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I'm still catching onto the debate... What are the key issues in relation to Amgen? Leigh, in Brisbane, Australia. On 18/02/2005, at 10:25 AM, Info at Parkinsons NSW wrote: > 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 > ---------------------------------------------------------------------- To sign-off Parkinsn send a message to: mailto:[log in to unmask] In the body of the message put: signoff parkinsn