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.
https://www.nytimes.com/2019/01/24/health/spinal-fracture-treatment.html
Written by NYT Health Writer Gina Kolata, this article was based on an article published that day in the Journal of Bone and Mineral Research:
https://onlinelibrary.wiley.com/doi/full/10.1002/jbmr.3653
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.
Thursday, January 24, 2019
Thursday, January 3, 2019
THE FINANCIAL FALLOUT
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)
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.
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.
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.
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!
Sunday, December 30, 2018
A MODEL FOR PREVENTION?
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!
.
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!
.
Friday, December 28, 2018
ARTICLES ON DISCONTINUING PROLIA -- INCLUDING "DELAY!"
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.
Just added in 2020 (published in 2019):
Current Osteoporosis Reports
Other Publications:
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.
—————————————————————————
Current Osteoporosis Reports
https://doi.org/10.1007/s11914-019-00502-4THERAPEUTICS AND MEDICAL MANAGEMENT (S JAN DE BEUR AND B CLARKE, SECTION
EDITORS)
Stopping Denosumab
Olivier Lamy1,2 & Delphine Stoll1 & Bérengère Aubry-Rozier1,3 & Elena Gonzalez Rodriguez1,4
# Springer Science+Business Media, LLC, part of Springer Nature 2019
Abstract
Purpose of Review Denosumab discontinuation is associated with a rebound effect manifesting by an increased risk of multiple
spontaneous vertebral fractures. The purpose of this review is to (1) better characterize this risk and (2) find solutions to avoid it.
Recent Findings In the absence of a potent bisphosphonate prescription at denosumab discontinuation, the frequency of multiple
vertebral fractures is common or frequent (≥ 1/100 and < 1/10). In five recent case series, the median number of vertebral
fractures was 5 within 7 to 20 months (median 11) after the last denosumab injection. Prescribing bisphosphonate before starting
denosumab and/or after stopping denosumab may reduce this risk. However, only small case series have evaluated these
strategies.
Summary After the second denosumab dose, there is a rebound effect with an increased risk of multiple vertebral fractures. A
potent bisphosphonate prescribed at denosumab discontinuation could reduce this risk. As denosumab discontinuation is characterized
by many uncertainties, denosumab is a second-line treatment for osteoporosis. Studies are urgently needed to define the
management of denosumab discontinuation.
Keywords Denosumab discontinuation . Osteoporosis . Rebound effect . Spontaneousmultiple vertebral fractures
Other Publications:
Editorial:
This appeared in: Osteoporosis International
, Volume 27, Issue 5, pp 1677–1682| McClung MR
Cancel the denosumab holiday
E-pub 2016 Mar 1
Denosumab is the generic name for Prolia.
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.
Tsourdi E1, Langdahl B2, Cohen-Solal M3, Aubry-Rozier B4, Eriksen EF5, Guañabens N6, Obermayer-Pietsch B7, Ralston SH8, Eastell R9, Zillikens MC10.
(*See abstract of the above article below.)
2. Consult Pharm. 2018 Mar 1;33(3):142-151. doi: 10.4140/TCP.n.2018.142.
Effects of Denosumab After Treatment Discontinuation : A Review of the Literature.
Case Studies:
- J Clin Endocrinol Metab. 2017 Feb 1;102(2):354-358. doi: 10.1210/jc.2016-3170.
Severe Rebound-Associated Vertebral Fractures After Denosumab Discontinuation: 9 Clinical Cases Report.
Lamy O1, Gonzalez-Rodriguez E1, Stoll D1, Hans D1, Aubry-Rozier B1.
Osteoporos Int. 2016 May;27(5):1923-5. doi: 10.1007/s00198-015-3380-y. Epub 2015 Oct 28.
Severe spontaneous vertebral fractures after denosumab discontinuation: three case reports.
Osteoporos Int. 2016 May;27(5):1917-21. doi: 10.1007/s00198-015-3458-6. Epub 2015 Dec 22.
Rebound-associated vertebral fractures after discontinuation of denosumab-from clinic and biomechanics.
Popp AW1, Zysset PK2, Lippuner K3.
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
*Abstract and more of the first review article above:
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.
Tsourdi E1, Langdahl B2, Cohen-Solal M3, Aubry-Rozier B4, Eriksen EF5, Guañabens N6, Obermayer-Pietsch B7, Ralston SH8, Eastell R9, Zillikens MC10.
Author information
- 1
- 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.
Copyright © 2017 Elsevier Inc. All rights reserved.
KEYWORDS:
Denosumab; Discontinuation; Fractures; Osteoporosis treatment; Position paper
PMID: 28789921 DOI: 10.1016/j.bone.2017.08.003
[Indexed for MEDLINE]
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
(Note: The following article received financial support from Amgen.
Osteoporos Int. 2017; 28(5): 1723–1732.
Published online 2017 Jan 31. doi: [10.1007/s00198-017-3919-1]
PMCID: PMC5391373
PMID: 28144701
Observations following discontinuation of long-term denosumab therapy
1,2 R. B. Wagman,3 P. D. Miller,4 A. Wang,3 and E. M. Lewiecki5
Author information Article notes Copyright and License information Disclaimer
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.
Go to:
Contributor Information
M. R. McClung, Phone: 1-503-929-9633, Email: moc.liamg@coo.gnulccmm.
R. B. Wagman, Email: moc.negma@namgawr.
P. D. Miller, Email: moc.loa@RBCCrelliM.
A. Wang, Email: moc.negma@gnawa.
E. M. Lewiecki, Email: moc.liamg@ikceiwelm.
Conflicts of interest
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:
Prolia LInked to Serious Adverse Events in FDA Reporting System
Thursday, December 27, 2018
PROLIA PRESCRIBING INFORMATION FROM AMGEN -- 2018
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:"
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)].
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)].
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
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.
Saturday, December 15, 2018
Stop Prolia at your own Risk!
The 2018 Annual Meeting of the American Society for Bone and Mineral Research ( ASBMR) featured many important reports about osteoporosis drugs.
https://www.medscape.com/viewcollection/34648
An especially important one discussed rebound fractures following discontinuation of Denosumab - which is Prolia.
https://www.medscape.com/viewcollection/34648
An especially important one discussed rebound fractures following discontinuation of Denosumab - which is Prolia.
###
Wednesday, December 12, 2018
CHECKING IN WITH AMGEN -- AGAIN!
Every few weeks I check in with Amgen -- the manufacturer of Prolia -- to tell them how I'm doing.
I'm sure they are concerned so I want to let them know!
I use the number they give for this purpose: 800-772-6436 which is staffed by nurses and pharmacists.
They record calls (which is what I want them to do) and they often say they will report this to their "safety" division, but they don't give advice. They just tell you to "ask your doctor" and in my case that's turned out to be something of a blind alley in terms of getting the information I most need!
However I continue to call Amgen on a fairly regular schedule, especially since their lawyer called me (as noted elsewhere on these pages) and told me not to do so. Recently my goal was to let them know that while I can now actually stand or sit for an hour now without too much pain, much more than that is still painful. In the interest of keeping what happened to me from happening to others I want to make it very clear that I think the word "delay" belongs on their warnings about Prolia.
They do mention in their professional labeling that "stopping" Prolia can result in vertebral fractures, but nowhere could I find the word "delay."
They warn not to stop (or discontinue) Prolia without informing their health care advisor. But in my case, this drug was delayed BECAUSE of my health care provider!
And never once in the time before that had I considered "stopping" the drug.
When I have shared this with the Amgen phone personnel I have never gotten a good answer.
I have tried to explain that for most speakers of the English language the words "stopping" or "discontinuing" connote both intentionality and permanency. ("Have you stopped smoking?" Most people who say they have stopped smoking do not INTEND to start again. True, they might smoke in the future, but this was generally NOT their intent when they STOPPED.)
I would say that whatever special connotation the words "stop" or "discontinue" might have for doctors, for most patients these words used in connection with a regular activity imply termination, not delay, of an action.
I never intended to STOP Prolia. Although I had some problems with it (the back pain, the itching skin, the issues getting needed dental work done) it appeared to be of some value in slowing bone loss, at least as reflected in DEXA scores (although this may not be such a great indicator as I'm coming to learn).
My Prolia injection scheduled for late January 2018, was delayed as noted before because of a change in medical personnel at the U. of C. and no one there seemed to have the time or inclination to take a minute to give me a call and say "Hey, Joan, even though you don't have a doctor here right now, come on in at the scheduled time for your Prolia shot, because even a short delay could leave you with broken bones and lengthy or even permanent pain and disability!"
Instead I was simply informed at that my doctor had left, that my late January appointment was cancelled and the new doctor would not be able to see me until late in May. And sometime in early March my bones broke in a painful collapse!
So you can imagine the urgency when, after asking several times earlier and getting no definitive answer, I finally asked the people at the Amgen phone number (800-772-6436) several times until I got a YES for this specific request: "Will you tell your "safety team" that you received a specific request that the word 'delay' be included in labeling." I had to ask this representative three times before she finally said that she would do this.
I asked her who was on their "safety team" and she said she was not authorized to give that information. I'd like to reach them and if anyone has ideas about this let me know! I'd like to know what they are doing about this important safety matter!
I'm sure they are concerned so I want to let them know!
I use the number they give for this purpose: 800-772-6436 which is staffed by nurses and pharmacists.
They record calls (which is what I want them to do) and they often say they will report this to their "safety" division, but they don't give advice. They just tell you to "ask your doctor" and in my case that's turned out to be something of a blind alley in terms of getting the information I most need!
However I continue to call Amgen on a fairly regular schedule, especially since their lawyer called me (as noted elsewhere on these pages) and told me not to do so. Recently my goal was to let them know that while I can now actually stand or sit for an hour now without too much pain, much more than that is still painful. In the interest of keeping what happened to me from happening to others I want to make it very clear that I think the word "delay" belongs on their warnings about Prolia.
They do mention in their professional labeling that "stopping" Prolia can result in vertebral fractures, but nowhere could I find the word "delay."
They warn not to stop (or discontinue) Prolia without informing their health care advisor. But in my case, this drug was delayed BECAUSE of my health care provider!
And never once in the time before that had I considered "stopping" the drug.
When I have shared this with the Amgen phone personnel I have never gotten a good answer.
I have tried to explain that for most speakers of the English language the words "stopping" or "discontinuing" connote both intentionality and permanency. ("Have you stopped smoking?" Most people who say they have stopped smoking do not INTEND to start again. True, they might smoke in the future, but this was generally NOT their intent when they STOPPED.)
I would say that whatever special connotation the words "stop" or "discontinue" might have for doctors, for most patients these words used in connection with a regular activity imply termination, not delay, of an action.
I never intended to STOP Prolia. Although I had some problems with it (the back pain, the itching skin, the issues getting needed dental work done) it appeared to be of some value in slowing bone loss, at least as reflected in DEXA scores (although this may not be such a great indicator as I'm coming to learn).
My Prolia injection scheduled for late January 2018, was delayed as noted before because of a change in medical personnel at the U. of C. and no one there seemed to have the time or inclination to take a minute to give me a call and say "Hey, Joan, even though you don't have a doctor here right now, come on in at the scheduled time for your Prolia shot, because even a short delay could leave you with broken bones and lengthy or even permanent pain and disability!"
Instead I was simply informed at that my doctor had left, that my late January appointment was cancelled and the new doctor would not be able to see me until late in May. And sometime in early March my bones broke in a painful collapse!
So you can imagine the urgency when, after asking several times earlier and getting no definitive answer, I finally asked the people at the Amgen phone number (800-772-6436) several times until I got a YES for this specific request: "Will you tell your "safety team" that you received a specific request that the word 'delay' be included in labeling." I had to ask this representative three times before she finally said that she would do this.
I asked her who was on their "safety team" and she said she was not authorized to give that information. I'd like to reach them and if anyone has ideas about this let me know! I'd like to know what they are doing about this important safety matter!
Sunday, December 2, 2018
I HAVE QUESTIONS; HOW ARE THEY ANSWERED?
I've always asked questions. In the end, I'm the one who lives or dies, or, in my current state, is rendered a semi-invalid, by the information I am receiving. So yes, I ask questions. I only wish I had asked more questions about Prolia before agreeing to it.
Sometimes doctors tell me to "trust" them. I remind them as politely as I can that trust is earned, not given. (That usually is not received well. One doctor "fired" me for saying words to that effect. So I try my best to tread more carefully.)
I realize that doctors do not have the time to answer a lot of questions, so I'm often left pretty much in the dark, especially when different doctors suggest different approaches.
I recently asked a doctor questions about a drug and was asked, in reply, if I was "getting information from the internet." This was said in way that made me think that this doctor did not think much of the internet as a source of information.
But what am I to do, given the following?
1. Doctors' time is generally limited, so often the only information about a drug is from the manufacturer via their labeling. My experience has been that a search for information should not stop with the manufacturer's information. While this may be "approved" by the Food and Drug Administration (FDA), it may not tell the full story. (For instance, I never knew beforehand that starting Prolia, as a practical matter, amounted to a "life sentence.") So to fill in these gaps I must rely on other resources. Today, these resources are mostly on the internet.
2. Most local medical libraries are not open to the public, and in any event, traveling to them and using Index Medicus and taking notes and xeroxing pages in a library is time consuming and expensive. Plus I'm not in great shape (as noted elsewhere on these pages) so I appreciate the internet based systems now available that I can access from my home.
Here, in no particular order of importance are some of the places I've found information:
1. First and foremost of these internet resources is NCBI (the National Center for Biological Information) run by the Federal government as part of the system that includes the databases of the National Library of Medicine, carrying thousands of medical journals and other resources.
https://www.ncbi.nlm.nih.gov
When I find applicable articles here I read their abstracts (and the entire article if it is online) and, if possible, ask the doctor about about things I don't understand. Some journals are more useful and reliable than others, and here too a doctor can be helpful.
(Note: In the '80's and '90's I used NCBI's predecessor called "MEDLARS" (Medical Literature Analysis and Retrieval System) also operated by the Federal government. It had its own direct computer-based access via modem to National Library of Medicine. But this system has long since been replaced by the internet-based NCBI system above.)
2. Medical social media websites where people post their own experiences with various kinds of treatments offer information mostly from lay people. Without knowing more about those posting, it may be hard to evaluate this information, but, especially when you see enough posts about the same kinds of issues, this information could be valuable. I have listed some of these in this blog at: http://www.joansbackbonedisaster.com/2018/09/health-unlocked.html
3. Popular media. Many national newspapers and magazines that publish on the internet have excellent health and medical reporters on staff so that when stories appear about specific matters it can justify asking more questions. This is why I posted some articles from the New York Times about some surgical approaches to vertebral fractures like the ones I suffered following the Prolia delay. https://www.blogger.com/blogger.g?blogID=5152345338722870195#editor/target=post;postID=7271280824993248116;onPublishedMenu=allposts;onClosedMenu=allposts;postNum=8;src=postname.
4. Websites of public interest organizations often have useful information. You have to know your organization, but many have knowledgeable experts who are careful about what they write. Public Citizen is one example. See posts about them elsewhere in this blog. I wish I'd paid more attention to them earlier.
5. Websites devoted to specific medical topics. Again, you need to evaluate them carefully, but I've featured a few I've found helpful ones on osteoporosis in this blog.
http://www.joansbackbonedisaster.com/2018/10/some-helpful-websites_14.html
6. Books, both popular and technical can offer some information. Popular books depend on the ability of the author to accurately interpret and convey scientific information. I've mentioned some that I've found helpful, but once again, I am not endorsing any of them or recommending following them to anyone. Here are a few I've been reading: http://www.joansbackbonedisaster.com/2018/11/some-books-im-reading.html
7. Miscellaneous sources that might not be as well vetted. These are still worth looking at because they can offer clues leading to finding information from more reliable sources.
So yes, Dear Doctor, I get some of my information from the internet. As noted, I've listed some resources for this elsewhere.
Please note that nothing here is an endorsement. I am not qualified to recommend any of these sources to anyone. Those with questions may just have to puzzle it out for themselves, or, if they are very lucky, find qualified experts to help them in this regard.
Sometimes doctors tell me to "trust" them. I remind them as politely as I can that trust is earned, not given. (That usually is not received well. One doctor "fired" me for saying words to that effect. So I try my best to tread more carefully.)
I realize that doctors do not have the time to answer a lot of questions, so I'm often left pretty much in the dark, especially when different doctors suggest different approaches.
I recently asked a doctor questions about a drug and was asked, in reply, if I was "getting information from the internet." This was said in way that made me think that this doctor did not think much of the internet as a source of information.
But what am I to do, given the following?
1. Doctors' time is generally limited, so often the only information about a drug is from the manufacturer via their labeling. My experience has been that a search for information should not stop with the manufacturer's information. While this may be "approved" by the Food and Drug Administration (FDA), it may not tell the full story. (For instance, I never knew beforehand that starting Prolia, as a practical matter, amounted to a "life sentence.") So to fill in these gaps I must rely on other resources. Today, these resources are mostly on the internet.
2. Most local medical libraries are not open to the public, and in any event, traveling to them and using Index Medicus and taking notes and xeroxing pages in a library is time consuming and expensive. Plus I'm not in great shape (as noted elsewhere on these pages) so I appreciate the internet based systems now available that I can access from my home.
Here, in no particular order of importance are some of the places I've found information:
1. First and foremost of these internet resources is NCBI (the National Center for Biological Information) run by the Federal government as part of the system that includes the databases of the National Library of Medicine, carrying thousands of medical journals and other resources.
https://www.ncbi.nlm.nih.gov
When I find applicable articles here I read their abstracts (and the entire article if it is online) and, if possible, ask the doctor about about things I don't understand. Some journals are more useful and reliable than others, and here too a doctor can be helpful.
(Note: In the '80's and '90's I used NCBI's predecessor called "MEDLARS" (Medical Literature Analysis and Retrieval System) also operated by the Federal government. It had its own direct computer-based access via modem to National Library of Medicine. But this system has long since been replaced by the internet-based NCBI system above.)
2. Medical social media websites where people post their own experiences with various kinds of treatments offer information mostly from lay people. Without knowing more about those posting, it may be hard to evaluate this information, but, especially when you see enough posts about the same kinds of issues, this information could be valuable. I have listed some of these in this blog at: http://www.joansbackbonedisaster.com/2018/09/health-unlocked.html
3. Popular media. Many national newspapers and magazines that publish on the internet have excellent health and medical reporters on staff so that when stories appear about specific matters it can justify asking more questions. This is why I posted some articles from the New York Times about some surgical approaches to vertebral fractures like the ones I suffered following the Prolia delay. https://www.blogger.com/blogger.g?blogID=5152345338722870195#editor/target=post;postID=7271280824993248116;onPublishedMenu=allposts;onClosedMenu=allposts;postNum=8;src=postname.
4. Websites of public interest organizations often have useful information. You have to know your organization, but many have knowledgeable experts who are careful about what they write. Public Citizen is one example. See posts about them elsewhere in this blog. I wish I'd paid more attention to them earlier.
5. Websites devoted to specific medical topics. Again, you need to evaluate them carefully, but I've featured a few I've found helpful ones on osteoporosis in this blog.
http://www.joansbackbonedisaster.com/2018/10/some-helpful-websites_14.html
6. Books, both popular and technical can offer some information. Popular books depend on the ability of the author to accurately interpret and convey scientific information. I've mentioned some that I've found helpful, but once again, I am not endorsing any of them or recommending following them to anyone. Here are a few I've been reading: http://www.joansbackbonedisaster.com/2018/11/some-books-im-reading.html
7. Miscellaneous sources that might not be as well vetted. These are still worth looking at because they can offer clues leading to finding information from more reliable sources.
So yes, Dear Doctor, I get some of my information from the internet. As noted, I've listed some resources for this elsewhere.
Please note that nothing here is an endorsement. I am not qualified to recommend any of these sources to anyone. Those with questions may just have to puzzle it out for themselves, or, if they are very lucky, find qualified experts to help them in this regard.