Linda   -

Have you had much response from people in other countries writing letters to
Amgen?  Would it help if we encouraged Australian pwp's to send letters?

kind regards
Kay Messiter
----- Original Message -----
From: "Linda J Herman" <[log in to unmask]>
To: <[log in to unmask]>
Sent: Thursday, February 17, 2005 7:36 PM
Subject: NEWS Article: Amgen Drug is Said to Work


> FROM: LA Times, Feb 17, 2005
>
> Amgen Drug Is Said to Work
> A study says the trial Parkinson's treatment improved motor function,
> contradicting the company's research.
>
> By Denise Gellene, Times Staff Writer
>
> Just days after Amgen Inc. said it would stop supplying patients an
> experimental drug for Parkinson's disease, a research team from the
> University of Kentucky reported in a medical journal that the medicine
> worked in a clinical trial.
>
> Don M. Gash, an author of the study, said he hoped Amgen would reconsider
> its decision and provide the trial drug to 48 patients who participated
> in company-supported studies. Many of the patients have been lobbying
> Amgen for the drug, which they see as their only hope.
>
> "Controversy can be good if it can get people not to take a rigid
> position and not to create barriers," Gash said.
>
> Amgen spokeswoman Marie Kennedy said she was not aware of the study.
>
> Last week, Amgen said it would no longer provide the drug to patients
> because its studies showed that it did not work and might cause permanent
> harm. Kennedy said Wednesday that the company hadn't abandoned its
> research, and would continue to support laboratory studies of the drug by
> academics.
>
> The study, published in the Journal of Neurology, reported that 10
> patients who had received the drug, known as GDNF, had an average 30%
> improvement in such areas as balance, gait and speed of hand movements.
> The study followed the patients for six months.
>
> However, seven of the 10 continued to receive GDNF for a full year before
> Amgen stopped providing the medication. Those patients further improved
> and saw a 45% increase in their motor function, Gash said. "It is the
> difference between being wheelchair-bound and being able to walk for
> several miles," he said.
>
> Researchers saw no signs of brain damage that Amgen observed when the
> company tested high doses of GDNF in monkeys, Gash said. The monkeys were
> given six times more drug than patients in the University of Kentucky
> study.
>
> "The difference between poison and medicine is the dose," Gash said. "The
> patients did very well and the side effect profile is excellent."
>
> The report said researchers could not rule out the so-called placebo
> effect in which the process of being treated, rather than the drug
> itself, causes patients to improve.
>
> An earlier Amgen-sponsored trial of 34 patients ended in disappointment.
> The company divided the patients into two groups - half received GDNF and
> the rest were in a control group given saline solution. At the end of six
> months, Amgen concluded that GDNF was no better than a placebo.
>
> But Gash said there were differences between the two studies that might
> explain the results.
>
> All patients received GDNF directly into their brains through tubes
> connected to pumps implanted in their abdomens. In the University of
> Kentucky study, the drug entered the brain in bursts through a catheter
> with 40 holes that Gash likened to a "soaker hose." Amgen used a catheter
> more like a garden hose that delivered the drug in a continuous drip.
>
> Gash said he has discussed his findings with Amgen scientists. "We
> certainly wish Amgen would reconsider," he said.
>
> http://www.latimes.com/business/la-fi-amgen17feb17,1,865660.story?coll=la
> -headlines-business&ctrack=3&cset=true
>
> ---------------------------------------------------------------
>
> Additionally a two year follow up of the Phase I study in Bristol, United
> Kingdom has been published in Annals of Neurology, February 2005 issue
> --  " Intraputamenal infusion of glial cell line-derived  neurotrophic
> factor in PD: A two-year outcome study",   Nikunj K. Patel, et.al and
> reports continued improvement  in all 5 patients over the 2 years and no
> serious side effects. The authors concluded, that treatment with GDNF
> resulted in improvement in symptoms AND slowed the disease progression!
>
> ""Our results indicate GDNF's potential as a therapeutic agent in PD,
> from its ability not only to provide symptomatic relief, but also to
> possibly modify the disease state, distinct from other current
> therapeutic strategies; however, continuing dopamine replacement therapy
> was required. The early onset of symptomatic improvement, accompanied by
> an increase in 18F-dopa uptake immediately surrounding the cannula tip,
> seems compatible with a functional upregulation in residual dopaminergic
> neurons. The progressive and sustained improvement in symptomology, and
> increased 18F-dopa uptake throughout the putamen at 24
> months,15 is suggestive of reduced disease progression."
>
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