White House Update
Gee Whiz! Six weeks have passed since I last posted, and an awful lot has happened since, so this might get a little long…! But in short, things seem to be going remarkably well…!
First, here’s the medical stuff… since my last post, I’ve returned to San Diego twice – first to receive my third and final vaccine inoculation, and then in order to follow-up three weeks later with a CT scan. The bottom line is that I continue to enjoy excellent health with no overt symptoms of disease. I’m in San Diego at the moment, where today I expect to get the results of the Friday’s CT scan and we’ll know something more about the status of my cancer.
Just to summarize my current treatment, I have now completed the three planned inoculations of a completely personalized neoantigen cancer vaccine. I was fortunate enough to get this vaccine manufactured and administered through a very small Phase I clinical trial being carried out at the University of California San Diego. In addition to receiving the vaccine, the 10 trial participants are receiving regular doses of Pembrolizumab, the anti PD-1 checkpoint inhibitor that I had already been treated with for 14 months as part of a Phase II clinical trial in Connecticut. The good news about my condition recently, is that my blood markers, CEA and CA 19-9 have declined pretty dramatically. CEA has been dead center within the “normal” range for weeks now, and CA 19-9 has been slowly but steadily trending down and is now almost within normal. It’s not clear what this means, because there just isn’t much data available on the expected response to combinations of neoantigen vaccines and check-point inhibitors, but what data I’ve seen gives the impression that it can take a while for a response to kick-in (up to 12 weeks anyway), so tumors sometimes continue to grow initially, before showing any signs of shrinkage (and of course, it might not work at all), but if the CT news I get later today first appears to be discouraging, I won’t worry much, since it might just be early days and a more positive response may be yet to come.
In addition, the limited early data from Margaret Wu’s comparable trial at the Dana Farber seems to indicate that once a positive response begins, it tends to deepen in a linear way over an extended period of time. Positive responses so far seem to be durable… so there are good reasons to be hopeful and encouraged… no matter what Friday’s CT scan reveals.
Nonetheless, there are a couple of negatives regarding participation in this trial. The first is the need to repeatedly travel so long a distance at my expense… and the second is the side-effects of the Pembrolizumab. About 30% of long-term Pembro users develop side-effects which can be serious (like the colitis that’s been bothering me). In order to control it, I take prednisone, and when I do, the infusions of Pembrolizumab have to be suspended. That’s the situation at the moment… I’m on prednisone, so no infusion with Pembrolizumab has been forthcoming on this trip. And what makes this especially frustrating, is the overly bureaucratic and restrictive clinical trial system, where study protocols are too often unreasonably inflexible. As things stand in my case, if I want to continue with Pembrolizumab under the trial (which I do), I am expected to travel to San Diego at my expense every three weeks to receive a Pembrolizumab infusion which could much more conveniently and inexpensively be administered in Central Vermont. Unless this protocol requirement can be amended, I may be forced to withdraw from the trial and see if I can’t access Pembrolizumab some other way. How sad that society should bear the cost of an early trial departure for such a ridiculous reason!
Anyway, Mia and Deborah were able to accompany me to San Diego for the final infusion, and we had a wonderful day in the desert enjoying the extraordinary bloom this year.
On another front, I had the good fun and fortune of being called somewhat unexpectedly to the White House to give a short talk about my response to my terminal cancer diagnosis. My participation was at the invitation of Dr. Gil Alterovitz, a bioinformatics professor at the Harvard Medical School. The occasion was the presentation of the results of a Federal Health and Human Services Task Force Gil has been heading up for the purpose of accelerating Artificial Intelligence and Big Data applications in medicine in order to improve patient outcomes. He had previously invited me to tell my story to his group, and they apparently found it instructive and inspirational. The next thing I knew he asked if I wanted to participate at the White House, and briefly address about 75 senior government officials and technology experts. The event was the culmination of a 14-week ”TOP” Tech Sprint for Health Innovation program to provide leadership and direction for innovation and digital solutions across HHS — https://www.hhs.gov/cto/blog/2019/1/17/top-health-tech-sprint-unleashes-the-power-of-open-data-and-ai.html
My address was slotted into the program on Artificial Intelligence approaches for facilitating an experimental therapy ecosystem. The program asked how can we do better by leveraging standards and emerging technologies. The team’s mission: Create digital tools that help in finding experimental therapies for patients, and vice versa.
In subsequent remarks, Dr. Alterovitz had this to say about my talk…
“We heard an inspirational and thought-provoking talk by Stephen Aldrich at the White House. I believe that pioneering path he took is what the future of clinical trials will become. Just as flying was rare in the mid-20th century and eventually became standard model of operation in just a few years, so to can these personally designed therapeutic trials based on personal big data and related criteria. Much of the work we have seen via the AI ecosystem teams is directly applicable in this paradigm; I encourage us to think about what will bring this reality faster going forward as we plan next steps.”
Here is the text of my remarks to the group. (And I know it will come as a surprise to many of you who know me well, I was one of the very few who kept within my allotted time!)
MY ENTREPRENEURIAL RESPONSE TO TERMINAL CANCER
Remarks by Stephen C. Aldrich
The White House
February 28, 2019
My name is Stephen Aldrich. I’m a 63 year old retired entrepreneur living in Stockbridge, VT. I’m here today to share the story of how I responded to a fatal cancer diagnosis. It’s a story about a regular person gaining control over his fundamental health data – including the raw sequence data for his whole somatic and cancer genomes – and how he used this data to access a fully personalized precision cancer therapy. It’s my hope that the story inspires more and more “regular people” like me to take charge of their data.
The story begins two years ago, when I was diagnosed with metastasized adenocarcinoma of the esophagus. There is no known cure for this disease, and folks who get it are generally expected to experience a steady decline in health culminating in death not long after diagnosis. The strictly palliative first line standard of care is a chemotherapy known as “FOLFOX”. Unfortunately, the longer you use it, the less effective it becomes, and the more a patient’s intolerance grows.
Given these facts, I decided to reject the palliative standard of care in order to pursue new, experimental treatments that might hold some promise of delivering a complete remission. To do this, I knew I needed information on the genetic makeup of my particular cancer. I asked my treating oncologist at the Dana Farber when I could get access to the results of the genetic profiling I knew they were likely to do on my tumor, and was shocked when he told me the Dana Farber had no obligation to share that information with me. I was greatly disturbed by this news, since if there was a solution, I believed we’d find it in the data… I wanted high-quality whole genome sequencing done for both my healthy and cancer genomes, and I wanted access to the underlying data. To get this, I went outside the Dana Farber and enrolled in a Comprehensive Cancer Study being sponsored by Human Longevity Inc. (HLI). Study participants were contractually guaranteed access to their raw sequence data. Once I had the data, I used it to identify a Phase II clinical trial in Connecticut testing a combination of two promising new immunotherapies — Pembrolizumab and Epacadastat — that seemed well-matched to my genetically unique cancer. I was treated with this combination of drugs for 14 months. During that time, I enjoyed overall good health and had no symptoms of overt disease.
I also used my whole cancer genome sequence data to commission the design of a completely personalized neoantigenic cancer vaccine (NCV) from the Center for Genomics and Transcriptomics in Germany. I assumed that it would be easy to transfer my sequence data files from HLI in California to the design firm in Germany, but this turned out to be much more complicated and time consuming than anticipated.
In the end, a hard drive containing almost a terabyte of data had to be Fed Ex’d from HLI to Germany. The difficulties I encountered in moving my data convinced me there had to be a better way… When I couldn’t find an existing solution, I decided to build a secure, user-friendly cloud-based facility for patients to store, analyze, and enable collaboration around their fundamental health data. The result is “www.myCancerDB.com” – a new company owned by late stage cancer patients.
In mid-October of 2018, I decided to voluntarily leave the Connecticut trial in order to be treated with the vaccine I’d commissioned and tested at the Center for Genomics and Transcriptomics in Germany and the La Jolla Institute of Allergy and Immunology in San Diego. I received my first injection on January 15th of this year, and my third and final injection will take place this coming Monday. In the past, the only way patients in the United States could legally access such personalized vaccines was through enrollment in an FDA sanctioned clinical trial. But recently, new paths have opened up via “Right to Try” legislation, and I am pleased and honored to recognize Laura McLinn who is in the audience with us today. Laura, whose son Jordan has a life-threatening illness, is one of the courageous patient-advocates who is most responsible for bringing “Right to Try” into reality.
Finally, because the underlying technology for creating personalized vaccines is now widely accessible and quite mature, I’m hoping my story will help accelerate availability to this and other equally promising treatments. This is also the goal of myCancerDB.com. All cancer patients should have the benefit of accessing such treatment options! For more on my journey, please visit my blog at www.stephenaldrich.com
Here is some of the press coverage of the event… The last link mentions me.
There is also a long article featuring my cancer story now scheduled to be published soon in a major national magazine. That article will, in part, be about the launch of myCancerDB.com which is steadily progressing. We have recently added a couple of new founding members, and have launched an initial, placeholder website, www.mycancerdb.com. Please check it out and leave a comment letting me know if you think it makes our purposes clear, and/or what we should do better…
Finally, more than ever I believe my healing is as much about right living and prayer as it is about anything else — so please keep those prayers coming! The universe is interactive!
REMEMBER, LOVING ONE ANOTHER IS THE MOST IMPORTANT THING!