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Footnotes :

 

a  American Academy
of Pediatrics and the American College of Obstetricians and Gynecologists: "Guidelines for Perinatal Care 1983, chapter "Clinical Considerations in the Use of Oxygen", pages 212-6 (see page 213).

 

b. BERKOW R, ed. The Merck Manual of Diagnosis and Therapy, Volume 11. Gynecology Obstetrics Pediatrics Genetics, 14th edn. Rahway, New Jersey: Merck & Co., 1982, page 130 (middle).


 


 

  

 

  

  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
   on page

1   2    3    4    5    6    7    8    9   10   11

The LIGHT-ROP researchers
violate the
"first do no harm" rule.

The LIGHT-ROP parental consent form is meaningless anyway since it does not really give the parents a choice: whether they sign this form or not, their baby will be subjected to the nursery-wide extra intensity of retina-damaging irradiation with bright fluorescent light that the study authors mandate and promise to enforce in all the study-site nurseries.

Non-physicians might assume that the study authors' long lists of documented and suspected dangers from light to preemie eyes should be reason enough to protect the babies, to switch off right away the unnatural glare that common sense and parental instinct alone would forbid in what should be a rest-promoting baby nursery.

The LIGHT-ROP researchers follow instead the old saying that the aim of medical science is not to cure or prevent disease but to study it. With scientific detachment, they expose other people's premature babies to the very same radiation that they "have compelling reasons to believe" can harm those babies' eyes. They cannot use animal substitutes but must study the preterm human model because retinal damage from blue and violet light is already redundantly described for all the other test animals, from newborn albino rats to adult homo sapiens, but it remains to be statistically validated and related to ROP with a controlled clinical trial in prematures of that latter species.

The LIGHT-ROP authors omit to mention what benefit preemies might derive from an irradiation that they never needed in the first place and that consistently damages animal and adult human retinae. However, they claim the care personnel need high light levels to observe sick babies and perform special procedures.

As any hospital patient jarred from healing sleep by pre-dawn cleaning crews learns, in the mainstream medical creed the needs of the caregiver outweigh those of the patient.

The LIGHT-ROP researchers' risking the eyes of the babies to better observe these under high doses of specially harmful light similarly illustrates that they and the approving physicians view the profession's "first do no harm" masthead maxim as obsolete and at best ornamental.

How else could the National Eye Institute have approved the LIGHT-ROP study on the entirely unexamined basis that the caregivers needed bright fluorescent lamps to observe the patients, regardless what the blue- light hazard from those lamps might do to those patients?

The consent form lies
about the need for the light exposure

Dr. Spencer claims on pages 3 and 4 of his 5/23/90 comments in the second half of his application that the bright lights are needed, first of all because

  1. "Simply reducing the nursery light would not allow a simultaneous control group (or other treatment groups) to be evaluated in the same hospital nursery room. (...)" [The needs of the study rank clearly above patient protection.]
     

  2. "A second reason for not choosing this option is that it would not allow for masking of either the physicians or nurses involved in the study." [Priority again to the needs of the study even though the here cited need does not exist by the author's own admission : On page 14 of his Research Plan (near the beginning of his application as bound) Dr. Spencer had criticized lack of masking as one of the major flaws in the Glass et al. study where light reduction had significantly reduced ROP.  However, on page 6 of his 5/23/90 comments, he admits that the caregivers in the LIGHT-ROP study can not be masked either.]
     

  3. We were advised by our light toxicity consultant, David Sliney, to have a meaningful reduction in light in the NICU, this reduction should be at least one log unit of the existing amount of nursery light. This would necessitate the light being reduced to about 1/10th of existing levels. This amount of room light reduction was thought by the neonatologists and nursing personnel questioned about it to be potentially compromising to infant care in the NICU. Specifically, this amount of room light dimming might prevent adequate evaluation of an infant's skin color as well as any seizure activity. It might also prevent routine procedures such as insertion of intravenous lines and catheters."

The anonymous neonatologists and nursing personnel questioned in this undocumented collection of personal opinions contradict the supposedly study-based and presumably more authoritative "Guidelines for Perinatal Care" issued jointly by the American Academy of Pediatrics and the American College of Obstetricians and Gynecologists.

As I document on page 14 of my book, these Guidelines state specifically that "skin color cannot be trusted to estimate (blood oxygen) levels reliably".a

The other condition for which skin color is usually alleged to be a diagnostic sign is neonatal jaundice. Yet the Merck Manual of Diagnosis and Therapy, an equally mainstream medical publication, warns that "skin color should not be trusted to evaluate the severity of [neonatal] jaundice".b

Furthermore, the claim to need bright light also ignores studies that find preemies in low- light- level, low- noise intensive care nurseries consistently thrive better, have fewer complications, and can go home sooner.

See, for instance, Dr. T. Berry Brazelton's letter to me on page 62 of my book about the success of this approach in Boston, and the LIGHT-ROP authors' own comparison above between that Boston nursery and the much brighter nursery in Baltimore where the babies suffered one and a half times the Boston incidence of ROP in all stages.

Why select the most harmful illumination available?

Even if, in a strangely topsy- turvy pediatric doctrine, overbright light was somehow needed to better realize the professed neonatologist ideal that intensive care nurseries should strive to simulate the dark womb, it is even harder to explain why this light should have to emit its most intense energy spike in precisely the narrow wavelength region where the mammalian retina is most vulnerable to damage from light.

The offending blue- violet wavelengths can easily be filtered out of fluorescent light with special yellow plastic shields that are commercially available. And with just a fraction of the money spent on the LIGHT-ROP study, all the fluorescent lamps in all the four study nurseries plus many others could have been replaced with incandescent bulbs that emit very little blue or violet and that all the early intensive care nurseries used safely for decades until just before the ROP epidemic began.

How many doctors does it take to change a lightbulb?

The fourth and last reason Dr. Spencer gives for not reducing the overall light level in the nurseries may make sense to him and his colleagues but probably not to many others:

  1. "There are currently no techniques available for reducing light in the nurseries by any standardized method.  Each nursery typically has multiple lighting sources -- overhead fluorescent tubes, incandescent spot lights for more focal illumination, and, in many nurseries, there is sunlight from the outside. These multiple sources of illumination result in uneven lighting conditions within the nursery. Thus, in order to best control the amount of light received by the infant's eye, it becomes necessary to attempt to control the amount of light in the patient's immediate surroundings or place goggles or patches over the patient's eyes."

He ought to have consulted the "1996-97 Guidelines for Design and Construction of Hospital and Health Care Facilities"; these warn in their Section on Lighting that

  • "Consideration should be given to controlling intensity and/or wavelength to prevent harm to the patient's eyes (i.e. retina damage to premature infants, and cataracts due to ultraviolet light)" (Section 7.32.D6., copy enclosed).

If he was uncertain how to control these parameters, then the people who wrote these Guidelines could have explained to Dr. Spencer and all the LIGHT-ROP study reviewers the techniques of light switches, window shades, and light bulbs of different type and Wattage, some fairly standard methods for reducing indoor light levels to any desired and easily controlled level all the way to complete darkness.

But Dr. Spencer et al. admit and casually condone even that sunlight enters many nurseries, as if this confirmed eye- hazard was unstoppable.

Some ancient civilizations used to consider forced staring into sunlight as one of the more barbarian punishments reserved for the worst criminals, but modern neonatologists think nothing of letting the sun shine on preemies who cannot move their head away and whose paper- thin eyelids are virtually transparent.

Dr. Spencer demonstrates this lack of concern over sunlight in preemie eyes four years after the above mentioned Glass et al. study had reported that in a subgroup of babies who had "on occasion" been left lying with the sun in their faces, most had ROP, with only one chance in 200 that this strong correlation was accidental. (See page 8, right, top, in my book).

The Washington, D.C. intensive care nursery where that happened shortly before 1985 has now greatly reduced light levels and an increased awareness of some of the dangers from light, as you can see in the enclosed video during the TV interviews of Dr. Glass in that nursery.

If this nursery, the one in Boston, and a growing number of other intensive care nurseries here and in Canada can reduce their light levels, then there is no reason why those in Buffalo, Dallas, San Antonio, Santa Rosa, and elsewhere should not be able to grant their babies the same relief from the un- womb- like brightness.

Instead, Dr. Reynolds describes on page 88 of his application the participating nurseries in Buffalo and Dallas as suitable for the study because they are both "high light level" nurseries. He says that the choice of these bright nurseries minimizes "the potential large variation in lighting" between different centers. Since few if any nurseries can be even brighter than these "high light level" sites, this "large variation" means that some of the other nurseries are much less bright, and that their staff either do not observe the babies or need less light to do so.

But the consent forms do not tell the parents about this alternative. The Santa Rosa version simply calls the nursery light "normal" and gives no reason whatsoever for its high intensity. The others offer the long debunked myth that the brightness is needed for observing the babies:

  • Buffalo and Dallas: "Reducing light by simply turning down the lights in the nursery would not be practical because of the need for bright lighting to carefully observe sick infants and perform special procedures."

  • San Antonio: "Area control of lighting would include simply turning down the lights in the nursery. This type of light reduction may not be feasible for the LIGHT-ROP Study because of the need for a minimum amount of light in the nursery to allow adequate infant observation, and more light is often necessary for special procedures."

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