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Fauci Rejects CDC Director’s “Impending Doom” View Of Pandemic

Fauci Rejects CDC Director’s "Impending Doom" View Of Pandemic

The old flip-flopper is back. Having supported CDC Director Walensky’s dystopian outlook for America unless we all "obey" ‘the science’ and hunker down just a little longer (2…

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Fauci Rejects CDC Director's "Impending Doom" View Of Pandemic

The old flip-flopper is back. Having supported CDC Director Walensky's dystopian outlook for America unless we all "obey" 'the science' and hunker down just a little longer (2 more weeks to flatten the curve?), Dr. Fauci has changed his mind now, telling CBS in an interview this morning that he is "not sure 'impending doom'" is the right word to describe the pandemic.

Andoffered his take on MLB's Opening Day...

Is this an April Fool's Joke? Is the plague actually improving or are we facing the end of the world?

As Contra Corner's David Stockman details below, America is indeed suffering from a dangerous plague – a plague of misanthropic fear-mongering from the likes of Dr. Fauci, the Scarf Lady and the Biden’s new CDC director, among countless others of the self-designated Virus Patrol.

All three took to the mainstream media in recent days, with new CDC director Rochelle Walensky getting positively teary-eyed as she allegedly veered off-script to sound yet another Covid Alarm:

“I’m going to reflect on the recurring feeling I have of impending doom,” Walensky said, appearing to hold back tears.

“We do not have the luxury of inaction. For the health of our country, we must work together now to prevent a fourth surge.”

What? Where? Wait!

Here’s the source of Doom. Well, if you have your magnifying glass handy you might possibly spot it – the squiggle down there in the yellow box below!

Actually, she was not nearly done. When it comes to paint by the numbers exaggeration and hysteria the following is hard to top.

Amazon Essentials Men&...Buy New $29.90(as of 03:24 EDT - Details)It seems that the reason for Walensky’s alarm is that from the winter-flu season peak on January 13th, when the 7-day moving average reported 251,912 so-called “new cases”, the 7-day rate had plummeted by 77.8% to 55,840 on March 15th, but as of March 28 it was down by only, um, 75.3%!

The nation is recording a seven-day average of about 57,000 new Covid-19 cases per day, a 7% jump over the last week, CDC Director Dr. Rochelle Walensky said during a White House news briefing on the pandemic.

You can’t make up this kind of calculated mendacity, including, presumably, the off-script scripted tears.

That’s especially because it’s now an established fact that upwards of 60-80% of these “new cases” are not medical cases at all: They are asymptomatic individuals who got swabbed and had their nasal secretions run to at 35-40+ CTs on the PCR test, which immense magnification systematically generates false positives based on harmless RNA fragments and dead viral debris.

Yet with only 15,000 to 20,000 actual infected cases per day at best, of which 95% will not result in serious illness, hospitalization or death, the head of the CDC is out yelling fire in the theater still another time.

“I remain deeply concerned about this trajectory,” Walensky said. “We have seen cases and hospital admissions move from historic declines to stagnations and increases. We know from prior surges that if we don’t control things now, there is a real potential for the epidemic curve to soar again.”

Walensky urged the public to “take this moment very seriously,” adding people should continue to wear masks, stay 6 feet apart and avoid crowds or traveling. 

“We can turn this around, but it will take all of us working together,” she added.

We have bolded the last sentence because that’s what the political class is really all about. They are forever searching out societal ills–some real, mostly imagined – that require state-orchestrated collective action to remedy. After all, that is how they gain power and pelf in the arena of politics and governance, and on that score the Covid-Hysteria was made to order.Amazon Essentials Wome...Buy New $22.90(as of 03:24 EDT - Details)

By contrast, under a regime of spontaneous markets and social order, tens of millions of uninfected or asymptomatic people would never be getting Covid tests in the first place, and they certainly would not have been quarantining or shutting-down their normal economic and social lives.

All of that flowed from the misbegotten predicate that the coronavirus was some kind of modern Black Plague equivalent, but with a hideously perverted twist: Namely, that to stop its spread the healthy and well should be isolated at home or via distancing and masks on the infinitesimal chance that they might unknowingly have a sufficient viral load to transmit the pathogen in the community.

The fact is, back in the more benighted times of earlier centuries, they quarantined the sick, not the well; and when people got sick from seriously dangerous pathogens, they stayed home because they were too sick to wander around the community.

Stated differently, in the face of serious general contagions, society didn’t need officialdom constantly beating the tom-toms to induce fear-based changes in behavior that were not warranted by the facts at hand.

To the contrary, in the midst of real pandemics, communities quickly apprehended the dangers and organized themselves to cope. And when the sick stayed home or were committed to treatment or isolation facilities, real contagions and viruses eventually burned themselves out.

Not this time. There was no spontaneous community defense because the Covid is lethal to only a small subset of the population, consisting of the very elderly with weak immune systems and the co-morbid already suffering from other life-threatening conditions.

Beyond that, the”science” provides no basis at all for the notion that healthy or asymptomatic people transmit the virus. The political class’ false project of “stopping the spread”, in fact, buried the real science which overwhelmingly ixnays the whacko theory that healthy people going about their ordinary business are stealthy vessels of disease and death.USHTH Black Waterproof...Best Price: $16.55Buy New $17.99(as of 03:24 EDT - Details)

Instead, Fauci et. al. have seized upon the prosaic mechanics of human activity centered around social congregation, which inherently generates the probability that a respiratory virus–whether relatively benign or deathly – will spread through the community, and called it “the science”.

But that is not the science of Covid at all, which actually says that for 95% of the population it is not a lethal pathogen, as we will amplify below.

Instead, “community spread” is just an obvious mechanical fact of social life that got peddled as the “science” of lockdowns and became the basis for the whole regime of economic-martial law that has been stood-up since March 2020.

In any event, the sheer destructive absurdity of the matter was crystallized this weekend by the 55-year government lifer and windbag, Anthony Fauci, who has single-handedly made a mockery of “the science” and the U.S. Constitution during the past 14 months.

Said the sainted Dr. Fauci on the weekend CBS show:

“When the children go out into the community, you want them to continue to wear masks when they’re interacting with groups or multiple households,” Fauci proclaimed during an appearance on CBS News.

Fauci added that “children can clearly wind up getting infected” even if other kids they play with have been vaccinated against coronavirus.

With respect to the bolded phrase, what in the world is this dope talking about?

Of course, kids get infected with all kinds of germs which pass-around the classrooms and playgrounds, but in the case of the Covid, few of them get sick, virtually none are hospitalized and, thankfully, a nearly invisible fraction become fatalities.Western Chief Women&rs...Best Price: $26.71Buy New $41.95(as of 03:24 EDT - Details)

Indeed, after a full year of this full-on Covid-Hysteria, here is what we know about the “kids”. To wit, there are 73.2 million of them in America (17-years and under), yet only 238 of them are reported by the CDC itself as being among “all deaths involving Covid-19″.

As a statistical matter that represents just 0.3 mortalities per 100,000 population. The tip-off that this is ultra-thin gruel by any standard can be illustrated many different ways, but here are three of them:

  1. For the same 17 years and younger population during the same period (weeks of February 1, 2020 to March 24, 2021), the mortality rate from all causes other that WITH-Covid was 51.9 per 100,000 or 160X higher;

  2. The WITH-Covid mortality rate for the truly vulnerable population 85-years and older was 2,460 per 100,000 or 7,500X higher.

  3. The pediatrics association estimates that kids account for 13% of Covid “cases”, but have accounted for only 0.05% of deaths – meaning that the survival rate is 99.993%.

Nor is that all. Even the CDC tables show that nearly 20% of the WITH-Covid deaths in this age cohort also included pneumonia; and that there were also 602 deaths from pneumonia that did not include a positive Covid test or physician’s diagnosis.

Stated differently, among the entire youthful population of 73.2 million, there were 194 deaths from pure Covid versus 602 cases from pure pneumonia and another 179 deaths attributable to influenza.

So why in the world is Dr. Fauci worried about children being “infected”?

The answer is simple: He isn’t.

His game is stopping the spread for its own sake, and taking 73 million children hostage to the dictates of the Virus Patrol is all in a day’s work.

In fact, when it comes to the science of picking statistical pepper out of what is self-evidently numeric fly-shit, Dr. Fauci has few peers.

Thus, he told his fawning CBS host on Sunday that 10,000 additional, mostly false positive, cases are a new reminder that normalization is still a grave danger. In fact, he allowed that maybe by mid-summer people can go back to baseball parks, but only if they sit far apart and wear a mask!

ANTHONY FAUCI: …I’ve said many times to you that when you’re coming down from a big peak and you reach a point and start to plateau, once you stay at that plateau, you’re really in danger of a surge coming up. And unfortunately, that’s what we’re starting to see. We got stuck at around 50,000 new cases per day, went up to 60,000 the other day, and that’s really a risk.

…What we’re likely seeing is because of things like spring break and pulling back on the mitigation methods that you’ve seen. Now, several states have done that. I believe it’s premature,” Fauci said.

“I would expect that as we get through the summer – late spring, early summer – there’s going to be a relaxation where you’re going to have more and more people who will be allowed into baseball parks, very likely separated with seating, very likely continuing to wear masks.”

We undercover the real motivation behind this blithering crackpottery below, but for want of doubt consider this data. The on age-adjusted deaths from all sources during the 2020 Year of the Covid is now in, and the thin green bar on the far right margin speaks for itself.

The age-adjusted death rate in the US was only a tad above its recent level, and actually much lower than it was during the entirety of the 105 years between 1900 and 2005. Yet we are still being told about Impending Doom and Sleepy Joe is calling upon governors of some of the Red States who have finally come to their senses to reimpose the mandatory mask requirement.

And that’s the Spoiler Alert. This whole Covid enchilada has not been about public health all along.

Its an excuse for increased social control and aggrandizement of the state that the political classes have opportunistically seized upon, and are now determined to perpetuate indefinitely with new variants, new pretexts and new assaults on constitutional liberty, fiscal sanity and free market prosperity.

Notwithstanding the above, we actually can imagine a pathogen which would be as deadly as Ebola, as transmissible as the worst strain of SARS-2 and a Grim Reaper of one and all, regardless of age, health status or prophylactic measures taken.

While that might justify a sweeping economic Lockdown and government campaign to stop the spread on the grounds that society was being literally invaded by an army of fatal pathogens, the crucial point is this: The Covid has now proven itself in spades to be just the opposite of that theoretical deathly contagion.

And for want of doubt, we don’t mean modestly dissimilar. We are talking about upside-down, black and white, opposite-end-of-the-earth different.

Truly, the data below tells you all you need to know as to why the Virus Patrol is and has been dead-wrong all alone. Sweeping nonparmaceutical interventions (NPIs) have been unjustified from the get-go, as has the relentless blunderbuss campaign by the arms of the state to stop the spread of the coronavirus dead-in-its-tracks.

The reason is simple. The Covid is a pathogenic bully that hones in with malice aforethought on the very most vulnerable segments of the population. That is, those exhibiting the immunological frailties of old age, life-threatening comorbidities or rare genetic predispositions for immune system overreaction to this viral interloper, especially in the form of cytokine storms where the human body essentially attacks and kills itself.

On the one hand, the proof that the Covid is not a universally deadly pathogen is in the aggregate pudding. Based on the overwhelming findings of serological studies (i.e. blood serum tests for antibodies), upwards of 125 million Americans have been infected to date, albeit most of this number have not been symptomatic or confirmed via the wholly unreliable PCR test.

Even among the 30 million who have tested positive – including many individuals who have tested positive multiple times in order to get free of government or employer restrictions – less than 10 million have been seriously ill, fewer than one million have been hospitalized, and even by the CDC’s expansive counting system, about 525,000 have died.

That computes to a 0.4% IFR (infection fatality rate), which ain’t no Black Plague or Ebola equivalent. Full stop.

Indeed, even at this most aggregated level, the Covid does not present as a marauding army of death. In no way shape or form does it merit the “deathly” prefix that has become embedded in the vocabulary and word processors of the mainstream narrative.

In fact, even when you use age as a crude proxy for health status, there are virtually no community-spread illnesses that have the kind of extreme skew to the least healthy as shown in the table below.

This is the mortality rate per 100,000 for the period from February 1, 2020 through March 24, 2021, and the mortality figures are extracted from the CDC’s own expansive count of WITH-Covid deaths.

Population/ WITH-Covid deaths/ rate per 100,000 by Age Cohort:

  • 0-17 Years: 73.2 million persons/ 238 deaths/ 0.33 per 100k;

  • 18-29 years: 53.6 million persons/ 1,916 deaths/ 3.6 per 100k;

  • 30-49 years: 84.5 million persons/ 20,717 deaths/ 24.5 per 100k;

  • 50-64 years: 62.9 million persons/78,883 deaths/ 125.4 per 100k;

  • 65-74 years: 31.5 million persons/ 115,381 deaths/ 366.4 per 100k;

  • 75-84 years: 16.0 million persons/ 146,310 deaths/ 916.2 per 100k;

  • 85+ years: 6.6 million persons/ 162,583 deaths/ 2,460.0 per 100k;

  • All ages: 328.2 million persons/ 526,028 deaths/ 160.3 per 100k.

In round terms, the above shows that 81% of all WITH-Covid deaths have been among the 16% of the population (54.1 million) 65 years and older. By contrast, the the 64.4% of the population under 50 years (211.4 million) accounted for just 22,900 or 4.4% of the WITH-Covid deaths tallied by the CDC.

Yet it is the under 50 years population – the Kids, the socially congregating 20-30 year olds and the core working age population 30-50 years – that has borne the brunt of the Lockdowns and NPIs. Self-evidently, these measures were not imposed for their own protection since their risks of death from Covid were infinitesimal compared to the ordinary risks of life.

As shown in the table below, for instance, the risk of death from all causes other than WITH-Covid during the last 14 months for the 18-29 years cohort was 183.1 per 100,000. That’s 51X greater than the 3.6 per 100,000 risk of dying from Covid during the same period for the 53.6 million members of this most socially active and interactive cohort of the US population.

Even in the case of the core working age population age 30-49, the all causes (other than Covid) risk of death was 283.3 per 100,000 or 12X greater than the incidence of WITH-Covid deaths (24.5 per 100k).

Of course, the Virus Patrol might argue that the WITH-Covid deaths were preventable by stern Lockdowns and other NPIs, while deaths from, say, heart disease or respiratory illnesses were not. In fact, that’s exactly what the Scarf Lady argued on a weekend show this past Sunday.

Had the Donald not been such a obstinate dolt, Dr. Birx essentially claimed, and strictly followed the advice of herself and Fauci et. Al, most of the WITH-Covid deaths would not have happened.

The “vast majority” of the almost 550,000 coronavirus deaths in the US could have been prevented if Donald Trump’s administration had acted earlier and with greater conviction…. “There were about 100,000 deaths that came from that original surge. All of the rest of them, in my mind, could have been mitigated or decreased substantially.”

If we were Sleepy Joe, we’d probably risk a chauvinism charge and say, c’mon woman!

Here is the seven-day moving average of deaths WITH-Covid for two of the most open states (Texas and Florida) compared to the the nation’s Lockdown capital of California. For the past 370 days, the curves have risen and fallen pretty much in tandem with the normal flu seasonality, and in recent months California has taken a turn for the worse relative to Texas and Florida.

Indeed, since Governor Abbott belatedly saw the light and opened Texas completely in early March, the data are so compelling as to make a complete fool of the Scarf Lady, as shown below:

Texas: 7-day new cases average:

  • March 2 (before): 6,663

  • March 28 (after): 3,320

Texas: 7-day new deaths average:

  • March 2 (before): 231;

  • March 28 (after): 107

The fact is, there is now overwhelming proof among both the states and among different countries that the vast disparities in Covid-control regimes didn’t make any difference in mortality and other health outcomes. Dr. Birx was not talking science, she was spouting political cant.

Internationally, the case of Sweden should finally tell Dr. Fauci, the Scarf Lady and the rest of the Virus Patrol to shut-up and go home. After 14 months of firmly resisting the Wuhan Lockdown Model that was foolishly adopted in the US, the UK and throughout much of Western Europe, half of Sweden should be dead by now if the egregious fear-mongering of the Virus Patrol was even remotely correct.

In fact, based on preliminary data from EU statistics agency Eurostat, Sweden had 7.7% more deaths in 2020 than its average for the preceding four years. By contrast, countries that opted for several periods of strict lockdowns, such as Spain and Belgium, had so-called excess mortality of 18.1% and 16.2% respectively.

In all, twenty-one of the 30 countries with available statistics had higher excess mortality outcomes than Sweden.

Here’s the thing. The misbegotten one-size fits all regime adopted by the Donald’s advisors in March 2020 didn’t happen because America’s admittedly lumbering Federal and local governments weren’t capable of targeting protective measures on the nation’s 54 million or so population of the most vulnerable Americans.

For crying out loud, the Federal government (via Medicare/Medicaid) actually knows the social security numbers, preferred physicians and health facilities and medical conditions of damn near every single American over 65 years.

It could have put on a full court press of notifications, advisories about health risks, prophylactics and treatments and provided financial support and protective services wherever warranted at a tiny fraction of the fiscal and economic costs that have been incurred by the NPI strategies.

So why wasn’t this targeted approach taken?

There is a very simple and deeply disturbing answer. To wit, there was nothing in this targeted approach for publicity-hounds and wanna be power players like Dr. Fauci and the Scarf Lady, who would have otherwise soldiered on in relative obscurity in the backwaters of the Federal public health apparatus.

Worse still, once these wanna be Federal power players bamboozled the Donald (easy enough to do) and basically redefined a targeted medical challenge as a sweeping, across-the-board public health crisis, the governors, mayors and other petty officials throughout the land were unleashed to impose economic martial law, and they did so on the basis of dubious and rubbery local statues.

Needless to say, this unconstitutional, unplanned, disorganized blunderbuss of interventions turned into a totalitarian nightmare within a matter of weeks.

Even then, there was no excuse. The data from the Covid-struck cruise ship called the Diamond Princess was already in, and it showed that among even a senior citizen-aged population of about 3,711 guests and crew, of which 712 (19%) were confirmed cases or became symptomatic or ill, only a tiny fraction needed hospital care and just 14 died.

That made for a IFR of just 0.4%, assuming all passengers were infected owing to close quarters at sea. At worst, the IFR was 2.0% if you assume the improbability that only the 712 passengers who were tested and diagnosed as Covid-positive had been infected.

Moreover, among the ship’s crew of 1,045 with a median age of 36 years, there were 145 positive cases, but zero deaths.

By contrast, among the 2,666 passengers on board with a median age of 69 years, there were 567 positive cases. Yet all of the fatalities were among these far older passengers, and virtually all of those who succumbed were in their 70s and 80s.

In short, when the 14th passenger, who was in his late 70s, died on April 14th, the entire profile of the Covid had been live fire tested and demarcated: It wasn’t a deathly pathogen for society as a whole, and it was fatal for just a small subset of the elderly population over 70 years.

Needless to say, the Diamond Princess lessons never got the time of day once the White House Coronavirus Task Force was up and running, and conducting it nightly reality TV show.

Then-and-there, the public health apparatchiks turned the Federal government’s Covid response into an all-of-society political crusade to accomplish the impossible: Namely, extinguish a novel respiratory virus that by its very nature was destined to spread to most of the population, and could have been permitted to do so had it been accompanied with protective measures targeted on the vulnerable.

Under that kind of regime, real medical science would have been the driver. We are referring to hundreds of thousands of trained physicians and health care institutions providing one-patient-at-a-time care and treatments. That is, the real science would have been brought to bear on sick patients – including the kind of ad hoc improvisations and off-label treatments that quickly emerge from the decentralized medical community when a novel medical threat arises.

As it happened, by contrast, we got a clumsy, sometimes brutal social control regime targeted mainly on the healthy from the public officials who were not remotely competent to manage anything as stunningly complex and interdependent as the American economy and social order. And whatever their ad hocery and constantly changing advice, rules and orders were based upon, it wasn’t “the science”.

Worse still, the pseudo-science behind the NPI regime quickly got hyper-politicized once the Donald discovered that he had been bamboozled and began to let loose with randomized doubts about the undertaking that he had authorized and sanctioned.

Accordingly, within a few weeks the most extreme form of Faucist public health nonsense became the sanctioned orthodoxy among the anti-Trump political class and media organs. And wearing a mask became the very badge of honor in a purported war on the Covid that actually amounted to a political war on the Trumpian Right.

If there were any doubts, Biden removed them this week when he called upon Red State governors to reinstate their mandatory mask orders, and adopted the same misbegotten language that was used in the state-aggrandizing War on Poverty by LBJ, War On Drugs by Nixon and War on Energy by Carter, among others.

“We still are in a war with this deadly virus,” he said. “And we’re bolstering our defenses, but this war is far from won.”

Of course, in these phony wars what amounts to statistical noise is transposed into heavy duty warnings, such as CDC Director Walensky’s cry of doom Monday morning that we are facing an impending 4th wave breakout owing to some tiny squiggles in the incoming case and mortality data.

Then again, if you can spot this incipient breakout in the chart below, your eyes are surely better than ours.

In fact, there is no uptick in the overwhelming majority of states, if such upticks of positive PCR tests results were meaningful, which they are not. Just six states, which are shown in color below, account for most of the national uptick, and these are the six most consistent and heavy duty Blue State Lockdown regimes!

Notwithstanding the meaningless statistical noise shown above, the establishment media has now been house-trained to replicate and amplify the false alarms issued by officialdom.

Here is the nonsense that the media megaphones at POLITICO were quick to issue upon Walensky’s doom pronouncement. Self-evidently, what is really transmissible is the mainstream party line, not the disease:

Covid strikes back – Pardon this interruption to the “everything is awesome” narrative. Because Covid-19 is surging again, leaving the CDC director with a sense of “impending doom” regarding a fourth wave in the pandemic.

Debbie Lai, chief operating officer of Covid Act Nowtold POLITICO Nightly’s Renuka Rayasam that the country’s Covid trajectory is deteriorating: “There may be a fourth surge underway, with cases now growing in two-thirds of states versus half before the weekend.”

The numbers: New cases jumped by 11 percent over the past week to a seven-day average of about 60,000 daily cases, according to an interagency memo dated March 29 and obtained by POLITICO.

Likewise, a WSJ paint-by-the-numbers story obsessed on the same trivia.

The US reported 507 deaths for Sunday, down from a day-earlier 741 but up from 447 a week earlier.

Well, here’s the fact of the matter. Every day about 8,200 American die on average, and more in the winter-early spring months. So the Sunday-to-Sunday difference cited by the WSJ amounts to 0.7% of the daily mortality average; it’s a statistical fluctuation, not news or information.

Needless to say, these statistical noise emissions – even though they are heralded with bated breath in the MSM – are still just plain noise. And they are also a testament to the utter lack of context in which Sleepy Joe’s war on this ostensibly “deadly virus” is being waged.

As indicated earlier, here is the mortality rates for the same seven age cohorts shown above – but this time for all causes of death except WITH-Covid. What it shows is the obvious point that mortality rates are a function of age, but that compared to the all-causes curve depicted below, the Covid skew to the very elderly is in a class all by itself.

To wit, the ratio of deaths from all causes other than Covid for the 85 and older population is 164X higher than for the 0-17 years cohort. And that’s not even in the same ballpark as the 7,455X ratio for the incidence of Covid deaths as between the oldest and youngest Americans.

Medical science and targeted help versus a blunderbuss non-science based political power grab is what the so-called Covid crisis has been about since the very beginning. It was another false crisis defined by the political class and their media subalterns to facilitate a further aggrandizement of the state.

All Causes Mortality Except Covid: # of deaths/rate per 100k, February 2020-March 2021:

  • 0-17 years: 70,731 deaths/96.6 per 100k;

  • 18-29 years: 98,083 deaths/183.1 per 100k;

  • 30-49 years: 239,400 deaths/283.3 per 100k;

  • 50-64 years: 581,170 deaths/923.8 per 100k;

  • 65-74 years: 694,765 deaths/2,206 per 100k;

  • 75-84 years: 840,052 deaths/5,260 per 100k;

  • 85 years & older: 1,045,660 deaths/ 15,819 per 100k;

  • All age groups: 3,509,979 deaths/ 1,069 per 100k

Nor are these data unique to the US. Covid is an elderly-assaulting bully the world over.

But rather than protection of the bottom two classes of the population, the Covid became an excuse for house arrest and economic and social disenfranchisement of the bulk of the population that was never in serious danger, as the chart below makes so stunningly clear.

Yet the apparatchiks who falsely seized power are not about to give it up – vaccinations, herd immunity and plunging cases notwithstanding.

That’s the real impending doom.

Tyler Durden Thu, 04/01/2021 - 09:25

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Acadia’s Nuplazid fails PhIII study due to higher-than-expected placebo effect

After years of trying to expand the market territory for Nuplazid, Acadia Pharmaceuticals might have hit a dead end, with a Phase III fail in schizophrenia…

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After years of trying to expand the market territory for Nuplazid, Acadia Pharmaceuticals might have hit a dead end, with a Phase III fail in schizophrenia due to the placebo arm performing better than expected.

Steve Davis

“We will continue to analyze these data with our scientific advisors, but we do not intend to conduct any further clinical trials with pimavanserin,” CEO Steve Davis said in a Monday press release. Acadia’s stock $ACAD dropped by 17.41% before the market opened Tuesday.

Pimavanserin, a serotonin inverse agonist and also a 5-HT2A receptor antagonist, is already in the market with the brand name Nuplazid for Parkinson’s disease psychosis. Efforts to expand into other indications such as Alzheimer’s-related psychosis and major depression have been unsuccessful, and previous trials in schizophrenia have yielded mixed data at best. Its February presentation does not list other pimavanserin studies in progress.

The Phase III ADVANCE-2 trial investigated 34 mg pimavanserin versus placebo in 454 patients who have negative symptoms of schizophrenia. The study used the negative symptom assessment-16 (NSA-16) total score as a primary endpoint and followed participants up to week 26. Study participants have control of positive symptoms due to antipsychotic therapies.

The company said that the change from baseline in this measure for the treatment arm was similar between the Phase II ADVANCE-1 study and ADVANCE-2 at -11.6 and -11.8, respectively. However, the placebo was higher in ADVANCE-2 at -11.1, when this was -8.5 in ADVANCE-1. The p-value in ADVANCE-2 was 0.4825.

In July last year, another Phase III schizophrenia trial — by Sumitomo and Otsuka — also reported negative results due to what the company noted as Covid-19 induced placebo effect.

According to Mizuho Securities analysts, ADVANCE-2 data were disappointing considering the company applied what it learned from ADVANCE-1, such as recruiting patients outside the US to alleviate a high placebo effect. The Phase III recruited participants in Argentina and Europe.

Analysts at Cowen added that the placebo effect has been a “notorious headwind” in US-based trials, which appears to “now extend” to ex-US studies. But they also noted ADVANCE-1 reported a “modest effect” from the drug anyway.

Nonetheless, pimavanserin’s safety profile in the late-stage study “was consistent with previous clinical trials,” with the drug having an adverse event rate of 30.4% versus 40.3% with placebo, the company said. Back in 2018, even with the FDA approval for Parkinson’s psychosis, there was an intense spotlight on Nuplazid’s safety profile.

Acadia previously aimed to get Nuplazid approved for Alzheimer’s-related psychosis but had many hurdles. The drug faced an adcomm in June 2022 that voted 9-3 noting that the drug is unlikely to be effective in this setting, culminating in a CRL a few months later.

As for the company’s next R&D milestones, Mizuho analysts said it won’t be anytime soon: There is the Phase III study for ACP-101 in Prader-Willi syndrome with data expected late next year and a Phase II trial for ACP-204 in Alzheimer’s disease psychosis with results anticipated in 2026.

Acadia collected $549.2 million in full-year 2023 revenues for Nuplazid, with $143.9 million in the fourth quarter.

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Four Years Ago This Week, Freedom Was Torched

Four Years Ago This Week, Freedom Was Torched

Authored by Jeffrey Tucker via The Brownstone Institute,

"Beware the Ides of March,” Shakespeare…

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Four Years Ago This Week, Freedom Was Torched

Authored by Jeffrey Tucker via The Brownstone Institute,

"Beware the Ides of March,” Shakespeare quotes the soothsayer’s warning Julius Caesar about what turned out to be an impending assassination on March 15. The death of American liberty happened around the same time four years ago, when the orders went out from all levels of government to close all indoor and outdoor venues where people gather. 

It was not quite a law and it was never voted on by anyone. Seemingly out of nowhere, people who the public had largely ignored, the public health bureaucrats, all united to tell the executives in charge – mayors, governors, and the president – that the only way to deal with a respiratory virus was to scrap freedom and the Bill of Rights. 

And they did, not only in the US but all over the world. 

The forced closures in the US began on March 6 when the mayor of Austin, Texas, announced the shutdown of the technology and arts festival South by Southwest. Hundreds of thousands of contracts, of attendees and vendors, were instantly scrapped. The mayor said he was acting on the advice of his health experts and they in turn pointed to the CDC, which in turn pointed to the World Health Organization, which in turn pointed to member states and so on. 

There was no record of Covid in Austin, Texas, that day but they were sure they were doing their part to stop the spread. It was the first deployment of the “Zero Covid” strategy that became, for a time, official US policy, just as in China. 

It was never clear precisely who to blame or who would take responsibility, legal or otherwise. 

This Friday evening press conference in Austin was just the beginning. By the next Thursday evening, the lockdown mania reached a full crescendo. Donald Trump went on nationwide television to announce that everything was under control but that he was stopping all travel in and out of US borders, from Europe, the UK, Australia, and New Zealand. American citizens would need to return by Monday or be stuck. 

Americans abroad panicked while spending on tickets home and crowded into international airports with waits up to 8 hours standing shoulder to shoulder. It was the first clear sign: there would be no consistency in the deployment of these edicts. 

There is no historical record of any American president ever issuing global travel restrictions like this without a declaration of war. Until then, and since the age of travel began, every American had taken it for granted that he could buy a ticket and board a plane. That was no longer possible. Very quickly it became even difficult to travel state to state, as most states eventually implemented a two-week quarantine rule. 

The next day, Friday March 13, Broadway closed and New York City began to empty out as any residents who could went to summer homes or out of state. 

On that day, the Trump administration declared the national emergency by invoking the Stafford Act which triggers new powers and resources to the Federal Emergency Management Administration. 

In addition, the Department of Health and Human Services issued a classified document, only to be released to the public months later. The document initiated the lockdowns. It still does not exist on any government website.

The White House Coronavirus Response Task Force, led by the Vice President, will coordinate a whole-of-government approach, including governors, state and local officials, and members of Congress, to develop the best options for the safety, well-being, and health of the American people. HHS is the LFA [Lead Federal Agency] for coordinating the federal response to COVID-19.

Closures were guaranteed:

Recommend significantly limiting public gatherings and cancellation of almost all sporting events, performances, and public and private meetings that cannot be convened by phone. Consider school closures. Issue widespread ‘stay at home’ directives for public and private organizations, with nearly 100% telework for some, although critical public services and infrastructure may need to retain skeleton crews. Law enforcement could shift to focus more on crime prevention, as routine monitoring of storefronts could be important.

In this vision of turnkey totalitarian control of society, the vaccine was pre-approved: “Partner with pharmaceutical industry to produce anti-virals and vaccine.”

The National Security Council was put in charge of policy making. The CDC was just the marketing operation. That’s why it felt like martial law. Without using those words, that’s what was being declared. It even urged information management, with censorship strongly implied.

The timing here is fascinating. This document came out on a Friday. But according to every autobiographical account – from Mike Pence and Scott Gottlieb to Deborah Birx and Jared Kushner – the gathered team did not meet with Trump himself until the weekend of the 14th and 15th, Saturday and Sunday. 

According to their account, this was his first real encounter with the urge that he lock down the whole country. He reluctantly agreed to 15 days to flatten the curve. He announced this on Monday the 16th with the famous line: “All public and private venues where people gather should be closed.”

This makes no sense. The decision had already been made and all enabling documents were already in circulation. 

There are only two possibilities. 

One: the Department of Homeland Security issued this March 13 HHS document without Trump’s knowledge or authority. That seems unlikely. 

Two: Kushner, Birx, Pence, and Gottlieb are lying. They decided on a story and they are sticking to it. 

Trump himself has never explained the timeline or precisely when he decided to greenlight the lockdowns. To this day, he avoids the issue beyond his constant claim that he doesn’t get enough credit for his handling of the pandemic.

With Nixon, the famous question was always what did he know and when did he know it? When it comes to Trump and insofar as concerns Covid lockdowns – unlike the fake allegations of collusion with Russia – we have no investigations. To this day, no one in the corporate media seems even slightly interested in why, how, or when human rights got abolished by bureaucratic edict. 

As part of the lockdowns, the Cybersecurity and Infrastructure Security Agency, which was and is part of the Department of Homeland Security, as set up in 2018, broke the entire American labor force into essential and nonessential.

They also set up and enforced censorship protocols, which is why it seemed like so few objected. In addition, CISA was tasked with overseeing mail-in ballots. 

Only 8 days into the 15, Trump announced that he wanted to open the country by Easter, which was on April 12. His announcement on March 24 was treated as outrageous and irresponsible by the national press but keep in mind: Easter would already take us beyond the initial two-week lockdown. What seemed to be an opening was an extension of closing. 

This announcement by Trump encouraged Birx and Fauci to ask for an additional 30 days of lockdown, which Trump granted. Even on April 23, Trump told Georgia and Florida, which had made noises about reopening, that “It’s too soon.” He publicly fought with the governor of Georgia, who was first to open his state. 

Before the 15 days was over, Congress passed and the president signed the 880-page CARES Act, which authorized the distribution of $2 trillion to states, businesses, and individuals, thus guaranteeing that lockdowns would continue for the duration. 

There was never a stated exit plan beyond Birx’s public statements that she wanted zero cases of Covid in the country. That was never going to happen. It is very likely that the virus had already been circulating in the US and Canada from October 2019. A famous seroprevalence study by Jay Bhattacharya came out in May 2020 discerning that infections and immunity were already widespread in the California county they examined. 

What that implied was two crucial points: there was zero hope for the Zero Covid mission and this pandemic would end as they all did, through endemicity via exposure, not from a vaccine as such. That was certainly not the message that was being broadcast from Washington. The growing sense at the time was that we all had to sit tight and just wait for the inoculation on which pharmaceutical companies were working. 

By summer 2020, you recall what happened. A restless generation of kids fed up with this stay-at-home nonsense seized on the opportunity to protest racial injustice in the killing of George Floyd. Public health officials approved of these gatherings – unlike protests against lockdowns – on grounds that racism was a virus even more serious than Covid. Some of these protests got out of hand and became violent and destructive. 

Meanwhile, substance abuse rage – the liquor and weed stores never closed – and immune systems were being degraded by lack of normal exposure, exactly as the Bakersfield doctors had predicted. Millions of small businesses had closed. The learning losses from school closures were mounting, as it turned out that Zoom school was near worthless. 

It was about this time that Trump seemed to figure out – thanks to the wise council of Dr. Scott Atlas – that he had been played and started urging states to reopen. But it was strange: he seemed to be less in the position of being a president in charge and more of a public pundit, Tweeting out his wishes until his account was banned. He was unable to put the worms back in the can that he had approved opening. 

By that time, and by all accounts, Trump was convinced that the whole effort was a mistake, that he had been trolled into wrecking the country he promised to make great. It was too late. Mail-in ballots had been widely approved, the country was in shambles, the media and public health bureaucrats were ruling the airwaves, and his final months of the campaign failed even to come to grips with the reality on the ground. 

At the time, many people had predicted that once Biden took office and the vaccine was released, Covid would be declared to have been beaten. But that didn’t happen and mainly for one reason: resistance to the vaccine was more intense than anyone had predicted. The Biden administration attempted to impose mandates on the entire US workforce. Thanks to a Supreme Court ruling, that effort was thwarted but not before HR departments around the country had already implemented them. 

As the months rolled on – and four major cities closed all public accommodations to the unvaccinated, who were being demonized for prolonging the pandemic – it became clear that the vaccine could not and would not stop infection or transmission, which means that this shot could not be classified as a public health benefit. Even as a private benefit, the evidence was mixed. Any protection it provided was short-lived and reports of vaccine injury began to mount. Even now, we cannot gain full clarity on the scale of the problem because essential data and documentation remains classified. 

After four years, we find ourselves in a strange position. We still do not know precisely what unfolded in mid-March 2020: who made what decisions, when, and why. There has been no serious attempt at any high level to provide a clear accounting much less assign blame. 

Not even Tucker Carlson, who reportedly played a crucial role in getting Trump to panic over the virus, will tell us the source of his own information or what his source told him. There have been a series of valuable hearings in the House and Senate but they have received little to no press attention, and none have focus on the lockdown orders themselves. 

The prevailing attitude in public life is just to forget the whole thing. And yet we live now in a country very different from the one we inhabited five years ago. Our media is captured. Social media is widely censored in violation of the First Amendment, a problem being taken up by the Supreme Court this month with no certainty of the outcome. The administrative state that seized control has not given up power. Crime has been normalized. Art and music institutions are on the rocks. Public trust in all official institutions is at rock bottom. We don’t even know if we can trust the elections anymore. 

In the early days of lockdown, Henry Kissinger warned that if the mitigation plan does not go well, the world will find itself set “on fire.” He died in 2023. Meanwhile, the world is indeed on fire. The essential struggle in every country on earth today concerns the battle between the authority and power of permanent administration apparatus of the state – the very one that took total control in lockdowns – and the enlightenment ideal of a government that is responsible to the will of the people and the moral demand for freedom and rights. 

How this struggle turns out is the essential story of our times. 

CODA: I’m embedding a copy of PanCAP Adapted, as annotated by Debbie Lerman. You might need to download the whole thing to see the annotations. If you can help with research, please do.

*  *  *

Jeffrey Tucker is the author of the excellent new book 'Life After Lock-Down'

Tyler Durden Mon, 03/11/2024 - 23:40

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Red Candle In The Wind

Red Candle In The Wind

By Benjamin PIcton of Rabobank

February non-farm payrolls superficially exceeded market expectations on Friday by…

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Red Candle In The Wind

By Benjamin PIcton of Rabobank

February non-farm payrolls superficially exceeded market expectations on Friday by printing at 275,000 against a consensus call of 200,000. We say superficially, because the downward revisions to prior months totalled 167,000 for December and January, taking the total change in employed persons well below the implied forecast, and helping the unemployment rate to pop two-ticks to 3.9%. The U6 underemployment rate also rose from 7.2% to 7.3%, while average hourly earnings growth fell to 0.2% m-o-m and average weekly hours worked languished at 34.3, equalling pre-pandemic lows.

Undeterred by the devil in the detail, the algos sprang into action once exchanges opened. Market darling NVIDIA hit a new intraday high of $974 before (presumably) the humans took over and sold the stock down more than 10% to close at $875.28. If our suspicions are correct that it was the AIs buying before the humans started selling (no doubt triggering trailing stops on the way down), the irony is not lost on us.

The 1-day chart for NVIDIA now makes for interesting viewing, because the red candle posted on Friday presents quite a strong bearish engulfing signal. Volume traded on the day was almost double the 15-day simple moving average, and similar price action is observable on the 1-day charts for both Intel and AMD. Regular readers will be aware that we have expressed incredulity in the past about the durability the AI thematic melt-up, so it will be interesting to see whether Friday’s sell off is just a profit-taking blip, or a genuine trend reversal.

AI equities aside, this week ought to be important for markets because the BTFP program expires today. That means that the Fed will no longer be loaning cash to the banking system in exchange for collateral pledged at-par. The KBW Regional Banking index has so far taken this in its stride and is trading 30% above the lows established during the mini banking crisis of this time last year, but the Fed’s liquidity facility was effectively an exercise in can-kicking that makes regional banks a sector of the market worth paying attention to in the weeks ahead. Even here in Sydney, regulators are warning of external risks posed to the banking sector from scheduled refinancing of commercial real estate loans following sharp falls in valuations.

Markets are sending signals in other sectors, too. Gold closed at a new record-high of $2178/oz on Friday after trading above $2200/oz briefly. Gold has been going ballistic since the Friday before last, posting gains even on days where 2-year Treasury yields have risen. Gold bugs are buying as real yields fall from the October highs and inflation breakevens creep higher. This is particularly interesting as gold ETFs have been recording net outflows; suggesting that price gains aren’t being driven by a retail pile-in. Are gold buyers now betting on a stagflationary outcome where the Fed cuts without inflation being anchored at the 2% target? The price action around the US CPI release tomorrow ought to be illuminating.

Leaving the day-to-day movements to one side, we are also seeing further signs of structural change at the macro level. The UK budget last week included a provision for the creation of a British ISA. That is, an Individual Savings Account that provides tax breaks to savers who invest their money in the stock of British companies. This follows moves last year to encourage pension funds to head up the risk curve by allocating 5% of their capital to unlisted investments.

As a Hail Mary option for a government cruising toward an electoral drubbing it’s a curious choice, but it’s worth highlighting as cash-strapped governments increasingly see private savings pools as a funding solution for their spending priorities.

Of course, the UK is not alone in making creeping moves towards financial repression. In contrast to announcements today of increased trade liberalisation, Australian Treasurer Jim Chalmers has in the recent past flagged his interest in tapping private pension savings to fund state spending priorities, including defence, public housing and renewable energy projects. Both the UK and Australia appear intent on finding ways to open up the lungs of their economies, but government wants more say in directing private capital flows for state goals.

So, how far is the blurring of the lines between free markets and state planning likely to go? Given the immense and varied budgetary (and security) pressures that governments are facing, could we see a re-up of WWII-era Victory bonds, where private investors are encouraged to do their patriotic duty by directly financing government at negative real rates?

That would really light a fire under the gold market.

Tyler Durden Mon, 03/11/2024 - 19:00

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