sorry - turned into a rant
 

Hi Cherie, I may know you or Cheryl, but i don't recall knowing you :confused: This happens to me lots though.

I don't know when BC started with Ty, but when I started in Jan 2008, I was the 75th patient. There is only 1 pharmacy in BC licensed to distribute the drug and there are only 3 infusion centres: Vancouver, Burnaby, and Victoria. I live over 400km from Vancouver so I flew in every 4 weeks.

The official reason I was pulled from Tysabri was "non-response". Tysabri was just not my drug. I only tolerated 4 infusions. During/post infusions I had increased BP, facial flushing and minor throat constriction/cough. I premedicated with Benadryl before all infusions. I also had accelerated progression while on the drug. And a major exodus of my hair:eek: I have a family history of melanoma and had 11 biopsies of atypical lesions - all benign.:circlelove:

Since my last infusion, my progression has slowed, but I have had 2 relapses in the 3 months. 1 minor and one moderate. I will have another MRI in Sept. Curious if I'll show any rebound lesions. :rolleyes:

I am SPMS, and Tysabri wasn't designed for me. My MS has become +++aggressive in the past 2 1/2 years so I could really use a break. My lesions are in "bad" spots, affecting my heartrate, breathing, swallowing, voice, and legs. Not to mention pain. I'll be 40 in 2 days. Not what I imagined 20 years ago when my MS was "benign".

Oh my gosh Barb. That sounds so unbelievable as to be almost comical. Except it is not. Have you ever thought about reporting them? It wasn't like they made one mistake but many potentially dangerous ones. I know you've talked about finding a new neuro. Have you found one yet?

Weeble, I'm sorry the Tysabri didn't work for you. Hopefully you can find something that will work to slow things down. And flying in every month sounds like such a burden. Anyhow, happy 40th birthday. :)

I think Cherie may be thinking of Sandra, another member from the Vancouver area.

Sounds like you've had quite a time with finding a treatment for MS. I do hope you find something that works. SPMS is difficult from what I understand.

I had 3-4 exacerbations a years during the first 5 years after I was dx'd, but never progressed to SPMS. I have slowed down a bit on the rate of exacerbations but the severity hasn't changed.

Happy Birthday. :hug:

just for your interest
 

According to the Wall Street Journal (Aug. 2, 2008) the two new cases of PML were in Germany and Sweden.

Here is a link to the article posted on yahoo if you aren't registered on the WSJ site.

http://messages.finance.yahoo.com/St...10&tof=6&frt=2

Hi Weeble,

Cheryl is correct that I was thinking you may be Sandra. I looked back and saw you had had MS for many years, and you were from the Vancouver area, so I thought maybe Sandra had popped in to say “hi”.

Come to think of it, and if I remember correctly, Sandra never ended up trying Tysabri though. (My memory isn’t so great either.)

Welcome to the forum all the same. :)

Well, if there were only 75 people using it, out of a Province-wide demographic of about 4.5 million, I guess Tysabri/PML is unlikely to end up being TOO large of a problem. It sounds like they are reserving it for the most difficult cases then, which was its intended use. I am relieved to hear that, given that we don’t seem to have adequate screening or after-infusion observation occurring.

I'm sorry to hear that Tysabri didn’t work out for you though. You are very young to have so many challenges and I wish this would have been your ticket. Do you have difficulty with spinal lesions then (breathing, swallowing, pain)? Sounds like some things I've been through over the last 18 yrs.

I think I missed your introductory thread, so perhaps I will search for that to ask more questions. Although very young still, you are one of the “oldies” around here, as far as the disease process is concerned. I'm sure you can teach us a thing or two.

Cherie

Well perhaps we shouldn’t have introduced the drug then, as there is clearly enough reason to require the TOUCH program to protect the American peoples?

Having said that, from my discussions with everyone around here (including doctors, specialists, etc.), they are not willy-nilly prescribing this to everyone who claims it is their only option, and the specialists are generally not “recommending” it either. Perhaps this is how they’ve chosen to mostly keep people away from this option instead. :confused:

I agree, they don’t care more or less for anyone.

I don’t think (for one minute) that they would have voluntarily implemented such a program, or made it a requirement, if they hadn’t been forced to in order to bring it on the market. I think that is obvious, simply by the fact that they didn’t insist this level of care in the other countries where they are marketing the drug.

Your experience and knowledge on this drug is as biased as mine . . . we are just on other ends of the spectrum.:)

I am one of the few people who openly voices skepticism about Tysabri on the forums, but I am definitely not the only one who has considerable concern about this drug. We only have to look at how this kind of news hits the fan in the media to know that there are many people (and entities) that are much attuned to any new bad news that is uncovered.

Execs don’t suddenly sell millions of dollars of shares ... and the shares of a company don’t do a nosedive for “no reason at all”. Many people appreciate the enormity of such news, even if you don’t happen to see it that way.

You are right that there are other drugs that cause PML, and which don’t even require a TOUCH-type program. The necessity for such a program goes back to the history about this drug, which would likely have been long forgotten by now if the negative news (PML deaths, opportunistic infections, liver problems, rebound effect, melanoma scare, now the PML with monotherapy) ever stopped cropping up. So, yes, part of the reason is that it is a new drug . . . that continues to add to a scary history.

The main reason people talk about these “scares” though, is that Biogen has a stated goal of recruiting “100,000 PwMS, by 2010”. What do they care how many people get on it . . . except as it pertains to their profit? I am (was) a senior business person, and know very well the marketing strategies that are used to reach this kind of goal (even the part about “we EXPECT people will get PML”).

It is their prerogative to gloss over the risks, while some of us will continue to make sure people are fully informed of them.

In all honesty, I hope that people do well on any med of choice for their MS. I do think this drug might be helpful for some people, and those who want to try it certainly do NOT have to defend their decision to take that risk. On the other hand, I don’t think people who express their concerns have to defend their position to have concerns about it.

There is probably no way to meet in the middle on this, so we each continue to express our own personal views.

There is really no such thing as a company “voluntarily” pulling their product from the market. I have worked closely with the FDA, in a regulated company, and the way it happens is that the FDA ‘strongly suggests’ a course of action, ie. that the firm “voluntarily” withdraw/recall their product. If the company doesn’t . . . trust me the FDA will go through the hoops to legally force them to. That certainly does not earn them any favor with the FDA. :eek:

Controversy about this drug has been going on since before Tysabri was fast-tracked to the market . . . in fact, to way back when one of the primary researchers predicted there were going to be serious risks. It’s just ongoing . . . and will likely continue until all the uglies are uncovered and accepted.

Cherie

Well, I'm going to say this but for a different reason.

In my opinion what gets me is that you feel you have to constantly pick apart mainly FG's posts on this. If you weren't so focused, it might not be so bad as you do make valid points on some things.

FG's got one view on this, but she generally presents both sides. You have one view and it doesn't appear to me that you're as evenhanded with it. After a while, it's like reading a personal attack rather than a discussion.

I'm still trying to figure out why this is such an important issue personally for you, Cherie. Seriously. I am. I :Scratch-Head: and wonder why you seem to take it so personally. I am genuinely interested in knowing that. It might make all the difference in my viewpoint of things.

______________________

Each country has its own requirements for monitoring regulation of drugs for its citizens. Blaming the FDA is ridiculous. Medical professionals EVERYWHERE can either comply with or ignore known data about the drugs. That's their choice. And they ignore it at the risk of their patients' lives--no matter WHAT the drug.

Research data is freely available (reliable information) on the internet in about just as many places as unreliable information. Hopefully the medical professionals know the difference between the two sources.

The company puts out information with its drug. I'm sure that it's probably in the stuff that they send outside the USA borders.

So we're blaming Biogen/Elan for this? Very interesting.

Even aspirin has dangerous side effects. Who blows them out of proportion, however?

Cheryl brings up some valid points and questions ~ some of which I respond to from the other perspective. We are both experienced and know what we are talking about, with respect to this particular subject.

Each of our opinions/experience/'takes' on this subject go back a LONG, LONG way, and it is definitely nothing personal. Cheryl knows that. In fact we share similar views on many subjects, including Tovaxin, symptom management options, etc. :)

This is strictly about subject-matter, which I, as well as Cheryl (and others) feel passionately about. As it happens, neither her or I are on this drug . . . but we still have differing opinions in spite of that.

This is not the only subject I feel passionate about though . . . it's just the topic of the moment.

Cherie

I haven't seen that anywhere as of yet (about TOUCH protocol being recommended but not adopted in EU). I have seen this however, which is perhaps what you're referring to? (if not, I'm sure you'll post another link)

http://www.irishtimes.com/newspaper/...628367341.html

The neurologist quoted said "heightened clinical vigilance has been the best way to monitor for PML and that heightened vigilance was critical in identifying these cases..." (so something's working, whether or not they've adopted the protocol known as TOUCH) but also makes it clear that not all patients (she's referring specifically to patients in Ireland) are receiving that level of monitoring.

Even so, much as we'd like to think the TOUCH protocol is keeping us safe, I don't think the Biogen reps, when they say they're expecting to see more documented cases of PML in the future, are necessarily presuming those cases will be seen in countries other than the US (Puerto Rico and US Territories). Sadly, I don't think this problem will confine itself within others' national borders. We've had a few problems with infusion centers within the US adhering to the TOUCH protocol, too. I think patients - the brave ones on the front lines here - are going to have to be the most vigilant of all.

I'm hoping for the best possible outcome like everyone else, to be sure.

Fact:

FDA is a United States governmental agency. They have no jurisdiction outside the US to enforce federally mandated programs.
http://www.fda.gov/opacom/morechoices/mission.html

Fact:

TOUCH is an FDA mandated program.
http://www.fda.gov/cder/drug/infopag...b/default.html

Fact:

Biogen partnered with Elan and obtained a U.S. Biologics License Agreement (USBLA) to manufacture and distribute Tysabri in the U.S.
http://www.fda.gov/cder/drug/infopag...istorical.html

Fact:

Elan is an Irish company.
www.elan.com

Fact:

There is no FDA mandated TOUCH program outside the US.
www.elan.com
european union tab

Unlike the packaging label for the US, there is no mention of any mandatory monitoring program.