Social Distancing

For the two years since Brent died, I have been trying to find my place in the world.  More accurately, I have been trying to find myself, because I do not recognize this life.  It  is so radically different from what it once was.

For many years, I found my identity primarily as a mother, advocate and caregiver. I was a fixture in our local hospital, living there with Lauren and Brent during their various cancer treatments.  Beyond those walls, I was always looking to expand my scientific contacts because I never knew who I would next need to help my children.  I had become accustomed to the regular and repeated medical crises that would emerge.  I became somewhat numb to living desperately close to the edge, in ways that most parents could not possibly understand.

I wrote faithfully in our CaringBridge, giving medical updates and describing what I felt. These entries were always honest, but often incomplete.  I could not fully articulate just how hard some things were.  Nonetheless, our family received unbelievable support throughout these years in a multitude of ways, which often moved me to tears. I was comforted by the kindness of our extraordinary community.

Nights in the hospital were the worst.  A life of interminable waiting and medical problem solving seemed to stretch out in front of me (and indeed, this went on for many years) When sleep would not come to me, I would often read words of encouragement online and somehow feel less alone. The RamerNation made a life within these parameters, making the best of our less than ideal circumstances.  We thought creatively, tried to find opportunities to expand our children's narrow world and always sought the upside.

And then it all ended, most abruptly.


Since then, I have written only sporadically, retreated socially, and tried to find a place where I can be fully honest about the impact of this experience. But even among my closest mutant friends, I find that I maintain a certain distance.  They certainly understand the stress of cancer and repeated trauma.  They have all experienced loss, but fortunately within this small circle, not the loss of a child.  With LFS, losing a child is not a theoretical idea, but an insidious fear that crawls into your brain every time scans roll around.  So, it felt especially wrong to continuously wave the specter of that very real possibility in the face of friends that I love. We all try to protect each other.

I enrolled in graduate school, beginning a Masters in Public Health program.  I continued with my advocacy efforts to change systems that I knew should be fixed.  I expanded my Rolodex of contacts which had been focused on physicians and scientists to include policy makers, elected officials and like-minded advocates. But in between these efforts, I have been mostly quiet, and mostly alone. I have tried to heal the brokenness.

I have stilted conversations with people that I run into.  I find small talk at social gatherings to be a nightmare, because benign questions that are commonly asked of women my age require answers that are filled with cancer: How many children do you have?  Followed by, What do you do for work?  I have not crafted responses that are appropriate for a party yet, and navigating these interactions is exhausting. I often beg off, despite how socially engaged I once was.

I went to counselling for a time. I have looked for support groups for bereaved parents, but have not found a true fit.  I keep pushing forward, but I feel the punishment of Sisyphus, as each fresh day begins by picking up the same burden.

At the end of January, I attended a conference in DC about Expanded Access.  A speaker apologized during his presentation that he would need to leave in the middle of the panel discussion because there were some problems happening in China.  Sure enough, his phone alarm went off, and Dr. Anthony Fauci walked out.  I had no idea that I would change my facebook profile picture to his image, only two months later.

I watched this pandemic approach with the same apprehension that I felt during cancer. Alex had a cough when he came back from Ann Arbor and he went on to develop a fever of nearly 103. I dug through my zombie Apocalypse medical stash and found an open box of masks for him.  After advocating for him to be tested, I waited anxiously for his Covid results. People that we know are becoming infected, and some that we care about have died.  I described it to my mutant friends the other day:

"It is just so familiar...this feeling that I have. It is like a slow moving train and we are Penelope-tied to the tracks. Will it stop before we are crushed? I felt this way during Brent's osteo, wondering if his long surgical delay from chemo would result in lung mets...and during transplant when we had to wait holding our breath to see if it would work, and again with relapse before the DLI when Brent went without any white count for months--terrified that he would get infected....and during necrotizing fasciitis--those days in the ICU on a vent, and months later, when he didn't wake up for a week with the acute kidney injury, and with the acute respiratory distress he had earlier that admission....and less than a year later, when he was on a vent again...waiting for him to get well enough to receive those cells. It all has kind of gotten to me...all the waiting that I have done in my life for things that were beyond my control. So many times, it worked out. Things have stopped working out for me, it feels like. Just been a hard day today"

I am very glad to report that Alex has tested negative, because I have had my fill of ventilators and hospitals. It has been rather triggering for me, truth be told.  Furthermore, a positive result in Alex would carry huge implications for my mother who lives with us, and uses oxygen. Dan still goes to work at the VA hospital every day, so his risk- and ours- remains greater than those in true isolation, but for now, I can breathe a bit easier. (That was not intended as a snarky pun, but if you need one to break the stress, there you go.)

Mandated isolation for Covid has not had a profound an impact on me, since this had become my baseline, but it has greatly impacted my children, who have been forced to isolate far too often in their lives.  It feels cruel to deny them the opportunity to see friends, especially Lauren who was looking forward to a strong finish to her high school experience. She is now doing her final semester as a senior remotely.

Again, we have no choice.


I recognize that my experience with persistent fear, heightened uncertainty and unnatural loss, the things that made me feel so separate from most people, are becoming common to everyone in this post-Covid world. Speaking from across the street to neighbors while walking the dog, and seeing Facebook posts confirms that those who could never imagine living with such things, are doing just that.

So today, I feel that I will not be bringing the world down by sharing some of my feelings, because, most tragically, the world has begun to truly understand them.  The same extraordinary community that supported us for so long, and the people who said with honestly and compassion, "I cannot imagine!" have begun to experience a bit of the fear, had a taste of uncertainty, and is now in isolation.

I wish so very much that I could offer them even a fraction of the support and encouragement that we experienced for all those years.  We may need to be isolated but we don't have to be alone. Hang in there.

Stay home.  Stay safe.  Be well.

Much love,
Ann

The fullness of a week in Washington

It has been a very full week, one that began with funeral services on Sunday for a cancer friend.  During our last stint on the oncology unit in late 2017, while Lauren was in treatment for osteosarcoma and Brent was trying to bridge to his 18^th birthday in order to be eligible for an adult clinical trial for relapsed leukemia, little Viv and her family lived in the hospital with us.  She was receiving a bone marrow transplant for her own aggressive leukemia. This tiny child brightened those dreary halls and filled a room with joy and hope, just by being there. Vivian Rose was beautiful, sassy, and adored by all.

Last week, she died just hours short of her 4^th birthday.

 

I drove to Washington DC on Monday, to attend an Expanded Access Summit at the National Press Club with Viv and Brent heavy on my heart.  For three days, I listened to presentations and talked with folks from FDA, pharma and research institutions about the challenges found in balancing the competing interests of safety and opportunity for patients.  There was thoughtful discussion about the practical limitations that small start-up biotech companies face.  We analyzed the risks and costs that make it difficult for new companies to provide drugs to patients outside of clinical trial.  I recognize and appreciate these considerations. They are the very issues that brought me to this conference last year.  

I was most encouraged when Janet Woodcock of FDA endorsed a trial design that contained an ‘Open Access Arm.’  This additional arm, which mimics expanded access/compassionate use, would provide much needed “Real World Data” to researchers.  The traditional arm (which has more restrictive inclusion criteria) would better answer questions about product safety and side effects. The data from a more representative cohort could guide countless physicians who wonder how a drug will affect their much different patient after it is approved. The experiences of patients in the open access arm would inform the decisions for patients who have similar comorbidities. Currently, this more complicated type of patient is seldom seen in clinical trials. 

As an advocate, I have long called for this dual arm trial design, which might have provided opportunities for Brent and Viv, who did not fit the narrow criteria of clinical trials that existed while they were alive. I believe that there are things to be learned from every willing patient.  We should not squander that opportunity.

I still worry about Lauren, who becomes more complicated as time goes on.  As she approaches 18, I am less concerned about her age as the criteria that limits her options, than her extensive cancer history (especially the brain tumor that she had at age 9 and again at 12). Regardless of how well she is doing, this single factor would disqualify her from participation in many clinical trials. I am working to change these limitations for her, and patients like her. 

I celebrate Jane Woodcock’s call for this alternate trial design and would urge that data derived from the ‘Open Access’ arm to be given less weight in the approval process, similar to the consideration that expanded access data receives, so as to not negatively impact the application.  I hope that the signal from FDA endorsing this trial design will be widely adopted by pharmaceutical companies. However, given the costs associated with expanding clinical trials in this way, it will likely take more than just a suggestion from FDA for them to incorporate this idea into trial design, even with the benefit of having trials accrue faster.

Creative discussions are critical for change, and I certainly witnessed some of those during the conference early in the week.  I will applaud progress, even when it takes time.

There was more good news.

On Thursday, I was fortunate to meet with a member of Sherrod Brown’s staff, after he was called to Senate impeachment hearings.  I was encouraged by their effort to develop a clinical trial navigation program, as well as their transparency and continued follow up with me about the process.  I am excited for the proposed system which would educate patients about clinical trials, offer medically appropriate opportunities and partner with social work to help connect patients in need with non-profit organizations to manage the other obstacles to participation (travel and housing). Again, I believe that helping individual patients to participate in research will help advance science overall.  I look forward to reading the legislation when the policy review process has been completed, perhaps as early as next month.

After this meeting, I sat outside of Union Station, enjoying the sunshine with a cup of coffee.  A rather disheveled man holding a paper map approached me asking, “Where is the monument?” I tried to imagine what monument he meant, since there are so many in DC.  I took only few steps toward him, to try to help him navigate his map and find his destination, before a friendly local jumped in, helpfully showing him the way.  “You are going to want to take Louisiana to get to the Washington monument….”  I watched the two men and smiled. This seemed like a fine analogy of what I am working toward in clinical trials, the well informed local, helping this lost tourist find his way to the must-see monument.

The next day I drove back to Ohio, pleased with this overall progress.  But there was even more to be hopeful about.

I stopped in the afternoon to take a call with the Coalition Against Childhood Cancer, to review FDA draft guidance for the Pediatric Research Equity Act, which mandates that pediatric clinical trials be offered for new drugs that act on molecular targets that are found in both adult and pediatric cancer.  I have watched the pediatric community come together and coordinate their efforts in order to bring about this much needed change.  

The interpretation of this law by FDA has been strongly supportive of progress in pediatric cancer.  This legislation (and the FDA's interpretation) according to draft guidance would have eliminated the delay that Brent experienced, and would have required that there be a pediatric clinical trial option for little Viv. 

We can only move forward and try to make things better for others. 

I am so grateful for all those who have worked together to address the needs of the most vulnerable patients. It is a complicated problem, requiring cooperation between many groups: academia, industry, regulatory and patient advocacy.  I am grateful for the opportunity to be part of this effort, which honors Brent, serves Lauren and consequently, is terribly meaningful to me.