FDA Pulls Warning Labels From Hormone Replacement Therapies

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2:08Learn more at thehartford.com slash risk mitigation. Policies provided by Hartford Fire Insurance Company and its property and casualty affiliates, Hartford, Connecticut. Bloomberg Audio Studios. Podcasts, radio, news. You're listening to Bloomberg Business Week with Carol Masser and Tim Stenevek on Bloomberg Radio. We want to get to our weekly segment, Business Week Women's Health Segment, where we focus on key issues in developing technologies impacting the present and future of women's health around the world. And a lot of times it's women's health, but also even more generally a look at major health issues.

2:49And this week, though, definitely pertains to women. We're talking about hormone replacement therapies used to treat menopause symptoms, no longer needing to carry strict warnings about some potential side effects, including cancer and heart disease. That came from the U.S. Food and Drug Administration earlier in the week. Actually, on Monday it came. So we wanted to get to a voice that we've talked to before, and it's great to have her back with us. Dr. Fannie Law, she is Associate Professor of Neurology and Neuroscience at the Icahn School of Medicine at Mount Sinai. She joins us from New York City.

3:19As Carol mentioned, this week the FDA said it would remove the black box warnings from HRT products. The last time you were on the show with us, you said HRT may actually help diminish women's risk of dementia. What are your views on just the warning or the changing warnings coming from the federal government on this? Net-net, a good thing? So I want to qualify that statement by I hope that it will diminish the risk of dementia. I am delighted by the fact that this warning that I and many others think was never warranted was finally lifted. It's sad that we lost two decades. And during this time, many women did not get the chance to go on hormone replacement therapy due to the fear of the side effects that were not indicated.

4:06But I think now we need to make up for the lost time and advance the science to the point where we are more precise with our predictions. Why were those statements there in the first place? If we go back in history, you said we lost it's unfortunate that we lost 20 years of treatment here. Why do those those come around in health care in the U.S. in the first place? It was unfortunately a flawed design. Hormone replacement therapy was started for women who had gone through menopause in their 50s. And it wasn't until mid 60s that hormone replacement therapy was started. By then, it's too late. The physiology has drastically changed.

4:52A decade has gone by. And the impact of hormones may no longer have the impact on the health span that we need them to have. And then you just deal with the side effects. Wait, so I'm confused. You're saying not as dangerous. So and what a shame that women weren't allowed to use them earlier because there were these concerns and warnings on it. Right. So what I'm saying is that the timing of the hormone replacement therapy that was tested in the WHI, the Women's Health Initiative study, was wrong. timing of treatment is really critical. This is not just for hormones, for any kind of treatment.

5:36You cannot wait years when disease has truly evolved, where the physiological state is different, and then test the impact of your intervention. It's like having a treatment for Alzheimer's disease for the early, you know, most, maybe even preclinical stage of disease, but waiting until full-blown dementia to test it. This is no different. Hormone replacement. Yeah. Well, so Dr. Lahi, when should women start talking to their primary care physicians about hormone replacement therapy? Right around menopause. It's really, really important. And this is really a point that I hope people hear and start doing.

6:20When people are thinking that there may be perimenopausal, that's when the conversation starts, or even before, as you're preparing. to approach the age at which you may go through menopause or early post menopause. We don't actually know how many years can go by before you start hormone replacement therapy. We definitely know a decade is too much. And I would say as early as possible is probably the smartest move. Wait, so let me go back to, because I do think it's safe to say, you know, as a woman, Like there has been that fear when it comes to hormone replacement therapy. So the concerns about cancer, heart disease, that's just not a reality.

7:05There is one kind of cancer that can the risk for which can increase that's uterine cancer. If people are taking only estrogen, this is an important point. If women are considering to take only estrogen, they need to be aware that they need to get very close monitoring. if they still have their uterus. But most hormone replacement therapy are of combination pills. The risk of heart disease, that was just because these were older women and the formulation that was used, the route would also matter. Oral estrogen therapy can increase the risk of coagulation and perhaps other things. So route of administration matters.

7:51Timing of administration really matters. And I would say that we are actually still in the dark with regards to the duration of the administration. That's a really important question remaining to be answered. So what should most women be asking themselves right now in regards to hormone replacement therapy? They need to be having the conversations with their providers and think about each. The providers would need to be thinking about each woman on an individual level. There are pros and cons to every treatment. And hormone replacement therapy in general, no longer are considered risky. And in fact, we think could be really beneficial in the right clinical setting.

8:39If someone has a really high risk for various kinds of cancers, that would need to be taken into account. And the kind of hormone replacement therapy that is being administered would need to be investigated very closely. Women in general are at higher risk for various kinds of cancers, so the routine screening and care does not change. The fact that getting hormone replacement therapy after menopause increases independent of any other risk factors, your risk for breast cancer is no longer true. Interesting. I know we're not supposed to do this, but will you be my doctor? No, it's just... I will be delighted.

9:20Okay. But I'm a brain specialist. I will take care of your brain. Okay. We only have about 30 seconds left, but I do want to know why you think hormone replacement therapy is having a moment right now after so many years of it being questioned by medical professionals.

9:37I'm really delighted because I think we live in an era of precision medicine, And this is one of the many changes that I hope to see implemented in healthcare, where we design the studies really well. But I hope that in the future, we don't make conclusions on group levels anymore either, and that we have biomarker strategies. This is what my lab is really focused on, to make treatment precise for that given individuals to decrease their risk and to maximize their benefit. Will you be all of our doctors? so appreciate it already looking forward to next time Dr. Fannie Allahi she is Associate Professor of Neurology and Neuroscience at the Icahn School of Medicine at Mount Sinai joining us right here in New York City you got to make sure she accepts your insurance I know you didn't check this might be one you pay out of pocket for I'm just saying all right this is never bet against American grit or American energy Through innovation, Venture Global is not only building some of the largest energy facilities in the world right here in the United States, but delivering American energy at a fraction of the cost and a fraction of the time.

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