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  Rigged studies in preemie treatment


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Frauds, cover- ups, and other ethics violations in medical studies of preemies 
by H. Peter Aleff

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My letter to Dr. Feinstein, continued from page 5
Baby-harming fraud
in the current LIGHT-ROP experiment

Section 3 of my book shows you some of my attempts to convince the physicians involved of the easily verified light overdose on the retinae of the preemies, and you can observe there in vivo the "mental stenosis" (as discussed in your pages 52 to 55) and the blatant dishonesty of the medical respondents who either refuse to answer or flatly deny the facts without being able to refute them.

You will find in that Section also my correspondence with various medical authorities about the ethics breaches and clumsy fraud in the most recent one of the flawed light-evaluation studies, the National Eye Institute's current LIGHT- ROP experiment. The enrollment for this experiment continued into 1997, and the follow-up evaluation for it is scheduled to be concluded this month.

The authors of this trial are fully aware 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 (see my pages 220 to 222).  They even criticized one of the prior studies for not addressing this concern.

However, they delay again the granting of the goggles for up to 24 hours, knowing that this trick will produce again an exoneration of the current lighting.  For a synopsis of the several layers of deception in the design and execution of this trial, see pages 215 to 247 of my complaint dated March 24, 1997, about this sham experiment to the National Bioethics Advisory Commission.

As an update to that complaint, please see next among the attachments some extracts from the Manual of Procedures for that trial and from the studies cited in them. These document with the LIGHT-ROP study authors' own sources that they know their delay of up to 24 hours before protecting the preemies from light is much too long to prevent the allegedly to- be- studied photochemical light damage to the retinae of these babies.

Here are the highlights: At the beginning of their chapter on "Retinal Light Toxicity" on page 2-9, 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:

  • "It is photochemical light damage that is of interest to this study. This is dependent on wavelength, intensity, and duration of stimulus and also varies with the biology of the target tissue. [all emphases added]

  • There are two classes of photochemical damage to the retina. Type 1 arises from prolonged exposure to low irradiance levels of mid-visible wavelength light. Type 2 is produced by shorter wavelength light, ultraviolet and blue light, with higher irradiances and shorter durations." (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 about 23 to 42 ftc.

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 (my pages 6 to 8).

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 of Procedures, page 2-15 near bottom:

"... the large majority of infants receive much greater illumination than the recommended 100 foot candles."

The about 325 to 418 ftc that damaged the pigmented mice in 14 hours are comparable to the irradiation from bilirubin lamps which typically ranges from about 300 to about 600 ftc. Please note that the eyes of preemies still lack all pigment and are in this respect more like those of the albino animals.

Moreover, the human babies' retinal "target tissue" gets exposed during its most active stage of development which makes it even more vulnerable than the already developed and thus more stable retinae of all the mice in these tests.

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.

For your convenience, I attached the relevant pages from these four papers to which the LIGHT-ROP authors refer repeatedly:

  • LIGHT-ROP MOP-2 reference 45, cited on pages 2-9 bottom, 2-10 top, and 2-11 middle: "Separate Mechanisms for Retinal Damage by Ultraviolet-A and Mid-Visible Light" by Rapp, Tolman, and Dhindsa, Invest. Ophthalmol Vis Sci 31:1186-1190, June 1990:

See page 1187 right for severe retinal damage caused to rats by exposures of 4 hours, and the damage getting worse with increasing latency times until examination of 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.]

  • LIGHT-ROP MOP-2 reference 47, cited on page 2-10, line 12: "Damage to the monkey retina by broad-spectrum fluorescent light" by Sykes, Robison, Waxler, and Kuwabara, Invest. Ophthalmol Vis Sci 20:425-434 April 1981:

The abstract reports retinal damage to adult monkeys from single 12 hour exposures to irradiations of 195 to 361 micro-W/cm2 at the retina.  That is only 3 to less than 7 times the 53.4 micro-W/cm2 I computed on page 7 of my book 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 have been found to cause similar damage if the examinations had been delayed. Indeed, on page 432 right, exposure to a threshold retinal irradiance of only 10 micro-W/cm2 for 4 hours from a broad spectrum xenon arc source produced retinal damage when examined 60 days after that exposure. (ROP becomes detectable only several weeks after the birth of the preemie.)

See also page 432 bottom left for damage in many retinal layers of newborn monkeys from 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.  At the bottom of the right column on that same page, see the statement "Thresholds obtained by Ham et al. are based on ophthalmoscopically visible lesions and considerably shorter exposure periods (1 to 1000 sec) than that used here."

Compare further page 433 left, bottom: "The decreased ocular pigment in humans may, in fact, make them more susceptible than the monkey to photochemical retinal damage." Please note that premature babies have virtually no ocular pigment.

  • LIGHT-ROP MOP-2 reference 54, cited on page 2-11, lines 13, 14, and again 17: "Possible Mechanisms of Photoreceptor Damage by Light in Mammalian Eyes" by W.K. Noell, Vision Res 20:1163-1171, 1980:

Table 2 on page 1166 right, top, summarizes that retinal damage in rats was produced by 50 to 200 ftc 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.

Please note that the eyes of human preemies are also abnormally light-vulnerable during the time when the 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 safely assume that preemies might be somehow more resistant.

  • LIGHT-ROP MOP-2 reference 55, cited on page 2-11 middle, lines 10, 14, and 17: "Basic mechanisms underlying the production of photochemical lesions in the mammalian retina" by Ham, Mueller, Ruffolo, et al., Curr Eye Res 3:165-174, 1984:

Already the lead sentence of that article states "Extended exposure (100-1000s) of the macaque retina to blue light (400-500nm) induced a photochemical type of lesion."  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, in that paper).


Considering these references to light damage from short exposures in the LIGHT-ROP authors' own sources, I find it hard to believe that the LIGHT-ROP authors could have missed all these mentions in their supporting documentation 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 suppose that they checked in their sources the durations which produced damage. 

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 in most cases much shorter than 24 hours.  Yet, knowing this full well, the LIGHT-ROP researchers did not patch the eyes of the babies in their allegedly protected group for up to 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 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 possibly 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.

For comparison, I am also attaching the relevant pages from the 1995-1996 Threshold Limit Values (TLVs) for Chemical Substances and Physical Agents and Biological Exposure Indices that are issued annually by the American Conference of Governmental Industrial Hygienists in Cincinnati, Ohio. Similar organizations in other countries issue similar lists that give mostly the same or similar hazard values for each of the agents.

The exposure thresholds for light are based on innumerable animal experiments of the same type as in the LIGHT-ROP authors' citations, and on human clinical data from welding accidents and other injuries from overbright light. As you can see in the attached copies, the TLV definitions separate photochemical injury from chronic blue-light exposures into two categories:

  • those with durations of up to 10,000 seconds, or less than three hours, and

  • those that last longer. There is thus no "injury-free zone" of up to 24 hours as the LIGHT-ROP authors pretend.

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?

Since 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 300 to 600 ftc, can anyone honestly assert 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?

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