retinopathy of prematurity.org
Baby-harming medical research
about retinopathy of prematurity
by H. Peter Aleff, 2005 to 2009
2.6: Proclaimed results of the bogus oxygen study
Despite the fraud in the risk-weighing, 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. They also showed that the severity of the damage was unrelated to the length of exposure to supplemental oxygen.
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.
Of course, that bogus study was successful in that it led to exactly the euthanasia program its sponsors had designed it to produce. However, in clinical terms, all it 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, and it 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.
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.
Three of Reese's medals came from the fund established at the University of Buffalo to honor Dr. Lucien Howe. This was probably not by coincidence because the bogus study which Reese had led to launch was clearly designed to apply Howe's then still covertly acclaimed blindness-targeting eugenicist ideas.
The plainly fake oxygen study met therefore with uncritical acceptance among the eye researchers who had absorbed those ideas as part of their medical curriculum, including the training most of them had received at Harvard's eugenics-tainted Howe Labs.
That bogus study's openly biased verdict against life-saving oxygen is now a cornerstone of the intensive care nursery industry's intellectual foundation, and its still followed recommendation for oxygen rationing has affected the daily life in intensive care nurseries around the world probably more than any other single study ever did.
It is, of course, a naïve violation of the most basic scientific procedures to disregard all previous evidence and to accept a single new contradictory finding without further evaluation. Yet, the entire oxygen rationing policy that forms the core of modern American-style neonatologist theory and practice throughout the world is based on this one single and patently rigged trial that contradicted many decades of previous positive experience with oxygen and that could never be duplicated or confirmed despite several attempts to do so.
Even before the final report on that bogus study's dressed-up non-findings was printed, many neonatologists began to institute policies of limiting preemies’ oxygen supplements to emergency situations, and even then only in concentrations of not more than 40 per cent. This was an arbitrary number not based on any trial findings but only on the personal belief of a few physicians at the Bellevue Hospital in New York[6,7].
The compiler of the Cooperative Study report warned in a letter to the editor of Pediatrics against this unwarranted conclusion. But his warning did not stop a nursery doctors’ stampede towards this arbitrary and unjustifiable 40 per cent limit as the easy final solution for seeing less babies blinded by ROP leave the nurseries.
Once the new medical prejudice against oxygen had been announced, the American adversarial legal system virtually guaranteed its full enforcement. The authoritative and much publicized condemnation of this gas as the alleged cause of the nursery blinding led quickly to many malpractice suits alleging its improper use. Parents were much more likely to sue over a baby's blindness than over his death, and behind every nurse who wanted to open an oxygen faucet to help a struggling preemie breathe for survival stood the specter of a lawyer who would pounce on her if that child happened to wind up blind.
2.7: Initial death toll from the bogus oxygen study
Many of those neonatologists who observed their patients and kept up with their outcomes must soon have become aware of the mass dying their alleged prevention measure caused. But only one raised a question about it in print.
Silverman recounts in his chronicle of the bogus oxygen trial's aftermath that in 1957, the year after the final report about the Cooperative Study had been published, a Dr. Harry Gordon pointed out in a letter to Pediatrics that the 48-hour delay before helping the babies to breathe may have produced a misleading conclusion about oxygen withholding allegedly not affecting mortality. There were no replies to this timid suggestion although by then, that misleading conclusion was already routinely killing many thousands of preemies every year.
In 1960, two physicians reviewed the autopsy reports at the Johns Hopkins Hospital in Baltimore. They wanted to compare the rates of death from hyaline membrane disease, or breathing problems, among preemies with birth weights between 1000 and 2500 grams born during the five years immediately before the oxygen rationing and the five years after its beginning. They found in their sample that the death rate from hyaline membrane disease – or breathing problems -- had more than doubled, and that the sudden increase in this single cause had raised the overall mortality among those babies from 8% before the oxygen withholding doctrine to 13% after its introduction.
Their comparison covered 1152 "before" and 1492 "after" autopsy reports at one hospital. Extrapolations from such relatively small groups can be unreliable because the sample may not be representative. However, in this case, all the intensive care nurseries from coast to coast followed essentially similar rigorous oxygen policies based on the same suddenly introduced and much publicized strict withholding recommendations.
It seems therefore probable that the effects of these similar policies were also somewhat similar, so an extrapolation can provide at least a clue to the order of magnitude for the mass dying from the respiratory distress epidemic. Projecting this 5% increase in mortality in and around Baltimore onto the about 315,000 babies born nationwide in 1960 with birth weights below 2500 grams yields an estimate of roughly 16,000 extra deaths per year in the U.S. from the oxygen withholding during its first five years.
Babies with birth weights below 1000 grams were not included in the Baltimore review but are even more likely to have died from lack of oxygen. The true death toll was therefore probably much higher. For comparison, in the years before the oxygen throttling, ROP had severely impaired the vision of at most up to 2,000 babies per year in the United States and totally blinded less than 1,000 among these.
Two British researchers arrived in the early 1970s at surprisingly similar conclusions by an entirely different method. They compared the actual and expected mortality rates on the day of birth and during the first month of life for the periods before and during the oxygen restrictions, and they saw a striking picture emerge.
For several decades, the mortality rates had shown a steadily incremental decline, but at the beginning of the oxygen withholding their graph began to diverge sharply from the projected path. Instead of further diminishing, the annual toll in early deaths suddenly stayed level or even rose. The researchers took the differences between the projected and the reported death rates as related to the oxygen rationing and then divided the so calculated number of extra deaths by the difference in ROP cases before and during the oxygen rationing. By this method, they computed that the practice of oxygen withholding had cost in England and Wales about 16 deaths for each case of blindness prevented.
The United States mortality records plotted in Figure 1 below show a similar distortion in the death rate evolution, parallel to that in England, and consistent with the magnitude of the sudden mass dying that the Baltimore autopsy reviewers and the British death rate comparers had documented.
When the oxygen rationing began, the U.S. infant mortality rates suddenly stagnated and even rose, instead of continuing to decline along the exponential learning curve which they had been following for some time.
For instance, an item on "Infant Mortality" in the July, 1960, issue of Scientific American noted:
"The death rate of US infants, after a long and precipitous decline, has leveled off in the last few years, according to a study by Iwao Moriyama od the National Office of Vital Statistics. In same states it has even risen slightly, after reaching an all-time low of 26 per thousand live births in 1956." 
All the extra babies who died did so on their first day when breathing is hardest and the need for oxygen greatest. Even some of those who would otherwise have died during days two to twenty-eight now died on day one, perhaps escaping the agony of a prolonged and doomed struggle but confirming clearly that this first day had indeed become much more difficult for all the weakest preemies.
You may appreciate the cost in lives from the "suffocation-bulge" in the death rates when you compare the big hump it made in the graph below with the almost invisible impact on those death rates from the much celebrated clinical revolution caused a decade earlier by the arrival of the first antibiotic.
These different but converging lines of evidence suggest thus that during those early and most uncompromising years, the oxygen starvation euthanasia program was steadily slaying more than twice as many Americans per year than the Viet Nam war did at its peak. It also killed each day about twice as many real preemies in America than the 22 fictitious preemies in Kuwait whose alleged deaths inflamed the American public and Congress in 1991 with Gulf War fever and are said to have swayed the war-deciding vote.
However, neither Gordon’s pointing out the fatal flaw in the bogus oxygen withholding study, nor the shocking autopsy review from Baltimore, nor even the quickly rising day-of-birth mortality rates in nurseries from coast to coast, brought about an immediate reversal of the harmful oxygen withholding policies.
nursery doctors must have known this deadly side effect from their
cure for the preemie blinding epidemic, but none of them told the
trusting public until many years later. Even then, those who
admitted the mass dying offered only sanitized versions that avoided
any mention of the euthanasia program behind the oxygen withholding
doctrine, and none acknowledged that the dying is far from
Figure 1: Infant death rates in the U.S. before and after the oxygen withholding study
Figure 1 -- Infant death rates in the U.S. before and after the oxygen withholding study: Top curve = Neonatal deaths within 28 days of birth, 1915 to 1991; longest curve below it = Death rates on day of birth, 1937 to 1969; two shorter lines to its right = Death within first seven days, 1970 and 1980 to 1989. The top curve prior to 1940 is based on five-year averages. As this graph shows, the infant death rates for the day of birth and for the first 28 days followed an exponential decline before the beginning of the oxygen rationing, like many other undistorted learning curves, but then leveled off and even rose. Each unit on the “Deaths per 1000 live births” scale corresponds to between 3000 and 4000 babies who died that year in the entire U.S. 
 Sources of data for Figure 1: Neonatal Mortality Rates 1915-1985 from National Center for Health Statistics, Vital Statistics of the United States, 1985, Mortality, part A, sect. 2, page 1, as reproduced in Meckel RA. Save the Babies: American Public Health Reform and the Prevention of Infant Mortality 1850-1929, Johns Hopkins University Press, Baltimore, 1990, Appendix B, pages 238-9; Neonatal Mortality Rates 1980-1989 and Deaths Within Seven Days 1970 and 1980-1989 from U.S. Bureau of the Census, Statistical Abstract of the United States: 1992 (112th edition), Washington, DC, 1992, see No. 110: Fetal and Infant Deaths, page 80 middle; Neonatal Mortality Rates 1989-1991 from Wegman ME. Annual Summary of Vital Statistics - 1991. Pediatrics, December 1992, 90: 6: 835-845. See page 842, Table 7, with data credited to National Center for Health Statistics; Day-of-Birth Death Rates 1937-1969 from Silverman WA: Retrolental fibroplasia: a modern parable. Grune & Stratton, Inc., New York, 1980, rates scaled from Fig. 9.4. on page 65, originally published by Bolton DPG, Cross KW: Further observations on cost of preventing retrolental fibroplasia. Lancet, 1974, 1: 445-448.
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