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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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Replies from the Children's Hospital of Buffalo
2. Dr. Putnam's letter of August 19 for the IRB

The next item from the OPRR investigation file is the August 19, 1997, letter from Dr. Theodore I. Putnam, Co-Chairman of the Institutional Review Board at the Children's Hospital of Buffalo.

More medical inversions of logic

Dr. Putnam says that "the degree of risk does not appear to be substantial if one is talking about goggles" and thereby unwittingly reveals the shortcomings of his blindered approach to the blinding. He forgets that the issue is not the goggles but the strong risks of harm to the eyes of the babies from the standard nursery lighting -- risks that the LIGHT-ROP authors describe at length in their grant applications and in their Manual of Procedures but that do not appear on the consent form.

Although the OPRR's regulations for IRBs fail to reflect this basic anti-Tuskeegee imperative, the "medical ethics" codes and the laws of this country insist that medical researchers protect their research subjects from any reasonably foreseeable risks in a proposed trial, not just some selected ones that happen to be mentioned in or caused by the protocol.

The researchers and IRBs also have the duty to make sure the consent form gives the research subjects complete information about any reasonably foreseeable risks or discomforts to the subject (45 CFR 46.116(a)(2). The consent must also include a disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject (46.116(a)(4).

Yet, despite the trial authors' description of many known risks from the standard lighting, and despite the easy availability of alternative procedures, such as shading the incubators, keeping the lights low, filtering the eye- damaging short wavelengths out of the fluorescent light, or using incandescent bulbs, Dr. Putnam's IRB goes along with suppressing that information:

"The IRB in reviewing the consent form did not feel that the question of the brilliance of ambient light is a consideration for inclusion into the document. If it were indeed so, then each child's parents would have to be asked whether they want their child admitted to the Intensive Care Nursery based on brilliance of light alone, i.e. the light is a possible hazard when no substantial proof has been offered to establish that fact."

Dr. Putnam seems unaware of this, but each child's parents do indeed have the right to be told about the possible hazards to their baby, whether some willfully ignorant and thus malevolent medical fossils consider these hazards "proven" to their own biased satisfaction or not. The OPRR regulations state in 46.116, "General requirements for informed consent":

"An investigator shall seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence."

Obliging the parents of preemies to accept the bright light just because some dishonest doctors insist on it and conceal the alternatives is clearly coercion.

When our own now blind son was born, my wife and I would certainly have wanted some knowledgeable and honest non- quack to tell us about the potential risks from the light. These risks were well known back then, even though they remained allegedly "unproven" to the self-serving pediatric retinal surgeons who derive much income from the baby- blinding epidemic and insist on keeping the nursery lighting as bright as possible. We would have protected our son more carefully from the glare if we had suspected it of being a hazard.

Dr. Putnam's idea that there has to be substantial proof for a risk before it should be communicated to the research subject (or eliminated for a patient) is clearly at variance with all the official declarations of medical ethics and even with the regulations that the OPRR is supposed to enforce. It also violates the laws of this country that require, according to Black's Law Dictionary (Fifth Edition, 1979, page 701):

"... a full disclosure of the facts needed to make a decision intelligently; i.e. knowledge of risks involved, alternatives, etc. (...) so that a patient, exercising ordinary care for his own welfare, and faced with a choice of undergoing the proposed treatment, or alternative treatment, or none at all, may intelligently exercise his judgment by reasonably balancing the probable risks against the probable benefits."

The fact that an IRB in a major University Hospital can so openly ignore those ethics codes, regulations, and laws tells you much about the futility of the attempt to control medical abuses by doctor-performed and doctor-supervised internal reviews.

The further fact that the OPRR does not challenge this blatant disregard of its rules confirms that the medical ethics bureaucracy is just window dressing designed to deceive the public.

If bright lights are so constantly needed to observe the babies, as alleged, then why can they be dimmed for extended periods without danger?

The OPRR closed its eyes also to the fact that none of those to whom it sent its inquiry answered the first of the two surviving charges in it:

"The degree of risk is substantial, the degree of benefit is minimal or non-existent."

Neither Dr. Reynolds nor Dr. Putnam or Dr. Adams explained any plausible benefits from bright light to premature babies, but when Dr. Putnam tried, he offered a curious example of his self-contradicting medical "logic":

"The lights in our ICN are not always on fully, and the risk to infants were they kept in dim light altogether might be greater by virtue [of] the possibility of failure to recognize danger signs especially related to infant color."

This raises the question: What happens when the lights are not on fully? The consent form which Dr. Putnam's IRB approved tells the parents that

"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."

If the nurses risk to miss danger signs without the full brightness, then how can the nursery doctors in Buffalo tolerate any periods without full light that put the babies at so much risk of not being observed?

On the other hand, if the periods without full lighting do not endanger the babies, and if these dim periods are a nursery routine that causes no practical problems, then why lie to the parents?

Special procedures can be performed with task lighting and eye patches and are no excuse for exposing all the babies to the eye-destroying glare. And why would more light be needed at other times? Do the babies time their seizures and gasping spells to coincide with the hours of bright lighting, and postpone them when the lights are too dim to observe them? Even if that could be claimed to be the case -- would it then not be better for the babies to keep the lights dim all the time?

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