Tuesday, December 07, 2004

Ortho Evra Report: CBS Misses

A few months ago ABC had a report on the birth control skin patch, Ortho Evra (see here, and here). Yesterday, CBS Evening News with Dan Rather ran a segment on the patch and new safety questions about it. Here are the notes I made during the report:

DR: She suffered a massive stroke. Was, or was not the patch to blame?

DR: 800,000 estimated patch users ... patch has same benefits/risks as Pill, but is patch equally safe?

Reporter: 38 yo beautician suffered near fatal stroke ... her MD couldn't find cause of stroke ... he suspected condition could have been caused by patch ... she started using the patch only 12 days earlier...

Attorney representing the woman's family, and other families: FDA has records on as many as 11 deaths in patch users ... using a bc method is a balancing task, however there are safer contraceptives available ... he has already filed lawsuit [can you say class action suit?]

Reporter: FDA has 46 reports of serious clots and deaths in women using patch, but only 23 for the Pill...

My quick impression of the report: not educational, almost devoid of useful practical information, and potentially harmful because of incorrect factual information.

Factually incorrect:

  • patch has been used by about 4 million women (x2 years)

  • only 6 reported deaths since April 2002 (when the patch was introduced)

  • to date no link between the patch and any of the 6 deaths

  • Not educational/almost devoid of practical information:

  • no quick primer on the cause-effect mechanism [how would the patch cause stroke], and/or the methods used to determine if a link exists [what would we need to know in order to make a determination that patch users have an increased risk of stroke; is it even possible for a 12-day use to cause a stroke; what type of studies give us the best information*; etc.]

  • the only practical information was given by the doctor interviewed for the piece: all women should know their stroke risk

  • In the end, the report's stated goal to inform us about new safety questions concerning patch use was not achieved. Regrettably, yet another opportunity to educate women about a method of birth control has been squandered.

    * Here's a listing of study types, starting with the ones with the strongest evidence first:

    Experimental studies (randomized)

  • controlled clinical trial

  • cross-over clinical trial

  • controlled laboratory study

  • Observational studies

  • cohort

  • case-control

  • cross-sectional

  • case series

  • case report

  • The case report is basically a personal experience observed and reported by a physician, and it is a media darling. Unfortunately, the evidence it provides for a cause and effect relationship is limited, at best.

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