KUDOS & a word on the FDA

Posted by Genevieve Parker on ContraceptionBlog.com

First of all, kudos to Ruben's efforts to raise awareness about the harms of birth control at the recent March for Life in Washington, D.C. As we've stressed time & again, abortion & contraception are bound up in the assault of the same principle; that is, respect for the dignity of human life, whether that be the dignity of a woman or the dignity of a pre-born child. Contraception & abortion exist on a continuum that - in principle - violates human dignity.

In other news, have a look at this recent article in the Washington Post regarding the FDA's standards for the approval of various types of hormonal contraceptives. The very first sentence of the article reads,

"The government is considering setting higher standards for birth control drugs used by millions, saying that newer pills appear to be less effective at preventing pregnancy than those approved decades ago."

Well, isn't that good to hear! Note that the article introduces the primary focus of the FDA as regards birth control as being how effective it is at preventing pregnancy, rather than how safe it is for the women who use it. The article continues:

After Tuesday's discussions, an FDA spokeswoman said the agency does not believe the effectiveness of different contraceptive drugs can be compared due to the way their clinical trials are designed.

Separately, FDA is looking at requiring manufacturers to include a more representative mix of women in the clinical trials for their new products.

Companies often exclude women who smoke, are overweight or have a history of heart problems from their trials. The FDA says this makes it difficult for scientists to judge the safety and efficacy of the drugs in the real world.

It's interesting & unfortunate that birth control studies might exclude women who smoke, are overweight or have a history of heart problems from clinical trials, particularly since female smokers make up 1/5 of the female population in the U.S., while 1/3 of women are obese, not to mention the fact that both obesity & smoking are pre-conditions for heart problems. Both statistics are fairly substantial portions of the female population ~ why would they be excluded from contraceptive research studies?

Reiterating what I've said in the past, does this not suggest some negligence on the part of both pharmaceutical companies who manufacture hormonal contraceptives & FDA in approving their unregulated use? Is this not ultimately a disservice to women? My point is, how much does the contraceptive industry really have women's health in mind? By all means, the FDA should make their approval standards more rigorous.

Cheers.


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