Abstract

NON-REPLICATION OF THE REPLICABLE

*Lajos Lakatos and György Balla MD

ABSTRACT

"Everything changes and nothing remains still…. and…. you cannot step twice into the same stream" Heraclitus of Ephesus (530-470 BC) We have to do this after all! In 1999, we published a provocative letter[1] to persuade others to perform multicentre prospective randomized controlled clinical trials with the title: „ Will D-Penicillamine (D-PA) administration reduce the incidence of retinopathy of prematurity (ROP).” William A. Silverman has written the above quoted title in one of his famed essays “Fumes from the spleen” signed by “Malcontent”.[2] He was the father of neonatal intensive care, and the author of a number of famed books. Bill proved to be our greatest supporter and he reviewed our reseach work in details and insisted on the importance of replications. We can say that until Silverman’s “declaration” only sporodical publications appeared in Hungarian and Polish journals mainly about the treatment of neonatal jaundice. This fact was especially distressing for us because in the 1970s and 1980s years D-PA therapy was widely used in Hungarian hospitals for preventing exchange transfusions in the treatment of neonatal hyperbilirubinaemia. Then, we published the letter mentioned[1] which and a personal meeting in Utah resulted in publications of Christensen and his coworkers.[3,4] They also recognised no immediate intolerance of the prepared solution of D-PA given by nasogastric tube, nor did they observe any evidence of renal, haematological, or hepatic toxicity in those 5 patients approved by the FDA. Their analysis is a comparison of outcomes of 15 patients who were treated with D-PA, with 34 preterm infants of similar gestational age and birth weight who were cared for in the same NICU after the conclusion of the first (feasibility) study but before the start of the second (pharmacokinetics) study. The 34 non- treated and the 15 DPA treated patients were of similar gestational age, birth weight, and gender distribution.

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