Bendectin and birth defects: hopefully, the final chapter.

The study published in this issue of Birth Defects Research Part A, “Bendectin and Birth Defects: Ecological Analysis,” by Kutcher et al. (2002) deals with two aspects pertaining to the effects of Bendectin. It is an excellent research article. The first area investigated was related to the question as to whether Bendectin was a human teratogen based on ecological analysis. The second area investigated was whether admissions to the hospital for intractable nausea and vomiting of pregnancy increased after the withdrawal of Bendectin from the market. The evaluation of the merits of the allegation as to whether Bendectin represents any reproductive risks has been reported in review articles in the teratology and legal literature (Brent, 1995a, 1997) utilizing a methodology that has been described previously (Brent, 1978, 1985c, 1986). This evaluative process has been utilized on several occasions for other drugs, chemicals and physical agents (Brent et al., 1991, 1992, 1993, 1995a, 1997, 1999a; Brent et al., 1991, 1993; Christian and Brent, 2001). The method of evaluation is listed in Table 1 and consists of five components of the evaluation process, which include 1) consistency of epidemiological studies, 2) secular trend analysis, 3) animal studies, 4) toxicokinetics and pharmacokinetics, and 5) basic science principles. Kutcher et al. (2002) focused on two aspects of the Bendectin saga in their article: 1) ecological analysis, and 2) the impact of the withdrawal of Bendectin from the market on the treatment of nausea and vomiting and the clinical effects of the withdrawal of Bendectin from the market place.