A CHEERFUL LITTLE ESSAY TO START YOUR NEW YEAR RIGHT

 

Don't know when, don't know where

But she is smiling, and that's all I care

 

 

Now here is a depressing little essay to start your new year.  It is based on an article in the NYTimes

http://www.nytimes.com/2016/01/03/us/politics/fda-regulator-widowed-by-cancer-helps-speed-drug-approval.html?smprod=nytcore-ipad&smid=nytcore-ipad-share

and was brought to my attention by Dick Ingwall.

From time to time I have spewed greenish-yellow venom at the FDA for what I perceive to be its excessive caution and bureaucratic incompetence in approving new drugs, especially cancer drugs.  I have not been alone, not by a long-shot; there have been many complaints about the plodding pace of the FDA.  As a perhaps extreme example, the Wall Street Journal once headlined an article “FDA to Patients:  Drop Dead”.

Well, it transpires that the guy catching muvh of this flak was one Richard Pazdur, who is chief of the oncology section of the FDA.  Dr. Pazur’s wife recently died, of ovarian cancer.  Not surprisingly, I guess, the pace of FDA investigation has picked up notably since then.  Also not surprisingly, there is a lot of complaint and suspicion directed at this fact.  I have some thoughts.

It appears that the backbone of medical ethics, the Hippocratic Oath, does NOT contain the phrase” First, do no harm”, although that is held to be the gist of the thing.  But there are many kinds of “harm”.  With regard to a patient suffering from ovarian cancer, “harm” can be inflicted by prescribing a drug that makes matters worse, but equally well harm can stem from refusal to use an untested drug that might help.  A sin is a sin, whether it is one of commission or of omission.  (And thus endith the First Lesson – I sound like old Dr. McMartin in the Beaumont Presbyterian Church of the 1940,s)

In many jurisdictions it is permissible for a patient who is terminally ill to take his or her own life.  Why, then, should it not equally be permissible for such a patient to elect to take an experimental drug – after counselling about possible side effects, of course.

AND, it turns out that it IS possible for terminally ill persons to get access to experimental drugs*.  According to the NYTimes article, every year the FDA receives about 1,000 requests for “compassionate use” – and approves 99% of them.  Maybe I should cut them a little slack, eh?  Ah, maybe not. 

So, anyway, it turns out that Mrs. Pazdur did try an experimental drug – and suffered horribly.  Subsequently she stopped chemo and entered Hospice care.  She had been an oncology nurse and knew what she was doing.

Well, wasn’t this fun?  I think I will go and watch the Seattle Seahawks get the stuffing kicked out of them by the Arizona Cardinals. 

 

* I just learned this.  Stupid me.