December 28

1953–1954: Multi-Site NIH Cooperative Study of Premature Babies’ Survival

NIH Multi-Site Cooperative Study of Retrolental Fibroplasia (RLF, later called, ROP), a form of blindness in premature babies was conducted at 18 hospitals nationwide. The first recorded case of RLF in a premature baby was in 1942 in Boston, decades after premature babies had been routinely provided unrestricted oxygen during their first weeks of life. The NIH Cooperative Study was touted as a state of the art “scientific” double-blind randomized experiment which its authoritative promoters claimed; they had proven that by restricting oxygen to 40%, they prevented blindness in premature infants.

The experimental design required that all 1,420 premature babies at 18 participating hospitals would be deprived of life-sustaining oxygen for 48 hours after birth — as a result, 634 of these fragile babies (45%) died. That high death rate is alarming when compared to the 32% death rate documented at a Cooperative Study participating hospital in New York one year before the Cooperative Study began. (Silverman and colleagues, among them, Dr. Algernon Reese, Archives of Ophthalmology, 1952) The NIH Cooperative Study sacrificed the lives of 161 babies.

The surviving 786 infants in the NIH Cooperative Study were randomized; half received restricted oxygen and half received standard care — i.e., unrestricted oxygen for three months; thereafter they too received restricted oxygen, regardless of their clinical need. The conflating of the two groups fundamentally undermined the scientific integrity of the study which was no longer a “controlled, double-blind” study. The conflating eroded the basis for the published claimed findings rendering that report fraudulent. Furthermore, the researchers failed to report the deaths of 634 babies who had been denied oxygen for 48 hours. In their published report, they disclosed the results of only 786 infants who survived the first 48 hours; and claimed success at preventing ROP without an effect on the infants’ survival rate.

The misleading claims about the results of this defective study were highly influential in establishing rigidly restricted oxygen practice standards at intensive care units for premature babies for many decades resulting in an estimated 150,000 deaths in the first two decades. The experiment was grossly unethical; it was designed in the knowledge that withholding oxygen from very fragile premature infants during the first 48 hours after birth would increase the number of deaths. The researchers’ callous disregard for the life of these infants is further demonstrated by their failure to report the deaths of 634 babies in their published report. The prominent NIH researchers who designed and conducted the experiment misrepresented entirely the true results of the experiment; they committed fraud. Dr. William Silverman, a prominent neonatologist, who had advocated for a controlled study, in hindsight, acknowledged that “the weak design led to problems that plague the field to the present day:

“Why were they enrolled in 48 hours, I questioned for 40 years or more. This has been driving us crazy. Was it that mortality in those days was very high, and most of the burden of mortality was in the first 2 days? It was decided that they should be enrolled at age 48 hours. Well, this came back to plague us, as you can imagine.” (Oral History Interview, William Silverman, MD. American Academy of Pediatrics, 1997)

And Dr. Silverman acknowledged that the theory blaming oxygen as the single cause for premature infant blindness is “largely in doubt,” calling it “dogmatic slumber” (“Oxygen Dogma Challenged” in the Archives of Disease in Childhood, 1982).

Peter Aleff, who has studied the ROP literature in depth, and whose website contains the most comprehensive documentation about this issue, argues that the NIH Cooperative Study design betrays the eugenics mind-set among neonatologists who were convinced that ROP was due to a prenatal genetic “defect” and that babies were “better-dead-than-blind.” In his article, Deceptive ROP Research Peter Aleff writes,

“. . . blindness had been a favorite target of eugenicists[i] whose pseudo-science dominated medical thinking to the point that most U.S. states passed medically inspired sterilization laws to keep the “undesirables” from contaminating the gene pool. And some of the most influential American ophthalmologists at the time believed that ROP was caused by “defective germ plasm”. One of them, Dr. Algernon B. Reese, wrote a series of learned-looking papers to assert the allegedly prenatal origin of the eye damage. He presented the latest of these at the June 23, 1948, meeting of the American Medical Association’s Section on Ophthalmology where he and his like-minded colleagues recommended that the best way to deal with the epidemic was to “not be so zealous in preserving defective persons, of which the world has a sufficient quantity already”. [Emphasis Added] (Abstract of Discussion Following presentation by Algernon Reese: Persistence and Hyperplasia of Primary Vitreous; Retrolental Fibroplasia in Archives of Ophthalmology, May 1949, pp. 527–550)

One year after the Doctors Trial at Nuremberg, when the world learned about the unspeakable but real medical atrocities committed by leading German doctors, leading American physicians were promoting infanticide! Read about the incredible suffering and brain damage that insufficient oxygen causes:

Under the continued oxygen starving regime, those preemies who do not die of asphyxiation can breathe only in agony, and many of them suffer permanent harm from it. That harm takes multiple forms, often in the same patient. The resistance of oxygen-deprived babies is diminished and their recovery delayed, their mental development is frequently stunted, and they are more likely to have physical handicaps. For instance, a British study of more than 1000 ex-preemies found in 1962 that denying them supplementary oxygen during their first few days had quadrupled the incidence among them of spastic diplegia, a form of cerebral palsy, from 5% for those with 10 or more days in oxygen to 20% for those with fewer or none. (Silverman, 1980)

Furthermore, other severe brain damage must be expected in people whose brains suffered even briefly from lack of sufficient oxygenation. This damage usually develops later than the short timeframes of the typical hit-and-run clinical studies, so this additional toll in physical and mental damage from the “better-dead-than-blind” therapy remains largely the hidden part of the iceberg.”

Despite overwhelming evidence that restricting oxygen from extremely fragile premature babies kills them, the NIH sponsored a multi-site SUPPORT oxygen study, another medical atrocity in which extremely premature infants were restricted in the amount of oxygen they were given. The foreseeable result was documented in “extra” deaths. Read more *

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