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December 28, 1994

The Italian Pertussis Vaccine Trial: Ethical Issues

JAMA. 1994;272(24):1898-1899. doi:10.1001/jama.1994.03520240026027

To the Editor.  —We would like to comment on the Medical News & Perspectives report in The Journal1 on the need for a national ethics advisory board in the United States. It is unclear to us why the clinical trial of pertussis vaccines in Italy (Progetto Pertosse) is automatically assumed to have inadequately protected the rights of human subjects. The report of the meeting of the Congressional Biomedical Research Caucus infers that conclusions of impropriety have been reached or there is wide dissenting opinion in Italy on the conduct of this project. As such, the scientific readership of JAMA has not had the opportunity to consider other views on the project from researchers of the Istituto Superiore di Sanitá (ISS) (the technical and scientific body of the Italian Health System) who conducted the project or members of ethics, pharmacoepidemiologic, or pediatric groups in Italy.While there is no doubt