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Tuesday, July 2, 2024

'Scientists wary of bird flu pandemic 'unfolding in slow motion''

 Scientists tracking the spread of bird flu are increasingly concerned that gaps in surveillance may keep them several steps behind a new pandemic, according to Reuters interviews with more than a dozen leading disease experts.

Many of them have been monitoring the new subtype of H5N1 avian flu in migratory birds since 2020. But the spread of the virus to 129 dairy herds in 12 U.S. states signals a change that could bring it closer to becoming transmissible between humans. Infections also have been found in other mammals, from alpacas to house cats.

"It almost seems like a pandemic unfolding in slow motion," said Scott Hensley, a professor of microbiology at the University of Pennsylvania. "Right now, the threat is pretty low ... but that could change in a heartbeat."

The earlier the warning of a jump to humans, the sooner global health officials can take steps to protect people by launching vaccine development, wide-scale testing and containment measures.

Federal surveillance of U.S. dairy cows is currently limited to testing herds before they cross state lines. State testing efforts are inconsistent, while testing of people exposed to sick cattle is scant, government health officials and pandemic flu experts told Reuters.

"You need to know which are the positive farms, how many of the cows are positive, how well the virus spreads, how long do these cows remain infectious, the exact transmission route," said Dutch flu virologist Ron Fouchier of the Erasmus Medical Center in Rotterdam.

Dr. Jeanne Marrazzo, director of the U.S. National Institute of Allergy and Infectious Diseases, said surveillance for humans is "very, very limited."

Marrazzo described the U.S. Centers for Disease Control and Prevention’s human flu surveillance network as "really a passive reporting, passive presentation mechanism." The U.S. Department of Agriculture is more proactive in testing cows, but does not make public which farms are affected, she said.

Several experts said differing approaches from animal and human health agencies could hamper a quicker response.

“If you were designing the system from scratch, you would have one agency," said Gigi Gronvall, a biosecurity expert at the Johns Hopkins Center for Health Security. "This is not the only example where we have environmental or animal problems that cause human problems.”

A USDA spokesperson said the agency is working "around the clock" with CDC and other partners in a “whole-of-government response," adding that ongoing research shows "America’s food supply remains safe, sick cows generally recover after a few weeks, and the risk to human health remains low.”

The CDC in a statement said it, "USDA, and state and local health departments across the country have been preparing for the emergence of a novel influenza virus for nearly 2 decades and continually monitor for even the smallest changes in the virus."

'A NOTE OF CAUTION'

Some pandemics, including COVID-19, arrive with little warning. In the last flu pandemic, caused by H1N1 in 2009, the virus and its predecessors had first spread among animals for several years, Hensley said, but more surveillance would have helped health authorities prepare.

Three people in the U.S. have tested positive for H5N1 avian flu since late March after contact with cows, experiencing mild symptoms. One person in Mexico was infected with a separate H5 strain not previously seen in humans, and with no known exposure to animals. Other cases were reported in India, China and Australia, caused by different strains.

The World Health Organization says H5N1's risk to humans is low because there is no evidence of human transmission. Some tools are available if that changes, including limited amounts of existing H5N1 vaccine and antiviral medications like Tamiflu.

There are mechanisms to launch larger-scale production of tests, treatments and vaccines, if needed, said the U.N. agency's head of flu, Wenqing Zhang.

Other experts said there is sufficient concern to start preparing for potential spread in humans, although triggers for taking action differ depending on the role played in the response, said Richard Hatchett, chief executive of the Coalition for Epidemic Preparedness Innovations (CEPI). His organization acted early on funding COVID vaccine development, and is now in talks with research partners about H5N1.

CEPI aims to create a library of prototype vaccines for pathogens with pandemic potential. This would help drugmakers initiate large-scale production and distribute shots where necessary within 100 days of an outbreak.

Some countries are taking steps to protect people against H5N1. The United States and Europe are securing doses of “pre-pandemic” flu vaccine that could be used for high-risk groups, including farm or lab workers. Finland is expected to become the first country to inoculate fur and poultry farm workers, as well as animal health response workers.

Expanding vaccine access is also complex, said the WHO's Zhang. Manufacturers of potential pandemic flu vaccines make seasonal flu shots and cannot produce both at once, she said.

Since most flu vaccines are made using virus grown in eggs, it could take up to six months to produce pandemic shots. The U.S. is in talks with Moderna to use their faster mRNA technology for pandemic flu shots.

The experts all acknowledged a need to balance acting quickly to avert a threat versus overreacting.

"We want to sound a note of caution," said Wendy Barclay, a virologist at Imperial College London who also advises the UK Health Security Agency on avian flu, "without saying the world is about to end."

https://www.yahoo.com/news/analysis-scientists-wary-bird-flu-100324290.html

'Novo Nordisk, Lilly must cut prices of weight-loss drugs, Biden says'

 U.S. President Joe Biden and Senator Bernie Sanders called on Novo Nordisk and Eli Lilly to reduce the prices of their weight loss and diabetes drugs, in a jointly authored opinion piece published in USA Today on Tuesday.

Surging demand for Novo and Lilly's drugs, which have been shown to help patients lose as much as 20% of their weight on average, has propelled the drugmakers' shares to record highs, and led some experts to expect the market for those treatments to reach $150 billion by the early 2030s.

More than 40% of Americans are obese, according to the Centers for Disease Control and Prevention.

Biden and Sanders in their opinion piece for USA Today said it could cost $411 billion per year if only half of obese adults took Novo and Lilly's weight loss drugs, which is $5 billion more than Americans spent on all prescription drugs in 2022.

"If the prices of these drugs are not substantially reduced, they have the potential to bankrupt the American healthcare system," Biden and Sanders said.

"If Novo Nordisk and other pharmaceutical companies refuse to substantially lower prescription drug prices in our country and end their greed, we will do everything within our power to end it for them. Novo Nordisk must substantially reduce the price of Ozempic and Wegovy."

A month's supply of Novo's diabetes drug Ozempic carries a list price of $935.77 in the U.S., while its obesity treatment Wegovy is priced at $1,349.02 per month, according to the drugmaker's website.

Lilly's Mounjaro, a diabetes drug that is also used off-label for weight loss, costs about $1,100 per month.

Novo and Eli Lilly did not immediately respond to Reuters' requests for comment. Shares of the Danish drugmaker fell nearly 3%, while those of Lilly were down 3.2% in morning trading.

Although Biden and Sanders did not say what actions they might take, both have records of pushing drugmakers to lower their prices.

Sanders last year questioned insulin makers, including Novo and Lilly, and pharmacy benefits middlemen on their roles in keeping drug prices high, and is expected to grill Novo CEO Lars Jorgensen on the price of Ozempic and Wegovy in September.

Biden's signature Inflation Reduction Act, signed into law in 2022, aims to save $25 billion annually by 2031 by requiring drugmakers to negotiate the prices of select expensive drugs with the U.S. Centers for Medicare and Medicaid Service, which oversees Medicare.

https://www.yahoo.com/news/novo-nordisk-must-cut-prices-122350737.html

Why is France targeting Nvidia?

 Nvidia is set to be charged by the French antitrust regulator for allegedly anti-competitive practices, people with direct knowledge of the matter said, making it the first enforcer to act against the computer chip maker.

The French so-called statement of objections or charge sheet would follow dawn raids in the graphics cards sector in September last year, which sources said targeted Nvidia. The raids were the result of a broader inquiry into cloud computing.

The world's largest maker of chips used both for artificial intelligence and for computer graphics has seen demand for its chips jump following the release of the generative AI application ChatGPT, triggering regulatory scrutiny on both sides of the Atlantic.

The French authority, which publishes some but not all its statements of objections to companies, and Nvidia declined comment. The company in a regulatory filing last year said regulators in the European Union, China and France had asked for information on its graphic cards.

The European Commission is unlikely to expand its preliminary review for now, since the French authority is looking into Nvidia, other people with direct knowledge of the matter said.

The French watchdog in a report issued last Friday on competition in generative AI cited the risk of abuse by chip providers.

It voiced concerns regarding the sector's dependence on Nvidia's CUDA chip programming software, the only system that is 100% compatible with the GPUs that have become essential for accelerated computing.

It also cited unease about Nvidia’s recent investments in AI-focused cloud service providers such as CoreWeave.

Companies risk fines of as much as 10% of their global annual turnover for breaching French antitrust rules, although they can also provide concessions to stave off penalties.

The U.S. Department of Justice is taking the lead in investigating Nvidia as it divvies up Big Tech scrutiny with the Federal Trade Commission, a source familiar with the matter has told Reuters.

https://finance.yahoo.com/news/french-antitrust-regulators-preparing-nvidia-144944259.html

'Bird flu concern prompts US to award Moderna $176 million for vaccine development'

 The U.S. government has awarded $176 million to Moderna to advance development of its bird flu vaccine, the company said on Tuesday, as concerns rise over a multi-state outbreak of H5N1 virus in dairy cows and infections of three dairy workers since March.

Funds from the U.S. Biomedical Advanced Research and Development Authority will be used to complete late-stage development and testing of a pre-pandemic mRNA-based vaccine against H5N1 avian influenza, the company said in a statement.

The agreement also includes additional options to prepare and accelerate a response to future public health threats, the company said.

In March, U.S. officials reported the first outbreak of the H5N1 virus in dairy cattle, which has since infected more than 130 herds in 12 states.

Scientists are concerned that exposure to the virus in poultry and dairy operations could increase the risk that the virus will mutate and gain the ability to spread easily among people, touching off a pandemic.

The risk to the general public from bird flu remains low, and vaccination is not currently recommended for any segment of the population, Dawn O'Connell, assistant secretary for preparedness and response at the U.S. Department of Health and Human Services, said on a call with reporters.

Last year, Moderna started a safety and immunogenicity study of its bird flu vaccine called mRNA-1018 in healthy adults aged 18 and older. That study included both the H5 subtype of bird flu that is currently circulating in dairy cattle, as well as the H7 bird flu subtype.

Results of that study are expected this year and will be used to map out late-stage development plans, the company said.

Late-stage trials of the vaccine will likely begin in 2025, O'Connell said.

Moderna's vaccine uses mRNA, or messenger RNA, the technology in its COVID-19 shot.

"mRNA vaccine technology offers advantages in efficacy, speed of development and production, scalability, and reliability in addressing infectious disease outbreaks, as demonstrated during the COVID-19 pandemic," Moderna CEO Stephane Bancel said in a statement.

Manufacturing of conventional flu vaccines using cell or egg-based technology can take four to six months. It is too early to tell how many doses Moderna will be able to manufacture, said Robert Johnson, director of the medical countermeasures program at HHS, on the press call.

U.S. officials have said they were moving bulk vaccine from CSL Seqirus that closely matches the current virus into finished shots that could provide 4.8 million doses if needed.

Those doses would potentially be used to inoculate farm workers and others at risk of exposure to the virus.

Lab experiments from the U.S. Food and Drug Administration continue to confirm that pasteurization inactivates the bird flu virus in dairy products, said Don Prater, director of the agency's Center for Food Safety and Applied Nutrition.

The FDA is conducting ongoing tests of retail dairy products for traces of avian flu.

https://www.aol.com/news/us-awards-moderna-176-million-113837307.html

US Supreme Court to hear challenge to Texas age verification for online 'content'

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'Millions of paywalls impede scrutiny of OnlyFans'

 It is difficult to measure the extent of child sexual abuse images and videos on the porn-driven website OnlyFans, investigators and experts say.

The only publicly available statistics are provided by OnlyFans itself. Under federal law, U.S.-based electronic service providers – including social media platforms and porn sites – must report any suspected child abuse to the National Center for Missing & Exploited Children (NCMEC), a nonprofit designated by Congress to serve as a clearinghouse for such reports. As a UK-based company, OnlyFans isn’t legally obligated to file reports to NCMEC but says it does so voluntarily.

OnlyFans says it immediately removes any suspected child sexual abuse material it detects and makes a report to NCMEC’s CyberTipline. In 2023, the company made 347 such CyberTipline reports “out of hundreds of millions of posts,” an OnlyFans spokesperson said. “This is testament to the rigorous safety controls OnlyFans has in place.”

Much of this suspect material “does not turn out to be CSAM” – child sexual abuse material – “and/or are duplicate images or videos,” OnlyFans says on its website.

But five specialists in online child sexual abuse told Reuters the actual amount of CSAM on OnlyFans is difficult to verify independently due to the existence of individual paywalls for many of its 3.2 million creators.

“It’s not just one paywall. It’s a paywall for each and every contributor,” said Trey Amick, director of forensic consultants at Magnet Forensics Inc, a Canada-based company that supplies law enforcement agencies with tools to search for child sexual abuse material.

The information police can typically get from an account, without paying for a subscription or enlisting OnlyFans’ help, is a website address, a non-explicit photo of the creator and some text describing the account.

“Beyond that, it’s extremely difficult to acquire content that’s hosted behind the paywalls of OnlyFans,” said Amick.

Once police seek OnlyFans’ help in a case, the company provides them all the information they need, including account details, content and direct messages, the OnlyFans spokesperson said. “Police investigators do not need to subscribe to content,” she said.

The spokesperson also noted that NCMEC has “full access” to the site behind its paywalls.

NCMEC said that access began in late 2023 and was “limited” to OnlyFans accounts reported to its CyberTipline or connected to a missing child case. Beyond that, it added, NCMEC “does not proactively monitor, moderate, or actively seek to review content at scale” behind OnlyFans’ paywalls, or on any other website.

In 2021, OnlyFans appointed an “independent third party” monitor, Michael Ward, “to provide even greater transparency into our industry-leading safety measures,” its website said.

Ward, a former U.S. Justice Department prosecutor who now works at the law firm Baker Botts, was tasked with analyzing and assessing OnlyFans’ safety controls, the website said. OnlyFans didn’t respond to questions about him.

Contacted by Reuters, Ward said he couldn’t comment or confirm that he performed the role OnlyFans said he did.

https://www.yahoo.com/tech/millions-paywalls-impede-scrutiny-onlyfans-102125523.html

SCOTUS immunity ruling is what court was designed for — unpopular but constitutionally correct

 Within minutes of the Supreme Court’s decision on presidential immunity, liberal politicians and pundits seemed to move from hyperbole to hyperventilation. When not breathing into paper bags, critics predicted, again, the end of the republic.

CNN’s Van Jones declared that it was “almost a license to thug, in a way.” 

Sen. Richard Blumenthal (D-Conn.) declared: “My stomach turns with fear and anger that our democracy can be so endangered by an out-of-control court” and denounced six justices as “extreme and nakedly partisan hacks — politicians in robes.”

Blumenthal has previously shown greater intestinal fortitude, as when he threatened the justices that they would either rule as Democrats demanded or face “seismic” changes to their court.Jones warned the justices that “politically it’s bad” for them to rule this way. 

The comment captures the misguided analysis of many media outlets. The Supreme Court was designed to be unpopular; to take stands that are politically unpopular but constitutionally correct. 

Court independence

Indeed, the Democrats have become the very threat that the court was meant to resist.

Recently, senators demanded that Chief Justice John Roberts appear to answer to them for his own decisions. (Roberts wisely declined.)

Senate Majority Leader Chuck Schumer previously declared in front of the Supreme Court, “I want to tell you, [Neil] Gorsuch, I want to tell you, [Brett] Kavanaugh, you have released the whirlwind, and you will pay the price.”

Now Rep. Alexandria Ocasio-Cortez (D-NY) announced that she will seek the impeachment of all six of the conservative justices. She was immediately joined by other Democratic members.

Notably, scholars have long disagreed where to draw the line on presidential immunity. The court adopted a middle approach that rejected extreme arguments on both sides. 

Yet, because Ocasio-Cortez disagrees with their decision, she has declared that this “is an assault on American democracy. It is up to Congress to defend our nation from this authoritarian capture.”

Previously, Ocasio-Cortez admitted that she does not understand why we even have a Supreme Court. She asked “How much does the current structure benefit us? And I don’t think it does.”

Other members, such as Sen. Elizabeth Warren (D-Mass.), have called for packing the Court with additional members to immediately secure a liberal majority to rule as she desires.

For these pundits and politicians, justice is merely an extension of politics and subject to the whims of the majority. 

These are same voices who chastised Judge Aileen Cannon for “slowwalking” her decisions by holding hearings on constitutional questions. They pointed to Judge Tanya Chutkan, who supported the efforts of special counsel Jack Smith to try Trump before the election, turning her court into a rocket docket.

Chutkan quickly set aside this challenge, as well as other objections from Trump.  

Indeed, at the oral argument, Chief Justice Roberts marveled at the conclusory analysis by Patricia Ann Millett in upholding Chutkan. He referred to the opinion celebrated by the left as little more than declaring “a former president can be prosecuted because he’s being prosecuted.” Chutkan and the DC Circuit were fast but ultimately wrong. Indeed, the Supreme Court noted that the judge created little record for the basis of her decisions. 

In a perverted sense, Democrats are giving the public a powerful lesson in constitutional law. As Alexander Hamilton stated in The Federalist No. 78, judicial independence “is the best expedient which can be devised in any government to secure a steady, upright and impartial administration of the laws.”

This is the moment that the Framers envisioned in creating the Court under Article III of the Constitution. It would be our bulwark even when politicians lose faith in our Constitution and seek to dictate justice for those who they dislike.

An ‘Age of Rage’

In my new book, “The Indispensable Right: Free Speech in an Age of Rage.” I discuss other such moments in our history. This is not our first age of rage. During periods of intense fear or anger, people often turn on free speech or other rights as inconvenient or outdated.

We have heard the same voices of the faithless today. MSNBC commentator Elie Mystal has called the Constitution “trash” and argued that we should simply just dump it. Law professors Ryan D. Doerfler of Harvard and Samuel Moyn of Yale called for the Constitution to be “radically altered” to “reclaim America from constitutionalism.”

None of these threats or bloviating will work. The court is designed to stand against everyone and everything except for the Constitution. It was forged for this moment.

Jonathan Turley is the J.B. and Maurice C. Shapiro professor of public interest law at the George Washington University School of Law.

https://nypost.com/2024/07/01/opinion/supreme-courts-trump-immunity-ruling-is-what-the-body-was-meant-for-unpopular-but-constitutionally-correct/