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In the article, I was impressed to see that some people in the trial had improved and I wanted to see what my neuro would say.
My neuro read the article and then he read more about the way the vaccine works (also included in the article). He said that this was quite dangerous because there is a theoretical possibility that the immune system could not only begin attacking the myelin reactive t-cells but could also start attacking other t-cells. Perhaps in some people, the myelin reactive t-cells could somehow resemble other “normal” t-cells. Then your immune system would start attacking your normal t-cells. He then said that the immune system is quite complex and that many things could theoretically happen with this technique. From what I read, this vaccine has been tested on many people and there has been no safety concern, at least not yet. I don’t think this would be a common problem but is it possible (theoretically speaking) that it could be a rare problem that could take place once a large number of people are exposed to it? Maybe my neuro is wrong?
I would love to hear from Tim about this. I want Tovaxin to be effective and I would join the phase III trial if I can and I pray that this will be the case. I know that no risk free and effective treatment for ms exists.
Joined: May 04, 2006 Posts: 3155 Location: Mid-Michigan
Posted: Wed Jun 25, 2008 7:33 am Post subject: Re: Something my neuro said about Tovaxin
alexisss wrote:
He said that this was quite dangerous because there is a theoretical possibility that the immune system could not only begin attacking the myelin reactive t-cells but could also start attacking other t-cells. Perhaps in some people, the myelin reactive t-cells could somehow resemble other “normal” t-cells.
Hi alexisss,
I also look forward to Tim's response, but in the meantime it does seem that your neuro is worrying inappropriately and basically his worries sound eerily similar to what is already happening in someone with MS and also what "might" be happening with MS regarding "molecular mimicry".
Looking at the odds it seems your neuro's worries are theoretically as likely as hitting the moon with a bottle rocket and in practice those concerns might be considered to have already proven unlikely, but in defense of your neuro, NOT worrying about what might be possible is how people get injured or killed in clinical trials.
alexisss wrote:
I don’t think this would be a common problem but is it possible (theoretically speaking) that it could be a rare problem that could take place once a large number of people are exposed to it? Maybe my neuro is wrong?
Although much effort is taken to reduce that possibility, that is a very real factor in every clinical trial and that's exactly why the FDA continues to monitor drugs even after they've become licensed.
Making needed treatments available in a timely fashion and NOT noticing negative side effects from the treatment 20 years down the road is a delicate balancing act which will never be perfect or risk free without making the clinical trial process last 20 years and withhold treatment from the masses for that long. Whether the public realizes it or not, they accepting that risk until a drug has been available for 40 or 50 years.
Bob _________________ Wife diagnosed with MS in Feb. 2006 and is a participant in the Tovaxin IIb clinical trial.
Joined: Nov 29, 2006 Posts: 67 Location: Versailles, Kentucky
Posted: Thu Jun 26, 2008 1:14 pm Post subject: Re: Something my neuro said about Tovaxin
alexisss wrote:
He said that this was quite dangerous because there is a theoretical possibility that the immune system could not only begin attacking the myelin reactive t-cells but could also start attacking other t-cells.
Take a look at http://www.tv.wallst.net/r/3-minute-press/kazman/113/537 for a short interview with David McWilliams about previously reported Tovaxin data. In this little interview he specifically addresses the safety issues that have been observed with Tovaxin. Lot's of things are theoretically possible but the real story will be borne out in the actual use. So far the results show no safety issues have arisen.
Joined: Jun 14, 2007 Posts: 96 Location: Historical Glendale, OH: Home of the Squirrrels
Posted: Fri Jun 27, 2008 8:29 am Post subject: Re: Something my neuro said about Tovaxin
hmtucker wrote:
alexisss wrote:
He said that this was quite dangerous because there is a theoretical possibility that the immune system could not only begin attacking the myelin reactive t-cells but could also start attacking other t-cells.
Take a look at http://www.tv.wallst.net/r/3-minute-press/kazman/113/537 for a short interview with David McWilliams about previously reported Tovaxin data. In this little interview he specifically addresses the safety issues that have been observed with Tovaxin. Lot's of things are theoretically possible but the real story will be borne out in the actual use. So far the results show no safety issues have arisen.
Mike
I've kept an eye on this thread for awhile and decided it was time for me to weigh in with my jaundiced eye and typical cynicism.
A relationship with a neuro is a special thing, certainly. As patients, we have a lot of responsibility and need to keep cool at all times.
But neuros have a responsibility, too. My experience with Fired Neuro # 1 rings a few bells when I read this case.
When I was first diagnosed, I did a lot of research about treatment options and made the old Avonex decision before I even stepped foot in the neuro's office. This guy wouldn't hear of it; no, no, no, he prescribed Beta Seron for ALL his patients and there was absolutely no negotiation. Fired him. And found out later he had a great financial interest in Beta. Hmmmm...
Neuro # 2 was fine with Avonex--this was a great guy and we worked well together until he left the area. WAAH!
About this time, I started getting info on Tysabri and his replacement and I agreed that as soon as it met FDA approval, I'd be on board. Well, we know how that got delayed! Grrrr. And I was only 24 hours away from the first infusion when THAT happened!
Between this area being seemingly unable to keep great doctors AND my problem with firing others for mischiefs great and small, I tend to have quite a list of past docs! So, a couple of neuros later, it looked like Tysabri was coming back.
Then THAT neuro decided that no, no, no, she wouldn't prescribe Ty under any circumstances. All those PML horror stories PLUS new ones, too. She could definitely have a second career writing B-movie scripts.
So I fired her and spent some time in limbo, doing that "finding a new neuro agreeable to Tysabri AND jumping the insurance hoops."
Then I found Tim's website. And the rest is history.
But while I was jumping the hoops to qualify for this trial, I learned that LAST neuro was a primary researcher on oral interferons. So no wonder she was such a nay-sayer about Tysabri!
Moral of this rant: when you've done tons of research on a therapy and you get hit with a neuro telling you a horror story, you might want to investigate a money trail.
Yip, I'm a jaundiced cynic. No doubt.
I truly believe Tysabri would be dominating the APPROVED therapy market right now if patients had the truth about that PML mess. Let's face it--a lot of people (neuros with vested interests) would lose their shirts if demand for the CRABs suddenly evaporated.
And once our stuff gets the FDA nod, I expect Tysabri to fall off the radar, too.
And to paraphrase Sherlock Holmes, when something fails the logic test, the illogical, no matter how shocking, must be considered.
So when a neuro paints you a scary picture of Tovaxin--when WE logically know there are no reasons for going into pre-hysterical mode--the reason canNOT be a medical one.
As these CitiBank ads say, "What's in his wallet?
I'll get off my soapbox now... _________________ Jane the Pain
Last edited by JanethePain on Sun Jul 06, 2008 9:01 am; edited 1 time in total
We should not look for a neurologist that always agree with us, because we may be wrong. I would like to think that 4 years of college, 4 years of medical school, and 3 years of residency gives the neurologist a little more insight than I have.
I would recommend that people with MS select a neurologist whose primary focus is patients with MS. Otherwise, his/her knowledge base is diluted with stroke patients, Parkinson's Disease, etc. and not exclusively MS. _________________ Best regards, Tim
In 2001, my family helped fund the startup of Opexa. My father served on the Board of Directors of PharmaFrontiers, now Opexa Therapeutics, until the company completed a successful 23-million dollar financing round.
Joined: May 04, 2006 Posts: 3155 Location: Mid-Michigan
Posted: Fri Jun 27, 2008 9:57 am Post subject:
I like the graphic!
Tim wrote:
I would like to think that 4 years of college, 4 years of medical school, and 3 years of residency gives the neurologist a little more insight than I have.
I don't like to disagree with my buddies but I think an equally good/better argument can be made that the biggest handicap neurologists have had in opening their minds/finding the right answers in MS research has been their education.
Generation after generation of researchers/teachers have passed down close minded and incorrect "facts" until we are where we are at today with ZERO conclusive evidence but lots that is suspected...........basically the situation is exactly the same as it's been in each of the other 149 or so years of MS research.
Bob _________________ Wife diagnosed with MS in Feb. 2006 and is a participant in the Tovaxin IIb clinical trial.
I don't like to disagree with my buddies but I think an equally good/better argument can be made that the biggest handicap neurologists have had in opening their minds/finding the right answers in MS research has been their education.
I assume you believe that ontogeny recapitulates phylogeny, which as Herbert Spencer postulated – If there be an order in which the human race has mastered its various kinds of knowledge, there will arise in every child an aptitude to acquire these kinds of knowledge in the same order.... Education is a repetition of civilization.
Most universities will not hire their own PhD recipients. It is like inbreeding, and does not allow the pool of knowledge to expand. In any field, there will be those that stagnate and see no farther than the facts and theories that were drummed into them during their medical training. If anyone feel that their doctor falls into that category, as Jane would do, fire him/her and find one who specializes in MS.
A doctor who specializes in neurology and then sub-specializes in MS, is going to be aware of what is in the pipeline and will not be content to wear the comfortable shoes of a stagnant pool of knowledge that many less motivated doctors find comfort in. _________________ Best regards, Tim
In 2001, my family helped fund the startup of Opexa. My father served on the Board of Directors of PharmaFrontiers, now Opexa Therapeutics, until the company completed a successful 23-million dollar financing round.
Thanks everyone for your answers. Thanks Mike for the link. I enjoyed watching it.
My neuro who said this to me is an ms specialist. He has been treating ms patients exclusively for MANY years (I think he’s in his 50s now). He has also been involved in clinical trials. But, this doesn’t mean that his worries about Tovaxin are justified. I do find him to be pretty conservative however (he always emphasize the potential danger of all treatments I talk about) He wasn’t really familiar with Tovaxin. All he knows is pretty much what he quickly read in the article that I brought at my appointment.
Joined: Sep 12, 2006 Posts: 757 Location: Dayton, Ohio USA
Posted: Sat Jun 28, 2008 7:37 am Post subject:
[
A doctor who specializes in neurology and then sub-specializes in MS, is going to be aware of what is in the pipeline and will not be content to wear the comfortable shoes of a stagnant pool of knowledge that many less motivated doctors find comfort in.[/quote]
That's the rub right there. A neuro. who isn't making his decision on what he already has known for a while is not going to be aware of what's coming. I think all I'm doing is agreeing with everyone, but find a neuro. that does MS trials at his location. They are the ones who stay current. _________________ "When you're in jail, a good friend will be trying to bail you out. A best friend will be in the cell next to you saying, 'Damn, that was fun.'"
Joined: Sep 12, 2006 Posts: 757 Location: Dayton, Ohio USA
Posted: Sat Jun 28, 2008 7:38 am Post subject:
OK,
Today I'm going to figure out the quote box thingy. _________________ "When you're in jail, a good friend will be trying to bail you out. A best friend will be in the cell next to you saying, 'Damn, that was fun.'"
Joined: May 04, 2006 Posts: 3155 Location: Mid-Michigan
Posted: Sat Jun 28, 2008 7:49 pm Post subject:
Loobie wrote:
That's the rub right there. A neuro. who isn't making his decision on what he already has known for a while is not going to be aware of what's coming. I think all I'm doing is agreeing with everyone, but find a neuro. that does MS trials at his location. They are the ones who stay current.
I have a tendency to agree with what you're saying to a higher degree than what Tim said, but you still may be giving too much credit.
Not that I find any pleasure in slamming neuros but I think it's important to state the situation as it really is, and the truth is that I don't remember hearing anyone on this site EVER mentioning that their neuro was already aware of Campath, Tovaxin or Revimmune.
I have zero complaints and I don't question the competance of the neuro in the Michigan Tovaxin IIb clinical trial but at least here the trial coordinator's main job for the hospital is to line up clinical trials (extra cash input) and then line up appropriate trial doctors. At least here it isn't a situation in which the trial doctors necessarily have any specific interest in pursuing clinical trials or that they are outgoingly open minded to new treatment considerations.
Bob _________________ Wife diagnosed with MS in Feb. 2006 and is a participant in the Tovaxin IIb clinical trial.
Joined: Sep 12, 2006 Posts: 757 Location: Dayton, Ohio USA
Posted: Sun Jun 29, 2008 7:42 am Post subject:
I am lucky in that regard. There are not many neurologists in Dayton, but my neuro. speaks at lots of MS Society functions. He was at Harvard when they were first trying Cytoxan in the late 60's. He is fully aware of all the new stuff. Our site is doing the Campath trial where 80% get the Campath and the others get Rebif. He is doing the BioMS MBP trial for Secondary progressive, and is also doling out Rituxan. With Dayton being only about half a million people, I got lucky on the complexity of our MS site. My doctor said he has always been more intrigued with MS than any of the other things. He is also doing one Parkinson's trial, but most of the trials we are doing are for MS. They had a center for Tysabri infusion when it was still called Antegren.
I think it's location also. We had a very large hospital go under about 20 years ago. St. Elizabeth's it was called. Well a group of investors bought it up and it is now about 90% filled and is like a 'medical mall'. There is a heart and vascular hospital on site. A huge imaging center, and there are lots of physical therapy companies in there. It's like a big place for all the "accessories" that are at a hospital. It's pretty cool and I count myself very lucky to have these guys around Dayton. Ohio State has a great MS center, but the one time my Mom talked me into checking it out, they told me I was doing just fine with who I was going to. Apparently he is well known in MS. Maybe I am naive thinking all sites that do trials are like that, but I really love my neuro.. He is totally fine with me going whatever route I want to go, even Revimmune if it comes to that. He recognizes that I've done my homework and will actually ask me if I want to hear his concerns about going a particular route. Concerning Tovaxin, he just gave me the info. and it turns out I was already familiar with it, but he doesn't push stuff on you. He gives you the info. and the opportunity to participate, that, to me, is something to feel good about since I feel if he was beholden to a pharma., he would push one of the drugs more than the others. _________________ "When you're in jail, a good friend will be trying to bail you out. A best friend will be in the cell next to you saying, 'Damn, that was fun.'"
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So, a couple of neuros later, it looked like Tysabri was coming back.
