FDA Pulls Warning Labels From Hormone Therapies

Bloomberg

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00:00The last time you were on the show with us, you said HRT may actually help

00:03diminish women's risk of dementia. What are your views on just the warning or the changing warnings

00:09coming from the federal government on this? Net-net, a good thing?

00:14So I want to qualify that statement by, I hope that it will diminish the risk of dementia.

00:20I am delighted by the fact that this warning that I and many others think was never warranted

00:27was finally lifted. It's sad that we lost two decades. And during this time, many women did

00:34not get the chance to go on hormone replacement therapy due to the fear of the side effects that

00:40were not indicated. But I think now we need to make up for the lost time and advance the science

00:47to the point where we are more precise with our predictions. Why were those statements there

00:53in the first place? If we go back in history, you said it's unfortunate that we lost 20 years

00:59of treatment here. Why do those come around in healthcare in the U.S. in the first place?

01:07It was unfortunately a flawed design. Hormone replacement therapy was started for women who

01:14had gone through menopause in their 50s. And it wasn't until mid-60s that hormone replacement

01:20therapy was started. By then, it's too late. The physiology has drastically changed. A decade has

01:27gone by. And the impact of hormones may no longer have the impact on the health span that we need

01:37them to have. And then you just deal with the side effects. Wait, so I'm confused. You're saying

01:43not as dangerous. And what a shame that women weren't allowed to use them earlier because there

01:49were these concerns and warnings on it? Right. So what I'm saying is that the timing of the hormone

01:57replacement therapy that was tested in the WHI, the Women's Health Initiative study, was wrong. Timing of

02:06treatment is really critical. This is not just for hormones, for any kind of treatment. You cannot wait,

02:13years, when disease has truly evolved, where the physiological state is different, and then test

02:20the impact of your intervention. It's like having a treatment for Alzheimer's disease for the early,

02:27you know, most, maybe even preclinical stage of disease, but waiting until full-blown dementia to

02:36test it. This is no different. So Dr. Lahi, when should women start

02:43talking to their primary care physicians about hormone replacement therapy?

02:47Right around menopause. It's really, really important. And this is really a point that I hope

02:52people hear and start doing. When people are thinking that there may be perimenopausal,

02:59that's when the conversation starts, or even before, as you're preparing to approach the age at which you

03:06may go through menopause or early post-menopause, we don't actually know how many years can go by

03:14before you start hormone replacement therapy. We definitely know a decade is too much. And I would

03:19say as early as possible is probably the smartest move.

03:24Wait, so let me go back to, because I do think it's safe to say, you know, as a woman, like there has

03:30been that fear, um, when it comes to hormone replacement therapy. So the concerns about cancer,

03:36heart disease, that's just not a reality.

03:40There is one kind of cancer, uh, that can, uh, the risk for which can increase that's uterine cancer.

03:48If people are taking only estrogen, this is an important point. If, uh, women are considering to

03:55take only estrogen, they need to be aware that they need to get very close monitoring. If they still

03:59have their uterus, um, but most hormone replacement therapy are of combination pills,

04:05the risk of heart disease, that was just because these were older women and the formulation that

04:11was used, the route would also matter. Oral estrogen therapy can increase the risk of coagulation

04:20and perhaps other things. So route of administration matters. Timing of administration really matters.

04:28And I would say that we are actually still in the dark with regards to the duration of the

04:34administration. That's, that's a really important question remaining to be answered.

04:39So what should most women be asking themselves right now in regards to hormone replacement therapy?

04:45They need to be having the conversations with their providers and think about each,

04:50the providers would need to be thinking about each woman on an individual level. There are pros and cons

04:58to every treatment. Um, and hormone replacement therapy in general, no longer are considered risky.

05:07And in fact, we think could be really beneficial in the right clinical setting. If someone has a really

05:15high risk for various kinds of cancers that would need to be taken into account and the kind of hormone

05:22replacement therapy that is being administered would need to be investigated very closely.

05:27Women in general are at higher risk for various kinds of cancers. So the routine screening and care

05:33does not change. The fact that getting hormone replacement therapy after menopause increases,

05:41independent of any other risk factors, your risk for breast cancer is no longer true.

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