My complaint to the National Bioethics Commission, and that sham Commission's indifference
to real abuses by H. Peter Aleff
1 2 3 4 5 6 7 8 9 10 11
The "informed consent" form
hides known dangers from the parents
ROP is an eye disease which began and spread in parallel with the introduction of fluorescent lamps, and which now accounts in this country for more cases of childhood blindness than all other causes combined. You will find a description of this disease and its history in my clinical article "Baby-blinding retinopathy of prematurity and intensive care nursery lighting" which forms Section 1 of my book.
I show there that the fluorescent lamps which the American Academy of Pediatrics specifies for this country's intensive care nurseries concentrate a high percentage of their light energy in precisely the narrow blue-violet wavelength region that has long been known to cause the most retinal damage to laboratory animals and adult humans.
The U.S. Government's Occupational Safety guidelines protect industrial workers from excess exposures to this type of hazardous radiation, but there is no equivalent safeguard for hospital patients, not even for the most vulnerable of them all. In typical intensive care nurseries, the retinae of preemies can be exposed in fifteen minutes or less to the adult danger-limit dose of retinal irradiation, and the babies have none of the adult's defenses against such excess brightness.
Dr. Rand Spencer, one of the LIGHT-ROP study proposal authors, is aware of all these easily verified facts. He has read my article and has refuted none of its contents, as you can see from my correspondence with him on pages 157 to 161 of my book. In addition, he himself lists in his grant application many reasons to expect damage from light to the eyes of preterm infants. In the trial planning grant application, Dr. Spencer and his then co-author, Dr. George E. Sanborn, had explained:
"We believe there are compelling reasons to believe that light may play a role in exacerbating ROP. " (Spencer page 17 middle, emphasis added) and " ... no plausible basis exists for expecting harm from occluding the babies [with goggles to protect their eyes]." (Spencer page 27 middle).
These authors went on to list a number of reasons for their belief in the dangers from light to preemie eyes, including the following excerpts from Spencer pages 10 top, 17 bottom, and 18:
"Susan Trainor, R.N., a member of our planning committee, undertook a study of nursery light levels at the two NICU's in Salt Lake City (...) because it was her clinical impression that the lighting at one of the NICU's in Salt Lake City was considerably brighter than at the other nursery and that there were more infants with more severe ROP in the brighter nursery."
"The study by Ackerman et al. suggests that light reduction may, in fact, protect against the more severe (and blinding) stages of ROP. There were two infants (6%) who developed stage 4 ROP. Both were in the unshielded group. (...)
"It is known that light can damage the retina at levels well below intensities causing thermal burns. This non-thermal damage has been documented in laboratory animals including primates. The degree of damage depends upon the maturity of the retina of the animal exposed with young animals appearing to be more susceptible to damage than adults. The degree of light-induced retinal damage is markedly increased by even small elevations in body temperature. This finding may be of relevance in the neonatal nursery because the premature infants are usually kept either in heated incubators or on open beds with warmers that occasionally result in inadvertent temperature elevations.
(...) higher-than usual oxygen levels have been shown to promote and enhance retinal light damage. This fact is particularly relevant in cases of premature infants with extremely low birth weight (...). [The] higher arterial oxygen level in the incubator may potentiate retinal light damage.
(...) when a developing fetus is taken from the light-absent in utero environment and placed in the modern neonatal intensive care unit which is well lit 24 hours per day, this increased retinal light exposure and resultant increase in oxidative free radicals may pervert the previous (in utero) spindle cell environment and metabolism, ultimately resulting in ROP.
A relative hypopigmentation of the prematurely born infant's eye may, also, be a risk factor contributing to light exacerbation of ROP. (...)
A recent observation has been that it is the youngest (lowest gestational age) neonates in the nursery and therefore those at highest risk to ROP who spend the greatest percentage of their time with their eyelids open. These very low birth weight infants, also, have poor pupillary constriction and thus may be exposed to higher levels of light."
The Manual of Procedures adds on pages 2-9 to 2-22 a more detailed discussion of Retinal Light Toxicity that includes statements such as
"There is little doubt that in the adult, visible radiation can damage the lens, photoreceptors, and retinal pigment epithelium; the effect of early exposure to light on the immature visual system is unknown." [compare this with Dr. Spencer's comment above that the young are more susceptible to the damage.] "Following are some factors which may affect the susceptibility of the immature retina to light-induced damage." (page 2-11)
"Although much is known regarding photochemical tissue damage, much is yet to be understood. However, there is a clear consensus that the mechanism of cell damage is via the intermediary of free radical- oxidative toxicity. (...) The retina has the highest metabolic demands of any tissue in the body, thus the combination of light and oxygen greatly enhances the probability of deleterious reactions within its component cells." (page 2-13)
"In either theory (...) the common denominator is the cytotoxicity of oxygen via free radical production and the lack of mature antioxidant mechanisms to deal with this in the youngest pre-term infants. What is known about retinal light toxicity points to free radical oxidative damage. The most convincing evidence about the pathogenesis of ROP points to free radical oxidative damage. The same free radicals are generated in each process. Although the relative contributions of both increased oxygen and light are unknown, it is plausible that these are additive, and the basis of our primary question. " (pages 2-14/15)
"Phototherapy for hyperbilirubinemia is performed with high intensity, short wavelength light. This is a particularly dangerous combination." (Page 2-16) [Please note that the standard nursery ceiling lights emit the same short wavelength light in intensities of up to one third the phototherapy strength. Phototherapy lamps are known to damage eyes rapidly, and the eyes of the babies under them get patched; industrial safety standards would allow exposures to typically no more than one per cent of an intensity that causes any observable harm, but hospitals take no precautions against as much as 33 per cent of that rapid-damage- causing intensity.]
"Retinal location variations in ROP frequency may relate to enhanced light exposure in the nasal and temporal quadrants." (page 2-16, citing findings that the ROP damage usually begins in the area of the retina that receives the most light6.]
"Premature infants thus not only receive more light, but also biologically control the potential light toxicity less well." (page 2-18 top)
"Most recently, Repka et al. studied a series of 160 infants with birth weights (1000 grams who were examined in NICUs in Baltimore and Boston. The mean illumination of the nursery in Baltimore was 463 lux and of the nursery in Boston was 126 lux. The brighter nursery (Baltimore) also had a higher incidence of any stage of ROP (64%) as compared with the dimmer nursery (41%). These results lend support to the hypothesis that light is a factor in the pathogenesis of ROP." (pages 2-21 and 2-31, dated June 7, 1995.)
The source cited for that nursery comparison was "Unpublished data" by Repka MX, Fulton AB, Petersen RA, Robinson J, Simmons K: "Retinopathy of prematurity and light". A Medline search in May 1997 did not yet list this article as published, raising suspicions of censorship for outcome reports that make one hospital look so clearly worse than another, and that tend to confirm the blinding action of the officially recommended illumination.)
So, even if the LIGHT-ROP authors could pretend to ignore my outsider's warning about the flagrant safety violation which I had documented to Dr. Spencer, they are thus clearly aware that the current fluorescent nursery lighting can by no means be certified safe for the eyes of premature infants.
However, the parental consent forms do not even mention any of the dangers that the study authors themselves had described. The versions for Buffalo and Dallas say only, in a section titled "Background of LIGHT-ROP Study":
"Some of the reasons why light exposure might be important in ROP are: In the womb during pregnancy, the retina is exposed to very little light. Light energy can be damaging to the adult retina. Previous research into the possible relationship between light and ROP has produced confusing results. One study showed a probable effect of bright nursery light on ROP; another study did not find this to be true.
The San Antonio form uses slightly different wording and adds to the above:
The much shorter form from the Santa Rosa Children's Hospital omits this section entirely and limits its entire discussion of the risks and benefits to:
None of these statements convey even remotely what the study authors know about the dangers involved.
That light energy can damage the adult retina is a meaningless platitude since every parent knows not to look directly into the sun even during eclipses, and most are also aware that welders need special dark goggles to protect their eyes from the unbearable brightness of their welding spot.
Similarly, that "light may be able to damage the premature infant's retina" is no news to anyone who has seen the eye patches on babies underneath bilirubin phototherapy lamps. Parents implicitly trust their baby's physicians to know and check the safe dosage of any treatment they prescribe before they administer it, whether that treatment is a drug or the indiscriminate exposure of all babies to a strong fraction of the therapeutical bilirubin irradiation.
However, the consent form omits to inform the trusting parents that no dose of the particularly retina-damaging light from the nursery lamps has ever been shown safe to the eyes of premature infants, or that a mountain of evidence from animals and humans says it is unsafe to them.