retinopathy of prematurity.org :
a documentation of patient-harming frauds in medical research
The study-authors' own words
show their gross ethics violations
Letter dated October 23,1989, from Rand Spencer, M.D., at Baylor University Medical Center in Dallas, Texas, on stationary of "LIGHT-ROP: A Study of the Effects of Light Reduction on Retinopathy of Prematurity", to
Mr. Bill Sardi at
I certainly appreciate your letter of October 18 and your interest in the question of light possibly exacerbating retinopathy of prematurity. The status of our study into this question is that a Grant Proposal for a Planning Grant has been submitted to the National Eye Institute for funding for the actual study of this question. At this time, there is no study underway but we are in the formative stages of study design. One of our major objectives is to design a study which would stand the least possible chance of ruling out light as a factor in the development of significant ROP if it indeed does truly have an effect. I greatly appreciate the information which you sent and your admonitions regarding short wave length light emissions from fluorescent lamps and the question of diurnal effect of light on the retina. These are all questions which we will be addressing in the design of our study. Thank you for your interest. If I may provide you with any further information regarding our work in this area, please do not hesitate to be in touch with me.
Baylor University Medical Center
Letter dated September 26, 1994, from James D. Reynolds, M.D., at the Children's Hospital of Buffalo, Pediatric Ophthalmology,
Dear Dr. Mariani:
Our Light-Rop revised grant application, 1010EY09953-01, is to be reviewed by study section in October. We wanted to submit a brief supplement to our application.
As you know we have resubmitted this grant after consultation with NEI officials. We have refocused our work to represent a feasibility study with only two study centers rather than the more ambitious multi-center trial. This smaller number of patients will provide adequate preliminary data that will be used to determine further study. Positive results would support a larger trial.
with the potential for a major impact on ROP. But even a negative result would be extremely useful in ending a long scientific and public debate.
This feasibility trial should give us relatively rapid assessment of the usefulness of our proposal. It can achieve this relatively inexpensively.
However despite extra expenses, we have reconsidered our need for a Data and Safety Monitoring Committee. We will be randomizing patients and feel we should have a DSMC. I have included our suggestions along with an anticipated expense which Dr. Hardy has put together.
Finally, we have conducted an ERG study on our goggled babies to assess safety, ERG'S have been analyzed for 37 patients. We found no differences between goggled babies and controls in mean rod threshold, cone threshold, or peak amplitude.
We are hopeful you will agree with the usefulness of this feasibility study and that eventually this question can be answered definitively.
James D. Reynolds, M.D.
cc; Don Everett, M.A.
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