More non-hormonal contraceptives needed, experts say

The annulment of Roe v. Wade shed light on the availability of affordable and highly effective birth control in the United States. However, many young women do not want contraceptives from their mothers.

Even before the Supreme Court ruling, more and more women were asking about non-hormonal birth control options, said family physician Dr. Aviva Romm. in West Stockbridge, Massachusetts.

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

By some measures, there is 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 generic versions. In addition, the FDA is considering a request from a French pharmaceutical company to sell birth control pills over the counter.

Yet out of the long list of brands and devices, only a handful are hormone-free. Scientists and biotech startups have begun to develop new non-hormonal birth control methods, but they are still at the laboratory and animal study stage, and face a lack of funding. The available products are probably years away.

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

Hormone pills, second only to permanent sterilization, are the most common female contraceptives in the United States and are very effective in preventing pregnancy. The handful of contraceptives without hormones, 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 one hour before sex, was approved by the FDA in 2020 – the first new non-hormonal option authorized by the agency since the 1980s. Assuming typical use, Phexxi prevents the pregnancy at about the same rate as condoms.

Hormone-Free Birth Control Research

Effective, non-hormonal choices are important, said Daniel Johnston, chief of the National Institutes of Health’s Contraception Research Branch. There was excitement in his voice as he spoke of promising, albeit extremely early, research: Scientists have discovered antibodies that attach to sperm to prevent them from swimming and targeted drugs that would block receptors necessary for the production of spermatozoa.

A sperm-blocking drug, which start-up YourChoice Therapeutics, in Berkeley, Calif., is developing as the first “male birth control pill”, has sparked buzz, especially among those who think birth control responsibility is not should not rest exclusively with those with uteri.

Recent studies have shown the pill to work in mice, monkeys, rats, and dogs. It will take years to see if it is safe and effective for humans. On average, drug development takes about a decade, and the “male birth control pill” is too early in that timeline to even have a name. For now it is known as YCT529.

YourChoice chief executive Akash Bakshi and co-founder Nadja Mannowetz started the company to develop non-hormonal options for both biological sexes, Bakshi said. It turns out that the science was more advanced for the drug targeting male sperm.

It has to do with biology. The male body generates around 1,500 sperm per second, while the female body is born with a finite number of eggs, Johnston said. Drugs that target male sperm without harming the stem cells that make more of it, or by blocking a receptor needed to make sperm like YCT529 does, could, in theory, be reversible. A male body might produce more sperm afterwards.

In female bodies, on the other hand, “if you destroy the pool of eggs, the show is over,” Johnston said. This doesn’t mean that non-hormonal contraceptives designed to act on the female body aren’t possible, but those that target male sperm might come first.

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

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

“Nowhere else is there the type of investment in the reproductive health space as anywhere else,” he said.

Where is the demand for new birth control?

The Roe decision amplifies the urgency.

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

The NIH funds research into early-stage non-hormonal birth control, but Johnston agreed that the investment in methods is not where it needs to be. Products can’t make it to drugstore shelves unless the biopharmaceutical industry steps in to fund drug development, but it’s unclear how many women want hormone-free birth control options. Pharmaceutical companies generally want to see a clear demand before investing in a product.

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

“From a business perspective, the contraceptive market appears to be healthy and growing,” read a 2020 commentary in the journal Nature. “Yet women’s demand for transformational change is not translating into reduced sales.”

The side effects of hormonal birth control are minimal, but in rare cases they can cause blood clots or other serious conditions. A survey published in the Journal of Women’s Health in 2021 found that while most were satisfied with their contraceptive options, the highest proportion of women who wanted a different method were those who used hormonal contraceptives. According to the survey, those who used non-hormonal methods were almost six times more likely to say they were satisfied with their current methods than those who used hormonal methods.

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

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

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

When hormones are not an option

According to Nature’s commentary, about one-third of women worldwide stop hormonal methods of birth control within the first year of taking them, often due to side effects.

Such was the case with Lenise “Sunny” Wilson, who attributes severe depression to the birth control pills she was taking.

“It completely changed who I was as a person,” said Wilson, 38, of Tucson, Arizona. “It messed up my emotions and my sanity 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, cannot take hormonal birth control. Erica Twidle, 33, of Gallatin, Tennessee, was diagnosed with a rare heart condition called peripartum cardiomyopathy while pregnant with her daughter, Della. The condition left Twidle’s heart weak and enlarged, and although she eventually recovered, Twidle’s doctors told her she should never take hormonal contraception or become pregnant again. Both would put his heart in danger.

Twidle, who had had a bad experience with the copper IUD in the past, decided to go on 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 that I had to stay alive for.

Twidle calls herself “one of the lucky ones”, as her heart remained strong enough to endure the pregnancy. But if things had changed, Twidle was willing to have an abortion to stay alive.

That 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 wants women in her position — including the 1,000 to 1,300 women affected by peripartum cardiomyopathy each year — to have more hormone-free options.

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

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