Testimony Before the FDA

Text of Oral Testimony given before the Reproductive Health Drugs Advisory Committee of the Food and Drug Administration at its Public Meeting of July 19, 1996

by Joel Brind, Ph.D., 
Professor of Endocrinology, Department of Natural Sciences, Baruch College of the City University of New York, New York, NY 10010

In the 3-1/2 years since I sent Commissioner Kessler a detailed letter summarizing the research literature on abortion and breast cancer, considerable additional data have been gathered, bringing the issue into much sharper focus. To date, a total of 30 published reports describe 24 separate epidemiological studies which give specific data on induced abortion and breast cancer incidence. 19 of the 24 report overall increased breast cancer risk, 12 with statistical significance. Several important conclusions can be clearly drawn based on this substantial body of worldwide knowledge dating back to 1957:

1) Only induced abortion—not spontaneous abortion-is consistently linked to the incidence of breast cancer. The biological basis of this difference is also clear: Most spontaneous abortions are characterized by subnormal ovarian estradiol secretion. It is the surge of estradiol early in a normal pregnancy which provides an estrogen overexposure by which most known risk factors increase breast cancer risk.

2) Induced abortion increases breast cancer risk independently of its effect in delaying first full term pregnancy. An early full-term pregnancy decreases breast cancer risk. Since induced abortion also abrogates this protective effect, it raises breast cancer risk in two ways for young nulliparous women.

3) The increased breast cancer risk attributable to induced abortion cannot be explained by response bias in case-control studies. The only study claiming to provide direct evidence of response bias relies on the specious conclusion that breast cancer patients report having had abortions that never took place, and the only other study using prospective data found a statistically significant 90% risk increase.

4) There is now evidence of a particularly strong interaction between induced abortion and family history of breast cancer, shown by two studies published in 1994.

5) There is no basis for assuming that the somewhat younger average gestational age of medically induced abortions will confer any less of a breast cancer risk increase than surgical abortion: Neither of the two studies which looked at the timing of first trimester induced abortions found a significant difference between abortions before versus after 9 weeks. Endocrinological evidence backs this up: Estradiol begins to surge measurably within a few days after conception. Unfortunately, the short time allotted today does not permit me to report specific data. However, along with colleagues at the Penn State Hershey Medical Center, I have completed a “Comprehensive review and meta-analysis” on the subject, which is now in press for this October’s Journal of Epidemiology and Community Health. Although subject to embargo, I can provide the FDA a copy if you are interested.

In the drug approval process to date for mifepristone/misoprostol, has breast cancer, even as a potential risk factor, ever come up? Indeed, the overall, highly significant positive association between induced abortion and breast cancer, which we have documented in the meta-analysis, demands that women be warned at the very least. Such warnings are already mandated to be given to any women considering induced abortion by law in Louisiana Montana and Mississippi, with more such laws in the pipeline.

Finally, we are not speaking here about any concern for the life of any fetuses: only about the life and health of the women who may be able to take these abortifacient drugs. However safe this drug regimen may appear in short term testing, there is too much hard evidence that in the long term, many thousands of women will get breast cancer because they took these drugs. If this agency can simply approve, as the Population Council has requested, the legitimate use of such drugs by healthy women in order to achieve elective medical results, then we will have witnessed, in effect, the end of the Food and Drug Administration as we know it, for this agency will have abandoned its function to protect American women from purveyors of harmful medicine.