Frauds, cover-ups, and other ethics violations in medical studies of preemies
by H. Peter Aleff
Attachments for my letter to Dr. Feinstein on pages 1 to 8
The items below were attached to the letter in this series and are posted here, except for the clinical articles and the biological exposure indices which can be examined in most medical libraries:
Title page 527 and "Abstract of Discussion" pages 549 to 552 that follow Dr. Algernon B. Reese's "Persistence and Hyperplasia of Primary Vitreous; Retrolental Fibroplasia -- Two Entities" in Archives of Ophthalmology, Volume 41, Number 5, May 1949; see page 550 top for the euthanasia proposal against premature babies at risk for the blinding.
Two illustrations from 1893 of incubators for premature babies that both show the oxygen supply pipe as one
of their important features.
A picture of the Hess incubator bed that reportedly exempted its inmates from the blinding. Note the opaque cover and the shading hood.
From Jeffrey P. Baker: "The Machine in the Nursery -- Incubator Technology and the Origins of Newborn Intensive Care", The Johns Hopkins University Press, 1996, pages 72, 83, and 170.
Extracts from the 1995 Manual of Procedures (MOP) for the LIGHT-ROP study, by Drs. Reynolds, Spencer et al.:
Extracts from four of the main references cited in the LIGHT-ROP MOP chapter on Retinal Light Toxicity to describe the photochemical damage that is the subject of the study and that these papers report as inflicted in exposures much shorter than the up to 24 hours in the LIGHT-ROP study :
LIGHT-ROP MOP-2 reference 45, cited on pages 2-9 bottom, 2-10 top, and 2-11 middle: "Separate Mechanisms for Retinal Damage by Ultraviolet-A and Mid-Visible Light" by Rapp, Tolman, and Dhindsa, Invest. Ophthalmol Vis Sci 31:1186-1190, June 1990: pages 1186 to 1188.
LIGHT-ROP MOP-2 reference 47, cited on page 2-10, line 12: "Damage to the monkey retina by broad-spectrum fluorescent light" by Sykes, Robison, Waxler, and Kuwabara, Invest. Ophthalmol Vis Sci 20:425-434 April 1981: pages 425 and 432, 433.
LIGHT-ROP MOP-2 reference 54, cited on page 2-11, lines 13, 14, and again 17: "Possible Mechanisms of Photoreceptor Damage by Light in Mammalian Eyes" by W.K. Noell, Vision Res 20:1163-1171, 1980: pages 1163 and 1166.
LIGHT-ROP MOP-2 reference 55, cited on page 2-11 middle, lines 10, 14, and 17: "Basic mechanisms underlying the production of photochemical lesions in the mammalian retina" by Ham, Mueller, Ruffolo, et al., Curr Eye Res 3:165-174, 1984: pages 165 and 168.
Extracts from the 1995 - 1996 Threshold Limit Values (TLVs) for Chemical Substances and Physical Agents and Biological Exposure Indices (BEIs) issued by the American Conference of Governmental Industrial Hygienists:
Title page with policy statement on the uses of TLVs and BEIs; Copyright notice, address, and Table of Contents;
Chapter on Light and Near-Infrared Radiation, pages 104 to 107, for exposures not to be exceeded in any 8-hour workday, highlighted for the threshold in shorter exposures of up to 10,000 seconds, and
Extract from chapter on Lasers, pages 98 and 99, marked up for light from 400 to 549 nm in exposures from 10 to 10,000 seconds.
Letter of October 23, 1989, from Dr. Rand Spencer, LIGHT-ROP co-author, to Mr. Bill Sardi at Eye Communications, Inc., in which Dr. Spencer acknowledges Mr. Sardi's warnings about short wave length light emissions from fluorescent lamps.
Extracts from the National Eye Institute's LIGHT-ROP grant file:
Letter of February 1, 1997, from Dr. Reynolds to Don Everett, NEI, with an update of the study enrollment and further schedule, and Dr. Reynolds' Progress Report to the NEI;
Letter of March 7, 1995, from NEI to Dr. Reynolds, adding the initially omitted Data and Safety Monitoring Committee;
Letter from Dr. Reynolds to Don Everett, received at the NEI on January 17, 1995, comparing the LIGHT-ROP study with a similar recent study in Germany and stating the LIGHT-ROP nurseries will be even brighter;
Letter of September 26, 1994, from Dr. Reynolds to Dr. Mariani at the NEI, saying that even a negative study result would be "extremely useful".
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