I heard through the grapevine that they will soon be reporting the PML cases on the website again. Gee, I wonder why? 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? Just thinking out loud, don't mind me.

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!)

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?

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.

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.

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 ...

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
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