top of page

Clinical Trial, or Criminal Trial?

So, a lot has happened since I wrote about two weeks ago.  

Since I arrived in Houston 12 days ago, pretty much every functioning part of my body (as well as a few non-functioning parts) has been scoped, probed, poked, prodded and in some cases, twisted - as part of 13 separate procedures to establish my “baseline” before entering the clinical trial.  I can honestly say that I have never felt so exhausted in my entire life.  I have spent these last two weeks running to appointments and procedures (sometimes three a day) across the massive MD Anderson medical industrial complex that sprawls across the whole city of Houston.

I told the clinical trial coordinator yesterday that I have both test fatigue and test result fatigue.  Every single test result is a nail biter, as it is up to the clinical trial sponsor to decide what the tolerance level is for any test result that strays from “normal.”  Yesterday was spent doing two “re-tests” because there were a few things in the original tests that the trial sponsor wasn’t happy with.  Even on the re-test, there were still some concerns, but the deviations were largely explainable by recent events, so the trial sponsor is ok with proceeding, which means I have been accepted into the clinical trial (but wait, as always, there is more to the story).

As such, I will check into a hospital room at MD Anderson Cancer Center tomorrow (Sunday) afternoon to get settled, and begin blood collection, vital signs, etc. in anticipation of starting the first infusion on Monday morning.  I did receive a pleasant surprise in going over the hospitalization schedule with the clinical trial coordinator yesterday.  I was under the impression that once I checked into the hospital, I would be hospitalized until I was cleared following the third infusion, which would be three weeks from now.  

As it turns out, if I tolerate the treatments well and don’t exhibit any signs or symptoms of “cytokine release syndrome,” I can be hospitalized each Sunday and be checked out of the hospital each Wednesday, allowing me to leave the hospital environment for the other half of the week.  That has its own obvious benefits, and it also allayed the concerns I had about the ability to keep up with my job in the meantime, from the friendly confines of a hospital room.

So, back to this clinical trial acceptance process.  It has been amusing, enraging, exhausting and at times, has felt a bit like being cross-examined by a district attorney.  I did not have a full appreciation of how your medical records follow you around through life until I went through this clinical trial acceptance process.

During the prelude to clinical trial acceptance, I had already spent many hours on the phone going through my medical history.  Like LOTS of hours.  This past Wednesday, only days before the scheduled pre-trial hospital admittance date, I received a phone call from my slightly breathless clinical trial coordinator at 8:30 p.m.  She said she needed to clarify a few things on my medical record before sending my information to the clinical trial sponsor.  There was a palpable sense of urgency to the call, given the tight timeline for acceptance and the beginning of the trial.  I was frustrated that we had to spend even more time on this, but I knew that I wasn’t the one holding the cards, so I rolled my eyes, sighed a bit, sucked it up, and said “ok, what do you need to know?”

This call went on for at least another 90 minutes and I was amazed by some of the questions.  One of my favorite exchanges went something very close to this (“CTC” refers to my clinical trial coordinator):

CTC: “So, how long have you had asthma?”

Me: “I’m not sure how to answer because I don’t have asthma.”

CTC: “But it says here that you have asthma.”

Me: “Again, I’m not sure what to tell you but I can tell you that I don’t have asthma.”

CTC: “So, do you have any idea why your medical record says that?”

Me (after thinking about it for a minute): “The only thing I can think of is that when I was a very young man – at least 30 years ago - I would get annual bronchial infections.  My family doctor eventually referred me to an allergist to try to figure out why.”

CTC: “So, did he tell you had asthma?”

Me: “No, but he did test me for allergies, put me on allergy shots for many years, and documented that I had ‘chronic allergic rhinitis’.”

CTC: “What is chronic allergic rhinitis?”

Me (now getting frustrated): “Whether most people that live in the Ohio River Valley know it or not, they likely have chronic allergic rhinitis.  It’s basically “allergies” - runny nose, watery eyes, coughing, sneezing, and feeling like you have a cold all spring and summer long.”

CTC: “What do you do to manage that?”

Me: “I take a 10 mg tablet of Claritin each day.”

CTC: “So, you don’t have asthma then?”

Me: “Nope.”

CTC: “OK, I’ll explain this to the trial sponsor, but they may have more questions because your medical record says that you have asthma.”

Me: “I’m not really sure what else to say at this point.”

This same type of back-and-forth went on over a documentation that I have “irritable bowel syndrome,” which I don’t, all due to a visit a gastroenterologist more than 30 years ago, with no findings (so “irritable bowel syndrome became the default diagnosis).

This also continued with discussions of the documented “traumatic brain injury” from a skiing accident in early 2000 that turned out to be a concussion and an eye socket fracture, with no long-term negative effects or structural brain issues noted or detected. 


I was also asked about when my doctor first told me that I had “metastatic castrate-resistant prostate cancer.”  I said that despite knowing that is how my cancer is classified, none of my doctors – and I have many – have ever said to me that I have “metastatic castrate-resistant prostate cancer.”  She said, “this makes things tricky, since we really need to establish that on the timeline.”  I said – “once again, I’m not sure what to tell you.”

Getting into a clinical trial, and particularly a brand-new clinical trial, is not for the faint of heart, but there may come a time in your life when it is required or represents your best shot at spending additional time here on Earth.  Based on my experience, it requires the right combination of compliance, diligence, patience, humility, and more patience, all of which needs to be supplemented with a heavy dose of sheer determination.   

I wonder how many other people there are out there that don’t realize the implication of some of these stray items that become part of their permanent medical record.  After 90 minutes of frustration working through these “clarifications” the other evening, the same diagnoses still appeared in my chart two days later when I met with my nurse practitioner, when we had to go through them all again.  Seriously?  

This all becomes particularly problematic when your disease journey causes you to move in and out of multiple medical systems, where you must supply the same information, and try to correct misinformation in your medical record – over-and-over-again.  Despite the billions of dollars that have been spent by hundreds of health systems across the country on the vaunted Epic electronic medical records system, it does not integrate that information nearly as well as a patient might hope, especially when the chips are down, and quick action is required.

Each year, Diana and I receive a report from the Social Security Administration showing what our monthly social security benefit would be if we were to take retirement at various points in time.  This report also lists the maximum number of wages each year that this calculation is based on.  Despite moving our residence multiple times, getting married, and changing jobs a countless number of times, I have never found an error in this report.  It’s fascinating to me that this information is driven off one number, issued to you at/near birth, that follows you around through life.  This social security numbering system was developed by the oft-criticized U.S. government, with the first social security numbers issued to people in 1936.

After going through all of this, it occurs to me that there is not an equivalent “medical records number” when it comes to your health… a single number issued at/near birth that allows your medical information to follow you through life.  That way, patients would not be expected to scramble to answer these types of questions when time may be of the essence and - not to over dramatize - but when their life might be on the line.  I am not naïve – I know it may not be seamless, especially if one medical professional does not agree with the conclusion of another, but there must be a way to do this for the purposes of a workable medical record that is consistent across medical systems.

Perhaps there are practical considerations beyond my level of comprehension, but I would submit that most any argument against the ability to do something like this would have been met with a similar argument back when the U.S. government was contemplating issuing “social security numbers” for the first time.  Somehow, saddled by bureaucracy, and using comparatively primitive computing technology (i.e., virtually none), the U.S. government managed to pull it off.  Now, ironically enough, your social security number has since become an integral part of your medical record.  It feels like we as a country should do a better job at this.

Until next time,



bottom of page