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.  

###

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." 

###

SERVING A LIFE SENTENCE IN PROLIA PENITENTIARY AND AN UPDATE

As "punishment" for agreeing to a new drug, Prolia, before it had been on the market for at least five years, I am now serving a life sentence, mostly on my bunk, in what I call Prolia Penitentiary.  

Actually, it's more of a form of house arrest.  If I venture from my house for more than a few hours I am punished with terrific, crushing pain.   

While much of the world has done away with corporal punishment and torture, and while cruel and unusual punishment is forbidden under the United States Constitution, it is still regularly employed here in Prolia Penitentiary, an institution which punishes escape attempts with painful fractures, and continues to inflict terrific pain even when inmates leave the grounds for a short time!    

 I'm in Prolia Penitentiary now for
taking Prolia so soon after FDA Approval.  Care to join me?
Get your Prolia shot and perhaps you can!

UPDATES!!!!

January 14, 2000:  I spoke with my bone specialist at Northwestern University today.  (Following Amgen's instruction, below, of "ask your doctor.")  I asked her if she knew a SAFE way to get off Prolia.  We discussed this for a while but bottom line is no, she cannot say that there is a safe way off Prolia, so I guess I continue my stay in Prolia Penitentiary for the time being.

We are in the process of figuring out a safe way to address the painful tooth waiting for extraction discussed in another post at: 
http://www.joansbackbonedisaster.com/2019/12/a-cruel-prolia-related-choice-must-i.html

May 16, 2019: 
.  

I spoke with an Amgen Representative today at 800-772-6436 (Amgen's consumer number).   I wanted to be sure that I was reporting this accurately.   Here is what I have learned in this and other similar calls about getting off Amgen safely (that is, without breaking bones.) 

1.  Amgen's answer to the question as to how to get off Prolia safely has been to "consult with your doctor."  They have said this to me a few times, but in fairness I wanted to be absolutely sure I understood them correctly.  Today they were impatient to the point of rudeness in reminding me that they had told me this before, so I will assume that this is Amgen's position on the matter.  

2.  I have indeed consulted with Dr. B. about this.  She told me that she had consulted with Amgen about this herself, and said they gave her no useful advice on this.    

3. Dr. B. had at one point mentioned an off-label use of the IV injectable bisphosphonate drug called  Reclast (zoledronic acid, manufactured in the U. S. by Novartis).  It looked quite frightening to me,  and she has to date given no other suggestion.  She also indicated that I was not a good candidate for this off-label procedure in any event. 

This leaves me with the conclusion that neither Prolia's manufacturer, Amgen, nor Dr. B. at the University of Chicago, knows how I can get off of Prolia safely -- that is, without breaking more bones or something even worse! 

So this fish is still caught in the gill net, with no way out!

  

THE FUTILITY OF CALLING AMGEN

Every few weeks or so I call Amgen's "consumer" number:  1-800-772-6436 (800-77AMGEN) to report on my condition and ask for advice about getting off Prolia.   

I also ask them how they are coming along with getting proper warnings on their labeling for doctors and patients, and with getting their deceptively attractive ads off television.

These calls are usually answered by a nurse or a pharmacist.  I tell them what is going on in my life because of Prolia; the disability coupled with nearly constant pain.   I also ask about other concerns (such as not being able to get needed dental work done).  

Most importantly, I ask them if they have any new information that would help me get off Prolia safely, that is, without additional fractures.  Their answers are invariably the same: "Ask your doctor."    

They should know that this is a ridiculous answer because when my doctor reported that when she actually DID call her professional source at Amgen, they could not advise her either!   (Maybe they just don't want to admit that Prolia can be a non-refundable one way ticket to Hell!)

The last time I called Amgen, the person who answered the phone reminded me somewhat testily that I had called several times before.  I said this was so but that I kept hoping that something new might have come up that could help me get off this wretched drug Prolia. 

This was my mistake, because taking the same action in hopes of achieving a different result is the height of illogic, but pain and frustration sometimes scream at me with a louder voice than logic these days!  

I make these calls while flat on my back, my only pain-free posture.  I make them hoping my questions and concerns will be forwarded to Amgen's product safety people (whose number is closely guarded by the front line people with whom I speak at 1-800-772-6436), and perhaps from there to the FDA.   I have no way of knowing for sure if this is done, so I often repeat calls just to increase they odds that they'll get to the right place. 

Besides hoping for something to help me rehabilitate from this Prolia-fed disaster, I would like to see my calls result in added warnings to discourage others from stepping into the Prolia trap as I did!    

So I urge others similarly harmed by Prolia to call 1-800-772-6436 and wade through the various "menus" until you talk to one of Amgen's nurses or pharmacists.  Perhaps your report will help bring about clearer and more direct warnings to patients and doctors, along with an end to such widespread promotion of Prolia (such as Direct to Consumer TV advertising!)   

Here is more information from Amgen about this:  
https://www.amgen.com/products/global-patient-safety/adverse-event-reporting/  

And: https://www.amgen.com/~/media/amgen/full/www-amgen-com/downloads/policies/adverse_event_product_complaint_reporting_policy.ashx?la=en 

While Amgen is required to send certain reports about information received in this way to the FDA, there is also a government  voluntary reporting form you may use for this purpose: 

https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program/reporting-serious-problems-fda Here you will find a link to the consumer friendly Form 3500B you can use for this purpose and submit electronically.