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Sid Levin wrote >But what we can do -- Is give our PWP representative on the FDA panel any and >all the support we can. Perry Cohen is our representative and he wants to >speed things up if possible. The AIDS people have taught us all a lesson. >They did it -- they lobbied and got more funds -- they have improved (Maybe) >the FDA approval system for their meds. We can learn from them. Does anyone >know any of their politically active people. Let's meet with them and learn >from them. >Perry Cohen wants our help. Perry -- What can we do to help you? I don't know yet but I appreciate the interest and any ideas you have. I will be talking with other patient representatives when I attend the FDA New Reviewers Workshop, November 15 and 16. This workshop was designed to provide new FDA drug reviewers an overview of the FDA drug review process. Some of the topics that will be discussed include: * Drug Development and the Role of the Reviewer * How Drugs Get Approved * Clinical Trials and Statistics * The Advisory Committee Process Judith Richards wrote: > Mirapex and Ropinirole were FINALLY added to Ontario's formulary lists >this past Spring. I thought that Ontario was the ONly province that had >not added these two drugs. > With the 'sudden sleep' side effect, many PWP around here had to go >off Mirapex/Ropinirole or risk having their driver's licence taken >away...one step forward, two steps back... I no longer get sleep attacks, since I take ritalin. So I have come full circle since this is what started me on this kick. (more on ritalin which has helped me greatly in a separate posting) It turns out that ritalin is an exclusion criterion for participation in the phase 2 clinical trials, for which I was otherwise qualified, now starting on the promising Amgen-Guilford neuroimmunophillan medication (formerly GPI 1046, now NIL-A) Even though ritalin leaves your system within hours, the exclusion criterion was 6 months which eliminated me from the study. I became concerned when my doctor indicated it may be 6 or 7 years until this new drug got on the market. At the same time there was news in "Science" of successful use of gene therapy using viral vectors to deliver GDNF to the brain. Well, GDNF is also owned by Amgen who previously failed in clinical trials that were attempting to inject it into the brain through a shunt drilled in the skull (not a pretty picture). What are the chances that Amgen will pursue the findings from the recent publication while they are already invested in a similar treatment. It took several years to start the neuroimmunophillan trials after the original research was published. When several PD advocates met with Dr. Harold Varmus, then Director of NIH, last year, he suggested that we lobby industry as well as government. I thought he was trying to get us off his back, but now I see the importance of this strategy. I'd like to consider other approaches also, but I think a petition to Amgen to recruit patient representation in the design of clinical trials could be beneficial. I understand that an expensive and time consuming element of clinical trials is the process of recruitment of subjects, particularly the increasingly stringent rules for providing informed consent and privacy rights. Patient representation might facilitate this process to save time and money. Perry Cohen