Monkeys in the Middle

olsen · 06-02-2008, 10:40 AM

The theory that PD is a disease of many different etiologies, the given that some therapies may help one subset of PD patients but not others, would cry out for "compassionate use" of clinical trial meds for that group of patients for whom the drug is effective.
madelyn

paula_w · 06-02-2008, 10:58 AM

Hi Madelyn,

'march in rights' were discussed, thanks for explaining it. I don't know the details about why it wasn't invoked. That might have been on the patient site that is now offline. If i find anything I'll post.

Regarding compassionate use - the FDA left it up to Amgen. FDA gave them the OK for compassionate use. It was Amgen's call.

paula

olsen · 06-02-2008, 03:33 PM

Perhaps "compassionate use" should be part of the study protocol? and for those invoking disincentive to pharma to develop new drugs, esp for diseases that occur in less #'s than would make it profitable--remember the "orphan status" drug laws (tax break and 7 yr monopoly on drug sales). and the incredible fact reported by Dr. Marcia Angell (The Truth About The Drug Companies: How They Deceive Us and What To Do About It. New York:Random House, 2004.)that in 2002, a listing of the combined profits of the 10 pharmaceutical companies in the Fortune 500 --$35.9 Billion-- was GREATER than the combined profits of the remaining 490 companies--$33.7 Billion. Dr. Brody lists the above facts in these terms: "...the pharmaceutical industry accounted for 2 percent of the Fortune 500 Companies, but 52 percent of these companies' total profits ." (H. Brody, "Hooked", New York, Denver: Rowan & Littlefield Publishers, Inc. 2007, p. 57)
Granted there were only 10 pharmaceutical cos in the fortune 500 listing, still seems egregious to me.....actually more so.

(i apologize for lack of underlining--I do not have that feature on my tool bar and have no idea how to access it.)

Bob Dawson · 08-19-2009, 07:47 AM

I first heard about Amgen early in 2009. I was in the waiting room of my neurologist:
"...A 70-year-old woman in the waiting room of a hospital in Montréal talked about the Amgen fiasco, and she said “it was the day when they decided to kill the monkeys and send the Parkinson’s patients home to die.”
My website was about Parkinson's and dancing; but Chapter 21 is completely different. I will not let the memory of what happened disappear. I wrote this but I don't know who to tell about it because the chapter is not about dancing. Right now I am alone with this - I found your site by googling around. The software on this site will not allow me to post a link, so just google something like Parkinson's dance Dawson Chapter 21 and you should be able to find it. It's an on-line book.
If anyone is still interested please pass it on or help me find e-mail lists to send it to. I don't expect any reaction - it seems to be a dead issue, but when I found out about it I was very angry, and us Newbies will keep the story going so that the great-grandchildren of the volunteers will know what happened.
Bob Dawson
And this site will not take my e-mail address, or possibly Bill Gates is once again conspiring against me, so you can e-mail me**
Maybe someone still follows this or could update me or something; right now I am alone with it and it makes me boil over.

Jaye · 08-19-2009, 10:14 AM

Here's a link to your blog. Lots to read there. Stick with us, please. Isolation seldom helps any of us.

http://parkinsonsdance.blogspot.com/...r-21_3946.html

Lots to read here, too. By the time you've read everything linked above by Stitcher and others, you will definitely know you're not alone.

Stories, anyone? How about Steve meeting someone from England?

Jaye

paula_w · 08-19-2009, 11:51 AM

bob,

I am one of those acknowledged by Nick in his book because i happened to be in the thick of the amgen debacle. We could match nick's book with another of our own experiences. Remembering exactly when and where i was, just like when jFK was shot, I realized one morning that my generation would not be cured, but much worse - realized that a treament would not be produced unless it was a silver bullet. Canceling gdnf showed the disconnect between helping patients and making money. IF it can't beat or match sinemet in relieving symptoms, will they even produce it? GDNF should be available on the market today.

I've had pd for 20 years and take sinemet every 2 hours. By the end of each day i'm a mess pumped full of all that sinemet. It's the meds that very well might kill us.

But put on music with a beat and i can dance for hours and i do a pretty mean hoola hoop too. dancing is to a pwp like singing is for a stutterer.

say hello to anuket for me. first time i heard her sing and you have a good blog!
read more here: www.pdpipeline.org

here's Andy: http://pdpipeline.org/andygrove/agrove1.htm

video of Andy:
http://pdpipeline.org/andygrove/agrove7.htm

paula

Bob Dawson · 08-19-2009, 12:27 PM

Wow and thank you ! And wow!
An entire universe I did not know existed
It will take me some time to read
and I am too angry to read much
I will calm down in a few days
but I will not be silent
thank you, y'all

stevem53 · 08-19-2009, 12:52 PM

Quote:

Originally Posted by Jaye

Here's a link to your blog. Lots to read there. Stick with us, please. Isolation seldom helps any of us.

http://parkinsonsdance.blogspot.com/...r-21_3946.html

Lots to read here, too. By the time you've read everything linked above by Stitcher and others, you will definitely know you're not alone.

Stories, anyone? How about Steve meeting someone from England?

Jaye

I met, and got to know Jason Isaacs the actor from Liverpool England..When he was in Rhode Island filming the Showtime series "Brotherhood"..I was introduced to him, and on more than one occasion in his company..His chauffer was a good friend of mine..Jason also co-starred with Mel Gibson in "The Patriot" as the English Army Colonel Tavington, and in a number of other films including "Harry Potter" as Lucius Malfoy, and in "Armageddon" as Ronald Quincy

Great guy..Interesting to chat with, and down to earth

So thats my 15 minutes

LindaH · 08-19-2009, 03:51 PM

Bob,

If you haven’t found it yet, the Parkinson Pipeline Project has been compiling informatiom about the GDNF saga since the trial halt in 2004. Many pipeline members joined with a grass rootsl coalition of PWP advocates, , trial paeticipants and their familkies both in the US and the UK, trial doctors to fight Amgen’s cdesisison, reinstate treatment for the trial participsants, and continue GDNF rteasearch . And to get the truth out about these trials. We’ve learned a lot ovr the years about new drug development and research and the need for patients to be involved at every level.

More later, but for now see

The index page is at:
http://www.pdpipeline.org/advocacy/gdnf_table.htm

and an overview is at
http://www.pdpipeline.org/advocacy/gdnf_overview.htm

linda

lurkingforacure · 08-19-2009, 03:54 PM

Quote:

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.
__________________

I have read that the company that was doing the trial is planning on addressing the FDA's concerns and then resubmitting...

"After closely examining the FDA's response, Kyowa Hakko will work closely
with FDA and conduct a comprehensive discussion to determine a path forward for istradefylline (KW-6002)."

From here:http://www.reuters.com/article/press...08+PRN20080228

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