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Sunday, September 3, 2023

FDA, CDC Hid Data On Spike In COVID Cases Among The Vaccinated: Documents

by Zachary Stieber via The Epoch Times (emphasis ours),

COVID-19 cases among vaccinated seniors soared in 2021, according to newly disclosed data that was acquired by U.S. health agencies but not presented to the public.

Humetrix Cloud Services was contracted by the U.S. military to analyze vaccine data. The company performed a fresh analysis as authorities considered in 2021 whether COVID-19 vaccine boosters were necessary amid studies finding waning vaccine effectiveness.

Humetrix researchers found that the proportion of total COVID-19 cases among the seniors was increasingly comprised of vaccinated people, according to the newly disclosed documents.

For the week ending on July 31, 2021, post-vaccination COVID-19 cases represented 73 percent of the cases among people 65 and older, the company found. The elderly were 80 percent fully vaccinated at the time.

Breakthrough infection rates were higher among those who were vaccinated early, the researchers found. They estimated that the rates were twice as high in those who had been vaccinated five to six months prior, when compared to people vaccinated three to four months before.

The breakthrough cases started in January 2021, according to the data.

Protection against hospitalization was also fading, researchers discovered.

In the week ending on July 31, 2021, 63 percent of the COVID-19 hospitalizations in seniors were among the fully vaccinated, according to the documents. The same pattern of weaker protection among people who were vaccinated early was found.

Researchers calculated that the vaccine effectiveness (VE) against infection was just 33 percent while the effectiveness against hospitalization had dropped to 57 percent.

Seniors who previously had COVID-19 and recovered were more likely to avoid hospitalization, the researchers also found. Risk factors included serious underlying conditions such as obesity and being in the oldest age group, or older than 85.

The cohort analysis was completed on 20 million Medicare beneficiaries, including 5.6 million seniors who received a primary series of a COVID-19 vaccine.

"Our observational study VE findings show a very significant decrease in VE against infection and hospitalization in the Delta phase of the pandemic for individuals vaccinated with either the Pfizer or Moderna vaccine for those 5–6 months post vaccination vs. those 3–4 months post vaccination," Dr. Bettina Experton, Humetrix's president and CEO, said in a Sept. 15, 2021, email to top U.S. Food and Drug Administration (FDA) officials.

Humetrix also found that among the beneficiaries, there had been 133,000 cases, 27,000 hospitalizations, and 8,300 intensive care admissions among the fully vaccinated since the start of the COVID-19 pandemic.

Dr. Experton disclosed that Humetrix shared the data with the U.S. Centers for Disease Control and Prevention (CDC) in August 2021.

"It would have been nice to know [the military] was conducting this prior to now. Also might have been nice for CDC to share the data," Dr. Peter Marks, one of the FDA officials, told colleagues in response.

"This is more worrisome than the other data we have in my opinion," Dr. Janet Woodcock, the FDA's acting commissioner at the time, said in reply.

The presentation and emails were obtained by the Informed Consent Action Network, a nonprofit that seeks to provide transparency around medical issues, through the Freedom of Information Act (FOIA).

"It is hard to see this as anything other than a failure of our health authorities to assess, share, make public, and act upon valuable, real-world data in the midst of a so-called pandemic," Del Bigtree, founder of the network, told The Epoch Times via email. "And without FOIA, the public likely would never be made aware of these failures which, of course, allows them to be perpetrated again and again."

The FDA and CDC declined to comment.

Dr. Francis Collins, the director of the U.S. National Institutes of Health at the time, wrote in a separate email obtained through FOIA that the results of the study provided "pretty compelling evidence that VE is falling 5–6 months post vaccination for both infection and hospitalization for those over 65."

He added, "Even for those 3–4 months out there is a trend toward worsening VE.”

The CDC, FDA, and National Institutes of Health did not share the data with the public as they considered whether to clear and recommend COVID-19 vaccine boosters.

The CDC held a meeting with its vaccine advisers on Aug. 30, 2021. During the meeting, CDC officials went over emerging data on waning vaccine effectiveness. But the military study was not included.

The FDA held a similar meeting on Sept. 17, 2021. The CDC participated. The Humetrix analysis was also not presented during that meeting.

Both agencies have aggressively promoted COVID-19 vaccines throughout the pandemic, including hyping them as strongly protective against severe disease even after their own data have suggested that is not the case.

The CDC did present (pdf) data from COVID-NET, one of its systems, that showed effectiveness against COVID-19-associated hospitalization was falling among the elderly since the emergence of the Delta variant but that data still showed 80 percent effectiveness.

The presentation also included data from outside researchers and Israel that estimated the protection during the Delta era against infection ranged from 39 percent to 84 percent and that the effectiveness against hospitalization ranged from 75 to 95 percent.

The FDA ended up clearing a Pfizer booster for many Americans. The CDC advised most people to receive it. The agencies later expanded booster clearance and recommendations to virtually all Americans aged 5 and older, with Moderna's shot as another option. Authorities have since replaced the old shots due to their lack of durability, and are preparing to roll out another slate of shots this fall.

https://www.zerohedge.com/markets/fda-cdc-hid-data-spike-covid-cases-among-vaccinated-documents

Rallybio Presents Phase 1 Data on PNH Therapy

First-In-Human Single Ascending Dose Clinical Data for RLYB116 Demonstrated a Reduction in Free C5 Greater than 99% at 24 Hours for the 100 mg dose and at 12, 24, and 72 Hours for the 300 mg dose in Healthy Participants --

-- Mean Estimated Elimination Half-Life for RLYB116 was > 300 Hours --

-- No Severe or Serious Adverse Events with Single-Dose Administration of RLYB116 --

-- Phase 1 Multiple Ascending Dose Study of RLYB116 Ongoing; Preliminary Safety, PK, and PD Data Expected in 4Q 2023 --

https://finance.yahoo.com/news/rallybio-presents-phase-1-single-160000787.html

Russia signs 280,000 for contract military service this year -Medvedev

Some 280,000 people have signed up so far this year for professional service with Russia's military, the deputy chair of the Russian Security Council, former President Dmitry Medvedev, said on Sunday.

Visiting Russia's Far East, Medvedev said he was meeting local officials to work on efforts to beef up the armed forces.

"According to the Ministry of Defence, since Jan. 1, about 280,000 people have been accepted into the ranks of the Armed Forces on a contract basis," including reservists, state news agency TASS quoted Medvedev as saying.

Last year Russia announced a plan to expand its combat personnel more than 30% to 1.5 million, an ambitious task made harder by its heavy but undisclosed casualties in Moscow's war against Ukraine.

Some Russian lawmakers suggested Russia needs a professional army 7-million strong to ensure the country's security - a move that would require a huge budget allowance.

President Vladimir Putin ordered a "partial mobilisation" of 300,000 reservists in September 2022, prompting hundreds of thousands of others to flee Russia to avoid being sent to fight. Putin has said there is no need for any further mobilisation.

https://www.marketscreener.com/news/latest/Russia-signs-280-000-for-contract-military-service-this-year-Medvedev--44761842/

Texas law requiring some drunken drivers to pay child support goes into effect

Texas drunken drivers who kill a child’s parent or guardian in a crash are now liable to pay child support, according to legislation that went into effect Friday.

Texas House Bill 393, also known as Bentley’s Law, was first filed on Nov. 14 of last year. Texas Gov. Greg Abbott signed the bill on June 2.

“Any time a parent passes is tragic, but a death at the hands of a drunk driver is especially heinous,” the Republican governor wrote on X, formerly known as Twitter.

“I was proud to sign HB 393 into law this year to require offenders to pay child support for the children of their victims.”

According to the law, intoxicated manslaughter culprits are only on the hook until the child turns 18 years old or finishes high school.

“[T]he court shall determine an amount to be paid monthly for the support of the child until the child reaches 18 years of age or has graduated from high school, whichever is later,” the text reads.

The amount of child support depends on multiple factors, including the child’s educational needs, medical needs and any reasonable childcare costs. The standard of living that the child is used to is also considered.

Anyone who is unable to make payments due to incarceration may be eligible for a payment plan.

“[T]he defendant shall begin payments not later than the first anniversary of the date of the defendant’s release from the facility,” the law states.

“The defendant may enter into a payment plan to address any arrearage that exists on the date of the defendant’s release.”

Texas Governor Greg Abbott signs new law that would mandate drunken drivers who kill a child’s parent or guardian in a crash to pay child support.

https://nypost.com/2023/09/03/texas-law-requiring-some-drunken-drivers-to-pay-child-support-goes-into-effect/

Health tech news: Lawmakers call on FDA to issue stricter bone graft guidance

A bipartisan group of Michigan lawmakers sent the FDA a letter yesterday calling for stronger guidance in testing bone tissue products and screening donors. The statement comes as the CDC works to control a U.S. tuberculosis outbreak that spread via infected bone material used by dentists and orthopedic surgeons. There have been two deaths and at least 36 exposures. It’s the second tuberculosis outbreak linked to the biomaterial device company, Aziyo Biologics.

There’s no commercially available tuberculosis test for bone tissue. Even if that test existed, neither the FDA nor the American Association of Tissue Banks require companies to test their donor materials for TB.

Sens. Gary Peters and Debbie Stabenow, along with Reps. John Moolenaar and Debbie Dingell, told the FDA they had been contacted by a physician at the Michigan Medicine hospital system whose patient died of TB in August after being implanted with the material. The lawmakers urged the FDA to adopt the American Association of Tissue Banks’ recent, more stringent standards for donor screening.

“We urge the FDA to consider these recommendations and promptly

issue guidance or regulations based on sound science to protect patients and increase accountability for human tissue transplant products,” they wrote.

What’s going on at Biofourmis?

Once valued at $1.3 billion, Biofourmis appears to be in a bit of trouble. Yesterday, I reported that the company’s founder and CEO Kuldeep Singh Rajput quietly stepped down from his role without having a successor in place, just a month after his company laid off 120 people. Ben Wanamaker — formerly of Humana, Aetna, and Walmart has joined the Biofourmis board — and will oversee the company’s leadership until a new chief executive is found.

Over the years, Biofourmis has raised close to half a billion dollars and dabbled in several flavors of tech-enabled care delivery for health systems and digital support for biopharma companies. This summer, the company issued a press release bragging about all its progress over the last year, at the very same time that the layoffs were happening. Now the CEO is out — what’s going on?

A Tragic Day for American Patients

Today is a somber day for patients. The Biden administration is about to announce the first 10 drugs that will be subject to price controls under the disingenuously named Inflation Reduction Act (IRA). This misguided policy will restrict patient access to existing medicines and stifle the development of new ones.

While this year-old law's supporters frame it as a blow against Big Pharma's profits, the IRA's real victims will be everyday people. Decades of experience prove that government-imposed price controls eventually reduce incentives for innovation and inhibit patients' access to drugs. To witness the ill effects of government price-setting schemes, look no further than the multitude of drugs available to Americans that foreign bureaucrats delay or deny to patients in other countries.

The dismal equation is simple: Medicare price controls will reduce revenues for pharmaceutical companies. This, in turn, will limit their investment in new treatments. With less incentive to devote the billions of dollars required to develop new medicines, pharmaceutical companies will divert money and manpower away from high-risk research areas like Alzheimer's, cancer, and heart disease. The resulting decline in new treatments will devastate patients hoping for medical progress and loved ones seeking care and comfort for their kids, parents, grandparents, and others they cherish.

We must not forget that bringing a new drug to market requires immense investment, time, and risk. Each new medicine averages almost $3 billion in research outlays and 10 to 15 years of development in cutting-edge laboratories. This steep cost stems from both these direct expenses and the reality that only one in 10 drug candidates that enter clinical trials win FDA approval. The other nine fail. Investors wager capital on microscopic strands of unproven molecules because the profit potential of a successful drug justifies these huge rolls of the dice.

Unfortunately, price controls disrupt this risk-reward calculus. This heavy-handed government intervention undermines the chances of recouping development costs and earning any profit beyond that. This makes investing in new medicines far less attractive. With lower potential returns, revolutionary treatments for diseases like Alzheimer's and cancer will remain mirages, always just beyond the hazy horizon.

This is especially true for small-molecule drugs, since the IRA's controls can kick in just nine years after FDA approval instead of 13 for biologics. Of all the IRA's misguided policies, this may be the most glaring and worrisome. Half of a drug's lifetime revenue generally comes after its ninth year on the market. By imposing these controls, the government has made new small-molecule drugs potentially half as valuable -- a surefire way to discourage investment in new research in small-molecule treatments, which normally come in the form of easy-to-use pills rather than injections or infusions that require patients to travel to a clinic.

And the damage won't stop at the 10 drugs in the White House's immediate crosshairs. Next year, the government will select 15 additional medicines for price controls. Then another 15 the year after that. Then 20 the year after that.

By the end of the decade, virtually every top-selling medicine that isn't a recent release will be subject to price controls.

These European-style price controls ignore the vastly superior results of America's free-market system. Simply put, no other nation comes close to this country's level of biopharmaceutical innovation. The U.S. developed over half of all new medicines launched worldwide between 2011 and 2020, despite being home to just 4 percent of Earth's population.

Why undermine this successful system? America leads the world in drug development because companies enjoy financial incentives to take risks. Rather than empower Washington bureaucrats, better solutions could limit costs without jeopardizing innovation.

Eliminating barriers that generic and biosimilar versions of brand-name drugs face before they enter the market would increase competition and reduce prices. Reforming FDA regulations to accelerate approval for certain drugs also would speed less expensive medicines to patients.

Unfortunately, the Inflation Reduction Act takes the opposite approach and puts Uncle Sam firmly in command. Americans will pay for this short-sighted mistake through diseases uncured and lives unimproved. By annihilating pharmaceutical innovation, the IRA's intrusions dash all hope for our aging parents struggling with Alzheimer's, our children fighting cancer, and our friends facing debilitating diseases. Every American will suffer from slower medical progress and fewer treatment options. Washington's price controls will cast a long and dark shadow over the future of medicine and place promising therapies just around an ever-receding corner.

Peter Pitts is a former associate commissioner of the Food and Drug Administration and President of the Center for Medicine in the Public Interest.

https://townhall.com/columnists/peterpitts/2023/08/29/a-tragic-day-for-american-patients-n2627684

Biden’s Border Crisis Fuels Massive Spike In Retail Crime

As retailers reported their quarterly earnings this month, a phrase that kept cropping up is one you probably never heard before – “organized retail crime.” It has spiked enough that it’s eating into profits.

Turns out that, by throwing open the southern border, President Joe Biden has created a booming business for Mexican cartels ripping off U.S. retailers – although you’d never know it based on the media blackout of this trend.

Target, Dollar Tree, Foot Locker, Dick’s Sporting Goods, Nordstrom, and others recently disclosed that organized retail crime – or ORC for short – is hitting their bottom lines.

Dick’s Chief Financial Officer Navdeep Gupta said that the sports retailer lowered its profit outlook for the year in part because “the number of incidents and the organized retail crime impact came in significantly higher than we anticipated.”

Dollar Tree said it is keeping more of its items in locked cases or removing them altogether as organized theft climbs

Just last week, 50 criminals swarmed a Los Angeles mall and made off with $300,000 worth of stolen goods. A news report suggests that they were following orders from organized crime or gang members.

“There’s no doubt that there’s a lot of … criminal organizations behind this. Some of it involves gang members; some of it involves people that are what you would identify as professional retail thieves,” Deputy Los Angeles Police Chief Alan Hamilton told NBC News on Sunday. “It runs the gamut, and there is a black market for purchasing these items, unfortunately. … The same people [are] then turning around and committing these acts again, over and over again.”

The National Retail Federation says ORC cost retailers close to $100 billion in 2021 – a significant increase from the year before – and that money eventually comes out of consumers’ pockets.

The costs don’t end there. States are spending hundreds of millions of taxpayer dollars setting up special task forces to fight ORC. “California alone has invested more than $241.4 million over the past year bolstering law enforcement efforts to investigate and prevent organized retail theft,” reports Reuters. Then there’s also the estimated $15 billion estimated lost tax revenue.

In other words, it’s a huge problem, and getting worse.

Why the sudden explosion in organized retail crime? When it covers this issue at all, the mainstream press usually just throws up its hands, or says retailers are exaggerating the problem.

But could it have anything to do with the fact that Biden opened the border and let millions of illegal immigrants flood into the country?

Immigration and Customs Enforcement (ICE) sees a connection. In a statement released last June, it said: “Recent investigations have also identified organized retail crime schemes exploiting undocumented migrants forced to steal goods to pay back ‘coyotes’ who smuggle them across international borders.”

In another report, ICE says that:

Boosters are often undocumented immigrants, labor trafficked into the United States and working off a debt, or individuals suffering from some form of addiction. The boosters are the thieves on the ground that steal (boost) the products. They typically have a list of merchandise to steal from their crew boss and may hit numerous stores in one day. The boosters will likely be paid in cash or through anonymous/encrypted peer-to-peer payment apps.

By June of last year, the problem had grown so severe that ICE announced an effort to crack down on this migrant-fueled crime wave.

“It’s a crime that’s occurring out in our streets that’s becoming large enough where the federal government is announcing its involvement,” Thomas Welch, chief for ICE Homeland Security Investigation’s financial crimes unit in Washington, D.C., said at a news conference last year.

The connection between illegal immigrants and organized retail crime isn’t exactly new. The FBI told Congress back in 2009 about immigrants’ role, informing lawmakers that: “organized retail theft groups … utilize low-level boosters – those who actually steal the merchandise – and higher-level fencers, who frequently coordinate booster thefts. Often these boosters are illegal immigrants working off a debt or individuals suffering from some form of addiction. If these low-level boosters are removed from the criminal enterprise others will simply step in to take their place.”

Is it so hard to believe that there’s a connection between the tsunami of illegal immigrants under Biden and the rise in this form of organized crime?

Coverage of this connection has been sparse.

The Washington Examiner, one of the only outlets to cover this angle, reported this week that “Mexican cartels are behind the spike in organized retail crime and are deeply entrenched in every level of the process, according to the federal government’s chief investigative agency.”

It goes on to explain that:

These retail crimes are perpetrated by people who work as part of a crime ring run by cartels. In recent years, cartels have gone from illicit drug manufacturing and smuggling, human smuggling and trafficking, and illegal firearm smuggling to commandeering crime in the retail environment.
Cartels are involved in every level of retail crime, from in-store theft and listing items in online marketplaces to shipping stolen merchandise worldwide and using U.S. financial institutions to hold their profits.

This is a huge, hidden tax on Americans, who are paying in the form of higher prices and a loss of safety and security. It’s getting worse, courtesy of our current president.

And to its undying shame, corrupt Big Media are ignoring this story, both because it involves the border crisis they pretend doesn’t exist and because it reflects badly on Biden.

https://issuesinsights.com/2023/09/01/bidens-border-crisis-fuels-massive-spike-in-retail-crime/

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Sunday, September 3, 2023