How much should you know before your baby is entered into a medical study? That complicated and heartbreaking question has been at the center of a controversy about a clinical trial that tested the effects of different oxygen levels on premature infants with extremely low birth weights.
A federal judge in Alabama has rejected the legal claims of parents whose children suffered adverse effects after participating. The court's decision was correct -- but not because the consent form given to parents was adequate for them to understand the risks, which as an ethical matter it probably wasn't.
The judge was right because subtle and complicated problems of medical ethics have no place in a court of law, which would almost certainly oversimplify and get them wrong.
Since the 1950s, doctors have known that the use of oxygen to save the lives of premature infants had the unfortunate side effect of sometimes causing blindness known as retinopathy of prematurity. Over time, the level of oxygen used to help premature infants breathe was reduced, thereby reducing the rate of blindness. The current standard of care calls a range of 85 percent to 95 percent oxygen levels in the infant's blood. But there was no definite consensus on where in that range would be ideal for reducing blindness while preserving infant safety.
The point of the study was to get the right answer by randomly assigning premature infants oxygen levels of somewhere between 85 percent and 95 percent. The consent form, you'd think, would have laid out the hypothesis that too much oxygen would increase the risk of blindness while too little might have other costs to infants' health. But it didn't.
Instead, the consent form included this sentence: "Because all of the treatments proposed in this study are standard of care, there is no predictable increase in risk for your baby." The form was approved by 23 institutional review boards, and the study was then conducted at 22 U.S. hospital sites.
This is a sentence that only a lawyer could love -- or a doctor who wanted parents to participate in the study. Technically, the form was saying that because all the infants would get oxygen in the 85 percent to 95 percent range, which was considered the acceptable standard, the researchers couldn't compare a given patient's predicted results with any other baseline. Formally, this was true: You can't do a comparison without a baseline, and there would be no way of knowing what treatment an infant would get if it wasn't in the survey.
But imagine that you're the parent: Wouldn't you want to know before entering your infant in the study what the predicted effects -- and dangers -- might possibly be? That is, wouldn't you want to know that the experimenters were trying to balance the benefits of lower oxygen (reducing blindness) against its costs (other potential health risks to the infant)?
In 2013, the Office for Human Research Protections in the federal Department of Health and Human Services wrote a letter to the experimenters criticizing the consent form as inadequate. The researchers and other scientists fought back in a New England Journal of Medicine essay, and some other scientists and ethicists sided with the agency.
What made the debate so intense was that the study had an unanticipated, tragic result. Lower oxygen levels did in fact reduce blindness substantially. But they also increased the risk of death to a statistically significant degree. Further data from parallel studies in the U.K., Australia, and New Zealand reproduced these results; two of those studies were shut down early as a result.
To be sure, the results shouldn't be used to say the study was unethical. If the experimenters had known or anticipated they would be increasing infant deaths, they wouldn't have proceeded. But the results did underscore the arguably problematic nature of the consent form.
Then came the class-action lawsuit. Parents of infants who were entered in the study and also had injuries alleged that the study had caused the injuries. They argued that it was statistically "predictable that some infants would experience increased risk of … blindness, while others would experience increased risk of death."
The court rejected the claim that increased risk of harm should count as a malpractice injury under Alabama law. It said, in essence, that the parents couldn't prove their infants were injured by participating in the study, because they were already at risk for blindness or neurodevelopmental difficulty by virtue of being extremely premature. "Correlation does not equal causation," said District Judge Karon O. Bowdre -- and the parents needed to show that participation in the study probably caused their children's injury to proceed.
In a narrow, individual sense, the court's statement was correct: There is no way to show that any individual participant's outcomes were caused by the protocol.
But, of course, the point of a statistical study like the clinical trial is to establish statistical correlation sufficient to prove probable causation.
The study now stands for the scientific proposition that oxygen levels close to 85 percent cause more deaths than oxygen levels closer to 95 percent, which cause more blindness. That's a causal claim. And the infants were part of that study. The court's reasoning is, therefore, another example of why the general public finds lawyers so obtuse.
Yet the result is nevertheless a good one -- because the problem with this study was the informed consent, not the study itself. That's almost always an ethical matter, not a legal one. And courts are bad at medical ethics. The last thing we need is for research scientists to be looking over their shoulders at possible litigation if their study results turn out badly. That would lead to less science, and less knowledge. Which means more, not fewer, infants would end up injured or dead.
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