This Is MS Multiple Sclerosis Knowledge & Support Community

Until I get more information, I will reserve judgment and be patient to see what develops from this episode. I am hoping this sad occurence might shed light into the causation of MS and if and how a virus might play a role.

Hopefully this is just a "2 steps forward, 1 step back" experience although the deaths are not the step backwards I'd prefer. I am encouraged in what noted MS neurologist Howard Weiner said this week, "Tysabri advanced our understanding of MS and the treatment of it in very real ways."

HarryZ,
It appears that you may have misinterpreted my comments. If you look at Feesher's original post, my post, as well as your follow-up to my post, then I think you'll see that both you and I are really on the same side of the fence with respect to Avonex.

Best wishes, NHE

Xenova,

Xenova wrote:I don't know if a two year study would have made a difference. One victim had 36 treatments which I assume is 3 years. The other was at 24 treatments or 2 years but I don't exactly what month that fell in on the calendar.

If Biogen would have completed the two year study before applying for FDA approval, the data required for that approval would not have been available until later this month or perhaps the end of April. The death reports would have come out before the approval was granted and the proper investigation would have taken place. And perhaps the Biogen execs wouldn't have sold their stock and made millions!!

Harry

NHE,

Forgive me if I misinterpreted your message but I thought it stated that the problem with Tysabri was due to combining it with an interferon and that using an interferon on its own was OK.

Biogen's VP of medical research indicated that Avonex wasn't likely the problem in the PML patients because of its track record. So the combination of an interferon with Tysabri may not have been what caused the PML. Although he didn't elaborate further, I would have to presume that Tysabri alone would be the culprit, combination aside, if indeed that's what they eventually determine as the problem.

At this point it's far too early to tell and finding the answer isn't going to be easy because of the very nature of PML.

Take care and sorry if I didn't understand you properly.

Harry

I changed my message because I realized how stoopod it was. I must have had a bad day. Welcome to my world.

.
Associated Press

Friday March 4, 4:49 pm ET

By Shawn Pogatchnik, Associated Press Writer

Elan, Biogen Confirm Second Patient Who Used Suspended MS Drug Has Contracted Rare Disease


DUBLIN, Ireland (AP) -- A second patient taking a recently suspended multiple sclerosis-fighting drug, Tysabri, has contracted a rare disease of the central nervous system, the Irish and American companies who developed the highly touted medication confirmed Friday.

Elan Corp. of Ireland and Biogen Idec Inc. of Cambridge, Massachusetts, had announced Monday that they were withdrawing Tysabri because one patient had died of progressive multifocal leukoencephalopathy, a usually fatal disease, while a second patient was suspected of developing PML.

The two companies said Friday that a second patient's suspected case of the disease had been confirmed, but he was still alive.

Tysabri had been approved in November by the U.S. Food and Drug Administration following promising clinical trials that demonstrated the drug's ability to prevent relapses in many MS sufferers.

The drug was being used by about 3,000 MS sufferers in the United States and 22 people in Ireland before its withdrawal from the market. Tysabri was also withdrawn from clinical trials on sufferers of Crohn's disease and rheumatoid arthritis.

Both patients were taking Tysabri with Avonex, an older MS-fighting drug developed by Biogen Idec. It has remained on the market.

The companies stressed in a joint statement that, for now, there was no evidence that either drug taken on its own was linked to PML.

"To date, the companies have received no reports of PML in patients receiving Tysabri monotherapy for MS or in patients with Crohn's disease or rheumatoid arthritis," the companies said.

"Biogen Idec has not received any reports of PML in patients treated with Avonex alone, a product on the market since 1996."

Earlier this week Elan Chief Executive Kelly Martin insisted that the company was hopeful of reintroducing Tysabri -- Elan's key drug -- to the market later this year.

http://biz.yahoo.com/ap/050304/ireland_ ... on_17.html

Better,

The bottom line here is that nobody knows what caused the PML other than it happened to two patients who were in the trial and both were getting the Tysabri. It's going to take months and months to get all the proper answers if that's even possible.

In the meantime, thousands of MS patients are devastated and having to decide with their doctors what to do. Many docs told their patients who went on Tysabri that the CRABs that they were on weren't of much use anyway and caused too many side-effects. Now they are in the awkward position of having to possibly start them back on the CRABs!

Thank you Biogen!

Harry

I thought this was an interesting post from a member of Braintalk.

I hope it's OK to post it here.

------------------------------------------------------------
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.

Coolycat,

coolycat wrote:I thought this was an interesting post from a member of Braintalk.

I hope it's OK to post it here.

I hope it's OK since I posted it in one of the other Tysabari threads earlier

I was told that Brain Talk does not allow you to post messages taken from other threads. I'm not sure exactly why they don't allow that.

Harry

Hi Harry,
Well, I guess if you saw that one, you saw this reply to the original post, I thought this was quite interesting as well.

-------------------------------------------------------

I had heard much the same information about Tysabri from a different source. I hope they are able to identify who is at risk for developing PML, or HHV-6 reactivation, or whatever, and reintroduce a product which is safe for those who use it.

I did some literature searches on PML and learned that (e.g.) Cytoxan + steroids have been associated with the development of PML as well. In fact this study stated that "More than 20 cases of PML or cerebral nocardiosis in patients receiving corticosteroids and cytotoxic drugs for rheumatic disease have been reported."

a very interesting thought that has been raised on other threads today is if PML is caused by artificial immunosuppression, then lifting the immunosuppressive agents (such as tysabri/avonex/steroids) would potentially let a person's otherwise normal immune system get things back under control... boosting the immune system with antiretrovirals might help that as well...?

we will see, in the form of the fate of the second PML patient... and we will keep him in our thoughts and prayers.

coolycat wrote: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.

Perhaps I'm confused about this but it seems to me that sepsis could very well be directly related to Tysabri since it functions by blocking white blood cells from crossing out of the circulatory system into infected tissues. My neurologist was involved with the Antegren trials. In early 2000 shortly after I was diagnosed, he offered to accept me into the trial. The information he gave me was that Antegren was not specific to the blood brain barrier but affected the circulatory system as a whole. At that time, I chose not to go on the experimental trial due to the unknown risks and also due to the fact that there were other drugs available which were already proven to be of benefit. Another factor in my decision making process was the 33% chance of being in the placebo treatment group.

If any of you feel like you're running out of options, talk to your doctor about IVIg.

I'm not familiar with IVIg, but it sounds very much like an IV administered antibody. It would be great if you could share more detailed information on this treatment. For example, how does this antibody differ from Tysabri/Antegren? Which protein is targeted by the antibody?

NHE

I have no personal experience with IVIG.

Here are some links.

http://www.msadvances.com

http://www.infusionsystems.net/PDF/...parisonData.pdf

I know my best friend is bummed...she only got one treatment of Tysabri, before they pulled it...and she was very happy with it.

Her neurologist (whom i don't like) he's very abrasive, and constantly talks over us...he doesn't listen AT ALL...he said it will be at least a year before Tysabri comes back, and that is not even a certainty...he won't hear of anything like ldn or anything, he is starting her back on Avonex, which she went off of cause of all the flu like symptoms...she was on it for over 2 years, and they never went away...

He did tell her that she was on the highest dosage and maybe that is why she was feeling sick (of course im thinking,,then why didn't you lower it back when she was taking it and getting sick?) so, he would prescribe a lower dose...well she got it delivered today, and guess what? it's the same dosage, and she's so upset, she is not even going to call him..she is just going to give herself half the shot....which worries me...does anyone know of anyone who has ever done that? and have there been any effects??

Thanks for listening.

Peggy

WEll, my best friend is right back to the flu like symptoms, after only one shot of Avonex...up all night, couldn't sleep, body aches, headaches, sick to her stomach...so i guess 1/2 a shot didn't help.

she called the neurologist's office, and they told her, that they should hear something about the Tysabri in about 2-3 weeks, which I find hard to believe,,but I sure hope it's true, cause she doesn't handle the avonex well, and would love to go back on the tysabri.

Has anyone else heard about the tysabri, maybe making a comeback?

Peggy