Year: 2007
Type: article
Abstract: We appreciate the interest of Drs Stossel and Romano in our commentary in Mayo Clinic Proceedings on conflict of interest (COI) in clinical practice and its management in an AMC. Dr Stossel raises several interesting questions, some of which were considered during deliberations before approval of COI policies at Mayo Clinic in 2003. Dr Stossel correctly identified a principle inherent in those policies, ie, to encourage scientific rigor in medical research and evidence-based decision making in medical care. We offer the following responses to points raised by Dr Stossel. Dr Stossel challenges our perception that there has been long-standing concern regarding COIs. Conflicts of interest have been on the radar screen at Mayo Clinic for several decades. In 1921, Dr William J. Mayo wrote “Commercialism in medicine never leads to true satisfaction, and to maintain our self-respect is more precious than gold.” Mayo Clinic developed policies designed to govern medical-industry relationships and to address the issue of COI long before the institution of federal regulations in the mid-1990s. Dr Stossel indirectly questions whether our conclusion that potential COIs compromise trust is supported by evidence. At Mayo Clinic, we have conducted patient focus groups that have provided us with unequivocal evidence that our patients do not object to Mayo Clinic physicians being involved in industry relationships. In fact, patients appreciate that the best treatments may originate from industry collaborations, and they want Mayo Clinic and its staff to have relationships with industry. However, the patients in our focus groups sent 2 other clear messages. First, patients at Mayo Clinic want to know about potential COIs for individual physicians and for the institution. Second, they expect Mayo Clinic to manage those conflicts, especially as they pertain to their clinical care. Dr Stossel questions whether the policies proposed may be based in part on envy or on a desire to promote “inquisitional informant behavior.” On the contrary, Mayo Clinic encourages staff participation in the commercialization of inventions. Mayo Clinic has an Office of Intellectual Property that receives an average of 1 disclosure per workday from members of staff who have ready and open access to the office. The resulting commercialization of these inventions provides a source of revenue for the inventor and for the institution consistent with the Bayh-Dole Act. Furthermore, an inquisitorial approach is not adopted in reviewing and managing potential COIs. Consistent with federal regulations, all applications to federal agencies for research funding must be reviewed by a COI Review Board. Mayo Clinic has chosen to apply this process uniformly, with a similar review used for industry and foundation grant applications as well as all for Institutional Review Board and Institutional Animal Care and Use Committee applications supported by intramural funding. In 2003 Mayo Clinic developed standardized and detailed approaches to manage potential COIs (individual and institutional). The management algorithm used is available on request and has been made available to other AMCs whose representatives participate in the Forum on Conflict of Interest in Academe, an organization that formally became part of the Association of American Medical Colleges in August 2006. At Mayo Clinic, the COI Review Board's recommendations for management of actual or potential COIs are widely accepted by staff, with fewer than 10 appeals of an average of 500 reviews conducted per year in the past 3 years. Mayo Clinic's Board of Governors serves as the body to address appeals from staff who disagree with management strategies proposed by the COI Review Board. Our commentary acknowledges the opportunity costs associated with the implementation of such policies. We agree that Mayo Clinic is responsible for educating students and staff about COIs as well as helping them recognize unwarranted marketing claims. Dr Stossel's recent statement in an article in The Wall Street Journal resonates with us too: “If a physician can be influenced into prescribing certain drugs just because he had pizza with a pharmaceutical guy, then it's the fault of his training and not the drug company.”1Stossel TP quoted in The Wall Street Journal April 24, 2006 in Pereira J. Gifts to doctors are widespread: free meals, drugs are often accepted: new survey finds.The Wall Street Journal. April 26, 2007; (Accessed June 13, 2007.): D6http://online.wsj.com/article/SB117754904637982847search.html?KEYWORDS=stossel&COLLECTION=wsjie/6monthGoogle Scholar However, there is a fundamental and strategic difference between Dr Stossel's approach and the one reached by broad consensus at Mayo Clinic. Dr Stossel favors empowering staff and students to report unwarranted claims in marketing, to interrogate offending companies, and to inflict severe punishments for severe misbehavior. Mayo Clinic has adopted a more proactive approach, developing policies that encourage recognition and management of COIs in leadership, research, purchasing, and clinical practice activities, thereby avoiding the need for punitive consequences which by definition occur after the damage is done. Nevertheless, we agree with Dr Stossel that industry inventions and dollars are essential to sustain the academic missions of all medical centers including Mayo Clinic. We also readily acknowledge that our policy is indeed a “work in progress.” We welcome continued discussion and commentary about COIs in general and about our policies in particular. We also appreciate the comments of Dr Romano and wish to clarify that we never implied that physicians in solo or private practice were unable to manage potential COIs. We agree with Dr Romano that the same standards should apply to all physicians. We would respectfully draw attention to the goal of our article (see introduction) to address the management of COIs in clinical practice “in the modern academic medical workplace.” We have no doubt that solo practitioners or groups are able to develop strategies to manage COIs. Dr Romano also refers appropriately to other factors that are beyond the control of the AMC but may have a significant impact on clinical practice. These include constraints on best practice by formularies, health care systems, or health maintenance organizations.2Asch DA Ubel PA Rationing by any other name.N Engl J Med. 1997; 336: 1668-1671Crossref PubMed Scopus (49) Google Scholar, 3Kassirer JP Managing managed care's tarnished image [editorial].N Engl J Med. 1997; 337: 338-339Crossref PubMed Scopus (35) Google Scholar Because our commentary focused on issues that are under the control of the AMC, we omitted those issues that related instead to external entities and that have been the subject of other commentaries in the published literature in the past decade.2Asch DA Ubel PA Rationing by any other name.N Engl J Med. 1997; 336: 1668-1671Crossref PubMed Scopus (49) Google Scholar, 3Kassirer JP Managing managed care's tarnished image [editorial].N Engl J Med. 1997; 337: 338-339Crossref PubMed Scopus (35) Google Scholar, 4Bodenheimer T The HMO backlash—righteous or reactionary?.N Engl J Med. 1996; 335: 1601-1604Crossref PubMed Scopus (92) Google Scholar In summary, the strategies proposed within our COI policies achieve our goal that is to provide the best (and unbiased) care to every patient seen at Mayo Clinic and the obligation we have to respond to patients' expectations that Mayo Clinic will manage any COIs that arise in the clinical care of patients. Divergent Views on Managing Clinical Conflicts of Interest–IMayo Clinic ProceedingsVol. 82Issue 8PreviewTo the Editor: The discussion by Camilleri and Cortese1 on conflicts of interest in medicine, including policy recommendations for addressing them at Mayo Clinic, is more measured than many other such commentaries. Nevertheless, it contains characteristic factual errors and conceptual confusion associated with this contentious topic. The intent of the article and many like it is presumably to encourage scientific rigor in medical research and evidence-based decision making in medical care. The implicit assumption of the conflict of interest literature is that financial motives interfere with these desirable attributes and that nothing short of extensive disclosure and regulation of such conflicts will ensure them. Full-Text PDF
Source: Mayo Clinic Proceedings
DOI: 10.4065/82.8.1014-a
Authors: Michael Camilleri, Denis A. Cortese
Institution: Mayo Clinic
Language: English
Subfield: Pharmacology
Domain: Life Sciences
Open Access status: hybrid
Estimated APC paid: $3,900
OpenAlex ID: W2142810760