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Paul's Message

Dear ASN Members:
Several weeks ago, Dr. Mitch informed you of the National Institutes of Health (NIH)'s Roadmap for Medical Research. Recently, representatives from academic health centers, professional organizations, and health advocacy groups listened to NIH Director, Elias Zerhouni, MD, and other key NIH leaders provide specific updates on the NIH Roadmap Initiative. Dr. Zerhouni and others discussed requests for applications and initiatives currently in circulation, and future opportunities, and answered questions by attendees.
You will recall that in September 2003, Dr. Zerhouni introduced his NIH Roadmap. The NIH Roadmap is designed to transform the nation's medical research capabilities and speed the movement of research discoveries from the "bench to the bedside."
Developed with input from more than 300 nationally recognized leaders in academia, industry, government, and the public, the NIH Roadmap provides a framework of priorities that the NIH must address to optimize its research portfolio. The Roadmap lays out a vision for a more efficient and productive system of medical research and identifies the most compelling opportunities in three main areas: new pathways to discovery, research teams of the future, and re-engineering the clinical research enterprise.
ASN believes this is an extremely important topic and that serious attention must be given to the Roadmap Initiative and its implementation. The first question is: will the Roadmap Initiative be a positive or negative influence on the funding of renal research grants? To learn more about this initiative, please visit the NIH website.

Paul C. Smedberg
Director, Policy and Public Affairs
Fiscal Year (FY) 2005 Budget
President Bush submitted the details of his Fiscal Year (FY) 2005 budget to Congress on February 2. The $2.4 trillion spending plan calls for $818 billion in discretionary spending in FY 2005, an increase of $31 billion (3.9 percent). Defense spending is increased by 7.1 percent and homeland security grows by 9.7 percent. Other domestic discretionary spending is slated to increase by 0.5 percent to $386 billion.
Discretionary spending within the Department of Health and Human Services (HHS) is decreased by $1.1 billion (1.6 percent) to $68.2 billion. The Administration proposes to increase a few priority programs and freeze funding for the majority of discretionary health programs.
The President's budget includes $28.607 billion for NIH, an increase of $729 million (2.6 percent) and would fund 39,986 research project grants in FY 2005, an increase of 558 over the current year. NIH estimates this would provide for a success rate of 27 percent in FY 2005, equal to the projected FY 2004 success rate. However, the grant numbers are sustained by smaller than usual increases in the average cost.
Funding for the NIH Roadmap in FY 2005 is set at $237 million, an increase of $109 million over the current year. This funding is targeted at three broad initiatives:
* New Pathways to Discovery ($137 million): Focus on generating new knowledge and building a better "toolbox" for researchers in the 21st century, including new technologies, databases, and other resources.
* Multidisciplinary Research Teams of the Future ($39 million): Establish a series of awards for centers and training, as well as support for conferences aimed at building interdisciplinary research teams.
* Re-engineering the Clinical Research Enterprise ($61 million): Organize and support a new infrastructure that will facilitate the rapid translation of discoveries from the laboratory to the clinic; train a workforce of clinical investigators to test new therapeutic and preventive strategies; create clinical research networks with enhanced interoperability; and enhance the coordination of the important rules and regulations that ensure the safety and ethics of these studies.
Congress' Budget Update
The Senate Budget Committee will vote on its version of a FY 2005 Budget Resolution this week (March 3 and 4). The full Senate will debate the resolution during the week of March 8. The House Budget Committee Chairman, Rep. Jim Nussle (R-IA) and the House Republican leadership, will watch to see how much support the Senate bill, as drafted by Chairman Nickles (R-OK), receives, especially from Republicans, before unveiling and proceeding with the House version of the FY 2005 Budget Resolution.
In all cases, the Senate and House versions of their respective FY 2005 budget resolutions are likely to propose cutting discretionary spending, including spending for public health programs at the National Institutes of Health, Agency for Healthcare Research and Quality, Centers for Disease Control and Prevention, Health Resources and Services Administration, and the Food and Drug Administration within HHS, below the President's FY 2005 budget request.
The ASN recently joined other major health organizations in an effort to fight threatening budget shortfalls in critical health programs and to make funding for our nation's health programs a top priority for federal policymakers. The campaign, launched in January 2004, seeks to increase the Fiscal Year (FY) 2005 budget allocation for health programs, known as Function 550. Programs in Function 550 are directed by federal agencies dedicated to preventing disease, advancing medical knowledge, delivering key health care services, ensuring food safety, and training a diverse health and public health workforce.
The goal of the campaign is to develop a single, unified message that organizations can deliver to Capitol Hill. Working with the Coalition for Health Funding, it was determined that a 12 percent increase in Function 550 is necessary for FY 2005 to adequately fund critical health programs and improve the health, safety, and security of the nation. Since joining the campaign, ASN recently signed on to a letter to Congress and the President that calls for the 12 percent increase in Function 550.
In the era of tight federal budgets, ASN recognizes the need to convince policymakers to increase the allocation for Function 550 in the Federal Budget. Otherwise, FY 2005 budget allocations will leave congressional appropriators limited options to fund critical bio-medical research at the NIH that lead to scientific discoveries and improvements for the health of the nation. ASN is also concerned about funding for programs that seek to eliminate health disparities that disproportionately impact certain racial, ethnic, and rural populations which have higher rates of kidney disease and work force initiatives that recruit, retain, and train researchers, scientists and health professional and practitioners.
ASN Convenes ESRD Meeting
The ASN, in cooperation with the National Kidney Foundation (NKF), brought together individuals with expertise in assessing how to define and measure the quality of care provided to dialysis patients and the extent to which measures of care quality can be linked to improved patient outcomes. The working group, comprised of members from ASN's Dialysis Advisory Group, Policy & Public Affairs Committee, and Practicing Nephrologists Advisory Group, as well as dialysis providers, MedPAC, Centers for Medicare & Medicaid Services (CMS), and renal data/research experts, examined the existing data and reimbursement strategies for nephrologists. The group analyzed whether reimbursement strategies can rationally and scientifically be used to drive improvements in quality of delivered care and improvements in patient outcomes. An important component of this assessment is to perform a gap analysis, which may help guide future research and policy directions.
The goal of the meeting was to influence policy so that science can direct reimbursement policy to the greatest extent possible. The ASN will produce a white paper that will be a publishable symposia, and this will be circulated to CMS, MedPAC, and Capitol Hill. We believe the project emanating from two leading nephrology societies and nephrology research experts is the start of a forum that will examine several renal regulatory issues.
Ad-Hoc Group Health Research Summit
The ASN is participating on the planning sub-committee for the Ad-Hoc Group Medical Research (Ad-Hoc Group) Summer Research Forum. The Summer Forum will bring together leaders in the bio-medical research community to discuss justifications for future NIH funding requests, current scientific opportunities, how can scientific advances be best articulated to Congress and the public and how low funding levels such as the 2.3 percent increase in the President's FY 2005 proposed budget would be devastating to the research enterprise. ASN is very excited about the opportunity to serve on the sub-committee and the possibility of highlighting kidney disease research in the process.
NIH Conflict of Interest Blue Ribbon Panel
NIH's Director, Elias A. Zerhouni, MD, announced the full membership of the NIH Blue Ribbon Panel on Conflict of Interest Policies. Earlier this year, Dr. Zerhouni appointed Bruce Alberts, PhD, President of the National Academy of Sciences, and Norman R. Augustine, Chairman of the Executive Committee of the Lockheed Martin Corporation, to Co-Chair the Panel. The Panel's first meeting will be held March 1-2, 2004.
The Panel's charge is to review and make recommendations for improving the existing rules and procedures under which NIH currently operates regarding real and apparent financial conflict of interest of NIH staff and requirements and policies for the reporting of NIH staff's financial interests.
The Panel members are prominent leaders and experts in the fields of research administration and ethics management. The new Panel members are: Christine Cassel, MD, President, American Board of Internal Medicine and member of the ACD; Thomas H. Murray, PhD, President, The Hastings Center; Phillip Pizzo, MD, Dean, School of Medicine, Stanford University; The Honorable Stephen D. Potts, Chairman, ERC Fellows Program, Ethics Resource Center; Dorothy Robinson, Esq, Vice President and General Counsel, Yale University; Lawrence Sadwin, President, Lifestyle Security, LLC, and member of the NIH Council of Public Representatives; James Siedow, PhD, Vice Provost for Research and Professor of Biology, Duke University; and Reed V. Tuckson, MD, Senior Vice President, Consumer Health and Medical Care Advancement, UnitedHealth Group.
New CMS Administrator
President Bush nominated Mark B. McClellan, MD, to be the Administrator of the Centers for Medicare and Medicaid Services (CMS). Currently, Dr. McClellan serves as the Food & Drug Administration Commissioner. Dr. McClellan's first tasks will be implementation of the new Medicare law and continuing efforts to build a strong and responsive CMS.
Dr. McClellan previously served as a member of the White House Council of Economic Advisers and worked at Stanford University as an Associate Professor and Director of the Program on Health Outcomes Research. He was also an attending physician for internal medicine at Stanford Health Services.
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