Mr. Robert A. Bradway
Amgen Corporation
One Amgen Center Drive
Thousand Oaks, CA 91320-1799
November 11, 2019
Dear Mr. Bradway:
I am writing to you as CEO of the corporation that manufactures Prolia, a drug intended for osteoporosis, which was marketed to the public not long after it was approved by the FDA in 2010.
I was started on this drug in 2012. With hindsight, I can see that I never should have allowed this so soon after FDA approval. However, once on, I was present for my shot every six months as prescribed until the January of 2018.
At that time there was a DELAY in receiving this drug occasioned by a change in medical personnel at the medical center where I was being treated. I was told not to come in until the new doctor could see me. But within a few weeks after the last shot was due I suffered back pain such as I had never experienced in my life, which turned out to be three vertebral compression fractures.
I reported this to your company and have called them from time to time since to tell them how I am doing during months of physical therapy and pain management assistance.
This has left me partially disabled due to constant pain, and has destroyed much of my active life. From a healthy 81 year old enjoying travel, volunteer work and many activities with friends and family, I have become largely disabled 83 year old, in pain much of the time, making many these activities impossible.
That this short DELAY in receiving Prolia resulted in these fractures was confirmed by the treating physician.
This has been further complicated by the inability of any medical practitioner I have consulted (as well as your own product advisors with whom I have spoken on the phone) in hopes of finding a demonstrably safe way for me to get OFF this drug, and this has created other problems for me, including problems with having needed dental work done.
Over the past year and a half I have met many, many people, mostly older women, on Prolia who have NO IDEA about the danger of delay. In a few instances women have told me that they were going to let their shot go because of a vacation or other reason, and I have been the one to warn them about the possible consequences of this!!!! They hadn’t heard it from their doctors!!!!
This letter comes to you in hopes that you will review what happened to me and consider the remedial actions including the following:
1. Immediately withdraw all Direct to Consumer advertising for Prolia, most particularly your TV advertising.
2. Make it clear in ALL advertising and other publicity, as well as professional and consumer labeling, that:
a. Prolia is a drug with many hazards that should only be prescribed when NO other approaches have worked;
b. Patients must be thoroughly educated that Prolia may create other serious physical and dental treatment problems;
c. Prolia shots cannot be delayed even for a short time (specifically using the word DELAY!), and, most importantly;
d. Once on Prolia, it may be impossible to get off without suffering fractures, no matter what problems it may be creating, and that therefore Prolia should be prescribed ONLY after ALL other options have failed and with FULL DISCLOSURE to patients.
3. Ramp up warnings to specifically warn medical professionals (with BLACK BOX warnings) about the likelihood of fractures after even short DELAY in receiving Prolia, and specifically emphasize the word DELAY.
4. Amplify the labeling on the "tag" given to patients at each Prolia injection to include a warnings similar to those above, and specifically including the word DELAY.
5. Implement research to discover a SAFE way to get OFF Prolia for patients who need to do so for any reason, and make the results of that research available to patients and especially to doctors inquiring about this.
It appears that I am not the only one in this predicament. Even with my limited capacity for research I can see that many others have had experiences similar to mine.
But during the limited time I have left on this Earth, and despite my limited capability because of this Prolia debacle, I'll do my best to warn others so they don't fall into the same Prolia trap that I did!
At a personal level, I urge you to warn your loved ones not to go near this drug that has the capacity to ruin lives as it has mine.
I sincerely hope that you will pledge to use your greater reach to do likewise to save others the suffering I have endured.
Very truly yours,
Joan Levin