Doxycycline and MS

I know this is old news but something I have thought about for over three years now...

http://www.medicalnewstoday.com/articles/91379.php

While this was hardly a major clinical trial as compared to the trials with FTY720, I have had my own personal experience with Doxycycline and MS that, at the time, I was told by my neurologist was just a fluke. This had been prior to the article which was written in December 07.

Being allergic to everything from Penicillin to Levaquin, there are very few antibiotics that I can take. I had begun having symptoms of a urinary tract infection and, not being able to get it under control, I visited my primary care physician. He prescribed Doxycycline at 100mg twice a day for 10 days.

I was not on any MS therapy at the time and was in the midst of a relapse involving my legs being numb, burning and weak.

A few days into the treatment for the urinary tract infection I could have sworn I noticed a marked improvement in my MS symptoms. It felt to me the same way it does after steroids. Like something had tamped out the fire in my nervous system.

Next time I saw my neuro I mentioned this to him and he chuckled and told me it had to be coincidental that my MS appeared to improve while on Doxycycline. So that was that. I blew it off, never to think of it again until next time I had a UTI and needed it.

During the first six months of my participation in the TRANSFORMS trial of Fingolimod I had many UTIs as well as URIs. As often as once a month for that first six months. Each time I was placed on Doxycycline to treat the infections. Although I was not relapsing at the time, just the act of taking those blue capsules brought back the memory of how it had once seemingly quieted an MS attack all those years before.

Now don't go taking my word for this because I will tell you up front that I am not a medical professional and do not profess to be. I'm merely an MS patient who has her own thoughts on things and sometimes wonders them aloud here in my small corner of the internet. Should you chance upon these words, please take them as musings of an untrained observer.

That being said.... I wonder... ("here she goes", you say)

I wonder if what they concluded in the small study of 15 patients with active RRMS that stated "doxycycline, and other antibiotics in the tetracycline family, may help combat MS and other inflammatory diseases by slowing down enzymes that attack certain cells of the nervous system." might actually be true?

The sad thing is that we may never know. Doxycyline has been around since its development in the 1960's and was first marketed under the name Vibramycin by Phizer, Inc. It's a cheap drug. A 30 day supply costs roughly $22.

Compare that to the nearly $4000 that Gilenya is going for on www.DrugStore.com and you can see why there are no massive studies being done on the possibility of an old, relatively harmless antibiotic being used as a therapy for MS.

It's all about the almighty dollar, and investors, and breakthroughs that might lead to a well-padded bottom line, not necessarily to affordable treatment for all. Who cares about that? Let the government cover the cost for the uninsured poor folks who qualify and let the insurance companies pay for the rest. For those who fall between the cracks?

Well, unless we can traverse the land of patient assistance programs and beg for free meds, or meds at a reduced price, from the Almighty Drug Companies who bottle our future and hold out a greedy palm in exchange for Quality of Life, then we're basically screwed.

Too bad the world isn't a more compassion-driven place. Could you imagine a world where your possessions, accommodations, health and happiness were not solely based on the paper in your wallet? What if it were a compassion-based society. Where we did things for others because it was the right and moral thing to do. In return our needs were also met by other compassionate-driven people.

There would have been cures for cancer and MS and other horrible diseases long ago. Instead, we are a society driven by greed at the expense of others. There will never be a cure for cancer or MS or any other costly, debilitating disease or condition simply because the money is in the maintenance. Cure them and there's no more costly meds they have to have.

It's the same philosophy behind big tobacco. Hook your consumer and you have a customer for life. There's no way we are ever going to outlaw tobacco as the cancer causing carcinogen that it is. There's just too much money at stake. Too many greedy, unethical people driving the beast.

Big pharma has no reason to find cures. There's no money in a world rid of cancer or MS. And if you aren't happy about that they can help. They have a pill for that.

I'm not trying to take the wind out of the sails of the S.S. Gilenya by any means. This is a most wonderful pill that I am happy the world of MSers now has at their disposal. The only thing is, it's just a big tease for many of us. I am just appalled and ashamed of us as a human race that we have *evolved* to this. Charging outrageous fees for a medicine that has the potential to help so many. That's not evolution.

Don't argue that it was the biggest clinical trial in MS history and that there are so many costs to cover. Novartis will recoup those costs in the first year, I'm betting. Then after that, what is the excuse? That CEOs need bigger 3rd homes?

Or will the price drop? Ha!

 I remember being appalled at the cost of Copaxone back in 1999. $600 for a month's supply. Simply outrageous. I never imagined in my wildest dreams that the prices would skyrocket the way they have. When big pharma realized the gold mine they had in the *maintenance* meds, who was to put a foot down and stop them? The answer is NOBODY and that's why the pricing is out of control. They charge so much because THEY CAN.

There is no way the production of a powder in a gel cap costs as much as pre-filled refrigerate-at-all-times syringes costs.

Gilenya will be no harder to produce that Doxycycline, except that 100mg of the latter is a MUCH bigger capsule. I just hope I can continue to receive Gilenya which has been directly responsible for my good health these past three years and I don't have to resort to trying out my theory that Doxycycline might help me.

Do we really want to do something about the healthcare crisis in America? Start by getting the drug prices and costs of things like MRIs and CTs etc. under control. The crisis stems from greed. Meanwhile people suffer and die needlessly.

Taking a deep breath...

Ok, so the issue of cost of Gilenya has been weighing heavily on my mind for as long as I have been having such great results. I knew it wouldn't be as cheap as say my Estradiol (which I get for $17.99/mo) but was never expecting $48000/year as mentioned in my previous blog entry, either.

Thank goodness someone is thinking straight and had the presence of mind to call Novartis and try to get the info straight from the horse's mouth. The Queen put her foot down (see profile pic at link) and demanded to know the one true answer. Here's the queen's comment from the last post (in case you don't want to bother with all that clicking and scrolling):

I read a little more on this today [regarding the topic of my last post], and the person giving the info has no relationship with Novartis, he's just a stock market analyst commenting on stock. He says Novartis could charge as much as $40,000. Well, they could. Doesn't mean they will. I called the Gilena line and the woman there said two things: 1)she couldn't give me the exact price and 2) she suggested Novartis has a very generous assistance program if I couldn't afford it. I started to laugh and asked,"Do you know of anyone who could afford to pay over $100 PER PILL?" and she laughed. I was encouraged after I spoke with her.

I suppose that's why she's The Queen, taking that logical, level headed approach and all. Thanks for calming me down.

So, here's my plan. I got a link in a Google Alerts email I have set up, and found that Novartis has launched a brand spanking new website for their baby: http://www.gilenya.com/index.jsp .

I signed up to be updated on new information and to allow them to contact me. During the sign up process, one of the questions asked was about the current therapy I was on. One of the choices was Gilenya. They then asked how long I had been on it, giving me several choices to choose from -- 3-4years being among them.

This tells me that they are interested in contacting us lab rats and getting our input on our personal experience. I found that interesting. If they call I may just direct them here and tell them to start from the beginning. Make them work for the info. Muahahahahaha.

Also at their website is a pdf of the:

MEDICATION GUIDE
GILENYA™ (je-LEN-yah)
(fingolimod)
capsules

Here's the link: http://www.pharma.us.novartis.com/product/pi/pdf/gilenya_pmg.pdf

I just noticed, while reading what I have copied/pasted above, that once again I have already been mispronouncing a medication name.  "je-LEN-yah" sounds even stupider than the "gill-EEN-yah" I had been saying. Oh well, maybe that's Swiss for "cure". Hopefully not for "suck you dry of all you money and worldly possessions."

There is a phone number, address and email listed to contact them regarding je-LEEN-yah and without further ado, here they are:


1-888-NOW-NOVA (1-888-669-6682)
Monday - Friday, 8:30am - 5:00pm EST

Customer Interaction Center
Novartis Pharmaceuticals Corporation
One Health Plaza
East Hanover, NJ 07936-1080

Email (actually a contact form):
https://www.gilenya.com/jsp/utils/contact/info/emaili.jsp

I plan on calling them Monday to pick their brains and see who I need to kneel before and beg for free medication for all of the test subjects (and here's the kicker) REGARDLESS of income or insurance coverage.

I have heard stories among the various trial participants of some of us getting reimbursed travel money for getting to testing sites. Not only have I NOT gotten reimbursed, I have been billed many times over for tests performed as part of this study, with the ophthalmology department being the most consistently guilty of this practice.

I know I read the informed consent and agreed to their terms that I would not reap any benefits beyond the possible health benefits due to the medication, but I'm talking about the morality and compassion of the issue here.

I think congress needs to be lobbied on behalf of clinical trial patients everywhere to make it a law that if a medication gains FDA approval those who risked their lives in the name of medical advances should be granted free access for life to that medication regardless of their financial status or insurance coverage.

If this were law, you might even find that the attraction of joining a trial would increase and there would be even more test subjects available to expedite the advancement of future medications.

I don't know how to go about lobbying for this, and maybe there aren't that many folks who agree with me or would be as passionate on the subject, but there MUST be someone out there who either knows, or knows someone who knows, how to go about turning this into one of those made for TV movies based on a real life drama and get the action needed to see this as more than a pipe dream (or pipeLINE dream, get it?) and have it be reality.

I truly believe everyone has a purpose in life. Our mission is to discover it and see it through. Maybe I have finally found my calling. Anyone with me on this?

Here is a formal call out to anyone out there who knows how to get started on this. Please leave a comment with your thoughts and any info that could point me in the right direction. In the meantime I'll go google how to get a law passed. I knew I should have paid more attention in Political Science class.

HIGHLIGHTS OF PRESCRIBING INFORMATION FOR GILENYA

http://www.pharma.us.novartis.com/product/pi/pdf/gilenya.pdf

Here's the highlights from the prescribing info sheet for which we all got poke prodded and inspected to provide the data.

Gilenya to cost $48000 per year!!

Holy CRAP!

http://www.bloomberg.com/news/2010-09-30/novartis-gilenya-ms-pill-to-cost-48-000-a-year-update1-.html

What I want to know, oh You Who Run Novartis Yet Do Not Yourself Suffer From MS, is how you people can sleep at night.

Give us a pill which will change our life -- mind you NOT CURE MS so we can be done with it, but merely give us hope and ease our suffering in such a way as to make us Fingolimod junkies for life -- and then try to make us pay $4000 a MONTH for it?? I KNEW when I saw those souped up pill container prototypes in that survey I was asked to take that you would be pulling this. Didn't I say just that?

This really ticks me off. It's the height of greed. I realize the trials were huge and cost tons of money, but production is going to be cheap. There are no syringes to supply, no medication to keep refrigerated. You know as well as I do that you will recover your testing costs within probably the first year on the market. This is just OBSCENE! I can't even begin to put into words how disappointed I am.

Do you think people with MS are just all rich or something? How dare you take advantage of our condition that way. To bring a pill to market -- sure, so you can profit, I get the goal -- but to make it so astronomically priced as to only be a cruel tease for those of us who can't afford it.

It was mentioned in the article that there are assistance programs for those who can't afford it. Well here's a novel idea you can do a clinical trial about... see how much further your drug goes to help people when you price it affordably to start with.

It's human nature I guess

Ever wonder why the nightly news is always negative? Why we will zip right by an amazing sunset, but give us a good car wreck and we are slowing down to take in ever gory details? I guess it's only human nature to be fascinated with the ugly side of life.

I went to a message board for people with MS. Anyone who's had MS for any length of time has been there, I'm sure, as it's probably the biggest one for our condition on the web. I used to hang out there quite a bit back before the trial started, and even well into my first year of the study.

Then one day I realized there is life outside of MS and I was feeling so much better on the Fingolimod (ok, ok Gilenya) that I wasn't dwelling on my condition as much as getting back to the business of living. Once I broke away from that message board my head became more clear and my depression started to lift. I attributed it to the medication and the relief of finally having the relapses subside.

Well, yesterday I went back to visit and see if anyone was talking about the pill. I mean, I'm so giddy with excitement that I just had to see what folks were saying. I found a thread where the mention was made of the drug getting approval, and while most folks seemed hopeful, several others were quick to point out the serious side effects.

I was overcome with an urge to let everyone know just how much good it has done for me, so I posted.

Imagine my surprise and hurt when someone responded that they were tired of hearing good news and wished someone who'd had side effects would post.

Really?? Good news about the long anticipated PILL FOR MS was something they didn't want to hear?? I know I'm Novartis' #1 fan and I feel I owe them my very health as I know it today, but they ain't payin' me, people. This is real and it's my genuine experience. I haven't been blogging for the past 3 years just to string you along and lure you in so Novartis can finish you off with their pill. True, your mileage may vary, but come on! I"m not the only one out of the 1250 or so trial participants (in what has been touted as the largest clinical trial for MS EVER) to have a positive outcome.

What? My experience ALONE got the FDA to say "ya know, that patient #008 at that Florida location seems to have done really well. Ah, what the hey, let's give it a rubber stamp and call it a day."

I'm not buying it.

Especially after the Tysabri fiasco, don't you think they are crossing t's and dotting i's these days when it comes to immunomodulating drugs??

So I left a comment saying I was sorry to have been the bearer of good news and that I didn't realize they weren't looking for that.

I won't be going back. I know that a lot of great folks are there and that there is a lot of suffering going on and people looking for camaraderie, but there is also a lot of negativity. I don't need that in my life.

There are too many beautiful sunrises I want to pull over to watch. I'm not stopping to see the train wreck, and if you wanted me to tell you about it I guess you'll just have to wait for the evening news instead.

Today is the day!! The FDA Approves Gilenya (Fingolimod, FTY720)

I had been watching closely all day yesterday for the mention of approval, but went to bed broken hearted.

Today was a mad house of domestic flurries and I forgot all about checking the FDA site. I even forgot to check my email all day until just now.

How fitting it was, then, that the first email I should happen upon was that of my clinical trial coordinator. She sent no message but rather a link to an article announcing the FDA approval.

I'm elated, excited, overjoyed and nearly in tears about this news. Whether tears of joy for all who have been awaiting the pill, or tears of sorrow as a chapter in my life will soon be ending and I will once again have to figure out how to pay for my meds, I'm not sure.

I feel like jumping up and down and I don't know why there's no fireworks when I look outside... surely it will be on the evening news, right?? I mean this IS BIG! The first EVER pill for MS. Wow! And I've been on it for 3 years already!


Anyhow, here is the news straight from Novartis' mouth:
http://www.novartis.com/newsroom/media-releases/en/2010/1445917.shtml

And another link on Bloomberg Business Week:
http://www.businessweek.com/news/2010-09-22/novartis-awarded-u-s-approval-for-ms-pill-gilenya.html

I guess I have to get used to saying "Gilenya" now. Took me forever to learn to spell Fingolimod. Thanks Novartis.

Really, though... THANKS NOVARTIS!! -- and CONGRATULATIONS! You gave me my life back one pill at a time. I wish you much success with lots more MSers out there.

We Were Beaten to the Punch! Russia Approves Fingolimod!

Russian Authorities Become First to Sanction Novartis’ Oral MS Therapy

 GEN news highlights: Sep 10, 2010

Russian regulatory authorities have approved Novartis’ Gilenya® 0.5 mg once-daily oral treatment (FTY720; fingolimod) for relapsing remitting multiple sclerosis (MS). Russia is the first country to approve the sphingosine 1-phosphate receptor (S1PR) modulator, and Novartis plans to launch the drug in early 2011.


An FDA decision on Gilenya is expected during September, and the outlook for U.S. approval looks promising, given that the agency’s advisory committee gave the drug a unanimous thumbs up back in June. Gilenya is also under review by the European Medicines Agency and by other regulatory bodies worldwide.
 
Novartis says Gilenya is the first oral therapy for treating relapsing MS. The Phase III trial program confirmed the drug reduces relapses, disability progression over two years, and brain lesions. Data also showed Gilenya to be more effective than Biogen Idec’s Avonex®, the firm adds. The FDA granted Gilenya priority review status in February 2010, reducing the standard ten-month review to six months. In May, the FDA extended the priority review period by three months to September 2010.

================ ~*~ ================

Aside from the fact that I believe they spelled Gilenia incorrectly, this news gives me chills. This wasn't a dead end, waste of time study (not that I thought so, but I remember my hesitancy when presented with the Clinical Trial option for trying out therapy). It's really coming to pass.

They beat us by 11 days. But it's coming. I expect ticker tape parades, special treatment, and paparazzi everywhere due to the fame we are all going to have once this thing takes the MS world by storm.

Reality check: ticker tape parade is when the paper shredder goes haywire, special treatment comes when you get phone calls from bill collectors asking for you BY NAME! and the paparazzi is just someone in your family catching you having a bad hair day and deciding for some reason that it should be recorded for posterity.

I can be famous if I try hard enough... see?

GOOOOOOOOOOOOOOOOOOOOOOOO Fingo!