Friday, July 22, 2011

Berlin Heart On the Way to FDA Approval

Berlin Heart goes before the approval panel for FDA recommendation in D.C. and they hear Bailey's story!

What a day! Bailey and I left Indy airport at 6:20am. Arrived safely at BWI (Baltimore/Washington International) Airport almost 2 hours later. Wondering where our driver will be, my phone rings and its him telling us what door he was parked by. Then we see a "Hunsberger" and a "McGraw" sign. It's a strange feeling in today's world getting in a car with a complete stranger who barely speaks English.

We have lots of time because we don't talk until 1:00 so getting stuck in rush hour traffic is no big deal. We arrive at the hearing site (the Hilton) just outside of DC. Spot a Starbucks and grab a snack. We sign in at the Public Hearing/Speaker desk and get to sit in on the last morning session. The room is quite intimidating and the schedule is very regimented. We receive a set of conduct guidelines and aren't allowed to speak until spoken to, basically. Berlin Heart's presentation was earlier in the morning, so we missed it. The FDA presented their findigns and the numbers and medical jargon were quite "blinding" to us. We followed enough to tell that the panel wanted to see results that included long-term survival rate and progress. Well, the study has only been going on since 2007, so there weren't many long-term numbers to report. That's when I decided I needed to tweek my speech a little bit to give the panel an accurate picture of how well Bailey's doing 6 years after her experience with the Berlin Heart.

We broke for lunch. Bailey and I grabbed a sandwich at the hotel restaurant, and I tweeked my speech, as the Berlin Heart crew ran off (literally) to compile some more numbers and statistics for the panel.

Just before we went back in to present Bailey's story, we got to meet the Berlin Heart group from Germany! They were so grateful and kind to us and couldn't wait for us to put a human touch to all the numbers and statistics. I asked them how the morning went, and they said "It went ok. But wait til they hear about Bailey." They're great guys! I got to tell them about the run-in we had in Albuquerque last fall with the big red heart-shaped hot air balloon from Germany and that none of the crew or pilot spoke any English. They thought that was really incredible and couldn't believe none of them spoke English!

There were only 4 speakers during the public hearing - there was 1 other patient represented and 2 cardiovascular surgeons - one from Philadelphia and one from Michigan. Bailey and I started the session. She did awesome! My heart was pounding out of my chest! It was really strange - this is the first time I spoke where I wasn't scared to death - but I was incredibly excited. I startd to speak and got a little choked up a couple times but could keep going. I had to stop for reassurance from Bailey when I told them about our awesome hot air balloon pilot we crew for! A picture of Mark and Alora popped into my head and I just wanted to give them a hug! They've been a HUGE support to us along with the rest of our balloon family! The panel spokesman thanked us for our time and appreciated the emotion and the human touch. The next speaker was a dad and little brother of a girl on the Berlin Heart in Delaware. Her name is Josie! and she's been on it for 9 months now waiting on the perfect heart. It was so hard to hear her dad speak. Such a raw experience for them right now - not knowing how long they'll have to wait, praying for the donor and their family, and knowing another open heart surgery is just ahead for them. The 2 CV surgeons did an incredible job. Neither one was a part of the study, but they reported valuable findings on their patients including number of deaths, number of transplants performed, number of clotting issues, etc. One of them pointed out the death rate seems kind of high but when you consider these critically ill kids don't have any other alternative because they are going to die without this chance, the numbers begin to look quite good! Wow.

None of us were questioned by the panel (22 very serious and scary looking men and women who used a lot of BIG words), but we were all thanked for our input. We then left - we didn't really care to hear anymore numbers and criteria. We were very happy with our presentation, and did all we could do. The rest is up to the professionals.

We ran out into the 250,000 degree parking lot to catch Josie's dad and brother. We exchanged hugs and smiles and compliments for our jobs well done. We told him we would pray for Josie, so if any of you want to join us in that endeavor, we would all appreciate it! Such an awesome family. (I reserve the word awesome for extraordinary situations. I've used it a lot today!)

So we have 3 hours to spare before our car returns to take us back to the airport, so we go sit in the hotel lobby while the deliberations continue behind closed doors. We thought our day was pretty much over.

We are first greeted by a couple different people telling us we did a great job and how brave we were to present Bailey's store before a bunch of scary people. Ha! Then, a man from some American Blood & Something introduced himself and explained that his company is working on an American version of the Berlin Heart and hopes to be before this panel in 4 to 5 years. He said that Berlin Heart has been working with them to develop the device and their relationship is not a competitive one since these devices are not profitable (there's not enough demand for that) but there is definitely a proven need for the device, so they and Berlin Heart are doing it strictly for the kids! Very impressive. I got to thank him BIG too!!

Then! The most exciting introduction of this whole day - a man came up and told us he was with the FDA back in 2005 and he is the one who granted the compassionate use of the Berlin Heart for Bailey! He personally worked with Dr. T to make it happen! He definitely got the biggest hug of the day and I took his picture with Bailey. How awesome is that?! (There's that word again.)

And finally, one of the panel members himself came up to us and thanked us for putting a human touch on all the numbers. He was sure it was not an easy thing for us to do but he appreciated it and thought we did a fantastic job. What a compliment that was coming from one of the big-scary-people-who-uses-lots-of-words himself.

Then we climbed into another car with another stranger and said a prayer that he was taking us to BWI airport. [fingers crossed!] We sat back and relaxed with BIG smiles on our faces.

Now we're back on the plane and headed home. Just before we had to shut our phones off, we get a text from Dr. Cox saying "It was a unanimous vote! They said yes to every question!!!! Congratulations and thank you for all your help!!" Now picture us in the middle of the airport gate not being able to jump and shout for fear we'll be carted off by the TSA, but wanting to do exactly that. Heehee! We settled for tearing up and hugging one another.

Hallelujia and thank God! The Berlin Heart is well on its way to being approved by the FDA (which is expected to become final in the next few months) and can then be at the hospitals waiting for the kids who need it instead of the other way around and having to keep fingers and toes crossed that it arrives from Germany in time to save a life. It's going to live right here!

Thank you to all of you who have been a huge support to us!!
We love you all!!

Angie and Bailey