Category

Research

We can all participate to make a difference. Occasionally I will get invited to help the community by participating in a study, event, or conference. Whenever I do, I find it heartwarming and energizing to participate.

Janssen #BioExperience Tour

Recently I was lucky enough to be invited to attend a #BioExperience hosted by Janssen Biotech. It was a day of touring the facilities where Remicade is made and an opportunity to speak to the people who develop, create and produce this complex product.

Bright and early we headed on over to the Janssen R & D Spring House Campus, where research and discovery happens. It’s a large stone facility with three flags proudly flying out front. From there we were welcomed to a conference room where the presentation began.  No pictures were taken beyond the room out of respect and privacy for the scientific process and the people who work there.


^^I felt like Charlie going into the Chocolate Factory! So much science ahead. My inner nerd was jumping for joy.

And so our insider’s view into the complexities involved in developing biologic therapies used by millions of patients began. We learned about immunogenicity and interchangeability.  We discussed the steps taken to ensure consistent product and why pharmacovigilance plays an important role. Biologics, biosimilars, new ways of including people into studies that were once excluded, microbiomes and the varied ways genes play a role and the connections Janssen is making in that arena. Janssens’ focus on precision medicine with an emphasis on interception, prevention and cure as the goal. The word cure was actually used and the thought of what that would look like was spelled out. Advocates were asking questions, getting answers, and asking more. We were gathering information, confirming then clarifying, all taking in as much as possible.

^^Dr. Plevy answering questions. We seriously got to ask anything we wanted.
Table meeting image thanks to Tonic_BioExperience. Used with permission.

Next we went on a walking tour to view some of the equipment used in research and development.
Labs right there in front of us with nothing but glass walls as separation. Beside, a whiteboard with hand written positive notes. Literal and figurative messages of hope surrounded us as we viewed scientists growing the field of knowledge before our eyes. I couldn’t help but to be inspired. I wanted to participate, give a sample right there and help by making sure these minds had the materials needed to succeed.

I know science takes time. You have to think about it in the scope of decades versus year by year. But this is happening now. It was a privilege to get a glimpse. It was like peering through a nursery glass at the hope and promise of a newborn.  Instead, it was all my aspirations for a really good treatment and eventually a cure, lined up in an orderly row on a laboratory counter top. I could envision a future where IBD is understood and treated more effectively from the very start.

Our next stop was the Janssen Manufacturing Malvern Campus. We met in a conference room for an informative discussion about the physical process of product formulation and manufacturing. This is where bulk batches are made from cell cultures, ensured of purity and prepared to package for use.

One way the medication is kept contaminate free is the process of gowning. Gowning is a multi step procedure that every employee performs to protect the product that is being made. Because let’s face it, we’re all a bunch of mammals with hair and skin and sneezes. We want to keep all of that out of the treatment that patients will recieve. It is every employees’ priority to keep the medicine pure for patient safety.

Gowning1
^^So let’s go over the steps. First off, what you don’t see is the special shoes worn only in the area where meds are made. Regular shoes are shown here. Next comes a blue jump suit that goes over the foundation layer of scrubs and zips up to the neck. Then rubber gloves, booties over those special shoes, eye goggles and a head net are worn.

Next comes long slip on booties that go up to the knees and fasten with sets of straps to ensure they stay in place.

 

Gowning2
^^Then comes more gloves. By now we’re thinking he is pretty covered. But nope, there’s more.
Next come more feet covers with more ties to keep them in place, a head covering that goes right over the eyebrows and down past the shoulders. After that, a face mask is applied.

Gowning3
^^But that’s not all. Next comes a long white lab coat that snaps from the neck all the way down to half-calf length. Then comes a set of sleeve coverings that go up past the elbows. Finally, another pair of gloves completes the transformation.

Because we were an inquisitive bunch, we asked further questions about this process that you may want
to know:
*The whole procedure is to protect the medication from contamination.
*Employees are checked regularly to ensure they are up to date on safety (including gowning) protocol.
*Employees who are ill stay home. No working sick. (I wish everyone did that.)
*Also, there’s very little talking in the work area. The employees are singularly focused on making sure the product is made without distraction.
*The employees work in 12 hour shifts, much like nurses and other medical professionals.
*Between lunch, breaks and restroom trips, the average employee gowns 6 times per shift.
*The medication never stops process. To ensure continual availability, the lab stays in production 24 hours a day, 7 days a week.
* It takes 90 days from start to finish to complete a batch of Remicade.

Phones and cameras mindfully stowed, we left the conference room to kickoff our tour of the lab areas where growth medium begins and the purification testing process takes place. Dressed in lab coats and goggles we were welcomed into what I lovingly think of as Remicades’ kitchen – But way cooler.  As we walked through a series of rooms filled with shelves and tables laden with equipment, each step was revealed.  The scientists were excited to show us the techniques they use every day. Their enthusiasm was infectious as the process came to life through their examples and narration.

We ended with a video tour that showed aspects of manufacture regular people should probably not be invited to walk through. I appreciated throughout how respectful everyone involved was in regards to each other, the process, the equipment and the medication itself. So an interactive video that walked us through from a first person perspective was more than perfect for the last piece of our visit.

From there we wrapped up our tour with a quick meeting where we got to ask follow up questions and the extended offer to answer any questions we wished to pose in the future.

The day flew by in a swirl of information and discovery. Before I knew it the #BioExperience tour was over. It was educational, hopeful and inspiring. I went in knowing about the topic of biologics but was impressed at the level of thoughtfulness and dedication it takes to make it all come to life. I had moments where I began to imagine a different future for IBD patients. What will this disease-scape look like for my children and how will what we are learning now contribute to that? I was inspired to go home and learn more about what I heard. Several of the topics touched on aspects of conversations I’ve had with my health team and those closest to me. This #BioExperience was perfect fuel for further education. The fact that I got to attend with amazing health advocates was icing on the cake.

**Disclaimers:
1. Janssen Biotech paid for my transportation and accommodations. However, all statements and observations are my own.

2. The image of everyone at the big meeting table was from Tonic_BioExperience. I stated above in caption and in watermark on the image itself and now here. Giving credit is important.

World IBD Day 2015

World IBD Day 2015

A while back I wrote a guest blog called 23andMe – Be a Part of the IBD Genetics Study for The Great Bowel Movement sharing my experiences with the 23andMe DNA test kit.  23andMe is doing a genetic study whose goal is to discover the building blocks that make up IBD so that we may better understand it, and in the end create better treatments and ultimately a cure.

A short time later 23andMe asked to use quotes from the article and images from my blog page. To which I responded with something like: “Go for it!”  Talk about following through.  So on this World IBD Day I was pleasantly surprised with this super cool Ta Da!  The image they created is beautiful.  And a pretty nifty thing for a kid from small town Silverton, Oregon.  I hope it helps boost Ostomate pride, IBD awareness and the ongoing efforts as an entire community to find effective treatments and ultimately cure.

So if you feel like it, go check out the 23andMe page, The Great Bowel Movements page and my article.  Perhaps you’d like to participate as well?

Ostomy Tag Q & A

I was tagged by Megan of Front Butt You Tuber to participate in the Ostomy Tag Q & A. Basically answer 10 questions about being an Ostomate and tag three more Ostomate friends.

So, thank you Megan of Front Butt You Tuber for the nomination. If you want to find her go to: https://www.facebook.com/thefrontbuttyoutuber?fref=ts

In return I nominate:
Christy of Ostomy on the Track https://www.facebook.com/OstomyOnTheTrack?fref=ts

Marisa Lauren Troy of JournalingIBD https://www.facebook.com/JournalingIBD?fref=ts

Stephanie of The Stolen Colon https://www.facebook.com/thestolencolon?fref=ts

The 23andMe Experience

 

23andMe-IBD-study-for-DNA-300x300So a couple weeks ago I was honored to be a guest blogger for The Great Bowel Movement – Awareness for Crohn’s & Colitis where I wrote about my experience participating in the 23andMe IBD DNA study, why it is an important step forward in research for our community, and why we need your help.

I was delighted when TGBM loved my blog enough to post it on their page and delighted all over again when 23andMe liked it enough to share on their media as well.

And so, I will post the article here for anyone who hasn’t seen it and ask that you consider participating.  Because you, my Sweet Bolognas, are important.  You matter with all your uniqueness.  You have all the clues for cure found through struggle and pain, resilience and hope.  You are vital in getting to the bottom of IBD.

With that I give you  23andMe – Be a Part of the IBD Genetics Study

” I am quite similar to many of you, in that I have participated in fund raising, educational events, studies, and testing for a cure. However, this study is a bit different. It’s the idea of looking at the root, versus symptom management and is in line with new DNA based thinking in regards to finding cures for diseases. 23andMe and Pfizer are working to shine a spotlight on IBD and giving us the opportunity as a community to participate in turning the direction of our own disease.

23andme-ibd-dna-study

CCFA Fundraising Through Spin

This past weekend my super cool Gastroenterologist invited me to participate in a spin like Soul Cycle Crohn’s & Colitis Foundation of America fund raiser.

First off I was sold on the description of ‘Party on a Bike’ and something about glow sticks. ‘Scuse me, but glow sticks automatically raise the fun level of any event and ‘party’ equals good music.

All to benefit the CCFA? I love the CCFA!

This whole thing sounded like fun before I even got there.

Heck YES! Count me in.

So after a quick online registration to reserve my spot and prompt RSVP, I Googled what I had gotten myself into.

Indoor Cycling.  Thanks Wikipedia.

Oh yah, I can do this!

My plan was to go and have fun, but pace myself so I didn’t end up falling off the bike in a pile of limp sweaty exhaustion, promptly followed by barfing on the floor.
Reachable goals ~ I can manage that.

The ride itself was held at The Rush Studio in Carmel Valley.  A lovely location with friendly staff not too far from the beach.

I arrived a tad early to a bright, welcoming atmosphere where already jazzed people were visiting, contributing to the donation box and signing up for the raffle. Everyone was excited about the ride, seeing each other and supporting the CCFA. The ladies at the front desk helped me out with paperwork and shoes. In no time I was off to make my own donation, visit and get bedazzled with fancy glow accessories. I can see why people like to come to The Rush. It’s the perfect setting.

After stowing my back pack it was time to grab towels and water bottle then head on in.

As I was a rookie, I chose a spot in the second row next to a gentleman in a white shirt which I was hoping would glimmer under the black lights. Decked out in CCFA orange and blue glow necklace and bracelets, I familiarized myself with the bike and looked around pleased to see the studio mostly full. All cycles faced a mirrored wall where a platform with room for two bikes faced us, front center stage. The lights dimmed as instructor Beth and co instructor Dr. Tommy welcomed everyone with intros and synchronous stretching. And that’s when the atmosphere changed.

It began fast, fun and sweaty. Hey, this is all the awesome of bike riding without exhaust fumes and traffic lights. I’m really digging it. The electrifying playlist chosen by Tommy kept us excited about moving to upbeat rhythms that gave the event a dance club feel. What started out as festive turned into challenging and hot as the microphone amplified voice encouraged ‘Right, Left, Right, Left, Push, Push fast as you can. Harder!’

Momentum increased as the locked in spin shoes allowed for pulling up with one leg as the other pushed against the suggested resistance in a constant circuit of pressing past personal boundaries. Legs burning, tummy tucked in, I worked to coordinate lifting off the saddle in a push up formation against the towel covered handle bars. And then again boosting out of the seat, pumping legs, with one arm raised in the air in upward reaching movements.

Arms and back agreed with buns that spin is a legitimate work out much more comprehensive than the hill hiking I had been doing to make myself think I was fit. I was a fool. This kicks hiking’s ass!

It was easy to get caught up in the wave of determination. The efforts of those around me, the voice of the instructor and the beats of the music; familiar, lyrical words enveloped me in the dimmed room, encouraging to push past the burn and give more of myself. There was grunting and sweat. Pressing up and back so hard the bike rocked on the floor. Warrior sounds from a couple bikes over. This spin thing is no joke! Legs finally got over the initial shock as fire turned to warmth. Then what was beautiful discomfort became a rush of adrenaline and heavenly endorphins. I felt like a candle lit from within. This must be the magic glow that people who love spin talk about.

The pace increased as we moved through a series of stand n’ tap our buns on the saddle, up and down motions that made me aware of a whole different muscle group hiking totally missed. As the spinning slowed pace, we focused on arms. No body part shall be neglected!  As I went through the movements, I reasoned how odd it would look if all these lovely legs, buns, backs and tummies were accompanied by spindly arms and shoulders. Then promptly redoubled efforts to match the work I put into my lower half moments ago.

And then, almost abruptly, the class was over.

We did it! There was an odd sensation of time warp as somehow 45 minutes felt like 15. I high fived the steamy gentleman beside me and twisted my shoe out of the lock to hook my leg over the arm rests for the final blissful class cool down stretch.

We were thanked for our participation and the raffle winner announced. I took my first steps on legs that felt wobbly at first, finding solid ground again with feet that had grown accustomed to pedaling.

Looking around I could see these were not the same fresh participants swagged out in glow necklaces, glasses, and headgear that had started this adventure. We were a mass of smiling, red cheeked, champions.

The Rush Studio CCFA Fundraiser
After the fun. Can you tell we’re glowing?
The Rush Studio CCFA Fundraiser
And with the black lights and glow swag. How fun was this ?!

It was an empowering, affirming, CCFA goal centered team effort. I was so honored to have been a part of it.

And here’s the cool thing about it all. Spin lover or no, this was an example of highlighting your passions and living your happiest in a way that helps others. Dr. Tommy Yen used his love of cycling to support his love for the IBD community. Team Yen raised $300.00 that day for the CCFA, with more financial contributions added later.

Thank you to Dr. Tommy Yen. Way to go with all your awesome!
Instructor Beth Abramowitz of The Rush for leading all the fun.  You are way cooler than Wikipedia said you would be.
To my new IBD friend Ryan Hill. It was so nice to meet you.
And to all the other participants for spinning, contributing, and making the day a great one.

<3 Christy

4th Annual WEGO Health Activist Awards

What the what?!

WEGO health is at it again with their 4th Annual WEGO Health Activist Awards.

“The WEGO Health Activist Awards were created to embody the mission of WEGO Health: to empower Health Activists. We connect with so many inspiring Health Activists who raise awareness, share information, support their communities, and much more – often without recognition. The WEGO Health network is centered around Health Activists, so we knew it was up to us to tell these leaders how great they are! We wanted to celebrate those who have made a difference and thus, the Awards were born. We’ve since found that these Awards are one of the best ways to introduce new Health Activists to the online community and have community members say “thank you” to the leaders they love.”  WEGO Health

Thanks to a very thoughtful nomination, (Thank you !!) I have the privilege of participating for the second year in a row. It really is an honor just to be nominated. If you wanted to endorse me, I would be very grateful.

There are other really amazing and inspiring IBD advocates who pride themselves on giving accurate information and boosting hope in the running as well. It would be wonderful if someone from the IBD community took the 2014 win. Don’t you think?

Sara of Inflamed & Untamed – Crohn’s/Colitis Support

Frank of The Crohn’s Colitis Effect

Eric of Vegan Ostomy

Colitis Ninja

And me, Christy of Crohnie Bologna IBD

Christy of Crohnie Bologna IBD
Christy of Crohnie Bologna IBD.

How fun is this?!  My life is filled with surprises.  This happens to be a very delightful one.

April is Autism Awareness Month

April is Autism Awareness Month.  In our home, Autism Awareness happens every day.  So for the last day of April I share with you this tiny peek into how that initial discovery worked out for us.  What we are doing now.  How those efforts are panning out, and what we are still working on.  

Shine a light on Autism.  


An Autism Diagnosis is either a confirmation of a suspicion, or it’s an exposure of a truth most parents saw, but were characterizing as other behavioral needs. 


After diagnosis there is a sense of loss and grief.  The idea that your child is just going through a rough patch and will overcome this in a matter of months is over.  What caused this?  Is there a genetic component?  Is it environmental?  Is it diet?  Is there anything more I can do to make this better?   The questions build from there.  The reach to understand what caused this thing is all consuming. 

No one goes into parenthood planning for their child to struggle.  No parent signs up for the laundry list of worry.  Will he grow up and be an independent adult who goes to college, has a career that makes him happy, and will pay his bills? Will he have the social skills to find a loving spouse and someday make beautiful children that he can nurture?   By then will he have gained the know-how to keep it all together?  The dreams you automatically assume for your child at birth are replaced with questions. 

Then there is the question of how to move forward.  Here is what we did:
We suspected from early on that something wasn’t quite right.  Our son screamed a lot, wouldn’t sleep, was verbally behind and socially outmatched by his peers.  For a while we wondered if he had a hearing problem and got him tested.  The older he got, the further he fell socially behind his friends, even the ones much younger than him.   In addition, we experienced delays in speech, social quirks such as lack of eye contact or inability to intuit others emotions.  Compulsive things like shutting all doors, lining things up, and toys that only work ‘just so’.  He experiences other manifestations like hand flapping, rocking, spinning, and head butting.  In addition, we observed a limited diet stemming from an inability to tolerate sensation of certain foods.  He quite often becomes overwhelmed by self care tasks such as dressing, potty, washing body, hands, and or face, and brushing teeth.  He would cry from tummy aches and have digestive difficulties and even accidents.  We also help him cope with emotional outbursts of aggression and an inability to self regulate.  If everyone else is play fighting like a ninja, he is really fighting and hitting like a ninja.  If kids are running and screaming, then stop; he has a hard time turning it off, and will often just continue screaming until we help him stop.

It was beyond obvious that something was seriously wrong when we began to tailor our life around what we felt our boy could tolerate.  We believed our doctors suggestion to not worry until he was three years old.  We ignored that inner nagging truth that something wasn’t quite right.  We had allowed ourselves to be assuaged by the kind words of friends and family for too long.  No one observes your child and tells you, ‘Girl, you need to get your boy some serious help.’  Instead we got plenty of, ‘My son does that too.’  or ‘It’s hard being three.’  Kind words from good, gentle people.   It became clear once we realized our family had been avoiding functions and outings.  We even prepared for ‘quick exits’ when we did venture out.  We stopped eating at restaurants.  The pattern we had begun to live was not normal or sustaining.  We took our son to the doctor again. 

We were assured that all boys are slow to talk; he will speak when he has something to say.  You should spank him as we have not provided good enough discipline.  We’ve spoiled and over indulged him.  You are comparing him to older siblings- it is not helpful to compare children.  In the end, it was suggested that our son may have Oppositional Defiant Disorder. 

At that point we asked for a referral to the local children’s hospital to have him tested.  We did not believe that he was oppositional defiant, but something else was going on.  The waiting list was eight plus months for an appointment, and a year before he would get a full exam.  That was too long a wait for us as we felt we had already spent so much time going in the wrong direction.  We took our son to the local special needs branch of our school system which does a comprehensive screening of social, speech, cognitive, fine and gross motor skills, and hearing tests.  Our boy was classified as Autism Spectrum and we were offered resources.  However, we were also in the middle of a move to another state and could not accept services or the IEP that was offered.  Knowing what I know now, and looking back on that decision, I should have gotten the IEP before leaving the state. 


We told family and friends about our sons diagnosis as we needed to be surrounded in support and understanding.  It immediately made a difference in how he was treated by some family members, who until then, were working under the assumption that our son was an oversensitive hand full who refused to sit still.  Our son has been treated with care and compassion from that time on. 
From there I began to read.  I stayed up late every night staring at my computer, taking notes, comparing research, diet, varying cultures approach, opening my mind and widening my heart to Autism.  I learned from those that went before me, and actively applied knowledge I felt confident I could fully implement correctly to achieve the desired results.


The main change we made was to switch to what is known as the ‘Autism Diet’.  It is best described as Gluten Free, Casein Free.  Gluten is the protein composite in foods processed from wheat.  It gives breads rise and texture.  Gluten is also found in soaps, lotions, and as filler in foods such as lunch meat.  Casein is the protein in mammal milk.  It is a main ingredient in cheese and is a food additive. 

Each family begins this diet differently.  I only wanted to eliminate those things that were a deficit to our son.  I began with removing the Dairy and Casein.  Basically because I knew the code words for it and felt I could do that successfully.  We quickly saw improvement; less spinning and screaming.  One Saturday morning my husband and I were sitting in our kitchen enjoying each other over coffee.  He looked over at me and asked, “Do you hear that?”  I look around; trying to catch what he was referring to.  “No, what are you talking about?”  He nods his head towards our son quietly playing.  “It’s quiet.  He’s not screaming.”  We knew from that moment on that we were never going back to dairy.  Hope grew that day. 


Emboldened by our successful results, we removed Gluten.  Our son began to sleep better and we started to get more words versus grunting, pointing and melt down.  Over time he started to have more speech that we could easily understand.  We could now brush his teeth and wash his face.  He became potty trained during the day.  He began to eat foods he never tried before.  He could ask for what he wanted.  He began to sing and hum on his own.  One evening he crawled in bed for cuddles.  He noticed the sparkles on our bedroom ceiling and began to sing ‘Twinkle Twinkle Little Star’ in his sweet little voice.  I know I had sung that song to him a hundred times; not really knowing if he was taking it all in.  And here he was singing it to me.  I gazed over at this wonderful boy in my arms memorizing his features as he formed the words, eyes dancing over the sparkles up above us.  I could feel my heart fill with love, joy and gratefulness.  In the middle of my mommy moment he looked over to me and said, “C’mon Mama, sing!” And so we did.

He still had horrid rashes.  Red, raised dry patches that would bother him, they were weepy and would smell as he would not tolerate medical tape to apply a covering.  He would itch all over and cry.  So after reading, we cut out soy as well.  His rashes are better and he only gets them when he inadvertently eats something he shouldn’t. 

Our new doctor suggested we avoid food dye for our lil’ guy as she had read a study showing benefit.    We eagerly followed through, welcome to have a doctor validating, versus telling us we were nuts for trying.  Our doctor also fully agrees with our use of the Autism Diet and has commented on the improvements in our son over time with her exams during his well care visits.

In total we are Gluten Free, Dairy/Casein Free, Soy Free, and Food Dye Free- particularly red dye. 

I have always been that mom who is nutritionally aware and made most of the snacks my children ate.  Baking Gluten Free is quite similar to what I was doing before.  Just different ingredients headed towards the same delicious end goal.  I bake our bread, muffins, cookies, cakes, pies, pizza dough and every other yummy thing any kid would love to eat.  I make his cheese and am a militant label reader.

Our pantry went through a much needed overhaul.  Convenience items such as Goldfish crackers, wheat thins, and most every store bought cookie, pretzel or pastry had to go.  It also meant giving up pre packaged foods in general.  Standard macaroni and cheese, pre packaged soups, sauces, and pasta all found a scrumptious yet safe replacement.   We now enjoy beautiful, delicious food made of unprocessed, basic ingredients without those between meal crackers or crisps. 

We still have more work to do.  Now I am restarting the process of getting our son evaluated in our new state to get an IEP in place so he can get the various therapies on board.  I am still working on his sense of danger, i.e. He has none, so darting into the street is a common thing we are trying to help him with.  We are helping him with transition away from his routine.  He is learning patience, calming techniques, quiet voice, social skills, (most of our time is spent on social skills) and more. 

But we have gained so much.  Because of the Autism Diet he has gone from a frustrated, confused, screaming little person to a boy who can communicate, count, sing, draw a picture, and be happy.  He has come so far and will continue to improve.   


There is no quick fix or stepping in to save the day.  It is the every day, all day, work, patience, diet, guidance and energy put out by dedicated parents that gets the job done.
The effort and satisfaction in implementing the Autism Diet feels like a rescue mission for my child’s future. No surrender and no giving up until he can be successful on his own.