Decades of government research on breast cancer have done nothing to improve women's odds of surviving or avoiding the disease.
Although hundreds of millions of dollars have been spent on research since the National Cancer Act declared war against malignancies in 1971, the breast-cancer death rate has increased slightly and prevalence has steadily climbed.
A Newsday examination of federal research spending shows a number of factors converged to stymie progress against the disease. Women's health research was a low priority and women were routinely excluded from general health studies. Cancer research focused on treatment rather than prevention, a successful strategy against some malignancies, such as childhood leukemia and Hodgkins' lymphoma, but not effective against breast cancer. Promising breast-cancer studies were delayed or abandoned because of those policies.
"Women's health has just not been a top priority in this country -- and because of that, the battle against breast cancer suffered," says Dr. Bernadine Healy, the director of the National Institutes of Health from 1991 until she stepped down in June.
The government defends its strategy as the best option, given available information at the time, and says that policies excluding women have been eliminated in recent years. Officials at the National Institutes of Health, the clearinghouse that awards the bulk of U.S. medical-research grants, says money for breast-cancer research has increased consistently and more was spent on breast cancer through the 1980s than on any other kind of tumor.
But the record shows that no major studies on preventing breast cancer were approved until the 1980s. And during that decade, the first major prevention trial was abandoned uncompleted, partly because officials questioned whether women could be trusted to comply with diet guidelines. Another diet-based prevention trial, proposed in 1983, is only now getting under way 10 years later.
While some officials say those setbacks were isolated incidents, others believe the delays and reversals were the inevitable result of the scientific mind-set of the time. "I think it's a fair statement to say that before 1980 they were not particularly interested in breast cancer. They were not ignoring breast cancer, but as far as I know, they were not giving it special attention either," said John Bailar, a McGill University researcher and a former National Cancer Institute official. "This was not necessarily a bad thing, though. There just weren't a whole lot of solid clues about breast cancer to follow up."
Reconstructing the federal research effort on breast cancer is complicated. Much of the NCI budget goes to basic research applicable to a number of malignancies. So it's hard to establish how big a piece of the $2 billion annual budget really goes to breast-cancer research. But officials estimate that during the late 1980s, the agency spent an average of $67 million a year in research applicable to breast cancer, a figure that increased in the 1990s.
The Clinton administration has pledged to increase research efforts. "Breast cancer has had less attention until recently," said Health and Human Services Secretary Donna Shalala, the Cabinet member who oversees NIH.
A Newsday review of hundreds of pages of federal grant lists and research studies, and interviews with dozens of scientists and NIH decision-makers, give an insight into the factors that combined to limit breast cancer research:
* For decades, the National Institutes of Health considered male subjects the norm for study and excluded women from participating. The attitude was so pervasive that researchers didn't even include females in some studies directly related to women's health. "The gaps in our knowledge were so wide and so deep that people are suddenly saying, 'Oh my God,' " Dr. Healy said.
In the early 1980s, researchers at Rockefeller University used only men in a study of the effects of diet on estrogen, which is linked to breast cancer. A 1990 General Accounting Office report called for change.
* NIH officials favored research on treatment over prevention. Most of the emphasis -- and advances -- revolved around surgery and chemotherapy until the 1980s. While the approach worked against tumors whose cells were particularly sensitive to drugs, the tactic did not work as well for breast cancer. "There's enthusiasm and interest in finding a magic bullet, a cure for cancer . . . they really discourage other kinds of research," said Jessie Gruman, executive director of the nonprofit Center for the Advancement of Health in Washington.
* Some promising breast cancer prevention studies had difficulty getting funds, including studies of possible links between the disease and pesticides that later proved groundbreaking. Expensive trials to test the link between diet and breast cancer were considered a gamble -- and so were abandoned or stalled. One well-regarded scientist waited 10 years for funds. The process "made my hair turn gray," says Ernst Wynder, a researcher who heads the American Health Foundation in New York.
Cancer research was not a particular national priority until 1971, when President Nixon launched the National Cancer Act. Its language calling for a cure has shaped research ever since. Scientists were trying to treat and defeat malignancies after they appeared. That approach translated into less debilitating breast-cancer surgery and more effective combinations of chemotherapy drugs. Current surgical options include modified radical mastectomy, in which the breast and some underarm nodes are removed, and lumpectomy, in which only the part of the breast containing the cancer is removed.
Survival rates have improved for some subgroups of breast-cancer patients, but overall the death rate from the disease has increased slightly since the early 1970s, up from 26.9 per 100,000 women to 27.5 per 100,000 by the end of the 1980s, according to the federal figures.
The breast-cancer incidence rate rose consistently by about 1 percent a year for decades until the 1980s. Then incidence jumped about 4 percent a year, perhaps because of increased early detection efforts.
The fate of the first major breast-cancer prevention trial illustrates the major problems. That project, the Women's Health Trial, was supposed to answer a question that conflicting study results still haven't resolved: How does fat intake affect breast-cancer risk? The trial was approved in 1983 but canceled five years later partly because of doubts about women's reliability and partly because the prevention trial was an expensive undertaking in a little-explored field.