Thursday, September 23, 2004

Ortho Evra Report Not Ready for Primetime

I received a lot of e-mails asking me to comment on last night's ABC Primetime report Call for Increased Warning
Do Users of the Birth Control Patch Know Enough About Its Potential Dangers?
about the birth control skin patch, Ortho Evra. From the transcript, these are the facts:

  • "Based on our best estimates, less than two per 100,000 women less than the age of 35" will die from complications of the patch, said Dr. Shaun Biggers of New York Presbyterian Hospital in New York.

  • So, we have an estimated risk of death from using the patch of less than 2 per 100,000 women.

  • But 17 deaths and 62 life-threatening complications like blood clots might be related to patch use, according to adverse event reports received by the Food and Drug Administration.

    The FDA has not concluded its investigation. It says some of those reported deaths may not be linked to the patch and some may be duplications.

  • We have a number of deaths in patch users that may, or may not be related to using the patch. We also don't know what the actual number of deaths is--maybe 17, maybe less--since some may be duplications.

  • The patch has been used by 4,000,000 women.

    So, if we speculate and assume that 1) the deaths observed so far in patch users were, indeed, caused by the patch, and 2) the number of deaths is actually 17, we have an actual risk of death from using the patch of less than 1 (0.425) per 100,000 women.

    Conclusion: based on the information provided by the ABC report, it appears that the actual risk of death from using the patch is lower than the estimated risk. Very good news, indeed, for patch users.

    Of course, the puzzling thing about the report is the disconnect between its message and its facts: the call for an increased warning about the patch's serious side effects in light of the reduced risk of death experienced by patch users. Even if, as ABC reports, you have a lower risk of death from using the patch than previously estimated, once you decide to use the patch, or any birth control method for that matter, you should be aware of its side effects.

    There are two possible explanations for the disconnect in ABC's report: the facts and figures are wrong and the [speculative] observed risk of death for patch users isn't actually lower than the estimated one, or Primetime is clueless, and/or there's a class action suit against the patch manufacturer in the works, and ABC has decided, for whatever reason, to prime the jury pool with discombobulated reports.

    I called Ortho-McNeil (908-927-3672), the patch manufacturer, and I'm waiting for them to call back and confirm the facts and figures.

    Update: The Ortho-McNeil medical info person called back and confirmed the numbers (with the standard disclaimers: link to patch not established, total number of users is an estimate, etc.). And still, the ABC report doesn't make sense.

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    At 8:56 PM, Anonymous Anonymous said...

    I wonder how many of those deaths were smokers over 35.


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