(This is also posted on the "Andy Grove speaks out" thread where the comments by Greg are listed in their entirety from the PAN website, but since it is really a different subject, it deserves a separate listing... Oh and by the way 3 cheers for Andy who would be a wonderful spokesman for any cause, and we are fortunate to have him think and speak so clearly about our cause....pc)

I want to applaud my friend and fellow advocate for PD Greg Wasson for articulating in such eloquent, almost poetic terms, which is one of his special and unique talents, all the reasons why it is so important that patients take on new roles in the management of our own disease and that we be represented at the table at all levels of health care policy. I also want to applaud PAN for their bold stand to publicly sponsor Greg's words.

As a patient advocate who has worked many years on the issues that Greg speaks about, I would like to reinforce and embellish his statement in several areas based on the experience of the Parkinson Pipeline Project, which I founded to do what we as PWP can uniquely do to speed the delivery of more effective treatments to patients. Both Greg and Ann have worked with the Pipeliners to not only get to the table but to implement a comprehensive strategy to enhance the process of developing new therapies after we have taken our seats at the table.

The one man band joins an orchestra

I first became involved with FDA when I was recruited to the FDA Advisory Committee for Deep Brain Stimulation in March 2000, as a Patient Representative. After subsequent training, and interaction with staff, I began to be invited to advocacy meetings. Drawing on my contacts from over 25 years in Washington, I also began to meet key people in the review of PD treatments and in the planning and liaison offices established to buffer the communication responsibilities of reviewers with the public, so the reviewers can do their main tasks. As government officials FDA staff scouted and held public meetings and invited advocacy groups in from all of neurology to get viewpoints from a broad spectrum of the community.

With persistence and patience, after 3 years I was able to convince the FDA staff to add PD to their pilot program in oncology for Patient Consultants to FDA reviewers and 1.5 more years to implement the program and find ways to cope with restrictive Conflict of Interest procedures. The Pipeline Project has been a collaborator with the FDA staff to recruit, train and continually inform these advocates about important developments. This gives us leverage, in what I call a “teachable moment” for study staff and sponsors who want to get their protocols endorsed by review staff. For an appraisal of the entire comprehensive program designed to not only get to the table but also actually do something constructive once you are there see the Pipeline Project web site (www.pdpipeline.org)

The voice of the patient

Living in Washington, I go to many meetings on health policy and advocacy issues, including meetings sponsored by Government Agencies (particularly FDA, NIH, also CDC and AHRQ), Industry Associations (most often BIO, but also PhRMA), Professional Associations (such as the AAN), Coalitions of Patient Advocacy organizations (such as the Working Group on Evidence Based Medicine, the Personalized Medicine Coalition), and health policy forums (such as the Institute of Medicine). Often I am invited to speak from the patient perspective, but if I am not invited to speak, I will take the opportunity to make a statement on behalf of the patient perspective which is often different than the views of research institutions and even more different than the views of non-patient consumer organizations. I ask the simple question, why am I the only patient in the room, the only one who has participated in a clinical trial and the only one who lives with PD 24/7. Invariably several people come up to me afterward to say how important these statements are, because if no patients are in the room, patient interests are often overlooked.

After more than a half dozen years as a lonely messenger for incorporation of patient views into FDA and other healthcare decisions, in the past 1-2 years I have been coming into contact with greater numbers of leaders in the different forums who share this patient perspective. This increase in recognition of the value of patients’ input to decisions at all levels of health care research and decision making is rightly emphasized by Greg in words that echo the motto of the Pipeline Project on our home page (www.pdpipeline.org). I often use this statement when being interviewed, “The missing ingredient in development of new therapies is the voice of the patient.” The article “Deadly Caution” by award winning journalist Clifton Leaf in Fortune (2/2/2006) used this quote from me as the bottom line for a simple solution to the many problems of the FDA and the waning productivity of medical research.

PD Organizations

I cannot overestimate how important it is to have the backing and political support from our Parkinson's Organizations for the views of grass roots patients. Taking a pro-patient stance is not as simple as it would appear from the common sense view of the patient who listens to the rhetoric of industry and science. You would be surprised how often I have gotten my hand slapped for taking a patient oriented position with respect to what a clinical trial sponsor wants to do because of fear of reprisals, and even though I have a Ph.D. from a leading technical university, I have been excluded from meetings of vital interest to patients as well as researchers because I was a patient. As Greg points out in his presentation, medicine is traditionally doctor dominated. Patients are not perceived as competent and are expected to follow orders for treatment, and in experiments we are expected to measure up to animal models. PD organizations like many disease group s represent broad interests of researchers, universities, and funders from industry as well as patients interests so it is a milestone to have an organization as important as PAN to take up this goal.

Quoting from Greg's words provided on the PAN website

"The Parkinson’s Action Network (PAN) applauds this as an example of the FDA’s response to the general criticism that the missing voice at the healthcare policy table is the voice of the patient. I think it is vital that the patient voice be included not only in individual health care decisions, but at every level of decision making, including IRB’s, Advisory Committees to PhARMA and Biotech companies, and relevant government agencies. Patient participation in health care decisions still has a long way to go before it is an accepted fact and not just a platitude, but thankfully we are making a start. ……"

…… “Likewise, we must create tools by which the unique perspective, which only patients can give as to the experience of their illness and its treatment can be captured and used to better inform the policymaking process. Creating these tools will not be simple or easy, but create them we must if we are to make the once passive recipients of health care decisions made by others into effective and meaningful collaborators in developing healthcare policies and practices which will meet the new requirements of a new century.”