Why aren't there hormone-free birth control pills? Roe puts spotlight on contraceptives

The overturn of Roe v. Wade has put a spotlight on the availability of affordable, highly effective birth control in the U.S. Many younger women, however, don’t want their mothers’ contraceptives.

Even before the Supreme Court decision, more women had been asking about nonhormonal birth control options, said Dr. Aviva Romm, a family medicine physician in West Stockbridge, Massachusetts.

“People are more educated than ever about the importance of what they put in their bodies,” said Romm, author of “Hormone Intelligence.” “Hormonal birth control has barely changed since it was first discovered, and women want an alternative.”

By some measures, there's no shortage of birth control. The Food and Drug Administration has approved more than 250 contraceptives, and the Affordable Care Act mandates insurance coverage, at least for the generic versions. In addition, the FDA is considering a French pharmaceutical company's request to sell over-the-counter birth control pills.

Yet, out of the long list of brands and devices, only a handful are free of hormones. Scientists and biotech startups have started to develop new nonhormonal birth control methods, but they're still in the lab and animal study stage, and face a lack of funding. Available products are likely years away.

Most hormonal contraceptives — which include the birth control pill, the long-acting patch, injections, the vaginal ring, the implant and the intrauterine device, or IUD — contain synthetic versions of the same two sex hormones, progesterone and estrogen.

Hormonal pills, second only to permanent sterilization, are the most common female contraceptives in the U.S. and are highly effective at preventing pregnancy. The handful of hormone-free contraceptives, such as diaphragms or cervical caps, don't work as well. Condoms can have a high failure rate.

Phexxi, a vaginal gel meant to be inserted an hour before sex, was approved by the FDA in 2020 — the first new nonhormonal option cleared by the agency since the 1980s. Assuming typical use, Phexxi prevents pregnancy at about the same rate as condoms.

Research on hormone-free birth control

Effective, nonhormonal choices are important, said Daniel Johnston, chief of the National Institutes of Health Contraception Research Branch. There was excitement in his voice as he talked about promising, albeit extremely early, research: Scientists have discovered antibodies that glom on to sperm to stop them from swimming, and have targeted drugs that would block receptors needed to make sperm.

One sperm-blocking drug, which the startup YourChoice Therapeutics, in Berkeley, California, is developing as the first “male birth control pill,” has generated buzz, especially among those who believe the responsibility of birth control shouldn’t fall exclusively on those with uteruses.

Recent studies showed the pill worked in mice, monkeys, rats and dogs. It will take years to see whether it’s safe and effective for humans. On average, developing a drug takes about a decade, and the “male birth control pill” is too early in that timeline to even get a name. For now, it’s known as YCT529.

YourChoice chief executive Akash Bakshi and co-founder Nadja Mannowetz launched the company to develop nonhormonal options for both biological sexes, Bakshi said. It just happened that the science was more advanced for the drug targeting male sperm.

That has to do with biology. The male body generates about 1,500 sperm per second, whereas the female body is born with a finite number of eggs, Johnston said. Drugs targeting the male sperm without harming the stem cells that make more, or blocking a receptor needed to make sperm the way YCT529 does, could, in theory, be reversible. A male body could make more sperm afterward.

In female bodies, on the other hand, “if you destroy the pool of eggs, show’s over,” Johnston said. This doesn’t mean nonhormonal contraceptives designed to act on the female body aren’t possible, but the ones targeting male sperm could come first.

Another company, Mucommune in Durham, North Carolina, is developing a monoclonal antibody that makes sperm unable to swim. Rather than giving the antibody to men, though, the company’s founder, Samuel Lai, wants to give women a vaginal ring they could wear for their whole menstrual cycle that releases the antibody. When sperm enter the vagina, they’d be frozen in their tracks, unable to reach the egg for fertilization.

The antibodies worked well in animals, but like YourChoice’s male pill, the sperm-stopping antibody still has many years of testing ahead. Lai said the whole process could be faster with more funding.

“There is nowhere near the type of investment in the reproductive health space as anywhere else,” he said.

Where's the demand for new birth control?

The Roe decision amplifies the urgency.

With more open conversation about contraceptive needs, the next decade could be “an exciting time for nonhormonal contraception,” Lai said. These conversations, he believes, could help pharmaceutical investors see a real demand.

NIH funds early stage nonhormonal birth control research, but Johnston agreed that investment in the methods isn’t where it needs to be. Products can’t get to pharmacy shelves unless the biopharma industry steps in to fund drug development, but it’s difficult to determine how many women want hormone-free birth control options. Pharmaceutical companies usually want to see clear demand before investing in a product.

Worldwide, there were more than 151 million users on the hormonal pill in 2019, according to to a report from the United Nations. Analysts say sales of all hormonal contraceptives made the global market for these options worth more than $15 billion in 2020 — a value that’s estimated to grow to more than $20 billion by 2030.

“From a business perspective, the contraceptive market seems to be healthy and growing,” reads a 2020 commentary in the journal Nature. “Yet the demand from women for transformational change is not reflected as a reduction in sales.”

Side effects of hormone contraceptives are minimal, but they can, in rare cases, cause blood clots or other serious conditions. A survey published in the Journal of Women’s Health in 2021 found that although most were satisfied with their birth control options, the highest proportion of women who wanted a different method were those using hormonal contraceptives. Those using nonhormonal methods were close to six times as likely to say they were satisfied with their current methods than those on hormonal methods, according to the survey.

“Hormonal contraceptives work tremendously well,” said Johnston. “But they basically involve the changing of the expression of hundreds, if not thousands, of genes, to give you the effect.”

The hormones do more than control when women — or trans men, nonbinary people and others who ovulate — can get pregnant. They regulate everything from sleep patterns to metabolism, blood pressure, bone density, hair growth, skin and the brain.

“It’s not something that needs to be scary, but it does need to be taken seriously,” said Sarah Hill, a psychology professor at Texas Christian University in Fort Worth, of hormonal birth control’s effect on the brain. Hill is author of “This Is Your Brain on Birth Control.”

When hormones aren't an option

According to the Nature commentary, about one-third of women globally discontinue hormonal birth control methods within the first year of taking them, often because of side effects.

That was the case for Lenise “Sunny” Wilson, who attributes severe depression to the birth control pills she had been taking.

“It completely changed who I was as a person,” said Wilson, 38, of Tucson, Arizona. “It messed with my emotions and my mental health so intensely.”

Wilson has since stopped taking the pill and, for the most part, she said, has returned to her sunny self.

Some women, including those with certain cancers and heart conditions, can’t take hormonal birth control. Erica Twidle, 33, from Gallatin, Tennessee, was diagnosed with a rare heart condition called peripartum cardiomyopathy while pregnant with her daughter, Della. The condition made Twidle’s heart weak and enlarged, and although she eventually recovered, Twidle’s doctors told her she shouldn’t take hormonal birth control, or get pregnant, ever again. Both would jeopardize her heart.

Twidle, who’d had a bad experience with the copper IUD in the past, decided to track her cycle. But nine months after having Della, she was pregnant again. “I cried when I found out,” she said. “I was terrified. I had a child I needed to stay alive for.”

Twidle calls herself “one of the lucky ones,” since her heart stayed strong enough to support pregnancy. But had things taken a turn, Twidle was prepared to get an abortion to stay alive.

This was three years ago, but Twidle would have fewer choices now.

In Tennessee, abortion is now a crime. The state makes exceptions for the life of the mother, but Twidle wishes women in her position — including the 1,000 to 1,300 women affected by peripartum cardiomyopathy each year — had more hormone-free options.

“As simple as it sounds to ‘just take birth control,’” she said. “Sometimes you can’t.”

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