Sunday, August 28, 2011

Setting the record straight

I have Google set up to send me email alerts when anything Fingolimod/ Gilenya related comes across the internet. Normally I might briefly check it out, but usually dismiss the stuff as old news.

Lately, though, there are so many people starting this therapy who are in search of accurate information to help them overcome their fear or at least give them knowledge on which to base their decision. When I see misinformation I can't help myself, I have to correct it.

I got such an email today that had a link to a discussion on one of the many MS forums. Someone wanted to know if anyone out there was on Gilenya.

A person who sounded for all the world like he knew what he was  talking about posted this:

I just attended a very intereting lecture on this drug last week. I had been considering asking my doctor about switching me in 2012; however after what I learned, Im not going to.

Gilenya is now being recognized as having some PML related issues, same as Tysabri....and the JC virus, which is what people get tested for before being started on either drug, makes over 50% of the candidates ineligible. I actually have the virus myself, they did blood draws at the meeting I attended. I got the results in 5 days.

The biggest risk besides cardio issues, is eye problems, making anyone who has had ON also riskier to take the drug. Macular Degeneration is an increased risk if you take this. The first dose and now they recommend the first 3 doses, should be done in a hospital or doctors office setting due to the risk of tachacardia- increased heart rate. This can cause additional problems down the road. The actual statistics which are available for efficacy arent that impressive and there is virtually no long term data available since the drug was released only this year for FDA approval for MS.

All of this is public knowledge if you do your homework, In my opinion the ease of taking the pill vs the risk, just doesnt cut it for me....but let us know what you think!

Naturally I had to respond. I went to all the trouble to create an account at this place, and it took me a good half hour to compose my rebuttal along with supporting documentation, and once I posted it's as if I was never there. Nothing showed up.

Not one to be easily swayed into giving up the discussion when I have invested so much time into composing my reply, I have decided to post it here. Maybe more people will see it and benefit from it anyhow.

Using my trusty "back" button on my browser I was able to return to the page on which I had composed the response and I'm copying/pasting it here...

My Response

I received a link to this discussion in a Google Alert email I have set up for all things related to Fingolimod / Gilenya. Usually I read them and dismiss them. I'm pretty familiar with the topic having been a part of the TRANSFORMS clinical trial and having just past my 4th anniversary on Gilenya. I don't know everything about it, granted, but know more than the casual observer or average MS patient.

The post by XXXX  however was troubling to me. Enough so that I felt compelled to create an account here on XXXX for the sole purpose of being able to ask for the sources for the information being provided.

First, where was this lecture you mention and who was providing the information?

Points you make that I disagree with:

1. Increased risk of PML. 
Where is the supporting documentation regarding this PML risk you speak of? You mentioned having your blood tested at this meeting for the JC virus. I believe you are mistaking the risks associated with chicken pox/herpes/shingles family of viruses with the JC virus. I have never been tested for the JC virus and I would think that if you were correct, that test would have been performed.  At the very least, if it were a new development as you say, my neurologist who also happened to be the lead investigator at my clinical trial location, would have gotten me back in there to test for this.

 From the Novartis website's Safety Information Guide PDF. (

Patients without a history of chicken pox or without vaccination against varicella zoster virus (VZV) should be tested for antibodies to VZV.

I WAS tested (as were all clinical trial patients and now so too are current candidates for Rx) for the VZV antibodies.

2. Risk of increased heart rate and first 3 doses in hospital setting.
The risk is with a decrease, not increase, in heart rate and this only occurs with the first dose. Unless you have had an abnormal EKG or significant drop in HR that does not recover during the first 6 hours, there is no recommendation for 3 monitored doses that I am aware of.

From the published trial results:
There was a transient, dose-dependent reduction in the heart rate that developed within 1 hour after the initial administration of fingolimod, which is consistent with the findings in previous clinical trials.12,13,23 Mean maximal decreases were reached after 4 to 5 hours of 12 beats per minute in the group that received the 1.25-mg dose and 8 beats per minute in the group that received the 0.5-mg dose, with the changes starting to attenuate within 6 hours after the first administration of the drug. Most patients had asymptomatic reductions in the heart rate of less than 20 beats per minute. Mild-to-moderate symptomatic bradycardia after the first dose of fingolimod was reported in four patients who received the 1.25-mg dose (0.9%) and in three patients who received the 0.5-mg dose (0.7%). Symptoms resolved within 24 hours without treatment. There were no cases of syncope. Second-degree atrioventricular block was reported during the first day of treatment in four patients receiving fingolimod — three in the 1.25-mg group (0.7%) and one in the 0.5-mg group (0.2%). Two patients in the 1.25-mg group had mild symptoms (intermittent dyspnea and dizziness in one patient and chest pain and palpitations in the other patient), which resolved within 24 hours without treatment. No significant effect on heart rate or atrioventricular conduction was observed with continued administration of the drug. Increases in mean arterial pressure occurred in both fingolimod groups (3 mm Hg in the 1.25-mg group and 2 mm Hg in the 0.5-mg group) during the first 6 months and remained stable between 6 and 12 months.

.3. Macular Degeneration as a side effect.
It's Macular Edema (swelling of the Macula at the back of the eye) that is possible, not macular degeneration.

From the published results of the TRANSFORMS trial: 
Macular edema was confirmed on central review in six patients receiving fingolimod — four in the 1.25-mg group (1%) and two in the 0.5-mg group (0.5%). In three patients, the macular edema was asymptomatic and diagnosed by ophthalmologic examination. Five of the six cases were detected within 4 months after the start of therapy. The edema resolved within 3 months after discontinuation of fingolimod in four patients, was unchanged 1 month after discontinuation in one patient, and was reduced 8 months after discontinuation in one patient. Mean visual acuity and retinal thickness were similar across the study groups and remained stable over the 12-month study period.

4. The actual statistics for efficacy aren't that impressive.
I guess that's a matter of perception and opinion. I went from relapsing every 3 months for several straight years with Copaxone  not making any difference to joining this trial in August of 2007 and going 4 years with no relapse. My study was a head to head comparison with 2 different doses of Fingolimod (1.25mg or .5mg) with Avonex. There was no placebo. We were blinded to the real drug until the end of the study. We had to take a pill and do a shot once a week. Turned out I was on the .5mg Fingolimod from day 1. The results of that study concluded that, compared to Avonex, Fingolimod had quite an impressive increase in efficacy.

Again from the published study results:
This phase 3 study shows the superior efficacy of oral fingolimod over intramuscular interferon beta-1a. Fingolimod reduced the annualized relapse rate to a range of 0.16 to 0.20, as compared with 0.33 for interferon beta-1a, corresponding to a relative reduction of 38 to 52%

I didn't come here necessarily to correct errors I perceived as much as to find out if there is any truth to the statements being made If there have been changes in documented findings for this drug I have a great desire to know. If you can substantiate your statements with supporting links, I'd love to see them.

I just have a strong feeling that while you meant well some of your statements were incorrect.

Link to data that supports my statements (see charts/images included for side effects, etc.):


Now, I don't profess to be an expert and there is a slim chance that he/she was right and I am wrong because I'm using outdated material compared to the new data they could be referring to. But I DON'T THINK SO. I'm just sayin'.

It makes me mad as hell when people go off half cocked and start posting things they sorta recall from a meeting someplace and try to pass them off as the gospel truth. If you're going to make these claims at least provide some supporting documentation from a reliable source of authority. Don't just say "do your homework, the data is out there". 

There are people out there who have MS,  who are looking for some way to battle this insidious monster, and would like to not waste their time on reading stuff posted by idiots who have no business possessing an opinion.

Call me an idiot, but that's my opinion. :P

My next blog entry is going to deal with how to do research on the internet. It will be aimed at the average MSer who no doubt is experiencing some level of anxiety and wants to be reassured by the information they find online.


  1. That is OUTRAGEOUS! As i've posted recently, I just started taking Gilenya about a month ago. I knew about it for a long time before it was even approved by the FDA in sept 2010 because I have been hoping for an oral medication (vs injectable) for years and regularly read up on clinical trials. Anyway, because of the work I do (medical degree in medicine, but constant editing/working with physicians) and because I have MS, i keep up with the details probably more than the average person, too. Plus, again, I just started taking Gilenya, so I had all of the preliminary testing just within the last couple of months. Unless all of those things that guy mentioned came out just in the past month, he's wrong. You were right in each of your counter-points. I'm so glad you had the patience and perseverance to gather up the info and present it in such a coherent manner. I would have just fumed about it here by myself.

  2. Jeri,

    Your response to this person was right on target and I for one thank you for it. You were able to respond to the inflammatory remarks with a calmness and maturity I can only wish for.

    As you know, I'm a clinical trial participant who has contracted with Novartis to speak live to MS patient who are interested in learning about Gilenya. I can emphatically say, to date,

    a. there are no confirmed cases of PML in people taking Gilenya,
    b. testing for the JC virus is not part of the protocol and
    c. blood draws are not part of Novartis-sponsored patient meetings.

    I can't decide if this person is a liar, a moron or just confused. But I can guarantee, they are wrong, wrong, wrong. And I'd sure welcome the argument that proves they are right, right, right. But I'm not holding my breath.

    BTW, I'm linking this post to my blog now. Hope you don't mind.

  3. My girlfriend was in one of the trials, so I've learned a lot of this info too. You know your stuff, and that was a really well-informed response. Good work.

    I honestly have no interest in promoting one drug or company over the other, but this information is out there and publicly available for anyone who cares to look.

  4. Thanks, Josh. I'm really not here to promote one drug over another either. Just blogging my personal journey with my own drug of choice.

    MS is such a unique disease for each person's situation, and we each have our own battles to wage. How we come to the decision about which weapon we choose to wage our war against it is also unique and personal. I'd never tell anyone what medicine to choose. Neither would I make statements designed to incite fear in the reader based solely on misinformation.

    When I see someone doing just that I almost feel a duty to correct it.

    By the same token, prove me wrong about things I state and I will be thankful and feel enlightened. But unless you can back it up with trustworthy, don't waste my time. Know what I mean?

  5. This poster's misinformation sounds totally made up! It is so far off, it's a joke. PML from Gilenya? A meeting where blood was drawn? Unbelievable and no facts to support these statements. Sounds like this person may have an ulterior motive.

  6. OMG just posted doing well gilenya and she posted check it outI cannot belived her misinformation I cant even bring myself to reply

  7. Clokem, I just went and read where the offending "Senior Veteran" on healthboards is posting that people are dropping like flies and no neuro is prescribing (to paraphrase). She's a complete and utter idiot.

    Her very signature indicates her level of negativity which permeates her posts: "Every New Beginning Comes From Some Other Beginning's End" . WTH?


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