retinopathy of :    

 a documentation of patient-harming frauds in medical research

Abstract & Summary

Table of Contents
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


Related items

Protect your baby
Baby-blinding lights
Macular degeneration
Preemie Pain
Parent Concerns

Skeptics' Test

Help for Victims?


Bioethics LIGHT-ROP

Bioethics SUPPORT

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


TV transcripts
on baby-blinding

Good Morning America
CBC Market Place
USA Today


Print coverage
The New York Times

Parade Magazine >>>


About us



Preemies go blind from nursery lights


 and doctors deny the harm 



From the Parade Sunday Magazine
issue of June 1, 1997,  cover and pages 4 to 6  

Part 1 of  Can Light be Dangerous for Babies?
by Bernard Gavzer, cover photograph by David Moser
Why are hundreds of very premature babies going blind each year?   Experts suspect a hazardous condition in the intensive-care nurseries.

KATIE WATSON was so tiny the day she was born in 1989, her father could practically hold her in the palm of his hand.  Katie weighed just 2 pounds 3 ounces.  She was three months premature. Within 15 minutes of her birth, she was whisked away to the intensive-care nursery of a Madison, Wis., hospital.
Katie's parents waited nervously for the next three months. The pediatricians
used their considerable skills to keep Katie alive, and she was on her way to recovery when doctors noticed that her retinas were damaged.
Ophthalmologists quickly performed surgery to try to save her sight. But it was already too late.  By the time she got home, Katie was irreparably blind.
'You have all kinds of emotions," said Margaret Watson, Katie's mother. "But what tears at you is that you just don't know how it could happen. You ask yourself, 'Is there something I did wrong?'"
Katie was one of thousands of very low birth weight babies believed to have gone blind while in a hospital's intensive-care nursery. Their loss of sight is the result of retinopathy of prematurity (ROP), a common disease among premature babies in which the immature blood vessels in the eye seem to grow wildly.

Dr. James D. Reynolds, director of the National Eye Institute's Light- ROP study

"If any chance existed that ambient light was damaging, we wanted an opportunity to prove it to the largely skeptical world. Our trial is the only way this will be accomplished."

In most cases, the disease is self-correcting before any lasting damage occurs, though some children develop eye problems as a result. Babies born at least three months
prematurely are particularly vulnerable.
In severe cases, the leaking blood vessels can cause swelling and scarring of the retina. Without firm anchoring, the retina may then detach from the back of the eye, resulting in blindness.  An estimated 600 babies in the U.S. lose their sight to the disease each year. Others suffer some loss of vision.
Are the bright, fluorescent lights in hospital nurseries responsible?
Parents like Margaret Watson are convinced they are.  For years, she and other parents of children with ROP have urged hospitals to stop using the lights or to shield them with filters, arguing that they are not necessary and may have damaged their children's eyes.
But ophthalmologists are divided. Though some small studies have suggested a link between exposure to fluorescent lights and the disease, others have found no such evidence; critics on both sides say these studies were scientifically flawed and inconclusive.
Now, in the largest federally financed study on ROP ever -- conducted by the National Eye Institute -- researchers hope to determine if there is a link between hospital nursery lighting and this condition.
The results may not be known for at least a year.  But the Light ROP study, as it is called, already has drawn heat from parents who say the findings may come too late for the thousands of premature babies already in hospitals.
One parent's crusade:  H. Peter Aleff  -- a Vineland, N.J., engineer and inventor whose son, David, went blind from ROP in 1984 -- has led the fight against fluorescent lighting in neonatal units for nearly a decade. 
He has sent 200 letters to hospitals, advisory committees and government agencies. Most have been met with a polite response and then silence, be said.  One doctor informed Aleff through his attorney that he would no longer open mail from him.
Aleff detailed his evidence in a self- published book: The Medical Ethics Trap Behind Retinopathy of Prematurity and Much Cerebral Palsy.  He said he became convinced of a link between fluorescent
lights and ROP when he worked as a manager in glue and ink factories. Both visible and ultraviolet lights were used, and workers needed protective eyewear. 

"That is how I learned about the blue- light hazard to the retina." be said.
Aleff was referring to some animal studies which have shown that exposure to light in this spectrum (435 to 440 nanometers) can damage retinal blood vessels. The fluorescent tubes found in many hospital nurseries concentrate blue-violet rays, he said, posing a risk to the underdeveloped eyes of preemies.  (Full-term babies are not thought to be at risk because their retinal blood vessels have had a chance to mature.)
"The fact is that ROP did not exist until the widespread use of fluorescent lighting about 50 years ago," Aleff told me.  It was not until the post-war period that hospitals began using the lights, be said.
Before then, some isolated cases of ROP were diagnosed. By 1953, however, doctors had diagnosed an estimated 5000 cases in the U.S.
At the time, it was thought that the eye damage may have resulted from excessive amounts of oxygen given to premature babies. But a clinical trial in the 1950s, in which oxygen supplements were withheld, led to brain damage and in some
instances death among preemies.
Today, oxygen levels are monitored more accurately, and researchers are looking for other clues to what triggers ROP. To Aleff, the evidence is already clear that fluorescent lights are to blame. "Why do we need another study?" he asked.
He called the Light-ROP study "pseudo-science of the most flagrant kind."  He insisted it is scientifically flawed and unethical, arguing that the risks of fluorescent lighting far outweighed the benefits.

In a complaint filed with the National Bioethics Advisory
Commission, Aleff alleged that prospective volunteers were asked to sign a misleading consent form that failed to notify them of their babies' risks from fluorescent lighting, compromising assurances about the safety of the study.
How the study works: The Light ROP study was started in July 1995 at three hospitals -- one in Buffalo, N.Y., the others in Dallas and San Antonio, Tex.

About 200 preemies were fitted with specialized goggles to reduce their exposure to light within 24 hours after birth. An equal number of premature babies were observed under standard nursery lighting.  The patient-recruitment phase of the trial ended this March.
Scientists are now examining the babies and will evaluate the data, comparing the two groups to see if there is a higher incidence of ROP in either one. "We simply do not know at this time whether ambient light is good, bad or neutral to the ROP disease process," said Dr. James D. Reynolds, chief of pediatric ophthalmology at The Children's Hospital in Buffalo and the director of the study.
Dr. Reynolds faced a tough fight to get funds for the study. He was turned down twice by the National Eye Institute (NEI) for "lack of convincing scientific rationale" before the agency finally put up $750,000.
"If any chance existed that ambient light was damaging, we wanted an opportunity to prove it to the largely skeptical world," he said. "Our trial is the only way this will be accomplished."
But critics like Margaret Watson contend the study's results will be flawed. Watson said the babies with goggles were exposed to harmful light rays for as much as 24 hours before being fitted; the damage may occur in a matter of minutes, so the goggled group may have as high an incidence of ROP as the unshielded babies.
But some waiting time following birth was necessary, said Dr. Carl Kupfer, director of the NEI.  Expectant mothers going into labor well before their due date usually come into the hospital under emergency conditions, he explained. The doctor's goal is to stop the contractions and prevent a premature birth; there is little, if any, time to ask the mother or father for consent to a study.
Margaret Watson disagreed. "I was in the hospital 12 hours before I gave birth, and I would have had plenty of time to consider the proposal of a study," she said.



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