AMGEN FINALLY ADDS THE WORD "DELAY" TO THEIR PROLIA "MEDICATION GUIDE"

I call Amgen every week or two: 

1. To tell them how I'm doing after this Prolia disaster; 

2. To ask for any advice they might offer for restoring a workable, pain free body;

3. To urge these friendly reps never to go near that drug or let any of their dear ones go near it! (They all sound very nice).

4. To suggest they add the word "DELAY" to their product information instead of just words like "discontinuation" or "stopping." 

As to (1), (2) and (3) I usually get nothing useful. 

But as to (4) there was a recent change.  

The Amgen rep I spoke with today (handle "Aaron") told me that the word "delay" had been added to their information on October 2, 2019.   I asked him to send me this and he did so today, 12/30/19, via e-mail.  

While the word "delay" still does not appear in the main product labeling, it did appear appear in an attached document called "Medication Guide,"  where the text in the Warning and Precautions section includes the following: (bold italics mine) 

 Increased risk of broken bones, including broken bones in the spine, after stopping, skipping or delaying Prolia.

Talk with your doctor before starting Prolia treatment. 

After your treatment with Prolia is stopped, or if you skip or delay taking a dose, your risk for breaking bones, including bones in your spine, is increased. 

Your risk for having more than 1 broken bone in your spine is increased if you have already had a broken bone in your spine. 

Do not stop, skip or delay taking Prolia without first talking with your doctor. If your Prolia treatment is stopped, talk to your doctor about other medicine that you can take.

This included information I did not know - such as that having broken some vertebrae I am now at INCREASED risk for additional such fractures. 

I am also learning learning that length of time I've been on Prolia could also subject me to more problems, but there seems no way to escape the clutches of this medical monstrosity.  

###

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!

###

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.

PUBLIC CITIZEN SEEKS PROLIA BLACK BOX WARNINGS

Public Citizen, the consumer watchdog organization founded over 50 years ago by Ralph Nader, has petitioned the Food and Drug Administrations for Black Box Warnings on Prolia.

April 16, 2019

Link to the Petition and Related Documents:  https://www.citizen.org/article/petition-to-the-fda-to-require-a-black-box-warning-for-the-osteoporosis-drug-prolia/

Link to the Press Release: https://www.citizen.org/news/patients-doctors-must-be-warned-about-risk-of-spinal-fractures-soon-after-stopping-osteoporosis-medication/

See text of Press Release April 16, 2019 below:

April 16, 2019  

Patients, Doctors Must be Warned About Risk of Spinal Fractures Soon After Stoping Osteoporosis Medication.

Prolia’s Effects Are Short-Lived; Fractures Can Occur as Soon as a Month After Drug Wears Off

WASHINGTON, D.C. – The U.S. Food and Drug Administration (FDA) must immediately require that stronger warnings be provided to doctors and patients about the increased risk of spinal fractures when patients stop taking the commonly used osteoporosis drug Prolia, Public Citizen said today in a petition to the agency.

Prolia, which is administered by injection every six months, was first approved by the FDA in 2010 to treat postmenopausal women with osteoporosis at high risk for fracture, but its use has since been expanded to include men. Its effects last six months. Public Citizen’s petition highlights a growing body of evidence showing that patients who stop using the drug have an increased risk of multiple vertebral fractures in the spine as soon as seven months after their last dose. Such fractures can cause severe, disabling pain.

Unlike other osteoporosis treatments, Prolia’s positive effects on bone are short-lived and readily reversible if the drug is discontinued. One study cited in the petition described 24 patients who collectively had experienced 112 new spinal fractures, which represents an average of nearly five fractures per patient.

The petition asks the FDA to upgrade the warning about this risk, which is buried deep in the label, by replacing it with a more prominent black box warning at the top of the product labeling, the strongest warning that the agency can require. The petition also asks the FDA to require Amgen, the maker of Prolia, to send letters to doctors and develop updated patient brochures that warn about the increased risk of spinal fractures if the medication is stopped or a scheduled dose is missed. 

“It is critical that the FDA require a black box warning to ensure that doctors are fully aware of the risks involved with stopping Prolia,” said Meena Aladdin, health researcher at Public Citizen’s Health Research Group. “Patients should be given a patient brochure every time they receive a dose of Prolia that explicitly warns them about the risk of spinal fractures if they stop taking the medication and don’t receive alternative osteoporosis therapy to mitigate this risk.”

Read the petition.

SOME EXERCISES THAT HELP

I AM POSTING THEM HERE SO I CAN FIND THEM LATER!

They have helped me!   

 Sanjoy Stick Exercises

EDITORIAL: WHERE IS THE RESTORATIVE JUSTICE HERE?

I recently watched a program about Restorative Justice on 60 Minutes about how crime victims of have met with the perpetrators of these crimes, and in so doing so, and having accepted sincere apologies, have helped their own recovery.

Much of this blog has discussed how I have been injured by Amgen's failure to give adequate warnings to patients, and doctors as well, about its osteoporosis drug Prolia (denosumab).

Like any private corporation, Amgen seeks to make a profit for itself and its stockholder.  And as a capitalist enterprise, it relies upon a relationship between a willing seller and a willing buyer.

But the drug industry is set apart from many other consumer industries in the following manner:

1. It deals with the most personal issues in the consumer's life: life and death, health and illness, injury and recovery.

2. Choices about goods sold and their use are typically not made by the consumer.  They are made by licensed professionals, generally physicians, who are presumed to understand the effects (whether therapeutic or adverse) of the drugs they prescribe for a particular patient.

3. Prescription drugs in the U.S. must be approved by the Food and Drug Administration.  Once such approval is established, drugs may be freely prescribed by any duly licensed medical practitioner.

4.  While consumers may not be able to self-prescribe, since 1978 drug companies have been allowed to advertise their wares directly to consumers via TV and other media, creating demand upon physicians who may themselves be in a competitive situation with other health care prescribers and therefore consciously or unconsciously be anxious to please their patient-consumers.

5. Pharmaceuticals are one of the most profitable sectors in the U.S.. economy, and, individually and through associations, has demonstrated its ability to offer strong support to candidates for public office.  This in turn has created a climate in which industry profit may take first place ahead of product safety and efficacy, and may even affect the information value of product information available for doctors and patients.

So how do I, a consumer, living with pain and disability resulting from several issues in connection with a drug, go on to make my peace with what may be a permanent condition affecting every aspect of what is left of my life?

It would be remarkable to have a sit down with Mr. Robert Bradway, Chief Executive Officer of Amgen, the manufacturer of Prolia. 

It would be remarkable if Mr. Bradway would actually review the sales figures for this drug and also the figures for reported adverse drug reactions, bearing in mind the likelihood that only a small fraction of adverse drug reactions ever get reported.  

It would be remarkable if Mr. Bradway would reach out to people on medical social media whose lives have allegedly been ruined by Prolia and ask how Amgen could make this up to them, even by supporting the extra help and therapy they might need now.

It would be remarkable if, having heard these stories of lives ruined, Mr. Bradway would implement a stop on direct to consumer advertising for Prolia (as well as any direct to consumer advertising planned for their new monoclonal antibody Evenity (romosozumab-aqqg)

What is the likelihood of any his happening?

DID WHAT I DIDN'T KNOW DESTROY ME?

Currently online about Prolia:

At: https://www.prolia.com/?state=current&r=y

"What are the possible side effects of Prolia®?

It is not known if the use of Prolia® over a long period of time may cause slow healing of broken bones. The most common side effects of Prolia® in women being treated for osteoporosis after menopause are back pain, pain in your arms and legs, high cholesterol, muscle pain, and bladder infection."

I knew none of this when I first went on Prolia when I stupidly agreed to take it so soon after FDA approval!!!!!

Since that time I’ve had daily morning back pain (even before my vertebrae fractured)

My cholesterol has been high no matter what I eat.

And I get UTIs whenever I use our building swimming pool!

Are these related to Prolia?
How would I know, when N=1?
But would I go near this drug again?

These are questions I ask myself every night as I try to find a comfortable position to fall asleep, and when I wake up in pain every morning of my life!

CAN'T STAND (FOR) COOKING

My Prolia-driven fractures have affected almost every part of my daily life, including the simple task of meal preparation.   

Here are a few items that have helped me with food preparation, since standing (or even sitting up) for long is painful.

Since I only prepare food for myself, and since I find my large Vita-Mix Blender and Cuisinart food processor too hard to handle now, and since my kitchen stove is covered with food because I must buy in larger quantity than usual since I can't shop in person without pain, I've given away these large appliances and now rely on these small, but very helpful appliances.

Magic Bullet  https://www.nutribullet.com/shop/blenders/magic-bullet/

The Magic Bullet (and it's big brother NutriBullet -- which I don't have and don't need right now) is wonderful for making smoothies.   Using the little "lids" that come with it you can drink right out of the container, cutting down cleanup time.  

Cooker Steamer 

Dash Mini Cooker
Jut the right size to make an omelette (see recipe below) or heat up a soup.  

Mini Processor -- mine is a small Kitchen Aid.

CARTOON: PROLIA-- DESTROYER OF BODIES!

SOME "SHOCKING" APPROACHES

A year of disability and pain has not been easy.  I would have hoped that the doctors at the medical center where Prolia was administered, and under whose watch what was essentially a medical clerical issue left me with painful vertebral compression fractures, would have had something to offer.  But except for some osteoporosis drugs even more frightening than Prolia, this was not the case.  And all I was offered for pain were habituating, mind-numbing, painkilling drugs, which I didn't want to start.   (See: http://www.joansbackbonedisaster.com/2018/07/seduced-and-abandoned_5.html)     

I reported on some of the more conventional things I'm doing here:  http://www.joansbackbonedisaster.com/2018/07/alternative-help-to-pick-up-pieces.html and elsewhere on these pages.


But just as "all the king's horses and all the kings men couldn't put Humpty together again," this did not seem to be enough.   While slowly improving, the time I could spend sitting or standing without unbearable pain was still limited, and I was still debilitated by so much inactivity. 

As noted before, the conventional medical world had left me pretty much to my own devices to find help with rehabilitation, and had little to offer besides (as noted elsewhere) habituating pain-killing drugs.  

So my search continues for relief for pain, mindful that I'll likely encounter many scams and traps.  I do my best to check things out for safety, and I hope for efficacy.  But chronic pain is a demanding partner in my life and it's sometimes hard to resist it's urgings.

With that in mind, here are three things I'm doing now.  They all involve the use of electrical current, which accounts for the (hopefully) humorous title of this post.  I've checked them out as well as I can with the resources available to me.  

PLEASE NOTE THAT I AM NOT ADVOCATING ANY OF THESE FOR ANYONE ELSE!  I'm posting the information below for those who would like to know what I'm doing now, not necessarily to recommend them.  

1. ARPwave.  http://www.arpwave.com.  (ARP stands for: Accelerated Recover Performance) 
My chiropractor's office offers this and it appears to be used, among other things, by athletes for injury recovery. 

2. Pulsed Electro Magnetic Frequencies (PEMF).  I use a mat with this from https://www.qrs-direct.com.   
Several companies offer PEMF devices, but this is the one I'm using, on loan from an a friend. I'll likely get one for myself.  

3.  Acuscope. This is a form of frequency specific microcurrent available at a number of websites.  A therapist uses this on me and it comes from:  http://www.acuscope-myopulse.com

4. Light Therapy. I'm learning more about this so watch this space!

I may post more about these as I use them more. 

Readers interested in biostatistics will immediately note that  for me, figuring out what works and what doesn't is a complex multivariate situation where N=1, so whatever I report may not have much value for anyone else.  That said, you're welcome to follow whatever of my experience I post here! 

SPRINLY AND FRESHLY-- TWO MEAL SERVICE COMPANIES

Sprinly and Freshly are two subscription meal service companies I've enjoyed over the past few months. They deliver ready to heat and eat meals in cold packs. 

Both of these meal services are pricey but worth it as I now have no car and shopping and food prep are very difficult for me. This updates the post on a similar topic.  

http://www.joansbackbonedisaster.com/2020/03/shopping-with-covid19.html.

1. SPRINLY   www.sprinly.com 800-686-8036

Very nice meals, all plant based and gluten free, ready to heat and eat.  

Unfortunately the website is not very user friendly. After being totally confused by their website, I reached out via phone and e-mail. 

Since six meals a week (their minimum order) is way too much food for me, they helped me set up an EVERY OTHER WEEK arrangement.  (I was not able to this on my own but they were very helpful this).  

Sprinly's Help number is 1-800-686-8036.   Their e-mail is  hello@sprinly.com.  

You can choose (within their limits) how many of each dish you would like each week, but the choice is limited to six dishes (which change weekly).  All are gluten-free and dairy-free, both of which I need, and the dishes I've gotten so far have been very good.  

The saving grace of Sprinly (for me) is that 1) I don't need to spend a lot of time going over ingredient lists to make sure they are casein- and gluten-free, and 2) the the meals I've had so far have been very good!  Otherwise I might have cancelled because of the scheduling difficulties I had.  But that seems to be worked out now. 

Because they don't have a four meal option, I chose the bi-weekly option for six meals delivered every other week.  I feel reasonably safe doing this because they are cooked and plant based.  Fingers crossed!  They seem to keep well in the fridge, so half a meal plus whatever little fresh salad I put together for myself is perfect. 

2. FRESHLY  www.freshly.com 

Freshly is much easier to use.  They automatically repeat your most recent order each week unless you change or cancel in advance on their website. 

The meals are very good, the website is easy to navigate, and it's easy to pause for a week or more.  They have a four-dish option that works best for me. 

I can choose what I want from a long list of offerings.  These virtually all include animal-based foods. However, selecting what I can have takes time because most of their many offerings have gluten and/or milk products of some kind and I must spend a lot of time going over ingredient labels.  

I made my own reference list of 13 dishes from which I can choose from their menu.   (If you do not have allergies, your choices are more generous).

Here is the list I made for myself in August 2020.  (Note that they add or even change dishes from time to time).  These are (as well as I could figure out) meals without gluten or casein, the allergens I need to avoid. 

Joan's Personal Freshly List 
(Gluten-free, Casein-free)

Almond Ginger Chicken

Arroz con Pollo

Chicken Cacciatore

Chicken Livorno

Chicken Teriyaki

Coconut Curry Chicken Bowl

Grilled Citrus Chicken 

Herb-Roasted Chicken

Seared Summer Steak

Sierra Chicken Bowl

Springtime Chicken Pilaf

Tangy Sesame-Citrus Chicken

Thai-ish lemongrass bowl

Three Grain Chicken Pilaf

This list is the best I could determine in September, 2021, going through the ingredients of each dish online.

A DEAR DOCTOR LETTER FROM THIS PATIENT

ARE YOU A DOCTOR? READ ABOUT ONE PATIENT'S EXPERIENCE WITH PROLIA

ARE YOU A PATIENT?  THIS IS NOT INTENDED AS MEDICAL ADVICE

~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

March, 8, 2019

Dear Doctor,                                                                 

About a year ago I experienced vertebral compression fractures at T11, T12 and L3 associated with a delay of just a few weeks in receiving Prolia (denosumab, Amgen).  Before these fractures I was “81 going on 60.”  Retired, I was active with family, friends, organizations and travel.  Now I am “82 going on 160,” in daily pain and limited in activity. This might have been averted had Amgenwarned of the danger of even short delays in administering its osteoporosis drug Prolia.     

Now, after a year of pain, inactivity, physical therapy, and much out-of-pocket expense, I am slowly regaining more mobility with somewhat less pain.  But some pain, disability and other problems may be permanent and they have already, directly and indirectly, adversely affect my health and my quality of life. 

MY BIGGEST MISTAKE:  I should never have agreed to Prolia when it had not been on the market for at least five years after FDA approval, and before many problems,  including those resulting from delay  (or “stopping” or “discontinuation,” to use Amgen’s language), had become apparent.   

Prolia was marginally helpful, but other approaches might have been safer.  And worse, despite the problems with this drug, there seems to be no way to stop Prolia safely (and without moving to yet another drug with other serious problems).

Fractures were the worst but not the only problems associated with Prolia.  Problems involving needed dental care, urinary tract infections, skin problems and other matters were arguably attributable to Prolia as well.

MUCH OF THIS COULD HAVE BEEN AVOIDED.  Had Amgen’s patient information specified the hazards of  “delay” as opposed to a direction to “speak to your doctor before stopping Prolia,” (especially as  “stopping” this drug was not my intention at the time), and had my record been flagged  to have me come in for an injection on time even though a newly assigned doctor could not see me right away, these fractures and the resulting pain and disability might have been avoided.   

DEAR DOCTOR, WHAT CAN YOU DO?   With considerable personal effort and expense I am slowly improving, but recovery may never be complete.  So to help others avoid what I have suffered, I offer these suggestions to spare your patients this nightmare: 

1.  Do not prescribe Prolia.  If there are safer ways to treat osteoporosis and prevent fractures please consider and recommend them.  

2.  Report Adverse Drug Reactions arguably associated with Prolia to the FDA. 

https://www.fda.gov/Safety/MedWatch/HowToReport/default.htm

Report to Amgen as well.   (800) 772-6436.  You do not need to prove causation to report suspected adverse drug reactions.

3.  When patients ask about Prolia (perhaps having seen Amgen’s TV ads), counsel them on the dark side of Prolia, and stress that once on it, there may be no safe way off.  Warn of dangers of delay, and other issues with Prolia. Too busy?  Consider the results when patients learn what I have learned so painfully, and prepare someone in your practice to counsel them.   

4. For patients now on Prolia, warn about the danger of delay, as this may not be clear from the tiny Amgen tab with their next shot date.  To assure this, flag patient records so staff will make sure patients are reminded to receive Prolia shots on time, and why!

5.  Warn patients, as graphically as possible, that what might have been a pleasant and productive part of their lives could be abruptly, painfully, expensively and permanently terminated if they do not get their Prolia shot on time.     

6. Feel free to share my blog. www.JoansBackboneDisaster.com.    

Consider adopting examples of warnings at http://www.joansbackbonedisaster.com/2018/09/trying-to-warn.html.

Patients may also find resources in this blog, including books and websites with information about osteoporosis and treatments in general.

7.  Identify safe protocols to exit Prolia.   Research is needed here!    

I would be grateful to learn whatever you know about this at  JoansBackboneDisaster@gmail.com.

8.  Identify rehabilitative resources for patients injured by Prolia.  If your institution cannot provide these, identify resources in your community (Medicare reimbursed where applicable).  

IF YOU WORK FOR AMGEN, ask yourself: Is Prolia a blockbuster or a bonebuster? 

Consider advocating for one or more of the following: 

1. Withdrawing Prolia from the market or marketing it only as a last resort for osteoporosis not treatable by safer means. 

2. Withdrawing television and other Direct to Consumer advertising for Prolia.

3.  Developing safe exit strategies for those already trapped in a Prolia regimen.         

   

4. Placing Black Box warnings about the danger of delay in all labeling, and highlighting warnings about “delay” (using this word) in patient information. 

I regret being unable to discuss this with you in person. I am still too disabled to travel.  But I hope you will consider what I have written here. No one deserves to have an active life destroyed so unnecessarily or so painfully as mine has been.

You may reach me by email at: JoansBackboneDisaster@gmail.com, or via the comment box at www.JoansBackboneDisaster.com.

Cordially,    Joan Levin,  Chicago