Living With MS

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

Sunday, December 10, 2006



My Tysabri Diary...

Thank you ALL for your Happy Birthday wishes, and I hope you all had a safe and happy Thanksgiving holiday.

Sorry I haven't updated my Blog recently, but I'm fine, just
IRRITATED AS HELL AND ROYALLY PISSED OFF WITH BIOGEN AND THE IDIOT A**HOLE THAT REVIEWED MY BLOG AND ERRONEOUSLY REPORTED TO BIOGEN (WHO DIDN'T EVEN BOTHER TO INVESTIGATE THIS FALSE INFORMATION PROVIDED TO THEM!) THAT I HAD AN "ADVERSE EVENT" WHILE ON AVONEX THAT I FAILED TO REPORT...

W.T.F.??????

From Emails I sent and received, here is the series of events that transpired due to Biogen's negligent actions (AND THE NEGLIGENT ACTIONS OF THE IDIOT THAT REPORTED THEM TO BIOGEN-GOD HELP YOU IF I EVER FIND OUT WHO YOU ARE!):

Subj: ok xxxxx, Biogen just crossed the line
Date: 11/21/06 10:05:04 PM Pacific Standard Time
From: LGLBGL2003
To:
xxx



and i am so friggin pi**ed off right now, i'm STILL seeing stars! sorry for my language, but my neuro called me tonight at 8:20 PM my time (she was still working and she had called me at 7:30 AM today!)...

when i asked her what was wrong, she told me the following [paraphrasing]:

the patient (me) had reported on her blog that while on avonex, she had fallen, had been hospitalized, and was now confined to a w/c, and had failed to report these adverse events.

W. T. HE** ????????

BIOGEN IS TWISTING WHAT I POST ON MY BLOG TO SUIT THEIR WANTS AND NEEDS AS I NEVER POSTED THAT IN THE SEQUENCE THEY STATED, AND I HAVEN'T BEEN ON AVONEX SINCE 2004!!! THIS IS THE 2ND TIME BIOGEN HAS CONTACTED MY NEUROLOGIST WITH FALSE INFORMATION!


THE UNMITIGATED GALL AND NERVE OF BIOGEN!!!......

I AM
MAD!

***
This is what was sent/reported to my neurologist by Biogen on a form entitled "DRAFT" under B. #5: "
A female patient on AVONEX (formulation, dosing regimen, and dates of dosing unknown) reported via an Internet *blog* that she was hospitalized due to a fall (onst Sep 2006). Treatment was not reported. The outcome of fall is unknown. Additionally, the patient experienced a horrible (MS) relapse resulting in being confined to a wheelchair. AVONEX therapy was discontinued."

My email was forwarded to Biogen, here is their response (note my comments to same are inserted there in colored Caps):

From: xxx@biogenidec.com
Sent: Wednesday, November 22, 2006 10:41 AM
To: xxx
Subject: Re: ok xxx, biogen just crossed the line

Hi xxx -

Legal and regulatory requirements are sometimes counterintuitive and, therefore frustrating to all, including us. We are not a corporate entity, we are a collection of human beings (THAT ARE EMPLOYED BY BIOGEN, IDEC, EITHER DIRECTLY OR INDIRECTLY THROUGH THEIR AVONEX AGENT, MSACTIVESOURCE!!!) who are trying to do the right thing!!

The reason for the situation below is that we, as the employees of the manufacturer, have an obligation to explore every adverse event of which we become aware.
(I HAVE NEVER HAD AN ADVERSE EVENT TO EITHER AVONEX OR TYSABRI!!!!! EVER!!!) This includes information posted on a website. (THIS IS NOT POSTED ON MY WEBSITE EITHER AS IT HAS NEVER HAPPENED!!! The follow-up process is for the employee to tell drug safety experts at Biogen Idec, who then contact the provider to determine if the event is indeed an adverse event attributable to the product. In this case, it would seem not, (NO SH*T! GEEE, YA THINK MAYBE BIOGEN SHOULD HAVE INVESTIGATED THIS FIRST FOR ACCURACY???) but it is only through this process of follow-up that we maintain our commitment to fully understanding all reported and non-reported patient experiences and better understanding the safety profiles of our products. (THIS IS BS, GIVE ME A FRIGGIN BREAK!!! SEE ABOVE!!!) We have an obligation, as does every other manufacturer of a pharmaceutical or biotech product, to report the summary of aggregated analysis of all such events to the FDA on an ongoing basis. This has nothing to do with TYSABRI. (BS AGAIN, THIS HAS TO DO WITH AVONEX SALES WHILE TYSABRI HAS BEEN APPROVED! I AM NOT STUPID, BIOGEN HAS AN OBLIGATION TO INVESTIGATE THE 'PURPORTED' INFORMATION FIRST!) You should note that we do not/will not determine whether a patient can or can't receive therapy. That is a decision made by the presciber and the patient. (HAVING THESE FALSE AND ERRONEOUS "BIOGEN" LETTERS IN A MS PATIENT'S MEDICAL RECORDS AND ANNOYING OUR TREATING PHYSICIANS AND APPROVING INS. CO'S IS JEOPARDIZING OUR "CURRENTLY" APPROVED THERAPY! AND BIOGEN KNOWS THIS) Our goal is to provide information about the product, facilitate a system to assure that physicians and patients are aware of warnings and recommendations, and assure that only patients with relapsing forms of MS receive TYSABRI. (THAT'S ODD, DIDN'T XXX JUST STATE: "This has nothing to do with TYSABRI." ??? AS STATED PREVIOUSLY, THEIR ARGUMENTS DON'T HOLD ANY WATER OR TRUTHS WHATSOEVER!!!) In terms of safety information, we collect this from all patients through TOUCH to better understand the safety profile of the product. FURTHERMORE, THIS BS WITH BIOGEN STARTED BEFORE I WAS EVEN ENROLLED IN THE TOUCH PROGRAM!!!)

Please rest assured that the intent is right, even though the process is sometimes frustrating.
(THE PROCESS IS COMPLETELY WRONG, ESPECIALLY WHEN IT BEGINS WITH ERRONEOUS FACTS GATHERED BY BIOGEN ITSELF, AND PERPETUATED EVEN AFTER THE CORRECT INFORMATION WAS PROVIDED BY MY NEURO THE FIRST TIME THIS BS WAS STARTED BY BIOGEN IN 2006!!! AND THIS MUST CHANGE, NO IFS, ANDS, OR BUTS ABOUT IT!)

Please feel free to pass this information along to Lauren...

Best wishes for a Happy Thanksgiving.

XXX
________


As reported back to Biogen by my neurologist FOR THE 2ND TIME THIS YEAR, "this is NOT AN ADVERSE REACTION TO AVONEX, THE PATIENT HAS NOT BEEN ON AVONEX SINCE 2004! Etiology: Progression of disease."

This is for ALL IDIOT A**HOLES employed by/or reporting to Biogen (or other companies) that are viewing my Blog THAT CONVENIENTLY OMITTED THE FOLLOWING INFORMATION LOCATED IN [RED]:
"A female patient on AVONEX [I STOPPED TAKING AVONEX IN MID-2004] (formulation, dosing regimen, and dates of dosing unknown) reported via an Internet *blog* that she was hospitalized due to a fall [FROM A RELAPSE] (onset Sep 2006). Treatment was not reported. The outcome of fall is unknown. Additionally, the patient experienced a horrible (MS) relapse [IN JUNE OF 2005] resulting in being confined to a wheelchair. AVONEX therapy was discontinued [IN MID-2004]." HOW MUCH MORE CLEAR AND CONCISE MUST I BE, BIOGEN??? WAKE UP AS THERE IS NO EXCUSE IF THIS EVER HAPPENS AGAIN.


For the record here, it is not my
intent to antagonize anyone at Biogen, BUT MY POINT IS: regarding Biogen's "STRANGE" actions, Biogen cannot just 'shoot from the hip' whenever they feel like it without reviewing 'gathered' information from an idiot FIRST for accuracy, without paying the consequences - they get what they give..they need to change their UNETHICAL practices.

Biogen is
NOT required to send false inquiries to treating neurologists of Tysabri patients that could 'potentially' disrupt the patient's treatment regimen, as well as sending this false inquiry to the FDA (which erroneously remains in the patient's medical history) . Biogen has an OBLIGATION TO fully review the 'infomation' being reported to them for ACCURACY BEFORE they "rush to judgement" and start interferring with the patient/doctor relationship, which results in an additional burden and stress already being carried by the patient (that burden AND stress being the disease of MS).

Now that the above is out of my system, I am estatic to report that I just received 2 emails from MS patients (now friends-smiling) : 1) she just had her first infusion, and WOW, her partial words: "
I had NO side effects but I did notice the lame leg started to ache a bit and then it went away... well, after finishing and going through the after wait I stood up! And the leg was strong! Went out to eat, had a ball (in my scooter of course can't be too careful.) Went home and could lift my entire leg onto the couch by myself! Just like the left leg which has been fine. Next day my husband helped me walk through my mom's garage and into her house (used the quad cane since balance isn't back that much yet) I am sure a lot was excitement and partly psychological but boy was I excited! Next day I was a bit tired (all that exercise) and the leg is still stable. Is it possible it could start working that fast? Anyway,, I am thrilled (:+)))))))))))))."...

And the 2nd email from someone (who just saw the first neuro that saw me back in 1976, whoa! - lol) that has been fighting to get her Tysabri: "
Hi Lauren! Well after one month of daily conversations with the TOUCH people, insurance, and Dr. xxxxxxx office, I am starting on Tysabri on Dec. 13!!!! YEAH!!!!! I look at your blog once a week, and I hope you are well, and that Tysabri s still helping you. You have helped me perservere on and finally the day is near! Thank You!! Happy Holidays! xxxxx".

My guess is they both got an early Christmas gift, eh? I am due for my 3rd Tysabri infusion soon. Until then, take good care of each other...,[smiling]

(((lots of Love & Hugs)))


A very proud member of www.MSpatientsforchoice.org

16 Comments:

  • At 8:14 PM, Blogger Charles-A. Rovira said…

    Hello Lauren,

    you sound rightly pissed and, unless you're serving them with a writ, what right do they have to interfere with your first amendment rights?

    Yo go girl!

     
  • At 7:54 AM, Blogger mdmhvonpa said…

    Processes would work so much better if it were not for all the humans involved.

     
  • At 12:17 PM, Blogger Lauren said…

    Hi Charles, I think Biogen is just trying to quash Tysabri sales for the time being, as Avonex, and all other interferon and Copaxone treatments will be cannibalized by Tysabri, and they will do whatever it takes (like what they just did to me TWICE IN ONE YEAR) to try and thwart Tysabri therapy...sad really, as they are going against their "core values" by putting profits (Avonex sales-inferior therapy) before patients (disability improvements, slowing/stopping the disease process, and preventing further relapses by 68% with Tysabri therapy). This might change in 2007, but for now, I see Biogen doing nothing to make having Tysabri easily accessible (and maintaing its accessibility) for patients who want and need it. "Roadblocks" are apparently their speciality...(sigh). Take care, Lauren :/

     
  • At 12:22 PM, Blogger Lauren said…

    Hey mdm, how are you? This time, I have to quantify your response with the additional words: "low life" humans (sigh)...Take good care now, Lauren

     
  • At 2:02 PM, Blogger Karyl said…

    Wow Laureen, why don't you tell us how you really feel? lol Isn't Tysabri out of Biogen? I thought they were the same corporation.

    You have great spunk and will persevere over this mishap, to say the least.

    I'm ready for the fight, now to get to my neuro's appt in January. I wil demand Ty or go to another neuro, easy.
    Love you kiddo
    Karyl

     
  • At 8:35 PM, Blogger Lauren said…

    Hi Karyl, I do not mince words at all when I have been wronged! Grrrrrrrrrrr.

    Biogen Idec is the manufacturer of Tysabri (Elan Pharmaceuticals discovered Tysabri and distributes it).

    Biogen & Elan are 50/50 owners of the BLA for Tysabri (Superior)re: MS, and Biogen owns the BLA for Avonex (inferior) 100%.

    It is for the above reason I believe Biogen is putting profits ($) before patients (GAG)
    by protecting Avonex and not really marketing Tysabri aggressively.

    Karyl, is your neuro TOUCH certified? If not, he can't write a script for Tysabri per the TOUCH protocol.

    If this is the case, I would bombard his office with phone calls before your upcoming appt. in order to ascertain when and if he will be TOUCH trained and certified.

    Please, don't wait, ok? Take care, Lauren

     
  • At 2:12 PM, Blogger Karyl said…

    Howdy girl
    The first question I asked was is she TOUCH certified, that was before I would even make an appointment. it's Jan 10, I'm excited and trying to read everything about Ty. Now to twiddle my hands til then.
    Karyl

     
  • At 3:20 PM, Blogger Lauren said…

    Excellent Karyl! If you reeeeeeally want to read up on Tysabri, go to the links: www.mspatientsforchoice.org/ and http://www.elan.com/ (their "News" link and/or "Tysabri" links, including all "Archive" reports on both websites ... twiddling hands? I think not girlfriend (laughing)...

    Take care now, Lauren :)

     
  • At 11:42 PM, Anonymous Anonymous said…

    This comment has been removed by a blog administrator.

     
  • At 9:13 PM, Blogger Linda D said…

    Hey, Lauren!

    You go girl! That just plain SUX!!! I imagine they are happy as clams in mud that I CAN'T take Tysabri anymore (TOUCH gave the "no" nod), but I also CAN'T take Avonex either...surprising they haven't trashed my blog as I clearly had adverse reactions to Avonex that NO ONE seems to care about (ie., big pharma corporations)...just makes me wonder...hmmm?

    Linda D. in Seattle

     
  • At 12:56 PM, Blogger Lauren said…

    Hiya Linda! You said: "I CAN'T take Tysabri anymore (TOUCH gave the "no" nod)"...are you referring to having neutralizing antibodies to Tysabri? If so, that is just NOT correct according to the Tysabri label (see page 14 under Hypersensitivity and under Immunology) wherein it states "testing for antibodies should be performed" which I assume your neuro did, and that "the antibodies may be TRANSIENT and may DISAPPEAR with CONTINUED DOSING", http://www.Tysabri.com (the Patient Med Guide), and then test again after 6 months. Is this what happened Linda after you were on Ty for 6 months? (send me an email Linda if you prefer)...Lauren (sigh)

     
  • At 8:38 PM, Anonymous Anonymous said…

    being both an MS patient and working for the corporation which hassled you... [no, i don't even tell them i read your stuff and i sure as hell don't do it at work. makes more paperwork for me and i am not stupid] i know how the paperwork goes. i'm surprised they didn't investigate more either because on the front lines we have to report anything we hear if you've ever taken either drug if you have any kind of medical problem at all after the first does. i mean, if you say you had a car accident in which someone else hit you and you took avonex three years before only one time... we have to report it. and then the specialists [who apparently contacted your neuro] are supposed to figure out if it's relevant.
    it doesn't get put in your info at biogen though. the FDA requires that we record all of that as part of the TOUCH program, just like every single time someone calls, even if they call 4 times in one day, each and every person is required by the FDA to ask what therapy they are on if any.
    and there was a meeting... from now on, in 2007, we will be working with the FDA to be able to promote tysabri's efficacy in a fair balance to the risks. we have to get every word we say about tysabri approved by the FDA before we can say it.
    and in 2006 it WAS considered cannibalization. but not from now on. trust me, we're all happy about that.

     
  • At 9:52 PM, Blogger Lauren said…

    Thank you for your comment, but I strongly disagree with your reasoning and strongly reiterate: "This is for ALL IDIOT A**HOLES employed by/or reporting to Biogen (or other companies) that are viewing my Blog THAT CONVENIENTLY OMITTED THE FOLLOWING INFORMATION LOCATED IN [CAPS]: "A female patient on AVONEX [I STOPPED TAKING AVONEX IN MID-2004] (formulation, dosing regimen, and dates of dosing unknown) reported via an Internet *blog* that she was hospitalized due to a fall [FROM A RELAPSE] (onset Sep 2006). Treatment was not reported. The outcome of fall is unknown. Additionally, the patient experienced a horrible (MS) relapse [IN JUNE OF 2005] resulting in being confined to a wheelchair. AVONEX therapy was discontinued [IN MID-2004]." HOW MUCH MORE CLEAR AND CONCISE MUST I BE, BIOGEN??? WAKE UP AS THERE IS NO EXCUSE IF THIS EVER HAPPENS AGAIN."

    As a 'higher up Biogen rep indicated "The follow-up process is for the employee to tell drug safety experts at Biogen Idec, who then contact the provider to determine if the event is indeed an adverse event attributable to the product. In this case, it would seem not...

    I am sticking to my guns and as you state this is "documented" in my Tysabri TOUCH file...the fact that these are erroneous and false reports, TWICE submitted by Biogen should be a friggin clue that this procedure is dead wrong, and I won't hesitate to pursue the matter further if this BS practice does not cease with regards to my case forthwith! The stress Biogen has caused me FROM THIS has been paramount...UGH!

    On a happier note, you said: "from now on, in 2007, we will be working with the FDA to be able to promote tysabri's efficacy in a fair balance to the risks. we have to get every word we say about tysabri approved by the FDA before we can say it.
    and in 2006 it WAS considered cannibalization. but not from now on. trust me, we're all happy about that." ... I'll bet you are, and so are us on Tysabri... Woooohoooo!

    Thank you for sharing your thoughts with me, even though I don't completely agree with all of them.

    Please, take good care...,
    Lauren

     
  • At 10:43 PM, Anonymous Anonymous said…

    if people like you don't speak out, bad policies don't change. and obviously, bad policies should change if they create hassles.

    but seriously, if you call us, and we look, on the company side of things all we see is that a report was made, not what it was about. the drug safety team probably has more info, but it's protected from the regular people you speak to.
    i haven't, and don't plan to look at your information unless you call and happen to get me on the phone. and i'll never discuss anything in your blog with anyone, even you if you call.

     
  • At 11:19 AM, Blogger Lauren said…

    Again anonymous, thank you for your comments. I can appreciate them from your point of view as a Biogen employee (and I believe a MS patient also)...however, you need to understand my point of view...,

    You stated "a report was made, not what it was about. the drug safety team probably has more info"...,

    And yet a higher up Biogen rep. advises "We have an obligation, as does every other manufacturer of a pharmaceutical or biotech product, to report the summary of aggregated analysis of all such events to the FDA on an ongoing basis. This has nothing to do with TYSABRI.

    This has everything to do with Tysabri. BIOGEN HAS AN OBLIGATION TO INVESTIGATE THE 'PURPORTED' INFORMATION FIRST, before they even contact my physician, or anyone's physican, which is creating an undue hardship on the provider/physican AND the patient.

    If I should leave my Blog up for say the next 10 years, and some idiot employee reads my Blog, twists the information here, sends it to your "drug safety team" and THEY don't bother to INVESTIGATE the information as being PREVIOUSLY reported and PHYSICAN CLARIFIED FIRST IN MY FILE, DOES BIOGEN HONESTLY BELIEVE PATIENTS AND PHYSICANS AREN'T GOING TO BE UP IN ARMS AT THIS HAPPENING OVER AND OVER AGAIN??? THIS BIOGEN PROCEDURE IS FLAWED AND NEEDS TO BE CHANGED/MODIFIED.

    Biogen is on notice of this needed policy modification, if they choose to ignore it, well, you can surmize the outcome.

    The stress that ensues from these events is by Biogen's own performance, and no one else's...they need modify their "reporting policies" and need to re-train their "drug safety team" to review ALL information gathered in the patient's file first to confirm that the PHYSICAN HAS PREVIOUSLY CLARIFIED the 'reported' event before involving the provider/physican again, which creates an undue hardship on the provider/physican AND the patient, not to mention their own employees for 2,3,4+x's their unnecessary and duplicative work efforts.

    Perhaps Biogen enjoys wasting money, creating undue frustration, stress, and an overall unwellness in treating patients/physicans & their staff, and Biogen's own employees due to this flawed policy.

    This attitude is in direct conflict with their own "core values".

    That is my position, and I hope that you can appreciate same.

    I truly do appreciate your comments on my Blog. I can tell you care about the welfare of the patient, even when your company doesn't and/or is too lazy to change their bad policies.

    Sincerely,
    Lauren

     
  • At 9:50 PM, Anonymous Anonymous said…

    please, the fewer reports made, the less paperwork for me. i won't argue that AT ALL.
    and you are right, this has everything to do with tysabri. it's part of the TOUCH program. we have to report everything to the FDA as part of the agreement for bringing it back to the market.

    as far as i know it the procedure is to start the investigation of circumstances by contacting the doctor. i don't think that's right because the doctor often doesn't even know the whole story. only the patient actually knows what happened. i could be wrong about how that actually happens because all of that takes place far from me. in another state even.

    and i am really upset by hearing about the hassle this has caused you. i feel guilty every time i get a phone call where someone tells me about medical problems and i have to tell them it has to be reported. we are always told, on the front lines, to offer a patient upset by that fact, the option to have us just provide initials, gender and age. that can keep them off your back.

    and soon i'll know more about whether i am 'officially' an MS patient. more testing, not enough holes in my head. making the diagnosis official has been my hardest challenge. between insurance coverage for testing [previous job] and not having a drug to take [can't take interferon due to other issues] this has been going on for me for 7 years. not that my neurologist has any doubts, it just needs to be proven on paper. you know how that goes.

    but yes, the people i work with all also care more about the patients than about the profit. sometimes we talk about how company policies hinder our patients from getting the best care. i wish we had a way to fix your frustration with us.

    and i want to say how much i respect you for speaking out and making a stand for the cause of tysabri. i'm lucky enough that my neurologist advocates it and was in the early clinical trials

    people call me every day who want it so badly but their doctors or insurance companies gave them scare stories and it's really hard to answer the question 'if i take this drug am i going to die?' without breaking into tears myself out of empathy for their fears

     

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