Advocate Summary

Issue:  INS Funding for Cystic Fibrosis
Advocate:  Cystic Fibrosis Foundation – Suzanne R. Pattee
Date of Interview: 7/11/02

Basic Background
The main issue we work on is increasing funding for NIH. There has been an effort in the last five years and we are part of a coalition on it, and that is to double the budget of the NIH by 2003. So we are lobbying for the final year. [So is that the most recent issue you’ve been active on?]  Well it’s an ongoing issue but that is the one we’ve been working on lately on in the past couple of weeks, we prepared a letter writing campaign and asked our grassroots to send in letters to support increases in NIH funding and to support CF funding in the NIH, for CF funding. 

Our goal is to raise the budget of NIH to the target of 27. 3 billion for this year and that is probably going to happen, everybody on the Hill seems to agree. But now the question is how to best use this money and research. So we are trying to encourage them then to spend some of those dollars directly on CF research. There is funding already on CF research, the Foundation doesn’t actually receive any federal grant money or state money, we are primarily driven by special gifts and special events like dances and dinners and golfs and stuff like that. We actually asked the government to increase their research so that the researchers we work with can help to collaborate and network and so that they can apply for research grants. 

You just get a dollar figure in the appropriations language. You could get an authorizing bill that would authorize this type of funding, and that would be one step, but that doesn’t guarantee that you’ll actually ever get the funding and there wouldn’t be any regulations again, it would just be the dollars. And with the NIH, you have Congress saying here we want you to do this and then they would be more inclined to do it and they could do it anyway they wanted, they could spend the money anywhere in the country, there’s no restrictions on the grants, they’re not restricted geographically. So we would try to get report language in the report at the end of the year, and that would have numbers, and this is what we think you are doing well and NIH should do this or that. 

Prior Activity on the Issue 
[They’ve been working on the general funding for five years but the issue now is really funding specifically for CF research]

In 1998 we developed a clinical trials network and we call it the Therapeutics Development Network. And this network has pulled together right now eight centers and they have a coordinating center in Seattle – University of Washington, and the eight centers are at different academic universities, John Hopkins in Maryland and Boston Children’s and Harvard, Stanford, University of North Carolina, Children’s in Denver, UNC Chapel Hill, Case Western Reserve University, Children’s Hospital in Cincinnati and those kind of organizations that do a lot of research but now also do clinical trials research, and have been spearheading a number of clinical trials on CF research, potential drugs that could be useful for our disease. So our goal here, this network is helpful in attracting other people interested in developing drugs for CF, like drug companies or biotech companies. Some of the smaller companies, they can come to us and bring an idea for something, and we can help them design the clinical trial and help them get access to the expertise and the patients as well as the safety of the patients, because we have a safety monitoring board to make sure the trials are run as safely as possible. So we have this whole network for groups to take advantage of for their research ideas for cystic fibrosis. And right now we are getting some funding from the NIH for the coordinating center and for some of the academic centers. Most of them are linked with the GCRC, the General Clinical Research Center through the National Center for Research Resources NCRR. The NCRR is the part of the NIH that we have been working most closely with. 

Advocacy Activities Undertaken
The NCRR is the part of the NIH that we have been working most closely with. So we are already getting some funding and we are asking the Congress encourage NIH to give us more funding because we think that this is a model network that is helpful for our disease, we are trying to speed up the pace of research and evaluation of the disease as well as reduce the cost hopefully, because if you can reduce the cost because if you can do it faster and do it at lest cost then hopefully our patients can get it more quickly. So we’ve been asking people on Capitol Hill as well as meeting with NIH to try to make sure that we can secure additional funding for this effort. So that’s been going pretty well but it’s hard. Everyone seems to recognize that it is a very valuable network, and it has a lot of potential and that it can be used as a model but they look at it at our success - that shows that we’ve been able to fund it so far, so therefore why do they need help to fund it. Well we can’t keep going, and we want to expand it because we have a lot of new opportunities in research and we want to expand it to twenty centers within the next year or so, so we can do more research more quickly.

On funding for the NIH generally we worked with the Ad Hoc Group for Medical Research Funding, they are staffed by a group called the Association of American Medical Colleges, it is a broad coalition of patient groups as well as colleges and universities and they mainly focus on funding they don’t get involved in many of the issues because there’s not always consensus on them of course. This work on the network is more our own initiative and we do work with some of the companies because they are interested in CF research and want to work with us so that we can have a good new treatment for our patients. That’s been more of our specific goal. 

We weren’t granted a slot this year on the appropriations committee to testify. We brought folks in March of last year in 2001 to testify on this issue, NIH more broadly, but this specific CF funding as well. 

Future Advocacy Activities Planned
We’re thinking about doing some more general awareness activities in the fall, but we’ve been hesitant to support a general effort to create awareness because when you’re talking to congress and you’re asking for their help you want to have a good reason to do that. 

Key Congressional Contact(s)/Champions
It’s always hard, I mean what is the definition of a champion, many of them will help us but I don’t know if you could call them a champion. Right now we are working closely with Senator Ben Nighthorse Campbell (R-CO) he has introduced a resolution for a week in October as Cystic Fibrosis Awareness week. And so we’ve been pleased with that and trying to use that to educate other folks in the Senate about the disease. And the potential for advances through research and he has a number of co-sponsors.

[Is their anyone you’ve been specifically talking to about increasing CF funding?] 
We talked with a number of folks, specifically we’ve gone to the states where they have a therapeutic development center, such as Colorado and Seattle and Texas has a strong center and we had a meeting with the Senator from Texas – Bailey Hutchison (R). We’ve also met with Steny Hoyer (D-MD) he’s also been very supportive, we honored him last year at our annual Congressional dinner, and he’s always been very helpful, but he’s been helpful in the appropriations process because he’s on the committee. And Representative Nita Lowey (D) from New York as well.  

Targets of Direct Lobbying
None mentioned.

Targets of Grassroots Lobbying
None mentioned specifically. 

Coalition Partners: Names/Participants
[None on this specific issue]
On funding for the NIH generally we worked with the Ad Hoc Group for Medical Research Funding, they are staffed by a group called the Association of American Medical Colleges, it is a broad coalition of patient groups as well as colleges and universities and they mainly focus on funding they don’t get involved in many of the issues because there’s not always consensus on them of course. This work on the network is more our own initiative and we do work with some of the companies because they are interested in CF research and want to work with us so that we can have a good new treatment for our patients. That’s been more of our specific goal. 

Other Participants in the Issue Debate
[The pharmaceutical corporations she discusses do not appear to have been involved in any government advocacy.]

Some of the new drugs that have come out are, one from Genentech, they developed a drug called Pulmison (sp?) that came out and was improved in 1993 and another company called Chiron has made a drug called TOBI and that was actually done by a company called pathogenesis and Pathogenesis was bought by Chiron. Much of the early work to show the value of TOBI was actually funding by the Foundation and then we had to seek a corporate partner that could develop and manufacture and wanted to go ahead and take it to market. So we’ve always been very proactive in getting the researchers involved. And there are a number of other companies for example Genzyme Corporation is a strong research partner we provide them with direct funding. We do provide basically funding whether they are academic or industry whoever they are. We’ve also been developing and getting grants to get people involved in the latest medical technologies and bringing those technologies to cystic fibrosis. So we’ve had an initiative to bring screening to CF.   

We’ve been working with Judy Vitakitus at the NCRR at NIH. And we’ve met with Allen Spigel and Allen is head of the National Institute for Diabetes, and Digestive Diseases and CF affects the lungs and the digestion so it makes sense there. And we were trying to meet with some folks at the Heart, Lung and Blood Institute as well as Child Health, so we try to look around, and actually we work closely with the Human Genome Research Institute, Francis Collins there. Francis Collins was one of the co-discoverers of the CF gene so he’s always been a strong advocate for us.  

Ubiquitous Argument(s) and Evidence
Our main arguments would just be the value in investing in research and that’s not a hard sell, most people are supportive of research., and specifically, our mission, the fact that we have been successful so far. There are a few new drugs that came out in the ‘90s that didn’t go through the process but they were used to model this process, they predated it so we show that as an example of success and right now there have been drugs that have come out and they’ve gone through the process, a couple of phases of research trials, so that’s helpful to show, that they’ve been reviewed relatively quickly and the main thing is the safety of the clinical trials. We have a Safety Monitoring Board and that has cystic fibrosis care givers on it who know the process and they can help identify if a patient has what you might consider a adverse event, maybe they developed a cough, they can help discern if it is a cough from the disease or a cough from the administration of a new therapy. So that information is really valuable to ensure the safety of the trials. 

Secondary Argument(s) and Evidence
None mentioned. 

Targeted Arguments, Targets, and Evidence
None mentioned. 

Nature of the Opposition

[Impediments]
The concern of course is that congress does not provide earmarks, they are hesitant to tell NIH how to spend their money. But I think they might start making more demands, and they have started to make more demands they’ve increased the budget and they want to make sure their money is being spent wisely. So we want to show them that this is a really wise use of the money, and we really are aggressive. For our patients the life expectancy is only 32 and that is an improvement of the last 20 years but it’s not long enough obviously. So we just try and push as hard as we can in every direction. But that is the main concern that their not crazy about earmarks but they have been supportive in stating that the NIH should get mor involved in CF research and support clinical trials. It’s not a hard sell but it is to make it happen. Everyone says well we don’t have the money for it - even though they have this huge increase, - well we have this idea and that idea. So we are trying to have a collaborative relationship with all the parties to make it work. And you know once you earmark everybody comes in wanting an earmark.. And since they don’t earmark it’s cut back on competition between disease groups but also because of the efforts to double the budget, everyone realized that they had to work together on that. But of course each group is going forward with their own concerns. And since we are such a small disease group we have trouble getting the attention of members of congress. For example – diabetes – there are so many people in this country that have diabetes and congressmen that are effected personally that it is easier for them to recognize the importance of getting involved, I think they have a Congressional Diabetes Caucus, with probably just about every member involved, so there’s just no way we could garner that attention. Unfortunately/fortunately - that there aren’t that many people with the disease. 

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
House and Senate Appropriations Committees

Action Pending or Taken by Relevant Decision Makers
There is no specific action pending. 

Policy Objective(s) and Support for/Opposition to the Status Quo
Working to increase NIH funding for CF research 

Advocate’s Experience: Tenure in Current Job/Previous Experience
I got involved because I have the disease, I actually started working here in 1985 as an intern right out of college and got interested in the policy while I was here and then went to law school at night and then went to work for the biotech industry for a bit, learned a more about how that works and the legislative work they do. 

Reliance on Research: In-House/External (Code for Organizational Advocates Only)
This year we have an outside firm that helps with our legislative work and our lobbying work and it’s a law firm, we also have survey work done, we have that in funding issues as well with the FDA and the EPA. Last year we had a PR firm that we retained but we didn’t retain them this year. We hired a director of media relations internally and that’s been really helpful. 

We developed a general fact sheet, about two pages and we have a background brochure about our organization it’s not too scientific we try to keep it understandable. We have the general statistics about the disease and that there are 30 thousand patients, and we have a break down of the number of patients by state, but again it’s a small population, so you wonder whether it’s helping or hurting your case. Lately we’ve tried to focus on the amount of research going on in different states clinical and research sites that are involved, and that seems to be effective.  

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

Units in Organization Involved in Public Affairs/Policy (Code for Organizational Advocates Only)
As far as lobbying goes I would be the primary lobbyist and the only lobbyist really but we have the senior management when needed on the Hill, our president and CEO often go and our executive vice president of medical affairs, who’s an MD and has the disease as well he is also very involved, they’ve both been going with me to the NIH but not to the Hill. And we do have a communications department that handles all of our communications issues and now media relations as well and they do some of the medical writing and grant writing and the development of resources for the patients. For our entire office we have 550 people across the country, we have 80 offices around the country and that can be an office of 10 or an office of 1 it depends on the area, and here since this is the national headquarters we have all of the accounting here, and we do oversight of the fundraising, we don’t have our local offices do any lobbying, not even state, they do it very, very rarely. And then we have a pharmacy that we do a mail order pharmacy that we set up in 1989 to buy in bulk medications to help our patients since it’s such a small population, so we have staff here that handle the requests. As far as legislative affairs I’m the only one really and then the outside firm. So we have about 100 here. 

Advocate’s Outstanding Skills/Assets (Code for Organizational Advocates Only)
None mentioned.

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

Membership Size (Code for Organizational Advocates Only)
We are a small disease group, we only have 30,000 patients in this country

Organizational Age (Code for Organizational Advocates Only)

Miscellaneous
We’ve admired a lot of the work and research the Juvenile Diabetes Research Foundation has been doing I don’t know if they have a network but they do model some of our things like the research grants. We do work closely with NIH and if they give a positive review to a research grant but are unable to fund it then we have a policy that we will look at it and try to fund it as well. 

[She noted  that they’ve also been working with the EPA on another issue concerning a specific bacteria that effects CF patients – more information on this in the folder]