and a look behind the hollow facade of bioethics proclamations
Greatly fanfared government watchdogs
never meant to do their job
The LIGHT-ROP consent form lies
As I explain on my pages 37 and 38, the 1953/54 Cooperative Study had only recorded the percentage of oxygen in the breathing mix but not how this translated into retinal blood oxygenation for the baby. When actual measurements of arterial oxygen tensions became possible, these were incorrectly assumed to be an indicator of the retinal oxygenation.
It had been known since 1924 that the retina has the highest rate of oxygen consumption among all the body tissues and can autoregulate the blood flow in response to changes in oxygen concentrations. This autoregulation makes the amounts of oxygen that reach the retina completely independent of the arterial oxygen tension, and trying to extract the former out of the latter is as hopeless as, say, trying to guess a government's revenues from the money supply in the economy, without any knowledge of tax bases and policies or collection rates and such.
Despite this obvious impossibility, another major cooperative trial was launched in 1969 to explore the alleged relationship between blood oxygen levels and ROP risk. The above mentioned Dr. Silverman described the results in his 1980 book on ROP:
Others concurred that the new trial had failed to show any correlation between arterial oxygen concentrations and the development of ROP. A similar oxygen monitoring study in Miami, published in 1987, yielded the same result (my pages 35 and 36).
The uselessness of trying to control the preemies' arterial oxygen is well known among pediatricians. At a 1988 symposium about ROP, Dr. Sally Zierler, an epidemiologist at Brown University, had dissected the lingering unscientific belief in oxygen as the initiator of the disease:
The editor of Pediatrics, the trade journal of the profession, admitted at the same 1988 symposium essentially the same thing:
Yet, in June, 1993, the National Eye Institute awarded $1.2 million as the initial funding for yet another study of how arterial oxygen tensions relate to ROP (my page 37). This three-year, multi-hospital trial is called Supplemental Oxygen for Prethreshold Retinopathy of Prematurity, or STOP-ROP.
In response to the bankruptcy of the dominant pediatric dogma about oxygen withholding, this new study is based on the suggestion that medical management of oxygen further aggravates the development of ROP. This suggestion had first been tested in 1951 on several hundred infants, shortly before oxygen was undeservedly badmouthed and fell in disgrace.
Back then, those researchers had found that ROP seemed to get worse from low oxygen levels, and the retinopathy regressed when the babies were given higher concentrations. The STOP-ROP study tries now to duplicate this finding by slightly raising the arterial concentrations of oxygen, as compared with the standard rationing.
Although this might be considered a step in the right direction, the STOP-ROP increase in arterial oxygen is so small (from the typical 45-85 mm Hg to a partially overlapping 64-109 mm Hg, versus the about 200-275 mm Hg customary before 1954), and it is administered so late (only once ROP begins to develop, several weeks after birth), that the brain damage and asphyxiating from early oxygen withholding are not likely to be lessened a lot, and the effect on ROP will be nil. This new study will thus be just as wasted as its predecessors and achieve no benefit for the babies.
(The STOP-ROP study is scheduled to last through 1997. I have not seen the consent form for it, but you might find it instructive to obtain one and to compare its description to the parents of the risks from oxygen rationing with the above citations from the clinical literature.)
Illustrating additional cracks in the oxygen withholding dogma, a September 1996 Medline search update for more recent articles on oxygen and ROP turned up several abstracts that now also suggest to try increasing the supplemental oxygen as "a promising treatment" for ROP (#40 on enclosed copies of these abstracts) or suspect low oxygen blood levels as a stimulus for causing the disease (#41).
An experiment on kittens (#20) found that the severity of the retinal disturbance increased as the oxygen given decreased, and that very high oxygen concentrations effectively prevented the rogue growth of the retinal vessels that corresponds in humans to ROP. Its authors recommend therefore, like those of #40 above, supplemental oxygen therapy as a treatment of ROP.
Meanwhile, abstracts from nurseries in China and Denmark state that the duration of the first oxygen administration has no effect on the incidence of ROP (#21), and that deviating blood oxygen levels do not appear as a prime factor in inducing ROP (#45).
And to show how far some researchers are groping in the dark and even in the deep, an abstract from the journal Undersea Hyperbaric Medicine (#22) describes attempts to produce experimental ROP in rats by making them breathe pure oxygen at a pressure of five atmospheres -- a pressure which simulates the conditions in all those intensive care nurseries that happen to be located about 150 feet below the ocean surface.
While physicians admit among themselves the carnage from the early oxygen rationing disaster and the present state of total medical ignorance on the relationship between supplemental oxygen and ROP, the consent form for the LIGHT-ROP trial tells the parents a rather different story:
Some medical writers like to cite the dictionary definition that one who pretends to have knowledge which he does not have is a charlatan12. What, then, are doctors who pretend to know what is just the right amount of oxygen for premature babies?
Imagine for a moment the authors of the consent form had been injected with a truth serum that makes them honest with the parents. The corresponding part of the revised consent form would then read something like this:
If the truth serum was strong enough, they might even have ended their admission to the parents with this still factual assessment of the medical profession ascribed to Jonathan Swift:
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