Summit X Session 1 Overview

Cancer Research in Crisis?: 

Cancer Research in Crisis? Al B. Benson III, MD, FACP Professor of Medicine Associate Director for Clinical Investigations Robert H. Lurie Comprehensive Cancer Center of Northwestern University Feinberg School of Medicine ECOG GI Committee Chair

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Clinical Research in Crisis … Are we headed into the perfect storm?

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“The Promise of Research in a Bleak Fiscal Climate” “Good news is we’re facing the most exciting prospects since the dawn of science for advancing human health.” “Bad news is we’re also facing the most dismal prospects in the history of … NIH for securing the investments that might enable us to realize those advances.” Source: “A Word from the President [Jordan Cohen, MD],” AAMC Reporter, April 2006. Available at http://www.aamc.org/newsroom/reporter/april06/word.htm.

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NCI Tells CCOPs to Slow Patient Accrual To Clinical Trials, Prepare for Budget Cuts THE CANCER LETTER Vol. 32 No. 18 May 12, 2006

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NCI is currently drastically reducing the cooperative group mission by severe cuts in funding, numbers of protocols, and patient accrual Reflects priorities of the NCI Further undermines the value of clinical research Is this to be accepted by the public and oncology community?

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What is driving NIH’s budgetary environment “Perfect storm” scenario Federal Deficit, Defense and Homeland Security priority requirements, Katrina, Pandemic flu and domestic budget cuts (-2.7% for HHS) Sense in Congress that Doubling mission was accomplished and it is “other’s turn” – Physical sciences for competitiveness Overall support for NIH is still strong (No cuts even though HHS total is down 2.7%) Senate vote, positive response to House hearings. But Biomedical research inflation is around 4%. Elias A. Zerhouni, MD, Director, NIH May 2, 2006

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Cancer Clinical Trial Statistics 4970 cancer clinical trials in US diagnosis, treatment, symptom management 3200 trials pertain to treatment of cancer - 1405 (44%) supported by federal funds - remaining trials: pharmaceutical companies, academic centers, private foundations, single investigators

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Why Cancer Research Is Seen As in Crisis NCI’s annual budget almost doubled between 1998 and 2003 but is currently 11% below the 2003 level, in inflation-adjusted dollars Much of the 1998-2003 increase in NCI funding was spent for construction of new cancer research and treatment facilities new PIs and new laboratories many more post-doc positions

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Why in Crisis (2) It costs much more, now, to keep this greatly increased research infrastructure – both human and physical – active, than was being spent at the end of the “doubling” period The number of applications for NCI grants increased by 1,076 in the last 2 years, reflecting the growth in human and infrastructure resources resulting from the “doubling years” the total number of grant applications increased by only 1,371 during the 5 doubling years

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Why in Crisis (3) The average age of PIs when receiving their 1st NIH R01 is steadily increasing* 43 for MDs – 42 for PhDs The R01/R21 pay line is at about the 11th percentile, an all-time low Both new oncologists and seasoned researchers are now said to favor clinical careers, as more appealing than research * Source: NIH (as referenced in “Promoting Translational and Clinical Science,” report of AAMC Task Force II on Clinical Research, 2006). Avail.: www.aamc.org/publications

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Cancer Care Achievements over 30 years Expanded access to oncologic care Shift to outpatient care Integrated office-based oncology services Oncology nursing Home nursing Supportive care services / symptom management Palliative care / hospice Diagnostics Prevention

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Treatment: integrated multi-modality care Improved survival Clinical trial availability Clinical trial networks: Community Academic Cancer Centers Public (Cooperative groups) Industry Cancer Care Achievements over 30 years

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Education: health professional public Advocates Guidelines Compendia Cancer Care Achievements over 30 years

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Oncology: The sum of parts Office-based practice Reimbursement Hospital services Clinical trials Government: CMS FDA NIH

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Education Advocates Multi-disciplinary services Philanthropy Voluntary services Oncology: The sum of parts

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CANCER 30 YEARS AGO Only able to detect large, advanced tumors Short Survival Times One child in 10 survives cancer Treatments were empirical, painful and required long hospital stays No early detection Elias A. Zerhouni, MD, Director, NIH May 2, 2006

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2003 10.5 million Americans alive with cancer 2.4 million : breast 1.9 million : prostate 1.1 million : colorectal 65% survive 5 years Person years of life lost : 15 8.7 PYLL More than any other disease

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Trends in Five-Year Relative Survival Rates (%) for Selected Cancer Sites Jemal A, et al, CA 55(1):10-30, 2005

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Trends in Five-Year Relative Survival Rates (%) for Selected Cancer Sites (cont.) Jemal A, et al, CA 55(1):10-30, 2005

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Blendon RJ, et al., NEJM 355(18):1928-1933, 2006 Most Important Issues for Voters in the Congressional Elections of 1998, 2002, and 2006 *

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Blendon RJ, et al., NEJM 355(18):1928-1933, 2006 Most Important Health Care Issues for Registered Voters in the Congressional Elections of 2002 and 2006 *

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Personal Health Care Spending, 2004 Total - $1.44 trillion Hospital care – 36% Physician and ancillary care – 26% Prescription drugs – 12% Nursing home care – 8% All other – 18% Note: Detail not separately available for cancer care Source: Center for Medicare and Medicaid Services (CMS), Office of the Actuary

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National Cancer Treatment Expenditures in Billions of Dollars (1963-2004) Source: 1963-1995: Brown ML, Lipscomb J, Snyder C. The burden of illness of cancer: economic cost and quality of life. Annual Review of Public Health 2001;22:91-113. 2004: NIH Cost of Illness Report to the U.S. Congress, 2005; National Health Care Expenditures Projections: 2003-2013, http://www.cms.hhs.gov/statistics/nhe/projections-2003/proj2003.pdf

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Future Cancer Treatment Costs Will  faster than overall medical expenditures aging population  - absolute number of cancer cases  faster than overall population - cancer cases  relative to other diseases (even if incidence is stable or ) - new tx will  costs

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Cutler D et al. N Engl J Med 2006;355:920-927 Causes of Increases in Life Expectancy among Newborns, 1960-2000

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Cutler D et al. N Engl J Med 2006;355:920-927 Present Value of Average Medical Spending per Person According to Age Group and Year

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What’s Really Propping Up The Economy Since 2001, the health-care industry has added 1.7 million jobs. The rest of the private sector? None. By Michael Mandel Business Week, September 25, 2006, p 55

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Oncology on the defensive Clinical trial adverse events CMS FDA Pubic perception cost and reimbursement Conflict of interest Media coverage Pharmaceutical industry Clinical research undervalued: Academics Government Barriers

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SPECIAL REPORT / THROWAWAY WORKERS Unpaid bills squeeze U.S. hospitals’ resources When a Longer Life costs too Much October 22, 2006 CMS cuts physician reimbursement Research costs for individual drugs could reach $2 billion by 2010

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Los Angeles Times Drug Trials with a Dose of Doubt A National Institutes of Health researcher with ties to pharmaceutical firms helped test their new medications. Some scientists questioned the results of the studies. Sunday, July 16, 2006 FDA TO PATIENTS: DROP DEAD FDA TRIALS COST LIVES FDA SUSPENDS TRIALS AT CANCER CENTER IN NEW JERSEY OVER PATIENT MONITORING September 24, 2002 April 3, 2002 September 22, 2000

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HEALTH & FITNESS Despite Equal Cancer Care, A Racial Disparity Persists September 26, 2006

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SundayBusiness Sunday, October 1, 2006 Hope, at $4,200 a Dose Why a Cancer Drug’s Cost Doesn’t Hurt Demand By ALEX BERENSON HARGING $4,200 a dose for a new version of an old cancer drug has helped make Dr. Patrick Soon-Shiong a billionaire. C

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Johns Hopkins Faults Researcher in Human Drug Trial Johns Hopkins Investigating Clinical Trial in India Patients Allegedly Were Not Fully Informed of Risks of Cancer Drug Used in Research Study November 13, 2001 July 31, 2001

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Shying Away from the Cutting Edge Shortage of Patients in Clinical Trials Inhibits Cancer Research, Study Says Study Says Medicare Overpaying for Drugs June 1, 1999 November 28, 1998

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NBC Story on Chemotherapy Reimbursement September 21, 2006 “NBC Nightly New with Brian Williams ran a two and a half-minute story on the subject of reimbursement for chemotherapy treatment.” “Regrettable, this story is incorrect and misleading, both in its mischaracterization of “marked up” prescription and in irresponsible implying that oncologists make treatment decisions based on business considerations, rather than on the most effective treatment.” ASCO Cancer Policy Alert

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Top 10 Trends Impacting Physician Practices Expanding acceptance of clinical information systems Physician supply The Aging Boomers A push to work “smarter” not “harder” Reporting and benchmarking of outcome data Changing nature of hospital and physician relationships Physician reimbursement Community or network (IPA) based initiatives Medicare as a “retail” business Medicare Part D drug benefit Camden Quarterly Vol X (2), 2006

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ASCO Recommendations NCI: “frequently the standard of care for a particular type or stage of cancer involves the off-label use of one or more drugs” FDA: “under certain circumstances, off-label uses of approved products are appropriate, rational, and accepted medical practice” NCI: “since drugs used off label are often the standard of care for a particular kind of cancer, insurers’ denial of coverage for such treatment means that patients may not receive what their doctors consider the best available treatment for their disease.” J Clin Oncol 24:3206-3208, 2006

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ASCO Recommendations Use statutory authority to include all qualified compendia for use in the Medicare program. Work with the cancer community to identify the full range of legitimate, peer-reviewed scientific journals that may be relied on by carriers in determining coverage decisions. Require Medicare contactors to take into account peer-reviewed literature from these reliable sources as they determine coverage. J Clin Oncol 24:3206-3208, 2006

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NCI is currently drastically reducing the cooperative group mission by severe cuts in funding, numbers of protocols, and patient accrual Reflects priorities of the NCI Further undermines the value of clinical research Is this to be accepted by the public and oncology community?

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What All of Us Should, As Stakeholders, Be Doing Work together to stabilize research funding NCI, and NIH as a whole, believe that a +5% annual budget increase is essential, in order to maintain the last decade’s momentum the yet-to-be-passed NIH Reauthorization Bill (HR 6164) allows only 5% annually including inflation NCI’s “bypass budget” for FY 2008 requests a 23% increase over FY2007 spending We all need to learn how to explain why a bit more is still needed to members of Congress and their staffs to biopharmaceutical manufacturers

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What We Should Be Doing (2) Work together to reduce costs by standardizing and centralizing more functions of the overall clinical research enterprise Cancer Centers, SPOREs, CCOPs, Cooperative Groups, and their NCI sponsors should collaborate, not compete Explore mutually beneficial mechanisms for increasing biopharma industry support

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Stakeholder Collaboration Possibilities Develop a focused educational program to overcome the widely held perception that NCI has enough resources involve PhRMA and BIO representatives Explain 1-to-1 to Hill staff members why the NCI needs annual 5% increases Inventory currently successful models of Cancer Center – Group – CCOP collaboration, to develop best practices for additional efforts

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Our Challenge More than ever, we need to work together in a tough fiscal climate, to determine our rock-bottom needs, in order to best serve our patients now and in the future how to obtain the support required to achieve those needs

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What’s Wrong with Crisis Thinking Discoveries, especially in biotechnology and “personalized medicine,” are happening faster than ever Cancer incidence rates are beginning to decline For the last 20 years, the total cost of cancer care has steadily been less than 5% of all health care costs, about $72 billion out of $1.44 trillion.

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Strategies The cancer community is doing its job. We have created a practice and research infrastructure to enable us to do our job. We need to articulate #1 and #2 and: Package Oncology Advances - What we need - Why we need it - What will be lost: • translational research • patient accrual – impact on drug development • public sector as only independent group for Phase III clinical trials • loss of infrastructure: community and academic

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Strategies Package Oncology Advances (continued) - Public sector clinical trial contributions - Industry relationships Economics of cancer Global impact Jobs, products, expenditures, export of technology Target policy makers Move from the defensive Produce evidence – all components - What we have - What we need - What we can lose Academic medicine - promote value of clinical research