The story of the birth-control pill is a lesson in having to take the bitter with the better. The up side is well known: not only does the pill prevent unwanted pregnancies, but one of the two active ingredients, progestin, helps ward off cancer of the uterus and ovaries. In recent years, however, research has seemed to indicate that the other main component in the pill, estrogen, may actually cause cancer of the breast. Although such findings have been disputed, and the amount of estrogen in most birth-control pills has been decreased substantially in recent years, the need for an alternative pill appears obvious. Now a 43-year-old Dutch doctor has stepped forward with a formula that, he says, has all the contraceptive properties of the ordinary pill, plus prevents breast cancer.
In his new pill, the B-Oval, Dr. Michael Cohen has made a simple switch. The progestin remains. But in place of estrogen, Cohen has substituted melatonin–a hormone, secreted from the brain’s pineal gland, which plays a role in regulating female reproductive cycles. Melatonin, unlike estrogen, inhibits the monthly process in which the body rallies cells to the breast for purposes of lactation. When a women does not conceive, the cycle continues and those cells generally disperse. Some cell clumps, however, often remain. It is Dr. Cohen’s theory that this residue–which is prevented by the use of melatonin–can cause cancer of the breast. If he is correct, taking the B-Oval pill would, in most cases, be preferable to taking no oral contraceptive.
So far Cohen has demonstrated melatonin’s salutary effect on breast cancer only in rats. He’s tested B-Oval on approximately 1,000 Dutch women over the course of four years. To date, none of the 600 women now in the final phase has shown any side effects. Cohen has not published his findings; he was waiting for a patent, which he has now secured. One who has seen his data is Dr. Alan H. DeCherney, a professor of obstetrics and gynecology at Yale University. While stressing that “melatonin’s impact on preventing breast cancer is purely hypothetical,” he calls B-Oval “an important compound that adds significantly to contraceptive technology and approach.”
The entire medical community is not aboard the B-Oval bandwagon. “It’s too early to know whether [it] is going to work well and over a prolonged duration,” says Dr. Andy Anderson, director of clinical research for Contraception Research and Development, a government program in Virginia. In the meantime, women are faced with limited choices in the area of oral contraceptives: either the standard pill or the “mini-pill,” a progestin-only product that can cause side effects such as cramps and irregular menstrual bleeding. A new product called Norplant, which secretes progestin from a device implanted in the arm, is now coming on the market. Female condoms and hormone-secreting vaginal rings may be available by the mid-’90s. A reversible antifertility vaccine for men and women is also under development.
The B-Oval pill, meanwhile, could be available in the Netherlands as early as this fall. In America, the product is probably at least several years away from FDA approval. The National Institutes of Health in Washington recently turned down Cohen’s request for a $32 million grant so he could begin testing in the United States, saying that his claims are too speculative and “scientifically untenable.” That doesn’t mean the B-Oval is a dead issue, just that, despite its apparent potential for preventing breast cancer, the new pill has been shuffled, at least temporarily, to the rear of the medicine chest.
