Use Of DES Research Articles

Clinical findings and legal resolution in sexual assault

Female sexual assault victims who received medical evaluation at Detroit Receiving Hospital from July to December 1980 and were seen by the Rape Counseling Center (RCC) were evaluated. Data were abstracted from the emergency department record, RCC file, and gynecology clinic; 372 patients were evaluated. One hundred twenty-seven patients (34%) were given DES, including 17 women who had been raped at least once before. Data regarding DES dosage were available only on 34 patients, with 27 stating they took the entire course; 5, an incomplete course; and 2 refusing to answer. DES is still approved for post-coital contraception in rape. However, if there is one major concern about its administration, it is that close follow-up be provided to anticipate or eliminate complications, especially those associated with inadvertent pregnancy. The extremely poor medical follow-up, the surprising lack of an "appropriate chief complaint" when follow-up does occur, the large number of sexual assault victim repeaters in an inner city population, and the socioeconomic and demographic characteristics of an urban, inner-city sexual assault victim population which make it impossible to determine the effectiveness of DES are strong arguments for the severe restriction of use of DES in the urban, inner city setting. There is no need for pretreatment GC cultures or VDRL assays. Patients should be treated in conformity with current CDC recommendations. Where a rape counseling center is available, it is suggested that the unit assume close and direct responsibility of directing patients for medical follow-up, regardless of emergency department treatment.

Regulatory History of DES

In 1941 FDA first permitted a new drug application (NDA) to become effective for DES, for use as a human drug. New animal drug applications (NADA's) became effective beginning in 1947 for use of DES as a growth promotant for poultry, cattle, and sheep in animal feed, and later in animal implants. Using the analytical methods available at that time, no residues could be found in the tissues of the animals used for human food.

Why was diethylstilbestrol banned in meat production?

Joseph V. Rodricks recently resigned his position as Associate Commissioner for Science at the FDA. His career at FDA spanned 15 years in which he was involved in developing guidelines for the conduct and evaluation of toxicity studies used for the safety evaluation of food additives and contaminants. He is currently Science Director at Clement Associates, a Washington consulting firm specializing in toxic substance hazard evaluation. In the United States, concerns about the safety of food have been embodied in laws that dictate the conditions under which new substances may be deliberately added to foods to achieve des~ired technological goals. These laws recognize that society benefits from the use of additives in food production, but they also place certain demands on manufacturers who wish to introduce such substances into commerce. Specifically, manufacturers are required to provide information about the chemical and toxicological properties of a proposed food additive sufficient to show the safety of the substance under its proposed conditions of use. If a showing of safety (which the law defines as 'reasonable certainty of no harm') cannot be made, then a proposed additive cannot legally be used in food. DES, while not directly added to food, can enter food indirectly because of its use as an animal growth promotant, and it is therefore subject to the food additive requirements of law. In its recent action to prohibit the use of DES as an animal growth promotant, the U.S. Food and Drug Administration (FDA) held that the manufacturers of DES had failed to provide the information necessary to ascertain that animal drug uses of DES are safe. Professor Jukes has thus misinterpreted the basis of FDA's action, the full details of which are set forth in the official document he cites 1.

Vaginal epithelial changes associated with in utero DES exposure.

To determine the true prevalence of vaginal epithelial changes in DES-exposed offspring, the National Cancer Institute funded the DESAD Project, a study designed to follow up these women for 4 years and to determine the prevalence of cancer and various other abnormalities in DES-exposed women. 3339 women have constituted the project study cohort as of 12/31/76. Each woman in the DESAD Project undergoes breast, pelvic and colposcopic examinations, as well as vaginal and cervical cytology. Details of her gynecologic, sexual, and reproductive history are also obtained. 34% of the record review participants had vaginal epithelial changes (this rate is much lower than previously reported); no clear cell adenocarcinoma nor severe dysplasia or carcinoma in situ of either the vagina or cervix had been found in any of the women participants. A multivariate analysis of various factors of participant history and examination findings indicate that timing of onset of exposure to DES; total dosage of DES; duration of DES exposure; and age at initial examination correlated with vaginal epitheliel changes. Vaginal epithelial changes were also found to occur less frequently after 26 years of age. Maternal history (indication for use of DES); maternal age; and exposure to other hormones did not correlate with vaginal epithelial changes. The DESAD Project is currently investigating the changes in vaginal epithelium over time, and is also examining women for any evidence of neoplasia of the lower reproductive tract.

Correction

An article in the 18 August issue of Science stated that, in his 1960 congressional testimony relating to the use of diethylstilbestrol, Thomas P. Carney, the then vice president for research at Eli Lilly, ignored the fact that human cancers may have a long latency period. This is incorrect, in that Carney's testimony cited a history of the use of DES extending over more than 20 years. The same article stated that the chairman of the Food Protection Committee of the National Academy of Sciences is William J. Darby. Dr. Darby resigned as chairman in July 1971. The present chairman is Lloyd J. Filer of the University of Iowa College of Medicine. These errors are regretted.