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Presidential address: Who we are, what we do, and where we are going

1996; Elsevier BV; Volume: 23; Issue: 5 Linguagem: Inglês

10.1016/s0741-5214(96)70252-5

1097-6809

Thomas J. Fogarty,

Natural Products and Biological Research

It isn't often that one has the opportunity to publicly express debts of gratitude to those who have significantly influenced and contributed to one's career. I would like to mention several outstanding men with whom I have worked and thank them for the time, direction, and counsel they have generously given to me. In 1950 Dr. Jack Cranley, a long-time prominent member of this Society, identified me as a talented scrub technician, and through his encouragement I set forth on my career path in medicine. He made it possible for me to attend medical school by providing summer and part-time employment during my high school, pre-medical, and medical school education. My educational experience was also highlighted by medical innovators, Dr. Al Star, Dr. Charles Dotter, Dr. A. G. Morrow, and Dr. Norman E. Shumway, who provided me with direction, insight, goals, and opportunities, for which I am forever grateful. One of the prerogatives attached to the presidential office of a major society includes the freedom to choose the subject matter for the presidential address. Reflection on my part resulted in the potential for two presentations. The one I have chosen not to give deserves mention. As physicians, we have after many years of denial finally come to accept that we indeed are in a service business. Our customers are our patients, and our job is prevention, maintenance, and repair. This address marks the 49th Presidential Address, and until today none of the former presentations have focused on prevention. At the risk of eliminating our livelihood, I thought it might be appropriate to give the first Presidential Address on the Prevention of Vascular Disease. I originally chose as my topic: The Therapeutic Benefit of Red Wine Drinking on the Cardiovascular System. Overwhelming evidence is now available that documents how the ravages of atherosclerosis can be delayed by moderate daily consumption of red wine. Components within the extract obtained from the red grape skin have a salubrious effect on the cardiovascular system. It has been documented that the extract that is released from the red grape skin upon ingestion causes decreased platelet adhesiveness, increased HDL level, decreased serum lipids, and arterial wall relaxation that persists well beyond the presence of a measurable blood alcohol level.1Siemann EH Creasy LL Concentration of the phytoalexin resveratrol in wine.American Journal of Enology and Viticulture. 1992; 43: 49-52Google Scholar, 2Yao SK Ober JC Krishnaswami A et al.Endogenous nitric oxide protects against platelet aggregation and cyclic flow variations in stenosed and endothelium-injured arteries.Circulation. 1992; 86: 1302-1309Crossref PubMed Scopus (172) Google Scholar This extract also has a beneficial effect on the endothelium. These therapeutic benefits related to wine ingestion have collectively become known as “the French Paradox.”3Renaud S de Lorgeril M Wine, alcohol, platelets and the French paradox for coronary heart disease.Lancet. 1992; 339: 1523-1526Abstract PubMed Scopus (3020) Google Scholar Nitric oxide is found in high concentrations in the extract of the red grape and has been identified as one of the critical components in the resultant beneficial effect. These findings should then extrapolate to providing vascular surgeons with an excellent rationale for prescribing moderate red wine consumption for all of their patients. The author of this manuscript provides testimony that those wines bearing the Fogarty label are particularly beneficial in their antiatherogenic effect. However, despite the ever-increasing evidence extolling the positive health benefits of medicinal red wine consumption, as of this writing there is still no allowable reimbursement code for this type of counsel, nor is a prescription for red wine viewed as an acceptable drug. In addition, the FDA most certainly would have concerns about “off-label use” and appropriate dosages. Despite these obstacles to the adoption of this treatment method, as an enologist and physician I am hopeful that red wine might someday be considered a “valued drug” by the FDA. However, because I feel a responsibility to depart my presidential office leaving information and a perspective that has immediate applicability, I was forced to abandon this topic. Moving beyond that lighter medical note, I would like to address the socioeconomic and technologic changes that are occurring in the field of medicine and specifically how these changes impact our specialty. It is noteworthy that of the 48 former SVS presidents, only two have been private practitioners in the traditional sense. Although my early career and current activity is within an academic center, the major portion of my clinical experience was spent in a private practice environment. The election of a nontraditional president in this time of change indicates that our specialty, as represented by this Society, is willing to earnestly confront the issues that are influencing the way we currently practice vascular surgery. The last four decades have seen profound changes in the socioeconomic structure of medicine. Medical treatment is now considered a right, not a privilege. Demands are being placed on our medical clinicians and institutions to increase coverage while decreasing the costs for the resultant improved products and services. Currently 14% of the U.S. gross national product is committed to medical care. In an attempt to reduce this figure, managed care organizations have emerged as an insurance coverage system that significantly alters the way we practice medicine. Coalitions of hospitals, companies, and more importantly, coalitions of insurance agencies have developed into influential and powerful entities. These mega-organizations are new and unfamiliar to us, and as a specialty we are attempting to formulate a strategy to responsively interact with them. Concurrent with all these reforms, revisions, and restructuring to our environment, we have witnessed revolutionary advances in technology. In our specialty advances have occurred in the development of techniques, drugs, procedures, instruments, and improved services that are rapidly replacing our standard, conventional models. We are immersed in a technologic revolution in which altered socioeconomic forces require us now, more than ever, to question: “Who we are, what we do, and where we are going.” I will give my perspective on these important questions that face our specialty. If we respond individually, the answer is obvious and straightforward. Each of us is a surgeon who has gained additional training and expertise in the diagnosis, treatment, and management of vascular disease. When attempting to further define the question as a collective, the response becomes much more complex. Certainly, the response is not uniform. When questioning “who we are,” the answer is couched in terms of what person, or what institutional affiliation serves to characterize us. For those in traditional private practice, the name of the hospital or clinic is used as an additional identifier. That physicians identify themselves with dissimilar descriptions serves to document that they not only perceive themselves as dissimilar, but in fact, function with very different perspectives. Physicians have segregated themselves into two camps: academicians and private-practice physicians. Despite having a partnership within the same specialty, academicians and private practitioners have remained quite distinct and separate. The relationship between the two camps has historically varied from good to bad or indifferent, and in some situations, has been downright confrontational. The criticism directed at one another over the years has been somewhat consistent. It is worth reviewing the activities and relationships that have been the source of this criticism. Private practitioners viewed academicians as elitist, somewhat artificial, and perceive that they are unrealistic, do not work hard, and are therefore economically deprived. They felt this group was more concerned with academic advancement than clinical care. Teaching and research were used as mechanisms to achieve that end. The academician did not address real-world issues, but instead created artificial environments protected by the socialistic structures that academic institutions tend to foster.4Anderson M Impostors in the temple. Simon and Schuster, New York1992Google Scholar In this unrealistic environment they taught, researched, and practiced medicine while failing to recognize how little their efforts influenced the real world of medicine. There are, however, some good attributes that private practitioners recognize. Academicians are influential, scientific, altruistic, current, and good teachers. In turn, the physicians associated with teaching and academic centers consider private practitioners wealthy or economically advantaged, uninformed, late-adopters, non-scientific, and not very influential. In addition, academicians have often held the view that private practice centers were environments where financial return became the most important issue of practice. Basic research was never done in these environments. Meaningful clinical research was rarely done, as this activity was considered time-consuming and expensive and did not bring value to the bottom line. Even when clinical research was performed, it was viewed with suspicion by academic centers. Practitioners were viewed as too busy to contribute to the teaching effort. When they did contribute, their value was often considered marginal. On the plus side, private practice physicians were considered efficient, practical, pragmatic, as possessing technical talent, and as being educable. The opinions that these two groups have of one another when analyzed honestly are unkind, and when stated succinctly results in these perspectives. The university physician perceives private practitioners as individuals whose pursuit of money often results in bad judgment. The private practitioner views the university-based physician as an individual who generates useless papers and meaningless titles. In fact, there are at times and in some situations, elements of truth in the statements made by each. Both groups are functioning to fulfill their own personal agendas, and each is partially correct in their assessment that the others' activities are self-serving. Academic advancement in and of itself is not bad, and should be viewed as an admirable goal. When this goal becomes so overriding that clinical care, teaching, and research become minor objectives, balance is lost. In this unbalanced environment, if inappropriate advancement occurs, those who follow also become unbalanced. The pursuit of wealth in and of itself, likewise, is not bad or evil. An overemphasis on wealth, however, can lead to inappropriate and unnecessary procedures that result in compromised patient care. More recently, unbridled competition on the part of both groups for patients has resulted in very destructive and inappropriate activity that has further separated these groups from cooperative efforts. The question one should ask is; “Do these perceptions make any difference?” As recently as 10 years ago a lack of or a poor relationship among these groups in most circumstances had little impact on their function. In the current environment, because of changing technology and socioeconomic issues, it has become crucial to not only relate to one another but also to work closely together to benefit our profession and the patients we serve. Traditional private practitioners and those associated with training centers are going to have to alter their attitudes, approaches, and relationships to one another if they are going to continue to enjoy their past successes. This relates to the most critical issue facing all physicians, both academic and private sectors alike: the ultimate viability of our teaching centers. Universities are dealing with a lack of research funding and decreasing financial support for postgraduate education. Fiscal efficiency is required if academic institutions are to remain intact as clinical centers. This effort should not be the sole responsibility of the academic community alone. It should be recognized that fiscally experienced private practitioners can have a vital role in this endeavor and should be involved in the joint process. As well, the Lifeline Foundation, as the research arm of the Society for Vascular Surgery and the International Society for Cardiovascular Surgery, North American Chapter, has been chartered to address the key issues of research and the education of young specialists in vascular surgery. We are obligated to support its efforts. If these actions are not initiated, our educational institutions will continue to be compromised or function at a low level, and the future of American medicine will be jeopardized. “What we do” may be answered simply: we are surgeons who operate on the vascular system, and we have been taught to do this by cutting and sewing. The university's traditional role is to provide direction, develop new procedures, and advance technology, and then to educate and promulgate this information to students, trainees, and those in active practice. To accomplish this goal totally independent of the private practitioner is difficult in some situations and is virtually impossible under certain circumstances. For example, many common general surgical procedures such as hernia repair and cholecystectomy are infrequently performed in many academic centers. Academic surgeons are unlikely to develop improvements related to procedures that they rarely perform. In fact, less-invasive general surgery was initiated and developed primarily by private-practice physicians.5Ger R Monroe R Duviver R et al.Management of indirect inguinal hernias by a laparoscopic closure of the head of the sac.Am J Surg. 1990; 159: 370-373Abstract Full Text PDF PubMed Scopus (212) Google Scholar, 6Reddick EJ Olsen DO Laparoscopic laser cholecystectomy: a comparison with mini-lap cholecystectomy.Surg Endasc. 1989; 3: 131-133Crossref PubMed Scopus (716) Google Scholar In the field of vascular surgery, as previously alluded to, a close relationship between the academic community and private practitioners is also lacking. The following statistics will serve to make this point. Of all major vascular procedures performed in the United States in 1994, between 10% and 12% were carried out in the university setting. Private institutions provided the setting for approximately 88% of these major vascular procedures. A review of the official Journal of our Society for the year 1994 revealed that 85% of the scientific articles that were published originated in university environments, whereas only 15% of them came from private institutions. To say that this is an imbalance is an understatement. Contributing university groups are reporting on a small and highly select segment of patients. The largest portion of clinical material is not being reported on and is very likely not being analyzed. The criticism is obvious. Private practitioners are not contributing to the extent they could be and should be. The academic community is reporting too much on too little. Our specialty would be better served if the literature reflected a cooperative and balanced case selection offered by both groups. This requirement becomes critically important when one considers that managed care organizations will mandate outcome data on the procedures we perform. It is no longer sufficient to provide the self-proclaimed best care concept that previously served to satisfy the patient, the patient's family, and the referring physician. Contracts for patient care will be awarded on the basis of cost, outcome analysis, and the ability to negotiate. Outcome analysis can only be understood when the entire spectrum of disease is considered. Private practitioners, in general, deal with less-complex clinical cases. Academic centers traditionally treat more advanced diseases and manage patient groups that present significant technical challenges. Because of this selection process, the reported literature can often indicate higher mortality and morbidity rates than actually exist. If one were to look at outcome analysis with this biased view of case selection, what is reported will not be representative of our specialty's efforts. We must become more cohesive in assessing and reporting what we do in a uniform fashion. Additional factors should serve to unify us. Powerful unifiers are the threats common to both private practitioners and academicians. These common threats are a decrease in influence, a decrease in independence, an increase in competition from other specialists, a decrease in financial resources, and the emergence of the general practitioner as gatekeeper. If we observe the shift in the balance of influence exerted by physicians on the therapeutic decision today contrasted to 1960, we would find a most interesting and disheartening occurrence. Fig. 1 graphically illustrates this shift. In 1960 physicians made therapeutic decisions in consultation with the patient, the patient's family, and the referring physician. In 1995 we are dealing with a totally different decision model. Today players involved in influencing therapeutic decisions are the treating physician, the referring physician, insurance companies, government and regulatory agencies, industry, and hospital administration and staff. The balance has dramatically shifted. Physician input and influence has precipitously declined, and in its place we see a significant increase in the influence exerted by regulatory agencies and insurance companies in determining what we can do and how we may do it. This situation should not exist. A simple but important concept is founded in the principle that the therapeutic decision should ultimately be made at the highest level of knowledge and integrity. Those best qualified to make these decisions are physicians in the practice of medicine, caring for the individual patient. I would like to address the increasing and potentially adverse influence of government regulatory agencies. Two governmental agencies that have impacted us most profoundly are the Food and Drug Administration (FDA) and the Health Care Finance Administration (HCFA). Although there is insufficient time to address in detail the heavy influence of both organizations, I want to briefly mention how each impacts us in our daily practice of medicine. By law, the FDA has the responsibility of addressing safety and efficacy issues associated with the use of drugs and devices. This process is implemented and directed through guidelines and regulations developed by the agency. Proposed clinical protocols for investigational drugs and devices are submitted to the agency for review and approval. After protocol approvals and completion of studies, FDA panels either approve or disapprove submissions. It is obvious that the functioning of this regulatory process can significantly influence the availability of drugs and devices and the manner in which they are used. Inappropriate delays in the regulatory process can result in multiple adverse situations. Improved treatments are denied to patients and developmental costs are significantly increased when the approval process is lengthy. Regardless of the length of time that a properly structured study takes to complete, adverse effects are sometimes identified in small groups of patients. A common response of regulatory agencies when presented with this conflict is to delay decisions or to do nothing. They seek to avoid any possibility of adverse effects by these indecisive actions and instead add additional documentation requirements, which only serve to further lengthen the approval processing time. A simple retreat to erring on the side of safety has the potential of further harming the economic and health accruing benefits that may be garnered by applying new technology to medicine. It is important to recognize other areas that the FDA also influences. Three additional vital areas in need of reform are (1) the availability of biomaterials, (2) “off-label” use of drugs and devices, and (3) reimbursement for investigational devices. Recent internal government criticism directed toward “the agency” (FDA) and mounting pressure from the drug and device industry have resulted in some very positive changes. The FDA has recently recruited increasing numbers of physicians who have clinical practice backgrounds and placed them in responsible positions where they advise regarding the nature and structure of clinical trials. Dr. Kessler has undertaken a departmental reorganization aimed at eliminating delays in the approval process for new drugs and devices. Abandoning the concept of applying drug study models to device study design has resulted in more appropriate device evaluations and subsequent decreased approval times. The HCFA, under the auspices of the Department of Health and Human Services, is responsible for administering federally funded medical insurance programs. In May 1994 this agency subpoenaed over 100 hospitals for patient billing and hospital records. The subpoena was requested for the purpose of documenting those patients who had devices used or implanted that were under FDA clinical trial auspices. The agency's implication was that these procedures should not have been reimbursed for either the professional or institutional components. All documents dating back to 1984 were requested. Institutional responses varied. Some refused to cooperate, whereas others formed coalitions of hospitals and filed suit against the agency for this action. Many institutions initiated internal audits in an attempt to satisfy the subpoena. A more dramatic response chosen by several major academic centers was to terminate clinical trials in progress and suspend consideration of any new studies. I consider this latter action gutless, totally inappropriate, contrary to the academic mission, and adverse to efforts seeking to improve patient care. Fortunately, in the interim it appears that HCFA has abandoned this investigation. The real question generated by this activity relates to a socioeconomic issue: “Who should pay for investigational devices and drugs?” The answers depend on several premises and determinations, but all relate to who receives value from the new drug or device and who provides that value. There are numerous potential givers and recipients of “value.” They are patients, hospitals, insurers, manufacturers, and physicians. Historically each of these value-givers and recipients have mutually benefited through technologic advancement, and they should continue to be allowed to do so without government intrusion. In this environment where government influence is becoming more dominant, physicians have additional obligations. As treating practitioners, we should work to effect attitudinal and legislative changes that would enable the regulatory process to become more user-friendly and efficient. If the above issues go unresolved, our patients will not receive the best and most current treatment, and the United States health care industry will continue to relocate offshore for both manufacturing and clinical investigation. Where we as a specialty will go will be determined by how we respond to current changes. Socioeconomic changes require us now, more than ever, to include economics in our decision-making process when considering a therapeutic approach. We will be required to choose a therapy based both on clinical and cost effectiveness, regardless of our training, background, or clinical perspectives. In particular, emerging endovascular technologies will displace some procedures traditionally managed by our standard surgical approach. In light of this change, it is interesting and timely that less-invasive technologies offer the possibility of reducing overall cost while still optimizing clinical benefits. The unanswered questions that remain are: “How much and how soon?” Figure 2 represents my perspective on the current status and future anticipated use of endovascular alternatives used to treat vascular disease. If these forecasts prove to be accurate on the basis of even the lowest projected numbers, vascular surgeons have limited options: adopt the new technology, reject the technology and do what is left, retire, or learn another profession. Depending on one's focus, commitment, and stage in life, any of the above options may be viable for a given individual. As a specialty that serves the interest of our patients, however, it is my recommendation that we become integrally involved in the appropriate evolution of endovascular technology. We should adopt what is useful and abandon what is not. If existing technology is abandoned it will be done because it is inferior to the new technology. When we accept this fundamental concept, barriers to future technologic advances will fall. The manner in which practicing physicians become a part of this process may differ depending on the environment. In some situations, a close collaborative relationship with a radiologist or cardiologist may prove to be the most viable approach. If these cooperative relationships are not accessible or workable, the surgeon may find it necessary to pursue endovascular technology independently. If this solo direction is chosen, it should be followed with a firm commitment to devote the time, focus, and energy required to obtain the skills necessary to master these techniques. The academic community has an obligation in this process. The traditional teaching centers have spent much of their training time emphasizing the number of techniques and procedures done by their graduates. Although this is important, too little time has been allotted to the process of critical thinking and judgment. The dedication to structure, discipline, and consistent repetitive behavior that has made us proficient may prove to be our Achilles' heel. Many of us have become so structured that we have failed to recognize the potential of competing technologies. The time has come for the academic institutions to question some of their basic premises. It is quite possible that they are not the only source of all knowledge. A broader and more global perspective on changes in specialty training should be considered by university programs. It is my belief that the traditional departmental structures have outlived their usefulness. They must either adapt to accommodate new ideas or be replaced with contemporary systems. It is important to recognize that current technology has allowed us to diagnose and treat in many ways that do not involve the use of our traditional surgical approaches: cutting and sewing under direct vision. Evaluation and adoption of endovascular technology is best accomplished in an environment that is in evolution. Because multiple specialists each possess individual talents involved in the treatment process, university centers should develop groups to effectively manage disease, regardless of their specialty training. This will involve breaking down and crossing traditional departmental boundaries. It is my firm opinion that functionally and fiscally integrated groups that consist of vascular surgeons, interventional radiologists, cardiologists, and cardiac surgeons will best administer care to patients with cardiovascular disease. The concept of a team management approach for treating disease will put individuals from different specialties together to address all aspects of the disease entities we treat. To be successful with this modern treatment model, we must minimize the large fiscal differentials that now exist between the different specialties, particularly if they are all operating within the same group. In addition, we must aggressively deal with the issues of managed care. As physicians, we will be obligated to concern ourselves with contractual arrangements, for if we do not, we will not have access to the diseases we have historically treated. Consequently, we will not become skillful with the appropriate uses of new technology and services. Vascular surgeons know more about the pathology, pathophysiology, natural history, and care of patients with vascular disease than any other physician group. It must follow then that if we are going to form multispecialty associations, it is appropriate that we maintain a dominant position within that organization. If the lion and the lamb are going to lie together, it is best to be the lion. Several universities and private practice groups have already embraced this concept and have constructed multispecialty vascular centers under the direction of vascular surgical specialists. It is my belief that only those who implement this approach will become the superior training centers and maintain their fiscal viability. Although there appears to be significant uncertainty and unrest in the medical world, it is my contention that the future is optimistic. As physicians attempting to influence the future, it is important to accept that we may not be adequately prepared in all areas. In the past physicians have achieved success by effectively practicing the familiar art and science of our profession. We must now also exert our influence on the social, economic, governmental, educational, and political issues that are currently impacting the way we care for our patients. It is well to remember that patients, as consumers, will be the arbitrators and final determinants of the future character of medical care. Physicians, however, as the only individuals who are the personal and “hands-on” interface with patients, have the ultimate ability to influence their perspective. Whether we choose to exercise that influence depends on our ability to effectively communicate that we, as caring physicians, are acting in the patients' best interests. Activities and expressions that relay a contrary message must be avoided. In this time of turbulence and change, it is never more true that knowledge and wisdom are power. I believe that the Society for Vascular Surgery, along with our brother and sister societies, do possess that knowledge, wisdom, and power. I am quite confident that we as a specialty are going to do well if we choose to follow a constructive direction of dynamic change. The future is bright, the path is clear, and the responsibility is ours.