PEDIATRICS Vol. 114 No. 4 October 2004, pp. 1133 (doi:10.1542/peds.2004-1408)
Conflict of Interest and Purpose in Bilirubin Screening
Arthur Lavin, MDAdvanced Pediatrics
Beachwood, OH 44122
To the Editor.—
In the June issue of Pediatrics, Maisels et al1 report on the characteristics of measure of a brand of transcutaneous bilirubinometer. It would have been best if the authors had limited their conclusions to how the meter performed.
However, the authors conclude their report with the statement: "The ability to measure the TcB [transcutaneous bilirubin level] in the office or other outpatient setting ... should prove of inestimable value."1(p1635) This statement was not tested in the evaluations conducted in the study, and no references are cited to prove that this statement is true.
The ability of a device to give a reliable result does not establish that a screening program would be a net good. The experience of screening for neuroblastoma in infancy in Japan demonstrates that a rare and serious disease might interest a community in screening for it, and yet once screening is undertaken, more harm than good occur.
Does our good intention to prevent kernicterus serve as sufficient basis to prove that widespread determination of bilirubin levels in healthy infants will actually reduce the incidence of kernicterus?
Additionally, the study has an inherent conflict of interest: Minolta and Hill-Rom Air Shields helped pay for the study. Not only was evaluation of the performance of the device paid for by its manufacturers, but a gratuitous, unsubstantiated endorsement for the widespread use of such a device helps conclude the article.
How ironic it is that compelling evidence for a beneficial role for bilirubin is in the same issue.2 This article may explain why the body expends energy in the creation of a water-insoluble waste product that requires conjugation to excrete (bilirubin) instead of stopping at the creation of the easily excreted first product of hemoglobin metabolism (biliverdin).
Before we mount a campaign to measure millions more bilirubin levels, an action that will result in millions more actions to reduce bilirubin levels, shouldn't we consider what harm may be done in taking away potentially beneficial bilirubin levels in millions of cases? Shouldn't we also know if proposed screening and treatment algorithms would prevent the rare case of kernicterus, which may reflect problems with the blood-brain barrier or distribution of free and bound bilirubin more than simply the level of total serum bilirubin?
Let's leave the promotion of devices to industry and preserve the realm of scientific inquiry and testing for medicine.
REFERENCES
- Maisels MJ, Ostrea EM Jr, Touch S, et al. Evaluation of a new transcutaneous bilirubinometer.
Pediatrics. 2004;113
:1628
–1635
[Abstract/Free Full Text] - Sedlak TW, Snyder SH. Bilirubin benefits: cellular protection by a biliverdin reductase antioxidant cycle.
Pediatrics. 2004;113
:1776
–1782
[Free Full Text]
PEDIATRICS (ISSN 1098-4275). ©2004 by the American Academy of Pediatrics
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Related articles in Pediatrics:
- Conflict of Interest and Purpose in Bilirubin Screening: In Reply
- M. Jeffrey Maisels
Pediatrics 2004 114: 1133-1134.[Extract] [Full Text]
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