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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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The letters in this series of web pages document the further mishandling of my complaint about medical abuses as it made its way through the government system that is alleged to protect the public from these very violations. 

The fact that my complaint got through that system at all is due to the repeated interventions of  US Congressman Frank A. LoBiondo who represents my district.  He and his staff were very helpful and made many efforts to keep the case moving, but even they were unable to make those supposed protectors of the public perform their mandated job.

Here is one of my letters to him in which I describe the outcome of the alleged inquiry into my complaint, followed by his further attempts to obtain answers, and the final  refusal of the bioethics system to account for its inactions:
 
To:  The Honorable Frank A. LoBiondo
United States House of Representatives
222 Cannon House Office Building Washington, DC 20515-3002

 
March 20, 1998

Dear Mr. LoBiondo:

Paul Doell sent me the 14 lbs of paper that the Office for Protection from Research Risks had released to you about their handling of my complaint, and I want to thank you for your kind intervention to obtain this material. Your idea to request it was brilliant because the paper trail of this "investigation" demonstrates now for all to see that the OPRR is a kangaroo court which did not even pretend to look seriously into my charges and warnings.

Moreover, the way the OPRR's criteria for approval of medical research are currently set up, the Internal Review Boards (IRBs) would still have to rubber-stamp the Tuskeegee study protocol if some researcher submitted it today.  If this case is any guide, the public will be better off without that dangerous illusion of non- existing protections against the chronical abuses of ethics-blind medical experimenters.

Let me briefly discuss the few items of substance in the stack of paper the OPRR sent you. Most of the almost 2000 sheets are just dunnage copies. I extracted about two dozen pages and attached them to this letter behind the sheet that lists them, together with a few other enclosures.

These few pages are all the actual inquiries and responses with the relevant portions of their support documents, and even these include some duplications and much rehash of often repeated and long refuted medical assertions.

The OPRR pronounced its verdict
before the investigation started

The OPRR's parody of an investigation into the intensive care nursery abuses began two days after last year's June 1 PARADE article had brought my March 24 complaint to public attention. On June 3, a memo by "marianne" (presumably Marianne M. Bentz, M.S.N., Chief of the Compliance Oversight Branch in the Division of Human Subject Protections at the OPRR) to "Joe" (probably Dr. Joseph S. Cassells, Adjunct Medical Officer in that same Division of Human Subject Protections) instructed the latter to ask the research sites the standard questions and "at least" a narrowed-down part of one of my complaints about the inadequacies of the consent form. Then that memo adds in parentheses a "talking-point"-style suggestion that reveals the OPRR's predetermined conclusion for the investigation to be held: "it is just a given that there will be bright lights."

This inappropriate, biased, and also plain wrong suggestion highlights an obvious flaw in the system: How honest can this alleged investigation be if the judge is allowed to coach the investigator with her pre-ordained decision? And how trustworthy can the public's protection against unethical medical experimenters be if the government tolerates that the alleged protectors side so openly with the experimenters?

The "bioethics" system suppresses
most of my charges from the start

The next action was Dr. Cassells' letter of June 30 to Dr. Perrie M. Adams, Associate Dean of Research and Chairman of the Internal Review Board at the University of Texas Southwestern Medical Center. Three weeks later, on July 21, Dr. Cassells sent the same letter also to Dr. Putnam, the Co-Chairman of the IRB at the Children's Hospital of Buffalo. He never even bothered to contact the other two study sites, San Antonio and Santa Rosa, which I had also named in the complaint.

Moreover, Dr. Cassells asked for answers to only two of my many charges as the only ones that fall within OPRR's mandate:

  1. that there are no benefits from the nursery lighting that would justify the substantial risks from it, and

  2. that the consent form concealed from the parents the risks of fluorescent light which were known to the researchers.

The OPRR is supposed to protect people from the risks arising out of medical research. Yet, it omitted to address my detailed documentation of the scientific fraud in the timing of the eye protection that rigs the LIGHT-ROP study, although the intentionally misleading result obtained through this rigging will expose many babies to unneeded risks caused by this bogus research.

The OPRR did also not react to the risks from the present standard nursery lighting which is maintained because a similar scientific fraud in prior research masked these risks and introduced a deceptive prevention strategy that still harms many babies.

Nor did the OPRR do anything about the parent-deceiving lies about oxygen on the consent form that stem from the same fraud in prior research and that also still increase the risks to the babies.

Please note that the Health Research Extension Act of 1985, Public Law 99-158, Section 491.(a)(2), directed the Secretary of Health and Human Services to

"... establish a process for the prompt and appropriate response to information provided to the Director of NIH respecting incidences of violations of the rights of human subjects for research for which funds have been made available under this Act."

This Public Law may be on the books, but the Secretary of HHS herself did not comply with it, nor did the Directors of her Department's relevant medical Institutes, as shown by my unanswered correspondence with them that I listed on pages xiii to xv of the Table of Contents for my "Medical Ethics Trap ..." book.  The OPRR is clearly disobeying that law, too, with its sluggish and prejudiced reaction.

In addition, the National Bioethics Advisory Commission had transmitted my entire complaint to the OPRR and felt no need to address those charges for which the OPRR claims to have no mandate. If that claim were true, then the Commission should have dealt with the items left open or at least should have passed them on to some other agency charged with looking into the parts of my complaint not covered by the OPRR.

As you know, President Clinton had created that Commission explicitly so that people would have someone to turn to with their complaints, yet right away those bioethical advisors let major parts of my complaint fall through the cracks. It seems they were too busy with Dolly the single cloned sheep to have time for thousands of human babies. There is clearly a major variance between the shining Dr. Jekyll image projected by the President and the unchanged ugly Mr. Hyde reality that hides behind the benevolent mask.

Why should people trust a bioethics system of protection from research risks that ignores such documented recklessness about patient risks and patient-harming fraud in biomedical research, plus lies in the consent forms, as not within its hairsplittingly narrow mandate? And do you think the government should pay for such harmful fraud against the public?

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