PUBLIC CITIZEN HEALTH RESEARCH GROUP PETITIONS THE FDA FOR BETTER WARNINGS ABOUT PROLIA

Public Citizen Health Research Group recently petitioned the Food and Drug Administration (FDA) for better warnings about the osteoporosis drug Prolia.

While most of the suggestions in that Petition were ignored, the FDA agreed to some modest changes.  

You can read the entire petition and the FDA response here:

https://www.citizen.org/article/petition-to-the-fda-to-require-a-black-box-warning-for-the-osteoporosis-drug-prolia/

Readers in a hurry can get the gist of the Petition from the press release: 

https://www.citizen.org/news/patients-doctors-must-be-warned-about-risk-of-spinal-fractures-soon-after-stopping-osteoporosis-medication/

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CAN AMGEN EVEN KEEP ITS OWN STORY STRAIGHT?

I keep in touch with Amgen, manufacturer of Prolia in a few different ways.  

Sometimes I call them at their phone number for this purpose: 1.800.772.6436.  There I generally speak with either a nurse or some other medical professional.  There is nothing they can do for me but listen, and that they do very kindly.  They never offer any useful information.  (That, they tell me, is only for my doctor to do!)

Sometimes I write to the President of Amgen, Mr. Robert Bradway.  I'm sure he never reads these letters, but I generally get an answer signed by someone named Gunjan Thiagarajah, who appears -- as far as I can figure out from www.Amgen.com to serve in some sort of marketing function. 

The following is not really about my Prolia-related broken back, but a incident that really leaves me wondering more than ever about Amgen!

On March 25, 2020 I telephoned called Amgen however, to express concern that supplies for patients on Prolia might be interrupted during the current COVID-19 situation.   I spoke with a very nice nurse who identified herself as "Lucy."  

I explained to Lucy that since (as described elsewhere in this blog) a brief delay in my Prolia shot left me with fractures that had pretty much ended my active life, I did not want to risk still more damage if Prolia were not available for my next shot which was to be on April 14. 

 On Sunday April 5 I received a UPS Express envelope containing a letter from Amgen: a single sheet dated April 3, 2020 addressing this issue. It cited Amgen's information source for COVID-19 issues: www.amgen.com/covid-19 and also offered a resource for doctors to find alternative sites of care for Prolia injections www.proliafinder.com. It was signed by the above Gunjan Thiagarajah.  Not the most reassuring letter about my specific concerns but at least it was something.   

But on Monday April 6, 2020, around 5:30 p.m. I actually received a telephone call from a woman who said she was from Amgen.  And it also seemed to come in response to the telephone call I made on March 25th (in which I spoke to Lucy).       

I had a hard time understanding this caller but she spelled out her name and I think it was Sama Hassan.    I could not find this name anywhere on the Amgen.com website.

I may have gotten a return call before in response to a phone call I'd made, but generally I get no response to these calls that I make about once a month.  And certainly not TWO responses! 

As noted, she said she was responding to my call of March 25, 2020, in which I brought Amgen up-to-date on how I was getting along since my Prolia disaster.  

She said she had "material for my doctor" if I would give her my doctor's name.  I said there had been three doctors in two different institutions  involved with my care -- the one who put me on Prolia in 2012, then, after he retired in 2016, the one who came in after my bones had broken because I had been unable to get my regular Prolia shot on time during this change, and finally the doctor I am seeing now.  

But I continued, saying that while I would be glad to give her these names, I first wanted a copy of whatever she was going to send them.    

She said she could not authorize that and would have to check with the the proper people to see if she could do that!  So watch this space!  We might learn what exciting information Amgen imparts to doctors but not to patients!   

I did get my Prolia shot at Northwestern on time on Tuesday, April 14, 2020, but I have yet to figure out what all these calls were about.  And I have yet to get the "doctors only" material from Amgen. Are Amgen's internal processes just as screwed up as they were at the University of Chicago?    I'll never know!

MEDICAL AND DENTAL CARE IN THE TIME OF CORONA VIRUS

(Note, this is also printed at my blog https://joanscovid19blog.blogspot.com/2020/04/medical-and-dental-care-in-time-of.html )

(With apologies to Colombian Nobelist Gabriel Garcia Márquez, author of Love in the time of Cholera.)

As readers of these pages know, I have been dealing with the fallout from painful multiple vertebral fractures occurring following the medical mismanagement of the osteoporosis drug, Prolia. Now, two years and a lot of physical therapy later, I can now walk a little and remain upright (standing or sitting) without too much pain for an hour or two.    I've given up my car; driving was just too distractingly painful, and I avoid theatre or concerts or anything requiring me to remain quietly seated for an hour or more with no opportunity to depart quietly and gracefully when the pain becomes too intense.

But now comes another issue which is causing me great consternation and one more example of the negotiations I must carry out when various health professionals present me with conflicting sets of requirements, and where the consequences to me of a slip-up could be more painful, debilitating, independence-threatening fractures!

Early in 2020 I had a toothache.  A bad one!  Dental x-rays revealed a broken root, but I had to wait almost six months until the tooth could be extracted because I was on Prolia.  This is because apparently Prolia leaves your jaw vulnerable to fracture.   At first I was told I had to be OFF Prolia completely before this tooth could be extracted -- which could have left me quite vulnerable to more fractures!    I discuss this on these pages at:
http://www.joansbackbonedisaster.com/2019/12/a-cruel-prolia-related-choice-must-i.html

So in view of the dire consequences of even a short delay in getting a Prolia shot (caused by medical mismanagement of this drug as discussed elsewhere in this blog) I wanted to make sure there would be no delay here in getting my Prolia shot April 14 (the mandated six months and 5 days for spacing Prolia injections.)

I knew this would take a lot of juggling because despite the fact that the two doctors involved are across the street from each other in Northwestern Medical Center buildings, and both have telephones,  they do not  communicate with each other, leaving me to fly back and forth like a Carrier Pigeon with messages.   But I finally was able to establish two dates:
April 8 for Oral Surgeon follow-ip exam.
April 14 for Prolia shot.

I had already cancelled many other medical checkups with other doctors who agreed that I did not need to come to their offices as scheduled given the Corona Virus danger.   (In fact some of them were no longer even coming to their offices!)

So inasmuch as the Oral Surgeon did not seem to think I needed to come in for  a "follow up" I cancelled that.  We agreed that additional exposure to COVID-19 was unnecessary.


Corona Virus - COVID-19 -- Complicates Matters!   To recap, the broken tooth having been extracted as scheduled on March 10, in the normal course of events, the Oral Surgeon would examine me ten days later and then I would get the Prolia shot as scheduled on April 14.

But by early March, the "normal course of events" was history.  Corona Virus -- COVID-19 -- was on a rampage around the world, with no effective prevention methods in sight.  Our political leaders and medical experts were adamant in the importance of personal protection by quarantine and self-isolation, and knowing that at age 83 I was in an especially vulnerable age cohort, I was carefully observing that, staying in my home, having no visitors, and sending out for my groceries.

But as the time for my Prolia shot came due, I knew I would have to leave my carefully maintained  COVID-19 free quarters and venture to Northwestern University medical buildings two more times: First, to have my "follow up" appointment with the Oral Surgeon, and then several days later for the Prolia shot.

So to minimize this exposure, I called the Oral Surgeon's office and reported that the extraction site felt fine; no pain, no swelling, and it was agreed that I could defer the follow-up visit to minimize COVID-19 exposure risk.

But this did not work for the Prolia doc's office where I was told that following the March 10 extraction, I MUST see the Oral Surgeon to be "cleared" for the Prolia shot.   So I dutifully called back and reestablished the Oral Surgeon follow-up exam for April 8 and then the Prolia shot on April 14.

It appeared then that I would have to go out out TWICE, with TWO exposures to COVID-19 in order to get the Prolia shot on time so that I wouldn't have MORE fractures!   Talk about a rock and a hard place!

So I was really delighted when the Oral Surgeon said that since I reported (honestly) to him that following the extraction I had no pain or swelling and that the site was well healed,  that I could cancel the "post extraction" exam and get the Prolia shot at the scheduled time. 

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