FDA Finalizes Rule Allowing Mail-Order Abortion Pills

The Food and Drug Administration on Tuesday finalized a rule change that allows women seeking abortion pills to get them through the mail, replacing a long-standing requirement that they pick up the medicine in person.

The Biden administration implemented the change last year, announcing it would no longer enforce the dispensing rule. Tuesday’s action formally updates the drug’s labeling to allow women to get a prescription via telehealth consultation with a health professional, and then receive the pills through the mail, where permitted by law.

Still, the rule change’s impact has been blunted by numerous state laws limiting abortion broadly and the pills specifically. Legal experts foresee years of court battles over access to the pills, as abortion-rights proponents bring test cases to challenge state restrictions.

For more than 20 years, the FDA labeling had limited dispensing to doctor’s offices and clinics, due to safety concerns. During the COVID-19 pandemic, the FDA temporarily suspended the in-person requirement. The agency later said a new scientific review by agency staff supported easing access, concurring with numerous medical societies that had long said the restriction wasn’t necessary.

Two drugmakers that make brand-name and generic versions of abortion pills requested the latest FDA label update. Agency rules require a company to file an application before modifying dispensing restrictions on drugs.

Danco Laboratories, which sells branded Mifeprex (mifepristone), said in a statement the change “is critically important to expanding access to medication abortion services and will provide healthcare providers” another option for prescribing the drug.

More than half of U.S. abortions are now done with pills rather than surgery, according to the Guttmacher Institute, a research group that supports abortion rights.

The FDA in 2000 approved mifepristone to terminate pregnancies of up to 10 weeks when used with a second drug, misoprostol. Mifepristone is taken first to dilate the cervix and block the progesterone hormone, which is needed to sustain a pregnancy. Misoprostol is taken 24 to 48 hours later, causing the uterus to contract and expel pregnancy tissue.

Bleeding is a common side effect, though serious complications are very rare. The FDA says more than 3.7 million U.S. women have used mifepristone since its approval.

Several FDA-mandated safety requirements remain in effect, including training requirements to certify that prescribers can provide emergency care in the case of excessive bleeding. Pharmacies that dispense the pills also need a certification.

Source: Voice Of America

Trust Issues Becoming the Norm

For decades, if not longer, intelligence agencies worldwide have worried about disinformation, whether from adversaries or their own efforts to influence others.

It was persistent, and at times pitched, though it was not often on the minds of everyday people.

In 2022, however, that seems to have changed.

“In this age of misinformation — of ‘fake news,’ conspiracy theories, Twitter trolls and deepfakes — gaslighting has emerged as a word for our time,” the Merriam-Webster English language dictionary announced in November, naming it the official word of the year.

Online searches of the word, which means “the act or practice of grossly misleading someone especially for one’s own advantage,” jumped by 1740% throughout the year, the dictionary said, noting consistent interest in the word and modern efforts at deception.

In the United States, such concerns consistently dominated the public discourse, starting with President Joe Biden’s appeal to defend democracy on the first anniversary of the January 6, 2021, attack on the U.S. Capitol.

“Are we going to be a nation that lives not by the light of the truth but in the shadow of lies?” he asked.

“We cannot allow ourselves to be that kind of nation,” Biden said. “The way forward is to recognize the truth and to live by it.”

The U.S. president’s comments came just weeks after U.S. Homeland Security officials warned of ongoing — and more volatile — efforts by foreign intelligence services and terrorist organizations to seed the country with disinformation.

And those concerns grew as Russia prepared for its invasion of Ukraine.

Russia – Ukraine

“We’re seeing Russian state media spouting off now about alleged activities in eastern Ukraine,” U.S. Defense Secretary Lloyd Austin told reporters in late January, as 100,000 Russian troops took up positions along Ukraine’s border.

“This is straight out of the Russian playbook,” Austin said of the Russian disinformation efforts. “And they’re not fooling us.”

By mid-February, senior U.S. Homeland Security officials were warning that Moscow had fine-tuned its disinformation operations, “trying to lay the blame for the Ukraine crisis and the potential escalation in that conflict at the feet of the U.S.”

Russian disinformation efforts took another turn in the days following the invasion, according to U.S. defense officials, with the Kremlin publicizing false reports about the widespread surrender of Ukrainian troops to erode Ukrainian morale and resistance.

Russian-government affiliated news outlets also sought to use the war in Ukraine to boost Moscow’s standing in Africa, amplifying accounts in late February and early March of Africans and other people of color being subjected to racism as they sought to evacuate.

Other Russian disinformation campaigns focused on claims the U.S. was running biological weapons labs in Ukraine and on efforts to undermine Western support for Ukraine by targeting countries perceived as weak links.

Countercampaigns

Russia’s disinformation efforts and influence campaigns, however, did not go unanswered.

Even before the first Russian troops crossed the border into Ukraine in February, U.S. intelligence officials made a decision to fight disinformation with evidence and facts, taking the unprecedented step to declassify assessments to share with allies and even the public.

“The work that we’ve done, and it’s not without risk as an intelligence community to declassify information, has been very effective,” CIA Director William Burns told lawmakers in early March.

“We hopefully can provide some credible voice of what is actually happening,” added U.S. Director of National Intelligence Avril Haines. “That’s both for the domestic population, but that’s also for the international audience.”

Other Western countries and allies of Ukraine followed with pushback of their own.

In early March, the European Union banned broadcasts and websites affiliated with Russian state-funded media outlets.

Ukraine also ran its own counter-disinformation efforts, targeting audiences in Russia and Belarus, hoping to sow doubts and erode support for Moscow’s invasion.

“I’m not realistic about changing their minds,” Heorhii Tykhy, with Ukraine’s Foreign Ministry, said during a virtual forum in March, though he added that overall, Kyiv was “winning this information war and winning it massively.”

U.S. domestic fears

At the same, the U.S. intelligence agencies and their Western allies were focused on Russia’s disinformation efforts surrounding Ukraine, U.S. Homeland Security efforts were focused on disinformation at home.

In June, the Department of Homeland Security (DHS) reissued a National Terrorism Advisory System (NTAS) Bulletin, citing the pervasive disinformation environment, much of it originating in the U.S., as a key concern.

“It’s really the convergence of that myth and disinformation with the current events that creates those conditions that we’re concerned about in terms of mobilization to violence,” a senior DHS official said at the time.

Some of those fears had already manifested a month earlier when 18-year-old Payton Gendron, who consumed online conspiracy theories, shot and killed 10 Black people at a grocery store in Buffalo, New York.

Other acts of violence across the U.S., such as the shooting at a gay nightclub in Colorado in November, an attack against the husband of U.S. House Speaker Nancy Pelosi and a rash of threats against religious institutions, also had links of various sorts to the online disinformation environment.

“One of the things we’ve seen with violent extremist ideologies is that they often commingle or cross over,” a second senior DHS official said this past November. “It just contributes to an environment where individuals … might grab on to those narratives in a way that motivates and animates their violent or potentially violent activity.”

U.S. elections

Some of the most targeted disinformation efforts, though, centered on the U.S. midterm elections in November.

“We are concerned malicious cyber actors could seek to spread or amplify false or exaggerated claims of compromise to election infrastructure,” a senior FBI official said in early October.

Other senior U.S. officials warned that adversaries like Russia, China and Iran would seize upon false narratives, originating in the U.S., questioning the integrity of the electoral process, and seek to amplify them.

Researchers also found evidence that Russia and China, in particular, had resurrected dormant social media accounts as part of intensified disinformation campaigns to spread doubts about the U.S. election.

And as the election neared, top U.S. officials called the threat of foreign influence operations and disinformation sparking violence a “significant concern.”

In the end, fears of potential violence never materialized into actual incidents, though U.S. officials did find themselves pushing back against domestic and largely partisan efforts to take scattered malfunctions and cast them as evidence of a larger conspiracy.

A report by the cybersecurity firm Mandiant concluded that in the end, efforts by Russia, China and Iran, some targeted specific contests but were mostly “limited to moderate in scale.”

A number of experts warn the threat of election disinformation is here to stay.

Future disinformation threats

“Narratives like the Big Lie have become systemic,” Graham Brookie, senior director of the Digital Forensic Research Lab at the Atlantic Council, said about former President Donald Trump’s disproven claims that the 2020 U.S. presidential election was stolen from him.

“[There is] not a huge amount of audience growth on that narrative, but for the audiences and communities that are engaged in and believe in that narrative, their engagement has gone up and become more hardened,” Brookie told VOA.

Some U.S. lawmakers are likewise warning the threats are not dissipating.

“After each election cycle, social media platforms like Meta often alter or roll back certain misinformation policies, because they are temporary and specific to the election season,” Democratic Representative Adam Schiff, chair of the House Intelligence Committee, and Democratic Senator Sheldon Whitehouse wrote in a letter to the social media giant December 14.

“Doing so in this current environment, in which election disinformation continuously erodes trust in the integrity of the voting process, would be a tragic mistake,” they added. “Meta must commit to strong election misinformation policies year-round, as we are still witnessing falsehoods about voting and the prior elections spreading on your platform.”

Other lawmakers are looking at social media apps from China and Russia, calling for some, such as TikTok, to be banned in the U.S.

“TikTok is digital fentanyl that’s addicting Americans, collecting troves of their data, and censoring their news,” Republican Representative Mike Gallagher said in a statement regarding a bill designed to block such apps.

“This isn’t about creative videos,” Republican Senator Marco Rubio, vice chair of the Senate Intelligence Committee said in a statement regarding TikTok.

“This is about an app that is collecting data on tens of millions of American children and adults every day. We know it’s used to manipulate feeds and influence elections,” he said. “We know it answers to the People’s Republic of China.”

Source: Voice of America

Third of world in recession this year, IMF Head warns

WASHINGTON— A third of the global economy will be in recession this year, the head of the International Monetary Fund (IMF) has warned.

Kristalina Georgieva said 2023 will be “tougher” than last year as the US, EU and China see their economies slow.

It comes as the war in Ukraine, rising prices, higher interest rates and the spread of Covid in China weigh on the global economy.

“We expect one third of the world economy to be in recession,” Georgieva said on the CBS news programme Face the Nation.

The IMF cut its outlook for global economic growth in 2023 in October, due to the war in Ukraine as well as higher interest rates as central banks around the world attempt to rein in rising prices.

Since then China has scrapped its zero Covid policy and started to reopen its economy, even as coronavirus infections have spread rapidly in the country.

Georgieva warned that China, the world’s second largest economy, will face a difficult start to 2023.

Source: NAM NEWS NETWORK

UNICEF appeals for US$2.6 billion to meet increasing children’s needs in the Middle East and North Africa [EN/AR]

AMMAN, 13 December 2022- As part of a record global appeal, UNICEF is appealing for US$2.6 billion in emergency funding to deliver lifesaving assistance to over 52.7 million children in need in the Middle East and North Africa in 2023.

“With almost half of the countries in the region living in crisis or undergoing ripple effects of conflicts and wars, children remain the most affected and in massive need of assistance,” said Adele Khodr, UNICEF Regional Director in the Middle East and North Africa. “Year after year, a dire situation gets much worse with many families becoming poorer as they face the impacts of multiple crises,” she added.

The region is home to some of the world’s longest conflicts. Almost 12 years of war in Syria left more than 6.5 million children dependent on assistance. Yemen remains the world’s worst humanitarian crisis, with almost every child in the country dependent on assistance. The compounded crisis in Lebanon, and the instability in Sudan resulted in millions of additional children living in critical conditions.

“If secured, these urgent funds will allow UNICEF to reach children impacted by conflict and humanitarian crises in a timely and relevant manner. UNICEF appreciates all donors who have been essential in making the response to children’s needs in the Middle East and North Africa possible. Timely, predictable and flexible funding are essential to contribute to the wellbeing and welfare of children in the region,” concluded Khodr.

Over the years, UNICEF has been strategic in its approach to responding to conflicts and crises in the region, focusing on not only providing immediate humanitarian assistance but also on strengthening systems, creating risk-informed programmes, and planning and preparing for emergencies.

UNICEF has been conscious of how crucial it is to include local communities and be accountable to the affected populations, collaborating with regional partners to empower young girls and boys and promote their engagement in humanitarian planning. Efforts were also focused on developing partnerships and mobilizing essential resources to ensure long-term progress and impact.

In 2022, UNICEF continued to respond to needs of children and their families across the region.

Key Highlights of UNICEF’s response in 2022 across the region:

Supported around 2.8 million children to get formal and non-formal education and provided 1.2 million children with individual learning materials.

Reached more than 338 thousand children suffering from severe acute malnutrition (SAM) with treatment.

Reached around 13.1 million people with critical water, sanitation and hygiene (WASH) supplies and access to safe water for drinking, cooking and personal hygiene.

Reached around 1.4 million households with humanitarian cash assistance.

Bought and distributed around 4.9 million doses of routine vaccines against measles, tetanus, polio, diphtheria, hepatitis B and rotavirus.

Reached more than 780 thousand children and caregivers with mental health and psychosocial support services.

Notes to editors:

The Regional Humanitarian Action for Children Fast Facts can be found here

The Humanitarian Action for Children 2023 and separate appeals for countries can be found here.

The Humanitarian Action for Children appeal for 2023 includes Iraq, Jordan, Lebanon, Libya, the State of Palestine, Sudan, Syria and the Syrian refugees in neighbouring countries, and Yemen. In addition to a regional appeal and technical support from the Regional Office in Amman to countries that don’t have a standalone HAC appeal. In total, the appeal constitutes to 25 per cent of UNICEF’s financial ask globally.

This appeal does not include the response to the Afghan refugee crisis in Iran, which is included in the regional appeal of our office in South Asia. Iran hosts nearly 3.6 million Afghans, including more than 1 million who have arrived since 2021. Children make up about 40 per cent of the new arrivals.

While Türkiye is not part of the MENA region, the appeal includes the Syrian refugees’ response in the country.

In December 2021, UNICEF appealed for US$ 2.3 billion to respond to children’s needs for 2022. The appeal was revised to a total of US$ 2.4 billion, of which, only half of the funds were received.

Source: UN Children’s Fund

Indirect effects of COVID-19 on child and adolescent mental health: an overview of systematic reviews

Leila Harrison, Bianca Carducci, Jonathan D Klein, Ahmed Bhutta

Correspondence to Dr Zulfiqar Ahmed Bhutta; zulfiqar.bhutta@aku.edu

Abstract

Introduction To control the spread of COVID-19, mitigation strategies have been implemented globally, which may have unintended harmful effects on child and adolescent mental health. This study aims to synthesise the indirect mental health impacts on children and adolescents globally due to COVID-19 mitigation strategies.

Methods We included relevant reviews from MEDLINE, Embase, PsycINFO, LILACS, CINAHL, The Cochrane Library and Web of Science until January 2022 that examined the impact of COVID-19-related lockdown and stay-at-home measures on the mental health of children and adolescents. Data extraction and quality assessments were completed independently and in duplicate by BC and LH. A Measurement Tool to Assess Systematic Reviews-2 was used to assess the methodological quality.

Results Eighteen systematic reviews, comprising 366 primary studies, found a pooled prevalence of 32% for depression (95% CI: 27 to 38, n=161 673) and 32% for anxiety (95% CI: 27 to 37, n=143 928) in children and adolescents globally following COVID-19 mitigation measures. Subgroup analyses also uncovered important differences for both depression and anxiety by World Health Organization regions with few studies from Africa and relative high burden of anxiety and depression in the Eastern Mediterranean region.

Conclusions Our findings reveal a high prevalence of depression and anxiety in children and adolescents during the COVID-19 pandemic, globally, compared with prepandemic estimates. These findings highlight the urgency for governments and policymakers to strengthen mental health systems in the COVID-19 recovery, especially in low-and middle-income countries where compounding psychological stress, access and affordability of care and discrepant reporting of mental health in this population remains a challenge. We also provide insight into how to alter mitigation strategies to reduce the unintended negative consequences for the health and well-being of children and adolescents in future pandemics.

Source: British Medical Journal