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ROP description
Eugenics against oxygen
Slandering oxygen

Oxygen study frauds >>>

Alleged study results
Later deaths
Futility and harm
Fluorescent ROP lamps
Damaging irradiance
Preemie vulnerabilities
Studies of light and ROP
Frauds in LIGHT-ROP
Coverup stonewalling

 

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Macular degeneration
Preemie Pain
Parent Concerns

Re-Tuskegee

Bioethics LIGHT-ROP

Bioethics SUPPORT

Bioethics own violations

Bioethics Consent

Bioethics 1955 Oxygen

Unethical Bioethics 1

Unethical Bioethics 2

Unethical Bioethics 3

Unethical Bioethics 4

Hypocritical Nature

False Medical Denials

Pre-Nuremberg Bioethics

Protect Humans in Research

Avaaz Petition to WHO

 


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Footnotes :
 

[1]  Silverman WA. Retrolental Fibroplasia: a modern parable. Grune & Stratton, New York, 1980, see Chapter 6: "The National Cooperative Study", pages 37-42, particularly pages 37 and 38.

 

[2] Patz A, Hoeck LE, De La Cruz E: Studies on the effect of high oxygen administration in retrolental fibroplasia, American Journal of Ophthalmology, 3:(35), January 1952, pages 1248-1253.

 

[3]  Silverman WA. Retrolental Fibroplasia: a modern parable. Grune & Stratton, New York, 1980, see Chapter 6: "The National Cooperative Study", pages 37-42, particularly pages 37 and 38;  see also Silverman WA. repeating this account in the discussion at the Ross Conference on Family Centered Neonatal Care, Burlington, Vermont, June 27-29, 1992, unpaginated transcript.

 

[4]  Silverman WA. Retrolental fibroplasia: a modern parable. Grune & Stratton, Inc., New York, 1980, Chapter 6: "The National Cooperative Study", 37-42, see page 38 top.

 

[5]  Kinsey EV, Zacharias L. Retrolental Fibroplasia: Incidence in different localities in recent years and a correlation of the incidence with treatment given the infants. JAMA, February 26, 1949, 139: 9: 572-78, quote on page 575 bottom left

 

[6]  Silverman WA, Blodi FC, Locke JC, Day RL, Reese AB. Incidence of retrolental fibroplasia in a New York nursery. Archives of Ophthalmology, 1952, 48: 698-711, quotes on page 701 bottom, page 703 bottom, and page 709 middle; for incidence comments, see pages 702 bottom and 704 top.

 

[7]  Dancis J, Lewis JM, Guy LP. Retrolental Fibroplasia: A statistical study with particular reference to the effect of vitamin A. New Engl J Med, September 13, 1951, 245: 11: 402-406, see page 406 top right and bottom left

 

[8]  Litchfield HR, Dembo LH, editors: Therapeutics of Infancy and Childhood. F. A. Davis Company, Philadelphia, 1942, see page 387, Chapter on Congenital Atelectasis, and page 416 top, in chapter on "Feeding the Premature"

 

[9]  Cartwright EW. Infant Survival in Prematurity. California Medicine, May 1954, 50: 5: 398-402, see page 401 right, middle:

 

[10]  Kinsey EV. Cooperative Study of Retrolental Fibroplasia and the Use of Oxygen. Archives of Ophthalmology, 1956, 56: 481-543, see Table 8A on last, unnumbered, page of  Appendix.

 

[11]  Silverman WA, Blodi FC, Locke JC, Day RL, Reese AB: “Incidence of retrolental fibroplasia in a New York nursery”, Archives of Ophthalmology, 1952, 48:698-711, see page 698 for admissions, birth weight, and mortality.

 

[12]   Algernon B. Reese: opening remarks in discussion after Norman Ashton: “Animal Experiments in Retrolental Fibroplasia”, presented in October 1953 and published in Transactions of the American Academy of Ophthalmology and Otolaryngology, January/February 1954, pages 51 to 54, quote on page 54 left, middle.

 

[13]   Symposium: “Retrolental Fibroplasia”, presented at the Fifty-Ninth Annual Session of the American Academy of Ophthalmology and Otolaryngology, September 19-24, 1954, New York, published in the “Transactions” of that Academy, January-February 1955, Volume 59, No. 1, pages 7 to 41; see Reese’s remarks on pages 7 and 39.

 

[14]  Algernon B. Reese, Frederick C. Blodi, and John C. Locke: “The Pathology of early Retrolental Fibroplasia”, American Journal of Ophthalmology, October 1952, Volume 35, No. 10, pages 1407 to 1426. See page 1425, right, for quote.

 

[15]  Weatherall DJ, Ledingham JGG, Warrell DA., eds. Oxford Textbook of Medicine, 2nd ed. 1987, Oxford University Press, Volume 1, page 3.15 bottom left

 

[16]  Annas GJ and Grodin MA. The Nazi Doctors and the Nuremberg Code - Human Rights in Human Experimentation, Oxford University Press, New York, 1992  page 2.

 

[17]  Nolan JR, Connolly MJ, eds. Black's Law Dictionary, Fifth Edition, West Publishing Co., St. Paul, Minnesota, 1979, page 701 left, "Informed Consent" entry near bottom.

 

[18]  Munson R. Intervention and Reflection - Basic Issues in Medical Ethics, Wadsworth Publishing Company, Belmont, California, 1979, page 230 bottom and 231 top.  The purpose of that syphilis study was  that physicians could observe the natural course of the disease.  At least forty of these deliberately uninformed and untreated syphilis sufferers died as a result of factors connected with their disease.

 

[19]  Maurer M. Reflecting the Flame. 1991 National Convention Banquet Speech, National Federation of the Blind. Future Reflections, the National Federation of the Blind Magazine for Parents of Blind Children, Winter 1992, pages 36-47.

 

[20]  Jernigan K. Blindness: Is History against us? 1973 National convention Banquet Speech, National Federation of the Blind, Future Reflections, the National Federation of the Blind Magazine for Parents of Blind Children, Fall 1992, pages 42-50.

 

[21]  Encyclopaedia Britannica, Micropaedia Volume X, pages 889 right, bottom, and 890 left, top to middle.

 

[22]  Hartman D, Asbell B. White Coat, White Cane, Simon and Schuster, New York, 1978.

 

[23]  Maurer M. Reflecting the Flame. 1991 National Convention Banquet Speech, National Federation of the Blind, in Future Reflections, The National Federation of the Blind Magazine for Parents of Blind Children, Winter 1992, 11: 1: 36-47, see pages 38 and 39.

 

[24]  Maurer M. Language and the Future of the Blind. Future Reflections, Special Issue 1989, 8: 4: 35-45.

 

[25]  Payer L. Disease-Mongers -- How Doctors, Drug Companies, and Insurers are making you feel sick.  John Wiley & Sons, New York, 1992. see Part One: "How to Create Disease" for an analysis of the incentives for physicians to make harmless conditions appear as terrible catastrophes.

 

[26]  Schlesinger ER. Fetal and Neonatal Mortality: A Public Health Problem. The New York State Journal of Medicine, July 15, 1952, 1758-1763, see page 1761 left, top: "An even more pessimistic attitude toward the premature infant prevailed fifteen or twenty years ago when only a few leaders in the medical profession insisted that the great majority of premature infants could be saved and become as useful citizens as full-term infants, provided they suffered no injury during birth.  A residue of the fatalistic attitude persists, perhaps justifiably to some extent, with respect to the premature infant whose birth weight is about or below 1,500 Gm.  The finding of an incidence rate of 5.6 per cent of gross visual defect due to retrolental fibroplasia in premature infants weighing less than 1,500 Gm, coupled with the higher incidence of cerebral palsy in this group, lends weight to this feeling."

 

[27]  The Schepens Eye Research Institute. Sundial, 20 Staniford Street, Boston, Massachusetts 02114, Spring 1993, see page 1, signed by Dr. Schepens, also pages 2 and 4

 

[28]  Parents of Premature and High-Risk Infants International, Inc.: An Interview with William A. Silverman, M.D., Greenbrae, California, in Support Lines, Winter 1984, 2: 1: 8-10, see page 10 right, near bottom.

 

[29]  Silverman WA. Retinopathy of Prematurity Over the Patient's Lifetime: A Clinician's Perspective, in Birth Defects: Original Article Series, 24: 1: 297-300, see page 299 near bottom, for an abbreviated version of the anecdote quoted in the preceding reference.


 


 

  

 

  

 Baby-harming medical research

 

about retinopathy of prematurity

by H. Peter Aleff, 2005 to 2009

 
 

 

 

2.3: Launching the big bogus study of oxygen

In the early 1950s, as the first large cohort of children blinded in American nurseries reached the age to go to school, the nursery doctors came under pressure to end the intensive care nursery epidemic which the overwhelmed providers of services to blind people had begun to perceive as an urgent national problem[1]. Ending the stream of blinded survivors by throttling their oxygen “subsidies” was still the convenient solution for a profession which had just demonstrated in its fight against National Health Insurance how little the public interest meant to its members.

Although the initial trial by Patz and Hoeck showed less blinding in the low-oxygen group, it was useless for convincing the skeptics. Despite the grant reviewers’ initial strong concerns about the risk of babies dying from insufficient oxygen, the study authors had conspicuously omitted to report the respective mortality rates in the routine versus low oxygen groups[2]. This information was, of course, essential for judging the risks of the “wild idea” they had proposed to test, and some readers may have wondered why they had withheld it.

A new and more authoritative study was needed, and here is Silverman’s eyewitness account about the relevant meeting in which he took part:

"... a small number of pediatricians and ophthalmologists met at the height of the retrolental fibroplasia epidemic in 1952. (...) The conferees began to argue vociferously about whether supplemental oxygen was or was not the cause of the RLF epidemic. At the height of the debates, Franklin Foote, Director of the National Society for the Prevention of Blindness, got up and reminded everyone that the blindness epidemic was an urgent national problem. 'We are not going to make any progress,' he said, 'if we continue to argue in this futile way. We need to think about what constructive action needs to be taken to hasten the end of this epidemic that has completely overwhelmed this country's facilities for the care of blind children.'  From that point on, the meeting took off in a very different direction. After very little discussion, the participants agreed on the urgent need for a definitive test of the burning question about the role of supplemental oxygen." [3]

To be fair, not all of those in the meeting joined the bandwagon.  Silverman noted also that

"One splinter group felt that limiting oxygen would require infants to undertake an unjustified risk of death and brain damage."[4]

However, the result of this meeting illustrates how easily political pressure can lead to the omission of all ordinary scientific precautions.  The outcome of this little discussed agreement was the 18-hospital Cooperative Study of Retrolental Fibroplasia and the Use of Oxygen. Its designers made no provisions to check in the aftermath of their hit-and-run trial for the mortality their oxygen withholding was bound to create, or for the less immediately visible damage which they knew would afflict the brains of those whom they had deprived of oxygen.  

In addition, that study was a blatant scientific fraud, and it also violated many of the then officially promoted standards of medical ethics.

 

2.4: Scientific frauds in the bogus oxygen study

The designers of that Cooperative Study of Retrolental Fibroplasia and the Use of Oxygen rigged the study procedures to hide and falsely deny the fatal danger of oxygen withholding. They knew that the preemies most at risk for ROP were the most immature ones with the lowest birth weights and the most immature eyes, and that these had also the most immature lungs, as documented in some of their statements:

"... infants in whom retrolental fibroplasia subsequently developed remained in the nursery, water jacket incubator and in oxygen for longer periods than the infants in whom retrolental fibroplasia did not develop. This suggests that the general health of the infants in whom retrolental fibroplasia subsequently developed may have been poorer than of those whose eyes remained normal, or possible that the latter were larger infants requiring a shorter stay in the hospital."[5]

"It was not startling to find that the small infants were given oxygen for long periods and the large infants for shorter periods." [...] "... the incidence was inversely related to the birth weight." [...] "The incidence of retrolental fibroplasia clearly varies with the degree of prematurity."  This paper relates also that the incidence was much higher in 1951 than in 1950, with over twice as many cases in the second year, but that no change in oxygen administration separated these years".[6]

"Our results conform with the experience of others in that the incidence of retrolental fibroplasia varies inversely with the birth weight."  [...]  "... some of the heavier infants who developed retrolental fibroplasia were never placed in incubators [where they receive oxygen]."[7]

These authors were further fully aware that babies with immature lungs who need help with breathing need this help right away, particularly during the first 12 to 24 hours, or else they will succumb quickly to their respiratory problems.  This is evident from pediatric textbooks of their time:

"[Congenital Atelectasis] is a condition of incomplete or delayed expansion of the lungs due to a persistence of the fetal state in one or several pulmonary areas. It is usually a sequel to asphyxia and the causes are those of asphyxia neonatorum.  Premature and debilitated infants are predisposed. (...)  Oxygen inhalations are indicated for cyanosis. (...)  The prognosis is good if the condition is of short duration.  Persistence of symptoms (...) offer an unfavorable prognosis and the development of pneumonia”. [...]  "During the first 12 to 24 hours, premature babies should be given plenty of oxygen on the slightest provocation and otherwise left alone."[8],

"It is advisable to place every premature infant, even if there are no signs of cyanosis, in an incubator containing a 40 to 50 per cent oxygen concentration, for at least the first 24 hours.  Cyanosis may occur in apparently healthy premature children from causes which would not bring about such a condition in infants born at term.  Any infection or minor obstruction of the respiratory tract may prove fatal, and the tissues become edematous if under-oxygenation is permitted for any length of time.  The oxygen concentration must be increased for premature infants with any indication of asphyxia.  The lungs of asphyxiated infants, being atelectatic, congested and edematous, are particularly susceptible to infection.  Bronchopneumonia should be suspected in any newborn premature infant with signs of asphyxia.  It is now conceded that many lesions formerly ascribed to trauma of delivery are in reality owing to asphyxiation."[9]

Knowing all this, the trial designers delayed the enrollment and the beginning of most  oxygen administration until the babies were 48 hours old.  By that time, 634 had died, and 786 survived to be enrolled.  Only 52 of these survivors had received any supplementary oxygen at all during their first two days[10], presumably from nurses like those at the Gallinger hospital cited above who had preferred helping the babies instead of blindly obeying doctors’ orders. 

The 45% of the babies who had died in those two days included, predictably, most of those who would otherwise have survived to grow up blind.  For comparison, the death rate among the 437 preemies born at less than 2000 gram in one of the participating hospitals during the immediately preceding years 1950 and 1951 had been 32% within the first seven days[11].

If that 32% rate of deaths had been maintained during the Cooperative Study, its death toll would have been about 454 babies, but its designers deliberately killed 180 more with their intentional oxygen withholding.

However, their deceptive protocol of killing the babies most at risk for blindness during the first two days, before their deaths would be counted, concealed the sharp rise in mortality which the perpetrators of this grotesque experiment knew their cure worse than the disease would produce. This deceptive trick allowed the kangaroo-court of show-trial judges to announce its knowingly false verdict that the oxygen withholding had virtually ended the blinding but had not affected the mortality rate.

Other signs that this study had been planned as a deliberate fraud are numerous.  For instance, long before any data from the study came in Reese had expressed his hope that oxygen would be “successfully incriminated”[12], a bias in favor of this outcome that ruled out any objectivity in his evaluation. And when the preliminary results did arrive, he led the meeting in September 1954 where he introduced as well as closed the prolonged presentation of the pre-arranged outcome from that study[13]

Yet, Reese's own writings on ROP show that he could not have believed a word of his accusations against the oxygen scapegoat because he had consistently maintained until then that the blinding was “without doubt” due to prenatal causes. As late as 1952, he had written another long paper in which he claimed again to have found ROP in the eyes of stillborn infants. He concluded again that the disease could be present at birth although demonstrable evidence for it at this early age was the exception:

“We find the typical pathology of retrolental fibroplasia in two sets of eyes obtained from infants who died at or shortly after birth. We can say, therefore, that the disease can be prenatal.  This is supported further by the rare occurrence of typical retrolental fibroplasia being seen clinically at birth.  If it can be assumed that skin hemangiomas have a common cause with retrolental fibroplasia, then we know that approximately 20 percent are seen at birth.  In the large majority of the cases of retrolental fibroplasia, however, there is no demonstrable clinical or histologic evidence of the disease at birth.” [14]

Although Reese’s “if it can be assumed ... then we know” style of thinking may have allowed him to bypass some rules of conventional logic, he still could not honestly have blamed postnatal oxygen administration for a condition he so firmly believed to exist sometimes already at birth and to have prenatal causes.

Moreover, Reese and his like-minded colleagues 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 remedy could therefore not suddenly have begun to cause the never previously encountered blinding. 

The scientific flaws in that trial included also statistical slight-of-hand that alleged to separate the babies' need for oxygen from their immaturity although one is clearly a function of the other.  A correlation between the pulmonary immaturity which makes the babies need oxygen and the ocular immaturity which predisposes them to ROP must be expected but is meaningless, as "The Oxford Textbook of Medicine" explains in more general terms, translated here in parentheses to match the case at hand:

"If factor A [the baby's immaturity] influences both factor B [the need for oxygen] and disease C [ROP], factor B and disease C will be associated statistically. The association between B and C will, however, be non-causal and there would be no hope of producing a change in disease C by manipulating factor B."[15]

2.5: “Better dead than blind” ethics violations in the bogus oxygen study

Like many of the grossly unethical Human Radiation Experiments which other U.S. doctors conducted around that time on other unsuspecting victims, the design of that oxygen withholding study also failed to meet the ethical standards that the medical community had proclaimed by then with much ado as its own alleged guidelines.  

Those flunked standards include several of the mandates in the Nuremberg Code of medical ethics which American physicians and judges had established just a few years earlier[16] to reassure the public that medical doctors would never again conduct unethical medical experiments on unconsenting subjects. 

Nuremberg Article 1 says the voluntary consent of the test subject is absolutely essential, and that this consent must be based on full disclosure of all the hazards reasonably to be expected. Similarly, the United States' laws about informed consent had long said that physicians have a duty to fully disclose all the facts which will allow a patient to balance the probable risks against the probable benefits[17]

However, the doctors who ran that oxygen study cannot have informed the parents about the study's stated purpose of risking death to maybe prevent blindness. Nor could they have told those parents about the brain damage which they knew to expect for their babies as highly probable side-effects from oxygen deprivation. 

Most sane parents would no doubt have refused to enroll their baby if they had been informed honestly that s/he would be exposed to a high risk of dying from easily avoided breathing problems, or else of growing up retarded and/or crippled, all in the tenuous hope that s/he or some other preemie might perhaps not lose their sight. 

On that subject, Articles 5 to 7 of the Nuremberg Code explicitly state:

"5.  No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur". 

"6. ... the degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment".

"7.  Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability, or death."

Each one of these Articles alone should have ruled out any tinkering with the life-saving oxygen.  The concept of intentionally withholding the needed breathing help to observe how many of the oxygen-deprived babies would die from its lack is even worse than the concept of the then ongoing and now rightly discredited Tuskegee syphilis study in which American doctors knowingly withheld easily available syphilis-curing treatment from patients for decades, until 1972, to observe the natural course of the disease[18].  

All the rules of ethics, medical or real, insist that exposing unconsenting people to a risk of death or any other possible harm is wrong, whether in the interest of science or any other. It is also wrong whether the victims are put in harm's way by coercion, as in the concentration camps which inspired the Nuremberg Code, or by deceit, as in the Tuskegee syphilis study and in the Cooperative oxygen trial.  

The risk of death clearly exceeds the importance of avoiding blindness as the whole exceeds the part.  Doctors killing or maiming patients to maybe save the sight of some among them is even more absurd than religious Inquisitors killing and torturing heretics to maybe save their souls. The soul, at least, was deemed an essential part of a person. Sight is not.

Most non-suicidal blind or sighted people, including physicians, would probably not want to risk their own life just to gain or maintain sight.  Many blind people say blindness is not a major handicap but only an inconvenience;  it certainly does not prevent them from leading independent lives as satisfying and productive as those of their sighted counter­parts[19],[20]

For instance, the National Hero of Bohemia, Jan Zizka, a statesman and general whose innovative tactics and strategies saved his country six hundred years ago from much superior forces, was blind in both eyes[21].  There is also at least one case of a boy totally blinded in childhood who became a successful physician and wrote a useful book about the special obstacles he encountered, describing the solutions that helped him and that may now help others[22]

Blind people count among them artists and athletes and barbers and engineers and entrepreneurs and fathers and mothers and more; with only minor exceptions, such as car driving, they fill about as many roles as sighted people do. And each of them is a person and entitled to life and respect, no less than you or I.

But some medical doctors deny blind people this basic respect and demonize blindness. Bad images often hurt good people, as many victims of discrimination against stereotypes can testify. This is why organizations such as the National Federation of the Blind have long been campaigning against damaging images of blindness.  Typically, when they alert offending individuals that their portrayals of blind persons are negative and harmful, those responsible usually soon recognize their error, apologize, and withdraw the offending statement.

However, some doctors are less civilized. Marc Maurer, President of that Federation, is a lawyer blind from ROP who was born just in time before the oxygen withholding doctrine would otherwise have suffocated him.  He has for many years exposed the unscientific and irresponsible behavior of physicians who falsely portray blindness as a hindrance to thinking and as leading to demented behavior[23],[24]

Yet, some disease-mongering[25] medical organizations continue to promote and exploit their “better dead than blind” myth that life without sight is without value.  At the time of the oxygen withholding trial, this medical myth helped to spread the idea that blindness would be worse for preemies than brain damage or death, and the same myth still lingers behind today's oxygen curtailment.   

Some comments from the Associate Director of the New York State Department of Health's Division of Medical Services, made shortly before the 1953/54 bogus oxygen withholding trial, illustrate the then medical perception of blindness. He justified his and his colleagues' pessimism about the futility of "salvaging" babies below 1500 grams on the grounds that 5.6% among them would have gross visual defects due to retrolental fibroplasia, and some others would suffer from cerebral palsy[26]. In other words, better twenty children dead than one of them blind and maybe a few in wheelchairs.

More recent examples of this same damaging attitude include, for instance, the fundraising magazine of the Schepens Eye Research Institute, an Affiliate of Harvard Medical School. Several articles in its Spring 1993 issue, including one by that Institute's much celebrated founder, suggest that without visual function a person has no autonomy, that early loss of sight may impair all aspects of physical and mental development, and that more eye research will reward society with healthy, independent, contributing individuals – implying that blind people are excluded from that category. Here are some excerpts:

"... innovative surgical techniques developed here allow children with ROP to retain some visual function, and therefore autonomy, rather than facing total blindness." [...] "The rewards for society [from support of eye research] are healthy, independent, contributing individuals."  [...]  "blinding eye diseases are [...] doubly tragic when they strike the very young, since early loss of sight may impair all aspects of physical and mental development." [...]  "Development of vision is inextricably tied to improvement in motor skills, as the child learns to use vision to orient himself in space, affecting balance, posture, and movement."  "Impaired vision can also slow mental, social, and psychological development."  [...]  "What they gain is some sight: the ability to detect light and shadow, general shape, and especially movement. In many cases, it is enough to enable them to move about the house or cross the street safely."[27]

Even Dr. Silverman, one of the very few physicians who appears to have cared about the later fate of some ROP victims and who had long raised critical questions about the consequences of oxygen withholding -- even he conveyed the message that blind babies should not be helped to live. He offered repeatedly an anecdote about a man blind from ROP who visited an intensive care nursery "to 'see' the babies":

"... the nurse turned to him and asked, 'I wonder if you feel we are right trying to keep all these small babies alive knowing that some of them may be blind?' The young man struggled with the question, burst into tears and said, 'No. I don't think you should do it.' This was a very emotional moment that had quite an impact on me."[28],[29]

The emotions such anecdotes stir up have an even greater impact on the life and death of preemies when medical experts yield to them and rule that blindness is a worse problem for blind people than most blind people think it is. 

Many societies have long agreed that doctors have no right to decide whether some people's risk of blindness or other disabilities makes them unworthy of life. Yet, in intensive care nurseries all over America and in many other countries that follow the American model of preemie care, otherwise humane but doctrine-duped nursery doctors still make this decision daily, each time they restrict a preemie's oxygen supply to “protect” her from ROP.

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