Living With MS

Discussing all aspects of Multiple Sclerosis, various treatments, including accurate information regarding Tysabri.

Wednesday, August 29, 2007

Tysabri Brochure! It is entitled "The STRENGTH To Reach Your High HOPES"

I received in the mail today from Biogen a 21 page Tysabri Brochure that is very well written for prospective Tysabri patients.

The above photo is what the cover of the Tysabri Brochure looks like. In order for you to view this on the Internet, it has been converted to a PDF file:

Of special note is page 11 which states: "Of patients who took Tysabri in the two-year study: 8 out of 10 had no disease progression, or 83% of Tysabri patients had no disease progression at the end of the two-year study compared with 71% of placebo patients".... Whoa!

It includes important safety information and information regarding the TOUCH Prescribing Program, and states that it is important to understand the benefits and risks of Tysabri. Talk to your doctor to learn if it may be right for you, and it goes on to state:

Tysabri positively affects the three components of MS:
  • Frequency of flareups
  • Disease progression
  • MRI brain lesions
Tysabri is different from other MS medicines:
  • It works differently
  • It is taken differently
  • It is available only through the TOUCH Prescribing Program, which focuses on patient safety
I am not sure why I received this Tysabri Brochure which is obviously for "prospective Tysabri patients" considering I've been an actual Tysabri patient for 11 months now - LOL!

If you or your doctor would like further information regarding this brochure it suggests that you contact MSActiveSource at 1-800-456-2255.

I think that this is the first pro-active information I have ever seen written about Tysabri which is easy to understand for patients.

Woooohoooo, it's about time!

Love, Lauren :)
A very proud member of

Monday, August 20, 2007

My Tysabri Diary... Hey now,
MORE GOOD NEWS re: Tysabri!

Here is more news regarding Tysabri demonstrating significant quality-of-life improvements for multiple sclerosis patients... it was just released today, August 20th.

I have provided a link for that data, which is pretty spectacular, but below the link I provided is just a small blurb from Dr. Rudick, Lead Investigator of the study, wooohooo!

20 August 2007
TYSABRI® Demonstrates Significant Health-Related Quality-of-Life Improvements for Multiple Sclerosis Patients in Study Published in Annals of Neurology

"These data showed that patients treated with TYSABRI were more likely to experience statistically important improvement in the quality-of-life measures used to assess meaningful disease improvement or progression. These findings have not been previously observed in clinical studies involving MS patients," said Richard Rudick, MD, Director of the Mellen Center for Multiple Sclerosis Treatment and Research at the Cleveland Clinic, the lead investigator of the study."

Impressive, huh?


Love, Lauren :)
A very proud member of

Sunday, August 19, 2007

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"



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:

Subj: Updating your news information page regarding Tysabri-Priority High
Date: 8/17/2007 5:16:49 PM Pacific Daylight Time
From: LGLBGL2003
Tim Hunt, Vice President
Naomi Aoki, Director
Amy Reilly, Associate Director


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:
), 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 and 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.

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.

Love, Lauren
A very proud member of

Thursday, August 09, 2007

Tysabri, My Tysabri Diary...My 11th Tysabri infusion was yesterday, and boy oh boy - do I feel like Barry Bonds today! (Although I can admit that this feeling is drug enhanced - heehee).

I can still wiggle my toes a little bit this morning and move my feet slightly, my balance is improving, as well as my strength, speech, cognition, and coordination. Even though these improvements for me don't last the full 28 days until my next infusion, when I do feel them again, the feeling is just awesome,

Considering August is the month for the heat of the Summer to kick in, and a majority of MS patients don't do well in the heat (the heat can cause relapses and exacerbations of MS symptoms), I am doing really well at this time of year and my active MS has been abated/controlled outstandingly with the help of Tysabri.

Even though I am not receiving outstanding results like some MS patients are, I am still thrilled with the use of Tysabri because it is preventing further relapses and slowing my disease process down.

I can and will never lose hope for making more improvements (even in the face of reality) with Tysabri because for me, Tysabri = Hope!

Yesterday, during my infusion, a lady in the infusion chair next to mine, struck up a conversation with me regarding autoimmune diseases. She was about my age and receiving Remicade for her rheumatoid arthritis. She is also on methotrexate and prednisone, and has her liver checked regularly. She asked me what medication I was on and for what, so I told her Tysabri for Multiple Sclerosis, and briefly discussed Tysabri, its side effects, its current uses in MS and soon Crohn's disease,
and its prospective uses, as well as the bad rap (PML) it received.

She asked me if she could see the Patient Medication Guide that they give me at each Tysabri infusion, and I said of course (I had at least 10 of them - LOL). She is actually a very lucky patient with RA because it is only in her feet and hands - it is not in her back, neck, or knees (as of yet), but she wants to discuss fully the side effects of Remicade, prednisone, and methotrexate with her doctor.

She also wrote down the Elan website, the MSPatientsForChoice website, and we exchanged phone numbers. Odd, could she actually be starting the journey of becoming her own patient advocate? Ha!

We actually hit it off pretty well because she lives not too far from where I used to live...and we talked of old times there.

Her infusion time is approximately 4 hours every five weeks, and my infusion time (one hour, and then one hour observation time) just flew by this time, and before I knew it, my infusion nurse was unhooking me and telling me that I was free to go!

All in all, it was a wonderful infusion experience, and now I am off to do my PT exercises.

Woooooohoooooo for stabilization of my MS and wooooohooooo for Tysabri!

Have a great week everyone,

Love, Lauren :)

A very proud member of

Sunday, August 05, 2007

My Tysabri Diary... Hi everybody... we have a
new feature on MSpatientsforchoice which is a forum based link for the community (patient, family, friends, caregiver, and so on) to gather together, introduce themselves, ask questions about MS, the different MS drugs, or just talk about their MS, etc. The link ("Community") is listed on the homepage of our website at the top. The newest post there was from a lovely lady who was researching MS information for her friend that was just diagnosed with MS.

It's brand-new, and
wow, we are already getting new people every day signing up and posting there! If you are interested in reading the information posted there, want to ask questions, or just share your MS experiences, go to:

I go for my 11th Tysabri infusion on Wednesday the 8th, and boy am I feeling I need it! I had to remember to ask my caregiver to pick up some more Claritin the next time he was at the market (I take a Claritin about 30 minutes before each of my infusions to eliminate and/or reduce any potential side effects), which so far have been NONE! Woooohoooo!

Now if I can remember that I needed more Claritin, Tysabri must be having a positive effect on my short-term memory loss!!! (Heehee)

More postings here after Wednesday....until then,


Love, Lauren :)

A very
proud member of

Wednesday, August 01, 2007

My Tysabri Diary...
Wooooohoooooo! Here is another WIN for patients! Oh I am just so happy for the suffering CD patients :)

Joint FDA Advisory Committee Recommends Approval of TYSABRI(R) for the Treatment of Moderate to Severe Crohn´s Disease 01/08/2007

Elan Corporation, plc (NYSE: ELN) and Biogen Biogen Idec (NASDAQ: BIIB) announced today that the Gastrointestinal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee of the U.S. Food and Drug Administration (FDA) voted 12 in favor to 3 opposed, with 2 abstaining, to recommend approval of TYSABRI(R) (natalizumab) as a treatment for moderate-to-severe Crohn´s disease in patients who have failed or cannot tolerate available therapies.

The recommendation is advisory to the FDA, and the agency is not bound by this recommendation. Elan and Biogen Idec will continue to work closely with the FDA in the weeks ahead with the goal of making TYSABRI available for the treatment of appropriate patients with Crohn´s disease. Discussions with the FDA will include adapting the existing TYSABRI risk management plan and addressing any other issues raised during the Committees´ deliberations on this new indication.

I believe the FDA renders its final decision in October 2007.


Love, Lauren
A very proud member of