When Ortho Evra, more commonly known as the birth control patch, hit the market in 2002, it received high praise, being called one of the best inventions of the year and garnering almost 40 million prescriptions. However, it also delivered a fatal dose of estrogen, causing the death of 20 women and injuring 2,400. And while the women who used the patch were unaware of the grave risks, newly uncovered internal documents show that Johnson & Johnson executives knew, and neither disclosed the risks nor took any steps to change the product.

According to patient reports from 2002 to 2004, the patch is 12 times more likely to cause strokes and 18 more times likely to cause blood clots than the birth control pill. The reason, according to experts, is that the patch delivers a high level of estrogen into the bloodstream continuously during the week it is worn. Comparatively, the pill has 60 percent less estrogen and quickly dissolves into the bloodstream, creating much lower risk of blood clots and other injuries.

When Johnson & Johnson Vice President Dr. Patrick Caubel resigned from the company in 2005, his resignation letter indicated that he and other executives were aware of the high risks. "I have been involved in the safety evaluation of Ortho Evra since its introduction on the market," he said. "The estrogenic exposure of the patch was unusually high, as was the rate of fatalities." Caubel concluded the letter by saying that because of the "compelling evidence" that the company continued to ignore, "it became impossible for me to stay in my position as VP."

In response to growing concerns about the patch, in 2006 Johnson & Johnson added a fine print warning to the patch's packaging, informing users of the increased levels of estrogen and outlining its own study showing a doubling of the risk of blood clots.

According to Leslie Niedner, the mother of a patch user who suffered a fatal blood clot, the warning is gravely insufficient in informing its users of the risks. "There is nothing in that warning that could help me understand that a patch would kill a healthy young 17-year-old woman," she said. Niedner has filed a lawsuit against Johnson & Johnson.

Source: Today, "Did drugmaker hide birth control patch risks?", Jeff Rossen and Robert Powell, 22 September 2010