Dr No (or Not Yet)

A resourceful Australian agent seeks the cure to the persistent symptoms of Fibromyalgia (…and the disruption of the American space program!)Dr No

I’m part of the study!…Not sure what part, though.

No longer is Lyrica, Voltaren, Tramadol, Endone or anything stronger than Panadol living in my pill organiser. I have been weened off everything.

Today, I went for my second appointment at Emeritus Research. I had pretty much written-off my weekend, just in case I had side effects from whichever drug they put me on but (please press)

Today I was shown how to use my electronic diary…and that’s it. How disappointing: I have to wait ‘til next week before I start whichever regime I have been randomly chosen to undertake. I will be (randomly) assigned to one of 4 groups: Placebo, 300mg Lyrica, 15mg Mirogabalin or 30mg Miroglabin. There will be regular check-ups for the entire time.

So, until next week…

NOTE: Emeritus Research is still recruiting for the study, if anybody is interested. Click for  the Consent Form and information. Contact Daiichi using this email address – SM_DS5565_FM_Info@incresearch.com.

As well as the 1000 person study in the US and Canada, Daiichi is also recruiting in:

  • Campse and Coffs Harbour, NSW, Australia;
  • Maroochydore, Sherwood and Southport, Queensland, Australia;
  • Hobart, Tasmania, Australia;
  • Malvern East, Victoria, Australia;
  • Tallin and Tartu, Estonia;
  • Baldone, Jekabpils, Liepaja, Ogre and Riga, Latvia;
  • Auckland, Hamilton, Nelson, Tauranga and Wellington, New Zealand;
  • Banska Bystrica, Bratislava and Dubnica Nad Vahom, Slovakia; and,
  • Reading, Berkshire; Chesterfield, Derbyshire; Wellingborough, Northamptonshire: Atherstone, Warwickshire; and
  • Belfast, United Kingdom.

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Shaken…not Stirred

Purple bondI’m 007…really! That’s my identification number for the Daiichi Sankyo Mirogabalin study. Today, I went for my screening interview.

I got to Emeritus Research at 11am. The place looks like any other office…with 3 assessment rooms at the back, filled with medical equipment. It seems a little disorganised and haphazard; but I’m looking forward to being involved.

I had a meeting with a nurse practitioner and a doctor. They took a very, very long history, asking questions about almost EVERYthing to do with my medical history (including a questionnaire called the MINI, which I must say is just plain stupid!). I was required to give a urine sample (to check if I am pregnant), some blood work and an EKG. The doctor did a relatively quick physical and, of course, checked all my pressure points. All in all, with a few technical issues, it took about 2 hours.

The first part of the study is 13 weeks long. I have to come off the Lyrica that I am already on. Then I will be (randomly) assigned to one of 4 groups: Placebo, 300mg Lyrica, 15mg Mirogabalin or 30mg Miroglabin. There will be regular check-ups for the entire time.

After the 13 week trial, there may be an opportunity to enter the 52 week Miroglabin trial.

So, now, I’m waiting two weeks to see if I’m part of the study.

NOTE: Emeritus Research is still recruiting for the study, if anybody is interested. Click for  the Consent Form and information. Contact Daiichi using this email address – SM_DS5565_FM_Info@incresearch.com.

As well as the 1000 person study in the US and Canada, Daiichi is also recruiting in:

  • Campse and Coffs Harbour, NSW, Australia;
  • Maroochydore, Sherwood and Southport, Queensland, Australia;
  • Hobart, Tasmania, Australia;
  • Malvern East, Victoria, Australia;
  • Tallin and Tartu, Estonia;
  • Baldone, Jekabpils, Liepaja, Ogre and Riga, Latvia;
  • Auckland, Hamilton, Nelson, Tauranga and Wellington, New Zealand;
  • Banska Bystrica, Bratislava and Dubnica Nad Vahom, Slovakia; and,
  • Reading, Berkshire; Chesterfield, Derbyshire; Wellingborough, Northamptonshire: Atherstone, Warwickshire; and
  • Belfast, United Kingdom.

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It’s a Knock Out?

Daiichi Sankyo, a Japanese drug company, is confident it’s struck gold with its’ new drug, Mirogabalin. Daiichi Sankyo believes it will be more potent, have fewer side-effects and be longer-acting than Lyrica. That’s could be a one-two punch combination for many of usmouse who either didn’t derive benefit from the Lyrica or not enough benefit to stay on it.

A major fibromyalgia drug trial is underway in the U.S and Canada. (Want to be part of it? Contact Daiichi using this email – SM_DS5565_FM_Info@incresearch.com. Ninety-four study locations are present in the U.S. and Canada.).

Daiichi Sankyo believes mirogabalin is a significant upgrade on Lyrica. A 2014 study suggested that mirogabalin’s may be 17 times more potent than Lyrica. Both drugs bind to calcium channels that have been implicated in the production of neuropathic pain. Mirogabalin is believed to bind to a calcium channel subunit that has strictly analgesic properties. Lyrica, on the other hand, also binds to another subunit that has central nervous system effects – this is what may be responsible for its side effects.

A 1,000 person U.S./Canadian trial is assessing mirogabalin’s effectiveness in fibromyalgia. The trial makeup – putting the two drugs head to head – indicates Daiichi wants to topple the frontrunner and install mirogabalin as the preferred drug for FM.

Read more: The Next Lyrica? Thousand Person Fibromyalgia Drug Trial is Underway

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Pain or No Brain?

Ages and ages ago (except it doesn’t feel that long ago – doesn’t time fly when you’re in a fibro fog!), I (with my doctor’s advice) weaned myself off Lyrica to see if we could find a better way to deal with this condition. If you followed the posts, you’ll remember that I ended up at Step 1 again and back on it…almost immediately.

Basically, it seemed, I was given the choice of being in pain (no Lyrica) or no brain (with Lyrica). I chose no pain.

I am beginning to question my choice…as my brain and everything in it quickly turns to mush.

119. fibro fogLyrica (and Neurontin, by the way) blocks the formation of new brain synapses, drastically reducing the potential for rejuvenating brain plasticity – meaning that these drugs will cause brain decline faster than any substance known to mankind! (This is not me being OTT – this is a quote by some-one else.)

Synaptic plasticity is a key feature of nerve architecture that enables your brain to tolerate stress, recover from trauma, and make changes. That’s how your brain bounces back from intense stress (or not, in our case). Hmmm….and that could be why I just can’t seem to quit smoking. Our brains, on Lyrica, are no longer flexible or “plastic.”

Doctors use them for all manner of nerve issues because they are good at suppressing symptoms. However, can we justify this use now that the actual mechanism of the drugs is finally understood? – they are creating a significant long-term reduction in nerve health.

148. fibro fogTo make matters worse (yes, they can get worse), antidepressants block the action of acetylcholine. What does acetylcholine do, you might ask? It is the primary neurotransmitter involved with memory and learning. And, how many of us take antidepressants? I know that I do. See what I mean by things getting worse?

Can it really be right to force us to make this kind of choice?

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A Voice for Fibromyalgia?

Leah Tyler

This has been re-blogged from Leah Tyler at the Chronicles of Fibromyalgia:

Dear Pfizer,

Last night one of your commercials for Lyrica came on TV. In this ad a woman claimed her overactive nerves, caused by Fibromyalgia, gave her pain and kept her from doing the things she wanted to do in life. Obviously she went on to tout the praises of your drug, but I wasn’t listening. Instead, I was hung-up, obsessing, and ranting and raving over the use of one word, wanted. Fibromyalgia kept her from doing the things she wanted to do in life? Like rock climbing or going to an Eminem concert? Because this Fibromyalgia patient over here experienced a completely different reality. Not only did Fibromyalgia keep me from doing the things Iwanted to do, it also kept me from doing the things I had to do, like washing my hair and going to work. And I know a hell of a lot more patients sing my song than Miss Wanted To Do’s.

I have added this video as we don’t have ads for prescription drugs on TV (and I’m not sure about all other countries):

Needless to say, as a nine year veteran of Fibromyalgia, I found this phrasing offensive. In short, here’s my beef; You’re $opping up the dough off a disease that isn’t technically a disease, because nobody knows what causes it. So it wouldn’t hurt too much to throw us patients a bone, would it? Because we’re in a pickle and sure could use your help. Not only is Fibromyalgia the leading pain condition diagnosed in the USA, patient symptoms run the gamut, with a range of fluctuating severity. It affects everyone differently, and to make it even more convoluted, the treatments do, too. Please understand I am an educated consumer. In no way am I holding any pharmaceutical company responsible for sourcing the cause and cure of this mysterious ailment. And I’m well aware of how expensive the process of developing a drug, testing it, and bring it to market actually is. I’m even hip to the efforts your company invests in regarding Fibromyalgia awareness and cause advancement. But maybe it’s because of these reasons I’m actually pissed at you.

I know you pay a pretty premium for the advertising, but as of right now, Pfizer, you are the voice of our illness. Countless patients have lost their ability to function from Fibromyalgia, along with their jobs, families, friends and homes. Fibromyalgia is a devastating reality hotly debated in the crossroads of modern and psychiatric medicine, yet nobody can deny the number of patients is only growing larger. As the only other source of the word “Fibromyalgia” to many people in our society, other than ‘strange Aunt Sally who doesn’t like to leave her house’, you would do the aforementioned injustice a world of good if the chick on the Lyrica commercial said had. ‘Fibromyalgia kept me from doing the things I had to do in life.’ It would give millions of people some much-needed validation.

Thank you for your consideration,

Leah Tyler

I’m probably looking at this from a different point of view than most: I have been trying to encourage all of us, via this site, Facebook and Twitter, to become a voice for Fibromyalgia by sending emails, sharing posts or tweeting; and, then, on May 12th, lighting up their home with purple bulbs (this part is the only bit that may require some physical exertion). (Don’t know what I’m talking about? Check this out.) However, due to the very nature of our condition, it is so difficult to get many of us to actually do any of this…so, yes, it is sad that, despite how hard some of us try, Lyrica ads are the only voice for us!

 

Int Fibro

Drugs for Fibro: How Good Are They?

by Dr. John Quintner from NationalPainReport.Com

john-quintner-300x300John Quintner, MD, is a rheumatologist and pain medicine specialist in Australia who recently retired from clinical practice.
He has published numerous articles on chronic pain in Pain Medicine, Clinical Journal of Pain, The Lancet and other medical journals.

Most fibromyalgia sufferers will at some stage be offered a prescription for one or more of the officially approved drugs – Lyrica, Cymbalta, and Savella.

Many will ask their doctors two important questions: How good are these drugs and what harm can they cause me?

Many would be surprised by the answers they get – if the doctor is willing and able to provide them.

bigstock-Out-of-focus-woman-extending--34477478The concepts of NNT/NNH

One way to assess the effectiveness of drugs for pain management is by looking at the Number Needed to Treat (NNT) value.

The NNT value for drugs used to treat specific painful conditions is derived from large clinical trials that record the number of patients who report 50% or more reduction in their pain, compared to results from a placebo. The lower the NNT, the better the drug.

For example, if 10 patients with a specific condition are prescribed a drug and only one of them reports relief of pain, the NNT value for that drug is 10. This means that the other 9 patients will find the drug to be ineffective.

Continuing on the same theme, the potential for drugs to cause harmful side effects is expressed by another value – the Number Needed to Harm (NNH).

The NNH values for the three fibromyalgia drugs gives us an indication of how many patients need to be treated before one of them will report a harmful side effect. The higher the NNH, the safer the drug is.

By the way, it is well known that people taking placebo drugs can report adverse events.

NNT for Fibromyalgia Drugs

For Fibromyalgia patients, the NNT for Lyrica is 10for Cymbalta it is 6; and for Savella it is around 8-10.

This means that only one out of 10 patients taking Lyrica (Preglabin) will have pain relief of 50% or more. Only one out of 6 taking Cymbalta (Duloxetine) will have relief of pain and only about one out of 8 taking Savella (Milnacipran).

NNH for Fibromyalgia Drugs

The overall values for side effects of each drug, when compared to placebo, and expressed as NNH are as follows: between 6 -18 for Cymbalta; between 7-14 for Savella 7-14; and around 6 for Lyrica.

This means for every 6 patients with fibromyalgia treated with Lyrica, one of them will report a harmful side effect. There is a wide range of NNH’s for both Cymbalta and Savella.

Some adverse effects are relatively minor and will not deter a person from taking an effective drug. Other adverse effects are more serious and can be a reason for discontinuing the drug.

In the case of Lyrica, randomized controlled trials have shown that doses of 600 mg daily produce drowsiness in 15-20% and dizziness in 27% to 46%.

Other side effects include dry mouth, weight gain, peripheral oedema (swelling). In another important review, it was found that treatment was discontinued due to adverse events in one out of 4 patients.

In summary, a minority of patients will report substantial benefit with Lyrica, and more will have moderate benefit. Many will have no or trivial benefit, or will discontinue the drug because of adverse events.

Is this the sort of information that patients would like to have given to them?

In my experience, the answer is a resounding YES. But as each person is a unique individual, it is impossible to accurately predict who will and who will not like a particular drug.

Doctors are men who prescribe medicines of which they know little, to cure diseases of which they know less, in human beings of whom they know nothing.”

These oft-quoted words by the French philosopher Voltaire [1694-1778] still have a ring of truth about them. We now know much more about the drugs we prescribe, and about the various diseases we have uncovered and classified. But we still have much to learn about the responses of individual human beings.

Those who have been awarded a diagnosis of fibromyalgia find themselves in a “double bind.”

On the one hand, the very diagnosis can arouse disbelief at all levels of society and, on the other hand, the available drugs afford most of them little, if any, relief of pain.

Where Have I Been?

So, I’ve been MIA (Missing In Action)…why?

I have been slowly weaning off my Lyrica (see posts below for previous updates) to see if we can find something else that will allow me to feel less pain but with less side effects.

dose last

And I have finally made it to Week 6…

No! I do not feel miraculously better – in fact, I feel horrible. I didn’t realise what the Lyrica had been protecting me from (although it didn’t feel like much at the time). Let’s work from the head down:

  • No respite from the permanent headache
  • Very lazy right eye
  • Cheekbones growing out of my face
  • (Even more) increased sound sensitivity
  • Everything smells pungeant
  • Sensitive teeth
  • Itchy face
  • Aching neck and shoulders
  • Swollen-feeling wrists and hands (without swelling)
  • Costochondritis
  • Stomach cramps
  • Acid reflux
  • Diarrhea (whether I eat or not!)
  • Taut calf muscles
  • Swollen-feeling ankles and feet (without swelling)
  • Inability to remain asleep
  • No inner temperature control

Sounds like everybody else, right? But it seems that the Lyrica had reduced the impact of some of that. I just hadn’t realised how much. But the Lyrica also brought complete and utter fog.

And now I’m back at square 1; ready to start again, in a couple of weeks, to see if we can find a more effective medication regime, that will still allow me to think like a normal person!

Related Reading:

Hidden Pain or Thick Fog?

Now, I get it.

When I was first diagnosed, my doctor put me on Lyrica immediately; and then, it was steadily increased. If you’ve been reading this blog, you’ll know that I’m weaning off it. (If you’re not up to date, check Whatever…Nothing!) Well, I’m up to Week 4: I’m pissed off, short-tempered and in pain.

doses

It has even ruined the best part of my week: my shiatsu massage.

Last week’s massage was fabulous. This week, however, was another story; and, as I said at the beginning, now I understand how some of you can’t stand a massage.

pain 1pain 2The same place (no idea what it’s called) was incredibly sensitive but it got to the stage where if Peter touched my shoulder, that spot hurt; if he touched my arm, that spot hurt; if he touched my knee, (you guessed it) that spot hurt.

pain 3pain 4In fact, by the time the hour was up, if Peter touched anything, that spot hurt!

pain 5

Why the hell am I doing this to myself?

Well, the good news is that the Fibro Fog has lifted. So tell me, which would you prefer: the pain or the fog?

It’s My Life!

Woah! Really busy for me out in the real world – there is actually a life for me beyond Fibromyalgia Awareness…

As you know, last night was my fabulous shiatsu massage; but, before that, I had a very-overdue botox injection (or lots of little ones) across my forehead: Botulinum toxin, commonly referred to as Botox®, is well-known for its cosmetic use to eliminate glabellar lines, the frown wrinkles between the eyes (which is fabulous) frown_lines_beforeyet it can also relieve migraine-type headache, muscle tension headache, or chronic daily headache. Results can be dramatic. Some patients (about a third) who have suffered from daily headaches for years report being free of headaches for two to five months; so I’m hoping (at least) some of my head pain will disappear.

After that, it was an appointment with my lap-band doctor – basically unnecessary because, during this whole month, despite hardly eating because of teeth pain, I only lost 400 grams (that’s a poo!). Hopefully, after this whole ‘Lyrica-weaning’ process, I will start to lose some (much un-needed) weight!

Driving Miss DaisyToday I was lucky enough to receive my very belated birthday present – a matinee performance of Driving Miss Daisy with Angela Lansbury and James Earl Jones. I had seen the movie (a very, very long time ago – after googling it, the movie was around 1989 so I was 18) but I really didn’t remember the entire Jewish storyline, only the black racism. It was pretty damn cool and I had a (very uncomfortable) seat in the second row (that’s from the front!)

And now, tomorrow, it is Z’s 3rd birthday party (so I’ll see my father for the 1st time since The Letter) – he decided to have a gardening party with minimal decoration (BUM!) but I did what I was allowed to:

hungry caterpiller (window)hungry caterpiller

balloons

His real birthday is on Tuesday so I prepared a treasure chest of presents…

chest closed chest opened

and decorated the spare-room at my house for when he sleeps over.

view from door full view

We’re going to the Zoo!

Related Posts:

La ♫ La ♪ La…Lyrica(l) Lullaby

So it’s been a week since Whatever…Nothing! – that means the first week of Lyrica weaning is over.

doses

I can’t say that I’ve noticed much change: I had some huge headaches and face pain but that can be blamed on a cracked tooth that now needs a crown (bloody! bloody!); I had a couple of totally fogged out days but that was nothing really different; and today, I had an amazingly great day – just because sometimes (and hopefully more often), that just happens.

I think tonight’s reduction may make more of a change because it’s a reduction of the night dose. If Lyrica is as good at helping us sleep as they say so, then I may start experiencing some trouble. Of course, I hope not and I’m really not expecting any trouble…yet!

Week 3 (and onwards) scares the hell out of me…and you’ll get to hear ALL about it (hee! hee! Lucky you!)