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Posted on March 27, 2020 at 12:19 AM

Let us stipulate at the outset:
first, that so much—far too much? –is being written on the COVID-19 outbreak,
and wisdom is a precious commodity; second, that although your correspondent is
an MD, he is as bewildered as anyone by the storm of reports, claims, data,
projections, arguments; and third, that whatever public comity may appear to
pertain now, in due time we likely will be at one another’s throats with blame
about who should have been better prepared or done what when, and there will be
plenty of blame to go around.  Our
leaders, national and regional, are especially to blame, but the evidence abounds
that too many of us took this too lightly throughout January and February.

This being a bioethics blog,
however, a few comments about some ethical issues in an outbreak, from a 2018 paper
on the subject.  The paper in question raised
three major topics: ethics of treatment research, triage, and the duty (by doctors
and other health professionals) to provide care.

The last point first: it is well
established that the covenantal duty of doctors in particular is a willingness
to efface self-interest for the interests of the patient.  There is no dispute that this duty is being
followed faithfully by the doctors, nurses, and others who are caring for
people sick from COVID-19.  But a related
duty of society is to do what it can to limit the risk to the caregivers
themselves.  This is clearly pressured by,
for example, the limitation on personal protective equipment (PPE) supplies.  We owe it to the medical community to provide
them with what they need.

Next, triage:  try as we might, and fail as we might (and
always seem to) to prepare in advance for a possible outbreak, surprise never
fails to assert itself, and shortages of things that really matter loom.  At this writing, I have no idea whether New York
City’s capacity to care for the sick is destined to, or is already, hopelessly
overrun “under any scenario,” as Gov. Cuomo said this morning, or
whether we can take any comfort in the assertion this evening by Dr. Birx that
“there are still ICU beds and ventilators” in New York.  In early March, an infamous discussion at the
American Hospital Association projected as many as 1.9 million people needing
ICU care nationwide, and about half of those needing ventilator care, and it is
further widely said that the typical ICU stay, even for someone relatively
young, is 2-3 weeks.  Numbers far fewer
than that would outstrip our national capacity, it
appears
.   Then again, the real
shortage may not be ventilators, but the
doctors to manage them
.

These concerns also arose in
the first Ebola outbreak
a few years ago, and much-discussed principles of
allocating scarce resources apply.  First
and foremost is to try to alleviate the shortage through the best possible
resource management.  Failing that, if
hard choices must be made, then the likelihood of achieving clinical success is
a top criterion.  But that requires clinical
judgment that may be uncertain, requiring a lottery system, or a registry (as
is done for organ transplantation). 
Perhaps most controversial is to make an attempt to prefer treating
people who are judged, if treatment succeeds, to have more life to live or more
potential lifetime contribution to society to offer.  In that case, who decides, and how one
decides, become very dubious judgments to make.

In the moment, there may not be
enough critical care resources to go around, and doctors have to make a hard
choice to treat one person but not another. 
Physicians in Italy are reported to have faced exactly this choice this
month.  Another principle, easy to say
but hard to follow (talk is cheap!), is that triage “should not be a
bedside decision,” that is, the treating doctor should not be forced to
make a choice, but a previously-settled decision process should be
applied.  I do not know whether that was
or is possible in Italy, or in New York, or elsewhere in the U.S. or the world
during this outbreak.

If we indeed are committed to care
for and conserve our most precious care resource, our doctors, then that, in
addition to limits on the number of available beds, might be adduced in favor
of a so-called “universal” or “unilateral” decision that
resuscitation (CPR) of some patients—which will increase the risk of the doctors
and nurses getting infected—simply will not be attempted if their heart stops, regardless
of whether the patient desires the attempt. 
I know of no evidence that this is being done anywhere, but it is the subject
of some speculation in the press.  The
proper process is for a careful end-of-life conversation to happen between
doctor and patient, before being confronted with the need, so that the
patient’s wishes and the doctor’s professional recommendation can be considered.  But if that did not happen for people seriously
ill with COVID-19, it may be too late when the illness strikes.  Those of us “of a certain age” are
wise to consider this question in advance—viral outbreak or no.

Finally, the ethics of experimental
treatment during a disease outbreak are governed by a well-defined regime of
human subject research.  The key
principles follow the Belmont principles reviewed by Mark McQuain on this blog
on March 17, and include that risks to subjects must be limited as much as
possible; that the necessary research risks not be excessive compared to the
potential benefit to the subject at hand or society at large; that informed
consent be properly obtained and documented; and that vulnerable people or
those less advantaged not be denied access to potentially promising treatment nor
be disproportionately placed at risk or have their vulnerabilities taken
advantage of.

In the case of this present outbreak, research ethics also require that experimental treatments be properly studied in adequately designed clinical trials.  Implications, IMO, include that people be randomly assigned to treatment alternatives.   It is true that “off-label” use of drugs that are available for other uses is legal when prescribed by a licensed physician, and such off-label use is not on its face evidence of malpractice.  However, society stands to benefit by collection of data about the COVID-19 disease and outcomes of treatment, and so even off-label use should be done in a clinical trial, not in a “right to try” approach.  Because COVID-19 can be so severe, and the need for treatment is so great, I am inclined to think that random assignment to a placebo is a suspect requirement, I must admit that the need to learn more about the natural course of COVID-19 infection probably requires a placebo group in most, if not every, clinical trial.  There is not enough prior knowledge to rely on comparing a past group with a current, treated group, to conclude whether a new treatment works.  But requiring a placebo further requires that the trial get done fast and carefully, so results are as clear as possible, and made pubic immediately.  We should have no doubt at all that everyone doing the trials wants that.

I note that the public registry of clinical
trials includes several
in the U.S
., including a national, 3000-person study of whether
hydroxychloroquine may prevent disease
in people exposed to others with
COVID-19 disease.

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