The WHI is Ending–You Should Be Furious and Concerned

Ignorance is Strength: RFK Jr and Trump's Anti-Science Agenda

It was shocking, but not unexpected.

The Trump Administration plans to gut the Women’s Health Initiative (WHI), because limiting our knowledge about preventing cardiovascular disease, dementia, colon cancer, breast cancer and bone health for women as they age is definitely a big step in making America healthy again!

Here is the announcement from the WHI:

WHI Funding Announcement (April 21, 2025)

Today, Women’s Health Initiative (WHI) investigators were informed that the Department of Health and Human Services (HHS) will terminate WHI Regional Center (RC) contracts at the end of their current fiscal year (September 2025). The WHI Clinical Coordinating Center (CCC) will continue operations until January 2026, after which time its funding remains uncertain. While written notification has yet to be received, investigators have been advised to expect formal confirmation soon.

The four regional centers slated to lose their funding this year are the University at Buffalo, Wake Forest University, Ohio State University, and Stanford University.

What is the annual federal funding for the WHI? It must be a lot to merit cutting it, right?

About $10 million.

A single trip for Trump to go to Mar-A-Lago costs the taxpayer just over $3 million, and mega-billionaires, who you would expect to have tax bills in the tens to hundreds of millions of dollars per year, often get away with paying no taxes. Here’s an idea: let’s fund science with the taxes that the billionaires should be paying! I felt a significant moral injury paying my taxes this year, considering how many billionaires often don’t pay any at all, or they get away with a 3% rate, or something insulting. While I am happy to pay for roads and schools and Medicare, I am not happy to pay for super-villain RFK Jr’s salary as he causes generational harm to the health of Americans and destroys scientific progress that benefits the world. I am also furious about paying ICE to snatch people off the streets and detain and deport them illegally.

But, I digress.

Decimating Data, Dismantling Health

The stupidity and cruelty is actually painful, because this move will decimate the most extensive study of women in the history of the United States. A study which had over 160,000 participants across multiple arms, and is still following (or at least until the funding runs out) 42,000 women. A study whose purpose was, in part, to compensate for the significant amount of medical research that has been overlooked for women.

The end of the WHI is not surprising given the word women is apparently part of a “woke” agenda. This rage against “woke” also explains the loss of programs that focus on contraception, track maternal mortality, the lab that tests for resistant sexually transmitted infections at the CDC, and programs to prevent transmission of HIV to name but a few. But the devastation really hits every organ system and physiologic process because programs to prevent the spread of tuberculosis, develop new therapies for pancreatic cancer, and a massive 30-year, nationwide study to help us understand the development of diabetes have been gutted (to name but a few). In addition, there are concerns about the data that is collected being suppressed or even altered. For example, Dr. Peter Marks, resigned as Director of the Center for Biologics Evaluation and Research at the FDA over concerns about “truth and transparency” not being desired by RFK Jr, but rather “he wishes subservient confirmation of his misinformation and lies” and Dr. Kevin Hall, one of the world’s most respected researchers in nutrition and metabolism, recently resigned from the NIH over what also sounds like a truth and transparency issue–censorship and having a press released about a new study altered by the NIH to make it sound like the data was more in line with RFK Jr’s unscientific beliefs.

I feel Dr. Marks has described what is going on the most succinctly, “subservient confirmation.” There is a combination of an egregious lack of understanding and/or willful disregard of the scientific process and a desire to disinform to serve RFK Jr’s lucrative anti-science agenda as well as enforce Project 2025. When people are sick or they are afraid to get health care it’s much harder to speak up and resist. Shiny objects, like food dyes, or the insulting and frightening “solving the autism epidemic” are held up as false tokens of effort for social media, the press, and the MAHA acolytes.

Knowledge is a threat to power, so we are witnessing Orwell’s “Ignorance is Strength” in real time. And what better way to destroy knowledge than by giving RFK Jr, Dr. Jay Bhattacharya, and Dr. Marty Makary the keys to the proverbial castle. It’s akin to putting three rabid raccoons into a Costco; eventually they’ll rip everything apart.

What We Stand to Lose

The WHI was a prevention study, specifically looking at strategies for postmenopausal women to reduce the risk of heart disease, breast and colon cancer, and hip fractures. The study had an observational arm that followed women for a variety of health outcomes and three clinical trials:

• Hormone therapy vs placebo: 27,347 women

• Low-fat diet vs standard diet, 48,835 women

• Calcium and vitamin D supplementation vs. placebo, 36,282 women

(Some women could participant in more than one arm).

Three extension studies have been conducted since the end of the original trial to provide longer follow-up and better characterize the effects of aging on women, as well as to understand the implications of medication, dietary, and supplement interventions. We now have twenty-year follow-up data, which is practically unheard of in this field. Additionally, 342 ancillary studies have utilized data from the WHI and at least 2,475 papers have been published. Data from the WHI have become part of other studies, such as WHISH, which examines the impact of physical activity on the risk of heart disease and stroke in older women.

I know the WHI gets a bad rap, and like every trial it is not perfect, but if you have heard it called a “bad study” or a “tragedy perpetrated on women,” you’ve been misled. Something that irritates me to no end are influencers who cherry-pick from the WHI, for example, claiming the hormone therapy-breast cancer data or the findings on cardiovascular disease are unreliable, but then they turn around and in their next post use the data on hormone therapy on bone health. The study design of the hormone therapy arm cannot be both terribly flawed and incredibly useful at the same time.

One criticism of the hormone therapy arm is that all of the women were post menopausal, but any doctor or health care practitioner making that claim has not invested any time in understanding the study. The women were post menopausal so that the study could be double-blinded. People couldn’t be menstruating, as hormones can affect periods, and they needed to be past the peak of hot flashes, as estrogen is effective therapy, otherwise it would be easy for the participants to know who was taking hormones and who was not, essentially unblinding of the participants. I suspect many who shit on the WHI have only come to be interested in menopause in the past few years and so don’t understand the menopause landscape before the study. Those of us who have been helping women in menopause for decades know that pre-WHI, there were doctors prescribing estrogen to protect the heart for women in their 60s and 70s and even older, and part of the impetus for the WHI was to determine if this was a valid therapy (it was not).

It is important to emphasize that the WHI was never designed to evaluate symptoms, nor should it have been used to tell women that hormone therapy was unsafe for treatment of symptoms. But there was nothing fundamentally wrong with the study or the information that came from it and the participants absolutely reflected what we consider to be a generally healthy population. The issue was with how the press reported on it and how some people interpreted the results, and today, the issue is also how some influencers misconstrue its results for their own profit.

What We Have Gained from the WHI

First, that women are deserving of the investment of large scale clinical trials. Once the WHI got started, it provided a kick to get other studies rolling. There is always one study that gets the ball rolling, which then shows other scientists and those who fund studies that yes, this is an important topic. Having this much attention and money from the NIH told the scientific community that menopause is important.

I have recently utilized papers from the WHI to evaluate the impact of early menopause on muscle mass, as well as to assess the claim that nearly 30% of women experience tooth loss within the first five years of menopause. But the reach of the WHI goes far beyond that. Here is a summary of just a few of the important findings from the WHI:

• Showed that Premarin by itself reduces the risk of breast cancer that persists even after the medication is stopped.

• Demonstrated how Premarin plus medroxyprogesterone acetate is associated with an increased risk of breast cancer (6/10,000 women per year) that persists even after the medication is stopped. By year 20, there was no overall increase in risk of breast cancer mortality.

• Introduced the concept of a critical window theory of opportunity for starting MHT, meaning there are brain and cardiovascular risks when the medication is started years after menopause that don’t appear when it is started closer to the last period (this is still debated, but it shows how studies can introduce previously unknown threads to pull).

• Showed how a low-fat diet with an increased intake of vegetables, fruit, and grains reduces the risk of death from breast cancer in postmenopausal women.

• Established the association between alcohol use and hormone receptor-positive breast cancer.

• Demonstrated that long-term exposure to fine particulate air pollution increases the risk of cardiovascular disease and death.

• Showed there is no net benefit from either hormone regimen for reducing colon cancer.

• Set in motion the need to evaluate transdermal estrogen as a safer option from a blood clot perspective.

• Demonstrated that calcium and vitamin D do not reduce the risk of hip fractures.

Who is Standing up for the WHI?

I’m interested to see who stands up for the WHI and who does not. Any American who considers themself a menopause influencer who is quiet on this subject, in my opinion, is not someone invested in science or menopause. I suspect there will even be some who cheer the loss of the WHI, or use this tragedy as as a tool to promote their own particular menopause gold rush.

Where Do We Go From Here?

Ongoing data collection from the current 42,000 participants and research on the existing data are clearly at risk. This will likely mean that we will not capture data on women as they enter their 80s and beyond, thereby depriving women of a comprehensive, long-term review of their health over time. And of course, who knows the fate of all the ancillary studies that depend on this data?

Might there be a funding reprieve? Call your lawmakers and complain. Or if any of you have a connection to Melinda French Gates or MacKenzie Scott, let them know they could make a significant difference for only $10 million a year.

With the loss of the WHI, we can expect less interest in menopause. I know the banned “woke” words from the Trump administration make it very hard to write a grant that would even be entertained, but the end of the WHI feels like a menopause-research death knell.

Right now, things look grim for the WHI, for women and those of us who care for them, and for science in general. The very scientific-method is under fire, and the harm is incalculable. And right now I am really worried that the NIH-funded SWAN, the Study of Women’s Health Across the Nation, which not only studies women as they move from the menopause transition through menopause, and specifically looks at racial and ethnic differences, could be next.

References

1. WHI Funding Announcement https://www.whi.org/md/news/whi-funding-announcement

2. Manson JE, Crandall CJ, Rossouw JE, et al. The Women’s Health Initiative Randomized Trials and Clinical Practice: A Review. JAMA. Published online May 01, 2024. doi:10.1001/jama.2024.6542

3. Chlebowski RT, Aragaki AK, Anderson GL, Pan K, Neuhouser ML, Manson JE, Thomson CA, Mossavar-Rahmani Y, Lane DS, Johnson KC, Wactawski-Wende J, Snetselaar L, Rohan TE, Luo J, Barac A, Prentice RL; Women’s Health Initiative. Dietary Modification and Breast Cancer Mortality: Long-Term Follow-Up of the Women's Health Initiative Randomized Trial. J Clin Oncol. 2020 May 1;38(13):1419-1428. doi: 10.1200/JCO.19.00435. Epub 2020 Feb 7. PMID: 32031879; PMCID: PMC7193750.

4. Li CI, Chlebowski RT, Freiberg M, Johnson KC, Kuller L, Lane D, Lessin L, O'Sullivan MJ, Wactawski-Wende J, Yasmeen S, Prentice R. Alcohol consumption and risk of postmenopausal breast cancer by subtype: the women's health initiative observational study. J Natl Cancer Inst. 2010 Sep 22;102(18):1422-31. doi: 10.1093/jnci/djq316. Epub 2010 Aug 23. PMID: 20733117; PMCID: PMC2943525.

5. Kristin A. Miller, M.S., David S. Siscovick, M.D., M.P.H., Lianne Sheppard, Ph.D et al. NEJM;356: 447-458

6. Manson JE, Chlebowski RT, Stefanick ML, et al. Menopausal hormone therapy and health outcomes during the intervention and extended poststopping phases of the Women's Health Initiative randomized trials. JAMA. 2013 Oct 2;310(13):1353-68. doi: 10.1001/jama.2013.278040. PMID: 24084921; PMCID: PMC3963523

7. Chlebowski RT, Anderson GL, Aragaki AK, et al. Association of Menopausal Hormone Therapy With Breast Cancer Incidence and Mortality During Long-term Follow-up of the Women's Health Initiative Randomized Clinical Trials. JAMA. 2020 Jul 28;324(4):369-380. doi: 10.1001/jama.2020.9482. PMID: 32721007; PMCID: PMC7388026.

8. Chlebowski R, Aragaki AK. The Women's Health Initiative randomized trials of menopausal hormone therapy and breast cancer: findings in context. Menopause 30(4):p 454-461, April 2023. | DOI: 10.1097/GME.0000000000002154

9. Writing Group for the Women's Health Initiative Investigators. Risks and Benefits of Estrogen Plus Progestin in Healthy Postmenopausal Women: Principal Results From the Women's Health Initiative Randomized Controlled Trial. JAMA. 2002;288(3):321–333. doi:10.1001/jama.288.3.321

10. Prentice RL, Aragaki AK, Chlebowski RT, et al. Randomized Trial Evaluation of the Benefits and Risks of Menopausal Hormone Therapy Among Women 50-59 Years of Age. Am J Epidemiol. 2021 Feb 1;190(3):365-375. doi: 10.1093/aje/kwaa210. PMID: 33025002; PMCID: PMC8086238.

11. Thomson CA, Aragaki AK, Prentice RL, Stefanick ML, Manson JE, Wactawski-Wende J, Watts NB, Van Horn L, Shikany JM, Rohan TE, Lane DS, Wild RA, Robles-Morales R, Shadyab AH, Saquib N, Cauley J. Long-Term Effect of Randomization to Calcium and Vitamin D Supplementation on Health in Older Women : Postintervention Follow-up of a Randomized Clinical Trial. Ann Intern Med. 2024 Apr;177(4):428-438. doi: 10.7326/M23-2598. Epub 2024 Mar 12. Erratum in: Ann Intern Med. 2024 Sep;177(9):1295. doi: 10.7326/ANNALS-24-01296. Erratum in: Ann Intern Med. 2024 Sep;177(9):1294-1295. doi: 10.7326/ANNALS-24-01431. PMID: 38467003.