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Bioethics LIGHT-ROP>>>

Bioethics SUPPORT

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Bioethics Consent

Bioethics 1955 Oxygen

Unethical Bioethics 1

Unethical Bioethics 2

Unethical Bioethics 3

Unethical Bioethics 4

Hypocritical Nature

False Medical Denials

Pre-Nuremberg Bioethics

Protect Humans in Research

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 Baby-harming medical research

 

to falsely deny preemie blinding from nursery lights

 
 


My open letter to Professor Amy Gutmann
University of Pennsylvania President and
Christopher H. Browne Distinguished Professor of Political Science &
Chair of the Presidential Commission for the Study of Bioethical Issues

From: Peter Aleff <prevent at retinopathyofprematurity.org>

Subject: Recent patient abuses in US medical research on premature babies
Date:
Sat,
27 Nov 2010 16:25:34 -0500
To:
<info@bioethics.gov>

Dear Dr. Gutmann,

Following recent headlines such as CNN's "Obama requests review of U.S. research regulations", and President Obama's request to your commission to form a panel this coming January to review existing regulations for the protection of patients in medical research, I want to bring to your attention that the abuses of inflicting deliberate harm on unsuspecting and defenseless patients are not safely limited to long past studies, like the recently revealed syphilis study in Guatemala, or the equally infamous Tuskegee study of that disease's evolution in untreated black men.

There is at least one much more recent example in US pediatric research that followed a protocol of deliberately exposing research subjects to intentional harm very similar to that used in Guatemala. In the LIGHT-ROP study of baby-blinding by excess light, published in the May 28, 1998, issue of the New England Journal of Medicine, US medical researchers financed by the National Eye Institute exposed premature babies knowingly to the blue-violet spikes in fluorescent nursery light which they themselves had described as eye-damaging and as a potential cause of the baby-blinding retinopathy of prematurity epidemic.

Even worse, these inhumane researchers intentionally maximized the babies' exposure to this potentially dangerous irradiation by forbidding the nursery staff in the three study hospitals to grant the babies the customary protection from the overly bright fluorescent light which caring nurses and parents usually arrange by shading the babies from the harsh illumination with blankets spread over their isolettes. The reason the trial designers gave in their Manual of Procedures for this cruel mistreatment of human babies was that they wanted to "increase the stratification and contrast of the test results", as if those babies were disposable guinea pigs.

You will find a description of this abuse at http://retinopathyofprematurity.org/Re-Tuskegee.htm

where I posted my open letter to Professor Reverby, the Historian who had discovered the documents describing the abuses in Guatemala. In that letter, I further describe the indifference of the relevant US government agencies to this blatant and overt abuse, and I show that, incredible as this may seem to lay observers after the prominent official condemnations of the Tuskegee Study and of the Human Radiation Experiments, the U.S. medical research rules still do not require the protection of research subjects from known existing dangers. Despite the revision of the Helsinki Declarations forbidding the use of placebos when real treatments exist, US researchers still have to protect their patients only from those dangers that are created by the research itself. Indeed, the "Criteria for IRB approval of research" state explicitly in Section 45 CFR 46.111 (2):

"In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research)".
http://cfr.vlex.com/vid/46-111-criteria-irb-approval-research-19931875

Just like the doctors running the textbook-unethical Tuskegee Study who did not introduce new risks to their subjects, the LIGHT-ROP authors failed to protect their patients from the well known danger that they pretended to study. Even worse, they strove Guatemala-style to maximize the harmful exposure of the unprotected babies to enhance the "contrast" and thus credibility of their study results, casually sacrificing those babies' eyesight to their pretended "science". Yet, they did not introduce a new risk, they only maintained and increased an existing one.

Accordingly, despite this obvious violation of common-sense ethics, their study protocol met the rather low standard of IRB-grade "medical research ethics" and was fully approved at all the layers of alleged safeguards against such violations of patients rights and of common ethics.

The details of this abuse are documented in the study authors' own words in their Manual of Procedures from which I posted extensive excerpts in the series of pages that begins at http://retinopathyofprematurity.org/LIGHT_ROP_Manual01.htm

Moreover, this study was thoroughly unethical on yet another level because it was intentionally designed to falsely deny the role of the current nursery lighting in the ROP baby- blinding epidemic. That epidemic began in the US with the introduction of fluorescent lamps, and started a few years later also in other countries as these lamps became available there. The pre-arranged false-negative finding of the LIGHT-ROP study now prolongs the baby-blinding which continues the steady stream of customers for the pediatric retinal surgeons among its authors. It also protects many other members of the medical profession from having to admit their liability for the continued blinding and other permanent harm to the babies.

You will find more background information about this epidemic at http://retinopathyofprematurity.org/01summary.htm, including a discussion of an earlier bogus study in the mid-1950s that deliberately killed many of the babies by withholding the life-saving oxygen breathing help so that there would be less cases of blindness among the survivors of this Draconian mistreatment.

Others and I have tried for over three decades to bring these abuses to the attention of the relevant medical authorities but have so far not penetrated the stonewalling and wagon-circling with which these protect the medical profession against any hint of such consistent wrongdoing.

I hope therefore that your panel for the study of patient abuses in medical research will be more serious about its task than, for instance, the 1994-1995 Advisory Committee on Human Radiation Experiments which issued a lengthy report volume brimming with the mandatory "never again" rhetoric but changed nothing in the system that had allowed these abuses and continues to allow them.

I am asking you for your kind permission to share your reaction to this alert with others around the world who are also interested in ending this epidemic as well as other patient abuses, and I thank you in advance for your reply.

Sincerely,
Peter Aleff

Reply received from the Commission:

101220 bioethics reply

 

My follow-up email of March 14, 2011,
to the earlier correspondence posted above:

To the Presidential Commission for the Study of Bioethical Issues

On November 27, 2010, I alerted your Commission to the patient abuses and scientific fraud in the 1998 LIGHT-ROP clinical study of blinding premature American babies, as posted at http://retinopathyofprematurity.org/BioethicsLIGHT-ROP.htm.
 
In that study, the researchers knowingly patched the eyes of
their allegedly light-protected group much too late to make any
difference in the babies' exposure to the excess blue-light hazard from the fluorescent nursery lighting which damages their retinae in much shorter exposure times. This fraud exonerated the nursery doctors from having to admit their responsibility for inflicting the eye damage with the lamps their Academy of Pediatrics specified, and it kept those baby-blinding fluorescent nursery lamps shining.
 
This bogus result also allowed the nursery doctors to continue their lethal as well as brain-damaging oxygen rationing that accounts for a significant portion of the costs and profits in an intensive care nursery and that leads to knowingly baby-killing oxygen-withholding trials like the recent SUPPORT study I
described to you in my email of February 22, as posted at
http://retinopathyofprematurity.org/BioethicsSUPPORT.htm and at
http://retinopathyofprematurity.org/Bioethics1955oxygen.htm.    
 
In that 11/27/2010 email and in the more detailed pages linked to it I had documented to your Commission that the continued overexposure of the preemies' still developing and therefore most vulnerable eyes to the intense energy spike of those fluorescent nursery lamps in the most retina-damaging wavelength is clearly the obvious cause for the continuing world-wide epidemic of baby-blinding retinopathy of prematurity, or ROP.
 
For instance, the ROP epidemic started here with the introduction of fluorescent lamps in the US in 1938/39 and began a few years later in Europe and other industrial countries as these lamps became available there after the second World War. Also, the typical intensive care nursery lighting exposes fragile preemie eyes in a few minutes to more damage-weighted retinal irradiance than the US Industrial Safety Guidelines have established as the danger limit for adult workers in an eight-hour work shift. More evidence is listed on the series of pages that begins with
http://retinopathyofprematurity.org/Babyblindinglights01.htm

Meanwhile, the ROP epidemic still ravages intensive care nurseries around the world today and is one of the major causes of childhood blindness in most developed and developing countries.
 
Valerie H. Bonham, your Commission's Executive Director, thanked me on December 20 for my comments and said you would welcome my continued engagement and feedback, so here it is:
 
My material showed to your Commission that you could end that
ROP-blinding virtually overnight by exposing the blatant
research fraud in the LIGHT-ROP study which now prevents
nursery doctors around the world from using common sense to
protect the eyes of all preemies from the clearly hazardous
fluorescent irradiation.
 
The above facts are unrefuted and undisputed by honest scientists. It is therefore your Commission's ethical duty to stop this unnecessary blinding and to save the eyesight of many thousand children a year, or several hundred every month. This is in your Commission's power because all you need to do is to alert the public to the scientific facts, and the nursery doctors will have no choice but to quickly protect the preemies' eyes.
 
Nursery doctors all around the world have traditionally accepted and followed US research results and intensive care nursery routines, as they did with the bogus recommendations for oxygen withholding to allegedly prevent blinding. You have now the chance to replace those disastrously harmful American teachings with a simple way to end the entire ROP epidemic.
 
You could thereby make up to the rest of the world, at least in part, for some of the damage the oxygen withholding doctrine has done in all the other countries where doctors misled by yet another unethical US study had blindly accepted that falsely promoted eugenics-inspired baby-eliminating doctrine.
 
Yet, your Commission has kept this well documented information for now over three months locked up in its ivory tower and has so far done nothing to protect preemies from the continuing abuse of their vulnerable eyes in today's overbright intensive care nurseries.
 
I realize that your Commission's assignment is not to stop research abuses but only to study them and the possibility of their still occurring today, and then to write a report on your findings. This narrow view may allow your members to try and use the Nuremberg defense that they only did what they were told to do, but this unethical refusal to prevent an imminent harm may not be deemed acceptable from bioethicists who keep condemning the very similar ethics violations in Tuskegee.
 
Indeed, if your Bioethics Commission's failed to protect a vulnerable population against a known hazard that you could easily stop and prevent from harming more children, then how, pray tell, would this failure be different from the infamous failure of the Tuskegee doctors to stop the syphilis of their study subjects when they could easily cure it?
 
If anything, should your Commission omit to quickly end the baby-blinding then it would rank even worse on that scale because the Tuskegee doctors were at least not responsible for injuring additional people beyond those who did already have the disease. Your Bioethics Commission, by contrast, knowingly lets several more babies' eyes be destroyed every day that you further delay your already long overdue epidemic-ending intervention, and it exposes several more preemies a day to the risks of death and brain damage from the misled oxygen withholding.
 
Since one of your Commission's tasks is to compare US laws and regulations about patient protection in medical research to those of other countries, I want to draw your attention to the so-called "Good Samaritan" or "abstain from helping" laws that are popular in Europe and possibly elsewhere, too.

One of these is the French legal concept of "abstention volontaire de porter assistance à une personne en péril". Under article 223-6 of the French penal code, each of your Commission's members could be sued by any parent or other agent of a preemie born in France and blinded by ROP during your Commission's inaction to stop the world-wide blinding although it was able to do so. They would be criminally liable if they knew about the preemies' imminent peril of bodily harm and if they could have prevented that harm without risk to themselves. In France, this crime of omission is punishable with five years in jail plus a fine of 75,000 Euros
http://fr.wikipedia.org/wiki/Non-assistance_%C3%A0_personne_en_danger .
 
Germany has equivalent laws about "Unterlassene Hilfeleistung", and so do Albania, Austria, Belgium, Bulgaria, Croatia, Czech Republic, Denmark, Finland, Greece, Hungary, Iceland, Italy, the Netherlands, Norway, Portugal, Russia, Serbia, Spain, and Switzerland, plus possibly some other countries not mentioned in this Eurocentric list from http://en.wikipedia.org/wiki/Duty_to_rescue .

You might therefore need to advise your members to be cautious about the risk of getting arrested during future travels to those countries unless your Commission stops the international baby-blinding with due diligence to prevent more harm.
 
I further suggest that you consider how you could explain any continued Tuskegee-style inaction on your Commission's part to the parents of the American preemies getting blinded now when these facts become public knowledge. Ultimately, the truth is bound to come out, as it did for some of the initially secret medical atrocities committed by others that your Commission now studies.
 
I ask you therefore to please protect the preemies of the world now from retina-destroying nursery lamps and from lethal or brain-damaging oxygen-withholding. You would thereby help to redeem the moral liability of American medical research for some of its past ethics breaches that harmed not only its research subjects but that also keep harming many innocent preemies around the world.
 
Respectfully submitted,
Peter Aleff
prevent@retinopathyofprematurity.org

Continue here to the complaint about the 2010 SUPPORT study 
 

 
 

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