From The Desk of Kim McCleary

August 1, 2005

The National Institutes of Health (NIH) is the world’s largest biomedical institution. With an annual budget of $28 billion divided among 27 Institutes, Centers and offices, the NIH conducts and sponsors basic and clinical research, supports training grants and educational activities and fosters the translation of science to better diagnostic tests and techniques and treatments. The research it funds is important not only in terms of what that research contributes to understanding of disease and the body’s complex biology; it’s also symbolic of the government’s research priorities, sending a signal to the international research community about where opportunity exists – and where it doesn’t.

NIH funding for CFIDS research totals $78 million from 1990-2004. In recent years, the annual investment has dropped from an all-time annual high of $7.4 million in 1995 to the current level of $6 million – placing CFIDS at the very bottom of the NIH funding chart. Last fall, the Association released a 45-page analysis of NIH funding, documenting that over the past five years, $5.2 million reported as spent on CFIDS actually related to studies that have nothing to do with the illness. Since then, we’ve asked Congress to be more forceful in its requests for NIH to expand CFIDS research. (Read news of recent progress.) The annual appropriations (funding) process is one opportunity for Congress to assert this direction. Another exists through a more infrequent legislative activity – NIH reauthorization.

Every few years, Congress renews the NIH’s authority for certain programs and activities. This legislation, referred to as reauthorization, last passed Congress in 1993 and officially expired in 1996. That law included three CFIDS-specific provisions. It created the CFS Cooperative Research Centers, mandated inclusion of CFS advocates on NIH advisory committees, and created a special study section to review CFS research proposals. Only the study section still remains, and it’s often identified by researchers as more of a barrier than a benefit.

Most members of Congress agree that NIH reauthorization is long past due and lawmakers have committed to passing new authorizing legislation before this session adjourns in October of 2006. Congressional priorities for NIH reform include streamlining the budget, granting the NIH director more funding authority and improving oversight and reporting systems. Past attempts at reauthorization have bogged down over hot-button issues like stem cell research and studies of sexually transmitted diseases. This year, ethics concerns about outside consulting arrangements for NIH investigators and human subjects protections are likely to further polarize debate.

Representative Joe Barton, chairman of the House Energy and Commerce Committee, has drafted legislation proposing a sweeping reorganization of NIH. In the first hearing on the bill, held July 19, 2005, NIH Director Dr. Elias Zerhouni expressed enthusiasm for the proposal, but he stopped short of giving it his full endorsement. “I see great wisdom in what the committee is proposing,” he said, suggesting that the details still need to be worked through. The text of the bill has not yet been released to the public, but it is reported to give the NIH director tremendous latitude in restructuring the agency and determining funding priorities. It may also dramatically change the way the public and advocacy organizations can impact research funding issues. It’s unclear whether the Senate Health, Education, Labor and Pensions Committee will start with Rep. Barton’s proposed bill or write its own version.

The Association has already begun engaging authorizers in Congress about the woefully inadequate effort NIH has made to cultivate a serious research effort for CFIDS, especially between 1999 and 2003 when Congress doubled the agency’s budget. We will continue to highlight institutional barriers that hamper research on multisystem illnesses and will call for greater transparency of the agency’s funding practices and priorities.

Changes Ahead for NIH and Research Advocates One of the reform measures we will champion is the creation of an office to direct trans-NIH initiatives. Presently, NIH is organized by organs and body systems (e.g., National Eye Institute, the National Heart, Lung and Blood Institute, etc.). Working groups link administrators and researchers from different institutes who handle a particular disease or families of disease. However, these groups are often voluntary in nature, lacking formal infrastructure, administrative support and funding. They suffer or dissolve when staff-participants take new positions or leave NIH and the outcomes they produce are uncertain and largely unmonitored. For multisystem conditions like CFIDS that don’t fit neatly into body-system silos, the participation of scientists and program staff representing diverse disciplines is crucial. We’ll join with others who advocate strategies that foster productive partnerships to transcend this  antiquated structure.

These last two issues have been raised by a multitude of groups, including the NIH’s own Council of Public Representatives that reports directly to NIH Director Zerhouni. We’ll also analyze the strengths and weaknesses of reauthorization proposals as they’re made available.

Although the $4 million Request for Applications issued by NIH  on July 14, 2005 is a notable step forward, we cannot neglect the opportunity to engage in NIH reform. When Congress returns from recess on September 6, the CFIDS Association will represent the interests of the CFIDS community – patients and researchers alike – to ensure that our needs and concerns are addressed in future hearings and drafts of legislation. As more information becomes available, we’ll alert advocates to timely opportunities to contact members of Congress, NIH officials and the press through our Grassroots Action Center and CFIDSLink. We hope you will help raise the visibility of CFIDS by responding to these calls to action. The future of CFIDS research may depend upon your participation!

With appreciation,
K. Kimberly McCleary