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Footnotes:

 

 

19 This 1897 report by a Dr. DeLee is quoted in Jeffrey P. Baker's "The Machine in the Nursery", op. cit., on page 119. The two diagrams of preemie incubators are published in the same book, pages 72 and 83, and credited to "Transactions of the American Pediatric Society 5 (1893).

 

 

 

20 Algernon B. Reese: Opening Remarks of the Moderator for the September 1954 Symposium on Retrolental Fibroplasia, op. cit., page 7.

 

 

 

21 As an update to that story about the mother who had to wage a two-year campaign in the mid-1980s to have the nursery doctors admit babies feel pain and should not be vivisected without anesthesia as was then the barbarian custom, a recent study of circumcision suffering just published in JAMA found that some physicians still believe newborns neither feel nor remember pain, as reported in the Philadelphia Inquirer on 12-25-97 under the title: "New study supports use of anesthetics in circumcisions".

 


 


 

  

 

  

  
 

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

 You are on page

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My letter to Dr. Feinstein, continued from page 2
The nursery doctors around Reese 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 gas could therefore not be blamed for the never previously encountered blinding. 

See pages 21 and 40 of my book for some examples of pre-ROP routine oxygen supplementation which document that the administration of therapeutic oxygen had not "recently become used routinely in the premature newborn nursery", as you state on page 1268 right, bottom, of your "autopsy", but that it had been long been used as a matter of course since it was such a clearly beneficial life-saver.

You say there also that "as early as 1945, oxygen administration had become recommended for all premature infants, and its prophylactic usage had been credited in part for a decrease in neonatal mortality".  However, the routine of administering oxygen to preemies and the experience of saving their lives with it was much older

Already a 1897 medical report mentions continuous administration of pure oxygen as one of the routine resuscitation techniques for 

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preemies19, and the attached diagrams of preemie incubators from the 1893 "Transactions of the American Pediatric Society" both already show items labeled "connection for oxygen supply" and "oxygen pipe".

Oxyincubator2.jpg (42271 bytes)

That is 47 years before the first baby ever suffered from ROP, and 61 years before Reese and his like-minded colleagues suddenly declared the then decades-old habit of giving oxygen to be the culprit for the then recent epidemic of preemie-blinding.

The eye damage had burst onto the scene only in 1940, together with the introduction of fluorescent lamps in America, and in Europe shortly after the war when these lamps became available there, too (See pages 1 to 4 in my book).

Even retrospective studies among older blind people could find no cases of retrolental fibroplasia in people born before then, so there was no logically defensible way how this entirely new condition could suddenly have been caused by the long familiar and regularly administered oxygen.

The correlation with the fluorescent lamps is clear and was repeated, whereas that with the oxygen administration does just as clearly not exist and is a post-hoc contrivance that bends the data to fit the bogus theory.  Your Santayana Syndrome prescription for how the medical profession should use history is to learn from it, not to reinvent it to suit the profession's needs.

However, the oxygen helped the most immature babies to survive, and those were the ones most at risk to wind up blind. The study designers knew that withholding this life-saving gas would reduce the number of children who might require facilities for the blind. Accordingly, they refused the usual supplementary oxygen for the first two days of life to virtually all the babies who arrived in the trial hospitals.

This ruthless pre-enrollment weeding of the babies killed off those infants with the most immature lungs who were also those with the most immature eyes and thus most at risk for ROP; it thereby allowed the nursery doctors to falsely claim that the oxygen rationing had not affected the mortality rate of the babies but had greatly reduced the number of those affected by ROP.

You cite on page 1280 of your "autopsy" the study report that 45% of the eligible infants died during these first 48 hours without supplementary oxygen so that the trial included only the surviving half of the population at risk, and you point out this so clearly biased sample should not have been used for deciding to curtail all use of oxygen, even in the first 48 hours.

You also state that the oxygen rationing introduced by that trial increased the mortality among the so deprived babies, and that a later attempt to replicate the study results found the blinding "had no distinct association with arterial oxygen concentrations and no correlation with administered oxygen concentration, except at very high concentrations of much over 80%".

You are thus aware that the sample was cooked, and also of this further hallmark of "pathological science", as you call it on Santayana page 54, that the attempts to retroactively justify the so suddenly adopted and experience-discarding doctrine derived from the initial trial all failed to reproduce the alleged result.

Yet, on Santayana page 74 you repeat the official medical myth that the initial study had "unequivocally demonstrated [the toxic effects of oxygen] in a suitably randomized trial". Are your admonitions on Santayana pages 78/79 to avoid "complacent tolerance of contradictions" then meant only for others?

The continuation of the medical infanticide

This kangaroo-court condemnation of innocent oxygen was camouflaged behind the mammoth show-trial and announced with great fanfare plus the combined authority of many sesquipedalian-titled medical experts, "not as a series of papers expressing individual views" but as the "concerted appraisal of a qualified team"20.

The ex cathedra authority of this trial-backed consensus of the gurus caused neonatologists all over America and around the world to immediately and severely curtail all supplementary oxygen for premature babies.

Over the years that followed, many tens and possibly hundreds of thousands of the weakest among those babies died of this misguided asphyxiation, or rather of physician-caused "fate", exactly as proposed a few years earlier in Dr. Payne's discussion of Dr. Reese's speech, and as then cynically implemented by those few who shared their views and helped to dupe all the others.

Although the oxygen restrictions are less severe now, many babies still die of that "fate".  For instance, a mid-1980s study found a 94% probability that the extra deaths in the group with less oxygen were due to this difference in breathing assistance (see my pages 35 and 36).

However, with the lack of concern for the patients that is unfortunately so common in intensive care nurseries that doctors routinely operated on babies without anaesthesia (see pages 144 and 145 in my book, and note 21 here), the physicians involved simply dismissed that strong risk as not significant.

They should have told the parents honestly that there were 16 chances out of 17 that their baby's risk of dying would increase from the oxygen withholding, and that there was no demonstrable practical or even theoretical benefit whatsoever to expect from this drastic increase in danger.

Indeed, neonatologists admit among themselves the futility of even trying to describe an arterial oxygen tension in the retinal vessels, or to relate the oxygen they measure in the peripheral vessels in any way to the eye damage (pages 35 to 39 and 235 in my book).

They are groping in the dark to the point that some of them are even testing if a slight relaxation of the rationing might improve the babies' eyes instead of damaging them.  Yet, many nursery doctors, duped by their fatally falsified but blindly believed doctrine about the real reasons behind the oxygen rationing, still follow unwittingly and uncritically the fossilized instructions from the now decades-old medical euthanasia program against "weaklings" and potential "defectives".

[Note added in 2002:  The misguided but convenient theory of genetic defects to be blamed for the baby- blinding is back.  

A group of "concerned physicians and volunteers" put up a website to raise funds for their "pediatric retinal rescue lab" and for "further genetic research" into this baby-blinding disease. 

They claim  at ropard.org/history/shtml that their "research has begun to identify a genetic link between premature birth and retinal detachment".  They offer no evidence, and that self- serving bogus theory behind the first of the frauds described in this series has still no basis in fact, but it continues to help in hiding the medical responsibility for the baby- blinding epidemic and its baby- killing cure.]

If engineers used only this medical grade of rigor in their analysis of failures like that of the Tacoma Bridge, or of the possible malfunctions in aircraft crashes, you would neither want to drive over a bridge nor entrust your life to an airplane.  Should medical doctors not be held to the same standards of reasoning as engineers and other trustworthy professionals?

Continue reading2. The role of light in the baby-blinding epidemic

  

 
 

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