Going postal; or, 39 vials of blood, is that all? 39 vials of blood?

We’re talking small

Before I get into all the gory details of everything that transpired at the NIH clinical trial last week, I wanted to share my unique lodging experience at the Bolger Hotel & Conference Center, which was originally constructed in the early 1980s as a training facility for U.S. Postal Service employees, and recently taken over by the Dolce Hotels and Resorts group. Given that hotel rooms in the vicinity of the NIH are at a premium in terms of both availability and price, and that the lodging stipend extended to trial participants is a modest $50/night, I felt very fortunate to happen upon this hotel, given that it’s a mere five miles from the NIH yet runs barely a few bucks more than the stipend amount. Plus, it’s located on 83 acres of private forested grounds with a 1.5 mile walking/jogging trail, two fitness centers and a pool, and–most importantly–complimentary wired and wireless Internet access.

So what’s not to like? Well… because it’s more of a conference center than it is a hotel, it was lacking in a lot of the typical amenities common to most hotels. Like employees, and room service, and vending machines, and a place to purchase goods and sundries, and a mini-fridge or microwave in the room; those sorts of things. Perhaps that’s because there was literally no room in the room to accommodate even the smallest of appliances–or anything else for that matter.

I’m certainly not the “road warrior” type who’s stayed in hundreds of hotels as a function of my job, but I have done quite a bit of traveling over the years, and I have to say, I’ve never seen a hotel room as small as this one. It was essentially the size of the bed (a double), with just enough space added on either side to be able to get in and out of it. There was a padded desk chair and a very shallow desk at which to work, but it was virtually impossible to move the chair back far enough to get up without being blocked by the foot of the bed, so I had to crab-walk the chair sideways towards the bathroom in order to escape.

As the extremely polite and professional front desk clerk informed me, since the rooms were originally designed to house hundreds of postal employees for training purposes, the emphasis was on efficiency, not on spaciousness or comfort. Given that I wasn’t there for a vacation, and that everything else about the place was more than satisfactory, I’lll just have to remember to request the room dimensions next time I’m ready to book my hotel for an upcoming clinical trial 😉 Come to think of it, maybe now we have a more definitive explanation for the phenomenon known as “going postal.”

The cGVHDetails

Officially known as the Chronic Graft vs. Host Disease (cGVHD) Natural History Protocol, the trial in which I participated began way back in 2004 and will continue until the investigators have seen approximately 600 cGVHD patients. Only one participant per week takes part in the festivities, so I was feeling very special as all the physicians, investigators and techs were totally focused on me for the entire four-day period. The schedule of tests and consults was extremely tight and allowed very little room for error, much less for eating lunch or returning emails, but everything needs to be completed in that period of time as they don’t want to be dragging participants back there for any do-overs. Besides, in the immortal words of Gordon Gekko: “Lunch? You gotta be kidding. Lunch is for wimps.”

Things started off less than auspiciously before I ever got inside the hospital; the NIH is a Federal facility and as such they are required to (very thoroughly) inspect every vehicle that enters, and of course mine is always filled with boxes and boxes of computer parts and audio cables and hard drives and all manner of tech paraphernalia that would have had to be taken out of the van and individually X-rayed by the security staff ;-( A very helpful member of their team suggested I simply back out, find a space on the street and walk in, which turned out to be my modus operandi for the entire week. Otherwise, my schedule would probably have blown before the trial even got started.

Speaking of the schedule, I was typically looking at, on average, three specialist consults and 2-3 diagnostic tests in the course of a given day. Fortunately everything took place inside the NIH Clinical Center building, which is unabashedly massive, but very well signed in terms of locating specific clinics and testing areas, and although there are 13 floors in the building (or perhaps because of it) the elevators were as fast as my hotel room was small. The Center is the largest hospital in the U.S. devoted entirely to clinical research, and nearly half a million trial participants have come through since it opened in 1953.

One thing that particularly struck me at the outset–and all the way through the gauntlet of tests and consults–was how polite, caring and helpful the specialists, techs and support staff were. Given that the NIH is a government facility, I have to confess that I expected to be confronted, at least in some instances, with the less than optimal attitude and effort all too often exhibited by your typical bureaucrat/government employee. Like, say, a U.S. Postal Service employee trained at a facility in a room the size of, er, a postage stamp… So you can all rest assured that, at least in this, your tax dollars are well served.

Another pleasant surprise was the degree to which the study was constructed to aid each participant with their current cGVHD issues and symptoms. I had assumed that for the most part the techs would be taking blood (26 vials on day #1 and 13 more on day #4) and administering diagnostic tests, and the specialists would be examining and quizzing me, in order to derive as much data from me as they possibly could for purposes of the study. Anything I could glean from the experience for my own benefit would be up to me in terms of taking careful notes and quizzing my tormentors at length whenever time permitted.

Yet in the course of virtually every test and consult, I was provided with all manner of unsolicited and highly personalized advice on the spot. Further, on Friday, Dec. 6th, the specialists with whom I met will assemble as one to “rigorously” review my test results, along with their own individual observations, and will then make specific recommendations to Dr. Strair, my lead physician at the Cancer Institute. I will also be provided with all my records and test results following their meeting, and they will recommend any applicable current clinical trials, as well as whichever studies may come along over the next 5-10 years that could potentially be of value, given my specific set of cGVHD issues.

Dr. Pavletic, the lead investigator, examined me on the first day and indicated that, based on his preliminary look at my history and symptoms, everything looks positive for me to eventually overcome this. His experience is that the average time to complete remission of cGVHD symptoms, to the point where no more steroids are required, is between two and three years from the transplant date. So now I have another target date to beat; since I was sprung from both my hospital stays much sooner than the docs or I expected, I’ll just have to get past this faster too 😉

Overall, I feel incredibly fortunate that I virtually stumbled on this trial while poking around online, and was able to schedule it almost precisely at the one-year mark, which dovetails very nicely in terms of getting a raft of “free” tests that I would have needed to undergo at the Cancer Institute this week. I do still need to receive all my childhood immunizations again starting next week, since the transplant basically wiped clean any immunities conferred on me by virtue of being immunized as a child, or by actually contracting a particular virus like the measles, which in and of itself confers immunity to that specific virus going forward. In short, I am now a tabula rasa–a blank slate–in terms of my disease and immunization history. One could even say I’m now more like a one-year old child than a 51-year old man, at least from an immune system standpoint. Given my experiences over the past couple of years, I can think of a lot worse things to be…

Following are all the tests and consults that were shoehorned into the four days, for those of you who enjoy minutiae or just like reading lists. If you’re not of that ilk, maybe you’ll simply want to belt out a few verses of that classic bloodletting round, “39 Vials Of Blood.” C’mon, you know the words…

39 vials of blood, is that all?
39 vials of blood?
It’s just for the trial
We need six more vials…
39 vials of blood, is that all?

The Diagnostic Tests

  • Bone Density Scan (wrist/spine/hip)
  • Chest CT
  • Echocardiogram
  • Pulmonary Function Test
  • MRI (upper thighs, bilateral)
  • Abdominal Ultrasound

The Specialist Consults

  • GI/Liver
  • Dermatology
  • Nutrition
  • Pain, Palliative Care And Symptom Management
  • Rehabilitation Medicine
  • Quality Of Life Assessment
  • Social Worker
  • Dental
  • Occupational Therapy
  • Ophthalmology

Other Stuff

  • Venous Assessment
  • Skin-Punch Biopsies (6mm left arm, 2 stitches; 4mm inside left cheek)
  • Full-Body Photography

The new abnormal; or, “stuck” in Bethesda

Yes, it’s that special time of year again, when our thoughts naturally turn to things like vampires, dripping blood, terrified screams in the darkness, the donning of masks and the reanimation of dead tissue. I’m speaking, of course, about the one-year anniversary of my stem cell transplant, which in the most bizarre of coincidences happens to fall precisely on All Hallows’ Eve. Since it’s been a whole year now, I would like to report to you that all’s well that ends well, as they say, and we move on.

The truth is… a bit more complicated than that.

Approximately half of those who receive human stem call transplants (HSCTs)–and that half includes me–are affected to some degree by what the docs call chronic graft vs. host disease, or cGVHD. Put simply, in any transplant situation, even stem cell/bone marrow transplants, the organ that is transplanted is the “graft” and the recipient of said graft is the “host.”

Ideally, the graft (let’s say a donated kidney) and the host get on more or less famously (given that the recipient is maintained on the proper regimen of anti-rejection drugs, of course), and the new kidney lives happily ever after in the abdominal cavity of the host. Occasionally the graft is rejected, which would be a “host vs. graft” situation, and in that event the kidney may need to be removed and it’s back to square one–or kidney #2.

In the case of HSCTs, the host is not just receiving new and hopefully cancer-free stem cells/bone marrow, but because a good chunk of the immune system (every white blood cell in the body, for starters) is created by the new bone marrow, any incompatibility between the transplanted stem cells and the recipient constitutes a “graft vs. host” as opposed to “host vs. graft” situation.

In other words, using someone near and dear to me as an example–namely, me–I’m not rejecting the transplant so much as the transplant is rejecting me. But since the transplant is me now, we can break it down to the point where we can simply say: I’m rejecting me. Now there’s a Hallmark Halloween special for you…

Most HSCT recipients actually experience acute GVHD in the form of a nasty skin rash within a few weeks to a few months after the transplant, and that is not only expected but represents a positive signal that the transpalnt is “working” because it’s attacking what it perceives to be foreign invaders, even though they are just normal ‘host” cells. Typically this acute reaction subsides fairly quickly and the recipient is free to graduate to more pressing matters, such as fighting with their health insurance company and growing back their hair after the chemo regimens.

In the case of chronic GVHD sufferers, the effects linger and can cause all sorts of damage to everything from eyes to liver if left unchecked. A whopping dose of corticosteroids (typically Prednisone) is the weapon of choice against cGVHD, although steroids carry their own side effects (“moonface,” osteoporosis, nasty mood swings, significant weight gain, etc.) so they are not a viable long-term solution.

Then again, they sure beat suffering the cGHVD issues like severely dry eyes, blurred vision, inflamed mouth and throat, major gastrointestinal problems (the specifics of which I’ll graciously spare you), skin rash/tightening/thickening, muscle weakness, chronic pain and a sudden inability to compose brief, succinct email messages.

All of which finally brings us to the reason for this uplifting Halloween greeting. The National Institutes of Health in Bethesda, MD is home to an ongoing cGVHD clinical trial conducted by my new personal hero, Dr. Steven Pavletic, who is on a mission to help chronic GVHD sufferers by first quantifying the issues we face and then assembling that data so that whatever other treatments may be out there, or have yet to be developed, can be assembled and brought to bear against what he insightfully describes as a “man-made” disease.

Now, how exactly will he gather all this data? Folks like me will travel down to the NIH and for four straight days, we’ll submit to being prodded, poked, stuck, scanned, imaged, and questioned relentlessly until we cry “uncle.” Or until Friday at 3:00, whichever comes first.

In return, I get access to all the test results so I can see precisely how much damage has or has not been done to date, my docs at RWJ get a full report on my condition and therefore don’t need to run the standard one year post-transplant tests they would normally conduct on me because they will all be done for “free” at the trial. To say nothing of the fact that I will be afforded the opportunity to quiz some of the leading physicians in their fields as to which GVHD treatments are out there now, which are on the horizon, and which might be most helpful to me in particular. And I’m helping future transplant patients, who will certainly benefit from the information gleaned from all of us.

To give you an idea of the scope of the trial, I’ll be evaluated by an ophthalmologist, a dentist, an immunologist, a physical therapist, a neurologist, a dermatologist, an oncologist, an osteopath, an occupational therapist, and a cardiologist, all leading physicians in their fields and all extremely conversant with GVHD. And that’s just on Wednesday 😉

OK, those consults are actually spread out over four days, but given that I’ve also got quality of life assessments, meetings with Dr. Pavletic and the other investigators, a consult with a pain management specialist, a pulmonary function test and a 2-hour leukapheresis session (blood goes out, blood goes back in), the schedule is pretty grueling…

The excitement starts Tuesday, Nov. 5th at 7 AM at the NIH’s Clinical Center, which–in spite of the best efforts of our esteemed House of Representatives–is once again open for business, with the poking and prodding finally winding down late Friday afternoon. For those of you who may require personalized technical assistance during this time, rest assured that I will be accompanied by a full complement of computers and iDevices and will respond to your inquiries post haste, given that there will be moments throughout the week when I expect to be, shall we say, indisposed.

So, bring it on, as they say, and let the chips fall where they may. If psychotic slasher Michael Myers of “Halloween” movie fame can survive falling from a balcony, being shot and/or stabbed innumerable times, caught in a gas explosion, buried in a mine shaft, beaten with a lead pipe and electrocuted by Busta Rhymes over the course of the original film and no fewer than eight sequels, I figure I can handle a few biopsies and an MRI or two and still escape in the final reel…


The man of the hour, a.k.a. Steven Z. Pavletic, M.D., M.S.:

The trial of the century, a.k.a. “Factors Determining Outcomes in Patients With Graft-Versus-Host Disease”: