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A Survey of the Myriad Forces Changing Anatomic Pathology and Their Consequences

2008; American Medical Association; Volume: 132; Issue: 5 Linguagem: Inglês

10.5858/2008-132-735-asotmf

1543-2165

Bruce A. Friedman,

Autopsy Techniques and Outcomes

My assigned role at this conference was to identify what I considered to be the 10 major forces that are impacting anatomic pathology, and I discovered that one of my major challenges was to limit this list to 10. There is no magic associated with the number 10, and others may not agree with my selection of these forces. My major goal is to stimulate thought among the audience members about some of these forces and how they might affect pathology. So, in fact, my goal will be accomplished if you disagree with my selection and come up with your own list.While reviewing my lecture notes last night, I came up with an 11th idea about a force that was hiding in plain sight from me and that is the sharing of information about the future of anatomic pathology through blogging. I would like to briefly discuss this method of communication, using my own blog, "Lab Soft News," as a means to illustrate the possible effects of blogging on the future of pathology.I started blogging about 17 months ago almost on a kind of whim, but it has become an important part of my life. My blog, Lab Soft News, is located at www.labsoftnews.com (accessed September 23, 2007). It is what I call a professional blog, as opposed to a "Hi, Mom blog." Monday through Friday, I post a blog entry containing about 300 or 400 words. So, basically this amounts to about 90 000 words a year.Basically, I have about 200 visitors a day both in-bound and on an outbound subscription basis, so each week, I "touch" about 1400 visitors. On an annual basis, this is about 70 000 visitors to the blog. These are nonunique numbers, which is to say that some people may be counted twice. However, I view returning visitors to the blog in a very favorable light. I began Lab Soft News by staying very focused on laboratory software issues, but now, because my interests are relatively catholic, I have expanded my perspective to various other aspects of laboratory medicine, anatomic pathology, and to health care in general.The point that I want to make here is that professional blogging offers an extremely valuable forum for launching new ideas and discussing new concepts. Many of the ideas that I present to you on my list of 10 macroforces in anatomic pathology were initially incubated in my blog. The cost for my blog per year is $150, which includes the hosting fees as well as use of the application that allows me to write each of the blog entries in natural language, which gets automatically converted by the application into HTML. For this small yearly cost, I have the ability to present some of my ideas to thousands of people per year. I believe that professional blogging will emerge as an important intermediate step between hallway conversations and formal publications. In the same way as this conference has the ability to present a new agenda for anatomic pathology, professional bloggers in our field also have an opportunity to be change agents and help to transform pathology by promoting new ideas.Before I sketch out the forces that are changing anatomic pathology, I begin by defining anatomic pathology as consisting of surgical pathology, cytopathology, and autopsy pathology. I describe the latter as a "dying art." This morning I asked if such a description was too harsh. On reflection, I must say that I still agree with this description; for various reasons I do not go into a more detailed discussion of the question at this time.I may make some passing references in my remarks to the consequences of the 10 forces that I list, but what I really want to accomplish is to stimulate ideas among the audience members about all of the forces that are affecting anatomic pathology. If any of you would like to substitute a list of different forces at work, that would be welcome because the goal is to create a dialogue about what is now happening.Surgical pathology is a subjective discipline supported by what I would describe as aging technologies. Histopathology remains largely a subjective skill. As a recent National Cancer Institute grant proposal addressing precancer also refers to surgical pathology as being "highly subjective," I am not alone in this opinion.Many of the underlying technologies for surgical pathology such as tissue stains and paraffin embedding have been in use for many decades. The notion of histopathologic diagnosis as a qualitative and subjective discipline is reinforced by our training methods. There may be wide variation among the experts about which diagnosis to assign to a particular lesion, reinforcing this notion of subjectivity.However, histopathology remains the gold standard for tissue diagnoses. It is irrefutable that histopathology and cytopathology now reign supreme as the best means for diagnosing tissue lesions and will continue to reign supreme for some time in the future, despite the fact that they are subjective disciplines. In addition to being highly accurate, histopathologic diagnosis is also relatively inexpensive and very rapid, which reinforces the fact that it is indispensable.We now have emerging an imaging technique, molecular imaging, which is in its early phase but which potentially could be a competitor to surgical pathology and histopathology in terms of tissue diagnosis. Because histopathology is the gold standard, however, the radiologists and the companies that are pursuing research in molecular imaging on the radiology side will need surgical pathologists to validate the diagnoses arrived at using molecular imaging.In identifying my list of 10 forces that are changing anatomic pathology, it became apparent to me that many of these high-level forces are beyond the control of practitioners in the field. In other words, there are large macroeconomic forces at work. However, it should also be emphasized that some can be responded to by local action, and one of the key ideas that I want to endorse is the integration of clinical pathology with anatomic pathology. This is a change that can be endorsed and executed by all pathology departments.Perhaps it would be helpful to keep in mind before I start discussing my list 2 quotes from Wayne Gretzky, one of the greatest hockey players of all time. The first is "It has been proven beyond a shadow of a doubt that you miss 100% of the shots you do not take." Mr Gretzky described the secret of his success as "I skate to where the puck is going to be, not where it has been." Let us keep these ideas in mind as we proceed through the list.I now turn to a discussion of major force No. 1: There is growing interest in what has now been called "the early health model." One of the things that I find fascinating about this future look at anatomic pathology is that many of the key ideas are being launched by for-profit companies such as General Electric (Fairfield, Conn) and Siemens Medical Solutions USA, Inc (Malvern, Pa). The early health model is a concept that is being popularized by General Electric and is being fueled by the new biology. In my opinion, it constitutes a paradigm shift in the manner in which health care services will be delivered.Put very succinctly, the early health model refers to presymptomatic, preclinical diagnosis, and I would now add to that list the diagnosis of precancer. I briefly referred before to a new grant opportunity with National Cancer Institute, dealing with the diagnosis of precancer.The concept of the early health model is going to shake up a lot of important constituencies in health care, such as health insurance companies, clinicians, and pharmaceutical companies. We are going to begin to diagnose presymptomatic, preclinical disease. Clinicians are not trained to diagnose preclinical and presymptomatic disease. The health insurance companies have their hands full simply paying for diseases that are already clinically demonstrable. The pharmaceutical companies are sitting on billions of dollars of intellectual property relating to drugs that have been demonstrated to be effective only for clinically demonstrable disease.The pathologists and laboratory scientists can and should be at the epicenter of this revolution because the diagnosis of preclinical and presymptomatic disease is commonly arrived at using biomarkers. My own belief is that it will be much more cost-effective to diagnose preclinical and presymptomatic disease using serum rather than sending the patients for complex, expensive imaging studies. I believe that the early health model will involve periodic surveillance with large panels of biomarkers. Positive results from such serum screening will then prompt the clinician, who is directing the workup of the patient, to order focused imaging studies to confirm a suspected diagnosis.No. 2: Molecular medicine becomes a major driver in health care. In the same way that this early health model is largely being driven and popularized by General Electric, molecular medicine and so-called full-service diagnostics is being popularized by Siemens. This molecular medicine involves the analysis of the molecular basis of disease and manipulation of those molecules to improve the diagnosis, prevention, and treatment of disease.This notion of molecular medicine and full-service diagnostics is quite synergistic with the early health model because essentially molecular medicine is the tool by which we will execute the early detection and treatment of disease.Molecular medicine also enables the monitoring of treatment efficacy, using biomarkers and medical/molecular imaging, and this segues into a discussion of so-called personalized medicine. This discussion about molecular medicine and the early health model expands the potential for screening programs and assessments of genetic predisposition. A key question at this point is how anatomic pathology and surgical pathology can be converted from a morphology-driven to a molecular-driven medical specialty.No. 3: Clinicians will seek key indicators of prognostic and therapeutic efficacy. There is a major shift underway on the part of clinicians from the emphasis on the diagnosis to the prognosis assessment and monitoring the effectiveness of therapy. The diagnosis shortly will become something that can be arrived at, particularly with large panels of biomarkers, even in an early stage, very quickly.The shift is being spawned by sophisticated medical imaging and molecular diagnosis. In other words, to put it very bluntly, diagnosis is becoming fast and accurate and that would be the very early beginning of the process. What is going to be most significant is prognosis and therapeutic recommendations, and I see the pathologist and the laboratory scientists as working at the center of this process.With personalized medicine and targeted chemotherapy, we will be able to change drugs midstream if no observed, beneficial effects occur. With sophisticated imaging, we will be able to observe minute shrinkage of tumors very quickly to indicate that we are on the correct therapeutic path. For pathologists, the opportunity exists to change the emphasis of reports, make them more consultative than a terse description of the diagnosis, and better respond to the clinician's needs. Here is what they are going to be interested in: "What is the prognosis of this patient, and am I pursuing the correct therapeutic path?"No. 4: Constant pressure for more cost-effective health delivery. This is one of those huge macroforces that will be difficult to grapple with. The key question for pathology and laboratory medicine is how to lower the cost of health care delivery as diagnoses and therapeutic interventions become more sophisticated. These are issues that are driving a lot of the insurance payors to distraction with the increased emphasis on large panels of biomarkers and sophisticated algorithms, which are associated with expensive molecular testing. How do we transition to this early health model when the payors are already spending a lot of money on treating, sometimes ineffectively, an existing disease? My belief is that much of the cost of this health surveillance testing with large panels of biomarkers will be out-of-pocket, but I am not sure how this is going to play out.For neoplasms, the earlier diagnosis and targeted therapy may avoid expensive surgery and prolonged hospital stays, but this advantage may be offset by the increased cost of complex testing and the cost of some of the novel new drugs that are now coming to market.Wellness monitoring and healthy lifestyles may avoid the complications, so in the long run this early health model may cost less, but it may cost more in the short run. How are we going to deal with this? One of the solutions is to anticipate greater out-of-pocket costs for consumers.On my blog, I have discussed some new models for health care delivery such as the walk-in clinics that are being opened in retail drugstores and big-box discount stores such as Wal-Mart. These walk-in clinics, which I believe offer a new paradigm for routine health care delivery, will begin to offer Clinical Laboratory Improvement Amendments–waived laboratory testing for routine problems. You are going to hear much more about these walk-in clinics in the future.No. 5: There is early interest in the merger/convergence of pathology and laboratory medicine with radiology. The rationale for such a change is buttressed by economic, political, strategic quality, and organizational considerations.Medical imaging is, I believe, on a collision course with surgical pathology in the sense that medical imaging will be increasingly able in the future to arrive at a concrete diagnosis. This is where molecular imaging is headed. What I also realized, after going into this topic in some depth, is that radiology is losing control over some of the imaging procedures, and therefore revenue, to clinical specialists such as those in cardiology and emergency medicine. One medical school, with a grant from General Electric, is equipping all of their medical students with portable ultrasound devices. These devices will substitute for the stethoscope and allow very rapid diagnoses at the bedside for many conditions. Thus, you have technology driving and causing "porosity" of the boundaries between specialties, with radiology losing some of its imaging procedures to other specialties.For me, the most important rationale for this idea of conversion/merger between pathology and laboratory medicine and radiology is the quality advantages for the 2 groups and for the patients that they serve. I have this image of an office radiologist sitting next to a pathologist and collaborating and looking at the whole historical record for patients while correlating imaging results with surgical pathology and cytopathology results.No. 6: Multiplex biomarker panels will deliver early diagnosis and wellness monitoring. I believe such panels are much more comprehensive and sensitive than our current methods, such as the yearly, cursory physical examination accompanied by a small set of laboratory tests. What I hear over and over again is that health care consumers today want to know what is going to happen to them in the future on a 3- or 5-year horizon. I know there are a lot of practical and ethical considerations to be considered here and we will need to deal with false-positives. However, I believe that this approach to health care correlates well with early intervention, and I believe that ultimately, early intervention will be more cost-effective.This approach to wellness monitoring is predicated on the knowledge that diseased cells and most notably neoplastic cells communicate with each other by the elaboration of proteins. This is a similar story to that of the Rosetta stone: All we have to do is better understand the meaning of these subtle changes in the level of proteins circulating in the body. This will allow us to arrive at earlier diagnoses assisted by the use of algorithms. That latter step is critical because these data are going to be so complex that we cannot just scan it like in the old days to arrive at the correct diagnosis.No. 7, 8, and 9: Digital pathology begins to emerge as a fully matured discipline; direct searching of image databases becomes practical and commonplace; and hyperspectral imaging supplements brightfield microscopy. I am not going to dwell on these topics because there are too many experts in the room who can discuss them better than I.If and when there is a merger between radiology, pathology, and laboratory medicine, digital pathology will emerge as one of the critical factors in such a partnership. If this conversion were to take place, laboratory data and medical imaging will form the basis for some 80% of all diagnoses rendered and medical consultation will be available on a global basis.This conference features a speaker who discusses NightHawk Radiology (Coeur D'Alene, Idaho). This company is a striking example of the changes that can be effected when a specialty such as radiology goes completely digital. This company has evolved purely on the basis of digital radiology and is responsible for moving images around the world. What is interesting about NightHawk is that the company initially developed software to support and complement its global model of moving radiology images around the world. However, it has now evolved in part into a software company, and it is licensing the software that it created for its own use internally, as part of its business model, to radiology groups that are colocated, allowing these other groups to manage images, reports, and personnel in multiple locations.I believe that direct searching of image databases will become a reality in the very near future. In other words, as pathology becomes fully digital, we will have these valuable databases containing multiple images, and we will be able to search these image databases on a routine basis. We will have real-time access to differential diagnoses of prior cases based on regions of interest in a slide that we are currently studying. There will also be an opportunity for direct searching of image databases to assign a diagnosis to lesions of low incidence. For rare diseases, this will allow faster recognition and understanding that a cohort of distinct cases exist. This will result in simplified consensus generation for rare lesions.Richard Levenson, MD, discusses this topic later in the conference, but we have this new phenomenon emerging of hyperspectral imaging that will be used to enhance and supplement brightfield microscopy in surgical pathology. This will allow us to leverage our existing low-cost, conventional histochemical stains to add significant diagnostic power. This hyperspectral imaging will allow us to apply multiplexed staining to brightfield microscopy using 5 to 8 immunostains in a section.No. 10: We have need for a strategy to counteract the current commoditization of laboratory medicine. This is the result of the national reference laboratories, Quest (Lyndhurst, NJ) and LabCorp (Burlington, NC), competing with each other for insurance contracts on the basis of cost.In my view, the antidote to this challenge will be genomic and proteomic testing, particularly coupled with sophisticated algorithms that allow the interpretation of these test results. We also have an opportunity to provide very sophisticated laboratory consultations that are correlated with medical imaging to offset this commoditization. The secret will be staying ahead of the competition.Another very important phenomenon that is now occurring is so-called medical tourism. Medical tourism involves patients both in the United States and other Western countries traveling to India, Singapore, and Thailand, particularly Bumrungrad Hospital in Bangkok, for surgical procedures that are very expensive in their home countries. For example, the cost of a total hip replacement in India or in Thailand is about one fifth of the cost in the United States. A whole range of services are being outsourced today and health care is not immune to this phenomenon.Yesterday I wrote a blog entry that the Blues, the Blue Cross organizations of South Carolina, have now endorsed medical tourism and, in fact, have created their own company to plan such trips and to coordinate admission to Bumrungrad Hospital for surgical procedures. This is a major change in the attitude of health insurance companies toward medical tourism that I think will continue, particularly with the active support of the Blues.In conclusion, there are major forces now bearing down on pathology that will greatly disrupt our historical franchise and the professional lives of our practitioners. We need to adapt to many of these changes or become irrelevant. The first reform that I believe is necessary will be closer integration of anatomic pathology with clinical pathology. This is critical because genomics and proteomics will be the basis for new biology. The second reform will be closer integration with radiology, and I have personally been an advocate of this conversion of merger, or at least some form of closer interoperation between radiology and pathology.