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
Slide2 : Clinical Research in Crisis … Are we headed into the perfect storm?
Slide3 : “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.
Slide4 : NCI Tells CCOPs to Slow Patient Accrual To Clinical Trials, Prepare for Budget Cuts THE CANCER
LETTER Vol. 32 No. 18
May 12, 2006
Slide5 : 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?
Slide6 : 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
Slide7 : 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
Slide8 : 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
Slide9 : 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
Slide10 : 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
Slide11 : 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
Slide12 : 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
Slide13 : Education: health professional public
Advocates
Guidelines
Compendia Cancer Care Achievements over 30 years
Slide14 : Oncology: The sum of parts Office-based practice
Reimbursement
Hospital services
Clinical trials
Government:
CMS
FDA
NIH
Slide15 : Education
Advocates
Multi-disciplinary services
Philanthropy
Voluntary services
Oncology: The sum of parts
Slide16 : 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
Slide17 : 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
Slide18 : Trends in Five-Year Relative Survival Rates (%)
for Selected Cancer Sites Jemal A, et al, CA 55(1):10-30, 2005
Slide19 : Trends in Five-Year Relative Survival Rates (%)
for Selected Cancer Sites (cont.) Jemal A, et al, CA 55(1):10-30, 2005
Slide22 : Blendon RJ, et al., NEJM 355(18):1928-1933, 2006 Most Important Issues for Voters in the
Congressional Elections of 1998, 2002, and 2006 *
Slide23 : 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 *
Slide24 : 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
Slide25 : 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
Slide26 : 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
Slide27 : Cutler D et al. N Engl J Med 2006;355:920-927 Causes of Increases in Life Expectancy among Newborns, 1960-2000
Slide28 : 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
Slide29 : 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
Slide30 : 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
Slide31 : 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
Slide32 : 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
Slide33 :
HEALTH & FITNESS
Despite Equal Cancer Care, A Racial Disparity Persists September 26, 2006
Slide34 : 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
Slide36 : 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
Slide37 : 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
Slide38 : 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
Slide39 : 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
Slide40 : 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
Slide41 : 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
Slide42 : 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?
Slide43 : 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
Slide44 : 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
Slide45 : 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
Slide46 : 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
Slide47 : 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.
Slide48 : 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
Slide49 : 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