Oh no, here we go again. :rolleyes: I vividly remember all the speculation from 2005 . . . waiting for the next shoe to drop. Most of it was hype, and hopefully it is again.

I listened to the tape from that conference call this morning ( http://biz.yahoo.com/cc/9/96099.html), Marc, and they did seem very evasive about how many people they've tested to date for PML. They just kept repeating that these were the only two confirmed cases, and that the confirmations came through on July 30/31.

It appears that the doctors of these patients were very diligent in discovering the PML, although it took 2 months in one case, and 2 1/2 months in another to confirm. I guess the first test they did (on at least one of the patients) gave a false negative . . . so it seems that IT IS IMPORTANT TO RETEST!

They also said that there is an understanding by doctors that they should stop Tysabri and start treating with plasma, as soon as they suspect PML. Apparently this treatment "removes" Tysabri from a person's system quickly.

It is good that they are getting much better at dxing PML earlier though, and have a few options to potential mitigate the damage.

Even IF there are 12 new cases, that is still only 17:32,000. That’s ½ the odds they predicted.

There are some that have genuinely run out of mainstream options (like me), but that doesn’t mean we don’t have any choices left.

And, sometimes NOTHING is better then "something" . . .

In that conference call this morning, they said the % of people who are currently using Tysabri as a first line treatment was still in the single digits. However, I've run into several people, even on the forums, who have dropped out of using the CRABs without giving adequate time for adjustment and/or for the drug to take effect. The "don't work" is very subjective.

Tysabri is the preferred option for many simply because it seems to offer bigger bang for the buck, ie. less adjustment and possibly better efficacy.

Cherie

One other thing to keep in mind is that there is no TOUCH protocol in the EU like we have here in the US.

When the hearings took place for the TOUCH protocol and RISKMAP for Tysbari, one of the issues that was discussed was a reliable test for PML. The docs all agreed that the tests currently on the market sometimes gave a false negative and that most of the signs for PML were visual and MRI. Patients should be watched and retested. Due diligence on the part of the doctors and staff was the key. That was also the reason for the push for continuity of care at the infusion centers - same staff member each time you were seen because they would be the first to notice any neurological changes. We were tough on MSActiveSource to make sure that the protocol was followed and that you, as patients, reported the protocol not being adhered to.

Some of you may remember the questionnaire I sent out over a year ago for the panel I was on to evaluate the RISKMAP? That was to call to Biogen's attention the lack of detail at some Infusion Centers by the TOUCH protocol trained personnel. I've been reading that some Infusion Centers are becoming lax in following the protocol. It's there for a reason. To try to prevent PML, period. And if a case of PML is suspected or dx'd, then a reporting system is in place, and a procedure is in place to treat the patient and treat the patient quickly.

One of the two patients in EU has been tx with Plasma Exchange which gets Tysabri out of the system immediately. The other one is in the hospital hopefully being treated with PPX. The quicker they know that they have contacted PML, the quicker they can be treated.

We all need to relax and let the dust settle and see what happens.

It would be interesting to know if TOUCH/RISKMAP had been a requirement in EU, if one or both of these patients would have qualified for Tysabri. Just my wondering....

Touché! Very good, Victor!

Commercial fishermen? Should we be watching out for killer fish or leaky boats!? :Sinking:

And if we wear our seatbelt and stay within the speed limit, our chances are probably even much better. ;)

Just make sure you all don't let yours Docs and infusion centers fall down on their jobs. Insist on being tested often enough to catch it early, to help your chances, if you do contract PML or liver disease...etc.

Good Luck and Wishes..:grouphug:

my Ty Infusion experiences
 

For my brief experience with Tysabri in Vancouver, BC Canada. I was the ONLY patient that I ever saw stay at the infusion centre for the 1 hour observation period. I'm sure there were others, but I never met them. The nurses had a waiver that I was asked to sign EVERY TIME to skip this step of the infusion protocol. I ALWAYS refused and said I'd wait the extra hour in a walk-in clinic waiting room, filled with sick people:eek: It was rather awkward and I am sure that many patients felt pushed to sign the waiver and just leave when the infusion was done.

At one infusion, I was asked the pre-screening questions during the infusion and a my LAST infusion, I was never asked the questions!! I knew the answers... but this is a HUGE breach of protocol IMO. When I told my neuro about this, he showed me the checklist where it says I was pre-screened. Of course it wasn't signed by me!

The monitoring/safety program is called Tysabri Care Program (or TCP). I found it to be a joke.

Hi Weeble :Wave-Hello: . . . I think I just figured out who you are by your comment, and I had asked Cheryl if she knew how you were doing a few months back.

If so, nice to see you again. If not, nice to meet you. :)

So . . . did you continue on with Tysabri somewhere else (other then Vancouver), or did it end up being not the right drug for you? How long ago did they start infusing Tysabri in Vancouver, do you know?

Way back when, my big concern about bringing this drug back to market was that patients got adequate pre-screening, warnings and monitoring. It's not the people on the forums that concern me so much (they know the gig), but the vast majority of other PwMS who have no idea about this drug when they go to their neurologist.

I felt more assured when the TOUCH program was introduced . . . at least until about a year later when I learned that that was an American protocol only. I was actually starting to think that Biogen cared . . . but obviously it was more about what they were FORCED to do in the US.

That protocol should have been initiated in every country where the drug was introduced . . . but then again, perhaps that is my bias because I happen to value the life of PwMS in the Europe and Canada, as much as I do those in the US. :rolleyes:

As I said on the Tysabri sticky earlier today, no amount of monitoring is going to stop people from getting PML . . . but it concerns me that it seems we are perhaps not even pre-screening people for the drug adequately either. Bet that is going to lead to a few "oops" along the way.

Cherie

IMHO....

Based on what I've read in the Irish newspaper (and maybe a couple of other EU papers), the TOUCH protocol was introduced and recommended to countries outside the US. It was not required as other countries do not have the funds to administer the program due to their health care systems being overloaded and underfunded.

I do not think for one minute that BIIB/Elan cares more or less about patients outside the US than they do about patients in the US. IMHO, the problem lies with the individual country's health care system and how they choose to deal with any type of RISKMAP drug on the market.

There are other drugs on the market that can cause PML, not just Tysabri. They don't seem to be getting the press like Tysabri. Why is this drug so controversial? :confused: Because it's new.:confused: Because it was voluntarily pulled off the market by the drug company. :confused: Because it was returned back to the market after being scrutinized so heavily by the FDA. :confused: There are so many other drugs that are far more dangerous that should be getting a lot more attention that this...deja vu.

That's how I see it based on my experience and knowledge.

I was only asked all four of the questions during my first infusion. After that the nurse just asked me how I was doing. I was never asked to sign anything after my intial appointment when they went over the protocol with me.

I had to remind my neuro that he was suppose to see me after the 3rd infusion. I did not have a MRI prior to starting the infusions. Prior to my last infusion, I told the nurse about a new symptom involving eye pain. She went and told the doctor and came back and started the infusion. He did not come into examine me. I had to remind my nurse to slow down that particular infusion. She seemed annoyed. They frequently forgot to come in and check my blood pressure and pulse every 15 minutes during the infusion.

The nurse that started my iv never wore gloves. I watched her wash my blood off of her hands on two different occasions. Finally, she panicked when I had the reaction during my last infusion. I just listed all of these problems as I remembered them in no particular order in order to note that problems do occur at some infusion sites here. Hopefully, this was a unique situation.