Hi Boann,

The comment about the patients not believing they are worth it for no profit was concerning the overall, pervasive attitude[ and it's easy to see why it exists!] that you can't fight something as powerful as the largest bio tech and even an attitude of "why should we?" It is so competitive, it costs the companies so much money to produce a treatment - they have to do what they do - all true up to a certain point.

I believe we should fight even the largest bio tech in this type of circumstance, however, even if it is only to prevent it from happening again. Patient participants in this study, along with patient advocates, with the counsel of some of the researchers involved in the study, simply cannot see evidence of safety problems with this drug in humans. Some had been on it for almost 3 years.

Great lengths have been taken to check other primates involved in preclinical study [not by Amgen] - no adverse effects.

Other than antibodies, which Amgen will not confirm or deny were caused from dislodged pump/catheters, there have been NO ADVERSE EFFECTS in humans. I personally know one patient whose antibodies went away as soon as her treatments were halted. My personal belief, from everything i have researched, and that includes talking directly with most of the trial researchers pro and con regarding the halt, that the antibodies were not a major concern.

Humans do not need to be given the high dose that produced lesions in 4 monkeys. There have been no lesions in humans.

So here we have a substance, that granted is a bit of an experience to deliver - surgery to install pump and catheters, that patients have been taking for 3 years with NO ADVERSE EFFECTS, that some patients, from taking it, swear they have felt like they were cured, that has caused dyskinesias to go away, medication to be greatly reduced and some eliminated, and last but not least, which requires surgery far less risky than DBS and is regenerative, sitting on a shelf because Amgen says it isn't safe, it isn't effective, it's just placebo.

They will not release their toxicity reports, claiming they will be published. I will just mention here, that sloppy reporting gets rejected, then they have to rewrite, sometimes more than once before it gets published. We haven't gotten to that game yet that I know of; I don't think the results have been submitted to any journals yet.

Tonight in the UK, the GDNF trial participants, all of whom in Phase I showed improvement, are getting together for a reunion. We sent them a message of encouragement. If they care enough to do this, what does it say about their lives? What does it say about this treatment? They still want it back......they know it works.

Paula