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well....fda granted priority review as of yesterday...so sooner is on the table

I guess it depends on how one views "sooner" or "later". Originally, some people thought that Tysabri would be back in business before the end of the year. The priority review request by Biogen/Elan hoped that the review would be done within 6 months (priority) as opposed to the standard 10 month waiting period. The priority review by the FDA now means that they will review all the data given to them by Biogen/Elan within 6 months and then give their answer.

I think it's very likely that Tysabri will be re-approved....it's just a matter of what kind of restrictions the FDA will place on it.

Harry

HarryZ,

You have made some really informed contributions to this site but lets have a few days / weeks where sufferers can live with a bit of hope that this treatment may be available again in the future.

There are always going to be risks with drugs and the risks of taking drugs which affect the immune system are bound to be higher. But as Bull has said he knows 100% that his disease will progress and more disability will accumulate (as it will for all of us with this disease).

You will no doubt hear rumours of further problems etc etc with this treatment and issues about Biogen's manipulation of the trials data etc etc. But the real test is whether this drug brings about improvements in the quality of life to those with this disease - and it looks like a number of those who took it saw real benefits (and I imagine that some did not - and I know that some died).

There's a bit of hope in the MS world at the moment - there's bound to be a downside but don't spoil the party. If I was you I'd take a long walk and enjoy an autumn day. One of the things that I really hate about this disease is that I spend too long on MS websites. But even worse is someone without MS who spends too long on MS websites!


Bromley

I have a party planned for the day Gary's MS is considerbly better or better yet CURED! And yeah, I do believe that party will happen soon. I have hope and Tysabri looks like the best shot as of yet. May work, may not, but it is our hope that it will. I really don't care what the data says for the most part. If I put all my hope in what DR and data say, then Gary would be in a wheel chair now. He was told he would never walk again in 1984. Well he did, and then he didn't and then he did, etc, etc....

Hi Ian,

You have made some really informed contributions to this site but lets have a few days / weeks where sufferers can live with a bit of hope that this treatment may be available again in the future.

I'm trying to figure out how my last message leaves potential Tysabri users without hope. I've repeatedly stated that I think Tysabri is going to be re-approved with some added restrictions. The time lines that are quoted aren't established by me but from information that has been posted not only on this site but on various other MS forums.

Living with hope is very important when you have MS but there is nothing worse than being promised something and then have the promise broken time and time again. If you feel that information which may contradict what is being told to MS patients should not be posted, then that can easily be done.

Take care.

Harry

HarryZ,

I'm all for freedom of information and for ensuring that the risks of drugs are properly relayed to potential users. But when you look back at your posts they are generally on the negative side especially about Biogen and Tysabri - and probably justifiably so in may respects. But given your knowledge about this disease, and the contacts you have, it would be nice to hear about a positive story e.g. a drugs trial or possible treatment that you've heard is going well.


Ian

For many months I've been following the banter that Harry generates. I must say that as long as the jabs back and forth stay civil, it is very entertaining. But I like to think that's not why I follow it. I follow it because I find his dose of cynicism/caution beneficial, and the debates that ensue are once in a while informative. So thanks, Harry. And thanks to everyone else for keeping it civil.

But I'm also in favor of taking a walk on a nice autumn day!

carolsue

Carolsue/Ian,

I fully realize that my comments about Biogen's manner in handling Tysabri are not positive and it isn't always enjoyable to continually poke holes in that company. For those who know me, I'm not a negative person and am very easy going.

At the same time, the frustrations of following MS research now for over 40 years and listening to an awful lot of garbage from some drug companies, make me always want to give the "other side" of the information that we read about MS.

I have also been raked over the coals on more than one occasion because of my views and had to endure some pretty nasty verbal attacks by a few readers on various MS forums. I will always defend someone's right to give an opposing opinion but if someone decides to get "nasty" with me, I won't back down. Most people like yourself, Ian, have disagreed with me in the past but do so in a civilized and polite manner and like Carolsue stated, some interesting discussions can take place. That's what these forums are all about.

Ian, I wish I could give you some positive information that I have heard about when it comes to some very promising MS drugs. I have contacts that deal with MS on a daily basis but so far, there is nothing that can be scientifically proven at this time that will really help MS. You can imagine how that makes me feel as I see my wife suffer terribly every day after battling MS for 35 years. She is using Prokarin (and that's a real story in itself) to keep her head above water and not become totally disabled with the disease.

At the same time there is a lot of research going on with various possibilities but when it comes to MS, the process is agonizing slow because they still don't know what causes the disease and they can't look at the brain like they can with many other organs.

But Ian, I will be more selective with my comments on Biogen and Tysabri and try not to be too aggressive with them.

Both of you take care.

Harry

Harry -

I too have followed your and Ian's comments on Tysabri for months now. I still chuckle when I think of the time you all talked about getting together for a drink and I think it was Ian who suggested that you should attend - - but only if you didn't mention Tysabri. I was kind of sick of hearing your "one note" commentary at that point too.

But as someone who has been on Tysabri and who is seriously considering going back on, I have to say that I was upset to read in your last note that you will be more selective in your comments. As much as it has annoyed me at times to read your Tysabri posts because they make the same point, I realize that it is so important to hear that point - -and that it has to be said at every juncture so that we don't forget it. I have been dealing with MS only for 18 months, not the decades you and your wife have, and I find your perspective valuable.

So while I agree it would be nice to hear a something else more positive at times, I hope you don't tone down your critical view. And I hope that the debate continues regarding the content of those views.

To that end, I'd still like to learn more about what that Wall St. analyst learned through the Freedom of Information Act. I have not seen anything that fully explains what he found. Were the non-PML complications in the patients in the Tysabri sample significanlty different than complications one could expect in a control group? Does anyone know? Anyone gotten in touch with that analyst?

- Arcee

Arcee,

Thank you for your kind words.

Don't worry, I won't stop making critical comments about Biogen and Tysabri I just won't post a comment on every Tysabri message that appears which I sometimes have been guilty of doing.

Here is the article by the WSJ reporter. She had to go digging to get info on the 7 non PML patients who died from various types of sepsis during the trial. Prior to this article, I don't think I saw anything about those deaths...not that our friends at Biogen would go out of their way to make it public!

_______________

By SYLVIA PAG.N WESTPHAL
Staff Reporter of THE WALL STREET JOURNAL
August 29, 2005; Page B3

The multiple-sclerosis drug Tysabri, which was withdrawn from the market this year, could be linked to new serious side effects, according to an analyst's report.

Through a Freedom of Information request, Steven Harr, an analyst at Morgan Stanley, obtained a list of adverse-events reports made to the Food and Drug Administration related to Tysabri.

Following an analysis of the data, he issued a note Thursday describing adverse-event reports in which a number of Tysabri patients died of rare infections. "We're not trying to put a death knell on Tysabri, but there are
signals in there that something's going on. It's important for patients and investors to know," Mr. Harr said in an interview.

A spokesman for Biogen Idec Inc., of Cambridge, Mass., which manufactures the drug along with Elan Corp., of Dublin, dismissed Mr. Harr's report. The spokesman said Biogen and Elan had performed a detailed safety analysis of the drug and found no statistically significant differences between serious adverse events with patients given Tysabri and patients given a placebo in several clinical trials.

"We have an enormous amount of information in our hands," the spokesman said. "The [adverse-events] database is a limited tool." Biogen and Elan said this month they hope to get the drug back on the market.

The FDA declined to comment on the analyst's report.

Tysabri was taken off the market on Feb. 28 after a patient contracted a rare brain infection called progressive multifocal leukoencephalopathy, or PML. Two other cases of PML subsequently have been confirmed by Biogen and Elan. Out of those three cases, there are two confirmed deaths. It is suspected that the reason patients get PML is because Tysabri suppresses the immune system.

The analyst's report describes seven non-PML deaths in patients taking Tysabri that "appear to be related to immunosuppression." One death was owing to pneumocystis pneumonia, an infection that only patients with severely debilitated immune systems get; another was because of herpes encephalitis, a rare infection of the central nervous system. Four other deaths were possibly caused by sepsis, an uncontrolled infection that spreads through the body.

The report mentioned that the FDA database contained "numerous" accounts of serious, nonfatal infections that "suggest again that the toll from Tysabri
extends beyond PML."

Despite the possible new side effects, Mr. Harr said Tysabri has a good chance of returning to the market. Its efficacy is "so compelling" in MS that doctors are likely to want to prescribe it for their sickest patients even if the risk for immune problems is higher.

________________

Very interesting info, isn't it? It only leads to another question...if Biogen didn't make this public, what else might they be keeping under wraps?

Take care.

Harry

John has never had the need to be on Tysabri at this point but I'd rather know up front what it is all about. Look how quick Bromley had me in tears just because he pointed out a fact I hadn't wanted to see. For that by the way bromley I thank you. There is no need for us to live with our heads up our backsides hoping all this will go away as it won't.

This WSJ article is the one that I remember reading initially, but I'm wondering if anyone has seen anything since or contacted the analyst who did the research.

- I'm still left wondering if those seven incidences were among patients in the monotherpay group or the T + Avonex group.

- I'm also wondering if there is verification of Biogen's claim that there was no pattern to these incidences.

- And I'm also wondering what their immune systems were like to begin with and what other drugs they were on.

One of the more suprising things to me about the whole episode was the poor initial health status of some of the affected people in the Tysabri study. I guess I was naive, but I would have thought that they wouldn't have allowed people with serious co-morbidities and on lots of other medication to be in a clinical trial. Besides the fact that it puts those people at serious risk, it really distorts the data.

Anyway, I'm curious what those of you with more experience in clinical trials and tracking down information have to say about this. And then I think I just may try and track down that analyst and ask him myself...

Thanks,
Arcee

Melody,

I never mean't to make you cry - apologies. Unfortunately, this disease if a very vile one and even when you think you are doing well you can never really be sure - I posted something recently about MRI scans taken evey six months on one patient - lesions came and went etc etc. I also posted some recent research suggesting that MS was a global disease of the CNS rather than just a disease of myelin.

I am in total agreement with HarryZ about most things - the woeful progress made in understanding this disease after 60 years of research and $X00s millions spent; the scandal of the drugs companies which make $4 billion a year from the CRAB drugs which are of very limited effectiveness (if at all); the non-existen treatments for those with progressives forms of this disease (SP and PP). You only have to look at the different therapies being used to show how poorly served we are e.g. LDN, statins, chemo drugs etc etc.

Our hopes are built up and then knocked down again - a cure (whatever that can be defined as) is always around the corner. When I met my MS nurse after my diagnosis in mid-2004, she told me that there was a breakthrough drug which was in the pipeline (at the time called Antegren). Of course the hopes of many were to be dashed when this drug was pulled. I agree with Harry that Biogen and Elan probably rushed the introduction and their PR departments worked overtime. Also, like most trials the numbers can be massaged to paint the best picture possible. The only slight difference with HarryZ and myself is that one has to be aware of sufferers' hopes. Many would like to see the return of Tysabri as it gave them an improvement in their quality of life and also hope. There just needs to be a balance in the postings sometimes - too many negatives can kill hope.

I'm off to see a neuro on Monday (MS is his specialism) and I'm going to discuss the DMDs. I will also try to find out what else is on the horizon, and his views on statins, minocycline, Tysabri etc. I'll post the feed back I get (although sufferers should consult with their own neuros etc). But this neuro looks like he has done some interesting researh so at least he should be up to speed with current thinking etc.

If I knew your address Melody I'd send you a box of tissues.

Ian

PS It's about time you Canadians came up with some good news. You've got some top-notch researchers but things seem to be very quiet at the moment in terms of research news.

Ian,

PS It's about time you Canadians came up with some good news. You've got some top-notch researchers but things seem to be very quiet at the moment in terms of research news.

Although still a few years away before any meaningful results are known, there is a pharma in Edmonton AB called BioMS that has been working on a peptide for SPMS. One of the few possible treatments for SPMS patients that is on the horizon. They are just starting up Phase III trials in Canada and have been given permission to do the same in Europe.

I'm sure they would have progressed further along the way by now but as usual, it's the huge amount of funding that is required....and they aren't exactly a big, rich pharma company....yet!

Harry

I agree that there seemed to be folks allowed in the Tysabri trials that had a ton of other issues going on.
But I also know that in any trial there are always a certain statistical number of 'incidents' that occur, that can, at face value skew the data. That is why statistical math applies. It allows for variance. The crazy thing that occurs with drugs and their path to approval is that ANY issue has to be reported. For example, if there is a homicide or a car accident the 'chance of death' stat is raised and must be reported as a death that occured during the trial of a drug.
Drug info inserts and such are mostly overlooked by the general population. Drug co's bank on that. The key is to hold yourself responsible for any med and or treatment that you choose. Education is key. I just happen to have personal experience with Tysabri that makes my risk/benefit analysis easier for me.
And it makes it easy to keep hope alive!
Heather

I have to agree with all about the Biogen episodes, rushing to market, etc... I am glad they pulled it for further testing. My opinion, mine only, is they have enough data to affirm that monotherapy is probably as safe as anything else out there. I know that Copaxon will never stop the disease and I know the data of how it is suppose to work. I know it did much better than data stats for Gary. I know of some people who have done worse than data stats. I don't think you can take a large group of people and say this drug will do this percentage of good, because some will do bad and some will do good. Some will have it to work and some won't. But with Tysabri, my gripe is IT SHOULD BE OUR CHOICE TO TAKE IT OR NOT. If you had MS or have a loved one with it, your views are much different. I would guess any disease is like that. But we are held up by the FDA. I think we all agree that one with the PML was an accident about to happen, anyway. So FDA, please hurry up. Some of us are anxious.