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and a documentation of   patient-harming frauds in medical research

 

 
Footnotes:

 

29 Charity report, op. cit., page 5, bottom left and top right.

 

30 W.T. Ham, Jr., H.A. Mueller, J.J. Ruffolo, Jr., J.E. Millen, S.F. Cleary, R.K. Guerry, and D. Guerry, III: "Basic mechanisms underlying the production of photochemical lesions in the mammalian retina", Current Eye Research, Volume 3 No. 1, 1984, pages 165 to 174, see page 167, right, bottom.

 

31 W.T. Ham, Jr., R.G. Allen, L. Feeney-Burns, M.F. Marmor, L. M. Parver, P.H. Proctor, D.H. Sliney, and M.L. Wolbarsht: "The Involvement of the Retinal Pigment Epithelium (RPE)", pages 43 to 67 in Waxler M. and Hitchins VM, eds.: "Optical Radiation and Visual Health", CRC Press, Boca Raton, Florida, 1986; see page 57 middle.

 

32 L. Johnson, F.W. Bowen, Jr., S. Abbassi, N. Herrmann, M. Weston, L. Sacks, R. Porat, G. Stahl, G. Peckham, M. Delivoria-Papadopoulos, G. Quinn, and D. Schaffer: "Relationship of Prolonged Pharmacologic Serum Levels of Vitamin E to Incidence of Sepsis and Necrotizing Enterocolitis in Infants with Birth Weight 1,500 Grams or Less", Pediatrics, Volume 75, No. 4, April 1985, pages 619 to 638, see page 626 left, middle.

 

33 S. Sobel, J. Gueriguian, G. Troendle, E. Nevius, Food and Drug Administration: Letter to the Editor, New England Journal of Medicine, April 8, 1982, page 867 right, middle.

 

34 Ronald Munson: "Intervention and Reflection - Basic Issues in Medical Ethics", Wadsworth Publishing Co., Belmont, California, 1979, page 231.

 


 


 

  

 

  

  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

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My letter to Dr. Feinstein, continued from page 4
Lazy ignorance and lack of ethics in studies of Vitamin E on premature babies:

Charity Hospital also administered higher doses of vitamin C ("in increasing amounts up to 100 mg daily by the fourth day and continued in this dosage thereafter"29) than most other nurseries at the time. This free-radical-scavenger vitamin is said to act synergistically30 with the other such scavenger, vitamin E, and to restore the antioxidant capabilities of the latter31, so the C may have helped the Charity babies to make better use of their limited natural vitamin E stores in repairing the free-radical-mediated retinal damage typically caused by excess light.

Let me point out here that the contradictory results from the many studies of vitamin E for the prevention of ROP are easily explained by the simple fact that most of these studies did not take this interaction into account or even reported the amounts of vitamin C administered together with the E to be studied.

This overly reductionist and pseudo- scientific approach in those studies, mindlessly repeated for decades just like the light- blinding studies with always the same flagrant flaw, is therefore like evaluating the holding power of two- part epoxy glues while forgetting to measure or even add the hardener.

It is certainly a step backwards from the "pre- scientific" medicine that appreciated at least how important it was to balance its four humours.

Another step backwards in at least one of these vitamin E studies was a return to pre- Nuremberg- Code "medical ethics".  In a paper submitted in September 1984 to Pediatrics and published there in April 1985, the twelve authors from three Philadelphia hospitals who signed for that study explained how they had tested the "Relationship of Prolonged Pharmacologic Serum Levels of Vitamin E to Incidence of Sepsis and Necrotizing Enterocolitis in Infants with Birth Weight 1,500 Grams or Less"32.

In April 1982, over two years before these authors finished this Vitamin E study, a group of physicians from the FDA had warned in the New England Journal of Medicine that high levels of Vitamin E increased the incidence of necrotizing enterocolitis (NEC)33, a painful and often fatal bowel disease which affects preemies. These FDA writers said that with blood levels above 3.5 mg of E per deciliter of blood, the disease developed in 30% of the babies, but only in four per cent of the babies with less E in their blood.

Yet, the trial team chose 5.0 mg per deciliter as their target level for the treatment group (their page 619 bottom right) and achieved E levels as high as 8.5 mg (page 626 top right). Not surprisingly, these deliberate overdoses resulted in 20 more babies with sepsis and 14 more with NEC than in the placebo group, and the researchers found that

"the difference between treatment groups shows a strong trend in the direction of more disease among vitamin E-treated infants." (page 627 bottom left)

The study authors were not content with so overdosing half the babies and then blaming the vitamin for their carelessness.

To increase the contrast between their study groups, they also deprived the other half of the minimum essential for their survival. To obtain "a consistently wide separation of serum vitamin E levels between treatment groups" (page 626 top right), the controls received only minimal doses even when they would have needed more to remain in the sufficient range:

"In only 28 (10%) of placebo-treated infants (15 of whom died before age 20 days) did the serum vitamin E levels remain in the clearly deficient range (0.3 to 0.5 mg/deciliter) that characterized all placebo-treated infants in our 1972 to 1974 clinical trial." (emphasis added)

In other words, these nursery doctors intentionally withheld from babies in both their studies sufficient doses of the vital nutrient which they knew to be needed for their better chance of survival, just so that these babies would remain clearly deficient in it.

Their callous endangering and careless killing of the so deprived babies for the sake of clearer results in their alleged science was thus no different from the Tuskegee study where doctors withheld needed treatment from patients whose disease they wanted to study.

That study was phased out in 1970 and condemned in 1973 both on moral grounds and because of its lack of worth and rigor34, but its above Philadelphia sibling continued on the same track and then repeated the same violations again a decade later while Santayana kept turning in his grave.

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