Clinical Editor's Corner

Working With Industry Representatives and Conflicts of Interest in the Cath Lab

Morton Kern, MD Clinical Editor Professor of Medicine Associate Chief Cardiology University of California Irvine Orange, California mortonkern005@hotmail.com
Morton Kern, MD Clinical Editor Professor of Medicine Associate Chief Cardiology University of California Irvine Orange, California mortonkern005@hotmail.com
Your cath lab director is on the speaker’s bureau for a pharmaceutical company that promotes antiplatelet agents. Does this mean you cannot buy this drug to use in the cath lab? Does this mean the doctor cannot perform a procedure with this drug because he has a perceived conflict of interest? Of course not, but it is important to understand and work with our industry and the conflicts of interest which inevitably occur in most businesses, including the business of medicine. Industry and cath lab relationships In the last few years, major universities and hospital systems have limited or prohibited relationships of any kind with industry to demonstrate and avoid undue industry influence on patient care. While I think this process has now moved to the far side of the reasonable spectrum, prohibiting minor amenities like donuts and coffee for educational cath lab conferences and meetings, there is no doubt that the industry presence influences medical decisions. Simple proof is the observation that a company spends millions supporting its product representatives in the field. However, in many ways, the cath lab and our patients remain the beneficiaries of this corporate expense. We need cath lab representatives to bring the new products into the lab and teach us how and why these products work. The decision to use the product is always reserved for the physician in charge of the patient’s care. Every lab has relationships with their industry suppliers. The industry suppliers, of course, depend on the cath lab to use their products. The representative thus has two goals: 1) to promote sales, and more importantly, 2) to direct the appropriate (and of course identify inappropriate) use of their product for the patient’s best care. These two goals should not be mutually exclusive. Good representatives should always advocate appropriate product selection (to the best of their knowledge) to obtain the best outcome for the situation. When the “xyz” stent representative is asked the question, should I use this product, the “xyz” stent, in a calcified LAD when the “abc” stent is known to be better, the answer should be a clear “no,” despite the fact that the representative would lose a sale. In my experience, most representatives have high integrity and understand that the needs of patients trump sales. If a representatives is not performing in this capacity, a career change is in order. While much has been said about the use and abuse of industry as advocates for clinical use of their products, sometimes with limited evidence of benefit, the cath lab must balance the convenience of having a representative around during procedures against the possible undue influence at the expense of best clinical practices. How much influence does a representative have in a cath lab? A TCT meeting abstract from Stanford University (www.aievolution.com/tct0901, TCT abstract no. 551), entitled “Does the Presence of a Corporate Representative Affect Choice of Coronary Stent?” by HoHai Van et al, examined the influence of representatives from stent manufacturers on stent selection. From October 2008 to April 2009, the Stanford doctors looked at visits by stent representatives to the lab that were independent and self-scheduled. Representatives were permitted in the catheterization lab and interacted freely with all operators. The effect of the representative’s presence on implantation of that particular company’s stent was analyzed. Of the 431 stents implanted during the period, 36% were from company A, 53% from B, 6% from C, and 5% from D. The effect of representative’s visit on stent usage demonstrated an increase in use from 40-52% for A, 50-86% for B, 5-22% for C, and from 3-40% for D (Figure 1). The two companies with lowest overall market share had approximately half the total stent implants during the study on the days of their representatives’ visits. Stent C had 46% and D had 50% compared to Stent A, 17%, and B, 25%. This study demonstrated that the presence of stent manufacturer representatives significantly increases stent utilization from their respective companies. It is part of human nature and should be no surprise that the presence of a representative with whom the staff and the physicians have favorable relationship would influence the selection of equipment, given all other clinical factors being equal. However, should any clinical variance or special condition appear, the use of such a device should always be a second consideration to the clinical need of the patient. However, it is very difficult at times to make this distinction. Should industry representatives be banned from the cardiac cath lab? This question is very difficult. Personally, I do not believe this should be the case. I find the representatives bring new information, new products, discussions of how things are done in other labs, and indirect communications among labs in the community about who is doing what. However, some laboratories find the conflict of having representatives in the lab during their procedure too great, and have gone so far as to restrict access to the cath lab, staff and physicians during working hours in the lab. Does this ban from the lab reduce the unwanted influence? I don’t know, but it certainly changes the attitude of the cath lab personnel to their industry partners for the worse. Given the Stanford data above, banning representatives probably seems to be a good idea to many labs. However, I believe that the physician leaders should be mentally strong enough and morally upright enough to overcome this “bad influence.” Should cath lab representatives participate in the procedures in any other way than in a “hands off” advisory capacity? In my view, the answer is “no.” No non-hospital sanctioned person should ever be permitted to touch any equipment related to the patient care. While this is not the case for many of the pacemaker representatives who are requested to program and check the pacemaker devices, and perhaps even assist in the implantation of AICDs, their specific hands-on participation is a big question mark. In terms of good practices, if an error should occur due to their activity, the brunt of criticism will fall on hospital team members and not directly on the ‘hands-on’ representative, who is not part of catheterization team. The liability belongs to the hospital. Should manufacturers’ representatives provide lunch for the cath lab staff? Those days appear to be over in many places (I’m sad to say). Because of the perception and perhaps reality of undue influence, major universities and health delivery systems have prohibited “gifts” of any kind to the employees of the institution. Inducements like lunch, innocuous as it may seem, can bias the users’ selection of equipment. However, I think that these important industry/ cath lab interactions, in the right setting, can provide valuable interactions and educational opportunities. Our medical industry can and should sponsor educational symposia, free of bias presentations, so that the members of the cath team can be educated, physicians can receive information on latest procedures and techniques, and best care can be provided through this knowledge. Industry relationships should not be penalized or demonized, but conflicts of interest should be acknowledged and identified. Major professional societies have established guidelines with regard to both participation in studies, holding of equity, disclosure of relationships when performing procedures, and use of appropriate vendors with whom the physicians and labs have relationships. Overall, I believe that the evolution of the important contributions of the medical industry to the care of our patients has been highly beneficial, if not exceptional. The role of the manufacturers’ representatives in assisting the cath lab staff and physicians should lead to the use of the best techniques for the best outcomes with the least bias at the most reasonable cost for our healthcare system.
References
1. Van H, Yamen E, Blanchard J, et al. Does the Presence of a Corporate Representative Affect Choice of Coronary Stent? Abstract 551 from the Transcatheter Cardiovascular Therapeutics meeting. Available online at www.aievolution.com/tct0901/. Accessed October 12, 2009.