Glad to hear things went well, Maryann!

Like the others, it took a few infusions before I started noticing results. I wouldn't even post on what was happening for the first six months since I didn't want it to be wishful thinking. What I noticed was a gradual improvement, the little things, like not being as tired, not having to work as hard to compensate, vision clearing up and returning to normal were my most marked improvements early on, and the dreaded MRI that turned out to be the first one that was GOOD news!

After stewing over this daily for too many weeks, I am going ahead with infusion #32 on Thursday.

I'm choosing my quality of life over my fear. For me, this is the only way I can go and live with myself. I won't let fear control my life. It's like running a river, you look ahead and evaluate where you are at every stroke. Sometimes you run the rapid, sometimes you portage. I'm gonna run this one. I may portage the next one, I'll decide when it comes, with all the information that is at hand, but for today, this is my choice. I guess I'm a high risk kind of girl.

OTOH- I rebalanced my retirement portfolio today, locking in the recent gains, and eliminating a few of the riskier choices, adding in a few safer options...:Dunno:

I wish everyone well. :grouphug:

I hope all goes well for ( all of us:)) you.
I still keep reading 16 of the 24 cases were in EU with 60% of us users in the U.S.
I will go for my 40th on the 25th of this month!
Linda

Keeping you all in my prayers to stay safe and well..:grouphug:

I'm actually relieved that I'm off of Tysabri. I was feeling sort of worse at times, and since my MS wasn't really that bad when I started, I figured I better take a break just to be safe. I don't know if I'll go back on it or not.

I'm very happy for those who have had great improvements or stabilized symptoms while on Tysabri. :grouphug: I had some improvements but not enough to stay on it for this long especially with the recent events.

RW... :hug:

Wiz, if I had not had so much improvement while on Ty I wouldn't go for another infusion either. But, it has really made a difference in my QOL. I've been in California visiting my grandchildren for the past week. I really don't want to go back to the way I was before Ty. I'll have my 27th infusion on Friday. After that I'll take it a month at a time...........and ask my neuro for constant monitoring and advice. Since my neuro does not give me my infusions I know she has my best interests in mind. And, she, too, is concerned and is looking into other options.

If Ty didn't really improve your QOL Wiz then you are better off being safe than sorry!!!!!!!!!!!!!!!!!!!!!!!! That's just my opinion :)

Take care...hugs,
Shayna

I like that everyone is making the best decision for themselves -- you can only assess your situation, the risk/benefit profile, and what knowledge you have and then go from there. :) :grouphug:

Polar I can't believe you are up to #8 already! Maryann, I didn't notice anything until probably the 6 month mark except for my vision. The vision got sharper early on.

I will probably go off Tysabri at #24 (I've had 17 infusions) since my MS was extremely mild when I started (there were no post-marketing PML cases at that point!) The pills look promising but they come with their own set of issues (cancer is one of them which scares me too). I can't tolerate Copaxone or the interferons so it is looking like the pills -- but I will reassess next spring. Who knows...I may have a different set of facts then.

Well, infusion #8 is done and in the books. Everything went fine, except that I was a little cheesed off that I missed the only two hours of sunshine today :mad::)..
Natalie, I wish it would do something for my vision. It's nearly 20/20, but they don't work together like they should now and any little vibration, like sound or even something small like taking a step, throws my vision off and makes me dizzy. Maybe someday....

Glad to hear # 8 went in with no problems, Polar! :)

As to the vision thing, I had the same problem.

I never knew when it was going to go wonky on me. I was dizzy when I needed to have it together, my brain fought with what I saw all the time, causing massive fatigue and cognitive difficulties and vision was my worst problem, followed by all the stuff it caused!.

It was such a gradual thing, I just thought I was learning to live with it or adjusting to it or something. It wasn't until I went to the ophthalmologist and he kept testing me that I knew something was up. He was the doc who told me that in his opinion, I had MS. I'd been seeing him regularly from July 04 until Dec. 06, and then didn't see him again until Nov. 08.

When he sat down in his office with me and asked me what I was on for treatment, I asked why. He told me my vision was back to pre-diagnosis level and he was amazed. I'd been tested several times after diagnosis, and there was always something wrong, something new noted on my chart, a new word I had to go home and look up- diplopia, nystagmus, etc.

He had me walk up and down the hall repeatedly, hop on one foot, hop on the other foot, turn around several times, more follow the finger stuff...I was starting to feel like a circus act! He kept shaking his head and muttering that he had never seen this before. He asked all sorts of questions about Tysabri, and took notes. He told me to just use my glasses from pre-diagnosis because I didn't even need a new prescription.

He sent his report to my neuro and followed up with a call. At my next appointment the neuro was grinning and said "so you saw the eye doc?" and showed me the report and told me about the conversation. He said the ophth. kept saying how in all his years of practice he had never seen recovery from such a severe degree of eye problems from MS/ON.

I'm telling you all this so you will know that there's hope. The longer the inflammation is held at bay, the more repair that can happen, and there IS repair. It's gradual and you may not even notice it's happening.

I hope it works as well for you as it did for me. :hug:

Discussion of PML and Therapies like Tysabri next Tuesday
 

Immunomodulating Therapies and Progressive Multifocal Leukoencephalopathy (PML)
Tuesday, November 10, 2009 | 8:00 AM - 5:30 PM
The New York Academy of Sciences

http://www.nyas.org/Events/Detail.as...9-f83b1303698d

Key items from the listed abstracts

"Current presentation will examine the role that some of such viral and host factors play in susceptibility to PML. Specific focus will be given to the role that some mutations in the viral capsid proteinVP1 might play in the development of PML."

"This presentation will provide an update on the status of the programs and key learnings from TYSABRI associated PML cases."

# 32 down.
Usual day.

FDA updated the Tysabri label today
 

Applicable part of the label

"In patients treated with TYSABRI, the risk of developing PML increases with longer treatment duration, and for patients treated for 24 to 36 months is generally similar to the rates seen in clinical trials."

Guess they see the rate as about 1 in 1000 for those between 24 and 36 months.

Oh, I see what they're doing....giving that sub group of 24000, there own statistics..:rolleyes: we're smarter than they give us credit for..:) (for which they give us credit)

I had my 27th infusion yesterday....with my "normal" side effects. I still have a slight headache, a bit of dizziness and the achy feeling all over. But, at least the nausea is gone :)

I even saw the oncologist at the infusion center....it's been almost a year since I've really seen him. We normally wave as he walks through the infusion room. Apparently, the insurance company has informed him he must "see" me at least every 3 months or they won't pay for the infusions.

Rsults/Recommendations from German MS Society(LONG)
 

Translation of pertinent points from the original version in German:

Therapy of Multiple Sclerosis with Monoclonal Antibodies
Results and Recommendations of a Symposium of the Medical Advisory Board of the German MS Society

Autoren R. Gold*, H. P. Hartung*, R. Hohlfeld*, H. Wiendl*, B. C. Kieseier*, R. A. Linker*, S. Schmidt, K. V. Toyka*
für die Arbeitsgruppe Moderne Immuntherapie der MS1


{Page 334/335: Zusammenfassung [below the English version]}
Abstract.
Therapy of relapsing−remitting multiple sclerosis
(MS) has become more effective, but this progress
has unfortunately been associated with more
serious risks. Since 3 years natalizumab has been
licensed as the first monoclonal antibody for the
treatment of a neurological autoimmune disease.
In addition, there is now an increasing off−label
use of rituximab and other monoclonal antibodies
in a variety of immune−mediated neurological
disorders. Experience and insights arising from
applying these therapies will be used to define in−
dications, logistics for monitoring treatment and
adverse events, and some diagnostic and thera−
peutic algorithms for future innovative therapies
for MS and their potential complications. This ar−
ticle is based on deliberations of a symposium
held by an expert group of the German MS society
(DMSG) which had a focus on natalizumab. In the
future, when other novel therapeutic compounds
are to be licensed, this work will be extended, up−
dated and reported. This will help to improve the
practical handling of potential complications of
therapy in both inpatient and outpatient settings.
A structured interaction between different levels
of health−care providers will be an important
part of establishing robust quality standards
aiming at a high level of treatment safety. These
structural aspects are addressed in a back−to−back
article.
{Page 335: Einleitung / Introduction }
...
{Page 335/336: Wirksamkeit und Indikation von Natalizumab / Effectiveness and indication of Natalizumab }
...
{Page 336: Untersuchungen zur Immunkompetenz vor Therapiebeginn }
Verification of the immunecompetence before beginning of therapy.
For the accurate description of the immunecompetence there are, at this time, unfortunately still no evidence-based criteria, but is predominantly based on expert opinion or on similar research into experimental disease models.
The following exclusion criteria were suggested (after [12,13], supplemented):
* systemic fungal infections with Candida and Aspergillus within the last 6 months except [certain] parasytes and skin fungi
* currently active infections (urinary tract infections, pneumonia)
* infections with Herpes (simplex or zoster) and/or their reactivation within the last 3 months
* other opportunistische infections within the last 3 months
* HIV−infection
* chronic virus infections (e.g. Hepatitis)
* chronic or recurring bacteriological infections (e.g. Tuberculosis)
* malignant neoplasm (possible exceptions: treated carcinoma in situ; more than 5 to 10 years remission with treated carcinoma)
* organtransplantation with current immunesuppression

If the MS occurs together with another autoimmune disease, were possible a monotherapy certified for both illnesses or at least well tested substance should be aimed at.
Examples for this are Rituximab with MS (not certified) and Rheumatoid Arthritis, as well as Natalizumab with MS (certified) and Crohn's disease.
Concerning the laboratory values it has been noted that there are no exact (evidence based) guidelines, and that simple default values for blood leukocytes as well as the determination of the CD4/CD8 ratio are probably sufficient.
[i.e. no really specifc guidelines could be found, but if clearly below normal range then ...]
For some pre-defined infections patients should always be tested, before beginning of therapy (or at least when there are indications based on the patient's medical history):
* HIV should be excluded (with each patient and their possible life partner)
* VZV by missing history of smallpox or mssing inoculation (if necessary inoculation before therapy)
* Hepatitis-B- and -C serology because of case history and/or increased liver values.
Chronically active hepatitis and HIV infection have been mentioned as exclusion criteria for a therapy with Natalizumab.

{Page 336/337: Intervalle bei Therapieumstellung }
Washout periods before switching therapies
Here as well there are no evidence-based criteria / laboratory diagnostics, but only empirical data.
Because the biological washout of natalizumab as IgG4 is about 12 ± 14 days, and because there is biologicaly provable blocking of immune cell migration even at very small plasma levels [14,15], it can be estimated how long the antibodies will be present, before a new therapy is to be introduced.
Measurements of the serum concentrations of natalizumab are cumbersome and are at present only conducted at a regular basis by one laboratory in North America.
To be regarded separately is the switch from a previous therapy to Natalizumab and a switch from Natalizumab to a new therapy.
In both situations there is agreement that in addition to the immune status, which should fulfill the same requirements as above defined, minimum time intervals (safety intervals, washout periods) should be respected.
For glatiramer acetate and interferon-b, these intervals are short, ± 2 weeks were considered to be appropriate.
For agents such as azathioprine and MMF 3 months appeared to be appropriate.
For mitoxantrone and cyclophosphamide, however, a longer interval of eg 6 months or even longer (until 12 months) has been contemplated, where the choice of the safety interval in patients with high clinical activity should be carefully balanced in consideration of the risk-benefit ratio.
For some monoclonal antibodies (eg alemtuzumab) an even longer interval is recommended, because of the very long duration of action [of these drugs].
Regarding vaccines, there are no relevant safety signals, neither from studies nor in post-marketing setting.
There is therefore no need seen for a change in the vaccination approach from what is already common practice in MS.
For safety's sake titer controls should be conducted to verify the success of the vaccination.
With respect to exacerbation treatment, there are already many studies and observations from the post-marketing phase.
These allow the following conclusions:
* for acute relapses, steroid pulse therapy is possible
* with the escalation of plasmapheresis in principle also possible
* high relapse rates review of natalizumab indication; possibly lack of effectiveness of this immunotherapy, especially in the presence of neutralizing antibodies (see below)!

The clinical validity of surrogate markers like the ATP Assay of the company Cylex (http://www.cylex.net/technology.html) for functional testing of the immune status is at present not yet sufficient clarified. Thus this test cannot be recommended for routine use, at this time.
While the first cross-sectional data in MS patients and patients with opportunistic diseases are available, the working group sees urgent need for the future validation and establishment of such surrogate markers, especially for the monitoring of the status before and during immune therapy.
{Page 337: Durchführung und Komplikationen der Infusionsbehandlung }
Execution and complications of the infusion treatment
...
{Page 337: Verhalten bei Infektionen und operativen Eingriffen }
What to do in case of infections and surgical intervention
...
{Page 337: Verhalten bei schubförmigen Verschlechterungen }
What to do in case of relapses/exacerbations
...
{Page 338: Diagnostik und Therapie von Infusionsreaktionen und allergischen Reaktionen }
Diagnostics and therapy of infusion and allergical reactions
...
{Page 338/339: Neutralisierende Antikörper gegen Natalizumab }
Neutralizing antibodies against Natalizumab
...
{Page 339/340: Dauer und Beendigung der Therapie mit Natalizumab (Deeskalation) }
Duration and completion of the therapy with Natalizumab (de-escalation / phase out)


{Page 340: Überlegungen zum Thema Therapiepause (¹drug holiday“) }
Considerations about therapy break ("drug holidays“)
Occasionally it has been postulated that a short-term discontinuation of natalizumab ( "Drug Holiday") could possibly positively affect the benefit / risk profile of Natalizumab therapy. This strategy is based on the idea that the immune system could recover during a rest period.
This assumption is so far not supported by any data, and such a study would also not be feasible: to be able to demonstrate an appropriate risk reduction by short-term discontinuation of natalizumab, one would need a 2-year long study involving about 150 000 patients! In addition, there are currently no validated parameters for such an effect.
In addition to the risk of return of disease activity during the drug-free interval,the re-exposure to natalizumab, however, poses other problems, such as a possibly altered immunogenicity of natalizumab after reinitiation.
The consensus of the working group is therefore that the strategy of "Drug Holidays" during natalizumab treatment is not recommended, at this stage.
Should there be new evidence in relation to a cumulative, duration on therepy dependant, risk of PML development, then this will need to be re-evaluated, if necessary.


(thaks go to "teknowiz" for the translation posted to another board)

Biogen, Elan, Roche Forming Brain Infection Consortium
 

By Thomas Gryta
Of DOW JONES NEWSWIRES
NEW YORK (Dow Jones)--Biogen Idec Inc., Elan Corp. Plc and Roche are planning to form a research consortium dedicated to a rare brain infection that has emerged in patients taking a number of their drugs.

The move comes as cases of progressive multifocal leukoencephalopathy, or PML, have risen sharply in patients taking multiple sclerosis treatment Tysabri, sold by Biogen and Elan, prompting a panel of European regulators to review the drug. The infection, also found in users of several other immune system-suppressing therapies, is often deadly, and its emergence has perplexed physicians and researchers as they balance the risk and reward of these drugs.

It has appeared in patients taking some drugs used after organ transplants, as well as arthritis treatment Rituxan, sold by Biogen and Roche, and Raptiva, a psoriasis drug that Roche's Genentech unit pulled from the market earlier this year because of the issue.
Before these drugs, the condition hadn't shown up in patients with MS, or psoriasis, and was most common in patients with AIDS. There have been some reports in cases of arthritis patients, according to a Roche spokeswoman who declined to provide additional details about the consortium because formal agreements haven't been signed.

PML has been most frequent in users of Tysabri, with 24 confirmed cases since its re-launch in 2006, but generally consistent with the 1-in-1,000 patient rate implied by its label. The drug is subject to a rigorous risk management plan and the companies have been researching PML since its emergence in 2005, which led to Tysabri's temporary withdrawal from the market.

Mariska Kooijmans-Coutinho, Biogen's senior director of clinical trial safety and risk management, detailed the plans for the consortium at a meeting covering various aspects of the infection at the New York Academy of Sciences on Tuesday.
The group plans to pool resources related to PML, including the formation of a global database of cases in an effort to predict, prevent and treat the condition, she said.
The effort will also include non-profit organizations and academic institutions, and she invited other drug companies to join the effort. She noted that the consortium will seek financial and time commitments from companies to ensure stability in the group.

PML is caused when JC virus, which most people carry, attacks the central nervous system in people with weakened immune systems, often leading to an irreversible decline in neurologic function and death.
A higher number of Tysabri patients with PML have survived the infection, with only four dying since 2006, because of close patient monitoring and quick removal of the drug from the body. Regardless, the infection's nature often leaves survivors with varying degrees of disability.

Eugene Major, who runs the Laboratory of Molecular Medicine and Neuroscience at the National Institutes of Health, believes that the risk of PML in Tysabri is generally known, but he warns that the condition may be more common than thought in areas not related to Tysabri.
"It is pretty clear that it is underreported," Major said, noting that the NIH and Centers for Disease Control are forming a collaboration to increase the monitoring of PML in the broader population with the hope of gaining a better understanding of its scope.

I'm proud of you bunch of squeaky wheels..:grouphug:

I heard through the grapevine that they will soon be reporting the PML cases on the website again. Gee, I wonder why? :confused: It couldn't be because patients are dropping Tysabri like a rotton tomato and also that excellent oral meds will be released in the springtime? :confused: Just thinking out loud, don't mind me.

Frequency of PML under question with Rituxan treatment
 

While reading another board I came across a post about Rituxan and PML:

"Thomas Gryta's article today published by Dow Jones about the PML consortium got me to go back and review what I have about the relative incidence of PML (fatal and non-fatal) in Tysabri vs. Rituxan, particularly given a recently acknowledged third fatality from PML in a Rituxan patient. In his article, Gryta stated that “PML has been most frequent in users of Tysabri, with 24 confirmed cases since its re-launch in 2006.

While there have been just three “officially” acknowledged fatalities from PML among at least 57 PML cases in the approximately 100,000 patients who have ever taken Rituxan, there may be many more fatalities than are acknowledged by Biogen Idec, Genentech and Roche. See the October 2009 notification from Biogen Idec and Genentech
(http://www.fda.gov/downloads/Safety/.../UCM187792.pdf) as well as a similar November 9, 2009 notification from Roche sent to medical professionals in Europe.

A total of 57 PML cases, 51 of which were fatal, was reported in an article by Charles Bennett, MD of Northwestern University and colleagues, published in the May 14, 2009 issue of the medical journal Blood *, covering the period 1997 through 2008. According to Dr. Bennett and his colleagues, of the 51 fatalities among the 57 PML patients identified, the median time between their diagnosis and death was about two months.
I find it very curious that neither the FDA, the EMEA, Biogen Idec, Genentech nor Roche mention the other approximately 54 PML cases in patients taking Rituxan, nor the fact that there were an additional 48 fatalities identified by Bennett et al., just the three fatal cases acknowledged by the drug companies. Of course, there is no TOUCH-like risk management plan in place for Rituxan, so some Rituxan-related PML cases and even some fatal PML cases may have been missed.

So, how does the current total of 24 cases of PML in Tysabri (including four fatal cases) among 60,700 total Tysabri patients compare to the 2008 total of 57 cases of PML in Rituxan (including at least three and possibly 51 fatal cases) among 100,000 total Rituxan patients? My understanding is that Rituxan is generally used short term, while Tysabri is generally used indefinitely. It would appear that the incidence of PML in Tysabri patients taking the drug for less than two years is fairly low compared to the incidence of PML in Rituxan patients (most of whom, as I understand it, take the drug for two years and less).

Why is Rituxan being treated differently than Tysabri with regard to both fatal and non-fatal cases of PML? It is likely the history of Tysabri being removed from the market and then fighting to get US re-approval, coming on the back of the Vioxx withdrawal, while Rituxan has been on the market for 12 years or so, and the fact that there appears to be some link between Tysabri-related PML and duration of use beyond two years.

* An abstract of the Bennett et al. article as well as links to the full article are pasted below. The Bennett et al. article was reported in a May 20, 2009 article published by Northwestern University (http://www.northwestern.edu/newscent...5/bennett.html) as well as a June 1, 2009 article by Gryta''s colleague Alicia Mundy in the Wall Street Journal (http://online.wsj.com/article/SB124381351149970563.html).

Blood, 14 May 2009, Vol. 113, No. 20, pp. 4834-4840.
Prepublished online as a Blood First Edition Paper on March 5, 2009; DOI 10.1182/blood-2008-10-186999.

Full article: http://bloodjournal.hematologylibrar...urcetype=HWCIT

PDF of full article: http://bloodjournal.hematologylibrar...urcetype=HWCIT

Abstract: http://bloodjournal.hematologylibrar...urcetype=HWCIT


Another poster responds:

PML Incidence in Tysabri vs. Rituxan (ASCO study says survival rate after PML diagnosis in Rituxan treated patients was 3 or 9% out of 35 cases studied).
"Rituximab and progressive multifocal leukoencephalopathy: A report of 35 cases." 2008 ASCO report
at http://www.asco.org/ASCOv2/Meetings/...stractID=33229
In the abstract of the above study it states:
"Results: Of 51 unique cases identified, 2 were excluded for HIV, and 14 for inadequate confirmation of PML. In the 35 remaining cases, survival for 1 year after PML diagnosis was reported in just three patients (9%)."

A comment from the responder:

"It seems that deaths associated with PML in Rituxan-treated patients are not being reported or publicized in the media. It is a very good question you raise regarding why Tysabri is being treated differently than Rituxan with regards to associated PML."

(thanks to LJD and vl for above information!)

Saving the best for last! For WIZ!
 

http://online.wsj.com/article/BT-CO-20091111-716035.ht

Biogen Rethinking Disclosure Policies On MS Drug Tysabri !!

Gee, that's one of the websites I was posting my complaints to, imagine that. Could it be that I had some influence, however miniscule? :confused:

Doesn't matter to me, they need to do the right thing, whether I continue with Tysabri or not, because so many other special people deserve to have the information available to them. :grouphug:

I truly believe that all the noise is having an effect, Wiz.

I started laughing when I saw your post right when I was posting that news!

I have to tell you, I am not sure how involved I would have gotten with Tysabri and all the work it took (and still takes!!) if I had known that three plus years later we would still be fighting to correct misinformation and trying to get truthful, open, factual disclosure from the very company that should be kissing our hineys for all the work that so many people did. :(

This just came out today. Biogen says it still hasn't decided what to do re: disclosure of PML cases in the future although they won't go back to the weekly update.

"This is new territory," Biogen spokeswoman Naomi Aoki said, adding that the company has always provided regulators with case-by-case updates as soon as information is available, while providing physicians and patients with the information needed to make treatment decisions.

"Obviously, we are a publicly traded company, so we have to make sure we are being appropriate for fair disclosure," she said.

Aoki said that Biogen is unlikely to provide weekly updates, as it did between January and July, but said that it hasn't decided on how to alter its policy in disclosing cases. It has held a number of conference calls and Webcasts with physicians in recent weeks to provide details and answer questions about the new cases.


I think the patients need fair disclosure too!

http://online.wsj.com/article/BT-CO-...11-716035.html

Oh wait Wiz and RW! I just saw you posted this! :)

Especially all that you, and Cheryl and so many people did to get it back for the patients, and that you continue to do!!! I really hope this is affecting their revenue projections because that's the only thing that's going to make them change their minds about this. And thanks for posting the WSJ link. I need to go make a comment there as well. :hug:

I tried to post a comment on that blog/article at WSJ and they didn't accept it. Maybe if I suscribe and write a letter to the editor ... :confused:

Great article on Tysabri/pml
 

I read an outstanding article from the Rocky Mountain MS Center by Dr. Timothy Vollmer on pml/Tysabri. I am trying to figure out how to get you there-I am not terribly computer literate :o
I think you can go to www.mscenter.org and then on the left click on eMS news and then register it will come up. I get this in my e-mail. I have an e-mail address that of bblanning@mscenter.org that may be another avenue.
I hope you can find it, it is worth the read!!!
Linda

Hope this helps, Linda! :)

Click at the top of your browser where the address of the page you want to link to is, so that it highlights.

Right click on it and choose copy from the menu.

Go to where you want to paste the link and click where you want to put it.

Right click again and choose paste.

You should see the link appear where you want it to be.

Try this link: http://app2.e2ma.net/campaign/31451....47d0a6ea6#News

That's where I found the article. Thanks for the heads up Linda!

Picked up a few things tonight while cruising the MS scene...as usual...:D

First off: PML chart updated at chefartzfrau
http://chefarztfrau.de/?page_id=716

A breakdown of 24 PML cases that I found on an investor board. Sadly, it appears France has joined the party.
8 from Germany,
8 from US
2 from Sweden,
2 from France,
2 from Switzerland,
1 from Spain,
1 from Czech repulblic.

Sex: 9 Males, 15 Females.
Average length of therapy: 25 Months - 18 of the 24 users had Tysabri for more than 24 months

That kind of changes the ratio right there, doesn't it?

Great detective work, River..:)

Thanks for the updates RW. I was just thinking mathematically today now that we have all the numbers.

The average number of infusions among the Tysabri patients is noted on this online list of cases. This is also called the mean. You add up all the numbers together and divide by the amount of numbers. The list states that the mean (average) is 25.

Median is also useful to think about in terms of risk assessment. You arrange the numbers in order and then select the one in the middle.

12, 13, 14, 14, 17, 22, 24, 24, 24, 25, 25, 25, 28, 29, 30, 30, 31, 33, 34, 34, 35, 35, 36, 44

Thus the median is 26.5.

Here the mean (average) and median are fairly close to one another which tells us that it's a good bet that the "risk" of getting PML is somewhere in the mid twenties in terms of infusions (just based on the actual numbers, not what people have taken in the past etc.)

However, if the array of numbers was not so evenly distributed the mean (average) wouldn't tell us as much. For example, imagine the numbers are

12, 12, 12, 12, 44

The mean (average) of these numbers is 18.6. The hypothetical drug company might say "the average risk of this side effect would come at 18.6 months." We like to think in terms of averages a lot. However, the 44 is the outlier and actually this list would tell us that 12 months appears to be a more risky moment when taking this drug.

Anyhow, seeing all the numbers listed out was quite sobering for me. There seem to be an awful lot of cases in Sept. and Oct. The more numbers we have the better risk profile we get. However, I don't want any more numbers to add to this list! :( Hopefully, Biogen/Elan is working on a way to predict more accurately what the mean and median are as part of the risk assessment. I am still planning on going off Tysabri after #23 or 24 unless something radically changes.

It appears that another Tysabri PML patient has recently died. So sad. :(

http://www.everydayhealth.com/blog/t...#comment-22779

I wonder which of the patients this is, based on the list RW posted. Her brother reported her as "patient #14", said she was dx with PML in early Oct, yet it seems she was American ...?:

Cherie

Cherie, I wonder if the brother of the patient was including the first 3 PML cases in clinical trials when he said she was the 14th case. If so that would make her patient #11 on the online list of post- marketing cases--which is someone from the USA.

I wondered about that too, Natalie, but he had said she was dx in Oct, and we knew about the 14th case (including the trial patients) back in late July before Biogen quit giving us updates. :confused:

Cherie

It's believed she is P11 post marketing. Her case came to light after Biogen shut off the PML reports, which is why there were no details listed for her on the chart. I am not sure why there's a discrepancy in when she was diagnosed, and I don't think it really matters anymore.

My prayers go out to her family and I give thanks that her brother cared enough to come out and let people know. It had to be very hard to come and tell what happened to her so soon after the loss of his sister.

The family is permitting the medical community to research her case so that the rest of those of us on Tysabri may benefit, and for that alone we owe them our gratitude and thanks.

Or, he had the number wrong and she was #20 (from the US), who was dx in early Oct.

We did know about #11/#14 US, from the final July 24th report on the Biogen's site:

http://investor.biogenidec.com/phoen...82&p=irol-TPME

But, as you said .... which-ever the patient, it's a sad loss. :(

Cherie