Biogen Idec, Elan Suspend Use of Tysabri

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

Postby Bigbooty » Mon Feb 28, 2005 7:14 pm

And now this little tidbit I just came across:

http://yahoo.reuters.com/financeQuoteCo ... 650_newsml
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Postby HarryZ » Mon Feb 28, 2005 7:29 pm

Bigbooty,

And some people say that it's not about the money!!!!

Thanks for the link.

Harry
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Postby flora68 » Mon Feb 28, 2005 7:33 pm

amelia wrote::cry: It is a very, very sad day for me and my husband. Why did I have hope in Tysabri? I watch my husband die a little more each day. I watch him fight, and I feel him take my life down with him. I always try to keep up a "happy" face and move on. BUT it is hard to do day in and day out. :roll: What next? Will the next drug be better? Will it be pulled? Who knows! It is just a very sad day. Maybe tomorrow I can look up and once more just keep hoping for something to stop this ugly disease.



Amelia, I'm so sorry :cry: . Bless your heart. There are so many people in despair about this, feeling lost or betrayed. Or maybe just plain :x mad. But this was just a battle, not the whole war.

Your heartfelt post made me want to know more about your husband's situation, so I went back and read most of your posts on this board, from the beginning, to see what poor Gary had tried so far for his MS. (Betaseron first, Copaxone now, right?)

Wow 8O Poor guy!

I mean, for starters, a freaking cow kicks him in the head, and after that MS pretty much took up where the dadgum cow left off, kicking the poor fellow around mercilessly for something like 25 years now. :cry:

And I thought I had problems.... :oops: Bless your weary hearts...

Amelia, has Gary ever considered taking LDN? I'm not suggesting it, really, just wondering. I just started on LDN recently myself, having also previously taken an interferon (Avonex) followed by Copaxone.

I wish I could say something to make you both feel better.....hang in there?
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Postby lurker1 » Mon Feb 28, 2005 7:55 pm

I had the good luck to have an appointment with my neuro today, a guy who was involved in clinical trials for tysabri (and up until 9 am a big proponent of the drug.) i asked him how he thought PML developed in the tysabri/avonex test cases and what he said wasn't far off from deb's interpretation.

he did, however, say that tysabri blocks both T-cells and macrophages, although it does allow in some other type of cell (neutillos? it starts with an "n" anyway). his guess on it (definitely a guess, his helping with the trials gives him no priveledged information) is that JC Virus was already present in the BRAINS of the people affected. which is different that what i'd read, which said that JCV laid dormant in the kidneys, i believe. if that's true then it doesn't matter even if they coat the BBB with kevlar, the tysabri model for curing MS by blocking the BBB will never work for many people, because we need an immune system in our brain for reasons that have nothing to do with MS. he called the JCV a "slow infection" which can never pick up speed unless it is totally ignored by the immune system (or if the immune system is totally prevented from reaching the infection). once the infection picks up speed, it becomes deadly and irreversible.

needless to say, this hypothesis makes it seem unlikely that removing avonex from the equation will eliminate the risk. it also opens up a new question-- is there a way we can be tested to find out if we're in the 30 percent who never contracted JC virus (probably because of natural immunity)?

i'd love feedback on this from people who know more about the physiology of ms in general. i'm not a good check on my neuro's hypotheses. besides his degree and his position, i have no real way of knowing how good a scientist he is. so do these extrapolations make sense?
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Postby Bigbooty » Mon Feb 28, 2005 8:08 pm

lurker
I'm no scientist either but one of the listed sx of tysabri is infection. I believe specifically infection of the CNS. ie. meningitis, encephalitis,rabies etc.
I never heard of PML before today but its apparently an infection.
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Postby flora68 » Mon Feb 28, 2005 8:45 pm

lurker1 wrote: -- is there a way we can be tested to find out if we're in the 30 percent who never contracted JC virus (probably because of natural immunity)?


lurker,

I'm clearly no scientist, but until one pops up to answer your question....

I don't know whether there is one, but I don't really see how a test for immunities to JCV would really help, because it's an opportunistic infection, i.e.: a virus that's benignly present all over the place, taking off in some people whose immune systems are supressed or otherwise dysfunctional, as in advanced AIDS.

So I don't see how one can count on 'natural immunity' when the immune system is being deliberately suppressed. Sort of like not being able to have one's cake and eat it too I guess...but I'm really just guessing and could be totally wrong.
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Postby Mulcher » Mon Feb 28, 2005 8:53 pm

The fda needs a complete overhall. They need to be audited. Biogen is a greedy company as shown in their tysabri + Avonex study. How much would that treatment cost us patients? Probably over 3 grand/month. What about the patients who had 1-2 infusions? The lawsuits will delay seeing tysabri for some time to come. How sad for all of us.
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Patient information.

Postby better2gether » Tue Mar 01, 2005 1:15 am

.
Patient information.

patient-1

Case 1: Confirmed

The following information is based on reports from the treating neurologist.

A 46-year-old female MS subject with a past medical history of depression and migraines received 37 doses of TYSABRI in combination with AVONEX as part of company-sponsored clinical trials. Her last dose of TYSABRI was on 18 Jan 05.

In Dec 04, the subject experienced right-sided weakness and aphasia, which was initially considered a MS relapse. A MRI revealed a left-sided 2 cm non-enhancing tumor like lesion. She was treated with two courses of steroids, one dose in Dec 04 and the other in Jan 05. Her symptoms continued to worsen with altered mental status and increased spasticity. She was hospitalized on 12 Feb 05. Neurological examination showed a non-responsive subject with right gaze preference, decorticate posturing, upgoing toes and no gag reflex.

A MRI showed “deep white matter, small vessel ischemic changes within the centrum semiovale periventricular regions, high signal throughout portions of the left temporal and left parietal lobes extending across the corpus callosum into the right frontal lobe.” This MRI appearance suggested a differential diagnosis that included PML.

Complete blood count was significant for a WBC of 14,000 and 29,000 cells/µL on 12 February and 15 February 2005, respectively (normal range 3,500-10,600 cells/µl). A lumbar puncture revealed glucose of 53 mg/dL (normal range 15-45) and protein of 90 mg/dL (normal range 40-70). Viral PCR testing of the cerebral spinal fluid (CSF) was positive for JC virus. HIV testing via Elisa was negative.

The subject was treated with intravenous methylprednisolone but her condition continued to decline and she was transferred to a hospice. The subject died on 24 February 2005. AVONEX neutralizing antibody status and TYSABRI antibody status were negative at baseline and weeks 24, 48 and 72.

Concomitant medications at the time of the event included vitamins, ranitidine, donepezil, tizanidine, zolpidem, and ibuprofen.

patient 2

Case 2: Suspected

The following information is based on reports from the treating neurologist.

A 46-year-old male MS subject with a history of melanoma, allergies and Bell’s Palsy received 28 doses of TYSABRI in combination with AVONEX as part of a company-sponsored clinical trial. His last dose of TYSABRI was on 13 Dec 04.

In December 04, the subject developed slow thinking, slurred speech and cognitive dysfunction, and a left hemiparesis, which later progressed to include left-sided sensory impairment in early Jan 05. An MRI scan in Jan 05 showed a right frontal lesion with no Gd enhancement, some degree of gray matter involvement, with the lesion extending beyond the right frontal lobe, also juxtacortical in the insular regions right and left, with no mass effect or edema.

He underwent an extensive work-up that included chest X-ray, chest and pelvic CT, PET scan and CSF analysis. The CT scans showed no malignancy. In addition, the subject tested HIV negative via Elisa. The subject underwent a brain biopsy on 16 February 2005. Preliminary results of the biopsy on 24 Feb 05 showed a demyelinating process, no vasculitis, no lymphoma, and no evidence of infection or malignancy. Viral PCR testing of the CSF for JC virus is pending. As of 25 February 2005, the subject was clinically worsening.

AVONEX neutralizing antibody status and titer levels are as follows: Baseline level=15, Week 24 was negative, Week 48 level=27, Week 72 level=30, Week 96 and Week 120 are pending. TYSABRI antibody status was negative at Weeks 12, 24, 36, 48, 60 and 72.

Concomitant medications at the time of this event included Levitra, Claritin-D, Benadryl, and Nasarel.

As of 25 Feb 05, the subject was clinically worsening. Given the appearance of the current and past MRIs and the subject’s clinical course, the investigator believes that this may be PML and is possibly related to TYSABRI.
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Biogen Conference Call Transcript:

Postby better2gether » Tue Mar 01, 2005 3:13 am

.
Biogen Conference Call Transcript:

Call to Discuss Tysabri Marketing Suspension



http://www.siliconinvestor.com/readmsg. ... d=21088871
.
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Postby OddDuck » Tue Mar 01, 2005 4:59 am

And now this little tidbit I just came across:

http://yahoo.reuters.com/financeQuoteCo ... 650_newsml


flora, in my research on Biogen, I speculated and said I had seen this "tactic" used many times in business before. It was a quick infusion of cash tactic. (I actually hate being proven correct.........this time.) I've said this before, and I'll say it again. I do this type of research for a living.

lurker: I would beg to differ with your neuro about the macrophages part. You can refer him to my research on VLA-4 antagonists, and which BIOGEN itself knew, also. I don't care if I'm "right", I'm just respectfully suggesting that if he researches it a little deeper, he'll see that he might have misinterpreted that assumption (that it blocks macrophages). That's how the virus got into the brain in these patients. Via the APC route THROUGH the BBB.

needless to say, this hypothesis makes it seem unlikely that removing avonex from the equation will eliminate the risk


lurker, I have to totally agree. I've been thinking about that a lot all last night (and overnight). Again, I speculated in my previous posts that what I see Tysabri may be better utilized as is a very short term treatment (just like the steroids are used) (and/or as Novantrone is used) for inflammation. BUT, again, Tysabri will end up having even more restrictions than that in the end. (Just my "guess", of course.)

Well, as better2together is beginning to post, here it comes. The groundwork for "narrowing" down the uses for Tysabri, so it can be placed back on the market. This one I WILL bet you on. I recognize this tactic, also.

Harry has been correct all along, also. I tried to back him up (because I knew he couldn't divulge confidences) by ALL my research I did on Biogen. If anyone wants to truly know what is going on behind the scenes (even just a LITTLE bit, and even that was enough for ME), I refer you again back to the thread I did when I researched Biogen as a company (that I posted in this thread earlier). EDIT: Oh, wait, I see I did NOT post it earlier....it's at: http://www.thisisms.com/modules.php?nam ... iogen+idec

Hey, call me crazy, I'm used to it.

Again, I'm SO sorry, folks. It literally makes me sick.

As for the FDA? Well..............even though I was almost tarred and feathered, I DID write to them, AND they answered (so I have written acknowledgement that they received my "warnings" about Tysabri and Biogen). That is called "gotcha" (speaking in legal terms). So, ptwo, if any news media wants to talk about anything, send them MY way!

Deb

EDIT: Besides, there ARE other methods to try to do what it was "touted" that Tysabri was going to do. I'll just leave it at that.

SECOND EDIT: I just wanted to put that sort of "notice to the media" in bold. Just in case. Like ptwo just mentioned, and for which I was tarred and feathered for mentioning previously, also........you just never know who reads our posts.
Last edited by OddDuck on Tue Mar 01, 2005 5:32 am, edited 3 times in total.
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Postby OddDuck » Tue Mar 01, 2005 5:06 am

Oh, and by the way, it isn't going to matter WHICH virus may be lying dormant in your system (we all have probably hundreds). Something like Tysabri could "activate" any one of them eventually.

And I say again..........you can strengthen the BBB by raising IL10. Easy, simple, painless. BUT.............not profitable.

Deb
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Postby OddDuck » Tue Mar 01, 2005 5:20 am

I went back just now to look and see what I said back in November regarding Biogen in that other thread. Here is something I'll copy here:

....This almost feels like an "all or nothing" move on their part. Either they are thinking of a quick "strike and make it rich" short-term viewpoint, or they have something else up their sleeve. Is Antegren just a "take off" point? Man.........still.........risky business they are up to.

WHY do I get a feeling that it isn't Antegren that they have up their sleeve, so to speak. Something else is in their pipeline somewhere.........under wraps. I could be wrong, but I've seen this "quick strike" tactic used before. In order to infuse funds quickly.

Getting interesting, huh? As far as from a patient's viewpoint? There is way too much business maneuvering behind the scenes in connection with Antegren for it to feel real "secure" to me. But that's just SOLELY my opinion.

Still, I'd take a cautious wait-and-see approach before jumping on the Antegren bandwagon.

Deb

EDIT: Oh, yea, and their big-wigs have been moving around stock like crazy. That much inside stock activity doesn't bode well. Whenever you see that, you can bet there's a hidden agenda going on. Check out the amount of SEC form 4 filings they've been doing lately.


No wonder they wanted to tar and feather me, huh?

Deb

EDIT: Oh, yeah! I forgot to mention to you all. I DID also write recently to the oftentimes hated and dreaded Michael Moore, who is trying to create a "behind the scenes" look at the world of pharmas and medicine. I'm sure I'll be tarred and feathered for that one, also.
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Postby OddDuck » Tue Mar 01, 2005 6:04 am

Sorry, I'm on a roll here for a second.

The article flora posted (thank you, flora EDIT: Oh, it was BigBooty who posted that article - my apologies) mentions Thomas Bucknum. I pointed and singled out Bucknum in my posts in the "Biogen Idec" company thread.

He is claiming that he had no prior knowledge of Tysabri's possible dangers.

Really? The reason why I singled him out previously was because of the fact that he came from Merck to Biogen. Merck had been previously studying VLA-4 antagonists, also, but slowed down (or stopped) because of its inherent "safety concerns". (Again, I refer you back to my research on VLA-4 antagonists. Those two threads lead into each other.) Anyway, in my SOLE "opinion", Bucknum HAD to "suspect" the underlying probable dangers because he was at Merck when they were studying it.

All I can say is "nice try", Bucknum. My apologies, but that response of his doesn't "fly" in my world.

As I said, even I (little peon me) noticed their "inside" stock maneuvering months ago!

Deb
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Postby Ptwo » Tue Mar 01, 2005 3:09 pm

I thought this was kind of interesting, from the NYT today:

But Lawrence Steinman, a professor of neurology and head of immunology at Stanford, said the F.D.A. should not have approved the drug on the basis of only one year's data. He said the risk of serious infections like P.M.L. was "unfortunately logical" given that Tysabri works by interfering with the immune system.

"I'm shocked that it happened so soon, but I knew it was going to happen sooner or later," said Professor Steinman, who participated in an early animal study that led to the development of Tysabri. Dr. Steinman is a co-founder and director of Bayhill Therapeutics, a company developing competing drugs for multiple sclerosis.

Dr. Steinman said he had expressed his apprehensions about the drug in speeches and in an article in the journal Science in July and had been asked by Biogen executives to tone down criticism of the drug.
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Postby OddDuck » Tue Mar 01, 2005 3:15 pm

Thanks for the info, ptwo! Hey, I can tell him Harry and I can "relate"! :lol:

By the way, IF anybody does care to (we can get some exposure for MS, folks) you can participate in an interview with the Bloomberg News, (John Lauerman). You should!

I'm going to talk with him tonight. Nothing to be afraid of. He's legit.

Deb
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