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June 8, 2005
Linda Herman, Parkinson Pipeline Project

Court ruling denies patients compassionate use of GDNF

I read the news stories over and over, shaking my head in disappointment and disbelief.  I  thought the Amgen case would have ended differently.

I suppose I imagined a Hollywood ending in which the judge after meeting Robert Suthers and Niwana Martin  and hearing their stories,  would have ruled on this case beyond the restrictions of contract law. I thought he would have considered the viewpoints of the trial doctors who believed  their patients improvements were due to GDNF, not  a placebo effect as Amgen claimed. I thought he would have given some weight to the FDA’s conclusion that the trial did not need to be stopped  due to Amgen’s claim of possible safety issues. I imagined he would have realized that these patients lives were already in danger – that the known risks of living with advanced PD are far more life threatening than unproven side effects.

I thought Judge Castel would have been touched by the plight of these patients and the law suit against Amgen would have ended  differently.

At other times I imagined that Amgen executives would  have been moved by the sea of appeals from the Parkinson’s community on behalf of the trial participants. I hoped CEO Kevin Sharer would have met in person with the GDNF patients and their families, as they requested. After seeing up close the effects of advanced Parkinson’s on their lives since Amgen halted their treatments, I thought he might have reconsidered his decision.  Since the company tries so hard to project a public image as a business that cares about people, I thought that in the end Amgen would have done the right thing.

But this is real life, not a movie, and the GDNF patients continue to deteriorate. I can only imagine how demoralizing and maddening it must be to know a treatment exists that could help you be able to move again; to have a chance for a normal life again, and to be denied that treatment. There are no new, wonderful drugs waiting in the wings to save the day.  Other researchers are looking into alternative delivery systems of GDNF, which many still consider to be promising. But it will be years before these will be ready for clinical trials.

It should have ended differently.

The GDNF trial participants have taught us that patients must be more proactive and need to defend our rights. Although we were not able to affect Amgen’s view of corporate responsibility or the outcome of the lawsuit, we can work together to help insure that this never happens  again to Parkinson’s patients.  We can educate  pharmaceutical companies about treating human research participants with respect, or they will find it more and more difficult to recruit human subjects in the future.

A  statement of principles to protect human subjects in clinical trials – the Research Participants Bill of Rights  - is being developed by the Parkinson Pipeline Project, in conjunction with the Parkinson’s Disease Foundation, so that in the future, situations such as this one WILL end differently.

Then again, perhaps the GDNF issue has not ended after all.





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