When “No” Isn’t Good Enough: Advocating for Ourselves in the COVID-19 Environment
About a month ago, it was becoming evident that Piqray was failing me and that it was time to change to a new drug. I have metastatic Triple-Negative Breast Cancer (mTNBC) and have the PIK3CA mutation, so we were happy that it worked as long as it did. We always knew that my next drug would be IMMU 132, Immunomedic’s antibody-drug conjugate. When first had discussed IMMU 132, my oncologist had assured me that I could access it through a clinical trial...
But then came COVID-19. It was time for me to start IMMU 132 and the company had suspended all new enrollment to clinical trials. I’m sharing with you my story about how I was able to get this drug, in spite of many challenges.
New treatment for metastatic triple-negative breast cancer
1. First, I contacted the drug company to find out if there is any way to access the drug outside of the clinical trial setting
I learned that there is an expanded access program, which means under special circumstances your doctor can request the drug for you. My medical team was not aware of this particular expanded access program and it was frankly because of my experience and contacts in the pharma industry that I knew about it. My doctor applied for me to participate in the expanded access program. Two Medical Directors at the drug company reviewed and approved my request. Then the FDA approved it. No small thing, right, especially to get FDA approval during this chaotic time!
2. Until I received the surprising news that my hospital was now saying no!
The hospital had just decided that no new patients can enroll in any trials due to COVID-19. My doctor and I agreed that expanded access is not the same thing as a trial. But that was the way the hospital-powers-that be were classifying things, even if this made little sense to us.
3. I decided not to take No for an answer
This drug could save my life. COVID-19 hospital protocols were no excuse. So my doctor gave me the name of the hospital administrator who had said no. I called his office and left an urgent message with his secretary and sent him an email as a follow-up. I think my communication strategy was effective for a few reasons:
- Nowadays, many people rely solely on email and do not call. The fact that I called showed that I was serious and was not going to go away easily. Be heard and don’t rely solely on email!
- I educated the decision-maker on the importance of this drug. I looked up this doctor and determined he was pretty outside the field of breast oncology, and probably didn’t realize the clinical significance of this drug. I showed him that I had done my research and I knew why this was the right decision.
- I tried to humanize myself, to make me more than just a number
- I expressed urgency about my cancer progressing
I am sharing this email with you as it could be a helpful template for you if you are in a similar situation.
I am writing to you to appeal this decision. I am 46 years old and have metastatic, triple-negative breast cancer. This is the most deadly form of breast cancer and other than PD-L1 targeting agents, until now, there have been no specific therapies for mTNBC.
IMMU 132 offers me the best chance to prolong my life. In just a year and a half, I have already had 3 therapies fail me. IMMU 132 has the best track record and a novel mechanism of action. The earlier on we can introduce novel agents into my treatment, the more I will be able to benefit from them.
Dr. Y has recommended IMMU 132 through the company’s expanded access program. As Dr. Y noted in his email to you below, “This does not involve any personal interaction with the research staff and not a study. It is a form of regular care that any doctor can provide and not research.” This is not a clinical trial.
Other than mTNBC I am healthy. This drug will have FDA approval soon, but not soon enough for me. It is not an unknown entity. TNBC specialists like Dr. Y know this drug well.
I am begging you to reconsider your decision. I have a husband and a young son. In the past week, I have had 2 friends in their early 40’s die from mTNBC. They didn’t have access to IMMU 132. I have suffered a lot and I have much living I want to do still. I am a mother. I have a Ph.D. in literature. I am a patient advocate. I volunteer my time for the cancer community. I have a lot I want to do. My family needs me. Please. I have reviewed the clinical data carefully. IMMU 132 will give me the best chance. Dr. Y agrees.
My cancer is progressing so I need your approval on this immediately so I can start this drug.
4.The Upshot: I got the drug!
Dr. X sent me a very nice note right away, explaining that they actually had not said “No,” but there were more issues to address, such as identifying where I would receive my infusion (not obvious due to location upheaval due to COVID-19.) I could see from his email that he was not a big, bad bureaucrat, but a nice person who was doing his best in a challenging situation.
I followed up with Dr. X a week later and found out that there were just 1-2 small hurdles, and that I would be hearing from Dr. Y soon. Then Dr. Y told me that the drug has been shipped and it will be ready for me!
Yesterday, I showed up for my infusion of the second choice drug that we would use till IMMU 132 was available. It turns out that the second choice drug did not work. So, it was time to find IMMU 132 – we knew it had been sent to someone in our health system. Would I be willing to hang out while they track it down? Hell, yes.
So I waited for a few hours and someone hand-delivered IMMU 132 for me. My nurse told me that if it hadn’t been for my self-advocacy, I wouldn’t have gotten in it. It is amazing that within a few hours, we were able to make a treatment change in light of all the back-ups caused by COVID-19.
Also, IMMU 132 now has a name – TRODELVY – and it just gained official FDA approval. So if you have metastatic triple-negative breast cancer, it may be an option for you. If your doctor does a lot in metastatic triple-negative, he/she will know about this drug. If this is not your doctor’s focus, I recommend that you educate him/her so it can be an option for you. Also, this drug is showing promising results in a trial for ER+ so it is one to keep an eye on!
This post is dedicated to my friend Alicia Neubauer, who recently passed away from metastatic triple-negative breast cancer. Alicia was a fighter for everything that is just and right in this world. She fought to receive the drugs that she needed. Her husband, Eric, and I believe that Alicia is here by my side fighting with me. Alicia was gone too soon but inspires me to stand up and be heard. If ever you need help getting a drug you need, I will try to help you, and I know Alicia will be working behind the scenes to inspire and guide me.
Editor’s note: This article was published on May 27, 2020. Further developments in what we know about COVID-19 are continuously emerging. For more information about COVID-19 and strategies for coping, visit Self-Care in Uncertain Times.
Editor’s Note: We are extremely saddened to share that on Friday, April 9th, 2021, Alyson Tischler passed away. We know that Alyson’s advocacy efforts continue to reach many. She will be deeply missed.
Caregivers: Do you practice self-care?