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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." > > ---------------------------------------------------------------------- > 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