2009-05-07
The Institute of Medicine (IOM) has released a pre-publication copy of its report “Conflict of Interest in Medical Research, Education, and Practice”
that calls for both legislation and “voluntary measures” to improve the
disclosure of financial ties between the medical community and
industry. Former ASH president Dr. Kenneth Kaushansky testified
before the IOM Committee that developed this report on behalf of ASH in
May of 2008, outlining ASH’s principles and policies on managing
conflicts of interest. ASH is pleased that it is already in compliance
with IOM’s recommendations and does not anticipate any immediate
changes to its policies.
The report calls for Congress to pass legislation requiring
companies to provide full disclosure of payments made to researchers,
academic medical centers, professional societies, patient advocacy
groups, and any other institutions involved in
health-care/medicine. This recommendation is consistent with proposed
legislation, The Physician Payment Sunshine Act,
introduced in January 2009 by Senator Charles Grassley (R-IA). The
bill, if passed, would require drug and device companies to disclose
all payments to physicians over $100 in any calendar year beginning in
2010, with that information available to the public beginning in 2011.
The IOM Committee recommends physicians, researchers, and medical
school faculty to voluntarily abstain from accepting “gifts of any
amount,” including meals, from the industry, and refuse to present or
publish any material prepared or ghostwritten by the industry.
The report also calls for an end of industry-funded CME courses and
practice guidelines, calling the current funding mechanism
“unacceptable.” The Committee stopped short of a complete ban on
industry funding, recognizing the potential unintended harm from such a
ban. It calls for research into and development of alternative funding
mechanisms. The Committee also has some specific recommendations on
development of practice guidelines, calling for groups to reject all
direct industry funds for clinical guideline development and generally
exclude panel members with conflicts of interest. The Committee
recognizes that it may be impossible to obtain needed expertise without
some existing conflicts and recommended measures to limit the
likelihood of undue influence of panel members with existing conflicts
if interest (e.g., allowing for only minority of panel members with a
disclosed conflict, but not the Chair, and precluding such members from
voting on topics in which they have a financial interest).
ASH is dedicated to advancing the specialty of hematology. To
accomplish this mission, the Society provides support for a variety of
activities in the areas of research, education, training, and advocacy.
The integrity of ASH and the activities it undertakes depends on the
avoidance of conflicts of interest, or even the appearance of
conflicts, by the individuals involved with those activities.
ASH has adopted eight principles that underscore its commitment to
managing real/perceived conflicts of interest, as well as eight
policies that lay out specific ways in which the Society safeguards the
integrity of the programs and activities in which its membership is
engaged. ASH’s Conflict-of-Interest policy is available.
ASH considers financial relationships of relevance to be those that
have occurred in the past 12 months for the volunteer, partner, or
spouse including: employment, consultancy, equity, research funding,
honoraria, patents and royalties, speakers bureau involvement, advisory
committee membership, board of directors membership, expert testimony,
and financial support for the costs of travel to the ASH annual meeting.
ASH agrees generally with the definitions of financial interests in
research outlined by the Association of American Medical Colleges
(AAMC). Specifically, ASH agrees with the AAMC that the following do
not represent significant financial interests: (a) Interests in
publicly traded diversified mutual funds and (b) salary and other
payments for services from the members institution. However, because
corporate arrangements vary substantially from institution to
institution and because institutional and investigator interest in a
trial may be influenced by indirect costs provided to institutions
conducting corporate sponsored clinical trials, ASH does not agree with
the AAMC that “payments to the institution, or via the institution to
the individual, that are directly related to reasonable costs incurred
in the conduct of research as specified in the research agreement(s)
between the sponsor and the institution,” can always be excluded as
significant financial interests.
ASH’s policies concerning the management of conflicts of interest
were updated in February 2008 and involve all aspects of the Society –
from committee meetings to annual meeting organization and speakers,
its journal and other publications, and the development of clinical
guidelines. As an ACCME-approved provider, ASH fully complies with the
new continuing medical education rules regarding meeting program design
and speaker disclosure.
In addition, ASH has separated corporate sponsored symposia from the
official ASH annual meeting and now prohibits anyone who participates
in a corporate program from being invited as an ASH speaker in the same
year. ASH has put enforcement mechanisms in place to ensure that oral
and poster presentations fully disclose conflicts of interest and has
increased the number of hematologists who formally review educational
and special speaker presentations – as well as corporate sponsored
symposia – to report bias or the appearance thereof. A centralized
system tracks speakers who fail to comply with conflict-of-interest
requirements; the system is being expanded to allow Web-based
management of the process.
ASH also changed its policies to prohibit individuals with recent
relevant financial conflicts from serving as a member of a clinical
guideline writing committee. ASH is pleased that the IOM agreed with
ASH’s concerns about the feasibility of creating guidelines with these
limits, as reflected in the report.
Questions and comments regarding the ASH conflict-of-interest
principles and policies can be directed to the ASH Chief Operating
Officer, Matthew Gertzog, at mgertzog@hematology.org.
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