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Guest Post: Patient Voices Matter

I’m grateful the National ALS Association gave me a platform to be heard.

The Official Blog of The ALS Association

This guest post is from Shelly Hoover, EdD, a member of the Patient & Caregiver Advisory Committee, and does not necessarily reflect the opinions of the Association staff, its Board of Trustees, or its chapters.

By guest blogger Shelly Hoover

Patient voices matter, yet the collective ALS patient community has been too patient and too quiet for too long.

The ALS Association led an unprecedented effort to develop an FDA Guidance Document for Industry. Here’s a quote from the introduction:

“In February of 2015, The ALS Association launched this effort to develop the first-ever community-driven drug development guidance for ALS with funding from the ALS Ice Bucket Challenge, bringing together over 100 participants including people living with ALS, caregivers, researchers, clinicians, and industry experts from across the world to contribute their expertise and experience. In parallel with this effort, a committee was formed to update the ALS clinical trial…

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Get On Board or Get Out of My Way

I’m done playing nice.
I’m supposed to be dead.

This is an urgent call to action. Keep reading.
I need your help! 

With an ALS diagnosis in 2013, I was given 2-5 years. I’m alive but being protected to death by the FDA, and I’m not alone. Every 90 minutes someone is diagnosed with ALS and every 90 minutes someone dies from ALS.

The 2014 Ice Bucket Challenge raised over 100 million dollars for research. Today, promising treatments are sitting in the FDA pipeline. It takes decades and billions of dollars to get an effective treatment approved.

We’ve played nice and we’ve been ignored.

Two years ago, the National ALS Association (ALSA) wrote an FDA Guidance Document that is being lauded as the gold standard of industry guidance. Half of the 14 patients on the guidance committee died waiting for public comments. The FDA just released Its version of ALS Industry Guidance. I, the remaining committee members, and thousands of others will die waiting because the guidance does very little to advance treatments through the lengthy and costly approval process.

The voice, concerns, and suggestions of patients and our allies were largely ignored in the original guidance and our Call to Action was buried in the very last pages of a 139 page document. We had high hopes that the efforts of so many would dramatically impact drug trial design and approval process. Our lives depend on it. Nope. The new and exciting guidance from the FDA Includes: patients with ALS are willing to take greater risks because the condition is terminal. Thank you, Captain Obvious.

I’m waiting to test the California Right to Try law or use the FDA’s Expanded Access Program when a new drug I’ve been following passes Phase 1 safety and tolerability studies. There is no requirement for the company to give me the drug, only a moral imperative. I gladly spent a total of six weeks in the hospital and dozens of appointments in San Francisco. I have great hope that this new molecule will dramatically slow my progression or stop it all together. The trial is still in Phase 1 two years later. Waiting those two years cost me the functional use of my hands and arms, it cost other people their lives.

We are not asking for a safe and effective treatment for erectile dysfunction. We are demanding access to potential life-saving treatments that are stuck in a 15 year, billion dollar approval process. Answering FAQs and minor tweaking don’t come close to the paradigm shift required to save lives today. Stem cell therapies and promising treatments exist but are not accessible.

ACT UP seized the FDA 30 years ago with the same obstacles facing people with HIV/AIDS. It’s time for us to do the same. Most with ALS can’t march or yell because many are paralyzed and can’t speak. But we have assistive technology and 400 pound wheelchairs. Get on board or get out of our way.

Urgent Call to Action

  1. Immediate access to promising treatments that have passed safety studies.
  2. No placebos in clinical trials, use historical controls instead.

Stop protecting us to death. The cost of a military parade could provide life saving treatments to every American living with ALS. US veterans like me are twice as likely to have ALS. It’s time for the US Government to cut through the regulatory red tape of the FDA and provide life-saving treatments now.

What’s Next?

The patient community has the right and responsibility to get loud and demand our voices be heard. We need 1,000 public comments to get the FDA’s attention. You can help by leaving a public comment of your own. Click here.

Tell your story and demand access to treatments and radical changes in how ALS drug trials are designed now! Status Quo = Death.

It’s easy to comment. Here’s how:

  1. Click here to go to the public comment website.
  2. Type your comment. Note: It’s best if you write your own comment, but here are some suggestions on what to include:
    1. Your relationship to ALS (patient, loved one, friend, etc)
    2. A statement about how this guidance document is unacceptable. For example: The proposed guidance document doesn’t adequately address the urgent needs of patients who have a terminal illness – especially an illness without an effective treatment. It is cruel to withhold access to treatments that have been proven safe and show promise, but are stuck in a 15 year, billion dollar approval process. It is time for the FDA to stop protecting ALS patients to death. ALS patients need immediate access to promising treatments that have passed safety studies. ALS clinical trials should NOT require placebos and use historical controls instead.
  3. DO NOT put your name and contact information in the comment as it will become part of the public record. There will be a place later in the process to put this information. It is optional and will not become part of the public record.
  4. Uncheck the checkbox that says: I am submitting on behalf of a third party.
  5. From the drop-down category menu, choose: Individual Consumer
  6. Your comments won’t post until they have been reviewed by the FDA, so don’t be surprised if you see zero comments posted.

Make your public comment and share this far and wide. Thank you.

If you’re having trouble submitting a comment on the above link, try here and click the green button. Note that the 270 comments listed refer to a previous document from 2013.

If our voices are dismissed again, we will show up at their door demand action. Imagine 250 power wheelchairs at the FDA headquarters. Here’s how ACT UP did it 30 years ago.

***

Learn more about ALS

Checking In

Unpublished blog posts sit abandoned in my draft folder. One is bitter;  Another begs victim hood. That is not what I want to put out into the universe. So here I sit, gazing at my keyboard, trying again. I’ll just give it to you straight.

Physically
The functional use of my arms is gone. That means I can still use my arms to knock things off the counter, but that’s about it. If we meet for lunch, you’ll have to feed me. Don’t worry about the mess. I’ll have a color coordinated bib, with a convenient Velcro closure,  neatly stowed in my pee bag.

The real bummer is that my progression has reached my mouth and throat. The changes aren’t noticeable unless you live with me. But the signs are unmistakable — excess saliva, choking on air, hoarse, reduced voice volume, muscle spasms in my throat and neck. And when I’m tired, I sound like #45 with dry mouth, “God bless the unitshed shates of amershith.” I have an appointment at the multidisciplinary ALS clinic next week and will meet with the speech the pulmonary therapists. I had been hoping for an effective treatment before I reached this point, but it is not meant to be.

Emotionally 
I’ve been struggling.  My emotional bandwidth isn’t there as I’ve switched from waterproof mascara to no mascara at all. Two local friends with ALS died this week. Tammy was the second woman I’d met with ALS. I was drawn to her gentle spirit, strength, and endless optimism. JT had unmatched charisma and charm, and a wicked sense of humor. Both were deeply loved by family and friends. Coping with my own loss and sadness for Tammy’s and JT’s families is overwhelming.

Spiritually 
I’m at peace with my maker yet miss being part of a faith community. I’ll add this to my New Year to do list.

Return to Gratitude
There’s a time to grieve and a time to live. I do both with profound gratitude and peace in my bones.

What are you grateful for today?

I’m Forgiven and Free and grateful I get to try a recently approved medication that may slow my progression!

radicavapic

The Little Things 


It felt like God gave me a gentle kiss on the forehead.

This morning I was waiting for the ALS Advocacy conference to begin and in walked Chrissie, my sister from another mister. We embraced for a moment longer than last year as we silently acknowledged that Karen wasn’t with us

Then Chrissie exclaims, “I have something for you!” and hands me a tiny pillow. “This was Karen’s and I want you to have it.” 


Karen found comfort by resting her motionless hands on this soft pillow that Chrissie made for her. I took one look at the pillow and knew God  was in this. 


The anchor on the pillow is identical to the anchor on my recent foot tattoo. Coincidence? I don’t think so. 

I knew seeing my Delaney sisters for the first time since Karen’s passing was going to bring a host of emotions. What I wasn’t expecting was God showing up in something so little, yet so huge. 

God shows up in the little things to bring us comfort and peace. Be on the look out for the big gifts that Show up in small packages. 

I’m Forgiven and Free and thanking God for the little things

Preparing for Life without Hands

Legs are relatively easy to replace with equipment and ramps. I use a power chair, shower chair, patient lift, lateral rotation bed, and a van with a ramp and hand controls.  Once I’m showered, dressed and lifted into Ruby Tuesday (my power chair) I have a semblance of independence.  I can drive short distances, go to the store, go for a roll, or meet a friend for lunch.  This is relatively doable and has been my life for more than three years.

Life without working arms and hands is going to be a bit more complicated. My ALS progression has remained relatively slow. Yet, I’ve reached a point where I’m losing important function in my arms and hands.

Imagine an elastic band wrapped around your chest holding your arms at your sides.  Now try to move your elbows away from your body.  At the same time, a strong person is pushing down on your shoulders. Now pretend you’re eating a bowl of cereal and the same strong person is pushing your hand down while you are trying to reach your mouth. This is what it feels like to move my arms and hands.  So simple tasks like putting a jacket on and off or brushing my hair are difficult, if not impossible, and physically exhausting. I’ve limited my driving to only a few miles during the day.  I haven’t had any close calls while driving but I’m being proactive and not taking a chance of having an accident caused by fatigue.

I watch my 2 year old grandson gradually master the use of his hands.  As an infant he would try to grasp a toy or reflexively grab my finger.  Then he could pick up a Cheerio and find his mouth.  Now he can manipulate puzzle pieces and draw circles with a crayon. As my hands atrophy and lose function, we are traveling the same path in opposite directions.  We will meet soon on the continuum.

Tasks requiring fine motor skills are eluding me. I can’t open a shampoo bottle or squeeze a tube of toothpaste.  Eating in public is quite embarrassing as I eat like a toddler hoping the finger food makes it into my mouth on the first attempt. Last night I tried to put a handful of vitamins and meds into my mouth, like I do every night, and completely missed.  Not one pill made it to my mouth. So I tried again successfully with a two-handed approach.

Like the equipment that replaces my legs, I have some new technology that will replace my hands.  Meet Tobii.

tobii

Tobii is a speech generating device that can be controlled with my eyes. The bar below the screen has a camera that follows the reflection of light from my retinas.  So my eyes move the cursor like a mouse. I can navigate in the apps provided, make a phone call, use any Microsoft program, or access the world wide web.  Pretty amazing.

Tobii joined the family a few weeks ago.  There’s quite a learning curve to achieve proficiency and I want to make that happen before I’m completely dependent upon it.  For now I can still type with my shaking fingers, but my days of typing over 100 wpm are long gone. So I practice typing with my eyes in the evening when my hands need to rest.

Meet Obi.

obi

I met Obi the robotic feeding arm last week.  We practiced by eating Cheerios and it was love at first bite. My occupational therapist is helping me make Obi a permanent part of the family. She is also working on a voice-activated control for my bed so I can operate the 13 functions without using the remote. I’m forever grateful to the VA healthcare system that generously provides all my technology and equipment. Thanks to the VA, I am able to live the healthiest, safest, most engaged and independent life possible.  Many people with ALS rely on medicare and do not have access to this life-giving technology.

The past few months have been emotionally difficult as I process the grief of my diminishing independence. Spontaneous tears. Racing thoughts bounce in my head:

  • I don’t want to live anymore
  • I can do this with the love and support of my husband, family, and friends
  • I want to quit everything and hide
  • I can stay engaged in teaching and writing
  • I’m a burden to my husband and children
  • How will I cope with total paralysis?

Then I noticed that my thoughts are all about me and this self-focus is not emotionally healthy.  It’s time to return to gratitude, be present, and engage at whatever level I can at the moment.

I’m Forgiven and Free and grateful for my family and technology

 

Balance: Mind, Body & Spirit

I practice in my Christian tradition that:

  • my mind is to be fixed on praiseworthy things
    Finally, my brothers and sisters, always think about what is true. Think about what is noble, right and pure. Think about what is lovely and worthy of respect. If anything is excellent or worthy of praise, think about those kind of things. – Philippians 4:8

  • my body is a temple of the Holy Spirit
    Don’t you know that your bodies are temples of the Holy Spirit? – 1 Corinthians 6:19
  • the Spirit of God dwells within me
    The Spirit is in you, and you have received the Spirit from God. – 1 Corinthians 6:19

I find these teachings helpful and true for me. Holding these Bible verses in my heart brings me peace and purpose. Yet, as my ALS progression renders more of my body useless, I’m perplexed as to how my failing body is worthy to be a temple of God.

I view my mind, body, and spirit as separate entities and struggle to keep balance because I’m not able to tap into my mind and spirit to bolster my failing body.

Something was missing in my understanding. I was missing the inseparable and interdependent relationship of the three. Coincidently (well maybe it’s not a coincidence), I’ve been studying the Eastern Cherokee people of North Carolina for a work of fiction. The Cherokee people believe that one must strive to maintain social and spiritual harmony and balance. Internal harmony and balance allows individuals to be at peace with their bodies, their thoughts, their emotions.

Looking at my life through the Cherokee lens was the subtle shift I needed to bring my mind, body, and spirit back into balance. Can I find balance amongst my mind, body, and spirit with my body being a hot mess of dying motor neurons? I think, yes.

There are eleven major systems in the human body. Just one of mine, the nervous system, is failing and ten other systems are going strong. I can focus my thoughts on all the systems in my body that are doing well and speak health into my body by integrating my mind and body.

My spirit? The Holy Spirit dwelling in me? I’ve got some work to do here.

I’m Forgiven and Free and working on integrating the three.

 

 

Resolutions with a Twist

Oh, there is much I want to do in 2017.

Find a cure for ALS.
Advocate for social justice.
Travel to Europe.
Walk.
Write a book.

There is much to do, but I’m not resolving to DO anything.

My new year resolutions are about the person I want to BE.

I resolve to be:
Loving
Joyful
Peaceful
Patient
Kind
Gentle
Faithful
Grateful

I figure if I focus on the person I want to BE, rather than what I want to DO, what I do accomplish in the coming year will be exactly what needs to be done.

Truth is, I’m often scared about what the future will bring while living with ALS. What function am I going to lose this month? Is this the year my physical function goes completely to hell? Will life be worth living? What if, what if? I’ve not found it productive to dwell on such things.

What I do know about the coming year is regardless of what ALS does to my body, I will continue to be loved and supported by family and friends. I will spend my energy being grateful and searching for silver linings.

I’m Forgiven and Free and focusing on the person I want to BE

My Shrinking World

Some is my own doing; some is a consequence of declining mobility and function. But no doubt, my world is shrinking. My constant go, go, go has been reduced to a single go and rest the remainder of the day. Friendships have diminished; some have extinguished.

Much of my time is consumed with medical appointments, researching and trying out the technology that is slowly replacing my own functionality. This week it’s a bed that rotates my entire body from left to right. Ahhh. I’m so excited at the thought of being able to move again in bed! An able-bodied person moves every 11 minutes during sleep. I move a total of zero times if unaided by a rotating bed or tired husband.

Eye-gaze and speech to text technology will soon replace my failing hands. It’s a good news bad news thing. The bad news is my hands are failing, the good news is there is technology available to replace clicking and typing with my hands. Thanks VA Healthcare for providing all the technology I need without putting up much of a fight.

ALS can be physically isolating. I miss full-on hugs. They’ve been replaced by awkward side arm hugs from my power chair. I miss easily visiting a friend’s house. Steps and door thresholds are not friendly to me. Sure ramps can typically get me in the door, but then there are those pesky rugs and tight corners. I would hate to take a chunk out of your drywall.

ALS can be socially isolating as well. Eating is now a difficult and messy proposition and many social interactions revolve around food and drink. I’m sure I’ll get used to the stares and mess. But for now it’s still embarrassing.  I’m transitioning from a social butterfly extrovert to a peaceful introvert. I’m growing more comfortable with extended periods alone with my thoughts. This isn’t necessarily a bad thing. It is what it is.

Is my shrinking world a function of age? Disability? Wisdom? Isolation? Self-pity? I’m not sure. Oh wow. This is sounding like a pity party that needs to end. Let’s focus on gratitude. I’ve got a lot to look forward to and even more for which to be thankful.

I hope to be participating in the next arm of the GDC-0134 phase I clinical trial slated for January. If all goes as planned, I will be taking the new drug every day for two months. Hope is exciting stuff.

I’m Forgiven and Free

Right to Die

I don’t want to die. If fact, I’m fighting to live!

The End of Life Option Act just became law in California. A patient with six months to live has the option the obtain life-ending medication. Here’s the problem — the medications have to be self administered. By the time most ALS patients have six months to live they are completely paralyzed and do not have access to the End of Life Option. Many are also unable to communicate and can’t make the two verbal requests and one written request required by the law.

I was interviewed by our local CBS news affiliate last week and shared how people with ALS and other physically debilitating diseases won’t be able to access the law. Regardless of how you feel about it, it is the law and everyone should have access to it regardless of a disability.

Looks like we have some advocacy work to do. Speaking of accessibility and advocacy, why do all forms of public transportation have wheelchair accessibility except airplanes? Anyone know how to make that happen? Do I have to sue the airlines?

I’m Forgiven and Free and looking for accessibility

P.S. Here’s a link to the video: CBS Local News Segment

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