retinopathy of prematurity.org :

 a documentation of patient-harming frauds in medical research

 

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ROP description
Eugenics against oxygen
Slandering oxygen
Oxygen study frauds  
Alleged study results
Later deaths
Futility and harm
Fluorescent ROP lamps
Damaging irradiance
Preemie vulnerabilities
Studies of light and ROP
Frauds in LIGHT-ROP
Coverup stonewalling

 

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Baby-blinding lights
LIGHT-ROP Manual
Macular degeneration
Preemie Pain
Parent Concerns

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Help for Victims?

Re-Tuskegee >>>

Bioethics LIGHT-ROP

Bioethics SUPPORT

Bioethics own violations

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

Avaaz Petition to WHO

 


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   The LIGHT-ROP study's violations against ethics and science

 

rank with those in Tuskegee and the Human Radiation Experiments

 
 

My letter to Professor Susan M. Reverby
Marion Butler McLean Professor in the History of Ideas and Professor of Women and Gender Studies,
Wellesley College, Wellesley, MA
  
by H. Peter Aleff, October 5, 2010

Dear Professor Reverby,

Please accept my congratulations for your discovery and revealing of the pre-Tuskegee syphilis study in Guatemala in which deceptive medical researchers had deliberately infected their unsuspecting patients. I am equally impressed with your success in “relaying your information to the proper authorities”, as webster.edu’s online article about Annie Marion MacLean describes the actions of the “sociologist erased from history” after whom your academic Marion Butler McLean chair appears to be named.  Although that almost-namesake exposed mainly abuses of often defenseless wage-earning women, you are certainly a worthy upholder of that otherwise underappreciated activist’s tradition by exposing abuses of captive patients in medical research.

Since you are also an expert in the history of nursing, I want to bring to your attention another medical research abuse of captive patients, this time in the study of premature babies. This abuse happened closer to home than Guatemala, it is much more recent than even the end of Tuskegee, and it was committed despite all the theoretical modern safeguards that are said to now prevent such maltreatment but that have all failed in this actual case.

The LIGHT-ROP study of premature-baby blinding began in July 1995 at three hospitals -- in Buffalo, NY, in Dallas, TX, and in San Antonio, TX, and it was published in the New England Journal of Medicine’s May 28, 1998, issue. It reports on a clinical trial of about 400 preemies whose doctors deliberately withheld their eye protection from the bright fluorescent nursery light which the study authors themselves had described in their grant applications at length as a well-known source of eye damage in many animal tests and as a likely culprit in the still continuing epidemic of preemie-blinding from retinopathy of prematurity (ROP).  

This epidemic had begun in the US just after the introduction of fluorescent lamps at the New York World Fair of 1938/39 and again broke out after the war in Europe and other industrial countries as those lamps became available there.  Virtually all fluorescent lamps emit a high spike of their radiation in the blue-violet wavelength of 435.8 nanometer. This falls right in the narrow region from 430 to 440 nm where Occupational Safety researchers found the typical mammalian retina to be most sensitive to damage from the so-called “blue-light hazard” which damages the retina with photochemical reactions.  The LIGHT-ROP authors were well aware of these facts and even cited in a different context my 1991 clinical paper “Baby-blinding retinopathy of prematurity and intensive care nursery lighting” (http://retinopathyofprematurity.org/Babyblindinglights01.htm )
in which I had documented the gross overdose of damage-weighted retinal irradiance the preemies were receiving, as well as some of the other dangers to their eyes.
They also knew that the still developing eyes of preemies are many times more vulnerable to any such injury than the much better protected eyes of adults.

The regulations on informed consent may require the disclosure of any such known risks, but no information about any of these serious eye damage risks well known to the authors was mentioned on the “informed consent” forms which they made the trusting parents sign when enrolling their child in the trial.

However, instead of simply not exposing the babies to this strongly suspected but easily avoided harm, these authors requested the participating nurseries to maintain their lighting levels at full brightness and forbade turning them down or off.  They even instructed the nursery staff to “actively discourage” the use of shading blankets which caring nurses and parents usually spread over the incubators to give the babies some relief from the relentless bright light.  The researchers explained that they wanted to obtain “the maximum stratification contrast” between their alleged “study” and “control” groups.

The difference between these groups was only alleged because the LIGHT-ROP authors deliberately rigged their trial to falsely exonerate the nursery lights from any role in the blinding.  Whereas the designers of Tuskegee and many of the other unethical studies of humans as guinea pigs may at least have been driven by their faith in the greater good for future patients to be derived from their advances of science, the LIGHT-ROP authors knowingly set out to prevent such an advance, acting as part of the often reflexive medical wagon-circling against admitting embarrassing errors and liabilities. They knew that the photochemical light damage they pretended to study was defined as resulting from exposures between 10 and 10,000 seconds which is less than three hours.  They were also aware that the typical nursery lighting exposes the still developing and therefore most vulnerable retinae of the preemies in less than 15 minutes to the dose of damage-weighted retinal irradiation which the Occupational Safety Guidelines had established as the danger limit for adult industrial workers. 

Yet, the LIGHT-ROP study designers delayed the eye-patching in both their groups until “up to 24 hours” after birth. They thereby knowingly over-exposed all the babies in both groups before those in the supposedly “protected” group got their eye patches. Predictably, both groups wound up with the same incidences of ROP.  This blatantly rigged wrong result is now prominently enshrined in the National Eye Institute’s description of ROP for patients which states in its section on “Current Research” that “The [LIGHT-ROP] study determined that light reduction in hospital nurseries has no effect on the development of ROP.” http://www.nei.nih.gov/health/rop/rop.asp#9   

This intentional overexposure of premature babies was going on when President Clinton offered in 1997, at your suggestion, his widely publicized apologies for the Tuskegee Study and for the equally infamous Human Radiation Experiments in which the researchers had also exposed unsuspecting victims to harmful radiation to see how badly this would harm them. And just as the Tuskegee doctors had withheld treatment and the doctors in the Guatemala study had intentionally maximized the exposure of their subjects to the harm they wanted to study, so the LIGHT-ROP doctors withheld protection  and intentionally maximized the exposure of the babies to the harmful radiation, and they did so right while the President’s well-meant promises of “never again” echoed around the world. 

Unfortunately, the medical community never got the memo about those “never again” promises because the regulations of the U.S. Office for Human Research Protections are to this day still worded so that the infamously patient-deceiving Tuskegee Study would again have to be approved without objections if the same protocol was re-submitted under a different name.

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, (which you listed as a sign of progress in your 2001 Postgraduate Medical Journal editorial Tuskegee: could it happen again?”), 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 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. 

Despite this obvious violation of common-sense ethics, their study protocol met the rather low standard of IRB-grade “medical research ethics” and got rubber-stamped by all the levels of grant-approvers at the National Eye Institute as well as by the institutional ethics review boards at the three study hospitals.

The so-called Office for Research Integrity saw nothing wrong with the LIGHT-ROP study either.  Their contact person for the 2006 World Conference on Research Integrity told me that “we will likely not have time to consider individual cases [of massive research fraud that keeps blinding babies around the world] in detail” but aimed mainly to “harmonize policies and communicate concerns [between countries]”.  So much for “research integrity” and “never again”.

Meanwhile, the deceptively rigged and baby-abusing but fully approved and by now authoritatively enshrined LIGHT-ROP study still contaminates the medical doctrine. Its false assertion about the alleged safety of fluorescent nursery lighting perpetuates the baby-blinding fluorescent intensive care nursery lighting in nurseries around the world, particularly with the current trend towards more energy-saving fluorescent lamps to replace any lingering old-fashioned and more eye-friendly incandescent bulbs.  The World Health Organization’s 1998 “Mission for Vision” stated that “ROP is occurring with increasing frequency in transitional economies” and identified ROP as “a leading cause of vision impairment in children in the developing world.” (As cited in 2006 at http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1856945/  

You will find a list of the several deceptions in the LIGHT-ROP study at http://retinopathyofprematurity.org/40fraudsinLIGHTROP.htm and extensive excerpts from its Manual of Procedures in the series of web pages that begins at http://retinopathyofprematurity.org/LIGHT_ROP_Manual01.htm.

And since you say near the end of your article for the Journal of Policy History about the Guatemala study that “Historians have the luxury to wallow in context and knowable facts”, I also recommend that you read my account of past ROP research at http://retinopathyofprematurity.org/01summary.htm which gives you the context of that revolting story and documents the relevant knowable facts in detail on the other web pages in that series.

These include the discussion of an earlier research fraud in the mid-1950s study that had wrongly blamed oxygen for the blinding.  That study’s knowingly false allegation that oxygen rationing had not harmed the babies killed from then on many thousands of oxygen-starved preemies.  This initially denied lethal effect of oxygen withholding was just recently reconfirmed in a study published this May where the mortality in the lower-oxygen-saturation group was significantly higher than in the group with more breathing help where more of the babies with eye damage survived. http://www.nejm.org/doi/full/10.1056/NEJMoa0911781

I hope that you will find the time to examine these “in vivo” examples of medical research misconduct which are hurting many preemies daily as you read this, and that you will be able to convince the relevant medical authorities that it is not enough to denounce only decades-old medical research abuses when newer ones are harming patients now. They may realize that continuing the current cover-up of these more recent research frauds will ultimately do more damage to the medical reputation than a speedy and already long overdue admission and correction of these deeply entrenched wrongs in their medical research culture.

Thank you in advance for your reply, and for anything you can do to help end the unnecessary blinding of many more hapless preemies each year.

Sincerely,

Peter Aleff

 
 

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