This Is MS Multiple Sclerosis Knowledge & Support Community

I really appreciate reading the info on this website. You all seem to be very 'thinking" individuals and I appreciate your input. I had 2 doses of Tysabri and now will start betaseron as soon as it all gets approved.

b2g, interesting post and nice commentary. Also figure into the additive effect the comments I posted in another thread regarding the 30% reduced clearance of Tysabri in the presence of Avonex. It's potentially yet another additive immunosuppresant effect to consider in the combination therapy (which at this point is looking like an absolute train wreck in the presence of such overwhelming evidence of risk)...

While we are all just speculating here, it seems Biogen has really done a number on Elan and Tysabri by insisting on testing the combination instead of being happy with Tysabri's effect alone. But again, that is all educated conjecture at this point.

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Arron wrote: While we are all just speculating here, it seems Biogen has really done a number on Elan and Tysabri by insisting on testing the combination instead of being happy with Tysabri's effect alone. But again, that is all educated conjecture at this point.

On the other hand, it's better that they found this in the relative small SENTINEL (Tysabri & Avonex) trial, than later, with Tysabri 2 or 3 years on the market.
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Thank you for your informative posts, better2gether & Arron. Keep it up. I learn from you.

RickR wrote:Thank you for your informative posts, better2gether & Arron. Keep it up. I learn from you.

So do I, as a matter of fact. Thanks again, Aaron and everybody.

indeed... but only if Tysabri is potent enough by itself to cause the opportunistic infection. And that, as they say, is the billion dollar question.

RickR-- thanks for your kind words. We're all in this together, learning from each other. It's obvious that even the best and brightest scientific minds in MS research have much to learn, so we shouldn't feel too bad about our own meanderings here ;).

After reading a number of excellent posts about the Avonex and Tysabri combination, I can't help but remember what Biogen's VP of medical research said on the NMSS webcast this past week....and that was the fact that because Avonex had 650,000 patient years of infection free use, he doubted very much if Avonex was the problem with PML. Sort of makes you wonder!

Harry

Just read this note on another MS forum and have copied most of it. It relates to this thread so you should find it interesting.

Harry

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I went to a msAA health fair today. It was the first time they have been to Central Texas. It was nice, they broke up into small groups. One group was with Dr. Edward Fox, the medical director for Tx NmsS, tysabri researcher, and director of the central Tx ms clinic. So this guy knows Tysabri. I will try to tell you some of what he said.
He said that 2 people have died. One was from California and the other from Portland Or.(I know this is up to debate, but that is what he said. He thought that tysabri would have to go back to studying with animal models. He was sad that they had even decided to do the combination and was sure Biogen and Elan was too.

So he couldn't say for sure how long that would take, but probably would not be quick. He felt like it was the combination of avonex and tysabri that caused the PML.

He said that out of the 600 people that received both drugs, 2 had died and that was incredible odds and he would not prescribe tysabri again until it was fully tested. There is other drugs in the pipeline such as rituxan but they are still at least 3 to 5 years away.

So the point he was making is that we are all having to go back to the way it was before Tysabri, at least for now. He was having very good results with it and this was the worst week of his life. They have set up a protocol for the ones that have taken tysabri for the patients safety. He didn't go into this much, but did say they had decided not to do LP, but definitely follow up MRI's.

He talked during lunch about the uncertainly of ms. He was trained by a dr in Houston that ran an ALS clinic. Dr Fox told this dr, that it must be hard to deal with ALS all the time. That dr said that ALS is predictable and he can tell his patients exactly what is going on and what will be happening next. 1 in 10 ALS patients are depressed and ms patients 9 out of 10. Weird huh? It was the unpredictability that was harder on both patients and drs.

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Tysabri - patient #2 - some good news!

Yesterday from another MS board...

" Hi Folks,

As some of you know, patient #2 recently confirmed to have PML is one of my colleagues. My project manager went to see him and just now reported that he is doing better this week than last week - he was eating macaroni and cheese and broccoli!!

<Kathy> Hi Guys
<Kathy> gxw-mtg, how is <name removed for privacy>?
<gxw-mtg> he's better than last week
<gxw-mtg> his father & brother were there, plus another friend
<Kathy> Good!
<Kathy> So, he's alert and all?
<gxw-mtg> his father wouldn't mind us calling him up next tuesday during our team mtg to lift up his spirits
<Kathy> excellent
<gxw-mtg> yes, he was eating macaroni & cheese & broccoli
<gxw-mtg> although he wasn't eating that much when i was there
<Kathy> I'm so glad to hear he's better!!!

I hope he can beat this thing!! I just hope his chances will be better because his immune system is DRUG suppressed rather than DISEASE suppressed. One would think that coming off the drugs would give him a chance to beat the PML.

Thanks to all of you who have sent positive thoughts his way. It's working!! "
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Better,

I read that message as well and then read the message about a person in Texas who went to an MS seminar recently. The doctor at that conference was emphatic about two patients in the trials that have died from PML. And we've heard about the patient who supposedly died from anaphylatic shock who insisted on receiving a second Tysabri infusion after having so much difficulty with the first infusion. And that patient may or may not have been one of the two patients that were reported to have died months ago.

One of these days we are going to find out what REALLY happened in the trials!!

Harry

Picked this up from another MS forum and it gives the opinion of a MS neuro who has been very close to the Tysabri trials.

Harry

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Here's what I learned last Friday from my neuro. Aside from being one of the country's top MS specialists, he's been conducting one of the combination trials and will also be on the panel that unravels exactly what happened and determines the future of Tysabri in April.

In other words, this is reliable and current info directly from one of the top experts.

I apologize if this is a repeat of old info. I haven't had time to really go over the board carefully, and I wanted to get this out there to people who might be anxious.

* YOUR RISKS *

Anyone who has had fewer than say, five, Tysabri infusions should *not* be concerned about PML. (Laurellynne, if you're reading this, I'm thinking especially about you and how distressed you've been. I mentioned your situation to him. I hope this is reassuring.)

If you've had more than that, talk to your doctor. It's almost certainly OK, since PML is so extremely rare, but obviously everyone is being very careful.

* TYSABRI'S FUTURE *

His overwhelming opinion is that Tysabri is doomed, doomed, completely doomed, and will not ever be coming back unless somehow it turns out that there was something rare and completely specific to these two patients that made them contract PML.

Even if it did come back, he would not feel comfortable prescribing it. He'd be calling his patients every three months saying, "Hello. Are you still alive?"

He was so terribly sad and disappointed, for the people who died, for the patients who were full of hope, and for the doctors who wanted to have a good med that could make a difference.

* THE RUMORS *

I brought up the issue of how many deaths, when, and all that sort of thing. Told him about the flying rumors about anaphylactic deaths in November. He was quite amused.

Guess what? There have been many, many deaths in the Tysabri trials. Things like bike accidents and sepsis and suicide. Things that clearly have *nothing* at all to do with Tysabri. Things that are definitely *not* anaphlyactic shock.

Because yes, the doctors and the drug companies are indeed legally bound to report those. They have to report *every* death. And anything that could be related to Tysabri *has* to be recorded as such.

So, no mysterious insider knowledge to be substantiated later. The rumors remain rumors. That's all they ever were.

Oh, I didn't ask about financial rumors. But I *did* ask if he thought there was any chance this could be pharmaceutical foul play. He didn't.

***

OK, here's my last point: One of the big problems I have with many MS meds is that they focus on immunosuppression. I am going to put in a plug for IVIg, which does the opposite. I have been on IVIg for roughly two years, and I think it is a *miracle* drug.

If any of you feel like you're running out of options, talk to your doctor about IVIg. Many neuros in this country are not familiar with it since it's fairly new here, so they may not think of it, but if you can get insurance coverage it can be amazing stuff.

See if you can try IVIg before moving to Novantrone, or after your Novantrone runs out, or while you're waiting for Aimspro (baaaaaaah).

All right, be careful out there.

"only" one person has died of PML thus far, and we hope that it stays that way. The doctor may have been going off an incorrect (and quickly retracted) AP story that stated the second patient died. We fell for the same trap here when we reported their erroneous story!

Arron,

Arron wrote:"only" one person has died of PML thus far, and we hope that it stays that way. The doctor may have been going off an incorrect (and quickly retracted) AP story that stated the second patient died. We fell for the same trap here when we reported their erroneous story!

That's what I figured as well about this story but I think the main conern within the medical world is the development of PML. Although rare, to show up twice in a relatively small group of trial patients has raised many eyebrows. They have to get to the bottom of this problem before Tysabri has any hope of being used again and at the moment, that is going to be Biogen's biggest challenge.

Take care.

Harry

Arron wrote:"only" one person has died of PML thus far, and we hope that it stays that way. The doctor may have been going off an incorrect (and quickly retracted) AP story that stated the second patient died. We fell for the same trap here when we reported their erroneous story!

Aaron,
I believe it was a mistake on the part of the original poster, probably not the doctor.

She did state in a later post that any mistakes were hers and hers alone.

cooly

Hi cooly, thanks for the information. it's reassuring... kind of...