“I was told to control for every variable in my experiment, so I controlled for sex,” says Kibbe, now editor-in-chief of JAMA Surgery and dean of University of Virginia’s School of Medicine. She worked with her colleague, the oncology researcher Teresa Woodruff, to get a $25,000 grant to study the same promising cardiovascular treatment in female rats. Kibbe was shocked by the results: The average female needed much higher doses than her male rats to get the same clinical benefit.

This was back in 2011. More than a decade later, male animals and cells remain the dominant source of study in preclinical research, despite a 2016 mandate from the National Institutes of Health to include sex as a biological variable in both animal and human studies. There are also continued gaps in what we know about women’s health. The number of studies on women’s health still lags behind those on men in most research areas, and exceeds it only in reproductive health. Women remain less likely to be included in clinical trials—they make up only 41 percent of total clinical trial participants, according to a 2022 meta-analysis, which found even fewer female subjects in early-stage clinical trials, designed to test experimental therapies for safety and evaluate potential doses. (The analysis looked at studies conducted between 2016 and 2019; comprehensive data from more recent years is not readily available.)

Kibbe and a team of researchers this year sampled the literature regarding clinical studies in her field of vascular surgery. “It was kind of depressing,” she says. While the number of women in studies has improved over the years, they found less than five percent used any sort of sex-based analysis of disparities. Kibbe’s disappointment extends beyond her own field. Nearly a decade after the NIH policy was established, “we still have the practice of studying mostly male cells, mostly male animals.”

The unequal representation of women in trials means that “ultimately, we have this much bigger risk of not having good data about the safety of pharmaceuticals” for women patients and consumers, says Jill Fisher, professor of social medicine at the University of North Carolina, Chapel Hill. Fisher studies the experiences of subjects and researchers in Phase I trials, where safe dosing limits for later trials are established. Because men are on average larger and have different fat and hormone levels, trial phases with only men may skew the safe dosage results for women.   

Historically, the most serious adverse effects of commercially available drugs have disproportionately impacted women. Legislation in the 1990s loosened restrictions on female trial participation, which brought a new era of women’s health research, but a U.S. Government Accountability Office analysis of ten drugs withdrawn from the market in 2001 found eight of them caused greater adverse reactions for women. A 2020 study found low female participation rates were still leading to the overmedication of women.

These adverse reactions are not easily prevented by adjusting dosing to the smaller average body size of females. A 2022 study found complex reasons behind different drug reactions related to sex beyond weight—including hormones, fat distribution, and immune response. Some medications, such as propofol, may actually require higher doses in females.

The inequities in data persists despite decades of efforts by federal officials to spur more research into women’s health. Last week, the White House hosted its first-ever conference on women’s health care, the culmination of more than a year of focus by the administration through its White House Initiative on Women’s Health Research. The initiative, led by First Lady Jill Biden, worked with various agencies to put hundreds of millions of dollars into the issue, with an emphasis on midlife health (when women disproportionately experience disability compared to men):

• $110 million for technology innovations to be awarded in 2025 through the NIH’s Advanced Research Projects Agency for Health, or ARPA-H;
• $27.5 million initiative from the Substance Abuse and Mental Health Services Agency;
• $500 million from the Department of Defense, announced in September as an annual commitment to research issues that disproportionately affect women, such as Alzheimer’s, rheumatoid arthritis, lupus, and certain musculoskeletal issues. In addition, the DOD and the Veterans Administration established a Military Women’s Health Research Program, aimed at improving care for the more than 200,000 women in active service and the roughly 2 million women veterans.
• $200 million from the NIH toward the groundwork of an interdisciplinary fund for women’s health research.   

The government is focusing on health issues that, in addition to disproportionately affecting women, have long been relatively void of data. Eighty percent of people diagnosed with an autoimmune disease are women, for instance, but only in the last decade have researchers such as Arizona State University’s Melissa Wilson, a chromosomal biologist, started examining whether these diseases might have an evolutionary connection to pregnancy. Her work, she says, gives us a blueprint for how sex differences may influence disease.

“If we understand the root causes, then we can treat them,” Wilson says. Her study–which hypothesizes that the female immune system is amplified to protect against the drain of pregnancy–has sparked creative approaches to diseases like multiple sclerosis, for which scientists are investigating a treatment that mimics a hormone produced during pregnancy.

New funding and approaches still face substantial social hurdles: research into women’s health issues is often guided by assumptions that hormones make females behave less consistently and that the potential for pregnancy requires extreme oversight of women in trials. Fisher at the University of North Carolina has documented that female trial participants have been subjected to barriers not required of male participants, such as being required to stay at a research facility overnight to make sure they could not have sex and get pregnant. Men’s sperm also could be affected by the medications being tested, but where the women were taken off birth control and given daily pregnancy tests, the men were simply trusted not to have sex. At least two of 47 women Fisher interviewed chose to undergo permanent sterilization to be able to participate in clinical trials more easily.    

Mice and men

The use of male animals at the preclinical stage, before treatments are studied on humans, is rooted in a belief that a female mouse’s estrous cycle—the four-day mouse version of a monthlong human menstrual cycle—causes too much variation in the data, particularly data about behavior. Use of male animals remain the norm despite numerous studies, such as a seminal 2014 study by Brian Prendergast, Kenneth Onishi and Irving Zucker, concluding that estrous cycles create no greater variability in female rat behavior than the variability displayed by male rates.

In fact, in some cases, says Bob Datta, a neuroscientist at Harvard University, “the science would have been cleaner had you just used females.” Datta’s lab developed MoSeq, a motion sequencing detection model for observing mice. The AI model unveils the underlying structure of body language, revealing thousands more (and more subtle) data points, exponentially more than any human could see. Datta and his colleagues found that the males displayed twice as much behavioral variability as the females. He now uses female mice for his smaller studies with only one sex. “Not only was our folk wisdom wrong, but we were making the wrong choice,” he says.

Datta’s work builds on a 2022 meta-analysis of 263 rodent studies, which concluded outright that female rat behavior was not more variable than that of males. There is less research about nonbehavioral variables like temperature or heart rate. Early findings by scientists studying those variables, like Annaliese Beery and Arthur Arnold, have been similar to those in neuroscience.

The Biden administration hopes technology innovation will accelerate closing the research gap in women’s health. ARPA-H, which received over 1,700 applications for its $110 million in grant money, in October announced awards for 23 recipients. Work funded includes developing an ovarian cancer treatment using nanoparticles and a person’s own immune system; building an endometriosis blood test; and developing an at-home medication to mitigate the risks of pre-term labor.

Change can’t come soon enough for Melissa Wilson at Arizona State, who says it can seem like “we’re just blindly feeling out there” when it comes to some of the health conditions that affect women. Scientists do have some data to draw on for tests. But, she says, “we could do better.”

The post Of mice and women appeared first on Harvard Public Health Magazine.

That day, she says, she only noticed the stain as she arrived at the senate. She went inside the chamber anyway to draw attention to her cause: The lack of menstrual pads coupled with period shame is a reality faced by millions of girls and women in Kenya. But the first-term senator was ruled out of order by fellow legislators and castigated for violating the chamber’s dress code.

Even before this, Orwoba had been fighting against stigma—and “period poverty” more generally—through public service. In particular, she’d negotiated with government leaders to reduce corporate taxes that drive up the cost of sanitary pads. It’s one of the causes that paved her way to senate, where she holds one of the seats reserved for women’s affairs. Gender is the lens she brings to most of the bills she sponsors, and she works with peers in Uganda and Ghana on menstrual hygiene issues.

Orwoba sat down with Harvard Public Health contributor Lenny Rashid Ruvaga in Nairobi, Kenya to discuss three of her big ideas about periods. This interview has been condensed and edited.

Harvard Public Health: Recently, Parliament passed the Sanitary Towels Provision Bill you sponsored, ensuring an impressive funding increase for menstrual pads in public institutions, including schools and prisons. After a threat from the legislature to halve the budget for pads, you managed to get Parliament to double it, to 940 million Kenyan shillings (about $7.3 million). How did you do it?

Orwoba: You know, at the beginning of my advocacy, I was not so familiar with dealing with opposition. It really used to bring me down. For me, the most difficult moment was that the people that you are fighting for [sometimes say] that it’s not really an important [issue]: “Why are we talking about this?”

Now this is the beauty of moving from the civil society space into the public service space and into politics. From the civil society space, you are limited to public participation, demonstrations. You are outside. As a politician, you’re suddenly sitting in State House with the president, saying, “Mr. President, we are bleeding too much, and [the current budget] is not gonna cut it. We need one billion.” And, you know, those conversations for me are the highlight: This is what you can do with this position, as a woman in power. And I was so excited when those conversations behind the scenes materialized into [effectively] tripling the national budget allocation for pads. And now we have more girls receiving the free sanitary towels in schools.

HPH: You were an activist before you were a politician, and movement activism is often about working together. In your experience, do women parliamentarians also work together in the fight for more sexual reproductive health rights? Even across party lines?

Orwoba: I hate to be the person that says it. Women parliamentarians work towards the fight of representation, but they don’t work together. Most of my critics, of the people who have not really been supportive, have been women. I don’t know if it is inbuilt, but I would say as women parliamentarians of Kenya, we work towards representation of more women, but we don’t necessarily work together on it. That is the truth.

But why are women always being pushed to work together? Men are never being pushed to work together. Why should we always be united? As long as we are all working towards a common goal in our spaces, I don’t think the agenda should be uniting women for women. I think the agenda should be ensuring that every woman in a space of power and influence should be able to fight for more women.

HPH: What about male legislators?

Orwoba: Actually, male legislators have been more supportive towards the [sanitary towels] bill. For female legislators, it always feels like we are competing amongst each other. So it becomes a bit difficult to collaborate because it’s more about who is pushing the bill in terms of the mileage they get. Most of my partnerships are with the male legislators [for whom I] make it feel less awkward to …. just start talking about menstruation.

HPH: Last year, independent of your work as a parliamentarian, you launched something called “The Glo Pad Bank.” Tell us what that is.

Orwoba: After the stain incident, and all of the negative backlash and online bullying, I was, having a conversation with my sister and a couple of friends. And they said, you know what? I liked that you went and distributed pads. But, you know, you need to scale this up. You need to get a lot of people to bring you pads. And because we don’t want any kind of scandal related to money that is being sent to you.

HPH: Meaning, money is not always a useful tool in a country where corruption is high and rumors abound, right?

Orwoba: Exactly. So my friends said, how about we just, you know, station a 20-foot container somewhere, and people can just drop the pads? Simple. The next thing you know, one of the one of my friends said, I’m going to buy the container. There was no there was no working group. There was no think tank. It was really like, we don’t wanna deal with money. We want people to bring pads.

HPH: You want to launch Africa’s first menstruation museum. Can you share more about that?

Orwoba: You know, we take our kids to school. When they’re in school, they are going all the time to our museums. It doesn’t matter which country you come from; there is always a subject that will take kids in primary school, in high school, in universities to a museum, so that they can learn about history, or scientific things. You know, in Kenya, we are the cradle of mankind.

We show that in our museums. And I’m like—show where we came from, yes. And we all came from periods.

Back in the day, in Africa, there are many places where we had the period huts, where it was like a sacred place that you would be told to sleep and stay in because this is such a sacred time in your life. It’s like learning about how the world came about.

And over the years, we have had, such development in that space, you know? Like, who thought about a tampon? Why did they think about it? What informed that decision? All of that needs to be documented, displayed, for people to learn, understand, and appreciate So that by the time we are literally phasing off this stigma and this shame, it is not only because we have made loud campaigns over billboards about how you should be proud of your periods, but it’s also on the basis of the understanding of what the sanctity of menstruation is. And for me, that can only be done by educating our children from a very young age.

The post Battling period poverty in Kenya appeared first on Harvard Public Health Magazine.

Tuesday’s vote will have an enormous effect on how—and whether—Nyambura and countless other health workers and reproductive rights activists around the world can do their jobs. Thanks to a longstanding rule about abortion that shifts each time the White House changes political parties, every U.S. presidential election pits the American mood against other countries’ sovereignty—and the health of their women and girls.

Nyambura has seen what happens when U.S. interests conflict with Kenya’s own laws and standards of care. She grew up in a low-income settlement, where girls’ lives were upended when they became teenage mothers. Four years ago, her cousin, then 20 and pregnant, couldn’t afford maternal health care. Already a mother, she died of a postpartum hemorrhage, orphaning her children.

Nyambura sees her cousin’s death as a symptom of the long reach of domestic U.S. politics—in particular through the Mexico City Policy, better known as the “global gag rule,” and the ways it shapes U.S. global health efforts. The policy was first instituted by Ronald Reagan, who restricted recipients of U.S. aid for family planning from using other donors’ money to provide abortion. Since it was introduced in 1984, the policy has been repealed by every Democratic president and restored by every Republican one.

Most Republican presidents followed Reagan’s lead, restricting several hundred million dollars of family planning funding. But President Donald Trump expanded the Mexico City Policy to restrict nearly all U.S. global health assistance—a far wider channel of funding, totaling $7.3 trillion by his last year in office. His administration, like those before it, meant to reduce abortions with the policy, but research shows abortions actually increase in years when the “gag rule” is in place. And some experts say Trump’s more restrictive reversion not only undermined women’s health care—it weakened other countries’ health systems more generally, including in Kenya.

“The organizations we work with were caught in the situation where they had to choose between accepting U.S. government funding or any other funding—for any other program. For example, if an organization had received funding from a European source to work on abortion care [along with] some elements of contraceptive care, they were ineligible for U.S. government funding,” says Angela Akol, until recently the regional director of Ipas, a global non-governmental organization that seeks to expand access to safe abortion care.

Akol saw the universe of partners who could work on reproductive rights in Kenya shrink. U.S. funding is simply too big to forego: The U.S. is the biggest external donor to Kenya’s health sector, and the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) accounts for at least 60 percent of Kenya’s spending on HIV.

U.S. bureaucrats often insist abortion-related restrictions have the precision of a scalpel, but critics say that on the ground, they work like an axe, dismantling years of work, tearing through coalitions, and leaving millions of women and girls without the reproductive health care they need.

Nyambura knows it is impossible to attribute her cousin’s death directly to the rule. But she has also seen firsthand its profound ripple effects—even when the White House is controlled by Democrats and the policy isn’t in place.

Protecting the continuum of care

For this investigation, Harvard Public Health spoke with a dozen health workers, health sector leaders, and policy experts across the health sector in Kenya; most spoke anonymously to avoid potential professional or legal retaliation.

A U.S. State Department spokesperson, when asked for comment, underscored that President Joe Biden rescinded the Mexico City Policy upon taking office. The spokesperson told Harvard Public Health by email: “The United States has demonstrated committed leadership to global health while ensuring compliance with long-standing abortion-related restrictions on our foreign assistance.”

Nelly Munyasia, a trained nurse and midwife, is the head of Reproductive Health Network Kenya, a coalition of more than 600 health care professionals working in both private and public facilities. Her organization has created a network of referral facilities and support for women in need of comprehensive sexual and reproductive health care, including abortion care. In her view, the Mexico City Policy disrupts what she calls the “continuum of care” by wrongly assuming care providers like her can isolate abortion care from the rest of women’s health.

“No one opens a facility to just provide abortion care,” she says, “because no one comes in just for an abortion. They leave with a family planning method. You have to screen them for HIV if it’s a case of rape; [you] put them on pre-exposure prophylaxis. We are talking about access to contraceptives; we are talking about cancer screening and treatment.”

Saoyo Tabitha Griffith, deputy executive director of the health and human rights organization KELIN Kenya, says the U.S. anti-abortion regulations change the makeup of service delivery in Kenya—even long after the regulation changes. “Organizations known for offering holistic, 360-degree services stopped [doing so]. They started offering one-offs,” she says, describing care under Trump administration regulations.

Revoking the restrictions, as the Biden administration did, “doesn’t take away the loss of trust amongst your partners and peers.” Nor do patients automatically return, she adds. “The stroke of a pen . . . doesn’t erase the impact those four years have had.”

A dangerous legal gray area

In Kenya, the U.S. regulations stand in contradiction to the country’s own constitution, which allows for abortion when the procedure, in a health professional’s assessment, would safeguard the health or life of a pregnant woman. But there is no agreed-upon process for assessing when her health or life is at risk. Meanwhile, the country’s penal code—written by the British during the colonial period and adopted as national law at independence, in 1963—criminalizes both seeking and providing an abortion. Women could receive sentences of up to seven years in jail for seeking an abortion, and their health care providers could face up to 14 years in jail for providing one.

The contradiction between the penal code and Kenya’s more recent constitution, adopted in 2010, was supposed to be resolved by Parliament. It never has been. In recent years, anti-abortion groups have actively exploited this legal and policy stalemate by further blocking any attempts to pass progressive legislation. Health workers and researchers alike say that the resulting confusion undermines health care outcomes and service delivery.

Dorcus Muchiri, a doctor and OB-GYN, has experienced the impact of the policy lacuna. In 2008, a 16-year-old girl came to the clinic where she worked seeking an abortion. Staff there told her it was illegal and sent her away. Three days later, she returned, saying she was feeling unwell. In surgery, doctors discovered she had a perforated uterus, the result of an unsafe abortion attempt. “She died on our operating table,” she says.

At least 2,600 other women in Kenya also died from complications after seeking unsafe abortions that year. This case happened before the Kenyan constitution that permits abortion in some cases became law, but it still haunts Muchiri. Even now, she and other health workers say, the lack of clear guidelines means they err on the side of the Penal Code regulations that deem procuring or aiding in an abortion a crime. In the vast majority of cases, doctors only provide post-abortion care, Muchiri says, because that care is unambiguously legal: Medical regulations say that doctors are mandated to save a life by providing emergency services to patients facing imminent death.

“These are not medical lines that we are drawing,” she adds. “Even the supplies that are needed to save the life of a woman who has shown up bleeding from a self-procured [abortion] are the same ones [as] if she was seeking a safe termination. It’s the exact same kits, commodities, and equipment.”

U.S. domestic politics vs. Kenyan health sovereignty

U.S. policy has exacerbated Kenya’s challenges in reconciling its abortion laws. In 2012, the Ministry of Health launched guidelines for safe abortion, intended to bring clarity on the gray areas of Kenya’s laws and regulations and to guide clinicians and patients in making decisions about appropriate abortion care. But in 2013, the Ministry of Health’s director of medical services withdrew these guidelines—just one day after the senior health manager for the U.S. Agency for International Development (USAID) in Kenya sent an email to more than 50 USAID grantees, barring them from attending a ministry meeting where those guidelines would be discussed. In February 2014, the ministry further prohibited health care providers from receiving training on safe abortion procedures.

USAID did not respond to a request for comment. The U.S. State Department did not respond to questions about the impact of the Mexico City Policy on USAID policy or practice.

The stalemate on safe abortion guidelines sparked a protracted court case, which culminated in a landmark verdict, in 2019, that affirmed a constitutional right to abortion in certain circumstances. The ruling also restored the standards and guidelines for reducing morbidity and mortality from unsafe abortion. At least in theory, the ruling put to rest the contradiction between the Penal Code and the constitution.

But in practice, health workers told Harvard Public Health, confusion and fear still affect medical workers’ decisions, and many continue to follow the more restrictive Penal Code.

In these circumstances, clarity on clinical standards and guidelines around abortion became even more important; still, the bureaucratic process remained protracted. Last year, the ministry finalized guidelines around unsafe abortion as one among the five top causes of maternal mortality—but according to documents obtained by Harvard Public Health, resistance from anti-abortion groups pushed the ministry to cancel its public launch. “So officially, the people have copies of the guidelines, but they’ve not been launched,” says Kenneth Juma, a researcher at the African Population and Health Research Centre (APHRC) whose work focuses on maternal and reproductive health.

Kenya’s Ministry of Health did not respond to requests for comment.

Canceling the launch was not a minor bureaucratic detail; it was a missed opportunity to give official direction clarifying the issue, which is what all the stakeholders—especially medical providers—had been asking for over the years. “Guidelines are supposed to streamline and offer guidance . . . to actors within the health system space,” Juma explains. “So that is health care providers, but . . . patients benefit when there are clear guidelines. So anytime we do not have guidelines . . . there is confusion, [and] knowing abortion, people then self-censor, maybe over-restrict, or sometimes under-restrict whatever they are supposed to provide.”

Meanwhile, doctors say, the legal process has sidestepped an equally important issue: the wider context in which women and their providers face choices around their pregnancy.

“I’ve never been trained on termination of pregnancy for viable pregnancies, where the patient has a nonmedical reason to want one. It’s not a topic we discuss in medical school,” says Muchiri. “But to be frank, abortion is not just a medical question. It’s a social question—there are all kinds of social reasons why a pregnancy might be medically viable but not socially viable for the woman in question. We have to think of this as a bigger question that not only doctors can answer.”

Data show that U.S. anti-abortion regulations undermine sexual and reproductive health outcomes generally—even in countries where abortion is legal. In Kenya, some organizations that refused to be bound by the U.S. policy saw other funding dry up, amplifying the services shortage. Individual organizations, says Akol of Ipas, might try to comply with U.S. rules in the short-term and focus on staying open in the long term—but the patients they serve don’t have the same luxury.

“Women’s lives are not synced to the U.S. election cycle,” she says.

Juma, the APHRC researcher, says sexual and reproductive health nonprofits work in close collaboration, thanks both to tight budgets and to the vast terrain they must cover. “So when the U.S. comes and says, ‘You’re not allowed to partner; you’re not allowed to collaborate; you’re not allowed to share resources’ . . . you’ve fractured that collaboration,” he says. 

One HIV/AIDS organization in Nairobi was warned by USAID not to share space in its vehicle with groups that might transport “abortion-related commodities in their car since the car was procured with USAID funding,” he says. “You don’t even want to be seen in any meeting because even being seen in a meeting can have detrimental effects.”

This level of attention to partner activities has a chilling effect across the health sector, multiple providers told Harvard Public Health. “I never saw any USAID official on the ground,” says Griffith, of KELIN. “But what we saw was just overzealousness of our own partners. They wouldn’t even come to our meetings. . . . even when the meeting was on HIV and TB. They just don’t want to be associated with us.”

Whatever the outcome of the U.S. poll, Griffith worries about what could happen in just a few short months in Kenya. After four years of Biden, she says, if a Democrat loses, “all the efforts made to restore confidence, refund organizations that lost funding, and inform local communities about the availability of safe abortion services might be undone.”

Image: In a file photo from 2009, Dr. Aron Sikuku, right, explains family planning pills to Beatrice Ravonga, in a clinic in a Nairobi neighborhood. Family planning and reproductive health funding are often subject to the restrictive Mexico City Policy. (Khalil Senosi / AP Photo, File)

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