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Our unethical health reform violates the principle of equipoise

Randomize evaluations to improve health care delivery

By Amy Finkelstein, Sarah Taubman (MIT)
Science, February 13, 2015

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.

http://www.sciencemag.org/content/347/6223/720.summary

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Health care reform unethical by research standards

Science, June 19, 2015

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

http://www.sciencemag.org/content/348/6241/1325.2.full

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Equipoise and the Ethics of Clinical Research

By Benjamin Freedman, Ph.D.
New England Journal of Medicine, July 16, 1987

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.

http://www.nejm.org/doi/full/10.1056/NEJM198707163170304#t=abstract

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Comment:

By Don McCanne, MD

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 principles. 

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.