At last, the GDNF story in print and available on Amazon.

http://www.amazon.com/Monkeys-Middle...2156521&sr=8-1

Paula

Editorial Reviews
Product Description
Some said it a miracle drug; others called it the cure. A drug knowns simply as "GDNF" seemed to do the impossible by actually reversing the effects of Parkinson's disease. The miracle ended in the fall of 2004 when Amgen Inc. abruptly halted clinical trials of GDNF and denied access to the drug. In "Monkeys in the Middle", investigative reporter Nick Nelson recounts the true story of the brave patients who took on the world's biggest biotechnology company for the right to be kept alive.


Clinical Trial and Aftermath History

Overview of GDNF

Amgen Halts GDNF Trial: What’s All the Controversy About?

Questions and Answers on GDNF

In the News


The Legal Challenge

GDNF Research History

Response to Trial Halt

• Trial Participants' Responses
  
• Grassroots Responses - 5/22/2006 Pipeline urges Amgen's Board of Directors to take action. On May 5th, GDNF advocates sent the following letter to Amgen’s Board of Directors and CEO Kevin Sharer, requesting specific action from sponsoring company Amgen. No reply has been received as of May 22, 2006. READ THE LETTER
  
• PD Organizations Respond
  
• Trial Doctors Respond: Trial doctors and researchers: dramatic improvement seen in patients

9/11/05 60 Minutes Segment on GDNF

Hi all:

just looked to see if Amazon Canada had the book in stock, but they don't. If you order it be sure you've got the right book as there is a book titled "Monkey in the Middle". You want the one by Nick Nelson.

If you read the book (I already have), post your thoughts on it here so others can exchange their thoughts. There are probably new people on the board who have arrived since the GDNF fiasco. Especially people who don't live in the States.

Carolyn: I notice you have a link to the 60 minute segment...Anyone who hasn't seen it definitely should!

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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Hi DJM,

Are they still working to comply and get it approved? We are looking for the latest information. Jaye, if you are reading maybe you can add something - Jaye is in the Johns Hopkins study with it.

By now, I realize that we just don't look sick enough on the outside far too long for people to understand just how sick we are. We quit our jobs but don't get approved for social security. I'm not sure you can measure it exactly. You may know that you feel better, but it doesn't necessarily show in the doctor's office. And of course, they don't take the participants word for it - but call it placebo.

This is the link I have on it -
http://www.kyowa.co.jp/eng/netext/er080228_01.htm

DJM, my heart goes out to you. I hope there is still a chance for it and it doesn't get stuck in the FDA black hole for too long. There is a push for legislation for better access; as they say on the fastercures.org site - "something's got to give."

These are humans, not animals. Humans know what they are being denied and why. It absolutely stinks.

paula

Thanks Paula and Carolyn. How can one not be a bit cynical? For gawds sake no-one can tell us what is the best treatment, or recovery techniques for pd are. When I was diagnosed I was told to stay off the Internet as most the information was way out there.............I guess the silly book on keeping my sexuality alive and pd information pamphlet I got was all the info I needed, in there minds.

haha.....good one SCR.

paula

I was in for my regular checkup on April 1, nothing different except the cards showing on-off-dyskinesia for two days in the week prior. As it happened I was off a LOT those two days, but am better now since my neuro added Amantadine. I would certainly miss the KW6002 if I couldn't have it any more. I think I'm on my fourth year of it. My Hohn and Yaar has gone from 3.5 back to as low as 2.0.

The first thing the PI said to me when describing the study was that I might have to go off the drug at some point. I knew it from the first and I signed the paper that said I accepted that. There's never a convenient time to go off anything.

Anyhow, I did it for Science and for my fellow PWPs. No foolin'.

Jaye

I tolerated Istradefylline well. I took it at 0600 and my best time was in the mornings. Apparently it is different than agonists in that it makes your brain think it is producing it's own dopamine. I would definitely be taking it now if it was available.

I continue reading Howard Brody's book"Hooked: Ethics, the Medical Profession, and the Pharmaceutical Industry" (Rowan & Littlefield Publishers, Inc, 2007) Dr. Brody has an MD and a PhD in Philosophy, evident in his writing, ie dense stuff at times.
He notes the passage of the Byah-Dole law in 1980. This law was passed based upon a study in the 1970's, showing that of the 2800 patents held by the US govt and its scientists, only 5% had been licensed to manufacturers. The inference was that these discoveries needed to be moved from the laboratories into industry in a more "streamlined" way (p.75). With passage of this law, universities and the NIH could patent scientific discoveries and grant exclusive manufacturing to pharmaceutical firms to produce the final products. The law included a clause for "reasonable pricing". If a pharmaceutical co developed a product from that which was developed and patented by the federal government, the price of the product must be "reasonable" or the government had the right to repossess the exclusive patent rights from the company. This was termed the "march-in rights".
Brody notes that there was not much use of the Bayh-Dole law until 1995, when the NIH "dropped the reasonable-pricing requirement altogether" (p78). In 2002, 2 Washington Post reporters, Peter Arno and Michael Davis, wrote an article noting that the Bayh-Dole provision should give govt a way to make drug pricing reasonable. Senator Bayh reported at this time that his interpretation of the "march-in-rights" was not to affect drug pricing but to force drug cos who had been given exclusive rights to manufacture a "useful" drug and then failed to bring the drug into production to give the "public access to the new drug---at whatever price the company decided to charge" (p. 79)
I assume in all the legal back and forth with Amgen, the use of the "march-in-rights" was considered....just noodling here...The author notes that the NIH dropped the "reasonable pricing" provision--he does not state that it was repealed.....Perhaps an inquiry to either or both of the Washington Post reorters might be in order. madelyn