My Tysabri Diary...,

Hi everyone, I just returned home a little while ago from my 25th Tysabri infusion... once again, no problems, no side effects, no adverse reactions, and no problems with the infusion... my nurse was able to "stick me" with just one jab, yay!

When I asked how the other Tysabri patients were doing, I was told "just fine", no problems there either and no one was concerned about the two new cases of PML in Europe.


So other than that, I have nothing new to report (which is a good thing).

I did want to share an e-mail that I sent to the editor in chief of the AAN recent publication regarding the new guideline that their authors published yesterday (I've received no reply from them as yet, and I really don't expect one either)...., they kind of pi$$ed me off (oops).

I'm off to have an early dinner of pizza and mudslides, and then turn in early... have a wonderful evening everyone,

((((hugs))))
Love, Lauren :)

Subj: AAN's Publication for Use of Natalizumab dated 9/2/08 Date: 9/2/2008 3:22:43 PM Pacific Daylight Time From: LGLBGL2003 To: editorinchief@aan.com

Gentlepersons,

I just reviewed your publication of the New Guideline Published on the Use of Natalizumab for MS:

http://www.aan.com/news/index.cfm?event=read&article_id=6024&page=72.45.45

From a review of the publication above, strong exception is taking to the following language used:

"it is recommended that natalizumab be reserved for use in selected patients with relapsing-remitting disease who have failed other therapies either through continued disease activity or medication intolerance, or who have a particularly aggressive initial disease course.".

This recommendation is in direct conflict with the FDA approved Tysabri label and which furthermore is in direct conflict with the FDA memorandum which previously issued, stating in part: "FDA would like to clarify to the reader that the MS indication for Tysabri was carefully written by FDA and the Sponsor to indicate that its use is generally recommendedfor patients who have had an inadequate response to, or are unable totolerate, alternative multiple sclerosis therapies (e.g., as second-line therapy). However, the indication statement does not explicitly preclude the possibility of first-line therapy in some MS patients as part of the approved use. FDA recognizes that the health care provider needs to consider its use based on the unique circumstances of each patient.

http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4313b1-02-FDA-Errata.pdf ".

In addition, Tysabri is to be used for "relapsing forms" of MS, which include Relapsing-Remitting, Progressive Relapsing, and Secondary Progressive with relapses. The authors of the article indicate that it is for relapsing-remitting disease, which is completely incorrect. The Tysabri label states: "TYSABRI® is indicated as monotherapy for the treatment of patients with relapsing forms of multiple sclerosis to delay the accumulation of physical disability and reduce the frequency of clinical exacerbations.".

While I understand that the AAN is a medical specialty group and as such, does not preclude recommending a narrower scope of Tysabri's use, what in fact the AAN authors of this article are doing is condemning a wide variety of MS patients to suffer additional relapses and disease progression needlessly by relegating treatment first with one of the ABCRs, not to mention a very large patient population of noncompliance to the ABCRs treatment regimes due to their side effects and injection site reactions. Furthermore, said language will make it extremely difficult for insurance companies to provide approval for the use of Tysabri in these patients and as a first-line therapy when first-line therapy use is clearly approved by the FDA. The authors of said article should take into consideration that the health care provider needs to consider its use based on the unique circumstances of each patient.

Your authors begin by commenting: "Strong evidence suggests that natalizumab reduces disease activity and severity in people with relapsing MS by both clinical and MRI measures."..., would it not behoove MS patients to begin treatment as soon as possible with Tysabri in order to achieve these results?

Lastly, your authors state that: "strong evidence suggests an increased risk of developing PML in patients receiving combination therapy with interferon (IFN) and natalizumab"..., considering Tysabri can only be prescribed as a monotherapy to non-immunocompromised MS patients pursuant to the FDA approved label and accompanying RiskMAP, there is no increased risk of developing PML.

As a Tysabri patient for more than two years and a MS patient for more than 32 years, I really must object to the language used by your authors in this publication, and respectfully request a clarified and corrected publication issue which will help truthfully guide physicians when treating their MS patients rather than mislead them into allowing their MS patients to continue suffering possible permanent damage needlessly due to the AAN's authors current language.

I look forward to your prompt reply.

Respectfully submitted,

Lauren Roberts