The M factor Documentary...the First Menopause Documentary to Lose Its CME Accreditation

And correcting basic WHI disinformation from the documentary...

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As readers of The Vajenda know, I first wrote about the M Factor documentary in October, after it came out, and also recently fact-checked a claim about tooth loss, with a disappointing (but expected) conclusion that a scary claim lacked the appropriate citation to back it up. I say expected because a lot of the documentary's medical content failed my fact check. I’m not discussing a situation where we have two conflicting studies and a genuine disagreement among experts; I’m talking about factually incorrect “Menopause 101” basic content or statements that contradict global consensus statements from multiple menopause societies.

Let’s be clear: a documentary is not medical education or necessarily even factual at all. However, when the people behind the documentary decide to make a big deal about getting accreditation for continuing medical education or CME credits and then use that accreditation as part of their marketing promotion, they are responsible for raising their own bar when it comes to accuracy. When a program gets CME credits, that means the information presented should be supported by the evidence, and off-label use of medications and financial conflicts of interest disclosed up front. This did not happen. In addition, one of the producers, Denise Pines, holds a leadership position at the Federation of State Medical Boards (FSMB) and owns a menopause tea company, and, in my opinion, that potential conflict of interest should also have been mentioned.

Also, what’s up with allowing someone who runs a supplement company to have a leadership position at the FSMB, an organization that, according to its website, is concerned with “the public’s health, safety, and welfare.” Isn’t that a bit like having a fox in the hen house. What’s next, bringing a member of the Sackler family (of OxyContin infamy) on board?

It turns out I wasn’t the only one disappointed with the documentary and its CME accreditation. On November 8, 2024, 16 experts from PharmedOUT.org, including doctors, pharmacists, and researchers, wrote to the Federation of State Medical Boards (FSMB), which provided the CME accreditation. Here is an excerpt from their letter:

We are researchers, clinicians, and women’s health experts who are writing to express deep concern over an activity on menopause that FSMB accredited based on viewing The M Factor: Shredding the Silence on Menopause (2024). This documentary film makes numerous unsupported claims, including recommendations for off-label uses of menopausal hormone therapy (MHT) that are unsupported by evidence, and is rife with misinformation, including statements that directly contradict warnings in FDA-approved product labeling. A major concern is that this film could lead to unsafe and ineffective prescribing.

The letter goes on to detail numerous inaccuracies, many of which I have already covered. The group asked the FSMB to not only halt further CME credit from the documentary but also to decertify it:

We request that FSMB’s CME accreditation for The M Factor be retracted, that the activity be removed from the FSMB website, and that anyone who has taken the CME should be informed that the activity has been found substandard and that any CME credits associated with the module will be revoked.

The letter from PharmedOUT.org was covered by Ed Silverman for STAT on November 21, 2024, who also mentioned my take on the documentary.

After recently hearing about the letter from PharmedOUT.org, I reached out to the FSMB with my concerns about the content, the conflict of interest with Denise Pines, and the appropriateness of giving CME credit to a program that provided a non evidence based view of supplements, especially considering Dr. Haver’s supplements were on her desk and in view, albeit turned around so the label wasn’t visible. I mean, Holy Conflicts of Interest, Batman.

Joe Knickrehm from the FSMB replied to my email as follows:

We removed the documentary from our website on November 21 and stopped offering CME that day. We have no plans to remove CME credit from individuals who completed the learning activity in good faith. We will be taking no further action.

I’m guessing the FSMB did not miss the write-up in STAT on November 21.

It’s disappointing that it appears to have taken public attention for get any action. It’s also unacceptable that they have not notified people who took the CME of the concerns with the documentary. I understand not revoking credit that was done in good faith, but sending a correction about the errors to those who obtained the credit would have been appropriate. You know, that is if “the public’s health, safety, and welfare” matters.

Unfortunately, Mr. Knickrehm from the FSMB did not answer my question about Denise Pines, which I felt was extremely salient as the the documentary presents a non evidenced based view of supplements, or about the appropriateness of even considering content about supplements for CME.

Speaking of fact-checking…

The WHI Did Not Primarily Enroll Women with Established Cardiovascular Disease.

When I did my film review, I didn’t cover every piece of disinformation. At some point, I felt my debunking was just running too long. But one error that was brought up by the PharmedOUT.org in their letter to the FSMB is worth discussing because I hear it a lot, and I bet you do as well. It’s a quote about the Women’s Health Initiative (WHI):

More than two thirds of the women already had established cardiovascular disease.

This statement is false. It’s so false, I just can’t even.

The first clue that this is simply wrong is in the title of the first paper from the WHI, “Risks and Benefits of Estrogen Plus Progestin in Healthy Post Menopausal Women”

If they were healthy, how did two-thirds have established cardiovascular disease?

I mean…

The WHI enrolled women who were representative of the general population, meaning the type of women who might be prescribed hormone therapy for primary prevention of heart disease. After all, the hormone arm was about primary prevention of coronary heart disease. If women had established cardiovascular disease, the study would be about secondary prevention. This is from the WHI study design:

“The hormone replacement therapy (HRT) component is a randomized, double-blind comparison among 27,500 women, with coronary heart disease as the primary outcome, with hip and other bone fractures as secondary outcomes, and with breast cancer as a potential adverse outcome.”

Note that it states coronary heart disease, which is a type of cardiovascular disease, as the primary outcome.

If you look at the baseline characteristics of women enrolled in the WHI, they are reflective of the general population. For example, about 36% were being treated for high blood pressure, 4.4% for diabetes, and 13% for elevated lipids. Having high blood pressure or being treated for it, or taking a medication for elevated lipids, or having diabetes isn’t the same as having cardiovascular disease. These are risk factors.

In fact, people take medication for high blood pressure or elevated lipids to prevent cardiovascular disease. Now, people with high blood pressure or high lipids can also have cardiovascular disease, but, thanks to science, lots of them don’t.

Cardiovascular disease means having previously had a heart attack or needing bypass surgery or a stent for a blocked artery. It can also mean having heart failure, congenital heart disease, valve disease, a stroke, peripheral arterial disease, or a blood clot in the legs and lungs. Let’s look at the numbers of women with established cardiovascular disease in the WHI:

• 1.6-1.9% had a previous history of a heart attack.

• 1.1-1.5% previously had bypass surgery or a stent for coronary artery disease

• 2.8-2.9% had a history of angina

• 0.7-1% had a history of a stroke

• 0.8-0.9% had a history of a blood clot in the legs or lungs

So yeah, not two-thirds, not by a long shot.

I have no idea where the claim that the majority of women had established cardiovascular disease comes from. My best guess is that someone confused cardiovascular risk factors for cardiovascular disease and then people just keep perpetuating the myth, because shitting on the WHI and cherry picking the parts that work for a specific narrative seems to be a social media strategy. Regardless of the origin, this false claim about cardiovascular disease is super irritating because the M Factor documentary claims that there was incorrect information put out about the WHI, and yet here they are putting out false information about the WHI.

Sigh.

Remember going forward that it’s rare to have non fiction shows or movies commit to fact checking medical content. Outrageous claims get far more attention. There were plenty of facts that the filmmakers could have used and I can only imagine the great content from Dr. Stephanie Faubion and Dr. Wen Shen that didn’t make the final cut. But choices were made.

And choices have consequences.

“The M Factor: Shredding the Silence on Menopause” documentary may have been the first menopause documentary to get CME accreditation, but The M Factor is also the first documentary on menopause to be stripped of its CME accreditation.

References

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

Design of the Women's Health Initiative clinical trial and observational study. The Women's Health Initiative Study Group. Control Clin Trials. 1998 Feb;19(1):61-109. doi: 10.1016/s0197-2456(97)00078-0. PMID: 9492970.