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Footnotes :

 

72 Starr P. The Social Transformation of American Medicine: The rise of a sovereign profession and the making of a vast industry. Basic Books, New York, 1982, page 347, second half.
 

73 Silverman WA: Retrolental fibroplasia: a modern parable. Grune & Stratton, Inc., New York, 1980, pages 56-58.

 

74 Avery ME, Taeusch HW, Floros J. Surfactant Replacement. New Engl J Med, Sept 25, 1986, 315: 13: 825-826.

 

75 Eidelman AI. Economic Consequences of Surfactant Therapy. Journal of Perinatology, 1993, 13: 2: 137-139. See page 138 right top for cost approaching a half billion dollars, page 138 left, bottom, for higher neurological damage, page 137 right, end of first paragraph, for 1200 extra survivors, and Table 1, page 138 right, top, for up to 3750 additional survivors.

 

76 Bancalari E, Flynn J, Goldberg RN, Bawol R, Cassady J, Schiffman J, Feuer W, Roberts J, Gillings D, and Sim E. Influence of Transcutaneous Oxygen Monitoring on the Incidence of Retinopathy of Prematurity. Pediatrics, May 1987, 79: 5: 663-669, see page 664 right, middle.

 

77 Phelps DL. National Eye Institute Grant Application No. 1 U10 EY09962-01, Draft Manual of Procedures, Multicenter Trial of Supplemental Therapeutic Oxygen for Prethreshold Retinopathy of Prematurity (STOP-ROP). Draft 1/27/92, Exhibit 2-3: Arterial PaO2 Values in Various Subjects, page 2-8.

 

78 Phelps DL. National Eye Institute Grant Application No. 1 U10 EY09962-01, Draft Manual of Procedures, Multicenter Trial of Supplemental Therapeutic Oxygen for Prethreshold Retinopathy of Prematurity (STOP-ROP). Draft 1/27/92, pages 7-2,3.

 

79 Phelps DL. National Eye Institute Grant Application No. 1 U10 EY09962-01, Draft Manual of Procedures, Multicenter Trial of Supplemental Therapeutic Oxygen for Prethreshold Retinopathy of Prematurity (STOP-ROP). Draft 1/27/92, page 2-9.

 

80 Bancalari E, Flynn J, Goldberg RN, Bawol R, Cassady J, Schiffman J, Feuer W, Roberts J, Gillings D, and Sim E. Influence of Transcutaneous Oxygen Monitoring on the Incidence of Retinopathy of Prematurity. Pediatrics, May 1987, 79: 5: 663-669, see page 665 right, near bottom, for correlation of oxygen monitoring and increased mortality rate.

 

81 Rothman K., identified as an epidemiologist from Boston University: the cookbook recipe concept of significance is "a clumsy substitute for thought [that can] blind the investigators to the information in their data". as quoted in Newsweek, March 22, 1993, in an article about the pending Supreme Court decision on "junk" science versus "good" science, page 63 middle right.

 

82 Phelps DL. Vitamin E and Retinopathy of Prematurity: The Clinical Investigator's Perspective on Antioxidant Therapy: Side Effects and Balancing Risks and Benefits. Birth Defects: Original Article Series, 1988, 24: 1: 209-218, see page 214 top: the number of babies born in 1985 with birth weights of less than 1500 grams is here given as 42,000, and that of survivors among them as 26,200.

 

83 National Center for Health Statistics. Advance Report of Final Natality Statistics, 1990, Monthly Vital Statistics Report, Vol 41 No. 9, suppl. Hyattsville, Maryland, Public Health Service, 1993; see Table 29, page 43 top: The number of babies born in the United States in 1990 with birth weights below 1500 grams was 52,915. An 8% higher mortality rate among these would mean 4,233 more deaths.

 

84 Phelps DL. National Eye Institute Grant Application No. 1 U10 EY09962-01, Draft Manual of Procedures, Multicenter Trial of Supplemental Therapeutic Oxygen for Prethreshold Retinopathy of Prematurity (STOP-ROP). Draft 1/27/92, page 2-4: Estimates of ROP morbidity for 1991: 4,479 with cicatricial disease and 777 totally blind if no cryotherapy is used; this is reduced to 2,060 cicatricial and 412 blind if cryotherapy works as expected.


 


 

  

 

  

  Preemies gasping for breath

 

are denied the breathing help they need 

 
 

Davidpreem01.jpg (20108 bytes)

Medical oxygen- starving
practices and experiments

by H. Peter Aleff

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2.7. Current deaths from oxygen monitoring

More of the smaller preemies survive now, but not yet all those who could escape death and brain damage if only they received enough oxygen. Beginning in the mid to late 1960s, the Zeitgeist called for easing overly tight restrictions72; for instance, the American Medical Association relaxed its previously very tight restrictions on the nation's supply of physicians.

In tune with this trend, the oxygen withholding became slowly and gradually and quite tacitly a little less Draconian73, and the death rates slowly and gradually and much less tacitly resumed their descent.

In addition, various more recently developed surfactant preparations introduced every few hours into the preemies' lungs74 help the expansion and deflation of the alveoli and allow many of the smaller preemies to absorb the incoming thin oxygen more efficiently, almost as well as if that gas arrived in higher concentration.

This treatment, at a yearly country- wide cost approaching a half billion dollars, plus a higher rate of neurological damage among the survivors, thus counters partly the purpose and effects of the elaborate and even more expensive oxygen rationing and so helps an estimated 1200 to 3750 babies a year to stay alive75.

However, a study at the University of Miami/Jackson Memorial Medical Center, published in the May 1987 issue of Pediatrics, suggests that some babies still die unnecessarily from oxygen rationing. According to the trial report, five pages from ten authors all unconcerned by the harm their experiment had done to the babies, merely a closer monitoring of the already rationed oxygen supply seems to have killed about one extra preemie in twelve among those with very low birth weights.

In one of two matched groups of preemies with birth weights up to 1300 grams, the experimenters had continuously monitored the babies' arterial oxygen concentrations to maintain them as much as possible in a predetermined range of 50 to 70 mm Hg76.  For comparison, the normal range for healthy preemies with mature lungs is the same as for adults: 80 to 100 mm Hg77.

Most of the intensive care nurseries in the USA try to maintain preemies who need oxygen at 45 to 85 mm Hg for 90% of the time78. This corresponds to blood oxygen saturations of only 90 to 95%, less than the at least 96% an infant with more mature lungs should obtain from room air before the oxygen supplementation is discontinued79.

The babies in the control group had received standard care which means their oxygen was also rationed with the intent to keep it in the same low range, but their oxygen levels were monitored only about a third of the time, and thus less tightly.

Consistent with all the prior studies of oxygen and ROP, this one failed again to show a clear relationship between oxygen administration and either the incidence or the severity of ROP. The expensive monitoring and constant taping of painfully hot electrode pads to the few not-yet- reddened spots on the tender skin of the preemies had not helped to reduce either.

The mortality figures, however, revealed the deaths of twelve extra babies in the continuously monitored group of 148, or 8% more. For the babies born above 900 grams, the death rate in the monitored group was over 11% higher than among those who had received oxygen a little more freely.

The authors computed the probability that this difference might be due to chance as 6% which means a 94% probability that the extra deaths were due to the monitoring.  They said:

"The excess mortality in the continuous monitoring group infants was due mainly to massive intracranial hemorrhage and necrotizing enterocolitis. It can be speculated that the use of transcutaneous oxygen monitoring may have increased the risk of these complications in the continuous monitoring group, but the fact that the difference was only observed in the larger infants makes this possibility less feasible."80

On the other hand, it would be equally valid to speculate that the smallest infants, those whose mortality rate was apparently not much affected by the monitoring, suffered from so many other problems of immaturity that they tended to die from many causes which were beyond oxygen's power to cure.  The larger babies were more ready to live and may have needed only a little more breathing help to put them over the threshold of viability.

To dismiss the observed correlation between tighter monitoring and higher death rate despite its high statistical probability is therefore an ad hoc interpretation incompatible with rational inquiry.

However, none of the investigators or their reviewers expressed any concern or raised any alarm about the fatal outcomes that were so strongly associated with the useless monitoring and constant hot-pad pain.

Physicians are taught to regard correlations between treatments and effects as "not significant" until that probability of a chance result reaches or becomes smaller than 5%; unfortunately, many apply this "clumsy substitute for thought"81 cookbook recipe also to the evaluation of harmful side effects although there, any positive association should be a danger signal.

The relative differences in mortality between babies with different accuracies of oxygen rationing in this trial allow no absolute-numbers estimate about the nationwide toll from the current practices, but an extrapolation can help to illustrate the potential consequences of just a small turn on the oxygen valve:

If a similar relative tightening of each hospital's current oxygen administration produced a similar 8% rise in mortality for the estimated annual 42,000 (in 1985)82 to 53,000 (in 1990)83 American children with similarly low birth weights, then such a slight further restriction of the already rationed oxygen supply would correspond to the deaths of about 3,360 to 4,240 extra babies a year, roughly as many as are said to now suffer vision problems from ROP84.

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