A 'Plan A' for men

The ideas and innovators shaping health care
Apr 03, 2024 View in browser
 
Future Pulse

By Ruth Reader, Carmen Paun and Erin Schumaker

THE LAB

NEXT Life Sciences CEO Luke R. Fox

Fox | Courtesy of NEXT Life Science

For decades, the responsibility for birth control has disproportionately fallen on women. Now, several companies are working on male birth control.

Male contraception is in demand. Between 2014 and 2021, the rate of vasectomies among men 18-64 grew 26 percent, according to one study. Vasectomies jumped again after the Supreme Court overturned the constitutional right to an abortion in 2022.

In the U.K., an oral contraceptive has entered safety trials. But two companies, NEXT Life Sciences and Contraline, are each exploring the possibility of using hydrogel to block sperm. Both have clinical trials underway.

Ruth sat down with NEXT Life Sciences CEO Luke R. Fox to talk about his company’s male contraceptive, Plan A, and the future of male birth control.

The interview has been edited for length and clarity.

What is Plan A?

It's a hydrogel that gets injected into the vas deferens and it forms into a flexible filter that blocks everything that's larger than one micron, which includes sperm.


What is the procedure like?

We’ve tried different methods. One being a needle method, which is similar to any other injection. The other is with a flexible inserter. Instead of having to use a needle to pierce through, we use a small separator, which opens up and exposes the vas deferens [or sperm duct]. The same separator is used in vasectomy, but it doesn’t require cauterizing or causing permanent damage.

How long does it last?

We are designing it to last at least 10 years.

Is it reversible?

It’s reversible through an injection of sodium bicarbonate, which transforms [the hydrogel] from that flexible filter that is bioadhesive and designed to be long-term durable, into the consistency of water. And so it just simply gets flushed out.

What’s next?

While there’s been numerous studies done overseas, in humans as well as preclinical testing that’s been done here in the United States, the final step is clinical testing under FDA guidance here in the United States. There’ll be a one-year trial that will allow us to launch in 2026.

 

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POLICY PUZZLE

Nora Volkow, Director of the National Institute on Drug Abuse, testifies during a Senate Appropriations Subcommittee on Labor, Health and Human Services, and Education, and Related Agencies, hearing about the National Institutes of Health budget requests, Thursday, May 4, 2023, on Capitol Hill in Washington. (AP Photo/Jacquelyn Martin)

Dr. Nora Volkow, director of the National Institute on Drug Abuse, says the U.S. needs to build up prevention infrastructure to beat the drug overdose death crisis. | AP

Substance use prevention and interventions targeted to the most vulnerable groups will help America get itself out of the ongoing drug overdose death crisis, Dr. Nora Volkow, director of the National Institute on Drug Abuse, told Rx and Illicit Drug Summit attendees Tuesday in Atlanta.

“There are multiple evidence-based prevention interventions for which the science shows they work. Why are they not implemented sufficiently?” she wondered.

They include decreasing risk for substance use, such as addressing early aggressive behavior and poor social skills, and supporting positive relationships and anti-drug use policies, according to data Volkow presented at the conference.

She said NIDA has asked the National Academies of Sciences, Engineering and Medicine to prepare a list of recommendations and policies for drug-use prevention.

“We need to help create an infrastructure in our country, just like we have for the treatment of health care conditions, that can be utilized for delivering and driving prevention for behavioral health,” she said.

Volkow also warned that some racial and ethnic groups haven’t yet experienced a drop in the number of overdose deaths.

The overdose mortality rate among American Indians and Alaskan Natives is double that of the U.S. average, she said. In Black American communities, the mortality from overdoses is 50 percent higher than in the rest of the country, Volkow said.

“So our interventions, while they basically seem to be having some positive effects among white Americans, are not necessarily touching those very vulnerable groups,” she said.

In response, a NIDA project that started this year will help tribal nations identify research needs and interventions to try to prevent overdose deaths, Volkow said.

In the end, the NIDA boss delivered a hopeful message: “I have no doubt that we will overcome the overdose crisis,” she said. Volkow did wonder, however, how long it would take.

 

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WASHINGTON WATCH

Rep. Cathy McMorris Rodgers (R-Wash.).

House Energy and Commerce Committee Chair Cathy McMorris Rodgers is among the lawmakers in the fight over NIH funding. | Francis Chung/POLITICO

House Republicans have kicked off the latest round in a fight over National Institutes of Health funding.

The group — House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-Wash.), Subcommittee on Health Chair Brett Guthrie (R-Ky.), and Subcommittee on Oversight and Investigations Chair Morgan Griffith (R-Va.) — wants the Government Accountability Office to investigate NIH safeguards for research funding to China.

That's according to a Tuesday letter by McMorris Rodgers, Guthrie and Griffith to the GAO's Comptroller General.

"Recent reports have raised concerns about the NIH’s ability to screen for national security issues," they wrote, citing a Vanity Fair investigation into U.S.-funded biology research and an audit by the HHS Office of the Inspector General into NIH's foreign aid grants.

"Concerns about the NIH’s ability to vet foreign collaborators have also arisen from the Committee’s investigation of the origins of the COVID-19 pandemic," they added.

Zoom out: This is the latest in a series of investigations into NIH in the wake of the pandemic.

While those probes have primarily been driven by GOP members like Sen. Rand Paul (R-Ky.), last month Gary Peters (D-Mich.), chair of the Senate Homeland Security and Governmental Affairs Committee, joined Paul in launching an investigation into "national security threats posed by high-risk biological research and technology" at NIH.

The bottom line: After a decade of generous funding from Congress, with average boosts of 5 percent year-over-year, NIH is grappling with a nearly flat budget in fiscal year 2024.

 

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