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Pirfenidone trial 20-month follow up

What a week. What is it they say about the best laid plans? This admission at NIH was supposed to be maybe a bit longer than the usual Pirfenidone trial admission, but still pretty simple and routine. And from the perspective of the trial, everything was smooth sailing. It was just all the other things that came up during the week.

First the good news. I still continue to do very well on the lung function front – in fact, once again my PFTs were better than they ever were, even before they fell a bit making me eligible for the trial.

In fact, they are so good that I think Kevin and the gang might be second guessing if they jumped the gun admitting me to the trial in the first place since the pulmonary fibrosis on my CT scan is so very mild. During my wrap up they brought up the fact that some people don’t try hard on the PFTs when they are being screened in hopes of getting into the trial. They didn’t come out and say they thought I did this, but still, I wonder if they wonder. The thing is it’s hard for me to imagine how anyone could fake PFTs in such a way that it wouldn’t be noticed. How would you know exactly how hard to blow, or how much air to suck in that it would put you into the trial yet not be so bad there’d be a major discrepancy between your PFTs and other tests? I’m sure that they are right. I’m sure that there have been people perhaps trying to fake their way into the trial, but I am not one of them. I don’t have enough nerve to try to pull it off. The only thing I did do at the time of my screening was tell myself that the PFT results didn’t matter. Either they would be good and I would be excluded, or they wouldn’t and I’d get the chance to try to do something about it. That was more of an emotional coping technique than a resolve to not try my best.

The other thing is it just isn’t personal. Kevin and Dr. Markello and the rest are scientists. They’re supposed to consider all the scenarios that might impact their data.

As for me – what can I say – I’m just thrilled with my results.

As we add more patients to the protocol and the chances that the interim statistical analysis will happen maybe within the next two years, I am thinking a bit more about whether I want to know if I was on placebo or Pirfenidone when the double blind is finally broken.

On the one hand, I honestly will feel like a bit of a schmuck if it turns out that I made these kinds of gains on the placebo and all the exciting progress was in my head.

But on the other hand, I have this warped personality. I want to know. I want to tell the story, and the story isn’t complete without all the information. My feelings on the subject might be different if my results weren’t so good – so I guess I should stop thinking about this decision until I actually have to make it.

It is part of the “drug trial” experience though. How can one help but look at those white capsules every day and wonder what the heck is in them? It’s a mystery three times a day. Would I be able to stand never knowing the answer?

Okay, more blogging later. I really need to get to bed. Lots more to tell.

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