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Patient Stories: Rick Dulin Speaks to the FDA
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In December 2006, Maryland heart patient Rick Dulin read on Angioplasty.Org about an upcoming FDA hearing on the safety of drug-eluting stents. He decided to appear before the regulatory panel and tell his story. Rick knows first hand about the importance of information and support for heart patients. Today Rick is doing fine, and the concerns about the safety of the type of stent he was given have been resolved.

Rick’s willingness to speak out about the fear that sensational media coverage of medical stories can generate, and his call for better education and support for patients made a powerful impact on the regulators and physicians who heard him speak.

Here is part of the story he shared with the panel:

"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."

Reported by the Editors, Dec. 11, 2006 -- revised Sep. 29, 2011, Dec. 11, 2012