Updates on estrogen

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MYRNA BROWN, HOST: Coming up next on The World and Everything in It: Menopause.

It’s a stage in most every woman’s life, marking the end of child-bearing years and bringing major shifts in hormones. And for decades, women have faced those changes with limited medical attention or research.

MARY REICHARD, HOST: In recent years, scientists have developed hormone therapies to treat symptoms like hot flashes and to stave off osteoporosis. But the Food and Drug Administration dampened demand for those therapies with warning labels. On Monday, FDA commissioner Dr. Marty Makary [muh-CARE-eeh] announced a change.

MAKARY: The FDA is taking action to remove the blackbox warnings from estrogen related products…

BROWN: In a press conference in Washington, Makary explained those particular warnings are rooted in research from 2002. The Women’s Health Initiative by the National Institutes of Health reported a link between the synthetic estrogen in hormone replacement therapy and breast cancer.

MAKARY: Some of us looked at it and said this is interesting. There's no statistical significance in the increase in breast cancer. If we don't have statistics then we don't have science.

REICHARD: Significant or not, headlines warning that hormone therapies could cause cancer pushed the FDA to add the strongest safety alert to every estrogen drug, even ones with different formulas and chemical pathways.

Dr. Rachel Rubin, a urologist at Georgetown University Hospital, explains.

RUBIN: The warning label on the box falsely says that vaginal estrogen causes cancer, stroke, blood clots, heart attacks, and probable dementia.

BROWN: Vaginal estrogen is usually prescribed in low doses to treat genitourinary symptoms, and has been clinically proven to not have those scary side-effects. But research from February found the FDA’s warning label has scared off many doctors and patients. Urologist Dr. Kelly Casperson says only about 1 in 20 women gets a prescription.

CASPERSON: If a patient does get a prescription from her doctor and brings it home, nearly one in three will never use it because of the fear created by the incorrect warning label.

REICHARD: Dr. Makary also touted new research showing the added benefits of hormone replacement therapy for combatting bone fractures, and coronary heart disease.

MAKARY: We talk about statins all the time. We never talk about HRT. Statins have up to a 35% reduction. And these studies are showing up to a 50% reduction. What are we doing?

BROWN: Dr. Makary and others on stage blamed groupthink for the unwarranted blanket warning, and promised to give more attention to women’s health. They also announced two new drugs for treating menopausal symptoms.

That got a warm response from many in the audience of reporters, policymakers and medical practitioners in the room.

DUANE: I'm just really excited that we recognize that the female body is well, while complex, is unique and still understandable, especially when we learn to better understand and monitor women's hormones.

REICHARD: Marguerite Duane is Associate Professor of Restorative Reproductive Medicine at Duquesne University in Pennsylvania. She told WORLD that while menopause is a stage of life like puberty or pregnancy, there are unique challenges with which doctors can help.

DUANE: …There can be dysfunction that leads to an unhealthy transition, and so in that case, we do want to provide the appropriate support.

BROWN: So are women who do not get hormone replacement therapy in menopause missing out?

STREICHER: Hormone therapy is safe and beneficial for many women. Not all women need to take it or will be in trouble if they don't take it.

BROWN: Dr. Lauren Streicher is a clinical OB-GYN professor at Northwestern University in Chicago. She’s excited to see the black-box label removed from hormone therapies, but is concerned the FDA’s tone and approach could undermine their credibility.

STREICHER: The answer is not to remove the label altogether, from my point of view and other experts, but to do this on a product by product basis.

REICHARD: Streicher points out that the possible side-effects of swallowing a pill diff from applying a skin patch. And it’s not yet clear how the range of estrogen products will be labelled.

She’s also concerned that staffing cuts at the FDA could affect the review process.

BROWN: Earlier this year, the FDA’s Center for Drug Evaluation and Research cut nearly 400 employees as part of a restructuring effort. Commissioner Makary says the agency is also bringing in more expert panels to work with the advisory committees required by law.

MAKARY: Ad-coms are bureaucratic, long, often conflicted and very expensive. So we can have an active robust discussion as a group of medical experts spontaneously. And so we're doing more of that.

REICHARD: In July, Dr. Streicher was invited to participate in the expert panel on estrogen product labelling, but after attending several preliminary meetings, she dropped out.

STREICHER: There definitely were some academic experts who've been in the space for a very long time and are very knowledgeable. And then there were people who are, quite frankly, more in the medical influencer space, who are physicians, but who do not necessarily have the kind of expertise in this world that we see in some of the experts who've been doing this for a long time.

BROWN: She acknowledges that the traditional process is cumbersome and led to decades of mislabeling for hormone therapy. But she worries the new approach could introduce more bias into how medical policies are reviewed.

STREICHER: We've seen this with Tylenol, with acetaminophen and autism. We've seen this with the vaccines. We've seen this with a lot of other things that they have basically decided who their experts are and that's biased, and it is, and it's highly problematic.

REICHARD: Back at the press conference, Dr. Duane says she has her own concerns about synthetic estrogen drugs, compared to bioidentical hormones used in natural medicine. But she is encouraged the administration is willing to challenge the medical status quo when it fails to tell the whole story.

DUANE: Like everything in medicine, we need to continue to study and do the research and make sure we are monitoring for any adverse effects to optimize health for women and minimize the risk.

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