The Walnut Creek Contraceptive Drug Study is, nonetheless, startling. Begun in 1968, it included 16,638 women between 18 and 54, all of them enrolled in a health plan using Kaiser-Permanente. That made it the largest study of its kind ever done. Its conclusion: "The risks of oral contraceptive use appear to be negligible."
Ramcharan, who took over the project in 1971, says Pill users apparently do not run higher risks of breast, uterine or ovarian cancers. In several cases where increased incidences of a malady did appear, the report cites other causes. For instance, Ramcharan attributes the increase in cervical cancer found among Pill users to their more active sex lives (early intercourse and an unusually high number of partners). Similarly, a perceived increase in skin cancer among Pill users may be explained by the fact that these women frequently are heavy sunbathers. Slightly higher than average heart disease rates can be traced, at least partly, the study says, to the fact that more Pill users smoke than nonusers. Ramcharan did find a minor but consistent increase in blood pressure among users. "The women were not hypertensive," she says, "but on the borderline of normal."
Further research is needed, Ramcharan admits, because the Walnut Creek women were almost all white and middle class, the primary users of The Pill when the study began. They would also be healthier than the population in general, since they were enrolled in a health maintenance program.
Not surprisingly, the report and Ramcharan have already come in for criticism. Medical author Barbara Seaman, whose 1969 book The Doctors' Case against The Pill has been revised and reissued, attacks the Walnut Creek study as "grotesquely flawed," questioning its statistical methods. She also accuses Ramcharan of using grants from pharmaceutical firms that make The Pill to finance completion of the study after the National Institutes of Health (NIH) grants were exhausted last March.
Ramcharan denies that the study has received any private grants since March, explaining that only one $150,000 project (in 1975-76) was funded by drug companies.
"We are going to have to look to private enterprise for funding in the future," Ramcharan believes, fearing a period of decreasing federal research funds. "The argument opposing is that companies will tell us what to say. Absolutely not. I know who I am, and nobody influences my work."
A spokesman for the Center for Population Research at the NIH, which supplied $8.5 million to the Walnut Creek study, says that while more data are needed—"We wouldn't call Walnut Creek definitive"—the center does not question Ramcharan's results, methodology or motivations.
Ramcharan, an Indian shopkeeper's daughter born in Trinidad, received a government scholarship to study in Canada and justified the award by graduating first in her class at the University of Toronto Medical School. She has since done research at Harvard, Stanford and Berkeley, earning both a master's in public health and her Ph.D. in epidemiology. Her work in India and this country included a 1957-59 assistantship with Dr. Gregory Pincus, co-developer of the first commercial oral contraceptive, Enovid.
A widow (her husband, also a doctor, died in 1972) and mother of a 24-year-old son, Andrew, Ramcharan says she has never taken The Pill herself. It came on the market too late for her prime childbearing years, she says. As for other women, she advises: "Don't make panicky decisions. If you're scared of The Pill then you shouldn't take it. That defeats its purpose, which is to regulate fertility so you can better the quality of life."
Heavy smokers or women who have a history of cardiovascular disease should not take The Pill, she says. "It is an individual decision each should make with the help of a health adviser. The last word is not in."
Few drugs in medical history have evoked such controversy as the oral contraceptive for women. So Dr. Savitri Ramcharan, 57, an epidemiologist at Kaiser-Permanente Medical Center in Walnut Creek, Calif., begins any discussion of her new report on The Pill—which is still used by 10 million U.S. women—on a cautionary note. "If this study is used to make the position that The Pill is absolutely safe," she says, "that would be overreaction—just as The Pill scare was."