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The non-response of the alleged bioethics guarantors to an inquiry by a member of US Congress
by H. Peter Aleff
 

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Letter dated May 28, 1998, from
U.S. Congressman Frank A. LoBiondo
2 Cannon House Office Building 
Washington, DC  20515-3002
Phone 202-225-6572. Fax 202-225-3318, and 5914 Main Street
Mays Landing, NJ 08330
Phone 609-625-5008 Fax 609-625-5071

COMMITTEES:
TRANSPORTATION AND INFRASTRUCTURE SUBCOMMITTEES:
COAST GUARD AND MARITIME TRANSPORTATION, VICE CHAIRMAN
WATER RESOURCES AND ENVIRONMENT
SMALL BUSINESS SUBCOMMITTEES:
REGULATORY REFORM AND PAPERWORK REDUCTION,  EMPOWERMENT

Dear Mr. Aleff:

Knowing of your concern regarding the Light-ROP studies being conducted by the National Eye Institute (NEI), I wanted to inform you of the results that have just been released.  Enclosed you will find a press release from the NEI and an article that will appear in the New England Journal of Medicine concerning the studies that have been completed in the field of ROP.

I understand the findings are probably not to your liking. I have consulted with the Congressional Research Service (CRS) and they have indicated to me that they believe that all possible safety precautions have been followed during the course of the study. CRS also indicated they do not think there is any reason not to believe the results of the study are valid and meaningful.

Your work and study in the field of ROP has been very impressive and useful to me. I am hopeful you will continue to keep me informed about your efforts and any further developments. Working with hospitals and other individuals concerned about this problem will certainly yield valuable information to one day eliminate this terrible disease.

I hope this information is useful to you. Please feel free to contact myself or Paul Doell of my staff should your require further assistance.

Sincerely,

Frank A. LoBiondo
Member of Congress

*

My reply of June 12, 1998, to
US Congressman Frank A. LoBiondo

Dear Mr. LoBiondo:

Thank you for your letter of May 28 and the news release from the National Eye Institute with its attached article. I received your envelope right as I returned from mailing you yesterday's follow-up note and copy of my recent letter to Mr. Gavzer from Parade Magazine. The follow-up question is therefore moot, but the message on the cartoon still stands: "I was expecting something more."

I am disappointed that the Congressional Research Service told you they believe that all possible safety precautions have been followed during the course of the baby-blinding study, and that there is no reason not to consider the results of the study as valid.  Did they refute any of my fully documented charges, or do they simply participate in the same traditional cover-up of medical ethics violations as all the other alleged watchdog agencies so far?

Could you please ask the Research Service to turn over to you their correspondence as well as all internal documents and notes related to their alleged investigation, as you did with the Office for Protection from Research Risks? You may want to find out how little you can trust that supposedly impartial Service, and I would appreciate it very much if you could then send me a copy of their file.

My accumulating documentation has become a case study in how the government's guarantees against medical transgressions really work, and this file will help to nail down the paper trail from the successive failures of the supposedly fail-safe system for protecting the public from unethical doctors.

I thank you in advance for your continued kind help, and I look forward with great interest to hearing from you. I remain

sincerely,

H. Peter Aleff
cc: Paul Doell

*

The reply of October 8, 1998, from US Congressman Frank A. LoBiondo to me:

Dear Mr. Aleff:

Knowing of your interest in obtaining information on the Light ROP case I have contacted the Congressional Research Service (CRS) to request the information and documents they used to review this situation.

Per your request, I have enclosed information that CRS looked at during its inquiry. You may be disappointed to know that there are no internal written documents with regards to CRS's review.

It is my understanding that they reviewed your documents and looked at the published information on the Light ROP study conducted by the National Eye Institute (NEI).

I apologize for the delay of this material and response. Please feel free to contact me on any issue of importance to you.  I am always happy to help.

Sincerely,

Frank A. LoBiondo
Member of Congress

FAL:pd

*

The enclosures, representing the "information that CRS looked at during its inquiry", consisted of

  • The article published by the LIGHT-ROP authors about their baby-blinding experiment in the May 28, 1998, issue of the New England Journal of Medicine under the title "Lack of Efficacy of Light Reduction in Preventing Retinopathy of Prematurity";

  • The editorial from the same issue of the NEJM: "Preventing Blindness in Premature Infants" by Arlene V. Drack;

  • A Policy Statement by the American Academy of Pediatrics, dated August, 1997, and titled "Screening Examination of Premature Infants for Retinopathy of Prematurity".

This was it.  There was no refutation or reaction whatsoever to any of my documented charges of gross ethics violations, and no sign that any investigation had taken place.  In other words, the Congressional Research Service had lied outright to a member of the very group it is supposed to serve.   

First it had told Congressman LoBiondo that it had performed the requested review and gave him its conclusion, but then was unable to produce evidence of that alleged review when he requested it. 

And demonstrating that there is no recourse against medical sovereignty, these alleged examiners of the alleged guardians got away with having lied so blatantly to a member of US Congress.

Continue here to the LIGHT-ROP Manual of Procedures, for direct evidence of the gross ethics violations that alarmed none of the alleged watchdogs.

 

 
 

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