Snag #1 or 1,000,000

For those of you who know me well, you know my luck. And it ain't good.

When I left Duke Wednesday they all had these great smiles on their faces as they told me "everything is done and ready, now just sit back and wait and the study will begin". I left thinking "oh, you rookies, you have no idea who you are dealing with". The luck of the Irish got left in Ireland in my case. Here is snag #1 or 1,000,000 depending on when you joined my little life changing saga here.


The checklist to qualify for this study is say... 100 points long. All of these factors have to be validated to qualify, any one of them is off any your ass is out. Well the last blood test I did on Wednesday came back. One of the items they checked is the INR level of my blood. It is a viscosity test to see how quickly your blood clots.

I got a call from Emily, the clinical study paper work coordinator at Duke at about 5:15 today. The study drug contract has a stipulation at about point 98 of 100 that you have to a lower than 1.3 INR. Well guess what mine was! 1.3 So if the study was written as equal to or lower than a 1.3, I would be fine. But since it says less than 1.3 I am out on my ass.

Novartis will not compromise. Emily from Duke spent the better part of the day Friday on the phone and emailing various entities at Novartis to get them to allow a 1.3, they would not. She did get them to allow us to try that single test parameter again though.

Oh and it just gets better and better. This is one of those things that cannot be done anywhere except Duke for the formality of paper works sake. So I have to drive all the way there just to get one vial of blood taken and leave. 12 hours round trip. The kicker is that they have to send it off to an outside lab that collects the blood test from all the patients in the study nationwide. So it is not as if they are going to be the ones to analyse it, they just have to be the ones to pull it out of my arm. What does it matter who mails in the friggin blood???? Why cant it come from Alaska? But that is the rule, so I have to make a special trip just to retry this blood test.

Emily also tried to get Novartis to at least reimburse me for mileage or parking or something because of this special case having to drive 12 hours for 5 mins in the lab. But they were not going for it. Those cheap bastards. Do they not know that I am helping them also with this whole thing. The love is certainly a one way street with them. I am doing all the suffering and they are going to make the millions when this goes to market.

Well we already had an appointment scheduled for Wednesday to try to start the drug if all was approved by Novartis. But since that is not going to happen we would now use that appointment to do the blood test, we don't have to see the Dr. now or anything else but take blood.

So I would have had to miss Tuesday and Wednesday from work. So I asked her if it mattered what day we came now since it is just going to be a lab visit? She said that it did not, and I asked if we could do it Monday so then we could go up on Sunday and only miss one day of work instead of 2. They did not have a problem with that, just that I have to get myself within acceptable limits by then. So that is the plan to get there Monday for the new blood draw, hopefully pass the test and go back Tuesday and Wednesday of the following week (the 22nd and 23rd) to start the drug.

I asked what can I do to bring myself into acceptable limits for this parameter. They told me vitamin K was the target. So I have to eat mega doses of spinach to cram for my test on Monday morning. Also Kale and Brussel Sprouts are high in vitamin K. No wonder I have a bad level on this. What a repulsive group of food has vitamin K in it. Yuck!So my weekend will be spent stuffing down green leafy sour smelling vegetables so I can pass this stupid test.

I then asked of they would be retesting any of the other parameters with this blood draw because the high doses of vitamin K might kick off some other problem and make point 88 for instance out of whack. They said they would only be testing for this INR level and that nothing else would be looked at because I had already qualified in the green for the other parameters. That is good news, I at least have something I can focus on.

This is my last chance to get in. If I don't pass the test level and start the drug by the 23rd. my last CT exam will be too stale to qualify for a baseline. I will have to get another triphasic 3 section CT. All at my cost (about $5,000 total). Or scrap the study drug and go back to MUSC and some other treatment. The clock is ticking and the pressure is on. Wish me luck.
Oh, and did I mention I hate spinach!!!!!!!!!!!!!!