Embryo Project Encyclopedia

The United States Food and Drug Administration, or FDA, published 'General Considerations for the Clinical Evaluation of Drugs,' in September 1977. The document defined acceptable practices for investigators who studied new drugs. Specifically, the document outlined the common clinical trial methods. Clinical trials are studies to test whether a new drug is safe before doctors can prescribe it to patients. Prior to 1977, the Protection of Human Subjects Rule primarily regulated clinical drug trials, but it did not specify who could and could not be included in clinical trials. In the document, the FDA recommended that anyone who could become pregnant be excluded from early-phase clinical trials to minimize risks to a potential fetus. After the FDA published the document, investigators excluded women from clinical trials. The document ultimately prevented women of reproductive capacity from participating in early phase clinical trials, which affected women’s health research.

From 1963 to 1982, researchers in New York City, New York, carried out a randomized trial of mammography screening. Mammography is the use of X-ray technology to find breast cancer at early stages. The private insurance company Health Insurance Plan of Greater New York, or HIP, collaborated with researchers Sam Shapiro, Philip Strax, and Louis Venet on the trial. The researchers’ goal was to determine whether mammography screening reduced breast cancer mortality in women. The study included sixty thousand women aged forty to sixty-four. Half of the women received two annual breast examinations that involved mammography, a breast exam, and an interview. The rest of the women were not invited for annual examinations. After follow up, the researchers found that of the women who received the examinations, thirty percent fewer died from breast cancer than the women who did not receive any examinations. The HIP trial was one of the first large-scale clinical trials to provide evidence that mammography screenings helped prevent breast cancer deaths in women.

Screening for Breast Cancer with Mammography is a Cochrane systematic review originally published by Peter Gøtzsche and Karsten Jørgensen in 2001 and updated multiple times by 2013. In the 2013 article, the authors discuss the reliability of the results from different clinical trials involving mammography and provide their conclusions about whether mammography screening is useful in preventing deaths from breast cancer. Mammography is an X-ray technique used to detect abnormalities in breast tissue, such as breast cancer, which affects about twelve percent of women in the world and has a significant risk of mortality. The authors concluded that mammography screenings reduced breast cancer mortality, but resulted in problems such as overdiagnosis and overtreatment of screened women. The article Screening for Breast Cancer with Mammography contributed to the then ongoing controversy about the usefulness of mammography and provided accessible information about mammograms in seven languages.