The Moral Cost of Methodologic Rigor

What sort of sicko would want to give a critically ill baby a useless and painful shot? Only a sadist! Or a scientist!

The history of research ethics is full of stories about scientists causing harm because their moral sensibilities were numbed by their intense desire to do good. Black men have penicillin withheld so that scientists can study the natural history of untreated syphilis. Children with cognitive disabilities are deliberately infected with hepatitis to test preventive treatments. Elderly patients with dementia are exposed to ionizing radiation to see what doses are carcinogenic. Babies are subjected to painful procedures without adequate analgesia because of a once widely-held belief that babies couldn’t feel pain.

A few years ago, some researchers debated the ethics of such sham procedures.

Cyna and colleagues argued that painful and potentially harmful sham interventions that are “neither inert nor innocuous" should never be permitted. Kallmes and colleagues defended such studies. They opined that, in seeking the proper balance between the protection of research participants and scientific rigor, there are circumstances in which “…the use of an invasive procedure strictly as a control intervention in the setting of an RCT….is not only ethical but also essential for patient protection.”

The devil is in the details. To properly judge the appropriate ethical and methodological trade-offs here, we would need to know more. What is the study population? How much do we know about the natural history of the disease? How convincing were the results of the phase II study? Are there other drugs that target this disease in this population of babies? If so, would it be more appropriate to compare “treatment X” to those drugs, rather than to placebo?

The history of neonatology is rife with examples of treatments that were inadequately studied. That history should make us demand methodological rigor and accept that participation in research studies may protect participants from the harms of inadequately studied treatments. But the history of neonatology is also rife with examples of situations in which neonatal pain is ignored and babies allowed to suffer needlessly. That history should predispose us to oppose any possibility of unnecessary untreated pain. In every case, the burden of proof will rest with the researchers to show why the scientific question about efficacy can only be answered by causing pain and suffering with no benefit to participants in the sham placebo arm.

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