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FYI, Here's the form letter Amgen sent in response to my complaint about them pulling GDNF: Thank you for your email with regard to the "60 Minutes" segment that aired on Sept. 11 about Amgen's decision last year to stop providing Glial Cell Line-Derived Neurotrophic Factor (GDNF) to the 48 Parkinson's disease patients in clinical trials. We regret that "60 Minutes" chose not to tell the whole story about our decision to halt the trials on GDNF, an action that was endorsed by dozens of independent, outside doctors and medical ethicists who reviewed the data on the study. Our decision was based solely on our concern for patient safety. We took this difficult action when we discovered that the drug might cause permanent harm, complicating an already horrible disease. Prior to making this final decision, Amgen executives consulted international experts in the neurology field and other physicians working with Parkinson's, a number of representatives of the patient advocacy community, and various bioethicists. We also spoke with study investigators, patients and the FDA. Among the findings reviewed by the group was data showing that the drug had significant potential safety risks and that it was ineffective. Indeed, of the seven patients who demonstrated improvement, four were receiving a placebo. As a company dedicated to providing human therapeutics that benefit people, it is our responsibility to ethically develop therapeutics that "first, do no harm" to patients. Given the safety and efficacy information we have about GDNF, we made a science based decision and cannot ethically continue to administer it to patients. We know that some of the study patients desperately wish to continue this treatment and we share their disappointment. However, we cannot in good conscience provide GDNF to these patients given the absence of proven benefit and the potential safety risks, including irreversible brain damage. Continuing to provide the drug could create false hope and deter patients from pursuing potentially helpful therapies that are already approved by the FDA and are now being used successfully by thousands of patients suffering from Parkinson's disease. We are very much committed to additional research that will help us understand the potential of GDNF in the treatment of this terrible disease. For instance, we have worked to make Amgen's GDNF and other proprietary GDNF-related materials available to qualified pre-clinical researchers; we have been pursuing publication of both the Phase 2 study and toxicology data so that we may further our understanding; we are committed to continuing to follow these study participants who have been exposed to GDNF for long-term safety monitoring; we are working with others to explore potential novel delivery methods for GDNF such as viral vector technology and cell-based approaches. In addition, we are continuing to research other potential new therapies for neurodegenerative diseases including Parkinson's disease. Our hearts truly go out to the brave trial patients and their families who had such hope for this experimental drug at this time, but it is clear that more pre-clinical work is now needed. -----Original Message----- From: Parkinson's Information Exchange Network [mailto:[log in to unmask]] On Behalf Of Barbara Sent: Sunday, September 18, 2005 9:56 PM To: [log in to unmask] Subject: Re: Difficulty breathing Thanks for your message, what exactly are these exercises, can you email to me please? My father will be delighted. barbara -----Original Message----- From: Parkinson's Information Exchange Network [mailto:[log in to unmask]] On Behalf Of Randy L Vinecore Sent: Saturday, 17 September 2005 11:30 PM To: [log in to unmask] Subject: Re: Difficulty breathing This can be caused by a number of things and can certainly be exacerbated by pd. Consult his neurologist. I spend a great deal of time doing breathing exercises and find that it helps immeasurably. It is one exercise that is easy to do during "off " periods also. \Randy Games to entertain your brain. http://www.stargraphics.com Star Graphics Corp 10943 S Forest Ridge Ln Oregon City, OR 97045 ----- Original Message ----- From: "Arnie Kuzmack" <[log in to unmask]> To: <[log in to unmask]> Sent: Friday, September 16, 2005 7:34 PM Subject: Difficulty breathing. Was: Re: World Parkinson's Congress - Call for Creativ Arts > It may not really be a breathing problem but a blood pressure problem, > which > could be a side effect of his medications. With some meds, when you stand > up, your blood pressure drops. It can be enough to cause fainting and, of > course, the risk of physical injury. (The tecnical name for this is > postural hypotension.) > > In addition to the breathing exercises, be sure to discuss the problem > with > his doctors. > > > ----- Original Message ----- > From: "Barbara" <[log in to unmask]> > To: <[log in to unmask]> > Sent: Wednesday, September 14, 2005 5:16 AM > Subject: Re: World Parkinson's Congress - Call for Creativ Arts > > > Hi Peggy > Just wondering if you can give me some information please. I live in > Perth Western Australia. My Father aged 81 years, has Parkinson's. The > biggest worry he is having is about his breathing. When he stand up from > sitting he becomes very short of breath and thinks he is going to die. > He asked me to find the breathing exercises devised by Abraham > Lieberman. Do you have any idea where I could get these exercises for > him? I would appreciate some information. Thank goodness this > communication is possible. > Many thanks > Barbara > > -----Original Message----- > From: Parkinson's Information Exchange Network > [mailto:[log in to unmask]] On Behalf Of Peggy Willocks > Sent: Wednesday, 14 September 2005 10:21 AM > To: [log in to unmask] > Subject: World Parkinson's Congress - Call for Creativ Arts > > _____ > > In February 2006, the first World Parkinson's Congress will be held in > Washington, DC. The brightest scientists, clinicians, support > professionals > and many other personalities from the Parkinson's worldwide community > will > come together for this exciting event. Part of the highlight of the > congress > will be a creativity exhibit of various arts created by PWP's. > > We need for all of you creative people to submit your artwork by Sept. > 21 > (paintings, sculpture, quilting, cross-stitch, etc. AND creative > writing, > poetry, website design and other things.) > > See the link here for details: > <http://www.worldpdcongress.org/> http://www.worldpdcongress.org/ > > Don't delay - do it today! > (Hey - I'm a poet! lol) > > Peggy > > > > > ---------------------------------------------------------------------- > To sign-off Parkinsn send a message to: > mailto:[log in to unmask] > In the body of the message put: signoff parkinsn > > ---------------------------------------------------------------------- > To sign-off Parkinsn send a message to: > mailto:[log in to unmask] > In the body of the message put: signoff parkinsn > > ---------------------------------------------------------------------- > To sign-off Parkinsn send a message to: > mailto:[log in to unmask] > In the body of the message put: signoff parkinsn ---------------------------------------------------------------------- To sign-off Parkinsn send a message to: mailto:[log in to unmask] In the body of the message put: signoff parkinsn ---------------------------------------------------------------------- To sign-off Parkinsn send a message to: mailto:[log in to unmask] In the body of the message put: signoff parkinsn ---------------------------------------------------------------------- To sign-off Parkinsn send a message to: mailto:[log in to unmask] In the body of the message put: signoff parkinsn