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Executive Summary

DES ASSOCIATION WITH BREAST CANCER, CERVICAL DYPPLASIA AND CARCINOMA should be further investigated through continued follow-up of diethylstilbesterol (DES) exposed individuals and analysis of DES interaction that "compared to the situation in 1978," when it first issued a report on DES, "the weight of the evidence in January 1985 now indicates that women who used DES during their pregnancies may subsequently experience an increased risk of breast cancer." The HHS task force report was circulated by the Health Research Group the week of July 8. HRG also released with the report a letter the group sent to HHS Secty. Heckler criticizing the dept.'s failure to take action on the task force recommendations, which HRG said were submitted to HHS on Feb. 8. The consumer group is seeking a response from Heckler outlining when HHS will implement the task force recommendations. Copies of HRG's letter were also addressed to Rep. Waxman (D-Calif.), Rep. Dingell (D-Mich.), Sen. Kennedy (D-Mass.) and Sen. Metzenbaum (D-Ohio). HRG requested HHS to reconvene the 1978 DES task force last December. Although the task force found there is now greater cause for concern than there was in 1978, it stated that "a causal relationship has not been established" between DES and breast cancer. The report identified eight issues as "major reasons why the task force is unable at this time to make a more aggressive interpretation of some of the positive findings showing an association between DES and breast cancer. For instance, the report found that in the studies the task force evaluated, the overall relative risks that show excesses range from 1.2 to 1.5. "In epidemiologic analyses these levels of excess risk are difficult to evaluate, since it is hard to rule out various sources of bias that could be responsible for such excesses," the report stated. Noting that in two observational studies the risk increased with duration of follow-up, rising to approximately two-fold for those followed for 20 years or more, the report said these findings are not consistent with findings of other studies. With regard to the risk of squamous cell cancer of the cervix in daughters exposed in utero, the report noted that "a recent study indicates that there may be an increased risk of dysplasia of the cervix and vagina among the exposed, particularly among those who have extensive metaplasia." However, the report said this concern is currently based on only one study and therefore "issues related to the clinical findings, epidemiology and pathology need to be addressed in further investigations."

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