How an MS Clinical Trial Changed My Life

In 2001 I couldn't walk or see unassisted. MS hit me hard and fast. Life changed for the worse, then it changed for the better.

Self-care includes walking, strolling, yoga and
exploring while being compassionate to my and my MS!

People often asked me what it was that inspired this change. It all started when I was included in a clinical trial way back in 2001. It was a trial for an actual vaccine, a T-cell vaccine by Dr. Leslie Weiner at USC. I basically started looking into a more holistic approach to taking care of myself, using more self-care.

Yoga has always been part of my regime and I suffer without it. Keep it up!

Joining research

During this time there were only three approved disease modifying treatments (DMTs), all injectables. I was on Copaxone but my tests were showing progression. My medical team wanted me in this study.

Because the MS hit so hard and fast, I didn’t know what was going on, but knew that I needed help. Newly diagnosed I was so curious about this disease and what I could do to help. Twenty years ago there was not much information available about living with MS. Today there is much more good research and many more stories available.

Because it was a double blind study, I didn’t know if I was on the "vaccine" or the placebo so I took everything into account to focus on self-care. We did not use that term back in 2001, but that's exactly what I did. I spoke with my doctor, called friends, other MSrs, experts and did a lot of research. I found what works for me from acupuncture to yoga, from supplements to diet and lifestyle changes.

my moment of zen....enjoy everyone of them!

Supporting myself and others

I was so excited to be helping others with research and potentially helping to find a cure that thoughts of residual benefits didn’t come to mind. But soon I found myself studying holistic nutrition, becoming certified as a life coach, getting more into my yoga and other practices. I was not on a DMT so everything I did mattered, or so it felt that way to me. During the study I was under constant care, with regular MRI’s, occupational therapy and other classes and medical reviews. It was a journey of exploration and learning.

It was because of this trial that I started GirlWithMS.com. I wanted to share my positive result of finding new life hacks for self-care with everyone associated with MS.

There is much attention that we can put on ourselves to help us move forward in life, from working with doctors, using disease modifying treatments, finding natural, holistic approaches, and joining clinical trial and seeing what research is going on in the medical world.

Another thing that I discovered was that I could really nerd out on research. It's absolutely fascinating looking at trials and studies and seeing what these neurologists and others are doing to help the lives of those living with MS or preventing it in others.

Exploring different kinds of research

Research and clinical trials run the gambit in size and activities. Some are remote, some must be near certain facilities. Some might be sponsored by a pharmaceutical company testing a new drug and others might be from a university looking into the potential causes of MS.

There is something to be said about being part of a trial or research. To be part of that experience that could find answers, that could help others live better, or even yet, find a cure for MS.

At one point I was complaining to a cousin about the amount of MRI's and reviews my studied required. Quickly stopping me in my tracks, he said, "you're doing it for you, for science and you're doing it for others,” ringing a sharp bell in this noggin and I kept on.

As more research is performed on MS, the more chance we may have for finding a cure. Yay! But in the meantime, if it's your thing, it’s possible to help by becoming a part of a trial that works with your location, schedule and type of MS.

Learning to understand the genetics of MS

There is also a growing volume of research looking into how genetics (DNA) impacts different conditions, including MS.

One company that I find interesting is Sano Genetics in the UK. Sano’s mission is to accelerate the future of personalized medicine by connecting people to research opportunities, with a particular focus on better understanding the role of genetics in different conditions.

I had already collected a copy of my DNA data while doing genealogy with another company, so I simply downloaded it from there and uploaded to Sano Genetics.

By uploading my DNA data to Sano I was able to explore research opportunities that might be relevant to me, based on my health information and DNA data, as well as discover my free Personal DNA Reports - which show how my DNA influences traits such as my eye color and caffeine intake.

Plus, data security and transparency about how your data is used are a big part of Sano’s philosophy. You can always control which researchers get to see your data, and can change this or delete your data at any time by simply changing your account settings.

Sano has a growing team of MS advocates - as many of us have found research, information and genetic material through their efforts. We call ourselves the #SanoCommunity. Kinda makes me feel like a superhero kid again or something.

But most important is that I wanted to share my experience of participating in research, as you may find it interesting to explore and join some of Sano's research projects. Find out more.

#ThisisMS #TakeTHATms #TeamSano #DNA #Research #MS #FindaCure

Me and My Cubii: a Convenient Exercise for MS.

On frequent occasion I am asked to review a product. They’re often sent or mailed and sometimes they are great and sometimes a flop.

I was rushing through a bunch of emails one day and responded to an email from Dave at Cubii. OK, Dave, sure, go ahead and send me your product. I was moving so fast I never did prepare myself for what was to come.

Well, a pretty hefty box was delivered to my front door. Hmmmm. I really didn’t remember it was coming.

On the outside of the box was an image of a small stepping machine.

My interest was piqued. What is this and how could it help me?

Intimidated at first, I walked around the box for several days.

Then, one day when feeling especially strong and curious, I pulled the box out of the hall and into the familiar room. And slowly I began to unbox the gift.

I was expecting a much bigger project. I’m still laughing at how easy it was to unpack and set up the Cubii.

First of all, everything is simple, easy and well-marked. The box even comes with its own screwdriver.

I don’t think it took even five minutes to put together.

The Cubii is so easy to set up - Check me out:

I’m not one for too many gadgets but for someone with balance issues and heat sensitivity, this little device came just in the nick of time. In fact I was just grousing about the 90F weather and how I was needing some exercise.

So, I plopped my bum down on a comfy chair and started walking away. Seemed like a great time to watch TV, so I turned on some cooking shows. Oh, how I love my cooking shows!

Ten minutes was done in no time. Wow. OK. That was easy!

I don’t have a desk that will work with the Cubii, because that would be cool. Walking and writing at the same time without any chance of falling.

My Cubii sits in front of a comfy chair in the den. I don’t spend much time there but it’s a nice space. I can Cubii while watching TV, talking on the phone, playing games on my app or even reading. The exercise is very gentle. When my legs are stronger, the tension can be increased to make a more rigorous workout. For now, I’m into gentle.

Interestingly, my knees felt great after this little workout. The angle seems quite beneficial to my weak and damaged joints. My core is also used while walking. These pictures show it best:

It’s super easy:

I told my neurologist about it and she was psyched. I am too!

Now its a part of my morning routine. Cup of decaf, some morning news and my Cubii. Thank you, Dave, for reaching out to me! I appreciate the sponsorship!

For more information about Cubii click HERE.

This post was sponsored by Cubii. Thank you for helping those with MS live better!

Resilience and MS - Life Coach Sessions Coming Up!

Are you just surviving or are you thriving?

I recently found that surviving had become my focus. I had lost sight of the thriving aspect of life. It was time to make a shift toward positive awareness of the resiliency I have within me to make a difference with my MS.

Life throws us many transitions and it's not easier with MS, but we can and will get through them. What are these transitions? Anything from the diagnosis to having children to working to just living.

Can Do MS is an organization that's making a difference in many people's lives, especially mine! During these pandemic times my resiliency seemed pushed to the limits. But the folks at Can Do MS have this exciting year long plan to keep us all in top form with our MS for 2021.

On March 17, I took part in a life coaching session with Rosalind Kalb, PhD, and about 100 folks with MS. It was amazing. We broke out into rooms and had some great in-depth discussions, after learning some important tips and tricks to deal with our MS and all the personal transitions we go through. It was eye-opening, supportive, safe and comforting.

Our next Coaching Session is March 30:

Register today for Building Resilience to Overcome Setbacks, Tuesday, March 30, 6pm ET by clicking here.

Upcoming Programs

During March we are exploring resiliency in MS transition and exploring everything from articles to JUMPSTART programs to Coaching and Webinars.

We'd love to see you join us during one of these interesting events. I'll be speaking again at the coaching session on March 30. (Link above)

ARTICLE

STAYING RESILIENT TO MS TRANSITIONS

By: Matthew Sacco, PhD, Megan Weigel, DNP, ARNP-C, MSCN

The term “resilient” has become increasingly more a part of our mainstream and popular culture vernacular. It is a term that conjures up ideas such as determination, strength, and fortitude. But, when it comes to living with a chronic condition such as Multiple Sclerosis (MS), what does resilient really mean?

click for more...

JUMPSTART

Register Today for a Virtual JUMPSTART® Experience

During these uncertain times, Can Do MS is thrilled to offer our popular JUMPSTART Program virtually.
Find connection during isolation, learn from healthcare professionals, and explore resources to help your family thrive with MS - all from the comfort and safety of home!

2021 Virtual Programs

Join us for our live, online JUMPSTART programs!

It's easy to get started!

Register (for one or all programs) at no charge!
Connect with MS experts in real-time during the live program which features a Q&A panel and group discussion.Space is limited. Register, log on, and JUMPSTART your best life today!

Can Do MS creates monthly programs to get people engaged and informed. There are a whole bunch of programs coming up. A full list is located on their website by clicking here or click on image below to register.

"Bouncing Back and Moving Forward" is this week on March 25!

LIFE COACH SESSIONS

YOUR CAN DO COACH

Virtual Group Coaching & Connections.

When we connect with a group of people to give and receive support, amazing things happen.

In these one-hour coaching sessions, you will join a community of people with MS and support partners to build connections, address challenges, and feel more resilient to make life changes.

Register today for Building Resilience to Overcome Setbacks, Tuesday, March 30, 6pm ET by clicking here.

We are looking forward to seeing you and talking about overcoming setbacks! and #takeTHATms!

FDA approves generic for Tecfidera - what this could mean to you.

When a branded drug, such as Tecfidera, loses or outgrows its patent, then a generic may become available. And this may be an expensive change depending on the state you live in.

On August 17, 2020, the FDA approved a generic drug of dimethyl fumarate by maker, Mylan (now part of Viatris), that is biosimilar to Biogin’s branded Tecfidera. This is VERY important to know in certain states such as California because your insurance may no longer cover brand name Tecfidera starting Jan 2021. Or the pharmaceutical company may no longer be able to provide financial assistance. Your doctor may need to change your script before the end of the year.

It’s very important that you talk with your doctor and your insurance company.

Not all states prohibit/limit copay/financial assistance. The generic dimethyl fumarate is made by Mylan with unclear copay assistance. If you want brand-name Tecfidera, ask your doc to write Dispense as Written DAW on script. Pharmacy wouldn’t be able to substitute with generic. Insurance company may or may not cover brand-name med.

Each state is different. Taken from RollCall - News from Congress:

“In Arizona, a new law bans insurers from excluding the discounts only when a brand-name drug lacks a generic alternative, or if the patient obtains permission from his or her insurer to use the branded version.
A 2017 California law prohibits manufacturers from offering coupons at all if a generic is available, but allows copay assistance from independently controlled charities.
A 2012 Massachusetts law prohibits drug manufacturers from offering coupons or other assistance when a generic is available. The generic provision is scheduled to sunset soon, so coupons would be outlawed entirely.
A bill in New Hampshire follows California’s law, and also grants an exemption to patients who obtained their plan’s permission for the branded drug.
A New Jersey bill would outlaw discounts from drug manufacturers but doesn’t mention charities.“

Each state in this country is different but here in California, there is a law (AB265) that prohibits pharmaceutical companies from providing financial assistance for their drugs to their patients once a generic is approved.

I’m not here to form an opinion rather than to inform you that if you live in a state like California and your insurance can not cover Tecfidera or you rely on financial assistance from Biogen, then you could end up with a giant copay surprise. Check with your insurance, state and your neurologist. My neurologist was the one who told me about this and I’m not on it. But this is so important to know!

He mentioned how important It is to talk with these people and make necessary changes prior to the beginning of the year, 2021, as that’s when the insurance coverage will change for this drug.

Talk with your HCP. Talk with your Insurance Company. Call Biogen Support Services ( 1-800-456-2255).

Biogen is available to help with questions ( 1-800-456-2255)

“California prohibits companies from offering copay assistance to patients three months after a generic becomes nationally available. For this reason, starting in mid-November the Biogen Copay Assistance Program will unfortunately no longer be available for TECFIDERA patients who reside in California or obtain their medication from a California pharmacy.

All impacted patients are being contacted to alert them of this change and, if requested by the patient, Biogen Support Services will help them investigate benefit options. Biogen remains committed to providing copay assistance for our other MS therapies, including another fumarate. We recommend patients speak to their healthcare provider to determine what is most appropriate for their situation, or contact Biogen Support Services at 1-800-456-2255.“

Being Thankful During Covid

Unprecedented times, no doubt.

As I review my photos and things that I have done since Covid started, I’m feeling better. A little happier!

First of all, my friends, supporters and family have been amazing during these times. There always seems like someone is just a phone call away, especially when feeling a bit down.

Time to look for things that make me happy. I find myself enjoying paint parties. A great way to build hand-eye coordination, get messy, feel like a kid and have fun. I use the “It’s Just Paint” by Sarah Van Loan. Click here to join one of her many parties planned for the next couple of months! And TRUST me - she makes it so easy. I have never really painted before. These are my firsts:

Cooking, gardening and watching wildlife in my yard were some major highlights these last nine months. The vegetables did great this year. Homemade pickles, lots of sauces and veggies and some beautiful flowers.

This little buck would come over from across the street (the mountains) and join me while I worked and blogged. He’s my little MS activist. My outdoor office desk is about ten feet away from him. It was a nice distraction from the nuisances of MS.

This little lady was across the street and next door. She came down to my patio with her two cubs after I left to run some errands. They had been taking a nap in a tree next door.

In the cooler weather I was able to get some good walks in, 3-miles at times! Most of this came from all the encouragement I received from all my MS friends and supporters. I did get tested for Covid but came up negative. No antibodies either so whatever cold I had before was probably something else.

One place I found a lot of support was via the BELONG.LIFE app, BelongMS. (Click Here to download app). The communities provided, including my support group, Girl with MS, have allowed me to survive during these times. I found myself in a dark hole more than a few times. I reached out and found ways to self-care. I also called my doctor and had my medicine adjusted for anxiety.

I even took out the art pencils and started doodling a bit along with some journaling.

And on the cooler days my legs were able to carry me to the river for some fly fishing. Always one of my favorites.

Because of my walking and yoga... I have been able to keep up with a relatively healthy summer and fall. For that I am very grateful and thankful.

We’ve got this! #takeTHATms!

I know, lots of photos. But they make me happy and remind me of the good times of Covid and not just the stress. Thank you for being there for me!

What's all the buzz about Kesimpta® - the newest FDA approved Drug for Relapsing forms of MS?

OK guys, KUDOS to all those doing incredible research and clinical trials for us living with MS!

Especially during this time of Covid-19, it's nice to hear of the continuous progress being made. As someone living with MS for twenty years now, I am always interested in learning about new therapies and how research and approaches have changed over the years.

Today we have ofatumumab, brand name Kesimpta®, the newest disease modifying therapy approved by the FDA for relapsing forms of MS. Kesimpta® is produced by Novartis. When I heard this, I wanted to learn more!

I’ve been compensated by Novartis in the past but the opinions expressed here are my own

(These thoughts are my own - I am not being compensated for this post.)

Kesimpta® is a disease modifying therapy that targets B-cells in the body to help the immune system manage itself better and help with inflammation. In doing so the rate of relapses and disease progression can be reduced helping people with MS live a fuller life. Or at least this is what the research is showing. I recently wrote about Kesimpta® for Healthline.com and contains a lot more information.

Just released, Kesimpta® is already being prescribed and used. This Girl with MS is darn excited to hear how folks are liking it! You can check out their information and patient support at kesimpta.com.

I sat down the other day and got to interview two interesting folks. One a doctor and one living with MS.

Kerry, 38: Kerry was diagnosed with relapsing remitting multiple sclerosis (RRMS) in 2012 after experiencing a loss of sensation in half of her face for nearly two weeks. Today, she leads a busy life day-to-day as an advertising executive and mother of two young boys. Kerry’s husband is a key point of support at home when MS symptoms may tire her out. Kerry has never taken and is not currently taking Kesimpta. Of note, Kerry currently works for an advertising agency that services Novartis, but is not being paid for this opportunity.

Dr. Robert Shin, Neurologist: Dr. Shin is a Professor of Neurology at Georgetown University in Washington, D.C. and the Director of the Georgetown Multiple Sclerosis and Neuroimmunology Center. Dr. Shin specializes in multiple sclerosis and neuro-ophthalmology. Dr. Shin is a paid spokesperson for Novartis.

I recently wrote about Kesimpta® for Healthline.com. Click here for full article. Some excerpts below:

“This data is very promising and very positive,” Bruce Bebo, PhD, the executive vice president of research at the National Multiple Sclerosis Society, told Healthline last week. “We are excited about this option.”

More than 900 people received ofatumumab in the multi-center clinical trial this summer.

In study results published earlier this month, the immune-modulating drug was shown to quiet inflammatory disease activity.

Researchers said a subcutaneous injection of ofatumumab produced a significant reduction in new inflammation as well as fewer clinical relapses and progression events.

In the second year of treatment, nearly 9 out of 10 study participants on ofatumumab showed no sign of disease activity.

The study covered two double-blind, double-dummy phase 3 trials, ASCLEPIOS I and ASCLEPIOS II. Both were funded by Novartis.

The trials were conducted at 385 sites in 37 countries, comparing ofatumumab with teriflunomide, currently marketed in the United States as Aubagio, by Sanofi Genzyme.

Ofatumumab is similar in action to ocrelizumab, marketed in the United States as Ocrevus by Genentech.

These two drugs were not compared against each other, but the mechanics are the same as they target B cells in an effort to manage the immune system.

“The clinical data is similar between the two, but the route of administration is different,” said Bebo.

I recently wrote about Kesimpta® for Healthline.com. Click here for full article.

You can check out their information and patient support at kesimpta.com.

(These thoughts are my own - I am not being compensated for this post.)

Just earlier this year we had the FDA approval of Zeposia® (ozanimod), produced by Bristol Myers Squibb. Click to read my post about it.

Facebook shuts down theGirlwithMS without warning, specific reason or recourse

On 25 May, 2020, our USA Memorial Day, I received notice that my personal facebook account had been shut down and needed to be verified. After using every tool offered by FB, I was eventually told that I had been verified and would not be verified again. This account was how I access my fb page, Facebook.com/thegirlwithms.

In shutting me down they also shut down my Instagram account. No specific reason. No warning. And no way to contact either facebook or instagram.

At the height of our COVID quarantine, I found myself completely isolated from all of my friends, my family, the thousands of people living with MS who follow me, and all of my MS support groups. As a disabled person, I rely heavily on all social media to help me stay sane and healthy. Maybe that was a mistake.

With all the crud I see on facebook, why in the heck would they take down Girl with MS? I have no way to see who contacts me via my contact button. I can no longer make posts or share important MS studies and tips for thriving with this chronic illness. I didn’t get sent to jail. I got sent to death row.

Thank you Mark Zuckerberg and your algorithms!

Not only did I lose contact with my support group and my MS world, but I lost the ability to continue my MS advocacy via two major platforms, part of which support my finances for living. Maybe fb has gotten too big.

I lost half of my GirlwithMS branding that has been ten years in the making. I’ve lost handles that are no longer available. I’ve lost clients, became in default of contracts, and lost every single memory I have made on facebook and instagram these last 12 years. Every photo is gone. I was wiped off the earth as if in some comic book cleansing.

Here is my facebook page http://facebook.com/thegirlwithms and if you go there and like it and comment to reopen it, the efforts may help!

I have had attorneys interested in covering the case the but the cost was too high. I’m working with an advocacy/lobbying group right now and hope to have some resolve soon.

Here is my last post. I’m glad I had a back up admin to help, but then her privileges were revoked. Was there something wrong with the page? If I did anything wrong than I should be notified and given the chance to correct it.

Is talking positive and sharing tips and research about MS too much for fb to handle? Is this disability discrimination? I have no idea but am waiting for some answers.

It’s time to end the Facebook/Instagram domination and discrimination against those with disabilities.

I don’t have an image of my old Instagram account, TheGirlwithMS. There are others out there but they are not mine. It has been stripped from IG.

I’m just a white face in a gray background. Sounds about right for 2020.

Anyone living with multiple sclerosis or their loved ones will benefit from this page being reopened. Anyone who is tired of Facebook and Instagram’s use of algorithms and lack of customer service will benefit. Everyone who wants justice for the good of the public will benefit.

Facebook and Instagram closed my accounts without warning or recourse. As an award winning blogger and MS advocate, I spend a lot of time, money and energy with Facebook and Instagram. Both of these platforms provide my services as an MS life coach and advocate. They also connect me with friends, community and support groups.

By the way, FB had no problem charging my credit card for ads that were running to promote traffic to my site: GirlwithMS.com, even though I had no access to change the ad or stop running it.

The stress this has brought on as a medically disabled person trying to make a living and stay healthy is over the top. I’ve lost income, thousands of social followers, lost traffic to my blog, lost half of my Girl with MS brand identity and have suffered relapses due to the stress.

Please help my fight this and have our rights restored!

Here is my facebook page http://facebook.com/thegirlwithms and if you go there and like it and comment to reopen it, the efforts may help!

Thank you for your support!

Caroline Craven

Writer | Speaker | MS advocate | Life Coach

You may find me on Twitter @thegirlwithMS.

Hope in the life of the Covid Pandemic - a New MS treatment, Zeposia, approved by the FDA

These last five months have been stressful on the world, let alone those at risk of contracting Covid-19. But in light of it all there have been some shining news that should be recognized in our news today.

The Federal Drug Agency (FDA) has approved another new disease modifying therapy (DMT) for relapsing forms of MS!

ZEPOSIA® (ozanimod), produced by Bristol Myers Squibb was approved and is available for use specifically in the United States. I was able to sit down with Dr. Jacqueline Nicholas, a neurologist and MS expert from Columbus, Ohio, to discuss this new drug and what it means to those living with MS.

Dr. Jacqueline A. Nicholas, MD, MPH, System Chief Neuroimmunology and Multiple Sclerosis, OhioHealth Multiple Sclerosis Center is a board-certified clinical neuroimmunologist specializing in multiple sclerosis (MS) and spasticity.

Dr. Nicholas shares tips and tricks to talking with Doctors and finding the best disease modifying treatment for you:

Over one million people in the U.S. live with multiple sclerosis - or “MS” - an unpredictable and sometimes disabling disease that disrupts the flow of information between the brain and the body. And the prices of DMT’s are reaching new heights. This one actually comes in less than the others, seems like we need to take a closer look.

With 85% of patients initially diagnosed with relapsing forms of MS, ongoing treatment is critical to addressing this devastating neurological disease. Each person can respond differently to MS medications, which is why having treatment options is so important.

Recently, ZEPOSIA® (ozanimod), a new oral therapy, was approved by the U.S. Food and Drug Administration to treat adult patients with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

What will it cost?

The 30-day wholesale acquisition cost (WAC) of ZEPOSIA will be $86,000, which is the lowest of other MS medications in its class.

How does this compare to other DMT’s available on the market today?

·    Based on WAC prices as of March 2020, oral DMT costs on an annual basis for approved RMS treatments are as follows:[i]
o    Mavenclad (variable by weight) $107.5
o    Gilenya (0.5 mg) $103.9
o    Tecfidera (240 mg) $99.3
o    Mayzent (2.0 mg) $92.1
o    Aubagio (14 mg) $92.0
o    Vumerity (231 mg) $86.8

“Bristol Myers Squibb is committed to making ZEPOSIA accessible to appropriate patients who need it.”
o Through the ZEPOSIA 360 Support™, Bristol Myers Squibb will provide a range of services to facilitate access to ZEPOSIA for appropriate patients with MS. This includes a co-pay of as little as $0 for eligible appropriate patients, assistance with financial support, reimbursement for some initial out-of-pocket medical costs – and a program that may help eligible patients with commercial insurance to receive free medication while they are waiting for insurance approvals. Terms, conditions, and eligibility criteria apply. More information is available at ZEPOSIA.com.
o We encourage any families with questions or challenges accessing our medicines to call BMS Access Support at 1-800-861-0048.

There is a lot more information on their website but this is interesting about insurance:

What insurance coverage do you expect?
- We anticipate that 65% of the patients in the US will be commercially insured patients, while the remaining 35% will be government insured patients.
· We have a co-pay assistance program that will cover 100% of out-of-pocket costs for any and all commercially insured patients, which means that around 65% of patients on ZEPOSIA will have a $0 co-pay.

______

It’s important to talk with your doctor and/or MS specialist. Find a treatment that works with you and your goals. There are many options these days!

Time to say #takeTHATms!