You can reach her a lcarr@mjhlifesciences.com.

Lindsey Carr, Editor

The Department of Health and Human Services’ (HHS) Secretary Xavier Becerra held a press conference today to share the department’s plans as the shifting landscape of abortion care unfolds in courthouses nationwide.

During the conference, Becerra detailed how the department will safeguard access to medication abortion and protect the safety of women traveling out of state for abortion care. The conference was held in response to President Joe Biden’s directive on Friday that called on the HHS to act following the Supreme Court’s decision to overturn Roe v Wade.

Becerra began the press conference with a reminder that federal law requires government programs to provide medication abortion in limited cases (life of the mother, rape, or incest), emphasizing that government agencies must continue providing these services.

He directed the Office of Civil Rights to protect privacy and nondiscrimination for patients seeking abortion care and for providers.

The HHS, said Becerra, will examine its authority under the Emergency Medical Treatment Act to ensure that clinical judgement of hospitals and abortion care providers is supported. All agencies within HHS will also make sure that abortion care providers—including pharmacists and clinicians—have adequate training and resources to address family planning needs, such as referrals and patient education.

“Health care is a matter to be decided by patients and their providers, not politicians,” Becerra said as he urged the Centers for Medicare and Medicaid Services to pursue every legally available step to safeguard family planning care and access to contraception.

HHS plans to issue guidance to providers regarding medication abortion and will work with the Attorney General and the Justice Department to prohibit states from banning it.

Becerra visited a Planned Parenthood clinic in St. Louis, Missouri, on Friday morning when the decision was announced, where he witnessed the clinic director turning away patients almost immediately. “People in the room were visibly shaken, there were tears and an unshakeable sense of sadness,” he said.

Across state lines in Illinois, abortion care was still legal. “It was shocking that, in the United States of America, a short drive can make such a dire and draconian difference in health care outcomes,” he said. “The impact was visible and real.”

“We will do everything within the legal limit of the law to reach patients and support providers,” Becerra said as the conference concluded. “I stand with you, and I have your back.”

Remarks by President Biden on the Supreme Court Decision to Overturn Roe v. Wade | The White House. The White House. Published June 24, 2022. Accessed June 28, 2022. https://www.whitehouse.gov/briefing-room/speeches-remarks/2022/06/24/remarks-by-president-biden-on-the-supreme-court-decision-to-overturn-roe-v-wade/

Remarks by Secretary Xavier Becerra at the Press Conference in Response to President Biden’s Directive following Overturning of Roe v. Wade. HHS.gov. Published June 28, 2022. Accessed June 28, 2022. https://www.hhs.gov/about/news/2022/06/28/remarks-by-secretary-xavier-becerra-at-the-press-conference-in-response-to-president-bidens-directive-following-overturning-of-roe-v-wade.html

Articles

“The impact was visible and real,” said Xavier Becerra, secretary of the US Department for Health and Human Services during a press conference Tuesday. 

HHS secretary details department’s efforts to protect reproductive health care

 on Friday triggered a domino effect of antiabortion legislation across the country. While some states had automatic trigger bans in place, others required state action for the ban to take effect. 

Below is a snapshot of the current status of abortion restrictions: banned or mostly banned, heavily restricted, and protected.

We will update this map as new information becomes available. Follow along for coverage. 

Source: Guttmacher Institute. Lay of the Land: Abortion Policies and Access in the United States. Guttmacher.org. Published 2022. Accessed June 28, 2022. https://states.guttmacher.org/policies/minnesota/abortion-policies

Snapshot of abortion restrictions in the United States.

Current landscape of abortion restrictions in the United States

Having an impact: How you can help your patients in the wake of Roe v Wade overruling

How you can help patients during the current attack on their reproductive autonomy

Not just abortion: How the demise of Roe v Wade may impact fertility care

Two reproductive health experts discuss the next potential threat to reproductive rights. 

COVID-19 pregnancy data in the United States: June 29 update

Data on COVID-19 during pregnancy, as reported by the CDC, in collaboration with state, local, and territorial health departments and external partners.

Risk assessment and management of brain arteriovenous malformations in pregnancy

Incidence and mortality of neonatal preterm birth

Despite a global decrease in the incidence and morality of neonatal preterm birth from 1990 to 2019, in Southern Sub-Saharan Africa there remains an increasing trend in the overall age-standardized incidence rate (ASIR) in high sociodemographic index (SDI) regions and in the age-standardized mortality rate (ASMR), according to a study in JAMA Pediatrics.

What's coming to Contemporary OB/GYN® this week? 

This week on Contemporary OB/GYN®: June 27 to July 1

EPA releases new advisories for PFAS levels in drinking water

Essentially no safe levels of toxic ‘forever chemicals’ found in many US water systems.

Relugolix demonstrates positive phase 3 data as combination therapy for endometriosis pain

Results suggest the potential of this oral therapy to address the unmet clinical need for long-term medical treatment for endometriosis.

Evofem Biosciences announces results of post hoc analysis of phase 3 clinical trial data

Evofem Biosciences, Inc. recently announced results of a post hoc analysis of the registrational Phase 3 AMPOWER trial, which investigated the ability of a contraceptive gel consisting of lactic acid, citric acid, and potassium bitartrate (Phexxi; Evofem) to prevent pregnancy.

Berberine promising therapy to treat vulvovaginal candidiasis

Vaginal yeast infections were successfully treated with berberine, a biologically active herbal alkaloid, according to a study published in Frontiers in Pharmacology.

Women with PCOS at increased risk of cardiovascular complications during pregnancy

Using National Inpatient Sample data from a nearly 2 decade period, investigators detail the increased risk of cardiovascular complications among women with PCOS during delivery hospitalizations and predictors of this increased risk.

Exposure to 'forever chemicals' linked to increased risk of hypertension

New research suggests cumulative exposure to PFAS could increase risk of incident hypertension by 71% among midlife women.

In case you missed it: June 20 to June 24

The United States Environmental Protection Agency (EPA) recently released new health advisories for toxic chemicals known as per- and polyfluoroalkyl substances (PFAS).

 Also called ‘forever chemicals,’ PFAS are resistant to disintegration and present in the blood of humans and animals, and found in water, air, fish, and soil across the globe.

The new advisories cut the safe level of the chemical Perfluorooctanoic acid (PFOA) more than 17,000 times what the EPA previously deemed acceptable for public health, to now just 4 parts per quadrillion. They also reduced safe levels of perfluorooctyl sulfonate (PFOS)—another PFAS chemical—by a factor of 3,500.

The advisories essentially declare any detectable amounts of PFOA and PFOS unsafe for consumption. PFAS exposure—even in miniscule amounts—has been linked to serious and lifelong consequences. They cross the placenta the same way vitamins and minerals do and can impact thyroid hormone levels and hinder in-utero growth and brain development.

 Prenatal and after-delivery exposure may also lead to low birth weight, childhood obesity, and heightened risk of infection later in life. Based on current understanding, the benefits of breastfeeding appear to outweigh the risks for infants exposed to PFAS in breast milk.

The Environmental Working Group (EWG)—an American nonprofit group dedicated to advocacy and research on agricultural subsidies, toxic chemicals, drinking water pollutants, and corporate accountability—have tracked PFOA, PFOS, and other PFAS chemicals in drinking water. They are not yet officially regulated, so water systems are not required to test for them.

Senior vice president with EWG, Scott Faber, said that at least 1,943 public water suppliers across the country have been found to contain some amount of PFOS and PFOA.

“This will set off alarm bells for consumers, for regulators, and for manufacturers, who thought the previous [advisories] were safe,” Faber said. “I can't find the words to explain what kind of a moment this is…The number of people drinking what are, according to these new numbers, unsafe levels of PFAS, is going to grow astronomically.”

The EPA plans to release a formal drinking water regulation for PFOS, PFOA, and potentially other chemicals, in the fall of 2022. It is also inviting states and territories to apply for $1 billion—the first of $5 billion in Bipartisan Infrastructure Law grant funding—to address PFAS and other drinking water contaminants, primarily in small or disadvantaged communities.

1. EPA Announces New Drinking Water Health Advisories for PFAS Chemicals, $1 Billion in Bipartisan Infrastructure Law Funding to Strengthen Health Protections | US EPA. US EPA. Published June 15, 2022. Accessed June 23, 2022. https://www.epa.gov/newsreleases/epa-announces-new-drinking-water-health-advisories-pfas-chemicals-1-billion-bipartisan

2. PFAS Explained | US EPA. US EPA. Published March 30, 2016. Accessed June 23, 2022. https://www.epa.gov/pfas/pfas-explained

3. Per- and Polyfluoroalkyl Substances (PFAS) | US EPA. US EPA. Published March 30, 2016. Accessed June 23, 2022. https://www.epa.gov/pfas

4. Parkersburg, West Virginia. The PFAS Project Lab. Published April 21, 2017. Accessed June 23, 2022. https://pfasproject.com/parkersburg-west-virginia/

5. Our Current Understanding of the Human Health and Environmental Risks of PFAS | US EPA. US EPA. Published October 14, 2021. Accessed June 23, 2022. 

https://www.epa.gov/pfas/our-current-understanding-human-health-and-environmental-risks-pfas

6. PFAS Strategic Roadmap: EPA’s Commitments to Action 2021-2024 | US EPA. US EPA. Published October 14, 2021. Accessed June 23, 2022. https://www.epa.gov/pfas/pfas-strategic-roadmap-epas-commitments-action-2021-2024

Myovant Sciences and Pfizer recently announced positive results of the phase 3 SPIRIT 1 and SPIRIT 2 studies evaluating the investigational combination therapy of relugolix, estradiol and norethindrone acetate (Myfembree; Myovant and Pfizer) for moderate to severe endometriosis-associated pain.

In both studies, 75% of women using the once daily relugolix combination therapy experienced a significant reduction in dysmenorrhea, compared to 27% and 30% of women in the placebo groups at Week 24, respectively (both 

< 0.0001). Relugolix combination therapy also significantly reduced non-menstrual pelvic pain in 59% and 66% of women, compared to 40% and 43% in the placebo groups (

In SPIRIT 1 and 2, the relugolix combination therapy group also showed reductions in dyspareunia and opioid use compared to the placebo groups. Additionally, more women undergoing relugolix combination therapy were opioid free at Week 24 compared with placebo (86% and 82% vs 76% and 66%, respectively).

The most frequently reported adverse events by women in both the relugolix combination therapy and placebo groups included headaches, nasopharyngitis, and hot flashes.

Currently, the relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) is available in the United States as Myfembree for the management of uterine fibroid-related heavy menstrual bleeding in premenopausal women.

“The data [from SPIRIT 1 and 2] underscore the value relugolix combination therapy may provide as a potential new treatment option for women with endometriosis-associated pain,” said Juan Camilo Arjona Ferreira, MD, chief medical officer of Myovant Sciences.

According to the studies’ authors, “this oral therapy has the potential to address the unmet clinical need for long-term medical treatment for endometriosis, reducing the need for opioid use or repeated surgical treatment.”

Data from SPIRIT 1, SPIRIT 2, and an open-label extension study were included in a supplemental New Drug Application for the relugolix combination tablet for the management of moderate to severe endometriosis pain with a target Prescription Drug User Fee Act of August 6, 2022.

Myovant Sciences and Pfizer Announce Publication in The Lancet of Phase 3 SPIRIT 1 and SPIRIT 2 Studies of Once-Daily Relugolix Combination Therapy in Women With Endometriosis-Associated Pain | Myovant Sciences Ltd. Myovant Sciences Ltd. Published 2022. Accessed June 22, 2022. 

https://investors.myovant.com/news-releases/news-release-details/myovant-sciences-and-pfizer-announce-publication-lancet-phase-3

Giudice LC, As-Sanie S, Arjona Ferreira JC, et al. Once daily oral relugolix combination therapy versus placebo in patients with endometriosis-associated pain: two replicate phase 3, randomised, double-blind, studies (SPIRIT 1 and 2). 

. 2022;399(10343):2267-2279. doi:10.1016/s0140-6736(22)00622-5