Class-Action Lawsuit Filed Against Remdesivir Manufacturer Over Alleged Deceptive Practices

 by Zachary Stieber via The Epoch Times,

The company that manufactures remdesivir, used across the United States to treat COVID-19, has been hit with a class-action lawsuit over allegations it deceptively promoted the drug without disclosing possible side effects.

Two California residents, one of whom is a relative of a person who died after receiving remdesivir, lodged the suit against Gilead Sciences in Shasta County on Sept. 26.

Deborah Fust, the surviving spouse of Michael Fust, and Edward Pimentel, who says he was injured after receiving remdesivir, are accusing California-based Gilead of failing to mention documented side effects in its promotion of remdesivir.

"It's a terrible drug. The nonprofit has thousands of members who have the hospital records, and you can see there's a big difference in the creatinine levels and the blood levels, kidney readings after they get the remdesivir," Bradford Geyer, an attorney with Former Feds Group who is representing the plaintiffs, told The Epoch Times.

The FormerFedsGroup Freedom Foundation, a nonprofit, has compiled some of the cases on its website.

The suit says that Gilead's press releases and statements to consumers and investigators from Gilead show "a pattern of downplaying or omitting altogether the clinical dangers experienced by patients from remdesivir use, instead emphasizing its supposed benefits, safety, and efficacy."

For example, a website for the drug, also known as veklury, makes no mention of kidney problems. A handout (pdf) given to patients also does not mention the issues.

"Defendant's advertising that remdesivir is a safe and effective treatment for COVID-19 is false and misleading to a reasonable consumer, including plaintiffs, because defendant in fact knew or should have known, based upon prior studies and data on remdesivir, that it was unsafe and posed a high risk of severe adverse effects and death to plaintiffs and the class," the suit states.

The advertising "misrepresented and/or omitted the true content and nature of the drug," it also says.

Gilead did not respond to a request for comment.

Plaintiffs are seeking class status, which would enable two groups of people to join the suit. They are people who received remdesivir while hospitalized with COVID-19 and suffered serious injuries as a result, and people whose loved ones died after receiving remdesivir after being hospitalized with COVID-19.

Early FDA Authorization

The U.S. Food and Drug Administration (FDA) granted emergency authorization to Gilead for remdesivir in May 2020, primarily based on results from a government-sponsored trial in which researchers changed the endpoint midway. Critics said the change was done in order to garner positive results. The trial found remdesivir quickened recovery time from COVID-19.

The agency made the move without consulting its advisory committee on antimicrobial drugs.

The FDA approved remdesivir in October 2020 and expanded its allowable use to outpatient settings and children.

Soon after, a large trial run by the World Health Organization found remdesivir did not quicken recovery time or reduce mortality. The group recommended against using remdesivir in hospitalized patients, which ran counter to the recommendation in the United States.

Animal studies found indications that remdesivir injured the kidney. The U.S. trial found kidney injuries among remdesivir recipients, including in three patients who were forced to stop taking the drug.

Other studies, as well as post-approval data, have also raised safety and effectiveness concerns.

Researchers reviewing reports to VigiBase, a World Health Organization database, for instance, found reports of kidney injuries after remdesivir were far higher than reports of kidney injuries after other COVID-19 treatments.

Before receiving remdesivir, American patients are instructed (pdf) by the FDA to disclose all of their medical conditions, including kidney problems.

Gilead, while promoting remdesivir, needed to disclose the risk of kidney injuries, according to the new suit.

By not doing so, the company allegedly violated California laws against using deceptive practices and making untrue or misleading statements.

Gilead also made negligent misrepresentations, resulting in unjust enrichment, the suit says.

Plaintiffs are seeking an order establishing a class, an order preventing Gilead from engaging in "unfair, unlawful, and deceptive business practices, and false advertising," an order forcing Gilead to correct its previous advertisements, an order ordering Gilead to recall and destroy misleading and deceptive advertising materials, an order requiring Gilead to pay back money obtained by the allegedly violative actions, and an order compelling Gilead to pay restitution and interest.

Plaintiffs also want damages.

Follows Michigan Ruling

The new suit comes after a court in Michigan ruled that remdesivir was not protected under federal law against an action brought by a man who needed his leg amputated after receiving remdesivir.

The man, Don Nowacki, also suffered two strokes.

The remdesivir he received was said to be contaminated with glass particles.

Gilead argued that it could not be sued because of immunity granted by the Public Readiness and Emergency Preparedness Act, which was triggered by the Trump administration during the COVID-19 pandemic.

The judge rejected that argument, finding the act did not cover the manufacturer in the situation.

Mr. Nowacki and his lawyers are now poised to receive discovery, with a trial coming later.

"One of the things that we're going to figure out is exactly what Gilead, the FDA, and the hospital knew and when,” Ven Johnson, one of the lawyers, told The Epoch Times. “How did glass particles that could cause strokes and death in people get into this medication? Why aren’t these people approaching us to get our client’s medical records to understand what happened?”

https://www.zerohedge.com/medical/class-action-lawsuit-filed-against-remdesivir-manufacturer-over-alleged-deceptive-practices

Trump Sues Christopher Steele Over Hoax Dossier

 Former President Trump is suing Christopher Steele, the former MI-6 spook who assembled the infamous "Steele Dossier," a collection of fabricated Kremliny rumors about Donald Trump, which was funded by Hillary Clinton's 2016 campaign via a law firm intermediary, and primarily sub-sourced from a Russian analyst, Igor Danchenko - who was later found not guilty of giving false statements to the FBI.

After the former spy was commissioned by Fusion GPS, a DC-based intelligence outfit hired by the DNC and Clinton's campaign for various election-related deeds (and which employed the wife of a high-ranking DOJ official, and was accused of taking money from the Russian government, and met with the Russian Trump Tower meeting operative hours before she met Don Jr. to allegedly offer 'dirt' on Hillary Clinton's activities in Russia), the Steele Dossier was made public in January 2017 after BuzzFeed published several memos written by Steele, purporting to detail Trump's alleged "activities in Russia."

Yes, the same Russia where a Hunter Biden-linked company accepted a $3.5 million payment from the wife of the former mayor of Moscow in 2014, who Joe Biden met with according to former Hunter partner Devon Archer. And the same Russia where Bill Clinton snagged $500k for a 2010 speech & hung out with Russian President Vladimir Putin at his house, right before the Uranium One deal went down with the Hillary-run State Department (and Bill sought State's permission to meet with a Russian nuclear official).

The documents don’t indicate what decision the State Department finally made. But current and former aides to both Clintons told The Hill on Thursday the request to meet the various Russians came from other people, and the ex-president’s aides and State decided in the end not to hold any of the meetings with the Russians on the list.

Bill Clinton instead got together with Vladimir Putin at the Russian leader’s private homestead. -The Hill

Anyhow...

The Steele dossier was used by the Obama DOJ and the intelligence community to smear Trump as a Russian asset. Its various fabrications were legitimized under the guise of a legitimate DOJ investigation, and featured frequent strategic media leaks, 'expert' opinions, and manipulated evidence such as an email altered by former FBI attorney Kevin Clinesmith, which was used to renew a wiretap warrant on Trump Campaign adviser Carter Page.

Then there was the fraudulent 'Alfa Bank Server' allegation made by Clinton campaign lawyer Michael Sussman, who pleaded guilty to not telling the FBI that he was Hillary's employee when he alleged that Trump was directly communicating with the Kremlin via a covert server.

Steele peddled the dossier to the State Department - which then passed it along to former FBI deputy assistant director of counterintelligence Peter 'We'll stop Trump' Strzok. Steele also met with the DOJ's Bruce Ohr (whose wife, as we noted above, Fusion GPS employee), who he told that Russia had Trump "over a barrel."

Left to right: Nellie Ohr, Fusion GPS co-founder Glenn Simpson, Bruce Ohr

(Bruce Ohr was consequentially demoted for making "consequential errors in judgement" for failing to inform his supervisors for his role in Russiagate, and retired on Sept. of 2020 "after his counsel was informed that a final decision on a disciplinary review being conducted by Department senior career officials was imminent").

Then there was the infamous 'pee tape' allegation that Trump paid prostitutes to urinate in a bed in Moscow where Barack and Michelle Obama had stayed, and that the Kremlin had a tape of the whole thing.

The 35-page dossier was publicly disavowed by high ranking FBI officials, including the bureau's former deputy director Andrew McCabe, who told lawmakers in November 2020 that he would have never approved the Carter Page wiretap if he'd known the dossier was inaccurate.

And now, Trump is suing Steele...

According to the Independent, the 77-year-old former president is bringing a data protection claim against Steele, and his consulting firm Orbis Business Intelligence, in the UK.

"Proceedings have been issued on behalf of President Donald J. Trump against Orbis Business Intelligence Limited. The claim relates to breaches of UK Data Protection law arising from the inaccurate processing of the President’s personal data by Orbis following the publication of the false ‘Steele Dossier,’" said Trump attorney Tim Lowles.

"The President’s claim seeks remedies including that the inaccurate data contained within the Steele Dossier be erased or rectified together with the payment of damages," the statement continues.

On October 16, a two-day hearing will commence according to the report, citing a High Court order published Thursday.

Steele has defended his work, telling the Oxford Union in March 2022: "What is being called the dossier was actually a series of single-source intelligence reports over a period of time, if you like, almost a running commentary on the election campaign and Russia’s perspective on it — and it comes from the Russian perspective of the telescope if you like," adding "The sources were Russian, they were reporting on how Russia saw it, and of course, that may in some cases be rather different than how it was viewed in America at the other end of the telescope."

https://www.zerohedge.com/geopolitical/trump-sues-christopher-steele-over-hoax-dossier

Anthropology Session On Importance Of Biological Sex Canceled To Appease LGBT Advocates

 by Naveen Athrapully via The Epoch Times,

Major North American anthropology groups canceled a discussion on the importance of biological sex in anthropology, claiming that the talk harmed people identifying as LGBT.

During a joint conference between the American Anthropological Association (AAA) and the Canadian Anthropology Society (CASCA) scheduled for November in Toronto, a session titled “Let’s Talk About Sex, Baby: Why biological sex remains a necessary analytic category in Anthropology” was set to be hosted. The meeting (pdf) proposed that, while it has become “increasingly common” to substitute “sex” with “gender” in the field of anthropology, there are research domains in which biological sex is “irreplaceably relevant” to anthropological analysis.

The discussion included a panel of experts who were going to talk about “why in their work gender is not helpful and only sex will do.” The presentations aimed to discuss why “sex identification—whether an individual was male or female—using the skeleton is one of the most fundamental components in bioarchaeology and forensic anthropology.”

A Sept. 25 letter (pdf) informed about the cancelation. CASCA and AAA told panelists that the session’s ideas “were advanced in such a way as to cause harm to members represented by the Trans and LGBTQI of the anthropological community as well as the community at large.”

In a Sept. 26 open letter (pdf) to CASCA and AAA, the panelists pushed back against the decision. They argued that the panel was accepted in July after the submission was reviewed by both organizations.

“From the time of this acceptance until we received your letter dated September 25th, 2023, no one from the AAA or CASCA reached out to any of the panelists with concerns,” it said.

“Thus, it comes as a shock to all of us that the AAA and CASCA canceled the panel due to the false accusation” that the discussion would “cause harm” to LGBT people.

‘Anti-Science Response’

In their letter, the panelists asked the two organizations to share the nature of the complaints which led them to cancel the session.

“We are puzzled at the AAA / CASCA adopting as its own official stance that to support the continued use of biological sex categories (e.g., male and female; man and woman) is to imperil the safety of the LGBTQI community.”

The letter noted that the panel itself is composed of a diverse group of women, including a lesbian, and is “concerned about the erasure of women.”

For instance, an abstract from one of the panelists focuses on the issue of “counting men who identify as trans” as women in the tech industry rather than having more women in the field.

“Your suggestion that our panel would somehow compromise ‘the scientific integrity of the programme’ seems to us particularly egregious, as the decision to anathematize our panel looks very much like an anti-science response to a politicized lobbying campaign.”

The letter also raised concerns about AAA and CASCA deciding to conduct a “major review” of the processes involved in vetting sessions.

“Anthropologists around the world will quite rightly find chilling this declaration of war on dissent and on scholarly controversy. It is a profound betrayal of the AAA’s principle of ‘advancing human understanding and applying this understanding to the world’s most pressing problems,’” it said.

Sex Identification Versus Estimation

On Sept. 28, the AAA released a statement against the now-canceled discussion, accusing it of transphobia and marginalizing LGBT.

“The function of the ‘gender critical’ scholarship advocated in this session, like the function of the ‘race science’ of the late 19th and early 20th centuries, is to advance a ‘scientific’ reason to question the humanity of already marginalized groups of people, in this case, those who exist outside a strict and narrow sex/gender binary,” it insisted.

The organization accused the panel of committing a “cardinal” sin by proposing that sex and gender are “simplistically binary.”

AAA claimed that forensic anthropologists only talk about the “sex estimation” of bones and not “sex identification.”

“No single biological standard” exists according to which human beings can be grouped into the male/female binary classification, it stated.

The Epoch Times has reached out to AAA for comment.

In physical anthropology, human skeletal remains are distinguished based on whether they are male or female. This differentiation is done by examining the features and dimensions of the skeleton.

For instance, male skeletons have more cranial features and robust muscle attachment sites. Female skeletons are smaller in overall size and more gracile.

https://www.zerohedge.com/medical/anthropology-session-importance-biological-sex-canceled-appease-lgbt-advocates

Is The US Military Laying The Groundwork To Reinstitute The Draft?

 by Zachary Yost via The Mises Institute,

The most recent edition of the US Army War College’s academic journal includes a highly disturbing essay on what lessons the US military should take away from the continuing war in Ukraine.

By far the most concerning and most relevant section for the average American citizen is a subsection entitled “Casualties, Replacements, and Reconstitutions” which, to cut right to the chase, directly states, “Large-scale combat operations troop requirements may well require a reconceptualization of the 1970s and 1980s volunteer force and a move toward partial conscription.”

An Industrial War of Attrition Would Require Vast Numbers of Troops

The context for this supposed need to reinstate conscription is the estimate that were the US to enter into a large-scale conflict, every day it would likely suffer thirty-six hundred casualties and require eight hundred replacements, again per day. The report notes that over the course of twenty years in Iraq and Afghanistan, the US suffered fifty thousand casualties, a number which would likely be reached in merely two weeks of large-scale intensive combat.

The military is already facing an enormous recruiting shortfall. Last year the army alone fell short of its goal by fifteen thousand soldiers and is on track to be short an additional twenty thousand this year. On top of that, the report notes that the Individual Ready Reserve, which is composed of former service personnel who do not actively train and drill but may be called back into active service in the event they are needed, has dropped from seven hundred thousand in 1973 to seventy-six thousand now.

Prior to the Ukraine war, the fad theory in military planning was the idea of “hybrid warfare,” where the idea of giant state armies clashing on the battlefield requiring and consuming vast amounts of men and material was viewed as out of date as massed cavalry charges. Instead, these theorists argued that even when states did fight, it would be via proxies and special operations and would look more like the past twenty years of battling nonstate actors in the hills of Afghanistan. In a recent essay in the Journal of Security Studies, realist scholar Patrick Porter documents the rise of this theory and the fact that it is obviously garbage given the return of industrial wars of attrition.

As military planners have woken up from the fevered dream of imagining that modern war consisted of chasing the Taliban through the hills with complete and overwhelming airpower, they have similarly started to wake up to the idea that industrial war has vast manpower requirements and that seemingly the only way to fill these requirements is by forcing young people into the ranks. That has certainly been the only way Ukraine has been able to maintain its forces, although it has required increasingly draconian measures to do so as conscripts face attrition rates of 80 to 90 percent by Ukraine’s own admission.

Obviously, the reintroduction of conscription is an extremely disturbing prospect given America’s propensity for getting involved in meaningless wars that accomplish nothing other than empowering our enemies, killing and maiming our soldiers, and wasting vast resources.

This is especially true given the unstated assumptions implicit in this paper. Who is the enemy that would be inflicting thirty-six hundred casualties a day? A war in the Pacific against China would primarily be a naval and airpower war with an extremely limited role for the army (even the current inept regime seems unlikely to be stupid enough to try and wage a land war against China) which obviously leaves Russia as the main adversary that would require the US Army to round up conscripts to feed into the attritional meat grinder.

There Is No American National Interest That Requires a Standing Army

However, while these manpower shortages may be a valid concern for someplace like Russia, Ukraine, or Poland, we here in the US are quite fortunate that we have no compelling national interest that would require us to engage in an industrial war of attrition in Eastern Europe.

To the extent we are at risk of becoming involved in such a disastrous mess, it is entirely of our own doing via the entangling alliance known as the North Atlantic Treaty Organization and our leader’s own messianic gnostic crusades for democracy or whatever pseudo religious ideology is presently in vogue.

The US is blessed as being the most secure power in history. We are the hegemon of the western hemisphere, with vast moats in the form of the Atlantic and Pacific Oceans that no other state has the capability to project military force across, and all our neighbors are weak and relatively friendly. We are not at any risk of being forced to fight an industrial land war on the home front. Any war the army would be used in would be as an expeditionary force fighting in the eastern hemisphere, where we have no compelling defensive need to do so.

From the beginning of the US, there have been warnings against the dangers of both entangling alliances and standing armies. The best solution to the military recruitment crisis is to simply abolish the standing army and not plan to wage a costly and pointless war on the other side of the planet that would result in trillions of dollars down the drain and who knows how many tens or hundreds of thousands of Americans being killed, maimed, and psychologically scarred.

https://www.zerohedge.com/military/us-military-laying-groundwork-reinstitute-draft

IMF team to begin meeting officials in Ukraine

 An International Monetary Fund will begin holding meetings in Ukraine on Sunday to discuss policy goals and challenges with government officials and others there, the Fund's country representative Vahram Stepanyan said on Sunday.

Ukraine's economy has been hit hard since Russia launched a full-scale invasion in February 2022, and the government has relied heavily on Western aid to finance social and humanitarian payments.

The IMF said last week its mission had begun its second review of a $15.6 billion multi-year loan program for the country.

The four-year programme for Kyiv is part of a $115-billion global package to support the economy as Ukraine battles Russia's invading forces.

"An IMF team, led by Uma Ramakrishnan, Deputy Director of the Fund's European Department, starts meetings today in Kyiv with the Ukrainian authorities and other stakeholders," Stepanyan said in a statement.

"The high-level engagement will focus on policy goals and challenges in the context of Ukraine's program supported by the IMF Extended Fund Facility (EFF) Arrangement."

The government in Kyiv has said that Ukrainian businesses have adjusted to the new wartime reality and that the economy has been recovering more quickly than expected this year.

https://www.marketscreener.com/quote/currency/US-DOLLAR-RUSSIAN-ROUBL-2370597/news/IMF-team-to-begin-meeting-officials-in-Ukraine-44959923/

Babylon Bee’s fight against New York’s insane online speech law is not funny

Let’s hear it for satire: An important amicus brief has been filed on behalf of funny fake-news outlet the Babylon Bee in a crucial First Amendment case working its way through New York’s courts, with free-speech legend and UCLA prof Eugene Volokh, social video platform Rumble and creators app Locals among those filing briefs in support.  

To recap: Last year, New York state passed a nakedly unconstitutional law aimed at restricting certain kinds of online speech. 

Namely, that which tries to “vilify, humiliate, or incite violence against a group” over “race, color, religion, ethnicity, national origin, disability, sex, sexual orientation, gender identity or gender expression.”

All of which is (with narrow exceptions for incitement) 100% protected constitutionally. 

For sites that allow comments, the law threatens crushing fines that accrue by the day if they fail to post a public plan for a response if someone does a speech no-no.

The statute also demands site owners create some kind of snitch hotline for outraged readers. 

It’s a clear threat to site owners: Keep ugly speech off your platform, or the hammer comes down. 

Shellyne Rodriguez, a former Hunter College professor, was caught on video flipping out on students who were displaying anti-abortion materials.

Rutgers University

Worse still, this law was passed in response to the Buffalo supermarket massacre. 

Albany progs are using that unthinkable horror — which was not caused by speech, but by the demented evil of its perpetrator — as a lever to achieve their long-held goal of undermining First Amendment rights. 

The ways such a law can be abused are literally endless. 

Especially in a state where public employees, like ex-CUNY professor Shellyne Rodriguez, go on violent rampages against opinions they don’t like and literally threaten journalists with death. 

And that goes double since state Attorney General Tish James had made it abundantly clear she backs the censors. 

The left, in New York and elsewhere, has been on an anti-speech crusade for years, one supercharged by Trump-mania.

It’s no longer a fringe position: A recent survey showed that almost half of Democrats now support legal restrictions on speech; 75% think the state should cut down on hateful social media posts. 

Another poll showed more than half of college students think schools should use speech codes to clamp down on unfavored ideas.  

This means a victory over the law is not only crucial now; it will be ever more important in the future as this new, censorious generation gets older. 

So all good luck to the Bee, Volokh, and their fellow freedom fighters.

It’s clear they’re going to need it.  

https://nypost.com/2023/09/30/the-fight-against-new-yorks-insane-speech-law-has-never-been-more-important/

Eric Adams’ friends, advisers sure have some troubling ties

 Mayor Eric Adams’ readiness to embrace folks from every community and even make some his advisers is commendable — but there need to be limits.

The Islamist Watch’s Sam Westrop reports that a senior liaison in Hizzoner’s Community Affairs Unit, Mohammed Bahi, is also the co-founder of “a radical organization with terror ties” called Muslims Giving Back.

Bahi’s circle, he suggests, includes figures with Islamist, anti-Jewish or anti-Israel links, too.

Having people like Bahi serving on the mayor’s staff, Westrop argues, “amplifies the Islamists” — including those who detest the West.

His report follows The Post’s own revelations of Chinese Communist Party ties to one of Adams’ closest advisors, Winnie Greco.

The CCP is America’s biggest threat. Where does this end?

One of that Muslim group’s co-founders, Asad Dandi, reportedly “sympathized with Al Qaeda.”

“Through Bahi,” argues Westrop, “the Adams administration has become closely intertwined with New York Islamist networks.”

At a recent press conference, Adams was joined by Bahi and Islamists such as Talib Abdur-Rashid, of the Islamic Leadership Council of New York.

Members of the council have reportedly praised terror groups; Abdur-Rashid has “defended the Iranian regime’s call for Israel’s destruction,” says Westrop.

Adams spokesman Charles Lutvak dismisses Westrop’s report as “nonsense,” claiming much of it isn’t backed up.

Adams loves to offer people “second chances.”

Michael Brochstein/SOPA Images/Shutterstock

He notes that the group does good work, such as providing food for the poor, and we expect that’s why the mayor values its work.

Yet we checked the key claims we’re noting here.

The one about Dandi, for example, comes from a 2013 city Corporation Counsel letter, based off NYPD information. 

Meanwhile, Greco was named a consultant by at least two Beijing-backed groups.

Her company took cash from the Propaganda Department of the CCP’s Beijing Municipal Committee.

Indeed, Greco seems open about her love for the Communist Chinese regime: She once sang “Ode to the Motherland,” praising it, on stage — in front of Adams.

Yes, Adams loves to offer people “second chances,” give them the benefit of the doubt, overlook negatives.

Consider some of his hires as mayor — such as Deputy Mayor for Public Safety Philip Banks, who was named an unindicted co-conspirator in a de Blasio-era corruption case.

Or his social connections, such as to restaurateurs Johnny and Robert Petrosyants, who pleaded guilty in 2014 to financial crimes and conducted shady business practices even after, The New York Times found.

It’s been a constant in his career; decades back, he stood with the hate-spewing rabble-rouser of the Million Youth March, Khalid Muhammad, and antisemitic Nation of Islam leader Louis Farrakhan. 

Yet now Adams is mayor; shouldn’t he strive for more reputable ties?

At best, such associations don’t make for a particularly good look.

At worst, Adams is taking advice from people with questionable values.

Let’s just hope New Yorkers won’t someday pay the price.

https://nypost.com/2023/09/30/eric-adams-friends-advisers-sure-have-some-troubling-ties/