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.