Ortho Evra- The Rest of the Story

It was at Thanksgiving time last year that Kathleen Thoren, a 25-year-old mother of three, died after days of severe headaches that, according to the medical examiner, were provoked by hormones released into her system by Ortho Evra — the once a week birth control patch.
In 2005 alone, about one dozen women died from blood clots believed to be related to Ortho Evra with dozens more surviving strokes and other clot-related problems. These women were largely young and not at risk for clots. Women like Zakiya Kennedy, an 18-year-old Manhattan fashion student who collapsed and died in a New York subway station in April 2004, and Sasha Webber, a 25-year-old mother of two who died of a heart attack after six weeks on the patch.
The Associated Press analyzed federal drug safety reports, finding that women using the patch are at a triple risk of dying or suffering a survivable blood clot compared to women using birth control pills.
The US Food and Drug Administration (FDA) approved Ortho Evra in November 2001 as the first birth control skin patch. But long before the patch reached the marketplace in 2002 both the FDA and Ortho McNeil, the Johnson & Johnson company that manufactures Ortho Evra, saw warning signs of possible problems. The FDA had already noticed that nonfatal blood clots occurred three times more frequently than the pill. Blood clots in the lungs were seen in two women given Ortho Evra in clinical trails conducted before the drug was approved – in addition to many similar cases in women after the drug was marketed. According to Public Citizen, drugs rarely present such strong evidence of a serious problem during randomized pre-approval studies.
Ortho Evra contains two hormones: an estrogen and a progestin. Most pills and the patch contain the same amount of estrogen, but hormones from the patch go straight to the bloodstream while pills are swallowed and digested, losing half the estrogen dose. Women using the patch are exposed to high levels of estrogen 24 hours a day. Associate Professor of Obstetrics and Gynecology at the University of Washington, Dr. Leslie Miller has reported that women using the patch absorb significantly more estrogen than the pill, adding the elevated levels may be high enough to increase some women’s risk of blood clots.
On November 10 the FDA updated labeling for the Ortho Evra birth control path to warn healthcare providers and patients that this product exposes women to higher levels of estrogen (about 60 percent more) than the pill. But not all physicians waited for the new label to take action. In October, Dr. Miguel Cano, an obstetrician and gynecologist in Reedley, California, sent a note to several thousand patients recommending that the stop using the patch and that they come in for appointments to get a new form of contraception. On the website worstpills.com Public Citizen proclaims: “There is no medical reason for women to use the more dangerous Ortho Evra rather than one of the older, better understood, and equally effective oral contraceptives.” Public Citizen’s Health Research Group added Ortho Evra to its ongoing list of dangerous medicines.
Catchy ads featuring Olympic beach volleyball players and supermodel Namoi Campbell — resulted in more than five million US women trying the patch in less than three years. In 2004 Ortho Evra sales topped $411 million for 9.9 million prescriptions, accounting for 15 percent of the US market. In July 2005 J & J CFO Robert J. Daretta reported no sign of increased safety problems with the Ortho Evra birth control patch. Obviously Mr. Daretta did not foresee the increased label warnings.