“That Ends Today”: RFK Jr. on Move to Drop Black Box Warnings on Menopause Hormone Therapy

In a landmark decision, the U.S. Food and Drug Administration will remove the strictest “black box” warnings from hormone therapies used to treat menopause. U.S. Health Secretary Robert F. Kennedy Jr. hailed the move as “a victory for evidence-based medicine,” saying millions of women were misled into fearing treatments that could have improved their quality of life. The FDA says it’s time to update science and end stigma in women’s health.

#FDA #RFKJr #RobertFKennedyJr #Menopause

Transcript

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.

00:23That ends today. The FDA is initiating the removal of a broad black box warnings from hormone replacement therapy products for menopause.

00:35We're challenging outdated thinking and recommitting to evidence-based medicine that empowers rather than restricts.

00:45When prescribed responsibly and started early, hormone replacement therapy transforms the lives of women.

00:52All 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.

01:21But what you may not know is that there was an incredible back story.

01:26The 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.

01:47If we don't have statistics, then we don't have science.

01:50All of a sudden, snake oil cures diseases and science goes out the window.

01:56After 23 years of dogma, the FDA today is announcing that we are going to stop the fear machine,

02:07steering women away from this life-changing, even life-saving treatment.

02:11The FDA is taking action to remove the black box warnings from estrogen-related products.

02:16This is based on a robust review of the latest scientific evidence.

02:19Our expert panel at the FDA we conducted a few months ago.

02:23Some of those doctors and experts are here with us today.

02:26We are also approving two new drugs for the treatment of menopausal symptoms.

02:31We are listening to doctors who have been waving the flag in the air saying,

02:36hey, 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.

02:51This administration hears your voice and is not afraid to challenge the medical status quo.

02:58What extent does this reflect FDA scientists and consensus among them?

03:03Because until today, the warning label on the box falsely says that vaginal estrogen causes cancer, stroke, blood clots, heart attacks, and probable dementia.