Having slept on it, I will address the elephant in the room and it's not cute, winky, or funny.
If you are taking actions that skew your data, then you are selfishly ruining the entire purpose of the trial for everyone else.
I don't normally begrudge anyone from doing what they need to do to advance their own health, but in my view you are fucking with all of us, and the prospects of others who are not in the trial, by taking your selfish actions.
I'm rarely surprised at the selfish behavior of others, but after being as conscientious as I have been over the last 20 months, it pisses me off in no small order to read crap like this, ESPECIALLY after reading Opexa's top line data. If you were getting vaccine and also taking something outside protocol that somehow made it ineffective, it skewed the data to show it less promising. If you were getting placebo and took something outside protocol that kept you from relapsing, then that also skewed the data.
As my doctor said, people on placebo and doing poorly are just as important to the study as those on vaccine and doing well. And now if you look at these results, you can clearly see that is true. 1/150 is no small percentage. If you have been reading this forum, you can see the agony of some who have not done well throughout the study, or whose loved ones have not, and they stuck through in the belief that the study was important and that even if they were on placebo, they would be getting vaccine in year two. For me and my family, we had many, many days and nights wondering if I was doing the right thing for myself by jeopardizing my short and long term prospects by enrolling in a study with placebo. We stuck with it because of the promise of year two vaccine AND because we thought it was the most promising prospective treatment on the way up and thus it was important work that needed to be done.
If your selfishness helped in some way to cause these disappointing top line results, then the repercussions are tremendous to the health and well-being of those both in the study, and those outside it who are in terrible need for a working therapy and pinning their hopes on the results of our study, and there are many, MANY of them. Then for good measure throw in the huge financial loss that the company and stockholders took as well, making it less likely that they'll be able to continue with OLTERMS, much less Phase III.
The study also clearly says that you can pull out at any time, which means that if you started the trial and did poorly, you are free to leave and try other options to protect your own health. No one held a gun to your head and made you sign those papers at the beginning of the study. In short, I see no excuse for your actions here, and you have let your own exceedingly selfish goals top the whole reason for the research.
I'll let those with MS outside the study who were hoping to see positive results that may have been skewed by your actions, speak for them selves. But for all of us who followed our protocol to the letter no matter the personal ramifications, my reaction begins with F and end with U.
If you have any scruples, and at this point that seems doubtful, then you'll admit your behavior so that your data can be pulled out of the mix and the results can be rerun properly.