The "65-and-Out Rule" Was Never Valid, and Is Now Disappearing

Synopsis: This article by Dr. Daved Rosensweet dismantles the “lowest dose, shortest time, stop at 65” doctrine that emerged from widespread media misrepresentation of the 2002 Women’s Health Initiative study, revealing that the actual data showed no statistically significant breast cancer risk and that the 2017 retraction published in JAMA confirming zero increased risk of breast cancer, heart attack, or stroke went almost entirely unheard by providers and patients. It documents the catastrophic consequences for the 16 million women who abruptly stopped hormones — including surging cognitive decline, hip fractures, sarcopenia, and overall mortality — while arguing for optimal lifelong hormone dosing, including for women over 65 who can safely begin treatment after cardiac clearance with Cleerly imaging or stress echocardiogram, supported by data showing HRT initiated within 10 years of menopause onset reduces heart attack risk by 50%, cognitive decline by 64%, and Alzheimer’s risk by 35%.

Top 5 Questions Answered:

• What did the WHI study actually show, and how was its data misrepresented by the media and missed by physicians?
• What health consequences did the 16 million women who stopped hormones after 2002 experience?
• Why does optimal lifelong hormone dosing outperform the “lowest dose for shortest time” approach?
• What cardiac evaluation process is required before safely treating women over 65 who have gone a decade without hormones?
• What does the FDA’s November 2025 removal of the estrogen black box warning mean for women and providers going forward?

For over 20 years, the health of women and the work of healthcare providers have been seriously compromised by a major medical misunderstanding.

The hurtful misunderstandings go like this: “if you’re going to use hormone replacement therapy (HRT), take the lowest possible dose for the shortest period of time. And whatever you do, stop at 65.”

This “rule” became common knowledge and practice after 2002. It shaped how millions of women were treated. Or more accurately, how they stopped being treated.

But here’s what most people don’t know: the science never supported this rule. Not in 2002. Not ever.

The Study That Changed Everything—Based on a Misreading or Mal-reporting

In 2002, the Women’s Health Initiative (WHI) study hit the news. Headlines shouted out that HRT caused breast cancer, heart attacks, and strokes.

Overnight, most of the 18 million American women in menopause being treated with hormones stopped their hormones. That number plummeted to less than 2 million.

When I heard the headline, I actually dove deep to read the details of the study. Not just the headlines. The actual data.

What I found was alarming.

The study itself never affirmed that there was increased risk of breast cancer, heart attack, and stroke! The press picked out one part of one comment, falsely represented it and exploded it into the world.

Here’s what the study actually showed:

Women taking Premarin alone (horse-derived estrogens, 50% of which have never been seen by a human female) had an actual reduction in breast cancer risk.

Women taking PremPro (Premarin plus a synthetic progestin) showed what the study called a “statistically insignificant increase” in breast cancer risk.

In science, “statistically insignificant” means you can draw no conclusion. The finding has no statistical weight.

But the media didn’t report it that way and most physicians did not pick up on this crucial nuance.

The Consequences Were Catastrophic

What happened to those 16 million women who stopped their hormones?

The losses were devastating:

• Cognitive decline and dementia increased
• Bone loss led to hip fractures and disability
• Muscle loss (sarcopenia) forced women into canes, walkers, and wheelchairs
• Vaginal atrophy caused genitourinary infections requiring adult diapers
• Overall mortality increased, as documented in scientific studies

For many women, stopping hormones eventually marked the transition from independent living to assisted care facilities.

This has been detailed in scientific studies showing increased deaths. But not many people were aware of or affected by these studies unless you were one of the healthcare providers who paid close attention to the facts re the WHI, and the follow-up studies, or were one of the women who suffered from the losses.

I Never Stopped Prescribing

Many of my colleagues and I had been prescribing compounded bioidentical hormones for 10 to 20 years before the WHI study came out.

We took the time to analyze the data carefully.

I was resting on the confidence of the great benefit to women and a whole host of studies that occurred over decades showing the benefits and safety of hormones. I did not drop a beat.

I continued treating women with bioidentical hormones while most of the medical world became frightened and adverse to prescribing hormones.

It turns out we were right.

The Retraction Almost Nobody Heard About

By 2006, the original WHI Study Committee made a crucial discovery.

The progestin arm (PremPro) now showed a reduction in relative risk of breast cancer to 1.0. That means no increased risk. Not even statistically insignificant.

Then in 2017, a dramatic but relatively unnoticed event took place.

The original WHI Study Committee published in the Journal of the American Medical Association—the same journal where the original study appeared—a complete retraction.

After 18 years of follow-up data, they stated clearly: there is no increased risk of breast cancer, heart attack, or stroke.

How many healthcare providers learned about this retraction?

In my experience, very few.

How many women around the world heard about it?

Very few.

The Market Told a Different and Interesting Story

By 2014, a medical study examined the status of hormone treatment in America.

The numbers had recovered somewhat. About 6 million women were back on hormones—one-third of the pre-2002 number.

But here’s the interesting part: over 50% of those 6 million women were using compounded bioidentical hormones.

Pharmaceutical manufacturers noticed. They weren’t happy about losing market share.

A campaign that has continued for decades, inappropriately critical of compounded bioidentical hormones and trying to make them unprescribable, has been one of the appalling actions of the way actual medicine can unfurl behind the scenes.

This wasn’t about best medicine. It was about competing financial interests determining what therapies patients could access.

The Black Box Warning That Scared Women… Until Ultra-Recently

Up until November of 2025, every prescription for estrogen came with a black box warning.

Here is what it used to say:

That taking these hormones increases your risk for breast cancer.

The warning is now gone. However it will take some time for the word to really spread to women and to healthcare providers that it is (and always was) safe to be treated with estrogens.

In November 2025, the FDA officially removed the black box warning from all estrogen-containing hormone therapy products after more than 20 years. FDA Commissioner Dr. Marty Makary called this black box warnings “one of the greatest mistakes in modern medicine.”

The Optimal Approach: Not Lowest Dose, Not Shortest Time

The “lowest dose for shortest time” mantra became standard after 2002.

I disagree completely.

The optimal treatment is optimal dosages, not too little and not too much, for your entire life. Not the lowest doses, and not to be discontinued.

What does optimal mean?

It means dosages that:

• Alleviate symptoms completely
• Restore function and richness to life
• Fall within testable, monitorable parameters of safety
• Dosages adequate to prevent bone loss and restore health to the vagina, while also falling shy of being excessive, which could provoke breast glandular cell proliferation and thus risk increased breast density, a known risk for breast cancer

This applies to almost every human being mid-life and beyond.

All you have to do is talk to any woman or man who’s been successfully treated with hormones. They’re not going to want to let go of those hormones.

Many people who stop hormones experience deleterious consequences. Then they return to treatment.

The body knows what it needs.

What About Women Over 65 Who’ve Never Been on Hormones?

The “65-and-out” rule had a companion: “never treat a woman after 65.”

I disagree with this, too.

When a patient comes to me, and she’s older than 65, and she has not been on hormones, and she has many of the symptoms and signs of depleted ovarian hormones, I do not shy away and turn this patient away.

These women often present with:

• Cognitive challenges that could even signal approaching dementia
• Probable osteoporosis
• Sarcopenia (muscle loss)

But there are specific risks to consider.

The Cardiovascular Consideration

Estrogen is protective to arteries. When a woman goes 10 years into menopause without hormonal treatment, she’s at increased risk for arteriosclerosis.

This can be problematic everywhere, including in the coronary arteries.

There’s a very rare risk: a woman with arteriosclerosis may have developed a clot (thrombus) in a coronary artery. The rough surface of an arteriosclerotic artery can provoke clot formation.

For one year—and oddly enough, one year only—when you treat these women with hormone replenishment (especially estrogen), there’s a risk that the thrombus could break loose as an embolus and cause a heart attack.

This is a very, very rare circumstance and I have never run into it. I have also surveyed some very experienced hormone providers about this.

But being medically conservative, my practice requires a cardiac evaluation for women over 65 who’ve been 10 years without hormones.

The Evaluation Process

The evaluation begins with a thorough medical history to identify hereditary risk factors.

It includes blood testing and can extend to sophisticated cardiac imaging.

The most advanced test available is called Cleerly—a rapid CT scan with additional AI interpretation of the images.

Less sophisticated but valuable options include the stress echocardiogram. If a woman has compromised coronary circulation, she’ll get short of breath or chest pain when stressed on a treadmill.

The goal is to get clearance from a cardiologist before starting treatment.

As everywhere, in every field of medicine, when a patient comes to me for whatever reason, I do what I always do. I take a thorough medical history, and that will point to various forms of imaging and testing that I want to do.

Then comes discussion with the patient. Risk-benefit analysis. Shared decision-making.

There are risks with things you do, there are risks of doing nothing. And I come up with an optimal program in consort with that patient, and we deploy it.

The Science Supports Treatment Beyond 65

The Menopause Society now advises that continuing HRT beyond age 65 is reasonable for healthy women with persistent symptoms.

Women who start HRT within 10 years of menopause onset experience significant benefits including a 50% reduction in heart attack risk, 64% reduction in cognitive decline, and 35% lower risk of Alzheimer’s.

Times Are Changing

Under new FDA leadership—specifically, Dr. Marty Makary—major changes are underway.

The black box warning that has terrified women for over 20 years is finally being removed.

This has caught the attention of many, and my hope is that the removal of this black box warning is going to relieve healthcare providers who prescribe hormones as well as women and those that love them.

What happens when providers feel safe to prescribe again?

They could be wonderfully deluged by women who want treatment.

Many providers will need to learn how to do this work properly. That education gap represents both a challenge and an opportunity.

This would be a sea change.

Traditional medicine is loosening restrictive criteria. More women are being treated. Guidelines are being updated.

The best-case scenario? More women will be carefully evaluated and excellently treated with hormone replenishment.

What This Means for You

If you’re a woman currently on HRT and approaching 65, you don’t have to stop.

If you’re over 65 and were told to discontinue hormones, you have options.

If you’re over 65 and never started hormones but are experiencing symptoms, you’re not too old for treatment.

The key is finding a provider who:

• Understands the actual science (not the 2002 headlines)
• Has been thoroughly trained, mentored, and knows how to work with bioidentical hormones
• Will do proper evaluation and monitoring
• Aims for optimal dosing, not minimal dosing
• Treats you as an individual, not an age category

The 65-and-out “rule” was never based on good science.

It was entirely made up, based on fear, misinterpretation, and institutional inertia.

That era is ending.

What comes next is a return to individualized medicine. To treating the patient in front of you based on their specific needs, risks, and benefits.

To giving women the facts and the choice.

After 20 years of unnecessary suffering, the tide has turned, and millions of women can, with free heart, be treated with hormones.