Reporting Provocative Results: Title and subTitle BreakCan We Publish 'Hot' Papers Without Getting Burned? FREE

James L. Mills, MD, MS

[+] Author Affiliations

Reprint requests to Epidemiology Branch, National Institute of Child Health and Human Development, Landow Bldg, Room 8B06, Bethesda, MD 20892 (Dr Mills).

JAMA. 1987;258(23):3428-3429. doi:10.1001/jama.1987.03400230088038

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References

ABSTRACT

ABSTRACT | REFERENCES

IN APRIL 1981, JAMA published an article reporting an association between spermicide use around conception and congenital disorders.¹ The authors were careful to note that "the results should be considered tentative until confirmed by other data." Nevertheless, their findings were taken up by the media and lawyers and treated as if they were established facts. Pregnant women who had used spermicides around conception became alarmed, and spermicide manufacturers were sued by former users who had had malformed infants.

Some journals publish exciting positive findings but are loathe to publish subsequent negative investigations that contradict them. JAMA, to its credit, published an editorial the following year explaining why the association should be considered tentative or preliminary,² along with several studies^3,4 that did not find any association between spermicides and birth defects. Subsequently, a number of negative studies appeared in other journals,⁵ and Food and Drug Administration hearings

REFERENCES

ABSTRACT | REFERENCES

Jick H, Walker AM, Rothman KJ, et al: Vaginal spermicides and congenital disorders . JAMA 1981;;245:1329-1332.

Oakley GP: Spermicides and birth defects . JAMA 1982;;247:2405.

Shapiro S, Slone D, Heinonen O, et al: Birth defects and vaginal spermicides . JAMA 1982;;247:2381-2384.

Mills JL, Harley EE, Reed GF, et al: Are spermicides teratogenic? JAMA 1982;;248:2148-2151.

Bracken MB: Spermicidal contraceptives and poor reproductive outcomes: The epidemiologic evidence against an association . Am J Obstet Gynecol 1985;;151:552-556.

National Center for Drug and Biologics: Minutes of the Fertility and Maternal Health Drugs Advisory Committee Meeting . Bethesda, Md, Food and Drug Administration, 1983;.

Wells v Ortho Pharmaceutical Corp, 788 F2d 741 (11 Cir 1986).

Data do not support association between spermicides, birth defects . FDA Drug Bull 1986;;16:21.

Holmes L: Vaginal spermicides and congenital disorders: The validity of a study . JAMA 1986;;256:3095.

Watson JD, Crick FHC: Molecular structure of nucleic acids: A structure of deoxyribose nucleic acid . Nature 1953;;171:737-738.

Chen JR, Francisco RB, Miller TE: Legionnaires' disease: Nickel levels . Science 1977;;196:906-908.

Sunderman FW: Perspectives on Legionnaires' disease in relation to acute nickel carbonyl poisoning . Ann Clin Lab Sci 1977;;7:187-200.

Smith OW, Smith G van S: The influence of diethylstilbestrol on progress and outcome of pregnancy as based on a comparison of treated with untreated primagravidas . Am J Obstet Gynecol 1949;;58:994-1009.

Brackbill Y, Berendes HW: Dangers of diethylstilbestrol: Review of a 1953 paper . Lancet 1978;;2:520.

Rosenberg SA, Lotze MT, Muul LM, et al: Observations on the systemic administration of autologous lymphokine-activated killer cells and recombinant interleukin-2 to patients with metastatic cancer . N Engl J Med 1985;;313: 1485-1492.

Jones KL, Smith DW, Ulleland CN, et al: Patterns of malformations in offspring of chronic alcoholic mothers . Lancet 1973;;1:1267-1271.

Lemoine P, Harousseau H, Borteyru JP, et al: Les enfants de parents alcooliques: Anomalies observees a propos de 127 cas . Ouest Med 1968;;21: 476-482.

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Country-Specific Mortality and Growth Failure in Infancy and Yound Children and Association With Material Stature

Use interactive graphics and maps to view and sort country-specific infant and early dhildhood mortality and growth failure data and their association with maternal