Since it's still somewhat new Harry ... we may find out more as time goes on, but it's like that with any drug.

I get my 21st infusion on Friday. :)

Hi Wiz,

You are certainly correct in saying we'll find out more as time goes on...I just wish that I could put more trust in what Biogen tells us about this drug. Their reputation in the world of MS medicine isn't all that good!

Take care.

Harry

Now this is very interesting speculation as to why Tysabri may cause PML in the brain.

http://www.reuters.com/article/healt...4BF5GF20081216

Update
 

Here is an even better article on the subject from the researcher's home institution. An article this month in the Archives of Neurology addresses the reduction of brain immunity in people on Tysabri.

http://www8.utsouthwestern.edu/utsw/...es/505840.html

All, excellent publications, Natalie.. To Spite what Biogen thinks, the MS world knows how important it is, to keep Patients informed.....not frightened but informed.:)

Now I ask the question....do you not think that Biogen's researchers were aware of this possible problem from the beginning? They knew what Tysabri's mechanism of action was and surely must have known of this possible danger. I believe that Dr. Lawrence Steinman, one of Tysabari's co-inventors, made several references to the long term use of the drug and this very type of danger. Biogen had an answer for him a few years ago...told him to stop "bad mouthing" the drug!

Harry

Harry,

So, do we not offer drugs that have a chance of bad side effects? Don't we have to look at the overall effect? Let the patients know of any possible adverse affects and let them decide for themselves? Would you rather we not have Tysabri available as a treatment?

For myself, it has given me back a lot of my quality of life. All of these heavy duty drugs have their chances of dangerous side effects. If I take too much aspirin I might bleed to death.

So what do we do Harry? Take the Tysabri away? (And you know I'm not baiting you, I respect you as the caring spouse of someone with MS, your dear late wife.) Just trying to let you see the side of the patient that relies on Tysabri.

Yes, Harry, Biogen stinks..:mad:, but the truth is that, Ty is helping a whole lot of people to hold back the progression of MS.

The question has always been and will always be, do we want to take the chance with Tysabri and other dangerous drugs to slow the progression of MS? Some Docs and their Patients say no and some say yes.

I only ask that they keep us informed, so that our decisions are based on truth and not hype.

How are you doing, Harry..:hug:

I agree with Wiz and Sally.....provide the patient with all the information (good and bad) and let them make the decision as to whether or not they want to use that particular therapy.

Everyone's chemical makeup is different....what may cause a bad reaction in me may not cause it in someone else. It's a calculated risk we all take with everything we put into our bodies. Even things as relatively safe as aspirin and Tylenol.

Biogen-Idec reported yesterday that the US patient who was reported to have PML on Oct. 29, 2008 has died.

The death was likely as a result of IRIS from PLEX and treatment for PML. This is the patient who was 49 yrs old, female, previously treated with Copaxone,Beta-interferons and methotrexate for RA. She had received 14 infusions of Tysabri.

Her last methotrexate treatment was 4 months before starting Tysabri. It is unknown when she was last treated with interferons and Copaxone.

More information as and if it becomes available. Since this patient lives in the USA, there may be no further information available due to the HIPAA laws.

Wiz,

The question here isn't whether we offer drugs like Tysabri to the public but making sure this same public is given all the information required BEFORE making their decision.

If you can recall PRIOR to Tysabri becoming approved on the first go around....Biogen posted their marketing plan on the internet describing how it would be the first choice of treatment and within a year, have a huge share of the MS medication world. All their development costs would be recovered within 18 months!

It's this very approach that I am concerned about....promoting the heck out of a drug and then discovering all the problems afterwards. Let's get the revenue flowing and then worry about the fall-out later. Is this fair to the MS patient and/or doc who is trying to determine if the patient should use this drug?

I am glad to hear that Tysabri appears to have given you some quality of life back but wouldn't it have been better to know about these problems before you started on the drug? Again, my concern is that Biogen was aware of these potential problems but chose not to disclose them fully.

I'm not suggesting that we take Tysabri away but perhaps the FDA should be demanding more information from companies like Biogen. We know very well why Biogen strongly minimizes the potential problems of this kind of drug...it's very bad for potential sales.

At first we were told that the PML problem was due to combining immunosuppressive drugs. Then it was because the patient had taken this kind of drug in the past.....monotherapy was perfectly safe. And now we see monotherapy patients getting PML and subjected to other immune system problems. What else don't we know about Tysabri?

I also realize that you aren't baiting me in your questions. From reading your several posts I know that you simply aren't the kind of person who would do that and I respect your opinion.

Take care.

Harry

Harry,

My neuro would agree with you. I spoke to him today and he's generally not that fond of many of the pharma companies. Thanks for your concern. :hug: Hopefully it won't get much worse with the PML and other side effects. I just wish they'd come out with a pill that has low side effects really soon.

Seems Patient #3 with PML (in the US) has died :(:

UPDATE:Patient On Biogen, Elan MS Drug Dies Of Brain Disease

DOW JONES NEWSWIRES

By Thomas Gryta
Of DOW JONES NEWSWIRES

NEW YORK (Dow Jones)--A multiple sclerosis patient being treated with Tysabri, from Biogen Idec Inc. (BIIB) and Elan Plc (ELN), has died of a previously disclosed occurrence of a rare brain infection.

Biogen originally reported the confirmed case of progressive multifocal leukoencephalopathy, or PML, in late October. Tysabri, key to the future growth of both companies, is very effective in fighting MS, but a suspected link to PML led to its withdrawal from the market for 18 months beginning in 2005.

Patients on the drug are now closely monitored and four cases of the often fatal infection have occurred since its July 2006 relaunch, but the death may quell hope that PML could be a treatable side effect of the drug.

Shares of Biogen were recently down $1.15, or 2.4%, to $46.86, while Elan dropped 32 cents, or 5%, to $5.96.
The patient who died was the third case and the only one in the U.S. The other three are in Europe and remain alive.

A Biogen spokeswoman said that the company was informed earlier this week of the death and wouldn't disclose more information out of respect for the patient and her family.

The patient received 14 monthly infusions of Tysabri as a monotherapy and was previously treated with Teva Pharmaceuticals Industries Inc.'s (TEVA) Copaxone, Bayer AG's (BAY.XE) Betaseron and Biogen's Avonex. She also took methotrexate for a rheumatolgical condition.

All of the patients that developed PML were given plasmapharesis, a process that removes large molecules from the blood, speeding up Tysabri's removal and allowing the immune system to fight the PML infection.

When the drug is removed from the system, patients often experience an inflammatory response as the immune system reconstitutes itself, which can lead to their condition getting worse before any improvement is seen.

The death of the patient may temper arguments that the intricate distribution and monitoring program used for Tysabri, and use of plasmapharesis may ease the risk of PML for patients. Biogen has hoped that PML could eventually could be a "survivable adverse event."
But given the severity of PML, some believe that the death of a patient shouldn't be a surprise.

"We think the odds of surviving PML are still better than initially thought," said analyst Geoffrey Meacham of JPMorgan.

Tysabri's label implies that one in every 1,000 patients could get PML, but the actual number remain well below that ratio. As of Sept. 30, more than 35,500 patients use Tysabri, with 9,500 patients on it for at least 18 months and 3,700 for more than two years.

Steven Harr, an analyst with Morgan Stanley, writes that the recent death may demonstrate that Tysabri's risk is consistent with the label, to the disappointment of some investors and physicians that thought it might actually be lower.

-By Thomas Gryta, Dow Jones Newswires; 201-938-2053; thomas.gryta@dowjones.com

http://www.djnewsplus.com/article/DN...Brain+Disease+

All sources of information, even the co-founder of Tysabri, need to be questioned. I'm not saying that Biogen played fair (I don't know the details) but Lawrence Steinman runs his own pharmaceutical company, Bayhill Therapeutics, that is working on its own MS drug to be taken once a month. I believe Phase IIb trials are starting now. Competition? You betcha. It's a multi-billion dollar market out there and it seems that money will always drive the process to initiate new MS drugs. That's how the pharmaceutical industry works. And unfortunately, one of the by products of the free market is the unwanted or unexpected effects on the patients who take these drugs. The same thing goes on in the pharmaceutical market for anti-depressants.

By the way, just look at what Steinman's company says on its website regarding its drug, BHT-3009.

"BHT-3009 is an antigen-specific plasmid encoding myelin basic protein (MBP) that has the potential to gain a significant share of the multi-billion dollar MS market as an effective treatment with limited side effects and a superior administration profile."

http://www.bayhilltherapeutics.com/BHT-3009.html

$$$$$ play a role in everything. And what might Steinman's company not be telling us during their process to gain a share of the market? I'm not a diehard pro-Tysabri advocate or defender necessarily. Just playing devil's advocate.

Steinman could have hung in and cashed in on the Tysabri glory . . . but walked away when he realized the danger, WAY back when. He has been researching and testing other methods ever since . . . and why wouldn't he? He believed Tysabri was a time-bomb long before most others would suggest that.

Cherie

We don't know what Stenman's company will or won't tell us...that remains to be seen. But we do, however, know how Biogen handled the introduction of Tysabri, don't we? Combined it with Avonex before the drug was even approved by the FDA....outlined their market plan in detail on the net before the drug was approved.....conducted "staged" netcasts creating a "this is the MS drug of the century".....delayed telling the public about PML for a few weeks so their execs could cash in on $$$ millions in stock sales...

I could go on and on and yes, I fully realize that big pharma is driven by the almighty dollar and not by the health benefits to patients. I just find it disgusting that a company like Biogen has again placed MS patients in a precarious position in how they handle Tysabri....something that MS patients really don't need on top of fighting this lousy disease.

Harry

As an update to this post:

I can find NO 8k from Biogen on this patient.

I cannot find any mention of this announcement on Biogen's site, where any announcement from Biogen to the public is always posted as it is announced.

There is no cause of death listed in any of the news reports about this announcement.

The death was reported to Biogen, according to news reports, but no further details are available in any news reports I have read.

In my previous post, I speculated on the likely cause of death and posted "The death was likely as a result of IRIS from PLEX and treatment for PML"
That is my opinion and not fact, since no cause of death has been published.

Thanks and carry on...:)

Biogen has admitted that she had PML, by way of a 8-K form already:

http://www.sec.gov/Archives/edgar/da...2762bie8vk.htm

Even if it is ultimately IRIS that killed her, that doesn't make things any prettier. PML, IRIS . . . they are BOTH wicked "side-effects", and that would just mean that Tysabri caused a double-whammy for her. :rolleyes:

Biogen's spokespeople have also announced her death in many articles:

http://www.newstin.co.uk/tag/uk/94432260

http://www.google.com/search?sourcei...L+patient+dies

Form 8-K "is the current report companies must file with the SEC to announce major events that shareholders should know about." Shareholders already know this lady had PML, so there may be no further obligation to file with the Securities and Exchange Commission (SEC) when a person dies from a previously reported medically induced disease. :confused:

Cherie

I understand that many many articles written by financial reporters and news reporters can be found by googling them, Cherie. I am not stupid.

What I do NOT find is the original announcement by Biogen, nor do I find an 8k, which the SEC requires when ANY material event that may affect the share price of a listed company's stock happens. This includes patients previously reported as having contracted a disease that may or may not be from the use of that company's product dying as a consequence of taking that drug.

I find a lot of speculative articles about the event, along with speculations about what caused the death.

While there is a very good chance that this patient died from IRIS, I refuse to speculate further as to how she died until more information becomes available, but thanks for your input.

IRIS with PML is often referred to as PML-IRIS because, as I understand, the use of plasmapheresis (to treat the PML) may cause the IRIS. Either way, IF she ultimately died from the previously announced case of PML, or from IRIS due to the treatment used to slow the devastation of PML . . . the chain reaction would clearly start with the use of Tysabri.

http://investorvillage.com/mbthread....wall=1#6097376

They will likely want to wait on autopsy results BEFORE they might intend to officially “announce” the cause of death and/or file an 8-K form (if that even occurs). In the meantime you are as entitled to “predict” her death might not be related to the PML, as I am to “speculate” that it was. ;)

"Biogen says Tysabri PML patient dies in U.S.

Fri Dec 19, 2008 9:52pm GMT
By Toni Clarke

BOSTON (Reuters) - Biogen Idec Inc said on Friday that a multiple sclerosis patient who had been diagnosed with a rare brain infection while taking its drug Tysabri has died, sending the company's shares down nearly 3 percent.

Biogen and its partner Elan Corp Plc disclosed the case in October. Naomi Aoki, a spokeswoman for Biogen, said the company learned of the patient's death earlier this week.

Tysabri is seen as crucial to the growth of both companies. The drug was temporarily withdrawn from the market in 2005 after it was linked with a rare brain infection known as progressive multifocal leukoencephalopathy, or PML.

The drug was reintroduced in July 2006 with stricter safety warnings.
So far, there have been four new cases of PML, an infection rate that is still less than the one in 1,000 warned of in the drug's label. Nearly 18,000 patients have received at least a year of Tysabri. But investors are watching to see if the rate increases, and they are also looking at how successfully patients can recover.

"While we continue to believe the benefit/risk profile of Tysabri as favorable, we believe this death could lead the FDA and physicians to alter how future PML cases are managed," said Christopher James, an analyst at Rodman & Renshaw.

The patient who died was a United States patient who had received 14 monthly infusions of Tysabri as a stand-alone treatment. Previously she had received other therapies.

After developing the brain infection, the patient was treated with a procedure known as plasmapheresis, in which blood is removed, cleared of the drug, and replaced.

While the U.S. patient died, two patients who developed PML in Europe, and whose cases were announced in July, appear to be recovering following treatment, even though one had not been expected to survive. Earlier this month, Biogen announced that a fourth patient had developed PML. This patient, in Europe, is still alive.

The European patient that had not been expected to survive had developed a condition known as immune reconstitution inflammatory syndrome, or IRIS. This occurs when the immune system, in eliminating an infection, produces an excessive inflammatory response that can worsen symptoms.
The patient was treated with corticosteroids.

Geoff Meacham, an analyst at J.P. Morgan, said it seems likely the U.S. patient, having gone through plasmapheresis, died of IRIS, and that since the European patient recovered, it might be possible to manage IRIS using steroids and close monitoring. Biogen declined to confirm this theory, citing patient privacy.

"In our view, the rate of PML is now critical to assessing the launch trajectory, and the regulatory outlook, should it stay in the 1/1000 range," Meacham said in a research note."

http://uk.reuters.com/article/health...BrandChannel=0

Cherie

TMI, Redundant, TMI!!! Sheesh!!:D

June of 2007, I was asked to participate on an FDA panel as an MS Patient Advocate to evaluate the RiskMAP for the TOUCH protocol for Tysabri. Some of you may remember the extensive questionnaire (anonymous) I sent out for your to fill out.

I was the first speaker of the first day of the 2-day conference. I had 15 minutes to present this information. I spent almost 2 weeks putting it all together in a power point presentation.

Biogen was the first speaker on the 2nd day of the Conference. It was obvious to all that their presentation was redone as their speaker did not match their slide presentation and my name was mentioned more than once.

My point being that the FDA is monitoring Biogen and Tysabri. After that conference and since then, the labeling and monitoring process has changed. Biogen had hoped to have the black box warning label removed. It will never happen. Biogen and the FDA are well aware of the risks involved with Tysabri. No drug is 100% safe, I don't care who you are or what the drug companies say...there is no such thing as a 100% safe medication. Period.

As to the publication or notification to the patients of the risks involved of Tysabri -- It's called informed consent. I am not saying that Biogen is doing everything they are supposed to be doing, but there are MANDATORY, not ADVISORY, requirements that must take place before the patients have their first infusion of Tysabri.

Please take a look at the track record of other drugs on the market. Sometimes adverse events/side effects aren't known until the drug has been on the market for well over 10 years, sometimes longer. This drug has only been on the market since 2004.

It was the first new drug on the market to treat MS in almost a decade. It was clearly stated at the first hearing in 2005 that there WOULD BE, not MAY BE, PML cases reported. I was there, I heard it. The FDA heard it...any one who listened to the transcripts of the hearing heard it. None of us are stupid, as RW stated.

PML is going to happen. It was predicted by Biogen. It was predicted by the FDA panel when they approved the drug to be returned back on the market. That was the reason for the TOUCH protocol. That was the reason for the PML Tracking system. That was the reason for the evaluation of the TOUCH protocol every year.

Now, let's look on the positive side. How many people has this drug helped to have a better quality of life? How many people have other drugs helped have a better quality of life that have a much higher death rate? Aspirin is always a good example, tylenol is another one. Do they pull those OTC drugs from the market, no. They don't even lower the stock market price of the makers of these drugs...not even a blip on the radar. Does it make the headlines...NO WAY.

I am not trying to lessen the degree of this lady's death in any way shape or form. It's sad. Very sad. But this one ups man's ship stuff has got to stop. The reporters are the ones who are letting this get out of hand - again - and some of you are taking the bait. Let's let the experts, like say her doctor, report what her REAL cause of death was, before jumping to conclusions and picking fights.

There are a lot of people on this forum (and others) who are benefitting from the drug and don't need all this negativism right now. Reporting facts is one thing, but continuing to belittle one's opinion who is actually taking the drug is unbecoming and serves no purpose.

Let's stick to the facts and stop speculating.

Why is it that every time someone gets PML and/or dies from it after taking Tysabri, there are others in this forum who feel the need to imply "I told you so!" This is very insensitive and not helpful to people taking Tysabri. :( What new information do we learn each time? Not much. But we get the same old tired debate where those on Tysabri are made to feel like dummies being duped by Biogen. Life with MS is already hard enough. And it's the Christmas season so let's be supportive of one another and thoughtful about what we say.

I continue to find it difficult to understand why some people equate other's comments about being very cautious with Tysabri as "negative"!


If Biogen is so aware of the dangers of Tysabri, then why have they pushed its introduction into the marketplace so fast from the very beginning? They have run into hurdle after hurdle with this drug as more problems surface as each month passes. It's safety has been questioned from the outset and although all drugs have a risk level associated with them, Biogen's method of operation seems to push ahead as fast as they can and worry about the problems afterwards when they show up.

I and others for months have pointed out the concern we have for this drug as it gets used by more and more patients. It isn't being "negative" but simply giving another point of view.

Harry

*This is the place to ask questions, get information, talk to people who are on Tysabri, and help each other out.*

The information about PML has been posted as it was reported, as has this death. When more information becomes available, it will be posted.

Please keep this thread to the spirit and reason for which it was started.

Harry I do believe you are missing my point. I am not going to debate it here. This is not the place. And I am not going to continue this useless commentary any longer. Sorry...it serves no purpose whatsoever.

Merry Christmas. :)

3rd PML patient cause of death unknown
 

The cause of death for this patient is only speculation.

The cause of death could have been PML. While the Tysabri was removed from the system, the immune response may have been delayed/affected by prior methotrexate treatment. I don't know how long this drug may affect immune response.

The cause of death could have been IRIS. Inflamation from the immune response could have worsened the syptoms and resulted in death. Maybe the PLEX should be less aggressive.

The cause of death could have been complications due to the patients rheumatological condition.

The cause of death could have been due to some other hospital or outside acquired infection.

From Biogen's 8-k

" Patient had also received prior therapy with methotrexate for a rheumatological condition. "

ditto.

this is not a thread for the nay-sayers of tysabri to post on.

this thread was made for those who are on tysabri or thinking about it to get information and support. from those who have first hand knowledge. people who have been on it or are on it.

the article and information about the person who had died was first posted in a responsable manner. others popping in with the "i told you so's" type of posts do not belong here. when all of the facts are reported (autopsy results i imagine) they will be posted. until then, yep, it's all just speculation.

natalie expressed it well.

some good news!!
 

Finally, some good news in this MS journey! I had an MRI after my 6th infusion of Tysabri. No enhanced lesions, no new lesions--everything looks just the same as it did before I started the drug. Whoohoo!! Now I am off to California to celebrate the holidays, my birthday, and no new lesions!!!

That's great news, Natalie! :) Congratulations.....and enjoy your holiday! :hug:

Oh, almost forgot.....Happy Birthday!

Happy Birthday Natalie!! :)

http://dl6.glitter-graphics.net/pub/...a1j2faq5tb.gif

Way to go on the good MRI's!! :)

Thanks Wiz! B-day is 10 days and counting. This will be a better holiday season than last year. A year ago I was at the Mayo Clinic the day after Christmas getting the MS confirmation news and being told my brain looked like swiss cheese! Cheers to no additional holes this year!
:trampoline: :yahoo:

Natalie!

During this Holy Season, it's WONDERFUL to hear your un-holey news! :D

Please have fun in Cali and forget the fact that you have MS and enjoy the holiday!!!:hug:

Hi everybody! Well, I have some not so great news. :(. Although my mri latest mri is stable, I've decided to stop Ty. I've been getting worsening headaches (disabling pain, I guess equivalent to a migraine) immediately after each infusion even though I take the Tylenol and Claritin before. They last for more than a day. I also get bodyaches, chills, and a low-grade fever. After discussing this with my neuro and my dh, I've decided to stop after my 10th infusion. I hope I'm making the right decision. ARGH!! I'm just so pssd off that these dam drugs keep failing me in one way or another! Thanks for listening.

I'm sorry Joelle. :hug: Why does the treatment so often have to be as bad or worse than the disease? :(

I hope you'll find a treatment that will be tolerable for you. :hug:

Ahh Joelle,

I am so very sorry to hear this.
It sucks when you expect that a drug will help and it doesn't work or the side effects are worse than the affliction that you are taking the drug for!

Please know that you are in my thoughts and prayers. Please keep in touch and let us know how things are going for you! I've been thinking of you lately and I am glad to see you post.

The good news is that your MRI showed stabilization. That in itself is a positive thing.

I wish you joy and peace this holiday season, my friend. :hug:

Sorry to hear that this hasn't worked out for you, Joellelee. :(

Have you tried anything else yet? Did you have (worse or just as bad) side-effects from them as well? Perhaps T is actually the 'least of all evils' ... :confused:

I have a terrible time with many meds too, so I know your predicament.

You have had a rough year, and hope 2009 is better for you. :hug:

Cherie

I've been on interferon, Copaxone, and Ty. Next stop...LDN. I'm not giving up just yet :).

Joelle,

I am sorry to hear about ty, but the news about your mri is good. I understand how you feel.

Hi Joelle, So sorry to hear about your problems with Tysabri. I get a fever from the Ty. sometimes too. But I understand your frustration. I had a tough go-around with every other drug--it's upsetting when you feel like your body won't cooperate. Glad to hear the MRI is positive news. :hug: