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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 "investigation" by the OPRR
Its sole question about the trial promoters' contradictions and omissions:    The watchdog lifts a sleepy eyelid

However, the OPRR did ask about Buffalo. On December 8, 1997, Dr. Susan L. Crandall, Acting Chief of the Compliance Branch in the OPRR's Division of Human Subject Protections, asked Dr. Putnam to clarify Dr. Reynolds' statement in his 8-11-97 letter that

"we did not alter nursery protocol at all (see enclosed nursery lighting protocol)."

since it apparently contradicted the LIGHT-ROP Manual.

The alleged nursery lighting protocol for Buffalo that Dr. Reynolds had enclosed with his reply, copy attached, differs indeed greatly from the LIGHT-ROP Manual that depicted both nurseries as having bright, round-the-clock lighting and did not allow the shading of the infants from the environmental light to be studied.

The alleged new protocol, by contrast, calls for light protection measures such as blankets to cover the isolettes and "lights off during specified quiet times".

Which of Dr. Reynolds' contradicting light protocols is to be believed?

Dr. Putnam passed that inquiry on to Dr. Reynolds who replied on December 19, 1997, to Dr. Crandall. He told her:

"We never tried to discourage it [the draping] at all" and "The MOP was written prior to negotiation with nursery nurses and physicians. The MOP does not reflect our actual practices 100%."

The first sentence is an undisguised lie since the LIGHT-ROP authors had repeatedly and insistently discouraged the draping of the incubators in their grant applications and in the Manual of Procedures (see my pages 227 and 228) that all the participating nurseries used.

As to the negotiation with the nursery physicians involved, these had long been settled if an earlier Dr. Reynolds is to be believed. He had assured his sponsors in June, 1994, on page 72 top of his "Revised Application":

"The participating neonatologists have agreed to maintain the current lighting practices at each center."

That leaves the nursery nurses. If these are the only ones who objected to the no-light-protection protocol in the LIGHT-ROP Manual of Procedures and thereby obliged him to change it so drastically, then the need for this last- ditch defense against his so objectionable procedures highlights the total and dangerous uselessness of the present bioethics system.

The harm-maximizing LIGHT-ROP protocol had been reviewed by the participating doctors and their consultants, by the IRBs in Buffalo and Dallas, by dozens of bioethicists and other "experts" at the National Eye Institute, by the Data and Safety Monitoring Committee, and so on.

All these "protectors of the public" fully and repeatedly approved the cruel maximizing of the babies' harmful exposure without the slightest question. If Dr. Reynolds is to be believed, then it took the resistance of the nursery nurses to this inhuman treatment to have the so patently unacceptable trial protocol changed at the last moment, literally from day to night.

If Dr. Reynolds thus admits now the initial protocol was so unacceptable that the nursery nurses insisted to have it changed so greatly, then why did the bioethics system stay asleep at the switch and fail to catch this harm-maximizing experiment?

Why was it left to the nurses, the lowest- ranking and most powerless members in the medical hierarchy, to refuse their co- operation with this cruelty?

What do all those ethically challenged IRB and NEI doctors with their pompous medical and bioethical titles get paid for?

And if the Manual of Procedures for the trial does not reflect the actual practices used during the trial, then which document, if any, reflects them?

Dr. Reynolds never told his grantors in his mandated progress reports a word about any departure from the agreed-upon protocol, nor did he inform the IRB about the purported change. This is a blatant violation of his obligations towards both the IRB and his grantor because the Multiple Project Assurance of Compliance with DHHS Regulations for Protection of Human Subjects forms from Buffalo and Dallas state both as their item IV.D. that

"Research investigators will promptly report proposed changes in previously approved human subject research activities to the IRB. The proposed changes will not be initiated without IRB review and approval, except where necessary to eliminate apparent immediate hazards to the subjects."

The Buffalo nursery's alleged new light-protecting nursery protocol is a radical departure from the lighting practices proposed and approved for the trial. It is unsigned but bears two typed approvals dated October 95 -- that is three months after the enrollment for the LIGHT-ROP study had begun in July 95.

Curiously, the alleged change never appears in any of the voluminous paperwork that tracks the trial -- until Dr. Reynolds suddenly produces it now to deflect the charges against his all too callous protocol.  The new policy reeks of fabrication, but the watchdogs did not follow the smell.

And if Dr. Reynolds did initiate the change without prior IRB review and approval because it was necessary to eliminate apparent immediate hazards to the babies, then would that admission not have rendered the whole idea of the LIGHT-ROP trial instantly obsolete?

The watchdog's eyelid drops back

These glaring discrepancies highlight the failure of the OPRR to even pretend that it is doing its job. If their investigation of my complaint had been more than a sham, they would at least have asked Dr. Reynolds to provide the light measurements and compliance check forms for the isolette- draping that he cites to support his allegations.

And if the OPRR people were at all serious, they would have interviewed some of the nurses and parents to find out what really happened. They would also have asked about the actual lighting conditions at the other study sites, particularly since one of the Progress Reports from San Antonio, submitted in January, 1997, specifically asserts that "No change in the protocol has been made."

Instead, the OPRR simply accepts Dr. Reynolds' questionable and question- raising alleged explanations and closes its bogus "investigation" which never took place.

Conclusion and plea

The case of the nursery lighting highlights many serious inadequacies in the government's supervision of medical research. The unquestioning approvals for running the protection- withholding and scientifically fraudulent LIGHT-ROP trial, followed by the arrogant medical cover-up of the ethical lapses in it, demonstrate that the public has still no functioning safeguards against gross and people- harming abuses in medical research.

This country is founded on a system of checks and balances for political power, and despite its various shortcomings, that system works better than the others that have been tried so far. So why not use the same system of external and independent controls to balance the enormous and now entirely unchecked power of the medical profession?

Presently, nothing prevents medical experimenters from relapsing at will into their traditional unethical and patient- harming experiments on unsuspecting people

Even worse, the government itself supports the medical establishment's chronically uncritical promotion of a few medical bigwig's personal prejudices as authoritative science, and then it helps to cover up the medical atrocities that result from the unexamined medical beliefs in those absurdities.

Is this how you want this country's system for protecting people from medical abuses to continue? Or do you think it is time to put a leash on this rampaging behemoth, an effective system of checks and balances?

And would you like to become known as the monster- taming hero who domesticated this difficult and dangerous beast so that it could become a help to people instead of a threat to their health?

I thank you again for your continued efforts in besieging the medical stonewall, and I look forward with great interest to hearing from you. In the meantime, I remain

sincerely,  
H. Peter Aleff
cc: Paul Doell

P.S.: I am further enclosing a letter I wrote recently to Professor Stephen Jay Gould, the new President of the American Association for the Advancement of Science, in which I ask him to provide a panel of non- medical scientists who can make an independent evaluation of the evidence I present. May I suggest you write to him, too, and support my request to give you expert witnesses for the hearings I hope you will soon be able to hold?

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