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Footnotes:

 

 

1 Alvan R. Feinstein: "The Santayana Syndrome I: Errors in getting and interpreting evidence", and "The Santayana Syndrome II: Problems in Reasoning and Learning about Error", Perspectives in Biology and Medicine, 41, 1, Autumn 1997, pages 45 to 57 and 73 to 85.

 

2 Robert M. Jacobson and Alvan R. Feinstein: "Oxygen as a Cause of Blindness in Premature Infants: 'Autopsy' of a Decade of Errors in Clinical Epidemiological Research", J Clin Epidemiol, Vol. 45, No. 11, 1992, pages 1265 to 1287.

 

3 Kinsey EV.: Cooperative Study of Retrolental Fibroplasia and the Use of Oxygen, AMA Archives of Ophthalmology, 1956, 56: pages 481 to 543.

 

4 Who's Who in America 1982-83, entry for Reese, Algernon Beverly. The 1984-85 edition no longer lists him.

 

5 Transactions of the American Academy of Ophthalmology and Otolaryngology, January/February 1955, unnumbered opening pages.

 

6 "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.


 


 

  

 

  

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 premature babies 
by H. Peter Aleff

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The material in this series of web pages describes and documents

  • first a callous deception by a few eugenics-minded medical leaders in the 1950s.  They rigged a study to establish the restrictions of oxygen supplementation for premature babies as a killing cure for the epidemic of baby- blinding from retinopathy of prematurity.  Then

  • the fraudulent study design of the 1995 to 1998 LIGHT-ROP study which was rigged to falsely exonerate nursery lighting as cause of the continued blinding.

You will also find here a summary of the medical cover-up for these self- serving frauds that stain the name of science, and links to the relevant parts of the book which give further details. 

I wrote this account in response to a particularly unctuous article in a medical journal about the medical profession's need to learn from its errors.  That article was authored by a physician who had found much fault with the earliest attempts to study retinopathy of prematurity but willfully ignored the much greater errors and outright frauds which marred the later alleged solution. 

Here is the reply I sent on January 7, 1998, to

Professor Alvan R. Feinstein, at the Department of Medicine and Epidemiology,
Yale University School of Medicine,

P.O. Box 208025, New Haven, CT 06520. 
The Post Office gave me a return receipt showing that he received the letter, but he never replied. 

I posted my comments therefore here as an open letter to him and to his medical colleagues, and also to the institutions that condone the patient- harming behavior and hypocrisy exposed below:

Dear Professor Feinstein:

I read with great interest your two essays in the current issue of Perspectives in Biology and Medicine about what you dubbed the Santayana Syndrome1 -- the persistent failure of the medical profession to learn from its long history of wrong ideas and patient-harming errors. Please accept my congratulations for your courage in publishing this critique of some flagrant flaws in the medical doctrine and of the unsound epistemological basis for many now widely accepted medical practices.

You say that the Santayana Syndrome occurs when past errors are repeated because they were inadequately identified, taught, or learned, and you present as one of your prime exhibits what you call on page 74 "perhaps the most obvious iatrogenic harm of the 20th century", the baby-blinding epidemic of retrolental fibroplasia.

I want therefore to bring to your attention that this still continuing epidemic, now known as retinopathy of prematurity (ROP), is a far more damaging manifestation of that Santayana Syndrome than even you have so far identified: the medical failure to face up to this problem continues to blind, maim, and even kill up to several thousand premature babies each year, in this country and around the world.

When Dr. Jacobson and you performed your "intellectual autopsy" of the first decade of errors in the medical approach to this epidemic2, you limited your analysis unfortunately to the initial blunders and then simply accepted the official medical doctrine that the blinding had been due to high-dose oxygen therapy. Had you continued your research to include the reasons for that doctrine, you would not have said, as you do on page 74 of your Santayana article, that the toxic effects of oxygen "were unequivocally demonstrated in a suitable randomized trial".

Part 1. The alleged role of oxygen
in the baby-blinding epidemic

Your limited analysis was like an archaeological test trench that stops short of the most vital clue to the site by a mere few inches. Had you dug just a little farther, you would have discovered that said oxygen trial3 was unequivocally biased instead and crucially misleading, a worse ethics violation than even the infamous medical Human Radiation Experiments which recently revealed the patient-abusing medical attitudes of that time, and that it was moreover a scientific fraud, rigged to produce an intentionally false and still patient-harming result.

In strata right next to your trench that are now nearly half a century old, you would have found a still smoking gun: prominently published evidence that the at least outwardly unanimous group of leading physicians who planned and executed this trial included advocates of ruthless Nazi-style eugenics who openly proposed to eliminate the babies at risk as "defective persons of which this world has a sufficient quantity already".

Adding this piece of evidence makes the rest of the puzzle fall together, so you would have recognized that this old gun is still shooting and killing: the doctrine instituted by that trial, the still current practice of oxygen rationing for premature babies desperately in need of this breathing help, is in fact the survival of an unacknowledged euthanasia program.

This program is so well disguised and thus remains so unchallenged that it was and still is able to continue far longer than its infamous forerunner and model in Germany, and to accumulate even more victims.

Once you study the full evidence available about that trial, you will find it hard to avoid the conclusion that these 1950s physicians planned their oxygen withholding trial as a cynical means to reduce the number of blind children by not allowing those most at risk to survive.

You will see that the American doctors who created this elimination program against the "defectives" in their nurseries did so along the lines of the very similar program which their German colleagues had initiated and executed not long before against the "defectives" of all ages in their institutions.

The only differences, besides the lower ages and higher numbers of the victims here, were that the American eugenics- advocating doctors concealed their systematic killing much better than their German counterparts, and that instead of killing the "defectives" with life-destroying poison gas they killed them by Tuskeegee- style withholding of the known remedy, the indispensable life- saving gas.

If you had extended your investigation to then cover the hidden mass infanticide that nursery doctors in America and around the world performed in the wake of that bogus study, most of them unknowingly, you would have been shocked how easily this so fraudulently created oxygen rationing doctrine mislead even those many physicians who would never have knowingly agreed to asphyxiate babies just to prevent them from growing up blind.

You would then probably have commented in your Santayana papers on how this pathological gullibility of doctors "rendered immune [to skeptical thinking] by modern medical education" (to use some of your words from page 82) took and still takes a high death toll among the targeted babies, and how this "failure to anticipate the adverse effects of well-intentioned actions" (your page 73) now prevents said doctors from addressing the real and abundantly documented iatrogenic cause for the blinding.

I also trust that you would have been appalled by the dishonest denial and deliberate falsification of data (of the type that you rightly brand on page 54 as "shameful" and "egregious exceptions to scientific behavior") with which some leading physicians and highly placed medical officials tried and are presently trying to cover up this still ongoing crime, as described farther below.

Preparations for
the show-trial of innocent oxygen:

As a summary of the documentation for this acute and severe case of Santayana Syndrome you will find enclosed a copy of my book "The Medical Ethics Trap behind Retinopathy of Prematurity and much Cerebral Palsy".  Section 2 of that book on pages 21 to 49 (posted here as the "Oxygen withholding" series) contains my detailed description of the oxygen starving practices and of the fraud and other ethics violations in the experiment on which they are based.

I am further attaching some additional evidence, bound with this letter behind the colored sheet that lists these attachments.

The first of these items, the smoking gun which I discovered after putting together the book, is the "Abstract of Discussion" that followed the reading of a lengthy technical paper on the clinical development of retrolental fibroplasia by Dr. Algernon B. Reese before the June 23, 1948, meeting of the American Medical Association's Section on Ophthalmology.

Reese was then a powerful medical opinion leader, consulting ophthalmologist to many major hospitals in the New York area, frequent honor lecturer, recipient of assorted distinguished awards and medals, past chairman of the Eye Sections at both the New York Academy of Medicine and the New York State and County Medical Society, President-elect of the New York Ophthalmological Society4, a few years later also President of the American Academy of Ophthalmology and Otolaryngology as well as chairman of its Executive Committee on Research and Finance and of its Judicial Committee5.

At the time Reese read that paper, he was moreover the editor of the American Medical Association's "Archives of Ophthalmology" where he published said paper and its above cited discussion in May 1949.  He was also a prolific and highly prejudiced writer on ROP who persistently asserted as fact his even then unsupported (and meanwhile long disproven) assumption that this postnatal eye disease had a prenatal and congenital origin.

The physician whose words this Abstract gives had been asked to discuss Reese's just presented paper. This Dr. Brittain F. Payne from New York can thus be deemed to have shared its author's and discussion editor's views even if the latter did not want to state these patently anti-Hippocratic views himself but preferred to keep his advocacy of them deniable.

Dr. Payne blamed defective germ plasm as playing an important role in the etiology of the eye damage and then proposed openly to solve the problem by not preserving the "defective persons" at risk for it.  Here is how he concluded his written rendering of that discussion [emphasis added]:

"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."6

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