EMail to FDA/AC ie TEVA

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

EMail to FDA/AC ie TEVA

Postby better2gether » Tue Feb 28, 2006 11:32 pm

.
I found this interesting post today on an messageboard.

" EMail to FDA/AC ie TEVA

by: uvauncduke 02/28/06 - This post has 86 recommendations

Dear Dr. Mosaddeghs:

I understand you represent CDER/FDA in the upcoming Peripheral and Central Nervous System Drugs Advisory Committee meeting regarding the multiple sclerosis drug Tysabri scheduled for March 7th and 8th.

As a physician I have both professional and personal contacts with patients stricken with multiple sclerosis. I greatly respect the monumental task the FDA/CDER has in assessing risk/benefit for all drugs. I also am aware of the highest integrity by the FDA in putting the best interests of the patients first and foremost.

Were this the only battleground for Tysabri I would not be writing and taking your time.
Unfortunately there are competitors of Tysabri that appear to function in a 'business environment' that does not place the same standards of 'patient first'. This was evident today when TEVA Pharmaceutical (competitor and maker of MS drug of Copaxone and associated with Rebif (SRA)) released an inaccurate and highly prejudicial article comparing the immunosuppressive characteristics of Tysabri with AIDS.


Tysabri Suppresses Immune System as Much as HIV, Study Finds
2006-02-28 13:50 (New York)

By Angela Zimm
Feb. 28 (Bloomberg) -- Biogen Idec Inc. and Elan Corp.'s
Tysabri, the multiple-sclerosis drug withdrawn because of its
ties to a fatal brain infection, can deplete immune-system cells
as much as HIV, researchers found.
The amount of immune-system cells in spinal fluid of
patients given Tysabri fell as low as levels seen in people
infected with the virus that causes AIDS, ...

... "Teva Pharmaceutical Industries Ltd., the maker of the
multiple-sclerosis drug Copaxone, circulated copies of the
abstract yesterday to the media through an outside spokesman,
Peter Steinerman in New York.
George Barrett, chief executive officer of Teva North
America, was not immediately available for comment, Steinerman
said. "

This was written by a virologist extremely knowledgable about tysabri...

"I feel bad for anyone who got ripped off by TEVA and their actions - lymphocytes in the CSF are indicators of infection or inflammation - normal CSF has 0-5 WBC - reducing the numbers of WBC in the CSF is indicative of a treatment that is working
lymphocytes in the CSF are not protective - and having zero lymphocytes in your CSF is not a marker of disease - it is normal
I think TEVA and the investigators on this study need to be censored"


I know several members of the AC have signed waiver of conflict of interest but as they are paid consultants by this very same TEVA I would hope that this despicable behavior by TEVA is recognized by all committee members. I DO NOT question the integrity of the committee and recognize all members maintain the highest professional and ethical standards as well as expertise in their fields. TEVA appears to be putting 'business' ahead of multiple sclerosis patient's interest. As long as the committee is aware of this I am confident that the multiple sclerosis patients interests will be protected fully by the FDA/CDER.
Thank you this forum to express my concerns.
Appreciatively,

XXX XXXXXXX M.D. "
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Postby HarryZ » Wed Mar 01, 2006 6:39 am

Isn't it nice to know that the big pharmas to whom we entrust the development of MS medications, place the patient first above all else!!!

If Tysabri was a competitor's drug, I'm sure that Biogen/Elan would be doing exactly the same thing.

And here's another article that was published about Tysabri...

<shortened url>


The FDA hearing$ on Ty$abri will be a "battlefield" for big pharma.

Harry
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Postby Bucks » Wed Mar 01, 2006 10:20 am

hmm, but the Teva fear mongering isn't much different than that on this board. :P

Bucks,

After reading this latest article[AAN Abstract re: PML], I think I would be far more concerned about long term Tysabri use than EDSS differentials!

######


One of the NEJM articles claimed to be coming tonight reviews the PML issue. Let's see how they quantify the risks.
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Postby HarryZ » Wed Mar 01, 2006 12:08 pm

Bucks wrote:hmm, but the Teva fear mongering isn't much different than that on this board. :P


Except that Teva is using "scientists" to state their concerns!! Kind of makes you wonder whether potential revenue outweighs scientific accuracy when Tysabari is involved. Then are we supposed to believe what Biogen/Elan has been telling us all along about how good Tysabri is!!??

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Postby better2gether » Thu Mar 02, 2006 3:03 am

Tysabri: As Bad as AIDS?

By Bill Mann (TMF Otter)
March 1, 2006

Elan (NYSE: ELN) shareholders are a certifiably nervous lot these days. In a week, the Food and Drug Administration will hold hearings on whether -- and under what circumstances -- it will allow Tysabri, a treatment for multiple sclerosis that Elan developed and co-markets with Biogen IDEC (Nasdaq: BIIB), to return to the market. When the two companies voluntarily pulled the drug following reports linking it to two deaths from progressive multifocal leukoencephaly (mercifully abbreviated PML) last year, Elan's share price tanked by more than 70%. When another case came to light -- this time with a patient taking Tysabri as a monotherapy -- the losses from the peak increased to 90%.

Elan seemed cooked. Tysabri was its great hope. But there was no denying a few things: Tysabri was more effective in treating MS than anything else on the market, the two cases of PML presented themselves in patients who were using Tysabri in combination with other drugs, and MS sufferers and many neurologists alike were clamoring for its return to the market. In November, the FDA put Tysabri on priority review, and next week, they'll hold the meeting. To say that a lot rides on the outcome of this meeting for Elan shareholders is an understatement. The stock has risen 300% from its April lows, but recent weakness in the shares suggests that some shareholders are hedging their bets or are selling entirely.

So when, on Feb. 28, a University of Texas report stated that Tysabri can deplete immune-system cells by the same level as the HIV virus, Elan shares went into a complete tailspin, dropping more than 14% before recovering to finish down only 7% at the close.

However, Bloomberg said on Wednesday that this report, which has yet to be accepted by a medical journal, was circulated by a spokesman for rival MS drugmaker Teva Pharmaceutical (Nasdaq: TEVA). If this is true, I believe it's a pretty dastardly deed -- not so much because a study showing that Tysabri lowers the immune system as much as HIV does is slanderous, but because doing so shows that Teva is willing to try to influence proceedings before the FDA meeting by introducing additional doubt for the safety of Tysabri. It also shows that the company considers the drug to be a legitimate threat to its own MS treatment, Copaxone.

Let's face it -- HIV is scary, a true hot button if there ever was one. But the report doesn't say that Tysabri is as dangerous as HIV. It says that it lowers immune systems to similar levels. Well, hello! Tysabri is an immunosuppressant. This is how the drug combats MS. Essentially, Tysabri sequesters the immune system to keep it from destroying the central nervous system. The challenge is to keep the immune system from dropping too low. This, incidentally, is why most PML cases exist in people who have full-blown AIDS. The virus that causes PML exists in an estimated 70% of the general population, but remains latent.

Now, imagine that -- an immunosuppressant that suppresses the immune system! None of this implies that suppressing the immune system isn't an extremely dangerous thing to do. But it also happens to be the most effective way to treat a debilitating and deadly disease.

This is not to cast aspersions on the original Texas research, which may turn out to be bulletproof. But Tysabri is a drug administered once a month by doctors, who, one would assume, observe and adjust dosing as needed. But while the study may have its clinical use in helping make Tysabri (and future MS treatments) safer, the link to HIV in the public domain is spurious. You might as well say that helium is as dangerous as hydrogen because it also makes balloons float.

Makes you wonder why Teva's representative went to such an effort to make the study known, doesn't it?

<shortened url>
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Postby johnrob » Thu Mar 02, 2006 7:13 am

HarryZ wrote:
Bucks wrote:hmm, but the Teva fear mongering isn't much different than that on this board. :P


Except that Teva is using "scientists" to state their concerns!! Kind of makes you wonder whether potential revenue outweighs scientific accuracy when Tysabari is involved. Then are we supposed to believe what Biogen/Elan has been telling us all along about how good Tysabri is!!??

Harry


Let's face it - All the pharma's are concerned about revenue period... Kinda like an "expert" testifing at trial... The defense wants one who will support innocence (instill reasonable doubt) and the prosecution wants one who will slam dunk a conviction. Biogen jumped on the Tysabri bandwagon for a reason... My opinion and others is that they didn't want to lose market share. Even went as far as funding a trial "pairing" Avonex with Tysabri... Greed is what is to blame here. I could have greatly benefited from the med. - but I sit here and wait while the "so called" experts duke it out. In the mean time this so called "unbiased MS community" site is making up stats to scare people. As stated on the main page "1-1000 chance of contracting PML" - what scientist/expert came up with that number??? Maybe this site is funded by TEVA?
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Postby HarryZ » Thu Mar 02, 2006 7:34 am

Johnrob,

In the mean time this so called "unbiased MS community" site is making up stats to scare people. As stated on the main page "1-1000 chance of contracting PML" - what scientist/expert came up with that number??? Maybe this site is funded by TEVA?


This site hasn't been "making up" stats to scare people. These numbers are taken from trials/studies/press releases and posted in various threads. The scare tactics are coming from the pharmaceutical companies who develop the MS drugs and then will do and say almost anything to keep or increase their market share. The MS drug world is worth billions of dollars and that is the goal of these companies. The plight of MS patients is quite secondary to these companies. One only needs to follow the Tysabri adventure for the past couple of years to see this.

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Postby johnrob » Thu Mar 02, 2006 8:29 am

HarryZ wrote:Johnrob,

In the mean time this so called "unbiased MS community" site is making up stats to scare people. As stated on the main page "1-1000 chance of contracting PML" - what scientist/expert came up with that number??? Maybe this site is funded by TEVA?


This site hasn't been "making up" stats to scare people. These numbers are taken from trials/studies/press releases and posted in various threads. The scare tactics are coming from the pharmaceutical companies who develop the MS drugs and then will do and say almost anything to keep or increase their market share. The MS drug world is worth billions of dollars and that is the goal of these companies. The plight of MS patients is quite secondary to these companies. One only needs to follow the Tysabri adventure for the past couple of years to see this.

Harry



Taking anything out of the original context is dangerous and biased if you ask me.... Maybe the scientist(s) who discovered the monocloal antibodies way back in the 70's were in on the big $ conspiracy.
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Postby HarryZ » Thu Mar 02, 2006 10:13 am

Johrob,

anything out of the original context is dangerous and biased if you ask me.... Maybe the scientist(s) who discovered the monocloal antibodies way back in the 70's were in on the big $ conspiracy.


If that is the case then everyone here or on any other MS Forum should just copy and paste articles as they read them and offer no discussion or opinions!! We should read what the drug companies tell us and not question anything! Do exactly as the doctor says and don't you dare question what he/she has told you!! What century are you living in, Johnrob?

The whole idea here is to exchange information, offer opinions and stimulate thought. I believe that is what learning is all about. Not everyone agrees with certain points of view....and I should know more than anyone :)

As for the scientists who discover new drugs, etc.....that's their job. What the drug companies do with these discoveries is another matter!

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Postby bromley » Thu Mar 02, 2006 11:36 am

Harry,

I'm starting to worry about your health.

I want you to go to your doctor and get your heart and blood presure checked. I can't see you lasting beyond the FDA announcement at this rate. You must be in Tysabri heaven.

Are you hoping they re-approve or not approve? If the latter, then you'll have nothing to do. I bet you'll turn your attention to Dacluzimab. It's another Biogen product.

You should also go to confession on Sunday as I thought you said you were giving up posting on Tysabri for Lent.

Ian
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Postby HarryZ » Thu Mar 02, 2006 12:23 pm

Ian,

bromley wrote:Harry,

I'm starting to worry about your health.


Not to worry....couldn't be feeling better :D

I want you to go to your doctor and get your heart and blood presure checked. I can't see you lasting beyond the FDA announcement at this rate. You must be in Tysabri heaven.


Don't think I'll have a problem with the FDA announcement, regardless of what way it goes. Now, if I were a Biogen/Elan stockholder, I think I might be getting a little nervous, especially since Biogen/Elan's competitors have brought out their heavy guns and are shooting wildly!!

Are you hoping they re-approve or not approve? If the latter, then you'll have nothing to do. I bet you'll turn your attention to Dacluzimab. It's another Biogen product.


Good question, Ian. You know, it won't effect me one way or the other. I've been saying for months that the FDA will re-approve Ty$abri because there is simply too much money at issue here and in the end, money almost always wins. What concerns me more than anything is the huge marketing battle that has begun among the competition and we have already seen the opening salvo by Teva. It's likely to get much worse before it gets better. More money being spent on fighting with one another.....wouldn't it be nice if that money could be used for helping MS patients cope easier with the disease?

Now Dacluzimab...a friend of ours is in the clinical trial here at the MS Clinic. She's had a significant problem but I don't know if it has to do with the drug or not....waiting to hear if she will continue in the trial or be forced to drop out.

You should also go to confession on Sunday as I thought you said you were giving up posting on Tysabri for Lent.


And deprive so many of interesting posts??!!! Not a chance, regardless of what Father O'Malley may say to me :D

Take care.

Harry
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Postby johnrob » Thu Mar 02, 2006 12:37 pm

HarryZ wrote:Johrob,

anything out of the original context is dangerous and biased if you ask me.... Maybe the scientist(s) who discovered the monocloal antibodies way back in the 70's were in on the big $ conspiracy.


If that is the case then everyone here or on any other MS Forum should just copy and paste articles as they read them and offer no discussion or opinions!! We should read what the drug companies tell us and not question anything! Do exactly as the doctor says and don't you dare question what he/she has told you!! What century are you living in, Johnrob?

The whole idea here is to exchange information, offer opinions and stimulate thought. I believe that is what learning is all about. Not everyone agrees with certain points of view....and I should know more than anyone :)

As for the scientists who discover new drugs, etc.....that's their job. What the drug companies do with these discoveries is another matter!

Harry



Posting "partial" information is simply a way to sway folks into believing a certain perspective. If you are well versed and try to disseminate technical/medical information into layman’s terms - that's great. But, no matter which century one is from, folks have and will continue to do this simply because they have a vested interest. I don't think posting "quotes" of hundred word abstracts does anybody any good. Some have a "hidden" agenda... I don't - I only want to stop my central nervous system from deteriorating - and if Tysabri is a temporary stop gap measure to a cure then I should have access to it... Quite frankly, I'm thankful that someone is researching - whether or not they cash in... We "should" question, but not to the extreme or to the extent when something is threatening their "vested" interest.... My job Harry, is to continue living a reasonable quality of life which enables my continued employment.. I have children to take care of and I want every shot of continuing to do just that.

-John
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Postby Arron » Thu Mar 02, 2006 12:48 pm

John,
In the mean time this so called "unbiased MS community" site is making up stats to scare people. As stated on the main page "1-1000 chance of contracting PML" - what scientist/expert came up with that number??? Maybe this site is funded by TEVA?


Please see:

http://content.nejm.org/cgi/content/short/354/9/924

Conclusions A detailed review of possible cases of PML in patients exposed to natalizumab found no new cases and suggested a risk of PML of roughly 1 in 1000 patients treated with natalizumab for a mean of 17.9 months. The risk associated with longer treatment is not known.



John, these statistics come from the study abstracts published in the New England Journal of Medicine. This site is not funded by any company, Teva or otherwise. I understand your frustration, but I would like you to please stop making unfounded accusations against us. If you look through our archives, you will see that This is MS published an article highly critical of the implications of the third PML case discovery precisely when the public/media bandwagon was turning AGAINST all things Tysabri. We are interested in the truth and the betterment of the MS community, whatever format that takes.


Thanks,
-a
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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Postby johnrob » Thu Mar 02, 2006 1:47 pm

Arron wrote:John,
In the mean time this so called "unbiased MS community" site is making up stats to scare people. As stated on the main page "1-1000 chance of contracting PML" - what scientist/expert came up with that number??? Maybe this site is funded by TEVA?


Please see:

http://content.nejm.org/cgi/content/short/354/9/924

Conclusions A detailed review of possible cases of PML in patients exposed to natalizumab found no new cases and suggested a risk of PML of roughly 1 in 1000 patients treated with natalizumab for a mean of 17.9 months. The risk associated with longer treatment is not known.



John, these statistics come from the study abstracts published in the New England Journal of Medicine. This site is not funded by any company, Teva or otherwise. I understand your frustration, but I would like you to please stop making unfounded accusations against us. If you look through our archives, you will see that This is MS published an article highly critical of the implications of the third PML case discovery precisely when the public/media bandwagon was turning AGAINST all things Tysabri. We are interested in the truth and the betterment of the MS community, whatever format that takes.


Thanks,
-a



- Your words directly from the main page -

In short, Tysabri continued to demonstrate strong efficacy in terms of disability progression and relapses, a relatively low side effect profile, and (hold your breath)-- a risk of PML that has been preliminarily quantified as approximately 1 in 1000, when a person is given nearly 18 months of exposure to Tysabri. This data is of course artificially limited due to the clinical trials being halted last year; the true number can only be known in time.



The "suggested risk" - "hold your breath" - does not take into consideration mono threapy or combined therapy - meaning an already suppressed immune system or not.. Which to me is totally misleading...

You are quoting a "tiny" excerpt of a teaser of an abstract. You should note a disclaimer when you do that... Quite misleading for an "UNbiased" site. As far as the Teva comment is concerned - It was a joke... Now if you were promoting Google.. I could completely understand because they pay you for the ad space / traffic.... One mans unfounded accusations are another mans opinion.

I realize and agree that thisisms.com - is a great place for MS info. but I disagree totally with misleading / sensationalizing information. In my opinion thats what the newspaper and Nightly news is for - isn't it.

Then again what do I care?
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Postby HarryZ » Thu Mar 02, 2006 2:38 pm

Jphnrob,

Posting "partial" information is simply a way to sway folks into believing a certain perspective.


I certainly will agree with you to a certain extent on this but isn't that exactly what some drug companies do when it comes to posting data on clinical trials? (such as what we have read about Tysabri so far). That is why you will hear many researchers in this field state that they want to see the entire trial published on any one drug so it can be "peer reviewed". We haven't seen this done yet with Tysabri and that is but one reason for my constant criticism about how Biogen/Elan has handled this medication. We have already had conditional approval of Tysabri and this process was not done! It's what we may not know about it that concerns me.

If you are well versed and try to disseminate technical/medical information into layman’s terms - that's great. But, no matter which century one is from, folks have and will continue to do this simply because they have a vested interest. I don't think posting "quotes" of hundred word abstracts does anybody any good. Some have a "hidden" agenda.


I won't speak for others here but there are some very talented participants on this forum who communicate at a level much higher than many of the other MS forums that I visit. They simply don't accept any one person's point of view and go into a lot of effort to challenge what may have been written. Some of it is indeed difficult to follow but then that is the nature of this forum. I don't think these people have any kind of hidden agenda but are interested in looking very deeply into the MS world. If one wants simple and basic information that goes unchallenged then there are a number of forums that operate on that level.


I don't - I only want to stop my central nervous system from deteriorating - and if Tysabri is a temporary stop gap measure to a cure then I should have access to it... Quite frankly, I'm thankful that someone is researching - whether or not they cash in... We "should" question, but not to the extreme or to the extent when something is threatening their "vested" interest.... My job Harry, is to continue living a reasonable quality of life which enables my continued employment.. I have children to take care of and I want every shot of continuing to do just that.


I won't dispute your desire for doing anything it takes to help your nervous system, whether that involves using Tysabri or not. But if a drug is to be accessible to the public, then there are certain standards that are set by the FDA that MUST be followed. Biogen/Elan tried to stick handle through these standards too quickly and paid the price of getting caught when PML showed up. Now they have to back-track to try and get it right and as usual, it's the MS patient who has to wait and wait.


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