Dear FDA...

The FDA (for those reading this outside the US, it stands for the Food and Drug Administration - they are a group responsible for several things, including approving new drugs here in the states) will be holding an Gastrointestinal Advisory Committee Meeting on November 17th.  The meeting will be 9 hours long - which in reality is not a lot of time when you are discussing new treatments or drugs to help a large patient population.  According to G-PACT, this is the first time a meeting of this magnitude is being held in the last 20 years.  Raising awareness doesn't just happen with those around us whom we interact with every day or with the stranger on the street on may approach and ask why you are hooked up to an IV bag - raising awareness also needs to happen in the pharmaceutical industry and with the FDA.

The FDA will be accepting both written and oral statements from the public - an hour of the meeting will be made available for oral presentations from the public (if there are more presentations than time allows, then they will hold a lottery).  While I can't be in Maryland that day to verbally tell the FDA about my experience with Gastroparesis - I can write them a letter.  So here is my current draft letter....

Dear Members of the Gastrointestinal Drugs Advisory Committee,

I want to start off by thanking you for giving the patient population the opportunity to provide personal testimonials about our journey with our gastrointestinal illnesses.  My hope is that after reading and hearing all of our stories, that your awareness of how these conditions affect our daily lives will increase but more importantly that your passion to help find, recommend and approve newer treatment options will be unrelenting.

I am a 38 year old female - who married my high school sweetheart and recently celebrated 20 years with him.  We have two beautiful children - a 17 year old son and a soon to be 12 year old daughter - for whom I live for each day.  I had been training in the martial arts for a couple of years, had quit smoking almost three years ago and just felt like I was in the best shape of my life - really taking care of myself and my body.  Last year however, my life was completely turned upside down - and ultimately my family's as well.

During the summer of 2010, I started to experience severe gastrointestinal issues.  It was a Saturday night and I had eaten dinner with my family after a long busy day.  Almost instantly I began to experience stomach cramps and pain and my abdomen became severely distended and it was difficult to take a deep breath.  Now I had this occur a few times in the past and usually after a few hours I would return to normal, this time that wouldn't be the case.  The distension and the pain would remain for several months and it became increasingly more difficult to eat without further issues.  I soon was under the care of a gastroenterologist at one of our centers of excellence in my home state.

The next few months involved several tests - which would ultimately confirm that I have Gastroparesis, Esophageal Spasms and CIP - but the cause is currently listed as idiopathic.  I have tried a slew of prescription and OTC medications - Reglan, Mestinon, Dexilant, Prilosec, Nexium, Citrucel, Miralax, Probiotics, etc.  All of which were intended to combat one of these gastrointestinal issues that I am dealing with.  Some of them didn't have any effect at all.  Some of them I had adverse effects.  My doctor would perform an endoscopy and inject Botox A into my stomach - I would have some relief for about 6 months before it wore off.  He went in again to repeat the procedure - but my body had built up a tolerance and I didn't respond to the treatment.  A few months later he would try Botox B - but no response.

About a month later I would end up in the hospital for 9 days because I was completely dehydrated and malnourished, because I wasn't able to consume anything without vomiting it back up.  By the time I was admitted to the hospital, I was vomiting blood and bial.  I left the hospital with a picc line, receiving TPN treatment 7 days a week.  That was 2 months ago.  I am still receiving TPN treatment today.  Every day I get up, wash and sterilize my hands, lay out all of my supplies to hook up to my bag for the day (and that is the very abbreviated version of what TPN involves).  Then for 10 hours I carry this bag on my shoulder - which isn't exactly light.

I get up to go to the bathroom - take the bag.

I try to cook my family dinner - take the bag (oh and be careful that the tubing stays away from the hot stove).

Dogs need to go outside - take the bag and be care they don't catch the tubing.

I need to run an errand - take the bag.

Get out to pump gas in the car - take the bag.

At my job I need to pick up what I printed in the copy room - take the bag.

Doing laundry - take the bag.

I am thankful that TPN is keeping me from being hospitalized and instead allows me to be with my family and go to work (something which I struggle with every day, but I am trying to live a 'normal' life so I force myself to go, knowing when my body says 'when' that I have to go home).  But with Gastroparesis I can't live a normal life...

Boss invites me to a lunch meeting - I can't eat, because the menu isn't Gastroparesis friendly and even if it does have something bland, I am usually in too much pain to eat anything.  Nor do I feel comfortable ordering a full blown meal that I will only be able to take a few bites of.

Family is getting together to celebrate - I struggle to be there emotionally, because most celebrations revolve around food and I can't eat like everyone else

My friends want to go out to dinner or out for drinks and dancing - again I can't eat and I don't have the energy to dance

These conditions are life-altering and severely impact a person's quality of life.  I know there are patients which respond to the medications currently available today - however there are so many of us that do not respond or can't take certain medications because of the side effects.

I want to live a normal life.  I don't want my daughter to constantly worry about when mommy is going back in the hospital or worse if I am going to die.  I don't want to hear the worry in my husband's voice or see the concern in my son's eyes, as I lay in a hospital bed.  There are nights I cry myself to sleep because I am terrified of what my future holds, knowing that I have exhausted all of the treatment options my doctor can offer me (he doesn't do the stimulator, nor do I want one based upon the information I have read).  I don't want to shed anymore tears over the patients who have lost their battles to severe cases of these conditions.

I want my life back.

I want my life back.

I want my life back.

Please, make the recommendation for new treatment options - make the recommendation for more funds to be allocated to research (for new treatments and more importantly a cure).

Please help us get our lives back.