This very well stated Carey, eloquent and inspirational. And Tom’s statement puts the whole concept into a context with a spoonful of humanity with pinch of passion that I know I could have never understood before I had PD, but I am sure most do understand. It reminds me of a conversation I had with Tom a couple of years ago about so called "false hope" that PWP were being given by study doctors in the GDNF clinical trials. The power of hope is a prime basis for the uniqueness of the patient view

Very observent people recognize the patient perspective as a key asset at the table, necessary to solve this disease. Clifton Leaf, from Fortune Magazine, a cancer survivor himself comes to mind, when he quoted me with the bottom line on his thoughtful article on FDA, "Deadly Caution," saying the motto of the Pipeline Project, "The missing ingredient in the development of new therapies is the voice of the patient."


Legitimacy

As someone who has made great efforts to represent the interests of PWP in regulatory processes and with industry. I do not think it is possible to be the one voice for anything, because patients are people with different life situations and expectations. I present myself and the Pipeline project as an "authentic voice for patients." Through forums like this one and association with people like Paula, Peg, Carolyn, Greg, Ann, Linda, Ken, Sheryl, Jean, David E, as well as Tom and Carey, and many others who are active in leading opinion for those involved with PD advocacy, I try to stay tuned to the PD patient community opinion. I think we can safely say that we are authentic and well informed patients who take the Patient view only, whereas all the PD orgs. have other constituencies that influence them greatly. If other groups with PD presence want to challenge our legitimacy to speak for patients views, our response should be to work with them incorporate their views into our understanding of the patient perspectives, not squash them or blow them off. This way we maintain our legitimacy as a voice for the patient.

Real Influence
An example of the strength we have already gained is our relationship with the FDA staff in the Office of Special Health Initiatives (OSHI), who have the task of liaison with advocate groups. They rely on the PPP network to keep their hired PD patient advocates informed about PD science, clinical research, and the views of PWP in order to effectively represent patient interests. This provides some hope in itself, because it is the first nose looking under the tent that covers the black hole of FDA regulation of industry. My experience with more than a half dozen cases is that what goes on doesn’t always smell like roses, and that some light on the process will help control some of the problems by keeping a focus on patient concerns. This is at a critical time in the process of design of clinical trials when the patient voice can really make a difference, and already has in a number of instances. <We are fortunate to have 2 new FDA Consultants, PWP who are highly educated with scientific PhD's, former government regulators in their careers (one as an FDA reviewer), who have been active in the Pipeline Project and are working on behalf of PWP.>

Additional Goals
I would like to suggest other goals of this unified voice for patients to provide Leadership in setting the agenda for the PD community as a whole, which is appropriate give the success we have already demonstrated in the Pipeline Project and other patient motivated initiatives and advocacy efforts. We are not aiming at taking over roles being accomplished effectively by existing PD organizations, but we feel it is our mandate to identify gaps in the programs covered by the existing organizations and fill those gaps when the organizations fail to address our concerns.

The leadership of this new voice for patients is expected to establish by consensus rules

• a set of guidelines for PWP that evaluate and prioritize projects we as a group feel are worthwhile for patient volunteer effort,

• ethical standards and practical (such as reimbursement policies) criteria for consideration of PWP volunteers before they agree to work for an organization or make a financial contribution.

Also, if we do take initiative in program areas such as the PWP data base project which to my knowledge no one is doing adequately, that we expect that PD orgs respect this and support or at least not undermine our effectiveness.

These criteria will be helpful to increase trust and responsiveness of the PD organizations as well as industry and medical professionals to PWP needs.


Perry