THE BESTFIT PROTOCOL COURTESY OF TONIX PHARMECEUTICALS

It was a surprise.

And it was better than I expected.

I got approached by a woman named Laura Colontrelle-Radocaj of Dian Griesel, Int'l. She asked if I'd be open speaking with Dr. Lederman who is the CEO of Tonix Pharmaceuticals. I was aware of the clinical trial that was taking place and had written about it previously so I was thrilled that I had been given this opportunity.

I believe there are subgroups of Fibromyalgia. I also think that is why Lyrica, Savella and Cymbalta (which are all FDA approved treatment for Fibromyalgia) don't work for everyone. For me, Lyrica was worse than the Fibromyalgia. I gained weight, death for me, and my thoughts went to a very dark place. I can't take it. There aren't a lot medications out there that are approved so something new on the horizon was good news. When I heard about the clinical trial, I was hoping I could be a part of it. 

What is it? 

In a nutshell Tonix Pharmaceuticals is using cyclobenzaprine in new doses and formulations for treatment of Fibromyalgia and Post-Traumatic-Stress Disorder (PTSD) which are chronic central nervous system disorders.

So what did I do?
I missed the first call.

In my defense, we didn't make it clear what time zone we were using. So after apologizing over and over again we finally settled on 9:00 Las Vegas time. I felt like SUCH an idiot but it worked out and the call came.

What a wonderful conversation! I expected a few moments. After all, this man is extremely busy so when he kept answering questions and offering information I was floored. We actually spoke for 45 minutes. 

At first I wondered why Fibromyalgia and PTSD? To me, they were on opposite ends of the spectrum until Dr. Lederman gently reminded me how many cases of Fibromyalgia start with trauma. 

Mine included.

I found it interesting that these two disorders could be related. PTSD, however, deals with the trauma and the lack of sleep in nightmares. Fibromyalgia has non-refreshing sleep but the trauma doesn't usually have the nightmare outlet. 

Another thing I found interesting was when I asked him about alpha wave intrusion. The new term for alpha waves is cyclic alternating pattern (CAP), type A2 and type A3. It seems that we all have alpha waves but with Fibromyalgia we have too many alpha waves and they are too frequent. This is what interrupts our sleep. 

I also asked about the use of Flexeril. Cyclobenzaprine (Flexeril) is an FDA approved drug that treats the muscle spasms that is associated with musculoskeletal conditions. Pain managers use it quite frequently but it's difficult to take because it makes you groggy and sleepy the next day. Well, it seems that it takes two hours  to get into the bloodstream so if you take it before you go to bed it won't take effect for two hours. No wonder people are groggy in the morning! 

The BESTFIT protocol (BEdtime, Sublingual, TNX102SL, as Fibromyalgia Intervention Therapy.) uses a very low dose cyclobenzaprine. The great part of using it sublingually is that it enters and leaves the bloodstream quickly.  This trial is a 12 week, randomized, double blind study. 

This study has approximately 120 patients taking either a tab or placebo at bedtime for twelve weeks and then measuring the change in pain intensity. The trial is fully enrolled and will report the top line results early in the 4th quarter. It will measure reduction of pain, fatigue and mood. The study chair for this trial is Dr. Daniel Clauw, Professor of Anesthesiology, Medicine and Psychiatry and Director of the Chronic Pain and Fatigue Research Center at the University of Michigan. 

We're about 100 days out from finding out what has come out of the trial.

To me, it can't come soon enough. 

I have to mention one other thing about Dr. Lederman. He was a rheumatolgist and had a practice.

Then, in his words, committed "professional suicide" by going into Fibromyalgia research.

How many people would leave a thriving practice to research Fibromyalgia? 

And this man is passionate about helping those with CNS (central nervous system) disorders. 

After speaking with him?

I was more than impressed. 

He listens. Really, really listens.

All I can say.........

His patients must REALLY miss him.

IS IT HOT ENOUGH FOR YOU?

110 degrees.

Under the eaves.

In the shade.

I've never liked the heat and I like it even less now. You'd think that after 51 years in Las Vegas that I would get used to the desert heat.

Not only no.
Hell no.

I didn't mind it as much when I was in the pool but with the onset of age and some common sense, I stopped baking in the sun. Then, when I was working, I spent a great deal of the day in the sales office. I only ventured outside when I couldn't talk anyone into not looking at their home site in the middle of the day. 

Now I just stay inside.

Since the thyroid regulates temperature is it still a by-product of the autoimmune issues I have with it? I take enough thyroid medication to keep it in the "normal" range but maybe it isn't enough. I just can't seem to deal with the heat anymore. I think heat intolerance doesn't adequately describe it.

It makes me sick.
The upside? I can use the Vitamin D.
Did you catch the sarcasm dripping off of that last statement?

We're going to have excessive heat this week. I wasn't kidding about the 110 degrees. The official heat is measured at our airport about 30 feet up and under the eave in the shade. Really. In all actuality it will probably be 117 in the lower parts of the valley. This kind of heat is smothering. The temperature in the car can easily get to 140. You don't mess around with those kind of temperatures.

It gets dangerous.
No kidding.

You have to plan any errands in the "cooler" part of the day. That means before 10 in the morning and after 7 at night. Even then I take a cooler with me to the store because a quick trip can mean frozen food can start to thaw. Sunglasses are a must if you have light sensitivity (which I do). 

And you have to stay hydrated.
Again, no kidding.

So I'm hibernating this week and praying that the heat will break, otherwise, it's going to be a doozy of a summer. That doesn't take into account the amount of money I'll be donating to Nevada Power.

Gee, I can't wait.

So here I am wishing I was in Antarctica.

But.......hey........

it's a dry heat!

So I think I'll watch the fireworks on TV.......

UPDATE: the clouds moved in and it now has started to rain. Yay for the ground, bad for me.

CAN I EVEN REMEMBER MY OWN NAME?

I am truly Miss Erable. 

Not only am I in pain.

But my brains are fried.

I had the greatest start. I got a call from Tonix Pharmecuticals and spoke for about 45 minutes with Dr. Seth Lederman. He's the CEO of Tonix and it was absolutely an amazing phone call. 

More on that in the next post.

Then, I realized my real estate license requires education within the two year of the four year period. Now, that means I have to sit in class for 3 hours..... and I need to do this for a total of twelve hours.

First of all, I hate sitting in classes. It hurts because the chairs are hard and by the time I get up I can't walk. The pain is shooting down my legs and I'm crying because I'm only a quarter of the way done.

Oh my.

But I've come to a decision. 

I'm making an appointment with a neurosurgeon. I always said that when I could no longer sit or stand without pain I'd give in and do something about my back. I can handle the Fibromyalgia pain but the back pain is beyond handling anymore. So I'm making the appointment to see what needs to be done. Years ago the odds were not that good that they could repair my back and have the outcome favorable. 

Hopefully, things have changed.

So between the back and the real estate classes I haven't had the time or the motivation to write about the wonderful research that Tonix Pharmaceuticals has done.

And it could be a game changer.

So off to more torture tomorrow.

Did I mention that I also missed the cutoff for my classes?

That's a lovely little $100 fine.

Great......

THE YUCK FACTOR

Well,

it seems like it's back to the drawing board.

Let's hope this works.

I'm really sick of going to doctors. I guess what I mean to say is that I'm sick of feeling so lousy that I have no choice but to go to the doctor. I have to say one thing. I do have a great doctor. He's very curious and he believes me when I tell him that I feel lousy. This, however, means going for more blood tests.

Do I have any blood left?

After 17 vials...........

Evidently, my thyroid is still borderline. 

The autoimmune thyroiditis is in full force.

Everything else? Right on target.

However, they found a nodule in my thyroid. So now I have to go through another ultrasound and then if it's growing there's another fun test. A biopsy. If that happens I think I'd actually be relieved. At least then I'd know why I feel the way I do. 

The problem is the symptoms are so intertwined.

I don't know if it's the thyroid or the Fibromyalgia. 

The fatigue is overpowering. I won't even count the pain because that is always with me. It's just that my hands have hurt more than usual. I don't think its the Fibro because I just feel so..........

Different.

I gave in and went to the endocrinologist. More blood work and I'm back on the Armour Thyroid. I did feel better on this when it was prescribed to me a year ago. Hopefully this will pull me out of the constant feeling of yuck. Why they felt the need to change it is beyond me. 

The symptoms of hypothyroid and Fibromyalgia are SO close. How do I know this isn't Fibromyalgia? For one thing.....my hair. It's very dry and thinning out. The doctor said the Cytomel will do that. Why in the heck did they ever prescribe it? I know it's more precise than Armour Thyroid but it can't be that big of a difference. The other thing is that my skin is much drier. 

Try peeling off the tips of my fingertips. 

The scary thing is that no amount of lotion or cream would stop it. I even got steroid shots but that didn't work either. The only thing the shot seemed to do is make me gain 5 lbs. overnight and that does not work for me. Finally my manicurist gave me some lotion from Vietnam and, believe this, it helped it within three days. Three days later.......it was GONE.

Now I can get my nails done again. 

That problem is fixed.

Now........

All I care about is that I lose weight......

and the fatigue........

and the joint pain.........

and the weight........

IS IT HOT ENOUGH FOR YOU??

It doesn't make any sense.

I live in Las Vegas.

And I HATE the heat.

I have to say one thing about Fibromyalgia. The internal thermostat definitely doesn't work! I don't like it too hot and I don't like it too cold. I don't like it real windy. I love the rain but I hate the humidity. 

I'm also a pain in the ass.
Anything else I don't like?

But mostly, I hate the heat.

Living in Las Vegas in the summer is like standing in front of a hair dryer. Just turn it on the hottest setting and point it at your face and voila! You're in virtual Vegas. We are in triple digits and I'm just not ready for it. The way I see it is that you can put on sweaters and jackets to stay warm but you can only strip down so far. 

Hot is hot.

And it sucks.

I guess we just can't regulate our thermostat. Usually we have problems with one extreme or the other. As you can guess, mine is the heat. I do much better when the weather is cooler. True to the general theme of Fibromyalgia, other people cannot tolerate the cold weather. Most of us do agree, however, on humidity. We don't perspire as easily either. Maybe that's why the heat really gets to me. Could this be due to my thyroid imbalance? Or is it just another symptom of our hypersensitivity?

Basically, it comes back to that pesky hypothalamus. The HPA axis seems to be popping up everywhere.  I guess the autonomic system is out of whack. Everything seems to point to a problem in this area. What triggers it is anyone's guess but when you trace back the symptoms that we have........well, it all seems to point back to this area of the brain. 

We have malfunctions in the two key areas of the brain. The autonomic system and the HPA axis. These two areas are the major pathways for the bodies response to stressful situations. Considering that we don't handle stress very well...........well, there you have it.

Here's what I don't get. 

What pioneer rode across the country.....in the summer........

Settled on what is now known as Las Vegas......

And said.........

"oh, this is PERFECT....let's settle here!!???"

But back to the heat.

I hate it.

I'm sitting right in the middle of fort stinking desert.

And it hasn't even gotten started.

Hello to Las Vegas in the summer.