This Is MS Multiple Sclerosis Knowledge & Support Community

Get your cyber blue pencils at the ready and have fun! If I don't have to do TOO many re-writes, I (we) might get this out by week's end!

God Bless Us One and All...

My full address
Date
Their full address w/their exciting titles, of course

Dear Dr./Mr./Ms. So-and-So:

My name is Jane ____ (not “the Pain” because this is VERY official, dontcha know?) and I was a patient in the Tovaxin clinical study located in Columbus, Ohio. There’s no practical reason to re-hash Opexa’s reasons for discontinuing this study—that’s an exercise in frustration and gets me absolutely nowhere.

End of story? I’m not ready to concede defeat just yet.

Why, you may ask? If there’s anything that “is” true in today’s technical world, it’s the fact that the Internet has changed the range and scope of available information to the public—especially for a group of people I fondly refer to as the Tovaxin Lab Rats.

Are we a support group from one study site? No, indeed. We’re a support group from ALL over the country, and this is where we come together and do business:

http://www.thisisms.com/forum-36.html

Now while I’m certain we have a lot of “drive-by” readers, we don’t have a quorum of the Phase II Tovaxin-ites by any stretch of the imagination. By and large, these few of us are active and talkative but I’m sure a lot of study subjects have no idea where we are and what we’ve been discussing the last few years.

I… we… would love to hear/read from other study subjects. And from all the physicians, nurses, nurse practitioners—anyone, everyone, who has been involved in this study—for better or for worse.

Because of privacy issues, it would be inappropriate for me to ask you for patient contact information.

But I would like to request that you pass along this information to your study subjects and to site personnel in your practice. And here’s why:

Because TERMS has been reported (with devastating consequences) to the neurological community with mind-boggling statistics and number crunching, it seems as though no one was interested in asking for information from the patients—that anecdotal evidence that makes up the other side of the story.

And I haven’t read any information yet from the (most often) sympathetic and enthusiastic professional medical community such as yourself. We couldn’t have done what we did without you. Your experiences with us and Tovaxin are very important to us, if we have a hope of getting it back.

So will you pass along this information (and my contact info) to your study subjects, please? I/we (the other “usual suspects”) hope to put together some information of our own and present a finished product to large pharmaceuticals already involved in MS research.

Do we need pointers and advice? Absolutely! Please consider this your engraved invitation to join us!

I look forward to reading from your study subjects and from all the rest of the personnel involved from your practice. With a lot of organization and patience, we might just be able to get Tovaxin back on track under another pharmaceutical aegis and roll this parade into Phase III without losing too much time.

Many thanks for your time.

Most sincerely,

(I promise not to sign these e-mails and snail mails “Jane the Pain”).

I am going to run this by some of my friends in the legislature and see if there is something that can be done on a higher level.

I am on the Government Relations Committee for the National MS Society and one of the things I do is seek funds for MS Research. I put together groups who are seeking funds and people who write grants and groups who are doing research. We are doing one right now in Boise.

It seems to me that with all the funds that were earmarked for MS Research in the last budget that some of those funds could have been used/released for this purpose.

Just my two cents...

Happy Holidays everyone!

av8rgirl wrote:I am going to run this by some of my friends in the legislature and see if there is something that can be done on a higher level.

I am on the Government Relations Committee for the National MS Society and one of the things I do is seek funds for MS Research. I put together groups who are seeking funds and people who write grants and groups who are doing research. We are doing one right now in Boise.

It seems to me that with all the funds that were earmarked for MS Research in the last budget that some of those funds could have been used/released for this purpose.

Just my two cents...

Happy Holidays everyone!

Hope you're well and sassy after the big day(s)!
Now then... do you want me to hold off on that little epistle or shall we stick TWO irons in the fire?

..

Lyon wrote:

av8rgirl wrote:It seems to me that with all the funds that were earmarked for MS Research in the last budget that some of those funds could have been used/released for this purpose.

Again, I'd have to think that because MS continues to be considered a T cell mediated disease and that the Tovaxin process is reputed to have identified and removed at least some/most of the T cells responsible for MS, THAT is too important of information to fade into obscurity with a small company which could no longer survive a failing economy.

Personally I think the essential first step would be for a bigwig from the NMSS to talk to a bigwig of Opexa to see if Opexa is even open to outside help.

Bob

NMSS has nothing to do with the funds. It would be up to CDRMP or NIH to release the funds. Opexa would most likely have to write a grant requesting the funds.

One has to wonder how far back the trial would have to go even with additional funding. Back to 11b, 11, 1, etc. I don't think it is realistic to assume, even in the best case that Tovaxin would continue anywhere near where it left off.
Lars

Lars wrote:One has to wonder how far back the trial would have to go even with additional funding. Back to 11b, 11, 1, etc. I don't think it is realistic to assume, even in the best case that Tovaxin would continue anywhere near where it left off.
Lars

That would probably depend on the testimony of administering neuros. I know that mine was a big cheerleader. I/we should know very shortly about the rest!

JanethePain wrote:

Lars wrote:One has to wonder how far back the trial would have to go even with additional funding. Back to 11b, 11, 1, etc. I don't think it is realistic to assume, even in the best case that Tovaxin would continue anywhere near where it left off.
Lars

That would probably depend on the testimony of administering neuros. I know that mine was a big cheerleader. I/we should know very shortly about the rest!

The Public Policy Conference for Multiple Sclerosis is March 9-12 in Washington DC. We are gearing up now to head to Washington and hit our legislators with the issues. Believe me, I am bringing this one up to our committee. I am the Government Relations Chair for the State of Idaho and I am not known for my shyness. Ask Jane...she already knows.

What is the Public Policy for MS? Is there a web link somewhere with an agenda?

patientx wrote:What is the Public Policy for MS? Is there a web link somewhere with an agenda?

This is the link for last year's PPC. This year the dates are March 10-12. Check with your local National MS Office or check the NMSS.org website for the update. We are just starting to gear up for the Public Policy Conference for this year.

http://www.nationalmssociety.org/get-in ... index.aspx

Every year we go to Capitol Hill and talk to our legislators about health issues relating to MS. We focus on bills and legislation directly relating to MS. Last year we focused on getting $15M earmarked for MS Research.

* Secured a new avenue of MS research funding for the first time ever, through the Department of Defense.
* Revised a potentially damaging Medicare policy on coverage of power mobility devices.
* Formed the first Congressional Multiple Sclerosis Caucus in the Senate and the House of Representatives. Find out if your legislators have joined.
* Led more than 100,000 people nationwide to sign the petition to increase federal funding for MS research.
* Helped pass stem cell legislation in bipartisan fashion in both chambers of Congress. View the Society’s position on stem cell research
* Formally established and protected funding for the Department of Veterans Affairs’ MS Centers of Excellence.

Thanks. I'll read up on this.

I recieved a copy of this letter from my study coordinator today.

I was diagnosed 3 years ago this summer and jumped on the tovaxon band wagon as soon as I could. I made it through my first year of the study with flying colors. If you call over coming fears of small spaces and needles an easy feat. I enjoyed having NO site reactions, feeling awake, alert, and like a "normal" person.

I was told that I did receive the vaccine and was to be moved into the open label portion of the study. For 6 months my MRTC count was negative. Unfortunately, my MRTC count was positive in September of '08 and my blood draw did not occur until mid November. I was told to thank a hurricane for the delay. Then one week after the procurement I received a phone call that the study was dropped.

I was told nothing of this before the procurement and I drove 80 miles out of the way to have this blood drawn.

February 7th I started Copaxone and by February 23rd I was off due to interesting and adverse reactions. I was on antibiotics for cellulitis and I still have bruises the injection welts left me.

I hope this short story helps you in any way

RS-Girl wrote:I recieved a copy of this letter from my study coordinator today.

Yessss! It's good to know all my effort and postage wasn't wasted!

RS-Girl wrote: I was diagnosed 3 years ago this summer and jumped on the tovaxon band wagon as soon as I could. I made it through my first year of the study with flying colors.

Huzzah! I note that you seem to fit our profile very well: jumping on the Big T bandwagon... I'm sure with much "gentle" nudging of your neuro... heeheeeheee. We ARE a proactive bunch, to put it mildly.

RS-Girl wrote: ... If you call over coming fears of small spaces and needles an easy feat.

I'm with you on that one. Until I got started with this study, I'd been able to look pitiful and slightly tearful when I requested (read: begged and sobbed) MRIs done with those open ones. People who don't have problems with enclosed space have NO idea what a horror a simple MRI can be... done monthly, in our case, for the first leg of the big adventure.

And needles??!!? Each and every time I had to hit myself with the Avonex was about <---> that close to a complete nervous breakdown. The only thing that kept me sane during the study was knowing I had a super dooper nurse practitioner doing the injecting--so I didn't have to endure nightmares of screwing it up.

RS-Girl wrote: I enjoyed having NO site reactions, feeling awake, alert, and like a "normal" person.

Me, too, me, too! Although I never experienced those flu-like symptoms with my Avonex, a lot of people did/do, and the idea of getting an MS treatment that allows you to get on with your day and get on WELL... it's just amazing.

RS-Girl wrote: I was told that I did receive the vaccine and was to be moved into the open label portion of the study. For 6 months my MRTC count was negative. Unfortunately, my MRTC count was positive in September of '08 and my blood draw did not occur until mid November. I was told to thank a hurricane for the delay. Then one week after the procurement I received a phone call that the study was dropped.

... and some of us NEVER got the phone call...

RS-Girl wrote: ... February 7th I started Copaxone and by February 23rd I was off due to interesting and adverse reactions. I was on antibiotics for cellulitis and I still have bruises the injection welts left me.
I hope this short story helps you in any way

You're doing GREAT making your VERY excellent points!
I'm going to use Monday as my target date for getting MY letters in the mail--feel free to snip whatever you want from my stuff--I've always liked mix and match!
I am relying on Southern etiquette and a sense of propriety to "encourage" a response for all of us from our three point people at Opexa.
Or my next idea might involve taking out a classified in a few newspapers and medical journals to see if THAT would get some attention.

I am also one of those few people who had an adverse reaction to copaxone RS-Girl. Not quite as bad as you, but I suffered from severe debilitating fatigue for over 3 months. It was so bad that I could not even get out of bed. I kept telling my neuro it was the Copaxone. I finally just stopped it and within 5 days, the fatigue was back to my "normal" level of fatigue.

It's now off the list of DMT's that I can take.