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Birth Control Patch Still Killing Women 2 Years After FDA Review

When I saw the Today Show's exposé of Johnson & Johnson (JNJ)'s Ortho Evra birth control patch -- it fills women with an uninterrupted flow of hormones that create lethal blood clots -- my first reaction was, this is an old story. I've been banging on about the dangers of Ortho Evra since 2007. J&J stopped actively marketing the product years ago. Why are they rehashing it now? Here's the real reason, per NBC:

Public Citizen's Sydney Wolfe petitioned the FDA two years ago to pull the patch off the market, but the FDA has yet to make a decision.
The FDA told NBC:
It's a complicated issue that takes time to review.
In the meantime, girls are still -- literally -- dropping dead from the patch, such as Adrianna Duffy, a college freshman who collapsed in September 2009.

The FDA is running out of excuses for not making a decision about Ortho Evra. The history is a long one, and it reflects badly on J&J:

  • The patch has killed more than 40 women.
  • J&J has settled thousands of Ortho Evra lawsuits.
  • When the brand was launched in 2002, J&J's ads frequently carried no warnings.
  • A J&J physician on the brand had a history of faking test results.
  • When a patient at New York's Mount Sinai adolescent health center died from an Ortho Evra blood clot, J&J sales reps triples their visits to the staff there, treating them to breakfast and lunch until their concerns went away.
  • An FDA staffer reviewing J&J's application to market the drug warned that the blood clot risks were actually twice what J&J's stats said they were.
Although J&J doesn't promote the brand any more, it still sells the drug and doctors still prescribe it for women who say they are forgetful about pills. Here's J&J's statement. There are safer, equally effective products on the market. The revenue is generates for J&J is so small it is not mentioned in the company's most recent 10-Q. J&J should not wait for the FDA: Ortho Evra should be removed from the market before it kills anyone else.


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