Mr. President, I rise today to introduce the National Cancer Act of 2003. I am pleased to have the support of Senators Smith, Daschle, Jeffords, Kennedy, Collins, Landrieu, Hutchison, Johnson, Corzine, Lincoln, Clinton, Cantwell,…
Mr. President, I rise today to introduce the National Cancer Act of 2003. I am pleased to have the support of Senators Smith, Daschle, Jeffords, Kennedy, Collins, Landrieu, Hutchison, Johnson, Corzine, Lincoln, Clinton, Cantwell, Lautenberg, Murray, Dodd, Boxer, Stabenow, Bill Nelson, Schumer, Hollings, Reed, Kerry, Mikulski, and Leahy on this important piece of legislation.
Today, cancer is the Nation's second cause of death, trailing heart disease. Over the next 30 years, however, cancer will surpass heart disease and become the leading cause of death as the Baby Boomers age.
This bill represents a comprehensive national battle plan to re- energize the Nation's war on cancer, a war that began on January 22, 1971 when President Richard Nixon proposed to Congress that we launch a war on cancer.
That commitment marked a critical first step. But it is clear that we must take further steps to address the scourge of cancer in every respect.
I am the Vice-Chair of the National Dialogue on Cancer--and in discussions with cancer experts from this group, it became clear to me that the National Cancer Act of 1971 was out of date.
We are now in the genomic era, on the cusp of discoveries and cures that we could only have dreamed about in 1971. The science of cancer has advanced dramatically with the revolution in molecular and cellular biology creating unprecedented opportunities for understanding how genetics relate to cancer.
The explosion in knowledge about the human genome and molecular biology will enable scientists to better target cancer drugs.
I believe that if we work smart we could find a cure for cancer in my lifetime.
Given these advances, I strongly believe that it is time to update the National Cancer Act of 1971, to reflect these breakthroughs. At the same time, I wanted to get input from some of the nation's foremost cancer experts.
To that end, I asked John Seffrin, CEO of the American Cancer Society, and Dr. Vincent DeVita, Director of the Yale Cancer Center, to form a special committee of cancer experts to provide recommendations on a national battle plan to conquer cancer.
The committee produced an ambitious plan, and what I have tried to do is take the most important components, in light of the current budget
situation, and develop a piece of legislation that could pass the Senate.
On November 7, 2001, President George W. Bush commended the work of the Committee when he wrote, ``The journey ahead will not be easy. But 30 years ago, no one would have imagined coming as far as we have. Working together, we will take the next steps necessary to defeat this deadly disease.''
Today, I invite the President to join me again in taking these steps by supporting this legislation.
Finding a cure for cancer is a very personal goal. I lost both my father and my husband to cancer. I saw its ravages firsthand, and I experienced the frustrations, the difficulties, and the loneliness that people suffer when a loved-one has cancer. I determined that I would do all I could to reduce the number of people who go through this devastating experience.
And it is my great hope that this legislation will help do just that, and enable us to find a cure for cancer in my lifetime.
This may in fact be the most important thing I do during my time in the Senate.
And I believe that this legislation addresses the issue in the right way, and I hope that my colleagues will agree.
The National Cancer Act of 2003 takes a multi-pronged approach to winning the war against cancer. Here's what the bill will do: 1. Accelerate Scientific Discovery. The advances in science that I spoke of earlier, regarding the human genome and molecular biology, have produced medications that can target the unhealthy cancer cells and leave healthy cells intact.
That is why this legislation establishes a grant program of $20 million a year, specifically for research that focuses on the development of a molecularly-oriented knowledge-based approach to cancer drug discovery and development.
It also includes a sense of the Senate to encourage the Federal Government to continue its investment in cancer research by staying on track to funding the NCI bypass budget.
NCI now funds approximately 4,500 research project grants at nearly 600 institutions every year. This represents 28 percent of the 16,000 grant proposals NCI receives. NCI scientists think funding 40 percent will allow them to fund the most promising grants. Yet at 28 percent, it does not happen.
Funding basic research marks a full frontal assault on cancer--an assault that will lead to more breakthroughs, more treatments, and ultimately, I believe, to a cure.
We now have drugs, like Gleevec for Chronic Myeloid Leukemia and Herceptin for breast cancer, that can target and destroy cancer cells while leaving healthy cells unharmed.
Patients, who were considered terminal, have taken Gleevec and were able to get out of their beds and leave the hospice within days of treatment. After one-year of clinical trials for Gleevec, 51 out of 54 patients were still doing well. With 4,500 Americans diagnosed with Chronic Myeloid Leukemia a year, the potential for this drug is tremendous.
From the Bench to the Bedside: Expanding Access to Clinical Trials. First, the bill will provide $100 million per year for new grants for what is called ``translational'' research, work that moves promising drugs from the ``bench to the bedside.''
The purpose of this provision is to greatly accelerate the movement of basic research to the patient, from the ``bench to the bedside,'' so that we can conduct more clinical trials.
Clinical trials test the safety and efficacy of drugs, devices or new medical techniques. They are required for FDA approval. These trials require thousands of participating people to help determine if drugs are safe and effective.
The bill includes several steps to expand clinical trials, those research projects that require thousands of people to determine whether new drugs are safe and effective.
Right now, there are many new drugs under development that are stuck, as if in a funnel, because we have not put the resources into having the people-based research to test those drugs. There are approximately 400 new drugs that are held up in the development process because the resources are not available to fund clinical research to test those drugs.
For every one drug approved, 5,000 to 10,000 were initially considered. The entire process can take as long as 15 years.
Second, the bill will require insurers to pay the routine or non- research costs for people to participate in clinical trials, while the drug sponsor would continue to pay the research costs. California already requires this coverage by private insurers.
Third, the bill requires the National Cancer Institute to establish a program to recruit patients and doctors to participate in clinical trials. Dr. Robert Comis, President of the Coalition of National Cancer Cooperative Groups, has said that eight out of ten cancer patients do not consider participating in a clinical trial. They are unaware that they might have the option. He has found that physician involvement is key.
This is why we must work to make both physicians and patients more aware of the importance of participating.
Currently, only 4 to 5 percent of adult cancer patients participate in clinical cancer trials. But Research America polls found that 61 percent of Americans would participate in a clinical trial if they could.
We should heed the example of what is called the ``pediatric model.'' Over 60 percent of children with cancer participate in clinical trials. Children in these trials get optimal care, with an overall physician manager or ``quarterback.'' The five-year survival rates for children with cancer have increased significantly.
In the 1960s, childhood leukemia could not be cured. It was a death sentence. Today, 70 percent of children with acute lymphoblastic leukemia enter remission. This is but one example of the power and importance of clinical trials. An investigational treatment yesterday is standard treatment today.
Only by injecting new funding into cancer research will we enable cancer researchers to conduct the trials that are necessary to bring promising new drugs to market.
3. Transforming Research Into Treatments. Scientists say we will stop defining cancer by body part, like breast cancer or prostate cancer. Because everyday we are understanding better the genetic basis of cancer and can focus drugs on molecular targets. For example, we may have 50 different kinds of breast cancer, defined by their genetic basis.
As NCI's Dr. Rabson has said, ``As we've come to understand the molecular signatures of cancer cells, we can classify tumors according to their genetic characteristics.''
This means that we need to create incentives to encourage companies to make these targeted drugs, because as we redefine cancer, we will have smaller numbers of people who have that particular kind of breast cancer. Companies are often reluctant to make drugs for small patient populations.
This legislation would expand the current definition of ``orphan drugs'' from ``disease and condition'' to include ``disease or condition or targets and mechanisms of pathogenesis of diseases'' that effect a small patient population, less than 200,000. Current tax and marketing incentives remain the same. With an expansion of the definition, however, more drugs could potentially qualify for this designation.
Beginning with Gleevec and continuing into the future, drugs will target a narrow genetic or cellular mutation.
While this holds great promise for patients, it also means that the number of treatments will proliferate, thereby segmenting cancer patients into smaller and smaller populations. In some cases, this will mean that pharmaceutical companies for strictly financial reasons may not want to produce a given drug.
The impact: This will help to ensure that patients receive the highest quality care, even when the number of people faced with a particular type of cancer is small.
4. Having Enough Scientists. The bill will also create a new initiative to train more cancer researchers. Specifically, it will: 1. Pay off the medical school loans of 100 physicians who commit to spend at least 3 years doing cancer research; and 2. Boost the salaries of postdoctoral fellows from $28,000 to $45,000 per year over 5 years.
Every year, young physicians and researchers avoid the field of cancer research because, frankly, they feel they can make more money elsewhere. This provision will help reverse that trend and add thousands of men and women to the front lines of the fight.
The physician-scientist is endangered and essential, concluded a January 1999 study, showing that the number of first-time M.D. applicants for NIH research projects has been declining. The study, published in Science, said, ``. . . fewer young M.D.'s are interested in (or perhaps prepared for) careers as independent NIH-supported investigators.''
Simply put, young doctors and Ph.Ds do not want to go into cancer research because they can make more money elsewhere. Graduating physicians have medical school debt averaging $75,000 to $80,000. Because of the low pay to be a physician-scientist, these doctors cannot afford to go into research.
Postdoctoral fellows, who conduct the bulk of day-to-day research, receive pay that is neither commensurate with their education and skills nor adequate. To attract the best and the brightest to the field of cancer research, we need to pay them more than $28,000 to start.
The National Academy of Sciences in September 2000 called for increasing their compensation.
5. Quality Cancer Care. All too often having cancer is a lonely and frightening experience. Cancer patients have a team of doctors, from the primary care physician to the radiologist to the oncologist. Yet patients need one doctor to be in charge.
During a June 16, 1999 hearing, The Institute of Medicine told the Senate Cancer Coalition that the care that cancer patients get is all too often just a matter of circumstance: ``. . . for many Americans with cancer, there is a wide gulf between what could be construed as the ideal and the reality of [Americans'] experience with cancer care . . . The ad hoc and fragmented cancer care system does not ensure access to care, lacks coordination, and is inefficient in its use of resources.''
The Institute of Medicine study on the uneven quality of health care says, ``Health care today is characterized by more to know, more to manage, more to watch, more to do, and more people involved in doing it than at any time in the nation's history.''
The bill will require insurance plans to pay doctors, preferably oncologists, to become the overall managers of patients' care, what I call a ``quarterback physician,'' to be with the patient from diagnosis through treatment, to prevent the patient from being forced to navigate the medical system alone.
I developed this concept after meeting Dr. Judy Schmidt, a solo- practicing oncologist from Montana. Dr. Schmidt cares for her patients from diagnosis to treatment, and she is really a model for doctors across the Nation to emulate.
This ``quarterback physician'' would provide overall management of the patient's care among all the providers. Someone would be in charge. This provision could save money because good coordination can reduce hospitalization costs.
The bill authorizes grants to health centers for the development and operation of programs that assign patient navigators, nurses, social workers, cancer survivors and patient advocates, to individuals of health disparity populations, to assist in following-up on a cancer diagnosis and to help them find the appropriate services and follow-up care, which includes facilitating access to health care services.
This program is important because many people receive unequal access to care. The Institute of Medicine issued a report last year called Unequal Treatment: Confronting Racial and Ethnic Disparities in Health Care. This report emphasized the importance of ``providing advocates for patients who can assist them in asking the appropriate questions, and making the necessary inquiries as they access the health are system . . . ''
Often these are patients without health insurance who are not fluent in English. Having a culturally appropriate ``navigator'' who will assist them in making appointments and understanding the services available to them could help improve quality of life for minorities.
Lastly, the bill also authorizes grants through the Centers for Disease Control and the National Cancer Institute to monitor and evaluate quality cancer care, develop information concerning quality cancer care and monitor cancer survivorship.
6. Coverage of Preventive Measures. People cannot get good health care if they have no way to pay for it, if insurance plans, public and private, do not cover the basics like screenings for cancer.
My bill will require public plans, like Medicare and Medicaid, and private insurance plans to cover four services important to good cancer care: 1. Cancer screenings; 2. Genetic testing and counseling for people at risk; 3. Smoking cessation counseling; and 4. Nutrition counseling.
Access to mammograms, pelvic exams, along with reducing fat in the diet and stopping smoking--all of which could be enhanced by this bill--can stop cancer before it is too late.
Because too many Americans have no way to pay for their health care when cancer strikes and because seven percent of cancer patients are uninsured, the bill also requires the Institute of Medicine of the National Academy of Sciences to conduct a study of the feasibility and cost of providing Medicare coverage to individuals at any age who are diagnosed with cancer and have no other way to pay for their health care.
Medicare already covers care for people of any age who have End Stage Renal Disease and Amyotrophic Lateral Sclerosis, Lou Gehrig's Disease. This study could provide helpful guidance to the Congress.
Because no assault on cancer is complete without a strong cancer prevention component, the bill provides funds and requires the Centers for Disease Control and Prevention to prepare a model state cancer control and prevention program; expand the National Program of Comprehensive Cancer Control plans, and to assist every state to develop a cancer prevention and control program.
The bill also authorizes $250 million to expand the Center for Disease Control and Prevention's breast and cervical cancer screening program and authorizes $50 million for CDC to begin screening programs for colorectal cancer.
7. Bolstering the Number of Health Care Providers. Because of the aging of the American population, we face a virtual explosion of cancer in the coming 30 years. The number of cases will double. But the sad fact is that we do not have enough nurses and other health care professionals to take care of this expected rise in cancer patients.
My bill will provide $100 million for loans, grants and fellowships to train for the full range of cancer care providers, including nurses for all settings, allied health professionals, and physicians. The bill requires that these applicants have the intention to get a certificate, degree, or license and demonstrate a commitment to working in cancer care.
In nursing alone--those critical people on the front line of care-- many experts say we face a national nursing shortage in virtually every setting, which will peak in the next 10 to 15 years unless steps are taken. By 2020, the RN workforce will be 20 percent short of what will be needed. My home State of California ranks 50th among registered nurses per capita.
And it's not just nurses. The Health Resources Services Administration says that the demand of health care professionals will grow at twice the rate of other occupations.
Cancer is primarily a disease of aging. As the baby boomers age, there will be more cancer. Cancer care is becoming more and more complex as technology improves. Skilled providers, from the nurse assistant to the oncologist are needed to administer the complex therapies. This bill should provide some help.
8. Cancer Survivorship. Thanks to advances in cancer detection and early diagnosis, more aggressive and effective treatments, and better screening tools, about 9 million Americans--nearly one in 30--can call themselves a cancer survivor. This represents 3 percent of the population.
Thirty years ago a cancer diagnosis was a death sentence. That is not the case today. As a result, addressing a person's quality of life post-cancer is becoming increasingly important.
To give you a snapshot picture of what a typical cancer survivor looks
like: about 59 percent of cancer survivors are over the age of 65; 3 million (30 percent) were diagnosed between 5-15 years ago; and, 23 percent are breast cancer survivors and 17 percent are prostate cancer survivors.
Current statistics suggest that for individuals who receive a diagnosis today, 60 percent can expect to be alive in 5 years. The 5- year survival rate for children is even higher--almost 75 percent.
What this means is that more than half of all people, children or adults, diagnosed with cancer today, will become cancer survivors.
We've come a long way. And the survival rate for cancer will only get better as we continue to make improvements in screenings, detection, diagnosis and treatment.
But now we face new challenges. We need to better understand what services are necessary to help address the needs of people who are surviving cancer.
This bill would do several things to help support cancer survivors.
First, it would codify an Office of Cancer Survivorship at NCI. Since 1999, such an Office has been in existence but it has not been officially recognized by Congress or received it's own budget.
This Office is crucial because it sets the research agenda at NCI on survivorship-related issues.
The National Cancer Institute found in 1999 that ``surviving cancer can leave a host of problems in its wake. Physical, emotional, and financial hardships often persist for years after initial diagnosis and treatment. Many survivors suffer decreased quality of life following treatment, leading one cancer activist and survivor to say, `surviving is not just about a cure, but about living the rest of our lives.' ''
For some, long-term health problems result, for example, because a surgery to remove a cancer tumor has impaired nearby organs which could cause additional health problems.
Additionally, patients who survive one cancer have almost twice the risk of developing a second cancer as the general population. Almost 100,000 people are diagnosed each year with ``second cancers.'' What can be done to reduce the chance of a second diagnosis of cancer?
And the bill also authorizes grants through the Centers for Disease Control for activities including the development of a cancer surveillance system to track the health status of cancer survivors, and the development of a national cancer survivorship action plan.
For 9 years I have co-chaired the Senate Cancer Coalition. We have held ten hearings on cancer. With each hearing, I become more and more convinced that we can conquer cancer in my lifetime. These are the highlights of the cancer battle plan.
It is my hope that this legislation will become the rallying cry for the Cancer community.
Polls by Research America show that the public wants their tax dollars spent on medical research and that in fact people will pay more in taxes for more medical research.
Cancer impacts everyone. Everyone knows someone who has had cancer or will have cancer.
I am thoroughly convinced that if we just marshal the resources, we can conquer cancer in the 21st century. Let's begin. The road ahead is long and treacherous. But if we all work together, I honestly believe we can do it.