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Winter 2004/2005 Volume 6, Issue 3:
Advocacy Update: Federal Support for Cancer Issues in Decline
By Greg Brozeit
The science of cancer research holds unprecedented promise. Unfortunately, the issues of federal funding dominating the political agenda—for cancer research and drugs and treatments through Medicare—are not addressing this opportunity.
The cancer landscape is changing. The science of cancer research holds unprecedented promise. Unfortunately, the issues of federal funding dominating the political agenda—for cancer research and drugs and treatments through Medicare—are not addressing this opportunity.

Current pressures on the federal budget will make it more difficult for cancer patients to reap the promised opportunities of research, new drugs, and better therapies and diagnostic procedures. It is not impossible to change the debate and the outcomes of political decisions. But first we must understand the challenges.

First, the good news—Congress and the Clinton and Bush administrations worked together to double funding of the National Institutes of Health (NIH) between 1998 and 2003. And while a portion of that doubling was diverted in 2003 toward bioterrorism research, funding for the National Cancer Institute (NCI) increased by approximately 85% over the 1998 level. The fact is, in terms of real dollars, we are spending far more on cancer research than we ever have.

One consequence of that funding is a deeper understanding of how genes and proteins behave in the life cycle of cancer cells. For the myeloma community, some of this knowledge has led to the discovery of proteasome inhibitors such as the drug Velcade®. Both the NIH and NCI directors had testified before Congress that in order to maintain the momentum of research activity spawned by the doubling, average funding increases of 8% were needed.

Unfortunately, the past two years have seen that funding momentum slow dramatically. Instead of the average 15% increases in NIH funding over the period of the doubling, the past two years have seen average increases of about 2%. As I have written previously, when factoring in inflation and previous obligations, those small increases actually translate into a reduction in research activity or, as NCI Director Andrew von Eschenbach has stated, “This means that every decision to fund something new requires a decision to not fund something else.”

The trend, sadly, is moving in the wrong direction. Consider the outcome of the fiscal year 2005 appropriation for NIH and NCI. Last year the House recommended increases of $727 million (2.6%) and $130 million (2.9%) for NIH and NCI, respectively. The Senate’s recommended increases were $1.1 billion (3.96%) and $154 million (3.25%). Usually, the final numbers that the conference committees produce fall somewhere between the House and Senate recommendations.

However, in an unprecedented step, when Congress approved the final bill after the November election, the final numbers were lower than the lowest numbers the House approved. When factoring in an across-the-board cut of 0.8% imposed on all programs in the appropriations bill, NIH got $28.26 billion, which included an increase of $463 million (1.67%)—$264 million less than the House number and $637 million less than the Senate. As for NCI, the final number was $4.82 billion, or an increase of $86 million (1.8%).

Exacerbating this negative trend, President Bush has recommended fiscal year 2006 budget increases of less than 0.8% for NIH and only 0.35% for NCI. It seems that in order to avoid the tag of becoming the first administration to ever propose negative numbers for medical research, some allies of the president strongly urged at least a symbolic increase in the budget rather than the 2% cut expected by most observers. Yet decreases cannot be avoided if the trends of the past two years hold and Congress imposes an across-the-board cut after passing the final appropriations bill. In other words, unless Congress takes a strong stand to oppose the administration, this year will likely produce a real cut in funding for the first time in the history of federal support for medical research.

Medicare Reform Targets Cancer for Cost Savings

Arguably, the big issue for cancer patients and advocates over the next two years will be the implementation of the Medicare Reform legislation enacted in late 2003. Cancer advocates, regardless of whether they receive Medicare benefits or not, should care about this issue because Medicare policies largely set the agenda for all insurers. Medicare issues ranging from the promised comprehensive prescription drug benefit scheduled to go into effect on January 1, 2006, oncology drug reimbursement policies enacted in January 2004 and January 2005, the oral drug demonstration project that will be in effect until December 31, 2005, and coverage for outpatient services and diagnostic procedures are all in a state of uncertain flux.

The common denominator for all the issues is cost. Just how much will the comprehensive prescription drug benefit be, and is there political will and courage to pay for what has been promised to the American people? When the bill was signed into law, Congress and the President agreed to fund the benefit with $400 billion over ten years. Later, that estimate was raised to $580 billion. On February 9, 2005, The Washington Post reported that the revised figure would be $1.2 trillion over ten years—three times the estimate when the law was signed in late 2003. However, some nonpartisan, academic studies have estimated the true costs could be as high as $2 trillion. Regardless of whether that estimate is too high or not, there is general agreement from all knowledgeable observers that the current cost estimates agreed upon by Congress and the administration are too low to pay for what the American people expect.

Ever since the bill was signed into law by President Bush, Medicare administrators have been figuring out how to close the gap between what will be set aside for the comprehensive prescription drug benefit and what it will actually cost. Last September, Medicare announced a 17% increase in annual premiums for 2005, the highest annual increase ever. But don’t expect it to be a one-time hike; it may be just the beginning of large annual increases.

More ominously for cancer patients and advocates, provisions of the legislation that went into effect in 2004 and 2005 are designed to take at least $500 million out of the oncology reimbursement system by January 1, 2006. This is being done by changes to the reimbursement payments made to oncologists for the drugs provided in outpatient settings such as, for example, bisphosphonate treatments for myeloma patients.

The issues adversely affecting oncology practices and patients include the closing of satellite oncology offices, patients being switched to cheaper drugs, reductions in oncology staff, and the refusal of oncology practices to take on new Medicare patients. However, there is little chance that these policies will change this year because most of the evidence of adverse effects on oncology practices is largely anecdotal.

The Patient Advocate Foundation has convened the Global Access Project to fund academic, nonpartisan studies to determine just how these new policies are impacting patient care and access to treatment. The IMF, other patient advocacy organizations, and other private and public groups are participating in this project. Some preliminary findings are expected to be made public in February 2005 with the hope that completed studies can be presented to Congress and the public within the next year. These studies will provide empirical evidence that will allow Congress to address any needed reforms when the prescription drug benefit is scheduled to go into effect.

Another attempt at cost savings at the expense of patient care was fought last year by the IMF and other organizations. As a part of the Medicare reform bill, Congress set aside $500 million or 50,000 patients, whichever goal was met first, to provide coverage for several oral and self-administered drugs until January 1, 2006.

The initial rules for the program prohibited the coverage of off-label prescription drugs. Off-label refers to the prescribing of a drug for a condition or disease for which it was not initially approved by the Food and Drug Administration (FDA). Today, approximately 70% of all drugs cancer patients receive are prescribed off-label. For myeloma patients, only Velcade® has been approved with a specific indication for myeloma by the FDA. In other words, unless a myeloma patient receives Velcade®, all of his or her drugs are prescribed off-label.

The IMF and other groups testified before Medicare officials for the inclusion of thalidomide in the oral drug demonstration program, arguing that it would be unjust to deny myeloma patients coverage for an oral drug that was used by as many as 85% of patients at some point in their treatment. Eventually thalidomide was covered. But the victory was more important than coverage for one drug. It set a precedent for Medicare to provide coverage for an off-label drug, a decision that will hopefully extend to all off-label cancer drugs when the prescription drug benefit goes into effect.

Another positive method of finding cost savings is through the improvement of technologies and therapies to eliminate or lessen the need for other drugs and treatments. Last year, Dr. Brian Durie spearheaded an effort to petition Medicare to cover PET scans for myeloma patients. Although a new cost, PET scans proactively determine the areas of active myeloma and can eliminate or lessen the need for invasive therapies and rehabilitation. This will ultimately reduce costs for Medicare and other insurers.

Patients and advocates must pay close attention to the implementation of Medicare reform in the coming year to ensure that access to the best and most appropriate drugs and procedures remains available to all patients that need them. And they must be vigilant that the upfront costs to implement Medicare reform are not unfairly shifted to cancer patients just because those costs are deemed too high by government bureaucrats.

Pay Attention, Advocacy Matters

In the Summer 2004 edition of Myeloma Today I posed the question as to whether we should be optimistic or pessimistic about the future of cancer research advocacy. The one thing we should not be is resigned.

There have been times in our recent history when foregone conclusions have been turned around by citizen action. Remember when congressional leaders decided they could eliminate funding for the Corporation for Public Broadcasting and the National Endowment for the Arts? Public outrage and advocacy turned that tide. Issues such as this should give us courage. After all, we aren’t talking about television. We’re talking about cancer, the cause of one quarter of all the annual deaths in our nation. But we have to pay attention to the news and advocate for our positions.

Consider the issue of cancer research funding. To put it simply, each advance in cancer research points to dozens of symbolic doors of new activity, each an opportunity for discovery that may lead to better drugs and therapies. While the doubling of NIH was underway, researchers were able to examine more and more of those doors which, in turn, led to the creation of new doors of discovery. Now that the funding stream is contracting rapidly, many of those doors may remain unopened much longer than they should. This must be changed.

Consider the isuue of Medicare reform. The issue should be quality of care. The debate on cost savings should not obscure the need to access the best drugs and treatments available. There is nothing crueler than knowing an effective therapy exists and then not having the means to get it. And if increased upfront costs lead to longer- term savings and quality of life, bureaucrats and policy makers must be educated to make the right decisions.

Politics and governing are caught between the pulls of looking forward to a better future while addressing the pressing issues of today. That tension—where we choose to expend our efforts to maintain equilibrium between the needs of today and a positive vision of the future—is constantly tested in different ways. It has never tested advocates of cancer, medical research, Medicare, and drug development and access more than today.

The fact is that the policies I discuss above will be implemented unless we, the advocates, remain vigilant, vocal, and full of purpose. The stakes are too high.


Your commitment is needed to help shape public policies to benefit the myeloma and cancer communities. For more information about how to become an effective advocate, please check regular updates in the IMF email newsletter, The Myeloma Minute (register at www.myeloma.org) and see the Advocacy section for updates and tips including:

• Timely updates on congressional action impacting cancer issues

• Sample letters to contact your members of Congress and the administration

• Assistance to set up meetings with your members of Congress at home and Washington, DC

• Suggestions to contact your local media to highlight cancer issues

Feel free to contact IMF Director of Public Advocacy Greg Brozeit for more information at 330-865-0046 or greg.brozeit@sbcglobal.net.

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