This Is MS Multiple Sclerosis Knowledge & Support Community

I always said that if the people at the FDA or congress had the disease or a close loved one with it, they would all look at it differently.

Better.

I don't place all my eggs in the Cafepharma basket, if that's what you are asking! I have asked other sources about the melanomas and they too have heard about them....and are trying to obtain reliable verification.
Until that happens, they won't go beyond that point.

If you can remember, the oriignal Tysabri problems started out as rumor as well...and it unfortunately became true. We'll just have to wait and see with this latest information.

Harry

Harry, wouldn't the melanoma data have to have been revealed at the AAN conference? The rumors I have heard of secondhand noted that this "information" was known well prior to the AAN, which is why I have discounted it at this point. I can't imagine that Biogen/Elan would be as comfortable talking about Tysabri's return if this potentially gigantic liability was swirling. But as you've noted, stranger things have happened, so we'll keep our antennae up.

Arron,

I replied to your message yesterday but can't find the answer today!!!

I'll combine that message with new information that I heard today over on Brain Talk.

Until any melanoma information would be scientifically verified you can bet that Biogen isn't going to saying anything about it to anyone.

Now, at the recent AAN conference, some attendees are supposedly saying that the general consensus coming from there is that Tysabri won't be back for another 10 years!!! And the PML experts there suggested that it was indeed Tysabri that caused the PML.

Again folks, this is information taken from another MS forum and not confirmed. Hopefully that will be verified or denied in the near future.

Harry

interesting-- thanks for sharing

HarryZ,

You certainly know how to cheer people up. Are there any other side effects to Tysabri which you would like to share with us - athletes foot, piles, genital warts?

I am always interested in information on MS treatments but your efforts regarding Tysabri go beyond the call of duty. The treatment has been pulled which is a blow (even given the risks) to many MS sufferers who were hoping for something more effective than the current treatments. Given that 50% of RR ms sufferers go to Secondary within ten years, the suggestion that it will not be available for another ten years is sad news indeed.

Surely you do not need to knock any more nails in the Tysabri coffin.

Bromley


PS Just a suggestion - if I was you (you don't have ms) I'd be taking some long walks in the spring sunshine or doing numerous other things that this disease has robbed many with ms of. It's sad enough having ms and spending too much time on ms websites in the hope of finding some better treatments, but not having ms and spending too much time on such websites is something I can't get my head round.

I am the care giver and VERY disgusted at this point. Heard today they can transplant retinas, and people can see much better, even read. BUT the FDA has to wait 3 years, for lawsuit coverage I'm sure. It's not a MS issue, but how many blind people wil DIE blind because of the wait. Gary is blind, crippled, and losing working parts of his body often. Now what kind of HOPE is that? Side effects become less of an issue for people like this. Unfortunately, we have never had the funds to get necessary treatments, therapy, etc. when needed, so I am the person who makes a living, total care giver, general gopher, etc. I am tired and wish that he could do some more. Tysabri holds that hope. Some had improvement and some didn't. I am not looking at the data from a scientist, I am looking at people who took it. NOW I WANT TO SEE IF IT HELPS US! FOR GOSH SAKE, FDA, give us the chance.

amelia, we hear you loud and clear. Let's hope the FDA does as well. At the end of this investigation, we have to believe that it will be made in the best interests of the patients and not lawyers, drug companies, etc.

Please write them, the details are on the front page.

As for 10 years, I simply cannot believe that is reasonable. Tysabri has already been in development for 18 years, and has been administered to 8000 patients, many for over 3 years and many in combination with potent immunosuppressants. To date there is not one case of PML in Tysabri monotherapy (the Crohn's case does not count-- see our story on that on the front page). The investigation ends towards the end of summer. Let's not get too discouraged until that point.

Bromley,

I am always interested in information on MS treatments but your efforts regarding Tysabri go beyond the call of duty. The treatment has been pulled which is a blow (even given the risks) to many MS sufferers who were hoping for something more effective than the current treatments. Given that 50% of RR ms sufferers go to Secondary within ten years, the suggestion that it will not be available for another ten years is sad news indeed.

I can understand everyone's frustration about Tysabri and how the whole situation has turned into a total mess. I continue to wonder what would have happened had Biogen waited for their two year data and known in advance about the PML, BEFORE going to the FDA for approval. Perhaps the drug could have been used in a restrictive manner under proper guidelines but Biogen has now lost that opportunity for what appears to be a very long time.

As far as notifying people ....are you suggesting that I and others keep this new information, albeit unverified, a secret? Was it OK for Biogen to almost every other week make press releases about how good Tysabri was going to be for MS patients, outline their marketing plan on how much money they were going to make at the expense of the other CRAB drugs and then in the end, pull the drug because of the possibility that users might die using it??!!!

Please realize that this information is neither created nor initially distributed by me but by others who are much closer to the Tysabri scenario that I will ever be.

And when I watch my wife suffer every day with this dreaded disease, I am not immune to the pain that most MS patients have to deal with every day. Believe me, it doesn't make me happy to see a drug like Tysabri get yanked and leave hundreds of thousands of MS patients hanging out to dry! And when Biogen sped up their approval process with the FDA, my biggest fear was what exactly happened to this drug.

Harry

Arron,

I will echo your advice to Amelia in hoping that this Tysabri mess gets cleared up sooner rather than later.

I too was shocked when I heard about the ten year wait! Perhaps this information was being exaggerated at the source but the person who posted it on Brain Talk has very close ties to world of MS medicine. And it was another person altogether who relayed the info about Tysabri and PML.

I just shake my head when more and more info about Biogen and Tysabri gets released each time. And to think that this mess could likely have been avoided makes it even sadder. MS patients have to suffer enough every day without adding this to their plate.

Take care.

Harry

I have a dumb question. I know there wasn't an organized study of Tysabri and Avonex. But how long were humans on Tysabri alone in the initial stages of developement? I would assume, and we know about that word, Tysabri, in developemental stages was NOT combined with other therapys. If that is the case, what has happened with these people.

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Comments from an neurologist ( He attended the recent AAN conference )

"I attended all the sessions on April 12th and 13th. The speakers were professional and very careful to not raise or lower expectations. The implication was that the review would be complete in a few months and that the hope would be for a return by the end of the year. There was nothing firm stated. I would not trust the 10 year comment."
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We are all held at whatever they decide. So for now, I'll hold my head up a little longer. I know that researchers are going to stumble on a cure for this disease soon. Or at least, that is what I am going to hope for.

Better,

In trying to obtain more info from the AAN conference, the person who posted the original comment on the 10 year wait stated that it came from two docs whom she knew that attended. One had MS and was about to start on Tysabri and the other one was one of the chief docs in the Tysabri trials. The 10 year period was explained as likely 5 years of research and then 5 years of more patient trials. There also appeared to be two groups of docs...one group supporting Tysabri's early return and the second group stating a very long wait.

Sounds pretty much like the standard varied opinions in the world of MS medicine....with the MS patients, as always, caught in the middle.

Harry

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94% Of Neurologists Would Prescribe Tysabri


Since the multiple sclerosis drug Tysabri was pulled from the market by its makers, Biogen Idec and Elan , there has been a looming question: Will the drug ever be reintroduced? The medicine seems to have caused two cases of a deadly brain disorder that only occurs in people whose immune systems have been suppressed. The rate of the disorder is high enough that some analysts think Tysabri may never get back on the market.

Deborah Knobelman, a biotech analyst at Piper Jaffray, surveyed 134 neurologists who might prescribe the drug, and a whopping 94% said they still see some role for Tysabri. "The results of this survey not only give us more hope that Tysabri will ultimately return to market, but it also suggests that the drug will actually have some uptake, should it return," writes Knobleman.

That could eventually have an impact not only on Biogen and Elan but also on rivals Teva Pharmaceutical Industries and Serono .

Matthew Herper
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