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   The 2010 study of withholding needed oxygen breathing help from preemies

 

was even more unethical than the syphilis studies in Guatemala and Tuskegee 

 
 


Open letter to Professor Amy Gutmann 
at info@bioethics.gov
University of Pennsylvania President and
Christopher H. Browne Distinguished Professor of Political Science and
Chair of the Presidential Commission for the Study of Bioethical Issues

from Peter Aleff, 2097 Cottonwood Drive, Vineland, NJ 08361,
prevent@retinopathyofprematurity.org
February 22, 2011

Dear Professor Gutmann,

Subject: Two US clinical studies more unethical and lethal than the syphilis studies in Guatemala and Tuskegee

Further to my email of November 27, 2010, about the patient-abusing and science-perverting LIGHT-ROP study of blinding premature babies conducted in the US from 1995 to 1998, I want to draw your attention to two other unethical studies, also of blinding premature babies in the US. The most recent of these patient-abusing trials severely reduced the usual oxygen breathing help for half of its subjects to try and reduce their blinding, despite the known increase in the babies' risk of death from this tight rationing of the life-saving gas. That study violated the Nuremberg Code, the Helsinki Declarations of Medical Ethics, the Belmont Report, and the US regulations for approvals by Institutional Review Boards, and it predictably killed 23 “extra” children with this attempt to protect their eyes from getting damaged, with a probability of 96 per cent that these deaths were related to the oxygen withholding.  

This misguided study was published last year. In addition to having treated its human subjects as disposable guinea pigs, it is likely to further encourage a current trend towards more severe withholding of this life-saving gas.  It will thereby unnecessarily kill even more preemies than the now common milder oxygen rationing routine already does, and it will also inflict severe brain damage on more of the survivors every day as you read this. This additional harm will continue until its baby-killing and brain-damaging tradeoff against mere blinding is publicly exposed and explicitly repudiated, so I will describe this study to you first.  It is part of a wider  trial with the acronym SUPPORT that was conducted in the US by the Support Study Group of the Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network.  This part of the SUPPORT study enrolled 1316 preemies from 2005 to 2009, and its preliminary results were published in the May 16, 2010, online issue of the New England Journal of Medicine under the title “Target Ranges of Oxygen Saturation in Extremely Preterm Infants” at http://www.nejm.org/doi/full/10.1056/NEJMoa0911781.

The SUPPORT study is one of five parallel studies around the world that are all based on the same knowingly baby-killing and -harming protocol of oxygen withholding to prevent retinopathy of prematurity (ROP). They were conceived in 2003 by “an eminent international group of over 30 trialists, bio-statisticians, neonatologists, ophthalmologists, and developmental pediatricians” with the goal to evaluate their results not only individually but also together in a pooled meta-analysis, called NeOProM, for greater statistical discerning power. The other four studies of this group are currently going on in Australia, New Zealand, England, and Canada. The Canadian study recruited subjects not only in its own country but also in the US, Argentina, Germany, Israel, and Finland. The NeOProM study is posted at http://www.biomedcentral.com/content/pdf/1471-2431-11-6.pdf [2].

Killing babies to save them from blindness   

The ethics-violating SUPPORT trial of withholding oxygen breathing help led to the predictable deaths of 23 American babies in an unsuccessful attempt to reduce the combined incidence of death and blinding among them. Blindness is a non-fatal condition and cannot justify the intentional increase in those babies’ risk of death. Nor does it make any sense to lump these very different conditions together as if they were of the same severity. This knowingly preemie-killing study should therefore never have been approved under current US and international rules for the conduct of medical research.

Yet, the researchers and their grant approvers tried to confirm and thereby validate the long-standing but hopelessly confused intensive care nursery practice of oxygen rationing which is based on the unsupported and unworkable theory of this breathing help causing the ROP damage to the preemies’ eyes. For a discussion of just how confused and unworkable that oxygen theory of ROP etiology really is, and for some of the damage it continues to cause, see retinopathyofprematurity.org/29futilityandharm.htm

As these researchers well know, oxygen is a life-saving gas that helps many preemies to survive, including the most vulnerable ones who are at the greatest risk for the eye damage. Rationing the oxygen is known to significantly increase the mortality among the preemies who need it, so any therapy based on such a withholding of needed treatment is worse for the patient than the ailment to be prevented, and it can therefore not be ethically used.

The SUPPORT study authors know about the mass carnage of preemies in the wake of the oxygen-condemning studies from the 1950s. The final report for the largest of these was published in 1956, and as was to be expected, reducing the oxygen breathing help drastically reduced the incidence of blindness.

Unfortunately, this reduction was only achieved by asphyxiating most of those babies who would otherwise have lived to be counted as blind. To emphasize this lethal result, the SUPPORT authors cite a British report from 1973 that the oxygen withholding practices this study had formally introduced 17 years earlier had by then led to an estimated 16 deaths for each case of blindness prevented[3]. The NeOProM authors also mention an estimate of 150,000 preemies killed from lack of oxygen in the first 20 years after the largest of these studies and its fatal recommendation to withhold the life-saving gas[4].

However, the SUPPORT authors argued that since those times of mass-infanticide by oxygen deprivation, measurement techniques for oxygenation levels had improved. The latest of these, called pulse oximetry, allowed clinicians to continuously monitor the oxygen saturation and to target these levels in a defined range.  They did not say whether they expected these more accurate measurement techniques to result in better survival rates, but they expressed the hope that lower target levels of oxygen saturation would lead to a lower incidence of ROP. They summarized a limited sample of studies with that result for most of which the mortality had not been reported, but in at least one it had risen by 8 to 11 per cent depending on the birth weight group[5], and they admitted the risk:

“Although data from these studies suggest that maintenance of oxygenation at ranges lower than those previously used may decrease the incidence of retinopathy of prematurity, the safety of low target levels of oxygen saturation remains a concern.”

Still, these disclosed concerns about the safety of their trial to the lives of the enrolled babies did not stop them from inflicting their dangerous oxygen-rationing protocol on the children entrusted to them. They ignored their guild's traditional motto of "first do no harm" and thereby predictably killed 23 human babies with their suffocation research. Then they announced their improvement over the earlier cited 16 deaths per case of blindness prevented:

“Our data suggest that there is one additional death for approximately every two cases of severe retinopathy that are prevented.”

Since death and blindness have greatly different values, particularly to those directly affected, the SUPPORT researchers’ deal changes from the equivalent of paying 16 dollars to save one penny to keeping two pennies for paying only one dollar bill.  This may be an improvement, but it remains an unacceptably bad trade, and none of the SUPPORT and other NeOProM researchers have any right to strike such a lopsided deal on behalf of anyone in their care, nor do any parents have a right to knowingly volunteer their baby for such a risk.

However, many of the headlines following the release of the SUPPORT results were of the type “UAB Study shows Lowering Oxygen Level for Preemies Lessens Severe Eye Damage” where you had to read the article itself to find out that this touted prevention of ROP also “increased the chance a neonate would die before discharge”. Moreover, that article’s conclusion, by one of the participating neonatologists, left it up to the individual doctors how much weight to assign to each of those different outcomes, as if the current rules and regulations were not unanimously clear about not risking death to prevent a lesser problem:

“Health care providers should try to prevent both too high and too low levels of oxygen saturation to optimize survival without retinopathy”[6].

Even more misleading, the headline about an apparently separate but similar study from a press release by the maker of one pulse oximetry equipment brand read:

New Multi-Center Study Finds Clinical Practice Change with Masimo SET Pulse Oximetry Reduces Severe Eye Damage More Than 50% in Premature Newborns”[7].

This promotional article did not mention any deaths associated with the oxygen rationing maintained by means of this equipment, as if reducing blindness was self-evident justification for whatever other effects this intervention may have caused.

The SUPPORT study is worse than the Guatemala syphilis study

As to the ethical aspects of the SUPPORT study, its practice of intentionally exposing study participants to a greatly increased risk of death created by the study is even worse than the intentional infecting of unsuspecting study subjects some 60 years ago, in the infamous study of syphilis in Guatemala which President Obama called “clearly unethical” and asked you to also investigate.

The unsuspecting study subjects in Guatemala were intentionally infected but then were at least treated with penicillin, the most promising then available treatment against their infections, since the aim of that deceptive study was to evaluate whether this antibiotic was a useful treatment. According to the reports, at least one of the so infected patients died during the experiments, but it is not clear whether the death was from the tests or from an underlying condition.

By contrast, 23 premature babies in the very recent SUPPORT study on US soil were simply left to die and many more to suffer permanent brain damage from their intentionally induced oxygen deprivation. Preemies cannot tell us how they feel, but if you want to get an idea how horrible and debilitating such oxygen deprivation feels to adults, see the last third of the page http://retinopathyofprematurity.org/29futilityandharm.htm.  

Since preemies are even more sensitive to any injury than adults, their suffering is likely even more intense, even though nursery doctors have long maintained that babies cannot feel pain. This blatant absurdity was part of their doctrine to the point that they routinely performed major surgery on preemies without any anesthesia until a clear-thinking and no-nonsense mother found out in 1985 and triggered a widespread public outrage that shamed the reluctant doctors into stopping this barbarian torture. See retinopathyofprematurity.org/ROP_Preemiepain.htm for that courageous mother’s account of her battle against her son’s doctors’ casual cruelty.

The oxygen-starved babies in the SUPPORT study probably also gasped in desperate pain much worse than that inflicted in the infamous syphilis studies, but they received no relief from their oxygen starvation nor any treatment against it because the aim of this even more callous study was to evaluate how many of them would die or go blind from either mild or severe withholding of the best then possible oxygenation treatment. The researchers then computed a 96 per cent probability that these 23 “extra” deaths in their “severe withholding” group were not due to mere chance.

Another difference is that the US researchers in the 1946 to 1948 Guatemala syphilis study were aware that their deceptions would not pass any ethics smell test or meet the Nuremberg Code. That Code was first presented in July, 1947, but even then its contents was not really new, it only reflected the then prevailing official positions on medical ethics in the US. The first third of that one-page Code is devoted to the importance of informed consent which was totally lacking in Guatemala, and it also forbids some of the other practices from that deceptive research. The US researchers in Guatemala tried therefore to keep their work secret.

The researchers and grant approvers in the SUPPORT study, however, openly and knowingly risked the lives of their patients 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 knew that this Code stated in Articles 5 and 7 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.”

The 2008 Helsinki Declaration of Medical Ethics imposes similar duties on the physician to promote and safeguard the health of patients, including those who are involved in medical research, and it summarizes these in its Article 6:

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

Similarly, the US “Criteria for IRB approval of medical research” list in paragraph 46.111 the requirements a research project must meet for approval by these Institutional Review Boards, such as:

“Risks to subjects are minimized.” (…) “The IRB …. should be particularly cognizant of the special problems involving vulnerable populations, such as children …” (…) “When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, …, additional safeguards have been included in the study to protect the rights and welfare of these subjects.”

All these rules and regulations were well known to the SUPPORT authors and approvers, but they behaved as if they were sovereign and not subject to any of the limitations that specifically forbid such lopsided risk-taking with the lives of any study subjects, and particularly with the lives of vulnerable children.

The NeOProM summary of its oxygen-withholding trials openly ignores these clear and mandatory rules for patient protection “against even remote possibilities of injury, disability, or death” and declares that

“… 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.”[8]

In other words, the SUPPORT researchers knew beforehand that their trial design could cause 4 per cent extra deaths just for the expected benefit of maybe protecting some of them from blindness, and that the risks to their subjects were therefore neither minimized nor outweighed by the potential benefits.  In open defiance of all applicable regulations, they proceeded anyway with their trial. They thereby killed preventably an extra 3.7 per cent of the children in their “low-oxygen” group, with a probability of only 4% that this difference might be due to chance. This result was close to the NeOProM prediction of 4 per cent, but that prediction is no excuse for so treating the human children in their care as disposable and OK to sacrifice for their research.

The supposedly patient-protecting Institutional Review Boards found nothing wrong with the baby-killing and oxygen-starving described by the study authors.  Neither did the members of the Data and Safety Monitoring Committee which the director of the National Institute of Child Health and Human Development had appointed for this study. This Committee

“reviewed the primary outcomes, adverse events, and other interim results at approximately 25%, 50%, and 75% of planned enrollment”,

but it failed to intervene when the deaths in the low-oxygen group accumulated to exceed those in the better oxygenated group.  This accumulation did surely not occur all at once only at the end of the trial, but the Committee appears to have been slow in detecting this increased death rate only then. Three of the SUPPORT study’s lead authors wrote in reply to a reader’s letter in the 9/23/2010 online issue of the NEJM:

“Once we observed the increase in mortality in the group receiving reduced oxygenation at the end of our trial, we shared the data (in confidence) with the data monitoring committees of the ongoing trials.”

To an outsider with the naďve belief that a doctor’s job is above all to minimize harm to patients, it may seem strange that the SUPPORT authors would have communicated their extra death toll only “in confidence” to the monitors of the parallel NeOProM trials, instead of openly alerting everyone involved about the increased risk to the babies in the low-oxygen group. Their treating these deaths in such a casual and low-key way confirms again that they were not at all surprised by that outcome but had already predicted it long beforehand.

The only time this Committee put the trial on a temporary hold was when 247 infants had been enrolled. At that time, it expressed concern that readings of actual oxygen saturation levels often exceeded the target levels. The reason for this turned out to be that the babies who did not require supplemental oxygen accounted for a large proportion of the high saturation levels. To solve this statistical problem, the data of those normally breathing babies got reported separately to that Committee, and the enrollment resumed. Unfortunately, the SUPPORT authors did not report the data on those normally breathing babies also separately to their readers who could then have compared that group to the supposedly “high oxygen” babies and the relative rates of adverse outcomes from slight rationing versus freely breathing.

This incident highlights the fact that babies who breathe room air on their own have more oxygen in their blood than most of those who received oxygen supplementation. Even those in the so-called “high-oxygen-target” group were held back from achieving the naturally higher oxygenation levels of their normally breathing isolette neighbors. It is therefore likely that some of the “normal” deaths in even that group may also have been due to oxygen deprivation, and that the total number of deaths caused by the researchers’ oxygen rationing may have been higher than the 23 admitted in their paper.

To an outsider not misled by unctuous talk about “medical ethics” or about the purportedly eminent reputation of the so-called experts involved, this mockery of the most basic patient-protection rules makes the extra 23 or more babies killed in the SUPPORT trial the defenseless victims of pitilessly premeditated medical mass murder.

When Saddam Hussein’s Iraqi army invaded Kuwait in 1991, reports about its soldiers having ripped 22 Kuwaiti preemies from their incubators and left to die so inflamed the US public that the vivid accounts of this atrocity were said to have swayed the war-deciding vote for Gulf War 1 in the US Congress, even though those preemies later turned out to have been fictitious[9]. And if a hypothetical serial strangler on a rampage in a nursery strangled the necks of many babies and 23 of them died, he would be arrested and punished for this crime.

On the other hand, when the SUPPORT researchers throttle the oxygen faucets of many real babies and 23 of them die, they get a career boost from publishing a paper in a prestigious journal about their systematically planned killing spree.

As the unethical syphilis studies in Guatemala and Tuskegee and the equally infamous “Human Radiation Experiments” showed, this open disdain for legal boundaries to medical investigation was common among US medical researchers around the middle of the last century. Their contempt for the law was aptly highlighted in this mid-century comment by Thomas Rivers, a famed virologist who headed the Rockefeller Institute for Medical Research Hospital in New York and said shortly before his death in 1962 about medical experimentation on human subjects:

“Unless the law winks occasionally, you have no progress in medicine.”[10]

The SUPPORT study demonstrates that this same above-the-law attitude persists today, and that the regulations for alleged patient protection are still no more than just window dressing meant to hide what happens behind that  facade.

Misinformed Parental Consent

I requested on January 10 from the National Eye Institute at the National Institutes of Health under the Freedom of Information Act copies of the “Informed Consent” Forms for the SUPPORT study used by each of the participating hospitals and some other related documents. After some email and phone discussions with a FOIA Analyst at the Eunice Kennedy Shriver National Institute of Child Health and Development/NIH about the scope of my inquiry, we reduced the number of documents involved, and I emailed my agreement to the so reduced request on January 18.

The FOIA law obliges the government agency in charge of the requested records to release these to me within twenty working days, but as of February 22, I have not received any of the requested material.

When I receive these Forms, I will post a representative sampling of them at retinopathyofprematurity.org/BioethicsConsent.htm.

Update on February 23, 2011:

The Freedom of Information Coordinator at NICHD/OSPAC-PICB informed me in a letter I received today:

"The NICHD Neonatal Research Network Pregnancy and Perinatology Branch searched its files and no records regarding Informed Consent Forms or additional NICHD funded grants related to oxygen saturation in preterm infants were located."

Informed Consent is required by law and regulation for any medical study involving human subjects. I plan to appeal this determination that there are no records of this consent since they are mandated to exist, but the refusal to release them raises the strong suspicion that the National Institutes of Health may be trying to cover up that the researchers apparently skipped this problematic step.

It would have been very easy to hide from the parents that the researchers were experimenting with the oxygen breathing help for their baby because the oxygen measuring instruments were electronically altered to display the same range of values for both the normal and the low-oxygen group so that the nursery staff remained unaware of which baby was in which group. This kind of assignment masking is common in clinical studies to prevent potential bias for or against a particular group. In the case at hand, it also kept the parents in the dark not only about the group assignment of their child but even about the fact that he or she was enrolled in any study at all, unless someone informed them about that study to obtain their consent. And this consent would surely have been hard to obtain from any parents for increasing their child's risk of death.

Indeed, it is clear that if the mandated but missing Informed Consent Forms existed, then they did either not fully explain the increased risk of death for the babies so that the misled parents or guardians would have been able to sign them in good conscience, or else the Forms described that risk honestly. In that latter case, the Consent would not have been valid because no parent or guardian is legally allowed to make decisions for their child or ward that are not in the best interest of said child or ward.

This principle was asserted for parents, for instance, in an October, 2001, Opinion on Motion for Reconsideration by the Court of Appeals of Maryland:

“a parent cannot consent to the participation of a child . . . in nontherapeutic research or studies in which there is any risk of injury or damage to the health of the subject.” As we think is clear from Section VI of the Opinion, by “any risk,” we meant any articulable risk beyond the minimal kind of risk that is inherent in any endeavor. The context of the statement was a non-therapeutic study that promises no medical benefit to the child whatever, so that any balance between risk and benefit is necessarily negative.“[11]

The same limitation to the rights of guardians in volunteering their ward for risky research is included in the IRB approval rules paragraph 46.409 (b) on wards. Increasing a baby’s risk of death with no matching or greater benefit to that baby is obviously not in that child’s interest, and no parent or guardian can legally gamble their child’s or ward’s life for a comparatively minor potential benefit such as a chance of preventing blindness.

It is revealing to note that the researchers claim to have obtained the parent's or guardian's consent for each child before delivery so that the preemies in this SUPPORT trial were all enrolled by the time they were two hours old.

By contrast, the LIGHT-ROP researchers as well as Dr. Kupfer, then the head of the National Eye Institute, had explained the crucial and indefensible delay of up to 24 hours before the eye-patching of their allegedly protected preemie group with the knowingly false pretext that before the birth "the doctor's goal is to stop the contractions and prevent a premature birth; there is little, if any, time to ask the mother or father for consent to a study". And after birth, Dr. Kupfer explained, "it would not be ethical to approach the mother for consent until she is physically and psychologically able to provide it, The mother is not only under the effect of sedation but also mental exertion, and she is unable immediately to understand what is being proposed." These were the reasons given why the parental consent for enrollment in the LIGHT-ROP study could allegedly not be obtained sooner[12].

This blatant lie was plainly meant to help cover up the intentional fraud in that rigged LIGHT-ROP study. Such dishonesty from supposedly scientific doctors leads inevitably to the public’s justified distrust of anything that medical officials and researchers say, regardless how highly they rank in their academic or governmental hierarchies, or how many studies they claim to prove their point. Just as a single fly is said to spoil an entire jar of ointment, one such lie taints them all.

 

Most blind people prefer living blind to getting killed

The designers of this recent SUPPORT study deliberately increased the harm they inflicted on half the enrolled children to the point where they knowingly caused avoidable human deaths in an attempt to prevent mere blindness. In addition to the 23 or more children killed by the throttling of the life-saving gas, a so far unknown but likely high incidence and severity of permanent brain damage is to be expected from the oxygen deprivation among the survivors. This additional harm will be evaluated only up to the survivors’ corrected ages of 18 and 24 months, until April, 2011, and this short-term follow-up examination is planned to be published in December, 2011. No long-term examination of further late-onset harm caused by this hit-and-run study is planned although delayed retinal detachment and other eye damage from ROP progressing over decades are common, and many forms of brain damage become noticeable only at school age or in even later years.

The federally supported researchers in this 2005 to 2009 SUPPORT study inflicted all those deaths and other severe harm merely to test a hoped-for though predictably unworkable method of maybe reducing the development of blindness. Blindness is a non-fatal condition which many of its well adapted victims, such as those at the National Federation of the Blind, describe as an annoying inconvenience or nuisance rather than as an incapacitating disability that would keep them from leading full and independent lives[13]

For instance, the current President of that Federation, Dr. Marc Maurer, worked for some time as an automobile engine repairman to show to himself and others that he could master such a complex manual skill. He then earned a law degree  and became a successful attorney as well as an untiring activist for improving the public’s perception of blindness[14]. If he had been born just a few years later, the then introduced oxygen withholding policy would probably have killed him right away, together with the many tens of thousands of other cruelly asphyxiated preemies, or else it would have irreparably damaged his brain to make him unable of such accomplishments.

Confirming this benign image of blindness as by far preferable to death, my Google alerts for online mentions of “retinopathy of prematurity” frequently provide links to stories about people blinded by ROP who excelled in some sport or musical event at school and proudly display their awards, or who describe how their lack of sight does not really handicap them. A typical example of the latter is a newspaper article of January 16, 2011, where a broadly smiling and contagiously happy-looking young lady with a “positive, sunny personality” and with blindness explains:

”Most people who are born prematurely have very debilitating disabilities. Some can’t walk or feed themselves. Some don’t even survive,” she said. “[By comparison,] I consider blindness to be a good thing. I can do virtually anything anyone else can do, I just have a different way of approaching it.”

Frederick said her biggest challenge isn’t a physical one, but a mental one - dealing with people who don’t quite know how to handle her.

"There are a lot of misconceptions out there about me. People will talk louder, thinking I can’t hear, or they’ll talk down to me, but I’m just a person who happens to be blind. This is who Katie Frederick is. I’m as independent as possible, but I have an eye condition,” she said. “I do have my down days every once in a while. But, even on my down days, I really try to stop and think, ‘You don’t really have much to complain about. You can’t see, but you can walk and talk, and I try to be grateful every day.”[15]

This universal preference for living with blindness instead of being dead is nothing new. Although the ancient Greek playwright Sophocles had his Chorus Thebans tell their mythical king Oedipus that he would be “better dead than living blind”, the florishing of blind bards such as Homer as well as ancient Egyptian paintings of blind harpists show that those fictitious Thebans merely used dramatic rhetoric and did not reflect reality. More realistically, the non-mythical Plato set the record straight and wrote

“… every soul possesses an organ better worth saving than a thousand eyes because it is our only means of seeing the truth …”[16].

The “organ for truth-seeing” was for Plato our mathematical ability. To illustrate his point with just two of many modern examples, the 18th-century master mathematician Leonard Euler became totally blind in his late fifties but then even increased his already unmatched output of major discoveries during his remaining seventeen years, dictating abstract mathematical papers as fluently as others converse[17]. Another such sightless truth-seer was Emma A. Coolidge, a blind woman from 19th-century Massachusetts, who contributed one of the more creative entries in the crowded field of proofs for the so-called Pythagorean theorem[18].  The ability of many blind people to excel in mathematics even led to the development of a special tactile notation for mathematical expressions and formulae, the Nemeth Braille Code for Mathematics[19]

Like all babies with or without sight, any of the 23 children so casually killed in this latest oxygen-rationing study had the potential to achieve comparable eminence in this or other fields, or to happily live their normal lives even without any extraordinary gifts. Yet, the SUPPORT researchers willfully ended those lives before they even had a chance to unfold, just to try and protect them from the risk of blindness with an unproven and unworkable theory.

This anti-blind way of thinking was once actively promoted by the pseudo-scientific but medically influential eugenics movement, as described in detail at http://retinopathyofprematurity.org/20oxygeneugenics.htm and on the pages that follow it. For some current examples of this attitude which has been long discredited among the general public but which appears to survive among many doctors who absorbed it as part of their medical studies, see the second half of http://retinopathyofprematurity.org/23oxygenstudyfrauds.htm .

The researchers’ confusion about relative severities of risk 

The SUPPORT researchers appear to ignore or deliberately dismiss the major difference between death and survival with blindness. The goal of their study, as stated on its page 2, was to

“… test the hypothesis that a lower target range of oxygen saturation (85 to 89%), as compared with a higher target range (91 to 95%), would reduce the incidence of the composite outcome of severe retinopathy of prematurity or death among infants who were born between 24 weeks 0 days of gestation and 27 weeks 6 days of gestation”.  They add two pages later that “An absolute between-group difference of 10 percentage points in the rate of the composite primary outcome was considered clinically important”.

This lumping together of blindness and death into one “composite” implies that the researchers consider each of these outcomes equally adverse. Otherwise, it would not make any sense to add items of greatly different values to then consider only their composite total. Blindness inflicts a much lower level of harm than death, so their misguided lumping logic is like counting three dollar bills and seven penny coins as a total of ten currency items, and to then accept any combination of nine such items as a ten-percent reduction, even if the so “reduced” total consists of eight dollars and one penny.

Those willfully ignorant and careless researchers’ failure to distinguish between the levels of risk to their trial subjects violates all the relevant codes of medical ethics as well as the US regulations which are based on them. Already the founding document of modern medical ethics, the Nuremberg Code of 1947, states clearly in its Article 6 that

“The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment.”

Following this model, all the World Medical Association’s successive Declarations of Helsinki about medical ethics include the same principle, quoted here in its latest version as Article 21 from 2008:

“Medical research involving human subjects may only be conducted if the importance of the objective outweighs the inherent risks and burdens to the research subjects.”

The US regulations for the approval of medical research by Institutional Review Boards concur in their paragraph 46.111(a)(2) that medical experiments should only be approved when

“… risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result”. 

Risking your life to save your eyes is certainly not reasonable by any standard since even intact eyes will be of no use to a dead person. Conversely, most blind people clearly prefer living without sight to getting killed so that they don’t have to live with that loss.

The high cost of misleading research

Like the deceptive LIGHT-ROP study, this oxygen-rationing SUPPORT study helps not only to prolong the routine asphyxiating and brain-damaging of preemies but also to continue the current epidemic of light-induced baby-blinding from ROP among the survivors. In most developed and middle-income countries, ROP is said to either blind more children than all other causes combined, or else to be the second most prevalent cause of childhood blindness.  No one really knows the actual numbers because there is no organized system for keeping track of the cases. However, the World Health Organization has also identified ROP as a leading cause of vision impairment among children in the developing world[20].

In the US, ROP costs the federal and state governments billions of dollars per year for elaborate eye examinations and retinal surgeries, for special education and services to the blind, and for steadily added obligations to make life-long disability payments not only to the several hundred to several thousand children per year whose eyes are damaged by the nursery lights but also to the many more who suffer permanent brain damage from the unnecessary and unjustified oxygen deprivation.

The National Federation of the Blind estimates the prevalence of legally blind persons in the US at 1.3 million of which 93,600 were in 2002 blind school age children.  If ROP indeed accounted for the majority of blindness cases among US children, as has often been asserted, then the number of its living US victims at that time would have been about 47,000 children, without counting the adults whom ROP  had blinded earlier. This incomplete guesstimate puts ROP at about 3.6 per cent of that total prevalence, but its impact is further increased by the much higher number of disability-years among babies blinded for their entire lifetimes[21] and not just for the fewer waning years which usually make up less than one sixth of a lifetime, as in age-related macular degeneration or similar late-onset causes of blindness.

According to the study, “Economic Impact of Vision Problems: The Toll of Major Adult Eye Disorders, Visual Impairment, and Blindness on the U.S. Economy” by Prevent Blindness America, last updated in 2008, the costs of adult vision problems to the U.S. economy amounted then to $51.4 billion per year[22]. To get an idea about the order of magnitude attributable to ROP, 3.6 per cent of this partial adults-only total is almost two billion dollars per year for just some of the ROP-caused blindness, and without adjusting its cost for its much larger number of disability-years.  This guess does also not include the probably even much larger cost of the brain damage caused by its wrongly attempted and ineffective prevention by oxygen withholding.

For comparison, and again counting just the blindness alone, an Australian study estimated in 2006 that the absolute economic burden of visual impairment on the entire Australian economy amounted to about 0.6 per cent of that country’s GDP and ranked on the same cost level as cancer, dementia, and arthritis, but ahead of coronary heart disease, diabetes, depression, and stroke[23][24].  As in the US, blindness from ROP accounts in Australia for only a small part of this total, but also certainly a non-trivial one.


The SUPPORT trial studied the wrong suspect

All these costs could be easily avoided by eliminating ROP with a simple change of light bulbs in the preemie nurseries. However, poorly conceived studies such as the baby-killing SUPPORT trial continue to distract people from this obvious but doctor-embarrassing solution, and they help to unnecessarily prolong this costly epidemic.

The effort of the SUPPORT study to again try and refine the often asserted but never proven link of the life-saving oxygen to the blinding, after more than half a century of questionable studies and admitted mass killings of premature babies from oxygen withholding, is both misguided and misleading. It is misguided because it stubbornly investigates the wrong suspect which the above-cited rigged LIGHT-ROP study had attempted to falsely exonerate, and it is misleading because it diverts the attention of parents and nursery doctors from the real and never honestly refuted cause of the blinding which is clearly the excessive irradiation of the preemies’ still developing retinae with fluorescent nursery light.

Animal experiments have shown that high oxygen levels can enhance retinal light damage but they cannot trigger it. Moreover, this breathing help had been administered routinely to preemies for almost half a century before the introduction of fluorescent lamps and, less than two years after that, the beginning of the ROP epidemic. But instead of acknowledging these undeniable facts, the SUPPORT team endangers hundreds of helpless babies with their mistaken and imprudent but stubborn oxygen rationing and obstinately kills 23 of them.

The 2008 Helsinki Declaration of Medical Ethics states clearly in its Article 12 that

“Medical research involving human subjects must conform to generally accepted scientific principles, be based on a thorough knowledge of the scientific literature, other relevant sources of information, and adequate laboratory and, as appropriate, animal experimentation.”

The SUPPORT researchers who so tenaciously pursue the dead-end oxygen theory willfully ignore and/or dismiss a vast literature on light damage to the eye which was developed with many systematic animal experiments and evaluations of accidental human overexposures. This large body of knowledge was produced mostly for Occupational Safety purposes of protecting industrial workers, but its results apply equally to the exposure of all mammalian retinae, including those of human preemies.

Even directly in the medical literature itself, bright red flags were raised about the role of light in baby-blinding. For instance, in August 1970, a team of physicians from Boston and Philadelphia described in their paper “Retinal Changes produced by Phototherapy” how they had placed newborn piglets under bilirubin phototherapy lamps with a total irradiance of 300 ftc “to determine if retinal damage does in fact occur during phototherapy of the newborn infant”.  They did find major retinal damage from short exposures and warned about the almost as strong standard fluorescent nursery lighting which the American Academy of Pediatrics specified at that time to shine at 100 ftc:

“The intensities of light used for illumination in nurseries may need to be evaluated for their short- and long-term detrimental effect on vision in the newborn infant.”[25].  

Moreover, in late 1982, the child psychologist Dr. Penny Glass and her co-authors covered the top and back of each preemie isolette in two Washington, D.C., nurseries with permanently mounted gray filters.  Then they reported in August, 1985, in the New England Journal of Medicine that so reducing the light on the baby from 60 ftc to 25 ftc had greatly reduced the number of ROP victims in both their nurseries. In their highest-risk group, the preemies with birth weights below 1000 grams, the ROP rate had decreased from 86% before the filters to 54% after this partial light reduction.  

The results of Glass’ team were the most dramatic reduction in both incidence and severity that any of the non-rigged approaches to ROP had ever shown.  For the above highest-risk group of babies, there was only one chance in a hundred that the reduction in eye damage might be a random coincidence and had nothing to do with the light reduction.  For all the babies in all the groups together, that chance was given as almost one in twenty[26].  Yet, these alarming results did not move many nursery doctors to change their blinding nursery lamps.

For a more detailed discussion of these experiments on piglets and on shaded preemies, see retinopathyofprematurity.org/37studiesoflightandROP.htm. 

To ignore this clear evidence against the nursery lighting even in such supposedly familiar sources as the Journal of Pediatrics and the New England Journal of Medicine goes beyond gross neglect of the due-diligence duty the researchers owe to the trial subjects under their control. Also, the SUPPORT researchers are not conforming with the generally accepted scientific principle that requires them to be familiar with the relevant scientific literature and other sources of information.

These other sources include the common knowledge that thermal light damage from unprotected staring at the sun or at a welding arc can accumulate to dangerous levels in mere seconds, and that the photochemical damage from less intensive exposures for just a few minutes can inflict comparable harm, just as the photochemical exposure of photographic film is a function of both intensity and duration.

The SUPPORT researchers also blatantly ignore the detailed documentation of OSHA light damage researchers that the radiation spike at 435.8 nanometer wavelength, which is common to virtually all fluorescent tubes like those specified for intensive care nurseries, is precisely in the middle of the narrow region of maximum light damage to the retina[27]. They further remain unaware of the easily computed fact that the typical fluorescent intensive care nursery lighting exposes the unprotected and still developing and therefore extremely vulnerable retinae of the preemies in less than 15 minutes to more damage-weighted retinal irradiance than the Occupational Safety Guidelines allow as the danger limit for robust adult workers over an eight-hour work shift.

The problem is not that this information is inaccessible. Every medical library has shelves full of articles on light damage to the eye. Furthermore, over the past two decades, I have sent copies of my 1991 Iatrogenics paper “Baby-blinding retinopathy of prematurity and intensive care nursery lighting”[28] with excerpts from this information and its detailed documentation to the American Academy of Pediatrics, to the American Medical Association, to the National Eye Institute, to the Office for the Protection from Research Risks, to the Office of Research Integrity, to your predecessors at the National Bioethics Advisory Commission appointed by President Clinton, to the LIGHT-ROP researchers, as well as to many hospitals, neonatologists, ophthalmologists, and other doctors, to many organizations with “prevention of blindness” in their mastheads or mission statements, and to the major manufacturers of fluorescent lamps.  I sent the detailed information to all these and many more but without ever receiving any sentient response, except for occasional form letters acknowledging the receipt of my mailing.

None of all these alleged experts have ever shown the slightest interest in helping their country’s preemies by following the scientific evidence instead of their self-serving and guild-protecting prejudices. And no one has ever refuted any of the evidence against the nursery lamps which is widely available and which I documented for them. Yet, simply ignoring such alerts does not make the facts go away or diminish the legally mandated but openly disobeyed duty of medical researchers to be aware of them, regardless how fossilized or eugenics-tainted their personal opinions may be.
 

The SUPPORT trial designers willfully closed their eyes to all this widely available information, including the easily verified fact that the eye damage to preemies started in 1940, right after the introduction of fluorescent lamps in the US, and in other developed countries only after World War 2 when those lamps also became available there. By contrast, the newly maligned oxygen breathing help had previously been administered for many decades without ever causing a single case of ROP.

Disregarding or snubbing such basic and undeniable facts relevant to the core of their risky experiment on babies entrusted to them does not exonerate the researchers responsible for such glaring omissions in their legally required due diligence. No matter how “eminent” they may be in their colleagues’ eyes or in their own self-esteem, they prove themselves to be scandalously incompetent for ignoring a vast body of scientific knowledge directly related to the problem they pretend to study. They are also inexcusably negligent for not even heeding the clear warnings against the nursery lights in their own medical literature. And they are criminally unethical for recklessly sacrificing 23 human lives to their willfully arrogant ignorance.


Why was the knowingly baby-killing SUPPORT trial ever approved?

In a 2001 editorial titled “Tuskegee: Could it happen again?”, Professor Susan M. Reverby, the Wellesley health care historian who re-discovered in 2010 the existence of the 1946 to 1948 US syphilis study in Guatemala, had warned that

“Moral statements from international medical bodies, overworked governmental regulators, and quickie courses on ethics in our health science schools and for continuing education credit may no longer be enough to protect us from the modern-day equivalents of what happened in Tuskegee. (…) We need serious sanctions against those who violate these new rules and principles. (…) Without our commitment to such elemental justice, the next Tuskegee is surely now being planned.”[29]

Her 2001 warning may appear prescient, and it actually was for the SUPPORT study and its international NeOProM siblings which were conceived about two years after her editorial predicted them. However, the protection-withholding and blatantly patient-abusing LIGHT-ROP study had already been published three years earlier.  Moreover, she was mostly concerned with ethics violations to be feared for US studies in often poor foreign countries, but it turns out that these new transgressions, even worse than the Tuskegee and Guatemala syphilis studies, were occurring right here in the US, and despite all the supposed safeguards in this country.

The dysfunctional US patient-protection system allowed those SUPPORT researchers to bark up the wrong tree while conflating blindness with death and to recklessly kill 23 babies in their poorly conceived and useless but patient-abusing trial. Just like the ethics violations in the earlier LIGHT-ROP study, the plans for this predictable mass slaughter bypassed all the alleged safeguards of the alleged patient protection system in the US, this time even more openly but equally unchallenged. They also escaped all scrutiny in the other  trial countries who follow the same heavily US-influenced pediatric doctrine.

So, how could this direct disregard of all relevant ethics codes and government regulations have been tolerated in the US which claims to have erected powerful “never again” barriers against human rights abuses like those in its past for which it publicly apologized? And how could these current open violations have been approved at all levels of the medical research hierarchies in so many different countries, without anyone giving at least some lip service to those ditched international ethics codes and regulations?

Some cynics may point out that the death of an asphyxiated baby is much less likely to result in a malpractice suit than his or her survival with a major disability and lifelong financial burden, and that this distortion of risk may bias some doctors towards preferring to see a vulnerable baby die. Moreover, eliminating ROP among the survivors would greatly reduce the profits from the elaborate oxygen monitoring as well as the need for costly repeat retinal examinations and laser surgery and drug treatments. It would also render obsolete much of the expensive high-tech RetCam equipment for checking the progress of the retinal detachment which often parent-led local fund drives provide to more and more intensive care nurseries. And admitting the role of the doctor-specified nursery lighting in the decades-old and continued blinding epidemic would expose many hospitals and doctors as well as probably some medical academies and agencies to major liabilities and unwinnable litigation.

Although such considerations may at times influence some of the researchers and grant approvers, there is no reason to suspect such materialistic motives among the usually well-meaning great majority of nursery doctors. Most of them simply do in good faith what their doctrine has taught them to do, and they are apparently gullible enough to accept that baby-blinding doctrine blindly, just as they blindly accepted until 1985 that babies don’t feel pain and can be subjected to major surgery without anesthesia.

This brings us to the second of the two unethical trials I mentioned at the beginning of this letter and that established this false doctrine with a blatant but never acknowledged research fraud.

Continue here to part 2 of this complaint about oxygen-withholding studies

Go here to the "Informed Consent" forms for the SUPPORT study



[1] Support Study Group of the Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network: "Target Ranges of Oxygen Saturation in Extremely Preterm Infants", posted May 16, 2010, by the New England Journal of Medicine at http://www.nejm.org/doi/full/10.1056/NEJMoa0911781

[2] Askie LM, Brocklehurst P, Darlow BA, et al.: “NeOProM: Neonatal Oxygenation Prospective Meta-analysis Collaboration study protocol”, BMC Pediatrics, January 17, 2011, see page 10 for the description of the founding group, and Table 1 on pages 28 to 30 for a comparison of these five parallel studies; this article is posted at http://www.biomedcentral.com/content/pdf/1471-2431-11-6.pdf; the Canadian study has the acronym COT.

[3] Support Study Group of the Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network: "Target Ranges of Oxygen Saturation in Extremely Preterm Infants", posted May 16, 2010, on the website of the New England Journal of Medicine, see page 2 left at http://www.nejm.org/doi/full/10.1056/NEJMoa0911781

[4] Askie LM, Brocklehurst P, Darlow BA, et al.: “NeOProM: Neonatal Oxygenation Prospective Meta-analysis Collaboration study protocol”, BMC Pediatrics, January 17, 2011, see page 7 for the death toll estimate for an unspecified area, as posted at http://www.biomedcentral.com/content/pdf/1471-2431-11-6.pdf; the estimate of 150,000 deaths in 20 years appears low when compared with my separately derived extrapolation from autopsy reports of the first five years. These suggested a death toll of about 16,000 preemie deaths per year in the US alone over the first five years of the oxygen rationing, see http://retinopathyofprematurity.org/26allegedstudyresults.htm.

[5]  One of the studies in the SUPPORT researchers’ sampling was 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, as discussed at retinopathyofprematurity.org/28laterdeaths.htm. These authors reported eight to eleven per cent more preemie deaths in the continuously oxygen-monitored groups, with a probability of 94 per cent that the deaths were related to the tighter monitoring.

[8] Askie LM, Brocklehurst P, Darlow BA, et al.: “NeOProM: Neonatal Oxygenation Prospective Meta-analysis Collaboration study protocol”, BMC Pediatrics, January 17, 2011, see pages 10 and 11 for the 4 per cent death toll prediction among study subjects, as posted at http://www.biomedcentral.com/content/pdf/1471-2431-11-6.pdf;

[9]  CBS "Sixty Minutes", 1/19/1992

[10] Jeremy Hsu: “One Medical Atrocity Infects Truth About Another”, LiveScience, October 7, 2010, quoting Professor Susan Reverby, the re-discoverer of the Guatemala study. http://www.livescience.com/history/medical-research-guatemala-experiments-101007.html

[11] From the Per Curiam Opinion filed on October 11, 2001, in Circuit Court for Baltimore City Case numbers: 24-C-99-000925 and 24-C-95066067/CL 193461, as posted near the end of http://www.courts.state.md.us/opinions/coa/2001/128a00.pdf

[12] Bernard Gavzer: “Can Light be Dangerous for Babies?” Parade Sunday Magazine, June 1, 1997, page 4, see retinopathyofprematurity.org/ROPparademagazine2.htm

[13] See at http://nfb.org/legacy/convent/tb1957.htm the 1957 speech “The Cross of Blindness” in which Professor Jacobus tenBroek, an early President of the NFB, discussed the founding principles of this organization. See also the motto in the masthead of the NFB website’s home page: “If a blind person has proper training and opportunity, blindness can be reduced to a physical nuisance.

[16] Plato: “The Republic”, Cornford Translation, XXVI, 527D, Oxford University Press, London, 1941, page 244.

[17] G.F. Simmons: “Calculus Gems – Brief Lives and Memorable Mathematics”, McGraw-Hill, 1992, page 162 top

[18] See the book review of Robert Kaplan’s “Hidden Harmonies”, Bloomsbury, 2011, at http://www.sciambookclub.com/pages/nm/product/productDetail.jsp?skuId=1068845844&source=igodigital

[20]  W V Good and S M Carden: “Retinopathy of prematurity”, Br J Ophthalmol. 2006 March; 90(3): 254–255, citing WHO's mission for vision Afr Health. 1998;20:38, as posted at http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1856945/ 

[23] H R Taylor, M L Pezzullo, and J E Keeffe: “The economic impact and cost of visual impairment in Australia”, Br J Ophthalmol. 2006 March; 90(3): 272–275. See http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1856946/ 

[24]  K D Frick and S M Kymes: “The calculation and use of economic burden data”, Br. J. Ophthalmol. 2006;90;255-257; see http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1856947/pdf/255.pdf

[25] SISSON TRC, GLAUSER SC, GLAUSER EM, TASMAN W, KUWABARA T. Retinal changes produced by phototherapy. J Pediatr 1970: 77: 221-7 (page 225 middle left). 

[26]  GLASS P, AVERY GB, SLUBRAMIANIAN KNS, KEYS MP, SOSTEK

AM, FRIENDLY DS. Effects of bright light in the hospital nursery on the

incidence of retinopathy of prematurity. New Engl J Med 1985: 313: 401-4

[27]  See relevant excerpts from this light damage literature in Aleff H P: “Baby-blinding retinopathy of prematurity and intensive care nursery lighting”, Iatrogenics, April-June 1991: 2: 68-85, posted at http://retinopathyofprematurity.org/Babyblindinglights01.htm

[29] Reverby SM: “Tuskegee: Could it happen again?”, Postgraduate Medical Journal, 7, 2001; 77:553-555.

 
 

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