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Strengthening the Udall Centers
In 1987, a young lawyer from California named Joan Samuelson, who had just been diagnosed with Parkinson's, initiated a national campaign to lift the federal ban on using human fetal cells in research for Parkinson's disease at a time when PD and the people who live with it were virtually invisible in Washington. Just four years later, the organization Ms. Samuelson founded, the Parkinson's Action Network (PAN), brought hundreds of Parkinson's advocates to Washington to demand a focused federal research effort to end Parkinson's. The fruits of their efforts were evident in November of 1997, when Congress passed, and President Clinton signed, the Morris K. Udall Parkinson's Disease Research Act, which authorized up to $100 million to support Parkinson's disease research.
To many in the Parkinson's community, the jewels in this legislative crown were the Morris K. Udall Parkinson's Disease Research Centers of Excellence, a group of movement disorders research centers at major research universities. The purpose of the Udall centers, which were allocated a total of $72.6 million over five years, was to stimulate scientific research to improve the diagnosis of and treatment for PD and to advance an understanding of its fundamental causes.
To date, eight of the original 11 centers (including Columbia University, the recipient of PDF's major research center grant) have been re-funded for a second five-year term. One of the centers has dropped out of the program, and the remaining two have been put on temporary funding while government research administrators ponder their future. In the meantime, two centers have been added, yielding a total of 12 currently-funded centers.
At this time, various interested parties, from government administrators to patient advocates, are asking some leading questions: Have these Udall Centers provided new hope for the Parkinson's community? And what should we be doing to make sure that they perform even better in the future?
What Udall Centers have accomplished
There is broad agreement that much has been accomplished in Parkinson's research at the Udall Centers. Among the specific outcomes of this work:
- At the Mayo Clinic Udall Center, researchers are studying the alpha-synuclein gene - the first gene mutation to be linked to Parkinson's - to see how variations in the gene may affect people's susceptibility to Parkinson's;
- Scientists at the Columbia University Udall Center have found that when "Bax," a molecule known to be linked to cell death, is removed from laboratory mice, their vulnerability to a Parkinson's-inducing toxin is greatly reduced;
- Researchers at the University of Virginia Udall Center have found evidence strongly suggesting that defects in mitochondria (the "powerhouses" of a cell) are key to the development of PD.
No one doubts that the funding provided by the Udall Act has produced great accomplishments at these and other academic medical centers. But just how efficient has the investment been? How successfully have these terrific research centers worked together, and how well have they achieved the proper balance - called for explicitly by the language of the Udall Act - between basic research (i.e., understanding a disease's cause and development) and translational and clinical research (i.e., applying that understanding to the needs of today's patients)?
The views of the Parkinson's community
Earlier this year, the Parkinson's community, led by PAN and its executive director, Amy Comstock, began to take stock of the situation. In a June 3 "white Paper" setting forth considerations for amendments to the original Udall Act, PAN credited the program overall for significant accomplishments, but noted some concerns that, in its view, merit serious procedural consideration from Congress and the NIH.
One of these continuing concerns is the degree of coordination among the centers. The authors of the assessment note with approval a recent initiative to create a Parkinson's Disease Data and Organizing Center (PD-DOC), a unit established to help coordinate patient data from the various centers. However, that data center alone is not enough; what is needed is a coordinating center that will "serve to share all aspects of research at the Udall Centers."
A second and perhaps more serious issue concerns the review process that NINDS uses to select the Udall award recipients, which receive, on average, $8 million over five years. Since the outset of the program in 1998, critics have charged that Udall center proposals are reviewed and scored in the same way as are the routine project grants that make up more than three-fourths of NIH funding - rather than being judged on a separate track, the way the Alzheimer's Centers of Excellence are handled. This means that candidates who take pains to observe the unique guidelines of the Udall Act - for example, the requirement for collaboration, and the setting up of advisory committees - are often not given credit in the review process and may actually be penalized.
A third point of PAN's assessment is that NINDS has paid insufficient attention to the requirement of the Udall Act that "each center…shall…conduct basic and clinical research." The result is that fewer than half of the Udall Centers have a clinical research component in their grant. For people living with Parkinson's, this means that insufficient attention is being paid to capitalizing on the findings in the basic sciences to develop and test new potential treatments - in effect, slowing down the development of new treatments that the Udall Act was designed to support.
The NINDS review
Meanwhile, NINDS was readying its own evaluation process of the Udall Centers. In early September, 2005, more than a year after initiating a planning process for the evaluation, NINDS Director Dr. Story Landis announced that the agency had contracted with Booz Allen Hamilton (BAH), a prominent Washington-based consulting firm, to conduct an evaluation of the program. The review is designed to focus on the extent to which the Udall Centers have achieved their short and long-term goals. The study is primarily about "outcomes" - that is, how effectively did the Centers achieve their research goals? Its secondary function will be about "process" - meaning, for example, how well have the Centers worked together and with NINDS?
On October 17, NINDS hosted a conference call with the patient-voluntary organizations to explain the forthcoming BAH study. Following the meeting, the patient-voluntary participants sent Dr. Landis a letter, complimenting the review team for "the thoroughness of their approach" and offering two recommendations to improve the proposed plan. One is to strengthen the intent to "more affirmatively compare the RFA (an NIH document that gives candidates for Udall Center grants the specifications of what it is that they are expected to do) to the [Udall Act] statute, to ensure that the RFA incorporated all of the requirements for the program that are in the statute… of particular interest is the statutory emphasis placed on clinical research…and on advancing the prevention, diagnosis and treatment of the disease."
The other major recommendation of the letter was to strengthen representation of patient-voluntary organizations on the Expert Advisory Panel that NINDS plans to convene to monitor the evaluation process. The letter calls for the panel to include two representatives of the community, compared with the one member that has been proposed, to ensure that patients' perspectives are incorporated into the process.
The state of play
There is broad consensus that federal research centers focused specifically on Parkinson's are essential to understand the disease and find its cure. Legislation now pending in Congress to amend the Udall Act of 1997 (HR 3550, introduced by Rep. Lane Evans) calls for continuation of the Udall Centers. In a letter from the major national PD groups to Rep. Evans endorsing this legislation dated October 14, it is noted that the bill "will require the NIH to focus more of its Parkinson's dollars on translational research and therapies, [to] recognize the unique aspects of the Udall Centers, and [to] give us a stronger understanding of who is impacted by this devastating disease."
For most Parkinson's advocates, the task ahead seems clear: to take a good program, to celebrate its undoubted achievements and to take steps to ensure that it becomes even better in the future.
Robin Elliott is Executive Director of PDF. He also serves on the PAN Board of Directors.