My Tysabri Diary..., ever have one of those days????,

Hi everyone - I had my 36th Tysabri infusion on Wednesday, 7/8. All went well, no problems. I did find out that the young lady that just started Tysabri recently at my infusion center is doing really, really well according to my infusion nurse. Apparently, this particular patient is responding favorably and in a very drastic way to her Tysabri infusions. In particular, prior to her first infusion she was on the verge of progressing to the use of a wheelchair, but now after her third infusion, she no longer even uses a cane!

After sending various e-mails to Élan requesting information which had been omitted from the "Tysabri for Crohn's" page on Élan's website under the PML patients' past treatment histories (specifically, post marketing patients #1 and #6), I was finally contacted just this Tuesday by the person responsible at Élan for posting the information.

I had a lengthy telephone conversation with the Sr. Manager of Medical Communications with the Élan Medical Information group.

Now for the frustrating part & an explanation for my mixed feelings ..., She stated that because I am not a medical professional, she could not disclose that information to me, nor did they even have further information about patients #1 & #6. She then proceeded to tell me all about the FDA restrictions regarding disclosure and that I should speak with my neurologist if I want further information.

We went round and round and round and she had in her head that there was nothing wrong with the information posted there, and I emphatically insisted that there was notably incomplete information regarding past treatments for patients #1 & #6..., were they previously on monthly pulse steroids, IVIG, any kind of immunosuppressive therapies for other conditions, etc.? She finally acquiesced and said she would take a look at it, but if the patients' doctors do not advise Biogen/Élan of such therapies/conditions, their hands are basically tied because they cannot force the doctors to provide such information. I asked her if she would even discuss this with Biogen and send a follow-up questionnaire to these two doctors, and she never said anything. (first she states in her e-mail that she has additional information, and then she says she doesn't).

The information I am referring to is located on the www.elan.com website, and to access this information you must be a medical professional, and because the information is copyrighted, I cannot post the information here.

I told her that a doctor friend of mine sent me the information from their Tysabri/Crohn's website, and she said that was fine, but was significantly rattled when I was making the connections between these PML patients and prior immuno modulating therapies & immunosuppressive therapies as it related to the link to PML - and not the link to Tysabri.

So all in all, I'm not sure she will do anything if it becomes too much work for her. I am thoroughly exasperated and disgusted at this blasé attitude, especially from Élan. They really don't seem interested in promoting Tysabri (even though this is Biogen's contractual obligation here in the US) , nor do they seem interested in protecting Tysabri's good name..., oh well - I tried (sigh) Lauren .

In closing to my post here, we exchanged the following e-mails..., Here is her original e-mail to me:



Hi Lauren,

My name is Michelle XXX within the Elan Medical Information group, and I was forwarded your TYSABRI questions that you had initially sent to XXX here at élan. Thanks so much for bringing the inquiries about the TYSABRI PML cases to our attention. From my understanding, we do have data that we can share in response to the questions you posed [the bold is mine]. Typically however, our guidelines are to make sure that patients receive this type of medical information through their doctors, to allow for a better discussion with them, especially as they may tie into discussions about their own personal medical care.

So, what I would like to do is get in touch with your doctor as soon as possible and share some of the medical data that we do have in response to the questions you provided, so that he/she can discuss them with you.

For any other patients who have similar PML case questions, we would instruct patients to contact their doctors with questions. If their physicians do not have the answers, we are happy to provide them with the data that is available.

I would have loved to call you directly, but I don’t seem to have your phone number! If you would like to talk directly, please feel free to contact me directly. At minimum, if you would forward your physician’s contact information to you, I will let him know the questions you have brought up to us, and provide him information that he can then discuss with you.

Thank you,

Michelle

Hi Michelle,

Thank you for your e-mail. In answer to your questions below, please be advised that my doctor is not interested in becoming involved due to his busy schedule and for various other reasons even though I previously spoke to him about my two questions. Yet here again, the information that I seek is being withheld from me. I would have expected this from Biogen so that they can protect their Avonex franchise, but never from Élan.

In a message dated 7/6/2009 4:05:54 PM Pacific Daylight Time, Michelle.XXX@Élan.com writes:

I would have loved to call you directly, but I don’t seem to have your phone number! If you would like to talk directly, please feel free to contact me directly. At minimum, if you would forward your physician’s contact information to you, I will let him know the questions you have brought up to us, and provide him information that he can then discuss with you.

...,I am available today (right now as a matter of fact) for you to contact me.

For the life of me, I cannot understand what is so difficult about providing this information to me..., I am not asking for any names so there will not be a violation of those two patients' right to privacy..., you either have the information or you don't.

On the various MS forums that I visit daily, false information is being provided by God knows who to these patients that are having a difficult time deciding on Tysabri therapy. I cannot provide accurate information about Tysabri if I don't have any cooperation whatsoever from either Biogen or Élan.

Please call me to discuss the above which will not only help these MS patients which are confused about Tysabri, but whose doctors wish to keep them in the dark when you and I both know very well that they will probably benefit from Tysabri therapy and not have to needlessly suffer debilitating relapses, which could probably leave them disabled. Is Élan really that heartless & uncaring?

Sincerely,

Lauren Roberts

I then asked her to send me an e-mail confirming our phone conversation, and this is what I received:

Subj: Getting back to you regarding your request for TYSABRI PML information Date: 7/8/2009 10:43:57 AM Pacific Daylight Time From: To: LGLBGL2003@aol.com Sent from the Internet (Details)

Dear Lauren,

It was good talking to you on the phone yesterday. Thanks again for providing your comments and feedback to us about the PML case information you mentioned you were shown by a health care professional.

As mentioned in our phone conversation, we have a policy against directly sharing clinical data that goes beyond what is publically available or what is within the prescribing information for TYSABRI, with patients. If in the future, you would like to obtain TYSABRI clinical information beyond what can be shared with patients, this would need to be done through your prescriber, who we could provide information to if requested by the prescriber. I know you are not happy with that, however I believe we were able to come to an agreement as to why our policies exist.

With much respect,

Michelle XXX

As mentioned in our phone conversation, we have a policy against directly sharing clinical data that goes beyond what is publically available or what is within the prescribing information for TYSABRI, with patients. If in the future, you would like to obtain TYSABRI clinical information beyond what can be shared with patients, this would need to be done through your prescriber, who we could provide information to if requested by the prescriber. I know you are not happy with that, however I believe we were able to come to an agreement as to why our policies exist.

Dear Michelle,


Thank you for calling me Tuesday, 7/7.

As I mentioned to you, there is much false and misleading information posted on the different MS forums about Tysabri. Furthermore, not to sound conceited, but I happen to know more about PML and clinical Tysabri information than my own doctor because I have been studying Tysabri/Antegren since 2000, and it is absolutely ridiculous that any information I request should go through him first, taking up his valuable time.

And we reached no agreement whatsoever other than you saying you would take a look at your website (Tysabri for Crohn's) so that you could see why I have been emphatically insisting that there is notably incomplete information regarding past treatments for patients #1 & #6..., were they previously on monthly pulse steroids, IVIG, any kind of immunosuppressive and/or immunomodulating therapies for MS or other conditions, etc.??? I am not asking for names of these individuals nor is this invading their privacy due certain restrictions under HIPAA.

I completely understand if these patients' doctors choose not advise Biogen/Élan of such prior therapies/conditions and that you cannot force the doctors to provide such information. You can't even issue a Subpoena Duces Tecum to obtain this information unless discovery is needed for litigation purposes. I offered the suggestion that you discuss this with Biogen and send a follow-up questionnaire to these two doctors, but you really didn't seem all that interested.

When I was making the rational connection between these 10 post marketing PML patients and prior immunomodulating/immunosuppressive therapies as it related to the link of PML (not the link to Tysabri), you disagreed and stated there was a link of PML to Tysabri. I disagreed with you again, indicating that the expert authors of the New England Journal of Medicine published data that PML is caused by a diminished immune system [not by Tysabri].

NEJM - Conclusions re: PML

This is why disclosure of any prior treatments such as IVIG, Novantrone, methotrexate, Imuran/azathioprine, etc., even for other conditions such as rheumatoid arthritis, are so very important, and therefore a supplemental questionnaire should be sent to the doctors of patients #1 & #6.

Do any of the Novantrone, methotrexate, Imuran/azathioprine, CellCept, Remicade, Rituxan, etc. websites plaster PML information all over their webpages and product labels?!?!?? No, they don't!!! When is a label change for Tysabri going to take place so that it is in line with the other medications which have been linked to PML??? When is Élan going to step up to the plate and call Biogen into action?!?

And you think I am unhappy??? You're darn right I am unhappy!!! Obviously, Élan appears to be quite complacent and uncaring that MS patients around the world are allowed to suffer needless relapses and possible permanent disability instead of fighting for Tysabri to be used as soon as possible with all of its outstanding data released to date..., why? For what? It probably has to do with the almighty dollar, sad, really, really sad.

I am thoroughly exasperated and frustrated that Biogen (but especially that Élan) is apparently doing nothing not fighting to get the correct information out to "information hungry" patients. Telling patients to seek information from their doctors that are highly uneducated when it comes to Tysabri is like telling a thirsty horse to go and drink water from an empty trough. In my eyes, and in the eyes of many MS patients, this is apparently because no one really seems interested in promoting accurate facts about Tysabri to patients that are seeking this information (even though this is Biogen's contractual obligation here in the US), nor does anyone seem interested in protecting Tysabri's good name.

For example, one MS patient wrote to me indicating that their neurologist told them that Tysabri can cause brain cancer..., excuse me??? Hellooooo??? And you think that these uninformed MS patients should talk to their doctors who are also uninformed??? These patients unequivocally have the right to access accurate Tysabri information.

Regards from a very unhappy & sad MS patient because many of her fellow MS'ers remain uneducated about the wonderful breakthroughs of early Tysabri therapy and how they could benefit tremendously if; their damage from prior relapses is not permanent; and if only one person cared enough to fight the good fight rather than allowing them to be kept in the dark, confused, uninformed, and hurting needlessly by perpetuating inaccurate misinformation and untruths about Tysabri.

Lauren Roberts (MS patient for 34 plus years, and current Tysabri patient that just completed her 36th Tysabri infusion)

Hi everyone, happy 4th of July tomorrow!

I wanted to post some additional information that was sent to me regarding the recent PML cases that have been linked to Tysabri..., as to prior treatments involving immunomodulators and/or very strong immunosuppressants, please note the following with regard to the Tysabri/PML chart that will be updated at a later time (my friend is currently on vacation for the next 10 days so it will have to be updated later)..., but specifically, the patients listed in the chart:

#7. Prior use of Rebif, Avonex, and Copaxone.

#8. Prior use of interferon beta 1-a (Avonex), and mitoxantrone (Novantrone).

#9. Prior use of Avonex, Rebif, and Novantrone.

#10. Prior use of interferon-beta, glatiramer acetate, and IVIG.

I am still waiting to receive information regarding prior use of medications for patient #6. It is most strange that no "prior treatments" information is given (and I'm not sure I'll ever receive this information). Once again, please note the prior use of very strong immunosuppressants and treatments such as Novantrone & IVIG are designed to suppress the immune system, and the different ABCRs were previously used to modulate the immune system.

Again, 8 out of the 10 new cases of PML occurred outside the US.

The above information can be found on the Élan website under Tysabri for Crohn's disease. Here is the Tysabri/PML chart which still needs to be updated:

http://pietynorwit.com/Tytable.htm

Have a wonderful and safe holiday tomorrow everyone!

((((hugs))))
Love, Lauren :)