1999 ASN Presidential Address (2000)

On behalf of the Council of the American Society of Nephrology (ASN), I welcome you to Miami Beach and the 32nd annual meeting of the Society, the last meeting of this millennium. I have been honored to serve as President of your Society over the past year and have felt a special responsibility, because I represent the first member of the Council, and thus the presidency, elected by peers. Before I go further I would like to express my debt of gratitude to the ASN staff led by its executive director, Sherri Mara, and to my assistant, Margaret Marksthaler. Without their intense, tireless efforts, this meeting would simply not have happened. Then I would like to recognize the 1999 Program Committee (Table 1). The dazzling science, both clinical and basic, that is being presented is largely the result of their incredible hard work and effort. Their chair, Tom Coffman, has done an absolutely fabulous job.Table 1: 1999 American Society of Nephrology Program CommitteeaWhen considering the awesome task of saying something meaningful to your respected colleagues and esteemed scientists, I took solace in the words of Abraham Lincoln in the Gettysburg Address when he said, “The world will little note nor long remember what we say here.” He went on to say though that he hoped that people would remember what transpired at Gettysburg. I hope the same is true of the 1999 American Society of Nephrology Meeting. As one reflects on the upcoming century and looks back over the last one, the advances in our discipline have been truly remarkable. When I think of nephrology as it was 35 years ago when I began, there are stark contrasts with today. The standard hemodialysis procedure used two dialyzers for different patients and the same dialysate bath. Obviously, this was before there was any knowledge of infectious diseases such as hepatitis B, hepatitis C, and HIV. The standard hematocrit for patients on dialysis was in the low 20s. Many of the symptoms we attributed to uremia have been eliminated by the startling discovery, development, and routine use of erythropoietin. There were no computers. When scientific manuscripts were typed, carbon paper was used and if a mistake was made, retyping was required. Molecular biology and genetics were considered subjects of little clinical relevance, but now the genes have been identified and cloned for polycystic kidney disease and a growing array of renal disorders. This puts the pathophysiology of disease at a molecular level with obvious exciting therapeutic implications. Renal transplantation when it worked was considered a miracle; now, when it does not, there is much soul searching. There were intense debates about whether diabetic patients with end-stage renal failure (ESRF) should even be offered renal replacement therapy with the predominant feeling that they should not. There were committees that decided who would live and who would die for want of available ESRF treatment resources. Rationing of care was explicit. Such factors as divorce, diabetes, and lupus were all points against you. To put medical progress in perspective, one need only look at the marked decrease in the past 40 years of age-adjusted mortality in the United States. Although most of our patients still die of cardiovascular disease, the drop in death rates from these causes has plummeted markedly, in my view largely due to advances in medical care including importantly the treatment of hypertension. Thus, as we look ahead, the members of the American Society of Nephrology and the entire nephrology community can be proud of their scientific and professional achievements on behalf of the patients we all serve. The future scientifically is simply dazzling and the possibilities are unlimited. Yet as I look ahead, my enthusiasm is somewhat muted by two problems potentially immense in their implications, which are as yet unsolved and perhaps even unrecognized by many. These are the increasing role of industry and economics in nephrology and the diminishing pool of physician-scientists. Let me address them now. Largely because of economic considerations, there has been a marked change in the delivery of health care. Under the rubric of saving money and “population medicine,” the landscape has changed. Physicians are no longer considered by the public and perhaps even by themselves as advocates for their own patients. The governor of my state of Oregon, himself a physician, stated publicly that the “Hippocratic Oath was outdated for the 20th century.” He used this as a justification for the Oregon Health Plan of expanding Medicaid eligibility to more individuals in the population by the technique of reducing services to sick patients so that the program would be budget neutral. A ranked priority list of diagnoses and treatments despite a lack of factual basis was created with these coverage decisions to be explained to the patients by the doctor. Patients were rapidly transferred into managed care arrangements even though they were a Medicaid population with the typical health profile of that population. A Harris poll shows what these patients thought versus what is written in the managed care satisfaction surveys you read in the marketing propaganda (Figure 1). Few in the profession stood up against the questionable ethics of these marked changes in the doctor-patient relationship. The Oregon program is a financial disaster, as judged even by its most ardent supporters with large amounts of new money required to cover the bureaucracy and even the basic medical services for this population. More importantly, the program has further served to discriminate against the fastest growing minority group with whom we as nephrologists interact, namely, the seriously ill. In my view, the profession may be close to giving up its birthright, which is the traditional doctor-patient relationship. Everything now seems to be driven by the unproven idea and perception that the primary goal of the health care enterprise is to save money by health maintenance. The sick are considered failures. Physicians, to many, are little more than interchangeable technicians whose services are bought and traded like other commodities.Figure 1.: Experiences of low-income individuals in managed care arrangements. Managed care members (▪) expressed lower levels of satisfaction than those using fee-for-service (□). Data are from The Commonwealth Fund Managed Care Survey, 1994 (Louis Harris & Associates, Inc.).In nephrology, the industrialization and incorporation of the practice of medicine has been dramatic. Wall Street, not Main Street, controls health care. Inevitable forces that flow from this process have rapidly changed the face of the profession. Firms with anonymous shareholders are interested in the price per share, not necessarily the long-term health of the company or health care enterprise. To quote the Nobel economist Milton Friedman (1), “Few trends could so thoroughly undermine the very foundations of our free society as the acceptance by corporate officials of a social responsibility other than to make as much money for their stockholders as possible.” In some cases, the share price is more important than the current profit and loss reports. In other words, the perception of value and long-term commitment is more important than the actual product or service that is provided. In my view, the profession has been complicit and silent in this massive shift that has taken place in the past 10 years. Academic and not-for-profit health centers are facing financial dilemmas when they try to carry out their missions. A way to solve this problem is to partner with industry. Industry has and can achieve efficiencies by integrating products, services, information systems, and analysis of outcomes. However, the dimensions of these partnerships, while providing short-term financial gain, may be a Faustian bargain with long-term unintended consequences on research, education, and patient care. In nephrology, many individual practitioners, academic centers, and nonprofit hospitals have sold their operations to companies publicly traded on Wall Street. Figure 2 shows the extent of that transfer in the dialysis industry over a short period of time. In the United States, dialysis units are being acquired at a cost of $40,000 to $60,000 per patient. If the share price on Wall Street drops or when some other challenge to reimbursement takes place, will the industry stay engaged or pull out, mimicking the savings and loan debacle? This would leave the responsibility for the patients to the government, public institutions, or individual physicians. Why are Wall Street and the dialysis providers interested in this enterprise in which capitated reimbursements dating back to the 1970s remain virtually unchanged? They are interested because of the opportunities to exploit advantages in the delivery of pharmaceuticals, to gain access to international markets, and to sell other products, including dialyzers, equipment, and nurse/technician services. After the consolidation phase is over, I believe that the dialysis providers, to stay in business, will need to control their major variable cost. This relates to physicians and their behavior. Thus, the ethical boundaries and realities of industry-nephrology relationships have become blurred. It should be emphasized that these tensions occur within the academic centers as well as the private sector.Figure 2.: U.S. dialysis patient consolidation. Consolidation is expected to rise at a rapid rate.As an illustration of the influence of industry on physician behavior, let me use the simple example of erythropoietin, which has changed the lives and health of so many of our patients. Experience says that the way erythropoietin is reimbursed by the federal government drives the use patterns, rather than vice-versa. When it was less profitable for the providers to use more erythropoietin, the dosages were low despite suboptimal hematocrit levels. When it became profitable due to changes in the reimbursement policy to use more erythropoietin, increasing doses followed quickly. This was prescribing based not on the best medical practice, but on the reimbursement policy. In recent years, the profit margin of most dialysis units has depended largely on the negotiated cost for drugs, such as erythropoietin and, to a lesser extent, iron and vitamin D products, compared with the charges and reimbursement of these medications paid by insurers, patients, and the federal government. One could ask rhetorically: Since it is widely accepted that subcutaneous lower dose erythropoietin is equivalent to IV erythropoietin, why isn't this dosing route used for everyone? Why doesn't the government as the major payer for erythropoietin negotiate the price directly with the manufacturer? Since 1989, under regulations enacted by Congress as proposed by Congressman Pete Stark of California, there has been a ban on physicians referring patients to entities such as clinical laboratories in which physicians or their family members have an investment. Recent modifications to this legislation have extended that ban to a variety of designated health services for Medicare patients. Dialysis units are a specific, and in my view, logical exception under the Stark regulations. However, there has been increasing scrutiny by the Office of the Inspector General to determine whether this exception is being used to enhance physician compensation by tying the unit's medical director function to the volume of patients provided to a dialysis facility. In other words, are there payment pricing schemes being used via the Stark II exemption tied to the numbers of dialysis patients referred? To the extent that this is true, medical ethics and the law are seriously compromised. The precise job description of dialysis unit medical directors should be explicit and compensated reasonably but not excessively. There must also be accountability. A Renal Physicians Association (RPA)/ASN joint committee, chaired by George Aronoff, is working to define standards of practice in this area. Other major areas in which industry/nephrology relationships are particularly important are in professional education and research. It is clear that a well-educated profession, both in the content of nephrology as it evolves and in its application to specific patient problems, is in the best interests of both industry and the profession and, in particular, the patients we serve. How this education should be carried out is a matter of some debate and controversy. There are established guidelines for sponsorship of professional education activities from the American Medical Association as well as other professional societies mandating an arms-length relationship between sponsors of an educational event and the educational provider. Undermining this arms-length relationship destroys the credibility of the educational activity and is a threat to the integrity of the profession. There obviously is a legitimate need for industry to be able to display its products and advantages to physicians. On the other hand, excessive and unbalanced marketing can erode the trust between patients and doctors. All physicians, nephrologists included, believe that they themselves are beyond the influence of such marketing techniques; however, the objective data say otherwise. How can we as a profession and a professional society fulfill our obligation for balanced educational material and, most importantly, the processes of coming to unbiased clinical decisions in such a competitive milieu? The answers are not easy because there is a public demanding reassurance of professional competency by continuing education and no obvious funding source aside from industry partners. The following information should be considered by nephrologists when attending satellite educational activities at this meeting. All of the educational symposia in the evening at this meeting are CME-approved, and the speakers were approved by the ASN President for balance; however, they were planned by industry. Without making value judgments, they should be viewed critically by the audience. 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