Living With MS

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

Sunday, May 06, 2007

My Tysabri Diary...

I find it almost laughable that even in spite of the recent glowing reports of Tysabri's Efficacy beyond 3 years, and Continuing Safety Data, the media just can't get their facts right when reporting on Tysabri.

For example, here is a letter I sent to the WSJ reporter Ms. Jennifer Corbett-Dooren and all their editors today correcting her (even though her article was pretty good and her address reads - the full article is at the end of my post here). Feel free to submit your comments to them too!

Subject: Your Article of 5/3/07 re: Tysabri - Priority: High
Date: Sat, 5 May 2007 12:21 PM

Ms. Corbett-Dooren:

Thank you for your excellent Article: "Biogen, Elan Get No New Reports Of Brain Infection From Tysabri". However, I would like to point out one very important inaccuracy in your article. You wrote: "The FDA recommends the drug be used only after other treatments fail for the relapsing-remitting form of MS." and this is completely incorrect.

Tysabri is a first line and/or second line defense against MS...Tysabri is for patients with relapsing forms of MS that generally have not responded to, or cannot tolerate, other MS treatments.

What this means is that Tysabri is a first line (like the ABCRs) and/or a second line defense/treatment for MS. The phrase "cannot tolerate" can be interpreted by the treating physican to include their "needle-phobic" patients...or patients with "aggressive forms of relapsing MS"... , therefore, the patient does not necessarily have to fail one med first in order to have Tysabri.

Pursuant to Dr. Katz and Dr. Temple of the FDA, they explained to the public in a Conference Call shortly after their Advisory Committee hearings in March 2006 that the FDA's decision/language above was purposely left open and left up to the treating physican.

See the FDA statement: "The Food and Drug Administration (FDA) today approved an application for resumed marketing of Tysabri (natalizumab).. Tysabri is indicated for use as monotherapy, because we don't know enough about how its use with other immune modifying drugs could impact risk. It is also meant for patients who have not responded adequately to, or cannot tolerate, other treatments for MS." .

Tysabri's FDA approved 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." (which is almost identical to the ABCRs).

I happen to know a few Tysabri users that are using Tysabri as a first line therapy for their MS. It was their treating neuro's decision to rx it as first line for them and they were all too happy to start Tysabri.

Furthermore, "relapsing" forms of MS include Relapsing/Remitting (RRMS), Secondary Progressive with Relapses (SPMS)*, and Progressive Relapsing (PRMS). These are all forms of MS which are in the inflammatory stage.

Patients with Primary Progressive (PPMS) and Secondary Progressive without Relapses (SPMS)* are in the demyelinating stage of their MS and are ineligible for Tysabri at this time.

*SPMS has two categories: Initially, MS patients with RRMS progress to SPMS With relapses (still eligible for Tysabri), and then they progress to SPMS Without relapses (ineligble for Tysabri). Approximately 50% of MS patients are now SPMS with relapses.

This distinction is important as Tysabri has been proven to stop/slow the disease process down, and prevent further relapses with their accumulating disabilities.

I am a 52 yr. old MS patient, diagnosed with MS for 31+years, and I testified via videotape at the FDA AC hearings in March 2006. I am also classified as SPMS With Relapses, and have had 7 Tysabri infusions since 10/06. I was having relapses approx. once a month prior to my Tysabri therapy, and subsequently, I have not had one relapse nor any disease progression since 10/06 and my MS is now stable.

Ms. Dooren, please consider issuing a correction to your article as indicated above, so that the MS community will be better informed, especially the currently eligible Tysabri MS patients that are suffering disease progression and further debilitating relapses (some of which will be left with permanent damage) from erroneously believing they are required to try and fail the older generation DMDs first, before allowed Tysabri (which might be too late for the many that will become ineligible for Tysabri at that time as their disease will have progressed to a non-relapsing form of MS).

Give them their hope back with the truth about Tysabri - you'd be surprised how many MS patients and Neurologists your "financial" article has reached. In spite of the fact that many of us are physically disabled now, our minds are still sharp and we enjoy reading well written articles from the world renowned WSJ.

Thank you for your time, attention, and consideration regarding this matter.

Respectfully submitted,

Lauren Roberts (MS patient & Tysabri user)


Full Article:
Biogen, Elan Get No New Reports Of Brain Infection From Tysabri
By JENNIFER CORBETT DOOREN May 3, 2007 8:20 a.m.

WASHINGTON -- There have been no additional reports of a serious brain infection known as progressive multifocal leukoencephalopathy, or PML, among patients taking the multiple-sclerosis drug Tysabri, the drug's makers said Thursday.

Biogen Idec Inc. and Elan Corp., also said there were no reports of other "serious opportunistic infections," as of April 23. The companies released the first safety update involving Tysabri since the drug was allowed back in the U.S. market last June. The data was released at the American Academy of Neurology's annual meeting on Boston.

The drug was pulled off the U.S. market in February 2005 after two patients developed PML and one died. A third patient was later discovered to have PML and also died.

Tysabri is currently under a restricted distribution system and a program that allows the companies to track potential safety problems with the drug.

The companies said about 12,500 patients world-wide have been prescribed Tysabri, including about 6,600 patients in the U.S. currently who are on therapy.

The companies said about 10,000 U.S. patients and 1,500 physicians have enrolled in the restricted distribution program known as Touch. Tysabri is administered as an infusion in a clinic. The FDA recommends the drug be used only after other treatments fail for the relapsing-remitting form of MS. MS is a progressive disease that involves damage to nerves controlling muscles and vision, and affects about 400,000 Americans.

Before Tysabri can be started, patients must undergo a magnetic resonance imaging or MRI scan to differentiate potential future multiple sclerosis symptoms from PML. Patients would then be evaluated at three months, six months and then every six months after that. The status of those evaluations must be reported by doctors to Biogen Idec.

Biogen and Elan also issued an update on an extension study of an original two-year study that involved 942 patients. That study, known as Affirm, showed Tysabri cut the annual risk of relapse by 67% compared with patients on placebo, or a fake drug. The extension study includes 531 patients, 250 who have received almost three years of therapy.

The companies said, the annualized relapse rate for patients treated with Tysabri over the three-year period was 0.23, which translates into an average relapse rate of one relapse every 4.3 years. Over the three-year treatment period, the relapse rate averaged 0.27 during the first year; 0.20 during the second year; and 0.15 during the third year.

Write to Jennifer Corbett Dooren at

That's all for now everyone. Have a terrific upcoming week. :)

Love, Lauren
A very proud member of


  • At 7:28 PM, Anonymous Zee said…

    Dow Jones and the Wall Street Journal are very closely linked - DJ content is often posted in the WSJ. WSJ content is frequently sent to Dow Jones, which is then distributed to a number of newspapers and other media worldwide. (I work in media relations and we deal w/ DJ and WSJ regularly. :) Anyway, this article likely has reached much farther than the WSJ's audience (which is still considerable.)

    Despite my dear mother's rather loud objections, I'm planning to ask my neuro to be put on Tysabri when I see him in July if my MRI shows signs of continued MS activity. As you've said (and I agree), what are we waiting for - more disease progression? The Avonex doesn't appear to be helping and shoot - if there's a drug that's twice as effective, why wouldn't I want to be on that? :)

    Anyway, thanks for being such an advocate for this drug and helping to ensure that accurate information is disseminated!

  • At 12:08 PM, Blogger Lauren said…

    Thanks so much Zee for your comment... sorry for the late reply.

    I am pleased to hear that you were going to be discussing Tysabri with your neurologist. Hopefully your neurologist is Touch Certified.

    Let me know the outcome of your appointment, please?

    Zee, can you contact me via e-mail at, to discuss DJ and WSJ and the upcoming FDA AC meeting Re: Tysabri for CD on 7/31 please?

    I look forward to hearing from you, and again, thanks so much for your comments on my blog.

    Lauren :)


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