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."
>>
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