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1 "Remarks by President William J. Clinton in Acceptance of Human Radiation Final Report", October 3, 1995, as reprinted in "The Human Radiation Experiments - Final Report of the President's Advisory Committee", Oxford University Press, New York, 1996, pages xvii to xix, quote on page xix left.






  Greatly fanfared government watchdogs


never meant to do their job


Davidpreem03.jpg (16608 bytes)

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

  You are
   on page

1    2    3    4    5    6    7    8    9   10   11

Instead of a reply to my letter posted on the preceding pages, the National Bioethics Advisory Commission sent me a copy of its letter dated April 14, 1997, to

Dr. Gary B. Ellis, Ph. D., Director,

Office for Protection from Research Risks

6100 Executive Boulevard, Suite 3B01

Rockville, MD 20892-7507


Dear Dr. Ellis,


Dr. Harold Shapiro forwarded the enclosed information (provided by Mr. H. Peter Aleff) concerning "LIGHT-ROP, The Effect of Light Reduction on Retinopathy of Prematurity" study funded by the National Eye Institute. We are providing you with this information since your office exercises compliance oversite (sic) regarding Department of Health and Human Services (DHHS) regulations involving research conducted or supported by any component of DHHS.


As you know, it is not within the purview of the President's charge to the Commission to examine individual cases. We would appreciate it if you would follow-up directly with Mr. Aleff.


Thank you for your prompt attention to this matter.



Henrietta Hyatt-Knorr
Deputy Executive Director (Acting)

cc: Dr. Harold T. Shapiro
     Mr. H. Peter Aleff



My letter of May 1, 1997, to a member of the President's Advisory Committee on Human Radiation Experiments

Professor Jay Katz

Yale Law School

P.O. Box 208215

New Haven, CT 06520-8215

Dear Professor Katz:

I read with great interest your "Statement by Individual Committee Member" appended to the Final Report of the President's Advisory Committee on Human Radiation Experiments, and I appreciate it that you took the time to perform and offer your own analysis of whether current regulations of human experimentation adequately protect patient-subjects.

You concluded that the present system is flawed and invites repetitions of the Cold War abuses your Committee investigated, and you expressed concern that such repetitions might undermine the public trust.

I want therefore to bring to your attention a cluster of long-standing and still continuing medico-governmental abuses of intensive care nursery patients that have killed more Americans than the Vietnam war and blinded more children per year than all other causes combined, and that continue to claim many victims daily. The continued hiding of these abuses is likely to fan the public's cynicism because government agencies in charge of preventing precisely such abuses prolong them instead.

The case I describe is an American parallel to Lysenkoism in that a few government- sponsored physicians imposed decades ago a clearly unscientific doctrine on their subspecialty that its proponents still defend at all cost, even with fraud.

The latest example of that fraud is a currently ongoing clinical experiment that violates patients' rights even more than the infamous Tuskegee study which you helped investigate and for which President Clinton apologized recently while scheduled to soon offer again the same  governmental apologies.

In Tuskegee, the doctors left patients without an available treatment that would have protected them. In the National Eye Institute's present LIGHT-ROP trial, the researchers leave the premature babies in their control group not only without easily available protection against a radiation they deem to be dangerous to preemie eyes, but they intentionally maximize the dose of that radiation to better distinguish the incidence of blindness between the "protected" babies and those in the control group.

You will find enclosed a copy of my March 24 letter to Professor Harold T. Shapiro, Chairman of the current National Bioethics Advisory Commission, together with all the documentation listed on its pages 4 and 5.

I describe in that material the iatrogenic but government-supported reasons behind the ongoing twin epidemics of baby-killing and baby-blinding, and I show how the above study is a scientific fraud designed to perpetuate the status quo.

I am also enclosing the answer I just received from the Deputy Executive Director of that Commission: my complaint was forwarded to the Office for Protection from Research Risks because "it is not within the purview of the President's charge to the Commission to examine individual cases". I find this strange since the President said he had created that Commission

"to supervise the process [of government agencies reviewing their procedures for ethics in research on human subjects}, to watch over all such research, and to see to it that never again do we stray from the basic values of protecting our people and being straight with them.1"

The President did not mention a Laputa-exemption from having to deal with individual and specific cases, and he certainly did not hesitate recently to have said Commission examine the individual case of one cloned sheep.

This reaction alone is thus likely to increase the cynicism the public feels towards such evasions.  Are the people to be so protected not all individuals? And what good are ethics so abstract that they disdain to deal with concrete cases?

I am even more surprised that the Commission considers decades of baby-killing and brain-damaging and -blinding and governmental cover-up as an "individual case" when the number of victims from that case exceeds by far the number of all those affected by all the Cold War radiation experiments that your Committee made such an effort to investigate.

People are bound to contrast the Kafka-esque inadequacy of this real-life reaction from the Commission with the President's promise that the government would make itself accountable and end the stonewallings of the past when those wronged had nowhere to turn.

By taking a month to misread my complaint about an ongoing harm to patients and to then shuffle it from its Suite 3C01 to the Research Risk Protection Office's Suite 3B01 at the same address, the Commission demonstrates that the President failed to provide a ladder to its ivory tower. The victims of current medical abuses and government stonewalling still have nowhere to turn, regardless of the President's public promises, or of the apologies he offers for past governments' sins.

I am therefore asking you to please intervene, if you can, and have the government remove the beam from its own eye before the President proclaims more contrition about the splinters in those of its predecessors.

If you succeed, you will save him from an embarrassment, and you will save the lives and brains and eyes of many babies here and around the world.

I thank you in advance for your kind help.

Sincerely, H. Peter Aleff


Reply received from Professor Jay Katz, Elizabeth K. Dollard Professor Emeritus of Law, Medicine and Psychiatry, and  Harvey L. Karp Professorial Lecturer in Law and Psychoanalysis at Yale Law School, dated May 14, 1997:

Dear Mr. Aleff:

Thanks for your letter and materials. I looked at them and they raise important ethical concerns. In the next few weeks I will talk with Gary Ellis and urge him to take a close look at what you submitted to him. That is probably all I can do at this time.

With warm regards,

Cordially, Jay Katz


Note: I heard nothing further from Professor Katz, and I conclude he and his colleagues lent their reputations, as well as those of their distinguished professorships and condoning institutions, to a sham Committe set up to falsely reassure the public about medical abuses it did not even try to curb.

The Office for Protection from Research Risks, which Dr. Gary Ellis directs, addressed none of my complaints about the avoidable risks to which the LIGHT-ROP trial intentionally exposed the preemies enrolled in it, nor did it see anything wrong with the deception of the parents about these risks.

Here is the reply of January 27, 1998, which I received from that Office, after much follow-up and repeated prodding from U.S. Congressman Frank A. LoBiondo who represents my district and was instrumental in making the Office at least reply to my complaint although he could not get them to address the charges:


TELEPHONE: 301-402-5552 FAX: 301-402-0527 e-mail: scl29b@nih.gov

RE: Human Research Subject Protections for research conducted under "The Effect of Light Reduction on Retinopathy of Prematurity" protocol      January 27, 1998

Dear Mr. Aleff:

The Office for Protection from Research Risks (OPRR) has completed its evaluation of human subject protections in the research referenced above.

OPRR has made the following determinations in regard to the above research:

  1. The Institutional Review Board (IRB) reviews at The Children's Hospital of Buffalo and The University of Texas Southwestern Medical Center at Dallas appear to have been conducted in compliance with Department of Health and Human Services Regulations at 45CFR46.

  2. The issues that you raised are a matter of scientific debate. As a result, there is no compelling reason for OPRR to question the decision of the local IRBs.

OPRR appreciates your concern about the protection of human research subjects. Please do not hesitate to contact me should you have any questions.

Sincerely,  Susan L. Crandall, M.D.
Acting Chief
Compliance Oversight Branch
Division of Human Subjects Protections OPRR
cc: Dr. Tom Puglisi, OPRR
     Mr. Paul Doell,
     U.S. House of Representatives

Continue here to the false reassurances of a LIGHT-ROP author about that trial, or see in the series on "Sovereign doctors" the persistence of the non-response and cover-up all along the further path of this complaint through the bureaucratic maze to its dead end at the medical stonewall.

Find out there also how the current DHHS Regulations do indeed allow the ethics violations described and are set up so they would again approve without reservation the study protocol for the infamous Tuskeegee Study if it was submitted today under a different name.



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