[ExI] Human Experimenting

[Stefano Vaj]

I think that the following remarks may have something to do with the
subject recently raised on experiments performed with their consent on
inmates facing execution (or perhaps even just long jail sentences),
obviously with same trade-off as to their sentences.

<<The last half of the 20th Century was a time of explosive growth in
growth in high technology medicine. Effective chemotherapy for many
microbial diseases, the advent of sophisticated vaccination, the
development and application of the corticosteroids, and the
development of extracorporeal and cardiovascular prosthetic medicine
(cardiopulmonary bypass, hemodialysis, synthetic arterial vascular
grafts and cardiac valves) are but a few examples of what can only be
described as stunning progress in medicine derived in large measure
from translation research.

The closing decades of the last century brought confident predictions
from both academic and clinical researchers (scientists and physicians
alike) that the opening decade of this century would see, if not
definitive cure or control, then certainly the first truly effective
therapeutic drugs for cancer, ischemia-reperfusion injury (i.e. heart
attack, stroke and cardiac arrest), multisystem organ failure and
dysfunction (MSOF/D), immunomodulation (control of rejection and much
improved management of autoimmune diseases), oxygen therapeutics and
more radically, the perfection of long term organ preservation,
widespread use of the total artificial heart (TAH) and the clinical
application of the first drugs to slow or moderate biological aging.

However, none of these anticipated gains has materialized, and
countless drug trials in humans based on highly successful animal
models of MSOF/D, stroke, heart attack, cancer, and immunomodulation
have failed. Indeed it may be reasonably argued that the pace of
therapeutic advance has slowed. By contrast, the growth of technology
and capability in some areas of diagnostic medicine, primarily
imaging, has maintained its exponential rate of growth and, while much
slower than growth in other areas of technological endeavor, such as
communications and consumer electronics, progress has been impressive.

Why has translational research at the cutting edge of medicine (and in
particular in critical care medicine) stalled, or often resulted in
clinical trials that had to be halted due to increased morbidity and
mortality in the treated patients? The answers to these questions are
complex and multifactorial, and deserve careful review.

Renewed success in the application of translational research in humans
will require a return to the understanding and acceptance of the
inescapable fact that perfection of complex biomedical technologies
cannot be modeled solely in the animal or computer research
laboratory. The corollary of this understanding must be the acceptance
of the unpleasant reality that perfection of novel, let alone
revolutionary medical technologies, will require a huge cost in human
suffering and sacrifice. The aborted journey of the TAH to widespread
clinical application due to the unwillingness on the part of the
public, and the now extant bioethical infrastructure in medicine, to
accept the years of suffering accompanied by modest, incremental
advances towards perfection of this technology, is a good example of
what might rightly be described as a societal ‘failure of nerve’ in
the face of great benefit at great cost. It may be rightly said, to
quote the political revolutionary Delores Ibarruri, that we must once
again come to understand that, “It is better to die on our feet than
to live on our knees!”>>

As unpleasant as the subject may be, the inmates issue is of course
part of the much broader subject of experiments on human subjects,
which I submit is excessively restricted in contemporary times, up to
a level the justification of which, be it from a utilitarian, a
promethean or most other ethical POVs, is not entirely clear.

In particular, relatively high-risk experimenting calls in question a
number of other scenarios, such as:
- self-experimentation by the researcher;
- terminally sick patients;
- embryos, fetuses and anencefalic newborns;
- "volunteers" by way of contractual acceptance of the risk involved.

Stefano Vaj