Appendix C
Scenarios and Rapporteur Summaries

APPENDIX C1. SCENARIO I

Dr. Limestone is a professor of medicine in the Department of Preventive Medicine at State University and a recognized expert in the diagnosis, prevention, and treatment of osteoporosis. An internist, Dr. Limestone devotes 25 percent of her time to teaching and research at State and 25 percent of her time to private practice and related outside activities. The remaining 50 percent of her time she devotes to responsibilities as chief of health policy at the Quadrangle Corporation, a private non-profit institution associated with the university that conducts policy research in a variety of scientific and technical fields. Quadrangle is funded by federal and state agencies and by foundations and other private sources. Dr. Limestone is the principal investigator of a PORT awarded by AHCPR to Quadrangle to evaluate current management strategies for the prevention and treatment of osteoporosis.

As a member of the Academy of Internal Medicine (AIM), a medical professional society, Dr. Limestone serves on the 10-member Technology Assessment and Medical Practices Committee that meets three times a year. The committee is charged with developing and issuing statements on the safety, effectiveness, cost-effectiveness, and related guidelines for the appropriate use of new, generally used, and potentially obsolete procedures and practices. Committee members serve three-year rotating terms and receive no payment for their services other than travel and out-of-pocket expenses related to their committee work. In addition to responding to requests for guidance from the AIM membership, the committee fields approximately ten requests per year from government (usually concerning Medicare) and private sector third party payers for statements regarding procedures and related guidelines for appropriate use.



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Patient Outcomes Research Teams: Managing Conflict of Interest Appendix C Scenarios and Rapporteur Summaries APPENDIX C1. SCENARIO I Dr. Limestone is a professor of medicine in the Department of Preventive Medicine at State University and a recognized expert in the diagnosis, prevention, and treatment of osteoporosis. An internist, Dr. Limestone devotes 25 percent of her time to teaching and research at State and 25 percent of her time to private practice and related outside activities. The remaining 50 percent of her time she devotes to responsibilities as chief of health policy at the Quadrangle Corporation, a private non-profit institution associated with the university that conducts policy research in a variety of scientific and technical fields. Quadrangle is funded by federal and state agencies and by foundations and other private sources. Dr. Limestone is the principal investigator of a PORT awarded by AHCPR to Quadrangle to evaluate current management strategies for the prevention and treatment of osteoporosis. As a member of the Academy of Internal Medicine (AIM), a medical professional society, Dr. Limestone serves on the 10-member Technology Assessment and Medical Practices Committee that meets three times a year. The committee is charged with developing and issuing statements on the safety, effectiveness, cost-effectiveness, and related guidelines for the appropriate use of new, generally used, and potentially obsolete procedures and practices. Committee members serve three-year rotating terms and receive no payment for their services other than travel and out-of-pocket expenses related to their committee work. In addition to responding to requests for guidance from the AIM membership, the committee fields approximately ten requests per year from government (usually concerning Medicare) and private sector third party payers for statements regarding procedures and related guidelines for appropriate use.

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Patient Outcomes Research Teams: Managing Conflict of Interest Dr. Limestone is also on the 75-person medical reference panel of the Piecerock Insurance Company. Panel members are on retainer to Piecerock. Each member receives $100 per hour, and can devote no more than 20 hours in any one week to this work. In the past two years, Dr. Limestone has devoted approximately 5 hours per week to medical reference work for Piecerock. In most instances, panel members in appropriate medical specialties provide consultation regarding a variety of issues related to insurance claims and related coverage issues referred to them by the medical director of Piecerock. On occasion, panel members are called upon to review new or revised company policies on the coverage of medical and surgical procedures. Dr. Limestone has also held many consultancies to pharmaceutical companies over the last 20 years. Several months after the announcement of the PORT award to Quadrangle, Dr. Limestone has been offered a consulting arrangement from the Pharmatek Company to obtain her insight and guidance on Estrocal—451, a new drug being developed by the company for the management of osteoporosis. Estrocal—451 is currently undergoing Phase II clinical trials. Pharmatek currently has no drug on the market that has been approved by the FDA for the management of osteoporosis. The consulting agreement with Pharmatek would provide $1,000 per day for up to 10 days of Dr. Limestone's time during calendar year 1990, plus reimbursement for travel and out-of-pocket expenses associated with this consultancy. As part of the consulting arrangement, Dr. Limestone is asked by Pharmatek to agree to the following: Without prior Pharmatek approval, she may not use or disclose any proprietary data, information, or knowledge pertaining to the research, development, marketing or any other aspect of Estrocal—451 or of any other of the company's products. Any inventions or discoveries that she may make or transfer to practice as a result of this consulting agreement, regardless of their patentability, would be the sole property of Pharmatek. She may not provide consulting services to any other person or entity on matters pertaining to the areas covered by the agreement for at least one year from the start date of the consulting agreement. At the end of 1990, or at any time before then at the request of Pharmatek, she must return all papers, computer files, and other documents that the company has provided to her in connection with the consultation.

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Patient Outcomes Research Teams: Managing Conflict of Interest Discussion of Scenario I David Blumenthal, M.D.1 I was pretty optimistic about the way the session started out because we ran pretty quickly through a series of topics that we could have stumbled on. First we dealt with the issue of conflict of commitment. The regular university rule, which is true of my academic institution, as well as many others, that you are allowed a certain number of consulting days seemed to go down pretty well with everybody. There seemed to be ready acceptance of the idea that it is acceptable for faculty members to exceed time rules concerning conflict of commitment—such as the 50 days a year rule—in the case of a closely affiliated non-profit organization. There was no discussion of what would happen if this had been a for-profit spinoff of the university, and perhaps we can hold that for another discussion. There was a discussion about the importance of following due process in formulating guidelines or recommendations in affiliated institutions or completely independent institutions. For example, in the Academy of Internal Medicine case, there seemed to be agreement that as long as the process used to formulate a recommendation was open and that disclosures of conflicts were made, then participants didn't have to worry about getting sued, and it was okay to charge a fee. Whether it was okay to make a profit for making recommendations was not discussed and is also an issue that I am sure would come up if we followed this issue to its logical conclusion. The question of who should monitor faculty was raised briefly: the department chair, the university, nobody at all—again, this is not a trivial matter when it comes to actually specifying in a practical way how you go about handling disclosures, following up the results of disclosure, following up on conformance with rules if these are ever actually formulated. As we anticipated, the issue was really joined over conflicts of interest resulting from consulting, which was what this case was meant to illustrate and I think did a fairly good job of illustrating. The most basic question related to consulting was never directly raised—whether consulting is an acceptable activity for PORT participants. There seemed to be a sense that, yes, it is alright for PORT members to consult. In this regard, one issue that was not discussed, but which has 1   Dr. Blumenthal, who was a member of the IOM committee, is Senior Vice President at the Brigham and Women's Hospital, Boston

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Patient Outcomes Research Teams: Managing Conflict of Interest been critical in the deliberations of some universities, like my own, is whether PORT work is ''clinical'' work or whether it is more like preclinical or laboratory research. Some universities have chosen to formulate different standards for consulting with respect to clinical and non-clinical work. I think that is an issue of some interest which should be pursued further. Conflicts from consulting in clinical work are sometimes viewed more skeptically than non-clinical things. If consulting is in, then, we get into a second level question, which seems to have been raised repeatedly here in many different forms; that is, what is in and what is out among the various types of consulting that faculty can do? One issue was whether the type of institution or company investigators consult for has some importance. There was a general sense that consulting to insurance companies seemed to be more comfortable than consulting to a drug company. Professor Barber raised quite explicitly the question of the reputation of the company, implying that this should be taken into account. There was the issue of the amount of money involved and the amount of time involved with a particular client or consulting institution. I heard differences of opinion about whether the income in relation to salary in the university ought to be a factor considered. If the compensation is very high, compared with university salary and to work performed, that seemed to make some people uncomfortable. One difficult question concerned what it is appropriate for a consultant to disclose. Some felt that PORT investigators had to be scrupulous not to share with commercial employers any unpublished study results. Since this would require constant vigilance on behalf of a consultant, commentators asked whether it was practical for the right and left brains, as it were, of the consultant to remain detached in this way—in other words, whether this non-disclosure standard could be met. In my mind, however, this issue of confidentiality hints at a more fundamental underlying question: what is the purpose of PORT members consulting to commercial entities? What benefit does this activity have, especially for society at large? What are the attendant risks? Certainly in the biomedical research area, which is one that most universities are now pretty comfortable with, the disclosure of unpublished information has been acceptable. Indeed, the fact is that one of the reasons for these consulting relationships is that people bring to them a vast range of information that can be transferred somewhat more rapidly in a consulting relationship than it can be in published form. So, the question is if you can't disclose the unpublished content of your PORT work, does that diminish or fundamentally interfere with the purpose of consulting?

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Patient Outcomes Research Teams: Managing Conflict of Interest Participants raised the inevitable question of whether we should be concerned only with real conflict of interest or whether appearance should be a very important factor in determining what is allowable and what is not. I am sure there will be differences of opinion on this. Should the number of relationships on the part of a PORT participant be a factor? There are any number of possibilities for line drawing there, but it clearly is one of the factors that was troubling to people in the audience and on the panel. One unaddressed problem concerns how to review conflicts of interest in universities. There must be a balance between rule-making and evolution of practice, or the use of a "case law" approach. At my particular institution we have decided not to draw many firm rules but allow precedent developed over time to be dominant. This was one of the issues that was raised in relationship to the role of the Institutional Review Board (IRB). Do we want an IRB-like structure and if we do, how much license should it have to approve and disapprove particular cases? The discussion of this scenario also addressed some questions related to what technical terms should be incorporated into a consulting relationship. How do you protect a university's right to information? How do you protect the organization to which the individual PORT director or PORT member is consulting? What about exclusivity in consulting? Is that allowable? Allowable by whom? By the university, by the federal government? What happens when more than one university and thus, multiple sets of policies are involved? In most cases, when individuals are subject to multiple policies, it is usually the most stringent terms that seem to govern. When university rules and federal rules are in conflict a side issue is, should this pattern prevail? What about the case of multiple people from multiple different universities? Clearly, there is an issue of consistency that needs to be addressed. That covers most of what I thought I heard this morning. I am sure that there were a number of other issues. The issue that struck me as implicit and in some ways most fundamental was this matter of what is the purpose of permitting relationships that pose potential conflicts of interest? What are the societal stakes involved here? If there is no benefit to those relationships, then why do we permit all the problems that may arise from them? Certainly in the biomedical sciences there is a general sense that there are benefits and that the benefits have to do with the technology transfer process. That is certainly the rationale behind the federal legislation that governs in this area and the question is, if that same benefit is present here, what do constrictions around disclosure and non-disclosure mean in

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Patient Outcomes Research Teams: Managing Conflict of Interest terms of that technology transfer process? Who is being protected, and how much of the appearance of conflict do we want to allow in order to capture those benefits? APPENDIX C2. SCENARIO II2 AHCPR has awarded a grant to Golden University for a PORT to assess alternative modalities for the management of coronary arteriosclerosis. Among the medical, drug, and surgical modalities, some are distinctly device-embodied, including laser atherectomy and balloon angioplasty. The following three modalities would be reviewed: First arm: a high daily-dose regimen of Deplak; it appears to be safe to use before signs of myocardial infarction and is currently the most promising nonsurgical intervention Second arm: laser atherectomy Third arm: balloon angioplasty All other aspects of care will be controlled for. Administrative claims data for a total of 5,000 patients will be reviewed retrospectively, split fairly evenly across the three modalities. This 5-year PORT will also provide a total of three years of prospective observation. The PORT will require one year to get started and to identify and enroll patients to collect health status and quality-of-life measures not generally found in medical records or claims data; it will take the last year of the grant to analyze its data. CARDPAK: Start of Study In addition to data from insurance claims files and medical records, a key component of this 5-year study—specified in the AHCPR notice of grant award—is to test the utility of the computer software package CARDPAK in the study of arteriosclerosis. CARDPAK uses a specially designed health status index and simulation program to assess and project changes in cardiovascular health status and quality of life in patient populations subject to diagnosis and treatment of heart and respiratory disease. Dr. Hart, a cardiologist at Golden University and the principal 2   Some of the elements in this scenario are adapted from one written for the IOM workshop by Dr. Sal Gorgiani and Jane Newman of Pfizer Pharmaceutical, Inc.

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Patient Outcomes Research Teams: Managing Conflict of Interest investigator of the Golden PORT, developed CARDPAK; the university owns the rights to CARDPAK, and Dr. Hart receives a share of the royalties paid for its use. Two other physicians participating in the PORT are Dr. Stenose a cardiac surgeon who is an expert on cardiovascular devices and on the faculty of Golden and Dr. Atherton, a cardiologist in the community. Her patients will be recruited for participation in the PORT study. Cathco Inc. is a medical device and instrumentation company. Cathco has developed a highly innovative balloon-tipped catheter for use in angioplasty. The new device is currently undergoing clinical testing under an investigational device exemption in preparation for submittal of a premarket approval application to the FDA. Cathco management knows that at least one major health care product corporation is considering acquiring Cathco, and that success of its new catheter would significantly enhance the company's asking price. As the Golden PORT is nationally recognized in the study of the management of arteriosclerosis, Cathco has approached the PORT concerning a proposed research contract. Specifically, Cathco is offering $2.5 million to the Golden PORT over a 4-year period to conduct a series of studies of Cathco devices, beginning with the new catheter. Cathco is especially interested in demonstrating improvements in patient outcomes and cost-effectiveness among patients who have undergone procedures with its products, e.g., angioplasty using its new catheter. Cathco has made this offer contingent upon the availability of CARDPAK for use in the proposed study. Although Cathco would follow through on the offer if it simply had to pay the going royalty fee to Golden, it prefers to acquire CARDPAK outright, and has offered $200,000 to the university for it. If Cathco were to acquire CARDPAK, Dr. Hart would continue to receive his share of royalties indefinitely, and Cathco would honor any licensing arrangements in effect as of the date of the transfer of CARDPAK from Golden to Cathco. Cathco would retain ownership of the CARDPAK data. PORT members recognize that the Cathco offer would provide an important boost to their overall research capacity. Although none of Cathco's current product line is involved in the Golden PORT study now supported by AHCPR, the PORT study does involve a product manufactured by one of Cathco's competitors, a Swiss company. Outside Activities of the PORT Members The principal investigator for this PORT project, Dr. Hart, is a recognized expert in laser atherectomy at a medical center in the midwest

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Patient Outcomes Research Teams: Managing Conflict of Interest and has published more than 60 primary research articles on this topic, including eight-year survival data on several hundred patients derived from randomized clinical trials (RCTs) of alternative invasive approaches to arteriosclerosis. He is also frequently an invited speaker at international conferences on these techniques. Another member of the PORT, Dr. Stenose, has been asked by the FDA to serve on its advisory panel on cardiovascular devices. According to the financial disclosure form required by Golden University of all of its professional staff, Dr. Stenose has no financial interest in any health-related company, though his daughter owns $5,000 worth of stock in Cathco. Dr. Stenose does not currently hold stock in Summit Laboratories, a company that manufactures Deplak. Until two years ago, Dr. Stenose had significant holdings in Summit. He sold his holdings after he completed a Phase III study of Deplak sponsored by Summit. This study contained very positive information supporting Deplak, and after presentation of the data at a conference, led to a stock price increase of $5 per share. This is disclosed on Dr. Stenose's financial holdings statement. Dr. Atherton currently has stock holdings in several pharmaceutical and medical supply companies that market products used in surgical treatment of arteriosclerosis. These combined holdings amount to less than 10 percent of her total practice income. Preliminary Results of the PORT Analyses: Four Years into the Study Although results of the PORT investigation showed slightly better patient outcomes for the second and third arms than for the first arm, the differences among the three treatment groups were not statistically significant at the 0.05 level. The cost analysis indicated the treatment arms using surgical techniques to be substantially more costly. Despite these findings, Dr. Hart is convinced that prospective data on invasive techniquest collected over many years at his center supports laser atherectomy as a preferred technique, particularly since recent advances in the technique seem to have improved survival rates. He is attempting to persuade the other PORT investigators that his prospective RCT data on eight-year survival rates should outweigh the findings of their three years of "case-control" observational data in the PORT study and that publication should be delayed pending longer-term survival data.

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Patient Outcomes Research Teams: Managing Conflict of Interest Discussion of Scenario II Marcia Angell, M.D.3 First, I would like to compliment the person who dreamed up this scenario. When I first read it, all of these intertangled financial connections seemed too fantastic. Then I read it again, and I realized that it represented real life rather well. What I would like to do is very briefly summarize what I heard as the salient features of this scenario, because it is very complicated. The PORT study is comparing a medical treatment, Deplak, with angioplasty and with laser atherectomy for the treatment of coronary artery disease. It thus has three arms. It also includes, evidently, the charge that a software package, CARDPAK be tested as a method of analysis, not just used. Into this very brief scenario leaps Cathco, a company that makes a rival catheter to the one being evaluated by the PORT. Cathco says to one of the three major members of the PORT, "We will give you, Dr. Stenose, two and a half million dollars if you look at our catheter independently of your function as a member of the PORT." So, with that brief recapitulation, what do we have? We have three major members of the port. We have Dr. Hart, who designed CARDPAK and is receiving royalties on it and who at the end doesn't like the way the PORT study came out and decides he doesn't want to publish it. We have Dr. Stenose--this is quite a cast of characters--who was offered the two and a half million dollars to study the Cathco's catheter and who in the scenario--Alex didn't mention this--sits on an FDA panel reviewing a Cathco application. His daughter, furthermore, owns stock in Cathco. Stenose, himself, did have stock in Summit, which was the company that developed Deplak, but he sold that at a tidy profit at exactly the right moment. Thus, he has quite a track record in financial entanglements. Then we have Dr. Atherton, who wasn't mentioned, who owns stock in just about everything just in case. So, there are our players. The panel began by addressing the issue of how industry might properly give money to researchers and institutions—if they may. Dr. Budetti had some reservations about whether they should at all, but the others addressed themselves only to finding the right way to do it. They were asked whether it was proper for Cathco to offer Dr. Stenose, through his institution, two and a half million dollars to be used for Dr. Stenose's 3   Dr. Angel is the executive editor of the New England Journal of Medicine. She is a graduate of Boston University School of Medicine, where she trained in internal medicine and pathology, and she is co-author of the textbook Basic Pathology. She writes frequently on research and clinical ethics.

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Patient Outcomes Research Teams: Managing Conflict of Interest research on their catheter. Most of the panel felt at the outset that that was all right. Nothing was said about whether Dr. Stenose would do the analysis of the study or whether he would just be a hired gun who supplied patients, with the analysis and interpretation being done by Cathco. I think that is an important question that wasn't addressed. Another question that was addressed was whether the company would be granted rights to restrict publication of the results or to dictate the terms of publication. The panel felt that their approval of this arrangement was contingent on there being no such restrictions, that the investigators could publish the data from the study as they saw fit, although the panel did agree that it might be permissible for the company to see the results of the study before publication, provided the delay was not too great. In all of this, there was the incidental discussion of the ownership of stock by Stenose's daughter. She owns stock in Cathco and it seemed to matter to everyone how old she was and how much she owned. It was decided that if she wasn't too young and she didn't own too much, it was permissible. This was the skeleton of the consensus on how investigators should receive money from industry. Then the question became more complicated by introducing the fact that Stenose was a member of the PORT. Was it permissible for him to look at Cathco's catheter and at the same time be a member of the PORT, which was investigating a rival Swiss catheter as a part of its charge? Most members of the panel seemed to think that it was permissible if the money continued to flow not directly to Stenose but through the institution, with the usual guidelines that the institution would put on the receipt of such money, and if the two studies were entirely separate—that is, if the Cathco study were separate from the PORT study. But some members of the panel felt that to carry out these two investigations simultaneously, while receiving this much money from Cathco, compromised the independence of Dr. Stenose. There was no attention given to the fact that Stenose, with his PORT hat on, was going to be evaluating a competitor, who was not paying him, but with his Cathco hat on, he was going to be evaluating the Cathco catheter and getting paid for it. Now, there was some talk about how many catheters one can evaluate at once, and there was some kind of scientific concern that if one were evaluating too many devices or drugs at once, it might somehow affect how objective one could be. There was no focus, however, on whether money is changing hands from the owner of one product as opposed to the other. Dr. Budetti disagreed with the general view that because the Cathco arrangement is a common way for research to be funded by private

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Patient Outcomes Research Teams: Managing Conflict of Interest enterprise, it is proper. He wanted to separate what was common from what was wise. He also mentioned—I thought this was interesting—that researchers were too valuable a commodity to waste as hired guns doing whatever research private companies pay them to do. Dr. Hart, who developed CARDPAK, which is owned by his institution, gets royalties. The panel felt in general that this arrangement is all right, probably in part because this, too, is very common. Hart, as a member of the PORT, is required by the agency to use CARDPAK, the software program that he developed and on which he receives royalties, as a part of the PORT project. Now, I can't imagine—this is the only part of the scenario that I can't imagine would happen in real life—that he would be asked to evaluate a product that he has both a strong intellectual and a strong financial interest in. CARDPAK is his creature and the better it does, the better he does. So, just on scientific grounds, I am not so sure that I would want Dr. Hart to be evaluating CARDPAK. The panel didn't look at CARDPAK as something that was being evaluated as a part of the PORT project, but instead just the method to be used. The panel seemed to feel that if, in fact, it had already been evaluated and it was a reasonable method to use and the idea for using it came from outside the PORT, then that was all right. It strikes me that if the agency had no interest in evaluating CARDPAK, it would be peculiar to tell researchers what their methods must be, but there it is. There was some discussion of the fact that Cathco wanted to buy CARDPAK, which would be used in the study that they were asking Dr. Stenose to do. Nobody knew quite what to make of that because I think nobody knew whether this would mean that the company would bury CARDPAK or whether they would merely collect royalties, as the institution was now doing. The fact that Dr. Stenose had once owned stock in Summit and sold it at a profit was taken by the panel members not to be a problem in the present context, but perhaps to be of value in alerting people who care about these things that he might be fairly insensitive to ethical considerations. At the end of the PORT study, Dr. Hart disagreed with its results and decided that he didn't want to publish them yet. He said he was also involved in a separate, clinical trial of invasive approaches to arteriosclerosis that was a better study and gave different results. We are not told whether his other study has been completed and published; the implication is that it has not been published. The other members of the PORT are evidently to take Dr. Hart's word that it is a better study, and it shows something else. The panel, quite rightly, said "no" to altering the handling of the PORT results for this reason.

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Patient Outcomes Research Teams: Managing Conflict of Interest APPENDIX C3. SCENARIO III4 Dr. Sharp is the president and CEO of British Medical Intelligence, Limited (BMI), a data processing and utilization review company that developed a highly sophisticated computerized patient record system. BMI currently operates in 2,000 physicians' offices in the United Kingdom. The system links physicians' offices with a centralized data bank in London that enables BMI to generate detailed information on physicians' therapeutic decisions and practice patterns. In addition, the system can be programmed to provide drug interaction warnings and prompt physicians to consider alternative therapies (including specific products and brand names) when they enter certain diagnoses or orders for medical equipment or pharmaceutical products. BMI sells the data it generates to pharmaceutical, device, and equipment manufacturers, and contracts with the National Health Service and private insurance companies to convey current clinical information to practicing physicians. BMI recently entered into a joint venture with Unicorn, Inc., a U.S.-based third party claims processor, and Mega Pharmaceuticals, the largest U.S.-based pharmaceutical company with a full line of top selling therapeutic agents, including agents for the management of all major chronic diseases such as hypertension and diabetes. The joint venture will install computers in 5,000 physicians' offices in the United States and will sell data on physicians' prescribing patterns to pharmaceutical companies, contract with insurers to develop patient and physician profiles, and contract with health maintenance organizations to assist with implementing their utilization controls. Unicorn is responsible for the computer set ups and data processing. Mega is providing the capital for purchase of the computer hardware and placement in the participating physicians' offices. Dr. Sharp and his development staff from BMI will oversee the 18-month start-up phase of the U.S. venture. Dr. Sharp's practice monitoring and management system is the most advanced in the world. Others have tried to establish similar systems, but have failed. Dr. Sharp owns all foreign and U.S. copyrights on the software that drives the system. Because the BMI system combines a problem-oriented and diagnosis-based medical record with the capacity to measure the outcomes of various medical interventions at the level of the 4   This scenario was contributed by Michael Pollard, Esq. of Michaels and Wishner. Mr. Pollard was a member of the IOM committee.

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Patient Outcomes Research Teams: Managing Conflict of Interest physician's office, and is a proven success in the United Kingdom, the Agency for Health Care Policy and Research is interested in entering into a collaborative agreement with BMI in order to gain access to the patient and physician practice data that will be generated by BMI in the U.S. Prestige University, a private institution that has a PORT concerned with the outpatient management of diabetes, is also interested in establishing a working relationship with BMI and Dr. Sharp. Data on outpatient, office-based physician care from the BMI-Unicorn-Mega joint venture would be used for the PORT. Prestige plans to offer Dr. Sharp an adjunct professor appointment and intends to tell him that he will have access to graduate students to assist him in adapting his system to medical practice, in the U.S. The Mega Pharmaceuticals Foundation, a not-for-profit, grantmaking institution established by Mega Pharmaceuticals, makes grants of approximately $1 million annually to medical researchers on the faculty of Prestige University Medical School. Discussion of Scenario III Michael Pollard, Esq. The panel did a very good job of bringing out the key points in the case. We began our discussion by focusing first on the mechanics of the system that Dr. Sharpe had developed. There were concerns about invasion of physician privacy and possible disclosure of confidential information having to do with physician prescribing patterns. There was some disagreement among the panel members about how this ought to be handled, and the panel did not reach a consensus position. The panel talked about the prompting function and how that might be misused selectively to prompt the use of drugs marketed by Mega Pharmaceuticals, but Alex clarified that we should assume that was not going to be used in such a way as to advantage Mega. The use of the patient data by insurers possibly to exclude certain groups raised a number of concerns about the appropriateness of that practice. The panel felt fairly strongly that there was a big difference between physicians who would volunteer to participate in the BMI system and physicians and patients who would be involuntary participants in such a system. With regard to involuntary participants, it would be very important to respect their privacy. Everyone felt a little bit more comfortable once we determined that the physicians' participation would have to be voluntary. The question of sale of the information gathered by the software system, however, was one that continued to bother a number of participants, and we did not reach any resolution on that aspect of the scenario.

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Patient Outcomes Research Teams: Managing Conflict of Interest On the issues concerning possible collaboration with Prestige University, the university people on the panel felt much more comfort with the notion of contracting with the BMI/Unicorn/Mega joint venture than with a more collaborative sort of process, and the panel did not explore how a collaborative process might work. The use of graduate students was another issue the panel addressed. Here the question of exploitation and whether the experience of the graduate students in working with Dr. Sharp—in trying to adapt his system to the U.S. system—would be a bona fide learning experience for the students. If it were, then it would probably be alright. With regard to the Mega Pharmaceutical Foundation support, the initial reaction by some panel members was that this was not an overt conflict of interest, but we returned to this question, thanks to Mr. Hutt, in terms of the so-called laundering issue—whether it makes a difference if the support flows to the university or goes directly to the individual researcher under some kind of consulting arrangement. The panel agreed that it was very important to engage in full disclosure, and to have careful review of the design of the research and the individuals receiving grants or consulting monies. There might be some safeguards that could be employed if there were a question about appropriateness, such as using a co-principal investigator. The danger of bias was a theme that pervaded much of the discussion by the panel. Again, Mr. Hutt raised some important questions. He stressed the need to focus both on sources of financial bias and on other forms of bias, and he suggested ways to deal with it including full disclosure and a sound peer review mechanism within the university. This would include review both of the results of research and a mechanism to look at the design of studies and some of the structural elements that go into setting up a study. The panel concluded by looking at the issue of an exclusive license for the Prestige University for the use of BMI data. The panel had a considerable discomfort about this arrangement and a reticence to permit that kind of monopoly by one university in an environment where presumably researchers engage in some degree of professional collegiality and sharing of information. Some of the discomfort about exclusive use of data may have arisen from an assumption that many of us are making, that PORTs are probably going to specialize in one area and that they will not be crossing over into other areas. There is nothing to stop that happening, however, and this case provided an opportunity through the BMI database for a PORT to develop the capacity to look at procedures across a wide array of interventions.

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