Tysabri info

A board to discuss the newly-released drug Tysabri, (formerly known as Antegren) as a treatment for Multiple Sclerosis

Re: stock article with GOOD ms patient info

Postby HarryZ » Wed Jan 04, 2006 6:52 pm

Poetriri,

Just as I predicted, the press releases in the financial world will start to surface now and continue on a planned basis until Tysabri is conditionally re-approved. It's not about MS patients' health...it's all about the $$$$.

Kam, who has a background as an entrepreneur and manager in the medical products industry, says two factors that should help Tysabri are that no patients taking just Tysabri came down with PML, and that existing drugs to fight multiple sclerosis don’t work for 25% of MS patients. For those 100,000 or so patients in the U.S., Kam says Tysabri can greatly improve their quality of life.


I wonder how Kam knows that PML isn't such a potential problem....not even the researchers have the answers to this as yet. And the CRABs don't work for about 66% of patients, not 25%!

“Wall Street is beginning to agree that Tysabri will return, but Merril Lynch and Citibank both recently reiterated their sell recommendations, both citing their belief that Tysabri will be hard to sell to physicians and MS patients until the risks of PML are better understood,” says Kam


Now that's interesting.... he states that the unknown risks of PML will cause a hard sell to physicians. But later in the press release he says that since the risk of getting PML are only .01%, ( supposed data from Biogen/Elan based on their 3000 patients) it's well worth it since the deaths from aspirin are .02% ( data from millions of users) Hmmm...I wonder what number of deaths and other infectious complications we may see from Tysabri when the number of users starts to skyrocket?

“One of the common side effects of competing drugs is constant flu-like symptoms. If you caught the flu this winter, you know how miserable it can be. Imagine how it would affect your life if you had the flu all the time. That is what life is like for many of these 300,000 MS patients. An important fact I noted from the clinical trial data and interviews with MS patients is that Tysabri does not seem to give MS patients these same flu-like symptoms.


I'm sure the competition won't be impressed with comments like this about their drugs. The interferon drug makers have virtually ignored this common side effect about their products for years as they have raked in billions of dollars selling them.

I have no qualms about the MS patient deciding whether he/she will use Tysabri. That's their right. But some of the rationalization that the money experts are going to spew out in the next few months will be hard to swallow!

Harry
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Postby amelia » Thu Jan 05, 2006 9:41 am

As I have stated before, if Gary, my hubby, can have a couple of years of QUALITY of life it beats the heck out of the quality of life he is looking forward to now. Quantity of life SUCKS if it ain't got some quality to it. Just my opinion.
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Postby poetriri » Fri Jan 06, 2006 9:35 am

Harry,
Once again the door is open and I feel invited into what we Hoosiers call a 'pissing match'. I will not participate with you in such a contest. I will however point out a misunderstanding you must have had.

Now that's interesting.... he states that the unknown risks of PML will cause a hard sell to physicians. But later in the press release he says that since the risk of getting PML are only .01%, ( supposed data from Biogen/Elan based on their 3000 patients) it's well worth it since the deaths from aspirin are .02% ( data from millions of users)


The author was stating that merrill lynch and citibank believe it will be a hard sell...not his own opinion. You chose to view this as him contradicting himself. Actually, he was illustrating both sides. Something that you seem to choose to overlook when anyone is posting information on Tysabri.
I feel the need to state here that I am sorry that you have been turned into such a naysayer by your experiences over the years with drug companies and such. But, at the end of the day, we are gonna need hope and faith in said fat cat pharma companies in order to be rid of the ole MS.[/quote]
I say,
It's the fire in my eyes,
And the flash of my teeth,
The swing in my waist,
And the joy in my feet.
I'm a woman
Phenomenally.
Phenomenal woman,
That's me.
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Postby HarryZ » Fri Jan 06, 2006 11:20 am

Poetriri,

Once again the door is open and I feel invited into what we Hoosiers call a 'pissing match'. I will not participate with you in such a contest. I will however point out a misunderstanding you must have had.


The intent of my message is not at all to create, as you said, "a pissing match". I just happen to offer the "other side of the coin" point of view on the Tysabri issue. Some readers say that I'm a naysayer while others welcome looking at another perspective. Even MS researchers have huge disagreements on what is good and what isn't when it comes to treating the disease.

Perhaps I should have been more clear in my assessment on what Kam stated. I was referring to the article over-all on how there were some contradictions, not personally to his point of view. I guess I didn't spell this out enough and am sorry if it appeared I was implementing him.

As for my experiences with the drug companies....yes, I will agree...I have followed their work on MS for decades and have found little accomplished for MS patients and a lot of revenue generated to their bank accounts. And I fully realize that they are the only ones with anywhere near the resources to some day come up with an answer.

But that won't stop me from making comments on how they do business and how their only interest is making their investors happy and not too much to do with the health of MS patients. There are many people who agree with me and others that feel the way that you do. I respect your opinion but don't happen to agree with it. And everyone is entitled to his/her opinion.

Harry
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Advisory Committee CDER March 7, 2006 8:00 a.m. - 5:00 p.m

Postby better2gether » Sat Jan 21, 2006 6:07 am

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Advisory Committee CDER March 7, 2006 8:00 a.m. - 5:00 p.m

Peripheral and Central Nervous System Drugs Advisory Committee
Center Date Time Location
CDER March 7, 2006 8:00 a.m. - 5:00 p.m. Holiday Inn Gaithersburg
The Ballrooms
Two Montgomery Village Ave.
Gaithersburg, MD

Agenda:

The committee will discuss TYSABRI (natalizumab) biologic license application 125104/15; Biogen Idec Inc., for an indication in patients with relapsing forms of multiple sclerosis to reduce the frequency of clinical exacerbations. The committee will discuss the risks (including progressive multifocal leukoencephalopathy) associated with TYSABRI (natalizumab) administration, its efficacy in the treatment of multiple sclerosis relapses and/or disability, its possible return to the marketplace, and its proposed risk management plan(s).

Background material and meeting information will become available no later than one business day before the meeting (Simply scroll down to the appropriate committee heading).

Procedure:
Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person by February 28, 2006. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before February 28, 2006, and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation. Persons attending FDA's advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets.

FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Sohail Mosaddegh at least 7 days in advance of the meeting.

Contact Person:
Sohail Mosaddegh, Center for Drug Evaluation and Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane (for express delivery, 5630 Fishers Lane, Rm. 1093), Rockville, MD 20857, 301-827-7001, FAX: 301-827-6776, e-mail: mosaddeghs@cder.fda.gov

Advisory Committee Telephone Information Line:
Please call the Information Line for up-to-date information on this meeting, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512543.

http://www.fda.gov/oc/advisory/accalend ... 30706.html
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Postby amelia » Mon Jan 23, 2006 9:16 am

:( So this means we won't be hearing any decision until after March 7th? Excuse me while a vent a minute. I am sick of them dragging butt around on this. Other medicines and other data has come out even WORSE, but noooooooo, let's keep those erection correction drugs on the market. GOD FORBID THEY BE PULLED AND STUDIED! Sorry, but that's been in me a while!
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Postby HarryZ » Mon Jan 23, 2006 6:17 pm

amelia wrote::( So this means we won't be hearing any decision until after March 7th? Excuse me while a vent a minute. I am sick of them dragging butt around on this. Other medicines and other data has come out even WORSE, but noooooooo, let's keep those erection correction drugs on the market. GOD FORBID THEY BE PULLED AND STUDIED! Sorry, but that's been in me a while!


I understand your frustration on this, Amelia but you can only look to Biogen/Elan for creating the mess in the first place. Had they only followed their original plan of action for Tysabri they likely would not have had to pull the drug last February and leave thousands hanging in the breeze. Now they are forced to take the slow path back and it could have been longer had they not got a priority review.

Harry
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Postby amelia » Tue Jan 24, 2006 8:31 am

Is it just me or is this taking longer than it really should? I know the safety issues and such, BUT lets look at other treatments. There is the chemo treatment that has a lifetime dose limit. Possibly same one that turns you whites of the eyes blue, your urine blue, etc. Don't get me wrong, and if it is doing somebody good, then great! But everyone I have talked to around here simply turned BLUE! I guess other diseases on a time line gets frustrated too. But they keep dangling this darn carrot in front of us. Might approve it, gona do it fast, but wait, not now, maybe later, ............
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FDA Will Weigh Return to Market Of Drug for MS

Postby better2gether » Tue Jan 24, 2006 8:44 am

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FDA Will Weigh Return to Market Of Drug for MS

By JENNIFER CORBETT DOOREN
DOW JONES NEWSWIRES
January 24, 2006; Page D6

WASHINGTON -- The Food and Drug Administration will convene a panel of outside medical experts on March 7 to help determine whether Tysabri, a treatment for multiple sclerosis, should be allowed to return to the market.

The agency said the panel will discuss Tysabri's "possible return to the marketplace and its proposed risk management plans." Tysabri, made by Biogen Idec Inc. and Elan Corp., was voluntarily removed from the U.S. market last February after two patients developed a rare brain disorder, and one died. A third patient was later discovered to have the disorder, known as progressive multifocal leukoencephalopathy, or PML, in studies of the drug for Crohn's disease, an intestinal illness.

The FDA typically follows its panels' advice but isn't required to. The FDA is expected to make a final decision on Tysabri's fate by the end of March.

Biogen, Cambridge, Mass., and Elan, based in Ireland, said yesterday a review of about 3,000 patients who had taken Tysabri showed no new cases of PML.

If Tysabri is allowed to return to the market it will likely contain new warnings about the possibility of PML and restrictions. The FDA first approved the drug in November 2004 to treat MS, a progressive disease that affects the spinal cord and brain and involves damage to nerves that control muscles and vision.

Biogen and Elan filed for permission to return the drug to the market in September. The FDA granted so-called priority review status to the application, which is usually reserved for drugs the agency deems would be a "significant improvement" compared with existing treatments if the product were to be approved. It cuts about four months off of the typical 10-month review period for a drug.

When Tysabri was approved, many analysts believed it would become the top MS treatment after indications the drug was more effective than current MS treatments like Avonex, also made by Biogen.

Write to Jennifer Corbett Dooren at jennifer.corbett-dooren@dowjones.com

http://online.wsj.com/article_email/SB1 ... jMxWj.html
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Postby amelia » Tue Jan 24, 2006 10:22 am

:? I guess I will just have to busy myself with other things so time will pass a little quicker. I've written twice to FDA my opinion. And that is probably all it is. I think this is more of a dog and pony show than anything else.
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Waiting, always waiting...

Postby Ronnie » Fri Jan 27, 2006 9:04 am

Hi! I must admit, I have been too depressed, sad, downtrodden, grieved, and hopeless to even access this site for about, oh, a month now. I don't even remember when I signed on last, probably after my birthday, but not much later than that...

However, I have had Betaseron, Copaxone, Novantrone, Rebif, Tysabri, and now Copaxone again. I have been diagnosed definitely since 1994, probably since 1990, and I have been told over and over that a definite cure would happen in my lifetime, probably in five to ten years...

Strange how it is always five to ten years, how I am always waiting to start living again, and how time still seems to be passing in the regular world.

The Tysabri really worked well for me. I only received two doses, though, so maybe it was just wishful thinking. At least I didn't have to give myself shots every day, and I wasn't turning my injection sites into lunar landscapes. I have interesting divots and potholes on my legs now, and I assume the backs of my arms and rear look just as variegated.

People used to tell me how they admired my optimistic attitude. Perhaps I can be optimistic again someday.

This "new news" about Tysabri at least makes me feel happier. Good things may happen soon.

"We'll meet again, don't know where, don't know when, but I know we'll meet again some sunny day..."

Take care,
Ronnie :?
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Postby bromley » Fri Jan 27, 2006 9:14 am

Ronnie,

I know what you mean about the cure in five to ten years time bit. The worse one is 'there's never be a better side to get MS'.

But could you tell us how Tysabri helped you.

Thanks

Ian
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Postby amelia » Fri Jan 27, 2006 11:05 am

Yes, do tell us how it helped you. Wow in 1984 when they started kicking around the idea that Gary had MS, there would be cure in 5 - 10 years. Sad to say that if they did find a cure, it would take 5-10 years before the FDA would even look at it.
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How Tysabri helped me (I sound like a testimonial)

Postby Ronnie » Fri Jan 27, 2006 1:37 pm

Dear Amelia and Bromley:
Well, it was subtle, but...

I had been on Rebif for about five or six months, following the time I finished my lifetime dose of Novantrone. The chemo had been very positive for me, but I hated being sick for about ten days every three months. Anyone who has done the Novantrone (yeah, blue pee and incredible queasiness, diarrhea, etc) knows what I mean. Just describing it I can see how it looks negligible, but going through it was torturous.

The Rebif, with three shots a week, was less of a problem than the Copaxone, which when I last had taken it had started to give me the chest pain and inability to breathe problem, almost once a week. Then I started to get really painful injection site reactions. When we visited my in-laws in Wichita that Winter, I had a bruise appear on my left upper arm that reached from the elbow to the shoulder, with a painful swollen mass in the center where the injection was. My primary care doc said I must have hit something with the needle.

When the Tysabri came out, my neurologist had been one of the doctors in the study. She got me started at the end of January, and I had my second shot on the last Friday of February. I read Yahoo! news the next Monday, and I was the first patient to call the infusion nurse's office to pass on the bad news, halting all infusions that morning around 8 am.

I had refused to go on more than one drug at a time, and I started Copaxone sometime late March or early April.

During the time I was on Tysabri and immediately following, before I started the Copaxone, I realized that I was walking better than I had, and that the double vision which I had suffered for years had cleared up. It was never a problem in the center of my visual field, only when I tried to glance to the sides, and I had become used to turning my head, so I didn't realize right away. It hasn't really come back yet, either, although my vision is getting fuzzier and fuzzier lately.

Like I say, it was only two infusions, and the differences were very subtle. Now I am having much more trouble with fatigue, gait, and of course, fuzzy eyesight.

I am not sure if the fuzzy eyesight is from the MS or just getting older, which we still have to endure. I always think it is unfair that we may have to have more than one health issue, since it seems we are already taking on more than OUR fair share!

I am going to sign off right now, so I can run errands and pick up my daughter. Thanks for responding!
Ronnie :)
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Postby amelia » Fri Jan 27, 2006 3:03 pm

Great to hear about the eye sight. Gary is blind in one eye and can't see out of the other. Although his RE sight is trying to come back some. Not much. He hasn't driven in years, obviously. But we never have been able to sell his truck. People fuss at us about keeping it, but it is the last shrine to his driving. Hoping one day he'll drive again. Probably 5 to 10 years! Gary is anxiously awaiting Tysabri, as I have stated many times. Risk and all. 8)
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