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9/11/05 60 Minutes Segment on GDNF

Some people who wrote to Amgen after the 60 Minutes show
received this reply as a .pdf file (9/21/05)*

Thank you for your email with regard to the "60 Minutes" segment that aired on Sept. 11 about Amgen's decision last year to stop providing Glial Cell Line-Derived Neurotrophic Factor (GDNF) to the 48 Parkinson's disease patients in clinical trials.

We regret that ď60 MinutesĒ chose not to tell the whole story about our decision to halt the trials on GDNF, an action that was endorsed by dozens of independent, outside doctors and medical ethicists who reviewed the data on the study. Our decision was based solely on our concern for patient safety. We took this difficult action when we discovered that the drug might cause permanent harm, complicating an already horrible disease..

Prior to making this final decision, Amgen executives consulted international experts in the neurology field and other physicians working with Parkinsonís, a number of representatives of the patient advocacy community, and various bioethicists. We also spoke with study investigators, patients and the FDA. Among the findings reviewed by the group was data showing that the drug had significant potential safety risks and that it was ineffective. Indeed, of the seven patients who demonstrated improvement, four were receiving a placebo.

As a company dedicated to providing human therapeutics that benefit people, it is our responsibility to ethically develop therapeutics that ďfirst, do no harmĒ to patients. Given the safety and efficacy information we have about GDNF, we made a science based decision and cannot ethically continue to administer it to patients.

We know that some of the study patients desperately wish to continue this treatment and we share their disappointment. However, we cannot in good conscience provide GDNF to these patients given the absence of proven benefit and the potential safety risks, including irreversible brain damage. Continuing to provide the drug could create false hope and deter patients from pursuing potentially helpful therapies that are already approved by the FDA and are now being used successfully by thousands of patients suffering from Parkinsonís disease.

We are very much committed to additional research that will help us understand the potential of GDNF in the treatment of this terrible disease. For instance, we have worked to make Amgenís GDNF and other proprietary GDNF-related materials available to qualified pre-clinical researchers; we have been pursuing publication of both the Phase 2 study and toxicology data so that we may further our understanding; we are committed to continuing to follow these study participants who have been exposed to GDNF for long-term safety monitoring; we are working with others to explore potential novel delivery methods for GDNF such as viral vector technology and cell-based approaches. In addition, we are continuing to research other potential new therapies for neurodegenerative diseases including Parkinsonís disease.

Our hearts truly go out to the brave trial patients and their families who had such hope for this experimental drug at this time, but it is clear that more pre-clinical work is now needed.

*9/21/2005 Form letter received by a letter-writer in Chicago via email as a PDF file attachment from Amgen.com. Same letter from Amgen was reported to have been received by many other people at the same time.


Cure interrupted?

9/8/05 (CBS) Parkinsonís patients who say a clinical-trial drug helped them now feel used by the drug maker which is denying them the drug for safety reasons. Correspondent Lesley Stahl reports on 60 Minutes, Sunday, September 11, 2005, at 7 p.m. ET/PT.

Read about Roger Thacker, a GDNF trial participant, who says GDNF was a cure. But having been taken off GDNF, he is now barely mobile.


About the report

Amgen declined to talk to 60 Minutes. However, 60 Minutes reported that they found a statement by Amgen's vice president of research, Roger Perlmutter, on the Internet. His statement comes from a speech from when Amgen's phase two GDNF trial was still under way:

"There arenít enough neurosurgeons in the country to actually do that procedure and there arenít enough neurosurgical suites in which to actually do it. So that would limit you pretty dramatically. This is not a therapy
from our perspective that is going to be a huge moneymaker for Amgen. Itís just, youíre never going to get there."

Read the letter Amgen sent to people who wrote them after the 60 Minutes segment.


Links to past CBS news coverage of GDNF

3/30/03 Parkinson's Drug Shows Promise

4/18/02 New Treatment for Parkinson's Disease


 

Related Issues

Roger Thacker's Story

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