Wednesday, September 09, 2015

Bioethics at work (/s)

The reason Stevie Wonder is blind is that he was a premie, and given too much oxygen. This cause overgrowth of retinal blood vessels, which resulted in blindness. about 400 cases are reported each year (and often the docs are sued when this happens: Something that is never part of the discussion). More HERE.

So today, the NYTimes reports on a study where some premies were given lots of oxygen and some given low levels of oxygen.

And (as we have been aware for years) guess what? The death rate was higher in those given less oxygen.

this is supposed to be a valid study, even though the death rate was higher in the low oxygen group of babies.

So why was the study done at all?

contrary to the NYTimes and the NEJM, the definitive study was done in 1980 (maybe they need to do a wikipedia search before they publish.

Studies on rats made this cause seem more likely, but the link was eventually confirmed by a controversial study undertaken by American pediatricians. The study involved two groups of babies. Some [20] given the usual oxygen concentrations in their incubators, while the other group had "curtailed" oxygen levels. The latter group was shown to have a lower incidence of the disease. As a result, oxygen levels in incubators were lowered and consequently the epidemic was halted. Each case of ROP avoided by withholding oxygen "may have cost some 16 deaths".[21]
Silverman, William A. (November 1980). Retrolental fibroplasia: a modern parable. Grune & Stratton. Retrieved 21 September 2013. Chapter 8: "The Consequences of Oxygen Restriction"

So someone sued, and lost because this was "not proven".

“This decision will mean, from a policy and practical point of view, that this kind of research is going to move on,” said Arthur Caplan, head of the division of medical ethics at NYU Langone Medical Center. He said if the judge had agreed to hear the case, “we’d have research slowing down, everyone waiting to see the outcome of a trial before starting projects.”
As for the New England Journal of Medicine authors, “they are a little enthusiastic,” he said, “but they are mainly right because they are breathing a giant sigh of relief that the legal system didn’t find enough to call the Support study researchers to task.”
ah but here is the point:
the article says it was lost on a technicality.

“As the old axiom goes, correlation does not equal causation,” Judge Bowdre wrote. She said the babies’ extreme prematurity “already put them at a very high risk.” The fact that the babies’ injuries “are consistent with” oxygen levels that could have inflicted them “does not show” that those levels caused them. 

 maybe not, but in these days when even small town GP's have pulse oximetry to monitor hypoxia in their patients, one wonders about the details, i.e. if the low oxygen level in the bloodstream was notice in the nursing notes.

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