Thursday, June 18, 2015

qotd: Our unethical health reform violates the principle of equipoise

February 13, 2015
Policy Forum
Randomize evaluations to improve health care delivery
By Amy Finkelstein, Sarah Taubman (MIT)

The medical profession has long recognized the importance of randomized
evaluations; such designs are commonly used to evaluate the safety and
efficacy of medical innovations such as drugs and devices.
Unfortunately, innovations in how health care is delivered (e.g., health
insurance structures, interventions to encourage the use of appropriate
care, and care coordination approaches) are rarely evaluated using
randomization. We consider barriers to conducting randomized trials in
this setting and suggest ways for overcoming them. Randomized
evaluations of fundamental issues in health care policy and delivery
should be — and can be — closer to the norm than the exception.


June 19, 2015
Health care reform unethical by research standards

A. Finkelstein and S. Taubman report on the underuse of randomized
controlled trials for U.S. health care reform ("Randomize evaluations to
improve health care delivery" Policy Forum, 13 February). This reliance
on suboptimal research compromises information needed for policy.
However, a second problem about health reform decision-making is more
serious, constituting a major ethical breach.

The principles of research with humans require that deviations from the
standard of care are allowable only if there is real uncertainty
regarding which intervention is better. This is called the "principle of
equipoise"; only when we don't know which strategy yields the best
results is it acceptable to compare them (1).

Yet for health care reform writ large — i.e., the basic payment system —
there is no equipoise. Research from dozens of developed countries
demonstrates convincingly that single-payer financing reduces costs,
assures access, and improves outcomes.

To ignore this compelling evidence risks lives in the United States as
we experiment with partial fixes to the multi-payer system. This
experimentation would be rejected by any responsible university
institutional review board as violating the principle of equipoise and
causing unacceptable patient harm.

James G. Kahn (UCSF)
Paul Hofmann (Moraga CA)

1. Freedman B. Equipoise and the Ethics of Clinical Research. N Engl J
Med 1987; 317:141-145


New England Journal of Medicine
July 16, 1987
Equipoise and the Ethics of Clinical Research
By Benjamin Freedman, Ph.D.

The ethics of clinical research requires equipoise — a state of genuine
uncertainty on the part of the clinical investigator regarding the
comparative therapeutic merits of each arm in a trial. Should the
investigator discover that one treatment is of superior therapeutic
merit, he or she is ethically obliged to offer that treatment. The
current understanding of this requirement, which entails that the
investigator have no "treatment preference" throughout the course of the
trial, presents nearly insuperable obstacles to the ethical commencement
or completion of a controlled trial and may also contribute to the
termination of trials because of the failure to enroll enough patients.

I suggest an alternative concept of equipoise, which would be based on
present or imminent controversy in the clinical community over the
preferred treatment. According to this concept of "clinical equipoise,"
the requirement is satisfied if there is genuine uncertainty within the
expert medical community — not necessarily on the part of the individual
investigator — about the preferred treatment.


Comment by Don McCanne

Here's a shocker. Enactment and implementation of the Affordable Care
Act has been and continues to be unethical, under the "principle of
equipoise." How could that be?

Amy Finkelstein and Sarah Taubman, of MIT, call for an increased use of
"randomized evaluations of fundamental issues in health care policy,"
likening policy research to medical research. On the surface this seems
quite reasonable, but James Kahn and Paul Hofmann reveal the potential
dire implications of such a proposal when policies are studied that, at
best, would fall short of already well established beneficial policy

Medical research requires the adherence to the principle of equipoise -
the principle that it is unethical to expose a patient to an
experimental treatment when there exists a better treatment that would
always be recommended regardless of the outcome of the study. Only when
there is agreement that the more effective and safer treatment is not
known is it ethical to proceed with a randomized trial.

How would this apply to health policy research? In randomized trials
proposed health policies could be compared with existing or other
proposed health policies to determine which policies produce more
favorable outcomes. This would require that the existing comprehension
of the policies would be clearly inadequate to reliably predict the
outcomes. Keep in mind that a health system's policies can impact
individual health as much or even more than the actual health care
received. If the outcomes are predictable, it would be unethical to
proceed with the study.

The problem with the proposal by Finkelstein and Taubman is that health
policy science is quite advanced, and we have a rich body of knowledge
of the potential impacts of various health policies. These researchers
suggest that randomized evaluations should be closer to the norm when,
in fact, it would be quite rare that two or more policy options would be
so poorly understood that it would require a randomized trial to
determine which would produce better outcomes.

To understand the enormous impact of this, let's compare the most basic
policies perpetuated and enacted by the Affordable Care Act with
fundamental policies inherent in a well designed single payer system -
policies that are well understood through our experiences and the
experiences of many other nations.

The Affordable Care Act

* Tens of millions will be left uninsured

* Tens of millions will be underinsured

* Financial barriers to care that result from being uninsured or
underinsured clearly impair access to beneficial health care services
and thus often result in poor health outcomes and even death

Single Payer National Health Program

* Everyone would be insured

* Underinsurance is eliminated by removing financial barriers,
especially high deductibles and coinsurance

* Removal of financial barriers improves access to health care with a
consequent improvement in health outcomes and with a lower mortality rate

Further, our current system wastes hundreds of billions of dollars on
administrative excesses - much of which could be recovered under a
single-payer system and be redirected into health care delivery.

We cannot do a randomized trial comparing single payer with the
Affordable Care Act since a single payer system cannot exist commingled
with a fragmented, multi-payer system, but we would not want to do that
study anyway since we already understand the policy science behind these
systems. Such a study would clearly violate the principle of equipoise.

To continue with our current grand national experiment in health care
reform is clearly unethical because of the financial hardships, physical
suffering and premature deaths that are perpetuated and would be
prevented if we switched to a single payer national health program.

It would be unethical to repeal the Affordable Care Act and do nothing
else since some provisions of the Act are beneficial. But since we can
enact and implement a single payer national health program, we are
engaging in unethical behavior by failing to do so.

Our national policymakers need to understand how profoundly unethical
their behavior is by their continued violation of the principle of
equipoise. People are suffering and dying as a result.

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