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ASCO in the 21st Century: Challenges and Opportunities—ASCO Presidential Address 2005

Division of Hematology and Oncology, Vanderbilt-Ingram Cancer Center, Nashville, TN

INTRODUCTION

I would like to welcome you to the 41st Annual Meeting of the American Society of Clinical Oncology. I sincerely hope you are enjoying this fantastic meeting that was made possible through the tireless efforts of numerous member volunteers and an incredibly dedicated ASCO staff.

Last year, we celebrated ASCO's 40th anniversary and its impressive history. We paid homage to the men and women who helped make ASCO the great organization it is today. I believe ASCO's future, however, will be far different than our rather bucolic past. For one thing, ASCO has become a very big tent—an international community of clinicians and researchers who practice in both academic and community settings. Acknowledging the varied interests of such a diverse membership is an ongoing challenge for ASCO leadership, as there are many views of how our priorities should be aligned. Certainly during my presidential year, I frequently felt the tug of competing agendas, but through it all I worked hard to keep the focus of the Society where I believe it belongs—on our patients and on advancing the science of clinical oncology.

Achieving and maintaining quality cancer care for our patients is the major theme of my address, as I believe it has been throughout my presidency. Frankly, in preparing for today's address, I thought of many possible themes to try to capture the spirit of the past year, including the apt but apocryphal Chinese curse: "May you live in interesting times." Certainly, there have been times during the past year when I felt the burden of continuing assault by "interesting issues and challenges." And these "interesting" challenges have brought important major changes to oncology, to ASCO, and to the care of our patients.

Although there are many challenges confronting ASCO, I will address four issues that I believe will dominate ASCO's immediate future and therefore require our collective attention:

• On the domestic front, 2005 saw major changes in the way that Medicare pays for cancer care. The net result of these changes was a significant reduction in revenue for oncology practices, potentially threatening access to high-quality cancer care.
  
• At the same time, the withdrawal of high-profile drugs such as Vioxx and Bextra from the marketplace rekindled public and governmental concern with the safety record of drugs taken by large segments of the population for chronic diseases like arthritis. In turn, this renewed attention to drug safety could lead to regulatory policies that may inadvertently make it harder to rapidly introduce new cancer drugs into the clinic.
  
• On the research-funding front, the 5-year program of "doubling" the budget of the National Institutes of Heath [NIH] has come to an end. A new era of fiscal restraint has dawned. The impact of this deceleration of research spending has yet to be fully assessed, but is already causing considerable concern in academic and research communities.
  
• And looming large over the oncology community are fundamental questions about the ethics of our research activities, of our interactions with the pharmaceutical industry, and of our dealings with one another as well as our patients.
  
• Let me address ASCO's response to each of these issues under my presidency.
  

MMA 2003: REIMBURSEMENT CHALLENGES AND THE THREAT TO QUALITY CANCER CARE

A topic of great concern to our domestic members was the Medicare Modernization Act of 2003. The new law went into effect this January [2005] and adjusted payment for cancer drugs, eliminating so-called drug profits and substantially reducing payments for cancer care. The net effect was the potential for a major disruption in the delivery of cancer care in the United States. Federal Medicare officials, under the leadership of Dr Mark McClellan, recognized the potential problems created by the shortfall, and acted to soften the impact of this legislation by establishing a demonstration project that would pay physicians for what they do for patients (ie, for managing common side effects of chemotherapy and for managing symptoms of cancer itself). ASCO played a major role in shaping this common sense policy. Aside from the fiscal relief represented by the demonstration project, it also moved the Medicare system in a direction that we all can support and endorse, which is to recognize the delivery of quality cancer care and to ensure that it is properly reimbursed. We are hopeful that the demonstration project will continue beyond its current 1-year charter so that the system can be reformed with minimal disruption. Deborah Kamin and her staff now meet regularly with CMS [Centers for Medicare and Medicaid Services] to help create a more appropriate system whereby oncologists are properly compensated for providing high-quality care. Moreover, ASCO is helping to define the tenets of high-quality cancer care through a number of initiatives I will discuss momentarily.

Another area of important interaction with CMS has to do with coverage decisions (ie, deciding which treatments will be considered medically necessary and thus "covered" by the Medicare program). With rising health care costs, payers have an impulse to restrict coverage as a way of restraining costs. Clearly this is not in the best interests of our patients. Congress has given special status to cancer drugs for so-called off-label uses, and we have had many discussions with CMS in recent months about how to implement these protections. Important coverage decisions have been made on colorectal cancer drugs, on PET [positron emission tomography] scans, and on oral antiemetics. In our discussions with CMS, ASCO has insisted that these coverage decisions be evidence-based rather than being based solely on cost considerations. It is ASCO's firm position that evidence-based quality cancer care is cost-effective care.

QUALITY CANCER CARE CHALLENGES

ASCO is making its own investment in ensuring quality cancer care through a variety of initiatives. This includes the National Initiative on Cancer Care Quality (NICCQ), a multimillion-dollar study of cancer care patterns, initiated 6 years ago under the presidency of Joe Bailes. According to some reports, including an Institute of Medicine report,¹ Americans receive only approximately 50% of the preventative, acute, and chronic medical care recommended by experts.² The ASCO-funded NICCQ study challenges this assertion in cancer care. Moreover, the study will provide prospectively determined parameters that can be used in the future to judge the quality of cancer care actually being delivered.

In addition, ASCO is funding the Quality Oncology Practice Initiative (QOPI). QOPI, which has grown to include over 400 ASCO members from around the country, is designed to collect "real life" data from community and academic practices, to develop common sense measures that can be used to objectively assess the quality of cancer care actually delivered. This unprecedented "self assessment" program not mandated by any government entity but rather started on the initiative of ASCO oncologists themselves exemplifies the dedication of our members to ensuring that cancer patients receive the very best care possible.

Of course, a critical aspect of quality care is to assure that all patients, regardless of their circumstances, have access to quality cancer care. The problems of health disparities, both in the United States and abroad, concern us all. In the coming year, an ASCO Task Force will be addressing these issues, providing recommendations for specific actions our Society can take to assure that a diverse, representative community of oncology providers is able to reach every cancer patient with the care they need.

Concern about quality cancer care, by the way, cannot be an issue that comes and goes according to the whims of the current ASCO President and Board. As an organization, ASCO must embrace the concept of quality care as a core issue. The quality of the care we deliver is vital to the collective health of all of us—for our patients as well as our profession. Therefore, to coordinate all these quality care initiatives and to ensure their efficient operation, I have appointed a Quality Advisory Group comprised of recognized experts in the fields of health services and quality care research. In addition to providing oversight and coordination of the ASCO quality initiatives, this group will be charged with translating their outcomes into policies and actions.

Most of you know that the Federal government also is overtly pursuing a quality agenda that we hope will concentrate more on quality assurance rather than on cost savings. So-called "pay for performance" programs are in development both in the Executive Branch and in Congress.³ All too often, however, a concern about "quality" is merely a surreptitious way of attempting to extract cost savings. Oncologists need to be proactive participants in the process that defines how a P4P is developed and implemented. We cannot afford to leave decisions about quality and measures of quality to others. This is why NICCQ and QOPI are so critical. ASCO and select representatives of our robust patient advocate community are working closely with Medicare officials to help shape the pay for performance program in oncology. We are involved because CMS and Congress alike acknowledge that ASCO's expertise and leadership is a crucial ingredient to the success of any such program. So while Medicare payment reform has been a cause for great concern, it presented the opportunity to convert our payment system from one dependent on "the selling of drugs" to one that is based on the "services we provide." Years ago, one of my medical school mentors reminded me that physicians should be paid not for what they do to patients but rather what they do for patients. Hopefully, we are moving towards a payment system based on this philosophy.

DRUG SAFETY AND THE UNITED STATES FOOD AND DRUG ADMINISTRATION CHALLENGES

The assurance of Quality Cancer Care in the future also depends heavily on the ability of the Food and Drug Administration, and sister agencies abroad, to evaluate new cancer therapies in an efficient and effective manner. Recent concerns about the safety of some drugs taken by large numbers of patients for chronic conditions, such as the COX-2 inhibitors, have cast a pall across the prospects for the rapid approval for all drugs currently in development, including those being developed for life-threatening diseases like cancer.

The drug safety debate, while disconcerting in some respects, has provided us with a forum in which to emphasize how the appropriate risk-benefit balance of most cancer drugs differs from that of arthritis and other chronic care drugs that have been the target of drug reformers. As each of you knows, the safety risks of drugs must be balanced against their potential benefit. The "risk-benefit ratio" clearly changes with specific disease states. What might apply for a chronic illness like arthritis most assuredly does not apply for life-threatening diseases like metastatic lung or colon cancer. With the establishment of a new oncology office at United States Food and Drug Administration which ASCO strongly endorsed and lobbied hard to obtain, coupled with the selection of Dr Richard Pazdur as its director, we are hopeful that the appropriate balance will be struck going forward.

In addition to collaboration on more efficient review processes, ASCO will continue to sponsor with the United States Food and Drug Administration a series of expert panels that will address creative new end points for cancer clinical trials. As our knowledge of cancer biology improves, we must develop end points that reflect this new knowledge and permit a more efficient assessment of new agents.

A related challenge to the United States Food and Drug Administration and to oncologists lies in the desire of some individuals and groups to make new investigational drugs available "on demand," with little or no evidence of effectiveness. We do our patients no good if we allow them to be seduced by unsubstantiated promises of "benefit" when the evidence is only beginning to accumulate. ASCO believes there is an appropriate role for well-organized "expanded-access programs" to give patients who, for one reason or another, have not been included in clinical trials or otherwise had access to a promising investigational agent, but only when there is some reasonable evidence the new drug can be effective.

CHALLENGES CONFRONTING CLINICAL RESEARCH

As for research funding, the NIH budget has doubled over the past several years, which is gratifying; but we know that a continued increase in federal funding is not likely to occur anytime soon. We must now concentrate on how best to spend our available resources for clinical as well as basic research. The NCI (National Cancer Institute) is addressing this need in part through the work of the Clinical Trials Working Group chaired by Dr Jim Doroshow. Jim is joined in this effort by clinical trials experts and leaders from the private sector, academia, and industry. This kind of reassessment of resource allocation is clearly needed and must be done on a regular basis.

We should also explicitly recognize a trend that has been developing for quite some time now; namely, the increasing role of research funding derived through industry and private foundations, and even more recently, the efforts of some state governments to fund clinical and basic science research (eg, the California Stem Cell Research Initiative). We must explore all options for optimizing collaboration between public and private research funding resources to ensure that progress continues at an optimal level. These kinds of public-private collaborations will inevitably raise questions about ethics and potential conflicts of interest. In light of the many competing financial interests involved in the current cancer care environment, it is absolutely essential that public confidence in the basic integrity of oncology be bolstered and maintained.

While I am on the subjects of drug development and clinical trials, I would like to offer a personal observation. I have become increasingly concerned about our ability to take full and effective advantage of our burgeoning knowledge of tumor biology. I worry that the "need for speed" in getting drugs to market may be outstripping our ability to apply good science to study design. Some of the large-scale trials done in the past 5 years have not taken full advantage of our existing scientific knowledge. These failed trials resulted in wasted time, money and precious human resources. These unsuccessful trials were no doubt driven in part by industry's need to move new agents quickly into the marketplace. SMARTER trials, ones that take full advantage of our scientific knowledge, are needed, are likely to be less costly in the long run, and are better for the successful development of new molecularly targeted agents. Achieving true personalized medicine, something we can all support, will require the continued close collaboration of investigators from the entire oncology community. As an organization dedicated to clinical research, ASCO should champion and promote the performance of high-quality cancer clinical trials. Toward that goal, ASCO joined with AACR (American Association for Cancer Research), the Association of American Cancer Institutes, NCI, the United States Food and Drug Administration, and representatives from the pharmaceutical industry to explore creative strategies for improving the quality of cancer clinical trials in the coming years. This initiative, known as SMART Trials, will take a commitment on the part of clinical investigators, government researchers and industry to the concept of team science. Individual investigators may find credit hard to come by with this approach, and drug companies will surely worry about protecting their intellectual property. These are very real concerns but they must be overcome, or progress will continue to be slow.

It is hardly hyperbole to state that the National Cancer Institute is one of the premier cancer research institutes in the world. This intellectual incubator has nurtured several generations of qualified scientists. However, with the flattening in federal research funding, maintaining high quality cancer research at the NIH is also becoming a challenge. The NIH leadership must attempt to optimize the federal investment by concentrating on doing more with less. This will not be easy task, or popular one. In part, this effort may very well depend on the creation of meaningful partnerships with the private sector such as the SMART Trials initiative I've just described. Although "public-private partnerships" has been a recurring theme at NIH, recent actions by the federal government have placed such relationships more at risk than ever. I am of course referring to the controversial new ethics standards imposed on NIH employees. Some experts view the new NIH ethics standards as overreaching and burdensome. As written, they even cast doubt as to the ability of an NIH scientist to participate as a volunteer in an organization like ASCO. Does this restriction serve the public good? In my opinion, these restrictions should be reconsidered and recast to be more moderate in their scope and impact.

ASCO ETHICS AND CONFLICT OF INTEREST POLICY

Of course ASCO itself has grappled with questions of ethics and conflicts of interest (COI), financial and otherwise. As an organization, ASCO is committed to ethical conduct and full disclosure of financial interest in all of its programs and by its membership. This stance has been controversial, clearly challenging and difficult. In 2003, ASCO adopted a conflicts of interest policy that was perhaps the most stringent of all major medical societies. While it mostly relied on full disclosure of financial interests, it also recognized that certain officials in clinical trials, mainly the principal investigators, were so pivotal to the undertaking of that trial that their financial interests should be limited, and not merely disclosed. This position sparked an outpouring of divergent and polar opinions from our membership, both domestic and international. Believe it or not, our membership does not hold a single view on what constitutes "ethical behavior" when it comes to the conduct of clinical research and interacting with sponsors of clinical research. In response to input from our members, and with guidance from the ASCO Ethics Committee, we have reviewed and revised the COI policy to address the very real concern that the scientific and educational missions of ASCO might be jeopardized unless some flexibility was introduced. The policy, however, remains a strong and aggressive one that is still at the forefront of ethics efforts by medical organizations.

Despite these efforts, there remains an over arching concern about ASCO's obvious relationship with industry. In an effort to make myself more knowledgeable in this regard I spent a good bit of time during the past year reading about the medical profession and our relationships with the pharmaceutical industry as well as our relationships with one another. The picture that emerged from this literary journey was not too flattering. Last fall, David Blumenthal published an article in the New England Journal of Medicine entitled "Doctors and Drug Companies."⁴ In it he asserted: "there is an increasing recognition by both pharmaceutical companies and physicians that, in certain respects, the relationships between drug companies and doctors have become embarrassing to both parties and need to change."⁴ Just as new approaches to measuring and ensuring quality cancer care have emerged from recent reimbursement changes, so may a re-examination of our relationship with industry engender a better outcome for all concerned.

Clearly, pharmaceutical support for this meeting and other ASCO programs is unmistakable. And many if not most oncologists, me included, have a complicated relationship with industry. Both ASCO and its individual members need the pharmaceutical and biotechnology industries as partners in our efforts to achieve clinical benefit for our patients. But if public confidence is to be maintained, there must be a continual re-examination of these relationships. We need to ensure that we are motivated solely by considerations of quality care for our patients and not by financial or commercial incentives. With that goal in mind, ASCO began a process of reassessing its relationship with industry shortly after I took office last summer. Although some may view this undertaking with healthy skepticism, I believe the process is being conducted in a prudent and reasonable manner. This spring, for example, ASCO leadership met with the chief executives of several of the major pharmaceutical companies to discuss new rules and boundaries governing the interactions between our society and pharma. I believe it was a productive first step towards redefining our society's relationship with the pharmaceutical industry. I do not yet know the outcome of this important initiative but I do know that it is a necessary undertaking if the credibility of ASCO, as well as industry itself, is to be salvaged. This initiative will continue under Dr Horning's able leadership.

CONCLUDING REMARKS

As I reflect on my year as the ASCO president, I liken it to an internship year. No doubt each of you remembers vividly your time as a young house officer. During the transition from neophyte to full-fledged physician, our attitudes sometimes transitioned as well, from that of a wide-eyed idealist to an occasional late night cynic. When we emerged from training and began to work in a community or academic practice, we typically recaptured that early idealism and enthusiasm, anxious to move on with our professional lives. But over time, the press of daily challenges, including many of the issues I've discussed today, may have eroded that "sense of purpose" that first brought us to the profession of medicine. I confess that I may have lapsed into this dispirited frame of mind once or twice in the past year. Fortunately a close colleague encouraged me to reread Michael Bliss's wonderful biography of William Osler entitled A Life in Medicine.⁵ If you have not read this book, I urge you to do so. In the introduction, Professor Bliss admitted to being somewhat skeptical that Osler could possibly have measured up to the person described in Harvey Cushing's 1920s encomium. Bliss goes on to admit that his initial impression was wrong, and after carefully researching his subject, he concluded that Osler was the consummate physician, the doctor that each of us imagined we would be the day we received our letter of acceptance to medical school. Let me read to you Bliss's description of Osler: "No one has ever loved the medical life more than William Osler did. From the day he decided to become a doctor until the day of his death he lived, breathed, ate, slept, talked and wrote medicine. Osler was committed to excellence in the practice of medicine in a way that dazzled both his students and his colleagues. He ... never cut corners, never avoided confronting his mistakes, never became set in his ways. Most of the students et al who observed Osler with patients thought he was the best they had ever seen. Most of the patients thought so too."

Reading Bliss' book reminded me, again, just how fortunate each of us is to be a physician. As oncologists, we administer to the sickest of the sick –the most vulnerable of patients. It is truly a rare privilege that we enjoy and one we should treasure. I was also reminded of the fundamental need for us to reconnect with our patients—if we have lost our focus—and recommit ourselves to our profession and to the reason we became physicians and oncologists in the first place. Challenges imposed by reimbursement changes or regulatory burdens must retreat before our most fundamental charge, which is to put our patients first and to do all we can to treat their disease and to alleviate their suffering.

Let me offer a final literary comment about our profession. Atul Gawande, a surgeon at Harvard Medical School, wrote an interesting article in the New Yorker last December entitled "The Bell Curve," in which he talks about the coming era of paying for performance.⁶ Not surprisingly, this approach to payment makes all physicians nervous; it makes oncologists especially nervous. Indeed, how do we define success when it comes to the care of a patient with cancer? We are not the only profession coming under increased scrutiny for our performance and, although grading can be unfair and misused, it is here to stay. There is a bell curve in every human endeavor, and medicine is no different. Although most of us would like to avoid doing so, each of us must continually examine our professional abilities. But if in doing so you were to determine that your abilities were greatly inferior to that of your colleagues, what would you do? Would you stop practicing oncology? What if you turned out to be simply "average"? We could, I suppose, comfort ourselves by claiming that someone has to be average, so why not me? Gawande points out that in some matters—looks, wealth, sports—we would do well to accept our "averageness." But when the stakes are the lives of our patients, can we afford to be average? Like Osler, we should strive to be the very best doctors we can be. As an organization ASCO can help each of us to achieve a higher level of competence, to become better and more knowledgeable oncologists. Moreover, by working together, we can inspire one another to achieve an even higher level of cancer care for our patients, through our efforts to advance the clinical science of oncology.

In closing, let me say that I am truly honored to have served as your president. I look forward to working with our new president, Sandra Horning. I greatly value the wise counsel she and my predecessor Margaret Tempero provided to me this year. Each went "above and beyond" to help me through this most challenging year. To both of them, I say "thank you!" I also wish to thank my Vanderbilt colleagues whose support has been invaluable and frankly never repayable. Most of all I wish to thank my wife and my daughter who have put up with me for more years than either cares to remember. Their love and support has been unwavering and for that I thank them from the bottom of my heart. Anyone who has served in this position knows that the job of ASCO president cannot be done without a supportive family, good friends, and wonderful colleagues. Finally, I wish to pay tribute to two departed friends—my brother-in-law Harold Bridges and my colleague Dr Phil Browning. Both men died this year of metastatic colon cancer after waging heroic and uncomplaining, but ultimately unsuccessful, battles against their cancers. As is so often the case when ministering to an individual with cancer, each of them provided me and others with inspiration and courage.

Colleagues, the future of oncology and that of ASCO is as bright as we wish to make it, as long as the focus remains on our patients. Despite the many challenges confronting us today, there has never been a more exciting time for our profession and the science of oncology. I encourage you to continue working with ASCO and its leadership as we struggle together to find the best path to a better future for our profession and for our patients.

Author's Disclosures of Potential Conflicts of Interest

The author or immediate family members indicated a financial interest. No conflict exists for drugs or devices used in a study if they are not being evaluated as part of the investigation. For a detailed description of the disclosure categories, or for more information about ASCO's conflict of interest policy, please refer to the Author Disclosure Declaration and the Disclosures of Potential Conflicts of Interest section in Information for Contributors.

Authors Employment Leadership Consultant Stock Honoraria Research Funds Testimony Other David H. Johnson Merck (A); Genentech (A) Genentech (C)

Dollar Amount Codes (A) < $10,000 (B) $10,000-99,999 (C) $100,000 (N/R) Not Required

Author Contributions

Manuscript writing: David H. Johnson Final approval of manuscript: David H. Johnson

 

REFERENCES

1. Kohn LT, Corrigan JM, Donaldson MS: To Err Is Human: Building a Safer Health System. Washington, DC, National Academy Press, 2000

2. McGlynn EA, Asch SM, Adams J, et al: The quality of health care delivered to adults in the United States. N Engl J Med 348:2635-2645, 2003[Abstract/Free Full Text]

3. Berwick DM, DeParle NA, Eddy DM, et al: Paying for performance: Medicare should lead. Health Aff (Millwood) 22:8-10, 2003

4. Blumenthal D: Doctors and drug companies. N Engl J Med 351:1885-1890, 2004[Free Full Text]

5. Bliss M: William Osler: A Life in Medicine. New York, NY, Oxford University Press, 1999

6. Gawande A: The bell curve. The New Yorker. December 6, 2004

This Article Full Text (PDF) Purchase Article View Shopping Cart Alert me when this article is cited Alert me if a correction is posted Services Email this article to a colleague Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Save to my personal folders Download to citation manager Citing Articles Citing Articles via Google Scholar Google Scholar Articles by Johnson, D. H. Search for Related Content PubMed PubMed Citation Articles by Johnson, D. H.