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Studies of light and ROP
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Unethical Bioethics 1

Unethical Bioethics 2

Unethical Bioethics 3

Unethical Bioethics 4

Hypocritical Nature

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Unethical Bioethics
Peter Aleff, 2097 Cottonwood Drive, Vineland, NJ 08361, USA,
prevent@retinopathyofprematurity.org   January 2012      Total 11,297 words

 


My letter to President Obama to request a DoJ investigation

>>>  Unethical Bioethics Part 1   (4,159 words)
Medical suffocation experiment predictably killed 23 premature babies

Unethical Bioethics Part 2   (3,449 words)
The world’s longest-running involuntary euthanasia program  

Unethical Bioethics Part 3   (1,619 words)
Blinding babies by nursery light and by official obfuscation 

Unethical Bioethics Part 4   (2,528 words)
The Commission's “Moral Science” report contradicts its own conclusions 

 
 

My letter to President Obama to request a DoJ investigation

posted to the whitehouse.gov email form on January 30, 2012

 

Dear Mr. President:

 

The recent assurances from your Bioethics Commission about current safeguards for subjects of federally funded research are false. Both the universities led by its Chair and Vice Chair are among those involved in a series of knowingly lethal child suffocation experiments by oxygen withholding that recently killed 23 “extra” American premature babies to protect them from blindness. The experimenters committed these medical killings behind the backs of the parents. These were never told about this test which will also leave many of the surviving children brain damaged for life. You find this documented at http://retinopathyofprematurity.org/UnethicalBioethics1.htm

 

This series of fatal oxygen withholding tests led last year to new guidelines for American nursery doctors to give gasping preemies even less oxygen than the current routine. This will further increase the U.S. infant mortality rate and its 2010 rank as 34th in the world, behind Croatia and Cuba. The effect could resemble the death toll from the first two decades of oxygen withholding which medical estimates cite as 150,000  preemies, or 16 deaths for each case of blindness prevented. Other estimates are up to twice as high.

 

Withholding of “liberal” oxygen as “undeserved subsidy” was introduced in 1955, based on an eugenics-inspired research fraud that claimed it prevented baby-blinding from retinopathy of prematurity without increasing mortality. Its designers had instead asphyxiated the most vulnerable 13 percent of the babies before enrolling only the survivors. Oxygen had been given generously for many decades without causing any blindness.

 

The epidemic of baby-blinding started in 1940, the year after the introduction of fluorescent light. The same sequence repeated itself after the War in Europe and other countries as soon as these lamps became available there. The typical nursery lighting exposes the vulnerable retinae of a preemie in just a few minutes to eye-damaging levels of “blue-light-hazard”, as defined by industrial safety and laser guidelines. The National Eye Institute sponsored in the 1990s another research fraud to falsely deny this embarrassing role of the doctor-specified nursery lamps by patching the eyes even in the allegedly protected group much too late to prevent the damage.

 

Please ask your Department of Justice to investigate these past and present medical crimes, and have the Bioethics Commission retract its false assurances.

 

Thank you,

Peter Aleff

 

Part 1: Medical suffocation experiment predictably killed 23 premature babies


The ongoing series of NeOProM oxygen withholding experiments

 

The U.S. Presidential Commission for the Study of Bioethical Issues, a self-described “advisory panel of the nation’s leaders in medicine, science, ethics, religion, law, and engineering”, issued on December 15, 2011, its report “Moral Science: Protecting Participants in Human Subjects Research” about the current protections of human research subjects in federally funded scientific studies. Its conclusions asserted again what some of the Commission’s members had said all along even before they began their official review of this topic: current regulations and the requirement for voluntary informed consent generally appear to protect participants from avoidable harm or unethical treatment, and the Commission is confident that medical research abuses like those in the ‘ethically impossible’ subject-infecting syphilis experiments in Guatemala in the 1940s could not happen today.

 

However, the Commission offers no evidence to support these preconceived opinions dressed up as research results, its own report repeatedly contradicts them, and several well documented counter-examples clearly prove them wrong. To begin with these, both the universities led by the Chair and the Vice-Chair of that Commission are currently involved in an ongoing series of knowingly lethal medical child suffocation experiments that are even worse than what some now much denounced U.S. medical researchers did 65 years ago in Guatemala.

 

The modern asphyxiation experimenters intentionally withhold oxygen breathing help from premature babies to re-test again a half-century-old but vaguely defined, deeply flawed, and never confirmed medical speculation that reducing oxygen might prevent baby-blinding retinopathy of prematurity (ROP), although this withholding of the life-saving gas has long been known to reduce the incidence of the blinding mostly by killing the babies who would otherwise have grown up blind. Moreover, these researchers conduct their knowingly baby-harming experiments without the informed consent of the parents, and they blatantly violate the bedrock principles of medical and real ethics and patient protections as well as the U.S. criminal laws against willfully killing people.

 

The authors of that child suffocation protocol cite earlier medical estimates that the strict oxygen withholding policy introduced in 1955 had killed about 150,000 preemies in its first two decades, an often unacknowledged and still under-investigated uncontrolled medical mass slaughter that cost “16 deaths for every case of blindness prevented”. They claim that with improved methods for measuring arterial blood oxygen levels, “effects on mortality and long term sensori-neural outcome remain unknown and could be beneficial or harmful”.

 

However, the relevant clinical literature repeatedly reports higher mortality rates from lower oxygen saturation levels. The preponderance of evidence, confirmed again by the U.S. component of these experiments which recently killed 3.5 per cent “extra” babies in its low-oxygen group, shows clearly that this knowingly harmful practice continues to increase mortality and brain damage for preemies.

 

The latest attempt to reconfirm this baby-asphyxiation result from lower oxygen levels was conceived in 2003 by “an eminent international group of over 30 trialists, bio-statisticians, neonatologists, ophthalmologists, and developmental pediatricians” as a group of five parallel studies in Australia, Canada, New Zealand, the U.K., and the U.S.A.. Their goal was to increase the statistical power of the results by analyzing them together.

 

Four members of this group published the proposal for this multi-national oxygen withholding experiment in the May 28, 2003, issue of Pediatrics and gave there a hypothetical example to illustrate the trade-offs to be expected:

"Evidence of net benefit or harm from one outcome should be considered in the context of other major outcomes. For example, it would be inappropriate to terminate recruitment because of a 3 percent reduction in severe ROP in the lower oxygen group before the trial had accumulated sufficient power to exclude a 6 percent increase in mortality or severe neurodevelopmental impairment in the same group. In this case, if the trial were terminated prematurely and lower oxygen became the clinical standard, for every infant whose sight was saved, 2 would die or survive with major disability. “

(See page 1417 right, bottom, at http://pediatrics.aappublications.org/content/112/6/1415.full.pdf)  

A lay person may find it appalling that these experimenters aimed to exclude only a mortality-plus-major-disability rate that was twice the rate of blindness prevented, instead of requiring to rule out with confidence any added mortality or brain damage incurred merely to try and reduce a risk of blindness. Their willingness to accept that many deaths from their proposed oxygen withholding experiment reveals that they consider blindness a fate twice as bad as death or major disability.

 

Most blind people are likely to disagree with that lopsided judgment. Ask any blind person whether he or she would rather be dead or severely brain-damaged than blind, and they will overwhelmingly prefer blindness which many of them consider an inconvenience rather than a disability. Or make your own choice: would you rather live blind or be dead?

 

Yet, this “better-dead-than-blind” project got funded in five countries. The enrollment for the U.S. component started in 2005, and the last of its five studies is to be completed in 2014. Their series has the acronym NeOProM, and its ruthless suffocation protocol was published in BMC Pediatrics 2011,11:6. (See http://www.biomedcentral.com/content/pdf/1471-2431-11-6.pdf.)

 

One of the two U.S. collaborators in this ethically impossible modern medical research atrocity is the University of Pennsylvania, as listed at http://clinicaltrials.gov/ct2/show/NCT01124331?cond=%22Retinopathy+of+Prematurity%22&rank=33.

 

That university is a self-declared leader in bioethics and home of several prominent luminaries in that field, and its President is also the Chair of the Bioethics Commission which just assured us that such abuses are now impossible.

 

The NeOProM authors say that to determine the expected effects reliably for their “normal” and “low” oxygen groups, they need a sample size of over 5,000 preemies. In discussing the statistical reasons for exposing more than 2,500 newborn babies to the well known high risks of death and disability from low oxygen, they openly admit these risks to be created by their research. Although they reduce their “expected” death rate here to 4 percent, they show again that they understand the likelihood of sacrificing many among these babies to what should be called their “Immoral Science”:

“… none [of the five NeOProM experiments] 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 percent increase in death or serious neurosensory disability in survivors.”

Any competent reviewer of this potentially so disabling and predictably fatal project would have stopped it right there. The “expected valuable short term benefits” that to the NeOProM researchers justify killing many of their subjects were mostly of two kinds, one indeed short-term and the other permanent but not essential. One was a possible reduction in chronic lung disease which can give some preemies respiratory difficulties for up to their first year and may increase their later vulnerability to infections. This can be serious, but avoiding such a temporary and mostly non-fatal condition is certainly not worth risking anyone’s life.

 

The other and major expected benefit from oxygen withholding was a hoped-for decrease in the babies’ rate of blinding from ROP, as if non-fatal blindness was on the same level of risk as severe brain damage or death. The tradeoff proposes killing the baby to protect him or her from blindness, as if even intact eyes were of any use to a dead child, and it is clearly illegal.

 

Preemie research subjects tortured, maimed, and killed for science

 

Already the founding document of modern bioethics, the Nuremberg Code of 1947 created in response to the infamous Nazi doctors’ often lethal hypothermia, hypobaric, and other gruesome experiments on unwilling prisoners and other defenseless subjects, states clearly that 

“No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur” and “Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability, or death.”

Moreover, that Code and those declarations also state that the risk to any research subject should never be greater than the expected benefit to that same subject, and the Commission’s Chair re-affirmed recently this well-known bioethical principle by saying that “researchers [should] not inflict harms disproportionate to prospective benefits”. Killing a baby to protect him or her from blindness is certainly such a lopsided harm with no proportionate benefit, and that Chair’s university should not collaborate in inflicting this harm.    

 

The slow, painful, and often deadly asphyxiation imposed on gasping preemies in these hypoxemia experiments is a horrible torture. To get an idea how oxygen withholding might feel to a preemie, begin by comparing, for instance, the account of the adult Biosphere 2 volunteers how they became sluggish, weak, sore and depressed when the oxygen levels in their sealed enclosure dropped, and what profound relief they felt when they could breathe oxygen-enriched air, as quoted at http://retinopathyofprematurity.org/29futilityandharm.htm.

 

These volunteers went to their oxygen-rich “lung room” long before the lack of this gas was likely to cause them unbearable harm, but preemies deprived of this breathing help don’t have this escape option. The severity of their oxygen deficiency from insufficient supplements often causes them to suffer severe brain damage or death. Their pain while enduring this deprivation is likely to be much greater than that of the above volunteers, more in the range of the imminent suffocating sensation experienced by subjects of waterboarding which is hard to tolerate even for robust adults. Actually, the pain of the preemies is probably even worse because waterboarding is usually stopped before the victim suffers any permanent damage, but the preemies have to endure their protracted suffocation for hours or days on end without any relief, to the point that many of them incur life-long or even life-ending injuries.       

 

Yet, the NeOProM researchers cruelly expose vulnerable preemies to this merciless torture in their current Human Hypoxemia Experiments, still as insensitive to their fellow humans’ agonizing pain as American pediatric surgeons used to be when they routinely performed major surgeries on preemies without anesthesia. Yes, you read that right although you may find it unimaginable. Until quite recently, American doctors sliced and stabbed the vulnerable flesh of preemies without restraint or pain relief because they had been taught and blindly believed the obvious absurdity that preemies cannot feel pain.

 

This barbarian practice was official pediatric policy until late 1987 and was only changed after the mother of a preemie born in early 1985 found out that her son had been subjected to this indescribably dreadful torture. She then launched a campaign to shame the medical authorities into publishing a “new consensus protecting infants from unnecessary pain during surgery”. However, many surgeons stuck to their old beliefs and practices and continued to assert that preemies cannot feel pain. Her account of the medical resistance she encountered against the obvious is posted at http://retinopathyofprematurity.org/ROP_preemiepain.htm.     

 

Today’s nursery doctors display the same heartless lack of compassion when it comes to the preemies’ pain of slow suffocation. Slicing and stabbing in surgery cause pains that most people can relate to from the usually smaller scale of their own experience with knives and needles, but very few of us have first-hand knowledge of the chest-burning spasms caused by waterboarding or even longer bouts of asphyxiation. The pain caused by the withholding of oxygen from preemies may therefore be harder to imagine for most people, and even easier to dismiss by many empathy-challenged doctors, but this makes it no less real for the victims. There is no conceivable justification for nursery doctors to so casually inflict this unnecessary and harmful ordeal on anyone, least of all on the most vulnerable of all patients.   

 

In addition to so indifferently causing this horrible suffering and harm to their preemie subjects, the NeOProM suffocation researchers also expose them to deliberately increased risks of death and severe disabilities, all without any matching benefits expected for those unlucky victims of science. They inflict all this harm merely because of their research goal to maybe reduce some eye damage which would be laudable only if it did not increase the risk of their subjects’ death or severe brain damage. Still, in their distorted view this goal entitles them to treat these human babies as if they were disposable guinea pigs to be exploited at will. They clearly consider the lives and brain integrity of preemies less important than their own pitiless pursuit of grants and presumed knowledge, and of putting their names on resume-enhancing papers in prestigious professional journals.

 

The American SUPPORT preemie-killing test

 

The Nuremberg Code and later Declarations of Medical Ethics were mostly written to counter this long-standing academic arrogance of valuing the research and its alleged “greater good” above the welfare and even lives of its subjects. However, this conceit still survives unchecked among some medical researchers, and it recently killed 23 “extra” American preemies who died in the low-oxygen group of the U.S. component in that NeOProM series of suffocation experiments. This federally funded baby-asphyxiating experiment has the acronym “SUPPORT” and enrolled 1316 preemies from 2005 to 2009 in 16 participating hospitals.

 

The list of these hospitals includes the medical facilities of Emory University in Atlanta. The President of that university is also the Vice-Chair of the Bioethics Commission which just assured President Obama and the public that such willfully subject-harming medical wrongdoing could no longer happen today.

 

The preliminary SUPPORT results of 23 “extra” deaths from oxygen withholding were published in the May 27, 2010, online issue of the New England Journal of Medicine at http://www.nejm.org/doi/full/10.1056/NEJMoa0911781. Pages 1967 and 1968 of its PDF version list the participating hospitals, so if you had a preemie born there in those years you may want to inquire whether he or she was among the research subjects even if you were not told at the time about that ongoing experiment and its well known risks.  

 

The SUPPORT authors computed a four percent chance that the correlation between the 23 “extra” deaths and the oxygen withholding could be a fluke. This means a 96 percent probability that it was this brutal experiment that had predictably killed those 23 children as the first part of its collateral damage. The severe brain damage also expected among the same experiment’s survivors is scheduled to be reported separately.

 

Fictitious “informed consent” to medical atrocities

 

No parent informed about these known risks could legally have consented to letting their child be used as a means for such a painful and potentially injurious or even fatal experiment with no matching benefits. Such a needless sacrifice was definitely not in their child’s interest. Even without that legal constraint, no sane parents would willingly have accepted the well known but unwanted risks of letting their baby be agonizingly asphyxiated to death, or of having to devote the rest of their lives and resources to the often demanding and costly 24/7 care of a brain-damaged child while worrying how to ensure that care beyond their own lifespan.

 

Not surprisingly, the U.S. National Institutes of Health “cannot locate” the mandated but legally impossible “informed consent” forms for this deliberately harmful suffocation experiment which was necessarily conducted behind the parents’ backs. See http://retinopathyofprematurity.org/BioethicsConsent.htm for the absence of these phantom forms which either lied to the parents about the known risks or else were never shown to them.

 

If the parents were not specifically told about that hidden Human Hypoxemia Experiment, they had no means of knowing that it even existed and that their newborn child was enrolled in it. The designers of this double-blind experiment concealed their tinkering with any baby’s breathing help by adjusting the oxygen monitor displays to read three per cent either above or below the infant’s actual arterial saturation value. As a result, the readings for both high and low saturations oscillated equally around 90 per cent instead of the actual 87 and 93 per cent midpoints of the low and high ranges. Because of this masking, no one in the nursery could know which babies had their oxygen supply throttled.

 

Those designers had explained that their masking of the oximeters was essential “to minimize co-intervention and contamination by bias of neonatal care providers”. The term “co-intervention” appears to refer here to the tendency of nurses and parents to turn the oxygen faucet up when the number displayed was lower than what they had been told was the best value, or than the display for a baby in another incubator.   

 

The masking was also important for making this ethically impossible suffocation experiment possible at all. Its designers had already obliquely suggested in their initial 2003 proposal to skip the informed consent formality because this “defensive documentation” would be likely to reduce enrollment or make it impossible to begin with if its risks had to be explained to the parents. They offered this recommendation indirectly because it was clearly illegal, so they discussed “the wisdom of collecting only the relevant, necessary data” and then quoted approvingly this analysis from a 1998 article on the future of clinical trials: 

“Requirements for large amounts of defensive documentation imposed on trials by well intentioned guidelines . . . may, paradoxically, substantially reduce the reliability with which therapeutic questions are answered, if their indirect effect is to make randomized trials smaller or even to prevent them starting.” (See page 1418 left at http://pediatrics.aappublications.org/content/
112/6/1415.full.pdf.)

This passage clearly reveals the researchers’ intention to ignore the requirement for informed consent because only this “defensive documentation” imposed by “well intentioned guidelines” could have prevented many or all parents from volunteering their babies for that cruel experiment.

 

Most parents would likely have trusted their doctors to comply with their fiduciary duty to do what was best for their child. They would never have imagined that their baby could instead get his or her brain damaged or be killed from a deliberate lack of life-saving oxygen, withheld like the cure in Tuskegee, just to serve some heartless and clueless researchers’ scofflaw ambition. The doctors in the participating nurseries permanently injured or killed their child on the sly, without even telling them that they were abusing him or her, courtesy of the SUPPORT suffocators and their enablers for their dangerous and vain oxygen withholding experiment.

 

Those modern researchers’ open disdain for “well intentioned guidelines” and legal boundaries to medical investigation was common among US medical researchers around the middle of the last century, as distilled in this 1967 comment by Thomas Rivers, a famed virologist who headed the Rockefeller Institute for Medical Research Hospital in New York and wrote about medical experimentation on human subjects:

“… it's against the law to do many things, but the law winks when a reputable man wants to do a scientific experiment. For example, the criminal code of the City of New York holds that it is a felony to inject a person with infectious material. Well, I tested out live yellow fever vaccine right on my ward in the Rockefeller Hospital. It was no secret, and I assure you that the people in the New York City Department of Health knew it was being done....Unless the law winks occasionally, you have no progress in medicine.” (as quoted at http://scienceblogs.com/insolence/2010/10/the
_guatemala_syphilis_experiment_human.php

The current child suffocation experiments show that this contempt for the law as an inconvenient hindrance to medical experimentation survives in full force today.

 

Remedies for research wrongdoing

 

The Bioethics Commission states on page 63 of its “Moral Science” report that

“human subjects should not individually bear the costs of care required to treat harms resulting directly from that research” (page 6) and elaborates later:

“… once unethical research has come to light, the institutional sponsors of such unethical research bear some responsibility to make amends for past institutional wrongdoing or that of their former agents. As such, a formal apology, compensation for any identifiable living individuals harmed by such research, or symbolic gestures of contrition such as the establishment of charitable foundations or institutions related to the future prevention of such harms may also be appropriate in some cases.”

Although that Bioethics Commission suggests those amends only for past wrongdoing and former agents, there is no ethical reason why the same remedies should not also apply to current medical wrongdoing and present agents. It as well as all the other collaborators and participants in these child-abusing suffocation experiments should therefore apologize for the preemie killing and maiming which the universities of its leaders and many others committed and/or enabled. They should also compensate the victims harmed by their “ethically impossible” conduct and enable the affected parents to provide proper life-long care for their permanently injured children. Moreover, they should work towards the future prevention of such harms and of the ethics-disdaining medical researchers’ fact-immune mindsets that produce them.

 

The Commission should also prominently retract the dangerously misleading assurances about existing safeguards for research subjects it gave in its report. Before even looking at the other crucial flaws in that report, the NeOProM and SUPPORT counter-examples alone already prove those assurances wrong, just as a dead fly can spoil an entire jar of ointment, or a single black swan can destroy a long-held certitude so entrenched that one of the terms for a herd of swans is still “a whiteness”.

 

At least the scientists among the Commission members are not allowed the mental acrobatics of disregarding inconvenient but verifiable and unrefuted facts, or else they cannot maintain their claim to be scientists.

 

Medical ethics violations openly published and tolerated

 

Those 23 “extra” deaths in the SUPPORT suffocation experiment amount to 3.5 percent of the low-oxygen group, close to the four percent the NeOProM researchers had expected their test to kill or disable. The additional toll of severe disabilities from this grisly SUPPORT experiment was scheduled to be published in December, 2011, but seems to have been delayed. However, even this expected additional damage will not reflect the entire harm because some of the anticipated cognitive and neurological impairments caused by early oxygen deficits will become manifest only in later years. The researchers’ already shockingly high prediction of their unscrupulous experiment’s collateral damage may therefore still significantly underestimate the actual damage they inflicted on the hapless preemies in their low-oxygen group.

 

Those researchers’ open prediction of such harm to be caused by their experiment and its open reporting as their result highlights another major difference between their present patient-killing experiment in today’s U.S. and Dr. Cutler’s former patient-infecting syphilis transmission experiment in Guatemala 65 years ago, besides the escalation from his “merely” infecting his subjects to the current inflicting of severe brain damage and even death. Dr. Cutler and his enablers were well aware that they were transgressing the still mostly unwritten ethics rules of their time, so they kept their research project secret even though the formal Nuremberg Code that forbade such intentional harming was promulgated only towards the end of their work in Guatemala.

 

By contrast, the researchers and bioethics reviewers in the NeOProM and SUPPORT suffocation experiments, their grant approvers in five countries, the editors at the two or more prestigious medical journals that published their papers, and the Bioethics Commission that was repeatedly alerted to these transgressions but disregarded them -- all these seemed unconcerned that this knowingly patient-harming but openly described research is grossly violating the by now written rules of medical as well as real ethics and laws. The researchers may have kept their grotesque experimenting on helpless preemies hidden from the parents, but some of them described it openly in their medical journals, as if they never even realized the unethical and criminal aspects of the deaths and other injuries they had willfully inflicted.

 

A cynic might explain that even those among the experts who understand their criminal complicity in that preemie killing test know well that they have nothing to fear because there are no penalties for even such glaring misconduct. Official inquiries into post-Nazi medical research abuses are typically limited to examples from many decades ago, as the above proposal by the current Bioethics Commission to make amends for only past but not present wrongdoing illustrates again. Moreover, such inquiries never hold anyone accountable, except sometimes posthumously. Not one of the many U.S. doctors involved in the infamous Human Radiation Experiments of the 1940s to 1970s ever went to jail or was otherwise punished for having intentionally harmed so many unsuspecting people.

 

To the contrary, even over a decade after President Clinton had publicly apologized for Dr. Cutler's textbook-unethical patient-deceiving and cure-withholding Tuskegee Study, which that doctor had also directed in addition to his recently rediscovered patient-infecting in Guatemala, Dr. Cutler was still accorded high academic honors. This telltale treatment of a major ethics violator may give you a clue how the academic medical community really feels about such blatant research crimes, despite its members’ customary lip service to upholding the highest ethical standards.

 

And you will see in the next part of this series how similar offenses against ethics and laws became and remain standard medical practice in the treatment of defenseless preemies.

 

Continue here to Part 2:
The world’s longest-running involuntary euthanasia program
 

 

 

 
 

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