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The Dictatorship

FDA drug approvals: Makary and Prasad say one study will be enough

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FDA drug approvals: Makary and Prasad say one study will be enough

WASHINGTON (AP) — The Food and Drug Administration plans to drop its longtime standard of requiring two rigorous studies to win approval for new drugs, the latest change from Trump administration officials vowing to speed up the availability of certain medical products.

Going forward, the FDA’s “default position” will be to require one study for new drugs and other novel health products, FDA Commissioner Dr. Marty Macary and a top deputy, Dr. Vinay Prasadwrote in a New England Journal of Medicine piece published Wednesday.

The announcement is the latest example of Makary and his team changing longstanding FDA standards and procedures with the stated goal of slashing bureaucracy and accelerating the availability of new medicines.

Since arriving at the agency last April, Makary has launched a series of directives that he says will shorten FDA reviews, including mandating the use of artificial intelligence by staffers and offering one-month drug assessments for new medications that serve “national interests.”

It contrasts with the FDA’s more restrictive approach to other products, including vaccines.

In their piece published Wednesday, Makary and Prasad state that dropping the two-trial requirement reflects modern advances that have made drug research “increasingly precise and scientific.”

“In this setting, overreliance on two trials no longer makes sense,” they write. “In 2026 there are powerful alternative ways to feel assured that our products help people live longer or better than requiring manufacturers to test them yet again.”

The FDA officials predicted the shift would lead to “a surge in drug development.”

Dr. Janet Woodcock, the FDA’s former drug director, said the change makes sense and reflects the FDA’s decades-long move toward relying on one trial, combined with supporting evidence, for various life-threatening diseases, including cancer.

“The scientific point is well taken that as we move toward greater understanding of biology and disease we don’t need to do two trials all the time,” said Woodcock, who led the FDA’s drug center for about 20 years before retiring in 2024.

The two-study standard for drugs dates to the early 1960s, when Congress passed a law requiring the FDA to review data from “adequate and well-controlled investigations,” before clearing new medications. For decades, the agency interpreted that requirement as meaning at least two studies, preferably with a large number of patients and significant follow-up time.

The reason for requiring the second study was to confirm that the first trial’s results weren’t a fluke and could be reproduced.

But beginning in the 1990s, the FDA increasingly began accepting single studies for the approval of treatments for rare or fatal diseases that companies often struggle to test in large numbers of patients.

Over the last five years, roughly 60% of first-of-a-kind drugs approved each year have been cleared based on a single study. The shift reflects laws passed by Congress that directed regulators to be more flexible when reviewing drugs for serious or hard-to-treat conditions.

Woodcock said the new policy announced Wednesday will mainly impact drugs for common diseases that previously weren’t eligible for reduced testing standards.

“It’s not the cancers and the rare diseases that will be affected by this,” she noted. “The agency has been approving those on a single trial already.”

The latest approach from FDA leadership contrasts with the agency’s recent actions on vaccines, gene therapies and other treatments.

Last week, the FDA’s vaccine division, headed by Prasad, refused to accept Moderna’s application for a new mRNA flu shot, saying its clinical trial was insufficient. Then on Wednesday the agency reversed coursesaying it would review the vaccine after Moderna agreed to conduct an additional study in older people.

Separately, Prasad has rejected a string of experimental gene therapies and biotech drugs, citing the need for additional studies or more definitive evidence. The trend has weighed on the stocks of many biotech companies and clashed with Makary’s public statements promoting the speed and flexibility of the FDA’s reviews.

Woodcock said the drug industry will have to wait and see whether the FDA’s approach to promising experimental therapies changes.

“Implementation will be everything,” she said. “Since the agency’s approach is unclear, and the industry is already baffled, I don’t think this adds any illumination.”

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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education and the Robert Wood Johnson Foundation. The AP is solely responsible for all content.

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The Dictatorship

Canadian Prime Minister Carney secures a majority government with special election wins

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Canadian Prime Minister Carney secures a majority government with special election wins

TORONTO (AP) — Canadian Prime Minister Mark Carney secured a majority government with special election wins Monday night, allowing his Liberals to pass legislation without the support of opposition parties.

Voters cast ballots for three vacant seats of the 343 districts represented in Parliament. Liberal candidate Danielle Martin won the election for the Toronto district of University Rosedale and Liberal Doly Begum won the Toronto district of Scarborough Southwest. The result for a Quebec district was expected later.

The Liberal party could stay in power until 2029 after Monday’s results.

Carney won Canada’s electionlast year fueled by public anger over U.S. President Donald Trump’s annexation threats, and he has vowed to reduce Canada’s reliance on the U.S.

Since then, five defectionsfrom opposition parties, including four from the main opposition Conservative party, put Carney’s Liberals on the cusp of the majority with 171 members of Parliament in the House of Commons.

One of those defectors referenced Carney’s speech at the World Economic Forumin Davos, Switzerland, as helping his decision. In the speech, Carney condemned economic coercion by great powers against smaller countries and received widespread praise for his remarks.

Carney, former head of the Bank of England as well as Canada’s central bank, has moved the Liberals to the center-right since replacing Justin Trudeauas prime minister in 2025.

“Congratulations to Danielle Martin, new Member of Parliament for University-Rosedale,” Carney posted on social media. “Danielle has spent her career building better public health care for Torontonians and all Canadians. Now she’s bringing her experience and determination to the House of Commons, and our country will be stronger for it.”

Daniel Béland, a political science professor at McGill University in Montreal, said the Liberals also had a shot at winning in the seat in Quebec.

Béland said the deterioration of Canada-U.S. relations under the second Trump presidency has convinced many Canadians, including people who do not identify as Liberal, to rally behind the prime minister.

“Carney has thus far proved that he is an astute politician, despite the fact that he only formally entered the political arena in January of last year,” Béland said.

“The Davos speech has certainly helped boost Carney’s support at home, and he is now significantly more popular than when he became prime minister nearly 13 months ago.”

Carney’s majority and the recent defections are another blow to Conservative leader Pierre Poilievre, who lost the previous national election last year and even his own seat in Parliament. He has since rejoined Parliament.

Poilievre won a party leadership reviewearlier this year, but continues to have problems controlling his lawmakers.

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The Dictatorship

Earth Day: Why sustainability and transparency matter more than ever

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ByKnow Your Value staff

Knowing your value starts with taking ownership of your health.

That’s why Know Your Value and its founder Mika Brzezinski  is partnering with the Environmental Working Group for an Earth Day event on April 22nd in Los Angeles.

We’re bringing together leading voices in environmental and women’s health for a conversation about knowing – and owning – our value…as women, movement creators and champions of environmental health.

Brzezinski recently spoke to Mark Abrials, chief marketing and sustainability officer – and co-founder at “Avocado green mattress” – one of our event sponsors – about the role companies play in advancing environmental and social responsibility.

“For Avocado … Earth Day is every day. I mean, Earth Day is built into our DNA ,” said Abrials. “I think it’s a time for consumers to just maybe reflect upon the products that they do bring into their house and maybe use it as an opportunity to dig deeper into how they’re made, how materials are sourced, because that has a direct impact on your own personal health, but also the health of the planet.”

You can watch the entire interview below:

Know Your Value staff

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The Dictatorship

Viktor Orbán’s loss in Hungary shows how a strongman can be defeated

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Strongman rule often appears unbeatable at the ballot box, but the defeat of Hungarian Prime Minister Viktor Orbán on Sunday shows even entrenched systems can be challenged with the right strategy.

Peter Hungariandisrupted Orbán’s 16-year tenure with the support of a broad, unlikely coalition united by three core messages: Orbán must go, corruption must end and Hungary must align with the West rather than Russia. He also emphasized national sovereignty and strict border control, defying easy ideological categorization.

Péter Magyar disrupted Orbán’s 16-year tenure with the support of a broad, unlikely coalition united by three core messages: Orbán must go, corruption must end and Hungary must align with the West rather than Russia.

Magyar, the ex-husband of Orbán’s former justice minister, drew on personal knowledge of the government’s inner workings and crafted a bold, patriotic campaign. His social media strategy centered on a relatable persona. This winning combination goes a long way toward reshaping what effective opposition can look like.

For years, the “Orbán playbook” served as a manual for capturing power through elections — and then systematically dismantling checks and balances, hollowing out independent institutions, and consolidating control over the media and business sphere. Now, Hungary’s politics may be offering a different kind of playbook: one for how to bring down a strongman. Three points are particularly notable.

Change can come from within

It is tempting to view everyone inside an illiberal system as complicit. But such systems are often most vulnerable to those who understand them intimately. After 16 years of failed opposition efforts, Magyar became an effective challenger thanks in part to his insider knowledge — rather than outsider credentials.

Consider: His rise began just two years ago with a Facebook post and a viral interview exposing corruption in the Orbán regime. A meteoric ascent followed. Magyar drew on his insider understanding of how Orbán’s government exerts control over business, education, the judiciary and the media. He named methods and perpetrators with a precision, and a sense of humor, that few outsiders could match, while sharply criticizing the opposition for its weakness and lack of political imagination. This positioning — outside the regime yet deeply familiar with it, and distinct from an ineffective opposition — created a powerful advantage, one that appealed to an electorate in search of change.

Patriotism must be contested, not conceded

This point resonated with Hungarians and could be equally resonant among many Americans. Orbán consolidated power not only through his control of institutions but also by monopolizing national identity. His long-standing strategy has been to frame patriotism as the exclusive domain of his political camp — and the left, to its detriment, largely ceded the point.

Along came  Magyar, whose surname literally means “Hungarian,” with several methods for reversing this dynamic. From the prominent use of the national flag at campaign events to his cross-country tour in a flatbed truck decorated in the tricolor, his campaign reclaimed patriotism, visually and rhetorically, as a shared national identity rather than a partisan weapon. He gave speeches urging citizens to “take back” their country “step by step, brick by brick,” making clear with both symbols and words that patriotism is not the property of any single party.

Crucially, Magyar has avoided issues that could fracture his diverse coalition. He has largely steered clear of culture-war flashpoints, including the 2025 Pride parade in Budapest, which was banned by Orbán but more widely attended than ever. By staying laser-focused on regime change, anti-corruption and Western orientation, especially toward the European Union and NATO, he has maintained a fragile but expansive alliance across urban and rural divides and across ideological lines.

Many Hungarian voters may not support Magyar  enthusiastically — but enough were eager for change that they were willing to support his campaign.

Charm matters

In a media environment where many of us pay more attention to personality than to institutions, values and factsMagyar’s energetic and athletic persona and willingness to show vulnerability at times contrasted with Orbán’s carefully curated and inherently insulated image. Social media does not simply compare ideas; it stages a continuous visual contest of bodies, lifestyles and vitality. Even Orbán’s formidable propaganda apparatus has struggled against a challenger who appeared unscripted and dynamic, which resonated as authentic.

Magyar’s ability to withstand constant propaganda attacks with a small but agile communications team, combining start-up-style social media tactics with large-scale, well-produced public events, further reinforced perceptions of him as a resilient political challenger.

Orbán’s long-standing strategy has been to frame patriotism as the exclusive domain of his political camp — and the left, to its detriment, largely ceded the point.

Even moments that would be vulnerabilities in traditional politics, such as outbursts of anger or bouts of passionate partying, ultimately contributed to his appeal as a flawed but driven figure — a Hungarian determined to bring change to his beloved country. Magyar emerged as a folk hero, set against an entrenched incumbent who appeared overweight, both politically and physically. The contest became, in part, one of masculinity; and here, too, the 45-year-old, more athletic Magyar claimed the advantage — even though 62-year-old Orbán has long cultivated an image as a sports enthusiast, especially in soccer.

As opposition movements across democracies struggle against entrenched populist leaders, Hungary’s election outcome offers cautions and insights. Success may depend less on ideological purity than on strategic adaptability. An electorate’s openness to unconventional figures, especially those who make an effective argument to reclaim patriotism, can allow for the construction of cross-ideological coalitions. Leaders must also project authenticity, particularly on social media. A broad, inclusive coalition united around change may be enough to upend even entrenched incumbents, leaving the harder questions of how to govern for the days that follow.

Julia Sonnevend is a sociology professor and co-director of the Center for the American Experience at The New School in New York City. She is the author of “Charm: How Magnetic Personalities Shape Global Politics.” She grew up in Budapest, Hungary.

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