Termination Appt. and What Did You Switch To

Loobie · Post by **Loobie** » Mon Jan 05, 2009 3:39 am

It could also be that this stuff has to be taken intravenously and we all couldn't come in to the clinic that often. I could be wrong about that. I guess I'm making the huge assumption that there aren't any self administered intraveneous shots? Do you know if that's correct? But you are right. Shots every day, or even everyweek get old when it's potentially the rest of your life.

Lyon · Post by **Lyon** » Mon Jan 05, 2009 6:03 am

CureOrBust · Post by **CureOrBust** » Mon Jan 05, 2009 2:32 pm

I don't know much on tysabri, but doctors are well versed in in the results/differences between SC/IM/IV. Also, most dosing of medications are related to the half life of the medication, not simply random guesses or trial and error.

patrickm · Post by **patrickm** » Tue Jan 06, 2009 12:23 am

Hi gang. It's been a while and I really should be in bed, so I'll be short and to the point...for the very first time in my life.

Saw my doc a few weeks ago. Said that I wasn't eligible for most trials as I'd been on Tovaxin AND I haven't had a relapse in the last year. At that time, Campath was out. He said he would be shocked if we were let into any disease modifying trials as nobody knows how and how long the vaccine is effective, so it could skew any results one way or the other, or at least allow that to be posited.

None of the CRABS seems that awesome, and I'm doing relatively OK, so I'm in a holding pattern until March, and we agreed I'd get a new MRI sometime before the middle of the year.

The Campath thing is interesting news. I will run it by him again, but I haven't had the requisite 12 month relapse so I think that's out for me anyway. He did say that sometimes a lit up MRI can pass for a relapse even if there are no symptoms. Right now, I'd say I'm happy without the symptoms or the SBD lesions.

The "oral tysabri" was brought up as well. He said that the IV version of the drug is exceedingly powerful so that it will be effective until the next infusion. So if they find an indicator of the infection, they can't turn the thing off. With the oral meds, it is out of the system in a matter of a few days and the infection is immediately treatable. At least that's what I heard him say. He obviously gave a better explanation than this. I do remember him saying that we all have those infectious agents in our body from when we were very young and for some reason Tysabri activates them some of the time. And something about sticky veins...

OK. Hang in folks. I'm still checking in when I can but mostly I'm busy as hell at work and brain challenged, which makes for long days trying to figure out WTF I'm supposed to be doing and why I did some of the things I have done.
p

av8rgirl · Post by **av8rgirl** » Thu Jan 08, 2009 8:21 pm

I've had some interesting developments the past couple of months. Nov 19th I had a complete spine MRI and it showed no pathology for MS but it showed a couple of pinched nerves and some other stuff. I was dx'd with cervical radiculopathy. Basically I have been having serious problems with my right arm not moving and some serious pain and numb thumb and forefinger, lower arm. I also have some pain under my arm and shoulder blade.

Issue number two, at the same time I was having an exacerbation that the clinical trial doc would not treat. Since the trial terminated, my neuro treated it with 3 days of IVSM. The IVSM actually made my arm worse which confirmed the cervical radiculopathy.

Next, we tried to get copies of my MRIs or any information from clinical trial. Nothing. Proprietary information. I begged for it and finally got a written report last week from my LAST MRI which stated "no changes."

Well...not true. I had a brain MRI Tuesday. It was compared to my last brain MRI in 2006. I have several new lesions in the parietal lobe.

Why would the clinical trial doc withhold this information from me and my neurologist? What purpose does it serve?

They've controlled and controlled, I've played the game, followed all the rules, and then this? Do I know feel compelled to help them find funding to continue the trial? I am more than a little miffed at this latest development. I am not sure exactly what to do.

Now I am wondering if my MRTCs test were negative or positive all those months....makes one wonder....

patrickm · Post by **patrickm** » Thu Jan 08, 2009 9:19 pm

Wow.
All I can say is I need time to process all this, and mostly I am VERY shocked and sorry!

That sucks.

Since they paid for the MRIs, I guess it's not out of the question that they would own those. Not sure what a copy would cost though. Seems like if we paid for the dupe, what harm would it do?

As for withholding the info on your lesions, I am baffled.

As for helping them with funding, well, I would say that perhaps that was not the way to have been looking at it even from the beginning. If you believe in this treatment, it would seem to be more be about helping yourself and others with MS, not the dorks at Opexa or your trial doctor's office.

But being very, very, very angry, angry enough not to do it, yeah. Um, yeah. Yep. I can see that. Might change in a little time, but right now I'd be hopping mad and probably pretty f'ing depressed.

And again, I am sorry.

p

patrickm · Post by **patrickm** » Thu Jan 08, 2009 11:21 pm

Maybe you could use the MRI as evidence in a lawsuit. That would be a reason not to give you copies of it. I'll bet a subpoena would get them though.
Stray late night thought.

Lyon · Post by **Lyon** » Fri Jan 09, 2009 6:12 am

JanethePain · Post by **JanethePain** » Fri Jan 09, 2009 7:18 am

av8rgirl wrote: I've had some interesting developments the past couple of months. Nov 19th I had a complete spine MRI and it showed no pathology for MS but it showed a couple of pinched nerves and some other stuff. I was dx'd with cervical radiculopathy. Basically I have been having serious problems with my right arm not moving and some serious pain and numb thumb and forefinger, lower arm. I also have some pain under my arm and shoulder blade.

Does this mean you're going to have surgery in the near future to zap this pain--once and for all?

av8rgirl wrote: Issue number two, at the same time I was having an exacerbation that the clinical trial doc would not treat. Since the trial terminated, my neuro treated it with 3 days of IVSM. The IVSM actually made my arm worse which confirmed the cervical radiculopathy.

I sure do hate it, Cheryl, that you've had to endure some very serious pain during the course of the trial. If memory serves me correctly--and I'm not betting on it, mind you--didn't the protocol allow a round or three of IVSM? Of course, you'd not have seen "relief" from that pain at all--but making sure you got what you needed seems like a litmus test for "compassion" on the part of the trial docs--and your gang seems woefully short on this item.

av8rgirl wrote: Next, we tried to get copies of my MRIs or any information from clinical trial. Nothing. Proprietary information. I begged for it and finally got a written report last week from my LAST MRI which stated "no changes."

So much for getting "the scoop" when all is said and done! At my last exam (which I didn't know was my last exam--I still haven't gotten THE phone call, by the way...), my neuro was more than happy to round up my MRIs and compare them on the screen.
I guess it comes down to how much a clinical staff is willing to do--besides take the little checkie from Opexa for their participation--I once gawked at the sign-in sheet and learned that Opexa paid $246 for each of my office visits.
I'm willing to bet some of us had longer and better office visits than others... another item that should be addressed sometime.

av8rgirl wrote: Well...not true. I had a brain MRI Tuesday. It was compared to my last brain MRI in 2006. I have several new lesions in the parietal lobe. Why would the clinical trial doc withhold this information from me and my neurologist?

... I didn't think they were supposed to; in fact, it seems to me that ethical practice would have involved informing you right away so that YOU could make a choice to withdraw from the program or continue. Your choice. Informed 100% and no exceptions to that. I don't see how that would have compromised the "un-blindedness" of the program, either.

"What we have hyah is a fail-yah to communicate."

av8rgirl wrote: ... They've controlled and controlled, I've played the game, followed all the rules, and then this? Do I know feel compelled to help them find funding to continue the trial? I am more than a little miffed at this latest development. I am not sure exactly what to do.

Now I am wondering if my MRTCs test were negative or positive all those months....makes one wonder....

I can sure understand why! Surely the established protocol for clinical trial isn't this loosey-goosey. But the really frightening issue is how far up this food chain do these slipshod unprofessional behaviors go?

HEC · Post by **HEC** » Sun Jan 11, 2009 6:28 pm

I had one new lesion on my last MRI in December after the trial was shut down compared to my December 2007 MRI that was done just for me. I was disappointed and wondered why the folks at Opexa didn't say anything, but then it occurred to me that the MRIs I've had done just for me in 2007 and 2008 were both on 3T machines instead of the 1.5T used in the trial. It could be that the 1.5T just didn't pick it up or they didn't consider it significant enough to report. I can swallow the former, but not the latter.

av8rgirl · Post by **av8rgirl** » Sun Jan 11, 2009 6:30 pm

patrickm wrote:Maybe you could use the MRI as evidence in a lawsuit. That would be a reason not to give you copies of it. I'll bet a subpoena would get them though.
Stray late night thought.

Surely you jest Patrick!

I am not mad enough at the people who have participated in the trial to stop fighting for what I truly believe in. Right now, I don't know where the truth lies...ha! That's a good play on words!

I haven't had time to reconcile all of this new information in my brain yet. Maybe it's because I have all these new holes! It's leaking like a sieve!

What I need right now is answers and I don't seem to be getting any. I am hoping that the clinical trial doc is not withholding, that he truly didn't know. (Anyone want to buy some really cheap land near the I-5 corridor north of Portland????)

I hope to SEE my MRI this week, right now I only have the report. We are trying to solve the "my shoulder hurts like hell" issue and it's a priority at the moment. The lesion count was a surprise. Merry Christmas to me.

Here's how disorganized they are: Monday I received a phone call from the site coordinator confirming my MRTC follow up appt for Tuesday. I told her that she was mistaken since the trial had been terminated last November. She said she would check into it and call me back. I received an email from the other person at the site confirming an "oops" and sorry for the confusion!

I am 450 miles away from the site. It takes me 8 hours to drive over there (one way) or a $300 round trip airline ticket. I've not been reimbursed one dime for any of my expenses. As I am sure is the case for everyone. Someone has to know that the trial was terminated?

It always baffles me why the "sick" patient is the one who has to keep track of and keep straight all the meds, appts, records, etc! Who has MS? Oh yeah...I do. I remembered that the trial was terminated and therefore I don't have any more appts. LOL! I didn't need to check with anyone! Idiots!

Back to the issue at hand. Yes, I would love to have copies of my records for the simple reason THAT I DON'T TRUST THEM.

ssmme · Post by **ssmme** » Mon Jan 12, 2009 9:52 am

It's official. I signed on the dotted line today to become a lab rat for Alemtuzamab. I go back next Friday for my screening visit and will then await the final verdict of whether I'll get Rebif or drug. It's an 80% chance that I'll get it so I'm hoping the odds are with me. From here on out (unless I don't get accepted into the trial) I'll be posting on that thread.

Bon voyage Tovaxin...Hello campath.

Lars · Post by **Lars** » Mon Jan 12, 2009 10:25 am

Well, I have heard the 80%/20% Campath/Rebif numbers here more than a few times but is that definitely, positively Campath protocol? The reason I ask is that the trial coordinator at the site nearest me (Albuquerque, N.M.) told me 66/33. I suppose that given the amazingly different site deviations we all experienced during the Tovaxin trial this shouldn't come as a big surprise but really, c'mon!
Lars

Edit: Does anyone know a path that leads further up the food chain at Genzyme? My "potential" new site coordinator seems, at best, hesitant to believe we Tovaxinites have been allowed to participate. At worst, she doesn't return my calls. This seems to be starting out on shaky ground.

2nd Edit: I just spoke to a someone at Genzyme and I quote (to the best of my ability) "The principle investigator at each site has the final word on inclusion/exclusion criteria". And to reiterate my original sentiment, C'MON!

Lyon · Post by **Lyon** » Mon Jan 12, 2009 1:04 pm