retinopathy of prematurity.org
Baby-harming medical research
about baby-blinding retinopathy of prematurity
by H. Peter Aleff, 2005 to 2009
Chapter 4: Medical and governmental cover-up
4.1.. New whitewash study knowingly delayed shading
Despite those nurses’ trial at Yale, the questions about the improbable safety of bright fluorescent light for babies who still belonged into a dark womb did not go away. Skeptical parents and a medical consumer organization kept pointing out the undeniable and well documented risks of this unnatural environmental factor in the print media and on TV.
In response to a series of formal requests and much prodding by parents in that state, the New York State Commissioner of Health, Dr. David Axelrod, appointed a "Technical Advisory Group on the Lighting Environment in Nurseries" to allegedly examine these risks. However, the actions of this Advisory Group showed quickly that its purpose was only to whitewash the current practice.
In its first meeting, the chairman of that Group, Dr. L. Stanley James, contradicted himself on basic facts. When the nursery critics among the participants challenged his doublespeak, he simply reneged on his earlier promise to make the tape recording of the session available to them, and he also excluded them from all further meetings.
After two years of inaction and finally an intervention by a concerned State Senator, that Advisory Group produced in February, 1990, a "Report on the Lighting Environment of Newborn Nurseries" that refuted none of the evidence against the light but misquoted its authors' own clinical references and misrepresented the risks to the babies. This Report was so visibly flawed that it was no more useful in deflecting the charges against nursery lighting than those casually draped light blankets in Yale had been. More convincing evidence was needed.
To "settle the question" with “a standardized examination protocol” that would support their results with the authority of the most rigorous methods in medical science, two pediatric retinal surgeons from Dallas proceeded with their preparations for a large multi-center trial which they called LIGHT-ROP. They had begun to explore the idea informally in a meeting of specialists in August, 1987, but their grant application got funded only after it turned out that the whitewash report from the New York State Technical Advisory Group was to transparent to cover up the evidence against the nursery lighting.
The grant applications and Manual of Procedures for the final version of this LIGHT-ROP trial are available from the U.S. National Eye Institute under the Freedom of Information Act. Because the copyrights to this publicly financed document are in the public domain, you can also find extensive excerpts from that Manual, posted with my annotations, in the series of web pages that begins at LIGHT_ROP_Manual01. These pages show in the authors' own words the several layers of frauds and deceptions in that trial, such as these examples:
· The LIGHT-ROP authors lied to the medical community about the relevance of their study by knowingly delaying the protection of their allegedly protected group until much to late, and then reporting the knowingly false "no difference" conclusion obtained with this subterfuge;
· They also lied to the parents of the babies they wanted to enroll in their study about the dangers from light to eyes of newborns which they themselves had described in their grant applications but about which they did not inform the parents in their deceptive "informed consent" forms;
· Moreover, they intentionally maximized the exposure of the babies to the radiation which they had described as potentially dangerous to their eyes. They even forbade the nursery staff and parents to shade the babies with the usual blankets draped over their isolettes because they wanted to “increase the contrast” between their study groups.
Now to the fraud against science: as in the earlier flawed studies that ignored the speed with which excess light can damage unprotected eyes, the LIGHT-ROP designers decided to again delay the protection far beyond the time when it could have done any good. However, whereas this fatal error in the earlier misleading studies could possibly be explained with the unfortunate ignorance of their authors about the rapidity of light damage to vulnerable baby eyes, the designers of this LIGHT-ROP study have no such excuse.
They knew from several of the references which they themselves cited in their grant applications and in their Manual of Procedures for the trial that the light damage they pretended to study is inflicted typically in a matter of minutes. Yet, they left even their allegedly protected preemies exposed to the full glare of the typical wall-to-wall fluorescent lamps for up to 24 hours before they patched their eyes.
The goal of that new rigged trial was therefore clearly to exonerate the current nursery lighting practice by showing no significant blinding difference between the unprotected and only allegedly protected groups.
Dr. Rand Spencer, the author of the initial planning grant application, described the need for such a trial in his response of May 23, 1990, to the grant examiners’ question why patches or goggles would be preferable to other methods of light reduction. He gave eight reasons, for instance that
but his longest and last argument was:
The lead author of the final grant application, Dr. James D. Reynolds, expressed even more directly the priority of ending the charges against the current nursery lighting practices:
Similarly, he said in the Manual of Procedures, on page 2-9, in explaining the reasons for the study:
In other words, the predictably rigged “worthwhile” outcome with no ROP difference between the groups will deflect “undue” attention from the role of the Academy-specified nursery lighting in the ongoing blinding epidemic.
By asserting the innocence of those eye-damaging lamps with the ex cathedra authority of a multi-hospital American clinical study, that outcome will let these lamps continue to sear the retinae of many preemies and so to maintain the steady stream of patients from which many pediatric retinal surgeons will continue to derive steady incomes.
That “worthwhile outcome” of falsely rejecting the real reason for the blinding will also allow intensive care nurseries to continue their profitable billing for expensive but often lethal or brain damaging oxygen management services to the preemies. And all will thus be for the best in this best of all possible worlds.
4.1.2 The LIGHT-ROP authors’ own sources contradict their delayed timing
The LIGHT-ROP authors described the light damage to be checked as photochemical, which means it is a function of both intensity and time, just like the photochemical reaction in photographic film where the latent image is controlled through both lens opening and shutter speed.
Most radiation damage, including photochemical tissue damage such as sunburn or retinal lesions, accrues from relatively short exposures and is at first similarly latent to then become visible only some time after the exposure. Typical exposure times that produce photochemical retina lesions in animal experiments range from 10 to 10,000 seconds, and latency times until the development or observation of the lesion are reported from a few hours to several weeks after the exposure.
The authors of this trial knew therefore that the time right after birth is the most critical period for light damage to the babies’ eyes, and that protecting them during this time of highest vulnerability is crucial.
The LIGHT-ROP authors were well aware of this concern. However, they delayed again the granting of the goggles for up to 24 hours. Several of the sources which they themselves cited in their Manual of Procedures for the LIGHT-ROP study demonstrate that they knew this delay is much too long to prevent the photochemical light damage to the retinae of these babies which they pretended to study.
Here are the details:
At the beginning of their chapter on “Retinal Light Toxicity” on page 2-9 of that Manual, the authors distinguish thermal damage caused by very intense light sources from photochemical damage which can be produced by much lower light levels. They say that thermal damage has been known for hundreds of years, meaning the retinal burns one suffers from looking at the sun for just a few seconds. Then they continue:
(Manual of Procedures for LIGHT-ROP, page 2-9, near bottom, and page 2-10 top).
Half a page later, the LIGHT-ROP authors cite a study in which mice suffered retinal damage “which occurs in albino mice in less than 12 hours at intensities of 250 to 450 lux” whereas similar disruption in pigmented animals “takes 14 hours at 3500-4500 lux”. One lux is 0.0929 foot-candles, so the light levels that harm albino mice in such short times amount to only about 23 to 42 ftc.
For comparison, those eye-damaging light levels are lower than the routine light levels in many intensive care nurseries. The “Guidelines for Perinatal Care”, issued jointly in 1988 by the American Academy of Pediatrics and the American College of Obstetricians and Gynecologists, recommend 60 ftc, and various clinical papers report even higher levels from actual measurements in intensive care nurseries, as cited above.
The Light-ROP authors misquote those same Guidelines which they cite as their reference 78 but seem not to have read. They say in their Manual, on page 2-15 near bottom:
They also knew, or were supposed to know from the most basic due diligence required before proposing their study, that the preemies' lack of eye pigmentation is similar to that of the albino mice who were damaged by only 23 to 42 ftc. And even if they had ignored this absence of pigment in the eyes of the preemies whom they said they wanted to study, they should have computed that the intensity of about 325 to 418 ftc that damaged the pigmented mice in 14 hours is comparable to the irradiation from the bilirubin lamps common in intensive care nurseries. These typically irradiate at the baby level from about 300 to about 600 ftc, and these painfully bright lamps are often allowed to shine on the unprotected isolette-neighbors of the eye-patched preemie so treated.
Moreover, the retinae of all the mice in these tests were already developed and therefore more stable whereas the human babies’ retinal “target tissue” gets exposed during its most active stage of development which makes it even more vulnerable. These facts alone should have alerted the study authors to the danger of exposure times much shorter than their "up to 24 hours", but these authors willfully ignored them as well as all their other inconvenient data about the alleged subject of their study.
The LIGHT-ROP Manual lists about a dozen references for its discussion of photochemical eye damage. I had in my files, or was able to obtain from the New York Academy of Medicine Library, only four of the papers cited, but all of these reported or discussed light damage from similar and even shorter exposure times. Here are highlights from these four papers to which the LIGHT-ROP authors refer repeatedly:
Page 1187 right of that source describes severe retinal damage caused to rats by exposures of 4 hours. That damage is getting worse with increasing latency times until examination after one, two, and four days. See also page 1188 for severe rhodopsin bleaching in vivo from exposures of only 5 minutes to green and UV-A light. [Rhodopsin bleaching is the usually reversible precursor to irreversible retinal damage.]
The abstract reports retinal damage to adult monkeys from single 12 hour exposures to irradiations of 195 to 361 mW/cm2 at the retina. That is only 3½ to less than 7 times the 53.4 mW/cm2 computed above for the retinal irradiance of a much more vulnerable preemie under the recommended 60 ftc nursery lighting.
The latency time during which this “threshold damage” developed was only 15 hours (page 429 left), suggesting that lower intensities would probably have been found to cause similar damage if the examinations had been delayed.
Indeed, on page 432 right of that article, exposure to a threshold retinal irradiance of only 10 mW/cm2 for 4 hours from a broad spectrum xenon arc source produced retinal damage when examined 60 days after that exposure. (ROP usually becomes detectable several weeks after the birth of the preemie, depending on severity and gestational age.)
See also page 432 bottom left for damage in many retinal layers of newborn monkeys, caused by 12 to 24 hours under a 400 ftc bilirubin lamp, and for visible lesions produced by a 1000 second exposure to 441 nanometer blue-violet light, a wavelength very similar to the intense 435.8 nm radiation spike in the spectrum of the fluorescent nursery lamps. At the bottom of the right column on that same page, see
Compare further page 433 left, bottom:
Here the authors show their knowledge that the preemies' eyes do not have much pigment protection and are therefore more comparable to the eyes of the above albino mice than to the pigmented ones .
Table 2 on page 1166 right, top, summarizes that retinal damage in rats was produced by 50 to 200 ftc applied for 8 to 48 hours. See also the middle of the same column where abnormally light-vulnerable mutant rats suffer widespread retinal damage from exposures with effective durations of less than one hour.
Here again, we must remember that the eyes of human preemies are also abnormally light-vulnerable during the time when their retinal cells are still developing and migrating. For all anyone knows, prematurely born humans could be even more vulnerable than those mutant rats, and no one can responsibly assume that preemies might be somehow more resistant.
Already the lead sentence of that article states:
That is two to 17 minutes. All the light damage experiments reported in this paper were performed with a uniform exposure time of 100 seconds to blue-violet light in the 435 to 445 nanometer wavelength range (page 168 right, bottom). Let me again point out that the salient energy spike in the spectrum of the fluorescent nursery lamps is at 435.8 nm.
It is therefore hard to believe that the LIGHT-ROP authors could have missed all these mentions in their own supporting references of the short time frames in which photochemical light damage is typically produced. They said themselves that duration is one of the main factors on which photochemical retina damage is dependent, so one should expect that they did their homework and checked in their sources the durations which produced the reported damages.
Although some of the experimental conditions cited here may have been different (and in some cases even less severe!) than those which a preemie encounters in the intensive care nursery, the evidence from this limited sample of studies is as clear as from the rest of that field: photochemical damage to the retina is inflicted in exposures that are measured in minutes to at most very few hours, and that are in practically all cases much shorter than 24 hours.
Long-term photochemical light damage experiments that include exposures longer than such a few hours are much less frequently described, whether in these papers or in the substantial heap of similar articles that I examined. The main focus of the voluminous literature about photochemical light damage research is on the short exposures that cause most of the damage.
That literature calls retinal light damage from exposures of up to 10 seconds thermal injury and defines photochemical injury as damage from any exposure longer than those 10 seconds. The distinction is an arbitrary convention and does not correspond to a sharp dividing line between thermal and photochemical damage; the transition is rather gradual in a continuum where one or the other of these damage types becomes more preponderant.
Since photochemical effects are cumulative and add up over time, just as in photographic exposures, light intensities too weak to burn the retina in those first 10 seconds can damage it photochemically in just slightly longer periods. There is thus no such thing as a putatively light-safe intermediate zone between the 10 seconds where thermal damage ends and the 24 hours before which the LIGHT-ROP researchers allege to expect no photochemical damage.
Why else would the nurses in most hospitals have standing instructions, in case a preemie under bilirubin lamps pulls off the eye patches mandated as protection against that bright light, to replace those patches as quickly as possible?
The fluorescent lamps in the bilirubin phototherapy unit risk to injure the babies' eyes in minutes (or possibly even in seconds, for all anyone knows) with their irradiation of 300 to 600 ftc. Yet, the LIGHT-ROP authors pretend that the 60 to 100 ftc and sometimes even brighter lighting from the fluorescent lamps in the ceiling fixtures will not damage the vulnerable preemie eyes in steadily accumulating exposures of up to 24 hours.
Incompetence in the LIGHT-ROP trial set-up:
A defender of the LIGHT-ROP authors might try to argue that their flagrant and fatal flaw in the timing is not fraud but mere incompetence, and s/he could cite as support for that excuse their doubly bungled set-up for recording the light level data from the trial:
To begin with, they programmed their monitoring data-loggers to make measurements every 8 seconds but to store only averages of every 75 measurements (Item 5.9.2. on MOP page 5-7). This deletes all peak values, such as, for instance, a stray sunbeam temporarily reflected from the ubiquitous glass and chrome in the nursery hitting the eyes of the baby.
A direct exposure like that could seriously damage an adult retina in less than 8 seconds. When it is optically concentrated, it can permanently blind an adult in a split-second. See, for instance, the repeated and insistent warnings in the issues of Astronomy Magazine preparing its readers for the upcoming solar eclipse on February 26, 1998, such as:
The small diameter and short focal length of the preemie eye concentrate the light that shines through its proportionally much larger aperture onto a much smaller patch of retina than in the larger adult eye where the light gets distributed over a larger area of much more resistant retinal tissue.
Any such exposure to that stray sunbeam would therefore wreak its retinal havoc much faster in the optically concentrating and biologically more vulnerable eyes of a preemie who can moreover not turn her head away as any adult almost automatically would.
Yet, the ten-minute average in the study records would merely show a faint blip: if the monitor catches, say, a 1000 foot-candle sunbeam reflection during one of those measurements, this one value added to the 74 more typical 60 ftc would change the average only to 72.5 ftc, hardly a meaningful difference.
And if someone happens to stand between the monitor and the nearest lamp for only four of those ten averaged minutes and to so reduce the light intensity on its sensor by, say, half, this shading will cancel out every trace of that potentially damaging sunbeam and bring the average back down to 60.5 ftc.
Darker moments during the varying light exposure can certainly not be blamed for any of the correlation between light exposure and harm the study is alleged to test, so the measurements to be preserved would need to include the peaks as the most important data. Without these peaks, the LIGHT-ROP measurements are useless and potentially misleading, and it does not take an Einstein to figure this out.
Secondly, the LIGHT-ROP authors arranged for the visible display of the light monitors to show only arbitrary numbers (Item 188.8.131.52. on MOP page 5-8) so that no one could see at a glance whether the values measured were in the right range, or whether the gadget had gone haywire, as fancy instruments often do. Even the much less complex electronic fever thermometers are known to fail occasionally when they start showing patient temperatures far beyond any compatible with life as we know it.
People familiar with computers have warned again and again against the danger of errors in computerized data when these are stored without confirmation and verification, and any engineering apprentice or modern factory foreman could have told the trial authors that such unseen recording without checkable and frequently checked feedback is an infallible guarantee of wrong data.
Yet, apparently the LIGHT-ROP researchers verified none of their data-loggers' measurements until their two-year study was almost over. Shortly before its initially projected end, they discovered that their fancy on-line light monitoring system had "a significant flaw, rendering that data false and unfortunately useless" (See Dr. Reynolds' Progress Report of February 1, 1997).
However, even if said devil's advocate for the LIGHT-ROP authors could allege that their demonstrated lack of common sense in their data recording set-up showed they were also too incompetent to understand the literature they are citing, s/he could still not argue that they overlooked this matter of initial exposure time by ignorance or accident.
I had sent to Dr. Rand Spencer, one of the original LIGHT-ROP proposal's co-authors, my clinical article "Baby-blinding retinopathy of prematurity and intensive care nursery lighting" that documents in detail how typical nursery lighting exposes the vulnerable eyes of the preemies in 15 minutes or less to the dose of retinal irradiance which the Occupational Safety Guidelines warn against as the danger limit for healthy adult workers.
Dr. Spencer said in his reply, without refuting or even addressing any of the evidence about the speed with which light damage occurs:
In other words, he knew that the delay in protecting the allegedly protected group was much longer than the time needed for the damage, but he willfully chose to ignore this obvious flaw in his study design.
Similarly, Mr. Bill Sardi at Eye Communications Inc. in Upland, California, had alerted Dr. Spencer to the same danger, and Dr. Spencer reassured him on October 23, 1989:
The LIGHT-ROP authors were thus aware of these warnings and have not refuted them or shown that they can be safely ignored. Yet, they and their sponsors avoid all discussion of the short exposure periods that they know to have produced retinal damage in the different experiments they cite. They also ignore the mountain of similar experiments on which the industrial safety data are based. Instead, they knowingly delay protecting the babies for up to 24 hours, as in most of the previous studies. Why?
The official explanations that the LIGHT-ROP authors and their sponsors give for the reason behind this crucial delay vary according to the intended audience. For the general readers of PARADE magazine, Dr. Karl Kupfer, the Director of the National Eye Institute, conjured up a dramatic but exceptional situation and says, as quoted by Bernard Gavzer in the above cited June 1 issue:
This misleading scenario of breathless haste and instant plop-out birth is as wrong as Dr. Kupfer's patronizing presumption to know what a mother is able to understand.
Such emergency births upon arrival at the hospital may happen occasionally, but if you look at the obstetric literature or ask parents of preemies, you find the much more common case is reflected in Mrs. Margie Watson's comment in that same article: that she was in the hospital many hours before giving birth to her preemie daughter and would have had plenty of time to consider the proposal of a study.
This publicly alleged excuse for the delay in protecting the babies would appear so transparently false to the intended readers of the LIGHT-ROP Manual of Procedures -- professionals who work in hospitals -- that the Manual does not even mention it. These more experienced readers are given a less easily verified reason for not requesting the parental consent during labor:
However, this pretext does not bear scrutiny either. In the many trials for testing lung surfactant in preemies unable to breathe by themselves, the investigators typically had to administer this potentially lung-enabling medication almost immediately after the baby's birth, so the parents must routinely have given their consent to these experiments during labor.
Furthermore, to ignore such a crucial parameter of the investigation for reasons of cost and logistics is acting like a maker of fake sailing charts who shows everywhere safe depths and knowingly leaves out the sunken reefs and rocks because showing these hazards -- the ostensible purpose of the chart -- would take too much drafting time.
The initial $497,078 budget of this explicitly cost-conscious LIGHT-ROP study, before it was increased to more than a million dollars, granted the researchers $5,649 for each of the babies to be provided with up to six $9.60/pair goggles, leaving $5,591 per goggled baby for her and her controls' couple of extra eye examinations each and for the overhead expense of recording their results36.
The money earmarked for copying paper supplies would have bought about ten times the weight of each baby in reams of paper to note whether s/he had ROP or not, so the trial administrators could certainly have spared a few extra consent forms for the mothers in labor across the hall, or even across town.
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