Hi Elizabeth, glad to hear that your Neuro is looking at Tovaxin for you. I am personally very excited about this new treatment option, and wish you all the best with getting into the trial.

Hi Lauren, and welcome aboard.

I think you are going to like NeuroTalk, and I am sure you will find it very refreshing to meet such a fine group of astute and well informed members to interact with.

When I read your first two identical postings on this forum, my first thought was that you were a sales rep for Biogen. IMO, most of your posts read like some sort of over-the-top advertising campaign, with hugely broad-sweeping statements about a yet very controversial & unproven drug (in the l/t). Given that you too are a PwMS, I can see you are just very excited about having another treatment option available to you.

Please know that I wish you continued health and success from using Tysabri . . . however, I am concerned about some of your statements, assumptions, and a seemingly biased viewpoint about this drug. While I agree that none of us should have to defend our chosen treatment, we may very well be challenged on our ‘perception’ of the “facts”.

If I were in your shoes, this would have had ME questioning whether Tysabri might have actually caused the relapse, since this "severe relapse" occurred so shortly after the infusion.

Of course that is HIGHLY unlikely, but it just goes to shows that we can not jump to conclusions when we try new meds, especially after only one treatment.

Didn’t you only have the one infusion in 2005, then experienced another attack within a few months of it? (I understand that you have recently had another infusion, about a week ago too).

If this is your only experiences to date with this drug, how have you have already come to the conclusion that this is the “only MS therapy that has stopped my attacks”?

How do you know that Tysabri is going to work for stopping YOUR relapses with so little history to base your opinion on?

There are many choices of therapy available to us, not just those that are currently endorsed by the pharma companies and/or supported by the NMSS. Your comment, that you 'support people’s right to choose', does not seem represented by such points (above).

This is getting to be very OLD news now, but thank you for sharing your tape.

What does that sentence mean; "68% superior efficacy”. 68 percent superior to what?

Are you aware that the PRIMARY, and most important measure for a drugs effectiveness is it's influence on disease PROGRESSION? Tysabri did NOT fair significantly better in this regard, with the following reported/comparative results:

"In the AFFIRM monotherapy trial, 29% of placebo patients but 17% of Tysabri patients progressed in a two year period (based on a statistical model), a difference of 12%.

In the PRISMS Rebif trial, 37% of placebo patients but 26% of Rebif (44mg) progressed in a two year period, a difference of 11%.

In the phase III Avonex trial, 35% of placebo patients but 22% of Avonex patients progressed in a two year period, a difference of 13%."

QUOTE: XO++, Mark

Relapse rates, for which you have quoted the efficacy rate of 68% is simply a SECONDARY measure of a drug’s effectiveness. Although I agree it’s kinda’ nice if we happen to be one of the lucky ones to experience less relapses due to a drug, if it doesn’t significantly impact disability accumulation, quite frankly I’m not getting all that excited.

The “reduced relapses” stats that are presented to us, i.e. the 68% that you are advertising for Tysabri, are RELATIVE TO PLACEBO, not absolute. This is NOT very a forthright representation of how effective they are, IMHO. The same holds true for the “enhancing lesions” reduction stat, and a correlation between the reduced # of enhanced lesions' effect on disease progression.

The link that Sally provided for your reference is extremely relevant to the efficacy of these drugs, and may influence our decisions. Therefore, I encourage you to “point out the falsehoods for everyone to see” by providing specific details about where there is misinformation being presented.

Again, welcome to the board, Lauren. Hope you enjoy it here.

Cherie

I did see the NEJM report today...however, even though the patient had stopped immunosuppressants 8 mos. previous, he had been on that therapy for 5 years, and there is no way to demonstrate that his immune system was functioning normally when he began Tysabri infusion. In fact, his immune system may well have been very abnormal after such protracted immunosuppressant therapy.

The best evidence I know of is that there have been no cases since, and while we must wait and see, every day which passes without incident makes everyone a little more confident in the safety of Tysabri in monotherapy. So, time wil tell; but I'm not holding my breath at this point.

Hi Rex,

I had saved this graph from a conversation we had last yr on OBT, which shows which drugs he was on, etc.:



There is no doubt that his immune system was compromised, but the problem is that many of ours are, from steroids, chemo, CRABs, etc. However, he was on Tysabri as a monotherapy at the time of his death.

You are right, time will tell.

Cherie

Thanks, Cheryl for your post and for the chart. I had not seen that until now...Wow, Poor guy.

I'm also interested in how the Lawsuit against Biogen and Elan, by Anita Smith's Husband, goes. She is the first person to die from PML and was on Avonex and Tysabri.

Well, first off, has Biogen taken responsibility for the PML?

After getting all of my slides, doctor notes, and so forth, they told me that they were not responsible for my lung and heart damage. Even though Mayo, who examined me did attribute it to the recalled avonex.

Its just another case of refusing to grow up and accept responsiblity for wrongdoing, in my opinion.

I'm anxiously awaiting the results of this trial too, mostly because I want to know if this lady actually had MS or not.

For a long time there was much discussion about whether we can "count" her, because it was alledged that she "didn't really have MS". I'm not quite sure why she wouldn't count anyway , but she had the MS label for quite some time and had been treated with Avonex for yrs.

If not having MS was indeed a factor in her death, ie. she shouldn't have been on immunosuppressants, then I would be very concerned that there are potentially many people who don't know WITHOUT DOUBT that they have MS. Clearly they thought she did . . . And if she did have it, we're back to square one; another MS'er who died from this drug (combined with Avonex).

Cherie

You should have sued them, BBS, the bastids.

The Lawfirm representing Mr Smith, has gotten all kinds or interesting info and scientific reports. On report shows that by adding Avonex to the tysabri, actually increased the half life of the Ty, causing it to stay in the system longer, so that the Tysabri was accumulating and She was getting twice as much as she should have.

Google Anita Smith Lawsuit..Lots of info. Did you know that one of the scientists who came up with Tysabri and tested it on animals, said that it was too dangerous to use on humans?

Thanks Cherie,

I just hope I have the T cells when I get the blood test. Seems odd to wish for something like that, but that's what it takes to qualify for the trial. BTW, you're doing a fine job here.

I suppose that was possible but the patient's health, with the exception of the problems associated with Crohn's, was very good when he started on the Tysabri. His viral blood count was normal...until he started to use the Tysabri which indicates the JCV virus was not active.

You are very right in saying that we will just have to wait for more safety data as more patients start to use Tysabri.

Harry

Sally,

Other than seeing more $$$$ at the end of the rainbow, I just don't understand why Biogen combined Tysabri with Avonex in a trial

Here they were testing a new drug in a Phase III trial, certainly had very little safety data about it at that point ....yet were mixing it with another immunomodulating drug!! I mean, really

Harry