Flora,
I even compared Tysabri to Thalidomide! (Or did you realize that?)
They are both the same "class" of drug - they mess with "integrins".
God, I think I'm going to be ill. Seriously.
Deb
Biogen Idec, Elan Suspend Use of Tysabri
It was the strangest sequence of events this morning...First I got a phone call confirming my 1:00 appt. for my Tysabri infusion this afternoon then 5 min. later I got a call canceling today's appt. because the drug was taken OFF the market! So at first I felt disappointed in that this new drug which was helping me to some extent (moreso than Copaxone, Rebif and Novantrone had) was now unavailable. Then I felt glad that the drug companies and the FDA are keeping track of harmful side effects. I have an appt. this Friday with my neuro to discuss the next best step...kind of a rollercoaster of emotions.
Well, it certainly didn't take very long for those vultures to start circling, did it? 
This was on the sponsored links side of a Google search of "Tysabri":.
"Sponsored Links
Tysabri Recall Lawsuit
Tysabri Taken Off Market. Free Case
Evaluation for Side Effects Victims
http://www.yourlawyer.com
This was on the sponsored links side of a Google search of "Tysabri":.
"Sponsored Links
Tysabri Recall Lawsuit
Tysabri Taken Off Market. Free Case
Evaluation for Side Effects Victims
http://www.yourlawyer.com
Last edited by flora68 on Mon Feb 28, 2005 12:03 pm, edited 1 time in total.
)deb,
thanks for the informative reply. do you think there's anything to be learned from this either about the mechanism of MS or the function of interferons? this is, after all, one of only a few cases we can look at of chemical changes in the body (i.e. drugs) affecting the health of people (not rats) with MS (not some rodent equivalent). For instance, could jcv have anything to do with ms? (someone must have looked into this already.)
i wish i could be more productive instead of just raising questions, but i have very little science background and i'm still not so familiar with internet medical resources. thanks to everyone who is helping.
thanks for the informative reply. do you think there's anything to be learned from this either about the mechanism of MS or the function of interferons? this is, after all, one of only a few cases we can look at of chemical changes in the body (i.e. drugs) affecting the health of people (not rats) with MS (not some rodent equivalent). For instance, could jcv have anything to do with ms? (someone must have looked into this already.)
i wish i could be more productive instead of just raising questions, but i have very little science background and i'm still not so familiar with internet medical resources. thanks to everyone who is helping.
flora68 wrote: .......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 fatal" 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.
WARNING: Those who need to maintain faith in the integrity of the makers of Tysabri should absolutely read no further. Seriously. (No slayer of illusions nor doubter of Santa Claus be Ms Flora
)I found the primary source of the misinformation I mentioned earlier that under-played the recent risk associated with Tysabri, referring inaccurately to PML as being merely "frequently" fatal.
You'll never guess who.....
http://www.elan.com/Images/TYSABRI_Lett ... 3-8191.pdf
.
Hi, lurker,
The short answer here is probably "no". There is nothing that happened in this circumstance that brought up anything "unknown" really. Sort of like "if you do this, then this will happen" or will likely happen.
They already knew that particular virus caused PML. And they suspect viruses, as only one, contribute to MS. And it was already known that totally suppressing the immune system was risky and why. (If I could put two and two together, you KNOW they did. And if not, we ARE in a rough sea!)
It's the "mutations" of the viruses that complicates matters, also.
I believe selective targetting of specific cytokines in MS is a must, if you are wanting to modulate the immune system at all in MS. There is enough proof to substantiate that theory to a pretty high degree of accuracy.
I'm sorry.
Deb
Oh...and you don't want to forget macrophages and antigen presenting cells when you treat MS. T cells just aren't the "lone" problem in MS.
EDIT: That's not to say that Tysabri won't yet be useful in some "specific" types (patterns, not merely classifications of progressiveness) of MS, but I will say again.........here and now.........it just won't be for every circumstance and for everyone with MS. Its use is going to be extremely narrow and targetted. BUT, I could be wrong.
The short answer here is probably "no". There is nothing that happened in this circumstance that brought up anything "unknown" really. Sort of like "if you do this, then this will happen" or will likely happen.
They already knew that particular virus caused PML. And they suspect viruses, as only one, contribute to MS. And it was already known that totally suppressing the immune system was risky and why. (If I could put two and two together, you KNOW they did. And if not, we ARE in a rough sea!)
It's the "mutations" of the viruses that complicates matters, also.
I believe selective targetting of specific cytokines in MS is a must, if you are wanting to modulate the immune system at all in MS. There is enough proof to substantiate that theory to a pretty high degree of accuracy.
I'm sorry.
Deb
Oh...and you don't want to forget macrophages and antigen presenting cells when you treat MS. T cells just aren't the "lone" problem in MS.
EDIT: That's not to say that Tysabri won't yet be useful in some "specific" types (patterns, not merely classifications of progressiveness) of MS, but I will say again.........here and now.........it just won't be for every circumstance and for everyone with MS. Its use is going to be extremely narrow and targetted. BUT, I could be wrong.
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HarryZ
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Flora,
Interesting info you posted on PML and the response by Elan.
I don't know how many times I commented on the mistrust I had about Biogen/Elan and the poor reputation Biogen in particular had within the medical community when it came to honest data reporting. Several people accused me of having an "agenda" against Biogen and Tysabri. We are now starting to see just why I made the comments that I did. I tried to explain that these comments originated from MS professionals but that didn't seem to matter.
Again the sad part in all of this is the crushing effect this recall is going to have on thousands of MS patients around the world.
Harry
Interesting info you posted on PML and the response by Elan.
I don't know how many times I commented on the mistrust I had about Biogen/Elan and the poor reputation Biogen in particular had within the medical community when it came to honest data reporting. Several people accused me of having an "agenda" against Biogen and Tysabri. We are now starting to see just why I made the comments that I did. I tried to explain that these comments originated from MS professionals but that didn't seem to matter.
Again the sad part in all of this is the crushing effect this recall is going to have on thousands of MS patients around the world.
Harry
Harry, do you know of any particular reason to believe that Biogen/Elan is, well, more ethically-challenged than, say, the other MS drug makers like TEVA? Or major manufacturers of other meds as in Merck or Bayer?HarryZ wrote:Flora,
Interesting info you posted on PML and the response by Elan.
I don't know how many times I commented on the mistrust I had about Biogen/Elan and the poor reputation Biogen in particular had within the medical community when it came to honest data reporting....
Harry
I don't.
I mean, they're there first and foremost to sell a product, and from what I've observed, their bias in terms of disclosing or conceling their product's risks vs their competitors' is enormous and utterly shameless.
In the family practice office where I work, I'm in charge of dealing with the drug reps who come in, as well as their literature and their samples. And while they're oh so pleasant, handing out pens and pads and other goodies to all, I see them as nothing more than well-dressed, well-spoken, very slick door-to-door salespeople, bubbling over with inflated good news about their products, and studiously avoiding or minimizing any discussion of the attendant risks or limitations.
And, despite the feel-good commercials and group-hug websites, I see drug companies themselves as nothing nobler than profit-making corporations who exist primarily to prosper financially off the suffering of others, not primarily to help anyone but themselves and their stockholders. Making as much money as possible is their focal mission.
Speaking of which, I gotta get to work.
It is a very, very sad day for me and my husband. Why did I have hope in Tysabri? I watch my husband die a little more each day. I watch him fight, and I feel him take my life down with him. I always try to keep up a "happy" face and move on. BUT it is hard to do day in and day out. What next? Will the next drug be better? Will it be pulled? Who knows! It is just a very sad day. Maybe tomorrow I can look up and once more just keep hoping for something to stop this ugly disease.
amelia: that is exactly the pain we are all feeling. Thank you for putting it into words so eloquently. Keep your head up though, turning cynical for a moment, this is a big market and that means lots of $ and motivation for the big companies to churn out products.
Tysabri, if nothing else, showed that it was possible to create a huge amount of excitement (and profits) on a new MS drug that had a radically different dosing and efficacy than what is already on the market. This will not be lost on the myriad other drug companies out there.
Tysabri, if nothing else, showed that it was possible to create a huge amount of excitement (and profits) on a new MS drug that had a radically different dosing and efficacy than what is already on the market. This will not be lost on the myriad other drug companies out there.
Disclaimer: Any information you find on this site should not be considered medical advice. All decisions should be made with the consent of your doctor, otherwise you are at your own risk.
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HarryZ
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Flora,
As for my feelings on Biogen....I center them out more because of what I have been told from three separate sources on how they operate. And that is pretty much without any kind of ethics!!
As for Teva and Serono....pretty much in the same mold. I know that Teva pays Dr. C. Smith, a MS neurologist in the Seattle area, as an official spokesperson for them. I have heard comments on how he operates in this capacity and it's a dog-eat-dog world when it comes to the competition among these companies.
And yes, the pharmaceutical companies are in business for one reason and one reason only....and that is to make as much money as possible. Now there is nothing wrong with that attitude in the business world but when it comes to drugs and human health, you would think that a level of ethics would surface in there somewhere. But not a chance and we've just seen what happened with the Biogen/Tysabri situation.
Months earlier Biogen publicly made available a summary of their Tysabri marketing plan which gave market share projections and the fact that they expected to take over a huge slice of the MS drug world. And this was done quite some time before the Phase III trials ended. There was one and only one reason to do this and that was to create a "feeding frenzy" in the stock market to increase revenue by huge amounts even before the drug was approved by the FDA. And it worked well. Biogen's stock went up quickly and they continued to issue press releases at how great Tysabri was going to be. And all this time they obviously were aware of the safety issues.
I was told months ago by more than one person in MS medicine that there were concerns about Tysabri. But names and sources could not be given for a variety of reasons and when I mentioned bits and pieces about these concerns, some people really went after me for daring to make such statements. I must admit that even I started to wonder about the information that I was being given because of the constant barrage of Biogen press releases indicating how good Tysabri really was. Well, we all know differently now and there are a lot of MS patients who are terribly disappointed at this news. Perhaps Biogen may be able to straighten this mess out over time but in the meantime their trust level and stock has dropped tremendously.
Take care.
Harry
Your description of drug salespeople is right on and I couldn't help but chuckle as I read your note. Marg dealt with these people all through her nursing career in the hospitals because she was a manager and had little or no respect for most of them.Harry, do you know of any particular reason to believe that Biogen/Elan is, well, more ethically-challenged than, say, the other MS drug makers like TEVA? Or major manufacturers of other meds as in Merck or Bayer?
As for my feelings on Biogen....I center them out more because of what I have been told from three separate sources on how they operate. And that is pretty much without any kind of ethics!!
As for Teva and Serono....pretty much in the same mold. I know that Teva pays Dr. C. Smith, a MS neurologist in the Seattle area, as an official spokesperson for them. I have heard comments on how he operates in this capacity and it's a dog-eat-dog world when it comes to the competition among these companies.
And yes, the pharmaceutical companies are in business for one reason and one reason only....and that is to make as much money as possible. Now there is nothing wrong with that attitude in the business world but when it comes to drugs and human health, you would think that a level of ethics would surface in there somewhere. But not a chance and we've just seen what happened with the Biogen/Tysabri situation.
Months earlier Biogen publicly made available a summary of their Tysabri marketing plan which gave market share projections and the fact that they expected to take over a huge slice of the MS drug world. And this was done quite some time before the Phase III trials ended. There was one and only one reason to do this and that was to create a "feeding frenzy" in the stock market to increase revenue by huge amounts even before the drug was approved by the FDA. And it worked well. Biogen's stock went up quickly and they continued to issue press releases at how great Tysabri was going to be. And all this time they obviously were aware of the safety issues.
I was told months ago by more than one person in MS medicine that there were concerns about Tysabri. But names and sources could not be given for a variety of reasons and when I mentioned bits and pieces about these concerns, some people really went after me for daring to make such statements. I must admit that even I started to wonder about the information that I was being given because of the constant barrage of Biogen press releases indicating how good Tysabri really was. Well, we all know differently now and there are a lot of MS patients who are terribly disappointed at this news. Perhaps Biogen may be able to straighten this mess out over time but in the meantime their trust level and stock has dropped tremendously.
Take care.
Harry
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HarryZ
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Amelia,
I can honestly say that I know the pain that you feel when caring for your husband and watching him slide. Marg's MS progressed to SPMS in 1996 and if it wasn't for the Prokarin that she takes, I'm sure she would be in a nursing care home now. She fell and broke her leg in 2001 and that has only complicated the situation.
I would only hope that you have some support mechanisms to get you through the worst times because trying to do it all by yourself is an immense if not impossible task.
If you ever need any assistance please email at hzanin@rogers.com and I'll try and help.
Harry
I can honestly say that I know the pain that you feel when caring for your husband and watching him slide. Marg's MS progressed to SPMS in 1996 and if it wasn't for the Prokarin that she takes, I'm sure she would be in a nursing care home now. She fell and broke her leg in 2001 and that has only complicated the situation.
I would only hope that you have some support mechanisms to get you through the worst times because trying to do it all by yourself is an immense if not impossible task.
If you ever need any assistance please email at hzanin@rogers.com and I'll try and help.
Harry