Sally Urbaniak's Testimony Before the FDA's Blood Products Advisory Committee - May 2 2008

Anthony Castaldo's testimony
Sally Urbanek's's testimony
Janet Long's testimony
Michelle Williamson's testimony
Dr. Barakat's testimony
Beth Mercante's testimony
Tracy Conaway

Good morning, my name is Sally Urbaniak and I live in Jacksonville, FL. I also very much appreciate having the opportunity to address the committee and FDA staff. I have no financial ties to Lev Pharma and I am not a shareholder. The HAE Association paid for my travel here today.

I am going to take a slightly different approach during my time with you this morning.

Let me start by asking each of you to step out of your role as medical professionals and for the next couple of minute’s think of me as your sister or daughter.

I cordially ask you to spend a few moments living the life of a severely affected HAE patient.

Imagine waking up one morning and as you get out of bed, you realize your feet are so swollen that even a short walk to the shower is going to be painful. When you stand up, your feet feel like they are ready to explode from supporting your body weight. Soon you have no choice rather than get moving, because a sharp, knawing pain in your stomach signals a sickening and urgent need to throw up.

The fluids which caused the swelling, leaked out of your circulatory system and your blood pressure is very low. The lightheaded, faint feeling you are experiencing makes you wonder if you will even make it to the bathroom before passing out.

You want to ignore the dangers of not seeking medical help for what you know is going to be a miserable attack. You want to just stay home and tough it out, but then the next wave of excruciating pain hits and your spouse intervenes and convinces you to make yet another trip to the ER for fluids and pain medicine.

You are so weak you can barely muster the strength to call in sick at work, but you have to, and when you do, you can sense your boss’s frustration by the tone of his voice because this is the second time you’ve called out sick in the past week and a half.

On the way to the hospital, you start thinking of how you are going to handle the ER staff’s not so subtle questions that all but directly accuse you of being a drug seeker. You feel so weak and sick at this point but you know the endless questions are coming.

Before you even arrive at the hospital, your swallowing becomes more difficult and it feels like your throat is swelling. You’re somewhat content that the car is dark enough so your spouse doesn’t notice how frightened you are of your throat closing.

When you arrive at the ER, you say a silent prayer that the next 72 hours will not be filled with the fear of a doctor having to cut a hole into your windpipe because your throat has swollen shut.

Ladies and gentlemen, this represents my life before becoming part of the HAE Association program with the C1 inhibitor.

I am the poster child for demonstrating the true impact of access to c1 inhibitor therapy.

The c1 inhibitor product has totally transformed me and my family. This amazing medicine has allowed me to once again pursue my career, and be a wife and mom.

Thirty years of safe and effective use in Europe and two successful U.S. clinical trials provide overwhelming evidence that cannot be denied. I urge the committee to vote yes for approval and ask the FDA staff to expedite licensing this incredibly safe and effective life saving and life giving medicine.