Abstract & Summary

Table of Contents
ROP description
Eugenics against oxygen
Slandering oxygen
Oxygen study frauds  
Alleged study results
Later deaths
Futility and harm
Fluorescent ROP lamps
Damaging irradiance
Preemie vulnerabilities
Studies of light and ROP
Frauds in LIGHT-ROP
Cover-up stonewalling


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Bioethics LIGHT-ROP

Bioethics SUPPORT

Bioethics own violations

Bioethics Consent

Bioethics 1955 Oxygen

Unethical Bioethics 1

Unethical Bioethics 2

Unethical Bioethics 3

Unethical Bioethics 4

Hypocritical Nature

False Medical Denials

Pre-Nuremberg Bioethics >>>

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Relapse to Pre-Nuremberg-Code Bioethics
Peter Aleff,   June 1, 2013 



Pre-Nuremberg Bioethics:

Preemies as disposable guinea pigs in recent medical experiments

The U.S. medical researchers in the recent SUPPORT experiment of restricting life-saving oxygen breathing help for premature babies enrolled 1316 children from 2005 to 2009 without informing the parents about the known risks from their research, and the ruthless asphyxiating predictably killed 23 "extra" preemies in their low-oxygen group. This matched the researchers' initially stated concern about the safety of the preemies enrolled in that group, and it came close to the experiment designers' expectation of up to four percent deaths and severe disabilities from less oxygen. Confirming that prediction, they computed a probability of 96 percent that this strong correlation was not a statistical fluke, and they published these preliminary results in the May 27, 2010, online issue of the New England Journal of Medicine.
"Target Ranges of Oxygen Saturation in Extremely Preterm Infants" at].

Almost two years after having been alerted to the serious ethics violations in that knowingly lethal medical experiment on American babies behind the parents' backs, and to the inability of the National Institutes of Health to locate the alleged consent forms the parents would have had to sign to (illegally) expose their children to that fatal risk, as documented at, the U.S. Office for Human Research Protections (OHRP) sent on March 7, 2013, a "letter of determination" to one of the study centers, the University of Alabama at Birmingham, to state that the parents of these babies had not been properly informed about the risks to their children. 
This was not even a slap on the wrist for the same type of reckless subject-killing medical research crime that had led to the establishment of the Nuremberg Code of medical ethics. That Code mandated the welfare of the research subject to be the primary concern in any medical research on humans and forbade any experiment which could risk the death of the subjects; these governing principles were subsequently re-affirmed in several much touted declarations of medical ethics and government regulations.

Despite all this lip service, those solemn rules are toothless because even this mild rebuke from the OHRP against just one of these major transgressions went unnoticed until the consumer advocacy organization Public Citizen  alerted the media about that letter. Even then, many doctors and bioethicists complained about the criticism of this crime, and the top leaders of the National Institutes of Health willfully misrepresented the facts to defend that plainly unethical research.

Public Citizen sent on April 10 an open letter to Health and Human Services Secretary Sebelius to complain about the gross deception in the alleged consent forms. They asked her to apologize to the parents of the 1,316 extremely premature babies enrolled in this unethical experiment [Public Citizen: "HHS-Funded Experiment Exposed Babies to Risk of Death and Blindness Without Informing Parents" at].

However, some mere apology will be of little help to parents who got their baby killed, or else may have to attend for the rest of their lives to a severely brain-damaged child because of this hit-and-run medical research.

On April 11, the equally non-governmental watchdog group Alliance for Human Research Protection weighed in with an article titled "An Experiment Designed to Kill Babies" in which they correctly compared this medical research atrocity with those perpetrated by the infamous Nazi doctors and by the U.S. syphilis researchers in 1946-48 Guatemala as well as with those of the patient-harming ARDS lung experiments conducted ten years ago in the U.S. on unconsenting adults [Alliance for Human Research Protection: "An Experiment Designed to Kill Babies" at].

On April 15, Public Citizen further asked Secretary Sebelius to suspend enrollment in all ongoing trials involving babies and to release the details of their study protocols for review. On May 8, they sent her a follow-up letter with a detailed analysis of the patient-harming SUPPORT research protocol and of the consistently defective consent forms. [Public Citizen: "The Surfactant, Positive Pressure, and Oxygenation Randomized Trial (SUPPORT) – Analysis of the Complete Protocol and Complete Consent Form" at]

The Alliance for Human Research Protection also published additional data on the flaws in the SUPPORT protocol and consent forms. []

These consent forms, the critical cornerstone of all medical research on human subjects, had been uncritically approved by each of the 22 Institutional Review Boards at the participating medical centers although none of these misleading forms complied with the mandatory Federal disclosure requirements

Moreover, the protocol of this experiment prescribed the intentional mis-calibration of the oximeters that were supposed to measure the arterial oxygen saturation levels in the blood of each preemie, and thereby to mislead the care-giving doctor or nurse who is supposed to adjust those levels according to their experience and best judgment of that individual preemie's overall condition. The readouts for the high-oxygen group with a range of 91 to 95 percent were doctored to show three percent less than the actual value, and those for the 85 to 89 percent low-oxygen group read three percent more than what they should have shown. This is like secretly changing a fever thermometer so that it reads a relatively safe 100 degrees when in fact the patient has a potentially fatal 103-degree fever. Misinforming the care givers this way could seriously harm the baby when his or her treatment was not custom-adjusted to the real status.

Yet, those Institutional Review Boards, the main enforcers of the supposedly subject-protecting regulations and alleged defense against medical research abuses, rubber-stamped not only those deceptive consent forms but also this patient-endangering protocol.

These smokescreen protections of research subjects against blatant exploitation by rogue researchers illustrate the worthlessness of the assurances the Presidential Commission for the Study of Bioethical Issues gave last year to the President and to the American public when it unctuously declared the abuses were safely past, and despite a remaining need for some improvements those protections were now adequate. Adding to the disconnect between words and deeds, the Universities headed by the Chair and the Vice-Chair of that Bioethics Commission were both participating in this premeditated sacrifice of 23 preemie lives on the altar of medical science. See
The public revelations about the parent-deceiving consent forms were countered by vehement denials from some of the researchers and other medical apologists. They all asserted rotely that nothing wrong had happened. Even the editors at the traditionally respected New England Journal of Medicine (NEJM) and at the Journal of the American Medical Association (JAMA) as well as some professional bioethicists and three top leaders at the National Institutes of Health joined that cover-up chorus. Instead of acknowledging the documented evidence of the researchers' willful deceits and the actual deaths as well as the risks of brain damage these had knowingly inflicted on their vulnerable subjects, those medical wagon-circlers ignored their mechanically proclaimed mantra that the public's trust in medical researchers can only be earned by consistently telling the truth. Instead, they upped the ante and continued their attempts to glibly distort the easily verifiable facts.
As an example of those whitewash fabrications, let me cite here a typical entry, the article "Risk, Consent, and SUPPORT" by David Magnus and Arthur Caplan, two renowned bioethicists and original authors at Their article includes most of the arguments made by other defenders of this current  medical atrocity and was published in the May 16 issue of the NEJM [].  
They claim that in an experiment of the SUPPORT type, "there is no additional risk to being randomly assigned to one or another equally well supported treatment option that falls within the standard range of care in clinical practice". They also said: "it has been argued that the research should have been eligible for a waiver of documentation of informed consent, since there was no basis for claiming an increase in risk from enrolling in the trial versus receiving standard clinical care".
However, the very purpose of the entire experiment was to refine the quantification for the broadly known relative risks of death and brain damage versus mostly blinding for the two groups, and the SUPPORT researchers themselves had written that "the safety of low target levels of oxygen saturation remains a concern.” They were well aware of the added risk of death and serious brain damage to the infants receiving oxygen only in the lower half of the typical range. They cited a British report from 1973 that the routine oxygen withholding practices introduced 17 years earlier had by then led to an estimated 16 deaths for each case of blindness prevented. Similarly, the authors of the NeOProM umbrella study proposal, which included the SUPPORT experiment as well as four similar studies in other countries, mentioned a medical estimate of 150,000 preemies killed by oxygen restrictions in the first 20 years after the largest of these oxygen-withholding studies and its knowingly fatal recommendation to withhold much of the life-saving gas.
(Actually, this often cited professional estimate of the death toll from this Herod-dwarfing massacre of gasping newborns by American doctors appears to be low-balling the real number of victims even for just the U.S. alone. See  
The SUPPORT authors expressed the hope that better measurement techniques would meanwhile allow to improve this outcome, but the examples they cited did not back up their argument. They summarized a limited sample of studies in which lower oxygen levels had correlated with lower incidences of blinding, but for most of these the mortality had not been reported, and in at least one of them a tighter monitoring of this breathing help had increased the number of deaths by 8 to 11 per cent, depending on the birth weight group, with a probability of only 6 percent that these increases could be statistical flukes
[Bancalari E, Flynn J, Goldberg RN, Bawol R, Cassady J, Schiffman J, Feuer W, Roberts J, Gillings D, and Sim E. Influence of Transcutaneous Oxygen Monitoring on the Incidence of Retinopathy of Prematurity. Pediatrics, May 1987, 79: 5: 663-669, see page 664 right, middle].

Unfortunately, medical doctors are trained to consider a correlation as significant only when that probability is five percent or less, a mindless practice which some have called a "clumsy substitute for thought". Although this arbitrary definition of significance does not even apply to questions of safety where even a weak association should become an alarm signal, the oblivious authors of that study did not interpret those extra deaths as a warning against tinkering with the oxygen supplements. Their lead author even said in a JAMA editorial that the 2.7 percent mortality increase in the low-oxygen group of the parallel Canada-led COT experiment "did not reach statistical significance":

"In the midst of the COT and BOOST II trials, pulse oximeter software was updated to correct a 2 percent overestimation in the 87 to 90 percent saturation range. BOOST II showed significantly higher mortality in infants in the lower saturation target group after the revised software was implemented. Data from infants enrolled in COT after the pulse oximeter software update showed 2.7 percent higher mortality in the lower compared with the higher saturation target group. However, this difference was due to a decrease in mortality in the higher saturation group rather than a change in the lower group with the new software. This difference in mortality did not reach statistical significance but is in the same direction as in SUPPORT and BOOST II." [Eduardo Bancalari, MD; Nelson Claure, MSc, PhD: "Oxygenation Targets and Outcomes in Premature Infants", JAMA. 2013;309(20):2161-2162. doi:10.1001/jama.2013.5831,]

Downplaying in this comparison the higher mortality from lower oxygen saturation as being due to the lower mortality with higher saturation may satisfy the contortions of medical logic but still does not change the fact that less oxygen resulted in more deaths than more oxygen, even if expressing this as less mortality from more oxygen may sound better.

Moreover, contradicting all the pious post-hoc assertions that the differences in mortality had been unexpected, the authors of the NeOProM umbrella study proposal had already stated clearly:

“… none [of these five trials] individually will be able to exclude the possibility that the expected valuable short term benefits associated with giving babies less oxygen are not associated with a small but significant 4 per cent increase in death or serious neurosensory disability in survivors.”
Askie LM, Brocklehurst P, Darlow BA, et al.: “NeOProM: Neonatal Oxygenation Prospective Meta-analysis Collaboration study protocol”, BMC Pediatrics, January 17, 2011, as posted at]

This means the researchers knowingly risked the lives of their research subjects to see if they could reduce the combined total of deaths and cases of blindness with a procedure known to greatly increase the risk of death. They disregarded the Nuremberg Code which states in Article 5 that

“No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur”.

Similarly, the Helsinki Declaration of Medical Ethics summarizes in its Article 6 the physician's duties to promote and safeguard the health of subjects involved in medical research:

“In medical research involving human subjects, the well-being of the individual research subject must take precedence over all other interests.”

Unfortunately, their alleged concern for the safety of their subjects in the low-oxygen group did not keep the experimenters from giving precedence to their research over the well-being and even survival of their subjects.

The SUPPORT result of 23 "extra" deaths in the low-oxygen group amounted to 3.5 percent of that group, so the researchers' prediction of up to four percent had been fairly accurate, except that it still omits the victims of the severe brain damage also to be expected from the oxygen restricting. However, it confirmed their well-informed expectation of extra deaths. Yet, the apologists for medical murder want to assure us that this pre-meditated sacrifice of victims in the low-oxygen group was unexpected and that there had been "no basis for claiming an increase in risk".  

The "Risk, Consent, and SUPPORT" bioethicist authors further repeat the already debunked claim that "the study also included a non-randomized case-control group which proved that patients enrolled in the study did better than patients who were not enrolled. As Public Citizen and the Alliance for Human Research Protection had already pointed out in their initial reactions:
"But his statement is false and meant to mislead reporters and the public. In fact, this assertion is belied by the SUPPORT researchers’ own published report in the journal, PEDIATRICS ( March 2012). The authors compared key clinical factors for the 1,316 babies enrolled in the study and 3,054 premature babies not enrolled in the study, but eligible. They presented baseline data in 3 tables showing that the non-enrolled group of babies were sicker and at greater risk of death at birth—requiring significantly more life-saving interventions in the delivery room—than those in the SUPPORT study. So it was reasonable to expect that less of the infants who were sicker at birth would survive."
Repeating this knowingly false statement about an alleged control group does not make it any truer, except perhaps in those bioethicists academic medical method of proof by frequent assertion. However, this cavalier attitude towards facts among some of the leading proponents of "medical ethics" may give some members of the public serious second thoughts about how trustworthy a medical profession can be that tolerates and perpetuates such self-serving dishonesty in denying a blatant abuse.

Next comes those bioethicists' misrepresentation that
"The consent documents state clearly that there is randomization, that the randomization is to specific oxygen levels, and that there is some evidence of a risk of blindness with higher oxygen levels."
This is a plain lie. According to Public Citizen's analysis of all 22 consent forms, only two of them disclosed that babies randomized to high oxygen levels were at increased risk of retinopathy and blindness, and none of them mentioned that death was a predictably increased risk for babies in the low-oxygen group. 
These dishonest bioethicists further claim that
"The OHRP finding that the researchers failed to adequately inform the infants' parents is grounded in the mistaken assumption that there was an increase in risk to being enrolled in the trial".
This was not a mistaken assumption. The SUPPORT authors themselves had admitted their concern for the safety of the children enrolled in the low-oxygen group, and the experiment designers had predicted the higher risk quite accurately. However, contrary to all the solemn declarations of medical ethics and their legal obligation to obtain informed consent to their proposed research, the SUPPORT consent forms did not mention this concern to the parents, and only unethical medical ethicists can defend such a callous and illegal deception.

The experiment designers had also suggested that the full disclosure of the risks from proposed research "may impede the conduct of valuable research".

Indeed, if any of those researchers had to disclose this well known significant risk of death and severe brain damage from less oxygen, they would not be able to enroll any babies in an experiment designed to trade one of those risk groups against the other. No parent would knowingly have offered up their child for a research project that could potentially kill her or impair her brain, merely in the unproven hope to maybe protect her from eye damage and other non-fatal conditions. Nor could those parents have agreed legally to this unnecessary risk because any decisions they make on behalf of their child must be in his or her best interest.

Unlike these reckless researchers, any parent knows that death is not on the same level as blindness, and that even intact eyes would be of no use in a dark coffin. Also, no informed parents would freely chose the risk of being burdened for the rest of their lives with the care for a brain-damaged child, plus the constant worry about how to assure that care after they themselves no longer can provide it. 

The planners could not openly advocate to keep the parents in the dark about their experiment, so they did it in veiled terms and approvingly quoted in their 2003 proposal for the experiment a passage from a 1998 paper:

"Collecting less information may mean bigger numbers and hence better science: many trials still collect ten or a hundred times too much information per patient, often at the behest of study sponsors or their committees. Requirements for large amounts of defensive documentation imposed on trials by well intentioned guidelines on good clinical practice (or good research practice) or excessive audits may, paradoxically, substantially reduce the reliability with which therapeutic questions are answered, if their indirect effect is to make randomised trials smaller or even to prevent them starting." [Cole CH, Wright KW, Tarno-Mordi W, Phelps DL: "Resolving our Uncertainty about Oxygen Therapy", Pediatrics, December 1, 2003, pages 1415-19, quote on page 6 of pdf.]

The only "defensive documentation" imposed by those guidelines that could have reduced participation in a trial or prevented it entirely is, of course, the "informed consent" form that properly describes the potential risks from the research project to each participant in it.

The lack of information about these fatal risks on the parental consent forms was therefore not due to any alleged ignorance of those risks on the part of the researchers, or to their now pretended incertitude about them, but rather to their planned obfuscation of the well known risks because revealing these honestly would have kept their deliberately patient-harming experiment from being conducted.

Most prominent among those who are now trying to condone deliberately fatal research on humans without their informed consent are the Director of the U.S. National Institutes of Health (NIH) and two of his top executives there, the Deputy Director for Science, Outreach, and Policy, and the Director of the National Institute of Child Health and Human Development. These top officials saw nothing wrong with the lack of consent and tried to cover up the SUPPORT researchers' crime of knowingly asphyxiating 23 human babies for "science". 

In their June 5 paper in the NEJM, "In Support of SUPPORT -- A View from the NIH", posted at, they even willfully misrepresented the clinical literature in their attempt to hide the ethics and legal violations.

Like the above bioethicists, these NIH leaders claimed that restricting the usual range of oxygen levels in two groups at 85 to 89 and 91 to 95 percent was the equivalent of the standard of care which recommended that full range of 85 to 95 percent, and that there was therefore no difference in risk between the groups although the experiment was conducted specifically to compare that allegedly non-existent difference. This self-evidently bogus claim is like saying that a starvation diet is the equivalent of a normal food intake because the hunger-suffering group gets a calorie count that falls within the range of normal feeding quantities, never mind that it is only at the lower end.

Yet, those NIH leaders and assorted "bioethicists" want to assure us that this pre-meditated sacrifice of the victims in the low-oxygen group was "unexpected" and that there was "no basis for claiming an increase in risk" in the oxygen-starved group, or for telling the parents about the lopsided trade-off in harm the SUPPORT researchers were testing on their children. The researchers' stated end result of "one additional death for approximately every two cases of severe retinopathy that are prevented” is like exchanging a dollar of death for two pennies of blindness.

The contortions of the NIH apologists even become dangerous when they claim that

"The more recent studies showed no increased risk of death or neurodevelopmental impairment at saturation levels as low as 70 percent."

Either these top U.S. Health officials cannot read a clinical paper, or else they know they are spreading potentially lethal misinformation. The one study they cherry-picked to represent those alleged "recent studies" was Tin W, Milligan DW, Pennefather P, Hey E. "Pulse oximetry, severe retinopathy, and outcome at one year in babies of less than 28 weeks gestation", (Arch Dis Child Fetal Neonatal Ed 2001;84:F106-F110). It included a group with a nominal oxygen saturation range of 70 to 90 percent, but its authors explain clearly that this was not the actual saturation. See their pdf page 1 right, bottom, and continued on page 2 left, top: 

"Staff always aimed to maintain saturation in the top half of the target range (particularly when the lower limit of this range was less than 85%). No formal attempt was made to document how often saturation fell outside the recommended management limits, but review of a random sample of case notes quickly showed that narrowly set limits were broached much more often than wider limits, and that staff occasionally responded in this situation by “muting” the saturation alarm altogether."

Another major difference between the groups was that all of those in he high-oxygen group, with 88 to 98 percent saturation, had an arterial line inserted for regularly making sure the arterial blood saturation stayed below the upper target limit. By contrast, only four out of the 65 babies in the low-oxygen group had that tube inserted to keep them from exceeding their upper limit. In other words, they could have spent much time with oxygen levels even above their 90 percent limit, particularly when the alarms were muted. Despite the low nominal 70 percent bottom of that theoretical range, the babies assigned to that group were therefore unlikely to ever have been anywhere near that alleged 70 percent saturation for any length of time.

Moreover, three of the SUPPORT researchers had written in a September 23, 2010, letter to the editor at the NEJM, posted at

"Our preliminary unadjusted analysis indicates that infants who died spent a higher proportion of time (P<0.001) with saturations below 80 percent". 

In other words, saturations below 80 percent were found highly likely to be associated with death, but three top officials at the NIH recklessly and falsely pretend that even 70 percent is a safe level. They clumsily try to obfuscate the well known and widely documented mortality risks from restricting oxygen to preemies, and to cover up the SUPPORT researchers' irresponsibility of having exposed hundreds of children to this increased danger. This increase in risk killed 23 of the preemies and left a still unknown number among them with severe and permanent brain damage, courtesy of the SUPPORT researchers who failed to tell the parents anything about those risks.

Even worse, the NIH leaders propose to hobble the OHRP's ability to do its job by an appeals process that obliges them to consult "independent experts" although all acknowledged "experts" will by definition have to be vetted by and dependent on the NIH. They also forced that watchdog agency to retreat from its criticism of the non-informing "informed consent" forms, as described in the June 10 article by Bob Grant:

"Leaders of Infant Trial Will Not Face Sanctions: US watchdog drops plans to discipline researchers who failed to disclose the full risks of an experimental trial conducted with premature infants".  []

(That title was changed on June 11 to now read: "... Will Not Yet Face Sanctions: US watchdog suspends plans ...". The explanation for this change is that "the OHRP has only suspended activities to decide appropriate corrective actions until a public meeting is held to explore the complex matters raised in this case." Seeing how long it took this "watchdog" to figure out that the consent forms had omitted to mention any of the well known major risks, and that this omission violated clearly written Codes of ethics which are unlikely to get changed by a public meeting, don't hold your breath while waiting for those "corrective actions" to happen.)

This kind of systematic deceit is not an isolated case but one of the foundation principles of bioethics. Indeed, medical anthropologists have long shown that all systems and declarations of so-called "medical ethics" from different periods and regions are merely
"efforts to support professional control by reassuring the public that practitioners will use medical resources in morally responsible ways." [Richard W. Lieban: "Medical Anthropology and the Comparative Study of Medical Ethics", citing Unschuld 1979 and Freidson 1970, pages 221 to 239 in George Weisz, editor: "Social Science Perspectives on Medical Ethics", University of Pennsylvania Press, 1990, see page 235 for quote.]
In other words, those unctuous denials by researchers, editors, bioethicists, health officials, and other medical apologists about any wrongdoing in the SUPPORT experiment are just obfuscations to hide from the public what some researchers still routinely do to their victims in the name of science.

The current U.S. practice of dealing with its medical research crimes is to ignore and deny them while they are happening and to offer public apologies for them decades later.

For instance, U.S. President Obama and Secretary of State Hillary Clinton apologized publicly to the government and people of Guatemala for the unethical experiments six decades ago when American doctors had infected unconsenting subjects there with syphilis. They did so right while the unethical medical SUPPORT experiment of deliberately withholding a known treatment from the low-oxygen group was still underway, with the active cooperation of the Universities led by the Chair and Vice Chair of the Presidential Commission for the Study of Bioethical Issues,

Similarly, President Bill Clinton offered public apologies for the then also decades-old infamous Tuskegee study of withholding a known treatment, and for the equally infamous Human Radiation Experiments conducted in the 1950s and 1960s on humans without informing their subjects about the risks. He offered these regrets right while the fraudulent LIGHT-ROP bogus trial was still going on to distort the medical doctrine with intentionally false information, and without having informed the parents about the reckless risks to their children. [ and]

It is time to get serious about actually ending such blatant and major violations of medical ethics instead of cynically condoning them and only talking about long past examples. Or else several decades from now the then U.S. President will have to show public contrition for the crimes in the current SUPPORT experiment right while his or her health officials will be conducting some similar medical research atrocity, probably also again with the active cooperation of the then blue-ribbon Bioethics Commission's leaders.


It is also time to remove the fluorescent nursery lamps and to end this well documented but willfully ignored danger to still developing eyes. Or else preemies around the world will continue to get their retinas fried by the blue-light hazard. Many of them will continue to go blind from ROP, and this major cause of childhood blindness will continue to feed an industry of pediatric retinal surgery at the expense of the victims and their families. []

And in the current era of "evidence-based medicine", it is long past time for nursery doctors to start heeding actual evidence about oxygen instead of old defamatory rumors that were maliciously spread by long discredited eugenicists. []

Or else the nursery doctors will remain stuck with their irrational and preemie-harming obsession of linking the ROP eye damage to life-saving oxygen. They will keep restricting that necessary breathing help and stage yet more and ever bigger trials and keep treating preemies as guinea pigs. They will keep barking up the wrong tree in the wrong forest, still trying to figure out what they should be doing. And many future preemies will keep dying or getting their brains stunted by the same old and deluded "better dead than blind" dogma of their evidence-disdaining doctors.


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