20 January 2007
Saturday, 11:35 PM
High-Level Journal Summary: Am I medically considered to be "terminally ill?" Based on my particular diagnosis and treatments to date for brain cancer, a considered response from my neuro-oncologist at NIH, Dr. Howard A. Fine.
I posed this very specific question in response to a Court of Appeals holding on 5/2/06 that "terminally ill, mentally competent adult patients had a due process right to informed access to potentially life-saving investigational new drugs that had been determined to be sufficiently safe for expanded human trials, where there were no alternative government-approved treatment options."
Countdowns:
1.) Day 27 of 28 in my 16th 5/23 Temodar chemotherapy cycle.
2.) Bi-weekly hematology report on 1/21/07 to see how my blood levels are doing.
2007 Seizure Activity:
1.) Last Simple Partial Seizure, or SPS, was 14 days ago.
2.) In 2007, I have had 1 SPS so far.
Actual Journal: In the extended conversation with Dr. Howard A. Fine on 1/19/07, I asked a question in anticipation of the 2/27/07 FDLI Colloquium on Extended Access to Unapproved Drugs. What was this question? Whether or not I am considered to be terminally ill.
Abigail Alliance background, once again
In my 1/14/07 online journal entry, the background of the Abigail Alliance case was provided. Briefly, legal results from the 5/2/06 decision read as follows:
Public interest group brought action seeking to enjoin the Food and Drug Administration (FDA) from continuing to enforce a policy barring sale of potentially life-saving investigational new drugs to certain mentally competent, terminally ill adult patients. The United States District Court for the District of Columbia, Ricardo M. Urbina, J., dismissed. Group appealed.
The Court of Appeals, Rogers, Circuit Judge, held that terminally ill, mentally competent adult patients had a due process right to informed access to potentially life-saving investigational new drugs that had been determined to be sufficiently safe for expanded human trials, where there were no alternative government-approved treatment options. Reversed and remanded.
Am I "terminally ill?"
As I read the above information, there is one phrase that caught my attention -- "terminally ill." That is what grabbed my attention when I first learned about this upcoming colloquium. Per my 12/16/06 online journal entry, I wrote the following:
...the last issue listed is, "In the end, are patients better or worse off as a result of this decision?" I have no idea if they would consider me to be "terminally ill" because I have brain cancer (a dark and interesting question), but I certainly have an opinion on the impact of taking off-label drugs to stabilize my brain cancer, prevent it from becoming fast-growing brain cancer, and ultimately lengthening my years of life.
A conclusive answer
Instead of being inconclusive about whether or not I am medically considered to be terminally ill, I went straight to my neuro-oncologist, Dr. Howard A. Fine, and asked this question. I asked him to answer me directly. I told him that I do not need a pep talk...I do not need motivation to fight...my feelings were not going to be hurt. I have tons of motivation in life, and this medical classification would not change my personal perspective.
With all this, here are some paraphrased notes from the conversation that followed:
1.) My particular form of illness should first be qualified. I have brain cancer. Specifically, I have a grade II astrocytoma in the subinsular and basal ganglia region of the left frontal and left temporal lobe. It has been partially resected (approximately 50%), and I have had 1 year of Temodar chemo with about 1 cm of shrinkage of the visible brain tumor mass.
2.) The above brain cancer diagnosis is an illness that could kill me.
3.) However, my particular illness is not something that necessarily will take my life.
4.) The issue of having a "terminal illness" can be seen in another way. For Dr. Fine and his medical team at NIH, it is not about being "terminal." Rather, it is more about managing the quality of life for each patient.
Digesting this information
For the purposes of the FDLI Colloquium, I would generically fall into the category of being a patient with a terminal illness. (Based on my conversation with Dr. Fine, I can now say that with assertion.) The thing that will be a bit unique, though, is that I have the relative luxury of more time as compared to some other patients.
Do I have the pressure of making a medical decision within the next few weeks about taking a drug that is not yet FDA approved and for which I am not clinically qualified to take? No. That is not my circumstance at this point. However, nobody can say whether or not this will be my circumstance in the future. Of course, I hope like hell that this is not my circumstance, but because it is not an immediate situation for me, I can perhaps speak a bit more dispassionately about this issue.
I sum it up this way:
- I qualify as a terminally ill patient under the Abigail Alliance Decision.
- This legal decision does not immediately impact me.
- This legal decision may impact me in the future.
- I am speaking up now with the perspective that legal decisions today could have impact upon me in future treatments for my brain cancer.
Hopefully, this will take conversations from a legal perspective to a more human perspective.
Final thoughts
At the end of this part of the conversation, I said to Dr. Fine that I understand I am a "data point" right now. After all, there is not much information about patients with slow-growing forms of brain cancer who are taking Temodar chemotherapy for extended periods of time. As such, I am a data point.
That's when Dr. Fine turned, looked me right in the eyes, smiled, and said, "You're a person."
