Originally Posted by DJM1

This is taken from a post I made on another PD forum:

A couple of years ago, I felt so sorry for the Amgen PD trial participants when many who had been helped - not harmed - by it demanded the right to continue to receive the treatment. And that's where I am now - dreading the end of the study I'm in next month.

The KW-6002 (Istradefylline) drug study began as a double blind event for me. And, from the very first dose, I felt so much better that it was obvious to everyone that I was getting the real drug - not a placebo. The experimental drug has helped me so much. When the qualifications for being in the study changed and I no longer qualifed to be part of it, my daily functioning declined considerably. The dramatic change in my well being on vs. off the drug led me to the decision to have surgery so as to once again qualify for the study. Yes, this drug helped me so much that I had surgery so that I could once again be part of the study!

Nearly two years (or is it three?) of taking this med and I have had no negative reactions and a noticeable imiprovement in my daily functioning. Despite this drug helping me and a lot of other PD patients that I've spoken with, the study will end and the drug will no longer be available to me - to us - as of next month.

QUOTE:"The option for participants in the experimental/treatment group to continue the treatment. Likewise, those who received placebo or low dose treatments, or sham surgery should have the option of receiving the experimental treatment at the full dose, upon conclusion of their trial."

If I understand the quote above taken from the proposed Trial Pts Bill of Rts., this bit means that drug study patients could opt to continue to take the study drug after the study ends and the study's sponsor would have to continue to produce the drug in quantities large enough to meet trial participant needs. I'm all for that!

I would sign whatever waiver they came up with to protect the drug company doing the study, but I should have the choice to continue the drug or not. This choice is not mine - I have no say in it. I think the purpose of the Trial Patient Bill of Rights is very necessary.

Considering this experience, will I participate in other drug studies that may arise? Maybe. Maybe not.

The end of this drug study is not only my personal loss, but considering the difference it made in my well-being, I think it's a huge loss for the PD community as a whole.

"Monkey in the Middle" seems a very appropriate name for a book about the Amgen trials.
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