Conflict of Interest and Purpose in Bilirubin Screening: In Reply

Abstract

In Reply.—I thank Dr Lavin for his comments. Perhaps my conclusion was a trifle hyperbolic, but I have no hesitation in standing by the statement that the ability to measure a transcutaneous bilirubin (TcB) level in the office should be very valuable for the practicing physician. When Dr Lavin sees a jaundiced newborn on day 3 or 4 in his office and decides to get a bilirubin level, would he prefer a completely noninvasive, instantaneous measurement of the bilirubin or would he rather perform a heel stick on the infant (or have it done elsewhere) and wait several hours for the results? More important, what does he think the mother (and the infant) would prefer?In our study, data from 40 infants were obtained from a private-practice group, and discussions with these physicians amply confirms that they have found this instrument to be very useful. We have been using TcB measurements in our own outpatient clinic for >6 months, and I can assure Dr Lavin that our residents and attending physicians find it equally useful.In addition to providing instantaneous and important information about the infant's bilirubin level, the use of TcB measurements in both the nursery and the office have another clear benefit: they drastically reduce the number of serum bilirubin measurements obtained. Before using the JM103, we used the JM102 as a screening device, and we have shown that it significantly reduces the need for heel-stick testing for bilirubin levels.1 The introduction of the JM103 has led to a further 78% reduction in the number of serum bilirubin tests performed in our nursery. I hope Dr Lavin will agree that this has some value.We also noted that use of TcB measurements could avoid some of the errors associated with the clinical estimation of bilirubin levels, a fact that has been confirmed in a clinical study.2 The recent clinical practice guideline on the management of hyperbilirubinemia in the newborn infant3 notes that “visual estimation of the degree of jaundice can lead to errors, particularly in darkly pigmented infants.” Those of us who have had the opportunity to review the records of infants with kernicterus know that such errors have occurred.TcB measurements are not a panacea, but they can help to answer the questions “should I worry about this infant?” and “should I obtain a serum bilirubin level on this infant?”4 I find the answers to these questions to be very helpful in my management of the jaundiced newborn.I agree with Dr Lavin's view that just because the device gives “a reliable result,” it “does not establish that a screening program would be a net good”; however, this issue was never addressed in our article, and I am not sure why he raises it here. Kernicterus is a devastating condition, and it is still occurring,3,5 but I agree that we do not have any data to show that widespread determination of bilirubin levels in healthy infants will actually reduce the incidence of kernicterus. Again, neither our article nor the new guideline3 makes any such claim. The new guidelines, however, do note that measurement of a serum bilirubin level or TcB level before discharge from the nursery is the “best documented method for assessing the risk of subsequent hyperbilirubinemia,”3(p301) a fact that has been documented in 6 separate studies.6–11Dr Lavin mentions screening for neuroblastoma in infancy as an example of a test that might do more harm than good. This may be true, but unlike neuroblastoma in infancy, hyperbilirubinemia is by no means rare. By itself it is not a disease, but if the bilirubin level gets very high, it can certainly cause profound damage to an otherwise healthy infant.Dr Lavin asserts that if we measure more bilirubin levels, it will result in more action to reduce bilirubin levels. TcB measurements have been widely used in Japan and less widely used in the United States for well over 20 years. We have no evidence that such testing has resulted in any increase in intervention. The new guidelines contain recommendations for intervention using phototherapy and exchange transfusion, which differs little from those recommended in the 1994 guidelines.3,12I don't find it ironic that an article documenting a beneficial role for bilirubin appeared in the same issue of Pediatrics. The fact that bilirubin might have a physiologic function was first noted in 193713 and has been amply confirmed since then. In adults there is evidence that decreased bilirubin levels are associated with an increased risk of coronary artery disease and peripheral vascular disease,14 but I have yet to identify a newborn who suffered a bad outcome because he/she had too little bilirubin in the serum.Finally, Dr Lavin notes that, because this study was partly supported by Minolta and Hill-Rom Air Shields, there is an inherent conflict of interest that might call into question the validity of this study. The only way to refute this insinuation is to have the study design and the data speak for themselves. Because all TcB measurements were obtained independently by individuals who had no knowledge of the serum bilirubin measurements, there should be no bias in the recording of the data. Although Minolta and Hill-Rom Air Shields provided support for the study, none of the authors have any financial interest in these companies, nor do any of them stand to benefit in any way from the results of this publication. Neither these data nor the manuscript were submitted to the company's representatives before publication. I resent the implication that we are promoting a device. We reported data that suggest that TcB measurements can be substituted for serum bilirubin measurements in many circumstances. If these observations are confirmed in other settings, I stand by my opinion that TcB measurements will be of inestimable value to the pediatrician, the infant, and the family.