Copyright 2001 American Medical Association. All Rights Reserved.
Applicable FARS/DFARS Restrictions Apply to Government Use.2001
In Reply: These correspondents share 2 concerns.
The first is disagreement with our selection criteria for articles1—that the criteria were excessively stringent
in restriction to human samples, peer review, masked assessment, and prospective
recruitment, and simultaneously inadequately selective with respect to attrition
and sample size. Animal studies are, as the thalidomide tragedy showed, unreliable
indicators of a teratogenicity of a substance or its safety in humans. Methodologic
issues also influence interpretation of animal data—whether cocaine
effects are found varies by species, sex, timing of exposure, mode of administration,
age at assessment, and whether control animals were pair fed with exposed
animals.2 Except for the article by Leech
et al,3 which was presented in detail in
our review, the other articles with human subjects cited by Drs Stanwood and
Levitt were in a non-peer–reviewed publication.4
Without the exposition of the methods demanded by a peer-reviewed journal,
these works-in-progress cannot be interpreted with confidence. We make no
apologies for excluding, in spite of large sample sizes, articles that lack
prospective recruitment or masked assessment; these criteria were justified
in detail in our review.1
Frank DA, Augustyn M, Grant Knight W, Pell T, Zuckerman B. Prenatal Cocaine Exposure as a Risk Factor for Later Developmental Outcomes—Reply. JAMA. 2001;286(1):45–47. doi:10.1001/jama.286.1.45
Customize your JAMA Network experience by selecting one or more topics from the list below.