Access to Cancer Therapies Act of 2003

Mr. President, today, I am pleased to join the Senator from Colorado (Mr. Allard) in introducing comprehensive legislation to address the problem of chronic wasting disease. This legislation is similar to legislation we introduced last year, updated to reflect current status of this issue. I am delighted to be continuing my efforts with him on this bill and to again also be working with my senior Senator from Wisconsin (Mr. Kohl) and commend them and their staff for all their tireless efforts.

This disease is a serious problem affecting both wild and captive deer in my home State of Wisconsin. It has spread from Wisconsin to the neighboring states of Minnesota and Illinois. This legislation is acutely needed, as Wisconsin's experience in getting Federal assistance to address this problem, though eventually forthcoming, has been extremely slow and frustrating. The Federal Government must make chronic wasting disease a higher priority, and Congress must provide the relevant federal agencies with the additional funds and authority so that they can do so.

Congress delayed action on this bill in the last Congress, under promises that the Department of the Interior, DOI, and the Department of Agriculture, USDA, would be acting quickly to put together and implement a comprehensive CWD management plan. It has now been nearly a year, and no such plan has emerged. I was successful in getting a provision included in the 2003 Omnibus Appropriations bill calling for the plan to be released no later than May 20, 2003. That deadline is rapidly approaching, and the legislation we introduce today will provide a clear message--CWD must be a priority for the Federal Government and for this administration.

A coordinated approach is needed, due to the severity of this disease, its ability to spread, and our urgent need for information to address it. Chronic wasting disease belongs to the family of transmissible spongiform encephalopathies, TSEs, diseases. TSEs are a group of transmissible, slowly progressive, degenerative diseases of the central nervous systems of several species of animals. Animal TSEs include, in addition to chronic wasting disease, CWD, in deer and elk, bovine spongiform encephalopathy in cattle, scrapie in sheep and goats, feline spongiform encephalopathy in cats, and mink spongiform encephalopathy in mink.

The State of Wisconsin has just completed an historic effort to test the deer in our State. Results from more than 41,000 whitetail deer tested in our State have turned up 207 CWD positive animals. Almost all of the infected deer, 201 of the total, came from a 411 square mile eradication zone of Dane,

Iowa and Sauk counties. My State began intensive testing of deer after CWD was discovered on February 28, 2002. Over 1,200 people in my State have been involved, conducting thousands of hours of work at millions of dollars of expense. CWD has also been found in several captive herds in my State as well.

In that vein, the legislation we are introducing in comprehensive, addressing both captive and wild animals and short term and long term needs. It authorizes a $34.5 million Federal chronic wasting disease program that will be administered by the United States Departments of Interior and Agriculture, USDA. It is similar to legislation being introduced today in the House of Representatives by the Representatives from Colorado (Mr. McInnis), and from Wisconsin (Mr. Green), and was cosponsored on a bipartisan basis by Wisconsin delegation members in the House Of Representatives in the last Congress. I think it is extremely appropriate that legislators from Colorado, the state that has the longest history in chronic wasting disease, have made a concerted effort to work with Wisconsin members who are struggling with a new outbreak. I deeply appreciate the commitment of the Representative from Colorado (Mr. McInnis), toward finding a solution that works for both our States. I think these are good comprehensive efforts, and I would like to highlight a few provisions in detail.

The bill I am introducing with the Senator from Colorado (Mr. Allard), authorizes $16 million for grants to States and tribal governments battling CWD. The Interior Department to give up to $10 million in grants to States to help them plan and implement management strategies to address chronic wasting disease in both wild herds of deer and elk. The Interior Department is directed, in addition, to develop a national chronic wasting disease incident database, building on the existing USDA reporting program. The USDA is authorized to award up to $6 million in grants to those same entities for the management of CWD in captive deer and elk. These amounts are nearly triple $5.6 million that USDA made available to States for use to address CWD in both captive and wild cervids.

I am particularly pleased that the Senator from Colorado (Mr. Allard), has incorporated provisions that I authored to address Wisconsin's ongoing need for enhanced testing capacity to move toward a system of widely available testing for hunters. Under the bill, USDA is required to release, within 30 days, protocols both for labs to use in performing tests for chronic wasting disease and for the proper collection of animal tissue to be tested. USDA is further required to develop a certification program for Federal and non-Federal labs, including private labs, conducting chronic wasting disease tests within 30 days of enactment. I hope all these measures will enhance Wisconsin's capacity to continue its deer testing program. To address longer term needs, the USDA is directed to accelerate research into the development of live animal tests for chronic wasting disease, including field diagnostic tests, and the development of testing protocols that reduce laboratory test processing time.

This bill is needed, because State wildlife and agriculture departments do not have the fiscal or scientific capacity to adequately confront the problem. Their resources are spread too thin as they attempt to prevent the disease from spreading. Federal help in the form of management funding, research grants, and scientific expertise is urgently needed. Federal and state cooperation will protect animal welfare, safeguard our valued livestock industry, help guarantee America's food safety, and protect the public health.

I look forward to working with my colleague from Colorado (Mr. Allard), to seek passage of this measure. This is a good bill and it deserves the Senate's support.

Mr. President, last year, I joined eleven colleagues in an effort to pass legislation that dealt with the eradication, monitoring, and surveillance of chronic wasting disease. Today, I am offering similar legislation, the ``Chronic Wasting Disease Support Act of 2003.'' Before I discuss the legislation further, I first want to thank Senator Feingold for his leadership on this matter and for working diligently to eradicate the disease. I also want to congratulate the State of Colorado, especially those Departments and Divisions that have been on the leading edge of disease management and eradication. They faced a horrendous task--processing tens of thousands of tests on a tight time frame. While more work lies ahead, they are to be commended for their effort.

What was first a serious problem in the western United States, chronic wasting disease now poses a serious threat to every State of the union. As a United States Senator, chronic wasting disease presents not only a great animal health challenge, but a scientific quandary as well. As a veterinarian, chronic wasting disease presents an even greater challenge to the scientific communities of both the States and the Federal Government because we know so little about the disease. This legislation, cosponsored by Senators Feingold, Kohl, Roberts, Campbell, Burns and Craig, is a bipartisan effort to defeat the disease and to send a message that CWD must remain a priority for the Federal Government.

The importance of this bill to both the State and Federal Government cannot be emphasized enough. It authorizes $34.5 million in the battle against chronic wasting disease. Although the bill authorizes a substantial amount Federal funding to fight and eradicate the disease, the States will retain their undisputed primacy and policy-making authority with regard to wildlife management. Nothing in this act interferes with or otherwise affects the primacy of the States in managing wildlife generally, or managing, surveying and monitoring the incidence of chronic wasting disease. It is important that all members of our delegation and in both the House and the Senate, coordinate our efforts as we fight the disease.

Chronic wasting disease, or CWD, may be a new threat to some. Others may not be familiar with it at all. However, it is not new to those of us in Colorado and Wyoming, who have been dealing with it for over twenty years, and if the disease continues to spread, those unfamiliar with the fatal disease will, unfortunately, become experts in CWD policy. The scientific community has gone to great lengths to deal with the disease on limited budgets. These experts, through scientific publication and Congressional hearings, have told us that, although we have learned a tremendous amount about chronic wasting disease, there is much that we do not know and much that we must do to eradicate it.

One thing we do know is that sound science is the answer, and that the Chronic Wasting Disease Support Act of 2003 is intended to greatly increase research, monitoring, surveillance, and management of the disease on all levels. It bolsters testing capacity, diagnostics capabilities, and funding authorization.

Increased research and research funding is necessary because the disease is quite simply a mystery--the origin and transmission of CWD remains unknown. Unfortunately, the only way to treat an animal with CWD or to contain the disease is to destroy the animal and cull the herd. Together, we must embark on an ambitious and sound scientific commitment for research and investigation to end chronic wasting disease. That is what this bill calls for--cooperation and collaboration, working together at both the State and Federal level to achieve a common objective. We must end chronic wasting disease, and we must begin our eradication efforts now.

The impact CWD will have on wildlife and agriculture is undeniable, and the economic and emotional toll of the disease cannot be overstated. Communities that are economically reliant upon deer and elk related enterprises will feel the impact of CWD as concern about the disease grows. But we can stop this, and we must stop this. We have an opportunity to restore cervid health, to contain the disease, and, most importantly, to eradicate the disease. This is the challenge that I urge my colleagues to accept, and to take decisive action; adequate research funding that is directed toward the complete eradication of chronic wasting disease starts with this authorizing legislation.

In those States that are already dealing with CWD, the fiscal demands required to manage the disease is quite apparent. State budgets are stretched thin as they cull wild and captive herds and research for workable solutions to stop the disease. With State budgets already strained, an infusion of Federal resources and technical assistance is required to help the States keep CWD from spreading, to treat infected or exposed populations, and to greatly expand research for testing and possible cures. This bill does just that by providing assistance in the form of grants, Federal research programs and incidence reporting, as well as scientific assistance. State and Federal cooperation will protect animal welfare, safeguard our valued livestock industry, provide relief to family elk ranchers, help guarantee America's food safety, and protect the public health.

The Chronic Wasting Disease Support Act of 2003 provides the foundation for a nationwide increase in diagnostic capabilities. Undoubtedly, the spread of CWD and the increased awareness of the disease, will cause the demand for testing to grow exponentially--this bill helps us prepare to handle a large volume of cases efficiently and reliably. The legislation calls for the development of new testing methods to help us understand the disease, as well as developing a live test.

Chronic wasting disease presents a common problem to the States and the Federal Government. The Federal conduit role that is provided in the bill will allow animal health experts to unravel the CWD mystery. The challenge we face is to achieve what we all recognize as a common objective--to understand CWD and to eradicate it. But, we must act quickly or this disease will redefine the wildlife characteristics of our States.

Thank you, Senator Feingold. I ask unanimous consent that the text of the bill be printed in the Record.

Mr. President, I rise today to introduce, the Access to Cancer Therapies Act, which will extend Medicare coverage for all oral anticancer drugs. This legislation will help ensure that Medicare beneficiaries with cancer have access to the most advanced and effective drug therapies. I am pleased to be joined today by 19 of my colleagues in introducing this legislation. The strong bipartisan support the bill has received, even before introduction, indicates its importance to members of the Senate.

As we know, presently Medicare does not include an outpatient prescription drug benefit. While this is a tremendous hardship for all beneficiaries, it is especially difficult for seniors who have cancer, which prevents them from receiving the most appropriate drug treatments as recommended by their physicians.

Enacting a comprehensive Medicare drug benefit is certainly one of my top priorities. However, even if we are successful and enact a bill into law this year, the comprehensive benefit is not expected to be available until 2006 at the earliest. This bill, on the other hand, would allow Medicare to begin coverage of oral anticancer drugs within 90 days of enactment. These patients are facing life and death choices, I believe it is our responsibility to provide access to the most effective and appropriate drug therapies.

Congress recognizes the importance of expanding coverage to vital cancer treatments and in 1993 created a unique Medicare drug benefit for oral anti-cancer drugs. Unfortunately, coverage under this law only is provided if the drug is equivalent to drugs provided ``incident'' to a physician visit; for example, drugs that must be injected. At present, upwards of 95 percent of cancer drug therapy is covered by Medicare either in a physician office or as an oral form, which qualifies under the 1993 legislation. However, in the very near future as much as 25 percent of cancer drug therapies will be oral drugs not covered. By enacting this legislation into law, we can ensure these new outpatient cancer treatment therapies will be available to Medicare beneficiaries.

This is a developing trend. Today, there are about 40 oral anti- cancer drugs, but less than 10 are reimbursed by Medicare. In fact, one of the most common and effective drugs used in the treatment of breast cancer, tamoxifen, is among those drugs that currently are not reimbursed by Medicare.

As cancer therapy becomes more reliant on oral drugs, Medicare coverage policy must be updated to cover the new therapies. Otherwise the intent of the very limited 1993 policy will become meaningless and Medicare beneficiaries will increasingly lose access to the best cancer therapies.

Let me provide some very encouraging examples of oral anti-cancer drugs that illustrates the urgency of both this policy change and of enacting Medicare prescription drug legislation. Over the past two years, the FDA has approved a number of remarkable oral anticancer drugs that are producing outstanding results. Two such examples include Gleevec, which was approved in 2001 and IRESSA, which was approved on May 5.

Gleevec is used to treat one type of leukemia and may also be effective against a rare but lethal stomach cancer. It is the first, let me repeat, first, cancer drug to specifically address a molecular target, which not only is in the cancer, but actually is the cause of the cancer, according to the National Cancer Institute. More precisely, Gleevec eliminates a specific enzyme needed for the cancer to thrive. By contrast, most current cancer therapies act like a shotgun, killing both cancer and normal cells.

IRESSA, another revolutionary oral anticancer drug that the FDA recently approved, treats advanced non-small-cell lung cancer, NSCLC. Considering lung cancer is the leading cause of cancer deaths in the United States, estimated to account for approximately 157,000 deaths in 2003, and NSCLC is the

most common form of lung cancer, accounting for 80 percent of all lung cancer cases, it is imperative that Medicare beneficiaries have access to this new drug. For many who do not respond to chemotherapy treatments, IRESSA is the last line of defense.

However, both of these cancer treatments are expensive. For instance, while Gleevec is a revolutionary and highly effective treatment, it is not a cure. It simply arrests the cancer and returns most lab tests to normal, requiring many patients to take the drug for life. Considering the extraordinary costs of these treatments--a month's supply of Gleevec costs upwards of $2,400 and IRESSA, the last treatment option for many NSCLC patients, costs approximately $1,900 per month of treatment, with the average treatment lasting seven months--Medicare coverage is a necessity.

It is imperative that Medicare provide reliable access to these advanced medications to help beneficiaries with cancer. Biomedical research is providing new, more targeted, and less toxic methods of treatment through new oral anti-cancer drugs that patients can safely take in the comfort of their own homes, which will help improve outcomes and enhance patient quality of life.

We must act now to ensure all oral anti-cancer drugs are available to our seniors. The Access to Cancer Therapies Act will build on current Medicare policy by ensuring coverage of all anti-cancer drugs, whether oral or injectable, are available to Medicare beneficiaries. The Act will provide beneficiaries with access to innovative new therapies that are less toxic and more convenient, more clinically effective and more cost-effective than many currently covered treatment options. I urge my colleagues to support this bill.

Mr. President, I rise today to introduce, the Access to Cancer Therapies Act, which will extend Medicare coverage for all oral anticancer drugs. This legislation will help ensure that Medicare beneficiaries with cancer have access to the most advanced and effective drug therapies. I am pleased to be joined today by 19 of my colleagues in introducing this legislation. The strong bipartisan support the bill has received, even before introduction, indicates its importance to members of the Senate.

As we know, presently Medicare does not include an outpatient prescription drug benefit. While this is a tremendous hardship for all beneficiaries, it is especially difficult for seniors who have cancer, which prevents them from receiving the most appropriate drug treatments as recommended by their physicians.

Enacting a comprehensive Medicare drug benefit is certainly one of my top priorities. However, even if we are successful and enact a bill into law this year, the comprehensive benefit is not expected to be available until 2006 at the earliest. This bill, on the other hand, would allow Medicare to begin coverage of oral anticancer drugs within 90 days of enactment. These patients are facing life and death choices, I believe it is our responsibility to provide access to the most effective and appropriate drug therapies.

Congress recognizes the importance of expanding coverage to vital cancer treatments and in 1993 created a unique Medicare drug benefit for oral anti-cancer drugs. Unfortunately, coverage under this law only is provided if the drug is equivalent to drugs provided ``incident'' to a physician visit; for example, drugs that must be injected. At present, upwards of 95 percent of cancer drug therapy is covered by Medicare either in a physician office or as an oral form, which qualifies under the 1993 legislation. However, in the very near future as much as 25 percent of cancer drug therapies will be oral drugs not covered. By enacting this legislation into law, we can ensure these new outpatient cancer treatment therapies will be available to Medicare beneficiaries.

This is a developing trend. Today, there are about 40 oral anti- cancer drugs, but less than 10 are reimbursed by Medicare. In fact, one of the most common and effective drugs used in the treatment of breast cancer, tamoxifen, is among those drugs that currently are not reimbursed by Medicare.

As cancer therapy becomes more reliant on oral drugs, Medicare coverage policy must be updated to cover the new therapies. Otherwise the intent of the very limited 1993 policy will become meaningless and Medicare beneficiaries will increasingly lose access to the best cancer therapies.

Let me provide some very encouraging examples of oral anti-cancer drugs that illustrates the urgency of both this policy change and of enacting Medicare prescription drug legislation. Over the past two years, the FDA has approved a number of remarkable oral anticancer drugs that are producing outstanding results. Two such examples include Gleevec, which was approved in 2001 and IRESSA, which was approved on May 5.

Gleevec is used to treat one type of leukemia and may also be effective against a rare but lethal stomach cancer. It is the first, let me repeat, first, cancer drug to specifically address a molecular target, which not only is in the cancer, but actually is the cause of the cancer, according to the National Cancer Institute. More precisely, Gleevec eliminates a specific enzyme needed for the cancer to thrive. By contrast, most current cancer therapies act like a shotgun, killing both cancer and normal cells.

IRESSA, another revolutionary oral anticancer drug that the FDA recently approved, treats advanced non-small-cell lung cancer, NSCLC. Considering lung cancer is the leading cause of cancer deaths in the United States, estimated to account for approximately 157,000 deaths in 2003, and NSCLC is the

most common form of lung cancer, accounting for 80 percent of all lung cancer cases, it is imperative that Medicare beneficiaries have access to this new drug. For many who do not respond to chemotherapy treatments, IRESSA is the last line of defense.

However, both of these cancer treatments are expensive. For instance, while Gleevec is a revolutionary and highly effective treatment, it is not a cure. It simply arrests the cancer and returns most lab tests to normal, requiring many patients to take the drug for life. Considering the extraordinary costs of these treatments--a month's supply of Gleevec costs upwards of $2,400 and IRESSA, the last treatment option for many NSCLC patients, costs approximately $1,900 per month of treatment, with the average treatment lasting seven months--Medicare coverage is a necessity.

It is imperative that Medicare provide reliable access to these advanced medications to help beneficiaries with cancer. Biomedical research is providing new, more targeted, and less toxic methods of treatment through new oral anti-cancer drugs that patients can safely take in the comfort of their own homes, which will help improve outcomes and enhance patient quality of life.

We must act now to ensure all oral anti-cancer drugs are available to our seniors. The Access to Cancer Therapies Act will build on current Medicare policy by ensuring coverage of all anti-cancer drugs, whether oral or injectable, are available to Medicare beneficiaries. The Act will provide beneficiaries with access to innovative new therapies that are less toxic and more convenient, more clinically effective and more cost-effective than many currently covered treatment options. I urge my colleagues to support this bill.

Mr. President, I rise today to introduce a bill that would reduce the retirement age for members of the National Guard and Reserve from 60 to 55. This change would allow 93,000 reservists currently aged 55 to 59 to retire with full benefits and would restore parity between the retirement systems for Federal civilian employees and reservists.

In the interests of fairness, the United States must act quickly to restore parity between the retirement age for civilian Federal employees and their reserve counterparts. When the reserve retirement system was created in 1947, the retirement age for reservists was identical to the age for civilian employees. At age 60, reservists and government employees could hang up their uniforms and retire with full benefits. However, since 1947, the retirement age for civilian retirees has been lowered by 5 years, while the reserve retirement age has not changed.

The disparate treatment of Federal employees and reservists would have been serious enough had the nature of the work performed by the reserves not changed substantially over the past five decades. But America has never placed greater demands on its ready reserve than it does now. More than 200,000 reservists are serving their country in the war against terrorism at home, abroad, and in the conflict with Iraq. America's dependence on our ready reserve has never been more obvious, as reservists are now providing security at our Nation's airports and air patrols over our major cities. As Charles Cragin, the Deputy Assistant Secretary of Defense, recently noted, ``The nature and purpose of reserve service has changed since the end of the cold war. They are no longer weekend warriors. They represent almost 50 percent of the total force.''

With call-ups that last several months and take reservists far from home, serving the Nation as a reservist has taken on more of the trappings of active duty service than ever before. The recent conflict has only further underscored the demands placed on the National Guard and Reserve. Before the war on terrorism began, reservists were performing about 13 million man-days each year, more than a 10-fold increase over the one million man-days per year the reserves averaged just 10 years ago. These statistics, the latest numbers available, do not even reflect the thousands of reservists who have been deployed since September 11 nor do they take into account the number of reservists who have been deployed in the current military action against Iraq. There is little doubt there will be a dramatic increase in the number of man-days for 2002 and 2003. In my view, with additional responsibility should come additional benefits.

The Department of Defense typically has not supported initiatives like this. The Department has expressed concern over the proposal's cost, which is estimated to be approximately $20 billion over 10 years, although CBO figures are not yet available. However, I am concerned that the Department's position may be shortsighted.

At a time when there is a patriotic fervor and a renewed enthusiasm for national service, it is easy to forget that not long ago, the U.S. military was struggling to meet its recruitment and retention goals. In the aftermath of September 11, defense-wide recruitment and retention rates have improved. However, there is no guarantee that this trend will continue. Unless the overall package of incentives is enhanced, there is little reason to believe that we will be able to attract and retain highly-trained personnel.

Active duty military personnel have often looked to the reserves as a way of continuing to serve their country while being closer to family. With thousands of dollars invested in training active duty officers and enlisted soldiers, the United States benefits tremendously when personnel decide to continue with the reserves. But with reserve deployments increasing in frequency and duration--pulling reservists away from their families and civilian life for longer periods--the benefit of joining the reserves instead of active duty has been severely reduced. The more we depend on the reserves, the greater chance we have of losing highly trained former active duty servicemen and women. The added incentive of full retirement at 55 might provide an important inducement for some of them to stay on despite the surge in deployments.

Enacting this legislation will send the clear message that the United States values the increased sacrifice of our reservists during these trying times. The legislation has been endorsed by key members of the Military Coalition, including the Veterans of Foreign Wars, the Air Force Sergeants Association, the Air Force Association, the Retired Enlisted Association, the Fleet Reserve Association, the Naval Reserve Association, and the National

Guard Association. The bill would restore parity between the reserve retirement system and the civilian retirement system, acknowledge the increased workload of reserve service, and provide essential personnel with an inducement to join and stay in the reserves until retirement.

I hope my colleagues will join me in supporting this important legislation, and I ask unanimous consent that the text of the legislation be printed in the Record.