Federal Advisory Panel Seeks No Change in Warning Labels for Birth Control Pills
A federal advisory panel, confronted by conflicting evidence on the relationship between birth control pills and breast cancer, decided Thursday against recommending new warning labels for oral contraceptives.
Although some members argued that labeling should be revised to reflect concerns raised by new studies, they agreed that the findings were inconclusive and that, overall, there was no proven association between oral contraceptives and breast cancer.
The panel, which called for further research, agreed also that there was no need for changes in prescribing practices by physicians.
Current labeling of oral contraceptives for physicians and patients states that the evidence shows little or no association with breast cancer.
The panel’s action on a 7-3 vote came after a daylong discussion of surprising new findings that the use of oral contraceptives may increase the risk of breast cancer. Many previous studies had shown no such association. Moreover, the authors of the new studies acknowledged that they were perplexed by their own data.
“We simply do not know whether the pill is associated with any increased risk of breast cancer,” said Dr. Clifford R. Kay of the Royal College of General Practitioners research unit in Manchester, England, one of several researchers who presented his findings to the committee.
One FDA official emphasized that the studies were based on women who took pills containing “substantially higher” doses of hormones, particularly estrogen, than are found in most oral contraceptives now on the market. The newer pills are believed to be much safer.
The Fertility and Maternal Health Drugs Advisory Committee that made the recommendation is a panel of medical experts that meets periodically to advise the commissioner of the Food and Drug Administration on policy matters regarding reproductive biology. Although the commissioner is not bound by an advisory panel’s decision, such recommendations usually play a major role in influencing agency decision-making.
Pill Introduced in 1960
About 13.2 million American women take oral contraceptives, which were introduced in the United States in 1960.
Breast cancer will strike one in 10 American women, the American Cancer Society says. The organization has estimated that there were 135,000 new cases in 1988, and 42,300 deaths.
Kay and his colleagues studied 46,000 women, half of whom took the pill. His work found that pill users were more than three times as likely to develop breast cancer between the ages of 30 and 34 as women who did not take the pill. Breast cancer is relatively rare in younger women and typically afflicts women over age 50.
Kay said that “knowing the epidemiology of breast cancer,” which he said can take up to 30 years to develop after exposure to a cancer-causing substance, he thought it unlikely that birth control pills were the primary agent responsible for the disease. But, he said, they might contribute to “an accelerating process” that had already begun.
Further Observation Urged
He said he believed that it was “absolutely crucial to go on observing this (group) as it grows older” to determine if the risk of breast cancer continued to increase. If it did, he said, it would be “a devastating condemnation of the pill.”
A second study, scheduled for publication next month and conducted by researchers at Boston University School of Medicine, the University of Pennsylvania and Memorial Sloan-Kettering Cancer Center in New York, determined that the longer women took the pill, the greater their chances were of developing breast cancer.
The study found that, contrasted with women who had never used oral contraceptives, the risk of developing breast cancer by age 45 was twice as high for women who had used birth control pills for fewer than 10 years and four times as high for those who had used the pill longer than 10 years.
In addition, a re-evaluation of previous studies showed an increased risk of breast cancer in certain groups of women and under certain conditions. For example, a Food and Drug Administration review of a study by the Centers for Disease Control--which had previously reported no association between the pill and breast cancer--found that women who never had children and who began menstruating before age 13 had an increased risk, depending on how long they had taken the pill.
Dr. Sidney Wolfe, director of the Public Citizen Health Research Group, a consumer organization, told members of the committee that current labeling was “hopelessly out of date” and needed to reflect the latest data. “Although this conflicting evidence is not clear enough to say that the pill causes breast cancer, there is cause for concern,” he said.
The current labeling gives “millions of American women . . . a false sense of security,” he said.