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I want to clarify my recent post to the List and update information on DBS approval by FDA. Sid Levin wrote: Perry, Your idea of consumers on the approval committee, similar to aids involvement is GREAT! I was selected by the FDA to be (non voting) patient representative for the DBS panel last March. By law FDA already has patient representatives for AIDS and certain cancers, but this was the first time they have had a PD patient rep. I have been offered training by FDA to further this role. I was told by the FDA staff for patient representatives that AIDS activists have successfully lobbied Drug companies for patient participation in the design of clinical trials for FDA approval. I have some high level contacts at Amgen which has the rights to GDNF and another promising nerve growth factor (a neuroimmunophillin, NIL-A, previously GPI 1046) that is now in phase 2 clinical trials. I would like to find a way to speed up the process of development of new therapies without sacrificing safety and efficacy. There has been recent discussion on the list by John Cottingham and others about the great value of DBS treatment for PD. I have not noticed any mention of the fact that use of the device for the major symptoms of PD has NOT yet been granted full FDA approval. About 2 weeks ago, I spoke to the FDA executive secretary for the DBS panel that had unanimously recommended DBS for approval in treating 4 cardinal symptoms of PD last March. There were a number of concerns about the study raised by statisticians such as inadequate controls and full approval was contingent on submission of additional data. I was told that Medtronics has not submitted data requested by FDA including information on the cases that dropped out of the study. I hear PDF and NPF have merged. How about getting them involved in the idea. And APDA too. There is precedence for close cooperation among all the PD organizations. We all hope that the national PD organizations will consolidate, but the merger is not finalized. If the National Orgs recommend a "citizens committee" it might bear weight with FDA. Let me know if there is ANYTHING I can do to help. I have an e-mail Activist mailing list of over 400 PAP. Anyone else got some ideas on this? Let's hear them! Thank you for your advice and support. I will certainly call on you as I figure out how to proceed on this project. Perry