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The non- response of the alleged bioethics guarantors to an inquiry by a member of US Congress
by H. Peter Aleff

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Not all nurseries use bright lights

The bright illumination is not needed for properly observing the babies. Some nurseries keep their rooms dim and protect the babies from stray light. For instance, the above mentioned nursery where Glass et al. so successfully reduced the blinding still has low light levels, as you can see on that video.

So do other nurseries: Mr. Gavzer, the PARADE reporter who is working on a follow-up article about the nursery practices, just told me a couple of weeks ago about some more nurseries, in Kansas City and in Florida, that were quite dark.

You may also remember last summer's Atlantic City Press survey of the local nurseries here that I sent you: most of them draped the isolettes and said they kept the lights low for the rest and comfort of the babies, with one of the neonatologists commenting that bright light makes the babies "squint their eyes and try to move their little heads into the shade".

To further counter Dr. Reynolds' and Dr. Putnam's false allegation that the bright fluorescent nursery lighting is needed to properly observe the babies, please see the attached 8-21-97 letter from Mrs. Helen Harrison, the author of the best-selling "Premature Baby Book".

She relates there a conversation with a nurse according to whom the Children's Hospital in Oakland, California, had replaced in one nursery room all the fluorescent tubes with incandescent bulbs. No one noticed or mentioned a difference, and those who knew the lamps had been changed felt the change had made that room cozier and warmer.

Please see also the attached page from "Aesclepius - The Official Idea- Letter of the Center for Health Design" which informed its readers about the dangers of the fluorescent nursery lighting. Moreover, the editor of that newsletter for health facility designers distributed our material at a symposium of that professional group.

He also told Mrs. Watson, the founder of the advocacy group, "Prevent Blindness in Premature Babies", that those members he spoke with agreed the suggested return to incandescent nursery lamps made sense, and the harsh factory- style fluorescent lamps were anyway unsuitable for baby nurseries.

Did the Buffalo IRB Co-Chairman even read the protocol he rubber-stamped,
and does the OPRR care?

Dr. Putnam concludes with some additional remarks that you may find surprising in the context of a trial ostensibly held to evaluate the risks of nursery lighting:

"Lastly, the IRB does not ordinarily question environmental conditions unless they are specifically part of a research protocol. Whereas the standard is to keep Intensive Care Nurseries well illuminated, we did not single out this rather simple environmental standard as one that should be questioned."

The research protocol of the LIGHT-ROP experiment was specifically aimed at the environmental condition of nursery lighting, and the study was ostensibly set up to question it. Dr. Putnam's cryptic comment is thus at best befuddled, but the OPRR did not ask him to clarify what he might have meant.

Reply from the University of Texas Southwestern Medical Center
Dr. Adam's answer of September 11 for the IRB

The medical confusion about the natural "control" condition for preemies

Dr. Adams, the Chairman of the IRB in Dallas, replied on September 11 to Dr. Cassells that the IRB was only concerned about possible harm from reducing the light exposure and that the standard nursery conditions could not be considered a risk because they were the control condition.

However, he attached the 2-3-92 letter from an outside advisor, a Dr. John Herman, Clinical Associate Professor of Psychiatry and Psychology at the same University of Texas Southwestern Medical Center, who said on his second page:

"... the infants are being deprived of bright light at a time when they normally would be in utero receiving no light. In a sense, the normal control for the goggled infants would be totally patched infants receiving no light."

His own consultant told him thus that the control condition ought to be darkness, but Dr. Adams deliberately ignored that no womb has fluorescent lamps. He also failed to acknowledge that the blue-rich light from these standard nursery lamps has long been known to be the most retina- damaging type of light, and that said standard nursery lighting was never shown to be safe.

To the contrary, this unproven fluorescent nursery lighting is a vast, patient-harming, and entirely uncontrolled medical experiment without any informed consent in which the parents are systematically deceived and coerced into exposing their babies to that unneeded and unnatural and retina-damaging radiation, as if that was some inalterable ritual, like the dunking of newborns into cold water that some primitive peoples used to practice.

This un-womb-like exposure is the pointless and reckless "mad scientist" experiment the IRB ought to have examined, instead of confusing it with a proper control.

Dr. Adams adds that it would be unusual for an IRB to challenge the standard lighting, simply because he and the LIGHT-ROP authors assert that the control is the standard lighting:

"Since the standard lighting is the control condition, it is normally not an issue in the IRB consideration of risk. Rather, the IRB was concerned about the manipulations to the preterms which were not standard procedures."

The standard lighting is the control condition in the same way that untreated syphilis was the control condition to be studied among the Tuskeegee patients.

Dr. Adams shows again that same Tuskeegee- approving lack of concern with known existing risks that Dr. Reynolds and Dr. Putnam had exhibited, and that is in full accord with the OPRR's "Criteria for IRB approval of research" stated in 45 CFR 46.111.

Should consent forms be allowed to lie
to the parents of children to be enrolled
in medical experiments?

I had pointed out in my complaint the lies on the LIGHT-ROP consent form that pretend a non-existing medical knowledge about how much oxygen a preemie should get. Dr. Adams said the IRB would make no issue of the oxygenation since this was not part of the protocol. This is odd since IRBs are required to make sure that

" ... the investigator has obtained the legally effective informed consent of the subject or the subject's legally authorized representative." (45 CFR 46.116)

This implies that the information on the consent forms must be accurate and complete, and it rules out lies and deceptions.

The parent-deceiving misinformation that the doctors know what is "just the right amount of oxygen" should have been the IRB's and OPRR's concern -- if the system was workable. Instead, the government relies on medical doctors to care whether other medical doctors are honest with patients, and it naively pretends to see no conflict of interest in this alleged self-supervision.

Should IRB Chairmen be allowed to lie to the OPRR?

Dr. Adams also alleged on page 2 of his letter that

"The protocol did not call for exposing preterms to high light intensity because of the protocol, since they would receive the standard intensity regardless of their participation."

That statement contradicts the Manual of Procedures for the LIGHT-ROP study which specifically called for the maximization of the babies' exposure and for the denial of the usual protections against excess light such as shading blankets.

The unchallenged contradiction shows you how useless the OPRR is since the doctors who are allegedly being investigated can get away with such open lies. The OPRR did not request Dr. Adams to clarify that contradiction for the Dallas nursery, nor did it inquire about the lighting conditions at the San Antonio and Santa Rosa study sites.

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