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 “60 Minutes” 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 Parkinson’s, 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 “first, do no harm” 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
Parkinson’s 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
Amgen’s 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 Parkinson’s 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) Parkinson’s 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.
After viewing - take action. Find out what you can do.
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 aren’t enough neurosurgeons in the country to actually do that
procedure and there aren’t 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. It’s
just, you’re 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
What You Can Do
Roger Thacker's Story
Contact the
Parkinson Pipeline Project
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