ESREBOXETINE........GOING OUT ON A LIMB HERE

In 2009 Pfizer was in stage 3 of clinical trials.

The results were promising.

They dropped it.

2009????

I've always believed that Fibromyalgia was not on anyone's top ten list. It's been either a garbage can diagnosis or just totally dismissed as an illness. I guess there's just not enough money to be made in treating patients that live in pain. 

Please forgive my cynicism. I used to say that if doctors got the crap beat out of them with a baseball bat and had to live with that pain for weeks, months and years maybe then they would understand what living with chronic pain is like. 

Esreboxetine.

Ever heard of it?

Neither had I.

Researchers published that it linked this drug to reductions in pain and improved patients scores on the Fibromyalgia questionnaire. Even though this drug was thought to be promising and was through phase 3 of clinical trials neither Pfizer or any other company went forward with it.

Until now.

Axsome Theraputics plans to submit a new drug application for AXS-14 later this year for a potential treatment of Fibromyalgia. It will include the phase 2 and 3 data that show a significant improvement compared to the placebo. 

The best part?

Not the fact that it will help patients.

That would be too easy.

Try Axsome had to pay Pfizer 3 million bucks.

Plus, Pfizer gets 8 million of Axsome stock.

But wait!

There's more!

Pfizer gets first right of negotiation in future transactions regarding AXS-14 and an antidepressant medication they castoff now called AXS-12.

Not bad for a castoff drug they didn't want.

I have questions though. 

Reboxetine is for treating major depression. So....where does esreboxetine fall in this category?

Reboxetine is not available in the US but it is in Europe and from what I read there are a ton of icky side effects. Pfizer successfully used animal models but human one were not as successful. I'll list the link below to show why it is so controversial in Europe.

But back to esreboxetine....

Will it work?

I don't think the votes are in yet.......

Back to square one.

Psycom.net/reboxetine

I FEEL BAD FOR LADY GAGA

When someone famous
is diagnosed with Fibromyalgia
we jump on it.
Why?

If someone famous has it we will be able to validate our own problems with Fibromyalgia. Most people think this is a garbage can diagnosis so if someone like Lady Gaga has to cancel tour dates due to the pain people will have the light bulb moment and think to themselves, "maybe they aren't crazy." 

Me?

I just feel bad that she has to go through this.

We're still smiling through the tears. When people ask how we are we still say, "fine." We still get irritated at the Lyrica commercial and we still are disbelieved by doctors. We hesitate to talk about the tons of symptoms that pick and choose which day they will decide to appear. 

We even doubt ourselves and each other at times.

No matter what I still hate feeling out of control in my own skin. I hate waking up in pain and I hate to go to bed in pain. What I hate even more is appearing weak. I hate the fact that I have to say that I have Fibromyalgia. When people ask what it is, I hate telling them. I hate having to explain what the pain has done to my life.

We now have limitations and before there were none. We now look at life in a totally different way. Even when the pain levels subside there is a place within us that knows it's only a matter of time before it will rear its ugly head again. The pain and fatigue makes you retreat and the feeling of uselessness comes over you like a wave crashing on the shore.

Can we ever be the same again?
Yes and no.

I am back at a place where the pain is strong and intense. It threatened to place me back in the black hole; a place I don't ever want to be again. I escaped the dark but it was close.

What was different this time?

Right now I'm in a place that I haven't been in many years. I'm feeling strong; definitely not physically strong but mentally strong. I'm feeling a strength of purpose and it keeps me from going down in depression. I'm walking every day and it's helped more than I can say. It takes oxycodone to do it but whatever it takes is what I'll do. I wake up in the morning in pain...that hasn't changed but I have realized that the pain isn't going to go away so I need something to overcome it. 

Let me make this clear. 

I don't believe that the walking will overcome the pain but what it does is overcome what the pain can do to me.

I'm not going to stand on a soapbox and say this is the avenue for everyone. What I will say is that there's a place in all of us where we can go and be strong. I know this because we have the strength to endure the kind of pain that we do on a daily basis. We all have a very high pain threshold and people don't understand that.

But we do.

So what I'll say is that I pray for all of us to look deep inside and find that place where pain cannot touch us.

It's there.

I know it.

A CATAGORY 5 HURRICANE

I don't know if what I've been through,
can be called a flare.
A flare?
It's more like a bomb went off.

This has been a difficult post. I want to convey how bad this flare actually was and balanced so that the people I care about don't worry. The worst has passed but I've never, since my diagnosis, been through a time as bad as this one. Fibromyalgia is sneaky. You can be fine one day and crash the next. Heck, you can be fine one minute and crash the next and that is just what happened to me. I've had bad days and fair days and semi-ok days. So what's the big deal about this time? What happened? I was blindsided. 

I went into denial. OK...It will be better in a few days. Then I went into a soul sucking vortex of pain and the inevitable depression that kind of pain brings with it. In other words, the twins visited with a vengeance. Maybe I should have gone to the doctor looking like I felt; something the cat just dragged in the house, something that would scare babies and small children. Maybe I shouldn't have tried to suck it up and put on my big girl panties. Maybe, maybe, maybe. I think I'm conditioned not to admit this kind of pain. The pain that makes me feel weak.

So what did I do?
I went off the grid.
I didn't want to go anywhere.
I didn't want to see anyone.

I tried the doctor. His answer? Just up the opioid. I didn't want to go there. They truly scare me. I respect the power of these medications and I don't want to go down that slippery slope. If I can't deal with it on 5 miligrams then I will just have to try something else. Binge watching Two and a half Men, Big Bang Theory, Criminal Minds and Blue Bloods? Nope. Didn't work but it's a pretty good distraction. Let's try something else.

Let's start with balneotherapy. Ha! I got in the bath with Epsom salts.

Usually I can stay in the tub and get through the aches. This, however, was not the icky ache. This was the voodoo pain that was stabbing me in every joint that it could find. 

And it didn't let up.

When a flare like this hits it just doesn't go away. From the moment we open our eyes to the moment we close our eyes we're engaged in battle. We all think we're wimps but nothing is farther from the truth. We battle depression that springs from pain. We battle constant pain that ranges from throbbing to gut wrenching. We battle ourselves because we constantly think that we're inadequate. Being in jail handcuffed and bound is so tough to take. There will be limitations on body and psyche. 

Limitations?
Throbbing?
Gut wrenching?
I flew by that about day 5.

I decided to put the covers over my head and just give in. There is a time when it's appropriate to surrender and though that truly goes against my nature, I did it. I really understood how people can just give up. Now, I do believe that attitude can help or hinder just about everything in your life. It can push us beyond "the can't." I understand that. But, there are times it's hard to find no matter how much we try. I was in one of those times. I threw myself every pity party there was and it still didn't help. I tried to tell myself that if I would just improve my attitude then my symptoms would go away. 

They didn't.
It made me think that I was the master of my own demise. 

I think the problem is that there is no middle ground. We are not allowed to be tired or have pain. We're supposed to just suck it up and multi-task our little stressful lives to the fullest. We're supposed to be tough and push through pain and fatigue. It's not too much to ask is it? Life is supposed to be lived and if we can't do that it's because we don't have the emotional strength to deal with pain. People think we have more of a defective mindset rather than a real illness. If you are ill and you give in to it....you are weak. Now, even if the pain is severe you are expected to just take a Tylenol and deal with it. Well, that's fine for the short term but evidently the powers that be figure that, for the long term, liver damage is better than addiction. They can't even find a middle ground.

I read about how to cope. 

I know it.

I use it.

But sometimes it just doesn't work.

Sometimes you just have to bow your head...

Say a prayer....

And weather the storm.

KETAMINE FOR FIBROMYALGIA? NOT YET.

On the street it's called Special K.

It's a horse tranquilizer in veterinary medicine.

It's a money maker for chronic pain.

I get it. Sometimes the pain gets too much and we're at the end of our rope. We want to reach for something, anything that can promise relief from the pain. We just need to be careful that we are not reaching for something that can do more harm than good.

Ketamine infusion therapy is big business in the chronic pain world. A single infusion can cost $2000 a treatment and, believe me, the recommended course is definitely NOT  a single treatment.

Ketamine is used to produce a loss of conscienceness. It's used as a general anesthetic but because of the hallucinations that it can cause it's not the primary choice. It is used by compounding pharmacies as a cream with lidocaine and ketoprophan as a topical pain reliever.

This drug is no joke.

It increases your heart rate and blood pressure. It can cause hallucinations, dizziness, nausea, blurred vision, nightmares, memory problems and if used long term liver abnormalities. It induces a state of disassociative anesthesia. 

Scary.

Years ago a study was done with 34 Fibromyalgia patients. They got a low dose Ketamine infusion followed by a dextromethorphan treatment. 19 responded to neither drug, 10 were favorable to both, 3 were helped by the ketamine but not the dextromathorphan  and 2 were helped by the dextromethorphan but not the ketamine. Link to study

There are sites offering Ketamine therapy. Everything about Ketamine states you should be monitored closely due to adverse effects but there are places giving you this therapy on an outpatient basis. Now they do tell you to stay with someone so if you have any ill effects they can get you to a doctor. Gee, that's comforting. I may have someone watching me who hasn't got a medical license and they are the ones to watch for adverse effects?  They also tell you that it may not work and this is a totally elective therapy. 

It gets even better. There is a Ketamine Coma Therapy being offered in other countries. It is given in extremely high doses so that a coma is induced. This, obviously, is not approved by the FDA. 

Back to the infusions......they tell you that if you want it YOU NEED TO SATISFY YOURSELF by the research YOU DO through search engines. In other words, we just give it to you and if there's a problem you should have done better research. To me, that borders on negligence. We need qualified people that will tell us the realities of medicine and what it can do. We shouldn't be the ones doing the search and then telling the doctor it's ok. 

It also tells you tough noogies because you may elect to proceed knowing it may have no benefit. They also tell you the greater number of infusions you have the greater the benefit. 

At 2 grand a pop that sounds like double speak to me.

Just keep paying and pray it helps.

I'm not saying it may not help some people. It might. 

Everything in me shouts NO.

Everything I read about this drug screams "dangerous in the wrong hands."

It's a street drug that packs a wallop.

It can kill you.

Please be very careful if you are going through with this therapy.

You need to be watched carefully.

Personally?

I wouldn't do it.

*** This post was written about a specific place and person which shall remain nameless. There are legitimate uses by doctors and hospitals. 

THE JESUS SHOT.

If it sounds too good to be true.

It usually is.

And now, they add Jesus to the mix.

I'll never understand people who, for their own benefit and marketing purposes, throw the name of Jesus into the mix so people will (excuse the word) flock to their practice and get the shot.

There are millions of people in pain and, if you are Christian, he's marketing right to you.

First of all, let's do a little background on the doctor. His name is John Michael Lonergan. He is approximately 67 years old and spent part of those years is prison for mail fraud, tax evasion and health care fraud in Ohio. His medical license was permanently revoked in Ohio and Oklahoma gave him a provisional license which requires supervision. Now, it seems he's practicing without supervision.

Hmmm.....sounds legit already.

Now, he's in Oklahoma peddling a lovely little shot that will cure you from chronic pain. 

Oh, and that will be 300.00 .....

Dr. Mike...doesn't that sound so friendly and helpful?

No one seems to know what is in the injection. Why, in heavens name, would you EVER inject yourself with something when you don't know what's in it. This injection will cure all ailments, not just chronic pain. 

People in chronic pain are usually desperate and will try anything for relief. This is a predator that is injecting people with God knows what. He's misrepresented himself as part of the military and misrepresented EVERYTHING ELSE. He claims he was in the special forces but no one can seem to find anything about him and he was investigated about stolen valor.

It can't be substantiated but a Dr. Schrick told reporters that is a mixture of Kenelog, Vitamin B12 and dexamethasone. Oh, and it had another less exciting name: inflamation prototcol. It is very frightening to me that people will try anything without thoroughly investigating it first. If the doctor won't tell you what's in it you shouldn't be letting him inject it into your body. Look up the side effects and decide what is best for you and discuss it with your doctor. Speaking of doctors; look up yours and make sure he has an active license and is in good standing with the state medical board.

It's very sad that some people will use the name of God just to enrich themselves.

Dr. Lonergan? 

He works at the Priceless Beauty Spa.

Oh yeah....he can cure chronic pain.

And I want to be an astronaut when I grow up.

If it looks like a duck,

Sounds like a duck.

Quack.

TONMYA AND FIBROMYALGIA....MY OPINION

It's been awhile.

But now, it has a name.

Tonmya.

A year or so ago 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 of TNX102 (Tonmya) that was taking place  so I was thrilled that I had been given the opportunity.

I really 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, which is 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. 

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. 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.

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! It's been prescribed off label as a sleep aid. What I didn't know is that there isn't any benefit with this drug after two to three weeks. Actually, what is said was "the evidence of effectiveness for prolonged use is not available," and everything I've read says that this drug should not be used long term.

So why is this different? 

Flexeril is still Flexeril.

Blech.

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. It's 2.8 mg of cyclobenzaprine in this formulation. Tonmya is currently being evaluated in the 500 person AFFIRM trial for fibromyalgia. Patients have to report a reduction in pain from the baseline after 12 weeks. It is also being evaluated for safety as well as the effectiveness of the drug. 

So far approximately 42% of the patients experienced some kind of tongue or sublingual numbness. More studies will need to be done to evaluate long term effectiveness. Also they need to study if it will interact with any of the medications currently approved for Fibromyalgia. 

This isn't some ripoff company trying to float and old drug into a new "big fix" for Fibromyalgia. This doctor had a thriving practice and then committed what he said was, "professional suicide" by going into research on a central nervous system problem like Fibromyalgia. In his opinion, non restorative sleep changes the central pain pathways and if part of that can be fixed then patients should see a reduction in pain. 

We really do need the sleep. I don't know about anyone else but it's not very often that I get refreshing sleep and I can tell a big difference on the rare occasion that I do. Another thing I found interesting was 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. 

Yes, it's Flexeril.

But, it's not the same old dosage.....

and it's used in another formulation.

I think it should be given a chance to prove itself.

Let's not jump on the bandwagon and trash it until we know.

Just sayin'..................

It could be an important piece of the puzzle.

BRAIN STIMULATION? NOT SO FAST.....

Sorry in advance.

This is simply shocking!

I wrote about this protocol before and in my typical tongue-in-cheek response I conjured up visions of Frankenstein and melting brains. This actually has been researched for centuries and there is real validation. For me? Call me old fashioned but I really believe there are things you shouldn't mess with and randomly shocking your brain is one of them. I know there are times for this protocol; actually they call it brain stimulation, and it can be used for major depression and seizure therapy. 

How would you like to be in that clinical trial?

Just imagine......you can stimulate your brain and have no pain. Whoa.....I should be in advertising.....stimulate your brain and have no pain. What a campaign.....there I go again.... it just never ends......anyway......

It's actually called High Definition transcranial Direct Current Stimulation or HD-tDCS. You put a few electrodes on your scalp and voila!  A few electric shocks later.....your brain releases opioid like painkillers. 

Sounds simple......

Wait...it's a 20 minutes session and it said it reduces the pain perception and it is safe using established safety protocols. Hmmmm.....I may be one of those people that are sensitive to wording. Must be from years of reading the fine print in contracts. 

There can be some side effects. A phosphene (a brief flash of light) at the start of stimulation, headache, dizziness and nausea. Ok, I'm gone at the mere mention of nausea. The one to two milliamps that are used isn't enough to make neurons start firing but the therapeutic value hasn't totally been established either. Granted the dose of electricity is very small compared to the doses used for clinical depression or seizures.  Studies have indicated that it is safe for a single use stimulation but results aren't in for long term stimulation. 

My problem with all of this is people get on the bandwagon and some person will figure out a way to have a DIY (do it yourself) way to assemble this and start opening clinics. Once that happens all legitimate research is tainted. It will absolutely fall under the category "that some is good, more is better and too much is just enough." Laboratories and universities have protocols in order and once you get outside of that arena all those safety protocols go out the window. 

I just want to know is how they figured all this out. 

How many brains did they have to melt?

Anyway.....the kicker?

The researchers don't know why this works. 

That sentence speaks for itself.

Again, with proper safety protocols...........

IT'S 2016 ALREADY?

This year has gone by so fast.

I've turned around and it's gone.

But hey.

I can't believe how fast life has gone.

I look back at all the resolutions I've tried to keep. The operative word is "tried." Looking back at it, I don't think I even tried to keep them. I know it sounds good but it just doesn't happen. I think I had it right when I said, "I'm the idea man. Follow up isn't my strong suit."

So what do I do?

I'm going to list the "resolutions" that I think everyone should adopt. 

If you can't tell the last sentence was dripping with sarcasm.

A few years ago I wrote that I resolved to be more accepting of me. I knew that I'd have bad days and good days but this is a chronic illness that has no cure. Ok....I get that. Time took care of part of that. Accepting of me? Has or will that ever happen? Probably not. I'm not very accepting when the voodoo pain hits. I'm not real accepting when the pain drags out for days on end. I'm not real accepting when I see commercials for the lousy drugs that haven't done much for fibromyalgia pain but have side effects like weight gain. For me, that is a side effect that negates any benefit whatsoever. So am I accepting? Not when I look in a mirror....yeah, I really do miss my neck.

I know....that's not a fibro thing. That's an age thing.

Golden years my fanny.........

The one that really makes me laugh is the resolution that I would check my attitude at the door when the pain gets overwhelming. Oh yeah.....that WILL NEVER happen. What was I thinking??? Attitude in the toilet is the only outlet I have when the pain doesn't stop. If I didn't have sarcasm I wouldn't know what to do! Has anyone EVER been sweet and nice when pain is stabbing at your body like the little voodoo doll it's named after? Me either.

Then I always resolve to be kinder to my body. You know...if you push you will pay. Well, I always push because I never know what the day will bring. If I didn't push I wouldn't do anything. So I guess I will have to learn to pay.

The one thing I can do is remember that it could be a whole lot worse. I know that doesn't mean much to people who feel like they're at the end of their rope. It's hard to see the light at the end of the tunnel when you're really deep in that tunnel. I am not trying to minimize what chronic pain can do. It can bring a truly strong spirit down to their knees. What I'm trying to say is to hold on with both hands and know that it will get better. Pain does change you but we need to stay strong and fight those changes.

What I've realized is that I never really appreciated all the good days before Fibromyalgia became a constant in my life. Maybe that's why I push on my good days. I do appreciate them and since they are few and far between I tend to make the most of them. It's interesting that people think we have a low tolerance for pain. Nothing could be farther from the truth. I can tolerate pain and I tolerate it on a daily basis. The levels make all the difference but the pain is never truly gone. Most of the people I've talked to feel the same way. We're not wimps. So it comes down to the difference between pain tolerance and pain thresholds. I have a very low pain threshold but my tolerance is very high. Pain tolerance is about the levels of pain that a person can take before breaking down physically or emotionally. Pain threshold is the point that the stimulus is perceived as pain. 

So, am I making resolutions this year?

No.

I never keep them anyway. 

It's too bad I can't write Dear Abby.

Then there would be more advice....

I could ignore.

I wish for a happy, healthy and prosperous New Year...

for you all.

Happy 2016!

Rosemary

I JUST LOVE THE HOLIDAYS

It's that time of year.

Holidays and parties.

And you are just exhausted.
More than exhausted.
Trashed.

I read somewhere that it's a good idea when you have a chronic illness to lower your standards for holiday shopping and baking. Lower my standards? How much lower can they go before I just put the covers over my head? It's bad enough that I feel pain on a daily basis, I really don't want to inflict anyone else with that on the holidays.

Then again, I don't think anyone holds the standard that I hold to myself. 

When my daughter was little we had to run from home to home to celebrate. By the time the year was over I was glad that it would be a whole year before I had to do THAT again. Then as time went on and pain entered my life I began to resent it even more. I had to stop and remember, that for me, the reason of the season was not rushing around for the perfect gift and baking until I dropped. I had to remember that I had the perfect gift and I had a wonderful family that it was a joy to be around. 

So, how do I get through the holidays?

All I can say is thank goodness for Amazon. Well, I'm going to expand that to the whole internet. What was it like before? It's hard to remember life before one-click buying. I just don't have it in me to brave the crowds anymore.  What would I want for myself and others that have illness as a part of their lives?  I would want a magic wand to conjure up a cure for myself and others.

So, now the craziness of Christmas is over and in just a few days it's the New Year. I've never liked going out New Years Eve. It's just not something I like to do. We usually go to dinner early and we're home before nine. Let everyone else party in the new year. I will watch the ball drop from my nice warm bed.

I really need to start thinking about my resolutions....

That I never keep........

But, I hope everyone had a wonderful holiday.

Now, we're on to 2016......

Oh my gosh.........

2016???

Wow........

Where did this year go???

WE'RE ON HYPERDRIVE

I keep reading the study.

Over and over again.

Is it that simple?

Can it be that simple?

I have questions.

There is a study that was recently published that shows altered MRI responses in patients with Fibromyalgia to, what should be, non painful sensory stimulation. Basically, the study showed that we are hypersensitive to everyday sensory stimulation. Our brains don't process the stimulation correctly. 

When it should be stored in the background we keep it front and center.

Plus, we don't initially recognize it.

This falls in line with the study by Dr. Frank Rice and the AV shunts in our hands. It seems that the nerve endings in the AV shunts in the palms of our hands hold the secret of Fibromyalgia. The AV stands for arteriole-venule which, up until now, just regulated blood flow. Now it seems that an over abundance of these nerve fibers are the source of our pain.

It's possible.

Anything is possible.

But this brings questions. Does that mean that these excess nerve fibers were a genetic anomaly? If that is the case then are they able to remain dormant and then be triggered by an illness or trauma?

Most of us can pinpoint when the pain started. For me, it was trauma. I don't understand....did the trauma cause my palms to grow excess nerve fibers or were they there and dormant. Can this be genetics?

On the other side.....I can always feel a flare coming on because it starts with my hands. 

They summarize that the blood flow is responsible for the muscular achiness and pain. The fatigue is from a build up of lactic acid and inflammation. It sounds like that triggers the brain going a little haywire.  These shunts could be keeping blood flow from reaching deep into the muscles. As far as the brain going haywire....we all know what happens then.....

We can't sleep.

The interesting thing, to me, is that these shunts are critical for thermal regulation and our metabolism. It's that why some of us have heat or cold intolerance??  As far as our metabolism goes......could it be why this is so closely intertwined with our thyroid?

If this is the case why do some medications work for some people and not others? What about all the symptoms. Can it all be due to excess sensory fibers in our hands??

I'm thinking about this.

But I still have questions.

I think this bears watching.....

but now, when I feel a flare coming on......

And I'm rubbing my hands.......

I'll take notice.