| "In November of 1997,
after experiencing chest pain for several weeks, I went to the hospital
and learned
that I had distal heart disease and blockage in all vessels.
This required that I undergo a 3 vessel CABG (bypass surgery). "I was doing fine, I thought, until
I experienced angina in March 2006. I went again to the same hospital,
and a cardiac cath was performed. Immediately after the procedure
and while I lay on the recovery table with the compress on my groin,
I was introduced to a cardiologist and a research coordinator. They
began to explain to me that the three vessels had closed and that
I required a stent. They recommended, because of the condition of
my arteries, that I elect to participate in a clinical trial with
a new type of stent that released a medicine to prevent clotting.
Did I ask questions? No. Did I fully comprehend? No. I knew only
that I wanted to live.
"They had clipboards and many forms
for me to sign and I signed them all from a flat position on the
recovery table. I was then officially enrolled in the Spirit III
Clinical Trial. Since March of this year, I have had many instances
where I have needed some level of support, especially in the last
few months. With all of the information regarding the safety of
the devices, their impact on those of us with heart disease,
how I am to carry on with my life when I feel somewhat discomfort? This need for support is ever more obvious.
"Only last week, I logged onto MSNBC
and read an article that stated something along the lines of 'Tiny
Time Bombs Ticking in the hearts of patients' and experienced
a fear like none other that I have felt. I immediately called the
telephone number of the Research Coordinator listed on my little
card that I have carried in my wallet since March and…got
her voicemail stating that she was on vacation until the next week,
and was given another number to call.
"What I would like for the panel to
realize from my experience is this very lack of serious support
services available to assist patients who experience adverse emotional
or physical responses.
"Patients report that they get this
device and are left to figure out the rest by themselves. The disconnect
is huge. On my last visit, there were about 300 responses on the
MSNBC Website regarding the fear raised about this stent. The vast
majority of the persons who write have experienced some type of
adverse event, and note the lack of support services.
"Questions go unanswered, other than
a website that I was able to find called Angioplasty.Org, but for
those who don’t have internet access or are just not a part
of the electronic communication generation, please examine how those
patients can also have access to this information and support.
"As a patient with this device inside
my heart, I ask that the panel take under consideration how the
implantation of these devices can be coordinated to also include
the development and provision of compassionate care supportive services
via a provision of information that will reach each patient.
How can these support services not be available and provided? I once read that
fear is false evidence appearing real….if these stents are really doing
what they are supposed to do…please help alleviate the fear that many
persons, such as myself, are experiencing."
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