IT WASN'T JUST ME!

A friend sent me a video about healing from compression fractures.

Here is a link to it.   https://www.youtube.com/watch?v=ErvLU4ETuOo

It was produced by author Margaret Martin of Melioguide https://melioguide.com, a website devoted to osteoporosis, etc., but this was a video on YouTube.

For me the most remarkable part of the video came in the first few seconds with some background about a woman who had been on Prolia for some time, was taken off it by her doctor, and who, shortly thereafter, suffered painful vertebral compression fractures.

The rest of the video is an account of her long, painful and not very complete rehabilitation. This was very hard for me to watch emotionally, being in the same situation right now.  But it's out there!

Also looking at a social media website called "Health Unlocked" (https://healthunlocked.com) where people tell personal stories about their medical experiences.  Tons of comments of horrible experiences with Prolia that I wish I'd seen years ago!  

POSTSCRIPT: I added my own comment there under my screen name "Viazoy" on September 3, 2018 which appears at: https://healthunlocked.com/bonehealth/posts/138831345/an-unnecessary-disaster-from-prolia.

And also see this in another section at Health Unlocked at: https://healthunlocked.com/american-bone-health/posts/139191460/getting-off-prolia?uid=a9561e0e-cc12-4d8f-a432-46940159b283&utm_campaign=american-bone-health&utm_medium=email&utm_source=notification&utm_term=new-daily+digest .

(Health Unlocked has two relevant bone "communities:"  Bone Health and American Bone Health.  Since the difference is not clear to me I post at both)


AND THERE'S MORE!   Since I started sharing my experience, I've been hearing from friends my age (including two former high school classmates!) currently on Prolia who knew NOTHING about the hazards of even short delay.  One was about to take a trip abroad and delay her shot!  I hope she could benefit from my experience! 

When will there be appropriate warnings for doctors and patients?  Clearly I can't be the only voice to do this?

How many more older women will have a chunk of their remaining lives ripped out from under them because Amgen does not add these three little words (or words to this effect) to it's Prolia labeling: "... Or Brief Delay?"   How many will suffer pain and deformity -- perhaps permanently -- because the medical facility administering their shots didn't properly warn them?

PROGRESS NOTE: AN ACHIEVEMENT AND A SETBACK

July 18 was a day of a great achievement and something of a setback.

The achievement came in the morning when I was able to take the bus that stops in front of my house for the first time in almost five months to finish some half-done dental work.  I felt a little unsteady but I got a seat and between a smooth driver, my cane for balance, and firm supportive seats, I was ok.

A friend seated nearby asked what happened to me.  I answered so others could hear too.

It's one more way to get the word out about Prolia's hazards.

At the dentist though, I was really hurting from being upright for so long, and was grateful for that dental chair where I could lie almost flat on my back, and soon I felt better.  

I even took the bus home, and didn't feel guilty about sitting in the  elderly and handicapped section.  (I hope my greying hair and the cane established my bona fides!)

But once home I was hurting a lot and glad to fall asleep flat on my bed, exhausted. But being able to take the bus downtown was a great achievement and saves cab fare as well when I can do it.

The setback came later in the day.

I was so encouraged by my triumph of the morning that I thought I could actually attend Rosita Arvigo's last nature walk for this summer to be held in Lincoln Park, not far from my home and near my bus line.  I had missed this, along with so many of my other favorite summer activities.

(if you would like to learn more about Rosita Arvigo and why I was so hopeful that I could make her last Chicago nature walk for this summer, please see https://rositaarvigo.com.  If you live in the Chicago area and would like to learn more about these wonderful summer nature walks, you may contact her at https://rositaarvigo.com/about-dr-arvigo/contact-rosita/.)

I started out fairly well, but as we slowly walked along, learning about the edible and medicinal qualities of ordinary local wild plants, the crushing pain under my ribs and around my mid-section grew steadily.   I took some weight off my body with my cane until my shoulders ached, and I didn't think I could make the two block walk back to a bus stop.

Luckily a friend was kind enough to run me home.  I got into bed and once the pain subsided I slept soundly until late the next morning.

So while I had the morning's great achievement of taking a bus and having long-delayed dental work done, and even attending part of Rosita's walk, it's clear that my activities are still going to be very limited - for how long I don't know.

WHAT AMGEN SENT ME

What Amgen Sent Me

Amgen has sent me over the past several weeks lots of their professional literature, including their "labeling" as it is called.  It warns against "stopping" Prolia, and urges consulting with a physician before doing so, but nowhere does the word "delay" appear.  While "stopping" could include "delay," most lay people reading this (and perhaps medical professionals as well) might not think of a brief "delay" (for whatever reason) as going off a drug permanently.  And in my case the delay was in large part occasioned by the prescribing doctors.     

Amgen's representative with whom I spoke on the phone asked if I had seen their patient information.  I said I had not.  So they sent me a beautiful brochure printed in full color on heavy, glossy stock.  It was all in Spanish.  I can read Spanish fairly well but saw nothing warning patients of delay.  So to be fair I called back and asked if I could have a copy in English.

When that arrived,  a quick reading confirmed that this -- like its Spanish language counterpart -- was mostly a puff-piece about the wonders of Prolia.  There was no mention of the disaster that could result from even a short delay.  In fact, as with their literature for doctors, the word "delay" appeared nowhere that I could see.    

I also got a nice letter from Amgen urging me to suggest to my doctor that this brochure be given to patients.   I responded that I would specifically recommend to my doctor that it NOT be given to patients because it had omitted the very information that could have spared me many months of pain and disability so far, and prospects of the same looking forward.   

AMGEN'S LAWYER CALLS ME

Around this time I received a call from a woman identifying herself as a lawyer for Amgen.  

Perhaps she was calling to find out how I was doing or to help me find help for rehabilitation.  

But no, as it turned out her purpose was to instruct me to stop my weekly or bi-weekly "progress report" calls to Amgen's information number (800-772-6436 -- that's 800-77AMGEN).

These calls to Amgen are generally taken by a nurse.  I call to let Amgen know how I'm progressing in my efforts at rehabilitation and to seek any suggestions about how to get better.  Besides reporting on my own progress, I also inquire as to what progress they might be making in getting warnings concerning delay on Prolia labeling, or suggestions about getting off Prolia safely.   

But today the Amgen lawyer -- who actually seemed personable --  instructed me that I was not to call Amgen but to call her instead.  I politely asked if she was medically trained as well as legally trained to give me advice on my rehabilitation.  Apparently she was not.  So I have since called Amgen again.

I also thought the folks at Amgen might have appreciated my concern that their product carry accurate information.   
Apparently this was not the case.

PROGRESS NOTE: A DAY IN MY LIFE - TIRED AND VERY SAD

Progress Note:

This was one of those days when I felt tired, sad and even hopeless.

I tried to do some food prep today to make mealtimes easier, and I also did my exercises the physical therapist recommended to build my core, give me more stability and straighten the spinal curvature that has resulted from this Prolia disaster.   But I see that I still have pretty tight limits on what I can do in a day -- a far cry from a few months ago!

At risk of overdramatizing, today I felt like the incredibly moving last line of Robert Falcon Scott's epic account of his final and ultimately fatal Antarctic expedition where he wrote:  "It seems a pity, but I do not think I can write more."    www.tinyurl.com/ScottsLastEntry:
 
I need to rest a lot but I also need to do my rehabilitation exercises.  So I keep plugging away.

I am so grateful for friends who visit, and I try to keep that smile on my face,  but today I miss my life so much.   I want to be the visitor, not the visitee!  I want to be the one who helps, not the helped.

I guess I'm grieving for my former self and wondering how much I can bring back.

And always that maddening thought -- I know I'm being repetitive here -- that all of this was so easily preventable.  JUST A FEW WORDS in Amgen's patient and doctor information about the dangers of even a short DELAY in that six-month Prolia schedule, and all of this likely could have been avoided!

I need to take a nap now.  This has been an exhausting day.

A Day of Pain

ORGANIC CONSUMERS ORGANIZATION'S SENSIBLE SUGGESTIONS

Organic Consumers Association published this article in May,  2016, after I'd already been on Prolia for a few years.  I've often found OCA's articles well-researched and useful.  Perhaps if I'd seen this earlier I'd have thought twice about starting Prolia.    

Please note - the link immediately below is the BEST WAY to read this article and open links in it.  But as a convenience I've pasted the full text below.  The remainder of this page is a copy of that article. 

Once again, please note, any information you decide to adopt for yourself should be discussed with your own qualified health care provider.

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

https://www.organicconsumers.org/essays/big-food-and-big-pharmas-campaigns-sell-fear-thinning-bones—and-dangerous-products

Big Food and Big Pharma's Campaigns to Sell Fear of Thinning Bones—And Dangerous Products May 26, 2016 Organic Consumers Association by Martha Rosenberg

If you’re worried about thinning bones, or bone fractures, you probably have Big Food and Big Pharma to thank for keeping

you up at night.  For decades, these two industries have used scare tactics to convince the general population that they’re bones are at risk— and that they, and they alone, have the answers to your thinning bone problems.

But the healthy bone “solutions” peddled by Big Food and Big Pharma have in most cases proven healthier for corporate

profits, than for consumers’ bones. And some of those “solutions” have actually contributed to thinning bones.

‘Milking’ consumer fear 

Almost 20 years ago, the dairy industry announced a fictitious “calcium crisis” caused by too many young people drinking beverages other than milk. In addition to rolling out new bottles that made milk drinking seem “fun,” the dairy industry launched its “Milk: It Does a Body Good” campaign that told teens and tweens they should drink milk now to prevent osteoporosis in later life.

There were two obvious problems with the “Milk: It Does a Body Good” campaign. First, 12-year-olds don’t worry about the condition their bones will be when they are 58 years old. And second, milk is neither the best or only source of calcium. But the marketing geniuses behind the campaign didn’t let a few inconvenient facts get in the way. They forged ahead, undaunted.

Meanwhile, even though milk sales were falling, cows were being “culled” to keep prices up, and the government was buying up the milk surplus no one wanted, Monsanto in the 1990s was busy at work developing recombinant bovine growth hormone (rBGH) which let dairy operations get seven to 14 additional pounds of milk daily out of a single cow.

It wasn’t long before questions arose about the fate of an rBGH by-product called Insulin-like growth factor 1 or IGF-1 in the human body. As reported in the New York Times, male rats developed cysts on their thyroid glands and abnormalities on their prostates. But that didn’t stop Donna Shalala, then-secretary of the Health and Human Services Department, from refusing a request by Senators to investigate whether or not the U.S. Food & Drug Administration (FDA) had overlooked rBGH safety evidence.

Shalala even went so far as to help kick off the National Dairy Council and the National Osteoporosis Foundation's national

"milk mobile" which toured 100 cities, offering free bone density screenings and a chance to be in a milk mustache ad. Shalala herself posed in a milk mustache ad.

Bone drugs a ‘bone-anza’ for Big Pharma

Big Pharma has done an even better job of instilling, in women especially, a fear of bone loss in order to sell pharmaceutical products.

When hormone replacement therapy (HRT) proved to be a 40-year scam (causing the very same symptoms it was supposed to prevent), Big Pharma rolled out a “thinning bones” campaign to retain the same women customers. Watch out, the drug companies told women—your bones are probably thinning and soon you will have fractures, a stooped posture and worst of all, you’ll “look old.”

Soon, just as model Lauren Hutton had sold HRT, Meredith Vieira from the Today show, former Charlie’s Angel Cheryl Ladd and actress Sally Field were selling bone drugs.

But it was the bisphosphonate class of drugs—Fosamax, Boniva, Actonel and Reclast—that proved to be the real “bone-anza” for Big Pharma. By stopping the body’s natural process of bone remodeling—in which mature bone tissue is removed from the skeleton through resorption and new bone tissue is formed—these drugs appeared to prevent osteoporosis or thinning bones.

The operative word being “appeared.”

Soon after their approval, bisphosphonates were linked to serious side effect, including heart problems, intractable pain, jawbone death, esophageal cancer and the very fractures they were supposed to prevent. Many wondered why the drugs were approved. For example, if patients did not sit upright after taking a bisphosphonate, they could end up in the ER with esophageal damage.  And the disfiguring side effect of jawbone death sometimes required a tracheostomy (an incision in the windpipe), bone grafts and even jaw removal.  So much for staying young and pretty.

Drug companies knew, but didn’t tell

Court documents show that Merck, who made the popular bisphosphonate Fosamax, knew about jawbone death since the 1970s but marketed the drug anyway. In fact, it was dentists, not the FDA or Big Pharma who first reported the problem. In 2013, Merck agreed to pay $27.7 million for multiple Fosamax lawsuits.

In 2013, I interviewed Dr. William Banks Hinshaw, a gynecologist and chemist in North Carolina about the emerging side effects of the popular bone drugs. He told me:

“One hundred and fifty years ago, people who worked around white phosphorus in factories where matches were made

in the U.S. and Europe sometimes developed "phossy jaw" (osteonecrosis) and thigh bone fragility similar to

bisphosphonate effects we see today. The chemical culprit is likely to have been a substance in the white phosphorus

smoke that inhibits an enzyme involved in the process of bone remodeling and bisphosphonates happen to have been

innocently developed as synthetic versions of that substance. I have researched this extensively, including U.S. Army

reports about white phosphorus smoke which was shown to include large amounts of the same substance.” 

In addition to knowing about the side effect of jawbone death for years, Big Pharma must have known about the likelihood of

fractures in people taking the bone drugs too because they were well reported in medical journals. “We report atypical skeletal fragility in three subjects after long-term, combined anti-remodeling therapy,” said the authors of a 2008 Journal of Clinical Endocrinology & Metabolism study. “An Emerging Pattern Of Subtrochanteric Stress Fractures: A Long-Term Complication Of Alendronate [Fosamax] Therapy?” read the headline of an article that appeared in Injury the same year. 

And this from the Journal of Orthopedic Trauma: “Low-Energy Femoral Shaft Fractures Associated With Alendronate Use.”

How could such drugs with clear and expected dangers become bestsellers I asked Dr. Hinshaw. “The enthusiastic industrial support of the clinical trials has created a cadre of dedicated bisphosphonate supporters, convinced that the presumed benefits outweigh any possible risk,” he told me.

The "industrial supporters" were no doubt also helped by a sneaky scheme concocted by Fosamax-maker Merck. It hired the consulting firm of former drug researcher Jeremy Allen to whip up fears of osteopenia—the risk of getting osteoporosis—by placing bone density–measuring machines, machines that had barely existed until then, in medical offices across the country.

According to National Public Radio, Allen also created the faux “Bone Measurement Institute” to establish “osteopenia” as a health epidemic. He even pushed through the Bone Mass Measurement Act which transferred the cost of bone scans to onto Medicare.

Yes, taxpayers ended up paying for scans for a largely made-up condition. All for the enrichment of Big Pharma.

Along comes an ‘unBisphosphonate’ just as bad as its predecessor.

As many Pharma watchers know, genetically engineered biologic drugs that are liquids not pills (think Humira, Remicide and Xolair) are the new pharmaceutical profit center. So when an injectable drug to treat thinning bones, the biologic Prolia, was approved in 2010, Wall Street and Pharma had high hopes.

Not only do biologics bring in as much as $20,000 per patient per year, it was hoped that Prolia would lack the serious side

effects of bisphosphonates.

But two years after its approval, Prolia’s maker Amgen issues a warning that included bisphosphonates' risks and more. Prolia could cause "hypocalcemia, serious infections, suppression of bone turnover, including osteonecrosis of the jaw” as well as “atypical femoral fracture” and “dermatologic adverse events," warned Amgen.

Clearly Prolia was the same old wine in a different "syringe."

As with bisphosphates, Prolia’s action could easily have been predicted. According to transcripts from FDA hearings, monkeys 

developed tooth and jaw abscesses on the drug, and human subjects developed cervical, ovarian, pancreatic, gastric and

thyroid cancers. During trials, 10 people were hospitalized with the skin infection cellulitis, and one died.  Breast cancer, according to the transcripts, was the "most common adverse event that led to discontinuation" in trials. 

Breast cancer a mere “adverse event?” Tell that to the women who endured chemotherapy—and the families of those who died.

Like most of Pharma’s new biologics, Prolia compromised the immune system and invited opportunistic infections. But though FDA clinical reviewer Adrienne Rothstein, M.D. stated during hearings that Prolia "has the potential to affect multiple layers of the immune system" and that "three subjects required hospitalization for pneumonia after a single dose,” the FDA approved Prolia two months earlier than expected.

Amgen deployed 1,000 reps to sell the drug which is still being marketed.

Ask your doctor . . .

As anyone who follows pharmaceutical marketing knows, direct-to-consumer advertising has created blockbuster drugs

through selling and redefining diseases so that more patients take more drugs for a longer time.

For example, depression was once a self-limiting condition not a ailment that requires life-long drugs and add-on drugs as it is portrayed now. And Gastroesophageal Reflux Disease or GERD, while it does exist, has been whipped up by Big Pharma as a common ailment in order to sell expensive drugs called Proton Pump Inhibitors (PPIs) like Prilosec, Prevacid, Nexium and Protonix. Usually what passes for “GERD” is just heartburn that can be treated with TUMS or Maalox, or something as simple as eating less.

Convincing people they have depression or GERD is not just a question of marketing expensive drugs they may not need. 

Both of the drugs prescribed for these conditions are highly linked to bone thinning!

“Patients with gastroesophageal reflux disease (GERD) receive long-term therapy with proton pump inhibitor (PPI) agents.

Several studies have recently been published suggesting that treatment with PPI may cause bone fractures,” according to a 2013 in Rheumatology International. The FDA agreed. A review of several epidemiological studies found an “increased risk of fractures of the hip, wrist, and spine with proton pump inhibitor use,” the agency said in 2011.

The aggressively marketed antidepressants called SSRIs, including Celexa, Paxil, Prozac and Zoloft, are also linked to

fractures say journal articles. SSRIs “may increase the risk of bone fractures, according to new research, reported Medical

News Today, citing an article in BMJ Injury Prevention. WebMD agreed. "SSRIs appear to increase fracture risk among middle aged women," it wrote, citing research in the journal Injury Prevention that appeared last year.

Keeping bones strong

While osteoporosis and related bone conditions certainly exist and do sometimes require treatment, fear of “thinning bones” and “osteopenia” is largely an industry concoction to sell products. Evidence strongly suggests that bisphosphonates and Prolia can make bones weaker (as can GERD and depression meds)— but so can the high-saturated fat, low-fiber Western diet that Big Food pushes. In fact, people in poorer countries where milk is not consumed often have lower fracture rates than the U.S. notes T. Colin Campbell, PhD, in The China Study, debunking the

idea of "milk deficiencies."

According to an article in the American Journal of Clinical Nutrition, “Elderly women with a high dietary ratio of animal to

vegetable protein intake have more rapid femoral neck bone loss and a greater risk of hip fracture than do those with a low ratio.”

The best way to avoid thinning bones, says Consumer Reports, is to follow the advice doctors and nutritionists gave long before “milk deficiencies” were identified and bisphosphonates existed. Get busy with weight-bearing aerobic activities like walking, dancing and yoga. And eat a nutritious diet. In some cases, it may make sense to take calcium supplements, but beware—not all calcium supplements are created equal and careful attention should be paid to taking calcium and vitamin supplements in the right combination, as noted in this  article on Mercola.com. 

More here on how calcium taken with Vitamins

D and K2 provide the best balance of bone health-supporting nutrients.

Martha Rosenberg is a contributing writer to the Organic Consumers Association.

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PROLIA'S APPROVAL TIMELINE

Here for reference are some of the key dates in Prolia's FDA Approval Process:

Development History and FDA Approval Process for Prolia

Date	Article
May 21, 2018	FDA Approves Prolia (denosumab) for Glucocorticoid-Induced Osteoporosis
Sep 21, 2012	FDA Approves New Indication For Prolia (Denosumab) For The Treatment Of Bone Loss In Men With Osteoporosis At High Risk For Fracture
Sep 19, 2011	FDA Approves New Indications for Prolia (denosumab) for the Treatment of Bone Loss in Patients With Prostate or Breast Cancer Undergoing Hormone Ablation Therapy
Jun  1, 2010	FDA Approves Amgen's Prolia (Denosumab) for Treatment of Postmenopausal Women With Osteoporosis at High Risk for Fracture
May 17, 2010	Amgen Submits Denosumab Biologics License Application to FDA for the Reduction of Skeletal Related Events in Cancer Patients
Oct 21, 2009	Amgen Provides Update on Status of Prolia (denosumab) Biologics License Application (BLA) Submitted to the U.S. Food and Drug Administration (FDA)
Aug 14, 2009	Amgen Issues Statement on Outcomes of Advisory Committee for Reproductive Health Drugs (ACRHD) Meeting
Feb 18, 2009	FDA Accepts Amgen's Submission and Files Biologics License Application for Denosumab
Dec 22, 2008	Amgen Submits Biologics License Application for FDA Approval of Denosumab in Women With Postmenopausal Osteoporosis and in Patients Undergoing Hormone Ablation for Either Prostate or Breast Cancer

https://www.drugs.com/history/prolia.html#:~:text=Prolia%20Approval%20History.%20FDA%20Approved%3A%20Yes%20%28First%20approved,form%3A%20Injection.%20Company%3A%20Amgen%20Inc.%20Treatment%20for%3A%20Osteoporosis.

PROGRESS NOTE: HELP, CONVENTIONAL AND ALTERNATIVE, TO PICK UP THE PIECES

Having been pretty much seduced and abandoned by Amgen and in many ways by the prescribers of Prolia as noted, I turned to other resources for help in getting my body back.

I value the advice of my internist, Dr. Terry Sullivan, immensely.  l let him know what I'm doing and value his suggestions and encouragement. Luckily he is not one of those M.D.s who rejects out of hand anything considered "alternative."  I appreciate this as I try to work out a rehabilitation plan of sorts on my own, especially since the vaunted "experts" who gave me the Prolia (as well as the folks at Amgen who manufacture Prolia) seem to have no idea about what to do now.  

This is important to me.  I don't want to spend the rest of my life as an Amgen/Prolia cripple and I want to explore every possible avenue of recovering some semblance of a normal life!

Other helpful professionals have also stepped into this painful void:

Dr. Maunak Rana at the University of Chicago Pain Management Clinic has been the one bright light at the U. of C.  I appreciate his help and concern more than I can say.  More on this elsewhere.

(Unfortunately another large university pain clinic seemed to have nothing to offer except surgery which I felt had little or no potential to help me and much potential to leave me in ever worse shape.) 

I've gotten much help from Dr. Anne Gordon at Chicago Chiropractic and her wonderful team, particularly Physical Therapist Dr. Sanjoy Roy.  Dr. Gordon has kept my body going for nearly 25 years and her team, and especially Dr. Roy, are central to my rehabilitation now.  

This physical therapist has, among other things, guided me through exercises to help me strengthen my core to achieve more stability, and other exercises to relieve the spinal curvature associated with this Prolia disaster.  I appreciate them no end.

I also received much help when pain and inflammation were at their worst from a fine massage therapist, Seyda Tarabus.  

All of these have helped me. Of course this improvement, such as it is, could have been due to time alone, and I have no "control" for comparative purposes.  But bottom line: I can move around the house, I can get my own food, I can put on clothes and even tie my shoes and go for a short walk and enjoy friends who come over.

All of this was nearly impossible for the first two months of this disaster.

I still cannot do many things I would like to do, such as go out for a meal, or a movie, or even a long walk, or a drive during this all-too-short Chicago summer without a degree of pain.   I especially miss the wonderful summer get-togethers with friends that I enjoy so much.   I miss these terribly.  But I am grateful for what I can do now.

PROGRESS NOTE: THE FIRST TWO MONTHS

Progress Note: 

This is mostly a rant about two months of terrific pain and disability.

March and April of 2018 were terrible.  No other way to put it.  Anything other than lying flat on my back in bed hurt.  If I had to go out -- mainly to keep doctor appointments -- I had "Tylenol #3" with codeine from my internist, and that helped a little.  But since it was also terribly constipating -- another source of pain -- I only used it for these painful doctor visits. I was afraid to try anything stronger that would interfere with my cognition or be more addictive.

I found two meal services that delivered reasonably healthful meals in what I would call upscale MRE's that I could eat right from their packages.   I would hobble to the kitchen and bring one back to bed to eat without heating, lying flat on my back.

Lying perfectly still, flat on my back, was the only comfortable position I could find, I was grateful to have that!

The simplest self-care tasks such as going to the bathroom or brushing my teeth were hellish.   Tying my shoes was nearly impossible.  To go to medical appointments I wore slip-on shoes that frightened me to wear as I was afraid of falling.

Luckily my condo building has a wonderful staff, and, armed with an iPad Mini with a hand strap that I could use while flat on my  back, I could use Amazon and Instacart (an online grocery service)  for filling daily needs, and someone from the building would put these food boxes in my apartment.  And luckily as well, my medical appointments entailed reasonably short taxi rides (although getting in and out of cars was very painful.)

I engaged help three hours a week for light housekeeping including vacuuming, changing bed sheets and doing laundry in the building washing machines, tasks I normally did myself but could no longer manage.  Bending or lifting more than about 10 lbs. was out of the question.

In an effort to avert further bone loss as much as I could, I exercised for about 20 minutes daily by marching around the living room to Sousa marches before falling aching exhausted into bed for the rest of the day.

(Eventually I was able to get out a little to get more professional help with an exercise program to be described later.  Neither the U. of C. prescribing doctor nor Amgen had anything to offer in this regard, however.)

Spring was in full bloom, and after a few weeks I went for a  short daily walk with the cane that had belonged to my mother.  Using a cane helped with curbs and rough places in the pavement and, since I could not walk very fast, signaled to cars at stop streets as well.

As to clothing, anything that touched my now swollen and very tender mid-section hurt, so at home I mostly wore a nightgown.  Dressing was painful but to go outdoors or make painful medical visits I needed something more.

None of my clothes worked.  As noted, anything around my mid-section hurt like hell.  Also, I found I needed some support if I were to be sitting or standing for more than a few minutes.   My body shape had changed drastically.  I looked like an 81 year old "Miracle Mom" with my remarkably large "baby belly" (which I later learned was from a combination of inflammation and also from my gut with no place else to go when my height decreased because of the vertebral compression fractures).  

Also, at least when going out, I was more comfortable with some support.  I ordered a few corsets from Amazon  - the kind intended for postpartum women - that helped somewhat in keeping my mid-section stable if I had to leave the house.  But these added to my already amplified girth.

My enlarged middle was noticeable even though I had lost nearly 20 pounds over the first few weeks of this situation.  I did not seem to be able to eat as much at one time, perhaps because I now had less interior space for my stomach.  Also, I quickly became breathless.  Perhaps this was from lack of activity, but also perhaps because my lung capacity may have decreased with my height.

So clothing became an issue for me!   First, I made a "maternity" T-Shirt for myself at Cafe Press with the words "Ask me about my Prolia Belly" and a downward pointing arrow.    (Even at this point I knew I needed to warn others, and indeed, this shirt started conversations!)

Next, at Amazon, I found inexpensive and comfortable "yoga pants" made of lightweight rayon with wide, softly elasticized mid sections that didn't bind and with elastic around the ankles so I wouldn't catch my feet and fall.

Topped with an extra large t-shirt such as my new "maternity" shirt I hoped I looked like I was on my way to a Yoga class.

Here I am "all suited up" for a visit to the doctor.  Note my crookedy shape. More about this later.


One doctor to whom I'd complained that I thought this shirt was defective answered "It isn't the shirt!"  And as this picture shows, it clearly wasn't!  As my bones healed, my slight spinal curvature had intensified greatly, and getting that under control was one of my goals in physical therapy as well.   So I'm working hard with a physical therapist to correct this as well as to strengthen my core.

I tried to hold on to my sense of humor as I shuttled between medical appointments.  This included Dr. B. at the U of C who gave me a Prolia injection immediately after the MRI showed the broken bones (after the cow had left the barn, in other words) and also ordered a DEXA screen (which actually might have looked improved since my fractured bones were more compressed), and also the pain clinic doctors, and some other medical professionals helping with what I hoped would be some kind of recovery.

Managing Pain

My medical visits included the Northwestern Pain Clinic (because my primary doc is at Northwestern) and the University of Chicago pain clinic (where the bone endocrinologist was).  Among the things each of these clinics discussed were one or more of the surgeries available to "augment" crushed vertebrae like mine by injecting them with cement.

It was a bit of a "Lady and Tiger" situation which I found frightening, because while these surgeries must be done before the bones heal, there is also a great likelihood that you will get equally good pain relief without these surgeries (although you will be shorter and perhaps misshapen).  On the other hand, the surgeries themselves  -- while they seem to help some people -- can also wind up leaving you in more pain.  So in my mind, at least, it was a "damned if you do, damned if you don't" situation.

My general inclination was to try to avoid surgery, especially surgery like this with a dicey track record and no possibility of reversing the damage if they if it did more harm than good.  

Therefore I was relieved when the U. of C. Pain Clinic doc (the only doc so far who had really examined my back carefully, inch by inch, as well as going over the actual MRI with me and calling for additional x-rays as well) told me that because of the location and characteristics of the pain I was experiencing, he did not believe any of these surgeries would be likely to help me anyway.

Like this Little Girl, I Didn't Want A Cement Balloon!

The U of C Pain Clinic doctor recommended doing whatever I could to strengthen my core, and I have been doing that with the help of the wonderful physical therapists at my chiropractor's office.

But for the most part I've had to rely on my own resources to fashion what I hope will be a good rehabilitation program.     Unlike the signs in antique china shops, the adage "you break it, you bought it" did not apply to either Amgen or the U. of C. in this case! 

Nothing More from Conventional Medicine

In fact - beyond these surgeries - neither the U. of C. nor Northwestern had anything more to offer.

I'll leave for another post the question as to whether or not to continue on Prolia or another drug for osteoporosis -- but it was clear that for my healing process, now that I was nearly immobile and in a great deal of pain much the time, I would almost totally on why own as far as conventional medicine was concerned.

And having been thus seduced and abandoned, as noted earlier, I turned to alternative resources to be discussed in forthcoming posts.

PROGRESS NOTE: SEDUCED AND ABANDONED

When I got the results from the MRI (referenced in an earlier post) showing these three recent vertebral compression fractures,  I was in terrific pain.  Even moving around in bed to reach something on a bedside table was terribly painful.  Finding a comfortable position to sleep was almost impossible and my sleep suffered greatly.  

Driving my car was out of the question during those early months, and even getting into a cab to go downtown to see the doctors was terribly painful.  In fact, I did not have a minute without pain unless I lay motionless, flat on my back.  

What it Looks Like

Seeking Help from the Prescribing Physician. 

I kept in touch with Dr. B. at the University of Chicago (U. of C.) and saw her as well.  I thought that two things that could help me would be diet and exercise.  Being post-menopausal, while exercise could help, I believed that the main function of diet would be less about building bone density and more about maintaining blood levels of nutrients needed for normal bodily functions (including but by no means limited to calcium and vitamin D) for many reasons, including preventing minerals from being extracted from bones.   

Dr. B. sent me a list of foods with calcium, most of which were dairy based.  Perhaps this was to counteract the effects of Prolia, but I'm not sure.  However, I'm allergic to casein, a protein in milk products (and I always state this allergy, along with gluten, on all medical forms I'm given to fill out), and there wasn't much about other calcium sources.  

There was nothing about other nutrients besides calcium needed for strong bones.  So I asked if there might be a clinical nutritionist at the U. of C. to advise.  But no one seemed to have that information either.  (I later learned that there might be this resource at the U. of C. but at the time I most needed it the doctor involved did not seem to know about it.)

I also understood that while the right kind of exercise could help increase bone density (and had worked with a trainer for this reason for many years) I also knew that the wrong kinds of exercise -- especially ones involving flexing the back such as "crunches" -- could further stress my compromised bones enough to cause more fractures.  So I asked if there was a physical therapist at the U. of C. who could help me restore some of my strength, consistent with these issues.  No one could tell me that either; just that there "might be a P.T. on 53rd Street." (Turns out that perhaps there is, but by that time I'd found an extremely skilled and helpful P.T. through my long time Chiropractor, Dr. Anne Gordon.) 

Seeking help from Amgen, the Manufacturer of Prolia.

Next I called Amgen, the manufacturer of Prolia, again to see if they could offer rehabilitation advice -- especially about diet and exercise -- for incidents of this sort involving their drug.  They couldn't.  They simply told me to consult my own physician.  I have called them every few weeks to let them know of my progress and to see what progress they are making with getting the FDA to approve warnings about delay on Prolia.   I also ask if they have developed any kind of protocol for individuals in my situation.  Again, they have no useful answers for either of these questions.

(Post Script: All Amgen has done, as mentioned in another post, has been to have their lawyer call me to instruct me to stop calling them, an instruction I've ignored.)

Seduced and Abandoned.

Having been seduced into using Prolia, I definitely felt abandoned by what came next.  While both Amgen and the U. of C. were quick to provide this drug, neither, in my view adequately warned of the dangers of even a short delay, and, in the case of the U. of C., failed to handle the change in doctors appropriately.  And then, when disaster struck, both Amgen and the U. of C. left me on my own to deal with the painful and disabling consequences.   

I should add that Dr. B. at the U. of C. ordered many tests, all of which I had done, but while they are all recorded in My Chart it appears they offered no clear answers. 

The most helpful service at the University of Chicago as I tried to recover some shred of my life again was their Pain Management Clinic where I saw Dr. Rana. I continue to see him from time to time to this day and he continues to give practical advice, encouragement and badly needed doses of human kindness as I struggle to get better.  

Dr. Rana has also helped me sidestep some potentially dangerous treatments (such as kyphoplasty surgery -- which he does) that would not be useful (and could even be harmful) for me.
  
http://www.joansbackbonedisaster.com/2018/07/alternative-help-to-pick-up-pieces.html) 

Footnote: Patient's Fault?

"You should have known," you might be thinking.  "Surely there were warnings!"

Perhaps more on this later, but for now,  just know that for the six years or so that I was on Prolia I went to the U. of C. like clockwork, never missing an appointment.  As noted in an earlier post, there were either 1, 2, or 3 elements in each of these appointments -- the Prolia injection, the visit with the doctor and the DEXA scan.

While technically each of these elements might have been a separate appointment, I had become accustomed to regarding them as one event with three components.  Indeed, they were treated as such by the U. of C.,  and I received just one "reminder" call from the U. of C. for for these.  So my treating these three elements (Prolia shot, DEXA scan and doctor visit) Prolia shot as one appointment when they were scheduled together was reasonable and understandable.  

Therefore, when Dr. A. was no longer there, and when there was a delay of several weeks in seeing Dr. B., (as noted in an earlier post) I believe I should have been reminded that I should still come in for my Prolia injection, even though there my previous doctor was no longer there and there would be a delay in seeing the new one.    

Also, had a strong warning about the consequences of delay been given to me with each Prolia shot (instead of just a little tab with the next appointment date), this too might have caused me to insist much more forcibly that even though there was no doctor to see me, I should come in just for the Prolia shot.  

(Knowing what I know now, I might even have gone to court seeking emergency injunctive relief to require the U. of C. to give me this injection on time!) 

 In my opinion, such a warning should also have been part of Amgen's labeling for patients. 

Could this all have been Avoided?

I asked Dr. B. why records could not be flagged for patients on Prolia to make sure that their shots were not delayed in case an appointment had to be delayed either because of the doctors or the patients.  At first Dr. B. said that schedulers could not keep track of things like this.   I responded that my record was flagged so that schedulers knew that I was on Medicare and that therefore my appointments couldn't just be six months apart; they had to be six months and five days apart. 

This left me wondering how many other patients were caught up in the same situation when Dr. A. left but I have no way of knowing, or knowing if anyone warned them.

But the fact remains:  both Amgen and the U. of C. were happy to have me come in for expensive Prolia injections, but when -- largely as a result of failure to warn -- disaster struck, neither had any real help to offer, and I was left almost totally on my own resources to deal with the long-lasting pain and disability.  

Truly, I felt seduced and abandoned!

(Later, as noted at http://www.joansbackbonedisaster.com/2018/09/trying-to-warn.html, Dr. B. tried to remedy this failure to warn situation to some extent, but I believe far more stringent methods are in order, and that Amgen should bear some responsibility for this, for warning patients specifically about the danger of delay.) 

###

GETTING STARTED WITH A NEW DRUG, THEN A SHORT DELAY, AND THEN -- DISASTER!

I had been fighting osteoporosis for a long time, but despite carefully following the prescribed diet, exercise regimen, and (for a short while) some other prescription drugs, my DEXA scores (the test used to measure bone density) kept falling.

I'm a non-smoker, an almost totally abstemious drinker, a huge consumer of fresh fruits and vegetables including those high in calcium and other bone-building nutrients, and a moderate consumer of fish (especially salmon with bones) and occasional eggs.  I'm a big city walker and for years have worked regularly with a trainer with heavy weights, which I don't particularly enjoy but which I have done primarily to maintain bone density.   Because of allergies I'm gluten- and casein-free.

Around 2012 I consulted a bone endocrinologist, Dr. A* at the medical center of the University of Chicago (U. of C.).  The U. of C. prides itself on being on the front line of medicine.

Dr. A.*, suggested trying Prolia.  This drug had not been on the market long.  In fact it had only been approved by the FDA about two years earlier,  and that should have been a red flag right away.

You can read about this history in this blog at:  http://www.joansbackbonedisaster.com/2020/07/prolias-approval-timeline.html


I do not think it is a good idea to take a new drug until at least five years following FDA approval.  This is because the number of people tested in pre-marketing clinical trials is much lower than the number who may be taking it when it is on the market, especially when it is heavily promoted,  so larger numbers of adverse effects may not show up than in the earlier testing phases.  

But I was frightened, and at that point I even trusted the doctor, so despite my general aversion to pharmaceuticals --  especially newer ones -- and mostly out of desperation as I watched my DEXA scores tumble, and with growing fears of disabling fractures and no other solution in sight, I decided to try it.

Prolia is administered by injection very six months.  So every six months like clockwork I went to the University of Chicago Hyde Park campus for an injection.  Once a year, on that same day I would also see Dr. A.*  And every two years, also on the same day, I would have a DEXA scan.

I kept these appointments faithfully.  While technically the doctor visit, the Prolia shot and the DEXA scan were three separate appointments, I always saw them as one appointment when I went to the U of C., and they were treated as such by the reminder calls I received.   On my day to go there for one, two or all three of these things, I just went for whatever was on the menu for that day, and was always present on time for these appointments.

A Delay 

Shortly before my appointment was scheduled for January 22, 2018, the U. of C. called to say that Dr. A. could not be there and I should come back two weeks later.  So I wrote the new date on my calendar.

But just before that new date, the U of C called to say that Dr. A. would not be returning, and I would see another doctor, Dr. B.*  Dr. B. did not have an open appointment until the end of May so I put that new date on my calendar.

I SPECIFICALLY ASKED ABOUT THE PROLIA SHOT THAT WOULD HAVE BEEN DUE ON JANUARY 22 ALONG WITH THE DEXA SCAN.    

THAT I HAD NEVER MISSED (OR BEEN LATE) FOR AN APPOINTMENT FOR THIS SHOT SUGGESTS THAT I TOOK THIS SERIOUSLY.  

I WAS TOLD THAT THIS TOO WOULD HAVE TO WAIT UNTIL I SAW THE NEW DOCTOR FOUR MONTHS LATER. 

HERE IS WHERE I MADE THE BIGGEST MISTAKE OF MY LIFE!   I ACTUALLY BELIEVED WHAT THEY TOLD ME!  I ACTUALLY THOUGHT THEY KNEW WHAT THEY WERE DOING!  

HOW WRONG I WAS!   

IT IS STAGGERING TO THINK THAT A WORLD FAMOUS MEDICAL INSTITUTION OF THE STATURE OF THE UNIVERSITY OF CHICAGO COULD NOT MANAGE A SIMPLE SCHEDULING TASK LIKE THIS!

--  THIS WAS AN INJECTION ADMINISTERED BY A NURSE!  --  NO DOCTOR WAS NEEDED! 
--- I HAD BEEN ON THIS DRUG FOR SIX YEARS! 
--- A PHONE CALL, A LETTER OR EVEN A POSTCARD SIMPLY SAYING: THE NEW DOCTOR CANNOT SEE YOU BUT YOU CAN COME IN FOR YOUR PROLIA SHOT  WOULD HAVE SUFFICED.  

I HAD DONE MY PART AND NOT MISSED A DATE FOR THIS IN SIX YEARS.    COULD IT BE THAT THE SAME UNIVERSITY OF CHICAGO THAT GAVE US THE ATOM BOMB COULD NOT EVEN MANAGE THIS?  

DISASTER!

During a vacation in late February 2018,  I began to experience severe back pain which I ascribed to handling heavy luggage and terrible plane seats.  Once home, it became a lot worse and, not thinking this was related to Prolia, I went to see my regular internist on March 14, 2018.

By this time the pain was excruciating and even the short trip downtown to see the doctor was unbelievably painful.  He sent me for an MRI which was also unbelievably painful.   It turned out I had new compression fractures in three vertebrae: T11, T12 and L3.  (Also, the MRI showed some some old compression fractures in L2, and L3 and endplate compression at T9 of which I had not been aware).  

The whole report said:
"VFA was visualized from T3 to L4 and showed fractures L4, L3, L2, T12, T11 and end plate compression at T9."

I immediately e-mailed the new bone endocrinologist at the University of Chicago,  Dr. B. (whom I had not yet seen) about this, who indicated that this was because I'd "stopped Prolia."  I replied that it had never been my intent to "stop Prolia" and Dr. B. said that recent literature showed even short delays in receiving these injections could entail fractures.**

This had never been explained to me, and we had some discussion about this.  The U. of C. already had my record flagged that I'm on Medicare so that their schedulers would have known that my expensive Prolia shots needed to be not just six months apart, but AT LEAST six months and five days apart to qualify for Medicare coverage.  So there seemed to me to be no reason why my record couldn't have also been flagged to make  schedulers aware of the danger of delay.   

So I finally received the Prolia shot that I should have been given on January 23, 2018 on March 16, 2018,  by which time my back had broken in three places!    

These fractures almost certainly occurred at some point during a trip I took in late February, shortly after University of Chicago had cancelled my scheduled Prolia shot because of the retirement of my doctor and before the new University of Chicago could see me.  

How easy it would have been for the University of Chicago to have said something to this effect:   "Dr. A. has retired and cannot see you, but you are regularly on this drug and a delay could mean fractures.  Please come in and a nurse will give you your Prolia shot and you can see the new doctor, Dr. B., as soon as she has a free hour for an appointment."  

Had this been done, had someone reached out to tell me that even though my former doctor was gone and the new doctor couldn't see me until months later in late May,  and that I should still come in for that Prolia injection even though I hadn't seen the new doctor yet,  all of this pain and disability would likely have been avoided.  

Similarly, an adequate warning by Amgen, Prolia's manufacturer,  about the danger of "delay" could have averted this disaster.  Amgen cautions patients: "speak to your doctor before stopping Prolia."  But I'd never considered "stopping" Prolia.  And, as noted above, it was "my doctors" who delayed my appointments.

In fact, at that time I could not find the word "delay" anywhere in Prolia's labeling for doctors or patient information.  While as noted elsewhere there are warnings against "discontinuation" I had no intention of stopping Prolia. 

I called Amgen and spoke to a nurse there who said she would send me material to read about Prolia.  I've called Amgen a number of times since and will say more about these interactions elsewhere, but suffice it here to say that I could find nothing about "delay" in any of the material they sent me.

While doctors might understand "discontinuation" to subsume "delay" I believe there is no excuse for failing to include the word "delay" in patient information intended for lay people. 

NOTE ADDED January, 2020: It pains and angers me to think that these past four years of pain, disability and expense, with no end in sight, could have been averted with just one word from a properly trained scheduling clerk when they informed me of the change in doctors.   

I could easily have come in for that January 2018 appointment and a nurse could have given me the shot.  I wouldn't even had to have seen a doctor!   Had there been a warning about DELAY in Amgen's literature at the time it also would have helped me make a stronger argument for this.   

What a shameful, dreadful, inexcusable waste of a reasonably healthy (albeit aging) body!  What a waste of a still productive life!  

I see that Amgen has now added the word "DELAY" in at least one of its patient advisories -- although not in a way most people would be likely to notice.  I'm glad they are at least doing this now.   

As you will see in these pages one of the doctors now hands out a warning about getting Prolia shots on time, but in my view this warning is totally inadequate.   

I am not aware of any changes made in record flagging or support staff training in this regard but I surely hope that this has been done.  One totally avoidable "accident" like mine is one too many!  

As this blog proceeds I'll update some of the things that I have dealt with over the following months of pain, disability and expensive rehabilitation.

Update: I am writing this paragraph on April 2, 2021.  I continue in pain.  Normal life is impossible.  It has been four years now and I cannot even remember what it is like to have a day without pain, let alone the pleasure of a mid-winter sunshine getaway!   

I still see Direct-to-Consumer advertising about Prolia on TV, and I watch these ads with horror, hoping that by now more people (and their doctors!) are aware of this drug's dirty little secret as I continue to deal with daily pain and disability because of a simple failure to give adequate warning about the hugely destructive potential of this drug!  

-------------------------

*Note that while I am not naming the U. of C. physicians involved in this debacle, and while I believe that much of the harm I incurred was because of Amgen's failure to include specific warnings about the danger of delay, especially in its literature for patients, as well as the University of Chicago's failure to have a system in place to warn patients about this as well, I wish Dr. A and Dr. B had each played a more proactive role in preventing this painful fall through the cracks resulting from the U. of C.'s internal personnel changes.

** In future posts I hope to offer more information about fractures occurring after such delays, including information published in the medical literature before my fractures occurred, but for now suffice it to say that they DID occur and were almost certainly related to this short delay, occasioned by what I would call a manufacturer's failure to warn coupled with a totally avoidable medical clerical error by the U. of C.