 |
 |
 |
 |
 |
 |
 |
 |
 |
 |
 |
 |
 |
 |
 |
An Inquiry into the ImClone Cancer-Drug Story
Subcommittee on Oversight and Investigations
Dr. Laurie Smaldone M.D.
Thank you, Mr. Chairman.
My name is Laurie Smaldone, and I am senior vice president of Worldwide
Regulatory Science at the Bristol-Myers Squibb Pharmaceutical Research
Institute, and a physician specializing in oncology. I have been with Bristol-Myers Squibb for 17 years, and
before that I was an oncologist in academic practice.
While the scope of my responsibilities at Bristol-Myers Squibb crosses
therapeutic lines, a great deal of my professional experience has been in the
area of cancer and, more specifically, cancer treatments. I
am pleased to have this opportunity to address the subcommittee, as well as
respond to its questions, about Bristol-Myers Squibb's commitment to the
anti-cancer agent Erbitux. First, I
would like to say that - from a scientific and clinical perspective - we
believe that Erbitux is an active anti-cancer agent. Evidence suggests that Erbitux shows anti-tumor activity in
patients with late-stage colorectal cancer that is refractory - or, in other
words, unresponsive - to available treatments.
These are patients who otherwise have few if any treatment options
available to them. We believe this
about Erbitux now, just as we believed it when we invested in ImClone Systems
and entered into a commercialization arrangement with ImClone relating to
Erbitux back in September 2001. It
is important for the subcommittee to understand that the disease for which
Erbitux is being investigated as a possible treatment - advanced refractory
colorectal cancer -- is particularly insidious. For individuals diagnosed with it, the prognosis is
generally grim. Still, many
patients are desperate for any treatment that will give them additional time
with family and other loved ones. And
in some cases, Erbitux has helped provide this additional time. While
the difficulties in finding adequate treatments for cancer are well known, it is
useful to point out that great progress has been made in understanding the
course and complexities of cancer. Nonetheless,
beyond early detection and surgical intervention, major impact with chemotherapy
and biologic therapies is limited, and still most tumors go undetected until
quite an advanced stage. As the world's leading
provider of cancer therapies, Bristol-Myers Squibb has focused much of its
research and development on finding better treatments - more targeted and less
toxic therapies than those currently available.
And our strategy also has been to look outside our company for promising
compounds such as Erbitux, which itself represents a new and potentially
revolutionary way of fighting cancer through a more targeted approach. Still, we realize that these advances - while significant
- are not the "magic bullet" against cancer, but they represent real
progress. My
second point is that it is important - in the midst of all the issues
identified - that we together find a way to address these issues and make
Erbitux available to patients as quickly as possible. That is why we are working closely with ImClone to resubmit
the application for Erbitux to the U.S. Food and Drug Administration as soon as
possible. While some patients have
been able to benefit from Erbitux in clinical trials and compassionate use
programs, we know that only after approval and commercialization will all those
who truly need the drug actually get it, and will physicians be able to further
evaluate its role in different clinical settings. Finally,
I wish to stress that this is about everyday people from all walks of life -
thousands of them each year - who one day go to their doctor or to the
hospital and have their entire life turned upside down by a diagnosis of colon
cancer or other solid tumors. For
these people, Erbitux is not an exciting scientific advance or a compelling idea
or a promising investment. It's a
way to have more time. I
can say this with some conviction because I had the honor recently of meeting an
Erbitux patient who told me quite candidly what the drug has meant to her.
And she has permitted me to share her story with the committee, which I
will do now, briefly. A
little over a year ago, when she was 38 years old, Michael Ann Mullinix of
Belvidere, Illinois, was told by her doctor that she had stage 4 colon cancer
that had spread to her ovaries. Even
with surgery, she was given just 9 months to live. A wife and a mother of teenage children, Michael Ann decided
she was going to fight the odds by going on an Erbitux regimen, which she had
heard about on television. Following
surgery, she began treatment with Erbitux and other chemotherapeutic agents last
August as part of a clinical study. And
as of today, she is essentially cancer free. In
the course of our conversation, Michael Ann told me that she was worried.
Not that her cancer would return, or how she was coping with this serious
illness. She was worried about the
future of Erbitux - about its continued availability as a therapy alternative,
not just for her benefit but for many others who would potentially benefit from
it as well. And when she heard that I was coming to testify before this
subcommittee, she asked me to convey the message I have stressed several times
in this statement: we need to work together to do all we can to get Erbitux to
all the patients who need it as quickly as possible. I
should point out that there are risks involved in this project, just as there
are risks in all biomedical research. We
have no guarantee that Erbitux ultimately will be the important therapeutic
advance we expect it to be. But
knowing what we know about it today, there is every reason to be hopeful about
its promise and to move forward with the clinical development and registration
process. Once again, I am grateful for this opportunity to address the committee on this important subject. I'll be happy now to answer any questions you may have.
|
|||||||||||
|
