|The Cancer Landscape
International Myeloma Foundation
OVAC Advocacy Day
Washington, DC, June 3, 2002
Chair of the
Good morning. My name is Greg Brozeit and I am the advocacy consultant for the Los Angeles-based International Myeloma Foundation (IMF). The IMF is oldest and largest organization serving the needs of the multiple myeloma community. Myeloma is an incurable cancer of the plasma cells of the bone marrow. Its population represents one percent of all cancer diagnoses and two percent of the cancer mortality rate.
I have become convinced that the One Voice Against Cancer agenda, especially with its emphasis on the Bypass Budget which you will hear more about later, is the best hope for my constituents in the myeloma community to realize the goal of more funding for myeloma research. And the same holds true for virtually every other cancer disease-specific constituency if we are to discover better treatments and, ultimately cures for the various cancers.
We, the cancer community, will not achieve our common goals unless we develop grassroots political activism on a scale equal to other powerful public interest groups. It may be the only way to meaningfully accelerate federal funding for cancer research. If based purely on scientific opportunity, cancer research should be getting more. The biggest obstacle, in my opinion, is that we cancer advocates don't advocate for cancer research. Instead we focus far too much on "our" particular type of cancer. And we do so at the expense of the greater good.
In reality, effective political work at the micro, disease-specific, level can hurt the larger cause. In fact, as we look at the current situation, it can be argued that political support for medical research in Congress, in general, and cancer research, in particular, has occurred despite the cancer advocacy community as much as because of it.
The only way to overcome these problems is for us to check our respective baggage at the door. We must come together because all of our goals are so similar. Most of our respective cancer disease groups are too small and unknown to create a popular groundswell for our issues. Success may only happen if One Voice can establish a grassroots constituency for federally funded cancer research that transcends our parochial desires.
I have often wondered why—when 1.2 million persons are diagnosed and another 500,000 die each year of cancer in this nation—cancer advocates cannot muster more voices in support of research. I remember the first day I ever spent in Washington, DC; the day of the annual Right to Life March on which tens of thousands of advocates descend on Capitol Hill. I remember working as a Senate staffer handling the Clarence Thomas nomination and how it literally shut our office down with tens of thousands of phone calls, letters, and faxes. I remember those experiences as we struggle to get a few dozen cancer advocates to contact their members of Congress on issues related to research.
And then it hit me. The difference between those volatile political issues and cancer is simple. We choose the political issues that interest us. Cancer chooses us. Getting cancer is not a political act. But the next two days will show that if we are serious about finding a cure for the various cancers that afflict us, we must be political. We must be political because it is through federal funding that we will accelerate research funding in meaningful amounts. And One Voice Against Cancer is the only broad-based cancer research funding coalition that articulates the needs of the entire cancer community.
One Voice Against Cancer Priorities
One Voice focuses its advocacy on funding for cancer research programs at the National Institutes of Health (NIH), the National Cancer Institute (NCI), the National Center for Minority Health and Health Disparities (NCMHHD), and the Centers for Disease Control and Prevention (CDC). Regulatory and other funding issues important to the members of One Voice can, and will, still be important to their respective agendas, but will not be included in that of One Voice. In this coalition, we focus on specific cancer research appropriations; stated more simply, we focus on the money.
As we all learned in our civics classes, Congress can authorize anything it wants—and it usually does to give the illusion that something is being done. Appropriations—funds released to be spent—are action. If it ain't appropriated, it ain't going to happen.
The National Institutes of Health: Continue the Process to Double Funding
The focus of federally supported medical research is the National Institutes of Health (NIH). In theory, NIH has the authority to conduct basic medical research affecting virtually every known disease and disability. Many NIH researchers are based at its Bethesda, Maryland campus, but most research funding is awarded to institutions throughout the U.S. and the world. If there is a medical research facility in your area, chances are good that it is receiving funding through a number of NIH grants. NCI estimates that 85% of its budget is spent at research facilities throughout the nation.
Congress has repeatedly demonstrated support for NIH funding as a national priority over the past decade. Beginning with the fiscal year 1999 funding cycle, Congress began a process to double the NIH budget within five years. After last year's appropriations bills were signed into law, Congress and the President achieved $23.7 billion needed to fulfill the fourth year of the five-year doubling pledge. This year, President Bush included $27.3 billion for NIH in his annual budget—the amount needed to fulfill the five-year pledge.
The National Cancer Institute: The Bypass Budget—An Untapped Opportunity
Founded thirty years ago as the centerpiece of the nation's War on Cancer, NCI is the largest of the NIH institutes. Significant funding has flowed to NCI within the past decade, due first largely to the activism of the breast cancer advocacy community. Congress appropriated $4.2 billion for NCI in fiscal year 2002. But despite its resources—which are significant—NCI still has not achieved, on a fiscal level, the type of funding the educated scientific community feels is needed to fully address current and future research opportunities.
NCI is required, under the National Cancer Act (P.L. 92-218), to submit an annual Bypass Budget prior to the submission of the President's budget to Congress. This statutory requirement to submit a forward-looking budget is unique among all federal medical research institutes. The term bypass refers to the fact that, unlike all other federal agencies, the recommendation goes directly from the NCI Director to the President—bypassing the normal chain of bureaucracy which includes, among others, the Secretary of Health of Human Services and the Office of Management and Budget. The Bypass Budget is the NCI Director's best fiscal estimate of the cost needed to fulfill the legal mandate to provide the national cancer research program with the technology and investment it needs.
Neither Congress nor the President has, however, fulfilled this request through the appropriations process. Considering that NCI funds about 28% of its approved grants, it doesn't take much of a stretch to understand what significant funding increases to achieve the Bypass Budget could potentially do to find better treatments and cures.
Since the inception of the Bypass Budget thirty years ago, there has been a consistent gap between the actual amount appropriated by Congress for NCI as compared to the Bypass Budget request. For example, in fiscal year 2001, the NCI Bypass Budget recommendation was $4.1 billion and the final amount approved was $3.8 billion. In fiscal year 2002, the NCI Bypass Budget figure was $5.03 billion, but the final amount was $4.2 billion. For this year's fiscal year 2003 budget, the NCI Director recommended of $5.69 billion, which, if approved, would be an annual increase of almost $1.5 billion.
Funding the Bypass Budget offers the best chance for Americans who will be newly diagnosed with cancer and for the millions who are currently living with cancer. Fully funding the Bypass Budget also offers hope to those Americans who will be diagnosed with rarer, deadly forms of cancer that still lack early detection tools or treatment options.
Unfortunately, it can be argued that a wink-and-a-nod understanding exists between Congress and cancer advocates that the Bypass Budget number is an unattainable ceiling for NCI spending. Cancer advocates should be happy with anything they get, because it's more than most others, or so the general argument goes. Incredibly, most congressional staff, especially those on the committees with an interest in NCI, know-little-to-nothing about the Bypass Budget. Until they do, there can be little hope of a revolutionary change in cancer research at the federal level.
The National Center for Minority Health and Health Disparities: Reducing the Unequal Burden of Cancer
Among the unknown and little understood phenomena about so many forms of cancer is the fact that minorities and underserved communities are disproportionately contract the disease. For example, black Americans are at highest risk among the general population to be diagnosed with multiple myeloma. The average incidence rate of myeloma among black Americans is more than twice that of the general population. Moreover, as with all statistical groupings, black Americans become more susceptible to myeloma as they age, only more so. No reasonable studies exist to explain this difference.
The same trends can be applied to most cancers. Similar disparities exist among various diseases affecting minorities including Hispanics, Native Americans, and the Inuit populations of Alaska. While not generally recognized as such, rural populations and women also fall under the categories of the medically underserved. They are also less likely to participate in clinical trials and are underrepresented in the health professions and among research scientists.
Recognizing the need to combat existing disparities in health care, in 2000 a bipartisan majority in Congress supported the establishment of the NCMHHD to coordinate and advance health disparities research across NIH (P.L. 106-525). While the Center provides research and support on all chronic diseases, One Voice is especially interested in its important work on cancer. NCMHHD works with NCI to expand the cancer research infrastructure by supporting minority serving institutions and NCI Comprehensive Cancer Centers, expanding outreach to populations facing disparities in cancer services, and supporting scientists working to close the gap in disparities and expand the science base for understanding cancer in underserved communities.
The Centers for Disease Control and Prevention: Applying What Works
CDC is the applied side of federal medical research infrastructure. It works to implement congressional mandates to apply research and education into public health initiatives. CDC is also the chief investigative federal agency on public health issues. For example, most of us know about CDC because of its work in the area of infectious diseases and AIDS. But for the cancer community, CDC is an untapped resource. Part of the reason is based on funding, and part is based on science. This year's CDC budget is more than $4 billion, but less than $260 million will be expended on cancer prevention and control programs.
One Voice currently advocates for seven CDC programs addressing cancer research: the Comprehensive Cancer Control Initiative, the National Cancer Registries Program, Colorectal Cancer Screening, the Prostate Cancer Awareness Campaign, the National Breast and Cervical Cancer Early Detection Program, the Skin Cancer Prevention Program, and the Ovarian Cancer Awareness Program. The focus on specific cancer programs in CDC appropriations occurs because, unlike NIH and NCI, CDC will not engage in an activity without specific directives from Congress. One Voice's requests for CDC cancer programs will change since Congress will likely earmark funding for new CDC programs in the future.
For example, both the House and Senate reports to the FY 2002 Labor, HHS, and Education appropriations bill contain the following language under CDC:
The Committee encourages CDC to plan and implement public awareness programs for orphan cancers for patients and physicians. Such cancers include esophageal, kidney, liver, multiple myeloma, pancreatic and stomach. Patients diagnosed with these cancers have the lowest life expectancy rates of all diagnosed cancers, yet community oncologists generally lack specific knowledge about these malignancies. Public awareness programs would help physicians better identify orphan cancer symptoms and make more accurate, timely diagnoses.
As the science of cancer detection and prevention advances through increased research, CDC will play in integral role disseminating and applying state-of-art therapies and education to fulfill its public health mandate, but it must be given the resources to fulfill its public health mandate for all cancer patients. It will be up to the grassroots to determine how those policies will be implemented.
Senators Cochran, staffer Bettilou Taylor, Senator Specter, Senator Harkin
responding to OVAC testimony
How Congress Engages in Cancer Research Funding
Why does One Voice not advocate for disease-specific funding? The answer is because Congress does not appropriate funds for specific medical research programs, projects, specific diseases, or cancers. Instead, Congress appropriates lump sums of annual funding to the NIH and its respective institutes and grants their directors the discretion to exercise their judgment based on scientific opportunity.
How then, does Congress make its intentions known about its desires and wishes with respect to particular diseases and programs? It engages to the various agencies and institutes through directive report language that accompanies appropriations bills. These congressional recommendations, contained in reports produced separately in the House and Senate, provide markers and standards to measure the performance of each research institute. Members of Congress assist the process through letters of inquiry to the agencies and House and Senate appropriations hearings featuring the particular agencies or departments under scrutiny. This process is continuous.
Confusion about this process is accentuated when funding figures for specific disease categories are made public. NIH generates these figures after the budgetary year. The numbers are based on knowledgeable estimates of the previous year's research. Congress does not dictate these funding figures to NIH. Congress does, however, rely on the institute-provided figures as benchmarks for progress in specific areas, including disease categories, and as a guide for future institute funding recommendations.
This was stated unequivocally in the last year's House report to the Labor, HHS, and Education appropriations bill (H. Rept. 107-229):
"Balance in the Research Portfolio - The Committee believes that NIH should distribute funding on the basis of scientific opportunity... The Committee urges the Director and the Administration to continue to resist pressures to earmark, set-aside and otherwise politicize these invaluable resources...
"To enhance NIH's flexibility to allocate funding based on scientific opportunity, the Committee has attempted to minimize the amount of direction provided in the report accompanying the bill. For example, there are no directives to fund particular research mechanisms, such as centers or requests for applications, or specific amounts of funding for particular diseases." (emphasis added)
However, the intricacies of the process should not blur the objectives of One Voice for full funding for medical research programs at NIH, NCI, NCMHHD, and CDC. Only substantive funding will keep the congressional reports from becoming debating documents.
The New Paradigm: Translational Research and the Advent of Genomics
One Voice believes that fulfillment of its funding recommendations is the most immediate way to support NCI Director Andrew von Eschenbach's emphasis on the New Paradigm for cancer research. The New Paradigm focuses on expanding translational research—applying discoveries in the lab toward more immediate and direct applications for patients. The New Paradigm also puts more emphasis on the most promising, state-of-the-art research of genomics—drugs and therapies that target and treat cancer at the molecular level.
The traditional way of thinking about cancer treatment has been "search and destroy" which is best exemplified by chemotherapy. In plain English, these therapies try to kill cancers with toxic drugs with the hope that enough healthy cells survive the process to maintain the continued health of the patient. As too many of us know, some of these treatments often cause side effects as bad as or worse than the disease itself.
The New Paradigm, which replaces the "search and destroy" mindset with "command and control," demonstrated with drugs like Gleevec for chronic myelogenous leukemia, Iressa for lung cancer, or Herceptin for breast cancer, targets the molecular mechanisms that trigger growth of cancers without debilitating or destroying healthy cells, organs, or systems. The new genomic drugs have proven to be successful in diminishing—or eliminating—many side effects of treatment. Moreover, they have the potential for increasing long-term survival and enhancing quality of life for people living with cancer.
When we look at cancer through the genomic lenses of the New Paradigm, molecular targets will not be conveniently categorized by body parts or tumor types. The key is to identify, through research, the targets that trigger the malignant growth of cancer cells. For many cancer types, there may be dozens, if not hundreds, of targets to be identified. And some of the targets for certain cancer types, at the molecular level, may look more like other cancer types.
For example, hematological cancers like myeloma or leukemia may actually consist of hundreds of subtypes with different targets. And some of these targets may have more in common with differing targets in other cancers—lung, colon, kidney, or pancreatic—than other hematological cancers. This investment is also required to enable NCI's expansion of its research initiatives in the area of less frequently occurring, deadly cancers.
Fulfillment of the One Voice recommendations would provide resources for a New Paradigm linking federal support to the translational research needed to produce the drugs and therapies for all cancer patients. Moreover, the future of the cancer research would not be dictated by trying to carve out turf for particular cancer disease categories.
It would, instead, ensure that all cancer types are represented in the new research and create a logical, transparent system of cancer research leading down a path from incurable condition to chronic, manageable disease to, ultimately, cures for all cancer types. It would provide the framework to encourage cancer researchers to focus more on molecularly targeted therapies. It would allow NCI to engage in programs to explore research initiatives in the smaller, deadlier cancers that have few market incentives to develop new drugs and therapies. This molecular approach is indeed the ultimate expression of "a rising tide lifting all boats."
Obstacle 1: The Arrogance of Diagnosis
Unfortunately, there exists a mindset among certain advocates that some boats are more worthy of rising than others. I call this attitude the arrogance of diagnosis. It is characterized, in my view, by a myopic, disease-centric view of the political world and seems to be most strongly held by individuals who are personally affected by a particular disease or type of cancer. Moreover, it leads to a counterproductive advocacy built on narrow parochialism.
For the benefit of the soccer moms and dads in the audience, the arrogance of diagnosis leads to a situation analogous to the bumblebee soccer you see your youngest children play. In bumblebee soccer, the swarm of players blindly chases the ball around the field, changing direction abruptly with the quirky bouncing of the ball. Every now and then, the chaos leads to the ball somehow falling into the goal—and not always the right one.
Cancer advocates who believe their form of the disease—or their affiliated organization's story about the disease—is more important than others are particularly prone to this activity. (I am always amazed by the phenomena of persons who are diagnosed with rare, relatively unknown types of cancer—who hear the word when they are told they have it—who then become indignant when they learn so little research or federal support goes into that disease. Where were they before they were diagnosed?) So rather than educate themselves about issues like the Bypass Budget and the consistent gap between it and the actual funding levels, they try to advocate for more research funding for their cancer alone.
At the political leadership level, it leads to illusory political symbolism that either leads to little substantive action or the exacerbation of existing inequities. In many ways, that is exactly what is going on at the political level with federal cancer appropriations. Since it is so difficult to get new federal medical research initiatives started, most cancer advocacy focuses on raising funding for disease-specific research. But that is misplaced advocacy. As was explained earlier, Congress does not appropriate funds for specific diseases at NIH. It does so in an attempt to limit the politicization of medical research. While it is imperative for policy makers to understand the variety of diseases we call cancer, they should not be bogged down in making research decisions in the political arena. Or so the theory goes.
The best argument against the arrogance of diagnosis—there are, depending on the method used for categorization, as many as 400 different forms of cancer—is One Voice's agenda. The alternative is a continued politicization of the cancer appropriations process. And there is one more question to ask those who are fixated on increasing research in one area at the expense of others: What if your loved one is diagnosed with a different cancer than that for which you are passionately advocating?
Obstacle 2: Silos
Gov. Roy Barnes (D-GA) articulated the second great obstacle at the May 2001 National Dialogue on Cancer meeting. According to Gov. Barnes, who is among the most progressive and visionary policy makers on state cancer issues, in dealing with the cancer community, he continuously has to overcome what he calls "silos" when trying to implement cancer policy. He defined silos as the funding and policy advantages that each cancer group seeks to gain for its constituency.
As each group works to build its own silo, growth in one often comes at the expense of another. Or at least that is the perception by some. The more we become vested in building our particular silos, the less we get accomplished. At the federal level, one way it translates is in the comprehensive manner in which the Bypass Budget is ignored by policymakers and advocates.
The mentality behind the silo building help to make cancer advocates their own worst enemies. Far too often, individual disease advocates become mired in the minutia of their own limited agendas at the expense of bigger ideas. But if they achieved the bigger ideas, each of their constituencies would have benefited more than under the status quo. This helps policy makers ignore comprehensive issues like the Bypass Budget. And it explains why so few in the community will talk the talk about the Bypass Budget.
This year the National Cancer Institute will spend almost $4.2 billion on cancer research. To compare, the American Cancer Society, the largest cancer research funding organization in the world, will invest more than $100 million over the same period. And one of the most visible advocacy organizations, the Susan G. Komen Foundation for breast cancer research, has raised more than $240 million since its inception in 1982. Compare those numbers to the annual amounts appropriated to NIH, NCI, and CDC. The inescapable conclusion is that federal advocacy which maintains and raises funding for these agencies can return significantly more to the cancer research community than might be apparent at first glance.
As was stated above, realization of the five-year doubling pledge will lead to at least a $27.3 billion NIH budget in fiscal year 2003. According to the latest figures available provided by the industry trade association, the pharmaceutical industry reinvests about roughly 18% of U.S. sales into research and development, which translates to $18.4 billion, $19.9 billion, and $23.8 billion for the respective years of 1999-2001. These are gross figures reflecting a significant investment into medical research. In terms of cancer funding alone, private investment is similar to the NIH and NCI ratio. Remember the likely fiscal year 2003 NIH budget of $27.3 billion should mean about $5.1 Billion for NCI. And as optimistic as those numbers are, for NCI they will still be about $500 million less than the Bypass Budget recommendation.
These numbers demonstrate why political advocacy for the One Voice agenda is as important a task for cancer advocates as our many other activities. While our respective organizations annually raise cumulative millions for research, our federal government appropriates annual billions for cancer research agencies and institutes. But as we engage in community fundraisers for research and programs, let us also commit at least as much time and effort to educate our members of Congress about the value of allocating our fair share of tax dollars into cancer research.
As you can see, One Voice has big plans. If realized, they could signal a new direction in the War on Cancer. Central to the agenda is the Bypass Budget. New research initiatives could potentially be funded by the discrepancy of the amount noted between actual NCI appropriations and the recommendations in the Bypass Budget. Without those increases, they are unlikely to achieve the promise of the New Paradigm.
Achievement of the One Voice agenda would allow all in the cancer community to think big; to realistically dream of what could be. It would allow cancer researcher to focus more on molecularly targeted therapies. It would allow NCI to engage in, for lack of a better term, loss leader programs. These types of programs could explore research initiatives in the smaller, deadlier cancers that have few market incentives to develop new drugs and therapies.
The key to create a pool of significant federal funding for cancer research, and especially for the deadliest cancers will be found, in my view, in the willingness of their representative advocacy groups to ally with each other and promote agendas for other cancers with similar experiences.
This session was quite pompously named The Cancer Landscape. If you will indulge me at the end of this discussion, I'd like to digress somewhat with a metaphor. Since September 11, we have all grown to realize how truly beautiful the Manhattan skyline was and is. Even those of us who never had a good thing to say about New York City have looked at the pictures of the city differently. Those of us who thought those glass box skyscrapers were the ugliest things that man could devise have to now admit: those Twin Towers were beautiful.
I thought about this after reading The Power Broker, Robert Caro's epic study of Robert Moses and the story of how he remade the landscape, for better or worse, of New York City. Thankfully, Moses lost a few battles. The first he lost was his attempt to build a Brooklyn-Battery Bridge that would have stretched from the southern tip of Manhattan across the East River to Brooklyn. Had it been built, those beautiful views of Manhattan we have become so familiar with since September 11 would have been scarred by a monstrous bridge on the southeastern side of the island. Instead they built the Brooklyn-Battery Tunnel, and thus preserved the open view of Battery Park and maintained the integrity of seeing Manhattan as an island.
In my opinion, this story is analogous to what is going on as we try to develop the big picture of cancer research. Not that there is anything beautiful about it. It becomes uglier and more chaotic as certain advocates try to build silos haphazardly in misguided attempts to find cures for "their" cancer. And by doing so, they obstruct the good work of building a coherent, compassionate, and logical landscape. We should learn from the lesson that those involved in the rescues and recoveries of the September 11 taught us. We should learn that if we all step back, take in the scenery, speak with one voice, and look each other honestly in the eyes, that we can find common ground and build something of beauty that we can be proud of. We can conquer cancer. But we cannot let selfishly built silos get in the way of our real mission. That is why we must speak with One Voice Against Cancer.