"Health Unlocked" is what I would call "Medical Social Media" This website invites health care consumers to share their experiences. I'm not sure who vets the posts, but it may be useful to see what others are asking and experiencing. Again, anything here you are thinking of adopting for yourself should be checked with your own qualified health care provider. Health Unlocked https://healthunlocked.com appears to originate in the UK. I cannot tell for sure, nor can I tell whether or how these posts are medically vetted. But it's an interesting site, and many posts ring true with my own unhappy experience with Prolia. (It references being part of the National Osteoporosis Society which comes up in this Wikipedia article on the Royal Osteoporosis society: https://en.wikipedia.org/wiki/Royal_Osteoporosis_Society#The_Duchess_of_Cornwall_Award If this is not correct attribution I'll change it as soon as I can find the necessary information.)
I wrote this for a medical meeting my doctor will attend this month, and am reprinting it here for your convenience. I don't expect my doctor used it but here it is!
Dear Doctor, March, 2019
You may have recently viewed a scan of vertebral compression fractures at T11, T12 and L3 associated with a delay in receiving Prolia (denosumab, Amgen). Those
bones could be mine. Before these fractures I was “81 going on 60.” Retired, I was active with family, friends, organizations and travel. Now I am “82 going on 160,” in
daily pain and limited in activity. This might have been averted had Amgen warned of the danger of even short delays in administering its osteoporosis drug Prolia.
After a year, with time, physical therapy, and a good deal of out-of pocket expense, I am slowly regaining more mobility with somewhat less pain.
But some pain, disability and other problems may be permanent and may have already, directly and indirectly, adversely affected my health.
MY BIGGEST MISTAKE: I should never have agreed to Prolia when it had not been on the market for at least five years after FDA approval, and before many problems,
including those resulting from delay (or “stopping” or "discontinuation," to use Amgen's language), had become apparent.
Prolia was marginally helpful, but other approaches might have been safer. Now, despite the problems with this drug, there seems to be no way to stop Proliasafely (without possibly moving to another drug with its own serious problems).
Fractures were the worst but not the only problems associated with Prolia.
Problems involving needed dental care, urinary tract infections, skin problems and other matters are arguably attributable to Prolia as well.
MUCH OF THIS COULD HAVE BEEN AVOIDED. Had Amgen’s patient information specified the hazards of “delay” (as opposed to a direction to “speak to your doctor before stopping Prolia,” especially as “stopping” this drug was not my intention), and had my record been flagged to have me come in for an injection even though a newly assigned doctor could not see me right away, these fractures and the resulting pain and disability might have been avoided.
WHAT CAN YOU DO? With considerable personal effort and expense I am slowly improving, but recovery may never be complete. So to help others avoid what I have suffered, I offer these suggestions to spare your patients this nightmare:
1. Do not prescribe Prolia. If there are safer ways to prevent fractures please consider and recommend them.
2. Report Adverse Drug Reactions arguably associated with Prolia to the FDA.
Report to Amgen as well. (800) 772-6436. You do not need to prove causation to report suspected adverse drug reactions.
3. When patients ask about Prolia (perhaps having seen Amgen’s TV ads), counsel them on the dark side of Prolia, and stress the dangers of delay and other issues with Prolia.
Too busy? Consider the results when patients learn what I have learned so painfully, and prepare someone in your practice to counsel them.
4. For patients now on Prolia, warn about the danger of delay, as they may not understand this from the tiny Amgen tab with their next shot date. To assure this, flag patient records so staff will make sure patients receive Prolia shots on time.
5. Warn patients, as graphically as possible, that what might have been a pleasant and productive part of their lives could be abruptly, painfully, expensively and permanently terminated if they do not get their Prolia shot on time.
Patients may also find resources in this blog, including books and websites with information about osteoporosis and treatments in general.
7. Identify safe protocols to exit Prolia. Research is needed here! I would be grateful to learn whatever you know about this at JoansBackboneDisaster@gmail.com.
8. Identify rehabilitative resources for patients harmed by Prolia. If your institution cannot provide these, identify resources in your community (Medicare reimbursed where applicable) to help patients harmed by Prolia.
IF YOU WORK FORAMGEN, ask yourself: Is Prolia a blockbuster or a bonebuster?
Consider advocating for one or more of the following:
1. Withdrawing Prolia from the market or marketing it only as a last resort for
osteoporosis not treatable by safer means.
2. Withdrawing television and other Direct to Consumer advertising for Prolia.
3. Developing safe exit strategies for those already trapped in a Prolia regimen.
4. Placing Black Box warnings about the danger of delay in all labeling, and highlighting warnings about “delay” (using this word) in patient information.
I regret being unable to meet you and give you this in person. I am still too disabled to travel. But I hope you will consider what I have written here. No one deserves to have an active life destroyed so unnecessarily or so painfully as mine has been You may also reach me via:www.JoansBackboneDisaster.com or at JoansBackboneDisaster@gmail.com
On January 24, 2019 the New York Times published this article on vertebroplasty (surgery involving injection of cement into vertebrae) as treatment for painful vertebral fractures such as I am dealing with now.
I'll add more text about this later but I wanted to get these websites out now.
Once again, anything in these or any other information on these pages you decide to adopt for yourself should be checked out with your own qualified health care provider.
Prolia is an expensive drug. It could cost in the neighborhood of $2000 +/- per year if paid out of pocket. Medicare covered it for me. But the financial fallout from my Prolia disaster promises to exceed this. Neither Amgen nor the University of Chicago are taking any meaningful remedial role, so identifying and implementing care and rehabilitation associated with this debacle mostly comes from my own pocket. http://www.joansbackbonedisaster.com/2018/07/seduced-and-abandoned_5.html)
But without the items below, almost all paid for by me, I don't think I'd have a prayer of recovering my strength or ability to lead even a fairly normal life. (A doctor told me I looked better than most people who had this happen to them. I could only think about how much better those other people would have been if the institutions involved in purveying Prolia had also taken responsibility to clean up the messes associated with this drug.)
My expenses include rehabilitation therapy as well as costs of activities of daily living that I can no longer carry out by myself. Without these, I'd likely have wound up in a nursing home. While cancelling long-anticipated travel plans (because this debacle left me unable to travel) freed some funds, this was definitely not where I planned to spend the money. Here are just a few of the items involved.
1. Physical Therapy. Neither Amgen nor the University of Chicago offered physical therapy so I had to find this on my own. Fortunately my long-time chiropractor helped me identify a skilled physical therapist at a nearby location with whom I work twice a week to correct the spinal curvature that resulted in the course of this debacle and to safely regain some my former strength and mobility. Twenty visits per year are covered by Medicare. I get P.T. twice a week, so add it up! I am fortunate to live in a building with a pool and fitness room to carry out my prescribed exercises. 2. Diet. I'm post menopause but hoped that dietary changes could still be helpful and asked for a referral to a clinical dietician to advise me. The University of Chicago was not able to do this, so I'm researching this my own. I would have appreciated knowledgeable guidance.
3. Activities of Daily Living. Fortunately I live in a well-staffed building for help with things I cannot do now (from changing overhead light bulbs to handling heavy packages of things delivered because shopping is too difficult, etc.) Of course I compensate them for this. I also need a few hours of housekeeping help each week for cleaning and laundry tasks I used to do myself.
4. Help with Food. The first few weeks when I could hardly move I used various meal services. Now I order groceries online that are too heavy to carry, but at least now I can stand upright without pain long enough to do some simple food prep. But this still costs more than when I was doing my own shopping.
5. Transportation to physical therapist, doctor, dentist, means a lot of taxicabs, often to places where I would otherwise have walked or taken the bus. More expense, all uncompensated. I’m just grateful I live in the city and not in the suburbs!
6. Where will I live? Right now, nearly a year after the Prolia disaster I am considering a move to a senior residence with more safety and services, but half the space I now enjoy. I never would have considered this at this age before this disaster! This may be considerably more expensive than my living arrangements now.
Jean Nidetch died a few years ago at age 91. Remember her? Over fifty years ago she created a revolution in the bariatric world when she founded Weight Watchers (r) (hereinafter "WW.") Whatever one may think of WW's diets or other features over the years, the WW model was remarkably successful in helping millions of people lose weight. Its model of regular meetings and other supports is now applied in other chronic disease settings as well, and I submit that this is a model that could be applied to address osteopenia/osteoporosis. I would propose something along similar lines called Bone Builders (BB). (Or a similar name if that is already covered by copyright or trademark). WW meetings, held weekly in convenient locations, were led by trained lay people, and charged a small meeting fee. The meeting model was a lecture by the leader, followed by opportunities for individuals to air their success and problems, and receive applause, ideas and encouragement from others in the group. Group members were asked to maintain individual food intake records in notebooks provided for this purpose. Individual weekly "weigh ins" conducted with privacy at meeting sites allowed members to keep this record of their progress. All of these except the last would be easily replicable in a BB group setting. BB lectures could be by qualified professionals, not only M.D.s, but dietician, exercise professionals and others, followed by opportunities for participants to as questions, and air their successes and problems. BB could offer the many demonstrated advantages of social support in chronic disease settings (and I would submit that osteopenia/osteoporosis is a chronic disease affecting a large population), allowing participants to feel less alone and to get new ideas and constant encouragement in a guided setting about nutrition and exercise. Just a thought from someone who really could have used this years ago when it could have made a world of difference!
These are some articles that have appeared in medical journals in the past few years about the dangers of discontinuing Prolia. You an find most of them on the National Library of Medicine website - https://www.ncbi.nlm.nih.gov . These will be in the databases Pub Med and Pub Med Central (abbreviated as PMC) NCBI stands for National Center for Biological Information run by National Institutes of Health. Some articles are only available as abstracts. Other are available in full text at Pub Med or Pub Med Central. If you go to the publishers you may have to pay. But sometimes if you write to an author they will send you full text (just don't ask authors for medical advice). I've include author information and you can generally Google them to get more info.
Please note that it was never my intention to "discontinue" Prolia. However, nowhere that I can find in Amgen's information about Prolia is the word "delay." As I learned too late, the concept of "delay" appears to be subsumed under the heading of "discontinuing" (or "stopping.") While this might make sense to medical professionals, most lay people would not interpret "delay" as being the same as "stopping" or "discontinuation." Since the topic of this blog is what happened when my Prolia shot was delayed by the prescribing entities, it seems appropriate to include articles about "stopping" or "discontinuing" herein. Again, these are in no way intended as medical advice. Medical advice should come from your qualified medical advisor. Here are just a few citations, followed by abstracts in some instances, and one link to full text.
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Just added in 2020 (published in 2019): Current Osteoporosis Reports
https://doi.org/10.1007/s11914-019-00502-4THERAPEUTICS AND MEDICAL MANAGEMENT (S JAN DE BEUR AND B CLARKE, SECTION
This is one of many related articles by McClung which you may find by clicking on his name.
Please note my own "denosumab holiday" was totally unintentional, as noted elsewhere in this blog, and the result of an entirely avoidable medical clerical error.
But the painful and disabling results were the same!
Author McClung's given address is:
Oregon Osteoporosis Center, 2881 NW Cumberland Road, Portland, OR, 97210, USA. mmcclung@orost.com.
Review Articles:
1. Bone.2017 Dec;105:11-17. doi: 10.1016/j.bone.2017.08.003. Epub 2017 Aug 5.
Discontinuation of Denosumab therapy for osteoporosis: A systematic review and position statement by ECTS.
Department of Medicine III, Technische Universität Dresden, Dresden, Germany; Center for Healthy Aging, Technische Universität Dresden, Dresden, Germany.
2
Medical Department of Endocrinology, Aarhus University Hospital, Aarhus, Denmark.
3
Inserm U1132 and University Paris-Diderot, Department of Rheumatology, Lariboisière Hospital, Paris, France.
4
Centre of bone diseases, Lausanne University Hospital, Lausanne, Switzerland.
5
Department of Clinical Endocrinology, Morbid Obesity and Preventive Medicine, Oslo University Hospital, Institute of Clinical Medicine, Oslo University, Oslo, Norway.
6
Department of Rheumatology, Metabolic Bone Diseases Unit, Hospital Clínic, Barcelona, IDIBAPS, CIBERehd, University of Barcelona, Barcelona, Spain.
7
Department of Internal Medicine, Division of Endocrinology and Diabetology, Medical University Graz, Austria; Center for Biomarker Research in Medicine (CBmed), Graz, Austria.
8
Centre for Genomic and Experimental Medicine, MRC Institute of Genetics and Molecular Medicine, Western General Hospital, University of Edinburgh, Edinburgh, UK.
9
Mellanby Centre for Bone Research, University of Sheffield, UK.
10
Bone Center, Department of Internal Medicine, Erasmus MC, Rotterdam, The Netherlands. Electronic address: m.c.zillikens@erasmusmc.nl.
Abstract
INTRODUCTION:
The optimal duration of osteoporosis treatment is controversial. As opposed to bisphosphonates, denosumab does not incorporate into bone matrix and bone turnover is not suppressed after its cessation. Recent reports imply that denosumab discontinuation may lead to an increased risk of multiple vertebral fractures.
METHODS:
The European Calcified Tissue Society (ECTS) formed a working group to perform a systematic review of existing literature on the effects of stopping denosumab and provide advice on management.
RESULTS:
Data from phase 2 and 3 clinical trials underscore a rapid decrease of bone mineral density (BMD) and a steep increase in bone turnover markers (BTMs) after discontinuation of denosumab. Clinical case series report multiple vertebral fractures after discontinuation of denosumab and a renewed analysis of FREEDOM and FREEDOM Extension Trial suggests, albeit does not prove, that the risk of multiple vertebral fractures may be increased when denosumab is stopped due to a rebound increase in bone resorption.
CONCLUSION:
There appears to be an increased risk of multiple vertebral fractures after discontinuation of denosumab although strong evidence for such an effect and for measures to prevent the occurring bone loss is lacking. Clinicians and patients should be aware of this potential risk. Based on available data, a re-evaluation should be performed after 5years of denosumab treatment. Patients considered at high fracture risk should either continue denosumab therapy for up to 10years or be switched to an alternative treatment. For patients at low risk, a decision to discontinue denosumab could be made after 5years, but bisphosphonate therapy should be considered to reduce or prevent the rebound increase in bone turnover. However, since the optimal bisphosphonate regimen post-denosumab is currently unknown continuation of denosumab can also be considered until results from ongoing trials become available. Based on current data, denosumab should not be stopped without considering alternative treatment in order to prevent rapid BMD loss and a potential rebound in vertebral fracture risk.
Author informationArticle notesCopyright and License informationDisclaimer
Summary
Stopping denosumab after 8 years of continued treatment was associated with bone loss during a 1-year observation study in patients who were not prescribed osteoporosis treatment. Bone loss was attenuated in patients who began another osteoporosis therapy. Treatment to prevent bone loss upon stopping denosumab should be considered.
MRM is a consultant for Amgen Inc., Merck, and Radius Health and receives honoraria from Amgen Inc. and Merck. RBW and AW are employees of and holders of stock and/or stock options in Amgen Inc. PDM receives research grants from Alexion, Eli Lilly, Amgen Inc., Novartis, National Bone Health Alliance, Pfizer, University of Alabama, Boehringer Ingelheim, Merck, Merck Serono, and Radius Health and is a consultant for Grunenthal, Shionogi, Radius Health, Amgen Inc., and Eli Lilly. EML receives research grants from Amgen Inc., Eli Lilly, and Merck and is a consultant for Amgen Inc., Eli Lilly, Merck, and Radius Health.
Go to:
Financial support
This study was sponsored by Amgen Inc., Thousand Oaks, CA, USA.
And here's an article about Prolia issues in the FDA reporting system published in a Legal database, Lawyers and Settlements:
Here is a link to the PRESCRIBING INFORMATION for Prolia published by Amgen and presumably approved by the FDA. But this link will bring you to the current version. https://www.pi.amgen.com/~/media/amgen/repositorysites/pi-amgen-com/prolia/prolia_pi.ahsx This is the "official" document (sometimes called "labeling") from the manufacturer. You may not have been given a copy of this, but now you have it to study and ask questions about! What I learned from Amgen's information: The following is what learned the prescribing information Amgen sent me early in 2018 to tell them about my "backbone disaster:"
5.6 Multiple Vertebral Fractures (MVF) Following Discontinuation of Prolia Treatment
5.6 Multiple Vertebral Fractures (MVF) Following Discontinuation of Prolia Treatment Following discontinuation of Prolia treatment, fracture risk increases, including the risk of multiple vertebral fractures. Cessation of Prolia treatment results in markers of bone resorption increasing above pretreatment values then returning to pretreatment values 24 months after the last dose of Prolia. In addition, bone mineral density returns to pretreatment values within 18 months after the last injection.[see Pharmacodynamics (12.2) and Clinical Studies (14.1)]. New vertebral fractures occurred as early as 7 months (on average 19 months) after the last dose of Prolia. Prior vertebral fracture was a predictor of multiple vertebral fractures after Prolia discontinuation. Evaluate an individual’s benefit-risk before initiating treatment with Prolia. If Prolia treatment is discontinued, consider transitioning to an alternative antiresorptive therapy [see Adverse Reactions (6.1)].
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Patients may not see this. But if they did, and saw the word "discontinuation" they would likely take this to mean stopping a drug with the intent not to return, not a short delay.
And even if they had this document (most patients don't) they might not get to the sentence "New vertebral fractures occurred as early as 7 months... ." Which means that just as my fractures did, they could occur at just one month after the next shot was due.
Also, while I showed evidence of old vertebral fractures, this was never pointed out to me as a risk factor here. And no one at the University of Chicago (U. of C.) took this into account to warn me during the change of doctors that created the delay that resulted in fractures. Nor was this information in the patient information about the drug that I occasionally received with my Prolia shots.
So if you are thinking about Prolia for yourself or a loved one, get an updated version of this document and read it carefully (you should be able to find it online) so you will be able to ask your doctor about anything you don't understand.
