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Table of Contents
Getting the Facts on Conflicts of Interest The July 9th and 10th issues of the San Jose Mercury News featured major stories on conflicts of interest focusing specifically on the Stanford University School of Medicine. I am confident that there were many reactions to these articles by members of our university community as well as by the public. Conflict of interest is an important topic that has many implications for both not-for-profit and for-profit organizations. While some of the issues surrounding conflict of interest are straightforward, others have many nuances that require more careful consideration and explication. To help make the facts as clear as possible, our Office of Communications and Public Affairs has posted an informative factual review of conflicts of interest as they relate to universities and academic medical centers. I would strongly encourage you to visit their website (see: http://mednews.stanford.edu/conflict/) and review the materials they have posted. Among the information provided is an informative Q&A section that addresses some key questions including:
As you likely know, I have also written a number of commentaries on the topic of conflict of interest in previous Dean's Newsletters. I have listed a few of these articles below along with their URL in case you wish to refer to them.
My own reaction to the Mercury News articles written by reporter Paul Jacobs is that he attempted to lay out a balanced analysis in the first of the two reports, although he seemed to convey a bias and sometimes did not understand the difference between consulting and conflict of interest. While he spent nearly 8 months interviewing various faculty and staff at Stanford, there were also some facts that he simply got confused about or never appreciated. Accordingly, I wrote an op-ed piece on his articles that appeared in the Friday July 14th issue of the SJ Mercury News, which I am taking the liberty of reprinting below:
I recognize that we have continued work to do in this broad topic of conflict of interest and interactions with industry. In my last Newsletter (see: http://deansnewsletter.stanford.edu/archive/06_26_06.html#1), I detailed some of the forward-looking policy changes we are planning to implement in the area of industry interactions. We also need to continue our wide-ranging discussions with the dual goals of assuring that the highest quality research is performed at Stanford and that findings which can impact human health are translated as rapidly at possible in tandem with doing all that we can to protect and enhance the public trust. | On June 29th I participated in two events that permitted me to offer some reflections on academic medicine and medical centers. The first was the Campaign College, which included the University-wide development staff, where I participated in a panel with Martha Marsh, President and CEO of Stanford Hospital & Clinics, and Doug Stewart, Associate Vice President for Medical Development. The second event was a panel discussion on "Stanford in the Next Decade" for University senior managers, where I again participated in a panel, this time with Martin Shell, Vice President for Development, and Dr. Artie Bienenstock, Vice Provost and Dean of Research and Graduate Policy, Professor at SSRL and of Materials Science and Engineering and of Applied Physics. It struck me that many in our community do not understand what an academic medical center is or how it works to achieve its missions. That is not a surprise given the highly variegated organization and governance that defines academic medical centers -- including Stanford University Medical Center. Accordingly, it seems reasonable to offer some comments and reflections on the comparative composition of academic medical centers and how Stanford is distinguished among them. Academic medical centers are a product of the 20th century and have grown up in quite different manners and configurations in various cities and states. Since their inception, they have been characterized by different organization and governance structures (which not infrequently change at the same center) and with different areas of emphasis and expertise, albeit with some common denominators. At least at one level, all academic medical centers share a commitment to education, research and patient care. However, the adage that "if you have seen one academic medical center, you have seen one academic medical center" still rings true. This makes direct comparisons challenging and clearly impacts the experience of students, faculty and staff at various institutions. From their beginnings, academic medical centers have included schools of medicine, one or more teaching hospitals, and physician (or faculty) practice plans. Among the 125 academic medical centers in the USA, the relationship among these three entities varies considerably. For example, most schools of medicine are affiliated with a parent university (as is the case with Stanford) but some medical schools (e.g., University of California at San Francisco, Baylor College of Medicine, University of Texas-Southwestern, Oregon University of the Health Sciences) are "free-standing," with their sole mission being health sciences. Further, a number of medical schools are part of a larger health science complex that may include schools of public health, dentistry, nursing, or pharmacy, among others. In addition, some academic medical centers are physically connected to their parent university (as is the case for Stanford) whereas others are separated by miles (e.g., Harvard, Columbia, Johns Hopkins) or are even located across an entire state (e.g., Cornell-Weil College of Medicine). Further, some medical schools appear to dominate the university in their size and, in some cases, prestige (e.g., Johns Hopkins, Washington University, University of Rochester) whereas others remain more balanced within the university, even to the point of established limits on faculty size to assure that the medical school doesn't become too dominant (e.g., Yale, Chicago -- and of course Stanford). The character of medical schools and universities is further influenced by whether they are private or state funded and whether there are formal or informal mandates guiding their direction. For example, some medical schools are clearly organized and supported to train practicing physicians, with a special focus on assuring that graduates serve regional and state-wide interests (e.g., University of Washington, University of North Dakota) whereas others are more research focused and attempt to admit and train students who will pursue careers in research or academic medicine. Stanford falls into this latter category. In addition to their organization, medical schools share a common goal in undergraduate medical education, although the number of students they admit and the types of students educated and trained vary widely. Most medical schools have a four-year curriculum generally comprised of two years of preclinical study and two years of clinical rotations. Indeed this has been the general configuration of medical education since Abraham Flexner's 1910 Report entitled "Medical Education in the United States and Canada." More recently a number of variations on this traditional theme have emerged, primarily in order to better organize the basic science curriculum into a more integrated systems-based approach (e.g., cardiovascular system, renal) and to introduce early into the curriculum problem-based learning and small-group discussions. Stanford has always been unique, first by having a "five-year plan" when the School moved from San Francisco to the Stanford campus in 1959, which created flexibility and the opportunity for students to engage in research. This has been significantly refined and enhanced by the introduction of the New Stanford Curriculum in the Fall of 2003 that requires each student to choose a "Scholarly Concentration" designed to focus her or his energy in a specific analytic area that promotes scholarship and research (see: http://med.stanford.edu/md/). Furthermore, medical schools vary in whether they train only medical students or also offer advanced degrees in the biomedical sciences. Again, there is a broad range but Stanford is clearly at the far end, since we educate an equal number of PhD candidates and MD students. In addition, we are increasingly pursuing opportunities for students to pursue joint degree programs. Indeed, Stanford offers multiple opportunities for its MD students to become proficient in an area of basic science or some other important discipline (public policy, public health, economics, business, etc.) and for its PhD students to become more knowledgeable about clinical medicine (e.g., the recently introduced "Masters in Medicine" degree). Similarly, medical schools vary widely in their focus on research as well as in the sources of their research support. The delineation used by US News & World Reports (USNWR) -- about which I won't comment further in this discussion - divides schools into "research-intensive" or "primary care." Stanford clearly falls into the research-intensive category because of the focus of our faculty, the amount of total NIH funding and the amount of competitive funding per faculty member (for which we rank at the top). A strong research focus is not inconsistent with excellence in patient care -- which I believe our faculty does in an outstanding manner -- but is related to the fact that most of our faculty have some (or all) of their time dedicated to research. Clearly this has an impact on the students we educate and on our goal of training leaders and individuals who will pursue careers as physician-scientists and clinician-scholars. Teaching hospitals are the second key component of an academic medical center. These include ambulatory services (which are increasingly the focus of clinical care) as well as hospital-based facilities. In many cases the teaching hospital includes all services (including pediatrics) whereas in some institutions there are separate, sometimes freestanding children's hospitals (e.g., Children's Hospital of Philadelphia, Cincinnati Children's Hospital) or "women and children's hospitals." Specialty hospitals (e.g. for heart disease, orthopedics, neuroscience) have also emerged in recent years but are not part of the mainstream at this point. For a number of academic medical centers the major teaching hospital affiliates are owned by the university, even when the operate somewhat autonomously. In other settings, the hospital is independently owned and an affiliation agreement defines the relationship between the school and the hospital (e.g., Yale-New Haven Hospital is such as example). Further, while some academic medical centers are "closed facilities" (i.e., only faculty have admitting privileges), in many institutions the university hospital also functions as a community hospital. At a different end of the spectrum, the Harvard teaching hospitals are unique as a model since the major affiliates (e.g., the MGH, Brigham, Children's Hospital, Beth Israel-Deaconess, Dana Farber Cancer Center) operate autonomously, employ their faculty, manage all grants, and have an affiliation with Harvard Medical School -- even though the vast majority of the 8000 full-time faculty with Harvard Medical School appointments are in one of the affiliated hospitals. This is not a model that is likely to be replicated elsewhere but it does speak to the fact that academic medical centers have evolved in very different ways depending on whether teaching hospitals preceded the creation of the medical school or vice versa. The model at Stanford shares similarities and difference with national peers. Stanford Hospital & Clinics and the Lucile Packard Children's Hospital are owned by the University, but they operate independently under the leadership of a President and CEO, who reports to a Board of Directors. At Stanford, the hospital boards include a mixture of Stanford University trustees and non-university trustee members. However all directors require approval by the University Board of Trustees. Like a number of its peers, SHC serves as a teaching hospital (80% or more of the patients who are admitted are under the care of faculty) as well as a community hospital, serving physicians who meet hospital credentialing. We value the involvement of community physicians to our medical center community. Although LPCH admits a smaller percentage and number of cases (given the nature of pediatric practice), it also serves the needs of community pediatricians as well as Stanford faculty. Again this is a valued partnership. The School of Medicine has an affiliation agreement with SHC and LPCH that is approved by the University Trustees. The third element of an academic medical center, and of course in my opinion the most important, is the faculty. While a medical school includes basic and clinical science faculty, the major interactions in an academic medical center are between the school, teaching hospital(s) and the clinical faculty. These interactions are usually organized through a faculty or physician "practice plan." The practice plan may be separately incorporated as a "foundation" (as is the case with many of the Harvard teaching hospitals) or integrated into the teaching hospital, or it may come under the jurisdiction of the Office of the Dean. Again, there are many different models and iterations. At Stanford, all faculty are School of Medicine and University employees. That is, their official employment is with the university, they are accountable to the school leadership, all grants flow through the school, research and academic space is provided by the school, and compensation is recommended to the dean by the department chairs contingent on the approval of the Provost. However, the "clinics" where faculty practice are under the hospital's aegis, and important activities such as physician billing, collections and professional payments flow through the hospital. Professional revenues and support for other faculty activities (e.g., medical direction, program support) are transferred from the hospital to the school through a process called "funds flow" -- a topic I have addressed in previous Dean's Newsletters (see: http://deansnewsletter.stanford.edu/archive/02_22_05.html). Depending on the center, interrelations between the school, hospital and physician practice group can be a productive and effective or contentious and challenging. To a great extent this depends on two dominant factors: whether the missions between these three important entities are aligned and whether the leadership is able to work collaboratively and effectively. There is no question that teaching hospitals, medical schools and clinical faculty should share common goals -- but the degrees of emphasis and focus will vary from center to center and will delineate the overall effectiveness of the functional affiliation. At the same time, it is important to acknowledge that there are cultural and monetary differences in the way universities and businesses (including hospitals) behave and these will not uncommonly lead to differences of opinion as well as tensions -- which can be constructive and sometimes destructive. To address this complexity, a number of academic medical centers have appointed a single leader to coordinate the major elements (school, hospital and practice plan) and to also arbitrate disputes that may arise. The most common such position is that of a Vice President (or Vice Chancellor or Provost) for Medical Affairs. Stanford has had such a model in the past but during the past 5 years (the length of time I have been Dean) a different model has been used. Specifically, we have recognized that to optimize each of the entities (both hospitals and the school), the respective leaders (Dean and CEOs) would need to function collaboratively. We have in fact done so (for the most part) by sharing a common vision, strategic plan and a willingness to address difficult issues as they arise in a manner that puts Stanford Medical Center first. While many governance structures are designed to address functional leadership, at the end of the day it is the ability of institutional leaders to work cooperatively that will define institutional success. I am pleased that the SHC CEO Martha Marsh and the LPCH CEO Chris Dawes share those values and that, accordingly, our academic medical center has functioned in a collaborative and integrated manner. While there are many examples of why it is important for the components of an academic medical center to work in a collaborative and coordinated manner, a meeting of the Association of Academic Health Centers on June 27-28 provides an excellent one. At that meeting, leaders from the university, school and hospital presented a work-in-progress effort designed to re-engineer the infrastructure needed to support clinical research and, in this case, clinical trial billing. Many academic medical centers across the country are grappling with the difficulties of creating a seamless interface between medical school, hospital and clinical faculty -- a process that is confounded by a lack of unity regarding mission as well as a lack of integration between school, faculty and hospital. I am very pleased to say that our Stanford team presented how this can be done -- and were clearly the envy of the attendees at this national meeting. Put simply, this was because a committee of senior faculty, representatives from the Dean's Office, senior hospital vice presidents, and legal counsel has met for some two years to develop the SPCTRM (Stanford Packard Center for Translational Research in Medicine) program. This is a terrific example of how cooperation can solve a problem that would be simply insurmountable for any single component of an academic medical center. I want to thank in particular Dr. Steve Alexander, Professor of Pediatrics and Director of SPCTRM; Nick Gaich, Chief Operating Officer of SPCTRM; Dr. Harry Greenberg, Senior Associate Dean for Research; David Harray, Vice President, SHC; and Ann James, Office of the General Counsel. Academic medical centers will surely continue to evolve during the years and decades ahead. Likely there will be continued internal reorganizations, driven by program developments or requirements. External factors, particularly the status of the health care system, will also have a major impact on the size, complexity and functions of academic medical centers. Given predictable change, it is important that academic medical centers continuously re-examine their mission and resources. At Stanford, our unifying mission remains "Translating Discoveries," while fully realizing our success will require focus, communication, commitment and collaboration. Future success is our only option. | My professional career has been dedicated to treating serious disease -- both as an investigator and as a physician. As Dean I have also been very concerned about the healthcare system in this country -- or the lack thereof. At the same time, in my personal life I have focused a lot of personal energy on health and the prevention of disease. As some of you know I have been a strong proponent of exercise, weight control and diet as key components to controlling personal risk -- whether acquired or inherited. And while we all recognize that serious disease can strike regardless of one's commitment to health, it is also a safe assumption that personal lifestyle and choice can have a big impact on reducing the likelihood of a host of human disorders. Ironically, as one surveys the major diseases impacting human health, nearly all are the interaction of single or complex genetic traits with the environment and personal lifestyle choices. While there are some disorders we can simply not attenuate or prevent, many others will respond to lifestyle change. This is graphically illustrated by the epidemic of obesity that is sweeping the USA and many parts of the world and that carries enormous co-morbidity that can impact the health and longevity of generations to come. It is estimated that obesity has doubled in children 6-11 years of age and tripled in 12-19 year olds since the late 1970s. Much of this increase results from dietary choices largely associated with the marketing and availability of high carbohydrate, fat and calorie drinks and foods. In fact nearly 30 % of the calories consumed by children are from sweets and soft drinks and overweight children may consume as many as 1200-2000 calories per day from soft drinks alone. Fast foods and high volume sodas are particularly noteworthy. And this is big business, as evidenced by the many hundreds of millions of dollars spent on advertisements to children for various high caloric foods! This has prompted some physicians and public health officials to question whether legal action focusing on schools, the community and medical insurance is necessary to control this obesity. A Health Policy Report in the June 15th issue of the New England Journal of Medicine (Volume 354:2601-2608) entitled "Obesity -- The Frontier of Public Health Law" by Mello, MM, Studdert, DM and Brennan, TA address this important issue. In many ways this situation is analogous to the debate that took place over smoking during the past several decades. While there are many understandable concerns about regulating lifestyle, there can be no question that individual choices have tremendous societal and economic impacts as well as significant personal consequences.. The factors governing obesity in children, adolescents and adults are but one example. The purpose of this brief commentary is simply to underscore the importance of pursuing personal health. It is all too easy to let simple interventions like exercise and diet, for example, be compromised or ignored. All that said, I do feel compelled to confess to those who may have seen me with my arm in a sling and a notably bruised face that I did have an injury during an early morning run on July 11th when I missed a curb and went crashing to the ground. So, I also acknowledge that exercise can be associated with injury as well (as I have learned many times in my own athletic career), but I would still maintain that the benefits far outweigh the risks. Indeed attention to simple health interventions can go a long way to promoting one's well being and to reducing the need for healthcare (injuries aside). Certainly this is an issue that deserves everyone's consideration and hopefully personal implementation. | On July 7th US News & World Reports (USNWR) published their annual ranking of "Best Hospitals" in the USA. Too much attention is given to these rankings but I do confess that I have been personally somewhat obsessed by the methodological deficiencies in some of these rankings, particularly schools of medicine, that favor size over quality. While Stanford School of Medicine was ranked # 7 in the nation in the April reporting on graduate schools, this scoring is impacted significantly by the total amount of NIH support -- in which Stanford can never truly lead given its small size compared to peer schools (see http://deansnewsletter.stanford.edu/archive/04_03_06.html#2). But that is an issue for another day. Hospital rankings are also impacted by size, available services and reputation among other factors. In the new ranking Stanford Hospital & Clinics as well as the Lucile Packard Children's Hospital were separately ranked as #13. Of course we think they should both be higher, but given the small size of SHC and the relative youth of LPCH compared to peers, these rankings are quite admirable. Congratulations to both SHC and LPCH. | Dr. Ben Barres Offers an Important Perspective on Behalf of Women in Science As a number of you likely know by now, Dr. Ben Barres, Professor of Neurobiology and of Developmental Biology and of Neurology and Neurological Sciences, wrote an informative and compelling commentary in the latest issue of Nature 442, 133-136(13 July 2006). I want to complement Dr. Barres for his personal courage in writing this important article and for his steadfast advocacy on important issues. Change only occurs when individuals speak up and lend their voice and reputation to important issues. Dr. Barres has done just that and I am proud of his efforts and of his work as a faculty member at Stanford. Because I also believe that Dr. Barres' perspective is so important I have his permission to print his commentary in this Newsletter in case you missed the original publication. Here it is:
References
| On Friday morning, July 14th, Dr. Harry Greenberg, Senior Associate Dean for Research, convened a planning retreat of the program leaders for Stanford's Clinical and Translational Award application that will be submitted in January 2007. As noted on the NIH website, "the Clinical and Translational Science Awards (CTSAs) program will create a definable academic home for the discipline of clinical and translational science. Specifically, this program will encourage the development of novel methods and approaches to clinical and translational research, enhance informatics and technology resources, and improve training and mentoring to ensure that new investigators can navigate the increasingly complex research system. To create this "home," the program allows for local flexibility so that each institution can determine whether to establish a center, department, or institute in clinical and translational science." Dr. Greenberg underscored that the goals of the CTSA are to educate, innovate and implement. This includes: 1) developing a cadre of well-trained multi- and inter-disciplinary investigators and research teams; 2) creating an incubator for innovative research tools and information technologies; and 3) synergizing multi-disciplinary and interdisciplinary clinical and translational research and researchers to catalyze the application of new knowledge and techniques to clinical practice at the front lines of patient care. While the timeline for producing the final grant is short, we have actually been working on the fundamental components for this type of effort during the past 5 years as we have implemented our Strategic Plan, Translating Discoveries. Indeed, the transformational changes we have made in education and training through the New Stanford Curriculum, which focuses on educating future physician scholars and investigators and which offers Scholarly Concentrations in clinical and translational research, offer a firm underpinning for our CTSA application. Coupled with this are our related education programs for graduate students in clinical and translational research and medicine (i.e., the Masters in Medicine Program) and evolving programs that will enable clinical fellows to pursue graduate training en route to becoming physician-scientists (i.e., the Advanced Residency Training at Stanford [ARTS] program). Moreover, the fundamental underpinning provided by BioX to foster innovative interdisciplinary research together with the broad interdisciplinary efforts of our five Stanford Institutes of Medicine and the Strategic Centers has already created unique opportunities for clinical and translational research. To further enhance these efforts, programs like SPCTRM and STRIDE (Stanford Translational Research Integrated Data Environment) are being designed to provide the fundamental supports to foster clinical research along with data management, analysis, etc. Thus, in a number of ways, the new CTSA opportunity comes at a time when Stanford has already made a number of important transformational changes to enhance clinical and translational education and research. It provides an opportunity to further consolidate and refine the many new programs we have already put into place. That said, we also recognize that such large and overarching grant applications necessitate a tremendous amount of work and effort from many faculty and staff, many of whom are already extremely busy. In addition, given the current funding climate at the NIH, these applications are high risk. Despite our many accomplishments, we must perform at the very highest level if we hope to be approved and funded. It is imperative that those participating in the CTSA do the very best job they can and, because of its broad implications, that as many faculty and staff throughout the school as possible be engaged -- and that there be opportunities for specifically interested faculty to participate. Like all such grants, there are specific components that must be addressed. The goal of the July 14th retreat was to have each of the specific program leaders give an update of their planning efforts. Each area is in some way specified by the RFA (Request for Application), and each working group already has multiple faculty who are becoming engaged in the planning process. The 10 major programs areas and working groups for the CTSA grant are as follows:
* Denotes the Working Group Chair Dr. Greenberg will be serving as the Principal Investigator for the CTSA, and he will be joined by three Co-PIs: Drs. Charles Prober, Phil Lavori and Brandy Sikic. If you have any questions, concerns or interests, please feel free to contact any of these individuals or any of the working group leaders noted above. While there is a tremendous amount to do in the next several months, we are building from an excellent and already transformational base and I feel confident that a great proposal will result. But everyone's help and support will be needed to make this a reality. | As has been my practice in past years, the Dean's Newsletter will be not be published on the usual bi-weekly schedule in July and August. However, should important events arise between issues I will make sure you are aware of them. In addition, at the end of July through the third week of August I will be on a "mini-sabbatical" that will include some vacation time but also some time to work on a new book. Rest assured - I promise not to report on either of these topics in my subsequent Dean's Newsletters! The bi-weekly publication schedule will resume in September. |
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Microsoft Word version: DeanNewsJuly06.doc | |
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