Sunday, November 13, 2005

Warning on Patch                                                                               I didn't see enough media coverage on this warning so I'm posting it here. This is really bad news for teens especially and for worried parents of teens. The FDA issued a warning on Thursday on the Ortho-Evra contraceptive patch, finding that it raises the risk of life-threatening blood clots to three times that of regular oral contraceptives. There's a risk with oral contraceptives too, but the patch does not deliver estrogen evenly through the week and it turns out more is absorbed through the skin than in the case of oral contraceptives where absorption happens in the digestive tract. Given that millions use the patch, individual risk in either case is low, but real.  In 2004, according to the AP, a dozen girls and women died of blood clots that are thought to be related to patch use. The reason I bring up teens is that for forgetful girls ---and you know you are -- using a once-a-week patch makes it less likely that you'll be going unprotected than if you have to remember every single day to take a pill. So now with a clutch in my stomach I'm doing the risk/benefit calculations in my head for my daughter. What are the risks of this patch vs. the risk of forgetting oral contraception vs. the real medical and psychological risks of either pregnancy or abortion? And don't talk to me about abstinence. That's not a contraceptive option. The FDA recommends women and girls speak to their doctors about whether to stop using the patch and to make sure you've got another plan lined up. Now my questions turn to Ortho McNeil, the manufacturer, which apparently knew two years ago about this added risk but refused an FDA request to study it. According to the AP, an internal Ortho McNeil memo shows that, in 2003, the company refused to fund a study comparing its Ortho Evra patch to its Ortho-Cyclen pill because of concerns there was "too high a chance that study may not produce a positive result for Evra" and there was a "risk that Ortho Evra may be the same or worse than Ortho-Cyclen."   Does this shock you? It shouldn't; this is how pharmaceutical companies do their own risk/benefit analyses. How hard can it be to make a good patch that delivers the hormone evenly and in the right dose? More expensive to make maybe? Not as profitable? I hope we can put the heat on the company and the FDA to do better by us. This is an old story. -RH 12:09:45 PM    comment []

Too Pretty A Picture            For those wondering if feminism is dead or even still necessary, read E.J.Graff's tour of sexual harrassment in the workplace as she reviews the new Charlize Theron movie "North Country" in today's Washington Post. She quotes court documents with all the horrific details that were not depicted in the movie, and she's got a laundry list of companies and settlements of similar class action suits for what she calls "gruesome violations of the law" that roll right up into today's calendar. -RH   11:12:35 AM    comment []

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