Federal health officials have approved the first pill specifically intended to treat severe depression after childbirth, a condition that affects thousands of new mothers in the U.S. each year.

The Food and Drug Administration on Friday granted approval of the drug, Zurzuvae, for adults experiencing severe depression related to childbirth or pregnancy. The pill is taken once a day for 14 days.

“Having access to an oral medication will be a beneficial option for many of these women coping with extreme, and sometimes life-threatening, feelings,” said Dr. Tiffany Farchione, FDA’s director of psychiatric drugs, in a statement.

Postpartum depression affects an estimated 400,000 people a year, and while it often ends on its own within a couple weeks, it can continue for months or even years. Standard treatment includes counseling or antidepressants, which can take weeks to work and don’t help everyone.

The new pill is from Sage Therapeutics, which has a similar infused drug that’s given intravenously over three days in a medical facility. The FDA approved that drug in 2019, though it isn’t widely used because of its $34,000 price tag and the logistics of administering it.

The FDA’s pill approval is based on two company studies that showed women who took Zurzuvae had fewer signs of depression over a four- to six-week period when compared with those who received a dummy pill. The benefits, measured using a psychiatric test, appeared within three days for many patients.

Sahar McMahon, 39, had never experienced depression until after the birth of her second daughter in late 2021. She agreed to enroll in a study of the drug, known chemically as zuranolone, after realizing she no longer wanted to spend time with her children.

“I planned my pregnancies, I knew I wanted those kids, but I didn’t want to interact with them,” said McMahon, who lives in New York City. She says her mood and outlook started improving within days of taking the first pills.

“It was a quick transition for me just waking up and starting to feel like myself again,” she said.

Dr. Kimberly Yonkers of Yale University said the Zurzuvae effect is “strong,” and the drug likely will be prescribed for women who haven’t responded to antidepressants. She wasn’t involved in testing the drug.

Still, she said, the FDA should have required Sage to submit more follow-up data on how women fared after additional months.

“The problem is we don’t know what happens after 45 days,” said Yonkers, a psychiatrist who specializes in postpartum depression. “It could be that people are well or it could be that they relapse.”

Sage did not immediately announce how it would price the pill, and Yonkers said that’ll be a key factor in how widely it’s prescribed.

Side effects with the new drug are milder than the IV version and include drowsiness and dizziness. The drug was co-developed with fellow Massachusetts pharmaceutical company Biogen.

Both the pill and IV forms mimic a derivative of progesterone, the naturally occurring female hormone needed to maintain a pregnancy. Levels of the hormone can plunge after childbirth.

Sage’s drugs are part of an emerging class of medications dubbed neurosteroids. These stimulate a different brain pathway than older antidepressants that target serotonin, the chemical linked to mood and emotions. 
…

your ad here

The United States took over the rotating presidency of the U.N. Security Council on Tuesday for the month of August. The Biden administration has used the opportunity to draw attention to global food insecurity, particularly how conflict is a major driver of hunger.

U.S. Ambassador to the United Nations Linda Thomas-Greenfield spoke Friday to VOA about how Russia’s invasion of Ukraine and its withdrawal from the Black Sea Grain Initiative have impacted international food security. She also discussed U.S. concerns about the attempted military coup in Niger, relations with China at the U.N., and other priority issues for the United States.

The following interview has been edited for brevity and clarity.

VOA: This is your third time sitting in the Security Council chair as president and the third time you’ve used this opportunity to focus on global food insecurity. So, tell us what you hope to achieve drawing the council’s attention to this issue, and how it could make a positive difference on the ground.

Linda Thomas-Greenfield, U.S. ambassador to the United Nations: This has been a priority for the administration. It has been a priority for me since I arrived here in New York. And as you know, this is the third time that I will be focusing on this issue. It has gotten worse. It has gotten worse because of Russia’s unprovoked war on Ukraine.

More than 170 million people have been impacted by conflict, and the conflict that we see in Russia is certainly contributing to that. So, we are focusing on the issue of food being used as a weapon of war. And there is no better example of that — no worse example of that — than what Russia is doing as it relates to Ukrainian grain being allowed to get into the market to reach the people in Africa, in the Middle East, elsewhere in the world who are dependent on grain coming out of Ukraine.

VOA: On the grain, is a return to the Black Sea grain deal, is that even possible now after Russia has spent the last couple of weeks bombing infrastructure at multiple Ukrainian ports?

Thomas-Greenfield: Russia’s bombing of Ukrainian ports and infrastructure is unacceptable, and of course is making the situation even worse. But I know that [U.N.] Secretary-General [Antonio] Guterres and OCHA [the U.N. office of humanitarian affairs] are continuing to attempt to bring the Russians back into the grain deal. The government of Turkey has also been engaged with the Russians to urge them to come back into this deal. Other countries in the world have issued statements urging Russia to come back into the deal. So, we remain guardedly hopeful, but in the meantime, the impact of this on the world’s market is really, really devastating.

VOA: What are you hearing from some of your counterparts here at the U.N. about that, from other countries, especially in the Global South?

Thomas-Greenfield: Well, we had a Security Council high-level meeting yesterday, where countries from all over the world, including many countries from the Global South, spoke. They all called on Russia to return to the grain deal. They expressed their concerns about the impact this is having on food supplies around the world, and I think the Russians heard the message loudly and clearly that they need to return to this deal. But this is not the only place where Russia has had such a devastating impact on the humanitarian situation. Just look at the situation on the border with Turkey and Syria, where Russia vetoed the resolution that would have allowed for the continuation of needed humanitarian assistance to reach the Syrian people across the border.

VOA: Speaking of Russia, there’s a bit of breaking news today from Moscow. Russian opposition leader Alexei Navalny has been sentenced to a further 19 years in prison on extremism charges. Your reaction?

Thomas-Greenfield: Sad but not surprised. It is clear that the Russian government, that Putin, that this authoritarian government, will use any means to restrict the voices of the opposition, restrict the voices of criticism. Navalny represents that. He is being held in an unacceptable way. He should not have been in this court system, and we condemn the actions of the Russian government as it relates to him.

VOA: Moving to another council member — there’s been a lot of talk and analysis about U.S.-China relations recently. How would you characterize U.S.-China relations here at the United Nations, and are there any areas where you’ve been able to cooperate?

Thomas-Greenfield: We sit on the Security Council together. We are both permanent members of the Security Council; we’re part of the P5 [P5 is a nickname for the five permanent members of the Security Council]. We do work together on issues of mutual interests, and there are issues where we have differences. And certainly, we have significant differences as it relates to Russia’s unprovoked war in Ukraine. We have differences on how we should respond to the DPRK [North Korea] threats. But there are areas where we’re working together with them. We were able to get a resolution on BINUH [the U.N. Integrated Office in Haiti] — this is the Haiti resolution — passed and will hopefully be able to work again with them on Haiti.

VOA: Niger: The ECOWAS [Economic Community of West African States] deadline for the military to reverse the coup and restore President [Mohamed] Bazoum is quickly approaching, but the military seems to be doubling down in the face of possible ECOWAS action. So how worried is Washington that this crisis could rapidly evolve into a regional conflict?

Thomas-Greenfield: We have been very, very clear in our support for ECOWAS, for ECOWAS’s statements, for ECOWAS’s involvement in trying to find a solution. They have called for the military to step aside to restore President Bazoum, who was democratically elected. We support the president, and we continue to support the Nigerien people. This is an unacceptable action by the military, and we have to work together with the region to try to push back on this.

VOA: And have nonessential U.S. personnel and their families begun departing Niger?

Thomas-Greenfield: We are in the process of removing some American citizens in an ordered departure. But our embassy remains open. Our diplomatic contacts with the various parties, including with President Bazoum, continues in Niger.

VOA: Have you spoken to your colleague [Nigerien] Ambassador [Yaou] Bakary here? Because I know today the military has fired some ambassadors, including the ambassador to Washington.

Thomas-Greenfield: I have been in touch with him. I spoke to him early on, when the situation started, and I’ve stayed in contact with him. I’ve also spoken with President Bazoum.

VOA: And finally, Ambassador, I just wanted to ask you about Afghanistan. You’ve been very outspoken about the Taliban’s human rights record. They’ve not fulfilled many commitments to the international community. They are ignoring international calls to give women their rights, minorities, et cetera. So, is the U.S. considering any alternative approaches to encourage the Taliban to address these demands?

Thomas-Greenfield: We are continuing to put pressure on them on issues related to human rights and the rights of women. We have not recognized this government, and we have been clear that we will not recognize them until they are — until they behave in such a way to show that they deserve to be — to be recognized. So, we’re continuing to engage on this issue. We want to be clear to Afghan women and girls that we see no world where the women and girls of Afghanistan cannot be allowed to acquire education, to work, to pursue their dreams like women everywhere else in the world.

VOA: Ambassador, before I let you go, anything else you would like to touch upon?

Thomas-Greenfield: I’m looking forward to our month as president of the Security Council. We will be looking to bring before the council what is happening still in Sudan, and particularly, we have some concerns about the situation in Darfur, so you can look to the council having meetings on that in the coming days and weeks.
…

your ad here

China’s efforts to build critical infrastructure across South and Central America are setting up Chinese military forces for a potential foothold on the U.S. doorstep.

China is “in the ‘red zone,'” the commander of U.S. Southern Command said Friday, warning that many of China’s economic initiatives can easily be flipped to support a Chinese military presence.

“They are on the 20-yard line to our homeland,” SOUTHCOM General Laura Richardson told the Washington-based Center for Strategic and International Studies, using an American football analogy to illustrate how close China is to scoring on the United States.

“Or we could say they’re on the first or second island chain to our homeland,” she added.

Richardson, like other U.S. military officials, said Beijing has yet to establish an actual military base in the Western Hemisphere. But concerns have been mounting, especially following reports in June that China had upgraded an intelligence collection facility in Cuba in 2019 and could be looking to expand further. 

“There’s not a Chinese base yet,” Richardson said. “But I see with all of this critical infrastructure investment with these BRI [Belt and Road Initiative] projects that there could possibly be some [bases] someday.”

China’s embassy in Washington, however, dismissed such concerns as “lies and rumors … and slander.”

“To date, over three-quarters of countries around the world have joined this initiative, which has generated 420,000 jobs in these countries and helped more and more countries speed up economic growth,” embassy spokesperson Liu Pengyu told VOA via email.

“The BRI is well-received among the world most importantly because it is an initiative of extensive consultation, joint contribution and shared benefits,” Liu added. “China never imposes its will on other countries, nor does it slip any selfish geopolitical agenda into the initiative.”

But SOUTHCOM’s Richardson said there is a danger, pointing specifically to China’s use of dual-use technologies to build deep-water ports along key waterways such as the Panama Canal and the Strait of Magellan, which could allow Chinese officials to quickly convert the facilities from civilian to military use.

Richardson also raised concerns about the proliferation of Chinese telecommunication infrastructure in South and Central America, noting five countries have already turned to China for high-speed, 5G mobile phone networks.

She said another 24 countries rely on China for 3G or 4G mobile networks, and many are being offered “almost zero cost” upgrades that would keep them reliant on Beijing for their communication needs.

And so far, Richardson noted, the U.S. has nothing better to offer.

“We are getting outcompeted by the Chinese right now,” she said. “We have to be able to have alternative methods, alternative companies, alternative options for them [the Latin American countries] to be able to select.”

This is not the first time SOUTHCOM’s Richardson has warned about China’s inroads into Central and South America.

During an appearance earlier this year at the Washington-based Atlantic Council, she spoke of “the tentacles of the PRC” reaching across the Western Hemisphere, noting 21 of 31 Latin American countries had signed on to Beijing’s Belt and Road Initiative, with 17 welcoming Chinese investment in their deep-water ports. 

 
…

your ad here

A cyberattack disrupted hospital computer systems in several states, forcing some emergency rooms to close and ambulances to be diverted. Many primary care services remained closed Friday as security experts worked to determine the extent of the problem and resolve it.

The “data security incident” began Thursday at facilities operated by Prospect Medical Holdings, which is based in California and has hospitals and clinics there and in Texas, Connecticut, Rhode Island and Pennsylvania.

“Upon learning of this, we took our systems offline to protect them and launched an investigation with the help of third-party cybersecurity specialists,” the company said in a statement Friday. “While our investigation continues, we are focused on addressing the pressing needs of our patients as we work diligently to return to normal operations as quickly as possible.”

In Connecticut, the emergency departments at Manchester Memorial and Rockville General hospitals were closed for much of Thursday. Patients were diverted to other nearby medical centers.

“We have a national Prospect team working and evaluating the impact of the attack on all of the organizations,” Jillian Menzel, chief operating officer for the Eastern Connecticut Health Network, said in a statement.

The FBI in Connecticut issued a statement saying it is working with “law enforcement partners and the victim entities” but could not comment further on an ongoing investigation.

Elective surgeries, outpatient appointments, blood drives and other services were suspended, and while the emergency departments reopened late Thursday, many primary care services were closed on Friday, according to the Eastern Connecticut Health Network, which runs the facilities. Patients were being contacted individually, according to the network’s website.

Similar disruptions were reported at other facilities systemwide.

“Waterbury Hospital is following downtime procedures, including the use of paper records, until the situation is resolved,” spokeswoman Lauresha Xhihani said in a statement. “We are working closely with IT security experts to resolve it as quickly as possible.”

In Pennsylvania, the attack affected services at facilities including the Crozer-Chester Medical Center in Upland, Taylor Hospital in Ridley Park, Delaware County Memorial Hospital in Drexel Hill and Springfield Hospital in Springfield, according the Philadelphia Inquirer.

In California, the company has seven hospitals in Los Angeles and Orange counties, including two behavioral health facilities and a 130-bed acute care hospital in Los Angeles, according to Prospect’s website. Messages sent to representatives for these hospitals were not immediately returned.
…

your ad here

As China’s investment and trade in the Middle East and North Africa grow, young Arabs’ views of the Asian country are changing in that region, as are their views of the United States. Graham Kanwit has more on this story.
…

your ad here

Biologist Ashley Wilson carefully disentangled a bat from netting above a tree-lined river and examined the wriggling, furry mammal in her headlamp’s glow. “Another big brown,” she said with a sigh.

It was a common type, one of many Wilson and colleagues had snagged on summer nights in the southern Michigan countryside. They were looking for increasingly scarce Indiana and northern long-eared bats, which historically migrated there for birthing season, sheltering behind peeling bark of dead trees.

The scientists had yet to spot either species this year as they embarked on a netting mission.

“It’s a bad suggestion if we do not catch one. It doesn’t look good,” said Allen Kurta, an Eastern Michigan University professor who has studied bats for more than 40 years.

The two bat varieties are designated as imperiled under the Endangered Species Act, the bedrock U.S. law intended to keep animal and plant types from dying out. Enacted in 1973 amid fear for iconic creatures such as the bald eagle, grizzly bear and gray wolf, it extends legal protection to 1,683 domestic species.

More than 99% of those listed as “endangered” — on the verge of extinction — or the less severe “threatened” have survived.

“The Endangered Species Act has been very successful,” Interior Secretary Deb Haaland said in an Associated Press interview. “And I believe very strongly that we’re in a better place for it.”

Fifty years after the law took effect, environmental advocates and scientists say it’s as essential as ever. Habitat loss, pollution, climate change and disease are putting an estimated 1 million species worldwide at risk.

Yet the law has become so controversial that Congress hasn’t updated it since 1992 — and some worry it won’t last another half-century.

Conservative administrations and lawmakers have stepped up efforts to weaken it, backed by landowner and industry groups that contend the act stifles property rights and economic growth. Members of Congress try increasingly to overrule government experts on protecting individual species.

The act is “well-intentioned but entirely outdated … twisted and morphed by radical litigants into a political firefight rather than an important piece of conservation law,” said Bruce Westerman, an Arkansas Republican and chairman of the House Committee on Natural Resources, who in July announced a group of GOP lawmakers would propose changes.

Environmentalists accuse regulators of slow-walking new listings to appease critics and say Congress provides too little funding to fulfill the act’s mission.

“Its biggest challenge is it’s starving,” said Jamie Rappaport Clark, president of the advocacy group Defenders of Wildlife.

Some experts say the law’s survival depends on rebuilding bipartisan support, no easy task in polarized times.

“The Endangered Species Act is our best tool to address biodiversity loss in the United States,” Senate Environment and Public Works chairman Tom Carper said during a May floor debate over whether the northern long-eared bat should keep its protection status granted in 2022.

“And we know that biodiversity is worth preserving for many reasons, whether it be to protect human health or because of a moral imperative to be good stewards of our one and only planet.”

Despite the Delaware Democrat’s plea, the Senate voted to nullify the bat’s endangered designation after opponents said disease, not economic development, was primarily responsible for the population decline.

That’s an ominous sign, said Kurta the Michigan scientist, donning waders to slosh across the mucky river bottom for the bat netting project in mid-June.

“Its population has dropped 90% in a very short period of time,” he said. “If that doesn’t make you go on the endangered species list, what’s going to?”

Turbulent history

It’s “nothing short of astounding” how attitudes toward the law have changed, largely because few realized at first how far it would reach, said Holly Doremus, a University of California, Berkeley law professor.

Attention 50 years ago was riveted on iconic animals like the American alligator, Florida panther and California condor. Some had been pushed to the brink by habitat destruction or pollutants such as the pesticide DDT. People over-harvested other species or targeted them as nuisances.

The 1973 measure made it illegal to “harass, harm, pursue, hunt, shoot, wound, kill, trap, capture or collect” listed animals and plants or ruin their habitats.

It ordered federal agencies not to authorize or fund actions likely to jeopardize their existence, although amendments later allowed permits for limited “take” — incidental killing — resulting from otherwise legal projects.

The act cleared Congress with what in hindsight appears stunning ease: unanimous Senate approval and a 390-12 House vote. President Richard Nixon, a Republican, signed it into law.

“It was not created by a bunch of hippies,” said Rebecca Hardin, a University of Michigan environmental anthropologist. “We had a sense as a country that we had done damage and we needed to heal.”

But backlash emerged as the statute spurred regulation of oil and gas development, logging, ranching and other industries. The endangered list grew to include little-known creatures — from the frosted flatwoods salamander to the tooth cave spider — and nearly 1,000 plants.

“It’s easy to get everybody to sign on with protecting whales and grizzly bears,” Doremus said. “But people didn’t anticipate that things they wouldn’t notice, or wouldn’t think beautiful, would need protection in ways that would block some economic activity.”

An early battle involved the snail darter, a tiny Southeastern fish that delayed construction of a Tennessee dam on a river then considered its only remaining home.

The northern spotted owl’s listing as threatened in 1990 sparked years of feuding between conservationists and the timber industry over management of Pacific Northwest forestland.

Rappaport Clark, who headed the U.S. Fish and Wildlife Service under President Bill Clinton, said there were still enough GOP moderates to help Democrats fend off sweeping changes sought by hardline congressional Republicans.

“Fast-forward to today, and support has declined pretty dramatically,” she said. “The atmosphere is incredibly partisan. A slim Democratic majority in the Senate is the difference between keeping the law on life support and blowing it up.”

The Trump administration ended blanket protection for animals newly deemed threatened. It let federal authorities consider economic costs of protecting species and disregard habitat impacts from climate change.

A federal judge blocked some of Trump’s moves. The Biden administration repealed or announced plans to rewrite others.

But with a couple of Democratic defections, the Senate voted narrowly this spring to undo protections for a rare grouse known as the lesser prairie chicken as well as the northern long-eared bat. The House did likewise in July.

President Joe Biden threatened vetoes. But to wildlife advocates, the votes illustrate the act’s vulnerability — if not to repeal, then to sapping its strength through legislative, agency or court actions.

One pending bill would prohibit additional listings expected to cause “significant” economic harm. Another would remove most gray wolves and grizzly bears — subjects of decades-old legal and political struggles — from the protected list and bar courts from returning them.

“Science is supposed to be the fundamental principle of managing endangered species,” said Mike Leahy, a senior director of the National Wildlife Federation. “It’s getting increasingly overruled by politics. This is every wildlife conservationist’s worst nightmare.”

Elusive middle ground

Federal regulators are caught in a crossfire over how many species the act should protect and for how long — and how to balance that with interests of property owners and industry.

Since the law took effect, 64 of roughly 1,780 listed U.S. species have rebounded enough to be removed, while 64 have improved from endangered to threatened. Eleven have been declared extinct, a label proposed for 23 others, including the ivory-billed woodpecker.

That’s a poor showing, said Jonathan Wood, vice president of law and policy with the Property and Environment Research Center, which represents landowners.

The act was supposed to function like a hospital emergency room, providing lifesaving but short-term treatment, Wood said. Instead, it resembles perpetual hospice care for too many species.

But species typically need at least a half-century to recover and most haven’t been listed that long, said Noah Greenwald, endangered species director with the Center for Biological Diversity, an environmental group.

And they often languish a decade or more awaiting listing decisions, worsening their condition and prolonging their recovery, he said. The Fish and Wildlife Service has more than 300 under consideration.

The service “is not getting the job done,” Greenwald said. “Part is lack of funding but it’s mixed with timidity, fear of the backlash.”

Agency officials acknowledge struggling to keep up with listing proposals and strategies for restoring species. The work is complex; budgets are tight. Petitions and lawsuits abound. Congress provides millions to rescue popular animals such as Pacific salmon and steelhead trout while many species get a few thousand dollars annually.

To address the problem and mollify federal government critics, supporters of the act propose steering more conservation money to state and tribal programs. A bill to provide $1.4 billion annually cleared the House with bipartisan backing in 2022 but fell short in the Senate. Sponsors are trying again.

The Fish and Wildlife Service is using funds from Biden’s Inflation Reduction Act to improve strategies for getting species off the list sooner, Director Martha Williams told a House subcommittee in July.

It’s also seeking accommodation on another thorny issue: providing enough space where imperiled species can feed, shelter and reproduce.

The act empowers the government to identify “critical habitat” where economic development can be limited. Many early supporters believed public lands and waters — state and national parks and wildlife refuges — would meet the need, said Doremus, the California-Berkeley professor.

But now about two-thirds of listed species occupy private property. And many require permanent care. For example, removing the Kirtland’s warbler from the endangered list in 2019 was contingent on continued harvesting and replanting of Michigan jack pines where the tiny songbird nests.

Meeting the rising demand will require more deals with property owners instead of critical habitat designations, which lower property values and breed resentment, said Wood of the landowners group. Incentives could include paying owners or easing restrictions on timber cutting and other development as troubled species improve.

“You can’t police your way” to cooperation, he said.

The Fish and Wildlife Service proposed regulatory changes this year to encourage voluntary efforts, hoping they’ll keep more species healthy enough to reduce listings. But environmentalists insist voluntary action is no substitute for legally enforceable protections.

“Did the makers of DDT voluntarily stop making it? No,” said Greenwald, arguing few landowners or businesses will sacrifice profits to help the environment. “We have to have strong laws and regulations if we want to address the climate and extinction crises and leave a livable planet for future generations.”

Grim prospects

Stars and fireflies provided the only natural light on the June night after Michigan biologists Kurta and Wilson extended fine nylon mesh over smoothly flowing River Raisin, 90 minutes west of Detroit. Frogs croaked; crickets chirped. Mayflies — tasty morsels for bats — swarmed in the humid air.

Long feared by people, bats increasingly are valued for gobbling crop-destroying insects and pollinating fruit, giving U.S. agriculture a yearly $3 billion boost.

“The next time you have some tequila, thank the bat that pollinated the agave plant from which that tequila was made,” Kurta said, tinkering with an electronic device that detects bats as they swoop overhead.

Hour after hour crept by. Eight bats fluttered into the nets. The scientists took measurements, then freed them. None were the endangered species they sought.

A month later, Kurta reported that 16 nights of netting at eight sites had yielded 177 bats — but just one Indiana and no northern long-eared specimens.

“Disappointing,” he said, “but expected.”
…

your ad here

Republican lawmakers are ramping up investigations of Hunter Biden and seeking to equate the legal woes of the president’s son to those of former President Donald Trump, who is accused to trying to overturn his 2020 election defeat. VOA’s White House Bureau Chief Patsy Widakuswara has the latest.
…

your ad here