[ExI] Human Testing

[spike]

>... On Behalf Of Stefano Vaj
Subject: [ExI] Human Testing

On 3 March 2012 05:18, spike <spike66 at att.net> wrote:
>> We have constructed a monstrosity of a procedure to get a new medication
approved...

>...Interestingly, this has much to do with the existing taboo about
research programmes and experiments involving humans...So, while the
prohibition have been relaxed with time, the regulatory system is still
based on the idea that it is morally much better to let 1000 people be
killed by the "hand of god" than to risk to harm one with your own.  --
Stefano Vaj
_______________________________________________

Ja, and this latest case will really tear the mask off of that problem.  We
have long known there are maddening ethical dilemmas posed by medical
research.  Imagine that there is a class of molecules which somehow breaks
up beta amyloid clumps, thereby saving Alzheimer's and Parkinson's patients
(as well as a long list of lesser known degenerative maladies) and this
class of molecules are easily synthesized.  In order to determine the
efficacy, you need a control group, a subset of patients who get a placebo.
These die, and ruin their families in the process, all while there is
growing consensus and evidence that the medications given to the others are
effective.  These live, and perhaps leave the medical facility.

For a double blind test to be done correctly, the placebo patients must be
chosen randomly.  There is no way for the researchers to give the real meds
to those who have a ton of money for instance, for that could (and probably
would) skew the results.  They can't pick the smartest patients for real
meds either.  The doctors would not know which patients were being given the
real meds.

So suppose the doctors recommend the trial be halted and all the patients
are given the medications (this is a common outcome.)  They reason that it
would cost less than four cigarettes a day and is relatively mild in side
effects.  Recall that the trial was halted early, so it still is not clear
if the medications are effective.  Then we risk introducing another Aricept,
which is the current commonly prescribed AD medication, which from firsthand
observation of a family member, appears to do not a damn thing, and yet it
too has a list of side effects and risks.  

So now we are in a hell of a position: if ANYTHING works, or seems to, it is
probably better than the go-to drugs we now have, Aricept and Namenda.  So
we are at a high risk of moving to a medication which may not work very
well, but is better than two meds we know don't work very well either.  To
make things worse, Aricept and Namenda apparently do help some patients.
The syndrome we call Alzheimer's is actually a collection of related
disorders.  Untangling all of it is wildly complicated.

In all the articles I am reading, the chemical class to which bexarotene
belongs is creating a stir for a reason I find striking: in these articles
the medics will marvel at the gentleness of the side effects.  They are not
actually claiming these medications work against the disease, but seem to be
say, WOW this doesn't kill our patients!

If so, bexarotene might be a huge leap forward, for it is low cost (if taken
at reagent grade) and its side effects are probably mild in most patients.
Then if reagent grade bexarotene eventually proves to be not effective, we
might be in a situation where the patients who take an alternate medical
treatment are better off than those who take the one approved by the medical
establishment, and almost as well off as those who eschew all medications.

Oy vey, is this a hell of a note or what?  How did we get here?

spike