This Is MS Multiple Sclerosis Knowledge & Support Community

Well they finally got the damn blood out of me! I did get clarification on the one day delay. The nurse at the blood center didn't even open up the LabConnect box until the morning of. There is a refrigerant pack that they need to freeze for the three test tubes they pull over and above the bag. Anyway, she didn't do it and I had to wait a day. I slightly overreacted but now it is done. 69 days away! I did get slightly irritated when she told me their freezer is 30 degrees below zero. It would have frozen that ice bag solid in an hour and she pulled the trigger to reschedule 4 hours prior. Anyway it's water under the bridge now. Sweety, don't sweat it. Bob is right, I've been called much worse than a female! It was probably when me and Lars were posting in lithp!

I am mentally settled down quite a bit since my bag is now on the way to Texas, but my MS is in overdrive.

I think I have to agree with Bob that the Tovaxin route is the route of choice right now. The MBP 8929 (#'s?) really sounds intriguing, but I was unaware of that when I got in. Plus I was not considered SP by my neuro. until recently, so I wouldn't have been eligible anyway. But I do think Tovaxin, in theory, sounds like the best plan. I mean the MRTC's are what's eating our myelin and this stuff is supposed to make them benign, so...I guess I don't have a follow up to that.

I know this is a huge take from the meat of my post, but everything that is getting worse is all from the waist down and my eyes. This has made my Dr. want to do the Mayo clinic Devic's test. If you remember when I first joined this forum, it was because I had just been "re-diagnosed" with MS from a diagnosis of Devic's. He says he's doing it to be exclusionary since Devic's is pretty rare and I guess it's also always RR; but apparently the relapses can really put you down. There are also usually no, or maybe a few, brain lesions with Devic's. The appearance of seven lesions in my brain is what made my doc. change back to MS. Prior to that, I only had lesions (that they saw anyway) on my spine. Oh well, wish my bag-o-blood luck!

Sweety and Bob,
I guess I was under the assumption that they would time the extension procurement so that open label injections would be ready at the end of the trial year. It only makes sense to me that the every month schedule would continue. I can't imagine that giving a bag of blood 12 weeks before the year end could possibly do any harm to data gathering. I'm going to need another Doctor before this is over, Psychiatrist I think. This news takes me to about next September. I wrote about wishing my life away a few posts back, here we go again.
Chasing a Dream,
Lars
PS As I posted I saw your new post Lew, congratulations.

Thanks Lars,

I never noticed the Colorado in your heading until you mentioned skiing. I love your state. Our family vacations in the winter were always somewhere to ski. Vail, Telluride, Copper, Keystone. I've done all of them but Aspen and Snowmass. I do miss skiing. However, it was the eyes that kept me from doing that. We went to 7 Springs in PA shortly after I was diagnosed. I had the legs and the energy, but the ON made the light "flat" and I couldn't see the bumps and stuff when going down the hill. Meeting bumps when you don't know they are coming on a black diamond (black in PA, blue out west!) is not an experience I want to have again! I've gotten over the skiing because it was so long ago that I stopped. I would love to ski again and still have not gotten rid of all my gear. I hope your disease course takes a good positive turn. This trial is such a mind f. if you are progressing because of the hope we all have that this is going to work for us. I'm pulling for you brother.

Lobbie,
If your ever in the neighborhood........... I didn't see Silverton Mtn. on your list.
Lars

Lars wrote:Sweety and Bob,
I guess I was under the assumption that they would time the extension procurement so that open label injections would be ready at the end of the trial year. It only makes sense to me that the every month schedule would continue. I can't imagine that giving a bag of blood 12 weeks before the year end could possibly do any harm to data gathering. I'm going to need another Doctor before this is over, Psychiatrist I think. This news takes me to about next September. I wrote about wishing my life away a few posts back, here we go again.
Chasing a Dream,
Lars
PS As I posted I saw your new post Lew, congratulations.

Hi, y'all--and here I am, LATE, as usual! But I wanted to comment on this timing factor, since I'm up for the trek to Columbus next week (although with MUCH bitching and arm-twisting, I got a later appointment so I don't have to be driving in the winter dark).

I completely agree that this protocol should be ready for us to get "the real thing" on Day # 366--or 367, since this is Leap Year.

After all, I've been "contributing" 15+ vials of blood every visit (excluding the BIG draw), and was told this was to "feed the cell lines." Don't know about your-all's lines, but I sort of imagine mine as bordering on the "obese" with all the feeding they've been getting--surely enough to culture out a timely dose of gunk for Day 367.

And I'm hardly amused that I may have to wait for "the real thing" as long as I had to wait for Dose # 1--I seem to remember that I was 94 days between the big blood-letting and that first jab. A similar timeline could delay me to about Labor Day. Not amused. In the slightest.

Of course I'm not about to bail at this point.

At the least, we deserve reasons "why" so many protocol points seem so illogical. Whatch'all think?

69 days was the magic number I was told.

69 is not all that magical. it's not what its cracked up to be!
-sorry! couldn't resist

Hiya, Jane!
yeah i was disapointed also.
I was under the assumption that all those vials throughout the study was for tests. I never considered that they could use that blood for anything other.

Is it quite possible that once things start moving along more smoothly that the rest of you guys wont have to wait as long?
My point is the study is semi new and getting protocols in place may be what has put us in a delay. Or maybe that was the plan all along. I haven't a clue really. Just pondering.

Sweetyhide wrote:69 is not all that magical. it's not what its cracked up to be!
-sorry! couldn't resist

Hiya, Jane!
yeah i was disapointed also.
I was under the assumption that all those vials throughout the study was for tests. I never considered that they could use that blood for anything other.

Is it quite possible that once things start moving along more smoothly that the rest of you guys wont have to wait as long?
My point is the study is semi new and getting protocols in place may be what has put us in a delay. Or maybe that was the plan all along. I haven't a clue really. Just pondering.

I just think we should let your avatar do the "reasoning" for us when things get really messy. How 'bout that?

Lew,
69.... really, I can picture your clinical staff still laughing.
Lars

.

Bob,
It really makes me crazy when someone makes a point that I cannot argue. Your post made be realize that I have been a bit selfish and forgetful about my original intentions when I signed up. It seemed so easy to claim "nobleness to the cause" before my ship went South. I hope we can all appreciate our sacrifice to the science of this trial and to the hope it gives the MS community. If nothing else, we can all be proud of our contribution. Now that I have been forced to acknowledge all of this, I am never talking to you again Bob.

.

I must admit that the primary reason for me was 100% selfish; I had read about Tovaxin and I wanted some. Granted I thought about the altruistic points to participating in this trial once it started, but I got in for me. And then I get that damn placebo (well, I don't absolutely know, but like Lars, my compass has pointed South through this whole thing). I don't know how much I posted about this before, but I do know what I saw when I turned around and the syringe was in the back of my arm for the "30 second hold". Nothing but crystal clear fluid. I know I wasn't supposed to turn around, but I did when I felt the nurse move, and I know the drug is brownish, so I'm convinced I got the sugar pill, but I don't have "documented" proof other than my observation of the color. At this point it doesn't matter anymore since I am less than 69 days by a week or so now (you filthy minded forum participants ) so I hope to coast to the finish line and start burnin' down the house!

.

Bob,

I thought the exact same thing. I discussed this with my research nurse and coordinator at length. I will try and summarize.

At my very first dose I was turning around to look at where he was going to jab me. He told me to please turn around. I did. He then put the shot in me and told me to keep looking forward. It's sub-q, but for some reason they stick you, then leave the syringe in there for a short period of time (30 seconds if I'm not mistaken). Anyway, he told me it was prototcol so we wouldn't see the syringe. I said what for, and he said they don't want you to see the syringe and make judgement based on what you saw. I told him that I didn't know what color it was anyway. My coordinator piped in and said that Opexa was aware of people talking on the internet (probably from trial participant feedback at the different locations) about the color, so I am going to assume that they would have some sort of safeguard for that now.

Well on about my third dose (I don't remember exactly), my nurse was holding it and I "felt" him turn. I'm 5'8" tall and this guy is a house. He has to be 6'5", if not taller. Anyway, he turned around to get something off the counter and I stole a quick glance. They never saw me do it, but I told my coordinator that I saw it but did not know the color of the good stuff. He wouldn't tell me and that's when he told me about the discussions he had with the Med. coord. at Opexa about people talking online.

It sounds like a totally weak control, but remember, the only unblinded person is the nurse who gives the shot; that's it. The Dr. doesn't know, the research coordinator doesn't know, and Opexa doesn't know. They ship both placebo and real drug every time and whichever doesn't get used I imagine gets discarded. To me, they could make opaque syringe covers once the nurse gets the two syringes he/she needs. However, with this being a new substance that no trial participant has seen before, maybe they felt like it was not that big of a deal. After all, all the CRAB's are clear. I don't know about Copaxone, but I've seen the others and they are clear. Maybe they theorize that we are going to draw conclusions about whether we are placebo or not anyway. Then since they are not going to tell you the color of the drug, it would all be seen as speculation anyway.

That's a weak argument, but it was obviously a point of discussion between the medical directors at Opexa and the trial sites since they were all aware of people trying to find out the color of the drug. There really is just no good reason to have it a point of protocol to have the participant not turn their head and look other than they don't want you looking at it. I'll agree with you that that doesn't sound very sophisticated in today's world. It's just my guess, however, and should be treated as such. The next time you are in getting dosed, ask your coordinator why we can't turn around and let me know what he says. I was taken aback that the nurse was the only one that really knew. The reason for that is that me and Jim (my nurse) talk for the whole hour and share a lot of common philosophies politically and what not, and I would think he would be the easiest for me to coerce the knowledge out of. I jokingly asked him how much it would take to find out and he said "what are you going to do with the information anyway?". I conceded good point since he knew I was going to see it through, and here we are!