00:00Millions of women were told to fear the very therapy that could have given them strength, peace, and dignity through one of life's most difficult transitions, menopause.
00:24That ends today. The FDA is initiating the removal of a broad black box warnings from hormone replacement therapy products for menopause.
00:36We're challenging outdated thinking and recommitting to evidence-based medicine that empowers rather than restricts.
00:46When prescribed responsibly and started early, hormone replacement therapy transforms the lives of women.
00:53All my colleagues at the FDA, my colleagues at HHS, this is a historic day for women in the United States.
01:03The Women's Health Initiative study was the largest study ever done in U.S. history, a $1 billion study at the time.
01:10And you just heard how that study was misrepresented and created a fear machine that lingers to this day. Ask your doctor.
01:20But what you may not know is that there was an incredible backstory.
01:25The headline that hormone replacement therapy causes breast cancer was released to the media before the scientific data was released to the public.
01:35A week later, once the data was published, some of us looked at it and said, this is interesting.
01:42There's no statistical significance in the increase in breast cancer.
01:48If we don't have statistics, then we don't have science.
01:51All of a sudden, snake oil cures diseases and science goes out the window.
01:57Hi.
01:59After 23 years of dogma, the FDA today is announcing that we are going to stop the fear machine, steering women away from this life-changing, even life-saving treatment.
02:12The FDA is taking action to remove the black box warnings from estrogen-related products.
02:17This is based on a robust review of the latest scientific evidence.
02:20Our expert panel at the FDA we conducted a few months ago. Some of those doctors and experts are here with us today.
02:27We are also approving two new drugs for the treatment of menopausal symptoms.
02:32We are listening to doctors who have been waving the flag in the air saying, hey, we have this wrong.
02:38We are listening to women who have been challenging the paternalism of medicine.
02:44We are listening to female medical students that have demanded more menopause education in the curricula.
02:52This administration hears your voice and is not afraid to challenge the medical status quo.
02:59What extent does this reflect FDA scientists and consensus among others?
03:03Because until today, the warning label on the box falsely says that vaginal estrogen causes cancer, stroke, blood clots, heart attacks,
03:13and probable dementia, yet not a single scientific study shows this.
03:19And because of that warning label placed in 2003, an entire generation of clinicians were never taught the details.
03:32Companies are, generally speaking, very excited when the FDA tells them you can remove a scary warning on your product.
03:42So the process, just so you know, is that we had an expert panel.
03:48This is something I had an interest in from previous research.
03:51We let the experts express their opinions, some of whom are on stage today.
03:55And then we have our subject matter experts at the FDA do an incredible comprehensive review of the literature.
04:02The conclusion of that review was a recommendation to remove certain black box warnings.
04:06That recommendation was presented to me.
04:09I accepted it, and that makes it final.
04:11So we are letting the public know.
04:13Now the companies will reprint and accept those label changes.
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