My Tysabri Diary...wonderful news!

TYSABRI® RECEIVES APPROVAL IN NEW ZEALAND

TYSABRI® RECEIVES APPROVAL IN NEW ZEALAND FOR THE

TREATMENT OF RELAPSING REMITTING MULTIPLE SCLEROSIS

Auckland, New Zealand – 27th September 2007 – Biogen Idec NZ Limited and Elan Corporation, plc (NYSE: ELN) today announced that TYSABRI® (natalizumab 300mg) had been registered as monotherapy for the treatment of patients with relapsing remitting multiple sclerosis (MS) to delay the progression of physical disability and to reduce the frequency of relapse.

The registration was based on a submission that included TYSABRI two-year Phase III clinical trial data and findings from a comprehensive safety evaluation. An estimated 4000 people in New Zealand are affected by MS.

“Today marks an important step forward for the New Zealand MS patient community,” said Eric Fidelin, Managing Director of Biogen Idec New Zealand. “TYSABRI represents one of the most significant advances in MS treatment in nearly 10 years and provides patients living with this disabling disease an important new therapeutic choice.”

###

ABOUT TYSABRI

TYSABRI is a treatment approved for relapsing forms of MS in the United States and relapsing-remitting MS in the European Union. According to data that have been published in the New England Journal of Medicine, after two years, TYSABRI treatment led to a 68% relative reduction (p<0.001)>

Oh my gosh, I'm so happy for them....YeeeeeeeHaaaaaaaw!

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

My Tysabri Diary...Yesterday September 26, 2007 I listened to the national teleconference presented by MSActiveSource Re: Tysabri and the speaker was Dr. Heidi Crayton...here are a few of the notes that I took and if they happen to replay the telecast, I'll post the link for it. When I listened to the conference yesterday, I called 1-866-955-9999 to register for it and then I was given number 1-800-399-5094 and the code 13218633 to listen to it, so I am not sure if it is still available, but here are my notes: (remember these are her opinions, not mine):

She indicated that there are over 16,000 patients worldwide currently on Tysabri therapy, with more doctors and more patients feeling comfortable using Tysabri. More and more patients are asking to be placed on Tysabri therapy, especially because the infusion starts to work within weeks, as opposed to the ABCRs which can take up to months for them to start working. She said that most of these Tysabri patients start to feel better after their Tysabri infusions, i.e. she attributed this to the patients feeling they had a better Quality of Life.

She said she has had many success stories using Tysabri, and usually patients feel its effectiveness after the second infusion or approximately 6 weeks from the first infusion. She does not normally pretreat, but if she does, she use an antihistamine such as Claritin because Claritin does not make the patient drowsy.

She indicated that the patient's MRI results are good also, specifically in relapsing remitting and secondary progressive MS. Tysabri shows 67% efficacy (two thirds) over the ABCRs which only show a one third efficacy. Avonex at Rebif are the only injectables which show a reduction in relapses.

Regarding the patient's MRIs, Tysabri shows 76% reduction in black holes, which the ABCRs cannot address.

When discussing PML, she indicated that it was caused by Avonex plus Tysabri, and not Tysabri alone (she was adamant about this). She disagreed with the risk of 0.1% and stated it was actually much lower than that (she believed) when used as a monotherapy.

She went on to discuss the Touch program, indicating that patients are watched very closely and their health is monitored once a month because of the Touch program. All patients receiving Tysabri are watched better than patients that inject any of the ABCRs, so in actuality, the patient receives excellent care when it comes to their therapy.

She indicated that Tysabri was for relapsing forms of MS, which include relapsing remitting, progressive relapsing, and secondary progressive with relapses, which can be used as either a first line or second line therapy.

She discussed the fact that all of the treatments for MS have risks, including liver damage and depression from the interferons.

When discussing the options of Novantrone versus Tysabri, she indicated that she was very happy to have the option of using Tysabri over Novantrone, especially in younger patients because Novantrone causes infertility. She also indicated that Novantrone has risks of its own including cardio risks, permanent heart damage (to the heart muscle), leukemia, etc.

She also discussed Tysabri's mechanism of action against MS, but my numb hands were too tired to try to write anymore (besides, I could hardly read what I wrote to begin with- LOL!).

All in all, this was an excellent, informative program and I hope that many MS patients were able to listen to it.

Wooooohoooooo, it's about time!

Take care everyone...,

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

My Tysabri Diary...

I just returned from my one year follow up appointment with my neurologist, and I am pleased to report that she was "delighted" with my progress (those were her words).

What she was most happy about is that she did not feel I was progressing in my disease, and that what I thought was a mild relapse in early May of this year...was really not a relapse at all but a pseudo-exacerbation when I was so upset over Mina's death, soooooooo, no relapses in a year and no disease progression = WOOOHOOO! She also did not feel that a follow-up MRI was necessary, as she only saw good things when it came to my examination (strength, coordination, balance, etc.), and these were her findings, not my subjective opinions as relayed to her. She also said that if I wanted another MRI, she would order one, but she was trying to save me from the ordeal.

I guess because I live with this disease, and I struggle with its daily challenges, I initially did not think that she would be delighted. I am of course happy that I am able to continue with my Tysabri infusions, I just thought that she was going to be more disappointed that I hadn't made more significant improvements in my symptoms (actually I had been more disappointed than anyone, because I had only felt these minor improvements for about three weeks after my infusions - however never giving up hope and trying to maintain a positive attitude)...but not after this appointment, I'm flying!

She does want me to continue with my physical therapy exercises, and I wowed her with what I had accomplished to date (especially my improved strength). She does however want me to work on my "hip flexors" (I think that's what she called them) which enables the foot/leg to be lifted upright (aka vertically from a sitting position), and which enables one to take a step/walk. She wants my caregiver and I to be trained by the physical therapists in the exercises that will best help me in this area? We need to follow up with Kaiser in this regard.

She also said that of the Tysabri patients that she is aware of within her practice (that being in So. Calif. Kaiser), she believes that I am doing better than most of those patients. When I asked her how many patients she was talking about, she said roughly 10 to 15, but she has not asked the different neurologists throughout Kaiser, as she mainly stays focused on me as her most challenging patient - LOL.

Now I am off to do more grueling physical therapy exercises... no pain, no gain - right?

Have a great day everyone.

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

Tysabri:

To the MS patients that are confused over the recent article that was released by HealthDay (specifically from "reporter" Amanda Gardner), here was my e-mail reply to HealthDay and I suggest that anyone else concerned about these anti-Tysabri biased reports from her also e-mail HealthDay at the address listed below.

These reports are outrageously slanted, ugh!:

Subj: Article written by Amanda Gardner 9/13: Priority High Date: 9/14/2007 2:27:15 PM Pacific Daylight Time From: LGLBGL2003 To: editors@healthday.com

Gentlepersons:

I am writing you today in reference to the article written by Healthday News Reporter Amanda Gardner dated September 13th, 2007 http://news.yahoo.com/s/hsn/20070913/hl_hsn/stoppingtysabrimayworsenms as well as the article http://www.sciencedaily.com/releases/2007/09/070912163524.htm which had several inaccuracies.

Specifically, with regard to the September 13 article, she incorrectly states: "But the drug has a checkered past. It first received U.S. Food and Drug Administration approval in November 2004, only to be pulled from the market three months later after several patients in clinical trials developed a rare but deadly viral infection of the brain called progressive multifocal leukoencephalopathy"

The medication that she's referencing, Tysabri/Natalizumab, was not pulled from the market (which implies the FDA required it to be pulled). Tysabri was voluntarily removed from the market by the manufacturer Biogen IDEC, until a comprehensive and thorough safety review had been conducted, which took more than a year. Furthermore, "several" patients in the clinical trials did not develop progressive multi-focal leukoencephalopathy. Three patients developed PML, wherein two of the patients had compromised immune systems with a drug interaction/combination Avonex therapy, and the third patient (a Crohn's patient) that also had a drug interaction due to having a six year history of Azathioprine use, which rendered him severely immune compromised.

With regard to Ms. Gardner's opening 'sensationalized' statement: "People suffering from multiple sclerosis who stopped taking the controversial drug Tysabri experienced a resurgence of brain lesions associated with their disease, researchers report.", MS patients are now confused and scared of Tysabri, and she has done a terrible disservice to these MS patients that need Tysabri. Since September 13th, I have received several e-mails from distressed MS patients after reading her articles.

Then towards the end of her "rebound" article, she briefly mentions ""Virtually all of the high-rebound figure came from the group that had a mean duration of therapy of only two months. I think that's relatively reassuring for the drug," Richert said."

While I understand that she was quoting the original report from Online Neurology, her article was extremely misleading in that:

It takes approximately 2 months for Tysabri to fully leave the body;

Far too much weight is being given to a the "observational" study which involved a mere 21 patients at this ONE facility;

Was this just a problem at this one site or a universal finding?

Were any of female participants post-pregnancy?

Late term pregnancy is protective from relapses, and then post-pregnancy has a higher than usual rate of relapse. That is why many MS patients choose to go
back on therapy quickly after pregnanacy;

Were any of the participants in the original monotherapy trials [Affirm]?

Were any of the participants in the combination trials [Sentinel]?

The larger question is whether the patients were placed on another agent or just withdrawn from Tysabri? If they were not placed on another medicine within 1 month of their last Tysabri dose, then that could be the problem;

If this site washed out for months and other sites switched quickly to Tysabri, there may not be a big issue;

Also of note, rebound was noted in the rodent EAE model when oral antiVLA-4 agents (act the same as Tysabri) were used. The average active study patient was on Tysabri 30 months or so and the placebo switched patient 6 months or so. Their finding of a difference between Tysabri/Tysabri and placebo/Tysabri patients could have a simple explanation;

Mechanistically, one can think that there are many myelin reactive T and B cells floating around the periphery (blood and lymphoid tissues) unable to get into the brain to expand and cause a plaque while a patient is on Tysabri. As Tysabri goes away over 2 months, the surviving cells can come into the brain. After a long period of Tysabri, there will be fewer living activated cells in the periphery than there would be after a short period, so less rebound could occur;

A larger controlled study previously addressed this issue of "rebound effect", which completely contradicts the smaller, non-controlled study. Obviously this larger multi-site study (incidentally in a population similar to the placebo/Tysabri group) has much more weight than a single observational site study with 1/10th the number of patients that were involved in the extension study where compiled data was from every site (hundreds of patients).
The full article can be found at: http://www.emea.europa.eu/humandocs/PDFs/EPAR/tysabri/H-603-en6.pdf.

As a MS patient for over 31 years, and current Tysabri patient, it is my belief that when discussing these kind of "sensationalistic" findings, one has to be very careful as these kinds of reports written by Ms. Gardner are "sketchy" at best, and can/are causing needless worry and panic in the MS patient community, and indeed in the Crohn's patient community as well.

It is difficult enough as it is that we have to deal with an autoimmune disease (which is chronic and progressive in nature; which has very few effective treatment options-posing a very real and tremendous unmet medical for a disease which we must fight daily; including the social stigmas attached thereto), but we now have to deal with articles such as Ms. Gardner's?

For Ms. Gardner to just "gloss over" the realities of suffering patients with partial and misleading facts as I have indicated above, rather than completely and fully emphasizing them at the forefront of her articles, ultimately renders her articles rather misleading and egregious (which includes HealthDay).

It would be appreciated if a correction statement were added to these articles and reprinted today, which will obviously calm the fears of many patients who are reading these articles written by Ms. Gardner.

Very truly yours,

Lauren Roberts
(MS patient and Tysabri user)

***
Maybe if enough people e-mailed HealthDay, they will issue a corrected statement.

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

Tysabri vs. Avonex, Betaseron, and Rebif (Interferon Beta)...Is your Interferon Beta therapy as safe as you really think it is???

Just take a look at what I found, and hold on to your chair because you might fall out of it!

http://www.rxlist.com/script/main/art.asp?articlekey=83785



From 1998-2005, the eight-year period covered, INTERFERON BETA was ranked #8 on the list of "suspect drugs" causing death with a WHOPPING (to me, anyway) 1178 reported.

It also ranked #4 in the list of suspect drugs causing death, disability or having other serious outcomes combined for a total of 9498 SAEs (Serious Adverse Events) reported.

Most Frequent Suspect Drugs in Death and Serious Nonfatal Outcomes, 1998-2005
Drug Name-Rank/Deaths-Drug Class Death: Most Frequent Suspect Drugs in Death
and Serious Nonfatal Outcomes, 1998-2005
Drug Name Rank/Deaths Drug Class
Death outcome
Oxycodone 1/5548 Opioid analgesic
Fentanyl 2/3545 Opioid analgesic
Clozapine 3/3277 Antipsychotic
Morphine 4/1616 Opioid analgesic
Acetaminophen 5/1393 Analgesic
Methadone 6/1258 Opioid analgesic
Infliximab 7/1228 DMARD
Interferon beta 8/1178 Immunomodulator
Risperidone 9/1093 Antipsychotic
Etanercept 10/1034 DMARD
Paclitaxel 11/1033 Antineoplastic
Acetaminophen-hydrocodone 12/1032 Combination analgesic
Olanzapine 13/1005 Antipsychotic
Rofecoxib 14/932 NSAID
Paroxetine 15/850 Antidepressant

Disability or other serious outcome:
Estrogens 1/11 514 Hormone
Insulin 2/9597 Hormone
Infliximab 3/8754 DMARD
Interferon beta 4/8320 Immunomodulator
Paroxetine 5/8095 Antidepressant
Rofecoxib 6/7766 NSAID
Warfarin 7/6250 Anticoagulant
Atorvastatin 8/6022 HMG-CoA reductase
inhibitor
Etanercept 9/5586 DMARD
Celecoxib 10/4822 NSAID
Phentermine 11/4607 Antiobesity
Clozapine 12/4388 Antipsychotic
Interferon alfa 13/4162 Immunomodulator
Simvastatin 14/3885 HMG-CoA reductase
inhibitor
Venlafaxine 15/3688 Antidepressant

(I will just list the SAEs #'s for Interferon Beta) Drugs With 500 or More Reported Deaths and Serious Adverse Drug Events in Any Year
Interferon beta . . . Combined Total 9498 ...'98-349, '99-392, '00-769, '01-777, '02-1032, '03-1240, '04-2210, '05-2729


As I sit here typing this, fully aware of the serious nature of PML (btw, there was no Natalizumab/TYSABRI mentioned in the article despite covering through 2005), I'm thinking, let's see, it's OK to market a class of drugs to treat MS (i.e., INTERFERON BETA) that has caused over 1000 deaths and over 8000 SAEs over an 8-year period, yet, we have a new drug for MS (i.e., TYSABRI) that's twice as effective as the aforementioned drug class, and we encounter only 2 cases of PML (1 fatality in a patient who's diagnosis of MS was suspect at the time of autopsy) that can't even be attributed to Tysabri in and of itself, and this constituted sufficient grounds for having that drug withdrawn from the market for 18 months, as well as restrictions being placed on its use when re-released??? And MS patients are afraid to take Tysabri? And neurologists are afraid to prescribe Tysabri?.

What's wrong with this picture?

Here is the Moore et al., Archives of Internal Medicine, abstract below:


Serious Adverse Drug Events Reported to the Food and Drug Administration, 1998-2005

Thomas J. Moore, AB; Michael R. Cohen, RPh, MS, ScD; Curt D. Furberg, MD, PhD

Arch Intern Med. 2007;167:1752-1759.

ABSTRACT

Background The US Food and Drug Administration has operated the Adverse Event Reporting System since 1998. It collects all voluntary reports of adverse drug events submitted directly to the agency or through drug manufacturers.

Methods Using extracts published for research use, we analyzed all serious adverse drug events and medication errors in the United States reported to the Food and Drug Administration from 1998 through 2005.

Results From 1998 through 2005, reported serious adverse drug events increased 2.6-fold from 34 966 to 89 842, and fatal adverse drug events increased 2.7-fold from 5519 to 15 107. Reported serious events increased 4 times faster than the total number of outpatient prescriptions during the period. In a subset of drugs with 500 or more cases reported in any year, drugs related to safety withdrawals accounted for 26% of reported events in that group in 1999, declining to less than 1% in 2005. For 13 new biotechnology products, reported serious events grew 15.8-fold, from 580 reported in 1998 to 9181 in 2005. The increase was influenced by relatively few drugs: 298 of the 1489 drugs identified (20%) accounted for 407 394 of the 467 809 events (87%).

Conclusions These data show a marked increase in reported deaths and serious injuries associated with drug therapy over the study period. The results highlight the importance of this public health problem and illustrate the need for improved systems to manage the risks of prescription drugs.

I do hope that MS patients will fully arm themselves with this information if they are on either Avonex, Betaseron, or Rebif and are afraid of Tysabri... the numbers speak for themselves.


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

My Tysabri Diary... I had my 12th Tysabri infusion yesterday, September 5th. I was pretty tired the day of my infusion, so when I got home I took a very long nap.

The temperatures yesterday reached 104° and we hit rush hour traffic going to and from the infusion center, so I was pretty wiped out when we got home.

This being the next day however, I can feel my strength returning again and oh my goodness, it's such a wonderful feeling (better than any steroid treatment I ever had!). Woooohoooo!

Has it really been a year already? Time really flies when one has hope! My balance issues, my slurred speech issues, and my optic neuritis issues are slowly but surely improving with each infusion that I receive.

I am going to enjoy the next three weeks to the best of my ability, and continue to fight my MS with the most effective therapy that we have to date.

Tysabri continues to instill hope in me, and hope for others as well, as we battle this disease on the front lines with Tysabri!

Oh and by the way, I have received a lot of inquiries and e-mails regarding the Tysabri Brochure that I have been posting wherever I can so that other MS patients can see it as well, double Woooooohoooooo!

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