Thursday, January 21, 2010

Mixed Emotions

I know I haven't blogged in a while but life has been driving me crazy since my major source of income dried up.

Just a few minutes ago, I walked by the TV where my mother was watching Fox News and I heard the words "MS" and "new pill". This perked me right up so I grabbed the remote, punched up the volume and sat back to soak it all in.

They didn't mention any names but said that 2 new pills were competing for first ever FDA approved ORAL treatment for MS. A doctor showed an MRI and described in grade school terminology the basics of the disease and what the pills do to combat it.

They spoke of a "news release today" that I was unaware of and so I sat down here to google.

My heart lept into my throat as I did a Google News search to find out that Novartis has filed for FDA approval of Fingolimod / FTY720 yesterday, January 20, 2010 -- exactly 2 years and 5 months to the day since I swallowed my first pill.

This is great news, however I am terrified by it. The clock is ticking on my free ride and I know it's silly because it's not like the FDA is going to just rubber stamp this today when it hits the big guy's desk, but it's a huge reminder that this trial is not going to last forever and I'm not going to get this stuff for free forever either.

I have GOT to get that letter done (the one I drafted and then set aside to go over again a few times but haven't yet gotten to) so I can send it off to the CEO of Novartis and ask him to help a guinea pig who's down on her luck out with a lifetime supply of Fingo.

I just don't want it to sound too whiny but ever time I read it, it sounds all "woe is me" or is that "WHOA!"?

Anyhow, when I get it written, I was toying with the idea of posting it for all to see here on the blog, but don't know how that would effect the results....

Any ideas you readers (if anyone still reads this) have for getting Novartis' attention and persuading them to give me drugs, please post them as a comment -- I'm all ears!

This has been a wonderful journey for me. I don't want to revert back to relapsing every 3 months and being chronically under the dictatorship of so many horrible symptoms. I would rather die than go back there.

When Novartis yanks their Magic Carpet of Fingolimod out from under my feet, I just know I'm going to fall into that dark, black, bottomless, horrifying pit of MS again.

I'm scared. Someone tell me how to keep that carpet, if you know a way!

Here goes nothing. I'll be on the edge of my seat following right along as we wait and see what the FDA has to say.

Cross your fingers, would ya?


  1. Hey there
    I would suspect that the pharma will be very interested to continue the trial or morph it into a longer term study.

    I know Tysabri patients who were on the initial two year trials and are still being supplied and monitored now (about seven years) as part of longer term studies for that pharma company that they were asked to continue on.

    Realise there's lots of 'ifs' and 'buts' but(!) it does seem like something that is very much in the pharma's interest to do, don't you think??

    good luck with it all - hey and hope you mention the great help your blog has been to all of us out here in cyber land who get the chance to read about your first hand experience on the drug thanks to the company having you on the trial, hey!! :)

  2. You could try appealing to them to make you a 'poster child' for Fingo... You know - literally! Rreal people success stories are always good.
    Not that this is going to happen tomorrow, but what usually happens to the participants of a long-term trial? I can't imagine the drug company just dropping them, but i guess I shouldn't put it past them.
    Hang in there!!!

  3. I actually work for a pharma company and I will tell you how this works. They will absolutely have a longer stage safety study and you might be chosen for that. If not, every pharmaceutical company has a patient assistance program. No need to call the CEO, just have your physician call to get the forms. Once approved, you will receive one year's worth of drug and can reapply every year for the rest of your life.

    I am really looking forward to this drug's approval - can't take any of the CRABs. Good luck and God Bless

  4. Thanks for the comments everyone!

    Jan, the study I am in (TRANSFORMS) was a 1 year trial followed by a 1 year extension. I have already completed the extension phase (that was over in Aug. 09).

    I was even "unblinded" a month or so ago and found out that I have been on the real Mccoy for the entire length of the study.

    Chekoala, I'm hoping for being followed long term, but the trial coordinator says they haven't mentioned anything to them about that possibility.

    Suze, I would love to be the Fingo Poster Child. LOL

    And Pat, I know about the Patient Assistance programs -- that's how I got Copaxone for a couple of years. The hassle of applying and the stress of *hoping* I qualify are things I would like to avoid if possible. I'm greedy like that -- I just want to get it for free for life and never have to worry about drug costs again.

    That, in my mind, seems like a fair trade for risking my life to help them write the insert sheet for the final product. ;)

  5. I have my concerns about the study ending too but I agree with Jan. They WILL do a long term safety study. The FDA will require it. They will use people from the earlier trials because it makes their data look better. And they will have some kind of assistance program because it WILL be expensive. The assistance program will be their only hope to convince physicians to start prescribing it.

    Usually I reserve this phrase for my children and people that are worried about sick relatives, but for you.......

    Everything is going to be alright. :)

  6. I am looking forward to the release of fingolomid, too. I've been on betaseron for several years and participated in a clinical trial with it. After the trial was over, the sponsors, if you will, had a program where participants could get the beta at a reduced price. I am seeing in the other comments that drug companies often try to let trial participants have a way to remain on the trial drug and feel sure you'll be offered a way to do this. Good luck to you! And thanks for participating in the trial. You've helped all of us.

  7. Tickled -would love to see your letter, but I think I'm going to talk to my trail coordinator to see if I can be in a phase IV trial. (by invitation only). yes, there are phase IV trials. That is the official term for collecting data on long term studies. I go Wed for a visit and am going to prob a lot, esp. since FINGO is at the FDA and my clock is ticking.
    I am like you - very little money. Even assistance would probably not be affordable.
    Hey, I want to be a poster child. Pick me! Pick me!

  8. Just want to clarify, there is no obligation by the FDA to do a Phase IV study. It is up to the pharmaceutical company to do so if it wishes. Most companies will do a retrospective study based on medical affairs reporting only. However, with the importance of this drug, and Tysabri's history, it makes much sense for them to do a large scale Phase IV. HOWEVER, they may chose to do a Phase IV study to examine other indications such as RA or Crohn's Disease, etc.

    I work for a company that makes MS drugs (won't say which) and I'll tell you our patient assistance program is very easy to qualify for. Your doctor should have the brochures and you just provide your W2s and your doc does the rest. Approval in about a week.

    Anyone know anything about the other oral drug in trial - forget the name but it's Laquimide or something like that?

  9. 3 days ago was my visit number 22, Two days ago was my three year anniversary! I've been healthy ever since. Other meds didn't work for me. I'm keeping my fingers crossed it's approved my the FDA


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