View on Tysabri

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

View on Tysabri

Postby bromley » Thu Oct 27, 2005 9:08 am

The NMSS website includes the following request to provide views on Tysabri to the FDA.

The request is odd as it assumes we know what the risks / benefits are. The current CRAB treatments are modest at best so we are all after better treatments but who knows how much better Tysabri is (apart from the trials data and some feedback from some users)!


http://www.nationalmssociety.org/news_tysabri.asp


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Re: View on Tysabri

Postby HarryZ » Fri Oct 28, 2005 6:19 am

Ian,

The request is odd as it assumes we know what the risks / benefits are. The current CRAB treatments are modest at best so we are all after better treatments but who knows how much better Tysabri is (apart from the trials data and some feedback from some users)!



Sounds like this is more of a political/marketing kind of scheme created by Biogen/Elan and the NMSS! I find it interesting that they refer readers to the press release by Biogen/Elan in order to learn of the safety information on Tysabri. Now there's a 100% reliable source!!!!

What the FDA is likely to get is a lot of requests by MS patients who demand that Tysabri be made available. Of course those requests won't be made on reliable scientific information because we don't have that info available as yet. Not even the researchers have the answers at this time.

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Postby MetsFan » Fri Oct 28, 2005 9:43 am

Once again, Harry is spouting unfounded assertions.

Neither the NMSS or Biogen/Elan came up with the idea of canvassing patients. It was the FDA. How do I know? Because the FDA was talking about this as far back as May 2005:

after putting in the link, type "Throckmorton" and "Tysabri" in the search box:
http://www.thepinksheet.com/fdcreports/ ... tSearch.do

Unfortunately, the article is only available by subscription. However, the article says that The Director of the Center for Drug Evaluation & Research (CDER), Douglas Throckmorton, indicated that once a full analysis of the Tysabri safety database is completed, FDA plans to rely on patient groups to help decide the appropriate risk/benefit trade-off for Tysabri.

Now that the safety review is complete, it is clear that Throckmorton asked the NMSS to canvas its members. What was the NMSS to do? Tell them to screw off?

(If you want to get a feel for how the NMSS feels about the return of Tysabri, take a look at the first sentence of the article requesting input: "Do you feel that Tysabri (natalizumab, sponsored by Biogen Idec and Elan Corporation) is too dangerous to return to the market?" If Harry bothered to speak with the NMSS brass, he would find he has lots of support for his position.)

It is my view that it is outrageous for the FDA to canvas patients about the risk/benefit of a drug. I want a government agency that is willing to make hard choices, not pass on the important decisions by designing a poll. In the post-Vioxx world, the FDA is scared of its own shadow and is now incapable of doing what it believes is the best course of action based on the available evidence.

It is also my view that Harry has a legitimate point of view and an excellent writing style. But in his mania to blame Biogen for everything short of Hurricane Katrina, he is incredibly sloppy with his facts.
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Postby HarryZ » Mon Nov 07, 2005 2:17 pm

Metsfan,

MetsFan wrote:Once again, Harry is spouting unfounded assertions.


Well, let's look at the situation.

Biogen/Elan have asked the FDA to speed up the review process. They want a decision as quickly as possible because the revenue ramifications of a speedy, positive review are immense. Biogen/Elan continue to create press releases stating how safe Tysabri is and how much MS patients want it to return.

The NMSS suggests people let the FDA know their feelings on Tysabri. The background of info on Tysabri is a link to a release by Biogen/Elan. The NMSS points out that:

"One of the roles of the FDA's Office of Special Health Issues is to serve as a channel through which patient issues and viewpoints can be brought to the attention of FDA medical and regulatory staff."

So you say that it's outrageous that the FDA solicit comments from MS patients....then why would they have this special office?!!

Now I would think that if patients were to give a viewpoint on Tysabri, the patients should be able to read an independent safety review of the drug. But the only info we continue to see in print is what Biogen/Elan has been telling us. There is no independent review available to the public and the medical comments that I continue to read from various articles is that nobody seems to know just how Tysabri and PML relate to one another.

And Biogen/Elan continue to make comments in the financial world that they expect Tysabri to return. And there is only one purpose for this....up the stock price.

Now if you think that Biogen/Elan isn't behind this whole process....well, you can certainly have that opinion but in following these companies for the past few years I will stand by my original comment. Biogen/Elan are lobbying the FDA bigtime in regards to Tysabri because this drug is of huge importance to them.....especially Elan. It could mean their very survival.


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Postby OddDuck » Tue Nov 08, 2005 5:42 am

Well, I'm glad I heard about this "survey" the FDA is doing.

This isn't going to make anybody happy, I'm sure, (Biogen least of all) but I wrote to them just now. And I reminded them how they ignored me the first time, and as a result, people died, and my very warnings and findings are now being used in court action against Biogen.

Go figure, huh? Let's see if they ignore me this time.

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Postby HarryZ » Tue Nov 08, 2005 7:42 am

Deb,

I'm wondering if Biogen is not too concerned about the FDA survey.

From a scientific perspective, Biogen pretty much ignored the warnings that they got about Tysabri, yours included. They will have to answer to that in the Anita Smith litigation.

From a general user view, I have read many messages on various MS forums from previous Tysabri patients that they want the drug back, regardless of the risk. These patients indicated that their docs had the same point of view. These people have been told to write the FDA and express their opinions.

I'm going to guess that the FDA is going to get far more messages from those who want Tysabri back as opposed to those who want a very cautious approach to the drug. While their scientific rationale may not be sound, their numbers may be. I don't know what kind of weight the FDA places on these comments versus a more scientific, cautionary comment. The very fact that the FDA has an office that deals with this indicates to me that they are sensitive to public opinion. Demands to bring the drug back by the public are likely to be higher than those who don't share that opinion and I'm sure that Biogen's marketing people may have that same thought.

Oh to be a fly on the wall in the FDA :-)))

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Postby poetriri » Sat Nov 12, 2005 2:49 pm

I am curious to know if any of you 'naysayers' to Tysabri have experienced the drug itself. I am also curious to know if any of you have followed the New England Journal of Medicine's articles that give insight into the safety evaluations. I had 2 doses of Tysabri and was able to go from using my walker to using a cane...and going out into the community on my own unassisted.
For me the whole Tysabri issue becomes a patient choice issue. There have been ABSOLUTELY ZERO issues with Tysabri given to patients as a monotherapy. All of the PML cases were with severly immuno compromised folks taking more than one immuno modulating therapy. There is also new investigation being conducted as to whether or not one of the Tysabri alleged PML cases was even an MS patient...or was she misdiagnosed to begin with.
There is plenty of good scientific information available through medical journals and also through the FDA.
I can't wait to get back on my Tysabri so that I may be lucky enough to be in the company of my friend who received it for 3 years in trials. Her words of wisdom to me "i forgot I had MS".
We each need to be allowed to choose what kind of risks we are willing to take. As my MS declines and I watch my 2 year old son's life passing by...damn right I will take my risk for a better quality of life.
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Postby HarryZ » Sat Nov 12, 2005 9:03 pm

Heather,

One doesn't have to take Tysabri in order to comment on the drug. After all, none of the researchers, docs nor Biogen sales reps take Tysabri and they have lots to say about it.

If one has followed the drug in the past couple of years it's not so much the drug that is being criticized as opposed to Biogen/Elan's manner in how they have introduced it into the MS market. Simply put, it was rushed into use with MS patients because of the huge revenue potential that came with it.

When you say that there has been "zero" issues with Tysabri as a monotherapy you unfortunately are not correct. A number of users had serious infections associated with its use and this was information that a reporter had to obtain under the freedom of information act. Biogen/Elan certainly did not make it public. And nobody yet knows the association of Tysabri and PML because not enough is understood about that as yet.

I agree with you that patients should have the choice of using Tysabri or any drug after being totally informed about it but how can the patient be properly informed about Tysabri when the docs are divided on just how safe the drug may or may not be. Some docs tell their patients that they can't wait until Tysabri is re-approved while others say that they won't use it because not enough is known about it!

I believe the drug will be brought back but used under very strict guidelines and certainly not given to patients who have used other immune suppressing drugs recently. And they are going to have to find a way to monitor Tysabri users very carefully and watch for signs of PML.

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Can you sight any data?

Postby poetriri » Mon Nov 14, 2005 9:26 am

Harry
I would love to have you state your sources on the opportunistic infections data you shared. It seems you are just relating info from a non expert media reporter and it is fact that they have gotten most of the data wrong over the past 7-8 months. The fact is that opportunistic infection in the placebo control group was nearly equal to the
AFFIRM monotherapy trial group. Have you actually read the trials data or are you being misled by the media?
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Re: Can you sight any data?

Postby HarryZ » Mon Nov 14, 2005 11:40 am

Heather,

I would love to have you state your sources on the opportunistic infections data you shared. It seems you are just relating info from a non expert media reporter and it is fact that they have gotten most of the data wrong over the past 7-8 months. The fact is that opportunistic infection in the placebo control group was nearly equal to the
AFFIRM monotherapy trial group. Have you actually read the trials data or are you being misled by the media?
Heather


Most of the information that comes our way re: Tysabri these days is from articles that involve the financial world. Just read Biogen/Elan's press releases and you can see that they are geared toward the stock market. At the same time news reporters and financial analysts are always looking for information about Tysabri and these companies because of the impact it all has in the financial world. After all, when Tysabri got pulled off the market in February, the Biogen/Elan stock lost $ 17 billion overnight so it doesn't take a rocket scientist to understand why Biogen/Elan are being looked at so closely. A lot of people lost a lot of money....unless of course, you were the privileged few Biogen execs who made millions by selling their stock just before the withdrawal of Tysabri!!

Here is one source of the information that I read but there were others...

"This is the WSJ article (by Sylvia Pagan Westphal) now. Here's the gist:

Stephen Harr, a Morgan Stanley analyst, prepared a note based on adverse-event (AE) reports submitted to FDA, which the analyst obtained by a request under the Freedom of Information Act. In addition to the already-publicized fatalities from progressive multifocal leukoencephalopathy (PML), Harr noted the AE file documented 7 additional fatalities among Tysabri patients. One was attributed to pneumocystis pneumonia, another to herpes encephalitis, and four others to sepsis. The Tysabri AE file also documented "numerous" nonfatal infections.

Biogen, who markets the drug with Elan, has downplayed the significance of the data in the AE file. A Biogen spokesman said a Biogen/Elan analysis found no statistically significant differences in serious adverse events between Tysabri and a placebo in several clinical trials.

FDA has declined to comment."

Now the readers can choose to believe this reporter or not but why on earth would she go to the trouble of obtaining this info through the Freedom of Information route and then falsify what she discovered. Do you think for one minute that Biogen/Elan would publicly publish this info? Drug companies simply don't make available detrimental info about their products and for very good reason.....it doesn't exactly do sales much good!!!

Also, readers can choose to believe everything that Biogen/Elan provides us. I simply am not one of those readers and have been told by more than one person in medicine that Biogen is not reliable or to be trusted. And how they introduced Tysabri into the MS market certainly hasn't changed my opinion of them.

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HarryZ, front and center.

Postby TheTysabriBull » Tue Nov 15, 2005 7:13 pm

In your own 100 words or less can you roughly describe to our audience the overall safety and efficacy of all available MS drugs prescribed within the MS population in the last 12 years with exception of Tysabri which is currently unavailable? Please identify which of the currently available MS drugs or therapies have already been directly linked to PML infection with exception of IM beta interferon 1a/Tysabri combo in the Sentinel clinical study? If PML is already known to rarely spontaneously occur in the treatment naive human population prior to the availability of natalizumab what would be the odds of PML having occurred in the previously treated MSer population and be incorrectly parallel diagnosed as an MS relapse resulting in patient death? Is is possible that a certain small fraction of currently diagnosed MSers are actually not specifically MSers but victims of another type of slowly advancing, demyelinating disease?


When you are done with all that that please tell us why you are so compulsively content in denying and refuting another human being their right to make a well informed decision and choice in pursuit of a higher quaility of life as an MSer?


Thanks in advance for making it perfectly clear to us fully vested MSers that you have had little to say at all in encouraging support of any new or better choice in spite of you fortunately being a non-MSer.
21+ year Veteran MSer, 10 Year ABCR junkie, and one lucky guy who is experiencing the magical wonders of Tysabri for MS. I maybe totally blind in one eye but, I can sure see straighter out of the other.
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Re: HarryZ, front and center.

Postby HarryZ » Tue Nov 15, 2005 8:56 pm

Hi there "Bull",

The answer to your first paragraph is quite simple..."unknown" for most of the questions.

Your second paragraph question has no basis since almost every person on this forum supports and encourages MS patients to make their own decisions on their treatment.....as long as the info they use to make their decision is properly given to them and is correct.

As for your third paragraph comment....treatments for MS, whether they are old or new, have to earn that support in the world of science. Fancy marketing with the promises of good health isn't my idea of helping MS patients. It may be great for the bottom line of a company's ledger but doesn't do much to help a MS patient's quality of life.

Take a look at the new thread that comes from UCLA researchers describing demyelination beginning in the young years of human development. Toxins and diet are thought to start demyelination and these researchers are suggesting that more work be done in the metabolism aspect of the brain as opposed to the neuropathic line that has been done for years. Perhaps you then might start to understand why the current MS therapies haven't done much of anything to stop this lousy disease. Fifty years of MS research and where are we....no known cause and certainly nothing remotely close to a cure.

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Hello Harry

Postby TheTysabriBull » Tue Nov 15, 2005 10:08 pm

I have to agree to disagree with you on one of your comments. The mechanism of action of natalizumab therapy comes much closer to mitigating the precursory inflammatory stage of MS than any of the existing therapies do today. More accurate targeting of the soluble VCAM molecules with the exclusive Tcell responder's VLA4 that were once capable of more easily migrating or cascading across the endothelial wall and into the target myelin tissue might be closer to a cure than many of us give it any credit for.

Granted, part of the autoimmune defense system for the infused Tysabri patient maybe blocked from entering various organs of the body but the fact remains that inherently a bug or virus must either be in that area prior to therapy or that bug or virus must have either leaked thru after therapy for any infection to occur.

With the previous very large size of the clinical trials and the relative low frequency occurance of few opportunistic infections in the AFFIRM trial it maybe that the safety afforded a monotherapy Tysabri patient might be much better than any of the less informed detractors want us to believe.

Please remember that Tysabri is also a serious business threat to most all of the existing 1st generation MS therapies of yesterday.


By the way Harry, I sadly know of 3 MSers who have committed suicide because of their sudden loss of hope after Tysabri was suspended. What a terrible shame.


Take care Harry
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Postby bromley » Wed Nov 16, 2005 3:21 am

TysabriBull,

I sadly know of 3 MSers who have committed suicide because of their sudden loss of hope after Tysabri was suspended


That's very sad but shows how much those with this disease pin their hopes on better treatments and how much we have been let down by the medical profession (neurology). At the end of the day we have a disease where there is no cure, it is progressive, and it affects all parts of the body (or can). One only has to see pictures of Richard Pryor to see how vile this disease can be. That is why the risk issue with MS drugs is almost irrelevant. What risk is there - death? But we are all going to die eventually, and I'd rather go quickly from PML than bedridden, incontinent etc for the final years with advanced MS. Those without the disease can never understand the daily torment we go through.

Tysabri gave some sufferers a better quality of life and hope. Some died on the trial but the circumstances are not clear as to what caused the deaths. It is likely that Tysabri contributed to the deaths but given the nature of this disease it might be a risk worth taking for some. It would be interesting to survey all those on the trial with the questions (a) did Tysabri improve your quality of life? (b) given that there is a risk of death from taking this drug would you still take it? I recall a posting on the Boston Cure Project site where a sufferer said 'life with MS is not much of a life at all''. I suspect that many feel this way.

Elan shares (the Northern Ireland company) went up yesterday which may mean that Tysabri could be making a comeback.

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Re: Hello Harry

Postby HarryZ » Wed Nov 16, 2005 8:07 am

Hi "Bull",

While targeting the VLA4 component of MS may solve one problem, it can open up others for MS patients. If you were to read a lot messages posted by Odduck in the Tysabri info thread, she outlines many of these dangers which have also been raised by some MS docs.

But Tysabri still doesn't address the original possible cause of why myelin is breaking down and thus causing inflammation and immune system reaction. And because MS patients are usually already immune system altered, the docs really don't have much understanding yet on how Tysabri is going to affect the infection rate in these patients. Two years of trial data on relatively mild MS patients doesn't give them a lot to work with. I can only go by what some of the MS docs have already stated and that is there has to be a great deal of caution exercised when using this drug. That means constant monitoring for infections and PML, something that wasn't being done when the drug started to get used in the general population in January of this year.

Yes, Tysabri was planned to be a serious "business threat" to existing MS therapies.... in fact Biogen clearly outlined this in their publicly posted marketing plan for the drug. Had Biogen/Elan taken more time to study the drug and learned about the PML before getting FDA approval, it likely still could have been in the "driver's seat" for MS medication. But now investors are saying that while it may come back, it won't be in the "blockbuster" category once thought and expected.

By the way Harry, I sadly know of 3 MSers who have committed suicide because of their sudden loss of hope after Tysabri was suspended. What a terrible shame.


I totally agree with you on this and if you read many of my previous messages, I have stated that Biogen/Elan could have avoided this fall-out from pulling the drug had they stuck to their original trial schedule plan and approval process. But when they saw the potential revenue, everything got accelerated and they got blind-sided by PML. And as usual, it's the MS patient who suffers the most in these situations.

Take care.

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