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?