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.