Managing Conflicts of Interest in Health Science Research: Ethical Issues and Solutions, Papers of Geriatrics

Download Managing Conflicts of Interest in Health Science Research: Ethical Issues and Solutions and more Papers Geriatrics in PDF only on Docsity! Recent research on financial Conflict of Inter- est (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 dis- closure of the researchers’ financial inter- ests.1 If patients are not concerned with potential COI, why ought others be con- cerned? 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 surviv- ing 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 discus- sion 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 con- cerns. Incentives and potential bias: avoiding the “tainted mind” Management of COI takes on greater impor- tance 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 disap- pear. Our free market system is based on the incentives that money provides. There- fore, the claim that scientists are not influ- enced 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 in- deed 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 re- search process. Bias arises at an uncon- scious level. If there is a “tainted state of mind” that comes from being incentivized with money, what is a significant tie to busi- ness 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 profes- sions. 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 uni- versity labs to hold patents on their discover- ies. Universities crossed into the commercial world, licensing findings to companies and sharing royalties with MDs and PhDs in aca- demic labs who were responsible for these discoveries. 2) When HMO’s began to reduce physician pay, doctors turned to drug compa- nies who were eager to hire them to give talks and to consult to promote their prod- ucts. The Bayh-Dole act sought to speed up the timeline from basic discovery to application. The Bayh-Dole act motivates by allowing aca- demics 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 Volume 18 , Issue 2 Publ ished by the Divis ion of Medical Ethics and Humanit ies of the Departments of Internal Medicine at LDS Hospita l and the Univers i ty of Utah School of Medicine The nagging question that seems to haunt us all within our free market system is what system of manage- ment of COI does not create disincentives for researchers? I N S I D E T H I S I S S U E : Managing Medical Conflicts of Interest 1-2 Evening Ethics 3 Division Members Activities 3 Calendar 4 February 2007 M E D I C A L E T H I C S I N U TA H MANAGING MEDICAL CONFLICTS OF INTEREST Page 2 Volume 18 , Issue 2 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 pro- vided 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 Mar- tin 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 re- searchers 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 po- tential conflicts, with some journals rejecting papers from those who are closely tied to companies. • 2005 expansion of Continuing Medical Education guide- lines 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 re- search 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 com- panies, and increased restrictions and disclosure require- ments 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 employ- ees 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 man- agement of COI does not create disincentives for research- ers? Linda S. Carr-Lee Research Associate 1Hampson, 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. 2“The Dirt on Coming Clean: Perverse Effects of Disclosing Conflicts of Inter- est,” The Journal of Legal Studies. 3Beamish, Rita. “NIH’s New Ethics Rules Lead Some to Ponder Jumping Ship,” Washingtonpost.com, Monday , 10-30-06, p. A15. 4 Arlene Weintraub and Amy Barrett, “Medicine In Conflict,” Business Week, 10-23-06.