Tag: corruption

How the FDA approved an antipsychotic that failed to show a meaningful benefit but raised the risk of death

In trials, brexpiprazole failed to provide a clinically meaningful benefit and it increased mortality, but the FDA fast tracked its approval and the sponsor predicts $1bn in annual sales. Robert Whitaker investigates the first licensed antipsychotic for treating agitation in elderly patients with dementia

For years, health officials have tried to rein in the prescribing of atypical antipsychotics to elderly patients with dementia. The practice has been entirely “off label” yet widespread. The US Food and Drug Administration reports that around 60% of patients with Alzheimer’s dementia in residential care have received an off-label prescription for an antipsychotic, benzodiazepine, antidepressant, or anti-epileptic drug. After a 2005 FDA warning that cited a 60-70% increased risk of death associated with antipsychotic drug use, the US Centers for Medicare and Medicaid Services established the National Partnership to Improve Dementia Care in Nursing Homes, a public-private collaboration that sought to “reduce the use of antipsychotics” and “enhance the use of non-pharmacological approaches.”1

But a May 2023 FDA approval of the antipsychotic brexpiprazole for agitation in patients with Alzheimer’s dementia may reverse all of this. At a cost of around $1400 (£1102; €1280) a month, the manufacturers Otsuka and Lundbeck, which jointly brought the “first in class” approval to market, are forecasting an additional $1bn in annual sales of Rexulti.2

Serious questions remain, however, about the harm-benefit balance of Otsuka and Lundbeck’s drug. The drug carries a “boxed warning”—the FDA’s most serious type of warning, informing prescribers of increased mortality. And among four efficacy evaluations across the three prelicensure clinical trials, the highest efficacy observed was a 5.3 point improvement over placebo on a 174 point scale. In the two trials that assessed quality of life, no benefit for either the patient or the caregiver was demonstrated.

“The small benefits do not outweigh serious safety concerns,” said Nina Zeldes, health researcher at the consumer advocacy organisation Public Citizen, addressing the FDA’s advisory committee at its 14 April meeting before the approval.3 “Like other antipsychotics, this is a drug that can kill patients without providing a meaningful benefit.”4

Keep reading

Ramaswamy Paid Wikipedia Editor to Delete Reference to Harvard Vaccine Scientist ‘Mentor’ Days before Announcing Campaign

Days before announcing his presidential bid, Vivek Ramaswamy paid a Wikipedia editor to remove information about his close relationship with a scientist who helped pioneer mRNA vaccines, suggesting Ramaswamy believed the association with technology that was ultimately used to create the Covid-19 vaccines could be a detriment to his campaign. 

Mediaite first revealed in May that Ramaswamy had paid an editor with the screen name “Jhofferman” to make edits to his biographical details on Wikipedia. Those edits included the removal of lines about Ramaswamy’s receipt of a Paul & Daisy Soros Fellowship for New Americans in 2011 and his position on Ohio’s Covid-19 Response Team. The report revealed that the Covid work was removed by Ramaswamy’s request, while the editor deleted the fellowship information after finding it was “extraneous material.”

Now, a National Review analysis reveals the paid editor also removed references to Ramaswamy’s religion and his relationship with professor Douglas Melton.

Melton, a stem-cell chemist who was one of the pioneers of the mRNA vaccine, was previously mentioned as a “mentor” to Ramaswamy on his wikipedia page. The biotech entrepreneur-turned-presidential candidate had worked for Melton in his lab while studying biology at Harvard. 

On February 9, 2023, 12 days before Ramaswamy formally announced his entrance to the race, Jhofferman also deleted a sentence in the Wikipedia bio that indicated “Ramaswamy identifies as a Hindu.” The edit reveals the line was removed at the subject’s request.

While the Wikipedia bio currently does not contain any reference to Melton’s mentorship of Ramaswamy, shortly after Jhofferman deleted the reference to Ramaswamy’s Hindu faith, a different editor added a line noting that Ramaswamy “is a Hindu, and has stressed his belief in one God.”

A section about Ramaswamy’s presidential campaign reads: “During his campaign for the Republican presidential nomination, he sought to appeal to evangelical Christian right and Christian nationalist voters, an important part of the Republican base, some of whom were unwilling to support a non-Christian presidential candidate such as Ramaswamy (who is Hindu). In campaign stops and interviews, Ramaswamy has criticized secularism. He said that the U.S. was founded on ‘Christian values’ or ‘Judeo-Christian values’; that he shares those values; and that he believes in one God.”

National Review’s analysis of the Wikipedia edits to Ramaswamy’s page also reveal a pair of edits made in November 2022 and July 2022 were made from an IP address in Ohio, where Ramaswamy lives. 

Keep reading

Look How Google Shoos You Away From The Biden Family Biz And Other Big News

While fact-checking a Federalist article early Monday morning, I did a quick Google search for “hunter biden joe biden ‘an absolute wall.’”

It’s the language now-President Joe Biden used during the 2020 campaign to allege a separation between his vice-presidential duties and his son’s overseas work for the family business. It’s back in the news after the House Oversight Committee on Thursday asked the National Archives and Records Administration for unredacted communications containing three of Joe Biden’s vice presidential pseudonyms: Robert Peters, Robin Ware, and JRB Ware.

Google, however, apparently didn’t want me to find too much information — at least not from certain sources.

“It looks like the results below are changing quickly. If this topic is new, it can sometimes take time for reliable sources to publish information,” Google alerted me, prompting me to make sure the source is “trusted on this topic” and maybe just to “come back later.”

Keep reading

Secret Letter to CDC: Top Epidemiologist Suggests Agency Misrepresented Scientific Data to Support Mask Narrative

Documents recently obtained from the National Institutes of Health suggest public health officials used inaccurate information and misrepresented medical research to advance their policy objective that masks prevent severe COVID-19 and virus transmission—despite opposing scientific evidence received from experts.

In a recently obtained letter (pdf) sent in November 2021 to the Centers for Disease Control and Prevention (CDC), top epidemiologist Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, and seven colleagues informed the agency it was promoting flawed data and excluding data that did not reinforce their narrative.

The letter warned the agency that misrepresenting data on trusted websites such as the CDC and the COVID-19 Real-Time Learning Network—jointly created by the CDC and Infectious Diseases Society of America (IDSA)—would “damage the credibility of science,” endanger public trust by “misrepresenting the evidence,” and give the public “false expectations” masking would protect them from the SARS-CoV-2 virus that causes COVID-19.

“We believe the information and recommendations as provided may actually put an individual at increased risk of becoming infected with SARS-CoV-2 and for them to experience a serious or even life-threatening infection,” Mr. Osterhom wrote.

The authors urged the IDSA to remove the suggestion that masking prevents severe disease from its website and asked the CDC to reconsider its statements about the “efficacy of masks and face coverings for preventing transmission of SARS-CoV-2.”

Osterholm also noted a pattern of selectively choosing data that supported the desired narrative that masks prevent severe COVID-19 disease and transmission—claims he said are unsupported by the scientific evidence provided by the CDC and IDSA on their websites.

Keep reading

Before investigating Hunter Biden, prosecutor worked with brother Beau

When Delaware’s acting U.S. attorney David C. Weiss celebrated a fraud conviction in 2010, he was joined by a key partner in the case: Beau Biden, the state’s attorney general.

Weiss worked with Joe Biden’s eldest son to hash out prosecution strategies. “We will continue to aggressively pursue all types of fraud in order to protect the public,” Weiss said in his part of a statement with Beau Biden on the fraud case.

Today, that little-known history highlights the deep challenges Weiss faces as he pursues a newly recharged investigation into Beau’s brother, Hunter Biden, in a small state long politically dominated by their father.

Although Democrats point to Weiss’s appointment by President Donald Trump as evidence of his independence, the full story of his career is more nuanced, as he spent two years as acting U.S. attorney under President Barack Obama and Vice President Joe Biden and then remained as a top deputy for the remainder of their term.

Weiss, who was named special counsel on Aug. 11, is now confronting blowback from formerly supportive Republicans, who accuse him of offering Hunter Biden an unfairly soft plea deal on tax and gun charges. Sen. Lindsey O. Graham (R-S.C.) summarized that view when he said on Fox News that “Mr. Weiss has been compromised.” A spokesman for House Judiciary Committee Chairman Jim Jordan (R-Ohio) said Weiss “can’t be trusted.” Whistleblowers interviewed by the GOP have also accused Weiss and the Justice Department of limiting the scope of the Hunter Biden probe, a claim Weiss has denied.

Keep reading

FBI Arrests 10 Officers In ‘Wide Ranging’ Federal Corruption Case

The Federal Bureau of Investigation (FBI) has filed charges against 10 present and former police officers from the California cities of Antioch and Pittsburg Thursday in a major federal corruption case.

“Today is a dark day in our city’s history, as people trusted to uphold the law, allegedly breached that trust and were arrested by the FBI,” Antioch Mayor Lamar Thorpe said in a statement.

The charges range from cheating on training courses to serious violations of civil rights, Mercury News reported. The focus of the allegations is mainly on Antioch Police Department (APD), which has reportedly faced complaints about excessive force and a scandal involving racist text messages.

Three officers, two currently serving and one former, are accused of committing civil rights violations, per Mercury News. The charges alleged they planned violence against specific people, kept “trophies” of their actions and lied in official reports to cover up their deeds.

Text messages exchanged between the officers reportedly reveal conversations discussing violent plans and sharing pictures of the people they targeted. In one instance, officers discussed a plan for violence, Mercury News noted.

APD Officer Devon Wenger wrote, “We need to get into something tonight bro!! Lets go 3 nights in a row dog bite.”

Later that day, APD Officer Morteza Amiri texted Wenger pictures of an injured person they allegedly pulled out of a car and threw to the ground, Mercury News reported. 

Federal officials also charged Wenger and former APD Officer Daniel Harris with possession of and conspiracy to distribute anabolic steroids, according to Mercury News. Authorities charged former APD Officer Timothy Manly Williams with obstruction for allegedly interfering with an ongoing homicide and attempted murder investigation. 

Keep reading

Delaware judge dismisses tax charges against Hunter Biden

A federal judge in Delaware dismissed tax misdemeanor charges against first son Hunter Biden on Thursday, a pro forma move weeks after a plea agreement between the Justice Department and Biden’s attorneys blew up, new filings show.

US District Judge Maryellen Noreika granted without prejudice a motion from the office of Delaware US Attorney — and newly elevated special counsel — David Weiss to withdraw its case against the 53-year-old first son after prosecutors said last Friday he would likely have to stand trial in either Washington, DC, or Southern California.

Plea talks broke down between Hunter’s legal team and federal prosecutors following a July 26 hearing, during which Noreika pressed both parties about the scope of their agreement, including potential immunity for past crimes.

Under persistent questioning from Noreika, prosecutors said such charges could include alleged violations of the Foreign Agents Registration Act — prompting Biden attorney Chris Clark to declare the deal “null and void.”

Keep reading

Government kills hundreds of Minnesota wolves to protect ranchers’ profits

It’s not easy being a wolf in northern Minnesota.

Every year dozens of the animals die of starvation, disease, parasites, vehicle traffic and poaching.

But the No. 1 killer of Minnesota wolves may come as a surprise: agents of the federal government, acting with the full force of the law.

In 2022, there were 174 documented wolf deaths in Minnesota, according to the latest state Department of Natural Resources data. Of those, 142 were killed by a relatively obscure arm of the U.S. Department of Agriculture called the Wildlife Services division.

Wildlife Services is tasked with mitigating conflicts between humans and wild animals. In Minnesota, the agency’s staffers answer complaints from ranchers who lose cattle and other livestock to wolf predation. The agency documents and verifies those complaints, and looks for non-lethal ways to protect threatened livestock, like wolf-proof fencing.

If those options don’t work, the agency traps and kills wolves deemed responsible for the loss. USDA officers kill more wolves in Minnesota than in all other states combined, according to the program’s annual reports.

That work is effectively a government handout to ranchers, who receive publicly funded protection for their privately held livestock. The ranchers also receive cash compensation from state taxpayers for their lost cattle, which in 2022 totaled $100,000 for 78 wolf predation claims, or an average of about $1,300 per claim.

While individual ranchers can experience significant losses if wolves repeatedly target their cows, the overall impact on the state’s cattle population is negligible. There are about 2.2 million cows in the state, according to USDA data. The five or six dozen documented and verified wolf kills in a given year amount to a few thousandths of 1 percent of the total population.

But the USDA’s actions in response inflict a steep toll upon Minnesota’s wolves. The 142 kills amount to fully 5% of the state’s estimated wolf population.

Keep reading

Ex-NYPD cop charged with tipping off gangbanger boyfriend about federal probe

An NYPD cop tipped off her Bronx gangbanger boyfriend about a federal probe — even giving up the name of a key witness and helping him try to dodge a murder rap, according to an indictment unsealed Wednesday.

Gina Mestre, 33, who was with the department until last year, “shamelessly” fed confidential information to the “Shooting Boys” gang after getting into “an intimate relationship” with the crew’s leader, Manhattan federal prosecutors alleged.

The disgraced officer even tipped off her alleged beau, Andrew “Caballo” Done, about a police manhunt for him following the September 2020 shooting of a rival gang member, the four-count indictment claims.

“Gina Mestre shamelessly exploited her position of public trust to assist gang members in her own NYPD precinct that were terrorizing the Bronx by committing robbery, murders, drug trafficking and other acts of violence,” US Attorney Damian Williams said in a statement.

“The indictment unsealed today alleges that the defendant abused her position as an NYPD police officer by, among other things, obstructing a federal grand jury investigation into the gang and assisting the gang’s leader in evading capture for a cold-blooded murder committed in broad daylight,” Williams said.

Mestre, of Mohegan Lake in Westchester County, joined New York’s Finest in 2013 and was assigned to the Public Safety Unit at the 52nd Precinct in the Bronx.

Keep reading

Biden Admin Sanctions Don’t Apply Again to Russian Oligarchs Who Paid Biden Family

President Joe Biden’s administration spared Hunter Biden’s Russian billionaire business associates from a sanctions list recently issued by the State Department.

Late Moscow Mayor Yuri Luzhkov’s wife, Yelena Baturina — who dined with then-Vice President Biden in April 2014 — and oligarch Vladimir Yevtushenkov — who arranged at least two meetings with Hunter Biden while his father was vice president — again escaped the crushing sanctions from the Biden administration levied on the Russian elites as a result of the Ukrainian war.

Secretary of State Antony Blinken stated Friday that the United States added four more Russian oligarchs to its sanction list. Despite their qualifications of resembling fellow Russian oligarchs, Baturina and Yevtushenkov were kept off the list.

“[T]he United States is imposing sanctions on four prominent members of Russia’s financial elite who have served on the supervisory board of the Alfa Group Consortium, one of the largest financial and investment conglomerates in Russia,” Blinken wrote:

We are also imposing sanctions on the Russian Association of Employers the Russian Union of Industrialists and Entrepreneurs (RSPP), a Russian business organization involved in the technology sector of the Russian Federation economy. The organization has promoted import substitution and convened meetings to promote responses to sanctions.

The United States will continue to take all appropriate action to hold accountable those who enable and profit from Russia’s war against Ukraine.

According to the Atlantic Council, the U.S. has more than 2,700 sanctions against Russia. Since the Ukrainian war began last year, the Biden administration imposed approximately 1,500 new and 750 amended sanctions and export controls against Russia.

Russian oligarchs Baturina and Yevtushenkov, however, are somehow immune to sanctions.

In March, they were also left off a list of sanctioned Russians, as Breitbart News reported. White House press secretary Karine Jean-Pierre declined to answer why the Biden administration refused to sanction the Russian oligarchs.

Keep reading