Medical Ethics in Utah:
February, 2007
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February's Literature Recommendation for your enjoyment from
our Medical Humanities Scholar, Tess Jones, is "Songs From the Black
Chair" by Charles Barber...."Songs From the Black Chair" is an unflinchingly realistic
and deeply compassionate essay by Charles Barber on his experiences as an
intake worker at the Bellevue Men's Shelter in New York. First published in the
Bellevue Literary Review, the essay was selected for reprint in Utne Magazine
and was selected for inclusion in Pushcart's Best of the Small Presses
2005
Managing Medical
Conflicts of Interest
Recent research on financial Conflict of
Interest (COI) in cancer research showed that 90% of patients expressed no
worry about financial ties that researchers or institutions might have with
drug companies-- although 40% still wanted disclosure of the oversight system
for researchers and 31% wanted disclosure of the researchers’ financial
interests.(1) If patients are not concerned with potential COI,
why ought others be concerned? Are patients uninformed? (77% in the above study
had heard nothing about financial ties related to clinical studies.) It may be
that the fiduciary relationship cancer patients have with their doctors,
combined with their intense hopefulness about surviving their disease, tends to
mitigate a sense of threat when financial conflicts of interest are present.
Jeff Botkin, MD, Associate VP for Research Integrity at the University of Utah
facilitated the January Evening Ethics discussion on “Conflict of Interest
for Physicians and Clinical Investigators” that probed the complex ethical
issues that arise in managing medical COI. This article explores these
concerns.
Incentives and potential bias:
avoiding the “tainted mind”
Management of COI takes on
greater importance as federal funds for research become limited and industry
funds become easier and more reliable sources of support. Today, the vast
majority of funding for research is private as barriers to industry research
disappear. Our free market system is based on the incentives that money
provides. Therefore, the claim that scientists are not influenced by money is
suspect. In academia, a scientist seeks truth, and wants to know “whether
X does Y”; but in industry, where profit is the goal, disincentive to
publish negative results is great. The system is indeed corruptible: when
industry sponsors research, more positive publications result. One needs only
cite published research on Vioxx.
When industry sponsors research, fear
arises that scientists may investigate and report on the most saleable product
instead of the “best” product, endangering patient safety and
compromising the integrity of the research process. Bias arises at an
unconscious level. If there is a “tainted state of mind” that comes
from being incentivized with money, what is a significant tie to business that
may distort clinical decisions? Is there an amount of money that can
“buy” a scientist, or is even the smallest gift—a pen or pad of
paper—enough to subconsciously influence a researcher and impair the
validity of a study? In health science research at the University of Utah, an
investigator is not thought to be potentially prejudiced by less than $10,000
per year. 98% of University of Utah researchers had no COI to report over this
amount. This amount would be quite sizeable compared to many other
professions.
Increasingly, doctors have discovered
that they can go into business and still practice medicine. Two historical
events have been instrumental in this change: 1) In 1980, the Bayh-Dole Act was
passed that allowed university labs to hold patents on their discoveries.
Universities crossed into the commercial world, licensing findings to companies
and sharing royalties with MDs and PhDs in academic labs who were responsible
for these discoveries. 2) When HMO’s began to reduce physician pay,
doctors turned to drug companies who were eager to hire them to give talks and
to consult to promote their products.
The Bayh-Dole act sought to speed up the
timeline from basic discovery to application. The Bayh-Dole act motivates by
allowing academics to start up businesses, get patents, and receive fame.
Academics can control which experiments they do and how they gather and
interpret data. These choices have enormous financial implications for
them. Especially in cutting edge research
where there is not enough duplication of evidence to provide validation, this
could be dangerous. Additionally, researchers with clear commercial interests
have been less likely to share in the public interest. Patenting genes was
cited as an example.
Some people are concerned that the
Bayh-Dole act has provided incentives for complicated device-based procedures
when less invasive, equally effective treatments, can be used.(2)
Conferences such as “Transcatheter Cardiovascular Therapeutics (TCT),
created, developed, and chaired by Martin Leon, MD, receives donations and fees
from medical device companies to stage and evaluate new products. Do these
types of conferences keep physicians up to date on new techniques--or feature
products for reasons other than their medical value?
Industry sponsored Research at the
University of Utah
Management of COI at the University of Utah focuses
on sponsored research and seeks to protect the integrity of the research
process, only. It does not, for example, monitor the integrity of the teaching
a researcher does. At the University of Utah, no COI has thwarted
research—all projects have been manageable.
Private funds differ from public funds in
that public grants go to the University, whereas private grants go to
individual researchers. Some express optimism that were industry money to go to
the University, the COI for individual researchers would drop out. But others
argue that because the goal of academia is knowledge but the goal of industry
is profit, the COI would merely be relocated to a University-wide level.
Several things were pointed out that affect COI: 1) some people are more
internally or externally motivated than others, 2) the institution’s sole
goal is not knowledge: politics reign everywhere, 3) Many things beside the
profit motive may “taint one’s state of mind” including
notoriety in career field, promotion possibilities, and publication records.
Management of sponsored research COI does not touch on these types of COI.
Ways of Managing COI
Various
ways of managing COI have included:(2)
- More stringent disclosure
requirements.
- Review of how COI are managed, i.e.
audits.
- Advisory panels with goals of
improving transparency and disclosures.
- Banning free lunches from industry,
recognizing that even small gifts might sway doctors prescribing habits.
- Prominent journal demands that authors
disclose potential conflicts, with some journals rejecting papers from those
who are closely tied to companies.
- 2005 expansion of Continuing Medical
Education guidelines for COI with monitoring begun in 2006.
Managing COI through disclosure is a
uniform but weak tool. It assumes that if the person disclosed to is aware of
the COI, then s/he can correct for potential bias. Current research shows that
we are not very good at making use of this information and correcting
appropriately for bias and that, in fact, disclosure may exacerbate problems by
giving the one who discloses a sense that if disclosure is made, then it is all
right to exagerrate.(3) It is important to realize that
transparency may protect the integrity of the research process, but disclosure
does not guarantee that a mind is not “tainted.”
Some people are concerned that
regulations to control COI have gone too far. In 2005 the NIH tightened rules
that banned private consulting with drug and biotechnology companies, and
increased restrictions and disclosure requirements on employees’ financial
holdings.(4) Some believe that these measures threaten recruitment
and retention of able scientists. In 2006, 39% of the NIH scientists who
research diseases and cures say that they are actively looking for new work or
considering leaving NIH because of these tightened COI ethics rules. On the
other hand, 73% of the NIH employees believe that the new rules will boost the
NIH’s credibility with the public. The nagging question that seems to
haunt us all within our free market system is what system of management of COI
does not create disincentives for researchers?
Linda S. Carr-Lee Research Associate
- Hampson, Lindsay A., B.A., Manish
Agrawal, M.D., Steven Joffe, M.D., MPH, et. al. “Patients’ Views on
Financial Conflicts of Interest in Cancer Research Trials,” NEJM 355;22
11-30-06.
- “The Dirt on Coming Clean:
Perverse Effects of Disclosing Conflicts of Interest,” The Journal of
Legal Studies.
- Beamish, Rita. “NIH’s New
Ethics Rules Lead Some to Ponder Jumping Ship,” Washingtonpost.com, Monday
, 10-30-06, p. A15.
- Arlene Weintraub and Amy Barrett,
“Medicine In Conflict,” Business Week, 10-23-06.
Division Members on the
Road and in Print
Armand Antommaria co-presented
with Susan Fox on “End-of-Life Decisions and the Unrepresented, and the
Use of Mediation in Bioethics”, at the symposium on Alternative Dispute
Resolution in End of Life Decisions at The Ohio State University Moritz College
of Law, January 18, 2007. This symposium was co-sponsored by the Ohio State
Journal on Dispute Resolution and the American Bar Association Section on
Dispute Resolution.
Peggy Battin and Leslie Francis
will be attending a meeting on Bioethics and “Biodefense”, at the
John Hopkins School of Advanced International Studies, Washington DC, Feb.
5th.
Jay Jacobson moderated a panel on
“The Medical and Economic Impact of Pandemic Influenza” at the
University of Utah, International Center on January 17th.
Leslie Francis spoke on disability
at the University of Chicago Law School on January 29th. She also attended
hearings of the privacy and confidentiality Subcommittee of the National
Committee on Health and Vital Statistics.
- Jay A. Jacobson, M.D.,
Chief
- Armand H. Antonmaria,
M.D., Ph.D.
- Margaret P. Battin,
Ph.D.
- Jeffrey R. Botkin,
M.D., M.P.H.
- Leslie P. Francis,
Ph.D., J.D.
- Therese Jones, Ph.D.
Program
Associates:
- Ali Choucair,
M.D.
- Howard Mann,
M.D.
- Mark Matheson, D. Phil.
- Susan Sample, M.F.A.
Division Research
Associates:
- Linda Carr-Lee,
M.A.
- Evelyn Kasworm, B.S.
Administrative Assistant:
- Natalie Burbank
- Delores Horn
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