Flummoxed (Part 2 of ?)

I find it super uncomfortable to read articles in scientific journals. Even articles about MS. Even articles about MS illustrated with lots of pretty graphs. Maybe…especially articles about MS. These are articles I have to understand as though my life depended on it. Because it does.

You know how some people publicly (and most people privately) grouse about how higher math is irrelevant for most of us after we get out of school—so why make students suffer? Well, I wish I’d paid more attention when I was taught statistics. Turns out, I need to understand them in real life. I wish I’d had a semester or so learning to become a fine print detective, that the teacher had made terms like  “de facto” feel like shiny keys to hidden treasures. I wish I’d not learned to gloss over any text in the form of an equation like this one:

IDPDrugversusPlacebo=100%(1(1IDPDrugversusIFNβ100)(1IDPIFNβversusPlacebo100)).

Because no one is going to tell me the stuff I am learning by reading research articles in Frontiers in Neurology. Stuff like: “Higher efficacy treatments exert their benefit over lower efficacy treatments only during early stages of MS, and, after age 53, the model suggests that there is no predicted benefit to receiving immunomodulatory DMTs (Disease Modifying Treatments) for the average MS patient.”

I admit, I haven’t been going to enough MS Society events. But all too many of them are paid for by pharmaceutical companies, who may have a conflict with informing you that, after you reach a certain age,  their drugs are no longer particularly useful. (Not to mention, some of their drugs are not particularly useful at any age.) I don’t know about you, but I know an awful lot of people over the age of 53 who are taking a DMT (Disease Modifying Treatment.) These treatments can cost in excess of $7k per month. Very few of these people seem particularly well. More than a few complain of side effects from their medications. What would they think about this article? Have they been enduring pills/injections/infusions that are doing them more harm than good? Have I?

I’m not going to be too hard on myself for having trouble navigating the facts as presented. At one point, I’d sent a link to my son, who majors in math and economics at Vassar. My heart leapt when he messaged me back. Then I saw he was messaging with a question, not an answer: “Does this thing have cliff notes?”

When Dr. Z returns my call, I am stuck on one particular paragraph, which distinguishes higher efficiency drugs from lower efficiency drugs. I notice the drug I’ve lost access to, Zinbryta, is classified as a higher efficiency drug. Whereas Tecfidera, the drug that is causing my skin to redden and prickle, is classified as a lower efficiency drug. I’ve downgraded! Nobody likes a downgrade. And nobody likes their skin to prickle and burn.

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Dr. Z tells me he’d gotten the picture my friend Monica had taken of my angry skin. I ask him if it looks like an allergic reaction. The fine print that came with the drug was very clear on one thing: “Do not use Tecfidera if you have had an allergic reaction, such as welts, hives…”

I want him to use the word, “hives.” Instead he asks, “Did you take aspirin thirty minutes before you took the medication?”

“Like you told me?”

“Yes.”

“No.” I hadn’t wanted to mask the effect of the drug. I’d wanted to know exactly what my body thought of it. The reaction had been fairly unambiguous, I thought. Didn’t he?

He says rash is a common side effect, one that would generally recede after the first few weeks, or could be averted entirely if I were to take an aspirin beforehand.

I counter that even if this was a side effect, and not an allergic reaction, I just wasn’t sure the side-effect of this drug could ever outweigh the benefits of a low-efficacy therapy.

He says, “You’re talking about that paper again. Let’s remember that you may not need a high efficacy drug at this point in your disease process. You might be past the inflammatory phase of your disease. But you are not out of the woods yet. I have patients in their seventies and eighties getting relapses. I wouldn’t want that to happen to you.”

I don’t want that to happen to me, either. I promise I would give Tecfidera another chance. I would try taking the aspirin 30 minutes before the drug, as he had told me. And wait and see.

 

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Flummoxed (part 1 of ?)

I took my first Tecfidera pill one week ago after dinner. About three hours later, I sat up in bed next to my soundly sleeping husband: it felt like I was wearing a prickly cap of molten lava. I sat there very quietly for a hours, a red-hot target,  wondering what to do.

Dr. Z did say that “facial flushing” was a common side effect of the drug. He had suggested I take an aspirin thirty minutes before taking Tecfidera. But had I done that? No. I had a rationale:  I always plan on not getting the listed side effects. I am as suggestible as the next person, which is to say, wildly suggestible. I try to compensate by kind of not paying attention to the fine print until I have to.  I have enough going on with my health without taking on any unnecessary burden of invented symptoms. By this semi-logic, taking an aspirin would have been given too much credence to a possibility of a side effect I’d rather not invent. Alas, I got the side effect anyway.

And then some.

As I sat there, sweating, burning, I thought, This cannot be good. Nothing feeds the demon of multiple sclerosis like elevated body heat. It makes symptoms leap into action like bacon grease on skillet. I realized I hadn’t even asked about the mechanisms behind how the drug worked. What if it didn’t work for me at all?

I was aware—and you may as well be aware, too—that MS drugs work less and less effectively as a patient gets older. I used to suspect that the daclizumab which had worked for me so well for me as an infusion in my thirties was simply less effective in the Zinbryta formulation I injected in my forties and at age fifty. But no. As it turns out, my cells were getting less effective. Here’s a link to a paper that illustrates it all beautifully. The paper is an easy read if you are fluent in statistical and neurological terms. Which I am not. But even I can read a graph with a steady downward angle and notice there aren’t even many people my age in MS drug studies to begin with. And when we are present, we make the results look a lot less spectacular. Long story short: If you want an MS medication to work at its best, be younger.

I wasn’t getting any younger. The new pharmaceutical options invented during my twelve years on daclizumab were turning out to be mostly inaccessible to me. My elevated antigen, and the associated higher risk of potentially fatal PML,  eliminated many of the new high performing drugs.  My elevated cancer risk eliminated Ocrevus, the only drug with promising results for people with progressing multiple sclerosis. Yes—I’d learned in an email from Dr. Bielekova that I am progressing. She’d written:

We also know much more about FDA-approved MS drugs in general then we knew when we met: these drugs are not a cure. Their efficacy is highest when they are started very early on in MS, but declines afterwards. They do not penetrate well into the brain tissue, where the inflammation hides. This type of inflammation we call “compartmentalized inflammation” and it is not inhibited by current MS drugs. You have some of this compartmentalized inflammation.

It had been validating to read that. I’d known it was getting more difficult to function, even as the MRI’s failed to reveal any new lesions. I’d known…deep in my cells, I guess, that those MRI’s weren’t telling the whole story.

And I knew, as I sat there and burned, that Tecfidera wasn’t going to do a thing for the compartmentalized inflammation caused by this latter phase of MS. At best, it would fend off the cruel, lesion producing exacerbations of my earlier phase of MS. It has been years since I’ve had to contend with one of those. But as Dr. Z put it, I was “not out of the woods yet.”

I’d been, briefly, on Dr. Bielekova’s trial of drugs that could possibly address the compartmentalized inflammation, but I’d had to withdraw from it once Zinbryta got pulled from the market. I could not return to the NIH (National Institutes of Health) until I started a new medical regimen. As the sky lightened, and the burning receded, I was thinking Tecfidera would not be the drug for me.

How did I wind up dutifully taking my next dose of Tecfidera that morning after breakfast? What persuaded me to give the drug another chance? I don’t believe in giving drugs a chance—not if they come with side effects. Back when Avonex came on the market in the ’90’s, I promised my then-neurologist I would give the drug a full year. I stopped breastfeeding my son to go on that drug. Those weekly Avonex injections gave me “flu-like symptoms” of fever and bone ache that lasted half the week. For my troubles, I got two severe MS exacerbations before that first year was through. I quit after the second exacerbation. The bone ache plagued me for years afterward. I’d felt like such a sucker.

Nothing happened immediately  after I took the pill. I played with my dogs, pulled some weeds, and went to yoga. My friend Monica and I were halfway through lunch when I asked her if my face was getting a little flushed. She said, “Now that you mention it, you’re bright red.” As we were leaving, she asked if I thought I could drive home safely. I said I’d be fine. But once I sat in the car, I looked down and saw my legs were red. I  ran across the parking lot, rapped on her car window and asked for a hug. She was out of her car in a flash.

Monica noticed my legs were “a funny pattern.” I will spare you the photograph she took. It matched the photo Google gave me when I typed in “hives.” I’d remembered the information packet explicitly said not to use Tecfidera if you have an allergic reaction. This looked like an allergic reaction to us. Monica insisted I call our neurologist, insisted on remaining by my side. She stayed with me as I left all the information with the clinic. Then I went home, and went on a research tear. By the time Dr. Z. called me, maybe a scant hour later, I was toggling between screens on my computer: my medical records,  the Tecfidera Facebook page, the Important Safety Information page on the drug site,  two challenging articles in the Frontiers in Neurology site. I was overwhelmed. Flummoxed.

Was what I had a side effect, or an allergic reaction? And did it really matter? My body didn’t like this drug. Twenty plus years of yoga and even more years of multiple sclerosis, had taught me to listen to my body.  Yet there was too much at stake to respond with mere intuition. I was eager to listen to my neurologist.

 

 

 

 

 

 

 

 

 

 

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just my luck

A New Chapter Begins

Before I took my first dose of my new MS medication, my husband thanked me for making a wonderful soup. “If you die, you’re leaving on a high note.”

If anyone wants to snatch a loyal husband after I go, you should know the wonderful soup has a base of two cups of last night’s leftover fish soup from the local Chinese restaurant, one diced green onion, one cup of  home made bone broth, one can of full fat coconut milk, one cup of assorted frozen Costco fish, one teaspoon of pulverized ginger, a sprinkle of turmeric, half a cup of dulse,  and one other secret ingredient I won’t reveal because my husband said it was “comforting.” I want him to miss me just a little.

And I don’t want him to have to miss me quite yet.

To that end, I picked one of the MS medications least likely to provoke a fatal case of progressive mulifocal leukoencephalopathy (PML) because I love our life together very much. (That same life I once found so cursed by disease way back when I was objectively far less disabled than I am today.)

My local neurologist, Dr. Z., said that this is the drug he would choose for himself or his wife. There’s no stronger recommendation than that.

I am giving Tecfidera a shot. Thankfully, it comes in pill form.

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just my luck

No Cancer.

I met with my surgeon yesterday. She inspected the pretty scar she’d left me, and we agreed that it was healing very nicely. She told me those suspicious looking cells she’d extracted had turned out negative for carcinoma.
I mistook this for good news. No cancer. No worries. Right?
Wrong. The surgeon asked me if I wanted to know the results of my Tyrer-Cuzick Breast Cancer Risk Evaluation, then ducked out of the examining room before I had the chance to answer. She returned with a four page document that concluded with results she and I read very differently.
She’s the surgeon. She’s got the medical degree. I’m the patient. I’ve got the MFA. I’ve never been good at math.
The results were as follows (capitalization theirs):
“Ten Year Risk:
This woman’s Risk (at age 50): 11.0%
Average women (at age 50): 2.7%
Lifetime Risk:
This woman’s Risk (to age 85) 39.9%
Average woman (to age 85) 11.4%”

Maybe I’m a glass-is-half full person, but even if I wasn’t: the ten year prognosis glass is 89% full. That’s pretty darn full.
The surgeon immediately offered me a medication I could take to fill that glass to 100%—a medication, she swiftly added, that could only be taken for five years.
“No medication,” I said. “I take enough medications.”
“If you want to reduce your risk to zero percent,” she offered, “you can get a double mastectomy.”
I didn’t say, “And lose that pretty scar you left me?”
I didn’t roll my eyes. For while I did think her suggestion was crazy, I understood she was coming from a crazy place, witnessing women being brave because they have to be, as they fight for their lives, and all-too-often lose. I took it as a kindness, really, that she didn’t want me to join their ranks. I don’t think she’s an opportunist, trying to make money from some ounces of my flesh. I went along and booked my appointment for another mammogram in six months.
And then I went about my life. I took my “Freedom from Falls” class in the morning. I ran the writer’s workshop at the Senior Living Center in the afternoon. I told the writers my odds. These writers are in their seventies, eighties and nineties. They’ve seen a lot of life. They’ve seen a lot of death. They all agreed with me: those odds looked pretty darn good. I drove home. I did not update my neurologist. I did not update the NIH. I did not update my blog.
I wanted one day of those numbers looking pretty darn good.
If I go ahead with my plan to switch to Ocrevus for my MS medication, those numbers would go up. There’s a bullet point on the Ocrevus site under “WARNINGS AND PRECAUTIONS”
“• Malignancies: An increased risk of malignancy, including breast cancer, may exist with OCREVUS”
What would my surgeon’s Tyrer-Cuzick Tool have to say about Ocrevus? What will my neurologist have to say?

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Lab Rat Plot Twist: Zinbryta Pulled Off The Market

I was on the line at the post office when one of my local MS doctors, Sandra Parawira, called to give me the news before I heard about it through the media.
Zinbryta, the MS drug that has staved off my MS attacks for the last 12 years, had just been pulled off the market. A few Zinbryta patients in Germany, and one in Spain, were found to have developed encephalitis. Sandra urged me to come into the office to visit with her on Wednesday. If her concerned tone of voice hadn’t done enough to convey the urgency of the situation, the immediacy of my next appointment in her busy practice surely did.
But was I worried? Not particularly. I have NPR to thank. On my drive to the post office, I’d been listening to an interview with a medical researcher on Science Friday. The researcher, Dr. Kang, was promoting a new book about “cures” throughout history that had done more harm than good. As I listened to Dr. Kang recount Marie Curie’s fondness for the radium which would later kill her, I’d idly wondered which of the drugs or supplements I was currently taking would later be exposed as a toxin. Five minutes later, I got the call that the drug I’ve credited for giving me my life back has been taken off the shelf.
While I have my doubts that a drug I’ve taken safely for 12 years was about to give me encephalitis, I am still seeing this change as an opportunity. Many new players have entered the MS landscape in the 12 years I’ve been on Zinbryta. Perhaps the drug I’m assigned next will improve my life as drastically as this one did.

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Disclaimer

Gentle Reader,

Never forget that this blogger’s brain has shrunk to the size of a side dish of cauliflower. Lectorum admonere potent. Or, Reader, be warned. (Don’t feel insecure, bigger brained one, if you didn’t know the Latin. I didn’t, either, I had to look it up.)

 

 


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I got Swanked. Then I Wahled. Now I’m Galled.

 

When I started the trial to determine which diet was better for people with MS—Walhls or Swank—I’d promised the good people at the University of Iowa that I would not reveal which MS Diet I’d been assigned to until my participation in their clinical trial had ended. My contribution to trial has been completed. Drumroll, please.

I’d been assigned to the Swank Diet. For 36 weeks, I wrote a record of every morsel of food that passed through my lips. I ate no red meat, no avocado, no coconut in any form. No fats exceeding four teaspoons a day. I ate at least two servings of fruits and two of vegetables a day, as well as a minimum of four ounces of low fat protein, such as chicken breast. I drank no sodas, ate no sugars, no transfats, no deep fried food (OK, I cheated once and ate one half of the best falafel ball of my life.) I took the assigned five supplements: 1 tsp Carlson’s unsweetened cod liver oil, 5000 IU Vitamin D3, 1000mcg Methyl B12, 1000mcg Methyl Folate, and a Nature Made Multivitamin for Him 50+ ¯\_(ツ)_/¯.

I was to drink either skim milk (yech) or some milk substitute every day. After trying soy milk, then rejecting it based on scary stuff I read online, I moved on to rice milk, which I then rejected after reading more scary stuff online. I then turned to nut milks, which were a) yum and b) a little fatty…but by that time I’d lost more weight than the study wanted, so I’d hoped that would make drinking nut milk OK. I turned to the study nutritionist, who is supposed to help… but oddly enough, she deferred answering my nutrition questions until she’d checked with her boss, Dr. Wahls, who then expressly forbade her to guide me. Which led me to suspect… nothing nice. Dr. Wahls has a vested interest in the subjects given the Wahls Diet to succeed, and the Swank subjects to do poorly. Which is why I think it undermines the legitmacy of this very crucial study to have her at the helm. Well, Dr. Wahls, I did poorly.  Dr. Wahls calls those who follow her diet Wahls Warriors.  I guess I’ll consider myself a Wahls Martyr.

On my last study visit, the nutritionist asked me what advise I would give myself if I were just starting the study. I responded immediately. From my gut. I said, “Don’t do it.”

Aside from keeping track of what I ate every day, I had to keep track of my energy levels and my pain levels every day. My energy levels had gotten lower over the course of the study, and my pain levels remained fairly high.  The Swank Diet wasn’t right for me. It might have been a real improvement for another person with MS, someone who perhaps had weight to lose or had genuinely unhealthy habits to unlearn. But through thirty six weeks of deprivation of healthy fats, I’ve come to appreciate healthy fats all the more.

My first meal as a free woman was an avocado. I let bygones be bygones, and jumped right in to the Wahls Diet, diving right past level one to level 2/3. Thanksgiving came and went, and I ate (and abstained) as a Wahls Warrior should. Turkey? Yes! Organ meat? Yes! Good fats? Hell, yes. Neapolitan pizza and cannoli from New Haven’s renowned Wooster Street? No, thank you.

Was it worth it? It seemed like it. My energy level rose immediately. My pain level went down. I thought, This is the beginning of the rest of my life.

My new life lasted… ten days. The evening of Day Eleven, I got a fever. My side ached. Had I pulled a muscle in the gym? My whole body went cold. My fever worsened. I shivered. I called my primary care doctor the next morning. By the time I went in to see her, my fever was down. My side was still tender. Turned out, my white blood cell count was scary high.  My gallbladder scanned very clearly… and all they saw were some polyps.  My white blood cell count has since normalized, so I’ve opted for a wait-and-see approach instead of further scans. What did this incident mean? There are no clear answers yet. My gallbladder is still tender. My doctor has advised me to stay away from fats.

So for now, I’m on Wahls without the fun…I mean, the fat. Which is basically Swank plus organ meats plus seaweed. And no, I’m not chanting to myself, This is the beginning of the rest of my life. Though technically, it is.

Eat well, folks. Whatever that means for you. Stay healthy!

 

 

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