retinopathy of prematurity.org :
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certified letter of January 31, 1993, to
According to Black's Law Dictionary, informed consent must be based on a full disclosure of all the known and suspected risks for each alternative treatment or lack thereof. Since you have a fiduciary duty towards all enrollees to be fully aware of the risks to which you are exposing them, I am sending you enclosed a copy of my clinical paper "Baby-blinding retinopathy of prematurity and intensive care nursery lighting" which summarizes the evidence for risks to the babies' eyes from light.
According to your grant application, even the "protected" group in your study may obtain this protection only up to 24 hours after birth; as I show in my paper, it takes less than 15 minutes for typical nursery lighting to expose the extremely vulnerable eyes of a premature baby to the dose of retinal irradiance which the occupational safety guidelines warn against as the danger limit for healthy adult workers.
The parental consent form should state not only the reason for and benefits to be derived from such intended exposure but also all the known and suspected risks. I would therefore appreciate it if you could make this paper also available to the other members of your study's Data and Safety Monitoring Committee.
Your study proposal states that you and they will be responsible for reviewing the ethical conduct of the study, so they would most likely share with you also the legal consequences if information about documented risks were to be withheld from parents of patients enrolled in your study.
Thank you in advance for your cooperation. I remain
sincerely, H. Peter Aleff
Reply received from Dr. Spencer, dated March 27, 1993, on stationary headed "LIGHT-ROP, A Study of the Effects of Light Reduction on Retinopathy of Prematurity", with these addresses in the footer:
Dear Mr. Aleff:
Thank you for you letter of January 31,1993 and your article regarding light and ROP in latrogenics, April-June, 1991. I know you have been interested in the relationship between light and ROP for many years, as have I. I have admired your fervor and tenacity on this subject and I would like to bring you up to date on the work our group is doing as it pertains to the LIGHT-ROP Study.
First of all, regardless of each of our personal opinions, there is still a defacto question existing as to whether or not light has any effect on the development of ROP. This is evidenced by the fact that (with rare exception), nursery protocol for care of premature infants in the United States and elsewhere in the world today does not call for reduced light exposure to the eyes of premature infants for the prevention of ROP.
Whether or not it should is a point that most neonatologists feel is not answered well enough to take the risks to the infant which light shielding entails. These risks include lack of sufficient room light to observe subtle changes in infant's skin color and possibly even the production of light deprivation amblyopia early in the critical period of visual development.
No one fully knows the risks of decreasing light exposure since "normal room-light" levels have been the standard until now. Although reducing light to the eyes certainly seems harmless, so did giving supplemental oxygen to keep these infants alive in 1940.
As you very eloquently document in your article in Iatrogenics, there are many theoretical reasons to believe that light exposure to the developing retina of a premature infant may have a detrimental effect and lead to ROP. Nonetheless, the clinical studies of this question have not confirmed these suspicions in a convincing manner. Despite Dr. Glass' positive result published in the New England Journal of Medicine in 1985, subsequent reports by Ackerman* and Seiberth** have failed to show any relationship.
Although the work by Seiberth has not been published in its entirety in a refereed journal, the results of this German study were reported as a poster at both the American Academy of Ophthalmology meeting in 1991 and the meeting of the Association for Research and Vision in Ophthalmology in 1992. In my opinion, the design of this study was the best to date in that all infants weighing less than 1500 grams at birth were prospectively randomized to either have their eyes patched from birth until 35 weeks of gestational age or to receive routine nursery care. In Seiberth's study there was no decrease in the incidence or severity of ROP in the occluded group as compared with the control group.
It is my desire once and for all to try to answer the question of whether or not light exacerbates ROP development by designing and carrying-out a dinical trial for this purpose. Of course, paramount in the design of this study must be the safety of the participants which includes a suitable informed consent. At this time there is no ongoing work studying the effects of light on ROP. The proposal that our group sent to the National Eye Institute in January, 1992, was approved but not funded. We are in the process of revising our application and resubmitting this to NEI for further funding consideration.
I shall not give you all the details of the design of our proposed study however a general abstract is as follows. Infants weighing <1251 grams at birth will be eligible for randomization within 24 hours of birth to either routine nursery care (as regards shielding of the eyes from ambient light) or to wear light reducing goggles.
The goggles contain filters which screen all light <400nm. and approximately 97% of visible light between 400 and 650 nm. These goggles will be worn until 31 weeks of gestational age at which time the goggles will be removed and routine ROP screening exams will begin for all infants.
By comparing the incidence of ROP in the goggled group with that in the control group we plan to answer the question of whether or not light is having an effect on this terrible disease. Finally, please be assured that under no circumstances will any child in this study ever be exposed to increased amounts of light, nor will the study in any way dictate what the lighting conditions (either bright or dark) are to be maintained in participating nurseries.
[Note : Compare this false promise with the actual instructions to the study personnel in the Manual of Procedures for the LIGHT-ROP study posted here.]
You point out in your letter that even in our "protected" group the light reduction may not begin for up to 24 hours after birth. This is an issue in the design of the study which we have examined and re-examined in an effort to try to start light reduction in the goggled group as soon as possible after birth. The delay is due to the time during which it is necessary to contact the parents of each child and obtain an informed consent. During the time between birth and entry into the study, the infants will be cared for in whatever way is routine for the participating nursery.
I hope this information will help clarify the position of our group in the design and intent of the LIGHT-ROP Study. Please do not hesitate to be in touch with me if I may provide any further information to you in the future.
My reply of April 25,1993, sent to Dr. Rand Spencer by certified mail
Dear Dr. Spencer:
Thank you for your letter of March 27. You say there is still a de facto question whether light has any effect on the development of ROP. On the other hand, you wrote in your application for the LIGHT-ROP planning grant that you "believe there are compelling reasons to believe that light may play a role in exacerbating ROP", and that "no plausible basis exists for expecting harm from occluding the babies".
Where is the question that would justify exposing babies to light that you believe may exacerbate the destruction of their eyes?
I also do not follow your reasoning when you continue: "This is evidenced by the fact that (with rare exception), nursery protocol for care of premature infants in the United States and elsewhere in the world today does not call for reduced light exposure to the eyes of premature infants for the prevention of ROP." To me, this indicates only that the doctrine which is the basis for nursery protocols is essentially the same for practically all physicians involved with preemies, and that it ignores the scientific findings from the wide world beyond the narrow confines of this doctrine.
Its being followed by a large group does not imply that the doctrine is right -- or would you say that last century's obstetricians were right to kill their patients with childbed fever, just because they did not question their practice to not wash their hands?
Concerning the alleged risks from reducing light exposure, I refer you again to your own statements in your grant application. Please find enclosed a copy of a letter I just wrote to U.S. Senator Russ Feingold in which I discuss the ethics of that proposed trial in detail. I would appreciate your comments on that analysis of your grant application.
You are referring to a trial by Seibert et al. As I mention in that letter, I have not been able to find their description where you and Dr. Wright from the National Institute for Child Health and Human Development say it was published. May I ask you to please send me a copy of that article?
look forward with interest to hearing from you, and I remain
U.S. Senator Russ Feingold
I received no further reply from Dr. Spencer or Dr. Reynolds.
Continue to evaluate in the series on "Sovereign doctors" the persistence of the non-response and cover-up all along the further path of my complaint about this fake study through the bureaucratic maze to its dead end at the medical stonewall.
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