ARTHRITIS & RHEUMATISM Vol. 52, No. 2, February 2005, pp 395–401 DOI 10.1002/art.20865 © 2005, American College of Rheumatology ACR PRESIDENTIAL ADDRESS Living in a Different World David Wofsy There are moments in a lifetime that would once have seemed so unimaginable that they don’t seem real when they arrive. I am having one of those moments today. It seems fitting, therefore, to begin with a brief personal story directed at those of you who are just starting out in your careers. In 1980, in my first year as an instructor, my division chief called me in to discuss my future. The tone of the meeting was friendly, but the message was not pleasant. He began by saying: “I think you know that you do not have a future at UCSF.” I suppose that there are many reasons to recall such a story at a time like this, but I mention it to you today primarily to point out that most of us do not know exactly where we are going when we start our professional journey. So don’t look at those of us who happen at the moment to be in positions of prominence and think that it will not someday be you. We are you, displaced only very slightly in the grand scheme of time. An interesting career—an interesting life—can be frighteningly like a roller coaster. Just keep in mind that the low points are an integral part of the ride. Without them, the exhilaration of the entire experience would be diminished. In preparing for this talk, I reviewed the addresses of my presidential predecessors. Not surprisingly, the themes of these addresses are quite diverse and some have recurred over time, but one topic has escaped attention. Through 70 years of presidential addresses, there has been almost complete silence on the topic of our delicate relationship with the pharmaceutical industry. A few brief references exist, but they typically are couched in self-congratulatory comments about our high ethical standards. It is past time to address this subject in greater depth. The topic is simply too important, and the relationships too pervasive, to ignore. Let me begin by emphasizing that it is not my intent to critique the pharmaceutical industry. Pharmaceutical and biotechnology companies have a welldefined and important role in society, and they have many critics. Rather, I want to focus on what it means for a society of health professionals to depend so heavily upon their largesse. First, some facts are in order— about the ACR, about the pharmaceutical industry, and about me. Like many of you in the audience, I have a conflict of interest when it comes to this topic or, shall I say, several conflicts of interest. Perhaps that is one of the reasons we remain silent. So I should not discuss this topic without providing some personal disclosures. I spend most of my time these days conducting clinical trials. Much of this work is supported by industry. In the course of developing these trials, I have consulted with numerous pharmaceutical and biotech companies, including, in recent years, Bristol-Myers Squibb, Amgen, Genentech, IDEC/Biogen, Serono, Protein Design Labs, Scios, DNAX, TolerRx, and Vasogen. At the University of California, San Francisco (UCSF), I direct the rheumatology fellowship training program, which has, at times, received partial support for a fellow’s salary from Amgen. I also co-chair the UCSF rheumatology board review course that is supported largely through industry sponsorship. This year, the principal sponsors were Abbott, Centocor, and Wyeth/Amgen. I am providing these disclosures in detail because I want to make it absolutely clear that I need look no further than myself to see a problem, and because I think that my own relationships are illustrative of the kinds of choices we all face in trying to determine how to function effectively and ethically in a complex world. And it is not just a complex world in which we rheumatologists function; it is a very different world than existed even 6 years ago (Figure 1). In 1998, the unchallenged standard of care for rheumatoid arthritis Presented at the 68th Annual Scientific Meeting of the American College of Rheumatology, October 20, 2004. David Wofsy, MD: University of California, San Francisco and VA Medical Center, San Francisco, California: President, American College of Rheumatology, 2003–2004. Address correspondence and reprint requests to David Wofsy, MD, Arthritis/Immunology Unit (111R), VA Medical Center, 4150 Clement Street, San Francisco, CA 94121. E-mail: [email protected] Submitted for publication October 29, 2004; accepted November 4, 2004. 395 396 WOFSY Figure 1. Gross annual sales of antirheumatic prescription drugs in billions of dollars (data from http:// www.imshealth.com). MTX ⫽ methotrexate. was methotrexate, with gross annual sales, across all indications, of $141 million. The highest selling NSAID was naproxen, with $490 million in prescription sales. Since then, there have emerged five billion-dollar drugs in rheumatology that have been the focus of the most aggressive advertising campaigns this side of Cialis. If anyone ever doubted the magnitude of the stakes involved in this area, we now can put a number on it. During the 24 hours following the withdrawal of Vioxx, the value of Merck stock declined by $26 billion. These drugs not only have changed the stakes for the companies that work in our field but, not coincidentally, they have drastically changed the opportunities and hazards for the ACR. I will only briefly mention the opportunities, which we discuss often and which are well known to all of you, and then I will focus on how we are confronting the hazards. Increased support from industry has enabled us to substantially expand programs and services for members without a substantial increase in dues. Since 1998, our annual budget has increased by 75%, while dues have increased only 6%. The expanded programs include, for example, enhanced educational offerings at the annual meeting and elsewhere, practice management seminars, scholarships for trainees to attend our meetings, and major new initiatives to provide assistance to rheumatologists at the local level. We were also able to establish the Industry Roundtable (IRT) as a means of substantially fortifying the Research and Education Foundation (REF). The IRT is, in effect, a new kind of business relationship between the ACR and industry. In exchange for a fee of several hundred thousand dollars per year that goes directly to the REF, companies receive several benefits, including the opportunity to present a symposium during one of the evenings of the ACR meeting, preferred locations in the exhibit hall, and a yearly meeting with ACR leadership. I will not take time today to discuss the pros and cons of the decision in 1998 to establish the IRT, but I do want you to know one of the important outcomes. Throughout the decade of the 1990s, the number of trainees in rheumatology had fallen far short of the number required just to replace the current workforce. The first goal of the REF, therefore, was to reverse this trend and increase the number of trainees from approximately 115 per year to over 160 per year. This ambitious goal—an increase of almost 40%—was achieved in 2002, exceeded in 2003, and has been exceeded again this year. As a result, for the first time in a decade, the number of people entering rheumatology is more than sufficient to replace the anticipated loss from retirement in the years immediately ahead. This good news serves our members in practice, some of whom seek partners and some of whom seek successors in their practices. It serves our members in academic life by enriching their environment and assuring the viability of their programs. And, of course, it serves people with rheumatic diseases. In citing this achievement, it is important to acknowledge ACR PRESIDENTIAL ADDRESS 397 Figure 2. Major sources of income for the American College of Rheumatology. In A, the Journals segment includes income from advertising and the Meetings segment includes fees from exhibitors. If these sources of income are shifted to the Pharmaceutical segment as depicted in B, this category becomes the single greatest source of support for the ACR. that many factors have contributed to this change in our field, but it would be a mistake not to recognize the important role of the REF and to sincerely thank those who have made this happen: the members of the IRT and the leaders of the REF, including, in particular, Dan Wallace, Stan Cohen, Joe Golbus, Mike Weisman, and Connie Herndon. So what is the extent of the financial dependence on industry that has enabled us to do these things, and what are the consequences? The ACR derives support from 5 major sources (Figure 2A). The least of these sources is membership dues, which comprise 10% of our income. Interest on our investments comes to 13%, and 17% comes from our journals. The lion’s share, roughly 40%, comes from income generated through our educational programs—in particular, the annual meeting. And the remainder, 20%, comes from industry, primarily in the form of sponsorships for our meetings. This number is actually deceptively low, however, because there are additional industry contributions in the other categories. For example, the annual meeting income includes exhibit hall fees, and the journal income includes advertising. If these numbers are shifted from the other categories to the industry category, industry support actually becomes our single greatest source of income at 34% (Figure 2B), and this number does not include the REF, which currently derives over 80% of its income from industry. With this much money on the table, we have an obligation to be clear about what is for sale and what is not for sale (Table 1). We sell advertising space in our journals. We sell sponsorships and exhibit space at our meetings. We sell the right to conduct an evening symposium during the annual meeting. And we accept donations to the REF from anyone who chooses to support its programs. But there are things that we cannot sell. We cannot sell our leadership, our young, our political principles, or our silence. I would like to 398 WOFSY Table 1. What is for sale and what is not for sale For sale Not for sale Advertising space in journals Meeting sponsorships Exhibit space at meetings Symposium at the annual meeting Leadership Trainees Political principles Silence comment briefly on each of these, because they are not hypothetical concerns. All of them have been issues during my year as President. Expressions of concern about potential conflicts of interest for ACR leaders are not new, but they have certainly increased as the opportunities and temptations have increased. All of us who have been involved in ACR leadership in recent years are aware that rheumatology in general, and our leaders in particular, are on the radar screen in a way that just wasn’t true previously. From the time involvement with ACR begins, potential leaders are the subject of steadily increasing interest from industry based on the flattering, but somewhat circular, notion that we are thought leaders. Did we rise in the ACR because we were already thought leaders? Did we suddenly become thought leaders by virtue of our positions in ACR? Or have we been anointed by those who might profit from a connection to thought leaders? We each face similar questions in our own communities, and we each have a responsibility to think carefully about our answers. But there is no denying that the high visibility of ACR officers makes this a particularly important issue for them. To safeguard against potential problems in this area, this year the ACR adopted a formal conflict of interest policy for the President and President-Elect, distinct from, and much more restrictive than, the ethics guidelines that apply to all members. I want to acknowledge the extraordinary work of Paul Romain, Chair of the Ethics Committee, who worked tirelessly on this and other important matters during the past year. The Board subsequently established additional safeguards that extend beyond the President and President-Elect and apply to members of the ACR and REF Boards, the editors of our journals, and selected committee chairs. We cannot allow our trainees to be for sale. As the ACR President and as director of a rheumatology fellowship program, let me tell you in no uncertain terms that the pharmaceutical industry is quite openly more interested in our trainees than in our leaders. These are the prescribers of the future, and the people whose habits are not yet set, either in their practice patterns or in their relations with industry. I am not suggesting that trainees are not capable of making their own decisions about these relationships, just as the rest of us do. However, we should not make that decision for them by engaging in programs that obligate them in any way. Without an open discussion of the merits, we have gradually moved into an era where everything a trainee does may be attached to a pharmaceutical company— from salary support for their fellowship position, to sponsored lectures at fancy restaurants, to travel to ACR meetings, to support for their research. In some instances, this practice has gone so far that, in exchange for salary support, pharmaceutical companies design curricula, assign mentors, and provide the databases and the goals for research projects. We, the program directors, derive the financial benefit; the fellows assume the inherent obligation. We must not allow the next generation of rheumatologists to become the medical equivalent of stock cars, with corporate labels for everything they do. The ACR can and should play a role in changing this dynamic. Accordingly, a task force headed by pastPresident Michael Weinblatt recommended that the ACR not enter into sole-supporter initiatives with industry for programs designed for trainees. To achieve this goal, the task force recommended soliciting support from multiple companies to contribute to a new “ACR Fellows Education Fund” that would support all of the major fellowship-related programs of the ACR. The task force also recommended that, to further demonstrate its sense of the importance of this issue, the ACR and REF should become substantial contributors to the fund. I support this initiative, but I do not think that it goes far enough. We should also ask the training programs themselves to demonstrate their commitment to this concept, in an effort to make the program completely independent of industry support. What exactly do I mean by suggesting that the training programs should contribute? It is often pointed out to me that some programs have the resources to send fellows to meetings but others do not, and that the financially fortunate programs should be careful about preaching from a position of privilege. That is a point well-taken, so today I am prepared to put my money where my mouth is. On behalf of UCSF, I pledge to contribute to the concept of the ACR Fellows Education Fund by foregoing this resource and by using our own existing funds to support our fellows’ participation. I call on other programs with training grants or other resources to do the same so that, together, we leave absolutely no doubt about the sincerity of our commitment to the independence of our trainees. ACR PRESIDENTIAL ADDRESS The next topic has been at the heart of much activity this year and requires some explanation. When the stakes are high for our supporters in industry, there may be adverse consequences when we choose an independent path. Let me be specific. We all know that the advent of the era of biologic therapies has changed the landscape with respect to reimbursement. There have been new opportunities for compensation, and new threats to compensation. In this environment, the ACR had to make judgments about what we stood for, what we would fight for, and how we could win. Our political position was based on three fundamental principles that we thought were winnable: 1) that rheumatologists should be compensated appropriately for their cognitive skills and for their time, 2) that rheumatologists should receive equal pay for equal work, particularly in reference to oncologists and infusion therapies, and 3) that rheumatologists should be compensated for the work they do and not for the drugs they choose. I need not tell this audience that these were controversial positions. In particular, they were not shared by some of our members and by some of the companies who stood to profit from maintaining the status quo. When it became clear that the ACR position did not align with their corporate interests, some in industry made a concerted effort to discredit us by proclaiming, among other things, that the ACR is dominated by researchers who don’t care if our members in practice make money. These attempts to split us politically involved support for the development of a separate national organization of rheumatologists to advocate its own political agenda. I do not question the right of pharmaceutical companies to advocate for their interests or the rights of some ACR members to disagree with the ACR position and pursue a different course. However, I do feel strongly that these activities undermine our ability to advocate effectively on behalf of our members. As one of the smallest subspecialties, we depend heavily for our political clout on the unity that we have been able to maintain—among clinicians and researchers, physicians and allied health professionals, internists and pediatricians. Threats to this unity strike at the core of our strength. The outcome of this story is important. Last month, the Centers for Medicare and Medicaid Services adopted one of the key principles for which we have been fighting—equal compensation for complex infusion therapy. This is an extraordinary victory against substantial odds, and it is a credit to the vision, hard work, and political savvy of Mark Andrejeski, Teresa Fitzgerald Ogden, and Chris Welch of the ACR staff and especially ACR members Robert Lloyd, David Boren- 399 stein, Cody Wasner, and Betsy Tindall. In recent months, as it became possible to read the tea leaves, others have abandoned their conflicting political strategies and have sought credit for this achievement. I should be clear—this achievement involved hard work and intensive lobbying from many sources, outside the ACR as well as inside the ACR, but it would not have happened without us and without our commitment to keep our political positions independent of our financial support. There remains much to be done in this area to ensure that this important victory translates into tangible benefits for rheumatologists, which makes our unity and credibility more important now than ever. In an environment of big money and strong competing interests, the ACR has asked itself what measures can be taken to protect our independence. With this in mind, the Industry Task Force recommended, and the Board approved, a precedent-setting policy that will officially cap contributions from industry. The policy limits the amount of support the ACR shall receive from pharmaceutical and medical device companies to no more than 49% of the ACR’s overall income. In addition, the Board endorsed new policies designed to protect against disproportionate dependence on support from any single company. In citing these measures, I should assure you that we are operating well within these limits. They can, and probably should, be tighter. But for now it is the establishment of this principle that is important—that there are limits—and that we will not allow ourselves to become too dependent on any single supporter or on industry in general. To my knowledge, this is an unprecedented step for a subspecialty society to take, but one that I expect will serve us well and will be copied by others. Finally, a few words about silence. One of the things that we have sold over the years, without ever deciding to do so, has been our silence on a whole host of issues. For example, within the past year, the most important health care legislation in a generation was passed. The politics of this legislation were complex, and there are differing opinions within our own organization about its merits. The ACR supported this legislation, because there was much in it that benefited rheumatologists and for which the College had fought. But there was also no mistaking that the big winner was the pharmaceutical industry, which was granted protection against any attempt by government to negotiate prices. We were silent on this issue. Subsequently, a national debate arose regarding access to low-cost drugs from Canada. Again, silence. And we have been silent about a small but conspicuous handful of rheumatologists who have 400 WOFSY Figure 3. Annual percent increase in US total health expenditures and expenditures for hospital care, physician services, and outpatient prescription drugs (from http://www.hcfa.gov/stats/NHE-Proj/proj1998/tables/ tables2.htm). allowed unconstrained profits from drugs to influence their clinical judgment. The pharmaceutical industry has an understandable interest in maximizing profits for shareholders. It is, in fact, a corporate obligation that is achieved in part through the high price of drugs. That’s their business, but why are we silent on this issue? It is extraordinary to me that we can engage repeatedly in discussions of access to care as if the problem resides solely in the greedy and heartless managed care industry. The principal obstacle to access to appropriate medication is cost. And make no mistake, the high cost of medications does not just hurt patients, it hurts us. Figure 3 shows the annual percent increase in US health expenditures since rising health care costs came under sharp attack roughly a decade ago. During that decade, there has been a substantial reduction in the rate of increase of total health care expenses, hospital costs, and notably reimbursement to physicians. Alone, bucking this trend, is the cost of prescription drugs. This disparity has consequences for us. In 1999, for example, prescription drugs accounted for 44% of the rise in health care costs; during the same year, the net income of internists fell 10% (1). These are not unrelated phenomena. We have a very personal interest in controlling the cost of drugs, and we should speak out. We should speak out, first and foremost, because it is in the interest of our patients, but we should be aware that if we allow our silence to be bought, we are also hurting ourselves. Save for speaking our minds, the measures I have described today constitute small steps in the context of the current landscape. The pharmaceutical industry spends over 21 billion dollars in the US each year to influence what we think, what we teach, and what we do (2). That is more than they spend on research and development, more than is spent in this country on medical school and residency training combined (Association of American Medical Colleges: personal communication), and over $25,000 per physician. Just as the ACR is trying to determine how best to maintain its values in this environment, each of us individually has an obligation to consider whom we really serve and where we draw the line. There is a broad range of opinion within the ACR on all of the topics that I have addressed, and no doubt many who disagree strongly with me on one or more of them. I should emphasize, therefore, that I have spoken for myself this morning and not for the ACR. There is room within ACR for differences of opinion, but there should be no room for silence. I now ask your indulgence while I thank some people, beginning with my extraordinary colleagues at UCSF. Their range of talents represents the fabric of our profession. In thanking them, I seek also to illustrate the importance of the diversity and the unity within our organization. Thank you to Wally Epstein, whose influence during my residency played such an important role in my decision to enter this field and who allowed me to move so easily from student to colleague and friend. Thank you to Eph Engleman, former ACR President ACR PRESIDENTIAL ADDRESS and an ACR Gold Medalist, whose commitment to this profession, to this organization, and to generations of rheumatologists at UCSF quite literally knows no bounds. Thank you to Bill Seaman. The best decision I made in my career was the decision during my fellowship to work with Bill. Without his intellect and generosity, there is no way I would be here. Thank you to my partners in leadership at UCSF, Art Weiss and John Imboden. They are both outstanding scientists, but their success as leaders comes from the respect they have for the talents that others bring to the division. Thank you to the two superb clinicians and teachers whom all of us at UCSF try to emulate, Ken Fye and Ken Sack. It is in the nature of things that people like me who write grants and publish papers get the glory, but when our careers are over and we measure the good we have done in our lives, I will not hold a candle to the good that these two have done for their patients and their students. Thank you to Ed Yelin and Patti Katz, who contribute to UCSF what the ARHP contributes to the ACR by expanding the breadth of our activities, broadening our perspective, and reinforcing our social conscience. A special thank you to some former trainees who are responsible for virtually all of the important research that I have ever done: in particular, Nancy Carteron, Caroline Gordon, Kari Connolly, Barbara Finck, and David Daikh. Thank 401 you to those who have borne the brunt of my absences this year without a single lapse into complaint—at least not in my presence: Mary Nakamura, John Davis, Maria Dall’Era, Joann Gillis, and Laura Julian. I am so grateful for your support and understanding. I must also thank my extraordinary Board of Directors, and all the other ACR volunteers who have made this job so rewarding and enjoyable. I will sorely miss working with them and learning from them. And thank you to the entire ACR staff. Only the ACR President ever gets to really know how well we all are served by these remarkable people. I will save my thanks to family and to close friends outside UCSF for more private moments. Suffice it to say here how much I value my close friends in rheumatology. You know who you are and how much you mean to me. It has been an honor and a great privilege to represent the American College of Rheumatology this year. Thank you all very much. REFERENCES 1. Davidoff F. The heartbreak of drug pricing. Ann Intern Med 2001;134:1068–71. 2. US promotional spending on prescription drugs, 2002. CMAJ 2003;169:699.