclose whether they have any financial
interest in the research presented or in that of a competitor. To quote
from the policy: “The ARVO Board of Trustees believes that financial
interests should not restrict presentation or publication but that the
audience should be aware that such interests exist.”
ARVO is not alone in its concern about financial disclosure. In 1991,
Hillman et al.
1 discussed the types of biases that may
occur because of the behavior of the scientist/clinician, the
sponsoring firm, or both. They pointed out that bias is especially
possible in studies that have an economic impact and propose a standard
for improving the quality of economic analyses. In the past decade,
scientists in fields as diverse as neurology, nutrition, psychiatry,
internal medicine, epidemiology, and veterinary science have
highlighted financial disclosure issues in their
publications.
2 3 4 5 6 7 8 There is even a proposal in the journal
Neurology that sets a finite financial limit, beyond which
individuals with substantial investments recuse themselves from
reviewing manuscripts.
9
What constitutes a “financial interest”? If you have received any
compensation (funds, services, or goods) beyond a meal, then you have a
financial interest. If you have the future possibility of financial
gain through patent ownership, etc., then you have a financial
interest. ARVO asks for the nature (although not the magnitude) of this
financial interest to be stated.
There are some obvious examples of having a “financial interest” in
your ARVO presentation or
IOVS manuscript. For example:
-
Did a pharmaceutical firm give you a grant (restricted or
unrestricted) to conduct the studies you are presenting?
-
Did a firm provide biostatistical or other such support for data
analysis?
-
Did you conduct this research as a contractor to a firm?
-
Do you own a patent for, or are you an inventor of, the product
described?
-
Do you own stock in a firm that owns the product or process you are
describing?
-
Do you have stock options in a competitor’s firm?
There are also some less obvious examples of having a financial
interest:
-
Did a firm whose product, device, or process you evaluated pay your
travel expenses to talk about the product, device, or process at a
meeting?
-
Did a firm handle logistics and expenses for a practical course you
taught on the product, device, or process?
As listed in ARVO’s Commercial Relationships Policy statement,
there are different codes for each of these types of financial
relationships. The abbreviation “P,” for example, stands for the“
Product” category where there is a financial interest in the“
equipment, process, or product presented.” Likewise, there are
categories for Investor, Employee, or Consultant. Subcategories further
define the type of compensation or support received. This use of codes
differs from the American Academy of Ophthalmology (AAO) policy in
which any financial relationship beyond the “free lunch” is
combined into the same category of financial relationships.
The ARVO Commercial Relationships Policy also states, “Bias in
research presentation and publication can arise from various forms of
self-interest.” Thus, the “intellectual bias” that any scientists
may exhibit can also be of concern.
10 If you have spent
years of your scientific career in quest of a particular goal, and when
the results are obtained, there is no difference between your new
treatment and the standard of care, it may be difficult to give up the
theory. One could posit that there is no one with a greater proprietary
interest than the principal investigator presenting his or her data at
the ARVO meeting in May whose grant is up for renewal. It is probably
sufficient disclosure for such an investigator to cite the source of
funds in the appropriate section of the abstract form.
In the area of clinical trials, where outcomes are most immediately
felt in the financial marketplace, one could argue that double-masking
of clinical trials would minimize bias. Even here, intellectual bias
rather than sponsor-induced (financial) bias could skew the results. Of
course, such intellectual bias is not technically covered by the ARVO
guidelines but must be guarded against.
Yet another area of concern is that of “proprietary” methods.
Scientists are taught that the methods section of a paper should be
complete enough to allow another scientist to understand their work and
to be able to replicate it fully. In 1996, a scientist published a
clinical pharmacokinetic paper and footnoted a bioanalytical method.
Upon request of a colleague, the author refused to supply the method,
as it was “proprietary.” The Editor, who had assumed that details
would be made available to interested colleagues, then stated that he
would not accept such papers in the future.
11 The view of
ARVO and
IOVS is that, if one part of a scientific study is
not disclosable, then none of it can be presented. Again, this is not
technically covered by the ARVO guidelines but is certainly an area in
which full and open disclosure is demanded. There is the special case
where an investigator conducts an experiment using an instrument with a
proprietary technology (e.g., a visual field analyzer with a special
program). If the brand name and program name is cited, then I believe
that this would be adequate.
Finally, let me give you a personal example. As a consultant to
pharmaceutical firms, my compensation is typically provided as a fixed
hourly rate. I am happy when a regulatory filing for a client is
successful, and they can begin to market their product. If the firm
believes that I helped them in this regard, it will be more likely to
use me in the future and to recommend me to other firms. However, my
relationship is not a proprietary one since my compensation is not
directly related to the financial success of a product. If, on the
other hand, my compensation is in the form of stock or stock options,
and then, if the stock price increases at approval, my interest becomes
proprietary.
Once an author discloses a financial relationship, what happens?
ARVO’s Commercial Relationships Committee (CRC) believes that the
audience or reader will take this relationship into account as
appropriate in interpreting the research. For example, should the
stated conclusion of the author be that a new treatment for a disease
will instantly supplant all other treatments and the author is the
owner of the patent and receives a royalty from the manufacturer, the
reader might be circumspect. If there are two possible analyses of a
study, intent-to-treat and per-protocol, if the one favoring the new
therapy is overly highlighted, and again, if there is a proprietary
relationship for the authors, the reader might also be concerned.
However, in both of these extreme cases, self-reporting protects the
author from major criticism. For most properly self-reporting,
peer-reviewed research, it is the science and/or clinical outcome that
is of paramount importance; neither the scientist nor the sponsor
dictates the relevance and importance of the work.
12 Thus,
proper self-reporting can only enhance the credibility of the research
report and, to the discerning reader, should not be viewed as a
detriment or liability.
Therefore, ARVO scientists are asked to self-report financial
relationships in IOVS submissions. Likewise, for ARVO
meeting presentations, this is easily done by providing a short
statement on a poster or on a slide used during an oral presentation.
For occasions when a financial interest has not been disclosed, the CRC
serves as a site where a member can report an alleged act of
nondisclosure. Given the relative infrequence of these reports to date,
it has not been necessary to establish a formal policy on how to deal
with them – specifically, to take punitive measures against
nonreporters. It is incumbent on each scientist to be knowledgeable
about the Commercial Relationships Policy and to be forthright about
disclosure of financial and proprietary relationships regarding the
work being described. We can all agree that self-reporting among
colleagues is preferable to any type of centrally mandated system.
Financial Disclosure: The author serves as a consultant to
many firms developing and marketing ophthalmic pharmaceuticals. He has
stock or stock options in two firms, neither of which is mentioned in
this article.
Editorial Note: At the time of writing this article, Dr.
Novack was Chairman of the CRC. The present chair is Kenneth P. K.
Trevett, JD, COO and General Counsel of the Schepens Eye Research
Institute, Boston, Mass.