Advocate Summary

Issue:  INS Funding for Cystic Fibrosis
Advocate:  INS – National Center for Research Resources - Dr. Judy Vaitukaitis 
Date of Interview: 7/31/02

[The tape recorder destroyed this tape, therefore this is paraphrased]

Basic Background
Here at NCRR we are concerned with infrastructure not the disease of the week. We work in connecting the steps in various areas of research and work to develop those technologies. Our budget is at about a billion a year, we are the 7th or 8th largest budget out of all 27 institutes and centers, some here were getting worried – is it okay that our budget is larger than some of the institutes’. We have grown three and a half fold in the last ten years and we are very aware of that. We deal with a lot of lobbyists. We aren’t allowed to lobby, we are supposed to be neutral so we have to influence Congress through outside groups, you’ve heard of iron triangles? So we work with a lot of groups, AMC, AAU; we need to triangulate to find out what the priorities are, I guess we focus on groups of diseases of the week. 

Prior Activity on the Issue 
I previously was director of the GCRCs (General Clinical Research Centers) which are within NCRR. There are about 80 GCRC they have to be general in that the labs and the technology have to be applicable in at least three areas, they can’t be labs concentration on only one disease. I had a idea that it would be good to network these research centers so that they could share their data and that it would all go to a central processing point. Before when a national clinical trial took place all this infrastructure would be developed and data collected and then when the trial was done it would be dismantled. I thought that was a waste and wanted to set it up so that the infrastructure could remain in place. I went to the Heart Institute and the DDK but the didn’t want to do it. 

Advocacy Activities Undertaken
So Bob Bell of the Cystic Fibrosis Foundation came and asked me if NCRR would help them fund their clinical trials network, which is an example of a network and a coordinating center for national clinical trials. Since they already had a lot of infrastructure in place we decided to go ahead, the centers had to be co-located with a GCRC, to have a lot of clinical research going on. 
The Cystic Fibrosis Foundation is a very well run foundation, they are very sensitive to patient concerns. Now they want to expand to phase 3 clinical trials, right now they are only doing first and second phase trials, and see if the program could be accelerated. These networks, since the infrastructure is already in place, allow the treatment to go directly to trial, small biotech companies are even approaching the network asking to be included because it is so quick. They also want to expand to include centers outside the GCRCs, we can help them with some of the costs but not all of them, and especially not the reoccurring costs such as annual salaries. Only if they are more general could we fund them. We are working to include eight minority medical schools because the minority medical schools often don’t get the funding and they are at other disadvantages and there are health disparities, minorities don’t always react the same way to treatments. People think everyone reacts the same way and that’s not the case, and it may not even be from genetic differences but different cultural customs such a food that would result in individuals reacting differently to treatments. So by bringing the minority schools in we are dealing with two issues at once which is good. And we are also working on starting outpatient opportunities at the minority medical schools.  

If Congress requests something specific in the report language, we treat report language like bill language and if we receive letters from members we would try to do that. 

Future Advocacy Activities Planned
None mentioned.

Key Congressional Contact(s)/Champions
None mentioned.

Targets of Direct Lobbying
Not applicable. 

Targets of Grassroots Lobbying
Not applicable. 

Coalition Partners: Names/Participants
Cystic Fibrosis Foundation

Other Participants in the Issue Debate
I met with John Marburger the president’s science adviser, and he was very surprised about what we are doing, he didn’t know we did things like this, I met with him to just give him a sense of what NIH does when he first was appointed. 

[No others mentioned specifically on this issue she noted they often work closely with NSF and Department of Energy generally but they don’t seem to have any part in funding the network. Early on since there budget was so small they worked closely with NSF and “piggy backed on NSF funds”]

Ubiquitous Argument(s) and Evidence
We have to provide Congressional justification for our budget, why we are spending what we are spending where. This network in included in the Congressional Justification you can’t get much more specific than that.  But this is an effective network, once the infrastructure is in place it becomes much more efficient, streamlined and is therefore more effective. It is mutual interests working together. The CF Network as well as the Biomedical Informatics Research, which focuses on neuroscience, both provide a model for future research networks. And there is so much data these days that coordinating centers and the computational grid becomes essential, an investigator can no longer lay everything out on the table and make sense of it, they have to go through some massive data processing. 

[the Congressional Justification document is in the folder – the CF section is noted]

Secondary Argument(s) and Evidence
None mentioned.

Targeted Arguments, Targets, and Evidence
None mentioned.

Nature of the Opposition
There is no opposition, just that some other rare diseases are going to begin asking for funding as well, like Adrenal Lucre Dystrophy. 
 
Ubiquitous Argument(s) and Evidence Articulated by the Opposition 
Not applicable.
Secondary Argument(s) and Evidence Articulated by the Opposition
Not applicable. 

Targeted Argument(s) and Evidence Articulated by the Opposition (and Targets)
Not applicable. 

Described as a Partisan Issue
No.

Venue(s) of Activity
NIH – NCRR

Action Pending or Taken by Relevant Decision Makers
The ’03 HHS appropriations bill will be likely voted on in September after the recess, it remains to be seen if Congress will put report language in regarding CF. 

Policy Objective(s) and Support for/Opposition to the Status Quo
Supports increased funding for the CF networks and other future networks. 

Advocate’s Experience: Tenure in Current Job/Previous Experience
[Dr. Vaitukaitis’s biography from the NCRR webpage is in the folder as well]

Reliance on Research: In-House/External (Code for Organizational Advocates Only)

Number of Individuals Involved in Advocacy (Code for Organizational Advocates Only)

Units in Organization Involved in Public Affairs/Policy (Code for Organizational Advocates Only)

Advocate’s Outstanding Skills/Assets (Code for Organizational Advocates Only)

Type of Membership: None, Institutions, Individuals, Both (Code for Organizational Advocates Only)

Membership Size (Code for Organizational Advocates Only)

Organizational Age (Code for Organizational Advocates Only)

Miscellaneous