FDA Ignores Federal Mandates on Gender Bias in Heart Device Studies

March 16, 2011

According to a new study published in the journal Circulation: Cardiovascular Quality and Outcomes, less than 50% of studies evaluating cardiac stents, pacemakers, implantable defibrillators, and other high risk cardiac devices include data on females, even though such data is mandated by the FDA’s own guidelines.

Researchers analyzed 123 studies of 78 cardiac devices that received pre-market approval from the FDA for men and women from 2000 to 2007. Of 123 studies, there was no information on the sex of participants in 28% of studies. Among those that did report gender, 67% of participants were men, on average.

The FDA had instituted a policy to analyze gender bias in all device applications, but more than half of these studies did not include such an analysis. Twelve of 47 studies that did include this summary noted that there was a difference seen in the device’s safety or efficacy in women, compared with men.

There was no uptick seen in the number of women enrolled in studies over the course of the study.”

The FDA instituted regulations requiring gender related data in 1994 but ignores their own rules.

Dr. Pam Marcovitz, Medical Director of Ministrelli Women’s Heart Center at Beaumont Hospital states ““This is 15 years after the FDA, National Institutes of Health, and Congress strongly recommended addressing gender-specific issues, and we are still treating women as small men,” she says. “We should all be outraged by this.”

Lead study author Dr. Rita Redberg:  “We think it’s important that we know that devices, particularly cardiac devices, which are often permanently implanted, are shown to be safe and effective in women as well as in men, because otherwise you [risk] exposing someone to definite harm with no known benefit, and I don’t think that’s something we want to continue.”

“We think it’s particularly important for devices, because there are substantial data that devices perform differently in women from the way they do in men. A lot of them are implanted, and there are more procedural complications in women, and women have more bleeding in general than men do,” Redberg said.

4 Responses to “FDA Ignores Federal Mandates on Gender Bias in Heart Device Studies”

  1. FAB Libber Says:

    Typical.

  2. Loup-loup garou Says:

    Funny how so many people are eager to start up the old whine, “But men and women are diiiiiiiiiiiiiiiiiiffrent, vewy, vewy diiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiiffwent!! Diiiiiffwent, I tell you!!!!” when it comes to things like temperament, which are nearly impossible to quantify, but when women’s health is on the line, they minimize or ignore straightforward biological facts. What the fuck is up with that?

    • GallusMag Says:

      So frikken true isn’t it? It only matters when it somehow benefits males.
      On that note I was extremely disturbed to come across this thread yesterday
      http://joemygod.blogspot.com/2011/03/for-those-with-vaginas.html
      About the Second City PSA about Planned Parenthood funding cuts, and surprise surprise if the convo wasn’t transjacked by males whining about how “cisprivileged” it was to equate vagina ownership with females. Jesus FUCKING Christ. Reminds me of those twans who pee in menstrual pads so they can pretend they’re cycling. I wonder if they fantasize about getting pap smears. And abortions. The cis-privilege of cervical cancer. Holy shit.

  3. Noanodyne Says:

    [D]evices perform differently in women from the way they do in men and women have more bleeding in general than men do. Yes, and:

    Women experience pain differently than men (and often have a much higher threshold for it) and therefore react to it differently, which affects medical treatment and outcomes.

    Women’s disease symptoms are sometimes different (heart attacks are one major example) and information about those differences is not well-known, so women routinely overlook symptoms until they have a much more severe medical case.

    Women are trained from birth to ignore their pain in favor of making other people more comfortable and to not be seen as complainers (and each and every one of us figures out that no one likes a woman who “complains” so it doesn’t do any good anyway because we’ll just be seen as whiners), so even when we do get some medical attention, our impulse is to not “complain” (aka, explain exactly what and how much pain or discomfort we’re in).

    Women who sense that something is wrong in their bodies, but can’t describe it in correct medical terms or “prove” it, will be dismissed by most classically-trained medical professionals (thus triggering most women’s self-correction for asking too much of the world and doubting themselves and what they’re experiencing).

    “Everyone” knows that women are hypochondriacs, so many women have to be bleeding from several orifices and at death’s door before they will ask for medical help.

    Or they have had horrible experiences in the medical establishment and will avoid getting treatment for that reason.

    And around and around and around it goes.


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