Hi folks. It’s Friday, two days after we returned from Sarah Cannon in Nashville, where we had hoped I would be starting a new trial. Well, unfortunately, Tuesday wasn’t such a good day for Kim and me. When we collapsed into bed at the day’s end, Kim said, “Well, that was an ‘oof’ day,” with which I agreed, though ‘oof’ doesn’t quite capture the life-and-death urgency with which we are living these days, but it does say something about how we’re trying to stay light and hopeful as we wait for a new therapy which will, hopefully, slow the progression of my disease. The short story is that I was disqualified from the study that I was supposed to begin on Tuesday. So, I’m still off treatment, and my tumors are presumably still growing. Oof.
If you’re unfamiliar with how clinical trials work, and I’m assuming that most people aren’t because there is no reason to be. From my observation, there are basically two sides to the system, “Research”, which works with the drug companies, the cancer facility, and the patients for enrollment in a study, and “Clinical”, which are the medical people who handle the drugs and the patients. I have had nothing but great care at Sarah Cannon Cancer Institute in my 2.5 years as a patient there, and, more recently, I have the highest confidence in the Research Coordinator who has worked with me to identify possible trials, screen me for candidacy, and schedule all of the necessary tests to ensure that I am truly fit for the therapy and that the “Sponsor” (i.e. drug company) gets the data that I begin treatment. From what I’ve seen, this is no easy task, with a dizzying number of specifications involving each study that must be thoroughly scrutinized to ensure that no detail is overlooked.
The Clinical Trial system is extremely complicated, and, as I’ve described before, there exists a clear tension between what is best for Medicine and the future patients who might benefit from a drug brought to market because of strict and rigorous medical science, and the patients with names and families who might benefit today from a drug during its testing but whose changing health may alter their qualification for the study.
Since Kim and I watched this movie with our son, Owen, a couple of weeks ago and because I have a quote from the film that is fitting for the incident on Tuesday that led to my being unable to receive treatment, it seems reasonable to call the Clinical Trial system “Weird Science”. Why not?
If you’ve seen the movie, a John Hughes film, you can’t forget it, because a young Kelly LeBrock as Lisa, a beautiful supermodel woman, brought to life in Frankenstein-esque manner by a couple of nerds and their computer, and who possesses mystical powers, is a pretty enduring memory. Well it was for me, who first watched it at the age of 15. My son, Owen, though, may have missed the enduring qualities. His primary comment was that the movie was unrealistic. He’s 14.
Anyway, towards the end of the movie, the two boys are trying to earn the approval of two other boys by creating for them another female, supermodel, superpower being. It is shocking because these two popular guys have been bullying the nerds who created Lisa throughout high school. Only, the didn’t create a clone of Lisa; they wound up creating a full-size, genuine missile that lodged itself in the house as if it was a silo. Upon discovering what the boys were up to, Lisa admonishes them for trying to earn popularity by pleasing others and then closes with, “Well, in your race for power and glory, you forgot one small detail.” One of the boys, Wyatt, responds, “We forgot to hook up the doll.” Instead, the probes lay unoccupied atop a magazine with a missile on the cover, which led to the little detail of the formation of a giant rocket in his room.
Well, we’re not seeking power and glory, but we are racing against time to find a new drug that can effectively slow, stop, or kill the cancer in my body. And, unfortunately, the Research Coordinator missed one small, exclusionary detail during screening: proteinura. I’m not going to explain what that is. Suffice to say it is a measure of the “complication” of my urinary system.
On Tuesday morning, the clinical nurses analyzed test results from blood and urine to determine if I was of good health to be dosed with the drug. Sadly, they found that my “complication” was measured as “2+”, which is beyond the allowable value for the study. So, “no drug for you!”
It was hoped that we could obtain an exception from the sponsor, so the Research team at Sarah Cannon, including my oncologist, made phone calls with the researchers at Pfizer to plead my case. I even heard that my doctor referred to me as “fabulous,” which I’m not sure is relevant in the world of Weird Science. Anyway, getting all of the white coated smarties on the phone took a while, and, since I had been fasting, they sent Kim and me to lunch.
I may be wrong about this, but I feel like I experience strange events or circumstances with a greater frequency than the allowable value to attribute as mere coincidence. What I’m about to describe isn’t the greatest example, but, following my previous post where I called out Chick-fil-A and their definition of “extra pickles”, this brief story is at least comically coincidental.
Nashville has become known for a preparation of fried chicken known as “Hot Chicken.” It is very popular and is increasingly showing up on menus everywhere. Well, there is a chain in Nashville called Hattie B’s whose specialty is Hot Chicken, and, since we’ve been traveling to Nashville for over 2 years and had yet to try this indelicacy, we plotted our lunch course to the Hattie B’s down the road.
In an ordering episode reminiscent of mine and Kim’s trip to the Murfreesboro Chik-fil-A a week earlier, I threw the cashier a curve-ball by asking for a pickle. Maybe it was the way I asked, or the fact that I asked after he had finished my order, but, instead of getting a pickle spear, I got a cup of pickle slices. THIS, Kim and I noted, is what extra pickles looks like. We thought maybe this pickley coincidence was an omen for the outcome of the request for exception. In hindsight, how could we have known whether the omen was good or bad? Pickles are sour, yes, but the omen was decidedly neutral.
Anyway, we came back to no answer and left with a familiar orange jug into which I was to urinate for 24 hours, and then we’d get an answer.
So, Kim and I worked and waited, I did my duty, and I dropped the container off at 9am for it to be analyzed. This took about 5 hours, time Kim and I spent at a coffee house called Fido’s near Nashville. Great food and espresso.
Ultimately, we were called in to be screened for yet another trial, for which 4 spots had opened the day before. Wisely, the Research Coordinator grabbed a spot for me just in case. I gave more blood and lay down for an EKG, and by 2:30 we learned that the Sponsor said no. Fabulous I may be, and my proteinuria may be stable and my personal baseline, but it was too much for the folks at Pfizer.
So, here I sit, in limbo again, facing more tests and rigmarole for a new study. Worn-out, frustrated, and agitated I am, but I am so thankful that these clinical trials are available and that I have a team of researchers and clinicians who are fighting for me to help me find a treatment that will work.
Next week, we’ll head back to Nashville for another MRI and CT scans and whatever other screening test may be necessary (any test over 4 weeks old must be repeated for a new study). If all goes well, I’ll begin the new treatment the following week, around March 6, before we take our son to New York for a long weekend and fittingly close to the 6-year anniversary of this cancer battle.
We appreciate your prayers immensely.
I have written about a particular nurse, Kelly, in previous posts and in my book (Two Stories) who has made statements that hit me for some reason as if they were prophetic. Some time ago, she told me, “God’s not through with you yet.” Some might dismiss such a statement as foolishness, and I agree that one should be careful with such proclamations, but she said it to me with sincerity and love and innocence that was personally believable. What can I say? Sometimes Christians speak at a spiritual level about mysteries with factual confidence.
Yesterday, Kelly spoke again, this time via instant message. She said to me, “I’m really sorry it didn’t work out. I know you feel like time is ticking. Not to sound cliche’, but God must have a better plan. We are staying hopeful and trusting, Mr. Weatherly.”
That’s a boom. That’s kindness. That’s encouragement. Prophecy? We’ll see. I told her that an audible sigh had been released from Bishop, Ga. I also told her that I hope that God’s good plan meant that my spot on the study from which I was disqualified is given to a cancer patient who needs it more than I do at this time.
It is true, as my friend Billy pointed out, that I’m in a pickle right now. Waiting is difficult. Not knowing what is happening inside you is brutal. Feeling the impact on family and friends of our frequently being away from home and our four children in high school is killer. But we all must keep fighting, not just me, not just the patients, all of us, especially you caretakers.
I was on my knees this morning praying for people who are going through some very difficult circumstances. My knees hurt before I could finish the list, which could go on forever. But I know there are many doing the same for me.
More news next week. Thanks for reading.