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and a documentation of   patient-harming frauds in medical research

 

 

 
Footnotes:

 

22 W.R. Hepner, C. Krause, and M.E. Davis: "Retrolental Fibroplasia and Light", see pages 825 and 826 for the patching delays in each case report: "8 hours", "30 hours", "30 hours", "on the first day", and "24 hours".

 

 

 

23 John C. Locke and Algernon B. Reese: "Retrolental Fibroplasia: The Negative Role of Light, Mydriatics, and the Ophthalmoscopic Examination in its Etiology", Archives of Ophthalmology, #48, 1952, pages 44 to 47, see page 45, line 7 after the subtitle: "Monocular occlusion"

 

 

 

24 A. Fulton, I. Abramov, J. Allen, J. Gwiazda, L. Hainline, J. O'Neill, P. Raymond, and D. Varner: "Optical Radiation Effects on Visual Development", pages 137 to 146 in Waxler M. and Hitchins VM, eds.: "Optical Radiation and Visual Health", CRC Press, Boca Raton, Florida, 1986; see page 142 top.

 

 

 

25 A.L. Exline, Jr., and M.R. Harrington: "Retrolental Fibroplasia: Clinical Statistics from the Premature Center of the Charity Hospital of Louisiana at New Orleans", The Journal of Pediatrics, Vol. 38, No.1, January, 1951, pages 1 to 7.

 

 

 

26 Jeffrey P. Baker: "The Machine in the Nursery -- Incubator Technology and the Origins of Newborn Intensive Care", The Johns Hopkins University Press, Baltimore, 1996, pages as cited.

 

 

 

27 Zacharias L. Retrolental fibroplasia: a survey. Am J Ophthalmol 1952: 35: 1426-54, see page 1431 bottom right and 1432 top left.

 

 

 

28 Palmer EA, Flynn JT, Hardy RJ, Phelps DL, Phillips CL, Schaffer DB, Tung B. Incidence and Early Course of Retinopathy of Prematurity, Ophthalmology, November 1991, 98: 11: 1628-1640.

 

 

 
Footnotes:

 


 


 

  

 

  

  Rigged studies in preemie treatment

 

and their continuing cover-up 

 
 

Davidpreem01.jpg (20108 bytes)

Frauds, cover-ups, and other ethics violations in medical studies of preemies 
by H. Peter Aleff

 You are on page

1    2    3    4    5    6    7    8    9

My letter to Dr. Feinstein, continued from page 3
Part 2. The role of light
in the baby-blinding epidemic

Besides killing thousands upon thousands of babies and inflicting irreversible brain damage on many others, this failure of the medical community to acknowledge and thus end its doctrine- enshrined euthanasia program also prevents said community from addressing or even admitting the real reasons for the eye damage that the misguided oxygen rationing is supposed to prevent.

You will find in Section 1 of my book a detailed documentation that the typical intensive care nursery lighting recommended by the American Academy of Pediatrics exposes the premature babies in those nurseries in 15 minutes or less to the US industrial safety regulations' danger-limit dose of retinal irradiation for adults, and that all the clinical studies which claimed to "conclusively prove" the lack of ROP difference between babies exposed to nursery lighting and those protected from it applied the alleged protection much too late to prevent the damage.

Revisiting some purported counter-examples:

1.) Delays in eye patching

This includes the two studies you cite on page 1272 left of your "autopsy" as having refuted the accusation against light. It may be understandable that you considered their patching times as "almost immediately after birth" before you related this timing to the speed with which light damage occurs. However, the authors of those studies did not patch the eyes of the babies in their experiments "almost immediately after birth" but report delays that were much too long to let the babies escape the retinal damage against which the industrial safety guidelines warn for adults exposed to such high retinal irradiance accumulations.

Hepner et al.22 write in their 1949 study the delays ranged from "a few hours" to up to 30 hours; furthermore, their "cotton pads held in place by surgical stocking" are neither likely to have stayed always in place nor to have provided much opacity.

Locke and Reese state similarly on their page 45 that they applied the patches "within the first 24 hours"23. Theirs was a catch-all study, hastily performed for publication in 1952 to dispose of alternatives to the oxygen myth they prepared, and they claimed to "conclusively" demonstrate "The Negative Role of Light, Mydriatics, and the Ophthalmoscopic Examination" as factors in the blinding.

You may evaluate those authors' concern for careful research from their claim that their gauze patches "shut out all light"; actual measurements of such patches show that "gauze pads [have] about 20% transmittance, well applied"24.

Both those studies were thus fatally flawed, unscientific, and highly misleading, and neither of them can be claimed to have ruled out the role of light in the blinding.

2.) The Charity Hospital in New Orleans that did not fit the oxygen theory

You also mention on page 1275 right of the "autopsy" the puzzling case of the New Orleans Charity Hospital25 "where high-dose oxygen had been used abundantly" without producing any instances of the eye damage. On pages 1276 and 1282 you then cite Dr. Gordon's "attractive explanation" of why he thought that report was erroneous: the incubators were "opened widely to care for the infants" and the oxygen concentrations were not directly measured but only the inflow. 

However, these conditions applied just as much to many of the other hospitals at that time and are no valid reason for excluding the inconvenient Charity data that do not fit the oxygen myth. You warn on page 53 of your Santayana essays that

"Once established, an erroneous paradigm for etiology or therapy is difficult to dislodge, and may lead to deluded interpretations of correct evidence." and that "In many instances, the investigators who hold firm beliefs about a particular etiologic hypothesis will ignore the 'confounders' that may be actually responsible for the observed distinctions."

So why would you allow that Dr. Gordon to get away with what you condemn in your essays?

On the other hand, said Charity report states on page 4, right, in the January 1951 issue of Pediatrics, that "after admission, infants were usually kept in closed incubators until a weight of about 1,800 grams was attained". These closed incubators could have protected the babies from the fluorescent ceiling lights in that nursery.

The first Chapple- type incubators with transparent acrylic tops had just been introduced at that time, but Charity Hospital used the older Gordon Armstrong, Model X-4, as footnoted on that page 4.

I have not seen this model but expect it was likely to have featured an opaque top with only a small viewing port, like all the other pre-Chapple incubators of which I have seen pictures, particularly since the report called it "closed". Do you have access to an illustration of that Gordon Armstrong model X-4 so we could verify this?

More on incubators: Jeffrey P. Baker mentions in his book "The Machine in the Nursery"26  that "the Hess beds, incidentally, escaped the retrolental fibroplasia epidemic, presumably because they were not airtight" (page 232). On page 173 he describes these beds:

"... it was Julius Hess who first transformed the incubator into an oxygen chamber.  He did so, in 1934, by creating a metal hood with a small window designed to be fitted over the incubator bed. (...) [This device] did represent a significant innovation in maintaining a constant elevated pressure of oxygen around the infant. (...) [It] made observation of the baby difficult and could not maintain a high oxygen concentration.  Yet, it did produce superior results and helped ignite a wave of enthusiasm for oxygen therapy that would lead to much more elegant incubators capable of delivering oxygen concentrations close to 100 percent."

That presumed lack of airtightness in the incubators cannot be credited with having protected the babies from the blinding. You note on your page 1280, as I do on my pages 30 and 31, that even the 1953/54 Cooperative Study had specifically exonerated variations in the concentrations of oxygen administered to the infants and had incriminated only the length of time during which they received supplemental oxygen of whatever concentration.

Furthermore, there is no reason why the covered-metal-tub bed described and shown could not have maintained almost any desired oxygen concentration: a baby incubator is not a pressure vessel where a small leak will noticeably affect the inside pressure. The atmosphere around the baby is at ambient pressure so that the oxygen escapes not as some high-speed jet through the small openings but only by relatively slow diffusion into the surrounding air.

In any case, the oxygen concentrations achieved despite all the postulated leaks were clearly high enough to produce the "superior results" that helped the babies to survive, and those sufficiently high concentrations did not damage their eyes.

Dr. Baker's argument that the babies in the Hess beds escaped the blinding because the incubators were not airtight does thus not hold water either. It is just a symptom of the Santayana Syndrome: the medical custom to explain away inconvenient "confounders" with contrived arguments.

Hessincubator.jpg (25745 bytes)

On the other hand, the attached photo of a Hess bed from Baker's page 170 shows an opaque metal top and a

lampshade-like fabric hood over the small opening in the head end of that top. This bed offered much better protection from light than most preemies are granted today, and it is an obvious as well as sufficient explanation why the babies in its safe and soothing shade incurred no light damage to their eyes.

Please note also that 80 per cent of the preemies at Charity were black (Charity page 7, left), and that the pigmented eyelids of black babies offer them more protection against light than the almost transparent ones of white infants.

Dr. Leona Zacharias had already drawn attention to this lower incidence of ROP among black babies in her 1952 survey27 of what was known about the disease, and the nursery doctors involved in the cryotherapy study rediscovered that same fact almost 40 years later as an "unexpected outcome"28.

This highlights a serious obstacle to your proposed cure for the Santayana Syndrome: how can one expect these nursery doctors to learn from the history of medicine when they cannot even remember the history of their own narrow sub- specialty?

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