Dielli | The Sun

Albanian American Newspaper Devoted to the Intellectual and Cultural Advancement of the Albanians in America | Since 1909

New Alzheimer’s Drug Approved by FDA Modestly Slows Pace of Cognitive Decline

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Rafaela Prifti/

Today the US health officials approved a medicine meant to slow the progression of Alzheimer’s disease. The FDA accelerated approval of the new medicine known scientifically as lecanemab has drawn scrutiny given its potential wide use and its high cost of $26,500 per year for an average patient. “Leqembi is the second of a new category of medications approved for Alzheimer’s disease that target the fundamental pathophysiology of the disease” states the Press Release. In 2021, the FDA similarly cleared Aduhelm, developed through the same partnership between the Japan-based pharmaceutical company Eisai and US Biogen.

Fridays’ announcement by the FDA comes three months after a large trial findings that treatment with Leqembi slowed patients’ physical and cognitive decline over 18 months. Although the results were the first clear-cut success for a drug of Leqembi’s type in late-stage clinical testing, the accelerated approval requires companies to conduct another clinical trial before full approval can be considered. Still there are many unanswered questions about the drug with regard to the magnitude of its benefit, especially in light of its potential safety risks.

Importantly for the FDA’s decision-making, Leqembi worked as it was designed to — making it the first therapy approved in the U.S. for the treatment of Alzheimer’s itself by targeting the underlying disease process rather than symptoms of the disease.

Alzheimer is an irreversible, progressive brain disorder affecting more than 6.5 million Americans that gradually destroys memory and cognitive skills eventually affecting the ability to carry out simple tasks.

Researchers evaluated the efficacy of Leqembi in a double-blind, placebo-controlled, parallel-group, dose-finding study of 856 patients with Alzheimer’s disease, as specifies in the prescribing information. The labeling states that treatment with Leqembi should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was studied in clinical trials.

The approval of the drug, lecanemab, to be marketed as Leqembi, is likely to generate considerable interest from patients and physicians, per news reporting. In its decision, the FDA appeared to acknowledge the criticism brought on by its approval of Aduhelm in 2021 after both a committee of independent advisers and a council of senior officials at FDA pointed out that the data failed to conclusively show that Aduhelm slowed cognitive decline.

With Leqembi, the F.D.A. included narrower and more cautionary language on the drug label than it initially had with Aduhelm. The Leqembi label says the drug should be used only for patients in early and mild stages of Alzheimer’s disease, matching the status of patients in the clinical trials of the drug. Data shows that about 1.5 million of the six million people with Alzheimer’s in the United States are estimated to be in the beginning phases of the disease, with diagnoses of either mild cognitive impairment or early-stage Alzheimer’s. The number of patients to be treated with Leqembi will depend significantly on whether Medicare covers the drug.

Leqembi, the brand name, is based on “qembi” in Japanese, which “roughly translates into beautiful, healthy, elegant”. Alzheimer’s is the most common form of dementia, yet much remains unknown about this progressive neurological disorder.

Source: FDA News Release

Brief Glimpses of 2022

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Rafaela Prifti/

The emergence of the Coronavirus disease set in motion major economic and humanitarian crises testing society’s capacities to respond while generating far reaching and still evolving consequences. Nearly three years since the start of the pandemic, glimpses into the public health sector, the job market, finance and housing, war in Ukraine, climate, unions reveal the vulnerabilities of the year 2022. The pandemic has irreversibly changed Americans’ relationship with work causing widening ripple effects economically and culturally. In the financial sector, the tech stocks that flourished when Americans were staying home and were plugged in online have come back down to earth. High prices and growing interest rates have impacted the home buying market. The prices of some electric vehicle have declined. As demand ramps up, industry experts say EVs and gas-powered cars will cost about the same by 2025. As even more EVs are manufactured, they will become less expensive to produce, with some experts claiming they will be even cheaper than their gas-powered counterparts in just a few years.

Office occupancy is at less than half what it was pre-pandemic. The remote work revolution taught many office workers — and their employers — that office space wasn’t essential to work. It is a trend that is expected to last, according to researchers. On one hand the reduction of real estate space lowers the office footprint of the firms while it impacts the pay of janitorial services of union and nonunion members. Since the pandemic upended the world in 2020 the industries that have made a comeback include leisure and hospitality industry. At the end of November US hotel occupancy was at the same level it was in 2019. Despite the major changes inflicted on the restaurant industry as a result of the Covid-19 pandemic, reports indicate that, along with fast causal and quick service, dining out improved significantly this quarter. Event industry leaders are optimistic as the attendance at sporting events has bounced back to pre-pandemic levels with concert sales lagging a little behind.

The Great Resignation

Job resignation rates remain high across the board. While the fallout from the pandemic and current trends of an aging workforce continue, thecomposition of the resignations has shifted to include higher paid workers increasingly in management roles. Even as high interest rates, high-profile layoffs, and a potential recession batter the job market, Americans have continued to quit their jobs at elevated rates. Some analysts think that the tight job market is partially a factor since it supplies better opportunities. The October report by the Bureau of Labor Statistics states that there were 10.3 million job openings in the US, or 6.3 percent of employment.

Inflation, Wages Up

The Federal Reserve is the government body that adjusts federal funds with the aim of achieving conditions that satisfy its dual mandate, as set by Congress: Keep prices stable and maximize employment. Therefore, the Fed raises interest rates when the economy starts overheating, high inflation, and cuts rates when the economy looks weak, high unemployment. The feds raised the interest rates several times this year signaling more to come. While down from its peak of 9 percent in June, inflation is still high. Prices for all goods are up 7.7 percent on average nationally compared with a year earlier. While the job market keeps adding jobs and raising wages, the rise in inflation cuts into the increase in earnings. While actual wages are up about 5 per cent over year, workers end up having less buying power due to inflation.

Record high Flu season

The last week of November saw more positive flu test results than any week on record going back to 1997. According to experts, the flu has also spread earlier and at a quicker pace than it has in previous years. Part of the explanation is the increased levels of testing. Hospitalization rates are four times as high as they typically are at this time of year. But the main reason is that the population has low levels of flu antibodies since many Americans didn’t get the flu in the past two years, while adhering to preventive measures like masks and quarantining. To protect against seasonal flu, infectious disease specialist recommend vaccination and other measures, including mask-wearing, hand-washing, social-distancing and quarantining when you feel sick.

Dobbs v. Jackson

New data from the Society of Family Planning shows that the number of clinician-provided abortions in nearly half of the US has plummeted in the wake of Dobbs v. Jackson decision by the Supreme Court effectively overturning the half-century-old Roe v. Wade. Notable, the data indicates a rise in the number of procedures in states surrounding those where abortion is illegal. The jumps show up in nationwide figures. Traveling for medical care to another state involves costs that are hard to cover by people with fewer means.

Home ownership

According to data gathered from S & P Dow Jones Indices existing single-family home prices went up just 8 percent through September this year. On a monthly basis, prices have actually come down for three consecutive months yet they remain high without any clear forecast on coming down in a meaningful way. Meanwhile, rising interest rates have made buying a home even more expensive. Home ownership affordability data shows that this category is currently the worst on record. The threshold is considered to be 30 percent of income, after which housing is considered “unaffordable”.

Remote Work

A full 79 percent of Americans who can work from home are doing so, either in a hybrid or fully remote setting, according to Gallup reporting. Considering some 56 percent of full-time workers, or more than 70 million Americans, are in remote-capable jobs, that has big impacts on the future of work in and out office space.

Unions Comeback

According to data from Bloomberg Law, preliminary numbers show that more than 1,000 unions have won elections in 2022— the most since 2015. Unions are also popping up in industries previously thought ununionizable, like retail. Retail name brands like Apple, Starbucks, Amazon, Trader Joe’s, and REI all saw successful union drives this year, despite a difficult unionization process in the US. The number of strikes from nurses to rail workers so far this year was up nearly 50 percent from last year, according to data from Cornell’s ILR Labor Action Tracker. Data also shows American approval of unions is at its highest level since the 1960s, countering the decades-long decline in union membership.

Big Social Media Platforms

According to Similarweb, Facebook ranks third in a list of the most visited websites in the world following Google and YouTube. Rival social platform Twitter ranked in fourth place and Instagram, another social app owned by Facebook, ranked fifth on the list. In April, owner Elon Musk, CEO of both Tesla and SpaceX, bought Twitter, a social media company, a decision that has invited even more controversy causing concern and consternation for the consumers as well as investors.

Tech Market

As tech companies have matured, in terms of rapid growth being able to generate incredibly high profits, the revenue is still growing for most of the major companies, but not as fast as it previously did. Companies like Apple, Meta, Amazon, Alphabet, and Microsoft combined have lost more than $3 trillion in market cap this year. It has translated into hiring freezes and even mass layoffs, both moves that once were unheard of in Silicon Valley. In addition these companies have had to cut down on some of their more innovative projects. Although the big tech companies remain strong, they have shown that they are not immune from vulnerability.

Crypto

Cryptocurrencies and affiliated technologies like NFTs and Web3 were dominant in 2021 but have gone bust in 2022. Last month the spectacular fall of crypto exchange FTX caused much of the rest of the crypto industry to tumble. The collapse of FTX has been the biggest shock to crypto in years. FTX was the world’s second largest exchange, the entry point for millions of people to get into crypto. It was seen as one of the most trusted platforms, but collapsed into bankruptcy in days after its finances were revealed to be unstable. It remains to be seen if the implosion of FTX spells doom for crypto or another drop in its long-chaotic ride. Either way it reinforce the need to put in place a regulatory framework.

The War in Ukraine

The war in Ukraine began in February when Russia invaded its neighbor. Since then Europe and the US have escalated sanctions against Russia while Ukrainians continue to endure missile strikes, blackouts and loss of life. The war has also become a source of growing international tensions. The Board of Governors of the Federal Reserve System published a report stating that the global geopolitical risks have soared since Russia’s invasion of Ukraine. A direct way to measure US involvement is its military aid. While the EU and the US continue to provide support for Ukraine, the expectations by investors, market participants, and policymakers is that a prolonged war has exerted a drag on the global economy, pushed up inflation, with a sharp increase in uncertainty and risks of severe adverse outcomes.

Supply Chain

The supply chain issues have eased up this year due in part to slowing demand, which in turn caused a decrease inthe cost of goods and delivery, along with shipping time. In order to deal with international supply chain problems, the Biden administration has made efforts to crack down on high shipping industry prices and moving more manufacturing to the US.

Electric Vehicles

The most well known electric carmaker Tesla is facing a number of issues stemming from a tightening economy to increased competition. This was a big year for electric vehicles, thanks to high gas prices, more affordable models, and government investment including a revamped tax credit. EVs made up nearly 6 percent of all new vehicle registrations in the third quarter, even as the industry grappled with supply chain issues. The figure represents a minority of total auto sales, yet it is three times the rate of two years ago, and a big step toward moving Americans away from dependence on fossil fuels. As companies like Ford and GM enter the market, Tesla’s share of new electric vehicle registrations dropped from 71 percent at the start of the year to 61 percent in the third quarter of 2022, according to data from S&P Global Mobility, showing even stronger growth of sales on a global level.

A Significant Milestone In Renewable Energy

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Rafaela Prifti/

Researchers in California are a step closer to creating net energy gain, but there is still a long road ahead.

The historic announcement was made at a press conference on Tuesday by the U.S. Department of Energy. At a news conference, Jennifer Granholm, U.S. Energy Secretary said that the discovery “strengthens our national security, and ignition allows us to replicate certain conditions only found in the stars and the sun.”

According to a report in the Financial Times, this would be the first time scientists have been able to create a fusion reaction that produces more energy than it consumes, a process known as net energy gain. The team at Lawrence Livermore National Laboratory had made some progress previously in achieving fusion reaction. Since fusion occurs at very high temperatures and pressures, it is extremely difficult to control.

For decades, the United States, Russia, France and several European countries are researching methods of harnessing fusion technology.

Researchers in California produced 2.5 megajoules of energy, 120 percent of the 2.1 megajoules used to power the experiment. Despite the historic milestone, there is still a long ways to go before fusion can be viable enough to produce limitless, carbon-free energy that can power houses and businesses.

In order to do that, scientists need to design machinery that can affordably turn the nuclear reaction into sustainable electricity that can be used on the power grid. Also “building devices that are large enough to create fusion power at scale would require materials that are extraordinarily difficult to produce,” scientists say.

While advancing fusion research requires enormous resources and efforts, proponents of fusion see it as an alternative to fossil fuels and the answer to having clean, cheap, renewable energy.

EXPANSION TOP OF EU AGENDA AT TIRANA SUMMIT

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Rafaela Prifti/

The enlargement policy was a top priority at the EU and Western Balkans summit Tuesday in Tirana. It comes after officials and leaders met in June 2022 to take stock of progress on key investments under the Economic and Investment Plan for the Western Balkans as well as discuss geostrategic issues. Moldova and Ukraine became candidates for membership with Georgia soon to be added on the list. In July, the EU started membership negotiations with Albania after years of delays. While the EU has repeatedly promised Albania, Bosnia, Kosovo, Montenegro, North Macedonia and Serbia that they have futures within the organization, progress of the six nations has come to a standstill in recent years. Kosovo has signed a Stabilization and Association Agreement and reportedly would apply for candidate status later this month. The main issue for the countries-in-waiting is meeting the EU’s standards on economies and political institutions that are seen as parameters of their readiness for integration into the EU’s single market of open trade and Western democratic ideals.

With regard to the negative effects on energy and food security stemming from the Russia’s war in Ukraine, European Commission President Ursula von der Leyen announced financial support to help countries in the Western Balkans cope with shortages and higher prices. Serbian President Vucic had threatened to boycott the gathering to protest a recent political appointment by Kosova Prime Minister Albin Kurti. While Vucic has made claims of integration of Serbia into the European Union, under his leadership the country continues to not join the Western sanctions against Russia over the Ukraine war.

The newest member to join the block of 27 member nations was Croatia, also part of the Balkan region, in 2013. Since then, the enlargement process of the EU slowed as the founding member nations had no appetite to allow more countries to be integrated into the organization. After almost a decade of stagnation, the war in Ukraine has revived the issue of EU enlargement. Russia’s invasion of Ukraine has underscored the strategic importance of the region.

The Tirana declaration issued at the conclusion of the summit reaffirmed the EU’s unequivocal support for the EU perspective of the Western Balkans. “The EU reconfirms its full and unequivocal commitment to the European Union membership perspective of the Western Balkans and calls for the acceleration of the accession process, based upon credible reforms by partners, fair and rigorous conditionality and the principle of own merits.” The topics of energy crises and immigration were also the focus of discussions.

The joint summit with the six Western Balkan countries is the first being held outside the EU. It comes as the bloc fears the countries-in-waiting could start looking for possible alternatives or be influenced by China or Russia.

RECOGNIZING ALBANIAN HERITAGE AS A STEP TOWARDS MORE REPRESENTATION

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Rafaela Prifti/

Tuesday’s Albanian Heritage Reception hosted by NYC Mayor Eric Adams at Gracie Mansion wrapped up a flurry of ceremonies and commemorative celebrations, some hosted or co-hosted by City Hall, to mark the 110th Anniversary of Albania’s Independence. The presence and role of city’s elected officials was a commonality that was carried throughout the weeklong celebrating of a milestone event starting on previous Monday with the honoring of the day at the Council Chamber, followed by Sunday’s symposium and the gala dinner hosted by Vatra, and the flag raising ceremony on Bowling Green, organized by Vatra in partnership with the Mayor’s Office of Immigrant Affairs on November 28.

Coming in on the heels of several commemorations of Albania’s Independence, the Mayor’s reception nonetheless elevated further the community’s gratification for being recognized for its contributions. Ornela Beshiri, staff of Assembly Member Nathalia Fernandez, said that “It was an incredibly proud moment to witness the celebration of our country’s independence being held for the first time at the Gracie Mansion. Our history, culture and traditions were well portrayed on this historic day.”

The gratitude flowed both ways as the guest speakers thanked the community for their support including in the recent electoral campaign. In the November midterm elections, two of the guests speakers won their respective races. Assemblywoman Nathalia Fernandez was elected the next State Senator for New York and Jenifer Rajikumar scored a historic victory by becoming the first Indian American woman ever elected to a New York State Office. Assembly Member Rajikumar acknowledged the Head of her campaign Viola Isufaj as “the secret weapon” for her successful run and conveyed reverence for the great Albanian Mother Teresa whose lifework, she said, is the “embodiment of public service”.

New York City has a unique reputation in welcoming immigrants that are part of its fabric, who in turn draw upon their experiences to make the city “a place for all” as Mayor Adams put it.

Guests, businessman, diplomats from Albania’s Mission to the UN and Kosova’s General Consulate in New York, elected representative from overseas and proud Albanians as well as proud New Yorkers were handed red and black rubber wrist bands, at the entrance, bearing the inscription: Krenar Qe Jam Shqiptar Proud to be An Albanian. Mark Gjonaj, former NYC Councilman and former NYS Assembly member, a promoter of Albanian community greeted the attendees at the Gracie Mansion reception. As the MC of the evening, Gjonaj introduced the guest speakers and several Albanian officials and dignitaries including Albanian representatives and visiting members of the Montenegro Parliament. In his introduction of the NYC Mayor and the host of the event, Gjonaj touted the working relationship with Mr. Adams going back to the time they served in Albany at the New York State Assembly, continuing afterwards in New York City public service positions. In November 2021, Mr. Adams won the race to become the 110th Mayor of the City. At the Albanian Heritage reception Mayor Adams expressed gratitude for the support of the Albanian American community of the city, their contributions in all areas, along with preserving Albanian customs and culture “infused” with the American way of life. The crowd’s applause intensified when the Mayor spread both hands in front of him in a crossed motion that has come to signify the national symbol of the flying Albanian eagle.

Dr. Pashko Camaj, Executive Member of the Pan Albanian Federation of America Vatra appreciates the fact that “the event hosted at “the people’s house” gathered many Albanian organizations from the region as well as notables from abroad in a celebration of this milestone in our nations history.” In addition, he said “the event highlights many contributions and achievements of the Albanian American community to this great City.”

Integrating the cultural component as an important part of the heritage, two folk dancing groups Nora Kelmendi and Barbana were invited to perform traditional Albanian dances. The young Albanian generation of the diaspora is proud of its birth or lineage heritage while also being part of the distinct composition of backgrounds and populations that make up New York City. Dora Nano, NYU student and recipient of the National Gold Key Award from the Scholastics Art and Writing Contest said that “as an Albanian-American child of immigrants, the event felt like a symbolic gesture and honor to the diaspora that has grown here in New York. It was a pleasure to witness this nod to the diversity of our city in such a historic location as well!!” A two hundred year old building nestled in the Upper East Side neighborhood of Yorkville, Gracie Mansion is the Mayor’s official residence dubbed as the city’s “little White House” by Parks Commissioner Robert Moses.

Recognizing our heritage deserves praise but it is a step that should lead towards increasing representation of Albanians at every level of the government. According to Djellza Pulatani of Fordham College, President of United Student Government at Lincoln Center, the takeaway from the reception is about setting a higher bar. “I was deeply grateful and content that we as Albanian-Americans in New York were recognized for all of our contributions and cultivations in this city. Last night’s proceedings were a symbol of the true integration of the Albanian community here. It was a historic night that should set the foundation for the further representation of Albanians in national political spheres.”

Photo by Dora Nano