WEBVTT - FDA Pulls Warning Labels From Hormone Replacement Therapies

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<v Speaker 1>Bloomberg Audio Studios, Podcasts, radio News. You're listening to Bloomberg

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<v Speaker 1>Business Week with Carol Masser and tim Stenoveek on Bloomberg Radio.

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<v Speaker 2>We want to get to our weekly segment, BusinessWeek Women's

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<v Speaker 2>Health segment, where we focus on key issues in developing

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<v Speaker 2>technologies impacting the present and future of women's health around

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<v Speaker 2>the world. And a lot of times it's women's health,

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<v Speaker 2>but also even more generally a look at major health issues.

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<v Speaker 2>And this week, though definitely pertains to women, we're talking

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<v Speaker 2>about hormone replacement therapies used to treat menopause symptoms no

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<v Speaker 2>longer needing to carry strict warnings about some potential side effects,

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<v Speaker 2>including cancer and heart disease, that came from the US

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<v Speaker 2>Food and Drug Administration earlier in the week, actually on

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<v Speaker 2>Monday it came. So we wanted to get to a

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<v Speaker 2>voice that we've talked to before, and it's great to

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<v Speaker 2>have her back with us.

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<v Speaker 1>Doctor Fanny Lawi is Associate Professor of Neurology and neuroscience

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<v Speaker 1>at the Icon School of Medicine at Mount Science and

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<v Speaker 1>now she joins US from New York City. As Carol mentioned,

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<v Speaker 1>this week, the FDA said it would remove the black

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<v Speaker 1>box warnings from HRT products. The last time you're on

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<v Speaker 1>the show with us, you said HRT may actually help

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<v Speaker 1>diminish women's risk of dementia. What are your views on

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<v Speaker 1>just the warning or the changing warnings coming from the

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<v Speaker 1>federal government on this net a good thing.

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<v Speaker 3>So I want to qualify that statement by I hope

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<v Speaker 3>that it will diminish the risk of dementia. I am

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<v Speaker 3>delighted by the fact that this warning that I and

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<v Speaker 3>many others think was never warranted, was finally lifted. It's

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<v Speaker 3>sad that we lost two decades, and during this time

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<v Speaker 3>many women did not get the chance to go on

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<v Speaker 3>hormone replacement therapy due to the fear of the side

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<v Speaker 3>effects that were not indicated.

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<v Speaker 4>But I think now we need to make.

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<v Speaker 3>Up for the lost time and advance the science to

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<v Speaker 3>the point where we are more precise with our predictions.

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<v Speaker 1>Were those statements there in the first place? If we

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<v Speaker 1>go back in history, you said we lost it's unfortunate

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<v Speaker 1>that we lost twenty years of treatment here, Why do

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<v Speaker 1>those come around in healthcare in the US?

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<v Speaker 3>In the first place, it was unfortunately a flawed design.

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<v Speaker 3>Hormone replacement therapy was started for women who had gone

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<v Speaker 3>through metopause in their fifties, and it wasn't until mid

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<v Speaker 3>sixties that hormone replacement therapy was started.

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<v Speaker 4>By then, it's too late.

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<v Speaker 3>The physiology has drastically changed, A decade has gone by,

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<v Speaker 3>and the impact of hormones may no longer. The hormones

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<v Speaker 3>may no longer have the impact on the health span

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<v Speaker 3>that we need them to have, and then you just

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<v Speaker 3>deal with the side effects.

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<v Speaker 2>Wait, so I'm confused. So you're saying not as dangerous. So,

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<v Speaker 2>and what a shame that women weren't allowed to use

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<v Speaker 2>them earlier because there were these concerns and warnings on it.

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<v Speaker 3>Right, So, what I'm saying is that the timing of

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<v Speaker 3>the hormone replacement therapy that was tested in the w HI,

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<v Speaker 3>the Women's Health Initiative study, was wrong. Timing of treatment

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<v Speaker 3>is really critical. This is not just for hormones. For

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<v Speaker 3>any kind of treatment, you cannot wait years when disease

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<v Speaker 3>has truly evolved, where the physiological state is different, and

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<v Speaker 3>then test the impact of your intervention. It's like having

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<v Speaker 3>a treatment for Alzheimer's disease for the early.

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<v Speaker 4>You know, most.

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<v Speaker 3>Maybe even pre clinical stage of disease, but waiting until

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<v Speaker 3>full blown dementia to test it. This is no different

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<v Speaker 3>so doctor replacement.

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<v Speaker 1>Yeah yeah, well so doctor Lowie. When should women start

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<v Speaker 1>talking to their primary care physicians about hormone replacement therapy.

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<v Speaker 3>Right around menopause? It's it's really really important, and this

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<v Speaker 3>is really a point that I hope people here and

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<v Speaker 3>start doing. When people are thinking that there may be

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<v Speaker 3>perimenopausal that's when the conversation starts, or even before, as

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<v Speaker 3>you're preparing to approach the age of which you may

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<v Speaker 3>go through menopause or early post menopause.

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<v Speaker 4>We don't actually know how many.

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<v Speaker 3>Years can go by before you start hormone replacement therapy.

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<v Speaker 3>We definitely know a decade is too much, and I

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<v Speaker 3>would say as early as possible is probably the smartest move.

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<v Speaker 2>Wait, so let me go back to because I do

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<v Speaker 2>think it's safe to say, you know, as a woman

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<v Speaker 2>like there has been that fear when it comes to

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<v Speaker 2>hormone replacement therapy. So the concerns about cancer, heart disease,

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<v Speaker 2>that's just not a reality.

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<v Speaker 3>There is one kind of cancer that can the risk

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<v Speaker 3>for which can increase.

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<v Speaker 4>That's utter in cancer.

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<v Speaker 3>If people are taking only estrogen, this is an important point.

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<v Speaker 3>If women are considering to take only estrogen, they need

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<v Speaker 3>to be aware that they need to get very close

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<v Speaker 3>monitoring if they still have their uterus. But most hormon

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<v Speaker 3>replacement therapy are of combination pills. The risk of heart disease.

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<v Speaker 3>That was just because these were older women and the

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<v Speaker 3>formulation that was used.

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<v Speaker 4>The route would also matter.

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<v Speaker 3>Oral estrogen therapy can increase the risk of coagulation and

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<v Speaker 3>perhaps other things. So route of administration matters, Timing of

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<v Speaker 3>administration really matters, and I would say that we are

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<v Speaker 3>actually still in the dark with regards to the duration

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<v Speaker 3>of the administration. That's a really important question remaining to

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<v Speaker 3>be answered.

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<v Speaker 2>So what should most women be asking themselves right now

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<v Speaker 2>in regards to hormone replacement therapy.

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<v Speaker 3>They need to be having the conversations with their providers

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<v Speaker 3>and think about each The provider would need to be

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<v Speaker 3>thinking about each woman on an individual level, their pros

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<v Speaker 3>and cons to every treatment, and hormone replacement therapy in

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<v Speaker 3>general no longer are considered risky and in fact, we

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<v Speaker 3>think could be really beneficial.

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<v Speaker 4>In the right clinical setting.

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<v Speaker 3>If someone has a really high risk for various kinds

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<v Speaker 3>of cancers, that would need to be taken into account,

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<v Speaker 3>and the kind of hormone replacement therapy that is being

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<v Speaker 3>administered would need to be investigated very closely. Women in

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<v Speaker 3>general are at higher risk for various kinds of cancers,

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<v Speaker 3>so the routine screening and care does not change the

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<v Speaker 3>fact that getting hormone replacement therapy after menopause increases, independent

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<v Speaker 3>of any other risk factors, your risk for breast cancer

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<v Speaker 3>is no longer true.

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<v Speaker 2>Interesting. I know we're not supposed to do this, but

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<v Speaker 2>will you be my doctor?

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<v Speaker 4>No, it's'll just be delighted.

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<v Speaker 2>Okay, but I'm.

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<v Speaker 4>A brain specialist. I will take care of your brain. Okay,

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<v Speaker 4>really help with that.

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<v Speaker 1>We only have about thirty seconds left. But I do

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<v Speaker 1>want to know why you think hormone replacement therapy is

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<v Speaker 1>having a moment right now after so many years of

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<v Speaker 1>it being questioned by medical professionals.

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<v Speaker 3>I'm really delighted because I think we believe that in an

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<v Speaker 3>era of precision medicine, and this is one of the

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<v Speaker 3>many changes that I hope to see implemented in healthcare

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<v Speaker 3>where we design.

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<v Speaker 4>The studies really well.

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<v Speaker 3>But I hope that in the future we don't make

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<v Speaker 3>conclusions on group levels anymore either, and that we have

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<v Speaker 3>biomarker strategies. This is what my LIBE is really focused on,

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<v Speaker 3>to make treatment precise for that given individuals, to decrease

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<v Speaker 3>their risk and to maximize their benefit.

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<v Speaker 2>Will you be all of art doctors so appreciate it.

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<v Speaker 2>I already looking forward to next time. Doctor Fanny Alahi.

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<v Speaker 2>She is Associate Professor of Neurology and your Science at

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<v Speaker 2>the Icon School of Medicine at Mount Sinai, joining us

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<v Speaker 2>right here in New York City.

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<v Speaker 1>You got to make sure she accepts your insurance. I

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<v Speaker 1>know you didn't check.

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<v Speaker 2>This might be one you pay out a pocket for.

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<v Speaker 2>I'm just saying, all right, this is Boomberg