Ah come on, Vic! You? Wanna jump out of my airplane?

That's what I got out of the SEC filing information is that the protocol wasn't followed. Oops!

Well, I'm very thankful there is a protocol, and this is the reason that many of us fought for a program such as TOUCH to begin with.

What wasn't followed though, Cheryl?

From what I've read, all we know is:

- that one of the patients took Beta-interferons (which many of the people now on Tysabri did at some point)
- that the same patient took another immune suppressant drug previously (but we don't know when, and far as I know there is no guideline saying she should NEVER have taken Tysabri, if she did :confused:)
- that neither patient combined Tysabri with any other therapy
- that the second patient has never taken any other disease modifying or immune suppressant drugs

What I did see from the safety and prescribing information, a person should not take Tysabri if they have:

- PML
- Are allergic to TYSABRI or any of its ingredients

... or if they are "TAKING medications that could weaken their immune system". Other then that, a person is meant to "talk to their doctor about medications" they've taken in the past. We don't know that this patient didn't, do we?

The allergic reactions they say to look out for include such things as hives, itching, chills, rash, nausea, etc. . . . but since most infusion centers now pre-medicate with antihistimines, I don't see how they would know if someone is allergic anyway. :confused:

Because of the yet unknown risk for PML (as a monotherapy) Tysabri is also only generally recommended for those who have not been helped by or are intolerant of other therapies . . . yet we know first-hand that neurologists are recommending this med as a first line approach to treatment now.

Seems to me that no one is actually following the proper protocol now, so every PML case is likely to be a "oops".

Cherie

AZO is not to be taken with Tysabri. Even though the report says Monotherapy, that means only ONE DMD. AZO is not a DMD as defined by the FDA and the TOUCH protocol. It's Imuran, an immuno suppressant used for kidney transplants (most commonly). Not used for MS.

I am by no means an expert, Cherie, but all we can do is wait for the final report.

"we" don't know anything more than what's been published thus far and "I" am only reporting what's been filed by Biogen with the SEC and expressing my opinion based on my experience and knowledge.


Just a reminder that when Tysabri was first released, everyone was pre-medicated with benadryl and tylenol 30 minutes prior to the infusion.

This is just like the same hype that everyone went thru when Ty was pulled in 2005.

"Patient in EU with MS with a history of prior disease modifying therapies including azathioprine and beta-interferons

The patient did not take AZO with Tysabri, so far as we know. She took it prior to Tysabri.

Are you reading that the patient took them together??

Cherie

I know everyone gets all in an upset when anything negative is reported about Tysabri. However, does anyone know the fatality information for the interferon treatments? If I remember correctly - (and I don't always!) - I saw something in the last few months that listed interferons as one of the top 10 medications leading to death.

I agree with Victor - then again, I, too, have jumped from a perfectly working airplane @ 13,000 feet. ;)

I know when I pushed to get on Tysabri, it was worth every risk...because the risks were small when compared to the possible benefits. Then again, I also just opted to have my immune system killed off and re-booted. Guess I'm a risk-taker?

Hopefully we will have more information soon and that the panic doesn't get out of control.

~Keri

Do you know that for fact? I don't and I am done with this.

:)

It doesn't say when she took it. It just says history which could mean yesterday. You know that as well as I do. They aren't going to release any more information than they have to.

My point is that they are saying it's a DMD and it's not. It doesn't say WHEN she took it. She has a history of it, period.

I don't know any more than you do, unless you know this person or are her treating physician. I don't and am not.

If you will remember, that was one of the drugs that the Crohn's patient had on his list of drugs that he had taken some time during the clinical trial but not concurrently with Tysabri. He contracted PML and subsequently died.

It's not necessary to red bold for me, I can read. ;)

Good night Cherie. :D

You were the one that suggested there was an "oops" in protocol, but I couldn't see where there was one. :confused:

I took the "facts" from the Tysabri prescribing information that you posted:

And the patient details from "UNITED STATES SECURITIES AND EXCHANGE COMMISSION report (that you also posted):


Your link says "prior" use of AZO, which was obviously "prior" to using Tysabri (since that same link also says the patient was on Tysabri monotherapy):

"Case 2
• Background:
- Patient in EU with MS with a history of prior disease modifying therapies including azathioprine and beta-interferons;
- TYSABRI monotherapy for approximately 14 months;

I don't see what relevance (what they are calling it) has to anything :confused: . . . but if you "Google" Azathioprine, it is included as a "disease modifying therapy" by many sources, as per this (UK?) government site:

http://gateway.nlm.nih.gov/MeetingAb...102271717.html

As to your second point, it does say "prior" to Tysabri monotherapy. Seems pretty clear to me. :cool: Yes, we don't know when . . . but we also don't know if there was an "oops" then either, do we?

None of this changes people's choice to take risks, of course. All it does is more clearly define what the actual risk may be to monotherapy Tysabri . . . and then it's up to the patient to decide if they want to go for it anyway.

Cherie

I agree that this new information is NOT worth panicking about.

It's just another piece of the puzzle for people to consider.

Cherie

All I know is that the company expected more cases of PML and made us aware that liver damage could occur in as little as 6 days, in a statement a few months ago.

http://www.fiercepharma.com/story/bi...pml/2008-03-19

I don't know what the basis for their statement about PML was, but I think as more people are participating with this therapy, more will be learned.

Everyone has a different way to assess the risks they are willing to undergo, and we are all learning from one another, in the end.