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Footnotes :

 

7 Cited as Ref. 55: Ham WT, Mueller HA, Ruffolo JJ, et al: Basic mechanisms underlying the production of photochemical lesions in the mammalian retina. Curr Eye Res 3:165-174, 1984. For the experiment with varying latency periods see page 169 right, top.

 

 

8 see pages 181 to 187 in my book, and Section 3.7. on page xv where I discuss how the clinical paper about this German trial deliberately misleads about the timing of the protection to make it appear the babies were protected from birth when in fact they were not.

 

 

9 see Reynolds page 79, and page 132 in my book

 

 


 


 

  

 

  

  Greatly fanfared government watchdogs

 

never meant to do their job

 
 

Davidpreem03.jpg (16608 bytes)

My complaint to the National Bioethics Commission, and that sham Commission's indifference
to real abuses 
 
by H. Peter Aleff

  You are
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1   2    3    4    5    6    7    8    9   10   11

The LIGHT-ROP researchers
intentionally maximize the harmful exposure

Drs. Reynolds and Spencer do not let the well-known existence of successful low-light-level nurseries interfere with their study plan. They have the nursery staff fit the babies in the study group with light-shielding goggles and expose the babies in the control group not just to the typical nursery light dose but to the fullest possible intensity of that retina-damaging irradiation. They even specifically forbid the usual protections for those babies' eyes so as to better differentiate their rate of blinding from that in the shielded group.

Dr. Spencer had assured me in his letter of March 27, 1993 (see page 159 in my book) that

"... under no circumstances will any child in this study ever be exposed to increased amounts of light, nor will the study in any way dictate what the lighting conditions (either bright or dark) are to be maintained in participating nurseries."

However, the protocol of the LIGHT-ROP study forbids any lowering of the intentionally bright light levels, even at night, and denies the babies even the shading blankets that concerned parents or compassionate nurses often drape over the isolettes to protect the inmates at least somewhat from the harsh and unrelenting glare. In Dr. Reynolds' words on his page 72:

"The participating neonatologists have agreed to maintain the current lighting practices at each center. All nursery personnel will be instructed in this to assure compliance. No intentional draping of isolettes or alteration of room lighting will be allowed. The Buffalo and Dallas nurseries both use bright, round the clock lighting. This intense level of illumination should allow for the maximum separation between controls and goggle subjects in the amount of ambient light received."

He affirms again on page 89 top that the nurseries will be continuously monitored with elaborate light meters for "unauthorized reduction in ambient lighting" to make sure the preemies in the control group are exposed to no less than the maximum achievable amount of light and will thus better display the expected harm to be studied. The Manual of Procedures insists:

"In some neonatal nurseries, it is common practice to periodically drape the incubators with blankets to shield the infant from environmental light. This practice will be actively discouraged by the SCC and the investigators in the participating unit." [page 5-4 top]

"We will be able to detect any unauthorized alteration in ambient lighting either by unit (e.g. turning out the lights) or by infant (e.g. isolette draping). This will help ensure a proper stratification of lighting exposure between treatment and control infant. If the monitors reveal such tampering with ambient light we will move to correct this. The Buffalo and Dallas centers are currently brightly illuminated nurseries. Our participating neonatologists have agreed to continue these standards throughout the study period. Ambient light monitors will help ensure compliance by the nursing staff." [pages 5-5 bottom and 5-6 top]

The consent forms do not tell the parents that draping is verboten. So, when these spread a shading blanket over their child's isolette and the Study Center Coordinator "moves to correct this", the person who pulls away the protective blanket would have to explain to the parents the concepts of "maximum separation" and "proper stratification":

"We want to expose your baby to as much as possible of the radiation that we suspect to damage her retinae so that she is more likely to go blind if our suspicions are right."

The researchers develop rapport
with the parents to better deceive them

Since no parents would knowingly allow this to be done to their baby, the Study Center Coordinator must rely on deception. In the words of the Manual of Procedures, page 7-2:

"Adequate rapport must develop between parents and SCC. This is absolutely essential to ensure enrollment and continued participation in and cooperation with the study. Parents will frequently turn to the SCC for clarification or confirmation concerning the rationale of the study. Therefore it is extremely important that the SCC be a mature, responsible person and have a thorough understanding of the protocol study design and reason for the study. (...) The SCC and PI will be responsible for obtaining informed consent and guidelines and examples will be used to teach proper techniques in achieving this goal."

How can the parents give their informed consent freely if the researchers manipulate them with "proper techniques in achieving this goal"?

The LIGHT-ROP study is a scientific fraud
to cover up a routine malpractice

The fraud in the LIGHT-ROP study goes deeper than keeping parents in the dark about the risks to their babies from light and then exposing those babies deliberately to a maximum of known harm. The study design makes it clear that its purpose is to falsely exonerate the current nursery lighting.

The LIGHT-ROP authors describe 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, is at first similarly latent and develops some time after the relatively short exposure. Typical exposure times that produce photochemical retina lesions in animal experiments range from 10 to 10,000 seconds (see page 7 right in my book), and latency times until the development of the lesion are reported from a few hours to several weeks.

For instance, in the reference which the LIGHT-ROP authors cite on page 2-11 of their Manual of Procedures for the cell-level damage from light-caused free radical reactions7, the lead sentence says:

"Extended exposure (100-1000s) of the macaque retina to blue light (400 to 500 nm) induced a photochemical type of lesion."

The term "extended" for these exposure times from barely two to less than seventeen minutes compares these durations to the even shorter times required for thermal lesions which are induced in a few seconds, as when staring into the sun, or split seconds when looking at certain powerful lasers.

As to the latency times, the same article describes a few pages later a series of experiments in which the lesions inflicted latently by such relatively brief exposures were left to develop for periods from 24 hours to 56 days before the retinae were examined.

Knowing full well that the critical light exposure times for the suspected photochemical reaction are measured in seconds and minutes, the LIGHT-ROP investigators provide the babies in the allegedly protected group with goggles only up to 24 hours after birth -- several magnitudes too late for avoiding gross overexposures.

They are quite aware that the babies' retinae can receive the adult danger limit dose in just a few minutes, and that a dose established as dangerous to adults must be deemed even more dangerous to preemies. In addition, they know that an almost identical delayed-goggle trial in Germany a few years ago produced no significant difference between the "protected" and unprotected groups8.

The LIGHT-ROP trial data can therefore be expected to show no significant difference between the two groups either. Dr. Reynolds says for this outcome on his page 72:

  • "Even a negative trend would be worthwhile if it helped put an end to unwarranted speculation and unscientific nursery practices."

and the Manual of Procedures elaborates on page 2-9:

  • "If unsuccessful, a social, political, and medical debate will be put to rest which otherwise will continue to unduly occupy the attention and effort of the public, politicians, hospital personnel, and medical researchers."

In other words, the predictable case of the "worthwhile" outcome with no ROP difference between the groups will make it easier for the study sponsors to continue their denials of the role the nursery lighting plays in the ongoing blinding epidemic. It will back them up with the ex cathedra authority of a multi-hospital American clinical study.

The nursery lamps will therefore steadily continue to sear the retinae of many babies. That irradiation will maintain the steady stream of some 3,500 or more patients per year9 from which many pediatric ophthalmologists and retinal surgeons will continue to derive steady incomes. For them, all will thus steadily continue to be at its best in this best of all possible worlds.

However, even if by surprise the results showed an ROP difference between the two groups, such a finding would still not condemn the nursery lights but only "support the scientific rationale for proceeding with a large trial" (Reynolds page 78 top). This larger trial would then

"potentially allow for the study of different filters of various amounts and wavelengths of light, although this is not planned in our initial study" (Spencer page 6 of 5/23/90 memo in the second half of his tome)

whereas the current feasibility study is too small to answer many of the researchers' questions. Dr. Reynolds says on his page 76 that

" ... [the scaled-down LIGHT-ROP study] will enroll too few patients to study any other secondary outcome e.g. subgroup analysis by birth weight, racial differences, threshold ROP, or light dose response curves."

So, even in the case of the unexpected outcome, the additional research, particularly the study of light dose response curves to different wavelengths in the eyes of different preemie subgroups, might provide another couple decades worth of grants and papers and patients and delay. How else could medical science ever learn to quantify the precise amount and type of light it takes to destroy the retinae of a given baby?

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