A CRUEL PROLIA-RELATED CHOICE: MUST I CHOOSE BETWEEN A TOOTHACHE OR A BACKACHE?

I had a toothache - bad enough to ask my dentist to have a look.

After taking X-rays he referred me to an endodontist who took pictures with highly specialized equipment I had never seen before.   

Forty minutes and $385 later I emerged with a CD requiring an oral surgeon's special equipment to read, and got the news the the root of my upper left second molar (known in the trade as #15) was fractured. 

The ideal solution: extracting the tooth and replacing it with an implant. 

I've had this done before by the same oral surgeon since 2012 when I first went on Prolia and they have all worked quite well.

So why is this posted in JoansBackboneDisaster?"

BECAUSE (and I'm shouting right now) NOW SINCE I'M ON PROLIA THE ORAL SURGEON DOES NOT WANT TO DO THIS EXTRACTION OR IMPLANT!  

I'm not sure why this cannot be done now, but I asked him to discuss this with the osteoporosis endocrinologist (fortunately both are at Northwestern) to discuss this. 

Could the likelihood of jaw fracture be worse than it seemed to be a few years ago?

Right now my tooth is hurting and I can see no good end in sight for this.   Will I have to choose between a painful broken tooth or a painful broken back? 

So there you have it: 

One more HIT from the 

AMGEN HIT PARADE!

UPDATE: January 14, 2020.  I just discussed this with my bone endocrinologist at Northwestern.   She confirms that she knows of no SAFE way off of Prolia.  We're figuring out how to have this tooth extracted sometime in March or April right before my next Prolia shot when it is least likely to cause damage.   Until then I live with a toothache. Just one more example of daily life as I serve my life sentence in in "Prolia Penitentiary!"

http://www.joansbackbonedisaster.com/2019/04/serving-life-sentence-in-prolia.html 

UPDATE: March 10, 2020.   Oral surgeon removed the painful fractured tooth today.  Many months of toothache pain finally relieved.    I get next Prolia shot in a few weeks.  Will I be able to have an implant to replace the missing tooth?  Watch this space!  (Literally!)

UPDATE: March 14, 2020.  Site around extracted tooth reasonably calm.  But my whole bite is off. Other teeth banging against each other.  It could be many weeks before this can be addressed, and I have no idea whether I will be able to have an implanted tooth in the extraction site because of being on Prolia.   

Itchy skin continues and not much to do about that. 

I'm reading many more online accounts now about Prolia-related disasters.  I'll compile a list of these shortly.  So watch this space (not the space where my tooth should have been!)

IT'S TIME TO PLAY "THE PRICE IS RIGHT" WITH PROLIA!

Remember that quiz show "The Price is Right?"  where consumers guessed retail prices for prizes?  

Well, Amgen plays that game too with their BONEBUSTER -- uh-oh did I say that? --  I meant BLOCKBUSTER drug Prolia (r)  

Because of my vertebral fractures associated with the medical mismanagement of Prolia (r) doctors suggested I might consider getting my shots a bit sooner than the 6 months (plus the 5 days required for Medicare reimbursement).  

So I started checking prices.  The variance was HUGE!  (And I am just talking about cost of the drug itself, not the cost of having it administered by a doctor or nurse).   

I went to the Amgen website to see what their wholesale price might be, and to get an idea of how much markup there was, but could find nothing.  

So I called the Amgen "hotline" (800-772-6436) which transferred me to a line called "Amgen Assist" where I spoke with "Judy."  

Judy basically gave me the same info: I would have to run around and find the wholesalers used by each institution and find out what their prices were.  But she would not give me any information about the price from Amgen.   

Since these calls are recorded, I asked her to let me send a message for the people "upstairs" at Amgen about how confusing and unfair this policy is for patients.

Judy's response was "I'm terminating this call."   
So I gave my message to a dead phone and then proceeded to write, once again, to Mr. Robert Bradway, CEO of Amgen Corporation with these questions.  

His business address is:

Mr. Robert A. Bradway
Amgen Corporation
1 Amgen Center Drive
Thousand Oaks, CA 91320

If you are having trouble with this or any Amgen products he might want to hear from you too!

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PROLIA AND COGNITION

Now that my capacity for physical activity has been pretty well ruined by Prolia, I must rely on my cognitive ability to a great extent.  

I find myself much more forgetful now and I need to write down EVERYTHING I used to keep in my head or I will miss appointments, forget what I have done earlier in the day or week, or have a hard time concentrating on what I read.

Of course this can be related to unrelenting pain whenever I am sitting or standing, which means that my physically body is less active, perhaps affecting my mental acuity.  

But hearing reports of reduced mental capacity associated with Prolia, as well as reports of people who found their "brain fog" had lifted when they were no longer on the drug, I did a quick online search.

Here is one review of this topic that may be of interest.  
https://www.ehealthme.com/ds/prolia/cognitive-disorder/

The URL above speaks for itself.  I urge readers of this blog to have a  look.

And another in the journal Frontiers in Behavioral Neuroscience on how chronic pain (which I am experiencing because of my Prolia disaster) may affect cognitive function:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6085997/  

I'm still managing, but I'm definitely slower at tasks requiring memory and cognition.

Is this a product of age?   After all, I'm 83 years old now.

But this has not been slow gradual change -- and it has been increasingly noticeable in the last year when I have been SO dependent upon my cognitive abilities, having lost much of my physical ability following my Prolia-related fractures.

This is especially frightening for me because it is my ability to negotiate my needs via phone or internet that have allowed me to live at home and do the research needed as I try to answer my questions and gain physical strength.

A HELPFUL PAIN CLINIC M.D.

I’ve gotten some practical guidance from Dr. Maunak Rana at the University of Chicago Pain Clinic.   I've mentioned him before in this blog, and he's given me good counsel.  I see him at the U of C branch at Roosevelt and Canal.  It's hard for me to get there and back but worth it.

Dr. Rana is the only doc who, to my knowledge, carefully reviewed my MRI, and also the only one who took some more X-rays, and poked me up and down my spine and ribs, one by one, etc. to see if I would actually be a good candidate for corrective surgery.  

Although he does at least three kinds of "vertebral augmentation" surgery, he determined that these would not help me because my pain was not located directly in the spine.  This was actually a huge relief because I don't like many of the things I have been reading about these surgeries.

He is familiar with the things I'm doing with my physical therapists and alternative practitioners to build my core and help with inflammation and pain generally, especially what I experience as painful internal bruising (for lack of a better description) etc.

I first saw him as soon as I was able to get to his clinic, and now, about a year later, about every 2 months, having been for all practical purposes pretty much abandoned by Amgen -- the manufacturer of Prolia -- as well as by the other U. of C. docs who haven't much to offer for the damage I've sustained.

Like the other docs, he offers no prognosis, nor can anyone else it seems.  I only hope that I can get a little better a bit at a time so that I can live out my life with less pain and more ability to do the simple things I enjoy that involve sitting, standing or walking.

A PHARMACEUTICAL TANTALUS

Tantalus (Ancient Greek: Τάνταλος Tántalos) was a Greek mythological figure, most famous for his eternal punishment in Tartarus. 

As punishment for defying the gods at Olympus, Tantalus was made to stand in a pool of water beneath a fruit tree with low branches, with the fruit ever eluding his grasp, and the water always receding before he could take a drink.

The word "tantalize" comes from this horrific story!

Here is a picture of an item used to hold different kinds of wine and spirits.  It is called a "tantalus" after the above mythological character.  The decanters are placed rather loosely in this special tray, and it looks as if you could easily remove them.   But when you try, it is impossible unless you have a key or know the secret method required.  Otherwise, no matter how much you would like to have a sip from one of these bottles, you are out of luck. And if you try too hard to remove the bottles without knowing how, they may break!

Prolia is something like this.  Once you are on it you may be more or less "hooked."  If your shot is delayed for any reason your bones may break as mine did.  To get off of it, you may have to go to even more dangerous methods such as have been proposed to me.  And even if you do get off, it may leave behind still other problems, as have been reported in links on these pages.  

There are countless times over the past year when I have felt like Tantalus in the picture above, able to get around a little but winding up in breathtaking pain, still desperate to get off Prolia but afraid to incur the fractures such as I had during that medical disaster a year ago when my Prolia shot was delayed because of a medical center personnel change.

The drug Prolia that was presented to me in 2012 as having so many advantages turned out to be a cruel pharmacological joke, leaving me feeling much like poor Tantalus must have felt with relief always just beyond his grasp.   

I should have known better than to ever have agreed to this drug so soon after FDA approval. This was a dreadful mistake on my part.  It may be the physician's job to prescribe, but it may also be the patient's job to resist.  I fell down on that job and now I am paying for it.

Like Tantalus above, I still do not know if I will reach my goal of a reasonably pain free life.  But I continue to work hard in physical therapy and other modalities requiring much time, effort and considerable expense.  

And I will continue to share my experience with Prolia and its painful and disabling aftermath in hopes that it might spare others what I am dealing with now!

AN OPEN LETTER TO AMGEN CEO MR. ROBERT A. BRADWAY

An Open Letter to the President of Amgen Corporation: 

Mr. Robert A. Bradway
Amgen Corporation
One Amgen Center Drive
Thousand Oaks, CA 91320-1799 

November 11, 2019

Dear Mr. Bradway: 

I am writing to you as CEO of the corporation that manufactures Prolia, a drug intended for osteoporosis, which was marketed to the public not long after it was approved by the FDA in 2010.  

I was started on this drug in 2012.  With hindsight, I can see that I never should have allowed this so soon after FDA approval.  However, once on, I was present for my shot every six months as prescribed until the January of 2018.    

At that time there was a DELAY in receiving this drug occasioned by a change in medical personnel at the medical center where I was being treated.    I was told not to come in until the new doctor could see me.   But within a few weeks after the last shot was due I suffered back pain such as I had never experienced in my life, which turned out to be three vertebral compression fractures.  

I reported this to your company and have called them from time to time since to tell them how I am doing during months of physical therapy and pain management assistance.   

This has left me partially disabled due to constant pain, and has destroyed much of my active life.  From a healthy 81 year old enjoying travel, volunteer work and many activities with friends and family, I have become largely disabled 83 year old, in pain much of the time, making many these activities impossible.

That this short DELAY in receiving Prolia resulted in these fractures was confirmed by the treating physician. 

This has been further complicated by the inability of any medical practitioner I have consulted (as well as your own product advisors with whom I have spoken on the phone) in hopes of finding a demonstrably safe way for me to get OFF this drug, and this has created other problems for me, including problems with having needed dental work done. 

Over the past year and a half I have met many, many people, mostly older women, on Prolia who have NO IDEA about the danger of delay.  In a few instances women have told me that they were going to let their shot go because of a vacation or other reason, and I have been the one to warn them about the possible consequences of this!!!!    They hadn’t heard it from their doctors!!!!

I have recorded much of my experience and what I have learned in over 40 posts at my blog,  www.JoansBackboneDisaster.com, where you may find further background.  

This letter comes to you in hopes that you will review what happened to me and consider the remedial actions including the following:

1. Immediately withdraw all Direct to Consumer advertising for Prolia, most particularly your TV advertising.  

2. Make it clear in ALL advertising and other publicity, as well as professional and consumer labeling,  that:

         a. Prolia is a drug with many hazards that should only be prescribed when NO other approaches have worked;

         b. Patients must be thoroughly educated that Prolia may create other serious physical and dental treatment problems;

        c. Prolia shots cannot be delayed even for a short time (specifically using the word DELAY!), and, most importantly;

        d. Once on Prolia, it may be impossible to get off without suffering fractures, no matter what problems it may be creating, and that therefore Prolia should be prescribed ONLY after ALL other options have failed and with FULL DISCLOSURE to patients.  

3. Ramp up warnings to specifically warn medical professionals (with BLACK BOX warnings) about the likelihood of fractures after even short DELAY in receiving Prolia, and specifically emphasize the word DELAY.  

4.  Amplify the labeling on the "tag" given to patients at each Prolia injection to include a warnings similar to those above, and specifically including the word DELAY.

5.  Implement research to discover a SAFE way to get OFF Prolia for patients who need to do so for any reason, and make the results of that research available to patients and especially to doctors inquiring about this.  

It appears that I am not the only one in this predicament.  Even with my limited capacity for research I can see that many others have had experiences similar to mine.

The only saving grace for me is that now, at age 83, I probably won't have too many more years to live with this pain and disability.  

But during the limited time I have left on this Earth, and despite my limited capability because of this Prolia debacle, I'll do my best to warn others so they don't fall into the same Prolia trap that I did! 

At a personal level, I urge you to warn your loved ones not to go near this drug that has the capacity to ruin lives as it has mine.  

I sincerely hope that you will pledge to use your greater reach to do likewise to save others the suffering I have endured.  


Very truly yours,

Joan Levin

PROLIA: A VIRTUAL HOBBLE!

Sometimes ranchers put hobbles on horses -- straps attached loosely to two legs.  The horse can move about to graze but cannot run very well and is therefore less likely to run away.  Similar restraints were among the many horrors of slavery.  

I can move about a bit and I can be up and around the house and even take a walk around the block.  It's painful but I need to do it.  

Far more difficult are the few necessary trips I must make further from home - mainly for doctor and dental appointments.  These short trips leave me exhausted from the painful effort.  

The painful vertebral fractures I've been living with because of Amgen's drug Prolia and its mismanagement by the University of Chicago have been like hobbles for me.  

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TWO POETS WHO SPEAK FOR ME

 As a long time political activist, contemplating a nation gone mad with Presidentially-driven hatred and bemoaning my own condition which renders impossible demonstrating in the streets -- which I would otherwise be doing -- I turn to poetry. 

These two poems, partially memorized in years past, come to mind.  

1. Alfred Lord Tennyson,  The Death of Arthur from Idylls of the King, a saga about the life and death of King Arthur.

https://en.wikipedia.org/wiki/Idylls_of_the_King

https://en.wikisource.org/wiki/The_Passing_of_Arthur

And slowly answered Arthur from the barge:

'The old order changeth, yielding place to new,

And God fulfils himself in many ways,

Lest one good custom should corrupt the world.

Comfort thyself: what comfort is in me?

I have lived my life, and that which I have done

May He within himself make pure! but thou,

If thou shouldst never see my face again,

Pray for my soul. More things are wrought by prayer

Than this world dreams of. Wherefore, let thy voice

Rise like a fountain for me night and day.

For what are men better than sheep or goats

That nourish a blind life within the brain,

If, knowing God, they lift not hands of prayer

Both for themselves and those who call them friend?

For so the whole round earth is every way

Bound by gold chains about the feet of God.

But now farewell. I am going a long way

With these thou seest--if indeed I go

(For all my mind is clouded with a doubt)--

To the island-valley of Avilion;

Where falls not hail, or rain, or any snow,

Nor ever wind blows loudly; but it lies

Deep-meadowed, happy, fair with orchard lawns

And bowery hollows crowned with summer sea,

Where I will heal me of my grievous wound.'

John Milton: On his Blindness

When I consider how my light is spent
Ere half my days in this dark world and wide,
And that one talent which is death to hide
Lodg'd with me useless, though my soul more bent
To serve therewith my Maker, and present
My true account, lest he returning chide,
"Doth God exact day-labour, light denied?"
I fondly ask. But Patience, to prevent
That murmur, soon replies: "God doth not need
Either man's work or his own gifts: who best
Bear his mild yoke, they serve him best. His state
Is kingly; thousands at his bidding speed
And post o'er land and ocean without rest:
They also serve who only stand and wait." 

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