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.

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.

Correct. Not sure if that was in response to my post Cheryl but just in case, I wasn't disputing any of those things. I'm not aware of anyone who is, actually.
Just so we're clear. I was commenting on the article in the Irish Times.com and your apparent summarization of it. That's all.
http://www.irishtimes.com/newspaper/...628367341.html

The manufacture of a product bears the brunt of the responsibility for ensuring its safety, IMHO. We shouldn’t even really have to have regulatory authorities to oversea that this is what transpires . . . but unfortunately we know that not all businesses are ethical.

It’s one thing if a product is not known to be unsafe, i.e. accidental or unknown contamination . . . but it’s quite another when they already KNOW it needs to be monitored to ensure safety for the people who are going to use it!

We’ve seen how it works . . . the minute there is a scare in the US that a product bought overseas is tainted, it’s all over the news that “Mexican tomatoes” or “Chinese Barbie dolls”, or “Canadian Beef” are BAD. In this case, it is “American Tysabri”. Your FDA is not/can not be blamed for this occurring, but the companies that manufactured the goods are (as well as the country of manufacture, often).

How about we package/handle/provide mandatory instructions for only our Canadian consumed beef . . . but export something that WE KNOW is not going to be properly monitored to the US? With any luck, it may take the US government some time to figure out that their people are at considerable risk . . . and in the meantime we can cash out on our millions of $$ in shares that we were awarded for such great marketing of our product!!

The buck stops mainly with the manufacturer to ensure they are selling a product which will be as equally safe for consumers, no matter where it is consumed, ESPECIALLY if they already know this is a necessary component.

Cherie

There is NO safe product. None. Every product you can injure yourself with or potentially die from if you misuse it. A manufacturer cannot be responsible for complications when they've warned the public about the proper use of the product. Look at people drying pets in microwaves. Who would have thought that some idiot would do that when it's designed to COOK food. Duh.. animals are made of meat--just the thing you can cook in a microwave! You've just taken a business and called them unethical if they fail to make a safe product and ensure that everyone in the world uses it the way it was intended to be used. That's a mighty unfair burden to place on a manufacturer.

You're placing the responsibility solely on the business and not on the end user--the medical professionals who are ignoring blatant warnings that the manufacturer puts on its drug and the reported adverse effects. If they don't understand how to safely use a drug, they shouldn't be using it on their patients.

Governments poke their noses into plenty of aspects of daily lives of the citizens living in the countries in which govern. It's a fact of life. If this one drug is such a problem, I see no reason why other governments shouldn't ensure the safety of their citizens by mandating safety procedures that mimic those of the U.S. (or make up their own, stricter procedures). After all, if they regulate in the name of "governmental interest" in other areas, why shouldn't they this one? Governments routinely take interest in "life." Maybe it's not the companies--maybe it's the governments that don't see the need to protect their citizens in the same manner as the US does. Does that make them unethical too?

WOW . . . you’ve compared the “idiotic” actions of a person who supposedly micro-waved their pet (not true story, BTW), to the desperate actions of about 13,000 NON-US PwMS who are not currently protected by the “deemed” necessary TOUCH protocol?

I could banter every one of your points, Gazelle, but if you don’t "get" mine by now, you aren’t likely to. ;)

Cherie

Hi, Ewizabeth,

I´m from Europe and have to assure all of you that it is impossible to take Tys together with any other DMD´s in Europe. We do not have the TOUCH safety program, but a risk management program in Europe. Due to the strict rules of The European Medical Agency (the same as FDA in the US) Tys is allowed as a monotherapy only.

Thank you for that clarification, RuS. I would suggest this is true of Canada too.

What started this part of the discussion though, is that there was reference to an "oops" that might have happened with one of these two new PML cases in Europe . . . whereby the patient had used Azthioprine for up to 10 yrs prior to going on Tysabri. We don't know many more specifics in that case. . . but we do know that the Crohn's patient who died (in the original trials) also had used this same drug prior to going onto Tysabri.

That brought up whether people were being properly screened for prior meds and/or if there was adequate availability for PML testing in all other countries where Tysabri is sold. What we don't know is whether everyone on this drug is getting the full advantage of a TOUCH-type protocol.

If they aren't, this may be timebomb. It they are, GREAT . . . because we know then that PML is no more of a risk in any other country as it is in the US.

Cherie

Hi Cherie,

A bit of clarification on the Crohn's patient who died from PML after going on Tysabri.

This patient had stopped all medications for a least 8 months before going on Tysabri. Other than the symptoms from Chron's from which he had lived with for many years, he was relatively healthy. He was active in fishing and hunting.

His blood work was normal. Shortly after he started on Tysabri, the problems began. By the 6th infusion he became very sick with his white cell count skyrocketing.

Iniitally his cause of death was attributed to a brain tumour but it was later revisited and that's when they discovered he died from PML.

His family was asked to keep things quiet and not cause a fuss after the truth came out. Statements in press releases were made that were not true according to family members. The family was most upset at how everything around this patient was handled.

Harry

Hi Harry,

Thanks, I had forgotten how many months he had been off that drug before he started on Tysabri.

I guess we don't know yet how long this latest person had been off of it . . .?

Either way, these two aren't the only ones who've ended up with PML. There were two on combo therapy, and now this most recent one who was "drug naive".

It will take more then these to get any real patterns emerging, if there will be any.

Hope you are well! :)

Cherie

Hi RuSmolikova,

Thanks for letting us know, that's a relief. Hopefully there won't be any more cases of PML anywhere, but if there are, it will be caught early enough to avoid any catastrophic results.

These are "known" deaths or illnesses of PML in patients taking Tysabri. We only know what is reported to Biogen and what Biogen decides to report to the FDA.

Here is a doubting Thomas who thinks its possible there are/have been other PML incidents in Tysabri takers which were either not identified as such, or not reported as such.

Let's look at my incident with lung/heart lesions developing while taking th recalled Lots of Avonex back in 2004. Biogen refused to acknowledge that it had anything to do with the interferon, or anything to do with the interferon being faulty. So, its not "counted" as a side effect of avonex.

The research, in fact, shows that interferonin rare instances can cause sarcoidosis (which is what my lung/heart lesions were identified as). And yet, Biogen's position is that Avonex has not been shown to cause sarcoidosis, only interferon has been shown to cause sarcoidosis (and thats why they do not put a warning on avonex).

SO, if a company can say something like that, what else do they say or not say? At the end of the day, we only "know" about the adverse events of Ty that Biogen will report as such., and that the doctors in the program identify as such.

Oh. Ok. But no. I actually was disputing your premise: holding a manufacturer accountable for anything that could potentially go wrong with their product due to not using it as it was intended or deemed unsafe to do is ok.

But you'd rather turn it into me supposedly making an invalid comparison, which I didn't.

And I do get your points.

BTW:

http://www.bostonherald.com/news/reg...ome&position=0

see also:
Attorney Grievance Commission of Maryland v. Protokowicz, Md.App.Ct., 619 A.2d 100 (1993)
http://74.125.45.104/search?q=cache:...ient=firefox-a

Neither of those stories you’ve posted are about idiots trying to “dry” their pets in microwaves. Those people are messed in the head, full stop

And, I never said that manufacturers should be held responsible for “anything that could potentially go wrong with their product”. I said I felt that manufactures are responsible “to ensure they are selling a product which will be equally safe for consumers, no matter where it is consumed” (if they are going to be responsible exporters).

Each of us will have our own opinions on this, Gazelle. To each their own, Caveat Emptor, c’est la vie and all that jazz.

Cherie

BTW, I do agree that “A Hairy Chicken Is Better Than A Hairy Hand!” :D