new PML case

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

new PML case

Postby ursula » Thu Oct 30, 2008 7:37 am

"..."Since the last two cases were disclosed we've had about 3,000 patients on the drug -- about 1,000 a month ... I think every case that comes along next will have minimal impact as long as that rate stays about 1 in 1,000," said Cowen & Co analyst Eric Schmidt..."

http://www.reuters.com/article/marketsN ... 029?rpc=44

This ist just sad....
[/b]
ursula
User avatar
ursula
Family Member
 
Posts: 82
Joined: Mon Sep 22, 2008 3:00 pm
Location: germany

Advertisement

Postby CureOrBust » Thu Oct 30, 2008 5:17 pm

I am not on Tysabri, and have been offered it by my neuro.

The article you read is from "Reuters", a financial reporting organisation, using interviews from traders and analysts who are only interested in the "numbers" and how it affects the share prices. You could ONLY expect non empathetic responses and quotes. The quote you took was from a market analyst, who's job is to specifically be concerned with effects on the stock price, not human lives lost. I wouldn't of expected anything less. The analyst was not from Biogen, but "Cowen and Co".
User avatar
CureOrBust
Family Elder
 
Posts: 2910
Joined: Wed Jul 27, 2005 3:00 pm
Location: Sydney, Australia

Postby ursula » Fri Oct 31, 2008 2:43 am

You are right..
But Biogen itself issued a similar announcement for the investors after the last 2 PML cases.

Let´s hope that in the future there will be drugs without so severe side effects..
ursula
User avatar
ursula
Family Member
 
Posts: 82
Joined: Mon Sep 22, 2008 3:00 pm
Location: germany

Postby Loobie » Fri Oct 31, 2008 5:01 am

That's my hope as I get ready for my first infusion. It was scheduled for yesterday, but my infustion nurse called in sick, so it will probably be today or Monday. At any rate I hope Tysabri works for me, but I have been thinking that I just want to be on it as a stop gap until something better comes along, because even though the percentages are low, when you do develop some of the side effects, they seem to be pretty bad. Almost like flying; the odds of a crash are pretty low, but your odds IF you are in that crash really suck.
User avatar
Loobie
Family Elder
 
Posts: 2196
Joined: Mon Sep 11, 2006 3:00 pm
Location: Dayton, Ohio USA

Postby av8rgirl » Fri Oct 31, 2008 6:13 pm

Loobie wrote:That's my hope as I get ready for my first infusion. It was scheduled for yesterday, but my infustion nurse called in sick, so it will probably be today or Monday. At any rate I hope Tysabri works for me, but I have been thinking that I just want to be on it as a stop gap until something better comes along, because even though the percentages are low, when you do develop some of the side effects, they seem to be pretty bad. Almost like flying; the odds of a crash are pretty low, but your odds IF you are in that crash really suck.


I've been in a plane crash. The plane was totaled and I walked away, bruised up pretty bad, but survived. I also had two infusions of Tysabri before it was pulled from the market.

I am still a pilot and until a few years ago competed in aerobatic competitions. I still fly. When your number is up, your number is up. Be positive...
“When everything seems to be going against you, remember that the airplane takes off against the wind, not with it.” - Henry Ford
User avatar
av8rgirl
Family Elder
 
Posts: 216
Joined: Thu Apr 03, 2008 3:00 pm

Postby Loobie » Sun Nov 02, 2008 5:12 pm

I will try my hardest. After the Tovaxin debacle (that's what it was for me; no slow down, like I was getting nothing for two years) I am just not all that 'hyped up'. I want to be because the positive attitude makes you feel better, but I just have to be pessimistic until I feel something.

Congrats on walking away from a totalled plane!! That must have scared the shit out of you. I used to manage a company that had a Cessna Congquest II (bad ass plane if you ask me!), and there were some times I was freaking out in that bad boy due to weather, but the pilot always calmed me down. I actually ended up much preferring that plane to commercial. It may have had a bumpier time through the haze layer and was generally a little bumpier, but at least it could glide if necessary!
User avatar
Loobie
Family Elder
 
Posts: 2196
Joined: Mon Sep 11, 2006 3:00 pm
Location: Dayton, Ohio USA

Postby msladyinca » Sat Nov 15, 2008 2:49 pm

Regarding the cases of PML, in a recent MS seminar - Dr. Roby, a MS specialist at Temple University Hospital - stated that ALL of the PML cases involved patients that either had other unknown health issues, or that they were previously on other strong immunosuppressant medications such as Remicade, Imuran (azathioprine), Methotrexate, etc., which can still have lasting effects month/years even after the medication has been discontinued by the patient.

His estimate of developing PML while on Tysabri is now 1:20,000.

Lauren
Feel free to visit my Blog and leave me a comment, I'd love to hear from you! :)

http://lauren-livingwithms-aolcomlglbgl ... gspot.com/

Co-owner of a MS Support Group
User avatar
msladyinca
Family Elder
 
Posts: 104
Joined: Sun Aug 13, 2006 3:00 pm
Location: So. Calif.

Postby HarryZ » Sun Nov 16, 2008 10:18 am

So now we have MS patients taking Tysabri that have "unknown health issues" or have used other immunsuppressive drugs in the past!! Hmmm....that would pretty much cover all MS patients these days. You would think that any responsible doctor would check this out BEFORE prescribing this drug.

First Biogen told us that it was only MS patients who had taken combo drugs that were effected by PML after using Tysabri. Now after monotherapy with Tysabri, other health issues and distant past drug use are an issue. Recent studies by researchers have started to indicate that Dendritic Cells and CD +4 T cells are greatly reduced when taking Tysabri. Another study I read states that the immune system is being compromised by this drug.

While using Tysabri or any drug becomes a benefit vs risk issue, patients have to be informed about "all" the possibilities before making their decision. The long term use of Tysabri by MS patients is still very much unknown. Let's hope that it doesn't become more of a problem over time.

Harry
User avatar
HarryZ
Family Elder
 
Posts: 2557
Joined: Tue May 25, 2004 3:00 pm
Location: London, ON, Canada

Postby msladyinca » Sun Nov 16, 2008 5:27 pm

You are wrong Harry...,

First Biogen told us that it was only MS patients who had taken combo drugs that were effected by PML after using Tysabri. Now after monotherapy with Tysabri, other health issues and distant past drug use are an issue


Initially, Biogen reported that the two trial cases of PML developed in two patients that did not have MS (one patient was misdiagnosed as having MS & the other patient had Crohn's Disease)..., the third trial patient that developed PML did have MS and used both Avonex and Tysabri together. That is the only trial patient that developed PML in the combination setting.

Furthermore, it was not Biogen that stated "other health issues" and "distant past drug use" are an issue. Dr. Roby stated that in a MS seminar.

"Distant past drug use" is a serious issue when discussing the past use of very strong immunosuppressants such as Remicade, Imuran (azathioprine), Methotrexate, etc., that can last years in the system even though they have/had been previously discontinued by the patient. This is what has caused the immune system to become so diminished that it opens the patient up to developing PML.

Lauren


Feel free to visit my Blog and leave me a comment, I'd love to hear from you! :)

http://lauren-livingwithms-aolcomlglbgl ... gspot.com/

Co-owner of a MS Support Group
User avatar
msladyinca
Family Elder
 
Posts: 104
Joined: Sun Aug 13, 2006 3:00 pm
Location: So. Calif.

Postby HarryZ » Sun Nov 16, 2008 10:08 pm

Lauren,

There were 3 patients that were initially diagnosed with PML. Two had been on the Avonex and Tysabri and one had Crohn's.

Anita Smith, the misdiagnosed MS patient died and that was attributed to the combo treatment. The second combo patient survived but from what I have heard, is in terrible shape. The Crohn's patient also died and we were told about his past use of immune-suppressive drugs. Even though he had stopped using these drugs 7 months earlier and was in relatively good health despite the Crohn's, starting the Tysabri infusions very quickly caused his death.

The last two PML patients in Europe were on Tysabri treatment only.

Now I ask the questions....with Tysabri being a drug that heavily changes the way a person's immune system reacts, why on earth would Biogen combine it with Avonex (another drug that alters the immune system) BEFORE the drug was ever approved in the first place?

Why was the Crohn's patient given Tysabri when the docs knew his past use of other heavy duty immune-suppressive drugs?

With the recent studies showing how Tysabri's longer term use is detrimentally effecting patients' immune systems, (and Biogen knew very well of this dangerous possibility as even one of Tysabri's co-founders warned them about this) why were they in such a hurry to rush this drug to market?

We all know the answer to this...it's $$$$.

I will admit that when I first heard about Tysabri (Antegren at the time) from my wife's neurologist, I was excited about it. He was one of the docs doing the trials. But as I saw how Biogen handled the drug's release, I became more and more skeptical. Hec, this neuro told me a long time ago that Biogen's reputation for providing accurate data to the MS medical community was very suspect.

I'm glad that some patients like yourself are doing well on the drug. But I also fear that we have only seen the tip of the iceberg with the potential problems it is going to give MS patients. We continue to hear more and more reasons as to why Tysabri is not good for patients who are not in the best of health in the first place and have taken other immune-suppressive drugs in the past. Again, why are we hearing this NOW and not BEFORE Tysabri was massed released?


Harry
User avatar
HarryZ
Family Elder
 
Posts: 2557
Joined: Tue May 25, 2004 3:00 pm
Location: London, ON, Canada

Postby ursula » Mon Nov 17, 2008 4:31 am

I agree that too many drugs come far too early on the market.
Often it´s like russian roulette.
No one knows about the long term side effects.
Sometimes I really wonder why the FDA couldn´t wait long enough?

I am very sceptical about ANY of the releases from Biogen.
After all Biogen is really struggling to get the 100,000 Tysabri users they promised to the investors.

"Biogen said last week that 35,000 patients worldwide were being treated with Tysabri and it continued to expect that 100,000 patients will be taking the drug by 2010."

http://www.reuters.com/article/rbssHeal ... 4920081029

Maybe in 5 years nobody will be talking about Tysabri anymore.
Only one thing is sure at the moment:
There will be more PMLs /Herpes/other infections in the future.
ursula
User avatar
ursula
Family Member
 
Posts: 82
Joined: Mon Sep 22, 2008 3:00 pm
Location: germany

Postby msladyinca » Mon Nov 17, 2008 4:42 pm


Harry,

I still don't see where you admit you were wrong when you misstated the following:



First Biogen told us that it was only MS patients who had taken combo drugs that were effected by PML after using Tysabri. Now after monotherapy with Tysabri, other health issues and distant past drug use are an issue


You explained yourself, but you still do not apologize for your misstatements.

You then state:


The last two PML patients in Europe were on Tysabri treatment only.


Yes, both of those patients received Tysabri as a monotherapy, however you should know the following:

One of those patients was a Swedish MS patient with a highly aggressive form of MS, having up to 10 (I believe) very large lesions showing on his prerequisite MRI prior to starting Tysabri therapy..., while this MS patient was naïve to MS therapies, I find it hard to believe that his treating neurologist did not try to control the numerous and severe relapses he was having with something, such as "pulse steroids"... but we will never know until this patient's prior medical history is released. At least, his neurologist was very vigilant in monitoring this patient, and this case of PML was diagnosed early (within the first month I believe) and after plasmapheresis exchange, he is home, ambulatory, and doing well.

The other patient was a German MS patient that had been on beta interferon therapy as well as steroids & Imuran (azathioprine). Again, azathioprine's effects can linger in the body for years even after discontinuation, so obviously this patient was immunosuppressed to begin with. Furthermore, this patient's case of PML was not diagnosed until much later, and additionally, he continued to receive Tysabri as well as steroid treatments until he was formerly diagnosed with PML. He too received plasmapheresis exchange, and remains hospitalized.

All of the above information was gleaned from the reports that were released to the public.

You then asked:


why on earth would Biogen combine it with Avonex (another drug that alters the immune system) BEFORE the drug was ever approved in the first place?


I cannot speak for Biogen, but in my opinion, obviously they were trying to gain the full benefits of Tysabri plus Avonex in the Sentinel trial which were still ongoing at the time (when I say "full benefits", I mean monetarily as well as the efficacy being shown for the patients which was coming from the data in the Sentinel trial).

Lastly, you ask:


Why was the Crohn's patient given Tysabri when the docs knew his past use of other heavy duty immune-suppressive drugs?


Why don't you ask his doctor? I know that you claim to have information that this patient was in good health, but I dispute that theory because if he was in such good health, why was he on any medication all? This gentleman was previously on Imuran (azathioprine), Remicade, as well as intermittent steroid use. I feel bad for this family's loss, but I highly doubt that he was in good health. Just my opinion.

With the recent studies showing how Tysabri's longer term use is detrimentally effecting patients' immune systems


It is easy to make claims such as that, but difficult to prove any authenticity to such claims. Please provide a link for these "recent studies" you claim to have knowledge of. I have not seen any data from any recent studies claiming this "longer-term use being detrimental to the patients' immune system".

Once and for all you ask:


Again, why are we hearing this NOW and not BEFORE Tysabri was massed released?


Tysabri was mass released with a Blackbox Warning of a 0.1% risk of developing PML in certain patients (like the immune suppressed patients) that have been treated with Tysabri for 14 months... THAT is why Harry. (Sigh)

Lauren
Feel free to visit my Blog and leave me a comment, I'd love to hear from you! :)

http://lauren-livingwithms-aolcomlglbgl ... gspot.com/

Co-owner of a MS Support Group
User avatar
msladyinca
Family Elder
 
Posts: 104
Joined: Sun Aug 13, 2006 3:00 pm
Location: So. Calif.

Postby HarryZ » Mon Nov 17, 2008 9:08 pm

Lauren,

I still don't see where you admit you were wrong when you misstated the following:[/color][/size]



First Biogen told us that it was only MS patients who had taken combo drugs that were effected by PML after using Tysabri. Now after monotherapy with Tysabri, other health issues and distant past drug use are an issue


Wrong?!! I haven't changed my statement from the original message...only further elaborated on it. And I repeat again...Biogen first told us about the two initial PML patients just after their execs sold their stock and made millions of $$$$. Those two patients were on Avonex as well as Tysabri. One died and one survived if you call his current state "surviving". James Mullen, Biogen's CEO, immediately made the statement that in hundreds of thousands of Avonex patient months, they had never seen a case of PML. He was protecting his cash cow, Avonex.

The second PML patient to die was the Crohn's patient. Nothing has changed!

Regardless of the Swedish patient's situation, he was given Tysabri and contracted PML. You are indeed right in wondering why his doctor gave him the Tysabri because the drug has not been proven effective against aggressive MS. The last thing this patient needed was PML and then having to go through plasmapheresis.

And the German patient's situation points out exactly what my concern is about Tysabri....there simply isn't enough known about it's safety when used on this kind of patient yet the drug is being given to these people!

All of the above information was gleaned from the reports that were released to the public.


Just like Biogen has gleaned out concerns about Tysabri over the past few years...like when they told Dr Steinman to stop telling the public that Tysabri was a dangerous drug and would eventually cause problems.

[color=blue][size=14]I cannot speak for Biogen, but in my opinion, obviously they were trying to gain the full benefits of Tysabri plus Avonex in the Sentinel trial which were still ongoing at the time (when I say "full benefits", I mean monetarily as well as the efficacy being shown for the patients which was coming from the data in the Sentinel trial).


One reason and one reason only, Lauren....monetarily. It doesn't take a rocket scientist to figure that one out.

And now the Crohn's patient. This patient's relatively good health was no theory....he WAS in decent health. He was retired and enjoyed fishing and hunting. He had been in the Tysabri trial but had been receiving the placebo. His docs decided to give him the Tysabri after he had been off these other drugs for several months. His blood work prior to starting on the Tysabri was quite normal. After 3 infusions, his white cell count started to skyrocket and it wasn't long after that the PML began and he eventually died. The docs thought it was a brain tumor but the medical evidence at the time did not make sense to the family. When further investigation was done and PML found to be the culprit, the family was told to "keep it quiet"!!! They have sought legal advice. You can doubt what I am telling you and that is your perogative but it is all very true.

[color=blue][size=14] It is easy to make claims such as that, but difficult to prove any authenticity to such claims. Please provide a link for these "recent studies" you claim to have knowledge of. I have not seen any data from any recent studies claiming this "longer-term use being detrimental to the patients' immune system".


Do you really think that I sit at night and "invent" this information??!! Go and look in the Tysabri forum and read my post on the first study. The second study that I read about was on another MS Forum. If I find it in the next day or so, I'll post it.

[color=blue][size=14]Tysabri was mass released with a Blackbox Warning of a 0.1% risk of developing PML in certain patients (like the immune suppressed patients) that have been treated with Tysabri for 14 months... THAT is why Harry. (Sigh)


And now we are starting to learn that Tysabri is doing other bad things to patients' immune systems. Things that several docs predicted many months ago would likely happen. It's just not the PML. That is why, Lauren....double sigh!!

Harry
User avatar
HarryZ
Family Elder
 
Posts: 2557
Joined: Tue May 25, 2004 3:00 pm
Location: London, ON, Canada

Postby ursula » Tue Nov 18, 2008 2:14 am

Lauren, you wrote:
I cannot speak for Biogen, but in my opinion, obviously they were trying to gain the full benefits of Tysabri plus Avonex in the Sentinel trial which were still ongoing at the time (when I say "full benefits", I mean monetarily as well as the efficacy being shown for the patients which was coming from the data in the Sentinel trial).


So who are you?
The official spokesman of Biogen Idec in every MS forum?

There simply is nothing positive to be said about the Tysabri/Avonex trial.
This is just a shame.
They only wanted to make extra money with their own drug Avonex, completely ignorant about the risks for the guinea pigs.

So what are you driving at?
Tysabri in Monotherapie isn´t so dangerous?
Even the biogen people expect further PML cases to happen.
Last edited by ursula on Tue Nov 18, 2008 5:24 am, edited 1 time in total.
ursula
User avatar
ursula
Family Member
 
Posts: 82
Joined: Mon Sep 22, 2008 3:00 pm
Location: germany

Postby CureOrBust » Tue Nov 18, 2008 5:00 am

ursula wrote:There simply is nothing positive to be said about the Tysabri/Avonex trial.
Yes there is, we all now know not to mix the two, and it gave everyone a heads up that suppressing the immune system while on Tysabri, was not a good thing. Its a major pity the way we found out.
User avatar
CureOrBust
Family Elder
 
Posts: 2910
Joined: Wed Jul 27, 2005 3:00 pm
Location: Sydney, Australia

Next

Return to Tysabri (Antegren or Natalizumab)

 


  • Related topics
    Replies
    Views
    Last post

Who is online

Users browsing this forum: No registered users


Contact us | Terms of Service