"Rick from Maryland" explained
in his presentation that he had signed up to speak on the first day
of the hearings, but was overwhelmed and confused by the discussions
he heard -- he left the meeting before speaking. Angioplasty.Org Editor,
Burt Cohen, contacted Rick that evening and urged him to return to
speak on the second day ."I told Rick that, although I had testified
to the panel on behalf of patients, it was critically important for
the physicians, companies, organizations and regulators in the room
to hear patients' viewpoints."
Mr. Dulin did return and his moving
speech, given shortly before the Panel went into its final deliberations,
provided a powerful closing argument on behalf of patients and elicited
a "thank you for your most eloquent presentation" from the
panel's chairman, Dr. William Maisel. A quote from his speech was included
in an Associated Press article, reprinted around the world.
Good afternoon. My name is Rick Dulin.
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.
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 OR 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 where
the Xience and Taxus stents are being evaluated.
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, and how
I am to carry on with my life when I feel somewhat discomfort, this
need for support is ever more obvious.
On 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. I called it and left a message. The next day someone
called me back, listened to my concerns, and noted that they had
not heard of any issues with the Stent. I asked for the persons email
address and sent an email of the link to the article that had prompted
me to call. I was then called two days later, right before Thanksgiving
by the Research Coordinator and asked if I could come in for a followup
appointment.
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.
Finally, may I suggest that the panel examine
how this highly complex information (for me) can be presented in
a culturally accurate, linguistically diverse, and appropriate literacy
level manner so that support services can be developed and provided
to the entire patient population that have received one of these
stents.
On yesterday, I requested to speak in the unannounced
segment, but I left out of a fear that I experienced on learning
so much confusing information which I know to be indicative of what
others are also feeling based on the posted responses on so many
different websites... I went home and got in the bed.
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.
This will serve as a means of educating those of
us who are living with the fear of not knowing what’s next.
This will also assist physicians responsible for monitoring these
devices. On yesterday I learned that the percentage of Stents implanted
off label was approximately 60% and then I read it in an article.
Today, I am still learning what it actually means.
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.
