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My complaint to the National Bioethics Commission, and that sham Commission's indifference
to real abuses
   
by H. Peter Aleff

 You are on page

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To document this cluster of doctrinal malpractices and deceptions, I am sending you enclosed the items below to which I will refer as I explain the above charges:

  • my 1996 book "The Medical Ethics Trap behind Retinopathy of Prematurity and Much Cerebral Palsy" which contains a discussion of that retinopathy and of the pediatric approach to its epidemic. It also includes some of my correspondence about that baby-blinding with government officials and physicians.
     

  • the application for the original LIGHT-ROP trial planning grant by Dr. Rand Spencer at Texas Retina Associates in Dallas, funded by the National Eye Institute's grant award
    #1 R21 EY08623-01 of July 17, 1989.
     

  • the application for the current LIGHT-ROP feasibility study grant, submitted in late June, 1994, by Dr. James D. Reynolds of Buffalo who is now the principal investigator and names Dr. Spencer as his co-investigator; this application was funded by NEI grant awards 42 USC 241 31 USC 6305 & 6306 of March 21, 1995. The feasibility study in this application is simply a scaled-down test-run for the much larger multi-hospital, nation-wide experiment that Dr. Spencer had originally proposed.

  • a video cassette with three short TV programs on ROP and light.

The following smaller items are stapled together in the order below:

  • extracts from the Manual of Procedures for the LIGHT-ROP study, collated by Drs. Reynolds, Spencer et al. on August 8, 1995. These are:

  • the title page with the researchers' names and the date;

  • pages 2-9 to 2-22 with chapters on Retinal Light Toxicity, the Pathophysiologic Mechanism of ROP, Light and ROP, and Summary and Analysis;

  • pages 3-4 to 3-7 on Light Reduction Methods; pages 4-13 and 4-14 on Monitoring Compliance with Treatment Assignment;

  • pages 5-1 to 5-7 on Monitoring Light Levels in the Nursery;

  • pages 7-1 and 7-2 on Monitoring Protocol Assurance;

  • pages 8-9 to 8-11 on Data and Safety Monitoring Committee.
     

  • an extract from the 1996-97 "Guidelines for Design and Construction of Hospital and Health Care Facilities": Section 7.32.D6. on Lighting.

  • selected abstracts from a September 1996 Medline search for clinical articles on oxygen and ROP.

  • a quote from the 1987 textbook "Neonatology" about the pediatric view of the intensive care nursery as a bustling space station, as opposed to a "quiet, restful, and gentle" place for vulnerable babies.

  • the National Eye Institute's letter of January 27, 1997, to me, informing me that the allegedly submitted Investigational Review Board letters for the LIGHT-ROP study are not in their file.

  • the parental consent form from Buffalo which the National Eye Institute initially refused to release but which Mrs. Margaret Watson, founder of the "Prevent Blindness in Premature Babies" parent group, obtained in November 1996 through the intervention of US Senator Feingold.

  • the parental consent forms from Dallas, San Antonio, and Santa Rosa which the NEI sent me subsequently. (The approved grant application had only mentioned Buffalo and Dallas, not the other two study sites.)

  • a transcript of the ABC NEWS 20/20 program of December 6, 1996, on Senile Macular Degeneration.

  • an article on Senile Macular Degeneration: "Losing Sight" by Henry Grunwald, from The New Yorker, December 9, 1996.

All the abuses I describe would automatically be eliminated if the parents of the victims were fully informed about what the doctors do to their children. I will therefore discuss these malpractices as they relate to the several layers of deception in the parental consent form.

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