Tuesday, November 20, 2012

What the Wall Street Journal Forgot To Mention About MS Drugs

Why does it surprise me and infuriate me every time I see sloppy reporting being done on the subject of Gilenya? Maybe this time it had that effect because it wasn't on some message board run by idiots who were doling out misinformation as if it were the word of God himself. No, this time I was caught off guard by The Wall Street Journal.

Jonathan Rockoff  wrote an article for The Wall Street Journal that was published today, November 20, 2012 entitled, "As MS Pills Debut, Doctors Prescribe a Dose of Caution". It appears that Mr. Rockoff didn't do much homework in researching his piece, or at the very least he chose not to include a lot of valuable information that would make his article more accurate and less skewed toward sensationalism. 

I'm certain the fear of a new medication probably sells more papers than dragging out all the pros and cons of all the available therapies, but for those of us actually suffering from multiple sclerosis and trying to do our own research, he's not doing any of us any favors.

For one thing, the article only interviews one MS patient who has only been diagnosed with MS for two years, has only ever been on one disease modifying drug (DMD), has always done well on the drug and has her MS currently under control.

Where is the counter balance of a person who is actually on one of the oral drugs, for example Gilenya, and has not suffered side effects and is doing well? Where is the person jumping from one injectible to another only to suffer horrible side effects or a lack of efficacy from them? 

No, he just dives right in and states, with no further explanation that this woman won't try one of the oral medications.

"Still, a talk with her doctor, Peter Calabresi, persuaded not to take a chance on a new drug."

Well, duh. The very next paragraph goes on to say:

"'I don't have any side effects, and it seems to be working very well for me. Why switch it?' said the 52-year-old from Rockville, Md."

Why would anyone who has been battling this disease FIX something if it AIN'T BROKE?? If you aren't having any disease activity, you have a stable MRI and you are having no side effects, then WHY would you take a chance on anything, new pill or otherwise?

The whole article, from title to the way the "facts" are presented seem to be skewed to try and frighten people who don't have all the real facts.

For instance, the only mention of side effects of the injectibles that Mr. Rockoff made is in this sentence:

"Yet the injections can cause welts, itching or scarring."

He neglected to mention side effects of Avonex, one of the many interferons, like possible flu-like symptoms several days out of the week, possible depression and/or suicide. Likewise, he failed to mention side effects besides injection-site reactions from Copaxone such as an immediate post-injection reaction (This reaction, which usually occurs only once, includes flushing or chest tightness with heart palpitations, anxiety, and difficulty breathing.)

I researched the interferons and wouldn't take them due to the risk of flu-like symptoms that would surely impact my Quality of Life (as would depression and suicide, no doubt).

I DID take Copaxone for the first eight years post diagnosis. I had injection site reactions daily, getting huge, itchy, painful welts sometimes as big as the circumference of a tea cup. It felt like I was injecting battery acid under my skin, very painful. And even though I reported it to Shared Solutions, Teva (at that time) refused to acknowledge that the hardened dent I had at all of the injection sites on my body had anything to do with the use of Copaxone.) Now I see that on their prescribing information sheet they make mention of both "injection site fibrosis" and "injection site atrophy".

It would have been the responsible thing for this Mr. Rockoff to do some real homework regarding all the available options and present them in a format that one might compare the risks/benefits profiles of each side by side. No, he took the easy, sensational way out and glossed over all of the injectibles, choosing to focus his grandiose diatribe on how scary these new oral medications are and giving a not so subtle message that we ought to beware.

Well, here's the counterpoint, Mr. Rockoff: I am an MS patient who has tried -- and FAILED -- on Copaxone. Not only did I have terrible side effects which made being compliant a day to day battle, but it did nothing at all to slow my relapses OR my progression.

I started the clinical trial TRANSFORMS in August 2007 and have not had a single relapse since shortly before entering that trial. It was a double blind, double dummy trial in which neither I nor the researchers knew if I was on the real Fingolimod (Gilenya) or the real Avonex. This study had no placebo but was a study to compare efficacy and safety of Fingolimod to an established, approved MS DMD, Avonex. I did a shot once a week and a pill every day. At the end of the extension phase I was unblinded and told that I had been on the real Fingolimod since the very first dose on August 20, 2007. That's over five years of having not even one single relapse after relapsing at a rate of 3-4 times per year on Copaxone. How's that for efficacy?

The only side effects I have had on Gilenya are a slight drop in heart rate on the initial dose which recovered before the end of the six hour observation period (the observation that is required for all first time patients taking the drug.) I also had a mild increase in upper respiratory infections but that tapered off to nothing after a few months and now I have not even suffered so much as a head cold for well over two years.

I think it's important, when I read slanted articles designed to make people fearful of these new oral medications, that I jump in here and try to balance out the facts.

MS is a terrible disease to have to live with and decisions regarding treatment have to be made on a very personal basis. Hopefully it can also be on an informed basis and not made out of fear instilled by irresponsible reporting.

We are all different and because of that we will all respond differently to the medications. What works for me might not work for the next person. The important thing is that there are new options available to us coming down the pipeline all the time. If whatever therapy you are on isn't working for you, try something different. Research the medications yourself, but not by reading the Wall Street Journal, or message boards fraught with misinformation. Go to the NIH or FDA or read the patient prescribing information sheets like the two I linked to above.

Discuss all of your options with your neurologist. If your doctor isn't willing to listen then find a different doctor. We all need to be proactive about our own MS. After all, we are the ones who have to live with this disease. Try to be as well informed about it as you can.

And don't bother buying a subscription to the Wall Street Journal if that's the kind of "fluff" they're getting by the editor. Just my opinion.

Monday, November 5, 2012

Weight Loss and My MS

Ever since I quit smoking in 2007 right before entering the TRANSFORMS clinical trial for Gilenya (Fingolimod), I have been (at least in my eyes) overweight. I gained probably 15 lbs. after quitting cigarettes. For the sake of full disclosure and honesty, I'll say I started out at 115 lb. and ended up at around 129-130 lb. Over the last few months of trying first one thing then another I had gotten down to 124 lb.

Now I know a lot of people who struggle with their weight will look at that and scoff, telling me I should be happy when I weighed 130 and that it's still "thin" compared to their own weight. While this may be true, one's own body image is a matter of perspective with one's own perception often distorted. I have always been thin all my life, so having any "muffin top" or extra padding in places not formerly occupied by fat is unnerving -- and uncomfortable -- to me.

I have noticed that just the addition of 15 lbs. has made a real difference in how my body responds to the residual MS symptoms I have always had since my very first, and most acute, MS attack way back in 1999. My left leg has always been weaker than my right, and my legs seem to tire faster when transporting the 3 seemingly permanent 5-pound-sacks-of-potatoes I've acquired since giving up the butts. Just getting myself up from a sitting position takes more effort.

Bending over to tie my shoes can leave me struggling and out of breath. I feel greater fatigue. And refusing to give up the "skinny" jeans, shoe-horning myself into pants meant for a younger, trimmer me, adds nothing to my comfort.

I can't afford new clothes and I'm tired of seeing myself staring back from what obviously must be a fun house mirror because NO WAY can that be my stomach, hips or thighs. So I'm doing something about it.

I am all about taking control of your health. I have spoken on that very topic many, many times. I think a person should be their own advocate, make changes for the better wherever they can, and enlist the help of others when they need to. So it's only natural that, while I'm preaching self-advocacy, I need to DO something about this body that's making me unhappy.

When I was a small child my mother took me to the doctor and asked "how can I fatten her up?" I was painfully thin, twig-like and appearing so fragile a good wind might snap me in two. The doctor, a man from eastern Europe, told my mother quite matter-of-factly, "Fat is not healthy." And that was that.

I remained thin into my adult life when I only broke into the triple digits after becoming pregnant at 98 lbs. with my first son. I ballooned up to 160 lb. at the peak of my pregnancy and then by all rights I should have whizzed around the room like a unknotted balloon the way I reverted to my near starting weight, stopping at 105 lbs. after giving birth.

Even though I had quit before during both of my pregnancies, I had resumed smoking once I was done breastfeeding as if only another's health were worth quitting for and mine was either immune to the documented effects of smoking or not worthy of protecting.

But everything changed when I read the Informed Consent. This is the big, thick, War & Peace size document that outlines all the possible things that can go wrong in a particular clinical trial, informing you of every side effect or adverse event that *might* pertain to the study medication as revealed during earlier testing. No matter whether it was at a higher dose, or given to a different group of patients with other health issues or not, they have to fully disclose anything that remotely resembles a possible side effect or adverse event.

That is to what the "informed" part of the Informed Consent refers. You only sign on the dotted line and agree to become a test subject if you have read and understand all the things they tell you about what they know thus far about the medication.

When I read that there was a possibility of a mild "asthma" like condition that occurred at much higher doses with not MS patients but rather kidney transplant patients in an unrelated study, I still worried that twenty years of smoking might place me at greater risk. I'm a hypochondriac after all. Worrying is my job.

So I put down the cigarettes on the 4th of July, 2007 and never picked them back up again. Cold Turkey. Just like that. Knowing that every year, on my anniversary, the whole country would celebrate my milestone with fireworks, I found the willpower (buried in sheer fear, it turns out) to give them up.

That's the beauty of smoking cessation: to stay quit, you just simply never put another cigarette to your lips.

I have discovered, much to my horror, that losing weight is MUCH harder. The same philosophy does not apply. I have to make conscious food decisions every waking minute of my day now that I am facing these potato sacks and trying to rid myself of them. How does one find the courage on a daily basis to do that?

I read the South Beach Diet book the same way I read science fiction: I got to the end and thought "Well, THAT ain't gonna happen."

I tried Slim Fast for a week but decided that wasn't a long term solution either. I needed to learn better eating habits and replace the old ones. Meal replacement shakes weren't the answer.

Then I decided to sign up for Weight Watchers. I'm only on week two and I don't get the whole Points Plus way of assessing foods, but whatever it means, I'm starting to lose weight finally. Plus, without even trying, I'm being tricked into eating healthier. Fruits and veggies, being "free" as they are worth 0 points, are now a major part of my daily intake.

I can't quite put my finger on it, exactly, but I'm sensing that the point system satiates that part of my brain usually occupied by shopping. Getting a free snack of raw baby carrots almost leaves me happy in the same way a BOGO sale does. I got something for free. Yay me!

And so I can see this working. I have a daily budget of points which I can dole out to myself however I like, plus extra points I can dip into during the week if necessary. I have only used up my daily points one time so far, and that day ended with me feeling bloated and uncomfortable anyhow, so it's not likely to happen again.

The only thing is, I signed up for the whole she-bang -- meetings and online tools. So far I have only used the tools (there's an app for that) and have not attended a meeting. I fear going to a meeting and being "judged" by those who think I have no business being there. I know that lots of people need to lose more than I do, and these meetings are their place to commiserate in safety among others who also need to lose an obvious amount.

I am scared they will give me looks that say "how dare you call yourself overweight!" or "How dare you insert yourself into our sanctuary, you obvious outsider!"

Just as fear keeps some overweight folks from doing things where they feel their appearance might matter, I'm feeling that same thing myself. So I won't attend a live meeting because I'm too self conscious.

After a week I have lost 2.5 lbs. and just that half-a-sack-of-potatoes feels so good to set down! I definitely feel a difference in the impact the weight has on my MS symptoms. My legs feel less burdened and tire less easily. I'm not napping all the afternoon away. Maybe it's got something to do with snacking on those fruits and veggies that keeps my sugar level steady, but I feel evenly energetic all day.

No marathon in my future, don't get me wrong. I feel as energetic as your average 50something woman, and that's fine with me.

I will continue to share what I think of Weight Watchers and how I feel my MS is impacted during this journey, but I really think weight loss, however minimal, can have a major impact on how your MS treats you, if you are starting out over weight. You don't realize how bad you feel until you start feeling better. Let's face it, if you have MS the last thing you want to do is lug around unnecessary extra bags of potatoes.

And that's just food for thought. Mmmmm foooooood....