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Deaths Attributed to Birth-Control Patch Increase 8/1/2005 Are “reproductive rights” replacing sound medicine?
“On your body, off your mind”—this clever catch phrase is associated with the birth-control patch, Ortho Evra, which has advertisements spotlighting supermodel Naomi Campbell and the Norwegian Olympic beach volleyball team.
Despite appealing advertising, though, Ortho Evra—which went on the market in 2002—is causing serious concerns. It is being pinpointed as the cause of death of 23 women, including 17 in the past two years due to blood clots. Blood clots are seen as a high risk for hormonal birth control because estrogen promotes blood coagulation.
The other deaths resulted from heart attacks and strokes.
The patch’s manufacturer, Ortho-McNeil, said that the deaths and side effects caused by the patch are consistent with the health risks of the pill. However, the Associated Press (AP) analyzed 16,000 reports of adverse events filed with the Food and Drug Administration and found that the risk of death from a blood clot is three times higher for women using the patch. Since 2004, more than 800,000 women have used it.
According to the AP article, women under 35 who don’t smoke and use the pill have a 1 to 3 in 10,000 chance of having a nonfatal blood clot and a 1 in 200,000 risk of dying from a blood clot. If these same women use the patch, the rate of nonfatal blood clots was about 12 out of 10,000 during clinical trials, with the apparent death rate of 3 in 200,000.
The most recent woman to die was 25-year-old Kathleen Thoren, a mother of three who died last Thanksgiving after suffering severe headaches. The autopsy report concluded that her death was caused by the release of hormones brought on by the Ortho Evra patch, which she had started using a few weeks earlier. The youngest was 18-year-old fashion student Zakiya Kennedy, who died after collapsing in a New York subway.
Dr. Katherine LaGuardia of Ortho McNeil told the AP that her company has been researching the cases, but has not been able to find any causal factor relating the deaths to the medication. "It's difficult to reach a definitive answer, and privacy laws prevent us from investigating as thoroughly as we wish," she said.
"That number of deaths certainly sounds suspicious," said Dr. Pamela Berens, associate professor of obstetrics and gynecology at the University of Texas Medical School at Houston, in the AP article. "There may be something about the way the drug is metabolized that could increase the risk for clots."
In contrast, Dr. Daniel Shames, the FDA's director of the Division of Reproductive and Urological Drug Products, saw no cause for alarm over the recent deaths by the patch. Some doctors agree, claiming that women do not need to overreact to the deaths and, in turn, remove their patch. They said it is more risky to remove the patch and become pregnant.
“This unbelievable admission reveals a disturbing view within the medical community – that it is worse to be pregnant than dead,” said Wendy Wright, Concerned Women for America’s senior policy director. “Have any of these experts talked with the families of these women, their children left without a mother, their parents bereft of a daughter, to see if they agree that their loved one’s death is preferable to her having a child?”
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Concerned Women for America 1015 Fifteenth St. N.W., Suite 1100 Washington, D.C. 20005 Phone: (202) 488-7000 Fax: (202) 488-0806 |
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