My Tysabri Diary...hi everyone, I have a lot to say today about Tysabri.

1) I am posting a FDA Memorandum that clarifies any erroneous misinterpretation by both doctors and patients regarding Tysabri's use (it IS a first-line AND/OR second-line therapy for MS)...woohooo (laughing at myself);

2) I am posting an e-mail that I sent to Biogen's public affairs department due to the fact that Biogen has not even updated their Tysabri Central Information Center page in over a year, and yet they show at the bottom of that page the year 2007! Ugh! I am becoming more and more disgusted with Biogen as each and every day passes.

Please feel free to e-mail their public affairs department as well (you can send it anonymously if you prefer and their e-mail address shows below in my e-mail to them) if you are disgusted too with them. I am sure that a large percentage of why they are doing to this (purposefully keeping MS patients and neurologists in the dark regarding Tysabri) is so that they can keep promoting Avonex sales, either that or they're just plain lazy.

"Clarification Memorandum by the FDA regarding Tysabri's use as a first-line AND/OR second-line therapy for MS patients"

MEMORANDUM DEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH SERVICE

FOOD AND DRUG ADMINISTRATION
CENTER FOR DRUG EVALUATION AND RESEARCH

SUBJECT: Errata to FDA Background document for the Tysabri (natalizumab) Advisory Committee on July 31, 2007

In the reviews, Tab 1 (FDA Clinical Review) and Tab 2 (Office of Surveillance and Epidemiology Review), it was stated that the MS population to receive Tysabri should be those “unable to tolerate or with an inadequate response to other available MS therapies” and it was stated that the indication was revised to “relegate it [Tysabri] to a second-line therapy for relapsing-remitting MS.”

The indication in the current label states “…Tysabri is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, alternative multiple sclerosis therapies.”

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 recommended for 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.

(FDA Memorandum above which is in PDF format: http://tinyurl.com/2989yp)

Subj: Updating your news information page regarding Tysabri-Priority High Date: 8/17/2007 5:16:49 PM Pacific Daylight Time From: LGLBGL2003 To: public.affairs@biogenidec.com CC: chris.burns@elan.com, Kmartin@elan.com

Tim Hunt, Vice President
Naomi Aoki, Director
Amy Reilly, Associate Director

Gentlepersons:

As a MS patient for 31 plus years, former Avonex user, and current Tysabri patient that has had 11 infusions so far, upon reviewing your full news information page (Natalizumab) Information Center regarding Tysabri (see: http://www.biogenidec.com/site/news-and-media.html?pr_id=../site/tysabriinfo_letter5.htm), your information posted there is woefully outdated (July 2006), considering as of mid-July 2007, Tysabri has been back on the market for over a year, with approximately 14,000 plus patients currently receiving Tysabri therapy with not one single case of PML or other opportunistic infections reported in these MS patients being treated with Tysabri since that time.

Furthermore, it appears at the bottom of that page that your website is currently updated (2007 Biogen Idec).

While I do understand that all communications with patients, including changes to patient-oriented websites (such as MSActiveSource.com and Tysabri.com) need to be approved in advance by the FDA, Biogen's failure to even update their Tysabri Information Center page in over a year is particularly egregious.

By failing to keep potential prescribing neurologists and potential MS patients/users updated with the most current information regarding Tysabri for MS, Biogen Idec is providing a terrible disservice to the MS community, as well as allowing for a MS patient currently on one of the lesser efficacious ABCRs to possibly/probably suffer a relapse with resulting disability, which could be permanent.

In addition, while I also understand that Biogen has been conducting Tysabri seminars throughout portions of the US, many disabled MS patients who cannot travel, as well as busy neurologists, can and should be updated through your website (specifically, Biogen's homepage Letter to the MS Community, and your Natalizumab/Tysabri Information Center homepage Letter to the MS Community).

Your immediate attention to the above, and reply to this e-mail, is appreciated.

Sincerely, Lauren R.

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Maybe someone over at Biogen will wake up and smell the complaints that will be coming in once others start to bombard them with their own e-mails that discussed the above.

(((hugs)))
Love, Lauren
A very proud member of www.MSpatientsforchoice.org