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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
1. Dr. Reynolds' letter of August 11

Dr. Reynolds, the project director of the LIGHT-ROP study, answered on August 11 per enclosed copy of his letter and some of his attachments.

A Tuskeegee-size loophole
in the Internal Review Board regulations

Dr. Reynolds believes the LIGHT-ROP trial is ethical because it does not introduce a new risk. This attitude complies indeed with the OPRR's "Criteria for IRB approval of research".  Incredible as this may seem after the President's public apologies for the Tuskeegee study that had also not introduced any new risk for its subjects but had failed to protect them from an existing and preventable one, the IRB regulations are still not concerned with the prevention of known existing risks.

The Multiple Project Assurance of Compliance with DHHS Regulations for Protection of Human Subjects that guides the IRB decisions in Buffalo and Dallas is in both cases based on Title 45 in the Code of Federal Regulations, Part 46, 46.111 (2) which states those criteria:

"In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research)."

This illustrates a fatal failure of the IRB process. If one of today's IRBs had to review the Tuskeegee study protocol and followed the above instruction, then its distinguished members would again worry only about the possible risks added by the researchers periodical examinations of the subjects, and not about the known and much greater risk of letting the ongoing harmful condition continue.

With this limitation of the IRB to the evaluation of only new risks, the protocol of the Tuskeegee study would fully meet today's criteria for unconditional approval. If the paperwork for it were submitted in the required number of copies, that infamous study would proceed today as it did then. After all, the Tuskeegee researchers did not infect the study subjects with syphilis but only withheld the available protection against that pre-existing risk.

This resembles what the LIGHT-ROP researchers did when they withheld the available protection against the nursery light which they themselves had described as a strongly suspected risk. The nursery case is worse, however, in the sense that the blinding risk is not a patient-acquired condition, as syphilis is, but a iatrogenic condition that the nursery doctors themselves needlessly impose on the babies, simply because they refuse to acknowledge the known dangers from excess light to mammalian retinae. Yet, none of the alleged anti-Tuskeegee watchdogs barks.

Dr. Reynolds, his colleagues, the alleged guardian boards and agencies against medical abuses, and the Federal Regulations -- all these ignore the physician's basic responsibility to protect the patient not only from new risks but from any reasonably foreseeable risks and discomforts, even the remotely possible ones as the Nuremberg Code puts it.

The risks from the illegal protection- withholding in Tuskeegee would thus still fall through this giant loophole in the current patient protection regulations, just as the risks from the illegal withholding of protection in the LIGHT-ROP experiment did.

How can anyone trust the government's "never again" assurances when its present "safeguards" against unethical medical experiments still allow the bioethics bureaucracy to routinely bypass those lofty pronouncements and to approve repetitions of the very same medical crimes for which the government keeps apologizing?

I suggest you introduce a motion to make these apologies an annual ritual, to be performed each year for the preceding year's abuses, and to schedule this ceremony appropriately on April Fool's Day.

Would it not make more sense to prevent these transgressions in the first place? The case at hand shows clearly that the present alleged self-controls of the medical community are not designed to protect the public but to deceive it.

Avoiding to answer the fraud charge

Dr. Reynolds cited in his letter to the OPRR the usual studies that concluded light made no difference although he and the OPRR know that these all had the same flaw of protecting the eyes of the babies much too late to make any difference. It is the researchers' job to know about and avoid such fatal flaws. In addition, I had informed Dr. Reynolds' sponsors, his LIGHT-ROP co-author, and the OPRR about it.

Dr. Reynolds omits entirely to address the easily verified fact that the LIGHT-ROP delay before protecting the eyes of the babies is much too long to prevent the light damage his trial alleges to study. He glosses over this entire issue and my documentation of his willful fraud in this timing (See, for instance, pages 17 to 21 in my 1-7-98 letter to Dr. Feinstein; I had sent that same information to Dr. Cassells at the OPRR on August 12, 1997).

Neither the National Eye Institute, nor the National Bioethics Advisory Commission, nor the IRBs, nor the OPRR care about the fraud or about the risks to the future preemies who will be mistreated and seriously injured by the nursery doctors' following of the misleading doctrine derived from that fraud in medical research.

To explain the delay in granting the babies their eye protection, Dr. Reynolds only repeats the paternalistic and patently false assertion that Dr. Karl Kupfer, the Director of the National Eye Institute, had given to PARADE (see pages 23 and 24 of my letter to Professor Feinstein):

"We obtained consent at a time when the mother could actually give an informed consent, and not during active labor when she is concerned about her baby's survival and is clouded by pain, medication, and bewilderment."

Please see pages 23 and 24 of my letter to Dr. Feinstein for a discussion of how phony and presumptuous this ad-hoc-invented pretext is.

Disparaging the study
that lowered the blinding by lowering the lights

Dr. Reynolds repeats the usual obfuscating charge of scientific flaws against the one study (Glass et al. in 1985) where the nursery staff had not only shielded the individual isolettes but had in addition lowered the overall light levels in the nursery and placed big red signs in the nursery that reminded the nurses "Cover baby's eyes when using lamp".

You can see the relative darkness in that nursery and the signs on the video of 1989 TV shows about this issue which I sent you last summer and which contains footage filmed in one of the two nurseries where that study was held.

By so reducing the median light levels for the babies from 60 foot-candles to 25 ftc, and by paying attention to stray light, the staff of that nursery reduced the incidence of the blinding among the most vulnerable group of preemies from 86 per cent to 54 per cent. They stated the overall probability was only one chance in ten that this clear association could have been a fluke. Conversely, they found nine chances out of ten that the lowering of the lights was related to the lower rate of blinding. In some of the subgroups, the correlation was even stronger.

It used to be a principle of common sense and of pre-bioethical medicine, that when you suspect a hazard and remove it, and the patient gets better, and that hazard is not needed anyway, you keep that hazard away.

If parents were honestly informed about these probabilities of risk to their baby's eyes from the brighter lighting, they would obviously chose the darker and less blinding environment and make sure the blankets stayed all the time on their baby's isolette. They would probably also question how anyone in their right mind could even consider keeping babies under those bright lights after learning about the risks associated with them.

Unfortunately, light-promoting bioethical pediatric retinal surgeons such as Dr. Reynolds and his LIGHT-ROP co-author Dr. Spencer dismiss that Glass et al. study as allegedly unscientific. Their usual charge against it is that this was a "before-and- after" study where changing an overall condition had produced an overall improvement. See pages 121 to 124 in "The Medical Ethics Trap ..." for my comments on this study and its goal-inverting medical interpretation.

In Dr. Reynolds' opinion -- which only reflects the equally absurd medical mainstream mentality -- the babies should not be protected from that hazardous and unneeded light, never mind the drastic improvement obtained with the Glass study's simple, natural, and safe reduction of the hazard.

The pediatric retinal surgeons who proposed the LIGHT-ROP trial are against granting such relief to the preemies until a correlation between the unnatural bright light and the income-generating eye damage from it is "scientifically proven".

Their "science" requires controlled clinical trials where the exposure is simultaneously reduced for one group and intentionally maximized for the other to obtain "a better contrast between the study groups".

Even the LIGHT-ROP study is not expected to settle the issue but only to lead to a larger-scale version so that the researchers can then measure the dose-response relationship between the light and the blinding. How else could these nursery doctors ever learn exactly how much light it takes to blind a baby partially, and how much more to complete the job?

This callously inhuman approach of using human babies as the expendable guinea pigs for a sick and pointless scientific curiosity is, of course, a gross violation of ethics and laws.  It is also the routine nursery doctor approach, and the medical government officials paid to protect the public from such violations help to cover it up.

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