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Jennifer Gunter

đŸ‘€ Person
484 total appearances

Appearances Over Time

Podcast Appearances

Ground Truths
Jennifer Gunter & Eric Topol - Discuss Women’s Health and Recent Changes by FDA for MHT

People were prescribing it to 75-year-olds for heart disease.

Ground Truths
Jennifer Gunter & Eric Topol - Discuss Women’s Health and Recent Changes by FDA for MHT

So this trial was designed to answer the question, should we be doing that?

Ground Truths
Jennifer Gunter & Eric Topol - Discuss Women’s Health and Recent Changes by FDA for MHT

And so it's very easy for us to go back and sort of say, well, they're the wrong women.

Ground Truths
Jennifer Gunter & Eric Topol - Discuss Women’s Health and Recent Changes by FDA for MHT

But that was what it was designed to do because that's what people were doing.

Ground Truths
Jennifer Gunter & Eric Topol - Discuss Women’s Health and Recent Changes by FDA for MHT

And, you know, it was designed for everybody to be after menopause because if you give people who are still menstruating hormones, you're going to make them bleed irregularly.

Ground Truths
Jennifer Gunter & Eric Topol - Discuss Women’s Health and Recent Changes by FDA for MHT

And now you've unblinded your study.

Ground Truths
Jennifer Gunter & Eric Topol - Discuss Women’s Health and Recent Changes by FDA for MHT

Right.

Ground Truths
Jennifer Gunter & Eric Topol - Discuss Women’s Health and Recent Changes by FDA for MHT

So you needed to get people who were at least a year postmenopause.

Ground Truths
Jennifer Gunter & Eric Topol - Discuss Women’s Health and Recent Changes by FDA for MHT

So you weren't going to, you know, be causing bleeding.

Ground Truths
Jennifer Gunter & Eric Topol - Discuss Women’s Health and Recent Changes by FDA for MHT

But also they ideally wanted people who didn't have hot flashes.

Ground Truths
Jennifer Gunter & Eric Topol - Discuss Women’s Health and Recent Changes by FDA for MHT

So they're a very small percentage of those, because if you're taking a drug and all of a sudden your hot flashes go away, you're like, well, maybe I was getting the medication.

Ground Truths
Jennifer Gunter & Eric Topol - Discuss Women’s Health and Recent Changes by FDA for MHT

Right.

Ground Truths
Jennifer Gunter & Eric Topol - Discuss Women’s Health and Recent Changes by FDA for MHT

So it was really designed to answer that question.

Ground Truths
Jennifer Gunter & Eric Topol - Discuss Women’s Health and Recent Changes by FDA for MHT

And people have gone back and then looked at like the 50 to 59 year old age group and tried to sort of to get the data out from there.

Ground Truths
Jennifer Gunter & Eric Topol - Discuss Women’s Health and Recent Changes by FDA for MHT

And even when you look at those groups, the benefits are not there to recommend it as preventative therapy.

Ground Truths
Jennifer Gunter & Eric Topol - Discuss Women’s Health and Recent Changes by FDA for MHT

Because you have to also remember when we're talking about the 13-year, 18-year follow-up, we're talking about five years or seven years of drug now with 13 years of observational data afterwards, right?

Ground Truths
Jennifer Gunter & Eric Topol - Discuss Women’s Health and Recent Changes by FDA for MHT

So might people change their behaviors because they were given a drug that at the time they thought was harmful?

Ground Truths
Jennifer Gunter & Eric Topol - Discuss Women’s Health and Recent Changes by FDA for MHT

So, you know, we have to, we just have to be careful about what we say we know for sure based on that.

Ground Truths
Jennifer Gunter & Eric Topol - Discuss Women’s Health and Recent Changes by FDA for MHT

Well, we do.

Ground Truths
Jennifer Gunter & Eric Topol - Discuss Women’s Health and Recent Changes by FDA for MHT

We have, so we have, ELITE was oral estradiol, I believe, and then we have KEEPS, which was a different dose of permarin, I think it was 0.45, and then it was transdermal, 15-microgram patch.