Unexplainable - How medicine mansplained women’s health

Episode Date: December 8, 2021

Until 1993, many researchers excluded women from clinical drug trials, leaving doctors in the dark about how new treatments work in more than half the population. This is the story of why that happened, the women who fought to change it, and what we still don’t know about how sex and gender affect health. For more, go to http://vox.com/unexplainable It’s a great place to view show transcripts and read more about the topics on our show. Also, email us! [e-mail] We read every email. Support Unexplainable by making a financial contribution to Vox! bit.ly/givepodcasts Learn more about your ad choices. Visit podcastchoices.com/adchoices

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I'm Noah's Hassanfeld. A few months ago, a woman came into the ER at Dr. Alana Morris's hospital in Atlanta. This young woman experienced some shortness of breath and some chest discomfort She had just given birth to her third child, so the ER doctors assumed that was the issue. Probably just, you know, she stressed from being a new mom and go home and try to get some rest. So the patient went home. But the problem didn't go away. A few days later, she came back to the ER with the same issue, shortness of breath. And so the doctors examined her heart. She clearly had abnormal EKG and elevation of cardiac enzymes, and it was recognized that she was

having an acute event. Alana's a heart specialist, and it was only at this point that she got called in. Unfortunately, by that time, she had lost a lot of function in the wall of her heart. She ended up needing a heart transplant because of the delay in diagnosis. Often when you hear stories like this, the explanation comes down to bias. Women aren't taken seriously. They're ignored. And really, this can happen with anyone who's not a cis white,

male, like people of color, trans people, non-binary people. But it's not just bias. Reporter Jillian Weinberger spoke to Alana about this disparity, and she says in a lot of ways it actually comes down to training. When Alana was in medical school back about 20 years ago, she was taught that heart disease had a very specific presentation. There was a photograph in her medical textbook. An older white male, usually in his 60s to 70s, you know, usually balding.

It's basically a stock photo of a heart attack victim. His fist clenched over his chest with a grimace looking like he's in a lot of pain. That clenched fist is called the Levine sign. Sort of a classic sign that many of us learned during our training. We're often taught to recognize substernal chest pressure as the typical form of chest pain. But it's not typical for everyone. Women often have different symptoms. They're more likely to come in to the emergency room complaining of nausea or indigestion.

And maybe they're sent home with Maylocks and some tums. Or they may come in feeling short of breath and they might get a chest x-ray. Or they may come into the emergency room complaining of anxiety just sort of not feeling well. And again, they might be told that they are anxious and they need to see a psychiatrist. women in the U.S. die of heart disease almost as often as men do. But in medical school, Alana wasn't taught to look for women's symptoms. Until recently, a lot of doctors weren't. So women are often misdiagnosed and send home.

And unfortunately, by the time they do come back, they are well into the throes of an acute heart attack that might have been able to be treated more effectively, of course, had it been diagnosed earlier on. This case is an example of the case. of a much larger problem. There is a lot we don't know about how sex affects the way people

experience health issues. And it turns out there's a reason for that. There is a long history of researchers focusing on men and excluding everyone else. I wanted to know why that happened. Why, in many ways, we're still in the dark about more than half the population.

The story starts just after World War II. That's when the modern era of biomedical research began. This is a story of the United States Public Health Service. The NIH, the National Institutes of Health, started to expand, by a lot. Congress gave the NIH a lot of money for new grant programs,

and the agency opened up a new clinical research center. It became the largest public funder of biomedical research in the U.S. and in the entire world. In modern, well-equipped laboratories, NIH scientists are making important progress in many areas of research. At first, women were included in the NIH research, boom. But that started to change in the 1960s. Clinical research on women was pulled back by some reproductive health tragedies.

This is Susan Wood. Currently a research professor of health policy and management. And Susan told me about three tragedies in particular. The first was discovered in late 1961. Concern over the tragic effects of the new sedative thalidomide prompts President Kennedy at his press conference to call for stronger, better administered drug laws. Pregnant people were given thalidomide in Western Europe and Canada to help with insomnia and morning sickness, but it caused serious congenital disorders in thousands of babies.

The placenta was thought to be protective, and this was actually the first time where there was this widespread recognition that something you took by mouth would get across the placenta and cause extreme damage. The FDA never approved the drug in the U.S. It also scared the bejesus out of everybody. About a decade later, scientists discovered a similar disaster. The drug DES, diethylostobestrol, was given to prevent miscarriage, but it actually didn't. Researchers found out DES also crossed the placenta, and it caused cancer and other problems in the children of the people who took it. Around the same time, there was a third disaster, and had to do with a type of birth control IUD called the Dalcon Shield.

The Dalcon Shield was being a second. badly designed. It caused pelvic inflammatory disease, infertility, deaths. It was a disaster. So thalidomide, DES, and the Dalcon Shield. Those three things made the idea of doing research on new drugs and giving them to women who might become pregnant. Scary. And so NIH research started to change. A lot of researchers decided to leave women out of their clinical trials. Part of the motivation was protective. They didn't want to take any chances of hurting a pregnant person or their fetus. But this decision also made it easier to design research. When researchers put together a study, they'd try to limit the variables. You try to make your population sample as simple as possible.

Researchers thought female bodies were too complicated because of the way hormones changed throughout the month. They thought those pesky menstrual cycles would screw up their data. So you have young, white, male, people, in your studies because you don't have to deal with any complications of any kind, age, race, sex, anything. Even female animals got left out. To make life simpler, the rats were all male. Scientists would just take the data they collected on male rats or male rabbits or male humans

and assume the response would be the same in females. That's how NIH research worked for a long time. The people doing the research were typically men, and so were the subjects in their studies. But over time, that started to change. By the 1980s, second wave feminism had brought more women into powerful positions. There were more women in Congress, not a lot, but more. There were more women in media. There were more women scientists.

And the women scientists at the NIH started to speak out. I basically have had only two interests in life, sex and science. Everything else has been adapted so I could do those, including OBGYN. Dr. Florence Hazeltine was one of the very few OBGYNs at the NIH in the 1980s. She was trying to get the organization to invest more resources into her field, to hire more doctors like her. And I went to my boss and I said, we need more. And he said, yeah, of course we do. And then never did anything about it.

So Florence took charge. She decided she needed some outside help to convince Congress and the NIH that OBGYN deserved more attention. She teamed up with a public relations firm in D.C., and they brought together a bunch of women's groups to strategize. The first meeting was held at the American College of Obstetricians and Gynaecologists around the table that at that time was in the shape of a uterus. You're not going to believe it.

But anyway. Was it really in the shape of a uterus? Yeah. It may still be. I checked. The uterus conference table is no longer there. But back in 1989, around that uterus-shaped table, Florence and her co-conspirators got to talking, and they started to realize that the problem was bigger than OBGYN.

The NIH barely funded research on women, period. A glaring example of this problem came out that summer. The NIH funded a major study that found that taking a low-dose aspirin every day could help prevent heart disease. This isn't recommended today because we have better treatments, but at the time, this was huge news. There was just one problem. The study had only included men, 22,000 of them, and no women. I'd known about the studies. I knew the males weren't in it.

It was something that had pissed me. Florence and her colleagues realized that for real change to happen, they needed someone with political power, someone in Congress. I was at a meeting in Colorado, a veterinarian meeting, and I got up on the plane, and I had upgraded myself to first class. And Pat was sitting in, I think, 2A. Pat is Congresswoman Patricia Schroeder. Florence wanted to talk to her, so she switched seats with the guy in 2B. So we were flying back to Washington, and for three and a half hours she and I talked. When I told her that there were only three obstetrician gynaecologists in NIH, and I knew there were more vet, she said, well, how many are there?

I said, I'll find out for you. And I found out there were 39. The NIH had 39 veterinarians and only three OBGYNs. This didn't exactly surprise Congresswoman Schroeder. She was used to being outnumbered. When she joined the House, she was one of only 14 women. It was rather lonely, shall I say. And she wasn't happy about the aspirin study either. They hadn't had women in any of these studies.

So obviously we were a little upset about this. They teamed up with another congressman, Henry Waxman, and they started digging into the NIH's internal guidelines, where they made a discovery. Let me welcome you to our hearing this morning. Congressman Waxman held a whole hearing on this. Now, call on you for an oral presentation. Florence was actually there.

I'll never forget going to the hill. That was in June of 1990. It turned out that the NIH already had an internal guideline. Women had to be included in research. I'm pleased to be here today to discuss our review of the progress that NIH has made in implementing its policy to encourage the inclusion of women in study populations. The hearing was damning. Several problems have characterized NIH's implementation. First, it has been very slow.

And we were all sitting in the back, and I was later accused to smirking, which I probably was. The NIH wasn't following its own guidelines. And it wasn't just in the aspirin study. Women were being left out systematically. This was front-page news back then. Pre-internet, pre-all of that, right? This is 1990. That's Susan Wood again, the professor of health policy we heard from earlier.

Summer of the hearing, she was finishing up a postdoc. There's a little breakroom on the floor with all the laboratories where you go and have a couple of coffee or tea. And it'd always be like a Washington Post or Baltimore Sun or New York Times sitting on the common shared table, and so I was just sitting there reading the paper. And she saw that headline. The NIH was leaving women out.

At that moment, Susan recognized a central contradiction in her field. Scientists said that women were too complicated to study, but then they also said research done on men was applicable to women. It's an aha moment. I totally understand. You try to make your population sample as simple as possible so that you don't have complications to deal with. Totally understand that, totally get that.

But then the jump is, oh, then whatever you learn is generalizable to everybody. It's not even good scientific sense. Soon after her aha moment, Susan left the lab and went to work with Congresswoman Schroeder. The women in Congress felt that it was part of their job to look at women's issues that had been overlooked. They felt like they had to represent the whole country in some respects. They got to work writing legislation, a new law that required the NIH to include women in their clinical trials. But what they dreamed up did a lot more than that. The law also mandated that the NIH include racially diverse groups in those trials,

both because of biological differences in terms of ancestry and because of systemic racism. This new law made it easier for doctors and nurses to learn of certain treatments affected certain groups in different ways. It took a few years, but the bill was. was finally signed into law in 1993. We're here today for the signing of S-1, the National Institute of Health for the Organization Revitalization Act of 1993, and to especially recognize

the bipartisan coalition, which made this bill possible. Susan even got to go to the signing. They were kind enough to get us invited to the White House as well for this bill signing, very short notice. But hey, we were going. I'm particularly supportive of those provisions of S-1

aimed at improving the health of women and minorities. The law set a new standard for the $32 billion the NIH gives out each year. It forced researchers to either include women or justify why they weren't. And that changed the kind of questions researchers asked. I think it had a big impact on the types of things we do today. You know, the questions we're asking about COVID, the questions we're asking about long COVID, the questions we're asking about anything now is what's the difference between males and females?

What's the difference in their health outcome? the treatments, in the rehabilitation, in the whatever. NIH researchers in all kinds of fields are asking these questions. They're realizing how much we still don't know about sex differences in opioid addiction, in lung disease, and strokes. These questions make up an entirely new field studying differential impacts on women's health. But there are even more unknowns in terms of sexual orientation and gender diversity. There's a proposal in the House that could address these concerns.

It's called the LGBTQ Data Inclusion Act, and it would require the federal government to include gender and sexual orientation in surveys and clinical research. Ultimately, there is a lot of work left to be done, and the NIH only has so much control. The law didn't help that patient we heard about at the top of the show,

the one who got misdiagnosed in the ER. After all the research and strategizing and congressional hearings, the NIH is only one part of the problem. After the break, why the rest might be even harder to solve. It's all about you. And when you fly with Virgin Atlantic in their upper class cabin, they take the VIP treatment to the next level. With a private wing to check in and your own security channel at London Heathrow,

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Free of charge. BetMGM operates pursuant to an operating agreement with Eye Gaming, Ontario. At about 12 and a half, Mary reached puberty. Around this time, she found that her friends wanted to talk about... Unexplainable. It's unexplainable. We're back. Reporter Jillian Weinberger has been telling us about the push to include women in clinical trials.

It culminated in major legislation in the 1990s, and then it kind of fell short in the real world. Gillian takes it from here. The law did result in some changes, but NIH study design is just the first step in a long chain that funnels information from laboratories to doctor's offices. There are a lot of potential obstacles in that chain. Peer reviewers, medical journals, med school curriculum. It's necessary what the NIH is doing, but not sufficient. That's Dr. Stacey Geller. She's a professor of OBGYN, and she does her own research.

I had my son, who's a journalist, of course, check you out. He says, oh, she looks legit. Well, I'm so glad I passed the test. I wanted to talk to Stacey because she has done major studies on how the 1993 law has changed clinical research. Specifically, she looked at how the law affected what was getting published in scientific journals. These journals are how research gets from the laboratory to the doctors and nurses on the front lines of medicine. Researchers apply for a grant from the NIH, and they promise to include women in their studies.

Theoretically, the next step would be publishing those findings in journals. That's where doctors, nurses, and other providers would see the results. But here's what Stacey discovered. So basically what we found is that NIH policies have not resulted in any significant increases in reporting by sex and gender. Even though researchers are including more women in their studies, the vast majority still don't report on sex and gender difference. Take heart disease, for example.

Imagine a researcher studying a treatment. They have 2,000 participants in a trial. The researcher will collect all that data, but oftentimes they don't publish that data broken down by group. They'll say, here's how 2,000 people responded to the treatment. Not here's how men responded, here's how women responded, here's how non-binding, here's how non-binary people responded, and so on. Either researchers aren't submitting the broken down data for publication, or they are,

and the journals aren't accepting those papers. And this isn't just a problem in terms of sex and gender. Stacey also found that these journals often aren't reporting on data by race or ethnicity either, which means the information being collected because of the NIH law, it's not reaching the doctors, nurses, and other providers taking care of patients. And the NIH can't tell journals what to publish. So the onus of responsibility really needs to fall with the researchers themselves and with the journals that are publishing the papers.

Stacey has an idea about how to fix this. She pointed me to the journal submission process. Most of the Big Wig Scientific Journals have an advisory committee of experts in the field. That committee reviews the papers submitted for publication. They have a lot of say on what papers. get published. Stacey does this herself for a lot of journals, and she told me that when she's reviewing a paper... If it's relevant to the research, and they don't analyze by sex or gender, it's an automatic

reject for me. Huh. But not all reviewers feel that way, it sounds like... No. No. Why do you laugh? You know, I was on a call a couple weeks ago, and I said this, and it was a real epiphany for some people, they were like, wow, what a great idea. It would help if there were more reviewers like Stacey, gatekeepers who prioritized breaking down and analyzing data by sex, gender, race, and ethnicity.

That would get more of this information out to providers in the field, and into medical schools and nursing schools. It might have helped the patient we heard about at the top, the one who got misdiagnosed, sent home, and ended up needing a heart transplant. The information about women's symptoms was available. It just didn't make it to the providers in the ER. Alana Morris, the cardiologist who told us that story, she thinks change takes time, but it is happening. I know that the conversation has changed.

It is continuing to change. Medical education is becoming very open about diversity, about bias amongst clinicians. Diversity in medicine is so much bigger than sex and gender. It's race, class, neighborhood, age, sexual orientation. It means there are still a lot of unknowns we need to address in terms of how treatments might affect different groups differently. And absolutely, I hope that 10, 20, 30 years from now, the clinicians that we're training now will have a very different mindset towards how cardiovascular disease presents and manifests based on gender, based on race ethnicity, based on socioeconomic status, based on socioeconomic status, based on neighborhood, based on all of these different factors that we know impact differently.

Until that future, though, patients might have to advocate for themselves. That's what Patricia Schroeder has had to do. She's the former Congresswoman, the one who pushed for the 1993 law. She lives in central Florida now, and a few years ago, she had a health scare. I was driving a car on one of our busy interstates down here, and I thought, that is strange. She had some chest pain, nothing too intense, but from all the work she'd done on the 93 law, she remembered.

Women have particular heart attack symptoms. We don't have sharp pains like men. So when the mild pain came back a few days later, I thought, okay, this is it. I was savvy enough to get a hold of a cardiologist. I guess I was doing my own doctoring. He said, okay, go to the hospital now. Congresswoman Schroeder was having a heart attack.

She had to get a pacemaker put in. She recovered. She was lucky. But what about all the other patients? This episode was reported and produced by me, Jillian Weinberger. We had edits from Catherine Wells, Brian Resnick, Noam Hassenfeld, and Meredith Hodnott, who scored the episode with music from Noam.

Richard Seema did the fact-checking, Christian Ayala did the mixing and sound design, and the rest of the unexplainable team includes Mandy Nguin and Bird Pinkerton. Liz Kelly Nelson is the VP of Vox Audio. Special thanks to speak to Andrea Camp, Dr. Paula Johnson, Ruth Katz, Carolyn, Missouri, and Tim Westmoreland. If you want to get in touch, please email the team at UnexPlanable at Vox.com, and if you feel like leaving us nice rating or review, we'd really appreciate it. Unexplainable is part of the Vox Media Podcast Network, and we'll be back next week.