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Is Paxlovid A Dud?

Is Paxlovid A Dud?

Authored by Maryanne Demasi via The Brownstone Institute,

Of all the antiviral drugs for Covid-19, Pfizer’s Paxlovid…

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Is Paxlovid A Dud?

Authored by Maryanne Demasi via The Brownstone Institute,

Of all the antiviral drugs for Covid-19, Pfizer’s Paxlovid has been the most successful.

Not for its safety and efficacy, but for its ability to earn the company billions in profits despite being largely ineffective for most people.

In November 2021, before any data had emerged, the Biden Administration committed to purchasing 10 million treatment courses of Paxlovid worth $5.3 billion, pending authorisation by the US drug regulator.

One month later, Paxlovid was granted emergency use authorisation (EUA) by the FDA for use in adult and paediatric populations, 12 years or older.

The authorisation was based on early trial data showing the drug could reduce hospitalisations or death (89% relative risk reduction, 6% absolute risk reduction) in high-risk patients who were unvaccinated and had no prior exposure to Covid-19.

But the problem was, most Americans by that time (Dec 2021) had already been vaccinated against Covid-19 or had prior exposure to the virus, making the trial results irrelevant to the majority of people.

Pfizer had to prove its drug could benefit a broader market. 

The manufacturer commenced the EPIC-SR trial, investigating the use of Paxlovid in unvaccinated people and vaccinated people with at least one risk factor for Covid-19 [clinicaltrials.gov].

By July 2022, however, Pfizer stopped enrolling participants “due to a very low rate of hospitalization or death observed in the standard-risk patient population.”

In a press release, the company announced that Paxlovid failed to impact its “novel primary endpoint of self-reported, sustained alleviation of all symptoms for four consecutive days.”  

In other words, Paxlovid – a combination of nirmatrelvir and ritonavir – made no significant difference in alleviating symptoms of Covid-19 compared to placebo among non-hospitalised patients.

Pfizer stated that it was difficult to find benefit in a population that was already at a low rate of hospitalisation or death from Covid-19.

One year later, in August 2023, Pfizer quietly published the unfavourable findings on clinicaltrials.gov, without any fanfare or media attention. In fact, the media continued to promote the benefits of Paxlovid to the wider public.

The New York Times, for example, ran multiple stories during the pandemic about the “Power of Paxlovid,” encouraging more people to take the drug and criticised its under-use.

Simultaneously, Pfizer stoked public fear by overinflating the risk of Covid-19, paving the way for doctors to prescribe drugs like Paxlovid to manage the disease. Sometimes, the claims were misleading.

Pfizer, for example, tweeted that 3 out of 4 American adults were at “high risk” for severe Covid-19, but then cited a study in the advertisement that did not support the claim – so far, the misleading tweet has been viewed 11.6 million times.

“This is ridiculous,” tweeted Walid Gellad, Professor of Medicine at the University of Pittsburgh, “I don’t know how it is legal…3 out of 4 adults are not at high risk of severe Covid.”

That didn’t stop FDA commissioner Robert Califf from taking to social media to promote the benefits of Paxlovid.

He tweeted the drug could reduce the risk of developing ‘long covid’ based on weak evidence, and admitted to ‘cheerleading’ the use of Paxlovid because he felt overall “the evidence was strong.”

Califf copped criticism for his lack of impartiality as the head of the regulator, but justified his actions in a “public health emergency.”

Regulatory affairs expert Jessica Adams said it was a poor excuse.

“Something is really wrong with public health ‘leadership’ if it thinks that every norm can be thrown out the window in an emergency,” said Adams. “The FDA has learned nothing during the pandemic and is setting terrible precedents for future emergencies.”

By 2023, reports of people experiencing “rebound” symptoms after using Paxlovid, were increasing. Authorities could no longer claim it was “rare.”

High-profile officials such as former CDC director Rochelle Walensky, former NIAID director Tony Fauci, President Joe Biden and First Lady Jill Biden all had reported a rebound of Covid symptoms after completing a course of Paxlovid.

Califf dismissed concerns about rebound, saying it was all just a “distraction,” but a study published in JAMA Network showed that symptomatic rebound in people with mild to moderate Covid-19 was as high as 25% after taking Paxlovid.

In May 2023, the FDA granted Paxlovid full approval for managing mild to moderate Covid-19 infections in adults at high risk of developing severe disease (including vaccinated adults, despite no data showing benefit in this population).

Last week, Paxlovid was back in the spotlight after the EPIC-SR trial was finally published in the New England Journal of Medicine, almost two years after Pfizer announced the futility of the study in July 2022.

Regardless of all the positive media coverage and promotion of Paxlovid by public health officials and government advisors, the evidence is clear.

Paxlovid, which now costs $1,400 for a 5-day course, has only shown benefit in a very rare population – that is, unvaccinated people who’ve never encountered the virus and are at high risk of serious Covid-19.

*  *  *

Republished from the author’s Substack

Tyler Durden Mon, 04/15/2024 - 19:40

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California Auditor Finds Homeless Council Can’t Account For Money Spent

California Auditor Finds Homeless Council Can’t Account For Money Spent

Authored by John Seiler via The Epoch Times,

Responsible businesses…

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California Auditor Finds Homeless Council Can't Account For Money Spent

Authored by John Seiler via The Epoch Times,

Responsible businesses do regular audits of their finances to see which areas are making money and which not.

Families also do audits, if only at tax time to see how much they owe.

Contrast that with government. California State Auditor Grant Parks just came out with a new audit, “Homelessness in California: The State Must Do More to Assess the Cost‑Effectiveness of Its Homelessness Programs.”

The Joint Legislative Committee requested the audit for homeless programs ending in 2023. Mr. Parks said the audit “focuses primarily on the State’s activities, in particular the California Interagency Council on Homelessness (Cal ICH),” which coordinates the state’s programs.

This ought to be a massive scandal.

Here’s the main conclusion.

Note there’s no definitive number given, just “billions”—and even the number of programs, “at least 30,” is fuzzy:

“More than 180,000 Californians experienced homelessness in 2023 - a 53 percent increase from 2013.

To address this ongoing crisis, nine state agencies have collectively spent billions of dollars in state funding over the past five years administering at least 30 programs dedicated to preventing and ending homelessness.

Cal ICH is responsible for coordinating, developing, and evaluating the efforts of these nine agencies.”

Below is the chart of the PIT—point in time—counts of the homeless:

(California State Auditor)

Also note the number went up 20 percent after Gov. Gavin Newsom took office in 2019, despite his Jan. 7 Inaugural Address that year pledging, “We will launch a Marshall Plan for affordable housing and lift up the fight against homelessness from a local matter to a state-wide mission.” The Marshall Plan was a 1948 U.S. aid program to restore economic growth to war-torn Europe.

‘Lack of Coordination’

Mr. Parks pointed to a Feb. 11, 2021 report by him,Homelessness in California: The State’s Uncoordinated Approach to Addressing Homelessness Has Hampered the Effectiveness of Its Efforts.”

And he said Cal ICH fulfilled a legislative requirement to report its financial assessments, but did so only for the fiscal years 2018-19 and 2020-21, not after.

He added in the new report, “Further, it has not aligned its action plan for addressing homelessness with its statutory goals, nor has it ensured that it collects accurate, complete, and comparable financial and outcome information from homelessness programs. Until Cal ICH takes these critical steps, the State will lack up‑to‑date information that it can use to make data‑driven policy decisions on how to effectively reduce homelessness.”

Basically, the state government and the citizens of California have little idea where these untold “billions” of dollars to help the homeless have gone.

3 of 5 Programs Lack Enough Data

Mr. Parks said he looked more closely at five of the “at least” 30 state homeless programs. I’ll break up his paragraphs to make it more clear: “When we selected five of the State’s homelessness programs to review, we found that two were likely cost-effective: Homekey and the CalWORKs Housing Support Program (housing support program). ...

  • “Homekey refurbishes existing buildings to provide housing units to individuals experiencing homelessness for hundreds of thousands of dollars less than the cost of newly built units.

  • “The Housing Support Program’s provision of financial support to families who were at risk of or experiencing homelessness has cost the State less than it would have spent had these families remained or become homeless.

“However, we were unable to fully assess the other three programs we reviewed ... because the State has not collected sufficient data on the programs’ outcomes. In the absence of this information, the State cannot determine whether these programs represent the best use of its funds.”

The three unassessed programs were:

  • The State Rental Assistance Program, “Provides funds for rental arrears, prospective rental payments, utility and home energy cost arrears, utility and home energy costs, and other expenses related to housing incurred during or due, directly or indirectly, to the COVID-19 pandemic.”

  • The Encampment Resolution Funding Program, “Provides competitive grants to assist local jurisdictions in ensuring the wellness and safety of people experiencing homelessness in encampments by providing services and supports that address their immediate physical and mental wellness and result in meaningful paths to safe and stable housing.”

  • The Homeless Housing, Assistance and Prevention grant program, “Provides local jurisdictions with funds to support regional coordination and expand or develop local capacity to address their immediate homelessness challenges.”

If the rest of the “at least 30” homeless programs were examined, who knows how many would end up with too little data to assess. But if the 3 to 5 ratio holds, overall of the 30 it would be 12 assessed thoroughly, 18 not properly assessed because of too little data.

Why Is Prop. 1 Money Needed?

On March 5, California voters barely passed Proposition 1, which Gov. Gavin Newsom pushed hard. The margin was 50.18 percent yea to 49.82 percent nay. As I pointed out in my analysis in the Epoch Times, officially the bonds will cost $310 million a year for 30 years to pay back, or $9.3 billion total.

The money will come from the general fund—which currently is $73 billion in deficit, according to the Legislative Analyst. Which is why for three decades I have called bonds “delayed tax increases,” because the money has to come from somewhere.

Worse, as I noted, with interest rates staying high, the true payback amount could be higher, by some estimates as high as $12.45 billion.

How can the state spend that money when it has no idea if the unaccounted “billions” currently being spent really are helping the homeless? Are the programs good, indifferent, or bad? Is the money really helping people—or just being wasted?

It’s too bad this audit wasn’t available before the March 5 vote on Prop. 1. Likewise with the late production of the Annual Comprehensive Financial Report for fiscal year 2020-22, which came out more than a year late on March 15, just after the election, and with a “net position” $29 billion worse than previously tallied.

If voters had known how bad the state finances really were, and the inability to assess current homeless programs’ finances, would they have approved Prop. 1?

Conclusion: What Really Can Be Done?

Former state Sen. John Moorlach, for whom I worked as press secretary, has been involved in helping the homeless since when he was a Certified Public Accountant in private practice in the 1980s. Later, as an Orange County Supervisor, he was the chairman of the Orange County Commission to End Homelessness.

“Newsom is throwing money everywhere,” he said. “But, really, what are you doing? What’s the program? What are the results? How do you measure? And it’s just so sad to watch.”

If current programs aren’t working, what could?

“Recently I’ve started to started to think the way you take care of you low-income housing is you’ve got to built some nice housing, and let people move up. Then the housing in the old part of town would be the low-income housing.”

He contrasted that with the current system, in which new complexes are built specifically to house the homeless. But due to government regulations, such as prevailing wage laws, “each unit costs $900,000.”

He said often the new housing is for people who don’t even want to live inside. And older housing is where the poor used to live before.

What’s certain is the current approach of “throw money at everything—and when that doesn’t work, throw more money at it,” isn’t working. Especially because, as the new audit shows, we have no idea even where most of the money is going.

Tyler Durden Mon, 04/15/2024 - 19:00

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Cheap grocery chain adds a fancy Whole Foods-style feature

The food market, which operates across the northeast and mid Atlantic, is adding a crowd pleaser.

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Routine, weekly trips to the grocery store are rapidly becoming a thing of the past. 

And that's largely because the grocery landscape is changing as a whole. 

Related: Target makes (another) self-checkout change customers will hate

Increasingly, consumer taste and demands are becoming more niche. Some prefer to shop exclusively online thanks to new delivery services like Instacart and Amazon  (AMZN)  grocery delivery. 

Others frequent superstores like Walmart  (WMT)  or Target  (TGT)  where they can hit all their errands – pharmacy, pet supplies, party favors, cosmetics, and groceries – at once. Often, these stores offer deeper discounts and better value, particularly if a customer prefers buying in bulk. 

Other customers prefer instead to make the trek to a specialty grocer, such as a Wegmans, Whole Foods, The Fresh Market, or Sprouts which tend to carry more niche, holistic, or gourmet items for even the pickiest of palates. 

Often, these specialty stores will carry an outsized number of organic produce, or items that one might have to ordinarily place a special order for ahead of time at another store or restaurant, like sushi, poke bowls, hand-made mozzarella, organic smoothies, or international candies. 

But increasingly, everyday markets and grocery stores are beginning to add in specialty conveniences in an effort to attract more customers through their doors – or please the existing ones. Florida-based Publix, for example, has been adding new features like burrito bars, fresh deli sandwich stations, salad bars, ramen bars, and freshly cooked pizzas to some of its stores for a renewed upscale experience.

Weis Markets adds unique new feature

The issue with many of these specialty stores, of course, is that only a few items can ring up a pricey bill. It's not exactly feasible for the average family of four, for example, to shop each week for their essentials at The Fresh Market. The bill would be pricey, and not every kid prefers or appreciates fresh organic burrata cheese on his or her cauliflower crust pizza for a packable lunch.

A Weis Market at Broadcasting Square.

MediaNews Group/Reading Eagle via Getty Images/Getty Images

So everyday grocery stores have been adding some more modern conveniences to their aisles in an effort to attract a clientele that appreciates the finer things but still wants to save money. 

Weis Markets announced it would be adding technologically advanced salad bars to some of its stores, which will allow customers to create their own bespoke ready to eat meals, hot and fresh, while they get their grocery shopping done. 

The salad bars are made by Picadeli of Sweden and utilize artificial intelligence to create "fresher, safer, and more craveable," salad bars using locally sourced ingredients that are typically very veggie-heavy. Red meat is not on the menu, the company proudly touts. 

"The push pre-pandemic was for more bulk foods, more service stations, [and then] the pandemic got everybody really concerned” about safety, Weis Markets Director of Produce Kevin Weaver said. “And now the pendulum is swinging back to ‘I want more choice, I want to be able to customize.’ And so service departments are making a resurgence and salad bars are making a resurgence.”

The salad bars will feature closable hoods, which will protect ingredients and keep them fresher longer. Weis Markets will start out by introducing the Picadeli stations into of their stores, many of which will be located in Maryland. 

Two stores have already received the new installations, in York and Bellefonte, Pa., and the following are slated to install them soon: 

  • Parkville, Md.
  • Perry Hall, Md.
  • Baltimore, Md.
  • Frederick, Md.
  • Huntingdon Valley, Pa.
  • Clarks Summit, Pa.

Picadeli currently operates its salad bars in other popular areas around the U.S., include Acme grocery stores, Giant, Safeway, Coborn's, and Maryville University in Missouri.

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Deborah Birx Gets Her Close-Up

Deborah Birx Gets Her Close-Up

Authored by Bill Rice via The Brownstone Institute,

Most Americans will remember Dr. Deborah Birx as the…

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Deborah Birx Gets Her Close-Up

Authored by Bill Rice via The Brownstone Institute,

Most Americans will remember Dr. Deborah Birx as the “scarf lady” who served on the White House’s Covid Response Team beginning in February 2020.

According to a recently-released (but little-seen) 24-minute mini-documentary, it was Birx – even more so than Anthony Fauci – who was responsible for government “guidelines,” almost all of which proved to be unnecessary and disastrous for the country.

According to the documentary, the guidelines ran counter to President Trump’s initial comments on Covid, but ultimately “toppled the White House (and Trump) without a shot being fired.”

The mini-documentary (“It Wasn’t Fauci: How the Deep State Really Played Trump”) was produced by Good Kid Productions. Not surprisingly, the scathing 24-minute video has received relatively few views on YouTube (only 46,500 since it was published 40 days ago on Feb. 26).

I learned of the documentary from a colleague at Brownstone Institute, who added his opinion that “Birx (is) far more culpable than Fauci in the Covid disaster…Well worth the time to see the damage an utter non-scientist, CIA-connected, bureaucrat can do to make sure things are maximally bad.”

I agree; the significant role played by Birx in the catastrophic national response to Covid has not received nearly enough attention.

Brought in from out of Nowhere…

From the video presentation, viewers learn that Birx was added to the White House’s Coronavirus Task Force as its coordinator in latter February 2020.

Birx worked closely with Task Force chairman Vice President Mike Pence, a man one suspects will not be treated well by future historians.

According to the documentary, “career bureaucrats” like Birx somehow seized control of the executive branch of government and were able to issue orders to mayors and governors which effectively “shut down the country.”

These bureaucrats were often incompetent in their prior jobs as was Birx, who’d previously served as a scientist (ha!) in the Army before leading the government’s effort to “fight AIDS in Africa” (via the PEPFAR Program).

When Birx was installed as coordinator of Covid Response she simply rehashed her own playbook for fighting AIDS in Africa, say the filmmakers.

The three tenets of this response were:

  1. “Treat every case of this virus as a killer.”

  2. “Focus on children,” who, the public was told, were being infected and hospitalized in large numbers and were a main conduit for spreading the virus.

  3. “Get to zero cases as soon as possible.” (The “Zero Covid” goal).

The documentary primarily uses quotes from Scott Atlas, the White House Task Force’s one skeptic, to show that all three tenets were false.

Argued Atlas: Covid was not a killer – or a genuine mortality risk – to “99.95 percent” of the population. Children had virtually zero risk of death or hospitalization from Covid. And there was no way to get to “zero cases.”

Atlas Didn’t Shrug, but was Ignored…

Furthermore, the documentary convincingly illustrates how the views of Atlas were ignored and how, at some point, his ability to speak to the press was curtailed or eliminated. 

For example, when Atlas organized a meeting for President Trump with Covid-response skeptics (including the authors of the Great Barrington Declaration) this meeting was schedule to last only five minutes.

The documentary also presents a report from the inspector general of the Department of State that was highly critical of Birx’s management style with the African “AIDS relief” program she headed. 

Among other claims, the report said she was “dictatorial” in her dealings with subordinates and often “issued threats” to those who disagreed with her approach.

Shockingly, this highly-critical report was published just a month before she was appointed medical coordinator of the Coronavirus Task Force.

A particularly distressing sound bite from Birx lets viewers hear her opinion on how controversial “guidance” might be implemented with little pushback.

According to Birx, she intentionally buried the more draconian elements of the lockdowns in text at the end of long documents, theorizing (correctly apparently) that most reporters or readers would just “skim” the document and would not focus on how extreme and unprecedented these mandates actually were.

The documentary points out that Birx’s prescriptions and those of President Trump were often in complete conflict.

Birx, according to the documentary, once pointed this out to Vice President Pence, who told her to keep doing what she believed.

Indeed, the Vice President gave Birx full use of Air Force 2 so she could more easily travel across the country, spreading her lockdown message to governors, mayors, and other influencers.

Several Covid skeptic writers, including Jeffrey Tucker of Brownstone Institute, have noted that President Trump himself went from an opponent of draconian lockdowns to an avid supporter of these responses in a period of just one or two days (the pivotal change happened on or around March 10th, 2020, according to Tucker).

Whoever or whatever caused this change in position, it does not seem to be a coincidence that this about-face happened shortly after Birx – a former military officer – was named to an important position on the Task Force.

(Personally, I don’t give Anthony Fauci a pass as I’ve always figured he’s a “dark master” at manipulating members of the science/medical/government complex to achieve his own desired results.)

This documentary highlights the crucial role played by Deborah Birx and, more generally, how unknown bureaucrats can make decisions that turn the world upside-down.

That is, most Americans probably think presidents are in charge, but, often, they’re really not. These real rulers of society, one suspects, would include members of the so-called Deep State, who have no doubt installed sycophants like Fauci and Birx in positions of power.

I definitely recommend this 24-minute video...

A Sample of Reader Comments…

I also enjoyed the Reader Comments that followed this video. The first comment is from my Brownstone colleague who brought this documentary to my attention:

“… As I said, things can change over the period of 20 years but in the case of Birx/Fauci, I do not believe so. I have never seen people entrenched in the bureaucracy change.”

Other comments from the people who have viewed the mini-documentary on YouTube:

“Pence needs to be held accountable.”

“What does Debbie’s bank account look like?”

“(The) final assessment of President Trump at the 23:30 mark is, while painful, accurate. He got rolled.”

“This is very hard to find on YouTube. You can literally search the title and it doesn’t come up.”

“Excellent summary, hope this goes viral. Lots of lessons to learn for future generations.”

“Eye opening. Great reporting.”

Post from One Month Ago…

“37 likes after 3 years of the most controversial and divisive action in recent history. How can this be?”

“Oh never mind. YouTube hid it from the public for years.”

“Probably hasn’t been taken down yet for that reason, relatively low views.”

“Thanks for this! Sounds like everyone below President Trump was on a power trip and I didn’t think it was possible to despise Pence more than I already do.”

“…the backing of CDC, legacy media, WHO and government schools, business folding in fear are ALL responsible. Accountability for every person and agency is paramount!”

“Should be noted that her work on AIDS in Africa was just as useless and damaging.”

“First, any mature, adult woman who speaks with that much vocal fry should be immediately suspect. And the glee with which she recounts her role at undermining POTUS is remarkable and repulsive. This woman should NEVER be allowed to operate the levers of power again.”

*  *  *

Republished from the author’s Substack

Tyler Durden Mon, 04/15/2024 - 17:00

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