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.