The biotin protocol

I first read about it in an article in 2015 that reported on initial study results presented at the 67th Annual Association of Neurologists conference.  The Biotin Protocol.  Ooh, fancy!
 
Biotin is a form of vitamin B, and it plays an important role in energy production within cells. Researchers believe the compound has no anti-inflammatory action, and thus no effect on relapses, but that it treats disability by tackling neuronal loss
 
I thought at the time it was something interesting to watch and wanting to hedge my bets, I added a dose of the highest over-the-counter Biotin (which I thought was a big dose–10,000 mcg!) to my regular daily meds.
 
High-Dose Biotin
 
Eventually I started to see more articles reporting that researchers were testing high doses of industrial grade biotin in the UK and France.  See here and here.
 
I looked up the actual “protocol” being studied: The protocol, created by the company MedDay Pharmaceuticals in France, tests high-doses of the vitamin Biotin (aka, vitamin B7). It is recommended that a patient take 300 MG of pure Biotin per day.  The trial is attempting to show that high-dose biotin can reverse disability in non-active progressive MS.
 
I finally did the math and realized my over-the-counter efforts were way too low! So I bought more bottles and worked out a schedule where I took 10 pills three times a day just to see.
 
Will Get Rx
 
Reports said trials were set at 1 year which I know from personal experience might not be long enough.
 
I decided that if I was going to stay on this for say three or more years, I should talk to my neurologist and get a prescription.
 
In the meantime, I can report that even with my over-the-counter supply, two months in I seem to have better bladder control.
 
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Jury still out on Ocrevus

The new MS treatment Ocrevus is showing a dramatic reduction in active relapses. But what about the rest of us?

OcrevusLast year my neurologist excitedly told me that a new drug was due to be approved by the FDA in early 2017. So this year, Ocrevus was introduced to the market and I began to read glowing accounts by healthcare providers of how dramatically it cut relapse rates in RRMS, SPMS with active relapse activity, and even PPMS.

The treatment, which depletes a certain type of B-cell, is a close relative of the cancer drug Rituxan (rituximab), but developed from human tissue instead of mouse. Opinions seem to be that it works really well on versions of the disease with active relapses.

What About Me?
That sounds great! I mean, yay, right? But what about SPMSers in the progressive phase of the disease who no longer experience relapses? Like me. It turns out "(w)hether secondary-progressive patients without relapses would benefit from the treatment has not been studied."

Has not been studied?? I hope that instead means there is not yet an immediate way, like relapse rate, by which to gauge positive results in this type of disease. That it will take longer to see changes in disability progression or a slowing of brain shrinkage, for example. I. mean. please.

Safety Issues
Then there are the reports about an odd smattering of breast cancer in the treated group of the clinical trial not replicated in the placebo group which could just be a weird coincidence. Scientists are hoping a larger pool of users will prove it was in fact unrelated.

Also, an MSer taking Ocrevus did recently develop the rare brain infection PML (multifocal leukoencephalopathy). But since he was coming off 3 previous years on Tysabri, one of the MS treatments [along with Gilenya (fingolimod), and Tecfidera (dimethyl fumarate)] linked to PML, the incident was reported as due to Tysabri. Genentech/Roche is currently investigating.

This underscores the necessity of standardizing the advice neurologists give patients on managing a transition to Ocrevus from other treatments. This might require more research as "a switch in treatments was (apparently) not evaluated in the trials."

It sounds to me like still more time and research is needed.

Related links

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On an empty stomach

I have switched medication for my bladder. It says “Take twice a day, 1 hour before or two hours after eating” which seems straight-forward until I started to think about it.

I have switched medication for my bladder.  It says “Take twice a day, 1 hour before or two hours after eating” which seems straight-forward until I started to think about it. 

In the morning, do I take the pill and then wait another hour before taking my other meds? At niwght, when can I eat again after the two hours and when should I take my other meds? 

So let’s take it apart and consider each issue.

One. What am I trying to accomplish?

Research on the web [and I use this phrase lightly and with disdain] indicates that the reason a doctor says 'Take on an empty stomach' is that "…(s)tomach acid and digestive enzymes in the stomach will destroy or damage the contents of the pill. If you take this pill with milk or orange juice, you've started up the digestive process and chances are, the pill is not going to make it to the duodenum without damage."

So if I take the pill when I get up, I shouldn’t eat anything, take other meds, or even drink coffee, for another hour. OK, not happy about that but I got it.

Two. Now, what about the other meds I take in the morning: a vitamin, an herbal supplement and an anti-depressant. Can I just decide to take them on an empty stomach too?

More “research” on the web [killing me!] suggests that I take my vitamin and herbal supplement with food, but not with coffee or any other caffeinated drink. “…The caffeine negates (neutralizes), the effects of the vitamins!…”  So decaf, maybe. But doesn't that defeat the purpose?

And that the anti-depressant “won't absorb into the body properly if it doesn't have time to mingle in your stomach long enough…”

So, no.  Instead I should take the rest of the morning’s meds with food, but not coffee. Oy!

Three. At night, I need to wait two hours after eating dinner and drinking anything other than water to take pill, then no late-night drinking or munchies for another hour, except for water, which I understand.  I never used to eat anything after dinner, anyway.

But then I married OH. And it seems poor form to turn down the half a chocolate bar he tries to share with me at night. Sigh…

Before bed, I take a statin for high cholesterol [genetic] and a different anti-depressant.

Research [aaaargh] shows that I do not have to take the statin at night or on an empty stomach. But I could, with no harmful effect.

So, it seems I should now take both of these with dinner instead since the anti-depressant should be taken with food…

So now, here is my routine:

Wake up.
Get ready for work.
Take bladder med [trospium].
Drink water.
Start work. [working from home now, remember?]
Eat breakfast and take other morning meds. [after half-hour!]
Drink more water or decaf.
Work some more.
Drink real coffee. [after another half-hour!]
Work until end-of-day.
Eat dinner and take other evening meds.
Drink water.
Get ready for bed.
Take bladder med.

Phew!!!


 

Yet another swerve

It seems that I continuously need to educate myself about my central nervous system, my immune system and how every new MS therapy works and what it is intended to do. Although I was never interested in science, I’ve become at least curious over the last twenty years.

It seems that I continuously need to educate myself about my central nervous system, my immune system and how every new MS therapy works and what it is intended to do.

Although I was never interested in science, I’ve become at least curious over the last twenty years. 

I also learned that I could inject myself in the thigh weekly with a 1-1/4 inch intramuscular needle for about 3 years on my initial first-line therapy and then, after I developed severe liver toxicity and had to discontinue that one, daily with a 1/2 inch subcutaneous needle for almost 8 years on the next one.

Although I had always before been averse to taking any kind of medication, even aspirin, once I relented to this I started accepting the drug recommendations of doctors and other health care professionals.

I’ve sat through a 6-week IV course of steroids, a 6-month IV chemotherapy regimen, and two episodes of IV infusion with a second-line therapy.

In the past ten years, I’ve had a liver biopsy, a gamma radiation procedure, and many MRIs.

From one therapy, I learned that it is not more beneficial to suffer through fever and that taking acetaminophen to squelch it is not a cop-out.

From another, I learned that icing the area before I injected, as recommended by the nurse, made it painfully excruciating; using heat instead worked way better.

This underscores the idea that what works for one person does not work for another.

After my allergic reaction to it has disqualified the most recent therapy, I am now poised to try the next one, a new oral medication for MS.

Before I start, I have to go for an optical coherence tomography (OCT) test, an EKG, and a skin-cancer screening.

Like I said, I will now need to educate myself on this drug and why I need these tests.  Watch for future posts!

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Scratch that, literally

In February 2005, I went for my first infusion. In October 2011, I finally got my second. Then, in November, I started to get my third…

In February 2005, I went for my first infusion of a powerful new drug that was being used in cases of MS where nothing else had shown to be effective. 

[As I've said, there is still no cure for this disease; 'effectiveness' in slowing progression is the goal right now.  Unfortunately there is no proven test for that either.  We rely on regular MRIs of our brain and spinal cord, examining results in comparison with earlier scans, to 'guesstimate' progress or lack thereof.  But I digress…]

I had to be infused at a chemotherapy center, and I remember sitting there, feeling somewhat guilty and embarrassed that I wasn't fighting for my life, 'just' my mobility and coordination.  It was a Friday.

On Monday morning I was watching CNN, when I saw scrolled across the bottom of the screen that this drug had just been pulled off the market because it was implicated in several patient deaths from a rare and frequently fatal viral infection of the brain.

Shocked and feeling sorry for myself, I called in sick to work and spent the next few days on my boyfriend's couch, eating pints of ice cream and watching the 24-hour cable news.

Fast forward to March 2011, and a new neurologist who told me about a new finding that could definitively tell whether a person was even vulnerable to the infection or not. 

She just wanted me to have my blood tested for certain antibodies, the presence of which would indicate that they had been manufactured by my body in the past to combat a previous infection, like tonsillitis, for example.   

Once they had begun to be created, they could remain latent in my body and then mistakenly attack again in this case, which would leave me with an even more severe immune deficiency and vulnerable to this deadly virus.

In May, I got my test results back.  I had tested negative and she excitedly told me that she wanted me to start this infusion therapy as soon as possible.  I was sheepishly and cautiously hopeful.

Sheepish because when the suspension of the drug had been lifted in 2006, it was after my neuro had already gone on to the next 'drug of last resort' [in my case the chemotherapy drug, Cytoxan]  which, sadly, didn't seem to work, either, and he did not want to risk having that 'on board' with this.

So when I began to receive glossy marketing swag in the mail for that drug, I became incensed and posted a blog entry about how patronizing I found it that this company would try to get patients to demand this from their doctor.

By now I had already talked to a lot of callers on the helpline who were on this medicine and reported that, while nothing else they had previously been on had worked, this did.  For the most part, they were satisfied and I got the impression that doctors were happy to have it back, too.

Consequently, I got my first infusion in October and it went without incident.  Optimistically I requested approval to begin paratransit service to shuttle me back and forth to monthly infusions.  A few days ago, OH took me for my November infusion.

A few minutes into the drip I got flushed and then started itching uncontrollably.  Alarmed, the nurse discontinued the IV right away, gave me water and a Benadryl, called my neurologist, then started a prednisone IV.

While at first I assumed that I'd be permanently prevented from this treatment, too, my latest readings suggest that this reaction would not be uncommon for a patient receiving re-treatment with it after an initial, short exposure, then a 'break' of therapy [like, oh, say six years??] followed by re-exposure.

So I don't know what the next step is, but I will see the doctor on Tuesday [and wouldn't you agree that this has been quite a year?!].

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A tale of two (MS) pathologies

A friend recently forwarded me an article from the Inside Stanford Medicine newsletter. It seems that a small, recent study showed that there may be two different schemas for MS. 

So MSers’ responsiveness to the available therapies, and interferons in particular, might depend on which pattern of MS we have.

This totally fits with my experience: my disease has never seemed to be halted by the meds, or even overpowered temporarily by steroids.  Even chemotherapy didn’t seem to have any effect.

And when my neurologist told me that in his opinion I had transitioned to secondary-progressive, I thought “Well, duh?!  I’ve been thinking that for several years now!”

In fact, this study may be suggesting that I’ve been progressing since day one, that although my diagnosis was Relapsing-Remitting Multiple Sclerosis (RRMS), it may actually have been some progressive form all along.

In truth, once getting this diagnosis 20 years ago, I suspected that doctors often gave the diagnosis as RRMS then they could prescribe one of the first-line drugs for MS that are only approved for this type.

MS medication is so expensive and has required self-administered, regular shots, sometimes as often as every day.

This study seems to confirm for me that giving myself the regular, sometimes painful, shots did nothing to slow the progression of my disease.

And that’s the mystery for all of us: there is yet no way to measure the effects of any of our medicines.  I have no way to measure this, so I only have my gut feeling.

My doctor agreed that the latest medication I was administering faithfully had obviously not impeded my progression, so we agreed that I should stop.

The silver lining is “Yay, no more shots!” 

On the other hand, “Whoa, no more shots. Of any kind.”

He explained to me that prevailing theory at the moment is that MSers who transition from RR to SP eventually reach a plateau and that we can hope that I’ve already reached it.

He did arrange for me to try a new oral drug for MS, A——-, which helps some of the affected walk more confidently.  I’ve been taking it for two months now but have experienced no change.

If the results are replicated by other labs and larger studies, MSers may someday be able to take a blood test at diagnosis to see which type they have.

It’s another small piece of the puzzle.

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Biologics, generics and orphans…Oh, my!

I am currently vexed about two healthcare issues.  I figure this is the perfect time to mull aloud, that the more people who are thinking about these things the better.  And hopefully we can influence the debate this year on healthcare reform.

First is the inability to create and sell generic biologic drugs in this country because the "Food and Drug Administration (FDA) does not have the authority to review applications for generic versions of biologic drugs like other countries do."  I always wondered what the issue was; now I know.

Isn't the U.S. supposed to be all that and a bag of chips, as OH would say?  How incredibly disappointing.

"Four of the six MS therapies are biologic drugs, which are drugs produced from living cell cultures rather than synthesized chemicals." MS sufferers must  "pay between $16,500 to more than $30,000 a year for their medically necessary drugs." Without the possibility of generics on the horizon, drug companies that produce any of these drugs essentially enjoy a permanent monopoly.

[Digression: the term "medically necessary" bugs me.  There is no cure so doctors can only recommend these for slowing down the disease. This isn't a necessity, it's a crap shoot.  Also, not every drug works for every person.  For example, I received a letter this year from my health insurance company that my injectable will no longer be in their formulary so I should switch to one that is.  But because I had developed a liver toxicity to all others, this is the only one left to me!]

The second is the idea that any drugs for M.S. are "orphan drugs" which, according to Wikipedia, are drugs that have been "developed specifically to treat a rare medical condition, the condition itself being referred to as an orphan disease."  (In the U.S., "rare" equals fewer than 200,000.)

The National Multiple Sclerosis Society maintains that there are only about 400,000 cases of MS in the U.S., up from 350,000 a few years ago.  But I, and others, believe the number is much higher and that maintaining it is less is a way to keep these drugs defined as quasi-orphan drugs with tax incentives and extended protection from competition.

As a country we should have, and MS activists have been pushing for, a national multiple sclerosis registry, a coordinated system to collect, analyze and track data on multiple sclerosis, like the one I've already been participating in.  (See link to NARCOMS below.)  This would prove our numbers.

As I've posted before, I worry about healthcare.  Well, I worry about healthcare when I'm able to.  When I'm not totally consumed with being ill.

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Chemo and hot flashes

Starting in February 2006, I did a 6-month chemotherapy regimen to attempt to weaken my immune system.  I went once a month and sat for a 4-hour IV infusion of the drug cyclophosphamide (brand name Cytoxan®).

I was warned that the treatment might cause hair loss, nausea, and push me into early menopause.  I was told not to have children (as if!) from then on.

Sadly I didn’t feel much different in the end.  My energy was probably better; I can’t remember now.  I appreciated the attempt and would’ve been overjoyed if my disease was significantly lessened. 

My morning routine now is to get up and work on my computer upstairs until my husband gets up and makes his way downstairs for his morning ablutions including making coffee. 

I lurch downstairs and settle into a chair facing the T.V. and turn on the news.  OH heats the “corn bag” for me in the microwave, fixes me a cuppa joe and then gives me the warm bag and my loaded auto-injector.

[Digression: when I started doing daily injections of this M.S. therapy, I was advised to ice the area before the injection.  But Owwwwwwwwwwwwwww!!!  I have since found that heating the area before and after makes it much less painful. I was careful to ask around to various healthcare professionals before changing from cold to hot but no one had heard of any reasons not to.]

Despite shots of this med, my disease is still progressing.  Oh, and now I’m starting to have hot flashes.  Sigh.

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Go ask Alice…

One pill makes you larger
And one pill makes you small…

— Jefferson Airplane, White Rabbit

I finally gave in (to myself) and asked for a prescription for tolterodine. I started taking it a few weeks ago and have been grudgingly, reluctantly satisfied with its effect on my bladder. But as with any new med, I fret.

This now brings my current chemical regimen to five: glatiramer acetate by injection, tolterodine, simvastatin, bupropion and sertraline in tablet form.

[Digression: using the generic names pleases me and is purposefully catty.  Not using their brand names somehow belittles them.  Wait, can drugs be belittled?] 

When I first went to my therapist, I was adamant that I didn’t want “head meds.”  I guess that’s a common request.  But I felt hopeless and couldn’t stop crying.  Months later she broached the possibility of medication again.  She insisted that my quality of life should be important to me. 

Now, with a little tinkering, we’ve settled on a mix of bupropion and sertraline for me.  I’ve subsequently learned that the incidence of depression is way higher in people with M.S. than even for others with different chronic diseases.  The thinking now is that it may be a result of the plaques forming in that part of the brain.  So that’s numbers one and two.

Furthermore, I am genetically susceptible to high cholesterol.  That is the excuse I gave my GP when I wanted a simvastatin prescription.  In reality, I was urged by another person with M.S. to take it, that he had experienced an almost complete remission after artificially raising his cholesterol to get it prescribed.

For me, I didn’t see the harm in starting to address the high-ish cholesterol, but I haven’t noticed any changes in my M.S. symptoms.  That’s number three.

In years past, I’ve performed the interferon beta-1a injections but developed a severe liver toxicity also known as hepatitis C.  I was yellow and had to go on short-term disability to stay home for two months and get my liver enzyme count back down.  I went for blood tests every 2 weeks and it rendered me ineligible for all other M.S. approved interferons.

But the consensus of the medical community is that because there is no M.S. cure yet and also there is no definitive way to determine the severity of the progress of the disease, I should be on any of the currently approved drugs “likely to reduce future disease activity and improve quality of life” for people with M.S. So in 2003, that left glatiramer acetate for me and that is number four.

In addition, a few years ago I sat for an I.V. course of methylprednisolone (steroids!).

Another time I sat for an I.V. of natalizumab on a Friday and was horrified when it was pulled off the market the following Monday for health concerns.  It is now back on the market but it didn’t show significant changes to my MRI so my neurologist and I have decided to hold off on resuming it.

Oh, and I had a six-month round of the chemotherapy drug cyclophosphamide, also administered by I.V. 

So I guess I just talked myself down.  From the moment I decided to start the interferon beta-1a injections, I was admitting to myself that I was willing to accept medication “on board” in my adult life.

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