PRELIMINARY RESULTS FROM TYSABRI INVESTIGATION!

A board to discuss the newly-released drug Tysabri, (formerly known as Antegren) as a treatment for Multiple Sclerosis

PRELIMINARY RESULTS FROM TYSABRI INVESTIGATION!

Postby OddDuck » Mon Jul 25, 2005 7:38 pm

Hot off the presses, folks! Here are the preliminary findings from the investigation into the Tysabri incidents.

This first one pertains to the poor woman who died:

http://content.nejm.org/cgi/reprint/NEJMoa051782v1.pdf

Please read this one (above) carefully. MY question from reading this is: Did this woman even ever have MS at all??? Did the autopsy ever find lesions indicative of MS at all? Her neurological examination and symptom(s) presentation is/was almost exactly like mine a couple of years ago, as a matter of fact. Makes me shiver!!

This second one pertains to the gentleman who did not die:

http://content.nejm.org/cgi/reprint/NEJMoa051847v2.pdf

Apparently, these are due to be published officially on July 28th.

I guess I have to say I have no comment.

:(

Deb

EDIT: I'm a little freaked about that poor woman. No O-bands and no inflammation, and she's taking strong anti-inflammatory and immuno-suppressing medications? Why? And her EDSS scores only ranged from 0 - 2 or so? I was at 2 on the EDSS two years ago. Her chart and history reads too close for comfort to how mine did. Sorry, but reading that one really affected me. Time for me to call it a night!!

Be well, everybody.
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Postby Arron » Mon Jul 25, 2005 11:39 pm

hi Deb,
Very interesting observation regarding the woman who
passed on... if she didn't have MS, it would be a tragedy that she was
undergoing such potent treatment. Also, one wonders how the gentleman
in the Crohn's trial was allowed to undergo yet another
immuno-suppressive therapy when his white blood cell count was already
quite low after years of taking potent immunosuppressants.... In any
case, these articles were actually pre-released on the web a few weeks
ago:
http://www.thisisms.com/modules.php?nam ... mp;sid=221

looking forward to your further analysis!
Disclaimer: Any information you find on this site should not be considered medical advice. All decisions should be made with the consent of your doctor, otherwise you are at your own risk.
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Postby OddDuck » Tue Jul 26, 2005 4:27 am

Thanks, Arron.

Oh.........sorry. I haven't been around here for quite a while, so I've missed quite a bit, I guess. The date on these said July 25th at the bottom, so I thought they were newly released. That's me, though.............a day late and a dollar short! :wink:

I had said one other time a while ago (regarding the combination of drugs clinical trial patients were allowed to take), or I should say "asked", "WHO was this person's head study doctor?" The head study physician (and the patient's regular neuro) also has something to say and has quite a bit of leeway in treating these clinical trial participants while they are in the trial. If I were an attorney, I'd bring in the head study doctors, also, as a defendant in the lawsuit.

Have things gotten a little bit "lax" or what? How many times have we here on thisisms put two and two together and come up with very valid questions, ya know? If I were a physician, I would DEFINITELY say "hold the phone" as soon as I realized someone's white blood cell count was out of range, etc. etc. (Just like you did, Arron.)

God, that's scary!!

And this is pure pondering on my part, of course, but why would any person (like this poor woman) logically submit herself to taking such POTENT medication when she wasn't that bad? WAS she told exactly how potent each drug (Avonex and Tysabri) was ALONE, nevertheless the fact that this was combining the two. Whether it "worked" or not, it was still an extremely potent combo. Tysabri ALONE is a very strong immuno-suppressant. Not saying that is bad at all, but like I mentioned before months ago.............if you do NOT have any inflammation going on, you need to think twice, three, four times before taking any drug that messes with your immune system, nevertheless one that also subjects you to such a large margin of infection.

You know, immunosuppressants like Tysabri and Novantrone will not only possibly sway your body to be much more susceptible for having the JC virus get out of control, but definitely also leaves a person open for ANY infection to get out of control. Let's not forget that part.

Now, that's "ok" (if that's the word to use), IF a person knows that up front before they take the drug. And I don't mean just throwing percentages at someone, either. Open to infection means open to infection. ANY infection that your body would normally be able to resist or keep in check. And some infections (and we have many laying dormant in our systems, not just JC) are nasty devils, not to mention the contagious ones we might pick up just travelling around town!

Here's a comment from a medical expert (isn't this one of the men involved in the investigation above?) who says:

...."In the patients who received natalizumab and also had other medications such as Avonex, it's likely that the prevention of normal migration of the lymphocytes in the tissue allows the virus to replicate without being contained, and finds its way to the brain and causes the disease," said Dr. Kralnick, who co-authored an editorial accompanying the NEJM case reports.

"It is also not entirely ruled out that some people have the virus latent in the brain and in certain circumstances need to have the trafficking of lymphocytes to prevent the virus from reactivating within the brain." ....


I had posed this back in November about Tysabri:

...."The other possible problem, though, is the fact that it doesn't allow ANY T-cells to cross. Hence why it says that over time, the body switches to a mainly TH1 immune response. In MS, you want to keep your immune system predominantly TH2. Plus, this allows a HUGE margin for infection, etc. to run rampant should you ever pick something up.

My question also then is...........you DO want the "good" interleukines to do its work in MS (i.e. such as IL10, and other anti-inflammatory cytokines), so if you take Antegren as a monotherapy, how long WILL it take before it stops working? And especially since Antegren only works via ONE mechanism of action, where are the balancing mechanisms that you need to balance out what it's doing?" ....


Gee, was my concern valid, even back then? Even using Tysabri as a monotherapy. Are we CERTAIN that even using Tysabri as monotherapy might not eventually still result in the same risk? Take Novantrone for example. There is a limited amount of time you can even take it.

I wrote to the NMSS and my first neuro asking that same question above, and I couldn't get any medical "expert" back then to answer me. That frustrates me. How COULD any clinical trial patient be fully "informed" in order to give fully informed consent when their questions aren't even answered when asked?

I will never forget the answer I received when I was about to participate in a clinical trial comparing Copaxone with Betaseron with DOUBLE dose Betaseron. My question to my neuro/head study doc was: WHY are they testing a DOUBLE dose of Betaseron? The answer I got was not medical at all. The answer I got was this: "Well, it's just like chemotherapy. If a little is good, then more is better." How stupid is that for an answer? In other words, they are clearly simply working totally blind and possibly subjecting patients to extreme risk without providing enough information.

And the burden of being fully informed does NOT lie with the patient. It is on the side of the study sponsor and head study doctor. It is up to them (by law) to FULLY inform a patient of any and ALL possible risks. If I knew the possible risks, someone else MUST have! But no patient should have to dig for the information like I had to last November.

What an unfortunate nightmare!

Deb
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Postby OddDuck » Tue Jul 26, 2005 4:47 am

I will say one more thing.............Vanderbilt would never have diagnosed that woman who passed on with MS. And it has to make you stop and re-evaluate the Mayo's recent (last year, I think) recommendation to NOT start taking injectable medications for MS right away anymore.

Ok..............to throw myself back in the mix again, then. My presentation of neuro disease (or whatever it is) was almost exactly the same as the woman who passed. IS that MS? Or something else unknown? IS it a demyelinating disease or something unknown? Is something like Fibro (which is NOT a demyelinating disease) more of a neurological disease and capable of causing more permanent disability than originally thought?

If I have Fibro, then the answer to the above questions regarding Fibro is "yes". And would treatments for MS work for Fibro? No. I'm telling you, Fibro causes ALL of the same symptoms as MS, PLUS some extra ones!

And if something like Fibro DEFINITELY does NOT result in permanent damage, then how DID I receive the permanent damage I have? Etc. Etc.

I said before and I say again. There are many (especially women) out there diagnosed with MS, who present with the same symptoms and neuro results as this woman who passed and I do, who are diagnosed with MS and/or Fibro (sometimes both), BUT are never really clinically researched. I still say we, as a separate group, with atypical MS type of symptoms and disability should be STUDIED MUCH further!!!

Oh, well.............for all THAT statement will get me. When I tried to get my physicians to study me farther, they refused. It wasn't "ego" or an attention-seeking request, it was out of concern for others.

Personally? I do NOT think that woman had "definite" MS in the first place! (That is just my sole opinion.) If I do not, then I'd say she did not.

Or we BOTH DO have MS, and IF we do, then based on our presentation and examination results, it's a progressive form of MS, NOT RRMS! Which then again, takes her (and me) OUT of the criteria for any RRMS study trial in the first place!

Have a great day everybody.

Deb
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Postby amelia » Tue Jul 26, 2005 7:23 am

It goes to show that everything in treatment comes down to your Dr. and you had better have a good one. Don't accept the fact that a Dr. is an MS specialist, that he will be good with MS. 9 out of 10 probably are, but then there is that 1 Dr. that isn't. My husband goes to a very good neurologist that is NOT considered a specialist, but she is very up with research and new treatments for MS and its symptoms. On the other hand, our friend sees a MS specailist that had him on Betaseron. His liver profile started getting bad about a year ago, but he was still directed to take the Betaseron. The Dr would WATCH his blood tests for a while. NEVER telling my friend what was going on or could happen. Then recently he was instructed to stop the Betaseron because of serious liver issues and make an appointment with a gastrologist. To make a long story short, the Dr never told him what was going on, nor did the gastrologist. But he called my friend and alcoholic! He is an occasional drinker of beer. Very occasional. But the Dr never said anything bad about the Betaseron. He learned from me and my husband about the liver dangers with it. Sad that this Dr is a specialist, wouldn't you say? I learned a long time ago that you listen to your Dr, but you don't totally take their word for treatment, until you look into it yourself. :wink:
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Postby HarryZ » Tue Jul 26, 2005 5:19 pm

Amelia,

I can't count the similar type of stories that I have read on various MS forums about the same kind problems that your friend had with the "MS specialist"!!

Most of the readers on the various MS forums keep up to date on what is going and as a result, they are well informed and can make good decisions on their health care. But the vast majority of MS patients don't participate in these forums and rely totally on what their doctor tells them. And you have just described what is possible when this situation takes place. Allowing a MS patient to get to the point of liver damage when taking Betaseron and not telling him along the way is despicable!!!

Harry
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Postby OddDuck » Wed Jul 27, 2005 4:11 am

You know I agree, Amelia and Harry. Who can you trust, if you can't trust your physician? Especially with a disease like MS (or any neurological disease for that matter). What has the world come to?

And the medical field bashes the legal field! HAH! 8O :wink:

(Of course, there aren't all "bad" in either field, but it sure appears to be slim pickings as they say in the south.)

Deb
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