The Annals of Inconvenient Medicine

Research Under a Fauxtalitarian Regime

C. Everett Koop, the Surgeon General under President Ronald Reagan, was a controversial figure from the moment of his nomination. A pioneering pediatric surgeon, Koop was adamantly anti-abortion. Dr. Koop once said, “How could I ever accept the destruction of the unborn after a career devoted to the repair of imperfect newborns, knowing the joy and fulfillment they brought to their families?”

Koop became a favorite of the burgeoning “pro-life movement” in the late 1970s after a book and speaking tour in which he and theologian Francis Shaeffer argued that allowing abortion because a baby was “unwanted” would pave the moral ground for euthanasia of disabled or elderly people. (Oh, that slippery slope.) Evangelicals, who were just gaining political power, were pleased with his nomination for Surgeon General in 1981 because they did not think Reagan himself was committed enough to banning abortion.

The left, on other hand, felt that Koop was a dangerous and ideological choice. They also pointed out that even though he was a surgeon, he had no public health experience. (Oh, how our standards have fallen.) The New York Times ran an editorial headlined “Dr. Unqualified,” the American Public Health Association argued we’d be better off with no Surgeon General, and Senator Ted Kennedy said Koop held “cruel, outdated, and patronizing stereotypes of women.”

When he did take his post—after eight months of confirmation hearings—everybody was surprised. He didn’t touch the issue of abortion at all during Reagan’s first term later saying that he saw it as a moral issue that was outside the purview of his office. (Oh, for the days when.) He took on big tobacco and got warnings put on packages of cigarettes. Most importantly, he took a commonsense approach to the emerging HIV epidemic. Unlike others in the White House who were flippant and cruel and suggested quarantining gay men, Koop argued for confidential testing, condom use, and widespread education (including sex education starting in third grade).

Toward the end of his second term in office, Reagan dragged Koop into the abortion debate. He asked the Surgeon General to write a report about the psychological effects of abortion on women. Reagan was looking to throw a bone to the Far Right who thought he had not done enough to restrict abortion. Koop wrote in his autobiography that he was naïve at the time and didn’t understand that Reagan expected him to use this as an opportunity to vehemently oppose abortion. That’s not what happened.

He approached the report as a scientist. He interviewed experts and activists on both sides and read what little research there was on the topic. He came to believe that anti-choice groups deliberately distorted the science. After months of research, he concluded that there “… was no unbiased, rigorous scientific research on the effects of abortion on women’s health that could serve as the basis for a Surgeon General’s report on the issue.” He never wrote the report.

Many believe that this decision, along with his vocal actions on AIDS, is what prevented the George H.W. Bush Administration from appointing him Secretary of Health, a position which he wanted. (Oh, how good this would be right now.)

As of last Thursday we have a new Secretary of Health. He is not a man of science. He is not a man of integrity. He has said that he supports access to abortion up to the point of viability, but he also said that he wanted to work for Kamala Harris. Neither side of the abortion debate trusts him to be impartial or stick to his word.

In a move that seems to echo history, Trump has asked RFK, Jr. to study the safety of mifepristone. The President claims he has not yet decided whether to restrict access to the embattled abortion drug.

If RFK, Jr. were to put out an accurate report on the safety of mifepristone he would explain that there have been five deaths per million uses since it was approved 2000. That’s a death rate of 0.0005%. He might also say that mifepristone is safer than penicillin (20 deaths per million) and Viagra (49 deaths per million). And he’d note that mifepristone comes with 0.31% risk of complications compared to 0.41% risk with a procedural/surgical abortion and 1.3% risk with pregnancy/childbirth.

Somehow, I can’t see this being the report he writes. He’s not naïve. He knows exactly what is expected of him. Moreover, with his extreme and entirely unproven vaccine positions, he’s demonstrated himself eager to warp science to fit ideology.

This is likely the first of many examples of what happens to research under a fauxtalitarian regime. (Did I just coin a new word?) They’re cutting funding, limiting topics, and dictating language. It’s going to get a lot harder for researchers to conduct studies and for the rest of us to interpret them. And there’s another problem we have to worry about: what happens when legitimate research plays into ideological talking points in a way even the authors did not intend?

This week I offer two stories where good science makes for bad politics.

From the Mixed-Up Files of Mrs. Mirena E. Mifepristweiner

Contraception is under attack from the left and the right. On the one hand we have the wellness TikTokers would like us to believe that all hormonal methods of birth control—and most methods we have available today do have some hormones in them—are terrible for body and soul. On the other we have the masters of Project 2025 who are systematically trying to take us back to the days where women were barefoot, pregnant, and quiet. Each side has gotten an inadvertent gift recently in the form of legitimate research.

The first is retrospective study of Danish women who have used hormonal birth control methods published in the British Medical Journal. It has long been known that hormonal contraceptives can raise the increase of stroke or heart attack, especially in people with pre-existing conditions, those with higher BMIs, and those who smoke. This study put real world numbers to that increased risk for a variety of hormonal methods. (Remember this is an observational study, and as such it deals in correlation but can’t go as far as to prove causation.)

It found that use of combined oral contraceptive pill (the kinds that use estrogen and progestin) was associated with double the risk of ischemic stroke and myocardial infarction (aka heart attack). This sounds terrifying until you look at the real-world incidence of these complications. The increased risk translates to one extra stroke for every 4,760 women using the combined pill for one year and one extra heart attack for every 10,000 women per year of use. That’s not nothing, but it’s also not reason for every woman in America (or Denmark) to throw out their birth control pills.

This study also broke down risk by type of hormonal contraception with some interesting results. The vaginal ring, which contains estrogen and progestin, was associated with a higher increased risk of both heart attack and stroke than pills with the same two hormones. This is likely because of its direct and continual release of hormones. But the patch, which also continually releases both estrogen and progestin, was only associated with increased risk of stroke. The progestin-only pills increased risk of both (though less than the combined pill), but the implant and injection which also contain only progestin were only associated with higher risk of strokes. In fact, for these two methods the risk of heart attack was not calculated because there were so few events.

Perhaps the most important take-away from this study is that hormonal IUDs like Mirena or Skyla were not associated with any increased risk. The authors note that these cause the smallest increase in serum progestin levels which may explain why they don’t increase risk.

This is a good study that adds to our understanding of the risk of medication and devices that millions of people around the world use. It’s important, and it’s going to be reduced to alarmist headlines that make both wellness influencers and Comstock enthusiasts giddy. I fear that neither side will spread this information in a careful, nonbiased way that helps women who are trying not to get pregnant.

Which brings us to our second study which is also legitimate (it doesn’t get more legitimate than the New England Journal of Medicine), and plays right into the hands of those who are “this close” to getting rid of Mifepristone and chomping at the bit to go after emergency contraception.

This new study looked at 133 women who sought medication abortions in Mexico City. Instead of being given the standard regimen of mifepristone and misoprostol, these women were given a double dose of Ella and misoprostol. All but four of the women successfully terminated their pregnancy without any further intervention. That’s about a 97% effectiveness rate.

Ella is the prescription version of emergency contraception pills. Like Plan B and its generics, Ella is taken after unprotected sex to prevent pregnancy. Ella is a little more effective than the other formulations, can be taken up to five days after sex, and works for people over 165 pounds (which the others often do not). Like other ECPs, Ella works by preventing ovulation: if there’s no egg, it doesn’t matter that there are already some sperm in the area.

Unlike other ECPs, Ella doesn’t use hormones similar to those in birth control pills. Instead, it relies on ulipristal acetate which is a progesterone blocker. (Mifepristone is also a progesterone blocker.) Researchers have said it highly unlikely that Ella (especially in the dose prescribed for emergency contraception) acts after fertilization to prevent implantation. Nonetheless, some people continue to argue (possibly while twirling their evil mustaches) that Ella must be an abortifacient. Remember in the world of real science, pregnancy doesn’t start until the blastocyst is nestled nicely in the uterine lining, so even preventing implantation wouldn’t make it an abortion drug, but the mustache twirlers don’t care about that.

And this study seemingly reinforces their arguments even though it doesn’t add much to our understanding of anything. First of all, the women were given a dose of Ella that’s double what’s used for emergency contraception. More importantly, they likely would have successfully terminated their pregnancies without Ella because they were given misoprostol which induces miscarriage by opening the cervix and causing uterine contractions. Misoprostol alone can be 93% effective with multiple doses.

To be clear, this study does not show that using Ella and misoprostol together is any more effective than using misoprostol alone, and it doesn’t show that taking Ella by itself will affect an established pregnancy.

What it does do is add to the confusion about which pill is which and what does what, and that is only good news for the Project 2025 types who don’t want us to have access to any of them.

Winx Takes on Emergency Contraception Politics, Education, and Sales (Of Course)

If there’s any good news in women’s health right now, it’s that there are a lot of startups—often founded by young women—trying to ensure continued access to emergency contraception and other women’s health products. This week, I sat down with Jamie Norwood and Cynthia Plotch, the cofounders of Winx, which started selling pregnancy tests about six years ago. (The company was originally called Stix.)

I asked about their motivation for starting a new company, their decision to branch out into emergency contraception, and their blunt attitude toward politics.

SOW: Let’s start at the beginning. What are your backgrounds, and what prompted you to start Winx?

Jamie: Cynthia and I were co-workers at a small start-up when we were pretty much right out of college. We were like employees five and six. We worked there for few years and always talked about doing something ourselves. We liked the idea of being the ones in charge of hiring a team and building a product. We knew were passionate about women's health, but Cynthia had an especially bad experience buying a pregnancy test that prompted this idea. She can tell you about that.

Cynthia: I mean, the short version is that I was in the drug store buying a pregnancy test and ran into my boyfriend’s—now ex boyfriend’s—mom.

You had the pregnancy test in your hand?

Cynthia: Yeah, and I dropped it ran like the mature, grown adult I am.

Jamie: She called me, and I understood what she was saying about buying those kinds of products. My stories are not quite as dramatic as that, but I’ve had bad experiences buying, in my case, UTI products. We thought maybe this was where we should start working on a business.

I can imagine telling all my friends about the pregnancy test and the ex-boyfriend’s mom, but I’m not sure it would occur to me to then go out and start a new business. How do you make that leap?

Cynthia: We started by talking to people about their experiences so that we could understand if this was a universal thing, or a Cynthia and Jamie thing. We talked to people about their experiences buying and using these products and did some surveys. Then we got a little bit of funding to find a supplier and some product samples, and we just sort of chipped away nights and weekends at this project. We were lucky to get some amazing support early on and were able to raise some money for it.

Jamie: Also, we were at an early-stage startup when we met. We sort of had a blueprint and had seen people do a very similar thing for a different product. That really enabled us to dive in because we knew what we had to do first, second, and third.

No one wants to run into any potential mothers-in-law in Duane Reade, but what other problems were you trying to solve for?

Cynthia: In general, the biggest problem is confusion. The products are confusing to buy and confusing to use. If you’re in the women’s health aisle, nothing says UTI or yeast infection or even pregnancy test.

Starting from that first moment of the packaging, we make it incredibly clear to consumers exactly what the products will do. And that experience of simplification carries through the entire way. The product instructions are not written like a CVS receipt, right? They're clear and easy to use so real people with vaginas can understand them.

Also, we’re making a brand that represents the experience of all users. This is especially important with pregnancy tests. Most of what’s on the market assumes that you want to be pregnant. That’s great, but a lot of people who buy them don’t want to be pregnant. That’s great too.

You’ve branched out into other products. Can you tell us about your UTI test and vaginal health test?

Jamie: These are tests you can take at home. There’s a digital component that will check your symptoms, analyze your results, and connect you to a doctor for prescription treatment if you need it. It’s almost like making the antibiotics available over the counter but with the clinical evidence that you need it and the help of a provider. It’s definitely safer than going online and trying to order antibiotics on your own, and it’s easier and more affordable than going to urgent care.

How much is it?

Cynthia: Right now, there's a $15 fee for the telehealth appointment, so less than the cost of most copays. You can use your own prescription plan for the medication if you have one. We also let you price compare so people without insurance will know what Walgreens or CVS or their local pharmacy charges. Plus, these are usually basic antibiotics which are traditionally not very expensive.

When did you launch Restart, your emergency contraception pills, and why?

Jamie: We launched our emergency contraception in May of 2022 which was right before the Dobbs decision. That was on purpose. We knew that the Supreme Court was going to be voting on that case and how it was likely going to unfold. Obviously, we hoped for the best, but we knew that emergency contraception was an incredibly important product and about to be even more important.

We did a lot of research and found that there was—and still is—a ton of confusion around the morning after pill. A lot of people think it's the same as the abortion pill even thought it’s completely different products. EC has been one of our most popular products. Politically it’s our most important product, and it changed our trajectory as a business. We started with pregnancy tests and diagnostics tests, and now we're providing EC and a ton of education around reproductive health and reproductive justice. That’s definitely something we want to continue to do. For our big marketing campaigns, we’ve taken out billboards that simply say, “the morning after pill is still legal.”

Traditional packaged goods company’s often shy away from politics partly because in addition to selling women’s health products they’re selling kitty litter and soap. You guys seem to be embracing the politics behind your product. Was that a deliberate decision?

Jamie: It's kind of new for us. We did not talk about politics the first few years of our business, and then once we launched emergency contraception, it didn't even feel political anymore. It was just about women's health. Our products are political by nature. I mean, even pregnancy tests are, so we decided to speak up. Last year, we partnered with a creator who was at the DNC to do some events and pass out our emergency contraception pills. The response was just amazing.

We decided to lean into it. It's what we believe, and it’s what we feel is right. Our brand grew a lot from being politically outspoken. We always want to stay true to our roots and advocate for what's right while providing a product that everyone wants to use, no matter their beliefs, because a lot of people who don't believe in abortion rights and reproductive rights do use these products and need them.

Cynthia: It’s not that we ever saw ourselves as getting political. We just saw ourselves as protecting the community that we built. We never said pregnancy tests are a political product or emergency contraception is a political product, but women's bodies are a political pawn. That happened to all of us, and we just decided that we weren't going to stand for it.

Well said. We certainly are being used as pawns. What’s next for Winx?

Jamie: Right now, we’re focused on getting into drug stores and retailers. We want to make these products as accessible as possible and get them into the hands of everyone who needs them. We’ve always been digital first. If you're on Gopuff or DoorDash, great, but a lot of people don't use these apps. We want to be on shelf.

Thanks so much for talking with us and sharing your experience. Hopefully, we will find Winx products in the women’s health aisle someday soon. In the meantime, you can shop or read their blog at www.hellowinx.com.