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Monday February 28, 8:43 am ET

Biogen Idec, Elan Suspend Use of Tysabri After Fatality in Clinical Trial


CAMBRIDGE, Mass. (AP) -- Biotech companies Biogen Idec Inc. and Elan Corp. reported Monday that they have suspended marketing and clinical trial use of multiple sclerosis treatment Tysabri and alerted doctors to stop using the treatment.
Biogen Idec shares closed Friday at $67.28 on the Nasdaq and were down $27.79, or 41.3 percent, to $39.49 in premarket activity, while Elan shares closed Friday at $26.90 and plummeted $16.39, or 61 percent, to $10.51 in premarket activity.

The suspension was triggered by two serious adverse events, resulting in one fatality, involving the drug in clinical trials. The companies reported the adverse events were one confirmed and one suspected case of progressive multifocal leukoencephalopathy, a rare and frequently fatal demyelinating disease of the central nervous system.

http://biz.yahoo.com/ap/050228/biogen_i ... bri_2.html

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Biogen, Elan Voluntarily Withdraw Tysabri
Monday February 28, 8:56 am ET

Biogen, Elan Voluntarily Withdraw Multiple Sclerosis Drug Tysabri After Patient Death


BOSTON (AP) -- Biogen Idec Inc. and Elan Corp. announced Monday they have voluntarily withdrawn Tysabri, a drug used to treat multiple sclerosis, after one patient died and another developed a serious disease of the central nervous system after taking it in combination with another drug. Stocks of both companies tumbled in premarket trading.


The companies said in a news release that they have suspended supplying and marketing the drug and advised doctors to suspend prescribing the medication. The companies also have stopped using the drug in clinical trials.

They said the decision came after recent reports of two cases of serious effects among patients who used it along with Avonex in clinical trials. In one case, the person died, while in another, the person developed a suspected case of progressive multifocal leukoencephalopathy, a rare and frequently fatal disease of the central nervous system.

Both patients had taken Tysabri for more than two years in combination with Avonex, the companies said.

"Our ongoing commitment to MS patients has led us to take these steps," said Dr. Burt Adelman, executive vice president of Development at Biogen Idec. "Because we believe in the promising therapeutic benefit of Tysabri, we are working to evaluate this situation thoroughly and expeditiously. While we work through this matter, we must place patient safety above all other considerations."

The companies said they took the action after consulting with the U.S. Food and Drug Administration.

"We are working with leading experts and regulatory agencies to responsibly investigate these events and to develop the appropriate path forward," said Dr. Lars Ekman, executive vice president and president of research and development at Elan. "Our primary concern is for the safety of patients."

http://biz.yahoo.com/ap/050228/ms_drug_ ... ion_4.html
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First off, I'm sorry, genuinely sorry for the distress that this development will surely bring to those who've put so much faith and trust in Tysabri, and who were anxious to get on with Tysabri therapy. But since the danger apparently came with use of Avonex together with Tysabri, maybe Tysabri alone will be re-released after it's truly had and passed adequate studies....

Secondly, I hope that those who energetically took the defense or offense when it came to Tysabri discussions on this board (including myself), will be able to sincerely wish each other well and just move on. (Please?)

Let's face it, our choices of MS treatment regimens are made from a baffling list of apparently imperfect treatments. And it seems to me that when we put our faith in one particular treatment, and endure the attendant risks, side effects, costs and/or other difficulties, we need to feel that we've made the right choice. I know I certainly do.

And when we further open our choices to debate and discussion on this (or any) MS discussion board, we have to really be ready to hear others explain why they deliberately chose differently. And being human, many of us feel personally hurt or insulted when we hear that someone else has emphatically rejected our choice as a poor one.

But I'm sure that nobody here ever wanted to cause anyone else any distress; we're just came here to share resources and support, right? But sometimes we just get carried away, trying to help others see the Light that we hope we're already basking in....it's all very tricky, isn't it? Being human while fighting MS.....



"I'm jes trying to get along without shovin' anybody around, that's all."
--"Tom Joad" in "The Grapes of Wrath"

Better,

Thank you for posting this information.

I and a few other readers have stated often that Biogen/Elan was rushing Tysabri into the marketplace. Several MS docs stated they weren't comfortable with the lack of data about the drug and that the FDA approved it with little information. Carefully crafted press releases raised MS patients' hopes but some MS professionals quietly voiced their concerns. This, of course, was attributed to "rumor mongering" and "hearsay". Now we have a situation of huge damage control by Biogen/Elan, crushed hopes by MS patients and Biogen's already suspected reputation in the medical world taking a severe blow. Most, if not all of this, could have been avoided if they had only followed the standard protocol of bringing a drug to the marketplace. How very, very sad!

Harry

And I rest my case.

And get this, I WROTE to the FDA and warned them, didn't I?

That's all I've got to say. I'm sure that's enough.

Deb

flora68 wrote:First off, I'm sorry, genuinely sorry for the distress that this development will surely bring to those who've put so much faith and trust in Tysabri, and who were anxious to get on with Tysabri therapy.

Well said Flora! I read this news and felt really down - and Tysabri was never an immediate proposition for me (no EU evaluation for a year at least). Rightly or wrongly Tysabri has caused a real buzz on the MS wires hasnt it?

The little bit of "luck" I have had wrt my dx is only that it came to me post-internet. I cannot begin to imagine how to endure the (relative) isolation of a dx 20 years ago. But had it not been for the net I probably would never had heard of Tysabri. !?

I logged on to make a posting which simply said "Thanks!" That is thanks to Aaron for hosting the site and thanks also to everyone who posts with whatever degree of academic knowlegde but always, I feel, with honesty. I think it is more relevant and more timely now.
Please keep it up everyone - I suspect there will be some hands to hold as this bad news disseminates.

I think I'm literally going to cry. This all could have been avoided.

Well, for what it is worth, I'm here if anyone needs.............anything.

Deb

Thanks, John. And I certainly share your appreciation of Aaron and this site, and the good and helpful people who post here. Bravo!

I also totally share your gratitude at the fortunate timing of our MS diagnoses. I mean, WHEW! Can you imagine being diagnosed in 1935? Or even in 1965? The family doc I work for said that doctors used to put off telling patients that they had MS as long as possible, because MS was such a hopeless situation, and the stress of just knowing about it sometimes literally sickened people.

Not that anyone (except maybe a drug company or two ) actually celebrates a new diagnosis of MS these days, but at least now we know a lot more, and we actually have some treaments, each of which subsantially helps at least some people. And we have this brilliant tool, the internet, to enable us all to share the kind of complex information once strictly reserved for health professionals. I can't count the times when, upon reading something on the net, my hopes have taken flight.

I guess today shows that this free and immediate access to hot-off-the-presses, maybe not-quite-ready-for-primetime treatment breakthroughs sometimes has a price, doesn't it? And a steep one at that; our hopes can be made to soar, but they can crash and burn too just as quickly. That's really rough, on top of having MS in the first place, isn't it?

So, again, my sympathies to those who's hopes have just been unceremoniously bumped from their flight. But definitely stand by, because something else wonderful will surely be along before too long. Meanwhile, love from Texas to all who are hurting today....be extra nice to yourselves.

does anyone know anything about progressive multifocal leukoencephalopathy? not to cause panic-- i'm sure anyone on just a few months' combination treatment has nothing to worry about. but if only to better understand MS, the blood-brain barrier, and the demylenation process, why might avonex and tysabri taken together create an opening for this rare disorder?

This gives me the chills after what I went thru this weekend over on MSW. I was only preaching caution,got ripped up for it and now this.

I'm truly sorry for the families of those people. And oddDuck your right. The FDA is virtually useless in this counrty at this moment. Hoefully this will bring about changes.

Thank you for the kind words. I feel quite "wrong" today... I think a lot of people do.

But knowledge is power... we'll kick some butt soon

BigBooty,

Not to sound too negative regarding the FDA, but they approved this RIGHT after the whole Vioxx scandal came out.

And on one of the shows on tv just a week or two ago (I don't know 20/20 or Dateline or something) there was a spot on there regarding the FDA. It was said that something like almost 50% (someone correct me if I'm wrong, if you also watched the show, but I know it was high) of the FDA's financial support comes from pharmaceutical companies themselves!

I immediately cringed, because talk about "conflict of interest"! Good Heavens!

lurker1, I'll go refresh my memory, but if you look back on my previous thread and research regarding VLA-4 antagonists, I mentioned in there some things about certain specific cytokines, and the fact that even though Tysabri blocks T cells from crossing the BBB, it does NOT stop macrophages from crossing! Macrophages will cause demyelination or at least damage. I mentioned, also, that due to the fact that Tysabri blocks ALL T cells (even the good ones), but does NOT stop the macrophages, what might this cause? You DO want SOME of the good T cells to cross.

Again, if you would like, I'll go back and refresh myself, do a bit more research and post a few things. Right now, I'm only guessing. I need to become re-familiarized with leukoencephalopathy, too. I do recall, though, that I ran across that during my research on VLA-4 antagonists before. I just gotta go back and re-read, etc.

Deb

lurker1 wrote:does anyone know anything about progressive multifocal leukoencephalopathy? not to cause panic-- i'm sure anyone on just a few months' combination treatment has nothing to worry about. but if only to better understand MS, the blood-brain barrier, and the demylenation process, why might avonex and tysabri taken together create an opening for this rare disorder?

Progressive Multifocal Leukoencephalopathy

Progressive multifocal leukoencephalopathy (PML) is a rare disorder of the nervous system that primarily affects individuals with suppressed immune systems -- such as patients with cancers leukemia, lymphoma, or acquired immune deficiency syndrome (AIDS).

The disorder, which is caused by a virus, is characterized by demyelination or destruction of the myelin sheath that covers nerve cells. The myelin sheath is the fatty covering -- which acts as an insulator -- on nerve fibers in the brain.

Symptoms of PML include mental deterioration, vision loss, speech disturbances, ataxia (inability to coordinate movements), paralysis, and, ultimately, coma. In rare cases, seizures may occur.

There is no cure for PML, nor is there currently an effective treatment for the disorder. Treatment is symptomatic and supportive.

The course of PML is relentlessly progressive. Death usually occurs between 1 and 4 months after onset.

Information provided by the
National Institute of Neurological Disorders and Stroke,
National Institutes of Health


Article Created: 1999-03-14
Article Updated: 1999-03-14

Ok....I already know how and why I ran across it.

PML is caused by an acute infection from what is called the "JC Virus" due to an "inadequate immune response system". Bingo.

In that other thread (somewhere) I cautioned about how likely it might be for "infection" to run rampant with Tysabri. As I was also extremely afraid of, Tysabri is an extreme immune "suppressant".

If you combine an immunosuppressant (Tysabri) with an immunomodulator (like the CRABS, with probably the exception of Copaxone), you are asking for possible trouble.

http://www.healthatoz.com/healthatoz/At ... opathy.jsp

Although at least 80% of the adults in the United States have been exposed to JC virus (as evidenced by the presence of antibodies to this virus), very few will develop PML. Little is certain about what causes JCV to produce active disease, but the virus persists in the kidneys of otherwise healthy people without making them ill. Recent evidence suggests that after prolonged compromise of the immune system, the virus changes into a form that can reach brain tissue and cause disease. In PML, the JCV infects and kills the cells (oligodendrocytes) that produce myelin, which is needed to form the sheath that surrounds and protects nerves. ....

Currently, there is no known cure for PML....

PML is usually a very aggressive disease. The time between the onset of symptoms and death can be as little as one to six months. ....

I'm SO sorry, everybody. SO sorry! I tried to express "caution".

http://www.thisisms.com/modules.php?nam ... opic&t=564

http://www.thisisms.com/modules.php?nam ... opic&t=601

Deb

lurker1 wrote:does anyone know anything about progressive multifocal leukoencephalopathy? not to cause panic-- i'm sure anyone on just a few months' combination treatment has nothing to worry about. but if only to better understand MS, the blood-brain barrier, and the demylenation process, why might avonex and tysabri taken together create an opening for this rare disorder?

Well, you've already got your answer, but here's a link to the best site I've ever found on PML or Progressive Multifocal Leukoencephalopathy. (Some of the AIDS patients I worked with had it.)

http://www.ninds.nih.gov/disorders/pml/pml.htm

I've noticed one important bit of misinformation about this situation that's popped up more than once today in news articles and in posts....regarding PML, the condition that caused the sudden halt in Tysabri use. Hopefully this error was totally inadvertant, but my cynical side won't rule out the possiblilty that this little mis-statement might have been a deliberate attempt at damage control .

PML is not, I repeat, NOT "sometimes" or "frequently" fatal. It's always, always 100% fatal. And rapidly fatal at that. Almost all PML patients succumb within 1-4 months of diagnosis.

I guess we can all see that the biggest risk in rushing something to market at warp speed is precisely what happened here; serious, even fatal consequences that occured when least expected, after 2 full years of what looked like safety and success.

DES daughters like myself and certainly thalidomide victims and others have to carry the results of that risk constantly. For us, a "brand new, breakthrough" drug already has a strike against it, in terms of unknown future risks.

You know what, though? I'll bet it'll be quite awhile before we see the FDA fast-tracking anything for a condition that isn't usually fatal. Meanwhile, I hope none of you actually invested in it, as the early release of Tysabri had inspired a few posters here to consider doing.