I'm a non-smoker, an almost totally abstemious drinker, a huge consumer of fresh fruits and vegetables including those high in calcium and other bone-building nutrients, and a moderate consumer of fish (especially salmon with bones) and occasional eggs. I'm a big city walker and for years have worked regularly with a trainer with heavy weights, which I don't particularly enjoy but which I have done primarily to maintain bone density. Because of allergies I'm gluten- and casein-free.
Around 2012 I consulted a bone endocrinologist, Dr. A* at the medical center of the University of Chicago (U. of C.). The U. of C. prides itself on being on the front line of medicine.
Dr. A.*, suggested trying Prolia. This drug had not been on the market long. In fact it had only been approved by the FDA about two years earlier, and that should have been a red flag right away.
You can read about this history in this blog at: http://www.joansbackbonedisaster.com/2020/07/prolias-approval-timeline.html
I do not think it is a good idea to take a new drug until at least five years following FDA approval. This is because the number of people tested in pre-marketing clinical trials is much lower than the number who may be taking it when it is on the market, especially when it is heavily promoted, so larger numbers of adverse effects may not show up than in the earlier testing phases.
But I was frightened, and at that point I even trusted the doctor, so despite my general aversion to pharmaceuticals -- especially newer ones -- and mostly out of desperation as I watched my DEXA scores tumble, and with growing fears of disabling fractures and no other solution in sight, I decided to try it.
Prolia is administered by injection very six months. So every six months like clockwork I went to the University of Chicago Hyde Park campus for an injection. Once a year, on that same day I would also see Dr. A.* And every two years, also on the same day, I would have a DEXA scan.
I kept these appointments faithfully. While technically the doctor visit, the Prolia shot and the DEXA scan were three separate appointments, I always saw them as one appointment when I went to the U of C., and they were treated as such by the reminder calls I received. On my day to go there for one, two or all three of these things, I just went for whatever was on the menu for that day, and was always present on time for these appointments.
A Delay
Shortly before my appointment was scheduled for January 22, 2018, the U. of C. called to say that Dr. A. could not be there and I should come back two weeks later. So I wrote the new date on my calendar.
But just before that new date, the U of C called to say that Dr. A. would not be returning, and I would see another doctor, Dr. B.* Dr. B. did not have an open appointment until the end of May so I put that new date on my calendar.
I SPECIFICALLY ASKED ABOUT THE PROLIA SHOT THAT WOULD HAVE BEEN DUE ON JANUARY 22 ALONG WITH THE DEXA SCAN.
THAT I HAD NEVER MISSED (OR BEEN LATE) FOR AN APPOINTMENT FOR THIS SHOT SUGGESTS THAT I TOOK THIS SERIOUSLY.
I WAS TOLD THAT THIS TOO WOULD HAVE TO WAIT UNTIL I SAW THE NEW DOCTOR FOUR MONTHS LATER.
HERE IS WHERE I MADE THE BIGGEST MISTAKE OF MY LIFE! I ACTUALLY BELIEVED WHAT THEY TOLD ME! I ACTUALLY THOUGHT THEY KNEW WHAT THEY WERE DOING!
HOW WRONG I WAS!
IT IS STAGGERING TO THINK THAT A WORLD FAMOUS MEDICAL INSTITUTION OF THE STATURE OF THE UNIVERSITY OF CHICAGO COULD NOT MANAGE A SIMPLE SCHEDULING TASK LIKE THIS!
-- THIS WAS AN INJECTION ADMINISTERED BY A NURSE! -- NO DOCTOR WAS NEEDED!
--- I HAD BEEN ON THIS DRUG FOR SIX YEARS!
--- A PHONE CALL, A LETTER OR EVEN A POSTCARD SIMPLY SAYING: THE NEW DOCTOR CANNOT SEE YOU BUT YOU CAN COME IN FOR YOUR PROLIA SHOT WOULD HAVE SUFFICED.
I HAD DONE MY PART AND NOT MISSED A DATE FOR THIS IN SIX YEARS. COULD IT BE THAT THE SAME UNIVERSITY OF CHICAGO THAT GAVE US THE ATOM BOMB COULD NOT EVEN MANAGE THIS?
DISASTER!
During a vacation in late February 2018, I began to experience severe back pain which I ascribed to handling heavy luggage and terrible plane seats. Once home, it became a lot worse and, not thinking this was related to Prolia, I went to see my regular internist on March 14, 2018.
By this time the pain was excruciating and even the short trip downtown to see the doctor was unbelievably painful. He sent me for an MRI which was also unbelievably painful. It turned out I had new compression fractures in three vertebrae: T11, T12 and L3. (Also, the MRI showed some some old compression fractures in L2, and L3 and endplate compression at T9 of which I had not been aware).
The whole report said:
"VFA was visualized from T3 to L4 and showed fractures L4, L3, L2, T12, T11 and end plate compression at T9."
I immediately e-mailed the new bone endocrinologist at the University of Chicago, Dr. B. (whom I had not yet seen) about this, who indicated that this was because I'd "stopped Prolia." I replied that it had never been my intent to "stop Prolia" and Dr. B. said that recent literature showed even short delays in receiving these injections could entail fractures.**
This had never been explained to me, and we had some discussion about this. The U. of C. already had my record flagged that I'm on Medicare so that their schedulers would have known that my expensive Prolia shots needed to be not just six months apart, but AT LEAST six months and five days apart to qualify for Medicare coverage. So there seemed to me to be no reason why my record couldn't have also been flagged to make schedulers aware of the danger of delay.
So I finally received the Prolia shot that I should have been given on January 23, 2018 on March 16, 2018, by which time my back had broken in three places!
These fractures almost certainly occurred at some point during a trip I took in late February, shortly after University of Chicago had cancelled my scheduled Prolia shot because of the retirement of my doctor and before the new University of Chicago could see me.
How easy it would have been for the University of Chicago to have said something to this effect: "Dr. A. has retired and cannot see you, but you are regularly on this drug and a delay could mean fractures. Please come in and a nurse will give you your Prolia shot and you can see the new doctor, Dr. B., as soon as she has a free hour for an appointment."
Had this been done, had someone reached out to tell me that even though my former doctor was gone and the new doctor couldn't see me until months later in late May, and that I should still come in for that Prolia injection even though I hadn't seen the new doctor yet, all of this pain and disability would likely have been avoided.
Similarly, an adequate warning by Amgen, Prolia's manufacturer, about the danger of "delay" could have averted this disaster. Amgen cautions patients: "speak to your doctor before stopping Prolia." But I'd never considered "stopping" Prolia. And, as noted above, it was "my doctors" who delayed my appointments.
In fact, at that time I could not find the word "delay" anywhere in Prolia's labeling for doctors or patient information. While as noted elsewhere there are warnings against "discontinuation" I had no intention of stopping Prolia.
While doctors might understand "discontinuation" to subsume "delay" I believe there is no excuse for failing to include the word "delay" in patient information intended for lay people.
NOTE ADDED January, 2020: It pains and angers me to think that these past four years of pain, disability and expense, with no end in sight, could have been averted with just one word from a properly trained scheduling clerk when they informed me of the change in doctors.
I could easily have come in for that January 2018 appointment and a nurse could have given me the shot. I wouldn't even had to have seen a doctor! Had there been a warning about DELAY in Amgen's literature at the time it also would have helped me make a stronger argument for this.
What a shameful, dreadful, inexcusable waste of a reasonably healthy (albeit aging) body! What a waste of a still productive life!
I see that Amgen has now added the word "DELAY" in at least one of its patient advisories -- although not in a way most people would be likely to notice. I'm glad they are at least doing this now.
As you will see in these pages one of the doctors now hands out a warning about getting Prolia shots on time, but in my view this warning is totally inadequate.
I am not aware of any changes made in record flagging or support staff training in this regard but I surely hope that this has been done. One totally avoidable "accident" like mine is one too many!
As this blog proceeds I'll update some of the things that I have dealt with over the following months of pain, disability and expensive rehabilitation.
What a shameful, dreadful, inexcusable waste of a reasonably healthy (albeit aging) body! What a waste of a still productive life!
I see that Amgen has now added the word "DELAY" in at least one of its patient advisories -- although not in a way most people would be likely to notice. I'm glad they are at least doing this now.
As you will see in these pages one of the doctors now hands out a warning about getting Prolia shots on time, but in my view this warning is totally inadequate.
I am not aware of any changes made in record flagging or support staff training in this regard but I surely hope that this has been done. One totally avoidable "accident" like mine is one too many!
As this blog proceeds I'll update some of the things that I have dealt with over the following months of pain, disability and expensive rehabilitation.
Update: I am writing this paragraph on April 2, 2021. I continue in pain. Normal life is impossible. It has been four years now and I cannot even remember what it is like to have a day without pain, let alone the pleasure of a mid-winter sunshine getaway!
I still see Direct-to-Consumer advertising about Prolia on TV, and I watch these ads with horror, hoping that by now more people (and their doctors!) are aware of this drug's dirty little secret as I continue to deal with daily pain and disability because of a simple failure to give adequate warning about the hugely destructive potential of this drug!
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*Note that while I am not naming the U. of C. physicians involved in this debacle, and while I believe that much of the harm I incurred was because of Amgen's failure to include specific warnings about the danger of delay, especially in its literature for patients, as well as the University of Chicago's failure to have a system in place to warn patients about this as well, I wish Dr. A and Dr. B had each played a more proactive role in preventing this painful fall through the cracks resulting from the U. of C.'s internal personnel changes.
** In future posts I hope to offer more information about fractures occurring after such delays, including information published in the medical literature before my fractures occurred, but for now suffice it to say that they DID occur and were almost certainly related to this short delay, occasioned by what I would call a manufacturer's failure to warn coupled with a totally avoidable medical clerical error by the U. of C.
** In future posts I hope to offer more information about fractures occurring after such delays, including information published in the medical literature before my fractures occurred, but for now suffice it to say that they DID occur and were almost certainly related to this short delay, occasioned by what I would call a manufacturer's failure to warn coupled with a totally avoidable medical clerical error by the U. of C.
