Hi Natalie and congrats on # 17!

It's hard to believe it's been that long for you! It's hard to believe it's coming on #32 for me, sometimes I feel like I just started and that I am like a child in the dark trying to find the door especially when it comes to what is happening with us and Biogen right now. :(

I may be wrong in saying it was Biogen, but I think it was during a discussion on a possible labeling change and that the FDA may want to include updated information on risk to people who have had long term exposure and what that risk was when it was compared to the actual number of patients with long term exposure and the number of PML cases.

One of the problems that seems to be coming through is that the EU is skewing the rates. I may be way off base here, but since most of the cases so far are from the EU, and Germany in particular, there may be something going on there that we are not seeing here. It's too early to say what it is, because it may be environmental, may be due to something they do regularly and assume is ok that we do not do, may be due to previous treatments, may be that they have more incidence of JC exposure than we do, who knows...but something is going on over there. Hopefully we will get the information we need so we can continue to feel comfortable with our own assessment of our risks as patients and our choice to take this drug. :hug:

I know, I can't believe I am up to #17. It seems like I just started, for sure, and I remember the decision to start was quite anxiety-provoking. I still wouldn't do it differently though. It's funny because when I started you were on #15 or #16 and that seemed like a long time to me--now I am where you were!! :D

If I could safely stay on this drug for the rest of my life I feel like I would never have to worry about MS. As of now, I don't always think about it.

I meant to ask you -- were the last 11 cases announced since Friday all in Europe?? None of them were in the US then?

Natalie,

Honest answer is we don't know what the truth is because they won't tell us.

We can search for info and let people know what we find out, but until they open the box and tell us the truth, we cannot confirm anything. That's why I don't say anything's confirmed. I quote sources and boards and spouses and patients and articles.

It sure will be nice when I can say...This is the official statement from 'blank' :(

I'll see my neuro tomorrow for my 32nd infusion. I'll talk to him about taking a break and the new PML cases.

Since he already mentioned taking a break last month as a possibility, I know he'll be ok with it.

He was also talking to us about a couple of the oral meds that will be out soon. Maybe if I do take a break, a good one would be available by the time I need to go back on therapy.

Or, I could take Copaxone again since it worked ok for me.

RW, correct me if I'm wrong. Doesn't Biogen/Elan have to report all PML cases to the SEC? Or do they get to decide what to report? Also, they are required to report to the FDA, correct? But that FDA info isn't necessarily public, right? I think Wiz said the FDA person she spoke to told her to use the Freedom of Information Act. How obnoxious.

My neuro talked me off the edge!
 

I just got off the phone with my neuro.

I had postponed my next Ty (#37 scheduled for 11/12) until I had some answers.

The good news is that I continue to test negative for the JC Virus (A few of our local labs can test for this). My MRI's look great. I feel good.

She did tell me that the presence of the JC Virus can make one more susceptible to PML BUT the absence of the JC Virus doesn't necessarily mean one is not going to get PML. Interesting.

I also mentioned my concern about the pre-infusion question regarding 'new or worsening symptoms'. I always hated that question, because the symptoms mentioned are just normal ms stuff, and my symptoms always seem a little worse as I near my next infusion. Her answer was that symptoms that worsen just AFTER an infusion, not just BEFORE, would be a red flag.

So, in a leap of faith, I am back on schedule for Nov 12th. I'm also having my MRI that day.

My neuro wanted me to thank EVERYONE who is advocating for the information that we need and deserve. She wishes every patient of hers was as diligent...

Keep fighting & Be well,

Nope. They don't have to report to the SEC. It's not considered to be a material event that affects financial operations until the FDA says that the risk rate is outside of the label statement.

They have to report CONFIRMED cases of PML to the FDA from the USA. They MAY report confirmed cases from other countries to the FDA. Anyone can file an AERS report to the AERS database, even people like us, but it may or may not get investigated. The FDA usually does an update on their Medwatch page when something happens in the USA, not in the rest of the world, and since the USA rate is still within the 1:1000 label, I don't see anything coming soon, but I monitor the page anyway.

Natalie, it was me Barbara at the FDA told to write or fax for info under the Freedom of Info Act :mad:
Glad #17 went well for you! I will get #40 day before Thanksgiving.
Linda

More interesting info!

France has had NO cases of PML. Their medical prerequisites require them to test for CD4/CD8 counts to check the status of each patient's immune function and they do it to every patient. If the count is too low, no Tysabri until the count is normal. So, if a patient has a lowered immune system due to using another drug or anything else, no Tysabri.

JCV carriers:

"JC Virus has been used as a genetic marker to infer early human migration patterns. But new analyses show that it may be an unreliable indicator: this ubiquitous virus evolves much faster than previously thought and its evolutionary trees do not reflect known patterns of human population divergence.
Most of us contract JC virus (JCV) during childhood, from our parents. Only rarely does infection cause disease; mostly, it remains unnoticed, and we pass the virus on to our children in turn. JCV has at least 14 genetically distinct subtypes, some of which are associated with specific human populations — for example, type 7A predominates in Southeast Asians, types 3 and 6 in Africans, and types 1 and 4 in Europeans.
The parent-child transmisison route, together with the population specificity of particular subtypes, has led some researchers to use JCV as a genetic marker for tracing early human migration patterns. Furthermore, rates of JCV evolution have been inferred by assuming co-divergence with human populations over the last 200,000 years.
However, Laura Shackelton, Eddie Holmes and collaborators report that JCV and human evolution are not tightly coupled after all. When the researchers examined JCV from a variety of human populations worldwide, as well as mitochondrial genomes from the same set of human populations, they discovered that:
JCV is evolving much faster than previously thought
Much of JCV's genetic variability stems from a population expansion starting around 350 years ago, much later than early human migrations;
Evolutionary "trees" for JCV do not map at all closely onto the evolutionary history of humans inferred from mitochondrial sequences"

From a study published in the Journal of Virology

This makes me wonder if only certain subtypes of JCV are prone to developing into PML.

So many questions, so little known...sigh

Wow, France has no cases of PML? Do they only test the CD4/CD8 counts before treatment starts? Or do they also test periodically along the way, like every few months or so. Perhaps we should ask our neurologists to test for this? RW, where did you get the info on France?