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 The influential 1955 study of withholding oxygen from preemies

 

was rigged to eliminate the preemies most at risk for blindness

 

 
 


Part 2 of my open letter to Professor Amy Gutmann

at info@bioethics.gov

University of Pennsylvania President and
Christopher H. Browne Distinguished Professor of Political Science &
Chair of the Presidential Commission for the Study of Bioethical Issues

from Peter Aleff, 2097 Cottonwood Drive, Vineland, NJ 08361  February 22, 201
1
prevent@retinopathyofprematurity.org

The lingering lethal legacy of a rigged multi-hospital trial

The doctrine of quietly asphyxiating premature babies to save them from having to grow up blind has been entrenched among neonatologists and pediatric ophthalmologists ever since the alleged results of the multi-hospital “Cooperative Study of Retrolental Fibroplasia and the Use of Oxygen[30] condemned oxygen as the most probable cause of ROP and were announced in 1954 and 1955, then formally published in 1956.   

This was the other unethical study of blinding premature babies that I mentioned at the beginning of this letter. It triggered the above-mentioned wholesale carnage of baby-killing by oxygen-withholding -- an estimated 16 dead for every case of blindness prevented, and 150,000 or more “extra” preemies killed in the first 20 years. A slightly less severe form of that radical oxygen withholding continues routinely today in intensive care nurseries around the world as a legacy of this never replicated Cooperative Study, and the influence of that study is also still reflected in such “better dead than blind” oxygen-withholding research as the baby-asphyxiating SUPPORT trial.

 

The reasoning behind the oxygen-withholding idea

The trumped-up indictment against oxygen as alleged cause of ROP originated several years before that big Cooperative Study in a discussion at the June 23, 1948, meeting of the American Medical Association’s Section on Ophthalmology.  That discussion followed the reading of a lengthy technical paper by Dr. Algernon B. Reese about the clinical development of retrolental fibroplasia (as ROP was then still called). In that paper Reese had again tried to show, as he had done before, that ROP was a congenital defect present before birth in the embryonic stage. For more information about Reese and his intellectual environment rooted in the pseudoscience of eugenics, see http://retinopathyofprematurity.org/20oxygeneugenics.htm

The Abstract of Discussion was written by a Dr. Brittain F. Payne who, like Reese, hailed also from New York and may be the same Frank Payne who had co-authored with Reese a 1945 presentation on the same topic with the same conclusion.  Payne had been asked to comment on Reese’s just presented paper, and he clearly shared Reese’s views about the congenital nature of ROP.  He blamed "defective germ plasm" as playing an important role in the etiology of the eye damage, and he proposed to solve the problem by not preserving the “defective persons” at risk for it. This suggestion appears to have triggered that large-scale, oxygen-condemning Cooperative Study as a means to eliminate those “defectives” on the sly, and the resulting mass infanticide from oxygen withholding that still continues.

Here is how Payne concluded his rendering of that discussion, as edited and published by Reese who was then the editor of the American Medical Association’s “Archives of Ophthalmology” where he printed his paper as the lead article followed by that “Abstract of Discussion” in the May 1949 issue:

“Just why the fibrotic changes occur as the embryo develops and become exaggerated after birth is not known.  Among the causes given are avitaminosis and intercurrent infections in the mother, but it is also thought that defective germ plasm plays an important role.

The problem of retrolental fibrosis has at least three aspects:  1. Prevention by selection of parents without ocular defects of this type.  Let “fate” settle the problem of existence of these defective persons.  Obstetricians and pediatricians should not be so zealous in preserving defective persons, of which the world has a sufficient quantity already.  2. Medical and surgical treatment.  Therapy has not been successful, but there is hope that more progress will be made as time goes on.  3. The adjustment of the defective child and its family to the unpleasant situation of blindness and dementia.  This may be the most important phase.

It is a great privilege to have been asked to discuss this excellent paper on a disease of the eye so little understood and about which so little can be done.  The essayist has given us new insight.”[31] [emphasis added]

Payne's now shocking recommendation against preserving potential “defectives” as well as his suggestion to prevent the disease “by selection of parents” reveal that he and his audience of mostly ophthalmologists continued to believe in the pseudo-science of eugenics which had been fashionable during their study years.  His unwarranted association of the blindness with the entirely unrelated dementia is another telltale sign for the survival of that belief since it had been a favorite tactic of the earlier eugenics crusaders to label anyone they deemed undesirable as “feebleminded” or "demented". 

You will find at retinopathyofprematurity.org/20oxygeneugenics.htm a description of the American eugenics movement, its attitude of eliminating “weaklings” such as premature babies, and its particular emphasis on trying to eradicate blindness which has influenced many ophthalmologists to this day.   

The only means available to doctors at that time for “zealously preserving” newborn preemies gasping for breath was to give them generous breathing help with supplemental oxygen, to compensate at least in part for the immaturity of their lungs and their inability to absorb enough of that life-saving gas from its usual concentration of only 20 per cent in normal room air.  Dr. Payne’s recommendation to “not be so zealous in preserving defective persons” amounted therefore to a recommendation to withhold that life-saving gas from preemies so that they would not survive as blind persons, and to blame their deaths not on the intentionally lethal oxygen-throttling by their doctors but instead on “fate” where the original quote marks indicate that this was meant as a subterfuge.

The first step towards “not preserving the defectives”
who might go blind

That “Abstract of Discussion” was published in May, 1949.  Shortly after that, Dr. Leroy Hoeck, director of the intensive care nursery at the Washington, D.C., Gallinger Municipal Hospital, mused to Dr. Arnall Patz, a young ophthalmologist resident from nearby Baltimore, Maryland, that high oxygen concentrations given to the babies might be involved in their blinding. Patz “dropped the matter for a while”, initially dismissing that idea as unlikely on theoretical grounds. Then, “in late 1949”, Patz changed his mind and began to design a clinical trial to test the influence of oxygen on ROP in the intensive care nursery.  He proposed to assign premature infants in alternate order to incubators with either routinely high or low oxygen enrichment[32]

Despite the long history of oxygen as a non-blinding life saver and its perfect alibi in the case of ROP which appeared only many decades after giving oxygen breathing help had become an intensive care nursery routine[33], Patz and Hoeck received the requested grant for their oxygen-restricting study with relatively little discussion.  Silverman described how the reviewers at the National Institutes of Health initially criticized that grant application as:

“... weak in scientific merit and with extreme concern by the pediatric referees that ‘... these guys are going to kill a lot of babies by anoxia to test a wild idea.’  Patz and Hoeck satisfied the objections of the referees by stating ‘to avoid having deaths from lack of oxygen, every baby in the low oxygen group would be maintained at a healthy pink color’.  The $4000 was granted.

The nursery trial proved to be difficult for the investigators.  Patz found that ‘the nurses were convinced that we were going to kill the babies in the low oxygen group, and indeed, at night some of the older nurses would turn the oxygen on for a baby who was not receiving oxygen, then turn it off when they would go off duty in the morning.’”[34]

Patz and Hoeck claimed to have significantly reduced the incidence of ROP in their “low-oxygen” group, but they conspicuously omitted to provide the mortality numbers from their experiment, although the fear of more deaths from oxygen withholding had been the main objection to the plans for their trial[35].

 

Smearing the reputation of life-saving oxygen breathing help

The reservations of reviewers and nurses against oxygen withholding, and the inability of the trial designers to prove the safety of their radical departure from the routine life-saving oxygen supplementation, showed that the until then unblemished reputation of oxygen as a safe and effective life saver had to be changed first before the idea of blaming it for the blinding could become acceptable. 

Accordingly, some proponents of oxygen withholding began an international smear campaign against that until then so beneficial gas, and we can observe in the medical literature of the time how that campaign unfolded. The discrediting of oxygen appears to have been driven by comments from a few individual doctors who shared the same eugenicist ideology, and who were all connected directly or indirectly to Reese.  They all read and heard the same views and interpretations in their journals and meetings, and their small group of medical opinion leaders had the willing ears of their receptive colleagues. The internal echoes of that group’s buzz about oxygen appear to have reinforced their mutual convictions and to have won over, or at least silenced, the doubting ones.

One of the most profuse among those early oxygen-accusers was Dr. Philip Jameson Evans, a prominent ophthalmologist in Birmingham, England.  He expressed in March 1951 his views about the infant's need for "an oxygenated blood supply acquired by its own efforts", and he continued, in words that sound as if he had borrowed them from the earlier eugenics advocates:

"Prior to 1930 [sic - please note that ROP began only in 1940] oxygen was not given so frequently as a routine or for such prolonged periods, or at so nicely uniform a level as today.  Now [the infant] lives in a constant atmosphere of moderately high oxygen concentration (...) and certainly without the stimulus to private enterprise: hence an inertia results as we find in other human activities when over-subsidized. (...) They have oxygen 'on the State' (...) Perhaps this is only one further instance of the modern trend to save the individual from having to work his best to live, and perhaps our treatment is in fact the reason why this disease has now appeared."[36]

In July of that same year, Dr. Kate Campbell, a neonatologist from Melbourne, published an article in The Medical Journal of Australia in which she said “colleagues returning from overseas” had suggested that oxygen might be responsible for the eye damage.  She then described that her own general comparison of three nurseries with different means for paying the costs of oxygen seemed to confirm this suspicion.  She concluded that preemies should not receive any oxygen supplements unless they turned blue from its lack, and if that happened because of a congenital cardiac defect, then “vain efforts should not be made to improve the infant’s colour with oxygen”[37]

Campbell’s informants had visited Birmingham, England[38], so this earliest published clinical indictment against oxygen appear to have been inspired by Evans’ anti-subsidy rantings.

A year later, Evans and Dr. Mary Crosse, his like-minded colleague in Birmingham, continued the slander against oxygen, this time in the respected American journal Archives of Ophthalmology, as edited by Reese:

"Prior to the modern technique of oxygen administration, the premature infant fought out its struggle for oxygenation. (...)  It seems that, as in domestic and national policies, a prolonged subsidy paralyzes the ability to struggle which would otherwise have had the opportunity to develop, and that the disease has, in fact, been artificially induced by a well-intentioned, but misguided, change in the management of such cases.  That a return to a less indulgent care of the premature infant prevents the disease should be appreciated as soon as possible, and cannot be too quickly undertaken."[39]

This labeling of oxygen as a subsidy made it ideologically intolerable to the many doctors who still shared the eugenics movement’s “survival-of-the-fittest” aversion against any help for the struggling.  Add to this that during those McCarthy-era communist-hunting years in America, it was not necessary for charges of leftist connections to be proven to be widely believed.  In this atmosphere, Evans’ rhetorical insinuations against the until then "life-saving" gas found a ready reception in American medical circles, as the actions of their members would show. 

Psychology textbooks describe a condition called projective identification and action discharge of disturbing internal stimuli[40]. This condition is common in political debate where people who feel threatened mistake the symbol for the real thing it represents. Obediently following those textbooks, the American community of nursery doctors reacted to the red-painting of oxygen “subsidies” like a bull to red cloth. 

The American Medical Association had just spent $1.5 million in 1949 and $2.25 million in 1950 to defeat President Truman's National Health Insurance proposal, in what was back then the most expensive lobbying effort in American history. With twists that look eerily familiar to any follower of the recent US debates about health insurance reform, the doctors’ advertisements back then had linked British-style National Health Insurance with socialism and even with fabricated Lenin quotes[41], and the political fever inflamed by this type of slander continued to run high for years later. 

For instance, the Guest of Honor at the 1953 Annual Session of the American Academy of Ophthalmology and Otolaryngology declared that socialized medicine was "a terrible blow to the art of practice" and a "serious threat"[42].  This emotional and political context made it easy for the American pediatric leaders to continue linking that socialist threat with the oxygen that Evans and some of his colleagues had already connected to the dreadful evil of “subsidies” dispensed by a loathed socialist system. 

Launching the big bogus study of oxygen withholding

In the early 1950s, as the first large cohort of children blinded in American nurseries reached the age to go to school, the nursery doctors came under pressure to end the intensive care nursery epidemic which the overwhelmed providers of services to blind people had begun to perceive as an urgent national problem[43]. Ending the stream of blinded survivors by throttling their oxygen “subsidies” was still the convenient solution for a profession which had just demonstrated how little the public interest meant to its members.

Although the initial trial by Patz and Hoeck had shown less blinding in the low-oxygen group, it was useless for convincing the skeptics because, as mentioned above, the study authors had conspicuously omitted to report the respective mortality rates in the routine versus low oxygen groups, and some readers may have wondered why they had not mentioned this important outcome.

A new and more authoritative study was needed, and here is Silverman’s eyewitness account about the relevant meeting in which he took part:

"... a small number of pediatricians and ophthalmologists met at the height of the retrolental fibroplasia epidemic in 1952. (...) The conferees began to argue vociferously about whether supplemental oxygen was or was not the cause of the RLF epidemic. At the height of the debates, Franklin Foote, Director of the National Society for the Prevention of Blindness, got up and reminded everyone that the blindness epidemic was an urgent national problem. 'We are not going to make any progress,' he said, 'if we continue to argue in this futile way. We need to think about what constructive action needs to be taken to hasten the end of this epidemic that has completely overwhelmed this country's facilities for the care of blind children.'  From that point on, the meeting took off in a very different direction.  After very little discussion, the participants agreed on the urgent need for a definitive test of the burning question about the role of supplemental oxygen." [44]

To be fair, not all of those in the meeting joined the bandwagon. Silverman noted also in that same account that

"One splinter group felt that limiting oxygen would require infants to undertake an unjustified risk of death and brain damage."

However, the result of this meeting illustrates how easily political pressure can lead to the omission of all ordinary scientific precautions.  The outcome of this little discussed agreement was a plan to reduce the number of children growing up blind, and the means to pull this off was going to be the 18-hospital Cooperative Study of Retrolental Fibroplasia and the Use of Oxygen.  Its designers made no provisions to check in the aftermath of their hit-and-run trial for the mortality their oxygen withholding was bound to create, or for the less immediately visible damage which they knew would afflict the brains of those whom they had deprived of oxygen. They simply wanted to eliminate the “defective persons” whose “defective germ plasm” predisposed them to become blind, and who would flood the facilities for the blind if they were allowed to survive

To achieve this goal of not preserving “defectives”, as recorded from their meeting in June, 1948, they rigged that study as a blatant scientific fraud.

 

The scientific fraud in the bogus oxygen withholding study

The designers of that Cooperative Study of Retrolental Fibroplasia and the Use of Oxygen rigged the study procedures to hide and falsely deny the fatal danger of oxygen withholding.  They knew that the preemies most at risk for ROP were the most immature ones with the lowest birth weights and the most immature eyes, and that these had also the most immature lungs, as documented in some of their statements quoted at http://retinopathyofprematurity.org/23oxygenstudyfrauds.htm.

These authors were further fully aware that babies with immature lungs who need help with breathing need this help right away, particularly during the first 12 to 24 hours, or else they will succumb quickly to their respiratory problems.  This is evident from pediatric textbooks of their time, again as quoted in detail at retinopathyofprematurity.org/23oxygenstudyfrauds.htm.

Knowing all this, the trial designers delayed the enrollment and the beginning of most oxygen administration until the babies were 48 hours old.  By that time, 634 had died, and 786 survived to be enrolled.  Only 52 of these survivors had received any supplementary oxygen at all during their first two days[45], presumably from nurses like those at the Gallinger hospital cited above who had preferred helping the babies instead of blindly obeying doctors’ orders. 

The 45% of the babies who had died in those two days included, predictably, most of those who would otherwise have survived to grow up blind.  For comparison, the death rate among the 437 preemies born at less than 2000 gram in one of the participating hospitals during the immediately preceding years 1950 and 1951 had been 32% within the first seven days[46]. If that 32% rate of deaths had been maintained during the Cooperative Study, its death toll would have been about 454 babies, but its designers deliberately killed 180 more with their intentional oxygen withholding.

However, that protocol of killing the patients most at risk for blindness before their deaths would be counted concealed the sharp rise in mortality which the perpetrators of this grotesque experiment knew their cure worse than the disease would produce.  This deceptive trick allowed the kangaroo-court of show-trial judges to announce its knowingly false verdict that the oxygen withholding had virtually ended the blinding but had not affected the mortality rate.

Other signs that this study had been planned as a deliberate fraud are numerous.  For instance, long before any data from the study came in, Reese had expressed his hope that oxygen would be “successfully incriminated”[47], a bias in favor of this outcome that ruled out any objectivity in his evaluation.  And when the preliminary results did arrive, he led the meeting in September 1954 where he introduced as well as closed the prolonged presentation of the pre-arranged outcome from that study that oxygen was the culprit[48]. 

Yet, Reese's own writings on ROP show that he could not have believed a word of his accusations against the oxygen scapegoat because he had consistently maintained until then that the blinding was “without doubt” due to prenatal causes.  As late as 1952, he had written another long paper in which he claimed again to have found ROP in the eyes of stillborn infants. He concluded again that the disease could be present at birth although demonstrable evidence for it at this early age was the exception:

“We find the typical pathology of retrolental fibroplasia in two sets of eyes obtained from infants who died at or shortly after birth. We can say, therefore, that the disease can be prenatal.  This is supported further by the rare occurrence of typical retrolental fibroplasia being seen clinically at birth.  If it can be assumed that skin hemangiomas have a common cause with retrolental fibroplasia, then we know that approximately 20 percent are seen at birth.  In the large majority of the cases of retrolental fibroplasia, however, there is no demonstrable clinical or histologic evidence of the disease at birth.” [49]

Although Reese’s “if it can be assumed ... then we know” style of thinking may have allowed him to bypass some rules of conventional logic, he still could not honestly have blamed postnatal oxygen administration for a condition he so firmly believed to exist often already at birth and to have prenatal causes.

Moreover, Reese and his like-minded colleagues knew quite well that preemies had received ample oxygen for many decades without ever suffering a single case of ROP, and that this long-proven remedy could therefore not suddenly have begun to cause the never previously encountered blinding. 

The scientific flaws in that trial included also statistical slight-of-hand that alleged to separate the babies' need for oxygen from their immaturity, although one is clearly a function of the other.  A correlation between the pulmonary immaturity which makes the babies need oxygen and the ocular immaturity which predisposes them to ROP must be expected but is meaningless, as "The Oxford Textbook of Medicine" explains in more general terms, translated here in parentheses to match the case at hand:

"If factor A [the baby's immaturity] influences both factor B [the need for oxygen] and disease C [ROP], factor B and disease C will be associated statistically. The association between B and C will, however, be non-causal and there would be no hope of producing a change in disease C by manipulating factor B."[50]

 

Proclaimed results of the bogus oxygen withholding study

Despite the frauds in the enrollment timing, the thumb on the risk-weighing scale, the contrived statistics, and the other examples of bias in that study, the compiled data still did not really condemn oxygen.  They specifically exonerated variations in the concentration of the gas because these had exerted no influence on either the incidence or the severity of the disease[51].  They also showed that the severity of the damage was unrelated to the length of exposure to supplemental oxygen[52]

The entire blame against oxygen was based on an alleged correlation between that length of exposure and the incidence of the disease, as asserted in the "Comment" and "Summary" sections of the report.  However, buried in the middle of the 48-page paper you find the qualification that even this unsurprising correlation was “statistically significant” only for the first one and a half to three days after the enrollment in the study at the age of two days [53]

In clinical terms, all this bogus multi-hospital trial had achieved was to rediscover again what many other observers had previously noted and what no one had ever doubted: that the more immature preemies are more likely to suffer from ROP than the more mature ones, and that they also need oxygen for a longer time.

The mountains had labored mightily to bring forth a minuscule mouse, so the trial designers inflated that mouse to look like a lion.  This lethal, unscientific, and answer-less bogus study received much praise as a medical breakthrough, a splendid success for the then relatively new conceptual tool of double-blind controlled clinical trials.

Indeed, that bogus study was highly successful in that it led to exactly the merciless large-scale euthanasia program against preemies which its designers had meant it to produce -- it bears repeating that their current emulators from the SUPPORT and NeOProM studies cited an estimated 16 deaths per case of blindness prevented, and 150,000 babies killed in the first 20 years of that program. This spectacular success in radically reducing the number of preemies surviving with blindness is said to have been one of the major reasons for the large expansion of Congressional appropriations to medical research which began in the late 1950s[54] 

Reese received a shower of medals and prizes, many of them presumably for his leadership against the epidemic of baby-blinding, as well as honorary memberships in the ophthalmological societies of Greece, Cuba, Mexico, Australia, Chile, Panama, France, and New Zealand[55].

Continuity of the preemie-disdaining medical mindset

The eugenicists’ frame of mind expressed by Reese continues among some of his later colleagues. As an anecdotal but maybe typical illustration of how this view of preemies as undesirable and disposable still taints the view of some stubbornly diehard doctors today, let me quote this 2010 email comment from a recently retired professor of ophthalmology in a southern US state who tried to justify the euthanasia routinely practiced against preemies back when this was the openly accepted fashion in his profession, and even now when it is applied less openly but no less lethally.  The context suggests that he means euthanasia when he says eugenics, and his placing the depression into the early 1900s matches his general confusion:

“Eugenics was considered by many learned men in the early 1900s, primarily because there was no government support system in place to care for these handicapped infants; remember this was the time of the depression and many even healthy babies were abandoned by their parents. This abandonment to a lesser extent continues today.”[56]

This usually unacknowledged and almost subconscious persistence of the once dominant eugenics-inspired and now still widespread “better-dead-than-blind” medical approach to preemies and blinding is what many medical students absorbed as part of their indoctrination, and what led the SUPPORT authors to lump death and blindness together into the same category of severity. Many honest but doctrine-believing doctors may well be convinced that they do a favor to the baby and and his or her family if they prevent a newborn from growing up blind or with some other impairment and so from passing on the “defective genes”. 

The persistence of the oxygen restrictions, despite the lack of any evidence for their effectiveness as prevention against the blinding, and despite the clear evidence for the increases in mortality associated with them, shows that the misguided eugenicist prejudice against blindness that led to this throttling of the life-saving gas is equally persistent.

Meanwhile, the oxygen-blaming and light-ignoring doctrine based on the above research fraud from over half a century ago continues to cause daily much suffering to many children and their families around the world, as the SUPPORT study illustrates. That suffering may even be getting worse because the medical fashion is now returning to openly blame the old standby of "defective germ plasm" which it renamed "genetic factors" to suit modern tastes.

ROPARD.org, the official medical fundraising organization for more research about “ROP And Related Diseases”, has attempted for several years to again confuse the issue, just as the original oxygen-study designers had done. To begin with, they falsely imply that ROP is related to other diseases, and they claimed for a time on their website that “ROPARD research has begun to identify a genetic link between premature birth and retinal detachment.”[57]

ROPARD offers no more evidence for this alleged genetic link, or for any reason to pursue the genetic research about ROP they advocate, than there ever was for the “defective germ plasm” theory of the earlier eugenicists that led to the oxygen fraud.  However, a more recent retrospective study of preemie twins, published in the November, 2006, issue of Pediatrics, pretends again to have determined that genes are a major factor in ROP.  It states that a component of the analysis

“factored in the potential effects of unidentified factors (...) (i.e., [a list of five suspected] variables not available from our data set) (...) in addition to unknown unidentified factors. By modeling the effects of these non-genetic components, we were able to determine that 70.1% of the variance in liability to ROP was attributable to genetic factors alone.”[58].

This ultra-precise-appearing number of 70.1% is entirely fictitious. Like many of its predecessors in the notoriously fraud-ridden history of eugenic twin studies, it rests on arbitrary ad-hoc estimates fitted to unwarranted assumptions, such as treating the outcomes from twin pairs as correlated events although the study was meant to find out whether these outcomes were related to the genetic similarity of twins. This circular reasoning highlights again the futility of the alleged peer review process for medical papers because the authors' own words reveal their fallacy to any attentive reader. Moreover, their "known" factors, such as the co-variates of gestational age and duration of supplemental oxygen use, are statistically inseparable from each other as well as from the incidence or severity of ROP. See reference [50] above. They can therefore not be mathematically controlled for, as the authors pretend to do, by separating out their postulated influence on the blinding.

Most absurdly, the authors claim to have controlled their results for several named unknown plus any “unknown unidentified nongenetic factors”. Any such claim owes more to magic, the ancient but forever futile attempt to wield power over the unknown, than to statistical mathematics which requires a more rational attitude. By definition, if one wants to control statistically for a factor then this factor and its effects must be known to be so quantified. Anyone who pretends to control for unknown and/or unidentified factors matches ipso facto Webster’s definition of a quack: “one who pretends to skill or knowledge which he does not possess.”[59]

This fake study has the scientific value of a horoscope because its authors dress up their hunches and predetermined conclusions with elaborate-sounding but mostly hidden computations the way astrologers do. Yet, this self-evident neo-eugenic nonsense was prominently published in the flagship journal of the American pediatric profession and then gullibly echoed in medical news releases around the world. It has thereby shown again, as during the first and meanwhile fortunately discredited attempt to sell eugenics as a science, that so-called medical “experts” need no evidence to proclaim whatever suits their agenda. They get away with practicing proof by assertion.

Potemkin agencies for false reassurance

The medical community does not appear to have any functioning safeguards against such agenda-driven patient abuses and glaring defects in its purported science. Theoretically, there are three layers of protection in the US medical research system: Institutional Review Boards at each of the hospitals or other institutions where the research is being performed, the Office for Human Research Protections which regulates these IRBs, and the Office of Research Integrity which is supposed to assure the soundness of the research. In practice, however, and despite alerts to these Offices, none of these protections kept the premature babies from being abused and even killed for worthless research in the SUPPORT study, or kept the medical doctrine from getting contaminated with the knowingly false results from the fraudulent LIGHT-ROP study, or cleaned up the old eugenicist corruption of that doctrine by the Cooperative Study of oxygen withholding.

According to a description from the website of Gallaudet University in Washington, D.C., “the purpose of the IRB is to inform and protect human subjects used in research. The IRB acts as an advocate for the research subject. This means that the IRB, during its review of a research project and the informed consent, has the right and responsibility to ensure that the research subject is fully informed of the procedures involved in the study as well as the risks”[60]. This sounds fine, but in the cases of both the LIGHT-ROP and SUPPORT trials, none of the IRBs at any of the hospitals involved raised any objections against the lethal or harm-increasing liberties the researchers took with their preemie subjects.  The IRBs all rubber-stamped these rogue research proposals although in both cases the violations of the rules regulating the research were flagrant.

The IRB members are supposed to have enough experience, expertise, and diversity to make an informed decision on whether the research is ethical, informed consent is sufficient, and appropriate safeguards have been put in place. That may be the theory, but compare this with the minutes of the IRB meetings at the Buffalo study site of the LIGHT-ROP study which I obtained under the Freedom of Information Act through the OPRR:  the IRB reviewed the ongoing studies there annually and approved them each time in perfunctory pro-forma meetings.  The average time spent per item on the long agendas for the rather short IRB meetings there ranged from 3 minutes 7 seconds in 1991 to 45 seconds per study protocol in 1995.  

Any “review” conducted in such haste is obviously insufficient, and the unanimous approvals a few years later of the clearly patient-abusing and safeguard-lacking SUPPORT trial suggest that those IRBs did not devote much attention to that study either. This first line of defense for the protection of patients from medical research abuses is thus only a dangerous illusion, and it would be more honest to just abolish such IRBs instead of pretending that they protect patients. 

The Office for Human Research Protections (OHRP) regulates and oversees the IRBs and “provides leadership in the protection of the rights, welfare, and wellbeing of subjects involved in research conducted or supported by the U.S. Department of Health and Human Services (HHS)”, as stated at the beginning of its website home page.  Your predecessor at President Clinton’s National Bioethics Advisory Commission had transmitted my complaint about the unethical LIGHT-ROP study to that Office in April, 1997, when it was still called the Office for Protection from Research Risks.

After almost a year of prodding and repeated interventions by US Congressman Frank A. LoBiondo who represents my district, that Office released in March, 1998, a stack of paperwork about its “investigation” which showed that it did not even pretend to look seriously into my charges of patient abuses and warnings about the nursery lights.  Already the first memo that started the sham internal probe included in parentheses a "talking-point"-style suggestion that revealed the OPRR's predetermined conclusion: "it is just a given that there will be bright lights."  The results of that probe reflected this initial pre-judged coaching and found nothing wrong with the gross ethics violations in the LIGHT-ROP study. This ultimate arbiter of IRBs can therefore not be trusted any more than these, and here again, it would be more honest to just abolish this deceptive Office instead of using it to project a dangerously false sense of security. Alternatively, replace the medical managers and staff with non-medical people whose judgment is not captive to the medical guild they supervise.

My experience with the Office of Research Integrity was not any better.  I wrote in September, 2006, to its Co-Chair for the then upcoming World Conference on Research Integrity, Dr. Nick Steneck, to alert him to the frauds in the Cooperative Study of oxygen withholding and the LIGHT-ROP study.  I described to him the harm these bogus studies continued to inflict daily on many preemies around the world and asked him to help correct these festering falsehoods in past research and to restore the integrity of the medical doctrine.  He thanked me for bringing this case to his attention but continued

“With so many issues and countries to consider, we will likely not have time to consider individual cases in detail. Our main goal for this conference is to find ways for countries to harmonize policies and communicate concerns.  I will keep your concerns in mind as we plan the program for the conference.”

This Laputan indifference to well documented actual US research frauds which kept severely injuring thousands of premature babies in just about all the countries involved in that World Conference was apparently not a fluke. I re-submitted the documentation of those research frauds on the website of that misleadingly named Office of Research Integrity but received no reply at all.

This lack of interest in research integrity was not limited to the material I had submitted but was documented more generally last November in the Journal of Medical Ethics in an analysis of all PubMed clinical papers retracted between 2000 and 2010 compared with those for fraud[61]. This study found that when the proportion of fraud to all retractions was considered, the US came in a close second to India, with almost identical proportions of 0.32 versus 0.34, despite the telling difference that India does not have any equivalent to the US Office of Research Integrity. An article in The Telegraph of Calcutta explained:

“The US has had a government mechanism, now called the Office of Research Integrity (ORI), to promote integrity in biomedical and behavioural research and to handle cases of research misconduct for more than 20 years.

Although the US has this mechanism, this study provides no evidence that the ORI’s existence has led to a lower scale of misconduct.”[62]

This dismal overall performance of the ORI matches my anecdotal experience with its lack of interest in exposing or correcting the research frauds to which I tried to alert it. Its non-reaction was comparable to the Stock Exchange Commission’s lack of interest in the repeated warnings it had received against the infamous Ponzi Scheme of the financial felon Bernard Madoff.

Since medical doctors have strong incentives to protect the reputation of their guild against all perceptions of fraud, it is imprudent to expect from them much zeal in searching for and exposing clinical research frauds that could diminish the public’s trust in their profession. As with the Office for Humans Research Protections, the sensible choices are to either close that Office for Research Integrity, or else to replace its medical personnel with non-medical people who don’t have to worry about stepping on some cheating researchers’ toes.

Recommendations

To end the current blinding and other abuses of premature babies and to protect these from future transgressions by their intensive care nursery doctors, I submit the following suggestions:
 

1.) URGENTLY prevent the eyes of all babies, particularly the premature ones, from being exposed for even very short times to irradiation from the eye-damaging blue-violet energy spike of the fluorescent lamps now common in delivery rooms and intensive care nurseries. The eye damage from these lamps has mostly been limited to preemies, but occasionally even a term baby was said to have been diagnosed with ROP, and it is better to err on the side of caution in protecting all babies from these most eye-damaging wavelengths.


Means for preventing this exposure include, for instance, covering the fluorescent lamps with a suitable blue-blocking coating similar to the yellow paint used on “bug-lites”, placing yellow filters in all fluorescent light fixtures, and replacing the fluorescent lamps with softly shaded incandescent bulbs or LED lamps that do not emit the offending wavelengths.  Eliminate also all blue light from the ophthalmoscopes used to examine the eyes of babies, and keep all direct or reflected sunlight from shining on any baby’s face. 


2.) Stop the “better dead than blind” oxygen withholding policies. Maintain each preemie’s arterial oxygen level at least as high as in normal babies that breathe room air on their own.  


3.) Review all the currently doctrine-dominating medical research on oxygen toxicity and lung-enhancement steroid administration for preemies with technically competent non-medical people. This research cannot be trusted any more than the fraudulently introduced oxygen withholding doctrine which it may have been designed to support. Until such an independent critical review clears it piece by piece, all this research remains tainted with the same potential eugenicist bias as the
ROP oxygen studies. The goal of this review should be to establish a rational and non-ideological oxygen supplementation policy for preemies that is not distorted by the debunked allegations about oxygen causing ROP.

Better yet, establish an independent fact-check organization for all new medical research and established doctrine, as you and your panel recently did for new synthetic life experiments. While some of that latter work at the mostly microscopic level may have to be treated as confidential to protect intellectual property rights, any medical experiment on living people should be fully transparent. I suggest therefore to post the clinical study proposals and consent forms as well as trial results online and invite the public to help weed out unethical or incompetent proposals and to verify the logic of the conclusions.  The umpires for these proposals and comments should be from outside the medical profession.

This input from the public will work best if the rest of the relevant clinical literature is equally accessible. I suggest therefore further that you also review the fairness of the current gatekeeping system to clinical knowledge in which medical journals charge non-subscribers high fees for viewing even single articles even though the studies described in them were largely financed with taxpayer dollars and cost nothing to reproduce.
 

4.) Rethink the intensive care nursery environment to better meet the need of the preemies for quiet and mostly uninterrupted healing sleep in a peaceful environment without bright lights and ear-damaging noise, or even unnecessary vibrations of their incubators from the machinery attached to them.  The intensive care nurseries I have seen in person or on TV are mostly designed for the convenience of doctors making their rounds and nursery staff stuck in a time warp servicing the long rows of tightly packed incubators as if they were boxes on a conveyor belt.  That design is a cross between a mid-20th-century assembly factory and the equally bright and loud “Incubator Baby Side-Show” exhibitions at most major fairgrounds [63] which were in the first half of that century the public face and pride of neonatology.  This even back then unsuitable and now long obsolete design approach has no place in a nursery for fragile babies.

Preemies would be much better off in individual sound-dampening alcoves that protect them from the unnecessarily deafening alarms on every other incubator in the same room. Such alcoves would allow the babies to get some much needed sleep, and they would also offer some privacy to the parents who come to comfort their child. Modern closed-circuit TV and other technologies now make it easy to monitor the babies in those alcoves much better and more quietly than a nurse running back and forth between ear-piercing beepers all along the row.
 

5.) Hold rule violators, including all those involved with the SUPPORT study, fully accountable and enforce the current regulations, or else publicly announce that the US will no longer pretend to follow the Nuremberg Code or Helsinki Declarations or its own IRB approval rules.

Have all nursery doctors acknowledge and reject the frauds and other flaws in their oxygen-blinding doctrine so that they will not try to continue their present mistreatment of preemies with a stubborn adherence to their traditional ways. Have knowledgeable outsiders to the medical profession regularly audit the intensive care nursery procedures and patient outcomes.  Provide non-medical oversight for all agencies that approve study funding or review patient protection and research integrity.

Revise medical education to make today’s medical students less gullible and more critical about recognizing bogus research than many of the presently practicing nursery doctors. It is scary to entrust your child to members of a profession who believed until recently that babies feel no pain, and who still assert against all evidence that the still developing eyes of the most vulnerable among all patients will suffer no harm from doses of retinal blue-light-hazard irradiation that exceed by far the safety limits for robust adult workers, or that the constant and often deafening noise in the intensive care nursery does not harm the preemies’ ears although many of them are later diagnosed with hearing problems.

Have those students explain how this comment from the Skeptic editor Michael Shermer about economists applies also to the medical profession, and discuss the dangers of certainty inherent in this trap:

“Being deeply knowledgeable on one subject narrows focus and increases confidence but also blurs the value of dissenting views and transforms data collection into belief confirmation.”[64]

Teach them also that real medical ethics involves more than focusing on the promotional pens and pads and other trinkets that some doctors accept from sellers of pharmaceuticals.
 

I hope that you and your panel will agree with the common sense in these recommendations, and that you will act on them. President Obama vowed publicly that all human medical studies conducted today in or by the US will be held to exacting US and international legal and ethical standards. Will you be able to deliver on his promise, despite the wagon-circling resistance of a medical research tradition that has long been accustomed to sovereignly ignore all those standards?


Respectfully submitted,

Peter Aleff



     References:

[30] Kinsey EV. Cooperative Study of Retrolental Fibroplasia and the Use of Oxygen. Archives of Ophthalmology, 1956, 56: 481-543, see pages 527 and 528.

[31] Abstract of Discussion” after Algernon B. Reese, M.D., New York: “Persistence and Hyperplasia of Primary Vitreous; Retrolental Fibroplasia -- Two Entities”; in Archives of Ophthalmology, Vol. 41, Nr. 5, May 1949, paper on pages 527-549, quote on page 550 top.

[32]  As reported by Silverman WA. Retrolental fibroplasia: a modern parable. Grune & Stratton, Inc., New York, 1980, Chapter 4: "The Oxygen Hypothesis", page 28.

[33] See my page retinopathyofprematurity.org/22oxygenslander.htm for a documentation of earlier routine oxygen administration to premature babies.

[34] Silverman WA. Retrolental fibroplasia: a modern parable. Grune & Stratton, Inc., New York, 1980, Chapter 4: "The Oxygen Hypothesis",  pages 27-29, quote on page 28.


[35] Patz A, Hoeck LE, De La Cruz E: Studies on the effect of high oxygen administration in retrolental fibroplasia, American Journal of Ophthalmology, 3:(35), January 1952, pages 1248-1253.

[36] Evans PJ. Retrolental Fibroplasia. Transactions of the Ophthalmological Society of the United Kingdom, 1952, 71: 613-16, quotes on pages 613 bottom, 614 top, and 615 middle.

[37] Campbell K. Intensive Oxygen Therapy as a possible cause of Retrolental Fibroplasia: A Clinical Approach, The Medical Journal of Australia, July 14, 1951, pages 48-50, quote on page 49 right.

[38] Silverman WA. Retrolental fibroplasia: a modern parable. Grune & Stratton, Inc., New York, 1980, Chapter 4: "The Oxygen Hypothesis", see page 25.

[39] Crosse VM, Evans PJ. Prevention of Retrolental Fibroplasia. A.M.A. Archives of Ophthalmology, July 1952, 48: 83-87, quotes on pages 86 bottom and 87 bottom.

[40]  Langs R. The Listening Process, Jason Aronson, London, 1978, as cited in Godwin R. Dimensions of the American Political Mindscape, The Journal of Psychohistory, Summer 1993, 21: 1: 79-96, see page 84.

[41] Starr P. The Social Transformation of American Medicine: The rise of a sovereign profession and the making of a vast industry. Basic Books, New York, 1982,  see chapter on "Symbolic Politics, 1943-1950", 280-289, see pages 284, 285, and 287 bottom.

[42] Post LT. The Art of Medical Practice. Address of the Guest of Honor at the Annual Session of the American Academy of Ophthalmology and Otolaryngology in October 1953, Transactions of the American Academy of Ophthalmology and Otolaryngology, November/December 1953, 841-47, see page 842 top left: "Socialized medicine, an actuality in some countries and a serious threat in this, is a terrible blow to the art of practice."

[43] Silverman WA. Retrolental Fibroplasia: a modern parable. Grune & Stratton, New York, 1980, see Chapter 6: "The National Cooperative Study", pages 37-42, particularly pages 37 and 38.

[44] Silverman WA. Retrolental Fibroplasia: a modern parable. Grune & Stratton, New York, 1980, see Chapter 6: "The National Cooperative Study", pages 37-42, particularly pages 37 and 38;  see also Silverman WA. repeating this account in the discussion at the Ross Conference on Family Centered Neonatal Care, Burlington, Vermont, June 27-29, 1992, unpaginated transcript.

[45] Kinsey EV. Cooperative Study of Retrolental Fibroplasia and the Use of Oxygen. Archives of Ophthalmology, 1956, 56: 481-543, see Table 8A on last, unnumbered, page of  Appendix.

[46] Silverman WA, Blodi FC, Locke JC, Day RL, Reese AB: “Incidence of retrolental fibroplasia in a New York nursery”, Archives of Ophthalmology, 1952, 48:698-711, see page 698 for admissions, birth weight, and mortality.

[47] Algernon B. Reese: opening remarks in discussion after Norman Ashton: “Animal Experiments in Retrolental Fibroplasia”, presented in October 1953 and published in Transactions of the American Academy of Ophthalmology and Otolaryngology, January/February 1954, pages 51 to 54, quote on page 54 left, middle.

[48] Symposium: “Retrolental Fibroplasia”, presented at the Fifty-Ninth Annual Session of the American Academy of Ophthalmology and Otolaryngology, September 19-24, 1954, New York, published in the “Transactions” of that Academy, January-February 1955, Volume 59, No. 1, pages 7 to 41; see Reese’s remarks on pages 7 and 39.

[49] Algernon B. Reese, Frederick C. Blodi, and John C. Locke: “The Pathology of early Retrolental Fibroplasia”, American Journal of Ophthalmology, October 1952, Volume 35, No. 10, pages 1407 to 1426. See page 1425, right, for quote.

[50] Weatherall DJ, Ledingham JGG, Warrell DA., eds. Oxford Textbook of Medicine, 2nd ed. 1987, Oxford University Press, Volume 1, page 3.15 bottom left.

[51] Kinsey EV. Cooperative Study of Retrolental Fibroplasia and the Use of Oxygen. Archives of Ophthalmology, 1956, 56: 481-543, see pages 527 and 528.

[52] Kinsey EV. Cooperative Study of Retrolental Fibroplasia and the Use of Oxygen. Archives of Ophthalmology, 1956, 56: 481-543, see page 528 top.

[53] Kinsey EV. Cooperative Study of Retrolental Fibroplasia and the Use of Oxygen. Archives of Ophthalmology, 1956, 56: 481-543, see page 501 middle and 502 near bottom.

[54] Silverman WA. The Lesson of Retrolental Fibroplasia, Scientific American, 1979, 236: 6: 100-107, see page 105 right, near bottom.

[55]  Who’s Who in America, 1982-83, entry for Reese, Algernon Beverly.

[56] Personal communication on November 30, 2010, from a recently retired professor of ophthalmology in Tennessee who allowed me to quote him only on condition of anonymity.

[57] ropard.org/ropard_history.php as accessed March 5, 2007. On February 14, 2011, the earlier claim of a genetic link has been replaced by a statement that ROPARD supports “further genetic research” about ROP.

[58] Bizzarro MJ, Hussain N, Jonsson B, Feng R, Ment LR, Gruen JR, Zhang H, and Bhandari V: Genetic Susceptibility to Retinopathy of Prematurity, Pediatrics, November 2006, 118:5, pp. 1858-1863, quote on page 6 of the 12-page printout.

[59] “The Living Webster Encyclopedic Dictionary of the English Language”, The English Language Institute of America, Chicago,1971.

[60] As described by Gallaudet University in Washington, D.C., at http://irb.gallaudet.edu/

[61]  R Grant Steen: “Retractions in the scientific literature: do authors deliberately commit research fraud?”, Journal of Medical Ethics, November 15, 2010, as posted at http://jme.bmj.com/content/early/2010/10/18/jme.2010.038125.abstract

[62] “India, US top science fraud list”, The Telegraph, Calcutta, India, November 15, 2010, http://www.telegraphindia.com/1101130/jsp/nation/story_13238575.jsp  

[64]  Michael Shermer: “Financial Flimflam: Why economic experts’ predictions fail”, Scientific American, March 2011, page 77

 

 
 

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